Container for a medical liquid
11013663 · 2021-05-25
Assignee
Inventors
- Torsten Brandenburger (Reichelsheim, DE)
- Ismael Rahimy (Friedberg, DE)
- Christian Frensch (Hofheim, DE)
Cpc classification
A61M2039/1033
HUMAN NECESSITIES
A61M39/26
HUMAN NECESSITIES
A61M39/20
HUMAN NECESSITIES
A61J1/2096
HUMAN NECESSITIES
International classification
A61J1/20
HUMAN NECESSITIES
A61M39/26
HUMAN NECESSITIES
Abstract
A container for a medical liquid, comprising a connection piece via which a medical liquid can be pumped into or out of the container, an attachment part which can be attached to the connection piece and connected to a pump device to pump a medical liquid or out of the container, and a sealing element for sealing a passage between the connection piece and the attachment part. The sealing element has a slot opening which is closed against a liquid flow when the pump device is not attached to the attachment part and which is open when the pump device is attached to the attachment part such that a medical liquid can be pumped through the slot opening. The attachment part has a connection portion with an opening into which the connection piece can be inserted along an insertion direction in order to connect to the attachment part.
Claims
1. A container for a medical liquid, the container having a connection piece by means of which a medical liquid is conveyable into the container or out of the container, an attachment part that is attachable to the connection piece and is connectable to a conveying device for conveying a medical liquid into the container or out of the container, and a sealing element for sealing a transition between the connection piece and the attachment part, wherein the sealing element comprises a slot opening that, with the conveying device not attached to the attachment part, is closed against a passage of liquid and, as a result of attaching the conveying device to the attachment part, is to be opened in such a manner that a medical liquid is conveyable through the slot opening, wherein the attachment part comprises a connecting portion with an opening into which the connection piece is insertable along an insertion direction for connection to the attachment part and the opening comprises a first receiving portion and a second receiving portion that connects axially thereto along the insertion direction, wherein, with the attachment part attached to the connection piece, the first receiving portion receives a head of the connection piece and the second receiving portion receives a portion of the sealing element, wherein the first receiving portion comprises a first diameter and the second receiving portion comprises a second diameter, wherein the first diameter is smaller than the second diameter and the sealing element, with the conveying device not attached to the attachment part, is received in the second receiving portion with radial play, wherein the sealing element comprises a sealing head and a cylindrical body, and wherein the cylindrical body is not clamped by the attachment part.
2. The container as claimed in claim 1, wherein the sealing element is produced from a thermoplastic elastomer that comprises a Shore Hardness A of between 25 and 70.
3. The container as claimed in claim 1, wherein the sealing element is produced from polyisoprene.
4. The container as claimed in claim 1, wherein the second diameter of the second receiving portion is greater than the first diameter of the first receiving portion by between 0.2 mm and 1.5 mm.
5. The container as claimed in claim 1, wherein the first receiving portion and the second receiving portion each comprise an inner toothing that extends around the insertion direction.
6. The container as claimed in claim 1, wherein the sealing element comprises a body and a sealing head, wherein the body is clamped between the connection piece and the attachment part with the attachment part attached to the connection piece, wherein the sealing head connects to the body, and wherein the sealing head comprises the slot opening.
7. The container as claimed in claim 6, wherein the body of the sealing element comprises an outer diameter of between 6 mm and 10 mm and the sealing head, which connects to the body, comprises an outer diameter of between 4 mm and 7 mm.
8. The container as claimed in claim 6, wherein the sealing head is flat, convex, or concave manner on a side remote from the body.
9. The container as claimed in claim 6, wherein the body of the sealing element comprises a cylindrical bore with a diameter that, with the conveying device not attached to the attachment part, is closed by the sealing head against a passage of liquid.
10. The container as claimed in claim 1, wherein the attachment part comprises a threaded portion and a break-off piece, wherein the threaded portion comprises a threaded-portion opening and a thread, wherein the break-off piece is connected to the threaded portion, wherein the threaded portion forms a threaded connection with the conveying device, wherein the break-off piece, when connected to the threaded portion, closes the threaded-portion opening, and wherein, when the break-off piece is removed from the threaded portion, the break-off piece opens the threaded-portion opening.
11. The container as claimed in claim 10, wherein the threaded portion and the break-off piece are formed in one piece, wherein a predetermined breaking point for breaking-off the break-off piece from the threaded portion is arranged between the threaded portion and the break-off piece.
12. A sealing element for a container as claimed in claim 1, wherein the sealing element comprises a body with an outer diameter of between 6 mm and 10 mm and a sealing head which connects to the body with an outer diameter of between 4 mm and 7 mm.
13. An arrangement having a container having a sealing element as claimed in claim 12, which is inserted in a connector with radial play, and a conveying device which comprises a connecting piece for the attachment to the attachment part, wherein, with the conveying device attached to the attachment part, the connecting piece penetrates the slot opening of the sealing element.
14. An arrangement having a container as claimed in claim 1, the arrangement having a connector that is inserted in a connector with radial play and a conveying device that comprises a connecting piece for the attachment to the attachment part, wherein, with the conveying device attached to the attachment part, the connecting piece penetrates the slot opening of the sealing element.
15. The arrangement as claimed in claim 14, wherein the conveying device has an opening cross section through which liquid is transported and wherein, when attached to the attachment part, the conveying device extends through the slot opening and at least 80% of the opening cross section of the conveying device remains uncovered by the sealing element.
16. The container of claim 1, wherein the second receiving portion of the opening is defined by an outer wall and the sealing element does not contact the outer wall with the conveying device not attached.
17. The container of claim 16, wherein, with the conveying device not attached, there exists a space between the outer wall of the second receiving portion and the sealing element.
18. The container of claim 16, wherein the sealing element is radially widened in the second receiving portion with the conveying device attached.
19. The container of claim 18, wherein the sealing element contacts the outer wall with the conveying device attached.
20. A connector for a container for a medical liquid, the connector having a connection piece, through which a medical liquid is conveyable, an attachment part which is attachable to the connection piece and is connectable to a conveying device for conveying a medical liquid through the connection piece, and a sealing element for sealing a transition between the connection piece and the attachment part, wherein the sealing element comprises a slot opening which, with the conveying device not attached to the attachment part, is closed against a passage of liquid and, as a result of attaching the conveying device to the attachment part, is to be opened in such a manner that a medical liquid is conveyable through the slot opening, wherein the attachment part comprises a connecting portion with an opening into which the connection piece is insertable along an insertion direction for connection to the attachment part and the opening comprises a first receiving portion and a second receiving portion which connects axially thereto along the insertion direction, wherein, with the attachment part attached to the connection piece, the first receiving portion receives a head of the connection piece and the second receiving portion receives a portion of the sealing element wherein the first receiving portion comprises a first diameter and the second receiving portion comprises a second diameter, wherein the first diameter is smaller than the second diameter and the sealing element, with the conveying device not attached to the attachment part, is received in the second receiving portion with radial play wherein the sealing element comprises a sealing head and a cylindrical body, and wherein the cylindrical body is not clamped by the attachment part.
21. A sealing element for a connector as claimed in claim 20, wherein the sealing element comprises a body with an outer diameter of between 6 mm and 10 mm and a sealing head, which connects to the body, with an outer diameter of between 4 mm and 7 mm.
Description
(1) The concept underlying the invention is to be explained in more detail below by way of the exemplary embodiments shown in the figures, in which:
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(16) It must be pointed out at this juncture that the present invention is not restricted to a flexible pouch, but can be applied, in principle, to very different containers 1, in particular also ampoules or other bottles for storing medical liquids.
(17) The container 1 includes two connection pieces 11, 12, which provide the two access points into the interior of the container 1. A first connection piece 11 is provided, in this connection, in particular, to feed a medical liquid into the container 1, whilst a second connection piece 12 serves for removing liquid out of the interior of the container 1.
(18) In the case of the exemplary embodiment shown, attachment parts 2, 3 in the form of caps are attached to both connection pieces 11, 12. The connection pieces 11, 12 are closed in a liquid-tight manner to the outside by means of the attachment parts 2, 3 such that no liquid is able to pass out of the container 1 and the container 1 is sealed to the outside against ingress of dirt or the like.
(19) Each attachment part 2, 3 comprises a break-off piece 20, 30 as a tamper-evident closure which can be broken off in order to gain access to the container 1.
(20) Whilst the attachment part 3, which is attached to the second connection piece 12, is configured for the attachment of a conveying device which comprises a mandrel in order to gain access to the container 1 by piercing a sealing element by means of the mandrel and to convey liquid out of the container 1, the first connection piece 11 and the attachment part 2 attached thereto provide so-called needle-free access, by means of which feeding liquid into the container 1 or liquid out of the container 1 can be performed without a needle using a conveying device 5 (see
(21) The container shown in
(22) An exemplary embodiment of a connector with a connection piece 11, an attachment part 2 and a sealing element 4 which, with the attachment part 2 attached to the connection piece 11, rests between the attachment part 2 and the connection piece 11, are shown in
(23) The attachment part 2 includes a connecting portion 21, the basic form of which is cylindrical, to which a threaded portion 22 connects, the basic form of which is also cylindrical. The break-off piece 20 is connected integrally to the threaded portion 22, which carries threads 220 on its outer cylindrical shell surface, a predetermined breaking point 200, which enables a defined separation of the break-off piece 20 from the threaded portion 22 along the predetermined breaking point 200, being realized between the break-off piece 20 and the threaded portion 22.
(24) The attachment part 2 is formed integrally, for example from plastics material by means of plastics material injection molding.
(25) An inner opening 216, to which a conical opening 221, which penetrates the threaded portion 22, is connected, is realized in the connecting portion 21, the basic form of which is cylindrical. The diameter of the opening 221 is tapered in the direction of the inner opening 216.
(26) The attachment part 2 can be attached to a head 110 of the connection piece 11. This is effected by the connection piece 11 being inserted with its head 110 into the opening 216 in an insertion direction E until a positive locking element in the form of a circumferential ring projection 112 on the head 110 moves into engagement in a positive locking manner with a latching engagement 210 in the form of a groove-shaped indentation inside the opening 216.
(27) A first receiving portion 211 connects to the groove-shaped indentation 210 inside the opening 216 in the insertion direction E. A second receiving portion 213, which is continued in the direction of the threaded portion 22 by a third receiving portion 215, connects, in turn, to said first receiving portion 211. In a state in which the attachment part 2 is attached to the head 110 of the connection piece 11, the positive locking element 112, in the form of the circumferential ring projection, engages the latching engagement 210, in the form of the groove-shaped indentation, inside the opening 216 in a positive locking manner. In said state, the head 110, by means of a toothing 111 in the form of an outer toothing, additionally engages a toothing 212 in the form of an inner toothing on the first receiving portion 211. The attachment part 2 is consequently fixed in relation to the connection piece 11 both axially along the insertion direction E and non-rotatably about the insertion direction E such that the attachment part 2 is held on the connection piece 11 in a stationary manner.
(28) In said attached state, the sealing element 4 lies between the attachment part 2 and the connection piece 11, as is shown in
(29) The sealing element 4 realizes a self-sealing diaphragm. Thus, arranged in the sealing head 41 is a slot opening 410 which penetrates the sealing head 41 axially and consequently—when a connecting piece 51 of a conveying device 5 is attached (see
(30) In the state attached together, the sealing element 4 rests with its body 40 in the region of the second receiving portion 213 inside the opening 216 of the connecting portion 21, as is shown in
(31) The second receiving portion 213 comprises a diameter D2 which is greater than the diameter D1 of the first receiving portion 211. The sealing element 4 is inserted with its body 40 consequently with radial play in the second receiving portion 213. A third step 219 is formed as a result between the first receiving portion 211 and the second receiving portion 213. Space to deform the sealing element 4 is created in this way such that the sealing element 4 can be urged aside in a favorable manner when a conveying device 5 is attached to the attachment part 2. The second receiving portion 213 preferably has a diameter D2 which is greater than the diameter D1 of the first receiving portion 211 by between 0.2 mm and 1.5 mm.
(32) The sealing head 41, in this connection, rests in the third receiving portion 215 and in this way, as a result of abutment against a first step 217 of said third receiving portion 215, produces a sealing transition toward the attachment part 2. In addition, the sealing head 41 and the sealing body 40 abut against a second step 218.
(33) In the state attached to one another, the sealing element 4 rests in a clamping manner between the attachment part 2 and the connection piece 11. The sealing head 41, in this connection, provides a liquid-tight separation between the conical opening 221 of the threaded portion 22 and the connection piece 11. The conical opening 221 for receiving a conical connecting piece 51, for example of a conveying device 5, preferably of a Luer syringe or a Luer Lock syringe, is arranged above the sealing element 4.
(34) As can be seen in particular from
(35) The sealing element 4 comprises, on a side 411 of the sealing head 41 remote from the body 40, a flat form. The sealing head 41 is consequently not formed in a concave manner, as has been usual up to now, but is plane on its side 411 that faces the threaded portion 22, which facilitates the attachment of the conveying device 5 and the opening of the slot opening 410 during the attachment process.
(36) The sealing element 4, as shown in
(37) Another exemplary embodiment of a connector with an attachment part 2 is shown in
(38) A conveying device 5 is attached to the attachment part 2 as shown in
(39) When inserting the connecting piece 51 into the opening 221 of the threaded portion 22 and when screwing the connection element 50 in the form of the union nut onto the threaded portion 22, the connecting piece 51 moves into contact with the sealing head 41 of the sealing element 4 and penetrates it by the connecting piece 51 piercing the slot opening 410 and urging the sealing head 41, as is shown schematically in
(40) In the position attached to the attachment part 2, the conveying device 5 penetrates the sealing head 41 of the sealing element 4 preferably entirely by way of its connecting piece 51, as is shown in
(41) With the conveying device 5 attached, the connecting piece 51, the form of which is realized in a conical manner, bears flatly against the correspondingly conically formed opening 221 of the threaded portion 22 such that it seals the transition between the conveying device 5 and the attachment part 2.
(42) The sealing element 4 can be produced from a thermoplastic elastomer and can preferably comprise a Shore Hardness of between 25 and 70, for example of between 30 and 60. Because the sealing element 4 is configured in a comparatively rigid manner in said configuration, the conveying device 5 can urge the sealing element 4 efficiently radially aside by way of its connecting piece 51, in particular without the sealing element 4 stretching axially. The greater degree of hardness of the sealing element 4—compared to sealing elements used hitherto—can consequently facilitate the attaching of the conveying device 5 to the attachment part 2 and improve the creating of a flow F with a large flow diameter. In an alternative embodiment, the sealing element 4 can be produced from polyisoprene.
(43) After conveying a medical liquid out of a syringe body 52 of the syringe 5 into the container 1, the conveying device 5 can be removed from the attachment part 2 again by the connection element 50 being released and the conveying device 5 removed from the attachment part 2. This means that the connecting piece 51 is disengaged from the slot opening 410, as a result of which the slot opening 410 closes again automatically and the sealing element 4 consequently returns into its initial state.
(44) A further exemplary embodiment of a container 1 is shown in
(45) In the case of the exemplary embodiment according to
(46) Two connectors, via which access points to the container 1 are created, are provided by means of the connection pieces 11, 12.
(47) In the case of the exemplary embodiment shown, the one connection piece 11 is connected to an attachment part 2, as has been described previously by way of the exemplary embodiment according to
(48) The other connection piece 12, in contrast, in the case of the exemplary embodiment, is connected to an attachment part 3 in the form of a so-called blind cap, by means of which the connection piece 12, when the container 1 is used subsequently, is fixedly closed such that a user cannot easily access the container 1 by means of the connection piece 12.
(49) The container 1 of the exemplary embodiment according to
(50) The connector, which is formed by the blind cap 3 and the connection piece 12, is shown in an exploded view in
(51) The blind cap 3 serves for the purpose of preventing the use of the connector, which is provided by the connection piece 12, when the container 1 is used subsequently. The blind cap 3 cannot easily be removed by a user and is to remain on the connection piece 12 when the container 1 is used subsequently.
(52) When the container 1 is used subsequently, the connection piece 11 is able to be accessed, in contrast, by the break-off piece 20 being broken off in exactly the same way as has been described previously. A conveying device 5, for example in the form of a syringe or a pump, for example a transfusion pump, can be attached to the attachment part 2 in order to fill liquid into the container 1 or to remove it out of the container 1.
(53) To produce the container 1, first of all the flexible foils, which realize the container 1, are rolled out, laid one on top of the other and are, for example, printed. The weld seams 100 are then applied at the sides and at the lower edge of the container 1 such that the foils are tightly connected together at their side edges and at the bottom. The foils are then cut such that the pouch form shown in
(54) An opening is then applied in the region of the lower weld seam 100 as suspending means for the container 1.
(55) The foils of the container 1 which are laid one on top of the other are then separated from one another at their upper edge, and the connection pieces 11, 12 are inserted with their portions 113, 121 between the foils. The connection piece 11, in this connection, is inserted with the attachment part 2 attached thereto. The connection piece 12, in contrast, is set between the foils without a blind cap 3.
(56) If the connection pieces 11, 12 have been inserted between the foils, the upper weld seam 101 is applied in order to weld the foils together and to the connection pieces 11, 12 in this way. The pouch interior is closed in a liquid-tight manner in this way. Access points are provided by means of the connection pieces 11, 12.
(57) The container 1 is then filled by means of the connection piece 12, for example with a saline solution or another medical liquid. Once the filling has been completed, the blind cap 3 is attached to the connection piece 12 with the sealing element 6 in order to close the connection piece 12 in this way. Because the attachment part 2 is also attached to the other connection piece 11, the container 1 is consequently closed in a liquid-tight manner.
(58) In order to deliver the container 1 for further use, the container 1 is then shrink-wrapped into an additional wrapping by the container 1 being placed between foils and said foils being welded together.
(59) The container 1, in the shrink-wrapped form, can then be sterilized, for example, and, for example, packed in a box.
(60) For actual use, for example in a hospital, the container 1 is then removed out of the box and the foil wrapping is removed by pulling off the foils. The container 1 can be accessed via the connector of the connection piece 11 which provides a Luer Lock port in order, for example, to remove liquid out of the container 1 so as to flush the transfusion set and/or to infuse a patient.
(61) The concept underlying the invention is not limited to the previously depicted exemplary embodiments, but can also be realized, in principle, with completely different embodiments.
(62) In particular, the present invention can also be used in the case of other containers in the form of ampoules or bottles or the like.
(63) In principle, such a container can comprise one or multiple connection pieces with one or multiple similar or different attachment parts to be arranged thereon.
LIST OF REFERENCES
(64) 1 Pouch 10 Pouch body 100, 101 Weld seam 11, 12 Connection piece 110 Head 111 Toothing 112 Positive locking element (ring projection) 113 Widened portion 121 Widened portion 2 Attachment part 20 Break-off part 200 Predetermined breaking point 201 Grip element 21 Connection portion 210 Latching engagement 211 Receiving portion 212 Toothing 213 Receiving portion 214 Toothing 215 Receiving portion 216 Opening 217 First step 218 Second step 219 Third step 22 Threaded portion 220 Thread 221 Opening 223 Lead-in chamfer 224 Projection 3 Attachment part 30 Break-off piece 4 Sealing element 40 Body 41 Sealing head 410 Slot opening 411 Side 42 Interior 43 Annulus 44 Groove or indentation 5 Conveying device (syringe) 50 Connection element 500 Thread 51 Connecting piece (syringe cone) 52 Syringe body 6 Sealing element D1, D2, D3 Diameter E Insertion direction F Flow direction