EP2077887A2

EP2077887A2 - Compact linear implantable site

Info

Publication number: EP2077887A2
Application number: EP07823394A
Authority: EP
Inventors: Marc José ESTEVE
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: 2006-08-03
Filing date: 2007-08-03
Publication date: 2009-07-15
Also published as: WO2008015346A2; FR2904563A1; WO2008015346A3; CN101500641A; FR2904563B1; JP2009545353A; US20100063461A1

Abstract

The invention concerns an implantable device (1) for injecting and/or drawing fluid, said device comprising a chamber (2) extending between a puncture area (3) and an outlet (4) located opposite said puncture area (3), said device (1) being characterized in that it has a shape which is substantially elongated along a longitudinal axis (XX'), in that the puncture area (3), the chamber (2) and the outlet (4) are substantially aligned along said longitudinal axis (XX'), and in that it comprises an interposing means (12) which projects into the chamber (2) so as to prevent the needle (5), which enters said chamber (2) through the puncture area (3), from reaching the outlet (4). It also concerns implantable sites.

Description

COMPACT LINEAR IMPLANTABLE SITE

TECHNICAL AREA

The present invention relates to the general technical field of devices intended to be surgically 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 in the body of the patient while limiting trauma, including skin, related to the repetition of bites.

Such devices are generally called "implantable sites".

The present invention more particularly relates to an implantable device intended for the injection and / or sampling of fluid in a human or animal body, said device comprising a chamber extending between a puncture zone, designed to be pierced by a needle for injecting and / or withdrawing fluid, and an outlet port opposite said puncture area and for communicating said chamber with a conduit such as a catheter, said chamber being shaped to accommodate the needle.

The present invention also relates to a system comprising an implantable device according to the preceding paragraph.

PRIOR ART

It is known to use implantable devices to provide direct parenteral access to any part of the body (organ, vessel, cavity ...) in order to perform, iteratively, the admission of nutrients or drugs, blood samples, or drainages.

Generally, a system consisting of an elastomeric tubing connected at one of its ends to an implantable site in the form of a sealed housing comprising at least one chamber intended to receive is used for this purpose. the fluid punctured or injected. Said chamber is closed with a self-healing wall, or "septum", which forms a puncture area capable of being pierced repeatedly by a hollow needle without losing its seal.

Usually, the site is implanted under the skin of the patient while the second end of the elastomeric tubing is placed in the organ, cavity or vessel at which fluid diffusion or removal is to be achieved. Thus, the practitioner has a remote access path to said organ. The skin barrier surrounding the site advantageously limits the risks of infection related to the multiplication of punctures.

The known implantable sites, however, suffer from significant disadvantages.

First, the effective area of the puncture area is generally low compared to the overall size of the site.

The restricted nature of this useful surface frequently makes it difficult for the practitioner to locate the puncture site, which is a source of discomfort or pain for the patient since the puncture is poorly performed or obtained only after several unsuccessful attempts. In addition, the large size of the site itself is a physical and aesthetic discomfort obvious that the implant visibly deforms the skin of the patient.

Furthermore, the arrangement of the sites of the prior art and the small space available for the approach and the maneuver of the needle frequently lead the practitioner to abut the bevel of said needle against a rigid internal obstacle at the site, such as a metal wall. However, if the bevel of the needle is, for example horny or obscured during a contact pressed or brutal against a hard obstacle, it is likely to cause degradation of the septum during the extraction of the needle and thus compromising the watertightness of the site prematurely.

Finally, the implantable sites of the prior art generally consist of a large number of mechanical parts, which makes their assembly complex and tends to give them a superfluous footprint while maintaining their manufacturing cost at a high level.

SUMMARY OF THE INVENTION

The objects assigned to the invention are therefore intended to remedy the various disadvantages listed above and to propose a new implantable device for injecting and / or sampling fluid in an organism that is particularly simple and compact design while guaranteeing reliability and operational safety.

Another object of the invention is to propose a novel implantable device presenting only a minimal physical or aesthetic discomfort for the patient. Another object of the invention is to propose a new implantable device whose cost is optimized.

Another object of the invention is to propose a new implantable device that offers good ergonomics and is easy to implement by the practitioner, both during implantation and use, and in particular that is easily identifiable after its implantation and allows the stitching as a natural gesture for the practitioner.

The objects assigned to the invention are also intended to propose a new system comprising an implantable device for injecting and / or sampling fluid in an organism that is particularly simple, compact design and safe use.

The objects assigned to the invention are finally intended to propose a new system comprising an implantable device for injecting and / or sampling fluid in an organism that has an optimized life.

The objects assigned to the invention are achieved by means of an implantable device intended for the injection and / or sampling of fluid in a human or animal body, said device comprising a chamber extending between a puncture zone. , adapted to be pierced by a needle for injecting and / or withdrawing fluid, and an outlet port opposite said puncture area and for communicating said chamber with a conduit such as a catheter, said chamber being shaped to receive the needle, said device being characterized in that it has a shape substantially elongated along a longitudinal axis, in that the puncture zone, the chamber, and the orifice of output are substantially aligned in the direction of said longitudinal axis, and in that it comprises an interposing means projecting into the chamber to prevent the needle entering said chamber through the puncture area from reaching the exit port.

The objects assigned to the invention are also achieved by means of a system comprising an implantable device according to the invention and comprising a catheter connected to said device so that the chamber communicates with said catheter through the outlet orifice. .

SUMMARY DESCRIPTION OF THE DRAWINGS

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

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

- Figure 2 illustrates, in a cross section A-A, the device of Figure 1.

- Figure 3 illustrates, in a longitudinal section, a second embodiment of a device according to the invention.

FIG. 4 illustrates, in cross-section B-B, the device of FIG. 3.

FIGS. 5a and 5b illustrate, in partial cut-away perspective views, an alternative embodiment of interposition means that can be implemented within a device according to the invention, respectively before and after setting contact of a needle against said interposing means. - Figure 6 illustrates, in a longitudinal section, a third embodiment of a device according to the invention.

FIG. 7 illustrates, in a cross-section C-C, the device of FIG. 6.

- Figure 8 illustrates, in a cross section D-D, the device of Figure 6.

- Figure 9 illustrates, in longitudinal section, a fourth embodiment of a device according to the invention.

- Figure 10 illustrates, in a longitudinal section, a fifth embodiment of a device according to the invention.

- Figure 11 illustrates, in a longitudinal section, a sixth embodiment of a device according to the invention.

- Figure 12 illustrates, in a cross section E-E, the device of Figure 11.

- Figure 13 illustrates, in a longitudinal section, a seventh embodiment of a device according to the invention.

- Figure 14 illustrates, in a cross section G-G, the device of Figure 13.

- Figure 15 illustrates, in a cutaway perspective views, an eighth variant embodiment of a device according to the invention. - Figure 16 illustrates, in a perspective view, a variant of a system according to the invention comprising a device according to the invention which is connected to a catheter.

- Figure 17 illustrates, in an overall view with partial sections, another variant of a system according to the invention comprising a device according to the invention which is connected to a catheter.

BEST MODE OF REALIZING THE INVENTION

The invention relates to an implantable device 1 for injecting and / or sampling fluid in a human or animal body.

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

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 a vessel of the body of a patient, and in particular into the venous or arterial system of said patient, for example to allow the injection of drug substances into a vein or artery. According to a particular variant of this application, said device 1 can be adapted to form an artificial vein or artery that the practitioner can prick through the skin, in the manner of a natural vein, in order to inject a therapeutic substance or take blood. The device 1 according to the invention can also be adapted to supply implanted reservoirs associated for example with insulin or analgesic pumps.

The implantable device 1 according to the invention can also be adapted for the injection or the puncture of fluid in the inflatable or deflatable compartment of a surgical implant, such as an artificial sphincter, a balloon or a gastric ring intended for achieve a constriction of the stomach to fight against obesity.

In what follows, it will be more particularly considered that the device 1 according to the invention is a hypodermic device, that is to say, it is intended to be positioned just under the skin of the patient.

Said device 1 may however be implanted at other locations in the body of the patient and in a deeper way, without departing from the scope of the invention.

According to the invention, the implantable device 1 comprises a chamber 2 extending between a puncture zone 3 and an outlet orifice 4 situated vis-à-vis said puncture zone 3.

The puncture zone 3 is designed to be pierced by a needle 5, in particular a hollow needle, for injecting and / or withdrawing a fluid in the chamber 2.

Preferably, said puncture zone 3 comprises a self-sealing membrane 10 or "septum" capable of sealing the device 1, during needle-tapping by the needle 5 and following the withdrawal of said needle 5, the orifice generated by piercing said membrane 10 with the aid of the needle 5 automatically rebouching after extraction of said needle. This self-healing function can advantageously be obtained by producing the self-sealing membrane 10 in an elastomeric material, such as silicone, and preferably by prestressing said membrane 10 in compression.

The outlet orifice 4 is advantageously intended to make the chamber 2 communicate with a duct, flexible or rigid, such as a catheter 6. Thus, the chamber 2 can lead to the environment of the device 1 by means of the outlet port 4.

Of course, the chamber 2 is shaped to accommodate the needle 5. For the purposes of the invention, the term "chamber" refers to a region of space whose volume and dimensions are sufficient to allow the needle 5 issue the puncture zone 3 to traverse said region of space and / or to reach almost all the points of said region of space.

In other words, the chamber 2 is arranged to allow the introduction and the functional progression of the needle 5 therein and not to impede the flow of fluid between the chamber 2 and the reservoir of the device. injection (such as a syringe) associated with said needle 5.

According to an important characteristic of the invention, the device 1 comprises an interposition means 12 protruding into the chamber 2 in order to prevent the needle 5 which enters said chamber 2 through the puncture zone 3 from reaching, and a fortiori to cross, the outlet 4.

In other words, in a chamber 2 according to the invention but "bare", that is to say without the interposition means 12, there would be at least one sufficiently clear passage to draw a trajectory directly connecting a point of the puncture zone 3 to the outlet orifice 4, a path in which a needle 5 which penetrates through the zone of puncture 3 would be likely to reach, or even to cross, the outlet port 4.

Advantageously, this arrangement makes it possible to give the device 1 a simple and compact shape by allowing the puncture zone 3 to be placed close to the outlet orifice 4 while guaranteeing the operating safety of said device despite this proximity.

Indeed, thanks to the interposing means 12 which is interposed between the puncture zone 3 and the outlet orifice 4, it is possible to bring these elements closer together without exposing the orifice 4 or the surroundings of the latter nor, a fortiori, the catheter 6, to the aggressions of the bevel of the needle 5 which would be otherwise likely to cause damage by perforation, laceration or abrasion.

Conversely, this arrangement is also likely, as will be detailed below, to limit the risk of damage to the bevel of the needle 5 in contact with the implantable site 1, and therefore reduces the risk of tearing of the self-sealing membrane 10 under the effect of a damaged bevel, particularly veiled or horny, during the extraction of said needle 5. The operational safety and longevity of the device 1 are thus improved.

Particularly preferably, the interposition means 12 is of course arranged so as not to risk compromising the first function of the device 1 which is to allow a flow of fluid between the needle 5 and the chamber 2 on the one hand between the chamber 2 and the catheter 6 on the other hand.

More particularly, the space left accessible to the needle 5 by the interposition means 12 will preferably be compatible with the introduction of minus all the useful part of the hollow needle 5, that is to say generally of its bevelled part, according to various points of stitching and angles of incidence with respect to the puncture zone 3.

In addition, the residual space of the chamber 2 available at the level of the interposition means 12 for the flow of the injected or punctured fluid will preferably have dimensions, in particular a cross section, at least equal, and preferably greater than those of the outlet 4.

According to the invention, the chamber 2 is delimited by a wall 7, said wall preferably joining the puncture zone 3 to the edge of the outlet orifice 4. Said wall 7 can naturally have various dimensions and geometries without leaving the framework of the invention.

In a particularly preferred manner, the wall 7 is able to withstand perforation by the needle 5, at least in the space of the chamber 2 accessible to said needle 5.

More specifically, the wall 7 may be reinforced so as to withstand the mechanical action of the bevel of the needle 5 at least in all the areas left accessible from the puncture zone 3 by the interposition means 12. Thus, will guarantee the tightness of said wall 7 and therefore the operational safety of the device 1.

According to an alternative embodiment, the wall 7 may comprise an elastomer casing 17, of silicone type, said elastomer casing 17 being able to be reinforced, at least partially and in particular in the zone left accessible to the bevel of the needle 5, using a trellis. Protection against perforation and / or tears may also be provided by a hull. The materials used to prevent perforation of the silicone envelope may be in the form of plates, slats, or threads. They will preferably be chosen from titanium, stainless steel, or else bio-compatible polymers such as, for example, polyether ether ketone (PEEK), poly-sulfone (PSU), polycarbonate ( PC) or poly-ether-amide (PEI).

Furthermore, although it is conceivable that said wall 7 is entirely flexible and / or deformable, the latter will preferably be at least partially rigid or semi-rigid in order to facilitate grasping the device 1 through the patient's skin and the retention of it during the puncture of the puncture area. For this purpose, the wall 7 may comprise, at least over part of its extent, a rigid frame, or comprise a rigid shell.

Advantageously, one can use the same materials and the same elements to stiffen all or part of the structure of the device 1 and give the wall 7 resistance to aggression of the needle (perforation, laceration or abrasion).

In particular, it may be used for this purpose a titanium shell, stainless steel, PEEK, PSU, PC or PEI.

Preferably, the device 1, and more particularly the chamber 2, have a substantially elongate shape along a longitudinal axis (XX ').

In a particularly preferred manner, the puncture zone 3, the chamber 2 and the outlet orifice 4 are substantially aligned in the direction of said longitudinal axis (XX '). Preferably, the ratio between the length of the device 1, measured along the longitudinal axis (XX ') between the puncture zone 3 and the outlet orifice 4, and the overall transverse dimension of said device 1, and more particularly of the puncture zone, is substantially between 1, 5 and 2. Thus, for example, the length of the device 1 may be substantially between 15 mm and 20 mm, and its maximum width of the order of 10 mm.

Advantageously, such an elongated shape makes it possible to confer on the device 1 an atraumatic and discrete character.

According to a preferred embodiment, the device 1 is shaped so that it can be connected in the extension of a catheter 6, as shown in Figures 16 and 17, the puncture zone 3, the chamber 2 , the outlet orifice 4 and the end 6A of the catheter 6 which adjoins said outlet orifice 4 then being preferably substantially aligned along the longitudinal axis (XX '). Preferably, at rest, the septum 10, the chamber 2 and the catheter 6 are substantially coaxial.

Such an arrangement in a row makes it possible to dispense with cumbersome or complex parts forming a duct connecting the chamber 2 to the catheter 6. In particular, it is thus possible to avoid the use of intermediate ducts of unnecessarily large length and / or narrow section that present increased risks of obstruction.

In addition, the combination of an interposition means 12 with an elongate shape ensures both good accessibility to the chamber, preserving a sufficient functional volume, good circulation of fluids through a suitably sized orifice, and a functioning sure of the device without premature damage to the septum, orifice or catheter to which it is connected. The device 1 may have an extension, preferably along the axis (XX '), forming a nozzle 14 for connection to the catheter 6. The bearing surface of the tip 14, optionally supported, may advantageously allow the attachment of the end 6A of the catheter 6, in particular by interlocking, crimping and / or gluing.

According to an alternative embodiment, the tip 14 may be reinforced so as to stiffen the end 6A of the catheter 6 to limit the risk of stenosis or degradation of said catheter 6 by folding. In other words, the device 1 can be extended by a rigid or semi-rigid tip 14 which ensures the continuity of the chamber 2 and which allows the fixation or even the protection of the end 6A of the catheter 6.

It is however remarkable that, according to the invention, the outlet orifice 4 and the end 6A of the catheter, although located opposite the puncture zone 3 through which the needle 5 penetrates, are protected by means of interposition 12, so that it is not necessarily necessary to reinforce intrinsically against aggression (perforation, laceration, abrasion).

Thus, it is conceivable to make the parts of the wall 7 not accessible to the needle 5 and / or the catheter 6 (including its end 6A) from elastomeric materials of simple and inexpensive composition, such as silicone or polyurethane (PU), and thus limit the use of reinforced structures, including composite or metal, only parts of the device exposed to the bevel of the needle 5.

In a particularly preferred manner, only the fraction of the wall 7 which delimits the space of the chamber 2 accessible to the needle 5 will be both stiffened and reinforced against the perforations, preferably with the aid of a single shell element, the remainder of the wall 7 being made of an elastomeric material of silicone or PU type.

The aforementioned elastomeric materials combining flexibility, structural simplicity, ease of implementation and low cost, the device 1 according to the invention can thus present on the one hand a comfort of significant use due to the limitation of the extent of rigid areas, on the other hand a reduced manufacturing cost.

According to a preferred embodiment, the device 1 according to the invention has a geometry of axis revolution (XX ').

More preferably, said device 1 has an external profile which flares out, preferably continuously, towards the puncture zone 3. It is conceivable that said profile is curved.

Advantageously, the combination of a linear arrangement and a geometry of revolution gives the device 1 according to the invention a compact shape, simple and substantially atraumatic. In particular, the continuity of forms offers little grip to a tissue gangue. Moreover, the symmetry of revolution of such a device 1 advantageously makes it possible to overcome the problems related to the angular orientation of the puncture zone 3 with respect to the skin, the use of the implanted device not being affected. by a possible rotation of the latter on itself.

Even more preferably, the device 1 is in the form of a truncated cone 15 whose base 15A substantially corresponds to the puncture zone 3 and the vertex 15B substantially corresponds to the outlet orifice 4, such that this is illustrated in particular in Figures 1, 3, 5a, 5b, 6, 9, 10, 11, 13, 15 or 16. Of course, said cone may have a base of any shape, including circular, semicircular, elliptical, polygonal. However, preference will preferably be given to a base 15A and an apex 15B, respectively a puncture zone 3 and an outlet orifice 4, that are substantially circular and coaxial.

Preferably, the truncated cone 15 has a height, measured between the base 15A and the top 15B ₁ substantially equal to 1.5 to 2 times the diameter of said base 15A. For example, the height of the truncated cone 15 may be substantially between 15 mm and 20 mm, the diameter of said base 15A being substantially equal to 10 mm.

Advantageously, a generally frustoconical shape of the device 1 facilitates its implantation because the angular aperture of the cone contributes to gradually remove the host tissues, for example the subcutaneous tissues, by wedge effect during the introduction of the device .

In addition, a frustoconical shape of the device 1 allows the practitioner to easily identify and locate the puncture area 3 by simply palpating the skin at the implantation area. Indeed, if the septum 10 is located at the base 15A, and preferably occupies substantially all of the latter, its location can occur by simple touch and / or visual location of the edge, preferably rounded, which marks the transition between said base 15A and the flank of the truncated cone 15.

In addition, the progressive spacing provides grip gripping the device 1 by pinching through the skin and thus allows some manipulation by the practitioner, including a dynamic angular orientation relative to the hollow needle to facilitate the introduction of the latter. According to an alternative embodiment not shown, the outer surface of the device 1 may be provided with means facilitating this transcutaneous gripping, such as concave curved fingerprints intended to match the terminal phalanges of the thumb and the index finger. According to an alternative embodiment, the chamber 2 also has a flared shape, said chamber widening, preferably progressively, between the outlet orifice 4 and the puncture zone 3.

According to a preferred embodiment, the chamber 2 has a shape substantially conjugate to the flared external profile of the device 1, in particular a generally frustoconical shape as illustrated in Figures 1, 3, 5a, 5b, 6, 9, 10, 11 , 13, 15 and 16. The thickness of the wall 7 is then likely to be substantially constant.

Particularly advantageously, the use of an implantable site 1 which flares towards the puncture zone 3, a little in the manner of a funnel, optimizes the accessibility to said site by maximizing the useful area for penetration of a needle, that is to say in particular the surface of the self-sealing membrane 10, without having to significantly increase the overall volume, nor the overall size of said implantable site 1.

In particular, the angular opening of the truncated cone 15, that is to say the solid angle formed by the chamber 2 "seen" from the outlet orifice 4, allows different angles of approach of the needle during the quilting. In other words, this arrangement makes the implantable site 1 according to the invention particularly tolerant of the stitching gesture. By combining the taper of the device 1 with the longitudinal arrangement thereof with respect to the catheter 6, the practitioner is advantageously allowed to easily perform a tapping substantially tangential to the skin, which corresponds to the natural act of injection or puncture in a vein.

According to a preferred embodiment of the invention, the interposition means 12 comprises at least one fixed element with respect to the wall 7 and / or with respect to the outlet orifice 4 and / or with respect to the puncture 3. By "fixed element" is meant an element, possibly flexible or deformable, but which has a point of attachment which occupies a substantially constant position with respect to the outlet orifice 4, the wall 7 and / or the membrane self-sealing 10.

According to a preferred embodiment, the interposition means 12 may comprise one or more protuberances 16 protruding from the wall 7 towards the inside of the chamber 2.

In a particularly preferred manner, said protuberances will be integral with the wall 7, and for example made by molding in one piece with said wall 7.

According to an alternative embodiment, the interposition means 12 will comprise at least one plate 18 forming a baffle.

Preferably, said plate 18 will extend along a plane secant to the axis (XX '), and, according to a particularly preferred embodiment, in a plane substantially normal to the axis (XX').

According to an alternative embodiment, the interposition means 12 will comprise a plurality of trays 18, 19 forming baffles.

According to a preferred embodiment, said plates 18, 19 will be baffled stages along the longitudinal axis (XX '), and preferably oriented substantially normally to said axis (XX'), as shown in FIG. 1 .

Preferably, the residual space allowing flow at the baffle of the fluid injected or punctured, and in particular the defined surface between the ends of the trays 18, 19 and the wall 7 or even by spacing between the trays themselves, will be substantially greater than the area of the outlet port 4, so as not to obstruct said flow.

According to another variant embodiment illustrated in FIG. 10, the plates 18, 19 may form a lateral baffle housing the outlet orifice 4. The fluid flow space thus delimited is then slightly offset with respect to the axis (XX ').

As is illustrated in Figures 1, 2 and 10, said plates 18, 19 may advantageously overlap so that their respective projections in a plane normal to the longitudinal axis (XX ') intersect. In other words, the trays 18, 19 will preferably be arranged to form a baffle obscuring the solid angle corresponding to the angular opening of the chamber 2, and / or the puncture zone 3 "seen" since the outlet port 4.

Thus, regardless of the point of penetration of the needle 5 on the membrane 10 and whatever the angle of penetration of said needle 5 into the chamber 2, said needle 5 can not access directly to the outlet orifice 4 and necessarily meet on its way one or more trays 18, 19.

Remarkably, the interposition means 12, and more particularly the trays 18, 19 can thus form either direct stops opposing the progression of the needle 5 within the chamber 2, or deflectors tending to deviate the trajectory of the needle 5 towards a puncture-resistant element, such as the wall 7 or another constituent element of the interposition means 12. Moreover, the interposition means 12 can advantageously comprise flexible elements able to oppose to the progression of the needle a mechanical resistance without damaging the bevel of said needle 5.

In particular, the plates 18, 19 may be made of a reinforced elastomer material able to withstand certain elastic deformations and to withstand perforation without exerting severe stress on the bevel of the needle 5.

It is also conceivable, with reference to FIGS. 3 and 4, that the protuberances 16 are formed by a plurality of lugs attached to the wall 7 at their base.

According to an alternative embodiment, it is conceivable that the interposition means 12 comprise a damping element 20 forming an elastic abutment against the bevel of the needle 5, said damping element 20 being able to deform to progressively block the progression of said needle 5.

More particularly, such a damping element 20 may be in the form of a shield or a screen net between the chamber 2 and the outlet port 4. Preferably, said screen may be supported by one or more feet flexible bearing on the periphery of the outlet port 4 and thus form a kind of stop-mushroom able to crash under the action of compression of the bevel of the needle 5, as is illustrated in Figures 5a and 5b.

Such a solution would in particular make it possible to oppose a progressive resistance to the introduction of the needle 5 into the chamber 2, in order to provide the practitioner with a tactile sensation of stop without risking damage to the bevel.

According to another variant embodiment, the interposition means 12 may comprise a perforation-resistant partition 21, permeable to the injected or punctured fluids and preferably perforated for this purpose, which divides the chamber 2 into at least a first cavity 22 and a second cavity 23, said first cavity 22 remaining accessible to the needle 5 while the outlet orifice 4 is in the second cavity 23.

Thus, it is possible to provide the chamber 2 with a kind of double bottom allowing the flow of fluid between the cavities 22, 23 but preventing the needle 5 from reaching the outlet port 4.

Preferably, as illustrated in FIGS. 6, 7, 8 and 9, the interposition means may be formed by the succession of two perforated partitions 21A, 21B delimiting an intermediate cavity 24 between the first and the second cavity 22, 23.

Lights 25A, 25B, for example oblong, may be provided in said partitions to allow the flow of fluids. Said lumens may optionally be larger than the diameter of the needle 5. They will then preferably have conjugate shapes and / or a cross or offset arrangement to ensure that the needle 5, even if it is likely to pass through the first 21A partition and penetrate into the intermediate cavity 24, can not pass through the two walls successively and therefore can not reach the second cavity 23.

According to an alternative embodiment illustrated in FIG. 9, the intermediate cavity 24 forms a seat and encloses a ball 26 confined with play. in relation to the light 25A, said ball 26, possibly flexible, being able to deflect or block the bevel of the needle 5 in the event that the latter passes through said slot 25A.

Furthermore, as shown in particular in FIGS. 6 and 9, the truncated cone 15 may advantageously be formed by interlocking two paired frustoconical sections 27, 28. Advantageously, each of said sections 27, 28 may preferably bear of material with its wall, one of the perforated partitions 21 A, 21 B.

According to an alternative embodiment illustrated in Figures 11, 13, 15 and 17, the interposing means 12 comprises a curved passage 30 whose curvature is sufficiently pronounced to prevent the needle 5 to pass through.

According to an alternative embodiment illustrated in Figures 11 and 12, the communication between the first and the second cavity 22, 23 is provided by one or more grooves forming a plurality of curved passages 30, said grooves being formed in whole or in part in the wall 7 at the periphery of the partition 21.

More specifically, according to the invention, the curved passage 30 is arranged to form a kind of meander permeable to fluids but impassable by the needle 5, the latter, by nature relatively rigid, can not deform sufficiently to marry on the other hand. such a curved relief so that the bevel necessarily remains prisoner of said passage 30, and this, whatever the angle of incidence and the point of penetration of said needle 5 at the puncture zone 3.

In a particularly preferred manner, said curved passage 30, and more generally the interposition means 12, will nevertheless be shaped to allow the passage of a cleaning device 31 substantially flexible, or even semi-rigid, penetrating the chamber 2 by the puncture zone 3 and intended to pass through the outlet orifice 4 to be introduced into the catheter 6.

By "substantially flexible", it is indicated that cleaning utensil 31 is sufficiently flexible to tolerate a large deformation and in particular multidirectional, preferably elastic, for example by buckling under a thrust force F exerted by the practitioner.

In other words, although the structural rigidity of said cleaning device 31 is sufficient to allow the progression thereof in the chamber 2 and through the catheter 6 under the thrust force F, said rigidity is lower. to that of the needle 5 and compatible with the crossing of the obstacle that is the means of interposition 12.

The cleaning device 31 according to the invention may advantageously consist of a venous introduction mandrel or a wire.

Of course, despite its curved geometry, the curved passage 30 will retain a sufficient section not to form a pronounced throttling likely to cause significant losses in the flow of fluids injected and punctured, or to expose the device 1 at an increased risk of obstruction.

In addition, the interposition means 12 will preferably be free of wells or other cul-de-sacs may prematurely block the progress of the cleaning device 31 by holding captive the distal end thereof.

In particular, the curved passage 30 will preferably comprise at least one guiding ramp 32, of relatively gentle curvature, capable of gradually orienting by deflection the cleaning device 31 towards the outlet orifice 4. For example, in an alternative embodiment based on that shown in FIG. 11, but in which the partition 21 has a convex face towards the puncture zone 3, the guide ramp 32 could advantageously be formed by the combination of said surface curved, which would tend to ricochet the cleaning utensil 31 to the grooves 30, and the bottom of the curved grooves 30 which would then tend to fold the cleaning utensil 31 to the axis (XX ').

According to a preferred embodiment illustrated in Figure 15, the interposing means 12 comprises, for the aforementioned purposes, a helical element 33 defining a curved passage 30 spiral.

Preferably, the axis of said helical element 33 is substantially coincident with the longitudinal axis (XX '), the entrance of the curved passage 30 being oriented towards the puncture zone 3 and the outlet of said passage 30 lying opposite the outlet port 4.

The helicoidal element 33 preferably has at least one complete helical pitch so as to conceal the outlet orifice 4 with respect to the puncture zone 3. The helix angle (pitch angle) will advantageously be chosen from so that the wound surface forming the guide ramp 32 facilitates the progressive bending of the cleaning device 31, when crossing the passage 30, under the driving force F applied by the practitioner.

Thus, particularly advantageously, it is possible to clean the catheter 6, and in particular to open it in the event of an obstruction, by introducing through the puncture zone 3 the cleaning device 31 (using a cannula or a hollow needle 5, for example), by sliding the latter by threading through the curved passage 30, then the outlet orifice 4, then the catheter 6, to the congested zone 35. It is possible to envisage to realise and a mechanical cleaning of the catheter 6 in particular by abrasion, a little like the manner in which a chimney flue is cleaned.

Naturally, the present invention is not limited to a curved passage whose curvature varies continuously. In particular, said passage 30 may comprise, for example, a succession of straight sections, juxtaposed at different angles of orientation so as to form a broken line extending in two or three dimensions, the curvature, in the sense of the invention, thus being discretely obtained by the different changes of direction.

According to the invention, it is conceivable that the device 1 is made by assembling only two parts, a septum 10 being attached, for example glued, to a casing 17, or a shell, frustoconical non-pierceable molded a single holding with the interposition means 12.

According to another alternative embodiment, the device 1 according to the invention is made by modular assembly of four parts, namely: a septum 10, a first frustoconical section 27 forming a rigid shell non-pierceable, for example titanium, an envelope 17 of elastomer covering said first frustoconical section 27 and forming the second frustoconical section 28, and a piece forming the interposition means 12, for example a permeable washer forming a partition 21 or a helical element 33 reported.

The interposition means 12 can then advantageously be crimped into the rigid shell or sandwiched between the two frustoconical sections 27, 28.

According to another variant embodiment illustrated in FIG. 17, the device 1 according to the invention comprises the following three parts: a septum 10, a frustoconical portion 27 rigid and non-pierceable substantially smooth, and an interposition ring 34 resistant to perforation. Said ring 34 constitutes an extension of the chamber 2, preferably cylindrical, with which the interposition means 12 is integral.

Advantageously, said interposition ring 34 is thus interposed between the small base of the frustoconical section 27 and the catheter 6, an end of said ring 34 delimiting the outlet orifice 4 forming the tip 14 on which said catheter can be attached. 6.

Such an arrangement makes it possible to produce a monobloc separation interface, possibly flexible, between the part of the chamber 2 accessible to the needle 5 and the catheter 6, which simplifies both the manufacture of "spare parts" and the assembly of the device. 1, respectively of the implantable system 40 described below, as a whole.

Indeed, as is illustrated in Figures 16 and 17, the device 1 according to the invention is preferably intended to be connected in the extension of a catheter 6.

It is thus possible to constitute an implantable system 40 comprising an implantable device 1 of the "site" type as described above and also comprising a catheter 6 connected to said device 1 so that the chamber 2 communicates with said catheter 6, and more precisely with the internal duct of the tubular forming said catheter 6, through the outlet orifice 4.

The device 1 can therefore advantageously form the tip of an implantable catheter. It is conceivable that the device 1 and the catheter 6 are assembled in a reversible manner so that the system according to the invention can be dismounted.

According to a particularly preferred embodiment of the system 40 according to the invention, the device 1 and the catheter 6 are secured by a recess connection arranged such that they form a one-piece assembly.

It is therefore possible to form said unitary assembly either during manufacture in the factory, or only during use in the operating room, by irreversibly assembling a device 1 and a catheter 6 provided separately.

The catheter 6 may in particular be threaded onto the tip 14 and bonded thereto by gluing.

In addition, it is conceivable that the device 1 constitutes a tip intimately secured to the catheter 6, or that at least a portion of the device 1 is integral with the tubing of said catheter 6 and forms a bulge of the end 6A. It is thus conceivable to achieve a substantially continuous junction having no protrusion or abrupt shape likely to provide a socket tissue gangue or to damage the surrounding tissue.

Thus, particularly advantageously, the device 1 according to the invention is particularly compact and has an atraumatic shape that facilitates implantation and improves both physical and aesthetic comfort for the patient. Advantageously, the device 1 according to the invention has a particularly simple structure, requiring few parts and assembly operations, which can significantly reduce its manufacturing cost.

In addition, the implantable site according to the invention is particularly ergonomic and allows the practitioner intuitive pricking since it is practiced substantially substantially identical to the pricking of a natural vein.

Advantageously, the device 1 according to the invention reconciles a particularly large and easily identifiable stitching surface area with a relatively small overall size.

Particularly advantageously, the device 1 according to the invention allows a safe implementation of the stitching to the extent that it allows on the one hand to identify and easily identify the puncture area and on the other hand to respect the physical integrity of both the implantable site and the catheter and needle.

Finally, the possibility of regularly maintaining the system 40 according to the invention, and more precisely the catheter 6, with the aid of a cleaning device advantageously makes it possible to optimize the duration of use of said system 40 after its implantation. .

POSSIBILITY OF INDUSTRIAL APPLICATION

The invention finds its industrial application in the design and manufacture of implantable sites for injecting and / or sampling fluids.

Claims

- Implantable device (1) for injecting and / or sampling fluid in a human or animal body, said device comprising a chamber (2) extending between a puncture zone (3), designed to be pierced by a needle (5) for injecting and / or withdrawing a fluid, and an outlet (4) facing said puncture zone (3) and for communicating said chamber ( 2) with a conduit such as a catheter (6), said chamber (2) being shaped to accommodate the needle (5), said device (1) being characterized in that it has a substantially elongated shape along an axis longitudinal axis (XX '), in that the puncture zone (3), the chamber (2), and the outlet orifice (4) are substantially aligned in the direction of said longitudinal axis (XX'), and in that it comprises an interposition means (12) projecting into the chamber (2) to prevent the needle (5) which enters said chamber e (2) through the puncture zone (3) to reach the outlet (4).

- Device according to claim 1 characterized in that it is shaped so as to be connected in the extension of a catheter (6), the puncture area (3), the chamber (2), the outlet port (4) and the end (6A) of the catheter adjacent said outlet (4) being then substantially aligned along the longitudinal axis (XX ').

- Device according to one of claims 1 or 2 characterized in that it is in the form of a truncated cone (15), the base (15A) substantially corresponds to the puncture zone (3) and the vertex (15B) substantially corresponds to the outlet orifice (4). 4 - Device according to one of the preceding claims characterized in that the chamber (2) has a flared shape, preferably frustoconical, said chamber (2) widening between the outlet (4) and the puncture area (3).

5 - Device according to one of claims 1 to 4 characterized in that the chamber (2) is delimited by a wall (7) and in that said wall (7) is able to resist perforation by the needle ( 5) at least in the space of the chamber (2) accessible to said needle (5).

6 - Device according to claim 5 characterized in that only the fraction of the wall (7) which defines the space of the chamber (2) accessible to the needle (5) is both stiffened and reinforced against perforations, preferably with the aid of a single shell element, the remainder of the wall (7) being made of an elastomeric material of silicone or PU type.

7 - Device according to claim 5 or 6 characterized in that the interposition means (12) comprises at least one fixed element relative to the wall (7) and / or relative to the outlet orifice (4) and / or with respect to the puncture zone (3).

8 - Device according to one of claims 5 to 7 characterized in that the interposition means (12) comprises one or more protrusions (16) projecting from the wall (7) towards the inside of the chamber (2) .

9 - Device according to claim 8 characterized in that said protuberances (16) are integral with the wall (7).

10 - Device according to one of the preceding claims characterized in that the interposition means (12) comprises a plate (18) forming a baffle. - Device according to claim 10 characterized in that the interposing means (12) comprises a plurality of trays (18, 19) baffled stages along the longitudinal axis (XX ').

- Device according to claim 11 characterized in that said plates (18, 19) overlap so that their respective projections in a plane normal to the longitudinal axis (XX ') intersect.

- Device according to one of the preceding claims characterized in that the interposing means (12) comprises a partition (21), resistant to perforation and permeable to injected or punctured fluids, which divides the chamber (2) into at least a first cavity (22) and a second cavity (23), said first cavity (22) remaining accessible to the needle (5) while the outlet (4) is in the second cavity (23).

- Device according to one of the preceding claims characterized in that the interposing means (12) comprises flexible elements adapted to oppose the progression of the needle (5) a mechanical strength without damaging the bevel of said needle.

- Device according to claim 14 characterized in that the interposing means (12) comprises a damping element (20) forming an elastic stop against the bevel of the needle (5), said damping element (20) being adapted to to deform to gradually block the progression of said needle (5).

- Device according to one of the preceding claims characterized in that it has a geometry of axis revolution (XX '). 17 - Device according to one of claims 5 to 9 characterized in that the wall (7) comprises a casing (17) of elastomer, silicone type.

18 - Device according to one of the preceding claims characterized in that the interposing means (12) comprises a curved passage (30) whose curvature is sufficiently pronounced to prevent the needle (5) to pass through.

19 - Device according to one of the preceding claims characterized in that the interposition means (12) comprises a helical element (33) defining a curved passage (30) spiral.

20 - Device according to one of the preceding claims characterized in that the interposition means (12) is shaped to allow the passage of a substantially flexible cleaning device (31) penetrating the chamber (2) by the zone of puncture (3) and for passing through the outlet (4) to be introduced into the catheter (6).

21 - Device according to one of the preceding claims characterized in that the puncture zone (3) comprises a self-sealing membrane (10).

22-implantable system (40) comprising an implantable device (1) according to one of claims 1 to 21, said system (40) further comprising a catheter (6) connected to said device (1) so that the chamber (2) communicates with said catheter (6) through the outlet (4).

23 -System (30) according to claim 22 characterized in that said implantable device (1) and the catheter (6) are secured by a recess connection arranged such that they form a one-piece assembly.