FR2718355A1 - Rotary head perfusion instrument for introduction of liquid to body without contamination - Google Patents

Abstract

The instrument has a fixed puncturing point (1) which includes a blockable air inlet (2) with an anti-moisture filter (3) and is connected to a liquid supply tube (8). The point, air inlet and filter are fixed relative to the supply tube, which is rotatably mounted via a stopper (9) and ring (11) to a liquid droplet chamber (16). The connection of the supply tube to the chamber includes a toroidal seal (10). A rotary drive force is imparted to the supply tube and point assembly via the liquid transmitted through a spiral tube (17) to the droplet chamber. The point is protected by a sealed cover (13) ensuring a sterile environment surrounding it.

Description

ROTARY HEAD PERFUSER and ANTI-CONTAMINATION PROTECTOR
Too many accidents, sometimes with a fatal outcome, occur at the conclusion of a stay in a hospital or clinical environment.

 How many patients are struck by complications of all kinds, having no direct relation to the care provided.

This type of contamination is part of Nosocomial Infections.

 A few years ago, I was developing a new infusion set with a rotary puncture needle and an integrated rotating air filter.

Following a sterility study of the solutes injected with this type of device, carried out jointly by a laboratory
Departmental veterinary analyzes, as well as by a CHRU
French, it turned out that a fairly high level of contamination was evident in a part of the liquid that remained voluntarily in the bottles (48% during the first infusion, and 98% during the second infusion, with use from the same infusion line).

 I then acquired the certainty that the serum could be contaminated 10 in the rotary junction of the air filter, 20 during the perforation of the rubber stopper of the bottle, by the tip of an infusor extracted from its sterile packaging.

 Identical bottles perforated under laminar flow showed no contamination.

 It is therefore certain that the rotation of the filter pad cannot have a cutout, as well as a support whose interstices are at most equal to 0.22 micron, which is the specific retention condition of the filter. The play in rotation is much greater than this, hence the presence of microbes in the solutes.

 The problem is insoluble, the rotation having to benefit from a minimum friction in order to avoid any tightening, whereas conversely a maximum pressure would be necessary in order to avoid any spacing of more than 0.22 micron, between the pellet filter and its seat.

 On the other hand, the filter / seat surfaces should be surfaced in the same way as a 0.22 micron mirror, while one of the parts is made of injected plastic. The injection mold is machined to a precision of 1 / 100th of a m / m dimension which represents 50 times the value of the filter. Knowing that a microbe has an average diameter equal to 1 micron, the effect of the rotary filter is negative.

 Part of the air passes through the filter, and another part bypasses the same filter through the interstices of the rotation.

 On the other hand, the very short time for the passage of the puncture point of an infusion set, between its removal from its sterile packaging, and, the introduction of this same point into the serum bottle, is sufficient to introduce quantity of germs in the liquid.

 Then by flow in the patient's vein, the germs are transmitted directly into the blood network; the usual defenses: respiratory, digestive, etc. are thus bypassed.

 The patient, who is often in a state of immune deficiency, is all the more easy prey for infections, and the fight sometimes ineffective.

 The rotary function of an infuser represents an improvement in the medical plan and comfort of certain patients, I studied a new system of rotation avoiding the defect quoted above, as well as another process allowing the needle of puncture dedemeu-rer in a sterile state until the perforation of the solution bottle; these two improvements avoid contamination of the injected liquid and thereby reduce the rate of nosocomial infections transmitted by infusions.

 The present invention seeks to remedy the two drawbacks mentioned by providing related solutions.

A first nonlimiting example of this new perfuser created to avoid the filtration defect Fig I consists of a fixed puncture point (1) with air inlet (2) additionally closable, provided with a hydrophobic tablet equal to 0 , 22 micron (3). On the outlet tube (8) of the tip (l) is mounted a plug (9) on which is stuck a conventional drop chamber (16). On the tube (8) against the plug (9) is arranged a flexible medical rubber O-ring (10), held in place by a ring (11) itself assembled on the
said tube (8). The O-ring (10) is made of a rubber
flexible enough to ensure a perfect seal between the plug (9)
and the tube (8) .The plug (9) comes to rest on the ring (11)
by a traction exerted by the spiral tube (17) in connection
with the chamber (16). The spiral tube (17) integral
of the invention serves at the same time for the transmission of force
drive the rotation of the part (9), the source of this
force being provided by the patient being infused either
human or animal, depending on movements or rotations.

It should be noted that room (16) does not fall within the framework
of this patent this type of part from the trade. The
type of seal (10) is specially designed to ensure
perfect seal as a rotating joint. In a second
example Fig. II always nonlimiting, the seal (10) as well as
the ring (11) are replaced by a single piece of rubber
chouc (20) representing a lip seal in its upper part
followed by a tube serving as a dropper, visible at the
across the chamber (16).

As for the perforation part of the bottle cap, by the
tip (1) the third part of the invention consists of a
special protector covering the puncture needle (1) of the
infuser. This protector to be pierced by the tip
(1) at the same time as the rubber stopper of the bottle,
resting against each other.

In a description of the principle, non-limiting, taken into account
example, the protector object of the present invention Fig.I-II
consists of a latex tube (12) or other flexible material
and extra-thin admitted for medical use; closed in part
upper (13) and, terminated at its base by a small bead
ring-shaped (14).

This protector is forced into place on the sanding needle
tion (1) during manufacture, the base bead (14)
serving as a sealing ring.

Without departing from the scope of this patent, the sealing can
be obtained by any other known or future process.
seems is then packaged and then sterilized.

 When removing the infuser from its sterile packaging, only the outer part of the protector (12) will be in contact with the polluted ambient air; but on the other hand the needle (1) trapped in the protector (12) will remain in a sterile space (15).

The puncture needle (1) will thus pass from its sterile enclosure (12) into the liquid without any other external contact
I1 remains understood that any form, any kind, any structure and any different use tending to the same result as the example above, would be within the scope of the present invention.

 Not limiting to the use described by way of example, the invention can be adapted to the protection of all medical or scientific instruments taken out of a sterile enclosure, up to their place of use.

 This type of protector is particularly intended for medical uses and for any intervention in a contaminated environment with instruments: sharp, sharp, perforating, extracted from their sterile environment.

Claims (9)

 I - Perfusor with rotary chamber and anti-contamination protector, comprising a fixed puncture point (1) equipped with a closable air inlet (2) provided with a hydrophobic tablet (3) terminated by a flow tube ( 8) of the liquid to be perfused, characterized in that the assembly point (1) air intake (2) and filter (3) remaining fixed relative to the stopper of the bottle which it pierces avoids any leakage or entry of air unfiltered; mounted on the tube (8) a rotary plug (9) is supported on a ring (11) secured to the tube (8) by means of a thoracic seal (10); the force for driving the rotation of the part (9) being transmitted to the latter via the spiral tube (17) associated with the drop chamber (16) and the tip (1) enclosed in a protector ( 12) closed at (13) terminated by a bead (14) is thus in an enclosure capable of remaining sterile (15).  2 - Perfusor with rotary chamber and anti-contamination protector according to claim 1 characterized in that the part (9) forms support on the ring (11) through the thoracic joint (10) by pulling the spiral (17) through the bedroom (16)  3 - Perfusor with rotary chamber and anti-contamination protector according to claim 1 characterized in that the seal (10) is formed of material admitted in mediacl, however flexible enough to match any roughness or surface unevenness between the parts (8) - (9) - (11) and thus ensure a perfect seal between the said parts.  4 - Perfusor with rotary chamber and anti-contamination protector according to claim 1 characterized in that the part (9) is arranged so as to allow the mounting of a drop chamber (16) of a standard model.  5 - Perfusor with rotary chamber and anti-contamination protector according to claim 1 characterized in that the rotation of the part (9) is controlled by the force transmitted by the tube (17) in connection with the chamber (16).  6 - Perfusor with rotary chamber and anti-contamination protector according to claim 1 characterized in that the spiral tube (17) is made of a material endowed with an elastic memory suitable for this use and in accordance with the new European standards of the pharmacopoeia.  7 - Perfusor with rotary chamber and anti-contamination protector according to claim 1 characterized in that the protector (12) forms a sealed enclosure retaining an independent space (15) which can be made sterile, thus creating a  anti-contamination atmosphere of the tip (1).  8- Perfusor with rotary chamber and anti-contamination protector according to claim 1 characterized in that the protector (12) is terminated at its upper end by a half-sphere (13) and at the other end on the base side by a bead seal (14) forming a tightening on the base of the tip (1).  9 - Perfusor with rotary chamber and anti-contamination protector according to claims 7-8 characterized in that the protector (12) must be made of a material admitted for medical use, flexible and perfectly waterproof, but punctured by the tip (1 ) pressing against the rubber stopper of the bottle of liquid to be infused. The latex is perfectly suitable for this use.