Codubix® prosthesis for cranioplasty

Characteristics

Codubix®️ skull bone prostheses are made of knitting technique from:

  • polyester yarn – providing adequate strength, both bending and compression, and surface unfolding,
  • polypropylene yarn – characterised by a low specific weight and a low melting point, which makes it possible to give the prosthesis adequate stiffness and hardness.

High strength, low specific gravity, hydrophobicity contributing to the lack of absorption of liquids and physiological fluids, non-toxicity, lack of chemical activity, good degree of healing make the Codubix®️ skull prostheses identifiable with the natural skull bone in terms of their physical properties. Codubix®️ prostheses are easy to model during implantation and enable diagnostics without producing artifacts.

Indications
Knitted Codubix®️ skull bone prostheses are intended for filling bone defects in the skull cap.

Contraindications
There was no evidence of local intolerance of the implanted material. It is not recommended to implant Codubix®️ prostheses in children and in places where the physiological growth process limits their use.

Guidelines
An important element of the cranioplasty procedure is to plan the cut of the skin so that it runs at a minimum distance of 1 cm from the edge of the bone defect. After the skin flap has been detached, the periosteum is cut along the edge of the bone defect and moved to the outside as much as it is necessary to prepare the bone defect. The periphery of the bone defect and the Codubix®️ prosthesis are prepared according to the drawings provided. The outer edge marked in Fig. 1 is greater than the inner edge. The prosthesis fills the bone defect like a wedge (Fig. 2). In order to fix the Codubix®️ prosthesis, holes should be made both in the prosthesis and in the natural bone at a distance of 5 mm from the edge of the prosthesis and the edge of the bone. These holes are made with a dental drill or a punch with a drill diameter of 2 mm.


Immediately before fixing the prosthesis, it is necessary to perform hemostasis. After the fastening threads have been passed through the holes, it is advantageous to press the resulting knot into the hole in the prosthesis. Proper adjustment of the prosthesis as well as good contact between the prosthesis edge and the bone edge as well as strong tightening (during the binding of the fixing sutures) guarantee the non-displacement of the prosthesis against the bone. The preserved periosteum is attached to the prosthesis with an atraumatic suture, thus covering the joint between the prosthesis and the skull bone. In cases of extensive cranioplasty, it is advisable to install suction drainage in the space under the skin flap for 1 day after the surgery.

Application*
Before using the Codubix®️ prosthesis, carefully assess:

  • the size of the defect
  • shape of the cavity curvature in accordance with the individual structure of the skull

The final selection and adjustment of the prosthesis to the defect takes place during the surgical procedure (the prosthesis can be cut). After modeling, the prosthesis should be thoroughly cleaned of the dust formed during the fitting, by rinsing it in a saline solution.

* Prepared by Prof. J. Brzeziński, Ph.D., J. Gawlik, Ph.D. Department of Neurosurgery, Institute of Diseases of the Nervous System and Sensory Organs, Medical University of Lodz.

The cleaning procedure (time, amount of saline solution) may vary depending on the shape and size of the individual trimmed prosthesis. It is necessary to ensure thorough cleaning of all visible impurities.

Precautions

  1. Codubix®️ skull defect prostheses are offered for sale non sterile.
  2. Sterilisation should be performed in an autoclave, using a validated method, according to the parameters given in point sterilisation.
  3. Maximum double sterilisation is allowed in the case of a non-implanted device.
  4. Codubix®️ prosthesis should not be implanted after the expiry date.
  5. The product is for single use only. Due to the method of implantation, the device cannot be reused.
  6. The process of forming, cleaning and repacking the prosthesis should be carried out under aseptic conditions.
  7. The product should not be steam sterilised in the packaging provided by the manufacturer.

Sterilisation conditions
Codubix®️ skull prostheses are delivered non sterile. The sterilisation process should be carried out by a validated steam sterilisation method in an autoclave:

  • at 121oC
  • for 20 min.

It is recommended that the packaging protects the product against physical damage and meets the requirements for medical packaging intended for steam sterilisation.
The personnel involved in the sterilisation process should have the necessary qualifications to conduct the steam sterilisation process (according to the requirements of EN ISO 17665-1).

Possible complications
The implantation of all skull bone prostheses can cause many types of complications, i.e .:

  1. in the early postoperative period: infection, hematoma, swelling of the skin flap, appearance of blood and serous fluid exudates, increased body temperature, ischemia of the cutaneous flap,
  2. in the long postoperative period: pain in the scar, sensory disturbances, collapse of the prosthesis.

All the above-mentioned complications may contribute to the extension of the treatment time, re-intervention of the surgeon and, in extreme cases, the re-implantation of the prosthesis.

Storage conditions
Codubix®️ prostheses should be stored in:

  • shaded rooms,
  • temperature 15oC-35oC
  • humidity range 25-65%
  • conditions protecting against wetting and mechanical damage or chemical contamination
  • the original unit packaging (cardboard box and immediate packaging). Any mechanical damage to the packaging may expose the product to loss of sterility.
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