Valve for subcutaneous use and its external control device

IS 2 139 161 T3

DESCRIPTION

Subcutaneous valve and its external regulation device.

The present invention relates to a subcutaneous volvula intended for therapeutic applications and to its external regulation device that allows a passage or a distribution of liquid in prostheses or implanted systems to be modified through the skin tissues.

Among the therapeutic applications of the valve according to the present invention, mention may be made of the treatment of hydrocephalus, which consists of diverting the cephalo-lobe fluid contained in the ventrocles of the cranial cavity to any other place of resorption.

A known valve for this application is described in the French patent of the applicant company No. 81 05389.

A valve of this type comprises a body made up of a substantially cylindrical and flat internal chamber, an inlet conduit and an evacuation conduit made in the side wall of said chamber and capable of being respectively connected to a traode catheter and a catheter of liquid drainage, a rod-shaped rotor capable of rotating in said chamber around its central axis, a non-return valve made up of a ball and a cone-shaped seat at the internal end of the inlet duct, a semicircular laminar spring, fixed to said rotor, parallel to the side wall of the chamber and compressing the ball in its seat in such a way as to regulate and, if necessary, block the passage of the liquid in the chamber through the inlet duct, two fixed micro-magnets mounted on the rotor and arranged on either side of the central axis of the chamber, and means for locking the rotor in a determined position, the locking means comprising a protruding pin at one end of the rotor and cavities for receiving the pins made circularly in the side wall of the valve body, said cavities having a shape suitable for retaining these pins.

To the extent that the rotor comprises micro-magnets, it is possible, by means of a magnet that is placed in the vertical of the valve, to drag the rotor in rotation through the wall of the valve and the skin tissues that cover it when the valve was implanted. The rotor can be adjusted remotely and from the outside in its different locking positions, and consequently modify the pressure and the operating flow of the valve.

However, this type of valve with a magnetic rotor has the drawback of being able to be misadjusted under the action of a high-power external magnetic or electromagnetic field, such as that found in nuclear magnetic resonance imaging.

This drawback is very uncomfortable for carriers of valves of the aforementioned type who must have their valve adjusted again after each examination that uses techniques such as imaging by nuclear magnetic resonance imaging. Documents US-A-4 551 128 and US-A4 676 772 also show valves which are also actuated by a magnet.

The present invention aims to provide a subcutaoneal valve that cannot be misadjusted by an external magnetic field other than that which comes from a particular magnetic regulating device.

The object of the present invention is a subcutaneous valve intended for therapeutic applications that allows the external regulation of a liquid distribution, said valve comprising a body made up of a substantially cylindrical and flat internal chamber, an inlet conduit and an evacuation conduit made in the side wall of said chamber and capable of being respectively connected to a traode catheter and a liquid drainage catheter, a rotor capable of rotating in said chamber around its central axis, a non-return valve, such as a ball, formed at the internal end of the inlet duct, a curved laminar spring, preferably semicircular, fixed to said rotor, parallel to the side wall of the chamber and that compresses the valve in its seat so as to regulate, and if necessary block, the passage of liquid into the chamber through the inlet duct, two micro-magnets mounted on the rotor and arranged on either side of the central axis of the chamber and a means for locking the rotor in a specific position, characterized in that the micro-magnets of the rotor are linearly mobile in said rotor following a substantially west-radial direction , so as to actuate said locking means.

The rotor was advantageously constituted by an H-shaped bar whose lateral branches serve as guiding means for the movable micro-magnets.

The locking means preferably comprise a protruding pin on movable parts that each house a micro-magnet and cavities for receiving the pins made circularly in the chamber, said cavities having a suitable shape to retain said pins.

In a first embodiment of the valve according to the present invention, the mobile micro-magnets are arranged so that they attract each other, their facing faces being of opposite polarities and the cavities are made in the periphery of a central part of the upper or lower wall. of the valve body, the pins forming protruding on the respective movable parts perpendicular to said upper or lower wall.

The upper or lower wall of the valve body is advantageously constituted by a removable cover having said central part.

In a second embodiment of the valve according to the present invention, the mobile micro-magnets are of the same polarity and said cavities are made on the periphery of the chamber side wall, the pins forming radially protruding with respect to the respective mobile parts towards said side wall.

The object of the present invention is also a device for external regulation of the valve according to the present invention.

Following a first mode of realization, the dis2

ES 2 139 161 T3 positive external regulation according to the present invention, is made up of two magnets whose opposite faces have opposite polarities and a magnetic mass greater than those of the mobile micro-magnets, said magnets being mounted on a common support, preferably annular or horseshoe-shaped, and separated by a distance substantially equal to or greater than that which separates the outer poles of the two movable micro-magnets when the latter actuate the locking means.

Following a second mode of implementation, the external regulation device according to the present invention, is constituted by a circular succession of magnetized poles, mounted on a support, preferably annular, with the poles of equal polarity arranged diametrically two by two and separated by one. distance substantially equal to or greater than that which separates the outer poles of the two movable micro-magnets when the latter actuate the locking means.

Following a third embodiment, the external adjustment device according to the present invention comprises a support, preferably annular, and electromagnetic means mounted circularly on said support, and arranged radially in the direction of the receptacle cavities of the pins, said electromagnetic means being capable of sending sequences of coded electromagnetic pulses corresponding to the different locking positions of the rotor in the chamber.

To better understand the object of the present invention, I will describe below, by way of a purely illustrative and non-limiting example, several modes of realization represented in the attached drawings, in which:

figure 1 is a top view, partially in section, of a valve following a first embodiment of the invention,

- figure 2 is a sectional view along line II-II of the valve of figure 1,

Figure 3 is a view from above of a first embodiment of the external adjustment device according to the present invention arranged in the vertical of the valve of Figure 1,

Figure 4 is a top view, partially in section, of a valve following a second embodiment of the invention,

- figure 5 is a sectional view, following the line VV, of the valve of figure 4,

figure 6 is a side view of the valve of figure 4,

Figure 7 is a view from above of a second embodiment of the external adjustment device according to the present invention,

Figure 8 is a view from above of a third embodiment of the external adjustment device according to the present invention, arranged in the vertical of the valve of Figure 4.

Figure 1 shows a view from above of a valve body 1, without its upper cover 2, for greater clarity.

The valve body 1 is constituted by an upper cover 2 and a box 3.

The upper cover 2, represented in section in figure 2, has a substantially cylindrical central part 2a separated by a step from a flat part 2b in the form of a collar.

Cavities 4, represented in broken lines in Figures 1 and 3, are made on the periphery of the central part 2a.

The peripheral part of the collar 2b rests on an annular recess made in the upper end of the side wall 3a of the box 3.

The valve body 1 has a flat, cylindrical internal chamber 5 made between the lower wall 3b, the side wall 3a of the box 3 and the upper cover 2.

An inlet duct 6 and an evacuation duct 7 are made in the side wall 3a of the box 3, the internal ends of said ducts 6 and 7 being arranged diametrically in the chamber 5.

The inlet conduit 6 and the evacuation conduit 7 are capable of being respectively connected to a trada catheter and a liquid drainage catheter, not shown in the drawing.

A rotor 8, made up of an H-shaped bar, is rotatably mounted in chamber 5 around its central axis 9. Stop elements 21 are provided, projecting from the lower wall 3b of casing 3, to limit the Rotational displacement of the rotor 8.

The rotor 8 can advantageously be made of plastic material.

The rotor 8 has lateral branches 8a that serve as guiding means, on either side of the central axis 9, to moving parts 10 and 11 that each house a micro-magnet 12 and 13, the faces of the micro-magnets being facing each other. opposite polarities (N and S).

The moving parts 10 and 11 can move linearly in the rotor 8 in a substantially radial direction thereof so as to actuate locking means.

The locking means are constituted by cylindrical pins 10a and 11a, respectively, protruding from the moving parts 10 and 11 and from the circular succession of cavities 4 suitable for receiving said pins 10a and 11a.

The valve body 1 comprises a non-return valve constituted by a ball 14 and a cone-shaped seat 15, arranged at the internal end of the inlet duct 6.

A semicircular leaf spring 16 is fixed to a lateral branch 8a of the rotor 8, it is parallel to the lateral wall 3a of the chamber 5 and compresses the ball 14 in its seat 15 so that it regulates, and if necessary blocks, the passage of the liquid into chamber 5 through inlet conduit 6.

In FIG. 3, an external adjustment device 17 particularly adapted to the first embodiment of the valve body 1 is represented.

The external regulation device 17 is made up of two magnets 18 and 19, for example made of samarium-cobalt, whose opposite faces have opposite polarities (N and S) and a magnetic mass greater than that of the mobile micro-magnets 12 and 13.

The magnets 18 and 19 are mounted on a common annular support 20, for example made of soft iron, and are diametrically opposed and separated by a distance substantially equal to or greater than the distance that separates the outer poles of the two mobile micro-magnets 12 and 13 when they are spikes

IS 2 139 161 T3

10a and 11a are inserted into cavities 4.

Figures 4 to 6 show a second embodiment of the valve body 1 'according to the present invention.

The valve body 1 'is made up of a box 3' and a disc-shaped upper cover 2 '.

The box 3 'has a central part 9' protruding from the inner wall 3b, which forms the central axis of the chamber 5.

Two pieces 10 'and 11' are movably mounted between the lateral branches 8a of the rotor 8, on either side of the central axis 9 '.

The movable parts 10 'and 11' respectively have a pin 10'a and 11'a which radially protrudes from the respective moving part towards the side wall 3a of the box 3 'and each house a micro-magnet 12' and 13 ', being the micro-magnets arranged so that they repel each other being of equal polarity (S o or N).

The locking means are constituted by said pins 10'a and 11'a capable of being inserted into cavities 4 'made in the internal periphery of the side wall 3a of chamber 5.

The chamber 5 also has abutment elements 21 projecting from the lower wall 3b of the box 3 'to limit the rotational displacement of the rotor 8.

Figure 7 represents an external regulation device 22 particularly adapted to the second embodiment of the valve according to the present invention.

The external regulation device 22 was constituted by an annular support 23 and by magnets 24 whose opposite faces are of the same polarity (N or S), the field lines of these magnets are channeled by soft iron pieces 24a, 24b devised of so that they make a magnetic ring formed by a circular succession of magnetized poles oriented radially towards the center of the support 23. These magnetized poles are also arranged diametrically two by two in such a way that two poles located on the same dioameter are of identical polarity and are separated by a distance substantially equal to or greater than that separating the outer poles of the two mobile micro-magnets 12 'and 13 'when the pins 10'a and 11'a are inserted in the cavities 4'.

It can be seen in figure 7 that two N poles are symmetrically surrounded on either side by four S poles.

Figure 8 shows a third embodiment of an external regulation device 25 according to the present invention.

The external regulation device 25 has an annular support 26 and electromagnetic means mounted circularly on said support 26.

The electromagnetic means are made up of magnetic bars 27 around which windings 28 are wound.

The bars 27 are arranged radially in the direction of receiving cavities 4 '.

The operation of these external regulation devices will now be described.

Figure 1 represents the valve body 1 in its locked position, the pins 10a and 11a being inserted into the cavities 4.

The micro-magnets lock the valve as a result of the magnetic attraction generated by the opposite polarities of micro-magnets 12 and 13.

The position of the rotor in the subcutaoneal valve is determined, in a general way, by means of a compass applied to the vertical of the valve. Its detection can also be carried out by a system that uses digital Hall effect probes associated with light-emitting diodes or by any other electromagnetic means.

Figure 3 represents the body of the valve 1 in its unlocked position, the pins 10a and 11a being both uncoupled from the cavities 4.

To unlock the valve, the external regulating device 17 illustrated in figure 3 is placed in the vertical of the valve body 1 so that the magnets 18 to 19 whose opposite faces have opposite polarities (N and S) are positioned symmetrically with respect to to the central axis 9 of chamber 5 on either side of micro-magnets 12 and 13.

Taking into account the difference in magnetic mass between the magnets of the external regulation device and the micro-magnets of the valve, the simple fact of bringing the N and S poles of the regulation device close to the opposite poles S and N of the micro-magnets, subject the two outer poles of the micro-magnets to a peripheral attraction greater than the central attraction of the two inner poles to each other. The result of this is a symmetrical and simultaneous separation of the two micro-magnets with their moving parts towards the periphery of the chamber, which unlocks the rotor and leaves it free to rotate. While the rotor is unlocked, it is possible to modify its position and, consequently, the operating pressure and the flow rate of the valve, by pivoting the adjustment device around the central axis of the valve chamber, which simultaneously drives the rotor. . To lock the rotor in a new determined position, it is sufficient to remove the regulating device, moving it vertically away from the plane of the valve. The two micro-magnets no longer being subjected to an external peripheral attraction, they then approach each other again under the effect of their mutual attraction, thus causing the movable parts to interlock.

This type of valve with movable micro-magnets cannot be misadjusted in the presence of a high-power external magnetic or electromagnetic field since the two movable micro-magnets cannot simultaneously disengage from their cavity in the presence of a unidirectional magnetic field.

To the extent that the two movable micro-magnets 12 and 13 are arranged on either side of the central axis of the valve, when one of the micro-magnets is attracted towards the periphery of the chamber, the other is repelled towards an interlocking cavity.

It is necessary to apply a particular regulating device such as the one illustrated in figure 3 to unlock the valve, that is, to separate the valve.

ES 2 139 161 T3 rar the micro-magnets symmetrically.

Of course, the power of the magnets must be greater than that of the micro-magnets so as to overcome the attractive force that exists between the micro-magnets.

Figure 4 represents the valve body 1 'in an interlocked position, the pins 10'a and 11'a being inserted in the cavities 4', due to the repellency generated by the arrangement of the micro-magnets 12 'and 13' whose faces are facing each other. they are of identical polarity (S).

In figure 7, an external regulation device 22 has been represented, capable of unlocking the valve 1 'illustrated in figure 4.

The unlocking is carried out here by placing the external adjustment device 22 in the vertical of the valve body 1 'so that the two magnetized poles 24a of identical polarity (N) are positioned symmetrically with respect to the axis 9' of the chamber 5 to one and the other side of the micro-magnets 12 'and 13'.

The micro-magnets 12 'and 13' are then disengaged from the cavities 4 'as a result of the repulsion generated by the identical polarity existing between the magnetized poles 24a and the micro-magnets 12' and 13 '.

The micro-magnets 12 'and 13' are then in unstable equilibrium and have a tendency to move by attraction towards the nearest magnetized pole 25b of opposite polarity (S), thus locking the rotor in a new position.

By rotating the external regulating device 22 around the central axis 9 ', a displacement of the rotor 8 from cavity to cavity is thus caused.

As in the type of magnetic attraction interlock valve described above with reference to Figure 1, this type of magnetic repellent interlock valve cannot be misadjusted in the presence of a high power external electromagnetic or magnetic field since the two movable micro-magnets cannot simultaneously disengage from their cavity in the presence of a unidirectional magnetic field. To the extent that the two movable micro-magnets 12 'and 13' are arranged on either side of the central axis of the valve, when one of the micro-magnets is attracted towards the center of the valve, the other is repelled towards a cavity of the valve. interlocking. It is necessary to apply a particular regulating device such as those illustrated in figure 7 and figure 8 to unlock the valve, that is, to bring the micro-magnets closer together symmetrically. Of course, the magnetic or electromagnetic field created by the regulating device must be more powerful than that between the two micro-magnets so as to overcome the repulsive force that keeps them apart.

Figure 8 shows an electromagnetic external regulation device 25 superimposed on the second embodiment of the valve according to the invention, namely the valve body 1 '.

This external electromagnetic regulating device 25 is not, however, limited to the valve body 1 ', but can also be applied to the first embodiment of the valve, namely the valve body 1.

This external electromagnetic regulation device 25 can be programmed in advance and is capable of sending sequences of coded electromagnetic pulses that correspond to the different locking positions of the rotor 8 in the chamber 5 through electromagnetic means constituted by the magnetic bars 27 and windings 28.

Although the invention has been described in connection with particular embodiments, it is clear that it is not limited to them in any way and that numerous variations and modifications can be made without departing from its framework.

Likewise, the valve according to the invention can be used in applications other than the treatment of hydrocephalus, and in particular, for example, for the realization of artificial urinary sphincters or drug delivery systems, such as morphine, insulin or drugs. anticancer.