U.S. patent number 3,884,220 [Application Number 05/399,424] was granted by the patent office on 1975-05-20 for method for injecting x-ray contrast media for venography of the female pelvis.
Invention is credited to Leo J. Hartnett.
United States Patent |
3,884,220 |
Hartnett |
May 20, 1975 |
Method for injecting X-ray contrast media for venography of the
female pelvis
Abstract
A method for injecting x-ray contrast media into the wall of the
uterus a predetermined depth to make a record of the venous plexus
system of the uterus. A straight rod probing member having a
probing surface for probing against the uterine wall is inserted
into the uterus and a piercing member arranged to be combined with
a syringe is slidably disposed in the probing member and extended a
predetermined amount from the probing surface when the probing
surface contacts the uterine wall. X-ray opaque material is then
injected into the spongy layer of the uterus and an X-ray record
made of the passage of said opaque material through the venous
plexus system.
Inventors: |
Hartnett; Leo J. (St. Louis,
MO) |
Family
ID: |
26953466 |
Appl.
No.: |
05/399,424 |
Filed: |
September 21, 1973 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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269038 |
Jul 5, 1972 |
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Current U.S.
Class: |
600/431; 604/117;
604/164.01 |
Current CPC
Class: |
A61M
5/007 (20130101); A61M 25/0069 (20130101); A61M
31/00 (20130101) |
Current International
Class: |
A61M
25/00 (20060101); A61M 31/00 (20060101); A61M
5/00 (20060101); A61b 006/00 () |
Field of
Search: |
;128/2A,2R,2B,215,216,221,347,245,260 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Howell; Kyle L.
Attorney, Agent or Firm: Pope, III; John D.
Parent Case Text
This is a continuation of application Ser. No. 269,038, filed July
5, 1972, now abandoned.
Claims
What is claimed is:
1. The method of making a record of the venous plexus system of a
uterus which comprises inserting into the uterus a tubular shaped
instrument having a hollow core and a rounded probing end, probing
with the instrument to locate the fundus with the rounded end,
inserting a hollow needle having a piercing point and an opening
through the center of said needle into the hollow core of the
tubular instrument to penetrate the surface of the fundus,
restraining the needle so that said penetration occurs only to a
predetermined depth into but not through the wall of the uterus,
injecting x-ray opaque material into the opening in the needle so
that it passes through the needle into the spongy layer of said
uterus and then exposing an x-ray film to record the passage of
said x-ray opaque material through the venous plexus system of the
uterus on the x-ray film.
2. The method according to claim 1 in which a plurality of x-ray
film pictures are taken at different times subsequent to the
injection of the x-ray opaque material.
3. The method of claim 1 in which restraint of the needle is
accomplished by limiting the extent to which the needle can project
from the end of the tubular instrument.
4. The method of claim 3 in which the passage through the tubular
instrument is plugged while penetrating the fundus but the plug is
thereafter removed and x-ray opaque material injected through the
passage.
5. The method of claim 4 in which the needle is locked in position
when it reaches its predetermined projecting position.
6. The method of claim 2 in which the time interval between the
first and second picture is approximately 10-15 seconds.
Description
This invention is directed to new and useful method for supplying
x-ray contrast media to blood vessels in the uterus.
In making an x-ray examination of the uterus and the venous
vascular system therein it is known to make an incision in the
abdomen and to pass a needle containing the contrast medium, such
as Vascoray or Conray 30 manufactured by Mallinckrodt Chemical
Works, through the incision directly into the uterine wall. Such a
procedure involves the risk that the x-ray contrast media will not
be entirely localized in the uterus since the needle that injects
the contrast media can have insufficient or excess penetration.
There is also a danger that the needle will accidentally penetrate
and injure the intestine or other vital organ of the body
surrounding the uterine wall.
Among the several objects of the present invention may be noted the
provision of a novel method of probing and penetrating method for
supplying x-ray contrast media to the uterine wall; a novel method
for supplying x-ray contrast media to the uterus by direct
insertion of a device through the vaginal opening; a novel probing
and penetrating method for supplying fluid to a body surface within
a body cavity at a predetermined depth from the body surface, a
novel probing and penetrating method for supplying x-ray contrast
media to the uterus at a predetermined location therein; and a
novel probing and penetrating method for locating a wall portion of
an internal body cavity and penetrating the located wall portion a
predetermined depth. Other objects and features will be in part
apparent and in part pointed out hereinafter.
The present invention relates to a novel intrauterine method for
probing the uterus to locate a desired portion of the uterine wall
and for injecting a supply of x-ray contrast media a predetermined
depth in the uterine wall.
In one embodiment the intrauterine device used in the method
comprises an elongated probe member having a probing surface at one
end thereof and a piercing member extensible a predetermined amount
from the probing surface. The piercing member penetrates the
uterine wall to a predetermined depth measured by the extension of
the piercing member from the probing surface. The piercing member
is combined with a syringe to inject the x-ray contrast media into
the uterine wall. In another embodiment the length of the piercing
member can be varied.
The invention accordingly comprises the method hereinafter
described, the scope of the invention being indicated in the
following claims.
In the accompanying drawings, in which several of various possible
embodiments of apparatus for carrying out the method of the
invention are illustrated,
FIG. 1 is a perspective view of the unassembled members of an
intrauterine device incorporating one embodiment of my
invention;
FIG. 2 is an enlarged fragmentary plan view showing the members of
the intrauterine device in an assembled condition;
FIG. 3 is a sectional view taken along the line 3--3 of FIG. 2;
FIG. 4 is a sectional view taken along the line 4--4 of FIG. 2;
FIG. 5 is a sectional view taken along the line 5--5 of FIG. 2 and
further illustrates a fragmentary section of a uterine wall;
FIG. 6 is a modification of the intrauterine device of FIGS.
1-5.
Corresponding reference characters indicate corresponding parts
throughout the several views of the drawings.
Referring now to the drawings for a detailed description of the
apparatus for carrying out the present invention, and intrauterine
device incorporating one embodiment thereof is generally indicated
at 10. Intrauterine device 10 comprises a probing member 12, a
piercing member 14 insertable in probing member 12, and a stylet
member 16 insertable in piercing member 14.
Probing member 12 is formed of any suitable inert material such as
monel metal or plastic and comprises an elongated hollow rod 18
having a bulb shaped end portion 20. Bulb end portion 20 includes a
hollow threaded bushing 21 arranged to bear against an O-ring 23
made of any suitable material. Bushing 21 conforms to the contour
of bulb end portion 20, and includes spaced holes 25 formed
therein. A pair of oppositely disposed handle rings 22, 22 are a
fixed to rod 18 near an end portion 24 thereof. Probing member 12
is also provided with a longitudinal bore 26 extending through rod
18 from end portion 20 to end portion 24. End portion 24 of rod 18
includes a cup-shaped counter bore 28 communicating with
longitudinal bore 26. Probing member 12 can be entirely molded in
one piece or the component parts thereof such as rod 18, rings 22,
22 and bulb end portion 20 can be separately manufactured and
assembled in any suitable known manner.
Piercing member 14 is formed of any suitable material such as
stainless steel and comprises an elongated tube 30 having one end
32 secured to a first support member 34 and an opposite end 36
tapered to a point. The hollow portion of tube 30 is designated 38.
First support member 34 has a hollow portion 40 communicating with
hollow portion 38 of tube 30 and also includes an engaging portion
42 complementary in shape to cup-shaped counter bore 28 of rod 18.
First support member 34 further includes an adapter portion 44
engageable with any suitable known syringe (not shown). Adapter
portion 44 includes a flange 46 having a key slot 48 provided
therein. A cup-shaped counter bore 49 at flange 46 communicates
with hollow portion 40 of first support member 34.
Stylet member 16 is formed of any suitable material such as
stainless steel and comprises an elongated wire 50 having one end
52 secured to a second support member 54. An opposite end 56 of
second support member 54 is tapered to a point, the taper angle of
end 56 corresponding to the taper angle of end 36 of tube 30.
Second support member 54 also includes an engaging portion 58
complementary in shape to cup-shaped counter bore 49 of first
support member 34. A flange 60 formed around the periphery of
engaging portion 58 is provided with a depending key projection
62.
In using intrauterine device 10 bulb end portion 20 of probing
member 12 is inserted through the vaginal opening into the uterus.
Probing member 12 is manipulated at handle rings 22, 22 such that
bulb end portion 20 probes against a portion of the uterine wall
such as a fundus 64, which fundus is shown in fragmentary section
in FIG. 5.
It is desirable to control the depth of penetration of tube 30 into
fundus 64 to ensure that tube 30 does not pass entirely through
fundus 64 and out of the uterus. It is also desirable to obtain
sufficient penetration of tube 30 into fundus 64 to ensure that the
injected x-ray contrast media will be forced into the uterine
circulatory system.
I have found that the uterine wall is generally 2-3 centimeters
thick and comprises spaced outer layers of muscular tissue
sandwiching an inner layer of spongy tissue. The spongy inner layer
contains blood vessels or venous plexus and lies at least 1/4
centimeter beneath the endometrium. The uterine muscular tissue
strongly resists injection of any liquid therein whereas the spongy
layer containing the plexus provides minimal resistance to
injection of liquid therein. X-ray contrast media injected into the
plexus tends to follow the drainage current of the venous system or
blood circulation network mixing with the blood such that the
venous vascular system shows up on the x-ray film. It is thus
advantageous to inject the x-ray contrast media to a depth below
the endometrium, that is within the spongy layer of tissue.
Stylet end 56 is placed in counter bore 49 of first support member
34 and wire 50 is inserted into hollow portion 38 of piercing tube
30 until engaging portion 58 engages counter bore 49. The diameter
of wire 50 is sized to form a slip fit into hollow portions 38 and
40 of tube 30 and first support member 34, respectively. When
engaging portion 58 is nested in counter bore 49, second support
member 54 is rotated to a position wherein key projection 62
engages key slot 48. thereby aligning tapered ends 36 and 56 of
tube 30 and wire 50 as shown in FIG. 5. Tapered end 56 of wire 50
thus plugs hollow portion 38 of tube end 36. The length of wire 50
necessary to plug tube end 36 can be determined by measuring the
distance from counter bore 49 to tube end 36 when stylet member 16
is inserted in piercing member 14 such that engaging portion 42
nests in counter bore 49 and key projection 62 is aligned in key
slot 48. This measurement would also include allowance for
attachment of wire 50 to second support member 54.
The sub-assembly of stylet member 16 and piercing member 14 is next
assembled to the vaginally disposed probing member 12 by inserting
tapered ends 36 and 56 of tube 30 and wire 50 into bore 26 at end
24 of rod 18. The diameter of bore 26 is sized to permit slidable
insertion of tube 30 therein.
Insertion of piercing member 14 and stylet member 16 in probing
member 12 is limited by the engagement of engaging portion 42 with
counter bore 28. This engagement defines an insertion limit
position of tube 30 in probing member 12.
To control the depth of penetration of piercing tube 30 into fundus
64 piercing tube 30 is fashioned to a predetermined length such
that when piercing tube 30 is in its insertion limit position
tapered end 36 will project approximately 1/3 centimeter beyond
bulb end portion 20. The length of tube 30 necessary to enable tube
end 36 to project 1/3 centimeter beyond bulb end portion 20 when
piercing member 14 is in its insertion limit position can be
determined by measuring the distance from counter bore 28 to bulb
end portion 20 and making allowance for the 1/3 centimeter
penetration depth plus the amount of tube length needed to affix
tube 30 to first support member 34. In this manner the depth of
penetration of tube 30 in fundus 64 is predetermined and thereby
controlled.
With piercing member 14 disposed in probing member 12 at the
insertion limit position, tapered end 36 of tube 30 extends beyond
bulb end portion 20 the desired predetermined amount. Tapered end
56 of wire 50 prevents any body material from entering tube end 36.
Since bulb end portion 20 of probing member 12 has been positioned
against fundus 64 tapered end 36 of probing member 12 penetrates
fundus 64 to the desired predetermined depth. Stylet 16 is then
withdrawn from piercing member 14 and any suitable known syringe
(not shown) containing x-ray contrast media is connected to first
support member 34 at adapter portion 44. X-ray contrast medial
supplied by the syringe is thus injected into fundus 64 a
predetermined depth. I have found that when tapered end 36 faces
the left as shown in FIG. 5 the direction of flow of x-ray contrast
media within fundus 64 is to the left. The reverse would be true
when tapered end 36 faces the right. Thus by providing a guidemark
35 on first support member 34 as shown in FIG. 2 to indicate the
direction that tapered end 36 in facing, one can control the
direction of flow of x-ray contrast media in the blood stream of
the venous plexus.
Bulb end portion 20 in addition to serving as a probing surface to
locate fundus 64 or other portions of the uterine wall also
functions as a tampon during injection of x-ray contrast media into
the venus plexus. Bulb end portion 20 thus helps keep the x-ray
contrast media from leaking out of the penetrated uterine wall area
whereas the blood circulation system in the fundus receives the
injected x-ray contrast media which is forced into the penetrated
area of the vascular plexus mixing with the blood within the
vessels and being carried along allowing the outline of this stream
to be visualized by x-ray thus demonstrating the vascular system
within the uterus and its adnaxal apendeges as well. Bushing 21 and
O-ring 23 cooperate to form a seal against tube 30 thereby
preventing any body fluid or x-ray contrast media from flowing into
rod 18. Any suitable wrench (not shown) having pins engageable with
holes 25 can be used to adjust or remove bushing 21 from bulb end
portion 20.
Probing member 12 can be tilted or otherwise manipulated in the
uterus to cause bulb end portion 20 to probe against varying
locations on the uterine wall for injection of x-ray contrast
media. An x-ray picture can be taken during injection of the
contrast media and such picture will provide definitive constrasts
representing the venous vascular system. Another x-ray picture can
be taken within 10 to 15 seconds after injection of the x-ray
contrast media is completed.
Although the depth of penetration of piercing tube 30 is fixed for
a particular combination of piercing member 14 and probing member
12 different predetermined depths of penetration can be achieved by
combining other probing members similar to probing member 12 but of
varying lengths, with a fixed length piercing tube 30 or vice
versa.
A modification of device 10 as shown in FIG. 6 and generally
designated 130 permits adjustable variation of the depth of
penetration of tapered end 36 in a uterine wall. Device 130
comprises a piercing member 132 having a first support member 134
that includes an adapter portion 136, a flange 138, and a
cup-shaped counter bore 140, respectively identical to adapter
portion 44, flange 46 and bore 49 of device 10. First support
member 134 further includes a reduced neck portion 142 having
graduations 144 inscribed thereon and a hollow portion 150
extending through neck 142 to bore 140. A tube 152 is affixed to
neck 142 at a tube end portion 154. Tube 152 is partially threaded
at 156, the remaining portion of tube 152 being unthreaded and
identical in structure to tube 30 of device 10.
Device 130 further comprises a probing member 158 comprising a rod
160 having a free end portion 162. Free end portion 162 includes a
bore 164 and an internally threaded bushing 166 pressed into bore
164. Rod 160 includes a knurled lock screw 168, threaded therein
below bushing 166. The remaining portion of probing member 158 is
identical to probing member 12. Stylet member 16 although not shown
is incorporated into device 130.
Device 130 is used in the same general manner as device 10. The
depth of penetration of tapered end portion 36 of tube 152 can be
varied a predetermined amount by rotating first support member 134
in probing member 158 such that threads 156 of tube 152 engage
threaded bushing 166. The projection of tapered end portion 36 from
bulb end portion 20 is measured by reading the position of free end
162 with respect to graduations 144 on neck 142 of first support
member 134. Since the muscular layer of the uterus is substantially
more resistant to injection of liquid than the spongy layer, the
spongy layer can be located by varying the projection of tapered
end 36 from bulb end portion 20 to extend beyond the muscular layer
and then into the spongy vascular layer. When tapered end 56 is
projected an amount that permits injection of liquid into the
uterine wall with minimal resistance the spongy layer has been
located. Knurled screw 168 is then tightened to lock piercing tube
152 into its desired position during full injection of x-ray
contrast media into the vascular system of the uterus.
As will be apparent to those skilled in the art the intrauterine
device can be adapted for use in probing other internal bodily
cavities besides the uterus and penetrating the wall structure of
these cavities to a predetermined depth. Although the uterus forms
an angle of approximately 100 to 110 degrees with the vagina, it is
normally quite movable and will easily accomodate devices 10, and
130. Devices 10. and 130 can be manufactured as an entirely
reusable or disposable item or, if desired, some of the component
parts thereof such as piercing members 14, 132 and stylets 16, 76,
can be made in reusable form with probing members 12, 158 fashioned
as a disposable item.
Some advantages of the novel intrauterine device evident from the
foregoing description include a device that can probe a uterine
wall to locate a desired portion thereof, and a device that can
inject fluid into a uterine wall to a predetermined depth. Other
advantages include a vaginally insertable device for injecting
x-ray contrast media into the uterus thereby obviating the
procedure of making abdominal incisions. Further advantages include
a device that is relatively simple and safe to use regardless of
the health of bodily structure adjacent the uterus. Safety arises
from the fact that the depth of penetration of piercing tubes 30,
and 152 is controlled to substantially eliminate any risk of
penetrating bodily structures outside the uterine wall. Still
another advantage is a device that can inject x-ray contrast media
directly into the uterus to provide x-ray visualization of the
venous vascular system with success that approaches a
certainty.
In view of the above, it will be seen that the several objects of
the invention are achieved and other advantageous results
attained.
As various changes could be made in the above constructions without
departing from the scope of the invention, it is intended that all
matter contained in the above description or shown in the
accompanying drawings shall be interpreted as illustrative and not
in a limiting sense.
* * * * *