Medical electrical lead having variable bending stiffness
First Claim
1. An elongated implantable medical electrical lead for electrically stimulating a human heart or sensing electrical signals originating therefrom, comprising:
- (a) a lead body having proximal and distal sections;
(b) at least one electrode for sensing or electrically stimulating the heart;
(c) a proximal end comprising an electrical connector, the connector being contiguous with the proximal section of the lead body;
(d) a distal end connected to the distal section of the lead body;
(e) at least one electrical conductor having proximal and distal ends, the distal end of the conductor being operatively connected to the at least one electrode, the proximal end of the conductor being operatively connected to the electrical connector;
wherein the distal section of the lead body comprises at least first and second adjoining segments, the first segment being relatively stiff, the second segment being relatively flexible, the first segment being disposed distally in respect of the second segment, the first and second segments being configured and dimensioned to assume a minimum stored mechanical energy implantation position when the lead is implanted within the coronary venous anatomy of the heart such that additional mechanical energy from an external source must be exerted upon the lead body along an axial direction to move the lead axially from the minimum stored mechanical energy implantation position, the distal section of the lead body having an outer diameter ranging between about 0.5 mm and about 3 mm, the lead being adapted, sized and configured for placement in one or more of a coronary vein and a coronary sinus, and, wherein the lead body is configured and dimensioned such that when the lead is implanted within the heart the second segment is disposed in a distal portion of one of a great cardiac vein, a middle cardiac vein, a small cardiac vein, a posterior cardiac vein, an oblique left atrial vein, and an anterior cardiac vein.
1 Assignment
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Accused Products
Abstract
An elongated coronary vein lead having a variable stiffness lead body and most preferably adapted to be advanced into a selected coronary vein for delivering a pacing or defibrillation signal to a predetermined region of a patient'"'"'s heart, such as the left ventricle is disclosed. A method of pacing and/or defibrillating a patient'"'"'s heart using the lead is also described. The method of pacing or defibrillating the heart includes advancing the coronary vein lead through both the coronary sinus and into a selected coronary vein of a patient'"'"'s heart, connecting the lead to an electrical pacing source and applying electrical stimulation to a particular chamber of the patient'"'"'s heart via the implanted lead. The lead includes a variable stiffness lead body that enhances the ability of the lead to be retained in a coronary vein after the lead has been implanted therein.
380 Citations
51 Claims
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1. An elongated implantable medical electrical lead for electrically stimulating a human heart or sensing electrical signals originating therefrom, comprising:
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(a) a lead body having proximal and distal sections;
(b) at least one electrode for sensing or electrically stimulating the heart;
(c) a proximal end comprising an electrical connector, the connector being contiguous with the proximal section of the lead body;
(d) a distal end connected to the distal section of the lead body;
(e) at least one electrical conductor having proximal and distal ends, the distal end of the conductor being operatively connected to the at least one electrode, the proximal end of the conductor being operatively connected to the electrical connector;
wherein the distal section of the lead body comprises at least first and second adjoining segments, the first segment being relatively stiff, the second segment being relatively flexible, the first segment being disposed distally in respect of the second segment, the first and second segments being configured and dimensioned to assume a minimum stored mechanical energy implantation position when the lead is implanted within the coronary venous anatomy of the heart such that additional mechanical energy from an external source must be exerted upon the lead body along an axial direction to move the lead axially from the minimum stored mechanical energy implantation position, the distal section of the lead body having an outer diameter ranging between about 0.5 mm and about 3 mm, the lead being adapted, sized and configured for placement in one or more of a coronary vein and a coronary sinus, and, wherein the lead body is configured and dimensioned such that when the lead is implanted within the heart the second segment is disposed in a distal portion of one of a great cardiac vein, a middle cardiac vein, a small cardiac vein, a posterior cardiac vein, an oblique left atrial vein, and an anterior cardiac vein. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. An elongated implantable medical electrical lead for electrically stimulating a human heart or sensing electrical signals originating therefrom, comprising:
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(a) a lead body having proximal and distal sections;
(b) at least one electrode for sensing or electrically stimulating the heart;
(c) a proximal end comprising an electrical connector, the connector being contiguous with the proximal section of the lead body;
(d) a distal end connected to the distal section of the lead body;
(e) at least one electrical conductor having proximal and distal ends, the distal end of the conductor being operatively connected to the at least one electrode, the proximal end of the conductor being operatively connected to the electrical connector;
wherein the distal section of the lead body comprises at least first and second segments, the first segment having a bending stiffness Sb1, the second segment having a bending stiffness Sb2, Sb1, being greater than Sb2, the first segment being disposed distally in respect of the second segment, the first segment and the second segment being configured and characterized such that a distally directed force is imparted to the distal end of the lead when the first and second segments are subjected to a bending moment resulting in a sufficient curvature of the lead body, the bending moment being provided by an external force applied to the lead, the distal section of the lead body having an outer diameter ranging between about 0.5 mm and about 3 mm, the lead being adapted, sized and configured for placement in one or more of a coronary vein and a coronary sinus, and, wherein the lead body is configured and dimensioned such that when the lead is implanted within the heart the second segment is disposed in a distal portion of one of a great cardiac vein, a middle cardiac vein, a small cardiac vein, a posterior cardiac vein, an oblique left atrial vein, and an anterior cardiac vein. - View Dependent Claims (20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39)
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40. A method of electrically stimulating a patient'"'"'s heart with an implantable cardiac stimulator and an elongated implantable medical electrical lead, the lead comprising a lead body having proximal and distal sections, at least one electrode for sensing or electrically stimulating the heart, a proximal end comprising an electrical connector, the connector being contiguous with the proximal section of the lead body, a distal end connected to the distal section of the lead body, at least one electrical conductor having proximal and distal ends, the distal end of the conductor being operatively connected to the at least one electrode, the proximal end of the conductor being operatively connected to the electrical connector, wherein the distal section of the lead body comprises at least first and second adjoining segments, the first segment being relatively stiff, the second segment being relatively flexible, the first and second segments being configured and dimensioned to assume a minimum stored mechanical energy implantation position when the lead is implanted within the coronary venous anatomy of the heart such that additional mechanical energy from an external source must be exerted upon the lead body along an axial direction to move the lead axially from the minimum stored mechanical energy implantation position, the first segment being disposed distally in respect of the second segment, the distal section of the lead body having an outer diameter ranging between about 0.5 mm and about 3 mm, the lead being adapted, sized and configured for placement in one or more of a coronary vein and a coronary sinus, the method comprising:
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(a) providing the cardiac stimulator;
(b) providing the medical electrical lead;
(c) transvenously inserting and positioning the lead through a coronary sinus and into a coronary vein in the heart, (d) operatively connecting the connector of the lead to the cardiac stimulator; and
(e) delivering at least one electrical pulse originating in the cardiac stimulator through the lead and the at least one electrode to the heart. - View Dependent Claims (41, 42, 43, 44, 45)
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46. A method of electrically stimulating a patient'"'"'s heart with an implantable cardiac stimulator and an elongated implantable medical electrical lead, the lead comprising a lead body having proximal and distal sections, at least one electrode for sensing or electrically stimulating the heart, a proximal end comprising an electrical connector, the connector being contiguous with the proximal section of the lead body, a distal end connected to the distal section of the lead body, at least one electrical conductor having proximal and distal ends, the distal end of the conductor being operatively connected to the at least one electrode, the proximal end of the conductor being operatively connected to the electrical connector, wherein the distal section of the lead body comprises at least first and second adjoining segments, the first segment being relatively stiff, the second segment being relatively flexible, the first and second segments being configured to impart a distally directed force to the distal end of the lead when the segments are subjected to a bending moment resulting in a sufficient curvature of the distal section of the lead body, the first segment being disposed distally in respect of the second segment, the distal section of the lead body having an outer diameter ranging between about 0.5 mm and about 3 mm, the lead being adapted, sized and configured for placement in one or more of a coronary vein and a coronary sinus, the method comprising:
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(a) providing the cardiac stimulator;
(b) providing the medical electrical lead;
(c) transvenously inserting and positioning the lead through a coronary sinus and into a coronary vein in the heart, (d) operatively connecting the connector of the lead to the cardiac stimulator; and
(e) delivering at least one electrical pulse originating in the cardiac stimulator through the lead and the at least one electrode to the heart. - View Dependent Claims (47, 48, 49, 50, 51)
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Specification