SURGICAL GUIDES WITH REMOVABLE INSERTS

Abstract

The present disclosure describes a surgical guide comprising a cutting guide defining a plurality of cutting slots and including at least one removable insert positioned between the plurality of cutting slots. The at least one removable insert defines an aperture which is designed to receive a surgical fastening device. The surgical guide further comprises a template guide which defines a feature. The at least one removable insert is designed to fit in the template guide at least in part using the feature.

Claims

1. A surgical guide, comprising: a cutting guide defining a plurality of cutting slots and comprising at least one removable insert positioned between the plurality of cutting slots, wherein the at least one removable insert defines an aperture which is designed to receive a surgical fastening device; and a template guide defining a feature, wherein the at least one removable insert is designed to fit in the template guide at least in part using the feature.

2. The surgical guide of claim 1, wherein the cutting guide is designed to secure to an underlying bone via apertures defined on distal and proximal ends of the surgical guide.

3. The surgical guide of claim 1, wherein the surgical fastening device is configured to secure a resected bone with the cutting guide.

4. The surgical guide of claim 1, wherein the feature comprises a recess portion.

5. The surgical guide of claim 1, wherein the cutting guide comprises a plurality of removable inserts, and wherein the template guide also comprises a plurality of features, and wherein the plurality of features are designed so as to mate with the plurality of removable inserts so as to connect a plurality of resected bones to their target angles.

6. The surgical guide of claim 1, wherein the plurality of cutting slots are designed so as to produce desired bone-to-bone contact angle between a plurality of resected bones.

7. The surgical guide of claim 1, wherein the at least one removable insert is designed to disconnect from the cutting guide and to fit with the feature defined in the template.

8. A surgical guide, comprising: a cutting guide having one or more removable inserts, the cutting guide configured to be placed over a fibula bone and facilitate extraction of one or more resected fibula bone portions, with each of said bone portions having a removable insert of the one or more removable inserts secured thereon; and a template guide configured to be positioned at a mandibular reconstruction site and designed to mate with the one or more removable inserts having one or more resected fibula bone portions secured thereon and to align the one or more resected fibula bone portions to reconstruct at least part of a mandible.

9. The surgical guide of claim 8, wherein the cutting guide further includes one or more cutting slots defined alongside at least one of the one or more removable inserts.

10. The surgical guide of claim 9, wherein the one or more cutting slots are sized to receive a cutting tool which is to resect the fibula bone to extract the one or more resected fibula bone portions.

11. The surgical guide of claim 8, wherein the template guide is configured to mate with each of the one or more removable inserts for a desired placement of the one or more resected fibula bone portions at the mandibular reconstruction site.

12. The surgical guide of claim 8, wherein the template guide includes features that mate with the removable insert of the one or more removable inserts.

13. The surgical guide of claim 8, wherein the cutting guide further includes apertures defined on distal and proximal ends of the cutting guide, and wherein the apertures are designed to receive fixating devices to secure the cutting guide to the fibula bone.

14. A method of manufacturing a surgical guide, comprising: accessing a computer-readable medium having stored thereon three-dimensional (3D) images of a cutting guide and a template guide; fabricating the cutting and template guides based on their 3D images, wherein the fabricating the cutting and template guides include: fabricating the cutting guide having a plurality of cutting slots and at least one removable insert positioned between the plurality of cutting slots; and fabricating the template guide having at least a feature, wherein the feature is fabricated to attach with the at least one removable insert.

15. The method of claim 14, wherein the 3D image includes a 3D model of the surgical cutting guide derived using magnetic resonance image (MRI) of the biological structure.

16. The method of claim 14, wherein the fabricating is performed using 3D printing techniques.

17. The method of claim 14, wherein the fabricating the cutting guide includes fabricating the cutting guide having one or more apertures defined thereon.

18. The method of claim 17, wherein the one or more apertures include holes that are configured to receive surgical fixating devices that secure the cutting guide on a biological structure.

19. The method of claim 14, wherein the at least one removable insert defines one or more apertures thereon, and wherein the one or more apertures are designed to receive surgical fixating devices to secure a resected biological structure underneath the at least one removable insert.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] For a more complete understanding, reference is now made to the following descriptions taken in conjunction with the accompanying drawings, in which:

[0012] FIG. 1(a) depicts an anterior view of a patient's leg;

[0013] FIG. 1(b) depicts a front-view of the patient's skull;

[0014] FIGS. 2(a)-2(c) depict a cutting guide (and portions thereof), in accordance with embodiments of the present disclosure;

[0015] FIGS. 3(a)-3(c) depict a template guide that may be used by surgeon to facilitate reconstruction of a defect at the reconstruction site, in accordance with embodiments of the present disclosure;

[0016] FIG. 4 depicts an illustrative method that may be used to design and manufacture patient-specific surgical guides, in accordance with embodiments of the present disclosure;

[0017] FIG. 5 depicts an illustrative method that may be implemented by a surgeon using the surgical guides during a reconstruction procedure, in accordance with embodiments of the present disclosure.

DETAILED DESCRIPTION

[0018] For the sake of illustration and clarity, this disclosure describes surgical guides that may be used during mandible-related reconstruction procedures using fibula as a donor bone. However, it should be appreciated that the disclosure is not intended to be limited to the examples and designs of surgical guides used for mandible-related procedures or particular donor sites, but is to be accorded the widest scope consistent with the principles and novel features of the surgical guides disclosed ahead. Thus, the description ahead is provided to enable any person skilled in the art to make or use the disclosure. Various modifications to the disclosure will be readily apparent to those skilled in the art, and the generic principles of the use and manufacturing of surgical guides defined herein may be applied to other variations as well (e.g., using the invention while performing a different reconstruction procedures (e.g., maxillary-related) using different donor bones (e.g., collar bone)).

[0019] The disclosure first refers to FIGS. 2(a)-2(c), which depict a cutting guide (or a portion thereof) that may be used to resect one or more bones from a donor site. The disclosure then refers to FIGS. 3(a)-3(c), which depict a template guide that may be used by surgeon to facilitate reconstruction of the defect at the reconstruction site.

[0020] Referring now to FIG. 2(a), a 3D rendered image 200 of fibula 210 with cutting guide 215 positioned thereon is shown. Fibula 210 may be chosen by a surgeon during the planning phase of the reconstruction procedure, e.g., after determining that the cross-section of fibula 210 is substantially similar to the cross-section of the patient's original mandible bone. In other embodiments, the surgeon may choose a different bone from the patient's body, such as clavicle bone, hip bone, or ribs to reconstruct the mandibular defect. Cutting guide 215 may be designed to be positioned on fibula 210. For example, cutting guide 215 may include a contact surface designed to imitate or follow at least a portion of a contour of the donor bone (e.g., fibula 210). In aspects, at least a portion of the contour of the contact surface may be viewed as a negative of the surface of the underlying fibula 210. The imitating structure/design of the cutting guide 215 may help ensure proper positioning and orientation (e.g., during initial placement) of the cutting guide 215.

[0021] Cutting guide 215 defines apertures 205, which are designed to receive surgical fastening devices (e.g., surgical screws and/or wires) to secure cutting guide 215 to underlying fibula 210. In some embodiments, apertures 205 may be present on frontal and distal ends of fibula 210. In operation, a surgeon may use apertures 205 to secure cutting guide 215 at its proper position on the underlying bone. Cutting guide 215 may have top surface 204(a), which defines a plurality of cutting slots thereon, such as cutting slots 216-220. The cutting slots may be designed and dimensioned to receive a cutting blade of a cutting instrument (e.g., saw blade). In some embodiments, the design and orientation and/or shape and/or obliquity of the cutting slots 216-220 may depend on a desired bone-to-bone contact angle between the resected bones at the reconstruction site. For example, one or more of cutting slots 216-220 include slots that are oriented at specific angles so as to resect the underlying fibula 210 at angles that facilitate assembling the resected bones at the reconstruction site by having the desired bone-to-bone contact between the resected bones.

[0022] Cutting guide 215 may also include removable inserts 225, 230, and 235, which are designed to be able to be taken off or removed from the position occupied. In embodiments, the removable inserts forms a fit (e.g., snap-fit) with portions of guide 215 contiguous to the removable inserts. For example, for example, by exerting some force (e.g., by hands or using surgical hammer), the surgeon may remove removable inserts 225, 230, and 235 from their occupied positions. Removable inserts 225, 230, and 235, in embodiments, form interference-based connections (or fits) with portions of guide 215 contiguous to the removable inserts. An interference-based connection/fit, also sometimes referred to as a friction fit, is an example removable securing technique that connects two parts (e.g., removable inserts and the contiguous portions of the cutting guide 215), via friction, after the parts are pushed together, rather than by any other means of fastening. However, in other embodiments, a combination of interference fit and other means of fastening (e.g., surgical wires or screws, snap fit, and the like) may be used. The strength of interference required to connect or disconnect the two parts may result in different types of interference connections, such as a loose connection, or light interference connection. In some embodiments, the strength depends on the type of material used to manufacture the guide, the size of the connecting parts, and the desired degree of tightness. In other embodiments, the removable inserts may form connections with portions of guide 215 through other kinds of fits, such as a clearance fit. Examples of clearance fits include loose running fit, easy running fit, close running fit, etc. Achieving a clearance fit may require less force than a friction fit.

[0023] Removable inserts 225, 230, and 235 may define apertures thereon designed to receive surgical fastening devices (e.g., surgical screws and/or wires) to secure respective removable inserts to the underlying fibula 210. For example, removable insert 225 may include apertures 226 and 227; removable insert 230 may include apertures 231 and 232; and removable insert 235 may include apertures 236 and 237. In operation, after securing cutting guide 215 onto fibula 210, the surgeon may secureusing surgical fastening devicesremovable inserts 225, 230, and 235 to fibula 210. The surgeon may then resect fibula 210 by using cutting tools via cutting slots 216-220 and form resected bones 210a, 210b, and 210c. The resected bones are depicted in FIG. 2(b), which shows a back view of cutting guide 215. The resected bones are secured to a second surface (or the contact surface) 204(b), which is the surface behind first surface 204(a), via surgical fastening devices that were used to secure removable inserts to fibula 210. Since resected bones 210a, 210b, and 210c are secured to removable inserts 225, 230, and 235, respectively, some force exerted to removable inserts 225, 230, and 235 may also remove the resected bones secured therewith (see FIG. 2(c)). In some embodiments, removable inserts may also include mating or connecting features, the use of which is described ahead.

[0024] Referring to FIG. 3(a), template guide 300 that serves as a pattern that facilitates reconstructing the desired mandible defect is shown. Template guide 300 includes recess portions 305, 310, and 315, which are designed to mate (or couple) with the removable inserts so as to position or assemble the resected bones secured to the removable inserts at the reconstruction site. For instance, as shown in FIG. 3(b), removable insert 235 may couple with recess portion 305; removable insert 230 may couple with recess portion 310; and removable insert 225 may couple with recess portion 315. In some embodiments, the recessed portions include additional features that may strengthen the connection between removable inserts and the recessed portions. For example, recessed portion 310 include features 308 and 309, which are protruding features and are sized to fit with apertures 231 and 231, respectively, to improve the connection between recessed portion 310 and removable insert 230.

[0025] Template guide 300 is designed such that coupling the removable inserts with their respective recess portions assembles the resected bones at desired positions and reconstructs the curvature of the defective mandible. In embodiments, the recess portions are designed to mate with their respective removable inserts so as to connect the resected bones to their target angles (e.g., see FIG. 3(b)). For example, following resecting the fibula using the one or more of cutting slots 216-220 (which are oriented at specific angles so as to resect the underlying fibula 210 at angles that facilitate the desired bone-to-bone contact between the resected bones), the recessed portions mate with their respective removable inserts affixed with resected bones to connect the resected bone at their target angles.

[0026] In some embodiments, the coupling (or mating) of the removable inserts and their respective recessed portions may also form an interference-based connection. For example, to connect removable insert 230 with recess portion 310, the surgeon may slide (e.g., via tongue and groove type features) the mating feature of the removable insert 230 into the mating feature of the recess portion 310; and in order to disconnect removable insert 230 from the recessed portion 310, the surgeon may slide removable insert 230 out of recess portion 310. In other embodiments, removable inserts and recess portions may form other forms of fits, such as interference fit, clearance fit, button fit, snap fit, and the like.

[0027] Referring now to FIG. 3(c), with the improved surgical guide, the reconstruction may be performed by approximating the position of the complete structure shown in FIG. 3(b) to the left and right zygomatic bones 320 and 325, respectively and then affixing resected bones 210a, 210b, and 210c using surgical fastening devices, e.g., surgical screws and plates (not shown in FIG. 3(c)), to the zygomatic bones. The surgeon may first transplant the combined structure to the reconstruction site (i.e., the mandible region) where the surgeon may first fasten resected bones 210a to left zygomatic bone 320 and 210c to right zygomatic bone 210c. The surgeon may then complete the securing by fastening resected bone 210b with resected bones 210a and 210c using surgical plates and surgical fastening devices. After securing the resected bones, the surgeon may begin disassembling the combined structure. The disassembling process may include first removing template guide 300, e.g., by sliding it off the removable inserts, and then unscrewing the removable inserts from the resected bones, which may be followed by removing removable inserts.

[0028] Embodiments of surgical guide described above may be patient-specific. Patient-specific guides including a cutting guide and a template guide are individually designed and adapted to the patient's body anatomy such that, during reconstruction procedure, the surgeon would ultimately lead to a seamless donor bone and reconstruction bone continuity. However, in some cases, embodiments described above may provide for surgical guides which are not patient specific, meaning that the surgical guides are not designed for a specific patient, but are generically designed. Thus, the same design can be used to produce multiple surgical guides, which can further be used during reconstruction procedures of different patients. In some embodiments, these non-patient-specific surgical guides may be designed based on age, gender, or generic physical makeup of the human anatomical structure. As such, the non-patient-specific surgical guides may come in different sizes, e.g., small-male, small-female, medium-male, medium-female, large-male, and large-female. By way of example, a medium-male design may be used during a reconstruction procedure of a 5 foot 6 inch, 30 year old man, whereas, a large-male design may be used during a reconstruction procedure of a 6 foot, 30 year old man.

[0029] FIG. 4 depicts an illustrative method 400 that may be used to design and manufacture patient-specific surgical guides. In some cases, method 400 may be performed, without limitation, by a medical institution (e.g., a hospital) where the reconstruction surgery will eventually take place. In other cases, method 400 may be performed by a contracted third party (e.g., a medical device company) that works with the medical institution to generate and manufacture patient-specific surgical guides.

[0030] In some embodiments, method 400 begins with block 410 that includes receiving a patient's data for one or more donor and reconstruction sites. Patient-specific information, in some examples, includes one or more electronic images and/or measurements of the surface of both the donor site (e.g., fibula) and the reconstruction site (e.g., mandible region). Images and measurements of both sites, in one embodiment, may provide coordinates that define the surface and shape of the sites. The electronic images of the sites may be from, without limitation, a CT image, a spiral CT image, an MRI image, an ultrasound scan, digital tomosynthesis, or optical coherence tomography. The received patient data, in one embodiment, may then be utilized to generate 3D bone models of both the donor and reconstruction sites. The 3D bone model, in one embodiment, is generated using a computer system configured to receive the images and/or other details and generate the bone model (e.g., of both the fibula and the mandible) using a software system installed in the computer system. The 3D bone model may then be subsequently used in surgical planning by the surgeon performing the procedure. The surgical planning may include discussions regarding the amount of bone resection required (from the clinical and radiological data, i.e., CT scan and MRI) considering at least some (e.g., 3 cm) margin for the osteotomy to fix the plates to the resected bones; the side of fibula that will be used to resect the bones (e.g., the top side, bottom side, etc.); the number of resected bones and bone lengths; fibula and customized plate in setting and final position in relation to the remaining mandible and craniofacial skeleton; the degree of obliquity of the osteotomies both on the mandible and fibula; the number and position of screw holes both on the mandible and fibular segments; and the shape and position of cutting guides.

[0031] Method 400 may then move to block 420 that includes simulating, in the computer system, osteotomy lines on the 3D bone model of the patient. In some cases, the surgeon may virtually operate (e.g., resect) on the donor bone and reconstruct, at the reconstruction site, the desired bone structure using the resected bones. Method 400 may then move to block 430 that includes generating cutting and template guides that will be used by the surgeon during the procedure. In some embodiments, block 430 includes defining one or more boundaries of both the cutting and template guides. The boundaries of the guides, in some embodiments, are based on one or more input parameters, which may be provided by the surgeon. In some embodiments, the user of block 410 extrapolates relevant input parameters from the images and/or other details received in block 410. In some embodiments, the parameters may include minimum and maximum thicknesses of the desired bone, size of the osteotomy line, and the size of the apertures.

[0032] In one embodiment, surgical guides are manufactured using additive technology or freeform fabrication. In this method of manufacture, the surgical guides are formed through successive fusion of chosen parts of powder layers applied to a worktable. In some embodiments, PA 12 (also known as Nylon 12) is used as the powder. The surgical guides formed using PA 12 have high tensile strength, impact strength, and are able to flex without fracture. In other embodiments, other types of material may be used. In summary, once the patient-specific information is ascertained, rapid prototyping or other manufacturing techniques may be used to adapt the surgical guide to the patient's particular biological structure. In some embodiments, a mold may be made to form the surgical guide. In some embodiments, a surgical guide may be manufactured using a 3D printing technology disclosed in co-pending U.S. patent application Ser. No. 16/378,446, entitled System and Method for Forming Material Layers for Surgical Applications, and filed by the assignee of the present application on Apr. 8, 2019. The disclosure of U.S. patent application Ser. No. 16/378,446 is incorporated by reference herein in its entirety.

[0033] The surgical guides manufactured using the techniques described above may be disposed in a packaging unit. The packaging unit may include a contoured unit having a contoured surface that matches a contour of the biological structure (e.g., bone, such as mandible bone) on which a surgeon would operate. For example, the contoured unit may have contour surfaces of both the donor site (e.g., fibula) and the reconstruction site (e.g., the mandible). The contoured unit may be 3D print of metal, plastic, poly-ether-ether-ketone (PEEK) material, etc. in the same or similar manner as described in U.S. patent application Ser. No. 16/378,446. As such, the surgical guides may be disposed onto the contoured unit and provide a visual aid to the surgeon before the surgery. In some embodiments, the contoured unit also has one or more features that would further facilitate the surgery by providing a visual aid to the surgeon. For example, the contoured unit may have one or more features, such as apertures, which may be holes for receiving surgical screws that are selected based on thickness/depth of bone exhibiting the contour in the 3D model of the desired bone of a patient. Additionally, the contoured unit may be a part of a surgical kit that includes other medical devices (e.g., bone plates) that may be used during the surgery. In some embodiments, the packing unit includes a lid that may have a reverse contour, which is designed to mate with the contour of the surface of the contoured unit in such a way that the contoured unit and the guide(s) and/or other medical devices (e.g., bone plates and surgical screws) are secured in place when the lid is connected to the contoured unit.

[0034] As an example, the surgical unit may include a first guide (e.g., cutting guide) having a contact surface (e.g., second surface 204(b)). In embodiments, the contact surface of the first guide may match a first contoured surface of the surgical kit, which further matches a contour of the biological structure (e.g., fibula) on which a surgeon would operate to carve out the resected bones. The surgical kit may also include a second guide (e.g., template guide) having a contact surface that matches a second contoured surface of the surgical kit, which further matches a contour of the biological structure (e.g., mandible bone or a portion thereof) on which a surgeon would operate.

[0035] Refer now to FIG. 5, which depicts an illustrative method 500 that may be implemented by a surgeon using the surgical guides during a reconstruction procedure. In one embodiment, method 500 begins with block 510 that includes exposing the donor site and securing the cutting guide and the removable inserts to the donor bone by using surgical fastening devices. The method 500 may then move to block 520 that includes resecting one or more portions of the donor bone (e.g., fibula bone is resected using the cutting guide to extract resected fibula bone portions). Once the donor bone is resected, the surgeon may move to block 530 that includes removing removable inserts of the cutting bone, where the removable inserts couple to the respective resected bones. The surgeon may then move to block 540 that includes coupling the removable inserts to a template guide to form a combined structure (such as shown in FIG. 3(b)) including the template guide, the removable inserts, and the resected bones. The combined structure is then transplanted to the reconstruction site (block 550) where the surgeon may fasten (block 560) the resected bones to the left and right zygomatic bones using surgical plates and surgical fastening devices. After securing the resected bones, the surgeon may move to block 570, which may include removing the template guide by sliding it off the removable inserts. Block 570 may then include unscrewing the removable inserts from the resected bones and then removing removable inserts, thereby reconstructing the mandible.

[0036] As noted above, the guides may be patient-specific, and the patient's data may be received by a computer system and stored in a computer-readable medium in the computer system. A method of manufacturing the surgical guide using the patient's data stored in computer-readable medium is now described. The method of manufacturing may include accessing a computer-readable medium having stored thereon one or more three-dimensional (3D) images of a guide and fabricating the guide based on the one or more 3D images. In embodiments, the fabricating the surgical guide may include fabricating the cutting guide 215 having cutting slots (e.g., cutting slots 216-220), removable inserts (e.g., insert 225), and apertures (e.g., 205). In embodiments, the fabricating the guide may further include fabricating the template guide 300 having features designed to mate with the removable inserts of the cutting guide. In embodiments, removable inserts designed to disconnect from the cutting guide upon application of force at a first instance and couple with the template guide upon application of a force at a second instance.

[0037] Although embodiments of the present application and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure of the present invention, processes, machines, manufacture, compositions of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present invention. Accordingly, the appended claims are intended to include within their scope such processes, machines, manufacture, compositions of matter, means, methods, or steps. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification.