Synthetic vaginal cuff model and method of simulating vaginal cuff closure

Abstract

A vaginal cuff surgical model and methods of manufacture and use thereof. The model includes a body (resembling a vaginal cuff) and appendages (resembling uterosacral ligaments) extending from the body. The model (body and appendages) is formed of silicone, rubber, a polymer, or other suitable material with one or more layers of mesh embedded within the polymeric material. The embedded mesh permits suture between the components of the model. The surgical model permits surgical practice of this important component of a total hysterectomy procedure via suturing across the model and to the appendages.

Claims

1. A vaginal cuff surgical model, comprising: a rounded body resembling a vaginal cuff of an animal, said rounded body having a hollow interior and at least one open end, said rounded body formed of a polymeric material with a first embedded layer of mesh disposed along said rounded body in a first position suitable for suture; and an appendage that resembles a uterosacral ligament extending from said rounded body at a lateral angle of said rounded body, said appendage formed of a polymeric material with a second embedded layer of mesh disposed along said appendage in a second position suitable for suture, wherein said first and second embedded layers of mesh are structured to receive suture therebetween in order to affix said appendage to said rounded body.

2. A vaginal cuff surgical model as in claim 1, further comprising: said polymeric material selected from the group consisting of silicone, rubber, foam, and a combination thereof.

3. A vaginal cuff surgical model as in claim 1, further comprising: said first and second embedded layers of mesh are formed of nylon tulle netting mesh.

4. A vaginal cuff surgical model as in claim 1, further comprising: said first layer of embedded mesh being embedded 1-2 mm below an outer surface of said rounded body.

5. A vaginal cuff surgical model as in claim 1, further comprising: said second layer of embedded mesh being embedded 1-2 mm below an outer surface of said appendage.

6. A vaginal cuff surgical model as in claim 1, further comprising: a resin or liquid silicone binder.

7. A method of manufacturing a vaginal cuff surgical model, comprising: providing a first polymeric material in a mold of a rounded body that mimics a vaginal cuff of an animal; embedding a first layer of mesh in said first polymeric material; providing a second polymeric material in a mold of an appendage that mimics a uterosacral ligament of said animal; embedding a second layer of mesh in said polymeric material, wherein said first and second embedded layers of mesh are structured to receive suture therebetween in order to affix said first and second polymeric materials together.

8. A method of manufacturing a vaginal cuff surgical model as in claim 7, further comprising: the step of embedding said first layer of mesh including embedding said first layer of mesh 1-2 mm below an outer surface of said first polymeric material.

9. A method of manufacturing a vaginal cuff surgical model as in claim 7, further comprising: the step of embedding said second layer of mesh including embedding said second layer of mesh 1-2 mm below an outer surface of said second polymeric material.

10. A method of manufacturing a vaginal cuff surgical model as in claim 7, further comprising: applying a resin or liquid silicone binder to said first polymeric material and said first layer of mesh.

11. A method of manufacturing a vaginal cuff surgical model as in claim 7, further comprising: applying a resin or liquid silicone binder to said second polymeric material and said second layer of mesh.

12. A method of manufacturing a vaginal cuff surgical model as in claim 7, further comprising: detachably coupling said first polymeric material embedded with said first layer of mesh to said second polymeric material embedded with said second layer of mesh.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) For a fuller understanding of the invention, reference should be made to the following detailed description, taken in connection with the accompanying drawings, in which:

(2) FIG. 1 depicts an embodiment of the current invention.

(3) FIG. 2A depicts an alternate embodiment of the current invention as part of a vaginal cuff suture pad.

(4) FIG. 2B is a closer-up view of the embodiment of FIG. 2A.

(5) FIG. 3A is an image showing a cut made into a mesh-silicone model, showing the embedded mesh about 2 mm below the surface of the silicone.

(6) FIG. 3B is an image showing initial suturing of the model of FIG. 3A,

(7) FIG. 3C is an image showing further suturing of the model of FIG. 3B.

(8) FIG. 4A depicts a vaginal cuff suture pad disposed on a simulation stand for simulating vaginal cuff closure, according to an embodiment of the current invention.

(9) FIG. 4B is an end view of the vaginal cuff suture pad and simulation stand of FIG. 4A.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

(10) In the following detailed description of the preferred embodiments, reference is made to the accompanying drawings, which form a part thereof, and within which are shown by way of illustration specific embodiments by which the invention may be practiced. It is to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the invention.

(11) As used in this specification and the appended claims, the singular forms a, an, and the include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term or is generally employed in its sense including and/or unless the context clearly dictates otherwise.

(12) As used herein, about means approximately or nearly and in the context of a numerical value or range set forth means 15% of the numerical.

(13) As used herein animal means a multicellular, eukaryotic organism classified in the kingdom Animalia or Metazoa. The term includes, but is not limited to, mammals. Non-limiting examples include rodents, aquatic mammals, domestic animals such as dogs and cats, farm animals such as sheep, pigs, cows and horses, and humans. Wherein the terms animal or mammal or their plurals are used, it is contemplated that it also applies to any animals.

(14) As used herein the term patient is understood to include an animal, especially a mammal, and more especially a human that is receiving or intended to receive treatment.

(15) In an embodiment, the current invention is a vaginal cuff surgical model with uterosacral ligaments. The surgical model is formed of silicon, rubber, foam, or other suitable material with mesh embedded and/or layered therein. The model, as seen in FIGS. 1-2, mimics a vaginal cuff having integrated ligaments for adhesion to the base of the model. The integrated mesh in the model allows suturing of the features without ripping out of the sutured area, similar to that seen in FIGS. 3A-3C.

(16) Examples of materials that can be used to form the surgical model include, but are not limited to, Polyacrylate Rubber, Ethylene-acrylate Rubber, Polyester Urethane, Bromo Isobutylene Isoprene, Polybutadiene, Chloro Isobutylene Isoprene, Chlorosulphonated Polyethylene, Polychloroprene, Epichlorohydrin, Ethylene Propylene, Ethylene Propylene Diene Monomer, Polyether Urethane, Perfluorocarbon Rubber, Fluoro Silicone, Fluorocarbon Rubber, Hydrogenated Nitrile Butadiene, Polyisoprene, Acrylonitrile Butadiene, Polyurethane, Styrene Butadiene, Styrene Ethylene Butylene Styrene Copolymer, Polysiloxane, Vinyl Methyl Silicone, Acrylonitrile Butadiene Carboxy Monomer, Styrene Butadiene Carboxy Monomer, Thermoplastic Polyetherester, Styrene Butadiene Block Copolymer, Styrene Butadiene Carboxy Block Copolymer. In some instances, the material is layered to simulate fascia. Inclusion of specific mesh material can further simulate the fascia. In specific embodiments, the model can be printed using a 3-dimensional printer.

(17) The embedded mesh can be formed of plastic or other polymer or suitable material.

(18) Surgical Procedure

(19) A common problem encountered during both vaginal and abdominal hysterectomies is vaginal prolapse post-hysterectomy. During a hysterectomy, the uterosacral-cardinal ligament complex must be detached from the uterus. Subsequently, the uterosacral-cardinal ligament complex can be reattached to the vaginal cuff to reduce risk of vaginal prolapse. This reattachment is important to provide support to the vaginal cuff so that prolapse does not occur. This reattachment procedure can occur prior to removal of the uterus or after removal of the uterus, depending on the surgeon and planned procedure. If the hysterectomy is taking place because of prolapse, the uterosacral ligaments may need to be shortened to reduce, eliminate, or otherwise repair any laxity prior to reattachment to the vaginal cuff. A similar procedure can be performed with the cardinal ligament. Each of these methodologies are known in the art for supporting the vaginal cuff post-hysterectomy.

EXAMPLE

Method of Fabrication

(20) Nylon tulle netting mesh was placed into a mold resembling a vaginal cuff with uterosacral ligaments, and silicone rubber was poured to create a multi-layered model. The resulting model has the representation of fascia due to the mesh layer(s) located 1-2 mm below the surface of the silicone. The model combines several layers that mimic closely what one would find in real skin at that vaginal cuff anatomy. The layers are reinforced to tolerate tension and pulling while suturing and practicing other procedures.

(21) Silicone rubber or foam or a combination of the two are layered with mesh in order to simulate the vaginal cuff with uterosacral ligaments. A resin, or liquid silicone, can be added and allowed to bond the layers.

EXAMPLE

Surgical Model

(22) As can be seen in FIGS. 1-2, the surgical model mimics the appearance of a vaginal cuff with uterosacral ligaments extending from the lateral angles of the vaginal cuff. In the model, the uterosacral ligaments are prefabricated and molded into the silicone, in which case the surgeon can opt to cut them if necessary. It is also envisioned that the uterosacral ligaments can be detachable from the body of the vaginal cuff. The uterosacral ligaments can then be sutured to the body of the vaginal cuff using the embedded mesh, as indicated in FIGS. 3A-3C. Optionally, cardinal ligaments (not shown) can be included in the surgical model according to the current invention.

(23) In this surgical model, the suture has the ability to remain in the model and not rip, thus providing a significant benefit to the surgical team. The tension on the ligaments are similar to that of real patients. Suturing the cuff closed is similar to what would occur in an actual surgery once the uterus was removed.

(24) In an embodiment, the surgical model can include an aluminum base (see FIG. 1) that holds the vaginal cuff in its position and has suction cups on its lower surface to secure itself to a base (e.g., countertop).

(25) The surgical model provides a practical, tangible solution to a surgical team's ability to practice this aspect of a total hysterectomy, thus increasing chances of success during actual surgery and minimizing risk of vaginal prolapse post-hysterectomy.

EXAMPLE

Cuff Closure Simulation

(26) FIGS. 4A-4B depict the vaginal cuff suture pad of FIGS. 2A-2B as disposed on a hinged, simulation stand that has multiple stable, angled positions to maintain the suture pad at an angle relative the x axis. To simulate closure of a vaginal cuff, a six-cuff model is positioned on the suture pad stand. The stand is angled to the desired/preferred level; optionally, there can be three (3) distinct angled positions (as can be seen in the figures) or it can be stable at any angle. Different angles can provide for different types of training and additional challenges for the surgeon.

(27) Optionally, the stand can be placed within a laparoscopic (e.g., SIMSEI Laparoscopic Trainer) to simulate the abdominal cavity. Alternatively, the stand can be placed upon a table or other flat surface for simulating the procedure. Once in the desired location, the suction cups (not shown in these figures but indicated in FIG. 1), can be pressed down to hold the stand and suture pad in place.

(28) Subsequently, the surgeon can begin simulation of the cuff closure procedure of the vaginal cuff model. Utilizing laparoscopic instruments, the surgeon can suture one side of the cuff and continue suturing across the cuff. In the event that the training involves suturing to the uterosacral ligaments, each cuff model includes an extension on each side of the cuff to represent a uterosacral ligament.

(29) This cuff closure simulation can be performed six (6) times to train effectively for the procedure with the goal being to develop a seamless integration of the cuff. Upon completion of the simulation/training, the sutures can be cut and removed, thus permitting use of the suture pad, which can then be removed from the stand, and the stand can be re-used with another suture pad including additional cuff models.

(30) The advantages set forth above, and those made apparent from the foregoing description, are efficiently attained. Since certain changes may be made in the above construction without departing from the scope of the invention, it is intended that all matters contained in the foregoing description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

(31) It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention that, as a matter of language, might be said to fall therebetween.