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WO1998002112A1 - Gaine filtre extensible a usage chirurgical pour veine cave ou gros vaisseaux sanguins - Google Patents

Gaine filtre extensible a usage chirurgical pour veine cave ou gros vaisseaux sanguins Download PDF

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Publication number
WO1998002112A1
WO1998002112A1 PCT/FR1996/001089 FR9601089W WO9802112A1 WO 1998002112 A1 WO1998002112 A1 WO 1998002112A1 FR 9601089 W FR9601089 W FR 9601089W WO 9802112 A1 WO9802112 A1 WO 9802112A1
Authority
WO
WIPO (PCT)
Prior art keywords
sheath
sheath according
vessel
extensible
elements
Prior art date
Application number
PCT/FR1996/001089
Other languages
English (en)
Inventor
Alain Fouere
Original Assignee
Alain Fouere
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 Alain Fouere filed Critical Alain Fouere
Priority to AU66173/96A priority Critical patent/AU6617396A/en
Priority to PCT/FR1996/001089 priority patent/WO1998002112A1/fr
Publication of WO1998002112A1 publication Critical patent/WO1998002112A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/016—Filters implantable into blood vessels made from wire-like elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/018—Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30317—The prosthesis having different structural features at different locations within the same prosthesis
    • A61F2002/30327—The prosthesis having different structural features at different locations within the same prosthesis differing in diameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/825—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having longitudinal struts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/005—Rosette-shaped, e.g. star-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A—HUMAN NECESSITIES
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    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A61F2230/0069—Three-dimensional shapes cylindrical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • the present invention relates to an extensible filter sheath for surgical use for vena cava or large blood vessels.
  • It is generally intended to filter or reduce the blood flow to avoid certain necrotic tissue damage due to circulatory disorders caused by too high blood pressure, by thrombosis or embolism, and in particular to limit the risks of infarction caused by the obliteration of a myocardial vessel by a clot or a foreign body carried by the blood circulating in the vena cava.
  • the devices used to date generally consist of self-expanding filters formed of fibers 1 (Figure 1) connected by one of their ends and opening into an umbrella when the filter is released once brought to the chosen location.
  • These prostheses are previously compressed to be introduced into a tube mounted at the end of a catheter, then expelled from it once in place, the elasticity of the constituent material ensuring their radial extension.
  • This type of filter has a number of drawbacks. Indeed, it is very difficult to position with precision and, not only does it tend to migrate after its installation, but it often gets in the way at the time of installation. In addition, in most cases, its action must be removed after a certain time, which requires its extraction. Very often this requires a heavy surgical intervention to be able to directly access the vessel concerned.
  • the device according to the present invention eliminates all these drawbacks. Indeed, it makes it possible to obtain filters for blood vessels presenting a zero risk of migration, while facilitating precise positioning as well as easy decommissioning and without operation. These filters can in no case get across the vessel and simultaneously ensure the expansion of the latter thereby facilitating the flow of blood flow. Finally, the installation is carried out through a hole with a diameter substantially smaller than that necessary for existing systems.
  • It consists of a sheath formed by two radially expandable hollow tubular elements, with a semi-rigid self-expanding or malleable lattice wall, interconnected by longitudinal peripheral bars arranged so as to deviate in a cone across the vessel blood to be treated, to form a filtration grid when one of these two elements, the maintenance element undergoes radial expansion, the second expandable element remaining in the compressed state, but being configured to allow its subsequent expansion in order to remove the filtration by completely freeing the passage in the treated vessel.
  • FIG. 1 represents a filter for blood vessels of the type currently used.
  • 2 shows before expansion, side view, a filter sheath according to the invention mounted on an inflatable balloon used to cause the expansion of the holding element
  • Figure 3 shows in the same conditions the sheath after expansion of the 'holding element
  • Figure 4 shows the expansion of the second element to remove the filtering effect
  • Figures 5 and 6 illustrate two alternative embodiments of the filter sheath.
  • the device consists of a tubular sheath 2 formed by a portion of hollow cylinder of circular section, and the wall of which consists of a trellis or grating made of malleable semi-rigid material arranged so as to allow said sheath to extend radially under the effect of internal pressure and to keep the shape thus obtained.
  • the internal pressure is caused for example by means of an inflatable balloon 3 mounted at the end of a catheter 4 according to a known technique.
  • the sheath 2 is subdivided into three elements.
  • the holding element 5 which is the longest in order to prevent any risk of migration, has an expandable trellis structure and has the role of ensuring good attachment of the device to the chosen location inside the vessel, as well as the dilation of the latter.
  • the holding element 5 which is the longest in order to prevent any risk of migration, has an expandable trellis structure and has the role of ensuring good attachment of the device to the chosen location inside the vessel, as well as the dilation of the latter.
  • a second element 6 normally shorter, but with the same structure as the previous one, will remain compressed during installation.
  • the filter element 7 proper consisting of longitudinal peripheral bars 8.
  • the sheath 2 will preferably be in one piece and produced by laser EDM from a block of metal such as stainless steel or tantalum, or by laser engraving or machining of a thin-walled metal tube .
  • the trellis constituting the two expandable elements 5, 6 will for example consist of longitudinal elongated elements connected to each other by annular elements arranged in staggered rows, but may have any configuration allowing an adjustable extension as a function of the pressure applied.
  • the filter bars 8 will advantageously have a width close to 20/10 mm, the width of the elongated elements 9 forming the lattice being of the order of 13/10 mm.
  • the sheath 2 will preferably be manufactured in expanded form, then "crushed" on the inflatable balloon 3.
  • the sheath 2 consists of a central retaining element 5 connected by two sets of filter bars 8 to two expandable terminal elements 6 '(FIG. 6).
  • the sheath 2 is self-expanding and produced in expanded form in a flexible material or with shape memory. For its positioning, it is compressed radially and introduced into a hollow tube of small diameter mounted at the end of a catheter and expelled from said tube by an appropriate means when it is in the chosen location.
  • the expansion of the terminal element (s) (6, 6 ′) is temporarily prevented by virtue of one or more resorbable wires with long resorption time, which allows this or these terminal element (s) to return to their initial shape after a time. more or less long, depending on the number of wires, without any intervention.
  • the free end of the second extensible element 6 (and, where appropriate, that of the other end element 6 ') may be cut at an angle ( figure 5).
  • the sheath 2 may include integrated fastening means, directed radially towards the outside so as to sink into the internal wall of the vessel under the effect of the pressure of the inflatable element 3, thus preventing all possibilities of moving the device.
  • sheath 2 allows it to be used as an anchoring element for a prosthesis tubular, in particular in the case of aneurysm of the abdominal aorta in the vicinity of the departures of the renal arteries. In this case, the entire sheath is expanded
  • the particular structure of the sheath 2 makes it possible to use it as an anchoring element of a tubular vascular prosthesis in the case of aneurysm in the vicinity of venous or arterial diversions, and very particularly for an aneurysm of the abdominal aorta located near departures of the renal arteries.
  • the entire sheath 2 is expanded once brought to the appropriate location, so that the longitudinal peripheral bars 8 are at the location of the branch (s) to allow easy passage of blood, the retaining element 5 being applied against the walls of a healthy part of the vessel to ensure attachment, and the short element 6, oriented towards the aneurysm serving as support for the vascular prosthesis.
  • the junction of the sheath 2 and the prosthesis can be carried out by means of an internal or external cylindrical annular piece or by fixing elements such as hooks, provided for this purpose on the short element 6.
  • the latter will advantageously be covered with a flexible film of synthetic material such as polyurethane, silicone or polyester.
  • the sheaths 2 will advantageously include radio-opaque markers consisting of X-rays, and made up of layers of a heavy metal such as tantalum, titanium or gold deposited by electrolytic means. These layers may have a thickness close to 0.1 mm.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
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Abstract

La présente invention a pour objet une gaine filtre extensible à usage chirurgical pour veine cave ou gros vaisseaux sanguins. Il est constitué d'une gaine (2) formée de deux éléments (5, 6) tubulaires creux extensibles radialement, à paroi semi-rigide auto-extensible ou malléable en treillis, reliés entre eux par des barres périphériques longitudinales disposées de manière à s'écarter en cône en travers du vaisseau sanguin à traiter, pour former une grille de filtration lorsque l'un de ces deux éléments, l'élément de maintien (5) subit une expansion radiale, le second élément expansible demeurant à l'état comprimé, mais étant configuré pour permettre son expansion ultérieure afin de supprimer la filtration en libérant entièrement le passage dans le vaisseau traité. Elle est destinée d'une façon générale à filtrer ou à diminuer le flot sanguin pour éviter certaines lésions nécrotiques des tissus dues à des troubles circulatoires causés par une pression sanguine trop élevée, par thrombose ou par embolie, et en particulier à limiter les risques d'infarctus provoqués par l'oblitération d'un vaisseau du myocarde par un caillot ou un corps étranger véhiculé par le sang circulant dans la veine cave.

Description

GAINE FILTRE EXTENSIBLE A USAGE CHIRURGICAL POUR VEINE CAVE OU GROS VAISSEAUX SANGUINS
La présente invention a pour objet une gaine filtre extensible a usage chirurgical pour veine cave ou gros vaisseaux sanguins .
Elle est destinée d'une façon générale à filtrer ou à diminuer le flot sanguin pour éviter certaines lésions nécrotiques des tissus dues à des troubles circulatoires causés par une pression sanguine trop élevée, par thrombose ou par embolie, et en particulier à limiter les risques d'infarctus provoqués par l'oblitération d'un vaisseau du myocarde par un caillot ou un corps étranger véhiculé par le sang circulant dans la veine cave.
Les dispositifs utilisés à ce jour sont généralement constitués de filtres auto-extensibles formés de fibres 1 (figure 1) reliées par une de leurs extrémités et s 'ouvrant en parapluie lorsque le filtre est libéré une fois amené à l'emplacement choisi. Ces prothèses sont préalablement comprimées pour être introduites dans un tube monté à l'extrémité d'un cathéter, puis chassées hors de celui-ci une fois en place, l'élasticité du matériau constitutif assurant leur extension radiale.
Ce type de filtre présente un certain nombre d'inconvénients. En effet, il est très difficile à positionner avec précision et, non seulement il a tendance à migrer après son installation, mais il se met souvent en travers au moment de la pose. En outre, dans la plupart des cas, son action doit être supprimée au bout d'un certain temps, ce qui impose son extraction. Très souvent cela nécessite une intervention chirurgicale lourde pour pouvoir accéder directement au vaisseau concerné .
Le dispositif selon la présente invention supprime tous ces inconvénients. En effet, il permet d'obtenir des filtres pour vaisseaux sanguins présentant un risque nul de migration, tout en facilitant un positionnement précis ainsi qu'une mise hors service aisée et sans opération. Ces filtres ne peuvent en aucun cas se mettre en travers du vaisseau et assurent en outre simultanément la dilatation de ce dernier facilitant ainsi l'écoulement du flot sanguin. Enfin la mise en place s'exécute à travers un trou de diamètre sensiblement plus faible que celui nécessaire pour les systèmes existants .
Il est constitué d'une gaine formée de deux éléments tubulaires creux extensibles radialement, à paroi semi-rigide auto-extensible ou malléable en treillis, reliés entre eux par des barres périphériques longitudinales disposées de manière à s'écarter en cône en travers du vaisseau sanguin à traiter, pour former une grille de filtration lorsque l'un de ces deux éléments, l'élément de maintien subit une expansion radiale, le second élément expansible demeurant à l'état comprimé, mais étant configuré pour permettre son expansion ultérieure afin de supprimer la filtration en libérant entièrement le passage dans le vaisseau traité.
Sur les dessins schématiques annexés, donnés à titre d'exemples non limitatifs de formes de réalisation de l'objet de l'invention: la figure 1 (déjà citée) représente un filtre pour vaisseaux sanguins du type employé actuellement. la figure 2 représente avant expansion, vue d côté, une gaine filtrante selon l'invention montée sur un ballonnet gonflable utilisé pour provoquer l'expansion de l'élément de maintien, la figure 3 montre dans les mêmes conditions la gaine après expansion de l'élément de maintien, la figure 4 représente l'expansion du second élément pour supprimer l'effet filtrant et les figures 5 et 6 illustrent deux variantes d'exécution de la gaine filtrante.
Le dispositif, figures 2 à 6, est constitué d'une gaine tubulaire 2 formée d'une portion de cylindre creux de section circulaire, et dont la paroi consiste en un treillis ou grillage réalisé en matériau semi-rigide malléable agencé de manière à permettre à ladite gaine de s'étendre radialement sous l'effet d'une pression interne et de garder la forme ainsi obtenue. La pression interne est provoquée par exemple au moyen d'un ballonnet gonflable 3 monté à l'extrémité d'un cathéter 4 selon une technique connue .
La gaine 2 est subdivisée en trois éléments . l'une des extrémités, l'élément de maintien 5, qui est le plus long afin d'interdire tout risque de migration, présente une structure en treillis expansible et a pour rôle d'assurer un bon accrochage du dispositif à l'emplacement choisi à l'intérieur du vaisseau, ainsi que la dilatation de ce dernier. Lors de la pose, seul cet élément est disposé sur le ballonnet 3 pour subir une expansion. A l'autre extrémité, un second élément 6, normalement plus court, mais de même structure que le précédent restera comprimé lors de la mise en place. Entre les deux, l'élément filtrant 7 proprement dit constitué de barres 8 périphériques longitudinales. Lorsque l'élément de maintien est dilaté par le gonflement du ballonnet 3, du fait que le second élément 6 ne subit pas d'expansion, ces barres s'ouvrent en cône en travers du vaisseau sanguin pour former une grille assurant la filtration recherchée (figure 3).
Pour supprimer l'effet du dispositif et libérer entièrement le passage dans le vaisseau traité, il suffit de faire subir au second élément 6 une expansion de la même manière que pour assurer la mise en place de la gaine 2 dans le vaisseau, c'est-à-dire en utilisant ballonnet gonflable 3' monté à l'extrémité d'un cathéter 4, et inséré à l'intérieur de ce second élément, qui est configuré pour le permettre, ce qui élimine la nécessité d'une intervention chirurgicale (figure 4).
La gaine 2 sera de préférence d'une seule pièce et réalisée par électro-érosion laser à partir d'un bloc de métal tel que l'acier inoxydable ou le tantale, ou par gravure ou usinage laser d'un tube métallique à paroi mince. Le treillis constituant les deux éléments expansibles 5, 6 sera par exemple constitué d'éléments allongés longitudinaux reliés entre eux par des éléments annulaires disposés en quinconce, mais pourra présenter toute configuration permettant une extension ajustable en fonction de la pression appliquée.
Les barres filtre 8 auront avantageusement une largeur voisine de 20/10 mm, la largeur des éléments allongés 9 formant le treillis étant de l'ordre de 13/10 mm.
La gaine 2 sera de préférence fabriquée sous forme expansée, puis "écrasée" sur le ballonnet gonflable 3. Selon une variante d'exécution, la gaine 2 est constituée d'un élément de maintien 5 central relié par deux jeux de barres 8 de filtration à deux éléments expansibles terminaux 6' (figure 6).
Selon une autre variante d'exécution, la gaine 2 est auto-extensible et réalisée sous forme expansée dans un matériau flexible ou à mémoire de forme. Pour sa mise en place, elle est comprimée radialement et introduite dans un tube creux de faible diamètre monté à l'extrémité d'un cathéter et chassée dudit tube par un moyen approprié lorsqu'elle se trouve à l'emplacement choisi .
L'expansion du ou des éléments terminaux (6, 6') est empêchée temporairement grâce à un ou plusieurs fils résorbableε à longue durée de résorption, ce qui permet à ce ou ces éléments terminaux de reprendre leur forme initiale au bout d'un temps plus ou moins long, en fonction du nombre de fils, sans aucune intervention.
Dans le but de faciliter les déplacements de la gaine 2 lors de sa mise en place, l'extrémité libre du second élément extensible 6 (et, le cas échéant, celui de 1 ' autre élément terminal 6 ' ) pourra être coupé en biais (figure 5) .
Pour certaines applications , la gaine 2 pourra comporter des moyens d'accrochage intégrés, dirigés radialementε vers l'extérieur de façon à s'enfoncer dans la paroi interne du vaisseau sous l'effet de la pression de l'élément gonflable 3, empêchant ainsi toutes possibilités de déplacement du dispositif.
La structure particulière de la gaine 2 permet de l'utiliser comme élément d'ancrage d'une prothèse tubulaire, en particulier dans le cas d'anévrisme de l'aorte abdominale au voisinage des départs des artères rénales. Dans ce cas, la totalité de la gaine est expansée
La structure particulière de la gaine 2 permet de l'utiliser comme élément d'ancrage d'une prothèse vasculaire tubulaire dans le cas d'anévrisme au voisinage de dérivations veineuses ou artérielles, et tout particulièrement pour un anévrisme de l'aorte abdominale situé près des départs des artères rénales.
Dans ce cas, la totalité de la gaine 2 est expansée une fois amenée à l'emplacement adéquat, de manière à ce que les barres 8 périphériques longitudinales se trouvent à l'emplacement de la ou des dérivations pour permettre un passage facile du sang, l'élément de maintien 5 étant appliqué contre les parois d'une partie saine du vaisseau pour assurer l'accrochage, et l'élément court 6, orienté vers l'anévrisme servant de support à la prothèse vasculaire.
La jonction de la gaine 2 et de la prothèse pourra s'effectuer au moyen d'une pièce annulaire cylindrique interne ou externe ou d'éléments de fixation tels que des crochets, prévus à cet effet sur l'élément court 6.
Afin d'éviter que 1 'endothélium des vaisseaux de pénétrer à l'intérieur de l'élément de maintien 5 à travers les mailles du treillis, celui-ci sera avantageusement recouvert d'un film souple en matériau synthétique tel que polyuréthanne, silicone ou polyester.
Pour faciliter les opérations de mise en place et d'annihilation du filtrage, les gaines 2 comporteront avantageusement des repères radio-opaques consistant en aux rayons X, et constitués de couches d'un métal lourd tel que le tantale, le titane ou l'or déposé par voie electrolytique. Ces couches pourront avoir une épaisseur voisine de 0,1 mm.
Le positionnement des divers éléments constitutifs donne à l'objet de l'invention un maximum d'effets utiles qui n'avaient pas été, à ce jour, obtenus par des dispositifs similaires.

Claims

REVENDICATIONS
1°. Gaine filtre extensible à usage chirurgical pour veine cave ou gros vaisseaux sanguins, destinée à filtrer ou à diminuer le flot sanguin des veines et artères importantes et en particulier de la veine cave, dans le but de limiter les troubles circulatoires causés par une pression sanguine trop élevée, ou les risques d'infarctus provoqués par l'oblitération d'un vaisseau du myocarde par un caillot ou un corps étranger véhiculé par le sang circulant dans ladite gaine (2) étant auto-extensible, ou du type destinée à être mise en place au moyen d'un ballonnet gonflable (3) monté sur un cathéter, et constituée d'une portion de tube cylindrique pouvant s'étendre radialement et garder la forme ainsi obtenue, caractérisée en ce qu'elle est formée de deux éléments (5, 6) de longueurs différentes présentant une paroi à structure en treillis expansible radialement reliés entre eux par des barres ( 8 ) périphériques longitudinales disposées de manière à s'écarter en cône en travers du vaisseau sanguin pour former une grille de filtration, lorsque le plus long de ces deux éléments, l'élément de maintien (5), subit une expansion radiale, l'élément court (6) ne subissant pas d'expansion.
2°. Gaine selon la revendication 1, se caractérisant par le fait qu'elle est réalisée en matériau semi-rigide malléable, l'élément court (6) étant configuré pour permettre d'y insérer un ballonnet gonflable (3') monté à l'extrémité d'un cathéter (4) pour provoquer son expansion afin de supprimer la filtration en libérant entièrement le passage dans le vaisseau traité. 3°. Gaine selon la revendication 2, se caractérisant par le fait qu'elle est fabriquée sous forme expansée, puis "écrasée" sur le ballonnet gonflable (3).
4°. Gaine selon la revendication 1, se caractérisant par le fait qu'elle est auto-extensible et réalisée sous forme expansée dans un matériau flexible ou à mémoire de forme de manière à pouvoir effectuer sa mise en place en la comprimant radialement et en l'introduisant dans un tube creux de faible diamètre monté à l'extrémité d'un cathéter, puis en la chassant hors dudit tube lorsqu'elle se trouve à l'emplacement choisi, l'expansion de l'élément court (6) étant empêchée temporairement grâce à un ou plusieurs fils résorbables à longue durée de résorption, de façon à ce qu'il reprenne sa forme initiale au bout d'un temps plus ou moins long dépendant du nombre de fils, sans aucune intervention.
5°. Gaine selon l'une quelconque des revendications précédentes, se caractérisant par le fait que l'élément de maintien (5) est dimensionné pour assurer simultanément un accrochage du dispositif à l'emplacement choisi à l'intérieur du vaisseau interdisant toute migration, ainsi que la dilatation dudit vaisseau.
6°. Gaine selon l'une quelconque des revendications précédentes, se caractérisant par le fait qu'elle est d'une seule pièce et réalisée par électroérosion à partir d'un bloc de métal tel que l'acier inoxydable . 7°. Gaine selon l'une quelconque des revendications précédentes, se caractérisant par le fait qu'elle est constituée d'un élément de maintien (5) central relié par deux jeux de barres (8) de filtration à deux éléments courts expansibles terminaux (6, 6').
8°. Gaine selon l'une quelconque des revendications précédentes, se caractérisant par le fait que les barres (8) filtrantes ont une largeur voisine de 20/10 de millimètre, la largeur des éléments allongés (9) formant le treillis étant de l'ordre de 13/10 de millimètre.
9e. Gaine selon l'une quelconque des revendications précédentes, se caractérisant par le fait que les extrémités libres du ou des éléments courts (6, 6 ' ) expansibles radialement sont coupés en biais de manière à faciliter les déplacements de la gaine (2) lors de sa mise en place.
10°. Gaine selon l'une quelconque des revendications précédentes, se caractérisant par le fait qu'elle comporte des moyens d'accrochage intégrés, dirigés radialements vers l'extérieur de façon à s'enfoncer dans la paroi interne du vaisseau sous l'effet de la pression du ballonnet gonflable (3), empêchant ainsi toutes possibilités de déplacement du dispositif.
11°. Gaine selon l'une quelconque des revendications précédentes, se caractérisant par le fait que l'élément de maintien (5) est recouvert d'un film souple en matériau synthétique de manière à éviter que 1 'endothélium des vaisseaux de pénétrer à l'intérieur à travers les mailles du treillis. 12°. Gaine selon l'une quelconque des revendications précédentes, se caractérisant par le fait qu'elle comporte des repères radio-opaques consistant en points ou bandes longitudinales ou annulaires visibles aux rayons X, et constitués de couches d'un métal lourd tel que le tantale, le titane ou l'or déposé par voie electrolytique, ces couches ayant une épaisseur voisine de 0,1 m .
13°. Gaine extensible à usage chirurgical pou vaisseaux sanguins, destinée à servir d'élément d'ancrage d'une prothèse vasculaire tubulaire dans le cas d' anévrisme au voisinage de dérivations veineuses ou artérielles, et tout particulièrement pour un anévrisme de l'aorte abdominale situé près des départs des artères rénales, ladite gaine (2) étant auto-extensible, ou du type destinée à être mise en place au moyen d'un ballonnet gonflable (3) monté sur un cathéter, et constituée d'une portion de tube cylindrique pouvant s'étendre radialement et garder la forme ainsi obtenue, caractérisée en ce qu'elle est formée de deux éléments (5, 6) de longueurs différentes présentant une paroi à structure en treillis expansible radialement, reliés entre eux par des barres (8) périphériques longitudinales permettant un passage facile du sang vers des dérivations artérielles ou provenant de dérivations veineuses, le plus long de ces deux éléments, l'élément de maintien (5), étant destiné à être appliqué contre les parois d'une partie saine du vaisseau pour assurer l'accrochage, l'élément court (6) étant orienté vers 1' anévrisme et servant de support à ladite prothèse vasculaire .
14°. Gaine extensible selon la revendication 13, se caractérisant par le fait que l'élément court (6) comporte des éléments de fixation permettant la jonction de la gaine (2) et de la prothèse vasculaire.
15°. Gaine extensible selon la revendication 13, se caractérisant par le fait que la jonction de la gaine (2) et de la prothèse vasculaire est effectuée au moyen d'une pièce annulaire cylindrique interne ou externe
16°. Gaine extensible selon la revendication 13, se caractérisant par le fait que la jonction de la gaine (2) et de la prothèse vasculaire est effectuée au moyen de crochets ..
PCT/FR1996/001089 1996-07-12 1996-07-12 Gaine filtre extensible a usage chirurgical pour veine cave ou gros vaisseaux sanguins WO1998002112A1 (fr)

Priority Applications (2)

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AU66173/96A AU6617396A (en) 1996-07-12 1996-07-12 Extensible filtering sheath for surgical use for vena cava or large blood vessels
PCT/FR1996/001089 WO1998002112A1 (fr) 1996-07-12 1996-07-12 Gaine filtre extensible a usage chirurgical pour veine cave ou gros vaisseaux sanguins

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PCT/FR1996/001089 WO1998002112A1 (fr) 1996-07-12 1996-07-12 Gaine filtre extensible a usage chirurgical pour veine cave ou gros vaisseaux sanguins

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JP2013515575A (ja) * 2009-12-23 2013-05-09 パビリオン・メディカル・イノベーションズ・リミテッド・ライアビリティ・カンパニー 可逆的血管フィルターデバイスおよびその使用法
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