Atrial Appendage Occlusion and Arrhythmia Treatment
Atrial appendage occlusion devices and arrhythmia treatment.
This application claims priority to U.S. Provisional Patent Application No. 61/441,627, filed Feb. 10, 2011, the entire disclosure of which is incorporated by reference herein.
INCORPORATION BY REFERENCEAll publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
BACKGROUND OF THE DISCLOSUREAtrial fibrillation (“AF”) is an arrhythmia of the heart that results in a rapid and chaotic heartbeat, producing lower cardiac output and irregular and turbulent blood flow in the vascular system. The left atrial appendage (“LAA”) is a cavity extending from the lateral wall of the left atrium between the mitral valve and the root of the left pulmonary veins. The LAA normally contracts with the rest of the left atrium during a normal heart cycle, keeping blood from becoming stagnant therein, but often fails to contract with any vigor in patients experiencing AF due to the discoordinate electrical signals associated with AF. The result is that blood tends to pool in the LAA, which can lead to the formation of blood clots therein. The blood clots can then propagate out from the LAA into the left atrium. Since blood from the left atrium and ventricle supply the heart and brain, blood clots from the LAA can obstruct blood flow thereto, causing heart attacks, strokes, or other organ ischemia. Blood clots form in the LAA in about 90% of patients with atrial thrombus. Patients with AF account for one of every six stroke patients, and thromboemboli originating from the LAA are the suspected culprit in the vast majority of these cases. More than 3 million Americans have AF, which increases their risk of stroke by a factor of 5. Elimination or containment of thrombus formed within the LAA of patients with AF will significantly reduce the incidence of stroke in those patients.
Administering an anticoagulant such as warfarin is the most commonly prescribed treatment for stroke prevention in patients with AF. The effectiveness of warfarin, however, is challenged due to serious side effects, lack of patient compliance in taking the medication, a narrow therapeutic window, and an increased risk of bleeding.
LAA occlusion can be used as an alternative for patients who cannot use oral anticoagulants such as warfarin. Approximately 17% of patients cannot take anticoagulants because of a recent or previous bleeding, non-compliance, or pregnancy. Current US FDA-approved occlusion methods staple the LAA closed or suture and excise the appendage. Studies, however, have shown these techniques produce inconsistent results. Some new approaches, currently under FDA investigation, deliver an implant from within the vascular system.
Devices are needed, however, to more consistently and effectively prevent clots from entering the atrium from the appendage. While blocking the appendage from the atrium can prevent thrombus from entering the atrium, an approach that can also provide therapy for the arrhythmia will reduce the risk of stroke while treating the arrhythmia.
SUMMARY OF THE DISCLOSUREOne aspect of the disclosure is an implantable cardiac orifice occlusion and arrhythmia treatment device, comprising: an anchoring portion adapted to anchor the device in place adjacent a cardiac orifice; a barrier element secured to the anchoring portion and adapted to cover the orifice when implanted, and adapted to prevent blood clots from passing through the barrier element; and an arrhythmia treatment element secured to at least one of the anchoring portion and the barrier element, the treatment element adapted to treat a detected cardiac arrhythmia.
In some embodiment the device further includes an electrical activity monitoring element adapted to monitor electrical activity of the heart indicative of the arrhythmia. The monitoring element can be adapted to be disposed in contact with atrial tissue to monitor electrical activity of the heart. The monitoring element can be adapted to be disposed in contact with atrial appendage tissue to monitor electrical activity of the heart. The monitoring element can include an arrhythmia detection component adapted to detect when the arrhythmia is occurring. The treatment element can be adapted to treat the arrhythmia when the arrhythmia is detected by the detection component. The monitoring element can include an arrhythmia detection component adapted to detect when atrial fibrillation is occurring. The anchoring portion, the barrier element, the monitoring element, and the treatment element can be integrated into a singular implantable device. The device can also include a detector adapted to detect when the arrhythmia is occurring, the detector being disposed external to the patient, wherein the monitor is adapted to transmit data indicative of the electrical activity of the heart to the detector.
In some embodiments the treatment element is adapted to pace cardiac tissue to treat the detected arrhythmia.
In some embodiments the treatment element is adapted to deliver a therapeutic agent to cardiac tissue to treat the detected arrhythmia.
In some embodiments the anchoring portion, the barrier element, and the treatment element are integrated into a singular implantable device.
In some embodiments the anchoring portion includes a distal deformable anchoring portion and a proximal deformable anchoring portion, the distal anchoring portion adapted to be deployed in a left atrial appendage and anchored to left atrial appendage tissue, wherein the proximal anchoring portion is adapted to be deployed in a left atrium and anchored to left atrial tissue.
One aspect of the disclosure is a method of cardiac orifice blocking and arrhythmia treatment, comprising: an integrated implantable device comprising an anchoring portion, a barrier element, a monitor, and a treatment element; anchoring the anchoring portion against cardiac tissue near a cardiac orifice to block the flow of clots through the orifice with the barrier; positioning the monitor to be in contact with cardiac tissue to monitor cardiac activity indicative of an arrhythmia; and providing for the treatment of the arrhythmia with the treatment element.
In some embodiments the positioning step comprises positioning the monitoring component against atrial tissue.
In some embodiments the positioning step comprises positioning the monitoring component against atrial appendage tissue.
In some embodiments the anchoring step comprises allowing the anchoring portion to deform from a delivery configuration towards a deployed configuration in which it anchors against cardiac tissue.
One aspect of the disclosure is a cardiac orifice blocking device, comprising: an anchoring portion comprising a proximal anchoring portion and a distal anchoring portion, the proximal anchoring portion adapted to be anchored against left atrial tissue, and the distal anchoring portion adapted to be anchored against left atrial appendage tissue; a hub secured to the proximal and distal anchoring portions; a barrier portion comprising a proximal barrier secured to the proximal anchoring portion, the proximal barrier adapted to prevent blood clots from passing therethrough, and a distal barrier portion secured to the distal anchoring portion.
In some embodiments the proximal anchoring portion has a greater radial dimension in a deployed configuration that a radial dimension of the distal anchoring portion in a deployed configuration.
In some embodiments the proximal anchoring portion comprises a plurality of deformable anchoring elements that extend substantially radially outward from the hub in their deployed configurations.
In some embodiments the proximal anchoring portion comprises a plurality of deformable anchoring elements, each of the plurality of anchoring elements having a loop configuration. The plurality of anchoring elements can be in the same plane in a side view of the device, and it can be substantially orthogonal to a longitudinal axis of the hub. The distal anchoring portion can include a plurality of deformable anchoring elements that extend substantially radially outward from the hub in their deployed configurations. The distal anchoring portion can include a plurality of deformable anchoring elements, each of the plurality of anchoring elements having a loop configuration. The plurality of anchoring elements can be in the same plane in a side view of the device, which can be substantially orthogonal to a longitudinal axis of the hub.
In some embodiments the proximal barrier is secured proximal to the proximal anchoring portion.
In some embodiments the distal barrier is secured proximal to the distal anchoring portion.
In some embodiments the proximal barrier comprises at least one pleat in the barrier material.
In some embodiments the proximal barrier has a substantially circular configuration.
In some embodiments the distal barrier has a substantially circular configuration.
In some embodiments the proximal anchoring portion comprises a plurality of deformable proximal anchoring elements that extend substantially radially outward from the hub in their deployed configurations, and the distal anchoring portion comprises a plurality of deformable distal anchoring elements that extend substantially radially outward from the hub in their deployed configurations, wherein the proximal anchoring elements extend further radially outward than the distal anchoring elements.
In some embodiments the distal anchoring portion and the proximal anchoring portion are formed integrally with the hub.
In some embodiments the proximal barrier has a greater radial dimension than the distal barrier when the distal and proximal anchoring portions are in their respective deployed configurations.
Exemplary patentable features of the disclosure are set forth in the claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which:
The disclosure herein relates to isolating clots to prevent them from entering into an atrium of the heart. While the disclosure focuses on the left atrial appendage (“LAA”) and the left atrium, the systems can be used in the right atrial appendage and the right atrium. The devices may also be used to close other undesirable orifices in the heart, such as Atrial Septal Defects (“ASD”) or Patent Foramen Ovales (“PFO”). They may also be used in other portions of a body unrelated to the heart. The disclosure herein also relates to providing therapy for a detected cardiac arrhythmia to attempt to prevent the formation of clots within the appendage.
One aspect of the disclosure herein relates to LAA occlusion devices and methods of use. A second aspect of the disclosure herein provides for intra-atrial or intra-LAA cardiac monitoring and therapy for a detected arrhythmia.
The first aspect can be a stand-alone procedure to occlude the LAA from the left atrium. The second aspect can similarly be a stand-alone procedure to monitor and provide therapy. Alternatively, the occlusion device can be integrated with the therapy aspect. When combined, the occlusion device can be separate and distinct from the monitoring and therapy components, or they can be combined into an integrated device.
Barrier 18 acts as a primary barrier preventing blood from flowing into the LAA from the LA. Barrier 18 can be any suitable material to prevent blood flow into the LAA, such as, for example, expanded PTFE, PTFE, woven polyester fabric, biocompatible materials, polyurethane membrane, etc. In
In alternative embodiments barrier 18 acts as a filter, allowing some blood components to flow into and out of the LAA but preventing clots from flowing from the LAA into the LA. That is, barrier 18 can have a porosity to allow some blood components to flow therethrough while preventing clots (or other non-clot blood components) from passing therethrough. In some embodiments the pores can be from, for example, about 60 microns to about 150 microns in diameter. These pores sizes are not intended to be limiting.
The anchoring element is adapted to anchor implant 10 in place within the LAA. Anchoring element 16 is shown as a generally annularly-shaped component, but can have a variety of shapes. Anchor 16 provides the expansion force needed to anchor implant 10 in place. The anchor can be made from a shape memory material such as nitinol, allowing it to be deformed into a delivery configuration to deliver it to the target location. Upon release from a delivery sheath or catheter, the anchor reverts to its memory configuration. The memory configuration can be adapted to secure the anchor in place based on the outwardly directed force from the anchor against the tissue. In some embodiments the radial expansion force is applied by constructing the device from a shape memory material such as, for example, nickel-titanium (nitinol).
In any of the embodiments above, the proximal anchor (closer to the atrium) can be thin and have a fabric covering on most of the anchor but not the entire anchor. The uncovered portion of the anchor allows for cardiac monitoring and and/or pacing as described herein. The inner, or distal, disk can be mostly covered by a fabric.
Leaflets 202 each comprise a frame element 201 and a barrier 203. Leaflets 204 are similarly designed. Frame elements 201 have a general triangular or elliptical shape, and each has two ends secured to hub 212. Frame elements 201 can be, for example, wire made from, for example, nitinol. Nitinol, or other material with shape memory and/or superelastic properties, allows the triangular wire form to be deformed for loading into a delivery system, with the wire form converting to the triangular shape upon deployment due to the shape memory and/or superelastic properties of the nitinol.
Distal portion 222 includes a distal anchor, which in this embodiment comprises a plurality of anchors 206. Anchors 206 are similar in shape to the frame elements 201 from leaflets 202 and 204. Anchors 206 can be made from a wire, and can be made from, for example, nitinol. Each anchor wire has two ends secured to hub 212, to which leaflets 202 and 204 are also secured. The components can be secured to hub 212 with any suitable technique, such as bonding, welding, etc. Anchors 206 are adapted to expand and anchor in the LAA to secure the implant in place. Any of the distal anchors described herein can be used as the distal portion of implant 200. Also, while three anchors 206 are shown, any suitable number of anchors can be incorporated into implant 200. Additionally, shapes other than the generally triangular shape can be used. For example, anchors 206 can have four sides rather than three.
Leaflets 202 and 204, and anchors 206 are adapted to be collapsed down into delivery configurations such that they can be delivered endoluminally to a target location within the heart. In one exemplary embodiment, the radially outer portions of leaflets 202 are adapted to collapse downward and in the proximal direction towards one another such that the leaflets are adapted to be disposed within a delivery catheter, sheath, or other delivery instrument. The leaflets can be secured to hub such that as they collapse they overlap one another into a staggered orientation, easing their collapse. A central portion of frame elements 201 of each of the leaflets can additionally be adapted to bend outward to ease in the collapse of frame 201 (shown in phantom on one leaflet in
In any of the embodiments herein, the leaflet barrier material can be adapted to facilitate cell growth over and within the material. That is, after implantation, cells with grow over and within the barrier material, further isolating the LAA from the left atrium. In some of the embodiments, for example in
In some embodiments the bulb includes cardiac monitoring and/or pacing capabilities described in more detail below. For example, the bulb can have sensing and/or stimulating electrodes incorporated therein or on the surface adapted to be in contact with LAA tissue. For example, bulb 406 can optionally include ring electrode 416 on the surface to be in contact with LAA tissue.
In an alternative embodiment to that shown in
In some embodiments, once the anchors are secured around the LAA ostium and any other anchors are secured within the LAA, a procedure to verify the LAA is sealed from the left atrium can be performed. For example, in the embodiment shown in
In some embodiments, once a barrier is established between the left atrium and the LAA, a casting is injected through the distal port of the implant into the LAA. For example, the casting can be an electrically conductive casting or a soft polymer casting. In one particular example, ethylene vinyl alcohol (“EVOH”) is injected with a conductive filler or a conductive polymer. The delivery catheter remains in place until the casting material has solidified and it cannot enter into the bloodstream.
As an alternative to a casting material, in some embodiments a sclerosant material is injected through the implant into the LAA. The sclerosant causes the LAA to shrink. The delivery catheter remains in place until the sclerosant is no longer active and cannot get into the blood stream.
The systems herein can also include a cardiac monitoring component to monitor one or more patient parameters. In some embodiments the systems includes a monitoring component adapted to monitor electrical activity of the heart over time. The electrical activity of the heart can be monitored to detect arrhythmias, such as atrial fibrillation. In some embodiments the systems herein are adapted to provide a therapy to treat the detected arrhythmia. For example, if an arrhythmia is detected, the system can be adapted to pace cardiac tissue through electrical stimulation thereof. Alternatively, or in addition to, the systems can be adapted to deliver a therapeutic compound to the patient in the event an arrhythmia is detected. The monitoring and/or therapy components of the systems can optionally be a stand-alone device and not integrated into a LAA occlusion device.
In some embodiments the system includes a monitoring component that monitors, or senses, cardiac electrical activity. The sensing components can be positioned within the LAA and/or the left atrium, and are adapted to be in contact with cardiac tissue to sense the electrical activity. The system can monitor ECG data from the patient. In some embodiments the sensing component is an electrode or an array of electrodes in contact with cardiac tissue to monitor electrical activity of the heart.
The system is adapted to process the electrical activity data and detect atrial fibrillation from the monitored data. For example, the system can monitor ECG data and detect AF by, for example, the absence of P waves, with unorganized electrical activity in their place. Irregular R-R intervals due to irregular conduction of impulses to the ventricles can also be an indication of atrial fibrillation. The system can include software adapted to automatically detect the occurrence of AF. The system can also be adapted such that electrical activity data is transmitted to health care professionals whose interpretation of the electrical activity data can supplement or replace the automated detection process.
The detection component can be integrated with the monitoring components such that it is within the heart. Alternatively the processing component can be disposed outside the heart, and optionally external to the patient. If outside the heart, the processing component can be secured to, for example, the epicardium, or it could be a device that is worn by the patient close to the heart and that is in wireless communication with the intra-cardiac device.
In some embodiments the processing components are disposed within the heart and part of the monitoring device. The intra-cardiac system can then monitor and detect atrial fibrillation from a device implanted completely within the LAA and/or the left atrium.
In some embodiments the processing components of the system are disposed in a device external to the heart such that monitored patient data is transmitted, wirelessly or wired, to the processing component. If AF is detected therapy will likely be administered as soon as possible, and thus the monitoring component substantially continuously transmits data to the processing component such that substantially real-time detection of AF occurs.
If AF is detected, the system can be adapted to administer therapy to restore normal electrical activity to the heart. In some embodiments the therapy is electrical pacing therapy administered by, for example, pacing electrodes disposed within the LAA and/or left atrium. Electrical impulses can be delivered by electrodes that contact the cardiac muscle to pace the appendage or atrium for a short-term period of time to treat, for example, AF, atrial tachycardia, sick sinus rhythm, etc. In some embodiments pacing occurs at regular intervals. For example, pacing can occur for about 30 to about 90 seconds and occurs about every 6 to about every 12 hours. These numerical ranges are merely exemplary.
In some embodiments the therapy comprises delivering a therapeutic agent into the heart upon the detection of an arrhythmia. The implantable system can include a drug reservoir for delivery of one or more anti-atrial fibrillation drugs if the patient goes into AF. In some embodiments the LAA occlusion device is placed near the ostium of the LAA, while the cardiac monitor and drug reservoir are disposed on the appendage side of the implant. The cardiac monitor is adapted to release a prescribed amount of the therapeutic agent in the event AF is detected and lasts longer than a prescribed period of time. The therapeutic agent administered includes anti-arrhythmic and/or rate control and/or anticoagulation agents for AF. An example is Vernakalant, an investigational drug under regulatory review for the acute conversion of AF. Exemplary rate control agents and doses include Metoprolol (e.g., about 50 to about 100 mg), Atenolol (e.g., about 50 to about 100 mg), Propranolol (e.g., about 40 to about 80 mg), Acebutolol (e.g., about 200 mg), Carvedilol (e.g., about 6.25 mg), Diltiazem (e.g., about 180 to about 240 mg), Verapamil (e.g., about 180 to about 240 mg), and Digoxin (e.g., about 0.125 mg). Exemplary rhythm control agents and doses include Propafenone (e.g., about 450 mg), Flecainide (e.g., about 200 mg), Sotalol (e.g., about 240 mg), Dofetilide (e.g., about 500 mcg), Amiodarone (e.g., about 200 mg), Quinidine (e.g., about 600 to about 900 mg). In some embodiments innovative anti-arrhythmic agents can be used with unconventional anti-arrhythmic mechanisms, such as stretch receptor antagonism, sodium-calcium exchanger blockade, late sodium channel inhibition, and gap junction modulation. These therapies have not yet reached clinical studies in AF but reports look promising.
In
In some embodiments, even if there is an anchoring structure within the LAA, an anchoring structure adjacent the LAA ostium can have electrodes disposed thereon to monitor and/or pace tissue adjacent the ostium. For example, in the embodiment in
While the implanted devices can be incorporated with sensing and/or stimulating functionality, the implanted devices, in some embodiments, include circuitry to process the monitored patient data and detect an arrhythmia. Processing the data can include known techniques, including filtering and amplifying a signal. Algorithms stored in the device can determine if, based on the data, AF is occurring. Upon the detection of an arrhythmia, the system can be adapted to automatically deliver a therapy, whether it is electrical pacing, drug delivery, or some other type of therapy.
In some embodiments the processing and detecting steps occur in a device external to the heart, whether they are underneath the patient's skin or external to the patient. For example, an external device can be secured to the patient using a harness such that the device is secured comfortably near the patient heart. The monitored data is transmitted to the external device, which can include the processing and detection components. Once an arrhythmia is detected, the external device then communicates a signal to the internal device to initiate the therapy. In some instances the data, raw or processed, is further transmitted to a remote location. For example, the data can be transmitted to a physician for review. In some instances the detection algorithm can be reprogrammed as needed, perhaps to provide better more accurate AF detection.
The implanted device or any external device can include memory to store data, either temporarily or permanently. The implanted device can stored a certain amount of data, such as in a first-in-first-out process, or it can transmit data to an external data, which then stores the data. In some embodiments only data just before, during, and following AF is desired. The system can be adapted to store in memory only data from that specific period of time. The stored data can additionally be reviewed by a health care provider as desired.
The implantable device can optionally include a power source, which is optionally rechargeable (such as by inductive charging). The power source can power the sensing and/or pacing electrodes, or any other electrically driven activities performed by the implant. The power source is disposed in the implant and is in electrical communication with any monitoring and/or pacing electrodes.
The device can be adapted with additional sensors to acquire data to calculate or determine any of the following: AF burden (i.e., the time the patient is in AF as compared to sinus rhythm), left atrial pressure, temperature, transthoracic impedance (surrogate for pulmonary fluid status, i.e., “CHF”), impending atrial fibrillation or ventricular fibrillation. The implant can also include a pulse counter.
Each of the distal and proximal anchors has a looped configuration, the two ends of which are secured to hub. The loops are longer than they are wide. In their expanded configurations, the anchors 806 and 810 extend substantially radially outward from hub 808, and are generally orthogonal to the longitudinal axis of hub 808. In other words, in the side view shown in
In this embodiment the anchoring portion, including the eight anchors and the hub, is formed by laser cutting a single nitinol tube. The anchors and hub need not be formed from the same starting material, and can be secured to one another, such as by welding. The hub and the anchors need not be the same type of material. Materials other than nitinol can be used, and other cutting methods can be used.
In this embodiment, after the necessary material has been removed during the laser cutting process, the eight anchors are heat set in the deployed configurations shown in
The barriers can be a polyester material such as polyethylene terephthalate (“PET”; trade name Dacron®). The barriers can be other suitable materials, such as PTFE.
Proximal barrier 814 has pleats 816 formed therein between anchors 810. The pleats, or other rib formations, can help reduce the amount of material in the barrier, which can make it easier when the device is loaded into a delivery device. The pleats can help reduce the delivery profile of the device. The pleats or ribs also make it easier to accommodate dimensional changes of the anchor elements with compression on the barrier in the delivery configuration and tension on the barrier in the deployed configuration. Maintaining a low barrier thickness can also ease the loading process and maintain a minimal delivery profile of the device. The barrier material can be selected to have a specific porosity. The device includes two barriers 814 and 812, which effectively creates a two-ply barrier, and thereby reduces the amount of material that can escape the left atrial appendage and into the left atrium.
The barriers are adapted to prevent blood flow into the LAA, although they could be adapted to filter blood such that they prevent clots from flowing from the LAA into the left atrium. In alternative embodiments the device does not include distal barrier 812, such that the device only include a proximal barrier.
In an exemplary method of use, the device is used to occlude the left atrial appendage such that material in the left atrial appendage cannot enter the left atrium. Device 800 is first loaded into a delivery configuration in a delivery device, such as a catheter. Distal anchors 806 are deformed by collapsing them toward the longitudinal axis of the hub, so that they extend generally distally from the hub and are moved closer to one another. Proximal anchors 810 are also collapsed towards the longitudinal axis of the hub, moving them closer together such that they extend substantially proximally from the hub. The reconfiguration of proximal anchors 810 causes the barrier material 814 to bunch up, which is minimized by pleats, ribs, or other similar features. Pleats or ribs can also be incorporated into the distal barrier 812. The device can be front-loaded into a distal end of the delivery device, such that the proximal anchors are deformed before the distal anchors.
In use, after the device has been advanced within the patient adjacent the left atrial appendage (as described above), the distal anchors and distal barrier are first deployed from the delivery device into the left atrial appendage. Anchors 806 deform towards their deployed configuration shown in
It should be noted that before the proximal anchors are deployed, if the position of the deployed distal anchors is not optimal, the catheter can be advanced distally, deforming the distal anchors forward towards their delivery configurations, while recapturing the distal anchors within the delivery device.
Device 800 can similarly be adapted to include sensing and/or treatment features to sense and treat cardiac arrhythmias. For example, one or more of the anchors 810 or 806 can have one or more electrodes disposed thereon adapted to delivery energy to cardiac tissue to pace the tissue in the event of a detected atrial fibrillation. Alternatively, hub 808 can have a cylindrically shaped drug delivery device disposed therein, which is adapted to deliver a drug or other agent into the left atrial appendage, examples of which are disclosed above.
While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the disclosure. It should be understood that various alternatives to the embodiments of the disclosure described herein may be employed in practicing the disclosure.
Claims
1. An implantable cardiac orifice occlusion and arrhythmia treatment device, comprising:
- an anchoring portion adapted to anchor the device in place adjacent a cardiac orifice;
- a barrier element secured to the anchoring portion and adapted to cover the orifice when implanted, and adapted to prevent blood clots from passing through the barrier element; and
- an arrhythmia treatment element secured to at least one of the anchoring portion and the barrier element, the treatment element adapted to treat a detected cardiac arrhythmia.
2. The device of claim 1 further comprising an electrical activity monitoring element adapted to monitor electrical activity of the heart indicative of the arrhythmia.
3. The device of claim 2 where the monitoring element is adapted to be disposed in contact with atrial tissue to monitor electrical activity of the heart.
4. The device of claim 2 wherein the monitoring element is adapted to be disposed in contact with atrial appendage tissue to monitor electrical activity of the heart.
5. The device of claim 2 wherein the monitoring element comprises an arrhythmia detection component adapted to detect when the arrhythmia is occurring.
6. The device of claim 5 wherein the treatment element is adapted to treat the arrhythmia when the arrhythmia is detected by the detection component.
7. The device of claim 5 wherein the monitoring element comprises an arrhythmia detection component adapted to detect when atrial fibrillation is occurring.
8. The device of claim 2 wherein the anchoring portion, the barrier element, the monitoring element, and the treatment element are integrated into a singular implantable device.
9. The device of claim 2 further comprising a detector adapted to detect when the arrhythmia is occurring, the detector is disposed external to the patient, wherein the monitor is adapted to transmit data indicative of the electrical activity of the heart to the detector.
10. The device of claim 1 wherein the treatment element is adapted to pace cardiac tissue to treat the detected arrhythmia.
11. The device of claim 1 wherein the treatment element is adapted to deliver a therapeutic agent to cardiac tissue to treat the detected arrhythmia.
12. The device of claim 1 wherein the anchoring portion, the barrier element, and the treatment element are integrated into a singular implantable device.
13. The device of claim 1 wherein the anchoring portion comprises a distal deformable anchoring portion and a proximal deformable anchoring portion, the distal anchoring portion adapted to be deployed in a left atrial appendage and anchored to left atrial appendage tissue, wherein the proximal anchoring portion is adapted to be deployed in a left atrium and anchored to left atrial tissue.
14. A method of cardiac orifice blocking and arrhythmia treatment, comprising:
- an integrated implantable device comprising an anchoring portion, a barrier element, a monitor, and a treatment element;
- anchoring the anchoring portion against cardiac tissue near a cardiac orifice to block the flow of clots through the orifice with the barrier;
- positioning the monitor to be in contact with cardiac tissue to monitor cardiac activity indicative of an arrhythmia; and
- providing for the treatment of the arrhythmia with the treatment element.
15. The method of claim 14 wherein the positioning step comprises positioning the monitoring component against atrial tissue.
16. The method of claim 14 wherein the positioning step comprises positioning the monitoring component against atrial appendage tissue.
17. The method of claim 14 wherein the anchoring step comprises allowing the anchoring portion to deform from a delivery configuration towards a deployed configuration in which it anchors against cardiac tissue.
18. A cardiac orifice blocking device, comprising:
- an anchoring portion comprising a proximal anchoring portion and a distal anchoring portion, the proximal anchoring portion adapted to be anchored against left atrial tissue, and the distal anchoring portion adapted to be anchored against left atrial appendage tissue;
- a hub secured to the proximal and distal anchoring portions;
- a barrier portion comprising a proximal barrier secured to the proximal anchoring portion, the proximal barrier adapted to prevent blood clots from passing therethrough, and a distal barrier portion secured to the distal anchoring portion.
19. The device of claim 18 wherein the proximal anchoring portion has a greater radial dimension in a deployed configuration that a radial dimension of the distal anchoring portion in a deployed configuration.
20. The device of claim 18 wherein the proximal anchoring portion comprises a plurality of deformable anchoring elements that extend substantially radially outward from the hub in their deployed configurations.
21. The device of claim 18 wherein the proximal anchoring portion comprises a plurality of deformable anchoring elements, each of the plurality of anchoring elements having a loop configuration.
22. The device of claim 21, wherein the plurality of anchoring elements are in the same plane in a side view of the device.
23. The device of claim 22 wherein the plane is substantially orthogonal to a longitudinal axis of the hub.
24. The device of claim 20 wherein the distal anchoring portion comprises a plurality of deformable anchoring elements that extend substantially radially outward from the hub in their deployed configurations.
25. The device of claim 18 wherein the distal anchoring portion comprises a plurality of deformable anchoring elements, each of the plurality of anchoring elements having a loop configuration.
26. The device of claim 25 wherein the plurality of anchoring elements are in the same plane in a side view of the device.
27. The device of claim 26 wherein the plane is substantially orthogonal to a longitudinal axis of the hub.
28. The device of claim 18 wherein the proximal barrier is secured proximal to the proximal anchoring portion.
29. The device of claim 18 wherein the distal barrier is secured proximal to the distal anchoring portion.
30. The device of claim 18 wherein the proximal barrier comprises at least one pleat in the barrier material.
31. The device of claim 18 wherein the proximal barrier has a substantially circular configuration.
32. The device of claim 18 wherein the distal barrier has a substantially circular configuration.
33. The device of claim 18 wherein the proximal anchoring portion comprises a plurality of deformable proximal anchoring elements that extend substantially radially outward from the hub in their deployed configurations, and the distal anchoring portion comprises a plurality of deformable distal anchoring elements that extend substantially radially outward from the hub in their deployed configurations, wherein the proximal anchoring elements extend further radially outward than the distal anchoring elements.
34. The device of claim 18 wherein the distal anchoring portion and the proximal anchoring portion are formed integrally with the hub.
35. The device of claim 18 wherein the proximal barrier has a greater radial dimension than the distal barrier when the distal and proximal anchoring portions are in their respective deployed configurations.
Type: Application
Filed: Feb 8, 2012
Publication Date: Nov 8, 2012
Inventors: Randell L. Werneth (San Diego, CA), David Zarbatany (Laguna Niguel, CA)
Application Number: 13/368,685
International Classification: A61B 5/02 (20060101); A61F 2/01 (20060101);