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Claims  |
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What is claimed is:
1. A hypodermic needle assembly adapted for insertion into the uterus
comprising in combination:
an outer elongated housing open at its rearward end and substantially
closed at the opposite forward end except for an axially extending guide
passage therein, and a first finger-engaging means at the open end;
elongated hollow needle guide means extending forwardly from said housing
as a continuation of said guide passage and terminating in a rounded tip
at its forward extremity, closure means associated with the rounded tip to
normally close said guide passage, said guide means adapted to guide
slidable advancement of at least one needle therethrough for forward
extension from the tip at an angle of 10.degree.-15.degree. with respect
to a longitudinal axis through the housing;
at least one needle of limited flexibility disposed in said needle guide
means, said needle having a hollow interior, needle advancing means
disposed in inner concentric relation to said housing and operative to
support said needle for longitudinal slidable advancement through said
needle guide means and said closure means and to extend for a
predetermined distance beyond said tip, said needle advancing means
connected to said needle and extending rearwardly therefrom and
terminating in second finger-engaging means adjacent to said first
finger-engaging means on said housing and said first finger-engaging means
manipulable with one hand to advance said needle forwardly with respect to
said housing and said needle guide means, and
liquid-containing cartridge means disposed in inner concentric relation to
said housing and rearwardly of said needle, said cartridge means being
adapted to be slidable forwardly by manipulation with the same hand into
liquid communication with the interior of said needle and to force fluid
therethrough by manual depression of said cartridge means forwardly
through said housing.
2. A hypodermic needle assembly according to claim 1, including cooperative
guide means between said housing and said needle advancing means to limit
slidable movement of said needle between a retracted position within said
needle guide and an extended position a predetermined distance beyond said
needle guide.
3. A hypodermic needle assembly according to claim 2, said cooperative
guide means operative to lock said needle in the extended position against
accidental rearward movement.
4. A hypodermic needle assembly comprising in combination:
a thin-walled, elongated cylindrical housing having an annular external
flange portion at one open end, the opposite end having an axially
extending narrow guide passage therein;
tubular needle guide means extending forwardly through said guide passage
and terminating in a rounded tip at its distal end, said tip extending
laterally away from the longitudinal axis of said guide passage at an
angle corresponding to the lateral displacement of the cornul portion away
from the longitudinal axis of the uterus;
a needle support member of generally cylindrical, hollow, elongated
configuration disposed in inner concentric relation to said housing, said
support member having a closed end in adjacent but normally spaced aligned
axial relation to said guide passage, and a flange portion at its opposite
end disposed externally of the flange portion on said housing
a needle of elongated tubular configuration fixed at the closed end of
needle support member for forward slidable extension through said tubular
needle guide means and for rearward extension concentrically through the
hollow interior of said needle support, and a pointed end at the forward
extremity of said needle adapted to penetrate body tissue, said needle
being of a length to extend through an opening in said tip and a
predetermined distance beyond the tip of said needle guide means when said
needle support is advanced forwardly into abutting relation with the
opposite end of said housing; and
a disposable cartridge member containing a liquid sclerosing agent inserted
in the open end of said needle support in normally axially spaced relation
to the rearward extremity of said needle, the forward end of said
cartridge being movable into liquid communication with the rearward
extremity of said needle for injection of liquid from the cartridge
through the needle into the body tissue.
5. A hypodermic needle assembly according to claim 4 including a plurality
of needles arranged for coextensive slidable movement through said needle
guide from liquid communication with a common manifold, and a rearward
needle extension from said manifold for liquid communication with said
disposable cartridge.
6. A hypodermic needle assembly according to claim 4, characterized by a
pair of needles arranged for slidable extension through said needle guide,
a needle support for each needle, and a disposable cartridge movable in
each of said needle supports into liquid communication with each of said
needles, and each of said needle supports being independently movable to
advance its associated needle through said needle guide.
7. A hypodermic needle assembly according to claim 4, said needle guide
means having a tip curving laterally away from the longitudinal axis of
said guide passage at an angle of 10.degree.-15.degree..
8. A hypodermic needle assembly according to claim 4, said tip covered with
a rupturable plastic film covering the opening in said tip.
9. A hypodermic needle assembly according to claim 4, said housing and said
needle support having circumferentially offset finger-engaging means at
their rearward ends in normally spaced adjacent relation to one another.
10. A hypodermic needle assembly according to claim 9, said finger-engaging
means on said housing and said needle support defined by radially
outwardly extending, rounded lobe portions.
11. A hypodermic needle assembly adapted for insertion into the uterus
comprising in combination:
an outer elongated housing open at its rearward end and substantially
closed at the opposite forward end except for an axially extending guide
passage therein, and a finger-engaging handle portion at the open end;
elongated needle guide means extending forwardly from said housing as a
continuation of said guide passage and terminating in an enlarged rounded
tip at its forward extremity, said tip provided with guide channels for
forward divergent extension of a plurality of needles therethrough, said
guide means adapted to guide slidable advancement of at least one needle
therethrough for forward extension from the tip at an angle of
10.degree.-15.degree. with respect to a longitudinal axis through the
housing;
a plurality of needles disposed in said needle guide means, needle
advancing means associated with said needle operative to support said
needle for longitudinal slidable advancement through said needle guide
means and for a predetermined distance beyond said tip, said needle
advancing means connected to said needle and extending rearwardly
therefrom and terminating in finger-engaging means adjacent to the
finger-engaging means on said housing and manipulable with one hand to
advance said needle forwardly with respect to said housing and said needle
guide means, and
liqid-containing cartridge means disposed in inner concentric relation to
said housing and rearwardly of said needle, said cartridge means being
slidable forwardly into engagement with each respective needle whereby to
establish liquid communication with the hollow interior of each needle and
to force fluid therethrough by manual depression of said cartridge means
forwardly through said housing.
12. In a hypodermic needle assembly according to claim 1, said closure
means defined by a rupturable plastic film covering said rounded tip of
said elongated hollow needle guide means. |
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Claims |
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Description |
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BACKGROUND OF THE INVENTION
This invention relates to a novel and improved method and instrumentation
for the blind injection of medical solutions into one or more
predetermined locations within a cavity of the body; and more particularly
relates to a novel method and apparatus for occluding the fallopian tubes
for sterilization of females in a rapid, safe and efficient manner.
Various methods and techniques have been devised and utilized over the
years for sterilization or birth control of females. Innumerable types of
contraceptives have been suggested and utilized as a temporary means of
birth control but have never been found to be completely effective.
Similarly, although certain drugs have been found to be an effective means
of temporary sterilization or birth control, side effects of these drugs
is at best uncertain. In any case, none of the temporary means of
sterilization or birth control proposed is capable of providing longterm
sterilization and requires either regular use of dosages in order to be
effective. Of course, surgical procedures are in use which will achieve
permanent sterilization but in most all cases cannot be resorted to as
means of longterm temporary sterilization or birth control.
It is well known that a common cause of sterility is the blockage of the
Fallopian tubes by inflammation, and it follows that an ideal method of
sterilization would be the transvaginal introduction of an inflammatory
agent which would occlude the cornul portion of the tubual lumen, since at
this location in female mammals there is found a narrow canal on opposite
sides of the uterus which is surrounded by dense and highly toxic uterine
muscles resembling a sphincter. The principal difficulties inherent in
this approach to sterilization are not only the utilization of an
inflammatory agent which will reliably produce the necessary occlusion but
in the method and instrumentation of introducing the agent in a blind
fashion so as to assure in each case that the injection is made at
precisely the proper location without pain or injury to the patient.
Moreover, it is highly desirable that the inflammatory agent be injected
on both sides of the uterus.
Studies conducted to date have demonstrated the ability to inject under
direct vision into the uterine cornus of certain female mammals a
sclerosing agent which would produce scarring in animal tissue, i.e., a
chronic lesion over fairly extended time periods. Here, reference is made
to my earlier publications jointly with other authors which describe
earlier work done in the field of female sterilization: "Transvaginal
Delivery of Sterilizing Chemicals" Human Sterilization, (1972); "Chemical
Occlusion at the Uterotubal Junction in Monkeys," American Journal of
Obtetrics Gynec., (1972); "Evaluation of Experimental Methods of Occluding
the Uterotubal Junction," Female Sterilization (1972). In the selection of
a sclerosing agent, particularly good results were realized through the
use of paraformaldelhyde or polyoxymethylene adminstered in an alcohol
solution and injected into the uterine wall in the region of the Fallopian
tubes ostra. Specifically, the results of more recent testing with the use
of paraformaldehyde solutions revealed longterm sterilization for periods
as great as six weeks with little or no apparent side effects, and made
apparent the desirability for a safe, reliable method and instrument for
bilateral injection of the solution at precise locations in the uterus
without benefit of visibility or physical touch and solely by manipulation
and control of the instrument externally of the vagina.
Various types of needle assemblies have been devised in the past for blind
insertion into a cavity of the body including a needle guide so designed
as to guide advancement of the needle along a predetermined angle of
incidence into particular areas or tissue portions in the cavity. In this
relation obstetrical needles have been devised for insertion into the
uterus or other cavities but are not satisfactory for use in the
sterilization procedures accomplished in accordance with the present
invention. Here, for purposes of illustration, reference is made to U.S.
Pat. Nos. 2,700,385 to Ortiz and 2,712,314; 2,740,404, both to Kohl.
Generally, these and other prior art devices are not capable of blind
injection of inflammatory agents into precise locations in the uterus so
as to promote scarring of the tissue and resultant sterilization in a safe
dependable manner. In addition, none comprises a needle assembly with a
disposable cartridge which can be manipulated to follow the sequence of
steps required in carrying out the sterilization procedure of the present
invention.
SUMMARY OF THE INVENTION
It is therefore an object of the present invention to provide for a novel
and improved method and apparatus for sterilization of females which is
safe and dependable in use and is capable of achieving longterm but
temporary sterilization in a simplified, rapid and efficient manner.
It is another object of the present invention to provide for a novel and
improved hypodermic needle assembly which will assure accurate positioning
and guidance of a hypodermic needle into position for the blind injection
of an inflammatory agent at the cornul portion of the tubal lumen; and a
needle assembly which is capable of bilateral, blind injection of an
inflammatory or sclerosing agent into the cornul portion on opposite sides
of the uterus.
It is a further object of the present invention to provide for a hand-held
hypodermic needle assembly which can be easily manipulated with one hand
for insertion of the needle into position internally of the uterus,
penetration of the needle into the tissue, injection of the inflammatory
agent through the needle, and withdrawal of the needle from the tissue,
followed by a repetition of the same sequence of steps on the opposite
side of the uterus without removal of the entire needle guide assembly for
repositioning or relocation of the needle.
It is another object of the present invention to provide for a hypodermic
needle assembly which facilitates positioning and selective extension of
one or more needles and injection of selected quantities of an
inflammatory agent into different selected locations in the uterus in
carrying out female sterilization procedures; and further wherein the
hypodermic needle can be composed at least in part of disposable elements
which are constructed as to prevent contamination of the needle or
accidental introduction of air into the needle guide when the needle is
injected into the tissue.
It is a still further object to provide in a hypodermic needle assembly for
a novel and improved means for selective manipulation of one or more
needles and disposable cartridges in such a way that the assembly can be
grasped with one hand and simultaneously manipulated with the other hand;
and further wherein the needle assembly is lightweight, composed of a
minimum number of parts and facilitates grasping and handling with a
minimum number of operations required for the insertion, penetration of
the needle and injection of the sclerosing agent.
In accordance with the present invention, longterm sterilization is
achieved by the blind injection into the uterus of a schlerosing agent at
the cornul portion of the tubal lumen on opposite sides of the uterus. The
preferred method by which the same is accomplished comprises the steps of
inserting a hypodermic needle assembly into the uterus with a needle guide
disposed for extension at a predetermined angle to the longitudinal axis
of the assembly, the guide being of a predetermined length and attitude so
as to move safely into contact with the cornul portion without danger of
injury to the wall or lining of the uterus. Upon insertion of the needle
guide, one or more needles may be selectively advanced through a
rupturable film which normally closes the end of the guide to penetrate
the tissue at the cornul portion, followed by injecting a sclerosing agent
through the needle to produce a chronic lesion at that point and
consequent blockage of the fallopian tubes. Upon injection of the agent,
the needle is withdrawn from the tissue and the needle guide turned or
rotated into engagement with the cornul portion on the opposite side of
the uterus and the foregong procedure of penetration of the needle and
injection of the agent repeated. The entire procedure can be carried out
by a needle assembly which not only assures accurate placement of the
needle guide and needle without benefit of visibility or touch but also
permits holding and manipulation of the needle and syringe with one hand
so as to leave the other hand completely free to steady and hold the
needle assembly in place.
In the construction of the hypodermic needle assembly, one or more needles
can be selectively advanced through the needle guide either for
simultaneous or successive penetration into the body tissue. In the one
modified form of invention, a double needle assembly has been devised in
which each needle is disposed for independent advancement through a common
needle guide and each needle is operatively associated with a separate
syringe or cartridge for injection of the sclerosing agent through that
needle. The double needle enables use of a separate needle and cartridge
for each cornul portion without removal of the entire assembly from the
uterus. In still another modified form of invention, a tri-needle assembly
has been devised in which three needles are simultaneously advanced to
penetrate an enlarged area of the cornul portion followed by injection of
the agent from a single cartridge simultaneously through the three
needles.
Additional features of the needle assembly in clude mounting and
disposition of single or plural needles in the needle guide as well as the
cooperative disposition of one or more disposable cartridges in a common
housing. A unique form of finger-engaging needle support and guide are
provided to greatly facilitate handling and manipulation of the needles
while assuring that the needles remain in position as the sclerosing agent
is injected therethrough into the tissue. The entire assembly except for
the needle can be constructed of lightweight plastic material requiring a
minimum number of parts which are well balanced and easy to manipulate in
use. In addition, the assembly facilitates the use of a cartridge of the
piston/cylinder type which enables operation and control with one hand.
The above and other objects, advantages and features of the present
invention will become more readily appreciated and understood from a
consideration of the following description when taken together with the
accompanying drawings in which:
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a view of one form of hypodermic needle assembly illustrating
successive placement of the needle guide within the uterus in carrying out
the method of the present invention.
FIG. 2 is a view partially in section illustrating the form of needle guide
assembly shown in FIG. 1 with the needle and cartridge in a retracted
position.
FIG. 3 is a view partially in section of the first form of hypodermic
needle assembly in which the needle is advanced forwardly through the
needle guide for penetration into the body tissue.
FIG. 4 is still another illustration partially in section illustrating
advancement of the syringe or cartridge with respect to the needle in
order to inject an agent through the needle into body tissue.
FIG. 5 is an end view in first form of hypodermic needle assembly shown in
FIGS. 1 to 4.
FIG. 6 is an enlarged view partially in section of the needle guide and
tip.
FIG. 7 is a somewhat perspective showing of the manipulation of the
hypodermic needle assembly in carrying out the method of the present
invention.
FIG. 8 is a cross-sectional view of a modified form of hypodermic needle
assembly employing a tri-needle arrangement within a common needle guide.
FIG. 9 is a cross-sectional view of still another modified form of needle
assembly in accordance with the present invention showing utilization of a
pair of needles and associated syringes within a common housing and needle
guide in accordance with the present invention;
FIG. 10 is an end view of the needle guide assembly illustrated in FIG. 9;
and
FIG. 11 is an enlarged fragmentary view partially in section of the needle
guide and tip in the modified form of FIG. 9.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring in more detail to the drawings, a first embodiment of the present
invention is illustrated in FIGS. 1 to 7 and specifically illustrates a
hypodermic needle assembly 10 comprising an outer housing 12, a needle
guide 14 having a front generally rounded tip 15, a needle 16 adapted for
extension through the needle guide, a needle support 18, and a disposable
syringe or cartridge 20.
As a setting for the present invention, the needle assembly 12 is shown in
FIG. 1 in inserted position within the uterus as generally designated at U
and the cornul portion designated at C of a female mammal, the tip 15
being illustrated in full in contacting relation to the cornul portion C
of the tubal lumen on one side of the uterus. The needle guide is further
illustrated in dotted form when its position is reversed and the tip is
brought into contact with the opposite side of the uterus. In carrying out
the method of the present invention, transcervical tubal occlusion is
achieved by the bilateral injection of a sclerosing agent into the cornul
portions of the tubal lumen on opposite sides of the uterus. In order to
produce a chronic lesion at the cornul portions, a preferred form of
sclerosing agent is a sixteen molar suspension of paraformaldehyde in
alcohol. Paraformaldehyde or polyoxymethylene is a solid, long chain
polymerization of the aldehyde methanal. It has a chemical formula of
(CH.sub.2 O).sub.n and a molecular weight of (30.03).sub.n and is
preferably administered in a suspension of absolute ethanol (C.sub.2
H.sub.5 OH, M.W. 46.07) which can be injected into the uterine wall in the
region of the fallopian tube ostia without producing undesirable side
effects. Molar suspensions of paraformaldehyde in absolute ethanol are
prepared in 10 ml. portions. For a sixteen molar suspension, 4.8078 grams
of paraformaldehyde are added to the ten ml. of ethanol. The molar
concentration possibly could vary between twenty molar and ten molar
depending upon optimal effects of the human uterus. In preparations for
monkeys, sixteen molar was found to be the optimal concentration. Most
desirably a high grade paraformaldehyde is used such as the "Baker Grade"
sold by the J. T. Baker Chemical Company.
The paraformaldehyde solution is placed in a disposable cartridge 20 and as
a preliminary to insertion of the needle guide assembly into the uterus,
the position of the uterus is determined by a bi-manual examination and a
bivalve speculum inserted into the vagina. The cervix is washed with
aqueous zepherin solution and a tanaculum placed in the anterior lip of
the cervix. The cervix may be probed with a uterine sound to determine
patency. Following this, the needle guide is inserted and advanced until
the tip reaches the cornul portion. The needle is then advanced on the
order of five millimeters and 0.5 cc of the sclerosing solution injected
slowly over a fifteen second period of time. The needle is then withdrawn
into the needle guide, the guide rotated or reversed to the opposite side
of the uterus and the same procedure repeated without removing the needle
guide from the uterine cavity.
Considering in more detail the construction and arrangement of the form of
needle assembly shown in FIGS. 1 to 7, the housing 12 is of thin-walled,
elongated hollow cylindrical configuration being open at its rearward end
24 and having a closed forward end 25. The forward end 25 terminates in a
beveled end portion or nose 26, the end being thick-walled and provided
with an inner inclined wall surface 27 and a flat central surface portion
28 disposed normal or perpendicular to the longitudinal axis of the
housing. A guide passage 29 extends axially through the forward end 25 of
the housing for the purpose of anchoring rearward end 32 of the needle
guide 14. The inner wall surface of the housing 12 includes axially
spaced, annular ribs 33 and 34, the uppermost rib 33 being located
adjacent to the rearward open end 24 and the lower rib 34 being located
adjacent to and just rearwardly of the inner inclined surface 27 of the
forward end 25. In addition, finger-engaging lobes or flange portions 36
are arranged at equally spaced circumferential intervals around the
rearward end 24 of the housing, there being a series of three lobes or
flange portions 36 extending radially outwardly from the wall of the
housing as illustrated in FIG. 5 to facilitate grasping of the end of the
outer housing.
The needle guide 14 serves as a means of guiding forward extension of the
needle 16 in a predetermined direction laterally away from the
longitudinal axis of the needle assembly. For this purpose, the needle
guide is comprised of a thin-walled, substantialy rigid tubular portion
having its rearward end 32 permanently affixed within the guide passage 29
of the front end of the housing and having a forward end 38 which
undergoes a gradual bending or curvature away from the longitudinal axis
at an angle approximating 10-15.degree.. The tip 15 of the needle guide is
in the form of a bulbous or rounded, relatively thick-walled sleeve having
a central bore 40 of a diameter corresponding to the inner diameter of the
needle guide 14, and the diameter of the bore 40 is increased as to 40' to
permit snug-fitting insertion of the forward end 38 of the needle guide 14
into the tip 15. The rounded tip 15 is securely bonded to the end of the
needle guide so as to be integrally united thereto with the bore 40
forming a continuation of the forward end 38. In addition, a coating 42
which is in the form of a plastic sheath or covering covers the end of the
tip 15 so as to seal the bore 40 against entry of body secretions when the
needle guide is inserted and also serves to prevent loss of the alcohol
from the sclerosing agent prior to penetration of the needle into the body
tissue; otherwise, when the solution-filled needle is in contact with the
uterine contents, because absolute ethanol alcohol is a dehydrating agent,
as soon as it comes into direct contact with blood and fluid in the
uterine cavity, it is drawn out of the needle leaving only a precipitate
of paraformaldehyde crystal plugging the needle. Coating of the tip with a
plastic film which will occlude the needle aperture at the distal end of
the probe avoids this problems; and when the probe is fixed in the cornu
the needle may be advanced through the film and into the muscle and the
suspension or sclerosing agent injecting without delay.
As shown in FIGS. 2 to 4, the needle 16 is conventionally constructed of a
thin-walled, tubular hypodermic needle composed of stainless steel or
similar material of the desired gauge, the needle being of a length to
extend through the major length of the housing 12 and through the needle
guide 14, and an intermediate portion 44 is fixed within a sleeve 45 which
is mounted within a central bore 46 in the needle support 18. The forward
section 16' of the needle projecting forwardly of the sleeve 45 is of a
length such that when the needle support 18 is in a retracted or raised
position as shown in FIG. 2 the pointed end 48 of the needle is aligned
with the forward extremity of the tip 15; and when the needle support
member is advanced forwardly into abutment with the inner surface of the
front end 25 of the housing, the forward pointed end of the needle will
advance beyond the tip for a distance of five millimeters so as to safely
penetrate the body tissue and muscle at the cornul portion. The needle
also includes a rearward extension 16" which extends rearwardly from the
forward end of the needle support and extends for the greater length of
the housing so as to terminate in a pointed end 49 normally spaced in
front of the end of the disposable cartridge 20.
The needle support 18 serves to control axial advancement of the needle
through the needle guide 14 as well as to lock the needle in its retracted
and extended positions. To this end, the needle support 18 includes a
hollow cylindrical portion 50 extending rearwardly from the front end of
the needle support in spaced inner concentric relation to the housing 12
and terminates at its rearward end in spaced, radially outwardly
projecting, finger-engaging lobes 52. The finger-engaging lobes or flange
portions 52 are so aligned with respect to the lobes 36 on the housing as
to be evenly spaced therebetween; and as shown in FIG. 5 are arranged at
equally spaced circumferential intervals between the lobes 36. The needle
support is centered with respect to the housing by means of the ribs 33
and 34 on the housing wall; and the external surface of the cylindrical
wall 50 is provided with axially spaced annular grooves 53 and 54, the
groove 53 receiving the rib 33 in order to lock the needle in its advanced
position projecting from the tip, and the groove 54 receiving the rib 33
in order to lock the needle in its retracted position. Movement of the
needle between its retracted and advanced positions is of course
controlled by manipulation of the finger-engaging lobes 52 and facilitates
grasping of the underside of the lobes 36 between the thumb and middle
fingers while pressing down on the lobes 52 with the forefinger to urge
the needle forwardly through the needle guide until the rib 33 is locked
in place in the rearwardmost groove 53.
The disposable cartridge 20 may be of conventional construction and as
illustrated in FIGS. 2 to 4 is of the piston/cylinder type having an outer
vial or ampule 60 which contains the liquid medicine and a grooved plunger
62 provided with a hollow bore 63 opening at its rearward end into the
vial and closed as at 64 at its opposite forward end. The forward end 64
includes a centrally located diaphragm 65 which is easily ruptured by the
pointed end 49 of the needle when the cartridge is advanced forwardly
through the needle support 18. The cartridge is guided in its forward
advancement by a hollow cylindrical guide portion 66 directed rearwardly
from the inner surface of the front end of the needle support in inner
spaced concentric relation to the outer wall 50 and to the cylindrical
wall 61 of the cartridge 20 and which threadedly engages the external
surface of the plunger 62. The construction of the cartridge is
conventional and for example may be of the type manufactured and sold by
Bristol Laboratories of Syracuse, New York, under the trademark "Abboject
Syringe," Model No. NDC 0074-4916-01 except that the dimensioning and
configuration are modified and reduced for interworking with the needle
support and housing. In this relation, the disposable cartridge is readily
installed by inserting the plunger within the cylindrical wall 66 and
threading into position. Thereafter, forward advancement of the cartridge
by depressing the vial 60 will cause the pointed end of the needle 49 to
rupture the diaphragm 65 and to move into liquid communication with the
interior of the plunger 62. Continued advancement of the vial will force
the liquid within the vial through the central bore 63 in the plunger and
through the interior of the needle for injection into the tissue. The
external surface of the cartridge 20 is provided with suitable graduations
to measure the amount of agent injected in accordance with conventional
practice. The cartridge 20 may readily be replaced by unthreading the
plunger from the wall support 66 and replacing with a new cartridge,
although it will be apparent that the entire needle assembly may be
comprised of disposable elements and normally would not be designed for
repeated use.
In the modified form of needle assembly illustrated in FIG. 8, like parts
are correspondingly enumerated, the modification residing in a series of
three needles 70, 71 and 72 arranged for slidable extension through the
needle guide 14, the needles 70-72 terminating at their rearward end in a
common manifold 74 which is affixed to the forward end of a single needle
section 75 extending through the needle support 18 and affixed to the
needle support at 44. The manifold 74 establishes liquid communication
between the rearward needle section 75 and the forward needles 70-72, and
at the same time defines a coupling between the needle section with the
rearward needle section having its forward end firmly anchored in one end
of the manifold 74 and the needle sections 70-72 having their rearward
ends firmly anchored in the opposite or forward end of the manifold. The
guide passage 29' in the front end 25' of housing 12' is slightly enlarged
to accommodate a greater size or diameter of needle guide 14', but in
other respects the construction of the housing 12' corresponds to that
described in the first form shown in FIGS. 1 to 7. Similarly, the needle
support 18 corresponds to the needle support shown in the first form.
The needles 70 to 72 each terminate in a front pointed end disposed in
apertures 77 in the rounded tip 76. The rounded tip 76 at the end of the
needle guide 14' differs from the tip 15 of the first form in that
separate guide passages or apertures 77 are formed at equally spaced
circumferential intervals branching or radiating out at a slight angle
from the front extremity of the needle guide so as to function as guide
channels for forward divergent movement of the pointed ends of the needle
through the tip in penetrating into the skin. The angle of divergence
between the apertures or guide channels 77 is very slight, preferably
being on the order of less than 5.degree. with respect to the axis of the
needle guide but sufficient to insure spacing between the pointed ends of
the needles in penetrating the body tissue. In this way, when the
sclerosing agent is injected through the needles it is disseminated over a
wider area to assure a greater region of scarring or lesion at the cornul
portion. However, the total quantity of sclerosing agent injected
corresponds to that previously described.
In the other modified form of invention shown in FIGS. 9 to 11, a double
needle assembly is illustrated. However, its intended use and function
differs from that of the tri-needle concept described with respect to FIG.
8 in that each needle is equipped with a separate cartridge or supply of
sclerosing agent and each is adapted to be independently activated so that
a separate needle can be used for injection into each cornul portion
without necessity of removing the needle assembly from the uterus. In the
modified form of invention as shown, an outer housing takes the form of a
hollow thin-walled casing 80 of generally oval-shaped, cross-sectional
configuration having radially outwardly extending flange portions 81 and
82 at opposite ends of the major axis of rearward open end of the casing.
The casing may be of uniform cross-section throughout its length and at
its forward end has an end cap 83 provided with a forwardly tapered nose
84 and a guide ring 85 mounted at the rearward end of the end cap adjacent
to its point of attachment to the forward end of the housing. The housing
is divided into two separate symmetrical chambers by a central wall or
divider 86 extending the substantial length of the housing and tapering
forwardly so as to terminate at its forward end in inner spaced concentric
relation to the needle guide ring 85. The end cap 83 includes an axially
extending guide passage 87 to receive the rearward end of needle guide 88
which is permanently affixed such as by bonding to the wall of the guide
passage and terminates at its forward extremity in a tip 89 having a pair
of laterally spaced apertures or guide channels 90 in communication with
the interior of the needle guide. A pair of needles 92 are disposed for
slidable extension through the needle guide and terminate in front pointed
ends 93. In turn, rear pointed ends 94 diverge rearwardly through the
casing and each extends into chamber 95 formed at the forward or leading
end of a needle support portion 96. Each needle support 96 is of hollow
generally cylindrical configuration, except for its leading end, and
contains an axially extending needle section 98 in liquid communication
with the chamber 95 and in offset relation to the rearward extremity 94 of
each needle 92, the rearward needle section 98 extending rearwardly along
the horizontal axis of each respective needle support. Each needle support
96 is slidably disposed within a retainer ring 100 on each side of the
divider 86, each ring 100 terminating at its front end in an inwardly
protruding annular rim or lip 101 so as to limit forward movement of the
needle support 96. An external rib 97 on each needle support is slidable
within a longitudinal slot 99 in the guide ring 100 to limit outward
movement of the needle support with respect to the housing. The rearward
open end of each needle support has a radially outwardly projecting,
finger-engaging tab 104 projecting beyond the outer edge of the lobes 81.
Each of the needle supports 96 is designed internally in the same manner as
the first form of needle support described with reference to FIGS. 1 to 7
for the purpose of receiving a conventional form of disposable cartridge
106 through its rearward open end. In the manner previously described with
reference to FIGS. 1 to 7, each disposable cartridge is slidably disposed
in axial alignment with a rearward needle section 98, and upon depression
of the cartridge will cause the needle section to rupture the diaphragm at
the leading end of the cartridge to establish communication with the
interior of the cartridge vial.
In operation, after first inserting the needle assembly in place, one of
the needles is activated by depressing one of the needle supports 96 to
cause forward advancement of the needle tip 93 through the tip of the
needle guide 88. The cartridge 106 associated with that needle support is
then depressed to rupture its diaphragm and by continued inward forcing
cause a selected amount of sclerosing agent to be injected through the
associated needle. The needle is then withdrawn or retracted by lifting up
the finger-engaging tab 104 and repositioning the needle assembly into
alignment with the opposite cornul portion. The other needle is then
advanced and the sclerosing agent injected through the needle into the
other cornul portion and the entire assembly removed. Again a plastic film
or covering 42 is applied over the end of the tip 89 to prevent accidental
loss of the alcohol in the sclerosing agent as earlier described.
From the foregoing, it will be appreciated that a unique method and means
have been devised for female sterilization which permits blind, accurate
injection of a sclerosing agent into the cornul portions of the uterus and
consequent blockage of the fallopian tubes. The length and curvature of
the needle guide in each case is such as to assure accurate placement of
the assembly without injury to the uterine wall and while assuring smooth
advancement of the needle into the tissue as a preliminary to injection of
the agent. The needle assembly as described further facilitates bilateral
injection of the sclerosing agent and minimizes the components and steps
required in carrying out the procedure. It is to be understood that
various modifications and changes may be made in the method and apparatus
of the present invention without departing from the spirit and scope
thereof as defined by the appended claims and reasonable equivalents
thereof.
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