U.S. patent number 3,871,374 [Application Number 05/394,727] was granted by the patent office on 1975-03-18 for dispensing instrument.
This patent grant is currently assigned to Population Research Incorporated. Invention is credited to Lee R. Bolduc, Eugene A. Dickhudt.
United States Patent |
3,871,374 |
Bolduc , et al. |
March 18, 1975 |
DISPENSING INSTRUMENT
Abstract
A fluid dispensing instrument and method for introducing a
fluid, as a drug material, into the canals of the Fallopian tubes
of a primate female. The dispensing instrument has a tubular member
carrying an expandable balloon assembly. The balloon assembly has a
sleeve member which is initially expanded by operating an actuator
assembly to substantially displace the entire uterine cavity and
moniter the integrity of the walls of the uterus. The sleeve member
is partially contracted by releasing the actuator assembly. A
control mechanism cooperates with the actuator assembly to limit
the fluid pressure on the sleeve member to a perdetermined
pressure. Drug material is introduced into the upper portion of the
uterine cavity above the partially expanded balloon assembly by
operating a plunger which drives a container storing the drug
material onto a needle. The balloon assembly is then fully expanded
by operation of the actuator assembly to force the drug material
from the upper portion of the uterine cavity into the canals of the
Fallopian tubes. The expanding sleeve member forces the drug
material into both canals.
Inventors: |
Bolduc; Lee R. (Minneapolis,
MN), Dickhudt; Eugene A. (St. Paul, MN) |
Assignee: |
Population Research
Incorporated (Minneapolis, MN)
|
Family
ID: |
23560171 |
Appl.
No.: |
05/394,727 |
Filed: |
September 6, 1973 |
Current U.S.
Class: |
128/831 |
Current CPC
Class: |
A61F
6/225 (20130101); A61M 31/00 (20130101); A61M
2210/1425 (20130101) |
Current International
Class: |
A61F
6/00 (20060101); A61F 6/22 (20060101); A61M
31/00 (20060101); A61m 001/00 () |
Field of
Search: |
;128/235,349,234,224,246,127,129,126,1R,216,260,240,241,341,232,2A |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
"The Effect of Methyl Cyonoacrylate Tissue Adhesive on the Human
Fallopian Tube and Endometrium," The Journal of Obstetrics &
Gyn. of The British Comm. November 1972, Vol. 79, pp. 1028-1039.
.
Human Sterilization, Richart et al., 1972, pp. 101-115 and
353-359..
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Yasko; J.
Attorney, Agent or Firm: Schwartz, Esq.; Lew
Claims
The embodiments of the invention in which an exclusive property or
privilege is claimed are defined as follows:
1. An instrument for placing material into both canals of Fallopian
tubes open to a uterine cavity comprising: a ballon assembly having
an expandable sleeve member surrounding a chamber, means supporting
the balloon assembly, dispensing means connected to said means
supporting the balloon assembly operable to expand the sleeve
member and discharge material into the uterine cavity, said
dispensing means including first means fluidly connected to said
chamber to supply fluid under pressure thereto, actuator means
cooperating with said first means to supply a predetermined fluid
pressure to said chamber to expand the sleeve member to fully
displace the uterine cavity, control means cooperating with said
actuator means when said predetermined pressure is attained to stop
further expansion of the sleeve member, said control means allowing
partial contraction of the sleeve member when the actuator means is
released, and second means operable to discharge material into the
uterine cavity, said actuator means operable to re-expand said
sleeve member by subjecting the sleeve member to said predetermined
pressure whereby said material in the uterine cavity is forced into
the canals of the Fallopian tubes by the expanding sleeve
member.
2. The instrument of claim 1 wherein: the first means includes a
cylinder and a piston movable within said cylinder to force fluid
from said cylinder into the chamber, said actuator means engageable
with said piston to move said piston relative to said cylinder.
3. The instrument of claim 1 wherein: the actuator means includes a
first member, a second member movable relative to said first member
from an extended position to a contracted position, said contracted
position being attained when the predetermined fluid pressure is
present in the chamber, biasing means yieldably holding the second
member in its extended position, and lock means engageable with the
control means when the second member is in the contracted
position.
4. The instrument of claim 3 wherein: the control means includes a
movable member having a plurality of spaced fingers selectively
engageable with the lock means, biasing means holding the movable
member in a stop position and allowing movement away from the stop
position on release of the actuator means whereby the sleeve member
is partially contracted.
5. The instrument of claim 4 wherein: the lock means includes a
body having a projection, and biasing means for moving the
projection between adjacent fingers when said predetermined
pressure is attained.
6. The instrument of claim 1 wherein: the sleeve member is made of
expandable tubular sheet material having low surface tension
properties.
7. The instrument of claim 1 wherein: the elongated means is a
tubular member having a passage open to a chamber surrounded by the
sleeve member, said first means being fluidly connected to said
passage, said second means including a tube extended longitudinally
through said passage, said tube having an exit opening means
adjacent the sleeve member, container means carrying the material
connectable to said tube, and means operable to couple the
container means to the tube and drive the material from the
container means through the tube and into the uterine cavity.
8. The instrument of claim 7 wherein: the exit opening means has a
first opening for directing material in one direction in the
uterine cavity and a second opening for directing material in
another direction in the uterine cavity.
9. The instrument of claim 1 wherein: the second means includes a
tube having exit opening means adjacent the sleeve member to direct
material into the uterine cavity, said exit opening means having a
first opening for directing material in one direction and a second
opening for directing material in another direction.
10. An instrument for placing material into both canals of
Fallopian tubes of a uterine cavity comprising: expandable sleeve
means surrounding a chamber for displacing the uterine cavity,
dispenser means connected to said sleeve means operable to expand
the sleeve means and discharge material into the uterine cavity,
said dispenser means including a first means to supply a
predetermined fluid pressure to said chamber to expand the sleeve
means to fully displace the uterine cavity, control means
cooperating with said first means when said predetermined pressure
is attained to stop further expansion of the sleeve means, said
control means allowing partial contraction of the sleeve means when
the first means is released, and second means operable to discharge
material into the uterine cavity, said first means operable to
re-expand said sleeve means by subjecting the sleeve means to said
predetermined pressure whereby said material in the uterine cavity
is forced into the canals of the Fallopian tubes by the expanding
sleeve means.
11. The instrument of claim 10 wherein: said first means includes a
cylinder and a piston movable within said cylinder to force fluid
from said cylinder into the chamber surrounded by the sleeve means,
and actuator means engageable with said piston to move said piston
relative to said cylinder.
12. The instrument of claim 11 wherein: the actuator means includes
a first member, a second member movable relative to the first
member from an extended position to a contracted position, said
contracted position being attained when the predetermined fluid
pressure is present in the chamber, biasing means yieldably holding
the second member in its extended position, and lock means
engageable with the control means when the second member is in the
contracted position.
13. The instrument of claim 12 wherein: the control means includes
a movable member having a plurality of spaced fingers selectively
engageable with the lock means, biasing means holding the movable
member in a stop position and allowing movement away from the stop
position on release of the actuator means whereby the sleeve member
is partially contracted.
14. The instrument of claim 13 wherein: the lock means includes a
body having a projection, and biasing means for moving the
projection between adjacent fingers when said predetermined
pressure is attained.
15. The instrument of claim 10 wherein: the sleeve means is made of
expandable tubular sheet material having low surface tension
properties.
16. An instrument for placing material in both canals of Fallopian
tubes open to the uterine cavity comprising: a balloon assembly
having an expandable sleeve member, first means operable to expand
the sleeve member into engagement with the inside walls of the
uterus to fully displace the uterine cavity and then partially
contract the sleeve member, second means for discharging material
into the uterine cavity between the partially contracted sleeve
member and the inside top wall of the uterus, said first means
being operable to re-expand the sleeve member to fully displace the
uterine cavity whereby the material in the uterine cavity is forced
into the canals of the Fallopian tubes by the re-expanding sleeve
member.
17. The instrument of claim 16 including: elongated tubular means
for supporting the balloon assembly connected to the first means
and the second means.
18. The instrument of claim 16 wherein: the first means includes an
actuator assembly operable to supply predetermined fluid pressure
to a chamber surrounded by the sleeve means, and control means
cooperating with said actuator assembly when said predetermined
pressure is attained to stop further expansion of the sleeve
member, said control means allowing partial contraction of the
sleeve member when the actuator assembly is released.
19. The instrument of claim 18 wherein: the actuator means includes
a first member, a second member movable relative to the first
member from an extended position to a contracted position, said
contracted position being attained when the predetermined fluid
pressure is present in the chamber, biasing means yieldably holding
the second member in its extended position, and lock means
engageable with the control means when the second member is in the
contracted position.
20. The instrument of claim 19 wherein: the control means includes
a movable member having a plurality of spaced fingers selectively
engageable with the lock means, biasing means holding the movable
member in a stop position and allowing movement away from the stop
position on release of the actuator means whereby the sleeve member
is partially contracted.
21. The instrument of claim 20 wherein: the lock means includes a
body having a projection, and biasing means for moving the
projection between adjacent fingers when said predetermined
pressure is attained.
22. The instrument of claim 16 wherein: the sleeve means is made of
expandable tubular sheet material having low surface tension
properties.
23. A method of placing material in both canals of the Fallopian
tubes open to the uterine cavity with an expandable ballon means
comprising: introducing the ballon means into the uterine cavity,
expanding the balloon means to displace substantially the entire
uterine cavity by subjecting the balloon means to a predetermined
fluid pressure to expand the balloon means, partially contracting
the balloon means by reducing the fluid pressure applied to the
balloon means, discharging material into the uterine cavity above
the partially contracted balloon means, re-expanding the partially
contracted balloon assembly to again fully displace the uterine
cavity by subjecting the balloon means to fluid pressure to
displace substantially the entire uterine cavity thereby forcing
the material into the canals of the Fallopian tubes, contracting
the balloon means by reducing the fluid pressure applied thereto,
and removing the contracted balloon means from the uterine
cavity.
24. The method of claim 23 wherein: the balloon means is initially
expanded to fully displace the uterine cavity with a fluid pressure
of approximately 7 psi to 71/2 psi and said balloon means is
partially contracted by reducing the fluid pressure applied thereto
to approximately 21/2 psi to 3 psi.
25. The method of claim 23 wherein: the material is discharged into
the uterine cavity in opposite lateral directions which separates
the material into two portions, said expansion of the partially
contracted balloon means moving said two portions of the material
into the canals of the Fallopian tubes.
26. The method of claim 23 including: preventing an increase in the
predetermined fluid pressure when the predetermined pressure is
attained.
27. The method of claim 23 wherein: the fluid pressure applied to
the balloon means is reduced more than one-half the value of the
predetermined fluid pressure.
28. The method of claim 23 wherein: the balloon means is
re-expanded by subjecting the balloon means to substantially the
same predetermined fluid pressure used to first expand the balloon
means.
Description
BACKGROUND OF THE INVENTION
Bilateral disection of the Fallopian tubes is a common surgical
procedure used to sterilize a female. This procedure involves
severing and tying the Fallopian tubes. Intrauterine devices, as
plugs and wires, are used to temporarily sterilize a female. These
devices include plugs which are inserted into the canals of the
Fallopian tubes to prevent ova from passing into the uterus. Smith
in 1849 described a method of treating sterility by passing whale
bone splints into the canals. These devices do not insure that the
ova cannot flow through the canals into the uterus. The devices can
be dislodged and lost without the female being aware of it. There
is no assurance that the devices are effective. Climber in U.S.
Pat. Nos. 3,675,693 and 3,680,245 discloses plugs attached to the
uterine wall to block the entrance of ova into the uterus from the
Fallopian canals and the exit of sperm from the uterine cavity into
the Fallopian canals. These plugs are designed to effect temporary
sterilization in that they can be removed and do not permanently
block the canals of the Fallopian tubes. Plug contraceptive devices
are not entirely effective in that it is possible for ova to
by-pass the plugs and enter the uterus.
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 adhesives are used,
the cells adjacent the tissue are damaged and eventually replaced
with a fibrous tissue. A liquid tissue adhesive has been injected
into the uterine cavity with a catheter to occlude the canals of
the Fallopian tubes. Studies have been conducted into silver
nitrate, zinc chloride and methyl cyanoacrylate to occlude the
canals of the Fallopian tubes. These materials have been introduced
into the uterine cavity with balloon catheters in an effort to
place the materials in the canals of the Fallopian tubes. These
catheters are not designed to accommodate the different sizes,
shapes and characteristics of uteri and do not insure that the
materials are placed in each canaal of the Fallopian tubes. Also,
these catheters may direct all of the material into one canal so
that the material is forced through the canal into the body
cavity.
SUMMARY OF THE INVENTION
The invention is directed to an instrument and method for
monitering the integrity of the uterus and for dispensing a fluid,
as a drug material, into both canals of the Fallopian tubes of a
female. More specifically, the invention is directed to an
instrument for introducing a predetermined minimum amount of tissue
adhesive into both canals of the Fallopian tubes. The instrument
has an elongated tubular member having a forward end attached to an
expandable balloon assembly. A dispenser connected to the tubular
member operates to initially expand the balloon assembly to
displace substantially the entire uterine cavity.
The ballon assembly has a soft, relaxed sleeve member that is
expanded to a predetermined pressure to substantially fully
displace the uterine cavity. The pressure within the chamber
surrounded by the sleeve member will not be attained if the walls
of the uterus are weak, diseased or ruptured or if there is a leak
in the fluid system for the sleeve member. The expanded sleeve
assembly checks the integrity of the uterus independently of the
size of the uterine cavity. A dispenser having an actuator assembly
is operable to supply fluid under pressure to the chamber within
the sleeve member. When a predetermined fluid pressure is attained,
the actuator assembly is locked into a control mechanism which
prevents further movement of the actuator assembly to build up
additional fluid pressure in the chamber. The predetermined
pressure is the maximum fluid pressure applied to the sleeve member
thereby minimizing over-expansion of the uterus. When the force
applied by the operator on the actuator assembly is released, the
fluid pressure acting on the sleeve member is relieved whereby the
sleeve member contracts or reduces in size but still maintains a
low pressure seal with the inner wall of the lower part of the
uterus.
The dispenser has a plunger for forcing drug material from a
container into the uterine cavity above the partially expanded
sleeve member. The actuator assembly is then operated to reexpand
the sleeve member to displace the space of the uterine cavity. This
expansion of the sleeve member forces the drug material in the
uterine cavity into the separate canals of the Fallopian tubes.
Substantially all of the drug material introduced into the uterine
cavity is moved into the canals of the Fallopian tubes on expansion
of the sleeve member. When a tissue adhesive is placed into the
canals it reacts with the moisture in the tissue of the Fallopian
tubes to polymerize the adhesive and thereby occlude the canals.
The tissue adhesive is eventually replaced with scar tissue which
permanently occludes the canals. The sleeve member is contracted
whereby it can be readily removed from the uterine cavity.
An object of the invention is to provide an instrument and method
of introducing a predetermined minimum amount of drug material into
both canals of the Fallopian tubes from the uterine cavity. A
further object of the invention is to provide an instrument for and
method of monitoring the integrity of the walls of the uterus and
fluid pressure system of the instrument before the material is
introduced into the uterine cavity. Another object of the invention
is to provide a method and instrument for introducing a controlled
amount of drug material into the canals of the Fallopian tubes
under low pressure, whereby the drug material does not flow through
the Fallopian tubes into the body cavity. A still further object of
the invention is to provide a method and instrument for introducing
drug material into the canals of the Fallopian tubes which places a
minimum amount of force on the walls of the uterus and which can
accommodate different sizes, shapes and characteristics of uteri.
Yet another object of the invention is to provide a method and
instrument for introducing a material into both canals of the
Fallopian tubes which is not position sensitive and does not apply
substantial pressures to the material whereby the material is not
forced into the blood stream.
IN THE DRAWINGS
FIG. 1 is a sectional view of the reproductive system of a female
accommodating a dispensing instrument to practice the method of the
invention of locating drug material in both canals of the Fallopian
tubes;
FIG. 2 is a sectional view of the uterus of FIG. 1 showing the
sleeve member in a partially expanded position;
FIG. 3 is a sectional view similar to FIG. 2 showing the expansion
of the sleeve member to force the drug material into both canals of
the Fallopian tubes;
FIG. 4 is a top plan view of the dispenser with the top section or
cover removed showing the actuator assembly and plunger in the
inoperative position;
FIG. 5 is a view similar to FIG. 4 showing the actuator assembly in
the position to fully expand the sleeve member and locked into the
control mechanism;
FIG. 6 is a view similar to FIG. 4 showing the actuator assembly in
the position to partially expand the sleeve member and the plunger
in the drug material dispensed position;
FIG. 7 is a view similar to FIG. 4 showing the actuator assembly in
the position to fully expand the sleeve member;
FIG. 8 is an enlarged sectional view taken along the line 8--8 of
FIG. 1;
FIG. 9 is a side elevational view, partly sectioned, of the
actuator assembly;
FIG. 10 is a longitudinal sectional view of the actuator
assembly;
FIG. 11 is an enlarged sectional view taken along the line 11--11
of FIG. 9; and
FIG. 12 is an enlarged sectional view taken along the line 12--12
of FIG. 7 .
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring to the drawing, there is shown in FIG. 1 a dispensing
instrument indicated generally at 20 in operative relation with a
female reproductive system, indicated generally at 21. Reproductive
system 21 has a uterus 22 joined to a pair of Fallopian tubes 23
and 24. The lower part of uterus 22 is integral with an elongated
vagina 26. Vagina 26 has a cavity 27 having an opening or entrance
28. The opposite end of vaginal cavity 27 is in communication with
a cervix 29. Cervix 29 has an opening 31 providing a passage from
the vaginal cavity 27 to the uterine cavity 32. Fallopian tubes 23
open or exit to opposite sides of the upper part of the uterine
cavity 32.
Uterus 22 is a generally pear-shaped, thick walled, hollow organ
situated between the bladder and rectum. The uteri of female
primates vary in size and shape. Wall thicknesses, strength and
sensitivity to pain vary from female to female. The inner wall of
the uterus may contain lymph nodes and vary in size and
configuration. The uterine cavities also vary in size and shape.
Some uteri have strong walls while others have weak and relatively
elastic walls. Diseased uteri generally have weak walls. The
uterine cavity 32 is generally flattened and triangular in shape.
The uterine cavity may have other shapes.
Fallopian tubes 23 and 24 are paired, trumpet-shaped, muscular
linear members which extend from the superior angle of the uterine
cavity 32 to the ovaries (not shown). Fallopian tubes of an adult
female are musculo-membranous structures about 12 cm. in length.
The outlet of the canals of the Fallopian tubes can vary in
position relative to the uterine cavity. For example, the outlets
can be symmetrically opposite each other, as shown in FIG. 1 of the
drawing, or can be relatively close to each other. Also, the size
of the canals 33 and 34 varies from female to female.
Fallopian tubes are commonly divided into isthmus, intramural and
ampullary sections. Canals 33 and 34 provide passages for the
movement of ova from the ovaries to the uterine cavity 32. The
intramural sections of the Fallopian tubes traverse the uterine
wall in more or less straight fashion. It has an ampulla-like
dilation just before it communicates with the uterine cavity. The
walls of the Fallopian tubes consist of three layers; the serosal
layer, the muscular layer and the mucosal lining. The muscular
layer includes longitudinal muscle fibers which, when contracted,
bring the outer ends of the Fallopian tubes into close contact with
the surfaces of the ovaries. Blood vessels are abundant in the
muscular layers where they form with the muscular bundles a kind of
erectile tissue which, if engorged with blood, move the Fallopian
tubes to sweep over the surfaces of the ovaries. This movement of
the Fallopian tubes is impaired when the tubes are severed and
tied. The occluding of the canals 33 and 34 with drug material
according to the invention does not interfere with the erectile
action and movement of the Fallopian tubes relative to the
ovaries.
Uterus 22 has a top wall or fundus 36 and side walls 37 and 38
surrounding uterine cavity 32. The inside of the top wall 36 and
the inside of the side walls 37 and 38 have an inside lining or
membrane 39 which is periodically sloughed off in the normal cycle
of the female.
Dispensing instrument 20 has an elongated probe or tubular member
41. Member 41 has a passage 42 and a length sufficient to pass
through the vaginal cavity 27 and into the uterine cavity 32. A
balloon assembly indicated generally at 43 is mountd on the upper
or outer end of the tubular member 41. The balloon assembly has a
sleeve member 44. The upper or outer end of sleeve member 44 is
attached to tubular member 41 with an annular fastener 46, as a
collar or threads. A similar annular fastener 47 secures the inner
end of the sleeve member 44 around the tubular member 41 forming
therewith a chamber 48. A plurality of openings 45 in the tubular
member 41 provide passages between the passageway 42 of the tubular
member 41 and the chamber 48.
Sleeve member 44 is a tubular sheet member of soft and relaxed
flexible and elastic material, as rubber or plastic, which expands
with a minimum of surface tension. For example, thin latex rubber
having low surface tension, whereby the rubber uniformly expands
with a relatively low pressure, is suitable material for sleeve
member 44. The material of sleeve member 44 readily expands to
displace the uterine cavity 32 by conforming to the shape of the
cavity without applying extreme pressure to localized portions of
the uterus wall. When the cavity 32 is fully displaced with the
sleeve member 44, as shown in FIG. 1, sleeve member 44 is in
uniform surface engagement with the inside wall 39. Conventional
balloon catheters, being of hard, relatively non-elastic material,
do not assume the configuration of the uterine cavity when expanded
under low pressure.
The upper or outer end of probe 41 is closed with a head 49. Head
49 has a transverse passage 50 having diametrically opposite open
discharge ends 51 and 52. The head 49 is secured to an elongated
tube 53 extended concentrically through the tubular member 41.
Tubular member 41 is attached to a dispenser indicated generally at
54. Referring to FIGS. 4-8, dispenser 54 operates to control the
inflation of the balloon assembly 43 and the discharge of drug
material into the uterine cavity 32. The dispenser 54 has a housing
56 comprising a lower section or part 56A and an upper section or
cover part 56B. A plurality of fasteners 60, as screws, hold the
parts 56A and 56B together. Each part 56A and 56B has a lateral
flange 55 at the rear end of the part to facilitate handling of the
instrument. Housing 56 has three longitudinal cavities 57, 58 and
59 to accommodate the dispensing and control mechanism of the
dispenser. The cavity 57 is in longitudinal alignment with tubular
member 41. The tube 53 extends into the forward end of cavity 57
and terminates in a point 61, thereby forming a tubular needle.
As shown in FIG. 1, the housing 56 has a top opening 62 in
communication with the cavity 57. The opening 62 has a longitudinal
length and width sufficient to permit a container or ampulla 63 to
be inserted into the cavity 67. The container 63 is an elongated
cylindrical member of plastic or glass having a forward end closed
with a rubber or resilient plug 64. Plug 64 is in longitudinal
alignment with the point 61 of tube 53. The opposite end of
container 63 is closed with a piston 66. Drug material 67 is stored
in the container 63. An elongated longitudinal rod or plunger 68 is
slidably located in longitudinal bore 69 in the rear portion of
housing 56. The bore 69 is open to cavity 57 and aligned with the
open end of the container 63. The plunger 68 has an outside head 71
adapted to be engaged by the operator of the instrument. The
opposite end of plunger 68 is a forward end 72 in engagement with
the piston 66.
An elongated cylinder 73 is located in the second cavity 58. The
forward end of cylinder 73 is attached to a tube 74 leading to the
tubular member 41. Tube 74 opens to the passage 42 of the tubular
member 41 whereby the fluid, as air, in the cylinder 73 is
discharged into the passage 42 to expand the sleeve member 44. The
tube 74 and tube 53 are joined to the end of probe 41 with a seal
structure 76, as solder, weld or the like. The open portion of
cylinder 73 has a hole 77 to permit air to flow into the chamber
formed by cylinder 73. The open end of cylinder 73 is closed with a
piston 78. In the initial position, as shown in FIG. 4, the piston
78 is located rearwardly of the hole 77 whereby air can flow into
the chamber of cylinder 73.
Located behind and in longitudinal alignment with the cylinder 73
is an actuator assembly indicated generally at 79 operable to move
the piston 78 into the cylinder 73 and thereby force air through
tube 74 into passage 73 to expand the sleeve member 44. The
actuator assembly 79 functions to apply a predetermined fluid
pressure to the sleeve member to substantially displace the uterine
cavity with the sleeve member and initially monitor the integrity
of the uterus. Preferably, the fluid pressure is from 7 psi to 71/2
psi. The pressure applied to the sleeve member 44 will increase if
the walls of the uterus have sufficient strength to resist
expansion of the sleeve member 44. Weak, diseased or ruptured
uterus walls and enlarged uteri are detected by the instrument as
the sleeve member 44 will not be subjected to the predetermined
fluid pressure since these uterus walls cannot contain the sleeve
member. This checking or monitoring of the integrity of the uterus
walls is done before the drug material is introduced into the
uterine cavity.
Referring to FIGS. 9-11, actuator assembly 79 has a first
cylindrical member 81. The forward or front end of member 81 has a
cone-shaped recess 82 to accommodate the cone-shaped end of piston
78. The member 81 has a longitudinal or axial bore 83 accommodating
a second cylindrical member 84. The member 84 is telescoped into
the bore 83. The outer end of member 84 has a head 86 having an
outer surface adapted to be engaged by the operator of the
instrument. The forward or front end of member 84 has a forwardly
directed projection 87 and an annular shoulder 88. A compression
spring 89 located in bore 83 engages the shoulder 88 and the bottom
of the bore 83, thereby biasing the first member 81 and the second
member 84 away from each other or to an expanded position. The
members 81 and 84 are held in assembled relation with a stop pin
91. Pin 91 is anchored in a hole 92 in member 84 and extends
through a longitudinal slot 93 in member 81. The slot 93 permits
limited relative movement between the members 84 and 81 against the
compression force of the spring 89. The spring 89 has a calibrated
force, preferably 7 to 71/2 psi, whereby the fluid pressure in the
system including the expandable sleeve member 44 is limited to 7 to
71/2 psi. As shown in FIGS. 8 and 11, pin 91 extends downwardly
into a longitudinal groove 90 in the lower section 56A of the
housing. The pin 91 located in groove 90 prevents rotation of the
actuator assembly 79 in the housing 56.
As shown in FIG. 11, the member 84 has a transverse hole 94 in the
forward section thereof accommodating a lock means indicated
generally at 96. Lock means 96 comprises a cylindrical body 97
having an outwardly directed pin or projection 98. The body 97 has
a bore 97A accommodating a compression spring 99. The spring 99
biases the body 97 and projection 98 in an outward transverse or
lateral direction forcing the outer end of projection 98 into
engagement with the inner wall of the member 81. As shown in FIG.
9, the member 81 has a hole 101 in longitudinal alignment with the
lock means 96. When the member 84 is moved into member 81 a
distance to align or register the pin 98 with hole 101, the spring
99 will force the projection 98 through hole 101 into operative
engagement with a control mechanism indicated generally at 102.
Referring to FIGS. 8 and 12, control mechanism 102 comprises an
elongated body 103 slidably disposed in longitudinal cavity 59.
Body 103 has an elongated head 104 positioned in the forward end of
cavity 59. The forward end of head 104 has a downwardly projected
ear 106. Ear 106 has a longitudinal hole 107 accommodating a guide
rod 108. Rod 108 extends linearly the full length of cavity 59 and
has a rear portion located in a hole 109 in body 56A. A removable
transverse pin or stop member 111 extends transversely through the
body intersecting the hole 109, thereby holding the rod 108 in
assembled relation with body 56. A compression spring 112 is
concentrically positioned about the forward end of rod 108. The
forward end of spring 112 engages the ear 106. The rear end of
spring 112 engages a stop collar 113 secured to rod 108. Spring 112
biases the body 103 in a forward direction to a stop position and
yieldably holds the forward end of the head 104 in engagement with
the end wall 114 of cavity 59.
The side of body 103 facing the actuator assembly 79 has a
plurality of linearly spaced fingers or teeth 116. Spaces 117
separate the fingers 116 from each other. The spaces 116 have a
width to accommodate the end of pin 98 to lock the actuator
assembly 79 to the body 103, as shown in FIG. 5, when the actuator
assembly is in its contracted position.
Referring to FIG. 4, the plunger 68 and actuator assembly 79 are
held in an inoperative position by a transverse locking rod or pin
118. The pin 118 extends through a transverse hole 119 in plunger
68 and a transverse hole 121 in plunger assembly 79. The pin
engages the back end wall of housing 56 to prevent both the plunger
68 and actuator assembly 79 from being inadvertently pushed into
the body 56.
In use, the entire instrument is sterilized with the cylinder 63
loaded in cavity 57. The expandable balloon assembly 43 is in a
deflated condition and inserted into the uterine cavity 32 via the
vaginal cavity 27 and cervical passage 31. The ballon assembly 43
is moved up into the uterine cavity 32 until the head 49 is
adjacent the top wall or fundus 36. The pin 118 is removed so that
the actuator assembly 79 can be operated to monitor the integrity
of the walls of the uterus.
The actuator assembly 79 is moved into the body 56. This moves the
piston 78 into the cylinder 73. The fluid, as air, in cylinder 73
flows via tube 74 and passage 43 in tube 41 into the chamber 48
surrounded by sleeve member 44. As shown in FIG. 1, the sleeve
member 44 is expanded until it fills the entire uterine cavity 32.
Portions of the sleeve member 44 expand upwardly to the exit
portions of the Fallopian tube canals 33 and 34. The material of
sleeve member 44, being of soft, relaxed, elastic material,
conforms to the shape of the uterine cavity and readily expands to
fill the uterine cavity. The member 84 of actuator 79 is
continuously moved into body 56 to increase the pressure of the
fluid in the fluid system for the balloon assembly. When the
pressure is at the desired level, i.e., 7 to 71/2 psi, the member
84 will move from its extended position into the member 81 to a
contracted or "in" position. This movement will align pin 98 with
hole 101. Spring 99 will force pin 98 through hole 101 into one of
the spaces 117 of the body 103 of the control mechanism 102. The
pin 98 will engage an adjacent finger 116 to thereby prevent
further movement of the actuator assembly 79 into the cylinder 73.
This limits the pressure of the fluid in sleeve assembly 44 to the
pressure as determined by the compression characteristics of the
spring 89 in the actuator assembly 79.
In the event that there is a leak in the fluid system of the sleeve
member 44 or that the walls of the uterus are weak, diseased or
ruptured they will not have sufficient strength to confine the
sleeve member 44, the actuator assembly 79 will not lock into the
control mechanism 102. The impaired uterus will not develop a
reaction pressure that will establish a pressure of the fluid in
chamber 48 sufficient to overcome the compression characteristics
of spring 89. Accordingly, pin 98 will not move into registration
with hole 101. When the operator releases the pressure on the
actuator assembly 79, the actuator assembly 79 will move back to
its initial position, as shown in FIG. 4, and thereby provide an
indication of deficiency in the strength of the uterine wall. If
there is a leak in the fluid system of sleeve member 44, the
actuator assembly 79 will not return to its initial position as the
pressure in the system is lost. The actuator assembly 79 can be
moved into body 56 until its head 86 abuts against the end of the
body 56. This is the maximum movement of the actuator assembly 79
which limits enlargement or expansion of sleeve member 44.
In the event the uterine walls have sufficient strength, the member
84 will move relative to member 81 of the actuator assembly 79 and
pin 98 will move into registration with the hole 101. Pin 98 is
driven by spring 99 into the body 103, producing an audio click.
This sound signals the operator that the uterus has a size and
strength to accommodate the fully expanded sleeve member 44. If the
uterus walls are weak or if there is a leak in the fluid system,
the pin 98 will not lock into body 103. Accordingly, the audio
click is not produced. Pin 98 locks the actuator assembly 79 to the
body 103, preventing further movement of actuator assembly 79 into
cylinder 73. The operator will then release the pressure on the
actuator assembly 79. The actuator assembly 79, along with piston
78 and body 103, will move in a rearward direction against the
compression force of the spring 112. Spring 112 has a compression
force charactistic of preferably 21/2 to 3 psi. In other words,
when the force on actuator assembly 79 has been released, the
pressure in chamber 48 will drop to 21/2 to 3 psi. As shown in FIG.
2, the sleeve member 44 will contract to fill the lower portion of
the uterine cavity. The pressure in chamber 48 is suffcient to
maintain the sleeve member 44 in continuous and firm engagement
with the side walls 37 and 38 of the uterus.
As shown in FIG. 6, the plunger 68 is moved into body 56. The
plunger 68 forces the plug 64 into engagement with point 61, moving
the point through plug 64. The plunger 68, being in engagement with
piston 66, forces the drug material 67 through the passage of tube
53. As shown in FIG. 2, the material is dispensed in two positions
67A and 67B in opposite directions through the passage 50 of head
49 to oposite sides of the uterine cavity 32 above the partially
expanded sleeve member 44.
Referring to FIG. 7, as soon as the dispensing of the drug material
67 from the container 63 is completed, the operator applies a force
to the actuator assembly 79 to progressively expand the sleeve
member 44. As shown in FIG. 3, sleeve member 44 moves outward to
fill the entire uterine cavity. As the sleeve member 44 expands, it
forces or pushes the drug material up into the canals 33 and 34 of
the Fallopian tubes 23 and 24, respectively. The sleeve member 44
is expanded to its initial expanded position, as shown in FIG. 1.
The actuator 79, being locked to the control mechanism by the pin
98, limits the movement of the actuator into the cylinder 73. The
forward end of head 104 will abut against end 114 to stop the
actuator at its initial position. In this position, the pressure in
the chamber 48 expanding the sleeve member 44, will return to its
initial pressure, i.e. 7 to 71/2 psi. The sleeve member 44 expands
to fully displace the uterine cavity and move the drug materials
67A and 67B into the canals of the Fallopian tubes. In other words,
the expanding sleeve member 44 functions as an expanding diaphragm
pump to force and move the drug materials 67A and 67B into the
respective canals. Sleeve member 44, being in firm engagement with
the inside walls 39, prevents the drug material 67A and 67B from
remaining in uterine cavity 32. As the sleeve member 44 expands, it
does not block or hold the drug material, as it pushes the drug
material into the canals.
When drug materials of the tissue adhesive type are used, canals 33
and 34 will be permanently occluded. Tissue adhesives, as the
cyanoacrylate type, cause fibroplastic proliferation which in time
will hystologically close the canals 33 and 34. The tissue
adhesives polymerize when subjected to moist, living tissue. The
cells adjacent the tissue are damaged and eventually replaced with
fibrous tissue.
The removal of balloon assembly 43 from the uterine cavity is
accomplished by removing the pin 111. This releases rod 108
allowing the body 103 to move outwardly. This permits the actuator
assembly 79 to move outwardly, releasing or relieving the pressure
of the fluid in cylinder 73. This allows the sleeve member 44 to
contract to its initial position whereby the balloon assembly can
be removed from the patient via the cervical opening 31 and vaginal
cavity 29.
The drug material can be one of a number of fluids or semifluids
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, cyanoacrylate type materials or
like materials used as surgical glues. Cyanoacrylate 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-cyanoacryate, 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 be of the type that will temporarily block or occlude
the canals of the Fallopian tubes. After a period of time, the
canals will reopen to resume their normal function. Examples of
other drug materials are contraceptive gels, water, silicone
elastomers and like materials.
While there have been shown and described preferred embodiments of
the dispensing instrument and method of introducing 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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