U.S. patent number 3,887,112 [Application Number 05/361,418] was granted by the patent office on 1975-06-03 for apparatus for puncturing and collapsing a container.
This patent grant is currently assigned to Population Research Incorporated. Invention is credited to Lee R. Bolduc, Eugene A. Dickhudt.
United States Patent |
3,887,112 |
Bolduc , et al. |
June 3, 1975 |
Apparatus for puncturing and collapsing a container
Abstract
A dispensing intrauterine catheter and method for injecting
fluid, as a drug material or a tissue adhesive, into the canals of
the Fallopian tubes of a female primate. The catheter has an
elongated tubular member carrying an expandable sleeve member on
its outer end. A dispensing unit attached to the tubular member has
three chambers for storing containers housing drug materials and
fluid to expand the sleeve member. The containers have collapsible
bodies which are pierced by needles which carry the first fluid to
expand the sleeve member. The fluids in the second and third
containers are sequentially dispensed from the outer end of the
tubular member into the uterine cavity. A hand-operated member is
sequentially moved to dispense the fluid from the first container
to expand the sleeve member and then sequentially dispense the
second fluid and third fluid into the uterine cavity. The drug
material is stored in a metal collapsible container. The actuator
has a pair of legs which cooperate with inclined walls to move the
container into piercing engagement with the needle and compress and
collapse the container and thereby move the drug material from the
container via the needle into the uterine cavity.
Inventors: |
Bolduc; Lee R. (Minneapolis,
MN), Dickhudt; Eugene A. (St. Paul, MN) |
Assignee: |
Population Research
Incorporated (Fridley, MN)
|
Family
ID: |
23421967 |
Appl.
No.: |
05/361,418 |
Filed: |
May 18, 1973 |
Current U.S.
Class: |
222/85; 222/82;
222/103 |
Current CPC
Class: |
A61F
6/225 (20130101); A61M 31/00 (20130101) |
Current International
Class: |
A61F
6/00 (20060101); A61F 6/22 (20060101); A61M
31/00 (20060101); B67b 007/26 () |
Field of
Search: |
;222/95,5,103,85,83,82,92 ;128/218P,224,234,235 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Tollberg; Stanley H.
Assistant Examiner: Stack, Jr.; Norman L.
Claims
The embodiments of the invention in which an exclusive property or
privilege is claimed are defined as follows:
1. An apparatus for sequentially dispensing a first fluid, a second
fluid, and a third fluid comprising: a housing having a first
chamber, a second chamber, and a third chamber, first container
means storing the first fluid located in the first chamber, second
container means storing the second fluid located in the second
chamber, third container means storing the third fluid located in
the third chamber, first needle means operable to puncture the
first container means, second needle means operable to puncture the
second container means, third needle means operable to puncture the
third container means, means having a passage for receiving a first
fluid from the first container means, a second passage for
receiving the second fluid from the second container means, and a
third passage for receiving the third fluid from the third
container means, first movable means operable to cause the first
needle means to pierce a portion of the first container means
whereby the first fluid flows from the first container means to the
first passage, second movable means operable to cause the second
needle means to pierce the second container means whereby the
second fluid from the second container means flows to the second
passage, third movable means operable to cause the third needle
means to pierce the third container means whereby the third fluid
from the third container means flows to the third passage, actuator
means operable to sequentially move the first movable means, the
second movable means, and the third movable means whereby the first
fluid, second fluid, and third fluid are sequentially dispensed
into the first passage, second passage, and third passage,
respectively.
2. The apparatus of claim 1 including: first lock means for holding
the first movable means in the fluid dispense position.
3. The apparatus of claim 1 including: second lock means for
holding the second movable means in the fluid dispense
position.
4. The apparatus of claim 1 wherein: the actuator means has a
member located in a first position to engage the first movable
means, located in a second position to engage the second movable
means, and located in a third position to engage the third movable
means.
5. The apparatus of claim 1 including: lock means for holding the
first moveable means in the dispense position, said actuator means
having a member held in a first position when the first moveable
means is held in the dispense position, said member being held in
the second position by the second moveable means wherein the member
is engageable with the second moveable means, said member being
held in the first position by the first moveable means until the
first moveable means is locked.
6. The apparatus of claim 1 wherein: the actuator means includes a
lever carrying a movable member, said movable member operable to
engage the first, second and third movable means.
7. The apparatus of claim 1 including: biasing means located in the
second chamber for holding the second container spaced from the
second needle means.
8. The apparatus of claim 1 including: first lock means holding the
first moveable means in the fluid dispensed position, second lock
means for holding the second moveable means in the fluid dispensed
position, and third lock means for holding the third moveable means
in the fluid dispensed position.
9. The apparatus of claim 1 wherein: the housing has spaced walls
on opposite sides of the second chamber, said second needle means
projected into the forward end of the second chamber and adapted to
pierce the second container means on movement of the second
container means toward the second needle means, said second
moveable means having a pair of spaced legs engageable with
separate parts of the second container means whereby on movement of
the second moveable means into the second chamber the legs move the
second container means onto the second needle means and compress
the second container means to force the second fluid from the
second container means into the second passage.
10. The apparatus of claim 9 wherein: said pair of spaced legs are
joined to an actuator member.
11. The apparatus of claim 9 wherein: said pair of spaced legs each
have a generally rectangular shape and are laterally spaced from
each other.
12. The apparatus of claim 9 wherein: said pair of spaced legs each
having convex faces adapted to engage separate parts of the second
container means.
13. The apparatus of claim 9 wherein: said second container means
is a flexible metal tubular member having a head end facing the
second needle means.
14. The apparatus of claim 9 wherein: the spaced walls of the
housing have portions facing the second chamber, said portions
being tapered inwardly toward the second needle means, one of said
legs being engaged with the other tapered portion, whereby on
movement of said legs into said second chamber said tapered
portions force the legs toward each other and thereby compress the
second container to force the second fluid from the second
container means into the second passage.
15. The apparatus of claim 9 wherein: said second actuator means
includes a lever operable to move the second moveable means into
the second chamber.
16. The apparatus of claim 9 including: lock means for holding the
second moveable means in a forward position wherein the second
fluid has been dispensed from the second container means.
17. Apparatus for dispensing fluid from a collapsible container
storing a fluid comprising: body means having spaced walls and a
chamber between said walls for accommodating the container, needle
means projected into the forward end of the chamber adapted to
pierce the container on movement of the container into engagement
with the needle means, said walls having inside surfaces facing the
chamber, said surfaces being angularly disposed relative to each
other and tapered inwardly toward the needle means, and actuator
means having moveable leg means engageable with said surfaces of
the walls and separate opposite parts of the container whereby on
movement of the actuator means in a dispensing direction the leg
means moves the container into engagement with the needle means
whereby the needle means pierces the container and compresses the
container to force the fluid in the container through the needle
means.
18. The apparatus of claim 17 wherein: the container is a flexible
metal tubular member having a head end facing the needle means.
19. The apparatus of claim 17 wherein: the body means has an end
wall closing one end of a chamber, said needle means being mounted
on said end wall.
20. The apparatus of claim 17 including: biasing means for holding
the container spaced from the needle means.
21. The apparatus of claim 17 wherein: the body means has an end
wall closing one end of the chamber and an open end, said tapered
surfaces of the walls being located forwardly of the open end and
spaced from the end wall, said needle means being mounted on said
end wall.
22. The apparatus of claim 17 wherein: the leg means comprise first
leg means engageable with the surface of one wall and the container
and second leg means engageable with the surface of another wall
and the container said first leg means and second leg means being
moveable toward each other on movement of the actuator means in the
dispensing direction.
23. The apparatus of claim 22 wherein: the first leg means and
second leg means are a bifurcated member joined to an actuator
member.
24. The apparatus of claim 22 wherein: the first leg means and
second leg means are generally rectangular members laterally spaced
from each other.
25. The apparatus of claim 22 wherein: the first leg means and
second leg means each have convex faces adapted to engage the
container.
26. Apparatus for dispensing fluid from a collapsible container
storing a fluid, said container having an end adapted to be opened
whereby the fluid can be dispensed from the container comprising:
body means having spaced walls and a chamber having a foward end,
said chamber located between said walls for accommodating the
container, said walls having inside surfaces facing the chamber,
said surfaces being angularly disposed relative to each other and
tapered inwardly toward the forward end of the chamber, and
actuator means having moveable leg means engageable with said
surfaces of walls and separate opposite parts of the container
whereby on movement of the actuator means in a dispensing direction
the leg means move the container into the chamber and compress the
container to force fluid from the container.
27. The apparatus of claim 26 wherein: the container is a flexible
metal tubular member having a head end at the forward end of the
chamber.
28. The apparatus of claim 26 including: biasing means located in
the chamber for holding the container spaced from the forward end
of the chamber.
29. The apparatus of claim 26 wherein: the body means has an end
wall closing the foward end of the chamber and an open end, said
tapered surfaces of the walls being located forwardly of the open
end and spaced from the end wall.
30. The apparatus of claim 26 wherein: the leg means comprise:
first leg means engageable with the surface of one wall and the
container and second leg means engageable with the surface of the
other wall and the container, said first leg means and second leg
means being moveable toward each other on movement of the actuator
means in the dispensing direction.
31. The apparatus of claim 30 wherein: the first leg means and
second leg means are generally rectangular members laterally spaced
from each other.
32. The apparatus of claim 30 wherein: first leg means and second
leg means each have convex faces adapted to engage the separate
parts of the container.
Description
BACKGROUND OF THE INVENTION
Liquid tissue adhesives have been developed which polymerize when
applied to moist living tissue. These adhesives have been used for
various surgical procedures. When the tissue adhesive is used, the
cells adjacent the adhesive are damaged and eventually replaced
with a fibrous tissue. Several types of liquid tissue adhesive have
been injected into the uterine cavity with a catheter for the
purpose of occluding the canals of the Fallopian tubes. One type of
dispensing catheter is disclosed in our copending U.S. patent
application Ser. No. 339,911, filed Mar. 9, 1973. The expanded
sleeve on this dispensing catheter is designed to fill the uterine
cavity and engage the top wall of the uterus. The catheter does not
have a positioning means to limit the insertion of the catheter
into the uterine cavity. It is desirable to locate the expanded
sleeve member in a position spaced from the top wall of the uterus
leaving a cavity adjacent the top wall of the uterus for the flow
of the drug materials into the canals of the Fallopian tubes. A
second fluid is used to aid the flow of the first fluid into the
canals and set up or polymerize the first fluid.
SUMMARY OF THE INVENTION
The invention is directed to an intrauterine dispensing catheter
for dispensing fluids, as drugs, into the canals of the Fallopian
tubes of a primate female. The apparatus has a tubular member
carrying an expandable sleeve means for filling a substantial
portion of the uterine cavity. A positioning means mounted on the
tubular member locates the sleeve means in the uterine cavity in a
manner so that the sleeve means is spaced from the top wall or
fundus of the uterus. A dispensing means attached to the tubular
member supplies a first fluid to the sleeve means to expand the
sleeve means and sequentially discharge second and third fluids
into the uterine cavity. The third fluid functions to force the
second fluid out of the uterine cavity into the canals. The third
fluid also acts as a polymerizing fluid which sets up the second
fluid thereby occluding the canals of the Fallopian tubes.
The dispensing unit has a plurality of chambers accommodating
containers for storing the fluid. Needles project into the chambers
and are operable on movement of the containers to pierce the
containers. Separate actuators engageable with the containers
function to move the containers into piercing engagement with the
needles and collapse the containers whereby the fluid is dispensed
into the tubular member and fluid carrying means which deliver the
fluid to the outer end of the tubular member. An actuator is hand
operated to sequentially dispense fluid from the containers whereby
the sleeve means is initially expanded before the second and third
fluids are sequentially discharged into the uterine cavity.
The apparatus for dispensing fluid from the container includes a
body means having spaced converging walls facing a chamber
accommodating the container. Needle means project into the
container and pierce the container on movement of the container
into engagement with the needle means. An actuator having leg means
engageable with the converging walls and container moves the
container into the needle means and compresses and collapses the
container driving the fluid from the container. The container can
be of collapsible metal, as lead or lead alloy, hermetically
storing a fluid, as a tissue adhesive.
The invention includes the method of occluding the canals of the
Fallopian tubes by introducing occluding fluids into the canals.
The method includes the insertion of a catheter having an
expandable sleeve into the uterine cavity through the cervical
opening. The expandable sleeve is located in the uterine cavity in
a position spaced from the top wall or fundus of the uterus thereby
leaving a space between the expandable sleeve and the inside of the
top wall. The sleeve member is expanded with a first fluid under
pressure to hold the sleeve member in engagement with the side
walls of the uterine cavity thereby limiting the space between the
sleeve member and the top wall of the uterus. A second fluid, as a
drug material or tissue adhesive, is dispensed into the uterine
cavity space between the sleeve member and the top wall. The second
fluid moves toward the canals of the Fallopian tubes. This movement
is supplemented with the dispensing of the third fluid into the
uterine cavity space. The third fluid, as water, aids in the
polymerization of the second fluid as well as forcing the second
fluid into the canals of the Fallopian tubes. The sleeve member is
contracted by draining the first fluid. The entire catheter is then
withdrawn from the uterine cavity.
IN THE DRAWINGS
FIG. 1 is a longitudinal sectional view of the genital system of a
female primate with the dispensing catheter of the invention
extended into the uterine cavity;
FIG. 2 is a top sectional view of the dispensing catheter of FIG.
1;
FIG. 3 is a sectional view taken along the line 3--3 of FIG. 2;
FIG. 4 is an enlarged sectional view of a fluid container assembly
used in the dispensing catheter;
FIG. 5 is an enlarged sectional view taken along the line 5--5 of
FIG. 3;
FIG. 6 is a sectional view similar to FIG. 5 showing the movable
member in the second position;
FIG. 7 is a sectional view similar to FIG. 5 showing the movable
member in the third position;
FIG. 8 is an enlarged plan view of the structure for dispensing
fluid from a collapsible container storing a fluid, as shown in
FIGS. 2 and 3;
FIG. 9 is a view similar to FIG. 8 showing the container partially
collapsed; and
FIG. 10 is a view similar to FIG. 8 showing the container fully
collapsed.
Referring to the drawings, there is shown in FIG. 1 a diagrammatic
female primate genital system indicated generally at 20. An
intrauterine catheter indicated generally at 21 is located in the
genital system to direct a fluid, as drugs, tissue adhesive, water,
contraceptive gel, or other materials, into the canals of the
Fallopian tubes. The tissue adhesive can be isobutyl
2-cyonoacrylate monomer, silver nitrate or quinacrine materials.
The cyonoacrylate monomer is a liquid plastic which sets up or
polymerizes in response to moisture when placed in the canals of
the Fallopian tubes and thereby functions to occlude the canals.
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 22 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 generally flattened and
triangular in shape. The size and shape of the uterine cavity
varies from female to female. The top of uterus 26 or fundus 28 is
joined to the uterus body 29. The lower end of the body 29 contains
the cervix 31 which separates the vagina 22 from the 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 33 and 34 are
paired, trumpet-shaped, muscular tubular members which extend from
the superior angles of the uterine cavity 27 to the ovaries (not
shown). The ovaries are solid, slightly irregular shaped bodies
situated on either side of the uterus 26 behind and below the
Fallopian tubes 33 and 34.
Fallopian tubes 33 and 34 each have a canal or aqueduct 36 and 37
respectively. The Fallopian tubes 33 and 34 are musculo-membranous
structures about 12 cm in length. They are commonly divided into an
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. The occluding of the canals 36 and 37 with the
drug material according to the invention does not interfere with
the erectile action and movement of the Fallopian tubes
Dispensing apparatus 21 has an elongated tubular member or catheter
38 having a length sufficient to extend through the vagina 22 and
into the uterine cavity 27. An expandable sleeve member 39 as a
flexible balloon or the like, is secured to the upper end of tube
38 with bands 40A and 40B. Band 40A holds the outer end of sleeve
member 39 in sealing engagement with the terminal end of tube 38.
Band 40B secures the inner end of sleeve member 39 to the tube 38.
Sleeve member 39 is a flexible elastic cylindrical sheet made of
relaxed rubber material. The rubber material has uniform surface
tension and uniform expansion characteristics. Member 39 can be
expanded into uniform and firm engagement with a major portion of
the inner wall of the uterus regardless of the size or shape of the
uterine cavity. This enables the same sleeve member 39 to be used
on all types of primate females.
The sleeve member 39 defines a cavity or chamber 41. A plurality of
holes 42 provide the passages from chamber 41 into the passage of
the tube 38 whereby fluid in the tube 38 can flow through the holes
42 to the chamber 41 to increase the size of sleeve member 39. The
end of tube 38 is closed with a plug 43. A pair of small tubes 44
and 46 extend longitudinally through tube 38 and are attached to
the plug 43. Tube 44 has an open end 44A projected through plug 43.
In a similar manner, tube 46 has an end 46A projected through plug
43 whereby fluid can flow through the tubes 44 and 46 into the
uterine cavity 27. End 46A of tube 46 is tapered or pinched
together to close the end of passage or tube 46. This prohibits the
flow of fluid from uterine cavity 27 into tube 46.
Secured to a mid-portion of tube 38 is an annular collar or stop
member 47. As shown in FIG. 1, stop member 47 engages or abuts
against the cervix 31 to limit the insertion of the sleeve member
39 into the uterine cavity 27. The stop member 47 maintains the end
of the tubular catheter 38 spaced from the top wall or fundus 28 of
the uterus. The sleeve member 39 when expanded fills the major and
lower portion of the uterine cavity 27 leaving a small chamber or
space 27A at the upper end of the uterine cavity in communication
with the canals 36 and 37 of the Fallopian tubes 33 and 34. The
expanded sleeve member 39 forces the catheter up into the uterine
cavity 27. The stop 47 prevents inward movement of the sleeve
member 39 and holds sleeve member 39 in firm and continuous
engagement with the inner wall of the uterus. Chamber 27A provides
for the free flow of fluids which are dispensed into the uterine
cavity 27 to the canals 36 and 37 of the Fallopian tubes 33 and
34.
As shown in FIGS. 1 and 2, the outer end of the tubular catheter 38
is attached to a dispensing unit, indicated generally at 48. The
dispensing unit 48 is operable to initially discharge a first
fluid, as air or water, into tube 38 to expand the sleeve member
39. A second fluid, as drug materials, is then discharged via tube
44 into the upper end of the uterine cavity 27. The third actuation
of the dispensing unit discharges a third fluid, as water, via the
tube 46 into the upper end of the uterine cavity 27. The third
fluid functions to promote the flow of the first fluid into the
canals of the Fallopian tubes and set up a reaction which promotes
the change of the second fluid into a solid in the canals 36 and 37
of the Fallopian tubes and thereby block the canals.
Referring to FIG. 2, dispensing unit 48 has a body or housing 49
having three chambers 51, 52 and 53. The chambers 51, 52 and 53 are
located in side-by-side relationship, extending in a longitudinal
direction, and are in a common horizontal plane. The chambers 51,
52 and 53 can be located in a common vertical plane whereby the
chambers are positioned over each other. A first passage 54 in body
49 connects chamber 51 in the passage within tube 38. A second
passage 56 connects the chamber 53 with the tube 46. The tube 44
extends through the inner end wall of tube 38 and into chamber
52.
A first container or ampulla 57 containing a fluid, as water or
air, is located in chamber 51. A second container or ampulla 58 is
located in chamber 52. The third container or ampulla 59 is located
in chamber 53. Containers 57 and 59 are identical in structure, as
shown in detail in FIG. 4. Other containers as disclosed in U.S.
application Ser. No. 339,911, can be used in the chambers. The
disclosure of application Ser. No. 339,911 is incorporated herein
for the details of the containers for storing the fluids.
A first tubular needle 63 is attached to a support or disc 64
located in the base of chamber 51. The needle 63 is in alignment
with the center of the forward end of container 57. The end of tube
44 projected into chamber 52 comprises a tubular needle 62 in
alignment with the forward end of container 58. Needle 62 is
attached to a circular disc or support 66 located in the base of
chamber 52. A third tubular needle 63 projects into chamber 53.
Needle 63 is mounted on a disc or support 67 located in the base of
chamber 53.
Container 57, as shown in FIG. 4, has a cylinder 68 for storing
fluid 69, as drugs, water, air, or the like. The forward end of
cylinder 68 has a head 71 having a central passage closed with a
resilient plug 72. The open end of cylinder 68 is closed with a
plunger assembly 73 carrying a piston 74. The rear portion of
plunger assembly 73 has an outwardly directed annular flange 76.
The flange 76 functions as a stop or bearing member for a
compression spring 77. The forward or opposite end of spring 77 is
in engagement with an annular seat 78 on the outer wall of cylinder
68. Spring 77 biases the plunger assembly 73 in an outward
direction or out of cylinder 68. The plunger assembly 73 has a
central longitudinal bore 79 slidably accommodating an actuator rod
81. Actuator 81 has an axial bore 82 open to the bore 79 and
accommodating a compression spring 83. Spring 83 provides a
yieldable link between rod 81 and plunger assembly 73.
Movably disposed in body 49 is a first actuator 84 engageable with
the outer end of rod 81. Actuator 84 is movable in a forward
direction, as indicated by arrow 86, to move the rod 81 into the
cylinder 68. On movement of the actuator 84 in a forward direction,
springs 77 and 83 will be initially compressed supplying a uniform
pressure on piston 74. The entire cylinder 68 will move in a
forward direction until the needle 61 pierces the plug 72 thereby
providing fluid communication between the container 57 and the
passage 54. Continued movement of the plunger assembly 73 in a
forward direction will drive the piston 74 toward the plug 72,
thereby dispensing the fluid 69 via needle 62 and passage 54 into
the catheter tube 38 to expand the sleeve 39. Sleeve member 39 will
expand with a uniform pressure so as to fill the lower area of the
uterine cavity and exert uniform pressure on the inside wall of the
cavity. Piston 74 is moved into sealing engagement with the needle
61 to trap the fluid in the tube 38 and chamber 41 thereby insuring
substantially constant fluid pressure in chamber 41.
The container 59 is actuated in a manner similar to container 57 on
movement of an actuator 87. Located between actuators 84 and 87 is
a central actuator 88 operable on movement in a forward direction
to dispense fluid from the container 58 into the tube 44. Tube 44
carries the fluid to the center portion of the uterine cavity space
27A.
The actuators 84, 87 and 88 are sequentially moved on operation of
a trigger assembly, indicated generally at 89. Trigger assembly 89
is mounted on the rear portion of housing 49 adjacent the rear ends
of the actuators 84, 87 and 88. Trigger assembly 89 has a
downwardly directed lever or trigger member 91. The mid-portion of
lever 91 has a hole accommodating a transverse pivot pin 92. Pivot
pin 92 is anchored in a downwardly extended handle or pistol grip
93 attached to the rear portion of body 49 and extended downwardly
therefrom. Lever 91 has an upper transverse head 94 located in
alignment with the ends of actuators 84, 87 and 88. Springs 96
engageable with body 49 and the upper end of lever 91 bias the
lever in a rearward or cocked position, as shown in FIG. 3.
Head 94 has a first longitudinal passage 97 in alignment with
actuator 88 and a second longitudinal passage 98 in alignment with
actuator 87. A transverse bore 99 opens to passages 97 and 98. Bore
99 has a forward opening to provide access of the actuators 87 and
88 to the passages 98 and 97, respectively. Slidably disposed in
bore 99 is a movable pin or member 101. As shown in FIG. 5, pin 101
has a reduced diameter neck 102 attached to an enlarged head 103. A
compression spring 104 engages head 103 and a plug 106 closing the
end of bore 99. Spring 104 biases the pin 101 along the bore 99
away from plug 106. First actuator 84 has a rearwardly directed
finger 107 engageable with the head 103 to hold the pin 101 in the
first or cocked position, as shown in FIG. 5. When pin 101 is in
the cocked position, it does not provide a driving link or
interfere with the actuators 87 and 88.
Returning to FIG. 2, actuator 84 has a notch or slot 109. Similar
notches or slots 111 and 112 are located in actuators 88 and 87,
respectively. As shown in FIG. 3, a lock mechanism, indicated
generally at 113, cooperates with the slot 111 to hold the actuator
88 in the "in" or fully dispensed position. Lock 113 comprises a
movable pin 114 having a head 116 located above body 49 so that it
can be gripped to release the lock. The forward portion of the pin
114 carries a C-ring or clamp ring 117 providing a stop for a
spring 118. Spring 118 is located concentrically around pin 114 and
engages an inner portion of body 49 to bias the pin 114 into
engagement with actuator 88. When actuator 88 is moved to the in
position, pin 114 will be biased by spring 118 into the slot 111
thereby holding the actuator 88 in the in position until the lock
113 has been released. Referring to FIG. 1, identical locks 119 and
121 cooperate with the actuators 84 and 87 to lock the actuators in
the in position.
Referring to FIG. 6, the trigger 91 has been actuated to move the
actuator 84 to the in position. Lock 119 holds the actuator 84 in
the in position. When the trigger 91 is returned to the top
position by the spring 96, the pin 101 will move to its second
position in engagement with the finger 108 behind the actuator 88.
Finger 108 prevents the pin from moving to the bottom of the bore
99. The trigger 91 is then actuated to dispense the fluid from
container 58 into the uterine cavity via the tube 44. Lock 113 will
hold the actuator 88 in the in position. The trigger 91 is again
moved back to the cocked position by the springs 96. The pin 101,
as shown in FIG. 7, is moved by spring 104 to the bottom of bore 99
adjacent the end of actuator 87. The third actuation of the trigger
91 will move actuator 87 to dispense fluid from container 59 via
the tube 46 into the uterine cavity. Lock 121 will move into slot
112 to hold the actuator 87 in the in position. Lock 119 is
released by raising head 116. The spring 77 will expand container
57 whereby fluid will drain from chamber 41. This collapses sleeve
member 39 enabling the catheter to be withdrawn from the uterine
cavity.
Referring to FIGS. 2, 8, 9 and 10, container or ampulla 58
comprises an elongated tubular member having a flexible wall of
metal, preferably lead, lead alloy or other material that is liquid
impervious. The container 58 stores moisture-sensitive drugs, as
tissue adhesives and the like. It is essential that the containers
be made of material which prevents the fluids from coming into
contact with moisture or other substances which set up these
materials. Container 58 has a cylindrical head 122 closed with an
end wall or diaphragm 123. The head 122 is integral with a
cylindrical and tapering body 124. The body 124 has a closed
transverse end 126. The container 58 is located in chamber 52 with
the head 122 in the forward and small end of the chamber 52
adjacent the needle 62. Body 124 has facing side walls 127 and 128
forming part of the mid-section of chamber 52. Side walls 127 and
128 are angularly disposed relative to each other and taper
inwardly in a foward direction toward needle 62. Spring 129
interposed in the small foward end of the chamber between the head
122 and the bottom of chamber 52 holds the wall 123 spaced from the
end of needle 62.
Actuator 88 has a forward end separated or bifurcated into two
spaced members or legs 131 and 132. As shown in FIG. 3, legs 131
and 132 are generally flat and rectangular shaped and are located
in the outer end of chamber 52. The legs have convex inner faces
133 and 134 disposed adjacent the body 124.
On movement of the actuator 88 in the forward or inward direction,
as indicated by arrow 136 in FIGS. 8-10, the legs 131 and 132 move
into chamber 52 and ride on the inclined or tapered side walls 127
and 128. The side walls 127 and 128 force the legs 131 and 132
toward each other into squeezing engagement with the body 124. The
legs 131 and 132 force the container 58 against the spring 129 into
the needle 62. As shown in FIG. 9, the container 58 has been driven
into needle 62 providing a passage for the fluid in container 58 to
the tube 44. Continued movement of the actuator 88 in the forward
direction collapses the container 58 and transversely squeezes the
container whereby the fluid in the container is forced through
needle 62 into the tube 44. Tube 44 carries the fluid into the
uterine cavity, as shown in FIG. 1.
The actuators 84, 88 and 87 can be spring biased as disclosed in
FIGS. 20 to 25 of our application Ser. No. 339,911. The disclosure
of this structure of application Ser. No. 339,911 is hereby
incorporated by reference in this application. Alternatively, the
actuators 84, 88 and 87 can be selectively moved with longitudinal
rod members, as disclosed in our application Ser. No. 369,710 for
Dispensing Instrument. The disclosure of this structure is
incorporated by reference in this application.
In use, a dispensing catheter 21 performs a method of introducing a
material, as a drug, tissue adhesive, contraceptive gel, and like
materials, into the canals 36 and 37 of the Fallopian tubes 33 and
34, respectively. The method includes the introduction of an
elongated catheter 21 having an expandable sleeve member 39 at the
forward end thereof through the cervical opening into the uterine
cavity 27. The sleeve member 39 is located in the uterine cavity 27
in a position whereby the top end of the sleeve member is spaced
from the top wall 28 of the uterus leaving a small chamber 27A. A
stop 47 engages the exterior end of the cervix 31 to prohibit
further insertion of the catheter into the uterine cavity. The
sleeve member 39 is expanded with a first fluid, as water, under
pressure to fill the major portion of the uterine cavity 27. The
expanded sleeve member 39 functions as a plug or sealing member as
it is in uniform and continuous engagement with the inner wall of
the uterine cavity. The expanded sleeve member tends to move the
catheter 21 further into the uterine cavity. The stop 47 prevents
this movement and cooperates with the sleeve member to insure a
uniform and firm engagement of the sleeve member 39 with the inner
wall of the uterine cavity 21.
The dispensing unit 21 is actuated by pulling the trigger 91. The
actuator 88 is moved in a foward direction forcing the container 58
into piercing engagement with needle 62 and collapsing the
container, thereby driving the second fluid, as tissue adhesive and
the like, from the container 58 via tube 44 into the center area of
chamber 27A of the uterine cavity 27. The second fluid from
container 57 being under pressure will flow into the canals 36 and
37 open to the uterine cavity 27. The second fluid will continue to
flow until the actuator is locked in the in position by the lock
means 113. The dispensing unit is then actuated for a third time by
moving the trigger 91. This will move actuator 87 in a forward
direction dispensing the third fluid from container 59 via tube 46
into the uterine cavity. The third fluid, as water, will transport
and force the second fluid into the canals 36 and 37. The third
fluid will also aid the setting up or polymerization of the second
fluid, thereby occluding the canals. Any second fluid remaining in
the uterine cavity 27 will be completely polymerized and will not
adhere to the uterine wall. This material will be removed from the
uterine cavity during the normal discharge therefrom.
The lock mechanism 119 is released whereby the first fluid in
chamber 41 is withdrawn via the tube passage 38 into the container
57. This contracts the sleeve member 39 enabling the catheter to be
withdrawn from the uterine cavity 27.
While there have been shown and described a preferred embodiment of
the dispensing catheter and fluid container, as well as the method
of introducing material into the canals of the Fallopian tubes, it
is understood that variations and changes in the structures and
methods may be made by those skilled in the art without departing
from the spirit of the invention. The invention is defined in the
following claims.
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