WO2016035218A1 - Gaine pour débridement de fil de stimulateur cardiaque - Google Patents

Gaine pour débridement de fil de stimulateur cardiaque Download PDF

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Publication number
WO2016035218A1
WO2016035218A1 PCT/JP2014/075756 JP2014075756W WO2016035218A1 WO 2016035218 A1 WO2016035218 A1 WO 2016035218A1 JP 2014075756 W JP2014075756 W JP 2014075756W WO 2016035218 A1 WO2016035218 A1 WO 2016035218A1
Authority
WO
WIPO (PCT)
Prior art keywords
metal wire
lead
pacemaker lead
sheath
adhesion
Prior art date
Application number
PCT/JP2014/075756
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English (en)
Japanese (ja)
Inventor
嗣允 藤原
Original Assignee
嗣允 藤原
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 嗣允 藤原 filed Critical 嗣允 藤原
Publication of WO2016035218A1 publication Critical patent/WO2016035218A1/fr

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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
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • 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

Definitions

  • the present invention relates to a pacemaker lead adhesion peeling sheath capable of relatively easily peeling the adhesion tissue along the pacemaker lead when the pacemaker lead adheres in vivo.
  • pacemaker implantation for bradyarrhythmia implantation of an implantable cardioverter defibrillator to prevent sudden cardiac death due to lethal ventricular arrhythmia
  • pacemaker implantation for cardiac resynchronization therapy in patients with severe heart failure etc.
  • Type electrical device therapy has become widespread.
  • a pacemaker lead also referred to simply as a “lead” that delivers the electrical signal of the electrical device body to the heart is placed in the body by surgery together with the electrical device body.
  • the electrical device body or pacemaker lead placed in the body sometimes needs to be removed from the body due to infection, increased threshold due to prolonged placement, disconnection of the pacemaker lead, movement of these positions, etc. There is.
  • a problem in removing the lead from the body is the adhesion of living tissue to the pacemaker lead.
  • the present inventor has so far developed, for example, a “lead extraction method with grasping forceps” as proposed in Non-Patent Documents 1 and 2 below, and this method has been called a so-called Fujiwara Method. .
  • Fujiwara Method is a method in which an aluminum tube is pushed over a lead and the adhesion is peeled off at the tip of the aluminum tube.
  • this method is sufficiently applicable in the range from the subclavian vein to the superior vena cava, it cannot be applied in the range from the right atrium to the right ventricle. This is because the aluminum tube cannot be advanced along the bending of the lead because the aluminum tube has no elasticity (flexibility).
  • an excimer laser intracardiac lead extraction system uses a laser to separate the adhesion part and peel it off.
  • this is a system in which a catheter Y that irradiates a laser beam X from the tip is inserted over a lead L, and the adhesion portion is separated with a laser.
  • the perforation Z of the superior vena cava or the right atrium may occur as a risk when the site to be cut off becomes large depending on the direction of laser irradiation and the state of the adhesion tissue T.
  • the present invention has been proposed in view of the above circumstances, and is a creation based on the successful development of an elastic (flexible) device in place of the aluminum tube of the “lead extraction method with grasping forceps”.
  • the present invention makes it relatively easy for the pacemaker lead to adhere to the pacemaker lead along the pacemaker lead under X-ray transmission due to its flexibility even when the pacemaker lead adheres in vivo, even in the range from the right atrium to the right ventricle. It is an object of the present invention to provide a pacemaker lead adhesion peeling sheath that can be peeled.
  • the present invention is a pacemaker lead adhesion peeling sheath in which a thin metal wire is wound in a predetermined direction to form a spiral, and this spiral forms a flexible tube shape.
  • a gap is formed between the first and second windings of the metal wire that forms the spiral, and one end of the metal wire that is the tip of the first winding has a sharp edge shape.
  • a handle portion is provided on the other end side of the metal wire.
  • the pacemaker lead adhesion peeling sheath according to the present invention is characterized in that its surface and inner surface are coated.
  • the sheath for pacemaker lead adhesion peeling according to the present invention has a configuration in which a thin metal wire is wound in a predetermined direction to form a spiral, and this spiral forms a flexible tube shape. Therefore, the flexible tube shape can be pushed in along the bent movement of the pacemaker lead even in the range from the superior vena cava to the tip (for example, from the right atrium to the right ventricle). Can be peeled from the lead. Furthermore, in the present invention, a gap is formed between the first and second windings of the metal wire forming a spiral, and the end of the first winding of the metal wire has a sharp edge shape. Structure.
  • the tip of the blade-like shape is stabbed into the adhesion tissue, and the present invention is rotated in a predetermined direction (for example, clockwise) to put the adhesion tissue in the gap between the first and second rolls and to detach it.
  • a predetermined direction for example, clockwise
  • the handle portion is provided on the other end side of the metal wire, it can be rotated while being pushed in, and this pushing and rotating force can be efficiently transmitted to the blade shape at the tip, so that the adhesion tissue can be transferred.
  • the cutting operation can be easily achieved.
  • the sheath for pacemaker lead adhesion peeling according to the present invention has a structure in which the surface (the surface in contact with the surrounding tissue) and the inner surface (the inner surface in contact with the lead) are coated, thereby preventing metal allergy, etc. It becomes possible to apply also to the patient who has, and the tube-shaped surface and inner surface of a metal wire can be smoothed.
  • the friction between the pacemaker lead adhesion peeling sheath, the adhesion tissue, and the lead is reduced.
  • the range of the coating can be changed as required. For example, it is possible to propose a form in which the other portion except the 5 mm tip is covered.
  • FIG. 1 is a schematic front view of a pacemaker lead adhesion peeling sheath according to the present invention.
  • FIG. 2 is an enlarged explanatory view illustrating the one end side of the pacemaker lead adhesion peeling sheath according to the present invention in an enlarged manner so as to include the first and second windings of the metal wire forming the spiral.
  • FIG. 3 is an enlarged explanatory view illustrating the other end side of the pacemaker lead adhesion peeling sheath according to the present invention in an enlarged manner so as to include a handle portion.
  • FIG. 4 is an explanatory diagram for explaining a use state of the pacemaker lead adhesion peeling sheath according to the present invention.
  • FIG. 5 is a schematic view for schematically explaining the adhesion peeling of the pacemaker lead by the excimer laser intracardiac lead extraction system.
  • the pacemaker lead adhesion peeling sheath according to the present invention forms a spiral by winding a thin metal wire 1 in a predetermined direction, for example, clockwise in the traveling direction. Is formed into a flexible tube shape. A space is provided between the first and second turns of the metal wire 1 forming a spiral, and a gap S is formed (see FIG. 2).
  • One end of the metal wire 1, which is the tip of the first winding, has a sharp blade-like protrusion 11, and the other end of the metal wire 1 has a handle portion 12.
  • the surface and the inner surface of the pacemaker lead adhesion peeling sheath that is, the tubular surface and the inner surface of the metal wire 1 are coated with a resin or the like of a material for preventing metal allergy.
  • a resin or the like of a material for preventing metal allergy is silicon.
  • the thickness of the coating may be 0.1 to 0.5 mm, for example, 0.2 mm.
  • the thin metal wire 1 can be made of stainless steel, for example. However, other metals may be used. As shown in FIG.
  • the spiral forming the tube shape is formed in a dense state where no gap is recognized as a whole, but as shown in FIG.
  • a gap of 0.6 to 1.0 mm width is provided to form a gap S.
  • the size of the gap S corresponds to the size of one or two lines of the metal wire 1.
  • the wire diameter of the metal wire 1 can also be appropriately adjusted according to the purpose.
  • the pacemaker lead adhesion peeling sheath according to the present invention has a sharp blade-like projection 11 at one end of the metal wire 1 which is the tip of the first winding.
  • the protrusion 11 is a blade having a size of 0.4 to 0.6 mm, for example, 0.5 mm.
  • the other end side of the metal wire 1 is provided with a cylindrical handle portion 12 as shown in FIG.
  • the handle portion 12 serves as an operation portion for a practitioner performing a lead adhesion peeling operation to operate the pacemaker lead adhesion peeling sheath with a fingertip or the like when using the sheath for pacemaker lead adhesion peeling according to the present invention.
  • the practitioner pushes the handle 12 while turning it clockwise, thereby transmitting the pushing and rotating force to the blade-like protrusion 11 which is one end of the metal wire 1.
  • the adhesion tissue can be separated from the lead.
  • the handle portion 12 may have any shape that can be operated with a fingertip, such as a plate shape, in addition to the cylindrical shape shown in FIG.
  • the material can be made of plastic or metal.
  • the pacemaker lead adhesion peeling sheath according to the present invention can be configured with variations as described in [Table 1] below.
  • various types of variations are prepared to promote adhesion peeling using an appropriate pacemaker lead adhesion peeling sheath according to the degree of adhesion progression, lead thickness, length, etc. be able to.
  • a method of using the sheath for pacemaker lead adhesion peeling according to the present invention used in surgery will be briefly described with reference to FIG.
  • the sheath for pacemaker lead adhesion peeling according to the present invention is used, for example, while confirming its state together with the pacemaker lead under fluoroscopy. First, as shown in FIG.
  • the sheath for pacemaker lead adhesion peeling according to the present invention is put on the lead L, and inserted into the right ventricle from the subclavian vein in this state. Since the lead L bends when the tip of the pacemaker lead adhesion peeling sheath contacts the adhesion tissue, the pacemaker lead adhesion peeling sheath is pushed in and rotated while pulling back the lead L, and the adhesion tissue around the lead L is peeled off. . Specifically, the blade-shaped protrusion 11 at one end of the metal wire 1 is pierced into the adhesion tissue, and rotated clockwise to put the adhesion tissue into the gap S between the first and second rolls and cut it off. It is.
  • the thin metal wire 1 is wound clockwise to form a spiral, and the spiral is formed into a flexible tube shape. Therefore, if the lead L is bent, the wire is bent along it. It will be. For this reason, the pacemaker lead adhesion peeling sheath can be pushed and rotated also in the bent portion of the lead L, and the force of pushing and rotation is transmitted to the blade of the projection 11 at the tip, and the adhesion around the lead L is adhered.
  • tissue can be put in the clearance gap S between the 1st roll and the 2nd roll, and can be peeled easily.
  • the pacemaker lead adhesion peeling sheath is pulled out from the subclavian vein to the outside. Subsequently, by pulling the lead L, the lead L can be pulled out of the body. Even if adhesion is strong at the tip of the lead L, such as the electrode, and it is difficult to remove, if the lead L is picked and pulled by the forceps inserted from the right femoral vein, the lead L is removed from the body. It becomes possible to do.
  • the pacemaker lead adhesion peeling sheath has a structure in which a thin metal wire 1 is wound clockwise to form a spiral, and a flexible tube shape is formed by the spiral.
  • the present invention can be pushed and rotated along the curved or bent travel of the lead L even in the range from the superior vena cava to the right atrium to the right ventricle due to the flexible tube shape.
  • the living tissue can be detached from the lead L.
  • a gap S is formed between the first and second turns of the spirally formed metal wire 1 and has a blade-like protrusion 11 with one end of the metal wire 1 that is the tip of the first turn sharpened. Structure.
  • the blade-shaped protrusion 11 is pierced into the adhesion tissue and rotated clockwise to put the adhesion tissue into the gap S between the first and second rolls and to separate it. Further, by providing the handle portion 12 on the other end side of the metal wire 1, the handle portion 12 can be rotated while being pushed in, and the force of the pushing and rotation can be efficiently transmitted to the protrusion 11 to cut the adhesion tissue. Operation can be achieved easily. Moreover, since the exfoliation of the adhesion tissue is promoted while confirming the state of the pacemaker lead adhesion exfoliation sheath and the lead L according to the present invention under X-ray fluoroscopy, it is possible to prevent the tissue other than the adhesion tissue from being damaged.
  • the present invention is not limited to this embodiment, and various designs can be made without departing from the matters described in the claims of the utility model registration. It is possible to make changes.
  • the example in which the spiral of the metal wire is wound is described as being clockwise along the traveling direction. This is a tool that is easy to operate for a practitioner whose right hand is right. This is an example of the configuration adopted for this purpose. Therefore, it is also possible to construct the present invention by winding a spiral counterclockwise along the traveling direction for a practitioner whose dominant hand is left.
  • this invention is made into the spiral form in order to give elasticity, it does not necessarily need to be limited to a uniform number of turns.
  • the number of turns of several centimeters from the tip may be configured to be smaller than the number of turns of other portions.
  • the elasticity of a portion of several centimeters from the tip is stronger than the other portions, and as a result, it is easy to pass through the bent portion of the lead having a strong bend.
  • members, parts, and the like necessary for constituting the present invention may employ members, parts, etc. other than those exemplified as long as they satisfy the functions and effects that can be obtained from the present invention. Can do.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)

Abstract

La présente invention a pour but de séparer un tissu adhérant le long de la courbe d'un fil de stimulateur cardiaque. Cette gaine pour le débridement du fil de stimulateur cardiaque est configurée avec un fil métallique de petit diamètre (1) enroulé en spirale, dans le sens des aiguilles d'une montre, et en forme de tube ayant une flexibilité due à la spirale, le fil métallique (1) étant revêtu d'une résine synthétique, etc., de façon à pouvoir prévenir une allergie à un métal, etc. Cette gaine pour débridement du fil de stimulateur cardiaque est structurée de telle sorte qu'un espace (S) est formé entre un premier tour et un second tour du fil métallique (1) formant la spirale, une première extrémité du fil métallique (1), qui est la pointe du premier tour, étant une saillie en forme de lame pointue (11), et une partie poignée (12) est située sur l'autre extrémité du fil métallique (1). Un médecin tourne la partie poignée (12), dans le sens des aiguilles d'une montre, avec le bout de ses doigts et pousse dans la gaine pour transmettre la force de celle-ci à la saillie en forme de lame pointue (11), qui est la première extrémité du fil métallique (1), et sépare un tissu adhérant du fil de stimulateur cardiaque avec la lame de la saillie (11).
PCT/JP2014/075756 2014-09-02 2014-09-17 Gaine pour débridement de fil de stimulateur cardiaque WO2016035218A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2014004660U JP3194755U (ja) 2014-09-02 2014-09-02 ペースメーカーリード癒着剥離用シース
JP2014-004660 2014-09-02

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WO2016035218A1 true WO2016035218A1 (fr) 2016-03-10

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022502130A (ja) * 2018-09-25 2022-01-11 コーニンクレッカ フィリップス エヌ ヴェKoninklijke Philips N.V. 植え込みリード抜去のための画像ガイダンス

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH02180248A (ja) * 1988-11-09 1990-07-13 Medical Eng & Dev Inst Inc 細長体除去装置とその方法
JPH09503408A (ja) * 1993-10-01 1997-04-08 メドトロニック・インコーポレーテッド 植え込まれた物体を除去するためのレーザー装置
US5779715A (en) * 1997-07-28 1998-07-14 Irvine Biomedical, Inc. Lead extraction system and methods thereof
US5980515A (en) * 1997-12-19 1999-11-09 Irvine Biomedical, Inc. Devices and methods for lead extraction
JP2000152999A (ja) * 1998-11-18 2000-06-06 Cardio Pacing Research Laboratory:Kk 抜去用シース及びリード抜去システム
JP2008155033A (ja) * 2006-12-22 2008-07-10 Spectranetics Corp 組織分離のシステムと方法
JP2008536577A (ja) * 2005-04-15 2008-09-11 クック バスキュラー インコーポレイテッド リード線摘出装置
JP2012515011A (ja) * 2009-01-13 2012-07-05 リーデックス カーディアック リミテッド リード線を抜去する方法および装置
JP2014513618A (ja) * 2011-04-01 2014-06-05 リーデックス カーディアック リミテッド リード線摘出方法及び装置
JP2014117619A (ja) * 2012-12-17 2014-06-30 Cook Medical Technologies Llc 植え込まれた医療機器を抜去できるように準備するための装置

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH02180248A (ja) * 1988-11-09 1990-07-13 Medical Eng & Dev Inst Inc 細長体除去装置とその方法
JPH09503408A (ja) * 1993-10-01 1997-04-08 メドトロニック・インコーポレーテッド 植え込まれた物体を除去するためのレーザー装置
US5779715A (en) * 1997-07-28 1998-07-14 Irvine Biomedical, Inc. Lead extraction system and methods thereof
US5980515A (en) * 1997-12-19 1999-11-09 Irvine Biomedical, Inc. Devices and methods for lead extraction
JP2000152999A (ja) * 1998-11-18 2000-06-06 Cardio Pacing Research Laboratory:Kk 抜去用シース及びリード抜去システム
JP2008536577A (ja) * 2005-04-15 2008-09-11 クック バスキュラー インコーポレイテッド リード線摘出装置
JP2008155033A (ja) * 2006-12-22 2008-07-10 Spectranetics Corp 組織分離のシステムと方法
JP2012515011A (ja) * 2009-01-13 2012-07-05 リーデックス カーディアック リミテッド リード線を抜去する方法および装置
JP2014513618A (ja) * 2011-04-01 2014-06-05 リーデックス カーディアック リミテッド リード線摘出方法及び装置
JP2014117619A (ja) * 2012-12-17 2014-06-30 Cook Medical Technologies Llc 植え込まれた医療機器を抜去できるように準備するための装置

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022502130A (ja) * 2018-09-25 2022-01-11 コーニンクレッカ フィリップス エヌ ヴェKoninklijke Philips N.V. 植え込みリード抜去のための画像ガイダンス
JP7366127B2 (ja) 2018-09-25 2023-10-20 コーニンクレッカ フィリップス エヌ ヴェ 植え込みリード抜去のための画像ガイダンス

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