System and method for making and using a lead introducer for an implantable electrical stimulation system
First Claim
1. A lead introducer comprising:
- an insertion-needle assembly configured and arranged for receiving an electrical stimulation lead, the insertion-needle assembly having a proximal end, a distal end, and a longitudinal length extending from the proximal end to the distal end, the insertion-needle assembly comprising an outer insertion needle having a proximal end, a distal end, and a longitudinal length extending from the proximal end to the distal end;
a splittable member having a proximal end, a distal end, and a longitudinal length extending from the proximal end to the distal end, the splittable member comprising a proximal hub disposed at the proximal end, the splittable member defining a lumen configured and arranged for receiving at least a portion of the insertion-needle assembly, the splittable member comprisingat least two pull-apart tabs disposed on the proximal hub of the splittable member, andat least one splittable region extending along at least a portion of the longitudinal length of the splittable member from between the at least two pull-apart tabs, the at least one splittable region configured and arranged for separating when the at least two pull-apart tabs are pulled apart from one another in directions approximately orthogonal to the splittable member; and
a lead-stabilization feature disposed on or attachable to the splittable member, configured and arranged for receiving, and temporarily retaining, a portion of an electrical stimulation lead extending outward from the splittable member such that the lead does not move relative to the splittable member when the lead is received by the lead-stabilization feature and the outer insertion needle is being removed from the lead, wherein the lead-stabilization feature comprises a notch defined along the proximal hub of the splittable member, the notch configured and arranged to form an interference fit with a portion of the electrical stimulation lead extending outwardly from the proximal hub of the splittable member when the electrical stimulation lead is inserted into the lumen of the splittable member.
1 Assignment
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Accused Products
Abstract
A lead introducer includes an insertion-needle assembly configured for receiving an electrical stimulation lead, and a splittable member that defines a lumen configured for receiving a portion of the insertion-needle assembly. The splittable member includes at least two pull-apart tabs disposed on a proximal hub of the splittable member and at least one splittable region extending along at least a portion of a longitudinal length of the splittable member from between the pull-apart tabs. The at least one splittable region is configured for separating when the pull-apart tabs are pulled apart from one another in directions approximately orthogonal to the splittable member. A lead-stabilization feature is configured for receiving, and temporarily retaining, a portion of an electrical stimulation lead extending outward from the splittable member such that the electrical stimulation lead does not move relative to the splittable member when the electrical stimulation lead is received by the lead-stabilization feature.
94 Citations
19 Claims
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1. A lead introducer comprising:
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an insertion-needle assembly configured and arranged for receiving an electrical stimulation lead, the insertion-needle assembly having a proximal end, a distal end, and a longitudinal length extending from the proximal end to the distal end, the insertion-needle assembly comprising an outer insertion needle having a proximal end, a distal end, and a longitudinal length extending from the proximal end to the distal end; a splittable member having a proximal end, a distal end, and a longitudinal length extending from the proximal end to the distal end, the splittable member comprising a proximal hub disposed at the proximal end, the splittable member defining a lumen configured and arranged for receiving at least a portion of the insertion-needle assembly, the splittable member comprising at least two pull-apart tabs disposed on the proximal hub of the splittable member, and at least one splittable region extending along at least a portion of the longitudinal length of the splittable member from between the at least two pull-apart tabs, the at least one splittable region configured and arranged for separating when the at least two pull-apart tabs are pulled apart from one another in directions approximately orthogonal to the splittable member; and a lead-stabilization feature disposed on or attachable to the splittable member, configured and arranged for receiving, and temporarily retaining, a portion of an electrical stimulation lead extending outward from the splittable member such that the lead does not move relative to the splittable member when the lead is received by the lead-stabilization feature and the outer insertion needle is being removed from the lead, wherein the lead-stabilization feature comprises a notch defined along the proximal hub of the splittable member, the notch configured and arranged to form an interference fit with a portion of the electrical stimulation lead extending outwardly from the proximal hub of the splittable member when the electrical stimulation lead is inserted into the lumen of the splittable member. - View Dependent Claims (2, 3, 4, 5, 6, 12, 13, 14, 15, 16, 17, 18, 19)
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7. A lead introducer comprising:
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an insertion-needle assembly configured and arranged for receiving an electrical stimulation lead, the insertion-needle assembly having a proximal end, a distal end, and a longitudinal length extending from the proximal end to the distal end, the insertion-needle assembly comprising an outer insertion needle having a proximal end, a distal end, and a longitudinal length extending from the proximal end to the distal end; a splittable member having a proximal end, a distal end, and a longitudinal length extending from the proximal end to the distal end, the splittable member comprising a proximal hub disposed at the proximal end, the splittable member defining a lumen configured and arranged for receiving at least a portion of the insertion-needle assembly, the splittable member comprising at least two pull-apart tabs disposed on the proximal hub of the splittable member, and at least one splittable region extending along at least a portion of the longitudinal length of the splittable member from between the at least two pull-apart tabs, the at least one splittable region configured and arranged for separating when the at least two pull-apart tabs are pulled apart from one another in directions approximately orthogonal to the splittable member; and a lead-stabilization feature disposed on or attachable to the splittable member, configured and arranged for receiving, and temporarily retaining, a portion of an electrical stimulation lead extending outward from the splittable member such that the lead does not move relative to the splittable member when the lead is received by the lead-stabilization feature and the outer insertion needle is being removed from the lead, wherein the lead-stabilization feature comprises a bracket removably coupleable to the splittable member and separate from the outer insertion needle. - View Dependent Claims (8, 9, 10, 11)
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Specification