FR2571260A1 - Improved device for access to blood vessels and other ducts for circulating biological fluids - Google Patents

Abstract

The invention relates to an implantable module for access to blood vessels and other biological ducts of a living organism consisting: a. of a hollow cylindrical body 1 whose lower part S comprises on the one hand a slit 2-3 opening out into a lateral duct C and on the other hand, at least one slit 2a-3a opening out into an attached volume C1; b. of a part 6 exactly matching the shape of the internal wall of the cylinder 1, this part being capable of a rotational movement and being passed through longitudinally by two channels 9-10 whose ends 9a-10a are intended to interact with the slits 2-3 or 2a-3a; c. means 5 for rotational control and connecting up to any external circuits desired.

Description

 The present invention relates to an improved device intended for living organisms for access to blood vessels and other conduits for the circulation of biological fluids, the purpose of this device being to allow the removal from these vessels or conduits of the biological fluid circulating therein, and / or the injection into these vessels or conduits of other liquids.

 We already know a certain number of vascular access devices or modules mainly consisting of generally cylindrical hollow bodies, inside which can be operated, like a "tap", another piece also cylindrical crossed by channels, the lower ends of which may or may not communicate with a conduit intended to be implanted in a living organism to be connected to a vessel of the blood circulatory system or other conduit for circulation of biological fluid and the upper ends of which communicate with the outside with any circuit allowing a withdrawal of the envisaged fluid.

 Mention will be made, among others, of devices or modules of this type as described in French patents 2,327,800, 2,378,525, 2,387,043 and 2,387,044.

 These devices or modules are intended to remain permanently implanted in the subject from which such samples must be taken, as is the case for example, in subjects or patients forced to undergo frequent extracorporeal circulation, for the purpose of '' biological purification as for example in the case of patients suffering from renal or hepatic insufficiency.

 It is thus possible to improve the comfort of the subjects to be treated by avoiding unnecessary suffering and ailments which can be caused by conventional punctures or injections, by means of needles.

Clinically, by thus eliminating such punctures or repeated injections, in particular in subjects or patients on dialysis, a deterioration of the vascular walls is avoided.

 Although these devices or modules meet the desired goal, they do not, however, by their structure, achieve either cleaning, or washing the pipes in communication with the vessels or conduits of 1 organism, or a treatment operation external blood or fluid collection, either an isolated or concomitant injection into the bloodstream, without the need to interrupt the external circuit.

 However, the present invention provides such a device having the advantage of being able to carry out all of these operations without interrupting the circulation external to the body.

The device or module according to the invention is therefore essentially characterized in that it is constituted
a) of a hollow cylindrical body ending at its lower part with a hemispherical or conical surface comprising, on the one hand, at least one lumen opening out of this cylindrical body in a lateral pipe integral with said cylindrical body hollow and, on the other hand, to the kidney a light emerging in an added volume, made integral, in a sealed manner, of said hollow cylindrical body
b) of an equally cylindrical part, the shape of which exactly matches that of the internal wall of said hollow cylindrical body, so as to be able to accomplish a rotation movement with gentle friction bearing on said wall, said part being longitudinally traversed by two channels whose lower ends are intended to coincide with either the lumen of said hollow cylindrical body opening onto said lateral pipe, or with the lumen opening of said volume.
c) means carried by the upper part of said cylindrical part to, on the one hand, allow its rotation and, on the other hand, to allow connections to any desired external circuits.

 According to other characteristics, the above device or module is designed to be implanted in a limb or an organ of the subject on which fluid must be taken and / or injected with liquids, and the lateral pipe associated with the body cylindrical hollow is designed to be able to be connected to the blood vessel or the biological duct in question.

Other characteristics and advantages of the invention will emerge more clearly from the description which follows, made with reference to the appended drawings in which
- Figure 1 is a sectional elevation view of a module according to 1 invention shown with its two essential constituent parts, separated from one another
- Figure 2 is a sectional view along Il-Il of Figure 5 of a module, with its two component parts mounted in one of their respective respective positions
- Figure 3 is a sectional elevation view along III-III of Figure 1
- Figure 4 is an elevation-sectional view of a module vertically implanted in a living organism, the constituent elements being in one of their possible positions
- Figure 5 is a view similar to Figure 4 in the other of the possible positions of the components
- Figures 6 to 9 are schematic views showing the possibilities of using the device according to the invention.

 Referring to these figures, the device or module according to the invention consists of two essential elements, namely a first element which is advantageously a hollow cylindrical body 1 terminated at its lower part by a surface portion S, of hemispherical shape or conical, comprising at least one lumen or two adjacent openings 2-3 opening into a conduit C (intended to be inserted into a blood vessel or any other conduit of biological fluid), made integral with said cylindrical body 1, the axis of this conduit C which may be orthogonal to the axis of this cylindrical body 1 or incline relative to it, as illustrated in FIG. 1. In addition, the lower part of said hollow cylindrical body 1 comprises at least one lumen or two orifices 2a -3a emerging in a volume C1 whose role will emerge below. The outer wall of this hollow body is provided with a perforated bag # ue 4 whose role will emerge from the description made later for the installation of the device according to the invention. The upper part of this body 1 is provided with a sleeve 5, the rail of which will also emerge from the description which follows.

This body 1 is intended to receive the second essential element of this device, namely a cylinder 6 whose external shape is designed so as to be able to exactly match the shape of the lower surface of the body 1, particularly in the hemispherical or conical part. S, while having the possibility of turning around its axis, this rotary drive being effected by means of the sleeve 5 engaging the upper part of said cylinder 6, this sleeve being judiciously threaded at 7 to cooperate with a corresponding thread 8 planned to
the upper part of the body 1. The cylinder 6 is
crossed over its entire length by two channels 9 and 10.

Advantageously, the lower part Sa-1Oa of these
channels is possibly slightly curved, so as to be able to coincide with the lights or
holes 2-3 and 2a-3a provided on the surface S of the body
hollow 1. The upper part of these two channels is intended to be able to be connected to the conduits of an extracorporeal circulation system, as will be seen
below.

We use the module or device that comes
to be described as follows
After installing this device in a
organ or limb, as illustrated in Figure 5, in
connecting the conduit C to a natural vessel T of the
subject's blood system. The device is kept in
place within the dermis D of said subject thanks to the ring
perforated i, as it is known per se.

When the lower ends of
channels 9 and 10 are in one position
intermediate between ports 2-3 and 2a-3a, none
circulation of fluid or liquid from
outside or from the T vessel is not possible. On the other hand.

if by acting on the sleeve 5, the
cylinder 6 in a position, for example that illustrated in FIGS. 2 and 5, a circulation of fluid or liquid is possible, since the orifices of the channels 9 and 10 are in direct contact with the
current of the fluid circulating in the conduit C in connection
with vessel T. In this position, a continuous sampling or liquid injection operation is
possible.

 When the movable cylinder 6 is rotated so as to bring the lower ends of the channels 9 and 10 opposite the window or the orifices 2a-3a, as illustrated in FIGS. 3 and 4, no evacuation of blood or biological fluid towards outside is not possible; on the other hand, an external liquid can be circulated. This is the case for washing or rinsing, or even the closed circuit flow of a fluid previously taken for treatment outside the body and before its possible reinjection.

 The module or apparatus according to the invention thus allows access from the outside to the blood vessels and other biological conduits to evacuate and / or treat the fluids of these vessels and / or to inject physiological fluids therein without interrupting the operating mode of the external circuit, as will be seen from what follows.

 Referring to Figures 6 and 7, there is illustrated thereon the case of filling the ducts of the system applying the device of the invention and / or rinsing the pipes, for example of a dialyzer. The module according to the invention is designated by the reference A and the blood for example of a patient circulating in the vessel T in connection with the conduit C of the module of the invention, is shown diagrammatically by the arrow F. The channels 9 and 10 of the module are connected to the pipes 11 and 12 of a dialyzer assembly comprising the dialyzer itself, V, with its dialysis bath circuit 8, a pump P itself connected by means of a two-way tap R, for example a bottle of physiological saline (or any other suitable liquid) L.

 As usual, this set obviously includes an air intake G. One of the phases of the line filling and rinsing operation consists first of all in bringing the vascular access module in the closed position, c 'that is to say that the two channels 9 and 10 communicate with the added volume Cl, as shown in Figure 6. The two-way valve R is in the position illustrated in this figure and the pump P is running. We immediately realize that the liquid contained in the bottle L follows the circuit according to the arrows fi. If it is a rinse aid, it can be drained at E.

In this way, it can be seen that there was no need to interrupt the operation of the dialyzer and therefore to disconnect the vascular access module during this rinsing. Once this rinsing has been carried out, it suffices, with the pump still running, to bring the two-way tap R to the position shown in FIG. 7.

We can then see that the circulation of the dialyzer fluid is done autonomously, passing through module A.

 Still without interrupting this circulation, it is possible to carry out an extracorporeal circulation of the blood during a treatment such as hemodialysis, hemofiltration,. plasmaadsorption, hemoperfusion, plasmapheresis, etc.

 The vascular access module is brought into the so-called open position, as illustrated in FIG. 8. The pump P is running and the two-way valve R is in the position shown in this figure, the corresponding outlet of the pipe connected to the liquid L being closed as seen in this figure. The blood is purified in the dialyzer V, for example by using the circuit designated by the arrows f2.

 In the same way, and with reference to FIG. 9, the tap R being in the position shown in this figure, it is possible, while not stopping the operation of the external circuit, to inject into the blood vessel T, at the same time time as the appropriate liquid L, by intervening by means of any suitable device such as a syringe H any additional liquid desired.

 The vascular access module which has just been described thus makes it possible to carry out all the treatments, whether as part of a sample or as part of a continuous or punctual injection, without in any way interfering with the functioning of the delivery system. circulation outside the patient under treatment, while currently known methods and devices do not allow it.

 It goes without saying that the present invention has only been described for explanatory purposes and is in no way limitative and that any useful modification, in particular in terms of equivalences, may be made thereto, without going beyond its ambit.

Claims (2)

 1. Implantable module for access to the blood vessels and other biological conduits of a living organism, essentially characterized by the fact that it is made up  a) of a hollow cylindrical body (1) ending at its lower part by a surface (S) of hemispherical or conical shape comprising on the one hand at least one lumen (2-3) opening out from this body in a lateral pipe (C) integral with said body and, on the other hand, by at least one lumen (2a-3a) opening into an added volume (C1) made integral, in leaktight manner, with said hollow cylindrical body  b) an equally cylindrical part (6) whose shape exactly matches that of the internal wall of said hollow cylindrical body, so as to be able to perform a rotation movement with gentle friction in abutment on said wall, said part being longitudinally traversed by two channels (9-10) whose lower ends <9a-I0a) are intended to coincide with either the lumen (2-3) of said hollow cylindrical body opening onto said lateral pipe (C), or with the lumen (2a -3a) leading to said volume (C1)  c) means (5) carried by the upper part of said cylindrical part (6) on the one hand to allow its rotation and, on the other hand, to allow connections (11-12) to any desired circuit.  2. Implantable module according to claim 1 characterized in that the lateral conduit (C) associated with said hollow cylindrical body (1) is designed to be able to be connected to a blood vessel or a biological conduit (T).