The present invention relates to medical devices and methods. More specifically, the present invention relates to devices and methods associated with sensing and causing cardiac function.
Congestive heart failure (CHF) or a myocardial infarction can result in heart tissue that is incapable of contributing to the pumping action of the heart. Where heart tissue damage is severe from the CHF or myocardial infarction, the affected heart tissue will even be non-responsive to pacing therapy provided via an implanted pulse generator such as, for example, a pacemaker or implantable cardioverter defibrillator (ICD).
Pacing and defibrillation therapies provided via an implantable pulse generator require the sensing of the natural cardiac electrical signals and the pulse generator administered electrical signals. For example, implantable medical leads extend from the pulse generator implanted in the patient's upper chest to locations within the patient's heart, for example, the right ventricle, right atrium and coronary sinus. The distal region of each lead includes electrodes for pacing and/or defibrillation. Also, the distal region of each lead further includes electrodes for sensing the natural cardiac and administered electrical signals. The pulse generator analyzes these sensed electrical signals to determine the how to administer the electrotherapy via the pacing and/or defibrillation electrodes.
Unfortunately, the sensing electrodes may sense electrical noise and far-field signals, which can mislead the analysis by the pulse generator. As a result, the pulse generator can administer inappropriate electrotherapy to the patient's heart, potentially leading to life threatening cardiac conditions.
There is a need in the art for systems, devices and methods for addressing the above-mentioned shortcomings.
Disclosed herein is a system for monitoring a motion of a cardiac tissue. In a first embodiment, the system includes a motion sensor configured to operably couple to the cardiac tissue. The motion sensor includes an electroactive polymer and is further configured to result in a deflection in the electroactive polymer when the cardiac tissue undergoes the motion. The deflection in the electroactive polymer generates an electrical event. The electrical event may include an electrical potential.
In a first version of the first embodiment of the system, the system may further include an implantable medical lead on which the motion sensor is supported, the lead being at least partially responsible for the motion sensor being operably coupled to the cardiac tissue. The lead may include a distal helical anchor configured to actively attach to the cardiac tissue, the anchor being at least partially responsible for the motion sensor being operably coupled to the cardiac tissue. The first version of the first embodiment of the system may yet further include a device electrically coupled to the motion sensor via the lead, the device configured to detect the electrical event and determine a characteristic of the cardiac motion from the electrical event. The characteristic may include heart rate, contractility, contractile velocity, or heart chamber contractile timing (i.e., A to V or V to V timing). The device may include an implantable pulse generator.
In a second version of the first embodiment of the system, the system may further include a substrate on which the motion sensor is supported, the substrate being at least partially responsible for the motion sensor being operably coupled to the cardiac tissue. The substrate may include a surface patch configured to be applied to the cardiac tissue. The surface patch may include at least one of an adhesive configured for cardiac tissue adherence or a mesh configured for cardiac tissue ingrowth. Alternatively or additionally, the surface patch may be at least one of configured to suture or staple to the cardiac tissue. The surface patch may have a shape that is generally rectangular, circular or cross-shaped. The second version of the first embodiment of the system may further include a lead and a device electrically coupled to the motion sensor via the lead, the device configured to detect the electrical event and determine a characteristic of the cardiac motion from the electrical event. The characteristic may include heart rate, contractility, contractile velocity, or heart chamber contractile timing (i.e., A to V or V to V timing). The device may include an implantable pulse generator.
In a third version of the first embodiment of the system, the system may further include a motion causing assembly configured to operably couple to the cardiac tissue and including an electroactive polymer that deflects upon being subjected to an electrical potential. The deflection of the electroactive polymer results in deflection of the motion causing assembly, thereby causing motion in the cardiac tissue operably coupled to the motion causing assembly. Thus, in some instances, the motion causing assembly may be considered a cardiac compression device, which when actuated, results in the compression of the region of the heart to which the motion causing assembly is operably coupled. The motion causing assembly may include a substrate on which the motion causing assembly is supported, the substrate being at least partially responsible for the motion causing assembly being operably coupled to the cardiac tissue. The substrate may include a surface patch configured to be applied to the cardiac tissue. The surface patch may include at least one of an adhesive configured for cardiac tissue adherence or a mesh configured for cardiac tissue ingrowth. Alternatively or additionally, the surface patch may be at least one of configured to suture or staple to the cardiac tissue. The third version of the first embodiment of the system may further include a lead and a device electrically coupled to the motion causing assembly via the lead, the device configured to generate the electrical potential. The device may include an implantable pulse generator.
Also disclosed herein is a method of monitoring a motion of a cardiac tissue. In a first embodiment, the method includes: operably coupling a motion sensor to the cardiac tissue in such a manner that motion of the cardiac tissue deflects an electroactive polymer of the motion sensor; and detecting an electrical event generated by deflection of the electroactive polymer. The electrical event may include an electrical potential. The first embodiment of the method may further include analyzing the detected electrical event to determine a characteristic of the cardiac motion from the electrical event. The characteristic may include heart rate, contractility, contractile velocity, or heart chamber contractile timing (i.e., A to V or V to V timing). The first embodiment of the method may additionally or alternatively include: operably coupling a motion causing assembly to the cardiac tissue; and subjecting an electroactive polymer of the motion causing assembly to an electrical potential, the deflection of the electroactive polymer resulting in deflection of the motion causing assembly, thereby causing motion in the cardiac tissue operably coupled to the motion causing assembly.
While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. As will be realized, the invention is capable of modifications in various aspects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.
Disclosed herein are medical devices employing electroactive polymer (EAP) to sense cardiac motion and/or cause cardiac compression. In one embodiment, an EAP equipped device can be coupled to heart tissue such that heart contractions will cause the EAP to flex, resulting in the generation of an electrical potential or charge that can be sensed and analyzed to determine cardiac operational characteristics such as, for example, heart rate and contractility. These cardiac operational characteristics can then be used to identify cardiac conditions such as, for example, ventricular tachycardia or ventricular fibrillation.
In another embodiment, an EAP equipped device can be coupled to heart tissue such that an electrical signal delivered to the EAP will cause the EAP equipped device to compress the heart tissue, causing a cardiac compression. Where such an EAP equipped device is coupled to heart tissue encompassing a myocardial infarction, the region of the myocardial infarction may be caused to contribute in the cardiac compression where traditional pacing-only therapies would fail to do so.
For a discussion of one embodiment of an EAP equipped device configured to sense cardiac motion, reference is made to
A lead may be configured for passive fixation in the heart 12. In one embodiment, a distal region of a lead may be configured for passive fixation such as, for example, the lead body being configured to bias against the walls of the coronary sinus to passively maintain the lead in place. In one embodiment, the distal tip of a lead may be configured for passive fixation such as, for example, the lead distal tip having pliable tines radiating from the lead distal tip. In embodiments where the lead is configured for passive fixation, the tip electrode 22, 26, 32 may be in the form of a ring or semi-spherical dome.
The lead may be configured for active fixation. In one embodiment, a distal tip of a lead may be configured for active fixation, wherein the tip electrode 22, 26, 32 is in the form of a helical anchor electrode that allows the electrode to be screwed into cardiac tissue.
A proximal end of each lead 20, 24, 30 is coupled to the pulse generator 10 and the leads extend distally into the heart 12. For example, one lead 20 may extend from the pulse generator into the right atrium 40 where the lead tip electrode 22 is passively or actively fixed to a wall of the right atrium. Another lead 24 may extend from the pulse generator, through the right atrium, the coronary sinus ostium (OS) 42, and the coronary sinus 44, and into the left coronary vein 46. Yet another lead 30 may extend form the pulse generator, through the right atrium and tricuspid annulus 47 and into the right ventricle 48, the tip electrode 32 passively or actively fixed to the wall of the right ventricle near the right ventricular apex 50.
As indicated in
Depending on the embodiment, an EAP equipped lead will have any one or more of the different types of the above-mentioned electrodes/coils and the EAP equipped lead will have one or more EAP sensors located on the lead body at any one or more locations that are generally likely to undergo the most deflection once the lead is implanted. An EAP sensor can be located at a variety of locations on an EAP equipped lead, and the examples discussed above are purely for illustrative purposes and not intended to limit the possibilities with respect to EAP sensor number or placement on a lead body. An EAP equipped lead with any of the electrode configurations discussed above may be employed with a variety of standard (i.e., non-EAP equipped) pacing leads in a variety of commonly employed lead placement strategies.
In some embodiments, an EAP equipped lead will have none of the above listed electrodes and will simply be a structure on which one or more EAP sensors may be mounted. Such an EAP sensor only type lead may be employed with a variety of standard (i.e., non-EAP equipped) pacing leads in a variety of commonly employed lead placement strategies.
For a discussion of some example embodiments for lead based EAP sensors 60 that can be employed on lead bodies as discussed above with respect to
As shown in
For a discussion of another embodiment of an EAP equipped device configured to sense cardiac motion, reference is made to
The devices 70 and leads 78 can be delivered minimally invasively via a subxyphoid access and punctures 80 in the pericardial sac 76. Each device 70 can be secured to the heart outer surface 72 via a variety of methods including, for example, adhesive, suture, screwed-in anchors, configurations that facilitate the device 70 being wedged into place to mechanically, forceably hold the device in place, and inflammatory response for causing tissue in-growth of cardiac tissue cells into a polyester mesh forming part of the device 70.
In some embodiments, the devices 70 are implanted on the outer surface of the pericardial sac 76. In some embodiments, the devices 70 include electrodes mounted thereon for providing pacing and/or defibrillation shocking.
As indicated in
For a discussion of some example embodiments for EAP sensors 70 that are configured for mounting on a heart outer surface 72 as discussed above with respect to
As shown in
As shown in
For each of the embodiments depicted in
For a discussion of an EAP sensor configuration 90 that may be employed as part of any of the EAP sensors 60, 70 discussed above with respect to
Current methods for IPMC manufacture rely on noble metals such as platinum and gold. Nafion® and Flemion® are common base polymers. The permselective properties of ionomeric resins allow selective reduction of metal salts at the surface of ion exchange membranes making polymer-metal composites that are not prone to delamination.
As indicated in
In one embodiment, an EAP sensor as described above with respect to
The wiring diagram 92 depicted in
The EAP sensors disclosed herein detect cardiac motion, which is used to determine heart rate, contractility, etc. Thus, unlike the sensing electrodes of leads, which relying on the sensing of electrical signals, the EAP sensors are less susceptible to electrical noise and far-field signal contributions than conventional electrical sensing.
For a discussion of one embodiment of an EAP equipped device configured to cause cardiac compression, reference is made to
As can be understood from
Alternatively, the device 122 may be in the form of a patch or sheet that extends over a selected portion of the heart surface, but does not encompass or extend about the heart. For example, the sheet 122 may be secured over a region of the heart having an infarction, which benefits from both the reinforcement of the sheet 122 and the compression of the sheet as a pacing signal is delivered to the EAP imbedded in the sheet 122.
In some embodiments, EAP sensors on leads (as discussed with respect to
Although the present invention has been described with reference to preferred embodiments, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.