U.S. patent number 3,704,712 [Application Number 05/027,362] was granted by the patent office on 1972-12-05 for dilator device.
Invention is credited to Jerry D. Giesy, Jack M. Schneider, Gordon E. Smith.
United States Patent |
3,704,712 |
Giesy , et al. |
December 5, 1972 |
DILATOR DEVICE
Abstract
A dilator device comprising a first elongated member having a
handle-forming portion at one end thereof and a dilating portion in
front of said handle-forming portion which dilating portion has a
greatly elongated cross-section, and a second elongated member
confronting and extending generally parallel to said dilating
portion of said first member and having a greatly elongated
cross-section similar in shape and orientation to that of the
dilating portion of said first member. Links interconnect the
second elongated member and the dilating portion of the first
member so the longitudinal shifting of the second elongated member
will move the second member from a position immediately contiguous
to the dilating portion of said first member to a position where it
is spaced a relatively large distance therefrom. Operating means
are connected to the rear end portion of the second member which
means is engageable by the thumb of the hand grasping said
handle-forming portion to shift the second member
longitudinally.
Inventors: |
Giesy; Jerry D. (Portland,
OR), Smith; Gordon E. (Madison, WI), Schneider; Jack
M. (Denver, CO) |
Family
ID: |
21837277 |
Appl.
No.: |
05/027,362 |
Filed: |
April 10, 1970 |
Current U.S.
Class: |
606/198; 606/193;
606/197 |
Current CPC
Class: |
A61M
29/02 (20130101) |
Current International
Class: |
A61M
29/00 (20060101); A61m 029/00 () |
Field of
Search: |
;128/17,18,19,303.11,303.12,341,342,343,344,345 ;46/17 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Pace; Channing L.
Claims
We claim:
1. A dilator device for dilating constricted passageways in animals
and humans, said device comprising: at least two relatively
separable generally parallel bars adapted when brought into
contiguous relation to be passed into a constricted passageway,
links extending between and hinged at both ends thereof to said
parallel bars at longitudinally spaced pivot points therealong for
pivotal movement about pivot axes at right angles to the spacing of
the bars, the links extending across the width of the bars and the
lengths thereof being shorter than the spacings between the pivot
points on each of the bars so the bars can be moved from relatively
contiguous positions where the links are sandwiched between the
bars without overlap in positions where they extend parallel to the
bars, to relatively spaced apart positions where said passageway is
dilated, said links when the bars are in their maximum spaced
position being spaced apart a distance less than twice the length
of the links to form a cage for holding loose tissue outside of the
closely confronting surfaces of the bars when the bars are forced
into their contiguous positions while in said constricted
passageway, and means for moving said bars between said relatively
contiguous and spaced apart positions.
2. The dilator device of claim 1 wherein said links when said bars
are in said spaced apart positions are spaced apart a distance not
greater than about the order of magnitude of the separation
distance of said bars in said spaced apart positions.
3. The dilator device of claim 1 wherein the device is provided
with handle means extending from one of the ends of the bars for
grasping the dilator device, and means at the latter ends of the
bars and in front of the handle means positioned to be operated by
part of the same hand which grasps said handle means, selectively
to move said bars between said relatively contiguous and spaced
apart positions.
4. A dilator device for dilating constricted passageways in animals
and humans, said device comprising: at least two relatively
separable generally parallel bars adapted when brought into
contiguous relation to be passed into a constructed passageway,
links extending between and hinged at both ends thereof to said
parallel bars at longitudinally spaced pivot points therealong for
pivotal movement about pivot axes at right angles to the spacing of
the bars, the lengths of the links being shorter than the spacings
between the pivot points on each of the bars so the bars can be
moved from relatively contiguous positions where the links are
substantially sandwiched between the bars without overlap in
positions where they extend parallel to the bars, to relatively
spaced apart positions where said passageway is dilated, said bars
having parallel confronting surfaces spaced from the longitudinal
side margins of the bars by gradually rounded corners wherein the
points at which the bars come close together when they are in their
relatively contiguous position are located substantially inwardly
of the longitudinal side margins of the bars, to minimize the
possibility of pinching loose tissue between the bars.
5. A dilator device for dilating constricted passageways in animals
and humans, said device comprising: only two relatively separable
generally parallel bars separable transversely of one another and
having confronting dilating portions adapted when brought into
contiguous relation to be passed into a constricted passageway, the
dilating portion of each of said bars having a substantially
elongated cross-section in a direction transverse to the direction
of relative movement thereof, so the long dimension thereof is much
more than twice the shorter dimension transverse thereto, wherein
said bars when in said relatively contiguous positions occupy an
overall elongated space whose long axis extends in a direction
transverse to the direction of the separation thereof and is at
least about twice as long as its short axis, and means for moving
said bars to relatively spaced apart positions where said
constricted passageways will be expanded in the direction of the
separation of the bars.
6. The dilator device of claim 5 wherein the opposite
non-confronting exterior surfaces of said bars are rounded surfaces
which fall approximately along the same circle when said bars are
in substantially spaced apart passageway dilating positions.
7. The dilator device of claim 5 wherein said bars have parallel
confronting surfaces spaced from the longitudinal side margins of
the bars by gradually rounded corners wherein the points at which
the bars come close together when they are in their relatively
contiguous position are located substantially inwardly of the
longitudinal side margins of the bars.
8. The dilator device of claim 5 wherein there is a flexible
forwardly tapering nose portion in front of said bars for guiding
the device into a human male or female urethra, and said bars being
sized to enter and dilate a human male and female urethra.
9. A dilator device for dilating constrictive passage-ways in
animal and humans, said device comprising at least two relatively
separable generally parallel bars adapted when brought into
contiguous relation to be passed into a constricted passageway,
links extending between the confronting surfaces of and hinged to
said parallel bars so the bars can be moved by the relative
longitudinal shifting thereof from relatively contiguous positions
to spaced apart positions, said bars and said links being a single
integrally molded synthetic plastic part where the hinges between
the links and the bars are thin sections of plastic material, and
manually operable means for moving said bars between said
relatively contiguous and spaced apart positions.
10. The dilator device of claim 9 wherein said links extending
between the bars are spaced so close together that they form a cage
for holding loose tissue outside of the closely confronting
surfaces of the bars when the bars are returned to their relatively
contiguous positions while in said constricted passageway, said
links having a length permitting separation of said bars to dilate
said constricted passageway, and, when said bars are in said
relatively contiguous positions, said links being sandwiched
between the confronting surfaces of said bars and being in
separated but closely contiguous relation.
11. The dilator device of claim 9 wherein said separable bars and
links are molded in their spaced apart positions so the resiliency
thereof urges the bars to their spaced apart positions, said
manually operable means being mounted for normal unhindered
movement so the operator can feel the opposition to the separation
of the bars of the movement of said manually operable means, and
means for holding said manually operable means in the position
which adjust said bars to said contiguous positions so the device
can be inserted into a constricted passageway without applying any
force to said manually operable means.
12. The dilator device of claim 9 wherein there are only two
relatively separable generally parallel bars where each bar has a
substantially elongated cross-section in a direction transverse to
the direction of relative movement thereof, so the long dimension
thereof is much more than twice the shorter dimension transverse
thereto, said bars when in said relatively contiguous positions
occupying an overall elongated space having a long axis at least
about one and a half times as long as the short axis thereof, and
said links being of such a length that when the bars are in said
relatively maximum spaced apart positions the bars are separated an
order of magnitude similar to the longest cross-sectional dimension
of each of the bars, so the constricted passageway will then be
expanded in the direction of separation of the bars.
13. A dilator device for dilating constricted passageways in
animals and humans, said device comprising at least two relatively
separable generally parallel bars adapted when brought into
contiguous relation to be passed into a constricted passageway,
said bars being separable to bring the same to maximum spaced apart
positions where the passageway is dilated to a maximum degree
thereby, said device having a forwardly tapering nose portion in
the front of said relatively separable bars for guiding the device
into and through said constricted passageway, and the front of said
nose portion terminating in a longitudinally extending
screw-threaded portion of less diameter than the contiguous end of
the nose portion of the device and having rounded corners viewed in
section to provide an imperfect screw thread so the screw-threaded
portion will not cut or injure said constricted passageway when
pushed therethrough said screw thread being adapted to receive a
tapered attachment of smaller size than said nose portion for
forming a tapered extension of the nose portion.
14. The dilator device of claim 13 in combination with said tapered
attachment, said attachment having a threaded socket of somewhat
smaller size than said screw-threaded portion of said dilator
device and being of a material which will form relatively sharp
corners on said screw-threaded portion when threaded thereover, to
form a secure interconnection between the nose portion of the
dilator device and the attachment.
15. A dilator device for dilating constricted passageways in
animals and humans, said device comprising: a first elongated
member having a dilating portion adapted to enter the constricted
passageway to be dilated and a handle-forming portion forming a
rigid longitudinal extension of the rear end of said dilating
portion, said handle-forming portion of said first elongated member
adapted to be firmly held in the palm of one hand of the user with
the thumb thereof pointing forwardly along the length of the member
and free to manipulate the device, a second elongated member having
a dilating portion also adapted to enter said constricted
passageway to be dilated and confronting and extending generally
parallel to said dilating portion of said first member on the side
thereof on which said thumb will extend, links interconnecting said
second elongated member and the passageway dilating portion of said
first member and pivoted thereto along lateral transverse axes so
the longitudinal shifting of said second elongated member will move
the second member from a position immediately contiguous to said
passageway dilating portion of said first member to a position
where it is spaced a relatively large distance therefrom, and
operating means connected to the rear end of said second member
which means is engageable by the thumb of the hand grasping the
handle-forming portion of said first member when said second member
is contiguous to said passageway dilating portion of said first
member and is forwardly pushable thereby to shift said second
member longitudinally forwardly to bring the same into said
position where said second member is substantially spaced
therefrom.
16. A dilator device for dilating constricted passageways in
animals and humans, said device comprising: a first elongated
member having a dilating portion adapted to enter the constricted
passageway to be dilated and a handle-forming portion forming a
rigid extension of the rear end of said dilating portion, said
handle-forming portion of said first elongated member adapted to be
firmly held in the palm of one hand of the user with the thumb
thereof pointing forwardly along the length of the member and free
to manipulate the device, a second elongated member having a
dilating portion also adapted to enter said constricted passageway
to be dilated and confronting and extending generally parallel to
said dilating portion of said first member on the side thereof on
which said thumb will extend, links interconnecting said second
elongated member and the passageway dilating portion of said first
member and pivoted thereto along lateral transverse axes so the
longitudinal shifting of said second elongated member will move the
second member from a position immediately contiguous to said
passageway dilating portion of said first member to a position
where it is spaced a relatively large distance therefrom, and
operating means connected to the rear end of said second member
which means is engageable by the thumb of the hand grasping the
handle-forming portion of said first member when said second member
is contiguous to said passageway dilating portion of said first
member and is forwardly pushable thereby to shift said second
member longitudinally forwardly to bring the same into said
position where said second member is substantially spaced
therefrom, said operating means being a control member pivotally
mounted on said first member for movement about a lateral
transverse axis parallel to the hinge axes of said links, said
second member being connected to said rotatable control member at a
point spaced rearwardly of the axis of rotation of said rotatable
control member when said second member is contiguous to said
passageway dilating portion of said first member so the bars are
separated by pushing on the control member.
17. The dilator device of claim 16 wherein the point of connection
of said second member to said rotatable control member when said
second member is contiguous to said passageway dilating portion of
said first member is on or adjacent to a line extending through the
axis of rotation of said rotatable control member and generally
parallel to the length of the dilator device, whereby the variation
in the spacing of said second member from the passageway dilating
portion of said first member forms a roughly linear function with
the angle of rotation of said rotatable control member.
18. The dilator device of claim 16 wherein said first member
includes a forward extension in front of the forwardmost portion of
said second member, which extension is forwardly tapered and is
relatively flexible for aiding in guiding the dilator device into
and through a constricted passageway.
19. The dilator device of claim 16 wherein said rotatable control
member has calibrated index marks thereon which passes opposite a
portion of said first member and indicates the degree of separation
of said second member relative to the passageway dilating portion
of said first member.
20. A dilator device for dilating constricted passageways in a male
urethra, said device comprising at least two relatively separable
generally parallel bars adapted when brought into contiguous
relation to be passed into a male urethra, handle means at the rear
end of the bars for holding the device, said bars being separable
to bring the same to a maximum spaced apart position where the
urethra is dilated thereby, said device having a forwardly tapering
and laterally curving flexible nose portion in the front of said
relatively separable bars for guiding the device into said male
urethra, said flexible nose portion being a longitudinal extension
on the front end of one of the bars and at the inner end thereof
projects laterally beyond the side of the latter bar confronting
the other bar so the periphery of the tapering nose portion
smoothly merges with the periphery of both of the bars when the
bars are brought into contiguous relation.
21. The dilator device of claim 15 wherein there is a forwardly
tapering nose portion in front of one of said members for guiding
the device into a human male or female urethra, and said members
are sized to enter and dilate a human male and female urethra.
Description
This invention relates to an expandable device having its most
important application in calibrating and dilating male and female
urethra, although it also has application to calibrating and/or
dilating, for example, parts of the vascular system and the
esophagus, bile ducts, rectum and uterine cervix. Urethral dilation
by such a device finds use, for example, in urethral strictures and
spasm, nonspecific urethritis, and other inflammatory diseases of
the urethra to increase lumen size for subsequent passage of
operative instruments, in postoperative stenosis from urethral or
paraurethral surgery and in various congenital anomolies.
In many dilating applications, the patient visits the doctor a
number of times for a progressive dilation of the constricted
passageway involved. During each visit, the doctor first desirably
obtains a measure or calibration of the initial internal
circumference of the passageway (measured in terms of a "French
size"). He then dilates the passageway by inserting a dilating
instrument in the passageway to stretch the same to a desired small
degree. In subsequent visits, this procedure may be repeated to
stretch the passageway a greater amount until the ultimate desired
dilation is achieved. In these medical dilating procedures, it is
of utmost importance that the doctor maintains a close and accurate
control over the degree of dilation to avoid unnecessary injury or
trauma to the passageway.
The calibrating and dilating devices heretofore developed come in a
variety of forms. One form of dilating device comprises a set of
straight or curved solid or hollow metal tapered sounds coming in
various progressively increasing sizes. Such devices are cumbersome
to use and the user has a restricted degree of "feel" to the act of
dilating the passageway. In addition, the use of such tapered
sounds employs dilating forces that are generally those of wedging
the tissue thus causing longitudinal stresses along the direction
of the urethra or other passageway rather than the more desired
radial forces necessary for efficient dilation with a minimum of
tissue trauma. Another form of dilating device is a progressively
expandable device. One such device heretofore developed having
several features utilized in the most preferred form of the
invention includes a pair of separate metal parallel bars with
metal links pivotally connected to the same so the bars can be
moved between contiguous and spaced apart positions by
longitudinally shifting one bar with respect to the other. This
previously developed dilator device is made of a large number of
separate metal parts, such as pins, links and the like, making it
difficult and very expensive to make in very small sizes (like
French size 16) which are necessary for many applications. Also,
the transverse cross-sectional shape of the bars of this device is
such that the bars can readily pinch and catch portions of the wall
of the urethra or other vessel being dilated when the dilator
device is collapsed. Also, the construction thereof requires two
hands to move the bars between contiguous and spaced apart
positions, namely, one hand to grab an organ (such as the male
penis) or part of the device and the other hand to actuate a lever.
Such a construction does not give the operator a fine control and
"feel" of the instrument which is most important in the safe and
effective use thereof.
In accordance with one of the features of the invention, the
problem of making an expandable parallel bar type dilator
economically in very small sizes is overcome by making the
separable bars and the hinged links extending therebetween as a
single integral molded synthetic plastic part with the pivot points
of the links formed by sharply reducing the thickness of the
synthetic plastic material. The cost of the dilator device for even
very small sizes can be thus reduced to a point where the device
can be a one-use disposable unit. The metal expandable devices
heretofore made are very expensive devices, costing in excess of
100 dollars. The present invention can be made to sell for much
less than the cost of cleaning and sterilizing a device (e.g. 1 to
2 dollars) so it becomes a disposable unit. Moreover, the dilator
device of the preferred form of the invention is functionally
superior to the best of the prior expandable devices.
In accordance with another aspect of the invention, the links are
spaced relatively close together to form a cage for holding back
loose tissue which could otherwise be caught between the bars when
the same are collapsed. Moreover, the cross-sectional shape of the
bars, rather than being semicylindrical in shape as in the case of
the prior devices, is of rounded or oval shaped so that the points
at which the bars come together when they are collapsed are located
substantially inwardly of the longitudinal side margins of the
bars, further to minimize the possibility of catching loose tissue
between the bars.
A further and most important feature of the invention is the
provision of a means for moving the parallel separable bars of the
dilator device from relatively contiguous to spaced apart positions
which enables the user easily to closely control the degree to
which the bars are separated and to feel opposition to the
separation thereof. This means most advantageously comprises a
thumb-operated control member requiring only one hand to operate.
The dilator device has a handle which is held in the palm of one
hand with the thumb of the hand engaging the control member which
is preferably pushed by the thumb to separate the bars. The degree
of separation of the bars can form a rough linear function of the
thumb movement if the control member is rotatably mounted on or
attached to one of the bars and the other bar linked thereto is
connected to the rotatable control member at a point behind the
pivot axis thereof and near or along a longitudinal line passing
through the pivot axis when the bars are contiguous. The fact that
the dilator device is operated by the thumb gives the user a fine
sensitivity in feeling the opposition to the separation of the
bars, to prevent over dilation of the organ or vessel involved.
Also, index markings can be placed on the control member which
indicates to the user precisely the distance the bars are
separated. The parallel bars preferably are the only separable
portion of the dilator device and thus provides equal dilation for
the full length thereof. Thus, the user can determine from the
aforesaid index markings the distension of the narrowest portion of
the organ or vessel involved, unlike other devices where different
portions of the dilator device can have different cross-sections or
otherwise provide different degrees of distension. The user of
separable, rigid, parallel bars permits the placement of a separate
non-expandable curved guide nose on the end of one of the bars,
which is of assistance in completing passage into the adult male,
pediatric female and, on occasion, in adult females. The guide nose
is made sufficiently flexible that, unlike the metal guide noses of
prior dilating devices, it can readily follow irregular paths
without damaging the passageway and without substantial tissue
trauma.
It is desirable that the dilating portion of a dilating device have
a minimum circumference with a maximum degree of expansion, so that
it can be used with the smallest of passageways and for a large
range of dilation ranges so one instrument can be used for most
dilation applications. To this end, when the dilation device
includes only two parallel bars, the dilating portion of each of
the bars has a substantially elongated cross-section in a direction
transverse to the direction of relative movement thereof, so the
long dimension thereof is much more than twice the shorter
dimension transverse thereto. When the bars are in their relatively
contiguous positions, they occupy an overall elongated space whose
long axis extends in a direction transverse to the direction of
separation thereof and is at least about 1.5 times as long and
preferably about two or more times its short axis. In such case,
when the bars are moved to a position where their outermost
surfaces are separated a distance approximately equal to their
width, the constricted passageway will be expanded to similar
degrees in all directions.
The above and other features and advantages of the invention will
become more apparent upon making reference to the specification to
follow, the claims and the drawings wherein:
FIG. 1 is a side elevational view of a urethral dilator device
constituting the most preferred form of the present invention, the
device being shown in its fully expanded dilating position;
FIG. 2 is a plan view of the dilator device shown in FIG. 1;
FIG. 3 is a view of the dilator device of FIG. 1 when the same has
been adjusted to its fully collapsed position;
FIG. 4 is a greatly enlarged transverse sectional view of the
dilator device of FIG. 1, taken along section plane 4--4
therein;
FIG. 5 is a transverse sectional view through the dilator device
shown in FIG. 3, taken along section plane 5--5 thereof;
FIG. 6 is a greatly enlarged fragmentary sectional view through the
dilator device shown in FIG. 2, taken along section plane 6--6
therein when the dilator device is in its fully expanded
condition;
FIG. 7 is a greatly enlarged sectional view of the portion of the
dilator device shown in FIG. 6 when the same has been fully
collapsed;
FIG. 8 is a greatly enlarged sectional view through a portion of
the dilator device shown in FIG. 2, taken along section plane 8--8
when the device is in its fully expanded condition;
FIG. 9 is a greatly enlarged sectional view of the portion of the
dilator device shown in FIG. 8 when the same is in a fully
collapsed condition;
FIG. 10 is a greatly enlarged sectional view of the portion of the
dilator device which controls the expansion and collapse thereof
taken along section plane 10--10 in FIG. 3, and shows the manner in
which the device is locked in its collapsed condition;
FIG. 11 is a greatly enlarged sectional view through another
portion of the dilator device which controls the expansion and
collapse thereof, taken along section plane 11--11 in FIG. 2, and
shows the manner in which the control member thereof is rotatably
supported.
FIG. 12 is a fragmentary exploded view, partially broken away, of
the tip of the nose portion of the dilator device shown in FIGS.
1-3 and a filiform attachment to be attached to the tip of the nose
portion of the dilator device; and
FIG. 13 is a fragmentary view, partly broken away, showing the
assembly of the filiform attachment and the tip of the nose portion
of the dilator device.
The most preferred form of the invention shown in the drawings and
identified by reference numeral 2 includes a main elongated member
generally indicated by reference numeral 4 which has at one end
thereof a longitudinally extending handle-forming portion 4a
adapted to be grasped in the palm of a hand, a longitudinally
extending dilator bar-forming intermediate portion 4b merging with
the front end of the handle-forming portion 4a, and a slightly
upwardly curving tapered guide nose portion 4c which is
sufficiently flexible in all lateral directions that it can readily
pass around obstructions and other sharp bends in male and female
urethra. The dilator device further includes a dilator bar 6 which
confronts and extends parallel to the dilator bar-forming portion
4b of the main elongated member 4. The dilator bar 6 and dilator
bar-forming portion 4b of the main elongated member 4 are
interconnected by longitudinally spaced pivoted links 8. The ends
of the links 8 are pivotally connected to the dilator bar 6 and the
dilator bar-forming portion 4b of the main elongated member 4 to
enable the same to be moved between relatively contiguous or
collapsed and maximum spaced apart or expanded positions by the
longitudinal shifting of the bar 6 relative to the main elongated
member 4. In the collapsed condition of the dilator device, the
vertical profile of the device as shown in FIG. 3 is an even
profile where the tapered nose portion 4c merges more or less
smoothly with the dilator bar 6 and the dilator bar-forming portion
4b of the main elongated member 4. When viewing the horizontal
profile of the dilator device (FIG. 2), the nose portion 4c merges
smoothly at all times with the dilator bar 6 and the dilator
bar-forming portion 4b.
In the most advantageous form of the invention, the main elongated
member 4, the dilator bar 6 and the links 8 and the hinged
connections thereto at the ends of the links form a single
integrally molded part, which greatly reduces the cost of
manufacture of the same. An important feature of the dilator device
is that the links 8 are spaced quite closely together so as to form
a cage which inhibits or prevents loose tissue from entering the
space between the dilator bar 6 and the dilator bar-forming portion
4b of the dilator device, so that upon collapse of the dilator
device within a constricted passageway loose tissue will not be
caught and pinched by the dilator device. A further minimizing of
the chance of catching loose tissue is effected by rounding the
side surfaces of the dilator device so that the confronting
surfaces which come together upon collapse of the device are
located inwardly of the side margins of the dilator device. This
feature of the invention will be explained in more detail
hereinafter.
The longitudinal shifting of the dilator bar 6 is most
advantageously achieved by the use of a thumb-operated control
member 10 pivotally supported in the manner to be explained to the
front end portion of the handle-forming portion 4a of the dilator
device. The rear end of the dilator bar 6 is secured to the
thumb-operated control member 10 at a point offset from the pivot
axis 11 (FIG. 11) of the control member so that rotation of the
control member 10 will shift the dilator bar 6 longitudinally
between the position where it is contiguous to the dilator
bar-forming portion 4b of the main elongated member 4 and the
position where it is spaced apart to a maximum degree as shown in
FIG. 1. The rotatable control member 10 could be molded with the
other parts of the dilator device just described. However, it is
most convenient to make this control member 10 as a separate part
which interfits with the other parts of the dilator device in a
manner to be more fully explained hereinafter.
The control member 10 is positioned so that when the user grasps
the handle-forming portion 4a in the palm of his hand, the
periphery of the control member is within easy reach of the thumb
of the user which by pushing on the outer periphery of the control
member forwardly longitudinally shifts the dilator bar 6. For
reasons to be explained, to give a maximum effective control over
the movement of the dilator bar 6 when the dilator device is in its
collapsed condition shown in FIG. 3, the point of connection of the
rear end of the dilator bar 6 to the control member 10 is along or
adjacent a line passing through the pivot axis 11 of the control
member and extending generally parallel to the length of the
dilator device. In such case, when the thumb of the user engages
the periphery of the control member and pushes forwardly thereon,
for each incremental angular rotation of the control member 10 the
dilator bar 6 will move a similar appreciable distance relative to
the dilator bar-forming portion 4b of the main elongated member 4.
(If the user's thumb were to engage the rear end of the dilating
bar directly, the transverse movement of the dilator bar would be a
sinusoidal-like function of the degree of thumb movement rather
than a near linear function thereof, as in the case with the use of
a rotatable control member. The broad aspects of the invention,
however, include the use of a direct operation of the dilator's
bar.
To most conveniently mold the dilator bar 6, the links 8, and the
main elongated member 4 as one integrally molded piece, these parts
are molded with the dilator bar 6 spaced a maximum distance from
the main elongated member 4. In such case, the resiliency of the
synthetic plastic material out of which the device is made (which
is most advantageously polyethylene or nylon) will urge the dilator
device into its maximum expanded condition shown in FIG. 1. The
resilient force which urges the dilator bar 6 to the position is,
however, such a modest force that a constricted urethral or other
passageway will easily force the device into its collapsed
condition. Thus, the force applied by the user's thumb against the
control member 10 will operate against the collapsing force of the
passageway involved so that the user can feel the opposition to the
movement of the control member 10. The control member 10 has
calibrated index marks 9 on the sides thereof which indicate the
circumference in French size number of a passageway dilated by the
device. The French size is identified by the number which is
adjacent to the upper surface of the handle-forming portion 4a of
the main elongated member 4. Thus, in FIG. 1, the French size of
the dilated vessel which is expanded by the dilator device shown in
FIG. 1 will be French size 40.
Now that the general features of the dilator device 2 have been
described, the particular preferred constructional details of the
various parts thereof in the most preferred form of the invention
will be described. Although the shape of the handle-forming portion
4a may vary widely, the vertical profile of the rear end portion 13
thereof to be held in the palm of the hand preferably has the
relatively consistently thin slightly curved shape shown in FIG. 1
and the horizontal profile thereof preferably has the thicker
bulbous profile shown in FIG. 2. When such a handle is properly
grasped in the palm of the user's hand, the user's thumb will be at
the top of the handle-forming portion 4a where it can operate the
control member 10.
The front portion of the handle-forming portion 4a of the main
elongated member 4 is provided with a rectangular elongated
vertical opening 12 extending completely through the handle-forming
portion 4a. The rectangular opening 12 is elongated in the
direction of the length of the dilator device to provide a
convenient opening in which the control member 10 may move during
the operation thereof.
The control member 10 preferably has a circular segmental
peripheral portion 10a with circumferentially spaced ribs 14
forming knurling which is engaged by the thumb of the user in
rotating the control member. The control member has generally flat
sides 10b--10b which, for most of the extent thereof, are spaced
apart a smaller distance than the width of the rectangular opening
12 so it can freely move therein. The index marks 12 may be
embossed on or otherwise placed upon the sides 10b--10b of the
control member 10. At a point adjacent the French size index number
for the fully collapsed condition of the dilator device, the sides
of the control member are thickened at 10c--10c (see FIG. 10) to a
point where the thickness of the control member is somewhat greater
than the width of the rectangular opening 12 so that the control
member will then be wedged in a locked condition within the opening
12.
Projecting laterally outwardly from the sides of the control member
10 are a pair of axially aligned pivot-forming pins 17--17. As best
shown in FIG. 11, on opposite sides of the rectangular opening 12
in the handle-forming portion 4a there are provided a pair of pivot
pin-receiving openings 19--19 which open through inwardly tapering
entryways 20-20 to the top of the handle-forming portion 4a. The
pivot-forming pins 17--17 of the control member 10 snap into place
within the openings 19--19 so the control member 10 is freely
pivotally supported for movement within the rectangular opening 12.
The front end portion of the periphery 10a of the control member 10
most desirably merges with a concave portion 10d which forms a
convenient initial point of contact of the thumb with the control
member when the control member is in its position shown in FIG. 3
where the dilator device is in its fully collapsed condition, as
shown in FIG. 3 in dashed lines. The position of the user's thumb
when the dilator device is in its fully expanded condition is shown
in dashed lines in FIG. 1.
The control member 10 is provided with a segmental cylindrical
opening 21 at a position roughly along a line extending between the
pivot-forming pins 17 and the index marks showing the smallest
French size. This opening 21 slidably receives a protuberant
portion 6a at the rear end of the dilating bar 6.
The cross-sectional shape of the dilator bar 6 and the dilating
bar-forming portion 4b of the main elongated member 4 is most
advantageously like that shown most clearly in FIGS. 4 and 5. The
cross-sectional shape for the dilator bar 6 will now be described,
it being understood that the dilator bar-forming portion 4b has the
identical shape although inverted with respect thereto. The dilator
bar 6 has an outer peripheral surface 6b which falls along a circle
whose center is positioned about midway between the dilator bar 6
and the dilator bar-forming portion 4b of the main elongated member
4 when the dilator bar 6 is spaced a maximum degree from the main
elongated member 4, as shown in FIG. 1. The inner surface 6c of the
dilator bar 6 is a flat surface which interconnects with the
rounded outer peripheral surface 6b through rounded convex surfaces
6d--6d so the ends of the flat surface 6c is positioned inwardly of
the sides of the dilator bar 6 to minimize the possibility of
catching loose tissue when the dilator device is collapsed within a
passageway. The cross-sectional shape of the dilator bar 6 is
elongated horizontally as viewed in FIG. 1, that is in the
direction of the axis of rotation of the control member 10, the
length of the long axis thereof being much more than twice the
short axis so that when the dilating member 6 is brought into
contiguous relation with the dilator bar-forming portion 4b of the
main elongated member 4 the overall cross-sectional profile of the
collapsed dilator device is still an elongated shape with the long
axis at least about 1.5 times and most preferably twice the short
axis of this overall configuration, as best shown in FIG. 5.
Each of the illustrated links 8 is generally square in shape when
viewed in front or rear elevation (i.e. in a plane transverse to
the longitudinal axis of the dilator device) and is very thin when
viewed in side elevation, as shown in FIG. 1. The horizontal width
of each of the links 8 is somewhat less than the corresponding
dimension or width of the dilating bar 6 and the dilator
bar-forming portion 4b of the main elongated member 4. It can thus
be seen that when the dilator device is fully collapsed, the flat
inner surface 6c of the dilator bar 6 and the flat inner surface 25
of the dilator bar-forming portion 4b of the main elongated member
4 respectively make facial contact with the opposite sides of the
various links 8 which then extend generally parallel to the length
of the dilator device (see FIG. 9). These engaging surfaces are
located inwardly of the side margins of the dilator device so the
possibility of loose tissue being pinched by the collapsed dilator
device is minimized.
As best shown in FIG. 8, the hinges at the ends of the links 8 are
provided by a thinning of the synthetic plastic material out of
which the dilator device is made, so that the dilator bar 6 and the
dilator bar-forming portion 4b of the main elongated member 4 are
respectively hingedly supported for movement about horizontal
laterally extending pivot axes as viewed in the drawings.
In the preferred embodiment as illustrated, the forwardmost link 8'
of the dilator device (FIG. 6), unlike the other links 8, is an
initially forwardly curving element whose bottom end joins a
constricted neck 27 of the tapered nose portion 4c and whose upper
end merges with the forward end of the dilator bar 6. As shown in
FIG. 7, when the dilator device is fully collapsed by the rearward
longitudinal shifting of the dilator bar, the curved portion 8' is
flattened so it extends longitudinally and merges smoothly with the
nose portion 4c.
The nose portion 4c of the dilator device tapers from its rear end
to its forward end and is curved slightly upwardly as viewed in
FIG. 1. This curved shape of the nose portion 4c is important in
guiding the instrument through the male urethra. The dilator device
2, however, as illustrated, is also useful for insertion into a
female urethra. It is sometimes necessary to attach a filiform
member to aid in guiding the device through torturous paths in a
diseased male urethra. Such a filiform attachment is illustrated in
FIGS. 13 and 14 and identified by reference numeral 30. To enable
the attachment of the filiform attachment 30 to the end of the nose
portion 4c a longitudinally extending threaded portion 32 is formed
at the tip of the nose portion 4c. As best shown in FIG. 13, the
threaded portion 32 is initially imperfectly threaded so the
threading has a rounded profile wherein no sharp edges are
presented which can scratch or cut the tissue of the urethra or
other passageway involved as the nose and expandable portions of
the dilator device are passed into and through the passageway
involved. The diameter of the threaded portion 32 is substantially
less than the diameter of the adjacent portion of the nose portion
4c so that when the end of the filiform attachment 30 is threaded
around the threaded portion 32, the inner end of the filiform
attachment will merge evenly with the end of the nose portion 4c of
the dilator device.
As illustrated, the rear end of the filiform attachment 30 has a
metal socket-forming member 34 attached to the main body of the
filiform attachment which is made of a flexible synthetic plastic
material such as polyethylene. The threaded portion 32 of the
dilator device is made slightly oversized so that the threaded
metal socket-forming portion 34 of the filiform attachment 30 will
cut and sharpen or merely deform the margins of the threaded
portion 32 to form a perfect thread when applied thereto, so the
filiform attachment will be securely attached to the threaded
portion 32.
It is apparent that the present invention provides a very
inexpensive instrument for calibrating and dilating various human
and animal passageways with safety and with a very fine degree of
control.
It should be understood that numerous modifications may be made in
the most preferred form of the invention described without
deviating from the broader aspects of the invention.
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