(19)
(11)EP 2 094 336 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
10.01.2018 Bulletin 2018/02

(21)Application number: 07840010.8

(22)Date of filing:  09.11.2007
(51)Int. Cl.: 
A61M 5/28  (2006.01)
A61M 39/02  (2006.01)
A61M 5/315  (2006.01)
A61M 5/19  (2006.01)
A61M 5/31  (2006.01)
A61M 25/00  (2006.01)
(86)International application number:
PCT/US2007/023654
(87)International publication number:
WO 2008/063439 (29.05.2008 Gazette  2008/22)

(54)

SYRINGE FOR SEQUENTIAL EXPRESSION OF DIFFERENT LIQUIDS AND METHOD OF USING SAME

SPRITZE ZUM SEQUENTIELLEN AUSDRÜCKEN UNTERSCHIEDLICHER FLÜSSIGKEITEN UND ANWENDUNGSVERFAHREN DAFÜR

SERINGUE POUR EXPRIMER SÉQUENTIELLEMENT DIFFÉRENTS LIQUIDES, ET SON PROCÉDÉ D'UTILISATION


(84)Designated Contracting States:
AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC MT NL PL PT RO SE SI SK TR

(30)Priority: 13.11.2006 IT PD20060419

(43)Date of publication of application:
02.09.2009 Bulletin 2009/36

(60)Divisional application:
17000554.0 / 3222310

(73)Proprietors:
  • Medical Components, Inc.
    Harleysville, PA 19438 (US)
  • NALESSO, Federico
    35010 Limena-Padova (IT)

(72)Inventors:
  • NALESSO, Federico
    35010 Limena-Padova (IT)
  • FISHER, Mark S.
    Sellersville, PA 18960 (US)
  • WALL, Shaun W.
    North Wales, PA 19414 (US)

(74)Representative: Callies, Rainer Michael 
Patentanwalt Fronhof 1
37581 Bad Gandersheim
37581 Bad Gandersheim (DE)


(56)References cited: : 
WO-A-2006/099441
FR-A- 2 612 782
US-A- 3 911 916
US-A- 5 540 667
US-A1- 2003 236 503
US-B1- 6 217 568
WO-A2-02/102279
US-A- 3 563 240
US-A- 5 344 407
US-A1- 2001 051 793
US-A1- 2007 073 267
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description


    [0001] This relates to the field of medical devices, and more particularly to syringes.

    [0002] As is known, vascular catheters, including central venous catheters, or CVCs, are medical devices for the infusion of pharmacological substances and fluids into a vessel of a patient, for example, the inner jugular, the subclavian, and the femoral vein, and for performing extracorporeal blood circulation during hemodialysis or other procedures which require extracorporeal blood circulation. Such vascular catheters can include, depending upon the operating requirements, one or more lumens; single-lumen, dual-lumen and triple-lumen catheters are generally used.

    [0003] The classical application of dual-lumen or triple-lumen catheters relates to extracorporeal circulation for performing chronic extracorporeal hemodialysis, such as for patients which chronic kidney failure, and for performing continuous renal replacement therapy, or CRRT, in critically ill patients in intensive care units. Single-lumen catheters are used to infuse drugs and liquids, to draw blood samples and to monitor pressures in certain vascular regions.

    [0004] Catheters can be of two main types: temporary and permanent. Temporary catheters are those which are placed for limited periods of time in patients who have acute requirements, whereas permanent catheters are placed to ensure chronic therapies and can have a working life of over three years. Since permanent catheters must ensure higher safety due to their permanent nature, they are provided with a subcutaneous portion between the entrance into the vein and the exit from the skin, so as to minimize the possible infections to which the patient is exposed. Any manipulation of any kind of central venous catheter, if not performed in fully aseptic conditions, can expose the patient to even fatal infection, since the CVC is placed in a central vein. Maintenance of the catheters after each use in a medical procedure is therefore particularly important in order to avoid infections and dysfunctions thereof.

    [0005] In addition to the problem of infection, catheters, by being in contact with blood, are in fact exposed to coagulation of the blood at the location of the openings of the lumens. Coagulation in the catheter lumen therefore causes malfunction thereof or even complete blockage of the catheter, with the consequent need to replace it in order to continue the medical therapies in progress. Currently, the lumen or lumens of the catheter, after each use, are washed by infusing physiological solution and is then medicated by infusing an anticoagulant in the lumen or lumens in order to avoid coagulation thereof, which anticoagulant expresses the physiological solution from the catheter lumens into the vasculature. The anticoagulant is subsequently evacuated by vacuum from the catheter's proximal end when next the catheter is to be used for hemodialysis. Since the anticoagulant must remain in place and must not enter the blood circulation of the patient, in order to avoid anticoagulation within the vasculature of the patient, the volume of anticoagulant applied to each catheter lumen used must match exactly the volume of the lumen used in the procedure.

    [0006] Currently, health workers who close a catheter are required to perform the following procedures for each lumen of the catheter: open a sterile syringe; open the vial of physiological solution; aspirate the physiological solution into the syringe; disconnect the device connected to the lumen of the catheter, such as an infusion syringe or tubing for dialysis or for extracorporeal circulation in other medical contexts; connect the syringe; infuse the physiological solution to perform washing; disconnect the syringe; open another sterile syringe, open the vial of anticoagulant solution; aspirate the anticoagulant solution into the syringe, paying particular attention to the aspirated volume; connect the syringe to the catheter lumen; infuse the anticoagulant in the exact filling volume of the lumen; disconnect the syringe; and apply the closure plug to the catheter lumen.

    [0007] As is evident from this sequence of operations, the maintenance procedure of a catheter is time-consuming and laborious. In view of the laboriousness, the risk of procedural errors on the part of an operator is obviously high. Typical errors can be, for example, the use of incorrect products in solution, the infusion of incorrect quantities, errors in connecting parts of the catheter, and so forth. In addition to the possibility of errors, which can lead to the need to remove the catheter or, in the worst case, to actions which damage the health of the patient, the time-related aspects of the operations that must be performed also have to be considered. The maintenance time of a catheter is in fact not negligible, and if it is necessary to perform this operation frequently, as in the case of a large number of patients, the total time is important and must be assessed in terms of management expense of the hospital ward.

    [0008] US2003/0236503A1 discloses a device for expressing liquids having two separate compartments for containing respective liquids. However, the device does not comprise a transverse resealable membrane and a used closure plug is not placed within a cavity.

    [0009] The aim of the present invention is to solve the problems linked to the maintenance of vascular catheters as described above. It is desired to reduce the number of operations linked to the maintenance of vascular catheters. It is also desired to reduce maintenance time with respect to maintenance of vascular catheters.

    [0010] US6217568B1 describes a device for expressing liquids having only one compartment for a liquid. The device comprises a closure plug that is initially affixed within a cavity by a friction fit between a transverse resealable membrane of the plug and a blunt piercing member. The piercing member has a relatively large diameter and may leave the membrane with a leaking or ineffective seal after removal of the member. Other embodiments of the known device use a threaded connection or a connection via an external clip for affixing the closure plug. The drawback of both embodiments is that the connection may inadvertently disengage.

    [0011] It is also desired to provide a device for catheter maintenance that is easy to use, that is safe for the practitioner and reliable in operation, and is flexible in its use.

    [0012] It is also desired to provide such a device that enables avoidance of infection risk and of anticoagulation phenomena in the patient.

    [0013] Briefly, one key aspect of the present invention is a device according to claim 1 that achieves the aforesaid desires and objectives, particularly for catheter maintenance. The device comprises a syringe having a support structure, two (or more) separate compartments in which respective liquids for lumen treatment are contained, a duct proximate the distal end which is in fluid communication with the compartments and extends through the syringe's distal end wall, and at least one plunger at the proximal end for infusing, according to a preset order, the different treatment liquids into the lumen by applying pressure to the liquid when the plunger is activated by the practitioner. The inventive syringe also enables sequential expression of different liquids into other medical devices.

    [0014] Embodiments of the invention are stated in the sub-claims 2 to 10. In one embodiment, there are two compartments arranged in series within the chamber of the syringe's support structure, along with a single plunger. A movable partition separates the compartments; a distal wall provides an outer end to the first compartment, while the plunger provides the outer end of the second compartment. Activation of the plunger applies pressure to the liquid in the second, or proximal, of the two compartments which relays pressure to the movable partition which in turn pressurizes the liquid in the first or distal of the compartments to express liquid from the first compartment firstly; when the movable partition approaches the distal wall, a piercing lance of the distal wall pierces a pierceable portion of the movable partition to create an exit for liquid in the second compartment which then can access the duct and be expressed from the syringe into the lumen of the catheter.

    [0015] In another embodiment, there are two compartments that are arranged in parallel, each with an associated plunger. A common access permits liquid from either compartment to be expressed through the duct at the distal end of the syringe.

    [0016] The syringe further includes a closure plug affixed to the support structure of the syringe at its distal end. The closure plug includes a through hole for fluid passage therethrough from the duct to the catheter lumen. The closure plug is adapted to be mechanically connected to a catheter proximal end in a manner such that the through hole establishes fluid communication with the catheter lumen. The closure plug includes a penetrable sealing membrane traversing the through hole for sealing except when liquid is being expressed from the syringe into the catheter lumen. A needle affixed to the distal chamber wall penetrates this membrane when desired. The closure plug is removably secured to the support structure in a plug-containing cavity by releasable securements being frangible tabs, so that upon completion of the maintenance treatment of the catheter, the syringe may be removed from the catheter while the closure plug detaches from the syringe and remains on the catheter proximal end to close off the lumen.

    [0017] Additional characteristics and advantages of the device of the present invention will become evident hereinbelow. Furthermore, such a device as the present invention can also be used for other purposes where sequential expression of different liquids is desired from the same syringe, including expression of liquid into a medical device, thus not being limited to maintenance treatment of catheters.

    [0018] The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention. In the drawings:

    Fig. 1 is a longitudinal sectional view of a device according to the present invention;

    Fig. 2 is a longitudinal sectional view of the device of Fig. 1, shown during the final step of infusing the maintenance treatment liquids into a lumen of a catheter with which it is used;

    Fig. 3 is a longitudinal sectional view of the device of Fig. 1 after infusion has been completed;

    Fig. 4 is a view of a portion of the device of Figs. 1 to 3 with a metering section for adjusting the amount of liquid to be infused in a first setting, applied thereto;

    Fig. 5 is a view of a the device portion of Fig. 4 illustrating the metering section in a second setting, related to a smaller amount of liquid to be infused;

    Fig. 6 is a the device portion of Figs. 4 and 5 taken at right angles thereto, of the metering section;

    Fig. 7 is a view of another embodiment of the inventive device having dual plungers and compartments in parallel and having a common duct access.



    [0019] In the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The terms "distal" and "proximal" refer, respectively, to directions closer to and away from the insertion tip of a catheter in an implantable catheter assembly. The terminology includes the words specifically mentioned, derivatives thereof and words of similar import. The embodiments illustrated below are not intended to be exhaustive or to limit the invention to the precise form disclosed. These embodiments are chosen and described to best explain the principle of the invention and its application and practical use and to enable others skilled in the art to best utilize the invention.

    [0020] With respect to Figures 1 to 3, a first embodiment of device 10 is shown, having a support structure 15 such as a syringe 18 having a cylindrical chamber 19, with a first compartment 11 and a second compartment 12. A physiological solution is present in the first compartment 11, and an anticoagulant liquid is present in the second compartment 12. Device 10 also includes a closure plug 13 to be associated with the lumen L of a catheter C (see Figures 2 and 3) being treated, whose proximal end is coupled to support structure 15 by virtue of a releasable securement arrangement 14.

    [0021] The device 10 further includes a plunger 16 and a duct 17. A duct 17 is in fluid communication with the first compartment 11, and ultimately to the second compartment 12, and extends through the closure plug 13; the duct preferably includes therethrough a preferably non-coring needle 22 that is rigidly coupled to and extends through the bottom wall 21 of chamber 19 of syringe 18, needle 22 being stabilized by and within axially extending flange 40 projecting distally (i.e., toward the catheter lumen L) from bottom or distal chamber wall 21. Activation of the plunger 16 will infuse liquid from the syringe into the interior of the lumen L of the catheter at the proximal end thereof, firstly the physiological liquid and subsequently the anticoagulant liquid, in preset order, thus treating the catheter lumen. One example of a physiological liquid is saline; one example of an anticoagulant is heparin.

    [0022] First and second compartments 11, 12 are separated from each other by a partition 20 that is movable within cylindrical chamber 19. First compartment 11 is defined between the bottom chamber wall 21 and the movable partition 20, while second compartment 12 is defined between movable partition 20 and plunger 16. Movable partition 20 includes a pierceable portion 23, which once pierced allows the liquid present in the second compartment 12 to flow out through duct 17 and needle 22 and into the lumen as activation of the plunger is continued. Piercing is accomplished such as by piercing lance 24 defined by a pointed portion 25 protruding proximally from the bottom chamber wall 21, toward movable partition 20. Such piercing occurs when movable partition 20, pushed by plunger 16, is translated toward bottom chamber wall 21 and pierceable portion 23 is pressed against pointed portion 25 and is pierced thereby. Piercing allows the passage of the anticoagulant liquid to and through the duct 17 and ultimately to the lumen L, as is clear from Figure 2.

    [0023] Support structure 15 also comprises a plug-containing cavity 26 inside of which the closure plug 13 is initially secured by a releasable securement arrangement 14. The releasable securement arrangement are frangible tabs 27 made of plastic material, and which lie between the internal wall of the plug-containing cavity 26 and the outside of plug 13. Tabs 27 are adapted to be broken with a rotary motion of the support structure 15 with respect to closure plug 13 when the plug is fixed to the proximal end of the catheter at lumen L. Simply put, the closure plug transfers from the syringe to the catheter proximal end during disconnection of the syringe from the catheter to continue sealing the catheter lumen thereafter until being later removed.

    [0024] Needle 22 lies within plug-containing cavity 26 and is sufficiently short for its sharp distal end to be recessed entirely within cavity 26; as a result, the needle does not protrude from the syringe once the closure plug 13 is removed, for the safety to the operator. The closure plug 13, in this embodiment, may be a bushing 28 that is internally threaded for coupling to the complementarity threaded end portion of lumen L, such as would be provided by a conventional luer connector (not shown) affixed to the catheter proximal end.

    [0025] Bushing 28 includes a centrally disposed tubular portion 30 through which is defined a passage or through hole 29; through hole 29 is aligned with lumen L when tubular portion 30 is received into the proximal end of lumen L after the device 10 is affixed to the proximal end of catheter C as seen in Fig. 1. Bushing 28 further includes a transverse sealing membrane 31 of self-sealing material which is conventionally known, such as of silicone material. Membrane 31 can be pierced by needle 22 passing therethrough during activation of the device (Fig. 2), and seals itself after needle 22 is withdrawn, as seen in Fig. 3, recovering the continuity interrupted by the needle, thus ensuring a barrier to the entrance of pathogenic agents into the lumen. Subsequently, it is possible to again pierce the membrane with the needle of the infusion syringe, when it is necessary to infuse drugs into the catheter, and as before the membrane reseals itself once the needle is extracted upon removal of the syringe from the catheter.

    [0026] Advantageously, the device 10 also comprises a metering section 32 for adjusting the amount of treatment liquid that is present in at least one of the compartments 11 and 12, as is depicted in Figures 4 to 6. In particular, metering section 32 is constituted by an internally threaded ring 33, which is screwed onto the proximal end portion of plunger 16 accessible to the practitioner. Ring 33 forms an adjustable stroke limit 34 for the plunger, which is suitable to abut against the proximal end of the syringe body 18.

    [0027] Graphic references or indicia 35 are provided on ring 33 and plunger 16 that cooperate with each other to indicate the amount of liquid that is desired to be infused into the lumen. As clearly shown in Figures 4 to 6, a rotation of ring 33 raises or lowers the stroke limit 34 of plunger 16, thus limiting its stroke by an amount which is indicated by the indicia provided between the ring and the plunger.

    [0028] With reference now to Figure 7, another embodiment of device 110 is illustrated. Device 110 is provided monolithically with two separate compartments, now designated by the reference numerals 111 and 112, which are arranged so as to work in parallel, each compartment being associated with a respective plunger 116a and 116b. A common access 140 to needle 122 protrudes from the bottom wall 121 of compartments 111 and 112. A metering section can be utilized with each plunger 116a, 116b, in similar fashion to that of Figures 4 to 6.

    [0029] It is evident that in other embodiments not shown in the figures the device can be constituted in practice by two separate parts, a first part composed of the support structure of the device in which it is integrated and a second part, which is separate from the first and is accessible by the practitioner and in which the compartments with respective liquids are present; the compartments can be connected to the needle for example by virtue of one or more flexible tubes (not shown).

    [0030] As seen in the embodiment of Figures 1 to 6, the device of the present invention is composed, like a normal pyrogen-free and sterile syringe, by a chamber inside of which is a movable plunger. The chamber is divided by a movable partition dividing the two compartments, inside of which are present the respective physiological washing solution and the anticoagulant solution. The plunger, upon activation, is capable of infusing the physiological solution contained in the first compartment by transferring the pressure through the second compartment and the partition which separates the two compartments. The partition is provided so that once it has ended its stroke for the infusion of the physiological solution it comes into contact with (piercing) to open a connection through the partition between the compartments so as to allow the anticoagulant solution contained in the second compartment to enter the lumen of the catheter under the thrust of the plunger. Once the infusion of the anticoagulant solution has ended, disconnection of the device allows to close the lumen of the catheter by screwing the plug which is already present on the device.

    [0031] The use of the device according to the present invention in order to provide maintenance treatment of a catheter, is carried out by the following steps:
    1. (a) opening the sterile package containing the syringe and removing it;
    2. (b) disconnecting the medical device from the proximal end of the catheter, thus exposing the lumen;
    3. (c) connecting the syringe to the catheter end to establish fluid communication with the distal end of the duct or needle;
    4. (d) sequentially infusing, in a single step, first the physiological washing solution and then the anticoagulant that is already preloaded in the syringe compartment to the precisely desired volume for the lumen of the catheter that is being closed; and
    5. (e) disconnecting the syringe, with consequent separation and closure of the catheter lumen by the closure plug previously incorporated into the syringe's distal end.


    [0032] The total number of operations or steps performed with the device of the present invention according to the method, which however is not part of the claimed invention, is distinctly less than half of the steps performed with convention methods.

    [0033] Accordingly, the procedure with the present inventive device is characterized by a reduced risk of infections contamination of the catheter, reduced handling of the catheter with concomitant reduced risk of contamination of the practitioner in the case of work on a patient affected by an infectious condition, such as hepatitis B and C or HIV-related infections; more practical closure in much shorter times; and, minimal errors linked to inaccuracies in the procedure and in the infused volumes, since the operations performed are sequential and inherent to the device itself.


    Claims

    1. A device (10,110) for expressing liquids, comprising:

    a support structure (15) having at least two separate compartments (11,12;111,112) for containing respective liquids;

    a distal wall (21,121) traversing the support structure proximate a distal end thereof;

    a duct (17) extending through the distal wall enabling liquid to exit the at least two compartments;

    at least one plunger (16;116a,116b) movably affixed to the support structure (15) proximate a proximal end thereof for infusing liquids from the device through the duct (17) upon activation of the at least one plunger; and

    a closure plug (13) removably attached to the support structure (15) at the distal end thereof for connecting with a liquid-receiving device (C), the closure plug having a transverse resealable membrane (31) with a selectively openable through passage allowing passage of liquids from the duct therethrough to enter the liquid-receiving device,

    wherein the closure plug (13) is initially affixed within a plug-containing cavity (26) at the distal end of the support structure (15) by frangible sections (27), and the closure plug (13) has a connection section to remain mechanically secured to the liquid-receiving device (C) upon connection therewith, and the frangible sections (27) are adapted to be broken to permit removal of the closure plug (13) from the support structure (15) upon completion of maintenance treatment of the liquid-receiving device (C) when the device (10) is removed from the liquid-receiving device (C),

    wherein the frangible sections are frangible tabs (27), which lie between an internal wall of the plug-containing cavity (26) and an outside of the closure plug (13) and which are adapted to be broken with a rotary motion of the support structure (15) with respect to the closure plug (13).


     
    2. The device (10,110) of claim 1, wherein the device is adapted to infuse the at least two liquids sequentially in a preselected order into the liquid-receiving device (C).
     
    3. The device (10,110) of claim 2, wherein one of said respective liquids is a physiological liquid and another is an anticoagulant, and the physiological liquid is infused first and the anticoagulant is infused thereafter.
     
    4. The device (10) of claim 2, wherein the support structure (15) defines a chamber (19) containing the at least two compartments (11,12), and the at least two compartments are aligned in series with a first compartment (11) being distal of the second compartment (12).
     
    5. The device (10) of claim 4, wherein the device (10) includes a single plunger (16) that defines a proximal end of the second compartment (12), the distal wall (21) of the support structure (15) defines a distal wall of the first compartment (11), and a movable partition (20) separates the first and second compartments (11,12), all such that activation of the plunger applies pressure to the liquid in the second compartment causing distal movement of the movable partition (20) which pressurizes the liquid in the first compartment to be expressed through the duct (17) to exit the chamber (19) for entering the liquid-receiving device (C).
     
    6. The device (10) of claim 5, wherein the movable partition (20) includes a pierceable portion (23) and the distal wall (21) includes a piercing portion (24,25) protruding toward the movable partition (20) in alignment with the pierceable portion (23), such that upon expression of the liquid in the first compartment (11) therefrom, the movable partition (20) moves into abutment with the distal wall (21) such that the piercing portion (24,25) pierces the pierceable portion (23) establishing an exit opening through which liquid in the second compartment (12) exits the support structure (15) through the duct (17) for entering into the liquid-receiving device (C).
     
    7. The device (10,110) of claim 1, wherein the distal wall (21,121) includes a needle (22,122) affixed thereto disposed in the duct (17) and protruding distally therefrom a short distance for penetrating the transverse resealable membrane (31) of the closure plug (13) to establish fluid communication between the device and the liquid-receiving device (C), while a distal tip of the needle (22,122) remains recessed within the support structure's distal end.
     
    8. The device (10,110) of claim 1, wherein the device further comprises a metering section (32) for adjusting an amount of at least one of the respective liquids in one of the compartments (11,12;111,112).
     
    9. The device (10) of claim 8, wherein the metering section (32) comprises an internally threaded ring (33) screwed onto the proximal end of a said plunger (16), the ring defining an adjustable stroke limit (34) for the plunger (16) by abutting a proximal end of the support structure (15), graphic references (35) that indicate the amount of liquid that can be infused being disposed on the ring and the plunger, and the ring (33) being selectively rotatable to select the desired liquid amount, whereby the ring raises or lowers the stroke limit (34) of the plunger by a distance associated with the selected amount indicated by the graphic references (35) that in turn limits the amount of liquid expressed from the one of the compartments (11,12).
     
    10. The device (110) of claim 1, wherein the support structure defines a chamber (19) containing the at least two compartments (111,112), and the at least two compartments are aligned in parallel, each compartment having a respective plunger (116a,116b) for expressing liquid therefrom, and the support structure providing a common access to the duct for liquid from each compartment (111,112) to exit the device (110) for entering the liquid-receiving device (C).
     


    Ansprüche

    1. Vorrichtung (10, 110) zum Ausdrücken von Flüssigkeiten umfassend:

    eine Trägerstruktur (15) mit wenigstens zwei getrennten Zwischenräumen (11, 12; 111, 112) zum Beinhalten jeweiliger Flüssigkeiten,

    eine eine Trägerstruktur benachbart zu einem distalen Ende davon durchquerende distale Wand (21, 121),

    einen sich durch die distale Wand erstreckenden Kanal (17) zum Ermöglichen eines Austritts von Flüssigkeit aus den wenigstens zwei Zwischenräumen,

    wenigstens einen an der Trägerstruktur (15) benachbart zu einem proximalen Ende davon beweglich befestigten Kolben (16; 116a, 116b) zum Infundieren von Flüssigkeiten aus der Vorrichtung durch den Kanal (17) auf eine Aktivierung des wenigstens einen Kolbens und

    einen abnehmbar an der Trägerstruktur (15) an dem distalen Ende davon befestigten Verschlussstopfen (13) zum Verbinden mit einer Flüssigkeit-aufnehmenden Vorrichtung (C), wobei der Verschlussstopfen eine transversale, wieder abdichtbare Membran (31) mit einem selektiv zu öffnenden Durchgang, der einen Durchgang von Flüssigkeiten von dem Kanal dadurch ermöglicht, um in die Flüssigkeit-aufnehmende Vorrichtung einzutreten, aufweist,

    wobei der Verschlussstopfen (13) anfänglich innerhalb eines einen Stopfen enthaltenden Hohlraums (26) an dem distalen Ende der Trägerstruktur (15) durch zerbrechliche Abschnitte (27) befestigt ist und der Verschlussstopfen (13) einen Verbindungsabschnitt aufweist, um an der Flüssigkeit-aufnehmenden Vorrichtung (C) auf eine Verbindung damit mechanisch gesichert zu bleiben, und die zerbrechlichen Abschnitte (27) angepasst sind, um zerbrochen zu werden, um ein Entfernen des Verschlussstopfens (13) von der Trägerstruktur (15) auf eine Vollendung einer Instandhaltungsbehandlung der Flüssigkeit-aufnehmenden Vorrichtung (C), wenn die Vorrichtung (10) von der Flüssigkeit-aufnehmenden Vorrichtung (C) entfernt wird, zuzulassen,

    wobei die zerbrechlichen Abschnitte zerbrechliche Lappen (27) sind, die zwischen einer inneren Wand des den Stopfen-enthaltenden Hohlraums (26) und einer Außenseite des Verschlussstopfens (13) liegen und die angepasst sind, über eine Drehbewegung der Trägerstruktur (15) bezüglich des Verschlussstopfens (13) zerbrochen zu werden.


     
    2. Vorrichtung (10, 110) nach Anspruch 1, wobei die Vorrichtung angepasst ist, die wenigstens zwei Flüssigkeiten sequentiell in einer vorausgewählten Reihenfolge in die Flüssigkeit-aufnehmende Vorrichtung (C) zu infundieren.
     
    3. Vorrichtung (10, 110) nach Anspruch 2, wobei eine der jeweiligen Flüssigkeiten eine physiologische Flüssigkeit und die andere eine antikoagulierende ist und die physiologische Flüssigkeit zuerst infundiert wird und die antikoagulierende danach infundiert wird.
     
    4. Vorrichtung (10) nach Anspruch 2, wobei die Trägerstruktur (15) eine die wenigstens zwei Zwischenräume (11, 12) enthaltende Kammer (19) definiert und die wenigstens zwei Zwischenräume reihenweise ausgerichtet sind, wobei der erste Zwischenraum (11) distal bezüglich des zweiten Zwischenraums (12) vorgesehen ist.
     
    5. Vorrichtung (10) nach Anspruch 4, wobei die Vorrichtung (10) einen einzelnen Kolben (16) enthält, der ein proximales Ende des zweiten Zwischenraums (12) definiert, die distale Wand (21) der Trägerstruktur (15) eine distale Wand des ersten Zwischenraums (11) definiert und eine bewegliche Trennwand (20) den ersten und zweiten Zwischenraum (11, 12) trennt, alles derart, dass eine Aktivierung des Kolbens Druck auf die Flüssigkeit in dem zweiten Zwischenraum anwendet, was eine distale Bewegung der beweglichen Trennwand (20) hervorruft, welche die Flüssigkeit in dem ersten Zwischenraum mit Druck beaufschlägt, um durch den Kanal (17) ausgedrückt zu werden, um die Kammer (19) zum Eintritt in die Flüssigkeit-aufnehmende Vorrichtung (C) zu verlassen.
     
    6. Vorrichtung (10) nach Anspruch 5, wobei die bewegliche Trennwand (20) einen durchbohrbaren Abschnitt (23) enthält und die distale Wand (21) einen durchbohrbaren, zu der beweglichen Trennwand (20) in Ausrichtung mit dem durchbohrbaren Abschnitt (23) vorstehenden Abschnitt (24, 25) derart enthält, dass auf ein Ausdrücken der Flüssigkeit in dem ersten Zwischenraum (11) daraus sich die bewegliche Trennwand (20) in eine Widerlagerung mit der distalen Wand (21) bewegt, sodass der durchbohrbare Abschnitt (24, 25) den durchbohrbaren Abschnitt (23) durchbohrt, wobei eine Ausgangsöffnung geschaffen wird, durch welche Flüssigkeit in dem zweiten Zwischenraum (12) die Trägerstruktur (15) durch den Kanal (17) zum Eintreten in die Flüssigkeit-aufnehmende Vorrichtung (C) verlässt.
     
    7. Vorrichtung (10, 110) nach Anspruch 1, wobei die distale Wand (21, 121) eine daran befestigte, in dem Kanal (17) angeordnete und distal davon eine kurze Entfernung zum Eindringen in die transversale, wieder abdichtbare Membran (31) des Verschlussstopfens (13) vorstehende Nadel enthält, um eine Flüssigkeitsverbindung zwischen der Vorrichtung und der Flüssigkeit-aufnehmenden Vorrichtung (C) herstellt, während eine distale Spitze der Nadel (22, 122) innerhalb des distalen Endes der Trägerstruktur zurückgezogen verbleibt.
     
    8. Vorrichtung (10, 110) nach Anspruch 1, wobei die Vorrichtung weiter einen Messabschnitt (32) zur Einstellung einer Menge wenigstens einer der jeweiligen Flüssigkeiten in einem der Zwischenraume (11, 12; 111, 112) umfasst.
     
    9. Vorrichtung (10) nach Anspruch 8, wobei der Messabschnitt (32) einen im Inneren mit einem Gewinde versehenen, auf das proximale Ende des Kolbens (16) geschraubten Ring (33) umfasst, welcher Ring eine einstellbare Hubgrenze (34) für den Kolben (16) durch ein Anstoßen an ein proximales Ende der Trägerstruktur (15) definiert, wobei graphische Hinweiszeichen (35), welche die Menge von Flüssigkeit anzeigen, die infundiert werden kann, auf dem Ring und dem Kolben angeordnet sind und wobei der Ring (33) selektiv drehbar ist, um die gewünschte Flüssigkeitsmenge auszuwählen, wobei der Ring die Hubgrenze (34) des Kolbens über eine mit der ausgewählten Menge verbundene, durch die graphischen Hinweiszeichen (35) angezeigte Entfernung erhöht oder erniedrigt, die wiederum die Menge von aus einem der Zwischenräume (11, 12) ausgedrückter Flüssigkeit begrenzt.
     
    10. Vorrichtung (10) nach Anspruch 1, wobei die Trägerstruktur eine die wenigstens zwei Zwischenräume (111, 112) enthaltende Kammer (19) definiert, und die wenigstens zwei Zwischenräume parallel ausgerichtet sind, wobei jeder Zwischenraum einen jeweiligen Kolben (116A, 116B) zum Ausdrücken von Flüssigkeit daraus aufweist und die Trägerstruktur einen gemeinsamen Zugang zu dem Kanal für Flüssigkeit aus jedem Zwischenraum (111, 112) bereitstellt, um die Vorrichtung (110) zum Eintreten in die Flüssigkeit-aufnehmende Vorrichtung (C) zu verlassen.
     


    Revendications

    1. Dispositif (10, 110) servant à exprimer des liquides, comprenant :

    une structure de support (15) comportant au moins deux compartiments distincts (11, 12 ; 111, 112) destinés à contenir des liquides respectifs ;

    une paroi distale (21, 121) traversant la structure de support à proximité d'une extrémité distale de celle-ci ;

    un conduit (17) s'étendant à travers la paroi distale permettant au liquide de sortir des au moins deux compartiments ;

    au moins un piston (16 ; 116a, 116b) fixé de manière mobile à la structure de support (15) à proximité d'une extrémité proximale de celle-ci pour infuser des liquides à partir du dispositif à travers le conduit (17) lors de l'activation du ou des pistons ; et

    un bouchon de fermeture (13) fixé de manière amovible à la structure de support (15) au niveau de l'extrémité distale de celle-ci à des fins de raccordement avec un dispositif de réception de liquides (C), le bouchon de fermeture comportant une membrane transversale refermable (31) avec un passage traversant ouvrable de manière sélective permettant le passage de liquides à partir du conduit à travers lui de sorte qu'ils pénètrent dans le dispositif de réception de liquides,

    dans lequel le bouchon de fermeture (13) est initialement fixé à l'intérieur d'une cavité de réception de bouchon (26) au niveau de l'extrémité distale de la structure de support (15) par des sections cassables (27), et le bouchon de fermeture (13) comporte une section de raccordement destinée à rester assujettie mécaniquement au dispositif de réception de liquides (C) lors de son raccordement avec celui-ci, et les sections cassables (27) sont conçues pour être rompues afin de permettre le retrait du bouchon de fermeture (13) de la structure de support (15) à la suite de l'achèvement d'un traitement d'entretien du dispositif de réception de liquides (C) lorsque le dispositif (10) est retiré du dispositif de réception de liquides (C), dans lequel les sections cassables sont des pattes cassables (27), qui se trouvent entre une paroi intérieure de la cavité de réception de bouchon (26) et une partie extérieure du bouchon de fermeture (13) et qui sont conçues pour être rompues par le biais d'un mouvement de rotation de la structure de support (15) par rapport au bouchon de fermeture (13).


     
    2. Dispositif (10, 110) selon la revendication 1, le dispositif étant conçu pour infuser les au moins deux liquides de manière successive dans un ordre présélectionné dans le dispositif de réception de liquides (C).
     
    3. Dispositif (10, 110) selon la revendication 2, dans lequel l'un desdits liquides respectifs est un liquide physiologique et un autre est un anticoagulant, et le liquide physiologique est infusé en premier et l'anticoagulant est infusé ensuite.
     
    4. Dispositif (10) selon la revendication 2, dans lequel la structure de support (15) définit une chambre (19) contenant les au moins deux compartiments (11, 12), et les au moins deux compartiments sont alignés en série sur un premier compartiment (11) qui est distal vis-à-vis du second compartiment (12).
     
    5. Dispositif (10) selon la revendication 4, le dispositif (10) comprenant un seul piston (16) qui définit une extrémité proximale du second compartiment (12), la paroi distale (21) de la structure de support (15) définissant une paroi distale du premier compartiment (11), et une cloison mobile (20) séparant les premier et second compartiments (11, 12), tout ceci de telle sorte que l'activation du piston applique une pression au liquide dans le second compartiment provoquant un déplacement distal de la cloison mobile (20) qui met le liquide dans le premier compartiment sous pression de sorte qu'il soit exprimé à travers le conduit (17) afin de sortir de la chambre (19) pour pénétrer dans le dispositif de réception de liquides (C).
     
    6. Dispositif (10) selon la revendication 5, dans lequel la cloison mobile (20) comprend une partie perforable (23) et la paroi distale (21) comprend une partie de perforation (24, 25) faisant saillie en direction de la cloison mobile (20) dans l'alignement de la partie perforable (23), de telle sorte que, lors de l'expression du liquide se trouvant dans le premier compartiment (11) à partir de celui-ci, la cloison mobile (20) se déplace de façon à venir en appui contre la paroi distale (21) de telle sorte que la partie de perforation (24, 25) perfore la partie perforable (23), de façon à établir ainsi une ouverture de sortie par laquelle le liquide se trouvant dans le second compartiment (12) sort de la structure de support (15) à travers le conduit (17) afin de pénétrer dans le dispositif de réception de liquides (C).
     
    7. Dispositif (10, 110) selon la revendication 1, dans lequel la paroi distale (21, 121) comprend une aiguille (22, 122) fixée à celle-ci, disposée dans le conduit (17) et faisant saillie dans la direction distale à partir de celle-ci sur une courte distance afin de pénétrer la membrane transversale refermable (31) du bouchon de fermeture (13) de manière à établir une communication fluidique entre le dispositif et le dispositif de réception de liquides (C), une pointe distale de l'aiguille (22, 122) restant en renfoncement à l'intérieur de l'extrémité distale de la structure de support (15).
     
    8. Dispositif (10, 110) selon la revendication 1, le dispositif comprenant en outre une section de mesure (32) servant à ajuster une quantité d'au moins un des liquides respectifs dans un des compartiments (11, 12 ; 111, 112).
     
    9. Dispositif (10) selon la revendication 8, dans lequel la section de mesure (32) comprend une bague taraudée (33) vissée sur l'extrémité proximale d'un dit piston (16), la bague définissant une limite de course ajustable (34) pour le piston (16) par mise en butée contre une extrémité proximale de la structure de support (15), des références graphiques (35) qui indiquent la quantité de liquide qui peut être infusée étant disposées sur la bague et le piston, et la bague (33) pouvant être tournée de manière sélective afin de sélectionner la quantité de liquide souhaitée, la bague élevant et abaissant la limite de course (34) du piston d'une distance associée à la quantité sélectionnée indiquée par les références graphiques (35), ce qui limite alors la quantité de liquide exprimé à partir dudit compartiment (11, 12).
     
    10. Dispositif (110) selon la revendication 1, dans lequel la structure de support définit une chambre (19) contenant les au moins deux compartiments (111,112), et les au moins deux compartiments sont alignés en parallèle, chaque compartiment comportant un piston respectif (116a, 116b) pour exprimer un liquide à partir de celui-ci, et la structure de support assurant un accès commun au conduit de sorte que le liquide provenant de chaque compartiment (111, 112) sorte du dispositif (110) afin de pénétrer dans le dispositif de réception de liquides (C).
     




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    REFERENCES CITED IN THE DESCRIPTION



    This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

    Patent documents cited in the description