Micro integrated cardiac pacemaker and distributed cardiac pacing system

• US 8,027,729 B2
• Filed: 08/04/2003
• Issued: 09/27/2011
• Est. Priority Date: 08/05/2002
• Status: Expired due to Fees

• Current Assignee: Fujikin Incorporated, National Cerebral And Cardiovascular Center
• Original Assignee: Fujikin Incorporated, National Cerebral And Cardiovascular Center
• Inventors: Sugimachi, Masaru, Sunagawa, Kenji, Inagaki, Masashi
• Primary Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US10/523,538
• Publication Number:
  US 20050288717A1
• Time in Patent Office: 2,976 Days
• Field of Search: 607/35, 607/36
• US Class Current: 607/36
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3785 generated by biological activity or substance, e.g. body movement
• CPC Class Codes: H01M 8/16 Biochemical fuel cells, i.e. cells in which microorganisms function as catalysts
• CPC Class Codes: Y02E 60/50 Fuel cells

Abstract

A micro integrated cardiac pacemaker includes a control unit for outputting a control signal according to cardiograph information, heart stimulating means for stimulating heart tissue in response to the control signal, cardiograph information extracting means for extracting cardiograph information and outputting it to the control unit, and a power supply unit for supplying drive power. The power supply unit is a biological fuel cell that takes out electrons by oxidation of a biological fuel. The biological fuel cell includes an anode and a cathode. An oxidase of a biological fuel and a mediator are immobilized on the cathode. Blood and/or body fluid are used as an electrolytic solution, and a biological fuel and oxygen in the blood and/or the fluid are used. The biological fuel cell is attached to the end of a catheter and implanted into the heart, and the catheter is withdrawn, without incising the breast.

Claims

1. A first ultra miniature integrated cardiac pacemaker adapted to be part of a distributed cardiac pacing system comprising at least one second ultra miniature integrated cardiac pacemaker, wherein the first ultra miniature integrated cardiac pacemaker is adapted to be implanted into a heart of a patient, the first ultra miniature integrated cardiac pacemaker comprising:

a) a control unit that outputs at least one control signal;

b) a heart stimulating means that responds to the control signal and electrically stimulates heart tissue;

c) an electrocardiographic information detecting means that detects a plurality of electrocardiographic information and outputs the electrocardiographic information to the control unit;

d) a transmitting means to modulate the electrocardiographic information and control signal and to send the modulated electrocardiographic information and the modulated control signal outside of the first ultra miniature integrated cardiac pacemaker via a plurality of carrier waves to at least one of the second ultra miniature integrated cardiac pacemakers adapted to be implanted into the heart of the patient;

e) a receiving means to demodulate information transmitted from at least one of the second ultra miniature integrated cardiac pacemakers adapted to be implanted into the heart; and

f) a power unit that supplies the driving power;

wherein the first ultra miniature integrated cardiac pacemaker requires no chest incision, and can be implanted into a heart by attaching the first ultra miniature integrated cardiac pacemaker to a tip of a catheter and extracting the catheter after implantation;

wherein the first ultra miniature integrated cardiac pacemaker is designed such that information sent from at least one of the second ultra miniature integrated cardiac pacemakers is input into the control unit after the information is demodulated by the receiving means;

wherein the control unit of the first ultra miniature integrated cardiac pacemaker outputs the control signal based on information selected from the group consisting of a) information sent from at least one of the second ultra miniature integrated cardiac pacemakers;

b) electrocardiographic information; and

c) a combination of a) and b);

wherein the control unit of the first ultra miniature integrated cardiac pacemaker outputs the control signal based on the information sent from at least one of the second ultra miniature integrated cardiac pacemakers to pace the heart and mimic a natural physiological state of the heart;

wherein the control unit includes a stimulation timing determining means that determines the timing of stimulation to generate control signals, and a stimulation timing changing means that changes the timing of stimulation to generate control signals;

wherein the control unit changes the stimulation timing when certain conditions are fulfilled;

wherein the power unit is a biological fuel cell that extracts electrons from oxidative reactions of biological fuels;

wherein the biological fuel cell is composed of an anode and a cathode;

wherein the anode comprises an anode electrode and an immobile layer formed on a surface of the anode electrode by immobilization of mediators and oxidative enzymes for biological fuels, wherein said immobile layer prevents oxygen existing in a biological body from contacting said anode electrode;

wherein the cathode comprises a cathode electrode and a coating material formed on a surface of the cathode electrode, wherein the cathode electrode is composed of a catalyst to enhance a reaction involving reduction of oxygen, and wherein said coating material is capable of preventing permeation of reactive substances other than oxygen and allowing permeation of oxygen and hydrogen ions;

wherein the biological fuel cell uses an electrolyte solution selected from the group consisting of blood;

body fluid; and

blood and body fluid, and utilizes biological fuels and oxygen in the electrolyte solution without the need for a container to contain the electrolyte solution or a metabolic product; and

wherein said anode and said cathode are adapted to contact the electrolyte solution.

2. The ultra miniature integrated cardiac pacemaker of claim 1, wherein the first ultra miniature integrated cardiac pacemaker is adapted to be placed on an atrium or a ventricle of the heart of the patient.

3. A distributed cardiac pacing system comprising the ultra miniature integrated cardiac pacemaker of claim 1 and at least one second ultra miniature integrated cardiac pacemaker adapted to be placed on an atrium or a ventricle of the heart of the patient.

4. A first ultra miniature integrated cardiac pacemaker adapted to be part of a distributed cardiac pacing system comprising at least one second ultra miniature integrated cardiac pacemaker, wherein the first ultra miniature integrated cardiac pacemaker is adapted to be implanted into a heart of a patient, the first ultra miniature integrated cardiac pacemaker comprising:

a) a control unit that outputs at least one control signal;

b) a heart stimulating means that responds to the control signal and electrically stimulates heart tissue;

c) an electrocardiographic information detecting means that detects a plurality of electrocardiographic information and outputs the electrocardiographic information to the control unit;

d) a transmitting means to modulate the electrocardiographic information and control signal and to send the modulated electrocardiographic information and the modulated control signal via a plurality of carrier waves to at least one of the second ultra miniature integrated cardiac pacemakers adapted to be implanted into the heart of the patient;

e) a receiving means to demodulate information transmitted from at least one of the second ultra miniature integrated cardiac pacemakers; and

f) a power unit that supplies the driving power;

wherein the first ultra miniature integrated cardiac pacemaker requires no chest incision, and can be implanted into a heart by attaching the first ultra miniature integrated cardiac pacemaker to a tip of a catheter and extracting the catheter after implantation;

wherein the first ultra miniature integrated cardiac pacemaker is designed such that the information sent from at least one of the second ultra miniature integrated cardiac pacemakers is input into the control unit after the information is demodulated by the receiving means;

wherein the control unit of the first ultra miniature integrated cardiac pacemaker outputs the control signal based on the information sent from at least one of the second ultra miniature integrated cardiac pacemakers adapted to be implanted into the heart to pace the heart and mimic a natural physiological state of the heart;

wherein the control unit includes a stimulation timing determining means that determines the timing of stimulation to generate control signals, and a stimulation timing changing means that changes the timing of stimulation to generate control signals;

wherein the control unit changes the stimulation timing when certain conditions are fulfilled;

wherein the power unit is a biological fuel cell that extracts electrons from oxidative reactions of biological fuels;

wherein the biological fuel cell is composed of an anode and a cathode;

wherein the anode comprises an anode electrode and an immobile layer formed on a surface of the anode electrode by immobilization of mediators and oxidative enzymes for biological fuels, wherein said immobile layer prevents oxygen existing in a biological body from contacting said anode electrode;

wherein the cathode comprises a cathode electrode and a coating material formed on a surface of the cathode electrode, wherein the cathode electrode is composed of a catalyst to enhance a reaction involving reduction of oxygen, and wherein said coating material is capable of preventing permeation of reactive substances other than oxygen and allowing permeation of oxygen and hydrogen ions;

wherein the biological fuel cell uses an electrolyte solution selected from the group consisting of blood;

body fluid; and

blood and body fluid, and utilizes biological fuels and oxygen in the electrolyte solution without the need for a container to contain the electrolyte solution or a metabolic product; and

wherein said anode and said cathode are adapted to contact the electrolyte solution.

5. The pacemaker of claim 4, wherein the control unit outputs the control signal based on additional information comprising electrocardiographic information.

6. The ultra miniature integrated cardiac pacemaker of claim 4, wherein the first ultra miniature integrated cardiac pacemaker is adapted to be placed on an atrium or a ventricle of the heart of the patient.

7. A distributed cardiac pacing system comprising the ultra miniature integrated cardiac pacemaker of claim 4 and at least one second ultra miniature integrated cardiac pacemaker adapted to be placed on an atrium or a ventricle of the heart of the patient.