WO1999040849A1 - Surgical device for occlusion of defects - Google Patents

Surgical device for occlusion of defects Download PDF

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Publication number
WO1999040849A1
WO1999040849A1 PCT/CH1999/000058 CH9900058W WO9940849A1 WO 1999040849 A1 WO1999040849 A1 WO 1999040849A1 CH 9900058 W CH9900058 W CH 9900058W WO 9940849 A1 WO9940849 A1 WO 9940849A1
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WO
WIPO (PCT)
Prior art keywords
distal
proximal
integral
defect
surgical instrument
Prior art date
Application number
PCT/CH1999/000058
Other languages
French (fr)
Inventor
Hendrik Tevaearai
Jeffrey Jump
Original Assignee
Jeffrey Jump
Hendrik Tevaearai
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 Jeffrey Jump, Hendrik Tevaearai filed Critical Jeffrey Jump
Priority to AU22617/99A priority Critical patent/AU2261799A/en
Priority to EP99902484A priority patent/EP1054628A1/en
Publication of WO1999040849A1 publication Critical patent/WO1999040849A1/en

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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, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00588—Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00619—Locking means for locking the implement in expanded state
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623—Introducing or retrieving devices therefor

Definitions

  • the present invention relates to a surgical device for occluding cardiac, muscular or other defects. It also includes 1 instrument used for positioning! the occlusion device as well as the method of using the device and 1 instrument
  • Common openings can exist between two cavities of the heart, main vessels, or other body cavities. They can also exist or be created in the wall of a hollow organ.
  • the most common forms of heart failure are intra-cellular communication.
  • CIA interventricular communication
  • CIV patent ductus arte ⁇ osus
  • Such openings can be congenital such as the Permeable Oval Foramen, acquired (eg following an infarction) or created (eg in a vessel by the introduction of vascular cannulas)
  • they cause leakage of blood (shunt) of a cavity to another or a v aisseau to another, decreased cardiac output and cause repercussions on other organs including the lungs, which can cause long-term inadequate of the heart
  • the Oval Foramen it can even result in a cerebral embolism
  • This defect tvpe often involves an operation open heart involving the use of a heart-lung machine in this tv pe of speech repair is to bring the edges of the defect when it is section relatively reduced, or use a patch, in Gore-Tex for example, when the defect section is large
  • the devices must be moved under occlusion retracted form their unfolded form may present only a very low level or even zero. of rigidity. This entails the risk of moving the occluder over time. As was shown some studies, the degree of occlusion of the defect is therefore incomplete in some cases. the displacement is such that the occlusion device detaches from the defect and may cause embolism.
  • the present invention has the lie to remedy the drawbacks previously bishops by resorting a surgical device for occlusion of a defect such that a mteraunisme communication. characterized in that it is constituted
  • distal part with a relatively rigid surface, substantially flat, even slightly curved, and greater than the section of the defect
  • distal part being provided with mov ens to make it integral with an instrument of a proximal part with relatively rigid surface , substantially planar, even slightly curved, and greater than the section of the defect
  • proximal part being provided with means for making it integral with said instrument
  • the two parts being each provided with at least one fixing means for making integral with one another with respect to the
  • the periphery of the proximal part and / or the distal part piesente a higher degree of rigidity to the remaining surface remaining
  • This surface may be constituted of a membrane.
  • the proximal part and / or distal ends is provided with at least one orifice for introducing a pipe, to fix a v alve or other device
  • the device of the present invention is not introduced in retracted form into a catheter, which allows it to be given very good rigidity and therefore to obtain a more effective and longer occlusion. duration
  • the present invention also relates to a tool used for positioning the occlusion device which comprises:
  • a rod provided at its distal end with means for making it integral with the distal part of a sleeve within which the rod can move, provided at its distal end with means for making it integral at least in direction of the distal end of the stem
  • the rod and the sleeve being provided with gripping means at their respective proximal ends.
  • the gripping means may be of the pistol that incorporates the rod and the sleeve.
  • the rod and the sleeve can be rigid, flexible, malleable, straight or curved.
  • This type of instrument is of particularly easy use, small length and stiffness that can confer achieve further improved control and greater precision of the operation.
  • the occlusion device according to the invention and the associated instrument have the merit of being little traumatic for the patient.
  • a repair at the heart for example, simply perform a mini-incision thoracic skin and Intervention beating heart. either without extra-corporeal circulation.
  • the apparatus and instrument of the present invention besides their facilitated manual, can be manufactured at low cost, in any case at a lower cost to minimally invasive surgical devices of the prior art.
  • FIG. 1 shows a sectional view of an embodiment of the device of occlusion of the present invention.
  • Figure 2 shows a three-dimensional view of the device of Figure 1
  • FIG. 3 represents an embodiment of the instrument used to introduce the device of FIG. 1 4 shows the device of Figures 1 and 2 al fixed instrument of Figure 3
  • Figure 5 shows the path to an intracardiac defect
  • I a figure 6 represents the various stages of positioning of the device of figure 1
  • FIG. 10 An embodiment of the occlusion device according to the invention is shown in Figures 1 and 2 It consists of a distal part (1) and a proximal part (3) The general shape of each part is circular and of diameter slightly greater than that of the defect tv pically from 1 to 5 cm Each part is provided with a fixing cylinder (8 4) located in the center of said part, which makes it possible to make it integral with the other part by snap-fastening.
  • cv fixing rod (8) of the distal piece (1) has along its outer wall a series of annular grooves
  • the disc of the distal piece is slightly concav e on the side where the cv fixing liner (8) is located This same disc also has an edge (10) at its periphery which is curved in the direction of the fixing cylinder (8)
  • the cv fixing liner (4) of the proximal part (3) has along its internal wall a series of annular grooves 0 complementary to the grooves of the fixing liner cv (8) of the distal piece (1) so as to ensure effective fixing when the fixing cvlinder (8) of the distal piece (1) enters the lv cv of fixing (4) of the proximal part (3)
  • the interior of the fixing cylinder (8) of the distal part (1) is hollow and provided with a screw thread (2) in order to make said distal part (1) integral with the rod (6) of 1 instrument of
  • the free end of the fixing cylinder (4) of the proximal part (3) is designed so as to act as a stop for the distal end (1 1) of the sleeve (5) of 1 positioning instrument when the proximal part ( 3) approaches the distal part (1)
  • Each part (1. 3) can be produced by molding in a single element The material uses
  • 0 may be of Del ⁇ n or other biocompatible material which may have a high degree of rigidity according to the case.
  • the material may also be biodegradable I e occlusion device may be covered by an activated substance such as heparin 1
  • the general shape of the distal parts (1) and proximal (3) may be oval, or more generally proportionally identical shape to the section of the defect. Their surface can be flat or slightly curved. The degree of curvature of a workpiece relative to the other is not necessarily identical.
  • the distal parts (1) and proximal (3) may be provided with several attachment means distributed over the entire surface of each piece.
  • the means for fixing the parts together are distinct from the means for fixing these same parts to the instrument.
  • the snap is not the only planned to attach the pieces together, any system likely to ensure effective fixing can be used.
  • FIG. 3 shows the positioning instrument of the occlusion device of Figures 1 and 2. It consists of a rod (6) and a sleeve (5) wherein the rod (6) can move.
  • the rod is provided at its distal end (7) with a threaded part capable of being fixed inside the fixing cylinder (8) of the distal part (1).
  • the distal end of the sleeve (5) is intended to come into contact with the free end of the fixing cylinder (4) of the proximal part.
  • the rod (6) and the sleeve (5) are provided at their respective proximal ends to an input device enabling the surgeon to make among others a rotational movement of the rod (6) and the sleeve translational movement ( 5).
  • FIG. 4 shows the occlusion device attached to the instrument as it appears before use.
  • the distal end of the rod (6) is screwed to the inside of the fitting cylinder (8) of the distal part (1).
  • the rod (6) is placed inside the sleeve (5) which is in contact with the free end of the fitting cylinder (4) of the proximal part (3). Note that at this stage the distal parts (1) and proximal (3) have been fixed one to the other. It is perfectly conceivable to present this configuration in its storage packaging.
  • FIGS 5 and 6 illustrate an intervention on the repair of atrial septal.
  • pericardium next to the right atrium is incised.
  • a scholarship (13) is placed at the right atrium (see Figure 5.2. A), between the upper and lower vena cava. This will ensure the tightness of the right atrial cavity during maneuvers endocardial one hand, and closing the atrial orifice after introduction of the occluder other.
  • An ear incision is placed in the center of the purse.
  • the thoracic cavity may be filled with water before the maneuver.
  • the complete occlusion device (or successively the distal and proximal parts) is first introduced into the right atrium (see Figures 5.2.c and 6a).
  • the rod (6) is then actuated so as to introduce the distal part (1) into the left atrium through the defect (see FIG. 6b).
  • the distal part (1) is of a diameter greater than that of the section of the defect, the passage of said distal part (1) through the defect presents no problem.
  • the distal part is placed against the edges of the defect. Its correct positioning is verified by transesophageal ultrasound.
  • the proximal part (3) is pushed by the sleeve in the direction of the distal part (1) while keeping the latter pressed against the edges of the defect so as to allow the fixing of the two parts by snap-fastening (see FIG. 6c).
  • the rod (6) is unscrewed and removed with the sleeve (see Figure 6d). tight purse and bound so as to close the ear hole.
  • the present invention therefore has the merit of presenting several advantages over the prior art:
  • the use and control of implementation of the occlusion device are easier, the rigidity of the occlusion device ensures excellent and long-lasting fixation, positioning accuracy is facilitated by relatively short and rigid or semi-rigid instruments.
  • catheterization techniques of the prior art there 's no manipulation of peripheral vessels or repeated passage of the catheter in the intermediate vessels between the site of introduction of the instruments and the defect itself.
  • the manufacturing costs of the object of the present invention are also significantly reduced.

Abstract

The invention concerns a device for the occlusion of cardiac, vascular and other defects. It also concerns the instrument used for positioning the occlusion device as well as the method for using said device and instrument. The occlusion device consists of a distal part (1) with relatively rigid surface, substantially planar, even slightly curved, and greater than the defect cross section, said distal part (1) being provided with means (2) for making it integral with an instrument; a proximal part (3) with relatively rigid surface, substantially planar, even slightly curved, and greater than the defect cross section, said proximal part (3) being provided with means (4) for making it integral with said instrument. The two parts are provided each with at least fixing means (8, 9) for making them mutually integral.

Description

Dispositif chirurgical d'occlusion de défectuosités Surgical device for occluding defects
La présente inv ention se rapporte a un dispositif chirurgical d'occlusion de défectuosités cardiaques \ asculaires ou autres Elle comprend également 1 instrument utilise pour positionne! le dispositif d occlusion ainsi que la méthode d utilisation du dispositif et de 1 instrumentThe present invention relates to a surgical device for occluding cardiac, muscular or other defects. It also includes 1 instrument used for positioning! the occlusion device as well as the method of using the device and 1 instrument
Des ouv ertures anoi maies peuvent exister entre deux cav ités du cœur, des principaux v aisseaux ou d autres cavités du corps Elles peuvent également exister ou être créées dans la paroi d un organe creux Les formes de défectuosités cardiaques les plus fréquentes sont la communication înterauπculaire (CIA) la communication interventriculaire (CIV) et la patent ductus arteπosusCommon openings can exist between two cavities of the heart, main vessels, or other body cavities. They can also exist or be created in the wall of a hollow organ. The most common forms of heart failure are intra-cellular communication. (CIA) interventricular communication (CIV) and patent ductus arteπosus
De telles ouv ertures peuvent être congénitales tel que le Foramen Ovale Perméable, acquises (p ex consécutivement a un infarctus) ou créées (p ex dans un vaisseau par l'introduction de canules v asculaires) Dans le cas de défectuosités cardiaques, elles entraînent une fuite du sang (shunt) d'une cavité a l'autre ou d un v aisseau a l'autre, une diminution du rendement cardiaque et provoquent des repercussions sur les autres organes notamment les poumons, ce qui peut engendrer a long terme une insuffisance du cœur Dans le cas du Foramen Ovale, il peut même en résulter une embolie cérébraleSuch openings can be congenital such as the Permeable Oval Foramen, acquired (eg following an infarction) or created (eg in a vessel by the introduction of vascular cannulas) In the case of heart defects, they cause leakage of blood (shunt) of a cavity to another or a v aisseau to another, decreased cardiac output and cause repercussions on other organs including the lungs, which can cause long-term inadequate of the heart In the case of the Oval Foramen, it can even result in a cerebral embolism
Le traitement de ce tvpe de défectuosité a souvent consiste en une opération a cœur ouvert impliquant l'utilisation d'une machine cœur-poumon Dans ce tv pe d intervention la réparation consiste a rapprocher les bords de la défectuosité lorsque cette dernière est de section relativement réduite, ou utiliser un patch, en Gore-Tex par exemple, lorsque la section de la défectuosité est importanteThe treatment of this defect tvpe often involves an operation open heart involving the use of a heart-lung machine in this tv pe of speech repair is to bring the edges of the defect when it is section relatively reduced, or use a patch, in Gore-Tex for example, when the defect section is large
L'article intitule « Repair of Atπal Septal Defect Through a Right Thoracotomv » de Rosengart et al . Ann Thorac Surg 1993 , 55 pages 1 138-1 140. décrit une telle méthode que 1 on peut qualifier de lourde et traumatisante pour le patient Le brev et US 3 874 388 de King et al décrit un dispositif de chirurgie minimale invasive d'occlusion de défectuosités cardiaques ou vasculaires constitue d'une paire de pièces rétractables similaires a des parapluies qui sont placées de part et d'autre de la défectuosité Les parapluies sont achemines sous forme rétractée dans un cathéter pour être dépliés au niv eau de la défectuosité et fixés l'un à l'autre en un point centralThe article entitled "Repair of Atπal Septal Defect Through a Right Thoracotomv" by Rosengart et al. Ann Thorac Surg 1993, 55 pages 1 138-1 140. describes such a method that 1 can be described as heavy and traumatic for the patient The pat and US 3,874,388 to King et al discloses a minimally invasive of surgical device occlusion of cardiac and vascular defects is a pair of similar retractable parts are umbrellas which are placed on both sides of the defect umbrellas are routed in retracted form in a catheter to be folded on level water of the defect and secured one to the other at a central point
Les documents EP 474 887 Al . WO 93/13712. EP 541 063 A2. EP 545 091 A2. US 5 284 488. EP 655 222 Al et US 5 433 727 décriv ent des dispositifs similairesThe documents EP 474 887 Al. WO 93 / 13712. EP 541 063 A2. EP 545,091 A2. US 5,284,488. EP 655,222 A1 and US 5,433,727 describe similar devices
Bien que les dispositifs de l'art antérieur donnent une certaine satisfaction, il subsiste toujours plusieurs inconvénientsAlthough the devices of the prior art give some satisfaction, there are still several drawbacks
Etant donne que les dispositifs d'occlusion doivent être achemines sous forme retractée, leur forme dépliée ne peut présenter qu'un degré très faible, voire nul. de rigidité. Ceci entraîne le risque d'un déplacement du dispositif d'occlusion au cours du temps. Comme l'ont montrées certaines études, le degré d'occlusion de la défectuosité est par conséquent incomplet Dans certains cas. le déplacement est tel que le dispositif d'occlusion se détache de la défectuosité et peut provoquer une embolie.Given that the devices must be moved under occlusion retracted form their unfolded form may present only a very low level or even zero. of rigidity. This entails the risk of moving the occluder over time. As was shown some studies, the degree of occlusion of the defect is therefore incomplete in some cases. the displacement is such that the occlusion device detaches from the defect and may cause embolism.
Le placement des dispositifs de l'état de la technique est en outre malaisé du fait que leur introduction dans le patient et leur manipulation s'effectuent généralement par l'abord du pli inguinal, soit à une distance relativement grande de la défectuosité Par ailleurs, les manœuvres se font par l'intermédiaire de cathéters souples, ce qui diminue la précision du geste.The placement of the devices of the prior art is further difficult because their introduction into the patient and manipulation s' generally made by the first of the inguinal fold, or at a relatively large distance of the defect In addition, maneuvers are done through flexible catheters, which decreases the precision of movement.
Il v a par conséquent un besoin de remédier aux inconvénients mentionnes ci-dessus en recourant à un dispositif permettant d'assurer une occlusion complète et de longue durée des défectuosités cardiaques, v asculaires ou autres. Il v a également un besoin d'améliorer le contrôle et la précision du positionnement du dispositif d'occlusion La présente invention a le mente de remédier aux inconvénients évoques précédemment en recourant a un dispositif chirurgical d'occlusion d'une défectuosité telle qu'une communication mteraunculaire. caractérise en ce qu'il est constitueIt will therefore need to overcome the drawbacks mentioned above by using a device to ensure complete occlusion and long-term cardiac defects, or other v asculaires. It also goes a need to improve the control and positioning accuracy of the occluder The present invention has the lie to remedy the drawbacks previously bishops by resorting a surgical device for occlusion of a defect such that a mteraunculaire communication. characterized in that it is constituted
d une pièce distale de surface relativ ement rigide, sensiblement plane, v oire légèrement courbée, et supérieure à la section de la défectuosité, ladite pièce distale étant munie de mov ens pour la rendre solidaire a un instrument d une pièce proximale de surface relativement rigide, sensiblement plane, v oire légèrement courbée, et supérieure a la section de la défectuosité, ladite pièce proximale étant munie de moyens pour la rendre solidaire au dit instrumentof a distal part with a relatively rigid surface, substantially flat, even slightly curved, and greater than the section of the defect, said distal part being provided with mov ens to make it integral with an instrument of a proximal part with relatively rigid surface , substantially planar, even slightly curved, and greater than the section of the defect, said proximal part being provided with means for making it integral with said instrument
Les deux pièces étant munie chacune d au moins un moyen de fixation permettant de les rendre solidaires l'une par rapport a l'autreThe two parts being each provided with at least one fixing means for making integral with one another with respect to the
L'expression « pièce de surface relativement rigide » doit être comprise par opposition à une pièce de surface rétractable qui est introduite dans un cathéterThe expression "relatively rigid surface part" must be understood as opposed to a retractable surface part which is introduced into a catheter
Selon une variante de l'invention, la périphérie de la pièce proximale et/ou de la pièce distale piesente un degré de rigidité supérieur a la surface restante Cette surface restante peut être constituée d'une membrane.According to a variant of the invention, the periphery of the proximal part and / or the distal part piesente a higher degree of rigidity to the remaining surface remaining This surface may be constituted of a membrane.
Selon une autre v ariante de l'invention, la pièce proximale et/ou distale est munie d'au moins un orifice permettant d'introduire un tuyau, de fixer une v alve ou tout autre dispositifAccording to another v ariant of the invention, the proximal part and / or distal ends is provided with at least one orifice for introducing a pipe, to fix a v alve or other device
Comme on pourra le constater plus loin, le dispositif de la présente inv ention n est pas introduit sous forme retractée dans un cathéter, ce qui permet de lui conférer une très bonne rigidité et par conséquent d'obtenir une occlusion plus efficace et de plus longue durée La présente invention se rapporte aussi à un instrument utilisé pour positionner le dispositif d'occlusion qui est constitué :As will be seen below, the device of the present invention is not introduced in retracted form into a catheter, which allows it to be given very good rigidity and therefore to obtain a more effective and longer occlusion. duration The present invention also relates to a tool used for positioning the occlusion device which comprises:
- d'une tige munie à son extrémité distale de moyens pour la rendre solidaire à la pièce distale d'un manchon, à l'intérieur duquel la tige peut se déplacer, muni à son extrémité distale de moyens pour le rendre solidaire au moins en direction de l'extrémité distale de la tige- a rod provided at its distal end with means for making it integral with the distal part of a sleeve within which the rod can move, provided at its distal end with means for making it integral at least in direction of the distal end of the stem
La tige et le manchon étant munis de moyens de saisie à leurs extrémités proximales respectives. A titre d'exemple, les moyens de saisie peuvent être du type pistolet qui intègre la tige et le manchon. La tige et le manchon peuvent être rigides, souples, malléables, droits ou courbés.The rod and the sleeve being provided with gripping means at their respective proximal ends. As an example, the gripping means may be of the pistol that incorporates the rod and the sleeve. The rod and the sleeve can be rigid, flexible, malleable, straight or curved.
Ce type d'instrument est d'usage particulièrement aisé, la petite longueur et la rigidité que l'on peut lui conférer permettent d'atteindre en outre un meilleur contrôle et une plus grande précision de l'opération.This type of instrument is of particularly easy use, small length and stiffness that can confer achieve further improved control and greater precision of the operation.
Le dispositif d'occlusion selon l'invention et l'instrument associé ont le mérite d'être peu traumatisant pour le patient. Lors d'une réparation au niveau du cœur par exemple, il suffit de pratiquer une mini-incision cutanée thoracique et d'effectuer une intervention à cœur battant. soit sans circulation extra-corporelle.The occlusion device according to the invention and the associated instrument have the merit of being little traumatic for the patient. At a repair at the heart, for example, simply perform a mini-incision thoracic skin and Intervention beating heart. either without extra-corporeal circulation.
Le dispositif et l'instrument de la présente invention, outre leur emploi facilité, peuvent être fabriqués à faible coût, dans tous les cas à un coût inférieur aux dispositifs de chirurgie minimale invasive de l'état de la technique.The apparatus and instrument of the present invention, besides their facilitated manual, can be manufactured at low cost, in any case at a lower cost to minimally invasive surgical devices of the prior art.
La figure 1 représente une vue en coupe d'un mode de réalisation du dispositif d'occlusion de la présente invention.1 shows a sectional view of an embodiment of the device of occlusion of the present invention.
La figure 2 représente une vue tridimensionnelle du dispositif de la figure 1Figure 2 shows a three-dimensional view of the device of Figure 1
La figure 3 représente un mode de réalisation de l'instrument utilisé pour introduire le dispositif de la figure 1 La figure 4 représente le dispositif des figures 1 et 2 fixe a l'instrument de la figure 3FIG. 3 represents an embodiment of the instrument used to introduce the device of FIG. 1 4 shows the device of Figures 1 and 2 al fixed instrument of Figure 3
La figure 5 représente le chemin d accès a une défectuosité intracardiaqueFigure 5 shows the path to an intracardiac defect
I a figure 6 représente les différentes étapes de positionnement du dispositif de la figure 1I a figure 6 represents the various stages of positioning of the device of figure 1
a) Dispositif d'occlusiona) Occlusion device
10 Un mode de réalisation du dispositif d'occlusion selon l'invention est représente aux figures 1 et 2 II se compose d'une pièce distale (1 ) et d'une pièce proximale (3) La forme générale de chaque pièce est circulaire et de diamètre légèrement supérieur a celui de la défectuosité tv piquement de 1 a 5 cm Chaque pièce est munie d un cylindre de fixation (8 4) situe au centre de ladite pièce, qui permet de la rendre solidaire a l'autre pièce par encliquetage Le10 An embodiment of the occlusion device according to the invention is shown in Figures 1 and 2 It consists of a distal part (1) and a proximal part (3) The general shape of each part is circular and of diameter slightly greater than that of the defect tv pically from 1 to 5 cm Each part is provided with a fixing cylinder (8 4) located in the center of said part, which makes it possible to make it integral with the other part by snap-fastening.
13 cv lindre de fixation (8) de la pièce distale (1 ) présente le long de sa paroi externe une série de rainuies annulaires Le disque de la pièce distale est légèrement concav e du côte ou se trouve le cv lindre de fixation (8) Ce même disque présente en outre une bordure ( 10) a sa périphérie qui est recourbée en direction du cylindre de fixation (8) Le cv lindre de fixation (4) de la pièce proximale (3) présente le long de sa paroi interne une série de rainures annulaires 0 complémentaires aux rainures du cv lindre de fixation (8) de la pièce distale (1 ) de façon a assurer une fixation efficace lorsque le cvlindre de fixation (8) de la pièce distale ( 1 ) pénètre dans le cv lindre de fixation (4) de la pièce proximale (3)13 cv fixing rod (8) of the distal piece (1) has along its outer wall a series of annular grooves The disc of the distal piece is slightly concav e on the side where the cv fixing liner (8) is located This same disc also has an edge (10) at its periphery which is curved in the direction of the fixing cylinder (8) The cv fixing liner (4) of the proximal part (3) has along its internal wall a series of annular grooves 0 complementary to the grooves of the fixing liner cv (8) of the distal piece (1) so as to ensure effective fixing when the fixing cvlinder (8) of the distal piece (1) enters the lv cv of fixing (4) of the proximal part (3)
L intérieur du cylindre de fixation (8) de la pièce distale (1 ) est creux et muni d un pas de v is (2) afin de rendre ladite pièce distale (1 ) solidaire avec la tige (6) de 1 instrument deThe interior of the fixing cylinder (8) of the distal part (1) is hollow and provided with a screw thread (2) in order to make said distal part (1) integral with the rod (6) of 1 instrument of
2-> positionnement2-> positioning
L extrémité libre du cylindre de fixation (4) de la pièce proximale (3) est conçue de manière a serv n de butée pour l'extrémité distale (1 1) du manchon (5) de 1 instrument de positionnement lorsque la pièce proximale (3) se rapproche de la pièce distale (1 ) Chaque pièce (1. 3) peut être fabriquée par moulage en un seul élément Le matériau utiliseThe free end of the fixing cylinder (4) of the proximal part (3) is designed so as to act as a stop for the distal end (1 1) of the sleeve (5) of 1 positioning instrument when the proximal part ( 3) approaches the distal part (1) Each part (1. 3) can be produced by molding in a single element The material uses
"0 peut être du Delπn ou tout autre matériau biocompatible pouvant présenter un grand degré de rigidité Selon le cas. le matériau peut également être biodégradable I e dispositif d'occlusion peut être recouvert par une substance activ e telle que de 1 héparine Dans d'autres modes de réalisation de l'invention, la forme générale des pièces distale ( 1) et proximale (3) peut être ovale, ou plus généralement de forme proportionnellement identique à la section de la défectuosité. Leur surface peut être plane ou légèrement bombée. Le degré de courbure d'une pièce par rapport à l'autre n'est pas forcément identique."0 may be of Delπn or other biocompatible material which may have a high degree of rigidity according to the case. The material may also be biodegradable I e occlusion device may be covered by an activated substance such as heparin 1 In other embodiments of the invention, the general shape of the distal parts (1) and proximal (3) may be oval, or more generally proportionally identical shape to the section of the defect. Their surface can be flat or slightly curved. The degree of curvature of a workpiece relative to the other is not necessarily identical.
Selon un autre mode préférentiel de l'invention, les pièces distale (1) et proximale (3) peuvent être munies de plusieurs moyens de fixation répartis sur toute la surface de chaque pièce.According to another preferred embodiment of the invention, the distal parts (1) and proximal (3) may be provided with several attachment means distributed over the entire surface of each piece.
Selon un autre mode préférentiel de l'invention, les moyens pour fixer les pièces entre elles sont distincts des moyens de fixation de ces mêmes pièces à l'instrument.According to another preferred embodiment of the invention, the means for fixing the parts together are distinct from the means for fixing these same parts to the instrument.
L'encliquetage n'est pas le seul moyen envisagé pour fixer les pièces entre elles, tout autre système susceptible d'assurer une fixation efficace peut être utilisé. The snap is not the only planned to attach the pieces together, any system likely to ensure effective fixing can be used.
b) Instrumentb) Instrument
La figure 3 représente l'instrument de positionnement du dispositif d'occlusion des figures 1 et 2. Il est constitué d'une tige (6) et d'un manchon (5) dans lequel la tige (6) peut se déplacer.3 shows the positioning instrument of the occlusion device of Figures 1 and 2. It consists of a rod (6) and a sleeve (5) wherein the rod (6) can move.
La tige est munie à son extrémité distale (7) d'une partie filetée apte à se fixer à l'intérieur du cylindre de fixation (8) de la pièce distale (1).The rod is provided at its distal end (7) with a threaded part capable of being fixed inside the fixing cylinder (8) of the distal part (1).
L'extrémité distale du manchon (5) est destinée à entrer en contact avec l'extrémité libre du cylindre de fixation (4) de la pièce proximale.The distal end of the sleeve (5) is intended to come into contact with the free end of the fixing cylinder (4) of the proximal part.
La tige (6) et le manchon (5) sont munis à leur extrémités proximales respectives d'un dispositif de saisie permettant au chirurgien d'effectuer entre autre un mouvement de rotation de la tige (6) et un mouvement de translation du manchon (5).The rod (6) and the sleeve (5) are provided at their respective proximal ends to an input device enabling the surgeon to make among others a rotational movement of the rod (6) and the sleeve translational movement ( 5).
c) Mode opératoirec) Procedure
La figure 4 représente le dispositif d'occlusion fixé à l'instrument tel qu'il se présente avant l'utilisation. L'extrémité distale de la tige (6) est vissée à l'intérieur du cylindre de fixation (8) de la pièce distale (1). La tige (6) est placée à l'intérieur du manchon (5) qui est en contact avec l'extrémité libre du cylindre de fixation (4) de la pièce proximale (3). A noter qu'à ce stade les pièces distale (1 ) et proximale (3) ne sont pas encore fixées l'une à l'autre. Il est parfaitement envisageable de présenter cette configuration dans son emballage de stockage.4 shows the occlusion device attached to the instrument as it appears before use. The distal end of the rod (6) is screwed to the inside of the fitting cylinder (8) of the distal part (1). The rod (6) is placed inside the sleeve (5) which is in contact with the free end of the fitting cylinder (4) of the proximal part (3). Note that at this stage the distal parts (1) and proximal (3) have been fixed one to the other. It is perfectly conceivable to present this configuration in its storage packaging.
Les figures 5 et 6 illustrent une intervention relative à la réparation d'une communication interauriculaire.Figures 5 and 6 illustrate an intervention on the repair of atrial septal.
Au travers d'une minithoracotomie (12) (voir figure 5.1) de 2 à 5 cm selon la taille du dispositif d'occlusion prévu, le péricarde en regard de l'oreillette droite est incisé. Une bourse (13) est placée au niveau de l'oreillette droite (voir figure 5.2. a), entre les veines caves supérieures et inférieures. Celle-ci permettra d'assurer l'étanchéité de la cavité auriculaire droite durant les manœuvres endocardiaques d'une part, et de fermer l'orifice auriculaire après la mise en place du dispositif d'occlusion d'autre part. Une incision auriculaire est placée au centre de la bourse. Afin d'éviter le passage d'air dans la cavité auriculaire droite, la cavité thoracique peut être remplie d'eau avant cette manœuvre. Le dispositif d'occlusion complet (ou successivement les pièces distale puis proximale) est d'abord introduit dans l'oreillette droite (voir figures 5.2.c and 6a).Through a minithoracotomy (12) (see Figure 5.1) for 2 to 5 cm depending on the size of the device provided occlusion, pericardium next to the right atrium is incised. A scholarship (13) is placed at the right atrium (see Figure 5.2. A), between the upper and lower vena cava. This will ensure the tightness of the right atrial cavity during maneuvers endocardial one hand, and closing the atrial orifice after introduction of the occluder other. An ear incision is placed in the center of the purse. In order to avoid the passage of air into the right atrial cavity, the thoracic cavity may be filled with water before the maneuver. The complete occlusion device (or successively the distal and proximal parts) is first introduced into the right atrium (see Figures 5.2.c and 6a).
La tige (6) est ensuite actionnée de façon à introduire la pièce distale (1 ) dans l'oreillette gauche à travers la défectuosité (voir figure 6b). Bien que la pièce distale (1) soit d'un diamètre supérieur à celui de la section de la défectuosité, le passage de ladite pièce distale (1) à travers la défectuosité ne présente aucun problème. Pour s'en convaincre, il suffit de se rappeler qu'un bouton de chemise passe sans problème à travers la boutonnière bien que la section de cette dernière soit inférieure à celle du bouton.The rod (6) is then actuated so as to introduce the distal part (1) into the left atrium through the defect (see FIG. 6b). Although the distal part (1) is of a diameter greater than that of the section of the defect, the passage of said distal part (1) through the defect presents no problem. For s' proof, just remember that a shirt button passes smoothly through that section lapel latter is lower than the button.
La pièce distale est placée contre les bords de la défectuosité. Son bon positionnement est vérifié par échographie transoesophagienne.The distal part is placed against the edges of the defect. Its correct positioning is verified by transesophageal ultrasound.
La pièce proximale (3) est poussée par le manchon en direction de la pièce distale (1 ) tout en maintenant cette dernière plaquée contre les bords de la défectuosité de sorte à permettre la fixation des deux pièces par encliquetage (voir figure 6c).The proximal part (3) is pushed by the sleeve in the direction of the distal part (1) while keeping the latter pressed against the edges of the defect so as to allow the fixing of the two parts by snap-fastening (see FIG. 6c).
La tige (6) est dévissée et retirée avec le manchon (voir figure 6d). la bourse serrée et liée de façon à fermer l'orifice auriculaire. La présente invention a donc le mérite de présenter plusieurs avantages par rapport à l'état de la technique : L'emploi et le contrôle de mise en place du dispositif d'occlusion sont plus aisés, la grande rigidité du dispositif d'occlusion lui assure une fixation excellente et de longue durée, la précision du positionnement est facilitée par des instruments relativement courts et rigides ou semi-rigides. Comparé aux techniques de cathétérisme de l'art antérieur, il n'y a pas de manipulation des vaisseaux périphériques ni de passages répétés de cathéter dans les vaisseaux intermédiaires entre le site d'introduction des instruments et de la défectuosité elle-même.The rod (6) is unscrewed and removed with the sleeve (see Figure 6d). tight purse and bound so as to close the ear hole. The present invention therefore has the merit of presenting several advantages over the prior art: The use and control of implementation of the occlusion device are easier, the rigidity of the occlusion device ensures excellent and long-lasting fixation, positioning accuracy is facilitated by relatively short and rigid or semi-rigid instruments. Compared to catheterization techniques of the prior art, there 's no manipulation of peripheral vessels or repeated passage of the catheter in the intermediate vessels between the site of introduction of the instruments and the defect itself.
Les coûts de fabrication de l'objet de la présente invention sont en outre considérablement réduits. The manufacturing costs of the object of the present invention are also significantly reduced.

Claims

RevendicationsClaims
1 Dispositif de chirurgie pour l'occlusion d'une défectuosité telle qu une communication1 A surgery for occlusion of a defect such that a communication
^ înteraunculaire. caractérisé en ce qu'il est constitue d'une pièce distale (1) de surface relativ ement rigide, sensiblement plane, voire légèrement courbée, et supérieure a la section de la défectuosité, ladite pièce distale (1 ) étant munie de moyens (2) pour la rendre solidaire a un instrument d'une pièce proximale (3) de surface relativement rigide, sensiblement plane, voire 10 légèrement courbée, et supérieure à la section de la défectuosité, ladite pièce proximale (3) étant munie de moyens (4) pour la rendre solidaire au dit instrument Les deux pièces sont munies chacune d au moins un mo en de fixation (8.9) permettant de les rendre solidaires l'une par rapport a l'autre ^ înteraunulaire. characterized in that it comprises a distal part (1) surface relativ ely rigid, substantially planar or slightly curved, and greater than the section of the defect, said distal part (1) being provided with means (2 ) to make it integral with a instrument of a proximal part (3) of relatively rigid, substantially planar, or even 10 slightly curved, and greater than the section of the defect, said proximal part (3) being provided with means (4 ) to make integral to said instrument the two parts are each provided with at least one mo attachment (8.9) to make them integral one by al report other
\ ^ 2 Dispositif de chirurgie selon la revendication 1 , caractérisé en ce que les mov ens (2) pour rendre la pièce distale (1) solidaire à l'instrument forment une seule pièce (2.8) avec au moins un moyen de fixation (8)\ ^ 2 A surgery according to Claim 1, characterized in that the mov ens (2) to make the distal part (1) secured to the instrument are in one piece (2.8) with at least one fastening means (8 )
3 Dispositif de chirurgie selon la revendication 1 ou 2. caractérisé en ce que les moyens 0 (4) pour rendre la pièce proximale (3) solidaire a l'instrument forment une seule pièce3 A surgery according to Claim 1 or 2. characterized in that the means 0 (4) to make the proximal part (3) integral al instrument are in one piece
(4,9) avec au moins un moyen de fixation (9)(4,9) with at least one fixing means (9)
4 Dispositif de chirurgie selon l'une quelconque des rev endications précédentes caractérisé en ce que ledit moyen de fixation (8.9) est un dispositif d'enc quetage4 A surgical instrument according to one of the preceding rev endications characterized in that said fastening means (8.9) is a device for enc ging
2525
5 Dispositif de chirurgie selon l'une quelconque des revendications précédentes caractérisé en ce que les pièces distale ( 1 ) et proximale (3) sont de forme sensiblement circulaire5 A surgical instrument according to one of the preceding claims characterized in that the distal parts (1) and proximal (3) are substantially circular in shape
"0 6 Dispositif de chirurgie selon l'une quelconque des rev endications 1 a 5, caractérisé en ce que la pièce distale (1) présente une surface externe opposée a la pièce proximale (3) qui est de forme légèrement convexe 7 Dispositif de chirurgie selon l'une quelconque des revendications précédentes, caractérisé en ce que la pièce distale (1 ) est munie d'une bordure légèrement recourbée à sa périphérie."0 6 Surgery device according to any one of claims 1 to 5, characterized in that the distal part (1) has an external surface opposite the proximal part (3) which is slightly convex in shape 7 A surgical instrument according to one of the preceding claims, characterized in that the distal part (1) is provided with a slightly curved on its periphery edge.
8 Dispositif de chirurgie selon l'une quelconque des revendications précédentes. caractérisé en ce que la périphérie de la pièce proximale (3) et'ou de la pièce distale ( 1 ) présente un degré de rigidité supérieur à la surface restante de la pièce.8 A surgical instrument according to one of the preceding claims. characterized in that the periphery of the proximal part (3) and the distal part (1) has a degree of rigidity greater than the remaining surface of the part.
9. Dispositif de chirurgie selon la revendication 8, caractérisé en ce que la surface restante de la pièce est constituée d'une membrane.9. A surgical instrument according to claim 8, characterized in that the remaining surface of the part consists of a membrane.
10 Dispositif de chirurgie selon l'une quelconque des revendications précédentes, caractérisé en ce que la pièce proximale (3) et la pièce distale ( 1 ) sont munies d'au moins un orifice.10 A surgical instrument according to any one of the preceding claims, characterized in that the proximal part (3) and the distal part (1) are provided with at least one orifice.
1 1. Instrument de chirurgie permettant d'utiliser le dispositif de l'une quelconque des revendications précédentes, caractérisé en ce qu'il est constitué : d'une tige (6) munie à son extrémité distale de moyens (7) pour la rendre solidaire à la pièce distale (1) - d'un manchon (5), à l'intérieur duquel la tige (6) peut se déplacer, muni à son extrémité distale de moyens (I I) pour le rendre solidaire au moins en direction de l'extrémité distale de la tige (6) La tige (6) et le manchon (5) étant munis de moyens de saisie à leurs extrémités proximales respectives.1 1. Instrument for surgery for using the device of any one of the preceding claims, characterized in that it comprises: a rod (6) provided at its distal end means (7) to make secured to the distal part (1) - a sleeve (5), within which the rod (6) is displaceable, provided at its distal end means (II) for making it integral at least in the direction of the distal end of the rod (6) rod (6) and the sleeve (5) being provided with gripping means at their respective proximal ends.
12. Instrument de chirurgie selon la revendication 1 1, caractérisé en ce que les moyens de solidarisation de l'extrémité distale (1 1) du manchon (5) sont constitués d'un poussoir. 12. A surgical instrument according to claim 1 1, characterized in that the means for securing the distal end (1 1) of the sleeve (5) consist of a pusher.
PCT/CH1999/000058 1998-02-10 1999-02-05 Surgical device for occlusion of defects WO1999040849A1 (en)

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AU22617/99A AU2261799A (en) 1998-02-10 1999-02-05 Surgical device for occlusion of defects
EP99902484A EP1054628A1 (en) 1998-02-10 1999-02-05 Surgical device for occlusion of defects

Applications Claiming Priority (2)

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CH33098A CH693017A5 (en) 1998-02-10 1998-02-10 surgical device occlusion defects.
CH330/98 1998-02-10

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EP1054628A1 (en) 2000-11-29
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