U.S. patent application number 12/907774 was filed with the patent office on 2011-02-24 for sealing element.
Invention is credited to Joachim Glocker, Walter Schwarz, Udo J. Vetter.
Application Number | 20110046563 12/907774 |
Document ID | / |
Family ID | 7687590 |
Filed Date | 2011-02-24 |
United States Patent
Application |
20110046563 |
Kind Code |
A1 |
Vetter; Udo J. ; et
al. |
February 24, 2011 |
SEALING ELEMENT
Abstract
A sealing element is suggested, in particular one for closing
primary packaging for medications, that has at least two parts,
which touch each other at least in some areas. This is
characterized in that steam-permeable channels are provided for
sterilization of the contact surfaces. In addition, a method is
suggested for manufacturing a syringe system with a sealing
element. This is characterized by the steps preliminary assembly of
the sealing element, sterilization of the sealing element, final
assembly of the sealing element.
Inventors: |
Vetter; Udo J.; (US)
; Glocker; Joachim; (US) ; Schwarz; Walter;
(US) |
Correspondence
Address: |
BATEMAN IP LAW GROUP
4 Triad Center, Suite 825, P.O. Box 1319
Salt Lake City
UT
84110
US
|
Family ID: |
7687590 |
Appl. No.: |
12/907774 |
Filed: |
October 19, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10479206 |
Mar 1, 2004 |
7828777 |
|
|
PCT/EP02/05505 |
May 18, 2002 |
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12907774 |
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Current U.S.
Class: |
604/197 ;
604/199 |
Current CPC
Class: |
A61L 2/20 20130101; A61L
2/26 20130101; A61M 2005/3104 20130101; A61M 5/31511 20130101; A61L
2/18 20130101; A61L 2202/121 20130101; A61L 2/07 20130101; A61L
2202/21 20130101 |
Class at
Publication: |
604/197 ;
604/199 |
International
Class: |
A61M 5/31 20060101
A61M005/31; A61M 5/32 20060101 A61M005/32; A61M 5/315 20060101
A61M005/315 |
Foreign Application Data
Date |
Code |
Application Number |
Jun 1, 2001 |
DE |
10127779.2 |
Claims
1.-27. (canceled)
28. A sealing device for a medicine bearing receptacle comprising:
a sealing cap, the sealing cap being disposed to engage the
receptacle to seal the receptacle and thereby prevent fluid from
entering or exiting the receptacle; and a permeable sterilization
member disposed over the sealing cap, the sterilization member
being formed of a porous material to thereby permit sterilization
fluid to pass therethrough to sterilize the sealing cap.
29. The device of claim 28, wherein the sealing cap has a
projection formed thereon and wherein the sterilization member has
a recess formed therein which engages the projection to secure the
sterilization member to the projection cap.
30. The device of claim 29, wherein the sealing cap has a pair of
recesses and the sterilization member has a pair of recesses.
31. The device of claim 29, wherein the sterilization member
comprises a ring disposed below the recess to engage the
projection.
32. The device of claim 28, wherein the sterilization member forms
a safety cap disposed to cover the sealing cap.
33. The device of claim 28, wherein the medicine bearing receptacle
is a syringe.
34. The device of claim 33, wherein the sealing cap has an inner
chamber shaped to receive the tip of a syringe.
35. The device of claim 33, wherein the sealing cap has an inner
chamber shaped to receive the tip and injection needle of a
syringe.
36. A syringe plunger comprising: a plunger, the plunger being
formed as a sealing sleeve which, when disposed in a syringe body,
seals against the syringe body, the plunger having generally
cylindrical sidewalls and a top portion and defining a recess
therein which is open to a back side of the plunger; a support
element disposed in the recess, the support element allowing
sterilization fluid to pass thereby to sterilize the sidewalls and
top portion of the plunger recess.
37. The device of claim 36, wherein the support element is formed
of a porous material which is permeable to sterilization fluid to
allow sterilization fluid to pass therethrough and sterilize the
plunger recess.
38. The device of claim 36, wherein the support element is movable
between: a preassembly position wherein a space is present between
the support element and the top portion of the plunger and wherein
a slot is present between the support element and the plunger
sidewalls such that a sterilization fluid can pass through the slot
and sterilize the space between the plunger top portion and the
support element; and a final assembly position wherein the support
element is moved against the top portion of the plunger.
39. The device of claim 38, wherein the plunger has a rib formed on
the plunger sidewalls, the rib engaging the support element to
space the support element away from the sidewalls and form the
slot.
40. The device of claim 39, wherein the plunger has three ribs
formed on the plunger sidewalls.
41. The device of claim 39, wherein the rib engages the support
element to hold the support element in the preassembly
position.
42. The device of claim 36, wherein the plunger is formed of a soft
material and wherein the support element is formed of a rigid
material.
Description
RELATED APPLICATIONS
[0001] The present application is a divisional application of U.S.
Ser. No. 10/479,206, filed Mar. 1, 2004, which is expressly
incorporated herein by reference in its entirety, which is the U.S.
National Phase of PCT Application PCT/EP02/05505, filed May 18,
2002, claiming priority to German Patent Application No.
10127779.2, filed Jun. 1, 2001.
BACKGROUND
State of the Art
[0002] The invention relates to a sealing element according to the
preamble of claim 1 and a method for producing a sealing element
according to the preamble of claim 21.
[0003] Sealing elements and methods of the type addressed here are
known. The sealing elements are used as sealing stoppers for
primary packaging, as it is called, for medical purposes,
especially for syringes and cannulas. It has been found that
sealing elements of the type addressed here cannot be optimally
sterilized in all cases: there are areas that cannot be reached
directly by the sterilizing medium in a sterilizing method, e.g.,
during autoclaving, so that proper sterilizing cannot be
ensured.
[0004] Therefore it is the object of the invention to provide a
sealing element and a method for its production, which distinguish
themselves in that an optimum sterilization is possible.
SUMMARY OF THE INVENTION
[0005] To achieve this object, a sealing element is suggested that
comprises the characteristics named in claim 1. It is characterized
in that channels are provided, through which the medium used for
sterilizing, e.g., steam, can be brought to otherwise inaccessible
locations, e.g., to contact surfaces on which parts of the closing
element contact.
[0006] An embodiment of the sealing element is preferred that is
characterized in that a first part is designed as a sterilization
element. In this case, it is an element that is permeable by the
sterilizing medium, which conducts this medium into areas that
would otherwise be inaccessible for sterilization.
[0007] Another preferred embodiment example is characterized in
that the sterilizing medium is guided into the inside of the
sterilization element, i.e., that the channels run through this
element. The sealing element is thus characterized by a simple
structure.
[0008] Another preferred embodiment example is characterized in
that the sterilization element is designed as a clamping element.
In this way it is possible to optimally sterilize the sealing
element and on the other hand, to ensure that with a simple
structure a clamping of the sealing element, e.g., on a syringe
body, is possible in a simple way.
[0009] Another preferred embodiment of the sealing element is
distinguished in that the channels are used for guiding the
sterilizing medium between two parts that comprise the sealing
element. The parts are provided with projections and/or recesses in
the contact area so that the sterilizing medium can be guided
between the two parts, i.e., in the contact area.
[0010] An especially preferred embodiment of the sealing element is
characterized in that the sterilization element forms a supporting
element. It increases the mechanical strength of the sealing
element in such a way that it can be used in connection with
application aids, e.g., with motor-driven infusion and/or injection
pumps without there being any malfunctions because the sealing
element has elasticity that is too high.
[0011] Other advantages will be seen from the remaining
subclaims.
[0012] To achieve the object of the invention, a method is also
suggested for producing an injection system with a sealing element
that has the characteristics named in claim 21 and is characterized
in that the sealing element is preassembled first. This means, the
parts of the sealing element are brought into the initial position,
in which the later contact surfaces of the sealing element are
still accessible to a sterilizing medium. In a next step, the
sterilization is carried out. Finally, the parts of the sealing
element are moved into their final positions in a final assembly
step. The contact surfaces that are now formed are effectively
cleaned in the preceding sterilization step, so that no
contamination can result.
[0013] Especially preferred is an embodiment of the method that
comprises the characteristics named in claim 26 and is
characterized in that the sealing element is transferred to a
syringe system by way of an autoclave of a filling device that is
used as a sluice. Thus on one hand, the autoclave makes possible
the sterilizing of the sealing element possible and on the other,
is used to move sealing elements from a room that does not have
aseptic conditions to another room that is subject to aseptic clean
room connections.
[0014] Other embodiments of the method can be seen from the
subclaims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The invention is described in more detail in the following
using the drawings. They show:
[0016] FIG. 1 shows a cross-section of a first embodiment example
of a two-part sealing element;
[0017] FIG. 2 shows a cross-section through a second embodiment
example of a preassembled two-part sealing element;
[0018] FIG. 3 shows a top view on the open side of the sealing
element shown in FIG. 2;
[0019] FIG. 4 shows a cross-section through the sealing element
shown in FIG. 2 in assembled condition;
[0020] FIG. 5 shows a cross-section of another embodiment example
with outer support elements;
[0021] FIG. 6 shows a cross-section through a three-part sealing
element with a coupling system and a device for fluid guiding;
[0022] FIG. 7 shows a cross-section through another embodiment
example of a sealing element with a safety cap;
[0023] FIG. 8 shows a cross-section through another embodiment
example of a sealing element with a filtering device;
[0024] FIGS. 9 and 10 show a cross-section through other
embodiments of the sealing element.
DETAILED DESCRIPTION
[0025] FIG. 1 shows a sealing element 1 that consists of a support
element 3 with stable shape and an elastically deformable sealing
sleeve 5. The support element 3 and the sealing sleeve 5 are
designed as cylindrical rotation elements. The sealing sleeve 5 is
designed in such a way that it is in contact with the majority of
the surface of support element 3, i.e., at least partially
surrounds it. The sealing sleeve 5 has, on the inside, a
surrounding step 7, 7' that is also in contact with support element
3. Because of the elasticity of the sealing sleeve 5 and the step
7, into which the support element 3 can engage, the support element
3 is held securely.
[0026] Support element 3 is also characterized in that it has
higher strength than the sealing sleeve 5. Thus it is used to
stabilize the sealing element 1, in particular in the sense that
the total elasticity of sealing element 1 is reduced, i.e., it is
less compressible. Preferably the support element 3 is designed in
such a way that it practically cannot be compressed.
[0027] With areas of its outer surface, support element 3 contacts
the inside of sealing sleeve 5 so that these two parts form a
common contact surface. In order to be able to sterilize the
contact surface completely during a sterilizing procedure, it is
provided that at least one of the parts of sealing element 1 has
channels through which steam can pass, through which the
sterilization medium can penetrate to the contact surface. For
example, the support element 3 can be provided at least with
channels permeable to steam. In the embodiment example shown here,
the support element 3 is provided with structures that are
permeable to steam, which are identified by honeycomb shading. In
this case, it is preferably provided that the entire support
element is provided with such a structure permeable to steam.
Because of this, it can be ensured that when the sealing element 1
is exposed, steam can get through the entire support element 3 into
the area of the contact surface with the sealing sleeve 5. This
makes possible sterilization of all surfaces, i.e., even of the
surfaces with which the support element 3 and the sealing sleeve 5
are in contact, in one work sequence.
[0028] The embodiment example shown is designed as a rotation
element and is preferably used to seal a cylindrical tube that is
not shown here, namely of a syringe body. The outside of sealing
sleeve 5 has beads 9, 11, 13 around it. To seal the cylindrical
tube, sealing element 1 is installed in it. In this way, the beads
9, 11, 13 come into contact with the inside surface of the
cylindrical tube and in this process, form three surrounding
sealing lips. In this way, sealing element 1 is installed in the
cylindrical tube in such a way that its upper surface 15 forms a
tightly closed interior space together with the inside wall of the
tubes, i.e., of the syringe body, in which a fluid, especially a
fluid medication and/or nutritional solution, etc. can be tightly
enclosed in it. It can be seen that any excess pressure of the
fluid that acts on the upper surface 15 of sealing sleeve 5 can be
absorbed by the support element 3 lying behind it. In this way, an
unintended deformation of sealing sleeve 5 is prevented because of
the support effect of support element 3.
[0029] During a movement of the sealing element 1 in the inside of
the tube and/or of a syringe body, a force is exerted on the side
of support element 3 turned away from the surface 15 of sealing
sleeve 5. Because of this, the sealing element 1 is displaced in
the tube--upward in FIG. 1. It is clear that the thickness of the
walls of sealing sleeve 5 is relatively small in the area of the
upper surface 15, that forces exerted by a piston on the support
element 3 are indirectly exerted on the fluid that is present in
the closed chamber of the syringe. This means that during a
displacement of sealing element 1, only a small deformation of
sealing sleeve 5 can be caused due to the small wall thickness over
the support element 3. Thus if a piston is slid into the inside of
a syringe body by a specific movement path to move the sealing
element 1, an amount of fluid that can be determined very precisely
can be removed from the syringe. This is especially true if the
elasticity of support element 3 is significantly lower than that of
sealing sleeve 5.
[0030] On a sealing element 1 installed in a cylindrical tube, the
inside diameter of which is slightly smaller than the outer
diameter of the first bead 9, a sealing force develops between the
first bead 9 and the inner cylinder wall that is indicated here by
an arrow 17. It can be seen that this force required for the
sealing effect is also absorbed by the support element 3 lying
directly behind it. This means both the sealing force, as well as
the forces caused by any excess pressure of the fluid to be sealed,
are absorbed by support element 3. The beads 11, 13 are no longer
stressed with sealing forces that are as high as the first bead 9;
they are used to capture any leakage that may occur, which could
develop at the first bead 9.
[0031] Support element 3 is thus arranged on the inside of sealing
sleeve 5 in such a way that all significant forces that act on
sealing sleeve 5 can be securely absorbed by support element 3. The
sealing sleeve 5 can consist of a material that is optimum for the
desired sealing of the inner chamber of the syringe body, but is
also relatively soft. However, in the interaction with the stable
support element 3, it acts like a significantly more rigid
component and is thus effectively protected against undesired
deformations by the forces acting on sealing sleeve 5.
[0032] FIG. 2 shows a second embodiment example of the sealing
element, also designed as a rotation element. Common parts are
provided with the same reference numbers so reference is also made
to the description of FIG. 1.
[0033] The important difference from the preceding embodiment lies
in that support element 3' does not have any steam-permeable
structures. Support element 3' is shown in a first pre-assembly
position. Sealing sleeve 5 has a recess 19 that is essentially
cylindrical, the diameter of which is greater than that of the
outer diameter of support element 3'. The inside surface 35 of
recess 19 has at least two, preferably three, ribs of which rib 21
can be seen in cross-section here. The ribs surround an imaginary
inner circle, the inner diameter of which corresponds approximately
to the outer diameter of support element 3'. In this way, the ribs
can form a holding device: they contact the outer surface of
support element 3' with a certain prestress in such a way that it
is securely held in the first preassembly position. The ribs hold
support element 3' at a distance from inner surface 35 of sealing
sleeve 5. Since in this way, the recess 19 on the inside of sealing
sleeve 5 has an inner diameter that is larger than the outer
diameter of support element 3, a slot 23 is formed that runs in the
direction of ribs 21, which separates the ribs from each other in
longitudinal direction. These slots thus form channels through
which a sterilizing medium can go past the sides of support element
3' into the chamber inside the sealing sleeve 5, which is arranged
above support element 3'. Because of this, the entire recess 19 of
sealing sleeve 5 and the complete outer surface of support element
3' can be sterilized. So, for example, if hot steam is used for
sterilizing, which is indicated here by shading, all the inner and
outer surfaces of the sealing sleeve 5 and all surfaces of support
element 3' can be reached and thus sterilized.
[0034] It can also be seen from FIG. 2 that the recess 19 is
limited at the top by a contact surface 25, whose contour is
adapted to the upper contour and thus the contact surface 27 of
support element 3'. In the upper range of recess 19, there is a
surrounding contact surface 29 that cooperates with a surrounding
contact surface 31 of support element 3' when this is moved from
the preassembly position shown in FIG. 2 into its later final
assembly position, which will be discussed in more detail below. In
addition, it can be seen in FIG. 2 that the upper end 33 of rib 21,
which is shown in cross-section here, forms a latching device that
holds support element 3' sealed in a locked manner when it is moved
into its final assembly position.
[0035] FIG. 3 shows a bottom view in recess 19 of the sealing
element 1 shown in FIG. 2. The sealing sleeve 5 and the recess 19
with ribs 21, 21', 21'' can be seen. These are in contact with
support element 3', which is thereby securely held in the first
preassembly position. In addition, the surrounding slot 23 that is
only interrupted by ribs 21, 21', 21'' can also be seen, which is
shown here as a dotted line. Because of the slot 23 that is formed
by the surrounding contact surface 31 of support element 3' and the
inside surface 35 of the sealing sleeve 5, hot steam provided for
sterilizing can flow through. In this way, it is ensured that the
entire sealing element can be autoclaved, i.e., sterilized, in the
preassembled condition. The holding force on ribs 21, 21', 21''
necessary for securely holding the support element 3' are applied
by the inherent elasticity of the sealing sleeve 5'.
[0036] FIG. 4 shows the same view as FIG. 2 again with the
difference that support element 3' is located in a second final
assembly position. Common parts are provided with the same
reference numbers, so reference is made to the description of the
preceding figures. What can be seen is that the contact surfaces 25
to 31 explained in FIG. 2 are now in contact with each other. Arrow
37 indicates that the support element 3' is slid, by means of a
suitable device, far enough in the direction of arrow 37 until it
engages in the final position. How the support element 3' engages
at the upper ends 33 and 33' of ribs 21, 21', 21'' can be
recognized. Support element 3' is thereby held securely against the
contact surfaces 25 to 31 by residual forces, adhesion forces and
frictional forces. The forces necessary for the friction are
applied, in particular, by the inherent elasticity of sealing
sleeve 5.
[0037] In assembled and installed condition, sealing element 1 can
be slid along arrow 37 in a syringe body in a known way by means of
a piston, which exerts forces acting on the support element 3' in
the direction of arrow 37. Because of this, a fluid located in a
cylindrical tube is exposed to overpressure that can be utilized
for metered emptying of the cylindrical tube. In particular, this
involves syringes or cannulas for injection of fluid medications
and/or nutritional solutions, etc. In this process, a precise
metering of the injection quantity is especially important, above
all in automatic injection devices. In this process, precise
metering is carried out by selective sliding of sealing element 1
in the direction of arrow 37. The force necessary for sliding the
sealing element 1 thereby acts advantageously on the lower surface
39 of support element 3' in the direction of arrow 37. This force
is transferred directly by way of the support element 3', over the
upper contact surfaces 25 and 27 onto the sealing sleeve 5. It is
also clear from this that, because of the transmission of force
over a large surface and the forming effect of support element 3',
an undesired deformation of the sealing sleeve 5 is practically
precluded. This means that, by a sliding of the sealing element 1
by means of a force in the direction of arrow 37 a cylindrical tube
that has a second opening, especially a syringe or cannula, can be
emptied with precise metering, especially for medical injection of
fluid medications and/or nutritional solutions, etc.
[0038] FIG. 4 shows that any forces of a fluid enclosed in a tube
and/or in a syringe body on the upper surface 15 of sealing sleeve
5 and sealing forces that occur that are indicated by arrow 17, can
be absorbed by support element 3' arranged on the inside of sealing
element 1.
[0039] The embodiments of the sealing element 1 shown here as
rotation elements are in no way binding. This means that the
principle of an elastic sealing sleeve with a support element can
be implemented in any type of tube and/or syringe body, e.g., in
oval, polygonal tubes and also in tubes with optionally selected
cross-section surfaces.
[0040] FIG. 5 shows another embodiment example of a sealing element
1 that comprises two parts, namely a sealing cap 41 that is
designed so that it is hollow in its lower area in FIG. 5 and
comprises an inner chamber 43 into which the tip of a syringe can
be introduced, together with an injection needle. This can be
inserted into the base element of the sealing cap 41 when the
sealing element 1 is placed on the syringe that is not shown
here.
[0041] Sealing cap 41 is surrounded by a safety cap 45 that can be
slipped over sealing cap 41. In the lower area of sealing cap 41,
i.e., in the area of inner chamber 43, safety cap 45 is provided
with recesses 47 that extend into the projections 49 of sealing cap
41. The recesses 47 are thus used as sight glasses.
[0042] Safety cap 45 continues downward into a ring 51, which
surrounds the lower edge of sealing cap 41 and engages under
projections 49 in such a way that when tensile forces are exercised
on the safety cap 45, the sealing cap 41 of the sealing element 1
is pulled off the syringe.
[0043] Safety cap 45 stabilizes sealing cap 41 and thus is used as
a support element 3' of the sealing element 1. Sealing cap 41 fills
the inner chamber of safety cap 45 practically completely. Contact
surfaces thus result between the inner surface of safety cap 45 and
the outer surface of sealing cap 41. In order to ensure that the
contamination present in the area of the contact surface can be
deactivated, safety cap 45 is provided at least with channels that
penetrate the walls of safety cap 45 and lead to the area of the
contact surface. Preferably, the safety cap 45 is completely
manufactured of a porous material that corresponds to that of the
support element, which was described using FIGS. 1 to 4. For
example, in this case, as there, a sinter-like material can be used
to manufacture the support element. If sealing element 1 that is
shown in FIG. 5 is brought into a sterilizing medium, e.g., exposed
to hot steam, this medium can securely reach the outer surface of
the safety cap 45, the inner chamber 43 of sealing cap 41, but also
the contact surface between the two parts, since the material of
safety cap 45 is permeable to steam, i.e., permeable to the
sterilizing medium. It is also conceivable to manufacture sealing
cap 41 with channels, porous structures or completely of porous
material in order to be able to carry out a sterilization in the
contact area and/or in the area of the contact surface. However, in
the embodiment example shown in FIG. 5, channels can also lead into
the area of the contact surface, as was explained with reference to
FIGS. 2 and 3 in order to be able to carry out a sterilization.
[0044] The cross-section diagram according to FIG. 6 shows another
embodiment example of a sealing element 1 that comprises a sealing
cap 41. This is mounted on a conical projection 53 of a clamping
element 55, on which if necessary an injection needle can also be
mounted. The clamping element 55 has a cylindrical shroud 57 that
engages the end area of a cylindrical tube and/or a syringe body,
but this is not shown here. In the lower end area of shroud 57
turned away from sealing cap 41, projections serving as hooks 59
are provided on the inside of the shroud, which on the outside
engage with the tube and/or syringe body in a locking manner in
order to securely anchor the clamping element 55 on the tube and/or
syringe body. On the inside of clamping element 55, a sealing
stopper 61 is provided that closes and seals the end area of the
tube and/or the syringe body and extends into the conical
projection 53. Sealing stopper 61 has a central channel 63 that is
tightly closed by sealing stopper 61.
[0045] The cross-section diagram according to FIG. 6 shows that the
parts of sealing element 1, in this case the sealing cap 41 and the
sealing stopper 61 do not engage with each other directly, i.e., do
not contact each other directly. The clamping element 55, which can
have channels or porous structures, is found in the contact area
between the two parts. It is provided here that the entire clamping
element 55 consists of a porous, possibly sinter-like material. In
this way it is possible to reach the otherwise inaccessible area
between the parts of the sealing element 1 in an autoclaving and/or
sterilizing process and deactivate contamination. Clamping element
55 thus acts as a sterilization element. It makes possible the
entry of the sterilizing medium into the area in which the sealing
cap 41 contacts the clamping element 55 and the clamping element 55
contacts sealing stopper 61. Since the sterilizing medium can
access sealing element 1 from the inside and from the outside, it
can be sterilized completely.
[0046] The embodiment example of a sealing element 1 shown in FIG.
7 is basically set up as was shown in FIG. 6: it comprises a
sealing cap 41, a clamping element 55 serving as the sterilization
element and a sealing stopper 61 which, as in the embodiment
example according to FIG. 6, is mounted on the inside of clamping
element 55 and is used to seal a tube and/or a syringe body on
which the clamping element 55 is mounted in the end area. Because
of the clamping element 55 lying between sealing cap 41 and sealing
stopper 61, which here consists e.g., completely of porous
material, a sterilization of the area enclosed by the two sealing
elements is thus possible. The clamping element 55 has a
cylindrical projection 65 surrounding the conical projection 53,
which can be provided with an internal thread 67 on its inside.
This is used to securely hold a cannula mounted on the conical
projection 53 and anchor it on clamping element 55.
[0047] In addition, a safety cap 45 is also provided here that
engages over the sealing cap 41 and ensures that it cannot be
damaged or unintentionally removed from the sealing element 1
assembly. Safety cap 45 surrounds the cylindrical projection 65 and
is anchored on it so that it locks. A designated breaking point 69
is indicated by a gap: if a force is exerted on safety cap 45, the
upper part of same will be broken off so that the sealing cap 41 is
accessible and removable. A user can thus see, with no problem,
whether any non-permitted manipulations have been carried out on
sealing element 1. The safety cap 45 thus represents a so-called
original seal or a guaranteed seal.
[0048] In the embodiment example shown here, safety cap 45 is
provided with channels or with porous structures in order to be
able to reach the outer surface of sealing cap 41 in a sterilizing
procedure. It is also conceivable to manufacture the entire safety
cap 45 of a porous material as shown in FIG. 7.
[0049] From the explanation of FIG. 7, it is clear that in the
embodiment example shown here, as in the embodiment example
according to FIG. 6, the clamping element 55 serves as a
sterilization element, but also to stabilize the sealing element 1
itself. The fact that the clamping element 55 ultimately also
serves as a support element of sealing element 1 is thus
achieved.
[0050] FIG. 8 shows a further embodiment example of a sealing
element 1 that essentially corresponds to the one that was
explained in FIG. 7. Common parts are thus provided with the same
reference numbers. However, in the illustration according to FIG.
8, the safety cap 45 is not mounted. In contrast to the embodiment
examples previously described, in the area of the passage channel
63 of sealing stopper 61, a filter device 71 is provided that has a
filter 73, fastened by a bracket 75, in the flow path of the medium
that comes out of the tube and/or the syringe body. In this case
bracket 75 is formed by a ring, which itself consists of porous
material so that its contact surfaces against sealing stopper 61
can be sterilized. The ring of bracket 75 is shown here as a
separate element. However, it is also possible for the bracket 75
to be a part of clamping element 55. The ring extends far enough
into sealing stopper 61 so that is serves as a support element for
sealing stopper 61 and ensures that the sealing stopper is pressed
against the tube and/or a syringe body so that it seals when the
sealing element 1 is mounted.
[0051] Purely by way of example, the embodiment shown in FIG. 8 is
provided with a cylindrical projection 65 that surrounds the
conical projection 53 and is provided with an internal thread
67.
[0052] FIG. 8 also shows that the clamping element 55 that serves
as a sterilization element extends into the inside of sealing cap
41 in such a way that the cap is stabilized. The clamping element
also acts as a support element here.
[0053] FIGS. 9 and 10 again show embodiment examples of sealing
elements, but here with the upper part of a syringe body 77 that
has a conical projection 53', on which a cannula can be mounted. In
the embodiment examples shown in FIG. 9, the sealing element 1 is
designed similarly to the embodiment shown in FIG. 5: the sealing
element 1 has a sealing cap 41 that is surrounded by a safety cap
45. The height of the safety cap 45 is selected in such a way that
it extends downward over sealing cap 41 far enough that a holding
ring 79 can be provided on the lower edge of safety cap 45, this
holding ring 77 engaging in a corresponding recess 81 that runs on
the outer surface of the syringe body and thus anchoring the safety
cap 45 on syringe body 77. A surrounding specified breakage point
69 is indicated by a gap in FIG. 9. If a force is exerted on safety
cap 45, its upper part with sealing cap 41 breaks off. The lower
edge remains on syringe body 77 with the holding ring 79.
[0054] Because of the specified breaking point 69, a sterilizing
medium can get into the inside of safety cap 45 and sterilize both
the outer surface of conical projection 53' and of holding ring 79.
It is provided here that the safety cap 45 is manufactured
completely of porous material in order to make the contact surface
between sealing cap 41 and safety cap 45 accessible to the
sterilizing medium. However, it would basically be adequate to
provide channels or porous structures here in order to make the
contact surface accessible. Ultimately it is also conceivable to
provide projections and recesses here to form channels in the
contact area between the two parts of sealing element in order to
permit sterilization of the contact surface. This has already been
explained with FIGS. 2 to 4 for another embodiment example.
However, this basic principle can be transferred to the embodiment
example shown in FIG. 9 with no problems.
[0055] In turn, it can be seen from the diagram according to FIG.
9, that the safety cap 45 also serves for stabilizing the sealing
cap 41 and presses this to seal it against the outer surface of the
conical projection 53'. In this way, safety cap 45 also exhibits
the function of a support element.
[0056] The cross-section drawing according to FIG. 10 shows a
modified embodiment example of a sealing element 1. It has a
sealing cap 41 that, as already described, can be mounted on the
conical projection 53' of an syringe body 77. The sealing element
also comprises a clamping element 55 that engages on the outside
with syringe body 77 and/or in the lower area of the conical
projection 53' and holds the sealing element 1. The clamping
element 55 has a cylindrical projection 65 with an internal thread
67 that is used to securely hold a cannula mounted on the conical
projection 53'.
[0057] On the outside, on clamping element 55 a safety cap 45 is
mounted that engages on the outside of clamping element 55 with a
sealing tab 81 and stresses the sealing cap 41. In the shroud
surface of safety cap 45 there are recesses 47, into which the
projections 49 of the sealing cap 41 engage. The recesses 47 serve,
on one hand, as sight glasses and on the other, they offer contact
shoulders for projections 49 so that the sealing cap 41, together
with the safety cap 45, can be taken off the syringe body 77. A
surrounding specified breaking point 69 is also indicated here by a
gap, which is used to implement an original seal and leads to the
fact that the upper part of the safety cap 45 breaks off if
appropriately high forces are exerted. With the part of safety cap
45 that is broken off, the sealing cap 41 of sealing element 1 is
then taken off the syringe body 77 so that the conical projection
53' is freely accessible.
[0058] In the embodiment example shown here, both the clamping
element 55 and the safety cap 45 are manufactured of porous
material, which ensures that the contact surfaces of the parts of
sealing element 1 can securely be reached in a sterilizing
procedure: on one hand, the contact area between safety cap 45 and
clamping element 55 is safety sterilized and on the other, all
contact surfaces between safety cap 45 and sealing cap 41 are.
[0059] Depending on the design of safety cap 45, this can also be
used to stabilize the sealing cap 41. In this way, a support
element can also be implemented for sealing element 1.
[0060] The following becomes clear from the explanations of FIGS. 1
to 10:
[0061] The sealing element is designed in such a way that contact
areas and/or contact surfaces between the individual parts of the
sealing element are accessible in a sterilizing procedure. This is
possible in that an entire part provided with channels, porous
structures, etc. is manufactured completely of a porous material.
This was explained in more detail using the support element that is
shown in FIG. 1. It is also conceivable that the contact areas
between parts of the sealing element 1 can be provided with
projections and/or recesses in order to form channels in the area
of the contact surface, through which the sterilizing medium can
flow. This was explained in detail with reference to FIGS. 3 to 4.
The sealing element is thus characterized in that contact surfaces
can be reached directly by sterilizing media. It is also
conceivable that two parts, e.g., in this case a sealing cap 41 and
a sealing stopper 61 do not contact each other directly, but
contact a sterilizing element lying between them. In the embodiment
examples shown here, the sterilization element was simultaneously
designed as clamping element 55. It is also conceivable that in
this case a stabilizing function is also taken over.
[0062] If a support element is provided in a sealing element, as
was described with reference to FIGS. 1 to 4, the sealing element 1
can be used, in particular in connection with syringe systems in
which the sealing element is provided with a suitable drive and
stressed with pressure forces by way of a piston. The automatic
systems are generally designed in such a way that if there are any
irregularities, which in particular are based on undesirable
elasticity of the sealing element, an automatic shutoff occurs.
Because of the stabilizing of the sealing element by the support
element, this type of malfunction can be prevented with a high
degree of safety.
[0063] It has also been shown that with the use of a sterilization
element, these different functions can be undertaken. It can serve
as a clamping element for fastening the sealing element on a
syringe body, but also to hold a cannula securely on a conical
projection of the clamping element or on the conical projection of
a syringe body.
[0064] In all cases, the sealing element has a simple design and
because of this can be safely used in other areas of medicine, in
that complete sterilizing of the given contact surfaces of parts of
the sealing element is ensured.
[0065] The support element explained in FIGS. 1 to 4 is
characterized by a significantly higher rigidity than is present in
the sealing sleeve. However, in the other embodiment examples
explained here, outstanding sterilization safety can be achieved,
and in addition a very high stability of the sealing element, with
the help of the sterilization element that is designed as a
clamping element and/or as a safety cap.
[0066] In the following, the method for manufacturing a syringe
system with a sealing element 1 will be discussed in more detail.
At first, reference is made to FIGS. 2 to 4.
[0067] Sealing element 1 is manufactured in several procedural
steps: first a support element 3 is brought into a first assembly
position on the inside of a sealing sleeve 5. In this position, the
support element 3 is fastened by a holding device that is created
by ribs 21, 21' and 21''. The ribs hold the support element 3' at a
distance from the inner surface of the sealing sleeve 5, so that a
sterilization medium can be brought through the intermediate space
into the inside of the sealing sleeve so that the later contact
surfaces between the inner chamber of sealing sleeve 5 and the
support element 3' can be sterilized.
[0068] After the sterilization, support element 3' is moved into
its final position, which is shown in FIG. 4. In this position, it
is fastened by the end areas of the ribs that serve as latching
tabs.
[0069] The sterilization of the contact surface between two parts
of a sealing element 1 can also be carried out with other
embodiment examples.
[0070] Preferably the sterilization takes place in an autoclave
that can also serve as a sluice, through which the sealing element
is supplied to a filler device, in which a syringe can be filled
with a medication and/or nutritional solution, etc. If necessary,
the syringe can also be filled more after the sealing element is
mounted, by moving it.
* * * * *