Note: Descriptions are shown in the official language in which they were submitted.
1326187
GYNECOLOGICAL TENACULUM
Background and Field of the Invention
The present invention pertains to gynecological
tenaculums used for gripping the human female uterine cer-
vix to press the cervix about a medical instrument such as
a hysteroscope to prevent the reflux of distension media
from the uterus.
Hysteroscopy involves one type of examination of
the human uterus. The elongated hysteroscope is used with
a surrounding sheath which can have various shapes. The
sheath and hysteroscope are inserted through the uterine
cervix into the uterus. The space between the sheath and
the hysteroscope serves as a conduit for the ingress of a
distension medium. The distension medium such as carbon
dioxide, a saline solution, Dextran (trademark) 70 liquid
solution or Hyskon (trademark) liquid solution, inflates
the uterus to permit viewing of the uterine interior for
disease, trauma or other problems.
When the uterus is filled with the distension
medium, the natural tensile force of the uterine wall can
reflux the medium around the sheath's exterior back
through the cervix. Refluxing is undesirable in most in-
stances because the uterus must remain inflated for proper
examination.
In some instances it is desirable to discharge
controlled amounts of distension medium through the cervix
to contract the uterus for better examination.
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Heretofore, a tenaculum with two pivotally mount-
ed arms having inwardly directed spikes has been used in
hysteroscopic examination. The two spikes are placed a-
gainst the cervix to press it against the sheath. The
gripping action is performed solely by the spikes digging
into the flesh, and the lac~ of impedance of such digging
- causes bleeding, trauma and pain for the patient. It is
sometimes necessary to use two of these tenacula, which
creates awkwardness and hinders mobility.
Other prior devices have used enlarged tubular
members, tubes with enlarged suction sections, and bal-
loons to control refluxing. However these devices do not
`~ provide the advantages of the present invention~
The present invention provides advantages over
the prior art. The inventive gynecological tenaculum com-
prises a pair of movably mounted extension members each of
which branches into two arms. Each arm has a tooth at its
~ end, and an enlarged section adjacent the tooth.
`~i When a medical instrument such as a hysteroscope
and its sheath are inserted through the cervix, the new
tenaculum can be conveniently operated by a single hand to
cause the four teeth and enlarged sections to grip the
`~ cervix and press it against the sheath to stop, or to
~' otherwise control, the reflux of distension media.
The tenaculum places the gripping parts at stra-
tegic points for effective pressure distribution of the
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cervix about the hysteroscope/sheath. The nu~ber of grip-
ping parts reduces the pressure needed at any one point of
contact to properly grip the cervix. Moreover, the grip-
ping and sealing of the cervix is unaffected by the size
and shape of the sheath or enclosure which fits about it.
The enlarged sections minimize the penetration of the
gripping members into the flesh to thus minimize bleeding
and pain. The enlarged sections also provide a surface
for engaging the cervix to thus spread the gripping force
over a larger part of the tenaculum and reduce the force
per s~uare centimeter that is applied to the flesh, to
minimize trauma and bleeding. The inventive effects of
the enlarged sections are also appreciated with extension
members ha~ing a single arm.
The inventive tenaculum can be easily and con-
~- veniently cleaned and is extremely sanitary. Addition-
~, ally, it is not necessary to replace parts, such as seals,
`~ with the present invention. These features and others are
more fully explained in the detailed description that fol-
lows.
i Description of the Drawings
:'
Figure 1 is an isometric view of the new tena-
culum;
Figure 2 is an end elevation of the new tenaculum;
Figure 3 is a front view of the upper part of the
new tenaculum: and
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Figure 4 shows the sheath for a hysteroscope in-
serted through the uterine cervix, with the new tenaculum
gripping the cervix to press it about the sheath.
Description and Operation of a Preferred Embodiment
.
The tenaculum 10 comprises a pair of elongated
lever members 12 and 14. Intermediate of members 12 and
-~ 14 are flat fulcrum bases 16 and 18, respectively, which
`` are pivotally connected by a pivot pin 20.
~ Beyond the flat bases 16 and 18 the extension
`-~ 10 members have handles 22 and 24, respectively. Each handle
22 and 24 has a finger or thumb loop 26 and 28, respec-
tively, and an inwardly projecting ratchet bar 30 and 32,
respectively.
Above flat bases 16 and 18, the members 22 and 24
extend into a pair of trunks 34 and 36 respectively.
Trunk 34 branches into a pair of arms 38 and 40, while
trunk 36 branches into a pair of arms 42 and 44. The arms
38, 40, 42, and 44 each bend inwardly near their ends,
with arms 38 and 40 extending into knobs 46, and arms 42
and 44 extend into knobs 50. The arms 38 and 42 are sub-
stantially straight until they bend into their corre-
sponding knobs, while arms 40 and 44 loop outwardly beyond
~~ arms 38 and 42, and then loop back inwardly, as seen
clearly in Figure 3. Knobs 46 and 50 each have integral
` teeth 54 and 58 of generally conical shape, respectively
projecting therefrom. The shapes of the arms 38, 40, 42,
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and 44 place the teeth 54 opposite teeth 58. The teeth 54
are slightly offset from their corresponding teeth 58
~Figures 1 and 3) so that when the teeth are moved to-
gether when not gripping anything, the points 62 of teeth
54 and points 66 of teeth 58 contact the sides of the op-
positely facing teeth 58 and 54 respectively. This avoids
point to point placement against the flesh in use, and
minimizes trauma.
The knobs 46 and 50 each have a substantially
flat ring 70 and ?4, respectively which surround the base
of teeth 54 and 58 respectively. Each of the aforesaid
members 12 and 14 are one integral piece from its teeth to
its handle.
~- In operation, the tenaculum 10 can be gripped by
a single hand so that one of the fingers and the thumb are
placed through the loops 26 and 28. Directing attention
. . .
to Figure 4, a hysteroscope sheath 77 is shown passing
through the canal of a cervix 79 for purposes of examina-
tion. The tenaculum 10 can be moved to place the arms 38,
40, 42, and 44 about the cervix 79, and the extension mem-
bers 12 and 14 then pivoted so that all the teeth 54 and
58, and all the flat knob surfaces 70 and 74 engage the
cervix 79 to grip it and press it about the sheath 77 with
the desired amount of pressure. In Figure 4, the arms 40
and 44 extend to allow gripping of the posterior of cervix
79 while the arms 38 an~d 42 extend to press against the
:,, ' . ~ : ' . ..
1326187
anterior of cervi~ 79. The outward looping of arms 40 and
44 allows room for the sheath 77 to conveniently fit and
be manipulated therebetween.
- The surfaces 70 and 74 absorb a considerable
part of the compressive force exerted against the cervix
79 and further prevent the penetration of the teeth 54 and
58 into the flesh for any distance greater than the length
of the teeth 54 and 58. The tenaculum's pressure can be
such to block the reflux of distention medium from the
~`10 uterus through the cexYix 79. If desired the pressure of
the tenaculum 10 can be controlled to allow desired
amounts of distention media to be refluxed through the ca-
nal to facilitate examination. The ratchets 30 and 32 can
be interlocked to hold the extension members 12 and 14 in
a locked gripping position~
The single handed operation of the tenaculum 10
` combined with the four points of pressure allow great mo-
bility and control of the gripping of the cervix 79. The
four points of pressure di~tribution provide for less
pressure at each gripping area. During such gripping the
hysteroscope/sheath can be slid back and forth through the
cervix for examination of different parts of the uterus
from a range of distances and perspectives.
The tenaculum 10 can be applied to contact the
cervix either before or after insertion of the sheath, or
of any other medical instrument. The tenaculum 10 can be
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used with hysteroscopes and/or sheaths of all sizes and
shapes.
.There are various changes and modifications which
- may be made to the invention as would be apparent to those
skilled in the art. However, these changes or modifica-
tions are included in the teaching of the disclosure, and
it is intended that the invention be limited only by the
scope of the claims appended hereto.
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