Tracheal collapse: clinical trial in dogs (CasMin Twine)


3.775 out of 18.330 euros

3.775 euros raised
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It is a chronic and progressive disease of the trachea and lower respiratory tract, without effective treatment

The project
Who is behind

What is our goal?

Tracheal stenosis (tracheal collapse) is a pathology whose medical alternative consists on the placement of intra-tracheal prostheses that keep its lumen open. These prostheses can be metallic or plastic.

One of the causes of tracheal stenosis is tracheomalacia. It is characterized by a soft tracheal cartilage, which prevents it from being a "rigid tube" and as result it becomes a flaccid structure unable to remain open during the respiratory cycle.

In the case of humans, it is a congenital abnormality that mainly affects children. While patient´s grow, the cartilage acquires its normal consistency, but in the meantime, it is necessary to keep an open growing trachea. For this reason, it is necessary to place plastic prostheses of different sizes that adapt it to the rapid growth of the patient. To achieve this objective, the use of plastic prostheses is necessary. However, they present numerous complications, such as: migration, mucous accumulation, infection, and/or reduction of the tracheal lumen.

In the case of animals, dogs are the most affected, but unlike in humans, it is a frequent disease observed in older animals and it is a degenerative process that worsens over time. The alternative treatment involves aggressive open surgery, in which extratracheal rings are placed. It provides support from outside the trachea. Alternatively, the implantation of a metallic stent inside it.

In these cases, the implantation of these prostheses is a quick procedure with fewer possibilities of short-term complications compared to open surgery. However, in the medium and long term, complications such as migration, stent fracture, accumulation of mucus, infection or intraluminal tissue overgrowth may occur due to the reaction of a foreign body. All these complications are difficult to solve since these stents are not removable. Once implanted, they remain embedded in the tracheal wall and cannot be removed.

CasMin Twine is a new prosthesis that, given its helical design, allows a new way of placement. The prosthesis is fixed to the trachea, completely avoiding migration and, it is removable with a lower risk of breakage and, consequently, the appearance of intraluminal overgrowth. Its simple morphology adapts to the anatomy of the trachea, moving with it in respiratory cycles and reducing the amount of metal in contact with the tissue.

In the first stage, prototypes were made in steel and satisfactory results were obtained after 12 months. Efficacy, tissue compatibility, ease of handling, and reproducibility were tested. After this, a clinical study was started in pathological canine patients. The prototypes of the prosthesis are made of nitinol, a biocompatible, superelastic and shape memory material, which provides it with suitable characteristics for its application.

The clinical study began about a year ago and, so far, 7 canine patients have been recruited, with a maximum follow-up of 11 months.

The current results are being promising, so it is considered that expanding the study to increase the number of patients and their follow-up would allow more reliable results.

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C/Pintor Murillo, 15
28100 Alcobendas (Madrid) - España
T.+(00 34) 91 425 09 09
A project from :Logo Ministerio
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