CAD/CAM SURGICAL DEVICE AND USE THEREOF

Abstract

The present invention concerns a surgical device made by computer-aided design and manufacturing (CAD/CAM) and its use as a surgical guide.

Claims

1. A surgical device (100) having a structure provided with a plurality of openings (11), said device comprising at least one first surface (10) complementary to at least one organ of the subject subjected to surgery, and a second surface (20) opposite the first surface (10).

2. The surgical device (100) according to claim 1, comprising a plurality of guide grooves or tracks (14), wherein said guide grooves (14) are guide lines for the piezocision cuts.

3. The surgical device (100) according to claim 1, further comprising at least two holes (12).

4. The surgical device (100) according to claim 1, comprising from 100 to 800 openings (11).

5. The surgical device (100) according to claim 3, wherein said openings (11) have a surface area ranging from 0.005 cm.sup.2 to 1.125 cm.sup.2, and said holes (12) have a surface area greater than the surface area of said openings (11).

6. The surgical device (100) according to claim 1, wherein said first surface (10) is a contact surface complementary to a dental arch of the subject subjected to surgery and in that said second surface (20) is not in contact with said organ.

7. The surgical device (100) according to claim 1, wherein said structure provided with a plurality of openings (11) is a net-like structure.

8. The surgical device (100) according to claim 1, wherein said first surface (10) and said second surface (20) of said structure having a plurality of openings (11) are designed and produced by computer-aided design (CAD/CAM) (13).

9. A method of performing odontostomatological surgery operations with the surgical device (100) according to claim 1 as a surgical guide.

10. The method use according to claim 9 in piezocision operations.

11. The surgical device (100) according to claim 4, comprising from 200 to 700 openings (11).

12. The surgical device (100) according to claim 4, comprising from 300 to 600 openings (11).

13. The surgical device (100) according to claim 5, wherein said openings (11) have a surface area ranging from 0.125 cm.sup.2 to 1 cm.sup.2, and said holes (12) have a surface area greater than the surface area of said openings (11).

14. The surgical device (100) according to claim 5, wherein said openings (11) have a surface area of 0.125 cm.sup.2, and said holes (12) have a surface area greater than the surface area of said openings (11).

15. The method according to claim 10, wherein said piezocision operations are computer-guided piezocision.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0079] FIGS. 1 and 2 depict the surgical device of the invention.

DETAILED DESCRIPTION OF THE FIGURES

[0080] FIG. 1 depicts the surgical device 100 according to the computer-aided design (CAD/CAM), said surgical device 100 having a structure provided with a plurality of openings 11 and comprising a first surface 10 and a second surface 20, said second surface being opposite the first surface 10. The first surface 10 is a contact surface complementary to a dental arch of the subject subjected to surgery and is in direct contact with the teeth of the subject subjected to surgery and partially with the gums of said subject. The second surface 20 is an outer surface not in contact with said dental arch of the subject subjected to surgery. The openings 11 on the device 100 cross the second surface 20 and the first surface 10. The device 100 in FIG. 1 has triangular-shaped openings 11. The surgical device 100 has guide grooves 14, said guide grooves being guide lines for the piezocision cuts. A screenshot of the program used for the CAD/CAM design (13) of the surgical device 100 is shown in FIG. 1.

[0081] FIG. 2 depicts the surgical device 100 according to the computer-aided design (CAD/CAM), said surgical device 100 having a structure provided with a plurality of openings 11 and holes 12 and comprising a first surface 10 and a second surface 20, said second surface being opposite the first surface 10. The first surface 10 is a contact surface complementary to a dental arch of the subject subjected to surgery and is in direct contact with the teeth of the subject subjected to surgery and partially with the gums of said subject. The second surface 20 is an outer surface not in contact with said dental arch of the subject subjected to surgery. The openings 11 on the device 100 cross the second surface 20 and the first surface 10. Likewise, the holes 12 on the device 100 cross the second surface 20 and the first surface 10. The holes 12 are located to the left and right sides of the device 100. The device 100 in FIG. 2 has triangular-shaped openings 11 and circular-shaped holes 12. The surgical device 100 can optionally have a plurality of guide grooves (not shown in the Figure), said guide grooves being guide lines for the piezocision cuts. Two screenshots of the program used for the CAD/CAM design (13) of the surgical device 100 are shown in FIG. 2.

EXPERIMENTAL SECTION

Example 1: Design and Printing of a Surgical Guide According to the Invention

[0082] The surgical guide of the invention, having a structure provided with a plurality of openings and a plurality of guide grooves (or tracks) and comprising a first surface complementary to an upper or lower dental arch of a subject to be subjected to computer-guided piezocision surgery, was made by computer aided design and manufacturing (CAD/CAM) and printed by a 3D printer.

[0083] The impression of the vestibular fornix of a subject to be subjected to computer-guided piezocision surgery was taken to make the surgical guide according to the invention. The impression was taken by using known techniques. At this point, a three-dimensional model of the impression was acquired by using a 3D scanner (Easy Optical 3D scanner; Open Technologies, Rezzato) and the images were saved in a stereolithographic file format (STL file).

[0084] The patient was subjected to a cone-beam computed tomography (CBCT) by wearing a radiological fork to overlap the stl files of the optical scan of the plaster model of the dental arches and the stl file of the maxillary bones and teeth.

[0085] At this point, digital DICOM images were acquired by using the Cortex, Media Lab (Milan) software and the images of the jaw were converted into a 3D model and also saved as an STL file. The STL file of the vestibular fornix and the STL file of the jaw were overlapped and, by using the Cortex, Media Lab (Milan) 3D design software, guide grooves corresponding to the piezocision cuts were positioned in the virtual model.

[0086] Openings and holes were included on the virtual model of the surgical guide by using the Cortex software. The 3D model of the device of the invention was then printed with any 3D printer.

Example 2: Use of the Device of the Invention as Surgical Guide in Computer-Guided Piezocision

[0087] Six patients who were to be subjected to computer-guided piezocision surgery were divided into two groups of three. The first group was subjected to the piezocision operation with conventionally used surgical guides (having a uniform structure), whereas the second group was subjected to the piezocision operation with surgical guides according to the invention, which were made according to the method of Example 1.

[0088] The patients subjected to piezocision by using the surgical guide of the invention had a moderately mild post-operative discomfort, characterized by minimal swelling limited to 3 days following the operation and no pain.

[0089] The post-operative discomfort of the patients subjected to a piezocision by using the surgical guide having a net-like structure provided with a plurality of openings and holes was less than that experienced by the patients operated by using a conventionally used surgical guide.

[0090] The conventionally used surgical guide does not comprise openings and holes and led to thermal necrosis of the hard and soft tissues of the patients treated.