WO2014108622A1

WO2014108622A1 - Surgical device having radial expansion

Info

Publication number: WO2014108622A1
Application number: PCT/FR2014/000002
Authority: WO
Inventors: Giacomo Bersano; Massimo Bobbio; Pierpaolo TERRAGNI
Original assignee: Active Innovation Management Sarl
Priority date: 2013-01-08
Filing date: 2014-01-07
Publication date: 2014-07-17
Also published as: FR3000661A1

Abstract

The invention relates to a surgical device (1) for making an opening in the trachea, which has a tip (2) for perforating the tissue of the trachea, extending along a main axis (3). Said device is characterised in that the tip (2) has at least one mobile element (4), perpendicularly movable to the main axis (3), such as to cause a radial expansion of said tip (2).

Description

SURGICAL DEVICE WITH RADIAL EXPANSION

DESCRIPTION

The present invention is in the field of surgical equipment and relates to a device for making an opening in the trachea.

Such devices are necessary to make an orifice in the trachea, in particular to provide extra-corporal ventilation. This orifice can then be traversed by a cannula, inflow and outflow pipes, and it is therefore necessary to obtain an orifice of adequate dimensions, without hurting the patient while ensuring a practical procedure for the surgeon. . Devices of this type may optionally expand an orifice initially made in the context of a preliminary operation.

EPI 203594 discloses a surgical device of this type comprising essentially a cylindrical body, possibly threaded, at the end of which is a conical end provided with a helical thread to facilitate insertion and expansion.

US2003114871 discloses a device with a sharp tip, placed in a hollow body. An orifice is made thanks to the sharp point, the hollow body being also introduced through a conical portion whose sharp tip forms the end. After introduction, the tip is removed, releasing the interior of the hollow body for the subsequent stages of the procedure.

US2004 / 0087991 discloses a device whose section grows gradually, from a point that can pierce the tissue to a sufficiently large section, the axis of the device being shaped wave to ensure good ergonomics to the surgeon.

However, the various embodiments of the state of the art have all or some of the following disadvantages: poor ergonomics for the surgeon, complicated apparatus, low possibility of dilation of the tissues, need to make the orifice several times.

The invention aims at bearing at least a portion and preferably all the aforementioned drawbacks and proposes for this purpose to achieve radial expansion of the tip inserted into the trachea through at least one piece that includes the tip and which is radially movable. We thus obtain a Robust device with a simple design, easy to handle and allowing efficient dilation of the tracheal tissues.

Thus, the invention relates to a surgical device for making an opening in the trachea, which has a tip for perforating the tissue of the trachea, extending along a main axis.

This device is characterized in that the tip has at least one movable element displaceable perpendicularly to the main axis, so as to cause radial expansion of said tip.

The invention will now be described in detail, with reference to two distinct and non-limiting embodiments, with the aid of the following figures:

- Figure 1 is a perspective view of the entire surgical device;

FIG. 2 shows a perspective view of a surgical device according to the invention, but comprising only one displaceable element;

FIG. 3 is a detailed view of the end of the tip;

FIG. 4 is a view of the base of the surgical device;

- Figure 5 shows more particularly the radial linear guide in the base;

- Figure 6 shows the radial linear guide with a movable element installed;

- Figure 7 shows the control member with its helical rib;

- Figure 8 specifically shows the helical rib of the control member;

- Figure 9 shows the control member seen from the side;

- Figure 10 shows the cap mounted on the end of the control member;

- Figure 11 shows a movable element;

FIG. 12 shows the rod that can be used to retract the displaceable elements therefrom, and

- Figure 13 shows an alternative kinematics.

The invention therefore relates to a surgical device 1 for making an opening in the trachea, which has at least one tip 2 for perforating the tissue of the trachea, extending along a main axis 3. In the drawings appended and the embodiments described below, a single tip 2 is described. Of course, the surgical device 1 could be designed to so as to present more than one point 2, for example positioned opposite to each other or offset and oriented in the same direction, for example.

As described above, this tool makes it possible to perforate the trachea, and thus to make a first small orifice using the free end of the tip 2, then to enlarge said orifice created for then insert, after removal, other medical devices, in particular a cannula for breathing apparatus. It is therefore the end of the tip 2 which is pressed against the trachea to make a first orifice, and the tip 2 penetrates the trachea through this opening. A radial expansion of the tip 2, described below, then makes it possible to enlarge the orifice.

This point 2 extends along a main axis 3, linear, and is intended to be driven into the trachea by an insertion movement essentially along this main axis 3. The tip 2 therefore advantageously has a shape at less locally conical at its free end, the tip of the tip 2 being preferably sharp enough and sharp enough to easily incise the trachea.

According to the invention, the tip 2 has at least one movable element 4, movable perpendicularly to the main axis 3, so as to cause a radial expansion of said tip 2. Thus, the incision made by the tip 2 in the trachea is subsequently enlarged by causing a radial expansion of the tip 2 which passes through the tissue. Once the ₄ end of the tip 2 has torn the tissue of the trachea, the device is slightly pressed into the trachea, the tip end 2 s' thus pressing right inside of the trachea. This is no longer the free end of the tip 2 which is in contact with the tissue of the trachea, but the body of the tip 2. Enlarge the hole obtained by the insertion of the tip 2 is then causing a radial enlargement of the tip 2. The section of the tip 2, around the main axis 3 is gradually increased so as to force the deformation of the tracheal tissue and to increase the size of this orifice.

This increase in the outer diameter of the tip 2 is therefore done thanks to at least one movable element 4, movable perpendicularly to the main axis 3, preferably several movable elements 4 regularly distributed around the periphery of the tip 2, present and retracted in the heart of the tip 2 at the time of its insertion into the trachea so as to facilitate said insertion, which moves away or progressively away from the main axis 3 to generate a radial expansion of the tip 2, that is to say an increase in the section of the tip 2, at its contact with the tissue of the trachea through which it passes. Once the tip 2 passes through the tissue of the trachea and its free end is in the trachea itself, the movable elements 4 are moved perpendicular to the main axis 3, thereby increasing the section occupied by the trachea. tip 2 at the level of its contact with the tissue of the trachea. The movable elements 4 are therefore displaceable relative to the remainder of the tip 2 at least perpendicularly to the main axis 3.

The set of movable elements 4 can define the entire section of the tip 2, their succession thereby forming a complete turn, or only to define a portion, their discontinuous succession thereby forming a part of the periphery of the tip 2. In the examples described here, the tip 2 comprises three movable elements 4, but it is conceivable that a single mobile element 4 is used. In addition, the tip 2 may either consist exclusively of these movable elements 4, as shown in Figure 13, or have a base in which are formed housing for accommodating the movable elements 4. This base can be part of the rod 9 described later.

Thus, the tip 2 is fine when it is necessary to insert it through the tissue of the trachea to create a first orifice, which is not traumatic for the tissue, but can then be enlarged to remove the tissue view of the placement of a larger cannula, after removal of the surgical device 1. For insertion into the trachea, the at least one movable element 4 is preferably retracted into the heart of the tip 2, while it is pulled out to cause radial expansion of the tip and distort the tracheal tissue.

According to a possible additional feature of the surgical device 1, it comprises, for the at least one tip (2), at least one drive kinematic chain itself comprising a control member 5, on which a user can act to move the to minus a movable element 4 and thus modify the dimensions of the tip 2 perpendicularly to the main axis 3. The action of the user on the control member 5 thus allows to move the at least one movable element 4 by compared to the main axis 3 and thus to cause the radial expansion of the tip 2. It is thus possible to imagine that the at least one movable element 4 is displaced by means of two different kinematic chains, one using the translation of a tapered slide, the other using the rotation of a provided part. of a helical rib, as described later. It is also possible, for example, to have a variable screw pitch for the displacement of this sliding or for the helical rib. The different control kinematic chains may have parts in common, and differentiate themselves by the amplitude of the movement generated at the mobile element 4, or by the nature of the movement to be applied to the control member 5 to create the movement: rotation, translation, etc.

As shown in Figures 1 and 2, the surgical device 1 is in the form of a first substantially cylindrical part about the main axis 3 as an axis of symmetry, the tip 2 being in the extension of this first piece cylindrical. The cylindrical part is essentially formed of the control member 5 and the support 6 described below.

In particular embodiments, the surgical device 1 comprises a base 6, from which the tip 2 extends and relative to which the control member 5 is rotatable, in particular around the main axis 3, 1 radial expansion of the tip 2 being caused by the rotation, relative to the base 6, of the control member 5, the tip 2 remaining preferentially fixed relative to the base 6. The tip 2 is therefore not necessarily driven in rotation when actuating the control member 5, and only the movable elements 4 are moved, perpendicular to the main axis 3 to cause an increase in the section of the tip 2. Thus, when the control member 5 is turned around the main axis 3, the at least one movable element 4 moves perpendicularly to the main axis 3, then leaving the base of the tip 2 and housing in which they are retracted or simply away of the principal x 3. The movement is of course preferentially reversible: a rotation in the opposite direction retracts again the at least one movable element 4.

The control member 5 thus takes the form of a rotatable piece relative to a base 6, the latter being at the base of the tip 2, which is partially integral. The rotation of the control member 5 around the main axis 3 makes it possible to create the movement radial mobile elements 4, with a kinematic chain as one of the two described below.

It is particularly advantageous to use a rotational movement about the main axis 3, given the risk of injury caused by transverse movements, resulting from improper handling or manipulation ergonomic. In addition, the possible poor execution of a movement in the direction of the main axis 3 can cause the operator to hit the trachea.

For first embodiments, illustrated in particular in FIG. 13, the surgical device 1 has a slider 7 having a conical portion displaceable in translation along the main axis 3, the rotation of the control member 5 causing the displacement of said slider 7 along the main axis 3, the latter then pushing radially, perpendicularly to the main axis 3, by wedge effect, the at least one movable element 4.

The control member 5 then takes the form of a wheel having a threaded rod through which it can engrainer the slider 7, having a corresponding thread. The control member 5 is locked in translation along the main axis 3 in a part of the base 6, which also holds the slider 7 in rotation about the main axis 3. Thus, the rotation of the wheel forming the control member 5 creates a displacement of the slider 7 along the main axis 3, in the very heart of a part belonging to the base 6, and having an axial recess in which the slider 7 can circulate along the axis main 3 and for gripping the surgical device 1.

Thanks to the conical portion, at the end of the slider 7, the linear displacement of the latter in the direction of the main axis 3 is transformed into a movement of the at least one movable element 4 perpendicular to the main axis 3. In the example of Figure 13, three movable elements 4 form the tip 2, and each have a base, at the opposite of their free end for piercing the fabric, said base having an inclined plane for cooperation with the conical portion of the slider 7. The conical portion of the slider 7 thus comes into contact with this inclined plane, and the translational movement of the slider 7, in the direction of the main axis 3, is transformed into a movement of the at least one element displaceable 4 perpendicularly to this axis. The guides of the parts involved in the kinematics described above can of course be carried by other parts of the surgical device 1, the wheel forming the control member 5 being locked in translation but guided in rotation, the slider 7 cooperating by a screw thread with the control member 5, being locked in rotation around the main axis 3 but guided in a translation parallel to it, the at least one displaceable element 4 being guided perpendicularly to the main axis 3 by linear guidance 12 further described below.

In second embodiments, illustrated in particular in FIGS. 1 to 12, the control member 5 has a groove 8 in the form of a helix which extends in a plane substantially perpendicular to the main axis 3, the at less a movable element 4 having grooves complementary to those of said groove 8 for a fattening, so that the rotation of the control member 5 causes the radial displacement of the at least one movable element 4.

Thus, as shown in Figures 7 to 9, the control member 5 takes the form of a symmetrical ring about the main axis 3, having a surface perpendicular to said axis. This surface carries the helical rib, the groove of which therefore progressively deviates from the main axis 3. The at least one movable element 4 also has a base, the shape of which is complementary to at least one groove of the rib, preferably several adjacent. Thus, if the control member 5 is turned on itself about the main axis 3, the mobile element 4, engrained in the helical rib, will move perpendicularly to the main axis 3. In fact, the device 1 has a linear guide 12 for the at least one movable element 4, which prevents it from being rotated about the main axis 3 by the rotation of the control member 5.

As has been described above for each of the two kinematic chains, and according to an additional possible feature, the base 6 has a radial linear guide 12 for the at least one movable element 4, so as to guide it in its movement. radial expansion.

This linear guide 12, preventing the rotation of the at least one movable element 4 around the main axis 3 and allowing only a translation perpendicular to this axis, thus preferably takes, see FIGS. 5 and 6, the shape at least one groove made in the base 6 which is placed between the control member 5 and the tip 2, oriented perpendicular to the main axis 3, wherein the base of the movable member 4 is housed. In the case of Figure 5, wherein the surgical device 1 has a plurality of movable elements 4, namely three, these guide grooves are preferably arranged in a star, regularly.

Unlike the first embodiments mentioned above, the rotational movement of the control member 5 is here directly transformed into radial displacement of the displaceable element 4, whereas in the first kinematic, the rotation is transformed into translation parallel to the main axis 3, then in translation perpendicular thereto.

In some embodiments, and according to another possible additional feature, the device comprises a removable rigid rod 9, extending at the tip 2 and preferably forming its pointed end so as to pierce a body tissue, in particular the tissue of the trachea. This rod 9 extends between each of the two ends of the surgical device 1, and makes it possible to stiffen the assembly. Thus, unlike the embodiment of FIG. 13, it is not the moving elements 4 that must withstand the pressure exerted during the insertion of the tip 2 into the trachea, but only this rod 9. It is thus possible to achieve movable elements 4 which only the radial rigidity is high, and it is also possible to increase the number without penalizing the mechanical strength of the tip 2, which must support the insertion force in the trachea.

The advantage of using an additional rod 9 is also that it can itself bear the sharp end of the tip, whose role is to pierce the trachea. This free end to be the smallest possible to facilitate the incision, it can be very difficult to achieve with the mobile elements 4 directly, which will have even smaller dimensions. Another advantage is also that this rod can stiffen the tip 2 and thus relax the mechanical requirements for achieving the movable elements 4. However, as it is necessary to access the interior of the trachea, particularly for While passing a wire or internal vision devices, it is preferable to remove the rod 9 of the surgical device 1 once the tip 2 dilated. Given the fact that the rod 9 must be removable, the chirurigucal device 1 has the stops necessary to maintain sufficient position. Finally, so as not to disturb the natural ventilation of the patient once the stem 9 out of the surgical device 1, the latter is provided with a means for closing the opening 11 for passage of the rod 9, avoiding the flow of air through the opening created in the trachea. This closure means may be the cap mentioned elsewhere in this description, an adhesive cap, plug, or other.

In addition, preferably, the rod 9 has, for the at least one movable member 4, an axial groove 10 in which it can be retracted, this groove 10 extending in the direction of the main axis 3, see Figure 2. The movable element 4 thus takes the form of an elongate element, which can come into a corresponding recess of the rod 9, in the form of a groove 10. The movable element 4 is thus retracted into the very core of the rod 9, in the corresponding groove 10.

As shown in Figure 1, the control member 5 is rotatable relative to the base 6 around the main axis 3 of the tip 2, the rod 9 passing through the base 6 and the control member 5 and opening at an opening 11 thereof, located opposite the free end of the tip 2, said base 6 having a closure cap of said opening 11. The opening 11 is at one end. of the surgical device 1, opposite to the free end of the tip 2. The cap thus allows, once the rod 9 out of the surgical device 1 through the opening 11 to limit through this passage the air flow from the trachea towards outside.

Finally, according to yet another additional feature possible, the control member 5 and / or the base 6 have / have attachment zones that facilitate gripping and relative movement. It is thus advantageous to provide concave zones, as shown both in FIG. 2 and in FIG. 7, by means of which, by means of the lugs which are complementary to them, the base 6 can be firmly held, and the control member 5 correctly grasped to be rotated around the main axis 3.

The description of the two embodiments detailed above does not limit the scope of the claims to these two embodiments alone. Variations are possible, obviously possible.

Claims

Surgical device (1) for making an opening in the trachea, which has at least one point (2) for perforating the tracheal tissue, extending along a main axis (3), characterized in that the at least one tip (2) has at least one movable element (4) displaceable perpendicularly to the main axis (3), so as to cause a radial expansion of said tip (2), said at least one movable element ( 4) being present and retracted into the heart of the tip (2) at the time of insertion into the trachea so as to facilitate said insertion.

2. Surgical device (1) according to claim 1, characterized in that it comprises, for the at least one tip (2), at least one kinematic control chain itself comprising a control member (5), on which a user can act to move the at least one movable member (4) and thereby change the dimensions of the tip (2) perpendicular to the main axis (3).

3. Surgical device (1) according to any one of claims 1 or 2, characterized in that

it comprises a base (6), from which extends the tip (2) and relative to which the control member (5) is rotatable, in particular around the main axis (3), the expansion radial point (2) being caused by the rotation, relative to the base (6), the control member (5).

4. Surgical device (1) according to any one of claims 2 or 3, characterized in that

it has a slider (7) having a conical portion, displaceable in translation along the main axis (3), the rotation of the control member (5) causing the displacement of said slider (7) along the main axis (3), and pushing radially, perpendicularly to the main axis (3), by wedge effect, the at least one movable element (4).

5. Surgical device (1) according to any one of claims 2 or 3, characterized in that

the control member (5) has a groove (8) in the form of a helix extending in a plane substantially perpendicular to the main axis (3), the at least one movable element (4) having complementary grooves those of said groove (8) so that the rotation of the control member (5) causes the radial displacement of the at least one movable element (4).

6. Surgical device (1) according to any one of claims 2 to 5, characterized in that

the base (6) has a radial linear guide (12) for the at least one movable element (4), so as to guide them in their radial expansion movement.

7. Surgical device (1) according to any one of claims 1 to 6, characterized in that

the device comprises a removable rigid rod (9) extending at the tip (2) and forming its pointed end so as to pierce a body tissue, in particular the tissue of the trachea.

8. Surgical device (1) according to claim 7, characterized in that

the rod (9) has, for the at least one movable element (4), an axial groove (10) in which it can be retracted.

9. Surgical device (1) according to any one of claims 7 or 8, characterized in that

the control member (5) is rotatable relative to the base (6) around the main axis (3) of the tip (2), the rod (9) extending at the level of the body through control (5) and opens at an opening (11) thereof, located opposite the end of the tip (2), said base (6) having a closure cap of said opening (11).

10. Surgical device (1) according to any one of claims 2 to 9, characterized in that

the control member (5) and / or the base (6) have / have hooking zones that facilitate gripping and relative movement.