Implantable lead with dissolvable coating for improved fixation and extraction
First Claim
1. An intravascular lead, the lead including:
- an insulating elongate body having a proximal and a distal end and a peripheral surface;
at least one elongate electrical conductor, having a proximal end and a distal end, the conductor carried within the elongate body and extending longitudinally along substantially the entire length between the proximal and distal ends of the elongate body;
at least one electrode located at or near the distal end of the elongate body, the electrode being coupled to the distal end of the conductor; and
an at least partially dissolvable coating at least partially on an insulating portion of the peripheral surface at or near the distal end of the elongate body, the coating providing at least one of a rough surface, a porous surface after being exposed to an aqueous substance.
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Accused Products
Abstract
A cardiac rhythm management system provides an endocardial cardiac rhythm management lead with an at least partially dissolvable coating at least partially on insulating portions of the lead body at or near its distal end. Upon dissolution, the coating promotes tissue ingrowth to secure the lead in place within fragile vascular structures or elsewhere. Dissolution of one such coating releases a therapeutic agent, such as a steroid that modifies the fibrotic scar tissue content of tissue ingrowth, such that the resulting bond between the tissue and the lead is weak, so that the lead can be easily extracted if desired. One such lead includes an insulating elongate body carrying at least. The lead also includes an at least partially dissolvable coating on an insulating portion of the peripheral distal lead surface. The coating provides one or more of a rough surface, a porous surface, or a swollen surface after being exposed to an aqueous substance.
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Citations
41 Claims
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1. An intravascular lead, the lead including:
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an insulating elongate body having a proximal and a distal end and a peripheral surface;
at least one elongate electrical conductor, having a proximal end and a distal end, the conductor carried within the elongate body and extending longitudinally along substantially the entire length between the proximal and distal ends of the elongate body;
at least one electrode located at or near the distal end of the elongate body, the electrode being coupled to the distal end of the conductor; and
an at least partially dissolvable coating at least partially on an insulating portion of the peripheral surface at or near the distal end of the elongate body, the coating providing at least one of a rough surface, a porous surface after being exposed to an aqueous substance. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 11, 36)
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10. An intravascular lead, the lead including:
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an insulating elongate body having a proximal and a distal end and a peripheral surface;
at least one elongate electrical conductor, having a proximal end and a distal end, the conductor carried within the elongate body and extending longitudinally along substantially the entire length between the proximal and distal ends of the elongate body;
at least one electrode located at or near the distal end of the elongate body, the electrode being coupled to the distal end of the conductor; and
an at least partially dissolvable coating at least partially on an insulating portion of the peripheral surface at or near the distal end of the elongate body, the coating providing at least one of a rough surface, a porous surface, and a swollen surface after being exposed to an aqueous substance;
in which the coating also covers at least part of the at least one electrode.
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12. An intravascular lead for providing cardiac rhythm management therapy, the lead including:
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a flexible insulating elongate body having a proximal and a distal end and a peripheral surface;
a plurality of elongate electrical conductors, each conductor having a proximal end and a distal end, each conductor carried within the elongate body and extending longitudinally along substantially the entire length between the proximal and distal ends of the elongate body;
a plurality of electrodes located at or near the distal end of the elongate body, each electrode being coupled to the distal end of at least one of the conductors; and
a partially dissolvable coating at least partially on an insulating portion of the peripheral surface at or near the distal end of the elongate body, the coating providing at least one of a rough surface, a porous surface, and a swollen surface after being exposed to an aqueous substance, the coating including a plurality of substantially soluble particles dispersed in a substantially insoluble silicone adhesive that is bonded to the insulating elongate body, and in which the substantially soluble particles are selected from the group consisting of dexamethasone, dexamethasone acetate and dexamethasone sodium phosphate. - View Dependent Claims (13, 14, 15, 16)
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17. An intravascular lead for providing cardiac rhythm management therapy, the lead including:
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a flexible insulating elongate body having a proximal and a distal end and a peripheral surface;
a plurality of elongate electrical conductors, each conductor having a proximal end and a distal end, each conductor carried within the elongate body and extending longitudinally along substantially the entire length between the proximal and distal ends of the elongate body;
a plurality of electrodes located at or near the distal end of the elongate body, each electrode being coupled to the distal end of at one of the conductors; and
a means for performing the functions of coating an insulating portion of the peripheral surface at or near the distal end of the elongate body, providing at least one of a rough surface, a porous surface, and a swollen surface, after being exposed to an aqueous substance, for fixation of tissue thereto.
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18. A cardiac rhythm management system, including:
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an electronics unit; and
a lead coupled to the electronics unit, the lead including;
an insulating elongate body having a proximal and a distal end and a peripheral surface;
at least one elongate electrical conductor, having a proximal end and a distal end, the conductor carried within the elongate body and extending longitudinally along substantially the entire length between the proximal and distal ends of the elongate body;
at least one electrode located at or near the distal end of the elongate body, the electrode being coupled to the distal end of the conductor; and
an at least partially dissolvable coating at least partially on an insulating portion of the peripheral surface at or near the distal end of the elongate body, the coating providing at least one of a rough surface, a porous surface, after being exposed to an aqueous substance.
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19. A method of providing cardiac rhythm management therapy, the method including:
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translumenally disposing a lead in a heart;
exposing the lead to an aqueous substance;
partially dissolving a coating at least partially on an insulating portion of the lead to provide at least one of a rough surface, a porous surface, and a swollen surface, thereby promoting tissue ingrowth. - View Dependent Claims (20, 21, 22, 23, 24, 25)
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26. A method of forming a leadwire, the method comprising:
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forming at least one elongate electrical conductor, having a proximal end and a distal end;
forming at least one electrode at and coupled to a distal end of the conductor;
forming an insulating elongate body covering substantially all of the conductor and leaving exposed at least a portion of the electrode;
coating portions of the insulating elongate body near the distal end of the conductor with an at least partially dissolvable coating, the coating providing at least one of a rough surface, a porous surface, and a swollen surface after being exposed to an aqueous substance. - View Dependent Claims (27, 28, 29, 30, 31, 32, 33, 34, 35)
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37. An intravascular lead, the lead including:
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an elongate body extending from a proximal and a distal end, and having an intermediate portion therebetween, the elongate body having an outer peripheral surface;
at least one elongate electrical conductor carried within the elongate body and extending longitudinally along substantially the entire length between the proximal and distal ends of the elongate body;
at least one electrode located at or near the distal end of the elongate body, the electrode being coupled to the distal end of the conductor; and
an at least partially dissolvable coating at least partially on an insulating portion of the outer peripheral surface at the intermediate portion of the body, the coating providing a swollen surface after being exposed to an aqueous substance, the coating configured to directly contact tissue. - View Dependent Claims (38, 39, 40, 41)
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Specification