WO2012168287A1

WO2012168287A1 - Artificial organs for surgical simulation training and method of producing artificial organs

Info

Publication number: WO2012168287A1
Application number: PCT/EP2012/060674
Authority: WO
Inventors: Malcolm Wells MACKENZIE
Original assignee: Lapskill Medical As
Priority date: 2011-06-06
Filing date: 2012-06-06
Publication date: 2012-12-13

Abstract

Ex vivo organ model is constructed of mammalian, non-human organs and tissues arranged to mimic a human uterus, cervix and optionally vagina, peritoneum, fallopian tubes and ovaries. According to one embodiment, a porcine or bovine heart is arranged inside a porcine or bovine bladder to mimic the uterus, and a cylindrical segment of tissue is arranged over the bladder opening to mimic the cervix. Additional tissues are connected to the construct to represent various ligaments and cervical structures.

Description

Artificial organs for surgical simulation training and method of producing artificial organs

Field of the invention

The present invention relates to surgical training devices and methods, in particular to the production of real tissue artificial organs for use in surgical training simulations. Background

Minimally invasive surgical training has traditionally been achieved through progressive mentored performance of actual surgeries

on actual patients. For the purpose of improving surgical skills within formal medical education programs and improving surgical technique training for mature physician/surgeons, simulation of minimally invasive surgical procedures has employed a variety of "tissue" models eg. human embalmed and fresh cadaveric, live anesthetized porcine and ovine preparations, total and partial porcine explants, as well as surgical model constructs utilizing wholly synthetic materials. Non-physical models include computer based "virtual" constructs. Measures of "similarity" of the various simulation models to actual surgery and how the performance of tasks on these simulation models prepares the operator for the real surgical procedure in real settings include "face", "construct" and "predictive" validity as well as the concept of "haptics".

Prior known surgical simulation models suffer from various

disadvantages, namely known models are expensive, do not provide a realistic feel or responsiveness to surgical tool manipulation

(haptics) - including all energy and cutting systems - nor

adequately visually mimic the real anatomy (face validity) . Lastly, while a few models promote a skill development that predicts similar performance on other simulation models (construct validity) none have demonstrated the development of skill levels that translate to skills necessary for the performance of actual surgery (predictive validity) . No synthetic models support the use of surgical energy systems. No computer simulation models and few synthetic models provide for appropriate haptics. Current non-human biologic tissue models with often unrecognizably distant homology to human organ tissue commonly lack face validity and are very expensive. Construct validity has been demonstrated only in task based synthetic models. No model boasts predictive validity. Current human cadaveric tissue models either prohibit use of energy systems, require significant

logistical effort are prohibitively expensive or for the most part are least amenable to laparoscopic or endoscopic manipulation.

Summary of the invention

This novel concept involves the construction and presentation of "real tissue models" for high fidelity surgical simulation

training. These "real tissue models" (RTMs) , constructed out of meat industry refuse, are presented in a form that recreates the form, orientation and the conditions of human surgical anatomy allowing for the performance of surgical procedures. Depending upon the surgical procedural training desired, the RTM can be

constructed/modified to accurately mimic normal and pathologically altered human anatomy. It is this fabrication of RTMs homologous to normal and pathologically altered pelvic anatomy that provides conditions supporting high fidelity surgical simulation training. The present invention overcomes the disadvantages of the prior art by providing both a method of production and product for surgical training in the form of an endoscopic/laparoscopic surgical

simulation model utilizing prepared mammalian tissue explants from the meat industry selectively harvested and constructed in various realistic configurations. These fabricated models or tissue

"cassettes" are constructed to closely mimic the great variety of normal and abnormal human anatomy. Such tissue cassettes may be vacuum packed and frozen indefinitely awaiting future use. On thawing, the tissue cassette is then placed within a combination laparoscopic/hysteroscopic "box" trainer, allowing the performance of standard surgical procedures utilizing standard instruments, including standard surgical energy systems, and providing for the full measure of validity and haptics.

Once operated on, a used tissue cassette can be easily replaced with a new one, allowing for repetitive performance of a given operation or procedure. Tissue model cassettes are constructed to

recapitulate human anatomic orientation, to mimic tissue consistency with functionality that can include critical vascular perfusion. Custom construction of tissue cassettes provides for models that also mimic pathologically altered human anatomy. The variety

of tissue model cassettes, not limited to the representative models presented here, mirrors the full range of surgical pathologic conditions that are the object of gynaecologic, urologic and general surgical training and the focus of such surgical practice.

Brief description of the drawings

Figures 1-14 illustrate the steps for preparing a basic "Uterus and Cervix" prep model according to the invention.

Figures 15-28 illustrate the steps for preparing a basic Laparoscopy "Full Pelvic Model" according to the invention.

Figures 29-46 illustrate the steps for preparing a basic

Hysteroscopy "Uterus and Cervix" Model according to the invention. Detailed description

Specific embodiments of the invention will be described in detail. It is to be understood that the specific examples are intended to represent preferred embodiments, and not to be limiting to the scope of the inventions. The various non-human organs and tissues utilized are exemplary, and alternative organs can be selected so long as they provide similar anatomical representations.

Construction of Biologic Tissue Models

note: fabricated simulation "organs" are identified by quotation marks - eg. "cervix" - whereas the actual mammalian organ used to construct the simulation models are presented with no such

identifier - eg. Porcine vagina.

1. Basic "Uterus and Cervix" Model Materials : Porcine/ovine/bovine bladder with attached maximal full length ureters - can be cleared of attached mesenteric/peritoneal strands - irrigated and dilated by filling with water. Makes "uterine" and "cervical serosal" surface and can make "endometrial" surface (see basic hysteroscopy model) .

Bovine (large) /Porcine (medium) /Ovine (small) heart - great vessels trimmed down to the base and heart muscle sculpted and oversewn as required to form desired shape/contour or filled with tissue to change consistency. This makes the "uterine corpus" in form and substance.

Porcine upper vagina - an approximately 6cm length of vagina

excised at the base of the cervix Alternatively, an approximately 6cm length of Porcine/Bovine/Ovine esophagus muscularis stripped of its endothelium. This makes the "cervix" in form and substance. Additional supplies: 3-0 Plain gut suture with needle,

transglutaminase powder, cyanoacrylate, sandpaper, surgical

instruments.

Tissue Prep:

Wash/irrigate/soak tissue explants in Bromide solution - sufficient quantity of coarse commercial grade Bromide in boiling water to achieve super saturated solution. Cool to room temperature and filter. Dilute solution with water to 1:50 concentration. May use as bromide bath for bactericidal purposes especially for intra- bladder irrigation. Bromide solution must be fully washed off prior to model construction.

Model Assembly: a) Bladder 10 having ureter 12, urethra 14 and light mesenteric tissue 16 is trimmed as shown in Figs 1 and 2. Invert bladder in the direction of the arrows shown in Fig 2 inside out and rinse with water. As shown in Fig 3, the anatomic inner surface 18, and the anatomic exterior surface 20 are now reversed.

b) As shown in Fig 4, roughen surface of the bladder by lightly

"scouring" with sandpaper 22 to achieve a roughened surface 24. c) Sculpt the heart 26 to a desired size and shape as illustrated in Figs 5 and 6. The heart can be chosen for size or sculpted to size. Alternatives include a bovine heart untrimmed or an ovine heart trimmed to left ventricle by excising the right ventricle 28 (smaller chamber) to the ventricular septum margin 30. Trim down great vessels 32 to their base. eg. d) Excise circumferential "edge" around the apex 34 of the heart as seen in Fig 6 to create small aperture into the chamber of the heart.

e) Roughen the smooth surface of the heart by scouring with

sandpaper. Alternatively perform complete thin-layer excision of the serosal surface of the heart thus exposing the raw myocardium. This allows for an effective adhesive surface using transglutaminase. Intact dry serosal surfaces are optimally adherent using cyanoacrylate .

f) Dust the bladder surface with transglutaminase powder or apply cyanoacrylate depending upon surfaces (see e) above) .

g) Re-invert the bladder to reestablish normal anatomic

orientation as shown in Fig 7.

h) As seen in Fig 8, digitally dilate the urethra/bladder neck 14 in order to allow placement of the heart into the bladder.

Dilate slowly adding additional fingers so as to avoid tearing. The urethra may need a sagittal cut to allow for adequate opening .

i) As illustrated in Fig 9, push the heart 26 into the bladder 10 and rotate the heart such that the outlet of the bladder 14 is oriented to the apex 34 of the heart and the outlet of the heart 26 is oriented to the dome 10 of the bladder,

j) As shown in Fig 10, grasp the end(s) of the urethra/bladder

neck 14 with a surgical clamp instrument 36, and pull to stretch the bladder neck down further from the apex of the heart in order to achieve sufficient length that will be fed through and back up around a length of vagina/esophagus 38, as seen in Fig 11 and Fig. 12.

k) To achieve this, pull the stretched out length of bladder

neck/urethra 14 within and through the cylinder of vagina (or esophagus) 38. Then invert the bladder neck/urethra 14 back up around the outside of the segment of vagina 38 to the base of the heart, as shown in Fig 12. 1) As shown in Figs 13 and 14, using a needle 40 (3-0 Plain Gut suture preferable) suture the circumference of the bladder outlet/urethra into the heart muscle layer at the level of the base of the heart, making sure to include the upper edge of the vaginal cylinder and the external bladder surface. If a tear 42 occurred or a cut was necessary to create an opening of the bladder adequate to allow heart placement, this will require suture closure. Cyanoacrylate glue may be applied to the suture line. This completes the basic "uterus and cervix" model.

2. Basic Laparoscopy Full Pelvic Model: "Uterus, cervix, vagina, uterosacral ligaments, round ligaments, ovarian suspensory ligaments, infundibulopelvic ligaments, ovaries, fallopian tubes, uterine and ovarian arteries and peritoneum" model

Materials :

Basic "Uterus and Cervix" Model (as prepared above in 1.) .

Additionally,

Porcine/ovine/bovine large portion intact stomach muscularis.

Porcine/Ovine/bovine maximum length esophagus. Two (2) Porcine/Ovine distal uterus-fallopian tubes with ovaries attached .

Two (2) complete length ureters. Broad sheet of blood soaked/stained thin layer Collagen (24" x 24") Additional supplies: 2-0 or 3-0 Plain gut suture with needle, transglutaminase powder, cyanoacrylate, sandpaper, surgical

instruments . Tissue Prep:

Gastric muscularis prep: strip gastric mucosa from muscularis - tightly contracted, non-hemorrhagic, non-petechial muscularis best. Esophagus prep: strip out the endothelium from the muscularis. Cut the cylindrical esophagus in half lengthwise. One of the muscularis split halves will form the "round ligaments", the other the "ovarian suspensory ligaments" blending into the "infundibulopelvic

ligaments". The endothelium of the esophagus will form the

"uterosacral ligaments".

Ureter prep: do not clear ureters of attached fat and peritoneum. Additional fat and lacy tissue can be packed around the ureter when it is placed as the "uterine artery".

Ovary/Fallopian tube prep: excise large calibre portion of uterus leaving the smaller ends of the uterus/fallopian tube/ovary complex. Try to maintain integrity of peritoneal attachments between tube and ovary.

Wash/irrigate/soak tissue explants in water or in Bromide solution (as above in Prep #1) -

Model Assembly:

To the Basic "uterus and cervix" model 44, as seen in Fig 15, and prepared as described above, the following is added:

"vagina, uterosacral ligaments, round ligaments, adnexa, uterine/ovarian arteries, ovarian suspensory ligaments, infundibulopelvic ligaments and peritoneum."

a) As seen in Fig. 33, using the cut 6x12cm portion of gastric muscularis prep that if possible includes ruggaeted folds 94, roll and suture the long edges of the gastric muscularis prep into a cylinder 96 (see Figure 34) of approximately 12 cm circumference and 6 cm length such that the ruggaeted folds 48 (Fig. 15) 94 (Fig. 33) are on the inner surface and oriented transverse to the canal axis of the cylinder. May apply cyanoacrylate to the external closure line as well. This will become the "vagina".

b) As indicated in Fig. 15 and Fig. 42, slide the gastric

muscularis cylinder over the "cervix" and circumferentially suture the muscularis cylinder into the heart muscle immediately superior to the junction of the "cervix" and "uterus". This then completes the "uterus and cervix" 44 and "vagina" 50 as seen in Fig. 46.

c) As illustrated in Fig 16, bifold the full length of the

esophagus endothelium in half 52, firmly suture the apex of this bifold to the posterior "uterus" at midline and immediately superior to the "vaginal" attachment 50. This constitutes the "insertion" point of the "uterosacral ligaments" 54 (Fig 17) .

d) As shown in Fig 17, sharply penetrate the "uterus" 44 at the left and right supero-antero-lateral corners. As seen in Fig 18, place a long clamp 56 through one of these openings, burrow through the "uterine" walls in curvilinear fashion to exit through the corresponding opposite side of the "uterus". Grasp one end of the esophagus muscularis prep 58 and pull this back through the tunnel created by the clamp and out the other side. Orient the half-section of esophagus muscularis in a saddle-type convex down conformation as it exits the "uterus". As shown in Fig 19, securely suture the underside of the bifold esophagus muscularis to the underlying bladder and heart muscle at arrows "S" left and right, at the exit points of the esophagus muscularis - separate tacking sutures are placed at each site. This constitutes the "round ligaments" 60. e) In similar fashion, as shown in Figs 20 and 21, penetrate the "uterus" at two points slightly lower down and more posteriorly on the "uterus". Similarly pull the esophagus muscularis prep 58 through these openings. Orient the half- section of the esophagus segment convex down. At the two exit points of the bifold esophagus suture the undersides of the esophagus muscularis to the underlying bladder and heart muscle. This constitutes the "ovarian suspensory ligament" 62 (Fig. 21) in continuity then with what

constitutes the "infundibulopelvic ligament".

f) As illustrated in Fig 22, along each side of the "uterus" 44 suture tack a ureter 64 (without penetrating its lumen) at three points (A, B and C for the right and D, E and F for the left) . Orienting the ureters 64 with their small ends up and large ends down, suture points A and D are ½ cm. superior to the "vagina" 46 suture line and oriented anterolaterally on the "uterus". Suture points B and E are posterolaterally oriented on the uterus and at the

underside of the "ovarian suspensory ligament" 62. Suture points C and F are at the underside of the distal end of the "ovarian suspensory ligament" 62. With cyanoacrylate, glue the ureter to the side of the "uterus" along the length between the tacking suture points A-B and D-E. As shown in Fig 23, fold the esophagus muscularis 58 over the ureter 64, glue this such that the ureter is fully adherent to the undersurface of the overwrapping esophagus

muscularis and goes out the full length of the muscularis. This will constitute the "uterine artery" 64 ascending along the side of the "uterus" and then anastomosing with the "ovarian" blood supply ie the "ovarian artery" thus constituting along with the esophagus muscularis 58 the "infundibulopelvic ligament" 64. g) As seen in Fig 24, take the moistened collagen sheet prep 68 and lay it in "poncho" fashion over the top of the

"uterus" thus creating a bifold drape Fig 25 with an

"anterior" 68A and "posterior" leaflet 68P evident.

Central to the collagen sheet Fig 24, excise an elliptical portion 69 of sufficient aperture to allow the anterior and posterior surfaces of the "uterus" to be exposed through the opening 70 (Fig. 25) . Starting on the anterior aspect of the "uterus", affix the collagen sheet to the "uterus" as follows: along the central opening, glue the collared margin of the collagen sheet 70 to the "uterus" all along its entire length anterior to posterior. This should extend from just above the "vagina" where it attaches to the

"uterus" anteriorly, alongside the "uterine artery"

bilaterally, just covering the "insertions of the round ligaments" and the "ovarian suspensory ligaments" over to the posterior aspects of the "uterus" again alongside the "uterine artery" down to just above the "uterosacral" attachments. Additional tacking suture can be placed at attachment points A-H Figure 25 as well as to the

insertion points of the "uterosacral ligaments" on the posterior aspect of the "uterus" points I and J. Finally, with glue, affix the collagen sheet along all "ligament" surfaces: "round ligaments", "ovarian suspensory" and

"uterosacral ligaments. This constitutes the "anterior culdesac peritoneum" alternatively the "anterior leaflet of the broad ligament" 68A , as well as the "posterior

culdesac peritoneum" alternatively the "posterior leaflet of the broad ligament" 68P and the "pelvic side wall peritoneum".

h) Make effort to close any "peritoneum" defects. Glue the edges of 70 in order to make seamless transition from

"uterine" surface to "peritoneal" surface. This then completes the "peritoneal surface covering" of the "pelvic organs" .

i) As seen in Fig 26, on the posterior aspect of the

"uterus", the Porcine ovaries 76 are sutured at points marked A-D. Apply cyanoacrylate glue along segments A-C and B-D to fully attach adnexa in Fig 26. Separate segments of prepared chicken intestine may be attached to point B and to point A to constitute "fallopian tubes".

Basic Hysteroscopy "Uterus and Cervix" Model

Materials : Small porcine/ovine heart

Two porcine bladders (1 bladder with ureters and urethra attached and 1 bladder with urethra attached but without ureters attached) Porcine vagina

Porcine uterus (bicornuate)

Porcine gastric muscle

Additional materials: cyanoacrylate, transglutaminase powder, 2-0 or 3-0 plain gut suture, sandpaper.

Tissue Preparation:

May irrigate tissue in Bromide solution (as in prep #1) . Completely rinse with water just prior to assembly and pat-dry as possible the surfaces of the heart tissue. Heart 26 prep: As seen in Figs 28 and 29, trim heart great vessels 78 to septum 80 and excise ventricular septum to create single cavity heart. Excise valve leaflets and papillary muscles (set aside papillary muscles for use as endometrial polyps) . Excise cone shaped portion of the apex 34 of the heart at the lowest portion in order to expose small opening into the heart cavity. Roughen/scour with sandpaper both external and internal surface of heart.

Alternatively perform thin-layer excision of the entire serosal surface of the heart to expose raw pericardium. Again, dry the heart surfaces as much as possible. This will become form and substance of the "uterine corpus".

Bladder with ureters attached 84 (Bladder prep #1) : Doubly and tightly suture ligate the urethra at the cystourethral base 86 and trim urethra excess. Clear fat and loose tissue 88 from ureters. Cut small opening 90 in the dome of the bladder at the midline.

Invert the bladder, identify the ureteral orifices, excise the small ureteral valve leaflets covering the ureteral orifices and dilate the ureteral orifices. Reinvert the bladder. Lightly scour/roughen with sandpaper the external surface of the bladder. This bladder prep will be placed inside the heart with the bladder' s external surface adhered to the inner surface of the heart chamber. The dilated ureteral orifices will be the "tubal ostia" and the inner surface of this bladder will be the "endometrial" surface of the "uterus" .

Bladder without ureters (Bladder prep #2 - see Figure 7 and 8) :

dilate urethra opening 14 in order to allow placement of heart inside this bladder (see Basic "Uterus and Cervix" model) . Invert this bladder and scour/roughen its exposed anatomic internal surface of the bladder and reinvert to its normal configuration. This will become the outside surface of the "uterus". Gastric muscularis prep: As shown in Figs 32 and 33, strip gastric mucosa layer from muscularis 92 - contracted muscularis best for creating vaginal canal. Cut 6x12cm portion of muscularis that if possible includes ruggaeted folds 94. Roll and suture the long edges of the muscularis into a cylinder 96 of approximately 12 cm circumference and 6 cm length such that the ruggaeted folds are on the inner surface. Apply cyanoacrylate to the external closure line as well. This will become the "vagina". Vaginal muscle prep: Referring to Fig 34, cut a 3-4 cm length 98 of the cylindrical vagina - the part that is thickest ie closest to the bicornuate uterus is the best portion. This will become the

"cervix" . Uterus prep: Cut two 6-8 cm lengths 100 from the distal smaller ends of the left and the right pig uterus. These will become the

"adnexa" with "ovaries" and "fallopian tubes". For hysteroscopy model, no "adnexa" are necessary.

Model Assembly:

a) Coat the inner surface of the heart 26 with Transglutaminase or with cyanoacrylate as alternate method of adhesion. As shown in Fig 35, insert clamp through the opening at the apex of the heart, grasp the dome of the bladder 84 (bladder prep #1 and draw the end of the bladder through the apex opening

sufficiently to allow the ureters to remain up near the outlet of the heart and to stretch the dome of the bladder

sufficiently to provide for excess length.

b) With a clamp, penetrate through each side of the heart muscle below the edge of the opening at the heart outlet, as seen in Fig 36. Through one penetration opening, with a clamp, grasp the end of one ureter and draw it back through the heart muscle wall. Repeat for the other side.

c) As illustrated in Fig 37, oversew the outlet opening of the

heart with care not to penetrate the bladder inside; suturing should be done in order to create a "heart shaped"

configuration of the cavity of the "uterus" (more tissue included in the suturing at the center than at the sides of the heart) .

d) As shown in Fig 38, place the heart (with ureters now extruding from the lateral openings) into the bladder prep #2 92 (bladder prep #2), orienting the apex 34 of the heart towards the urethra/bladder neck. As shown in Figs 39 and 40, through each side of the dome of the external bladder (bladder prep #2) make a small opening 102 through which the ureters are then drawn with a clamp.

e) Apply cyanoacrylate circumferentially to this opening to secure the ureters to the external bladder.

f) Grasp the excess length of the dome of the inner bladder coming through the apex opening of the heart and grasp the urethral length of the outer bladder, pulling both through a 3-4 cm length of vagina (see Basic Uterus Laparoscopy model for alternatives to vagina tissue) and evert both excess bladder /urethra tissue up around the outside of the cylinder of vagina .

g) Suture the two everted layers of bladder into the heart muscle making sure to include the top rim of vaginal cylinder in the suture. Suture the full circumference of this junction.

h) May apply cyanoacrylate over this junction as well.

i) As shown in Fig 41, 42 and 43 slide the gastric muscularis

cylinder 96 over the everted ends of the bladder/urethra and circumferentially suture the cylinder into the heart muscle immediately superior to the line of attachment of the "cervix" to the "uterus". This then completes the "uterus" with "cervix" with the inner part of the "fallopian tubes" coming out the sides of the "uterus" and "vagina" as seen in Fig 42.

As illustrated in Figs 44 and 45, slide a 6-8 cm length of distal uterus 100 over the extruded ureter and apply

cyanoacrylate to attach this to the base of the ureter as it exits the bladder/heart. Distally ligate both the uterus and ureter in order to close off the ureteral opening. Trim the excess. Repeat this for the opposite side ureter. This then completes the "fallopian tubes" with ligation effected at their end in order to prevent efflux of hysteroscopy fluid during the simulation procedure.

Various other alternatives and embodiments that are within the scope of the invention include: thologic "Uterine" prep alternatives for laparoscopy and hysteroscopy a) Chicken or Turkey Gizzard whole/uncut -makes for "fibroids" implantable in uterus with surface attachment achieved by transglutaminase or cyanoacrylate. b) Larger "fibroids" are constructed of bromide blanched (1:10 dilution of bromide as >2 hr soak) semi-dessicated heart muscle masses cut to size and glued into concave defects scooped out of the heart muscle prep prior to the overlay of the bladder. Alternatively, multiple whole and part segments of

chicken/turkey gizzard cut and liberally dusted with

transglutaminase and "formed" into solid/rounded mass. c) Porcine/ovine Colon segment - makes for "sigmoid/rectum" segment . d) Porcine small intestine segment - makes for "small intestine" with cyanoacrylate for adhesive attachment. e) Ovine/porcine uterine didelphys placed within a heart

modified by excising the lower ventricular septum and coring out both tricuspid and mitral valves, with distal ends of uterine horns pulled through the upper corners of heart, the whole then covered with bladder prep #2 creates uterine septum model . f) Ovine/Porcine heart papillary muscles fixed to the inner surface of the basic hysteroscopy model by anchor suturing through the basic hysteroscopy model wall makes for endometrial polyps . g) Proliferative endometrium - Sheets of porcine/ovine gastric mucosa attached with transglutaminase within bladder prep as part of hysteroscopy model. h) Missed abortion - spleen puree mixed with transglutaminase injected into hysteroscopy prep. thologic "Ovarian" preps i) "Ovarian Cysts": Selected contents (see below for different simulation) placed within a ligated ligated segment of dilated chicken small intestine. This cyst prep then placed within mechanically dilated end of porcine/ovine uterus and ovary affixed with cyanoacrylate. "Dermoid" - almagm of ovine wool and porcine hair mixed with pureed fat emulsion.

"Mucinous cyst" - gastric mucosal fluid lightly scraped off gastric endothelium mixed with pureed fat emulsion.

"Serous cyst" - pureed fat emulsion

"Multicystic ovary" - chicken lung intact explants cannulated and under pressure filled with water. Alternatively, multiple porcine/ovine ovaries adhered together. ii) "Ovarian Solid Masses": Immature Porcine/ovine/bovine testes adhered to "ovarian suspensory ligament".

Pathologic Tubal preps

i) Ovine/Porcine distal uterine horn segments (alternatively cleaned chicken small intestine) within which is drawn proximal ureter segments (with interfaced transglutaminase) affixed along surrounding cylindrical wrap of half-cut length of esophagus muscularis makes for tubal segment appropriate for reanastomosis and pathologic alteration eg ectopic. ii) "Ectopic Pregnancy" - 2 cc amount of lung and spleen puree placed within a doubly ligated dilated segment of proximal ureter then placed within a segment of ovine/porcine distal uterine horn. This prep then affixed along the half-cut

esophagus muscularis segment.

Surgical Models

Laparoscopy - Laparoscopic Total Hysterectomy Prep - uterus (normal sized <200 gm) without fibroids, vagina, fallopian tubes and ovaries, uterine arteries, uterosacral ligaments, round ligaments, peritoneum

(bilateral broad ligaments) .

- Enlarged Hysterectomy Prep - Enlarged uterus (200-450gm) without fibroids, vagina, fallopian tubes and ovaries, uterine arteries, uterosacral ligaments, round ligaments, peritoneum (bilateral broad ligaments) .

- Laparoscopic Multiple Myomectomy Simple Prep - Enlarged uterus with multiple fibroids, vagina, round ligaments, uterosacral

ligaments, peritoneum.

- Laparoscopic Multiple Myomectomy Complex Prep - Enlarged uterus with multiple fibroids including broad ligament fibroid with

proximity to uterine artery, uterosacral ligaments, round ligaments, peritoneum (bilateral broad ligaments) .

- Laparoscopic Excision of ovarian Cyst Prep - Dermoid, mucinous, serous tumors .

-Laparoscopic Excision of ectopic pregnancy - salpingostomy,

salpingectomy

- Laparoscopic benign BSO Prep - bilateral normal ovaries

- Laparoscopic Hysterectomy Complication Prep - Cystotomy,

Rectosigmoid repair, ureterostomy/reanastomosis - Laparoscopic Total Hysterectomy Prep with bladder and ureters along normal anatomic course, sigmoid colon and exiting rectum.

- Laparoscopic Tubal Reanastomosis Prep - bilateral tubal occlusions

- Laparoscopic Pathologic Oopherectomy Prep - Enlarged 6-8cm solid ovarian mass, multicystic ovary

- Laparoscopic prostatectomy Hysteroscopy

- Hysteroscopic Myomectomy Prep - Uterus with multiple small 1-4 cm submucosal (type 1) or intramural (type 2) fibroids. - Hysteroscopic Tubal Occlusion Procedures - Patent bilateral tuba ostia .

- Hysteroscopic polypectomy Prep - Uterus with multiple polyps.

- Hysteroscopic endometrial resection Prep - Uterus with endometri

Claims

Ex vivo organ model comprising::

i) a bladder (10) of mammalian, non-human origin with

attached urethra arranged to form an artificial human uterine and cervical serosal surface; ii) a heart muscle (26) of mammalian, non-human origin,

wherein the heart muscle has been sculptured to form an artificial human uterine muscle and placed into the bladder (10), the opening of the bladder being oriented to the apex of the heart (34) and wherein the outlet of the heart is oriented to the dome of the bladder; iii) a piece of an upper vagina of mammalian, non-human

origin or a piece of esophagus muscularis of mammalian, non-human origin where the endothelium have been removed, wherein the vagina or esophagus muscularis (38) encircle the urethra/bladder neck (14) and wherein the urethra/bladder neck (14) is reversed above the vagina or esophagus muscularis to form an artificial human cervix .

Ex vivo organ model according to claim 1, wherein the bladder and or the heart muscle is of porcine, ovine or bovine origin.

Ex vivo organ model according to claim 1, wherein the upper vagina of iii) is of porcine origin, and wherein the esophagus muscularis is of porcine, ovine or bovine origin.

Ex vivo organ model according to one of the preceding claims, further comprising a piece of gastric muscularis of mammalian, non-human origin cut and arranged as a cylinder, said cylinder being arranged about the artificial cervix to form an

artificial human vagina.

Ex vivo organ model according to one of the preceding claims, further comprising a first piece of esophagus muscularis of mammalian, non-human origin, folded and attached to the bladder to form artificial human uterosacral ligaments.

Ex vivo organ model according to claim 5, further comprising a second piece of esophagus muscularis of mammalian, non-human origin, arranged passing through the bladder to form an

artificial human round ligaments.

Ex vivo organ model according to claim 6, further comprising a third piece of esophagus muscularis of mammalian, non-human origin, arranged passing through the bladder to form an

artificial human ovarian suspensory ligament.

Ex vivo organ model according to one of the preceding claims, further comprising a sheet of collagen of mammalian origin attached to the artificial ligament surfaces and arranged to form an artificial human peritoneum.

Ex vivo organ model according to one of the preceding claims, further comprising mammalian, non-human ovaries attached to form artificial human ovaries.

Ex vivo organ model according to one of the preceding claims, wherein the mammalian bladder has attached ureters, and is arranged inside a second mammalian bladder having the ureters removed, and wherein the ureters from the first bladder extend through holes in the heart muscle and the second bladder to form artificial human fallopian tubes.

11. Ex vivo model according to claim 1, wherein the bladder and or the heart muscle is of porcine, ovine or bovine origin, the upper vagina is of porcine origin, and wherein the

esophagus muscularis is of porcine, ovine or bovine origin, the gastric muscularis and the esophagus muscularis is of porcine or ovine origin.

12. Ex vivo organ model according to one of the preceding

claims wherein the mammalian, non-human tissues are by-products of the meat packing industry.

13. A method for preparing an ex vivo organ model, comprising the step of arranging mammalian, non-human organs to mimic a human uterus and cervix.

The method according to claim 13, wherein additional mammalian, non-human organs are further arranged to mimic human vagina.

15. The method according to claim 14, wherein the mammalian, non-human organs are further arranged to mimic human fallopian tubes and peritoneum.

The method according to one of claims 13-15, wherein the uterus comprises a mammalian, non-human heart arranged inside first mammalian, non-human bladder, and the cervix comprises a segment of mammalian, non-human upper vagina or esophagus muscularis arranged about an extended portion of the opening o the bladder.

17. The method according to one of claims 13-16, further

comprising the steps of arranging the heart inside the bladder such that the apex of the heart is oriented with the opening of the bladder, extending the opening of the bladder past the heart, arranging a cylindrical piece of mammalian, non-human tissue about the extended opening portion of bladder, and inverting the extended opening portion of the bladder back over the cylindrical piece of tissue.

The method according to claim 17, further comprising the steps of attaching elongated segments of mammalian, non-human tissue to the bladder to mimic human uterosacral and/or round ligaments .

19. The method according to claim 17, further comprising the step of attaching sheets of mammalian, non-human collagen to mimic a human peritoneum.

20. The method according to claim 17, wherein the first ladder has attached ureters, and wherein the heart and first bladder are arranged inside a second bladder, and further comprising the steps of pulling the ureters through the heart and second bladder to mimic human fallopian tubes.