U.S. patent application number 11/993383 was filed with the patent office on 2010-07-15 for packing for an infusion set and method of applying an infusion set.
This patent application is currently assigned to UNOMEDICAL A/S. Invention is credited to Carl J.D. Ahman, Steffen Gyrn, Lasse W. Mogensen, Jesper T. Olsen, May B. Svendstrup.
Application Number | 20100179508 11/993383 |
Document ID | / |
Family ID | 35429309 |
Filed Date | 2010-07-15 |
United States Patent
Application |
20100179508 |
Kind Code |
A1 |
Mogensen; Lasse W. ; et
al. |
July 15, 2010 |
PACKING FOR AN INFUSION SET AND METHOD OF APPLYING AN INFUSION
SET
Abstract
The present invention relates to a packing for an infusion set.
An infusion set for intermittent or continuous administration of a
therapeutical substance, such as insulin, comprises an infusion
part having a cannula penetrating the skin of a patient and a
connector which connects the infusion part with a medical device
such as an adaptor for a syringe or an insulin pump. The insertion
of the infusion part will be performed with an insertion needle
which is delivered together with the infusion part under sterile
conditions. The packaging comprises an impenetrable part (7)
protecting the surroundings from the insertion needle and a removal
part (8) which is to be removed by the user before applying the
infusion part. The inner surface of the impenetrable part (7) is
provided with means (7a) for releasable retaining at least a part
of the infusion set.
Inventors: |
Mogensen; Lasse W.; (Soborg,
DK) ; Olsen; Jesper T.; (Copenhagen, DK) ;
Ahman; Carl J.D.; (Malmo, SE) ; Svendstrup; May
B.; (Viby Sjaelland, DK) ; Gyrn; Steffen;
(Ringsted, DK) |
Correspondence
Address: |
BRINKS HOFER GILSON & LIONE
P.O. BOX 10395
CHICAGO
IL
60610
US
|
Assignee: |
UNOMEDICAL A/S
Birkered
DK
|
Family ID: |
35429309 |
Appl. No.: |
11/993383 |
Filed: |
June 8, 2006 |
PCT Filed: |
June 8, 2006 |
PCT NO: |
PCT/DK2006/000318 |
371 Date: |
January 7, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60694547 |
Jun 28, 2005 |
|
|
|
Current U.S.
Class: |
604/506 ;
206/365; 29/428; 53/492 |
Current CPC
Class: |
A61M 2005/1585 20130101;
A61M 5/002 20130101; A61M 5/158 20130101; A61M 2005/1581 20130101;
Y10T 29/49826 20150115 |
Class at
Publication: |
604/506 ;
206/365; 29/428; 53/492 |
International
Class: |
A61M 5/32 20060101
A61M005/32; A61B 19/02 20060101 A61B019/02; B23P 17/04 20060101
B23P017/04 |
Foreign Application Data
Date |
Code |
Application Number |
Jun 28, 2005 |
DK |
PA200500958 |
Claims
1. Packaging for an infusion set comprising an infusion part and a
needle hub, the needle hub including an insertion needle, the
packaging comprising: a support part for holding the infusion part
and the needle hub, an impenetrable part at least partially
surrounding the infusion part and protecting the surroundings from
the insertion needle, the impenetrable part comprising a retainer
on an inner surface of the impenetrable part for releasably
retaining at least a part of the infusion set; and a removable
cover covering at least a portion of an opening defined in the
packaging, the cover configured to be removed by the user before
applying the infusion part.
2. Packaging according to claim 1, wherein the retainer is an
integrated part of the impenetrable part.
3. Packaging according to claim 1, wherein the retainer is a
separate part.
4. Packaging according to claim 3, wherein the separate part is
maintained in the impenetrable part when the infusion set is
released from the packaging.
5. Packaging according to claim 1, wherein a proximal side of the
infusion set is provided with an adhesive.
6. Packaging according to claim 5, wherein the adhesive is covered
with a release layer.
7. Packaging according to claim 6, wherein the release layer
covering the adhesive is at least partly fastened to the
impenetrable part or fastened to a part connected to the
impenetrable part.
8. Packaging according to claim 7, wherein the release layer
comprises a band and that one end of the band is fastened to the
impenetrable part or fastened to a part being connected to the
impenetrable part.
9. Packaging according to claim 7, characterized in that the
release layer comprises at least two bands where one end of each
band is fastened to the impenetrable part or fastened to a part
being connected to the impenetrable part.
10. Packaging according to claim 1, wherein the impenetrable part
is made of a hard material.
11. Packaging according to claim 10, wherein the impenetrable part
comprises polypropylene (PP), polyethylene (PE HD) or PVC.
12. Packaging according to claim 1, wherein the needle hub is
provided with means for retaining a device.
13. Packaging according to claim 1, wherein the needle hub
comprises means for retaining an inserter.
14. Packaging according to 1, wherein the needle hub comprises
means for retaining an inserter when the inserter is advanced
towards the needle hub from a distal side of the needle hub.
15. Packaging according to claim 1, wherein the infusion set is
releasably retained by the retainer formed as an integrated part of
the impenetrable part of the packaging.
16. Packaging according to claim 15, wherein the infusion part
comprises corresponding means which are releasably connected to the
retainer.
17. Packaging according to claim 15, wherein the retainer comprises
walls standing from the impenetrable part at an angle between
-45.degree. and 45.degree. where 0.degree. is orthogonal to a
proximal surface of the impenetrable part.
18. Packaging according to claim 17, wherein the corresponding
means are formed as a cylinder or a truncated cone integrated with
the infusion part.
19. Packaging according to claim 18, wherein the corresponding
means comprise a cylinder or a truncated cone formed by a groove in
the infusion part so that a proximal end of the corresponding means
aligns with a proximal surface of the infusion part.
20. Packaging according to claim 15, wherein the retainer comprises
a relatively soft material the material being penetratable by the
insertion needle and unreleasably connected to the impenetrable
part of the packaging.
21. Packaging according to claim 1, wherein a support part parallel
to a proximal surface of the infusion set is fastened to the
impenetrable part or formed as an integrated part of the
impenetrable part.
22. Packaging according to claim 1 wherein the retainer comprises
an opening for the needle and a support part parallel to a proximal
surface of the infusion set.
23. Packaging according to claim 22, wherein the corresponding
means comprise a cylinder or a truncated cone protruding from the
proximal surface of the infusion part.
24. A method for preparing application of an infusion set
comprising an infusion part and a needle hub the needle hub
comprising an insertion needle, the method comprising: removing a
removable cover of a packaging, the packaging having a support part
for holding the infusion part and the needle hub and an
impenetrable part, the impenetrable part at least partially
surrounding the infusion part and protecting the surroundings from
the insertion needle, fastening a device to the needle hub,
removing the infusion set from the impenetrable part of the
packaging by pulling the device, and placing a proximal end of the
infusion set against the skin of the user.
25. The method according to claim 24, wherein the device is an
inserter and further comprising activating the inserter.
26. A method for preparing application of an infusion set
comprising an infusion part and a needle hub where the needle hub
comprising an insertion needle, the method comprising: removing a
removable cover of a packaging, the packaging having a support part
for holding the infusion part and the needle hub and an
impenetrable part, the impenetrable part at least partially
surrounding the infusion part and protecting the surroundings from
the insertion needle fastening a device to the needle hub, removing
the infusion set from the impenetrable part of the packaging and
removing a release layer covering an adhesive provided on a
proximal side of the infusion set by pulling the device, placing a
proximal end of the infusion set against the skin of the user.
27. The method according to claim 24 wherein the device is
tightened before removing the infusion set from the impenetrable
part of the packaging by pulling the device.
28. The method according to claim 24 wherein the device is
tightened after removing the infusion set from the impenetrable
part of the packaging by pulling the device.
29. The packaging of claim 1, wherein the impenetrable part can not
be penetrated by the insertion needle.
30. The packaging of claim 1, wherein the inpenetratable part is
substantially hemispherically-shaped.
Description
TECHNICAL FIELD
[0001] The present invention relates to a packaging for an infusion
set. An infusion set for intermittent or continuous administration
of a therapeutical substance, such as insulin, comprises an
infusion part having a cannula penetrating the skin of a patient
and a connector which connects the infusion part with a medical
device such as an adaptor for a syringe or an insulin pump. The
insertion of the infusion part will be performed with an insertion
needle which is delivered together with the infusion part under
sterile conditions.
BACKGROUND OF THE INVENTION
[0002] U.S. Pat. No. 5,968,011-A relates to a subcutaneous
low-profile infusion set for administrating a medication or a
therapeutic fluid to a patient. It would be possible to apply this
infusion set according to the present invention.
[0003] U.S. Pat. No. 6,355,021-B1 relates to a medical puncturing
device. This device comprises a rigid needle mounted in a needle
hub (2), and the needle hub comprises a handle part (3) and a
shield part (4). This device could be used to insert an infusion
set as described in U.S. Pat. No. 5,968,011-A.
[0004] US 2003/00130619 A1 relates to an insertion device and an
insertion set. FIGS. 35 to 40 and the corresponding text
([0099]-[0107]) describe an insertion device which could be applied
in connection with the present invention.
DESCRIPTION OF INVENTION
[0005] An object of the invention is to make insertion of an
infusion device easier, more flexible and convenient for the
patient. According to the present invention it is possible to
combine a standard infusion device with for example an inserter for
automatic insertion or a handle for manual insertion as the
inventive packaging assures the stability which is necessary in
order to keep the infusion set and needle hub in position while a
secondary device in the form of a handle or an inserter, chosen by
the patient, is pushed against it and connected to it. When the
packaging is used as a sort of handling device during the insertion
procedure, the contamination of the infusion device is also kept at
a minimum.
[0006] It is not essential whether the secondary device is
connected releasable or unreleasable to the infusion device while
connected to it as both possibilities have their advantages but the
secondary device should form a stronger connection with the
infusion set than the infusion set forms with the packaging
according to the invention in order for the user to remove the
infusion set from the packaging by simply pulling the secondary
device away from the packaging.
[0007] The invention concerns a packaging for an infusion set
comprising an infusion part and a needle hub, where the needle hub
is combined with an insertion needle. The packaging comprises an
impenetrable part protecting the surroundings from the insertion
needle and a removable part which is to be removed by the user
before applying the infusion set wherein the inner surface of the
impenetrable part is provided with means for releasable retaining
at least a part of the infusion set.
[0008] Preferably the proximal side of the infusion set is provided
with an adhesive, and the adhesive can be covered with a release
layer.
[0009] In one embodiment of the invention the release layer
covering the adhesive is partly fastened to the impenetrable part
or fastened to a part being connected to the impenetrable part, an
appropriate release layer for an adhesive sheet material is known
from WO 2004/087240. This will cause the release layer to be
removed when the infusion set and the needle hub is removed from
the packaging. According to this embodiment the release layer can
have the form of a band where one end of the band is fastened to
the impenetrable part or fastened to a part being integrated with
the impenetrable part.
[0010] In one embodiment of the invention the impenetrable part is
made of a hard material. Preferably the impenetrable part is made
of polypropylene (PP), polyethylene (PE HD) or PVC.
[0011] In one embodiment of the invention the needle hub is on its
distal side provided with means for retaining a device. Preferably
the needle hub is provided with means for retaining an inserter.
More preferred the needle hub can take up and retain an inserter
when the inserter is pushed towards the needle hub from the distal
side. An inserter is not shown in the figures but a suitable
inserter is described in US patent application no. 2003/0130619
FIGS. 35-38.
[0012] In a preferred embodiment the infusion set is releasable
retained by the retaining means formed as an integrated part of the
impenetrable part of the packaging. In this embodiment the infusion
part can be provided with corresponding means which are releasable
connected to the retaining means. According to this embodiment the
retaining means can be formed as walls standing from the
impenetrable part in an angle between -45.degree. and 45.degree.
where 0.degree. is orthogonal to the proximal surface of the
impenetrable part, and the corresponding means can be formed as a
cylinder or a truncated cone integrated with the infusion part.
[0013] In a most preferred embodiment the corresponding means
comprise a cylinder or a truncated cone formed by a groove or
recess in the infusion part making it possible for the proximal end
of the corresponding means to be aligned to the proximal surface of
the infusion part.
[0014] In another embodiment the retaining means are formed of a
relatively soft material which material can be penetrated by the
insertion needle and which soft material is connected unreleasable
to the impenetrable part of the packaging.
[0015] In a preferred embodiment a support part parallel to the
proximal surface of the infusion set is fastened to the
impenetrable part or formed as an integrated part of the
impenetrable part.
[0016] In another preferred embodiment the retaining means
comprises an opening for the needle and a support part parallel to
the proximal surface of the infusion set. In this embodiment the
corresponding means can comprise a cylinder or a truncated cone
protruding from the proximal surface of the infusion part.
[0017] The invention also concerns a method of applying an infusion
set comprising an infusion part and a needle hub where the needle
hub is combined with an insertion needle, which method comprises
the following steps: [0018] removing the removable part of the
packaging, [0019] fastening a device to the needle hub, [0020]
removing the infusion set from the impenetrable part of the
packaging by pulling the device, and removing the release layer
covering the adhesive if a release layer is present, [0021] placing
the proximal end of the infusion set pointing against the skin of
the user, [0022] penetrating the skin of the user by the insertion
needle thereby positioning the infusion part, and securing the
infusion set to the skin of the patient, [0023] removing the device
and the needle hub leaving the infusion set in position.
[0024] In a preferred embodiment the method comprises the following
steps: [0025] removing the removable part of the packaging, [0026]
fastening an inserter to the needle hub, [0027] removing the
infusion set from the impenetrable part of the packaging by pulling
the inserter, and removing the release layer covering the adhesive
if a release layer is present, [0028] placing the proximal end of
the infusion set pointing against the skin of the user, [0029]
activating the inserter causing the insertion needle to penetrate
the skin and position the infusion part, [0030] securing the
infusion set to the skin of the patient, [0031] removing the
inserter and the needle hub leaving the infusion set in
position.
[0032] The invention also concerns a method of applying an infusion
set comprising an infusion part and a needle hub where the needle
hub is combined with an insertion needle, which method comprises
the following steps: [0033] removing the removable part of the
packaging, [0034] fastening a device to the needle hub, [0035]
removing the infusion set from the impenetrable part of the
packaging and removing the release layer covering the adhesive by
pulling the device, [0036] placing the proximal end of the infusion
set pointing against the skin of the user, [0037] penetrating the
skin of the user by the insertion needle thereby positioning the
infusion part, and securing the infusion set to the skin of the
patient, [0038] removing the device and the needle hub leaving the
infusion set in position.
[0039] It is possible to tighten or load the inserter/secondary
device both before and after the infusion set has been removed from
the impenetrable part of the packaging by pulling the device.
DESCRIPTION OF THE DRAWINGS
[0040] The invention is explained in greater detail below with
reference to the accompanying drawings showing preferred
embodiments of the inventions.
[0041] FIG. 1a shows a known needle hub.
[0042] FIG. 1b shows the same known needle hub from a different
angle.
[0043] FIG. 2 shows a known needle hub integrated with an infusion
part.
[0044] FIG. 3 shows an embodiment of the invention where a known
needle hub integrated with an infusion part is placed in a
protecting packing.
[0045] FIG. 4 shows a second embodiment of the invention where a
known needle hub integrated with an infusion part is placed in a
protecting packing.
[0046] FIG. 5 shows a third embodiment of the invention where a
known needle hub integrated with an infusion part is placed in a
protecting packing.
[0047] FIG. 6 shows a fourth embodiment of the invention where a
known needle hub integrated with an infusion part is placed in a
protecting packing.
[0048] FIG. 7 shows an embodiment of the invention where a known
needle hub integrated with an infusion part is placed in a
protecting packing provided with a feature for removal of the
release paper.
[0049] FIGS. 8a-8f shows in steps how an embodiment of the
invention is to be used.
[0050] FIG. 9 shows an embodiment of the packaging together with an
inserter just before attachment of the inserter.
[0051] FIG. 10 shows an embodiment of the packaging together with
an inserter just after the inserter has been fastened to the needle
hub.
[0052] FIG. 11 shows an embodiment of the packaging provided with a
preferred opening mechanism.
[0053] FIG. 12 shows an embodiment of the protecting packaging
without needle hub seen from above where the packaging is provided
with legs and a substantially centered protrusion for receiving a
circular center part.
[0054] FIG. 13 shows a first sides view the embodiment of the
packaging shown in FIG. 12.
[0055] FIG. 14 shows a second side view of the embodiment of the
packaging shown in FIG. 12.
[0056] FIG. 15 shows an embodiment of the packaging together with
an infusion device.
[0057] FIG. 16 shows a cross sectional view B-B of the embodiment
shown in FIG. 15.
[0058] FIG. 17 shows an embodiment of the protecting packaging
where the retaining means comprises a separate circular center
part.
[0059] FIG. 18 shows a sectional view of the retaining means of
FIG. 17.
[0060] FIG. 19 shows a side view of the retaining means of FIG.
17.
[0061] FIG. 20 shows an embodiment of where a known needle hub
integrated with an infusion part is removed from a protecting
packaging with a feature for removal of a double spiral release
paper.
[0062] FIGS. 21a and 21b show two embodiments of the invention
where the release paper covering the adhesive layer is formed as a
surface covering the adhesive layer having two extending parts and
a central opening.
DEFINITION OF WORDS
[0063] "Distal side" refers to the side of the device which is
turned away from the patient.
[0064] "Proximal side" refers to the side of the device which is
turned towards the patient, and it will generally be used to
describe the part of the device having a surface actually touching
the patient.
[0065] "Integrated" refers e.g. in the phrase "fastened to a part
being integrated with the impenetrable part" to that the part being
integrated is connected unreleasable to the impenetrable part or
e.g. formed of the same piece of material as the impenetrable part
e.g. by molding
[0066] "A hard material" as e.g. mentioned in claim 6, can resist a
certain pressure without being deformed, at least the impenetrable
part which is made of a hard material should be able to resist
forces experienced within normal handling of the device.
[0067] "A relatively soft material" means that it is possible for
the insertion needle (3) to penetrate the material in contrast to
the hard material.
DESCRIPTION OF EMBODIMENTS
[0068] FIG. 1a shows an embodiment of a needle hub 1 with a rigid
insertion needle 3 and means 14 for retaining a device which could
be either a handle or an inserter. The means 14 in this embodiment
comprise a cylindrical opening which opening can receive a
corresponding form mounted on a handle or an inserter when the
handle/inserter is pushed toward the needle hub 1. This embodiment
of a needle hub is known from U.S. Pat. No. 6,355,021-B1.
[0069] FIG. 1b shows the same needle hub as FIG. 1a seen from the
side.
[0070] FIG. 2 shows and embodiment of the same needle hub 1 as in
FIGS. 1a and 1b combined with an infusion part 2. The infusion part
can be in one piece comprising a soft cannula extending from the
proximal side of the infusion part and a connection in the form of
a tube 4 extending from the distal side of the infusion set. In the
embodiment of FIG. 2 the connection is extending parallel to the
patient's skin. The infusion part can also be a combination of two
pieces, a part holding the cannula and a connector part, where a
cannula is extending from the proximal side of the infusion part
while the connection is extending from a distal side of the
connector part. The infusion part 2 is formed with a center piece 5
on the proximal side. The center piece 5 can be extending
relatively to the proximal surface of the infusion part 2 or the
proximal side of the adhesive 6, as it is shown in FIG. 2, but it
can also be retracted relatively to these surfaces. If the center
piece 5 is retracted it can be formed by a circular groove or
recess in the infusion part 2 surrounding the center piece 5.
[0071] An adhesive layer 6 preferably covered with a release layer
6a is unreleasably fastened to the proximal side of the infusion
part 2. In the embodiment of FIG. 2 the cannula is adjoined to the
insertion needle although the cannula is not actually shown in the
figure.
[0072] FIG. 3 shows a combination comprising a needle hub 1 and an
infusion part 2 in an embodiment of the inventive packaging 7, 8.
The packaging comprises an impenetrable part 7 preferably formed of
a relatively hard plastic such as PP, PE HD or PVC. At least the
impenetrable part 7 should be able to resist forces experienced
within normal handling of the device without being deformed and/or
penetrated by the insertion needle 3. The impenetrable part 7
covers the proximal side of the combination 1, 2 and due to the
chosen material and also due to the *positioning of the needle 3,
as the needle 3 of the needle hub 1 is placed in a certain distance
from the surface of the packaging, the impenetrable part 7 protects
the surroundings from the needle. At least a part of the distal
side of the combination 1, 2 is covered by a removable part 8 which
is at least partly removed by the user before the device is
applied.
[0073] When placed in the packaging the combination 1, 2 is in
contact with a support part 9 which part is fastened to or being a
part of the inner surface of the packaging. The support part 9
could be circular or in the form of one or more beams, and/or it
could be fastened to either a central part reaching towards the
periphery without actually touching the periphery or it could be
fastened to the periphery reaching for the center. The support part
9 can also function as a release layer for the adhesive 6 meaning
that the support part 9 totally or partly protects the adhesive
surface during storage.
[0074] If the support part 9 functions as a release layer it is
important to consider the force needed to overcome the release of
the infusion part 2 from the support part 9 as the infusion part 2
in some degree is fastened to the support part 9 by adhesion. In
order to regulate the attraction between the infusion part 2 and
the support surface 9 and thereby also regulate the force needed to
overcome the release of the infusion part 2, a suitable fraction of
the adhesive 6 surface can be covered by a release layer which has
no attraction to the support surface 9.
[0075] The support part 9 assures that the combination 1, 2 is
positioned in a stable manner.
[0076] In a preferred embodiment the support part 9 has the form of
a number of ribs fastened to or integrated with the walls of the
impenetrable part 7, preferable the ribs are equally distributed
along the inner surface of the impenetrable part 7 in order to
offer maximum support for the infusion set. Also in a preferred
embodiment the periphery of a spiral release layer 6a protecting
the adhesive surface 6 is fastened to the impenetrable part 7 or to
a part integrated with the impenetrable part 7. The spiral release
layer 6a could be fastened to the impenetrable part 7 by gluing,
welding or mechanically.
[0077] In this embodiment of the packaging the needle/cannula of
the combination 1, 2 is placed in a circular center part 7a with
walls standing upright from the inner surface of the impenetrable
part 7. The center piece 5 is squeezed down into the corresponding
circular center part 7a and the friction between the piece 5 and
the walls in the center part 7a keeps the combination 1, 2 in
place.
[0078] In another not shown embodiment means 7a comprises flat
springs fastened to the periphery of the impenetrable part 7 and
pushing down on parts of the infusion part 2 and/or parts of the
needle hub 1. The flat springs can during production be pushed down
over parts of the infusion device 2 and fastened to the periphery
which will keep the combination 1, 2 in place.
[0079] In FIG. 3 the removable part 8 is made of a paper material
e.g. Integra peel medical grade paper or heat seal coated Tyvek,
and the paper material is fastened to the upper edge of the
impenetrable part 7. Before applying the device the user pulls of
the removable part 8 making the combination accessible.
[0080] The connection in form of a tube 4 can be twined around the
combination 1, 2 (not shown in the figures) which makes it possible
to pull out the tube 4 without the tube getting tangled.
[0081] FIG. 4 shows another embodiment of the packaging where the
removable part 8 is in the form of a relatively hard lid. Before
applying the device the user will have to pull of the removable
part 8 making the combination accessible.
[0082] FIG. 5 shows an embodiment comprising a handle for manual
insertion. The handle is formed by integrating the needle hub 1
with the removable part 8, either by creating the two parts as one
or by connecting the two parts in a stable manner.
[0083] FIG. 6 shows an embodiment of the invention where the center
piece 5 is replaced with a material 10 placed inside the circular
center part 7a. In another not shown embodiment the lower part of
the impenetrable part 7 is filled with this material 10, which e.g.
can be silicone, to a height exceeding the length of the needle, in
this embodiment the filling material 10 constitutes the support
part 9. According to this solution the combination 1, 2 is kept in
place by the friction between the needle and the filling material
10.
[0084] FIG. 7 shows an embodiment of the invention where a release
layer 6a covering the adhesive 6 is removed during release of the
combination 1, 2 from the packaging. The release layer 6a is formed
as a spiral band where one end--in this embodiment the end closest
to the periphery--is connected to the support part 9, and the rest
of the release layer 6a is releasably fastened to the adhesive
surface 6.
[0085] The FIGS. 8a to 8f illustrate an embodiment of the invention
and how this embodiment functions during use.
[0086] In FIG. 8a the combination of needle hub 1 and infusion part
2 is placed inside a packaging according to the invention under
sterile conditions, and the impenetrable part 7 protects the
surroundings from contact with the insertion needle 3. The
removable 8 is loosened from the distal edge formed by the
impenetrable part 7 but is not totally removed.
[0087] In FIG. 8b the removable part 8 has been totally removed and
the tube 4 which is connected to the infusion part 2 has been
pulled out of the packaging.
[0088] In FIG. 8c an inserter 11 with a handle 13 has been fastened
to the needle hub 1 by pushing the inserter 11 towards the needle
hub 1 through the opening that was revealed when the removable part
8 was removed. The inserter 11 comprises internal tracks
corresponding to the means 14 of the needle hub 1, and when the
inserter 11 is pushed toward the needle hub 1 in the right angle,
the needle hub 1 will be pressed into the tracks of the inserter 11
causing the needle hub 1 and the inserter 11 to be fastened to each
other.
[0089] In FIG. 8d the tube 4 of the infusion device has been
connected to a medical device 12 which in this embodiment has the
form of an insulin pump.
[0090] In FIG. 8e the inserter 11 has been prepared for insertion
of the infusion set by pulling up the handle 13. The act of pulling
up the handle could also be referred to as "tightening" or
"loading" the inserter as an internal spring in the inserter is
biased by this action. When preparing the inserter 11 the needle
hub 1 and the infusion part 2 is released from the packaging and
placed inside the inserter 11.
[0091] In FIG. 8f the infusion set connected to the inserter 11 is
lifted out of the packaging and it is now ready for inserting the
infusion set. When inserting the infusion set the user places the
proximal end of the inserter 11 against the skin and thereafter the
user activates the inserter 11 and causes the insertion needle 3 to
penetrate the skin of the user. After insertion the inserter 11 is
pulled away, and if the needle hub 1 to which the insertion needle
3 is fastened, is adequately secured to the inserter, the insertion
needle 3 will be removed together with the inserter leaving only
the infusion part 2 on the users skin.
[0092] FIG. 9 shows an embodiment of the packaging 7, 8 together
with an inserter 11 just before the inserter 11 is fastened to the
needle hub 1. In this embodiment the retaining means 7a squeezes
very firmly around corresponding means--the central piece--5. In
order to loosen the strong hold of the central piece 5 the internal
form of the packaging is constructed in such a way that the
pressing the inserter 11 down toward the needle hub 1 forces the
sides of the impenetrable part 7 of packaging outwards.
[0093] FIG. 10 shows the appearance of the impenetrable part 7 of
the packaging after the inserter 11 has been pushed down over the
needle hub 1. The diameter of the upright walls constituting the
retaining means 7a has been extended and a result of this is that
the force needed to pull the center piece 5 out of the retaining
means 7a has been reduced.
[0094] FIG. 11 shows an embodiment of the packaging with means for
easy-opening. The impenetrable part 7 is provided with a top flange
and the removable part 8 which is preferably made in paper, has
been welded to the whole surface of the flange. A line of fracture
15 isolates a corner or a piece of the top flange of the
impenetrable part 7 and when the user opens the packaging the
corner/piece is broken of the top flange and the removable part
which is not provided with a fractured line will be easily removed
by pulling the in the broken off piece which is still welded to the
piece of the removable part 8 covering the piece.
[0095] FIG. 12-14 shows a further embodiment of the packaging from
the outside at three different angles. The impenetrable part 7 has
an upper end which is provided with the removable part 8 and a
lower end positioned opposite the upper end. FIG. 12 shows the
packaging from above, meaning from the upper end of the
impenetrable part 7 of the packaging, where FIGS. 13 and 14 shows
two different side views of the packaging. This embodiment of the
packaging according to FIG. 12-14 shows the impenetrable part 7
being shaped with three legs 7d protruding from the lower surface
of the impenetrable part (7) and a substantially centered shaped
protrusion 7c inside which a separate center part 7b is
positioned.
[0096] FIG. 15 shows an embodiment of the packaging where the
needle/cannula of the combination 1, 2 is placed in the center part
7b. In this embodiment the center part 7b is circular and formed as
a separate part. The center part 7b is placed upright from the
inner surface of the impenetrable part 7 in a correspondingly
shaped protrusion 7c in the impenetrable part 7 of the packaging.
The separate center part 7b is lengthwise provided with a
through-going slit 14, which makes the center part 7b elastic, i.e.
it is possible to vary the dimension of the center part 7b. The
center part 7b is placed in the correspondingly shaped protrusion
7c engaging with the center piece 5 of the impenetrable part 7. As
the center piece 5 engages with the corresponding circular center
part 7b, the center part 7b is expanded and the center part 7b is
fixed in the protrusion 7c. The friction between the center piece 5
and the separate circular center piece 7b placed in the
correspondingly shaped protrusion 7c in the impenetrable part 7
keeps the combination 1, 2 in place. Further, the friction
occurring between the center part 7b and the protrusion 7c keeps
the center part 7b within the protrusion 7b of the packaging, this
friction being larger than the friction between the center piece 7b
and the combination 1, 2.
[0097] In preparing the infusion set for insertion the removable
part 8 is removed from the impenetrable part 7 and the combined
needle hub 1 and infusion part 2 is released from the packaging
either manually or by an inserter 11. In order to loosen the strong
hold of the center piece 5, the form of the separate center part 7b
is constructed in such a way that the pressing of the inserter 11
down toward the needle hub 1 forces the center part 7b to expand
outwards towards the protrusion 7c in the packaging, which is
possible due to the slit which makes to center part 7b elastic.
[0098] FIG. 17-19 shows a circular embodiment of the center part 7b
with a lengthwise through-going slit 14. The circular center part
7b is in this embodiment provided with a circular part 16 having a
smaller diameter than the diameter of the circular center part 7b
via a shoulder part 15 which secures and keeps the center piece 5
in place.
[0099] FIG. 20 shows an embodiment of the invention where a release
layer 6a covering the adhesive 6 is removed during release of the
combination 1, 2 from the packaging. The release layer 6a is in
this embodiment divided into two sections where each section forms
a strip such as a spiral band, thereby forming a double spiral
release layer 6a. The peripheral end 17 of each strip of the
release layer 6a closest to the periphery, only one is shown in the
figure, are connected to the impenetrable part 7 or to a part
integrated with the impenetrable part 7, and the rest of the
release layer 6a is releasable fastened to the adhesive surface 6.
As the above mentioned single spiral release layer 6a, this double
spiral release layer 6a could also be connected or fastened to the
impenetrable part by gluing, welding or mechanically. In this
embodiment, when pressing the inserter 11, not shown in FIG. 20,
down for releasing of the combination 1, 2 from the packaging, the
peripheral end 17 of each strip of the release layer 6a in the form
of a tab are pressed down towards the impenetrable part 7 of the
interior packaging and fastened with glue, said glue being placed
at points corresponding to the tabs 17 within the interior of the
packaging on the impenetrable part 7. When releasing the needle hub
1 and infusion part 2 from the packaging the release layer is then
automatically peeled of the adhesive layer.
[0100] FIG. 21a shows one embodiment of the release layer 6a
covering the adhesive layer, where the release layer 6a is in a
single piece and has two extending peripheral ends 17 in the form
of protruding tabs intended for fastening to the impenetrable part
7 or to a part integrated with the impenetrable part 7.
[0101] FIG. 21b shows another embodiment of the release layer 6a
where the release layer is divided into two sections 6b and 6c,
each section forming a strip such as a spiral band, thereby forming
a double spiral release layer 6a. In this embodiment each extending
peripheral end 17 of each strip of the release layer 6a are also in
the form of protruding tabs 17 intended for fastening to the
impenetrable part 7 or to a part integrated with the impenetrable
part 7. This embodiment is a more suitable form of the release
layer than the form shown in FIG. 21a as the strips defines a more
precise length for the releasing of the release layer. Furthermore,
by a single pull the release layer can be removed from the adhesive
layer in two narrow strips and only little force is needed to
remove it.
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