US20080039772A1

US20080039772A1 - Implantabel Medical Site

Info

Publication number: US20080039772A1
Application number: US11/573,930
Authority: US
Inventors: Jean-Francois Chantriaux; Marie-Pierre Diedonnee
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: 2008-02-14
Also published as: BRPI0419150A; CA2577614A1; MX2007001991A; US8088112B2; EP1804898A1; WO2006027425A1; EP1796780A1; CN101014382A; WO2006021695A1; US20080119798A1; AU2004323123A1

Abstract

An implantable device (1) for injecting and/or drawing fluid having a housing (2) with a chamber (2A) formed therein. The housing (2) includes a proximal wall (4) and a distal wall (5) between which a side wall extends, and an aspiration zone (7) designed to be perforated by a hollow needle for injecting and/or drawing fluid into the chamber (2A). The aspiration zone (7) extends simultaneously on the proximal wall (4), the side wall and the distal wall (5). The device (1) has a shield (13) made of a material not perforable by a hollow needle inside the chamber (2A) to prevent the housing (2) from being perforated by a hollow needle.

Description

TECHNICAL FIELD

The present invention relates to the general technical field of devices for inserting under the skin of a human or animal patient in order to be capable of being pierced subsequently by a hollow needle through the skin of the patient for the purpose of introducing and/or extracting substances into or from the body of the patient, while limiting cutaneous trauma repeated at the same location. Such devices are generally referred to as implantable sites or else as access ports.
The present invention relates more particularly to an implantable device for injecting and/or extracting fluid either into or from an organ or a vessel of the body of a human or animal patient, or else into or from an inflatable and/or deflatable compartment of a surgical implant, said device comprising a housing within which there is formed a chamber for connection to a catheter, said catheter itself being for connection either to said organ or vessel or else to said compartment, the housing having a proximal wall and a distal wall between which there extends a side wall, said housing having a puncture zone designed to be pierced by a hollow needle in order to inject and/or extract fluid into or from the chamber.

PRIOR ART

Known implantable sites are generally in the form of a housing including an end wall from which there extend side walls whose free ends define a proximal opening.
The end wall and the side walls are made of solid and rigid material, such as titanium, to ensure that they cannot be pierced by a needle. The proximal opening is closed by a substantially plane membrane of self-sealing material, thus forming a “septum”.
Although such devices generally give satisfaction, they nevertheless present drawbacks that are not negligible.
Thus, although those known devices are relatively bulky and thus potentially uncomfortable for the patient, they provide an injection area that is small, thus exposing the surrounding tissue to risks of lesions by perforation, since the probability of the practitioner piercing away from the “septum” is far from being negligible.
Furthermore, those known devices are liable to turn over under the skin, under the effect of movements of the patient. In extreme circumstances, the site can thus be turned through 180°, thereby totally masking the “septum”. The device as turned over in this way then becomes unusable, which requires new surgery to implant a new device.
In order to remedy that problem of the site turning over, proposals have been made to bind the site to surrounding biological tissues. In order to achieve such fastening, known devices are provided with holes that enable them to be sutured to neighboring biological tissues.
Nevertheless, such a solution is not very satisfactory, since it requires a relatively large surgical approach path, and surgery that is longer and difficult, while increasing patient discomfort and the risk of infection.

SUMMARY OF THE INVENTION

Consequently, the objects given to the invention seek to propose a novel implantable fluid injection and/or extraction device capable of remedying the various drawbacks mentioned above and facilitating the operations of implanting the device, and also of injecting and/or extracting fluid, regardless of the orientation of the device under the skin of the patient, and without risk of injuring the patient with the needle.
Another object of the invention is to propose a novel implantable fluid injection and/or extraction device that enables the practitioner to pierce the skin using a technique that is substantially similar to that implemented when piercing a natural vein.
Another object of the invention is to propose a novel implantable fluid injection and/or extraction device that reduces the risks and drawbacks associated with body movements of the patient.
Another object of the invention is to propose a novel implantable fluid injection and/or extraction device that does not need to be sutured to the body of the patient.
Another object of the invention is to propose a novel implantable fluid injection and/or extraction device that is of particularly simple and compact design.
Another object of the invention is to propose a novel implantable fluid injection and/or extraction device that is particularly lightweight.
Another object of the invention is to propose a novel implantable fluid injection and/or extraction device that is particularly reliable.
The objects given to the invention are achieved with the help of an implantable device for injecting and/or extracting fluid either into or from an organ or vessel of the body of a human or animal patient, or into or from an inflatable and/or deflatable compartment of a surgical implant, said device comprising a housing within which there is formed a chamber designed to be connected to a catheter, said catheter itself being designed to be connected either to said organ or vessel or to said compartment, the housing comprising a proximal wall and a distal wall with a side wall extending between them, said housing including a puncture zone designed to be capable of being pierced by a hollow needle in order to inject and/or extract fluid into or from the chamber, the device being characterized in that said puncture zone is shaped in such a manner as to extend simultaneously at least over the proximal wall, the side wall, and the distal wall, said device including a screen made of a material that is not pierceable by the hollow needle and disposed within the chamber in order to prevent the housing being pierced right through on being pierced by the hollow needle.

BRIEF SUMMARY OF THE DRAWINGS

Other objects and advantages of the invention appear better on reading the following description and with the help of the accompanying drawings, given in purely illustrative and non-limiting manner, and in which:
FIG. 1 is a diagrammatic perspective view of a first embodiment of a device in accordance with the invention;
FIG. 2 is a diagrammatic perspective view of a second embodiment of a device in accordance with the invention;
FIG. 3 is a diagrammatic perspective view of a third embodiment of a device in accordance with the invention;
FIG. 4 is a diagrammatic perspective view showing a fourth embodiment of a device in accordance with the invention;
FIG. 5 is a diagrammatic perspective view showing a fifth embodiment of a device in accordance with the invention;
FIG. 6 is a diagrammatic longitudinal section view showing a sixth embodiment of a device in accordance with the invention;
FIG. 7 is a diagrammatic longitudinal section view showing a seventh embodiment of a device in accordance with the invention;
FIG. 8 is a diagrammatic cross-section showing a device in accordance with one or other of the sixth and seventh embodiments shown respectively in FIGS. 6 and 7;
FIG. 9 is a diagrammatic cross-section view showing an eighth embodiment of a device in accordance with the invention;
FIG. 10 is a diagrammatic perspective view showing the internal structure of the device shown in FIG. 2;
FIG. 11 is a diagrammatic side view showing a ninth embodiment of a device in accordance with the invention, forming an artificial vein;
FIG. 12 is a diagrammatic cross-section view of the device shown in FIG. 11;
FIG. 13 is a diagrammatic cross-section view showing a tenth embodiment of a device in accordance with the invention;
FIG. 14 is a diagrammatic cross-section view showing an eleventh embodiment of a device in accordance with the invention;
FIG. 15 is a diagrammatic cross-section view showing a twelfth embodiment of a device in accordance with the invention;
FIG. 16 is a diagrammatic cross-section view showing a thirteenth embodiment of a device in accordance with the invention;
FIG. 17 is a diagrammatic cross-section view showing a fourteenth embodiment of a device in accordance with the invention;
FIG. 18 is a diagrammatic cross-section view showing a fifteenth embodiment of a device in accordance with the invention;
FIG. 19 is a diagrammatic cross-section view showing a sixteenth embodiment of a device in accordance with the invention;
FIG. 20 is a diagrammatic cross-section view showing a seventeenth embodiment of a device in accordance with the invention;
FIG. 21 is a diagrammatic cross-section view showing an eighteenth embodiment of a device in accordance with the invention;
FIG. 22 is a diagrammatic view showing the principle on which the screen fitted to the device shown in FIG. 21 operates;
FIG. 23 is a diagrammatic view, partially in longitudinal section, showing a nineteenth embodiment of a device in accordance with the invention;
FIG. 24 is a diagrammatic view partially in longitudinal section showing a twenty-first embodiment of a device in accordance with the invention, in which the puncture zone is being pierced by a hollow needle;
FIG. 25 is a diagrammatic cross-section view showing the device of FIG. 24, but with the hollow needle not being shown; and
FIG. 26 is a diagrammatic view partially in longitudinal section showing a twenty-first embodiment of a device in accordance with the invention.

BEST MANNER OF PERFORMING THE INVENTION

The invention relates to an implantable fluid injection and/or extraction device 1. Such a device, which can also be referred to as a “implantable site”, is for being implanted, e.g. surgically, in the body of a patient, and in particular under the skin of said patient, in order to constitute an access port for injecting and/or extracting fluids into or from the body of said patient, which may be human or animal.
The implantable device 1 in accordance with the invention can be implemented and adapted to a variety of uses.
Firstly, the implantable device 1 in accordance with the invention may be designed for injecting and/or extracting fluid into or from an organ or a vessel of the body of a patient, and in particular in the venous and/or arterial system of said patient. In this application, which is known in itself, the device 1 in accordance with the invention enables medication to be injected into a vein or an artery.
The device 1 in accordance with the invention may also be adapted to feed implanted reservoirs, of the insulin pump or antalgic type.
In another particular embodiment, unknown in the prior art, the device 1 in accordance with the invention is adapted to form an artificial vein (or artery), that a practitioner, a doctor, or a nurse, can pierce like a natural vein for injecting medication or taking blood.
The implantable device 1 in accordance with the invention may also be adapted to injecting and/or extracting fluid into or from an implantable and/or deflatable compartment of a surgical implant, and in particular a gastroplasty ring for treating obesity.
Such a gastric ring is itself known, and is generally formed by a flexible strip designed to be closed in a loop around the stomach substantially towards and at its two ends, using a closure system in order to reduce the diameter of the aperture of the stoma. Said strip may include an annular compression chamber of adjustable volume connected by a catheter to an implantable device 1 in accordance with the invention, thus enabling the pressure inside the chamber to be adjusted, so as to adjust the diametral expansion thereof.
The device of the present invention may nevertheless be used for adjusting other surgical implants, e.g. such as balloons or artificial sphincters.
Below, reference is made more particularly to a hypodermic device, i.e. a device designed to be positioned immediately under the skin of the patient. The device in accordance with the invention could nevertheless also be implanted at other locations within the body of the patient, and in particular at greater depth.
In accordance with the invention, the device 1 comprises a housing 2 within which there is provided a chamber 2A that is substantially hermetically closed and leaktight. The chamber 2A is defined by a chamber wall 2B, thus defining an internal volume for receiving a fluid to be injected and/or extracted into or from the body of the patient. Said chamber 2A is designed to be connected to a catheter 3, said catheter 3 itself being designed to be connected either to an organ or vessel 10 into which it is desired to inject fluid or from which it is desired to take fluid (cf. FIG. 11), or else to an inflatable/deflatable compartment of a surgical implant (not shown).
Advantageously, the housing 2 is provided with guide means for co-operating with a guide wire to facilitate placing the device 1 under the skin of the patient. The guide means (not shown) preferably co-operate slidably with the guide wire, the guide wire being threaded through said guide means. In more preferable manner, the guide means are formed by a through tunnel formed within the housing 2, extending along the entire length thereof, e.g. coaxially with the axis of symmetry of the housing 2. In particular, the housing 2 may include a central tunnel for receiving the guide wire and around which there is provided the chamber 2A, said chamber then being annular in shape.
In accordance with the invention, the housing 2 has a proximal wall 4 and an opposite distal wall 5, between which there extends a side wall 6. The term “proximal”, conventionally designates the wall that is to be situated immediately under skin of the patient, once the device has been implanted subcutaneously.
In conventional manner, the housing 2 includes a puncture zone 7 designed to be capable of being pierced by a hollow needle 14, in order to inject and/or extract fluid into or from the chamber 2A.
Advantageously, the puncture zone 7 comprises a self-sealing membrane, e.g. made of an elastomer material of the silicone type. Such a membrane presents “self-healing” properties. By means of these properties, the orifice generated by the membrane being pierced by the needle 14 closes automatically after the needle 14 has been extracted, thus enabling the chamber 2A to be maintained substantially leaktight.
In accordance with an important characteristic of the invention, the puncture zone 7 is shaped in such a manner as to extend simultaneously over the proximal wall 4 and the distal wall 6, i.e. so that the puncture zone 7 extends substantially around at least part of the outlines of said proximal and side walls 4 and 6.
In other words, unlike prior art devices, in which the puncture zone extends over a portion of the proximal wall only, thus requiring the device 1 to be firmly sutured to the surrounding tissues, the invention proposes a radically opposite concept, consisting in extending the puncture zone 7 to the side wall 6 so as to make it pointless, or at least non-essential, to secure the device 1 by means of a suture.
In the event of the device 1 in accordance with the invention turning over, i.e. changing its orientation, e.g. under the effect of movements of the patient, the probability of the puncture zone 7 being no longer accessible is reduced, given that the puncture zone 7 extends not only over the proximal wall 4 as in the prior art, but also over the side wall 6.
Advantageously, the puncture zone 7 is shaped so as to extend simultaneously at least over the proximal wall 4, the side wall 6, and the distal wall 5, so as to constitute a piercing zone of size and shape that are sufficient to ensure that the housing 2 can be “jabbed” regardless of its angular orientation under the skin of the patient.
In a first embodiment, shown in FIG. 1, the proximal, distal, and side walls 4, 5, and 6 combine together to form a surface that is substantially polyhedral.
More particularly, in the example of FIG. 1, proximal, distal, and side walls 4, 5, and 6 form a rectangular parallelepiped. Under such circumstances, the side wall 6 is formed firstly by two parallel longitudinal panels 6A, 6B and secondly by two parallel transverse panels 6C, 6D, said transverse panels 6C, 6D extending in a direction substantially perpendicular to the direction in which the longitudinal panels 6A, 6B extend.
Advantageously, the catheter 3 is designed to be connected to the chamber 2A through one of the transverse panels 6C, 6D via a duct 3A connecting the chamber 2A to the outside of the device 1 and extending longitudinally substantially in the same direction as the longitudinal panels 6A, 6B. Under such circumstances, the catheter 3 is distinct from the duct 3A and the housing 2.
Naturally, and without thereby going beyond the ambit of the invention, it is possible to envisage the catheter 3 being made integrally with the duct 3A so that together they form a single part. Under such circumstances, the housing 2 and the catheter 3 form a unit, the catheter 3 being secured to the chamber 2A by construction and not being designed to be separated from the housing 2.
Advantageously, the puncture zone 7 extends over the major portion, or even substantially the totality of the proximal and distal walls 4 and 5 and the longitudinal panels 6A, 6B. The transverse panels 6C, 6D could naturally also constitute part of the puncture zone 7, although that is not really necessary, given there is little risk of the device 1 turning about the transverse direction. Thus, all of the faces of the housing 2 shown in FIG. 1 can advantageously be used for puncturing, such that accidental turning over of the site 1 (or a mere change of its orientation) does not lead to genuinely troublesome consequences for the practitioner or the patient.
The variants of FIGS. 2 to 8 are described in greater detail below.
In the various embodiments shown in FIGS. 2 to 8, the duct 3A connecting the chamber 2A to the outside of the device 1 and for connection to the catheter 3 extends longitudinally along a first axis X-X′.
In order to establish a reliable mechanical connection between the duct 3A and the catheter 3, the duct 3A may be provided with a coaxial swelling 30A (cf. FIGS. 6 and 7) of diameter slightly greater than the nominal inside diameter of the catheter 3. Conventionally, the catheter 3 presents a certain amount of radial elasticity and is thus engaged by force on the duct 3A and its swelling 30A, which serves to hold the catheter.
It is also possible to clamp the catheter 3 onto the duct 3A by means of a clamping ring.
Advantageously, the catheter 3 is surrounded, in the vicinity of the duct 3A, with stiffener means 20 (cf. FIGS. 1 to 5), e.g. constituted by a helical wire or tube 21 like a spring. The stiffener means 20, which may nevertheless present a certain amount of flexibility in bending, serve to avoid phenomena of the catheter 3 being accidentally closed by the catheter 3 kinking.
In accordance with the embodiments of FIGS. 2 to 8, the proximal, distal, and side walls 4, 5, and 6 are shaped and arranged in such a manner that the housing 2 is substantially symmetrical about a second axis Y-Y′, said second axis Y-Y′ being substantially parallel to the first axis X-X′.
The housing 2 thus presents circular symmetry about a second axis Y-Y′, that extends substantially in the same direction as the duct 3A for connection to the catheter 3. Under such circumstances, because of the axial symmetry of the housing 2, the proximal, distal, and side walls 4, 5, and 6 run substantially into one another and form a single surface of revolution.
Advantageously, the proximal, distal, and side walls 4, 5, and 6 contribute together to forming a surface that is substantially spherical, as shown in FIG. 3. In this configuration, the puncture zone 7 may extend substantially over all of the proximal, distal, and side walls 4, 5, and 6, i.e. over substantially the entire spherical surface. Nevertheless, without thereby going beyond the ambit of the invention, provision could be made for the puncture zone 7 to extend only over a central circular zone of the spherical surface, said circular zone being symmetrical about the second axis Y-Y′, which preferably coincides with the first axis X-X′.
In another embodiment, shown in FIG. 2, the proximal, distal, and side walls 4, 5, and 6 together contribute to forming a surface that is substantially ovoid, extending longitudinally along the axis Y-Y′ in the same direction as the duct 3A.
Such an ovoid housing turns out to be particularly easy to insert under the skin of the patient, and is particularly well tolerated thereby.
As with the spherical housing shown in FIG. 3, the puncture zone 7 of the ovoid housing of FIG. 2 may extend substantially over the entire surfaces of the proximal, distal, and side walls 4, 5, and 6, i.e. over the entire ovoid surface. However it is also possible, and this configuration is preferred, for it to occupy only a central circular zone of the ovoid surface, said circular zone being symmetrical about the second axis Y-Y′.
In the variant shown in FIG. 4, the proximal, distal, and side walls 4, 5, and 6 together contribute to forming a surface that is substantially pear-shaped.
Preferably, the duct 3A for connection to the catheter 3 is connected to the chamber 2A via the tip of the pear-shaped surface.
Advantageously, the puncture zone 7 can extend over substantially the entire area of the proximal, distal, and side walls 4, 5, and 6, or it may occupy merely a portion of the pear-shaped surface, and for example, and as described for the above variants, it may occupy only a central circular zone about the axis of symmetry Y-Y′.
In another embodiment, shown in particular in FIGS. 5 to 8, the proximal, distal, and side walls 4, 5, and 6 together contribute to forming a surface that is substantially cylindrical. The puncture zone may extend over substantially all of said cylindrical surface, or over a portion only of said surface, and in particular a central circular zone thereof.
Advantageously, the housing 2 corresponding to the embodiment shown in FIG. 6 has a front ring 15 and a rear ring 16 positioned facing each other and spaced apart, being coaxial about the first and second axes X-X′ and Y-Y′. Between the rings 15, 16 there is positioned a cylindrical sleeve 17 made of elastomer material and forming the puncture zone 7. The duct 3A is engaged in the front ring 15, so as to be centered relative to the axis Y-Y′.
The front and rear rings 15 and 16 may optionally be interconnected mechanically by spacers (not shown), thus enabling the sleeve 17 to be maintained under longitudinal compression stress. In order to obtain this compression prestress effect, it suffices to dimension the sleeve 17 so that its length is slightly longer than the distance between the front and rear rings 15 and 16. The sleeve 17 is then inserted by force between the two rings, thereby setting up compression in the elastomer material along the axis Y-Y′, which coincides in these examples with the axis X-X′.
It is also possible, as shown in FIG. 7, to envisage that the housing 2 includes only one distinct ring, i.e. the front ring 15, the rear ring itself being made integrally with the sleeve 17. Provision can then advantageously be made for the region of the sleeve 17 that corresponds to the rear ring 16 to be made of an elastomer material that is different from that from which the remainder of the sleeve is made, for example material that presents greater hardness.
Advantageously, and regardless of the embodiment involved, the housing 2 in accordance with the invention may be made up of a frame 12 made of a material that is substantially not pierceable by a needle 14 and that presents a certain amount of rigidity (cf. FIG. 10). The frame 12 is advantageously covered by an envelope (not shown) made of a self-sealing material, said frame 12 having openings so as to form said puncture zone 7 in co-operation with said envelope. More particularly, the frame 12 is designed to give the housing 2 its general shape, specifically an ovoid shape for the example shown in FIG. 10. This frame 12 serves to support an envelope that is in the form of a substantially elastic pouch suitable for being engaged, preferably by force, over the frame 12 and for taking up its general shape, like a sock. Advantageously, the elastic pouch is thus stretched over the frame 12. The envelope may advantageously comprise a membrane of elastomer material, of the biomedical silicone type.
The frame 12 is perforated, at least locally, by a series of orifices of sufficient size to allow the needle 14 to pass through. After initially piercing the envelope, the needle can thus reach the internal volume defined by the frame 12 and corresponding to the chamber 2A.
Advantageously, the frame 12 is constituted by a lattice of rigid material, as shown in FIG. 10. For example, the lattice may be made of titanium wires or of stainless steel wires, or it may be obtained by molding a plastics material.
Above, housings 2 are described that present circular symmetry about the second axis Y-Y′ that is itself parallel to or coincides with the first axis X-X′. Nevertheless, without going beyond the ambit of the invention, it is possible to envisage that the housing 2 is not genuinely circularly symmetrical but is merely formed by a curved or warped surface, e.g. of elliptical section, as shown in FIG. 9.
Advantageously, and as shown in FIGS. 6 to 9, a screen 13 made of material that is not pierceable by the needle 14 is placed within the chamber 2A so as to prevent the housing being pierced right through by the needle 14. In other words, the screen 13 is designed to prevent the tip of the needle 14, once it is located inside the chamber 2A, from continuing its travel by piercing the housing 2 again and thus projecting from the housing 2 into the body of the patient.
The screen 13 acts as an abutment for the needle 14. In particular, the screen 13 should be designed as a function of the shape of the puncture zone 7 so as to ensure that said puncture zone 7 can be pierced effectively and reliably at any point.
In the meaning of the invention, the term “disposed within the chamber” when used in respect of the screen 13 should be understood broadly. The invention relates in particular to implantable devices provided with screens 13 that are embedded in the structure of the housing 2 and in particular in the wall of the chamber 2B, which is advantageously formed by the membrane forming the puncture zone 7.
Advantageously, the screen 13 comprises a bladed wheel shaped and positioned in such a manner that the blades 13A, 13B, 13C, and 13D extend substantially radially about the axis of symmetry Y-Y′ of the housing 2. In particular, and as shown in FIGS. 8 and 9, said blades 13A, 13B, 13C, and 13D extend radially from a central axis, which itself preferably coincides with the axis of symmetry of the housing 2.
Advantageously, the blades are at least four in number and regularly spaced apart angularly. Naturally, it is possible to provide for the number of blades to be greater or smaller, or indeed to provide some other type of screen 13.
The screen 13 is also preferably shaped so as to allow fluid communication and circulation to take place within the chamber 2A.
For example, in FIGS. 8 and 9, where the screen 13 is formed by a wheel having four plane blades 13A, 13B, 13C, and 13D, the four compartments defined within the chamber 2A by said blades 13A, 13B, 13C, and 13D are not sealed relative to one another and are all in fluid communication with one another, even if indirectly. To do this, it is possible for example to ensure that the blades are of a size that ensures they do not fit closely against the walls of the housing 2.
The screen 13 may slope freely within the chamber 2A, or possibly it might be held in position using a specific fastener system. Said fastener system could, for example, comprise centering shafts 13E, 13F (cf. FIG. 6) co-operating with complementary recesses formed within the housing, so as to hold the bladed wheel in position, while possibly allowing it to turn about the axis Y-Y′.
Advantageously, the bladed wheels forming the screen 13 is mounted to rotate within the chamber 2A. Thus, and as shown in FIG. 13, the bladed wheel preferably comprises a rotary shaft 13G extending along the axis of symmetry of the housing 2 and of the puncture zone 7, the shaft 13G having two curved blades 13H, 13I extending therefrom that are diametrically opposite about the shaft 13G. Naturally, the number of curved blades 13H, 13I used could be greater than two without thereby going beyond the ambit of the invention.
In another embodiment, three subvariants of which are shown in FIGS. 14 to 16, the screen 13 advantageously comprises at least one stop panel 18A-18G for the hollow needle 14, mounted to bear slidably against the wall of the chamber 2B so that said panel 18A-18G can be moved within the chamber 2A under the effect of thrust exerted by the hollow needle 14 towards the inside of the chamber 2A, during a puncture operation.
In other words, the technical principle underlying the embodiments of FIGS. 14 to 16 lies in implementing “overall” displacement of the screen 13 under the effect of the force exerted by the needle 14 when it comes into abutment against the screen 13, the displacement thereof being guided by the panels 18A-18G bearing slidably against the wall 2B of the chamber 2A.
In the variant of FIG. 14, the screen 13 comprises two stop panels 18A-18B, preferably presenting similar curved shapes, said panels being disposed symmetrically in a substantially Y-shaped or V-shaped configuration, each of the three ends of said Y-shape or V-shape being connected to a corresponding skid 19A-19C, said skid bearing slidably against the wall 2B of the chamber 2A. The panels 18A, 18B and their associated skids 19A-19C thus form a unit that is guided in rotation within the chamber 2A.
The displacement of the screen 13 in the variant of FIG. 14 is thus controlled and can take place along one or more predetermined degrees of freedom, only.
In this particular embodiment, the invention is naturally not restricted to a screen being V-shaped or Y-shaped, and, for example, the panels may be S-shaped (cf. panel 18C in FIG. 15) or W-shaped (cf. panel 18D, 18E, 18F, 18G, in FIG. 16).
In the variant of FIG. 15, the screen 13 is preferably formed by a single panel 18C having two curves to form an S-shape, each of the ends of the S-shape being provided with a corresponding skid 19D, 19E, that bears against the wall 2B.
In the variant of FIG. 16, the screen 13 is formed by four plane panels 18D, 18E, 18F, 18G interconnected in a concertina configuration to form a W-shape, with each of the vertices of the W-shape being provided with a corresponding skid 19F-19J designed to slide against and along the wall 2B of the chamber 2A.
Naturally, the variant of FIGS. 14 to 16 is not limited to a particular number or shape for the panels, nor is it limited to a particular number or shape for the skids, which skids may be rounded in shape as in the variant of FIGS. 15 and 16, or more spatula-shaped, as in the variant of FIG. 14.
In the variants of FIGS. 14 to 16, the panels 18A-18G are preferably substantially rigid, and are designed so that the needle 14 naturally cannot pierce them.
In another embodiment of the invention, two subvariants of which are shown in FIGS. 17 and 18, the screen 13 comprises at least one stop panel 18H-180 for the hollow needle 14, preferably disposed facing and in the vicinity of the chamber wall 2B, said at least one panel 18H-180 being deformable under the effect of thrust exerted by the hollow needle 14.
In other words, in this embodiment shown in FIGS. 17 and 18, the panels constituting the screen 13 are not displaced under the effect of the thrust exerted by the hollow needle (as applies in the variant described above), but deforms locally under the effect of this thrust.
In particular, as shown in FIG. 17, the screen 13 may comprise four panels 18H-18K secured to one another so to cover the entire surface of the wall 2B that might be pierced by the needle 14. Specifically, each panel presents in cross-section a profile that is substantially in the form of one-fourth of a circle, such that together the four panels present an outline that is substantially circular, corresponding to the circular shape of the section of the chamber 2A.
As shown in FIG. 17, under the effect of the thrust exerted by the needle 14, the panel 18H deflects towards the inside of the chamber 2A so as to reach a deformed configuration 18B (represented by dashed lines in FIG. 17).
Preferably, each panel 18H-18K is deformable in bending. Naturally, it is entirely possible, without going beyond the ambit of the invention, to envisage that the panels 18H-180 are deformed in some other mode, for example in compression or in traction.
It is also possible to envisage that each panel 18H-18O comprises a plurality of substantially rigid unitary elements interconnected by flexible links to form the panel. Under such circumstances, the panel is not deformed because of the intrinsic ability of the material forming the panel to deform, but by displacing its rigid unitary elements.
Advantageously, and as shown in FIG. 18, the panels 18L-180 may present an initial shape that is curved towards the inside of the chamber 2A.
As shown in FIG. 17, it is also entirely possible to envisage the screen 13 being placed freely within the chamber 2A, or on the contrary the screen 13 being secured locally to the wall 2B of said chamber 2A, as shown in FIG. 18.
When secured locally, each panel is secured to the wall 2B of the chamber 2A via two associated lines of connection 20A-20D, each connection line 20A-20D being common to two panels, when four panels are used as shown in FIG. 18.
Advantageously, and as shown in FIG. 20, the screen 13 comprises a flexible membrane 21 of shape substantially matching the shape of the wall of the chamber 2B, said membrane 21 being placed freely within the chamber 2A and being deformable under the effect of thrust exerted by the hollow needle 14.
In the example shown in FIG. 20, where the puncture zone 7 is substantially ovoid in shape, as shown in FIG. 2, the membrane 21 also presents a matching substantially ovoid shape, that fits closely substantially to the shape of the wall 2B.
Advantageously, said membrane 21 can define a closed volume, in which case it forms a flexible pouch. The membrane 21 is made of a material that is supple and flexible, but that is strong enough to ensure that it cannot be pierced by the needle 14.
Advantageously, the membrane 21 presents shape memory, i.e. it is designed, after being deformed by thrust exerted by the needle 14, to return automatically, and without external action, to its normal configuration in which its shape substantially matches the shape of the wall 2B.
Preferably, the needle 21 is made by weaving a material that is substantially rigid, such as a metal or a hard plastics material, for example.
In particularly preferred manner, the membrane 21 is constituted by chain-mail, with the size of the links being selected to prevent a hollow needle 14 passing therethrough.
In particularly preferred manner, and as shown in FIG. 20, the membrane 21 floats freely within the chamber 2A, i.e. it is not constrained to occupy a predetermined position.
Advantageously, and as naturally applies to a membrane made of chain-mail, said membrane 21 is sufficiently porous to allow fluid to flow throughout the chamber 2A.
Naturally, it is possible to envisage that the membrane 21 is impermeable and is secured to the wall 2B, without thereby going beyond the ambit of the invention.
In another embodiment shown in FIG. 19, the screen 13 advantageously comprises a plurality of particulate elements 22 disposed freely within the chamber 2A, said particulate elements 22 being present in sufficient number to ensure that inserting the hollow needle 14 into the chamber 2A causes the particulate elements 22 to become mutually jammed against one another, at least locally, thereby together forming a stop for the needle 14 and preventing it from advancing.
In other words, the number of particulate elements 22 is selected so that said particulate elements occupy substantially the entire volume available inside the chamber 2A with the exception of a volume fraction corresponding approximately to the volume of the 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 freedom, whereas when the needle 14 is inserting into the chamber 2A, substantially all of the volume available inside the chamber 2A is occupied, thereby having the effect of blocking the particulate elements 22 in position relative to one another, thus preventing any progress of the needle 14 that might lead to it passing right through the puncture zone 7.
Advantageously, the particulate elements 22 are substantially spherical in shape, it being understood that the invention is not limited to a specific shape for the particulate elements, which elements may equally well be polygonal, for example.
Advantageously, the particulate elements 22 are made of a material that is rigid and strong, such as a hard plastics material or a metal.
In another embodiment, four subvariants of which are shown in FIGS. 20 to 26, the screen 13 presents a first face 23 disposed facing the wall of the chamber 2B and an opposite, second face 24. Said first face 23 is provided with access means 25 allowing the hollow needle 14 to pass through the screen 13 going from the first face 23 towards the second face 24, so that the hollow needle 14 can pass right through the screen 13, whereas the second face 24 is provided with blocking means 26 to prevent the needle 14 from passing through the screen 13 going from the second face 24 towards the first face 23.
In other words, the screen 13 of the variant embodiments shown in FIGS. 20 to 26 can be pierced in one direction only, going from its outside face towards its inside face.
By means of this technical measure and as shown in particular in FIG. 22, it thus suffices to place two portions 130, 131 of screen 13 facing each other so that their respective second faces 24 are facing each other.
In this configuration, the needle 14 can pass right through one of the two portions 130 of the screen 13 going from its first face 23 towards its second face 24, but will be blocked against the second face 24 of the second portion 131 of screen 13, since said second face 24 is provided with blocking means that prevent the needle 14 from passing through the screen 13 going from the second face 24 towards the first face 23.
This embodiment is thus particularly well adapted to a puncture zone 7 extending around 360° of the housing 2, since it then suffices to line the inside wall 2B of the chamber 2A with the screen 13 (cf. FIG. 21) so as to obtain the looked-for “intelligent shield” effect.
The invention corresponding to the embodiment of FIGS. 20 to 26 thus relies on the screen 13 being pierced in part, said screen 13 being provided with a first face 23 that can be pierced, and with an opposite, second face 24 that cannot be pierced.
In the variant embodiment shown in FIG. 21, the screen 13 advantageously comprises a series of unitary elements 27 disposed side by side and urged resiliently against one another. The elements 27 thus together form an elastically deformable sheet. Each unitary element 27 is made of a material that is sufficiently strong to prevent it being pierced by the needle 14. In particular, each unitary element 27 is preferably rigid.
The unitary elements 27 co-operate to define between them in pairs, and facing the wall of the chamber 2B, converging channels 27A for receiving the hollow needle 14, such that when the hollow needle 14 is inserted into a converging channel 27A, as shown in FIG. 22, that leads to the corresponding elements 27 moving apart, thereby enabling the needle 14 to pass into the chamber 2A.
The set of converging channels 27A thus forms the first face 23 of the screen 13, i.e. the face enabling the needle 14 to be inserted and pass in.
In the variant embodiments shown in FIGS. 21 and 22, the element 27 also co-operate to define between one another in pairs, opposite from the converging path 27A, an obstacle 27B preventing the needle 14 from passing between them. The set of obstacles 27B thus forms the second face 23, which second face 23 substantially prevents any penetration of the needle 14 into and through the screen 13.
Preferably, and as shown in FIG. 21, the unitary elements 27 present a cross-section of substantially triangular shape and they are resiliently connected to one another to form a circularly cylindrical sheet, matching the cylindrical shape of the chamber wall 2B, the puncture zone extending continuously over said wall 2B.
Each unitary element 27 of triangular section presents, in cross-section, a base from which two sides extend that meet at a vertex. The triangular elements 27 are resiliently connected to one another so that the bases of the elements 27 extend continuously from one to another, thereby forming a surface that is substantially smooth and uniform. This smooth and uniform surface constitutes the second face 24, which second face 24 by its smooth and solid nature does not allow the needle 14 to find a passage between the triangular elements 27.
On the opposite side, the sides of the triangle extending from the base act in pairs to define interstitial spaces of substantially triangular shape in cross-section, each interstitial space converging towards the inside of the chamber 2A.
When the needle 14 is inserted and pushed into one of the interstitial spaces forming a converging path 27A, it is capable of moving the elements 27 apart so as to open up a path to the inside of the chamber 2A. Nevertheless, the needle 14 cannot again pierce the membrane 7, since it is stopped on its path by the second face 24, as shown in FIG. 22.
Advantageously, the base of each triangle is of a shape that enables the obstacle effect of the second face 24 to be improved.
For example, as shown in FIG. 22, the base of each element 27 may include a lip 27B projecting from one of its ends, while at its other end it presents a recess 27C of shape complementary to that of the lip 27B, so that the triangular elements 27 can engage mutually one in the other. Such engagement, shown in FIG. 22, increases the reliability of the obstacle function performed by the second face 24.
In another variant, two subvariants of which are shown firstly in FIG. 23 and secondly in FIGS. 24 and 25, the screen 13 comprises a plurality of tubular elements 28 each of substantially converging shape, said elements 28 preferably being substantially identical and made of a material that cannot be pierced by the hollow needle 14, which material is preferably substantially rigid.
The elements 28 are engaged one in another so as to form a substantially tubular structure presenting an outside face forming the first face 23, and an inside face forming the second face 24.
Preferably, and 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 one another by a link thread 29, e.g. in the form of a flexible cord secured to each element 28.
Naturally, it is possible to envisage implementing other means for keeping the elements 28 in position, and for example making use of two end plates, situated at respective ends of the stack of elements 28.
In the variant of FIG. 23, the stack of elements 28 is disposed freely within the chamber 2A, with the dimensions of the stack being selected relative to those of the chamber 2A in such a manner that said stack matches substantially the inside of the chamber 2A, and can take on only an orientation that is coaxial with that of said chamber.
Without thereby going beyond the ambit of the invention, it is naturally possible to envisage the tubular elements 28 being held in position inside the chamber 2A, e.g. by being connected to the endpiece 3A for connection to the catheter 3.
It is also possible to envisage that the membrane 7 forming the wall of the chamber 2B is molded directly onto the stack of tubular elements 28, or is merely secured to said stack by adhesive.
As shown in FIG. 24, it is also possible to provide a tubular sleeve 30 placed within the chamber 2A, coaxially therewith, the elements 28 being engaged and held on said tubular sleeve 30, which sleeve is preferably made of a material that can be pierced by the hollow needle, such as silicone.
This embodiment operates as follows.
After passing through the puncture membrane 7, the needle 14 can slide into the interstitial space that exists between two tubular elements 28, which interstitial space is encouraged by the converging shape of each of the tubular elements. The needle 14 then passes through the sleeve 30 (if such a sleeve is provided) and penetrates into the chamber 2A, thus enabling the desired fluid injection or suction operation to be performed.
Assuming that the needle 14 continues its stroke, it will come into abutment against the face 24 at an orientation that prevents the needle from passing beyond the screen 13 and piercing the membrane 7. The orientation of the needle 14 is controlled by the converging orientation of the elements 28, a converging orientation that constrains the needle to adopt an oblique path that is substantially parallel (ignoring clearance) to the shape of the elements 28. As can be seen in particular in FIG. 24, the orientation of the needle 14 controlled by the first face 23 ensures that said needle 14 cannot slide into an interstitial space between the elements 28 on reaching the second face 24 since the interstitial spaces between the elements of the second face 24 are at an orientation that is symmetrical to the orientation of the needle 14 about the axis of symmetry of the chamber 2A.
Naturally, the invention is not limited to implementing tubular elements, but extends more generally to implementing two sloping stacks of sheets disposed symmetrically within the chamber 2A, the first stack forming the face 23 and allowing the needle 14 to pass in a predetermined oblique direction, while the second stack blocks the travel of the needle.
In this embodiment, the invention relies on lining the inside of the puncture zone 7 with a series of scales, said scales allowing the needle to pass through in one predetermined direction only.
In an alternative embodiment of the invention, as shown in FIG. 26, the screen 13 advantageously comprises a plurality of slats 31 disposed so as to overlap one another in part, presenting a substantially tubular outline having an outside face that forms the first face 23 and an inside face that forms the second face 24. Consequently, the general technical principle underlying this embodiment is similar, or at least very close to that implemented by the variants of FIGS. 23 to 25, since it likewise relies on making a system of scales, which scales are constituted by the slats that are substantially incapable of being pierced by the hollow needle 14. Said slats are preferably rigid, for example being made of a metal such as steel or titanium.
In particular, each slat 31 is advantageously constituted by a strip of metal foil.
The slats 31 are disposed so as to overlap one another in part, so as to define, as in the variants of FIGS. 23 and 24, a path for passing the needle 14 in a predetermined oblique direction, which direction is incompatible with the needle penetrating the second face 24.
Without going beyond the ambit of the invention, it is entirely possible to envisage the screen 13 in the variants described above and shown in FIGS. 17, 18, and 20 to 26 being integrated completely or in part directly within the wall of the chamber 2B. In other words, in this configuration, the elements forming the screen 13 are advantageously embedded in the structure of the wall 2B, which is preferably formed directly by the “septum” membrane forming the puncture zone 7. This technical measure can be used in particular for maintaining the screen-forming elements 13 in position relative to one another without using any additional means such as the thread 29 or the sleeve 30 being necessary. Preferably, when the elements forming the screen 13 are embedded in the puncture membrane, said elements are embedded at a distance from the surface of the wall 2B that is small enough to ensure that when the hollow needle 14 is in abutment against the screen 13, its orifice, which conventionally opens out in a chamfer at the tip of the needle, is not closed and opens out into the chamber 2A.
Naturally, the use of a screen 13 is purely optional.
There follows a description in greater detail of the embodiment shown in FIGS. 11 and 12 which relates to a hypodermic device 1 for injecting medication into a vein 11 (or an artery) and/or for taking blood from said vein 11 (or artery), said device 1 thus forming an artificial vein or artery.
The device 1 in accordance with this embodiment seeks to imitate a natural vein in realistic manner so as to take the place thereof for operations of injecting medication intravenously or operations of taking blood.
For this purpose, the device 1 substantially reproduces the shape of a portion of a natural vein, i.e. it is in the form of an elongate tubular housing, e.g. made entirely out of a pierceable material, of the silicone type.
The device 1 as made in this way is for lying flush under the skin of the patient, above the vein 11 to which it is connected.
The device 1 in accordance with this embodiment is for being pierced in the same manner as a natural vein, i.e. at a grazing angle relative to the patient's skin, and not perpendicularly as when piercing a prior art site. Such “tangential” piercing means that the presence of the screen 13 is not absolutely necessary.
Nevertheless, such a screen can be envisaged, as is shown in the variants of FIGS. 11 and 12.
In this variant, the distal wall 5 is substantially plane and is defined laterally by two side edges 5A, 5B, while the proximal wall 4 and the side wall 6 contributes together to forming a surface of revolution, e.g. semicircular, interconnecting said side edges 5A, 5B.
The screen 13 constitutes a gutter, made of a material that cannot be pierced by the needle 14, but that is preferably flexible. Said gutter advantageously presents a channel section, with the web on the channel section resting in the chamber 2A on the distal wall 5, while the flanges of the channel section are upstanding against the side wall 6.
The concept of an artificial vein developed in the ambit of the present invention presents a character that is quite independent of the other applications mentioned above.
Finally, it should be observed that the housing 2 may advantageously be radio-opaque, by including an appropriate marker substance in its internal structure, either uniformly or otherwise.

SUSCEPTIBILITY OF INDUSTRIAL APPLICATION

The invention finds its application in making and using implantable sites for injecting and/or extracting fluid.

Claims

1. An implantable device for injecting and/or extracting fluid either into or from an organ or vessel of the body of a human or animal patient, or into or from an inflatable and/or deflatable compartment of a surgical implant, said device comprising:

(a) a housing having

(i) a chamber connected to a catheter, wherein the catheter is connected either to the organ or vessel or to the compartment,

(ii) a proximal wall and a distal wall with a side wall extending between the proximal wall and the distal wall,

(iii) a puncture zone capable of being pierced by a hollow needle to inject and/or extract fluid into or from the chamber,

the puncture zone being shaped as to extend simultaneously at least over the proximal wall, the side wall, and the distal wall; and

(b) a screen made of a material that is not pierceable by the hollow needle and is located within the chamber to prevent the housing from being pierced through by the hollow needle.

2. The device of claim 1, wherein the distal wall is substantially planar and is defined laterally by two side edges, while the proximal wall and the side wall form a surface of revolution interconnecting the side edges.

3. The device of claim 1, wherein the proximal, distal, and side walls form a surface that is substantially polyhedral.

4. The device of claim 1, further comprising a duct connecting the chamber to the outside of the device, the duct extending longitudinally along a first axis and connecting to the catheter, proximal, distal, and side walls being shaped and arranged so that the housing substantially presents symmetry about a second axis, the second axis is substantially parallel to the first axis.

5. The device of claim 4, wherein the proximal, distal, and side walls form a surface that is substantially spherical.

6. The device of claim 4, wherein the proximal, distal, and side walls form a surface that is substantially ovoid.

7. The device of claim 4, wherein the proximal, distal, and side walls form a surface that is substantially pear-shaped.

8. The device of claim 4, wherein the proximal, distal, and side walls form a surface that is substantially cylindrical.

9. The device of claim 1, wherein the puncture zone extends over substantially all of the proximal, side, and distal walls.

10. The device claim 1, wherein the puncture zone comprises a self-sealing membrane.

11. The device of claim 1, wherein the housing is constructed from a frame made of a material that is substantially not pierceable by the hollow needle and is covered by at least one envelope made of a self-sealing material, the frame is pierced so that, in cooperation with the envelope, the frame forms the puncture zone.

12. The device of claim 11, wherein the frame is substantially rigid lattice.

13. The device of claim 1, wherein the screen is a wheel having at least one blade.

14. The device of claim 13, wherein the blades wheels comprises at least four blades which are at least four in number, and are regularly spaced apart angularly.

15. The device of claim 13, wherein the bladed wheel is mounted to rotate within the chamber.

16. The device of claim 1, wherein the chamber is defined by a chamber wall, and the screen comprises at least one stop panel for the hollow needle mounted to bear slidably against the wall of the chamber in such a manner that the wall can be moved within the chamber under the effect of thrust exerted by the hollow needle.

17. The device of claim 1, wherein the chamber is defined by a chamber wall, and the screen comprises at least one stop panel for the hollow needle, the panel being deformable under the effect of thrust exerted by the hollow needle.

18. The device of claim 17, wherein the panel is deformable in bending.

19. The device of claim 17, wherein the panel comprises a plurality of substantially rigid unitary elements linked by flexible links to form the panel.

20. The device of claim 1, wherein the screen comprises a flexible membrane of shape that substantially matches the shape of the wall of the chamber, the membrane being disposed freely within the chamber and being deformable under the effect of thrust exerted by the hollow needle.

21. The device of claim 20, wherein the membrane presents shape memory.

22. The device of claim 20, wherein the membrane is made by weaving a substantially rigid material.

23. The device of claim 1, wherein the chamber is defined by a chamber wall, and the screen presents a first face facing the chamber wall and an opposite second face, the first face is provided with access means allowing the hollow needle to pass through the screen in the first face to second face direction, while the second face is provided with blocking means for preventing the needle from passing through the screen in the second face to first face direction.

24. The device of claim 23, wherein the screen comprises a series of unitary elements disposed side by side and urged resiliently against one another, the elements cooperating in pairs to define between them and facing the wall of the chamber corresponding converging paths for the hollow needle such that inserting the hollow needle into a converging path leads to the corresponding elements being spaced apart relative to each other, thereby enabling the needle to pass into the chamber, the set of convergent paths forming the first face, the unitary elements also cooperating in pairs, opposite from the converging paths, to define between them obstacles to the needle passing between them, the set of obstacles forming the second face.

25. The device of claim 23, wherein the screen comprises a plurality of tubular elements of substantially converging shape engaged one in another, to form a substantially tubular structure presenting an outside face forming the first face and an inside face forming the second face.

26. The device of claim 23, wherein the screen comprises a plurality of slats that overlap one another in part around a substantially tubular outline presenting an outside face, forming the first face, and an inside face, forming the second face.

27. The device of claim 1, wherein the screen comprises a plurality of particulate elements disposed freely within the chamber, the particulate elements being present in sufficient number for insertion of the hollow needle into the chamber to lead, at least locally, to the particulate elements blocking mutually against one another, thereby together forming a stop assembly for the needle.

28. The implantable device of claim 1, wherein the surgical implant comprises a gastroplasty ring.

29. An implantable device for injecting medication into a vein or an artery and/or for taking blood from vein or artery, thereby forming an artificial vein or artery the device comprising:

(a) a housing having

(i) a chamber connected to a catheter, wherein the catheter is connected either to the organ or vessel or to the compartment.

(ii) a proximal wall and a distal wall with a side wall extending between the proximal wall and the distal wall.

(iii) a puncture zone capable of being pierced by a hollow needle to inject and/or extract fluid into or from the chamber, the puncture zone being shaped as to extend simultaneously at least over the proximal wall, the side wall, and the distal wall: and