EP1054628A1 - Vorrichtung zum schliessen eines gewebedefektes - Google Patents

Vorrichtung zum schliessen eines gewebedefektes

Info

Publication number
EP1054628A1
EP1054628A1 EP99902484A EP99902484A EP1054628A1 EP 1054628 A1 EP1054628 A1 EP 1054628A1 EP 99902484 A EP99902484 A EP 99902484A EP 99902484 A EP99902484 A EP 99902484A EP 1054628 A1 EP1054628 A1 EP 1054628A1
Authority
EP
European Patent Office
Prior art keywords
distal
proximal
integral
defect
surgical instrument
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Withdrawn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
EP99902484A
Other languages
English (en)
French (fr)
Inventor
Hendrik Tevaearai
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of EP1054628A1 publication Critical patent/EP1054628A1/de
Withdrawn legal-status Critical Current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
    • A61B17/0057—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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (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)
EP99902484A 1998-02-10 1999-02-05 Vorrichtung zum schliessen eines gewebedefektes Withdrawn EP1054628A1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CH33098A CH693017A5 (fr) 1998-02-10 1998-02-10 Dispositif chirurgical d'occlusion de défectuosités.
CH33098 1998-02-10
PCT/CH1999/000058 WO1999040849A1 (fr) 1998-02-10 1999-02-05 Dispositif chirurgical d'occlusion de defectuosites

Publications (1)

Publication Number Publication Date
EP1054628A1 true EP1054628A1 (de) 2000-11-29

Family

ID=4184566

Family Applications (1)

Application Number Title Priority Date Filing Date
EP99902484A Withdrawn EP1054628A1 (de) 1998-02-10 1999-02-05 Vorrichtung zum schliessen eines gewebedefektes

Country Status (4)

Country Link
EP (1) EP1054628A1 (de)
AU (1) AU2261799A (de)
CH (1) CH693017A5 (de)
WO (1) WO1999040849A1 (de)

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Also Published As

Publication number Publication date
WO1999040849A1 (fr) 1999-08-19
CH693017A5 (fr) 2003-01-31
AU2261799A (en) 1999-08-30

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