U.S. patent application number 10/715104 was filed with the patent office on 2005-05-19 for vaginal delineation and occlusion device.
Invention is credited to Valtchev, Konstantin L..
Application Number | 20050107818 10/715104 |
Document ID | / |
Family ID | 34574132 |
Filed Date | 2005-05-19 |
United States Patent
Application |
20050107818 |
Kind Code |
A1 |
Valtchev, Konstantin L. |
May 19, 2005 |
Vaginal delineation and occlusion device
Abstract
A vaginal delineator, capable of adjusting to varying lengths of
the cervix and angles of the fornix is disclosed. A diaphragm for
occluding the vagina, preventing leakage of carbon dioxide from the
peritoneal cavity is attachable to the delineator. In an additional
embodiment, the vaginal delineator comprises a cup to which a ring
is pivotally attached. In this embodiment, the cup acts as the
occlusion device.
Inventors: |
Valtchev, Konstantin L.;
(Toronto, CA) |
Correspondence
Address: |
STURM & FIX LLP
206 SIXTH AVENUE
SUITE 1213
DES MOINES
IA
50309-4076
US
|
Family ID: |
34574132 |
Appl. No.: |
10/715104 |
Filed: |
November 17, 2003 |
Current U.S.
Class: |
606/193 |
Current CPC
Class: |
Y10T 29/49826 20150115;
A61B 17/4241 20130101; A61B 2017/4225 20130101; A61B 17/42
20130101 |
Class at
Publication: |
606/193 |
International
Class: |
A61M 029/00 |
Claims
I claim:
1. A method of constructing a vaginal delineator and occluder
comprising a solid ring, a plurality of legs, and a base for
securing said apparatus to a uterine mobilizer; said method
comprising: (a) operably, pivotally mounting the solid ring to the
plurality of legs; and (b) operably affixing the legs to the
base.
2. The method of claim 1 wherein at least some of the plurality of
legs comprise a distal arm, an outer telescoping arm, and an inner
telescoping arm, the method additionally comprising: (a) operably,
securely affixing the distal arm to the base; (b) operably,
pivotally affixing the outer telescoping arm to the solid ring; (c)
engaging a proximal end of the inner telescoping arm into the outer
telescoping arm; and (d) operably, pivotally attaching a distal end
of the inner telescoping arm a proximal end of the distal arm.
3. The method of claim 2, each of the at least some of the
plurality of legs also comprising a spring tending to separate the
base from the solid ring, the method additionally comprising
engaging said spring between the distal arm and the outer
telescoping arm such that the spring bears on the distal arm and
the outer telescoping arm and forces them apart.
4. The method of claim 2 wherein all the plurality of legs comprise
a distal arm, an outer telescoping arm, and an inner telescoping
arm.
5. A method of constructing a vaginal delineator and occluder
comprising a solid ring, a base for securing said apparatus to a
uterine mobilizer, and a cup to obstruct a vagina to prevent
leakage of carbon dioxide from a peritoneal cavity; said method
comprising: (a) operably, pivotally mounting the solid ring to a
rim of the cup; and (b) operably, rigidly mounting the base to the
cup.
6. The method of claim 5 wherein the solid ring is circular and the
pivotal mounting has an axis through a diameter of the ring.
7. The method of claim 5 wherein the solid ring pivots on its
pivotal mounting about 15.degree..
8. The method of claim 7 additionally comprising the steps of: (a)
sloping a rim of the cup is about 15.degree. each way from a
diameter to allow clearance for the ring to pivot; and (b)
operably, pivotally attaching said ring at an apex of the rim.
9. The method of claim 1 wherein the vaginal delineator
additionally comprises a diaphragm of elastic material used to
obstruct a vagina to prevent leakage of carbon dioxide from a
peritoneal cavity, the method additionally comprising the steps of:
(a) constructing the diaphragm with a thicker periphery than a
middle membrane; (b) constructing the diaphragm with a thicker
inner annulus than the middle membrane; and (c) providing a hole in
a center of the diaphragm for receiving the base of the vaginal
delineator and occluder.
10. The method of claim 9 wherein a plurality of sizes of the
diaphragm of elastic material is available.
11. An apparatus for vaginal delineation and occlusion, said
apparatus being inserted into a uterine mobilizer, the apparatus
comprising: (a) a solid ring; (b) a plurality of legs to which the
ring is operably, pivotally mounted; and (c) a base for securing
said apparatus to the uterine mobilizer, the legs being operably
affixed to the base.
12. The apparatus of claim 11 additionally comprising a plurality
of legs, the length of said legs being variable to permit the solid
ring to tilt to accommodate various angles of a fornix.
13. The apparatus of claim 12 wherein the variable-length legs
comprise: (a) a distal arm, securely, operably affixed to the base;
(b) an outer telescoping arm, pivotally affixed to the solid ring;
and (c) an inner telescoping arm connecting the distal arm and the
outer telescoping arm, the inner telescoping arm sliding into the
outer telescoping arm.
14. The apparatus of claim 13 additionally comprising a spring
tending to force the distal arm and the outer telescoping arm
apart.
15. An apparatus for vaginal delineation and occlusion, said
apparatus being constructed to be inserted into a uterine
mobilizer, the apparatus comprising: (a) a cup to obstruct a vagina
to prevent leakage of carbon dioxide from a peritoneal cavity; (b)
a solid ring operably, pivotally mounted to the cup; and (c) a base
for securing said apparatus to the uterine mobilizer, said base
being operably, rigidly mounted to the cup.
16. The apparatus of claim 15 wherein the solid ring is
substantially circular, the apparatus additionally comprising a
pivotal axis through a diameter of the solid ring at which the
solid ring is operably, pivotally mounted to the cup.
17. The apparatus of claim 15 additionally comprising clearance to
permit the solid ring to pivot about 15.degree..
18. The apparatus of claim 17 additionally comprising: (a) a sloped
rim of the cup, said slope being about 15.degree. each way from a
diameter to allow clearance for the ring to pivot; and (b) an
attachment pin, having an axis at an apex of the cup's rim to which
the ring is operably, pivotally attached.
19. An elastic diaphragm for use with a vaginal delineation and
occlusion device, said diaphragm comprising: (a) a hole in a center
of the diaphragm for engaging a base of the vaginal delineation and
occlusion device; (b) a first annulus surrounding said hole; (c) a
membrane of annulus shape bordering an outer circumference of the
first annulus, said membrane being of thinner material than the
first annulus; and (d) an outer periphery being of thicker material
than the membrane.
20. The elastic diaphragm of claim 19 wherein said diaphragm is
made of silicone.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] Not applicable.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] Not applicable.
REFERENCE TO MICROFICHE APPENDIX
[0003] Not applicable.
BACKGROUND OF THE INVENTION
[0004] 1. Field of the Invention
[0005] The present invention relates generally to a medical device.
More particularly the present invention relates to a vaginal
occlusion and self-adjusting delineation attachment for use in a
uterine mobilizer.
[0006] 2. Background Art
[0007] Conventional hysterectomy surgical procedures typically
involve one of four approaches: vaginal hysterectomy, total
abdominal hysterectomy (TAH), total laparoscopic hysterectomy
(TLH), and laparoscopically assisted vaginal hysterectomy (LAVH).
Vaginal, TLH and LAVH have become more popular among surgeons
because these approaches are less invasive than TAH, with TLH being
the least invasive approach. TLH is less invasive than LAVH because
it avoids the trauma normally caused by the expansion induced to
the vaginal area to permit access of the surgeons hands to the
cervical area. Unless medical indications require TAH (such as in
the case of tumor removal and the associated need to avoid cell
spillage), vaginal, TLH and LAVH are usually viewed as more
preferable because each is less invasive when compared to major
abdominal surgery. Thus, TLH and LAVH approaches usually result in
shorter hospitalization and recovery times.
[0008] Difficulties arise in TLH and LAVH, however, in
identification when the vagina is not well delineated. Another
technicality is leakage of carbon dioxide from the peritoneal
cavity when the vagina is opened laparoscopically.
[0009] Another problem, not appropriately addressed in the prior
art, is that human bodies vary considerably. Any vaginal insertion
device for surgical procedures must, therefore, be adjustable. Such
devices are, preferably, self-adjusting.
[0010] There is therefore a need for a vaginal delineation device,
attachable to a uterine mobilizer, that also provides occlusion to
the vagina to disallow leakage of carbon dioxide. There is a
further need for a vaginal delineation and occluding device that is
adjustable, and as self-adjusting as possible.
BRIEF SUMMARY OF THE INVENTION
[0011] An object of the present invention is to provide a vaginal
delineator for use in female pelvic surgical procedures that
attaches to a uterine mobilizer, such as the Valtchev Uterine
Mobilizer, and is self adjusting to various lengths of cervixes and
angles of fornices.
[0012] The present invention is a device that inserts and locks
into a uterine mobilizer, the device comprises a ring that adjusts
in angle. The ring is made to bear against the vaginal fornix,
conforming to its angle and providing delineation of that part of
the vagina for identification thereof.
[0013] In a second embodiment, the ring is also self-adjusting as
to distance from the uterine mobilizer, to accommodate varying
lengths of the cervix. This is effected by pivotally mounting the
ring onto four telescopic rods or legs, all spring loaded.
[0014] A third embodiment of the present invention is configured
like a cup with a rigid ring, pivotally attached at the top of the
cup. Again, the pivotal attachment provides accommodation for
varying angles of the fornix.
[0015] Another object is to provide an occluder to prevent leakage
of carbon dioxide from the peritoneal cavity when the vagina is
opened laparoscopically. An enlarged portion of an extension at the
base of the vaginal delineator, said extension being inserted into
the uterine mobilizer, is made to receive a diaphragm made of an
elastic material such as plastic, silicon, nylon, etc. The
diaphragm obstructs the vaginal cavity toward the outside of the
vaginal delineator, preventing leakage of carbon dioxide from the
peritoneal cavity.
[0016] In the third embodiment of the invention, the cup is the
occluding apparatus as well as the structure on which the
variable-angle, rigid ring is mounted.
[0017] Other objects, advantages and novel features of the present
invention will become apparent from the following detailed
description of the invention when considered in conjunction with
the accompanying drawings.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0018] FIG. 1 is a side elevation view of a uterine mobilizer and a
vaginal delineating and occluding device;
[0019] FIG. 2a is a first side elevation view of the vaginal
delineating and occluding device;
[0020] FIG. 2b is a plan view from the top of the vaginal
delineating and occluding device;
[0021] FIG. 2c is a second side elevation view of the vaginal
delineating and occluding device;
[0022] FIG. 2d is a plan view from the bottom of the vaginal
delineating and occluding device;
[0023] FIG. 2e is a side elevation view of an arm for the vaginal
delineating and occluding device;
[0024] FIG. 3a is a plan view of a diaphragm for the vaginal
delineating and occluding device;
[0025] FIG. 3b is a top view of a diaphragm for the vaginal
delineating and occluding device;
[0026] FIG. 4a is a plan view from the top of a second embodiment
of the vaginal delineating and occluding device;
[0027] FIG. 4b is a side elevation view of the second embodiment of
the vaginal delineating and occluding device;
[0028] FIG. 4c is a plan view from the bottom of the second
embodiment of the vaginal delineating and occluding device;
[0029] FIG. 4d is a first side elevation view of an arm for the
second embodiment vaginal delineating and occluding device;
[0030] FIG. 4e is a second side elevation view of an arm for the
second embodiment vaginal delineating and occluding device;
[0031] FIG. 5a is a side elevation view of a third embodiment of
the vaginal delineating and occluding device minus a solid ring to
clearly show angles;
[0032] FIG. 5b is a cutaway side elevation view of a third
embodiment of the vaginal delineating and occluding device;
[0033] FIG. 5c is a side elevation view of a third embodiment of
the vaginal delineating and occluding device;
[0034] FIG. 5d is a plan view from the top of a third embodiment of
the vaginal delineating and occluding device; and
[0035] FIG. 6 is a cutaway view of a female pelvis, the vaginal
delineating and occluding device being mounted on a uterine
mobilizer and inserted into the vagina.
DETAILED DESCRIPTION OF THE INVENTION
[0036] A first, preferred embodiment of a vaginal delineating and
occluding device 100 is shown in FIG. 1 along with a uterine
mobilizer 110 as disclosed in U.S. Pat. No. 5,562,679 which is
hereby incorporated by reference. The vaginal delineating and
occluding device 100 is attached to the head 120 of the uterine
mobilizer 110. The device shown in detail in FIGS. 2a-e is a first
embodiment of the vaginal delineating and occluding device 100 of
the present invention. A base 205 has an extension 250 for
insertion into the head 120 of the uterine mobilizer 110 and is
locked therein. The proximal end 215 of the base 205 is for
attaching obturators of various lengths. A solid metal ring 200 is
attached to four legs 210, 230. The distal ends of a first pair of
solid legs 210 are firmly affixed to the base 205. The proximal
ends of the legs 210 are pivotally attached to the ring 200 via
pins 220 about which the ring 200 may pivot. The ring 200 is
permitted to pivot about 20.degree. in both directions from a plane
perpendicular to a longitudinal axis of the base 205. This pivoting
permits the accommodation of various angles of the vaginal fornix
620 (see FIG. 6).
[0037] The first pair of legs 210 are preferably of a single piece,
solid throughout.
[0038] The second pair of legs 230 are telescopic and comprise a
plurality of parts as detailed in FIG. 2e. A distal end of a secure
arm 255 is firmly affixed to the base 205. The proximal end of the
secure arm 255 engages a pin 280 to which an inner telescoping arm
265 is pivotally attached. The inner telescoping arm 265 slides
into the distal end of an outer telescoping arm 260. The outer
telescoping arm 260 is pivotally attached to the ring 200 at its
proximal end by a pin 270. The outer telescoping arm 260 is a
hollow tube to receive the proximal end of the inner telescoping
arm 265.
[0039] A diaphragm 225 of elastic material such as plastic, nylon,
silicon, etc. is shown in FIGS. 3a and 3b. Its use is to obstruct
the vagina for the prevention of carbon dioxide leakage from the
peritoneal cavity when the vagina is opened laparoscopically. The
diaphragm 225 has a hole 300 in its center through which an
enlarged portion 275 of the base 205 of the vaginal delineating and
occluding device 100 passes and helps secure the diaphragm 225.
When the distal end of the base 205 is inserted in the uterine
mobilizer 110, the diaphragm 225 is held securely between the base
205 and the mobilizer 110. Various sizes of diaphragms 225 may be
supplied to fit a variety of patients. About the circumference of
the diaphragm 225 is an enlarged portion 310. A center annulus 320
is thicker than a center membrane 330.
[0040] A second embodiment of the vaginal delineating and occluding
device 100 is shown in FIGS. 4a-e. In this embodiment, all the legs
410 are made as the telescoping legs 230, described above. In
addition, a spring 440 applies a force to separate the solid ring
200 away from the base 205. The spring 440 may bear directly on the
secure arm 255 and the outer telescoping arm 260 as shown in FIG.
4d; or it may bear on the inner telescoping arm 265 and the solid
ring 200 as shown in FIG. 4e. In this embodiment, the location of
the solid ring 200 relative to the base 205 is adjustable to
accommodate various lengths of the cervix.
[0041] A third embodiment of the present invention is shown in
FIGS. 5a-d. Here, a cup 500 is illustrated the rim of which has a
slope in two opposite directions, the slope having an angle,
.theta., where .theta. is about 15.degree.. This cup 500 is
attached in the same way into the head 120 of the uterine mobilizer
110 via the extension 250. Pivotally attached at the top if the cup
500 is a rigid ring 510, preferably constructed of a metallic
material. The rigid ring 510 is pivotally attached to pins 520 that
permit the ring to tilt through the angle, .theta., as far as the
rim of the cup 500, again, about 15.degree.. The view in FIG. 5a is
intentionally without the ring 510 to show the angle .theta.. The
ring 510 bears against the fornix 620, while the cup 500 acts to
occlude the vagina, replacing the diaphragm 225 of the previous
embodiments.
[0042] The vaginal delineating and occluding device 100 of the
first embodiment is shown in use in FIG. 6. The vaginal delineating
and occluding device 100 is inserted into a vagina 610 using the
uterine mobilizer 110 until the ring 200 of the vaginal delineating
and occluding device 100 rests against the vaginal fornix 620.
[0043] The above embodiments are the preferred embodiments, but
this invention is not limited thereto. It is, therefore, apparent
that many modifications and variations of the present invention are
possible in light of the above teachings. It is, therefore, to be
understood that within the scope of the appended claims, the
invention may be practiced otherwise than as specifically
described.
* * * * *