EP1903952A1 - Implant endovasculaire pour l'obturation d'un vaisseau sanguin - Google Patents

Implant endovasculaire pour l'obturation d'un vaisseau sanguin

Info

Publication number
EP1903952A1
EP1903952A1 EP06775694A EP06775694A EP1903952A1 EP 1903952 A1 EP1903952 A1 EP 1903952A1 EP 06775694 A EP06775694 A EP 06775694A EP 06775694 A EP06775694 A EP 06775694A EP 1903952 A1 EP1903952 A1 EP 1903952A1
Authority
EP
European Patent Office
Prior art keywords
implant
constriction
wall
tubular
blood vessel
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.)
Withdrawn
Application number
EP06775694A
Other languages
German (de)
English (en)
Inventor
Bernhard Kramann
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.)
Campus & Cokg GmbH
Original Assignee
Campus & Cokg GmbH
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 Campus & Cokg GmbH filed Critical Campus & Cokg GmbH
Publication of EP1903952A1 publication Critical patent/EP1903952A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A61B17/12118—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm for positioning in conjunction with a stent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12177—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices

Definitions

  • the invention relates to an endovascular implant for closing the blood vessel according to the type mentioned in the preamble of claim 1, a method for its production and a medical kit containing such an implant.
  • Such an implant is introduced, for example, by means of a catheter into a blood vessel, which has a short circuit between the artery and vein with increased flow, so that the implant allows the fine-dose positioning of sealing material without the risk of flooding. Furthermore, such an implant allows the dosable constriction of a vessel over a period of time to be determined until the final closure, so as to accustom the target organ within this period to the lack of blood and to avoid tissue death.
  • a living, human or even animal organism is essentially supplied by a widely branched vascular system.
  • arteriovenous short-circuits are rare, they are potentially dangerous diseases, depending on size and target organs.
  • the best-known arteriovenous shorts occur in certain heart defects and can be treated either by surgery or by the use of occlusive membranes by means of vascular catheters.
  • Another large group of arteriovenous short circuits are vascular malformations of the pulmonary arteries with shunts to the pulmonary veins. They are frequently observed in so-called Osler's disease. Such short circuits can lead to increased work of the heart and premature heart failure.
  • the state of the art for treating such arteriovenous malformations with short circuits between the pulmonary artery and the pulmonary vein is the introduction of embolization material via a catheter into a branch of a pulmonary artery, which leads to such a malformation with an arteriovenous shunt.
  • This artery prior to its entry into the malformation, releases regular branches into the lung tissue, which should be spared as far as possible in order to avoid the clinical symptoms of pulmonary embolism.
  • the embolization material must therefore be deposited immediately before the confluence with the deformity.
  • the deformity has an often bulbous, sometimes aneurysmal extension of the vessel, which then continues in the sense of a short circuit after a change of direction by 180 ° as a vein and pulls directly to the atrium of the left heart.
  • a short circuit there is a high blood flow in the supplying branch.
  • the embolization material used to occlude these vascular malformations consists of platinum-containing coils, the coils which are stretched into the catheter and which form a tangle upon exiting the catheter tip, ideally just before the passage of the artery blocked in the aneurysmal extension of the vessel.
  • Such coils for thrombus formation are known, for example, from WO 93/16650.
  • a spiral is not sufficient, so that several spirals are needed to completely stop the blood flow.
  • the afferent branch of the pulmonary artery is greatly enlarged.
  • the extension can be 20 to 30 mm and more.
  • the coils mentioned above have the disadvantage that the doctor can not say in advance exactly to what size the coil to be placed in the respective blood vessel unfolds.
  • the spiral is over-dimensioned in terms of its dimensions, it can not unfold as intended in the form of a coil, but remains stretched in the vessel section which is too narrow. If this is the case, the side branches still pulling to the healthy parts of the lungs are clogged. For this reason, it requires great experience of the doctor to avoid complications. If there is a high flow in a significantly expanded vessel with the risk of runoff, one tries to anchor the spiral with its beginning part in one of the outgoing healthy side branches, so that it can lie with its largest part in the pathologically enlarged vessel section without being washed off, even if it is relatively undersized.
  • the first spiral serves as a flow obstacle and then brings the following in a stable position.
  • a maneuver is not easy, since pulsation and respiratory movements make it difficult to conduct the vascular catheter.
  • Another way to avoid complications is the use of targeted removable spirals, which are only completely detached from the catheter, when it appears that their larger, already leaked from the catheter portion in the vessel can be firmly wedged.
  • the detachment from the catheter can be achieved by threads or also galvanically. These products are in practical use, but they are very expensive and not completely reliable. For example, thread detachment can be problematic if the catheter has to make many turns as it passes through the right heart and pulmonary arteries.
  • the object of the present invention is to overcome the problems described above and an endovascular
  • the implant should also be suitable for large diameter blood vessels.
  • the links form a lattice and / or spiral structure. Due to this structure, the tubular, stent-like implant can grow into the blood vessel wall, so that the risk that the implant later dissolves again can be greatly reduced.
  • the implant has anchoring devices with the help of which the implant can be placed safely and permanently in the blood vessel. In this way it can be ensured that the implant once placed in place does not become detached again. Such anchoring is described for example in the patent DE-A 203 14 392.
  • the constriction is arranged at a distal end of the tubular wall.
  • the terminal design has the advantage that the constriction responsible for the occlusion of the vessel can be pushed directly to the site which is impaired by a rupture or an aneurysm.
  • Implant narrowing transverse structure reduces the cross-sectional lumen or area by at least 80%, preferably by at least 90%, with a reduction of at least 95% being particularly preferred.
  • the cross-sectional narrowing is such that the blood flow can be completely prevented.
  • the amount of flow is adjustable during placement of the stent or at a later time.
  • bifurcation located at the distal end of the bifurcation may also project into the bloodstream at the bifurcation and cause undesirable flow turbulence.
  • the constriction is disposed in the region between the ends of the tubular implant, whereby an hourglass-shaped structure is formed. In this way it can be prevented that through the constriction protruding wire ends can injure the vessel wall or cause unwanted flow turbulence.
  • This embodiment is particularly advantageous when the implant has, between its distal ends, a double cone-shaped constriction which forms a constriction or constriction arranged substantially transversely to the longitudinal axis of the tubular, stent-like implant.
  • the coils deposited upstream from the constriction are urged by the bloodstream against the inside of the cone facing them, and the passage of individual wire ends through the constriction is thus effectively prevented.
  • This embodiment is particularly advantageous in combination with a further preferred embodiment, which provides that in the lumen or cavity of the tubular implant Wire element or a coil in the form of a spiral double cone is stored.
  • Such wire elements are z. B. from DE-A 197 04 269 known. They have the advantage that they can be safely stored and locked in a tubular implant with a double conical constriction. They also have the advantage that they can be folded together prior to placement in the implant and can be pushed through narrow openings in this state, as z. B. may be arranged in a constriction according to one of the above claims. In this way, the wire element can be partially pushed through the opening and unfolds in the subsequent expansion on both sides of the transverse to the longitudinal direction or axis of the stent-like implant arranged constriction, which can be at least approximately completely closed.
  • the wall elements of the implant according to the invention and / or the wire elements deposited in its lumen consist in a preferred embodiment of a shape memory material.
  • shape memory materials are preferably nickel-titanium alloys or copper-zinc-aluminum alloys.
  • the unfolded, the diameter of the blood vessel to be treated corresponding shape is impressed on the blank for the implant according to the invention in known manner for shape memory materials.
  • the implant is compressed to a small diameter state and introduced into the blood vessel by means of a catheter, where the implant is returned to the previously impressed shape by heating to above the so-called conversion temperature.
  • this deployment process can be assisted by using a balloon catheter.
  • the tubular implant and / or deposited in the lumen wire elements made of stainless steel, platinum or plastic. Since these materials have no shape memory properties, a tubular implant made therefrom must be deployed in place using a balloon catheter.
  • the surface of the tubular implant or the wire elements according to the invention is also particularly preferred for the surface of the tubular implant or the wire elements according to the invention to be processed, in particular finished, smoothed, and / or polished. In this way, a smooth surface results, which in particular meets the requirements of the biocompatibility of the implant.
  • the stent may be uncoated or coated by conventional materials to achieve particular biological effects.
  • the tubular implant consists of a rigid and a flexible material.
  • the rigid material may be z. B. may be tungsten, while it may be the flexible material, for example, a spring steel.
  • the anchoring means and / or the cross-sectional constricting implant made of the rigid material, while the remaining regions of the tubular implant made of flexible material.
  • a method for producing an implant according to the invention is provided, which is characterized in that a circumferentially extending wall element is arranged in the implant, which is not radially elastically expandable and in the expanded state a substantially transversely to the longitudinal direction of the tubular implant arranged constriction of its cavity formed.
  • kits of parts comprising an implant according to the invention and a helically or coil-like deforming wire element for deposition in the implant and / or a balloon catheter for placement of an implant which does not expand or only diminish at least at one point ,
  • a balloon catheter for the placement of an implant according to the invention.
  • Such balloon catheters are z.
  • the placement of stents used for the dilation of stenoses is known.
  • the stent is mounted on the balloon catheter, inserted into the blood vessel to be treated and dilated in the area affected by the stenosis to deploy the stent and place it in place.
  • the present invention provides for the first time to use a balloon catheter for the placement of an implant according to the invention for the closure of a blood vessel. This is particularly advantageous because a lot is already known about the proper use of balloon catheters in endovascular therapy. Thus, it is possible here to resort to a wealth of experience which substantially facilitates the successful establishment of the aneurysm therapy with the aid of the implants according to the invention.
  • the implant according to the invention is preferably mounted on a cathodal catheter which is introduced into the blood vessel to be treated and then dilated in the region in which the closure is to take place in order to produce the stent-like, unfold tubular implant and place it in place.
  • the balloon catheter is preferably designed such that it does not expand or only diminish at least at one point. In this way, it is ensured that the tubular implant at this point not or only partially unfolded, whereby a constriction in the cavity or the tube is formed.
  • the constriction according to the invention which is arranged essentially transversely to the longitudinal axis of the tubular, stent-like implant, is therefore formed at this point. In particular, the above-mentioned double conical configuration of the constriction of the implant can thus be formed.
  • This type of implantation is particularly suitable for the placement of tubular implants that are not made of shape memory material.
  • a balloon catheter for placement of an implant according to the invention is provided. This is characterized by the fact that it does not expand or only diminish at least at one point and thus enables the production of an implant according to the invention.
  • the balloon catheter can be prepared, for example, by previously setting a wire loop so that it does not expand or only diminish at least at one point.
  • the exact positioning of the wire loop determines the later arrangement of the resulting constriction or narrowing of the tubular implant.
  • it may also be achieved in any other suitable manner that the catheter does not expand at at least one location.
  • Another inventive method for producing an implant according to one of the preceding claims provides that the at least one spiral or coil-like unfolding wire or the wire element in the form of a double cone in front of the Placement of the implant is placed in the blood vessel to be treated in the lumen of the implant.
  • the wire elements or coils are designed such that they can be deposited through the lattice-shaped or spiral wall of the tubular implant into the dead space formed between the vessel wall and the constriction or lumen. In this way, not only is it impossible to flush the coils, but it is also possible to control the degree of constriction by the amount and size of coils deposited pushing the wall of the implant into the interior of the vessel, thus narrowing or even narrowing the lumen as desired close.
  • the deposition can be done by means of conventional, known in the art catheters.
  • the basic structure of the tubular implant is essentially formed from a stent.
  • stents are known, for example, from the DE-A 102 43 136 of the applicant of the present invention. They are used in tubular hollow organs in order to expand or keep them open and thus prevent or treat stenoses, vascular occlusions and infarcts.
  • a stent-like implant according to the invention also has a substantially transverse to its longitudinal direction arranged constriction or constriction structure, which may be attached to both the malformation-proximal end and other portions of the implant. If the implant is released from the catheter, it does not form a flow obstacle on its own.
  • FIG. 8 shows the use of an implant according to the invention in the splenic artery.
  • 9 shows the laying down of coils or wire elements according to the invention in a dead space (a) formed between the vessel wall and the implant wall, as well as the closure (b) produced therewith.
  • a plurality of spirally or coil-like unfolding wires are stored in the lumen 22 of the implant 20 .
  • These wires which form a large surface area and are also referred to as coils 23, very quickly deposit platelets when the implant 20 is placed in a blood vessel, thus forming a thrombus, through which the vessel is finally closed.
  • the coils 23 are disposed in the lumen of the implant 20 and are urged by the bloodstream against the inside of the downstream cone of the constriction 21 facing them, thus preventing them from becoming detached and flushed away. It is therefore impossible that they have serious consequences
  • the wire element can be safely stored and locked in the implant 49 with a double-conical constriction 51 and can be placed in the tubular lumen prior to placement merge and push in this state through tight openings, as z. B. are formed in the constriction 51.

Landscapes

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

Abstract

Implant endovasculaire (10) expansible de type stent, adapté en particulier pour obturer un vaisseau sanguin (31). Ledit implant possède une paroi tubulaire circonférentielle s'étendant autour d'un axe longitudinal, constituée d'une structure sous forme de grille souple, à extension radiale, la paroi entourant un espace creux cylindrique à section transversale. Ledit implant est caractérisé en ce que l'espace creux cylindrique défini par la paroi présente un rétrécissement le long de son axe en au moins un point.
EP06775694A 2005-07-11 2006-07-11 Implant endovasculaire pour l'obturation d'un vaisseau sanguin Withdrawn EP1903952A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102005032308A DE102005032308A1 (de) 2005-07-11 2005-07-11 Endovaskulares Implantat für den Verschluss eines Blutgefäßes
PCT/DE2006/001194 WO2007006286A1 (fr) 2005-07-11 2006-07-11 Implant endovasculaire pour l'obturation d'un vaisseau sanguin

Publications (1)

Publication Number Publication Date
EP1903952A1 true EP1903952A1 (fr) 2008-04-02

Family

ID=36950529

Family Applications (1)

Application Number Title Priority Date Filing Date
EP06775694A Withdrawn EP1903952A1 (fr) 2005-07-11 2006-07-11 Implant endovasculaire pour l'obturation d'un vaisseau sanguin

Country Status (4)

Country Link
US (1) US20090177221A1 (fr)
EP (1) EP1903952A1 (fr)
DE (1) DE102005032308A1 (fr)
WO (1) WO2007006286A1 (fr)

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Publication number Priority date Publication date Assignee Title
DE102007032339B4 (de) * 2007-07-11 2010-03-25 Acandis Gmbh & Co. Kg Vorrichtung zum Verschließen von Gefäßaneurysmen
EP2182892B1 (fr) * 2007-07-30 2020-08-12 Audubon Technologies, LLC Dispositif pour maintenir des ostium de sinus paranasaux ouverts
US10076339B2 (en) 2011-01-11 2018-09-18 Amsel Medical Corporation Method and apparatus for clamping tissue layers and occluding tubular body lumens
WO2015134768A1 (fr) 2011-01-11 2015-09-11 Amsel Medical Corporation Procédé et appareil pour occlure un vaisseau sanguin et/ou d'autres structures tubulaires
US10398445B2 (en) 2011-01-11 2019-09-03 Amsel Medical Corporation Method and apparatus for clamping tissue layers and occluding tubular body structures
US10820895B2 (en) 2011-01-11 2020-11-03 Amsel Medical Corporation Methods and apparatus for fastening and clamping tissue
ES2676661T3 (es) * 2011-01-17 2018-07-23 Metactive Medical, Inc. Dispositivo de endoprótesis de esfera
CA2835427A1 (fr) * 2011-05-11 2012-11-15 Microvention, Inc. Dispositif permettant d'occlure une lumiere
GB2522034B (en) 2014-01-10 2015-12-02 Cook Medical Technologies Llc Implantable medical device with flexible connection
GB2527550B (en) * 2014-06-25 2016-09-21 Cook Medical Technologies Llc Implantable medical device with lumen constriction

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DE4334140C2 (de) * 1993-10-07 1996-04-18 Angiomed Ag Stent und Vorrichtung mit Stent
US6312407B1 (en) * 1995-06-05 2001-11-06 Medtronic Percusurge, Inc. Occlusion of a vessel
US5788626A (en) * 1995-11-21 1998-08-04 Schneider (Usa) Inc Method of making a stent-graft covered with expanded polytetrafluoroethylene
US20010041900A1 (en) * 1999-12-21 2001-11-15 Ovion, Inc. Occluding device and method of use
US5919224A (en) * 1997-02-12 1999-07-06 Schneider (Usa) Inc Medical device having a constricted region for occluding fluid flow in a body lumen
US6120534A (en) * 1997-10-29 2000-09-19 Ruiz; Carlos E. Endoluminal prosthesis having adjustable constriction
US20020123790A1 (en) * 1999-09-28 2002-09-05 White Geoffrey Hamilton Enhanced engagement member for anchoring prosthetic devices in body lumen
US6953476B1 (en) * 2000-03-27 2005-10-11 Neovasc Medical Ltd. Device and method for treating ischemic heart disease
WO2003028522A2 (fr) * 2001-03-27 2003-04-10 Neovasc Medical Ltd. Implant reducteur de flux
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US20050107867A1 (en) * 2003-11-17 2005-05-19 Taheri Syde A. Temporary absorbable venous occlusive stent and superficial vein treatment method

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Also Published As

Publication number Publication date
WO2007006286A1 (fr) 2007-01-18
US20090177221A1 (en) 2009-07-09
DE102005032308A1 (de) 2007-01-18

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