Method of manufacturing a drug-eluting endocardial lead utilizing silicone elastomer as a drug carrier
First Claim
1. A method of manufacturing an endocardial lead, the method comprising:
- combining an inflammation-reducing drug with a drug carrying silicone elastomer to form a mixture thereof;
securing the endocardial lead to a jig;
dispensing the mixture to a distal portion of the endocardial lead; and
allowing the mixture to cure at the distal portion of the endocardial lead;
wherein allowing the mixture to cure comprises elevating the temperature of the jig to cure the mixture.
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Abstract
A drug-eluting endocardial lead and method of manufacture. The silicone elastomer of the present invention is ideally suited to a manufacturing environment due to its extended pot life and decreased curing time. A preferred silicone elastomer is comprised of a multi-part mixture having at least a base portion and a curing portion. Additionally, since curing does not begin until the base and curing portions are combined, the mixing can be physically undertaken closer to the location of the endocardial lead and the curing “clock” does not start until the mixing occurs and external heat is applied. Since the silicone elastomer formed by base and curing components have improved the pot life and curing characteristics, the mixture is suitable for mixing with a steroid and then dispensing into an endocardial lead tip thus eliminating current design limitations imposed by current art while concomitantly minimizing manufacturing costs.
41 Citations
18 Claims
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1. A method of manufacturing an endocardial lead, the method comprising:
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combining an inflammation-reducing drug with a drug carrying silicone elastomer to form a mixture thereof; securing the endocardial lead to a jig; dispensing the mixture to a distal portion of the endocardial lead; and allowing the mixture to cure at the distal portion of the endocardial lead; wherein allowing the mixture to cure comprises elevating the temperature of the jig to cure the mixture. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A method of manufacturing an endocardial lead, the method comprising:
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combining an inflammation-reducing drug with a drug carrying silicone elastomer to form a pourable mixture thereof; providing a chamber at the distal portion of the endocardial lead; securing the endocardial lead to a jig; dispensing the pourable mixture into a distal portion of the endocardial lead; and curing the pourable mixture in the distal portion of the endocardial lead; wherein the dispensing the pourable mixture comprises dispensing the mixture within the chamber; and wherein the curing comprises elevating the temperature of the jig to cure the pourable mixture within the chamber. - View Dependent Claims (10, 11)
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12. A method of manufacturing a drug-eluting lead containing drug-eluting means for dispensing a drug, the lead having a distal tip, the method comprising the steps of:
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providing the endocardial lead; securing the endocardial lead to a jig; combining an inflammation-reducing drug with a drug carrying silicone elastomer to form a mixture thereof; applying the mixture to the distal tip of the lead; and allowing the mixture to cure in place in the lead; wherein allowing the mixture to cure in place in the lead comprises elevating the temperature of the jig to cure the mixture. - View Dependent Claims (13, 14, 15, 16, 17, 18)
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Specification