U.S. patent application number 11/733261 was filed with the patent office on 2007-08-09 for electrode line.
This patent application is currently assigned to BIOTRONIK GMBH & CO. KG. Invention is credited to Gernot Kolberg.
Application Number | 20070185557 11/733261 |
Document ID | / |
Family ID | 33426889 |
Filed Date | 2007-08-09 |
United States Patent
Application |
20070185557 |
Kind Code |
A1 |
Kolberg; Gernot |
August 9, 2007 |
ELECTRODE LINE
Abstract
An implantable electrode line having a proximal and a distal
end, an outer electrode line surface and an electrode line
longitudinal axis. The implantable electrode line is characterized
in that the electrode line in the region of the distal end has a
surface region with a microstructure, the surface region being
provided for lateral contact with a vessel wall and being arranged
at a spacing relative to the distal end which measures a plurality
of electrode line diameters. The microstructure is formed by a
plurality of microstructure elements which are arranged on the
electrode line surface and which are distributed over the surface
region both in the longitudinal direction and also in the
peripheral direction. The microstructure elements are adapted, upon
contact with a vessel wall, to counteract displacement of the
electrode line along the electrode line longitudinal axis.
Inventors: |
Kolberg; Gernot; (Berlin,
DE) |
Correspondence
Address: |
HAHN LOESER & PARKS, LLP
One GOJO Plaza
Suite 300
AKRON
OH
44311-1076
US
|
Assignee: |
BIOTRONIK GMBH & CO. KG
Woermannkehre 1
Berlin
DE
12359
|
Family ID: |
33426889 |
Appl. No.: |
11/733261 |
Filed: |
April 10, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10883030 |
Jun 30, 2004 |
|
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11733261 |
Apr 10, 2007 |
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Current U.S.
Class: |
607/126 ;
607/116; 607/122 |
Current CPC
Class: |
A61N 1/057 20130101;
A61N 1/056 20130101 |
Class at
Publication: |
607/126 ;
607/122; 607/116 |
International
Class: |
A61N 1/05 20060101
A61N001/05 |
Foreign Application Data
Date |
Code |
Application Number |
Jul 4, 2003 |
DE |
103 31 106.8 |
Claims
1. An implantable electrode line comprising: a proximal end; a
distal end; an outer electrode line surface; and an electrode line
longitudinal axis, wherein the electrode line in a region of the
distal end includes a surface region with a microstructure, the
surface region being provided for lateral contact with a vessel
wall and being arranged at a spacing relative to the distal end
which measures a plurality of electrode line diameters, and wherein
the microstructure is formed by a plurality of microstructure
elements which are arranged on the electrode line surface and which
are distributed over the surface region both in a longitudinal
direction and also in a peripheral direction and which have a
component extending radially, wherein the microstructure elements
are of a radial extent which is a fraction of the electrode line
diameter and are adapted, upon contact with a vessel wall, to
counteract displacement of the electrode line along the electrode
line longitudinal axis.
2. The implantable electrode line as set forth in claim 1 wherein
the microstructure elements are in the form of microbristles,
wherein the microbristles are oriented at a predetermined angle
relative to the electrode line surface.
3. The implantable electrode line as set forth in claim 1 wherein
the microstructure elements are oriented in parallel relationship
with the electrode line longitudinal axis.
4. The implantable electrode line as set forth in claim 2 wherein
the microbristles are oriented in parallel relationship with the
electrode line longitudinal axis.
5. The implantable electrode line as set forth in claim 2 wherein
the microbristles are arranged at a predetermined angle relative to
the electrode line surface and are respectively oriented in
mutually parallel relationship at a predetermined angle relative to
the electrode line longitudinal axis.
6. The implantable electrode line as set forth in claim 3 wherein
the microstructure elements are arranged at a predetermined angle
relative to the electrode line surface and are respectively
oriented in mutually parallel relationship at a predetermined angle
relative to the electrode line longitudinal axis.
7. The implantable electrode line as set forth in claim 4 wherein
the microbristles are arranged at a predetermined angle relative to
the electrode line surface and are respectively oriented in
mutually parallel relationship at a predetermined angle relative to
the electrode line longitudinal axis.
8. The implantable electrode line as set forth in claim 2 wherein
the microbristles are oriented with a directional component facing
towards the proximal end of the electrode line.
9. The implantable electrode line as set forth in claim 3 wherein
the microstructure elements are oriented with a directional
component facing towards the proximal end of the electrode
line.
10. The inplantable electrode line as set forth in claim 4 wherein
the microbristles are oriented with a directional component facing
towards the proximal end of the electrode line.
11. The implantable electrode line as set forth in claim 5 wherein
the microbristles are oriented with a directional component facing
towards the proximal end of the electrode line.
12. The implantable electrode line as set forth in claim 6 wherein
the microstructure elements are oriented with a directional
component facing towards the proximal end of the electrode
line.
13. The implantable electrode line as set forth in claim 7 wherein
the microbristles are oriented with a directional component facing
towards the proximal end of the electrode line.
14. The implantable electrode line as set forth in claim 1 wherein
the electrode line surface comprises the microstructure
elements.
15. The implantable electrode line as set forth in claim 1 wherein
the electrode line surface does not comprise the microstructure
elements.
16. An implantable electrode line comprising: a proximal end; a
distal end; an outer electrode line surface; and an electrode line
longitudinal axis, wherein the electrode line in a region of the
distal end includes a surface region with a microstructure, the
surface region being provided for lateral contact with a vessel
wall and being arranged at a spacing relative to the distal end
which measures a plurality of electrode line diameters, and wherein
the microstructure is formed by a plurality of microbristles which
are arranged on the electrode line surface and which are
distributed over the surface region both in a longitudinal
direction and also in a peripheral direction and which have a
component extending radially, wherein the microbristles are of a
radial extent which is a fraction of the electrode line diameter
and are adapted, upon contact with a vessel wall, to counteract
displacement of the electrode line along the electrode line
longitudinal axis.
17. An implantable electrode line comprising: a proximal end; a
distal end; an outer electrode line surface; and an electrode line
longitudinal axis, wherein the electrode line in a region of the
distal end includes a surface region with a microstructure, the
surface region being provided for lateral contact with a vessel
wall and being arranged at a spacing relative to the distal end
which measures a plurality of electrode line diameters, and wherein
the microstructure is formed by a plurality of scales which are
arranged on the electrode line surface and which are distributed
over the surface region both in a longitudinal direction and also
in a peripheral direction and which have a component extending
radially, wherein the scales are of a radial extent which is a
fraction of the electrode line diameter and are adapted, upon
contact with a vessel wall, to counteract displacement of the
electrode line along the electrode line longitudinal axis.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS/INCORPORATION BY
REFERENCE
[0001] This U.S. Patent Application is a continuation of U.S.
patent application Ser. No. 10/883,030 filed on Jun. 30, 2004 which
claims priority to and the benefit of German patent application 103
31 106.8 filed Jul. 4, 2003.
TECHNICAL FIELD
[0002] Certain embodiments of the present invention relate to
implantable electrode lines. More particularly, certain embodiments
of the present invention relate to an implantable electrode line
having a proximal and distal end, an outer electrode line surface
and an electrode line longitudinal axis.
BACKGROUND
[0003] Electrode lines, for example for cardiac pacemakers, suffer
from the problem of electrode dislocations. Previous solutions for
fixing an electrode line in the heart and in vessels are for
example pre-shaped electrode lines which brace the electrode in
vessels. Also known are helixes or screws which are disposed at the
distal end of the electrode line on the electrode and which are
adapted to fix the electrode to a myocardium by screwing therein.
Also known are openings in the distal region of an electrode line,
which are adapted to anchor the electrode line in the trabecula
arrangement of a cardiac chamber.
[0004] The state of the art also includes hooks which are disposed
at the distal end or on the electrode line and which are adapted to
fix the electrode line to the myocardium.
[0005] The applicants' patent application WO97/31678 describes an
electrode arrangement having a ventricular electrode which has
hook-shaped fixing means at the distal end of the electrode.
[0006] DE 69430417 T2 discloses an electrode system in which the
electrode line is of a flexible nature in order to form a loop
between the atrial electrode and the ventricular electrode. In the
proximity of the atrial electrodes that electrode line has a first
passive fixing device in the form of hooks and in the proximity of
the ventricular electrodes at the distal end it has a fixing device
with two hooks.
[0007] Further limitations and disadvantages of conventional,
traditional, and proposed approaches will become apparent to one of
skill in the art, through comparison of such systems with the
present invention as set forth in the remainder of the present
application with reference to the drawings.
SUMMARY
[0008] In accordance with an embodiment of the present invention,
an implantable electrode line is provided which permits secure
fixing of the electrode line in the heart and in vessels.
[0009] Such an embodiment is attained by an electrode line of the
kind set forth in the opening part of this specification, which in
the region of the distal end has at least one surface region with a
microstructure, the surface region being provided for lateral
contact with a vessel wall and being arranged at a spacing relative
to the distal end which measures a plurality of electrode line
diameters. The microstructure is formed by a plurality of
microstructure elements which are arranged on the electrode line
surface and which are distributed over the surface region both in
the longitudinal direction and also in the peripheral direction and
which extend with a radial directional component, preferably
outwardly. The microstructure elements are of a radial extent which
is a fraction of the electrode line diameter and are adapted, upon
contact with a vessel wall, to counteract displacement of the
electrode line along the electrode line longitudinal axis.
[0010] The advantage of such an electrode line is that many
microstructure elements which measure a fraction of the electrode
line diameter and which are distributed on a surface region of the
electrode line afford a greater degree of adhesion than for example
in the case of an electrode line which has only one or some hooks
at the surface for fixing the electrode line.
[0011] In an embodiment of the present invention, the
microstructure elements are in the form of microbristles, wherein
the microbristles are arranged at a predetermined angle relative to
the electrode line surface. The angle can be for example
90.degree.. This advantageously provides that the electrode line is
secured against longitudinal axial displacement equally in the
direction of the proximal end and also in the direction of the
distal end.
[0012] In a further embodiment, the microbristles are arranged in
parallel relationship with the electrode line longitudinal axis,
and in a particularly preferred feature the microbristles are
oriented with a directional component facing towards the proximal
end of the electrode line. This advantageously provides that the
electrode line can be easily introduced in the implantation
procedure and an increased level of resistance to displacement of
the electrode line towards the proximal end is afforded by the
orientation towards the proximal end. As an alternative to this
embodiment a microstructured surface region may have both
microstructure elements which are oriented with a directional
component facing towards the proximal end and also such
microstructure elements which are oriented with a directional
component facing towards the distal end of the electrode line.
Preferably the microbristles are oriented along the longitudinal
axis of the electrode line alternately with a proximal and a distal
directional component. That advantageously provides for fixing of
the electrode line in respect of displacement along the
longitudinal axis of the electrode line, both in a direction
towards the proximal end of the electrode line and also in a
direction towards the distal end thereof.
[0013] In another alternative embodiment of the present invention,
the microbristles are arranged at a predetermined angle relative to
the electrode line surface and are each oriented in mutually
parallel relationship at a predetermined angle relative to the
longitudinal axis of the electrode line. In this embodiment the
microbristles are preferably oriented with a directional component
facing towards the proximal end of the electrode line. That
advantageously provides that the electrode line can be screwed into
a vessel by rotation about the longitudinal axis in the peripheral
direction. Preferably the bristles are adapted to bear flat against
the electrode surface in the screwing-in operation. A rotational
movement in opposite relationship to the screwing-in direction
provides for fixing of the electrode line, repeated rotational
movement in the screwing-in direction causes release of the
electrode line.
[0014] Alternatively the microstructure elements are in the form of
knobs which are adapted to cling to a vessel wall by adhesion. For
that purpose the knobs preferably have a flat adhesion surface
which is arranged perpendicularly to the radial direction of the
electrode line. When coming into contact with a suitable pressure
against a vessel wall, a sufficiently thin film of moisture can be
produced between the adhesion surface and the vessel wall. That
produces adhesion forces which fix the electrode line to the vessel
wall.
[0015] In a further preferred feature the knobs are in the form of
suction cups. For that purpose, instead of the flat adhesion
surface, the knobs may have a concavely shaped adhesion
surface.
[0016] In another embodiment the microstructure elements are in the
form of scales with a scale edge. Preferably the scales are
arranged at a predetermined angle, further preferably an acute
angle, relative to the electrode line surface, in such a way that
the scale edge is spaced from the surface of the electrode line. In
a further preferred feature the scales are arranged in such a way
that at least one edge portion of the scale edge has an
orientational component extending perpendicularly to the
longitudinal axis of the electrode line. This advantageously
provides that, on coming into contact with a vessel wall, the
electrode line is easily displaceable in one direction along the
longitudinal axis of the electrode line while in the direction
opposite thereto, by virtue of the scale edges engaging into the
vessel wall, there is an increased level of resistance to
longitudinal axial displacement.
[0017] In a further embodiment, the scales have at least one prong
or tooth at the scale edge. That prong can advantageously engage
into the vessel wall, in addition to the scale edge, and thus
provide a further increased level of resistance to longitudinal
axial displacement.
[0018] The microstructure elements can be disposed on or shaped
from the surface of the electrode line. Preferably the
microstructure is produced in a microstereolithographic process,
for example by deposition on a substrate. The substrate can be
applied to the electrode line surface or may be formed by the
electrode line surface itself. Alternatively a surface region with
a microstructure may also be produced by a
microstereolithographically produced form.
[0019] An electrode line may have one or more surface regions with
a microstructure, in which respect an embodiment or a combination
of various embodiments of microstructure elements such as for
example microbristles, scales, knobs or the embodiments of
microstructure elements illustrated in the Figures can be
implemented on just one electrode line.
[0020] Suitable materials for the electrode line are for example
polytetrafluoroethylene (PTFE), silicone, polyimide, ethylene
chlorotrifluoroethylene, ethylene tetrafluoroethylene (ETFE),
polypropylene or polyurethanes. The microstructures can be produced
jointly with the electrode line or a portion of the electrode line
in an injection molding process, in which respect the
microstructures can be appropriately incorporated in an injection
molding mold.
[0021] For easy introduction of the electrode line into a lumen, an
electrode line may have a longitudinally axially displaceable
sheath which can be arranged on the electrode line in such a way as
to cover the microstructure and, in the situation of use, to
release the microstructure by retraction in a proximal
direction.
[0022] These and other advantages and novel features of the present
invention, as well as details of an illustrated embodiment thereof,
will be more fully understood from the following description and
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] The invention will now be described in greater detail with
reference to the Figures.
[0024] FIG. 1 shows the distal end of an electrode line having an
electrode line surface and surface regions which each have a
respective microstructure,
[0025] FIG. 2 shows various embodiments of microstructure
elements,
[0026] FIG. 3 shows an arrangement by way of example of
microbristles on an electrode line,
[0027] FIG. 4 shows portions of an electrode line with various
embodiments of microstructure elements which are in the form of
scales,
[0028] FIG. 5 shows diagrammatically illustrated embodiments of
knobs, and
[0029] FIG. 6 shows an embodiment in which an electrode head is
cord-connected to a distal end of an electrode line by way of a
connecting line.
DETAILED DESCRIPTION
[0030] FIG. 1 diagrammatically shows the distal end of an electrode
line 100 having an electrode line surface 101 and surface regions
105 and 106 which each have a respective microstructure. The
surface region 105 is arranged at a spacing 104 from an electrode
103 disposed at the distal end of the electrode line. The surface
region 105 with a microstructure occupies only a part of the
surface of the electrode line, in the peripheral direction. In this
example, the drawing also shows a peripherally extending surface
region 106 which covers the outer electrode line surface 101 over
the entire peripheral direction. In this embodiment the surface
region 106 is arranged at a spacing 102 from the electrode 103 at
the distal end. FIG. 1 shows two alternative configurations of
surface regions--peripherally extending therearound and not
extending therearound--jointly on one electrode line. An electrode
line in accordance with the invention may have at least one surface
region 106 extending entirely therearound in the peripheral
direction of the electrode line or at least one surface region 105
which does not extend entirely therearound.
[0031] As an alternative thereto, an electrode line in accordance
with the invention may have a plurality of surface regions 106
extending entirely therearound in the peripheral direction of the
electrode line or a plurality of surface regions 105 which do not
extend entirely therearound. A combination of surface regions 106
extending entirely around the electrode line and surface regions
105 which do not extend entirely therearound, on an electrode line,
afford various alternative configurations which are not illustrated
here. The spacings 102 and 104 may both amount to several electrode
line diameters 110 and are diagrammatically illustrated in this
example. The surface regions 106 and 105 have a microstructure, the
microstructure being formed by a plurality of microstructure
elements which are arranged on the surface of the electrode line
and which are distributed over the surface region both in the
longitudinal direction and also in the peripheral direction.
Various embodiments of microstructure elements are illustrated
hereinafter in FIG. 2.
[0032] FIG. 2 shows a diagrammatic illustration of various
embodiments of microstructure elements. Those microstructure
elements are of a radial extent beyond the surface of the electrode
line, said extent being a fraction of the electrode line diameter.
The microstructure elements are adapted to counteract displacement
of the electrode line in the longitudinal direction, when they are
in contact with a vessel wall.
[0033] Provided on the electrode line surface 201 are for example
microstructure elements 203 which are in the form of curved
microbristles. The microbristles 203 are curved with a directional
component facing in the proximal direction 215. As a result, upon
displacement of the electrode line in the proximal direction 215,
the microbristles 203 produce an increased level of resistance to
displacement of the electrode line in the distal direction 216.
[0034] The microbristles can also be in the form of straight
microbristles 205. These straight microbristles 205 are arranged at
a predetermined angle relative to the surface 201 of the electrode
line, in such a way that they have an orientational component in
the proximal direction 215.
[0035] The microbristles 207 are also straight and are arranged in
perpendicular relationship to the electrode line surface 201. That
provides for an equally high level of resistance upon displacement
of the electrode line in the proximal direction 215 and in the
distal direction 216.
[0036] The microbristles 209 are disposed on the electrode line
surface 201 and, at the end remote from the electrode line surface
201, have a hook 210 which is shaped in the proximal direction 215.
The hook 210 is adapted to engage into a vessel wall upon
displacement of the electrode line in the proximal direction 215
and thereby to produce a particularly high level of resistance to
displacement of the electrode line in the proximal direction
215.
[0037] The microbristles 211, like the microbristles 203, are also
curved in the proximal direction 215 and, at the end remote from
the electrode line surface 201, have a star-shaped branching
configuration 212. By virtue of that configuration, upon coming
into contact with a vessel wall, the microbristles 211 can
particularly effectively engage into same and thereby produce a
high level of resistance to displacement of the electrode line in
the proximal direction 215.
[0038] FIG. 3 diagrammatically illustrates an embodiment by way of
example of microbristles on an electrode line. FIG. 3 illustrates
portions of an electrode line 300, on the electrode line surface
301 of which are disposed microbristles. The microbristles 303 are
oriented at a predetermined angle relative to the electrode line
surface 301 with a directional component in the proximal direction
215.
[0039] In a further example microbristles 305 are arranged at a
predetermined angle relative to the electrode line surface 301 and
are oriented with a directional component in the proximal direction
215. The microbristles 305 are also oriented in respective mutually
parallel relationship at a predetermined angle relative to the
longitudinal axis of the electrode line so that, upon rotational
movement of the electrode line in the peripheral direction 309 the
microbristles 305 are anchored in a vessel wall when in contact
therewith. Upon rotational movement of the electrode line in the
direction 310 opposite to the peripheral direction 309 the
microbristles 305 can be released from the condition of being
anchored in the vessel wall again.
[0040] The microbristles 307 are arranged orthogonally on the
electrode line surface 301. By virtue of that arrangement, an
equally high level of resistance is opposed to displacement
movement upon displacement of the electrode line in the proximal
direction 215 and also upon displacement of the electrode line in
the distal direction 216.
[0041] FIG. 4 diagrammatically shows portions of an electrode line
400 with various embodiments of microstructure elements which are
in the form of scales. The embodiments illustrated in FIG. 4 are
shown in part jointly on one electrode line portion. An electrode
line may have a respective one of the illustrated alternative
configurations or a combination of various alternative
configurations.
[0042] The scales 403 are oriented at a predetermined angle
relative to the electrode line surface 401 in the proximal
direction 215. The scales 403 have an edge which extends in
perpendicular relationship to the longitudinal axis of the
electrode line and which has a toothed configuration 402. That
toothed configuration is adapted to particularly effectively engage
into a vessel wall and be anchored therein, upon displacement of
the electrode line in the proximal direction 215.
[0043] In a further example, scales 405 with a round edge are
arranged in mutually juxtaposed relationship extending around an
electrode line in the peripheral direction thereof. The scales 405
form rings on the electrode line surface 401, which are spaced from
each other. Shown further to the right on that portion is an
embodiment in which scales 407 with a rounded-off edge are arranged
in such a way that scales which occur in succession in the
longitudinal axial displacement are respectively displaced relative
to each other in the peripheral direction by half a scale width.
Also arranged on the portion in the peripheral direction in
mutually juxtaposed relationship are scales 409 with a round scale
edge, wherein the scale edge has prongs 411 which are oriented in
the proximal direction 215 at at least one edge portion extending
in the peripheral direction. Alternative configurations (not shown)
of an electrode line can include a respective one of the
alternative scale configurations 405, 407 or 409. A combination of
the alternative scale configuration 409 with the alternative scale
configuration 407 on one electrode line or a combination of the
alternative scale configuration 409 with the alternative scale
configuration 405 on one electrode line are possible alternative
embodiments.
[0044] FIG. 5 diagrammatically illustrates embodiments of knobs.
The knob embodiments 502 and 503 are disposed on an electrode line
surface 501 and in this example are diagrammatically illustrated in
a side view as a section.
[0045] The knob 507 is in the form of a portion of a cylinder and
has a circular adhesion surface 508 which is adapted to cling to a
vessel wall by adhesion.
[0046] The knobs 502 and 503, like the knob 507, can be of a
cylindrical configuration. In the case of the knob shape 502 the
adhesion surface 504 is flat. In the case of the knob 503 the
adhesion surface 505 is of a concave shape and is thus in the form
of a suction cup.
[0047] In a variant design (not shown), as an alternative to the
circular shape, the adhesion surface can also be in the form of a
polygon.
[0048] An electrode line in accordance with various embodiments of
the present invention can have a combination of surface regions
which extend entirely therearound or which do not extend entirely
therearound, with any respective combination of the above-indicated
alternative configurations of microstructure elements in the form
of microbristles, scales or knobs.
[0049] A further development of the invention is diagrammatically
illustrated in FIG. 6. In this embodiment an electrode head 607 is
cord-connected to the distal end of an electrode line by way of a
connecting line 605. In the region of the distal end 600 the
electrode line has a surface region 603 with a microstructure. In
this example the surface region 603 is of such a nature as to
extend around the electrode line in the peripheral direction. in
this embodiment the connecting line 605 is sealed off in relation
to the electrode line body at the distal end thereof by a sealing
mass 604, for example a silicone sealing mass. Both the electrode
607 and also the surface region 603 at the distal end 600 of the
electrode line have a microstructure 603 formed by microstructure
elements. The microstructure elements of the microstructure 602 are
preferably of an electrically conductive nature, for example the
electrode head 607 may contain the electrode line material and have
a gold or platinum layer at the surface thereof. The gold or
platinum layer can be applied by vapor deposition or sputtering.
This embodiment advantageously permits a relative movement along
the longitudinal axis of the electrode line between the electrode
head 607 and the distal end 600 of the electrode line. The
microstructure elements of the microstructures 602 and 603 can be
embodied in the form of microbristles, knobs or scales in one of or
a combination of the above-described embodiments and arrangements.
In an alternative embodiment (not shown) the electrode line,
similarly to FIG. 6, has an electrode head which does not have any
microstructure. The electrode head is thus in the form of a freely
floating electrode, preferably in the form of a ventricular
electrode.
[0050] In a development of the invention the microstructure of the
surface region of the electrode line is such that body tissue can
grow into the surface region.
[0051] While the invention has been described with reference to
certain embodiments, it will be understood by those skilled in the
art that various changes may be made and equivalents may be
substituted without departing from the scope of the invention. In
addition, many modifications may be made to adapt a particular
situation or material to the teachings of the invention without
departing from its scope. Therefore, it is intended that the
invention not be limited to the particular embodiment disclosed,
but that the invention will include all embodiments falling within
the scope of the appended claims.
* * * * *