WO2009106907A1 - Dispositif de fermeture d'appendice auriculaire gauche - Google Patents

Dispositif de fermeture d'appendice auriculaire gauche Download PDF

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Publication number
WO2009106907A1
WO2009106907A1 PCT/IB2008/000430 IB2008000430W WO2009106907A1 WO 2009106907 A1 WO2009106907 A1 WO 2009106907A1 IB 2008000430 W IB2008000430 W IB 2008000430W WO 2009106907 A1 WO2009106907 A1 WO 2009106907A1
Authority
WO
WIPO (PCT)
Prior art keywords
elastic band
appendage
band
annular elastic
annular
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/IB2008/000430
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English (en)
Inventor
Afksendiyos Kalangos
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SEGECO HOLDING SA
Original Assignee
SEGECO HOLDING SA
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 SEGECO HOLDING SA filed Critical SEGECO HOLDING SA
Priority to PCT/IB2008/000430 priority Critical patent/WO2009106907A1/fr
Publication of WO2009106907A1 publication Critical patent/WO2009106907A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12009—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
    • A61B17/12013—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot for use in minimally invasive surgery, e.g. endoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac

Definitions

  • the present invention relates to a left atrial appendage closure device for the heart.
  • the left atrial appendage is a potential site for formation of blood clots in patients suffering of atrial fibrillation, a common form of cardiac arrhythmia.
  • Left atrial appendage also known as “left atrial auricle” is a closed appendage, similar to a small pocket, which opens on the left atrium of the heart.
  • Atrial fibrillation is an atria based arrhythmia characterized by a complete electrical irregularity of activation of the auricles, namely two of the four heart chambers, which means that the normal atrial contractions are replaced by chaotic movements completely ineffective for the propulsion of blood.
  • LAA left atrial appendage
  • Medical science has proposed several methodologies to overcome this problem, some of those are pharmacological methods (eg with anticoagulants), other are surgical methods.
  • the principle underlying the surgical methods consists in closing the left atrial appendage.
  • the first category (the most common) is done with open chest by the surgeon during concomitant heart surgery
  • a second category that provides for the introduction in the heart, inside the appendage, of a device that closes the appendage as a sort of " cap ", which filters or block the blood into or out of appendage
  • a third category where the appendage is closed by operating outside from it, with closed chest.
  • the present invention belongs to the latter category, in which the left atrial appendage is closed by acting from outside, so that it has the advantage of avoiding entering inside of the heart during the surgical operation, thus leading to a minimal invasive approach.
  • a first problem is that, during the rhythmic movement of pulse of the heart, the tissue of appendage which is in contact with the surgical wire, (not elastic), is under tension due to the inability of the tissue to move, following the cardiac pulsations; this situation may in some cases cause lesions to the heart tissue or to the blood vessels in the area closed by surgical wire.
  • wire used for this surgical technique is traditionally thin and during the closure around the appendage by the surgeon, it can result in the cutting of tissue with great risk of major bleeding.
  • the present invention aims at overcoming the above drawbacks concerning the state of the art; namely it has the object of developing a device for closing the left atrial appendage of the heart, of the type to be placed outside the appendage, which can be applied in an easy way, without damaging the tissue of appendage.
  • the device comprises at least an elastic band that is able to follow the expansion and contraction of cardiac tissue without opposing excessive resistance, however tightening uniformly the base of the appendage, keeping it closed.
  • the device according to the present invention has also the advantage that it can be easily placed around the base of the appendage, not only during open chest procedures, but also by endoscopic techniques, between the surface tissue of the heart and pericardium, without needing a surgery operation with open heart, so it is suitable even on patients who can not undergo this kind of operation.
  • Fig. 1 shows a schematic view of the left atrial appendage in an opening position, having on its base an annular elastic band device according to the present invention
  • Fig. 2 shows a view from above of the band in a condition according to fig. 1;
  • Fig. 3 shows a view from above of the band in a condition according to fig. 1;
  • Fig. 4 shows a view from above of the band in a condition according to fig. 2;
  • Fig. 10 shows a perspective of another embodiment of the device according to the invention, with a band associated with a helical spring;
  • Fig. 11 shows a side view of the device of fig. 10
  • Fig. 12 shows a cross-section of the device of fig. 10 wherein the spring is outside the band;
  • Fig. 13 shows a cross-section of a variant of the device of fig. 10 where the spring is within the band;
  • Fig. 14 shows a cross-section of a variant of the device of fig. 10 where the band is hollow;
  • Fig. 15 shows a perspective view of an executive form of the device consisting in a band associated with a spring in the form of a mesh;
  • Fig. 16 shows a view from above of an annular band provided with an elastic coupling.
  • Fig. 1 and 2 they illustrate the elastic annular band 1 object of this invention in its simplest executive form, placed around the base of appendage 10:
  • Fig. 1 illustrates the band, which is placed in an open condition at the base of appendage 10, while in fig. 2 there is shown the closed condition of appendage 10.
  • annular elastic band of figg.l and 2 respectively, in a view from above: we can easily understand the functioning thereof.
  • the elastic nature of the band allows its first enlargement (fig. 1 and 3) during the positioning around appendage 10; this widening is achieved for example through a surgical forceps or other appropriate surgical tool (not shown), which maintains the annular elastic band 1 in a enlarged condition while it is placed.
  • the annular elastic band 1 After positioning (fig. 2 and 4) the annular elastic band 1 is released from the surgical forceps and returns to its original size (as a result of its elastic return due to the material which is made from), so as to tighten the base of appendage 1 causing the desired closure thereof.
  • the shape of the device 1 and its elastic properties can tighten the base of appendage 10 along an area with an height substantially equal to the width of the device, with the advantage to spread the compression force on a relatively large area, especially when compared with surgical sutures normally used in which the tightening force is concentrated in the small area of contact between the wire and tissue of the appendage.
  • annular elastic band 1 is illustrated in its simplest form, consisting of an elastic ring preferably made of silicone rubber for medical use, with a cross-section substantially rectangular, as shown in fig. 5.
  • annular elastic band 1 can have different cross-sectional shapes, such as circular as in fig. 6, or elliptical as in fig. 7, or polygonal as in fig. 8 in which (just for example) is illustrated a hexagonal section.
  • an hollow annular elastic band whose core is not full but has a cavity 3 extending longitudinally inside the annular elastic band.
  • the cavity 3 can be continuous or discontinuous along the longitudinal extension of band
  • the cavity is best suited for absorbing the little vibration or those of higher frequency.
  • the elastic band having an elastic element, made of different material; a preferred form for the elastic element consists in a coil spring made from a biocompatible metal alloy, for example NiTinol®.
  • the function of the elastic element is twofold: on the one hand it improves the sealing of band 1 and on the other hand, in case of rupture of 1 band, it prevents the latter from moving off its position around the base of appendage 10.
  • the spring coil 2 develops longitudinally along the band 1, continuously.
  • the coil spring 2 can be associated with the annular elastic band in different ways: fig. 12 illustrates the case where the coil spring is wrapped around the annular band 1, outside the band itself, while fig. 13 illustrates the section of a device in which the spring coil is placed inside of the elastomeric material constituting the band 1.
  • This second type of spring-band combination has the advantage of preventing the spring to enter into direct contact with the cardiac tissue: this will prevent damage to the heart, resulting from contact with the wire of the spring.
  • the device where the elastomeric band 1 is associated with a spring can be made by extrusion.
  • the band 1 may be hollow, having a cavity 3 which develops longitudinally inside, with the same advantages already reported above; this variation is illustrated in fig. 14.
  • elastic band Another advantageous executive form of elastic band is shown in fig. 15, where it consists in a mesh 5, for example a metallic mesh in NiTinol®: elasticity is provided by the mails of the mesh 5 located, in the form shown, around the band 1.
  • the mesh 5 could be located inside the material of the band 1, and band 1 could be provided with a cavity 3, in the same way as described above for the previous cases.
  • the cross-section of the band 1 and the mesh 5 can be any.
  • One possible variant is shown schematically in fig. 16, in which the annular elastic band 1 and, if present, the elastic element are opened through a coupling 4: in this case, the device in accordance with the present invention will be when it is unrolled and the coupling 4 in position open, as a simple strip, which is then closed on itself to generate the annular form illustrated, and blocked by the coupling 4.
  • the materials used for manufacturing the band 1 are different types of medical silicone or other silicone-based polymers; as it is well known, medical silicone is biocompatible and hypoallergenic.
  • silicones products for medical use produced by Polymer Technology Systems LTD, known with the commercial name of Liquid Silicone Rubber Med 4801, 4805, 4810, 4815, 4820, 4830, 4840, 4850, 4860, 4870, 4880.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention porte sur un dispositif de fermeture d'appendice auriculaire gauche pour le cœur, du type de ceux appropriés pour être placés à l'extérieur de l'appendice (10) pour le fermer. Conformément à la présente invention, ledit dispositif comprend une bande élastique annulaire (1), en particulier en silicone médical ou en un polymère comprenant du silicone médical, qui est tout d'abord agrandie durant le positionnement autour de l'appendice (10), et après le positionnement, la bande élastique annulaire (1) est libérée des pinces chirurgicales et retourne à sa dimension initiale (par suite de son retour élastique dû à la matière à partir de laquelle elle est faite), de façon à resserrer la base d'appendice (1), provoquant la fermeture désirée de celle-ci. Dans un nouveau perfectionnement, ledit dispositif comprend un élément élastique (2, 5) associé à la bande élastique annulaire (1), par exemple un ressort hélicoïdal (2), ou une maille, en particulier fait d'un alliage métallique biocompatible.
PCT/IB2008/000430 2008-02-28 2008-02-28 Dispositif de fermeture d'appendice auriculaire gauche Ceased WO2009106907A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IB2008/000430 WO2009106907A1 (fr) 2008-02-28 2008-02-28 Dispositif de fermeture d'appendice auriculaire gauche

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2008/000430 WO2009106907A1 (fr) 2008-02-28 2008-02-28 Dispositif de fermeture d'appendice auriculaire gauche

Publications (1)

Publication Number Publication Date
WO2009106907A1 true WO2009106907A1 (fr) 2009-09-03

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015152741A1 (fr) 2014-03-31 2015-10-08 Jitmed Sp. Z.O.O. Dispositif d'occlusion de l'appendice auriculaire gauche
US9737309B1 (en) 2010-06-24 2017-08-22 Niv Ad System for occlusion of left atrial appendage
CN110974331A (zh) * 2019-12-16 2020-04-10 上海长海医院 一种封堵面为可吸收材料的左心耳封堵器
US10631868B2 (en) 2010-06-24 2020-04-28 Niv Ad System for occlusion of left atrial appendage
CN113274095A (zh) * 2020-02-19 2021-08-20 刘健 阻止血栓脱落心耳钳

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005060838A2 (fr) * 2003-12-17 2005-07-07 Edwards Lifesciences Corporation Dispositif d'exclusion d'appendice de l'oreillette gauche
EP1600108A2 (fr) * 2004-05-26 2005-11-30 IDX Medical, Ltd. Appareil et procédé d'occlusion d'une structure anatomique creuse
US20070027456A1 (en) * 2005-08-01 2007-02-01 Ension, Inc. Integrated medical apparatus for non-traumatic grasping, manipulating and closure of tissue
WO2007127664A1 (fr) * 2006-04-28 2007-11-08 Medtronic, Inc. Procédés et dispositifs d'occlusion d'un appendice auriculaire

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005060838A2 (fr) * 2003-12-17 2005-07-07 Edwards Lifesciences Corporation Dispositif d'exclusion d'appendice de l'oreillette gauche
EP1600108A2 (fr) * 2004-05-26 2005-11-30 IDX Medical, Ltd. Appareil et procédé d'occlusion d'une structure anatomique creuse
US20070027456A1 (en) * 2005-08-01 2007-02-01 Ension, Inc. Integrated medical apparatus for non-traumatic grasping, manipulating and closure of tissue
WO2007127664A1 (fr) * 2006-04-28 2007-11-08 Medtronic, Inc. Procédés et dispositifs d'occlusion d'un appendice auriculaire

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9737309B1 (en) 2010-06-24 2017-08-22 Niv Ad System for occlusion of left atrial appendage
US10631868B2 (en) 2010-06-24 2020-04-28 Niv Ad System for occlusion of left atrial appendage
US10660649B2 (en) 2010-06-24 2020-05-26 Niv Ad System for occlusion of left atrial appendage
WO2015152741A1 (fr) 2014-03-31 2015-10-08 Jitmed Sp. Z.O.O. Dispositif d'occlusion de l'appendice auriculaire gauche
US10349948B2 (en) 2014-03-31 2019-07-16 Jitmed Sp. Z. O.O. Left atrial appendage occlusion device
CN110974331A (zh) * 2019-12-16 2020-04-10 上海长海医院 一种封堵面为可吸收材料的左心耳封堵器
CN110974331B (zh) * 2019-12-16 2022-02-25 上海长海医院 一种封堵面为可吸收材料的左心耳封堵器
CN113274095A (zh) * 2020-02-19 2021-08-20 刘健 阻止血栓脱落心耳钳
CN113274095B (zh) * 2020-02-19 2024-09-24 刘健 阻止血栓脱落心耳钳

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