Abstract
A titanium screw that permits the adaptation of PEEK (polyether ether ketone) capsules at both ends, enabling vertical and horizontal, uni or bidirectional appositional bone reconstructions. The screw has a length selected between 6, 8 and 10 mm; whereas the PEEK capsules have a diameter of 4.5 mm and a height of 1.5 mm. Accordingly, it is possible to retract the soft tissue and maintain the space necessary for bone reconstruction. By minimizing compression to the bone graft, this device optimizes tissue reconstruction, oftentimes crucial for the placement of implants.
Claims
1.-3. (canceled)
4. A device for retracting soft tissue for appositional bone reconstruction, the device designed for application in appositional bone reconstruction surgeries in implant dentistry; and the device comprising: a titanium screw with variable length and peek capsules configured to be incased at both ends of the titanium screw); wherein the titanium screw has a length selected between 6, 8 and 10 mm and the peek capsules have a diameter of 4.5 mm and a height of 1.5 mm.
5. The device for retracting soft tissue for appositional bone reconstruction of claim 4, wherein the titanium screw has a length of the threadable area varying between 8 mm, 6 mm or 4 mm; and the ends of the screw present a hexagonal structure of 1.2 mm.
6. The device for retracting soft tissue for appositional bone reconstruction of claim 5, wherein the peek capsule is endowed with an internal encasement for adaptation to the hexagonal structure featured at the end of the screw.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The invention will now be described in its preferred embodiment, and for improved understanding, references will be made to the accompanying drawings, in which the following are represented:
[0014] FIG. 1 shows a perspective design of the titanium screw that is the object of the device of the invention;
[0015] FIG. 1a shows the titanium screw that is the object of the device of the invention in a side view, with top and bottom views;
[0016] FIG. 1b shows the titanium screw that is the object of the device of the invention in a side view, at a rotated angle relative to the preceding figure;
[0017] FIG. 2 shows a PEEK capsule in top view;
[0018] FIG. 2a shows a PEEK capsule according to the A-A cut indicated in the preceding figure;
[0019] FIG. 3 shows a pre-operatory clinical situation of the first clinical case, with significant bidirectional horizontal bone loss (buccal and palatal) and the need for tissue reconstruction prior to installing the implants;
[0020] FIG. 4 shows after surgical access to the bone defect, the clear need for bone reconstruction both from a buccal as well as a palatal aspect;
[0021] FIG. 5 shows, subsequently to creating minor perforations in the receiver bone to stimulate bleeding, making three perforations with drills measuring 1.1 mm in diameter, for the insertion of three titanium screws, illustrated therein;
[0022] FIG. 6 shows the titanium screws fastened, with PEEK capsules adapted at both ends of the aforementioned screws;
[0023] FIG. 7 shows, after installing the device, the insertion of the particulate bone graft;
[0024] FIG. 8 shows the coating of the area of the preceding figure with resorbable hydrophilic membrane;
[0025] FIG. 9 shows the application of the suture;
[0026] FIG. 10 shows the open region, after the bone healing period (about six months), for the removal of the devices of the invention;
[0027] FIG. 11 shows the installation of the implants;
[0028] FIG. 12 shows a second clinical case in which a trans-operatory clinical image, with significant unidirectional horizontal bone loss (just by buccal) and need for tissue reconstruction prior to installing the implants; in this figure the device of the invention has already been installed, through the use of a screw 6 mm in length, since the need is solely the reconstruction of one side (buccal);
[0029] FIG. 13 shows, in the second clinical case, the adaptation of the particulate bone graft;
[0030] FIG. 14 shows, in the second clinical case, the coating with resorbable hydrophilic membrane; in this case, a PEEK capsule was optionally adapted on the outside of the membrane, helping to immobilize it;
[0031] FIG. 15 shows a pre-operatory clinical situation of a third clinical case, with significant unidirectional vertical and horizontal bone loss (buccal) and need for tissue reconstruction prior to installing the implants;
[0032] FIG. 16 shows, after surgical access, in the third clinical case, the installation of two devices (one to enable the vertical tissue decompression and the other horizontal), both screws 6 mm in length;
[0033] FIG. 17 shows, in the third clinical case, the bone graft positioned;
[0034] FIG. 18 shows, in the third clinical case, the arrangement of a resorbable hydrophilic membrane used to coat the entire grafted area;
[0035] FIG. 19 shows, in the third clinical case, the sutured region.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0036] The device for retracting soft tissue for appositional bone reconstruction, object of this patent application, refers to a single device designed for application in appositional bone reconstruction surgeries in implant dentistry; the device comprises a titanium screw (1) with variable length and PEEK capsules (2) capable of being incased at both ends of the aforementioned screw (1).
[0037] Technically, for the installation of the screws (1) and PEEK capsules (2) there is a need to use a surgical Kit, which contains drills for preparing the bed that will receive the screws (1), drivers for installing the aforementioned screws (1), as well as an applied instrument of PEEK capsules (2), which can be positioned beneath or outside the resorbable membrane (M).
[0038] The device that is the object of the present invention and its respective installment Kit makes it possible to perform surgeries for horizontal uni or bidirectional, and vertical appositional bone augmentation in a safe and predictable manner. The device structure prevents excessive compression of the overlying soft tissue and permits the maintenance of the particulate bone grafts in position and suitable stability during the entire healing process.
[0039] FIGS. 1 to 2a show specific details of the screw (1) and of the PEEK capsule (2) that form the device of the invention, and the screw (1) has a length selected between 6, 8 and 10 mm; whereas the PEEK capsules (2) have a diameter of 4.5 mm and 1.5 mm in height.
[0040] Further according to FIGS. 1 to 1b, the screw (1) will have the length of the threadable area varying between 8 mm, 6 mm or 4 mm; while the ends of the screw (1) present a hexagonal structure (3) measuring 1.2 mm.
[0041] FIGS. 2 and 2a refer to the PEEK capsule (2), which, as stated, has a capsule diameter of 4.5 mm and height of 1.5 mm, being endowed with an internal encasement (4) that permits adaptation to the hexagonal structure (3) featured at the end of the screw (1).
[0042] It is important to emphasize that prototypes of the device for retracting soft tissue for appositional bone reconstruction (Barbell Technique) were produced and used in certain surgical procedures, which enabled the publication of the scientific article entitled “Barbell Technique™: a novel approach for bidirectional bone augmentation. Technical Note.”, as previously cited in the specification of the invention. In sequence, we make use of images of the step-by-step surgery to illustrate how the device is utilized. FIGS. 3 to 11 illustrate a clinical case of bidirectional horizontal bone augmentation; FIGS. 12 to 14 demonstrate a case of unidirectional horizontal bone augmentation and FIGS. 15 to 19 a case of vertical bone augmentation, whereby illustrating the technical versatility of the device.
[0043] In more detailed fashion, FIG. 3 illustrates a pre-operatory clinical situation of the first clinical case, with significant bidirectional horizontal bone loss (buccal and palatal) and need for tissue reconstruction prior to installing the implants. After surgical access to the bone defect, there is a clear need for bone reconstruction both from a buccal as well as a palatal aspect, in accordance with FIG. 4.
[0044] Subsequently to creating minor perforations in the receiver bone to stimulate bleeding, three perforations were made with drills with 1.1 mm in diameter for inserting three titanium screws (1) of the device (FIG. 5). To insert these screws (1), specific drivers were used (which fit onto the head of the screws). In this clinical case, since the requirement was bidirectional augmentation, 10 mm screws (1) were used, transfastening the receiver bone, keeping about 5 mm of screw exposed by buccal and about 3 mm by palatal (since the thickness of the residual bone was about 2 mm). As soon as the screws (1) are fastened, PEEK capsules (2) are adapted at both ends of the screws, as shown in FIG. 6.
[0045] With the installation of the devices, the particulate bone graft (FIG. 7) is inserted and the area coated with resorbable hydrophilic membrane (M) (FIG. 8).
[0046] FIG. 9 shows the suture (S) performed after conclusion of the stages described above.
[0047] After the bone healing period (in this case about 6 months) the region is reopened to enable the removal of the devices and installation of the implants (FIGS. 10 and 11).
[0048] FIG. 12 shows a trans-operatory clinical image of the second clinical case, with significant unidirectional horizontal bone loss (just by buccal) and need for tissue reconstruction prior to installing the implants. This image shows the device already installed. A screw (1) just 6 mm in length was used since the need was for reconstruction of just one side (buccal). FIG. 13 shows the adaptation of the particulate bone graft.
[0049] FIG. 14 shows the coating with resorbable hydrophilic membrane (M). In this case, a PEEK capsule (2) was optionally adapted on the outside of the membrane, helping to immobilize it.
[0050] FIG. 15 illustrates a pre-operatory clinical situation of the third clinical case, with significant unidirectional vertical and horizontal bone loss (buccal) and need for tissue reconstruction prior to installing the implants.
[0051] After surgical access, two devices were installed (one for enabling vertical tissue decompression and the other horizontal), as illustrated in FIG. 16. Both screws (1) were 6 mm in length.
[0052] Subsequently, the particulate bone graft was positioned (FIG. 17) and a resorbable hydrophilic membrane (M) was used to coat the entire grafted area (FIG. 18).
[0053] FIG. 19 shows the region finally sutured (S), after the sequence of procedures described as of FIG. 15.
[0054] The three clinical cases presented illustrate the versatility of the art, based on using the device according to the invention, for usage in appositional bone augmentations both bidirectional horizontal (clinical case 1), and unidirectional horizontal (clinical case 2) and vertical (clinical case 3).
