U.S. patent application number 15/572550 was filed with the patent office on 2018-04-19 for connector for a medical containerr.
The applicant listed for this patent is Fresenius Kabi AB. Invention is credited to Torsten Brandenburger, Lars Karlsson.
Application Number | 20180104148 15/572550 |
Document ID | / |
Family ID | 53054957 |
Filed Date | 2018-04-19 |
United States Patent
Application |
20180104148 |
Kind Code |
A1 |
Karlsson; Lars ; et
al. |
April 19, 2018 |
CONNECTOR FOR A MEDICAL CONTAINERR
Abstract
A connector for a medical container comprises a connector
element to be attached to the medical container for providing a
port to the medical container. The connector element comprises a
head section and a pinch-off section adjoining the head section.
The head section comprises an opening and the pinch-off section
encloses an inner lumen being in fluid connection with the opening
of the head section for proving a fluid path through the connector
element. The pinch-off section is flexibly deformable for pinching
off the fluid path. A closure element is attachable to the head
section for closing the opening of the head section, and a
pierceable membrane element is held between the head section of the
connector element and the closure element. A deflection element
extends from the head section towards the inner lumen for
deflecting a needle of a delivery device when piercing the membrane
element.
Inventors: |
Karlsson; Lars; (Alvsjo,
SE) ; Brandenburger; Torsten; (Reichelsheim,
DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Fresenius Kabi AB |
Uppsala |
|
SE |
|
|
Family ID: |
53054957 |
Appl. No.: |
15/572550 |
Filed: |
May 3, 2016 |
PCT Filed: |
May 3, 2016 |
PCT NO: |
PCT/EP2016/059897 |
371 Date: |
November 8, 2017 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 39/20 20130101;
A61J 1/10 20130101; A61J 1/1425 20150501; A61J 1/1475 20130101;
A61J 1/18 20130101 |
International
Class: |
A61J 1/14 20060101
A61J001/14; A61J 1/18 20060101 A61J001/18; A61J 1/10 20060101
A61J001/10 |
Foreign Application Data
Date |
Code |
Application Number |
May 8, 2015 |
EP |
15166901.7 |
Claims
1-8. (canceled)
9. A connector for a medical container, comprising: a connector
element to be attached to the medical container for providing a
port to the medical container, the connector element comprising a
head section and a pinch-off section adjoining the head section,
wherein the head section comprises an opening and the pinch-off
section encloses an inner lumen being in fluid connection with the
opening of the head section for providing a fluid path through the
connector element, the pinch-off section being flexibly deformable
for pinching off the fluid path through the connector element, a
deflection element extending from the head section towards the
inner lumen of the pinch-off section for deflecting a needle of a
delivery device when piercing the membrane element wherein the
deflection element reaches into the inner lumen of the pinch-off
section.
10. The connector according to claim 9, wherein said connector
further comprises, a closure element attachable to the head section
of the connector element for closing the opening of the head
section, and a membrane element being pierceable by a needle of a
delivery device for injecting a medical fluid into the medical
container or for extracting a medical fluid from the medical
container.
11. The connector according to claim 9, wherein the deflection
element has the shape of a cylindrical pipe.
12. The connector according claim 9, wherein the deflection element
comprises a guide opening which is aligned with the opening of the
head section along an insertion direction along which the needle of
the delivery device is insertable into the opening of the head
section.
13. The connector according claim 9, wherein the deflection element
is arranged radially inside the pinch-off section at a distance to
walls forming the pinch-off section.
14. The connector according to claim 9, wherein the connector
element has the shape of a ship-shaped conus.
15. The connector according to claim 9, wherein the connector
element comprises a fastening section to be fastened to the medical
container, wherein walls of the pinch-off section have a reduced
wall thickness in comparison to walls of the fastening section.
16. The connector according to claim 9, wherein the closure element
comprises an attachment section attachable to the head section of
the connector element and a break-off part connected to the
attachment section along a break line along which the break-off
part can be broken off the attachment section.
17. The connector according to claim 10, wherein the deflection
element has the shape of a cylindrical pipe.
18. The connector according claim 10, wherein the deflection
element comprises a guide opening which is aligned with the opening
of the head section along an insertion direction along which the
needle of the delivery device is insertable into the opening of the
head section.
19. The connector according claim 10, wherein the deflection
element is arranged radially inside the pinch-off section at a
distance to walls forming the pinch-off section.
20. The connector according to claim 10, wherein the connector
element has the shape of a ship-shaped conus.
21. The connector according to claim 10, wherein the connector
element comprises a fastening section to be fastened to the medical
container, wherein walls of the pinch-off section have a reduced
wall thickness in comparison to walls of the fastening section.
22. The connector according to claim 10, wherein the closure
element comprises an attachment section attachable to the head
section of the connector element and a break-off part connected to
the attachment section along a break line along which the break-off
part can be broken off the attachment section.
23. The connector according claim 11, wherein the deflection
element comprises a guide opening which is aligned with the opening
of the head section along an insertion direction along which the
needle of the delivery device is insertable into the opening of the
head section.
24. The connector according claim 12, wherein the deflection
element is arranged radially inside the pinch-off section at a
distance to walls forming the pinch-off section.
25. The connector according to claim 12, wherein the connector
element has the shape of a ship-shaped conus.
26. The connector according to claim 12, wherein the connector
element comprises a fastening section to be fastened to the medical
container, wherein walls of the pinch-off section have a reduced
wall thickness in comparison to walls of the fastening section.
27. The connector according to claim 12, wherein the closure
element comprises an attachment section attachable to the head
section of the connector element and a break-off part connected to
the attachment section along a break line along which the break-off
part can be broken off the attachment section.
28. The connector according to claim 12, wherein the deflection
element has the shape of a cylindrical pipe.
Description
[0001] The invention relates to a connector for a medical container
according to the preamble of claim 1.
[0002] A connector of this kind comprises a connector element to be
attached to the medical container for providing a port to the
medical container. The connector element comprises a head section
and a pinch-off section adjoining the head section, wherein the
head section comprises an opening and the pinch-off section
encloses an inner lumen being in fluid connection with the opening
of the head section for providing a fluid path through the
connector element. The opening of the head section can be closed by
a closure element which is attachable to the head section of the
connector element such that, when the closure element is attached
to the head section, the fluid path through the connector element
is blocked. A membrane element can be placed in-between the closure
element and the head section of the connector element. The membrane
element can be pierced by a needle of a delivery device, for
example a syringe, for injecting a medical fluid into the medical
container or for extracting a medical fluid from the medical
container.
[0003] The connector, when attached to a medical container, shall
allow for filling the medical container with a medical fluid, for
example a fluid for the parenteral feeding of a patient such as a
glucose solution, a fat solution or an amino acid solution. The
medical container herein may be filled for example by a medical
supplier (which may be the container manufacturer) or in a pharmacy
of a hospital and shall subsequently be prepared such that it can
be stored and delivered for a later usage.
[0004] For filling the container, as it is described in WO
2004/084793 A1, a filling spike of a filling station may be
inserted into the connector element prior to attaching the closure
element to the connector element. After the filling is completed,
the connector element is pinched-off at its pinch-off section such
that the fluid path through the connector element is closed and
fluid cannot exit from the medical container through the connector
element. By attaching the closure element to the head section of
the connector element, then, the connector element is sealed
towards the outside such that the pinching of the pinch-off section
can be released and the medical container can be stored or
delivered to a hospital or the like.
[0005] When using the medical container on a patient, the closure
element may be opened, for example by breaking-off a break-off
part. A user hence may access the connector element by piercing the
membrane element placed in-between the head section of the
connector element and the closure element using for example a
needle of a syringe. In this way, fluid may be extracted from the
medical container, or fluid may be added to the medical container
in order to for example add further components such as vitamins or
other nutritional components or the like to the fluid contained in
the container.
[0006] When piercing the membrane element using a needle, it shall
be avoided that the needle comes into contact with the pinch-off
section of the connector element, e.g. because the pinch-off
section could have a reduced wall thickness in order for it to be
deformable for pinching off the connector element. If the needle
were to come into contact with the pinch-off section, there may be
a risk of damaging the pinch-off section, possibly rendering the
medical container unsterile and hence useless. It is clear that the
invention relates to any kind of pinch-off section being in the
danger to be damaged by the needle. Reasons therefore may the
thickness of the wall, selection of material of the wall or other.
The invention will be described by a connector with thinner walls
at the pinch-off section in way of example only.
[0007] It is an object of the invention to provide a connector for
a medical container which in an easy and cost-efficient manner
reduces the risk of damaging the pinch-off section of the connector
element when piercing the membrane element by means of a
needle.
[0008] This object is achieved by means of a connector comprising
the features of the independed claims.
[0009] Accordingly, a deflection element is provided which extends
from the head section towards the inner lumen of the pinch-off
section for deflecting a needle of a delivery device when piercing
the membrane element.
[0010] The deflection element serves to guide the needle towards
the inner lumen of the pinch-off section when piercing the membrane
element by means of the needle. The deflection element herein is
shaped such that the risk for damaging the pinch-off section by
means of the needle, when introducing it into the connector
element, is reduced, in particular in that the needle is guided
such that it would not come into contact with the walls of the
pinch-off section.
[0011] In one embodiment, the deflection element reaches into the
inner lumen of the pinch-off section. The deflection element hence
extends from the head section and reaches into the inner lumen
enclosed by the pinch-off section. Herein, the deflection element
is formed as a comparatively rigid piece and in particular may be
formed in one piece with the head section. When a needle is
inserted into the opening of the head section, it is deflected by
the deflection element or is stopped by the deflection element such
that the needle cannot come into contact with the walls of the
pinch-off section.
[0012] Although the deflection element may reach into the inner
lumen of the pinch-off section, it extends into the inner lumen of
the pinch-off section only that far that a pinching off of the
pinch-off section is not hindered. In particular, the deflection
element does not extend into a region of the pinch-off section in
which (typically) a pinching off shall take place.
[0013] The deflection element may for example have the shape of a
cylindrical pipe. The deflection element extends from the head
section and provides a guide for the needle such that the needle
cannot come into contact with walls of the pinch-off section when
inserting it into the connector element.
[0014] In one embodiment, the deflection element, for example
having the shape of a cylindrical pipe, comprises a guide opening
through which the needle may be guided. The guide opening
longitudinally extends along an insertion direction along which the
needle of the delivery device can be inserted into the connector
element. Along the insertion direction, the guide opening
beneficially is aligned with the opening of the head section of the
connector element through which the needle of the delivery device
is inserted into the connector element.
[0015] The deflection element, in one embodiment, is arranged at a
radial distance to the walls of the pinch-off section. The
deflection element, hence, is arranged radially inside the
pinch-off section such that it provides a guide inside of the
pinch-off section. Because the walls of the pinch-off section are
arranged radially outside of the deflection element at a radial
distance to the deflection element, a needle guided by the
deflection element cannot come into contact with the walls of the
pinch-off section such that the risk for damaging the walls of the
pinch-off section when inserting the needle into the connector
element is greatly reduced.
[0016] The connector element may for example have the shape of a
ship-shaped conus. The connector element hence has a general ship
shape and comprises for example a fastening section which can be
inserted in-between foils of the medical container such that the
connector element via its fastening section can be welded to the
foils of the medical container (having the shape of for example a
flexible bag). Herein, the fastening section has a rather rigid
shape and has an increased wall thickness in comparison to walls of
the pinch-off section. Because the walls of the pinch-off section
have a reduced wall thickness (at least in particular regions), the
pinch-off section is flexibly deformable for pinching-off the fluid
path through the connector element after filling the medical
container.
[0017] The closure element may for example comprise an attachment
section attachable to the head section of the connector element and
a break-off part connected to the attachment section along a break
line along which the break-off part can be broken off the
attachment section. The closure element may for example be attached
to the connector element after filling of the medical container
such that, with the closure element attached, the medical container
can be stored or delivered for example to a hospital. When a user
wants to access the medical container for example to inject a
medical fluid into the medical container or to extract a medical
fluid from the medical container, he breaks off the break-off part
and hence opens the connector element such that the membrane
element placed in-between the closure element and the connector
element is accessible from the outside for piercing it by means of
a needle of a suitable delivery device, for example a syringe or
the like.
[0018] The idea underlying the invention shall subsequently be
described in more detail with reference to the embodiments shown in
the figures. Herein,
[0019] FIG. 1 shows a schematic view of a medical container in the
shape of a three-chamber flexible bag comprising three
connectors;
[0020] FIG. 2A shows a front view of a connector element of a
connector;
[0021] FIG. 2B shows a side view of the connector element;
[0022] FIG. 2C shows a top view of the connector element;
[0023] FIG. 3A shows a sectional view along line A-A according to
FIG. 2A;
[0024] FIG. 3B shows a sectional view along line B-B according to
FIG. 2B;
[0025] FIG. 4A shows a sectional view of the connector element with
a closure element attached to a head section of the connector
element; and
[0026] FIG. 4B shows the view of FIG. 4A, with a break-off part
broken off the closure element and with a needle of a delivery
device inserted into the connector element.
[0027] FIG. 1 shows in a schematic view a medical container 1 in
the shape of a flexible bag made of thin, flexible foils welded to
each other. The medical container 1, in the shown embodiment,
comprises three chambers 10-12 for receiving medical fluids, for
example for the parenteral feeding of a patient. The chambers 10-12
herein may contain different medical fluids, for example a glucose
solution, a fat solution and an amino acid solution, wherein the
chambers 10-12 may be connected via tearable seams which may be
torn open to bring the chambers 10-12 in fluid connection with each
other for mixing the different solutions with each other prior to
delivering them to a patient.
[0028] Each chamber 10-12 is associated with a connector 2, as
shown in FIG. 1. The chambers 10-12 herein are filled via their
respective connectors 2, for example by a medical supplier or
within a hospital pharmacy or the like. After the chambers 10-12
have been filled, the connectors 2 are closed such that the
chambers 10-12 are sealed towards the outside and the medical
container can be stored or delivered for use on a patient. The
mixing of the different solutions contained in the chambers 10-12
then takes place immediately prior to injecting the medical fluid
of the medical container 1 to a patient in that a user, for example
a nurse, tears open the tearable seams in-between the chambers
10-12 such that the solutions contained in the chambers 10-12 can
mix within the medical container 1.
[0029] As shown in FIGS. 4A and 4B, each connector 2 comprises a
connector element 20, a closure element 21 and a membrane element
22 placed in-between the closure element 21 and the connector
element 20.
[0030] Detailed views of the connector element 20 are provided in
FIGS. 2A to 2C and 3A and 3B. The connector element 20 comprises a
fastening section 200 which can be inserted in-between foils of the
medical container 1 for welding the connector element 20 to the
medical container 1. The fastening section 200 is adjoined by a
pinch-off section 201, which terminates in a head section 202. To
the head section 202 the closure element 21 is attached via an
attachment section 210 in a form locking manner by engaging with a
locking rim 203 of the head section 202.
[0031] The closure element 21, when it is attached to the head
section 202 of the connector element 20, closes off an opening 204
in the head section 202. The closure element 21 comprises a head
section 211 adjoining the attachment section 210 and being
connected, in the state of FIG. 4A, to a break-off part 214 along a
circumferential break line 213.
[0032] For manufacturing the medical container 1, the connector
elements 20 of the connectors 2 are placed in-between the foils of
the medical container 1 and are welded to the foils when forming
the chambers 10-12 of the medical container 1. After completion of
the manufacturing, the chambers 10-12 of the medical container 1
are filled for example by a medical supplier or in a pharmacy of a
hospital by inserting a filling spike into the respective connector
elements 20 and by filling the chambers 10-12 with medical
solutions as desired.
[0033] Once a chamber 10-12 has been filled, the respective
connector element 20 is pinched-off at its pinch-off section 201 by
applying a suitable clamping device. For this, the connector
element 20 is flexibly deformable at its pinch-off section 201,
which comprises a reduced wall thickness W1 in comparison to other
sections of the connector element 20, for example in comparison to
a wall thickness W2 of the walls 208 of the fastening section 201,
as depicted in FIG. 3A.
[0034] By pinching off the connector element 20 at its pinch-off
sections 201, a fluid path through the connector element 20 is
blocked in that an inner lumen L enclosed by the pinch-off section
201 is pinched-off. Subsequently, the closure element 21 can be
attached to the head section 202 of the connector element 20 for
closing the connector element 20, and the pinching of the pinch-off
section 201 can be released.
[0035] After all chambers 10-12 have been filled and respective
closure elements 21 have been attached to the connector elements 20
of the connectors 2, the medical container 1 can be stored or can
be delivered to a place of usage, for example to a hospital.
[0036] Once the medical solution contained in the medical container
1 shall be administered to a patient, a user may break off one or
multiple of the break-off parts 214 of the closure elements 21 of
the connectors 2 and may insert a needle 30 of a suitable delivery
device 3, for example a syringe, into an opening 212 within the
head section 211 of the closure element 21 and may pierce the
membrane element 22 held in-between the closure element 21 and the
connector element 20. By piercing the membrane element 22 by means
of the needle 30 and by inserting the needle 30 in an insertion
direction I into the connector element 20 through the opening 204
of the head section 202 of the connector element 20, a medical
fluid may be added to the medical container 1 or a medical fluid
may be extracted from the medical container 1. For example, if the
medical container 1 comprises different solutions for the
parenteral feeding of a patient, further components such as
vitamins or the like may be added via one of the connectors 2 prior
to administering the (mixed) solutions to a patient.
[0037] The membrane element 22 is constituted as a self-sealing
membrane which, after removing the needle 30 of the delivery device
3, seals itself such that the connector element 20 is closed in a
fluid-tight manner towards the outside.
[0038] When inserting the needle 30 of the delivery device 3
through the head section 202 of the connector element 20 towards
the inner lumen L enclosed by the pinch-off section 201, it shall
be avoided that the needle 30 pierces the walls 207 of the
pinch-off section 201 (having a reduced wall thickness W1 as shown
in FIG. 3A). For this, a deflection element 205 having the shape of
a cylindrical pipe is provided which extends from the head section
202 towards the inner lumen L of the pinch-off section 201, as
shown in the sectional views of FIGS. 3A and 3B. The deflection
element 205 comprises a longitudinal guide opening 206 which is
aligned along the insertion direction I with the opening 204 of the
head section 202 such that the needle 30 of a delivery device 3 is
guided via the deflection element 205 towards the inner lumen L of
the pinch-off section 201, as shown in FIG. 4B.
[0039] The deflection element 205 in the shape of a cylindrical
pipe is formed in one piece with the connector element 20 and has a
rigid shape such that a needle 30 pinching onto the inner
circumferential face of the guide opening 206 is deflected and
guided in the insertion direction I or is stopped such that it
cannot come into contact with the outer walls 207 of the pinch-off
section 201. Hence, the risk that the walls 207 of the pinch-off
section may be damaged by the needle 30 is reduced.
[0040] The deflection element 205 extends from the head section 202
in the insertion direction I and reaches into the inner lumen L of
the pinch-off section 201. It herein is placed inside the pinch-off
section at a radial distance to the walls 207.
[0041] Although the deflection element 205 reaches into the inner
lumen L of the pinch-off section 201, it does not extend through
the pinch-off section 201 and in particular reaches into the inner
lumen L only that far that a reliable pinching of the pinch-off
section 201 is not hindered.
[0042] The connector element 20, as visible from the top view of
FIG. 2C, has the general shape of a ship, with the fastening
section 200 reducing in width towards both sides along a horizontal
direction H such that the fastening section 200 may be reliably
welded to the foils of the medical container 1 for providing a
fluid-tight transition. The pinch-off section 201 likewise does not
have a circular cross-section, but is formed such that it may be
reliably pinched-off in a pinch-off direction P (see FIG. 3A) for
closing off the fluid path through the connector element 20, as it
is described for example in WO 2004/084793 A1.
[0043] The invention is not limited to the embodiments described
above, but may be implemented in an entirely different fashion.
[0044] In particular, the invention is not limited to three-chamber
medical bags, but may be applied to any sort of medical containers,
having one, two or more chambers.
[0045] The medical container not necessarily is flexible, but may
also have a rigid shape, such as the shape of a bottle or the
like.
[0046] Each chamber of the medical container may be provided with
one, two or more connector(s) according to the present invention.
It is also understood that the medical container may provided with
a mixture of both, inventive connector(s) and connector(s)/port(s)
of the prior art, depending of the needs for the use of said
container.
LIST OF REFERENCE NUMERALS
[0047] 1 Medical container (bag) [0048] 10-12 Chamber [0049] 2
Connector [0050] 20 Connector element [0051] 200 Fastening section
[0052] 201 Pinch-off section [0053] 202 Head [0054] 203 Locking rim
[0055] 204 Opening [0056] 205 Deflection element [0057] 206 Guide
opening [0058] 207, 208 Walls [0059] 21 Closure element [0060] 210
Attachment section [0061] 211 Head section [0062] 212 Opening
[0063] 213 Break line [0064] 214 Break-off part [0065] 22 Membrane
[0066] 3 Delivery device [0067] 30 Needle [0068] H Horizontal
direction [0069] I Insertion direction [0070] L Inner lumen [0071]
P Pinch-off direction [0072] W1, W2 Wall thickness
* * * * *