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Innovation & Technologie Angebot

New prosthesis for vaginal agenesis and sex change interventions

Country of Origin: Spain
Reference Number: TOES20180327002
Publication Date: 27 March 2018

Summary

A Spanish research biomedical foundation in collaboration with a university engineering research group has developed a new prosthesis to create an artificial vaginal cavity or neovagina following the surgical McIndoe technique. Its design allows a less aggressive surgery, does not require skin graft. The research team is looking for companies interested in license agreement for its exploitation. It is also open to technical collaboration for the adaption to the market needs.

Description

A biomedical research team from a health foundation, in collaboration with a bioengineers from a Spanish university, has developed a health prosthesis intended to be placed temporarily in women with vaginal agenesis and in sex change interventions, to create an artificial vaginal cavity or neovagina  following the surgical McIndoe technique.



Historically, the creation of a neovagina with a prosthesis and skin graft (McIndoe technique) has been the most common surgical procedure. The difference between the surgical techniques, used to date, lies in the material used to line the newly created channel: Skin grafts, peritoneum, buccal or vesical mucosa, autologous in vitro cultured tissue from vaginal vestibule, amnion and others. The major inconvenient of this technique are:

- Making skin graft and the permanent scar in the donor area

-The prosthesis used as mold, its material weight and stiffness can produce bedsores or necrosis.



The prosthesis, developed using 3D printing technology (additive construction), allows a precise geometry and the adaptation to the surgery's needs or the development of personalized prosthesis. The material used brings light weighting, stiffness and stimulates healing and skin formation in the neovagina. 

The prosthesis body, and the support plate, are made of Polylactic Acid (PLA), chosen for its biocompatibility and for its ability to stimulate epithelial regeneration. For the external coating of the prosthesis, silicone is used, a material that is also biocompatible, soft and non-stick once solidified. The design allows an almost outpatient surgery, more easy, without further dermal scarring and providing women more comfort and functionality.



In this way, the surgical intervention to perform neovagina or artificial vagina, as it does not require skin grafting, will be shorter and less aggressive, facilitating the technique for professionals and a shorter hospital stay for the patient.



Several prototypes have been developed and are at the moment used in a clinical trial.



The research team is looking for medical supplies companies providing solutions in the fields of Gynecology and Obstetrics willing to sign a license agreement and developing the necessary know-how for its later commersialisation. 



Due the early stage of this technology (TRL 3 – 4), the research group is open to work, together with the interested company, in a technical cooperation agreement, to develop the necessary requirements and know-how (regulatory health affair, proof of concept in candidates, initial clinical validation, etc.) to put these medical devices into the market.

Advantages and Innovations

•	The new system is better suited to the anatomy of the vagina because it has been developed with 3D technology, protects more the anatomy soft parts and is much lighter.

•	The 3dD additive construction technique allows a precise geometry and the adaptation to the surgery's needs.

•	This product replaces craft prostheses (described in the scientific literature).

•	It avoids complications related to the craft prostheses as decubitus or urethra ulcers.

•	It is better suited to the anatomy of the vagina, protecting more the soft part.

•	It is much lighter but ensuring the correct stiffness.

•	Its application allows to form the vagina using less aggressive surgery techniques than in the present. The surgical intervention will be shorter and less aggressive, facilitating the technique for professionals and a shorter hospital stay for the patient.

•	The design is intended to be also used as a mold, or dilator, by the patient herself after surgery.

•	The material stimulates healing and skin formation in the neovagina.

•	It not requires skin graft, improving the patient’s comfort.

•	Avoid complications related to the surgery. 

•	The patient can go home the next day with this new technique.

•	The patient achieves a faster recovery and improved self-esteem with less risk.

Stage Of Development

Under development/lab tested

Stage Of Development Comment

Prototype available for demonstration

Requested partner

-Type of partner sought: health companies, manufacturers of medical prosthesis and devices in the field of Gynecology and/or Obstetric.



-Specific area of activity of the partner: mold making in health plastic sector, health, gynecology, plastic and aesthetic surgery. 



-Task to be performed: licensing for commercialization. Technical cooperation for further developments or adaptation of this developed technology to the specific requirement of the medical supplies market could be considered. Medical device accreditation in EU health-market regulatory authority.