EP1804898A1

EP1804898A1 - Implantable medical site

Info

Publication number: EP1804898A1
Application number: EP05798603A
Authority: EP
Inventors: Jean-François CHANTRIAUX; Marie-Pierre Marthe D. Chantriaux-De Wazieres
Original assignee: Compagnie Europeenne dEtude et de Recherche de Dispositifs pour lImplantation par Laparoscopie SA
Current assignee: Compagnie Europeenne dEtude et de Recherche de Dispositifs pour lImplantation par Laparoscopie SA
Priority date: 2004-08-19
Filing date: 2005-08-18
Publication date: 2007-07-11
Also published as: US8088112B2; AU2004323123A1; CN101014382A; WO2006021695A1; US20080039772A1; CA2577614A1; BRPI0419150A; EP1796780A1; MX2007001991A; WO2006027425A1; US20080119798A1

Abstract

The invention concerns an implantable device (1) for injecting and/or drawing fluid comprising a housing (2) wherein is provided a chamber (2A), the housing (2) including a proximal wall (4) and a distal wall (5) between which extends a side wall, said housing (2) including an aspiration zone (7) designed to be perforated by a hollow needle for injecting and/or drawing fluid in the chamber (2A). The invention is characterized in that said aspiration zone (7) is configured to extend simultaneously on the proximal wall (4), the side wall and the distal wall (5), said device (1) comprising a shield (13) made of a material not perforable by the hollow needle arranged inside the chamber (2A), so as to prevent the housing (2) from being perforated through and through upon the perforation produced by hollow needle.

Description

IMPLANTABLE MEDICAL SITE

TECHNICAL AREA

The present invention relates to the general technical field of devices intended to be introduced under the skin of a human or animal patient, to be subsequently stitched with a hollow needle, through the skin of the patient, in order to to introduce and / or remove substances from the body of the patient, by limiting repeated skin injuries in the same place. Such devices are generally called implantable sites, or access ports.

The present invention more particularly relates to an implantable device for injecting and / or removing fluid either from an organ or vessel of the body of a human or animal patient, or from an inflatable and / or deflatable compartment of a surgical implant, said device comprising a housing within which is provided a chamber for connection to a catheter, said catheter being itself intended to be connected to said organ or vessel or to said compartment, the housing having a proximal wall and a distal wall between which extends a side wall, said housing comprising a puncture area designed to be pierced by a hollow needle for injecting and / or withdrawing fluid from the chamber.

PRIOR ART

Known implantable sites are generally in the form of a housing having a bottom from which extend lateral walls whose free ends define a proximal opening. The bottom and the side walls are made of a solid and rigid material, such as titanium, to prevent they can be pierced by a needle. The proximal opening is closed by a substantially planar membrane of self-sealing material, thus forming a "septum".

Such devices, if they generally give satisfaction, nevertheless have significant disadvantages.

Thus, these known devices, although relatively bulky and therefore potentially uncomfortable for the patient, offer only a reduced quilting surface, which exposes the risk of damage to the surrounding tissue perforation because the probability of stinging outside the " septum "is far from negligible for the practitioner.

In addition, these known devices are likely to turn under the skin, under the effect of the movements of the patient. In extreme cases, the site can be turned 180 degrees, which completely obscures the "septum". The device thus returned becomes unusable, which requires a new surgical procedure for the installation of a new device.

In order to remedy this problem of turning over the site, it has been proposed to secure the site to the surrounding biological tissues. In order to achieve this fixation, the known devices are provided with holes that will allow their suture to neighboring biological tissues.

Such a solution is however unsatisfactory because it requires a relatively large surgical approach, as well as a longer and more difficult procedure, while increasing the patient's discomfort and the risks of infection. SUMMARY OF THE INVENTION

The objects assigned to the invention therefore aim at proposing a new implantable injection and / or fluid sampling device making it possible to remedy the various disadvantages listed above and facilitating implantation and injection and / or implantation operations. regardless of the orientation of the device under the skin of the patient, without risk of injuring the patient with the needle.

Another object of the invention is to propose a new implantable injection and / or fluid sampling device that allows the practitioner to prick according to a gesture substantially similar to that used when pricking a natural vein.

Another object of the invention is to propose a novel implantable injection and / or fluid sampling device which reduces the risks and drawbacks associated with body movements performed by the patient.

Another object of the invention is to propose a novel implantable injection and / or fluid sampling device which does not need to be sutured to the body of the patient.

Another object of the invention is to propose a new implantable injection and / or fluid sampling device of particularly simple and compact design.

Another object of the invention is to propose a new implantable device for injecting and / or removing particularly light fluid.

Another object of the invention is to provide a new implantable device for injection and / or fluid sampling particularly safe. The objects assigned to the invention are achieved by means of an implantable injection and / or fluid sampling device either in an organ or vessel of the body of a human or animal patient, or in an inflatable compartment and or deflating a surgical implant, said device comprising a housing in which is formed a chamber intended to be connected to a catheter, said catheter being itself intended to be connected to said body or vessel or to said compartment, the housing having a proximal wall and a distal wall between which a side wall extends, said housing comprising a puncture area adapted to be pierced by a hollow needle for injecting and / or withdrawing fluid from the chamber, characterized in that said puncture area is shaped to extend both at least at the proximal wall, the side wall and the distal wall, said device tif comprising a screen made of a material not pierceable by the hollow needle disposed within the chamber, to avoid drilling from one side of the housing during piercing by the hollow needle.

SUMMARY DESCRIPTION OF THE DRAWINGS

Other objects and advantages of the invention will appear better on reading the following description, and with the aid of the accompanying drawings, for purely illustrative and non-limiting purposes, in which:

- Figure 1 illustrates, in a schematic perspective view, a first embodiment of a device according to the invention.

- Figure 2 illustrates, in a schematic perspective view, a second embodiment of a device according to the invention.

- Figure 3 illustrates, in a schematic perspective view, a third embodiment of a device according to the invention. - Figure 4 illustrates, in a schematic perspective view, a fourth embodiment of a device according to the invention.

- Figure 5 illustrates, in a schematic perspective view, a fifth embodiment of a device according to the invention.

- Figure 6 illustrates, in a schematic longitudinal sectional view, a sixth embodiment of a device according to the invention.

- Figure 7 illustrates, in a schematic longitudinal sectional view, a seventh embodiment of a device according to the invention.

- Figure 8 illustrates, in a schematic cross-sectional view, a device according to one or the other of the sixth and seventh embodiments respectively illustrated in Figures 6 and 7.

- Figure 9 illustrates, in a schematic cross-sectional view, an eighth embodiment of a device according to the invention.

- Figure 10 illustrates, in a schematic perspective view, the internal structure of the device shown in Figure 2.

- Figure 11 illustrates, in a schematic side view, a ninth embodiment of a device according to the invention, forming an artificial vein.

- Figure 12 illustrates, in a schematic cross-sectional view, the device shown in Figure 11.

- Figure 13 illustrates, in a schematic cross-sectional view, a tenth embodiment of a device according to the invention. - Figure 14 illustrates, in a schematic cross-sectional view, an eleventh embodiment of a device according to the invention.

- Figure 15 illustrates, in a schematic cross-sectional view, a twelfth embodiment of a device according to the invention.

- Figure 16 illustrates, in a schematic cross-sectional view, a thirteenth embodiment of a device according to the invention.

- Figure 17 illustrates, in a schematic cross-sectional view, a fourteenth embodiment of a device according to the invention.

- Figure 18 illustrates, in a schematic cross-sectional view, a fifteenth embodiment of a device according to the invention.

- Figure 19 illustrates, in a schematic cross-sectional view, a sixteenth embodiment of a device according to the invention.

- Figure 20 illustrates, in a schematic cross-sectional view, a seventeenth embodiment of a device according to the invention.

- Figure 21 illustrates, in a schematic cross-sectional view, an eighteenth embodiment of a device according to the invention.

FIG. 22 illustrates, in a schematic view, the principle of operation of the screen equipping the device illustrated in FIG. 21.

- Figure 23 illustrates, in a schematic longitudinal sectional view, a nineteenth embodiment of a device according to the invention. - Figure 24 illustrates, in a schematic partial side sectional view, a twentieth embodiment of a device according to the invention, the puncture area is being pierced by a hollow needle.

- Figure 25 illustrates, in a schematic cross-sectional view, the device of Figure 24, the hollow needle is not however shown.

- Figure 26 illustrates, in a schematic view in partial longitudinal section, a twenty-first embodiment of a device according to the invention.

BEST MODE OF REALIZING THE INVENTION

The invention relates to an implantable device 1 for injection and / or fluid sampling. Such a device, which could also be referred to as "implantable site", is intended to be implanted, for example surgically, in the body of a patient, and in particular under the skin of said patient, in order to constitute a access port for the introduction or extraction of fluids within the body of said patient, which may be human or animal.

The implantable device 1 according to the invention can be implemented and adapted for different uses.

In the first place, the implantable device 1 according to the invention may be designed for the injection and / or the removal of fluid from an organ or vessel of the body of a patient, and in particular into the venous and / or arterial system. said patient. In this latter application, also known per se, the device 1 according to the invention allows the injection of drugs into a vein or artery. The device 1 according to the invention may also be adapted to supply implanted reservoirs of the insulin pump or analgesic type.

In another particular embodiment, unknown to date in the prior art, the device 1 according to the invention is adapted to form an artificial vein (or artery), which the practitioner, doctor or nurse, can sting to the way of a natural vein to inject a drug substance or take blood.

The implantable device 1 according to the invention may also be adapted for injecting and / or withdrawing fluid into an inflatable and / or deflatable compartment of a surgical implant, and in particular a gastroplasty ring intended for treatment. of obesity.

Such a gastric band is known per se, and is generally formed by a flexible band intended to be closed in a loop around the stomach substantially towards and by its two ends, with the aid of a closure system, to reduce the diameter of the opening of the stoma. Said strip may comprise an annular compression chamber with adjustable volume, connected by a catheter to an implantable device 1 according to the invention, which allows the internal pressure of the chamber to be adjusted in order to adjust the diametrical expansion of the latter.

The device which is the subject of the present invention may, however, be used for the adjustment of other surgical implants, such as, for example, balloons or artificial sphincters.

In what follows, reference will be made more particularly to a hypodermic device, that is to say intended to be positioned just under the skin of the patient. patient. The device according to the invention may, however, be implanted at other locations in the body of the patient, and in a deeper way.

According to the invention, the device 1 comprises a housing 2 in which is formed a substantially sealed and sealed chamber 2A. The chamber 2A, which is delimited by a chamber wall 2B, thus defines an internal volume intended to receive a fluid to be injected and / or taken in the body of the patient. Said chamber 2A is intended to be connected to a catheter 3, said catheter 3 being itself intended to be connected to either the organ or vessel 10 to which it is desired to inject or withdraw fluid (see FIG. inflatable / deflatable compartment of the surgical implant (not shown).

Advantageously, the housing 2 is provided with a guiding means for cooperating with a wire guide to facilitate the introduction of the device 1 under the skin of the patient. Preferably, the guide means (not shown) slidably cooperates with the guide wire, the latter being threaded into said guide means. Even more preferably, the guiding means is formed by a through tunnel formed in the housing 2, over and over the entire length of the latter, for example coaxially with the axis of symmetry of the housing 2. In particular, the housing 2 may comprise a central tunnel for receiving the wire guide and around which is formed the chamber 2A, the latter then having an annular shape.

In accordance with the invention, the housing 2 has a proximal wall 4 and an opposing distal wall 5, between which a side wall 6 extends. By "proximal" is meant in a conventional manner the wall intended to be situated immediately below the skin of the patient, once the device 1 implanted subcutaneously. The housing 2 comprises, in a conventional manner, a puncture zone 7 designed to be pierced by a hollow needle 14, for injecting and / or withdrawing fluid from the chamber 2A.

Advantageously, the puncture zone 7 comprises a self-sealing membrane, made for example of elastomeric material, of the silicone type. Such a membrane has "self-healing" properties. Thanks to these properties, the orifice generated by piercing the membrane with the aid of the needle 14 is automatically re-opened after extraction of the needle 14, which makes it possible to substantially maintain the tightness of the chamber 2A.

According to an important characteristic of the invention, the puncture zone 7 is shaped so as to extend both at least on the proximal wall 4 and the side wall 6, that is to say that the puncture 7 substantially, at least in part, the contour of said proximal walls 4 and lateral 6.

In other words, unlike the devices of the prior art, in which the puncture zone extended over a portion of the proximal wall only, which required a firm suture of the device 1 to the surrounding tissues, the invention proposes a radically opposed concept, which consists in extending the puncture zone 7 to the side wall 6, so as to render unnecessary, or at least not essential, a fixation of the device 1 by suture.

Indeed, in the event of tilting, that is to say of change of orientation, for example under the effect of the movements of the patient, the device 1 according to the invention, the probability that the puncture zone 7 is more accessible is reduced, since said puncture zone 7 extends not only at the level of the proximal wall 4 as in the prior art, but also at the level of the side wall 6. Advantageously, the puncture zone 7 is shaped so as to extend at least at least on the proximal wall 4, the side wall 6 and the distal wall 5, so as to constitute a quilting zone of sufficient size and conformation so that the housing 2 is "piquable" regardless of its angular orientation under the skin of the patient.

In a first embodiment, illustrated in Figure 1, the proximal walls 4, distal 5 and side 6 together contribute to form a substantially polyhedral surface.

More particularly, in the example of FIG. 1, the proximal 4, distal 5 and lateral 6 walls form a rectangular parallelepiped. In this case, the side wall 6 is formed on the one hand of two parallel longitudinal panels 6A, 6B and on the other hand of two parallel transverse panels 6C, 6D, said transverse panels 6C, 6D extending in a substantially perpendicular direction to the direction in which the longitudinal panels 6A, 6B extend.

Advantageously, the catheter 3 is intended to be connected to the chamber 2A at one of the transverse panels 6C, 6D, via a conduit 3A connecting the chamber 2A to the outside of the device 1 and extending longitudinally substantially in the direction of the longitudinal panels 6A, 6B. In this case, the catheter 3 is distinct from the conduit 3A and the housing 2.

it is of course conceivable, without departing from the scope of the invention, that the catheter 3 comes from material with the conduit 3A, so that it forms with the latter a single piece. In this case, the housing 2 and the catheter 3 form a unitary assembly, the catheter 3 being integral with the chamber 2A by construction and not being intended to be disconnected from the housing 2. Advantageously, the puncture zone 7 extends over most or even substantially all of the proximal walls 4, distal 5 and longitudinal panels 6A, 6B. The transverse panels 6C, 6D may of course also constitute the puncture zone 7, although this is not really necessary, given the low risk of tilting of the device 1 around the transverse direction. Thus, all the faces of the casing 2 shown in FIG. 1 can advantageously be used for the puncture, so that an accidental reversal (or simple change of orientation) of the site 1 would not entail any truly awkward consequence for the site. practitioner or patient.

In the following, the variants of FIGS. 2 to 8 will be described in greater detail.

In the various embodiments shown in FIGS. 2 to 8, the duct 3A, which connects the chamber 2A to the outside of the device 1 and which is intended to be connected to the catheter 3, extends longitudinally along a first axis X -X '.

In order to make a reliable mechanical connection between the conduit 3A and the catheter 3, the conduit 3A may be provided with a coaxial bulge 30A (see FIGS. 6 and 7) with a diameter slightly greater than the nominal internal diameter of the catheter 3. The catheter 3, which conventionally has a certain radial elasticity, is thus forced into force on the duct 3A and the bulge 30A, which ensures its maintenance.

It is also possible to grip the catheter 3 on the conduit 3A with the aid of a clamping ring.

Advantageously, the catheter 3 is surrounded, in the vicinity of the duct 3A,

25. a stiffening means 20 (see Figures 1 to 5), constituted for example by a tube or a helical wire 21, the spring kind. Way to ^• stiffening 20, which may also have flexibility in bending, avoids the accidental closure phenomena of the catheter 3 by folding of the latter.

According to the embodiment of FIGS. 2 to 8, the proximal walls 4, distal 5 and lateral walls 6 are shaped and arranged so that the housing 2 has substantially a symmetry with respect to a second axis Y-Y ', said second axis YY' being substantially parallel to the first axis X-X '.

The housing 2 thus has a symmetry of revolution about a second axis YY ', which extends substantially in the same direction as the conduit 3A for connecting the catheter 3. In this case, because of the axial symmetry of the 2, the proximal walls 4, distal 5 and lateral 6 are substantially merged and form a single surface of revolution.

Advantageously, the proximal 4, distal 5 and lateral 6 walls together form a substantially spherical surface, as shown in FIG. 3. In this case, the puncture zone 7 may extend substantially over the all of the proximal walls 4, distal 5 and lateral 6, that is to say on substantially the entire spherical surface. However, without departing from the scope of the invention, it may be provided that the puncture zone 7 extends only over a central circular band of the spherical surface, said circular band being symmetrical relative to the second axis YY ', which is preferably coincident with the first axis X-X '.

In another embodiment, illustrated in Figure 2, the proximal walls 4, distal 5 and lateral 6 together contribute to form a substantially ovoidal surface, extending longitudinally along the axis YY ', in the same direction that the duct 3A. Such an ovoid housing is particularly easy to introduce under the skin of the patient, and particularly well tolerated by the latter.

In the same way as in the case of the spherical casing illustrated in FIG. 3, the puncture zone 7 of the ovoid casing of FIG. 2 can extend substantially over all the proximal walls 4, distal 5 and lateral walls 6, c '. that is to say on the whole of the ovoid surface. But it can also, and this configuration will be preferred, occupy only a central circular band of the ovoid surface, said circular band being symmetrical relative to the second axis YY '.

In the variant shown in FIG. 4, the proximal, distal and lateral walls 6 together form a substantially pear-shaped surface.

Preferably, the conduit 3A for connection to the catheter 3 will be connected to the chamber 2A at the apex of the piriform surface.

Advantageously, the puncture zone 7 may extend substantially over all of the proximal walls 4, distal 5 and lateral 6, or simply occupy a portion of the piriform surface, and for example, as described for the previous variants, occupy a central circular band of axis of symmetry Y-Y '.

In another embodiment, illustrated in particular in Figures 5 to 8, the proximal walls 4, distal 5 and side 6 contribute together to form a substantially cylindrical surface. The puncture zone 7 may extend over substantially all of this cylindrical surface, or only a portion of said surface, in particular a central circular band. Advantageously, the housing 2 corresponding to the embodiment illustrated in Figure 6 comprises a front ring 15 and a rear ring 16, positioned opposite and at a distance from one another, coaxially with the first and second axes X-X ' , Y-Y '. Between the rings 15, 16 is positioned a cylindrical sleeve 17, made of elastomeric material and which forms the puncture zone 7. The conduit 3A is threaded into the front ring 15, centrally relative to the axis YY '.

The front and rear rings 15, 16 may optionally be mechanically connected by spacers (not shown), which would constrain longitudinally in compression the sleeve 17. In order to obtain this pre-stress effect in compression, it would be sufficient to size the sleeve 17 so that it has a length slightly greater than the distance between the front ring 15 of the rear ring 16. The sleeve 17 would then be introduced in force between the two rings, which would create a compression of the elastomeric material according to the axis Y-Y ', which is confused in this case with the axis X-X'.

It is also conceivable, as shown in FIG. 7, that the casing 2 comprises only one distinct ring, namely the front ring 15, the rear ring being made of material with the sleeve 17. can also advantageously provide that the region of the sleeve 17 corresponding to the rear ring 16 is made of an elastomer material different from that in which the rest of the sleeve is made, and having for example a higher hardness.

Advantageously, and whatever the embodiment adopted, the housing 2 according to the invention may be formed of a frame 12 made of a material substantially not pierced by a needle 14, having a certain rigidity (cf. Figure 10). The armature 12 is advantageously covered with an envelope (not shown) made of a self-sealing material, said armature 12 being perforated to form, in cooperation with said casing, the puncture zone 7. More particularly, the armature 12 is designed to give the casing 2 its general shape, in this case a form ovoid for the example shown in Figure 10. This armature 12 serves as a support for an envelope in the form of a substantially elastic pocket, to be threaded, preferably in force, on the frame 12 and marry the general shape of the latter, like a sock. Advantageously, the elastic bag is thus stretched over the armature 12. The casing may advantageously comprise a membrane made of elastomeric material, of the biomedical silicone type.

The armature 12 is perforated, that is to say pierced, at least locally, a series of orifices of sufficient size to allow the needle 14 to pass through. The latter, after having first pierced the envelope, can thus reach the internal volume delimited by the armature 12 and corresponding to the chamber 2A.

Advantageously, the armature 12 is formed of a lattice of rigid material, as shown in FIG. 10. This lattice may, for example, be made using titanium or stainless steel wires. or result from the molding of a plastic material.

In the foregoing there are described housings 2 having a symmetry of revolution about the second axis YY ', itself parallel or coincident with the first axis X-X'. However, it is conceivable, without departing from the scope of the invention, that the housing 2 has no true symmetry of revolution but is simply formed of a curved or left surface, for example of elliptical section, such as that is shown in Figure 9. Advantageously, as shown in Figures 6 to 9, a screen 13, made of a material not pierced by the needle 14, is disposed within the chamber 2A, to avoid drilling from one side of the housing by the needle 14. In other words, the screen 13 is designed to prevent the tip of the needle 14, once it is within the chamber 2A, to continue its course by piercing again the housing 2 and thus protrude out of the housing 2, in the body of the patient.

The screen 13 thus serves as a stop for the needle 14. The screen 13 will in particular be designed according to the conformation of the puncture zone 7, so as to allow effective and safe stitching at any point in this zone. puncture 7.

For the purposes of the invention, the expression "disposed within the chamber" used in relation to the screen 13 must be understood in its most general sense. The invention aims in particular implantable devices provided with a screen 13 which is embedded in the structure of the housing 2 and in particular in the chamber wall 2B, which is advantageously formed by the membrane forming the puncture zone 7.

Advantageously, the screen 13 comprises a finned wheel shaped and positioned so that the fins 13A, 13B, 13C, 13D extend substantially radially around the axis of symmetry YY 'of the housing 2. In particular, as shown in FIG. this is illustrated in Figures 8 and 9, said fins 13A, 13B, 13C, 13D extending radially from a central axis, which itself is preferably coaxial with the axis of symmetry of the housing 2.

Advantageously, the fins are at least four in number, regularly spaced angularly. It is of course conceivable to provide a lower or higher number of fins, or another type of screen 13. The screen 13 is also preferably shaped to allow communication and fluid circulation within the chamber 2A.

For example, in the case illustrated in Figures 8 and 9 where the screen 13 is formed by a wheel with four flat fins 13A, 13B ₁ 13C, 13D, the four compartments defined in the chamber 2A, by said fins 13A , 13B, 13C, 13D will not be waterproof and will all be in fluid communication, even indirectly, with each other. For this, we can for example size the size of the fins so that they do not marry the walls of the housing 2.

The screen 13 may float freely within the chamber 2A or possibly be held in position by means of an ad hoc fixing system. Said fixing system may for example comprise centering shafts 13E, 13F (see FIG. 6) cooperating with complementary housings formed within the housing, so as to hold the finned wheel in position, while possibly allowing it to rotate around the Y-Y 'axis.

Advantageously, the finned wheel forming the screen 13 is rotatably mounted within the chamber 2A. Thus, as shown in FIG. 13, the finned wheel may preferably comprise a rotation shaft 13G, extending coaxially with the axis of symmetry of the housing 2 and the puncture zone 7, axis 13G from which extend two curved flaps 13H, 131 diametrically opposite relative to the axis 13G. Of course, it may be implemented a number of curved flaps 13H, 131 greater than two, without departing from the scope of the invention.

In another embodiment, of which three sub-variants are illustrated 14 to 16, the screen 13 advantageously comprises at least one abutment panel 18A-18G for the hollow needle 14, mounted slidingly against the chamber wall 2B ₁ such that said panel 18A-18G can be moved within the chamber 2A under the effect of a thrust exerted by the hollow needle 14 towards the inside of the chamber 2A, during the puncture operation.

In other words, the technical principle underlying the embodiments of FIGS. 14 to 16 lies in the implementation of a "global" displacement of the screen 13, under the effect of the force exerted by the needle 14 when it abuts against the screen 13, the displacement of the latter being guided by sliding support of the panels 18A-18G on the wall 2B of the chamber 2A.

In the variant of Figure 14, the screen 13 comprises two abutment panels 18A-18B preferably having a similar curved shape, said panels being symmetrically disposed in a substantially Y-shaped or V-shaped, each of the three ends of said Y or V being connected to a corresponding slider 19A-19C, said slider abutting sliding against the wall 2B of the chamber 2A. The panels 18A, 18B and their associated pads 19A-19C thus form a unitary assembly guided in rotation within the chamber 2A.

The displacement of the screen 13 according to variant 14 is thus controlled and can only be performed according to one or more predetermined degrees of freedom.

In this particular embodiment, the invention is of course not limited to a V-shaped or Y-shaped screen, and the panel or panels may for example form an S (see panel 18C of FIG. or a W (see panel 18D, 18E, 18F, 18G of FIG. 16).

In the case of the variant of Figure 15, the screen 13 is preferably formed of a single panel 18C doubly curved to form an S, each of the ends of the S being provided with a sliding shoe 19D, 19E corresponding, bearing on the wall 2B.

In the variant of Figure 16, the screen 13 is formed of four planar panels 18D, 18E, 18F, 18G interconnected accordion to form a W, each of the vertices W being provided with a corresponding slider 19F- 19J designed to slide against and along the wall 2B of the chamber 2A.

Of course, the variant of FIGS. 14 to 16 is not limited to a particular number or shape of a panel, nor to a specific number or shape of slider, which may have a rounded shape. as is the case in the variants of Figures 15 and 16, or rather a spatula shape, as is the case in the variant of Figure 14.

In the variants of Figures 14 to 16, the panels 18A-18G preferably have a substantially rigid character, and are designed so that the needle 14 can obviously not pierce them.

In another embodiment of the invention, two sub-variants of which are illustrated in FIGS. 17 and 18, the screen 13 comprises at least one abutment panel 18H-18O for the hollow needle 14, preferably arranged opposite and in the vicinity of the chamber wall 2B, said at least one 18H-18O panel being deformable under the effect of a thrust exerted by the hollow needle 14.

In other words, in this embodiment illustrated in FIGS. 17 and 18, the panels constituting the screen 13 do not move under the effect of the support exerted by the hollow needle (as was the case in the variant previously described), but deform under the effect of this support. In particular, as shown in FIG. 17, the screen 13 may comprise four 18H-18K panels affixed relative to each other to cover the entire wall surface 2B that may be pierced by the needle. 14. In this case, each panel has substantially in cross section, a quarter-circle profile, so that the combination of the four panels has a substantially circular contour, corresponding to the circular contour of the chamber section 2A.

As shown in FIG. 17, under the effect of the thrust exerted by the needle 14, the panel 18H will deflect inwardly of the chamber 2A, to reach a deformed configuration 18B (shown in dashed line on FIG. Figure 17).

Preferably, each panel 18H-18K is deformable in flexion. Of course, it is entirely conceivable, without departing from the scope of the invention, that the panels 18H-18O work in another mode of deformation, for example in compression or traction.

It is also conceivable that each panel 18H-18O comprises a plurality of substantially rigid unit elements interconnected by flexible links to form the panel. In this case, the deformation of the panel is not obtained by the intrinsic deformation characteristic of the material forming the panel, but by displacement of the rigid unit elements.

Advantageously, as shown in FIG. 18, the panels 18L-18O may have a curved preform towards the inside of the chamber 2A. It is also quite possible, as illustrated in FIG. 17, for the screen 13 to be freely disposed within the chamber 2A, or on the contrary that it be fastened locally to the wall 2B of said chamber 2A. as shown in Figure 18.

In the latter case, each panel is fixed to the wall 2B of the chamber 2A via two associated fastening lines 20A-20D, each fastening line 20A-20D being common to two panels, in the case where four panels are implemented, as shown in Figure 18.

Advantageously, as shown in FIG. 20, the screen 13 comprises a flexible membrane 21 whose shape is substantially conjugate to that of the chamber wall 2B _1, said membrane 21 being freely disposed within the chamber 2A and being deformable under the effect of a thrust exerted by the hollow needle 14.

In the case, illustrated in Figure 20, where the puncture zone 7 has substantially an ovoid shape, as illustrated in Figure 2, the membrane 21 also has a substantially ovoid conjugate shape, which substantially matches the contour of the wall 2B.

Advantageously, said membrane 21 may delimit a closed volume, and in this case forms a flexible pouch. The membrane 21 is made of a flexible and flexible material, but strong enough not to be pierced by the needle 14.

Advantageously, the membrane 21 has a shape memory, that is to say that it is designed to find automatically and without external stress its normal configuration in which its shape is substantially conjugated to that of the wall 2B, after it has been deformed by the thrust exerted by the needle 14.

Preferably, the membrane 21 is made by weaving a substantially rigid material, such as a metal or a hard plastic for example.

In a particularly preferred manner, the membrane 21 consists of a chain of metal mesh, the mesh size being chosen to prevent the passage of a hollow needle 14.

In a particularly preferred manner, as shown in FIG. 20, the membrane 21 floats freely within the chamber 2A, that is to say that it is not constrained in a predetermined position.

Advantageously, and as is obviously the case in the case of a membrane made of chain mail, said membrane 21 has a character sufficiently porous to allow the circulation of fluid throughout the chamber 2A.

Of course, it is conceivable that the membrane 21 has an impermeable character and is attached to the wall 2B ₁ without departing from the scope of the invention.

In another embodiment illustrated in FIG. 19, the screen 13 advantageously comprises a plurality of particulate elements 22 freely disposed within the chamber 2A, said particulate elements 22 being sufficient in number for the introduction of the hollow needle 14 in the chamber 2A generates, at least locally, the mutual blocking of the particulate elements 22, which thus form together a stop for the needle 14, stopping the latter in its progression.

In other words, the number of particulate elements 22 is chosen so that said particulate elements occupy substantially all of the available volume in the chamber 2A, except for a fraction of volume corresponding approximately to the volume of the chamber. needle 14.

Thus, in the absence of the needle 14 within the chamber 2A, each particulate element 22 can move with a certain degree of mobility, whereas when the needle 14 is introduced into the chamber 2A, substantially all of the available volume of the chamber 2A is occupied, which has the effect of locking in position relative to each other the particulate elements 22, which thus prevent any progression of the needle 14 which could lead to a piercing through and through the puncture zone 7.

Advantageously, the particulate elements 22 have substantially a spherical shape, it being understood that the invention is not limited to a specific form of particulate elements, which could also be polygonal, for example.

Advantageously, the particulate elements 22 are made of a rigid and resistant material, such as a hard plastic or a metal.

In another embodiment, of which four sub-variants are illustrated in FIGS. 20 to 26, the screen 13 has a first face 23 disposed opposite the chamber wall 2B and a second opposite face 24. Said first face 23 is provided with access means 25 allowing the hollow needle 14 to pass through the screen 13 in the direction of the first face 23 towards the second face 24, so that the hollow needle 14 can completely cross the screen 13, while the second face 24 is provided with locking means 26 to prevent the needle 14 to pass through the screen 13 in the direction of the second face 24 to the first face 23 .

In other words, the screen 13 of the embodiments shown in Figures 20 to 26 is pierced exclusively in a single direction, from its outer face to its inner face.

With this technical measure, it is thus sufficient to position, as is particularly illustrated in Figure 22, two portions 130, 131 of screen 13 facing one another, so that their respective second faces 24 vis-à-vis.

In this case, the needle 14 may completely completely pass through one of the two screen portions 130 in the direction of its first face 23 towards its second face 24, but will be blocked against the second face 24 of FIG. the second portion 131 of screen 13, since said second face 24 is provided with locking means preventing the needle 14 from passing through the screen 13 in the direction of the second face 24 towards the first face 23.

This embodiment is therefore particularly well suited to a puncture zone 7 extending 360 ° on the housing 2, since it is sufficient in this case to line the inner wall 2B of the chamber 2A with the screen 13 (cf. Figure 21) to obtain the desired "smart shield" effect.

The invention corresponding to the embodiment of Figures 20 to 26 is based on a partial piercing of the screen 13, said screen 13 being provided with a first face 23 pierceable and a second face 24 opposite non-pierceable. In the variant embodiment illustrated in FIG. 21, the screen 13 advantageously comprises a series of unitary elements 27 arranged side by side and resiliently biased against each other. The elements 27 thus together form an elastically deformable sheet. The unit elements 27 are each made of a sufficiently strong material not to be pierced by the needle 14. In particular, each unit element 27 preferably has a rigid character.

The unit elements 27 cooperate to define between each of them, and opposite the chamber wall 2B, a corresponding convergent path 27A for the hollow needle 14, so that the insertion of the hollow needle 14 into a Convergent path 27A will lead, as illustrated in Figure 22, to the relative spacing of the corresponding elements 27, thus allowing the passage of the needle 14 to and into the chamber 2A.

The set of convergent paths 27A thus form the first face 23 of the screen 13, that is to say the face allowing insertion and passage of the needle 14.

According to the embodiments of Figures 21 and 22, the elements 27 also cooperate to define between each of them, opposite the convergent path 27A, an obstacle 27B to the passage of the needle 14 between them. The set of obstacles 27B thus forms the second face 23, second face 23 which substantially prevents any penetration of the needle 14 into and through the screen 13.

Preferably, as shown in FIG. 21, the unit elements 27 have a substantially triangular shape in cross section and are elastically connected together to form a circular base cylindrical sheet, conjugated to the cylindrical shape of the wall chamber 2B, wall 2B in which extends continuously the puncture zone 7.

Each unit element 27 of triangular section has, in cross section, a base from the ends of which extend two sides joining in a vertex. The triangular elements 27 are elastically connected to each other so that the bases of each of the elements 27 are in continuity with each other, and thus form a substantially smooth and uniform surface. This smooth and uniform surface constitutes the second face 24, second face 24 which by its smooth and solid character does not allow the needle 14 to clear a passage between the triangular elements 27.

In contrast, the sides of the triangles extending from the base define two by two interstitial spaces of substantially triangular shape in cross section, each interstitial space converging towards the interior of the chamber 2A.

The needle 14, when introduced and pushed into one of the interstitial spaces forming convergent path 27A is thus able to move the elements 27 to clear a path to the interior of the chamber 2A . The needle 14 can not, however, pierce the membrane 7 again, since it will be stopped in the path by the second face 24, as shown in FIG. 22.

Advantageously, the base of each triangle will have a conformation to improve the obstacle effect of the second face 24.

For example, as shown in Figure 22, the base of each member 27 may include a lug 27B at one end thereof; that the other end has an evident 27C of complementary shape to that of the pin 27B, so as to make a nesting of the triangular elements 27 in each other. Such an engagement, illustrated in FIG. 22, increases the reliability of the obstacle function provided by the second face 24.

According to another variant of which two sub-embodiments are illustrated in FIG. 23 on the one hand and in FIGS. 24 to 25 on the other hand, the screen 13 comprises a plurality of tubular elements 28 each having a substantially convergent shape , said elements 28 are preferably all substantially identical and made of a material not pierceable by the hollow needle 14, preferably substantially rigid.

The elements 28 are threaded into each other, so as to form a substantially tubular structure having an outer face, forming the first face 23, and an inner face, forming the second face 24.

Preferably, as shown in FIG. 23, each element 28 is in the form of a frustoconical ring.

In the embodiment of FIG. 23, the elements 28 are held in position relative to each other by means of a connecting wire 29, for example in the form of a flexible cord, fastened to each element 28.

It is of course conceivable to implement other means for maintaining the position of the elements 28, and for example the implementation of two flanges located at each end of the stack of elements 28. In the variant of Figure 23, the stack of elements 28 is freely disposed within the chamber 2A, the dimensions of the stack being chosen, however, relative to those of the chamber 2A so that said stack is substantially adjusted within of the chamber 2A, and can take only an orientation coaxial with that of said chamber.

It is of course conceivable, without going beyond the scope of the invention, that the tubular elements 28 are fixed in position within the chamber 2A, for example being connected to the end piece 3A intended to be connected to the catheter 3.

It is also conceivable that the membrane 7 forming the chamber wall 2B is directly overmolded on the stack of tubular elements 28, or simply bonded by bonding to said stack.

It is also possible, as illustrated in FIG. 24, to provide a tubular sleeve 30 disposed within the chamber 2A coaxially with the latter, the elements 28 being threaded and held onto said tubular sleeve 30, which may be preferably made of a material pierced by the hollow needle, such as silicone.

The operation of this embodiment is as follows.

The needle 14, after having passed through the puncture membrane 7, can slip into the interstitial space existing between two tubular elements 28, an interstitial space favored by the convergent shape of each of the tubular elements. The needle 14 then passes through the sleeve 30 (if such a sleeve is provided) and arrives within the chamber 2A, which then makes it possible to perform the desired operation of injection or aspiration of fluid. In the event that the needle 14 continues its course, it would abut against the face 24, in an orientation preventing the needle from passing beyond the screen 13 and pierce the membrane 7. In fact, The stitching direction of the needle 14 is controlled by the convergent orientation of the elements 28, convergent orientation which forces the needle 14 to adopt an oblique path, substantially parallel, with the clearance, to the conformation of the elements 28. However, as is particularly visible in FIG. 24, the stitching orientation of the needle 14, controlled by the first face 23, prevents said needle 14 from sliding in an interstitial interstitial space 28 at the level of the second face 24, since the interstitial interstitial spaces of the second face 24 have an orientation which is symmetrical to that of the orientation of the needle 14 relative to the axis of symmetry of the chamber 2A.

Of course, the invention is not limited to the implementation of tubular elements, but more generally aims at the implementation of two oblique stacks of blades arranged symmetrically within the chamber 2A, the first stack forming the face 23 and allowing the passage of the needle 14 in a predetermined oblique direction, while the second stack is blocking the trajectory of the needle.

The invention is therefore based, as far as this embodiment is concerned, on the internal (or internal) lining of the puncture zone 7 by a series of scales, said scales allowing the passage of the needle exclusively in one direction. predetermined.

According to an alternative embodiment of the invention, illustrated in FIG. 26, the screen 13 advantageously comprises a plurality of lamellae 31 arranged so as to partially overlap each other, in substantially a tubular outline having an external face, forming the first face 24, and an inner face forming the second face 23. By Therefore, the general technical principle underlying this embodiment is similar, or at least very similar, to that implemented in the variants of FIGS. 23 to 25, since it is again based on the realization of a system with scales, said scales being in this case formed by lamellae substantially not pierceable by the hollow needle 14. Said lamellae are preferably rigid, and for example made of a metal of the steel or titanium type.

In particular, each lamella 31 will advantageously consist of a foil ribbon.

The slats 31 are arranged so as to partially overlap each other, so as to define, as in the variants of Figures 23 and 24, a passage path for the needle 14, in a predetermined oblique direction, direction incompatible with the penetration by the needle of the second face 24.

It is of course conceivable, without departing from the scope of the invention, for the screen 13 of the previously described variants illustrated in particular in FIGS. 17, 18 and 20 to 26 to be integrated wholly or partly directly within the chamber wall 2B. In other words, in this case, the elements forming the screen 13 are advantageously embedded in the structure of the wall 2B, which is preferably directly formed by the "septum" membrane forming the puncture zone 7. Technical measure may in particular be used to maintain in position relative to each other the elements forming the screen 13, without additional means, such as the rope 29 or the sleeve 30, is necessary. Preferably, in the case where the elements forming the screen 13 are embedded in the puncture membrane, said elements will be embedded at a distance from the surface of the wall 2B sufficiently small so that when the hollow needle 14 is in abutment against the screen 13, its internal orifice, which classically debouches beveled at the tip of the needle, is not closed and opens into the chamber 2A.

Of course, the use of a screen 13 is purely optional.

The embodiment shown in FIGS. 11 and 12 will now be described in greater detail, and which concerns a hypodermic device 1 for injecting a drug into a vein 11 (or artery) and / or collecting blood in said vein 11 (or artery), said device 1 thus forming a vein or artificial artery.

The device 1 according to this embodiment aims to faithfully mimic a natural vein, in order to substitute it for intravenous injection of medical products or blood collection operations.

To this end, the device 1 substantially reproduces the geometry of a portion of natural vein, that is to say that it is in the form of an elongated tubular housing, made for example integrally of a pierceable material, like silicone.

The device 1 thus constituted is intended to be flush with the skin of the patient, above the vein 11 to which it is connected.

The device 1 according to this embodiment is intended to be stitched in the manner of a natural vein, that is to say at a grazing angle relative to the skin of the patient, and not perpendicularly, as in the case of stitching of a site of the prior art. Such a "tangential" stitching does not fundamentally necessitate the presence of a screen 13. However, such a screen may be considered, as is the case for the variant of Figures 11 and 12.

In this variant, the distal wall 5 is substantially planar and is delimited laterally by two lateral edges 5A, 5B, while the proximal wall 4 and the lateral wall 6 together form a surface of revolution, for example a semicircular, connecting said side edges 5A, 5B.

The screen 13 is in turn consists of a gutter, made of a material not pierced by the needle 14, but preferably having a flexible character. Said gutter advantageously has a cross-section in "U", the soul of the "U", resting in the chamber 2A on the distal wall 5, while the arms of the "U" rise against the side wall 6.

The concept of artificial vein developed in the context of the present invention has a character totally independent of the other applications mentioned in the foregoing.

Finally, it will be noted that the housing 2 may advantageously have a radio-opaque character, by the inclusion, in its internal structure, in a uniform manner or not, of a suitable marking substance.

POSSIBILITY OF INDUSTRIAL APPLICATION

The invention finds its industrial application in the production and use of implantable sites for injection and / or fluid sampling.

Claims

1 - Implantable device (1) for injecting and / or sampling fluid either in an organ or vessel of the body of a human or animal patient, or in an inflatable and / or deflatable compartment of a surgical implant, said device (1) comprising a housing (2) in which is formed a chamber (2A) intended to be connected to a catheter (3), said catheter (3) being itself intended to be connected to said organ or vessel or in said compartment, the housing (2) having a proximal wall (4) and a distal wall (5) between which a side wall (6) extends, said housing (2) comprising a puncture zone (7) designed to be able to being pierced by a hollow needle (14) for injecting and / or withdrawing fluid from the chamber (2A), characterized in that said puncture zone (7) is shaped so as to extend at a time at least on the proximal wall (4), the side wall (6) and the distal wall (5) , said device (1) comprising a screen (13) made of a material not pierceable by the hollow needle (14) disposed within the chamber (2A), in order to avoid piercing from one side of the housing (2 ) during piercing by the hollow needle (14).

2 - Device (1) according to claim 1 characterized in that the distal wall (5) is substantially planar and is delimited laterally by two lateral edges (5A, 5B), while the proximal wall (4) and the lateral wall ( 6) contribute to forming together a surface of revolution connecting said lateral edges (5A, 5B). 3 - Device (1) according to claim 1 characterized in that the proximal walls (4), distal (5) and lateral (6) together to form a substantially polyhedral surface.

4 - Device (1) according to claim 1 characterized in that it comprises a duct (3A) connecting the chamber (2A) to the outside of the device, said duct (3A) extending longitudinally along a first axis (X -X ') and being intended to be connected to said catheter (3), the proximal (4), distal (5) and lateral (6) walls being shaped and arranged so that the housing (2) has substantially symmetry with respect to a second axis (YY), said second axis (Y-Y ') being substantially parallel to the first axis (X-X').

5 - Device (1) according to claim 4 characterized in that the proximal walls (4), distal (5) and lateral (6) together form a substantially spherical surface.

6 - Device (1) according to claim 4 characterized in that the proximal walls (4), distal (5) and lateral (6) together to form a substantially ovoidal surface.

7 - Device (1) according to claim 4 characterized in that the proximal walls (4), distal (5) and lateral (6) together to form a substantially pear-shaped surface.

8 - Device (1) according to claim 4 characterized in that the proximal walls (4), distal (5) and lateral (6) together to form a substantially cylindrical surface. - Device (1) according to one of claims 1 to 8 characterized in that the puncture zone (7) extends substantially over the whole of the proximal walls (4), lateral (6) and distal (5).

- Device (1) according to one of claims 1 to 9 characterized in that the puncture zone (7) comprises a self-sealing membrane.

-Dispositif (1) according to one of claims 1 to 10 characterized in that the housing (2) is formed of a frame (12) made of a material substantially not pierceable by the hollow needle (14) and covered by at least one envelope made of a self-sealing material, said armature (12) being perforated to form, in cooperation with the envelope, the puncture zone (7).

- Device (1) according to claim 11 characterized in that the armature (12) is formed of a lattice (12A) substantially rigid.

- Device (1) according to one of claims 1 to 12 characterized in that the screen (13) comprises a finned wheel (13A, 13B, 13C, 13D).

-Dispositif (1) according to claim 13 characterized in that the fins (13A, 13B, 13C, 13D) are at least four in number, evenly spaced anguiairement.

- Device (1) according to one of claims 13 and 14 characterized in that the finned wheel is rotatably mounted within the chamber (2A).

-Dispositif according to one of claims 1 to 12 characterized in that the chamber being delimited by a chamber wall, the screen (13) comprises at least one stop panel for the hollow needle (14) mounted in sliding support against the chamber wall, so that said panel can be moved within the chamber under the effect of a thrust exerted by the hollow needle (14).

17 - Device according to one of claims 1 to 12 characterized in that the chamber being delimited by a chamber wall, the screen (13) comprises at least one abutment panel for the hollow needle (14), said panel being deformable under the effect of a thrust exerted by the hollow needle (14).

18 - Device according to claim 17 characterized in that said panel is deformable in bending.

19 - Device according to one of claims 17 and 18 characterized in that the panel comprises a plurality of substantially rigid unit elements interconnected by flexible connections to form the panel.

20 - Device according to one of claims 1 to 12 characterized in that the screen (13) comprises a flexible membrane whose shape is substantially conjugated to that of the chamber wall, said membrane being freely disposed within the chamber and being deformable under the effect of a thrust exerted by the hollow needle (14).

21 - Device according to claim 20 characterized in that said membrane has a shape memory.

22 -Dispositif according to one of claims 20 and 21 characterized in that said membrane is made by weaving a substantially rigid material.

23 - Device according to one of claims 1 to 12 characterized in that the chamber (2A) being delimited by a chamber wall, the screen has a first face disposed facing the chamber wall and a second opposite face, said first face being provided with access means allowing the hollow needle (14) to pass through the screen (13) in the direction of the first face to the second face, while the second face is provided with locking means to prevent the needle (14) to pass through the screen (13) in the direction of the second to the first face.

- Device according to claim 23 characterized in that in that the screen (13) comprises a series of unitary elements arranged side by side and resiliently biased against each other, said elements cooperating to define between each of them and in view of the chamber wall a corresponding convergent path for the hollow needle (14), so that the introduction of the hollow needle (14) in a convergent path will lead to the relative spacing of the corresponding elements, allowing thus the passage of the needle (14) towards and in the chamber (2A), the set of convergent paths forming the first face, the unitary elements also cooperating to define between each of them, opposite to the convergent path , an obstacle to the passage of the needle between them, the set of obstacles forming the second face.

- Device according to claim 23 characterized in that in that the screen (13) comprises a plurality of tubular elements of substantially convergent shape, threaded into each other so as to form a substantially tubular structure having an outer face , forming the first face, and an inner face, forming the second face.

- Device according to claim 23 characterized in that in that the screen (13) comprises a plurality of slats arranged so as to partially covering each other, substantially along a tubular contour having an outer face, forming the first face, and an inner face, forming the second face.

- Device according to one of claims 1 to 12 characterized in that the screen (13) comprises a plurality of particulate elements freely disposed within the chamber (2A), said particulate elements being sufficient in number that the introduction of the hollow needle (14) into the chamber (2A) generates, at least locally, the mutual blocking of the particulate elements, which together form a stop for the needle (14).

- Implantable device (1) for injecting and / or withdrawing a fluid into an inflatable and / or deflatable compartment of a gastroplasty ring, according to one of claims 1 to 27.

- Implantable device (1) for injecting a drug into a vein or artery (11) and / or withdrawing blood into said vein or artery (11), thereby forming an artificial vein or artery, in accordance with one of claims 1 to 27.