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US5733322A Expired / Lapsed US ⏱️ 0.0 years remaining

Positive fixation percutaneous epidural neurostimulation lead

Assignee: Medtronic Inc
•
Filing: 1995-05-23
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Granted: 1998-03-31
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Expires: 2015-05-23
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Abstract

Abstract A neurological epidural lead is disclosed having an extension that extends distally beyond the most distal electrode. The length of the extension corresponds to the length of one ore more vertebral segments. The lead is placed in the epidural space so that the electrodes are positioned as desired. In positioning the electrodes, the extension passes through at least one area where the epidural space between the dura and the spinal canal wall is very narrow because the dura and spinal canal wall are in contact. As a result, the extension is held in place by contact with both the dura and spinal canal wall so that lateral lead migration of the electrodes is minimized.

Inventors

  • 👤 Warren L. Starkebaum

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 14:31
CPC Classifications
A; A61; A61N; A61N1/00; A61N1/02; A61N1/04; A61N1/05; A61N1/0551

Claims Analysis

Total Claims: 37
Claim 1
Independent Claim 87 words
A neurological epidural lead having a proximal end and a distal end, the lead comprising: a body having at least two electrodes attached thereto near the distal end of the lead; a connector attached at the proximal end of the lead; wires connecting the electrodes to the connector; an extension extending distally beyond the most distal electrode, the extension adapted to remain entirely within the epidural space of a spinal column, wherein the length of the extension corresponds to the length of at least one vertebral segment.
Claim 2
Dependent Claim 87 words
A neurological epidural lead having a proximal end and a distal end, the lead comprising: a body having at least two electrodes attached thereto near the distal end of the lead; a connector attached at the proximal end of the lead; wires connecting the electrodes to the connector; an extension extending distally beyond the most distal electrode, the extension adapted to remain entirely within the epidural space of a spinal column, wherein the length of the extension corresponds to the length of at least one vertebral segment.
Claim 3
Dependent Claim 16 words
A lead according to claim 1 wherein the body is made of an electrically non-conducting material.
Claim 4
Dependent Claim 22 words
A lead according to claim 2 wherein the electrically non-conducting material is selected from a group consisting of polyurethane, polypropylene and silicone.
Claim 5
Dependent Claim 20 words
A lead according to claim 1 wherein the body is made of a material that is inert to body tissue.
Claim 6
Dependent Claim 15 words
A lead according to claim 1 wherein the electrodes are made of a conducting metal.
Claim 7
Dependent Claim 12 words
A lead according to claim 1 wherein the electrodes encircle the body.
Claim 8
Dependent Claim 13 words
A lead according to claim 1 wherein the number of electrodes is four.
Claim 9
Dependent Claim 13 words
A lead according to claim 1 wherein the number of electrodes is eight.
Claim 10
Dependent Claim 23 words
A lead according to claim 1 wherein the length from the most proximal electrode to the most distal electrode is about 30 millimeters.
Claim 11
Dependent Claim 32 words
A lead according to claim 1 wherein the electrodes are spaced from each other by portions of the body so that there is an electrically insulating space between each of the electrodes.
Claim 12
Dependent Claim 16 words
A lead according to claim 1 wherein the wires pass through the interior of the body.
Claim 13
Dependent Claim 18 words
A lead according to claim 1 wherein the extension is made of the same material as the body.
Claim 14
Dependent Claim 21 words
A lead according to claim 1 further comprising a stiffening member attached to the extension to add rigidity to the extension.
Claim 15
Dependent Claim 15 words
A lead according to claim 13 wherein the stiffening member is enclosed within the extension.
Claim 16
Dependent Claim 42 words
A lead according to claim 13 wherein the stiffening member is made of a material chosen from the group consisting of polymeric material and metallic material having a stiffness greater than a corresponding volume of material that the body is made of.
Claim 17
Dependent Claim 20 words
A lead according to claim 1 wherein the length of the extension is approximately 9 to 90 millimeters in length.
Claim 18
Dependent Claim 20 words
A lead according to claim 16 wherein the length of the extension is approximately 15 to 30 millimeters in length.
Claim 19
Dependent Claim 20 words
A lead according to claim 1 wherein the length of the extension is approximately 9 to 45 millimeters in length.
Claim 20
Dependent Claim 23 words
A lead according to claim 1 wherein the extension includes means for enhancing the extensions ability to be retained within the epidural space.
Claim 21
Dependent Claim 44 words
A lead according to claim 19 wherein the means for enhancing the extensions ability to be retained within the epidural space include texturing the outer surface of the extension to enhance the frictional contact between the extension and the dura and spinal canal wall.
Claim 22
Dependent Claim 29 words
A lead according to claim 20 wherein the texturing added to the outer surface of the extension includes texturing chosen from the group consisting of dimples, ridges and grooves.
Claim 23
Dependent Claim 46 words
A lead according to claim 19 wherein the means for enhancing the extensions ability to be retained within the epidural space includes adding protrusions to the outer surface of the extension to enhance the frictional contact between the extension and the dura and spinal canal wall.
Claim 24
Independent Claim 107 words
A system for producing parasthesia in a patient comprising: a neurological epidural lead having a proximal end and a distal end, the lead comprising: a body having at least two electrodes attached thereto near the distal end of the lead; a connector attached at the proximal end of the lead; wires connecting the electrodes to the connector; an extension extending distally beyond the most distal electrode, the extension adapted to remain entirely in the epidural space of a spinal column, wherein the length of the extension corresponds to the length of at least one vertebral segment; and an implantable electrical pulse generator electrically connected to the wires.
Claim 25
Independent Claim 107 words
A system for producing parasthesia in a patient comprising: a neurological epidural lead having a proximal end and a distal end, the lead comprising: a body having at least two electrodes attached thereto near the distal end of the lead; a connector attached at the proximal end of the lead; wires connecting the electrodes to the connector; an extension extending distally beyond the most distal electrode, the extension adapted to remain entirely in the epidural space of a spinal column, wherein the length of the extension corresponds to the length of at least one vertebral segment; and an implantable electrical pulse generator electrically connected to the wires.
Claim 26
Independent Claim 244 words
A method for anchoring a neurological epidural lead in the epidural space of a patient, the method comprising the steps of: providing a lead having a proximal end and a distal end, the lead having a body with at least two electrodes attached thereto near the distal end of the lead, a connector attached at the proximal end of the lead, wires connecting the electrodes to the connector and an extension extending distally beyond the most distal electrode for a distance corresponding to the length of at least one vertebral segment, the extension adapted to remain entirely in the epidural space of a spinal column; inserting the lead into a needle having a proximal and a patient contacting distal end, the extension being coterminous with the distal end of the needle; inserting the needle into a spinal column through a spinal canal wall; puncturing the ligamentum flavum with the needle to produce a small opening into the epidural space; pushing the lead out of the needle upward in the epidural space until the electrodes are in the desired location and the extension passes through at least one location in the epidural space where the dura and the spinal canal wall are in contact and wherein the distal end of the lead is retained entirely within the epidural space; removing the needle; whereby contact between the extension and the dura and spinal canal wall hold the extension in a fixed relation within the epidural space.
Claim 27
Independent Claim 244 words
A method for anchoring a neurological epidural lead in the epidural space of a patient, the method comprising the steps of: providing a lead having a proximal end and a distal end, the lead having a body with at least two electrodes attached thereto near the distal end of the lead, a connector attached at the proximal end of the lead, wires connecting the electrodes to the connector and an extension extending distally beyond the most distal electrode for a distance corresponding to the length of at least one vertebral segment, the extension adapted to remain entirely in the epidural space of a spinal column; inserting the lead into a needle having a proximal and a patient contacting distal end, the extension being coterminous with the distal end of the needle; inserting the needle into a spinal column through a spinal canal wall; puncturing the ligamentum flavum with the needle to produce a small opening into the epidural space; pushing the lead out of the needle upward in the epidural space until the electrodes are in the desired location and the extension passes through at least one location in the epidural space where the dura and the spinal canal wall are in contact and wherein the distal end of the lead is retained entirely within the epidural space; removing the needle; whereby contact between the extension and the dura and spinal canal wall hold the extension in a fixed relation within the epidural space.
Claim 28
Dependent Claim 28 words
The method of claim 24 further comprising the step of anchoring the proximal end of the lead outside the spinal column to prevent axial movement of the lead.
Claim 29
Dependent Claim 34 words
A method according to claim 24 wherein the step of providing a lead includes the step of providing a lead having means for enhancing the extension's ability to be retained within the epidural space.
Claim 30
Dependent Claim 85 words
A neurological epidural lead having a proximal end and a distal end, the lead comprising: a body having at least two electrodes attached thereto near the distal end of the lead; a connector attached at the proximal end of the lead; wires connecting the electrodes to the connector; an extension extending distally beyond the most distal electrode, the extension adapted to remain entirely within the epidural space of a spinal column, wherein the length of the extension is approximately 9 to 90 millimeters in length.
Claim 31
Dependent Claim 85 words
A neurological epidural lead having a proximal end and a distal end, the lead comprising: a body having at least two electrodes attached thereto near the distal end of the lead; a connector attached at the proximal end of the lead; wires connecting the electrodes to the connector; an extension extending distally beyond the most distal electrode, the extension adapted to remain entirely within the epidural space of a spinal column, wherein the length of the extension is approximately 9 to 90 millimeters in length.
Claim 32
Dependent Claim 20 words
A lead according to claim 27 wherein the length of the extension is approximately 15 to 30 millimeters in length.
Claim 33
Dependent Claim 20 words
A lead according to claim 27 wherein the length of the extension is approximately 9 to 45 millimeters in length.
Claim 34
Dependent Claim 23 words
A lead according to claim 27 wherein the extension includes means for enhancing the extensions ability to be retained within the epidural space.
Claim 35
Independent Claim 240 words
A method for anchoring a neurological epidural lead in the epidural space of a patient, the method comprising the steps of: providing a lead having a proximal end and a distal end, the lead having a body with at least two electrodes attached thereto near the distal end of the lead, a connector attached at the proximal end of the lead, wires connecting the electrodes to the connector and an extension extending distally beyond the most distal electrode for a distance of approximately 9 to 90 millimeters, the extension adapted to remain entirely in the epidural space of a spinal column; inserting the lead into a needle having a proximal and a patient contacting distal end, the extension being coterminous with the distal end of the needle; inserting the needle into a spinal column through a spinal canal wall; puncturing the ligamentum flavum with the needle to produce a small opening into the epidural space; pushing the lead out of the needle upward in the epidural space until the electrodes are in the desired location and the extension passes through at least one location in the epidural space where the dura and the spinal canal wall are in contact and wherein the distal end of the lead is retained entirely within the epidural space; removing the needle; whereby contact between the extension and the dura and spinal canal wall hold the extension in a fixed relation within the epidural space.
Claim 36
Independent Claim 240 words
A method for anchoring a neurological epidural lead in the epidural space of a patient, the method comprising the steps of: providing a lead having a proximal end and a distal end, the lead having a body with at least two electrodes attached thereto near the distal end of the lead, a connector attached at the proximal end of the lead, wires connecting the electrodes to the connector and an extension extending distally beyond the most distal electrode for a distance of approximately 9 to 90 millimeters, the extension adapted to remain entirely in the epidural space of a spinal column; inserting the lead into a needle having a proximal and a patient contacting distal end, the extension being coterminous with the distal end of the needle; inserting the needle into a spinal column through a spinal canal wall; puncturing the ligamentum flavum with the needle to produce a small opening into the epidural space; pushing the lead out of the needle upward in the epidural space until the electrodes are in the desired location and the extension passes through at least one location in the epidural space where the dura and the spinal canal wall are in contact and wherein the distal end of the lead is retained entirely within the epidural space; removing the needle; whereby contact between the extension and the dura and spinal canal wall hold the extension in a fixed relation within the epidural space.
Claim 37
Dependent Claim 34 words
A method according to claim 31 wherein the step of providing a lead includes the step of providing a lead having means for enhancing the extension's ability to be retained within the epidural space.

References Cited (Backward Citations)

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USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2001-03-30 2001-09-29 2002-03-31 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2005-03-30 2005-09-29 2006-03-31 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2009-03-30 2009-09-29 2010-03-31 $7700.00 Window Closed / Lapsed

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