Source: https://insight.rpxcorp.com/pat/US20070078490A1
Timestamp: 2019-10-14 08:24:26
Document Index: 290792038

Matched Legal Cases: ['art.\n13', 'art.\n14', 'art.\n21', 'art.\n49', 'Application No. 60', 'Application No. 60', 'Application No. 60']

Patent US 20070078490A1
US 20070078490A1
Filed: 09/27/2006
Est. Priority Date: 12/21/2004
1. A method for stimulating cardiac tissue, said method comprising:
placing a pacing lead to be in contact with the heart of a patient at a first cardiac stimulation site, implanting a receiver-stimulator at a second cardiac stimulation site, connecting the pacing lead to an external pacemaker, generating an electrical pacing pulse from an external pacemaker and applying the pacing pulse to the pacing lead, wherein said electrical pacing pulse delivers cardiac stimulation energy to the first cardiac stimulation site, generating acoustic energy, based on detecting the electrical pacing pulse, using an externally located acoustic energy generator coupled to the patient; and
receiving said acoustic energy at the second cardiac stimulation site, wherein said acoustic energy is converted into cardiac stimulation energy based on both energy and signal information included in the generated acoustic energy.
Systems including an implantable receiver-stimulator and an external controller-transmitter system are used for leadless acute stimulation of the heart, particularly after heart surgery. Cardiac pacing and arrhythmia control is accomplished with one or more implantable receiver-stimulators and an external system that alternatively includes the use of an external pacemaker. Receiver-stimulators are implanted in the heart during surgery or during an acute interventional procedure and then a triggered for stimulation by using the external system. In one embodiment of these systems, a controller-transmitter is activated by an external pacemaker to time the delivery of acoustic energy transmission through the body to a receiver-stimulator at a target tissue location. The receiver-stimulator converts the acoustic energy to electrical energy for electrical stimulation of the heart tissue.
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2. The method of claim 1, wherein receiving comprises receiving the acoustic energy at least two different cardiac stimulation sites.
3. The method of claim 2, wherein the signal information sequentially activates two receiver-stimulators to stimulate two different cardiac sites sequentially.
4. The method of claim 2, wherein the signal information simultaneously activates two receiver-stimulators to stimulate two different cardiac sites simultaneously.
5. The method of claim 1, wherein the cardiac stimulation energy is delivered to prevent an abnormal cardiac rhythm.
6. The method of claim 1, wherein the cardiac stimulation energy is delivered to terminate an abnormal cardiac rhythm.
7. The method of claim 1, wherein the cardiac stimulation energy is delivered to improve cardiac hemodynamics.
8. A system for stimulating cardiac tissue, said system comprising:
an external pacemaker and one or more temporary pacing leads having an electrode assembly adapted to be in direct contact with cardiac tissue wherein the external pacemaker is adapted to sense cardiac activity using the pacing leads and deliver electrical pacing pulse energy sufficient to stimulate the cardiac tissue;
an external acoustic controller-transmitter adapted to be connected to one or more of the pacing leads and to detect pacing level electrical signals on the pacing lead s; and
an implantable acoustic receiver-stimulator having an electrode assembly adapted to be in direct contact with cardiac tissue, wherein the controller-transmitter and receiver-stimulator are adapted to transmit and receive acoustic energy which provides both energy and signal information to the receiver-stimulator sufficient to stimulate said cardiac tissue.
View Dependent Claims (9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42)
9. The system of claim 8, wherein the receiver-stimulator comprises an acoustic receiver which receives acoustic energy and generates alternating current, means for converting the alternating current to a direct current or waveform to stimulate the cardiac tissue, and electrodes adapted to deliver the direct current or waveform to myocardial tissue.
10. The system of claim 9, wherein the implantable receiver-stimulator and temporary pacing leads are adapted to be placed and secured within a cardiac chamber.
11. The system of claim 9, wherein the implantable receiver-stimulator and temporary pacing leads are adapted to be embedded and secured within the myocardial tissue.
12. The system of claim 9, wherein the implantable receiver-stimulator and temporary pacing leads are adapted to be placed and secured on the epicardial aspect of the heart.
13. The system of claim 9, wherein the implantable receiver-stimulator and temporary pacing leads are adapted to be placed and secured within the coronary veins or arteries of the heart.
14. The system of claim 13, wherein the implantable receiver-stimulator is placed on a stent.
15. The system of claim 13, wherein the implantable receiver-stimulator is adapted to be secured between the outside of a stent wall and the inside of a vessel wall.
16. The system of claim 8, wherein the externally applied acoustic controller-transmitter is adapted to trigger an acoustic transmission into a patient upon detecting an electrical pacing pulse signal on the pacing lead to synchronize contraction between the left and right ventricles.
17. The system of claim 8, wherein the externally applied acoustic controller-transmitter is adapted to trigger an acoustic transmission into a patient based upon detecting an electrical pacing pulse signal on the pacing lead to synchronize contraction within the left ventricle.
18. The system of claim 8, wherein the externally applied acoustic controller-transmitter is adapted to trigger an acoustic transmission into a patient based upon detecting an electrical pacing pulse signal on the pacing lead to synchronize contraction between the left and right atria.
19. The system of claim 8, wherein the externally applied acoustic controller-transmitter is adapted to trigger an acoustic transmission into a patient based upon detecting an electrical pacing pulse signal on the pacing lead to synchronize contraction between the atrium and the ventricle.
20. The system of claim 8, wherein the externally applied acoustic controller-transmitter is adapted to trigger an acoustic transmission into a patient based upon detecting an electrical pacing pulse signal on the pacing lead to synchronize contraction between multiple sites within the heart.
21. The system of claim 8, wherein the external pacemaker and the externally applied acoustic controller-transmitter are adapted to be an integrated device.
22. The system of claim 8, wherein the externally applied acoustic controller-transmitter comprises a power source, control and timing circuitry to detect an electrical pacing signal and provide a pacing trigger, means for converting the pacing trigger to an acoustic energy signal, and means for transmitting the acoustic energy signal to the receiver-stimulator.
23. The system of claim 22, wherein control and timing circuitry includes one or more means for sensing physiologic variables or non-physiologic variables in order to adjust timing of the trigger.
24. The system of claim 23, wherein sensing non-physiologic variables includes detecting a pacemaker pacing output and timing the pacing trigger for stimulation from that detection in order to synchronize the cardiac stimulation from the implantable receiver-stimulator with an external pacemaker.
25. The system of claim 23, wherein means for sensing physiologic variables includes a blood pressure sensor.
26. The system of claim 23, wherein means for sensing physiologic or non-physiologic variables includes an electrogram signal processor for processing signals from electrodes that are in contact with tissue.
27. The system of claim 26, wherein the electrogram signal processor is adapted to detect intrinsic cardiac beats.
28. The system of claim 26, wherein the electrogram signal processor is adapted to detect pacemaker pacing output.
29. The system of claim 26, wherein the electrogram signal processor is adapted to detect non-intrinsic cardiac beats initiated by pacemaker pacing outputs.
30. The system of claim 26, wherein the electrogram signal processor is adapted to detect tachyarrhythmia.
31. The system of claim 27, wherein the control circuitry can selectively pace after detecting tachyarrhythmia.
32. The system of claim 23, wherein means for sensing physiologic variables includes an accelerometer for sensing body movement.
33. The system of claim 23, wherein means for sensing physiologic variables includes a sound sensor for processing heart sounds.
34. The system of claim 23, wherein means for sensing physiologic variables includes impedance sensor to detect changes in the body related to respiration cycles or lung edema.
35. The system of claim 23, wherein means for sensing physiologic variables includes a temperature sensor.
36. The system of claim 8, further comprising at least one additional receiver-stimulator device.
37. The system of claim 36, wherein the system is programmed to activate the receiver-stimulator devices sequentially.
38. The system of claim 36, wherein the system is programmed to activate the receiver-stimulator devices simultaneously.
39. The system of claim 38, wherein the external pacemaker and the external acoustic controller-transmitter are integrated into a single device.
40. The system of claim 39, wherein the external controller-transmitter/pacemaker combination comprises a power source, control and timing circuitry to detect an electrical pacing signal and provide multiple pacing signals, means for amplifying and applying at least one conventional pacing output signal to cardiac tissue through electrodes on the temporary pacing leads, plus means for converting at least one pacing signal to an acoustic energy signal, and means for transmitting the acoustic energy signal to the receiver-stimulator.
41. The system of claim 8 further wherein the transmitter and receiver-stimulator are adapted to transmit and receive acoustic energy wherein the frequency of the acoustic energy is between 20 kHz and 10 MHz.
42. The system of claim 41, wherein the frequency of the acoustic energy is most preferably between 200 kHz and 500 kHz.
43. A method for stimulating cardiac tissue, said method comprising:
generating acoustic energy at an external site on a patient;
receiving said acoustic energy at a cardiac stimulation site, wherein said acoustic energy is converted into cardiac stimulation energy based on both energy and signal information included in the generated acoustic energy; and
using the cardiac stimulation energy stimulation for pacing.
44. The method of claim 43, wherein stimulating cardiac tissue provides left ventricular stimulation synchronously with right ventricular stimulation.
45. The method of claim 43, wherein stimulating cardiac tissue provides atrial stimulation synchronously with ventricular stimulation.
46. The method of claim 43, wherein synchronizing the cardiac tissue stimulation is performed by processing electrogram signals obtained from a surface ECG.
47. The method of claim 46, wherein the processing of electrogram signals and synchronizing the stimulation is performed by sensing atrial and/or ventricular electrogram signals.
48. The method of claim 46, wherein the processing of electrogram signals and synchronizing the stimulation is performed through a direct connection to leads in contact with the heart.
49. The method of claim 43, wherein synchronizing the stimulation is performed by detecting intrinsic or non-intrinsic cardiac beats from an electrogram signal.
50. A method for stimulating cardiac tissue, said method comprising:
placing surface ECG leads on a patient, connecting the leads to an external controller-transmitter pacemaker, implanting a receiver-stimulator at a cardiac stimulation site, detecting cardiac electrogram signals on the ECG leads, determining timing for pacemaker outputs to the heart and generating acoustic energy, applying the generated acoustic energy to an external site on the patient; and
receiving said acoustic energy at the cardiac stimulation site, wherein said acoustic energy is converted into cardiac stimulation energy based on both energy and signal information included in the generated acoustic energy.
View Dependent Claims (51, 52, 53, 54, 55, 56)
51. The method of claim 50, wherein receiving comprises receiving the energy at least two different cardiac stimulation sites.
52. The method of claim 51, wherein the signal information sequentially activates two receiver-stimulators to stimulate two different cardiac sites sequentially.
53. The method of claim 51, wherein the signal information simultaneously activates two receiver-stimulators to stimulate two different cardiac sites simultaneously.
54. The method of claim 50, wherein the cardiac stimulation energy is delivered to prevent an abnormal cardiac rhythm.
55. The method of claim 50, wherein the cardiac stimulation energy is delivered to terminate an abnormal cardiac rhythm.
56. The method of claim 50, wherein the cardiac stimulation energy is delivered to improve cardiac hemodynamics.
This application is a continuation-in-part of U.S. patent application Ser. No. 11/315,023 (Attorney Docket No. 021834-000820US), filed on Dec. 21, 2005, and claims the benefit and priority of the following: U.S. Provisional Application No. 60/689,606 (Attorney Docket No. 021834-000810US), filed on Jun. 9, 2005; U.S. Provisional Application No. 60/639,027 (Attorney Docket No. 021834-000800US), filed on Dec. 21, 2004; and U.S. Provisional Patent Application No. 60/639,037 (Attorney Docket No. 021834-000900US), filed on Dec. 21, 2004, the full disclosures of which are incorporated herein by reference.
The systems and methods of this invention relate to electrical stimulation of the heart by means of an implantable device. Specifically, the present invention relates to systems and methods for providing such stimulation without the use of conventional lead/electrode systems. More specifically, the present application provides systems and methods for treatment of heart failure and for terminating heart arrhythmias using external and implantable pacing systems and components.
For these reasons, it would be desirable to accomplish stimulation without lead wires. In this application we describe methods and apparatus, using acoustic energy in combination with an implantable leadless stimulator and an external control system that overcome limitations in pacing site selection. In co-pending applications we further describe improved stimulating devices. Methods and systems to evaluate and optimize positioning for implantation of this invention are described herein.
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The present invention provides methods and devices to electrically stimulate cardiac muscle and other body tissue utilizing acoustic energy to transmit both energy and signal information from an external device to an implanted device. The external device, generally referred to as the controller-transmitter or acoustic controller-transmitter, provides appropriate timing and control functions and transmits acoustic energy to the implanted device. The implanted device, generally referred to as the receiver-stimulator, receives the acoustic energy and converts it into electrical energy and applies that electrical energy to stimulating electrodes. The implanted device is adapted to be permanently implanted at a location where it is desired to provide electrical stimulus, with the stimulating electrodes in direct contact with the cardiac muscle or other body tissue. Optionally, two or more receiver-stimulators may be implanted to be controlled by a controller-transmitter.
A cardiac pacemaker employing ultrasonic energy transfer according to the present invention comprises an implantable receiver-stimulator device adapted to be implanted in or attached to any desired location either endocardially, epicardially, or intramyocardially. Various surgical or minimally invasive, transvascular techniques and tools (e.g., injectors, catheters, stylets) can be adapted and used to deliver, place, embed, and secure the receiver-stimulator device to these locations. The receiver-stimulator would additionally be adapted to provide permanent attachment to the implant site including possibly the use of helical coils, barbs, tines, clips, or the like. Design features such as tines or irregularities in surface, or by bonding onto its outer surface materials, which are known to stimulate cellular growth and adhesion, would enhance chronic endothelialization. Alternatively, the receiver-stimulator could be adapted for implantation in the coronary vasculature at preferred sites for stimulation, e.g., incorporated into a stent-like platform suitable for intravascular delivery and deployment. In a specific embodiment, the device could reside on the outer surface of a stent and be held in place between the outer stent wall and the inner vessel wall. Functionally, the receiver-stimulator device comprises 1) an ultrasound transducer to receive the acoustic energy from a controller-transmitter device and transform it into electrical energy, 2) an electrical circuit to transform the alternating electrical energy into a direct current or waveform having other characteristics, and 3) electrodes to transfer electrical energy to the myocardium. The receiver-stimulator would use signal information from the acoustic energy transmission to configure the electrical output, for example, the pulse width of the transmission would determine the pulse duration/width of the electrical output waveform. Additionally, the receiver-stimulator may comprise circuitry for additional control logic, for example, selecting activation of individual receiver-stimulators (on-off control), timing delays, waveform shape adjustments, or the like. In particular, when more than one receiver-stimulator is implanted to be controlled by a single controller-transmitter, the transmitted energy signal may contain addressing or selection information identifying which receiver-stimulator is to be activated at any particular time.
Subsequently, an external controller-transmitter device would be used; this device containing some or most or all the elements of currently available external pacemaker systems, with specific adaptations pertinent to this invention. Such typical pacemaker elements may include a power source, pacemaker control and timing circuitry, a sensing system possibly comprised of cardiac electrogram sensing electronics, motion detectors, body or other temperature sensors, pressure sensors, impedance sensors (e.g., for measuring respiration cycles or lung edema), or other types of physiologic sensors, and signal conditioning and analysis functions for the various electrodes and detectors. Additionally, the controller-transmitter device would contain an ultrasound amplifier and an ultrasound transducer to generate acoustic energy, and transmit such energy from the surface of the body in the general direction of the heart and specifically in the direction of the implanted receiver-stimulator device. The duration, timing, and power of the acoustic energy transmission would be controlled as required, in response to detected natural or induced physiological events or conditions, and per known electrophysiological parameters, by the pacemaker control electronics.
In a first preferred embodiment a leadless cardiac pacemaker would be employed as a left ventricular stimulator functioning with an external controller-transmitter that is a “slave” to an external conventional (i.e., utilizing wires/electrodes) right heart pacemaker, either a single or preferably a dual chamber type. The purpose of such a slave controller-transmitter system would be to provide left ventricular pacing alone or provide left ventricular pacing synchronous with the right ventricular pacing provided by the external right heart pacemaker as a beneficial treatment for cardiac surgery patients to improve hemodynamics, but without necessitating the placement of a left ventricular lead/wire.
In such an embodiment, the receiver-stimulator would be implanted at a desired location within or on the left ventricle, preferably fully attached within the myocardium. A specialized controller-transmitter would then be externally configured with a transmitter placed at a location on the skin that allows acoustic energy transfer to the implanted receiver-stimulator (i.e., an acoustic window). The specialized “slave” controller-transmitter would connect directly to a pacing output port of the external pacemaker or would connect to a T-junction with the ventricular lead/wire connected to the external pacemaker. The slave controller-transmitter would include circuitry to detect pacing output signals from the external right heart pacemaker. The slave controller-transmitter would then respond to the pacing output signal and transmit acoustic energy to the implanted receiver-stimulator in order to produce a left ventricular stimulation at the desired time in relation to timing directed by the external pacemaker for intended ventricular paced output. For example, if the connection from the external pacemaker to a ventricular output channel is directly connected to and monitored by the slave controller-transmitter, then with each detected pacing output, a transmission occurs immediately upon this detection, a left ventricular pacing stimulus is delivered by the receiver-stimulator to the left ventricle. Further, if the ventricular output channel of the external pacemaker is connected to a right ventricular lead and the slave controller-transmitter is monitoring the output on the lead, then the transmission will be nearly simultaneous with the RV pacing output to the lead and will produce bi-ventricular pacing therapy. In this configuration, the external pacemaker would be able to use the right ventricular lead connection for sensing cardiac events using the electrodes of the lead.
The methods and systems of the present invention may be utilized for antitachycardia pacing (ATP), including prevention algorithms, utilizing acoustic energy to transmit energy and signal information from a controller-transmitter, which is externally located, to one or more implanted receiver-stimulators having electrodes adapted to be implanted in direct contact with cardiac tissue. The acoustic controller-transmitter will usually have ECG or other monitoring means that allow detection of tachycardia.
FIG. 2 illustrates an external pacemaker combining the functions of a pacemaker and the function of a controller-transmitter with multiple implanted receiver-stimulators in accordance with the principles of the present invention.
The systems and devices described comprise a controller-transmitter device that will deliver acoustic energy and information to one or more implanted receiver-stimulator device(s) that will convert the acoustic energy to electrical energy of a form that can be used to electrically pace the heart. The acoustic energy can be applied with ultrasound as a single burst or as multiple bursts with appropriate selection of the following parameters:<tables id="TABLE-US-00001" num="1"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="3"><colspec colname="OFFSET" colwidth="28PT" align="left"/><colspec colname="1" colwidth="105PT" align="left"/><colspec colname="2" colwidth="84PT" align="left"/><thead><row><entry/><entry/></row><row><entry/><entry namest="OFFSET" nameend="2" align="center" rowsep="1"/></row><row><entry/><entry>Parameter</entry><entry>Value Range</entry></row><row><entry/><entry namest="OFFSET" nameend="2" align="center" rowsep="1"/></row></thead><tbody valign="top"><row><entry/><entry>Ultrasound frequency</entry><entry>20 kHz-10 MHz</entry></row><row><entry/><entry>Burst Length (#cycles)</entry><entry>2-10,000</entry></row><row><entry/><entry>Stimulation Pulse Duration</entry><entry>0.1 μS-10 mS</entry></row><row><entry/><entry>Duty Cycle</entry><entry>0.01-0.2%</entry></row><row><entry/><entry>Mechanical Index</entry><entry>≦1.9</entry></row><row><entry/><entry namest="OFFSET" nameend="2" align="center" rowsep="1"/></row></tbody></tgroup></table></tables>
Examples of external leadless cardiac pacemaker systems are illustrated in FIGS. 1 through 2.
FIG. 1 illustrates a “slave” configuration in a biventricular pacing application in conjunction with a conventional external dual chamber pacemaker. It should be appreciated that this slave configuration is equally applicable to single chamber, dual chamber, or ATP pacing applications that would be supported by an external pacemaker in many combinations of leads/wires and receiver-stimulators contacting heart tissue. In FIG. 1, an external dual chamber pacemaker device 1 containing circuitry to provide pacing and sensing control is connected to leads 3 and 4 which are shown inserted into the right atrium and the right ventricle respectively through an access into the patient and placed through vascular means into the heart. The right ventricular lead 4 is connected through a T-junction component 5 and a cable 6 is connected to a controller-transmitter 7. Upon detection of a pacing level output signal on cable 6, an ultrasound signal is transmitted onto the surface of the patient by the controller-transmitter 7 via transmit transducer 8 through intervening tissue to the receiver-stimulator device 2, shown implanted in the left ventricle. Receiver-stimulator device 2 contains means to receive this acoustic energy and convert it into an electrical pulse which may then be applied to the attached electrodes. In this example the conventional external dual chamber pacemaker 1 utilizing both a conventional right atrial lead/wire 3 and conventional right ventricular lead/wire 4 is used to deliver pacing modalities to the right heart with the controller-transmitter 7 incorporating connections and appropriate control circuitry that allows detection of the pacing pulse output form the external pacemaker 1 and provides information whereby the control circuitry can at the proper time initiate the acoustic transmission which will result in left ventricular pacing. In this example, bi-ventricular pacing is achieved.
Modifications to the configuration of FIG. 1 can be made for many combinations utilizing an external pacemaker driving a slave controller-transmitter based detection of the pacing pulse output from the master external pacemaker
FIG. 2 illustrates a stand alone configuration in a dual chamber pacing application using an external noninvasive dual chamber pacemaker. It should be appreciated that this standalone noninvasive configuration is equally applicable to single chamber, dual chamber, multi-site, or ATP pacing applications that would be supported by an external pacemaker in many combinations with receiver-stimulators contacting heart tissue. In FIG. 2 an external dual chamber pacemaker device 21 containing circuitry to provide pacing and sensing control and circuitry to generate acoustic transmission is connected to multiple surface ECG leads c, which are shown in the left arm, right arm, and right leg placement. It should be appreciated that any number of appropriate ECG leads may be utilized. Compared to the external pulse generator 1 (shown in FIG. 1), external acoustic pulse generator 21 is an integrated device with the ability to sense cardiac electrograms and generate acoustic pacing signal. The ECG leads 23 are connected to the pacemaker device 21 to provide the capability in the pacemaker device for processing a surface ECG signal and using information from the signal to provide pacing mode therapy. Based on selected setting on the control panel of the pacemaker device 21 pacing is applied by an ultrasound signal transmission onto the surface of the patient by the pacemaker device 21 via transmitter transducer 24 through intervening tissue to the receiver-stimulator devices 22, shown implanted in the right atrium and the left ventricle. Receiver-stimulator devices 22 contain means to receive this acoustic energy and convert it into an electrical pulse which may then be applied to the attached electrodes. Compared to the receiver-stimulator 2 (shown in FIG. 1), receiver-stimulator devices 22 are capable of being activated individually. The pacemaker device 21 and/or the receiver-stimulator devices 22 are adapted to trigger pacing simultaneously, synchronously, or independently. In this example, the external dual chamber pacemaker device 21 is configured to provide dual chamber pacing to the right atrium and the left ventricle.
Modifications to the configuration of FIG. 2 can be made for many combinations utilizing an external pacemaker transmitting ultrasound to one or more receiver-stimulators and utilizing sensing components to adjust pacing modalities.
Brisken, Axel, Echt, Debra, Riley, Richard, COWAN, MARK
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