Medical electrical lead with polymeric monolithic controlled release device and method of manufacture
First Claim
1. A medical electrical lead, comprising:
- an elongated insulative lead body having a proximal end and a distal end;
an elongated conductor having a proximal end and a distal end, mounted within said insulative lead body;
an electrode assembly having proximal and distal ends, mounted at the distal end of said insulative lead body, comprising an electrode head having a lumen open to the distal end of said electrode assembly;
a fixation helix rotatably mounted within said electrode assembly and having a proximal end located within said lumen of said electrode head and a distal end extending from the distal end of said electrode assembly;
a controlled release device containing a desired drug mounted to said electrode assembly, mounted around said fixation helix, said fixation helix rotatably mounted with respect said controlled release device, said controlled release device having an interior surface surrounding said fixation helix adapted for elution of said desired drug from said interior surface into said lumen of said electrode head, said controlled release device being sufficiently dimensionally stable such that expansion of said controlled release device in the presence of body fluids does not interfere with rotation of said fixation helix; and
an electrode surface, mounted to said electrode head, coupled to the distal end of said elongated conductor.
1 Assignment
0 Petitions
Accused Products
Abstract
A cardiac pacing lead or other stimulation lead carrying a steroid compounded within a polymer matrix. The steroid is dispersed in thermoplastic or thermoset polyurethane or polyurea forming monomers or prepolymers. The mixture is then chain extended by addition of the appropriate difunctional or multifunctional isocyanate, hydroxyl or amine curing agent to form a solid polymer. The resulting formulation is molded or cast into a desired shape, and incorporated in the distal end of a medical electrical lead, adjacent to or within the electrode. In a preferred embodiment, the medical lead employs an extendable helix which is screwed into body tissue, and the polymer containing the drug takes the form of a generally dimensionally stable annular member mounted to the lead, encircling the helix.
-
Citations
9 Claims
-
1. A medical electrical lead, comprising:
-
an elongated insulative lead body having a proximal end and a distal end; an elongated conductor having a proximal end and a distal end, mounted within said insulative lead body; an electrode assembly having proximal and distal ends, mounted at the distal end of said insulative lead body, comprising an electrode head having a lumen open to the distal end of said electrode assembly; a fixation helix rotatably mounted within said electrode assembly and having a proximal end located within said lumen of said electrode head and a distal end extending from the distal end of said electrode assembly; a controlled release device containing a desired drug mounted to said electrode assembly, mounted around said fixation helix, said fixation helix rotatably mounted with respect said controlled release device, said controlled release device having an interior surface surrounding said fixation helix adapted for elution of said desired drug from said interior surface into said lumen of said electrode head, said controlled release device being sufficiently dimensionally stable such that expansion of said controlled release device in the presence of body fluids does not interfere with rotation of said fixation helix; and an electrode surface, mounted to said electrode head, coupled to the distal end of said elongated conductor. - View Dependent Claims (2, 4, 5, 6, 7, 8)
-
-
3. A medical electrical lead comprising:
-
an elongated insulative lead body having a proximal end and a distal end; an elongated conductor having a proximal end and a distal end, mounted within said insulative lead body; an electrode assembly having proximal and distal ends, mounted at the distal end of said insulative lead body, comprising an electrode head having a lumen open to the distal end of said electrode assembly; a fixation helix having a proximal end located within said lumen of said electrode head and a distal end extending from the distal end of said electrode assembly; a controlled release device containing a desired drug and taking the form of a hollow cylinder, mounted within said electrode head, mounted around said fixation helix, said controlled release device having an interior surface surrounding said fixation helix and adapted for elution of said desired drug from said interior surface into said lumen of said electrode head, wherein said electrode head comprises a member having proximal and distal ends and an internal lumen and a cylindrical sleeve having proximal and distal ends mounted external to said member and extending distally from said member, said sleeve having inwardly directed projections around the circumference of said sleeve at the proximal and distal ends of said sleeve, the projections at the proximal end of said sleeve engaging said member, said controlled release device mounted at the distal end of said member, encircled by said sleeve, said inwardly directed projections at the distal end of said sleeve mounted distal to said controlled release device, whereby said controlled release device is mounted to and contained within said electrode head. - View Dependent Claims (9)
-
Specification