A REUSABLE AND ADJUSTABLE SURGICAL JIG SYSTEM FOR MANDIBLE TUMOR RESECTION AND RECONSTRUCTION

Abstract

The present disclosure describes a reusable and adjustable surgical jig system (100) for mandible tumor resection and reconstruction. The system 100 comprises base plates (1), L-shaped fixation plate (7), a straight-cut guiding member (10) and an angular-cut guiding member (14). The jig system 100 is formed by connecting plurality of base plates (1) to each other via the mechanical arrangement (6,13) and forming a U-shape structure, adapted for mounting and adjusting the various elements (7, 10, 14) either above or below the base plates (1), as desired for performing mandible tumor resection and reconstruction.

Claims

1. A reusable and adjustable surgical jig system 100 for mandible tumor resection and reconstruction with accurate resection of tumor and accurate fixation of implant or bone graft, the system 100 characterized in that, comprising: plurality of base plates (1); a L-shaped fixation plate (7); a straight-cut guiding member (10); and a angular-cut guiding member (14); wherein each base plate (1) comprises a measuring scale (5) and a slot along the length of the base plate (1) with a first base end (1a) and a second base end (1b), wherein the second base end (1b) is bent at an angle ranging from 110?-150? with respect to the first base end (1a), forming a shape of hairpin loop, wherein the slot enables mounting of the elements (7, 10, 14) of the system (100) either above or below the base plate (1) as desired; wherein the fixation plate (7), comprises a flat base portion (8) and elongated portion (9), wherein the flat base portion (8) is adapted to accommodate fixation elements (6, 13) and the elongated portion (9) is adapted to accommodate fixation element at plurality of positions in order to affix the said fixation plate (7) to/near diseased part of mandible for holding the system (100) completely and firmly, wherein surface of the elongated portion of the fixation plate (9) protrudes outwards at a point in order to accommodate variations in sizes and shapes of diseased part to be resected or mandible; wherein the straight cut guiding member (10) comprises a cutting slot (19) and a threaded portion bolt without head (20), wherein each straight-cut guiding member (10) enables the blade to perform only straight cuts for resection of diseased part of subject's mandible, wherein the cutting slot (19) comprises a close end (11) and open end (12), enabling entry and exit of the blade though the open end (12) for cutting, wherein the threaded portion bolt without head (20) is integrated at the closed end (11) of straight cut guiding member (10) and is further connected to the one of the base plates (1) via a mechanical arrangement at a position desirable for efficient resection of diseased part; wherein the angular-cut guiding member (14) comprises a cutting slot (19) and a threaded portion bolt without head (20), wherein each angular-cut guiding member (14) enables the blade to perform angular cuts by setting the guiding member (14) at a predefined angle for resection of diseased part of subject's mandible, wherein the cutting slot (19) enables entry and exit of the blade though the open end (16) for cutting, wherein the threaded portion bolt without head (20) is integrated at the closed end (15) of the angular-cut guiding member (14) and is further connected to the one of the base plates (1) via the mechanical arrangement and a L-shape pin (18), for resecting the diseased part at a predefined angle, ranging from 70-290 degrees, as desired; wherein the system 100 forms a U-shape structure by connecting the plurality of base plates (1) to each other via the mechanical arrangement (6, 13), adapted for mounting and adjusting the various elements (7, 10, 14) as desired by surgeon, for performing mandible tumor resection and reconstruction.

2. The jig system as claimed in claim 1, wherein the measuring scale (5) is engraved at the front side (3) of the base plate (1).

3. The jig system as claimed in claim 1, wherein the length of the base plate (1) is in a predefined range of 80-110 mm.

4. The jig system as claimed in claim 1, wherein the mechanical arrangement comprises a nut (6) and a bolt (13).

5. The jig system as claimed in claim 4, wherein the mechanical arrangement enables fixing and adjusting the elements (7, 10, 14) with respect to the base plate (1) as desired.

6. The jig system as claimed in claim 1, wherein the fixation plate (7) comprises variable outer diameter along the length of elongated portion (9) in order to accommodate variety of shapes and sizes of the diseased part for resection or the mandible.

7. The jig system as claimed in claim 1 comprises bushes (17) for altering the height of the angular-cut guiding member (14) as desired.

8. The jig system as claimed in claim 1 comprises bushes (17) for altering the height of the complete jig system 100 through the fixation plate (7).

9. The jig system as claimed in claim 1 comprises a L-shape pin (18), enabling angle rotation movement of the angular-cut guiding member (14).

10. The jig system as claimed in claim 1 comprises plurality of fixation elements such as nuts (6) and bolts (13), to affix the required elements (7, 10, 14) of the jig system 100 over the base plate (1).

11. The jig system as claimed in claim 1, wherein the material of the jig system 100 is selected from stainless steel, titanium, cobalt, chromium and Poly Ether Ether Ketone (PEEK).

12. A reusable and adjustable surgical jig system 100 for mandible tumor resection and reconstruction with accurate resection of tumor and accurate fixation of implant or bone graft, the system 100 characterized in that, comprising: plurality of base plates (1); a L-shaped fixation plates (7); and either a straight-cut guiding member (10) or an angular-cut guiding member (14) or both; wherein each base plate (1) comprises a measuring scale (5) and a slot along the length of the base plate (1) with a first base end (1a) and a second base end (1b), wherein the second base end (1b) is bent at an angle ranging from 110?-150? with respect to the first base end (1a), forming a shape of hairpin loop, wherein the slot enables mounting of the elements (7, 10, 14) of the system (100) either above or below the base plate (1) as desired; wherein the fixation plate (7), comprises a flat base portion (8) and elongated portion (9), wherein the flat base portion (8) is adapted to accommodate fixation elements (6, 13) and the elongated portion (9) is adapted to accommodate fixation element at plurality of positions in order to affix the said fixation plate (7) to/near diseased part of mandible for holding the system (100) completely and firmly, wherein surface of the elongated portion of the fixation plate (9) protrudes outwards at a point in order to accommodate variations in sizes and shapes of diseased part to be resected or the mandible; wherein the straight cut guiding member (10) comprises a cutting slot (19) and a threaded portion bolt without head (20), wherein each straight-cut guiding member (10) enables the blade to perform only straight cuts for resection of diseased part of subject's mandible, wherein the cutting slot (19) comprises a close end (11) and open end (12), enabling entry and exit of the blade though the open end (12) for cutting, wherein the threaded portion bolt without head (20) is integrated at the closed end (11) of straight cut guiding member (10) and is further connected to the one of the base plates (1) via a mechanical arrangement at a position desirable for efficient resection of diseased part; wherein the angular-cut guiding member (14) comprises a cutting slot (19) and a threaded portion bolt without head (20), wherein each angular-cut guiding member (14) enables the blade to perform angular cuts by setting the guiding member (14) at a predefined angle for resection of diseased part of subject's mandible, wherein the cutting slot (19) enables entry and exit of the blade though the open end (16) for cutting, wherein the threaded portion bolt without head (20) is integrated at the closed end (15) of the angular-cut guiding member (14) and is further connected to the one of the base plates (1) via the mechanical arrangement and L-shape pin (18) for resecting the diseased part at a predefined angle, ranging from 70-290 degrees, as desired; wherein the system 100 is formed by connecting the plurality of base plates (1) to each other via the mechanical arrangement (6, 13) and forming a U-shape structure, adapted for mounting and adjusting the various elements (7, 10, 14) as desired for performing mandible tumor resection and reconstruction.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0021] The accompanying drawings are included to provide a further understanding of the present disclosure, and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure. The diagrams are for illustration only, which thus is not a limitation of the present disclosure.

[0022] The detailed description is described with reference to the accompanying Figures. In the Figures, the left-most digit(s) of a reference number identifies the Figure in which the reference number first appears. The same numbers are used throughout the drawings to refer like features and components.

[0023] FIG. 1 illustrates a reusable and adjustable jig system 100 for accurate resection of tumor and accurate fixation of implant or bone graft, in accordance to an embodiment of the present disclosure.

[0024] FIG. 2 illustrates the perspective view of base plate (1) of the system 100, in accordance to an embodiment of the present disclosure.

[0025] FIG. 3 illustrates the perspective view of straight-cut guiding member (10) of the system 100, in accordance to an embodiment of the present disclosure.

[0026] FIG. 4 illustrates the perspective view of angular-cut guiding member (14) of the system 100, in accordance to an embodiment of the present disclosure.

[0027] FIG. 5 illustrates the perspective view of L-shape pin and bush of the system 100, in accordance to an embodiment of the present disclosure.

[0028] FIG. 6 illustrates the perspective view of fixation plate (7) of the system 100, in accordance to an embodiment of the present disclosure.

DETAILED DESCRIPTION

[0029] Some embodiments of this disclosure, illustrating all its features, will now be discussed in detail. The words comprising, having, containing, and including, and other forms thereof, are intended to be equivalent in meaning and be open ended in that an item or items following any one of these words is not meant to be an exhaustive listing of such item or items, or meant to be limited to only the listed item or items.

[0030] It must also be noted that, the singular forms a, an, and the include plural references unless the context clearly dictates otherwise. Although any methods similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present disclosure, the exemplary methods are now described. The disclosed embodiments are merely exemplary of the disclosure, which may be embodied in various forms.

[0031] Various modifications to the embodiment will be readily apparent to those skilled in the art and the generic principles herein may be applied to other embodiments. However, one of ordinary skill in the art will readily recognize that the present disclosure is not intended to be limited to the embodiments illustrated, but is to be accorded the widest scope consistent with the principles and features described herein.

[0032] The present disclosure relates to a reusable and adjustable surgical jig system for tumor resection and placement of implant/bone graft accurately. The reusable and adjustable surgical jig system enables accurately placing/fixation of implant/bone graft at a desired position with minimal surgeon's time, cost and customization for reusing and sterilizing in autoclave

[0033] FIG. 1 illustrates a reusable and adjustable jig system 100 for accurate resection of tumor and accurate fixation of implant or bone graft, in accordance to an embodiment of the present disclosure. The jig system 100 may comprise plurality of base plates (1), at least one L-shaped fixation plates (7), at least one straight-cut guiding member (10) and at least one angular-cut guiding member (14). The base plate (1) may comprise a measuring scale (5) and a hollow portion/slot along the length of the base plate (1) with a first base end (1a) and a second base end (1b). The hollow portion/slot may enable mounting of the various elements of the system 100, but not limiting to, such as bolts (6), nuts (13), bushes (17), straight-cut guiding members (10) and angular-cut guiding members (14). The elements (6, 17, 10, 14) of the system 100 may be mounted/connected either above or below the base plate (1) as desired. In one embodiment, the various elements (6, 17, 10, 14) may be placed above the base plate (1). In an exemplary embodiment, some of the elements (6, 17, 10, 14) may be placed above the base plate (1), while some of the elements (6, 17, 10, 14) may be placed below the base plate (1), as desired.

[0034] In an embodiment, the system 100 may comprise at least one base plate (1) for supporting other elements of the system 100 and diseased portion of patient to be resected, at least one fixation plate (7) mounted on the base plate (1) with fixation elements (6, 13) adapted to accommodate variations in shapes and sized of diseased portion or mandible contours/surfaces, wherein the fixation plate (7) may be affixed to/near the diseased portion in order to keep the complete surgical jig system 100 in a steady immovable position with respect to the diseased portion. The straight-cut guiding member (10) may be mounted on the base plate (1) via the fixation elements (6, 13) for resecting the diseased portion in straight angle. The angular-cut guiding member (14) may be mounted on the base plate (1) at desired position for resecting the diseased portion at an angle ranging from 70-290 degrees. The angular-cut guiding member (14) may be mounted/affixed to the base plate (1) via bushes (17) and L-shape pin (18) for facilitating the angular motion of angular cutter (14) in a desired direction.

[0035] In another embodiment, the jig system 100 may comprise plurality of base plates (1), at least one L-shaped fixation plates (7) and either at least one straight-cut guiding member (10) or at least one angular-cut guiding member (14) or a combination thereof.

[0036] FIG. 2 illustrates the perspective view of the base plate (1) of the system 100, in accordance to an embodiment of the present disclosure. The base plate (1) may be a straight plate, wherein the length of the base plate (1) is in a predefined range of 80 to 110 mm. The base plate (1) may comprise a hollow portion/slot, between front end (3) and back end (4), along the length of the base plate (1) with a first base end (1a) and a second base end (1b). The front end (3) of the base plate (1) may further comprise an engraved measuring scale (5) with millimeter and centimeter markings running through the entire length of the base plate (1). The measuring scale (5) may facilitate the mounting of the various elements of the system 100, (especially straight cutters (10) and angle cutters (14)) and adjust the positions as per requirement). The base plate (1) may bend/tilt inwardly at second ends (1b) at an angle ranging from 110-160 degrees in such a way that it forms a hairpin loop like structure.

[0037] During the surgery, the surgeon may use two base plates at a time (either two large base plates, or two small base plates, or one large and one small base plate) as per requirement and size of diseased portion. In such cases, the second base end (1b) of second base plate (1) may be coaxially coupled with second base end (1b) of the first base plate (1) by mechanical arrangement (6, 13) in such a way that it forms a U-shape structure which may be adapted for mounting various elements (7, 10, 14) and holding/supporting the jig system 100.

[0038] FIG. 3 illustrates the perspective view of straight-cut guiding member (10) of the system 100, in accordance to an embodiment of the present disclosure. The straight-cut guiding member (10) may comprise a cutting slot (19) and a threaded portion bolt without head (20). The straight-cut guiding member (10) may enable the blade (not shown in figures) to perform only straight cuts for resection of diseased part of subject's mandible. The cutting slot (19) may further comprise a close end (11) and open end (12), enabling entry and exit of the blade though the open end for the cutting. In one embodiment, the width of the cutting slot (19) may be in a predefined range of 1.5 to 2 mm through which a cutting blade may be inserted and perform the straight cut either on one side of the diseased portion or both sides of the diseased portion as per requirement.

[0039] The threaded portion bolt without head (20) may be integrated at the closed end (11) of the straight cut guiding member (10) and may be further connected to the at least one of the base plates (1) via a mechanical arrangement (6, 13) at a position desirable for efficient/required resection of the diseased part.

[0040] In one embodiment, the length of the straight-cut guiding member (10) may be in a predefined range of 58 to 72 mm. In an exemplary embodiment, the straight-cut guiding members (10) of specific lengths may be selected as per the requirement for implant/bone graft fixation.

[0041] FIG. 4 illustrates the perspective view of angular-cut guiding member (14) of the system 100, in accordance to an embodiment of the present disclosure. The angular-cut guiding member (14) may comprise a cutting slot (19) and a threaded portion bolt without head (20). The angular-cut guiding member (14) may further enable the blade (not shown in figures) to perform angular cuts by setting the guiding member (14) at a predefined angle for resection of diseased part of subject's mandible. The cutting slot (19) of the angular-cut guiding member (14) may enable entry of the blade though the open end (16) for cutting. The threaded portion bolt without head (20) may be further integrated at the closed end (15) of the angular-cut guiding member (14) and may be connected to the at least one of the base plates (1) via the mechanical arrangement (6, 13) and L-shape pin (18) for resecting the diseased part. In one embodiment, the bolt without head (20) may be attached at the front side of the angular-cut guiding member (14 through which said angular cutter (14) is mounted on L-shape pin (18) via a nut (13). The L-shape pin (18) may be further affixed/connected to at least one base plate (1) with the help of bolts (6) and nuts (13) as shown in FIG. 1.

[0042] In an embodiment, the angular-cut guiding member (14) may enable the cutting at angle in a predefined range of 70-290 degrees of the diseased portion. The angular-cut guiding member (14) may move freely from an angle 70 degree to 290 degrees in order to perform an accurate angular cut of diseased portion. In yet another embodiment, the length of the angular-cut guiding member (14) may be in a predefined range of 52 mm to 62 mm and may use as per requirement.

[0043] FIG. 5 illustrates the perspective view of L-shape pin and bush of the system 100, in accordance to an embodiment of the present disclosure. In one embodiment, The L-shape pin (18) may provide free movement in a required angle to the angular-cut guiding member (14) and assists in fixing/adjusting the angular-cut guiding member (14) with respect to the base plate (1) through the mechanical arrangement of bolts (6), nuts (13) and bushes (17). In an embodiment, the L-shape pin (18) may further enable angle rotation movement of the angular-cut guiding member (14).

[0044] In an embodiment, the height of the bush may vary in a predefined range from 5 mm to 20 mm. The diameter of the bush may be 11 mm. The height of the bush may further enable either to increase/decrease the height of the angular-cut guiding member (14) as per requirement or to increase/decrease the height of system (100) from the fixation plate (7) with one or more fixation elements (6, 13) as per requirement.

[0045] FIG. 6 illustrates the perspective view of fixation plate (7) of the system 100, in accordance to an embodiment of the present disclosure. In an embodiment, the fixation plate may comprise a flat base portion (8) and elongated portion (9). The flat base portion (8) may enable connecting at least one fixation element (6, 13) and the elongated portion (9) may enable at least one fixation element at plurality of positions in order to affix the fixation plate (7) to diseased part of mandible for holding the system completely and firmly with respect to the diseased portion. The base portion (8) may be either adapted to affix either directly to the base plate (1) in parallel plane, or with nuts (6) and bolts (13), or bush (17), or any combination thereof.

[0046] In an embodiment, the elongated portion (9) may be perpendicular to said base portion (8). The elongated portion (9) of the fixation plate (7) may comprise variable outer diameter along the length of elongated portion (9) in order to accommodate variety of shapes and/or sizes of the diseased part or mandible contours/surfaces for resection. It can be said that, the surface of the elongated portion (9) of the fixation plate (7) may protrude outwards at a point in order to accommodate variations in sizes and shapes of diseased part/portion to be resected. In yet another embodiment, the outer diameter of the elongated portion (9) may vary throughout the entire length of elongated portion.

[0047] Furthermore, the system 100 is completely adjustable and reusable by sterilizing in autoclave similar to other surgical instruments, and hence the system 100 minimizes the surgeon visits and eventually the cost for customized and non-reusable jigs devices. The system 100 may be manufactured using the materials like, but not limited to, stainless steel, titanium, cobalt, chromium, Poly Ether Ether Ketone (PEEK) or any combination thereof.

[0048] In yet another embodiment, the surgical jig system 100 may provide efficient resection and/or accuracy in implant/bone graft placement/fixation as per the requirements.

[0049] In yet another embodiment, the method for guiding the mandible tumor resection by utilizing a surgical jig 100 is described. The method may comprise a step of selecting a two base plates (1) of variable length as per the requirement and connecting the base plates (1) via mechanical elements (6, 13) after mounting of the fixation plate (7) is carried out. The method may comprise a step of selecting a fixation plate (7) of a desired length and affixing the fixation plate (7) to/near the diseased portion on a rapid prototyping (RP) assisted diseased model, as per the space available near one of the guiding members (10, 14) either on one side or both sides in order to achieve more sturdy fixation. The rapid prototyping (RP) assisted diseased model may be created by referring the X-ray/CT scan image of the mandible area of the patient. The fixation plate (7) may be mounted by the surgeon on the rapid prototyping (RP) assisted diseased model, which further assists in mounting the connected base plates (1). The base plates (1) may be affixed with the fixation plate (7) and positioned either over or below the the fixation plate (7), as desired for the surgery. The fixation plate (7) and the base plates (1) may be affixed either via nuts (6) and bolts (13), or bush (17), or any combination thereof. The method may comprise a step of adjusting the base plates (1) as per the shape of diseased portion and tighten the nut (13) in order to restrict the movement of the base plates (1), followed by fixing/adjusting the guiding members (10, 14) at desired positions via the mechanical elements (6, 13). The method may comprise a step of removing the system 100 from the RP assisted diseased portion, by loosening the screws of the fixation plate (7) and without disturbing the position of the guiding members (10, 14), in order to sterilize the complete assembly using an autoclave. The method may comprise a step of fixing/placing the sterilized assembly directly at the required/actual surgery site by the surgeon, with the same positions of the guiding members (10, 14) as placed over the RP assisted diseased model) the system 100. Further, the surgeon may cross check the position of the guiding members (10, 14) with the available scale (5) present on the base plate (1). After confirmation of the position of the guiding members (10, 14), the surgeon may perform the resection of the tumor via the guiding members (10, 14). After the tumor cutting/resection is completed, the surgeon may loosen the fixation plate screws/bolts/nuts, remove the complete jig system 100 from the mandible area of patient, dissemble the all elements (7, 10, 14) of the jig system 100 and, followed by washing and sterilizing the jig system 100 properly for its next use. In an embodiment, the surgeon may perform the mandible reconstruction by fixing of an implant or bone graft, enabling the jig system 100 to be present in the mandible area of the patient, followed by loosening of the fixation plate screws/bolts/nuts, removing the complete jig system 100 from the mandible area of patient, dissembling the all elements (7, 10, 14) of the jig system 100 and, followed by washing and sterilizing the jig system 100 properly for its next use.

[0050] Hence, a smart, reusable, autoclavable, modular surgical jig system for tumor resection and implant positioning/fixation of provides an alternative to customized and non-reusable surgical jig which is cost effective, easy to operate, eliminating the need of frequent visits to surgeon and customized designing as per patient specifications.

[0051] In accordance with embodiments of the present disclosure, the reusable and adjustable adjustable jig system 100 for accurate resection of tumor and accurate fixation of implant or bone graft, described above may have following advantages including but not limited to: [0052] ReusableCan be used for multiple patients after sterilization [0053] Adjustablecan be used for any shape and size of tumor [0054] High strength due to manufacturing in metal [0055] Can be used to resect tumor available on any location of mandible [0056] Can be used in emergency cases [0057] Cost effectiveno separate designing of the jig system is required. [0058] Intraoperative adjustment is possible [0059] Easily autoclavable [0060] Mounting of all members can be above or below the base plate. [0061] Ease of installationOnly fixation plate is attached to the mandible. [0062] Intraoperative adjustment is also possible. [0063] Height adjustment of the jig system and/or the cutting members is possible by inserting/adding bushes.

[0064] The embodiments, examples and alternatives of the preceding paragraphs or the description and drawings, including any of their various aspects or respective individual features, may be taken independently or in any combination. Features described in connection with one embodiment are applicable to all embodiments, unless such features are incompatible.

REFERENCE NUMERALS IN THE FIGURES

[0065]

TABLE-US-00001 Legend Description 100 Complete system of present invention 1 Base plate 1a First base end of base plate 1b Second base end of base plate 3 Front end of base plate 4 Back end of base plate 5 Measuring scale 6 Bolts 7 Fixation plate 8 Base portion of fixation plate 9 Elongated portion of fixation plate 10 Straight-cut guiding member 11 Close end of straight-cut guiding member 12 Open end of straight-cut guiding member 13 Nuts 14 Angular-cut guiding member 15 Close end of angular-cut guiding member 16 Open end of angular-cut guiding member 17 Bush(es) 18 L-shape Pin 19 Cutting slot 20 Bolt without head