U.S. patent number 3,822,702 [Application Number 05/372,971] was granted by the patent office on 1974-07-09 for dispensing method and apparatus.
This patent grant is currently assigned to Population Research Incorporated. Invention is credited to Lee R. Bolduc, Eugene A. Dickhudt.
United States Patent |
3,822,702 |
Bolduc , et al. |
July 9, 1974 |
DISPENSING METHOD AND APPARATUS
Abstract
A fluid dispensing instrument and method for introducing a
fluid, as drug materials, into the canals of the Fallopian tubes of
a primate female. The dispensing instrument has a tubular probe
carrying an expandable balloon assembly. A stop collar on the probe
positions the balloon assembly in the uterine cavity. The balloon
assembly has a sleeve member which is initially expanded to close
the lower portion of the uterine cavity. The drug material is
introduced through the probe into the upper portion of the uterine
cavity above the expanded balloon assembly. The balloon assembly is
then further expanded to force the drug material from the upper
portion of the uterine cavity into the canals of the Fallopian
tubes. The expanding balloon assembly divides the material and
forces the drug material into both of the canals.
Inventors: |
Bolduc; Lee R. (Minneapolis,
MN), Dickhudt; Eugene A. (Minneapolis, MN) |
Assignee: |
Population Research
Incorporated (Minneapolis, MN)
|
Family
ID: |
23470383 |
Appl.
No.: |
05/372,971 |
Filed: |
June 25, 1973 |
Current U.S.
Class: |
128/831;
604/103.03 |
Current CPC
Class: |
A61B
17/42 (20130101); A61M 31/00 (20130101); A61K
9/0039 (20130101); A61F 6/225 (20130101) |
Current International
Class: |
A61B
17/42 (20060101); A61K 9/00 (20060101); A61F
6/00 (20060101); A61F 6/22 (20060101); A61M
31/00 (20060101); A61m 001/00 () |
Field of
Search: |
;128/235,234,232,224,240,241,246,260,216,218,349,127,129,130,1,303,341 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Yasko; J.
Claims
The embodiments of the invention in which an exclusive property or
privilege is claimed are defined as follows:
1. A method of placing material in both canals of Fallopian tubes
open to the uterine cavity of a uterus with an expandable balloon
assembly comprising: introducing the balloon assembly into the
uterine cavity, expanding the balloon assembly into engagement with
the inside side walls of the uterus and spaced from the inside top
wall of the uterus, discharging material into the uterine cavity
between the expanded balloon assembly and the inside top wall of
the uterus, further expanding the balloon assembly into engagement
with the top inside wall of the uterus dividing the material into
two portions and forcing one portion into one canal with one part
of the balloon assembly and the other portion into the other canal
with the other portion of the balloon assembly, contracting the
balloon assembly, and removing the contracted balloon assembly from
the uterine cavity.
2. The method of claim 1 wherein: the balloon assembly is
introduced into the uterine cavity to a selected position with the
balloon assembly spaced from the inside top wall of the uterus.
3. The method of claim 2 wherein: the balloon assembly is held in
the selected position during the discharge of material in the
uterine cavity.
4. The method of claim 1 wherein: the balloon assembly during the
further expansion thereof initially engages the central section of
the inside top wall of the uterus dividing the uterine cavity into
two parts.
5. The method of claim 1 including: discharging a second material
into the uterine cavity before the balloon assembly is
contracted.
6. A method of placing material in both canals of Fallopian tubes
open to the uterine cavity with an expandable sleeve member
comprising: introducing the sleeve member into the uterine cavity,
expanding the sleeve member into engagement with the inside side
walls and top wall of the uterus to displace the uterine cavity,
contracting the expanded sleeve member to move the sleeve member
out of engagement with the inside top wall of the uterus,
discharging material into the uterine cavity between the contracted
sleeve member and the inside top wall of the uterus, expanding the
sleeve member to displace the uterine cavity by moving the sleeve
member into engagement with the inside top wall of the uterus
thereby dividing the material into two portions and forcing one
portion into one canal with one part of the sleeve member and the
other portion into the other canal with another part of the sleeve
member, contracting the sleeve member, and removing the contracted
sleeve member from the uterine cavity.
7. The method of claim 6 wherein: the sleeve member is introduced
into the uterine cavity to a selected position spaced from the
inside top wall of the uterus.
8. The method of claim 6 wherein: the sleeve member during the
second expansion thereof to fully displace the uterine cavity
initially engages the central section of the inside top wall of the
uterus dividing the uterine cavity into two parts.
9. The method of claim 6 including: discharging a second material
into the uterine cavity after the first material has been moved
into the canals and before the sleeve member is contracted for
removal from the uterine cavity.
10. An apparatus for placing material in both canals of Fallopian
tubes comprising: a balloon assembly having an expandable sleeve
member, elongated means supporting the balloon assembly, means on
the elongated means to position the balloon assembly in the uterine
cavity spaced from the inside top wall of the uterus, first means
operable to expand the sleeve member into engagement with the
inside side walls of the uterus, second means for discharging
material into the uterine cavity between the expanded sleeve member
and the inside top wall of the uterus, said first means being
operable to further expand the sleeve member into engagement with
the inside top wall of the uterus whereby the material is divided
into two separate portions, said further expansion of the sleeve
member forcing one portion into one canal of one Fallopian tube and
the other portion into the other canal of the other Fallopian
tube.
11. The apparatus of claim 10 wherein: the sleeve member is made of
expandable tubular sheet material having low surface tension
properties.
12. The apparatus of claim 11 wherein: the means on the elongated
means is an annular collar.
13. The apparatus of claim 10 wherein: the elongated means is a
tubular member connected to the first means and second means.
Description
BACKGROUND OF INVENTION
Bilateral disection of Fallopian tubes is a common surgical
procedure used to sterilize a female primate. 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 the
canals into the uterus. Smith in 1849 described a method to treat
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. Climer in U.S. Pat. No. 3,675,693 and No. 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 canal. 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 the uteri and do not insure that the
materials are placed in each canal of the Fallopian tubes. Also,
these catheters may direct all the material into one canal so that
the material is forced through this canal into the body cavity.
SUMMARY OF INVENTION
The invention is directed to an apparatus and method for dispensing
a fluid, as a drug material, into both canals of the Fallopian
tubes of a primate female. More specifically, the invention is
directed to a method of introducing a predetermined minimum amount
of tissue adhesive into both canals of the Fallopian tubes of a
primate female. The apparatus has an elongated probe having a
forward end attached to an expandable balloon assembly. A stop
collar on the probe functions to position the balloon assembly in
the uterine cavity with the forward end of the balloon assembly
spaced from the top wall or fundus of the uterus. A dispenser
operates to initially expand the balloon assembly to displace the
lower portion of the uterine cavity and form a low pressure seal
with the inner wall of the lower part of the uterus. The balloon
assembly can be fully expanded to sense the size of the uterine
cavity. The balloon assembly is partially contracted to maintain a
low pressure seal with the inner wall of the lower part of the
uterus.
The dispenser is then again actuated to discharge a drug material,
as a tissue adhesive, into the uterine cavity above the balloon
assembly. The balloon assembly is then further expanded to displace
the remaining space of the uterine cavity. The balloon assembly
expands and initially engages the midportion of the fundus and
thereby divides the drug material into separate portions. The
further expansion of the balloon assembly forces the separate
portions of the drug material 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 balloon assembly. 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. A flushing
fluid, as water, can be introduced into the uterine cavity before
the balloon assembly is removed from the cavity. The balloon
assembly is contracted whereby it can be readily removed from the
uterine cavity.
An object of the invention is to provide an apparatus and method of
introducing a predetermined minimum amount of drug materials into
both canals of the Fallopian tubes of a primate female from the
uterine cavity. Another object of the invention is to provide a
method and apparatus 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 further object of the invention is to
provide a method and apparatus for introducing drug materials 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 apparatus for
introducing a fluid material into both canals of the Fallopian
tubes which is not position sensitive and does not apply
substantial pressures to the fluid material whereby the fluid
material is not forced into the blood stream.
IN THE DRAWINGS
FIG. 1 is a sectional view of the reproductive system of a primate
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
balloon in an expanded position to divide the uterine cavity;
FIG. 3 is a sectional view similar to FIG. 2 showing the balloon in
the full expanded position forcing the drug material into both
canals of the Fallopian tubes.
Referring to the drawings, as shown in FIG. 1, a dispensing
instrument indicated generally at 20 in operative relation with the
female reproductive system indicated generally at 21 of a primate
female. System 21 has a uterus 22 and a pair of Fallopian tubes 23
and 24. The lower part of uterus 22 is integral with an elongate
vagina 26. The vagina 26 has a vaginal cavity 27 having an opening
or entrance 28. The opposite end of the cavity 27 is in
communication with the cervix 31 having a cervical opening
providing a passage from the vaginal cavity 27 into the uterine
cavity 32. The Fallopian tubes 23 and 24 each have a canal or
aqueduct 33 and 34 respectively, which open or exit to 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 primate
females vary in size and shape. The 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
configuation. The uterine cavities of the uteri vary in size and
shape. Some uteri have strong walls while others have weak and
realtively elastic walls. Generally, the uterine cavity 32 is
flattened and triangular in shape.
The Fallopian tubes 23 and 24 are paired, trumpet-shaped, muscular
linear members which extend from the superior angles of the uterine
cavity to the ovaries (not shown). The 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 32. Also, the size of the
canals 33 and 34 vary from female to female. The Fallopian tubes
are commonly divided into isthmus, intramural and ampullary
sections. The canals 33 and 34 provide passages for movement of ova
from the ovaries into the uterine cavity 32. The intramural
sections of the Fallopian tubes traverse the uterine wall in more
or less straight fashion. It has an ampullalike dilation just
before it communicates with the uterine cavity 32. 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 layer where
they form with the muscle 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.
The uterus 21 has a top wall or fundus 36 and side walls 37 and 38
surrounding the uterine cavity 32. The inside of the top wall 36
and the side walls 37 and 38 have an inside lining or membrane 39
which periodically is sloughed off in the normal cycle of the
female.
The dispensing instrument 20 has an elongated probe or tubular
support 41 of a length to pass through the vaginal cavity 27 and
into the uterine cavity 32. The longitudinal position of the probe
41 relative to the uterine cavity 32 is determined by an annular
stop member or collar 42. The collar 42 is secured to the probe 41
adjacent the inner end of an expandable balloon assembly indicated
generally at 43.
Balloon assembly 43 has a sleeve member or tubular membrane 44. The
upper or outer end of the member 44 is secured to the support 41
with an annular fastener as a collar or threads 46. A similar
annular fastener 47 secures the inner end of the sleeve member 44
to the probe 41. The probe 41 has a plurality of openings 45 to
provide for communication of fluid from within the probe 41 to the
chamber 69 surrounded by the sleeve member 44.
The 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 elongation of the material. 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. When the cavity 32 is partially
displaced and fully displaced with the expanded sleeve member 44,
as shown in FIGS. 1, 2 and 3, the member 44 is in uniform surface
engagement with the inside wall 39. Conventional balloon
cathethers, being of hard, relatively non-elastic material, do not
assume the configuration of the uterine cavity when expanded under
low pressure.
A dispenser indicated generally at 48 is secured to the outside end
of probe 41. Dispenser 48 has a housing or body 49. A pair of
oppositely directed handles 51 and 52 are secured to the body to
serve as finger grips in the use of the instrument. The housing 49
has chambers for accommodating containers 53 and 54 connected with
passages 56 and 57, respectively. The passages 56 and 57 are open
to the passage in the probe 41. Located between containers 53 and
54 is a third container 58. Container 58 is adapted to be coupled
to elongated tube 59 extended longitudinally through the probe 41.
Tube 59 has an outer or discharge end 61 at the outer end of the
balloon assembly 43. Plungers 62, 63, and 64, slideably mounted on
the housing 49, are operable to apply forces to the containers 53,
54 and 58 and thereby discharge the fluids in the containers via
the probe 41 to the balloon assembly 43 or the uterine cavity 32.
Each plunger has a separate lock 66, 67 and 68 respectively which
holds the plunger in its inactive position. The locks are manually
released, which enables the plungers 62, 63 and 64 to be moved into
the housing 49 and thereby apply forces to the containers
associated with the plungers.
Dispenser 48 can be constructed in accordance with the dispenser as
shown in FIGS. 1 to 10 in pending U.S. Pat. application Ser. No.
361,418. The disclosure of this application is incorporated herein
by reference. Other types of dispensers can be used to provide
fluid under pressure to the balloon assembly 43 and discharge drug
materials, tissue adhesives and the like into the uterine cavity
32.
For example the dispensing apparatus disclosed in pending U.S.
applications Ser. No. 339,911 and Ser. No. 361,418 can be used to
expand te balloon assembly 43 and discharge drug material into the
uterine cavity. The disclosures of these applications are
incorporated herein by reference.
The tissue adhesive can be cyanoacrylate, silver nitrate,
quinacrine material and like material used as surgical glues. The
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-cyanoacrylate, ethyl
cyanoacrylates, n-propyl cyanoacrylates, n-butyl cyanoacrylates,
n-amyl cyanoacrylates, n-hexl cyanoacrylates, n-heptyl
cyanoacrylates, isobutyl-2-cyanoacrylates and n-octyl
cyanoacrylates. Quinacrine material is a relatively thick or heavy
fluid in the nature of a semi-fluid. The pumping action due to the
expansion of the sleeve member 44, hereinafter described, in the
uterine cavity 32 is effective in moving this material from the
uterine cavity into the canals of the Fallopian tubes. The drugs
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.
In use, the dispensing instrument 20 is loaded with the containers
53, 54 and 58. The containers can be preloaded prior to the
operating procedure. With the patient in the reclined position, the
collapsed balloon assembly 43 is moved through the vaginal cavity
27 and through the cervical opening in to the uterine cavity 32.
This located the balloon assembly 43 in the lower part of the
uterine cavity 32. The probe 41 is moved up into the uterus until
the collar 42 is located against the cervix 31, as shown in FIG. 1.
The balloon assembly, being in a deflated condition, slides readily
through the cervical opening and into the uterine cavity 32. The
balloon assembly 43 shown in FIG. 1 is positioned in the central
longitudinal position. This position is not always achieved in the
insertion procedure. The balloon assembly 43 may be located on
either side and extend at an angle toward one of the Fallopian
tubes. The method hereinafter described is operable to move drug
materials into both canals regardless of the position of the
balloon assembly 43 in the uterine cavity. In other words, to be
operable, the balloon assembly is not position sensitive.
The sleeve member 44 then is expanded by introducing fluid, either
liquid or air, under pressure into the balloon cavity 69. The
sleeve member 44 is partially expanded to fill the lower part of
the uterine cavity 32 to form a seal with the inner surface 71 of
the side walls 37 and 38. The top of the balloon assembly 43 is
spaced from the inner wall of the fundus 36. The sleeve member 44
is initially expanded by releasing the lock 66. This permits the
plunger 62 to move into the housing 49, forcing the fluid in the
container 53 into the balloon chamber 69 via the probe 41. Sleeve
member 44 of the balloon assembly being of a low tension expandable
material, places uniform low pressure on the inner surface 71 of
the uterus and assumes the shape of the lower part of the uterine
cavity without subjecting any specific portion of the uterus to
substantial pressure.
Balloon assembly 43 can be fully expanded to sense the size of the
uterine cavity 32. The balloon assembly 43 is partially reduced in
size to move it away from the inner wall 73 of the fundus, thereby
leaving a space between the inner wall 73 and the partially
expanded balloon assembly 43, as shown in FIG. 1.
Drug material 72 is then dispensed from container 58 by releasing
the lock 67. The plunger 63 applies force on the container 58 to
move a controlled amount of material from the container 58 into the
tube 59. The drug material is discharged into the upper end of the
uterine cavity 32, as illustrated by the broken lines and reference
numeral 72. Material 72 is located in the space between the inner
wall 73 and the expanded balloon assembly 43 and is subjected to
only a small amount of pressure.
Referring to FIG. 2, the sleeve member 44 is further expanded until
it engages the inner wall 73 of the fundus 36. The expanding sleeve
member 44 divides the drug material 72 into two substantially equal
portions 72a and 72b. The sleeve member 44 expands into a
cylindrical or egg-shaped configuration and initially engages the
midportion of the inner wall 73.
Referring to FIG. 3, the sleeve member 44 is further expanded by
introducing additional fluid into the balloon chamber 69. The
sleeve member 44 expands to fill or displace the portions of the
uterine cavity leading to the canals 33 and 34 of the Fallopian
tubes. The expansion of the sleeve member 44 forces the drug
materials 72a and 72b under low pressure into the canals 33 and 34.
In other words, the expanding sleeve member 44 functions as a
diaphragm pump to force or move the drug materials 72a and 72b into
the canals 33 and 34 respectively. The sleeve member 44, being in
firm engagement with the inside surface 71 and the inner wall 73,
prevents the drug materials 72a and 72b from remaining in the
uterine cavity 32. As it expands, the sleeve member 44 does not
block or hold drug material as it pushes the drug material into the
canals of the Fallopian tubes.
When drug materials of the tissue adhesive type are used, the
canals 33 and 34 will be permanently occluded. The tissue
adhesives, as the cyonoacrylate type, cause fibroplastic
proliferation which in time will histologically 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 by fibrous tissue.
The sleeve member 44 then is contracted to about the position shown
in FIG. 1. A second fluid, as water, is then injected into the
uterine cavity 32 to dilute and wash away any drug material that
remains in the cavity 32. The sleeve member 44 is then completely
contracted by allowing the fluid in the balloon chamber 69 to drain
back into the dispenser 48 or into a reservoir or container
attached to the dispenser. When the fluid from chamber 69 has been
evacuated, the balloon assembly is withdrawn from the uterine
cavity 32 to conclude the operation.
While there have been shown and described a preferred embodiment of
the dispensing instrument and method of introducing drug material
into both canals of the Fallopian tubes of a primate 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.
* * * * *