U.S. patent application number 11/810427 was filed with the patent office on 2008-12-11 for fluid flow connector permitting forceful lateral separation.
Invention is credited to William J. Schnell, David S. Utterberg.
Application Number | 20080303267 11/810427 |
Document ID | / |
Family ID | 40094069 |
Filed Date | 2008-12-11 |
United States Patent
Application |
20080303267 |
Kind Code |
A1 |
Schnell; William J. ; et
al. |
December 11, 2008 |
Fluid flow connector permitting forceful lateral separation
Abstract
A fluid flow connector comprises a connector body which carries
a first connector tube having a lumen for receiving a second
connector tube when the connectors are joined. The first connector
tube has a lumen and a lumen wall. The first connector tube
typically has an end portion that carries a plurality of
circumferentially spaced, outerwardly extending lugs to engage the
second connector tube when connected. The fluid flow connector is
made of a plastic having a flexural modulus that is low enough to
allow deformation, permitting a connected, engaging second
connector to pop loose from connection with the fluid flow
connector when laterally struck, rather than breaking the fluid
flow connector. Also, the first, fluid flow connector may
optionally be frictionally retained in a retracted position where
fluid flow is blocked through the connectors by a skirt of the
second connector, which skirt has an inner diameter in frictional
engagement with radially outer surfaces of the lugs of the first
connector, for frictional retention of the connectors.
Inventors: |
Schnell; William J.;
(Libertyville, IL) ; Utterberg; David S.;
(Seattle, WA) |
Correspondence
Address: |
SEYFARTH SHAW LLP
Suite 2400, 131 South Dearborn Street
Chicago
IL
60603-5577
US
|
Family ID: |
40094069 |
Appl. No.: |
11/810427 |
Filed: |
June 5, 2007 |
Current U.S.
Class: |
285/26 |
Current CPC
Class: |
A61M 2039/1077 20130101;
A61M 2205/0216 20130101; A61M 39/10 20130101; A61M 2039/1072
20130101 |
Class at
Publication: |
285/26 |
International
Class: |
B61G 5/08 20060101
B61G005/08 |
Claims
1. A fluid flow connector, which comprises: a connector body which
carries a first connector tube having a lumen for receiving a
second connector tube of a second connector when said connectors
are joined; said first connector tube having a lumen and a lumen
wall; said first connector tube carries a plurality of
circumferentially spaced, outwardly extending lugs to engage the
second connector when connected; the first connector tube being
made of a plastic having dimensions and a flexural modulus that is
low enough to allow deformation, permitting a connected, engaging
second connector to pop loose from connection with the fluid flow
connector when laterally struck, rather than breaking the fluid
flow connector.
2. The fluid flow connector of claim 1, connected to said second
connector, with said connector tubes being together in telescoping
relation but essentially radially spaced from each other to avoid
substantial frictional retention between said connector tubes.
3. The fluid flow connector of claim 2 in which only a pair of said
lugs are present, said lugs being substantially diametrically
opposed to each other.
4. The fluid flow connector of claim 3 in which second connector
threads are carried by a second connector skirt that surrounds the
lugs of the first connector when connected, said skirt having an
inner diameter that is in frictional engagement with radially outer
surfaces of said lugs of the first connector, for frictional
retention of said connectors.
5. The fluid flow connector of claim 4 in which the first and
second connectors are frictionally retained in a retracted position
in which fluid flow is blocked through the connectors by a
perforated diaphragm carried within the first connector and spaced
from the second connector tube.
6. The fluid flow connector of claim 1 in which said deformation
comprises the momentary deformation of at least a portion of said
first connector tube from cylindrical to substantially oval
cross-section.
7. The fluid flow connector of claim 1 in which said plastic has a
flexural modulus of no more than essentially 370,000 psi.
8. The fluid flow connector of claim 1 in which said first
connector tube has an inner diameter of at least 5.5 mm along its
entire length.
9. The fluid flow connector of claim 1, carried on a substantially
rigid, pressure sensing chamber for an extracorporeal blood
line.
10. The fluid flow connector of claim 9 in which said pressure
sensing chamber and said fluid flow connector comprise an
integrally molded, single piece.
11. The fluid flow connector of claim 3 in which said plastic has a
flexural modulus of no more than essentially 370,000 psi.
12. The fluid flow connector of claim 11 in which said first
connector tube has an inner diameter of at least 5.5 mm along its
entire length.
13. The fluid flow connector of claim 1 in which said first
connector tube has a length of 3.5 to 6 mm.
14. The fluid flow connector of claim 1 in which said first
connector tube has a wall thickness of 0.6 to 1.1 mm.
15. The fluid flow connector of claim 1 in which the first
connector tube has a conical lumen wall having an angle of greater
than three degrees to the lumen axis.
16. A medical connector which comprises: a connector body which
carries a first connector tube having a lumen for receiving a
second connector tube of a second connector when the connectors are
joined; said medical connector having a perforated diaphragm
carried by the connector body and controlling flow through the
first connector tube; a locking member provided for locking
connection with a second connector having a second connector tube
that enters into the lumen; said first connector tube being made of
a material and dimensions to permit deformation thereof when the
first connector tube is forcefully and laterally struck, causing
disconnection of the first and second connector tubes rather than
breakage of the connector body or first connector tube.
17. A fluid flow connector which comprises: a connector body which
carries a first connector tube having a lumen receiving a second
connector tube of a second connector when the connectors are
joined; said first connector tube having a lumen of an inner
diameter that is greater than the greatest outer diameter of the
second connector tube; and a lumen wall of angled cone shape
defining an angle, at least in a major outer portion thereof, to
the longitudinal axis of the first connector, that is from 5 to
100; said first connector tube being made of a plastic having a
dimensions and flexural modulus that is low enough to allow
deformation permitting said connected, engaging second connector
tube to pop loose from connection with the fluid flow connector
when laterally struck, rather than breaking the fluid flow
connector.
18. The fluid flow connector of claim 17 in which said first
connector tube has an end portion that carries a plurality of
circumferentially spaced, outwardly extending lugs engaging
inwardly extending threads or lugs of the second connector when
connected, said lugs of the first connector tube being
substantially diametrically opposed to each other.
19. The fluid flow connector of claim 17 said second connector
defining at least a pair of connector arms having free ends with
retention hooks, proportioned to snap-engage said connector body
for retention of the connectors together.
20. The fluid flow connector of claim 18 in which said plastic of
the first connector tube has a flexural modulus of no more than
essentially 370,000 psi.
21. The fluid flow connector of claim 20 in which a perforated
diaphragm is carried within said first connector to be opened by
said second connector tube.
22. A fluid flow connector, which comprises: a connector body which
carries a first connector tube having a lumen for receiving a
second connector tube of a second connector when the connectors are
joined; a perforated diaphragm carried within said first connector;
said second connector carrying a skirt that surrounds the lugs of
the first connector, said skirt having an inner diameter that is in
frictional engagement with radially outer surfaces of said lugs of
the first connector, said first and second connectors being
positioned by said frictional engagement with the second connector
tube within the first connector tube, with the second connector in
a retracted position with the second connector tube being spaced
from the perforated diaphragm, and in which fluid flow is blocked
through the connectors by said perforated diaphragm, said second
connector being capable of being advanced farther into said first,
fluid flow connector to cause the perforated diaphragm to open said
perforation, to permit fluid flow through said joined connectors.
Description
BACKGROUND OF THE INVENTION
[0001] Extracorporeal blood sets are used for conveying blood from
a patient to an extracorporeal blood treatment device, such as a
dialyzer. These blood sets conventionally contain various
components for obtaining access to an intermediate portion of the
blood set, such as an injection site access port, a Y connector
access port, or the like. Also, an access port may be carried on a
flow-through chamber positioned in the set between the ends
thereof. Such a chamber may be a pressure chamber having rigid
walls for pressure measurement, and may carry a fluid flow
connector access site, for example a needleless access site of a
known type, such as a needleless access site of the type disclosed
in U.S. Pat. No. 7,025,744.
[0002] This access site may be connected with a syringe, or a tube
set having a luer or luer lock connector, for the administration of
parenteral solution or other medicament, or for venting air, or for
administration of blood, or the like.
[0003] During use, for example in a hemodialysis procedure, a
needleless access site or the like may be carried on a rigid
chamber in the dialysis set. A syringe containing heparin or the
like may be carried during the procedure in the needleless access
site. If the syringe is somehow accidentally, laterally struck, a
great deal of torque is exerted on the needleless access site, with
the syringe acting as a lever arm. Conventional needle access sites
may break off in such a circumstance, if the rigid chamber that
carries them is firmly held in an immovable position. This, of
course, is a serious problem, requiring immediate action and
causing great inconvenience and possibly loss of blood.
[0004] By this invention, a fluid flow connector, which may be a
needleless access site, is provided in which a sharp, lateral blow
to a second connector or the like which is laterally connected to
the fluid flow connector is not likely to cause breakage. Rather,
the fluid flow connector is designed so that the second connector
will pop out of connection with the fluid flow connector when it is
struck with a severe, lateral blow, which might otherwise cause
breakage. This may be of much less serious consequence, and is more
easily corrected than the situation where the fluid flow connector
is actually broken, which generally requires termination of the
extracorporeal blood flow procedure, replacement of the set, breach
of sterility, and repriming.
[0005] Furthermore, by this invention, the fluid flow connector
which is provided can be of a proportion allowing swabbing with an
antiseptic such as isopropyl alcohol prior to use, particularly
when comprising a tubular access site and connector which contains
an internal, perforated sealing diaphragm which may be opened by a
male luer or other tubular connector member. This may be
accomplished in part by typically enlarging the inner diameter of
the fluid flow connector, above and beyond typical connectors that
conform to ANSI specifications.
DESCRIPTION OF THE INVENTION
[0006] By this invention, a first fluid flow connector comprises: a
connector body which carries a first connector tube having a lumen
for receiving a second connector tube of a second connector when
said connectors are joined. The first connector tube may have a
lumen and a lumen wall, for example of angled cone shape, in at
least a major outer portion thereof, to the longitudinal axis of
the first connector. The first connector tube carries a plurality
of circumferentially spaced, outwardly extending lugs, to engage
inwardly extending threads or lugs of the second connector tube
when connected.
[0007] The first fluid flow connector may be made of a plastic
which has a dimensions (especially thickness) and a flexural
modulus that is low enough to allow deformation, permitting a
connected, engaging second connector to pop loose from connection
with the fluid flow connector when laterally struck, rather than
breaking the first fluid flow connector.
[0008] The lugs of the first connector tube may comprise
interrupted screw threads that occupy a spiral section, or they may
comprise lugs that occupy essentially a single, longitudinal
position along the length of the first connector tube. Typically,
the lugs in question are diametrically opposed and extend in an arc
about the connector tube ranging from essentially 40 to about
180.degree.. In some embodiments, only a pair of said lugs are
present, the lugs being substantially diametrically opposed to each
other.
[0009] In some embodiments, the first fluid flow connector
described above may be connected to the second connector, with the
connector tubes being together in telescoping relation but radially
spaced from each other at least at an outer portion of the lumen
wall, or essentially completely radially spaced from each other, to
avoid substantial frictional retention between the connector tubes.
Thus, without added retention, the connectors would tend to fall
apart, a 360 degree gap between the connector tubes being present,
in some embodiments, on the order of at least 0.1 mm.
[0010] Typically the conical lumen wall shape is at an angle of
greater than three degrees to the lumen axis, thus providing
lateral movability or rotatability to the engaging first and second
connector tubes.
[0011] Alternatively, the second connector tube may define an outer
wall of lesser angle to the longitudinal axis of the first
connector than the angle of the first lumen wall major outer
portion described above. In this embodiment, a zone of contact
between the first connector tube and the second connector tube may
be present as a relatively short zone along the length of the
respective tubes, and remaining portions of the tubes are laterally
(radially) spaced.
[0012] The above embodiments allow a measure of lateral movement
between the first and second connector tubes, to facilitate the
popping loose of the second connector if forcefully and laterally
struck.
[0013] When the fluid flow connector carries an elastomeric, slit
diaphragm, in a manner similar to that disclosed in U.S. Pat. No.
7,025,744, (the disclosures of which are incorporated by reference
herein), the second connector tube can effectively open the
diaphragm by opening the perforation, to open flow through the
connected system. Then, when the second connector tube is withdrawn
again out of engagement with the perforated diaphragm, the
elastomeric diaphragm reseals again to block fluid flow.
[0014] In another embodiment, the second connector tube can be
completely, laterally spaced from the inner wall that defines the
lumen, while positioned in the lumen so that the second connector
tube is typically only in contact with the fluid flow connector by
its engagement with the diaphragm, when in connected, flow
permitting position.
[0015] Further by this invention, the second connector threads or
lugs may be carried by a skirt that surrounds the lugs of the first
connector. The skirt has an inner diameter less than the maximum
diameter of the diametrically opposed lugs, to be in frictional
engagement with radially outer surfaces of the lugs of the first
connector, for frictional retention of said connectors together. In
this circumstance, it can be possible for the fluid flow connector
and the second connector to be frictionally retained in a retracted
position, in which the second connector tube is spaced from the
perforated diaphragm, so that fluid flow is blocked through the
connectors by the perforated diaphragm, but the two connectors are
held together in a retained condition.
[0016] Thus, a syringe which carries a second connector may be
brought into connection with the first fluid flow connector, and
advanced so that the second connector tube of the second connector
penetrates and opens the diaphragm, or the second connector can be
in a retracted position, but is still frictionally retained with
the first fluid flow connector, with the second connector tube
being spaced from the diaphragm, so that the diaphragm is closed,
and flow through the system is prevented.
[0017] Thus, the syringe may be held on an extracorporeal blood
flow set by an attached fluid flow connector during a procedure,
with flow being closed between the syringe and the set. Then, as
desired, the syringe can be advanced, and flow is opened for
administration of medicament or the like, or the taking of a blood
sample. Then the syringe may retract again, while remaining in
retained condition.
[0018] As stated above, the first fluid flow connector may be made
of plastic having a flexural modulus that is low enough to allow
deformation permitting a connected, engaging second connector to
pop loose from connection with the fluid flow connector when
laterally struck. In some embodiments, this flexural modulus may be
no more than about 370,000 psi, for example from about 250,000 to
350,000 psi, as determined by ASTM D 790. As stated, this popping
away, rather than breaking of the fluid flow connector, is
facilitated by the low flexural modulus as indicated for the
plastic, as well as by a space defined between the first and second
connector tubes permitting some lateral motion, with or without
pivoting, between the first and second connector tubes when
laterally struck. Also, momentary deformation of at least a portion
of the first connector tube from cylindrical to a substantially
oval cross section may take place upon the lateral striking, to
facilitate spontaneous disconnection rather than breakage.
[0019] In some embodiments, the first connector tube may have an
inner diameter of at least 5.5 mm along its entire length, less
than a conventional ANSI connector. This inner diameter may vary,
since, typically, the first connector tube defines at least a
portion of lumen wall of angled cone shape.
[0020] In some embodiments, the first connector tube may have a
length of 3.5-6 mm, which is less than a conventional ANSI
connector, and which facilitates spontaneous disconnection upon
lateral striking.
[0021] In some embodiments, the wall thickness of the first
connector tube may be from essentially 0.6 to 1.1 mm, which is
typically less than conventional-ANSI tubular connection sites, to
further facilitate the above-described, spontaneous disconnection
on lateral striking.
[0022] In some embodiments, the fluid flow connector of this
invention may be carried on a generally rigid pressure sensing
chamber, and the connector and chamber may comprise an integrally
molded, single piece. If desired, a portion of the chamber may be
comolded with the fluid flow connector of this invention and then
attached to another chamber component. Thus, the fluid flow
connector may be carried on the substantially rigid pressure
sensing chamber.
[0023] Thus there is provided a medical connector which comprises:
a connector body which carries a first connector tube having a
lumen for receiving a second connector tube of a second connector
when the connectors are joined; the medical connector having a
perforated diaphragm carried by the connector body and sealingly
occluding flow through the first connector tube. A locking member
is provided for locking connection with a second connector having a
second connector tube that enters into the lumen. The first
connector tube may be made of a material and dimensions to permit
deformation thereof when the first connector tube is forcefully and
laterally struck, causing disconnection of the first and second
connector tubes rather than breakage of the connector body or first
connector tube.
DESCRIPTION OF THE DRAWINGS
[0024] In the drawings, FIG. 1 is an elevational view of two
connectors, prior to connection with each other, in accordance with
this invention.
[0025] FIG. 2 is a sectional view taken along line 2-2 of FIG.
1.
[0026] FIG. 3 is an enlarged, longitudinal sectional view of a
portion of the female connector of FIGS. 1-2 that defines a conical
lumen.
[0027] FIG. 4 is a perspective view of the component of FIG. 3.
[0028] FIG. 5 is a plan view of the component of FIG. 3, showing a
section of the second connector skirt in connected relation.
[0029] FIG. 6 is an elevational view of the component of FIG.
3.
[0030] FIG. 7 is a longitudinal sectional view of the component of
FIG. 3.
[0031] FIG. 8 is an elevational view of the respective connectors
of FIGS. 1-2, shown in connected form.
[0032] FIG. 9 is a sectional view taken along line 9-9 of FIG.
8.
[0033] FIG. 10 is an enlarged view of a portion of FIG. 9, showing
a fully forward, different, connected position.
[0034] FIG. 11 is a longitudinal, sectional view showing the
connected system of FIG. 10, in which the male connector has been
laterally struck and is in the process of popping out of connection
from the female connector.
DESCRIPTION OF SPECIFIC EMBODIMENTS
[0035] Referring to the drawings, FIGS. 1-11 disclose a first
embodiment of a fluid flow connector 10, which is shown to be a
female connector, having a connector body comprising a forward
component 12 and a rearward component 14. Between the two connector
components there is a peripherally secured, elastomeric diaphragm
16, which defines a perforation 18, such as a slit which provides
sealing against fluid flow at a substantially predetermined range
of pressures. Sleeve 17 of forward component 12 sealingly engages
annular enlargement 19 of rearward component 14 by a conventional
sealing process.
[0036] Connector body component 12 carries a first connector tube
20, which has a lumen 21, defined by conical wall 22, wall 22 being
of cone shape that, in some embodiments, defines an angle to the
longitudinal axis 24 of connector 10 that is greater than about 3
degrees, such as 5.degree. to 10.degree..
[0037] First connector tube 20 has an end portion that carries a
plurality of circumferentially spaced, outwardly extending lugs 26,
for engaging inwardly extending threads 28 (or lugs) of a skirt 30
of a second connector 32. Second connector 32 may comprise a
conventional syringe 33 having a conventional male luer lock
connector on its end. The male luer second connector tube 34 of
second connector 32 may have a conventional taper that is less than
the taper of conical wall 22, with respect to axis 24. Thus, when
the two connectors 10, 32 are connected, as shown in FIG. 10, the
lesser angle of the male luer second connector tube 34, compared
with the lumen angle of conical wall 22, causes the respective
connector tubes 20, 34 to be spaced from each other, as at space 36
(FIG. 10) at least at an outer portion of first connector tube 20,
or tubes 20, 34 are entirely radially spaced, optionally. The
respective connector tubes 20, 32 may be frictionally joined
together at an inner junction area 36, if desired.
[0038] Also, it can be seen from FIG. 10 that when the connectors
10, 32 are joined together, in the fully advanced position of
threaded skirt 30 and lugs 26, perforation 18 of diaphragm 16 is
stretched by male luer 34 to be greatly enlarged, to connect with
aperture 18a that can be large enough to permit laminar flow from
male luer second connector 34 into and through lumen 38 of
connector 10.
[0039] Threads or lugs 26 of first fluid flow connector 10 are
helically arranged like an interrupted screw thread, and are
substantially diametrically opposed to each other. It can also be
seen from FIG. 5 that the radially outer edge 39 of lugs or threads
26 defines an arc, so that ends 40 of arc 39 (FIG. 5) merge with
the outer surface of first connector tube 20, while central
portions of lug outer surface 38 are radially outwardly spaced from
the outer surface of first connector tube 20. This shape
facilitates the "pop-off" characteristic of the respective
connectors 10, 32.
[0040] Second connector threads 28 are carried by skirt 30 that
surrounds lugs 26 of first connector tube 20. In this embodiment,
skirt 30 has an inner surface 43 between threads 28 that is in
frictional engagement with radially outer surfaces of lugs 26, so
that the position of the respective connectors 10, 32 may be
maintained by frictional retention between lugs 26 and inner
surface 43 of skirt 30, as in FIGS. 5 and 9. The radially outermost
outer surface 42 of lugs 26 are slightly radially larger in
diameter than the inner diameter 43 of skirt 30, typically by about
0.1 to 0.7 mm. to make this happen .
[0041] Thus, if the connectors 10, 32 are relatively withdrawn so
that second connector tube 34 is no longer in contact with
diaphragm 16, which diaphragm closes again to its original sealing
position of FIG. 2, the two connectors may still be retained
together by the frictional retention between lugs 26 and the inner
surface 43 of skirt 30, as shown particularly in FIG. 9. Thus,
second connector 32 and the syringe 33 that carries it may be
retained in connection with connector 10, while flow is blocked
through the respective connectors 10, 32 by closed diaphragm 16.
Thus, the first and second connectors may be frictionally retained
in a retracted position while fluid flow is blocked through the
connectors. The inner diameter of skirt 30 may, for example, be
about 8.0 mm, with the maximum diameter of lugs 26 being about 8.3
mm.
[0042] The plastic material of particularly forward component 12 of
first connector 10 may have a flexural modulus that is low enough
to allow deformation at the dimensions used, permitting a
connected, engaging second connector to pop loose from first
connector 10 when laterally struck rather than breaking connector
10, so that first connector tube 20 can be briefly pushed into an
oval shape or the like. Specifically, a particular plastic that may
be used is a poly(styrene-methylmethacrylate) such as Zylar 530
having a flexural modulus of about 285,000 psi. Also, first
connector tube 20 may have an inner diameter of at least 5.5 mm
along its entire length so that its inner diameter is larger than
the outer diameter of second connector male luer tube 34 along
their lengths in their most advanced engaging position where skirt
30 abuts upper surface 45 (FIG. 10) of forward component 12 of
connector 10.
[0043] Fluid flow connector 10 may, for example, be carried on a
substantially rigid, pressure sensing chamber wall 44 (FIG. 1 1)
for an extracorporeal blood line or the like, with the pressure
sensing chamber and connector 10 comprising an integrally molded,
single piece, if desired.
[0044] First connector tube 20 also has a length of about 4.1 mm,
which is less than the length of the corresponding tapered bore
component of a conventional luer lock connector. This facilitates
the "pop-off" characteristic of the connector of this invention, as
illustrated in FIG. 11.
[0045] Also, first connector tube 20 has a wall thickness of about
0.8 mm which is thinner than typical luer lock connectors in
accordance with ANSI specifications. Thus, first connector tube 20
has more flexibility because of the thinner wall than a
corresponding component of a conventional female luer lock
connector of ANSI specification, and also because of the material
of relatively low flexural modulus from which first connector tube
20 is made. The entire connector 10 may be made of such material of
limited flexural modulus as described above, or rearward connector
body component 14 may be made of a different material, with forward
connector body component 12, and first connector tube 20 which
comprises a part thereof, being made of the plastic material
described above.
[0046] In FIG. 11, the results of lateral striking of syringe 33 is
shown, with connector 10 being attached to a stationary element,
for example wall 44 of substantially rigid pressure sensing chamber
for an extracorporeal blood line, or the like. It can be seen that,
because of the increased taper of the lumen of first connector tube
20, second connector tube (male luer) 34 can easily tip to an
extent, as shown. Also because of the preferred lack of frictional
connection between first and second connector tubes 20, 34, the
thinner wall of first connector tube 20, and the plastic material
from which it is made, under lateral pressure 41, by an inadvertent
striking, syringe 33 can tip and even separate without breaking
first connector tube 20 or second connector 32.
[0047] Syringe 33 can be tilted even further by pressure-distortion
of the lumen 21 of first connector tube 20 into an oval shape,
which can serve to facilitate disengagement of threads 28 from lugs
26, further facilitating the resultant pop-off, and separation of
the connection between connectors 10 and 32. Elastomeric diaphragm
16 spontaneously closes back through its original configuration,
providing sealing of the system from first, female connector 10 at
predetermined pressures, which typically include the operating
pressures of the system.
[0048] As a further advantage, because of the lesser wall thickness
of first connector tube 20, when compared with conventional luer
connectors of ANSI specification, the lumen within first connector
tube 20 may be wider than a conventional ANSI female luer
connector, which facilitates sterilization using an
antiseptic-soaked pad or the like. Similarly, second connector tube
34 may have sufficient exposure to permit swabbing with an
antiseptic-soaked cotton swab, so that the system may be manually
resterilized, and then reconnected in the event of an accidental
separation.
[0049] The above has been offered for illustrative purposes only,
and it is not intended to limit the scope of the invention of this
application, which is as defined in the claims below.
* * * * *