WO2008029010A1 - Implantable site with multifacet septum - Google Patents

Implantable site with multifacet septum Download PDF

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Publication number
WO2008029010A1
WO2008029010A1 PCT/FR2007/001399 FR2007001399W WO2008029010A1 WO 2008029010 A1 WO2008029010 A1 WO 2008029010A1 FR 2007001399 W FR2007001399 W FR 2007001399W WO 2008029010 A1 WO2008029010 A1 WO 2008029010A1
Authority
WO
WIPO (PCT)
Prior art keywords
elementary
housing
elementary block
chamber
blocks
Prior art date
Application number
PCT/FR2007/001399
Other languages
French (fr)
Inventor
Pascal Paganon
Jean-Paul Gilbert Ricol
Original Assignee
Compagnie Europeenne D'etude Et De Recherche De Dispositifs Pour L'implantation Par Laparoscopie
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from FR0607905A external-priority patent/FR2905603B1/en
Priority claimed from FR0701487A external-priority patent/FR2913203B1/en
Priority claimed from FR0702482A external-priority patent/FR2914561B1/en
Application filed by Compagnie Europeenne D'etude Et De Recherche De Dispositifs Pour L'implantation Par Laparoscopie filed Critical Compagnie Europeenne D'etude Et De Recherche De Dispositifs Pour L'implantation Par Laparoscopie
Priority to EP07823447A priority Critical patent/EP2066390A1/en
Publication of WO2008029010A1 publication Critical patent/WO2008029010A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A61M2039/022—Subcutaneous access sites for injecting or removing fluids being accessible from all sides, e.g. due to a cylindrically-shaped septum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A61M2039/0226—Subcutaneous access sites for injecting or removing fluids having means for protecting the interior of the access site from damage due to the insertion of a needle

Definitions

  • the present invention relates to the field of implantable medical devices of the type intended for injecting or withdrawing fluid into the body of a patient.
  • the present invention more particularly relates to an implantable medical device for injecting and / or sampling fluid substance in a human or animal body and comprising a housing which defines a chamber for receiving said fluid substance.
  • implantable site intended to form a remote access point allowing the transfer of substance to or from the blood circulation network, the tissues an organ, or an inflatable implant such as a balloon or a constriction ring.
  • such an implantable site is in the form of a housing in which is formed a chamber which communicates, through an outlet port, with a flexible catheter connecting said housing to the target area to which is intended, respectively where comes, the injected substance, respectively taken.
  • the wall of the housing In order to allow access to the chamber by a needle, the wall of the housing generally has a puncture zone formed by a self-sealing membrane, or "septum", made of an elastomeric material so that the tightness of the The site is preserved both when the needle pierces the wall and when it withdraws from it, the hole formed by said needle closing automatically when extracted from it by self-healing elastic phenomenon.
  • a self-sealing membrane or "septum”
  • the implantable sites of the prior art suffer from significant disadvantages.
  • said self-sealing membranes frequently have a small extent so as to be properly held in a housing formed in the housing, and preferably forcibly inserted into said housing to ensure compressive prestressing.
  • the puncture areas of the prior art frequently have a relatively small effective area and accessibility compared to the overall size of the implantable site.
  • the objects assigned to the present invention therefore aim at overcoming the aforementioned drawbacks and at proposing a new implantable medical device intended for the injection and / or sampling of fluid substance in a human or animal body that is particularly easy to access, has a small footprint, and has a long life.
  • Another object assigned to the invention is to provide a new implantable medical device that is particularly simple and compact structure.
  • Another object assigned to the invention is to propose a new implantable medical device whose operation can be ensured even in case of reversal of said device on itself.
  • Another object assigned to the invention is to propose a new implantable medical device which has a particularly robust and stable structure.
  • Another object of the invention is to provide a new implantable medical device achievable for a low cost of manufacture using a small number of standardized parts.
  • Another object assigned to the invention is to propose a new implantable medical device whose structure is modular and scalable.
  • the objects assigned to the invention are also intended to provide a new method of manufacturing an implantable medical device that allows to achieve in a simple and inexpensive way an implantable medical device having good accessibility, long life and reduced size.
  • an implantable medical device intended for the injection and / or sampling of fluid substance in a human or animal body and comprising a housing which delimits a chamber intended to receive said substance.
  • fluid substance said device being characterized in that it comprises a plural puncture zone designed to be pierced by a needle intended to inject or to puncture said fluid substance in said chamber, said plural puncture zone comprising at least a first elementary block and a second elementary block each made of a self-sealing material pierceable by the needle and each having an outer face facing outwardly of the housing an inner face facing the interior of the chamber and a lateral face joining the external face to the inner face, said first and second elementary blocks being arranged side by side so as to have at least a portion of their respective lateral faces substantially in front of each other.
  • an implantable medical device intended for the injection and / or sampling of fluid substance in a human or animal body and comprising a housing which defines a chamber intended to accommodate said fluid substance
  • said manufacturing method being characterized in that it comprises a step (a) of assembly of a puncture zone, plural during which is arranged side by side at least one first elementary block and a second elementary block, each made of a self-sealing material pierceable by the needle, so as to orient their respective outer faces towards the outside of the housing, their respective internal faces towards the inside of the chamber and at least a portion of their respective lateral faces substantially vis-à-vis one another.
  • FIG. 1 shows, in a perspective view, a first embodiment of an implantable medical device according to the invention.
  • FIG. 2 illustrates, in a detail view in perspective, a constituent element of the device represented in FIG.
  • Figure 3 illustrates, in an exploded perspective view partially broken away, the medical device shown in Figure 1.
  • FIG. 4 illustrates, in a perspective view with part broken away and burst, a second embodiment of a device according to the invention.
  • FIG. 5 illustrates, in a perspective view, a third embodiment of medical device according to the invention.
  • Figure 6 illustrates, in a longitudinal sectional view, the device shown in Figure 5.
  • FIG. 7 illustrates, in an exploded perspective view, a part of the device shown in FIGS. 5 and 6.
  • FIG. 8 illustrates, in an exploded perspective view, a fourth embodiment of a medical device according to the invention.
  • FIG. 9 illustrates, in a schematic exploded perspective view, an elementary block according to the invention.
  • the invention relates to an implantable medical device 1 for injecting and / or removing fluid substance (s) in a human or animal body.
  • Such a device also designated by the name “implantable site”, is intended to be implanted surgically in the body of a patient, preferably under the skin of said patient, to form an access point for the introduction or extraction of fluid substance (s) within the body of said patient.
  • Said device 1 can be implemented and adapted for different uses.
  • the device 1 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 substance (s) .
  • 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.
  • 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.
  • 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 with other places in the patient's body and in a deeper way without departing from the scope of the invention.
  • the device 1 comprises a housing 2 which delimits a chamber 3, said chamber 3 being intended to accommodate the injected or withdrawn fluid substance.
  • the device 1 also comprises a puncture zone 4 designed to be pierced by a needle for injecting or puncturing the fluid substance in the chamber.
  • said puncture zone 4 seals the device 1 as well during the stitching by said needle and the fluid transfer as consecutively to the withdrawal of said needle.
  • the puncture zone 4 is plural, and comprises at least a first elementary block 5 and a second elementary block 105, each made of a self-sealing material pierceable by the needle, said first and second elementary block 5, 105 each having an outer face 5E, 105E facing outwardly of the housing, an inner face 51, 1051 oriented towards the inside of the chamber 3, and a lateral face 5L, 105L which joins the outer face 5E, 105E to the inner face 51, 1051, said first elementary block 5 and second elementary block 105 being arranged side by side so as to have at least a portion of their respective lateral faces 5L, 105L substantially facing each other. one of the other.
  • self-sealing material pierceable by the needle means any material that can be used to produce a self-sealing membrane or "septum”, that is to say any material, preferably biocompatible, which can be perforated by a needle, in particular a hollow needle, then capable of automatically resealing the orifice generated by the piercing, after extraction of said needle, by elastic return.
  • the elementary blocks may be made in a biocompatible elastomer such as silicone.
  • the arrangement according to the invention makes it possible to produce a "multifaceted" puncture zone 4, that is to say to divide or fractionate said puncture zone into a plurality of elementary blocks through which a needle can access in room 3.
  • first and second elementary blocks form two adjacent access zones to one and the same chamber 3.
  • an elementary block 5, 105 may be generally in the form of a polyhedron, preferably with six faces, such as a rectangular parallelepiped or a cube, or in the form of an annular crown portion circular, elliptical, polygonal, square, etc.
  • the elementary blocks may form annular ring portions having substantially rectangular and curved external and internal faces.
  • each elementary block 5 is solid and has six faces, in this case one inner face 51 "front”, an outer face 5E "rear", and a side face 5L formed by a set of four faces, preferably planar, designated conventionally as "left side faces” 5LG, "right side face” 5LD, "Upper side face” 5LS and “lower side face” 5Ll.
  • first elementary block 5 and the second elementary block 105 either by superimposing them, for example by placing the lower lateral face 105L1 of the second block 105 in vis-à-vis of the upper lateral face 5LS of the first block 5, or by juxtaposing them, for example by placing the left side face 105LG of the second block 105 facing the right side face 5LD of the first block.
  • the elementary blocks may have a substantially cylindrical or frustoconical shape of revolution, their inner and outer faces corresponding to the base of the form of revolution and their lateral faces then corresponding substantially to a continuous ring .
  • the lateral face 5L will correspond to the meeting of the songs of the elementary block considered, that it has a contour forming a continuous or broken line.
  • said elementary blocks 5, 105 will preferably be substantially identical in their shapes, their dimensions and their composition.
  • the external face 105E of the second elementary block 105 will preferably be disposed substantially in the extension of the outer face 5E of the first elementary block 5.
  • the site 1 advantageously has an outer surface substantially without asperity, which makes it particularly atraumatic and offers little grip tissue gangue.
  • the lateral face portion 5L of the first elementary block 5 and the lateral face portion 105L of the second elementary block 105 situated opposite it have substantially conjugate shapes and extend substantially parallel to each other. one to another.
  • the alignment of the external faces and the similarity of the dimensions of the blocks advantageously makes it possible to obtain a virtually total mutual overlap of the respective lateral surface portions of two neighboring elementary blocks, which optimizes the tightness and the stability of the together so formed.
  • the lateral faces have a curved geometry, and in particular circular, they can be arranged substantially tangentially to each other without departing from the scope of the invention.
  • the first elementary block 5 and the second elementary block 105 are immediately juxtaposed so that their respective lateral faces 5L, 105L are in direct contact with one of the other.
  • first elementary block 5 and the second elementary block 105 are separated from each other, at least partially, by an anti-perforation partition 10 interposed between their lateral face portions 5L, 105L located in vis-à-vis one another, said partition 10 being designed to prevent the transverse penetration of a needle.
  • the anti-perforation partition 10 forms a member, preferably rigid, which is resistant to perforation by a needle and which is located at the interface between two neighboring elementary blocks, so as to prevent a needle from approaching. substantially tangentially the housing 2 to pass successively the first block and the second block without penetrating inside the chamber 3.
  • this arrangement makes it possible to avoid accidental tangential tapping according to which the needle remains blocked in the septum, or would pass through said septum from one side to the other in order to emerge into the tissues, which makes it possible to guarantee a use that is both safe and reliable. of the device 1 according to the invention. Indeed, if the practitioner feels a resistance to the penetration of the needle immediately after stitching the site 1, he deduces that it abuts against a partition 10 and can then correct or resume its stitching gesture so as to be certain that the end of the needle has actually penetrated into the chamber and reaches a functional depth compatible with the fluid transfer.
  • the antiperforation partition 10 is formed by a plate, preferably substantially flat, the thickness of which is preferably substantially between 0.3 mm and 2 mm, and in a particularly preferred manner, between 0.5 and 1.5 mm.
  • the partition 10 defines a minimum separation distance between the first and the second elementary block 5, 105, which corresponds substantially to the length of a notional segment normal to the corresponding side walls 5L, 105L and joining the respective points of said walls. sideways closest to each other.
  • first elementary block 5 and the second elementary block 105 preferably form a puncture zone 4 generally convex relative to the outside of the device 1.
  • this convexity can be obtained either by means of elementary blocks 5, 105 having a curved shape with the curvature oriented outwards, or by means of polyhedral elementary blocks housed in separate housing walls and intersecting, or else by means of polyhedral elementary blocks having lateral faces, in particular left and / or right, inclined with respect to the inner face 51 and / or outer face 5E, so that the disposition of said lateral faces parallel to one another leads to the formation of a projecting edge at the interface between the outer faces of neighboring blocks.
  • elementary blocks with curved or rounded shapes will be used, and particularly preferably elementary blocks whose external faces 5E, 105E have continuity of curvature in order to avoid abrupt transitions between said elementary blocks.
  • the thickness of the elementary blocks 5, 105 measured between the outer face 5E, 105E and the inner face 51, 1051 will preferably be substantially constant, so that the convexity of the puncture zone 4 results in a convexity substantially similar to the chamber 3 itself.
  • such an arrangement makes it possible to maximize the useful volume of said chamber 3, to provide access thereto according to numerous directions of approach of the needle, and thus to optimize the compactness and accessibility of the site 1.
  • the chamber 3, and more generally the housing 2 has a substantially cylindrical geometry generated by a base surface 11 along a generating axis (XX ').
  • Cylindrical shape denotes globally any shape obtained when any base surface 11 scans any predetermined curve forming said generator axis (XX ').
  • the generating axis (XX ') is, however, rectilinear.
  • said generator axis is vertical (it being understood that it will preferably be oriented substantially parallel to the surface of the skin once the site 1 implanted).
  • the base surface 11 may advantageously be formed by a disk, as shown in the variants illustrated in the figures.
  • the base surface may also be formed by a disk portion, such as an angular sector corresponding to the portion between 2 distinct radii and the arc of the circle joining the ends of said radii , a crescent, a half-disc, or a neighborhood.
  • the base surface 11 may also correspond to an elliptical or ellipsoidal surface, or a polygonal surface such as a triangle, a rectangle, a square, a hexagon or any other type of polygon, preferably convex and regular.
  • the base surface 11 has substantially constant dimensions along the generator axis (XX '), and the housing is closed at each of its ends by a terminal flange 12, 13, preferably resistant to the perforation.
  • the base surface 11 may also have variable dimensions along the generator axis (XX '), that is to say that the site 1 has a cross section, considered in a plane normal to the generator axis (XX '), of variable size along the point of said generator axis (XX') where it is placed, the housing 2 can thus be in an ovoid, pear-shaped, spherical, etc., without departing from the frame of the invention.
  • the housing 2 can also be in the form of a polyhedron, such as a cube or a rectangular parallelepiped, the edges then being preferably rounded by 5
  • connection holidays in order to keep the site a substantially atraumatic character.
  • such a global polyhedron shape makes it easier to assemble the site 1 but also to benefit from particularly stable support surfaces against the tissues once said implanted site.
  • At least one of the end flanges 13 is provided with a connecting piece 14 forming a conduit for connecting an outlet opening opening in the chamber 3 to a catheter (not shown).
  • the connecting member 14 and the generating axis (XX ') are coaxial.
  • the puncture zone 4 extends at least in part, particularly preferably (more than 50%), or even exclusively on the side wall of the cylindrical housing 2.
  • the angular coverage of the puncture zone 4, considered in a plane normal to the generating axis (XX '), is greater than or equal to 90 °, preferably greater than or equal to 180 °, and particularly preferably greater than or equal to 300 °, or substantially equal to 360 °.
  • the chamber 3 is effectively accessible, that is to say the wall of the casing 2 pierceable, on at least a quarter, preferably half, and even more preferably on almost the entire circumference lateral of the case.
  • the puncture zone 4, and more generally the housing 2 will have a generally invariant geometry by rotation of order 2, 3, 4 and / or 6 around the generator axis (XX '), that is to say to say invariant by rotation of 180 °, 120 °, 90 ° or 60 °, in particular in the case of a polyhedral casing, or even a geometry of revolution totally invariant by rotation, which makes the device 1 almost insensitive to a reversal on itself. same, since it retains its functionality and accessibility in many angular configurations relative to the skin surface.
  • the puncture zone 4 may comprise for this purpose a plurality of elementary blocks 5, 105, 205, 305, 405, 505, 605, 705 arranged side by side so as to form an annular layer 20 whose contour substantially corresponds to that of the base area 11.
  • each elementary block covers an angular portion (measured around the generator axis (XX ') in a plane normal to the latter) which corresponds to a radial subdivision of the total angular coverage of the puncture zone 4.
  • an annular layer 20 may comprise two elementary blocks, or three elementary blocks, or four elementary blocks (FIGS. 5, 6, 7 and 8), or six elementary blocks, or eight or more elementary blocks arranged in a row to forming a kind of constituent wall of said layer 20.
  • the (or) antiperforation partition (s) 10 extends (s) in the chamber 3 so as to form an anti-piercing screen 21, as shown in Figure 7, said screen 21 being designed to prevent a needle from passing through the housing 2 from one side to the other.
  • several partitions 10 can meet substantially in the center of the chamber to form a spider or a star.
  • the elementary blocks 5, 105 preferably have lateral bearing faces 5L, 105L and more particularly left side faces 5LG, 105LG and right 5LD, 105LD which converge towards the inside of the chamber, and preferably extending in intersecting planes whose intersection coincides with the generating axis (XX '), so that said elementary blocks come into self-locking support against the partitions 10 (or against each other) in the direction penetration of the needle.
  • the elementary blocks can form a kind of discharge arcs which spontaneously oppose a resistance to depression when a centripetal radial penetration stress is exerted on their outer face 5E, 105E and directed towards the interior of the chamber. 3, and more particularly towards the generator axis (XX ').
  • the device 1 may advantageously comprise a plurality of annular layers 20, 2OA, 2OB superimposed in the direction of the generator axis (XX ').
  • the site 1 according to the invention may have a plurality of elementary blocks stacked with respect to each other, so as to form a matrix structure delimiting a closed contour of the chamber 3.
  • the puncture zone 4 may advantageously have a matrix structure comprising at least two lines (the horizontal rows corresponding to the annular layers) and at least two columns (the vertical rows of blocks belonging to the successive annular layers), each element of said matrix being formed by an elementary block.
  • the puncture zone 4 according to the invention is preferably modular and split into a plurality of elementary blocks, in this case at least three, separated from each other in at least two intersecting interruption surfaces, preferably substantially planar and orthogonal.
  • said blocks are arranged side by side in two distinct directions of space.
  • the puncture zone 4 preferably has a first level (or first layer) comprising at least a first and a second elementary block arranged side by side and separated at least in part, and preferably entirely, by a first zone substantially extending in a first plane, in this case a vertical plane containing the generator axis (XX '), and at least a second level comprising at least a third elementary block which overlaps at least partially the first and / or the second elementary block and which is separated at least in part, and preferably totally, from it, or thereof, by a second interruption zone extending substantially along a second secant plane, and in this case orthogonal, in the foreground.
  • the different annular layers 20, 20A, 20B may be separated from each other by intermediate flanges 21, 22, preferably rigid and resistant to perforation.
  • said intermediate flanges 21, 22 are formed by washers disposed substantially normally to the generator axis (XX ').
  • the puncture zone 4 can be partitioned both radially, by the partitions 10, and transversely by the intermediate flanges 21, 22, the assembly thus forming a honeycomb structure.
  • the partitions 10 may also be integral with one or more intermediate flanges 21, 22.
  • the elementary blocks 5, 105, 205, 305, 405, 505, 605, 705 are all identical, in their formats and their compositions.
  • the first and the second elementary block are each formed by a complete annular segment, preferably obtained by scanning a rectangular or square cross section around the generator axis (XX '), said annular segments being simply stacked one above the other, and optionally separated by an intermediate flange.
  • the device comprises a modular honeycomb frame 30 which comprises several pillars 31, preferably connected by independent cross members 32, said pillars 31 forming, preferably in combination with said sleepers 32, frames in which the elementary blocks 5, 105, 205, 305 are embedded.
  • a modular structure is advantageously scalable, and allows the need to mount as many successive rows of elementary blocks as is necessary to obtain a package of length (in this case of height) total freely chosen by the manufacturer.
  • Said pillars 31 may advantageously be integral with the anti-perforation partitions 10.
  • cross members 32 may be either one-piece, that is to say, form, between two stages corresponding to a horizontal row of elementary blocks (or to an annular layer 20), a plate in one piece, such that this is illustrated in FIG. 8, or else forming independent shelf-type elements corresponding to radial subdivisions of annular plate, for example quarter-ring in FIG. 7.
  • said sleepers 32 form Ie or the intermediate flanges.
  • the pillars 31 and / or the cross members 32 are provided with indentations 33 delimited by stop edges 34, said indentations 33 being designed to receive and hold in position, in particular at a fixed radial distance with respect to the axis.
  • the indentations 33 formed in the pillars 31 may be formed by open circular grooves centered on the generating axis (XX '), whereas the crosspieces 32 are provided with tabs 35 of conjugate form allowing insertion and free axial displacement, along said generator axis (XX '), said sleepers relative to the pillars 31 while ensuring the radial locking of said sleepers 32.
  • the housing 2 by first positioning the pillars 31 and fixing them in a terminal flange 12, 13, then raising between each pair of adjacent pillars a zone of puncture constituted by alternating elementary blocks 5 and sleepers 32 stacked one above the other.
  • the first and / or second elementary block 5, 105 are provided with at least one tenon 40 and / or at least one mortise 41 designed to allow their attachment to one another or to a fixed element of the case.
  • each elementary block may be provided with two pins 40 projecting respectively on its upper lateral surfaces 5LS and lower lateral 5Ll so as to be housed in a mortise 41 conjugate dug in the intermediate flange 21, 22 or in the corresponding end flange 12, 13, so as to block radially position said elementary block.
  • the system of tenons and mortises gives the elementary blocks a self-locking and self-centering character which facilitates the assembly and improves the structural robustness of the site 1.
  • the first and the second elementary blocks 5, 105 may be intrinsically distinct from each other, that is to say constitute two physically and kinematically independent entities, that we can report independently of each other on site 1 during assembly.
  • the first and the second elementary blocks 5, 105 are interconnected by a connecting strip 50.
  • said joining strip 50 is in the form of a ribbon whose height, in this case measured parallel to the generating axis (XX '), is substantially equal to that of the external faces 5E, 105E, and whose the thickness, in this case measured in a radial direction orthogonal to said generating axis (XX '), is preferably between 0.3 mm and 1 mm, and particularly preferably close to 0.5 mm.
  • the joining strip 50 is integral with the first and / or the second elementary block 5, 105, and particularly preferably with all the elementary blocks 5, 105, 205, 305 forming a single annular layer 20.
  • the joining strip 50 forms a peripheral rim which connects the outer faces 5E, 105E, 205E, 305E of the elementary blocks substantially in the contour of the base surface 11.
  • the joining strip 50 surrounds the elementary blocks in a closed contour, and forms with said elementary blocks a sort of toothed belt intended to be attached to a perforated reinforcement formed of pillars 31.
  • the lateral faces 5L, 105L of two adjacent elementary blocks 5, 105 connected by the same joining strip 50 are spaced apart by a notch 51 whose shape and dimensions correspond to substantially to those of the anti-perforation partition 10 to be inserted between the two blocks.
  • a joining strip 50 according to the invention makes it possible on the one hand to secure the elementary blocks, and thus to simplify their handling during assembly while improving the overall stability and robustness of the housing, and on the other hand partly, thanks to its intrinsic elasticity, to exert a centrifugal radial compressive force which tends to press the elementary blocks against the pillars 31.
  • the present invention is capable of being subject to variations, the person skilled in the art being able to appreciate the number, the shape and the dimensions of the elementary blocks, and if necessary the modular reinforcing elements of type pillars 31 or sleepers 32 depending on the size, shape, and destination of the site 1, and more particularly the housing 2 and the chamber 3.
  • the present invention also relates to a method of manufacturing an implantable medical device 1 as described above, and more particularly to an implantable site 1 intended for injecting and / or sampling fluid substance in a human body or animal and comprising a housing 2 which defines a chamber 3 for accommodating said fluid substance.
  • said manufacturing method comprises a step (a) of assembling a plural puncture zone during which at least a first elementary block and a second elementary element are arranged side by side. each in a self-sealing material pierceable by the needle, so as to orient their respective outer faces 5E, 105E towards the outside of the housing 2, their respective inner faces 51, 1051 towards the inside of the chamber 3, and least one portion of their respective lateral faces 5L, 105L substantially vis-à-vis one another.
  • the step (a) of assembly of the plural puncture zone may comprise a sub-step ( a) of axial approach during which the first and / or the second elementary block 5, 105 is reported in a reception structure, such as a terminal or intermediate flange, in a direction substantially parallel to the generating axis (XX ') of the housing 2.
  • the axial approach sub-step (a1) is repeated with as many elementary blocks as necessary to obtain a complete annular layer around the generator axis (XX ').
  • the assembly step (a) preferably comprises an elevation sub-step (a2) in which at least one elementary block is disposed over the elementary block or blocks, preferably by axial approach. already in place.
  • a sub-step (a3) of interposition can be implemented between the sub-step (ai) of axial approach and the sub-step (a2) of elevation, during which is disposed over the elementary block or blocks already in place one or more sleepers 32.
  • the step (a) of assembly of the plural puncture zone may include a sub-step (a4) radial approach to in which one or more elementary blocks are reported, individually or collectively, by driving them into the frames in a centripetal radial direction substantially normal to the generating axis (XX ')
  • the manufacturing method comprises a step (b) of tangential prestressing, preferably concomitant with the substep (ai) of axial approach or (a4) of radial approach to during which the elementary blocks are deformed by compression, either in contact with the neighboring elementary blocks, or in contact with the bearing surfaces of the anti-perforation partitions 10, so as to force the approach of the left lateral surface 5LG and the right side surface 5LD belonging to the same elementary block 5.
  • the manufacturing method also comprises a step (c) of axial compression in which the mutual engagement of the end flanges 12, 13 is forced, for example by using the pillars 31 as tie rods, so as to preclude also to constrain the elementary blocks in axial compression.
  • the manufacturing method according to the invention may further comprise a step (d) of coupling during which the neighboring elementary blocks are intimately connected in pairs, for example by fusing, at least partially, by chemical, photochemical or thermal, their respective lateral faces located vis-à-vis one another, or by injecting around the elementary blocks and / or between neighboring building blocks a grouting substance.
  • the device according to the invention advantageously has a modular structure that simplifies and standardizes its assembly, while ensuring a good seal and a long life of said site.
  • the implantable site according to the invention has both an optimized accessibility and a small footprint, the constituent elements of the puncture area occupying a relatively modest volume compared to the total useful volume of the site.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
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Abstract

The invention relates to an implantable medical device (1) intended for injection and/or sampling of fluid substance in a human or animal body, and comprising a housing (2) that delimits a chamber (3) intended to receive said fluid substance, said device being characterized in that it comprises a pleural puncture zone (4) designed to be able to the pierced by a needle intended for injecting or sampling said fluid substance in said chamber (3), said pleural puncture zone (4) comprising at least a first elementary block (5) and a second elementary block (105) which are each made of a self-occluding material that can be pierced by the needle, and which each have an outer face (5E, 105E) oriented towards the outside of the housing (2), an inner face (51, 1051) oriented towards the inside of the chamber (3), and a lateral face (5L, 105L) joining the outer face to the inner face, said first and second elementary blocks (5, 105) being arranged side by side in such a way as to present at least a portion of their respective lateral faces (5L, 105L) substantially opposite each other. Implantable sites.

Description

SITE IWIPLANTABLE AVEC SEPTUM MULTIFACETTES IWIPLANTABLE SITE WITH SEPTUM MULTIFACETTES
La présente invention se rapporte au domaine des dispositifs médicaux implantables de type destinés à l'injection ou au prélèvement de substance fluide dans le corps d'un patient.The present invention relates to the field of implantable medical devices of the type intended for injecting or withdrawing fluid into the body of a patient.
La présente invention concerne plus particulièrement un dispositif médical implantable destiné à l'injection et/ou au prélèvement de substance fluide dans un organisme humain ou animal et comprenant un boîtier qui délimite une chambre destinée à accueillir ladite substance fluide.The present invention more particularly relates to an implantable medical device for injecting and / or sampling fluid substance in a human or animal body and comprising a housing which defines a chamber for receiving said fluid substance.
Il est connu d'implanter sous la peau d'un patient un dispositif médical, dit « site implantable », destiné à former un point d'accès déporté permettant le transfert de substance vers, ou depuis, le réseau de circulation sanguine, les tissus d'un organe, ou encore un implant gonflable tel qu'un ballonnet ou un anneau de constriction.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 substance to or from the blood circulation network, the tissues an organ, or an inflatable implant such as a balloon or a constriction ring.
Généralement, un tel site implantable se présente sous la forme d'un boîtier au sein duquel est ménagé une chambre qui communique, par un orifice de sortie, avec un cathéter souple reliant ledit boîtier à la zone cible à laquelle est destinée, respectivement d'où provient, la substance injectée, respectivement prélevée.Generally, such an implantable site is in the form of a housing in which is formed a chamber which communicates, through an outlet port, with a flexible catheter connecting said housing to the target area to which is intended, respectively where comes, the injected substance, respectively taken.
Afin d'autoriser l'accès à la chambre par une aiguille, la paroi du boîtier présente généralement une zone de ponction formée par une membrane auto-obturante, ou « septum », réalisée dans un matériau élastomère de telle sorte que l'étanchéité du site est préservée aussi bien lorsque l'aiguille transperce la paroi que lorsqu'elle s'en retire, le trou formé par ladite aiguille se refermant automatiquement lors de l'extraction de celle-ci par phénomène d'auto-cicatrisation élastique. Bien qu'ils donnent globalement satisfaction, les sites implantables de l'art antérieur souffrent cependant d'inconvénients non négligeables.In order to allow access to the chamber by a needle, the wall of the housing generally has a puncture zone formed by a self-sealing membrane, or "septum", made of an elastomeric material so that the tightness of the The site is preserved both when the needle pierces the wall and when it withdraws from it, the hole formed by said needle closing automatically when extracted from it by self-healing elastic phenomenon. Although they give overall satisfaction, the implantable sites of the prior art, however, suffer from significant disadvantages.
En effet, afin de garantir la tenue mécanique du site, ainsi que son étanchéité même lorsque que celui-ci a été piqué à de multiples reprises, il est généralement nécessaire de prévoir des membranes auto-obturantes relativement épaisses.Indeed, in order to ensure the mechanical strength of the site, and its tightness even when it has been stitched multiple times, it is generally necessary to provide relatively thick self-sealing membranes.
En outre, lesdites membranes auto-obturantes présentent fréquemment une faible étendue de sorte à pouvoir être convenablement maintenues dans un logement ménagé dans le boîtier, et de préférence insérées à force dans ledit logement afin d'assurer leur précontrainte en compression.In addition, said self-sealing membranes frequently have a small extent so as to be properly held in a housing formed in the housing, and preferably forcibly inserted into said housing to ensure compressive prestressing.
Par conséquent, les zones de ponction de l'art antérieur présentent fréquemment une superficie utile et une accessibilité relativement restreintes en comparaison de l'encombrement global du site implantable.As a result, the puncture areas of the prior art frequently have a relatively small effective area and accessibility compared to the overall size of the implantable site.
Les objets assignés à la présente invention visent par conséquent à remédier aux inconvénients susmentionnés et à proposer un nouveau dispositif médical implantable destiné à l'injection et/ou au prélèvement de substance fluide dans un organisme humain ou animal qui soit particulièrement facile d'accès, présente un faible encombrement, et possède une importante longévité.The objects assigned to the present invention therefore aim at overcoming the aforementioned drawbacks and at proposing a new implantable medical device intended for the injection and / or sampling of fluid substance in a human or animal body that is particularly easy to access, has a small footprint, and has a long life.
Un autre objet assigné à l'invention vise à proposer un nouveau dispositif médical implantable qui soit de structure particulièrement simple et compacte.Another object assigned to the invention is to provide a new implantable medical device that is particularly simple and compact structure.
Un autre objet assigné à l'invention vise à proposer un nouveau dispositif médical implantable qui permette au praticien de réaliser un piquage de manière fiable et sûre. Un autre objet assigné à l'invention vise à proposer un nouveau dispositif médical implantable atraumatique qui minimise la gêne occasionnée au patient.Another object assigned to the invention is to propose a new implantable medical device that allows the practitioner to perform a stitching in a reliable and safe manner. Another object assigned to the invention is to propose a new atraumatic implantable medical device which minimizes the inconvenience caused to the patient.
Un autre objet assigné à l'invention vise à proposer un nouveau dispositif médical implantable dont le fonctionnement puisse être assuré même en cas de retournement dudit dispositif sur lui-même.Another object assigned to the invention is to propose a new implantable medical device whose operation can be ensured even in case of reversal of said device on itself.
Un autre objet assigné à l'invention vise à proposer un nouveau dispositif médical implantable qui présente une structure particulièrement robuste et stable.Another object assigned to the invention is to propose a new implantable medical device which has a particularly robust and stable structure.
Un autre objet assigné à l'invention vise à proposer un nouveau dispositif médical implantable réalisable pour un coût de fabrication modique à l'aide d'un petit nombre de pièces standardisées.Another object of the invention is to provide a new implantable medical device achievable for a low cost of manufacture using a small number of standardized parts.
Un autre objet assigné à l'invention vise à proposer un nouveau dispositif médical implantable dont la structure soit modulaire et évolutive.Another object assigned to the invention is to propose a new implantable medical device whose structure is modular and scalable.
Les objets assignés à l'invention visent également à proposer un nouveau procédé de fabrication d'un dispositif médical implantable qui permette de réaliser de façon simple et peu coûteuse un dispositif médical implantable présentant une bonne accessibilité, une longévité importante et un encombrement réduit.The objects assigned to the invention are also intended to provide a new method of manufacturing an implantable medical device that allows to achieve in a simple and inexpensive way an implantable medical device having good accessibility, long life and reduced size.
Les objets assignés à l'invention sont atteints à l'aide d'un dispositif médical implantable destiné à l'injection et/ou au prélèvement de substance fluide dans un organisme humain ou animal et comprenant un boîtier qui délimite une chambre destinée à accueillir ladite substance fluide, ledit dispositif étant caractérisé en ce qu'il comporte une zone de ponction plurale conçue pour pouvoir être transpercée par une aiguille destinée à injecter ou à ponctionner ladite substance fluide dans ladite chambre, ladite zone de ponction plurale comprenant au moins un premier bloc élémentaire et un second bloc élémentaire réalisés chacun dans un matériau auto-obturant transperçable par l'aiguille et présentant chacun une face externe orientée vers l'extérieur du boîtier, une face interne orientée vers l'intérieur de la chambre et une face latérale joignant la face externe à la face interne, lesdits premier et second bloc élémentaire étant disposés côte à côte de sorte à présenter au moins une portion de leurs faces latérales respectives sensiblement en vis-à-vis l'une de l'autre.The objects assigned to the invention are achieved by means of an implantable medical device intended for the injection and / or sampling of fluid substance in a human or animal body and comprising a housing which delimits a chamber intended to receive said substance. fluid substance, said device being characterized in that it comprises a plural puncture zone designed to be pierced by a needle intended to inject or to puncture said fluid substance in said chamber, said plural puncture zone comprising at least a first elementary block and a second elementary block each made of a self-sealing material pierceable by the needle and each having an outer face facing outwardly of the housing an inner face facing the interior of the chamber and a lateral face joining the external face to the inner face, said first and second elementary blocks being arranged side by side so as to have at least a portion of their respective lateral faces substantially in front of each other.
Les objets assignés à l'invention sont également atteints à l'aide d'un procédé de fabrication d'un dispositif médical implantable destiné à l'injection et/ou au prélèvement de substance fluide dans un organisme humain ou animal et comprenant un boîtier qui délimite une chambre destinée à accueillir ladite substance fluide, ledit procédé de fabrication étant caractérisé en ce qu'il comporte une étape (a) d'assemblage d'une zone de ponction, plurale au cours de laquelle on dispose côte à côte au moins un premier bloc élémentaire et un second bloc élémentaire, réalisés chacun dans un matériau auto-obturant transperçable par l'aiguille, de manière à orienter leurs faces externes respectives vers l'extérieur du boîtier, leurs faces internes respectives vers l'intérieur de la chambre et au moins une portion de leurs faces latérales respectives sensiblement en vis-à-vis l'une de l'autre.The objects assigned to the invention are also achieved by means of a method of manufacturing an implantable medical device intended for the injection and / or sampling of fluid substance in a human or animal body and comprising a housing which defines a chamber intended to accommodate said fluid substance, said manufacturing method being characterized in that it comprises a step (a) of assembly of a puncture zone, plural during which is arranged side by side at least one first elementary block and a second elementary block, each made of a self-sealing material pierceable by the needle, so as to orient their respective outer faces towards the outside of the housing, their respective internal faces towards the inside of the chamber and at least a portion of their respective lateral faces substantially vis-à-vis one another.
D'autres objets, caractéristiques et avantages de l'invention apparaîtront plus en détails à la lecture de la description qui suit, ainsi qu'à l'aide des dessins annexés, fournis à titre purement illustratif et non limitatif, parmi lesquels :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:
- La figure 1 représente, selon une vue en perspective, une première variante de réalisation d'un dispositif médical implantable conforme à l'invention. - La figure 2 illustre, selon une vue de détail en perspective, un élément constitutif du dispositif représenté à la figure 1.- Figure 1 shows, in a perspective view, a first embodiment of an implantable medical device according to the invention. FIG. 2 illustrates, in a detail view in perspective, a constituent element of the device represented in FIG.
- La figure 3 illustre, selon une vue en perspective éclatée avec arrachement partiel, le dispositif médical représenté sur la figure 1.- Figure 3 illustrates, in an exploded perspective view partially broken away, the medical device shown in Figure 1.
- La figure 4 illustre, selon une vue en perspective avec arrachement et éclatement partiels, une seconde variante de réalisation d'un dispositif conforme à l'invention.- Figure 4 illustrates, in a perspective view with part broken away and burst, a second embodiment of a device according to the invention.
- La figure 5 illustre, selon une vue en perspective, une troisième variante de réalisation de dispositif médical conforme à l'invention.- Figure 5 illustrates, in a perspective view, a third embodiment of medical device according to the invention.
- La figure 6 illustre, selon une vue en coupe longitudinale, le dispositif représenté à la figure 5.- Figure 6 illustrates, in a longitudinal sectional view, the device shown in Figure 5.
- La figure 7 illustre, selon une vue en perspective éclatée, une partie du dispositif représenté sur les figures 5 et 6.FIG. 7 illustrates, in an exploded perspective view, a part of the device shown in FIGS. 5 and 6.
- La figure 8 illustre, selon une vue en perspective éclatée, une quatrième variante de réalisation d'un dispositif médical conforme à l'invention.- Figure 8 illustrates, in an exploded perspective view, a fourth embodiment of a medical device according to the invention.
- La figure 9 illustre, selon une vue schématique en perspective éclatée, un bloc élémentaire conforme à l'invention.- Figure 9 illustrates, in a schematic exploded perspective view, an elementary block according to the invention.
L'invention concerne un dispositif médical implantable 1 destiné à l'injection et/ou au prélèvement de substance(s) fluide(s) dans un organisme humain ou animal.The invention relates to an implantable medical device 1 for injecting and / or removing fluid substance (s) in a human or animal body.
Un tel dispositif 1 , également désigné par l'appellation « site implantable », est destiné à être implanté chirurgicalement dans le corps d'un patient, de préférence sous la peau dudit patient, en vue de constituer un point d'accès pour l'introduction ou l'extraction de substance(s) fluide(s) au sein du corps dudit patient.Such a device 1, also designated by the name "implantable site", is intended to be implanted surgically in the body of a patient, preferably under the skin of said patient, to form an access point for the introduction or extraction of fluid substance (s) within the body of said patient.
Ledit dispositif 1 peut être mis en œuvre et adapté pour différents usages.Said device 1 can be implemented and adapted for different uses.
En particulier, le dispositif 1 conforme à l'invention peut être conçu pour l'injection et/ou le prélèvement de fluide dans un organe ou dans le système circulatoire, par exemple pour permettre l'injection de substance(s) médicamenteuse(s). Selon une variante particulière de cette application, ledit dispositif 1 peut être adapté pour former une veine ou une artère artificielle que le praticien peut piquer à travers la peau, à la manière d'une veine naturelle, afin d'injecter une substance thérapeutique ou de prélever du sang.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 substance (s) . 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.
Le dispositif 1 conforme à l'invention peut également être adapté pour alimenter des réservoirs implantés associés par exemple à des pompes à insuline ou à antalgique.The device 1 according to the invention can also be adapted to supply implanted reservoirs associated for example with insulin or analgesic pumps.
Ledit dispositif 1 peut enfin être adapté pour l'injection et la ponction de fluide dans le compartiment gonflable ou dégonflable d'un implant chirurgical, tel qu'un sphincter artificiel, un ballonnet ou encore un anneau gastrique destiné à réaliser une constriction de l'estomac pour lutter contre l'obésité.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.
Dans ce qui suit, on considérera plus particulièrement que le dispositif 1 constitue un dispositif hypodermique, c'est-à-dire qu'il est destiné à être positionné juste sous la peau du patient, bien que ledit dispositif puisse être implanté à d'autres endroits dans le corps du patient et de manière plus profonde sans sortir du cadre de l'invention. Selon l'invention, le dispositif 1 comprend un boîtier 2 qui délimite une chambre 3, ladite chambre 3 étant destinée à accueillir la substance fluide injectée ou prélevée.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 with 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 housing 2 which delimits a chamber 3, said chamber 3 being intended to accommodate the injected or withdrawn fluid substance.
Le dispositif 1 comporte également une zone de ponction 4 conçue pour pouvoir être transpercée par une aiguille destinée à injecter ou à ponctionner la substance fluide dans la chambre.The device 1 also comprises a puncture zone 4 designed to be pierced by a needle for injecting or puncturing the fluid substance in the chamber.
Avantageusement, ladite zone de ponction 4 assure l'étanchéité du dispositif 1 aussi bien lors du piquage par ladite aiguille et du transfert de fluide que consécutivement au retrait de ladite aiguille.Advantageously, said puncture zone 4 seals the device 1 as well during the stitching by said needle and the fluid transfer as consecutively to the withdrawal of said needle.
Selon une caractéristique importante de l'invention, la zone de ponction 4 est plurale, et comprend au moins un premier bloc élémentaire 5 et un second bloc élémentaire 105, réalisés chacun dans un matériau auto-obturant transperçable par l'aiguille, lesdits premier et second bloc élémentaire 5, 105 présentant chacun une face externe 5E, 105E orientée vers l'extérieur du boîtier, une face interne 51, 1051 orientée vers l'intérieur de la chambre 3, et une face latérale 5L, 105L qui joint la face externe 5E, 105E à la face interne 51, 1051, lesdits premier bloc élémentaire 5 et second bloc élémentaire 105 étant disposés côte à côte de sorte à présenter au moins une portion de leurs faces latérales respectives 5L, 105L sensiblement en vis-à-vis l'une de l'autre.According to an important characteristic of the invention, the puncture zone 4 is plural, and comprises at least a first elementary block 5 and a second elementary block 105, each made of a self-sealing material pierceable by the needle, said first and second elementary block 5, 105 each having an outer face 5E, 105E facing outwardly of the housing, an inner face 51, 1051 oriented towards the inside of the chamber 3, and a lateral face 5L, 105L which joins the outer face 5E, 105E to the inner face 51, 1051, said first elementary block 5 and second elementary block 105 being arranged side by side so as to have at least a portion of their respective lateral faces 5L, 105L substantially facing each other. one of the other.
Par « matériau auto-obturant transperçable par l'aiguille », on désigne tout matériau pouvant être utilisé pour réaliser une membrane auto-obturante ou « septum », c'est-à-dire tout matériau, de préférence biocompatible, pouvant être perforé par une aiguille, notamment une aiguille creuse, puis capable de reboucher automatiquement l'orifice généré par le perçage, après extraction de ladite aiguille, par retour élastique. Par exemple, les blocs élémentaires pourront être réalisés dans un élastomère biocompatible tel que le silicone.By "self-sealing material pierceable by the needle" means any material that can be used to produce a self-sealing membrane or "septum", that is to say any material, preferably biocompatible, which can be perforated by a needle, in particular a hollow needle, then capable of automatically resealing the orifice generated by the piercing, after extraction of said needle, by elastic return. For example, the elementary blocks may be made in a biocompatible elastomer such as silicone.
Avantageusement, l'agencement conforme à l'invention permet de réaliser une zone de ponction 4 « multifacettes », c'est-à-dire de diviser ou de fractionner ladite zone de ponction en une pluralité de blocs élémentaires par lesquels une aiguille peut accéder à la chambre 3.Advantageously, the arrangement according to the invention makes it possible to produce a "multifaceted" puncture zone 4, that is to say to divide or fractionate said puncture zone into a plurality of elementary blocks through which a needle can access in room 3.
A ce titre, il est remarquable que le premier et le second bloc élémentaire forment deux zones d'accès voisines à une seule et même chambre 3.In this respect, it is remarkable that the first and second elementary blocks form two adjacent access zones to one and the same chamber 3.
Ainsi, il est avantageusement possible de bâtir une zone de ponction particulièrement étendue par rapport à la surface extérieure globale du site implantable 1 , tout en limitant les dimensions, des blocs élémentaires 5, 105 constitutifs de ladite zone de ponction plurale 4 et donc la fragilité ou la souplesse intrinsèque de cette dernière.Thus, it is advantageously possible to construct a particularly extensive puncture zone with respect to the overall external surface of the implantable site 1, while limiting the dimensions, elementary blocks 5, 105 constituting said plural puncture zone 4 and therefore the fragility or the intrinsic flexibility of the latter.
Tel que cela sera détaillé ci-après, il est notamment envisageable de réduire l'épaisseur des blocs élémentaires formant septums, et par conséquent l'encombrement du site 1 , tout en préservant une rigidité structurelle suffisante de la zone de ponction 4 et du site 1 dans son ensemble.As will be detailed below, it is in particular conceivable to reduce the thickness of the elementary blocks forming septa, and therefore the size of the site 1, while preserving sufficient structural rigidity of the puncture zone 4 and the site 1 as a whole.
Bien entendu, la forme desdits blocs élémentaires conformes à l'invention n'est nullement limitée.Of course, the shape of said elementary blocks according to the invention is not limited.
A titre d'exemple, un bloc élémentaire 5, 105 pourra se présenter globalement sous forme d'un polyèdre, de préférence à six faces, tels qu'un parallélépipède rectangle ou un cube, ou encore sous forme d'une portion de couronne annulaire de section transverse circulaire, elliptique, polygonale, carrée, etc. En particulier, tel que cela est représenté sur les figures 3, 4, 7 et 8, les blocs élémentaires pourront former des portions de couronne annulaire présentant des faces externes et internes sensiblement rectangulaires et bombées.By way of example, an elementary block 5, 105 may be generally in the form of a polyhedron, preferably with six faces, such as a rectangular parallelepiped or a cube, or in the form of an annular crown portion circular, elliptical, polygonal, square, etc. In particular, as shown in FIGS. 3, 4, 7 and 8, the elementary blocks may form annular ring portions having substantially rectangular and curved external and internal faces.
Par commodité de description et sans que cela ne constitue une limitation de l'invention, on considérera, en référence à l'exemple simplifié illustré sur la figure 9, que chaque bloc élémentaire 5 est plein et présente six faces, en l'occurrence une face interne 51 « avant », une face externe 5E « arrière », et une face latérale 5L formée par un ensemble de quatre faces, de préférence planes, désignées par convention comme « faces latérale gauche » 5LG, « face latérale droite » 5LD, « face latérale supérieure » 5LS et « face latérale inférieure » 5Ll.For convenience of description and without this constituting a limitation of the invention, it will be considered, with reference to the simplified example illustrated in FIG. 9, that each elementary block 5 is solid and has six faces, in this case one inner face 51 "front", an outer face 5E "rear", and a side face 5L formed by a set of four faces, preferably planar, designated conventionally as "left side faces" 5LG, "right side face" 5LD, "Upper side face" 5LS and "lower side face" 5Ll.
Au sens de l'invention, on pourra « disposer côte à côte » le premier bloc élémentaire 5 et le second bloc élémentaire 105 soit en les superposant, par exemple en plaçant la face latérale inférieure 105Ll du second bloc 105 en vis-à-vis de la face latérale supérieure 5LS du premier bloc 5, soit en les juxtaposant, par exemple en plaçant la face latérale gauche 105LG du second bloc 105 en regard de la face latérale droite 5LD du premier bloc.Within the meaning of the invention, it will be possible to "arrange side by side" the first elementary block 5 and the second elementary block 105 either by superimposing them, for example by placing the lower lateral face 105L1 of the second block 105 in vis-à-vis of the upper lateral face 5LS of the first block 5, or by juxtaposing them, for example by placing the left side face 105LG of the second block 105 facing the right side face 5LD of the first block.
Bien entendu, selon une autre variante de réalisation non représentée, les blocs élémentaires pourront présenter une forme de révolution sensiblement cylindrique ou tronconique, leurs faces interne et externe correspondant aux base de la forme de révolution et leurs faces latérales correspondant alors sensiblement à une couronne continue.Of course, according to another variant embodiment not shown, the elementary blocks may have a substantially cylindrical or frustoconical shape of revolution, their inner and outer faces corresponding to the base of the form of revolution and their lateral faces then corresponding substantially to a continuous ring .
En d'autres termes, la face latérale 5L correspondra à la réunion des chants du bloc élémentaire considéré, que celui-ci présente un contour formant une ligne continue ou brisée. En outre, bien qu'il soit envisageable de combiner entre eux plusieurs formats de blocs élémentaires, lesdits blocs élémentaires 5, 105 seront de préférence sensiblement identiques dans leurs formes, leurs dimensions et leur composition.In other words, the lateral face 5L will correspond to the meeting of the songs of the elementary block considered, that it has a contour forming a continuous or broken line. In addition, although it is conceivable to combine several formats of elementary blocks together, said elementary blocks 5, 105 will preferably be substantially identical in their shapes, their dimensions and their composition.
Ainsi, on peut réaliser la zone de ponction 4 à l'aide d'éléments standard interchangeables, ce qui permet de limiter considérablement le taux de rebut, de faciliter l'assemblage, et globalement de réduire sensiblement le coût de fabrication du dispositif 1.Thus, it is possible to perform the puncture zone 4 by means of standard interchangeable elements, which makes it possible to considerably limit the scrap rate, to facilitate assembly, and overall to substantially reduce the manufacturing cost of the device 1.
Bien qu'il soit envisageable de décaler un bloc élémentaire par rapport à un autre, par exemple de telle sorte que la face externe d'un bloc élémentaire soit rentrante ou saillante par rapport à la ou les face(s) externe(s) du ou des blocs élémentaires voisins, la face externe 105E du second bloc élémentaire 105 sera de préférence disposée sensiblement dans le prolongement de la face externe 5E du premier bloc élémentaire 5.Although it is conceivable to shift an elementary block relative to another, for example so that the outer face of an elementary block is reentrant or projecting relative to the outer face (s) of the or neighboring elementary blocks, the external face 105E of the second elementary block 105 will preferably be disposed substantially in the extension of the outer face 5E of the first elementary block 5.
Ainsi, le site 1 présente avantageusement une surface extérieure sensiblement sans aspérité, qui le rend particulièrement atraumatique et qui offre peu de prise à la gangue tissulaire.Thus, the site 1 advantageously has an outer surface substantially without asperity, which makes it particularly atraumatic and offers little grip tissue gangue.
De préférence, la portion de face latérale 5L du premier bloc élémentaire 5 et la portion de face latérale 105L du second bloc élémentaire 105 située en vis-à-vis de celle-ci présentent des formes sensiblement conjuguées et s'étendent sensiblement parallèlement l'une à l'autre.Preferably, the lateral face portion 5L of the first elementary block 5 and the lateral face portion 105L of the second elementary block 105 situated opposite it have substantially conjugate shapes and extend substantially parallel to each other. one to another.
En outre, l'alignement des faces externes et la similitude de dimensions des blocs permet avantageusement d'obtenir un recouvrement mutuel quasi total des portions de surfaces latérales respectives de deux blocs élémentaires voisins, ce qui optimise l'étanchéité et la stabilité de l'ensemble ainsi formé. Bien entendu, dans le cas où les faces latérales présentent une géométrie incurvée, et notamment circulaire, elles peuvent être disposées sensiblement tangentiellement l'une à l'autre sans sortir du cadre de l'invention.In addition, the alignment of the external faces and the similarity of the dimensions of the blocks advantageously makes it possible to obtain a virtually total mutual overlap of the respective lateral surface portions of two neighboring elementary blocks, which optimizes the tightness and the stability of the together so formed. Of course, in the case where the lateral faces have a curved geometry, and in particular circular, they can be arranged substantially tangentially to each other without departing from the scope of the invention.
Selon une première variante de réalisation qui correspond aux figures 1 à 3, le premier bloc élémentaire 5 et le second bloc élémentaire 105 sont immédiatement juxtaposés de telle sorte que leurs faces latérales respectives 5L, 105L se trouvent au contact direct l'une de l'autre.According to a first variant embodiment which corresponds to FIGS. 1 to 3, the first elementary block 5 and the second elementary block 105 are immediately juxtaposed so that their respective lateral faces 5L, 105L are in direct contact with one of the other.
En faisant se toucher bord à bord des blocs élémentaires adjacents, il est possible de réaliser une structure étanche à la fois simple et compacte.By touching adjacent elementary blocks adjacent to each other, it is possible to produce a tight and simple structure that is compact.
Toutefois, de façon préférentielle, le premier bloc élémentaire 5 et le second bloc élémentaire 105 sont séparés l'un de l'autre, au moins partiellement, par une cloison anti-perforation 10 interposée entre leurs portions de faces latérales 5L, 105L situées en vis-à-vis l'une de l'autre, ladite cloison 10 étant conçue pour faire obstacle à la pénétration transverse d'une aiguille.However, preferably, the first elementary block 5 and the second elementary block 105 are separated from each other, at least partially, by an anti-perforation partition 10 interposed between their lateral face portions 5L, 105L located in vis-à-vis one another, said partition 10 being designed to prevent the transverse penetration of a needle.
En d'autres termes, la cloison anti-perforation 10 forme un organe, de préférence rigide, qui est résistant à la perforation par une aiguille et qui se situe à l'interface entre deux blocs élémentaires voisins, de manière à empêcher une aiguille abordant sensiblement tangentiellement le boîtier 2 de traverser successivement le premier bloc puis le second bloc sans pour autant pénétrer à l'intérieur de la chambre 3.In other words, the anti-perforation partition 10 forms a member, preferably rigid, which is resistant to perforation by a needle and which is located at the interface between two neighboring elementary blocks, so as to prevent a needle from approaching. substantially tangentially the housing 2 to pass successively the first block and the second block without penetrating inside the chamber 3.
Avantageusement, cet agencement permet d'éviter un piquage tangentiel accidentel selon lequel l'aiguille resterait bloquée dans le septum, ou traverserait ledit septum de part en part pour ressortir dans les tissus, ce qui permet de garantir une utilisation à la fois sûre et fiable du dispositif 1 conforme à l'invention. En effet, si le praticien ressent une résistance à la pénétration de l'aiguille immédiatement après avoir piqué le site 1 , il en déduit qu'il bute contre une cloison 10 et peut alors corriger ou reprendre son geste de piquage de manière à être certain que l'extrémité de l'aiguille a effectivement pénétré dans la chambre et atteint une profondeur fonctionnelle compatible avec le transfert de fluide.Advantageously, this arrangement makes it possible to avoid accidental tangential tapping according to which the needle remains blocked in the septum, or would pass through said septum from one side to the other in order to emerge into the tissues, which makes it possible to guarantee a use that is both safe and reliable. of the device 1 according to the invention. Indeed, if the practitioner feels a resistance to the penetration of the needle immediately after stitching the site 1, he deduces that it abuts against a partition 10 and can then correct or resume its stitching gesture so as to be certain that the end of the needle has actually penetrated into the chamber and reaches a functional depth compatible with the fluid transfer.
De préférence, tel que cela est illustré sur les figures 4, 7 et 8, la cloison antiperforation 10 est formée par une plaque, de préférence sensiblement plane, dont l'épaisseur est préférentiellement comprise sensiblement entre 0,3 mm et 2 mm, et de façon particulièrement préférentielle, comprise entre 0,5 et 1 ,5 mm.Preferably, as is illustrated in FIGS. 4, 7 and 8, the antiperforation partition 10 is formed by a plate, preferably substantially flat, the thickness of which is preferably substantially between 0.3 mm and 2 mm, and in a particularly preferred manner, between 0.5 and 1.5 mm.
Ainsi, la cloison 10 définit une distance d'écartement minimale entre le premier et le second bloc élémentaire 5, 105, qui correspond sensiblement à la longueur d'un segment fictif normal aux parois latérales 5L, 105L correspondantes et joignant les points respectifs desdites parois latérales les plus rapprochés l'un de l'autre.Thus, the partition 10 defines a minimum separation distance between the first and the second elementary block 5, 105, which corresponds substantially to the length of a notional segment normal to the corresponding side walls 5L, 105L and joining the respective points of said walls. sideways closest to each other.
Par ailleurs, le premier bloc élémentaire 5 et le second bloc élémentaire 105 forment de préférence une zone de ponction 4 globalement convexe par rapport à l'extérieur du dispositif 1.Furthermore, the first elementary block 5 and the second elementary block 105 preferably form a puncture zone 4 generally convex relative to the outside of the device 1.
Au sens de l'invention, cette convexité peut être obtenue soit au moyen de blocs élémentaires 5, 105 présentant une forme incurvée dont Ie bombé est orienté vers l'extérieur, soit au moyen de blocs élémentaires polyédriques logés dans des parois du boîtier distinctes et sécantes, soit encore au moyen de blocs élémentaires polyédriques présentant des faces latérales, notamment gauche et/ou droite, inclinées par rapport aux face interne 51 et/ou externe 5E, de sorte que la disposition desdites faces latérales parallèlement l'une à l'autre conduise à la formation d'une arête saillante à l'interface entre les faces externes des blocs voisins.Within the meaning of the invention, this convexity can be obtained either by means of elementary blocks 5, 105 having a curved shape with the curvature oriented outwards, or by means of polyhedral elementary blocks housed in separate housing walls and intersecting, or else by means of polyhedral elementary blocks having lateral faces, in particular left and / or right, inclined with respect to the inner face 51 and / or outer face 5E, so that the disposition of said lateral faces parallel to one another leads to the formation of a projecting edge at the interface between the outer faces of neighboring blocks.
De préférence, on emploiera des blocs élémentaires aux formes incurvées ou arrondies, et de façon particulièrement préférentielle des blocs élémentaires dont les faces externes 5E, 105E présentent une continuité de courbure afin d'éviter les transitions abruptes entre lesdits blocs élémentaires.Preferably, elementary blocks with curved or rounded shapes will be used, and particularly preferably elementary blocks whose external faces 5E, 105E have continuity of curvature in order to avoid abrupt transitions between said elementary blocks.
Par ailleurs, l'épaisseur des blocs élémentaires 5, 105 mesurée entre la face externe 5E, 105E et la face interne 51, 1051 sera de préférence sensiblement constante, de telle sorte que la convexité de la zone de ponction 4 se traduit par une convexité sensiblement analogue de la chambre 3 elle-même.Furthermore, the thickness of the elementary blocks 5, 105 measured between the outer face 5E, 105E and the inner face 51, 1051 will preferably be substantially constant, so that the convexity of the puncture zone 4 results in a convexity substantially similar to the chamber 3 itself.
Avantageusement, un tel agencement permet de maximiser le volume utile de ladite chambre 3, de fournir un accès à cette dernière selon de nombreuses directions d'approche de l'aiguille, et ainsi d'optimiser la compacité et l'accessibilité du site 1.Advantageously, such an arrangement makes it possible to maximize the useful volume of said chamber 3, to provide access thereto according to numerous directions of approach of the needle, and thus to optimize the compactness and accessibility of the site 1.
De préférence, tel que cela est illustré sur les figures, la chambre 3, et plus globalement le boîtier 2, présente une géométrie sensiblement cylindrique générée par une surface de base 11 selon un axe générateur (XX').Preferably, as shown in the figures, the chamber 3, and more generally the housing 2, has a substantially cylindrical geometry generated by a base surface 11 along a generating axis (XX ').
Par « forme cylindrique », on désigne de manière globale toute forme obtenue lorsqu'une surface de base 11 quelconque balaye une courbe prédéterminée quelconque formant ledit axe générateur (XX')."Cylindrical shape" denotes globally any shape obtained when any base surface 11 scans any predetermined curve forming said generator axis (XX ').
De préférence, l'axe générateur (XX') est toutefois rectiligne. Par pure commodité de description, on considère que ledit axe générateur est vertical (étant entendu qu'il sera de préférence orienté sensiblement parallèlement à la surface de la peau une fois le site 1 implanté). La surface de base 11 peut avantageusement être formée par un disque, tel que cela est représenté sur les variantes illustrées aux figures.Preferably, the generating axis (XX ') is, however, rectilinear. For the sake of convenience of description, it is considered that said generator axis is vertical (it being understood that it will preferably be oriented substantially parallel to the surface of the skin once the site 1 implanted). The base surface 11 may advantageously be formed by a disk, as shown in the variants illustrated in the figures.
Toutefois, cette forme n'est nullement limitative, la surface de base pouvant également être formée par une portion de disque, tel qu'un secteur angulaire correspondant à la portion comprise entre 2 rayons distincts et l'arc de cercle joignant les extrémités desdits rayons, un croissant, un demi-disque, ou encore un quartier.However, this form is in no way limiting, the base surface may also be formed by a disk portion, such as an angular sector corresponding to the portion between 2 distinct radii and the arc of the circle joining the ends of said radii , a crescent, a half-disc, or a neighborhood.
La surface de base 11 peut également correspondre à une surface elliptique ou ellipsoïde, ou encore une surface polygonale telle qu'un triangle, un rectangle, un carré, un hexagone ou tout autre type de polygone, de préférence convexe et régulier.The base surface 11 may also correspond to an elliptical or ellipsoidal surface, or a polygonal surface such as a triangle, a rectangle, a square, a hexagon or any other type of polygon, preferably convex and regular.
Selon une variante de réalisation préférentielle, la surface de base 11 présente des dimensions sensiblement constantes le long de l'axe générateur (XX'), et le boîtier est obturé à chacune de ses extrémités par un flasque terminal 12, 13, de préférence résistant à la perforation.According to a preferred embodiment, the base surface 11 has substantially constant dimensions along the generator axis (XX '), and the housing is closed at each of its ends by a terminal flange 12, 13, preferably resistant to the perforation.
Bien entendu, la surface de base 11 peut également présenter des dimensions variables le long de l'axe générateur (XX'), c'est-à-dire que le site 1 présente une section transversale, considérée dans un plan normal à l'axe générateur (XX'), de taille variable selon Ie point dudit axe générateur (XX') ou l'on se place, le boîtier 2 pouvant ainsi se présenter sous une forme ovoïde, piriforme, sphérique, etc., sans sortir du cadre de l'invention.Of course, the base surface 11 may also have variable dimensions along the generator axis (XX '), that is to say that the site 1 has a cross section, considered in a plane normal to the generator axis (XX '), of variable size along the point of said generator axis (XX') where it is placed, the housing 2 can thus be in an ovoid, pear-shaped, spherical, etc., without departing from the frame of the invention.
Selon une variante de réalisation non représentée, le boîtier 2 peut également se présenter sous la forme d'un polyèdre, tel qu'un cube ou un parallélépipède rectangle, les arêtes étant alors de préférence arrondies par 5According to an alternative embodiment not shown, the housing 2 can also be in the form of a polyhedron, such as a cube or a rectangular parallelepiped, the edges then being preferably rounded by 5
des congés de raccordement afin de conserver au site un caractère sensiblement atraumatique.connection holidays in order to keep the site a substantially atraumatic character.
Avantageusement, une telle forme polyédrique globale permet de faciliter l'assemblage du site 1 mais également de bénéficier de surfaces d'appui particulièrement stable contre les tissus une fois ledit site implanté.Advantageously, such a global polyhedron shape makes it easier to assemble the site 1 but also to benefit from particularly stable support surfaces against the tissues once said implanted site.
De façon préférentielle, au moins l'un des flasques terminaux 13 est pourvu d'un embout de raccordement 14 formant un conduit permettant de relier un orifice de sortie débouchant dans la chambre 3 à un cathéter (non représenté).Preferably, at least one of the end flanges 13 is provided with a connecting piece 14 forming a conduit for connecting an outlet opening opening in the chamber 3 to a catheter (not shown).
De préférence, l'organe de raccordement 14 et l'axe générateur (XX') sont coaxiaux.Preferably, the connecting member 14 and the generating axis (XX ') are coaxial.
De préférence, la zone de ponction 4 s'étend au moins en partie, de façon particulièrement préférentielle en majorité (soit à plus de 50%), voire exclusivement sur la paroi latérale du boîtier 2 cylindrique.Preferably, the puncture zone 4 extends at least in part, particularly preferably (more than 50%), or even exclusively on the side wall of the cylindrical housing 2.
En outre, de façon préférentielle, la couverture angulaire de la zone de ponction 4, considérée dans un plan normal à l'axe générateur (XX'), est supérieure ou égale à 90°, de préférence supérieure ou égale à 180°, et de façon particulièrement préférentielle supérieure ou égale à 300°, voire sensiblement égale à 360°.In addition, preferably, the angular coverage of the puncture zone 4, considered in a plane normal to the generating axis (XX '), is greater than or equal to 90 °, preferably greater than or equal to 180 °, and particularly preferably greater than or equal to 300 °, or substantially equal to 360 °.
En d'autres termes, la chambre 3 est effectivement accessible, c'est-à-dire la paroi du boîtier 2 transperçable, sur au moins un quart, de préférence la moitié, et de façon encore plus préférentielle sur la quasi totalité du pourtour latéral du boîtier. Avantageusement, la zone de ponction 4, et plus globalement le boîtier 2 présentera une géométrie globalement invariante par rotation d'ordre 2, 3, 4 et/ou 6 autour de l'axe générateur (XX'), c'est-à-dire invariante par rotation de 180°, 120°, 90° ou 60°, notamment dans le cas d'un boîtier polyédrique, voire une géométrie de révolution totalement invariante par rotation, qui rend le dispositif 1 quasiment insensible à un retournement sur lui-même, puisque ce dernier conserve sa fonctionnalité et son accessibilité dans de nombreuses configurations angulaires par rapport à la surface de la peau.In other words, the chamber 3 is effectively accessible, that is to say the wall of the casing 2 pierceable, on at least a quarter, preferably half, and even more preferably on almost the entire circumference lateral of the case. Advantageously, the puncture zone 4, and more generally the housing 2 will have a generally invariant geometry by rotation of order 2, 3, 4 and / or 6 around the generator axis (XX '), that is to say to say invariant by rotation of 180 °, 120 °, 90 ° or 60 °, in particular in the case of a polyhedral casing, or even a geometry of revolution totally invariant by rotation, which makes the device 1 almost insensitive to a reversal on itself. same, since it retains its functionality and accessibility in many angular configurations relative to the skin surface.
La zone de ponction 4 peut comporter à cet effet une pluralité de blocs élémentaires 5, 105, 205, 305, 405, 505, 605, 705 disposés côte à côte de manière à former une couche annulaire 20 dont le contour correspond sensiblement à celui de la surface de base 11.The puncture zone 4 may comprise for this purpose a plurality of elementary blocks 5, 105, 205, 305, 405, 505, 605, 705 arranged side by side so as to form an annular layer 20 whose contour substantially corresponds to that of the base area 11.
Avantageusement, chaque bloc élémentaire couvre une portion angulaire (mesurée autour de l'axe générateur (XX') dans un plan normal à ce dernier) qui correspond à une subdivision radiale de la couverture angulaire totale de la zone de ponction 4.Advantageously, each elementary block covers an angular portion (measured around the generator axis (XX ') in a plane normal to the latter) which corresponds to a radial subdivision of the total angular coverage of the puncture zone 4.
Bien entendu, l'homme du métier sera à même d'apprécier le nombre et la dimension des blocs élémentaires en fonction de l'étendue du boîtier, et plus précisément du périmètre de la couche annulaire 20.Of course, those skilled in the art will be able to appreciate the number and size of the elementary blocks as a function of the extent of the housing, and more precisely of the perimeter of the annular layer 20.
Ainsi, une couche annulaire 20 pourra comprendre deux blocs élémentaires, ou trois blocs élémentaires, ou quatre blocs élémentaires (figures 5, 6, 7 et 8), ou six blocs élémentaires, ou encore huit blocs élémentaires, voire plus, disposés en enfilade pour former une sorte de mur constitutif de ladite couche 20.Thus, an annular layer 20 may comprise two elementary blocks, or three elementary blocks, or four elementary blocks (FIGS. 5, 6, 7 and 8), or six elementary blocks, or eight or more elementary blocks arranged in a row to forming a kind of constituent wall of said layer 20.
Bien entendu, de manière analogue à ce qui a été décrit précédemment, il est envisageable de disposer une cloison anti-perforation 10 entre chaque paire de blocs élémentaires voisins au sein d'une même couche annulaire 20, tel que cela est illustré sur les figures 4, 7 ou 10.Of course, similarly to what has been described above, it is conceivable to have an anti-perforation partition 10 between each pair of neighboring elementary blocks within the same annular layer 20, as shown in Figures 4, 7 or 10.
Selon une disposition constructive préférentielle, la (ou les) cloison(s) antiperforation 10 se prolonge(nt) dans Ia chambre 3 de manière à former un écran anti-transpercement 21 , tel que cela est représenté sur la figure 7, ledit écran 21 étant conçu pour empêcher une aiguille de traverser Ie boîtier 2 de part en part. En particulier, plusieurs cloisons 10 peuvent se rejoindre sensiblement au centre de la chambre pour former un croisillon ou une étoile.According to a preferred constructive arrangement, the (or) antiperforation partition (s) 10 extends (s) in the chamber 3 so as to form an anti-piercing screen 21, as shown in Figure 7, said screen 21 being designed to prevent a needle from passing through the housing 2 from one side to the other. In particular, several partitions 10 can meet substantially in the center of the chamber to form a spider or a star.
Ainsi, le praticien est assuré que l'aiguille se trouve effectivement dans la chambre 3 lorsqu'il cherche à réaliser le transfert de fluide.Thus, the practitioner is assured that the needle is actually in the chamber 3 when it seeks to achieve the transfer of fluid.
D'autre part, les blocs élémentaires 5, 105 présentent de préférence des faces latérales d'appui 5L, 105L et plus particulièrement des faces latérales gauches 5LG, 105LG et droite 5LD, 105LD qui convergent vers l'intérieur de la chambre, et de préférence qui s'étendent selon des plans sécants dont l'intersection coïncide avec l'axe générateur (XX'), de telle sorte que lesdits blocs élémentaires viennent en appui autobloquant contre les cloisons 10 (ou les uns contre les autres) dans le sens de pénétration de l'aiguille.On the other hand, the elementary blocks 5, 105 preferably have lateral bearing faces 5L, 105L and more particularly left side faces 5LG, 105LG and right 5LD, 105LD which converge towards the inside of the chamber, and preferably extending in intersecting planes whose intersection coincides with the generating axis (XX '), so that said elementary blocks come into self-locking support against the partitions 10 (or against each other) in the direction penetration of the needle.
Ainsi, les blocs élémentaires peuvent former des sortes d'arcs de décharge qui opposent spontanément une résistance à l'enfoncement lorsqu'une une contrainte de pénétration radiale centripète est exercée sur leur face externe 5E, 105E et dirigée vers l'intérieur de la chambre 3, et plus particulièrement vers l'axe générateur (XX').Thus, the elementary blocks can form a kind of discharge arcs which spontaneously oppose a resistance to depression when a centripetal radial penetration stress is exerted on their outer face 5E, 105E and directed towards the interior of the chamber. 3, and more particularly towards the generator axis (XX ').
D'autre part, le dispositif 1 peut avantageusement comporter une pluralité de couches annulaires 20, 2OA, 2OB superposées selon la direction de l'axe générateur (XX'). Ainsi, le site 1 conforme à l'invention peut présenter une pluralité de blocs élémentaires empilés les uns par rapport aux autres, de sorte à former une structure matricielle délimitant un contour fermé de la chambre 3.On the other hand, the device 1 may advantageously comprise a plurality of annular layers 20, 2OA, 2OB superimposed in the direction of the generator axis (XX '). Thus, the site 1 according to the invention may have a plurality of elementary blocks stacked with respect to each other, so as to form a matrix structure delimiting a closed contour of the chamber 3.
Ainsi, la zone de ponction 4 peut présenter avantageusement une structure matricielle comportant au moins deux lignes (les rangées horizontales correspondant aux couches annulaires) et au moins deux colonnes (les rangées verticales de blocs appartenant aux couches annulaires successives), chaque élément de ladite matrice étant formé par un bloc élémentaire.Thus, the puncture zone 4 may advantageously have a matrix structure comprising at least two lines (the horizontal rows corresponding to the annular layers) and at least two columns (the vertical rows of blocks belonging to the successive annular layers), each element of said matrix being formed by an elementary block.
Plus globalement, Ia zone de ponction 4 conforme à l'invention est de préférence modulaire et scindée en une pluralité de blocs élémentaires, en l'occurrence au moins trois, séparés les uns des autres selon au moins deux surfaces d'interruption sécantes, de préférence sensiblement planes et orthogonales. De préférence, lesdits blocs sont disposés côte à côte selon deux directions distinctes de l'espace.More generally, the puncture zone 4 according to the invention is preferably modular and split into a plurality of elementary blocks, in this case at least three, separated from each other in at least two intersecting interruption surfaces, preferably substantially planar and orthogonal. Preferably, said blocks are arranged side by side in two distinct directions of space.
En particulier, la zone de ponction 4 possède de préférence un premier niveau (ou première couche) comportant au moins un premier et un second bloc élémentaire disposés côte à côte et séparés au moins en partie, et de préférence en totalité, par une première zone d'interruption s'étendant sensiblement selon un premier plan, en l'occurrence un plan vertical contenant l'axe générateur (XX'), et au moins un second niveau comportant au moins un troisième bloc élémentaire qui chevauche au moins en partie le premier et/ou le second bloc élémentaire et qui est séparé au moins en partie, et de préférence en totalité, de celui-ci, ou de ceux-ci, par une seconde zone d'interruption s'étendant sensiblement selon un second plan sécant, et en l'occurrence orthogonal, au premier plan. Par ailleurs, les différentes couches annulaires 20, 2OA, 2OB peuvent être séparées les unes des autres par des flasques intermédiaires 21 , 22, de préférence rigide et résistants à la perforation.In particular, the puncture zone 4 preferably has a first level (or first layer) comprising at least a first and a second elementary block arranged side by side and separated at least in part, and preferably entirely, by a first zone substantially extending in a first plane, in this case a vertical plane containing the generator axis (XX '), and at least a second level comprising at least a third elementary block which overlaps at least partially the first and / or the second elementary block and which is separated at least in part, and preferably totally, from it, or thereof, by a second interruption zone extending substantially along a second secant plane, and in this case orthogonal, in the foreground. Furthermore, the different annular layers 20, 20A, 20B may be separated from each other by intermediate flanges 21, 22, preferably rigid and resistant to perforation.
De préférence, tel que cela est illustré sur la figure 2, lesdits flasques intermédiaires 21 , 22 sont formés par des rondelles disposées sensiblement normalement à l'axe générateur (XX').Preferably, as shown in Figure 2, said intermediate flanges 21, 22 are formed by washers disposed substantially normally to the generator axis (XX ').
Ainsi, la zone de ponction 4 peut être cloisonnée à la fois radialement, par les cloisons 10, et transversalement par les flasques intermédiaires 21 , 22, l'ensemble formant ainsi une structure alvéolée.Thus, the puncture zone 4 can be partitioned both radially, by the partitions 10, and transversely by the intermediate flanges 21, 22, the assembly thus forming a honeycomb structure.
Les cloisons 10 peuvent en outre être venues de matière avec un ou plusieurs flasques intermédiaires 21 , 22.The partitions 10 may also be integral with one or more intermediate flanges 21, 22.
De façon préférentielle, les blocs élémentaires 5, 105, 205, 305, 405, 505, 605, 705 sont tous identiques, dans leurs formats et leurs composition.Preferably, the elementary blocks 5, 105, 205, 305, 405, 505, 605, 705 are all identical, in their formats and their compositions.
Selon une autre variante de réalisation non représentée, le premier et le second bloc élémentaire sont formés chacun par un segment annulaire complet, de préférence obtenu par balayage d'une section transversale rectangulaire ou carrée autour de l'axe générateur (XX'), lesdits segments annulaires étant simplement empilés l'un au-dessus de l'autre, et éventuellement séparés par un flasque intermédiaire.According to another variant of embodiment not shown, the first and the second elementary block are each formed by a complete annular segment, preferably obtained by scanning a rectangular or square cross section around the generator axis (XX '), said annular segments being simply stacked one above the other, and optionally separated by an intermediate flange.
Selon une variante de réalisation illustrée à la figure 7, le dispositif comprend un châssis alvéolé modulaire 30 lequel comporte plusieurs piliers 31, de préférence reliés par des traverses 32 indépendantes, lesdits piliers 31 formant, de préférence en combinaison avec lesdites traverses 32, des montures dans lesquelles les blocs élémentaires 5, 105, 205, 305 sont enchâssés. Une telle structure modulaire est avantageusement évolutive, et permet au besoin de monter autant de rangées successives de blocs élémentaires qu'il est nécessaire pour obtenir un boîtier de longueur (en l'occurrence de hauteur) totale librement choisie par le fabricant.According to an alternative embodiment illustrated in FIG. 7, the device comprises a modular honeycomb frame 30 which comprises several pillars 31, preferably connected by independent cross members 32, said pillars 31 forming, preferably in combination with said sleepers 32, frames in which the elementary blocks 5, 105, 205, 305 are embedded. Such a modular structure is advantageously scalable, and allows the need to mount as many successive rows of elementary blocks as is necessary to obtain a package of length (in this case of height) total freely chosen by the manufacturer.
Avantageusement, les piliers 31 , de préférence rigides, joignent entre eux les flasques terminaux 12, 13 de manière à rigidifier le site 1.Advantageously, the pillars 31, preferably rigid, join together the end flanges 12, 13 so as to stiffen the site 1.
Lesdits piliers 31 peuvent en outre avantageusement être venus de matière avec les cloisons anti-perforations 10.Said pillars 31 may advantageously be integral with the anti-perforation partitions 10.
Par ailleurs, les traverses 32 peuvent être soit monoblocs, c'est-à-dire former, entre deux étages correspondant à une rangée horizontale de blocs élémentaires (ou à une couche annulaire 20), un plateau d'un seul tenant, tel que cela est illustré sur la figure 8, ou encore former des éléments indépendants de type tablettes correspondant à des subdivisions radiales de plaque annulaire, par exemple en quart d'anneau sur la figure 7.Furthermore, the cross members 32 may be either one-piece, that is to say, form, between two stages corresponding to a horizontal row of elementary blocks (or to an annular layer 20), a plate in one piece, such that this is illustrated in FIG. 8, or else forming independent shelf-type elements corresponding to radial subdivisions of annular plate, for example quarter-ring in FIG. 7.
Avantageusement, lesdites traverses 32 forment Ie ou les flasques intermédiaires.Advantageously, said sleepers 32 form Ie or the intermediate flanges.
De préférence, les piliers 31 et/ou les traverses 32 sont pourvus d'empreintes 33 délimitées par des rebords d'arrêt 34, lesdites empreintes 33 étant conçues pour accueillir et maintenir en position, notamment à distance radiale fixe par rapport à l'axe générateur (XX'), les blocs élémentaires.Preferably, the pillars 31 and / or the cross members 32 are provided with indentations 33 delimited by stop edges 34, said indentations 33 being designed to receive and hold in position, in particular at a fixed radial distance with respect to the axis. generator (XX '), the elementary blocks.
Avantageusement, tel que cela est illustré sur la figure 7, les empreintes 33 ménagées dans les piliers 31 peuvent être formées par des rainures circulaires débouchantes centrées sur l'axe générateur (XX'), tandis que les traverses 32 sont pourvues de languettes 35 de forme conjuguée permettant l'insertion et le libre débattement axial, le long dudit axe générateur (XX'), desdites traverses par rapport aux piliers 31 tout en assurant le blocage radial desdites traverses 32.Advantageously, as shown in FIG. 7, the indentations 33 formed in the pillars 31 may be formed by open circular grooves centered on the generating axis (XX '), whereas the crosspieces 32 are provided with tabs 35 of conjugate form allowing insertion and free axial displacement, along said generator axis (XX '), said sleepers relative to the pillars 31 while ensuring the radial locking of said sleepers 32.
Ainsi, de façon particulièrement avantageuse, il est possible d'assembler facilement le boîtier 2 en positionnant tout d'abord les piliers 31 et en les fixant dans un flasque terminal 12, 13, puis en élevant entre chaque paire de piliers voisins une zone de ponction constituée par une alternance de blocs élémentaires 5 et de traverses 32 empilées les uns au-dessus des autres.Thus, particularly advantageously, it is possible to easily assemble the housing 2 by first positioning the pillars 31 and fixing them in a terminal flange 12, 13, then raising between each pair of adjacent pillars a zone of puncture constituted by alternating elementary blocks 5 and sleepers 32 stacked one above the other.
Selon une autre variante de réalisation, le premier et/ou le second bloc élémentaire 5, 105 sont pourvus d'au moins un tenon 40 et/ou d'au moins une mortaise 41 conçus pour permettre leur fixation entre eux ou à un élément fixe du boîtier.According to another variant embodiment, the first and / or second elementary block 5, 105 are provided with at least one tenon 40 and / or at least one mortise 41 designed to allow their attachment to one another or to a fixed element of the case.
Plus particulièrement, tel que cela est illustré sur les figures 2, 3 et 4, chaque bloc élémentaire peut être pourvu de deux tenons 40 faisant saillie respectivement sur ses faces latérale supérieure 5LS et latérale inférieure 5Ll de manière à venir se loger dans une mortaise 41 conjuguée creusée dans le flasque intermédiaire 21 , 22 ou dans le flasque terminal 12, 13 correspondant, de manière à bloquer radialement en position ledit bloc élémentaire.More particularly, as illustrated in Figures 2, 3 and 4, each elementary block may be provided with two pins 40 projecting respectively on its upper lateral surfaces 5LS and lower lateral 5Ll so as to be housed in a mortise 41 conjugate dug in the intermediate flange 21, 22 or in the corresponding end flange 12, 13, so as to block radially position said elementary block.
Avantageusement, le système de tenons et mortaises confère aux blocs élémentaires un caractère autobloquant et auto-centreur qui facilite l'assemblage et améliore la robustesse structurelle du site 1.Advantageously, the system of tenons and mortises gives the elementary blocks a self-locking and self-centering character which facilitates the assembly and improves the structural robustness of the site 1.
Tel que cela est illustré sur les figures 1 à 7, le premier et le second bloc élémentaire 5, 105 peuvent être intrinsèquement distincts l'un de l'autre, c'est-à-dire constituer deux entités physiquement et cinématiquement indépendantes, que l'on peut rapporter indépendamment l'une de l'autre sur le site 1 lors du montage. Toutefois, selon une variante de réalisation correspondant à la figure 8, le premier et le second bloc élémentaire 5, 105 sont reliés entre eux par une bande de jonction 50.As illustrated in FIGS. 1 to 7, the first and the second elementary blocks 5, 105 may be intrinsically distinct from each other, that is to say constitute two physically and kinematically independent entities, that we can report independently of each other on site 1 during assembly. However, according to an alternative embodiment corresponding to FIG. 8, the first and the second elementary blocks 5, 105 are interconnected by a connecting strip 50.
De préférence, ladite bande de jonction 50 se présente sous forme d'un ruban dont la hauteur, en l'occurrence mesurée parallèlement à l'axe générateur (XX'), est sensiblement égale à celle des faces externes 5E, 105E, et dont l'épaisseur, en l'occurrence mesurée selon une direction radiale orthogonale audit axe générateur (XX'), est de préférence comprise entre 0,3 mm et 1 mm, et de façon particulièrement préférentielle voisine de 0,5 mm.Preferably, said joining strip 50 is in the form of a ribbon whose height, in this case measured parallel to the generating axis (XX '), is substantially equal to that of the external faces 5E, 105E, and whose the thickness, in this case measured in a radial direction orthogonal to said generating axis (XX '), is preferably between 0.3 mm and 1 mm, and particularly preferably close to 0.5 mm.
De façon particulièrement préférentielle, la bande de jonction 50 est venue de matière avec le premier et/ou le second bloc élémentaire 5, 105, et de façon particulièrement préférentielle avec l'ensemble des blocs élémentaires 5, 105, 205, 305 formant une même couche annulaire 20.In a particularly preferred manner, the joining strip 50 is integral with the first and / or the second elementary block 5, 105, and particularly preferably with all the elementary blocks 5, 105, 205, 305 forming a single annular layer 20.
De préférence, tel que cela est illustré à la figure 8, la bande de jonction 50 forme une jante périphérique qui relie les faces externes 5E, 105E, 205E, 305E des blocs élémentaires sensiblement selon le contour de la surface de base 11.Preferably, as shown in FIG. 8, the joining strip 50 forms a peripheral rim which connects the outer faces 5E, 105E, 205E, 305E of the elementary blocks substantially in the contour of the base surface 11.
Ainsi, la bande de jonction 50 entoure les blocs élémentaires selon un contour fermé, et forme avec lesdits blocs élémentaires une sorte de courroie crantée destinée à être rapportée sur une armature ajourée formée de piliers 31.Thus, the joining strip 50 surrounds the elementary blocks in a closed contour, and forms with said elementary blocks a sort of toothed belt intended to be attached to a perforated reinforcement formed of pillars 31.
Avantageusement, les faces latérales 5L, 105L de deux blocs élémentaires 5, 105 voisins reliés par la même bande de jonction 50 sont espacés par une encoche 51 dont la forme et les dimensions correspondent sensiblement à celles de la cloison anti-perforation 10 destinée à être insérée entre les deux blocs.Advantageously, the lateral faces 5L, 105L of two adjacent elementary blocks 5, 105 connected by the same joining strip 50 are spaced apart by a notch 51 whose shape and dimensions correspond to substantially to those of the anti-perforation partition 10 to be inserted between the two blocks.
Avantageusement, une bande de jonction 50 conforme à l'invention permet d'une part de solidariser les blocs élémentaires, et ainsi de simplifier leur manipulation lors de l'assemblage tout en améliorant la stabilité et la robustesse globale du boîtier, et d'autre part, grâce à son élasticité intrinsèque, d'exercer un effort de compression radiale centrifuge qui tend à plaquer les blocs élémentaires contre les piliers 31.Advantageously, a joining strip 50 according to the invention makes it possible on the one hand to secure the elementary blocks, and thus to simplify their handling during assembly while improving the overall stability and robustness of the housing, and on the other hand partly, thanks to its intrinsic elasticity, to exert a centrifugal radial compressive force which tends to press the elementary blocks against the pillars 31.
Bien entendu, la présente invention est susceptible de faire l'objet de variations, l'homme du métier étant en mesure d'apprécier le nombre, la forme et les dimensions des blocs élémentaires, et le cas échéant des éléments d'armature modulaires de type piliers 31 ou traverses 32 en fonction de la dimension, de la forme, et de la destination du site 1 , et plus particulièrement du boîtier 2 et de la chambre 3.Of course, the present invention is capable of being subject to variations, the person skilled in the art being able to appreciate the number, the shape and the dimensions of the elementary blocks, and if necessary the modular reinforcing elements of type pillars 31 or sleepers 32 depending on the size, shape, and destination of the site 1, and more particularly the housing 2 and the chamber 3.
La présente invention se rapporte également à un procédé de fabrication d'un dispositif médical implantable 1 tel que décrit ci-dessus, et plus particulièrement à un site implantable 1 destiné à l'injection et/ou au prélèvement de substance fluide dans un organisme humain ou animal et comprenant un boîtier 2 qui délimite une chambre 3 destinée à accueillir ladite substance fluide.The present invention also relates to a method of manufacturing an implantable medical device 1 as described above, and more particularly to an implantable site 1 intended for injecting and / or sampling fluid substance in a human body or animal and comprising a housing 2 which defines a chamber 3 for accommodating said fluid substance.
Selon une caractéristique importante de l'invention, ledit procédé de fabrication comporte une étape (a) d'assemblage d'une zone de ponction plurale au cours de laquelle on dispose côte à côte au moins un premier bloc élémentaire et un second élémentaire, réalisés chacun dans un matériau auto-obturant transperçable par l'aiguille, de manière à orienter leurs faces externes respectives 5E, 105E vers l'extérieur du boîtier 2, leurs faces internes respectives 51, 1051 vers l'intérieur de la chambre 3, et au moins une portion de leurs faces latérales respectives 5L, 105L sensiblement en vis-à- vis l'une de l'autre.According to an important characteristic of the invention, said manufacturing method comprises a step (a) of assembling a plural puncture zone during which at least a first elementary block and a second elementary element are arranged side by side. each in a self-sealing material pierceable by the needle, so as to orient their respective outer faces 5E, 105E towards the outside of the housing 2, their respective inner faces 51, 1051 towards the inside of the chamber 3, and least one portion of their respective lateral faces 5L, 105L substantially vis-à-vis one another.
De préférence, au cours de l'étape (a) d'assemblage, on veille à positionner la face externe 105E du second bloc élémentaire 105 sensiblement dans le prolongement de la face externe 5E du premier bloc élémentaire 5.Preferably, during the step (a) of assembly, care is taken to position the outer face 105E of the second elementary block 105 substantially in the extension of the outer face 5E of the first elementary block 5.
Il est remarquable que, selon la configuration du site implantable 1 conformément à l'une ou l'autre des variantes décrites ci-dessus, l'étape (a) d'assemblage de la zone de ponction plurale peut comporter une sous- étape (ai) d'approche axial au cours de laquelle on rapporte le premier et/ou le second bloc élémentaire 5, 105 dans une structure d'accueil, tel qu'un flasque terminal ou intermédiaire, selon une direction sensiblement parallèle à l'axe générateur (XX') du boîtier 2.It is remarkable that, according to the configuration of the implantable site 1 according to one or other of the variants described above, the step (a) of assembly of the plural puncture zone may comprise a sub-step ( a) of axial approach during which the first and / or the second elementary block 5, 105 is reported in a reception structure, such as a terminal or intermediate flange, in a direction substantially parallel to the generating axis (XX ') of the housing 2.
Plus particulièrement, au cours de la sous-étape (ai) d'approche axiale, on rapporte soit individuellement soit collectivement les blocs élémentaires entre les piliers 31 et les cloisons 10 en les enfilant « parle dessus » du site 1.More particularly, during the sub-step (a1) of axial approach, is reported either individually or collectively the elementary blocks between the pillars 31 and the partitions 10 by threading them "above" site 1.
De préférence, Ia sous-étape (ai) d'approche axiale est répétée avec autant de blocs élémentaires que nécessaire pour obtenir une couche annulaire complète autour de l'axe générateur (XX').Preferably, the axial approach sub-step (a1) is repeated with as many elementary blocks as necessary to obtain a complete annular layer around the generator axis (XX ').
Ensuite, l'étape (a) d'assemblage comporte de préférence une sous- étape (a2) d'élévation au cours de laquelle on dispose, de préférence par approche axiale, au moins un bloc élémentaire par-dessus le ou les blocs élémentaires déjà en place.Next, the assembly step (a) preferably comprises an elevation sub-step (a2) in which at least one elementary block is disposed over the elementary block or blocks, preferably by axial approach. already in place.
Le cas échéant, une sous-étape (a3) d'interposition peut être mise en œuvre entre la sous-étape (ai) d'approche axiale et la sous-étape (a2) d'élévation, au cours de laquelle on dispose par dessus le ou les blocs élémentaires déjà en place une ou plusieurs traverses 32.If necessary, a sub-step (a3) of interposition can be implemented between the sub-step (ai) of axial approach and the sub-step (a2) of elevation, during which is disposed over the elementary block or blocks already in place one or more sleepers 32.
Bien entendu, il est envisageable d'enchaîner tout d'abord un ou plusieurs cycle comprenant la sous-étape (ai) d'approche axiale et la sous-étape (a2) d'élévation, de sorte à bâtir une colonne verticale en remplissant l'espace compris entre deux cloisons 10, en alternant de préférence la pose de blocs élémentaires et de traverses 32, puis ensuite de répéter ce cycle pour bâtir une colonne voisine.Of course, it is conceivable to first chain one or more cycles comprising the sub-step (ai) of axial approach and the substep (a2) of elevation, so as to build a vertical column by filling the space between two partitions 10, preferably alternating the laying of elementary blocks and sleepers 32, and then repeat this cycle to build a neighboring column.
Si le site 1 comporte une structure alvéolée préformée présentant des logements destinés à accueillir un ou plusieurs blocs élémentaires, l'étape (a) d'assemblage de la zone de ponction plurale peut comporter une sous- étape (a4) d'approche radiale au cours de laquelle on rapporte, individuellement ou collectivement, un ou plusieurs bloc(s) élémentaire(s) en les enfonçant dans les montures selon une direction radiale centripète sensiblement normale à l'axe générateur (XX')If the site 1 comprises a preformed honeycomb structure having housings for accommodating one or more elementary blocks, the step (a) of assembly of the plural puncture zone may include a sub-step (a4) radial approach to in which one or more elementary blocks are reported, individually or collectively, by driving them into the frames in a centripetal radial direction substantially normal to the generating axis (XX ')
Avantageusement, dans l'un et l'autre cas, le procédé de fabrication comporte une étape (b) de précontrainte tangentielle, de préférence concomitante à la sous-étape (ai) d'approche axiale ou (a4) d'approche radiale au cours de laquelle on provoque déformation par compression des blocs élémentaires, soit au contact des blocs élémentaires voisins, soit au contact des surfaces d'appui des cloisons anti-perforation 10, de manière à forcer le rapprochement de la surface latérale gauche 5LG et de la surface latérale droite 5LD appartenant à un même bloc élémentaire 5.Advantageously, in either case, the manufacturing method comprises a step (b) of tangential prestressing, preferably concomitant with the substep (ai) of axial approach or (a4) of radial approach to during which the elementary blocks are deformed by compression, either in contact with the neighboring elementary blocks, or in contact with the bearing surfaces of the anti-perforation partitions 10, so as to force the approach of the left lateral surface 5LG and the right side surface 5LD belonging to the same elementary block 5.
Il est remarquable que l'insertion à force des blocs élémentaires se poursuit de préférence jusqu'à encliquetage de ces derniers au niveau de leurs tenons et/ou mortaises respectifs. De préférence, Ie procédé de fabrication comporte également une étape (c) de mise en compression axiale au cours de laquelle on force le rapprochement mutuel des flasques terminaux 12, 13, par exemple en utilisant les piliers 31 comme des tirants, de manière à pré-contraindre également les blocs élémentaires en compression axiale.It is remarkable that the forced insertion of the elementary blocks is preferably continued until latching of the latter at their respective tenons and / or mortises. Preferably, the manufacturing method also comprises a step (c) of axial compression in which the mutual engagement of the end flanges 12, 13 is forced, for example by using the pillars 31 as tie rods, so as to preclude also to constrain the elementary blocks in axial compression.
Par ailleurs, le procédé de fabrication conforme à l'invention peut en outre comporter une étape (d) d'accouplement au cours de laquelle on lie intimement deux à deux les blocs élémentaires voisins, par exemple en faisant fusionner, au moins partiellement, par voie chimique, photochimique ou thermique, leurs faces latérales respectives situées en vis-à-vis l'une de l'autre, ou encore en injectant autour des blocs élémentaires et/ou entre blocs élémentaires voisins une substance de jointoiement.Furthermore, the manufacturing method according to the invention may further comprise a step (d) of coupling during which the neighboring elementary blocks are intimately connected in pairs, for example by fusing, at least partially, by chemical, photochemical or thermal, their respective lateral faces located vis-à-vis one another, or by injecting around the elementary blocks and / or between neighboring building blocks a grouting substance.
Ainsi, le dispositif conforme à l'invention présente avantageusement une structure modulaire qui simplifie et standardise son assemblage, tout en garantissant une bonne étanchéité et une grande longévité dudit site.Thus, the device according to the invention advantageously has a modular structure that simplifies and standardizes its assembly, while ensuring a good seal and a long life of said site.
Avantageusement, le site implantable conforme à l'invention présente à la fois une accessibilité optimisée et un faible encombrement, les éléments constitutifs de la zone de ponction occupant un volume relativement modeste en comparaison du volume total utile du site.Advantageously, the implantable site according to the invention has both an optimized accessibility and a small footprint, the constituent elements of the puncture area occupying a relatively modest volume compared to the total useful volume of the site.
Par ailleurs, il est remarquable que la conception modulaire du site autorise de nombreuses adaptions de la longueur totale dudit site par simple ajout de rangées supplémentaires de blocs élémentaires selon l'axe générateur (XX'). Furthermore, it is remarkable that the modular design of the site allows many adaptations of the total length of said site by simply adding additional rows of elementary blocks along the generator axis (XX ').

Claims

REVENDICATIONS
- Dispositif médical implantable (1) destiné à l'injection et/ou au prélèvement de substance fluide dans un organisme humain ou animal et comprenant un boîtier (2) qui délimite une chambre (3) destinée à accueillir ladite substance fluide, ledit dispositif étant caractérisé en ce qu'il comporte une zone de ponction (4) plurale conçue pour pouvoir être transpercée par une aiguille destinée à injecter ou à ponctionner ladite substance fluide dans ladite chambre (3), ladite zone de ponction (4) plurale comprenant au moins un premier bloc élémentaire (5) et un second bloc élémentaire (105) réalisés chacun dans un matériau auto-obturant transperçable par l'aiguille et présentant chacun une face externe (5E, 105E) orientée vers l'extérieur du boîtier (2), une face interne (51, 1051) orientée vers l'intérieur de Ia chambre (3), et une face latérale (5L, 105L) joignant la face externe à Ia face interne, lesdits premier et second bloc élémentaire (5, 105) étant disposés côte à côte de sorte à présenter au moins une portion de leurs faces latérales (5L, 105L) respectives sensiblement en vis-à-vis l'une de l'autre.Implantable medical device (1) intended for injecting and / or taking fluid substance from a human or animal body and comprising a housing (2) which delimits a chamber (3) intended to receive said fluid substance, said device being characterized in that it comprises a plural puncture zone (4) designed to be pierced by a needle for injecting or puncturing said fluid substance in said chamber (3), said plural puncture zone (4) comprising at least a first elementary block (5) and a second elementary block (105) each made of a self-sealing material pierceable by the needle and each having an outer face (5E, 105E) facing outwardly of the housing (2), an inner face (51, 1051) facing inwardly of the chamber (3), and a side face (5L, 105L) joining the outer face to the inner face, said first and second elementary blocks (5, 105) and arranged side by side so as to have at least a portion of their respective lateral faces (5L, 105L) substantially facing each other.
- Dispositif selon la revendication 1 caractérisé en ce que la face externe (105E) du second bloc élémentaire (105) est disposée sensiblement dans Ie prolongement de la face externe (5E) du premier bloc élémentaire (5).- Device according to claim 1 characterized in that the outer face (105E) of the second elementary block (105) is disposed substantially in the extension of the outer face (5E) of the first elementary block (5).
- Dispositif selon la revendication 1 ou 2 caractérisé en ce que les portions de faces latérales (5L, 105L) respectives du premier et du second bloc élémentaire (5, 105) présentent des formes sensiblement conjuguées et s'étendent sensiblement parallèlement l'une à l'autre. 4 - Dispositif selon l'une des revendications 1 à 3 caractérisé en ce que le premier et le second bloc élémentaire (5, 105) sont immédiatement juxtaposés de telle sorte que leurs faces latérales respectives se trouvent au contact direct l'une de l'autre.- Device according to claim 1 or 2 characterized in that the respective side-face portions (5L, 105L) of the first and second elementary blocks (5, 105) have substantially conjugate shapes and extend substantially parallel to each other. the other. 4 - Device according to one of claims 1 to 3 characterized in that the first and the second elementary block (5, 105) are immediately juxtaposed so that their respective lateral faces are in direct contact with one of the other.
5 - Dispositif selon l'une des revendications 1 à 3 caractérisé en ce que le premier et le second bloc élémentaire (5, 105) sont séparés par une cloison anti-perforation (10) interposée entre leurs portions de faces latérales (5L, 105L) situées en vis-à-vis l'une de l'autre, ladite cloison anti-perforation (10) étant conçue pour faire obstacle à la pénétration transverse d'une aiguille.5 - Device according to one of claims 1 to 3 characterized in that the first and the second elementary block (5, 105) are separated by an anti-perforation partition (10) interposed between their side faces portions (5L, 105L ) located opposite each other, said anti-perforation partition (10) being designed to prevent the transverse penetration of a needle.
6 - Dispositif selon la revendication 5 caractérisé en ce que la cloison antiperforation (10) est formée par une plaque dont l'épaisseur est sensiblement comprise entre 0,3 et 2 mm, et de préférence comprise entre 0,5 et 1 ,5 mm.6 - Device according to claim 5 characterized in that the antiperforation partition (10) is formed by a plate whose thickness is substantially between 0.3 and 2 mm, and preferably between 0.5 and 1.5 mm .
7 - Dispositif selon la revendication 5 ou 6 caractérisé en ce que la cloison anti-perforation (10) se prolonge dans la chambre (3) de manière à former un écran anti-transpercement (21) conçu pour empêcher une aiguille de traverser le boîtier de part en part.7 - Device according to claim 5 or 6 characterized in that the anti-perforation partition (10) extends into the chamber (3) so as to form an anti-piercing screen (21) designed to prevent a needle from passing through the housing from side to side.
8 - Dispositif selon l'une des revendications précédentes caractérisé en ce que le premier et Ie second bloc élémentaire (5, 105) forment une zone de ponction (4) globalement convexe par rapport à l'extérieur du dispositif (1).8 - Device according to one of the preceding claims characterized in that the first and the second elementary block (5, 105) form a puncture zone (4) generally convex relative to the outside of the device (1).
9 - Dispositif selon l'une des revendications précédentes caractérisé en ce que le boîtier (2) présente une géométrie sensiblement cylindrique générée par une surface de base (11) selon un axe générateur (XX'). - Dispositif selon la revendication 9 caractérisé en ce que la surface de base (11) est formée par un disque, une portion de disque telle qu'un secteur angulaire, un croissant, un demi-disque ou un quartier, une surface elliptique ou ellipsoïde, ou une surface polygonale, telle qu'un triangle, un rectangle, un carré ou un hexagone.9 - Device according to one of the preceding claims characterized in that the housing (2) has a substantially cylindrical geometry generated by a base surface (11) along a generator axis (XX '). - Device according to claim 9 characterized in that the base surface (11) is formed by a disk, a disk portion such as an angular sector, a crescent, a half-disk or a quarter, an elliptical surface or ellipsoid , or a polygonal surface, such as a triangle, a rectangle, a square, or a hexagon.
- Dispositif selon la revendication 9 ou 10 caractérisé en ce que la zone de ponction (4) s'étend au moins en partie sur la paroi latérale du boîtier cylindrique (2).- Device according to claim 9 or 10 characterized in that the puncture zone (4) extends at least partially on the side wall of the cylindrical housing (2).
- Dispositif selon l'une des revendications 9 à 11 caractérisé en ce que la couverture angulaire de la zone de ponction, considérée dans un plan normal à l'axe générateur (XX'), est supérieure ou égale à 90°, de préférence supérieure ou égale à 180°, et de façon particulièrement préférentielle supérieure ou égale à 300°.- Device according to one of claims 9 to 11 characterized in that the angular coverage of the puncture area, considered in a plane normal to the generator axis (XX '), is greater than or equal to 90 °, preferably greater or equal to 180 °, and particularly preferably greater than or equal to 300 °.
-Dispositif selon l'une des revendications 9 à 12 caractérisé en ce que la zone de ponction (4) comporte une pluralité de blocs élémentaires (5, 105, 205, 305, 405, 505, 605, 705), disposés côte à côte de manière à former une couche annulaire (20) dont le contour correspond à celui de la surface de base (11).-Dispositif according to one of claims 9 to 12 characterized in that the puncture zone (4) comprises a plurality of elementary blocks (5, 105, 205, 305, 405, 505, 605, 705) arranged side by side to form an annular layer (20) whose contour corresponds to that of the base surface (11).
- Dispositif selon la revendication 13 caractérisé en ce qu'il comporte une pluralité de couches annulaires (20, 20A, 20B) superposées selon la direction de l'axe générateur (XX').- Device according to claim 13 characterized in that it comprises a plurality of annular layers (20, 20A, 20B) superimposed in the direction of the generator axis (XX ').
-Dispositif selon l'une des revendications précédentes caractérisé en ce que le premier et/ou le second bloc élémentaire (5, 105) sont pourvus d'au moins un tenon (40) et/ou d'au moins une mortaise (41) conçu(e) pour permettre leur fixation entre eux ou à un élément fixe du boîtier. - Dispositif selon l'une des revendications précédentes caractérisé en ce que les blocs élémentaires (5, 105, 205, 305, 405, 505, 605, 705) sont identiques.-Dispositif according to one of the preceding claims characterized in that the first and / or the second elementary block (5, 105) are provided with at least one pin (40) and / or at least one mortise (41) designed to allow attachment between them or to a fixed element of the housing. - Device according to one of the preceding claims characterized in that the elementary blocks (5, 105, 205, 305, 405, 505, 605, 705) are identical.
- Dispositif selon l'une des revendications précédentes caractérisé en ce qu'il comprend un châssis alvéolé modulaire (30) comportant plusieurs piliers (31) reliés par des traverses (32) indépendantes, lesdits piliers et lesdites traverses formant des montures dans lesquelles les blocs élémentaires (5, 105, 205, 305, 405, 505, 605, 705) sont enchâssés.- Device according to one of the preceding claims characterized in that it comprises a modular honeycomb frame (30) having a plurality of pillars (31) connected by cross members (32) independent, said pillars and said sleepers forming frames in which the blocks Elementals (5, 105, 205, 305, 405, 505, 605, 705) are enshrined.
- Dispositif selon l'une des revendications précédentes caractérisé en ce que le premier et le second bloc élémentaire (5, 105) sont intrinsèquement distincts l'un de l'autre.- Device according to one of the preceding claims characterized in that the first and the second elementary block (5, 105) are intrinsically distinct from each other.
- Dispositif selon l'une des revendications 1 à 17 caractérisé en ce que le premier et le second bloc élémentaire (5, 105) sont reliés entre eux par une bande de jonction (50).- Device according to one of claims 1 to 17 characterized in that the first and the second elementary block (5, 105) are interconnected by a connecting strip (50).
- Dispositif selon la revendication 19 caractérisé en ce que la bande de jonction (50) est venue de matière avec le premier et/ou le second bloc élémentaire (5, 105).- Device according to claim 19 characterized in that the joining strip (50) is integral with the first and / or the second elementary block (5, 105).
- Dispositif selon la revendication 13 et l'une des revendications 19 ou 20 caractérisé en ce que la bande de jonction (50) forme une jante périphérique reliant les faces externes (5E1 105E, 205E, 305E) des blocs élémentaires (5, 105, 205, 305) sensiblement selon le contour de la surface de base (11).- Device according to claim 13 and one of claims 19 or 20 characterized in that the joining strip (50) forms a peripheral rim connecting the outer faces (5E 1 105E, 205E, 305E) of the elementary blocks (5, 105). 205, 305) substantially in the contour of the base surface (11).
-Procédé de fabrication d'un dispositif médical implantable (1) destiné à l'injection et/ou au prélèvement de substance fluide dans un organisme humain ou animal et comprenant un boîtier (2) qui délimite une chambre (3) destinée à accueillir ladite substance fluide, ledit procédé de fabrication étant caractérisé en ce qu'il comporte une étape (a) d'assemblage d'une zone de ponction (4) plurale au cours de laquelle on dispose côte à côte au moins un premier bloc élémentaire (5) et un second bloc élémentaire (105), réalisés chacun dans un matériau auto-obturant transperçable par une aiguille, de manière à orienter leurs faces externes respectives (5E, 105E) vers l'extérieur du boîtier (2), leurs faces internes respectives (51, 1051) vers l'intérieur de la chambre (3), et au moins une portion de leurs faces latérales respectives (5L, 105L) sensiblement en vis-à-vis l'une de l'autre. -Process of manufacturing an implantable medical device (1) for the injection and / or sampling of fluid substance in a human or animal body and comprising a housing (2) which delimits a chamber (3) intended to accommodate said fluid substance, said manufacturing method being characterized in that it comprises a step (a) of assembling a plural puncture zone (4) during which one disposes side by side at least a first elementary block (5) and a second elementary block (105), each made of a self-sealing material pierceable by a needle, so as to orient their respective outer faces (5E, 105E) towards the outside of the housing (2), their respective inner faces (51, 1051) towards the inside of the chamber (3), and at least a portion of their respective lateral faces (5L, 105L) substantially facing each other. the other.
PCT/FR2007/001399 2006-09-08 2007-08-24 Implantable site with multifacet septum WO2008029010A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP07823447A EP2066390A1 (en) 2006-09-08 2007-08-24 Implantable site with multifacet septum

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
FR0607905 2006-09-08
FR0607905A FR2905603B1 (en) 2006-09-08 2006-09-08 IMPLANTABLE SITE WITH MOBILE SHUTTER.
FR0701487 2007-03-01
FR0701487A FR2913203B1 (en) 2007-03-01 2007-03-01 IMPLANTABLE SITE WITH MULTIPLE DEFLECTORS
FR0702482 2007-04-05
FR0702482A FR2914561B1 (en) 2007-04-05 2007-04-05 IMPLANTABLE SITE WITH CAM SCREEN

Publications (1)

Publication Number Publication Date
WO2008029010A1 true WO2008029010A1 (en) 2008-03-13

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PCT/FR2007/001399 WO2008029010A1 (en) 2006-09-08 2007-08-24 Implantable site with multifacet septum

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EP (1) EP2066390A1 (en)
WO (1) WO2008029010A1 (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2928275A1 (en) * 2008-03-06 2009-09-11 Cie Euro Etude Rech Paroscopie IMPLANTABLE SITE WITH SCREEN PENETRANT IN THE SEPTUM
FR2935904A1 (en) * 2008-09-18 2010-03-19 Cie Euro Etude Rech Paroscopie IMPLANTABLE SITE WITH SEPTUM WITH BIDIRECTIONAL PRE-CONSTRAINT

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2507895A1 (en) * 1981-06-19 1982-12-24 Serac Sa Tubular insert for needle injections into transfusion pipeline - has chamfered surface(s) to facilitate entry of needle
GB2192338A (en) * 1986-07-07 1988-01-13 Bristol Myers Co Septum
US6261257B1 (en) * 1998-05-26 2001-07-17 Renan P. Uflacker Dialysis graft system with self-sealing access ports
WO2006021695A1 (en) * 2004-08-19 2006-03-02 Companie Europeenne D'etude Et De Recherche De Dispositifs Pour L'implantation Par Laparoscopie Implantable medical site

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2507895A1 (en) * 1981-06-19 1982-12-24 Serac Sa Tubular insert for needle injections into transfusion pipeline - has chamfered surface(s) to facilitate entry of needle
GB2192338A (en) * 1986-07-07 1988-01-13 Bristol Myers Co Septum
US6261257B1 (en) * 1998-05-26 2001-07-17 Renan P. Uflacker Dialysis graft system with self-sealing access ports
WO2006021695A1 (en) * 2004-08-19 2006-03-02 Companie Europeenne D'etude Et De Recherche De Dispositifs Pour L'implantation Par Laparoscopie Implantable medical site

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2928275A1 (en) * 2008-03-06 2009-09-11 Cie Euro Etude Rech Paroscopie IMPLANTABLE SITE WITH SCREEN PENETRANT IN THE SEPTUM
WO2009115743A3 (en) * 2008-03-06 2009-12-17 Compagnie Europeenne D'etude Et De Recherche De Dispositifs Pour L'implantation Par Laparoscopie Implantable site with screen engaging in the septum
FR2935904A1 (en) * 2008-09-18 2010-03-19 Cie Euro Etude Rech Paroscopie IMPLANTABLE SITE WITH SEPTUM WITH BIDIRECTIONAL PRE-CONSTRAINT
WO2010031812A1 (en) 2008-09-18 2010-03-25 Compagnie Européenne D'etude Et De Recherche De Dispositifs Pour L'implantation Par Laparoscopie Implantable site with septum prestressed in two directions
US8328773B2 (en) 2008-09-18 2012-12-11 Compagnie Europeenne D'etude Et De Recherche De Dispositifs Pour L'impantation Par Laparoscopie Implantable site with septum prestressed in two directions

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