Device for introducing medicine into an infusion container

A device for adding a medicine to an infusion solution in an infusion container having a removal opening provided with a seal area. A transfer cap, which has a first hollow spike for piercing the seal area, is connected to the removal opening of the infusion container. A receiving means for a medicine container is formed at the transfer cap, which has a second hollow spike for piercing a seal at the medicine container. A valve is arranged between the first and second hollow spikes in the transfer cap, where the valve interrupts the connection between the first and second hollow spikes and can be moved into the open position by the action of a force.

This is a U.S. national phase application under 35 U.S.C. §371 of International Patent Application No. PCT/EP2008/008283, filed Sep. 30, 2008, and claims the benefit of priority to German patent application DE 10 2007 046 951.0 filed Oct. 1, 2007, the contents of each of which are expressly incorporated herein by reference as if set forth in full.

BACKGROUND

The present disclosure relates to a device for introducing a medicine into an infusion container, which is provided with a sealed removal opening.

2. Related Art

Before an infusion set with a drip chamber is attached to an infusion container for carrying out an intravenous infusion, it is known to add a medicine to the infusion solution. Generally, a medicine container, having a transfer cap with a hollow spike used for piercing a seal at the infusion container is attached to the removal opening of the infusion container, which also has a receiving means for the medicine container.

After connecting the infusion container to the medicine container, infusion solution is displaced into the medicine container by repeatedly compressing and releasing the flexible infusion container. After dissolving and adding medicine to the infusion solution, the arrangement is rotated such that the infusion container is situated below and the medicine container above, whereupon the contents of the medicine container are drawn by suction back into the infusion container by again repeatedly compressing and releasing the flexible infusion container. Next, the medicine container having the transfer cap is removed from the infusion container and the infusion set is attached to the infusion container, whereupon the infusion can begin.

This procedure is associated with the risk of contamination of the infusion solution because after removing the medicine container, the removal opening of the infusion container is exposed and contaminating ambient air can enter the infusion container.

SUMMARY

The present disclosure provides a device and associated method for adding medicine to the infusion solution in the infusion container while reducing the risk of contamination.

This object is solved according to the invention by the features of claim1. However, the invention is not limited to the features of claim1for various aspects of the invention are disclosed throughout the specification and are depicted in the appended drawings. The medicine container is not released from the transfer cap after adding the medicine to the infusion solution, thus allowing the infusion to be carried out while the medicine container is at the infusion container. Thus, the system of the present disclosure for infusing medicine into the infusion solution is maintained in a closed state, thus reducing the risk of contamination of the infusion solution.

In one aspect, a device is provided for adding a medicine to an infusion solution in an infusion container having a removal opening provided with a seal area. The device includes a transfer cap connectable to the removal opening of the infusion container, where the transfer cap has a first hollow spike configured for piercing the seal area. A receiving means is provided for a medicine container formed on the transfer cap, where the receiving means has a second hollow spike configured for piercing a seal of the medicine container. The device also includes a valve arranged between the first and second hollow spikes in the transfer cap, where the valve interrupts the connection between the first and second hollow spikes and where the valve can be moved into an open position only by the action of a force.

In another aspect, a device is provided for adding a medicine to an infusion solution, which includes a hollow cylindrical member including a first hollow spike configured for piercing a seal area on a removable opening. The device also includes a tubular hub coupled to the hollow cylindrical member and configured to receive a container in a locking arrangement. The tubular hub includes a second hollow spike configured for piercing a seal of the container. A valve is positioned between the first and second hollow spikes, where the valve is manipulatable by the action of a force to open the valve and allow flow between the first hollow spike and the second hollow spike.

In yet another aspect, a method is provided for adding a medicine to an infusion solution in an infusion container having a removal opening provided with a seal area. The method comprises coupling a hollow cylindrical member including a first hollow spike and piercing the seal area on the removable opening; coupling a tubular hub including a second hollow spike to a medicine container in a locking arrangement, and piercing a seal of the medicine container; and actuating a valve positioned between the first and second hollow spikes to open the valve and allow a flow through the first hollow spike and the second hollow spike from between the infusion container and the medicine container.

An advantage of the present infusion set is simplified handling and increased safety since it is no longer necessary to remove the medicine container from the infusion container which allows the health care worker to read at any time which medicine has been added to the infusion solution by reference to the medicine container.

DETAILED DESCRIPTION

The detailed description set forth below in connection with the appended drawings is intended as a description of the presently preferred embodiments of a device for adding medicine to an infusion container or transfer device and is not intended to represent the only forms in which the present device, system, and method may be constructed or used. The description sets forth the features and the steps for constructing and using the transfer device of the present disclosed embodiments in connection with the illustrated figures and examples. It is to be understood, however, that the same or equivalent functions and structures may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the invention. As denoted elsewhere herein, like element numbers are intended to indicate like or similar elements or features.

FIG. 1shows a perspective view of an infusion set100having, an infusion container1coupled to a medicine container3and a drip chamber4in a ready state for carrying out an infusion.FIG. 1shows the bottle-shaped infusion container1as generally comprising a transparent synthetic material having flexible wall portions. The flexible wall portions of the infusion container1may be compressed and released for generating pressure in the infusion container1, whereupon on release thereof, low pressure is generated due to the flexible wall portions returning to their original position. A loop1.1for suspending the infusion container1may be provided on the upper side of the infusion container1. On the lower or opposing side, the infusion container1is provided with a bottleneck1.2to which a transfer cap2may be attached. The medicine container3, usually made of glass or similar material, is inserted in the transfer cap2with its axis inclined to the axis of the infusion container1. The drip chamber4of the infusion set may be connected to the infusion container1.

FIG. 1shows an embodiment of the operating position of the infusion set in which an infusion may be carried out, where the drip chamber4is arranged with its axis essentially parallel or vertical (not inclined) to the axis of the infusion container1. In other embodiments, the drip chamber4is inclined or is parallel but offset.

FIG. 2shows a cross sectional view of an embodiment of the transfer cap2in the operating position shown inFIG. 1. As shown inFIG. 2, a sealing cap1.3having a piercable seal area1.4is attached to the bottleneck1.2of the infusion container1in a liquid-impermeable manner, such as in a liquid tight seal. The transfer cap2with the bottleneck1.2having the seal cap1.3may be fixed at a flange portion (FIG. 1) by means of resilient locking portions2.1, which releasably overlap the edge of the seal cap1.3. Attached to the flange portion is a hollow cylindrical portion2.2of the transfer cap2. As shown inFIG. 2, a tubular hub2.3is formed eccentrically such that the axis B thereof lies inclined to the axis A of the bottleneck1.2of the infusion container1. The tubular hub2.3forms a receiving means for receiving a bottleneck3.1of the medicine container3. The medicine container bottleneck3.1is provided with a flange or an enlarged cap section2.50, which engages resilient hooks or detents2.31provided on the circumference of the tubular hub2.3. The engagement between the flange2.50and the detents2.31locks the medicine container3in the connected position to the infusion container1. Thus, an aspect of the present transfer device is a transfer cap comprising a first receiving end for receiving an infusion container and a second receiving end for receiving a medicine container, and wherein the first receiving end and the second receiving end engage the infusion container and the medicine container such that an axis of the medicine container is inclined relative to an axis of the infusion container. In another example, the infusion cap holds the infusion container and the medicine container such that a base end of the infusion container and a base end of the medicine container both face outwardly away from the first and second receiving ends.

In the area of the tubular hub2.3, the transfer cap2is provided with a first hollow spike2.4on a side facing the infusion container1. The first hollow spike2.4pierces the seal area1.4of the seal cap1.3when the transfer cap2is attached to the bottleneck1.2of the infusion container1. A second hollow spike2.5is arranged at the transfer cap2such that it pierces a seal3.2of the medicine container3when the medicine container3is inserted into the tubular hub2.3.

Thus, the transfer cap2allows the user to couple the hollow cylindrical portion2.2to the bottleneck2.1of the infusion container1while allowing the tubular hub2.3to be connected to a different container, such as the medicine container3. The tubular hub2.3is arranged at an angle or inclined to the axis of the hollow cylindrical portion or member2.2. The two parts may be locked together to form a single transfer cap2or may be made, either by moulding or casting, as a solid unitary member. The first hollow spike2.4is arranged substantially parallel to the axis of the hollow cylindrical portion2.2such that the piercing end of the first hollow spike2.4points to a seal area of the infusion container1when being coupled thereto. The second hollow spike2.5is arranged substantially parallel to the axis of the tubular hub2.3such that the piercing end of the second hollow spike2.5points to a seal on the medicine container3when being coupled thereto. In one embodiment, since the hollow cylindrical member2.2and the tubular hub2.3are arranged inclined to one another, the first and second hollow spikes are also arranged inclined to one another.

Between the first hollow spike2.4and the second hollow spike2.5in the transfer cap2is a valve5positioned to interrupt or block the connection between the first and second hollow spikes2.4and2.5. In one embodiment, the valve opens to unblock the connection between the two hollow spikes only under the action of an actuating force. The actuating force may include the pressure created when compressing the infusion container either by manual manipulation or by using an automated process. Thus, actuating the valve positioned between the first and second hollow spikes causes the valve to open and allow a flow of liquid, such as a medication, through the first hollow spike2.4and the second hollow spike2.5from between the infusion container1and the medicine container3.

In the embodiment shown inFIG. 2, the valve is formed as a resilient valve disc5, which has three radial slits5.1in its middle area. The valve disc5is clamped on the circumference between two opposing sets of annular shoulders. The first set of annular shoulders is formed at a partition wall2.7of the transfer cap2upon which the first hollow spike2.4is moulded. The second opposing set of annular shoulders is formed at the flange of a member provided with the second hollow spike2.5, which in this embodiment is inserted as a separate component part into the transfer cap2or in the area of the partition wall2.7. It should be understood that the valve disc5may be clamped or held between the first and second hollow spikes2.4and2.5in any suitable manner that allows for the valve to operate or interrupt or block the flow of fluid through the first and second hollow spikes2.4and2.5and between the infusion container1and the medicine container3. In another example, the valve is spring loaded and opens when an external force is applied but automatically closes when the external force drops below a certain minimum threshold, i.e., below the spring force.

Laterally, adjacent the eccentric inclined tubular hub2.3, the transfer cap2is provided with a recess2.6(FIG. 1) through which the seal area1.4of the seal cap1.3is exposed to allow the infusion set having a hollow spike4.1at the drip chamber4to be inserted vertically by piercing the hollow spike4.1into the seal area1.4through the recess2.6.

In the operating position shown inFIG. 2, infusion solution from the infusion container1can flow through the hollow spike4.1into the drip chamber4while the valve disc5maintains the connection between infusion container1and medicine container3in a closed state.

In one embodiment, to add medicine to the infusion solution, the transfer cap2having the tubular hub2.3is first attached to the neck3.1of the medicine container3, causing the second hollow spike2.5to pierce the seal3.2of the medicine container. In this embodiment, the transfer cap2is connected to the medicine container3in such a manner that the medicine container3cannot be detached from the transfer cap2without a tool. Once connected, as shown inFIG. 2a, the transfer cap2with the medicine container3is attached to the sealed infusion container1, causing the first hollow spike2.4to pierce the seal area1.4of the infusion container. In one embodiment, the infusion container1can be positioned with the bottleneck located upwards and its base downwards so that the transfer cap2and the medicine container3are attached to the infusion container1from above. The closed valve5prevents leakage from the medicine container3so that its outlet can face the ground without spilling during the mounting process.

After installing the transfer cap2with the medicine container3to the infusion container1in the manner described above, the assembly is rotated 180° to correspond to the position shown inFIG. 2a. By repeatedly compressing the flexible walls of the infusion container1, infusion solution is displaced into the medicine container3. Due to the pressure exerted on the infusion container1, the valve disc5opens by means of the valve lips located between the slits5.1. The valve lips bend to allow the passage of infusion fluid into the medicine container3. Thus, an exemplary method discussed herein is understood to include adding an infusion solution into a medicine container by piercing a first seal, piercing a second seal, and squeezing a container wall of an infusion container to force liquid into the medicine container. In a further example, a valve disc is forced to flap or swing open by pressure generated in squeezing the container wall, which allows fluid communication between the infusion container and the medicine container. In yet another example, the infusion container and the medicine container are first rotated before the squeezing step.

After dissolving and mixing the medicine and the infusion fluid in the medicine container3, the arrangement is rotated vertically by 180° into the position shown inFIG. 2b. Again, by repeated compression of the infusion container1, the medicine added to the infusion solution is drawn by suction from the medicine container3into the infusion container1. In this case, the valve disc5opens due to the low pressure generated in the infusion container1after release of the compressed side walls of the infusion container1. Thus, another embodiment disclosed herein is understood to include a method for mixing fluids in which a second rotation step is performed follow by further squeezing of the infusion container wall. On a broader level, examples discussed herein include passing fluid back and forth between two different containers prior to infusing a patient. In the specific examples discussed, the passing of fluid comprises piercing two different container seals with two different spikes that are in fluid communication with one another. To regulate the passing of fluid, a valve is provided between the two spikes. In one example, the valve may be actuated by pressure or by creating a differential pressure situation to force fluid to flow from a relatively higher pressure region to a relatively lower pressure region.

After the contents of the medicine container3have been transferred into the infusion container1, which includes the original undiluted medicine contents as well as some of the infusion fluids, the hollow spike4.1of the drip chamber4is inserted by piercing into the seal area1.4of the infusion container1through the recess2.6in the transfer cap2, whereupon the infusion can begin in the position shown inFIG. 1. In this position, the connection between the medicine container3and the infusion container1is interrupted by the valve disc5, because no force is acting on the valve disc5. Thus, no infusion fluid can flow back into the medicine container3located below the valve disc5. The medicine container3is not releasably connected to the transfer cap2and remains in the position at the transfer cap2shown inFIGS. 1 and 2while the infusion is being carried out. In one example, the entire contents of the medicine container3are drained into the infusion container before the drip chamber4is connected to the transfer cap2. In another example, less than the entire contents of the medicine container3are drained before the drip chamber4is connected. Thus, a further feature of the present device, system, and method for transferring fluid includes transferring fluid from a first container into a second container, transferring fluid from the second container back to the first container, and then transferring fluid from the first container through a drip chamber for infusing a patient.

Since the medicine container3remains connected to the infusion container1during an infusion procedure, the medicine added to the infusion solution is immediately recognizable to operating personnel. Moreover, since the medicine container3is not released from the infusion container1or the transfer cap2after the mixing process, no contamination can occur in the connecting area between the medicine container3and the infusion container1. After attaching the medicine container3to the infusion container1, the system is maintained in a closed state. Thus, on a broader level, a feature of the present device, system, and method is a provision for blending medicine with infusion fluid using a transfer cap and wherein the cap retains the medicine container for at least part of the infusion process, and more preferably for the entire infusion process, for purposes of identifying contents of the infusion fluid and/or the medicine used for the infusion procedure.

The valve disc5makes it unnecessary to remove the medicine container3arranged in the transfer cap2between the first and second hollow spikes2.4and2.5, which are arranged inclined to each other and separate from each other, allowing the valve disc5to be embodied in various ways.

FIG. 3shows a cross sectional view through the device having a valve disc which may be actuated by rotation in accordance with an embodiment. In this embodiment, a valve disc6is moulded at the second hollow spike2.5, and is held twistably or rotatably between detents at the partition wall2.7of the transfer cap2. The valve disc6is provided eccentrically with a through-channel6.1, which can be aligned with the mouth opening of the first hollow spike2.4.FIG. 3shows the closed position of the valve disc6, in which a closed area of the valve disc6is located opposite the mouth opening of the first hollow spike2.4.FIG. 3ashows the connected position of the valve disc6, in which the through-channel6.1is aligned with the first hollow spike2.4.

To allow the valve disc6with the second hollow spike2.5moulded thereon to be twisted or rotated, a form fit is expediently formed between the seal3.2and the second hollow spike2.5by the second hollow spike2.5having, for example, an oval cross section. In this embodiment, by twisting the medicine container3in the tubular hub2.3, the valve disc6can also be twisted into the open or closed position. Thus, when using the present embodiment, another rotational step is included, which is the rotational step of the valve. This rotational step is in addition to rotation the containers discussed above.

FIG. 4shows a cross sectional view through the device having a valve member7which is displaceable in the axial direction of the tubular hub2.3in accordance with an embodiment. In this embodiment, a hub2.51is moulded on at the second hollow spike2.5and has a through-channel2.52(FIG. 4a) that can be sealed and unblocked by the displaceable valve member7.FIG. 4shows the closed position andFIG. 4athe open position, in which the sleeve-shaped valve member7is displaced toward the medicine container3so that the through-channel2.52is unblocked.

FIG. 5shows a cross sectional view through the device having a valve with a twistable valve body and having an adjusting knob protruding from the transfer cap in accordance with an embodiment. In this embodiment, the valve is positioned between the first and second hollow spikes2.4and2.5arranged inclined to each other in the transfer cap2, which has a twistable valve body8having an adjusting knob8.1protruding from the transfer cap2. The shaft-shaped valve body8can be twisted in across-hole of a hub at the second hollow spike2.5. The valve body8is provided with a through hole8.2, which can be aligned with the second hollow spike2.5and a connecting opening to the first hollow spike2.4when the adjusting knob8.1is rotated into the open position denoted by a reference8.11as shown inFIG. 5a.

In the embodiments described, the medicine container3is set inclined to the vertical in the operating position at the transfer cap2so that the flow path between the first and second hollow spikes2.4and2.5is kept as minimal as possible. However, in an alternative embodiment, the transfer cap2may be made wider on the side of the medicine container3, so that the medicine container3can likewise be positioned approximately vertically, that is, with its axis B approximately parallel to the axis A of the infusion container1. Although this results in a longer flow path between the first and second hollow spikes2.4and2.5with the interposed valve, the flow path can be configured such that no disruptions occur during the mixing of the medicine.

In such an embodiment, a valve member can be provided between the first and second hollow spikes2.4and2.5, which is displaceable transverse to the axes A and B of the infusion container1and of the medicine container3, for opening and closing the connection between the two containers in the transfer cap2.

FIGS. 6a,6band6cshow perspective representations of the transfer cap2in accordance with an embodiment. In this embodiment, the second hollow spike2.5is formed as a separate component part, which is inserted at the partition wall2.7(FIG. 6c), not shown inFIGS. 6band6c.

In one embodiment, the transfer cap2may be formed in two parts such that the tubular hub2.3is attached to the hollow cylindrical portion2.2by means of detents, which simplifies the manufacture of the transfer cap2.FIGS. 8 and 9show a two-part embodiment of the transfer cap2. As shown inFIG. 9, detent recesses2.32are formed at diametrically opposite positions at the lower edge of the tubular hub2.3. The detent recesses2.32correspond to detent projections2.33formed at the upper circumference of the hollow cylindrical portions2.2when the tubular hub2.3is attached to the portion2.2.

In this embodiment as shown inFIGS. 8 and 9, the first and second hollow spikes2.4and2.5are moulded onto the hollow cylindrical portion2.2and the tubular hub2.3of the transfer cap2. The second hollow spike2.5is moulded on at a partition wall2.51in the tubular hub2.3such that a chamber2.52is created between the second hollow spike2.5and the valve5. Detent recesses2.32shown inFIG. 9are formed at the edge portion, denoted by2.34inFIG. 8, of the tubular hub2.3.

As shown inFIG. 2, at the hollow cylindrical portion2.2, the first hollow spike2.4is moulded on in a corresponding way at the partition wall2.7, wherein the chamber2.71abutting at the valve disc5is formed larger inFIG. 8than inFIG. 2.

The valve in the form of the valve disc5is clamped between the partition wall2.7of the hollow cylindrical portion2.2and the partition wall2.51of the tubular hub2.3.

In the embodiment ofFIGS. 8 and 9, the detents2.31, as described in reference toFIG. 2, for receiving the medicine container3, are formed as detent hooks formed at opposite positions on the circumference of the tubular hub2.3in this embodiment. At the hollow cylindrical portion2.2, in place of the opposite detent portions2.1, as described in reference to6b, as shown inFIGS. 8 and 9adjacent detent portions are formed such that altogether four detent portions2.1result.

In another embodiment, the first and second hollow spikes2.4and2.5are moulded on at the transfer cap2or at the partition wall2.7thereof, where the valve mechanism can be inserted laterally between the first and second hollow spikes, in a manner similar to the configuration shown inFIG. 5.

In one embodiment, the seal area1.4at the removal opening of the infusion container1can be configured such that there are two adjacent seal openings1.41and1.42in the cap1.3, one of which is provided for the first hollow spike2.4of the transfer cap2and the other of which is provided for the hollow spike4.1of the drip chamber4.FIG. 7shows an approximately rectangular seal area1.4configured in such a manner at the infusion container1, where the border of the rectangular seal area1.4is a part of the seal cap1.3.

In this embodiment of the seal area1.4, an aligning means can be moulded on at the transfer cap2. Using the aligning means, the transfer cap2can be attached to the infusion container1or to the seal cap1.3only in such a manner that one of the openings1.41and1.42is located under the recess2.6and the other is located under the first hollow spike2.4of the transfer cap. In this way, incorrect positioning of the transfer cap2on the seal cap1.3is prevented.

In the embodiments described above, for example inFIG. 1, the medicine container3and the drip chamber4are arranged such that their axes lie essentially in one plane. In an alternative embodiment, the medicine container3and the tubular hub2.3are arranged inclined to the plane of the drawing inFIG. 1so that in a right or a left side view inFIG. 2the medicine container3lies inclined to the drip chamber4or inclined to the plane of the drawing inFIG. 2.

Although the present invention has been described with reference to specific embodiments, these embodiments are illustrative only and not limiting. Many other applications and embodiments will be apparent in light of this disclosure and the following claims.