PERSONALIZED MEDICAL DEVICE AND METHOD OF ITS PREPARATION

Abstract

A personalized medical device intended for correction of defects, in particular in the orofacial area is multicomposite and comprises a hard tissue replacement and a soft tissue replacement. The hard tissue replacement is a hard core of biocompatible thermoplastic material and the soft tissue replacement is a biocompatible elastic substance. Preparation of personalized medical device even in the prenatal period using CT, MRI and 3D/4D electronic USG imaging and “additive manufacturing” technology.

Claims

1. A personalized medical device intended for correction of defects in the orofacial area, is multicomposite and comprises a hard tissue replacement and a soft tissue replacement, wherein the hard tissue replacement is a bone tissue replacement of biocompatible thermoplastic material and the soft tissue replacement is a muscle and epithelial soft tissue replacement of biocompatible elastic substance, wherein the biocompatible thermoplastic material for the non-implantable device is polypropylene sulfone and the biocompatible thermoplastic material for the implantable device is a synthetic osseointegratable non-resorbable material which are polyaryl ketones or polyaryl ketones in combination with ceramics or polyaryl ketones in combination with ceramics and with reinforcement.

2. The personalized medical device according to claim 1, wherein the reinforcement is made of glass fibres.

3. (canceled)

4. The personalized medical device according to claim 1, wherein the shape of the personalized medical device is adapted to attach to an alveolar arch.

5. A method for preparation of the personalized medical device according to claim 1, wherein the method takes place at the prenatal time examined by CT, MRI, USG to obtain DICOM data and comprises the following steps: a) preparation of image dataset of 2D image sections of interest of damaged hard and soft tissues of fetal orophation obtained by USG visualization; b) the prepared image dataset of 2D image sections of interest of three mutually perpendicular planes is adjusted by multiplanar, rendering, sectional and volume adjustment to a 3D ultrasound dataset of anthropometric and anatomical data; c) the prepared 3D ultrasound dataset of the scanned sections is processed into the output 3D image format; d) the most suitable anatomical areas of interest are selected by post-processing processing of 3D image format; e) subsequently the modelling of the PNAM device itself is realized, which includes both hard and soft palate; f) subsequently the 3D image format is compared also with MRI and CT imaging of fetal orophation; g) a 3D/4D ultrasound, CT and MRI algorithm for displaying facial clefts with the creation of post-processing output of DICOM data for 3D modelling and processing for additive manufacturing in form of 3D printing is created. h) anthropometric and anatomical data using DICOM editable software platforms are evaluated and a digital reference model in form of a STL network model with accurate localization of the hard and soft tissues defect is created; i) the extent of hard and soft tissue deformation is measured exactly on a digital reference model; j) based on a digital reference model, a digital personalized medical device is created; k) a clinically applicable model of a personalized multicomposite medical device containing hard tissue and soft tissue replacement is produced.

6. The method for preparation of the personalized medical device according to claim 5, wherein the hard tissue replacement is surface treated by coating or dipping.

7. The method for preparation of the personalized medical device according to claim 5, wherein prior to producing a clinically applicable model of the personalized medical device, a reference model of the deformity itself as well as a medical device model is additively produced, wherein there are validated dimensions on the reference models and are considered by consultation in terms of fixation and application parameters.

8. The method for preparation of the personalized medical device according to claim 6, wherein the surface treatment of the hard tissue replacement is adapted to attach residual cleft-affected soft tissue of orophation.

Description

EXAMPLES OF EMBODIMENTS

Example 1

[0066] A personalized medical device according to this invention intended for correction of defects in the orofacial area is prepared. It is multicomposite and comprises a hard tissue replacement and a soft tissue replacement. The hard tissue replacement is a hard core of biocompatible thermoplastic material and the soft tissue replacement is a biocompatible elastic substance. The medical device is non-implantable.

[0067] A biocompatible thermoplastic material used as a hard tissue replacement in this example of embodiment is hardened silicone.

[0068] A biocompatible elastic material used as a soft tissue replacement in this example of embodiment is elastic silicone.

[0069] The surface treatment of the hard core of hardened silicone is adapted to attach even the cleft-affected soft tissue. In this example of embodiment, the surface treatment is solved by coating.

[0070] The shape of the personalized medical device is adapted to attach to an alveolar arch.

[0071] A method for preparation of the personalized medical device according to this example of embodiment comprises the following steps: [0072] preparation of image dataset of 2D image sections of interest of damaged hard and soft tissues of fetal orophation obtained by USG visualization;

TABLE-US-00001 Visualization Visualization USG image plane benefits restrictions Transverse- ventral Clear diagnosis of cleft extent and depth Feasible only if the fetus is in an adequate position Transverse- lateral An section suitable for examination for In the case of bilateral clefts, exposure to a the extent of a lip possible inadequate defect, but limited definition of the to some extent in defect, which may the description of be located even a bone defect more distal from the probe Oblique-lips Excellent plane for examination of lip defect and Feasible only if the fetus is in an adequate position possible abnormalities of alae nasi Oblique-palate Good approach for the examination of Feasible only if the fetus is in an adequate position. cleft bone defects It also does not and their give information relationship to the about the lips. nasal cavity Coronal-facial Good area for imaging central defects of the A lateral defect does not appear in this type of section nose and lip Midsagittal- profile It allows to detect and distinguish the adjacent area of the soft tissue No information about unilateral clefts except philtrum cleft of the palate, uvula and philtrum in bilateral clefts [0073] the prepared image dataset of 2D image sections of interest of three mutually perpendicular planes is adjusted by multiplanar, rendering, sectional and volume adjustment to a 3D ultrasound dataset of anthropometric and anatomical data; [0074] the prepared 3D ultrasound dataset of the scanned sections is processed into the output 3D image format; [0075] the most suitable anatomical areas of interest are selected by post-processing processing of 3D image format; [0076] subsequently the modelling of the PNAM device itself is realized, which includes both hard and soft palate. [0077] subsequently the 3D image format is compared also with MRI and CT imaging of fetal orophation; [0078] a 3D/4D ultrasound, CT and MRI algorithm for displaying facial clefts with the creation of post-processing output of DICOM data for 3D modelling and processing for additive manufacturing in form of 3D printing is created. [0079] anthropometric and anatomical data using DICOM editable software platforms are evaluated and a digital reference model in form of a STL network model with accurate localization of the hard and soft tissues defect is created; [0080] the extent of hard and soft tissue deformation is measured exactly on a digital reference model; [0081] based on a digital reference model, a digital personalized medical device is created; [0082] a clinically applicable model of a personalized multicomposite medical device is produced.

[0083] The preparation of a personalized medical device takes place in the prenatal period and postnatal period. The prenatally prepared device can be immediately administered postnatally to the newborn.

[0084] Prior to producing a clinically applicable model of the personalized medical device, a reference model of the deformity itself as well as a medical device model is additively produced, wherein there are validated dimensions on the reference models and are considered by consultation in terms of fixation and application parameters.

Example 2

[0085] The personalized medical device and method of its preparation according to this example of embodiment are identical to Example 1, except that a biocompatible thermoplastic material used as a hard tissue replacement in this example of embodiment is polymethyl methacrylate and a biocompatible elastic substance used as a soft tissue replacement in this example of embodiment is elastic silicone.

[0086] In this example of embodiment, the surface treatment of the hard tissue is solved by dipping.

Example 3

[0087] The personalized medical device and method of its preparation according to this example of embodiment are identical to Example 1, except that a biocompatible thermoplastic material used as a hard tissue replacement in this example of embodiment is polymethyl methacrylate and a biocompatible elastic substance used as a soft tissue replacement in this example of embodiment is polyurethane.

Example 4

[0088] The personalized medical device and method of its preparation according to this example of embodiment are identical to Example 1, except that a biocompatible thermoplastic material used as a hard tissue replacement in this example of embodiment is polypropylene sulfone and a biocompatible elastic substance used as a soft tissue replacement in this example of embodiment is elastic silicone.

Example 5

[0089] The personalized medical device and method of its preparation according to this example of embodiment are identical to Example 1, except that a biocompatible thermoplastic material used as a hard tissue replacement in this example of embodiment is polypropylene sulfone and a biocompatible elastic substance used as a soft tissue replacement in this example of embodiment is polyurethane.

Example 6

[0090] The personalized medical device and method of its preparation according to this example of embodiment are identical to Example 1, except that it is an implantable medical device and a biocompatible thermoplastic material used as a hard tissue replacement in this example of embodiment is bioresorbable, osseointegratable polycaprolactone and a biocompatible elastic substance used as a soft tissue replacement in this example of embodiment is epithelial colony replacing the mucosa of the soft palate.

Example 7

[0091] The personalized medical device and method of its preparation according to this example of embodiment are identical to Example 1, except that it is an implantable medical device and a biocompatible thermoplastic material used as a hard tissue replacement in this example of embodiment are non-resorbable, osseointegratable polyaryl ketones and a biocompatible elastic substance used as a soft tissue replacement in this example of embodiment is epithelial colony replacing the mucosa of the soft palate.

Example 8

[0092] The personalized medical device and method of its preparation according to this example of embodiment are identical to Example 1, except that it is an implantable medical device and a biocompatible thermoplastic material used as a hard tissue replacement in this example of embodiment are non-resorbable, osseointegratable polyaryl ketones in combination with ceramics and a biocompatible elastic substance used as a soft tissue replacement in this example of embodiment is epithelial colony replacing the mucosa of the soft palate.

INDUSTRIAL APPLICABILITY

[0093] The industrial applicability of the invention is obvious. The personalized medical device according to this invention is intended in particular for correction of defects in the orofacial area and for its preparation in the prenatal period as well as in the postnatal period. However, the use of the invention is also possible for the production of personalized medical devices as a replacement for other parts of the human body.