JP6072986B2 - セグメント電極を備えたリード並びにリードの製造及び使用方法 - Google Patents
セグメント電極を備えたリード並びにリードの製造及び使用方法 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0526—Head electrodes
- A61N1/0529—Electrodes for brain stimulation
- A61N1/0534—Electrodes for deep brain stimulation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/12—Manufacturing methods specially adapted for producing sensors for in-vivo measurements
- A61B2562/125—Manufacturing methods specially adapted for producing sensors for in-vivo measurements characterised by the manufacture of electrodes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0102—Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0551—Spinal or peripheral nerve electrodes
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49002—Electrical device making
- Y10T29/49117—Conductor or circuit manufacturing
- Y10T29/49174—Assembling terminal to elongated conductor
- Y10T29/49176—Assembling terminal to elongated conductor with molding of electrically insulating material
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- Neurology (AREA)
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- Psychology (AREA)
- Cardiology (AREA)
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- Radiology & Medical Imaging (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
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- Electrotherapy Devices (AREA)
Description
本出願は、2013年7月12日に出願された米国仮特許出願第61/845,739号の合衆国法典第35編第119条(e)に基づく利益を主張するものであり、この米国仮特許出願を本明細書に援用する。
Claims (20)
- 刺激リードを作成する方法であって、
少なくとも1つのプレ電極をリード本体の遠位端部分に沿って配置するステップを含み、前記少なくとも1つのプレ電極は、プレ電極本体を含み、前記プレ電極本体は、近位端部と、遠位端部と、導電性の中心ハブと、前記中心ハブに個別に結合され且つ前記中心ハブから半径方向外向きに延びる複数の導電性刺激部材とを有し、前記複数の導電性刺激部材の各々は、残りの前記複数の導電性刺激部材の各々に前記中心ハブのみを介して電気的に結合され、
更に、前記リード本体の近位端部分に沿って配置された複数の端子から延びる複数の導体のうちの少なくとも1つの導体を前記複数の刺激部材の各々に電気的に結合させるステップと、
非導電性材料を前記中心ハブの長手方向面の周囲に配置して、前記非導電性材料を前記複数の導電性刺激部材の内面に当接させるステップと、
前記中心ハブを前記プレ電極本体から除去して前記複数の導電性刺激部材の各々を互いに電気的に絶縁し、それにより、前記複数の導電性刺激部材を、前記非導電性材料に沿って配置され且つ電気的に絶縁された複数のセグメント電極に変換するステップと、を含む方法。 - 前記少なくとも1つのプレ電極を前記リード本体の遠位端部分に沿って配置する前記ステップは、前記複数の導電性刺激部材を前記中心ハブに電気的に結合させる複数の連結要素を含む少なくとも1つのプレ電極を、前記リード本体の遠位端部分に沿って配置するステップを含む、請求項1に記載の方法。
- 前記少なくとも1つのプレ電極を前記リード本体の遠位端部分に沿って配置する前記ステップは、正確に3つの導電性刺激部材を含む少なくとも1つのプレ電極を、前記リード本体の遠位端部分に沿って配置するステップを含む、請求項1に記載の方法。
- 前記中心ハブを除去して前記複数の導電性刺激部材の各々を互いに電気的に絶縁する前記ステップは、前記中心ハブを含む前記リード本体の一部に沿ってドリルを通過させて、前記リード本体の少なくとも一部に沿う中心内腔を構成し、前記中心ハブを除去し且つ前記複数の連結要素間の連結部を切除するステップを含む、請求項1に記載の方法。
- 更に、絶縁材料を前記中心内腔の壁に沿って配置し、前記セグメント電極を前記中心内腔から電気的に絶縁させるステップを含む、請求項1に記載の方法。
- 絶縁材料を前記中心内腔の壁に沿って配置する前記ステップは、非導電性チューブ材を前記中心内腔の壁に沿ってリフロー処理するステップを含む、請求項5に記載の方法。
- 絶縁材料を前記中心内腔の壁に沿って配置する前記ステップは、化学蒸着法を用いて、非導電性材料を前記中心内腔の壁に沿って堆積させるステップを含む、請求項5に記載の方法。
- 絶縁材料を前記中心内腔の壁に沿って配置する前記ステップは、非導電性材料を前記中心内腔の壁に沿って射出成形するステップを含む、請求項5に記載の方法。
- 前記非導電性材料を前記中心ハブの長手方向面の周囲に配置して、前記非導電性材料を前記複数の導電性刺激部材の内面に当接させる前記ステップは、非導電性材料を前記中心ハブの長手方向面の周囲に配置して、前記非導電性材料を前記複数の導電性刺激部材の外面に面一にするステップを含む、請求項1に記載の方法。
- 刺激リードのためのプレ電極であって、
実質的に円筒形のプレ電極本体を有し、
前記プレ電極本体は、近位端部と、遠位端部と、長手方向面を有する導電性の中心ハブと、前記中心ハブの長手方向面から半径方向外向きに延びる複数の連結要素と、を有し、前記複数の連結要素の各々は、前記中心ハブに結合された内側端部と、その両側の外側端部を有し、
前記プレ電極本体は、更に、複数の刺激部材を有し、前記複数の刺激部材の各々は、内面と、外面を有し、前記複数の刺激部材の各々の内面は、前記複数の連結要素のうちの少なくとも1つの連結要素の内側端部に結合され、前記複数の刺激部材の各々は、前記複数の刺激部材のうちの残りの刺激部材の各々に前記中心ハブのみを介して電気的に結合される、プレ電極。 - 前記中心ハブはチューブ形状である、請求項10に記載のプレ電極。
- 前記複数の刺激部材の各々の内面は、前記複数の連結要素のうちの正確に1つの連結要素の内側端部に結合される、請求項10に記載のプレ電極。
- 刺激リードであって、
リード本体材料によって構成されたリード本体を有し、前記リード本体は、長手方向面と、遠位端部分と、近位端部分と、長手方向長さを含み、
更に、前記リード本体の長手方向長さに沿って延び、且つ、長手方向壁によって境界が定められる中心内腔と、
前記リード本体の前記遠位端部分に且つ前記リード本体と前記中心内腔との間に配置され、且つ、前記リード本体材料と異なる材料である絶縁材料と、
前記リード本体の近位端部分に沿って配置された複数の端子と、
前記リード本体の遠位端部分に沿って配置された複数の電極と、
前記複数の端子を前記複数の電極に電気的に結合させる複数の導体と、を有し、
前記複数の電極は、複数のセグメント電極を含み、前記複数のセグメント電極の各々は、外面及びその反対側の内面を有する刺激部材と、前記刺激部材の内面に結合され且つ前記絶縁材料まで半径方向内向きに延びる連結要素と、を含む刺激リード。 - 前記複数のセグメント電極のうちの少なくとも1つのセグメント電極の刺激部材は、少なくとも1つのリード保持特徴部を含む、請求項13に記載の刺激リード。
- 前記少なくとも1つのリード保持特徴部は、前記少なくとも1つのセグメント電極の刺激部材の内面に沿って配置された少なくとも1つの引掛り部を含む、請求項14に記載の刺激リード。
- 前記少なくとも1つのリード保持特徴部は、前記少なくとも1つのセグメント電極の連結要素に沿って配置された少なくとも1つの引掛り部を含む、請求項14に記載の刺激リード。
- 前記少なくとも1つのリード保持特徴部は、前記少なくとも1つのセグメント電極の刺激部材に沿って設けられた少なくとも1つのアンダーカット部を含む、請求項14に記載の刺激リード。
- 前記複数の電極は、少なくとも1つのリング電極を含む、請求項13に記載の刺激リード。
- 前記複数の電極は、少なくとも1つの先端電極を含む、請求項13に記載の刺激リード。
- 前記刺激部材は、3つの刺激部材を含む、請求項13に記載の刺激リード。
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US201361845739P | 2013-07-12 | 2013-07-12 | |
US61/845,739 | 2013-07-12 | ||
PCT/US2014/045618 WO2015006239A1 (en) | 2013-07-12 | 2014-07-07 | Leads with segmented electrodes and methods of making and using the leads |
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JP2016524960A JP2016524960A (ja) | 2016-08-22 |
JP6072986B2 true JP6072986B2 (ja) | 2017-02-01 |
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US (1) | US9289596B2 (ja) |
EP (1) | EP3019232B1 (ja) |
JP (1) | JP6072986B2 (ja) |
CN (1) | CN105377360A (ja) |
AU (1) | AU2014287516A1 (ja) |
WO (1) | WO2015006239A1 (ja) |
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WO2013067369A1 (en) | 2011-11-02 | 2013-05-10 | Boston Scientific Neuromodulation Corporation | Systems and methods for making improved leads for electrical stimulation systems |
WO2013112905A1 (en) | 2012-01-26 | 2013-08-01 | Boston Scientific Neuromodulation Corporation | Systems and methods for identifying the circumferential positioning of electrodes of leads for electrical stimulation systems |
WO2013148092A1 (en) | 2012-03-30 | 2013-10-03 | Boston Scientific Neuromodulation Corporation | Leads with x-ray fluorescent capsules for electrode identification and methods of manufacture and use |
WO2013162775A2 (en) | 2012-04-27 | 2013-10-31 | Medtronic, Inc. | Structures and techniques for medical lead fabrication |
WO2013177145A1 (en) | 2012-05-25 | 2013-11-28 | Boston Scientific Neuromodulation Corporation | Methods for stimulating the dorsal root ganglion with a lead having segmented electrodes |
EP2854936B1 (en) | 2012-06-01 | 2016-05-25 | Boston Scientific Neuromodulation Corporation | Leads with tip electrode for electrical stimulation systems and methods of making and using |
US9555234B2 (en) | 2012-07-26 | 2017-01-31 | Medtronic, Inc. | Implantable medical leads |
US8897891B2 (en) | 2012-08-03 | 2014-11-25 | Boston Scientific Neuromodulation Corporation | Leads with electrode carrier for segmented electrodes and methods of making and using |
-
2014
- 2014-07-07 JP JP2016525405A patent/JP6072986B2/ja not_active Expired - Fee Related
- 2014-07-07 EP EP14744704.9A patent/EP3019232B1/en active Active
- 2014-07-07 US US14/325,249 patent/US9289596B2/en active Active
- 2014-07-07 WO PCT/US2014/045618 patent/WO2015006239A1/en active Application Filing
- 2014-07-07 AU AU2014287516A patent/AU2014287516A1/en not_active Abandoned
- 2014-07-07 CN CN201480039644.XA patent/CN105377360A/zh active Pending
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WO2015006239A1 (en) | 2015-01-15 |
CN105377360A (zh) | 2016-03-02 |
AU2014287516A1 (en) | 2016-01-21 |
EP3019232A1 (en) | 2016-05-18 |
EP3019232B1 (en) | 2019-08-21 |
JP2016524960A (ja) | 2016-08-22 |
US9289596B2 (en) | 2016-03-22 |
US20150018915A1 (en) | 2015-01-15 |
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