Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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S~r~ARY OF THE INVENTION:
The invention is directed to an apparatus for dispensing
a material, as a drug, into the canals of the Fallopian tubes.
The apparatus has a housing having a chamber. Container means
storing the material is located in the chamber. ~ieans having
a passage for receiving the material from the container means
is associated with the housing. r~eans, as a needle, is operable
to puncture a part of the container means whereby material
from the container means passes to the passage and the means
for receiving the fluid. Actuator means cooperate with the
container means and means for piercing the container means
whereby material within the container means flows from the
container means into the passage for receiving material.
One form of the container means has a collapsible side
wall surrounding a chamber for storing one unit of fluid. The
needle is located within the chamber whereby the container
means material and needle are a compact assembly with the
needle protected by the container means. The bottom wall of
the container means has a tubular member closed with a diaphragm.
The needle pierces the diaphragm when the container means is
collapsed whereby the material is dispensed from the container.
One form of the apparatus has a body with a pair of
chambers and an elongated first tube adapted to be inserted
into the uterine caavity. A second tube within the first tube
is connected to one of the chambers. An expandable sleeve
attached to the end of the first tube fills the uterine cavity.
Fluid, as water or air, under pressure within the sleeve holds
the sleeve in firm engagement with the inner wall of the uterus.
Containers storing materials are located in the chambers. An
actuator mechanism cooperates with the containers to sequent-
ially dispense the materials into the first tuhe to expand the
sleeve and then into the second tube to discharge material, as
a drug, tissue adhesive, or the like, into the uterine cavity.
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More specifically, the invention is directed to a methodand apparatus for introducing a predetermined amount of tissue
adhesive into the canals of the Fallopian tubes of a female
from the uterine cavity. The apparatus has an elongated probe
having a forward end carrying an expandable balloon assemhly.
A dispensing housing having an actuator is used to expand the
balloon assembly and discharge material into the uterine cavity.
The dispenser has a first drive assembly operable to initially
partially expand the balloon assembly to form a seal and hold-
ing structure in the lower portion of the uterine cavity.Continued movement of the actuator discharges the material into
the uterine cavity above the partially expanded balloon assembly.
Further continued movement of the actuator continues the expan-
sion of the balloon assembly to displace the remaining space
in the uterine cavity. The balloon assembly expands and forces
the material into both canals of the Fallopian tubes. Substan-
tially all of the material introduced into the uterine cavity
is moved by the expanding balloon assembly into the canals of
the Fallopian tubes in a short period of tiem. When a tissue
adhesive is placed in the canals, it reacts with the tissue
to polymerize the adhesive and thereby occlude the canals.
The tissue adhesive is eventually replaced with scar tissue
which permanently occludes the canals. The balloon assembly
is contracted whereby it can be readily removed from the uterine
cavity by withdrawing the actuator from the housing.
The material can be a mixture of materials which set up
after they are mixed. Separate materials are moved to the
discharge end of the dispenser and mixed at the end. The mix-
ture of materials is directed into the uterine cavity. The
expansion of the balloon assembly forces the mixture of
material into the canals of the Fallopian tubes.
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The invention includes the method of occluding the canals
of the Fallopian tubes by inserting an instrument having an
expandable sleeve into the uterine cavity through the cervical
opening. The expandable sleeve is subjected to fluid under
pressure to hold the sleeve in firm uniform engagement with
the inner wall of the uterus. A fluid, as a drug, tissue
adhesive or the like, is delivered via the instrument to the
upper section of the uterine caivty. The fluid flows over the
top of the expanded sleeve and into the canals of the Fallopian
tubes. Tissue adhesive fluids react with the moisture in the
tissue of the Fallopian tubes to set up the adhesive, thereby
blocking the canals. Other types of fluids can be injected
into the canals to kill the tissue of the canal linings. This
tissue is replaced with scar tissue which occludes the canals.
The instrument is removed from the uterine cavity after the
sleeve is deflated by draining the fluid therefrom.
An object of the invention is to provide an apparatus and
method of introducing a predetermined minimum amount of material
into both canals of the Fallopian tubes of a female from the
uterine cavity. Another object of the invention is to provide
a dispensing apparatus and method which has an actuator movable
to discharge tissue adhesives into the uterine cavity and move
the tissue adhesives from the uterine cavity into the canals
of the Fallopian tubes of a female before the adhesives can
set up in the uterine cavity. Another object of the invention
is to provide an apparatus for introducing in a short period
of time a controlled amount of material into the canals of the
Fallopian tubes under low pressure with a single and continuous
action on the part of the operator. A further object of the
invention is to provide an apparatus for introducing material
into the canals of the Fallopian tubes which places a minimum
amount of force on the walls of the uterus and can accommodate
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different sizes, shapes and characteristics of uteri. A
further object of the invention is to provide an apparatus
and method for introducing material into both canals of the
Fallopian tubes which is not position sensitive and does not
apply substantial pressure to the material, whereby the material
is not forced into the blood stream or body cavity. Yet an-
other object of the invention is to provide an apparatus and
method of introducing material into both canals of the Fallopian
tubes with the balloon assembly subjected to a maximum predeter-
mined pressure to eliminate over-expansion of the uterus. A
still further object of the invention is to provide an apparatus
for placing material into the canals of the Fallopian tubes
which is simple to operate and is used with a minimum of mani-
pulative delay. Another object of the invention is to provide
an apparatus and method for mixing separate materials, directing
the mixed materials into the uterine cavity and forcing the
mixed materials in the uterine cavity into the canals of the
Fallopian tubes. Other objects and advantages of the apparatus
and method of the invention are set out in the following speci-
fication and accompanying drawings.IN THE DRAWINGS:
Figure 1 is a longitudinal sectional view of the genital
system of a female primate with the dispensing instrument
extended into the uterine cavity;
Figure 2 is a top elevational view of the dispensing
unit of the instrument;
Figure 3 is an enlarged sectional view taken along the
line 3-3 of Figure l;
Figure 4 is an enlarged sectional view taken along the
line 4-4 of Figure 3;
Figure 5 is a sectional view taken along the line 5-5
of Figure 4;
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Figure 6 is a sectional view similar to Figure 4 showing
the dispensing unit actuated to discharge fluid therefrom;
Figure 7 is a cross sectional view o-f a modified dispen-
sing unit for the dispenser;
Figure 8 is a sectional view taken along the line 8-8
of Figure 7;
Figure 9 is a sectional view similar to Figure 7 showing
the dispensing unit in the discharge position;
Figure 10 is a diagrammatic view of a further modification
of the dispensing unit in a non-dispensing position;
: Figure 11 is a sectional view similar to Figure 10 showing
the dispensing unit in the discharge position;
Figure 12 is a longitudinal sectional view of a further
modified dispensing unit in the non-dispensing position;
Figure 13 is a view similar to Figure 12 showing the
dispensing unit in the discharge position;
Figure 14 is a side elevational view of a container spaced
from a needle adapted to carry fluid from the container;
Figure 15 is an end elevational view of the sealed end
of the container of Figure 14;
Figure 16 is a longitudinal sectional view taken along
the line 16-16 of Figure 15;
Figure 17 is an enlarged sectional view of the sealed
end of the container;
Figure 18 is a sectional view taken along the line 18-18
of Figure 14;
Figure 19 is a sectional view similar to Figure 16 showing
the container in assembled relation with the needle;
Figure 20 is a top plan view of a modified dispensing
instrument of the invention;
Figure 21 is an enlarged sectional view taken along the
line 21-21 of Figure 20;
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Figure 22 is a sectional view taken along the line 22-22
of Figure 21;
Figure 23 is an enlarged sectional view taken along the
line 23-23 of Figure 20;
Figure 24 is a sectional view similar to Figure 23 shol~ing
the lock in the release position;
Figure 25 is a sectional view similar to Figure 23 showing
a modification of the lock;
Figure 26 is a top plan view of another modification of
the dispensing instrument of the invention;
Figure 27 is an enlarged sectional view taken along the
line 27-27 of Figure 26;
Figure 28 is a sectional view taken along the line 28-28
of Figure 27;
Figure 29 is an enlarged sectional view taken along the
line 29-29 of Figure 27;
Figure 30 is a view similar to Figure 29 showing the
movable member in the second position;
Figure 31 is an enlarged sectional view of the fluid
container assembly used in the dispensing instrument;
Figure 32 is a foreshortened sectional view o a repro-
ductive system of a female accommodating a dispensing instrument
of the invention for locating drug material in both canals of
the Fallopian tubes;
Figure 33 is a longitudinal sectional view of the dispen-
sing assembly of the instrument of the invention;
Figure 34 is a sectional view taken along the line 34-34
of Figure 32;
Figure 35 is a foreshortened sectional view of the female
reproductive system accommodating the dispensing instrument
shown in section with the balloon assembly partially inflated
in the uterine cavity and drug material in the uterine cavity;
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Figure 36 is a foreshortened sectional view similar to
Figure 35 showing the balloon assembly fully expanded in the
uterine cavity;
Figure 37 is a foreshortened plan view, partly sectioned,
similar to Figure 35, of a modification of the dispensing
instrument; and
Figure 38 is an enlarged sectional view of the discharge
end of the dispensing instrument of Figure 37.
DESCRIPTION OF PREFERRED E~BODIMENTS:
Referring to the drawing, there is shown in Figure 1 a
- diagrammatic female genital system indicated generally at 20.
An intrauterine catheter indicated generally at 21 is located
in the genital system to direct a fluid9 as a drug, tissue
adhesive, or other material, into the canals of the Fallopian
tubes. The tissue adhesive can be isobutyl 2-cyanoacrylate
monomer, silver nitrate or quinacrine materials. The cyano-
acrylate monomer is a liquid plastic which sets up or polymer-
izes in response to moisture and thereby functions to occlude
the canals of the Fallopian tubes. The drug materials can be
of the type that temporarily block or occlude the canals of
the Fallopian tubes. After a period of time the canals will
reopen to resume their normal function.
The genital system 20 has an elongated vagina 22 defined
by the cylindrical vaginal wall 23. The vagina 22 opens into
the vestibule 24. The opposite end of the vagina is attached
to the uterus, indicated generally at 26. Uterus 26 is a pear-
shaped, thick walled, hollow organ situated between the bladder
and rectum. Uterus 26 has a uterine cavity 27 which is flat-
tened and triangular in shape. The size of the uterine cavity
varies from female to female. The top or fundus 28 of uterus
26 is joined to the uterus body 29. The lower end of the body
contains the cervix 31 which separates the vagina 22 from the
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uterine cavity 27. The uterine wall is composed of an outer
serosal layer, or peritoneum; a firm, thick, intermediate coat
of smooth muscle tissue, or myometrium; and an inner mucosal
lining, or endometrium 32.
Leading to the upper part of opposite sides of the uterus
26 are Fallopian tubes 33 and 34. The Fallopian tubes are
paired, trumpet-shaped, muscular members which extend from the
superior angles of the uterine cavity to the ovaries (not shown).
The ovaries are solid, slightly irregular shaped bodies situ-
uated on either side of the uterus behind and below the Fallopiantubes.
Fallopian tubes 33 and 34 each have a canal or aqueduct
36 and 37 respectively. The Fallopian tubes are musculomem-
branous structures about 12 cm. in length. The are commonly
divided into isthmus, intramural and ampullary sections. The
canals 36 and 37 provide passages for the movement of ova from
the ovaries into the uterine cavity. The intramural section
- of the Fallopian tubes traverses the uterine wall in more or
less straight fashion. It has an ampulla-like dilation just
before it communicates with the uterine cavity 27. The canals
36 and 37 are narrowest at the intramural sections. The walls
of the Fallopian tubes consist of three layers; a serosal layer,
a muscular layer and a mucosal lining. The muscular layer
includes longitudinal muscle fibers which, when contracted,
bring the ends of the Fallopian tubes in close contact with
the surface of the ovaries. Blood vessels are abundant in
the muscular layer where they form with the muscle bundles
a kind of erectile tissue which, if engorged, moves the
Fallopian tubes to sweep over the surface of the ovaries.
This movement of the Fallopian tubes is impaired when the
tubes are severed and tied. Occluding the canals 36 and 37
with the drug material according to the invention does not
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interfere with the erectile action and movement of the Fallop-
ian tubes.
Catheter 21 has an elongated first tube 38 having a
length sufficient to extend through the vagina and into the
uterine cavity 27. An expandable sleeve member 39, as a
balloon or the like, is secured to the upper end of tube 38
with bands 40. The outer end of sleeve member 39 terminates
at the outer end of tube 38. Sleeve member 39 is a flexible
elastic member made of relaxed rubber material. The rubber
material has uniform surface tension and uniform expansion
characteristics. Sleeve member 39 is expanded into uniform
and firm engagement with the inner wall o-f the uterus regard-
less of the size of the uterine cavity. This enables the same
catheter construction to be used on all types of primate
females. Expanded sleeve member 39 has a generally pear-shaped
chamber 41 filled with fluid, as water, air or the like. The
tube 38 has a plurality of holes 42 connecting the passage of
tube 38 with chamber 41. The upper end of tube 39 is closed
with a plug 43.
The end of tube 38, projected from the vestibule 24, is
attached to a fluid dispensing unit indicated generally at 44.
Tube 38 can be releasably attached to dispensing unit 44 or
fixed to dispensing unit 44. The dispensing unit has a body
46 carrying a movable plunger 47. When plunger 47 is moved
in the direction of arrow 48, a fluid, preferably water, is
forced from the dispensing unit 44 into the expandable sleeve
member 39 to form a closure and fill the uterine cavity 27.
Located within the tube 38 are a pair of smaller tubes
49 and 52 for carrying fluids into the uterine cavity 27.
Tube 49 has a portion extended outwardly from the tube 38 and
attached to a dispensing unit 51. Tube 52 is attached to a
dispensing unit 53. Dispensing units 51 and 53 are identical
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in construction and can be used to dispense the same fluids
or different fluids at separate time intervals. One of the
dispensing units can dispense a neutralizer fluid into the
uterine cavity. The following description is limited to dis-
pensing unit 51.
Referring to Figures 2 to 5, dispensing unit 51 has a
body or housing 57 comprising a cylindrical side wall 58 and
an end wall 59. Housing 57 has a chamber 61 and outwardly
directed ears 62 and 63. Ears 62 and 63 extend in diametric-
ally opposite directions from opposite sides of the open endof body 57 and cylindrical side wall 58. A collapsible con-
tainer or ampulla indicated generally at 64 is located in
chamber 61. The container holds a drug or similar material
; used in the treatment and/or occlusion of the canals of the
- Fallopian tubes. The container 64 has an accordion cylind-
rical side wall 66 secured to a transverse generally flat
bottom wall 67. The center portion of bottom wall 67 has
longitudinal tubular member 68. Member 68 has an outwardly
projected portion 68A and an inwardly directed portion 68B.
The tubular member 68 is closed with a transverse diaphragm
69. Diaphragm 69 is a relatively thin disc member located
in the transverse plane of bottom wall 67. The opposite end
of the container 64 is closed with a transverse seal 71.
Container 64 is preferably made of a deformable lead
alloy having good moisture and vapor barrier properties.
Other deformable material having good moisture and vapor
barrier properties can be used to fabricate the container.
These properties are important to prevent moisture and vapor
sensitive material from polymerizing or setting up during
storage periods. The material of the container is also chem-
ically inert to the fluid stored in the container.
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Located within the container 64 is a longitudinal needle
73. Needle 73 is a hollow member terminating in an inclined
end having a point 74 located adjacent the inside of diaphragm
69. The opposite end of needle 73 is attached to a circular
head 76. As shown in Figures 4 and 5, needle 73 has a longi-
tudinal passage 77 extended through the pointed end of the
needle.The side wall of needle 73 has a hole 78 to provide
for the flow of liquid form the container through the needle.
Needle 73 can have a plurality of holes or an elongated slot
to provide for the flow of fluid through the needle.
The chamber 61 is closed with a plunger or movable member
79. A portion of the movable member fits into the chamber
and has outwardly directed ribs 81 and 82 extended into longi-
tudinal grooves 83 and 84 in the inside portions of the cylin-
drical side wall 58. The ribs 81 and 82 hold the plunger 79
in assembled relation with the body and guide the body linearly
into the chamber 61. Plunger 79 has in inwardly open recess
- 86 for accommodating the outer end of container 64. The bottom
central portion of recess 86 has a cavity 87 providing a space
for the sealed top 71. Plunger 79 can be removed from the side,
wall 58, enabling the container 64 to be removed from the
chamber and replaced with a new container.
Referring to Figure 6, the dispensing unit 51 is operated
by moving the plunger 79 into the chamber 61. This is accom-
plished by applying a force on the outer end of plunger 79
in the direction of arrow 88. The first and second fingers
are placed under the ears 62 and 63. The thumb is used to
apply force to the plunger 79. The needle 73 will be moved
through the diaphragm 69. The fluid within container 64 will
be placed under pressure and forced through the hole 78 along
passage 77 and into the tube 49. The tube 49 carries the fluid
up into uterine cavity 27. The fluid is discharged from the
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end 54 and flows along the inner wall of the f~mdus into the
canals 36 and 37 of the Fallopian tubes. Pressure is applied
to plunger 79 until all of the fluid in the container 64 is
dispensed therefrom. The sleeve member 39, being in engagement
with the inner wall of the fundus, limits the amount of fluid
that can collect on the inner wall.
The dispensing unit 51 is a disposable item that contains
a single dosage or unit of a drug or fluid. The dispensing
unit can be used as part of a syringe to inject drugs into a
body. The tube 49 can be replaced with a tubular needle which
is placed on the outwardly directed tubular member 68. Tubular
member 68 can contain threads to releasably hold the needle.
Member 68 can be releasably or permanently attached to an
elongated delivery tube.
Referring to Figures 7, 8 and 9, there is shown a modi-
fication of the dispensing unit, indicated generally at 100,
operable to discharge fluid, as a drug, under pressure into a
tube or hypodermic needle. Tube 101 can be one of the delivery
tubes of catheter 21. Dispensing unit 100 has a body or hous-
ing 102 comprising a cylindrical side wall 103 joined to a flat
end wall 104. Side wall 103 surrounds a cylindrical chamber
106 having an open end opposite end wall 104. Oppositely
directed ears 107 and 108 are secured to the open end of the
side wall 103.
Located within chamber 106 is a container or ampulla
indicated generally at 109 for storing fluid, as drugs, tissue
adhesive, water, air, gas, semi-fluids, and the like. Con-
tainer 109 is a collapsible structure having a cylindrical
side wall 111 and bottom wall 112. Bottom wall 112 is located
in flat surface engagement with the inside surface of end wall
104. The center portion of bottom wall 112 has a longitudinal
tubular member 113. A portion of tubular member 113 extends
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through a hole 114 in bottom wall 112. Member 113 has an out-
wardly projected portion 113A and an inwardly directed portion
113B. The midportion of tubular member 113 has a transverse
diaphragm or disc 116 closing the passage through the tubular
member 113. The opposite or top end of the container is closed
with a folded seal 117. A longitudinal needle 118 is located
in the container 109. Needle 118 has a point 119 located in
the upper or inner portion of the tubular member 113. The
opposite end of needle 118 is attached to a transverse head
121. Head 121 is located adjacent the inside of the top wall
of the container 109. As shown in Figure 8, needle 118 is a
generally U-shaped cross section. One side of the needle is
open to the fluid in the container. This allows the fluid to
flow longitudinally along the container past the point 119
when the point pierces the diaphragm 116. The needle can be
a longitudinal tubular member having one or more holes provid-
ing access to the passage in the needle, as shown by needle
73 in Figure 6.
A plunger 122 closes the open end of the housing 102.
Plunger 122 has a pair of diametrically opposite ribs or
projections 123 and 124. The ribs 123 and 124 are located
in longitudinally extended grooves 126 and 127 in the inside
of side wall 103 of the housing to guide the longitudinal
movement of the plunger into the housing. The inner face of
plunger 122 has an annular recess 128 to accommodate portions
of the container when the plunger 122 is moved into chamber
106. The center portion of plunger 122 has a cavity 129 for
accommodating the seal 117 of the container.
In use, referring to Figure 9, force is applied to plunger
122 in the direction of arrow 121. This moves plunger 122
into the chamber 106. The plunger 122 collapses the container
109 and moves the needle through the diaphragm 116. As soon
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as the point 119 of the needle penetrates t}le diaphragm 116,
the fluid within container 109 can flow through the needle
118 into the tube or receiver 101. Fluid will continue to
flow through the needle 118 as long as force is applied to
the plunger 122. Plunger 122 can be moved into chamber 106
until the head abuts against the inner portion of tubular
member 113.
Referring to Figures 10 and 11, there is shown a modifi-
cation of the needle and container arrangement. The bottom
~0 portion of container 132 has a generally flat end wall 133.
The midportion of the end wall has a longitudinal tubular
member 134. The tubular member 134 has an outwardly directed
outer portion 134A and an inwardly projected inner portion
134B. The midportion of the tubular member 134, in general
alignment with the end wall 133, has a diaphragm or disc 136.
A needle indicated generally at 137 is longitudinally aligned
with the passage in the tubular member 134. Needle 137 has
a cone-shaped head 138 terminating in a point. Head 138 is
connected to an elongated shank 139. As shown in Figure 11,
when needle 137 is moved in the direction of arrow 141, head
138 punctures the diaphragm 136. The hole in the diaphragm
136 is larger than the shank 139, allowing the fluid in the
container to flow past the diaphragm 136 into the discharge
portion of the tubular member 134. The outer portion 134C of
the tubular member has threads 142 adapted to receive a female
threaded member, as a nut or sleeve, or a fluid receiving
apparatus. Other types of connections can be used to couple
the tubular member 124 to the fluid receiving apparatus.
Referring to Figures 12 and 13, there is shown a fluid
dispensing container or ampulla indicated generally at 143.
The container has a cylindrical side wall 144 surrounding a
chamber 145 for storing fluid, as drugs, tissue adhesive,
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water and the like. Wall 144 is made of non-collapsible
material. A generally flat transverse end wall 146 is integral
with one end of side wall 144. The center portion of end wall
146 has an elongated longitudinal tubular member 147. Tubular
member 147 has an outer portion 147A extended outwardly from
end wall 146 and an inner portion 147B projected into chamber
145. The midportion of tubular member 147 is closed with a
diaphragm 148. Diaghragm 148 is located in transverse align-
ment with the end wall 146 and is of a material that can be
pierced with a needle.
An elongated longitudinal needle 149 is located within
chamber 145. Needle 149 has a forward end located within the
passage of inner portion 147B and terminates in a point 151.
The opposite end of needle 149 is attached to a transverse
head 152. Head 152 has an annular outer peripheral surface
which forms a seal 153 with the adjacent inner wall of side
wall 144. The outer peripheral surface of the head 152 is in
sealing frictional fit with the inner surface of the side wall
144. The outer peripheral surface of the head 152 is in
sealing frictional fit with the inner surface of side wall 144
so as to prevent moisture, air or other substances from enter-
ing chamber 145. Needle 149 has a generally U-shaped cross
section as shown by needle 118 in Figure 8. Alternatively,
needle 149 can be a tubular member having one or more side
holes to provide a passage for the movement of fluid in chamber
146 out the end of needle 149. The needle can also have the
shape of needle 137, as shown in Figures 10 and 11. Other
shapes and structures can be used to permit the flow of fluid
along the needle through the diaphragm once the diaphragm has
been pierced by the point of the needle.
In use, head 152 is moved into chamber 145 in the direction
of arrow 154 shown in Figure 13. The point 151 of the needle
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will penetrate and pierce the diaphragm 148. Ihe fluid in
chamber 145 is forced along the needle through the pierced
diaphragm and discharged via the outer portion 147~ of the
tubular member.
Referring to Figures 14 and 19, there is shown a con-
tainer or ampulla indicated generally at 160 for storing a
fluid, as a drug, liquid tissue adhesive, semi-liquid material
or a gas. Container 160 is located in longitudinal alignment
with a tubular needle 161. Needle 161 is secured to a gener-
ally transverse base 162 and has a point or sharp edge 163 at
its forward end. Base 162 is mounted in a housing (not shown)
to fix the position of the needle 161.
Container 160 is a one-piece body having a continuous
side wall 164. Side wall 164 has an accordion shape and
is of a cylindrical configuration and surrounds a chamber 166
for storing the fluid. The forward end 167 is closed with a
diaphragm or cylindrical disc member comprising an end wall
167. An outwardly directed longitudinal sleeve 168 is attached
to the outer peripheral edge of the end wall 167 forming an
extension of the container. A disc or pad 169 of resilient
material, as sponge rubber, plastic foam or the like, is
located within sleeve 168 and covers the end wall 167. Sleeve
168 has a rolled outer edge or bead 171 holding the pad within
the sleeve 168.
The rear end of the container is closed with an end wall
172. End wall 172 has a transverse seam 173 closed to moisture
and vapor to seal the container. As shown in Figure 17, the
seam 173 has lapped and inturned edges that are sealed together.
The container is made of a material having moisture and vapor
impervious properties. Preferably the material is deformable
lead alloy which is chemically inert to the fluid stored in
- the container. Other deformable materials having good moisture
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and vapor barrier properties can be used to form the container.
These properties are essential to prevent moisture and vapor
sensitive materials from setting up or polymerizing during
lengthy storage periods. For example, the cyanoacrylate monomer
is extremely sensitive to moisture and vapor. It must be
stored in a sealed container which does not allow ingress of
moisture and vapor. The monomer will set up in a short period
of time when exposed to moisture, including the moisture of
tissues.
In use, force is applied to the end wall 172 in the
direction of arrow 174. This force moves the container 160
into operative engagement with needle 161. The force will
also collapse the side wall 164 and apply sufficient force
to the container whereby the needle 161 will cut through or
pierce both the pad 169 and end wall 167. Pad 169, being made
of resilient elastic material, will be formed with a hole 176
in tight sealing engagement with the outer peripheral surface
of needle 161. Needle 161 will also make a hole 177 in the
end wall 167. Needle 161, being a hollow tubular member,
provides a passage for the flow of fluid from chamber 166 into
a fluid receiver such as the tube of the dispensing catheter.
Referring to Figure 20, there is shown a catheter dis-
penser having a dispensing unit indicated generally at 200
attached to an elongated balloon catheter 202. The dispensing
unit has a body or housing 201 attached to an elongated linear
tube 203 of the catheter. Tube 203 can be an integral extension
of the body or releasably connected to the body 201. The outer
end of the catheter has an expandable sleeve member or balloon
204 adapted to confine fluid, as water or gas, to enlarge the
expandable sleeve member 204. As shown in Figure 22, a second
smaller tube 2n6 is located within the tube 203. Tube 206
extends the entire length of the tube 203 and has an outlet
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opening 205 at the outer end whereby fluid can be discharged
from the catheter. The outer end o-f tube 203 can be recessed
to insure the flow of fluid from outlet opening 205.
The body 201, as shown in Figure 22, has a pair of longi-
tudinally extended chambers 207 and 208. Chambers 207 and
208 are located side-by-side in a generally horizontal plane.
The chambers can be located in a generally vertical plane.
A passage 209 connects the chamber 207 with the passageway of
tube 203. A similar passage 211 connects the chamber 208 with
the passage in tube 206. A short tubular needle 212 extends
longitudinally into passage 207. Needle 212 is attached to
a transverse base 213 positioned at the end of chamber 207
having the passage 209. The outer peripheral edge of base 213
is located in a groove in the housing to fix the position of
the base and needle relative to the passage 207. The needle
212 has a passage in alignment with passage 209 so that fluid
flows through the needle into the passage 209.
A second tubular needle 214 is located longitudinally in
passage 208. Needle 214 is attached to a base 216 located at
the end of chamber 208 adjacent the passage 211. The outer
peripheral edge of base 216 is located in grooves in the housing
201 to fix the position of the base and needle relative to
passage 208. The passage of needle 214 is aligned with the
passage 211 so that the fluid can flow through the needle and
into passage 211.
A container or ampulla 217 having a chamber 218 for
fluid, as drugs, water OT other material, is located in chamber
207. Container 217 has an end or diaphragm 219 facing the
needle 212. A pad 221 of resilient cushioning material is
located between diaphragm 219 and the pointed end of needle
212. A plunger 222 is attached to the opposite end of con-
tainer 217. A suitable dovetail or tongue and groove 237 can
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be used to connect the container to the plunger. Other types
of connections can be used to attach the container to the
plunger. A longitudinal rod 223 is connected to plunger 222
and extended into a bore 224 in the housing 201. A coil spring
226 is positioned around rod 223 and engages the housing 201
and the plunger 222 to bias the plunger toward the needle 212.
A releasable lock 227 engages the rod 222 to hold the
plunger 221 in a cocked position whereby the diaphragm 219
is held from the needle 212. P~eferring to Figures 23 and 24,
releasable lock 227 comprises a cylindrical member or body 228
extended downwardly into a hole 229 in housing 201 through a
cutout or groove 230 in rod 223. The body 228 has a semi-
- circular cutout 231 in alignment with rod 223. The upper or
exposed end of the body 228 has a handle 232. The handle 232
is movable in the direction of arrow 233 shown in Figure 20
to move the cutout 231 in registration with rod 223. When
the cutout 231 is in registration with rod 223, as shown in
Figure 18, the rod is free to move. The spring 226 will bias
plunger 222 toward the needle 212. This moves the container
217 and the diaphragm 219 into the needle 212. The pointed
end of the needle will pass through the pad 221 and puncture
diaphragm 218. The needle 212 will form a seal with the dia-
phragm 219 whereby the fluid in chamber 218 will -flow through
the needle, passage 209 and into the passage of catheter tube
203. The biasing force of the spring 226 will force substan-
tially all of the fluid in chamber 218 through needle 212.
An upwardly directed finger 234, shown in Figure 21, is
attached to plunger 222. The finger 234 extends through a
longitudinal slot 236 in the housing 201. The upper end of
finger 234 is enlarged so that it can be gripped. Plunger
222 and container 217 have cooperating connections such as a
dovetail connection 237, shown in Figure 22. When force is
- 20 -
~(}6979~
applied to finger 234, the plunger 222 can be moved in a reverse
direction, expanding the container 217. This withdraws the
fluid from the catheter, decreasing the size of the expandable
member 204. The plunger 222 can be moved until lock 227 can
be moved to fix the position of the plunger 222 in the housing.
Other types of retraction structure can be used to withdraw
and expand the container 217 to relieve the fluid from the
expandable member 204.
A container or ampulla 238 is located in chamber 208
adjacent the needle 214. Container 238 has a chamber 239 for
storing drugs, tissue adhesive and other materials. Container
238 has an end or diaphragm 241 spaced from the pointed end
of needle 214 with a resilient pad 242. Some drugs that are
moisture and vapor sensitive require a container made of
material having good moisture and vapor barrier properties.
Preferably a deformable lead alloy is used to make this type
of container. These properties are important to prevent
moisture and vapor sensitive materials from polymerizing or
setting up during storage periods. The material of the con-
tainer is also chemically inert to the fluid stored in the
container. Located adjacent the opposite end of container
238 is a plunger 243. A longitudinal rod 244 attached to
plunger 243 extends into a bore 246 in housing 201. A spring
247 located in ch amber 208 engages the housing 201 and plunger
243 to bias the plunger toward the needle 214. The rod 244
is held with a releasable lock 248. Lock 248 is identical to
lock 227. It is operated by moving the handle of the lock to
the dotted line position, as shown in Figure 14. This releases
the rod 214 whereby the spring 247 will bias the plunger in
a forward direction, moving the diaphragm 241 toward the needle
214. The pointed end of needle 214 will pierce diaphragm 241,
thereby providing a fluid connection between the chamber and
- 21 -
~Q69~91
the passage 211 leading to the tube 206. The diaphragm will
be located in sealing realtion with respect to the needle
whereby the fluid in chamber 239 of container 238 will be
forced by the biasing action of the spring 247 through the
needle 214, the passage 211 and the passage of the tube 206.
Body 201 has doors or closure members closing openings
into the chamber 207 and 208 whereby the containers 217 and
238 can be removed and replaced. Other types o containers
as herein disclosed can be inserted into the chambers.
Referring to Figure 25, there is shown a modification
of the releasable lock, indicated generally at 250. Lock 250
has a body or rod 251 having a cylindrical cutout 252. The
rod 223 attached to the plunger has a similar cutout. A spring
253 located in the base of bore 224 biases the body 251 in an
upward direction. The upper end of body 252 is attached to a
head 254.
In use, body 251 has a portion located in the groove or
recess in the side of the rod 223 to hold the rod in the cocked
position, as shown in Figure 22. The rod 223 is released by
pushing head 254 in a downward direction, as indicated by arrow
256, until the cutout 252 is aligned with rod 223. This
releases the holding action on rod 223 whereby the spring 226
can move the rod in a forward direction, forcing the diaphragm
219 into engagement with the needle 212.
Referring to Figures 26, 27, 28 and 29, there is shown
a further modification of a dispenser catheter of the invention
indicated generally at 300 for discharging fluid, as drugs,
tissue adhesives, and the like, into the uterine cavity. The
dispenser catheter 300 has a dispensing unit 301 and an elong-
ated tubular catheter 302. Dispensing unit 301 has a body 303
attached to elongated tube 304 of the catheter. Tube 304 can
be releasably connected or permanently fixed to body 303.
~06~7~i
Mounted on the end of tube 304 is an expandable sleeve member
or balloon 305. Bands 306 clamp the ends of sleeve member 305
to tube 304. Sleeve member 305 is an elastic sheet member, of
relaxed rubber, plastic or like materials. When the sleeve
member 305 is expanded in the uterine cavity, it applies uniform
outward pressure on the uterine wall. The expanded sleeve
member 305 prevents the drugs injected into the uterine cavity
from contacting substantial portions of the uterine wall and
flowing out of the uterine cavity. Holes 307 in the end of
tube 304 provide the passageway for the fluid, as water, from
within the tube 304 into the area surrounded by the sleeve
member 305 to expand sleeve member 305. An elongated small
tube 308 is located within tube 304. Tube 308 has a discharge
end 3ng at the outer end of tube 304.
Body 303 has a pair of side-by-side chambers 311 and 312.
Chambers 311 and 312 extend in a longitudinal direction and
are located in a common horizontal plane. The chambers can
be located in a common vertical plane whereby one chamber is
positioned over the other chamber. A passage 313 connects
chamber 311 with the tube 304. In a similar manner, a passage
314 connects chamber 312 with the tube 308.
A first plunger 316 is movably positioned in first chamber
311. A rearwardly directed rod 317 is attached to plunger 316.
A second plunger 318 is movably located in chamber 312. A rod
319 is secured to the plunger 318 and extends in a rearward
direction generally parallel to the rod 317. A trigger assembly
or actuator indicated generally at 320 is mounted on the rear
portion of the housing adjacent the rear end of rods 317 and
319.
Trigger assembly 320 has a lever 321. The midportion of
lever 321 has a hole accommodating a transverse pivot pin 322.
Pivot pin 322 is anchored in a downwardly extended handle or
~n6s7sl
pistol grip 323 secured to the rear portion of the body 303.
Lever 321 has a transverse head 324. A spring 325 engages
the body 303 and upper end of lever 321 to bias the lever in
the rear or cocked position. The forward portion of head 324
is in sliding engagement with the ends of rods 317 and 319.
Referring to Figures 29 and 30, head 324 has a longitud-
inal passage 326 for accommodating rod 319. A transverse bore
327 opens into passage 326. Slidably disposed in bore 327 is
a pin 328. Pin 328 has a reduced diameter neck 329 attached
to an enlarged head 331. A spring 332 engages the head 331
and a plug 333, closing the end of bore 327. Spring 332 biases
the pin 328 into the passage 326. Rod 317 has a rearwardly
directed finger 334. When rod 317 is in the rearward or cocked
position, the finger 334 is located behind the head 331 and
functions as a stop to prevent movement of pin 328 into passage
326.
Returning to Figure 27, rod 317 has a notch or slot 336
in the upper portion thereof. The slot 336 cooperates with
lock 337 to hold rod 317 in the dispensed or "in" position.
Lock 337 comprises a movable pin 338 located in a passage
surrounded by a boss 339. The pin 338 has a head 341 located
above body 303 so that it can be gripped to release the lock.
The forward portion of the pin carries a C-ring or clamp ring
342 providing a stop for a spring 343. Spring 343 is located
concentrically around the pin and engages a portion of the
body 303 to bias the pin 338 toward rod 317. When rod 317 has
been moved to the "in" position, the pin 338 will be biased
into the slot 336, thereby holding the pin in the "in" position.
The rod 319 has a slot 344. A lock 346 on body 303 holds the
pin in the "in" position. Lock 346 is identical to lock 337.
Returning to Figure 30, when the lever 323 has been actu-
- ated, the rod 317 will be held in the "in" position by lock
- 24 -
:`
10~'7~1
337. Rod 319 is not moved because the head 324 will move
relative to rod 319 as rod 319 moves through passageway 326.
When the head 324 is returned by spring 325 to its initial
rearward position, the pin 328 will be biased by spring 332
into passage 326. The second actuation or movement of the
lever 321 toward the handle 323 will move the rod 319 in the
forward direction.
Referring to Figure 28, a first container or ampulla
indicated generally at 350 is located in chamber 311. A for-
wardly directed needle 351 mounted on a transverse base 352
is locat~d at the forward end of chamber 311. Needle 351 is
a hollow member in fluid communication with passage 313.
A second container or ampulla, indicated generally at353, is located in passage 312. The forward end of passage
312 has a longitudinally extended needle 354 mounted on a
transverse base 356. Needle 354 is a hollow tubular member
having a passage in fluid communication with the passage of
the tube 314. The container 353 is an elongated cylindrical
: member of glass~ plastic or the like having a head 357. The
head has a rubber plug (not shown) in alignment with needle
; 354. Slidably positioned within the container is a plunger
of piston 358 confining fluid 359 in the container. The plunger
318 is slidably positioned within the container and engageable
with the piston 358. On movement of plunger 318 in the forward
direction, head 357 will be driven through needle 354, thereby
providing a fluid communication between the chamber of the
container 353 and tube 314. The piston 358 will be moved in
a forward direction to drive the fluid from the container.
The fluid can be a drug, tissue adhesive, or semi-fluid material
for treating and occluding the canals of the Fallopian tubes.
Container 350, shown in Figure 31, has a cylinder 361 for
storing fluid 362, as drugs, water or the like. The forward
- 25 -
7~
end of cylinder 361 has a head 363 having a passage closed
with a plug 364. The open end of cylinder 361 is closed with
a plunger 366 carrying a piston 367. The rear portion of
plunger 366 has an outwardly directed flange 368 engageable
with a spring 369. The forward end of spring 369 engages an
annular seat 371 on the cylinder 361 to bias the plunger 366
in an outward direction or out of cylinder 361. Plunger 366
has a central longitudinal bore 372 slidably accommodating an
actuator rod 373. Rod 373 has an axial bore accommodating a
compression spring 374 to provide a yieldable link between
rod 373 and plunger 366.
Plunger 316 attached to rod 317 engages the end of rod
376. On movement of plunger 316 in the forward direction,
spring 374 will be initially compressed applying a uniform
pressure on plunger 366. The cylinder 361 will be moved in
a forward direction whereby needle 351 will pierce plug 364,
providing fluid communication between the container and passage
313. The continued movement of the plunger 316 will drive the
piston 367 toward the plug 364, thereby dispensing the fluid
from cylinder 361. The dispensed fluid will flow through tube
304 and into sleeve member 305 via holes 307 to expand sleeve
member 305, as shown in broken lines in Figure 22. ~leeve
member 305 will expand with a uniform pressure so as to fill
the uterine cavity and exert uniform pressure on the inside
wall of the cavity. The pressure of sleeve member 305 on the
cavity wall will be uniform regardless of the size of the
uterine cavity.
Body 303 has doors or closure members closing openings
into the chambers 311 and 312 whereby the containers 350 and
353 can be removed and replaced. Other types of containers,
as disclosed herein, can be inserted into the chambers.
- 26 -
1~9791
In use, the dispensing catheter performs a method of
introducing a material, as a drug, tissue adhesive, contra-
ceptive gel or like material, into the canals of the Fallopian
tubes. The method includes the introduction of an elongated
catheter 302, with sleeve member 305 in the contracted position,
through the cervical opening into the uterine cavity. Sleeve
member 305 is expanded with fluid under pressure to fill the
uterine cavity and apply uniform pressure on the inside of
the uterine wall. The fluid under pressure is delivered to
sleeve member 305 via the passage in the tube 304. Actuator
320 is moved in a forward direction to force plunger 316 in a
direction to move the container 350 into operative engagement
with needle 351. Needle 351 will puncture the plug 364, whereby
the fluid 362 will flow via the passage in tube 304 to expand
sleeve member 305. The sleeve member, being a sheet of flex-
ible, elastic rubber or similar material, has a low surface
tension and applies a uniform expansion force to the inside
of the uterine wall. This effects a relatively tight seal and
fit, enabling the same catheter construction to be used on
all types of primate female, regardless of the size of the
uterine cavity.
The material under pressure is then dispensed into the
~- uterine cavity between the expanded sleeve member and the
fundus of the uterus. The material, being under pressure,
moves toward and into the canals of the Fallopian tubes. The
expanded sleeve member, being located against the fundus wall,
aids the movement of the material toward the canals of the
Fallopian tubes. The material can be a fluid tissue adhesive
which will flow into the canals. The moisture in the tissue
of the canals will polymerize or set the tissue adhesive and
thereby block or occlude the canals. The fluid confined by
the sleeve member is drained to contract the sleeve member.
~Oti979~
The catheter is then withdrawn from the uterine cavity.
Referring to Figure 32, there is shown the dispensing
instrument indicated generally at 420 with the probe located
in the uterine cavity. The female reproductive system shown
generally at 421 has a uterus 422 joined to a pair of Fallopian
tubes 423 and 424. The lower part of uterus 422 is integral
with an elongated vagina 426. Vagina 426 has a vaginal cavity
427 having an opening or entrance 428. The opposite end of
vaginal cavity 427 is in communication with the cervix 429.
Cervix 429 has a cervical opening 431 providing a passage from
vaginal cavity 427 to uterine cavity 432. Fallopian tubes 423
and 424 have exits 433A and 434A at opposite sides of the upper
part of the uterine cavity 432.
The uterus 422 is a generally pear-shaped, thick walled,
hollow organ situated between the bladder and rectum. The
- uteri of females vary in size and shape. Wall thickness, wall
strength and sensitivity to pain may vary from female to female.
The size and configuration of the uterine cavities can vary.
The uterine cavity 432 is generally flattened and triangular
in shape. Some uteri have cavities that have other shapes.
The Fallopian tubes 423 and 424 are paired, trumpet-shaped
muscular members about 12 cm. in length which extend from the
superior angles of the uterine cavity 432 to the ovaries (not
shown). The outlets 433A and 434A of canals 433 and 434,
respectively, can vary in positon relative to the uterine
cavity and relative to each other. Outlets 433A and 434A are
usually symmetrically opposite each other, as shown in Figure
32, and their position and proximity are principally related
to the uterine size and configuration. Also, the size of the
canals 433 and 434 and the size of outlets 433A and 434A vary
from female to female.
- 28 -
3 0~''3'é~
Fallopian tubes are commonly divided into isthmus, intra-
mural and ampullary sections. Canals 433 and 434 provide
passages for the movement of ova from the ovaries to the uterine
cavity 432 as well as the movement of sperm from the uterine
cavity toward the ovaries. The intramural sections of the
Fallopian tubes traverse the uterine wall generally in a more
or less straight fashion, but their course may be tortuous in
some females. The walls of the Fallopian tubes consist of
three layers; the serosal layer, the muscular layer and the
mucosal lining.
Uterus 422 has a top wall or fundus 436 and side walls
437 and 438 which surround the uterine cavity 432. The inside
of top wall 436 and the insides of side walls 437 and 438 have
an inside lining or membrane 439 which is periodically sloughed
off in the normal cycle of the female.
Dispensing instrument 420 has an elongated probe or tubu-
lar member 441 having a length sufficient to pass through the
vaginal cavity 427 and into uterine cavity 432. Member 441
has a longitudinal passage 442 extended throughout its length.
A balloon assembly indicated generally at 443 is mounted on
the upper or outer end of tubular member 441. Balloon assembly
443 has a flexible and expandable sleeve member 444 surrounding
the upper end of probe 441 A fastener 446, as a collar or
thread, attaches the upper end of sleeve 444 to probe 441.
similar fastener 447 attaches the opposite end of sleeve 444
to the probe 441. Probe 441 has a plurality of openings 448
which provide communication between the passage 442 and a
chamber 449 within sleeve member 444.
Sleeve member 444 is a tubular sheet member of soft and
relaxed, flexib~e and elastic mateiral, as rubber or plastic,
which expands with a miimum of tension. For example, thin
latex rubber having low surface tension is suitable material
- 29 -
106979~
for sleeve member 444. The low surface tension of the rubber
allows the rubber to uniformly expand with relatively low
pressure. The material of sleeve member 444 readily expands
to displace uterine cavity 432 by conforming to the shape of
the uterine cavity without applying extreme pressure to local-
ized portions of the uterus walls 437 and 438. I~hen cavity
432 is fully displaced with sleeve member 444, as shown in
Figure 36, sleeve member 444 is in uniform surface engagement
with the inside lining 439. Conventional balloon catheters,
being of hard, relatively non-elastic material, do not assume
the configuration of the uterine cavity when expanded.
The upper or outer end of probe 441 is closed with a head
451. Head 451 has a transverse passage 452 open to opposite
sides of head 451. An elongated tube 453 is secured to the
head 451. Tube 453 extends the length of probe 441 and has a
passage 454 for carrying a drug material to the transverse
passage 452 which directs the drug material in opposite direc-
tions in two portions into the upper section of the uterine
cavity 432. Head 451 has a longitudinal section or cap 456
having a top surface or wall adapted to engage the inner wall
of fundus 436. The cap 456 spaces the passage 452 from the
inner wall of fundus 436.
Referring to Figure 33, dispensing instrument 420 has an
elongated housing or body 457 attached to the end of probe 441.
Body 457 has a first chamber 458 accommodating an elongated
cylinder 459. Cylinder 459 has a forwardly directed neck 461
connected to a tube 462. Tube 462 has a passage which is in
communication with passage 442 of the probe 441 so that fluid,
as air, in cylinder 459 can flow via passage 442 into chamber
449 of the balloon assembly and thereby expand the sleeve
member 444. The open end of cylinder 459 is closed with a
piston 463 to trap the fluid in chamber 464. The cylinder 459
- 30 -
106~791
has a hole 466 adjacent the piston 463 to allow air and steril-
izing gases to flow into the chamber 464.
Located rearwardly of the piston 463 is a first drive
assembly indicated generally at 467 operable to move the piston
463 into cylinder 459. I`he first drive assembly 467 is con-
nected to an actuator 468 projected rearwardly from body 457.
Body 457 has a second chamber 469 located adjacent one
side of the first chamber 458. A tube 471 is mounted in the
body 457 to connect the tube 453 to chamber 469. Tube 471 has
a longitudinally extended needle 472 projected into chamber
469. The opposite end of tube 471 is mounted in a plug 473
closing the end of probe 441 and connected to the tube 453
which leads to head 451. Chamber 469 has an elongated shape
and is open to the top of body 457, as shown in Figure 32. A
cylindrical container or ampulla 474 is located in chamber 469
in alignment with needle 472. I'he forward end of container
474 has a pierceable plug 476 aligned with needle 472. The
open end of container 474 is closed with a slidable piston 477
to trap drug material 478 in container 474.
A second drive assembly indicated generally at 479 extends
rearwardly form container 474 and is drivably connected to
actuator 468. Actuator 468 is operable to complete the entire
dispensing of drug material into the canals of the Fallopian
tubes in a single stroke. The rear portion of housing 457
has outwardly and oppositely directed flanges 481 and 482
which serve as finger grips during actuation of actuator 468.
Actuator 468 has a hole 483 for accommodating a pin 483A to
hold the actuator 468 in the operative position. The pin 483A
prevents accidental actuation of the dispensing instrument.
Drive assembly 467 is a force-transmitting mechanism
operable to move piston 463 into cylinder 459 and thereby
increase the pressure in the fluid system for the balloon
:1069791.
assembly 443 and expand sleeve member 444. Drive assembly
467 has a cylinder or sleeve 484 slidably carrying a body 486.
The opposite or upper end of sleeve 484 is attached to a head
487. Head 487 has a central hole 488 which provides access
into sleeve 484. The outer end of piston 463 has a cone-shaped
portion 48g to accommodate the cone-shaped outer end of head
487. The hole 488 is aligned with an adjusting screw 491
threaded into body 486. The position of screw 491 relative
to body 486 can be changed with the use of a tool, as a screw-
driver, extended through hole 488. A pair of springs 492 and
493 bias the sleeve 484 and body 486 in opposite directions
whereby the first drive assembly 467 is biased into its elong-
ated position. Spring 492 abuts against head 487. Spring 493
rests on screw 491. Adjusting the positon of screw 491 adjusts
the tension or force of the spring 493 which biases the head
487 and body 486 in opposite directions. Screw 491 performs
a fine adjustment of the spring force to accommodate variations
in spring 493 and to provide for desired fluid pressure in
chamber 449. A washer 494 having a central hole for rod 488
is located between springs 492 and 493. Spring 492 is a light
or weak spring as compared to spring 493. The weak spring 492
will compress under a light load, for example 2-3 psi, whereby
the washer 494 will abut against head 487. This insures the
partial expansion of sleeve member 444 at low predetermined
maximum pressure. The predetermined maximum pressure is deter-
mined by the compression force characteristics of spring 493
and permits the instrument to be used with all shapes and sizes
of uteri, as the spring 493 adjusts for the differences in the
uteri.
Sleeve 484 and body 486 are held in assembled relation
with a pin 496 extended through elongated longitudinal slot
497 in sleeve 484. Slot 497 permits the sleeve 484 to move
~069791
relative to body 486 as the springs 492 and 493 are compressed.
Pin 496 projects through slot 497 into an elongated linear
groove 498 in the housing 457 and thereby prevents rotational
movement of the drive assembly 467 relative to housing 457.
Body 486 has a transverse passage 499 accommodating a
drive link 501. The drive link S01 has spherical members at
its opposite ends joined with a transverse member or tube.
The first end of drive link 501 is located in a recess 502 in
the side of actuator 468. Actuator 468 has a second recess
503 for accommodating the link 501. Located below recess 503
is a shoulder 504 adapted to engage the end of body 486 when
link 501 is in recess 5n3. Housing 457 has a recess 506 adapted
to accommodate the opposite or right end of drive link 501.
Recess 506 is located in a forward direction from the initial
- position of drive link 501, as shown in Figure 33, so that the
actuation of drive assembly 467 is temporarily halted or inter-
rupted until the end of body 486 engages the shoulder 504, at
which time the movement of the drive assembly 467 is contin-
ued. The locations of recesses 506 and 521 in housing 457 can
be coordinated with each other so that the initial expansion
of sleeve member 444 overlaps the discharge of drug material
into the uterine cavity and the continued expansion of sleeve
member 444. In this case, sleeve member 444 has a continuous
expansion until the sleeve member 444 has been subjected to the
maximum fluid pressure.
A lock unit indicated generallv at 507 is movably located
in a bore 508 iII body 486. Lock unit 507 has a plunger 509
carrying an outwardly directed finger or projection 510. Finger
510 is adapted to engage one of a plurality of teeth 511 loc-
ated in housing 457. The teeth 511 face drive assembly 467.
Teeth 511 are ratchet teeth which allow only reverse movement
o-f the drive assembly when lock unit 507 is in operation posi-
~(~69791
tion with teeth 511. Plunger 509 is biased in an outward
direction with a spring 512 located at the base of bore 508.
Sleeve 484 has a hole 513 spaced forwardly from finger 510.
On compression of springs 492 and 493, the body 486 moves
relative to sleeve 484 until the finger 510 is aligned with
hole 513, at which time spring 512 will bias finger 510 through
hole 513 into engagement with one of the teeth 511. This
prevents further movement of the drive assembly 467 in a forward
direction and limits the pressure of the fluid in the chamber
449 of sleeve 444.
The second drive assembly 479 is operable to drive the
container 474 onto needle 472 and force piston 477 into the
container and thereby drive the drug material 478 through
needle 472 into tube 453. Tube 453 carries the fluid to head
451 where it is discharged in opposite directions into the
upper portion of uterine cavity 432. Returning to Figure 2,
second drive assembly 479 has an elongated linear plunger 514
slidably located in a longitudinal passage 515 in housing 457.
Plunger 514 has a forward end 516 adapted to engage piston 477.
The opposite end of plunger 514 has a transverse passage 517.
A movable drive link 518 is located in passage 5170 Link 518
has spherical ends that are connected with a rigid member such
as a tube. One end of drive link 518 is located in a semi-
spherical recess 519 located in the side of actuator 468. The
opposite end of drive link 518 rides on the side wall of the
housing 457 forming part of passage 515, thereby retaining
the link in recess 519. Housing 457 has a recess 521 forward
of the link 518 so that the link 518 will remain in driving
relationship with actuator 468 until the link is aligned with
recess 521. At this time the link 518 will be forced into
recess 521 whereby actuator 468 will continue to move in a
forward direction and plunger 514 will remain stationary.
- 34 -
~069791
In use, the dispensing instrument 420 is packaged with
container 474 located in chamber 469. Actuator 468 is locked
in an inoperative position with a pin 483A extended through
hole 483. Pin 483A engages the end of housing 457 to prevent
actuator 468 from moving into the housing. The entire dispen-
sing instrument is sterilized before it is used.
The operating procedure begins with inserting the balloon
assembly 443 into the vaginal cavity 427, through cervical
opening 431 and into uterine cavity 432, as shown in Figure 32.
Sleeve member 444 is in the collapsed condition so that the
balloon assembly can be readily positioned in the uterine
cavity. The probe 441 is moved into the uterine cavity until
head 451 engages the fundus 436. It is known that uteri can
vary in size, shape and position so that the balloon assembly
may or may not be symmetrically located relative to the Fallop-
ian tubes 423 and 424. As shown in Figure 32, balloon assembly
443 is centrally located in the uterine cavity 432. In some
cases, the balloon assembly may be angularly positioned in the
uterine cavity adjacent one side of the cavity. Dispensing
instrument 420 is effective in placing drug material into both
canals of the Fallopian tubes regardless of the position of
the balloon assembly in uterine cavity 432.
Pin 483A is removed from hole 483, making plunger 468
ready to be moved into the housing 457 to inflate the expandable
sleeve member 444 and dispense drug material into uterine
cavity 432 and then fully expand the sleeve member 444 to pump
or force the drug material into the canals of the Fallopian
tubes. The operator uses -f~anges 481 and 482 as finger rests
so that inwardly directed force can be applied to the actuator
468. As shown in Figure 35, the actuator 468 has been moved
into housing 457 a short distance such that the first drive
assembly has moved the piston 463 into cylinder 59. This
- 35 -
~n~
expands sleeve member 444 so that it forms a plug or seal in
the lower portion of the uterine cavity 432. Sleeve member 444
is expanded into firm engagement with the inside lining or
membrame 439. Drive link 501 couples actuator 468 to the
first drive assembly 467 to transmit the motion of actuator
468 to the first drive assembly 467. This moves piston 463
into chamber 464. The drive link 518 couples plunger 514 with
actuator 468 so that the forward end 516 of the actuator engages
piston 477 in the container 474. This moves the entire con-
tainer 474 in a forward direction. The needle 472 pierces
plug 476, thereby moving the needle through plug 476 and into
the chamber containing the drug material 478. The drive link
101 is aligned with recess 506 in the housing 457. This
permits the drive link 501 to move to the right, as shown in
Figure 35,releasing the drive link from the actuator 468. The
continued movement of the actuator 468 applies force to plunger
416 which moves piston 477 into container 474. Drug material
478 is forced via tubes 471 and 453 to head 451. The drug
material is discharged in opposite directions via the trans-
verse passage 452 into the upper part of uterine cavity 432.
As shown in Figure 36~the continued movement o-f actuator
468 places the shoulder 504 in engagement with the bottom of
body 486. At the same time drive link 501 moves into recess
503, thereby releasing drive link 501 from recess 506. Actu-
ator 468 is moved into housing 457, thereby increasing the
pressure in chamber 464. This further expands sleeve member
444. The expanding sleeve member 444 drives the drug material
from the upper portion of the uterine cavity through exit
openings 433A and 434A of the canals 433 and 434 of the Fallop-
ian tubes. The sleeve member 444 continues to expand until
the fluid pressure in the system containing the sleeve member
and chambers 449 and 464 is approximately 8 psi. Other pressures
- 36 -
~)69791
can be selected as the upper pressure limit. This pressure is
determined by the compression characteristics of the springs
492 and 493 and adjusting screw 491. The compression of spr~ngs
492 and 493 permits body 486 to move into sleeve 484. This
movement continues until finger 510 is aligned with opening 513.
When finger 510 and hole 513 are aligned, the spring 512 forces
finger 510 through hole 513 and into the space between adjacent
teeth 511. Finger 510 anchors on a forward tooth, thereby
preventing further movement of the actuator 468 into housing
457. Since actuator 468 is prevented from moving into the
housing 457 by lock unit 507, the pressure in the balloon
chamber 449 is limited to a selected maximum pressure, depend-
ing on the compression characteristics of springs 492 and 493.
As the actuator 468 is moved into housing 457 from the
position shown in Figure 35 to the position shown in Figure 36,
drive link 518 moves from recess 519 into recess 521. This
terminates the forward motion of plunger 514 to stop dispensing
the drug material into uterine cavity 432. The continued
movement of actuator 468 increases the fluid pressure in the
chamber 449, thereby expanding sleeve member 444 to pump or
push the drug material from uterine cavity 432 into canals 433
and 434 of the Fallopian tubes. The pumping action ceases
when the sleeve member 444 is fully expanded, as shown in Figure
36. This locates the drug material in the Fallopian tubes as
the pumping force applied to the drug material is insufficient
to move the drug material through the Fallopian tubes into the
body cavity.
The actuator 468 is then pulled out of housing 457. Drive
link 501, being located in recess 503, provides a drive con-
nection between body 486 and plunger 468. Finger 510 of lock
unit 507 slips over teeth 511. This pulls the piston 463 out
of chamber 464. The fluid in chamber 449 flows back into
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chamber 464, contracting sleeve member 444. This releases
sleeve member 444 from engagement with lining 439 and enables
balloon assembly 443 to be withdrawn from the uterus of the
patient.
When drug materials of the cyanoacrylate tissue adhesive
type are used, canals 433 and 434 will be permanently occluded.
Tissue adhesives, as the cyanoacrylate type, cause fibroblastic
proliferation which in time closes the canals 433 and 434. The
tissue adhesives polymerize when exposed to a hydroxyl ion
source, such as water. The cells adjacent the adhesive are
damaged and are eventually replaced with fibrous tissue. Cer-
tain other tissue adheisves will polymerize in response to body
heat or other stimuli.
- In terms of method, the dispensing instrument is used to
place drug material in both canals of the Fallopian tubes via
the uterine cavity. The contracted balloon assembly is initi-
ally placed in the uterine cavity, as shown in ~igure 32,"b~y
inserting the balloon assembly 443 through cervical opening
431. The actuator 468 is then released so that it can be moved
into housing 457. The operator moves the single actuator 468
with a continuous movement into housing 457 to complete the
operation. The first drive assembly 467 and second drive
assembly 479 are coordinated to sequentially operate to parti-
ally expand the sleeve member 444 to displace the lower portion
of the uterine cavity and form a seal with the lower walls of
the uterine cavity. The plunger 514 then engages the piston
477 to force the container onto needle 472 and force drug
material 478 from the container and discharge the drug material
in opposite directions into the uterine cavity 432 above the
partially expanded sleeve member 444. This operation is shown
in Figure 35. The continued movement of actuator 468 further
expands the partially expanded sleeve member 444 to fully
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displace uterine cavity 432. This is done by subjecting the
sleeve member 444 to fluid under pressure by moving the piston
463 into chamber 464. The actuator 468 will continue to move
until lock unit 507 engages one of the teeth 511, thereby
preventing further expansion of the sleeve member 444. The
sleeve member 444 can only be subjected to a maximum predeter-
mined pressure so as not to place undue pressure on the walls
of the uterus. The expanding sleeve member 444 forces or pumps
the drug material that has been discharged into the uterine
cavity through the openings 433A and 434A and into canals 433
and 434 of the Fallopian tubes. Sleeve member 444 is then
contracted by relieving the pressure applied thereto. This is
done by pulling actuator 468 out of housing 457 so that the
fluid can move into container chamber 464. The instrument is
then removed from the uterine cavity via the cervical opening
and vaginal passage.
The drug material can be one of a number of fluids or
semi-fluids used to test, treat or occlude the canals of the
Fallopian tubes. For example, the drug material can be a
tissue adhesive. The tissue adhesive can be a cyanoacrylate-
type material or like material used as surgical glue. Cyano-
acrylate is a liquid plastic which sets up or polymerizes in
response to moisture and thereby functions to occlude the
canals of the Fallopian tubes. The cyanoacrylates include,
but are not limited to, methyl cyanoacrylate, methyl-2-cyano-
acrylate, ethyl cyanoacrylates, n-propyl cyanoacrylates, n-butyl
cyanoacrylates, n-amyl cyanoacrylates, n-hexyl cyanoacrylates,
n-heptyl cyanoacrylates, isobutyl-2-cyanoacrylates and n-octyl
cyanoacrylates. The drug material can also be of a type that
sets up in response to body heat or other stimuli. It may be
a type which produces permanent occlusion or of a type which
will temporarily block or occlude the canals of the Fallopian
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tubes, after which the canals will be reopened and resume
their normal function. Examples of other types of drug mater-
ials are contraceptive gels, water, silicone elastomers,
formaldehyde-type materials and like materials.
Referring to Figures 37 and 38, there is shown a modifi-
cation of the dispensing instrument indicated generally at
420A. Dispensing instrument 420A and the fenale reproductive
system associated therewith follow the dispensing instrument
shown in Figures 32-36. Corresponding parts of the instrument
and reproductive system have the same reference numerals with
the suffix A.
Dispensing instrument 420A uses a two-part drug material
which is mixed at the end of the probe as it is forced into
the upper part of the uterine cavity 432A. The mixed drug
material of the sleeve member 444A to displace uterine cavity
432A.
Head 651 is mounted on the outer end of the probe or
tubular member 441A. The head 651 has a transverse passage
652 having oppositely directed discharge openings for directing 20 the drug material in two parts into the upper part of the
uterine cavity 432A. A first tube 653 and a second tube 654
are connected to the head 651. The head has a mixing chamber
or passage 655 in fluid communication with the passages of
tubes 653 and 654 and the transverse passage 652. The drug
materials flow through the tubes 653 and 654 and are mixed in
chamber 655. The mixing continues as the drug materials are
separated and forced in opposite directions in passage 652, as
indicated by the arrows.
Housing 457A has a pair of chambers 656 located adjacent
chamber 458A for accommodating a pair of ampullae or containers
657 and 659. Container 657 stores a first drug material 658.
Container 659 stores a second drug material 660. A first
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piston 661 is slidably located in container 657. In a similar
manner, a piston 662 is slidably located in container 659.
Plunger 514A of the second drive assembly 479A has a bifurcated
end forming a pair of fingers 663 and 664. Finger 663 is posi-
tioned in container 657 and engages piston 661. Finger 664 is
located in container 659 and engages piston 662. The tubes
653 and 654 extend into housing 457A and terminate in needles
666 and 667. Needles 666 and 667 are in alignment with the
pierceable end portions of containers 657 and 659.
ln On actuation of single actuator 468A, the first drive
assembly 467A will operate to initially expand the sleeve
member 444A to fill and seal the lower portion of the uterine
cavity 432A. Continued movement of actuator 468A will engage
the second drive assembly 479A to move the fingers 663 and
664. Plunger 514A moves in a forward or upward direction, as
shown in Figure 6, to drive the containers 657 and 659 onto
needles 666 and 667, respectively. Fingers 663 and 664, being
in engagement with pistons 661 and 662, simultaneously force
the drug materals 658 and 660 through the tubes 654 and 653.
The drug materials are simultaneously discharged into the mix-
ing chamber 655. Substantially the same amounts of drug mater-
- ials are introduced into the mixing chamber 655 so that the
mixture of drug materials contains about 50 per cent of the
first drug and 50 per cent of the second drug material. The
mixed drug material, indicated at 668 in Figure 37, is intro-
duced into the up er part of uterine cavity 432A. The mixed
drug material 668 flows in opposite directions in substantially
equal amounts. The flow is continuous until plunger 414A has
reached the end of its stroke. At this time, the continuous
movement of the actuator 468A further expands the sleeve member
434A forcing the mixed drug material into the canals 433A and
434A of the Fallopian tubes.
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Drug materials 658 and 660 can be the type which when
mixed will set up to form a sem-rigid plastic material. The
mixture can be responsive to moisture in the tissues to set up
or responsive to body heat or other factors to set up. The
mixture has a reaction time such that it can be introduced
into canals 433A and 434A before it will set up. The following
is an example of the materials o-f the two-part drug material.
The two-part drug materials may be two-part epoxies, two-part
tissue adhesives, silicone RTV, or a polymer consisting of Dow
~a~ 2Cr4~en~q~fk)
10 ~ Corning Silasticl382 Medical Elastomer and 360 Medical Fluid.
It is understood that other types of drug materials that are
mixed and set up can be used. Furthermore, the ratio of the
drug material can be varied by increasing the si~e of one of
the containers. ~or example, two parts of the first drug
material can be mixed with one part of the second drug material
by using the appropriate size containers in the housing 457A.
The drug material can be a contraceptive drug for local
action in the Fallopian tubes and uterus. For example, bio-
absorbable microspherules having contraceptive drugs, as pro-
gestins, can be delivered to the canals of the Fallopian tubes.
The microspherules break down over a period of time, i.e., one
year, thereby inhibiting conception during this period.
Biologicals, as fibrinolytic enzymes, can be introduced
into the canals of the Fallopian tubes and uterine cavity to
treat the tissues. The biologicals are used to treat-inflam-
mation and prevent adhesions from forming around the ends of
the Fallopian tubes.
Diagnostic materials can be introduced into the canals of
the Fallopian tubes with the apparatus and method of the inven-
tion. These materials include oil base and aqueous base X-ray
dyes and color indicator dyes, as methylene blue and indigo
carmine and the like.
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Anesthetic materials can be introduced into the canals
of the Fallopian tubes with the apparatus of the invention.
The drug material can be of the type which treats the
canals and uterus to enhance the flow of ova and sperm in the
canals and uterus. The drug material can include material
which expands or opens the canals or passages of the Fallopian
tubes to enhance fertilization or conception. At the present
time there are several materials or chemicals which are used to
. .
treat the canals of the Fallopian tubes to enhance fertilization
- 10 or conception. Anti-inflammatory agents, as cordocoids, can
be used to locally treat inflammation. Antibiotics can also be
used for local treatment of the Fallopian tubes.
It is believed that in some cases of infertility the sperm
are blocked or unable to transport themselves across the cervix
and endometrial cavity. The apparatus and method of the inven-
tion is usable to deliver sperm into the uterine cavity and canals
of the Fallopian tubes to enhance conception.
While there have been shown and described preferred
embodiments of the dispensing instrument and method of intro-
ducing materials into both canals of the Fallopian tubes of
a female, it is understood that various changes in the structure
and method may be made by those skilled in the art without
departing from the spirit of the invention.
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