Note: Descriptions are shown in the official language in which they were submitted.
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~EFORM~BLE RING-SHAPED PESSARY
The invention concerns ~ pessary which i8 particularly applicable~ in
the treatment of prolapse o~ ehe internal female sex organs. See~ from
5 top the pessary is a ring-shaped member of which a~ the least the
outside surface is made of biocompatible material such as a synthetic
material. A pessary of this type is g~nerally known by the name
"Hodge-pessary".
10 Prolapses of the internal fe~ale sex organs resulc from laceration or
streeching of the ~upporting connective tissues lin~ing these organs to
the pelvic wall. The cause may be attributed to many factors, the most
prevalent being hormonal and physical effects of pregnancy and
childbirth.
A prolapse may affect various parts of the internal organs, to wit the
uterus and the anterior and ?osterior vaginal walls, taking into
account that one as well as several of these parts may be affected. A
prolapse of the uterus takes place as a result of weakening of the
20 ligaments which connect it t3 the pelvic wall. A prolapse of the
anterior vaginal wall results from weakening of the supportive tissues
- located between ehe bladder and the vagina: the bladder descends and
forces the anterior vaginal ~all with it.
25 ~ prolapse of the posterior vaginal wall may occur in two different
spots: proximally due to weaXening of the supporting ligaments of the
lowest section of the abdominal cavity floor and distally due to
dilacion of the natural cle-: in the pelvic floor muscles. Both types
of posterior wall collapse can occur entirely independently of each
30 other.
Prolapses may cause unpleasan~ sensations in the abdomen and local
physical discomfort. Conservative treatment of uterine and anterior
vaginal wall prolapses is possible by means of ineroducing a supportive
35 ring or pessary in the vagina.
The known pessary i3 manufac~ured of rigid material such as
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porcelain, ebonite, a hard plastic ~a~erial, etcetera. After insertion
in Che vagina it functions in such manner that the pessary itself lie~
on the pelvic floor muscles and i5 thus supported by them.
Simultaneously it supports the uterus or anterior vaginal wall either
5 direcely through local pressure or indirectly by causing increased
tensening of the supportive tissues involved.
As the pessary itself must lean on the pelvic floor muscles, it should
be large enough to remain positioned on ehe cleft in the pelvic floor
10 even with downwardly directed abdominal pressure. However, in case of
prolapse, the muscles of the pelvic floor are often flaccid and thereby
their cleft is relatively wide, so thae then the pes~ary would descend
with the pelvic floor or sli? outwardly through the widened cleft. A
relatively large pessary, which thereby and by its construction will be
15 of a somewhat resilient naeure, does not solve this problem because it
would laterally serain the vaginal wall too much or, because of its
flexibility, would be pushed oue as easily as it is inserted.
If the pelvic floor muscles have not weakened and thereby the cleft is
20 noe too wide, a pessary of adequate width cannot be inserted,
especially when also the vag nal opening is relatively narrow as this
may happen in post-m~nopause due to involution.
If in case of a major prolapse and wide vaginal cavity a large-sized
25 rigid pessary can be inserted, the uterus and the anterior vaginal wall
may yet prolapse through the orifice of the ring.
The known pessary meets only those requirements which are demanded of
ehe pessary by only a few pa-:icular individual prolapses~ it being
30 no~ed that the individual anaeomical situation depends on five diverse
¦ variables, to wit: the individual build of the vagina and its
surrounding tissue; the nature and the degree of the prolapse; the
condition of the pelvic floor muscles and the width of the vaginal
opening.
The object of the invention is to provide a pessary that entirely meet
with individual requirements in case of pes~ary treatment of a
prolapse.
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This object is attained in that in the pessary according to the
invention the ring is manufactured of such material or such
materials that it can be deformed by hand to any given shape and
the circumferential dimension of the ring can, to some extent,
be increased or decreased by hand, after which the ring retains
the ultimately given shape and circumferential dimension.
Thus, according to the invention there is provided a pessary for
treating prolapses of the female sex organs comprising a ring
member with an outer biocompatible deformable material and a
helically-shaped, non-resilient inner core member, said ring
member being capable of being deformed by hand into various
shapes, the circumferential dimension of said ring member being
capable of being adjusted by hand, and said ring member being
capable of retaining the shape and circumferential dimension
into which it has been deformed or changed by hand to increase
or decrease said circumferential dimension.
The shape and circumferential dimension of a pessary according
to the invention can be perfectly adapted to the individual
anatomy, both prior to and after insertion, so that the ring,
after being inserted, supports both the neck of the bladder and
the uterus but the ring itself is supported as little as
possible by the pelvic floor muscles so that the effect of the
ring depends much less on the quality of theses muscles.
The shape into which the ring should be bent is determined by
the anatomical proportions within the vaginal cavity, an
impression of which may be obtained e.g. by an internal
examination of the vagina. The ring retains the shape and
dimensions which are ultimately given to it, because the ring
has sufficient resistance to deformation due to the pressure
exerted by tissues.
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Essentiall,v all occuring prolapses can be optimally treated with the
pessary according to the invention. Additionally only rings o~ a few
different sizes need be kep~ available in order to meet the demand from
many individual vaginal sizes.
The ring is preferably constructed of a core of stainless steel or
similar material, encased in a flexible casing, preferably consisting
of silicone rubber.
The core has preferably the shape of a spiral of non-resilient
character.
In a ring formed in this wav by a specific choice of the gauge of the
spir-lly ~ound ~nre aDd of ehe spiral dia_ ter in proportion ~o
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the ring diameter, the ring can be of sufficient flexibility to ensble
molding by hand to 8 permanent ~hape and circumferential dimension,
while the ring still offers sufficieot re~istance to deformation caused
by pressure of tissues. Stainless steel ig resistant to influences
5 emanating from the hum~n body and cun be reshaped frequently without
breaking, while silicone rubber is a flexible material with excellent
tissuecompatible qualities.
Advantageously the ring, in its initial form as seen from top, has the
10 contour of an egg-shaped ovalS while from lateral view, as seen towards
the longest dimension, it has the shape of a segment of a circle.
Accordingly constructed the ring, after insertion, can lie with the
upwardly directed pointed end behind the cervix, pushing up the
15 posterior vault, while the upwardly directed rounded end can lie behind
the publis, from that particular spot pushing the vagina up in the
region of the bladder neck, so that the inserted ring leans practically
exclusively on the symphysis pubis and the retropubic place of
attachment of the pelvic floor muscles and the ring itself is then not
20 mainly supported by the pelvic floor muscles. Moreover, because of the
pressure exerted from the abdominal cavity both on the uterus and the
posterior vaginal wall and consequently on the more pointed end of the
ring, the opposite end of the ring is not pushed toward the vaginal
opening, but because of the bow-shape it is pushed further up behind
25 the symphysis so that there is less chance for the ring to be pushed
out, whereas in that both ends of the ring extend upwardly within the
vagina, chances of hindrance during intercourse are minimal.
Advantageously the ring can be fitted with a diaphragm, also enabling
30 the pessary to serve as contraceptive.
The casing can at the least be partially hollow, the cavity (s) being
filled with a liquid or powdered substance consisting preferably of a
medication which can be delivered by diffusion to the pessary-user.
35 Additionally the coating can consist partly of a polymer for
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gradual release of anti-microbi81 agent6, contraceptives or
substituting hormones.
The cavity(s) may also contain therapeutic or measuring apparatus for
S instance electrodes with energy-source for treatment of incontinence by
way of muscle-stimulation, or for measuring the tensions of the vaginal
or uterine muscles. A transmitter may be provided for wirelessly
transmitting ehe measurements.
lO The pessary according to the invention may also serve to relieve
incontinence in that a strip of an elastic material is arranged on the
outside of the ring which strip is fixed along its edges whereas the
space between the strip and the ring is in communication with means for
pumping a fluid into said space so that the strip is expanded. By
15 pumping air into said space e.g. by pushing in a balloon the strip is
expanded so that the urethra is pressed together and closed off.
It is noted that a so-called resilient pessary is known which is formed
by an annular endless coiled spring coated by silicon rubber or a
20 plastic material. Thus by the coiled spring said ring has a resilient
character so that by a deformation a tension is created in the ring
which tends to push the ring back into its initial shape. Therefor a
resilient pessary of this type is easily pressed out and gives only
little support to the bladder neck.
The invention is elucidated further on the basis of the embodiment
shown in the drawing, in which
figure l gives a top view of a pessary according to the invention;
figure 2 shows a pessary in side view;
figure 3 is a cross section on a larger scale along line III-III in
figure l; and
figure 4 shows a pessary for relieving incontinence.
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As shown by the figures, the pessary according to the invention
comprises 8 ring 1 which as geen from top is formed like an egg-shaped
oval, as a result of which the ring has a more pointed end 2 and a
rounder end 3.
s
In side elevation as shown in figure 2 the ring i6 shaped like a
segment of a circle with a radius r and an included angle of preferably
120.
10 As shown in figure 3, the ring consists of a spiral-shaped core 4 of
stainless steel and a casing 5 of silicone rubber enclosing said core.
The silicone rubber may be pigmented so as to offer an esthetic
flesh-colored aspect. The silicone rubber can moreover be impregnated
with silicone oil, resulting in a lubricated outer surface.
In order to meet the large individual differences and proportions of
the vaginal cavity, rings are available of varying nominal diameters R,
for instance a series of rings which, starting with the smallest ring
of R=50 mm runs up to the largest ring of R=90 mm, the width D
20 increasing stepwise from 6 mm to 12 mm.
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As shown by figure 4, a ring-shaped pessary 6 of the type illustrated
in the figures 1-3 is provided with a strip 7 of an elastic material
e.g. silicone rubber which is fixed along its circumferential edges to
25 the outside of the ring so that 8 slit-shaped space is formed between
the inner side of the strip 7 and the ring. Said space is in
communication with a balloon 9 through tube 8 in which a non-return
valve 10 is provided..
30 The pessary 6 is inserted in the vagina so that the strip 7 lies close
to the urethra. By pressure on the balloon 9 a fluid is pumped into the
slit-shaped space whereby the strip 7 is expanded outwardly and the
urethra is pressed together and closed off. By operating the valve 10
the fluid is allowed to escape. Women who suffer from incontinence can
35 regulate their urine release in this mflnner.
