Implantable medical lead and system, and method of use thereof
First Claim
Patent Images
1. An implantable lead comprising:
- an elongate lead body comprising a proximal region, a distal region, and an intermediate region disposed between the proximal and distal regions;
means for providing electrical continuity between the proximal and distal regions comprising a plurality of proximal electrical contacts electrically coupled to a plurality of distal electrical contacts; and
means for reversibly stiffening the lead between the intermediate and distal regions while not stiffening the lead between the intermediate and proximal regions comprising means for receiving a stiffening member into the lead body for disposition between the intermediate region and the distal region, wherein the means for receiving a stiffening member includes means for indicating a radial position on the lead body at which a sharp member inserted into the lead body will not contact the means for providing electrical continuity.
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Accused Products
Abstract
Implantable medical leads, lead assemblies, and methods for implanting the leads into the human body, for example, for use within the epidural spaces of the spinal column to manage pain. A stylet lumen extends within the lead between a side-wall stylet entrance port and a lead distal region. In use, exemplary stylets may be inserted through the lead stylet port to stiffen only the distal portion of the lead, and the distal portion of the lead inserted through an introducer needle into the human body. The stiffened distal portion of the lead may be short and easily controllable.
49 Citations
26 Claims
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1. An implantable lead comprising:
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an elongate lead body comprising a proximal region, a distal region, and an intermediate region disposed between the proximal and distal regions; means for providing electrical continuity between the proximal and distal regions comprising a plurality of proximal electrical contacts electrically coupled to a plurality of distal electrical contacts; and means for reversibly stiffening the lead between the intermediate and distal regions while not stiffening the lead between the intermediate and proximal regions comprising means for receiving a stiffening member into the lead body for disposition between the intermediate region and the distal region, wherein the means for receiving a stiffening member includes means for indicating a radial position on the lead body at which a sharp member inserted into the lead body will not contact the means for providing electrical continuity. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A method for inserting an implantable lead into the human body, the method comprising:
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providing an elongate stiffening member having a proximal region and a distal region; providing an elongate lead body comprising;
a proximal region, a distal region, an intermediate region disposed between the proximal and distal regions, and a sidewall;
at least one conductor disposed within the lead body and extending from the lead body proximal region to the lead body distal region;
at least one proximal contact disposed in the lead body proximal region and in electrical contact with the at least one conductor;
at least one distal contact disposed in the lead body distal region and in electrical contact with the at least one conductor;
a lumen disposed through the lead body between the lead body distal region and the lead body intermediate region; and
a port providing access between the lead body sidewall and the lumen in the lead body intermediate region, wherein the port and lumen are dimensioned to slidably receive the elongate stiffening member,inserting the lead distal region into the human body while carrying the stiffening member at least partially within the lumen between the port and the lead distal region, inserting the stiffening member into the lead through the lead port before inserting the lead distal region into the human body retracting the stiffening member from the inserted lead distal region, and sealing the port after retracting the stiffening member by sliding a sealing sleeve over the port. - View Dependent Claims (10)
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11. A method for inserting an implantable lead into the human body, the method comprising:
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providing an elongate stiffening member having a proximal region and a distal region; providing an elongate lead body comprising;
a proximal region, a distal region, an intermediate region disposed between the proximal and distal regions, and a sidewall;
at least one conductor disposed within the lead body and extending from the lead body proximal region to the lead body distal region;
at least one proximal contact disposed in the lead body proximal region and in electrical contact with the at least one conductor;
at least one distal contact disposed in the lead body distal region and in electrical contact with the at least one conductor;
a lumen disposed through the lead body between the lead body distal region and the lead body intermediate region; and
a port providing access between the lead body sidewall and the lumen in the lead body intermediate region, wherein the port and lumen are dimensioned to slidably receive the elongate stiffening member,inserting the lead distal region into the human body while carrying the stiffening member at least partially within the lumen between the port and the lead distal region, inserting the stiffening member into the lead through the lead port before inserting the lead distal region into the human body retracting the stiffening member from the inserted lead distal region, and sealing the port after retracting the stiffening member by sliding a sealing sleeve over the port by applying a sealant to the port and the sealant, includes a curable sealant material and the sealing includes allowing the curable sealant to cure.
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12. A method for inserting an implantable lead into the human body, the method comprising:
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providing an elongate stylet having a proximal region and a distal region; providing an elongate lead body comprising;
a proximal region, a distal region, an intermediate region disposed between the proximal and distal regions, and a sidewall;
at least one conductor disposed within the lead body andextending from the lead body proximal region to the lead body distal region;
at least one proximal contact disposed in the lead body proximal region and in electrical contact with the at least one conductor;
at least one distal contact disposed in the lead body distal region and in electrical contact with the at least one conductor, a lumen disposed through the lead body between the lead body distal region and the lead body intermediate region;
wherein the lumen is dimensioned to slidably receive the elongate stylet;inserting the stylet through the lead body sidewall into the lumen in the lead body intermediate region at an indicia of radial position on the lead so that the stylet inserted into the lead body will not contact the conductor; and inserting the lead distal region into the human body while carrying the stylet at least partially within the lumen. - View Dependent Claims (13, 14, 15, 16, 17)
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18. An implantable lead comprising:
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an elongate lead body comprising a proximal region, a distal region, an intermediate region disposed between the proximal and distal regions, and a sidewall; at least one conductor disposed within the lead body and extending from the proximal region to the distal region; at least one proximal contact disposed in the lead body proximal region and in electrical contact with the at least one conductor, at least one distal contact disposed in the lead body distal region and in electrical contact with the at least one conductor, a lumen disposed through the lead body between the distal region and the intermediate region; and an indicia of a radial position on the lead body at which a stylet inserted into the lead body will not contact the conductor. - View Dependent Claims (19, 20, 21)
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22. An implantable lead assembly comprising:
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an elongate stiffening member having a proximal region and a distal region; an elongate lead body comprising a proximal region, a distal region, an intermediate region disposed between the proximal and distal regions, and a sidewall; at least one conductor disposed within the lead body and extending from the lead body proximal region to the lead body distal region; at least one proximal contact disposed in the lead body proximal region and in electrical contact with the at least one conductor; at least one distal contact disposed in the lead body distal region and in electrical contact with the at least one conductor; a lumen disposed through the lead body between the lead body distal region and the lead body intermediate region; wherein the lumen is dimensioned to slidably receive the elongate stiffening member; and a hole forming device including a body adapted to fit over the lead body, in which the hole forming device body includes a first channel therethrough forming an angle less than 60 degrees with the lead body longitudinal center axis. - View Dependent Claims (23, 24, 25, 26)
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Specification