1. Field of the Invention
This invention pertains to a cardiac electrode assembly for pacing, sensing or applying signals to a tissue of a heart.
2. Description of the Prior Art
Cardiac electrodes have long been used on the heart for sensing electrical activity on the heart and for the treatment of a variety of disorders including cardiac asynchrony. Cardiac electrodes come in many varieties of shapes and sizes and configurations including a wide variety of features for securing the electrode to a tissue of the heart. For example, such electrodes may include so-called screw-in type or “pigtail” electrodes for burrowing into the tissue of the heart to secure the electrode on the heart. Also, electrodes can be urged against the heart to make contact with the heart surface. Such electrodes may be individually placed on the heart. Japanese Pat. No. 2271829 dated November 1990 shows electrodes for diagnosis of infarction. The electrodes are attached to a net temporarily surrounding the heart.
Cardiac electrodes may be placed percutaneously or surgically. A percutaneous placement includes advancing an electrode through the vasculature of the patient into a chamber of the heart and then placing the electrode in residence within the chamber of the heart. Percutaneous placement may also include placing an electrode near the epicardial surface of the heart by advancing the electrode into a coronary vessel near the epicardial surface.
A surgical placement includes surgically accessing the epicardial surface of the heart and placing electrodes on or near the epicardial surface. The surgical access may include minimally invasive surgical techniques.
Percutaneous delivery of electrodes has certain desirable features. For example, such a procedure is normally regarded as less invasive than a surgical access.
Notwithstanding advantages, percutaneous delivery of cardiac electrodes has limitations. For example, a percutaneous delivery for epicardial stimulation requires advancement of electrodes and their associated leads through the coronary vasculature of the patient. Such vasculature has a narrow diameter and often presents a tortuous path limiting the ability to place such electrodes. Further, even if an electrode can be advanced into the coronary vasculature, only a very limited surface area of the epicardium of the heart can be treated in this manner. Percutaneously accessible blood vessels may not be overlying the most desirable area of the heart for treatment. In contrast, a surgical delivery permits placement of an electrode at any location on the epicardium of the heart.
Pacing electrodes are typically driven by direct current (DC) voltage systems from an implantable pulse generator or other power source. Pacing electrodes are commonly either uni-polar or bi-polar.
A uni-polar electrode has a single contact near the tissue to be treated. Current flow from the electrode (normally positively charged) passes through tissue to a more remote electrical ground or oppositely polarized electrode (e.g., an exposed ground or negatively charged electrode on the implantable pulse generator).
A bi-polar electrode includes two oppositely charged electrodes to create a more focused and localized field of current flow through the target tissue. As a result, a bi-polar electrode assembly includes a pair of electrodes for any given treatment with an associated positive-voltage electrode coupled with an associated negative-voltage electrode.
Paired electrodes may have separate leads (conductors contained within flexible, bio-compatible, electrically insulating jackets) or the paired electrodes may have a common lead. An associated pair of electrodes with a common lead is the CapSure® Epi lead of Medtronic Inc., Minneapolis, Minn., U.S.A.
In the CapSure® Epi lead, a positive and a negative pacing electrode with separate flexible leads are connected to a common hub with a common lead extending from the hub to a connector. The connector can then be connected to an implantable pulse generator or other source of a pacing signal.
Paired electrodes such as the CapSure® Epi electrode assembly also have certain limitations. Where it is desirable to provide pacing over a wide surface area or at multiple locations on the heart, multiple electrode assemblies are required each with individual pairs of differently polarized electrodes creating separate fields for pacing. Accordingly, if three different areas are to be paced, six electrodes must be placed on the heart. Also, over time the desired location for optimized pacing may change. A previously placed electrode may no longer be in optimal location and the patient must either cope with sub-optimal pacing or endure a subsequent procedure for re-positioning of electrodes.
According to a preferred embodiment of the present invention, a cardiac electrode assembly is disclosed having an electrode lead with a plurality of electrical conductors in a common lead jacket. The electrical conductors include a primary conductor and at least a first secondary conductor. At a proximal end of the lead, the conductors terminate at a connector having a plurality of exposed electrical contacts. The contacts include a primary contact connected to the primary conductor and a secondary contact connected to the secondary conductor. A plurality of cardiac electrodes is mechanically connected to the distal end of the lead. The plurality includes a primary cardiac electrode and at least a secondary cardiac electrode (more preferably, at least two secondary cardiac electrodes) connected to one or more secondary conductors. In still preferred embodiments of the invention, multiple secondary conductors with separate leads in the common jacket are connected to the distal end of the common lead jacket.
With reference now to the various drawing figures in which identical elements are numbered identically throughout, a description of a preferred embodiment of the present invention will now be provided. The following patents and published applications, described elsewhere in this application, are incorporated herein by reference: U.S. Pat. No. 6,907,285 issued Jun. 14, 2005; U.S. Pat. No. 6,893,392 issued May 17, 2005; U.S. Pat. No. 5,702,343 issued Dec. 30, 1997; U.S. Pat. No. 6,123,662 issued Sep. 26, 2000; U.S. Pat. No. 6,482,146 issued Nov. 19, 2002; U.S. Pat. No. 6,730,016 issued May 4, 2004; U.S. Pat. No. 6,425,856 issued Jul. 30, 2002; U.S. Pat. No. 6,572,533 issued Jun. 3, 2003; and U.S. patent application Ser. No. 10/165,504 filed Jun. 7, 2002 and published Dec. 12, 2003 as Publication No. 2003-0229265A1.
Novel Electrode Assembly Design for IS-1 Connector
Referring first to
In the embodiment of
Each of conductors 162, 163, and 164 is sheathed in a highly flexible jacket 142, 143, and 144, which extend from a jacket hub 15 surrounding primary electrode E1. The material of jackets 14 and 142 through 144 (shown in phantom lines in
At a proximal end of the lead 12, a connector 20 is secured to the lead 12. In the embodiment of
Connectors such as the IS-1 connector 20 are well known and form no part of this invention per se. Such connectors are used for connection of cardiac electrode assemblies to implantable pulse generators as is known in the art.
With the embodiment of
The electrode assembly 10 of the present invention is placed with the electrodes E1 through E4 on the heart H. While the electrodes E1 through E4 are illustrated as exposed contacts (which make electrical connection by being urged against the heart), it will be appreciated that the electrodes E1 through E4 can take any configuration known in the art including so-called pigtail electrodes, which may have a portion which is imbedded within the heart tissue. Furthermore, through use of a needle placement or the like, one or more of the electrodes E1 through E4 may be fully imbedded within the tissue of the heart H. This is illustrated in
The electrode assembly 10 is connected to an implantable pulse generator 60 by the connector 20 inserted within a mating connector (not shown) on the implantable pulse generator 60 as is conventional for attachment of prior art electrode assemblies 50, 52. The implantable pulse generator 60 provides a signal to the conductors 16, 18 such that the primary electrode E1 may have a polarity indicating a positive charge and the electrodes E2 through E4 may be simultaneously negatively charged. In addition to application of a signal to the heart, the electrodes E2 through E4 may be used as sensing electrodes for delivering electrical signals from the heart H to monitoring or diagnostic equipment.
As a result of the placement thus described, the implantable pulse generator 60 may generate a positive polarity on contact 222 and a negative polarity on contact 221. As a result, three different electrical fields are created extending between the electrode pairs E1, E2; E1, E3 and E1, E4. As a result, three different pacing areas are provided with four electrodes where the prior art would require six such electrodes being placed on the heart.
Also, the prior art electrode assemblies (such as the CapSure® Epi electrode assembly) would require three pacing leads connected to a pulse generator to create three electrical fields on the heart. The present invention utilizes a single pacing lead 14. Since pulse generators have only a limited number of connector locations, a more effective pacing therapy is possible with the present invention.
A surgeon placing the electrode assembly 10 on the heart may place the primary electrode E1 in any desired location and extend the secondary electrodes E2 through E4 to any one of a number of desired locations on the heart limited only by the length of the secondary jackets E2 through E4. It is anticipated that a representative length of a secondary jacket 144 would be about 1 to 3 centimeters.
Variable Timing of Energizing Electrode Pairs
With the invention thus described, the secondary electrodes E2 through E4 all receive a negative charge during the pacing at the same instance as each of the other secondary electrodes E2 through E4. It may be desirable for the electrodes E2 through E4 be provided with a charge at different times to create a wave of paced tissue along the surface of the heart.
For example, and as illustrated in
Altering the timing of energizing the secondary electrodes may be accomplished by providing capacitors C2, C3 and C4 on each of secondary conductors 162 through 164 as illustrated in
Wireless Signal Transmission
As illustrated in
The explanted source of the pacing signal is illustrated as 70 in
Novel Electrode Assembly Design for IS-4 Connector
Such an IS-4 connector is schematically illustrated as connector 20′ in
The connector 20′ contains contacts 221′ through 224′ individually connected to separate conductors including a primary conductor 18′ connecting primary electrode E1′ to contact 221′. Secondary conductors 162′ through 164′ connect electrodes E2′ through E4′, respectively, to electrodes 222′ through 224′.
Each of the electrodes E2′ through E4′ may be independently controlled. The independent control may include a time delay control achieving the benefits associated with
Each of the electrodes E2′ through E4′ may be controlled so that a secondary electrode E2′ through E4′ is dormant for an extended period of time. Namely, from time to time, the location of a desired pacing site may change for a particular patient. After the assembly 10′ is initially placed, the most desirable pacing location may be identified as the pacing pair E1′ and E4′. Accordingly, electrodes E2′ and E3′ may be left dormant. Over time, for a particular patient, it may be determined that the most desirable pacing location has a shift to the pacing pair E1′ and E2′. As a result, internal circuitry within the implanted controller may be adjusted so that only that pair E1′, E2′ is now energized and the remaining secondary electrodes E3′ and E4′ are dormant.
Placement of Electrodes with a Carrier
While the electrodes E1 through E4 are most conveniently placed on the common lead 12 as illustrated in
While the jacket 100 could be non-therapeutic independently, the jacket 100 is preferably a device selected to provide a therapeutic benefit such as a device for treating congestive heart failure as disclosed in Assignee's U.S. Pat. No. 5,702,343 issued Dec. 30, 1997; U.S. Pat. No. 6,123,662 issued Sep. 26, 2000 and U.S. Pat. No. 6,482,146 issued Nov. 19, 2002. These patents describe a technique for treating congestive heart failure by placing a cardiac support device in the form of a jacket around the heart. In certain of the specific embodiments disclosed, the jacket is a knit of polyester material which surrounds the heart and which provides resistance to progressive diastolic expansion. Other described materials include metal such as stainless steel (the jacket of the present invention may also be made in whole or part of nitinol). In certain aspects, the knit side and open cell size are selected to minimize or control fibrosis. It is believed that such resistance decreases wall tension on the heart and permits a diseased heart to beneficially remodel.
Assignee's U.S. Pat. No. 6,730,016 issued May 4, 2004 describes a jacket with a non-adherent lining or coating. In certain embodiments, the coating is in specific locations (for example, over surface-lined cardiac blood vessels). Assignee's U.S. Pat. No. 6,425,856 issued Jul. 30, 2002 describes a cardiac jacket with therapeutic agents incorporated on the jacket for providing additional therapy to the heart. Assignee's U.S. Pat. No. 6,572,533 issued Jun. 3, 2003 describes a treatment on the left ventricle side of the heart only. Assignee's U.S. patent application Ser. No. 10/165,504 filed Jun. 7, 2002 and published Dec. 12, 2003 as Publication No. 2003-0229265A1 teaches a highly compliant cardiac jacket.
In
The electrodes E1 through E4 may be fixed to the jacket 100 at manufacture of the 100 jacket or may conveniently be attached to the jacket or the heart in the region of the jacket following placement of the jacket 100 on the heart.
Multiple Redundant Electrodes
Each of the electrodes of the array may be connected to a controller as previously described which may be fully implantable or may be activated through RF or other wireless transmission. Further, the electrodes may also be coupled to a controller (again, either hardwired or through wireless transmission) to provide sensing signals to the controller.
The size of the array is selected so that the number of electrodes is in excess of the number otherwise desired for providing sensing or pacing functions on the heart. Preferably, the electrodes of the array are secured to the fabric of the jacket 100 at time of manufacture and before placement on the heart.
As a result of the excess number of electrodes, there is a redundancy in the number of electrodes such that at the time of placing the jacket 100 on the heart, a surgeon need not be concerned with precise placement of any given electrode over any given location on the heart. Instead, after placement of the electrode jacket 100 on the heart, the electrodes of the array may be individually sensed for determining which of the electrodes is most preferably energized for optimizing a pacing function on the heart. Those electrodes may be energized by internal switches within the controller 70″. The remaining electrodes may be left dormant.
Over time, the location on the heart for optimized pacing may change. As a result, a patient may have all the electrodes of the array interrogated to sense and determine locations on the heart through which a pacing would be most beneficial. In the event such optimal locations have changed over time, the originally paced electrodes may be shifted to a dormant state and the newly identified optimal electrodes may be shifted from a dormant state to a paced state by the controller 70″.
It has been shown how the objects of the present invention have been achieved in a preferred embodiment. Modifications and equivalents of the disclosed concepts are intended to be included within the scope of the claims, which are appended hereto.