# US 2014/0155968 A1 · Electrical stimulation paddle leads and methods of making and using > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0155968 A1 - Document ID: US20140155968A1 - Status: Published application - Kind: A1 - Application number: 14/091,036 - Filed: 2013-11-26 - Published: 2014-06-05 - Earliest claimed: 2012-12-03 - Assignees: Boston Scientific Neuromodulation Corporation - Applicants: Boston Scientific Neuromodulation Corporation - Inventors: Michael Govea; Jacob B. Leven - Web page: https://patentgrep.com/patent/US20140155968A1 ## CPC - A61N 1/0553: {Paddle shaped electrodes, e.g. for laminotomy} - Y10T 29/49117: Conductor or circuit manufacturing - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract An electrical stimulation lead includes a paddle body, at least one lead body having a distal end, a proximal end, and a longitudinal length with the distal end of the lead body coupled to the paddle body. The lead further includes fixation elements and electrodes. The fixation elements are disposed entirely within the paddle body and the electrodes are disposed on the paddle body. Each of the electrodes includes a stimulating element with an exposed stimulation surface, and a piercing element extending from the stimulating element into the paddle body and making contact with at least one of the fixation elements. Further, the lead includes terminals disposed along the proximal end of the lead body and conductor wires electrically coupling the electrodes to the terminals. In addition, methods of making stimulation leads using sacrificial portions of electrodes are presented. ## Claims ### Claim 1 An electrical stimulation lead, comprising: a paddle body; at least one lead body having a distal end, a proximal end, and a longitudinal length, the distal end of each of the at least one lead bodies coupled to the paddle body; a plurality of fixation elements disposed entirely within the paddle body; a plurality of electrodes disposed on the paddle body, each electrode comprising a stimulating element with an exposed stimulation surface and a piercing element extending from the stimulating element into the paddle body and making contact with at least one of the plurality of fixation elements; a plurality of terminals disposed along the proximal ends of each of the at least one lead bodies; and a plurality of conductor wires, each conductor wire of the plurality of conductor wires electrically coupling each of the plurality of terminals to at least one of the plurality of electrodes. ### Claim 2 (depends on 1) The electrical stimulation lead of claim 1, wherein each of the plurality of electrodes comprises a first locking arrangement and each of the plurality of fixation elements comprises a second locking arrangement and wherein the first and second locking arrangements are configured and arranged, when engaged with each other, to lock a one of the electrodes to a one of the fixation elements. ### Claim 3 (depends on 2) The electrical stimulation lead of claim 2, wherein a one of the first and second locking arrangements comprises a ridge and another one of the first and second locking arrangements comprises a detent configured and arranged to receive the ridge. ### Claim 4 (depends on 2) The electrical stimulation lead of claim 2, wherein a one of the first and second locking arrangements comprises a locking ridge and another one of the first and second locking arrangements comprises a spring element configured and arranged to allow the ridge to pass over the spring element and to hinder reversing passage of the ridge over the spring element. ### Claim 5 (depends on 2) The electrical stimulation lead of claim 2, wherein a one of the first and second locking arrangements comprises a threading and another one of the first and second locking arrangements comprises a groove configured and arranged to receive the threading. ### Claim 6 (depends on 1) The electrical stimulation lead of claim 1, wherein each of the plurality of electrodes comprises a first fitting arrangement and each of the plurality of fixation elements comprises a second fitting arrangement and wherein the first and second fitting arrangements are configured and arranged, when engaged with each other, to form a friction fit between a one of the electrodes to a one of the fixation elements to facilitate maintaining contact therebetween. ### Claim 7 (depends on 1) The electrical stimulation lead of claim 1, wherein the piercing element comprises a sharpened distal tip. ### Claim 8 (depends on 1) The electrical stimulation lead of claim 1, wherein each of the conductor wires is physically attached to at least one of the plurality of fixation elements. ### Claim 9 (depends on 1) The electrical stimulation lead of claim 1 wherein the piercing element of each electrode extends into and entirely through at least one of the fixation elements. ### Claim 10 (depends on 1) A method of making the electrical stimulation lead of claim 1, the method comprising: coupling at least one of the plurality of conductive wires to each of the plurality of fixation elements; forming the paddle body around the plurality of fixation elements; and pressing the piercing element of each of the plurality of electrodes into the paddle body and into electrical contact with at least one of the plurality of fixation elements. ### Claim 11 (depends on 1) A method of making the electrical stimulation lead of claim 1, the method comprising: pressing the piercing element of each of the plurality of electrodes through a first portion of the paddle body, the first portion of the paddle body having a front surface and a back surface with the stimulation element of each of the electrodes disposed on the front surface; attaching at least one of the plurality of fixation elements to each of the plurality of electrodes with the fixation elements disposed on the back surface of the first portion of the paddle body; coupling at least one of the plurality of conductive wires to each of the plurality of fixation elements or electrodes; and forming a second portion of the paddle body around the plurality of fixation elements and at least partially beneath the first portion of the paddle body. ### Claim 12 A method of making an electrical stimulation lead, the method comprising: pressing a plurality of electrodes into a first portion of a paddle body that is disposed on a base, each of the electrodes comprising a stimulating portion having a stimulating surface that is exposed when the lead is completed and a plurality of legs extending from the stimulating portion and configured and arranged to be pressed into the first portion of the paddle body; engaging a distal portion of each of the plurality of legs with the base to bend the distal portion at least partially back into the first portion of the paddle body; coupling a plurality of conductor wires to the plurality of electrodes; and forming a second portion of the paddle body at least partially beneath the first portion of the paddle body leaving the stimulating surfaces of the electrodes exposed and covering the legs of the electrodes and a portion of each of the plurality of conductor wires adjacent the electrodes. ### Claim 13 (depends on 12) The method of claim 12, further comprising removing part of the first portion of the paddle body to expose a bottom surface of the stimulation portion of each of the plurality of electrodes, wherein coupling the plurality of conductor wires comprises attached at least one of the conductor wires to the bottom surface of the stimulation portion of the each of the plurality of electrodes. ### Claim 14 (depends on 12) The method of claim 12, wherein forming a second portion of the paddle body comprises attaching the second portion of the paddle body to the first portion of the paddle body using adhesive. ### Claim 15 (depends on 12) The method of claim 12, wherein forming a second portion of the paddle body comprises placing the first portion of the paddle body into a mold and molding the second portion of the paddle body to the first portion of the paddle body. ### Claim 16 A method of making an electrical stimulation lead, the method comprising: disposing a plurality of electrodes into a mold, each of the electrodes comprising a stimulating portion having a stimulating surface that is exposed when the lead is completed, at least one leg portion extending from the stimulating portion opposite the stimulating surface, and at least one sacrificial portion disposed around the periphery of the stimulating surface extending from the stimulating surface in a direction opposite the at least one leg portion, wherein the at least one sacrificial portion of each electrodes is disposed against a surface of the mold; coupling a plurality of conductor wires to the plurality of electrodes; molding a paddle body around the leg portions of the electrodes and portions of the conductor wires adjacent the electrodes, wherein the at least one sacrificial portion disposed against the mold resists flowing of material from the first portion of the paddle body over the stimulating surfaces of the electrodes; and removing the sacrificial portions of the electrodes. ### Claim 17 (depends on 16) The method of claim 16, wherein molding the paddle body comprises molding a first portion of the paddle body between the leg portions of adjacent electrodes, wherein the disposing of the at least one sacrificial portion against the mold resists flowing of material from the first portion of the paddle body over the stimulating surfaces of the electrodes; and molding a second portion of the paddle body at least partially over the first portion of the paddle body leaving the stimulating surfaces of the electrodes exposed and covering the leg portions of the electrodes and the portion of each of the plurality of conductor wires adjacent the electrodes. ### Claim 18 (depends on 17) The method of claim 17, wherein coupling the plurality of conductive wires to the plurality of electrodes occurs after molding the first portion of the paddle body and prior to molding the second portion of the paddle body. ### Claim 19 (depends on 17) The method of claim 17, wherein removing the sacrificial portions of the electrodes occurs after molding the first portion of the paddle body and prior to molding the second portion of the paddle body. ### Claim 20 (depends on 16) The method of claim 16, wherein the at least one sacrificial portion of the stimulating surface of each of the electrodes form an oblique angle.