U.S. patent application number 14/036129 was filed with the patent office on 2014-03-27 for surgical training model for laparoscopic procedures.
This patent application is currently assigned to Applied Medical Resources Corporation. The applicant listed for this patent is Applied Medical Resources Corporation. Invention is credited to Tracy Breslin, Lee Cohen, Jacqueline DeMarchi, Amy Garces, Charles C. Hart, Adam Hoke, Michael Palermo, Nikolai Poulsen, Serene Wachli.
Application Number | 20140087345 14/036129 |
Document ID | / |
Family ID | 49305200 |
Filed Date | 2014-03-27 |
United States Patent
Application |
20140087345 |
Kind Code |
A1 |
Breslin; Tracy ; et
al. |
March 27, 2014 |
SURGICAL TRAINING MODEL FOR LAPAROSCOPIC PROCEDURES
Abstract
A surgical training model that includes a simulated tissue
having a tubular shape that is connected to a tissue holder is
provided. A portion of the simulated tissue overhangs the distal
end of the tissue holder to simulate a cuff-like entry to the
vaginal vault or resected intestine suitable for practicing
laparoscopic closure of the vaginal vault, intestine or other organ
via suturing or stapling. Two concentric tubular structures are
also arranged over the same tissue holder. A second model includes
two portions of simulated tissue that are held by two holders such
that the simulated tissues are adjacent making the model suitable
for practicing different types of anastomosis procedures. A third
model includes two holders with a single or double tubular
simulated tissue structure connected to and spanning a gap between
the holders. The model isolates the step of closing a cylindrical
opening for the purpose of repeated practice.
Inventors: |
Breslin; Tracy; (Rancho
Santa Margarita, CA) ; Hart; Charles C.; (Rancho
Santa Margarita, CA) ; Wachli; Serene; (Rancho Santa
Margarita, CA) ; Hoke; Adam; (Shelbyville, MI)
; Poulsen; Nikolai; (Rancho Santa Margarita, CA) ;
Palermo; Michael; (Trabuco Canyon, CA) ; Cohen;
Lee; (Rancho Santa Margarita, CA) ; DeMarchi;
Jacqueline; (Rancho Santa Margarita, CA) ; Garces;
Amy; (Rancho Santa Margarita, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Applied Medical Resources Corporation |
Rancho Santa Margarita |
CA |
US |
|
|
Assignee: |
Applied Medical Resources
Corporation
Rancho Santa Margarita
CA
|
Family ID: |
49305200 |
Appl. No.: |
14/036129 |
Filed: |
September 25, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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61705972 |
Sep 26, 2012 |
|
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Current U.S.
Class: |
434/272 |
Current CPC
Class: |
G09B 23/30 20130101;
G09B 23/285 20130101 |
Class at
Publication: |
434/272 |
International
Class: |
G09B 23/28 20060101
G09B023/28 |
Claims
1. A surgical training device, comprising: a model comprising a
first simulated tissue having a tubular form comprising a first
central lumen having an inner surface interconnecting an opening at
the proximal end and an opening at a distal end; the distal end of
the first simulated tissue is compressible; the model includes a
first holder having a proximal end and a distal end; the first
holder is connected to the first simulated tissue such that the
opening at the proximal end of the first simulated tissue is placed
over the first holder locating at least a part of the first holder
inside the first central lumen of the first simulated tissue; the
first simulated tissue being connected to the first holder such
that the opening at the distal end of the first simulated tissue is
distal to the distal end of the first holder by a length defining a
first overhanging portion of the first simulated tissue.
2. The surgical training device of claim 1 wherein the first
simulated tissue and first holder are configured to maintain the
opening at the distal end of the first overhanging portion of first
simulated tissue and the first overhanging portion is compressible
to close the opening at the distal end.
3. The surgical training device of claim 1 wherein the model
includes a second simulated tissue having a tubular form comprising
a second central lumen interconnecting an opening at a proximal end
and an opening at a distal end; the second simulated tissue is
connected to the first holder such that the opening at the proximal
end of the second simulated tissue is placed over the first holder
locating at least a part of the first holder inside the second
central lumen of the second simulated tissue; the second simulated
tissue being connected to the first holder such that the opening of
the distal end of the second simulated tissue is distal to the
distal end of the first holder by a length defining a second
overhanging portion; the first and second simulated tissues being
substantially concentric creating two layers of simulated tissue,
one on top of the other; the first simulated tissue, second
simulated tissue and first holder being configured to maintain the
opening at the distal end of the first overhanging portion and to
maintain the opening at the distal end of the second overhanging
portion; wherein the first and second overhanging portions are
compressible to close the opening at the distal end of the first
simulated tissue and to close the opening at the distal end of the
second simulated tissue.
4. The surgical training device of claim 3 wherein the first
overhanging portion is longer than the second overhanging
portion.
5. The surgical training device of claim 3 wherein the second
simulated tissue is thinner than the first simulated tissue.
6. The surgical training device of claim 3 wherein the second
simulated tissue is red or pink in color and the first simulated
tissue is white in color.
7. The surgical training device of claim 3 wherein the second
simulated tissue is in color contrast with the first simulated
tissue.
8. The surgical training device of claim 3 wherein at least one of
the distal ends of the first and second simulated tissues is
uneven.
9. The surgical training device of claim 1 wherein the model
further includes a base and the first holder is connected to the
base with a first connector that spaces the first holder apart from
the base.
10. The surgical training device of claim 9 wherein the connector
is a flexible arm or gooseneck that permits movement of the holder
with respect to the base.
11. The surgical training device of claim 9 wherein the first
connector rotates with respect to the base.
12. The surgical training device of claim 9 wherein the base
includes a vertical portion and the connector is connected to the
vertical portion.
13. The surgical training device of claim 1 wherein the model
further includes a base connected directly to the first holder.
14. The surgical training device of claim 1 wherein the model
includes a base having a vertical portion to which the holder is
connected.
15. The surgical training device of claim 1 wherein the model
further includes a second holder and a second simulated tissue; the
second simulated tissue having a tubular form comprising a second
central lumen interconnecting an opening at a proximal end and an
opening at a distal end; the second simulated tissue is connected
to the second holder such that the opening at the proximal end of
the second simulated tissue is placed over the second holder
locating at least part of the second holder inside the second
central lumen and the opening at the distal end of the second
simulated tissue is distal to the distal end of the second holder
by a length defining a second overhanging portion of the second
simulated tissue; the first holder and second holder are oriented
with respect to each other such that a gap is defined between the
distal end of the first holder and the distal end of the second
holder.
16. The surgical training device of claim 15 further including a
base configured to removably connect the first holder and the
second holder to the base such that the longitudinal axis of the
first holder is adjacent to and parallel to the longitudinal axis
of the second holder or the longitudinal axis of the first holder
is perpendicular to the longitudinal axis of the second holder with
the distal end of the first holder being adjacent to the distal end
of the second holder.
17. The surgical training device of claim 1 wherein the model is
configured to simulate a vaginal cuff for practicing the closure of
the vaginal vault with suturing or stapling.
18. The surgical training device of claim 1 wherein the simulated
tissue is made of a fabric mesh material over molded with
silicone.
19. The surgical training device of claim 1 wherein the length of
the first overhanging portion is selectable by moving the first
simulated tissue relative to the first holder.
20. The surgical training device of claim 3 wherein the length of
the first and second overhanging portions are each selectable by
moving the first and second simulated tissues relative to the first
holder.
21. The surgical training device of claim 3 wherein the first
simulated tissue is adhered to the second simulated tissue at a
location proximal to their distal ends with the inner surface of
the second simulated tissue being separable from the first
simulated tissue at the distal end.
22. The surgical training device of claim 15 wherein the length of
the second overhanging portion is selectable by moving the second
tissue portion relative to the second holder.
23. The surgical training device of claim 1 further including a
surgical trainer comprising: a base; a top cover connected to and
spaced apart from the to define an internal cavity between the top
cover and the base; at least one aperture or a penetrable region
for accessing the internal cavity; a laparoscopic camera disposed
inside the cavity and configured to display video images on a video
monitor located outside of the cavity and connected to the camera;
wherein the model is disposed inside the cavity and accessed with
instruments via the at least one aperture or penetrable region for
practicing laparoscopic surgical techniques on the model.
24. The surgical training device of claim 1 wherein the first
simulated tissue has an elliptical or circular cross-section.
25. The surgical training device of claim 1 wherein the first
holder has an elliptical or circular cross-section.
26. A surgical training device comprising: a first simulated tissue
having a tubular form comprising a first central lumen
interconnecting an opening at a proximal end and an opening at a
distal end; a first holder having a proximal end and a distal end;
the first holder is connected to the first simulated tissue such
that the opening at the proximal end of the first simulated tissue
is placed over the first holder locating the first holder at least
partially inside the first central lumen of the first simulated
tissue; and a second holder having a proximal end and a distal end;
the second holder is connected to the first simulated tissue such
that the opening at the distal end of the first simulated tissue is
placed over the second holder locating the second holder at least
partially inside the first central lumen at the distal end of the
first simulated tissue; wherein the distal end of the first holder
is spaced apart from the distal end of the second holder by a
length defining a gap that is spanned by the first simulated
tissue.
27. The surgical training device of claim 26 wherein the first
simulated tissue is compressible and severable.
28. The surgical training device of claim 26 wherein the first
simulated tissue includes a simulated tumor in the location of the
gap.
29. The surgical training device of claim 26 wherein further
including a second simulated tissue structure concentric with the
first simulated tissue structure.
30. The surgical training device of claim 26 wherein the first
holder and the second holder are connected to the same base.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to and benefit of U.S.
Provisional Patent Application Ser. No. 61/705,972 entitled
"Surgical training model for laparoscopic procedures" filed on Sep.
26, 2012 which is incorporated herein by reference in its
entirety.
FIELD OF THE INVENTION
[0002] This application is generally related to surgical training
tools, and in particular, to simulated tissue structures and models
for teaching and practicing various surgical techniques and
procedures related but not limited to laparoscopic, endoscopic and
minimally invasive surgery.
BACKGROUND OF THE INVENTION
[0003] Medical students as well as experienced doctors learning new
surgical techniques must undergo extensive training before they are
qualified to perform surgery on human patients. The training must
teach proper techniques employing various medical devices for
cutting, penetrating, clamping, grasping, stapling, cauterizing and
suturing a variety of tissue types. The range of possibilities that
a trainee may encounter is great. For example, different organs and
patient anatomies and diseases are presented. The thickness and
consistency of the various tissue layers will also vary from one
part of the body to the next and from one patient to another.
Different procedures demand different skills. Furthermore, the
trainee must practice techniques in varying anatomical environs
that depend on factors such as the size and condition of the
patient, the adjacent anatomical landscape and the types of
targeted tissues and whether they are readily accessible or
relatively inaccessible.
[0004] Numerous teaching aids, trainers, simulators and model
organs are available for one or more aspects of surgical training.
However, there is a need for model organs or simulated tissue
elements that are likely to be encountered in and that [0005]
H:\CLIENT\PROSECUTION FILES\5441\Specification.sub.--1.doc can be
used in practicing endoscopic, laparoscopic, minimally invasive
surgical procedures. In laparoscopic or minimally invasive surgery,
a small incision, as small as 5-10 mm is made through which a
trocar or cannula is inserted to create a channel for the insertion
of a camera, such as a laparoscope. The camera provides a live
video feed capturing images that are then displayed to the surgeon
on one or more monitors. At least one additional small incision is
made through which another trocar/cannula is inserted to create a
pathway through which surgical instruments can be passed for
performing procedures observed on the monitor. The targeted tissue
location such as the abdomen is typically enlarged by delivering
carbon dioxide gas to insufflate the body cavity and create a
working space large enough to safely accommodate the scope and
instruments used by the surgeon. The insufflation pressure in the
tissue cavity is maintained by using specialized trocars.
Laparoscopic surgery offers a number of advantages when compared
with an open procedure. These advantages include reduced pain,
reduced blood and shorter recovery times due to the smaller
incisions.
[0006] Laparoscopic or endoscopic minimally invasive surgery
requires an increased level of skill compared to open surgery
because the target tissue is not directly observed by the
clinician. The target tissue is observed on monitors displaying a
portion of the surgical site that is accessed through a small
opening. Therefore, clinicians need to practice visually
determining tissue planes, three-dimensional depth perception on a
two-dimensional viewing screen, hand-to-hand transfer of
instruments, suturing, precision cutting and tissue and instrument
manipulation. Typically, models simulating a particular anatomy or
procedure are placed in a simulated pelvic trainer where the
anatomical model is obscured from direct visualization by the
practitioner. Ports in the trainer are employed passing instruments
to practice techniques on the anatomical model hidden from direct
visualization. Simulated pelvic trainers provide a functional,
inexpensive and practical means in place of expensive cadaver labs
to train surgeons and residents the basic skills and typical
techniques used in laparoscopic surgery such as grasping,
manipulating, cutting, knot tying, suturing, stapling, cauterizing
as well as how to perform specific surgical procedures that utilize
these basic skills. Simulated pelvic trainers are also effective
sales tools for demonstrating medical devices required to perform
these laparoscopic procedures.
[0007] One of the techniques mentioned above that requires practice
in laparoscopic minimally invasive surgery is suturing or stapling.
For example, in laparoscopic hysterectomies in which the uterus is
laparoscopically removed, the vaginal vault is closed by suturing.
It is desirable to present a model for practicing this suturing or
stapling of the vaginal cuff and other OB/GYN surgical skills.
Hence, it is desirable to have a model that not only simulates the
particular anatomy but also presents the anatomy at a particular
step or stage of the procedure or isolates a particular step of a
procedure for the trainee to practice in a simulated laparoscopic
environment. The model is then disposed inside a simulated
laparoscopic environment such as a laparoscopic trainer in which it
is at least partially obscured from direct visualization. A camera
and monitor provide visualization to the practitioner. After a
technique is practiced, it is furthermore desirable that such a
model permits repeatable practice with ease, speed and cost
savings. In view of the above, it is an object of this invention to
provide a surgical training device that realistically simulates an
anatomy, isolates such anatomy and presents such an anatomy at a
particular stage or step of a procedure that also enables
repeatable practice. It has been demonstrated that the use of
simulation trainers greatly enhances the skill levels of new
laparoscopists and are a great tool to train future surgeons in a
non-surgical setting. There is a need for such improved, realistic
and effective surgical training models.
SUMMARY OF THE INVENTION
[0008] According to one aspect of the invention, a surgical
training device for training laparoscopic surgical skills is
provided. The training device includes a simulated tissue model
having a first simulated tissue. The first simulated tissue has a
tubular form comprising a first central lumen having an inner
surface interconnecting an opening at the proximal end and an
opening at a distal end. At least the distal end of the first
simulated tissue is compressible. The model further includes a
first holder having a proximal end and a distal end. The first
holder is connected to the first simulated tissue such that the
opening at the proximal end of the first simulated tissue is
stretched over the first holder locating at least a part of the
first holder inside the first central lumen of the first simulated
tissue. The first simulated tissue is connected to the first holder
such that the opening at the distal end of the first simulated
tissue is distal to the distal end of the first holder by a length
defining a first overhanging portion of the first simulated tissue.
The overhanging portion simulates a vaginal cuff which is sutured
or stapled closed by the practitioner.
[0009] According to another aspect of the invention, surgical
training device is provided. The surgical training device includes
a first simulated tissue having a tubular form comprising a first
central lumen interconnecting an opening at a proximal end and an
opening at a distal end. The training device further includes a
first holder having a proximal end and a distal end. The first
holder is connected to the first simulated tissue such that the
opening at the proximal end of the first simulated tissue is
stretched over the first holder locating the first holder at least
partially inside the first central lumen of the first simulated
tissue. The training device includes a second holder having a
proximal end and a distal end. The second holder is connected to
the first simulated tissue such that the opening at the distal end
of the first simulated tissue is stretched over the second holder
locating the second holder at least partially inside the first
central lumen at the distal end of the first simulated tissue. The
distal end of the first holder is spaced apart from the distal end
of the second holder by a length defining a gap that is spanned by
the first simulated tissue.
[0010] According to another aspect of the invention, a surgical
training device is provided. The surgical training device includes
an elongate first simulated tissue made of flexible material and
having an outer surface and an inner surface. The inner surface
defines a lumen interconnecting an opening at a distal end and an
opening at a proximal end. The first simulated tissue is
compressible such that the distal end of the lumen is closable. The
training device further includes a base having an upper surface and
a lower surface and a first holder having a proximal end and a
distal end. The proximal end of the first holder is connected to
the upper surface of the base and extends upwardly from the base.
The first simulated tissue is connected to the first holder such
that the proximal end of the first simulated tissue is connected to
the first holder and the distal end of the first simulated tissue
is distal to the distal end of the first holder by length defining
a first overhanging portion of the first simulated tissue. The
first overhanging portion maintains the opening at the distal end
when connected to the first holder and the first overhanging
portion is compressible to close the distal opening.
[0011] According to another aspect of the invention, a surgical
training device is provided. The surgical training device includes
an elongated simulated tissue structure made of a flexible material
configured to hold surgical sutures and having a thickness between
an outer surface and an inner surface. The inner surface of the
simulated tissue structure defines a central lumen interconnecting
an opening at a distal end and an opening at a proximal end. The
simulated tissue structure has a circular or elliptical
cross-section and an elastic tubular form that maintains the lumen
opening when unstressed and is compressible under pressure to close
the lumen. The simulated tissue structure is configured to be
connected to a holder by being placed over the holder. The
simulated tissue structure is configured to be connected to a
holder by stretching the proximal end of the simulated tissue
structure onto the distal end of the holder. The surgical training
device further includes a holder having a distal end and a proximal
end. The holder is sized and configured to fit inside the lumen of
the simulated tissue structure such that the proximal end of the
simulated tissue structure is stretched to insert the holder into
the lumen and allowed to elastically contract onto the holder to
maintain the simulated tissue structure connected to the holder.
The simulated tissue structure is connected to the holder such that
the opening at the distal end of the simulated tissue structure is
distal to the distal end of the holder by a length defining an
overhanging portion. The opening at the distal end of the
overhanging portion is closable by compressing opposite sides of
the simulated tissue structure. The opening at the distal end of
the overhanging portion is closable by passing sutures through the
overhanging portion to bring opposite sides of the simulated tissue
structure together. The surgical training device includes a second
elongated simulated tissue structure sized and configured to
concentrically fit inside the simulated tissue structured. The
second simulated tissue structure is made of flexible material and
configured to hold surgical sutures and having a thickness between
an outer surface and an inner surface. The inner surface of the
second simulated tissue structure defines a central lumen
interconnecting an opening at a distal end and an opening at a
proximal end. The surgical training device further including clips
configured to hold the simulated tissue structure connected to a
base.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 illustrates a top perspective view of a surgical
training device according to the present invention.
[0013] FIG. 2 illustrates a side perspective, partially transparent
view of a cuff model with two cuffs according to the present
invention.
[0014] FIG. 3 illustrates a side perspective view of a cuff model
showing a base, connector and cuff holder without a cuff according
to the present invention.
[0015] FIG. 4 illustrates a side view of a cuff model according to
the present invention.
[0016] FIG. 5 illustrates a side view of a cuff model according to
the present invention.
[0017] FIG. 6 illustrates a side view of a cuff model according to
the present invention.
[0018] FIG. 7 illustrates a side perspective view of a single cuff
according to the present invention.
[0019] FIG. 8 illustrates a top perspective view of a cuff model
without one or more cuffs according to the present invention.
[0020] FIG. 9 illustrates a top perspective, partially transparent
view of a cuff model with two cuffs according to the present
invention.
[0021] FIG. 10 illustrates a side, partially transparent view of a
cuff model with four cuffs according to the present invention.
[0022] FIG. 11 illustrates a side, partially transparent view of a
cuff model with one cuff according to the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0023] A surgical training device 10 that is configured to mimic
the torso of a patient such as the abdominal region is shown in
FIG. 1. The surgical training device 10 provides a body cavity 12
substantially obscured from the user and configured for receiving
simulated or live tissue or a training model of the like described
in this invention. The body cavity 12 is accessed via a tissue
simulation region 14 that is penetrated by the user employing
devices to practice surgical techniques on the tissue or organ
model found located in the body cavity 12. Although the body cavity
12 is shown to be accessible through a tissue simulation region, a
hand-assisted access device or single-site port device may be
alternatively employed to access the body cavity 12. An exemplary
surgical training device is described in U.S. patent application
Ser. No. 13/248,449 entitled "Portable Laparoscopic Trainer" filed
on Sep. 29, 2011 and incorporated herein by reference in its
entirety. The surgical training device 10 is particularly well
suited for practicing laparoscopic or other minimally invasive
surgical procedures.
[0024] Still referencing FIG. 1, the surgical training device 10
includes a top cover 16 connected to and spaced apart from a base
18 by at least one leg 20. FIG. 1 shows a plurality of legs 20. The
surgical training device 10 is configured to mimic the torso of a
patient such as the abdominal region. The top cover 16 is
representative of the anterior surface of the patient and the space
between the top cover 16 and the base 18 is representative of an
interior of the patient or body cavity where organs reside. The
surgical trainer 10 is a useful tool for teaching, practicing and
demonstrating various surgical procedures and their related
instruments in simulation of a patient undergoing a surgical
procedure. Surgical instruments are inserted into the cavity 12
through the tissue simulation region 14 as well as through
pre-established apertures 22 in the top cover 16. Various tools and
techniques may be used to penetrate the top cover 16 to perform
mock procedures on model organs placed between the top cover 16 and
the base 18. The base 18 includes a model-receiving area 24 or tray
for staging or holding a simulated tissue model or live tissue. The
model-receiving area 24 of the base 18 includes frame-like elements
for holding the model (not shown) in place. To help retain the
simulated tissue model or live organs on the base 18, a clip
attached to a retractable wire is provided at locations 26. The
retractable wire is extended and then clipped to hold the tissue
model in position substantially beneath the tissue simulation
region 14. Other means for retaining the tissue model include a
patch of hook-and-loop type fastening material (VELCRO.RTM.)
affixed to the base 18 in the model receiving area 24 such that it
is removably connectable to a complementary piece of hook-and-loop
type fastening material (VELCRO.RTM.) affixed to the model.
[0025] A video display monitor 28 that is hinged to the top cover
16 is shown in a closed orientation in FIG. 1. The video monitor 28
is connectable to a variety of visual systems for delivering an
image to the monitor. For example, a laparoscope inserted through
one of the pre-established apertures 22 or a webcam located in the
cavity and used to observe the simulated procedure can be connected
to the video monitor 28 and/or a mobile computing device to provide
an image to the user. Also, audio recording or delivery means may
also be provided and integrated with the trainer 10 to provide
audio and visual capabilities. Means for connecting a portable
memory storage device such as a flash drive, smart phone, digital
audio or video player, or other digital mobile device is also
provided, to record training procedures and/or play back
pre-recorded videos on the monitor for demonstration purposes. Of
course, connection means for providing an audio visual output to a
larger screen other than the monitor is provided. In another
variation, the top cover 10 does not include a video display but
includes means for supporting a laptop computer, a mobile digital
device or tablet such as an IPAD.RTM. and connecting it by wire or
wirelessly to the trainer.
[0026] When assembled, the top cover 16 is positioned directly
above the base 18 with the legs 20 located substantially around the
periphery and interconnected between the top cover 16 and base 18.
The top cover 16 and base 18 are substantially the same shape and
size and have substantially the same peripheral outline. The
internal cavity is partially or entirely obscured from view. The
top cover 16 is removable from the legs 20 which in turn are
removable or collapsible via hinges or the like with respect to the
base 18. Therefore, the unassembled trainer 10 has a reduced height
that makes for easier portability. In essence, the surgical trainer
10 provides a simulated body cavity 12 that is obscured from the
user. The body cavity 12 is configured to receive at least one
surgical model accessible via at least one tissue simulation region
14 and/or apertures 22 in the top cover 16 through which the user
may access the models to practice laparoscopic or endoscopic
minimally invasive surgical techniques.
[0027] A cuff model 30 according to the present invention is shown
in FIG. 2. The cuff model 30 is configured to be placed inside the
surgical training device 10 described above or other surgical
trainer similar to the one described above. The cuff model 30
includes a base 32, a connector 34, a cuff-holder 36 and at least
one cuff 38. FIG. 2 illustrates two cuffs 38a and 38b arranged such
that one cuff 38b is placed over another cuff 38a. FIG. 3
illustrates the cuff model 30 with the cuffs 38 removed showing the
base 32, connector 34 and cuff holder 36.
[0028] The base 32 of the cuff model 30 is a platform that serves
as a bottom support for the rest of the model 30 and it is sized
and configured such that the model does not tip over. The platform
is made of any material such as metal or plastic. The base 32 is of
sufficient heft to maintain the stability of the model 30 in the
upright position while being manipulated by a user. The model 30 is
sized and configured to be placed into the body cavity 12 of the
surgical trainer 10 in the location of the model receiving area 24.
The underside of the base 32 is provided with means to affix the
cuff model 30 inside the surgical trainer 10. Such means to affix
the cuff model 30 inside the trainer 10 include but are not limited
to adhesive, suction cup, snap-fit, magnet, and a hook-and-loop
type fastener material attached to the bottom surface of the base
32 and configured to connect with a complementary hook-and-loop
type fastener material or adhesive attached to the base 18 of the
surgical trainer 30.
[0029] Still referencing FIGS. 2 and 3, connected to the base 32 of
the cuff model 30 is a connector 34. The connector 34 is an
elongate arm that separates the cuff holder 36 from the base 32. At
a first end, the connector 34 is connected to the base 32 such that
it extends vertically upwardly from the base. At a second end of
the connector 34, the connector 34 is connected to the cuff holder
36. The connector 34 is a flexible gooseneck such that the position
of the cuff holder 36 can be adjusted with the position being
maintained by the gooseneck connector 34 following the adjustment.
In one variation, the connector 34 is flexible and in another
variation the connector 34 is rigid. In yet another variation that
is shown in FIG. 4, a rigid connector 34 is connected to the base
32 via a ball joint or swivel bearing 40 such that the rigid
connector 34 is movable in manner that permits adjustment yet
maintains the cuff holder 36 in the new position following the
adjustment. The connector 34 may be rotatable with respect to the
base 32. Also, the connector 34 may be flimsy such that it does not
hold an adjusted position but has to be maintained in the desired
position by the user. Of course, the connector may be connected
directly to the base 18 of the trainer 10.
[0030] Another variation of the cuff model 30 is shown in FIG. 5 in
which the base 32 includes a vertical portion 42. From the
upstanding vertical portion 42, the connector 34 extends
substantially laterally as shown in FIG. 5. The connector 34 is a
flexible gooseneck-type connector 32 or a rigid connector 34 that
supports the cuff holder 36. FIG. 5 shows the cuff holder 36
without one or more cuffs 38. In this variation, the connector 34
may also be rigid or flexible and capable of maintaining its
position relative to the base or not. Also, a swivel bearing may be
employed to connect the connector to the vertical portion 42.
[0031] Turning now to FIG. 6, there is shown another variation in
which the base 32 includes a vertical portion 42 extending
upwardly. From the upstanding vertical portion 42, the cuff holder
36 is attached directly to the base 32. In this variation, there is
no connector 34 that would impart flexibility or movability to the
cuff holder 36. The cuff holder 34 is attached with adhesive or
other fastener means directly to the base 32. In another variation,
as shown in FIG. 6, the connector is an elongate pin or the like
onto which the cuff holder 36 is mounted in a fixed or movable
relationship in which the cuff holder 36 angulates, rotates or
moves relative to the base 32. Of course, the cuff holder 36 can be
attached to the horizontal portion of the base 32 without the
connector 34. Without the connector 34, the cuff holder 36 may be
connected to the base 32 at an angle with respect to the base
32.
[0032] The cuff holder 36 is a structure configured to hold the
cuff 38 in a desired configuration. The cuff holder 36 is connected
to the connector 34 or directly to the base 32 as described above.
The cuff holder 36 serves as a mount for one or more cuffs 38 to be
placed over the cuff holder 36. In one variation, the cuff holder
36 is cylindrical in shape and is made of any suitable material
such as plastic or metal in solid or hollow construction. The
proximal end of the cuff holder 36 that connects to the connector
34 may include connecting means or socket for receiving and
attaching to the connector 34. The cuff holder 36 may attach to the
connector 34 such that the cuff holder 36 rotates, angulates,
twists or moves with respect to the connector 34. In one variation,
the cuff holder 36 is not circular in cross-section but has an
elliptical cross-section. In one variation, the major axis of the
elliptical cross-section of the cuff holder 36 is approximately
1.75 inches and the minor axis is approximately 1.0 inch. In
another variation, the major axis of the elliptical cross-section
of the cuff holder 36 is approximately 2.25 inches and the minor
axis is approximately 1.5 inches. The cuff holder 36 can have any
cross-sectional shape including any closed curve or polygonal shape
depending upon the surgical skill to be practiced and the purpose
of the tissue simulation. The cuff holder 36 is approximately 1.5
inches long. Furthermore, the cuff holder 36 is removable from the
base or connector 34 and interchangeable with another cuff holder
36 having a different length or cross-sectional shape or size. The
cuff holder 36 may be connected by any removable means such as
snap-fit, friction-fit, or threaded onto the connector 34.
[0033] Turning now to FIG. 7, a typical cuff or sleeve 38 of the
present invention is shown. The cuff 38 has a tubular form having a
central lumen interconnecting an open proximal end and an open
distal end. At least a portion of the distal end of the cuff 38 is
resilient and compressible such that the perimeter of the distal
end can be pressed together or drawn into juxtaposition by the user
employing clamps or sutures or staples or simply by pressing the
end to close the lumen and distal opening. The material of the cuff
38 is flexible and preferably made of polymeric material. The cuff
may include a four-way stretch, porous fabric material such as
nylon with a silicone over mold formed into a hollow cylindrical,
tubular shape. The thickness of the cuff 38 is approximately 1-5 mm
and the cuff 38 is approximately 2-4 inches in length and could be
longer such as up to 6 inches. Generally, the cuff 38 is longer in
length than the cuff holder 36 such that at least a portion of the
cuff 38 extends beyond the free distal end 44 of the cuff holder
36. Since the material of the cuff 38 is stretchable, it is sized
to stretch over the cuff holder 36. Hence, the diameter of the cuff
38 closely matches the diameter of the cuff holder 36 with the cuff
holder 36 being the same or slightly larger in diameter than the
diameter of the cuff 38 such that the cuff 38 is placed in tension
when stretched over the cuff holder 38 and thereby held removably
connected to the cuff holder 38. A cuff 38 having an elliptical
cross-section is also within the scope of the present invention.
The major axis of the elliptical cross-section of the cuff 38 is
approximately 1.75 inches and the minor axis is approximately 1.0
inch. In another variation, the major axis of the elliptical
cross-section of the cuff 38 is approximately 2.25 inches and the
minor axis is approximately 1.5 inches. A cuff 38 having an
elliptical cross-section may be placed over a cuff holder 36 that
has a circular cross-section or an elliptical cross-section. The
silicone over mold provides a realistic tissue feel and the
embedded fabric material of the cuff prevents tearing of the
material which is especially important as the user practices
pulling sutures through the cuff 38. The cuff 38 may be made of any
polymer, including silicone or a thermoplastic elastomer, styrenic
block copolymer such as KRATON.RTM. or hydrogel. The cuff 38 is
dyed any color, typically white or pink, to mimic real tissue.
Where two cuffs 38 are employed for practicing, a first cuff 38a is
selected as white and placed over the cuff holder 36 and the second
cuff 38b is red or pink in color and placed over the first cuff 38a
such that the first cuff 38a is inside the second cuff 38b. The use
of two colors mimics certain real tissues of the human body and
also allows for contrast and distinction between the two cuff
layers. The outside layer being red or pink does not get washed out
by light when viewed via a laparoscopic camera on a monitor. Since
it is red or pink it does not reflect the light while viewed under
the scope as a white layer would. Any color can be employed for the
two layers so long as contrast is created between the layers when
viewed via a monitor. Hence, one layer is a light colored layer,
preferably the inner cuff layer and the outer cuff layer is
preferably made of a darker color. Contrasting layers is not
required. Also, instead of using two cuffs 38a and 38b, a single
cuff 38 can be formed to mimic a two cuffs, one placed inside the
other, and the single cuff can be dyed with a gradient of color
from dark to light going from outside to the inside of the cuff 38.
The distal end of one or more cuffs 38a, 38b may include an uneven
edge for increased difficulty in suturing the ends together
requiring the practitioner to vary the suture lengths, pull and
stretch the cuffs accordingly. The uneven distal ends of the cuffs
38 may include scallops that extend inwardly from the distal end of
the cuff to create a wavy pattern at the distal end. When two cuffs
38a, 38b are employed, one on top of the other, their respective
distal ends are uneven also with respect to each other. For
example, one cuff may have a straight edge and the other cuff may
have an uneven distal edge or both cuffs may have uneven distal
edges. For a simple suturing exercise, the distal ends are
even.
[0034] In use, a single cuff 38 that is placed in tension and
stretched over the cuff holder 36. The cuff is moved towards the
connector 34 until a desirable amount or length of cuff 38 material
overhangs or extends beyond the distal or free end 44 of the cuff
holder 36. The cuff 38 extending beyond the free end 44 of the cuff
holder 36 is shown in FIGS. 2 and 4. The user practices closing the
open end of the cylindrical cuff 38 that overhangs the distal end
44 of the cuff holder 36 with sutures or staples. The overhanging
portion of the cuff 38 advantageously mimics certain real tissue
structures such as a resected bowel and the vaginal opening and
allows the user to practice whatever suturing technique they would
like to practice in the laparoscopic or endoscopic minimally
invasive procedure in which the cuff model 30 is hidden from direct
visualization by the surgeon having been placed inside the surgical
trainer 10. The cuff 38 may be any size and diameter depending upon
whether the simulation is for a large intestine, small intestine,
colon, vaginal cuff, or vascular structure.
[0035] For example, a surgeon can practice the suturing necessary
to be performed following a laparoscopic hysterectomy. Laparoscopic
gynecological surgeons perform total laparoscopic hysterectomies in
which the uterus is removed requiring closure of the vaginal vault.
The present cuff model 30, and in particular, the overhang portion
of the cuff 38, mimics the entry to the vaginal vault that needs to
be closed by suturing following a hysterectomy. The surgeon can
thus use the model to practice suturing in this special
procedure.
[0036] Especially realistic is the use of two cylindrical cuffs 38a
and 38b to mimic the vaginal vault which comprises of two tissue
layers, an inner layer and an outer layer which are sutured closed.
The inner cuff 38a may represent a mucosa layer and the outer cuff
38b may represent the fascia or peritoneum for practicing surgical
skills. In one variation, two cuffs 38a and 38b are placed over the
cuff holder 36 in tension. In one variation, a first cuff 38a
having a white color is stretched slightly and pulled onto and over
the cuff holder 36 leaving an overhang portion described above.
Then a second cuff 38b that is red or pink in color is place over
the first cuff 38a by stretching it slightly and pulling it over
the first cuff 38 and onto the cuff holder 36. Alternatively, a
first white cuff 38a is placed inside a second red or pink cuff 38b
and then both are simultaneously stretched slightly and then pulled
over the cuff holder 36 simultaneously. The stretching of the cuffs
38a and 38b over the cuff holder 36 is what holds the cuff layer
38a and 38b in place and movably connected to the cuff holder 36.
In another variation, the two cuffs 38a and 38b are glued together
with or without a setback at the distal end of the top layer 38b.
The adhesive is applied proximally from the distal ends such that
the two layers 38a, 38b are separable from each other at the distal
end. The overhang portion includes an inner cuff 38a and an outer
cuff 38b and their distal ends extending beyond the distal end 44
of the cuff holder 36 by a distance of approximately 0.25 inches to
1.0 inches. The length of the overhang portion may vary and is
selectable by the user by moving the cuff 38 along the cuff holder
36 to adjust the length of the overhang. The cuff holder 36 is
configured to maintain the overhang portion of a cuff 38 of
substantially the same cross-sectional shape as the cuff holder 36
in a substantially open shape. For example, a cuff 38 having a
circular cross-section when mounted on a cuff holder 38 having a
circular cross-section will have an overhang portion that retains
an opening that is substantially circular at the distal end. If a
more elliptically-shaped overhang portion is desired an
elliptically shaped cuff can be mounted on a cuff holder having an
elliptical cross-section. The second or outer cuff 38b is placed
over the first cuff 38a such that the distal end of the second or
outer cuff 38b is set back approximately 1/3 cm from the distal end
of the first or inner cuff 38a as shown in FIGS. 2 and 4. An
example of a two cuff construct includes a tubular first cuff 38a
having a substantially elliptical cross-section with a major inner
axis dimension of approximately 1.75 inches and a minor inner axis
dimension of approximately 0.40 inches with a thickness of
approximately 0.125 inches and approximately 3.0 inches long. The
second or outer cuff 38b is also tubular having an elliptical
cross-section and a thickness of approximately 0.05-0.08 inches and
an overall length of approximately 2.80 inches. The outer cuff 38b
has a major inner axis of approximately 2.0 inches and a minor
inner axis dimension of approximately 0.66 inches. The distal end
of the first cuff 38a extends approximately 0.3-0.5 cm beyond the
distal end of the second cuff 38b. The shorter length of the second
cuff 38b forces the practitioner to pull the distal end of the
second cuff 38b into alignment with the distal end of the first
cuff 38a for suturing both ends together allowing the user to
practice keeping the outer layer in tension while placing the
suture. Also, the outer layer 38b is thinner than the inner layer
38b forcing the user to regulate the tension appropriately so that
the suture does not pull through the cuff material. Hence, it is
advantageous to have two layers that are not of the same
thickness.
[0037] Other than color, diameter and length, the inner and outer
cuff layers 38a and 38b are substantially identical made with the
same materials or alternatively of different materials. For
example, one or more of the layers may omit the mesh support. Also,
the thicknesses of the layers may be the same (approximately 1/16
inches thick). If cuffs 38 of circular cross-sections are employed,
the inner or first cuff 38a has a diameter of approximately 1.0
inch and the outer or second cuff 38b has a diameter of
approximately 1.125 inches. The cuff holder 36 is approximately
1.125 inches in diameter which is the same diameter of the outer or
second cuff 38b. With at least one cuff 38 on the cuff holder 36,
the cuff holder 36 can be articulated using the flexible connector
34 to position the proximal open end of the cuffs 38 that suits the
clinician. Hence, the clinician can practice manipulating the
position of the cuff holder 36 to adequately suit his needs. Then,
the user sutures or staples the cuff closed. The position of the
cuff can be manipulated during the closure by the clinician or
assistant in order to obtain the optimal position for the surgeon
to perform suturing. Hence, the articulating connector arm 34
allows for different positions or adjustments of the cuff 38.
[0038] With the overhang portion available for practicing suturing,
the user can practice making individual stitches each closed by an
intracorporeal or extracorporeal knot (interrupted suture) or a
running stitch which has a knot at the beginning and end but no
knots in the middle. Additionally, the user can practice using a
barbed suture that does not require knots of any type and runs the
length of the open end of the overhanging cuff. Most often the user
will close both inner and outer cuff layers 38a and 38b at the same
time or they may practice closing the first or inner cuff 38a layer
first and then closing the second or outer cuff 38b layer. After
the stitches are completed, the surgeon can also practice
performing a leak test to see if the suture cuff has been
adequately closed by pouring water into the inner cuff to see if
the water holds inside the cuff. In the leak test, after the layers
are sutured closed, the user would remove the cuff from the
cuff-holder and pour water in the open end of the cuff to see if
the sutured end leaks. The water should remain contained within the
cuff. If leaking is observed the suturing requires improvement. The
same leak test may be performed after the cuff is stapled.
[0039] Following a closure of the at least one cuff 38 with sutures
or staples, the user can cut off the end that was sutured or
stapled removing it from the remainder of the at least one cuff and
if necessary slide the at least one cuff 38 towards the free end 44
of the cuff holder 36 to create another overhang portion or
selectably increase or adjust the length of the one or more
overhang portions to practice suturing again. This process can be
repeated until there is insufficient cuff 38 to remain stretched
onto the cuff holder 36 at which point a new cuff 38 or cuffs 38
can be placed over the cuff holder 36 for further practice. Hence,
the cuff 38 is designed as a consumable component which is
approximately 3 inches long and may be longer which allows for
multiple uses before needing a replacement. The user sutures the
cuff closed. Then, the distal portion of the cuff 38 is cut off so
that the remaining length of the cuff can be used several more
times before it needs to be replaced. Thereby, the cuff model 30
advantageously isolates the step of suturing a cylindrical opening,
in particular, the laparoscopic suturing of the vaginal cuff in a
representative model for the purpose of repeated practice.
[0040] Turning now to FIG. 8, there is shown another variation of
the cuff model 50 in which two cuff models 48, 49 each of the like
described above are positioned substantially opposite from each
other. The cuff model 50 is configured to be placed in the surgical
training device 10 described above and shown in FIG. 1 or other
surgical trainer similar to the one described above. The cuff model
50 includes two cuff models 48, 49 connected to a base 52 in
substantially opposite relation to each other. The first cuff model
48 includes a first connector 54 connected to the base 52 at one
end and to a first cuff holder 58 at the other end. The second cuff
model 49 includes a second connector 56 connected to the base 52 at
one end and to a second cuff holder 60 at the other end. At least
one cuff 62 is placed on each cuff holder 58, 60 as shown in FIG. 9
which illustrates cuffs 62a and 62b placed on the first and second
cuff holders 58, 60, respectively.
[0041] The base 52 of the cuff model 50 is a platform that serves
as a bottom support for the both cuff models 48, 49 and it is sized
and configured such that the model does not tip over. The platform
is made of any material such as metal or plastic. The base 52 is of
sufficient heft to maintain the stability of the model 50 in the
upright position while being manipulated by a user. The model 50 is
sized and configured to be placed into the body cavity 12 of the
surgical trainer 10 in the location of the model receiving area 24.
The underside of the base 52 is provided with means to affix the
cuff model 50 inside the surgical trainer 10. Such means to affix
the cuff model 50 inside the trainer 10 include but are not limited
to adhesive, suction cup, magnet, snap-fit, and a hook-and-loop
type fastener material attached to the bottom surface of the base
52 and configured to connect with a complementary hook-and-loop
type fastener material attached to the base 18 of the surgical
trainer 10.
[0042] Still referencing FIGS. 8 and 9, connected to the base 52 of
the cuff model 50 is a first connector 54 and a second connector 56
of the like described above with respect to connector 34. The
connectors 54, 56 are elongate arms that separate each cuff holder
58, 60, respectively, from the base 52. At their first ends, the
connectors 34 are connected to the base 52 such that each extends
vertically upwardly away from the base 52. At their second ends,
each connector 54, 56 is connected to the cuff holders 58, 60. Each
connector 54, 56 is a flexible gooseneck arm such that the position
of the cuff holders 58, 60 can be adjusted with the position being
maintained by the gooseneck connectors 54, 60 following the
adjustment. In one variation, at least one of the connectors 54, 56
is flexible and in another variation the connectors 54, 56 are both
rigid. In yet another variation, rigid connectors 54, 56 are
connected to the base 52 via a ball joint or swivel bearing such as
described and shown in FIG. 4 such that the rigid connectors 54, 56
are movable in manner that permits adjustment yet maintains the
cuff holders 58, 60 in the new position following the
adjustment.
[0043] In other variations of the cuff model 50, at least one of
the connectors 54, 56 is attached to one or more vertical portions
of the base 52 as shown in FIG. 5 such that from the upstanding
vertical portion the connectors 54, 56 extend substantially
laterally toward each other and in opposition from each other. The
cuff holders 58, 60 may be connected directly to the base 52 and in
another variation, one or more of the cuff holders 58, 60 are
connected directly the base 18 of the trainer 10 and yet in another
variation no cuff holders 58, 60 or connectors 54, 56 are employed
and the cuffs are connected to base 18 of the trainer 10 with clips
26 connected to the base. The connectors 54, 56 are flexible
gooseneck-type connectors or rigid connectors that support cuff
holders 58, 60, respectively. FIG. 8 shows cuff holders 58, 60
without one or more cuffs 62.
[0044] In another variation of the cuff model 50, the base 52
includes two opposed vertical portions extending upwardly of the
like shown in FIG. 6. From the upstanding vertical portion, the
cuff holders 36 are attached directly to the vertical portions and
extend laterally toward each other and into opposition from each
other. The cuff holders 58, 60 are attached with adhesive or other
fastener means directly to the base 52. In another variation of the
cuff model 50, the connectors 54, 56 are elongate pins onto which
the cuff holders 58, 60 are mounted in a movable or fixed
relationship. Of course, the cuff holders 58, 60 can be attached to
the horizontal portion of the base 52 without the connectors 54,
56.
[0045] The cuff holders 58, 60 are each configured to hold at least
one cuff or sleeve 62 in a desired configuration. The cuff holder
58 is connected to the connector 54 or directly to the base 52 as
described above. Cuff holder 60 is connected to connector 56 or
directly to the base 52. The cuff holders 58, 60 serve as a mounts
for one or more cuffs 62 to be placed on each cuff holder 58, 60.
In one variation, the cuff holders 58, 60 are cylindrical in shape
and are made of any suitable material such as plastic or metal in
solid or hollow construction. The end of the cuff holder that
connects to the connector may include connecting means or socket
for receiving and attaching to the connector. In one variation, the
cuff holder is not circular in cross-section but has an elliptical
cross-section. The cuff holders can have any cross-sectional shape
including any closed curve or polygonal shape. Each of the cuff
holders 58, 60 are approximately 1.5 inches long.
[0046] The typical cuff 62 used for cuff model 50 is the same as
used for cuff model 30 and shown and described in FIG. 7. The cuff
material includes a four-way stretch, porous fabric material such
as nylon or other mesh with a silicone over mold formed into a
hollow cylindrical, tubular shape. The thickness of the cuff 62 is
approximately 1-5 mm and the cuff 62 is approximately 3-4 inches in
length and could be longer such as up to 6 inches. To simulate the
thickness of an intestine, the cuff is larger approximately 1/8
inches thick. The cuff 62 is generally longer in length than the
cuff holders 58, 60 such that at least a portion of the cuffs 62a,
62b extends beyond the free ends 44a, 44b of the cuff holders 58,
60, respectively, as seen in FIG. 9. Since the material of the
cuffs 62a, 62b is stretchable, it is sized to stretch over cuff
holders 58, 60, respectively. Hence, the diameter of the cuffs 62a,
62b closely match the diameter of the cuff holders 58, 60,
respectively, with the cuff holders 58, 60 being the same or
slightly larger in diameter than the diameter of the cuffs 62a,
62b, respectively, such that the cuffs 62a, 62b are placed in
tension stretched over the cuff holders 58, 60. The silicone over
mold provides a realistic tissue feel and the fabric material of
the cuff prevents tearing of the material which is especially
important as the user practices pulling sutures through the cuff
62. The cuff 62 is dyed any color, typically white or pink, to
mimic real tissue. Where four cuffs 62 are employed for practicing
particularized suturing, a first cuffs 62a and 62b are selected as
white and placed over the cuff holders 58, 60, respectively, and
the second cuffs 62c, 62d are selected as red or pink in color and
placed over the first cuffs 62a, 62b, respectively. The use of two
colors mimics certain real tissues of the human body and also
allows for contrast and distinction between the two cuff layers.
The outside layer being red or pink does not get washed out by
light when viewed via a laparoscopic camera on a monitor. Since it
is red or pink it does not reflect the light while viewed under the
scope as a white layer would. Any realistic color can be employed
for the two layers. Also, one layer may be formed to resemble a
two-layer model and dyed with a gradient of color from darker at
the outer surface to lighter color at the inner surface. The cuffs
62a, 62b, 62c, 62d may have a circular or elliptical cross-section
and may be placed over cuff holders 58, 60 having circular or
elliptical cross-sections.
[0047] In use, a single cuff 62a that is cylindrical in shape
having a circular or elliptical cross-section is placed in tension,
stretched over the first cuff holder 58 which may have a circular
or elliptical cross-section. The cuff 62a is moved towards the
connector 48 until a desirable amount of cuff 62a material
overhangs or extends beyond the distal or free end 44a of the cuff
holder 58. A second single cuff 62b that is cylindrical in shape is
placed in tension, stretched over the second cuff holder 60. The
cuff 62b is moved towards the connector 56 until a desirable amount
of cuff 62b material overhangs or extends beyond the distal or free
end 44b of the cuff holder 60. The user practices connecting the
two overhanging portions of cylindrical cuff material whose distal
open end are in juxtaposition or adjacent to each other. Connecting
the two adjacent cylindrical overhanging portions of cuffs 62a and
62b is performed by repeatedly passing one or more suture 68
through one cuff 62a and the other cuff 62b to connect them
together. The skill requires keeping one or more of the cuffs 62a,
62b under some tension so that ends can be sutured yet not with too
much tension so that sutures do not tear through the cuffs. The
overhang portion of the cuffs 62a, 62b advantageously mimics
certain real tissue structures such as a portion of the bowel and
allows the user to practice whatever suturing technique they would
like to practice in the laparoscopic or endoscopic minimally
invasive procedure in which the cuff model 50 is hidden from direct
visualization by the surgeon having been placed inside the surgical
trainer 10. Hence, this cuff model 50 includes two open cylindrical
portions of cuff material that are held in proximity on respective
cuff holders. The cuff holders can be adjusted to increase or
decrease the difficulty in suturing the free ends together. For
example, one connector can be twisted or directed to one side to
offset one cuff holder from the opposed cuff holder or otherwise
place the longitudinal axis of one cuff holder at an angle to the
longitudinal axis of the other cuff holder to thereby offset or
angulate the mounted cuffs from each other as described above with
respect to FIGS. 8 and 9. At least one of the connectors 54, 56
with attached cuff holders 58, 60 may be removable from the base 52
for placement inside holes formed in the base 52 at different
locations. The arrangement of holes in the base 52 allows for
different angulations of the cuffs with respect to each other.
Hence, the model 50 is ideal for practicing different types of
anastomoses including end-to-end anastomosis as shown in FIG. 9 in
which the ends of the cuffs are positioned approximately 1.5 inches
apart and the ends of the holders are approximately 3.5 inches
apart, side-to-side anastomosis in which the longitudinal axes of
the cuffs 62a, 62b together with the cuff holders 58, 60 are
oriented substantially parallel to each other by placing the
connectors 54, 56 into adjacent holes in the base such that the
cuffs are in juxtaposition, and side-to-end anastomosis in which
the longitudinal axes of the cuffs 62, 62b together with the cuff
holders 58, 60 are oriented substantially perpendicularly to each
other by placing the connectors 54, 56 into appropriate holes in
the base 52 such that the end of one cuff is in juxtaposition to
the sidewall of the other cuff. Of course, two bases may be
employed and moved into proper orientations for practicing
different types of anastomoses. Also, the connectors may be flimsy
goosenecks that require propping or constant adjustment to simulate
real tissue that requires the user to support using an additional
instrument or procedure.
[0048] Turning now to FIG. 10, cuff model 50 can also be used with
four cylindrical cuffs 62a, 62b, 62c, and 62d to create a construct
having two layers of polymeric mesh material formed by cuffs 62a,
62c on one cuff holder 58 and two layers of polymeric mesh material
formed by cuffs 62b, 62d on the other opposed cuff holder 60. In
such a configuration, an inner layer and an outer layer are
provided which are both sutured closed. In one variation, two cuffs
62a and 62c are placed over the cuff holder 58 in tension and two
cuffs 62b and 62d are placed over the cuff holder 60 in tension. In
one variation, first cuffs 62a, 62b are white in color and
stretched slightly and pulled onto and over the cuff holders 58,
60, respectively, leaving oppositely disposed overhang portions
distal to the cuff holder distal ends 44a, 44b, respectively. Then
second cuffs 62c, 62d that are red or pink in color are placed over
the first cuffs 62a, 62b, respectively, by stretching it slightly
and pulling it over the first cuffs 62a, 62b and onto the cuff
holders 58, 60, respectively. Alternatively, a first white cuff 62a
is placed inside a second red or pink cuff 62c and then both are
simultaneously stretched slightly and then pulled over the first
cuff holder 58 simultaneously. The stretching of one or more cuffs
over the cuff holder is what holds the one or more cuff layer in
place and movably connected to the cuff holder. The overhang
portion includes an inner cuff 62a and an outer cuff 62b on one
cuff holder 58 and an overhang portion of an inner cuff 62b and an
outer cuff 62d on the other cuff holder 60 with the distal
overhanging portions that extend away from the free ends 44a, 44b
of the cuff holders 58, 60 meeting in juxtaposition or adjacent to
each other and in some variations separated by a distance across
which suturing is practiced. The diameter of the inner and outer
cuff layers is substantially identical and they are made with the
same materials and approximately the same thickness (approximately
1/16 inches thick). In one variation, the outer cuff is slightly
thinner than the inner cuff. The inner or first cuffs 62a, 62b have
a diameter of approximately 1.0 inch and the outer or second cuffs
62c, 62d have a diameter of approximately 1.125 inches. The cuff
holders 58, 60 are approximately 1.125 inches in diameter. With at
least one cuff 62 on the cuff holders 58, 60, the cuff holders 58,
60 can be articulated using the flexible connector 54, 56 to
position the distal open ends of the cuffs 62 in a manner that
suits the clinician to practice the different types of anastomosis
mentioned above. The diameter of the cuffs may vary from
approximately 1.0 mm for vascular anastomosis and up to
approximately 65 mm for gastric anastomosis with correspondingly
sized cuff holders to hold the different cuffs. The cuff holders
may interchangeable with the connectors and bases to fit different
cuffs. The clinician can practice manipulating the position of the
cuff holders 58, 60 to adequately suit his needs. Then, the user
sutures the cuffs together. The position of the cuff can be
manipulated during the closure by the clinician or assistant in
order to obtain the optimal position for the surgeon to perform
suturing. Hence, the articulating connector arms 54, 56 allow for
different positions of the cuffs 62.
[0049] Following a connection of the at least one cuff 62 to at
least one opposed cuff with sutures, the user can cut the sutured
portion out removing it from the remainder of the remaining tube
leaving two tubular pieces mounted on the cuff holders. The
remaining tubular pieces can be moved by sliding on the cuffs
towards the free ends 44a, 44b of the cuff holders to create
overhang portions of sufficient length to practice suturing the two
adjacent tubular cuffs together again. This process can be repeated
until there is insufficient cuff remaining to be held stretched
onto the cuff holders at which point new cuffs can be placed over
the cuff holders for further practice. Hence, the cuffs 62 are
designed as consumable components which are approximately 3 inches
long and may be longer which allows for multiple uses before
needing a replacement. A kit comprising of a number of cuffs may be
sold to accompany an already purchased cuff holder, connector and
base which may also be included in the kit. The user sutures the
overhanging cuffs together. Then, the sutured portion of the cuff
is cut out so that the remaining length of the cuff can be used
several more times before it needs to be replaced. Thereby, the
cuff model 50 advantageously isolates the step of suturing a
tubular opening, in particular, the laparoscopic suturing of two
tubular structures together in a representative model for the
purpose of repeated practice.
[0050] Cuff model 50 is particularly useful for practicing
anastomosis which is the connection of two structures. It refers to
connections between blood vessels or between other tubular
structures such as loops of intestine. An example of surgical
anastomosis which the user can practice is when a segment of
intestine is resected and the two remaining ends are sewn or
stapled together (anastomosed), for example, in a procedure called
Roux-en-Y anastomosis. In such a set up, the model would be
employed with a singular cuff 64 that is mounted on both cuff
holders 58, 60 and spans the distance between the cuff holders 58,
60 as shown in FIG. 11. The single cuff 64 can include a fake tumor
66 attached to the cuff 64 providing visual indication to the user
of the location of the tumor by contrast coloring. The user can
then resect that portion of the simulated intestine removing it
from the cuff 64 and then manipulate the connectors 54, 56 to bring
the remaining overhang portions closer together for anastomosis
suturing or stapling the two remaining overhanging tubular portions
together. In such a variation, the cuff 64 is approximately 1/8
inch thick and 6-12 inches in length.
[0051] In a variation of the model used for the practice of
suturing a vaginal cuff after a hysterectomy, the model may further
include adjunct simulated organs and tissues. For example,
simulated adnexal tissues and peritoneum are provided with the
model in addition to simulated uterosacral ligaments and bladder.
These simulated tissues are made of silicone or other appropriate
material.
[0052] While certain embodiments have been particularly shown and
described with reference to exemplary embodiments thereof, it will
be understood by those of ordinary skill in the art that various
changes in form and details may be made therein without departing
from the spirit and scope thereof as defined by the following
claims.
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