# US 6,731,981 B1 · Heart stimulator for administering antithrombus therapy

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- Number: US 6,731,981 B1
- Document ID: US6731981B1
- Status: Granted
- Kind: B1
- Application number: 09/530,384
- Filed: 2000-04-27
- Granted: 2004-05-04
- Earliest claimed: 1997-10-28
- Assignees: Pacesetter, Inc.
- Inventors: Tryggve Hemmingsson; Jakub Hirschberg
- Web page: https://patentgrep.com/patent/US6731981B1

## CPC

- A61N 1/3962: {in combination with another heart therapy}
- A61N 1/39622: {Pacing therapy}
- A61N 1/395: {for treating atrial fibrillation}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

A heart stimulator has a stimulation energy delivering assembly, including at least one lead adapted for implantation in contact with cardiac tissue, and an atrial arrhythmia detector, and a control unit connected to the stimulation energy delivering assembly and to the detector. The control unit controls the stimulation energy delivering assembly to deliver at least one atrial arrhythmia abolishing therapy and, if continued atrial arrhythmia is detected, to deliver antithrombus stimulation energy pulses of lower energy than a defibrillation shock, but with different timing and with sufficient energy for producing atrial contraction for increasing hemodynamic blood transportation away from the atrium and for preventing thrombi formation in the atrium. For a patient suffering from a chronic or paroxysmal non-curable atrial arrhythmia, the control unit controls the stimulation energy delivering assembly to deliver the antithrombus energy without any preceding arrhythmia abolishing therapy.

## Claims

### Claim 1

A heart stimulator comprising: a stimulation energy delivering assembly including at least one lead, adapted for implantation in contact with cardiac tissue, for delivering stimulation energy via said lead, an atrial arrhythmia detector, and a control unit connected to said detector and to said stimulation energy delivering assembly for controlling said stimulation energy delivering assembly to deliver at least one primary atrial arrhythmia abolishing stimulus via said lead and after a predetermined time, if continued atrial arrhythmia is detected by said detector, antithrombus stimulation energy in a form selected from the group consisting of pulses and burst of pulses of different timing and energy levels from the primary stimulus for producing an atrial contraction that promotes hemodynamic blood transportation away from the atrium and prevents thrombi formation in the atrium.

### Claim 2 (depends on 1)

The heart stimulator according to claim 1 wherein said control unit includes a time delay stage for delaying delivery of said antithrombus stimulation energy for a predetermined time delay after one of a detected onset of atrial arrhythmia by said detector and after a terminated unsuccessful abolishing of atrial arrhythmia by said primary stimulus.

### Claim 3 (depends on 2)

The heart stimulator according to claim 2, wherein said time delay is programmable.

### Claim 4 (depends on 2)

The heart stimulator according to claim 2, wherein said predetermined time delay is at least 24 hours.

### Claim 5 (depends on 1)

The heart stimulator according to claim 1, wherein said control unit is manually actuatable for manual determination of a time of delivery of said antithrombus stimulation energy.

### Claim 6 (depends on 1)

The heart stimulator according to claim 1 wherein said atrial arrhythmia detector is a P-wave detector.

### Claim 7 (depends on 1)

The heart stimulator according to claims 1 wherein said atrial arrhythmia detector detects atrial arrhythmia from sensed R-R interval variations.

### Claim 8 (depends on 1)

The heart stimulator according to claim 1 wherein said antithrombus stimulation energy is sufficient for causing a contraction in at least a part of atrial muscular tissue.

### Claim 9 (depends on 1)

The heart stimulator according to claim 1 comprising a programming unit for programming a morphology of said pulses or bursts of pulses.

### Claim 10 (depends on 9)

The heart stimulator according to claim 9, wherein said programming unit programs a time interval between consecutive antithrombus stimulation pulses or consecutive bursts of antithrombus stimulation pulses.

### Claim 11 (depends on 1)

The heart stimulator according to claim 1 wherein said control unit controls said energy delivering assembly to said deliver antithrombus stimulation energy as a continuous pulse of DC current.

### Claim 12 (depends on 1)

The heart stimulator according to claim 1 wherein said control unit controls said stimulation energy delivering assembly to periodically deliver said antithrombus stimulation energy.

### Claim 13 (depends on 12)

The heart stimulator according to claim 12, wherein said control unit controls said energy delivering assembly to deliver said antithrombus stimulation energy at a frequency between twice a day and every other heartbeat.

### Claim 14 (depends on 1)

The heart stimulator according to claim 1 wherein said control unit includes synchronizing means for synchronizing delivery of said antithrombus stimulation energy with a cardiac cycle, detected by sad detector, to optimize atrial drainage.

### Claim 15 (depends on 14)

The heart stimulator according circuitry controls to claim 14, wherein said synchronizing circuitry controls said stimulation energy delivery assembly to deliver said antithrombus stimulation energy in a phase of the cardiac cycle separated from a vulnerable phase of the ventricle.

### Claim 16 (depends on 14)

The heart stimulator according to claim 14, wherein said synchronizing circuit controls said stimulation energy delivery assembly to deliver said pulses or bursts of pulses respectively separated by a plurality of cardiac cycles.

### Claim 17 (depends on 14)

The heart stimulator according to claim 14 said synchronizing circuit controls said stimulation energy delivery assembly to deliver said pulses or bursts of pulses before a QRS complex in the cardiac cycle.

### Claim 18 (depends on 1)

The heart stimulator according to claim 1 wherein said stimulation energy delivery assembly includes two electrodes selected from the group consisting of transvascular electrodes and extravascular electrodes.

### Claim 19 (depends on 1)

The heart stimulator according to claim 1 wherein said lead is adapted for implantation into the atrium and is selected from the group consisting of leads and bipolar leads.

### Claim 20 (depends on 1)

The heart stimulator according to claim 1 wherein said lead is adapted for implantation into the coronary vein system including coronary sinus ostium area.

### Claim 21 (depends on 1)

The heart stimulator according to claim 1 wherein said lead is selected from the group consisting of leads adapted for implantation in the right ventricle and leads adapted for implantation on the right ventricular wall.

### Claim 22 (depends on 21)

The heart stimulator according to claim 21, wherein said lead is a lead implantable in the right ventricle, and wherein said stimulation energy delivery assembly delivers antithrombus stimulation pulses or bursts of antithrombus stimulation pulses as ventriculo-atrial crosstalk.

### Claim 23 (depends on 22)

The heart stimulator according to claim 22, wherein said control unit controls said stimulation energy delivering assembly to deliver said crosstalk antithrombus stimulation pulses or said crosstalk bursts of antithrombus stimulation pulses in a time interval between a QRS-complex and a T-wave.

### Claim 24 (depends on 1)

The heart stimulator according to claim 1 wherein said lead is an atrial multipolar electrode lead for multisite antithrombus therapy of the atrium.

### Claim 25 (depends on 1)

The heart stimulator according to claims 1 wherein said stimulation energy delivering assembly includes a plurality of electrode leads for multisite epicardial antithrombus therapy.

### Claim 26 (depends on 25)

The heart stimulator according to claim 25, wherein said plurality of leads is adapted for unichamber antithrombus therapy.

### Claim 27 (depends on 25)

The heart stimulator according to claim 25, wherein said plurality of leads is adapted for multichamber antithrombus therapy.

### Claim 28 (depends on 25)

The heart stimulator according to claim 25, wherein said plurality of electrode leads comprises epicardial electrodes for respective implantation at sites selected from the group consisting of on the right left atrial wall, the right ventricular wall and the left ventricular wall.

### Claim 29 (depends on 1)

The heart stimulator according to claim 1 wherein said lead is a lead implantable in the left atrium, and wherein said stimulation energy delivering assembly delivers antithrombus stimulation pulses or bursts of antithrombus stimulation pulses as inter-atrial crosstalk.

### Claim 30 (depends on 1)

The heart stimulator according to claim 1 wherein said stimulation energy delivering assembly is adapted for delivery, via said lead, of antithrombus stimulation energy in the right ventricle outflow tract or in the vicinity of the valvular area.

### Claim 31 (depends on 1)

The heart stimulator according to claim 1 wherein said control unit controls said stimulation energy delivering assembly to deliver said antithrombus stimulation energy in an antithrombus mode, and wherein said control unit also controls said stimulation energy delivering assembly, in a pacing mode, to deliver pacing pulses to cardiac tissue via said lead.

### Claim 32 (depends on 1)

The heart stimulator according to claim 1 wherein said control unit controls said stimulation energy delivering assembly to deliver said antithrombus stimulation energy in an antithrombus mode, and wherein said control unit also controls said stimulation energy delivering assembly, in a defibrillation mode, to deliver defibrillation pulses to cardiac tissue via said lead.

### Claim 33 (depends on 1)

The heart stimulator according to claim 1 wherein said control unit controls said antithrombus stimulation energy assembly to deliver said antithrombus stimulation energy as a single continuous DC pulse combined with antiarrhythmic therapy.

### Claim 34

A heart stimulator comprising: a stimulation energy delivering assembly including at least one lead, adapted for implantation in contact with cardiac tissue, for delivering stimulation energy via said lead, an atrial arrhythmia detector, and a control unit connected to said detector and to said stimulation energy delivering assembly for controlling said stimulation energy delivering assembly to deliver antithrombus stimulation energy in a form selected from the group consisting of pulses and burst of pulses of lower energy than a defibrillation shock for producing atrial contraction for increasing hemodynamic blood transportation away from the atrium and preventing thrombi formation in the atrium.

### Claim 35 (depends on 34)

The heart stimulator according to claim 34 wherein said control unit includes a time delay stage for delaying delivery of said antithrombus stimulation energy for a predetermined time delay after one of a detected onset of atrial arrhythmia by said detector and after a terminated unsuccessful abolishing of atrial arrhythmia by said primary stimulus.

### Claim 36 (depends on 35)

The heart stimulator according to claim 35, wherein said time delay is programmable.

### Claim 37 (depends on 35)

The heart stimulator according to claim 35, wherein said predetermined time delay is at least 24 hours.

### Claim 38 (depends on 34)

The heart stimulator according to claim 34, wherein said control unit is manually actuatable for manual determination of a time of delivery of said antithrombus stimulation energy.

### Claim 39 (depends on 34)

The heart stimulator according to claim 34 wherein said atrial arrhythmia detector is a P-wave detector.

### Claim 40 (depends on 34)

The heart stimulator according to claims 34 wherein said atrial arrhythmia detector detects atrial arrhythmia from sensed R-R interval variations.

### Claim 41 (depends on 34)

The heart stimulator according to claim 34 wherein said antithrombus stimulation energy is sufficient for causing a contraction in at least a part of atrial muscular tissue.

### Claim 42 (depends on 34)

The heart stimulator according to claim 34 comprising a programming unit for programming a morphology of said pulses or bursts of pulses.

### Claim 43 (depends on 42)

The heart stimulator according to claim 42, wherein said programming unit programs a time interval between consecutive antithrombus stimulation pulses or consecutive bursts of antithrombus stimulation pulses.

### Claim 44 (depends on 34)

The heart stimulator according to claim 34 wherein said control unit controls said energy delivering assembly to said deliver antithrombus stimulation energy as a continuous pulse of DC current.

### Claim 45 (depends on 34)

The heart stimulator according to claim 34 wherein said control unit controls said stimulation energy delivering assembly to periodically deliver said antithrombus stimulation energy.

### Claim 46 (depends on 45)

The heart stimulator according to claim 45, wherein said control unit controls said energy delivering assembly to deliver said antithrombus stimulation energy at a frequency between twice a day and every other heartbeat.

### Claim 47 (depends on 34)

The heart stimulator according to claim 34 wherein said control unit includes synchronizing means for synchronizing delivery of said antithrombus stimulation energy with a cardiac cycle, detected by sad detector, to optimize atrial drainage.

### Claim 48 (depends on 47)

The heart stimulator according circuitry controls to claim 47, wherein said synchronizing circuitry controls said stimulation energy delivery assembly to deliver said antithrombus stimulation energy in a phase of the cardiac cycle separated from a vulnerable phase of the ventricle.

### Claim 49 (depends on 47)

The heart stimulator according to claim 47, wherein said synchronizing circuit controls said stimulation energy delivery assembly to deliver said pulses or bursts of pulses respectively separated by a plurality of cardiac cycles.

### Claim 50 (depends on 47)

The heart stimulator according to claim 47 said synchronizing circuit controls said stimulation energy delivery assembly to deliver said pulses or bursts of pulses before a QRS complex in the cardiac cycle.

### Claim 51 (depends on 34)

The heart stimulator according to claim 34 wherein said stimulation energy delivery assembly includes two electrodes selected from the group consisting of transvascular electrodes and extravascular electrodes.

### Claim 52 (depends on 34)

The heart stimulator according to claim 34 wherein said lead is adapted for implantation into the atrium and is selected from the group consisting of leads and bipolar leads.

### Claim 53 (depends on 34)

The heart stimulator according to claim 34 wherein said lead is adapted for implantation into the coronary vein system including coronary sinus ostium area.

### Claim 54 (depends on 34)

The heart stimulator according to claim 34 wherein said lead is selected from the group consisting of leads adapted for implantation in the right ventricle and leads adapted for implantation on the right ventricular wall.

### Claim 55 (depends on 54)

The heart stimulator according to claim 54, wherein said lead is a lead implantable in the right ventricle, and wherein said stimulation energy delivery assembly delivers antithrombus stimulation pulses or bursts of antithrombus stimulation pulses as ventriculo-atrial crosstalk.

### Claim 56 (depends on 55)

The heart stimulator according to claim 55, wherein said control unit controls said stimulation energy delivering assembly to deliver said crosstalk antithrombus stimulation pulses or said crosstalk bursts of antithrombus stimulation pulses in a time interval between a QRS-complex and a T-wave.

### Claim 57 (depends on 34)

The heart stimulator according to claim 34 wherein said lead is an atrial multipolar electrode lead for multisite antithrombus therapy of the atrium.

### Claim 58 (depends on 34)

The heart stimulator according to claims 34 wherein said stimulation energy delivering assembly includes a plurality of electrode leads for multisite epicardial antithrombus therapy.

### Claim 59 (depends on 58)

The heart stimulator according to claim 58, wherein said plurality of leads is adapted for unichamber antithrombus therapy.

### Claim 60 (depends on 58)

The heart stimulator according to claim 58, wherein said plurality of leads is adapted for multichamber antithrombus therapy.

### Claim 61 (depends on 58)

The heart stimulator according to claim 58, wherein said plurality of electrode leads comprises epicardial electrodes for respective implantation at sites selected from the group consisting of on the right left atrial wall, the right ventricular wall and the left ventricular wall.

### Claim 62 (depends on 34)

The heart stimulator according to claim 34 wherein said lead is a lead implantable in the left atrium, and wherein said stimulation energy delivering assembly delivers antithrombus stimulation pulses or bursts of antithrombus stimulation pulses as inter-atrial crosstalk.

### Claim 63 (depends on 34)

The heart stimulator according to claim 34 wherein said stimulation energy delivering assembly is adapted for delivery, via said lead, of antithrombus stimulation energy in the right ventricle outflow tract or in the vicinity of the valvular area.

### Claim 64 (depends on 34)

The heart stimulator according to claim 34 wherein said control unit controls said stimulation energy delivering assembly to deliver said antithrombus stimulation energy in an antithrombus mode, and wherein said control unit also controls said stimulation energy delivering assembly, in a pacing mode, to deliver pacing pulses to cardiac tissue via said lead.

### Claim 65 (depends on 34)

The heart stimulator according to claim 34 wherein said control unit controls said stimulation energy delivering assembly to deliver said antithrombus stimulation energy in an antithrombus mode, and wherein said control unit also controls said stimulation energy delivering assembly, in a defibrillation mode, to deliver defibrillation pulses to cardiac tissue via said lead.

### Claim 66 (depends on 34)

The heart stimulator according to claim 34 wherein said control unit controls said antithrombus stimulation energy assembly to deliver said antithrombus stimulation energy as a single continuous DC pulse combined with antiarrhythmic therapy.
