FR2914560A1 - IMPLANTABLE SITE WITH TILTING SHUTTERS - Google Patents

Abstract

The invention relates to an implantable medical device (1) comprising an anti-piercing screen (30) characterized in that it comprises at least a first perforation-resistant shutter element (31) which has an access face (31A). and an opposing locking face (31B) which is rotatably mounted about a first tilting axis and which is arranged to tilt freely to an open position when a needle approaches it through its access face (31A), in order to allow said needle to cross the anti-piercing screen (30) in a first direction, and secondly to straighten in a closed position to form a stop at the against a needle which approaches it by its blocking face (31 B) in order to prevent said needle from crossing the screen (30) in a direction substantially opposite to the first direction. Implantable sites.

Description

IMPLANTABLE SITE WITH TILTING SHUTTERS

  The present invention relates to the general technical field of devices intended to be introduced under the skin of a human or animal patient so as to be subsequently stitched with a hollow needle, through the patient's skin, in order to Introduce and / or remove substances from the body of the patient while limiting the trauma associated with the reiteration of the bites. The present invention more particularly relates to an implantable medical device intended for the injection and / or sampling of a fluid in a human or animal body, said device comprising a chamber delimited by a wall which has at least a first puncture zone and a second puncture area located opposite each other and each designed to be pierced by a needle for injecting or puncturing said fluid in said chamber, said device comprising an anti-piercing screen designed to prevent a needle entering the chamber through the first puncture area from exiting the chamber by again piercing the wall through the second puncture area and vice versa. It is known to implant under the skin of a patient a medical device, called implantable site, intended to form a remote access point allowing the transfer of substances to or from the blood circulation network, the tissues of the patient. an organ, or an inflatable implant such as a balloon or a constriction ring. Generally, such an implantable site is in the form of a housing in which is formed a chamber delimited by a wall, said wall being at least partially designed to be pierced by a hollow needle B70404 / FR 2 for transfer, by injection or puncture, a fluid in said chamber.

  For this purpose, the wall usually has a puncture zone formed by a self-sealing membrane, or septum, made of an elastomeric material, so that the sealing of the site is preserved both when the needle passes through the wall and when it withdraws from it, the hole formed by the needle closing in effect automatically during the extraction of said needle by self-healing elastic phenomenon.

  Generally, the chamber communicates, through an outlet port, with a flexible catheter attached to the housing, so that the stitching area can be moved to an anatomical region more easily accessible than the area of destination or provenance of the transferred fluid.

  However, it has been found that, once implanted, the site is likely to turn on itself under the effect of a constraint or shock.

  In order to spare the patient a new surgical procedure intended to reposition the site, an implantable site has been devised comprising a chamber delimited by a cylindrical wall resistant to perforation and closed at each of its ends by a distinct circular septum. Thus, said site is in the form of a disk having two opposite puncture zones, one on its upper face and the other on its lower face, so that when one of said puncture zones rests on the subcutaneous tissue, the other puncture area is substantially opposite the skin of the patient. Advantageously, the chamber can therefore remain accessible in the event of a turnaround to 180 of the site on itself. B70404 / EN 3 However, this arrangement of the puncture areas exposes the site to a piercing through, with the consequence of a failure of the puncture or injection operation, or even a lesion of the subcutaneous tissues.

  That is why, in order to prevent the needle entering the chamber from again crossing the wall of the chamber substantially opposite its entry point, it has been proposed to dispose in the chamber a resistant screen to the perforation which obstructs the section of said chamber so as to lock the needle.

  Although it can be satisfactory especially in terms of comfort and stitching security, both for the patient and the practitioner, such a screen system can however have some significant disadvantages.

  In particular, the known screens may have relatively complex or bulky shapes, likely to increase the cost of manufacturing the site and / or the weight of the latter, to limit the useful volume of the chamber, or even to hinder the free flow of the fluid transferred. Then, these screens may have moving or deformable parts that, because of the repeated solicitations to which the needles submit, are likely, under certain circumstances, to hang or break resulting in irreversible dysfunction of the site.

  The objects assigned to the present invention therefore aim at overcoming the aforementioned drawbacks and at proposing a novel implantable medical device intended for the injection and / or sampling of fluid in a human or animal body whose implementation is particularly safe and reliable. B70404 / Ff? Another object assigned to the present invention is to provide a new implantable medical device that has excellent accessibility and facilitates the performance of stitching by the practitioner.

  Another object assigned to the present invention is to provide a new implantable medical device that is particularly simple, compact and lightweight design.

  Another object assigned to the invention is to propose a new implantable medical device whose implementation is particularly comfortable and atraumatic for the patient.

  Another object assigned to the invention is to propose a new implantable medical device whose manufacture is simple and inexpensive.

  Finally, another object assigned to the invention is to provide a new implantable medical device that is particularly strong and durable.

  The objects assigned to the invention are achieved by means of an implantable medical device intended for the injection and / or sampling of a fluid in a human or animal body, said device comprising a chamber delimited by a wall which has at least a first puncture zone and a second puncture zone located opposite each other and each designed to be pierced by a needle for injecting or puncturing said fluid in said chamber, said device comprising an anti-piercing screen adapted to prevent a needle entering the chamber through the first puncture area from exiting the chamber by again piercing the wall through the second puncture area and vice versa, said anti-piercing screen characterized in that it comprises at least a first puncture-resistant shutter member which has an access face and B70404 / FR a a opposite blocking ace, which is rotatably mounted around a first tilting axis (X1X1 ') and which is arranged to firstly freely switch to an open position, when a needle approaches it by its access side, in order to allow said needle to pass through the anti-penetrant screen in a first direction, and secondly to straighten in a closed position to form a stop against a needle which approach by its blocking face to prevent said needle from crossing the screen in a direction substantially opposite to the first direction.

  Other objects, features and advantages of the invention will appear in more detail on reading the description which follows, and with the aid of the accompanying drawings, provided for purely illustrative and non-limiting purposes, among which:

  - Figure 1 shows, in an exploded perspective view, a first embodiment of an implantable medical device according to the invention. FIG. 2 represents, in a broken-away perspective view, an assembled device according to the variant embodiment of FIG. 1. FIG. 3 illustrates, in a sectional view from above, a device according to the first variant of FIG. embodiment shown in Figures 1 and 2 in which a needle. FIG. 4 illustrates, in a perspective view, an embodiment of a shutter member according to that implemented in the first variant embodiment of the device shown in FIGS. 1 to 3.

  FIG. 5 represents, in an exploded perspective view, a second variant embodiment of an implantable medical device according to the invention. B70404 / FR - Figure 6 shows, in a longitudinal sectional view, a device according to the second embodiment of Figure 5, implanted under the skin of a patient.

  - Figure 7 shows, in a cutaway perspective view, an assembled device which corresponds to the second embodiment of Figures 5 and 6.

  - Figure 8 illustrates, in a sectional view from above, a device according to the embodiment of Figures 5 to 7 in which a needle.

  FIG. 9 illustrates, in a perspective view, an exemplary embodiment of a shutter element according to that implemented in the second embodiment variant of the device represented in FIGS. 5 to 8.

  The invention relates to an implantable medical device 1 for the injection and / or the removal of substances in a human or animal body.

  Such a device 1, also referred to as the implantable site, 15 is intended to be surgically implanted in the body of a patient, preferably under the skin of said patient, in order to constitute an access point for the introduction. or extracting fluids within the body of said patient.

  Said device 1 can be implemented and adapted for different uses.

  In particular, the device 1 according to the invention may be designed for the injection and / or removal of fluid in an organ or in the circulatory system, for example to allow the injection of drug substances. According to a particular variant of this application, said device 1 can be adapted to form a vein or artificial artery B70404 / FR that the practitioner can bite through the skin, in the manner of a natural vein, in order to inject a substance therapeutic or to draw blood.

  The device 1 according to the invention can also be adapted to feed implanted reservoirs associated for example with insulin or analgesic pumps.

  Said device 1 may finally be adapted for injecting and puncturing fluid into the inflatable or deflatable compartment of a surgical implant, such as an artificial sphincter, a balloon or a gastric ring intended to effect a constriction of the stomach to fight against obesity.

  In what follows, it will be more particularly considered that the device 1 constitutes a hypodermic device, that is to say that it is intended to be positioned just under the skin of the patient, as is illustrated in FIG. 6 , although said device can be implanted at other places in the body of the patient and in a deeper way without departing from the scope of the invention. According to the invention, the device 1 comprises a chamber 2 intended to receive the fluid injected or removed.

  Said chamber 2 is delimited by a wall 3 which has at least a first puncture zone 4 and a second puncture zone 5 which are situated facing each other and which are designed to be able to be pierced by a hollow needle 6 for injecting or puncturing the fluid in the chamber 2. B70404 / FR For this purpose, the wall 3 of the chamber 2 is preferably at least partially formed, at the level of said puncture zones 4, 5 by a self-sealing membrane 10 made of elastomer, for example silicone, preferably prestressing in compression.

  Said self-sealing membrane 10, or septum, is able to ensure the sealing of the device 1 both during the stitching by the needle 6 that after the withdrawal of said needle 6, the orifice generated by the piercing of said membrane 10 by means of the needle 6 automatically rebouching, by self-healing elastic, after extraction of the latter. By the expression situated opposite each other, it is indicated that the first and second puncture zones are, in the sense of the invention, arranged in such a way that it is geometrically possible to draw through the chamber 2 at least one direct path between an entry point M1 located in the first puncture zone 4 and an exit point located in the second puncture zone 5, that is to say it would be geometrically possible that, in the absence of anti-piercing screen as described below, a needle 6 entering the chamber 2 by the first puncture zone 4 passes through the device from side to side out of the chamber 2 by the second puncture zone 5. More specifically, considering that device 1 is implanted just under the skin 11 of the patient and that the wall 3 has a proximal wall portion 12 facing the skin 11, a distal wall portion 13 oriented to deeper tissues 14, and one or more lateral wall portions extending between the proximal wall portion and the distal wall portion, the first puncture zone 4 may be (by convention, as shown in Figure 6) located at the proximal wall portion 12, while the second puncture zone 5 may be 870404 / FR located at the distal wall portion 13 and / or one or both of the side wall portions. In a particularly preferred manner, the first and second puncture zones 4, 5 will be merged or at least contiguous to form a continuous puncture zone that is generally convex with respect to the outside of the device 1. In other words, the chamber 2, and more generally the device 1, will present the practitioner a projecting wall 3 bulging outwardly. Preferably, as illustrated in FIGS. 1 to 9, the chamber 2 has a geometry of revolution of axis (XX ').

  More generally, the implantable site 1 as a whole, and in particular the wall 3, preferably have an axis revolution geometry (XX ').

  In a particularly preferred manner, the chamber 2 will be in the form of a cylinder, the base of which may be substantially circular, or alternatively ovoid more or less flattened, of constant or variable radius along the axis of revolution (XX '). Furthermore, the chamber 2, and more generally the device 1, preferably has a substantially elongate shape that extends substantially along said axis of revolution (XX '). Thus, the device 1 may in particular adopt a substantially ellipsoid shape, olive or barrel, cylindrical right, cylindrical flattened, pear-shaped, etc.. It is remarkable that the base of the cylinder may also be in the form of a polygon, so that the chamber 2 is delimited by a polyhedron, without departing from the scope of the invention.

  In addition, the cumulative angular coverage of the first and second puncture zones 4, 5 around the axis of revolution (XX '), considered in a plane of projection normal to said axis of revolution, is advantageously sufficiently extended to allow stitching of the device 1 according to a plurality of approach directions (YY ') and MI entry points, so that the chamber 2 is easily accessible, even in case of reversal of the site on itself.

  More specifically, said cumulative angular coverage of the puncturing zones 4, 5 around said axis of revolution (XX ') is preferably greater than or equal to 90, more preferably greater than or equal to 180, and even more preferably, substantially equal to 360, the chamber 2 being in the latter case accessible in all directions of approach substantially normal to the axis of revolution (XX ').

  Advantageously, such a substantially rounded and rotationally invariant geometry simultaneously makes it possible to give the device a substantially atraumatic contour and to guarantee accessibility to the chamber 2 even in the event of overturning or tilting of the site 1 around its axis (XX ') .

  According to a preferred embodiment, the self-sealing membrane 10 is formed by one or more annular segments 10A, 10B stacked one on the other along the axis (XX ') and held in compression against one another by flanges 15, 16, 17 substantially perpendicular to the axis of revolution (XX '), the end flanges 15, 17 being preferably rigid and resistant to perforation.

  B70404 / FR Thus, each annular segment 10A, 10B continuously joins all or part of the first puncture zone 4 and all or part of the second puncture zone 5, so that said puncture zones 4, 5 extend over all around the device, 360 around the axis of revolution (XX ').

  In such an arrangement, the wall 3 preferably has, in directions normal to said axis (XX '), a substantially constant thickness.

  Moreover, the device 1 preferably comprises a tip 20 designed to put the chamber 2 in communication with a catheter 21, and a casing 22, with substantially atraumatic rounded contours, preferably made of a silicone-type biocompatible elastomer material in order to perfect the covering and the tightness of the device 1.

  In order to ensure the reliability of its operation, the device 1 according to the invention further comprises an anti-piercing screen 30 designed to prevent a needle 6 entering the chamber through the first puncture zone 4 from leaving the chamber 2 by piercing the wall again through the second puncture zone 5, and vice versa. According to an important characteristic of the invention, said anti-transppercernent screen 30 comprises at least a first perforating-resistant shutter member 31 which has an access face 31A and an opposite locking face 31B, which is rotatably mounted around a first tilting axis (X1X1 ') and which is arranged on the one hand to freely switch to an open position, also called a passing position, when a needle 6 approaches it via its access face 31A, to allow said needle 6 to cross the anti-piercing screen 30 in a first direction F1, and secondly to straighten in a closed position, also called blocking position, to form an abutment against a needle 6 which approaches it by its locking face 31B so

  B70404 / FR to prevent said needle 6 from crossing the screen 30 in a direction substantially opposite to the first direction F1.

  By freely tilting, it is indicated that the first shutter element 31 is designed to move spontaneously when a needle 6 enters the chamber 2 by the first puncture zone 4, so that said first shutter element 31 does not constitute an obstacle. penetration and progression of the needle to the interior of the chamber.

  Within the meaning of the invention, when said first shutter element 31 is in its closed position and no needle is already stitched in the chamber, said first shutter member element is, in normal operation, never locked to the direction of rotation corresponding to its opening movement, that is to say to its displacement from its closed position to its open position. Thus, the opening movement is caused automatically by the depression of the needle 6 in the site via the first puncture zone 4 and does not require any particular intervention of the practitioner.

  More specifically, the first shutter member 31 is preferably arranged to be driven in its opening movement by the mechanical recovery of a momentum provided by the needle 6 when said needle sinks into the chamber 2 from the first puncture zone 4. Preferably, this transfer of momentum is effected by direct contact of the bevel of said needle 6 against the access face 31A of the first shutter member.

  Advantageously, the use of a rotational movement minimizes the driving energy to be provided to drive the first shutter member 31, and in particular reduces the risk of jamming and unexpected blocking of the latter.

  It is conceivable to combine the first tilting shutter member with any other stop means, such as a puncture-resistant panel or lattice stretched deeper across the chamber 2 and able to intercept the needle. 6 after it has passed the first shutter member 31 in the first direction FI.

  Preferably, the anti-piercing screen, however, comprises at least one second perforation-resistant shutter member 32 which has an access face 32A and an opposite locking face 32B, which is rotatably mounted about a second axis tilting (X2X2 ') and which is arranged to firstly freely switch to an open position, when a needle 6 approaches it by its access face 32A, to allow said needle 6 to cross the anti-puncture screen 30 in a second direction F2, and secondly straighten in a closed position to form a stop against a needle 6 which approaches it by its locking face 32B in order to prevent said needle 6 from crossing the screen 30 in a direction substantially opposite to the second direction F2.

  Within the meaning of the invention, the second shutter element 32 is preferably distinct from the first and borrows, to move from its closed position to its open position, and vice versa, a second path distinct from that followed by the first shutter member 31.

  Preferably, when they are each in the closed position, the first and second shutter members 31, 32 have their respective access faces 31A, 32A opposite the first puncture zone 4 and the second puncture zone 5. respectively, while their respective blocking faces 31B, 32B are located substantially vis-à-vis one another. B70404 / FR Thus, the first crossing direction F1 and the second crossing direction F2 are preferably substantially opposite, the shutter elements cooperating mutually so that each shutter member ensures the locking of the needles that the other shutter member passes. In other words, by analogy with a hydraulic circuit, the shutter elements form a kind of unidirectional valves mounted in opposition. By substantially opposite direction of crossing, it is indicated that there is at least one line joining a point of the first puncture zone 4 to a point of the second puncture zone 5 on which the respective projections of the vectors representing the first direction of crossing. FI and the second crossing direction F2 are oriented, i.e., pointing, in opposite directions.

  Advantageously, the first shutter element 31 is designed so as to deviate to give way to a needle 6 penetrating into the chamber 2 by the first puncture zone, so that it releases access to the chamber 2 substantially at the point of entry M1 of said needle 6, while the second shutter member, possibly in cooperation with the first shutter member 31, condemns the exits of the chamber at the second puncture zone situated opposite from the point of entry MI. Thus, the needle 6 is free to enter the chamber 2 but is locked in an abutment position before being able to reach, and a fortiori before crossing, the wall 3 opposite its point of entry.

  Within the meaning of the invention, the stop position of the needle 6 constitutes a stable stopping position in which the progression of said needle 6 is blocked in the direction of penetration.

  B70404 / FR Of course, the number and geometry of the shutter elements implemented within the anti-piercing screen 30 according to the invention are in no way limited.

  Likewise, the number and shape of the puncture zones, as well as their respective association with one and / or the other of the shutter elements, is in no way limited to a particular variant embodiment. The particular configurations and references used in this document are for convenience of description.

  More particularly, as illustrated in FIGS. 1 to 3 and 5 to 8, the anti-piercing screen preferably comprises a third perforation-resistant shutter member 33 which has an access face 33A and a blocking face. opposed 33B, which is rotatably mounted about a third axis of tilting (X3X3 ') and which is arranged on the one hand to freely switch to an open position, when a needle 6 approaches it by its side 33A, to allow said needle 6 to cross the anti-piercing screen 30 in a third direction F3, and secondly to straighten in a closed position to form a stop against a needle 6 which approaches it by its blocking face 33B to prevent said needle 6 from crossing the screen 30 in a direction substantially opposite to the third direction F3.

  Preferably, the first, the second and the third shutter element 31, 32, 33 are distributed equidistantly in a not substantially equal to 120 offset pitch around the axis of revolution (XX ') of the device 1.

  Of course, each shutter element or each pair of shutter elements is likely to have an arrangement and a behavior B70404'FR similar to those described above with reference to the first and the second shutter element 31, 32.

  Preferably, the first, the second and / or the third tilting axis (X1X1 '), (X2X2'), (X3X3 ') are mounted fixed, relative to each other on the one hand, and with respect to the room 2 and more generally compared to site 1 on the other hand. By the term mounted fixed, it is indicated that said tilting axes, apart from their possible rotational movement on themselves, are not likely to change their position, relative to each other on the one hand , and / or with respect to the chamber 2 or the wall 3 on the other hand. In addition, said tilting axes preferably extend substantially parallel to one another, and particularly preferably substantially parallel to the axis of revolution (XX ').

  Preferably, as shown in FIGS. 4 and 9, the first shutter element 31 is formed by a first shutter 41, 141 which has two main extension faces forming an extrados 41E, 141E and a lower surface 411, 1411. Said extrados 41E, 141E and said underside 411,1411. connect a so-called captive end 41C, 141C, connected to the first tilting axis (X1X1 '), at a free end 41L, 141L.

  Within the meaning of the invention, and as shown in FIGS. 2 or 7, the upper surface 41E, 141E is normally intended to be oriented, at least when the first flap 41, 141 is in a locking position, towards outside of the chamber 2, while said intrados 411, 1411 is oriented towards the inside of the chamber. Thus the extrados 41E, 141E forms the access face 31A and the lower surface 411, 1411. the locking face 31B. B70404 / FR Similarly, the second shutter element 32 and / or the third shutter element 33 are preferably respectively formed by a second flap 42, 142 and a third flap 43, 143 which each have an extrados 42E, 142E, 43E, 143E and a lower surface 421, 1421, 431, 1431 connecting a captive end 42C, 142C, 43C, 143C, connected to the first and second tilt axis respectively, at a free end 42L, 142L, 43L, 143L.

  In a particularly preferred manner, the first, second and third flaps 41, 42, 43 (respectively 141, 142, 143) are substantially identical in their shapes and their dimensions.

  Advantageously, this structural identity makes it possible to limit the number of models of parts necessary for the manufacture of the site and to simplify the assembly operations insofar as the shutters are interchangeable.

  Preferably, the respective tilting axes (X1X1 '), (X2X2'), (X3X3 ') of the flaps are located in the chamber 2 close to the wall 3, whereas the first, second and / or third flaps, and more specifically their respective extrados, are substantially contiguous to the wall 3 when said flaps are in the closed position, as is illustrated in Figures 2 and 7.

  Thus, said flaps are pivotable and their free end to move away from the wall 3 by sinking into the chamber as they move from their locking position (closing) to their passing position (opening).

  The blocking position of the shutter elements will preferably correspond substantially to a so-called upward or rectified closed position of the corresponding flaps, in which said flaps substantially cover an extent of the wall 3 so as to form protective panels 870404 / FRR preventing a needle within the chamber from emerging by piercing said wall 3 from the inside to the outside.

  Conversely, the passing position corresponds to a so-called lowered or tilted opening position, in which the free end of the flap is pushed into the depth of the chamber, the extrados being detached and away from the wall 3, so that to clear a passage window sufficient to allow the needle 6 to enter the chamber 2 to a functional depth.

  Within the meaning of the invention, and by analogy with the operation of a shutter placed on a building window, it can therefore be considered that the transition from the blocking position to the passing position constitutes an opening movement, while at conversely, the passage from the passing position to the blocking position constitutes a closing movement.

  Moreover, the extrados 41E, 42E, 43E, (respectively 141E, 142E, 143E) flaps preferably have a convex shape vis-à-vis the outside of the chamber 2. Such a geometry advantageously allows the bevel of the needle 6, regardless of the orientation (W ') taken by said needle 6, to easily slide along the ramp formed by the upper surface when the flap tilts inwardly of the chamber.

  More preferably, the profile of the extrados form substantially an arc of a circle, of radius equal to or slightly less than the radius of the chamber 2.

  Although the surface of the extrados may have a ribbed or rough appearance, in particular to allow the practitioner to feel the contact of the needle with the flap, which informs him of the penetration into the chamber 2, the surface said extrados will preferably be smooth. In addition, it may be coated with a non-stick coating facilitating the sliding of the needle.

  It is remarkable that, in the preferred embodiments illustrated in FIGS. 1 to 3 and 5 to 8, each flap is arranged cantilevered with respect to its tilting axis, so that it offers a lever arm that spontaneously converts the needle penetration thrust, even low, into a relatively large engine torque that rotates said flap.

  Furthermore, the intrados of the flaps preferably have a concave shape vis-à-vis the interior of the chamber 2. Such a configuration allows on the one hand to better trap the needles, blocking them stably at the bottom bowls or wells thus formed, on the other hand to preserve the space required to move the flaps, and finally to optimize the useful volume of the chamber 2 by maximizing the available space circumscribed by said flaps.

  According to a preferred embodiment, when the first flap 41, 141 is in the locking position, as shown in Figures 2 and 7, it bears against the second flap 42, 142.

  More specifically, a portion of the extrados 41E, 141E of the first flap 41, 141 is preferably abutted against an intrados portion 421, 1421 of the second flap 42, 142.

  In a particularly preferred manner, it is the free end 41L, 141L of the first flap 41, 141 which is able to come into abutment against the captive end 42C, 142C of the second flap 42, 142. Thus, 25 l is obtained. stopping effect sought while optimizing the ratio between the useful puncture surface area and the size of the flaps (and / or the device). - B70404 / FR Indeed, the second flap 42, 142, thanks to the attachment point that constitutes its second tilting axis (X2X2 '), advantageously forms a stop which limits the movement of the first flap 41, 141 in the direction of its closing movement.

  Said first flap 41, 141 is therefore retained, when it is in the locking position, both by its own tilting axis (X1X1 ') and by that of the second flap 42, 142, against a possible thrust stress exerted on its intrados 411, 1411, in particular when a needle 6 hits said intrados 411, 1411.

  More generally, as illustrated in particular in FIGS. 2 and 7, the first, second and third flaps 41, 42, 43 (respectively 141, 142, 143) are preferably contiguous so that the portion extrados of the free end of each flap come overlap, in blocking position, the intrados portion of the captive end of the adjacent flap.

  Advantageously, this partial mutual overlap guarantees the strength and the holding of the anti-piercing screen 30, by providing any shutter in the locking position with two bearing points (its own tilting axis and that of the adjacent flap) which allow to resist the thrust exerted, directly or indirectly, the needle 6 on its underside, to immobilize said needle in the direction of its penetration into the chamber 2.

  For this purpose, the tilting axes of the first, second and third flaps are preferably distributed equidistantly, in an angular offset pitch substantially equal to 120, about the axis of revolution (.X ') of the device 1 , as shown in particular in FIGS. 2, 3, 7 and 8.

  B70404 / FR It is remarkable that such an arrangement allows the shutters to upholster the entire wall 3, while permitting the penetration of a needle from the outside almost on the whole of said wall 3. The usable surface area of the site 1 in accordance with the invention can therefore advantageously be substantially equal to the outer surface of its self-sealing membrane 10. In other words, the anti-piercing screen according to the invention is preferably divisible, that is, that is to say divided into a plurality of shutter elements which form, when in the closed position, a substantially continuous assembly, which is capable of being split, or interrupted, during the penetration of the needle.

  In a particularly preferred manner, one and / or the other of the shutter elements 31, 32, 33 are prestressed towards their respective closed position by an elastic return means 50. More specifically, said elastic return means 50 is preferably designed to tend to return said shutter elements substantially from their open position to, and preferably up to, their closed position. Thus, the closed position will preferably correspond to a stable position, that the flap adopts when the site is at rest, that is to say when said flap is not biased by a needle in its opening direction. .

  According to a first embodiment corresponding to FIGS. 1 to 4, said elastic return means 50 is formed by a torsion spring 51 (or preferentially by a pair of torsion spring) comprising at least two arms, one of which bears on the wall 3 and the other abuts on the locking face 31 B, 32B, 33B of the shutter member considered. B70404 / FR According to this first embodiment, the flaps 41, 42, 43 may be in the form illustrated in FIG. 4.

  In particular, said flaps 41, 42, 43 are preferably entirely rigid and may be made in one piece in a rigid biocompatible material, either metallic, of titanium type, or polymeric, of polyoxymethylene type (POM ), poly-ether-ether-ketone (PEEK), poly-sulfone (PSU) or polyolefins (PP, PE).

  Said flaps 41, 42, 43 are preferably rotatably mounted around their respective tilt axis.

  To this end, said flaps may have bent tongues 60, intended to be slid pivotally sliding on the inserted rods 61, 62, 63 integral with the end flanges, so as to form hinges.

  It is remarkable that this first embodiment allows the implementation of particularly thin flaps, which lighten the site 1 and 15 to gain compactness.

  As an alternative embodiment not shown, the first, the second and / or the third tilting axis (X1X1 '), (X2X2'), (X3X3 ') are integral with the first, the second and the third flaps 41, 42, 43 respectively, each shutter member 31, 32, 33 can thus be monolithic.

  More specifically, each tilting axis may be embodied by stepped cylindrical protuberances which project at the base and at the top of the captive end 41C, 42C, 43C, said protuberances forming spans intended to be journalled in sliding bearings of shape. In a second embodiment corresponding to FIGS. 5 to 9, the mobility of the shutter member 31, 32 is formed by means of housings formed in one and / or the other of the end plates 15, 17. , 33 is obtained not by a rotary connection in pivot connection, but by a deformable mechanism.

  More precisely, the elastic return means 50 is then preferably formed by a deformable elastic hinge 52.

  In a particularly preferred manner, said deformable elastic hinge 52 is integral with the shutter element considered, and more specifically with the flap 141, 142, 143 corresponding. In other words, the intrinsic elasticity of the material constituting a one-piece flap 141, 142, 143 can advantageously be exploited to make the latter work in flexion.

  Of course, the material constituting the deformable elastic hinge 52 and the shutter member will be chosen so as to have, on the one hand, an elasticity adapted to its hinge function and, on the other hand, a sufficient rigidity to be able to withstand the perforation by the needle 6, especially when the flap is biased at its intrados.

  By way of example, it is possible to use a superelastic metallic material, such as an alloy based on nickel and titanium, or a semi-rigid polymer material, such as POM or polyolefins.

  In addition, as illustrated in FIGS. 8 and 9, the flaps 141, 142, 143 may have a longitudinal groove 53 which will materialize the hinge by reducing their thickness in order to create a zone of preferential deformation in flexion.

  According to an alternative embodiment not shown, one or other of the hinges 52 are bistable. By bistable, it is indicated that the hinge B70404 / FR considered is arranged to be able to occupy alternately a first equilibrium position and a second equilibrium position, said equilibrium positions being separated by a plurality of unstable intermediate positions in which the hinge tends to be resiliently biased to either its first equilibrium position or to its second equilibrium position. In other words, the hinges 52 can form flip-flops, whose tilting threshold is preferably chosen substantially midway between their first equilibrium position, which corresponds to the closed position of the associated shutter element, and their second equilibrium position corresponding to the opening position of said shutter member.

  Thus, when a needle pushes a shutter into the chamber and said shutter reaches an angular position corresponding to the tilting threshold, the transition from the closed position to the open position of said shutter continues spontaneously under the impulse of the hinge 52 itself, and vice versa during the closing movement.

  Furthermore, the flaps 141, 142, 143 are preferably provided with fixing lugs 70 at the base and at the top of their captive end, said lugs being intended to be inserted into housings of conjugated form formed in the end flanges 15, 17, so as to maintain the axes of said flaps in a substantially fixed position.

  In addition, the flaps 141, 142, 143 are preferably provided with retaining beads 71 extending opposite the free end with respect to the tilting axis and arranged to bear against the wall 3.

  Said retention heels 71 prevent the integral tilting of the entire flap, and thus form a portion locked in rotation which defines the return position corresponding to the state of rest of the flexible portion of said flap.

  B70404 / FR 25 In a particularly advantageous manner, the second embodiment according to the invention minimizes the number of component parts, and in particular the number of moving parts, of the site 1 which thus gains in simplicity of design, in lightness, in comfort of use and longevity.

  Furthermore, the tilting axes linking the end flanges 15, 17 may advantageously constitute reinforcing and holding elements in the shape of the structure of the site 1.

  By contributing to improving the mechanical strength of the site, and more specifically by forming a kind of rigid reinforcement capable of supporting the membrane 10, said tilting axes make it possible, in particular, to refine said membrane 10. In fact, it is possible to confer said membrane 10 has a thickness that is just necessary and sufficient for its self-sealing function, no excess thickness then being absolutely necessary to stiffen the wall 3 in order to avoid crushing or distension of the chamber 2.

  The structure of the site 1 can thus be significantly reduced.

  The operation of a site 1 according to the invention will now be briefly described.

  Initially, the site is in a configuration corresponding to that of Figure 2 or Figure 7, the three flaps being in the raised position, substantially pressed against the wall 3.

  A needle 6 passes through the wall 3 at the first puncture zone 4, by perforating the membrane 10, in a direction of penetration (YY ') and is at the edge of the chamber 2 at a point of entry M1 . B70404 / FR As soon as in the chamber 2, the bevel of said needle 6 hits the extrados 41E of the first shutter 41, 141, that is to say the access face 31A of the first shutter element.

  The penetration force exerted by the practitioner on the needle 6 is transmitted by contact to the first flap 41, 141 and creates a motor torque, represented by the arrow in FIGS. 3 and 8. Said driving torque drives said first flap 41, which then initiates a rotation, here in the clockwise direction, around its tilting axis (XIX1 ').

  According to whether said first flap is hinged by means of a smooth pivot connection (FIG. 3) or a flexible hinge (FIG. 8), its opening movement is effected either by rotation in one piece or by deflection of a movable portion of the flap relative to a fixed portion thereof.

  The needle 6 thus pushes the first flap 41 of the wall 3, in particular detaching its free end 41L from the captive end 42C of the second flap 42 on which it rested.

  The needle 6 continues its progression by sinking into the chamber 2 and progressively spreading the first flap 41 of its way, a little like the way you push the door of a door to enter a room.

  In doing so, the flap thus moved strips the elastic return means 50.

  According to the direction of penetration (YY ') of the needle, the movement of said needle 6 tends to be accompanied by a relative sliding of its bevel along the slope formed by the curved surface of the extrados 41E, 141E .

  After entering the chamber through the screen at the level of the first flap, the needle 6 can, depending on its orientation, be stopped either B70404 / fR directly by the extrados 41E, 141E of the first flap 41, 141 itself if the free end of the latter abuts against the intrados of the third flap 43, 143, either by the lower surface 421, 1421 of the second flap 42, or by the underside 431, 1431 of the third flap, such that this is shown in Figures 3 and 8.

  When he feels the resistance to advancement against the antitranspercement screen 30, the practitioner infers that he has reached the functional depth and then actuates the plunger of the syringe to proceed to the injection or puncture.

  The practitioner then extracts the needle 6 from the chamber 2 by exerting traction that pulls it to the site 1 along an extraction path substantially opposite to its penetration path.

  During removal of the needle 6, the driving energy temporarily stored by the elastic return means 50 is restored by the latter to provide a return torque which drives the first flap 41, 141 to bring it back to its position. initial closure. Of course, the site 1 adopts a similar behavior that the needle approaches at the first, second or third shutter, the screen can be opened by the needle from all directions substantially normal to the axis of revolution () OX ').

  Thus, advantageously, regardless of its point of entry on the self-sealing membrane 10 and its direction of penetration, the needle 6 will be able to remove itself the proximal shutter element in order to penetrate the heart. of the chamber 2, in the protected space circumscribed by the anti-piercing screen 30, before its progression is firmly and surely stopped by the distal shutter element (s). The anti-B70404 / FR piercing screen in accordance with the invention therefore advantageously constitutes a kind of multidirectional valve permeable to the proximal penetration but impermeable to distal perforation, whatever the direction in which the needle approaches the site.

  Thus, the device 1 according to the invention advantageously makes it possible to produce an implantable site that is noticeable substantially from all the directions of space, and whose implementation is particularly intuitive and safe.

  Advantageously, such a site minimizes the intervention time of the practitioner, avoids the unnecessary reiterations of stitching gestures inherent to the poor positioning of the needle relative to the site and thereby improves the comfort of use of said device both for the patient only for the practitioner.

  In addition, particularly advantageously, the large free space between the flaps makes it possible, on the one hand, to penetrate the needle into the chamber to a sufficient functional depth, and, on the other hand, to allow free circulation of the fluid in the chamber. within the chamber, which improves the reliability and efficiency of the device. In addition, the implementation of the anti-puncture screen according to the invention requires little needles used, thus minimizing the risk of septum tears caused by veiled needles or damaged bevels.

  Finally, the simplicity, lightness and compactness of the anti-piercing screen in accordance with the invention advantageously make it possible to produce an implantable site that is both compact and inexpensive, whose mechanical strength and longevity are particularly high. B704041FR

Claims (5)

  1 - Implantable medical device (1) intended for the injection and / or sampling of a fluid in a human or animal body, said device (1) comprising a chamber (2) delimited by a wall (3) which presents the minus a first puncture area (4) and a second puncture area (5) facing each other and each designed to be pierced by a needle (6) for injection or puncturing said fluid in said chamber (2), said device (1) comprising an anti-piercing screen (30) disposed inside the chamber (2) and adapted to prevent a needle (6) entering the chamber (2) ) through the first puncture zone (4) out of the chamber (2) by again piercing the wall (3) through the second puncture zone (5) and vice versa, said antitranspercement screen (30) being characterized by it comprises at least a first shutter element (31) resistant to the rforation which has an access face (31A) and an opposing locking face (31B), which is rotatably mounted about a first tilting axis (XIXi ') and which is arranged to freely tilt freely towards an open position, when a needle (6) approaches it by its access face (31A), in order to allow said needle (6) to cross the antitranspercement screen (30) in a forward direction ( FI), and on the other hand straighten in a closed position to form a stop against a needle (6) which approaches it by its blocking face (31B) in order to prevent said needle (6) ) to traverse the screen (30) in a direction substantially opposite to the first direction (FI).   2 - Device according to claim 1 characterized in that the antitranspercement screen (30) comprises at least one second perforating-resistant shutter member (32) which has a B70404 / FR access face (32A) and a locking face ( 32B) which is rotatably mounted about a second tilting axis (X2X2 ') and which is arranged on the one hand to swing freely to an open position, when a needle (6) approaches it by its access face (32A), to allow said needle (6) to cross the antitranspercement screen (30) in a second direction (F2), and secondly to straighten in a closed position to form an abutment against a needle (6) which engages with its locking face (32B) to prevent said needle (6) from passing through the screen (30) in a direction substantially opposite to the second sense (F2).   3 - Device according to claim 2 characterized in that the first and second tilting axis (X1X1 '), (X2X2') are fixed mounted.   4 - Device according to claim 2 or 3 characterized in that the first and second tilting axis (XIX1 '), (X2X2') extend substantially parallel to each other. - Device according to one of claims 2 to 4 characterized in that, when in the closed position, the first and second shutter elements (31, 32) have their respective access faces (31A, 32A) in view of the first puncture zone (4) and the second puncture zone (5) respectively, while their respective blocking faces (31B, 32B) are located substantially opposite one of the other. 6 - Device according to one of the preceding claims characterized in that the first and / or the second shutter member (31, 32) 25 respectively, is formed by a first flap (41, 141), respectively a second flap (42). , 142), whose extrados (41E, 141E, 42E, 142E) forms the access face (31A, 32A) and the underside (411, 1411, 421, B70404 / FR1421) forms the locking face (31B , 32B), said extrados and intrados connecting a captive end (41C, 141C, 42C, 142C) rotatably mounted around the first tilting axis (X1X1 '), respectively of the second tilting axis (X2X2'), at a free end (41L, 141L, 42L, 142L). 7 - Device according to claim 6 characterized in that the extrados (41E, 141E, 42E, 142E) have a convex shape vis-à-vis the outside of the chamber.  8 -Dispositif according to claim 6 or 7 characterized in that the intrados (411, 1411, 421, 1421) have a concave shape vis-à-vis the interior of the chamber. 9 - Device according to one of claims 6 to 8 characterized in that the first and / or second flaps (41, 141, 42, 142) are substantially contiguous to the wall (3) when in the closed position . 10 -Dispositif according to one of claims 5 to 9 characterized in that, when the first flap (41, 141) is in the closed position, its free end (41L, 141L) bears against the captive end (42C, 142C) of the second flap (42, 142). 11 - Device according to one of the preceding claims characterized in that the first and the second puncture zone (4,   5) are combined to form a generally continuous convex puncture zone vis-à-vis the outside of the device. 12 - Device according to one of the preceding claims characterized in that the chamber (2) substantially has a geometry of axis revolution (XX ') and in that the angular coverage of the puncture areas B70404 / FR around said axis of revolution is greater than or equal to 900, preferably greater than or equal to 180, and particularly preferably substantially equal to 360. 13 -Dispositif according to claims 2 and 12 characterized in that it comprises a third perforating-resistant shutter member (33) which has an access face (33A) and an opposing locking face (33B), which is mounted mobile rotation about a third axis of tilting (X3X3 ') and which is arranged on the one hand to freely switch to an open position, when a needle (6) approaches it by its access face ( 33A), in order to allow said needle (6) to cross the antitranspercement screen (30) in a third direction (F3), and secondly to straighten in a closed position to form an abutment against a needle (6) which approaches it by its locking face (33B) to prevent said needle (6) from crossing the screen (30) in a direction substantially opposite to the third direction (F3), and in that that the first, second and third shutter elements (31, 32, 33) are equidistantly distributed at 120 around the ax e revolution (XX ') of the device, their respective tilt axes being substantially parallel to said axis of revolution (XX'). 14 -Dispositif according to claims 5 and 14 characterized in that the first, second and third shutter elements (31, 32, 33) are formed respectively by a first, second and third component (41, 42, 43, respectively 141, 142 , 143), substantially identical in their shapes and dimensions, and contiguous so that the extrados portion of the free end of each of said flaps comes to overlap, in the closed position, the intrados portion of the end captive of the neighboring shutter. B70404 / FR15 Device according to one of the preceding claims characterized in that one and / or the other of the shutter elements (31, 32, 33) are preloaded to their respective closed position by an elastic return means (50 ). 16 -Dispositif according to claim 15 characterized in that the elastic return means (50) is formed by a deformable elastic hinge (52). 17 -Dispositif according to claim 16 characterized in that the deformable elastic hinge is integral with the shutter member considered. 18 -Dispositif according to claim 16 or 17 characterized in that the deformable elastic hinge (52) and / or the shutter member (31, 32, 33) are made of a super-elastic metal material, such as an alloy to Nickel and Titanium base, or in a semi-rigid polymer material, such as POM or polyolefins. 19 -Dispositif according to one of claims 16 to 18 characterized in that the hinge (52) is bistable. - Device according to claim 15 characterized in that elastic return means (50) is formed by a torsion spring (51) 20 comprising at least two arms, one of which bears on the wall (3) and the other comes resting on the locking face (31B, 32B, 33B) of the shutter element in question. 21 -Dispositif according to claim 20 characterized in that the obturator element considered is rigid, and preferably made of a 870404 / FRmocompatible rigid material, either metal, titanium type, or polymer type POM, PEEK, PSU or polyolefins . 870404 / EN '