Systems and Methods for Lead Fixation
US-2024042196-A1 · Feb 8, 2024 · US
US2026083963A1 · US · A1
| Field | Value |
|---|---|
| Publication number | US-2026083963-A1 |
| Application number | US-202519291287-A |
| Country | US |
| Kind code | A1 |
| Filing date | Aug 5, 2025 |
| Priority date | May 10, 2010 |
| Publication date | Mar 26, 2026 |
| Grant date | — |
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Devices, systems and methods for reducing migration of leads, catheters and similar devices are provided. In particular, devices, systems and methods are provided for creating a slack anchor which assists in maintaining the lead or catheter in a desired position. In some embodiments, the slack anchor is created within the epidural space. When targeting nerve anatomy within the spinal column or in the vicinity of the epidural space, anchoring within the epidural space allows the associated lead or catheter to be anchored as close to the target therapy site as desired or possible. By anchoring close to the target therapy site, the risk of movement or migration is significantly reduced or eliminated.
Opening claim text (preview).
1 . (canceled) 2 . A method of positioning a lead to electrically stimulate a dorsal root ganglion of a patient, the method comprising: advancing, in a first direction, a distal end of the lead from an entry point into an epidural space of the patient such that one or more electrodes of the lead are positioned proximate to the dorsal root ganglion; forming a slack anchor between electrodes of the lead and the entry point into the epidural space via introduction of an additional portion of a shaft of the lead into the epidural space in a second direction that is different from the first direction after the one or more electrodes of the lead are positioned proximate to the dorsal root ganglion, wherein the slack anchor comprises an undulating or loop shape; and delivering one or more stimulation pulses to the dorsal root ganglion via at least one of the one or more electrodes of the lead, the one or more stimulation pulses configured to treat a condition of the patient. 3 . The method of claim 2 , wherein a shaft of the lead comprises a kink point to assist formation of the undulating or loop shape in the epidural space. 4 . The method of claim 2 , wherein the undulating or loop shape comprises at least one switchback. 5 . The method of claim 2 , wherein the undulating or loop shape comprises one or more loops. 6 . The method of claim 2 , wherein the undulating or loop shape comprises a combination of switchbacks and loops. 7 . The method of claim 6 , wherein at least one loop of the one or more loops crosses over at least one of the one or more switchbacks. 8 . The method of claim 2 , wherein the one or more stimulation pulses are configured to treat a condition of the patient, and wherein the condition is selected from the list consisting of: pain, itching, a movement disorder, Multiple Sclerosis, a spinal cord injury, asthma, chronic heart failure, obesity, stroke, a peripheral vascular disease, or angina pectoris. 9 . The method of claim 2 , wherein the lead is advanced into the epidural space through an introducer sheath. 10 . The method of claim 9 , further comprising partially withdrawing the introducer sheath prior to introducing the additional portion of the lead into the epidural space. 11 . The method of claim 9 , wherein a flexibility of the distal end of the lead exceeds a flexibility of a distal end of the introducer sheath. 12 . The method of claim 11 , wherein a difference between the flexibility of the distal end of the lead and the flexibility of the distal end of the introducer sheath causes a shaft of the lead to bend. 13 . The method of claim 2 , wherein the slack anchor is configured to prevent a migration of the lead and maintain the one or more electrodes of the lead remain proximate to the dorsal root ganglion. 14 . The method of claim 2 , wherein the additional portion of the lead is more flexible than the distal end of the lead to cause the additional portion of the lead to form the undulating or loop shape in the epidural space. 15 . The method of claim 14 , wherein the one or more electrodes remain positioned proximate to the dorsal root ganglion after the slack anchor is formed. 16 . The method of claim 2 , further comprising: connecting the lead to an implantable pulse generator (IPG); and generating, by the IPG, the one or more stimulation pulses. 17 . The method of claim 16 , further comprising receiving, by the IPG, programming comprising one or more parameters, wherein the one or more stimulation pulses are generated based on the one or more parameters. 18 . The method of claim 17 , further comprising removing the slack anchor. 19 . The method of claim 17 , wherein frictional forces between a portion of the lead forming the slack anchor and the epidural space prevent migration of the lead. 20 . The method of claim 2 , wherein the lead comprises at least a first region and a second region, the first region positioned more distally relative to the second region, and wherein the first region is more flexible than the second region. 21 . The method of claim 2 , further comprising controlling the first direction and the second direction using a sheath configured to be advanced over at least a portion of the lead.
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