Source: http://www.google.es/patents/US9713723
Timestamp: 2017-12-17 02:49:39
Document Index: 8314750

Matched Legal Cases: ['art.\n11', 'art.\n12', 'art.\n13', 'art.\n14', 'art.\n15', 'art.\n16', 'art.\n17', 'art.\n34', 'Application No. 119', 'art 20', 'art, 15', 'art 15', 'Application No. 99931435', 'Application No. 06759102', 'Application No. 05853465', 'Application No. 04106247', 'Application No. 01928181', 'Application No. 04719312', 'Application No. 05853465', 'Application No. 01928181', 'Application No. 04106247', 'Application No. 05853465', 'Application No. 97929478', 'Application No. 06759102', 'Application No. 06759102', 'Application No. 04719312', 'Application No. 5571', 'Application No. 5571', 'Application No. 2014', 'Application No. 5571', 'Application No. 5571', 'Application No. 5571', 'Application No. 5571', 'Application No. 5571', 'Application No. 04719312', 'Application No. 200480012687', 'Application No. 200480012687', 'Application No. 200480012687', 'Application No. 200480012687', 'Application No. 200480012687', 'Application No. 200480027283', 'Application No. 200480012687', 'Application No. 128955', 'Application No. 200480012687', 'Application No. 11', 'Application No. 200480012687', 'Application No. 05853465', 'Application No. 06759102', 'Application No. 05853465', 'Application No. 04719312', 'Application No. 01928181', 'Application No. 2007', 'Application No. 09', 'Application No. 200480012687', 'Application No. 200480012687']

Patente US9713723 - Signal delivery through the right ventricular septum - Google Patentes
A method is provided for use with a human subject. The method includes accessing a cardiac site via a vena cava of the subject, and alleviating heart failure of the subject by applying to the cardiac site, during a refractory period of the site, a refractory-period signal that affects the left ventricle...http://www.google.es/patents/US9713723?utm_source=gb-gplus-sharePatente US9713723 - Signal delivery through the right ventricular septum
Número de publicación US9713723 B2
Número de solicitud US 11/673,812
También publicado como US20070162079
Número de publicación 11673812, 673812, US 9713723 B2, US 9713723B2, US-B2-9713723, US9713723 B2, US9713723B2
Inventores Itzhak Shemer, Yuval Mika, Benny Rousso
Cesionario original Impulse Dynamics Nv
Citas de patentes (551), Otras citas (420), Clasificaciones (11), Eventos legales (4)
US 9713723 B2
A method is provided for use with a human subject. The method includes accessing a cardiac site via a vena cava of the subject, and alleviating heart failure of the subject by applying to the cardiac site, during a refractory period of the site, a refractory-period signal that affects the left ventricle of the subject's heart. Other embodiments are also described.
1. Apparatus for applying a signal to a heart of a human subject, comprising: one or more electrodes, configured to be passed by a catheter through a vena cava of the subject and coupled to a cardiac site of the right ventricle or the right ventricle septum of the subject; a circuitry for determining a start time of or a time within a refractory period; and a control unit, configured to alleviate heart failure of the subject by driving the one or more electrodes to apply to said cardiac site, during said determined refractory period of the site, a signal that directly affects a left ventricle of the heart and is non-excitatory thereto.
2. The apparatus according to claim 1, wherein the one or more electrodes are configured to be implanted from a right ventricle of the subject into an inter-ventricular septum of the subject.
3. The apparatus according to claim 2, wherein at least one of the electrodes is configured to penetrate to a depth of 5-10 mm in the septum.
4. The apparatus according to claim 2, wherein at least one of the electrodes is configured to penetrate to a depth of 10-20 mm in the septum.
5. The apparatus according to claim 2, wherein at least one of the electrodes is configured to penetrate to a depth of 20-25 mm in the septum.
6. The apparatus according to claim 2, wherein at least one of the electrodes is configured to penetrate through the septum and emerge in the left ventricle.
7. The apparatus according to claim 2, wherein at least one of the electrodes comprises a coil electrode.
8. The apparatus according to claim 2, wherein at least one of the electrodes comprises a screw electrode, configured to be screwed into the septum.
9. The apparatus according to claim 8, wherein the screw electrode comprises a bipolar screw electrode.
10. The apparatus according to claim 1, wherein the control unit is operative to configure the signal to be capable of modifying contractility of a portion of the heart.
11. The apparatus according to claim 10, wherein the control unit is operative to configure the signal to be capable of increasing contractility of the left ventricle of the heart.
12. The apparatus according to claim 10, wherein the control unit is operative to configure the signal to be capable of modifying contractility of an inter-ventricular septum of the heart.
13. The apparatus according to claim 10, wherein the control unit is operative to configure the signal to be capable of modifying contractility of a right ventricle of the heart.
14. The apparatus according to claim 10, wherein the control unit is operative to configure the signal to be capable of increasing contractility of the portion of the heart.
15. The apparatus according to claim 10, wherein the control unit is operative to configure the signal to be capable of decreasing contractility of the portion of the heart.
16. The apparatus according to claim 15, wherein the control unit is operative to configure the signal to be capable of decreasing contractility of an inter-ventricular septum of the heart.
17. The apparatus according to claim 1, wherein the control unit is configured to drive the one or more electrodes to apply a pacing signal to the site during an excitatory period of a cardiac cycle, and to apply the refractory-period signal during a refractory period of the same cardiac cycle.
18. The apparatus according to claim 17, wherein the control unit is configured to drive the one or more electrodes to apply the refractory-period signal with no delay following application of the pacing signal.
19. The apparatus according to claim 17, wherein the control unit is configured to drive the one or more electrodes to apply the refractory-period signal following a delay after application of the pacing signal.
20. The apparatus according to claim 1, wherein the control unit is configured to receive a sensed signal indicative of electrical activity of the heart at a sensing site, and to drive the one or more electrodes to apply the refractory-period signal in response to the sensed signal.
21. The apparatus according to claim 20, comprising a sensing electrode which is separate from the one or more electrodes, wherein the control unit is configured to receive the sensed signal from the sensing electrode.
22. The apparatus according to claim 20, wherein the control unit is configured to receive the sensed signal from one of the one or more electrodes, and to drive the one of the one or more electrodes to apply the refractory-period signal in response to the sensed signal.
23. The apparatus according to claim 1, wherein the control unit configures the refractory-period signal to include a series of pulses which are greater than 8 mA.
24. The apparatus according to claim 23, wherein the control unit configures the refractory-period signal to include a series of pulses which are greater than 10 mA.
25. The apparatus according to claim 1, wherein the control unit is configured to drive the one or more electrodes to apply the refractory-period signal chronically.
26. The apparatus according to claim 25, wherein the control unit is operative to configure the refractory-period signal to engender long-term alleviation of the heart failure.
27. The apparatus according to claim 1, wherein the control unit configures the refractory-period signal to include a plurality of pulses that are greater than 1 mJ.
28. The apparatus according to claim 27, wherein the control unit configures the refractory-period signal to include a plurality of pulses that are greater than 5 mJ.
29. The apparatus according to claim 1, wherein the control unit is configured to detect arrhythmia of the heart, and to drive at least one of the one or more electrodes to apply an anti-arrhythmic signal in response thereto.
30. The apparatus according to claim 29, wherein the control unit is configured to detect fibrillation of the heart, and to drive the at least one of the electrodes to apply a defibrillating signal to the cardiac site in response to detecting fibrillation.
31. The apparatus according to claim 1, wherein said cardiac site is a cardiac site of the right ventricle septum of the subject.
32. The apparatus according to claim 31, wherein the signal applied to the right ventricle septum of the subject increases contractility efficacy of the left ventricle.
33. The apparatus according to claim 1, wherein the control unit is operative to configure the refractory-period signal such that it increases cardiac output of the heart.
34. The apparatus according to claim 1, wherein the control unit is configured to drive the one or more electrodes to apply a series of biphasic pulses.
35. The apparatus according to claim 1, wherein the control unit is configured to drive the one or more electrodes to apply a series of generally square pulses.
36. The apparatus according to claim 1, wherein the control unit is configured to drive the one or more electrodes to apply a series of pulses at a rate greater than 50 Hz.
37. The apparatus according to claim 1, wherein the control unit is configured to drive the one or more electrodes to apply a series of pulses at a rate less than 100 Hz.
38. The apparatus according to claim 1, wherein the control unit is configured to drive the one or more electrodes to apply a series of pulses at a rate between 50 Hz and 100 Hz.
39. The apparatus according to claim 1, wherein the control unit is configured to drive the one or more electrodes to apply the signal to a site at or adjacent to an intersection of an interventricular septum and a right ventricular free wall.
40. The apparatus according to claim 1, wherein at least one of the electrodes comprises a material selected from the group consisting of: titanium coated with iridium oxide, titanium coated with titanium nitride, platinum iridium coated with iridium oxide, platinum iridium coated with titanium nitride, platinum iridium coated with sintered platinum, titanium, platinum iridium, and pyrolytic carbon.
41. The apparatus according to claim 1, wherein at least one of the electrodes is shaped to define an effective external surface area of between 30 mm2 and 250 mm2.
42. The apparatus according to claim 1, wherein at least one of the electrodes has an impedance that is between 50 Ohms and 1000 Ohms.
43. The apparatus according to claim 1, wherein at least one of the electrodes has an impedance that is between 200 Ohms and 700 Ohms.
44. The apparatus according to claim 1, wherein at least one of the electrodes has a capacitance between 300 and 3000 microfarads.
45. The apparatus according to claim 1, wherein the refractory-period signal includes an excitatory-tissue control (ETC) signal, and wherein the control unit is configured to drive the one or more electrodes to apply the ETC signal to the cardiac site.
46. The apparatus according to claim 1, wherein the one or more electrodes comprise a plurality of electrodes, configured to be implanted at a respective plurality of cardiac sites.
47. The apparatus according to claim 1, wherein the one or more electrodes comprise a bipolar electrode.
48. The apparatus according to claim 1, wherein the one or more electrodes comprise a monopolar electrode.
49. The apparatus according to claim 1, wherein the control unit configures the refractory-period signal to include a series of biphasic pulses.
50. The apparatus according to claim 1, including a plurality of electrodes, and wherein the control system is operable to apply different signals to one or more of the electrodes.
The present application is a continuation-in-part of U.S. Ser. No. 10/672,385, filed Sep. 26, 2003, which is:
a continuation of commonly assigned U.S. Ser. No. 09/848,535, filed May 3, 2001, now abandoned, which is based upon commonly assigned U.S. 60/202,382, filed May 4, 2000;
a continuation-in-part of co-pending, commonly assigned U.S. Ser. No. 10/188,726, filed Jul. 2, 2002, which is a continuation of commonly assigned U.S. Ser. No. 09/254,903, filed Mar. 12, 1999, now U.S. Pat. No. 6,415,178, which is a U.S. National Phase Patent Application of PCT/IL97/00233, filed Jul. 9, 1997, which is based upon U.S. 60/026,392, filed Sep. 16, 1996, and Israeli Patent Application 119,261, filed Sep. 17, 1996; and
a continuation-in-part of co-pending, commonly assigned U.S. Ser. No. 10/039,845, filed Oct. 23, 2001, which is a continuation of U.S. Ser. No. 09/563,544, filed May 1, 2000, now U.S. Pat. No. 6,363,279, which is a continuation of U.S. Ser. No. 09/101,723, filed Aug. 13, 1998, now U.S. Pat. No. 6,317,631, which is a U.S. National Phase filing of PCT/IL97/00012, filed Jan. 8, 1997, which is based upon U.S. 60/009,769, filed Jan. 11, 1996, U.S. 60/011,117, filed Feb. 5, 1996, U.S. 60/026,392, filed Sep. 16, 1996, U.S. Ser. No. 08/595,365, filed Feb. 1, 1996, now U.S. Pat. No. 5,738,096, and Israeli Patent Application No. 119,261, filed Sep. 17, 1996.
US Patent Application Publication 2002/0055764 to Malonek et al., which is assigned to the assignee of the present patent application and is incorporated herein by reference, describes a lead for modifying the activity of a tissue, particularly the heart. Electrodes are provided for performing sensing and/or signal delivery functions. A control unit controls the parameters of the electric field provided by signal delivery electrodes to prevent the generation of a propagation action potential in the tissue.
The following patent references are incorporated herein by reference: U.S. Pat. No. 6,714,823, WO 99/55412, U.S. Pat. No. 6,064,906, WO 98/41144, U.S. Pat. No. 5,772,604, WO 97/49143, and U.S. Pat. No. 5,350,419.
It is a finer object of some aspects of the present invention to provide improved methods and apparatus for enhancing cardiac performance.
An ETC signal is an example of a “refractory-period signal,” which is a signal applied to a cardiac site during the refractory period of the cardiac site.
It is noted that these embodiments of the present invention simplify the procedure of applying electrical signals to modulate cardiac contraction. It is known in the art to apply pacing signals to the left ventricle by the difficult procedure of passing a catheter through the coronary veins. It is also known in the art to make an incision in a patients chest so as to implant pacing electrodes on the heart. It is further known in the art to pace both ventricles via an electrode placed on the interventricular septum, whereby pacing pulses generated by the electrode cause an activation wave to propagate through the septum, through normal conduction pathways of the heart. These prior art techniques differ from preferred embodiments of the present invention in that the prior art is directed towards stimulating one or both ventricles to contract, while these embodiments of the present invention provide means for modulating the mechanical behavior of the septum itself, substantially without inducing new action potentials.
In a preferred embodiment, one or more mechanical sensors, e.g., force transducers, strain gauges, pressure gauges, and/or motion sensors, are positioned in a vicinity of the heart, and are coupled to send mechanical-sensor signals to the control unit indicative of aspects of the heart's functioning. Alternatively or additionally, one or more physiological sensors, e.g., for measuring mixed venous oxygen saturation (SvO2) or thoracic electrical impedance, send physiological-sensor signals to the control unit. The various sensor signals serve as feedback to enable the control unit to iteratively adjust the ETC signal applied to the septum, so as to cause the sensor signals to converge to desired values. Alternatively or additionally, other sensors, such as sensing electrodes, blood pressure sensors, or flow tranducers, are coupled to the heart or elsewhere on the patient's body, and send signals to the control unit which are used in determining modifications to parameters of the energy applied to the heart.
There is also provided, in accordance with a-preferred embodiment of the present invention, apparatus for applying a signal to a heart of a human subject, including:
There is additionally provided, in accordance with an embodiment of the invention, a method for use with a human subject having a heart, including:
accessing a cardiac site via a vena cava of the subject; and
alleviating heart failure of the subject by applying to the cardiac site, during a refractory period of the site, a refractory-period signal that affects a left ventricle of the heart.
In an embodiment, applying the refractory-period signal includes applying an excitatory-tissue control (ETC) signal.
In an embodiment, applying the refractory-period signal includes configuring the refractory-period signal to increase cardiac output of the heart.
In an embodiment, accessing the cardiac site includes accessing a plurality of cardiac sites via the vena cava, and applying the signal to the cardiac site includes applying energy to each of the cardiac sites.
In an embodiment, accessing the cardiac site via the vena cava includes guiding an electrode through a right ventricle of the subject.
In an embodiment, applying the signal includes applying the signal during a bipolar signal application period.
In an embodiment, applying the signal includes applying the signal during a monopolar signal application period.
In an embodiment, applying the refractory-period signal includes applying a series of biphasic pulses.
In an embodiment, applying the refractory-period signal includes applying a series of generally square pulses.
In an embodiment, applying the refractory-period signal includes applying a series of pulses at a rate greater than 50 Hz.
In an embodiment, applying the refractory-period signal includes applying a series of pulses at a rate less than 100 Hz.
In an embodiment, applying the refractory-period signal includes applying a series of pulses at a rate between 50 Hz and 100 Hz.
In an embodiment, applying the refractory-period signal includes applying the refractory-period signal to a site at or adjacent to an intersection of an interventricular septum and a right ventricular free wall of the heart.
In an embodiment, applying the refractory-period signal includes chronically applying the refractory-period signal.
In an embodiment, chronically applying includes configuring the refractory-period signal to engender long-term alleviation of the heart failure.
In an embodiment, the method includes applying a pacing signal to the site during an excitatory period of a cardiac cycle, and applying the refractory-period signal includes applying the refractory-period signal during a refractory period of the same cardiac cycle.
In an embodiment, applying the pacing signal includes applying the pacing signal with no delay following applying the refractory-period signal.
In an embodiment, applying the pacing signal includes applying the pacing signal following a delay after applying the refractory-period signal.
In an embodiment, applying the refractory-period signal includes applying a plurality of pulses that are greater than 1 mJ.
In an embodiment, applying the plurality of pulses includes applying a plurality of pulses that are greater than 5 mJ.
In an embodiment, the method includes sensing electrical activity of the heart at a sensing site, and applying the refractory-period signal in response to the sensing.
In an embodiment, the sensing site is different from the cardiac site, and sensing the electrical activity includes sensing at the sensing site that is different from the cardiac site.
In an embodiment, the sensing site includes the cardiac site, sensing includes sensing using an electrode, and applying the refractory-period signal includes applying the refractory-period signal through the electrode.
In an embodiment, the method includes detecting arrhythmia of the heart, and applying an anti-arrhythmic signal to the cardiac site in response thereto.
In an embodiment, detecting the arrhythmia includes detecting fibrillation of the heart, and applying the anti-arrhythmic signal includes applying a defibrillating signal to the cardiac site in response to the detecting of the fibrillation.
In an embodiment, accessing the cardiac site includes implanting an electrode from a right ventricle of the subject into an interventricular septum of the subject.
In an embodiment, implanting includes implanting a distal tip of the electrode to a depth of 5-10 mm in the septum.
In an embodiment, implanting includes implanting a distal tip of the electrode to a depth of 10-20 mm in the septum.
In an embodiment, implanting includes implanting a distal tip of the electrode to a depth of 20-25 mm in the septum.
In an embodiment, implanting includes implanting the electrode such that a distal tip of the electrode passes through the septum and protrudes into the left ventricle.
In an embodiment, the electrode includes a coil electrode, and implanting the electrode includes implanting the coil electrode.
In an embodiment, implanting the electrode includes screwing the electrode into the septum.
In an embodiment, the electrode includes a bipolar electrode, and screwing the electrode includes screwing the bipolar electrode into the septum.
In an embodiment, applying the refractory-period signal includes applying a series of pulses which are greater than 8 mA.
In an embodiment, applying the refractory-period signal includes applying a series of pulses which are greater than 10 mA.
In an embodiment, applying the refractory-period signal includes configuring the signal to be capable of modifying contractility of the left ventricle of the heart.
In an embodiment, configuring the refractory-period signal includes configuring the signal to be capable of modifying contractility of an interventricular septum of the heart.
In an embodiment, configuring the refractory-period signal includes configuring the signal to be capable of modifying contractility of a right ventricle of the heart.
In an embodiment, configuring the refractory-period signal includes configuring the signal to be capable of increasing contractility of the left ventricle of the heart.
In an embodiment, configuring the refractory-period signal includes configuring the signal to be capable of decreasing contractility of a portion of the heart.
In an embodiment, configuring the refractory-period signal to be capable of decreasing the contractility includes configuring the signal to be capable of decreasing contractility of an interventricular septum of the heart.
There is yet additionally provided, in accordance with an embodiment of the invention, apparatus for applying a signal to a heart of a human subject, including:
a set of one or more electrodes, configured to be passed through a vena cava of the subject and coupled to a cardiac site; and
a control unit, configured to alleviate heart failure of the subject by driving the electrode set to apply to the cardiac site, during a refractory period of the site, a refractory-period signal that affects a left ventricle of the heart.
In an embodiment, the control unit is configured to configure the refractory-period signal to increase cardiac output of the heart.
In an embodiment, the control unit is configured to drive the electrode set to apply a series of biphasic pulses.
In an embodiment, the control unit is configured to drive the electrode set to apply a series of generally square pulses.
In an embodiment, the control unit is configured to drive the electrode set to apply a series of pulses at a rate greater than 50 Hz.
In an embodiment, the control unit is configured to drive the electrode set to apply a series of pulses at a rate less than 100 Hz.
In an embodiment, the control unit is configured to drive the electrode set to apply a series of pulses at a rate between 50 Hz and 100 Hz.
In an embodiment, the control unit is configured to drive the electrode set to apply the signal to a site at or adjacent to an intersection of an interventricular septum and a right ventricular free wall.
In an embodiment, at least one of the electrodes includes a material selected from the group consisting of: titanium coated with iridium oxide, titanium coated with titanium nitride, platinum iridium coated with iridium oxide, platinum iridium coated with titanium nitride, platinum iridium coated with sintered platinum, titanium, platinum iridium, and pyrolytic carbon.
In an embodiment, at least one of the electrodes is shaped to define an effective external surface area of between 30 mm2 and 250 mm2.
In an embodiment, at least one of the electrodes has an impedance that is between 50 ohm and 1000 ohm.
In an embodiment, at least one of the electrodes has an impedance that is between 200 ohm and 700 ohm.
In an embodiment, at least one of the electrodes has a capacitance between 300 and 300 microfarads.
In an embodiment, the refractory-period signal includes an excitatory-tissue control (ETC) signal, and the control unit is configured to drive the electrode set to apply signal to the cardiac site.
In an embodiment, the one or more electrodes include a plurality of electrodes, configured to be implanted at a respective plurality of cardiac sites.
In an embodiment, the electrode set includes a bipolar electrode.
In an embodiment, the electrode set includes a monopolar electrode.
In an embodiment, the control unit configures the refractory-period signal to include a series of biphasic pulses.
In an embodiment, the control unit is configured to configure the signal to be capable of modifying contractility of a portion of the heart.
In an embodiment, the control unit is configured to configure the signal to be capable of increasing contractility of the left ventricle of the heart.
In an embodiment, the control unit is configured to configure the signal to be capable of modifying contractility of an interventricular septum of the heart.
In an embodiment, the control unit is configured to configure the signal to be capable of modifying contractility of a right ventricle of the heart.
In an embodiment, the control unit is configured to configure the signal to be capable of increasing contractility of the portion of the heart.
In an embodiment, the control unit is configured to configure the signal to be capable of decreasing contractility of the portion of the heart.
In an embodiment, the control unit is configured to configure the signal to be capable of decreasing contractility of an interventricular septum of the heart.
In an embodiment, the control unit configures the refractory-period signal to include a series of pulses which are greater than 8 mA.
In an embodiment, the control unit configures the refractory-period signal to include a series of pulses which are greater than 10 mA.
In an embodiment, the control unit is configured to drive the electrode set to apply the refractory-period signal chronically.
In an embodiment, the control unit is configured to configure the refractory-period signal to engender long-term alleviation of the heart failure.
In an embodiment, the control unit is configured to drive the electrode set to apply a pacing signal to the site during an excitatory period of a cardiac cycle, and to apply the refractory-period signal during a refractory period of the same cardiac cycle.
In an embodiment, the control unit is configured to drive the electrode set to apply the refractory-period signal with no delay following application of the pacing signal.
In an embodiment, the control unit is configured to drive the electrode set to apply the refractory-period signal following a delay after application of the pacing signal.
In an embodiment, the control unit configures the refractory-period signal to include a plurality of pulses that are greater than 1 mJ.
In an embodiment, the control unit configures the refractory-period signal to include a plurality of pulses that are greater than 5 mJ.
In an embodiment, the control unit is configured to receive a sensed signal indicative of electrical activity of the heart at a sensing site, and to drive the electrode set to apply the refractory-period signal in response to the sensed signal.
In an embodiment, the apparatus includes a sensing electrode which is not an electrode from the electrode set, and the control unit is configured to receive the sensed signal from the sensing electrode.
In an embodiment, the control unit is configured to receive the sensed signal from one of the one or more electrodes in the electrode set, and to drive the one of the one or more electrodes to apply the refractory-period signal in response to the sensed signal.
In an embodiment, the control unit is configured to detect arrhythmia of the heart, and to drive at least one of the electrodes in the electrode set to apply an anti-arrhythmic signal in response thereto.
In an embodiment, the control unit is configured to detect fibrillation of the heart, and to drive the at least one of the electrodes to apply a defibrillating signal to the cardiac site in response to detecting fibrillation.
In an embodiment, the electrode set is configured to be implanted from a right ventricle of the subject into an interventricular septum of the subject.
In an embodiment, at least one of the electrodes is configured to penetrate to a depth of 5-10 mm in the septum.
In an embodiment, at least one of the electrodes is configured to penetrate to a depth of 10-20 mm in the septum.
In an embodiment, at least one of the electrodes is configured to penetrate to a depth of 20-25 mm in the septum.
In an embodiment, at least one of the electrodes is configured to penetrate through the septum and emerge in the left ventricle.
In an embodiment, at least one of the electrodes includes a coil electrode.
In an embodiment, at least one of the electrodes includes a screw electrode, configured to be screwed into the septum.
In an embodiment, the screw electrode includes a bipolar screw electrode.
FIG. 1A is a schematic illustration of cardiac control apparatus 18, which applies electrical energy to improve the performance of the heart 20 of a patient, in accordance with a preferred embodiment of the present invention. Apparatus 18 preferably comprises an implantable or external control unit 90, which applies an ETC signal through a set of one or more electrodes 98 to the heart. (For clarity, connections between control unit 90 and the various electrodes are not shown).
Preferably, a catheter 68 is used to convey a screw electrode 65, or other type of electrode, through the right ventricle 30 to a site on the interventricular septum 22 to which the electrode is attached. Alternatively or additionally, a catheter 66 conveys an electrode 69 through the right ventricle to be fixed to the septum, and/or conveys an electrode 67 into the right ventricle, where it is in electrical contact with electrodes 65 and 69 through the blood in the right ventricle. In a preferred embodiment one or more electrodes are placed at or adjacent to the intersection of the septum and the right ventricular free wall.
For the purposes of this embodiment of the present invention, block 84 typically modifies a set of controllable parameters of the ETC signal, responsive to the measured parameters, in accordance with values in a look-up table and/or pre-programmed formulae stored in an electronic memory of control unit 90. The controllable parameter may comprise, for example, ETC signal timing, magnitude and offset. Preferably, the controllable parameters are conveyed by block 84 to a signal generation block 86 of control unit 90, which generates, responsive to the parameters, electrical signals that are applied by electrodes 98 to the heart. Block 86 preferably comprises amplifiers, isolation units, and other standard circuitry known in the art of electrical signal generation.
In a preferred embodiment, the ETC signal is applied in a vicinity of a site where standard pacing pulses are applied. Preferably, the ETC signal is applied through the same electrode as that through which the standard pacing pulse is applied, approximately 1-250 ms thereafter. Further preferably, the ETC signal is applied approximately 20-250 ms after the pacing pulse.
It is also believed that similar results can be obtained in humans, mutatis mutandis. It is further believed that these embodiments of the present invention can produce, at least to some extent, long-term effects which are likely to alleviate or cure aspects of some common cardiac pathologies, such as congestive heart failure (CHF). These effects are expected to derive from more effective use of the heart muscle, whereby systemic demands on the heart are reduced. Moreover, damage to other organs of the body is reduced, because of the increase in blood perfusion.
It is believed that other signal application protocols would also be successful in enhancing cardiac performance, in combination with or in the absence of some of the stimulation and sensing protocols described hereinabove. In a preferred embodiment the ETC signal is applied at a plurality of sites on the interventricular septum, for example, on an anterior and a posterior aspect thereof. Alternatively or additionally, the ETC signal is applied generally simultaneously, or in alternation, at one or more of the following sites: the posterior septum, the anterior septum, the anterior wall of the right ventricle, the free wall of the right ventricle, and the posterior-inferior left ventricular free wall.
In an embodiment, embodiments of the present invention are practiced using methods and apparatus described in US Patent Application Publication 2002/0055764 to Malonek et al., which is incorporated herein by reference.
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the the present invention includes both combinations and sub-combinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art which would occur to persons skilled in the art upon reading the foregoing description.
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Clasificación internacional A61N1/365, A61N1/32, A61N1/368, A61N1/362
Clasificación cooperativa A61N1/3627, A61N1/36564, A61N1/32, A61N1/368, A61N1/36557, A61N1/36585, A61N1/36542
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