U.S. patent number 3,695,271 [Application Number 05/043,008] was granted by the patent office on 1972-10-03 for retention suture bridge.
This patent grant is currently assigned to Technalytics Incorporated. Invention is credited to Ingram S. Chodorow.
United States Patent |
3,695,271 |
Chodorow |
October 3, 1972 |
RETENTION SUTURE BRIDGE
Abstract
This invention is a retention-suture bridge designed to position
and secure a retention-suture above and out of contact with an
incision closure and suture exit points while maintaining lateral
fixation of the suture at the points where it exits the skin, and
thus effectively to join the corresponding tissue layers,
approximate the original marginal pressure of the skin and
underlying tissues, and ultimately prevent or reduce infection and
scarring.
Inventors: |
Chodorow; Ingram S. (New York,
NY) |
Assignee: |
Technalytics Incorporated (New
York, NY)
|
Family
ID: |
21924964 |
Appl.
No.: |
05/043,008 |
Filed: |
June 3, 1970 |
Current U.S.
Class: |
606/233 |
Current CPC
Class: |
A61B
17/0466 (20130101) |
Current International
Class: |
A61B
17/04 (20060101); A61b 017/04 () |
Field of
Search: |
;128/85,334R,335,335.5 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
I claim:
1. A bridge device for use with a retention suture looped about an
incision, the suture thus partially below the surface of the skin
with two exposed end parts of the suture extending out of and above
exit points in the skin, the bridge device (described with
reference to a side elevation view) comprising a longitudinal
central portion defining length, transverse breath, a bottom
surface, and two ends, and a foot portion at each end of the
central portion, each foot portion defining a body part with a
junction-end connected in abutment to one end of said central
portion of the bridge, a terminal end opposite the junction end,
and a contact surface extending along the bottom of the foot, the
bottom surfaces of the central portion and junction ends being
flush at said abutment connection, said feet being oriented such
that the entire contact surface of the body part and terminal end
of each foot is lower in elevation than the entire bottom surface
of the central portion of the bridge, the bridge further comprising
at least two suture receiving means spaced a selected distance
apart lengthwise on said central portion, said suture receiving
means each adapted to engage said exposed suture end part
(extending upward from an exit point) at a contact point along its
length, said receiving means thus maintaining said contact points
of said exposed suture end parts apart by said selected distance,
said contact surfaces of the feet being totally outward of said
suture receiving means on the central portion, whereby the bridge
is placeable upon the skin with its longitudinal axis generally
transverse to the incision, the exposed parts of the suture being
extendible from said exit points to said suture receiving means and
secured upon said central portion, thus maintaining the exposed
parts above the exit points out of contact with the skin.
2. A device according to claim 1 wherein the central and feet
portions comprise a one-piece construction.
3. A device according to claim 2 wherein the suture receiving means
comprise longitudinally spaced-apart slots disposed transversely
with respect to the longitudinal axis of the central portion, the
suture ends being receivable and retained apart in and by selected
slots.
4. A device according to claim 2 wherein the suture receiving means
comprise a plurality of openings spaced apart longitudinally along
the central portion, the suture ends being receivable and retained
apart in selected openings.
5. A device according to claim 1 wherein the bridge comprises two
complementary portions, relatively adjustable axially.
6. A device according to claim 1 wherein said contact surfaces are
generally flat and continuous.
7. A device according to claim 1 wherein said central and feet
portions of the bridge define a generally crescent-shaped arch.
8. A device according to claim 7 wherein said central portion is
curved thus defining a first radius of curvature, and wherein a
circle tangent to said feet portions would define a slightly
greater radius of curvature.
9. A device according to claim 1 wherein said end portions and
central portions of the bridge together comprise a generally flat
beam which is curved to define a generally flat plane, a
cross-section of the beam having greater width transverse to the
plane than height within the plane.
10. A device according to claim 1 wherein said suture-receiving
means comprises at least one pair of suture-receiving elements
spaced apart and defining a line that extends between and through
them lengthwise on said central portion.
11. A device according to claim 10 wherein said suture-receiving
means is formed by at least two apertures in said central
portion.
12. A device according to claim 1 wherein said obtuse angle is
about 145.degree..
13. A device according to claim 10 further comprising suture guide
means on said central portion intermediate said suture-engaging
elements.
14. A device according to claim 13 wherein the suture guide means
captively engages the suture.
15. A device according to claim 13 wherein the suture guide means
is formed as a tunnel through which the suture is threaded.
16. A device according to claim 13 wherein the suture guide means
is formed as a vertical peg extending up from the superior surface
and around which the suture can be tied.
17. A device according to claim 16 wherein the peg is undercut at
its base so that the diameter of superior portion of peg exceeds
the diameter of inferior portion around which the suture is tied
and secured.
18. A device according to claim 1 wherein the bridge has a flexible
part between the central portion and at least one end portion
permitting this end portion to pivot relative to the central
portion.
19. A device according to claim 18 wherein said flexible part is a
hinge joint.
20. A bridge device for use with a retention suture looped about an
incision, the suture thus partially below the surface of the skin
with two exposed end parts of the suture extending out of and above
exit points in the skin, the bridge device (described with
reference to a side elevation view comprising a longitudinal
central portion defining length, transverse breath, a bottom
surface, and two ends, and a foot portion at each end of the
central portion, each foot portion defining a body part with a
junction-end connected in abutment to one end of said central
portion of the bridge, a terminal end opposite the junction end,
and a contact surface extending along the bottom of the foot, the
bottom surfaces of the central portion and junction ends being
flush at said abutment connection, said feet being oriented such
that the entire contact surface of the body part and terminal end
of each foot is lower in elevation than the entire bottom surface
of the central portion of the bridge, the bridge further comprising
at least two suture receiving means spaced a selected distance
apart lengthwise on said central portion, said suture receiving
means each adapted to engage said exposed suture end part
(extending upward from an exit point) at a contact point along its
length, said receiving means thus maintaining said contact points
of said exposed suture end parts apart by said selected distance,
said contact surfaces of said feet being totally outward of said
suture receiving means on the central portion, the bridge further
comprising means on said central portion adjacent said suture
receiving means for engaging a part of the suture secured thereon
and varying the tension in said suture while the suture remains
secured, whereby the bridge is placeable upon the skin with its
longitudinal axis generally transverse to the incision, the exposed
parts of the suture being extendible from said exit points to said
suture receiving means and secured upon said central portion, thus
maintaining the exposed parts above the exit points out of contact
with the skin.
21. A device according to claim 20 wherein the means for varying
tension comprises a plurality of upstanding projections on an upper
surface of the bridge, the suture being selectively positionable
about at least one projection.
22. A bridge device for use with a retention suture looped about an
incision, the suture thus partially below the surface of the skin
with two exposed end parts of the suture extending out of and above
exit points in the skin, the bridge device (described with
reference to a side elevation view) comprising a longitudinal
central portion defining length, transverse breath, a bottom
surface, and two ends, and a foot portion at each end of the
central portion, each foot portion defining a body part with a
junction-end connected in abutment to one end of said central
portion of the bridge, a terminal end opposite the junction end,
and a contact surface extending along the bottom of the foot, the
bottom surfaces of the central portion and junction ends being
flush at said abutment connection, said feet being oriented such
that the planes extending generally along the two contact surfaces
of said feet intersect and define between them an obtuse angle that
diverges downward with the entire contact surface of the body part
and the terminal end of each foot being lower in elevation than the
entire bottom surface of the central portion, the bridge further
comprising at least two suture receiving means spaced a selected
distance apart lengthwise on said central portion, said suture
receiving means each adapted to engage said exposed suture end part
(extending upward from an exit point) at a contact point along its
length, said receiving means thus maintaining said contact points
of said exposed suture end parts apart by said selected distance,
said contact surfaces of the feet being totally outward of said
suture receiving means on the central portion, whereby the bridge
is placeable upon the skin with its longitudinal axis generally
transverse to the incision, the exposed parts of the suture being
extendible from said exit points to said suture receiving means and
secured upon said central portion, thus maintaining the exposed
parts above the exit points out of contact with the skin.
Description
In large abdominal incisions, successful closure generally requires
in addition to skin sutures at the exposed outer layers, the use of
transverse tension sutures, usually designated stay or retention
sutures, which are drawn through both sides of an incision, passing
through numerous layers of tissue, such as fascia, fat, muscle,
etc., so as to join each layer to its appropriate counterpart and
to hold severed tissue in juxtaposition. After closure the incision
area usually has certain swelling owing to edema caused by the
physical and chemical trauma of surgery, thus causing tightening of
the sutures. Body movement or muscular strain is likely to place
additional tension in the sutures.
In the typical cases where the sutures are allowed to maintain
contact with the skin under them, the strain and swelling results
in increased suture tension, with the suture impressing itself
deeply into the skin causing redness of erythema, infection which
slows or otherwise impairs healing, necrosis of tissue cells and/or
increased scarring and cross-hatching.
Various techniques and devices have been used in attempts to
obviate these problems. Initial attempts involved loose tying of
sutures to allow for swelling, but this left the incision not fully
and securely closed. In one class of devices widely and currently
used, a section of rubber catheter tubing is cut to a length the
same as the distance between suture exit points, with the exposed
portion of each suture threaded through the bore of a cut section.
Such devices have the disadvantage of failing to maintain lateral
fixation, because the flexible tubing buckles, with the additional
problem mentioned above, of pressure contact by the tube along its
length against the skin and particularly at the exit points. Rigid
tubes of fixed and varying length have been used; however, they
also bear along their length upon the skin surface, causing
cross-hatch scarring of considerable extent. Flat pieces of wood,
metal and plastic of fixed length with notches in opposite ends
have also been employed, but these have the same disadvantages as
rigid tubing. Another class of devices employs an arch with short
notches in opposite ends of its length. This device makes contact
with the skin at the suture exit points and throughout its length
with the resulting pressure, irritation, and scarring. A variation
of this technique involved a higher arch connecting two feet on
opposite sides with long notches located in its feet on opposite
ends directed toward each other. These notches transect the entire
foot, and the points where they stop provide a fixed distance. To
the extent that these latter devices actually contacted the suture
exit points, danger resulted of secondary infection caused by such
contact, and the use of notches at the ends of such a device did
not allow for variation of the distance between suture exit points
or variation in the distance between suture-receiving points. Also,
such notched devices are useable only on the class of sutures known
as figure-of-eight sutures, wherein the suture defines a lower and
an upper loop; such sutures form a lower loop about deep layers of
tissue, with the suture ends extending out of the skin in diverging
directions for forming the upper loop. The device cooperates by
pulling these suture ends in diverging directions which tightens
the lower loop, but allows the upper part of the incision within
the upper loop to remain loose or open with both a single loop or
figure-of-eight suture arrangement.
It is therefore a prime object of the present invention to provide
an improved suture retention device. It is a further object of the
present invention to provide an improved surgical suture retention
device which does not contact the incision area or the suture exit
points. It is a still further object of the present invention to
provide an improved surgical suture retention device which can
accommodate a variety of distances between suture exit points
without irritation of the skin at the suture exit points. It is
another object of the present invention to provide an improved
surgical suture retention device which provides a high degree of
stability and a construction admitting of positive body
contact.
The foregoing objects are carried into effect by a surgical
retention device structured as a bridge formed by an arch with feet
on opposing ends. In use, each end of a suture extends upward from
the skin, and is engaged at respective spaced points on the arch by
appropriate suture-receiving means, or specific suture-engaging
elements forming part of the arch. The distance between the points
on the arch at which the sutures can be received is adjustable as
desired for the various length and type of suture used. The entire
device makes contact with the skin only at the feet lateral to the
suture exit points.
In the preferred embodiment, several engaging means exist on each
side of a one-piece device so that the sutures can rise upward
directly to appropriate points on the bridge, even though the exit
points from the skin may be relatively close or wide-spaced. This
adaptability precludes the need for bridges of varying size. In a
further embodiment, a two-piece device is raised off the skin at
the central portion, and contains at least one suture receiving
means on either piece. The pieces are fittable with each other so
as to provide varying distances between the suture receiving means.
Across the central portion of the arch the suture ends are directed
toward each other, and tied together after both are pulled snugly
to create sufficient tension to draw skin and underlying tissues on
opposite sides of incision together.
In another embodiment, there is provided means on the bridge for
adjusting tension of the suture after it is tied. In a further
embodiment, there is a suture guide means for stabilizing the
portion of the suture situated atop the bridge.
The feet provided are preferably wider than the bridge area and
generally circular in shape, covered with a suitable compressible
material and angulated for firm and stable contact with the
underlying skin area.
The foregoing objects and brief description of the invention, as
well as, further objects and advantages of the invention, will
become more apparent from the following detailed description of
preferred and alternative embodiment of the invention wherein:
FIG. 1A is a perspective view of a preferred embodiment of a suture
bridge in accordance with the invention.
FIG. 1B is a cross-sectional view of the preferred embodiment of
FIG. 1a.
FIG. 1C is a perspective view of a modification of the device of
FIG. 1B.
FIG. 1D is a perspective view of another embodiment thereof.
FIG. 2 is a fragmentary plan view of a bridge.
FIG. 3 is similar to FIG. 2 with a different suture engaging
means.
FIG. 4 is a perspective view of a flat bridge with a
tension-adjusting means for the suture.
FIG. 5 is similar to FIG. 4 with a different tension-adjusting
means.
FIG. 6 is similar to FIG. 4 with another tension-adjusting
means.
FIG. 7 is a perspective view of a bridge with a suture-hooking
means.
FIG. 8 is a partial perspective view of a bridge with a
suture-guide means.
FIG. 9 is similar to FIG. 8 with a different suture-guide
means.
FIG. 10, 11, 12 and 12a are perspective views of four embodiments
of a two-piece suture bridge constructed in accordance with this
invention.
FIG. 13 is an elevation view of a bridge with pivotable feet.
FIG. 14 is a perspective view of a pair of bridges with a
stabilizer element.
With reference of FIGS. 1A, 1B, 1C, a bridge 10 is shown, having a
length of span capable of extending over an incision 12 located in
tissue layers 14, as shown schematically in FIG. 1B. The bridge is
constructed of a central portion 16, terminating at opposite ends
thereof with rounded feet members 18 and 20. The feet members 18
and 20 have body parts that are wider than the central portion 16
in a direction extending across the central portion 16.
The bridge 10 is arched along its length with a curvature suitable
for maintaining the central portion 16 Each foot has a junction-end
attached to one end of the central portion and an opposite terminal
end. out of contact with the skin 14. The planes of the feet
portions 18 and 20 extend substantially along the curve described
by the arch of the central portion 16 or along a slightly flatter
curve defined by a greater radius of curvature which corresponds to
certain surfaces of the body when a bridge of this type is applied.
The planes of the feet portions intersecting at an obtuse angle of
less than 180.degree. such as about 135.degree. in FIG. 1b the
under portions of the feet 18 and 20 are each covered with a
suitable spongy material 22 and 24 for softening contact between
the feet and the skin.
The central portion 16 includes a plurality of equally spaced
apertures 26A, B, C, D and 28A, B, C; D on each side of the center
30. As shown, three or more apertures are present upon each side of
the center, in greater or lesser proportions and spacings. The
apertures receive exposed suture ends directly from the suture exit
points in the skin surrounding the incision. The variation in
number and position of the apertures permit the bridge to be used
on many different incision closures despite considerable variation
in the location of suture exit points about the incision. Thus, the
sutures can be extended vertically or angled upward from the suture
exit points to corresponding apertures, or if the sutures are
convergent resulting from a single loop closure, the sutures would
be angulated as they approach the bridge. If a figure-of-eight
suture loop is chosen, then the suture ends would diverge before
engaging the apertures. In each case the suture ends are maintained
above and out of contact with the incision and the tissue between
and adjacent the exit points. Consequently contact and irritation
to this tissue is minimized or eliminated, with a corresponding
reduction of necrosis, infection, swelling, and scarring. Cleaning
of the now-exposed incision area is possible, healing is hastened,
and the patient's discomfort is greatly reduced.
Thus, by way of example in FIG. 1B, a suture 13 passes about the
incision 12 and emerges at suture exit points 13A and 13B. The
respective exposed suture ends emerging through these exit points,
pass through the apertures 26D and 28D which are spaced apart by a
selected distance, respectively positioned in the central portion
16 of the bridge 10 directly or at least generally above the suture
exit points 13A and 13B. The single inventive bridge unit is thus
shown to permit use of all of the foregoing suture techniques as
well as to accommodate the various suture exit point distances. In
all of the uses, the bridge never comes into contact with the
incision or a suture exit point.
The angle which the feet portions 18 and 20 present to the
horizontal plane is a further aid. Tensioning of the suture about
an incision 12 causes a certain natural bulge in the skin area 14
about the incision. The angulation of the feet combines with the
forced curvature of the skin to mate the flat under portion of the
surfacing 22 and 24 to the skin 14. The relatively even mating of
the under portion of the surfacing 22 and 24 to the skin 14 aids in
maintaining stability of the bridge by distributing the bridge
pressure substantially evenly over the entire area of the feet, and
prevents the bridge from tipping, as well as, distributing the
pressure of the bridge over a greater skin surface area, thereby
facilitating comfort. Also the natural direction of the pressure
applied by the feet 18 and 20 to the skin 14 further aids in
closing the incision 12 and thereby promotes healing.
The apertures of FIGS. 1A and 1B are preferably formed and
separated by tapered segments 30 having cylindrical cross-sections,
and thus narrower on the bottom and wider across the center, thus
facilitating ease of threading and presenting a rounded surface to
the suture.
The dome center piece 32 serves to strengthen the central portion
16 of the bridge as well as providing, through the use of a suture
tunnel, the central aperture 34, a convenient point to tie off the
suture. The suture tunnel 34 is preferably tapered and the suture
tie knot 35 made at the exit from the smaller opening. The smaller
opening prevents the suture tie knot 35 from slipping through.
The interior edges of the central portion 16, those closest to the
skin, are rounded to soften skin contact. It is noted that the
spongy pads 22 and 24 may be omitted, and that the slight
difference in angle between the feet 18 and 20 and the central
portion 16 will still maintain the curved central portion 16 above
and out of contact with the skin surface 14.
Summarizing the operation of the invention by way of example in
surgical procedures, a suture connected to a needle is sewn into
selected tissue layers about an incision, on one side thereof, to a
desired depth with respect to the incision and merges on the
opposite side, thus forming the suture into at least a partial loop
having a closed end and limbs extending therefrom. The suture limbs
extend generally upward through exit points in the tissue on
adjacent sides of the incision, with the exit points being at
preselected and observable distance apart. A corresponding distance
is determined between selected apertures in the suture bridge,
which is now placed over the incision so that the sutures may pass,
for example upward through the appropriate apertures 26 and 28 in
the bridge 10. Ease of threading is accomplished by the tapering of
the aperture separations 30 such that the apertures are larger on
the interior surface. Each aperture location serves as a holding
point to maintain the suture limb elevated above and out of contact
with the exit point, the incision, and tissue between and adjacent
the exit points. The limbs are directed toward each other, with one
of the suture ends passing through the tunnel in the dome 32 on the
top surface of the bridge to meet the other suture on the other
side. Threading through the tunnel 34 is facilitated by a tapering
of the tunnel 34, wider where suture 13 enters. The suture ends are
tied to one another at the point of exit from the tunnel so that
the tie knot 35 rests over the end of the tunnel with the smaller
hole. The feet of the suture bridge rest firmly on the skin lateral
to the exit points. The base of the feet apply the pressure of the
bridge equally to skin at all points owing to the angulation of the
skin upwards toward the incision from tension and corresponding
angulation of the feet downwards in a lateral direction. If the
feet were horizontal, only the inner part would contact the skin.
The bridge itself can be made of any suitable surgical material.
Preferably, the bridge is molded as an integral unit from a
suitable plastic such as methyl methacrylates which may be
chemically sterilized, or from a polypropylene which can be
sterilized in an autoclave.
In the embodiment of FIG. 1C, the apertures are replaced by tapered
holes, having the same function as the apertures. In the embodiment
of FIG. 1D, the feet portions 36 and 38 are joined to the central
portion 40 of the bridge by means of vertical upstanding portions
42 and 44.
Referring now to FIG. 2, the suture engaging means are slots 46
running transversely with respect to the longitudinal axis or the
length, of the bridge and located within the central portion of the
body member 48. The suture may be received and retained by selected
slots disposed above the suture exit points, or as close as
possible thereto, and out of contact with the skin. The slots may
be provided with an orthogonally positioned notch 50 for securing
the suture against lateral slippage, as shown in FIG. 3.
It is understood that the curvature of the central portion of the
bridge is designed for the purpose of maintaining the suture
engaging central portion out of contact with the underlying skin
area. The central portion containing the suture engaging or
receiving means can itself take any desired shape provided the
remainder of the central portion of the feet portions together
cause the suture engaging or receiving central portion to occupy a
position suitable raised from the skin surface so as to be out of
contact therewith.
Thus, as shown in FIG. 4, the suture retention means of the bridge
central portion is flattened as a beam having width considerably
greater than height (similarly in FIGS. 1-12), and includes a first
group of pegs 52 formed at the side of the support surface 53 and
another peg 54 formed on top of the surface 53. The suture 55 is
positioned in a desired pair of the suture receiving slots 56 and
by selective positioning about the pegs 52 and 54 can be adjusted
in tension as desired. The same effect can be accomplished by
providing a plurality of pegs 58 atop the slotted surface 53 as
shown in FIG. 5.
Referring to FIG. 6, a further embodiment of a suture tensioning
structure is shown having a superstructure 60 atop the slotted
surface 53. The superstructure is provided with a plurality of
parallel grooves 62 running the length of the superstructure and
adapted to receive the suture 55. By placement of the suture in
different grooves, the desired tensioning may be achieved.
Adjustment of the sutures can be accomplished with the structure
shown in FIG. 7. The slotted surface 53 is provided with edge pegs
64 and top pegs 66 for tensioning, as described in connection with
FIGS. 4 and 5. Upon one or preferably both sides of the pegs is
provided a rabbetted groove 68. The depth of the groove is
sufficient to permit insertion of a hook shaped tool 70 which can
raise the suture 55 and place it wherever desired tensioning
dictates.
The protrusion 32 shown in FIG. 1A, and useable for anchoring or
captively holding the suture, can be formed in different ways. In
FIG. 8, the peg or protrusion 72 is an upright cylinder around
which the suture 55 ties. In FIG. 9, the suture anchors to the post
74 which is formed of a domed post top and a rectangular slab lower
section formed on or mounted to the surface area 76 of the bridge.
The undercut area of the peg permits the suture to be tied off
without the danger of slippage.
In FIGS. 10, 11, 12 and 12A, a further embodiment of the bridge is
shown wherein the adjustable distance between suture receiving
means can be effected with only a single suture receiving means
located on either side of the bridge center. Specifically, the
bridge 78 includes first and second end segments 80 and 82 which
can include the feet portions at the outer ends as for example
described in FIG. 1A and 1D. Each end segment includes one suture
receiving means which may be in the form of slots 84 and 86
respectively, as shown in FIG. 10 and 12, or as apertures 88 as
shown in FIG. 11. The upper portion 80 shown in FIG. 10 attaches to
the lower portion 82 at variable points 90 by virtue of mating
strips and rabbetted grooves. Positive fit can be assured by
providing dovetailed mating, or the units can be formed with
rounded or rectangular grooves and mating strips and attached by
some suitable means such as tape, rubber straps, adhesive and the
like. In FIG. 11, the attachment is accomplished by formation of a
channel 92 running the length of the left hand piece 91, and having
transverse slots 94 in the upper portion thereof. Corresponding
pegs 96 can have a press or interference fit into a selected slot
94, thereby adjustably determining the distance between the suture
receiving apertures 88.
A further arrangement is illustrated in FIG. 12 wherein a saw tooth
pattern 98 in mating segments provides the adjustability of
distance between suture receiving points 84 and 86. The segments
can be secured together by the means discussed above, such as
rubber bands 104; the two segments can be made as telescoping or
threaded members such as tubes as shown in FIG. 12a.
A further embodiment, that is applicable to both one-piece and
two-piece bridges as in FIGS. 1C and 10 respectively, is flexible
feet. The junction 18a in FIG. 1C may be flexible, or this junction
may be formed as a pivot 18c in FIG. 13. This feature permits the
feet to accommodate different shapes while maintaining the exposed
suture out of contact with the closure.
In use, the suture retaining bridges are usually employed in a
series, FIG. 14 shows a plurality of bridges 106, 108 positioned
above on incision 110, with the slight angulation between feet
portion 112, 114 and the arched portion of the bridge; bar 116 may
be used to engage and stabilize the various bridges with respect to
each other and to the underlying skin.
The foregoing embodiments are intended as exemplary only, and
various further modifications as well as permutations and
combination of the foregoing described embodiments will be apparent
to those skilled in the art without departure from the spirit and
scope of the invention as defined herein.
* * * * *