Surgical instrument for fixing soft tissue

ES 2 346 554 T3

DESCRIPTION

Soft tissue fixation surgical instrument.

The present invention relates to a surgical instrument, which allows, percutaneously, the fixation of two areas of soft tissue, mainly distant from each other, to each other. This instrument is intended, in particular, for the "reconstruction" of heart valves, mainly the mitral valve, or for the treatment of any malformation of a heart septum.

A pathology of the mitral valve of a heart, called “mitral regurgitation”, consists in that the valve does not close properly, that is to say in a tight way and, therefore, it no longer plays its role as an anti-reflux flap between the left atrium and the left ventricle.

In this case, it is necessary to proceed to a repair surgery of this valve. According to the current technique, the sternum is serrated (sternotomy) and the rib cage is open, to approach the heart. The patient is then placed in extracorporeal blood circulation and, once the heart has stopped, the heart chambers are opened to directly access the mitral valve, generally through the left atrium.

In this case, an adequate treatment of this valve is carried out, mainly by annuloplasty or, more recently, by suturing the free edge of the valve called "anterior" with the free edge of the valve called "posterior" in the corresponding area. to mitral regurgitation.

This operative technique has the drawbacks of being particularly complex and difficult to perform, the need for general anesthesia of the patient, a sternotomy and a heart arrest, replaced by extracorporeal circulation. The latter implies the use of anticoagulants at high doses during the intervention. On the other hand, this technique induces a safe operative risk, in particular a risk of myocardial infarction and hemorrhage.

Publication EP 0558031 discloses a surgical apparatus that serves to carry out the fixation to each other of two portions of body skin tissue, which is composed of: a pair of opposite elongated organs, which are provided with jaws, which can be brought together in a position of mutual approximation, in order to engage two portions of body tissue placed within the membranes, and a plurality of removable ligatures rod-like for penetrating body tissues in order to effect fixation of the body tissue portions to each other.

Publication WO 94/18893 discloses a retractor and a dissector to be used in the case of a patient, who has one or more articulated organs capable of holding and stretching the tissue.

The present invention seeks to remedy these drawbacks by providing a surgical instrument that allows, in a general way, to fix percutaneously two areas of soft tissue normally distant from each other and, in the aforementioned particular application, which consists in the fixation of an area of ​​the Free edge of the anterior mitral valve with a zone of the free edge of the posterior mitral valve.

In accordance with the present invention, there is provided an instrument such as that described in claim 1.

In this way, the instrument according to the invention makes it possible to hold, approximate and fix, percutaneously, the two areas of tissue, simply by manipulating, from outside the patient's body, the different organs that comprise this instrument.

Preferably, the tube, the elongated organs and the aforementioned stem (s) have such flexibility that the instrument can be inserted, percutaneously, into a heart to allow the treatment of the valves of a heart valve, mainly the mitral valve; each of said elongated members is made of a material exhibiting elastic flexibility, and comprises a distal end portion that normally diverges from the longitudinal axis of the elongated member; the two elongated members are axially movable relative to the tube, between a retraction position in this tube, in which said distal end portions are elastically deformed in such a way that the distal ends of said members are close to each other and, a extension position, in which these distal limb portions regain their neutral shape and, as a consequence, diverge from each other, in order to reach the proximity of the tissues, in order to carry out the subjection of the same.

Advantageously, the elongated organs comprise means that allow their distal extremities to be either active, with a view to clamping the tissue areas, or inactive, to prevent this clamping and thus facilitate insertion, displacement or removal. instrument removal.

Each elongated member can be made up of a stem made of elastic material, with a recurved distal end and / or shaped like a harpoon, and an inserted sheath that can slide axially over this stem, being able to cover said sheath, in an advanced position, said distal extremity and be retracted in relation to this distal extremity, in order, in a reclined position, to uncover it.

According to a variant embodiment, each elongated member can be constituted by a tube connected with a device for placing the internal volume of this tube under vacuum. This placing in depression makes it possible to hold the corresponding tissue area, while the connection to the open air of this volume makes it possible to release the tissue, without damaging it. The distal end of the elongated member advantageously has a flared shape in this case, which ensures a clamping surface of efficient dimensions.

According to a variant embodiment, the instrument comprises two stapling members, the first of which is positioned in order to be fixed on the distal side of the tissues and the second of which, designed to be fixed on the proximal side of the tissues, is located between said first stapling member and the member that forms the abutment.

The two stapling members can thus be placed on either side of the tissues to be joined and can be pressed against said stop member, to ensure the perfect fixation of the tissues.

For your good understanding, the invention has been described again below with reference to the attached schematic drawing, which represents, by way of non-limiting examples, two preferred embodiments of the instrument to which it refers.

ES 2 346 554 T3

Figure 1 is a longitudinal section view of a heart, whose mitral valve does not close properly and must be treated by means of this instrument;

Figure 2 is a plan view of the mitral valve before treatment;

Figure 3 is a view of a mitral valve, similar to that of Figure 2, after treatment by suture, according to the classical technique;

Figure 4 is a view, similar to that of Figure 1, of a heart, into which the instrument according to the invention has been inserted;

Figure 5 is a view of the distal end of the instrument, on an enlarged scale and in longitudinal section;

Figure 6 is a view of this distal end, according to line VI-VI of Figure 5;

Figures 7 and 8 are views similar to that of Figure 5, in two different phases of use of the instrument;

Figure 9 is a view similar to that of Figure 2 of the mitral valve, after the treatment carried out by means of said instrument;

Figure 10 is a view of this valve according to the line XX of Figure 9, and Figure 11 is a view similar to that of Figure 5 of the instrument according to a second embodiment.

Figure 1 shows a heart C, whose mitral valve M shows poor coaptation of the valves M1, M2, in such a way that this valve M does not close properly, that is, in a tight manner, and therefore no longer plays its role. anti-reverse flap between the left atrium O and the left ventricle V.

According to a classic treatment technique, after sternotomy and opening of the rib cage, the patient is placed in extracorporeal blood circulation. The heart is stopped and the cardiac chambers are opened to directly approach valve M in order to suture the opposite free edges of the two valves M1, M2, as shown in Figures 2 and 3.

This fixing of the M1, M2 valves to each other makes it possible to restore a satisfactory coaptation of these M1, M2 valves, and therefore the restoration of the tightness of the M valve.

Figures 4 to 8 show an instrument 1, which makes it possible to operate, percutaneously, such a fixation of the valves M1, M2 to each other.

This instrument 1 comprises an outer tube 2, an axial guide wire 3, two elongated members 4 and a stapling device 5. The set is flexible enough to be able to be introduced percutaneously into the heart C, through the vena cava Ve and through the intra-atrial septum S, in such a way that wire 3 is introduced through the valve M and that the distal end of tube 2 is located in the left atrium 0, in front of this valve M.

Each of the elongated members 4 has a distal end portion 4a, normally having a curved shape and comprising a stem 10, made of relatively rigid but elastic material, mainly made of metal, and a sheath 11, mainly made of synthetic material. .

The distal end 10a and stem 10 are steely and roughly harpoon-shaped.

The sheath 11 is inserted into the stem 10 and can slide relative to it in such a way that in an advanced position, shown in the left part of Figure 5, it covers the end 10a and, in a reclined position, shown in the right of figure 5, discover this same extremity 10a.

The elongated members 4 are of such length that they extend beyond the end close to that of the tube 2. They can be displaced, in this way, axially relative to the tube 2 between a retraction position, which allows a mutual approach of the extremities 10a (Figures 7 and 8) and an extension position, which allows a mutual distancing of these same extremities 10a (Figure 5).

The stapling device 5 comprises three concentric tubular rods 15, 16, 17 inserted on the thread 3, which can slide relative to it and relative to each other.

The inner stem 15 is connected to a disc 20 through a divisible zone 21, the whole being of molded synthetic material. This disc 20 is axially drilled to allow the passage of the wire 3 and comprises a staple 22. The lateral branches 22a of this staple 22 project from the proximal face 20a of the disc 20 and the central branch 22b, which comprises a central ring for the passage of the thread 3 is embedded in the material that constitutes the disk 20.

The intermediate stem 16 is also connected through a divisible area 23 with a disk 24, comprising two staples 25. The lateral branches 25a of these staples protrude from the distal face 24a of this disk 24 and their central branches are embedded in the matter that constitutes disk 24.

The latter also comprises two diametrically opposite lateral notches 26, to allow the elongated members 4 to pass.

The outer stem 17 has, for its part, an elongated distal end 17a suitable for bearing against the proximal face of the disc 24.

Each of these rods 15, 16, 17 protrudes beyond the proximal end of the tube 2, so that it can be moved by the operator. Means for positioning, relative displacement and traction of these rods have been provided, such as handles or systems with bolts-nuts on the proximal ends of these rods, to allow pulling on the rod 15 while maintaining the stem 17 in a determined position relative to tube 2, and then on stem 16, the stem 17 also being held in a determined position relative to tube 2.

In practice, wire 3 is introduced, firstly, through the vena cava Ve, the intra-atrial septum S and then through the mitral valve M, under ultrasound or fluoroscopic control, and then tube 2 and the different Organs, which are contained therein, are inserted into the vein Ve, through the septum S, until the distal end of tube 2 is in front of the mitral valve M.

At the time of this introduction, the disk 20 is held substantially at the height of the opening of the tube 2, allowing its closure, the organs 4 being retracted in such a way that their distal ends are located in the notches 26.

ES 2 346 554 T3

When the distal end of the tube 2 is in a suitable position, the stem 15 is displaced to guide the disc 20 past the valves M1, M2, and then the members 4 are slid towards their position of extension, as shown in the Figure 5. These members 4 are then deployed by elasticity, in such a way that their distal end portions 4a move away from each other. The distal ends 10a of the stems 10 are then in the vicinity of the valves M1, M2.

The sheaths 11 are then retracted in relation to the stems 10, to reveal the extremities 10a, and then the latter are nailed respectively into the corresponding valve M1 or M2.

The tube 2 is then advanced towards the mitral valve M, which has the effect, as shown in figure 7, the approximation of the portions 4a to each other and, therefore, the approximation of the free edges of the two valves M1, M2.

A traction is made through the stem 15, keeping the stem 17 in position relative to the tube 2, successively in order to make the branches 22a and 25a of the clips 22, 25 penetrate into the valves M1, M2, to deform these branches 22a and 25a against the respective facing walls 20a, 24a of the discs 20, 24 and break the divisible zone 21. This break corresponds to a sufficient deformation of the branches of the staples to ensure a perfect mutual fixing of the valves M1, M2.

The sheaths 11 are then moved relative to the stems 10 to bear against the valves M1, M2, in order to allow easy separation of the extremities 10a and the valves M1, M2, and then a traction is operated on the stem 16 while holding stem 17 in position, in order to break zone 23.

The valves M1, M2 are then stapled to each other by their free edge, as seen in Figures 9 and 10.

Figure 11 shows a variant embodiment in which the stems 10 and the sheaths 11 have been replaced by two catheters 40, the distal ends 40a of which are flared. These catheters 40 protrude from the proximal end of tube 2 and are connected with syringes to depress its internal volume. Clamping or releasing the valves M1, M2 is then operated respectively by placing the internal volume of the catheters 40 in depression or overpressure. The flared ends 40a make it possible to ensure a sufficient gripping surface on the valves M1, M2. These are flexible in structure in order to be able to be inserted, slightly folding back, between the wall of the tube 2 and two side cut panels of the disk 20. As for the rest, the other elements of this instrument are similar to those that have already been described, and have been designated with the same reference numbers.

It should be noted that the invention is not limited to the embodiment described above by way of example. In this way, the extremities 10a can be curved in the shape of a "J" in their neutral form, to engage the tissues, then allowing the sheaths 11, when covering these extremities, to be deformed to keep them in a non-recurved state; the members 4 and the fixing means may be placed in separate tubes; instrument 1 being able to be introduced by both venous and arterial routes.