U.S. patent application number 13/652722 was filed with the patent office on 2013-04-25 for infusion tube system and method for manufacture.
This patent application is currently assigned to Unomedical A/S. The applicant listed for this patent is Unomedical A/S. Invention is credited to Jacob Andersen, Peter FRUENLUND.
Application Number | 20130103002 13/652722 |
Document ID | / |
Family ID | 44862593 |
Filed Date | 2013-04-25 |
United States Patent
Application |
20130103002 |
Kind Code |
A1 |
FRUENLUND; Peter ; et
al. |
April 25, 2013 |
Infusion Tube System and Method for Manufacture
Abstract
An infusion tube system and a method for manufacture are
provided. An infusion tube system including an infusion tube and a
connector attached to the infusion tube at an end of the infusion
tube is disclosed. The connector has a proximal end and includes a
connector body extending from a distal end to a proximal end along
a center axis and defining a cavity. The connector body includes an
end wall with an inner surface, and at least one vent opening, and
a sidewall extending from the end wall along the center axis with
an inner and outer surface. The connector includes a membrane
covering the at least one vent opening, the membrane being welded
to the inner surface of the end wall along at least one welding
seam including a first welding seam such that the membrane covers
and seals the at least one vent opening.
Inventors: |
FRUENLUND; Peter; (Solrod,
DK) ; Andersen; Jacob; (Naestved, DK) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Unomedical A/S; |
Birkerod |
|
DK |
|
|
Assignee: |
Unomedical A/S
Birkerod
DK
|
Family ID: |
44862593 |
Appl. No.: |
13/652722 |
Filed: |
October 16, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61548871 |
Oct 19, 2011 |
|
|
|
Current U.S.
Class: |
604/533 ; 156/60;
156/73.1 |
Current CPC
Class: |
Y10T 156/10 20150115;
A61M 5/385 20130101; A61M 39/10 20130101; A61M 2207/00 20130101;
A61M 2039/205 20130101 |
Class at
Publication: |
604/533 ; 156/60;
156/73.1 |
International
Class: |
A61M 39/10 20060101
A61M039/10; B32B 37/10 20060101 B32B037/10; B32B 37/06 20060101
B32B037/06 |
Foreign Application Data
Date |
Code |
Application Number |
Oct 19, 2011 |
EP |
11185747.0 |
Claims
1. An infusion tube system comprising an infusion tube and a
connector attached to the infusion tube at an end of the infusion
tube, the connector having a proximal end and comprising a
connector body extending from a distal end to a proximal end along
a center axis and defining a cavity, the connector body comprising
an end wall with an inner surface, and at least one vent opening
including a first vent opening, and a sidewall extending from the
end wall along the center axis with an inner and outer surface,
wherein the connector comprises a membrane covering the at least
one vent opening, the membrane being welded to the inner surface of
the end wall along at least one welding seam including a first
welding seam such that the membrane covers and seals the at least
one vent opening.
2. The infusion tube system according to claim 1, wherein the first
welding seam forms a closed curve surrounding at least the first
vent opening.
3. The infusion tube system according to claim 1, wherein the at
least one welding seam comprises a second welding seam forming a
closed curve surrounding a fluid path opening in the end wall.
4. The infusion tube system according to claim 3, wherein the first
welding seam forms a closed outer welding seam and wherein the
second welding seam forms a dosed inner welding seam surrounded by
the outer welding seam, wherein the membrane area between the inner
welding seam and the outer welding seam covers at least the first
vent opening.
5. The infusion tube system according to claim 1, wherein the
welding area of the at least one welding seam is less than 95% of
the common area between the membrane and the inner surface of the
end wall.
6. The infusion tube system according to claim 1, wherein the
connector comprises a hollow connector needle attached to the
connector body and extending from the inner surface of the end wall
into the cavity.
7. The infusion tube system according to claim 1, wherein the
connector comprises at least one annular protrusion including a
first annular protrusion on the inner surface of the end wall, the
first annular protrusion surrounding at least the first vent
opening, wherein the membrane is welded to the inner surface of the
end wall along the first annular protrusion.
8. The infusion tube system according to claim 1, wherein the at
least one vent opening in the end wall comprises a second vent
opening covered and sealed by the membrane.
9. The infusion tube system according to claim 1, wherein a welding
seam has a width in the range from 0.1 mm to 3 mm.
10. The infusion tube system according to claim 1, wherein the
connector comprises a support structure extending from the end wall
in a proximal direction, the support structure defining a cavity
accommodating at least a part of the infusion tube.
11. A method for manufacturing an infusion tube system comprising
an infusion tube and a connector, the method comprising: providing
a connector with a connector body extending from a distal end to a
proximal end along a center axis and defining a cavity, the
connector body comprising an end wall with an inner surface, and at
least one vent opening including a first vent opening, and a
sidewall extending from the end wall along the center axis with an
inner and outer surface; providing a membrane at the inner surface
of the end wall; and welding the membrane to the inner surface of
the end wall along at least one welding seam including a first
welding seam such that the membrane covers and seals the at least
one vent opening.
12. The method according to claim 11, wherein welding the membrane
to the inner surface is performed with ultrasonic welding.
13. The method according to claim 11, wherein welding a membrane to
the inner surface of the end wall along at least one welding seam
comprises pressing the membrane between the connector body and a
weld horn comprising at least one annular weld protrusion forming
at least one welding seam.
14. The method according to claim 11, wherein the connector
comprises at least one annular protrusion including a first annular
protrusion on the inner surface of the end wall and surrounding at
least the first vent opening, and wherein welding the membrane
comprises welding the membrane along the first annular protrusion.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/548,871, filed Oct. 19, 2011, and European
Application 11185747.0, filed Oct. 19, 2011, which are incorporated
by reference herein in their entirety.
TECHNICAL HELD
[0002] The present invention relates to an infusion tube system and
a method for manufacture of an infusion tube system, in particular
an infusion tube system for coupling to an infusion port of an
infusion device.
BACKGROUND
[0003] Present tube systems, in particular tube systems for
infusion, comprise a tube and a connector attached to an end of the
tube in order to couple the tube to other devices, such as an
infusion device or an inserter device.
[0004] Cost-effective manufacture of infusion tube systems for
infusion devices requires low or reduced material costs and low or
no scrap rate in the production process. Further, it may be
desirable to reduce or remove one or more processes in the
manufacture cycle.
SUMMARY
[0005] Thus there is a need for devices and methods for reducing
material waste in production or manufacture of infusion tube
systems. Further, there may be a need for infusion tube systems
enabling use of simple infusion devices, e.g. infusion devices with
simple coupling systems.
[0006] Accordingly, an infusion tube system is provided, the
infusion tube system comprising an infusion tube and a connector
attached to the infusion tube at an end of the infusion tube, the
connector having a proximal end and comprising a connector body
extending from a distal end to a proximal end along a center axis
and defining a cavity, the connector body comprising an end wall
with an inner surface, and at least one vent opening including a
first vent opening, and a sidewall extending from the end wall
along the center axis with an inner and outer surface. The
connector comprises a membrane covering the at least one vent
opening, the membrane being welded to the inner surface of the end
wall along at least one welding seam including a first welding seam
such that the membrane covers and seals the at least one vent
opening.
[0007] It is an important advantage of the present invention that
membrane material covering the vent openings has not been subject
to substantial heat caused by the welding process, thereby ensuring
that the membrane material function as intended leading to more
effective manufacture of infusion tube systems due to reduced
material waste. Further, the present invention enables a more
effective manufacture of tube infusion system due to smaller number
of defective tube infusions system and a reduced scrap rate.
[0008] Further disclosed is a method for manufacture of an infusion
tube system comprising an infusion tube and a connector, the method
comprising providing a connector with a connector body extending
from a distal end to a proximal end along a center axis and
defining a cavity, the connector body comprising an end wall with
an inner surface, and at least one vent opening including a first
vent opening, and a sidewall extending from the end wall along the
center axis with an inner and outer surface. The method further
comprises providing a membrane at the inner surface of the end
wall, and welding the membrane to the inner surface of the end wall
along at least one welding seam including a first welding seam such
that the membrane covers and seals the at least one vent
opening.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] The above and other features and advantages of the present
invention will become readily apparent to those skilled in the art
by the following detailed description of exemplary embodiments
thereof with reference to the attached drawings, in which:
[0010] FIG. 1 is a first perspective view of an exemplary infusion
tube system;
[0011] FIG. 2 is a second perspective view of the infusion tube
system in FIG. 1;
[0012] FIG. 3 is an end view of the infusion tube system in FIG. 1
seen from the distal end of the connector perpendicular to the
center axis;
[0013] FIG. 4 is a cross section U-U of the infusion tube system in
FIG. 1 as indicated in FIG. 5;
[0014] FIG. 5 shows an infusion tube system perpendicular to the
center axis;
[0015] FIG. 6 is a detailed view of a part of the infusion tube
system as indicated by the circle in FIG. 4;
[0016] FIG. 7 is a side view of infusion tube systems;
[0017] FIG. 8 is a cross section A-A of infusion tube systems as
indicated in FIG. 7;
[0018] FIG. 9 is a first perspective view of an exemplary infusion
tube system;
[0019] FIG. 10 is a second perspective view of the infusion tube
system in FIG. 9;
[0020] FIG. 11 is an end view of the infusion tube system in Fig, 9
seen from the distal end of the connector perpendicular to the
center axis;
[0021] FIG. 12 is a side view of the infusion tube system of FIG.
9;
[0022] FIG. 13 is a cross section O-O of the infusion tube system
of FIG. 9 as indicated in FIG. 12;
[0023] FIG. 14 is a detailed view of a part of the infusion tube
system as indicated by the circle in FIG. 13;
[0024] FIG. 15 is a perspective view of an exemplary weld horn used
for manufacture of the infusion tube system of FIG. 1-6;
[0025] FIG. 16 schematically illustrates steps of the method
according to the present invention; and
[0026] FIG. 17 is a cross section U-U of an exemplary infusion tube
system as indicated in FIG. 5.
DETAILED DESCRIPTION
[0027] The figures are schematic and simplified for clarity, and
they merely show details which are essential to the understanding
of the invention, while other details have been left out.
Throughout, the same reference numerals are used for identical or
corresponding parts.
[0028] The infusion tube system comprises an infusion tube and a
connector at an end, e.g. a first end, of the infusion tube. The
connector may be adapted for coupling to an net or outlet port of
an infusion device having a housing accommodating a pump device and
a reservoir with medicine, e.g. insulin, or other infusion
liquid.
[0029] The connector has a distal end, a proximal end and a
connector body extending from a distal end to a proximal end of the
connector body along a center axis and defining a cavity.
[0030] The connector body comprises an end wall with an inner
surface, and at least one sidewall extending from the end wall
along the center axis and having an inner and outer surface. The
inner surface of the end wall and the sidewall define or at least
partly define the cavity. The cavity may be cylindrical or at least
partly cylindrical with a cross section of suitable size and shape,
i.e. the inner surface of the sidewall may have a cross section
perpendicular to the center axis, the cross section being
substantially constant along at least a part of the center axis. In
one or more embodiments, cross section areas of the cavity may
increase towards the distal end of the connector. The cavity may be
cylindrical with a circular or non-circular (oval, polygonal or
elliptical) inner surface cross-section perpendicular to the center
axis.
[0031] The end wall comprises at least one vent opening including a
first vent opening. The at least one vent opening connects or
communicates the cavity with the surroundings through the end wall
and a membrane covering the at least one vent opening. The at least
one vent opening may include a plurality of vent openings including
the first vent opening and a second vent opening formed in the end
wall. Further, a third and/or fourth vent opening may be formed in
the end wall. A vent opening may have any suitable size and shape.
In one or more embodiments, one or more vent openings are circular,
elliptical, kidney-shaped or oval, e.g. with a diameter or maximum
extension less than 8 mm, such as in the range from 0.5 mm to 5 mm.
In one or more embodiments, one or more vent openings may have an
area in the range from 0.3 mm.sup.2 to 20 mm.sup.2. The area of the
respective vent openings depends e.g. on the number of vent
openings in the end wall and the available inner surface area of
the end wall. In one or more embodiments with three to six vent
openings, the area of each vent opening may be in the range from
0.3 mm.sup.2 to 2 mm.sup.2. In one or more embodiments, with one or
two vent openings, the area of the vent openings may be in the
range from 1.0 mm.sup.2 to 10 mm.sup.2.
[0032] The connector comprises a membrane covering the at least one
vent opening including the first vent opening and other vent
openings if present. The membrane is welded to an inner surface
defining the cavity. The membrane may be welded to the inner
surface of the end wall such that the membrane covers and seals the
at least one vent opening including the first vent opening and
other vent openings if present. Thus air or other gasses must pass
the membrane in order to flow from the cavity to the surroundings
through the at least one vent opening, e.g. in order to equalize
pressure between the cavity and the surroundings. The membrane
enables pressure equalization of a cavity within an infusion device
through the vent opening and at the same time providing a
substantially liquid tight infusion device when the infusion tube
system is connected to the infusion port of the infusion
device.
[0033] The membrane is welded to the inner surface of the end wall
along at least one welding seam including a first welding seam and
optionally a second welding seam. The first welding seam and/or the
second welding seam may form a dosed curve. The first welding seam
may surround at least the first vent opening. In one or more
embodiments, the first welding seam surrounds all the vent openings
in the end wall. In one or more embodiments, the second welding
seam may if present form a closed curve surrounding a fluid path
opening or a connector needle in the end wall.
[0034] The second welding seam may form a dosed curve surrounding
one or more vent openings including a second vent opening in the
end wall.
[0035] The first welding seam may form a dosed outer welding seam
and the second welding seam may form a dosed inner welding seam
surrounded by the outer welding seam, wherein the membrane area
between the inner welding seam and the outer welding seam covers at
least one vent opening, e.g. the first vent opening. In one or more
embodiments, the membrane area between an inner welding seam and an
outer walling seam covers all vent openings in the end wall.
Welding seams may cross each other.
[0036] In one or more embodiments welding seam(s), e.g. the first
welding seam and/or a second welding seam, forms a dosed curve
surrounding one or more vent openings and wherein the connector
needle or a fluid path opening in the end wall is arranged outside
the dosed curve of the welding seam.
[0037] A welding seam may have a suitable length which at least for
an outer welding seam may depend on the number and configuration of
vent openings to be surrounded. In one or more embodiments, the
first welding seam may have a length in the range from 4 mm to
about 100 mm, such as in the range from 10 mm to 50 mm, such as
about 30 mm. The welding seam must be sufficiently wide to ensure
sealing of the membrane to the inner surface of the cavity. On the
other hand, the width of a \welding seam is limited, e.g. in order
to maximize the non-welded area of the membrane. Accordingly, a
welding seam, e.g. the first welding seam and/or the second welding
seam may have a width in the range from 0.1 mm to 3.0 mm, such as
from 0.3 mm to 2.0 mm. In one or more embodiments, a welding seam
width of 0.5 mm to 1 mm may be advantageous.
[0038] The total welding area being the sum of welding areas for
respective welding seams may be less than 95% of the common area
between the membrane and the inner surface of the end wall. In one
or more embodiments, the total welding area is less than 90% of the
common, i.e. overlapping, area between the membrane and the inner
surface of the end wall.
[0039] The total welding area being the sum of welding areas for
respective welding seams may be less than 90% of the area of the
inner surface of the end wall. In one or more embodiments, the
total welding area being the sum of welding areas for respective
welding seams may be less than 70%, such as less than 50% of the
area of the inner surface of the end wall.
[0040] The membrane is made of a suitable material in order to
allow air or other gasses to flow through the membrane while
substantially preventing liquid, e.g. water from the surroundings,
to pass the membrane. The membrane may be air-permeable and may be
made of or comprise a thermoplastic polymer, such as
Polytetrafluoroethylene (PTFE). The membrane may be a hydrophobic
membrane.
[0041] The membrane may be attached to the inner surface of the
cavity by various welding methods, preferably by ultrasonic
welding.
[0042] The connector may comprise a hollow connector needle with a
distal end attached to the connector body and extending from the
inner surface of the end wall into the cavity forming a fluid path
between the infusion tube and the cavity. A fluid path opening may
be formed in the inner surface of the end wall forming a fluid path
between the infusion tube and the cavity.
[0043] The connector may comprise at least one annular protrusion
including a first annular protrusion on the inner surface of the
end wall, the first annular protrusion surrounding at least the
first opening, wherein the membrane is welded to the inner surface
of the end wall along the first annular protrusion.
[0044] The connector may comprise a support structure extending
from the end wall in a proximal direction along the center axis.
The support structure may define a support cavity accommodating at
least a part of the infusion tube. Typically, a part of the outer
surface of the infusion tube is attached to an inner surface of the
support structure defining the support cavity.
[0045] FIG. 1-6 show different views of an infusion tube system
according to the present invention. The infusion tube system 1
comprises an infusion tube 2 and a connector 4 attached to the
infusion tube at an end of the infusion tube. The connector 4
having a proximal end 6 and comprising a connector body 8 extending
from a distal end 10 to a proximal end 12 along a center axis X and
defining a cavity 14. The connector body 8 comprises an end wall 16
with an inner surface 18 and an outer surface 20. At least one vent
opening including a first vent opening 22 is formed in the end wall
16. The connector 4 illustrated in FIGS. 1 and 2 has a second vent
opening 24, and optionally a third vent opening 26 and/or a fourth
vent opening 28 in the end wail 16. The connector body 4 comprises
a sidewall 30 extending from the end wall along the center axis
with an inner surface 32 and an outer surface 34. Further, the
connector 4 comprises a membrane 36 covering the vent openings 22,
24, 26, 28. The membrane 36 is welded to the inner surface 18 of
the end wall along a first welding seam 38 and a second welding
seam 40 such that the membrane 36 covers and seals the four vent
openings 22, 24, 26, 28. The vent openings 22, 24, 26, 28 have a
circular cross-section perpendicular to the center axis with a
diameter D.sub.1, D.sub.2, D.sub.3, D.sub.4, respectfully, of about
1 mm. The cavity 14 defined by the inner surfaces 18, 32 is
cylindrical with a circular cross-section having a diameter of
about 12 mm and a length of about 10 mm. The connector optionally
comprises a hollow connector needle 42 attached to the connector
body and extending from the inner surface of the end wall into the
cavity. The connector needle 42 forms a fluid path from the flow
channel in the infusion tube 2 to the distal end 44 of the hollow
connector needle 42. In the absence of a connector needle, a fluid
path opening in the end wall may connect the flow channel of the
infusion tube with the cavity.
[0046] The first welding seam 38 forms a closed curve in the form
of a circle having a diameter in the range from 8 to 10 mm
surrounding the first, second, third and fourth vent opening, and
the second welding seam 40 forming a closed curve, e.g. a circle
with a diameter e.g. of about 3.5 mm to 4.5 mm, surrounding the
connector needle 42 and positioned on the inside of the vent
openings as seen e.g. in the end view in FIG. 3 and in the detailed
view in FIG. 6. The first welding seam 38 forms a closed outer
welding seam and the second welding seam 40 forms a closed inner
welding seam surrounded by the outer welding seam 38, wherein the
membrane area 46 between the inner welding seam and the outer
welding seam covers the vent openings in the end wall, i.e. the
four vent openings 22, 24, 26, 28 in this configuration. The first
and second welding seams each have a width about 1 mm.
[0047] The membrane 36 is circular with a diameter about the
diameter of the inner surface of the end wall (e.g. .+-.15%). An
opening may be formed in the membrane to allow the connector needle
to pass therethrough.
[0048] The connector 4 comprises a support structure 48 extending
from the end wall 16 in a proximal direction along the center axis.
The support structure 48 defines a cavity accommodating at least a
part of the infusion tube, the infusion tube being attached to the
inner surface defining the cavity, e.g. by gluing. The outer
surface of the support structure 48 is adapted for facilitating
manual handling of the infusion tube system, e.g. when the
connector is to be connected to a device, such as an infusion port
of an infusion device.
[0049] FIGS. 7 and 8 is a sideview of infusion tube systems 1, 100
and a cross-section A-A as indicated. The infusion tube systems 1,
100 are shown without membrane 36. A sealing element 50 is formed
as an annular protrusion on the outer surface 34 and perpendicular
to the center axis X. The sealing element 50 may be formed as an
integrated part of and in the same material as the connector body
8. In one or more embodiments, the sealing element may be molded to
the connector body in a two-step molding process, e.g. in a
resilient material to facilitate coupling and sealing of the
connector hi an infusion port. In one or more embodiments, the
sealing element may be an o-ring at least partly accommodated in an
annular recess hi the outer surface 34 of the sidewall 30.
[0050] FIGS. 9-14 show different views of an infusion tube system
according to the present invention. The infusion tube system 100
only has a first vent opening 22 in the end wall 16. A first
welding seam 38 forms a closed oval curve surrounding the first
vent opening 22, thereby sealing the first vent opening with the
membrane 36. The connector needle 42 is arranged outside the closed
curve of the first welding seam 38.
[0051] The first vent opening 22 in the infusion tube system 100 is
oval and having an area of about 1.5 mm.sup.2 (W=1 mm and length
L=2 mm) A single or limited number of vent openings may allow for a
smaller membrane leading to material cost savings. The membrane 36
of infusion tube system 100 is about half the size of the membrane
area in infusion tube system 1 as shown in FIG. 1-6.
[0052] FIG. 15 shows a weld horn used for manufacture of the
infusion tube system 1. The weld horn 300 comprises a body 301 with
a first annular protrusion 302 and second annular protrusion 304
for forming the first welding seam 38 and the second welding seam
40, respectively of infusion tube system 1.
[0053] FIG. 16 is a flow chart illustrating a method according to
the invention namely a method for manufacture of an infusion tube
system comprising an infusion tube and a connector. The method 400
comprises providing 402 a connector with a connector body extending
from a distal end to a proximal end along a center axis and
defining a cavity, the connector body comprising an end wall with
an inner surface, and at least one vent opening including a first
vent opening, and a sidewall extending from the end wall along the
center axis with an inner and outer surface. Further, the method
comprises providing 404 a membrane 36 at the inner surface of the
end wall, and welding 406 by ultrasonic welding a membrane to the
inner surface of the end wall along at least one welding seam
including a first welding seam 38 such that the membrane covers and
seals the at least one vent opening. Welding 406 comprises pressing
the membrane between the connector body 8 and a weld horn 300
comprising at least one annular weld protrusion forming at least
one welding seam.
[0054] FIG. 17 shows a cross-section of an exemplary infusion tube
system 102. For illustrative purposes, the membrane is not shown in
FIG. 17. The connector 4 comprises at least one protrusion
extending from the inner surface 18 of the end wall in the distal
direction, i.e. towards the distal end 10. The at least one
protrusion comprises a first protrusion 52 forming a circular or
annular protrusion, e.g. surrounding the vent openings 22, 24, 26,
28. Further, a second protrusion 54 forms a circular or annular
protrusion by the first protrusion, wherein the vent openings 22,
24, 26, 28 are positioned between the first protrusion 52 and the
second protrusion 54 radially from the center axis. The protrusions
52, 54 may have a height, of at least 0.5 mm. In an embodiment
similar to the infusion tube system 100, a first protrusion forming
a dosed curve may surround one or more vent openings while the
connector needle or a fluid path opening is positioned on the
outside of the dosed curve formed by the first protrusion.
[0055] The support structure 48 and the connector body 8 may form
an integrated unit, i.e. molded in a single process as illustrated
in the figures.
[0056] It should be noted that in addition to the exemplary
embodiments of the invention shown in the accompanying drawings,
the invention may be embodied in different forms and should not be
construed as limited to the embodiments set forth herein. Rather,
these embodiments are provided so that this disclosure will be
thorough and complete, and will fully convey the concept of the
invention to those skilled in the art.
LIST OF REFERENCES
[0057] 1, 100, 102 infusion tube system [0058] 2 infusion tube
[0059] 4 connector [0060] 6 proximal end of connector [0061] 8
connector body [0062] 10 distal end of connector body [0063] 12
proximal end of connector body [0064] 14 cavity [0065] 16 end wall
[0066] 18 inner surface of end wail [0067] 20 outer surface of end
wall [0068] 22 first vent opening [0069] 24 second vent opening
[0070] 26 third vent opening [0071] 28 fourth vent opening [0072]
30 sidewall [0073] 32 inner surface of side wall [0074] 34 outer
surface of side wall [0075] 36 membrane [0076] 38 first welding
seam [0077] 40 second welding seam [0078] 42 connector needle
[0079] 44 distal end of connector needle [0080] 46 sealing membrane
area [0081] 48 support structure [0082] 50 sealing element [0083]
52 first protrusion [0084] 54 second protrusion [0085] 200 detail
view [0086] 300 weld horn [0087] 301 body [0088] 302 first annular
protrusion [0089] 304 second annular protrusion [0090] X center
axis X
* * * * *