WO2010128155A1

WO2010128155A1 - Surgical treatment system

Info

Publication number: WO2010128155A1
Application number: PCT/EP2010/056291
Authority: WO
Inventors: Alain Dibie
Original assignee: Alain Dibie
Priority date: 2009-05-07
Filing date: 2010-05-07
Publication date: 2010-11-11
Also published as: FR2945207A1

Abstract

The invention relates to a surgical treatment system for treating lesions on a bifurcation of a blood vessel from the main vessel, the system including: a first positioning instrument (10) having a distal end and a proximal end; and a second positioning instrument (20) having a distal end and a proximal end and comprising, at the distal end thereof, a means (13, 24, 30, 40, 42) for reversibly connecting the distal end of the second positioning instrument (20), enabling the two positioning instruments (10, 20) to be kept rigidly connected during the joint advance thereof through the blood vessel up to the bifurcation; the reversible connection means (13, 24, 30, 40, 42) including magnets that match magnets arranged at the distal end of the first positioning instrument (10).

Description

SURGICAL TREATMENT SYSTEM

The present invention relates to the field of systems for treating lesions on blood vessels. The present invention more specifically relates to a stent delivery system adapted for treating lesions on bifurcations of blood vessels.

The treatment of stenoses detected on coronary arteries is conventionally known by the introduction, by means of a guide, of endoprostheses formed of tubular bodies perforated with mesh and expandable on the site of stenosis.

Most often the expansion of these stents is caused by inflation of a balloon located inside the stents, the balloon being removed later. The usual stent delivery systems have already rendered great service. However, they do not give complete satisfaction.

In particular, the Applicant has found that they are not completely satisfactory when, as is common, the stenosis is located at a bifurcation of blood vessel. Indeed, in this case, the provision of two distinct stents intended to be placed respectively in the different branches of the bifurcation and whose relative positioning must be adjusted as closely as possible to cover at least the bifurcation zone, requires the use of two separate delivery systems during two procedures performed in parallel or successively.

For this, two installation techniques are known today.

A first is to put a first stent in the main vessel and partly in a first branch, then to bring a second stent from the second branch to the bifurcation. The second technique is to bring the two stents by the main vessel, then put in their respective branches.

The present invention relates to the second technique, in which the risks of cross-linking of the guides placing the stents and / or the balloons over the bifurcation zone are increased, thus making the treatment of stenosis sites on the bifurcations of blood vessels complex. .

An object of the invention is to provide a delivery system limiting the risk of crossing guides, for example between two laying instruments associated with two stents each for a branch of a vessel bifurcation.

It is also desirable to provide a system for easy installation of use and manufacturing while maintaining maximum efficiency. These objects are achieved within the scope of the present invention through a surgical treatment system for the treatment of lesions on a blood vessel bifurcation from the main vessel, the system comprising:

a first laying instrument having a distal end and a proximal end; and

a second delivery instrument having a distal end and a proximal end and having, at its distal end, means for reversibly connecting the distal end of the second laying instrument making it possible to hold the two laying instruments in place at the same time; their joint progression in the blood vessel to the bifurcation; the reversible connection means comprising complementary magnets of magnets arranged at the distal end of the first laying instrument. Some preferred but non-limiting aspects of the surgical treatment system according to the invention are the following: at least one of the magnets is in the form of a sheath which is fitted on the distal end of the corresponding laying instrument,

at least one of the magnets is a magnetically charged metal guide, at least one of the magnets is a magnetically charged radiopaque element,

at least one of the magnets is flexible,

at least one of the magnets is an electromagnet,

the facing faces of the magnets are of different polarity in order to temporarily link the respective distal ends of the first and second laying instruments during the installation of the system in the vessel,

the facing faces of the magnets are of the same polarity, and in that the magnet of one of the laying instruments comprises means for mechanically retaining the distal end of the other laying instrument in order to provisionally link the respective distal ends of the first and second laying instruments when placing the system in the vessel,

the magnets are a metal guide serving as a guiding element for the first instrument and a sheath fitted on the distal end of the second laying instrument, said sheath further comprising receiving means adapted to receive the distal end of the metal guide; , and

- The distal end of the metal guide is maintained in the receiving means of the sheath with a luer-lock type system disposed at the proximal end of said guide for maintaining fixed said guide.

The invention also proposes a method, particularly for the treatment of lesions on a blood vessel bifurcation, in particular for positioning at least one stent in the vessel, comprising the following steps: ι) providing a first laying instrument having a distal end and a proximal end, ii) providing a second delivery instrument having a distal end and a proximal end, iii) providing complementary magnets on the respective distal ends of the first and second delivery instruments, iv) provisionally linking the respective distal ends of the first and second delivery instruments. placing by means of said magnets, v) introducing into the vessel the first and second laying instruments, the distal ends of which are connected by means of the magnets, vi) positioning the laying instruments at the bifurcation, vii) separating the respective distal ends laying instruments by separating the magnets provided at said ends, vϋi) introduce one of the laying instruments in a first branch of the bifurcation, and the other laying instrument in the second branch.

According to a non-limiting aspect of the method according to the invention, one of the magnets is a magnetically charged metal guide, and the separation of the magnets of the first and second laying instruments respectively is achieved by replacing the guide with another unloaded guide or of inverse polarity (in relation to the polarity of the initial guide), in order to facilitate the installation of the laying instruments in their respective branches.

Other features, aims and advantages will appear better on reading the detailed description which follows, and with reference to the appended drawings given as non-limiting examples and in which:

FIG. 1 illustrates a first form of a surgical treatment system according to the invention;

FIG. 2 illustrates a second form of a surgical treatment system according to the invention;

FIG. 3 is a variant of the second embodiment of a surgical treatment system according to the invention, and FIG. 4 is a perspective view of an embodiment of a magnet according to the invention. A surgical treatment system according to the invention comprises a first and a second delivery instrument 10, 20 each having a distal end and a proximal end. Thereafter, "proximal" will designate a portion (eg, one end) that is near the operator, while "distal" will designate a portion that is remote from the operator.

The present invention will be described later in its application to lesion treatment systems on a blood vessel bifurcation. Nevertheless, the invention is not limited to this type of system, and can be applied to any surgical treatment system implementing two instruments whose distal ends must be temporarily linked, for example during their establishment.

Referring to the figures, which illustrate a stent delivery system on a blood bifurcation according to the international application WO 2007/090863, there is shown a first laying instrument 10 and a second laying instrument 20.

The first laying instrument 10 supports a first balloon 1 1 intended to dilate a stent 1 intended to be placed in a first branch of the bifurcation of a blood vessel to be treated.

This first balloon 1 1 is connected to an inflation lumen 12 which can receive a first guide member 13 for directing the balloon January 1 in the first branch of the bifurcation.

The second laying instrument 20 comprises a second balloon 21 adapted to be introduced into the second branch through an orifice 2 of the stent 10 and to expand the orifice 2 of said stent 1.

This second balloon 21 is also connected to an inflation lumen 22 which can receive a second guide element 23 intended to direct the balloon 22 into the second branch of the bifurcation. For example, the guide elements are composed of a wire extending along their respective laying instruments. Advantageously, one of the guide elements is a quick exchange guide while the other guide element is an auxiliary guide.

Here, a rapid exchange guide will be understood to mean a monorail guide that serves as the approach to the delivery system and remains in place for the entire duration of the placement of the stent, as opposed to the auxiliary guide, which is a guide. coaxial that can be replaced at any time.

In the remainder of the description and as illustrated in the drawings, the rapid exchange guide 23 is disposed in the inflation lumen 22 of the second setting instrument 20, while the auxiliary guide 13 (for example a mandrel) is arranged in the inflation light 12 of the first laying instrument 10.

According to the invention, the distal end of each of the laying instruments 10, 20 is provided with a magnet. In particular, the magnet is disposed either on a distal end of the inflation lumen 12, 22 of the instrument

10, 20 or on a distal portion of the guide member 13, 23 which emerges from said lumen 12, 22.

According to a first embodiment illustrated in Figure 1, the magnets are arranged on the laying instruments so that their facing faces are of different polarity. In other words, the polarity of the face of a first magnet which is opposite the second magnet is positive while the polarity of the face of the second magnet which is opposite the first magnet is negative. In this way, when the ends of the laying instruments are close to each other, or at least close enough for their magnetic fields to interfere, said ends move towards each other until they come into contact with each other. contact each other.

Thus, there is obtained a delivery system comprising two delivery instruments 10, 20 having their distal ends temporarily bonded, and able to move together in the vessel to be treated. In this embodiment, at least one of the magnets 24 has the shape of a magnetically charged sheath, which is fitted on the distal end of the corresponding laying instrument.

The sheath 24 may be traversed longitudinally from one side by the distal end of the laying instrument 20, or have a closed end, so that the end of the instrument is inserted in abutment in said sheath.

Preferably, when the magnet of the laying instrument 20 which is provided with the rapid exchange guide 23 is a sheath 24, it is traversed longitudinally by the guide 23 so as not to hinder the implementation of conventional laying methods.

Advantageously, the sleeve 24 is fixed on the instrument 20, for example by gluing means.

In this embodiment, the sleeve 24 may be flexible or rigid, depending on the materials used. For example, the sleeve 24 may be formed of a magnetizable metal spring.

As a variant, as illustrated in FIG. 1, only one of the magnets of the delivery system has the shape of a sleeve 24, whereas the other magnet is constituted by the guide element 13, 23 of the instrument. corresponding pose.

Advantageously, the magnet of the second laying instrument 20 is a sheath, and the magnet of the first laying instrument 10 is constituted by the auxiliary guide 13.

The auxiliary guide 13 is then a magnetically charged metal guide whose polarity is complementary to the polarity of the facing face of the sleeve 24 of the second laying instrument 20.

Of course, the sheath 24 may be placed on the laying instrument 10 provided with the auxiliary guide 13, while the magnet of the other laying instrument 20 will be constituted by the quick exchange guide 23. Likewise the two magnets can be in the form of a magnetically charged metal guide. The sheath 24 is then optional. When setting up the delivery system according to the invention in the bifurcation, the two laying instruments 10, 20 are advanced jointly in the main vessel to the level of the bifurcation.

For this, their distal ends are linked thanks to their respective magnets 24, 13 to avoid the crossing of the guides 13, 23.

When the distal ends of the delivery instruments 10 arrive at the bifurcation, said ends are separated so that each laying instrument can be positioned in a branch of the bifurcation according to traditional laying methods. The separation of the magnets can be done for example by exerting a shearing force at the interface between the two magnets, moving longitudinally the laying instruments 10, 20 relative to each other, or by rotation of one of the magnets around the longitudinal axis formed by the instrument on which it is placed. In the variant illustrated in FIG. 1, when the laying system is positioned at the bifurcation, the magnetically charged auxiliary guide 13 acting as a magnet for the first laying instrument 10 can be removed and replaced (according to a known method) by a guide element (not visible in the figures) not magnetically charged or of the same polarity as the opposite face of the magnet of the second laying instrument 20. Assuming that the auxiliary guide 13 is replaced by a guide of the same polarity that the magnet of the second laying instrument, when the new auxiliary guide reaches the level of the bifurcation, it is pushed by the magnet 24 of the second laying instrument 20. This separation by magnetic effect of the respective ends of the laying instruments 10, 20 at the entrance of the branches of the bifurcation facilitates the introduction of each installation instrument in its respective branch, and avoids further l crossing.

We will now describe a second embodiment of the surgical treatment system with reference to FIG. In this figure 2 is shown the same laying device that has been described with reference to the first embodiment illustrated in Figure 1. Only the magnets disposed at the respective distal ends of the first and second placement instruments 10, 20 differ. Indeed, the facing faces of the magnets of the first and second laying instruments are of the same polarity 10, 20, that is to say that they are both positively charged or both negatively charged.

Thus, when their magnetic fields interfere, the two magnets tend to repel each other and to separate the respective ends of the first and second laying instruments 10, 20.

However, when setting up the delivery system in the vessel, it is preferable that the distal ends of the laying instruments 10, 20 are linked to facilitate their insertion and to avoid their crossing. For this, one of the magnets comprises mechanical retaining means adapted to retain the distal end of the other laying instrument, such as a housing.

For example, as illustrated in FIG. 2, one of the magnets is a magnetically charged sleeve comprising two longitudinal channels 31, 32 adapted to receive the respective distal end of the first and second laying instruments 10, 20. It is However, it is fixed only on the distal end of one of the laying instruments, the distal end of the other laying instrument being removable.

Preferably, the channel 31 corresponding to the laying instrument provided with the rapid exchange guide 23 (here the second laying instrument 20) is passing through, so as not to hinder the installation of the system according to conventional methods, the other channel 31 may be clogged at its distal end.

According to an embodiment illustrated in FIG. 4, the sheath 30 is in the form of a metal sheet whose two opposite ends 33, 34 are wound on themselves so as to form the two channels 31, 32. Advantageously, each of the wound ends 33, 34 is arranged in such a way that it does not form a projection that can injure the arterial wall during the advancement of the placement instruments 10, 20. For example, an end 33 of the sheet is wound to form a tube (the wound end 33 of the sheet then being disposed inside the tube thus formed, so that it is not in contact with the arterial wall), while the opposite end 34 of the sheet is folded to come into contact with the outer wall of the tube and is held there in position to not form a cutting surface. For example, this end 34 may be welded to the outside surface of the wall of the tube in order to guarantee its positioning.

In practice, one of the channels of the sheath 30 is fixed, for example by gluing, on the distal end of the second delivery instrument 20, while the distal end of the first delivery instrument 10 is inserted temporarily into the other channel 31.

According to another variant, the inflation lumen 22 of one of the instruments, preferably the second instrument 20, is extended at its distal end by a tube 40, extending along the longitudinal axis of the instrument 20 The rapid exchange guide 23 then emerges from the free and open distal end of this tube 40. The tube 40 furthermore has, at its distal end, receiving means 41 loaded magnetically adapted to receive a complementary element 42. disposed on the distal end of the first delivery instrument 10.

The receiving means 41 are, for example, a sheath formed of a hollow auxiliary tube, one end of which is bevelled by bonding or welding at the free end of the tube 40 of the second laying instrument 20.

Advantageously, the face of the complementary element 42 which is opposite the auxiliary tube 41 is of the same polarity. The complementary element 42 may be a magnetically charged sleeve of complementary shape of the auxiliary tube 41, disposed on the distal portion of the inflation lumen 12, or simply be formed of the distal end of the second instrument, as illustrated in FIG. 3.

The complementary element 42 of the first instrument 10 may also be constituted by the auxiliary guide 13. Where appropriate, the auxiliary guide 13 is then a magnetically charged metal guide.

Thus, during the installation of the delivery system in the vessel, the distal ends of the laying instruments 10, 20 may cooperate and be temporarily linked, despite the identical polarity of the faces facing the magnets which tends to remove them one from the other. Then, once the delivery system has been guided to the entrance of the bifurcation, the distal end of the first delivery instrument 10 is withdrawn from the housing 31 of the sleeve 30 or the auxiliary tube 40, and departs under the magnetic repulsion force due to the polarity of the magnets.

The problem of crossing the guides 13, 23 during their introduction is also solved after their separation at the junction of the bifurcation, which further facilitates the introduction of the laying instruments 10, 20 in their respective branches .

In order to prevent the distal end of the first delivery instrument 10 from coming out of its housing 31 under the repulsive effect of the magnets during the installation of the delivery system, the auxiliary guide 13 can be held fixed with respect to the housing 31 through a luer lock type system, placed on the proximal end of the first laying instrument 10.

Again, the magnets can be interchanged, so that the magnet of the first laying instrument is a magnetically charged sheath or comprises receiving means of the auxiliary tube type, and that the magnet of the second laying instrument is constituted by its guide or be provided with the complementary element charged magnetically adapted to be introduced into the corresponding housing of the first magnet. Advantageously, and whatever the embodiment, at least one of the magnets is radiopaque, in order to facilitate the placement of the instruments of installation in the vessel. For example, the sleeve 24, 30, 40 magnetically loaded may be further radiopaque, or be integral with a radiopaque element.

Furthermore, at least one of the magnets may be an electromagnet, that is to say a magnet producing a magnetic field through the passage of a flow of an electric current, typically a wire through which an electric current flows. (Or a winding wound around a piece of ferromagnetic material and traversed by the flow of electric current). Also provided means for the flow of current in the electromagnet.

Finally, each magnet can be flexible or rigid, depending on the embodiment and the materials chosen.

This type of stent placement system on a bifurcation is given by way of non-limiting example, the invention can be implemented on other laying systems, such as that described in the international application WO 02/091951. Such a system comprises in fact a first and a second laying instrument respectively comprising a first and a second balloon, the respective distal ends of which may advantageously be temporarily connected by means of magnets in accordance with the present invention when they are put into place in a vessel.

This type of device can also be used during the implementation of the "kissing balloon" technique, in which two instruments equipped with a balloon are brought to a bifurcation of vessels to be inflated simultaneously. Indeed, by placing the magnets according to the invention at the distal end of each instrument, the risk of crossing the instrument guides are avoided, which facilitates among other things their implementation.

Claims

1. A surgical treatment system for treating lesions on a blood vessel bifurcation from the main vessel, the system comprising:

a first delivery instrument (10) having a distal end and a proximal end; and

a second delivery instrument (20) having a distal end and a proximal end and having, at its distal end, means (13, 24, 30, 40, 42) of reversible connection of the distal end of the second placing instrument (20) for holding the two insertion instruments (10, 20) together during their joint progression in the blood vessel to the bifurcation; characterized in that the reversible connection means (13, 24, 30, 40, 42) comprise complementary magnets of magnets arranged at the distal end of the first delivery instrument (10).

2. Surgical treatment system according to the preceding claim, characterized in that at least one of the magnets (24, 30, 40) has the shape of a sheath which is fitted on the distal end of the laying instrument. corresponding (10, 20).

3. Surgical treatment system according to one of the preceding claims, characterized in that at least one of the magnets (13, 23) is a magnetically charged metal guide.

4. Surgical treatment system according to one of the preceding claims, characterized in that at least one of the magnets (24, 30, 40) is a radiopaque element magnetically charged.

5. Surgical treatment system according to one of the preceding claims, characterized in that at least one of the magnets (13, 24, 30, 40) is flexible.

6. Surgical treatment system according to one of the preceding claims, characterized in that at least one of the magnets (13, 23, 24, 30, 40) is an electromagnet.

7. Surgical treatment system according to one of the preceding claims, characterized in that the opposite faces of the magnets (13, 24) are of different polarity in order to temporarily link the respective distal ends of the first and second laying instruments (10). , 20) when setting up the system in the vessel.

8. Surgical treatment system according to one of claims 1 to 6, characterized in that the facing faces of the magnets (13, 31, 40, 42) are of the same polarity, and in that the magnet (30, 40) of one of the delivery instrument (20) includes mechanical retaining means (41) of the distal end (42) of the other delivery instrument (10) for temporarily bridging the respective distal ends of the first and second laying instrument (10, 20) when placing the system in the vessel.

9. Processing system according to the preceding claim, characterized in that the magnets are a metal guide (13, 23) serving as a guide element to the first instrument (10) and a sleeve (30, 40) fitted on the end distal of the second delivery instrument (20), said sleeve further comprising receiving means (32, 41) adapted to receive the distal end of the metal guide (13, 23).

10. Processing system according to the preceding claim, characterized in that the distal end of the metal guide (13, 23) is maintained in the receiving means of the sleeve (31, 41) by means of a luer-lock type system arranged at the proximal end of said guide for holding said guide fixed.