DEVICE FOR CONNECTING A VIAL TO A CONTAINER OR TO A FLUID LINE AND TRANSFERRING THE CONTENTS OF A VIAL TO A CONTAINER OR A FLUID LINE AS WELL AS A METHOD FOR DOING SO AND USE OF SUCH A DEVICE

Abstract

The invention relates to a device and a method for connecting a vial [1] to a container or to a fluid line and transferring the contents of a vial [1] to a container or to a fluid line, wherein the device has a first holder [4] which is suitable for accommodating a connecting device [8], a second holder [5] which is suitable for accommodating a vial [1], an actuating means [7] and a connecting device [8] which consists of an annular housing [13], an inside part [12] having at least one puncture device [14] and a tube connection [16], wherein the annular housing [13] of the connecting device [8] can be constructed to be rotatable about the inside part [12] in the function of a valve, so that by rotation of the housing [13] the flow paths of the connecting device [8] can be opened and closed.

Claims

1. A device for connecting a vial [2] [sic; [1]] to a container or to a fluid line and transferring the contents of a vial [1] to a container or to a fluid line, wherein the device has a first holder [4] which is suitable for accommodating a connecting device [8], a second holder [5], which is suitable for accommodating a vial [1], an actuating means [7] and a connecting device [8] which consists of an annular housing [13], an inside part [12] having at least one puncture device [14] and a tube connection [16], characterized in that the annular housing [13] of the connecting device [8] can be constructed to be rotatable about the inside part [12] in the function of a valve, so that the flow paths of the connecting device [8] can be opened and closed by rotation of the housing [13].

2. The device according to claim 1, characterized in that the actuating means [7] is connected to a lift rod [9] to which the second holder [5] is attached.

3. The device according to claim 1, characterized in that the first holder [4] has a rotary disk [6].

4. The device according to claim 1, characterized in that the rotary disk [6] has at least one undercut [6′] and catch noses [6″] for accommodating the connecting device [8], wherein these are secured by the undercut [6′] in the vertical direction and by the catch noses [6″] in the horizontal direction.

5. The device according to claim 1, characterized in that when the vial [1] is connected the inside part [12] is secured mechanically by the second holder [5] in its starting position.

6. The device according to claim 1, characterized in that an adjusting element [10] secures the rotary disk [6] when the vial [1] is disconnected and thus prevents the housing [13] from rotating, and when the vial [1] is connected and the connecting device [8] is open, it secures the lift rod [9] and thus prevents the vial [1] and the connecting device [8] from being separated.

7. The device according to claim 1, characterized in that the connecting device [8] has a gasket [17] with at least one valve.

8. A method for connecting a vial [1] to a container or to a fluid line and transferring the contents of the vial [1] into a container or a fluid line, wherein the device has a first holder [4] for a connecting device [8], a second holder [5] for a vial [1] and actuating means [7], characterized in that the method comprises the following steps: catch engagement of the connecting device [8] in the first holder [4] provided for this purpose, catch engagement of the vial [1] in the second holder [5] provided for this purpose, combining the vial [1] and the connecting device [8] by activating the actuating means [7], wherein the puncture device [14] punctures the septum of the vial [1], opening the flow path by rotation of the housing [13] of the connecting device [8] about the inside part [12]; closing the flow path through rotation of the housing [13] of the connecting device [8] about the inside part [12]; activating the actuating lever [7] for disconnecting the vial [1] and the connecting device [8]; and removing the vial [1] from the second holder [5] and the connecting device [8] from the first holder [4].

9. The method according to claim 7, characterized in that in bringing the vial [1] and the connecting device [8] together, the actuating means [7] move the lift rod [9] with the second holder [5] and the vial [1] in an axis X toward the connecting device [8].

10. The method according to claim 1, characterized in that when opening the flow path by rotation of the housing [13], the rotary disk [6] accommodating the same also rotates, and the inside part [12] remains in its starting position, due to the form-fitting connection with the second holder [5].

11. A tube set or cassette set having a device according to claim 1.

12. A medical technical treatment unit, in particular an infusion device or an extracorporeal treatment unit, preferably a hemodialysis machine with a device according to claim 1.

13. Use of a device according to claim 1 in a medical technical method, in particular in a method for infusion or extracorporeal treatment, preferably in a hemodialysis process.

14. An evaluation unit for a device according to claim 1, characterized in that it detects the position of the vial [1] and/or of the connecting device [8] and/or the opening of the connecting device [8] by at least one sensor [31].

Description

DRAWINGS, EXEMPLARY EMBODIMENTS—CORRELATION WITH CLAIMS

[0049] The invention will be explained in greater detail below with reference to the drawings, which show:

[0050] FIG. 1: a simplified schematic diagram of the structure of an infusion device having the apparatus according to the invention;

[0051] FIG. 2: a simplified schematic diagram of the structure of an extracorporeal treatment device having the apparatus according to the invention on the example of a hemodialysis machine;

[0052] FIG. 3: a three-dimensional diagram of the apparatus according to the invention;

[0053] FIG. 4a: a three-dimensional diagram of the connecting device with closed flow paths;

[0054] FIG. 4b: a three-dimensional diagram of the connecting device with closed flow paths in a longitudinal section;

[0055] FIG. 5a: a three-dimensional diagram of the connecting device with open flow paths;

[0056] FIG. 5b: a three-dimensional diagram of the connecting device with open flow paths in a longitudinal section;

[0057] FIG. 6: a three-dimensional diagram of the inside part of the connecting device;

[0058] FIG. 7: a three-dimensional diagram of the gasket of the connecting device;

[0059] FIGS. 7a and b: a three-dimensional diagram of the two halves of the gasket of the connecting device;

[0060] FIG. 8a: a schematic diagram of the inside part of the connecting device with the gasket attached in the closed state;

[0061] FIG. 8b: a schematic diagram of the inside part of the connecting device with the gasket attached in the open state;

[0062] FIG. 9: a view of the housing with the tube connection in a schematic diagram;

[0063] FIG. 10: a schematic diagram of the double-lumen tube;

[0064] FIGS. 11a-d: a three-dimensional diagram of the process steps (starting operation of the apparatus according to the invention) of inserting a standard commercial vial and the connecting device up to the stage of opening the flow paths of the connecting device;

[0065] FIG. 12a: a diagram of the apparatus according to the invention in a longitudinal section with the vial disconnected;

[0066] FIG. 12b: a diagram of the apparatus according to the invention in a longitudinal section with the vial connected;

[0067] FIGS. 13a-c: a diagram of the mechanical features of the apparatus according to the invention in a sectional view during connection of the vial;

[0068] FIG. 14: a three-dimensional diagram of a detail of the apparatus according to the invention.

[0069] FIG. 1 shows a simplified schematic diagram of the structure of an infusion device into which the apparatus according to the invention can be integrated.

[0070] For infusion of a medical solution, a tube set [23], which is connected by a venous access to a patient, is used. The contents of an infusion container [25] flow through a drip chamber [24] with the aid of gravity into the patient or the contents are supplied to the drip chamber by a pump [26]. Injection sites [28] for drugs may be integrated into the tube set. These are suitable for connecting the apparatus according to the invention [2]. Connecting the apparatus according to the invention to the drip chamber [24] is also possible. The apparatus according to the invention may also be designed as an integral part of an infusion tube set.

[0071] FIG. 2 shows a simplified schematic diagram of the structure of an extracorporeal treatment device on the example of a hemodialysis machine into which the apparatus according to the invention can be integrated.

[0072] In hemodialysis, blood is taken from a patient usually through an arterial venous fistula. The part of the extracorporeal circulation upstream from the dialyzer is referred to as the arterial part and the part downstream from the dialyzer is the venous part. In hemodialysis, as with other extracorporeal treatment processes, the extracorporeal circulation usually takes place completely within a tube set or a cassette set [23]. In most cases, a drip chamber [24] is integrated into the venous part of the circulation to eliminate any air bubbles that might be formed. Injection sites [28] for drugs, which are suitable for connecting the apparatus according to the invention [2], are usually also provided in the tube sets and/or in the cassette sets for extracorporeal treatments. As shown in FIG. 2, it is possible to add drugs with the help of the apparatus according to the invention [2] to the arterial part of the extracorporeal circulation [A], to the venous part of the circulation upstream from the drip chamber [B] and downstream from the drip chamber [D] or to add the drugs to the drip chamber itself [C]. The apparatus according to the invention may also be an integral part of a tube set or a cassette set for an extracorporeal treatment, and preferably a hemodialysis tube set or cassette set may be designed that way.

[0073] FIG. 3 shows a three-dimensional diagram of the apparatus according to the invention [2]. It consists of a first holder [4] for accommodating a connecting device [8], a second holder [5] for accommodating a vial [1], and actuating means [7] and a connecting device [8].

[0074] An actuating means [7] is connected to a lift rod [9] to which the second holder [5] is attached. The actuating means [7] can serve to move the lift rod [9] and the second holder [5] in an axis X.

[0075] A rotary disk is integrated [6] into the first holder. The connecting device [8] is secured in same by means of an undercut [6′] so that it is secured in the vertical direction and in the horizontal direction by means of catch noses [6″].

[0076] In one embodiment, the apparatus according to the invention may be permanently integrated into or detachably attached to a medical technical treatment unit, preferably an infusion device or an extracorporeal treatment unit, in particular a hemodialysis machine, by means of a machine holder [3].

[0077] The apparatus may thus be used in a medical technical procedure, in particular in a method for infusion or extracorporeal treatment, preferably in a hemodialysis process.

[0078] It has both rigid elements such as, for example, the connecting device [8] and soft elements such as, for example, the gasket [17]. The rigid material is preferably made of a polymer suitable for this purpose, such as polycarbonate (PC), polypropylene (PP), polyethylene (PE), polystyrene (PS), polyvinylchloride (PVC), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), acrylonitrile-butadiene-styrene (ABS) and copolyester.

[0079] The soft material consists of a suitable elastic material, preferably an elastomer such as, for example, silicone rubber, styrene-ethylene-butylene-styrene (SEBS), styrene-ethylene-propylene-styrene (SEPS), styrene-isoprene-styrene (SIS), styrene-butadiene-styrene (SBS), polyurethane (PU), polyisoprene, thermoplastic elastomer (TPE), natural rubber (NR) and latex.

[0080] FIGS. 4a and 5a show a three-dimensional diagram of the connecting device [8] with both closed and opened flow paths.

[0081] FIGS. 4b and 5b show a three-dimensional diagram of the connecting device [8] with both closed and opened flow paths in a longitudinal section.

[0082] FIGS. 4a/b and 5a/b show that the connecting device [8] consists of an annular housing [13] with an engagement surface [15], an inside part [12] which is also annular, a puncture device [14], a gasket [17] and a tube connection [16].

[0083] The housing [13] of the connecting device [8] is designed so that it can rotate about the inside part [12] in the function of a valve. The housing [13] can be guided securely and easily to the engagement surface [15], i.e., without applying any great force, around the inside part [12] during rotation.

[0084] Since vials [1] are made primarily of a material that is rigid, the volume of the contents transferred when transferring the contents of one vial [1] into a container or into a fluid line must be replaced, so that the flow does not stop. The puncture device [14] of the apparatus according to the invention [2] must therefore have two line paths. A first line path [14′] serves to transfer the contents of the vial [1] into a container or into a fluid line, while a fluid, preferably a gas, can flow into the vial [1] over a second line path [14″]. The contents of the vial [1] flowing out are therefore replaced, which thus prevents the development of a vacuum that would cause the flow to stop. The puncture device [14] may be designed in the form of two separate hollow needles, cannulas or spikes, preferably in the form of a double-lumen spike.

[0085] The connecting device [8] is also designed so that a cover [29] can be placed tightly on the puncture device [14]. It may preferably be made of an elastic material, so that it is compressed in connecting a puncture vial [1] and it releases the puncture device [14], returns back to its starting position in disconnecting and covers the puncture device [14] once again. By tightly covering the puncture device [14], contamination from the environment can be prevented.

[0086] The line paths of the puncture device [14] are continued in the hose connection [16] as the first flow path [16′] for a fluid [1] flowing out of the vial [1] and as the second flow path [16″] for a fluid flowing into the vial [1]. Ideally a double-lumen tube, such as that shown in FIG. 10, may be connected at this point.

[0087] In a three-dimensional diagram of the inside part [12] of the connecting device [8] of the apparatus according to the invention [2], FIG. 6 shows the first flow path [16′] for the contents of the vial [1] and the second flow path [16″] for a fluid flowing into the vial [1] and shows the contours of the gasket [22]. The sealing contours [22] serve to provide a defined seal of the flow paths so that the flow paths are completely surrounded during the rotation of the housing [13] about the inside part [12] in both the opened and closed states of the connecting device [8], thereby ensuring imperviousness.

[0088] FIG. 7 shows a three-dimensional diagram of the gasket [17] of the connecting device [8]. The gasket [17] serves to provide a fluid-tight connection between the inside part [12] and the housing [13].

[0089] In preferred embodiment, as illustrated in a three-dimensional diagram in FIGS. 7a and b, the gasket [17] consists of a first half [17′] and a second half [17″], which are designed to correspond to one another so that each half has a centering hole [18], a centering pin [19] and in a particularly preferred embodiment, a valve seat [20] and valve flap [21]. The type of valves and different possibilities with respect to the embodiment and/or functioning are known from the prior art and are described in detail in particular for use in a device for transferring liquids from vials, for example, in the International Patent Application WO 2011/141200 A1, the content of which is herewith incorporated into the present description, and therefore they will not be explained further at this point.

[0090] The gasket [17] also rotates on the inside part [12] with the rotation of the housing [13]. FIG. 8a shows a schematic diagram of the inside part [12] of the connecting device [8] with the gasket [17] attached, shown in the closed state; FIG. 8b shows a schematic diagram of the inside part [12] of the connecting device [8] with the gasket [17] attached, shown in the open state.

[0091] FIG. 9 shows a view of the housing [13] with the tube connection [16] shown schematically. Ideally the housing [13] has defined connecting contours [30] on the tube connection [16] in a special embodiment in order to conduct fluids flowing in or out through the connecting device [8] in such a manner that a double-lumen tube can be connected independently of its angular position.

[0092] FIGS. 11a-d show a three-dimensional diagram of starting operation of the apparatus according to the invention [2].

[0093] Before starting operation of the apparatus according to the invention [2], the connecting device [8] to which a fluid line or a container is connected is inserted into the rotary disk [6] integrated into the first holder [4]. In doing so the connecting device [8] is secured in its vertical direction by the undercut in the rotary disk [6′] and is secured in the horizontal direction by catch noses [6″].

[0094] FIG. 11a shows the apparatus according to the invention [2] with the connecting device [8] inserted and a standard commercial vial [1] prior to insertion.

[0095] A standard commercial vial [1] consists of a body [1′], a neck [1″] and head [1′″]. The head [1′″] has a closure which may be designed as a stopper or a membrane and is attached to the neck [1″] by a flanged edge.

[0096] The vial [1] is inserted into the apparatus according to the invention [2] where it is pushed into the second holder [5] with its neck [1″], so that the head [1′″] of the vial [1] is directly opposite the connecting device [8]. This is shown in FIG. 11b.

[0097] By moving the actuating means [7] which is connected to the lift rod [9] of the apparatus according to the invention [2], from a first position [34] into a second position [35], as shown in FIG. 11c, the vial [1] is moved in an axis X to the connecting device [8]. In doing so, the septum of the vial [1] is perforated by the puncture device [14], which completely enters the vial [1] when in the second position [34] of the actuating means [7], so that the first line path [14′] and a second line path [14″] open into the interior of the vial [1].

[0098] FIG. 11d shows the opening of the connecting device [8] by rotation of the housing [13] about the inside part [12]. The rotation is preferably by 90° to one side of the apparatus according to the invention [2]. By securing of the connecting device [8] by catch engagement of the housing [13] in the undercut [6′] and the catch noses [6″] of the rotary disk [6], the latter is also moved in the rotation of the housing [13]. The inside part [12] abuts against the second holder [5] and/or together with it forms a form-fitting closure and is thus secured in its starting position.

[0099] The rotation of the rotary disk [6] has two effects: first it reliably prevents removal of the opened connecting device [8] and secondly the connecting device [8] is secured in its vertical position.

[0100] By rotating the housing [13] about the inside part [12] back into its central starting position, the connecting device [8] is closed again. The rotary disk [6] also rotates back into its starting position in synchronization with the housing [13].

[0101] If the transfer of the contents of the vial [1] is to be terminated, the actuating means [7] is moved back from the second position [35] into the first position [34]. The lift rod [9] of the apparatus according to the invention [2], to which the second holder [5] is attached, moves together with it and separates the vial [1] and the connecting device [8] from one another. The two parts can then be removed.

[0102] In another embodiment, it is conceivable for the vial [1] and the connecting device [8] to be removed in the connected state when the connecting device [8] is closed. This permits a faster and more convenient dismantling of the apparatus according to the invention [2] after it has been used.

[0103] Determined by the interaction of the individual components, the device according to the invention [2] can be operated exclusively in a defined sequence of individual steps. Thus, for example, the opening and closing of the flow paths of the connecting device [8] are possible only if a vial has been inserted. Removal of the vial [1] is in turn possible only when the connecting device [8] is in the closed position.

[0104] Insertion of the vial [1] and the connecting device [8] into the apparatus according to the invention [2], combining all the parts by activation of the actuating means [7] and opening and/or closing the connecting device [8] are all actions that can be performed with one hand.

[0105] FIG. 12a shows the apparatus according to the invention in a longitudinal section with the vial [1] disconnected and with the connecting device [8] closed. If the actuating means [7] is in its first position [34], an adjusting element [10] secures the rotary disk [6]. Unintentional rotation of the rotary disk [6] and thus of the housing [13] of the connecting device [8] is thus prevented.

[0106] FIG. 12b shows an apparatus according to the invention in a longitudinal section with the vial connected and the connecting device [8] opened. If the actuating means [7] is in its second position [35], then an adjusting element [10] secures the lifting rod [9]. This prevents unintentional separation of the vial [1] from the connecting device [8].

[0107] The adjusting element thus supports holding of the vial and the connecting device tightly, securely and accurately.

[0108] FIG. 13a-c shows the individual steps of the mechanical aspects of the apparatus according to the invention in multiple sectional views during the connection of a vial.

[0109] A mechanical translation takes place in the interior of the apparatus according to the invention [2], for example, in the form of a toggle lever [11] or a gearwheel, which serves to transmit the force. This greatly reduces the force to be expended by the personnel in bringing the vial [1] and the connecting device [8] together, i.e., to 50N in the individual case, and handling is facilitated.

[0110] FIG. 14 shows in a detail of the apparatus according to the invention [2] a sensor [31], for example, a Hall sensor which detects the position of the connecting device [8] by means of a magnet [33]. In a particular embodiment, the apparatus according to the invention has an evaluation unit [32] as the external additional device or is integrated into the dialysis machine which recognizes the position of the vial [1] by means of at least one sensor [31] and/or the position of the connecting device [8] and/or the opening of the connecting device [8] and can provide an acknowledgement to the dialysis machine or to the user, if needed.

[0111] However, it is also conceivable that there is an indication of whether the connecting device [8] is opened or closed by means of a window in the housing of the connecting device [8], which enables a view to an optical character on the inside part [12], for example, a color or a symbol, depending on the position of the housing [13]. [0112] 1 vial [0113] 1′ body of the vial [0114] 1″ neck of the vial [0115] 1′″ head of the vial [0116] 2 device for connecting a vial [0117] 3 machine holder [0118] 4 first holder [0119] 5 second holder [0120] 6 rotary disk [0121] 6′ undercut [0122] 6″ catch noses [0123] 7 actuating means [0124] 8 connecting device [0125] 9 lift rod [0126] 10 adjusting element [0127] 11 toggle lever [0128] 12 inside part of the connecting device [0129] 13 housing of the connecting device [0130] 14 puncture device [0131] 14′ first line path [0132] 14″ second line path [0133] 15 engagement surface [0134] 16 tube connection [0135] 16′ flow path for contents of vial [0136] 16″ flow path for fluid [0137] 17 gasket [0138] 17′ first half of gasket [0139] 17″ second half of gasket [0140] 18 centering hole [0141] 19 centering pin [0142] 20 valve seat [0143] 21 valve flap [0144] 22 sealing contours [0145] 23 tube set [0146] 24 drip chamber [0147] 25 infusion container [0148] 26 pump [0149] 27 dialyzer [0150] 28 injection site [0151] 29 cover [0152] 30 connecting contours [0153] 31 sensor [0154] 32 evaluation unit [0155] 33 magnet [0156] 34 first position of the actuating means [0157] 35 second position of the actuating means [0158] A feed point for the arterial leg [0159] B feed point for the arterial leg [0160] C feed point for the drip chamber [0161] D feed point for the venous leg