Systems and methods for extracting an electrode lead
Systems and methods are provided for extracting an implanted lead from a patient's body. The system may include a dilator and a trephine for extracting the electrode lead. A sheath may be included that is advanced over the proximal end of an electrode lead until the distal end of the sheath abuts a collar of the electrode lead coupled to proximal fixation elements. The dilator may be rotatably and axially advanced over the sheath until the distal end of the dilator collapses the proximal fixation elements within a lumen of the dilator. The trephine may then be rotatably and axially advanced over the dilator such that a cutting edge of the trephine cuts tissue surrounding distal fixation elements of the electrode lead to thereby dislodge the electrode lead.
1 . A system for extracting an electrode lead comprising an implanted fixation element, the system comprising:
an electrode lead comprising a fixation element configured to anchor the electrode lead in or adjacent to tissue associated with one or more spine stabilizing muscles associated with local segmental control of a lumbar spine within a back of a patient;
a dilator having a lumen sized and shaped to receive a proximal end of the electrode lead therethrough such that the dilator is slideable along the electrode lead, a distal portion of the dilator configured to be advanced distally to separate tissue surrounding the electrode lead; and
a trephine having a lumen sized and shaped to receive a proximal end of the dilator therethrough, a distal portion of the trephine comprising a cutting edge configured to be advanced distally to cut tissue surrounding the fixation element to thereby dislodge the electrode lead.
2 . The system of claim 1 , wherein the distal portion of the dilator is configured to be advanced distally to collapse proximal fixation elements of the fixation element within the lumen of the dilator, and wherein the cutting edge of the trephine is configured to be advanced distally to cut tissue surrounding distal fixation elements of the fixation element to thereby dislodge the electrode lead.
3 . The system of claim 2 , further comprising:
a sheath having a lumen sized and shaped to receive a proximal end of the electrode lead therethrough such that the sheath is slideable along the electrode lead, a distal portion of the sheath configured to be advanced distally until it abuts a collar on the electrode lead that is coupled to the proximal fixation elements, thereby preventing further distal advancement of the sheath relative to the electrode lead,
wherein the lumen of the dilator is sized and shaped to receive a proximal end of the sheath therethrough such that the dilator is slideable along the sheath.
4 . The system of claim 3 , wherein the sheath comprises an outer diameter substantially equal to an outer diameter of the collar.
5 . The system of claim 2 , wherein the dilator is configured to be rotated as the distal portion of the dilator is advanced distally to collapse the proximal fixation elements within the lumen of the dilator.
6 . The system of claim 1 , wherein the distal portion of the dilator is tapered.
7 . The system of claim 6 , wherein a cross-sectional area of the distal portion of the dilator decreases distally toward a distal end of the dilator.
8 . The system of claim 1 , wherein the cutting edge of the distal portion of the trephine comprises a plurality of proximally extending concave edges circumferentially disposed along a distal end of the trephine.
9 . The system of claim 1 , wherein the cutting edge of the distal portion of the trephine is angled to facilitate cutting of the tissue surrounding the fixation element.
10 . The system of claim 1 , wherein the cutting edge of the distal portion of the trephine is further configured to cut at least a portion of the fixation element.
11 . The system of claim 1 , wherein the trephine is configured to be rotated as the cutting edge of the trephine is advanced distally to cut tissue surrounding the fixation element.
12 . The system of claim 1 , wherein a proximal portion of the trephine comprises a handle configured to facilitate rotation of the trephine by a user.
13 . The system of claim 1 , wherein at least one of the dilator or trephine comprises a rigid material.
14 . The system of claim 13 , wherein the rigid material is stainless steel.
15 . The system of claim 1 , wherein a proximal portion of the dilator comprises one or more textured surfaces configured to facilitate gripping of the dilator.
16 . The system of claim 15 , wherein the dilator comprises an alignment marker disposed between two of the one or more textured surfaces, the alignment marker configured to facilitate alignment of the cutting edge of trephine and the distal portion of the dilator.
17 . The system of claim 16 , wherein the alignment marker comprises a groove extending circumferentially along an outer surface of the dilator.
18 . The system of claim 16 , wherein the alignment marker comprises a smooth section between the two of the one or more textured surfaces.
19 . A method for extracting an electrode lead comprising a fixation element implanted in a patient's body, the method comprising:
advancing a dilator distally over a proximal end of the electrode lead to thereby separate tissue surrounding the electrode lead;
advancing a trephine distally over a proximal end of the dilator, such that a cutting edge at a distal portion of the trephine cuts tissue surrounding the fixation element to thereby dislodge the electrode lead; and
removing the electrode lead from the patient's body.
20 . The method of claim 19 , wherein advancing the dilator distally over the proximal end of the electrode lead comprises advancing the dilator distally over proximal fixation elements of the fixation element to thereby collapse the proximal fixation elements within the lumen of the dilator, and wherein advancing the trephine distally over the proximal end of the dilator comprises advancing the trephine distally, such that the cutting edge of the trephine cuts tissue surrounding distal fixation elements of the fixation element to thereby dislodge the electrode lead.
21 . The method of claim 20 , further comprising:
prior to advancing the dilator distally over the proximal end of the electrode lead, advancing a sheath distally over a proximal end of the electrode lead until a distal end of the sheath abuts a collar of the proximal fixation elements,
wherein advancing the dilator distally over the proximal end of the electrode lead comprises advancing the dilator distally over the proximal end of the sheath.
22 . The method of claim 19 , wherein advancing the dilator distally over the proximal end of the electrode lead comprises rotating the dilator as the dilator is advanced distally.
23 . The method of claim 19 , wherein advancing the trephine distally comprises rotating the trephine as the trephine is advanced distally to cut the tissue surrounding the fixation element.
24 . The method of claim 19 , further comprising cutting at least a portion of the fixation element by advancing the trephine distally over the fixation element to facilitate dislodgement of the electrode lead.
25 . The method of claim 19 , further comprising:
removing the electrode lead and dilator proximally through the lumen of the trephine; and
removing the trephine from the patient's body.
26 . A system for extracting an electrode lead comprising an implanted fixation element, the system comprising:
a dilator having a lumen sized and shaped to receive a proximal end of the electrode lead therethrough such that the dilator is slideable along the electrode lead, a distal portion of the dilator configured to be advanced distally to separate tissue surrounding the electrode lead, wherein the distal portion of the dilator is configured to be advanced distally to collapse proximal fixation elements of the fixation element within the lumen of the dilator; and
a trephine having a lumen sized and shaped to receive a proximal end of the dilator therethrough, a distal portion of the trephine comprising a cutting edge configured to be advanced distally to cut tissue surrounding distal fixation elements of the fixation element to thereby dislodge the electrode lead; and
a sheath having a lumen sized and shaped to receive a proximal end of the electrode lead therethrough such that the sheath is slideable along the electrode lead, a distal portion of the sheath configured to be advanced distally until it abuts a collar on the electrode lead that is coupled to the proximal fixation elements, thereby preventing further distal advancement of the sheath relative to the electrode lead,
wherein the lumen of the dilator is sized and shaped to receive a proximal end of the sheath therethrough such that the dilator is slideable along the sheath.