WO2010034901A2 - Gel adapted for transmitting ultrasound waves, method for making said gel, and bag containing same - Google Patents

Gel adapted for transmitting ultrasound waves, method for making said gel, and bag containing same Download PDF

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Publication number
WO2010034901A2
WO2010034901A2 PCT/FR2009/001115 FR2009001115W WO2010034901A2 WO 2010034901 A2 WO2010034901 A2 WO 2010034901A2 FR 2009001115 W FR2009001115 W FR 2009001115W WO 2010034901 A2 WO2010034901 A2 WO 2010034901A2
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WO
WIPO (PCT)
Prior art keywords
gel
sterile
probe
tubing
opening
Prior art date
Application number
PCT/FR2009/001115
Other languages
French (fr)
Other versions
WO2010034901A3 (en
Inventor
Frédéric Bosler
Original Assignee
Bosler Frederic
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bosler Frederic filed Critical Bosler Frederic
Priority to EP09741327A priority Critical patent/EP2379112A2/en
Publication of WO2010034901A2 publication Critical patent/WO2010034901A2/en
Publication of WO2010034901A3 publication Critical patent/WO2010034901A3/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42—Details of probe positioning or probe attachment to the patient
    • A61B8/4272—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue
    • A61B8/4281—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue characterised by sound-transmitting media or devices for coupling the transducer to the tissue

Definitions

  • the present invention relates to the transmission of ultrasonic waves for medical, paramedical and / or veterinary purposes.
  • the invention relates to a gel suitable for the transmission of ultrasonic waves, which probe nurse gel opening through at least one orifice near the transmission window and / or reception of the signals of a uitrasonique probe called DOPPLER effect and for which a gel-type interface adapted to the transmission of ultrasonic waves is an inalienable need to be operational.
  • These gels which are in colloidal solutions in semi-solid galenic form, are essential not only for obtaining an image but also for the quality of the latter, as will be apparent from the following description for locating said gel in the art. medical imaging by ultrasound.
  • the gel according to the invention used in ultrasound. It was mentioned as contained in its container in the registered patent application under No. 0 08/00475.
  • An ultrasound system consists of a probe allowing the emission and reception of ultrasound, a computer system exploiting the delay between the reception and the emission of the ultrasound image, a control console for the purpose of various settings, a monitor, an analog recording system and or digital data, all arranged on a mobile support to perform ultrasound examination in all circumstances attractive to the patient.
  • the basic element of ultrasound is an ultrasonic transducer assembly, a piezoelectric ceramic located in the probe and emitting ultrasound whose echoes are received in fundamental or harmonic mode, in linear mode or not, by this same ceramic.
  • the probes, of convex shape or of linear form or of micro convex shape, and hence the ultrasonic transducers vary according to the organ studied and or according to a targeted definition of a spatial but also temporal image.
  • a modern ultrasound probe now has up to 960 elements for conventional medical imaging, but easily reaches 3000 elements in cardiology. The next generations of probes will have more than 12000 piezoelectric elements with a successive emission on each transducer.
  • the frequency of ultrasound is a very important element: modulated it allows to have a more precise signal and affect the quality of an image and this explains the availability of several probes, for frequencies adapting in current use, for the sector deep with a definition of the order of a few millimeters; for intermediate structures with a resolution less than one millimeter; for the exploration of small structures close to the skin with a resolution close to a tenth of a millimeter; and frequencies above 10 MHz for superficial imaging.
  • the essential element for practicing ultrasound is the so-called ultrasonic gel. Indeed and for mechanical reasons, it is considered that the contact between the probe and the skin of the patient can not be perfect and that there is therefore a thin layer of air between the probe and the belly. It is then question of acoustic impedances of the air and the skin, in Pa. S / m whose values make it possible to calculate the value of the transmission coefficient of the air-skin interface. This value is very low and therefore generates a significant attenuation of the signal between the emission and the reception of the ultrasound by the probe.
  • Ultrasound is therefore required to pass with an interface such as a gel, whose acoustic impedance is close to that of the skin (T ⁇ 10-3), to increase the quality of the signal between the emission and the reception of ultrasounds.
  • an interface such as a gel, whose acoustic impedance is close to that of the skin (T ⁇ 10-3), to increase the quality of the signal between the emission and the reception of ultrasounds.
  • air is a disruptive factor; also any gel production is done taking care not to contaminate the gel, during its manufacture and during the conditioning of the gel, with air bubbles that would be irremediably trapped in the gel because of its viscosity.
  • ultrasound scanners corresponding to the foregoing description and to a gel dispensing device attached to or integrated with at least one transmitting and / or receiving signal probe, comprising a gel reservoir suitable for transmitting ultrasonic waves for acts medical, paramedical and / or veterinary services.
  • a gel reservoir suitable for transmitting ultrasonic waves for acts medical, paramedical and / or veterinary services.
  • Which gel comes from the reservoir integral with the probe and opens through at least one orifice near the window for transmitting and / or receiving signals from the emitter and / or receiver probe of said signals.
  • a right-handed operator simultaneously manipulates the probe of his right hand and actuates the commands of the peripherals and the keys of the keyboard of his left hand.
  • the performance and the quality of the result are directly a function of the synchronization of these actions. This is to indicate that the result of an ultrasound act, hence the spatial and temporal quality in ultrasound imaging, depends not only on the high technicality of the ultrasound system but also on the ultrasound system operator and the characteristics of the gel used
  • the prior art proposes among other things the abandonment of conventional freezing as well as a saving of time with a device comprising a fluid product which is poured onto a nonwoven compress, which is previously applied to the region. to ultrasound, leaving a film having the property of allowing the transmission of ultrasound. This film disappears spontaneously in a few minutes, without necessary cleaning.
  • the main use of the invention covers medical ultrasound for any user wishing to no longer use the conventional gel. But in use the implementation of the device has proved more complex in its use;
  • the sonographer therefore still has two categories of gel in the market for medical and pharmaceutical consumables; it is necessary to distinguish the gels composed of natural macromolecules of the family of celluloses gels composed of synthetic macromolecules of the family of carbomers.
  • the base of the compositions of such gels in colloidal solutions in semi-solid galenic form remains identical, since it is indeed a mixture of a macromolecular base and a preservative for the least and for the most added with therapeutic adjuvants, perfuming or dye or other of comfort and or care.
  • the operator faces multiple and imposed constraints both in terms of obtaining the quality of information necessary for an efficient and quality examination, as well as for the performance of his tool and for the profitability and the urgency of the examinations. Indeed, it is directly from and proportionally to the homogeneity and regularity of the gel layer disposed between the emission window and / or the reception of the signals and the external wall of the observed organism, that the results and the optimization of their characteristics.
  • the gel retains the same packaging and this is not done to improve its fluidity and viscosity once applied. Often it dries too quickly and it is unthinkable to add more water without making it unsuitable for its purpose. By drying it slips less and affects the duration of the examination, leaving the image to be taken again with a new application until it can ensure the diagnosis without doubts about the visual observations made.
  • Viscosity necessarily implies manipulation and in these repetitive and perpetual conditions for each examination; this does not go without affecting the state of health of the operators who see tendinitis and ultimately occupational diseases crippling the practice of ultrasound examination.
  • the health constraint is not neutral.
  • extensive microbiological screening in a hospital setting revealed contamination of Burkholderia cepacia in an ultrasound gel.
  • the ultrasound gel was a commercial product available in containers of 260 and 1000 ml. The manufacturer has been informed of the contamination. Indeed, there are international specialist publications describing Burkholderia cepacia contamination already during production. Only this example shows that the manufacture of the gel itself at viscosities suitable for the production of relevant ultrasound examinations respecting all the technical and legal parameters, lead to expensive manufacturing processes. To meet the current demand manufacturers produce under vacuum in controlled atmosphere and for economic reasons in minimal quantities of the order of 1000 liters.
  • This document D1 describes a gel suitable for the transmission of ultrasonic waves for the purposes of medical, paramedical and / or veterinary procedures, which gel is produced by at least one gel with natural macromolecules of the cellulose type and at least water (H 2 O), this gel is used in a vial because it can not be used in a pocket and therefore requires maintaining the patient in a sterile environment and the gel is sterilized by itself.
  • the gel of the invention is for probe nurse opening through at least one orifice near the window of transmission and / or reception of the signals of the probe.
  • This gel is at least achieved by the combination of at least one gel being with natural macromolecules of the cellulose type or synthetic carbomer type at least sterile water, production directly in sterile ambient atmosphere of said reformulated gels directly from each of the natural or synthetic macromolecules, alone or combined and in combination with sterile water, said gel being then isolated in a disposable flexible pouch, part of a closed circuit to allow a one-piece ultrasound act, continuously and efficiently, respecting all the codes of hygiene and sterile operating procedures recommended and or desired in the field and from the production of said gel
  • the gel of the invention being itself enclosed in a sterile nurse, it is no longer necessary for the patient to be in a sterile environment.
  • the gels according to the invention differ from those known by D1, because their function is to comply with all hygiene codes.
  • the document FR A 2,770,402 also describes a gel made for bottles. Ii corresponds to that of document WO 2007/038855 A1, further comprising stirring and resting steps.
  • the invention contrary to the state of the art solves the problem allow an act of ultrasound in one piece, without contact of the gel with the ambient air before the skin.
  • the invention as newly claimed in 1 solves the problem allowing an ultrasound act in one piece, without contact of the gel with the ambient air before the skin.
  • the invention aims to take into consideration and fully all these aspects and problems and to respond with a single global solution with concrete means economically viable.
  • the objective of this solution is the design and manufacture of a gel suitable for the transmission of ultrasonic waves for the purposes of medical, paramedical and / or veterinary procedures, which probe nurse gel opening through at least one orifice close to the window of transmission and / or reception of the signals of the probe to allow an act of ultrasound in one piece, in a continuous and efficient way, respecting all the codes of hygiene and sterile procedure recommended and or desired in the field and from the production of said gel.
  • the invention designs a gel which from its first stage of manufacture to its final stage of the application under examination knows no sanitary breakage by direct contact with the environment of packaging, storage, handling, commissioning on ultrasound machines and in fine distribution on the examination surface.
  • the invention is based on gels whose viscosity whose viscosity is between seventy-five thousand and ninety-five centipoise by implementing said current gels trade in the sanitary state required at their stage of manufacture and or at their optimum conditioning stage of 1000 ml by reformulating said gel under a controlled ambient atmosphere in that said gel is at least made by the combination of at least one gel with natural macromolecules of cellulose type or synthetic carbomer type at least sterile water.
  • the invention also relates to a gel manufacturing method according to that described above. Reformulation of the process by the addition of sterile water combined by gentle and regular mixing under a natural ambient atmosphere produces macromolecular bonds distinct from those of current vacuum processes; the gel remains or becomes a colloidal solution in semi-solid dosage form, but its density has changed without allowing an emulsion and without affecting its other physical characteristics useful for the medical ultrasound imaging act. On the other hand, and in order to obtain a perennial gel for a period of at least two years, it is necessary in the gel manufacturing method according to any one of the preceding claims, to carry out alternating resting and mixing steps of the mixture of said combination.
  • the subject of the invention is also a flexible pouch of ultrasonic gel, typically in accordance with that described above.
  • the gel In the absence of the need for manipulation the gel is conditioned to volumes for the minimum of 500ml, more economical, which abounded by the automatic distribution reduces the useful amount of examination gives an advantage for a volume of 250ml for a number of examinations at least 2 times higher than a classical practice; conversely in the conventional case when 4 250ml flasks were made necessary by the examinations, the invention is two flasks of 250ml for a greater number of examination because the invention allows the consumption of the gel to its last drop .
  • a bottle containing a gel must be uncorked, shaken if it is started, returned to present its nozzle on the examination area, do not touch the examined subject and be capped for reasons of maintaining the sterility of the gel and the gel. 'surgery. Mission almost impossible, because the elastic wall of the bottle pressed to express the gel sucks, if it is not accidentally something else, the gel of the nozzle in contact with the external environment. Existing packaging will never be ideal because of the variety of exam features. The larger the package, the more the gel will take time to align with the ambient temperature. The viscosity and homogeneity characteristics are affected, hence the results also.
  • the bottle interferes with its concentration and the many manipulations temporarily or permanently affect but certainly and surely the integrity of the functions of his hand, or even his "upper member, usually acting and frequently on the bottle.
  • a quantity of gel is deposited in the judgment before setting the window for transmitting and / or receiving the signals on the sheet thus formed, then it is scanned with the probe, which causes pile-ups and unavoidable defilements of the material and the field of examination.
  • multiple interventions simultaneous with that of ultrasound, such as invasive medical procedures the risk of contamination and endangering physical integrity is real.
  • the time factor which by deduction of all the foregoing is crucial for the success of the operation, is undoubtedly increased by the fact of the bottle of gel. It should be noted that the operational and economic profitability of these acts is significantly affected.
  • this solution allows the realization of an act of ultrasound in one piece, in a continuous and efficient manner, respecting all the codes of hygiene and sterile operating procedures recommended and or desired in the field. But the solution is not optimal and requires a trocar while the ideal would be to simplify at best the most functional such pocket.
  • Such a bag is already adapted to an automated use requiring both a balancing between gel outlet pressures of the bag, suction forces by the pump for a constant flow guarantee at each withdrawal of gel.
  • the invention proposes to solve these problems; the solution consists in that the reservoir is a flexible pouch, hermetic and sterile hermetically connected by a tubing or means of supply equivalent to a hermetic and hermetic pump, connected itself hermetically to at least one probe and characterized in that it has a single supply opening and distribution and at least centered to take advantage of the gravitational effect and emptying the pocket without any call compensatory air.
  • the invention takes advantage of the gravity exerted on the gel and the atmospheric pressure exerted on the flexible walls of the pockets to ensure a supply circuit without air and return of gel, thus avoiding any risk of contamination by the direct environment of the pocket.
  • it facilitates the production and implementation of these pockets by allowing both the filling and emptying of the latter in respect of all health considerations and in use.
  • FIG. 1 is a flow chart showing various steps of the gel manufacturing method according to the invention.
  • FIG. 2 schematically represents a pocket according to the invention and according to an embodiment with a sleeve pipe which can be closed with a plug;
  • FIG. 3 schematically shows an echograph with attached to the pocket of FIG. 2.
  • FIG. 4 represents in curve the results achieved by the gel (BCL) according to the invention compared to the gels of the prior art
  • the flexible pouch 1 shown in Figs. has walls 2 constituting its envelope, thin enough to follow any conformation of the gel G during the racking of this last by the pump P supply of gei G to the ultrasonic probe S and under the effect of ambient atmospheric pressure and without altering the suction force of said pump P.
  • the pocket conformation 1 and the flexibility of the walls 2 provide a large area for rapid and significant heat exchange achieving a balancing of the temperature of the gel G with that ambient.
  • said pocket 1 may, if appropriate, be housed in a housing L integral with the pump P and comprising heating devices such as resistors R of the gel G at the ambient comfort temperature.
  • the pocket 1 has at its end opposite the opening 3 of an anchoring or hooking means 4 to allow its positioning at or near the ultrasound system to take advantage of the gravitational effect on the gel BOY WUT.
  • Said opening 3 is shown with an open flexible tubular sleeve 5 with a schematic representation of the sealing means, such as a plug 6 described in the invention, at its orifice.
  • the pocket 1 is removable and replaceable by any other pocket of the same type and capacity adapted to the characteristics of the practiced act and typically calibrated at 250, 500 or 1000 milliliters.
  • the invention ultimately makes it possible to adapt the ideal volume required for series of standard acts.
  • the pocket 1, the pump P and the various tubes G of the gel flow G form a hermetic and sterile circuit with a single opening on the probe S.
  • the peristaltic pump P has no contact with the gel G. No return of gel G is possible, hence no gel return G of the probe S.
  • the invention implements the current gels of G1, G2 trade in the sanitary state required at their stage of manufacture and / or at their optimum 1000 ml packaging stage by reformulation of said gel under controlled ambient atmosphere in that the new reformulated gel G according to the invention is produced by the combination of at least two types of known gel, the first being synthetic macromolecules of the carbomer type and the second being made of natural macromolecules of the cellulose type and at least sterile H2O water.
  • the invention therefore is not required to proceed downstream of the manufacturing process of said commercial gels G1, G2 and can in both cases of realization which proceed to the manufacture directly in sterile ambient atmosphere of said gels (G) reformulated directly from each of the natural or synthetic macromolecules, alone or in combination and in combination with sterile water.
  • the invention realizes the reformulation of said gels or the production of said gels by combination obtained in a controlled natural atmosphere at room temperature, step C.
  • step B The realization of the combination of the gel components and the sterile water is obtained following a smooth and regular mixing, without constraint of eviction of air bubbles, step B.
  • the addition of a certain amount of water Sterile at current known concentrations is already sufficient to obtain a fluidity gel improved by at least twice that of commercial gels.
  • the conditioning and the gravitational outlet of the fluid concentrate the bubbles in the container and or escape from the automated dispensing circuit of the ultrasound system.
  • the invention has designed and manufactured a gel G, making it possible to overcome the problems stated and thus to reap the advantages of a very inexpensive production, capable of being conditioned from the beginning of manufacture to its use in During ultrasound procedures without risk of contamination by any environment including that of sterile air bubbles, thanks to a reformulation making the gel G suitable for automated distribution and further customizable in its formulation to each operator ultrasound.
  • the gel G of the invention is enriched with water stabilized in a natural ambient atmosphere by successive stirring steps B between resting stages Re which advantageously retains it for a longer time because it dries less quickly, slides better and its fluidity in no way encumbers the automatic devices of distribution of the conditioning to the probes S.
  • the practice of the echography not only makes it possible to optimize the currently offered technology, but it optimizes the diagnosis by an improved temporal and spatial medical imagery.
  • the said gel G of the invention does not stick, does not stain and can not flow because of the notorious reduction of the quantities necessary for examination because of the automated distribution on the probe S. Its fluidity also makes it possible to put very quickly at room temperature or, if necessary, withstand rapid heating without losing its consistency and / or properties; all this for a real comfort of the patient.
  • the connection of the bag 1 is made with a tubing 5 or equivalent connecting the bag 1 to a pump P supply ultrasonic probes S.
  • the opening of the pocket abuts the flexible tubing 5 of sufficient length and suitable for supply and the hermetic introduction of a plug 6 after severing at said plug of the end of the feed tube of the nurse.
  • the invention proposes to be as minimalist as possible to keep only what is essential to a practical and sanitary implementation.
  • the solution consists of two embodiments having in a first embodiment the opening 3 which comprises a reinforced ring forming a reinforced peripheral peripheral lip of diameter substantially equal to the external diameter of the filling tips and to the diameter of the ends of the tubing of FIG. supply and in a second mode, the opening comprises a flexible tubing (5) or immovably integral sleeve of said opening, of diameter substantially equal to the outer diameter of the filling tips and the diameter of the ends of the supply tubing 5
  • the invention provides a single opening 3 which abuts, according to the means retained, a reinforced crown or a flexible tubing 5 of sufficient length and both means being dimensionally suitable for the direct connection and without accessories of the introduction and / or extraction means.
  • ultrasonic gel G while allowing means for sealing such openings with hermetic means breakable or perforable and / or the hermetic introduction of a sterile plug 6.
  • the invention provides to provide with all pockets 1 of gel G at least one plug 6 of composition identical to that of the envelope 2 of the bags 1 and this in a sterile package.
  • said plug 6 is dimensionally adapted to be inserted into the mouth of the tubing 5 or the crown of the single opening 3.
  • such a plug 6 can be placed on the tubing 5 of the sleeve after filling the plug. pocket 1 in which case the sonographer will simply cut the tubing sleeve 5 to its height and made the junction.
  • the invention therefore provides a pocket 1, wherein the closure of said tubing is obtained with a plug 6 of neutral synthetic material adhering to the inner wall of said tubing 5; the closure of said pocket 1 is obtained with a plug 6 of material and composition for the least similar and compatible with that of said pocket
  • the pocket 1 contains a cleaning and sterilizing solution adapted at least for the needs of maintenance and hibernation of the circuit. This possibility makes it possible to increase the guarantee of sterile good performance of the ultrasound system and avoids any deposits that may create turbulence or discomfort in the flow of the gel G as a result of hibernation of the devices or a consequent stoppage. or exogenous phenomena, such as, for example, substantial changes in the temperature leading to structural modifications of the gel G.
  • the gel G is permanently and permanently in contact with and wrapped by the flexible membrane 2 of said bag 1.
  • any inconceivable air bubble for quality ultrasound imaging can because of the fluidity of the ultrasonic gel G of the escape and be confined in the upper air part of the pocket2.
  • the gel G according to the invention suitable for the transmission of ultrasonic waves for the purposes of medical, paramedical and / or veterinary procedures, which gel G is produced by minus a G1 gel with natural macromolecules of the cellulose type and at least H2O water, characterized in that said gel G being for probe nipple S opening through at least one orifice near the emission window and / or the signal S is received at least by the combination of at least one gel of macromolecules natural cellulose type or synthetic carbomer type and at least sterile water, production of said reformulated G gels directly in a sterile ambient atmosphere.
  • the Fie. 3 represents 3 represents the three different steps of the method of manufacturing one of the six embodiments of the gel. It has three inputs G1 or G2 in combination with H2O.
  • the agglomerating power of the gel according to the invention is much more stable than that of known gels. These characteristics make it possible to use a flexible circuit for dispensing the gel.
  • a fluid circuit comprising at least one hermetic and sterile flexible bag 1 hermetically connected via a semi-rigid tube T to a pump assembly P hermetically connected via a semi-rigid tube T to at least a part of its length for supplying GT gel the window for transmitting and / or receiving the signals of a probe S of an ultrasound machine as described above makes it possible to automatically clear the operator of the parasitic action of manual gel supply and to protect the remaining gel for subsequent acts of contact with air, the patient or any other sources or factors of contamination. This solution is reached because the tightness is ensured both ways, not only a seal towards the outside of the circuit which avoids the gel leakage out of distribution, but also a seal towards the inside of the circuit which protects the gel from the contacts with the air.
  • the gel (G) is applied following passage through a fluid circuit of an ultrasound system comprising at least the hermetic and sterile flexible pouch 1, hermetically connected via the tube T to the pump assembly P hermetically connected via the tube T for supplying G with the window for transmitting and / or receiving the signals of the probe S.
  • G gel according to the invention G1 gel with natural macromolecules

Abstract

The invention relates to a gel (G) adapted for transmitting ultrasound waves and intended for medical, paramedical and/or veterinary activities, wherein said gel (G) for a probe (S) feedtank is discharged through at least one opening in the vicinity of the window for transmitting and/or receiving signals from the probe (S). Said gel is at least produced by combining at least one gel containing natural cellulose macromolecules (G1) and optionally a second gel which can be synthetic, and at least water. The method for making the gel (G) includes the alternating steps of kneading (B) the mixture of said composition and allowing the mixture of said composition to rest (Re). The flexible, sealed and sterile bag (1) for the ultrasound gel (G) is sealingly connected by a supply means, such as tubes or the like, to a pump (P) that is in turn sealingly connected to at least one probe. The bag (1) has a single and centred supply and dispensing opening (3). The invention also relates to the application of the gel (G) flowing through a fluid circuit of an ultrasonograph including at least the flexible sealed and sterile pouch (1) sealingly connected via the tube to the pump assembly (P) sealingly connected via the tube for supplying gel to the window for transmitting and/or receiving signals from the probe (S).

Description

Ge! approprié à la transmission d'ondes ultrasoniques, procédé de fabrication dudit gel et poche le contenant. Ge! suitable for transmitting ultrasonic waves, method of manufacturing said gel and pouch containing it.
La présente invention concerne la transmission d'ondes ultrasoniques aux fins d'actes médicaux, paramédicaux et/ou vétérinaires.The present invention relates to the transmission of ultrasonic waves for medical, paramedical and / or veterinary purposes.
En premier lieu, l'invention se rapporte à un gel approprié à la transmission d'ondes ultrasoniques, lequel gel pour nourrice de sonde débouchant par au moins un orifice à proximité de la fenêtre d'émission et/ou de réception des signaux d'une sonde uitrasonique dite à effet DOPPLER et pour laquelle une interface du type gel adapté à la transmission d'ondes ultrasoniques est un besoin inaliénable pour pouvoir être opérationnel. Ces gels qui se présentent en solutions colloïdales sous forme galénique semi-solide sont essentiels non seulement à l'obtention d'une image mais encore à la qualité de cette dernière comme il apparaîtra dans la description qui suit pour situer ledit gel dans l'art de l'imagerie médicale par échographie.In the first place, the invention relates to a gel suitable for the transmission of ultrasonic waves, which probe nurse gel opening through at least one orifice near the transmission window and / or reception of the signals of a uitrasonique probe called DOPPLER effect and for which a gel-type interface adapted to the transmission of ultrasonic waves is an inalienable need to be operational. These gels, which are in colloidal solutions in semi-solid galenic form, are essential not only for obtaining an image but also for the quality of the latter, as will be apparent from the following description for locating said gel in the art. medical imaging by ultrasound.
Le gel selon l'invention en usage en échographie. Il a été évoqué en tant que contenu dans son contenant dans la demande de brevet enregistrée sous le N0 08/00475.The gel according to the invention used in ultrasound. It was mentioned as contained in its container in the registered patent application under No. 0 08/00475.
Un échographe est constitué d'une sonde permettant l'émission et la réception d'ultrasons, d'un système informatique exploitant le délai entre la réception et l'émission de l'ultrason en image, d'une console de commande aux fins de différents réglages, d'un moniteur, d'un, système d'enregistrement analogique et ou numérique des données, le tout disposé sur un support mobile permettant d'effectuer l'examen échographique en toutes circonstances attrayant au patient.An ultrasound system consists of a probe allowing the emission and reception of ultrasound, a computer system exploiting the delay between the reception and the emission of the ultrasound image, a control console for the purpose of various settings, a monitor, an analog recording system and or digital data, all arranged on a mobile support to perform ultrasound examination in all circumstances attractive to the patient.
L'élément de base de l'échographie est un ensemble transducteur ultrasonore, une céramique piézoélectrique située dans la sonde et émettant des ultrasons dont les échos sont réceptionnés en mode fondamental ou harmonique, en mode linéaire ou non, par cette même céramique. Les sondes, de forme convexe ou de forme linéaire ou encore de forme micro convexe, partant les transducteurs ultrasonores varient selon l'organe étudié et ou selon une définition ciblée d'une image spatiale mais aussi temporelle. Une sonde échographique moderne possède aujourd'hui jusqu'à 960 éléments pour des imageries médicales classiques, mais elle atteint aisément les 3000 éléments en cardiologie. Les prochaines générations de sonde auront plus de 12000 éléments piézoélectriques avec une émission successive sur chaque transducteur.The basic element of ultrasound is an ultrasonic transducer assembly, a piezoelectric ceramic located in the probe and emitting ultrasound whose echoes are received in fundamental or harmonic mode, in linear mode or not, by this same ceramic. The probes, of convex shape or of linear form or of micro convex shape, and hence the ultrasonic transducers vary according to the organ studied and or according to a targeted definition of a spatial but also temporal image. A modern ultrasound probe now has up to 960 elements for conventional medical imaging, but easily reaches 3000 elements in cardiology. The next generations of probes will have more than 12000 piezoelectric elements with a successive emission on each transducer.
La fréquence des ultrasons est un élément très important : modulée elle permet d'avoir un signal plus précis et influer la qualité d'une image et ceci explique la disponibilité de plusieurs sondes, pour des fréquences s'adaptant en usage courant, pour le secteur profond avec une définition de l'ordre de quelques millimètres ; pour les structures intermédiaires avec une résolution inférieure au millimètre ; pour l'exploration des petites structures assez proches de la peau avec une résolution proche du dixième de millimètre ; et les fréquences supérieures à 10 Mhz pour l'imagerie superficielle.The frequency of ultrasound is a very important element: modulated it allows to have a more precise signal and affect the quality of an image and this explains the availability of several probes, for frequencies adapting in current use, for the sector deep with a definition of the order of a few millimeters; for intermediate structures with a resolution less than one millimeter; for the exploration of small structures close to the skin with a resolution close to a tenth of a millimeter; and frequencies above 10 MHz for superficial imaging.
L'élément incontournable pour pratiquer l'échographie est le gel dit ultrasonique. En effet et pour des raisons mécaniques, on considère que le contact entre la sonde et la peau du patient ne peut pas être parfait et qu'il existe donc une fine couche d'air entre la sonde et le ventre. Il est alors question d'impédances acoustiques de l'air et de la peau, en Pa. s/m dont les valeurs permettent de calculer la valeur du coefficient de transmission de l'interface air-peau. Cette valeur est très faible et engendre donc une atténuation importante du signal entre l'émission et la réception des ultrasons par la sonde. Aussi l'échographie est-elle tenue de passer avec une interface telle qu'un gel, dont l'impédance acoustique est proche de celle de la peau (T≈10-3), pour augmenter la qualité du signal entre l'émission et la réception des ultrasons. Il convient de noter que l'air est un facteur perturbateur ; aussi toute production de gel se fait en prenant soin de ne pas contaminer le gel, lors de sa fabrication et lors du conditionnement du gel, avec des bulles d'air qui seraient irrémédiablement emprisonnées dans le gel du fait de sa viscosité.The essential element for practicing ultrasound is the so-called ultrasonic gel. Indeed and for mechanical reasons, it is considered that the contact between the probe and the skin of the patient can not be perfect and that there is therefore a thin layer of air between the probe and the belly. It is then question of acoustic impedances of the air and the skin, in Pa. S / m whose values make it possible to calculate the value of the transmission coefficient of the air-skin interface. This value is very low and therefore generates a significant attenuation of the signal between the emission and the reception of the ultrasound by the probe. Ultrasound is therefore required to pass with an interface such as a gel, whose acoustic impedance is close to that of the skin (T≈10-3), to increase the quality of the signal between the emission and the reception of ultrasounds. It should be noted that air is a disruptive factor; also any gel production is done taking care not to contaminate the gel, during its manufacture and during the conditioning of the gel, with air bubbles that would be irremediably trapped in the gel because of its viscosity.
- II existe des échographes correspondant à la description qui précède et à dispositif distributeur de gel rapporté ou intégré à au moins une sonde émettrice et ou réceptrice de signaux, comprenant un réservoir de gel approprié à la transmission d'ondes ultrasoniques aux fins d'actes médicaux, paramédicaux et/ou vétérinaires. Lequel gel provient du réservoir solidaire de la sonde et débouche par au moins un orifice à proximité de la fenêtre d'émission et ou de réception des signaux de la sonde émettrice et/ou réceptrice desdits signaux. Dans la demande de brevet enregistrée sous le N° 08/00475 il est indiqué qu'un opérateur droitier manipule simultanément la sonde de sa main droite et actionne les commandes des périphériques et les touches du clavier de sa main gauche. La performance et la qualité du résultat sont directement fonction de la synchronisation de ces actions. Ceci pour indiquer que le résultat d'un acte d'échographie, partant la qualité spatiale et temporelle en imagerie ultrasonique dépend non seulement de la haute technicité de l'échographe mais encore de l'opérateur échographe et des caractéristiques du gel employé.There are ultrasound scanners corresponding to the foregoing description and to a gel dispensing device attached to or integrated with at least one transmitting and / or receiving signal probe, comprising a gel reservoir suitable for transmitting ultrasonic waves for acts medical, paramedical and / or veterinary services. Which gel comes from the reservoir integral with the probe and opens through at least one orifice near the window for transmitting and / or receiving signals from the emitter and / or receiver probe of said signals. In the patent application registered under No. 08/00475 it is stated that a right-handed operator simultaneously manipulates the probe of his right hand and actuates the commands of the peripherals and the keys of the keyboard of his left hand. The performance and the quality of the result are directly a function of the synchronization of these actions. This is to indicate that the result of an ultrasound act, hence the spatial and temporal quality in ultrasound imaging, depends not only on the high technicality of the ultrasound system but also on the ultrasound system operator and the characteristics of the gel used.
De cet état de la technique connu dans la demande de brevet enregistrée sous le N° 08/00475, on retiendra que les problèmes posés par l'art antérieur, sans les répéter dans la présente demande de brevet, demeurent à l'instant de la présente invention. Il est à noter déjà qu'aucun gel du commerce ne convient en aucune manière à une utilisation d'un dispositif d'approvisionnement mécanique ou électromécanique du gel et tel que revendiqué dans la demande.From this state of the art known in the patent application registered under No. 08/00475, it will be remembered that the problems posed by the prior art, without repeating them in the present patent application, remain at the instant of the present invention. It should be noted already that no commercial gel is in any way suitable for use of a device for mechanical or electromechanical supply of the gel and as claimed in the application.
Pour répondre avec des interfaces innovantes, l'art antérieur propose entre autres l'abandon du gel classique ainsi qu'un gain de temps avec un dispositif comportant un produit fluide qui est versé sur une compresse non tissée, laquelle est préalablement appliquée sur la région à échographier, laissant un film ayant la propriété de permettre la transmission des ultrasons. Ce film disparaît spontanément en quelques minutes, sans nettoyage nécessaire. L'utilisation principale de l'invention recouvre l'échographie médicale pour tout utilisateur souhaitant ne plus utiliser le gel classique. Mais à l'usage la mise en œuvre du dispositif s'est avérée plus complexe dans son utilisation ;In order to respond with innovative interfaces, the prior art proposes among other things the abandonment of conventional freezing as well as a saving of time with a device comprising a fluid product which is poured onto a nonwoven compress, which is previously applied to the region. to ultrasound, leaving a film having the property of allowing the transmission of ultrasound. This film disappears spontaneously in a few minutes, without necessary cleaning. The main use of the invention covers medical ultrasound for any user wishing to no longer use the conventional gel. But in use the implementation of the device has proved more complex in its use;
Aussi l'échographiste dispose-t-il toujours de deux catégories de gel sur le marché des consommables médicaux et pharmaceutiques ; il faut distinguer les gels composés de macromolécules naturelles de la famille des celluloses des gels composés de macromolécules synthétiques de la famille des carbomères. La base des compositions de tels gels en solutions colloïdales sous forme galénique semi-solide reste identique s'agissant en effet du mélange d'une base macromoléculaire et d'un conservateur pour le moins et pour le plus additionné avec des adjuvants thérapeutiques, parfumant ou colorant ou autres de confort et ou de soins.The sonographer therefore still has two categories of gel in the market for medical and pharmaceutical consumables; it is necessary to distinguish the gels composed of natural macromolecules of the family of celluloses gels composed of synthetic macromolecules of the family of carbomers. The base of the compositions of such gels in colloidal solutions in semi-solid galenic form remains identical, since it is indeed a mixture of a macromolecular base and a preservative for the least and for the most added with therapeutic adjuvants, perfuming or dye or other of comfort and or care.
Cela est une authentique limitation de la technique qui focalise le problème posé sur le gel car il affecte tout autant que les problèmes posés déjà par ailleurs l'examen à tous niveaux le matériel, l'utilisation, le mode opératoire, le patient, l'environnement et l'espace, l'aspect économique in fine comme suit ci-après.This is a genuine limitation of the technique which focuses the problem posed on the gel because it affects just as much as the problems posed already elsewhere the examination to all levels the material, the use, the operating mode, the patient, the environment and the space, the economic aspect in fine as follows hereafter.
Il faudra retenir que la loi pour des raisons sanitaires manipulations obligeant, fixe des conditionnements standards de 250 millilitres à usage unique ou réutilisable pour la pratique, de 500 ou 1000 millilitres pour permettre des remplissages de contenant adaptés aux caractéristiques et fréquences des examens pratiqués. De façon approximative, 250 ml suffisent pour vingt examens et/ou une journée de pratique. Pour des règles sanitaires et de performance du gel, il n'est pas conseillé de conserver un flacon entamé et/ou souillé par Ie contact de son embout avec la paroi de l'organisme examiné, tout comme de procéder à des remplissages de flacon hors enceintes stériles. Toutefois, des contenants de cinq litres sont couramment utilisés à cet effet de remplissage par les opérateurs. Il en résulte de ce qui précède que l'opérateur fait face à des contraintes multiples et imposées tant pour l'obtention d'une qualité d'informations nécessaire à un examen performant et de qualité, que pour la performance de son outil et que pour la rentabilité et l'urgence des examens. En effet, c'est directement de et proportionnellement à l'homogénéité et à la régularité de la couche de gel disposée entre la fenêtre d'émission et/ou de réception des signaux et la paroi externe de l'organisme observé, que dépendent les résultats et l'optimisation de leurs caractéristiques.It should be remembered that the law for sanitary reasons obligatory maneuvers, sets standard packages of 250 milliliters for single use or reusable for practice, 500 or 1000 milliliters to allow container refills adapted to the characteristics and frequencies of the examinations practiced. Approximately 250 ml is enough for twenty exams and / or one day of practice. For sanitary rules and performance of the gel, it is not advisable to keep a bottle opened and / or contaminated by the contact of its tip with the wall of the organism examined, as well as to carry out bottle filling out sterile pregnant. However, five-liter containers are commonly used for this purpose of filling by the operators. As a result of the foregoing, the operator faces multiple and imposed constraints both in terms of obtaining the quality of information necessary for an efficient and quality examination, as well as for the performance of his tool and for the profitability and the urgency of the examinations. Indeed, it is directly from and proportionally to the homogeneity and regularity of the gel layer disposed between the emission window and / or the reception of the signals and the external wall of the observed organism, that the results and the optimization of their characteristics.
En effet de ce qui précède il découle que les gels du commerce et eu égard à la technicité croissante des échographes ne peuvent plus satisfaire les exigences d'une imagerie spatiale et temporelle de haute précision; avec la technologie annoncée cela devient encore moins concevable.From the foregoing, it follows that commercial freezes and the growing technicality of ultrasound scanners can no longer satisfy the requirements of high precision spatial and temporal imagery; with the announced technology it becomes even less conceivable.
Les moyens d'applications du gel n'ayant pas changé ; le gel conserve les mêmes conditionnements et ceci n'est pas fait pour améliorer sa fluidité et sa viscosité une fois appliquée. Souvent il sèche trop vite et il est impensable d'y adjoindre plus d'eau sans ie rendre impropre à sa destination. En séchant il glisse moins et affecte la durée de l'examen, partant l'image qu'il faut reprendre avec une nouvelle application jusqu' à pouvoir assurer le diagnostic sans doutes aucuns sur les observations visuelles effectuées.The means of application of the gel having not changed; the gel retains the same packaging and this is not done to improve its fluidity and viscosity once applied. Often it dries too quickly and it is unthinkable to add more water without making it unsuitable for its purpose. By drying it slips less and affects the duration of the examination, leaving the image to be taken again with a new application until it can ensure the diagnosis without doubts about the visual observations made.
Même avec des adjuvants de confort i! ne peut varier sa viscosité. Celle- ci peut avoir des conséquences désagréables pour son utilisateur comme pour celui qui le subit ; il peut tacher, donner des sensations de froid, voire donner lieu à verser des quantités inadaptées importantes ; En effet il faut du temps pour lui faire prendre la température ambiante et ne pas être en rupture de stock dans le cabinet sinon ce sera du gel à température du stock qu'il faudra utiliser. Même conditionné en contenant plastique les pressions ou secousses ne permettent pas toujours un dosage idoine pour chaque application et il vaut mieux s'assurer de la réussite de l'examen en mettant plutôt trop que pas assez et reprendre. La viscosité ne permet pas de vider un flacon que trop souvent est jeté avec un reliquat non négligeable de gel. C'est une perte économique et écologique.Even with comfort adjuvants i! can not vary its viscosity. This can have unpleasant consequences for both the user and the user. undergone; it can stain, give feelings of cold, even give place to pay large unsuitable quantities; Indeed it takes time to make him take the room temperature and not be out of stock in the cabinet otherwise it will be freezing temperature of the stock it will use. Even packaged in plastic container the pressures or jerks do not always allow a proper dosage for each application and it is better to ensure the success of the test by putting rather too much that not enough and resume. The viscosity does not allow to empty a bottle that too often is thrown away with a significant remainder of gel. It is an economic and ecological loss.
La viscosité implique nécessairement une manipulation et dans ces conditions répétitives et perpétuelles pour chaque examen ; cela ne va pas sans affecter l'état de santé des opérateurs qui voient apparaître des tendinites et in fine des affections professionnelles rédhibitoires pour la pratique de l'examen d'échographie.Viscosity necessarily implies manipulation and in these repetitive and perpetual conditions for each examination; this does not go without affecting the state of health of the operators who see tendinitis and ultimately occupational diseases crippling the practice of ultrasound examination.
La contrainte sanitaire n'est pas neutre. Dans des cas de contamination un dépistage microbiologique extensif en milieu hospitalier avait révélé une contamination par Burkholderia cepacia dans un gel pour échographie. Le gel pour échographie était un produit commercial disponible en contenants de 260 et de 1000 ml. Le fabricant a été informé de la contamination. En effet il existe des publications spécialisées internationales qui décrivent la contamination par Burkholderia cepacia déjà pendant la production. Rien que cet exemple montre que la fabrication elle-même du gel à des viscosités aptes à, la production d'examens d'échographie pertinents en respectant tous les paramètres techniques et légaux, entraînent des procédés de fabrication onéreux. Pour satisfaire la demande actuelle les fabricants produisent sous vide en atmosphère contrôlées et partant pour des raisons économiques en des quantités minimales de l'ordre de 1000 litres. Il devient évident que toutes ces précautions demeurent vaines du fait même de la rupture de la sûreté sanitaire dés l'ouverture d'un contenant, voire dés un premier contact du patient avec contenant /contenu, voire encore du fait de la dépose entre deux manipulations contenant non rebouché etc..The health constraint is not neutral. In cases of contamination, extensive microbiological screening in a hospital setting revealed contamination of Burkholderia cepacia in an ultrasound gel. The ultrasound gel was a commercial product available in containers of 260 and 1000 ml. The manufacturer has been informed of the contamination. Indeed, there are international specialist publications describing Burkholderia cepacia contamination already during production. Only this example shows that the manufacture of the gel itself at viscosities suitable for the production of relevant ultrasound examinations respecting all the technical and legal parameters, lead to expensive manufacturing processes. To meet the current demand manufacturers produce under vacuum in controlled atmosphere and for economic reasons in minimal quantities of the order of 1000 liters. It becomes obvious that all these precautions remain unfulfilled by the very fact of the rupture of sanitary safety from the opening of a container, or even from a first contact of the patient with container / content, or even because of the removal between two manipulations uncapped container etc ..
D'autres facteurs comme la sensibilité température ambiante affectent le gel et le rendent encore inutilisable ou désagréable pour le patient et l'opérateur. Encore le facteur air étant perturbateur il faut veiller à ne pas provoquer une émulsion lors de la manipulation du contenant et de l'application du gel. Seul un gel visqueux et peu fluide permet d'éviter ces inconvénients.Other factors such as ambient temperature sensitivity affect the gel and make it still unusable or uncomfortable for the patient and the operator. Again the air factor being disruptive care must be taken not to cause an emulsion during the handling of the container and the application of the gel. Only a viscous gel and little fluid avoids these disadvantages.
Il en est un autre qui concerne l'opérateur qui doit s'adapter à la technologie proposée en matière d'imagerie échographiques, sans qu'il soit possible de proposer au praticien d'adapter la technique opératoire à ses propres rythmes. En effet chaque opérateur à ses réflexes et rythmes propres selon ses propres caractéristiques physiques et sensorielles pour le moins. Plus rapide un gel moins fluide ferait mieux son affaire, et inversement un gel plus fluide permettrait d'affiner l'examen selon circonstances etc.... Mais en l'état actuel de la technique ceci n'est pas envisageable.Another is the operator who must adapt to the proposed technology in ultrasound imaging, without it being possible to propose to the practitioner to adapt the surgical technique to its own rhythms. Indeed, each operator has his own reflexes and rhythms according to his own physical and sensory characteristics for the least. Faster a less fluid gel would do better, and conversely a gel more fluid would refine the examination according circumstances etc .... But in the current state of the art this is not possible.
Ainsi, le gel le plus proche de l'invention connu dans l'état de la technique est enseigné par le document WO 2007/038855A. Ce document dit D1 décrit un gel approprié à la transmission d'ondes ultrasoniques aux fins d'actes médicaux, paramédicaux et/ou vétérinaires, lequel gel étant réalisé par au moins un gel à macromolécules naturelles du type cellulose et au moins de l'eau (H2O), ce gel est utilisé en flacon car il ne peut être utilisé dans une poche et par conséquent exige de maintenir le patient en ambiance stérile et que le gel se stérilise par lui- même.Thus, the closest gel of the invention known in the state of the art is taught by the document WO 2007/038855A. This document D1 describes a gel suitable for the transmission of ultrasonic waves for the purposes of medical, paramedical and / or veterinary procedures, which gel is produced by at least one gel with natural macromolecules of the cellulose type and at least water (H 2 O), this gel is used in a vial because it can not be used in a pocket and therefore requires maintaining the patient in a sterile environment and the gel is sterilized by itself.
Au contraire, le gel de l'invention est pour nourrice de sonde débouchant par au moins un orifice à proximité de la fenêtre d'émission et/ou de réception des signaux de la sonde. Ce gel est au moins réalisé par la combinaison d'au moins un gel étant à macromolécules naturelles du type cellulose ou synthétiques de type carbomère au moins de l'eau stérile, réalisation directement en atmosphère ambiante stérile desdits gels reformulés directement à partir de chacune des macromolécules naturelles ou synthétiques, seules ou combinée et en combinaison avec de l'eau stérile, ledit gel étant ensuite isolé dans une poche souple à usage unique, partie intégrante d'un circuit fermé pour permettre un acte d'échographie en un seul tenant, de façon continue et performante, en respectant tous les codes d'hygiène et de mode opératoire stérile préconisés et ou souhaités en la matière et ce dès la production dudit gelOn the contrary, the gel of the invention is for probe nurse opening through at least one orifice near the window of transmission and / or reception of the signals of the probe. This gel is at least achieved by the combination of at least one gel being with natural macromolecules of the cellulose type or synthetic carbomer type at least sterile water, production directly in sterile ambient atmosphere of said reformulated gels directly from each of the natural or synthetic macromolecules, alone or combined and in combination with sterile water, said gel being then isolated in a disposable flexible pouch, part of a closed circuit to allow a one-piece ultrasound act, continuously and efficiently, respecting all the codes of hygiene and sterile operating procedures recommended and or desired in the field and from the production of said gel
Aussi, ledit gel fabriqué en circuit fermé stérile de l'invention n'est pas anticipé par ce document.Also, said sterile closed circuit gel of the invention is not anticipated by this document.
Par contraste avec les gels connus, le gel de l'invention étant lui-même enfermé dans une nourrice stérile, il n'est plus nécessaire que le patient soit en ambiance stérile. Les gels selon l'invention diffèrent de ceux connus par D1 , car ils ont pour fonction de respecter tous les codes d'hygiène.In contrast to the known gels, the gel of the invention being itself enclosed in a sterile nurse, it is no longer necessary for the patient to be in a sterile environment. The gels according to the invention differ from those known by D1, because their function is to comply with all hygiene codes.
De plus, pourquoi combiner ce gel pour flacons à des nourrices de volume et de technologie tout à fait différents ?In addition, why combine this gel for bottles with nurses of volume and technology quite different?
Bien au contraire, ce document concerne des gels antiseptiques (voir page 6 ligne 4).On the contrary, this document concerns antiseptic gels (see page 6 line 4).
Le document FR A 2 770 402 décrit également un gel réalisé pour des flacons. Ii correspond à celui du document WO 2007/038855 A1 en comprenant en plus des étapes de brassage et de repos.The document FR A 2,770,402 also describes a gel made for bottles. Ii corresponds to that of document WO 2007/038855 A1, further comprising stirring and resting steps.
Par conséquent, ce gel de l'état de la technique n'anticipe pas plus l'invention que le précédent pour les mêmes raisons. Le problème de respecter les codes d'hygiène par une poche unique partie intégrante d'un circuit fermé ne peut se faire par ce dispositif.Therefore, this gel of the state of the art does not anticipate the invention more than the previous for the same reasons. The problem of respecting the hygiene codes by a single pocket integral part of a closed circuit can not be done by this device.
Ainsi, l'invention au contraire de l'état de la technique résout le problème permettre un acte d'échographie d'un seul tenant, sans contact du gel avec l'air ambiant avant la peau.Thus, the invention contrary to the state of the art solves the problem allow an act of ultrasound in one piece, without contact of the gel with the ambient air before the skin.
Des dispositifs distributeurs de gel de l'état de la technique sont décrit par les documents US 4 844 080 - FR 2 627 977 - US 2007/194045 et WO 2007/051261.Gel dispensing devices of the state of the art are described by the documents US 4,844,080 - FR 2 627 977 - US 2007/194045 and WO 2007/051261.
Aucun de ces documents ne décrit le dispositif selon l'invention. Ne figurent pas les caractéristiques essentielles permettant d'atteindre l'objet de l'invention, à savoir pas de poche hermétique et stérile, pas de souplesse de poche correspondant aux caractéristiques du gel qui permette à la paroi de rester au contact du gel et pas de connexions souples hermétiques, sans parler des caractéristiques du gel totalement absentes.None of these documents describes the device according to the invention. The essential characteristics which make it possible to achieve the object of the invention are not to mention the fact that there is no hermetic and sterile pouch, no pocket flexibility corresponding to the characteristics of the gel which allows the wall to remain in contact with the gel and not flexible connections hermetic, not to mention the characteristics of the gel completely absent.
Ainsi, l'invention telle que nouvellement revendiquée en 1 résout le problème permettre un acte d'échographie d'un seul tenant, sans contact du gel avec l'air ambiant avant la peau.Thus, the invention as newly claimed in 1 solves the problem allowing an ultrasound act in one piece, without contact of the gel with the ambient air before the skin.
Par conséquent, ces documents de l'état de la technique, même pris en combinaison n'arrivent pas à résoudre le problème technique pour arriver à la solution atteinte par l'invention.Therefore, these documents of the state of the art, even taken in combination do not solve the technical problem to arrive at the solution reached by the invention.
L'invention a pour objectif de prendre en considération et intégralement tous ces aspects et problèmes et d'y répondre avec une solution globale et unique avec des moyens concrets économiquement viables. Avantageusement l'objectif de cette solution est la conception et la fabrication d'un gel approprié à la transmission d'ondes ultrasoniques aux fins d'actes médicaux, paramédicaux et/ou vétérinaires, lequel gel pour nourrice de sonde débouchant par au moins un orifice à proximité de la fenêtre d'émission et/ou de réception des signaux de la sonde pour permettre un acte d'échographie en un seul tenant, de façon continue et performante, en respectant tous les codes d'hygiène et de mode opératoire stérile préconisés et ou souhaités en la matière et ce dès la production dudit gel.The invention aims to take into consideration and fully all these aspects and problems and to respond with a single global solution with concrete means economically viable. Advantageously, the objective of this solution is the design and manufacture of a gel suitable for the transmission of ultrasonic waves for the purposes of medical, paramedical and / or veterinary procedures, which probe nurse gel opening through at least one orifice close to the window of transmission and / or reception of the signals of the probe to allow an act of ultrasound in one piece, in a continuous and efficient way, respecting all the codes of hygiene and sterile procedure recommended and or desired in the field and from the production of said gel.
A cet effet l'invention conçoit un gel lequel de son premier stade de fabrication à son ultime stade de l'application en cours d'examen ne connaît aucune rupture sanitaire par contact direct avec l'environnement de conditionnement, de stockage, de manipulation, de mise en service sur des appareils d'échographies et in fine de distribution sur la surface d'examen.For this purpose the invention designs a gel which from its first stage of manufacture to its final stage of the application under examination knows no sanitary breakage by direct contact with the environment of packaging, storage, handling, commissioning on ultrasound machines and in fine distribution on the examination surface.
L'invention se base sur des gels dont la viscosité dont la viscosité est comprise entre soixante-quinze-mille et quatre-vingt-quinze-milles centipoises en mettant en œuvre iesdits gels actuels du commerce en l'état sanitaire requis à leur stade de fabrication et ou à leur stade de conditionnement optimum de 1000 ml en procédant à une reformulation dudit gel sous atmosphère ambiante contrôlée en ce que ledit gel est au moins réalisé par la combinaison d'au moins un gel à étant à macromolécules naturelles du type cellulose ou synthétiques de type carbomère au moins de l'eau stérile.The invention is based on gels whose viscosity whose viscosity is between seventy-five thousand and ninety-five centipoise by implementing said current gels trade in the sanitary state required at their stage of manufacture and or at their optimum conditioning stage of 1000 ml by reformulating said gel under a controlled ambient atmosphere in that said gel is at least made by the combination of at least one gel with natural macromolecules of cellulose type or synthetic carbomer type at least sterile water.
L'invention a également pour objet un procédé de fabrication de gel conforme à celui décrit ci-dessus. La reformulation du procédé par addition d'eau stérile combinée par brassage doux et régulier sous atmosphère ambiante naturelle produit des liaisons macromoléculaires distinctes de celles des processus actuels sous vide ; le gel demeure ou devient une solution colloïdale sous forme galénique semi-solide, mais sa densité a changé sans permettre une émulsion et sans affecter ses autres caractéristiques physiques utiles à l'acte d'imagerie médicales par ultrasons . Par contre et pour obtenir un gel pérenne pour une période d'au moins deux ans, il faut dans le procédé de fabrication de gel conforme à l'une quelconque des revendications précédentes procédé à des étapes alternées de brassages t de repos du mélange de ladite combinaison. L'invention a également pour objet une poche souple de gel ultrasonique typiquement conforme à celui décrit ci-dessus.The invention also relates to a gel manufacturing method according to that described above. Reformulation of the process by the addition of sterile water combined by gentle and regular mixing under a natural ambient atmosphere produces macromolecular bonds distinct from those of current vacuum processes; the gel remains or becomes a colloidal solution in semi-solid dosage form, but its density has changed without allowing an emulsion and without affecting its other physical characteristics useful for the medical ultrasound imaging act. On the other hand, and in order to obtain a perennial gel for a period of at least two years, it is necessary in the gel manufacturing method according to any one of the preceding claims, to carry out alternating resting and mixing steps of the mixture of said combination. The subject of the invention is also a flexible pouch of ultrasonic gel, typically in accordance with that described above.
En l'absence du besoin de manipulation le gel est conditionné à des volumes pour le minimum de 500ml, plus économiques, ce qui abondé par la distribution automatique réduit la quantité utile d'examen donne un avantage pour un volume de 250ml pour un nombre d'examens au moins 2 fois supérieur à une pratique classique ; inversement dans le cas classique quand 4 flacons de 250ml ont été rendus nécessaires par les examens , l'invention en est à deux flacons de 250ml pour un nombre supérieurs d'examen car l'invention permet la consommation du gel jusqu'à sa dernière goutte.In the absence of the need for manipulation the gel is conditioned to volumes for the minimum of 500ml, more economical, which abounded by the automatic distribution reduces the useful amount of examination gives an advantage for a volume of 250ml for a number of examinations at least 2 times higher than a classical practice; conversely in the conventional case when 4 250ml flasks were made necessary by the examinations, the invention is two flasks of 250ml for a greater number of examination because the invention allows the consumption of the gel to its last drop .
La stabilité du gel que lui confèrent Ia formulation et le procédé permettent une utilisation sans influence notoire des variations de température saisonnières même marquées. D'autres avantages sont formulés dans ce qui suit et l'invention n'est ni tenue voire limitée à ces seuls avantages.The stability of the gel given to it by the formulation and the process allows a use without known influence of the seasonal variations of temperature even marked. Other advantages are formulated in the following and the invention is not held or even limited to these advantages alone.
L'art antérieur et comme indiqué dans la demande de brevet enregistrée sous le N° 08/00475 le problème posé par l'état de la technique s'illustre par et se focalise autant et en combinaison avec ceux du gel, sur le conditionnement du gel.The prior art and as indicated in the patent application registered under No. 08/00475 the problem posed by the state of the art is illustrated by and focuses as much and in combination with those of the gel, on the packaging of the gel.
Un flacon contenant un gel doit être débouché, secoué s'il est entamé, retourné pour présenter sa buse sur la zone d'examen, ne pas toucher le sujet examiné et être rebouché pour des raisons de maintien de la stérilité du gel et de l'opération. Mission quasi impossible, car la paroi élastique du flacon pressée pour exprimer le gel aspire, si ce n'est pas accidentellement autre chose, le gel de la buse en contact avec l'environnement extérieur. Un conditionnement tel qu'existant ne sera jamais idéal du fait même de la variété des caractéristiques des examens. Plus le conditionnement est volumineux plus le gel mettra du temps à s'aligner sur la température ambiante. Les caractéristiques de viscosité et d'homogénéité sont affectées, partant les résultats également.A bottle containing a gel must be uncorked, shaken if it is started, returned to present its nozzle on the examination area, do not touch the examined subject and be capped for reasons of maintaining the sterility of the gel and the gel. 'surgery. Mission almost impossible, because the elastic wall of the bottle pressed to express the gel sucks, if it is not accidentally something else, the gel of the nozzle in contact with the external environment. Existing packaging will never be ideal because of the variety of exam features. The larger the package, the more the gel will take time to align with the ambient temperature. The viscosity and homogeneity characteristics are affected, hence the results also.
Sur le plan de l'opérateur, le flacon interfère sur sa concentration et les nombreuses manipulations affectent temporairement ou durablement mais certainement et sûrement l'intégrité des fonctions de sa main, voire de son membre "supérieur, agissant habituellement et fréquemment sur le flacon. Sur le plan opératoire, une quantité de gel est déposée au jugé avant de poser la fenêtre d'émission et/ou de réception des signaux sur la nappe ainsi constituée, puis ensuite elle est balayée avec la sonde, ce qui provoque des amoncellements et des souillures inévitables du matériel et du champ d'examen. En cas d'intervention multiples et simultanées à celui de l'échographie, telles que des actes médicaux invasifs, le risque de contamination et de mise en danger de l'intégrité physique est réel. Le facteur temps qui par déduction de tout ce qui précède est capital pour le succès de l'opération, est incontestablement augmenté par le fait du flacon de gel. Il faut noter que la rentabilité opérationnelle et économique de ces actes est affectée de manière significative.In terms of the operator, the bottle interferes with its concentration and the many manipulations temporarily or permanently affect but certainly and surely the integrity of the functions of his hand, or even his "upper member, usually acting and frequently on the bottle. Operationally, a quantity of gel is deposited in the judgment before setting the window for transmitting and / or receiving the signals on the sheet thus formed, then it is scanned with the probe, which causes pile-ups and unavoidable defilements of the material and the field of examination. In the case of multiple interventions simultaneous with that of ultrasound, such as invasive medical procedures, the risk of contamination and endangering physical integrity is real. The time factor which by deduction of all the foregoing is crucial for the success of the operation, is undoubtedly increased by the fact of the bottle of gel. It should be noted that the operational and economic profitability of these acts is significantly affected.
Sur le plan du patient et outre le fait du risque de contamination et/ou de mise en danger de son intégrité physique, il y a son confort qui se trouve gêné par la température du gel et fait frissonner ce dernier, ce qui pour certains actes pollue le résultat ou fait faire d'inutiles répétitions.In terms of the patient and in addition to the fact of the risk of contamination and / or endangering his physical integrity, there is his comfort which is hampered by the temperature of the frost and makes him shudder, which for some acts pollutes the result or makes useless repetitions.
Enfin, sur le plan environnemental et plus particulièrement quant à la stérilisation imposée pour certains actes médicaux ou examens de laboratoire, et comme observé dans ce qui précède, le conditionnement actuel ne saurait satisfaire ces exigences.Finally, in terms of the environment and more particularly the sterilization imposed for certain medical procedures or laboratory tests, and as observed in the foregoing, the current packaging can not meet these requirements.
L'invention dans la demande de brevet enregistrée sous le N° 08/00475 a tenté d'y répondre avec une solution globale et unique avec des moyens concrets économiquement viables.The invention in the patent application registered under No. 08/00475 has attempted to respond to it with a global and unique solution with concrete means economically viable.
Avantageusement cette solution permet la réalisation d'un acte d'échographie en un seul tenant, de façon continue et performante, en respectant tous les codes d'hygiène et de mode opératoire stérile préconisés et ou souhaités en la matière. Mais la solution n'est pas optimale et nécessite un trocart alors que l'idéal serait de simplifier au mieux le plus fonctionnel une telle poche.Advantageously, this solution allows the realization of an act of ultrasound in one piece, in a continuous and efficient manner, respecting all the codes of hygiene and sterile operating procedures recommended and or desired in the field. But the solution is not optimal and requires a trocar while the ideal would be to simplify at best the most functional such pocket.
Une telle poche est déjà adaptée à une utilisation automatisée requérant à la fois un équilibrage entre des pressions de sortie de gel de la poche, des forces d'aspiration par la pompe pour une garantie de débit constant à chaque soutirage de gel.Such a bag is already adapted to an automated use requiring both a balancing between gel outlet pressures of the bag, suction forces by the pump for a constant flow guarantee at each withdrawal of gel.
Aussi l'invention se propose de résoudre ces problèmes ; la solution consiste à ce que le réservoir est une poche souple, hermétique et stérile reliée hermétiquement par une tubulure ou moyens d'amenée équivalent à une pompe hermétique et stérile, reliée elle-même hermétiquement à au moins une sonde et caractérisée en ce qu'elle présente une ouverture d'approvisionnement et de distribution unique et pour le moins centrée pour mettre à profit l'effet gravitaire et la vidange de la poche sans aucun appel d'air compensatoire.Also the invention proposes to solve these problems; the solution consists in that the reservoir is a flexible pouch, hermetic and sterile hermetically connected by a tubing or means of supply equivalent to a hermetic and hermetic pump, connected itself hermetically to at least one probe and characterized in that it has a single supply opening and distribution and at least centered to take advantage of the gravitational effect and emptying the pocket without any call compensatory air.
En effet considérant le mode de fabrication des poches vides stériles en PVC, avec des sites d'accès avec ou sans aiguilles (trocart), adaptées aux diverses pratiques médicales, il fallait un contenant bien moins technique tout en conservant la propriété plastique des membranes constituant l'enveloppe externe des dites poches. Avantageusement l'invention met à profit la gravité s'exerçant sur le gel et la pression atmosphérique s'exerçant sur les parois souples des poches pour assurer un approvisionnement en circuit sans appel d'air et retour de gel , partant en évitant tout risque de contamination par l'environnement direct de la poche. De plus moins il y a d'ouvertures, moins il y a de risques pour voir une de ces ouvertures être la source d'une contamination. En outre elle facilite la production et !a mise en œuvre de ces poches en permettant autant le remplissage que le vidage de ces dernières en respect de toutes les considérations sanitaires et en usage.Indeed considering the method of manufacture of empty PVC empty pockets, with access sites with or without needles (trocar), adapted to various medical practices, it needed a much less technical container while retaining the plastic property of the membranes constituting the outer envelope of said pockets. Advantageously, the invention takes advantage of the gravity exerted on the gel and the atmospheric pressure exerted on the flexible walls of the pockets to ensure a supply circuit without air and return of gel, thus avoiding any risk of contamination by the direct environment of the pocket. The fewer openings there are, the less risk there is to see one of these openings being the source of contamination. In addition it facilitates the production and implementation of these pockets by allowing both the filling and emptying of the latter in respect of all health considerations and in use.
L'invention sera mieux comprise à la lecture d'un exemple non limitatif de mise en œuvre de la présente invention qui va maintenant être décrit au regard des figures annexées :The invention will be better understood on reading a nonlimiting example of implementation of the present invention which will now be described with reference to the appended figures:
- La Fig. 1 est un organigramme représentant différentes étapes du procédé fabrication de gel selon l'invention ;FIG. 1 is a flow chart showing various steps of the gel manufacturing method according to the invention;
- La Fig. 2 représente schématiquement une poche selon l'invention et selon un mode de réalisation avec tubulure manchon pouvant être obturée avec un bouchon ;FIG. 2 schematically represents a pocket according to the invention and according to an embodiment with a sleeve pipe which can be closed with a plug;
- La Fig. 3 représente schématiquement un échographe avec fixée à poste la poche de la Fig. 2.FIG. 3 schematically shows an echograph with attached to the pocket of FIG. 2.
- La Fig. 4 représente en courbe les résultats atteints par le gel (BCL) selon l'invention par rapport aux gels de l'état de la techniqueFIG. 4 represents in curve the results achieved by the gel (BCL) according to the invention compared to the gels of the prior art
La poche souple 1 représentée sur les Fig. dispose de parois 2 constituant son enveloppe, assez fines pour suivre toute conformation du gel G lors du soutirage de ce dernier par la pompe P d'alimentation du gei G à la sonde ultrasonique S et sous l'effet de la pression atmosphérique ambiante et sans altération de la force de succion de ladite pompe P. La conformation de poche 1 et la souplesse des parois 2 offrent une surface importante permettant un échange thermique rapide et important réalisant un équilibrage de la température du gel G avec celle ambiante. Dans une autre variante de réalisation la dite poche 1 peut le cas échéant être logée dans un logement L solidaire de la pompe P et comportant des dispositifs de réchauffage tels que des résistances R du gel G à la température de confort ambiante.The flexible pouch 1 shown in Figs. has walls 2 constituting its envelope, thin enough to follow any conformation of the gel G during the racking of this last by the pump P supply of gei G to the ultrasonic probe S and under the effect of ambient atmospheric pressure and without altering the suction force of said pump P. The pocket conformation 1 and the flexibility of the walls 2 provide a large area for rapid and significant heat exchange achieving a balancing of the temperature of the gel G with that ambient. In another variant embodiment, said pocket 1 may, if appropriate, be housed in a housing L integral with the pump P and comprising heating devices such as resistors R of the gel G at the ambient comfort temperature.
La poche 1 dispose à son extrémité opposée à l'ouverture 3 d'un moyen d'ancrage ou d'accrochage 4 pour permettre son positionnement à poste sur ou à proximité de l'échographe pour mettre à profit l'effet gravitaire sur le gel G.The pocket 1 has at its end opposite the opening 3 of an anchoring or hooking means 4 to allow its positioning at or near the ultrasound system to take advantage of the gravitational effect on the gel BOY WUT.
Ladite ouverture 3 est représentée avec un manchon tubulaire souple ouvert 5 avec au droit de son orifice une représentation schématique du moyen de scellement tel qu'un bouchon 6 décrit dans l'invention.Said opening 3 is shown with an open flexible tubular sleeve 5 with a schematic representation of the sealing means, such as a plug 6 described in the invention, at its orifice.
La poche 1 est amovible et remplaçable par toute autre poche de même nature et de contenance adaptée aux caractéristiques de l'acte pratiqué et typiquement calibrée à 250, 500 ou 1000 millilitres. L'invention permet in fine d'adapter le volume requis idéal pour des séries d'actes types.The pocket 1 is removable and replaceable by any other pocket of the same type and capacity adapted to the characteristics of the practiced act and typically calibrated at 250, 500 or 1000 milliliters. The invention ultimately makes it possible to adapt the ideal volume required for series of standard acts.
La poche 1 , la pompe P et les différents tubes T d'écoulement du gel G forment un circuit hermétique et stérile à ouverture unique sur la sonde S.The pocket 1, the pump P and the various tubes G of the gel flow G form a hermetic and sterile circuit with a single opening on the probe S.
Ce qui permet est d'isoler le gel dans la poche souple 1 à usage unique, partie intégrante d'un circuit fermé.What allows is to isolate the gel in the flexible pouch 1 disposable, integral part of a closed circuit.
Ainsi, de manière avantageuse, la pompe péristaltique P ne présente aucun contact avec le gel G. Aucun retour de gel G n'est possible, partant aucun retour de gel G de la sonde S.Thus, advantageously, the peristaltic pump P has no contact with the gel G. No return of gel G is possible, hence no gel return G of the probe S.
Ainsi pour répondre à divers types d'examen et de sondes S et ou pour personnaliser au mieux la technique de l'imagerie médicale par ultrasons aux réflexes, usages et sensibilités de l'opérateur échographe, l'invention met en œuvre les gels actuels du commerce G1 , G2 en l'état sanitaire requis à leur stade de fabrication et ou à leur stade de conditionnement optimum de 1000 ml en procédant à une reformulation dudit gel sous atmosphère ambiante contrôlée en ce que le nouveau gel reformulé G selon l'invention est réalisé par la combinaison d'au moins deux types de gel connu, le premier étant à macromolécules synthétiques de type carbomère et le deuxième étant à macromolécules naturelles du type cellulose et au moins de l'eau stérile H2O.Thus, in order to respond to various types of examinations and S probes and to better customize the technique of ultrasound medical imaging to the reflexes, uses and sensitivities of the ultrasound operator, the invention implements the current gels of G1, G2 trade in the sanitary state required at their stage of manufacture and / or at their optimum 1000 ml packaging stage by reformulation of said gel under controlled ambient atmosphere in that the new reformulated gel G according to the invention is produced by the combination of at least two types of known gel, the first being synthetic macromolecules of the carbomer type and the second being made of natural macromolecules of the cellulose type and at least sterile H2O water.
L'invention pour autant n'est pas tenue de procéder en aval du processus de fabrication des dits gels du commerce G1 , G2 et peut dans les deux cas de réalisation qui précèdent procéder à la fabrication directement en atmosphère ambiante stérile desdits gels (G) reformulés directement à partir de chacune des macromolécules naturelles ou synthétiques, seules ou combinée et en combinaison avec de l'eau stérile.The invention therefore is not required to proceed downstream of the manufacturing process of said commercial gels G1, G2 and can in both cases of realization which proceed to the manufacture directly in sterile ambient atmosphere of said gels (G) reformulated directly from each of the natural or synthetic macromolecules, alone or in combination and in combination with sterile water.
Pour satisfaire des considérations de coûts et environnementales, l'invention réalise la reformulation desdits gels ou la production des dits gels par combinaison obtenue en atmosphère naturelle contrôlée à température ambiante, étape C.To meet cost and environmental considerations, the invention realizes the reformulation of said gels or the production of said gels by combination obtained in a controlled natural atmosphere at room temperature, step C.
La réalisation de la combinaison des composants du gel et de l'eau stérile est obtenue suite à un brassage doux et régulier, sans contrainte d'éviction des bulles d'air, étape B. L'addition d'une certaine quantité d'eau stérile aux concentrations actuelles connues suffit déjà pour obtenir un gel de fluidité améliorée par au moins deux fois celle des gels du commerce. Le conditionnement et la sortie gravitaire du fluide concentrent les bulles dans le contenant et ou s'échappent du circuit de distribution automatisé de l'échographe.The realization of the combination of the gel components and the sterile water is obtained following a smooth and regular mixing, without constraint of eviction of air bubbles, step B. The addition of a certain amount of water Sterile at current known concentrations is already sufficient to obtain a fluidity gel improved by at least twice that of commercial gels. The conditioning and the gravitational outlet of the fluid concentrate the bubbles in the container and or escape from the automated dispensing circuit of the ultrasound system.
En jouant sur les concentrations d'eau distillée et les fréquences d'étapes B de brassages il est possible de proposer une limite haute de viscosité ainsi qu'une limite basse de fluidité qui permet de s'adapter à la technicité des sondes modernes S et à venir d'une part et d'autre part de répondre au besoin propre de l'opérateur selon sa spécialité ou ses usages. Ces valeurs de concentrations sont respectivement étalonnées par les paramètres 1/3, %, 1/5 de volume d'eau distillée pour un volume entier de macromolécules de bases conditionnées dans des concentrations actuelles connues du marché.By modifying the distilled water concentrations and the stirring frequency B, it is possible to propose a high viscosity limit and a low fluidity limit which makes it possible to adapt to the technical nature of the modern S probes. to come on the one hand and on the other hand to meet the specific needs of the operator according to his specialty or his uses. These concentration values are respectively calibrated by the parameters 1/3,%, 1/5 volume of distilled water for an entire volume of base macromolecules packaged in current known concentrations of the market.
Ce faisant l'invention a conçu et fabriqué un gel G, permettant de lever les problèmes énoncés et donc, de réunir les avantages d'une production très peu onéreuse, apte à être conditionné du début de la fabrication jusqu'à son utilisation en cours d'actes d'échographie sans risques de contamination par un quelconque environnement y compris celui de par des bulles d'air stérile, grâce à une reformulation rendant le gel G apte à une distribution automatisée et de surcroit personnalisable dans sa formulation à chaque opérateur échographe. Le gel G de l'invention est enrichi par de l'eau stabilisé en atmosphère ambiante naturelle par des étapes B de brassage successives entre des étapes Re de repos qui avantageusement le conserve plus .longtemps opérationnel car il sèche moins vite, glisse mieux et sa fluidité n'encombre nullement les dispositifs automatiques de distributions du conditionnement aux sondes S. La pratique de l'échographie non seulement permet d'optimiser la technologie actuellement offerte, mais elle optimise le diagnostic par une imagerie médicale temporelle et spatiale améliorée. Le dit gel G de l'invention ne colle pas, ne tâche pas et ne peut couler du fait de la réduction notoire des quantités nécessaires à l'examen du fait de la distribution automatisée sur la sonde S. Sa fluidité permet en outre de se mettre très rapidement à température ambiante ou le cas échéant de supporter un réchauffement rapide sans perdre de sa consistance et ou de ses propriétés ; tout cela pour un véritable confort du patient.In doing so, the invention has designed and manufactured a gel G, making it possible to overcome the problems stated and thus to reap the advantages of a very inexpensive production, capable of being conditioned from the beginning of manufacture to its use in During ultrasound procedures without risk of contamination by any environment including that of sterile air bubbles, thanks to a reformulation making the gel G suitable for automated distribution and further customizable in its formulation to each operator ultrasound. The gel G of the invention is enriched with water stabilized in a natural ambient atmosphere by successive stirring steps B between resting stages Re which advantageously retains it for a longer time because it dries less quickly, slides better and its fluidity in no way encumbers the automatic devices of distribution of the conditioning to the probes S. The practice of the echography not only makes it possible to optimize the currently offered technology, but it optimizes the diagnosis by an improved temporal and spatial medical imagery. The said gel G of the invention does not stick, does not stain and can not flow because of the notorious reduction of the quantities necessary for examination because of the automated distribution on the probe S. Its fluidity also makes it possible to put very quickly at room temperature or, if necessary, withstand rapid heating without losing its consistency and / or properties; all this for a real comfort of the patient.
La liaison de la poche 1 se fait avec une tubulure 5 ou équivalent reliant la poche 1 à une pompe P d'approvisionnement des sondes ultrasoniques S. L'ouverture de la poche aboute la tubulure souple 5 de longueur suffisante et appropriée à l'approvisionnement et à l'introduction hermétique d'un bouchon 6 après sectionnement à hauteur dudit bouchon de l'extrémité du tube d'alimentation de la nourrice. L'invention se propose d'être aussi minimaliste que possible pour ne conserver que ce qui est essentiel à une mise en œuvre pratique et sanitaire. La solution consiste en deux modes d'exécution présentant dans un premier mode l'ouverture 3 qui comporte une couronne renforcée formant une lèvre périphérique circulaire renforcée de diamètre sensiblement égal au diamètre externe des embouts de remplissage et au diamètre des extrémités de la tubulure d'approvisionnement et dans un second mode, l'ouverture comporte une tubulure souple (5) ou manchon solidaire inamovible de ladite ouverture, de diamètre sensiblement égal au diamètre externe des embouts de remplissage et au diamètre des extrémités de la tubulure d'approvisionnement 5The connection of the bag 1 is made with a tubing 5 or equivalent connecting the bag 1 to a pump P supply ultrasonic probes S. The opening of the pocket abuts the flexible tubing 5 of sufficient length and suitable for supply and the hermetic introduction of a plug 6 after severing at said plug of the end of the feed tube of the nurse. The invention proposes to be as minimalist as possible to keep only what is essential to a practical and sanitary implementation. The solution consists of two embodiments having in a first embodiment the opening 3 which comprises a reinforced ring forming a reinforced peripheral peripheral lip of diameter substantially equal to the external diameter of the filling tips and to the diameter of the ends of the tubing of FIG. supply and in a second mode, the opening comprises a flexible tubing (5) or immovably integral sleeve of said opening, of diameter substantially equal to the outer diameter of the filling tips and the diameter of the ends of the supply tubing 5
Avantageusement après remplissage de tels orifices ou manchon 5 peuvent être •bouchées ou occultées jusqu'à leur emploi par des dispositifs sécables ou perforables 6. Avantageusement il suffit à l'échographiste de sectionner ou de perforer par simple pression de l'extrémité de tubulure 5 ou de retirer les moyens d'obturation 6 et d'insérer dans Ie manchon 5 ou la couronne, l'extrémité du tube T d'alimentation de la pompe P d'alimentation en gel G de la sonde ultrasonique S.Advantageously after filling such openings or sleeve 5 may be clogged or occluded • until used by breakable or pierceable devices 6. Advantageously it is sufficient for the sonographer to cut or perforate by simply pressing the end of the tubing 5 or to remove the closure means 6 and to insert into the sleeve 5 or the crown, the end of the tube T supply of the gel supply pump G of the ultrasonic probe S.
L'invention réaiise une ouverture unique 3 qui aboute selon les moyens retenus une couronne renforcée ou une tubulure souple 5 de longueur suffisante et tous deux moyens étant dimensionneilement appropriés à la connexion directe et sans accessoires des moyens d'introduction et/ou d'extraction du gel ultrasonique G tout en autorisant des moyens de scellement de telles ouvertures avec des moyens hermétiques sécables ou perforables et/ou encore à l'introduction hermétique d'un bouchon stérile 6.The invention provides a single opening 3 which abuts, according to the means retained, a reinforced crown or a flexible tubing 5 of sufficient length and both means being dimensionally suitable for the direct connection and without accessories of the introduction and / or extraction means. ultrasonic gel G while allowing means for sealing such openings with hermetic means breakable or perforable and / or the hermetic introduction of a sterile plug 6.
En effet la mise au repos ou en veille d'une installation échographique pour des raisons de maintenance ou des périodes d'inactivité nécessite la déconnection des fournitures consommables comme la poche 1 de gel G. C'est pourquoi l'invention prévoit de fournir avec toutes poches 1 de gel G au moins un bouchon 6 de composition identique à celle de l'enveloppe 2 des poches 1 et ce dans un emballage stérile. Avantageusement le dit bouchon 6 est conformé dimensionneliement pour s'insérer forcé dans l'embouchure de la tubulure 5 ou de la couronne de l'ouverture unique 3. Avantageusement un tel bouchon 6 peut être disposé sur la tubulure 5 du manchon après remplissage de la poche 1 auquel cas l'échographiste devra simplement sectionner le manchon tubulure 5 à sa hauteur et réalisé la jonction.Indeed the setting at rest or standby of an ultrasound installation for reasons of maintenance or periods of inactivity requires the disconnection of consumable supplies such as pocket 1 of gel G. This is why the invention provides to provide with all pockets 1 of gel G at least one plug 6 of composition identical to that of the envelope 2 of the bags 1 and this in a sterile package. Advantageously, said plug 6 is dimensionally adapted to be inserted into the mouth of the tubing 5 or the crown of the single opening 3. Advantageously, such a plug 6 can be placed on the tubing 5 of the sleeve after filling the plug. pocket 1 in which case the sonographer will simply cut the tubing sleeve 5 to its height and made the junction.
L'invention réalise donc une poche 1 , dans laquelle l'obturation de ladite tubulure est obtenue avec un bouchon 6 en matériau synthétique neutre adhérent à la paroi interne de la dite tubulure 5; l'obturation de ladite poche 1 est obtenue avec un bouchon 6 de matière et composition pour le moins similaire et compatible à celle de ladite pocheThe invention therefore provides a pocket 1, wherein the closure of said tubing is obtained with a plug 6 of neutral synthetic material adhering to the inner wall of said tubing 5; the closure of said pocket 1 is obtained with a plug 6 of material and composition for the least similar and compatible with that of said pocket
1 et adhèrent à la paroi interne de ladite tubulure ou couronne 5 de l'ouverture unique 3.1 and adhere to the inner wall of said tubing or crown 5 of the single opening 3.
La poche 1 contient une solution nettoyante et stérilisante adaptée pour le moins aux besoins d'entretien et de mise en veille prolongée du circuit. Cette possibilité permet de surabonder la garantie de bon fonctionnement stérile de l'échographe et pare à d'éventuels dépôts pouvant créer des turbulences ou des gênes dans le flux du gel G en suite de mise en veille prolongée des appareils ou d'un arrêt conséquent ou phénomènes exogènes, comme par exemple des modifications substantielles de la température amenant des modifications structurelles du gel G.The pocket 1 contains a cleaning and sterilizing solution adapted at least for the needs of maintenance and hibernation of the circuit. This possibility makes it possible to increase the guarantee of sterile good performance of the ultrasound system and avoids any deposits that may create turbulence or discomfort in the flow of the gel G as a result of hibernation of the devices or a consequent stoppage. or exogenous phenomena, such as, for example, substantial changes in the temperature leading to structural modifications of the gel G.
Le gel G est de façon permanente et pérenne au contact de et enveloppé par la membrane souple 2 de la dite poche 1. Avantageusement toute bulle d'air inconcevable pour une imagerie échographique de qualité peut du fait de la fluidité du gel ultrasonique G de l'invention s'échapper et se cantonner dans la partie supérieure Air de la poche2.The gel G is permanently and permanently in contact with and wrapped by the flexible membrane 2 of said bag 1. Advantageously any inconceivable air bubble for quality ultrasound imaging can because of the fluidity of the ultrasonic gel G of the escape and be confined in the upper air part of the pocket2.
Il ressort de la lecture des dessins Iles solutions atteintes par l'invention et les limitations des gels de l'état de la techniqueIt appears from reading the drawings Iles solutions reached by the invention and the limitations of the gels of the state of the art
L'état de la technique se limite à partir des gels à macromolécules naturelles de type "cellulose et approvisionnés dans le commerce directement aux échographistes et auxquels s'appliquent les concentrations 1/3, %, 1/5 d'eau distillée. Selon la revendication 1 « ...est au moins réalisé par la combinaison d'au moins un gel...cellulose... » et à partir des gels à macromolécules synthétiques de type carbomères et approvisionnés dans le commerce directement aux échographistes et auxquels s'appliquent les concentrations 1/3, %, 1/5 d'eau distillée. Selon la revendication 1 « ...est au moins réalisé par la combinaison d'au moins un geL.carbomère... »The state of art is limited from natural macromolecules gels of type "cellulose and supplied commercially directly to sonographers and to which the concentrations 1/3,%, 1/5 of distilled water. According to the claim 1 "is at least achieved by the combination of at least one gel ... cellulose ..." and from synthetic macromolecule gels type carbomers and commercially supplied directly to sonographers and s' apply the concentrations 1/3,%, 1/5 of distilled water According to claim 1 "... is at least achieved by the combination of at least one geL.carbomer ..."
Même à partir de la combinaison des gels à macromolécules naturelles de type cellulose et des gels à macromolécules synthétiques de type carbomères et approvisionnés dans le commerce directement aux échographistes et auxquels s'appliquent les concentrations 1/3, %, 1/5 d'eau distillée. Selon la revendication 2 .déposée.Even from the combination of cellulose-type natural macromolecule gels and carbomer-type synthetic macromolecule gels, commercially supplied directly to sonographers and to which the 1/3,%, 1/5 concentrations of water are applied distilled. According to Claim 2, filed.
Cet état de la technique n'enseigne pas de partir de bases macromoléculaires aussi bien naturelles de type cellulose que synthétiques de type carbomères non disponibles directement pour l'échographiste et pourtant une telle solution meilleurs que l'état de la technique appliquent des concentrations supérieures que celles de l'invention comme cela ressort des courbes de la Rg. 4.This state of the art does not teach starting from macromolecular bases, both natural cellulose type and synthetic carbomer type not available directly to the sonographer and yet such a solution better than the state of the art apply higher concentrations than those of the invention as is apparent from the curves of the Rg. 4.
Le gel G selon l'invention, approprié à la transmission d'ondes ultrasoniques aux fins d'actes médicaux, paramédicaux et/ou vétérinaires, lequel gel G est réalisé par au moins un gel G1 à macromolécules naturelles du type cellulose et au moins de J'eau H2O, caractérisé en ce que ledit gel G étant pour nourrice de sonde S débouchant par au moins un orifice à proximité de la fenêtre d'émission et/ou de réception des signaux de la sonde S est au moins réalisé par la combinaison d'au moins un gel à macromolécules naturelles du type cellulose ou synthétiques de type carbomère et au moins de l'eau stérile, réalisation directement en atmosphère ambiante stérile desdits gels G reformulés directement à partir de chacune des macromolécules naturelles ou synthétiques, seules ou combinée et en combinaison avec de l'eau stérile, ledit gel étant ensuite isolé dans une poche souple 1 à usage unique, partie intégrante d'un circuit fermé pour permettre un acte d'échographie en un seul tenant, de façon continue et performante, en respectant tous les codes d'hygiène et de mode opératoire stérile préconisés et ou souhaités en la matière et ce dès la production dudit gel G.The gel G according to the invention, suitable for the transmission of ultrasonic waves for the purposes of medical, paramedical and / or veterinary procedures, which gel G is produced by minus a G1 gel with natural macromolecules of the cellulose type and at least H2O water, characterized in that said gel G being for probe nipple S opening through at least one orifice near the emission window and / or the signal S is received at least by the combination of at least one gel of macromolecules natural cellulose type or synthetic carbomer type and at least sterile water, production of said reformulated G gels directly in a sterile ambient atmosphere. directly from each of the natural or synthetic macromolecules, alone or combined and in combination with sterile water, said gel being then isolated in a disposable flexible pouch 1, part of a closed circuit to allow ultrasound in a single piece, continuously and efficiently, respecting all the codes of hygiene and sterile procedure recommended and or desired in the mat first and foremost since the production of said gel G.
La Fie. 3 représente 3 représente les trois différentes étapes du mode de fabrication d'un des six modes de réalisation du gel. Elle présente trois entrées G1 ou G2 en combinaison avec H2O.The Fie. 3 represents 3 represents the three different steps of the method of manufacturing one of the six embodiments of the gel. It has three inputs G1 or G2 in combination with H2O.
Les essais représentés Fig. 4 ont montré que la viscosité du gel BCL selon l'invention reste toujours proche de 40 000 Cps pour des températures allant de 16 à 310C alors que la viscosité des gels de l'état de la technique varie de manière beaucoup trop élevée en passant pour l'un de plus de 70 000 Cps et l'autre de plus de 50 OOOCps à 16 0C à respectivement 10 000 Cps et 20 000 Cps à 310C.The tests shown in FIG. 4 have shown that the viscosity of the BCL gel according to the invention always remains close to 40,000 Cps for temperatures ranging from 16 to 31 ° C. whereas the viscosity of the gels of the state of the art varies in a way that is much too high. passing for one of more than 70 000 Cps and the other more than 50 OOOCps at 16 0 C respectively at 10 000 Cps and 20 000 Cps at 31 0 C.
De même le pouvoir agglomérant du gel selon l'invention est beaucoup plus stable que celui des gels connus. Ces caractéristiques permettent d'utiliser un circuit souple pour distribuer le gel.Similarly, the agglomerating power of the gel according to the invention is much more stable than that of known gels. These characteristics make it possible to use a flexible circuit for dispensing the gel.
L'utilisation d'un circuit de fluide comprenant au moins une poche souple 1 hermétique et stérile, reliée hermétiquement via un tube semi-rigide T à un ensemble pompe P relié hermétiquement via un tube T semi-rigide sur au moins une partie de sa longueur pour alimenter en gel GT la fenêtre d'émission et ou de réception des signaux d'une sonde S d'un échographe tel que décrit précédemment permet d'affranchir automatiquement l'opérateur de l'action parasite d'apport manuel de gel et pour prémunir le gel restant pour les actes ultérieurs de contact avec l'air, le patient ou tous autres sources ou facteurs de contamination. Cette solution est atteinte car l'étanchéité est assuré les deux sens, non seulement une étanchéité vers l'extérieur du circuit qui évite les fuites de gel hors distribution, mais aussi une étanchéité vers l'intérieur du circuit qui protège le gel des contacts avec l'air.The use of a fluid circuit comprising at least one hermetic and sterile flexible bag 1 hermetically connected via a semi-rigid tube T to a pump assembly P hermetically connected via a semi-rigid tube T to at least a part of its length for supplying GT gel the window for transmitting and / or receiving the signals of a probe S of an ultrasound machine as described above makes it possible to automatically clear the operator of the parasitic action of manual gel supply and to protect the remaining gel for subsequent acts of contact with air, the patient or any other sources or factors of contamination. This solution is reached because the tightness is ensured both ways, not only a seal towards the outside of the circuit which avoids the gel leakage out of distribution, but also a seal towards the inside of the circuit which protects the gel from the contacts with the air.
L'application du gel (G) se fait suite à passage par un circuit de fluide d'un échographe comprenant au moins la poche souple hermétique et stérile 1, reliée hermétiquement via le tube T à l'ensemble pompe P relié hermétiquement via le tube T pour alimenter en gel G la fenêtre d'émission et/ou de réception des signaux de la sonde S.The gel (G) is applied following passage through a fluid circuit of an ultrasound system comprising at least the hermetic and sterile flexible pouch 1, hermetically connected via the tube T to the pump assembly P hermetically connected via the tube T for supplying G with the window for transmitting and / or receiving the signals of the probe S.
Bien que l'invention ait été décrite en liaison avec des structures particulières, elle n'y est nullement limitée et on peut y apporter de nombreuses variantes.Although the invention has been described in connection with particular structures, it is in no way limited and many variations can be made.
Les combinaisons des différentes réalisations représentées sur les dessins ou décrites ci-dessus ne sortent pas du cadre de l'invention.The combinations of the different embodiments shown in the drawings or described above are not outside the scope of the invention.
SIGNES DE REFERENCEREFERENCE SIGNS
1. poche1. pocket
2. paroi enveloppe 3. ouverture2. wall envelope 3. opening
4. moyens d'ancrage ou d'accrochage4. means of anchoring or hooking
5. manchon tubulure5. tubing sleeve
6. bouchon6. stopper
G gel selon l'invention G1 gel à macromolécules naturellesG gel according to the invention G1 gel with natural macromolecules
G2 gel du type carbomèreG2 carbomer type gel
L logementHousing
P pompeP pump
R résistances C étape de combinaisonR resistors C combination step
B étape de brassageB brewing step
Re étape de reposRe rest stage
Les signes de référence insérés après les caractéristiques techniques mentionnées dans les revendications ont pour seul but de faciliter la compréhension de ces dernières et n'en limitent aucunement la portée. Les avantages du gel G et de la poche 1 conformes à l'invention sont indissociables et complètent ceux compris dans la demande de brevet N° 08/00475 au nom du demandeur. L'invention n'est non plus tenue et limitée par l'énoncé de ces derniers. The reference signs inserted after the technical features mentioned in the claims are only intended to facilitate the understanding of the latter and in no way limit the scope. The advantages of the gel G and the pocket 1 according to the invention are inseparable and complement those included in the patent application No. 08/00475 in the name of the applicant. The invention is no longer held and limited by the statement of the latter.

Claims

REVENDICATIONS
1) Gel (G) approprié à la transmission d'ondes ultrasoniques aux fins d'actes médicaux, paramédicaux et/ou vétérinaires, lequel gel (G) étant réalisé par au moins un gel (G1) à macromolécules naturelles du type cellulose et au moins de l'eau (H2O), caractérisé en ce que ledit gel (G) étant pour nourrice de sonde (S) débouchant par au moins un orifice à proximité de la fenêtre d'émission et/ou de réception des signaux de la sonde (S) est au moins réalisé par la combinaison d'au moins un gel à macromolécules naturelles du type cellulose ou synthétiques de type carbomère et au moins de l'eau stérile, réalisation directement en atmosphère ambiante stérile desdits gels (G) reformulés directement à partir de chacune des macrornolécules natureiles ou synthétiques, seules ou combinée et en combinaison avec de l'eau stérile, ledit gel étant ensuite isolé dans une poche souple (1) à usage unique, partie intégrante d'un circuit fermé pour permettre un acte d'échographie en un seul tenant, de façon continue et performante, en respectant tous les codes d'hygiène et de mode opératoire stérile préconisés et ou souhaités en la matière et ce dès la production dudit gel (G).1) Gel (G) suitable for the transmission of ultrasonic waves for medical, paramedical and / or veterinary purposes, which gel (G) being produced by at least one gel (G1) with natural macromolecules of the cellulose type and with less water (H2O), characterized in that said gel (G) being a probe nurse (S) opening through at least one orifice near the window for transmitting and / or receiving the signals of the probe (S) is at least carried out by the combination of at least one gel with natural macromolecules of the cellulose or synthetic type of carbomer type and at least sterile water, produced directly in sterile ambient atmosphere of said gels (G) reformulated directly to from each of the macromolecules natural or synthetic, alone or combined and in combination with sterile water, said gel being then isolated in a flexible pouch (1) for single use, part of a closed circuit to allow an act ultrasound in one piece, continuously and performing, respecting all the codes of hygiene and sterile procedure recommended and or desired in the field and from the production of said gel (G).
2) Gel selon la revendication 1 , lequel est réalisé par la combinaison d'au moins deux types de gel connu, le premier étant à macromolécules synthétiques de type carbomère (G2) et le deuxième étant à macromolécules naturelles du type cellulose et au moins de l'eau stérile (H2O).2) Gel according to claim 1, which is produced by the combination of at least two types of known gel, the first being synthetic macromolecules carbomer type (G2) and the second being natural macromolecules cellulose type and at least sterile water (H2O).
3) Gel selon la revendication 1 ou 2, dans lequel ladite combinaison est obtenue en atmosphère naturelle contrôlée à température ambiante, en particulier, la réalisation de la combinaison des composants du gel et de l'eau stérile est obtenue suite à un brassage doux et régulier, sans contrainte d'éviction des bulles d'air.3) Gel according to claim 1 or 2, wherein said combination is obtained in a controlled natural atmosphere at room temperature, in particular, the realization of the combination of gel components and sterile water is obtained following a gentle stirring and regular, without constraint of eviction of air bubbles.
4) Procédé de fabrication de gel conforme à l'une quelconque des revendications précédentes comprenant des étapes alternées de brassages (B) et de repos (Re) du mélange de ladite combinaison.4) A gel manufacturing method according to any one of the preceding claims comprising alternating steps of mixing (B) and rest (Re) of the mixture of said combination.
5) Procédé selon la revendication précédente, dans lequel les valeurs de concentrations sont respectivement étalonnées par les paramètres 1/3, %, 1/5 de volume d'eau distillée pour un volume entier de macromolécules de bases conditionnées dans des concentrations actuelles connues du marché.5) Method according to the preceding claim, wherein the concentration values are respectively calibrated by the parameters 1/3,%, 1/5 of volume of distilled water for an entire volume of base macromolecules packaged in current known market concentrations.
6) Poche souple (1) de gel ultrasonique (G) typiquement conforme à l'une quelconque des revendications 1 à 3, hermétique et stérile, reliée hermétiquement par des moyens d'amenée tels que tubes (T) ou équivalents à une pompe (P) elle-même reliée hermétiquement à au moins une sonde (S), caractérisé en ce qu'elle présente une ouverture (3) d'approvisionnement et de distribution unique et pour le moins centrée pour mettre à profit l'effet gravitaire et la vidange de la poche (1) sans aucun appel d'air compensatoire.6) flexible pouch (1) of ultrasonic gel (G) typically according to any one of claims 1 to 3, hermetic and sterile, hermetically connected by means of supply such as tubes (T) or equivalent to a pump ( P) itself hermetically connected to at least one probe (S), characterized in that it has a single supply and distribution opening (3) and at least centered to take advantage of the gravitational effect and the emptying the pocket (1) without any compensatory air call.
7) Poche (1) selon la revendication précédente, dans laquelle l'ouverture aboute une tubulure souple (5) de longueur suffisante et appropriée à l'approvisionnement et à l'introduction hermétique d'un bouchon (6) après sectionnement à hauteur dudit bouchon de l'extrémité du tube d'alimentation de la nourrice ; en particulier deux modes d'exécution présentant dans un premier mode l'ouverture (3) qui comporte une couronne renforcée formant une lèvre périphérique circulaire renforcée de diamètre sensiblement égal au diamètre externe des embouts de remplissage et au diamètre des extrémités de la tubulure d'approvisionnement et dans un second mode, l'ouverture comporte une tubulure souple (5) ou manchon solidaire inamovible de ladite ouverture, de diamètre sensiblement égal au diamètre externe des embouts de remplissage et au diamètre des extrémités de la tubulure d'approvisionnement.7) pocket (1) according to the preceding claim, wherein the opening abuts a flexible tubing (5) of sufficient length and suitable for the supply and the hermetic introduction of a plug (6) after cutting at said height; plug of the end of the feeding tube of the nanny; in particular two embodiments having in a first mode the opening (3) which comprises a reinforced ring forming a reinforced circular peripheral lip of diameter substantially equal to the outer diameter of the filling tips and the diameter of the ends of the tubing of supply and in a second mode, the opening comprises a flexible tubing (5) or immovably integral sleeve of said opening, of diameter substantially equal to the outer diameter of the filling tips and the diameter of the ends of the supply tubing.
8) Poche (1) selon la revendication précédente présentant tous deux moyens étant dimensionnellement appropriés à la connexion directe et sans accessoires des moyens d'introduction et/ou d'extraction du gel ultrasonique (G) tout en autorisant des moyens de scellement de telles ouvertures avec des moyens hermétiques sécables ou perforables et/ou encore à l'introduction hermétique d'un bouchon stérile (6).8) pocket (1) according to the preceding claim having both means being dimensionally suitable for direct connection and without accessories means for introducing and / or extracting the ultrasonic gel (G) while allowing sealing means such as openings with hermetic means breakable or perforable and / or the hermetic introduction of a sterile plug (6).
•9) Poche selon la revendication 7 ou 8, dans laquelle l'obturation de ladite tubulure est obtenue avec un bouchon (6) en matériau synthétique neutre adhérent à la paroi interne de la dite tubulure (5) ; l'obturation de ladite poche (1) est obtenue avec un bouchon (6) de matière et composition pour le moins similaire et compatible à celle de ladite poche (1) et adhèrent à la paroi interne de ladite tubulure ou couronne (5) de l'ouverture unique (3). 9) bag according to claim 7 or 8, wherein the closure of said tubing is obtained with a plug (6) of neutral synthetic material adhering to the inner wall of said tubing (5); the closure of said pocket (1) is obtained with a plug (6) of material and composition for the least similar and compatible with that of said pocket (1) and adhere to the inner wall of said tubing or crown (5) of the single opening (3).
PCT/FR2009/001115 2008-09-23 2009-09-21 Gel adapted for transmitting ultrasound waves, method for making said gel, and bag containing same WO2010034901A2 (en)

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FR08/05206 2008-09-23
FR0805206A FR2936156A1 (en) 2008-09-23 2008-09-23 GEL FOR ULTRASONIC WAVE TRANSMISSION, PROCESS FOR PRODUCING THE GEL AND POCKET CONTAINING THE SAME

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CN106344071A (en) * 2016-11-16 2017-01-25 珠海沃姆电子有限公司 Disposal high-definition imaging ultrasonic gel probe isolation sleeve and preparation method thereof
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