WO2020099666A2 - Percutaneous vascular bypass method and device - Google Patents

Abstract

The invention relates to a method for a percutaneous bypass between an upstream arterial or venous zone and a downstream arterial or venous zone located respectively upstream and downstream of an obstructed part, or an injured part of an affected vessel of a human or animal patient. The invention also relates to stent sections particularly adapted to this method.

Description

 PERCUTANEOUS VASCULAR BRIDGING METHOD AND DEVICE

LINK TO A PREVIOUS APPLICATION

 The present application claims priority from application EP18206475, the content of which is fully included here by reference.

TECHNICAL FIELD OF THE INVENTION

 The invention relates to percutaneous bypass surgery.

STATEMENT OF THE INVENTION

 Percutaneous bypass surgery aims to reproduce as closely as possible the conditions of surgical bypass surgery, while avoiding the deleterious drawbacks of the surgical approach. It is intended to be reliable, reproducible, suitable for the majority of situations encountered in human or animal pathology.

According to a first aspect of the invention, it relates to a percutaneous bypass method between an upstream arterial zone and a downstream arterial zone located respectively upstream and downstream of an obstructed, permeable or injured part d an artery affected by a vascular network of a human or animal patient, the method comprising: placing a wired working guide in such a way that the wired working guide passes through a working orifice through a wall '' a blood vessel of the vascular network, crosses by an upstream arterial orifice an arterial wall of the upstream arterial zone, crosses by a downstream arterial orifice an arterial wall of the downstream arterial zone, travels in the vascular network between the working orifice and the upstream arterial opening, travels out of the vascular network between the upstream arterial opening and the downstream arterial opening and runs in the downstream arterial zone between the downstream arterial opening and a downstream end of the wire guide; then a release of a downstream endoprosthesis portion in the downstream arterial zone, followed by a release of an upstream endoprosthesis portion in the upstream arterial zone, the upstream endoprosthesis portion being connected without disjunction to the downstream endoprosthesis portion, the upstream endoprosthesis and downstream endoprosthesis portions having been introduced through the working orifice and having traveled along the working wire guide.

The upstream endoprosthesis portion is connected without disjunction to the downstream endoprosthesis portion, the upstream endoprosthesis and downstream endoprosthesis portions forming the bypass. Naturally, the procedure ends with an extraction of the working wire guide through the working port and a closing of the working port.

According to a preferred embodiment, the method comprises a percutaneous introduction of a tubular working introducer so that the tubular working introducer surrounds the wired working guide, and that the working introducer passes through through the working orifice the wall of the blood vessel of the vascular network, crosses through the upstream arterial orifice the arterial wall of the upstream arterial zone, crosses through the downstream arterial orifice the arterial wall of the downstream arterial zone, travels through the vascular network between the working orifice and the upstream arterial orifice, runs out of the vascular network between the upstream arterial orifice and the downstream arterial orifice and runs in the downstream arterial zone between the downstream arterial orifice and a downstream end of the work introducer.

In this case, the upstream endoprosthesis portion and the downstream endoprosthesis portion are positioned, before the release, in the work introducer, the release of the downstream endoprosthesis portion and the release of the portion upstream endoprosthesis following a progressive retraction of the downstream end of the working introducer.

The upstream endoprosthesis portion and the downstream endoprosthesis portion can be conveyed from the arterial orifice of entry into the working introducer after the percutaneous installation of the working introducer. Alternatively, the upstream endoprosthesis portion and the downstream endoprosthesis portion can be positioned in the working introducer before the percutaneous placement of the working introducer. According to one embodiment, the establishment of the wired working guide comprises a subcutaneous, above-facial, or anatomical tunneling of the wired working guide between the upstream arterial orifice and the downstream arterial orifice.

Several sequences can be envisaged for the establishment of the working wire guide. One can in particular provide for the introduction of the wired working guide into the downstream arterial zone through the downstream arterial orifice, then the introduction of the wired working guide through the upstream arterial orifice into the upstream arterial zone and its path to the work opening. Alternatively, provision may be made for transcutaneous placement of the working wire guide between the working orifice and the upstream arterial orifice and then the introduction of the working wire guide into the downstream arterial zone through the downstream arterial orifice. In this hypothesis, provision can be made for transcutaneous positioning of the working wire guide between the working opening and the upstream arterial opening by introducing the working wire guide either through the working opening or through the opening upstream arterial. The upstream stent portion and the downstream stent portion are intended to form a continuous bypass between the upstream arterial zone and the downstream arterial zone, with different possible embodiments.

According to a first embodiment, provision can be made for the upstream endoprosthesis portion to be connected without disjunction to the downstream endoprosthesis portion directly by an intermediate portion of endoprosthesis constituting a single endoprosthesis with the portion of upstream endoprosthesis and the downstream stent portion.

According to another embodiment, the upstream stent portion is connected without disjunction to the downstream stent portion by a tubular fitting between the upstream stent section and the downstream stent section. According to another embodiment, the upstream endoprosthesis portion is connected without disjunction to the downstream endoprosthesis portion by a tubular fitting between the upstream endoprosthesis section and an upstream end of a set of one or several intermediate stents and a tubular fitting between the downstream stent section and a downstream end of the assembly one or more intermediate stents, the intermediate stents being fitted into each other.

The fittings may be carried out between two superimposed end parts of two adjacent stent sections, the two end parts having a generally cylindrical tubular shape, at least one of the two end parts being provided with 'roughness, for example of hooks, pins or bosses, coming to anchor in or through the other end part.

To anchor the roughness of one of the two end parts in the other end part, it is possible to inflate a balloon which allows the two parts of the ends to overlap radially one against the other. 'other.

To avoid leaks or injuries at the level of the downstream artery orifice, provision may be made for the downstream endoprosthesis portion to include a terminolateral endoprosthesis portion, preferably having a flared end portion deploying around the downstream artery orifice inside a vessel of the downstream arterial zone, and a tubular lateral part crossing the downstream artery orifice.

To avoid leaks or injuries at the upstream arterial orifice, provision can be made for the upstream endoprosthesis portion to include a terminolateral endoprosthesis portion, preferably having a flared end portion deploying around the upstream arterial orifice inside a vessel of the upstream arterial zone, and a tubular lateral part crossing the upstream arterial orifice.

The position of the working orifice is chosen according to the position of the obstructed, permeable or injured part of the affected artery. According to one embodiment, the affected artery and the upstream and downstream arterial zones are located homolaterally downstream of a bifurcation of a common artery, also supplying a contralateral artery constituting the blood vessel. For example, the upstream arterial zone may be the homolateral superficial femoral artery, preferably 3 to 10 cm downstream of the femoral bifurcation, the downstream arterial zone being the high or low popliteal artery, the blood vessel preferably being the contralateral common femoral artery. The surgical procedure is also applicable when the upstream arterial zone is the common femoral artery and the downstream arterial zone is a more distal artery, or when the bypass is an interfemoral bypass, an aortofemoral bypass, or an iliofemoral bypass.

According to another aspect of the invention, it relates to a portion of end-to-side endoprosthesis, comprising a flared end portion capable of deploying inside a blood vessel, around a orifice formed in a wall of the blood vessel, being pressed against the wall of the blood vessel around the orifice, and a tubular lateral part capable of passing through the orifice. This stent portion is particularly suitable for the bypass procedure described above.

According to another aspect of the invention, it relates to a set of two sections of stent particularly suitable for the bypass procedure described above. The stent sections have two overlapping end parts to form a fitting, the two end parts having a generally tubular shape, at least one of the two end parts being provided with asperities, for example of hooks, pins or bosses, capable of being anchored in or through the other end part.

Asperities can project radially outward from an outer face of said one of the two end parts, so as to anchor in or through an inner radial face of the other part of end. Alternatively, they can project radially inwards from an inner face of said one of the two end parts, so as to anchor in or through an outer radial face of the other end part. Where appropriate, the other of the two end parts is also provided with asperities, for example hooks, pins or bosses, capable of being anchored in or through said one of the end parts.

According to another aspect of the invention, it also relates to a stent kit comprising a plurality of stent sections, including at least two end stent sections each comprising a terminal part flared capable of deploying inside a blood vessel, around an orifice formed in a wall of the blood vessel, by being pressed against the wall of the blood vessel around the orifice, and a tubular lateral part capable of pass through the orifice, and at least two intermediate stent sections of different lengths, the sections of the plurality of sections constituting two by two of the sets of two stent sections, having two end portions which can be stacked to form a fitting , the two end parts having a generally tubular shape, at least one of the two end parts being provided with asperities, for example hooks, pins or bosses, capable of being anchored in or at across the other end portion, so that any two of the stent sections of the plurality of stent sections can be end-to-end, to form a stent as required ntage of desired length comprising two, three or four, stent sections, or even more, the two end stent sections being located at the ends. BRIEF DESCRIPTION OF THE FIGURES

Other features and advantages of the invention will emerge on reading the description which follows, with reference to the appended figures, which illustrate: FIG. 1, puncture points for the implementation of the surgical procedure according to the invention, in the case of femoro-popliteal bypass - Figure 2, the path of a wire guide passing through orifices made at the puncture points of Figure 1; Figure 3, the resulting bypass at the end of the procedure; Figure 4, a section of terminolateral endoprosthesis particularly suitable for the procedures according to the invention; - Figure 5, a stent section particularly suitable for procedures according to the invention; Figure 6, the stent section of Figure 5, fitted into an adjacent stent section. For clarity, identical or similar elements are identified by identical reference signs in all of the figures.

DETAILED DESCRIPTION OF EMBODIMENTS

 FIG. 1 illustrates puncture points corresponding to the working orifice 10, to the upstream arterial orifice 12 and to the downstream arterial orifice 14 formed in the walls of arterial vessels, the upstream arterial orifice 12 and the downstream arterial orifice 14 being located respectively in an upstream arterial zone 16 and a downstream arterial zone 18, on either side of an obstructed part 20, permeable or injured by an artery affected by a vascular network of a human patient. In Figure 2 is illustrated the path of a wired working guide 22 so that the wired working guide enters the vascular network through the working orifice 10, travels in the vascular network between the orifice 10 and the upstream arterial orifice 12, crosses the upstream arterial orifice 12, travels out of the vascular network between the upstream arterial orifice 12 and the downstream arterial orifice 14, crosses the downstream arterial orifice 14 and travels in the downstream arterial zone 16 between the downstream arterial orifice 14 and a downstream end 24 of the wire guide 22.

The same path is followed by a tubular working introducer which slides on the wire guide and makes it possible to route and release a bypass endoprosthesis 24, visible in FIG. 3. The bypass endoprosthesis 25 can be in one piece or in several pieces, and comprises at least one portion of upstream endoprosthesis 26 in the upstream arterial zone 16, a portion of downstream endoprosthesis 28 in the downstream arterial zone 18, the portion of upstream stent being connected without disjunction to the downstream endoprosthesis portion, and, where appropriate, an intermediate endoprosthesis portion 30, in one or more pieces.

The end-to-end endoprosthesis portion 32 illustrated in FIG. 4, intended to form an upstream endoprosthesis portion 26 or a downstream endoprosthesis portion 28, comprises a flared end portion 34 able to deploy inside d 'a blood vessel, around an orifice 12, 14 formed in a wall of the blood vessel, being pressed against the internal wall of the blood vessel around the orifice in a sealed manner, and a tubular lateral part 36 able to pass through the orifice 12, 14. The stent section is preferably made of material to shape memory, for example made of Nitinol covered if necessary with a protective layer, for example made of PTFE.

The stent section 38 shown schematically alone in Figure 5 and fitted into a second stent section 40 in Figure 6, has a tubular end portion 42 intended to be fitted into a portion of corresponding end 44 of the second section 40. This end part 42 is provided with asperities 46, for example hooks, pins or bosses, capable of being anchored in or through the other end part 44. More specifically, the protrusions 46 project radially outward from an outer face of the end portion 42, at a distance preferably of a few millimeters from the end of the stent section 40, and are intended to anchor in or through an inner radial face of the other end part 44. To anchor the asperities 42, a balloon is inflated which allows the two end parts 42, 44 to be pressed radially one against the other.

This method of attachment between endoprosthesis sections can be adapted to the end-to-side endoprosthesis of FIG. 4, by providing asperities on the outer face of an end part of the tubular lateral part 36.

Alternatively, provision can be made for the protrusions to project radially inward from an inner face of said one of the two end parts, so as to anchor in or through an outer radial face of the 'other end part.

The standard procedure for femoro-popliteal bypass surgery can include the following steps:

Joint contralateral retrograde femoral puncture, aortic cross over and placement of a tubular introducer of sufficient diameter and length (usually diameter 7 or 8F, length 90cm). Retrograde puncture of the homolateral superficial femoral artery, at a sufficient distance downstream of the femoral bifurcation (approximately 4 to 5cm), helped by ultrasound or radio guidance, and that whether the artery is permeable or occluded. Rise of a wire guide then of a short tubular introducer and of diameter equivalent or close to the first, until in the common femoral artery homolateral.

Recovery of a long wire guide entering through an introducer and coming out through the other.

Pushing the long tubular introducer in place of the short introducer, allowing externalization of the end of the long introducer at the level of the upper thigh.

Anterograde ultrasound-guided puncture of the downstream artery (in general, high or low popliteal artery), placement of a short introducer of diameter equivalent or close to the previous ones, anterograde, then of a wire guide descending into the arterial network of 'downstream. The introducer can advantageously be replaced by a peelable introducer.

Tunneling of the long wire guide, subcutaneous, supra or sub facial, or anatomical. Introduction of the long wire guide successively passing through the three introducers.

Thrust from the long introducer, along the wire guide, into the recipient artery downstream of its reentry zone

Release of a flexible covered stent anchoring over a sufficient distance, for example 4 cm into the arterial lumen, with concomitant retraction of the introducer. Several stents can be used to perform the entire bypass with enough overlap between them to avoid any disjunction, for example 4 cm. On the proximal part, the endoprosthesis is released into the superficial femoral artery over a sufficient distance to allow its support (for example 4 cm), without obstructing the deep femoral artery (flush with the ostium of the superficial femoral artery)

Balloon expansion of the entire stent then angiographic control. - Ablation of the long introducer and closure of the contralateral femoral joint by arterial closure system or compression.

The puncture orifices at the homolateral limb do not need to be closed or compressed, the endoprosthesis ensuring sealing at the exit and reentry holes in the artery. The different times can be performed in a different order.

Different variants are possible, and in particular:

First puncture performed at the homolateral, anterograde iliac or femoral artery

Use of a lateral needle catheter allowing the perforation of the artery from inside to outside. This process can be used for upstream as for downstream, or for both, possibly avoiding the puncture (s) from outside to inside.

Venous bypass: retrograde puncture of the superficial femoral artery 4 cm below its ostium, retrograde and placement of an introducer. Anterograde puncture (at best ultrasound guided) of the long saphenous vein and placement of an introducer. Puncture (ultrasound-guided) of the distal long saphenous vein (or stripping), placement of an introducer, then of a long guide. The guide is collected by the introducer of the upper portion, then tunneled subcutaneously, and reintroduced into the arterial introducer. Ascent of a long introducer and deployment of a flexible covered endoprosthesis between the superficial femoral artery and the proximal part of the saphenous vein; intra stent remodeling by balloon. Passage of a devaluator through the entire saphenous vein.

Anterograde puncture of the low popliteal recipient artery or leg artery and placement of a long guide. Reversal of the venous introducer, tunneling of the guide under the skin and recovery in the venous introducer, deployment of a covered stent making the junction between the vein and the recipient artery.

Termino-terminal process: as described. An improvement to existing stents consists of providing them with pins or hooks, at best a few millimeters from their end, intended to strengthen the support between the stents, or with the donor or recipient vessels.

The end portion of the stent may benefit from having an eversion to increase the radial force during nesting.

Termino-lateral process: The end of the endoprosthesis has one end, covered or uncovered, either producing a radial crown opening perpendicular to the major axis of the endoprosthesis, or a shape molding an anastomotic junction. This end will ideally be in shape memory materials allowing its positioning in a thin cylindrical launcher, and its deployment.

In a certain technical form, it can be envisaged to effect the strengthening of the anastomosis by the addition of a cylindrical stent at one or more junctions. Other characteristics and advantages of the invention will emerge on reading the attached presentation.

Claims

1. Percutaneous bridging method between an upstream arterial zone and a downstream arterial zone situated respectively upstream and downstream of an obstructed, permeable or injured part of an artery affected by a vascular network of a human or animal patient, the process comprising:  placing a working wire guide in such a way that the working wire guide passes through a working orifice through a wall of a blood vessel of the vascular network, crosses through an arterial orifice upstream an arterial wall of the arterial zone upstream, passes through an arterial orifice downstream an arterial wall of the arterial area downstream, travels in the vascular network between the working orifice and the arterial orifice upstream, travels out of the vascular network between the arterial orifice upstream and the orifice downstream artery and travels in the downstream arterial zone between the downstream artery orifice and a downstream end of the wire guide; then a release of a downstream endoprosthesis portion in the downstream arterial region, followed by a release of an upstream endoprosthesis portion in the upstream arterial region, the upstream endoprosthesis portion being connected without disjunction to the portion d downstream endoprosthesis, the upstream endoprosthesis and downstream endoprosthesis portions having been introduced through the working orifice and having traveled along the working wire guide. 2. Method according to claim 1, comprising: percutaneous placement of a tubular working introducer in such a way that the tubular working introducer surrounds the wired working guide, and the working introducer passes through the wall of the network blood vessel through the working orifice vascular, crosses through the arterial opening upstream the arterial wall of the upstream arterial zone, crosses through the arterial opening downstream the arterial wall of the downstream arterial area, travels in the vascular network between the working orifice and the arterial opening upstream, travels out of the vascular network between the upstream arterial opening and the downstream arterial opening and travels in the arterial zone downstream between the downstream arterial orifice and a downstream end of the working introducer;  the upstream endoprosthesis portion and the downstream endoprosthesis portion being positioned, before the release, in the working introducer, the release of the downstream endoprosthesis portion and the release of the upstream endoprosthesis portion following a retraction of the downstream end of the working introducer. 3. Method according to claim 2, in which the upstream endoprosthesis portion and the downstream endoprosthesis portion are conveyed from the arterial orifice of entry into the working introducer after the percutaneous placement of the introducer. job. 4. The method of claim 2, wherein the upstream stent portion and the downstream stent portion are positioned in the working introducer before the percutaneous placement of the working introducer. 5. Method according to any one of claims 1 to 4, in which the installation of a working wire guide comprises a subcutaneous, supramental, or anatomical tunneling of the working wire guide between the upstream arterial orifice and the downstream artery orifice. 6. Method according to any one of claims 1 to 5, wherein the establishment of the working wire guide includes the introduction of the working wire guide into the downstream arterial zone through the downstream arterial orifice, then the introduction of the working wire guide through the upstream arterial orifice in the upstream arterial zone and its path to the working orifice. 7. Method according to any one of claims 1 to 5, wherein the establishment of the working wire guide comprises a transcutaneous setting of the working wire guide between the working orifice and the upstream arterial orifice then l introduction of the working wire guide into the downstream arterial zone through the downstream arterial orifice. 8. The method of claim 7, wherein the transcutaneous establishment of the working wire guide between the working orifice and the upstream arterial orifice is carried out by introducing the working wire guide through the working orifice. 9. The method of claim 7, wherein the transcutaneous establishment of the working wire guide between the working orifice and the upstream artery orifice is carried out by introducing the working wire guide through the upstream arterial orifice. 10. Method according to any one of claims 1 to 9, in which the upstream endoprosthesis portion is connected without disjunction to the downstream endoprosthesis portion directly by an intermediate portion of endoprosthesis constituting a single endoprosthesis with the portion of Upstream stent and the downstream stent portion. 1 1. A method according to any one of claims 1 to 9, in which the upstream stent portion is connected without disjunction to the downstream stent portion by a tubular fitting between the upstream stent section and the downstream stent section. 12. Method according to any one of claims 1 to 9, in which the upstream endoprosthesis portion is connected without disjunction to the downstream endoprosthesis portion by a tubular fitting between the upstream endoprosthesis section and an upstream end of a set of one or more intermediate stents and a tubular fitting between the downstream endoprosthesis section and a downstream end of the set of one or more intermediate stents, the intermediate stents being fitted into each other. 13. Method according to any one of claims 11 to 12, in which the fitting (s) are carried out between two superimposed end parts of two adjacent stent sections, the two end parts having a generally cylindrical tubular shape, at least one of the two parts ends being provided with asperities, for example hooks, pins or bosses, coming to anchor in or through the other end part. 14. The method of claim 13, wherein to anchor the asperities of one of the two end parts in the other end part, a balloon is inflated which allows the two end parts to be joined radially one against the other. 15. Method according to any one of the preceding claims, in which the downstream endoprosthesis portion comprises a terminolateral endoprosthesis portion, preferably having a flared end portion deploying around the downstream arterial orifice inside of a vessel of the downstream arterial zone, and a tubular lateral part crossing the downstream arterial orifice. 16. Method according to any one of the preceding claims, in which the upstream endoprosthesis portion includes a terminolateral endoprosthesis portion, preferably having a flared end portion extending around the upstream arterial orifice inside a vessel of the upstream arterial zone, and a tubular lateral part crossing the upstream arterial orifice. 17. Method according to any one of the preceding claims, in which the affected artery and the upstream and downstream arterial zones are located homolaterally downstream of a bifurcation of a common artery, also supplying a contralateral artery constituting the vessel. blood. 18. The method of claim 17, wherein the upstream arterial zone is the homolateral superficial femoral artery, preferably 3 to 10 cm downstream from the femoral bifurcation, the downstream arterial zone being the high or low popliteal artery, the vessel preferably being the contralateral common femoral artery. 19. Method according to any one of claims 1 to 16, in which the upstream arterial zone is the common femoral artery and the downstream arterial zone is a more distal artery. 20. Method according to any one of claims 1 to 16, in which the bypass is an interfemoral bypass, an aortofemoral bypass, or an iliofemoral bypass. 21. Portion of end-to-side endoprosthesis, comprising a flared end portion capable of deploying inside a blood vessel, around an orifice formed in a wall of the blood vessel, being pressed against the wall of the blood vessel around the orifice, and a tubular lateral part capable of passing through the orifice. 22. Set of two stent sections, having two end portions which can be superimposed to form a fitting, the two end parts having a generally tubular shape, at least one of the two end parts being provided with roughness, for example of hooks, pins or bosses, capable of being anchored in or through the other end part. 23. The assembly of claim 22, wherein the asperities project radially outward from an outer face of said one of the two end portions, and are intended to be anchored in or through an inner radial face from the other end part. 24. The assembly of claim 22, wherein the asperities protrude radially inward from an inner face of said one of the two end portions, and are intended to be anchored in or through an outer radial face from the other end part. 25. An assembly according to any one of claims 22 to 24, in which the other of the two end parts is also provided with asperities, for example hooks, pins or bosses, capable of being anchored in or through said one of the end parts.