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Patent Searching and Data


Title:
ENDOVASCULAR DEVICE FOR DYSFUNCTIONAL FISTULAS
Document Type and Number:
WIPO Patent Application WO/2020/152600
Kind Code:
A4
Abstract:
The endovascular device (1 ) according to the invention comprises a first tubular sheath in turn comprising a fibrous layer (5) made of a fibrous material containing a coherent assembly of fibers. The ends of the device (1) form two expansion sections (7A, 7B) each of which in turn comprises an expander device (70) arranged to radially expand the endovascular device (1) at least in correspondence with the respective expansion section (7A,7B). The fibrous layer (5), in particular in correspondence with the intermediate section (11 ) is, on the other hand, prickable and capable of quickly closing and resealing the holes produced by the needles for dialysis, transfusions or injections. This feature allows (20) compared to current devices, to treat malfunctioning dialysis fistulas and to avoid the exclusion of a part of the superficial venous circuit potentially usable for the hemodialysis session, so that the device being a maintenance device for fistulas from dialysis.

Inventors:
SALSANO ANTONIO (IT)
SALSANO GIANCARLO (IT)
Application Number:
PCT/IB2020/050496
Publication Date:
October 29, 2020
Filing Date:
January 22, 2020
Export Citation:
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Assignee:
SALSANO ANTONIO (IT)
SALSANO GIANCARLO (IT)
International Classes:
A61F2/07; A61F2/06; A61M1/36
Attorney, Agent or Firm:
STERAF SRL et al. (IT)
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Claims:
1

AMENDED CLAIMS

received by the International Bureau on August 22, 2020

1 ) Endovascular device (1 ) for dysfunctional dialysis surgical fistulas comprising a first tubular sheath comprising a fibrous layer (5) made of a fibrous material containing a coherent set of fibers, that said endovascular device comprises at least two expansion sections (7A, 7B) wherein each of them comprises an expander device (70) arranged to radially expand the endovascular device (1 ) at least in correspondence with the respective expansion sections (7A, 7B), characterized in that said device (1 ) forms two ends and comprises an intermediate section (1 1 ) which extends between the two ends of the device (1 ) itself and is devoid of expanded devices (70) and others metal bodies or bodies, so that this intermediate section (11 ) closes or in any case tends to close the holes produced several times by a needle for example for haemodialysis treatments, and the fibrous layer (5), in particular in correspondence with the intermediate section (1 1 ), is prickable and able to close and reseal quickly and with an optimized held the holes produced by the needles, said fibrous layer (5) extends at least in correspondence with said intermediate section (1 1 ), said fibrous layer (5) becoming endothelized, said device (1 ) being a device for the treatment of dysfunctional surgical fistulas, adapted to be inserted inside the surgical fistula, when it begins to shrink or occlude after a certain number of punctures, to keep it pervious, increasing the survival of the dialysis fistulas.

2) Endovascular device (1 ) according to claim 1 , wherein the endovascular device (1 ) forms two ends and each expansion section (7A, 7B) is placed at or near a respective end of the endovascular device (1 ) itself.

3) Endovascular device (1 ) according to the preceding claims, wherein the fibrous layer (5) extends at least in correspondence with said intermediate section (1 1 ).

4) Endovascular device (1 ) according to the preceding claims, wherein the fibrous layer (5) extends substantially widely over the entire length of the endovascular device (1 ).

5) Endovascular device (1 ) according to the preceding claims, wherein at least part of the fibres of the fibrous layer (5) are obtained by electrospinning and the fibrous layer (5) comprises fibre based on one or more of the following materials: a polyurethane resin, a polymeric material which cannot be absorbed by the organism in which the endovascular device (1 ) is implanted. 2

6) Endovascular device (1 ) according to the preceding claims in which the fibrous layer (5) does not disappear with the passage of time avoiding the wear of the device which would present irregular thickness and resistance to punctures, and therefore would be prone to bleeding, to breakage as result of repeated punctures and restenosis; the device (1 ) therefore resulting more reliable and having a longer operating life.

7) Endovascular device (1 ) according to one or more preceding claims, wherein each expanding device (70) comprises one or more elements realized in a memory shape material, such as for example a metallic material.

8) Endovascular device (1 ) according to one or more preceding claims, wherein each expander device (70) comprises one or more elements made of a shape memory material, such as for example an environmentally absorbable polymeric material, for example based on poly (L-lactide) or poly (D, L-lactide), so that in the event a restenosis is formed inside the device (1 ), the fistula can be renewed by positioning a second device (1 ), for example inside the first, to cover the restenosis, avoid losing an area of the dialysis fistula that is prickable.

9) Endovascular device (1 ) according to one or more preceding claims, comprising a second (9) and / or a third tubular sheath (3), each of which is made of a material chosen from the following group: polytetrafluoroethylene, expanded polytetrafluoroethylene, a resin optionally expanded synthetic, one or more optionally expanded fluorinated polymers, one or more optionally expanded perfluorocarbons; and wherein the second tubular sheath (9) is disposed within the fibrous layer (5), and the third tubular sheath is disposed within the fibrous layer (5).

10) Method for realizing an endovascular device (1 ) having the characteristics according to one or more preceding claims, comprising the operation of realizing at least part of the fibres of the fibrous layer (5) by electrospinning.