• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
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  • 优先权
    • 专利摘要:
    SURGICAL GUIDES FROM SCANNED IMPLANT DATA. The present invention relates to a method for producing a patient-specific surgical guide that includes obtaining a virtual model of an anchoring member, and virtually designing a guide that defines at least one hole that corresponds to a hole of the virtual model of the limb. of fixation.
    公开号:BR112014027419B1
    申请号:R112014027419-3
    申请日:2013-03-11
    公开日:2021-05-18
    发明作者:Andrew Charles Davison；John Wayne Mest
    申请人:Synthes Gmbh；
    IPC主号:
    专利说明:

    Cross Reference
    [0001] This application claims the benefit of Provisional Patent Application Serial No. US 61/645,890 filed May 11, 2012, Provisional Patent Application Serial No. US 61/642,063 filed May 3, 2012 , and also Provisional Patent Application Serial No. US 61/699,938 filed September 12, 2012, the entire descriptions of which are incorporated herein by reference in this application for all purposes. Technical Field
    [0002] The present description generally refers to the apparatus and methods for manufacturing a surgical guide, and more particularly, to the apparatus and methods for manufacturing a patient-specific resection guide. Background of the Invention
    [0003] Many surgical procedures require accurate cuts of the bone. For example, in mandibular reconstruction surgery, the infectious or defective portions of the mandible can be removed from the patient and replaced with bone graft. In some cases, a surgeon performing mandibular reconstruction surgery typically makes multiple cuts to the jaw to properly fit a bone graft. To make an accurate cut, the surgeon can use a resection guide to guide the movement of the resection tool toward the bone. The resection guide can also be used to cut a portion of bone from the patient's other anatomical sites in order to harvest bone grafts.
    [0004] As discussed above, resection guides are typically used to make accurate cuts in the patient's anatomy. Although many resection guides have been developed over the years, it is still desirable to produce resection guides that are specifically designed for a particular patient in order to enhance cutting accuracy. summary
    [0005] The present description relates to methods for producing a patient-specific surgical guide that is configured to guide a movement of a tool towards a tissue body. In one embodiment, the method includes the following steps: (1) obtain a virtual three-dimensional model of a fixation member, the three-dimensional virtual model of the fixation member being obtained having a planned postoperative shape and defining at least one hole that is configured to receive a fastener; (2) processing the virtual three-dimensional model of the fastening member in order to couple the virtual three-dimensional model of the fastening member to a first virtual three-dimensional model of the tissue body, the first virtual three-dimensional model of the tissue body defining a first region, such that a central geometric axis of the at least one hole is substantially aligned with a first target location of the first region; (3) create a virtual three-dimensional model of a guide that defines at least one hole; and (4) processing the virtual three-dimensional model of the guide for the purpose of coupling the virtual three-dimensional model of the guide to a second virtual three-dimensional model of the tissue body having a second region that is substantially identical to the first region, such that an axis The central geometrical pattern of the at least one hole is substantially aligned with a second target location of the second virtual three-dimensional model of the tissue body, wherein the second target location is identically positioned with respect to the first target location with respect to the first and to the second three-dimensional virtual models of the fabric body.
    [0006] In one embodiment, the method includes the following steps: (1) processing a virtual three-dimensional model of an anchor member for the purpose of coupling the virtual three-dimensional model of the anchor member to a first virtual three-dimensional model of the tissue body wherein the first virtual three-dimensional tissue body model defines a first region such that a central geometric axis of the at least one hole is substantially aligned with a first target location of the first region; (2) create a virtual three-dimensional model of a guide that defines at least one hole; and (3) processing the virtual three-dimensional model of the guide in order to couple the virtual three-dimensional model of the guide to a second virtual three-dimensional model of the tissue body having a second region that is substantially identical to the first region, such that an axis The central geometrical pattern of the at least one hole is substantially aligned with a second target location of the second virtual three-dimensional model of the tissue body, wherein the second target location is identically positioned with respect to the first target location with respect to the first and to the second three-dimensional virtual models of the fabric body.
    [0007] In one embodiment, the method includes the following steps: (1) obtain a virtual three-dimensional model of the tissue body; (2) identify in the virtual three-dimensional model of the tissue body a first region and a second region; (3) obtain a virtual three-dimensional model of a fixture member, whereby the obtained virtual three-dimensional model of the fixture member has a planned postoperative shape and defines at least one first hole that is configured to receive a fastener; (4) processing the virtual three-dimensional model of the fastening member in order to couple the virtual three-dimensional model of the fastening member to the virtual three-dimensional model of the tissue body so that a central geometric axis of the at least one first hole is substantially aligned with a first target location from the second region; (5) creating a virtual three-dimensional model of a resection guide that defines at least one pair of cut guides and at least one second hole; and (6) processing the virtual three-dimensional model of the resection guide in order to couple the virtual three-dimensional model of the resection guide to a virtual three-dimensional model of a graft portion disposed between the cutting guides, the graft portion sized to fit in the second region, such that a central geometric axis of the at least one second hole is substantially aligned with a second target location of the three-dimensional model of the graft portion, wherein the second target location substantially coincides with respect to the first target location when the graft portion is positioned in the second region. Brief Description of Drawings
    [0008] The aforementioned summary, as well as the detailed description below of the preferred forms of application, will be better understood when read in conjunction with the attached drawings. For the purpose of illustrating the surgical instruments and methods of the present application, preferred embodiments are shown in the drawings. It should be understood, however, that the application is not limited to the specific embodiments and methods presented, and reference is made to the claims to this end. In the drawings: Figure 1A is a front elevation view of a resection guide coupled to a patient tissue body; Figure 1B is a side elevation view of the resection guide shown in Figure 1A; Figure 1C is a front elevation view of the tissue body shown in Figure 1A after a portion of tissue has been removed from the patient; Figure 1D is a side elevation view of a virtual three-dimensional model of a graft source; Figure 1E is a side elevation view of another resection guide coupled to the graft source; Figure 1F is a perspective view of an attachment member coupled to the tissue body of the patient shown in Figure 1A; Figure 2 is a diagram illustrating the method for producing any of the resection guides shown in Figures 1A, 1B, and 1E, in accordance with an embodiment of the present description; Figure 3A illustrates a physical model of a tissue body in a pre-operative condition and a fixation member applied to the physical model, in accordance with an embodiment of the description; Figure 3B illustrates a virtual three-dimensional model of the physical model and attachment member shown in Figure 3B; Figure 3C illustrates a virtual three-dimensional model of a fixation member resection guide applied to the tissue body in an intra- or postoperative setting; Figure 3D illustrates the virtual three-dimensional model of a resection guide and tissue body, according to an embodiment of the description; Figure 4A is a front elevation view of the clamping member shown in Figure 1F; Figure 4B is a top view of the attachment member and a marker shown in Figure 4A, in accordance with an embodiment of the description; Figures 5A and 5B illustrate a virtual three-dimensional model of the fixation member applied to the tissue body, and a virtual three-dimensional model of a resection guide applied to the graft source, respectively, illustrating how the virtual three-dimensional model of the resection guide includes elements which correspond to the virtual three-dimensional model of the clamping member; Figure 6 is a flowchart describing a method for producing a resection guide in accordance with an embodiment of the present description; Figure 7 is a flowchart describing a method for producing a resection guide in accordance with another embodiment of the present description; and Figure 8 is a flowchart describing a method for producing a resection guide in accordance with another embodiment of the present description. Detailed Description of Illustrative Modalities
    [0009] Certain terminology is used in the following description for convenience only and is not limiting. The words "left", "right", "bottom" and "top" designate directions in the drawings to which reference is made. The words "proximally" and "distally" refer towards and away from, respectively, the surgeon using the surgical device. The words "previous", "posterior", "superior", "inferior" and related words and/or phrases designate the preferred positions and orientations in the human body to which reference is made, and they should not be limiting. The terminology includes the words mentioned above, derivatives of them, and words of similar import.
    [00010] Referring to Figures 1A-1C, a surgical system 8 can include one or more resection guides 100 and 200 that can be coupled to a tissue body 10 to guide one or more tools 101 toward the tissue body 10 in order to prepare the tissue body 10 to receive a graft. For example, the resection guides 100 and 200 may guide a tool 101 that cuts the tissue body 10 for the purpose of creating a void 14 (Figure 1C) in the tissue body 10. The tissue body 10 may define a first and second separate portions 12a and 12b. The first and second tissue portions 12a and 12b may be any particular tissue body portions or segments and are used herein to refer to tissue portions defining the void 14. Additionally, the resection guides 100 and 200 can be used to guide a drill that forms anchorage locations 22 (Figure 1B), eg holes or holes, in the tissue body 10. Anchorage locations are used to allow an anchor or thread to engage a member of fixation of bone, such as plaque, to the tissue body 10 as detailed below. It should be appreciated that the cutting tool 101 can be a saw, blade, drill, or any other tool that has the ability to cut or otherwise prepare tissue. As used herein, tissue body 10 can include a patient bone, such as mandible 12, and can include first and second tissue portions 12a and 12b. The tissue body 10 can also include anatomic tissue, synthetic tissue, or both. Although the drawings illustrate a mandible 12, the tissue body 10 can represent other parts of the patient's anatomy such as a maxilla.
    [00011] Referring to Figure 1A, the resection guide 100 is configured to be coupled to the tissue body 10 and may include a resection guide body 102 that is configured to be in a boundary position with at least a portion of the body of fabric 10, for example the fabric portion 12a. The resection guide body 102 may define an inner surface (not shown) that is contoured to match the contour of a particular outer surface of the tissue body 10 so that the resection guide 100 can only fit over that particular outer surface of the tissue body. fabric body 10. Resection guide 100 may define one or more grooves 104 that are configured and sized to receive cutting tool 101 therein. Slot 104 may extend through resection guide body 102, and may be elongated along a first geometric axis of resection 108. Fabric body 10 may be cut by inserting cutting tool 101 through slot 104 when the resection guide 100 is coupled to the tissue body 10. In particular, the groove 104 guides the movement of the cutting tool 101 towards the tissue body 10 along the first geometric resection axis 108.
    [00012] In addition to the slot 104, the resection guide 100 may additionally include one or more drill holes 106 extending through the resection guide body 102. Each of the drill holes 106 is configured and sized to receive a drill bit or any other suitable tool that has the ability to produce holes in and/or through the fabric body 10. The perforation holes 106 may be elongated along an anchor location geometry axis 20. The anchor location geometry axis anchor 20 then extends through drill hole 106 into alignment with then anchor site 22, e.g., a hole or hole, formed in the tissue body by drill inserted through drill hole 106. 22 is configured and sized to receive an anchor or fastener.
    [00013] The resection guide 100 may further define one or more fastener holes 107 that are configured and sized to receive a fastener such as a pin, wire, or screw therethrough. Each of the fastener holes 107 extends through the resection guide body 102 and is configured to guide movement of the fastener through the resection guide body 102 to temporarily couple the resection guide 100 to the tissue body 10.
    [00014] When the resection guide 100 is coupled to the tissue body 10, the cutting tool 101 can be inserted through the slot 104 and into the tissue body 10 to make a cut in the tissue body 10 at the desired anatomical location . Additionally, the drill can be inserted through the drill holes 106 to form the anchoring sites in the tissue body 10. The fasteners inserted through the fastener holes 107 can then be withdrawn from the tissue body 10 and the resection guide body. 102 to decouple the resection guide 100 from the tissue body 10. While the present description primarily refers to resection guides, any of the resection guides described herein may alternatively be positioning guides, perforation guides, or any other guide that defines at least one hole that is configured to receive a cutting tool such as a drill.
    [00015] Referring to Figure 1B, the resection guide 200 is configured to be coupled to the tissue body 10 to guide the movement of one or more tools 101 towards the tissue body 10 in order to prepare the tissue body 10 The resection guide 200 is configured similarly to the resection guide 100, however, the resection guide 200 can be attached to the tissue body 10 at a location spaced apart from the resection guide 100. The resection guides 100 and 200 can be used to guide a tool 101 to resect tissue from tissue body 10 for the purpose of creating void 14 (Figure 1C). The resection guide 200 may include a resection guide body 202 that is configured to be in a boundary position with at least a portion of the tissue body 10, e.g., tissue portion 12b. The resection guide body 202 may define an inner surface that is contoured to match the contour of a particular outer surface of the tissue body 10 so that the resection guide 200 can only fit over that particular outer surface of the tissue body 10 The resection guide 200 may define one or more grooves 204 that are configured to receive the cutting tool 101. In the embodiments shown, the resection guide 200 may define a first groove 204 and a second groove 205. Each of the first grooves slot 204 and second slot 205 extend through resection guide body 202, and each may be configured to receive cutting tool 101. First slot 204 may be elongated along a first geometric axis of resection 208 of so that the first groove 204 can guide the movement of the cutting tool 101 within the fabric body 10 along the first geometric axis of resection 208. the slot 205 can be elongated along a second resection axis 209 so that the second slot 205 can guide the movement of the cutting tool 101 within the fabric body 10. The first resection axis 208 can be oriented at an oblique angle to the second geometric axis of resection 209. In operation, the cutting tool 101 can be inserted through a slot 204 and 205 and into the fabric body 10 to color the fabric body 10.
    [00016] In addition to the first slot 204 and the second slot 205, the resection guide 200 may define one or more drill holes 206 that extend through the resection guide body 202. Each of the drill holes 206 is configured and sized to receive a drill or any other suitable tool that has the ability to drill holes into and/or through the fabric body 10. Drill holes 206 may be elongated along an anchor location geometric axis 24. Anchor site geometry axis 24 then extends through drill hole 106 in alignment with anchor site 22, e.g., a hole or hole, formed in the tissue body by drill inserted through drill hole 206. Anchoring location 22 is configured and sized to receive an anchor or fastener.
    [00017] The resection guide 200 may additionally define one or more fastener holes 207 that extend through the resection guide body 202 that are configured and sized to receive a fastener, such as a pin, a wire, or a screw, which is used to temporarily couple the resection guide 200 to the tissue body 10. Once the resection guide 200 is coupled to the tissue body 10, the cutting tool 101 can be inserted through the slot 204 and into the body. of tissue 10 to make a cut in tissue body 10 at the desired anatomical location. Additionally, cutting tool 101 can be inserted through slot 205 and into tissue body 10 to make a cut in tissue body 10 at the desired anatomical location. A drill can be inserted through the drill guide holes 206 to form an anchorage location 22 in the tissue body 10. When cuts have been made in the tissue body 10 along the geometric resection axes 108, 208, and 209, a portion of the tissue body 10 can be removed from the patient. Fasteners inserted through fastener holes 207 can be withdrawn from tissue body 10 to decouple resection guide 200 from tissue body 10.
    [00018] Referring to Figure 1C, as discussed above, cuts can be made in tissue body 10 along geometric axes of resection 108, 208, and 209 to allow removal of a portion of tissue from tissue body 10 , thereby defining a void 14 in the fabric body 10. The void 14 extends between the cut, exposed surfaces of the fabric portion 12a and 12b. The portion of tissue removed may be damaged or diseased tissue. The void 14 of tissue body 10 can be filled with the graft, and the graft coupled to tissue portions 12a and 12b with the bone fixation element, or plate, as discussed in detail below.
    [00019] With reference to Figures 1D-E, as discussed above, the removed portion of tissue can be replaced by the graft, such as a 320 graft (Figure 1F). The graft can be harvested from any suitable graft source 300, such as a vascularized bone graft source. Additionally, the graft can be an autologous graft. Examples of suitable graft sources include, without limitation, the scapula, hip, rib, forearm, among others. Graft source 300 can also be a fibula 302. Regardless of the type of graft source selected, graft source 300 can be cut into appropriate orientation locations to obtain a graft that properly fits into the void 14 (Figure 1C) defined by the exposed surfaces by cutting the fabric portions 12a and 12b. To define the size and shape of the desired graft, a virtual three-dimensional model 301 of graft source 300 can be obtained to determine the proper location and orientation of the cuts to be made to harvest a graft from graft source 300. The virtual three-dimensional model 301 of graft source 300 can be obtained by scanning graft source 300 using any suitable technology such as X-ray computed tomography (CT), or any suitable mapping technology, eg laser, optics, CT, formation of magnetic resonance imaging (MRI) and coordinate measuring machines. In one embodiment, an imaging machine, such as a CT machine, can be used to scan graft source 300. The imaging machine can include or be in electronic communication with a computer, such as a computer 530, which includes a computer memory in electronic communication with a processor. Computer 530 can be any computing device and can include a smart phone, tablet, or any other computer. Data obtained by scanning the graft source 300 can be transmitted to or stored in computer memory. The scanned data can be processed, by means of the processor, and in accordance with software instructions running on computer 530, to create virtual three-dimensional model 301 of graft source 300. Alternatively, scanned data can be downloaded or transferred wirelessly or via a wired connection through an electronic communications network to a different computing device at a location that is remote from the imaging machine, in order to create the virtual three-dimensional model 301 of the graft source 300 .
    [00020] When the 301 virtual three-dimensional model of the 300 graft source has been obtained, the surgical operation can be planned. The surgical operation can be planned using any suitable software program that is configured to process, edit and manipulate data that is representative of the scanned graft source image, eg scanned image data. The software operates through a network computing architecture that includes both client and host computing devices. Additionally, the software may be a web-based application configured to process instructions based on input from a graphical user interface running on a computer, eg computer 530. In one embodiment, a suitable software program configured to process, manipulate and or edit images or image data, is sold or licensed under the PROPLAN CMF® trademark by Synthes. PROPLAN CMF® can be used to process and manipulate the virtual three-dimensional model 301.
    [00021] The 320 graft that replaces the removed tissue portion should be configured and sized to properly fit void space 14 (Figure 1C). For example, a plurality of graft portions 304, 306, and 308 can be harvested from graft source 300 and then interconnected from a complete graft for insertion into void 14. As such, resection axes can be defined in order to form a plurality of graft portions 305, 306, and 308. Using the virtual three-dimensional model 301 of graft source 300, the resection can be planned by means of the computer running the software it is configured to process, manipulate and edit images, such as the scanned image data described above. The user can enter instructions that cause the processor to perform the desired edits or manipulations to the 301 virtual three-dimensional model of the Graft Source 300. The user can determine the location and orientation of the resections to be made on the Graft Source 300 to obtain graft portions 304, 306, and 308 that can later be interconnected to form graft 320. To harvest graft portions 304, 306, and 308, the user can determine that the cuts were made along the geometric axes of resection 310, 312, 314, 316, and 318. It should be appreciated that for the patient's anatomy and shape and size of the portion of tissue removed, resections can be made along other geometric axes of resection to form the appropriately sized graft portions.
    [00022] With continuous reference to Figures 1D-E, after planning the desired resections to be performed on the graft source 300 using the virtual three-dimensional model 301 on the computer, the resection guide 400 configured according to the planned surgical procedure and fabrication using rapid production technology as described below can be placed on graft source 300 to guide the movement of cutting tool 101 within graft source 300. Resection guide 400 may include a resection guide body 402 which is configured and adapted to be in a boundary position with at least a portion of the graft source 300. The resection guide body 402 may define an inner surface that can be contoured to match a particular outer surface of the graft source 300 so that the resection guide 400 can only fit over that particular outer surface of the graft source 300.
    [00023] The resection guide 400 defines a plurality of grooves that are each configured to receive the cutting tool 101 to guide the movement of the cutting tool 101 towards the graft source 300. In the embodiment shown, the guide resection 400 may define a first slot 410, a second slot 412, a third slot 416, and a fourth slot 418 that are spaced apart. Each of slots 410, 412, 416, and 418 extends through resection guide body 402. Resection guide 400 can be configured so that slots 410, 412, 416, and 418 are substantially aligned with the axes predetermined resection patterns 310, 312, 314, 316, and 318 when resection guide 400 is placed over graft source 300. For example, first slot 410 may be substantially aligned with first resection axis 310 when Resection guide 400 is placed over graft source 300. Second slot 412 may be substantially aligned with second resection axis 312 when resection guide 400 is placed over graft source 300. Third slot 414 may be substantially aligned with the third axis of resection 314 when the resection guide 400 is placed over the graft source 300. The fourth slot 416 may be substantially aligned with the fourth axis of resection 316 when resection guide 400 is placed over graft source 300. Fifth slot 418 may be substantially aligned with fifth resection axis 318 when resection guide 400 is placed over graft source 300.
    [00024] In addition to the grooves, the resection guide 400 can additionally define one or more drilling holes 406 that are configured and sized to receive at least one drill or any other apparatus that has the ability to produce anchorage sites 303, such as a hole or hole, in graft source 300. In operation, the drill may be inserted through some or all of the drill holes 406 to produce a hole in graft source 300. Anchor sites formed in graft source 300 are configured and sized to receive an anchor such as a screw, rivet, nail or a suitable bone fixation device. Anchoring sites 303 may correspond to openings formed in an anchoring member, such as a plate, so that the anchor can be inserted through anchoring member openings within respective anchoring sites 303 in graft source 300, as discussed bellow.
    [00025] The resection guide 400 may additionally define one or more fastener holes 407 that are configured and sized to receive a fastener, such as a pin, wire, or screw. The fastener can be inserted through the fastener holes 407 and into the graft source 300 to temporarily couple the resection guide 400 to the graft source 300. The resection guide 400 can be attached to the graft source 300 by inserting fasteners through fastener holes 407. Then, cutting tool 101 can be sequentially inserted through slots 410, 412, 416, and 418 and advanced into graft source 300 for the purpose of cutting and harvesting graft portions 304 , 306, and 308. A drill can be inserted into drill holes 406 to form anchorage sites 303 (not shown) in graft source portions 304, 306, and 308. Resection guide 400 can then be decoupled from graft source. graft 300 by removing the fastener from the fastener holes 407 and the graft source 300.
    [00026] Referring to Figure 1F, the graft portions 304, 306, and 308 can then be placed in the void 14 (Figure 1C) in order to replace the tissue portion removed from the tissue body 10. The graft portions 304, 306, and 308 may then be coupled together to form graft 320. Any suitable anchor member 322, such as an anchor plate 324, and a plurality of anchors such as screws can be used to engage the graft portions 304. , 306, and 308 join to form graft 320. Graft 320 may be a bone graft, and may be connected to tissue body 10 using fixation member 322, such as fixation plate 324.
    [00027] In one embodiment, the fixation member 322 can be configured as a bone fixation implant. The fixation member 322 can be flexed so that its contour matches the contour of the tissue body 10 and the interconnected graft portions 304, 306, and 308. For example, the fixation member 322 can be contoured along the length of the graft portion. tissue 12a, graft 320 and tissue portion 12b. Additionally, fastening member 322 defines one or more holes 326 that are configured to receive an anchor as discussed above. Holes 326 can be threaded or partially threaded holes depending on the type of anchor selected. When fixation member 322 is placed against tissue body 10 and graft portions 304, 306, and 308, one or more anchors can be inserted through at least one fastener hole 326 and into anchoring sites 22 in the tissue body 10 or in the anchoring sites 303 formed in the graft 320 for the purpose of coupling the graft portions 304, 306, and 308 together and to couple the graft 320 to the tissue body 10. The fixation member 322 may be formed from a variety of biocompatible materials such as cobalt-chromo-molybdenum (CoCrMo), titanium, and titanium alloys, stainless steel, ceramics, or polymers such as polyether ether ketone (PEEK), poly ether ketone ketone (PEKK) , and bioresorbable materials. A coating can be added or applied to the 410 Bone Fixation Implant to enhance physical or chemical properties or to deliver medications. Examples of coatings include plasma-sprayed titanium or hydroxy apatite coating. According to an alternative embodiment, the fixation member 322 may be a patient-specific bone fixation plate.
    [00028] Referring to Figures 2 and 3A-3D, 5A and 5B, a method for producing a surgical patient-specific resection guide, for example, any of the resection guides 100, 200 and/or 400 in the described description above or any other suitable resection guide. The method may include all or some of the steps schematically represented as steps A, B, C, D, E, and F in Figure 2, some of which are performed using one or more computing devices, or computers 530 that run suitable software used to manipulate or edit images and/or three-dimensional models. In accordance with the embodiment illustrated in Figure 2, the method for producing a patient-specific surgical guide may include in step A obtaining a physical model of a tissue body and an anchoring member, e.g., fixation member 322. B may include scanning the physical model of the tissue body and fixation member using a 508 scanning and/or mapping machine. Step C may include creating a virtual three-dimensional model of the physical model and fixation member on a computer 530. Step D may include creating a virtual three-dimensional model of the fixation member applied to the tissue body in an intra- or postoperative setting. The intra- or post-operative configuration means the desired or intended shape of the tissue body and fixation member when the tissue body 10 has been surgically reconstructed with a fixation member graft. Step E may include creating a virtual three-dimensional model of a resection guide based on the intra- or post-operative virtual three-dimensional model of the tissue body and fixation member. Step F may include producing a surgical resection guide based on the virtual three-dimensional model of the resection guide.
    [00029] Referring to Figures 2 and 3B, in step A the user obtains a physical model 500 of the tissue body 10. The tissue body 10 can be a native tissue body or a reconstructed tissue body. The physical model 500 of tissue body 10 can be created by scanning tissue body 10 using any suitable technology and then forming a three-dimensional model based on the scanned data. For example, a virtual three-dimensional model 510 of tissue body 10 can be obtained by scanning tissue body 10 using any suitable technology, such as CT machine, laser scanning machine, optical scanning machine, machine of MRI, and coordinate measuring machine. In one embodiment, a scanning machine can be used to scan a tissue body 10 for the purpose of obtaining scanned data from the tissue body 10. The scanned data is then downloaded or transferred to a computer in electrical communication with the machine. scanning. For example, the scanned data can be transmitted wirelessly or through a wired connection over a LAN, WAN or any communications network suitable for the computer. On the computer, a virtual three-dimensional model 510 of tissue body 10 is created using a computer running suitable software that has the ability to process and edit, or manipulate images and/or image data. Virtual three-dimensional model 510 of tissue body 10 is a representation of tissue body 10 in its preoperative condition. As further detailed below, the virtual three-dimensional model 510 of the tissue body 10 can be manipulated according to a surgical plan in order to obtain a virtual three-dimensional model 520 (Figure 3C) of the tissue body 10 in its intra- or postoperative configuration. . In other words, virtual three-dimensional model 510 can be manipulated so that the model represents the desired or intended shape and configuration of tissue body 10 when the resected tissue has been replaced by graft 320. Virtual three-dimensional model 520 of tissue body 10 is downloaded or transferred over a communications network to a manufacturing machine or machines. Then, using the virtual three-dimensional model 520 of tissue body 10, the fabrication machine can create a physical model 500 (Figure 3A) of tissue body 10 in its intra- or post-operative condition. For example, a rapid prototyping process or device can be used to create the physical model 500 of tissue body 10 using the virtual three-dimensional model of tissue body 10. In rapid prototyping processes, a virtual design , as a computer-aided design model, is transformed into a physical model. Examples of rapid prototyping processes and devices include, without limitation, selective laser sintering (SLS), fused deposition modeling (FDM), stereolithography (SLA), and 3D printing. A Computer Numerical Control (CNC) machine can also be used to create the physical model 500 of the tissue body 10 in its pre-operative or post-operative condition.
    [00030] Once the user obtains the physical model 500 of the tissue body 10, the fixation member 322, such as a fixation plate 324 or any other bone fixation implant, can be coupled to the physical model 500. In modality shown, fixation plate 324 can flex to conform to the shape of physical model 500. That is, fixation member 322, like fixation plate 324, can be shaped according to a planned postoperative format. Attachment plate 324 can be coupled to physical model 500 in the same location and in the same orientation in physical model 500 as it would be placed in tissue body 10. One or more markers 502 may be inserted at least partially into at least one of holes 326 of fastening member 322 to mark the location and angulation of that fastener hole 326. Each marker 502 may include a handle 504 and a rod 506 extending from the handle 504. At least a portion of the rod 506 may be configured and sized to be received by one of holes 326. The rod may define a length and in some embodiments some markers 502 may have rods 506 with shorter lengths than others. Markers 502 with shorter length rods 506 can be positioned between markers 502 with longer rods 506 to accommodate the maximum number of markers 502 in fastener holes 326.
    [00031] With reference to Figures 4A and 4B, the clamping member 322 may include a clamping member body 321. The clamping member body 321 extends between a first end 321a and a second end 321b opposite the first end 321a along a longitudinal direction L. The fastening body 321 defines an outer surface 323 and an inner surface 325 separated from the outer surface 323 along a transverse direction T that is transverse to the longitudinal direction L. The inner surface 325 is configured to contouring the surface of the graft source or tissue body 10. The fixation member 322 has a thickness defined as the distance between the outer surface 323 and the inner surface 325. The fixation member body 321 defines a plurality of holes 326 that extend through the clamping member body 321 along a central hole geometric axis X. The holes 326 spaced apart along the longitudinal direction L. Ca of hole 326 is configured and sized to receive at least one anchor therethrough. Holes 326 can be threaded or partially threaded. Holes 326 can be configured in any shape or orientation to receive an anchor therein. The central hole geometry axis X can then be angled with respect to the T direction. In one embodiment, the central hole geometry axis X of some or all of the holes 326 can be angularly offset with respect to the direction T. The clamping member 322 is configured to be flexed to conform to the shape of a portion of tissue body 10 or a portion of physical model 500 of tissue body as shown in step A of Figure 3A. Prior to flexing clamping member 322, small screw inserts (not shown) can be placed in holes 326 to help maintain the shape of holes 326 during the flexing process. Furthermore, clamping member 322 is generally not flexed or deformed at positions where holes 326 are located to prevent, or at least minimize, significantly changing the shape of holes 326 during flexion.
    [00032] Markers 502 can be used accurately to create holes 326 in a virtual three-dimensional model of clamping member 322. As discussed above in step A, markers 502 can be inserted through holes 326 after clamping member 322 has been sent to conform to the shape of at least a portion of physical model 500 and coupled to physical model 500. A portion of marker 502, such as a portion of rod 506, can be inserted into one of holes 326 such that rod 506 extends along its axis of center hole X. Therefore, rod 506 can be elongated along the axis of center hole X of one of the holes 326 when at least a portion of the rod 506 is inserted in that hole. specific 326. Accordingly, markers 502 can be inserted into one or more holes 326 to identify the angulation of the respective hole 326.
    [00033] Referring to Figure 2, in step B the physical model 500, the fixation member 322, and the markers 502 can be scanned using any suitable imaging or scanning technology described above to obtain scanned image data for physical model 500, fixture member 322, and markers 502. For example, a scanning machine can be used to scan physical model 500, fixture member 322, and markers 502, and with the use of The scanned image data can be used, by means of a computer 530 to create a virtual three-dimensional model 512 of the physical model 500, the fixation member 322, and the markers 502. According to an alternative embodiment, only the physical model 500 and the fixture member 322 are scanned, and a virtual three-dimensional model is created of the physical model 500 and the fixture member 322 so that the markers 502 are not scanned. In a further embodiment, only the fixation member 322, which has been shaped according to a planned intra- or post-operative configuration, is swept. In particular, fixation member 322 can be flexed into a shape for its planned intra- or post-operative shape and then scanned to obtain scanned image data.
    [00034] Referring to Figures 2 and 3B, in step C, once the three-dimensional image of the fixation member 322 coupled to the physical model 500 is obtained with the scanning machine, the scanned image data is loaded into a computer 530 to create a virtual three-dimensional model 512 of the physical model 500, the fixture member 322, and the markers 502. Alternatively, a virtual three-dimensional model of at least the fixture member 322 can be created with computer 530 without the need for data of scanned image of physical model 500 of fastener member 322. Computer 530 may include a processor and a non-transient computer readable storage medium configured to store data, such as scanned image data, and suitable software. Computer 530 may be local, for example, in the same general area as the scanning machine, or remote and the scanned image data is transferred to computer 530 via a communications network. Therefore, the acquired or stored scanned image data can be manipulated by a user through software running on the computer that is local to the scanning machine and/or surgery site or remote to the scanning machine and/or the site of surgery. For example, scanned image data can be remotely manipulated by the surgeon performing the surgery. The 512 virtual three-dimensional model is typically composed of data in different formats. For example, the 3D model 512 can obtain data in a Standard Mosaic Infusion Language (STL) format. Regardless of data format, virtual three-dimensional model 512 includes data that maps and represents the shape, contour, and size of at least physical model 500 and fixation member 322 as coupled to physical model 500.
    [00035] With continued reference to Figures 2 and 3B, in step C the virtual three-dimensional model 512 may include data representing the position of markers 502 on the fastening members 322 for the purpose of enhancing the accuracy of the orientation of the holes 326 of the member of fixture 322. With the visual representation of markers 502, the user can better determine the orientation of holes 326 of fixture member 322. As discussed above in relation to Figures 4A and 4B, markers 502 can help determine the angulation of hole 326 with respect to the T-transverse of the clamping member 322. Using the sweeping process in step B, the location of the opposite ends 327 of each hole 326 can be obtained. However, the path of each hole 326 from a first end of hole 327 to a second end of hole 329 may not necessarily be obtained by the scanning process described in step B. Therefore, the virtual three-dimensional model 512 can be manipulated to create virtually each of the virtual models of the holes 326 of the clamping member 322. To do this, the center hole geometry axis X can be developed in the virtual model in order to extend through the center of the first hole end 327 and the center of the second end of hole 329. Then, hole 326 is created such that it has a path along the central geometric axis X' drawn earlier from that particular hole 326. This process does not involve the use of markers 502. Alternatively, the representation Visual markers 502 can be used to get a more accurate path to holes 326. To do this, the g-axis Center geometry X' is drawn from the second end of hole 329 to one end 507 of rod 506 that is attached to cable 504. Then, hole 326 that follows the center geometry axis X is created in the virtual three-dimensional model 512. can be repeated for each hole 326.
    [00036] In step C, the virtual three-dimensional model 512 can include models of each component. That is, the virtual three-dimensional model 512 may include a virtual three-dimensional model 514 of the physical model 500, a virtual three-dimensional model 516 of the clamping member 322, such as the clamping plate 324, and a virtual three-dimensional model 518 of the markers 502. The models Virtual three-dimensional 512 (or any virtual model described herein) can be manipulated by a user with the use of conventional software typical in the art. For example, a software program that is configured to process and edit images, sold under the PROPLAN CMF® trademark by Synthes, can be used to process and manipulate the virtual templates obtained from the 508 scanning machine. the user reviews the tissue body 10 and preoperatively plan the patient's surgery including the shape and design of a resection guide, such as a resection guide 600 discussed below.
    [00037] Referring to Figures 2 and 3C, in step D, the virtual three-dimensional model 520 of the tissue body 10 can be manipulated in the intra- or postoperative format and configuration according to a planned surgical procedure. Specifically, the virtual three-dimensional model 516 of the fastening member 322 can be imported into a previously obtained three-dimensional model 520 of the tissue body 10, and manipulated using a computer to create a virtual three-dimensional model 520 of the tissue body 10 in the format. and intra- or post-operative format configuration. In other words, through the use of the 520 virtual three-dimensional model of the tissue body 10, the user can pre-plan surgery, such as mandibular reconstruction surgery, on the computer 530 using appropriate software such as the software sold under the trademark PROPLAN CMF® by Synthes. At computer 530, virtual three-dimensional model 516 of fixation member 322 can be coupled to virtual three-dimensional model 520 of tissue body 10 in intra- or postoperative configuration according to a predetermined surgical plan as discussed in detail above in relation to the Figure 1F. Therefore, the virtual three-dimensional model 516 of the fixation member 322 can be aligned with the virtual three-dimensional model 520 of the tissue body 10 in accordance with a desired surgical plane. As discussed above, three-dimensional model 520 may represent a native tissue body 10 or a reconstructed tissue body 10 that includes graft 320. Virtual three-dimensional model 516 of anchor member 322 coupled to three-dimensional model 520 of tissue body 10 is collectively termed the virtual three-dimensional model 526.
    [00038] Referring to Figure 2 and 3D, in step E, a virtual three-dimensional model 522 of a resection guide 600 can be created and designed based on the virtual three-dimensional model 526 of the fixation member 322 coupled to the tissue body 10 Therefore, the resection guide 600 (or any other suitable resection guide) can be designed and manufactured based on the virtual three-dimensional model 526 of the fixation member 322 coupled to the virtual model 520 of the tissue body 10. According to an embodiment Alternatively, the virtual three-dimensional model 522 of the resection guide 600 can be created using a virtual three-dimensional model 521 of the tissue body 10 that was previously obtained by means of a scanning machine. The virtual three-dimensional model 521 of the tissue body 10 may be substantially identical to the virtual three-dimensional model 520 of the tissue body 10 used in step D. However, in some embodiments, the virtual three-dimensional model 521 of the tissue body 10 represents the tissue body 10 in a pre-operative shape or condition.
    [00039] With continued reference to Figure 2 and 3D, in step E, a virtual three-dimensional model 522 of the resection guide 600 can be configured or designed to allow a surgeon to guide the movement of the cutting tool 101 towards the tissue body. 10, for example, when the resection guide is formed as detailed below. In the illustrated embodiment, the resection guide 600, or resection guide template, may include a resection guide body 602 that is configured to be in a boundary position with at least a portion of the tissue body 10. The guide body The resection guide 602 may define at least one groove 604 extending through the resection guide body 602. The groove 604 may be configured and sized to receive the cutting tool 101, and guide the cutting tool 101 toward the fabric body. 10 when resection guide 600 is coupled to tissue body 10, as depicted in a three-dimensional virtual model. In addition to slot 604, resection guide 600 can define one or more drill holes 606 that are each configured and sized to receive a drill or any other apparatus that has the ability to produce holes or anchorage sites in the tissue body. 10. Each of the drill holes 606 can extend through the resection guide body 602. In addition to the drill holes 606, the resection guide 600 can define one or more fastener holes 607 that are each configured and sized to receive a fastener such as a screw. Each of the fastener holes 607 can extend through the resection guide body 602. At least one fastener can be inserted through each fastener hole 607 and into the tissue body 10 to couple the resection guide 600 to the body. of fabric 10.
    [00040] With continuous reference to Figure 2 and 3D, in step E, the virtual three-dimensional model 522 of the resection guide 600 can be designed so that the location and orientation of the drill holes 606 in the virtual three-dimensional model 522 in relation to the fabric body 10 are substantially aligned with the location and orientation of the same number of holes 326 as the fastener member 322. For example, as shown in Figure 3C, in step C, the fastener member 322 includes a first hole 326 and a second hole 326b positioned at a location and orientation G and H, respectively, relative to the tissue body 10. Consequently, the virtual three-dimensional model 522 of the resection guide 600 can be designed, for example, on the computer 530, so that by at least one hole 606a and a second hole 606b have substantially the same location and orientation with respect to the fabric body 10 as one of the holes 326, e.g., holes 326a and 326b, of the fastening member 3 22, with respect to the location and orientation G and H in the tissue body 10. The location G may be referred to as the first position relative to the virtual three-dimensional model 520, and the location identified as H may be referred to as the second position relative to to the virtual three-dimensional model 520. Holes 326a and 326b are located and oriented relative to tissue body 10 such that insertion of anchors through holes 326a and 326b at anchor locations does not impact tissue body nerves 10. Furthermore, holes 326 are located and oriented relative to tissue body 10 so that anchors are inserted through tissue that is undamaged or diseased.
    [00041] Referring to Figure 2, in step F, once the virtual three-dimensional model 522 of the resection guide 600 has been completed, the resection guide 600 can be produced based on the virtual three-dimensional model 522 using any appropriate technology, such as rapid prototyping technology. For example, the virtual three-dimensional model 522 of resection guide 600 can be downloaded or transferred from computer 530 to a machine such as a CAD/CAM manufacturing machine, or to a computer coupled to that machine. The resection guide 600 can be produced using a rapid prototyping process or device. In the rapid prototyping process, a virtual design, such as a computer-aided design model, is transformed into a physical model or construct. Examples of rapid prototyping technologies include, but are not limited to, selective laser sintering (SLS), fused deposition modeling (FDM), stereolithography (SLA), and 3D printing, as well as a numerical control machine of computer (CNC). The fabrication machine 532 produces the resection guide 600 from any desired material. For example, the resection guide 600 can be manufactured partially or entirely from a suitable polymer or metallic material. The user can then perform any desired surgical operation on a patient using the 600 resection guide. All or some of the steps shown in Figure 2A can be performed by a processor or a computer. In addition, all or some of the data involved in the method described above, such as virtual templates, can be stored on computer-readable storage medium that is not transient to a local computer or a remote computer.
    [00042] In addition to the 600 resection guide, the method described above can be used to produce any suitable resection guide. For example, resection guides 100 and 200 can be produced using the method described above. It should be appreciated that all virtual three-dimensional models mentioned in the present description can be created and manipulated with the use of computer aided software that runs on computer 530. The method described in the present application can be used to manufacture resection guides for use in mandibular reconstruction surgery as described above. However, the method described in this application can be used to produce resection guides for use in orthognathic surgery or craniomaxillofacial surgery that may include distraction of bone segments.
    [00043] Referring to Figures 5A and 5B, the method described above can also be used to construct the resection guide 400 used to harvest the graft. In this method, the resection guide 400 may include one or more slots 403 and a plurality of perforation holes 406a-406f. Resection guide 400 can be virtually designed so that the location and orientation of drill holes 406a-f with respect to graft 320 are in substantial alignment with fastener holes 326a-f and tissue locations Y when graft 320 is positioned in void 14 (Figure 1C) and fixation member 322 is positioned against graft 320 and tissue body 10. For example, virtual three-dimensional model 512 of tissue body 10 is obtained as described above with respect to steps AC discussed above and shown in Figures 2, 3A and 3B. Then, in a virtual three-dimensional model of tissue body 10, a first resection region 11 (Figure 1A) and a second resection region 13 (Figure 1A) are identified. The first resection region 11 is also referred to as the first region 11, and the second resection region 13 is also referred to as the second region 13. The virtual three-dimensional model 516 of the fixation member 322 is obtained as described above in relation to Figure 2. The obtained three-dimensional model 516 can have a planned post-operative shape, and can define at least one first hole 326 that is configured to receive a fastener. The virtual three-dimensional model 516 of the clamping member 322 is processed (in a processor) for the purpose of obtaining the virtual three-dimensional model 516 of the clamping member 322 such that a central geometric axis of the at least one first hole 326a is substantially aligned with a first target site K in the second tissue portion 12a of the tissue body. The virtual three-dimensional model 401 of the resection guide 400 is created by, for example, scanning the resection guide 400 as described above in steps B and C of Figure 2. The virtual three-dimensional model 401 of the resection guide 400 can be processed (in a processor) in order to couple the virtual three-dimensional model 401 of the resection guide 400 to the virtual three-dimensional model 301 of the graft portion disposed between at least two cutting guides 403. The graft portion may be the graft portion 304, a graft portion 306, graft portion 308, or a combination thereof. Therefore, the graft portion can be graft 320. The graft portion, such as graft 320, can be sized to fit into second region 13 or void 14. Virtual three-dimensional model 401 of resection guide 400 can be processed by by means of a processor in a computer for the purpose of coupling the virtual three-dimensional model 401 of the resection guide 400 to the virtual three-dimensional model 301 of the graft portion, so that the central geometric axis of one of the perforation holes 406 is substantially aligned with one of the L target sites of the graft source. At least one of target sites L substantially coincides with target site K when graft 320 is positioned in void 14.
    [00044] Referring to Figure 6, a method 700 for producing a resection guide may include steps 701, 702, 703 and 704. Step 701 includes obtaining a virtual three-dimensional model 516 of an attachment member 322, wherein the The obtained virtual three-dimensional model 516 of fixation member 322 has a planned postoperative shape and defines at least one hole 326 that is configured to receive a fastener. Step 702 includes processing the virtual three-dimensional model of the fastener member 322 for the purpose of coupling the virtual three-dimensional model 516 of the fastener member 322 to a first virtual three-dimensional model 520 of the tissue body 10, the first virtual three-dimensional model 520 of the fabric body 10 defines a first region 11 such that a central geometric axis X of the at least one hole 326 is substantially aligned with a first target location M of the first region 11. The first region 11 may correspond to the fabric portion. 12b. Step 703 includes creating a virtual three-dimensional model 522 of a resection guide 600 that defines at least one cut guide 603 and at least one hole 606. Alternatively, step 703 includes creating a virtual three-dimensional model 522 of a guide 600, such as a positioning guide or a perforation guide, which defines at least one hole 606. Step 704 includes processing the virtual three-dimensional model 522 of the resection guide 600 for the purpose of coupling the virtual three-dimensional model 522 of the resection guide 600 with a second virtual three-dimensional model 521 of tissue body 10 having a second region 13 that is substantially identical to the first region 11 such that a central geometric axis of the at least one hole 606 is substantially aligned with a second target location N of the second virtual three-dimensional model 521 of tissue body 10, in which the second target location N is identically positioned with respect to the first target location M with respect to the first. ro and to the second virtual three-dimensional models 520, 521 of the fabric body 10.
    [00045] The second processing step 704 may further include aligning the cutting guide 603 with a preoperatively planned interface between a first region 11 and a second region 13 of the tissue body 10. The obtaining step 701 may additionally include scanning the clamping member 322 to obtain an image of the clamping member 322, transfer via communication network, the image data to a computer, and manipulate the image of the clamping member 322 to define the at least one hole 326 of the clamping member. fastening 322 to virtual three-dimensional model 516 of fastening member 322. The manipulation step includes identifying the central geometric axis X of at least one hole 326. The method may further include constructing resection guide 600 identical to virtual three-dimensional model 522 of guide 600 resection using a rapid prototyping process. The step of constructing resection guide 600 may include transferring the virtual three-dimensional model 522 of resection guide 600 from the computer to a manufacturing machine 532.
    [00046] The obtaining step 701 may include scanning the fixture member 322 using a scanning machine 508. The obtaining step 701 may include scanning the fixture member 322 using any of the following scanning machines , namely: computed tomography machine, laser scanning device, optical scanning device, MRI machine, or coordinate measuring machine. Obtaining step 701 may additionally include coupling fixation member 322 to a physical model 500 of tissue body 10. Obtaining step 701 may further include flexing the fixation member into postoperative shape. The obtaining step 701 may further include inserting at least a portion of a marker 502 into the at least one hole 326 of the fastening member 322 to identify a path of the at least one hole 326 relative to a thickness of the fastening member 322. The obtaining step 701 may additionally include scanning the physical template 500 of the tissue body 10, the marker 502 that is inserted into at least one hole 326 of the fastening member 322, and the fastening member 322 that is coupled to the 500 physical model of tissue body 10.
    [00047] Processing step 704 may include manipulating by means of a processor, in accordance with software stored on a computer-readable medium, the virtual three-dimensional model 522 of resection guide 600 such that resection guide 600 is contoured to fit over a particular portion of the second virtual three-dimensional model 521 of tissue body 10. All or some of the steps shown in Figure 6 or described above can be performed by a processor running on a computer. The virtual three-dimensional models described in this description may be stored on a non-transient computer readable storage medium. The processor and computer-readable storage medium can be part of the same computer or different computers.
    [00048] Referring to Figure 6, a method 800 for producing a surgical patient-specific resection guide 600 may include steps 801, 802, and 803. Step 802 includes processing a virtual three-dimensional model 516 of a fixation member 322 for the purpose of coupling the virtual three-dimensional model 516 of the fastening member 322 to a first virtual three-dimensional model 520 of the tissue body 10, the first virtual three-dimensional model 520 of the tissue body 10 defining a first region 11, such that a central geometric axis X of the at least one hole 326 is substantially aligned with a first target location M of the first region 11. Step 802 includes creating a virtual three-dimensional model 522 of a resection guide 600 that defines at least one cut guide 603 and at least one hole 606. Alternatively, step 802 includes creating a virtual three-dimensional model 522 of a guide, such as a positioning guide or a drill guide, that defines at least one hole 606. Step 803 includes processing the virtual three-dimensional model 522 of the resection guide 600 for the purpose of coupling the virtual three-dimensional model 522 of the resection guide 600 to a second virtual three-dimensional model 521 of the tissue body 10 having a second region 13 that is substantially identical to the first region 11, such that a central geometric axis X of the at least one hole 326 is substantially aligned with a second target location N of the second virtual three-dimensional model 521 of the tissue body 10, at that the second target location N is identically positioned with respect to the first target location M with respect to the first and second virtual three-dimensional models 520, 521 of tissue body 10.
    [00049] According to an alternative embodiment, method 800 illustrated in Figure 6 may additionally include the step of obtaining the virtual three-dimensional model 516 of the clamping member 322 by computer 530. The step of obtaining may include scanning the clamping member 322 with the use of a scanning machine 508. The obtaining step may additionally include scanning the fixation member 322 with the use of any of the scanning machines, namely, computerized tomography machine, laser scanning device, scanning device. optical scanning, MRI machine, or coordinate measuring machine. The method illustrated in Figure 4 may additionally include constructing the resection guide 600 identical to the virtual three-dimensional model 522 of the resection guide 600 using a rapid prototyping process. The construction step may further include transferring the virtual three-dimensional model 522 of resection guide 600 from computer 530 to a fabrication machine 532 via a communications network. The obtaining step may include coupling the fixation member to a physical model of the tissue body. The procurement step may include flexing the fixation member into the post-operative shape. The step of obtaining may include inserting a marker into the at least one hole of the fixture member to identify a path of the at least one hole relative to a thickness of the fixture member. The obtaining step may include scanning the physical model of the tissue body, the marker that is inserted into at least one hole of the fastening member, and the fastening member that is coupled to the physical model of the tissue body. The obtaining step may include scanning the physical model of the tissue body and the fastening member that is coupled to the physical model of the tissue body. Processing step 803 may include manipulating the virtual three-dimensional model of the resection guide such that the resection guide is contoured to fit over a particular portion of the second virtual three-dimensional model of the tissue body. All or some of the steps shown in Figure 7 or described above can be performed by a processor such as a computer.
    [00050] Referring to Figure 8, a method 900 for producing a surgical patient-specific resection guide 600 may include steps 901, 902, 903, 904, 905, and 906. Step 901 includes obtaining a virtual three-dimensional model 521 of tissue body 10. Step 902 includes identifying in the virtual three-dimensional model 522 of tissue body 10 a first retention region 11 and a second resection region 13. The first resection region 11 is also referred to as the first region 11, and the second resection region 13 is also referred to as the second region 13. Step 903 includes obtaining a virtual three-dimensional model 516 of an anchor member 322, the obtained virtual three-dimensional model 516 of the anchor member 322 being post-shaped. -planned operative and define at least one first hole 326 that is configured to receive a fastener. Step 904 includes processing the virtual three-dimensional model 516 of the fastening member 322 for the purpose of coupling the virtual three-dimensional model 516 of the fastening member 322 to the virtual three-dimensional model of the tissue body 10 such that a central geometric axis X of the fur unless a first hole 326 is substantially aligned with a first target location K of the second resection region 13. Step 905 includes creating a virtual three-dimensional model 401 of a resection guide 400 defining at least one pair of cutting guides 403 and at least one second hole 406. Step 906 includes processing the virtual three-dimensional model 401 of the resection guide 400 for the purpose of coupling the virtual three-dimensional model 401 of the resection guide 400 to a virtual three-dimensional model 301 of a graft portion 320 disposed between the cutting guides 403, the graft portion 320 sized to fit the second region 13 so that a central geometric axis of the at least one second hole 406 is substantially aligned with a second target site L of the three-dimensional model 301 of graft portion 320, wherein second target site L substantially coincides with respect to first target site K when graft portion 320 is positioned in the second resection region 13. All or some of the steps shown in Figure 5 or described above can be performed by one processor. Obtaining step 901 may include scanning the clamping member to obtain an image of the clamping member, and manipulating the clamping member image to define the at least one first clamping member hole in the virtual three-dimensional model of the clamping member. The manipulation step may further include identifying the central geometric axis of the at least first hole. The method may further comprise the step of building the resection guide identical to the virtual three-dimensional model of the resection guide using a rapid prototyping process.
    [00051] It should be noted that the illustrations and discussions of the modalities shown in the figures are for illustrative purposes only, and should not be considered as limiting the description. The person skilled in the art will appreciate that the present description contemplates several modalities. For example, although the present description refers to three-dimensional virtual models, it is envisioned that any of the virtual models in the present description may be two-dimensional. It is to be further understood that features and structures described and illustrated in accordance with an embodiment may apply to all embodiments as described herein, except where otherwise indicated. Additionally, it should be understood that the concepts described above with the above-described embodiments may be employed alone or in combination with any of the other embodiments described above.
    权利要求:
    Claims (15)
    [0001]
    1. A method of producing a patient-specific surgical guide (600) that is configured to guide a movement of a tool toward the tissue body (10), the method comprising the steps of: processing a virtual three-dimensional model (516) of a fastening member (322) for the purpose of coupling the virtual three-dimensional model (516) of the fastening member (322) to a first virtual three-dimensional model (520) of the tissue body (10), the first virtual three-dimensional model being (520) of the fabric body defines a first region (11) such that a central geometric axis (X) of at least one hole (326) of the virtual three-dimensional model (516) of an anchor member (322) configured to receiving a fastener is aligned with a first target location (M) of the first region (11); creating a virtual three-dimensional model (522) of a guide (600) that defines at least one hole (606); and characterized in that it processes the virtual three-dimensional model (522) of the guide (600) in order to couple the virtual three-dimensional model (522) of the guide (600) to a second virtual three-dimensional model (521) of the tissue body (10 ) which has a second region (15) that is identical to the first region (11), so that a central geometric axis of the at least one hole (606) of the virtual three-dimensional model (522) of the guide (600) is aligned with a second target location (N) of the second virtual three-dimensional model (522) of the tissue body (10), wherein the second target location (N) is identically positioned with respect to the first target location (M) with respect to the first and second virtual three-dimensional models (521, 522) of the fabric body (10).
    [0002]
    2. Method according to claim 1, characterized in that it further comprises obtaining the virtual three-dimensional model (516) of the fixation member (322) in a computer (530).
    [0003]
    3. Method according to claim 2, characterized in that the step of obtaining the virtual three-dimensional model (516) of the fixture member (322) includes coupling the fixture member (322) to the physical model (500) of the tissue body (10) and the step of obtaining the virtual three-dimensional model (516) of the fixation member (322) further includes scanning the physical model (500) of the tissue body (10), and the fixation member (322) which is coupled to the physical model (500) of the tissue body (10).
    [0004]
    4. Method according to claim 1, characterized in that it comprises the step of obtaining a virtual three-dimensional model (516) of a fastening member (322), the virtual three-dimensional model (516) obtained from the fastening member ( 322) having a planned post-operative shape and defining at least one orifice (316) that is configured to receive a fastener.
    [0005]
    5. Method according to claim 4, characterized in that the step of creating includes creating a virtual three-dimensional model (516) of the guide (600) that defines at least one cutting guide.
    [0006]
    6. Method according to claim 5, characterized in that the second processing step further comprises aligning the cutting guide with a pre-operative planned interface between the second region (11) and a resection region (13) of the tissue body (10).
    [0007]
    7. Method according to any one of claims 1 to 6, characterized in that the step of obtaining the virtual three-dimensional model (516) of the clamping member (322) includes scanning the clamping member (322) using a machine of scanning.
    [0008]
    8. Method according to any one of claims 1 to 7, characterized in that the step of obtaining the virtual three-dimensional model (516) of the clamping member (322) includes scanning the clamping member (322) using a machine scanner selected from the group consisting of computed tomography machine, laser scanner, optical scanner, magnetic resonance machine, and coordinate measuring machine.
    [0009]
    9. Method according to any one of claims 1 to 8, characterized in that the step of obtaining the virtual three-dimensional model (516) of the clamping member (322) includes coupling the clamping member (322) to a model fabric body (500) body (10), wherein the step of obtaining the virtual three-dimensional model (516) of the fixture member (322) further includes bending the fixture member (322) to a post-operative shape.
    [0010]
    10. Method according to claim 9, characterized in that the step of obtaining the virtual three-dimensional model (516) of the fastening member (322) further includes inserting a marker (502) into the at least one hole (326 ) of the fastening member (322) to identify a path of the at least one hole (326) with respect to a thickness of the fastening member (322).
    [0011]
    11. Method according to claim 9 or 10, characterized in that the step of obtaining the virtual three-dimensional model (516) of the fixation member (322) further includes scanning the physical model (500) of the tissue body ( 10), the marker (502) that is inserted into at least one hole (326) of the fastening member (322), and the fastening member (322) that is coupled to the physical template (500) of the tissue body ( 10).
    [0012]
    12. Method according to any one of claims 1 to 11, characterized in that the step of processing the virtual three-dimensional model (516) of the guide (600) includes manipulating the virtual three-dimensional model (516) of the guide (600) so that the guide (600) is contoured to fit over a specific portion of the second virtual three-dimensional model (521) of the tissue body (10).
    [0013]
    13. A method of producing a patient-specific surgical guide (400) that is configured to guide a movement of a cutting tool toward the tissue body, the method comprising: obtaining a virtual three-dimensional model (522) of the tissue body ( 10); identify in the virtual three-dimensional model (522) of the tissue body (10) a first region (11) and a second region (13); obtain a virtual three-dimensional model (516) of a fixture member (322), the three-dimensional virtual model (516) obtained of the fixture member (322) having a post-operative planned shape and defining at least a first hole (326) that is configured to receive a fixer; processing the virtual three-dimensional model (516) of the fixation member (322) so as to couple the virtual three-dimensional model (516) of the fixation member (322) to the virtual three-dimensional model (516) of the tissue body (10), so that a central axis (X) of the at least one first hole (326) is aligned with a first target location (K) of the second region (13); creating a virtual three-dimensional model (401) of a resection guide (400) defining at least one pair of cut guides (403) and at least one second hole (406); and characterized in that it processes the virtual three-dimensional model (401) of the resection guide (400) so as to couple the virtual three-dimensional model (401) of the resection guide (400) to a virtual three-dimensional model (301) of a portion of the graft (320) disposed between the cutting guides (403), the graft portion (320) sized to fit the second region (13) so that a central axis of the at least one second hole (406) is aligned with a second target location (L) of the three-dimensional model (301) of the graft portion (320), wherein the second target location (L) coincides with the first target location (K) when the graft portion (320) is positioned in the second region (13).
    [0014]
    14. Method according to any one of claims 4 to 13, characterized in that the step of obtaining further comprises scanning the fixation member (322) to obtain an image of the fixation member (322), and manipulating the image of the fastening member (322) to define the at least one hole (326) of the fastening member (322) in the virtual three-dimensional model (516) of the fastening member (322), wherein the manipulation step comprises identifying the central axis (X) of at least one orifice (326).
    [0015]
    15. Method according to any one of claims 1 to 14, characterized in that it further comprises constructing the guide (600, 400) identical to the virtual three-dimensional model (522, 401) of the guide (600, 400) using a process rapid prototyping fabrication, wherein the step of building the guide (600, 400) includes transferring the virtual three-dimensional model (522, 401) of the guide from a computer to a manufacturing machine.
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    KR102180559B1|2018-09-28|2020-11-18|연세대학교 산학협력단|Customized Surgical Guide for Mandibular Chin, Manufacturing Method Thereof, Recording Medium Therefor, Manufacturing Apparatus Therefor|
    KR102040454B1|2018-12-05|2019-11-06|메디쎄이|Customized implant using 3D printing|
    CN109758208B|2019-03-04|2020-12-08|美创医核公司|Bone cutting guide plate and preparation method thereof|
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    法律状态:
    2018-03-27| B15K| Others concerning applications: alteration of classification|Ipc: A61B 17/15 (2006.01), A61B 17/17 (2006.01) |
    2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-12-17| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-04-20| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-05-18| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 11/03/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201261642063P| true| 2012-05-03|2012-05-03|
    US61/642,063|2012-05-03|
    US201261645890P| true| 2012-05-11|2012-05-11|
    US61/645,890|2012-05-11|
    US201261699938P| true| 2012-09-12|2012-09-12|
    US61/699,938|2012-09-12|
    PCT/US2013/030131|WO2013165558A1|2012-05-03|2013-03-11|Surgical guides from scanned implant data|
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