U.S. patent application number 13/975634 was filed with the patent office on 2013-12-26 for device and method for illumination of vaginal fornix with ureter location, isolation and protection during hysterectomy procedure.
The applicant listed for this patent is Douglas Ott, Steven Williams. Invention is credited to Douglas Ott, Steven Williams.
Application Number | 20130345521 13/975634 |
Document ID | / |
Family ID | 48427586 |
Filed Date | 2013-12-26 |
United States Patent
Application |
20130345521 |
Kind Code |
A1 |
Williams; Steven ; et
al. |
December 26, 2013 |
DEVICE AND METHOD FOR ILLUMINATION OF VAGINAL FORNIX WITH URETER
LOCATION, ISOLATION AND PROTECTION DURING HYSTERECTOMY
PROCEDURE
Abstract
The present invention comprises devices and methods that, in
certain embodiments, provide a lighted cup, ring or cap that
comprises a customizable size and fit, for use in hysterectomy
procedures, whereby the ring or cup engages the vaginal fornix and
is covered by the vaginal cervical tissue. The lighting allows the
surgeon to visualize the location of the lighted cup, ring or cap,
thereby quickly and accurately identifying the incision site while
providing protection of the associated vasculature and the
ureters.
Inventors: |
Williams; Steven; (White
Bear Lake, MN) ; Ott; Douglas; (Macon, GA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Williams; Steven
Ott; Douglas |
White Bear Lake
Macon |
MN
GA |
US
US |
|
|
Family ID: |
48427586 |
Appl. No.: |
13/975634 |
Filed: |
August 26, 2013 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
13530293 |
Jun 22, 2012 |
|
|
|
13975634 |
|
|
|
|
Current U.S.
Class: |
600/249 |
Current CPC
Class: |
A61B 2090/3945 20160201;
A61B 17/4241 20130101; A61B 2017/00867 20130101; A61B 90/30
20160201; A61B 2090/304 20160201; A61B 2090/0811 20160201; A61B
2017/00115 20130101; A61B 2090/309 20160201; A61M 2025/0166
20130101; A61B 2090/065 20160201; A61B 1/06 20130101; A61B 2090/306
20160201 |
Class at
Publication: |
600/249 |
International
Class: |
A61B 1/06 20060101
A61B001/06 |
Claims
1. A cervical cup, comprising: a body comprising a rim, an outer
lip, a hollow therein and a central aperture therethrough; a
catheter having a lumen therethrough, the catheter disposed within
central aperture; a light source for illuminating a lighting
structure disposed on the outer lip and comprising a lighting
pattern of lights thereon, the light source providing light
selected from the group consisting of visible light wavelengths,
ultraviolet light wavelengths and infrared light wavelengths; and a
pressure sensor switch disposed on the catheter and in operable
communication with a power source and the lights, whereby the
lighting structure is actuated to illuminate at least one of the
light to achieve at least one lighting effect.
2. The cervical cup of claim 1, wherein the lighting structure is
further illuminated by a light tube.
3. The cervical cup of claim 1, wherein the lighting structure is
further illuminated by optical fibers.
4. The cervical cup of claim 1, wherein the lighting structure is
further illuminated by chemical induction.
5. (canceled)
6. The cervical cup of claim 1, wherein the pressure sensor switch
engages the cup and is capable of moving through a distance, each
of the at least one lighting effects correspondent to the distance
moved by the pressure sensor switch.
7. The cervical cup of claim 6, wherein the pressure sensor switch
is mounted in the cup and comprises an aperture therethrough for
sliding passage of the catheter.
8. The cervical cup of claim 7, wherein the sliding passage of the
catheter through aperture of pressure sensor switch comprises a
distance, each of the at least one lighting effects correspondent
to the distance moved by the catheter through the aperture of
pressure sensor.
9. The cervical cup of claim 5, wherein the at least one lighting
effect is within the group consisting of: at least one of the
lights being continually on; at least one of the lights blinking;
shortening the time between the blinking of at least one of the
lights; lengthening the time between the blinking of at least one
of the lights; and changing the wavelength within the visible light
spectrum for at least one of the lights.
10. The cervical cup of claim 9, wherein the lighting structure
further comprises at least one LED light series in the visible
light wavelengths, the series consisting of 1 LED light in the red
spectral region, 1 LED light in the green spectral region, 1 LED
light in the blue spectral region and 1 LED light in the violet
spectral region.
11. A cervical cup, comprising: a body comprising a rim, an outer
lip, a hollow therein and a central aperture therethrough; a
catheter having a lumen therethrough, the catheter disposed within
central aperture; a light source for illuminating a lighting
structure disposed on the outer lip and comprising a regular
lighting pattern of lights comprising at least one LED series, the
series consisting of 1 LED in the red spectral region, 1 LED in the
green spectral region, 1 LED in the blue spectral region and 1 LED
in the violet spectral region; and a pressure sensor switch
disposed on the catheter and in operable communication with a power
source and the LED lights, whereby the lighting structure is
actuated to illuminate at least one of the LED lights to achieve at
least one lighting effect.
12. The cervical cup of claim 11, wherein the lighting structure is
further illuminated by one of the group consisting of a light tube,
optical fibers, and chemical induction.
13. (canceled)
14. The cervical cup of claim 11, wherein the pressure sensor
switch engages the cup and is capable of moving through a distance,
each of the at least one lighting effects correspondent to the
distance moved by the pressure sensor switch.
15. The cervical cup of claim 14, wherein the pressure sensor
switch is mounted in the cup and comprises an aperture therethrough
for sliding passage of the catheter.
16. The cervical cup of claim 15, wherein the sliding passage of
the catheter through aperture of pressure sensor switch comprises a
distance, each of the at least one lighting effects correspondent
to the distance moved by the catheter through the aperture of
pressure sensor.
17. The cervical cup of claim 13, wherein the at least one lighting
effect is within the group consisting of: at least one of the
lights being continually on; at least one of the LED lights
blinking; shortening the time between the blinking of at least one
of the LED lights; lengthening the time between the blinking of at
least one of the LED lights; and changing the wavelength within the
visible light spectrum for at least one of the LED lights.
18. A system for retracting and expanding a lighted cervical cup,
comprising: a conical cervical cup comprising a body formed of a
plurality of radiused, overlapping and slidable leaves defining a
rim and an outer lip, a lighting structure disposed on the body's
outer lip; and a small diameter sheath having a lumen, wherein the
conical cervical cup may be collapsed and retracted into a first
retracted position, the first retracted position comprising a
substantially cylindrical profile and wherefrom the conical
cervical cup may be released into a second expanded position,
wherein the cervical conical cup automatically achieves the second
expanded position upon exposure to a patient's body
temperature.
19. The system of claim 18, further comprising the conical cervical
cup comprising a bias to the second expanded position.
20. The system of claim 19, further comprising at least one spring
connecting the plurality of radiused, overlapping and slidable
leaves, wherein the at least one spring provides a biasing force to
bias the conical cervical cup to the second expanded position.
21. The system of claim 18, further comprising the cervical conical
cup formed of nitinol, wherein the cervical conical cup is biased
to the second expanded position and is deformed when in the first
retracted position.
22. (canceled)
23. (canceled)
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims priority to provisional
application No. 61/560,899, filed on Nov. 17, 2011 and entitled
"Lighting Apparatus and Method for Ureter Location, Isolation and
Protection During Hysterectomy Procedure", the entire contents of
which are incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The invention relates to devices and methods for locating,
isolating and protecting ureters during hysterectomy procedures, in
certain embodiments providing an illuminating cup or ring or cap
over which vaginal cervical tissue is positioned.
[0004] 2. Description of the Related Art
[0005] Known methods of removal of the uterus consist of minimally
invasive methods such as laparoscopy and robotic laparoscopic
methods. See, e.g., U.S. Pat. No. 5,520,698, describing the primary
approaches. A problem that arises during removal of the uterus is
the close anatomical relationship of vascular and ureteral
structures that may be injured. It is known to use a cup or ring
that surrounds the cervix and is used to compress upwardly the
vaginal cervical tissue juncture to compress and deflect these
structures, thereby helping to reduce damage to the ureters and/or
the uterine artery. However, current colpotomizer devices and
methods fail to enable critical visualization of the location of
the colpotomizer device, specifically, the cup ring device. This
failure requires surgeons to awkwardly attempt to locate the device
by instrument palpation, a process that is inaccurate and time
consuming, requiring repetitive reassessment and introduces the
unnecessary hazard of a misguided incision. During robotic
surgeries due to loss of force feedback (haptics), palpation is
either severely reduced or not appreciated and can lead to making
improperly placed incisions, resulting in unnecessary patient
injury.
[0006] In addition, known colpotomy procedures provide a colpotomy
cup which comes in standard sizes, e.g., small, medium and large.
Such cups often do not provide an optimal fit; the cup selected
should just cover the whole cervix. If, for example, the cup is too
large, the ureters will be pulled toward the colpotomy incision,
placing the ureters and potentially the uterine artery at risk of
damage. Standard, non-customized sized cups present an unnecessary
risk to the patient in cases where the fit is not optimal.
[0007] The present invention overcomes these deficiencies.
BRIEF SUMMARY OF THE INVENTION
[0008] The present invention comprises devices and methods that, in
certain embodiments, provide a lighted cup, ring or cap that
comprises a customizable size and fit, for use in hysterectomy
procedures, whereby the ring or cup engages the vaginal fornix and
is covered by the vaginal cervical tissue. The lighting allows the
surgeon to visualize the location of the lighted cup, ring or cap,
thereby quickly and accurately identifying the incision site while
providing protection of the associated vasculature and the
ureters.
[0009] The figures and the detailed description which follow more
particularly exemplify these and other embodiments of the
invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The invention may be more completely understood in
consideration of the following detailed description of various
embodiments of the invention in connection with the accompanying
drawings, which are as follows.
[0011] FIG. 1 is a cutaway of the anatomical region of
interest.
[0012] FIG. 2 illustrates one embodiment of the present
invention.
[0013] FIG. 3 is a perspective view of one embodiment of the
present invention.
[0014] FIG. 4 is a top view of one embodiment of the present
invention.
[0015] FIG. 5 illustrates one embodiment of the present
invention.
[0016] FIG. 5A illustrates one embodiment of the present
invention.
[0017] FIG. 5B illustrates one embodiment of the present
invention.
[0018] FIG. 6 is a top view of one embodiment of the present
invention.
[0019] FIG. 7 illustrates one embodiment of the present
invention.
[0020] FIG. 8 illustrates one embodiment of the present
invention.
DETAILED DESCRIPTION OF THE INVENTION, INCLUDING THE BEST MODE
[0021] While the invention is amenable to various modifications and
alternative forms, specifics thereof are shown by way of example in
the drawings and described in detail herein. It should be
understood, however, that the intention is not to limit the
invention to the particular embodiments described. On the contrary,
the intention is to cover all modifications, equivalents, and
alternatives falling within the spirit and scope of the
invention.
[0022] The present invention comprises devices and methods that
overcome persistent difficulties in hysterectomy procedures. In
various embodiments, a lighted cervical cup comprising lighting
elements disposed around the outer lip of the body of the cervical
cup is provided. As defined herein "cup" also comprises a cap or
ring which are lighted. The lighting elements are sufficiently
bright and of appropriate wavelength to allow penetration of the
vaginal cervical tissue covering the lighted cup. This allows
visualization of the vaginal cervical tissue through an operating
scope or projected by a camera without need for tactile instrument
palpation.
[0023] Thus, using the present device and method, the surgeon is
able to readily and visually, without need for indirect palpation,
locate the position of the lighted cervical cup. Specifically, the
surgeon may readily locate the lighted region of the lighted
cervical cup, over which the vaginal cervical tissue is
positioned.
[0024] Moreover, the known procedures provide a colpotomy cup which
comes in conventional sizes, e.g., small, medium and large. Such
cups often do not provide an optimal fit; the cup selected should
just cover the whole cervix. If, for example, the cup is too large,
the ureters will be pulled toward the colpotomy incision, placing
the ureters and potentially the uterine artery at risk of damage.
Conventional, non-customized sized cups present an unnecessary risk
to the patient in cases where the fit is not optimal.
[0025] Turning now to FIG. 1, illustrates the relevant anatomy
comprising uterus 10, cervix 12, vaginal fornix 14 and the apex 16
of vaginal fornix 14. Ureters 18 are located along essentially the
same plane as apex 16. Extreme care must be taken to not damage the
ureters 18 during the hysterectomy procedure. This is one of the
primary reasons for the present invention: provision of a highly
accurate landmarking tool that does not require palpation in order
to assist the surgeon in accurately locating the fornix and making
accurate incisions while preventing damage to the ureters 18 as
well as the uterine artery.
[0026] FIGS. 2-4 illustrate certain embodiments of the present
invention. Generally, in each embodiment, the lighted cervical cup
100 comprises a body B comprising a rim 110 having an outer lip
112. The cup 100 is formed with a hollow space 120 therein to
receive the cervix 12 and the rim 110 is designed to fit within and
against the vaginal fornix 14. As illustrated, the lighted cervical
cup 100 comprises a spherical shaped profile with approximately one
half of the sphere removed. The skilled artisan will recognize that
any shaping of the lighted cervical cup 100 will work, e.g., an
ellipsoidal shape, as long as the lighted cervical cup 100 receives
the cervix 12 and the rim 110 well fits within and against apex 16
of fornix 14. Each such shape is within the scope of the present
invention.
[0027] FIGS. 2 and 4 illustrate central aperture 140 through
lighted cervical cup 100, not shown in FIG. 3, which, when applied
to the patient's cervical region and positioned with rim 110
against the apex 16 of fornix 14, allows the surgeon to insert
instrumentation therethrough to execute the procedure. Central
aperture 140 may be in fluid communication with insertion catheter
150 comprising a lumen 152 therethrough. Insertion catheter 150 may
be used to facilitate insertion, positioning and movement of the
lighted cervical cup 100 within patient as well as provide a
passage for instrumentation to the surgical area.
[0028] The embodiment of FIG. 3 illustrates an exemplary lighting
structure 130 defining a radial lighting pattern 132 disposed on
the outer lip 112 of the rim 110. As illustrated, a plurality of
lights 134 comprise a regular lighting pattern 132, formed of a
continuous series of individual lights 134, wherein each light 134
is equidistant from the two lights adjacent thereto. The type,
source and wavelength(s) of the lighting structure 130 and lights
134 thereof is discussed further herein.
[0029] The radial lighting pattern 132 may further comprise an
irregular pattern wherein each light 134 in the continuous series
of lights 134 are necessarily equidistant from each other. In
certain embodiments, therefor, an irregular lighting pattern 132 of
the present invention may comprise non-equidistant separations
between adjacent lights 134 or any combination of equidistant and
non-equidistant separations between adjacent lights 134 on the
outer lip 112.
[0030] FIG. 4 illustrates a top view of one possible exemplary
irregular radial lighting patterns 132. FIG. 4 thus illustrates a
lighting pattern 132 comprising a combination of 4 regularly spaced
pairs of lights 134 with regularly spaced triplets of lights 134
therebetween. The skilled artisan will readily recognize additional
irregular lighting patterns 132, each of which is within the scope
of the present invention.
[0031] In an alternate embodiment, the radial lighting structure
130 may comprise one solid light 134 around the outer lip 112.
[0032] Moreover, during the hysterectomy procedure the surgeon
viewing the surgical area laparoscopically and, therefore, is
looking down on the internal side of the vaginal fornix while the
lighted cup of the present invention is on the other side of the
vaginal fornix tissue. Thus, the lighted cup is illuminating the
tissue of the vaginal fornix. Therefore, the surgeon is highly
dependent on the quality of the surgical light and, when used, the
imaging system, to relay information on the health of the tissue as
well as its general appearance. Due to the high attenuation of
visible light in biological tissue, the quality of the light
delivery system to facilitate accurate location of the vaginal
fornix, is of utmost importance.
[0033] One possible lighting source for the present invention is
the xenon arc lamp, which emits over a broad spectrum across the
visible range, providing a color close to daylight. Alternative
sources of light for the present invention comprise laser-phosphor
fibers and supercontinuum lasers. Generally, certain embodiments of
the present invention may comprise a lighting structure 130 that
may utilize all wavelengths of the visible light spectrum while
other embodiments may use certain subsets of the wavelengths
comprising the visible light spectrum.
[0034] For example, another possible light source for the present
invention comprises at least one LED series which may use all
wavelengths of the visible light spectrum in certain embodiments.
In other embodiments, the at least one LED series may comprise 4
LED's: 1 LED in the red, 1 LED in the green, 1 LED in the blue and
1 LED in the violet (.lamda.<430 nm) spectral regions. Each LED
in the LED series comprise relative intensities that may be
adjusted to provide varying levels of white or colored illumination
which may be used to provide greater levels of visual detail to the
surgeon. In this embodiment, as in others discussed herein, more
than one wavelength may be employed to enhance and optimize the
visual clarity and detail during the operative procedure. In other
embodiments, the at least one LED series may comprise LED's from
any wavelength in the visible spectrum and may, therefore, be
customized to the individual preference of the surgeon to maximize
visibility during the surgical procedure, wherein each LED in the
series may comprise or illuminate a different visible light
wavelength, or various combinations thereof to maximize visibility.
Such combination(s) of wave lengths of light energy may be used
individually, or in various combinations, to achieve the desired
detail for providing necessary landmarking functionality as well as
the visual annunciation of the rim of the cup and the vaginal
fornix location.
[0035] Alternatively, the lighting structure 130 may be illuminated
by a using, e.g., the well-known glowstick chemistry to generate
light. In addition, the light selected for the lighting structure
may be externally provided to the cup, e.g., an external light tube
and/or optical fibers, or may be provided by a source internal to
and/or integrated with the lighting structure such as the
previously discussed chemically induced light or by on-board
batteries and the like. In other embodiments, the lighting
structure 130 may be illuminated with infrared and/or ultraviolet
light, with visualization using infrared and/or ultraviolet light
detector devices which are well known to the skilled artisan.
[0036] In further embodiments, the lighting structure 130 may
comprise lights 134 that are continually on once actuated.
Alternatively, the lights 134 may be on intermittently, or blink,
once actuated.
[0037] FIG. 5 illustrates one embodiment of the present invention
wherein the lighted cervical cup 100 is positioned with rim 100 and
outer lip 112 comprising lighting structure 130 engaging the
patient's fornix 14, specifically the apex 16 thereof. Cervix 12 is
received within the hollow 120 of cup 100 and catheter 150
extending through aperture 140 and into uterus 10.
[0038] When the lighted cervical cup 100 is positioned as in FIG.
5, such that the cervix 12 is received within the hollow 120 and
the rim 100 is positioned against the vaginal fornix apex 16, the
surgeon may then optionally, using insertion catheter 150 or,
alternatively, an extension device such as that disclosed, e.g., in
U.S. Pat. No. 5,520,698, incorporated herein by reference, elevate
or extend the vaginal fornix 14 generally toward the patient's
head. This movement elevates the uterine artery in relation to the
ureters 18 and creates a safe separation between the uterine artery
and the ureters 18. The lighting structure 130 allows the surgeon
to view the tissue overlaying the cup's outer lip 112 so that
appropriate landmarks are identified and accurate and precise
incisions may be executed.
[0039] FIGS. 5A and 5B illustrate alternate embodiments of the
lighted cervical cup 100 fitting neatly within apex 16 as shown in
FIG. 5. FIG. 5A provides an actuation device in the form of a
pressure sensor switch 160 in combination and operative
communication with a power source as is well known in the art and
which is in operative communication with the lights 134 in lighting
structure 130 and, therefore, when actuated, pressure sensor switch
160 causes the lights 134 to change status, e.g., illuminate
constantly or blinkingly illuminate, including the ability to
modify the spacing between illuminations by modifying the duty
cycle or pulse width of the lights 134, or illuminate in a varying
wavelength. Each of the variations in illumination of lights 134
are fully controllable by the operator. In the illustrated
embodiment, pressure sensor 160 is attached to catheter 150 at a
measured distance from a distal end D of the catheter and cup 100.
Once the cup 100 is engaged in apex 16 as discussed above, the
operator may apply a sufficient amount of pressure to the catheter
150 so as to engage the pressure sensor switch 160 against the cup
100. The pressure sensor 160 may be actuated through a distance A,
and any variation thereof, in order to actuate the lights 134 and
lighting structure 130. Thus, a slight pressure may move the
pressure sensor 160 a small distance which corresponds to a certain
lighting effect. Moving the pressure sensor 160 slightly further
may correspond to a different lighting effect. Thus, the distance
moved A by pressure sensor switch 160 corresponds with certain
lighting effects which are known to and controllable by the
operator. Such lighting effects may include, but are not limited
to: continuously on for some, or all, lights 134; some, or all,
lights 134 blinking in illumination; some or all lights 134 visible
in certain wavelengths of the visible, ultraviolet and/or infrared
light spectrums; some or all lights 134 visible to an infrared
and/or ultraviolet light detector; modification of the blinking
illumination cycle for some or all lights 134. The skilled artisan
will recognize that a wide variety of lighting effects are
possible, each such possibility is within the scope of the present
invention.
[0040] FIG. 5A illustrates a pressure sensor switch 160 disposed on
the exterior of the cup 100, so that the pressure sensor switch 160
engages the bottom surface of the cup 100 to produce the variable
lighting effects discussed above. FIG. 5B illustrates an
alternative arrangement whereby a pressure sensor switch 160' as
discussed above is located within the cup 100 and disposed thereon
with an aperture therethrough to allow the sliding passage of
catheter 150 once the cup 100 is positioned at apex 16. As the tip
of catheter 150 passes through pressure sensor switch 160', the
lights 134 are actuated to achieve one of the variety of lighting
effects discussed above. The lighting effects may, as above, be
correspondent to a distance A' traveled through sensor switch 160'
aperture 162.
[0041] As further illustrated in FIGS. 5, 5A and 5B the lighted
cervical cup 100 fits neatly and comfortably within the fornix'
apex 16. Thus, there is no stretching or pulling of the surrounding
tissue and, as a result, no distortion of the relative positions of
the relevant anatomy, e.g., the positions of the ureters 18 and/or
uterine artery. However, in known colpotomy cups, an optimal fit
between the cup and the apex 16 is not always achieved, resulting
in movement or distortion of the positions of the relevant anatomy,
presenting a risk of injury to the patient.
[0042] In response, various embodiments of the lighted cervical cup
of the present invention may comprise a first retracted position
wherein the lighted cervical cup comprises a first retracted
position, comprising an essentially cylindrical, and low, profile
and a second expanded position, wherein the lighted cervical cup
expands to custom fit against and within the patient's anatomy,
allowing in certain embodiments to accommodate for and adjust to
local variations in radius of the patient's fornix and apex of the
fornix.
[0043] The retractable lighted cervical cup 200 may comprise in
certain embodiments a body B' formed of a plurality of radiused
overlapping leaves or coils 210 which allow contraction of the
retractable lighted cervical cup 200 to a first retracted position
and expansion to a second expanded position as illustrated in FIGS.
6-8 and with continued reference to FIGS. 1-5. In the illustrated
embodiment, the expanded position comprises a conical profile
wherein the plurality of overlapping leaves or coils 210 are
attached at a hinged base to the end of catheter 150. Each radiused
overlapping leaf or coil 210 may slide over the adjacent leaves or
coils 210 to expand or collapse the device. Thus, retractable
lighted cervical cup 200 is thereby capable of collapsing and
winding a small cylindrical diameter within lumen of small diameter
sheath 220 in the retracted position and unwinding and expanding to
achieve an expanded position. FIG. 6 illustrates a top view of one
embodiment of the retractable lighted cervical cup 200 in a second
expanded position.
[0044] In practice the retractable lighted cervical cup 200 is in
the first retracted position when inserted into the patient's
vaginal cavity and when adjacent the patient's fornix 14 and, in
preparation for receiving the cervix within the hollow 120',
expanded to achieve a second expanded position. Such movement
between the first retracted position to the second expanded
position may be actuated by a wire connecting each of the
overlapping leaves controlled by the surgeon as is known in the
art. Equivalent structures for moving from a retracted to an
expanded position will readily present themselves to the skilled
artisan. Each such structure is within the scope of the present
invention.
[0045] Further, the retracted first position may comprise a
deformed position, wherein the retractable lighted cervical cup 200
is biased to the second expanded position. In such an embodiment,
the cup or ring will, when released from the first retracted
position, automatically move to the expanded second position. For
example, and without limitation, the overlapping leaf embodiment
may comprise one or more springs connecting the overlapping leaves
and which provide a biasing force which tends to move the cup 200
to the expanded second position.
[0046] The biasing force may be overcome by drawing the small
diameter base of the conically profiled cup 200 into the lumen of a
small diameter sheath, thereby causing the leaves to overlap,
winding around each other and to collapse, placing the cup 200 in a
substantially cylindrical profile, i.e., into the first retracted
position. The lighted cup 200 may be biasingly expanded to achieve
the second expanded position by releasing the lighted cup 200 from
the confines of the sheath's lumen, thereby enabling the cup or
ring to automatically biasingly achieve the second expanded
position. The overlapping radiused leaves 210 thus exert a slight
biasing force outwardly, causing the individual leaves 210 against
the patient's anatomy. As a result of this configuration, the
retractable lighted cervical cup 200 may achieve a plurality of
second expanded positions, dependent upon the anatomical
configuration encountered, thereby increasing the accuracy and
safety of the procedure.
[0047] One advantage of the configuration comprising a plurality of
biased second expanded positions which the retractable lighted
cervical cup 200 achieves automatically is that the retractable
lighted cervical cup 200 will only expand to the point at which the
biasing force is again overcome. This allows the cup 200 to expand
to precisely fit within the fornix apex 16, thereby achieving a
custom fit for each vaginal fornix 14 dimension when the apex 16 of
the fornix 14 is engaged by the retractable lighted cervical cup
200. As discussed above, this customized fitting of the cup 200
with the fornix apex 16 allows the relevant anatomy to remain in
position, without movement or distortion caused by an ill-fitting
cup 200.
[0048] Alternatively, the retractable lighted cervical cup 200 may,
in other embodiments, comprise a shape memory alloy wherein the
change from the first retracted position to the second expanded
position occurs upon exposure to a body temperature. A preferred
shape memory alloy comprises Nitinol. Similar to the mechanically
biased embodiment discussed supra, the shape memory embodiments may
also comprise an automatic custom fit ability, whereby the
retractable lighted cervical cup 200 is biased to the second
expanded position upon exposure to body temperature, but when the
cup or ring expands to encounter the anatomical wall, the biasing
force of the shape memory alloy, e.g., Nitinol, is overcome and
expansion stops. Thus, the cup 200 may automatically provide an
expansion custom fit for all vaginal dimensions, allowing for a
custom fit for the cup into the apex 16 of the fornix 14. In this
embodiment, the cup 200 may be formed of overlapping leaves or a
basket or similar structure.
[0049] When the hysterectomy procedure is complete, the surgeon may
either pull the retractable lighted cervical cup 200 distally or
back toward the sheath, engaging the smaller diameter portion 18 of
the retractable cup, thus causing the expanded cervical cup to
collapse and retract within the sheath's lumen 30. When fully
retracted, the flexible shaft 26 and retracted cutting element may
be withdrawn from the patient.
[0050] Thus, a method of using the present invention to position a
lighted cervical cup for a hysterectomy procedure may comprise:
[0051] providing a retractable lighted cervical cup 200 capable of
actuatingly moving from a first retracted position to a second
expanded position;
[0052] advancing the retractable lighted cervical cup 200 into the
patient's vaginal cavity to a position proximate the fornix;
[0053] actuating the retractable lighted cervical cup 200 to an
expanded position;
[0054] positioning the retractable lighted cervical cup 200 within
the patient's fornix, specifically, providing a custom fitting of
the rim and outer lip of the cup 200 within the apex of the
patient's fornix;
[0055] executing and completing the hysterectomy procedure with or
without cervical removal;
[0056] actuating the retractable lighted cervical cup 200 back into
the first retracted position; and
[0057] withdrawing the retractable lighted cervical cup 200 from
the patient.
[0058] The present invention should not be considered limited to
the particular examples described above, but rather should be
understood to cover all aspects of the invention. Various
modifications, equivalent processes, as well as numerous structures
to which the present invention may be applicable will be readily
apparent to those of skill in the art to which the present
invention is directed upon review of the present specification.
* * * * *