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
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WO
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Application
Patent type
Prior art keywords
characterized
block
device according
side
elementary
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
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0208Subcutaneous access sites for injecting or removing fluids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0208Subcutaneous access sites for injecting or removing fluids
    • A61M2039/022Subcutaneous access sites for injecting or removing fluids being accessible from all sides, e.g. due to a cylindrically-shaped septum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0208Subcutaneous access sites for injecting or removing fluids
    • A61M2039/0226Subcutaneous 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

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

IWIPLANTABLE SITE WITH multifaceted SEPTUM

The present invention relates to the field of implantable medical devices of the type intended for injection or removal of fluid substance in the body of a patient.

The present invention relates more particularly to an implantable medical device for injecting and / or harvesting of fluid substance in a human or animal body and comprising a housing which delimits a chamber for receiving said fluid substance.

It is known to implant under the skin of a patient a medical device, called "implantable site", to form a remote access point for the transfer of material to or from the blood circulation system, tissues of an organ, or an inflatable implant such as a balloon or a constriction ring.

Generally, such implantable site is in the form of a housing within which is formed a chamber which communicates, via an outlet, with a flexible catheter connecting said housing to the target area which is intended, respectively of from where the injected substance, respectively taken.

To allow access to the chamber through a needle, the wall of the housing generally has a drain zone formed by a self-sealing membrane or "septum", made from an elastomer material such that the sealing of the site is preserved as well as the needle pierces the wall until it withdraws from the hole formed by said needle closing automatically during the extraction thereof by phenomenon elastic self-healing. Although they are generally satisfactory, the implantable sites of the prior art, however, suffer from significant drawbacks.

Indeed, to ensure the mechanical integrity of the site and its seal even when the latter was stung multiple times, it is usually necessary to provide self-sealing membranes relatively thick.

In addition, said self-sealing membranes frequently exhibit a low extent so as to be properly held in a housing formed in the housing, and preferably inserted by force in said housing to ensure their compressive prestress.

Therefore, puncture areas of the prior art often have a useful floor area and a relatively restricted accessibility in comparison to the overall size of the implantable site.

The objects of the present invention are therefore to remedy the aforementioned drawbacks and to propose a new implantable medical device for the injection and / or removal of fluid substance in a human or animal that is particularly easy to access, has a small footprint and has a long service life.

Another object assigned to the invention aims to propose a new implantable medical device which is particularly simple and compact structure.

Another object assigned to the invention aims to propose a new implantable medical device that allows the practitioner to achieve a stitching reliably and safely. Another object assigned to the invention aims to propose a new implantable medical device atraumatic minimizing inconvenience to the patient.

Another object assigned to the invention aims to propose a new implantable medical device, the operation can be ensured even in a rollover on said device itself.

Another object assigned to the invention aims to propose a new implantable medical device having a particularly robust and stable structure.

Another object assigned to the invention aims to propose a new implantable medical device feasible for a low cost of manufacture with a small number of standardized parts.

Another object assigned to the invention aims to propose a new implantable medical device whose structure is modular and scalable.

The objects of the invention are also to propose a new method of making an implantable medical device that advances a simple and inexpensive way an implantable medical device having good accessibility, a long service life and compact.

The objects of the invention are achieved using an implantable medical device for injecting and / or harvesting of fluid substance in a human or animal body and comprising a housing which delimits a chamber for receiving said fluid substance, said device being characterized in that it comprises a plural puncture zone designed to be pierced by a needle for injecting or puncturing said fluid in said chamber, said plural puncture area comprising at least a first block and a second elementary each elementary block made of a self-sealing material pierceable by the needle and each having an outer face facing outwardly of the housing, a facing inner surface inwardly of the chamber and a side surface joining the outer face to the inner face, said first and second elementary block being arranged side by side so as to have at least a portion of their respective side surfaces substantially in vis-à-vis one another.

The objects assigned to the invention are also achieved with a method of manufacturing an implantable medical device for injecting and / or harvesting of fluid substance in a human or animal body and comprising a housing defines a chamber for accommodating said fluid, said manufacturing method being characterized in that it comprises a step (a) assembling a puncture area, plural in which there are at least side by side a first component block and a second block element, each made of a self-sealing material pierceable by the needle, so as to orient their respective external faces outwardly of the housing, their respective internal faces inwardly of the chamber and at least a portion of their respective side surfaces substantially in vis-à-vis one another.

Other objects, features and advantages of the invention appear in greater detail on reading the following description and to the accompanying drawings, provided purely for illustrative and not limiting, including:

- Figure 1 shows, in a perspective view, a first variant embodiment of an implantable medical device according to the invention. - Figure 2 shows, in a detail view in perspective, a constituent element of the device shown in Figure 1.

- Figure 3 illustrates, in an exploded perspective view with partial cutaway view, the medical device shown in Figure 1.

- Figure 4 illustrates, in a perspective view with cutaway and partial burst, a second alternative embodiment of a device according to the invention.

- Figure 5 illustrates, in a perspective view, a third medical device embodiment according to the invention.

- Figure 6 illustrates, in a longitudinal sectional view of the device shown in Figure 5.

- Figure 7 illustrates, in an exploded perspective view, a part of the device shown in Figures 5 and 6.

- Figure 8 illustrates, in exploded perspective view, a fourth alternative embodiment of a medical device according to the invention.

- The figure 9 shows, in a schematic exploded perspective view, a basic block according to the invention.

The invention relates to an implantable medical device 1 for injecting and / or the removal of substance (s) fluid (s) in a human or animal body.

Such a device 1, also designated by the term "implantable site" is intended to be surgically implanted into the body of a patient, preferably under the skin of said patient, in order to constitute an access point for the introduction or extraction of substance (s) fluid (s) within the body of said patient.

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

In particular, the device 1 according to the invention can be designed for injection and / or drawing fluid into an organ or into the circulatory system, for example to allow the injection of substance (s) drug (s) . According to one embodiment 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 to inject a therapeutic substance or draw blood.

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

Said device 1 can finally be suitable for injection and the fluid puncture in the inflatable compartment or deflatable compartment of a surgical implant such as an artificial sphincter, a balloon or a gastric ring for effecting a constriction of the stomach for the fight against obesity.

In what follows, we particularly consider the device 1 constitutes a hypodermic device, that is to say it is designed to be positioned just beneath the patient's skin, whereby said device can be implanted to other places in the body of the patient and more deeply within the scope of the invention. According to the invention, the device 1 comprises a housing 2 defining a chamber 3, said chamber 3 being intended to accommodate the injected fluid or substance charged.

The device 1 also comprises a drain region 4 adapted to be pierced by a needle for injecting or puncturing the fluid substance in the chamber.

Advantageously, said puncture area 4 seals the device 1 both during the stitching by said needle and transfer fluid consecutively to the withdrawal of said needle.

According to an important feature of the invention, the puncture area 4 is plural, and includes at least a first elementary block 5 and a second elementary block 105, each formed in a self-sealing material pierceable by the needle, said first and second elementary block 5, 105 each having an outer face 5E, 105E oriented outwardly of the housing, an inner face 51, 1051 facing the interior of the chamber 3, and a side 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 side faces 5L, 105L substantially vis-à-vis the one of the other.

By "self-sealing material pierceable by the needle" is meant any material that can be used to perform a self-sealing membrane or "septum", that is to say, any material, preferably biocompatible, capable of being perforated by a needle including a hollow needle and then able to automatically reseal the orifice generated by drilling, after extraction of said needle, by springback. For example, the block elements may be made from a biocompatible elastomer such as silicone.

Advantageously, the arrangement according to the invention allows a puncture area 4 "multifaceted" is to say, to divide or split said puncture area into a plurality of block elements by which a needle can access in the chamber 3.

In this respect, it is noteworthy that the first and second elementary block form two neighboring areas to be one and the same chamber 3.

Thus, it is advantageously possible to construct a particularly large puncture area relative to the overall outer surface of the implantable site 1, while limiting the dimensions of the elementary blocks 5, 105 constituent of said plural puncture area 4 and therefore the fragility or the intrinsic flexibility of the latter.

As will be detailed below, it is in particular possible to reduce the thickness of the elementary blocks forming septa, and therefore the overall dimensions of site 1, while maintaining sufficient structural rigidity of the puncture area 4 and the site 1 as a whole.

Of course, the shape of said building blocks according to the invention is not limited.

For example, an elementary block 5, 105 may be present generally in the form of a polyhedron, preferably six-sided, such as a rectangular parallelepiped or a cube, or as a portion of annular ring of circular cross-section, elliptical, polygonal, square, etc. In particular, as shown in Figures 3, 4, 7 and 8, the block elements can form annular ring portions having outer and inner faces substantially rectangular and curved.

For convenience of description and without this constituting a limitation of the invention, will be considered with reference to the simplified example shown in Figure 9 that each elementary block 5 is full and has six faces, namely a internal face 51 "front", an outer face 5E "rear", and a 5L side face formed by a set of four sides, preferably plane, designated by convention as "left side faces" 5LG, "right side face" 5LD, "upper side surface" 5LS and "lower side surface" 5LL.

Within the meaning of the invention there may be "having side by side" the first elementary block 5 and the second basic block 105 or by superimposing them, for example by placing the lower side face of the second block 105Ll 105 vis-à-vis of the upper side face of the first block 5LS 5, or by juxtaposing them, for example by placing the left side face 105LG the second block 105 next to the right side face 5LD the first block.

Of course, according to another variant embodiment not shown, the block elements may have a shape substantially cylindrical or frustoconical revolution, their inner and outer faces corresponding to the basic shape of revolution and lateral surfaces then substantially corresponding to a continuous crown .

In other words, the lateral face 5L correspond to the union of the edges of the respective elementary block, the latter has a contour forming a continuous line or broken. In addition, although it is possible to combine together several formats of block element, said block element 5, 105 are preferably substantially identical in their shapes, dimensions and composition.

Thus, one can achieve the puncture area 4 using interchangeable standard components, which can significantly limit the scrap rate, ease of assembly, and generally significantly reduces the manufacturing cost of the device 1.

Although it is conceivable to shift a block element with respect to another, for example such that the outer face of an elementary block is re-entrant or projecting with respect to the or the face (s) external (s) or block element neighbors, 105E outer face of the second elementary block 105 will preferably be disposed substantially in the extension of the outer surface 5E of the first elementary block 5.

Thus, the site 1 advantageously has an outer surface substantially free of roughness, which makes it particularly atraumatic and provides little control to the tissue matrix.

Preferably, the portion of lateral face 5L of the first elementary unit 5 and the portion of lateral surface 105L of the second elementary block 105 located vis-à-vis the latter have substantially matching shapes and extend substantially parallel to the to each other.

In addition, the alignment of the external faces and the similarity of blocks of dimensions advantageously allows to obtain an almost total mutually overlapping portions of respective side surfaces of two neighboring building blocks, which optimizes sealing and stability of the assembly thus formed. Of course, in the case where the side faces have a curved geometry, including circular, they can be arranged substantially tangentially to one another without departing from the scope of the invention.

According to a first alternative embodiment which corresponds to Figures 1 to 3, the first elementary block 5 and the second component block 105 are immediately juxtaposed so that their respective side faces 5L, 105L are in direct contact with one of the other.

By touching edge to edge adjacent basic blocks, it is possible to achieve a waterproof structure both simple and compact.

However, preferably, the first elementary block 5 and the second component block 105 are separated from each other, at least partially, by an anti-perforation partition 10 interposed between portions of their side faces 5L, 105L located vis-à-vis one another, said partition 10 being designed to obstruct the transverse penetration of a needle.

In other words, the puncture-resistant partition 10 form a body, preferably rigid, that is resistant to perforation by a needle and that lies at the interface between two adjacent unit blocks, so as to prevent a needle addressing substantially tangentially the housing 2 successively through the first block and the second block without penetrate inside the chamber 3.

Advantageously, this arrangement allows to avoid an accidental pricking tangential wherein the needle remain blocked in the septum or said traverse from one side of the septum to emerge in the tissues, which allows to guarantee a use of both safe and reliable of the device 1 according to the invention. Indeed, if the practitioner feels a resistance to penetration of the needle immediately after biting site 1, it deduces that abuts against a wall 10 and can then correct or resume tapping gesture so as to be some that the end of the needle has actually entered the room and reaches a depth compatible with the functional fluid transfer.

Preferably, as shown in Figures 4, 7 and 8, the penetration wall 10 is formed by a plate, preferably substantially planar, the thickness is preferably substantially between 0.3 mm and 2 mm, and particularly preferably between 0.5 and 1, 5 mm.

Thus, the partition 10 defines a minimum spacing distance between the first and second elementary block 5, 105, which corresponds substantially to the length of a dummy segment normal to the side walls 5L, 105L and corresponding joining the respective points of said walls the shorter side of one another.

Furthermore, the first elementary block 5 and the second component block 105 preferably form a generally convex puncture area 4 with respect to outside the device 1.

Within the meaning of the invention, this convexity may be obtained either by means of elementary blocks 5, 105 having a curved shape whose convex Ie is oriented outwardly, or by means of polyhedral elementary blocks housed in walls of the housing and separate secant, or else by means of polyhedral building blocks having side faces, including left and / or right inclined with respect to the internal face 51 and / or external 5E, so that the arrangement of said side faces parallel to the other leads to the formation of a projecting ridge at the interface between the outer faces of neighboring blocks.

Preferably will employ block elements to the curved or rounded shapes, and particularly preferably elementary blocks whose outer faces 5E, 105E have a continuous curvature in order to avoid abrupt transitions between said unit blocks.

Furthermore, the thickness of the block elements 5, 105 measured between the outer surface 5E, 105E and the inner face 51, 1051 will preferably be substantially constant, so that the convexity of the puncture zone 4 is reflected by a convexity substantially similar to the chamber 3 itself.

Advantageously, such arrangement allows to maximize the useful volume of said chamber 3, to provide access thereto as many directions of approach of the needle, and thus to optimize the compactness and accessibility of the site 1.

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 according to a generating axis (XX ').

By "cylindrical shape" globally denotes any shape obtained when one base surface 11 sweeps any predetermined curve generator forming said axis (XX ').

Preferably, the generating axis (XX '), however, straight. By pure convenience of description, it is considered that said generator axis is vertical (being preferably be oriented substantially parallel to the skin surface after the implanted site 1). The base surface 11 may advantageously be formed by a disc, as shown in the variants illustrated in FIGS.

However, this shape is not limitative, the base surface can also be formed by a disc portion, such as an angular sector corresponding to the portion between two distinct radii and the arc joining the ends of said spokes a growing, half a disk, or a neighborhood.

The base surface 11 may also correspond to an elliptical surface or ellipsoid, or a polygonal surface such as a triangle, a rectangle, a square, a hexagon or any other polygon, convex and preferably regular.

According to a preferred embodiment, the base surface 11 has substantially constant dimensions along the generating axis (XX '), and the housing is closed at each of its ends by a flange terminal 12, 13, preferably resistant puncture.

Of course, the base surface 11 may also have variable dimensions along the generating axis (XX '), that is to say, the site 1 has a cross section, taken in a plane normal to the generating axis (XX '), of variable size according Ie point of said generator axis (XX') or is located, the housing 2 may thus be provided in an ovoid shape, pear-shaped, spherical, etc., without departing from the scope of the invention.

According to a not shown alternative embodiment, the housing 2 may also be in the shape of a polyhedron, such as a cube or a rectangular parallelepiped, the edges then being preferably rounded by 5

fillets in order to keep the site a substantially atraumatic.

Advantageously, such a global polyhedral shape facilitates the assembly site 1 but also to take advantage of particularly stable bearing surfaces against tissue after said implantation site.

Preferably, at least one of the flanges terminals 13 is provided with a connecting piece 14 forming a pipe for connecting an outlet port opening into the chamber 3 to a catheter (not shown).

Preferably, the connecting member 14 and the generator axis (XX ') are coaxial.

Preferably, the puncture zone 4 extends at least partly, more preferably in majority (over 50%), or even exclusively on the side wall of cylindrical housing 2.

In addition, preferably, the angular coverage of the puncture area 4 as viewed in a plane normal to the generating axis (XX ') is greater than or equal to 90 °, preferably greater than or equal to 180 °, and so particularly preferably greater than or equal to 300 ° or even substantially equal to 360 °.

In other words, the chamber 3 is effectively accessible, that is to say the wall of the housing 2 pierceable, on at least a quarter, preferably half, and yet more preferably on almost the entire periphery side of the housing. Advantageously, the puncture area 4, and more generally the housing 2 present a generally invariant geometry fold rotational 2, 3, 4 and / or 6 about the generating axis (XX '), that is, say invariant under rotation of 180 °, 120 °, 90 ° or 60 °, in particular in the case of a polyhedral enclosure or geometry totally invariant by rotation revolution, which makes the device 1 almost insensitive to a turning on itself Also, since it retains its functionality and accessibility in many angular configurations relative to the surface of the skin.

The puncture zone 4 may comprise for this purpose a plurality of block elements 5, 105, 205, 305, 405, 505, 605, 705 arranged side by side so as to form an annular layer 20 whose contour corresponds substantially to that of the base surface 11.

Advantageously, each elementary block covers an angular portion (measured around the generator axis (XX ') in a plane normal thereto) which corresponds to a radial division of the total angular coverage of the puncture zone 4.

Of course, those skilled in the art will be able to assess the number and size of elementary blocks according to the extent of the housing, and more specifically the perimeter of the annular layer 20.

Thus, an annular layer 20 may comprise two elementary blocks, or three elementary blocks, or four block elements (5, 6, 7 and 8), or six elementary blocks, or eight unit blocks or more, arranged in a row for forming a kind of constituent wall of said layer 20.

Naturally, analogously to what has been described above, it is conceivable to dispose an anti-perforation partition 10 between each pair of adjacent elementary blocks within a same annular layer 20, as shown in Figures 4, 7 or 10.

According to a preferred structural arrangement, the (or the) wall (s) penetration 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 adapted to prevent a needle through Ie housing 2 from one side. In particular, a plurality of partitions 10 can reach substantially the center of the chamber to form a cross or a star.

Thus, the practitioner is assured that the needle is actually in the chamber 3 when it seeks to achieve the transfer of fluid.

On the other hand, the block elements 5, 105 preferably have lateral support faces 5L, and more particularly 105L of the left side faces 5LG, 105LG and right 5LD, 105LD which converge inwardly of the chamber, and preferably which extend in intersecting planes whose intersection coincides with the generating axis (XX '), such that said locking block element come into abutment against the walls 10 (or against the other one) in the direction penetration of the needle.

Thus, the block elements can form a kind of discharge arcs that spontaneously oppose a resistance to penetration when a stress of radial centripetal penetration is exerted on their outer surface 5E, 105E and directed inwardly of the chamber 3, and more particularly towards the generator axis (XX ').

On the other hand, the device 1 can advantageously comprise a plurality of annular layers 20, 2OA, 2OB superposed in the direction of the generating axis (XX '). Thus, the site 1 according to the invention may have a plurality of block elements stacked relative to each other, so as to form a matrix structure defining a closed contour of the chamber 3.

Thus, the puncture zone 4 may advantageously have a matrix structure comprising at least two lines (horizontal rows corresponding to annular layers) and at least two columns (vertical rows of blocks belonging to successive annular layers), each of said matrix being formed by an elementary block.

More generally, Ia puncture area 4 according to the invention is preferably modular and divided into a plurality of block elements, namely at least three, separated from each other by at least two intersecting interruption surfaces, Any substantially planar and orthogonal. Preferably, said blocks are arranged side by side in two distinct spatial directions.

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 partly, and preferably completely, by a first area interrupt substantially extending in a first plane, in this case a vertical plane containing the generating axis (XX '), and at least a second level comprising at least one third basic block that overlaps at least part of the first and / or the second elementary block and which is separated at least partially, and preferably completely, thereof, or thereof, by a second interruption zone extending substantially along a second cutting plane, and in the case orthogonal in the foreground. Moreover, the various annular layers 20, 2OA, 2OB can be separated from one another by intermediate plates 21, 22, preferably rigid and resistant to perforation.

Preferably, as shown in Figure 2, said intermediate flanges 21, 22 are formed by washers disposed substantially normally generator axis (XX ').

Thus, the puncture zone 4 may be partitioned both radially, by the partitions 10, and transversely by the intermediate flanges 21, 22, the assembly thus forming a honeycomb structure.

Walls 10 may also be integral with one or more intermediate flanges 21, 22.

Preferably, the unit blocks 5, 105, 205, 305, 405, 505, 605, 705 are identical in their sizes and composition.

According to another variant embodiment not shown, the first and second elementary block are each formed by a full ring segment, preferably obtained by scanning a rectangular or square cross section around the generator axis (XX '), said ring segments being simply stacked one above the other, optionally separated by an intermediate flange.

According to an alternative embodiment illustrated in Figure 7, the device comprises a modular honeycomb frame 30 which comprises a plurality of pillars 31, preferably connected by 32 independent crossbars, said pillars 31 forming, preferably in combination with said cross members 32, mounts in which the block elements 5, 105, 205, 305 are embedded. Such a modular structure is advantageously scalable, and allows the need to mount as many successive rows of block elements it is necessary to obtain a length of casing (in this case height) Total freely chosen by the manufacturer.

Advantageously, the pillars 31, preferably rigid, joining together the terminal flanges 12, 13 so as to stiffen the site 1.

Said pillars 31 may also advantageously be integral with the anti-perforation walls 10.

Moreover, the crossbars 32 may be either one-piece, that is to say, forming, between two stages corresponding to a horizontal row of block elements (or an annular layer 20), a plate in one piece, such that shown in Figure 8, or form independent elements type tablets corresponding to radial subdivisions of annular plate, for example ring-quarter in Figure 7.

Advantageously, said cross members 32 form Ie or the intermediate flanges.

Preferably, the pillars 31 and / or the cross members 32 are provided with indentations 33 delimited by stop flanges 34, said cavities 33 being adapted to accommodate and hold in position, particularly radially fixed distance relative to the axis generator (XX '), the unit blocks.

Advantageously, as shown in Figure 7, the indentations 33 formed in the pillars 31 may be formed by circular grooves open out centered on the generator axis (XX '), while the crossbars 32 are provided with tongues 35 conjugated form which permits insertion and the free axial movement along said generating axis (XX '), said cross members with respect to the pillars 31, while ensuring the radial locking said sleepers 32.

Thus, a particularly advantageous manner, it is possible to easily assemble the housing 2 by first positioning pillars 31 and by fixing the terminal in a flange 12, 13, then raising between each pair of adjacent pillars of a zone puncture constituted by an alternation of elementary blocks 5 and ties 32 stacked one above the other.

According to another embodiment, the first and / or second elementary block 5, 105 are provided with at least one pin 40 and / or at least one mortise 41 adapted to allow their attachment to each other or to a fixed member housing.

More particularly, as shown in Figures 2, 3 and 4, each elementary block can be provided with two pins 40 projecting respectively from its upper side faces 5LS and lower side 5LL so as to be housed in a mortise 41 conjugated dug into the intermediate flange 21, 22 or in the terminal flange 12, 13 corresponding to block in position said radially elementary block.

Advantageously, the tongue and groove system allows the building blocks self-locking and self-centering feature which facilitates assembly and improves the structural strength of the site 1.

As shown in Figures 1 to 7, the first and second elementary block 5, 105 may be inherently different from each other, that is to say constitute two entities physically and kinematically independent, that can be independently refer to each other on the site 1 during assembly. However, according to an alternative embodiment corresponding to Figure 8, the first and second elementary block 5, 105 are interconnected by a joining strip 50.

Preferably, said joining strip 50 is in the form of a strip whose height, ie measured parallel to the generating axis (XX ') is substantially equal to that of the outer surfaces 5E, 105E, and whose 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 adjacently of 0.5 mm.

Particularly preferably, the joining strip 50 is integral with the first and / or second elementary block 5, 105, and particularly preferably with all of the block elements 5, 105, 205, 305 forming a single annular layer 20.

Preferably, as illustrated in Figure 8, the joining strip 50 forms a peripheral rim which connects the outer surfaces 5E, 105E, 205E, 305E of the block element substantially according to the contour of the base surface 11.

Thus, the joining strip 50 surrounds the unit blocks in a closed contour, and form with said block element a sort of toothed belt intended to be attached to an apertured reinforcement formed of pillars 31.

Advantageously, the lateral surfaces 5L, 105L of two elementary blocks 5, 105 neighbors connected by the same joining strip 50 are spaced apart by a recess 51 whose shape and dimensions correspond substantially to those of the puncture-resistant partition 10 to be inserted between the two blocks.

Advantageously, a sealing strip 50 according to the invention allows on one hand to secure the block elements, and thus simplifying their handling during assembly while improving the stability and overall sturdiness of the housing, and the other hand, thanks to its intrinsic elasticity, exert a centrifugal radial compression force which tends to press the unit blocks against the pillars 31.

Of course, the present invention is likely to be subject to variations, the skilled person being able to assess the number, shape and dimensions of the building blocks, and optionally modular reinforcing elements Type pillars 31 or cross members 32 depending on the size, shape, and destination site 1, 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 for injecting and / or harvesting of fluid substance into a human body or animal and comprising a housing 2 defining a chamber 3 for receiving said fluid substance.

According to an important feature of the invention, said manufacturing method comprises a step (a) assembling a plural puncture area in which is arranged side by side at least a first component block and a second component, made each in a self-sealing material pierceable by the needle, so as to orient their respective outer surfaces 5E, 105E outwardly of the housing 2, their respective internal faces 51, 1051 inwardly of the chamber 3, and least a portion of their respective side faces 5L, 105L substantially vis-vis one another.

Preferably, during step (a) assembly, care is taken to position the outer surface 105E of the second elementary block 105 substantially in the extension of the outer surface 5E of the first elementary block 5.

It is noteworthy that depending on the configuration of the implantable site 1 in accordance with either of the variants described above, step (a) assembling the plural puncture zone may comprise a sub-step ( ai) axial approach during which the first is reported and / or the second elementary block 5, 105 with a host structure, such as a terminal or intermediate flange, in a direction substantially parallel to the generator axis (XX ') of the housing 2.

Specifically, during the sub-step (I) of axial approach, it is reported individually or collectively, the elementary blocks between the pillars 31 and the partitions 10 by threading the "talking over" site 1.

Preferably Ia substep (ai) axially approach is repeated with as many elementary blocks as necessary to obtain a complete annular layer around the generator axis (XX ').

Next, step (a) assembly preferably comprises a sub-step (a2) elevation at which is arranged, preferably by axial approach, at least one elementary block over the one or more block elements already in place.

Where appropriate, a sub-step (a3) ​​of interposition can be implemented between the sub-step (ai) of axial approach and substep (a2) elevation, in which is arranged by above or the building blocks in place one or more cross 32.

Of course, it is possible to chain firstly one or more cycle comprising the substep (ai) axially approach and substep (a2) elevation, so as to build a vertical column by filling the space between two walls 10, alternating Any laying of elementary blocks and ties 32, and then to repeat this cycle to build a neighboring column.

If the website 1 comprises a pre-formed honeycomb structure having the housing intended to accommodate one or more unit blocks, step (a) assembling the plural puncture zone may comprise a sub-step (a4) radial approach during which relate, individually or collectively, one or more block (s) elementary (s) by driving them into the frames in a radial centripetal direction substantially normal to the generating axis (XX ')

Advantageously, in either case, the manufacturing method comprises a step (b) tangentially prestressing concomitantly Preferably in sub-step (ai) of axial approach or (a4) radial approach during which causes compressive deformation of the block elements, is in contact with adjacent elementary blocks, is in contact with bearing surfaces of the anti-perforation walls 10, so as to force the approximation of the left side surface 5LG and right side surface 5LD belonging to a same basic block 5.

It is remarkable that the forcible insertion of basic blocks continues preferably up snapping them at their posts and / or respective mortise. Preferably, Ie manufacturing method also comprises a step (c) axially compressing during which forces the mutual approach of the flanges terminals 12, 13, for example using the pillars 31 such as tie rods, so as to pre also -contraindre the block elements in axial compression.

Moreover, the manufacturing process according to the invention may further comprise a step (d) coupling during which intimately connected two by two elementary blocks neighbors, for example by fusing, at least partially, by chemical, photochemical or thermal their respective side faces located vis-à-vis one another, or by injecting around the block elements and / or between neighboring unit blocks a jointing substance.

Thus, the device according to the invention advantageously has a modular structure which simplifies and standardizes its assembly, while ensuring good sealing and durability of said site.

Advantageously, the implantable site according to the invention has both an optimized accessibility and a small footprint, the components of the puncture area occupying a relatively small volume compared to the total useful volume of the site.

Moreover, it is remarkable that the modular design of the site allows many adaptations of the total length of said website simply by adding additional rows of block elements according to the generating axis (XX ').

Claims

- An implantable medical device (1) for injection and / or drawing fluid substance into a human or animal body and comprising a housing (2) defining a chamber (3) for accommodating said fluid, said device being characterized in that it comprises a drain region (4) plural designed to be pierced by a needle for injecting or puncturing said fluid in said chamber (3), said drain region (4) comprising at least plural a first elementary block (5) and a second block element (105) each formed in a self-sealing material pierceable by the needle and each having an outer face (5E, 105E) extending outwardly of the housing (2), an inner face (51, 1051) facing the inside of the chamber (3), and a side face (5L, 105L) joining the outer face to inner face Ia, said first and second elementary block (5, 105) and ant arranged side by side so as to have at least a portion of their side surfaces (5L, 105L) respective substantially vis-à-vis one another.
- Device according to claim 1 characterized in that the external face (105E) of the second block element (105) is disposed substantially in Ie extension of the outer surface (5E) of the first basic block (5).
- Device according to claim 1 or 2 characterized in that the portions of side surfaces (5L, 105L) of the respective first and second elementary block (5, 105) have substantially matching shapes and extend substantially parallel to the other. 4 - Device according to one of claims 1 to 3 characterized in that the first and second elementary block (5, 105) are immediately juxtaposed so that their lateral faces are in direct contact with one of the other.
5 - Device according to one of claims 1 to 3 characterized in that the first and second elementary block (5, 105) are separated by an anti-perforation partition (10) interposed between portions of their side surfaces (5L, 105L ) located vis-à-vis to each other, said puncture-resistant partition (10) being designed to obstruct the transverse penetration of a needle.
6 - Device according to claim 5 characterized in that the penetration wall (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 - Device according to claim 5 or 6 characterized in that the puncture-resistant partition (10) extends into the chamber (3) so as to form an anti-piercing screen (21) adapted to prevent a needle through the housing from side to side.
8 - Device according to one of the preceding claims characterized in that the first and second elementary block Ie (5, 105) form a puncture area (4) generally convex relative to the exterior of the device (1).
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 generating axis (XX '). - Device according to claim 9 characterized in that the base surface (11) is formed by a disc, a disc portion as an angular sector, a crescent, a half-disk or a neighborhood, an elliptical surface or ellipsoid or a polygonal surface such as a triangle, a rectangle, a square or a hexagon.
- Device according to claim 9 or 10 characterized in that the puncture area (4) extends at least partially on the side wall of the cylindrical housing (2).
- 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 generating axis (XX ') is greater than or equal to 90 °, preferably greater or equal to 180 °, and so particularly preferably greater than or equal to 300 °.
-Dispositif according to one of claims 9 to 12 characterized in that the puncture area (4) comprises a plurality of block elements (5, 105, 205, 305, 405, 505, 605, 705), arranged side by side so as to form an annular layer (20) whose contour corresponds to that of the base surface (11).
- Device according to claim 13 characterized in that it comprises a plurality of annular layers (20, 20A, 20B) superimposed in the direction of the generating axis (XX ').
-Dispositif according to one of the preceding claims characterized in that 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 (e) to enable their attachment to each other or to a fixed member of the housing. - Device according to one of the preceding claims characterized in that the block elements (5, 105, 205, 305, 405, 505, 605, 705) are identical.
- 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 webs (32) independent, said posts and said cross members forming frames in which blocks elementary (5, 105, 205, 305, 405, 505, 605, 705) are embedded.
- Device according to one of the preceding claims characterized in that the first and second elementary block (5, 105) are intrinsically distinct from one another.
- Device according to one of claims 1 to 17 characterized in that the first and second elementary block (5, 105) are interconnected by a joining strip (50).
- Device according to claim 19 characterized in that the joining strip (50) is integral with the first and / or second elementary block (5, 105).
- Device according to claim 13 and one of claims 19 or 20 characterized in that the joining strip (50) forms a peripheral rim joining the outer surfaces (5E 1 105E, 205E, 305E) of block elements (5, 105 , 205, 305) substantially along the contour of the base surface (11).
-Procédé of manufacturing an implantable medical device (1) for injection and / or drawing fluid substance into a human or animal body and comprising a housing (2) defining a chamber (3) for receiving said fluid substance, said manufacturing method being characterized in that it comprises a step (a) assembling a puncture area (4) plural in which is arranged side by side at least a first elementary block (5 ) and a second block element (105), each formed in a self-sealing material penetrable by a needle, so as to orient their respective outer surfaces (5E, 105E) to the outside of the housing (2), their respective internal faces (51, 1051) inwardly of the chamber (3), and at least a portion of their respective side surfaces (5L, 105L) substantially vis-à-vis one another.
PCT/FR2007/001399 2006-09-08 2007-08-24 Implantable site with multifacet septum WO2008029010A1 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
FR0607905A FR2905603B1 (en) 2006-09-08 2006-09-08 implantable site moving shutter.
FR0607905 2006-09-08
FR0701487 2007-03-01
FR0701487A FR2913203B1 (en) 2007-03-01 2007-03-01 implantable site has multiple deflectors
FR0702482A FR2914561B1 (en) 2007-04-05 2007-04-05 implantable site with a screen cams
FR0702482 2007-04-05

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP20070823447 EP2066390A1 (en) 2006-09-08 2007-08-24 Implantable site with multifacet septum

Publications (1)

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

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Application Number Title Priority Date Filing Date
PCT/FR2007/001399 WO2008029010A1 (en) 2006-09-08 2007-08-24 Implantable site with multifacet septum

Country Status (2)

Country Link
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 penetrating screen in the septum
FR2935904A1 (en) * 2008-09-18 2010-03-19 Cie Euro Etude Rech Paroscopie implantable site with septum bidirectional pre-stress

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 penetrating screen 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 bidirectional pre-stress
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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