Connector for a medical package containing a liquid

11464707 · 2022-10-11

Assignee

Inventors

Cpc classification

International classification

Abstract

The invention relates to a connector for a medical package containing a liquid. The connector comprises a lower section which has a connecting piece for a container of said medical package and a passageway which is closed by a septum, as well as an upper section which is provided with a cap that covers the septum and can be broken off, said septum having, on a top side, a plurality of connections in the form of elevations, for a spike and/or for a needle.

Claims

1. A connector for a medical package containing a liquid, said connector comprising: a lower part, which has a connecting piece for a container of the medical package, and a passage, a septum, which closes the passage of the lower part, and an upper part, which is placed onto the lower part and is provided with a cap that covers the septum and can be broken off, wherein the septum has, on a top side thereof, a plurality of ports configured as elevations for a spike and/or for a needle, wherein: the ports lead into the lower part, the ports on the top side of the septum are configured as dome-shaped elevations, and each port includes: radially-spaced ring portions disposed on the dome-shaped elevations, wherein the radially-spaced ring portions define gaps, and a plurality of slits formed within the dome-shaped members, each of the slits extending through one of the gaps.

2. The connector as claimed in claim 1, wherein, after the cap has been broken off, the top side of the septum is accessible for wiping the ports.

3. The connector as claimed in claim 1, wherein at the top side of the septum protrudes above an adjoining predetermined breaking line for the cap.

4. The connector as claimed in claim 1, wherein a gap present between the cap and the septum is hermetically sealed off by the cap and is made available in a sterile state.

5. The connector as claimed in claim 1, wherein a cross section of the passage in the lower part of the connector tapers at least partially from the septum in the direction of the connecting piece.

6. The connector as claimed in claim 1, wherein the connecting piece of the lower part has substantially a ship shape.

7. The connector as claimed claim 1, wherein, after the cap has been broken off, the septum has an accessible diameter of more than ten millimeters.

8. The connector as claimed in claim 1, wherein the septum comprises a form-fit element, which is fixed between the upper part and the lower part of the connector.

9. The connector as claimed in claim 1, wherein an underside of the septum has tubular guides arranged beneath the ports.

10. The connector as claimed in claim 9, wherein an underside of the tubular guides is lower than an underside of the form-fit element.

11. The connector as claimed in claim 9, wherein an underside of the tubular guides merges flush into an underside of an annular portion of the septum lying internally in relation to the form-fit element.

12. A medical package with a container that is configured as an infusion bag, transfusion bag or enteral bag, or as a bottle containing medical liquid, comprising a connector as claimed in claim 1.

13. The connector as claimed in claim 1, wherein at the top side of the septum is substantially flush with an adjoining predetermined breaking line for the cap.

14. The connector of claim 1, wherein the cap forms a top portion of the upper part.

15. The connector of claim 1, wherein the cap is a tamper-evident seal.

16. The connector of claim 1, wherein the cap is configured to be broken off from the upper part.

17. The connector as claimed claim 1, wherein, after the cap has been broken off, the septum has an accessible diameter of more than twelve millimeters.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The subject matter of the invention is explained in more detail below on the basis of an illustrative embodiment and with reference to FIG. 1 to FIG. 9 of the drawings.

(2) FIG. 1 is a perspective view of an illustrative embodiment of a connector according to the invention.

(3) FIG. 2 is an exploded view of the connector shown in FIG. 1.

(4) FIG. 3 is a side view and FIG. 4 a sectional view of the connector.

(5) FIG. 5 and FIG. 6 are perspective views of the septum at its top side (FIG. 5) and its underside (FIG. 6), which septum is part of the connector already shown.

(6) FIG. 7 is a plan view of the top side of the septum, and FIG. 8 is a sectional view along the line A-A in FIG. 7.

(7) FIG. 9 shows a schematic view of a medical package provided with a connector.

DETAILED DESCRIPTION OF THE DRAWINGS

(8) FIG. 1 is a perspective view of an illustrative embodiment of a connector 1 according to the invention. The connector 1 comprises a lower part 2, and an upper part 3 placed onto the lower part 2. The lower part 2 comprises, at a lower end, a connecting piece 4 for a container 21 of the medical package 20.

(9) In this illustrative embodiment, the connecting piece 4 does not have the shape of a circular cylinder, and instead it has a ship shape, which makes it easier, for example, to attach a container 21 configured as a bag. The connecting piece 4 is welded into the weld seam forming the edge of the bag (see FIG. 9 in this respect). The connecting piece 4 can preferably have a substantial wall thickness, e.g. such that it cannot be pierced by a needle and/or by a spike.

(10) The upper part 3 has a larger external diameter than the adjoining lower part 2 in the region above the connecting piece 4 of the lower part 2. In the case of a shape that is not a circular cylinder, the respectively largest diameter of the two parts to be compared is the diameter in question.

(11) The upper part 3 is moreover provided with a cap 5 which can be broken off and which forms the top portion of the upper part 3. The cap 5 is here configured as a flat gripping piece, the cross section of which changes from a circular shape toward a plate-shaped configuration. The cap 5, connected via a predetermined breaking line 10, can thus be easily broken off from the upper part 3.

(12) In the lower region of circular cross section, the cap 5 has a smaller diameter than the bottom portion of the upper part 3.

(13) The cap 5 constitutes a tamper-evident seal. After the cap 5 has been broken off, the top side 11 of the septum 6 (not seen here) is accessible.

(14) Moreover, an opening configured as an arrow is introduced in the plate-shaped portion of the break-off cap 5, which opening identifies the connector 1 depicted here as a withdrawal connector.

(15) FIG. 2 is an exploded view of the connector 1 and shows the individual parts of the latter. The connector 1 is formed by the lower part 2, the upper part 3 placed onto the lower part 2, and the septum 6 inserted between the upper part 3 and the lower part 2.

(16) The lower part 2 and the upper part 3 of the connector 1 are here connected to each other by means of a form-fit connection, for example a snap connection. In this illustrative embodiment, the lower part 2 comprises a radially extending collar 7, onto which the upper part 3 is pushed. The septum 6 is thus fixed with form-fit engagement, and preferably also with clamping, between the lower part 2 and the upper part 3. The collar 7 can in this case engage in a recess formed on the inner face of the upper part 3 or can engage behind a projection (not shown in FIG. 2) arranged on the inner face of the upper part 3.

(17) In an alternative or supplementary embodiment (not shown), the upper part 3 and the lower part 2 are welded or adhesively bonded to each other or are configured as one piece.

(18) FIG. 3 is a side view of the connector 1 and in particular shows that the cap 5 is configured as a flat gripping piece.

(19) FIG. 4 is a sectional view of the connector 1 along the line W-W, rotated through 90° from FIG. 3.

(20) The lower part 2 has a passage 8 which, starting from the upper part 3, tapers both in external diameter and in internal diameter in the direction of the connecting piece 4.

(21) At its upper end, the passage 8 is closed by the septum 6.

(22) In this illustrative embodiment, the septum 6 is inserted between the upper part 3 and the lower part 2. The septum 6 comprises a T-shaped form-fit element 9 issuing from its edge. An upper arm of the T-shaped form-fit element 9 sits in a corresponding groove of the upper part 3. The lower part 2 comprises, on its top side, a circumferential web 17 extending in the axial direction. A lower arm of the T-shaped form-fit element 9 engages behind the web 17. The elastic septum 6 cannot therefore be pressed out by the action of an axial force.

(23) The top side of the form-fit element 9 lies below the top side 11 of the central portion of the septum 6. Thus, the top side 22 of the upper part 3 can extend over the form-fit element 9 and in so doing lie flush with the adjoining top side 11 of the central portion of the septum 6.

(24) Since the top side 22 of the upper part 3 and the top side 11 of the septum 6 lie approximately on one plane, the top side 11 of the septum 6 is easily accessible after the cap 5 has been broken off and can in particular be easily wiped clean.

(25) In this illustrative embodiment, the underside 16 of the central portion of the septum 6 lies lower than the underside of the T-shaped form-fit element 9.

(26) The cap 5 is connected to the upper part 3 via an annular predetermined breaking line 10. The predetermined breaking line 10 is flush with the adjoining top side 11 of the septum 6. Moreover, the predetermined breaking line 10 directly adjoins the surface 11 of the septum 6 that is accessible after the cap has been broken off.

(27) The top side 11 of the septum 6 lies completely free or substantially completely free after the cap 5 has been removed. The three ports 12a, 12b, 12c and the surfaces present between the ports 12a, 12b, 12c are not covered, e.g. by a housing portion of the connector 1.

(28) The top side 11 of the septum 6 has no depressions. After the cap 5 has been broken off, a relatively smooth surface is thus obtained that is composed of the top side 11 of the septum 6 and the top side 22 of the upper part 3.

(29) Between the cap 5 and the septum 6, a gap 19 is present which is preferably sterilized. Since the predetermined breaking line 10 has no openings, the gap 19 is sealed off hermetically.

(30) In this illustrative embodiment, the connector 1 is assembled by pushing the upper part 3 onto the lower part 2. After the upper part 3 has been pushed on, a circumferential web 18 of the upper part 3 and/or several latching hooks of the upper part 3 (which are not shown in the figures) engage under the circumferential collar 7 of the lower part 2. In an alternative or supplementary embodiment, the collar 7 of the lower part 2 engages in a depression (not shown in the figures) introduced on the inner face of the upper part 3.

(31) FIG. 5 is a perspective detailed view of the septum 6, in which the top side 11 can be clearly seen.

(32) The septum 6 is made of an elastomer material, for example a polyisoprene. The latter can be crosslinked, for example, peroxidically or by means of sulfur bridges.

(33) The figure reveals the circumferential T-shaped form-fit element 9 at the edge, by means of which a groove 14 is formed between the form-fit element 9 and the top side 11. In the assembled state, a corresponding web of the upper part 3 engages in this groove 14.

(34) In this illustrative embodiment, three ports 12a-12c are present on the top side 11.

(35) The ports 12a-12c are distributed uniformly at the circumference of the septum. The angle of virtual connecting lines to the center point of the septum 6 is thus approximately 120° in each case. The three ports 12a-12c form the corners of a triangle, preferably an equilateral triangle.

(36) In this illustrative embodiment, the three ports 12a-12c are each configured to receive a spike. They each comprise slits 24 formed in a cross shape. The slits 24 serve as a guide for a spike. In this illustrative embodiment, the slits 24 do not extend completely through the septum 6. In another embodiment (not shown here), the slits 24 run the full height of the septum 6.

(37) In an embodiment not shown here, it is possible that a port is not slit and can serve to receive a needle.

(38) The ports 12a-12c in this illustrative embodiment are configured as dome-shaped elevations. The slits 24 of the ports 12a-12c intersect in a flattened region of the dome formed by the respective port 12a-12c (in this connection see also the cross-sectional view shown in FIG. 4).

(39) The puncture regions for the spikes on the top side 11 of the septum 6, which regions are defined by the intersecting slits 24 in the three ports 12a-12c, are each enclosed by an annular circumferential web 13. In this illustrative embodiment, the web 13 at the same time forms the boundary of the flattened region of the dome. The annular circumferential webs 13 are each interrupted at several places. The slits 24 extend through the interruptions and into the downwardly sloping region 26 of the dome, which is formed by the respective port 12a-12c.

(40) The geometric configuration shown here permits good accessibility and maneuverability of the puncture sites of the septum 6.

(41) To receive the ports 12a-12c, the accessible surface 11 of the septum 6 preferably has a diameter of 10 mm to 20 mm, preferably of 12 mm to 16 mm.

(42) The total height of the septum is preferably between 5 mm and 20 mm.

(43) The diameter of the flattened region of the dome, bounded by the annular webs 13, is preferably 2 mm to 5 mm.

(44) FIG. 6 is a perspective view in which the underside of the septum 6 can be clearly seen.

(45) Tubular guides 15a to 15c, each provided for a respective spike and/or needle, extend beneath the ports 12a to 12c.

(46) The tubular guides 15a to 15c merge at the edge into an annular portion 27 of the septum 6, which annular portion 27 constitutes the underside 16 of the septum 6. In the assembled state, this annular region 27 bears on the inner wall of the passage 8 of the lower part 2.

(47) The tubular guides 15a to 15c preferably have a depth of 1 mm to 6 mm.

(48) The gap 28 between the tubular guides 15a to 15c is not filled with material, such that the septum 6, in the region of the gap 28, has approximately the same thickness as in the region of the ports 12a to 12c.

(49) Since there are no ports located in the region of the gap 28, the gap 28 in an embodiment not shown here can also be filled with material as far as the underside 16.

(50) In the region of the ports 12a to 12c, the thickness of the septum 6 is preferably 1 mm to 5 mm.

(51) FIG. 7 is a plan view of the top side of the septum 6 with the three ports 12a to 12c.

(52) FIG. 8 is a sectional view of the septum 6 along the line A-A from FIG. 7.

(53) It will be seen in particular how the dome-shaped ports 12a to 12c protrude from the adjoining surface 11 of the septum 6.

(54) The top side 23 of the T-shaped form-fit element 9 lies deeper than the accessible surface of the septum 6 formed by the top side 11.

(55) The underside 25 of the T-shaped form-fit element 9 lies higher than the underside of the annular portion 27, which constitutes the underside 16 of the septum 6. The underside of the annular portion 27 merges flush into the underside of the annular guide 15a.

(56) FIG. 9 shows schematically how the connector 1 described above is connected to the container 21 of a medical package 20.

(57) In this illustrative embodiment, the connecting piece 4 of the connector 1 is welded to a container 21 configured as a bag. The connecting piece 4 is welded into the weld seam of the container 21.

(58) By way of the connector 1, liquid can be withdrawn from the container 21 and also delivered to it. The container 21 can also be filled by way of the connector 1, in particular with the upper part 3 not yet fitted.

(59) In the example shown, the container 21 has only a single connector 1. The connector 1 is preferably used only for withdrawal by means of a spike. The connector 1 is in this case a withdrawal connector.

(60) By means of the invention, a connector can be made available that is easy to handle and that permits flexible use.

LIST OF REFERENCE SIGNS

(61) 1 connector 2 lower part 3 upper part 4 connecting piece 5 cap (that can be broken off) 6 septum 7 collar 8 passage 9 form-fit element 10 predetermined breaking line 11 top side of the septum 12a-12c port 13 web 14 groove 15a-15c tubular guide 16 underside of the tubular guide and/or of the septum 17 web 18 web 19 gap 20 package 21 container 21-1 weld seam of the container 22 top side 23 top side (of the form-fit element 9) 24 slit 25 underside (of the form-fit element 9) 26 downwardly sloping region 27 annular portion 28 gap