WO1996041590A1 - Endo-luminal implant - Google Patents

Endo-luminal implant Download PDF

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Publication number
WO1996041590A1
WO1996041590A1 PCT/IB1996/000566 IB9600566W WO9641590A1 WO 1996041590 A1 WO1996041590 A1 WO 1996041590A1 IB 9600566 W IB9600566 W IB 9600566W WO 9641590 A1 WO9641590 A1 WO 9641590A1
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WO
WIPO (PCT)
Prior art keywords
implant
ring
rings
longitudinal
characterized
Prior art date
Application number
PCT/IB1996/000566
Other languages
French (fr)
Inventor
Jean-Claude Sgro
Original Assignee
Cogent
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
Priority to FR95/07108 priority Critical
Priority to FR9507108A priority patent/FR2735016B1/en
Application filed by Cogent filed Critical Cogent
Publication of WO1996041590A1 publication Critical patent/WO1996041590A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure

Abstract

The invention concerns an endo-luminal implant comprising a plurality of mutually independent support rings (11 to 14) which have a common axis and are each integral with a flexible structural peripheral side member (6) which extends at least in the longitudinal direction of the implant, from one end thereof to the other. The rings and the side member are produced from a single filament (1) which is shaped in three dimensions along a substantially closed continuous line which defines in space a substantially tubular enveloping surface, and an alternating line on either side of a circumferential median line (4) centred on said axis, defining at least three loops (a to f) in the tubular surface determined by the series of enveloping surfaces of the respective support rings (4).

Description

ENDO-LUMINAL IMPLANT The present invention relates to an endo-luminal implant, substantially tubular general shape, can be introduced and implemented surgically in any anatomical conduit in humans or animals, in order to maintain or restore a passage in said conduit.

Such implants are well known in the medical and surgical art under the English term "stent" and are, in particular, used or used to treat humans arteries, including the coronary artery, to following angioplasty endoluminal for example.

The present invention relates more particularly to implants having a low "shape memory", or plasticity, for example due to the constituent material, in particular metal, chosen for its production or manufacture. From a relatively gathered initial conformation centripetally, favoring its introduction and its movement in the treated anatomical conduit, such an implant may take, once set up and positioned within said anatomical conduit, an expanded or deployed conformation so centrifugal, final, relatively radially resilient, so as to support and spread, and in a way, support the wall or the anatomical duct Treaty. The portion of the gathered-up configuration to the expanded conformation is obtained under the effect of a radial thrust applied to the interior of said implant, both along its entire length and over its entire circumference.

Such implants are used in general to the active distal end of a catheter or endoscope, provided with an inflatable or expandable balloon around which the implant is placed and held in its compact conformation. This endoscope is introduced into the anatomical conduit to be treated, for example the artery until it reaches the area to open or keep open. At this point, the balloon is inflated to expand or distend the implant in its final deployed configuration and is then deflated and extracted from the treated anatomical conduit, leaving in place the implant in its final position and expanded conformation, that is i.e. without returning to the gathered-up configuration of said implant.

According to US-A-4135536 there is disclosed an expandable stent balloon, consists of a single filiform element, the latter being formed into a series of rings of independent strut from each other, but integral each of at least one structuring spar, peripheral and flexible, extending at least along the longitudinal direction of the implant, from one end to the other thereof, in the tubular surface area determined by the following succession or envelope surfaces of various strut rings respectively. The rings are connected to each other longitudinally by welding, at two vertices loops of two adjacent rings so as to form the spar. The loops formed by the filiform element are not equal, an either side of a median line, which requires a prefolding of the single complex wire, in order to weld the tops of the loops in alignment. This way of folding and connecting the tops of the various rings provides a frangible connection, because the welds are subject to longitudinal mechanical stresses essentially in tension, when the prosthesis is expanded.

The present invention is proposed to solve the problems of the prior art by providing an implant similar to that defined in the previous document, but easier to manufacture and which has also, due to its particular structure, a large resistance to longitudinal mechanical stresses exerted by the expansion of the prosthesis.

According to the present invention, there is provided an endo-luminal implant for implantation in an anatomical conduit of the human or animal, in order to maintain or restore a passageway in said duct, obtained in the material relatively low memory, comprising:

- a plurality of rings strut, distributed along a longitudinal direction, having a common axis, independent of each other, but each secured to a peripheral structural spar, flexible, extending at least along the longitudinal direction of the implant, from one end to the other thereof, the rings and the longitudinal member being formed from a single threadlike element, in particular wire, obtained from said constituent material, running from one end to the the other of said implant;

- the filiform element being shaped in three dimensions to a continuous line substantially closed defining a space in the substantially cylindrical envelope surface, and said envelope surface an alternating line on either side of a line circumferential center centered on said axis, and defining at least three loops whose rounded peaks are alternately disposed on one side and the other side of said center line, into the tubular surface area determined by the succession of said lateral surfaces of said rings respectively. The implant is more particularly characterized in that the filiform element is further configured to present three successive rings;

- a longitudinal strand binding belonging both to a reference branch of a ring of a said reference loop, and a branch of a loop of the next ring said ring, and a second longitudinal curve connecting belonging to both said reference branch of said reference loop of said ring, and a branch of a loop of the ring preceding said ring; - and an extreme longitudinal curve of the same threadlike element belonging to a branch of a loop of an end ring and the other extreme longitudinal curve of the same threadlike element belonging to a branch of a loop of the other end ring; - the longitudinal strands being gathered together and fastened in pairs at each strut ring to form together said flexible spar.

With the implant endolumnial according to the invention, it is, moreover, possible to expand or dilate in a differentiated and independent manner, the various strut rings respectively, thus to better adapt to the configuration of the conduit anatomical Treaty, the light may have a variable or irregular cross-section along its length. Thanks to the invention also in case of substantial expansion or distension of a strut ring, the flexible device may take spar locally, that is to say at the distended ring, an oblique conformation, involved in the expansion of said ring, and absorbent, as it were, its excessive distension. In this manner linkages interconnecting the two strands in each ring working in shear in the direction of longitudinal traction and essentially along the axis of the implant, and not perpendicularly thereto. This particular structure allows to limit the risk of weakening and breaking of bonds in the form, for example, welds, unlike the known prior art implants.

The present invention is now described with reference to the accompanying drawing, wherein: FIG 1 shows, in its final expanded configuration, an implant according to a first embodiment of the invention; 2 shows the implant of Figure 1 in its compact initial conformation;

FIG 3 is a partial elevational view of the implant shown in Figure 1, at a ring • strut; FIG 4 is a view in section along the line IV-IV of Figure 3 of the ring strut shown in Figure 3; FIG 5 is an elevational view of the ring shown in FIG 3, according to another viewing angle; FIG 6 is an elevational view, in its final expanded conformation of an implant according to the embodiment of Figure 1 of the invention; FIG 7 is an elevational view, in its final expanded conformation of an implant according to a second embodiment of the invention; FIG 8 is a schematic view of the prefolding of a single wire constituting the implant according to the invention during the manufacture thereof; FIG 9 is a front view of a strut ring of an implant according to a third embodiment of the invention;

FIG 10 is a front view, according to another viewing angle of the ring strut shown in Figure 9,

FIGS 11 and 12 are sectional views, respectively along the XV-XV and XVI-XVI line of FIG 8, the ring strut shown in Figure 8.

According to Figures 1 to 6, an endo-luminal implant according to the invention is obtained or made of a constituent material having finally, that is to say, after completion of the implant and optionally subsequent heat treatment thereof, a low memory, or a certain plasticity or malleability, while retaining sufficient rigidity to prevent any return of the expanded shape of the implant to its original shape picked up. Such constituent material may be a metal or a metal alloy with these characteristics, for example stainless steel, titanium, tantalum, gold, platinum, etc., or any other biocompatible material, in particular material plastic, having the required mechanical characteristics. As shown in Figures 1 and 2, and given the intrinsic mechanical properties of the constituent material of the implant according to the invention, the latter is capable of assuming an initial configuration gathered up, of relatively small cross section, shown in Figure 2, and an expanded conformation, ultimately, of relatively large cross section, relatively resistant vis-à-vis all radial force, shown in Figure 1. the portion of initial configuration gathered up in the final expanded configuration, is obtained, as already indicated, under the effect of a radial thrust applied to the interior of the implant, both along its entire length and over its entire circumference.

Generally, the implant structure 1 according to the invention comprises: a plurality of rings of strut 11 to 14, each determining a surface of tubular or cylindrical envelope, distributed in the longitudinal direction of the implant, independent of each other, in the sense that lesάits rings are not directly connected or integral with each other, and remote or spaced apart from each other; -a spar 6 structurant, peripheral or lateral, flexible, extending at least along the longitudinal direction of the implant, from one end to the other thereof, in the tubular surface area determined by the succession of surfaces envelope of the rings 11-14 respectively forestay; each ring 11-14 is secured to the side member 6, approximately according a generatrix of the surface of said envelope, tubular or cylindrical shape. Each ring strut 11 to 14, so that the beam is obtained from a single threadlike element 1 obtained in the above-mentioned constituent material, composed by forming four sections 21-24 interconnected by the single and even filiform element, and respectively defining the strut rings 11-14.

As shown more particularly in Figures 3 to 5, each ring strut, for example 12, is constituted by the corresponding section 22 of the wire element 1, shaped in three dimensions, according to a continuous line substantially closed defining in space a substantially cylindrical or tubular envelope surface. In this envelope surface, the section 22 of the elongated member defines a line of alternating either side of a center line 4, circumferential, centered on the axis 3 common to all the rings strut 11 14 in the expanded or gathered-up configuration of the implant. Also in the surface of cylindrical casing section 22 of the wire element 1 defines six loop a to f, each having the form of a pin parallel branches to each other and to the axis 3, in the expanded conformation of Figure 1. the rounded corners of the loops a-f are arranged alternately on one side and the other of the center line 4. "filiform element" is any element having generally the form of a wire, obtained from the above-mentioned constituent material, consisting of son or filaments themselves, linked to each other by any suitable means, such as twisting or braiding for example. As shown more particularly in Figure 1, the strut rings 11 to 14 are distributed along the longitudinal direction of the implant, being angularly oriented with respect to the axis 3 of the implant, and with respect to each other, ensure that the rounded corners of a ring, for example 12, situated on the same side thereof, adjacent to the recesses of the next ring, for example 13, located on the side adjacent said one side; in a way, depending on the length of the implant, the loops are arranged with respect to each other, "head to tail". And the strut rings 11 to 14 are angularly offset from each other, about the axis 3, so that the vertices in correspondence with the six loop a to f, the various rings 11-14 respectively to determine least three lines, for example six lines helically included in the tubular surface of the implant, as determined as previously stated by the succession of envelope surfaces of the different rings 11-14 strut.

It follows from the foregoing description that each ring strut 11-14 has a largely perforated outer surface, in particular limiting the minimum necessary contact between the implant and the wall of the anatomical conduit.

According to the first embodiment of the invention, the side member 6 and the various rings 11-14 strut are formed from the single filiform element, running from one end to the other of the implant, through sections 21-24 described above, shaped to constitute four successive rings 11-14 respectively. The beam 6 is obtained by forming the above-mentioned thread-like element, by bringing together in a single line disposed in the tubular casing of the implant, different longitudinal strands formed at the various rings respectively, and by joining the to constitute together the aforementioned spar. Referring to strut rings 11 to 13, the beam 6 is obtained as follows: -a longitudinal curve the link belongs to both a reference branch dl a reference loop of ring 12, and a corresponding branch dl of a corresponding loop of the next ring 13; -a second strand lb longitudinal connecting belongs to both the reference branch dl of the reference loop of the ring 12, and a corresponding branch dl of a corresponding loop of the previous ring 11; -a longitudinal curve the end of the filiform element 1 belongs to or is connected to a branch dl a loop of the end ring 11, while the other extreme longitudinal strand ld the same threadlike element 1 belongs or is integral of dl branch a loop of the other end ring 14; -As shown in Figure l, the longitudinal strands are gathered close together or in pairs, in each ring 11 to 14, to form and define together the flexible beam 6.

As shown in Figure 1, the side member 6 has a profile describing in the tubular surface of the implant, a slightly inclined propeller relative to the axis 3 of implant.

As shown in Figure 2, the initial conformation obtained is collected by forcing into contact with each other, the ends of the two branches of different loops a-f of the different rings 11 to 14. In respect of the yield strength of the material, the initial conformation may be even more compact, crossing the same branches of the aforementioned loops.

And, in accordance with Figure 1, the expanded conformation is obtained by removing those branches of the same loop a to f, so as to bring them into a position parallel to each other and to axis 3, to the manner of a "U".

Figure 6 more clearly illustrates the embodiment according to Figs 1-5, showing that the longitudinal strands to ld are joined in pairs, for example by welding, so as to obtain the beam 6.

Accordance with the second embodiment according to Figure 7, these longitudinal strands to the ld are joined in pairs by links 8, again so as to obtain the beam 6.

Figure 8 shows schematically how the implant is manufactured. This implant is easier to manufacture than those known from the prior art, in that it consists of a single filiform element bent lines or loops alternating equal and simple steps. The implant can thus be manufactured simply by helically winding the wire member about a mandrel, for example, by bringing together the longitudinal strands to ld and the solidarisant in pairs at each ring 11-14 of strut to form together said flexible spar 6.

The third embodiment of the invention described with reference to Figures 9 to 12, differs from the first embodiment, in that each ring strut 11 to 14, for example 12, comprises eight loops, determined by the corresponding section, for example 22, of the filiform element.

Manner not shown, the thread-like element 1 may be coated with a biologically compatible material, protecting the one hand, and the insulation of the wall of the anatomical conduit, on the other hand. A protective sleeve, always compatible material may cover the entire implant, for example for insertion into the anatomical canal.

Claims

1 / endo-luminal implant, intended to be implanted in an anatomical conduit of the human or animal, in order to maintain or restore a passageway in said duct, obtained in a material constituting at relatively low memory, comprising :
- a plurality of rings strut (11 to 14) distributed along a longitudinal direction, having a common axis, independent of each other, but each secured to a beam (6) structuring device, flexible, extending at least in the longitudinal direction of the implant, from one end to the other thereof, the rings (11 to 14) and the longitudinal member being formed from a single element (1) filiform including wire, obtained from said constituent material, running from one end to the other of said implant;
- the filiform element being shaped in three dimensions to a continuous line substantially closed defining a space in the substantially cylindrical envelope surface, and said envelope surface an alternating line on either side of a line circumferential center (4) centered on said axis, and defining at least three loops (a to f) whose rounded peaks are arranged alternately on one side and the other side of said center line (4) in the tubular surface determined by the succession of said lateral surfaces of said rings respectively, characterized in that flood the filiform element (1) is further configured to present three successive rings (11 to 14);
- a blade (la) longitudinal connecting belonging to both a reference branch (dl) of a reference loop (d) a said ring (12) and a leg (dl) of a loop ( d) the following ring (13) said ring (12) and a second strand (Ib) longitudinal link belonging to both said leg (dl) of reference of said reference loop (d) of said ring (12 ) and a branch (dl) of a loop (d) of the preceding ring (11) said ring (12); - and an extreme longitudinal strand (the) of the filiform element belonging to one class (dl) of a loop (d) an end ring (21) and the other extreme longitudinal strand (ld) of the (dl ) filiform element belonging to one class (dl) of a loop (d) of the other ring (14) end; - the longitudinal strands (in the ld) being assembled and fixed in pairs at each ring (11 to 14) strut to form together said flexible spar (6).
2 / An implant according to claim 1, characterized in that the strands (the ld) are joined in pairs by welding (7) or links (8) the solidarisant.
3 / An implant according to Claim 1, characterized in that the longitudinal carrier (6) has a profile describing in the tubular surface of the implant a slightly inclined propeller relative to the axis (3) of said implant.
4 / implant according to claim 1, characterized in that the filiform element section (21 to 24) of each ring (there 14) strut described in its lateral surface an alternating line linking six loops (a to f), the rounded corners are arranged alternately on one side and the other of the center line (4) of said alternate line. 5 / implant according to claim 1, characterized in that the rings (11 to 14) are distributed along the longitudinal direction of the implant, being angularly oriented with respect to the axis (3) of said implant, and with respect to each other, so that the rounded corners of a ring (12), situated on the same side thereof, adjacent to the ring recess (13) delivery, located on the side adjacent to said same side.
6 / An implant according to claim 5, characterized in that the rings (11 to 14) are angularly offset relative to each other about said axis (3), so that the peaks corresponding loops (a to f) different rings respectively determine at least three lines helically in the outer surface of the implant. 7 / An implant according to claim 1, capable of assuming an initial configuration gathered up (Fig. 2), wherein the two arms of the different loops (a to f) are at their respective ends in contact with each other, and under the effect of a radial thrust applied to the interior of said implant along its entire length and circumference, an expanded conformation (Fig. 1) wherein these branches are spaced apart from each other, characterized in that in said deployed configuration, the legs of the loops (a to f) of the implant are each parallel to the axis (3) thereof.
8 / An implant according to claim 1, characterized in that it is covered by a protective sleeve, or coated with a biocompatible material.
PCT/IB1996/000566 1995-06-09 1996-06-07 Endo-luminal implant WO1996041590A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
FR95/07108 1995-06-09
FR9507108A FR2735016B1 (en) 1995-06-09 1995-06-09 endo-luminal implant

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
AU57764/96A AU5776496A (en) 1995-06-09 1996-06-07 Endo-luminal implant

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FR (1) FR2735016B1 (en)
WO (1) WO1996041590A1 (en)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5800515A (en) * 1995-08-03 1998-09-01 B. Braun Celsa (Societe Anonyme) Prosthesis implantable in a human or animal duct such as a stent or a prosthesis for aneurism
US6066169A (en) * 1998-06-02 2000-05-23 Ave Connaught Expandable stent having articulated connecting rods
US6071308A (en) * 1997-10-01 2000-06-06 Boston Scientific Corporation Flexible metal wire stent
US6730117B1 (en) * 1998-03-05 2004-05-04 Scimed Life Systems, Inc. Intraluminal stent

Families Citing this family (1)

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Publication number Priority date Publication date Assignee Title
IL143048D0 (en) * 1998-11-09 2002-04-21 Mivi Technologies Inc Expandable stent and method for manufacturing same

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US4856516A (en) * 1989-01-09 1989-08-15 Cordis Corporation Endovascular stent apparatus and method
US4994071A (en) * 1989-05-22 1991-02-19 Cordis Corporation Bifurcating stent apparatus and method
WO1992009246A1 (en) * 1990-11-28 1992-06-11 Numed, Inc. Intravascular radially expandable stent and method
US5133732A (en) * 1987-10-19 1992-07-28 Medtronic, Inc. Intravascular stent
US5135536A (en) * 1991-02-05 1992-08-04 Cordis Corporation Endovascular stent and method
EP0540290A2 (en) * 1991-10-28 1993-05-05 Advanced Cardiovascular Systems, Inc. Expandable stents and method for making same
EP0556850A1 (en) * 1992-02-21 1993-08-25 Mintec Inc Intraluminal stent
DE4303181A1 (en) * 1993-02-04 1994-08-11 Angiomed Ag An implantable catheter
EP0669114A1 (en) * 1994-02-25 1995-08-30 Robert E. Fischell Stent having a multiplicity of closed circular structures

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Publication number Priority date Publication date Assignee Title
US5133732A (en) * 1987-10-19 1992-07-28 Medtronic, Inc. Intravascular stent
US4856516A (en) * 1989-01-09 1989-08-15 Cordis Corporation Endovascular stent apparatus and method
US4994071A (en) * 1989-05-22 1991-02-19 Cordis Corporation Bifurcating stent apparatus and method
WO1992009246A1 (en) * 1990-11-28 1992-06-11 Numed, Inc. Intravascular radially expandable stent and method
US5135536A (en) * 1991-02-05 1992-08-04 Cordis Corporation Endovascular stent and method
EP0540290A2 (en) * 1991-10-28 1993-05-05 Advanced Cardiovascular Systems, Inc. Expandable stents and method for making same
EP0556850A1 (en) * 1992-02-21 1993-08-25 Mintec Inc Intraluminal stent
DE4303181A1 (en) * 1993-02-04 1994-08-11 Angiomed Ag An implantable catheter
EP0669114A1 (en) * 1994-02-25 1995-08-30 Robert E. Fischell Stent having a multiplicity of closed circular structures

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5800515A (en) * 1995-08-03 1998-09-01 B. Braun Celsa (Societe Anonyme) Prosthesis implantable in a human or animal duct such as a stent or a prosthesis for aneurism
US6071308A (en) * 1997-10-01 2000-06-06 Boston Scientific Corporation Flexible metal wire stent
US6723118B1 (en) 1997-10-01 2004-04-20 Scimed Life Systems, Inc. Flexible metal wire stent
US6976994B2 (en) 1997-10-01 2005-12-20 Boston Scientific Scimed, Inc. Flexible metal wire stent
US8764815B2 (en) 1998-03-05 2014-07-01 Boston Scientific Scimed, Inc. Intraluminal stent
US6730117B1 (en) * 1998-03-05 2004-05-04 Scimed Life Systems, Inc. Intraluminal stent
US8118858B2 (en) 1998-03-05 2012-02-21 Boston Scientific Scimed, Inc. Intraluminal stent
US6066169A (en) * 1998-06-02 2000-05-23 Ave Connaught Expandable stent having articulated connecting rods

Also Published As

Publication number Publication date
FR2735016B1 (en) 1997-12-12
FR2735016A1 (en) 1996-12-13
AU5776496A (en) 1997-01-09

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