FR2914561A1 - IMPLANTABLE SITE WITH CAM SCREEN - Google Patents

Abstract

The invention relates to an implantable medical device (1) comprising an anti-piercing screen characterized in that it comprises: - at least one first shutter element and a second shutter element, each being resistant to perforation and mounted movably between a position passerby in which it authorizes the passage of a needle (6) through the anti-piercing screen and a blocking position, in which it opposes the crossing of said anti-piercing screen by the needle (6), and coupling means (34) functionally combining the first and the second shutter element so that the passage of the first shutter member from its blocking position to its passing position causes the second shutter member to pass from its passing position to its blocking position; Implantable sites.

Description

1 IMPLANTABLE SITE WITH CAM SCREEN

  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.

  It is known to implant under the skin of a patient a medical device, called an 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 87040: i / FR intended to 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. 87040: 5 / EN However, this provision of the puncture areas exposes the site to a piercing through, resulting in a failure of the puncture or injection operation, or even a lesion of 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 may be satisfactory particularly in terms of comfort and stitching security, both for the patient and the practitioner, such a screen system may 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. B70405 / FR Another object of the present invention is to provide a new implantable medical device that has excellent accessibility and facilitates the performance of the stitching gesture by the practitioner.

  Another object of the present invention is to provide a novel implantable medical device which is particularly simple in design, compact and lightweight.

  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 of the invention is to provide a novel implantable medical device which is simple and inexpensive to manufacture.

  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 attained 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 20 for injecting or puncturing said fluid into said chamber, said device comprising an anti-piercing screen adapted to prevent a needle penetrating into the chamber through the first puncture area from exiting the chamber by again piercing the wall through the second puncture area, said anti-piercing screen being characterized in that it comprises: B70405 / Ff? at least a first shutter member and a second shutter member, each of said first and second shutter members being puncture resistant and movably mounted between a passing position in which it allows a needle to pass through the anti-piercing screen and a blocking position, in which it opposes the crossing of said anti-piercing screen by the needle, and a coupling means functionally combining the first and the second shutter element so that the passage of the first shutter member of its blocking position at its passing position causes the second shutter member to pass from its passing position to its blocking position.

  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, an alternative embodiment of an implantable medical device according to the invention. - Figure 2 shows, in a longitudinal sectional view, the embodiment of Figure 1 implanted under the skin of a patient. FIG. 3 illustrates, in a perspective view, an alternative embodiment of a shutter element according to that used in the variant embodiment of FIGS. 1 and 2.

  - Figures 4 to 11 illustrate, in cross-sectional views, the operation of the alternative embodiment of a medical device according to the invention shown in Figures 1 and 2. B70405 / FR The invention relates to a medical device implantable 1 for injection and / or removal of substances in a human or animal body.

  Such a device 1, also designated by the name implantable site, 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 the 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 an artificial vein or artery that the practitioner can prick through the skin, in the manner of a natural vein, in order to inject a therapeutic substance or take blood. The device 1 according to the invention can also be adapted to supply 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 achieve a constriction of the stomach to fight against obesity. B70405 / FR In the following, 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, although said device can be implanted at other places in the patient's body 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 located facing each other and which are designed to be pierced by a hollow needle 6 for injecting or puncturing the fluid in the chamber 2.

  For this purpose, the wall 3 of the chamber 2 is preferably at least partially formed, at said puncturing 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 B70405 / FR located in the first puncture zone 4 and an exit point located in the second puncture zone 5, that is to say that It would be geometrically possible for, in the absence of an anti-piercing screen as described below, a needle 6 penetrating into the chamber 2 through the first puncture zone 4 to pass through the device from one side to the other. chamber 2 by the second puncture zone 5.

  More specifically, considering that the 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 towards the deeper tissues 14, and one or more sidewall portions extending between the proximal wall portion and the distal wall portion, the first puncture zone 4 may be (by convention) located at the proximal wall portion, while the second Puncture area 5 may be located at the distal wall section and / or one or both of the side wall sections.

  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 shown in FIGS. 1 to 11, the chamber 2 has a geometry of revolution of axis (XX ').

  More generally, the implantable site as a whole, and in particular the wall 3, preferably has a geometry of revolution axis (XX '). B70405 / FR Particularly preferably, the chamber 2 will be in the form of a cylinder, whose base may be substantially circular, or 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, straight cylindrical, 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 extended enough to allow stitching of the device 1 according to a plurality of approach directions (YY '), (Y2Y2') and entry points M1, M2, so that the chamber 2 is easily accessible, even if the site is turned over on itself. even.

  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 '). B70405 / FR Advantageously, such a substantially rounded and invariant rotation 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 a reversal.

  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.

  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 all the way around. of 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 again piercing the wall through the second puncture zone 5. B7040: VFR According to an important characteristic of the invention, said antitranspercement screen 30 comprises: at least one first shutter element 31 and a second shutter element 32, each of said first and second shutter members 31, 32 being puncture resistant and movably mounted between a passing position in which it allows the passage of a needle 6 through the anti-piercing screen 30 and a blocking position in which it opposes at the crossing of said antitranspercement screen 30 by the needle 6, and - a coupling means 34 functionally combining the first and the second element t shutter 31, 32 so that the passage of the first shutter member 31 from its blocking position to its passing position causes the passage of the second shutter member 32 from its passing position to its blocking position.

  By functionally associated partner, it is indicated that the coupling means 34 establishes a dependency link between the operation, and more precisely the displacement, of the first shutter element 31 and the operation, and more precisely the displacement, of the second shutter element 32. In particular, FIG. In other words, the coupling means 34 advantageously makes it possible to form a functional connection between a first and a second shutter element that are distinct.

  Preferably, said coupling means 34 comprises for this purpose a return mechanism designed to transfer motive power, and more precisely a momentum, from the first shutter member 31 to the second shutter member 32 when the first shutter member moves. from its blocking position to its passing position. B7040: 5 / FR Although it is conceivable to perform a contactless coupling of magnetic type, said return mechanism is preferably of a mechanical nature and can for example implement a gear system, a linkage, a set of cams, a hydraulic and / or pneumatic transmission, or any other equivalent mechanical transmission means.

  Furthermore, the coupling means 34 is preferably provided with a reciprocity mechanism 35, so that the passage of the second shutter member 32 from its blocking position to its passing position causes the first shutter member 31 to pass from its position. passing to its blocking position.

  In other words, once the first shutter member 31 is placed in a passing position, it is able to be returned to a locking position under the effect of the passage of the second shutter member 32 from its blocking position to its passing position.

  The coupling means 34 is therefore preferably arranged in such a way that the first and the second shutter element can occupy alternately and exclusively their respective passing positions. Advantageously, the coupling means 34 is designed so that the passage of the second shutter member 32 from its passing position to its blocking position takes place substantially simultaneously with the passage of the first shutter member 31 from its blocking position to its passing position.

  Of course, the number of shutter elements implemented within the anti-piercing screen 30 according to the invention is not limited. In particular, according to a preferred embodiment illustrated in FIGS. 1, 2 and 4 to 11, the anti-piercing screen 30 comprises a third shutter element 33. B7040,5 / FR The coupling means 34 is then arranged so that the passage of any one of said shutter elements 31, 32, 33 from its blocking position to its passing position simultaneously causes the two other shutter elements to move towards their respective locking positions, or at the very least to maintain the shutter position. one and / or the other of said two other shutter elements in their locking positions.

  In other words, the coupling means 34 according to the invention is designed such that the shutter elements 31, 32, 33 can be in turn in their passing position, but only one at a time.

  Of course, 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.

  Furthermore, the anti-piercing screen 30 is preferably provided with a control means 36 designed to cause the first shutter member 31 to move from its blocking position to its passing position when a needle 6 enters the chamber 2 through the first puncture zone 4.

  Within the meaning of the invention, the first shutter element 31 is therefore able to pass spontaneously from its blocking position to its passing position, as soon as a needle enters the chamber through the first puncture zone.

  More specifically, the first shutter member 31 is designed so as to first deviate to give way to a needle 6 entering the chamber 2 by the first puncture zone, so that it clears B70405 / EN access to the chamber 2 substantially at the point of entry M1 of said needle 6, and secondly to block the exits of the chamber, in cooperation with the second and / or the third shutter member, at the level of the second puncture area located opposite the entry point M1.

  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.

  In other words, the anti-piercing screen 30 according to the invention preferably has two faces, one being permeable to penetration by the needle 6 and providing a means of passage opposite the first zone of puncture, and the other side forming a impermeable locking means to the perforation and protecting the second puncture area.

  More specifically, the screen 30 is thus able to split in the direction of penetration, so as to have a breakpoint forming an inlet passage taken by the needle.

  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.

  Preferably, the first, second and / or third shutter elements 31, 32, 33 are pivotally mounted, respectively about a first tilting axis (X1X1 '), a second tilting axis (X2X2'), and a third tilting axis (X3X3 ').

  It is remarkable that the tilting movement of the shutter member 31, 32, 33 can be obtained by a rotary assembly, for example in pivot connection, or by a deformable mechanism B7040; 51FR, for example using bending intrinsic elastic material constituting said shutter member.

  Preferably, the first, second and third tilting axes (X, X, '), (X2X2'), (X3X3 ') are fixedly mounted relative to each other on the one hand, and relative to the bedroom 2 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, the first shutter element 31 is formed by a first flap 41 which has two main extension faces forming an extrados 41E and a lower surface 411. Said upper 41E and said lower surface 411 connect a so-called captive end 41C, intended to be mounted rotating around the first tilting axis (X1X1 ') at a free end 41L. For the purposes of the invention, and as shown in FIGS. 1 or 4, the extrados 41E is normally intended to be oriented towards the outside of the chamber 2, at least when the first flap 41 is in position blocking, while said lower surface 411 intended to be oriented towards the inside of the chamber, at least when the first flap 41 is in the locking position.

  Similarly, the second shutter element 32 and / or the third shutter elements 33 are preferably respectively formed by a second shutter 42 and a third shutter 43, each of which has a B70405 / FR extrados 42E, 43E and an intrados 421, 431 connecting a captive end 42C, 43C, adapted to be rotatably mounted about the first and second tilt axes respectively, at a free end 42L, 43L.

  Thus, when the flaps are in the blocking position, their respective undersides are preferably substantially facing each other, at a distance from each other, so that they substantially delimit an internal space, within the chamber 2 .

  In a particularly preferred manner, the first, second and third flaps 41, 42, 43 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.

  In addition, flaps 41, 42, 43 are preferably rigid. They can for this purpose be made of a rigid biocompatible material, either metal, such as titanium, or polymer, such as poly-oxy-methylene (POM), poly-sulfone (PSU), polyolefin (PP, PE), or polyether ether ketone (PEEK)

  Preferably, the first, second and / or third flaps 41, 42, 43 are each mounted in free pivot, or crazy, inside the chamber 2.

  Advantageously, the anti-penetration screen according to the invention, since the shutter elements are mounted idle, requires no additional return member, spring-type, and poses only a slight resistance to 87040. i / FR the penetration of the needle into the chamber. In particular, the erasure of the proximal flap in front of said needle is accomplished virtually effortlessly. The practitioner therefore has no need to force to bring the needle to a functional depth at which the injection or the puncture of fluid can take place.

  The implantable site 1 thus gains simplicity of design, lightness, comfort of use and longevity.

  Preferably, the respective tilt axes of the flaps 41, 42, 43 are preferably located in the chamber 2 near the wall 3, while the extrados of the first, second and / or third flaps 41E, 42E, 4: 3E are substantially contiguous to the wall 3 when said flaps are in the locking position, as shown in FIG. 4.

  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 blocking position to their passing position.

  Thus, the blocking position of the shutter elements will preferably correspond substantially to a so-called raised 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 preventing a needle being inside the chamber to emerge 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 B70405 / FR 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 transition from the passing position to the blocking position constitutes a closing movement.

  According to a preferred embodiment, when the first flap 41 is in a locking position, as illustrated in FIGS. 4 to 7, it bears against the second flap 42.

  More specifically, a portion of the extrados 41E of the first flap 41 is preferably abutted against a lower portion 421 of the second flap 42.

  In a particularly preferred manner, it is the free end 41L of the first flap 41 which is able to bear against the captive end 42C of the second flap 42. Thus, the desired abutment effect is obtained while optimizing the ratio between the area of useful puncture area and the size of the flaps and the device.

  Indeed, the second flap 42, 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 in the direction of movement from the passing position to the blocking position.

  Said first flap 41 is therefore retained, when in the locking position, both by its own tilting axis (X1X1 ') and by that of the second flap 42, against a possible constraint of B70405 / FR thrust on its lower surface 411, especially when a needle 6 hits said underside 411.

  More generally, as illustrated in particular in FIG. 4, the first, the second and the third flaps 41, 42, 43 are preferably juxtaposed so that the extrados portion of the free end of each flaps come overlapping, 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 first, second and third shutter elements 31, 32, 33, and more particularly the tilting axes of the first, second and third flaps, are preferably distributed equidistantly, in an angular offset step substantially equal to 120, about the axis of revolution (XX ') of the device 1, as shown in particular in Figures 4 to 11.

  It is remarkable that such an arrangement allows the shutters to line 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 of the site 1 according to the invention can therefore advantageously be substantially equal to the outer surface of its self-sealing membrane 10. B70405 / FR Thus, the anti-piercing screen according to the invention is preferably divisible, that is to say divided in a plurality of discrete 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.

  According to a preferred embodiment, the first, the second and / or the third tilting axis (XIX1 '), (X2X2'), (X3X3 ') are integral with the first, the second and the third flaps 41, 42, 43 respectively.

  More specifically, as illustrated in FIG. 3, each tilting axis may be materialized by stepped cylindrical protuberances 50, 51 which project at the base and at the top of the captive end 41C, 42C, 43C, said protuberances forming spans for journaling in sliding bearings of conjugate form formed by housings in one and / or the other of the end flanges 15, 17.

  Of course, it is possible to choose the functional clearance between the bearings and the bearing surfaces so as to create a greater or lesser friction, and therefore a more or less pronounced resistance of flaps to tilt. Thus, it is in particular conceivable to choose a coefficient of friction that has sufficient strength to substantially ensure the holding in position of the flaps, despite the jolts caused by the movements of the patient, as the organization of said flaps has not been modified by the penetration of a needle 6.

  Advantageously, the tilting axes linking the flanges 15, 16, 17 are further reinforcing and holding elements in the shape of the site structure 1. 870405 / FR By contributing to improve 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. Indeed, it is possible to confer on said membrane 10 a thickness that is just necessary and sufficient for its function self-sealing, no excess thickness then being absolutely necessary to stiffen the wall 3 to prevent crushing or distension of the chamber 2.

  The structure of the site 1 can thus be lightened.

  Moreover, the extrados 41E, 42E, 43E, 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, whatever the orientation (YY ') taken by said needle 6, to easily slide along the ramp formed by the upper surface when the flap tilts towards the inside the room.

  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 of 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 embodiment illustrated in the figures, each flap is disposed cantilevered with respect to its tilting axis, so that it offers a lever arm which converts B70405 / FR spontaneously the thrust penetration of the needle, even small, in a relatively large engine torque that rotates said flap. Thus, the control means 36 according to the invention may advantageously be formed, for each shutter element, simply by the extrados of the corresponding flap itself.

  As shown in particular in FIG. 3, the lower surface 421 of the second flap 42 preferably has a protruding propulsion section 62 which forms a convex ramp against which the free end 41L of the first flap 41 is able to bear sliding, as shown in Figures 9 and 10, when the first flap 41 moves from its blocking position to its passing position, so as to push the second flap 42 to its locking position.

  Advantageously, the second flap 42 thus integrates a sort of carne allowing the transmission of movement from the first flap 41 to the second flap 42, and more precisely the conversion of the first rotational movement of the first flap along a first trajectory into a second rotational movement. the second component following a second path distinct from the first. Advantageously, the bulge of the propulsion section 62 makes it possible to compensate for the increasing gap between the lower surface 421 of the second flap 42 and the tilting axis (X1X1 ') of the first flap 41 so that the free end 41 L the first flap can remain in contact and effectively and quickly push the second flap 42 from the beginning of the passage of said first flap from its blocking position to its passing position.

  The length of said propulsion section will naturally be adapted to the space left available to the second flap 42 to effect its travel between its passing position on the one hand and its blocking position in abutment against the

  87040: 5 / FR third component 43 on the other hand, in particular so that the first component 41 is not found unintentionally jammed by the second flap 42 during its passage in the pass position.

  Thus, the coupling means 34 will advantageously be formed by the combination of a propulsion cam 61, 62, 63 belonging to one flap and the free end of another flap 41L, 42L, 43L with which it cooperates, at least temporarily.

  Furthermore, the lower surface 421 of the second flap 42 preferably comprises, near the captive end 42C, a recess section 72 that forms a recess in which is placed the free end 41L of the first flap 41 when the latter is in the locking position, as shown in Figures 4 to 7, to provide the clearance, in this case angular, necessary for the second flap 42 so that the latter can move from its locking position to its position bandwidth.

  In other words, the clearance section 72 has a concave profile which avoids any premature interference between the second flap 42 and the first flap 41 during the tilting of said second flap towards the inside of the chamber 2.

  Finally, the lower surface 421 of the second flap 42 comprises a concave rearming portion 82, located beyond the propulsion section 62 towards the free end 42L.

  This resetting section 82 serves two functions.

  On the one hand it clears a space sufficient to allow the free end 41L of the first flap 41 to extend its stroke after passing the propulsion section B704051FR 62, thus maximizing the clearance for the penetration of the needle 6 by said first flap 41 in the passing position.

  On the other hand, it forms the reciprocity mechanism 35 which ensures the mutual coupling between the first and the second flap, in that it is capable, when the first flap 41 is in the conducting position and the second flap 42 is in the locking position, to convert the thrust force that a needle 6 exerts on the extrados 42E of the second flap 42 in a motor torque oriented so as to return the first flap 41 to its locking position.

  As shown in FIG. 11, the passing position of the first flap 41 preferably corresponds to an end-of-travel position, in which the free end 41 L of said first flap abuts against the lower flap 421 of the second flap at a stopping point P of the reset section 82. Said second flap 42 is thus pinched between the free end 41L of the first flap and the captive end 43C of the third flap 43.

  Of course, the curvature of said resetting portion 82 at the stop point P, the nature of the constituent materials of the flaps 41, 42, as well as the position of said stop point P with respect to the first tilting axis (XIX1 ') will be defined so that the resultant of the force exerted by the second flap 42 on the first flap 41, sliding limit, is located on the right side of said first tilting axis, so as to result in a clean return torque to drive the first flap 41 in the proper direction of rotation.

  It is remarkable that in the sense of the invention, the reciprocity does not necessarily mean that the coupling is strictly reversible or permanent, insofar as the first component 41 can, according to a preferred embodiment variant, be recalled by the third component. 43, regardless of

  87040'5 / FR second shutter 42, that is to say that the first shutter element 31 can move from its passing position to its blocking position without causing a change in the position of the second shutter element 32.

  Of course, analogously to the above, each flap 41, 42, 43 will preferably comprise respectively a propulsion section 61, 62, 63, a clearance section 71, 72, 73 and a resetting section 81, 82, 83, such that each pair of flaps has the behavior described above with reference to the first and second flaps.

  Furthermore, according to an alternative embodiment not shown, it is conceivable that one and / or the other of the shutter elements are movably mounted by means of a bistable hinge, preferably deformable. By bistable, it is indicated that the hinge 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 recalled elastically either towards its first equilibrium position, or towards its second equilibrium position. In other words, the hinges can form flip-flops whose tilting threshold is preferably chosen substantially mid-way between their first equilibrium position, which corresponds to the blocking position of the associated shutter element, and their second equilibrium position corresponding to the passing position of said shutter member.

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

  Of course, such a system of bistable hinges will preferably be dimensioned such that the driving torque generated by the hinge associated with a flap during the opening movement of the latter is sufficient to automatically force the return of the other shutters in the closed position, that is to say flip the other hinges.

  The operation of a site 1 according to the invention will now be briefly described with reference to the preferred embodiment illustrated in FIGS. 4 to 11.

  For convenience of description, it will be considered that, initially, the site is in a configuration corresponding to that of FIG. 4, although, as a function of the stresses undergone by the manipulations by the practitioner or movements made by the implanted patient, the initial configuration of the flaps may be a priori and correspond to one or the other of those illustrated in Figures 1 to 11.

  A first needle 6 passes through the wall 3 at the level of the second puncture zone 5, by perforating the membrane 10, in a direction of penetration (YY ') and is at the edge of the chamber 2 at a first point of contact. M1 input.

  As soon as the chamber 2, the bevel of said needle 6 hits the extrados 42E of the second flap 42 which is in the locking position, raised against the wall 3 (Figure 5).

  The penetration force exerted by the practitioner on the needle 6 is transmitted by contact to the second flap 42 and creates a driving torque, represented by the arrow in FIG. 5. Said driving torque drives said second flap 42, which then initiates a rotation, here in the clockwise direction, about its tilting axis (X2X2 '). B7040: i / FR The needle 6 thus pushes the second flap 42 of the wall 3, in particular detaching its free end 42L from the captive end 43C of the third flap 43 on which it rested. In other words, the needle 6 interrupts the continuity of the screen 30 by dissociating the second flap of the third flap, so as to clear a passage through the proximal (outer) face of said screen. The needle 6 continues its progression by sinking into the chamber 2 and progressively spreading the second flap 42 of its way, a little like the way you push the door of a door to enter a room.

  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 of the extrados 42E. If the insertion force of the needle is maintained, the second flap 42 extends its course (FIG. 6) and completes it when its free end 42L abuts against the intrados 431 of the third flap, and more precisely against the free end 43L of said third flap 43 (Figure 7), which is itself supported against the captive portion 41C of the first flap, which is retained by the first axis of tilting (X1X1 '). Depending on its orientation, the needle 6 can then be stopped either directly by the extrados 42E of the second flap 42, or by the intrados 431 of the third flap 43, or by a combination of the two. In particular, the needle 6 can be trapped in the bottom of the well delimited by the extrados 42E of the second flap 42 and the intrados 431 of the third flap 43 as shown in FIG. 7.

  When he feels the resistance to advancement that opposes the antitranspercement screen 30, thanks to the conjugation of the second and third shutters B70405 / FR which block each other, the practitioner deduces that he has reached the functional depth and then actuates the piston of the syringe to proceed with the injection or the 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.

  The flaps 41, 42, 43 then remain substantially, in the absence of any other constraint, in the configuration in which they have been placed (FIGS. 7 and 8).

  If, for example because of a reversal of the site 1 under the skin 11, another needle subsequently approaches the chamber 2 by another entry point (M2) and / or in another direction of penetration (Y2Y2 '), the needle 6 can then meet, as shown in Figure 8, the extrados 41E of the first flap which stands facing it as soon as the wall 3 crossed.

  In a similar manner to that described, the penetration force exerted by the practitioner on the needle 6 is transmitted by contact to the first flap 41 and creates a driving torque, represented by the arrow in FIGS. 8 to 10, which said first flap 41 rotates, here in the clockwise direction, about its tilting axis (X1X1 ').

  The needle 6 thus continues its driving movement into the chamber by spreading the first flap 41 of its path as it progresses. B70405 / EN Depending on the direction of penetration (Y2Y2 ') of the needle, its movement also tends to be accompanied by a relative sliding of its bevel along the slope of the upper surface 41E.

  However, because of the orientation of the second flap 42 previously placed in the driving position, the tilting of the first flap 41 is accompanied by an engagement of its free end 41L on the propulsion section 82 of the second flap 42 (FIG. 9). , so that a return torque is transmitted to said second flap 42 and drives the latter in displacement in a rotational movement, here anti-clockwise, to its locking position. In other words, the flap 41, propelled by the needle 6, displaces by direct contact the second flap 42 to release, as and when, the space required for its opening.

  If the insertion force of the needle, and consequently the repulsion effect of the second flap 42 is sufficiently prolonged, said second flap 42 continues its course (FIG. 10) until it reaches its blocking position , that is to say until its free end 42L abuts against the captive portion 43C of the third flap 43 (Figure 11).

  Similarly, if the insertion force of the needle is sufficiently maintained, the first flap 41 completes its stroke at the stopping point P, when its free end 41L abuts against the free end 42L of the second flap, itself pressed against the captive portion 43C of the third flap 43 which is retained by the third tilting axis (X3X3 ').

  According to its orientation, the needle 6 can then be stopped either directly by the extrados 41E of the first flap 41, or by the lower surface 421 of the second flap 42. It is remarkable that, starting from the configuration of FIG. after removal of the needle, there may be three situations later. B70405 / FR In a first situation, a needle 6 is presented opposite the window left open by the first flap 41, emerging in the vicinity of the second entry point M2. It then freely enters the chamber 2 to its functional depth, without encountering any resistance before reaching abutment against the extrados 41E of the first flap 41 tilted and / or the intrados 421 of the second flap 42 raised, or change the configuration of the shutters.

  In a second situation, a needle 6 emerges in the chamber at the upper surface 43E of the third flap 43. The latter then passes into a passing position by simultaneously bringing the first flap 41 back into its locking position, in a manner analogous to that which has been described above for the first-flap pair.

  In a third situation (not shown), a needle 6 emerges in the chamber 2 at the extrados 42E of the second raised flap. In a substantially similar manner to that described above, the penetration force of the needle is converted, at the resetting section 82, into engine torque which recalls the first flap 41 to its locking position, in the driving in a counter-clockwise direction. This time, the free end 41L of the first flap 41 travels the lower surface 421 of the second flap in the opposite direction to that described above, starting from the resetting section 82 to cross the propulsion section 62 and finally reaching the stretch of clearance 72.

  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 internal space which is circumscribed by the anti-piercing screen 30, before its progression is firmly and surely stopped by the distal shutter element or elements. The anti-screen

  B70405 / FR piercing according to the invention is therefore advantageously a kind of multidirectional valve permeable to proximal penetration but impervious to distal perforation, regardless of 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 substantially biteable from all 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. B70405 / EN

Claims (14)

  Implantable medical device (1) intended for the injection and / or sampling of a fluid in a human or animal body, said device comprising a chamber (2) delimited by a wall (3) which has at least a first zone puncture (4) and a second puncture zone (5) facing each other and each designed to be pierced by a needle (6) for injecting or puncturing said fluid into said chamber (2), said device (1) comprising an anti-piercing screen (30) adapted to prevent a needle (6) entering the chamber (2) through the first puncture area (4) from exiting the chamber (2) by again piercing the wall (3) through the second puncture zone (5), said anti-piercing screen (30) being characterized in that it comprises: at least one first shutter element (31) and a second shutter member (32), each of said first and second elements shutters (31, 32) being puncture-resistant and movably mounted between a passing position in which it allows the passage of a needle (6) through the anti-puncture screen (30) and a locking position, in which it opposes the passage of said anti-piercing screen (30) through the needle (6), and a coupling means (34) operatively associating the first and second shutter members (31, 32) so that the passage of the first shutter element (31) from its blocking position to its passing position causes the second shutter element (32) to pass from its passing position to its blocking position, B70405 / FR   2 - Device according to claim 1 characterized in that the coupling means (34) has a reciprocating mechanism (35), so that the passage of the second shutter member (32) from its blocking position to its passing position causes the first shutter element (31) to pass from its passing position to its blocking position.   3 - Device according to one of claims 1 or 2 characterized in that the first shutter member (31) has a control means (36) adapted to cause the displacement of said first shutter member (31) from its blocking position to its passing position when a needle (6) enters the chamber through the first puncture zone (4).   4 - Device according to one of the preceding claims characterized in that the coupling means (34) comprises a return mechanism designed to transfer the driving energy of the first shutter member (31) to the second shutter member (32) when the first shutter member (31) moves from its blocking position to its passing position.   5 - Device according to one of the preceding claims characterized in that the first and / or the second shutter element (31, 32) are mounted respectively rocking about a first tilting axis (XIX1 ') and a second axis tilting (X2X2 ').   6 - Device according to claim 5 characterized in that one and / or the other of the shutter elements is movably mounted by means of a bistable hinge. B70405 / EN   7 - Device according to claim 5 or 6 characterized in that the first and the second tilting axis (XIX1 '), (X2X2') are fixed mounted and extend substantially parallel to each other.   8 - Device according to one of claims 5 to 7 characterized in that the first and / or the second shutter element (31, 32) respectively, is formed by a first flap (41), respectively a second flap (42) , which has two main extension faces, forming an extrados (41E, 42E) oriented towards the outside of the chamber (2) and an intrados (411, 421) facing towards the inside of the chamber (2), which connect a captive end (41C, 42C) rotatably mounted around the first tilting axis (X1X1 '), respectively of the second tilting axis (X2X2'), at a free end (41L, 42L).   9 - Device according to claim 8 characterized in that the first and / or second flaps (41, 42) are mounted in free pivot within the chamber (2).   10 -Dispositif according to claim 8 or 9 characterized in that the first tilting axis (X1X'1), respectively the second tilting axis (X2X'2), is integral with the first flap (41), respectively with the second part (42).   11 - Device according to one of claims 8 to 10 characterized in that the extrados (41E, 42E) have a convex shape vis-à-vis the outside of the chamber (2).   12 - Device according to one of claims 8 to 11 characterized in that the first and / or second flaps (41, 42) are substantially contiguous to the wall (3) when in the locking position. B70405VFR   13 -Dispositif according to one of claims 8 to 12 characterized in that, when the first flap (41) is in the locking position, its free end (410 bears against the captive portion (42C) of the second flap ( 42).   14 -Dispositif according to one of claims 8 to 13 characterized in that the intrados (421) of the second flap (42) has a protruding portion of propulsion (62) forming a convex ramp against which the free end (41L) the first flap (41) is slidably supported when the first flap (41) moves from its blocking position to its passing position, so as to push the second flap (42) to its locking position. -Dispositif according to one of claims 8 to 14 characterized in that the intrados (421) of the second flap (42) comprises, near its captive end (42C), a recess section (72) returning 15 forming a recess in which is placed the free end (410 of the first flap (41) when the latter is in the locking position, to provide the clearance necessary for the second flap (42) so that the latter can pass from its blocking position 16 - Device according to one of claims 8 to 15 characterized in that the flaps are rigid, and preferably made of a rigid biocompatible material, either metal, titanium type, or polymer, POM type, polyolefin, PSU or PEEK 17 -Dispositif 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 convex continuous puncture zone vis-à-vis - screw from the outside of the device (1). B70405 / FR18 -Device according to one of the preceding claims, characterized in that the chamber (2) has substantially a geometry of axis revolution (XX ') and in that the angular coverage of the puncture zones (4, 5) around said axis of revolution is greater than or equal to 90, preferably greater than or equal to 180, and particularly preferably substantially equal to 360. 19 -Dispositif according to one of the preceding claims characterized in that the anti-piercing screen (30) comprises a third shutter member (33) and in that the coupling means (34) is arranged so that the passage of the any one of said shutter elements (31, 32, 33) from its blocking position to its passing position causes the two other shutter elements to move to their respective blocking positions. 20 -Dispositif according to claims 18 and 19 characterized in that the first, the second and the third shutter element (31, 32, 33) are distributed equidistantly about the axis of revolution (XX ') of the device according to a no angular offset substantially equal to 120. 21 -Dispositif according to claim 20 and any one of claims 8 to 16 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), substantially identical in their shapes and their dimensions and mounted juxtaposed so that the extrados portion of the free end of each of said flaps comes to overlap, in blocking position, the lower surface portion of the captive end of the neighboring shutter. B70405 / EN