Implantable medical electrical stimulation lead fixation method and apparatus
First Claim
1. A method of providing electrical stimulation of body tissue at a pelvic region stimulation site employing an implantable pulse generator comprising:
- providing an implantable medical lead comprising;
at least one shape memory polymer portion that has a first configuration and a second configuration, wherein the second configuration is obtained upon exposure of the shape memory polymer portion to a transition stimulus, and wherein the second configuration of the modifiable portion exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration;
at least one electrode configured to provide electrical stimulation of body tissue, the at least one electrode being positioned distally of the shape memory polymer portion; and
at least one proximal connector element formed in a connector array in a proximal segment of the lead body;
percutaneously introducing the implantable medical lead adjacent to the pelvic region stimulation site such that a distance of the electrode to the stimulation site is less than a distance of the at least one shape memory polymer portion to the stimulation site;
applying a transition stimulus to at least the at least one shape memory polymer portion of the lead while maintaining the electrode in the position where the distance of the electrode to the stimulation site is the same as before applying the transition stimulus and is less than a distance of the at least one shape memory polymer portion to the stimulation site; and
coupling the at least one proximal connector element with the implantable pulse generator.
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Abstract
An implantable medical electrical lead for electrical stimulation of body tissue that includes at least one shape memory polymer portion that has a first configuration and a second configuration, wherein the second configuration is obtained upon exposure of the shape memory polymer portion to a transition stimulus, and wherein the second configuration of the modifiable portion exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration; and at least one electrode configured to provide electrical stimulation of body tissue, wherein the lead has a proximal end and a distal end. Systems and kits as well as methods of utilizing the leads of the invention are also included.
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Citations
11 Claims
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1. A method of providing electrical stimulation of body tissue at a pelvic region stimulation site employing an implantable pulse generator comprising:
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providing an implantable medical lead comprising; at least one shape memory polymer portion that has a first configuration and a second configuration, wherein the second configuration is obtained upon exposure of the shape memory polymer portion to a transition stimulus, and wherein the second configuration of the modifiable portion exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration; at least one electrode configured to provide electrical stimulation of body tissue, the at least one electrode being positioned distally of the shape memory polymer portion; and at least one proximal connector element formed in a connector array in a proximal segment of the lead body; percutaneously introducing the implantable medical lead adjacent to the pelvic region stimulation site such that a distance of the electrode to the stimulation site is less than a distance of the at least one shape memory polymer portion to the stimulation site; applying a transition stimulus to at least the at least one shape memory polymer portion of the lead while maintaining the electrode in the position where the distance of the electrode to the stimulation site is the same as before applying the transition stimulus and is less than a distance of the at least one shape memory polymer portion to the stimulation site; and coupling the at least one proximal connector element with the implantable pulse generator. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A method of providing electrical stimulation of body tissue at a pelvic region stimulation site employing an implantable pulse generator comprising:
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providing an implantable medical lead having a proximal end and a distal end, comprising; at least one shape memory polymer portion that has a first configuration and a second configuration, wherein the second configuration is obtained upon exposure of the shape memory polymer portion to a transition stimulus, and wherein the second configuration of the modifiable portion exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration; at least one electrode configured to provide electrical stimulation of body tissue; and at least one proximal connector element formed in a connector array in a proximal segment of the lead body; percutaneously introducing the distal end of the implantable medical lead into a foramen while maintaining the shape memory polymer portion proximal of the foramen; applying a transition stimulus to at least the at least one shape memory polymer portion of the lead; and coupling the at least one proximal connector element with the implantable pulse generator.
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11. A method of providing electrical stimulation of body tissue at a stimulation site employing an implantable pulse generator comprising:
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providing an implantable medical lead comprising; at least one shape memory polymer portion that has a first configuration and a second configuration, wherein the second configuration is obtained upon exposure of the shape memory polymer portion to a transition stimulus, and wherein the second configuration of the modifiable portion exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration; at least one electrode configured to provide electrical stimulation of body tissue, the at least one electrode being positioned distally of the shape memory polymer portion; and at least one proximal connector element formed in a connector array in a proximal segment of the lead body; percutaneously introducing the implantable medical lead adjacent to the stimulation site; applying a transition stimulus to at least the at least one shape memory polymer portion of the lead while the at least one shape memory polymer portion is located between a pelvis and a dorsal surface to transition the at least one shape memory polymer portion from the first configuration to the second configuration and maintaining a position of the at least one electrode at the pelvis during the transition; and coupling the at least one proximal connector element with the implantable pulse generator.
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Specification