WO2016087061A1 - Occludeur multi-flexible pour fermeture de défauts pfo et asd et fabrication de celui-ci - Google Patents

Occludeur multi-flexible pour fermeture de défauts pfo et asd et fabrication de celui-ci Download PDF

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Publication number
WO2016087061A1
WO2016087061A1 PCT/EP2015/068810 EP2015068810W WO2016087061A1 WO 2016087061 A1 WO2016087061 A1 WO 2016087061A1 EP 2015068810 W EP2015068810 W EP 2015068810W WO 2016087061 A1 WO2016087061 A1 WO 2016087061A1
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WIPO (PCT)
Prior art keywords
braid
occluder
distal
threads
proximal
Prior art date
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PCT/EP2015/068810
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German (de)
English (en)
Inventor
Martin Dauner
Michael Doser
Markus Milwich
Friedrich Moszner
Norbert Moszner
Robert Moszner
Sven Oberhoffner
Susanne Schneider
Dagmar Yilmaz
Original Assignee
Acoredis Gmbh
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Publication of WO2016087061A1 publication Critical patent/WO2016087061A1/fr

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    • 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
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526—Methods of manufacturing
    • 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
    • A61B2017/00592—Elastic or resilient implements
    • 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
    • A61B2017/00597—Implements comprising a membrane
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • 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
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/16—Materials with shape-memory or superelastic properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/36—Materials or treatment for tissue regeneration for embolization or occlusion, e.g. vaso-occlusive compositions or devices

Definitions

  • Multifunctional occluder for occluding PFO and ASD defects and its
  • the present invention relates to a flexible intravascular occluder for placement in otherwise difficult to reach defect sites in the human heart by minimally invasive treatment methods via the use of catheter technology, such as occluding holes (shunts) in the area of the atrial septum between the two Atria, the atrium-septal defect (ASD), the patent foramen ovale (PFO), and other applications.
  • catheter technology such as occluding holes (shunts) in the area of the atrial septum between the two Atria, the atrium-septal defect (ASD), the patent foramen ovale (PFO), and other applications.
  • the previously established occlusion devices for occluding vascular heart defects are usually made of a rotationally symmetrical mesh of one or more thin metal threads / wires.
  • such Occluder usually has a predetermined form (permanent output form), which is achieved after the production of Occluders.
  • a predetermined form permanent output form
  • insertion of the occluder into the body of a patient by means of a catheter results in a second pre-definable shape (temporary shape), wherein the distal and proximal retention area are formed as discs and in the central region (defect area) has a waist.
  • nonwovens are additionally used in the two discs to seal off the blood stream.
  • more fleeces can be inserted in the waist for sealing.
  • polyesters such as polyethylene terephthalate (PET) and similar polymers have proven successful.
  • EP 2 014 239 A2 and EP 1 955 DE 10 2005 053 958 A1 discloses a bioresorbable medical self-expandable occluder for the treatment of defects in the heart of a patient, the occluder consisting entirely of a shape memory polymer composition.
  • the occluder has a permanent initial shape.
  • a temporary shape results and in the implanted state of the occluder, the occluder tries to reach the permanent initial shape again, which in practice succeeds only incompletely.
  • Another bioresorbable occlusive device is known by the term “Chinese lantern” (WO 2011/075088) .
  • This device is also characterized by a double-disc design, in which a bipartite spinal scaffold has been selected, which consists distally of polycaprolactone (PCL) struts and proximally Polylactide-PCL copolymer struts spanned by a PCL membrane.
  • PCL polycaprolactone
  • the listed bioresorbable Occiusionssystemen has in common that they are initially after their implantation as a closure device for the diagnosed Atriumseptumsde Stamm serve. These include self-centering in the defect site and optimal sealing of the shunt. In addition, they form a kind of temporary carrier material bridge for the onset and most extensive tissue attachment. If this endothelialization is largely completed, these temporary implants are completely split by the body's own reactions into their harmless subunits and these in turn degraded by known metabolic processes in the body. As a result, these
  • bioresorbable Occiuder are usually similar to the metallic Occuuder also listed from a rotationally symmetrical braid body with permanently crossing threads or wires, which leads in part to the fact that these Occiuder more or less in both the PFO slot and ASD defect stretch or bulge and thus causes only insufficient sealing of the defect and on the other hand results from the relatively simple braid structures a poor grip in the defect. As a result, thrombi may form on the edges of the bulging occlusion, triggering strokes and, if necessary, infarcts during embolization. Furthermore, important properties, such as a good lubricity in an adapted lock size, hardly feasible.
  • the object of the invention is therefore to provide a functional Occuder, which forms flat in the defect without side effects, such as bulging, stretching or "Co bra'- effect and thus optimally adapted to the Vorschseptum.
  • the Occiuder should show optimal Schleustician.
  • This object of the invention is achieved by an occluder according to claim 1. Advantageous embodiments can be found in the dependent claims.
  • the present invention according to claim 1 relates to a multifilament or preferably of monofilament thread material, which may be produced either of metallic or polymeric nature and in particular of biodegradable plastics, molded base body which is produced by a multiflexible braid according to the invention, suitable intermediate stages being suitable for forming and heat treatment processes are used in such a way that essentially Chen a suitable final shape is achieved with a rotationally symmetric disc as a proximal retention area, a rotationally symmetrical distal disc and an approximately cylindrical ridge between the two discs.
  • a step of the deformation and heat treatment process initially comprises the proper feeding of the braid main body into a device which makes up at least part of the later final shape.
  • This tool-bound forming and heat treatment process can be realized several times in succession until the device according to the invention is formed.
  • sub-steps can be combined as desired with the aim of minimizing the total number of steps.
  • hot air it is possible to carry out 3 to 6 heat treatment steps using suitable forming and heat treatment processes. when using tempered salt baths 10 to 12 heat treatment steps are possible.
  • the core of the invention is that the multiflexible braid is not, as before, a fundamentally homogeneously structured braiding, but in certain areas, the braid structure is adapted so that the derived mechanical properties in conjunction with a suitable heat treatment process always exactly the desired final shape, or In effect, the final position is reached, which means that the occlusion device returns to its original initial shape extremely flat in the defect, without stretching and bulging in contrast to the mesh occlusion State of the art.
  • the Occluderendformen as possible for a large number of different defect morphologies similar good and optimal properties with respect to a flat final shape (initial shape) are relevant.
  • the flexible braid according to the invention differs from known embodiments in particular in that the occluders used do not stretch or bulge in the defect after the interventional implantation procedure has been completed. This also means that in the ASD occluders an occurrence of the so-called "Cobra" effect is not possible
  • the embodiments according to the invention can be made of metallic materials, plastics, including bioresorbable substances.
  • the present invention also covers in such embodiments with bioresorbable material.
  • Fig. 1 yes) a spatial schematic representation of the side view of a
  • Braiding machine for producing the inventive multiflexible braid body consisting of open and closed braid portions
  • Fig. 1 (b) is a schematic plan view and partial view of the braiding machine of Fig. 1 (a);
  • FIG. 2 is a schematic plan view of the braiding head with illustration of the braiding head.
  • FIG. 3 shows a schematic illustration of a preferred further embodiment of a multiflexed braid according to the invention, showing the thread pattern for the multiflex braiding in the area of the braiding head according to FIG. 1 (ab) but with two staggered rows Guide pins;
  • FIG. 4 shows a round table with a braided bobbin and carrier and drive plate for the braiding machine according to the multiflex braiding according to FIG. 1 (a-b);
  • FIG. 5 shows a schematic representation of a preferred further embodiment according to the invention of the multiflexed braid in the region of the braiding head with woven-in draw-off threads in the center;
  • FIG. 6 is a further schematic representation of a preferred embodiment of a multiflex braid according to the invention in the region of the braiding head with braided withdrawal threads off-center;
  • FIG. 7 is a schematic representation of a preferred first embodiment of a three-dimensional view of the multiflex main body with a woven-in trigger
  • Fig. 8 (a) is a schematic view of a preferred first embodiment of a multiflexed uniform occluder according to the invention with a woven-in hood in plan view;
  • Fig. 8 (b) is a schematic side view of a preferred first embodiment of a multiflexed uniform occluder according to the present invention shown in Fig. 8 (a);
  • FIG. 9 (a) is a schematic representation of a preferred further embodiment of a Multiflex PFO-Occluders according to the invention in the expanded state with woven-in deduction in plan view,
  • FIG. 9 (b) shows a schematic illustration of a preferred further embodiment of a multiflex PFO occluder according to the invention according to FIG. 9 (a) in the expanded state in side view,
  • FIG. 10 (a) shows a schematic illustration of a preferred further embodiment of a multiflex ASD occluder according to the invention in the expanded state with a woven-in deduction in plan view
  • FIG. 10 (b) a schematic representation of a preferred further embodiment of a multiflex ASD occluder according to the invention according to FIG. 10 (a) in the expanded state in side view,
  • 11 (a) shows a schematic representation of a preferred further embodiment of a multiflex PFO occluder according to the invention in the expanded state, consisting of a multiflexible braid main body of open and closed braid parts without any deduction in plan view
  • 11 (b) shows a schematic illustration of a preferred further embodiment of a multiflex PFO occluder according to the invention according to FIG. 11 (a) in the expanded state in side view
  • FIG. 11 (a) shows a schematic representation of a preferred further embodiment of a multiflex PFO occluder according to the invention in the expanded state, consisting of a multiflexible braid main body of open and closed braid parts without any deduction in plan view
  • 11 (b) shows a schematic illustration of a preferred further embodiment of a multiflex PFO occluder according to the invention according to FIG. 11 (a) in the expanded state in side view
  • FIG. 12 (a) shows a schematic representation of a preferred further embodiment of a multiflex ASD occluder according to the invention in the expanded state, consisting of a multiflexible braid main body of open and closed braid parts without any deduction in plan view,
  • FIG. 12 (b) a schematic representation of a preferred further embodiment of a multiflex ASD occluder according to the invention according to FIG. 12 (a) in the expanded state in side view, FIG.
  • FIG. 13 (a) is a schematic detail view in section for a subsequently introduced trigger mechanism for a further preferred embodiment of a Multiflex PFO Occluders according to the invention of FIG. 11 (a-b) or ASD occluders according to FIG. 12 (a-b),
  • Fig. 13 (b) is a schematic detail view in section of a subsequently introduced trigger mechanism according to Fig. 13 (a) in operation; right pull rope to stop in the ball coupling,
  • Fig. 13 (c) is a schematic detail view in section for a retrofitted trigger mechanism of FIG. 13 (a) with retracted lock and
  • FIG. 13 (d) is a schematic detail view in a sectional view of a subsequently introduced trigger mechanism according to FIG. 13 (a) in the end position after uncoupled insertion system.
  • Fig. 1 (ab) shows a schematic spatial representation of the side view of a rotationally symmetrical braiding machine 35 for producing a first preferred embodiment of Occluders (Occiusionsinstrument) 1 of FIG. 9 (ab),
  • the braiding machine 35 is constructed as follows: On the rotary table 15th For example, 40 circular support and drive plates 7 are mounted on the outer edge. On each carrier and drive plate are four receptacles 6 for each one Flechtblöppel inside 8 and outside 9. On each carrier and drive plate are exactly two braided beaters, one each for inside 8 and outside 9. Above the braiding machine 35 is a braided 10 with a central through hole 12, which is circumferentially equipped with guide pins 11 at the edge.
  • a braid body 29 with a multiflexible braid portion 3 with open 5 and closed braid segments 4 all threads 2 of the existing braids 8, 9 are included. The procedure is as follows:
  • Each of a braid and drive plate 7 is stretched by a braided bobbin 8, 9 on the braiding 10 between the guide pins 11 through exactly to the opposite braided bobbin 8, 9 on the associated support plate 7 each have a thread 2.
  • the thread 2 is guided from the braiding beater inside 8 to the braiding bobbin outside 9 on the opposite side of the braiding machine 35.
  • the filaments 2 are held on each side by a filament tensioner 23.
  • the thread 2 is returned from the clapper 8 via a guide pin 11 located at the edge of the braiding head 10 to the clapper 9 of the same carrier and drive plate 7.
  • a braid body 29 of FIG. 7 now mutually all present clapper 8, 9 are covered with threads, so that in a closed braid 4 each an open braid 5 follows and that except for four clapper 8, 9, which for the trigger mechanism 13th or 14 (here take-off mechanism 13 with four threads 2) are required.
  • the withdrawal threads 2 are placed after a central deduction 13 as follows:
  • Fig. 2 shows the complete coverage of the braiding head 10 for a multifilament braid with open 5 and closed braid portions 4.
  • the threads 2 in the closed cycle 16 pass through the braiding head 10 and the threads 2 in the open cycle 17 are each returned to a guide pin 11 to the respective support plate 7.
  • a flattening at the distal end 27, which in turn allows improved sliding properties in the lock 20 occurs.
  • FIG. 3 are equipped with a corresponding braiding 10, two concentric circles with corresponding guide pins, resulting in an improvement of the molding properties, eg. B. causes even better flattening of the distal end 27 of the braid body 29 and also significantly improves the sliding properties in the lock.
  • the braiding main body 29 according to the invention produced according to FIG. 7 was a central trigger of FIG. 5 used.
  • FIG. 6 shows a schematic illustration of the design of the braiding head 10 for interlaced eccentric withdrawal threads, which can produce a more stable basic shape for an occlusion device 1.
  • Fig. 8 (a-b) Fig. 9 (a-b) and Fig. 10 (a-b) can be used for specially suitable embodiments of metal filaments, such.
  • occluders can also be made from suitable bioresorbable materials.
  • monofilament or multifilament ment threads 2 (as a replacement for the metallic wires) made of bioresorbable polymer and bioresorbable patches (nonwovens) 45 the following specifications:
  • Absorbable copolymer formed from 70% by weight to 97% by weight L-lactide and 3% by weight to 30% by weight glycolide, preferably 80% by weight to 95% by weight L-lactide and 5% by weight % to 20% by weight of glycolide and particularly preferably 88% to 93% by weight of L-lactide and 7% by weight to 12% by weight of glycolide.
  • the polymer may be a random copolymer or a block copolymer, with a random copolymer being preferred.
  • the polymer in the untreated state has a residual monomer content of between 3% by weight and 7% by weight of L-lactide.
  • the residual monomer content can be reduced by appropriate processes under reduced pressure with temperature.
  • the glass transition point of the polymer is between 48 ° C. and 59 ° C. and, in addition to the composition of the polymer, is dependent on the residual monomer content.
  • the polymer In the rapidly cooled from the melt state, the polymer is substantially amorphous (enthalpy of fusion ⁇ 8 J / g), but crystallizable at temperatures between 80 ° C and 140 ° C and preferably between 100 ° C and 120 ° C and stress-induced above its glass transition point example by hiding a thread-like material.
  • Filamentary structures 2 and nonwovens 45 can be recovered from the polymer either by melt-making or solution, melt-making being preferred.
  • the thread-like structures can be either multifilament or monofilament, with monofilament structures preferably being used for the production of the main body 29 of the occluder 1.
  • the diameter of the monofilaments 2 produced from the polymer is between 0.08 mm and 0.50 mm, preferably between 0.10 mm and 0.40 mm and particularly preferably between 0.12 mm and 0.25 mm.
  • the drawn monofilaments 2 have a linear strength between 300 N / mm 2 and 600 N / mm 2 .
  • the drawn monofilaments 2 have a flexural modulus (bending angle 30 °, clamping length 5 mm, 22 ° C) between 4,000 N / mm 2 and 10,000 N / mm 2 and more preferably between 6,000 N / mm 2 and 10,000 N / mm 2 , at the use as Occluder body 29 to provide the necessary erection force.
  • a flexural modulus bending angle 30 °, clamping length 5 mm, 22 ° C
  • the untreated monofilaments 2 After extrusion and drawing, the untreated monofilaments 2 have a residual monomer content between 3% by weight and 7% by weight.
  • the monofilaments 2 may either be partially de-monomerized or preferably almost completely demonomerized by a post-treatment step under reduced pressure. Alternatively, the demonomerization can be achieved by C0 2 extraction.
  • Monofilaments having a monomer content of ⁇ 0.2% by weight L-lactide have a prolonged degradation period of 8 weeks to 32 weeks, preferably between 12 weeks and 24 weeks and more preferably between 15 and 20 weeks. This allows a complete epithelialization of the skeleton before the occurrence of mechanical fragments on the one hand and avoids an unnecessarily long irritation of the tissue by the device on the other.
  • the threads 2 of the withdrawal mechanism 44 are made from bioresorbable polymer, but not necessarily from the LG copolymers described herein.
  • Other polymer variants for the Switzerlandseile are homopolymers of polylactide (PLLA), PDO and polycaprolactone and their copolymers with glycolide as a comonomer, moreover, polymers of hydroxycarboxylic acids such.
  • polyhydroxybutyric acid eg., P3H B and P4H B find use.
  • the pull rope mechanism may consist of several monofilaments, of bundled monofilaments, of bundled monofilaments with enveloping matrix (Pseudomonofil) or of a monofilament.
  • the device for grasping the 20-100 monofilaments of the base body at its proximal end and the coupling for coupling to the insertion aid is preferably formed of bioresorbable polymer, but may alternatively be made of resorbable magnesium, zinc or iron alloys that degrade with hydrogen evolution or from be formed of permanent gold / stainless steel. The latter would then simultaneously serve as an X-ray marker at the proximal end. Another metallic X-ray marker on the distal shield could serve to fix the pull rope or the pulling system at this point, if the pull rope is not integrated into the mesh of the main body.
  • X-ray labeling can also be achieved by filling the polymer with a radiopaque additive (eg, barium sulfate or bismuth oxide), e.g. B. be achieved during the extrusion to monofilament, but this requires at least fill levels of approx. 30% by weight.
  • a radiopaque additive e.g, barium sulfate or bismuth oxide
  • B. be achieved during the extrusion to monofilament, but this requires at least fill levels of approx. 30% by weight.
  • the particles of the additive would be released after absorption of the polymer, but this might be justified due to the epithelialization.
  • An X-ray mark can also be applied by spraying or punctually dripping a liquid phase containing the X-ray marker either dissolved or dispersed.
  • the bioresorbable occluder is sterilized in its established permanent form (EO, alternatively: gamma or beta irradiation, here shortening of the degradation profile, plasma sterilization) and stored, the introduction into the sluice by means of an auxiliary device to be described directly before implantation.
  • EO established permanent form
  • beta irradiation here shortening of the degradation profile, plasma sterilization
  • the inner surface of the lock (be Preferably) or the Occluder- base body with a biocompatible lubricant (eg salts of stearic acid) or a low-viscosity polymer coating (carboxymethylcellulose (CMC), polyethylene oxide (PEO) or polyvinyl alcohol (PVA)) to be coated.
  • a biocompatible lubricant eg salts of stearic acid
  • a low-viscosity polymer coating (carboxymethylcellulose (CMC), polyethylene oxide (PEO) or polyvinyl alcohol (PVA)
  • the patch or patches can either be produced separately or preferably directly on the screens of the occluder by means of melt-blow technology or fiber spraying, which has the advantage that the sewing on of the patches to the main body is dispensed with.
  • the separately produced patches may be attached either to the outside or the inside of the screens, with attachment to the inside being preferred because of the introduction through the sluice.
  • the fixation of the patches on the base body can be done either by a continuous seam with resorbable suture material or by selective gluing or welding to the base body.
  • the resorbable suture advantageously has a degradation time of between 30 and 60 days and is completely absorbed no later than after 180 days, preferably after 90 days (note: if the degradation duration of the monofilament suture is too short, fragments could form before epithelialization takes place).
  • Nonwovens (patches) 45 can be made from the polymer either by melt-blown technology, by the spunbond process, by the consolidation of staple fibers, or by a combination of these technologies from the melt.
  • Nonwoven fabrics may be made from solution by electrospinning, centrifugal spinning, a fiber spray process, or combinations of these techniques.
  • the fiber diameter range is preferably between 10 ⁇ and 0.1 ⁇ , preferably between 5 ⁇ and 0.5 ⁇ and more preferably between 2 ⁇ and 0.5 ⁇ .
  • the nonwovens After densification and thus after increasing the mechanical stability of the nonwovens, these have a thickness between 25 ⁇ and 100 ⁇ and preferably between 40 and 60 ⁇ on.
  • the compaction can be achieved either by calendering, by pressing, by needling or by water jet compression.
  • the fleece like the monofilaments, can be almost completely demonomerized.
  • the degradation profile of the nonwovens essentially corresponds to that of the monofilaments 2.
  • the patch 45 may also consist of a film or membrane and preferably of a unidirectionally or bidirectionally stretched film or membrane of the resorbable polymer, wherein in the case of a film by small punched or laser cutting a large number of small breakthroughs arise by narrow webs from each other are delimited.
  • Films can be made by doctoring a polymer solution or by extrusion, membranes can be made from solution by the phase inversion technique.
  • the patch may be a textile and preferably knitted structure of fine threads.
  • Such preferred embodiments of Multiflex braids 29 according to the invention according to the specifications of FIGS. 2, Fig. 3, Fig. 5 and 6 with open 5 and closed mesh parts 4 can also be finished without any deductions 13 or 14.
  • subsequent traction ropes or an equivalent traction system 44 can be introduced here ( Figure 13 (ad).)
  • the PFO occluders 38 of FIG. 11 (ab) and ASD Occluder 39 of FIG. 12 (ab) differ from the external appearance and the function to be secured then no longer from the in Figs. 9 (ab) and Fig. 10 (ab) PFO Occluder 38 shown or ASD Occluder 39.
  • the pull rope mechanism may consist of several monofilaments, of bundled monofilaments, of bundled monofilaments with enveloping matrix (Pseudomonofil) or of a monofilament.
  • the traction cable can be provided with barbs whose tips point towards the distal side, in particular in the region near the distal shield, which, after the Occluder has been set up, anchor to the lead-through element at the proximal Occlunder end by pulling the traction cables and thus fix the erected form.
  • the pull cable could also conically thicken to the distal end and be clamped in the proximal feedthrough element.
  • a thickening of resorbable polymer can be attached to or on the pull rope (s), which is configured either annular or conical or spherical.
  • a traction system 44 may be formed of either an elastomeric resorbable thread or an undrawn thread.
  • the elastomeric thread When introducing the occluder through the sluice, the elastomeric thread would lengthen and after ejection of the occluder its erect form by contraction. The unstretched thread would stretch during insertion and set up after ejection under shrink the Occluder. Shrinkage to the initial length before stretching is time-limited and can be achieved almost exclusively by means of block copolymers of the type A-B-A, where block B represents the soft segment and block A represents a hard segment. Both variants, however, increase the friction force in the lock, since already here the raising force acts.
  • a monofilament of the same material composition as the copolymer for the braid body 29 is used for the withdrawal system 44.
  • the thread 2 for the traction system 44 is selected by the strength so that corresponding tensile forces can be absorbed and the interventional implantation procedure is not hindered.
  • Fig. 13 (a) the occlusion instrument is already in final position.
  • FIG. 13 (b) the right-hand thread of the tensioning system 44 has already been released and firmly anchored in the ball coupling 42 with a thickening at the end.
  • the pull rope on the left side secures the firm hold in the ball coupling.
  • both tension cables of the tension system 44 are firmly anchored and support a flat end position of the implanted Occluders 1 in Vorhuntseptum.
  • the generative manufacturing processes are methods for the rapid and cost-effective production of models, moldings or prototypes, based on the computer-aided 3D data (usually STL files) of informal (eg liquids or powders) or shape-neutral (eg, tape or wire,), starting components are made by physico-chemical processes.
  • the desired geometry is produced by joining together volume elements.
  • the shaped body is composed of individual layers.
  • the selected manufacturing process not only produces the geometry but also simultaneously creates the material properties. Accordingly, the generative methods for the production of occlusion instruments are particularly suitable and two methods are particularly suitable: on the one hand stereolithography (SL) and on the other hand printing (2D or 3D).
  • layered liquid resin monomers are cured by photopolymerization and hardening is carried out by irradiation by means of a laser (laser scanner method) or high-performance beamer or UV lamp (mask method).
  • the molding is made by solidification due to photopolymerization of commercially available monomers which may contain other additives and fillers.
  • Suitable polymerizable resin monomers are, in particular, mixtures of monofunctional or polyfunctional acrylates or methacrylates which, when irradiated in the presence of suitable free-radical-forming photoinitiators, such as, for example, Dimethylbenzilketal, acyl or (bisacylphosphine oxides or mixtures of camphorquinone and tertiary amines, for example N, N-dimethyl-p-toluidine, N, N-dihydroxyethyl-p-toluidine, 4-dimethylaminobenzoic acid ethyl ester, rapidly by free-radical polymerization
  • suitable free-radical-forming photoinitiators such as, for example, Dimethylbenzilketal, acyl or (bisacylphosphine oxides or mixtures of camphorquinone and tertiary amines, for example N, N-dimethyl-p-toluidine, N, N-dihydroxyethyl-
  • cationic polymerization resins can be cationically ring-opening polymerizable monomers such.
  • Examples are: 2-methylene-1, 4,6-trioxaspiro [2.2] nonane, 3,9-dimethylene-1, 5,7, 1-tetraoxaspiro [5,5] undecane, 2-methylene-1,3-dioxepane, 2-phenyl-4-methylene-1,3-dioxolane, bisphenol A diglycidyl ether, 3,4- (epoxycyclohexylmethyl-3,4-epoxycyclohexanecarboxylate, bis (3,4-epoxycyclohexylmethyl) adipate, vinylcyclohexene dioxide, 3-ethyl 3-hydroxymethyloxetane, 1, 10-decanediylbis (oxymethylene) bis (3-ethyloxetane) or 3,3- (4-xylylenedioxy) bis (methyl-3-ethyloxetane) Cationic polymerizable resins
  • suitable diaryliodonium salts are 4-o
  • the building material can be applied layer by layer (2D) by means of a print head.
  • the applied material is polymerized the same (Polymer Printing).
  • thermoplastic polymers are used, the solidification takes place by cooling the polymer melt.
  • Most commonly used polymers are polyamide, ABS or polycarbonate, which can be filled up with particles or fibers.
  • 3D printing solid layers are produced by gluing granules together with a binder.

Abstract

L'invention concerne un instrument d'occlusion (1) à usage médical pour le traitement de défauts situés dans le cœur d'un patient, en particulier pour la fermeture de passages anormaux dans des tissus. Ledit occludeur (1) est constitué d'un entrelacement multi-flexible (3) de fils minces (2) qui est composé de segments fermés (4) et de segments ouverts (5), un disque distal ou une zone de retenue distale (24) étant séparée d'un disque proximal ou d'une zone de retenue proximale (25) par un élément de liaison (26), et chacun des disques (24, 25) comportant au moins un insert en non-tissé (patches) (45) qui est nécessaire dans l'élément de liaison (26) pour fermer complètement le shunt. Par une intervention chirurgicale généralement interventionnelle, les deux les zones de retenue (24, 25) viennent en appui sur les deux côtés d'un shunt à fermer dans un septum tandis que l'élément de liaison (26) traverse le shunt. Les fils (2) de l'entrelacement multi-flexible (3) peuvent être réalisés en métal ou en alliages métalliques, comme par exemple le nitinol, en matières plastiques non résorbables choisies dans le groupe des polyesters, des polyamides, des polyoléfines, des polyuréthanes et des oléfines polyhalogénées, ou en matières polymères biorésorbables.
PCT/EP2015/068810 2014-12-04 2015-08-17 Occludeur multi-flexible pour fermeture de défauts pfo et asd et fabrication de celui-ci WO2016087061A1 (fr)

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DE102014018086.7 2014-12-04
DE102014018086.7A DE102014018086A1 (de) 2014-12-04 2014-12-04 Multiflexibler Occluder zum Verschluss von PFO- und ASD-Defekten und dessen Herstellung

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US11337684B2 (en) 2016-12-31 2022-05-24 Lifetech Scientific (Shenzhen) Co. Ltd. Occluder and method for sewing occluder
EP4104772A1 (fr) * 2021-06-15 2022-12-21 St. Jude Medical, Cardiology Division, Inc. Dispositifs de traitement des anomalies vasculaires
RU224429U1 (ru) * 2023-12-28 2024-03-22 Максим Олегович Жульков Самофиксирующийся коннектор для бесшовного формирования анастомоза по типу "конец в бок"

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11337684B2 (en) 2016-12-31 2022-05-24 Lifetech Scientific (Shenzhen) Co. Ltd. Occluder and method for sewing occluder
EP4104772A1 (fr) * 2021-06-15 2022-12-21 St. Jude Medical, Cardiology Division, Inc. Dispositifs de traitement des anomalies vasculaires
RU224429U1 (ru) * 2023-12-28 2024-03-22 Максим Олегович Жульков Самофиксирующийся коннектор для бесшовного формирования анастомоза по типу "конец в бок"

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