Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical energy applicator
Reexamination Certificate
2000-01-20
2001-10-09
Getzow, Scott M. (Department: 3737)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical energy applicator
Reexamination Certificate
active
06301507
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to medical electrical leads, and methods of making, implanting and using same.
BACKGROUND OF THE INVENTION
It is well known in the field of medical electrical leads that proper coupling of stimulating electrodes to the right atrial wall is problematic, especially in respect of single pass DDD leads.
Over the years various attempts have been made to solve this problem by providing, for example, leads having positive affixation devices attached at or near the distal ends thereof such as screws, barbs and hooks, or by forming pre-formed J shapes or other configurations in the atrial portions of such leads.
See, for example, U.S. Pat. No. 4,154,247 to O'Neil for “Formable cardiac pacer lead and method of assembly and attachment to a body organ”, U.S. Pat. No. 4,401,126 to Reenstierna for “Endocardial implantable lead for pacemaker” and U.S. Pat. No. 4,627,439 to Harris for “Prebent ventricular/atrial cardiac pacing lead”, all of which are hereby incorporated by reference herein, each in its respective entirety. The foregoing patents all disclose single pass DDD leads having preshaped portions configured to cause the atrial electrode(s) thereof to appropriately contact and stimulate the right atrial wall.
While the leads disclosed in the foregoing patents solve some of the problems existing in the prior art respecting appropriate atrial electrode coupling in single pass leads, they produce no solution to the overriding problem, which is to provide a lead capable of providing good atrial coupling along the right atrial wall in a variety of heart shapes and sizes.
In addition to the problem of pre-formed single pass DDD leads not providing adequate electrode coupling under a variety of different physiologic conditions, there also exists the problem of implanting more than one lead in a human heart when reliable pacing of both the right atrium and right ventricle is to be carried out. In such a situation separate leads are typically implanted in the right atrium and in the right ventricle. Implanting two leads in a patient presents a challenge to the implanting physician because inserting two leads into the heart via the superior vena cava increases the surgical difficulty of the implantation procedure. Thus, while separate leads generally provide superior electrode coupling, they also present certain difficulties to the implanting physician.
The foregoing problems assume increased emphasis today owing to recent developments in heart failure treatment via pacing techniques. Effective, reliable pacing of the right atrium now assumes increased importance when treating heart failure.
Optimally pacing in heart failure includes pacing of four chambers of the heart. At a minimum, it is desirable to stimulate the left side of the heart via the intravenous route extending from the right side of the heart where synchronization of the cardiac cycle takes place via sensing of right atrial signals.
Thus, there exists a need to provide a medical electrical lead capable of solving the foregoing problems.
SUMMARY OF THE INVENTION
The present invention has certain objects. That is, the present invention provides solutions to problems existing in the prior art. Such problems include: (a) single pass DDD medical electrical leads which do not provide reliable effective coupling of the atrial electrodes thereof to the right atrial wall; (b) medical electrical leads having pre-bent or pre-curved atrial portions which do not provide good electrical coupling to the right atrial wall; (c) single pass DDD leads having atrial portions and electrodes and associated therewith that following implantation do not remain coupled to the right atrial wall; (d) medical electrical leads having a pre-formed or pre-curved atrial portions do not remain positionally or mechanically stable in respect of electrode coupling following implantation in the right atrium; and (e) medical electrical leads having atrial sections and associated electrodes which are difficult to appropriately position to permit good electrode coupling to the right atrial wall during implantation.
The present invention has certain advantages. Various embodiments of the present invention have one or more of the following advantages: (a) providing enhanced electrode coupling for stimulation of the right atrium; (b) remaining positionally and mechanically stable within the right atrium following implantation; (c) simplifying and easing implantation of a single pass DDD lead; and (d) providing a medical electrical lead which causes the atrial electrodes thereof to be pushed against the right atrial wall or right atrial sinus wall either through the action of gravity or a pushing force exerted by a pre-configured atrial section thereof.
The present invention has certain features. Various embodiments of the present invention have one or more of the following features: (a) a medical electrical lead having a substantially U-shaped atrial section having one or more atrial stimulation electrodes disposed thereon; (b) a medical electrical lead having an atrial section configured for implantation within the right atrium such that the electrode portion thereof is pushed against the right atrial wall by forces acting on the atrial section exerted by gravity or regions of heart located near the superior vena cava and/or the tricuspid valve; (c) a medical electrical lead having an atrial section comprising five distinct portions: a first proximal atrial portion; a second atrial portion; a third atrial portion; a fourth atrial portion; and a distal fifth atrial portion, where the third portion has at least one electrode disposed thereon for effecting atrial stimulation, the atrial section being geometrically configured to provide a pushing force to urge the at least one electrode against a right atrial wall or right atrial sinus wall; (d) a medical electrical lead having a pre-formed atrial section configured to cause at least one atrial electrode thereof to be pushed against a right atrial wall or right atrial sinus wall, portions of the lead disposed distally from the atrial section being configured for implantation within a right ventricle, a coronary sinus and/or a great cardiac vein of the patient's heart; (e) an elongated medical electrical lead for intra-cardiac electrical stimulation of a heart of a patient, the lead comprising a lead body extending between a proximal end of the lead and a distal end of the lead; a proximal lead portion configured for attachment of the proximal end of the lead body to an electrical pulse generator; a distal portion, comprising a distal-most section comprising at least a first electrode, the distal-most section being configured and dimensioned to permit the first electrode to engage cardiac tissue within one of a patient's ventricle and patient's great cardiac vein to permit electrical stimulation thereof; an atrial section disposed proximally from the distal-most portion and comprising at least a second electrode, the atrial section comprising an elongated first proximal atrial portion having a first orientation defined by a first imaginary axis disposed along a first major axis thereof, an elongated second atrial pre-formed portion having a second length and having a second orientation defined by a second imaginary axis disposed along a second major axis thereof, an elongated third atrial pre-formed portion having a third length and having a third orientation defined by a third imaginary axis disposed along a third major axis thereof, an elongated fourth atrial pre-formed portion having a fourth length and having a fourth orientation defined by a fourth imaginary axis disposed along a fourth major axis thereof, and an elongated fifth distal atrial portion having a fifth orientation defined by a fifth imaginary axis disposed along a fifth major axis thereof, a first curve defined by an angle &agr;
1
between the first imaginary axis and the second imaginary axis, the first curve separating the first proximal atrial portion from the second atrial pre-formed
Bakels Arnoldus
Lokhoff Nicolaas
Getzow Scott M.
Jaro Michael J.
Medtronic Inc
Pattom Harold
Woods Thomas F.
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