SYSTEMS FOR ESTABLISHING AN INTRAMEDULAR PATH

专利摘要:
systems for establishing an intramedullary path the present invention relates to a system for establishing an intramedullary path includes a body (200) dimensioned and configured to be received within a resected bone space. the body defines a first opening (206) which extends through the body and is sized and configured to receive a surgical instrument through it. a first bone engaging structure (222) extends from the body in a first direction and includes a first surface (228) which is complementary to the topography of the surface of a first bone (16). when the first surface of the bone engaging structure engages the topography of the surface of the first bone to which the first surface is complementary, an axis defined by the first opening is substantially collinear with a mechanical axis of the first bone.
公开号:BR112013015526B1
申请号:R112013015526-4
申请日:2011-12-20
公开日:2021-03-23
发明作者:Paul Stemniski；Richard Obert；Sarah LANCIANESE
申请人:Wright Medical Technology, Inc.；
IPC主号:

专利说明:

[0001] The present invention claims the priority of United States Patent Application US 13 / 330,091 filed on December 19, 2011, Provisional Patent Application in United States US 61 / 425,054 filed on December 20, 2010 and Patent Application in United States United States 61 / 482,657 filed on May 5, 2011, the complete content of which is incorporated by reference into the present invention. FIELD OF THE INVENTION
[0002] The present invention relates to a system and method generally related to surgical guides. More specifically, the system and method described in the present invention refer to surgical guides for orthopedic procedures involving the ankle. BACKGROUND OF THE INVENTION
[0003] Prostheses for photal joint replacement usually include a mold or fixation device to enable a surgeon to make precise and accurate bone resections around and in the joint being prepared to receive the prosthesis. The ultimate goal of any total joint prosthesis is to approximate the function and structure of the healthy natural structures that the prosthesis is replacing. If the prosthesis is not properly fixed to the joint, that is, ankle or knee, misalignment can result in discomfort for the patient, gait problems or degradation of the prosthesis.
[0004] Many surgical procedures use fluoroscopy to check the alignment of the intramedullary cavities that are prepared to receive the joint replacement prosthesis. However, the use of intraoperative fluoroscopy in the operating room has several disadvantages. A disadvantage is that the use of fluoroscopy to check the alignment of intramedullary cavities formed during surgery increases the total duration of the surgical procedure because it takes time to obtain and evaluate fluoroscopic images. Long surgeries lead to a longer time for the use of the tourniquet by the patient and, therefore, can increase the recovery time.
[0005] Another disadvantage of fluoroscopy is that it exposes the patient and others in the operating room to ionized radiation. For example, the US Food and Drug Administration ("FDA") has several articles and public health reports related to the use of fluoroscopy during surgical procedures. Consequently, although measures are taken to protect the patient and others from ionized radiation, it is practically impossible to eliminate all the risk associated with ionized radiation. BRIEF DESCRIPTION OF THE INVENTION
[0006] - um corpo dimensionado e configurado para ser recebido dentro de um espaço ósseo ressecado e definindo uma primeira abertura que se estende através do corpo e é dimensionada e configurada para receber um instrumento cirúrgico através da mesma; e - uma primeira estrutura de engate ósseo se estende a partir do corpo em uma primeira direção e inclui uma primeira superfície que é complementar à topografia de superfície de um primeiro osso, - no qual quando a primeira superfície da estrutura de engate ósseo engata a topografia da superfície do primeiro osso ao qual a primeira superfície é complementar, um eixo definido pela primeira abertura é substancialmente colinear a um eixo mecânico do primeiro osso. A presente invenção também descreve um sistema para estabelecer um trajeto intramedular que compreende: - um suporte para guia de broca incluindo um corpo dimensionado e configurado para ser recebido dentro de um espaço ósseo ressecado, o corpo definindo uma primeira abertura que se estende afravés do corpo, uma primeira estrutura de engate ósseo que se estende a partir do corpo em uma primeira direção e incluindo uma primeira superfície que é complementar à topografia da superfície do primeiro osso: e - um guia de broca dimensionado e configurado para ser recebido dentro da primeira abertura definida pelo corpo do suporte para guia de broca, o guia de broca definindo uma segunda abertura dimensionada e configurada para receber o instrumento cirúrgico através da mesma, - no qual quando a primeira superfície da estrutura de engate ósseo engata a topografia da superfície do primeiro osso ao qual a primeira superfície é complementar, um eixo definido pela segunda abertura é substancialmente colinear a um eixo mecânico do primeiro osso. A presente invenção ainda descreve um método que compreende: - inserir um guia de broca em uma abertura definida por um suporte para guia de broca, o suporte para guia de broca incluindo uma primeira estrutura de engate ósseo que se estende a partir de um corpo do suporte para guia de broca em uma primeira direção e possuindo uma primeira superfície que é complementar à topografia da superfície de um primeiro osso; - inserir o suporte para guia de broca e o guia de broca disposto dentro da primeira abertura do suporte para guia de broca em um espaço ósseo ressecado, de modo que a primeira superfície da estrutura de engate ósseo engata o primeiro osso de maneira correspondente; e - passar um instrumento cirúrgico através de uma segunda abertura definida pelo guia de broca para estabelecer um canal intramedular dentro do primeiro osso que é substancialmente colínear a um eixo mecânico do primeiro osso. The present invention describes a system for establishing an intramedullary path that comprises: - a body dimensioned and configured to be received within a resected bone space and defining a first opening that extends through the body and is dimensioned and configured to receive a surgical instrument through it; and - a first bone hitch structure extends from the body in a first direction and includes a first surface that is complementary to the surface topography of a first bone, - in which when the first surface of the bone engaging structure engages the topography of the surface of the first bone to which the first surface is complementary, an axis defined by the first opening is substantially collinear with a mechanical axis of the first bone. The present invention also describes a system for establishing an intramedullary path that comprises: - a drill guide support including a body dimensioned and configured to be received within a resected bone space, the body defining a first opening that extends through the body, a first bone engagement structure that extends from the body in a first direction and including a first surface that is complementary to the topography of the surface of the first bone: and - a drill guide sized and configured to be received within the first opening defined by the body of the drill guide holder, the drill guide defining a second opening dimensioned and configured to receive the surgical instrument through it, - in which when the first surface of the bone engaging structure engages the topography of the surface of the first bone to which the first surface is complementary, an axis defined by the second opening is substantially collinear with a mechanical axis of the first bone. The present invention further describes a method which comprises: - insert a drill guide into an opening defined by a drill guide holder, the drill guide holder including a first bone engaging structure that extends from a body of the drill guide holder in a first direction, and having a first surface that is complementary to the topography of the surface of a first bone; - insert the drill guide support and the drill guide arranged inside the first opening of the drill guide support in a dry bone space, so that the first surface of the bone engagement structure engages the first bone accordingly; and - passing a surgical instrument through a second opening defined by the drill guide to establish an intramedullary canal within the first bone that is substantially collinear to a mechanical axis of the first bone.
[0007] These and other features and advantages of the present invention will be more fully described or made obvious by the following detailed description of the preferred embodiment of the present invention, which should be considered in conjunction with the accompanying drawings in which like numbers refer to like parts and in which: Figure 1 illustrates the bones of a human foot and ankle: Figures 2A and 2B are schematic representations of a scanned image of the joint of a human foot and ankle; Figure 3 is a perspective view of tibial and talar resection guides located in parts of a tibia and a talus; Figure 4 is an exploded perspective view of a support for tibial cut guide and tibial resection guide; Figure 5 is a perspective view of a tibial cut guide arranged within a support for tibial cut guide located in a lower part of the tibia; Figure 6 is an elevated front view of a tibial cut guide arranged within a support for tibial cut guide located in a lower part of the tibia; Figure 7 is a side elevation view of a tibial cut guide arranged within a support for tibial cut guide located in a lower part of the tibia during resection of the tibia; Figure 8 is a schematic representation of a resected tibia following the application and use of the tibial cut guide and support for tibial cut guide; Figure 9 is a perspective view of a talar cutting guide arranged within a support for talar cutting guide; Figure 10 is an exploded perspective view of the talar cut guide holder and the talar cut guide illustrated in Figure 9; Figure 11 is a perspective view of the talar cutting guide disposed within the support for the talar cutting guide located in an upper part of the talus; Figure 12 is an elevated front view of the talar cutting guide disposed within the support for the talar cutting guide located in the upper part of the talus; Figure 13 is a side perspective view of the talar cutting guide arranged within the support for the talar cutting guide located in a lower part of the talus during resection of the talus; Figure 14 is a schematic representation of a resected talus following the application and use of the talar cut guide and support for the talar cut guide; Figure 15 is a schematic representation of the resected joint space following the application and use of the supports for the talar and tibial cutting guide and cutting guides; Figure 16 is a perspective view of an example of a custom tibial drill guide holder; Figure 17 is an elevated front view of the tibial drill guide holder illustrated in Figure 16; Figure 18 is a rear elevation view of the tibial drill guide holder illustrated in Figure 16; Figure 19 is an elevated bottom view of the tibial drill guide holder illustrated in Figure 16; Figure 20 is an elevated top view of the tibial drill guide holder illustrated in Figure 16; Figure 21 is a perspective view of an example of a tibial drill guide; Figure 22 is a side elevation view of the tibial drill guide shown in Figure 21; Figure 23 is an elevated top view of the tibial drill guide shown in Figure 21; Figure 24 is an exploded perspective view of the tibial drill guide holder and tibial drill guide; Figure 25A is a side elevation view of the tibial drill guide disposed within the support for tibial drill guide being inserted into the resected joint space; Figure 25B is a perspective view of the mounting of the support for tibial drill guide and tibial drill guide disposed within the resected joint space; Figure 25C is a perspective view of the support set for tibial drill guide and tibial drill guide arranged and fixed within the resected joint space; Figure 26 is a perspective view of an example of an alignment instrument; Figure 27 is an exploded perspective view of the alignment instrument shown in Figure 26; Figures 28A and 28B illustrate the relative movement allowed between each of the components of the alignment instrument illustrated in Figure 26; Figure 29 is a perspective view of an example of an adapter bar for coupling the bracket assembly for tibial drill guide and tibial drill guide to the alignment instrument; Figure 30 is a perspective view of the adapter bar coupled to the mounting of the bracket for tibial drill guide and tibial drill guide and the alignment instrument; Figure 31 is a top isometric view of another example of an alignment instrument / foot support assembly for use with a tibia drill guide support! and tibial drill guide: Figure 32 is a lower isometric view of the alignment instrument / foot support set illustrated in Figure 31; Figure 33 is an elevated front view of the alignment instrument / foot support assembly illustrated in Figure 31; Figure 34 is a side elevation view of the foot alignment / support assembly shown in Figure 31; Figure 35 is a top isometric view of another example of an alignment instrument / foot support assembly used with the support for tibial drill guide and tibial drill guide; Figure 36 is an elevated top view of the alignment instrument / foot support assembly illustrated in Figure 35; Figure 37 is an elevated front view of the foot alignment / support assembly shown in Figure 35; Figure 38 is a side elevation view of the foot support / alignment instrument set shown in Figure 35; Figure 39 is a perspective view of another example of a support for tibial cut guide; Figure 40 is an elevated front side view of the tibial cutting guide support illustrated in Figure 39; Figure 41 is a side elevation view of the support for tibial cutting guide illustrated in Figure 39; Figure 42 is an upper side view of the tibial cutting guide support illustrated in Figure 39; Figure 43 is a lower side view of the support for tibial cutting guide illustrated in Figure 39; Figure 44 is a perspective view of a tibial drill guide cartridge for use with the tibial drill guide holder illustrated in Figure 39; Figure 45 is a front end view of the tibial drill guide cartridge illustrated in Figure 44; Figure 46 is a bottom side view of the tibial drill guide cartridge illustrated in Figure 44; Figure 47 is a side view of the tibial drill guide cartridge illustrated in Figure 44; Figure 48 is an exploded perspective view of a mounting plate and dowels configured for use with the tibial drill guide support illustrated in Figure 39; Figure 49 is a partially exploded perspective view of a mounting plate and dowels configured for use with the tibial drill guide support illustrated in Figure 39; Figure 50 is a partially exploded perspective view of a mounting plate, dowels and support for tibial drill guide configured to receive a guide cartridge for tibial drill according to Figure 44; Figure 51 is a perspective view of the tibial drill guide holder, tibial drill guide cartridge, dowels and mounting plate assembled in sets; Figure 52 is a side view of the assembly shown in Figure 51; Figure 53 is an upper side plan view of the assembly shown in Figure 51; Figure 54 is a bottom side view of the assembly shown in Figure 51; Figure 55 is a perspective view of the foot support assembly for use with the assembly shown in Figure 51; Figure 56 is a perspective view of a pivoting arrangement used to attach to the assembly shown in Figure 51 in the foot support assembly; Figure 57 is an upper side plan view of the foot support assembly shown in Figure 55; Figure 58 is a side view of the foot support assembly shown in Figure 55; Figure 59 is an opposite side view of the foot support assembly shown in Figure 55; Figure 60 is a view of the rear end of the foot support assembly shown in Figure 55; Figure 61 is a view of the front end of the foot support assembly shown in Figure 55; Figure 62 is a perspective view of a drill bit being passed through the foot support assembly and tibial drill guide; DETAILED DESCRIPTION OF THE INVENTION
[0008] This description of the preferred embodiments is intended to be read in conjunction with the accompanying drawings, which should be considered part of the entire written description. The figures in the drawings are not necessarily to scale and certain characteristics can be shown in an exaggerated scale or in a somewhat schematic form for the sake of clarity and conciseness. In the description, relative terms, such as "horizontal", "vertical", "up", "down", "top" and "bottom", as well as their derivatives (for example, "horizontally", "down", " up ", etc.) must be interpreted with respect to the orientation as then described or illustrated in the figure of the drawings under discussion. These relative terms are for convenience of description and should not normally be considered as a particular guideline. Terms including "inward" versus "outward", longitudinal versus "lateral" and the like must be interpreted in relation to each other or in relation to an elongation axis or axis or center of rotation, as the case may be. Terms relating to attachments, couplings and the like, such as "connected" and "interconnected" refer to the relationship in which the structures are attached or fixed to each other, either directly or indirectly through intervening structures, as well as fixed or mobile or rigid relationships , unless expressly described otherwise. When only a single machine is illustrated, the term "machine" should also be considered to include any set of machines that individually or jointly execute a set (or several sets) of instructions to carry out one or more of the methodologies described in the present invention. The term "operably connected" is a fixation, coupling or connection that allows relevant structures to function as intended by virtue of that relationship. In the claims, means-plus-function clauses, if used, are intended to cover the structures described, suggested or made obvious by the written description or drawings to perform the function in the present invention, including not only structural equivalents, but also equivalent structures.
[0009] The described systems and methods advantageously use surgical instruments, guides and / or fixation devices manufactured especially based on the patient's anatomy to reduce the use of fluoroscopy during a surgical procedure. In some cases, the use of fluoroscopy during a surgical procedure can be eliminated completely. Custom instruments, guides and / or fixation devices are created by images made of the patient's anatomy using computed tomography ("CT") equipment, an magnetic resonance imaging ("MRI") machine or similar medical imaging technology before surgery and using these images to create patient-specific instruments, guides and / or fixation devices.
[0010] Although the following description of patient-specific instruments is made with respect to a foot 10 and ankle 12 (fig. 1), a person skilled in the art will understand that systems and methods can be used with respect to other joints, including, among others. others, knees, hips, shoulders and the like. As illustrated in figure 1, a typical human foot 10 includes an ankle joint 12 formed between the talus 14, which is arranged on the heel 20 and the tibia 16 and fibula 18.
[0011] A scanned CT or MRI image or series of images can be taken from a patient's ankle 12 (or from another joint) and then converted, for example, from the DICOM image format into a three-dimensional computerized model of the ankle, including the calcaneus, talus, tibia, navicular and fibula to determine the alignment, type and sizing of the implant using specialized modeling methods that are often incorporated into the software. Computer-generated three-dimensional models derived from CT or MRI image data often include accurate and accurate information regarding the surface contours around the structures that were the object of the image, for example, the surface topography of the bones or the contour of the bone. fascia that were the object of the image. It will be understood that with surface topography we mean the location, shape, size and distribution of surface characteristics, such as hollows and protuberances or the like.
[0012] It was found that the methods described in the US patent US 5,768,134 granted to Swaelens et a /., Which is incorporated in its entirety by reference in the present invention, produced adequate conversions of CT and MRI image data for three-dimensional models per computer. In some embodiments, the images are taken from a foot 10, that is, the calcaneus 20, talus 14, tibia 16 and fibula 18 of a patient using a tomograph or MRI machine or another device for capturing and processing digital images such as understood by a technician on the subject. The image data is processed in a processing unit, after which a model 50 is generated using the digitized image data processed as illustrated in figures 2A and 2B.
[0013] Interactive processing and preparation of the scanned image data is carried out, which includes the manipulation and introduction of additional extrinsic digital information, such as predefined reference locations 52 for positioning and aligning the components so that adjustments in the operating room 54, which it will need resection during the surgery, can be planned and mapped in the computerized model 50 (Figures 2A and 2B). After the interactive processing of the scanned image data, it is possible to return to the original CAD data to obtain a digital representation with higher resolution of surgical instruments, prostheses, guides or specific patient fixation devices in order to add this digital representation to the data model of patient image.
[0014] Figure 3 illustrates a pair of personalized cutting guides for ankle replacement surgery including a support for fibial resection guide 100 and a support for talar resection guide 102, which are formed and mounted on the patient's lower tibia 16a and upper talus 14a. A custom tibial drill guide holder 200 (Figures 16 to 20) is also formed and configured to be received within the ankle space created using the custom tibial resection guide and talar brackets 100, 102. Although the custom cut guides are described to prepare a patient's talus, tibia and femur, a person skilled in the art will understand that other cutting guides can be implemented and that personalized guides can be created for other joints, including, but not limited to, knee, hips, shoulder or other articulation.
[0015] The support for tibial resection guide 100 shown in Figure 3 is formed from a resilient polymer material of the type that is suitable for use in conjunction with stereolithography, selective laser sintering or similarly manufactured equipment. The resection guide holder 100 includes a unitary body including a cruciform tibial connection 104 that projects upwardly from the base 106 which further defines a recess for the guide receptacle 108, as best seen in figure 4. A cruciform connection 104 includes a pair of spaced arms 110, 112 protruding outwardly from a central column 114. Arms 110, 112 and the central column 114 each having a bony engagement surface conforming to 116 which is complementary to the contours of a corresponding part of the patient's lower tibia 16a as illustrated in figure 7. By means of the imaging operations discussed above, the bone engaging surfaces according to 116 of the arms 110, 112 and the central column 114 are configured for complementary fitting with the anatomical surface characteristics of a selected region of the patient's natural bone. For the tibial resection guide support 100, the selected bone region comprises the lower surfaces of the patient's tibia 16a.
[0016] As best seen in figures 3 to 5, a pilot block 118 protrudes outwardly from the central column 114 adjacent to the intersection of arms 110, 112. A support block 120 (figure 4) is located at the base 106 in relation to spaced with the pilot block 118. The recess of the guide receptacle 108 is defined by a pair of wings 122, 124 that extend outwards from each side of the central column 114 in opposite directions at the base 106, with the support block 120 located between them. Each wing 122, 124 includes a pillar 126 projecting outwardly from the base 106 to provide lateral support for the tibial resection guide 132 (figures 4 and 5). An elongated groove 128 is defined transversely in a central part of the base 106 below the pilot block 118, but above the support block 120. Each wing 122, 124 also defines a respective groove 130 that is oriented at an angle to the central column 114. In some embodiments, grooves 130 are arranged at an angle not perpendicular to the central column 114, although one skilled in the art understands that grooves 130 can be arranged at angles perpendicular to the direction in which the central column 114 extends. Slots 128 and 130 are dimensioned and molded to allow a typical surgical saw 60 (figure 7) of the type often used for bone resection, to pass through a correspondingly positioned and sized slot in the non-contact resection guide 132, or with only incidental contact with the support for resection guide 100.
[0017] Referring again to Figure 4, the tibial resection guide 132 includes a pair of arms 134 that project downwardly and outwardly in divergent angular relation from the ends of a bridge beam 136. The shape of the tibial resection guide 132 it is complementary to the shape of the recess for the guide receptacle 108, as defined by the inward facing surfaces of the pilot block 118, support block 120 and pillars 126. The bridge beam 136 defines an elongated groove 138 which aligns with the groove 128 when the tibial resection guide is coupled and supported by the resection guide support 100. Each arm 134 defines a respective groove 140 which aligns with a respective groove 130.
[0018] The inward facing surfaces 142 of the pilot block 118, support block 120 and pillars 126 that together define the recess for the guide receptacle 108 have a shape that is complementary to the external profile of the tibial resection guide 132. The recess for the receptacle guide 108 is dimensioned to accept the tibial resection guide 132 with a "fit". By fitting it is understood that the inward facing surfaces 142 of the pilot block 118, support block 120 and the pillars 126 are sufficiently resilient to flex or compress elastically in order to store elastic energy when the tibial resection guide 132 is pushed into the recess for the guide receptacle 108. Of course, it can also be understood that the tibial resection guide 132 will have an external peripheral shape that is complementary to the circumferential shape of the recess for the guide receptacle 108, but of slightly larger size for modes of realization of fitting. Also, the tibial resection guide 132 can be retained within the recess for the guide receptacle 108 only by friction engagement with the surfaces facing into the pilot block 118, support block 120 and pillars 126. In some embodiments, the tibial resection guide 132 can simply slide into the recess into the guide receptacle 108 without operative contact or only with incidental engagement with the surfaces facing inside the pilot block 118, support block 120 and pillars 126.
[0019] Referring now to Figures 9 and 10, a support for talar resection guide 102 is formed from a resilient polymer material of the type that is suitable for use in conjunction with stereolithography, selective laser sintering or similarly manufactured equipment, for example. For example, a quick prototype polyamide powder material is suitable for use in conjunction with selective laser sintering. The support for talar resection guide 102 also includes a bony engagement surface conforming to 144 that is complementary to the contours of a corresponding part of the patient's upper talus 14a (figures 11 and 13). Through the imaging operations discussed above, the bone engagement surface according to 144 of the support for talar resection guide 102 is configured to complement the anatomical surface characteristics of a selected region of the patient's natural bone. For the support for talar resection guide 102, the selected bone region comprises the outer, upper surfaces of the patient's talus.
[0020] The talar resection guide support 102 comprises a unitary block that defines a recess for central guide receptacle 146 and a pair of through holes (figure 10). The guide receptacle recess 146 is defined by the inwardly facing surfaces 150 of a pair of wings 152, 154 that project outwardly in opposite directions from a base 156. Each wing 152, 154 includes a pillar 158 that extends it projects upwards to support the guide housing 160, so that an elongated groove 162 is defined within the base 156 and below the guide housing 160 (figures 10 and 11). The groove 162 is dimensioned and molded to allow a typical surgical saw 60, of the type frequently used for bone resection, to pass through a correspondingly positioned and sized groove 164 in the talar resection guide 166 without contact, or just with contact incidental with the talar resection guide locator 102 (figures 11 and 13). An annular wall 168 having a shape that is complementary to the external profile of the talar resection guide 166 projects outwardly in relation substantially perpendicular to a rear wall and in order to further define the recess for guide receptacle 146.
[0021] Still referring to figures 9 and 10, the talar resection guide 166 includes a pair of parallel and facing plates 170, 172 that define an elongated groove 164 between them and are joined together at their ends by means of wings 174. Thus , the shape of the talar resection guide 166 is complementary to the shape of the recess for the guide receptacle 146 as defined by the inward facing surfaces 150 of the wings 152, 154, base 156 and pillars 158. The recess for the guide receptacle 146 is dimensioned in order to accept the talar 166 resection guide with a snap. Naturally, it should also be understood that the talar resection guide 166 will have an external peripheral shape that is complementary to the circumferential shape of the recess for guide receptacle 146, but with a slightly larger size for plug-in embodiments. Also, the talar resection guide 166 can be retained within the recess for guide receptacle 146 only by friction engagement with the inward facing surfaces 150 of the wings 152, 154, base 156 and pillars 158. In some embodiments, the talar resection guide 166 can simply slide into the recess for guide receptacle 146 without operating contact or just incidental engagement with the inward facing surfaces 150 of the wings 152, 154, base 156 and pillars 158.
[0022] The tibial drill guide holder 200 illustrated in figures 16 to 20 can also be manufactured from a resilient polymer material of the type that is suitable for use in conjunction with stereolithography, selective laser sintering or similar manufacturing equipment, for example , a rapid prototype polyamide powder material is suitable for use in conjunction with selective laser sintering. As shown in figures 16 to 20, the tibial drill guide holder 200 includes a somewhat rectangular body 204 which defines an opening 206 extending from an upper surface 208 of body 204 to a lower surface 210 of body 204. The upper surface 208 of the body 204 may include a pair of chamfers 212 that are dimensioned and configured to fit the desiccated surfaces of the lower tibia 16a (figure 8). Put another way, the top or top surface 208 of body 204, including chamfers 212, is complementary to the geometry and groove locations 138 and 140 of the tibial resection guide 132.
[0023] The front side 214 of the body 204 defines one or more blind holes 216. As illustrated in the embodiment shown in figure 17, the body 204 can define three blind holes 216-1, 216-2 and 216-3. In some embodiments, blind holes 216-1 and 216-2 can be enlarged holes that are sized and configured to receive a pin and blind hole 216-3 can also be an enlarged hole to receive a pin or blind hole 216- 3 can be threaded to engage a screw, as described below.
[0024] Opening 206 may have a circular cross-sectional area and include a shoulder 218 that has a reduced diameter compared to opening 206 and includes an anti-rotation element 220, as best seen in Figure 20. Anti-rotation element 220 of the shoulder 218 may include a or more flat or other geometric structures to prevent the tibial drill guide 202 from rotating with respect to the tibial drill guide holder 200 when the tibial drill guide 202 is disposed within the opening 206.
[0025] Extending from the body 204 of the tibial drill guide support 200 are the tibial engagement structure 222 and the talar engagement structure 224. The outer surface 226 of the tibial engagement structure 222 may have a rectangular shape that is substantially planar and the internal and substantially conforming engagement surface 228 of the tibial engagement structure 222 may be somewhat convex to engage the patient's tibia 16. The tibial engagement structure 222 can define one or more holes 230 to receive a k wire or pin, as described below.
[0026] The talar engagement structure 224 can also include a substantially planar and rectangular outer surface 232. The lower portion 234 of the talar engagement structure 224 can be a conforming surface that has a geometry that matches the geometry of the talar bone 14 (figure 14) . The talar engagement structure 224 can also define one or more holes 236 sized and configured to receive a k wire, as described below.
[0027] Preferably, the tibial drill guide 202 illustrated in figures 21 to 23 is manufactured from a material that has more structural integrity than the tibial drill guide holder 200 to enable the drill guide 202 to guide a drill without being damaged. Examples of materials include, but are not limited to, metals, ceramics or the like. The drill guide 202 has a first cylindrical shaped part 238 that is dimensioned and configured to be received within the part of the opening 206 that extends through the shoulder or reduced diameter area 218. A second part 240 of the drill guide 202 has a cross-sectional diameter larger than the first part 238 and is dimensioned and configured to be received inside the opening 206 of the tibial drill guide holder 200. A flattened part 242 which is best seen in figures 21 and 23, is formed at the along an outer surface 244 of the first part 238 of the drill guide 202. The inner surface 248 of the second part 240 of the tibial drill guide 202 has a tapered shape that intersects and communicates with the aperture 246 so that a drill or reamer can be received through drill guide 202.
[0028] As with the digital imaging models 50 described above and considering a generalized digital model of a support for tibial resection guide 100 added to the patient's lower tibia image data, the characteristics of the anatomical surface of the patient's lower tibia, for example , the surface topography can be complementarily mapped on the bone engaging surfaces according to 116 of the arms 110, 112 and central column 114, that is, the surfaces that engaged the exclusive surface topography of the bones, from the support for tibial resection guide 100. It will be understood that the complementary mapping of the digital images results in protuberances located on the surface of a bone that turns into hollows located on the surfaces of bony engagement according to 116 of the arms 110, 112 and central column 114 of the support for tibial resection guide 100, while the concavities located on the surface of a bone turn into local protuberances located on the bony engagement surfaces according to 116 of the arms 110, 112 and central column 114,
[0029] Each of the bone engaging surfaces according to 116 of the arms 110, 112 and central column 114 of the support for resection guide 100 is redefined with a substantially mirrored complementary image of the characteristics of the anatomical surface of a selected region of the patient's lower tibia 16a. As a consequence of this complementary bone surface mapping, the support for tibial resection guide 100 "locks" reliably in the complementary topography of the corresponding part of the patient's natural tibia without the need for other external or internal fixation and orientation devices. In other words, the fitting of the roughness of the bone surface in its corresponding hollows formed in the bone engaging surfaces according to 116 of the tibial resection guide support 100 ensures that little or no relative movement occurs, that is, lateral slips between the guide support tibial resection 100 and the tibial surface.
[0030] A substantially identical mapping is performed with respect to the design of a support for the patient's specific talar resection guide 102 and support for the tibial drill guide 200. In a special way, the mapping for the design of the support for the tibial drill guide 200 is performed extrapolating where the resections of the tibia 16 and talus 14 will be done using the tibial resection guide and talar supports 100 and 102 and mapping the support for tibial drill guide 200 in the extrapolated geometry of the tibia and talus.
[0031] A visual presentation of the results of virtual alignment between the patient's lower tibia 16a and support for resection guide 100, the patient's upper talus 14a and support for resection guide 102 and the proposed resected area that should be created by resection of the talus 14 and the tibia using the tibial resection guide support 100 and the talar resection guide support 102 are created and sent to the surgeon for approval of the results prior to manufacture. In addition, the surgeon can receive a visual representation of the results of virtual alignment between the proposed resected joint space and support for tibial drill guide 200 are created and sent to the surgeon for approval of the results prior to manufacture. Upon receipt of the surgeon's approval, the resection guide holder 100, the resection guide holder 102 and tibial drill guide holder 200 are manufactured and returned to the surgeon for use in surgery.
[0032] During a total ankle replacement, for example, the surgeon makes an anterior incision to gain initial access to the ankle joint. The surgeon guides the support for tibial resection guide 100 in the lower tibia 16a until the bony engagement surfaces according to 116 of the arms 110, 112 and central column 114 of the support for tibial resection guide 100 engage firmly with each other in order to " interlock "reliably with the topography of the exposed surface of the lower tibia 16a as best seen in figures 5 to 7. With the support for tibial resection guide 100 locked in the patient's lower tibia 16a, a surgeon fits a configured distal resection guide appropriately 132 in the recess for the guide receptacle 108 of the tibial resection guide support 100. This results in the resection guide support 100 being placed between the resection guide 132 and the patient's bone tibia 16a (figures 5 and 6). With the support for the resection guide 100 positioned precisely in relation to the selected bone region and the support for the resection guide 100 properly built fixed to the 1 bone of the patient due to the fit of the roughness of the bone surface in its corresponding hollows formed on the surfaces of bone coupling according to 116, the surgeon uses a conventional surgical blade 60 and the resection grooves 128 and 130 of the resection guide 132 to resect the patient's bone 16 (figures 7 and 8).
[0033] Similarly, when the talar resection guide support 102 is added to the patient's talar image data, the anatomical surface characteristics of the patient's upper talus, that is, the surface topography can be mapped complementarily on the bone engagement surface according to 144. It must be understood, again, that the complementary mapping of digital images results in protrusions located on the surface of a bone that turns into hollows located on the surface of the bone engaging according to 144, while the hollows located on the surface of a bone are they transform into protuberances located on the bone engaging surface as per 144. In this way, the bone engaging surface as 144 is redefined with a substantially mirrored complementary image of the characteristics of the anatomical surface of a selected region of the patient's lower tibia. As a consequence of this complementary bone surface mapping, the talar resection guide support 102 “locks” reliably in the complementary topography of the corresponding part of the patient's natural talus without the need for other external or internal fixation and orientation devices.
[0034] To continue the total replacement of the ankle, the surgeon guides the support for resection guide 102 in the upper talus 14a until the bone engaging surface as 144 of the support for resection guide 102 "locks" in the topography of the exposed surface of the upper talus 14a (figure 11). With the resection guide support 102 locked in the patient's upper talus, a surgeon fits a properly configured distal resection guide 166 into the recess for the guide receptacle 146 of the talar resection guide support 102. This results in the resection guide support resection 102 be placed between the resection guide 166 and the patient's bone 14 (figures 12 and 13). With the support for the resection guide 102 positioned precisely in relation to the selected bone region and the resection guide 166 and support for guide 102 properly constructed and fixed to the patient's bone due to the fit of the roughness of the bone surface in their corresponding concavities formed on bone engagement surfaces in accordance with 144, the surgeon uses a conventional surgical blade 60 and the resection groove 164 of the resection guide 166 to resect the patient's bone 14 (figures 13 and 14).
[0035] Once the tibia 16 and talus have been resected, the support for tibial drill guide 200 and tibial drill guide 202 are coupled and installed in the resected joint space 22 (figure 15). The tibial drill guide holder 200 and the tibial drill guide 202 are coupled by inserting the first part 238 of the tibial drill guide 202 into the opening 206 defined by the body 204 of the tibial drill guide holder 200 (figure 24). The flat part 242 formed in the first part 238 of the tibial drill guide 202 is aligned with the anti-rotation element 220 of the shoulder 218, so that the tibial drill guide 202 slides into the opening 206 until a lower surface 250 of the second part 240 of drill guide 202 contact and lean against the shoulder 218 of the tibial drill guide support 200.
[0036] The body 204 of the tibial drill guide holder 200, in which the tibial drill guide 202 is arranged, is inserted into the resected joint space 22 in a posteroanterior direction with chamfers 212 that slide along the parched areas of the tibia 16 formed using grooves 140 of the tibial resection guide 132, as best seen in figures 25A and 25B. The support set for tibial drill guide 200 and tibial drill guide 202 is slid into the resected joint space 22 until the talar engagement structure contacts the talus 14. A surgeon can move the support for tibial guide 200 into the joint space resected until the surface according to 228 is properly fixed to the patient's bone due to the fit of the roughness of the bone surface in their corresponding hollows formed on the bone engaging surface according to 228. Once properly located, the k 62 wires can be inserted in the holes 230 and / or holes 236, respectively defined by the tibial engagement structure 222 and the talar engagement structure 224 to fix the support assembly for tibial drill guide 200 and tibial drill guide 202 to the patient's tibia 16 and talus 14, as illustrated in figure 25C.
[0037] With the tibial drill guide support 200 and tibial drill guide 202 fixed within the resected joint space 22, the patient's leg is inserted into a foot support and alignment instrument 300. Figures 26 to 28B illustrate an example of a alignment instrument 300, which serves to support the ankle joint during a prosthesis installation procedure. The alignment instrument 300 includes a foot support set 302 and a leg rest 304. The foot support set 302 includes a foot rest 306, to which the foot is attached by means of a clamp. foot 310 and heel clips 308 during a prosthesis installation procedure. The calf of the leg is correctly attached to the leg rest 304 as soon as the ankle joint is dried and the tibial drill guide support 200 and tibial drill guide 202 are installed. Together, the foot support assembly 302 and footrest 304 secure the foot and ankle in relation to the leg during an installation procedure.
[0038] As illustrated in Figure 26, the foot support set 302 is dimensioned and configured to pivot under the doctor's control, from a vertical or upright condition (shown in solid lines in figure 26) towards a more horizontal or inclined condition ( shown in dotted lines in figure 26). In the upright condition, the set 302 serves to hold the ankle joint in the desired orientation with respect to the natural anteroposterior and medial to lateral axes.
[0039] As best seen in Figure 27, the foot support assembly 302 includes a rear plate 312 and an intermediate plate 314, which is placed between the footrest 306 and the rear plate 312. The intermediate plate 314 is attached to the footrest for foot 306 by sliding articulated couplings 316 for upward and downward movement (i.e., vertical) in relation to the footrest 306. A pair of opposite spaced alignment rods 318 is carried by intermediate plate 314.
[0040] The alignment rods 318 are arranged in the same horizontal plane and extend from the intermediate plate 314 through vertically elongated grooves 320 defined by the footrest 306 so that the rods 318 are arranged on opposite sides of the tibia in the middle plane to lateral when a foot is supported by the foot support assembly 302. The vertical movement of the intermediate plate 314 moves the alignment rods 318 up and down in unison within the grooves 320 on opposite sides of the footrest 306 (figure 28A).
[0041] The rear plate 312 is coupled to the intermediate plate 314 by sliding the articulated couplings 322 for side-by-side (i.e. horizontal) movement in relation to the footrest 306. as illustrated in Figure 28B. Back plate 312 also carries a bushing 324 that passes through the openings 326 defined by intermediate plate 314 and footrest 306 and ends at or near the plane of the footrest 306 against which the sole of the foot comes into contact . The center of the bushing 324 coincides with the intersection of the horizontal plane of the stems 318.
[0042] An adapter bar 400 for attaching the tibial drill guide holder 200 to the alignment instrument 300 is illustrated in Figure 29. The adapter bar 400 includes an elongated body 402 which extends linearly from a first end 404 to a second end 406. Each end 404, 406 includes a respective extension 408, 410 extending from elongated body 402 at an angle. In some embodiments, extensions 408 and 410 extend orthogonally from the elongated body 402, although one skilled in the art may understand that these extensions 408 and 410 may diverge from the elongated body 402 at other angles. In some embodiments, the elongate body 402 may not be linear in shape, but rather curved or arched, as will be understood by one skilled in the art.
[0043] Each extension 408 and 410 defines a respective hole 412, 414 which is dimensioned and configured to receive the alignment rods 318 extending from the alignment instrument 300 in a sliding manner. The elongated body 402 defines one or more holes 416-1 , 416-2 and 416-3 (collectively referred to as "416 holes") for coupling the adapter bar 400 to the tibial drill guide holder 200. In some embodiments, one or more holes 416 line up with one or more holes 216 defined by the body 204 of the tibial drill guide holder 200, so that a pin or other device to maintain the alignment and engagement of the adapter bar 400 and support for the tibial drill guide 200. For example, the holes 216- 1 and 216-2 of the holder for the tibial drill guide 200 align with the holes 416-1 and 416-2 of the adapter bar 400 and hole 216-3 of support for the drill guide 200 aligns with the hole 416- 3 of the adapter bar 400. Bolts 70 (hand strips in figure 25C) can be inserted into holes 216-1 and 416-1, as well as holes 216-2 and 416-2 to align the tibial drill guide support 200 with the adapter bar 400 in both the horizontal and horizontal directions. vertically (for example, in the x and y directions) and a screw (not shown) can be inserted through hole 416-3 into threaded hole 216-3 to secure the tibial drill guide bracket 200 to the adapter bar at height or depth appropriate (for example, in the z direction).
[0044] With the tibial drill guide support 200 and the tibial drill guide 202 arranged within the dry ankle space 22, the foot and lower leg are placed on the footrest 306 and legrest 304 (figure 30). The doctor estimates the dorsal plantar rotation axis of the ankle and visually aligns the ankle to the rotation axis of the alignment instrument 300. The footrest 306 is adjusted to rotate the foot so that the toe is essentially pointing in a vertical direction with respect to the leg that extends in the horizontal direction. The front of the foot and the heel are fixed to the footrest 306 with cleats 308 and 310. The legrest 304 is adjusted on the calf so that the tibia 16 is approximately parallel to the floor.
[0045] The foot and α calf are desirably aligned so that the anteroposterior line ("A-P") of the talus trochlea is essentially vertical.
[0046] The adapter bar 400 is coupled to the alignment instrument 300 through alignment holes 412 and 414 which are defined by extensions 408 and 410, respectively, with the alignment rods 318 of the alignment instrument 300. The adapter bar 400 is then slid along the alignment rods 318 until the holes 416 of the adapter bar align with the holes 216 defined by the body 204 of the tibial drill guide 202 (figure 30). As described above, dowels 70 are inserted into holes 416-1 and 416-2 of the adapter bar 400 and support holes 216-1 and 216-2 for tibial drill guide 200. With dowels 70 arranged inside the holes 216-1,216-2, 416-1 and 416-2, the support for tibial drill guide 200 is properly aligned with the alignment instrument 300 in the medial lateral (for example, x direction) and superinferior (for example, y direction) ). A screw is inserted through hole 416-3 into threaded hole 216-3, which secures the tibial drill guide holder 200 to the adapter bar 400 and provides correct alignment in the anteroposterior direction (for example, the zj direction.
[0047] With the patient's foot disposed inside the alignment instrument 300, the bushing 324 on the back plate 312 establishes alignment with the mechanical axis of the tibia 16 and alignment of the stems 318. Therefore, after using the adapter bar 400 to align the support for tibial drill guide 200 with the alignment instrument 300 as described above, it is possible to drill in line with the center of the ankle and tibia for the introduction of a cannula in the sole of the foot without the use of fluoroscopy, as the opening 246 of the tibial drill guide 202 disposed within the support for fibial drill guide 200 is aligned with an axis defined by bushing 324. This arrangement enables an intramedullary channel to be formed which is substantially collinear to the mechanical axis defined by the tibia.
[0048] Various minimally invasive surgical techniques can be used to introduce a cannula into the sole of the foot in the calcaneus 20, talus 14 and tibia 16. In a representative embodiment, the bushing 324 is temporarily separated from the flask plate 312 (for example, unscrewing) to provide access to the sole of the foot. The doctor uses a scalpel to make an initial incision in the sole of the foot and replaces the chuck 324. A cannulated trocar loaded with a k-thread (not shown) can be inserted through the chuck 324, in the sole of the foot, until the heel 20 is contacted and the wire k is firmly fitted inside the heel 20. The trocar can then be removed and the wire k lightly tapped further into the heel 20. In a representative embodiment, bushing 324 measures 6 mm in diameter and the exchange cannulated can be loaded to 6 mm with a 2.4 mm k wire. The doctor can now operate a first cannulated reamer (for example, 6 mm) (not shown) on the k-wire up the heel 20 and talus 14. The first reamer opens an access path for introducing a cannula into the sole of the foot.
[0049] After removing the first reamer and bushing 324, the doctor then inserts a cannula into the sole of the foot 64, as shown in figure 30. With the cannula in the sole of the foot 64 installed, a second reamer 66 (for example, 5 mm) can be operated through the cannula 64 to drill approximately 100 mm more through the talus 14 and ascend to the tibia 16 to establish an inframedullary guide path through the calcaneus 20 and the talus 14 leading to the tibia 16 (figure 30). As the second reamer 66 advances in the direction of the tibia 16, the tip 68 of the reamer 66 is guided by the tapered inner surface 248 of the tibial drill guide 204, which is aligned with the bushing 324 of the alignment instrument 300.
[0050] As soon as an intramedullary canal is established through the calcaneus 20, talus 14 and tibia 16, the adapter sleeve 400 is detached from the drill guide holder 200 and alignment rods 318. The drill guide holder 200 is removed from the joint space resected 22 to expose the resected joint space to the surgeon.
[0051] With the space of the dry ankle joint 22 exposed to the surgeon, an ankle prosthesis is then installed. In one example, the ankle prosthesis includes a nail that can extend from the base of the calcaneus to the top of the talus (i.e., a talocalcaneal nail), although in some embodiment the nail is completely disposed within the talus ( that is, a talar stem). A convex dome is attached to the rod and provides an articulated joint surface. A tibial stem can be monolithic or include a plurality of segments that can be coupled together in place. A tibial platform attaches to the tibial stem and includes or is attached to a convex articulation surface to articulate with the surface of the articulated joint coupled to the talar / phalocalcaneal stem. Examples of such ankle prosthesis and methods of installing said prosthesis are described in United States patent US 7,534,246, issued to Reiley et al, whose integrality is incorporated by reference in the present invention.
[0052] The described tibial drill guide holder 200 and drill guide 202 can be used with a variety of alternative alignment instruments. For example, figures 31 to 34 illustrate another example of an alignment instrument in the form of a foot support assembly 500 to which the tibial drill guide support 200 can be directly attached. As shown in figures 31 and 32, the foot support assembly 500 includes a base plate 502 defining a plurality of slots 504 and 506 and an opening 503.
[0053] Slots 504 are dimensioned and configured to slide a pair of clips for the heel 508 and slots 506 are dimensioned and configured to slide a pair of clips for the front of the foot or guides 510. The clips for the heel 508 and the forelegs 510 cooperate to hold a patient's foot in the desired position with respect to the base plate 502 using a locking mechanism, such as, for example, an adjusting screw or other locking device , to fix the position of the heel clips 508 and the clips for the front of the foot 510 to the base plate 502. The respective engagement surfaces of the foot 512 and 514 of the clips for the heel 508 and clips for the front of the foot 510 can have a shape that complements the medial and lateral shape of the human foot.
[0054] Extending from the base plate 502 is a pair of alignment rods 516 arranged on the base plate 502 so that an alignment rod is arranged on one medial side of the patient's foot and the other alignment rod is placed on one side of the patient's foot. A drawbar 518 is dimensioned and configured to slidably engage the alignment rods 516, as best seen in figures 32 and 34. The drawbar 518 includes a pair of spaced legs 520 that define channels 522 (figure 32) in which the alignment rods 516 are received in a sliding way. One or both legs 520 include a clamp or other locking mechanism 524 to increase the friction between the coupling bar 518 and the alignment rods 516 in order to lock the coupling bar 518 slidably in a certain position along the length alignment rods 516.
[0055] The lateral median crossbar 526 couples the legs 520 of the coupling rod 518. Extending from the lateral median crossbar 526 is the support coupling element 528. The coupling element of the support 528 includes one or more holes 530-1, 530-2 and 530-3 (collectively called "530 holes") that are sized and configured to align with the holes 216 defined by the tibial drill guide holder 200.
[0056] A tongue 532 (figure 33) extends from the lateral median crossbar 526 to couple the shuttle engaging element 534 via the groove 536 defined by the shuttle engagement element 534. The shuttle engagement element 534 includes a shelf 538 provided of a 540 concave surface to lean against the patient's shin. A nut or other locking mechanism (not shown) can be used for the locking tongue 532, which can be threaded, to secure the position of the shelf 538 in relation to the lateral median crossbar 526.
[0057] The use of a support set for the foot 500 with respect to mounting the support for tibial drill guide 200 and tibial drill guide 202 is similar to the use of the alignment instrument 300 described above. For example, as soon as the support set for tibial drill guide 200 and tibial drill guide 202 are arranged within the resected joint space 22, the heel of the patient's foot is placed between the heel clips 508 and the front of the patient's foot is placed between the clips forwards of the foot 510. The locking mechanisms of the heel and forefoot clips 508 and 510 can be engaged to initially adjust the positions of the clips for the heel and forefoot 508 and 510 in relation to the base plate 502.
[0058] The holes 530 of the coupling element 528 are aligned with the holes 216 defined by the tibial drill guide holder 200 by sliding the legs 520 of the coupling bar 518 along the alignment rods 516. The pins 70 and / or threaded screw (not shown) ) can be used to couple the holes 530 of the coupling element 528 to the holes 216 of the tibial drill guide holder 200. The surgeon can check to ensure that the patient's foot is firm against the base plate 502 and then engage the cleats 524 so that the drawbar 518 is attached to the alignment rods 516.
[0059] The shuttle engaging element 534 is adjusted until the concave surface 540 contacts the patient's shuttle. Adjustment of the shifting engagement element 534 is guided by the engagement between the groove 536 and the tongue 532. With the shifting engagement element 534 in the desired position, the nut or other locking mechanism (not shown) locks the engagement element of cinnamon 534 in place. The surgeon can make final adjustments to the heel and forefoot clips 508 and 510 and then create the intramedullary canal as described above.
[0060] Another example of an alignment instrument 600 for use with the tibial drill guide holder 200 and tibial drill guide 202 is illustrated in figures 35 to 38. As illustrated in figure 35, the alignment instrument 600 includes a base plate 602 comprising a plurality of bars 602a, 602b and 602c. Although three bars 602a, 602b and 602c are illustrated, one skilled in the art will understand that more or less bars can be implemented. The bar 602b defines an orifice 603 sized and configured to receive a surgical instrument, such as, for example, a cannulated drill. Additional elements including, but not limited to, heel clips and / or foreleg clips (not shown) can be attached to bars 602a. 602b and 602c of base plate 602 to assist in positioning a patient's foot with respect to orifice 603.
[0061] Extending α from the base plate 602 is a pair of spaced alignment rods 604. One of the alignment rods 604 can be arranged on the middle side of the patient's leg and the other alignment rod 604 arranged on the side of the leg. of the patient. The alignment rods 604, like the alignment rods 318 of the alignment instrument 300, can be slidably received into the holes 412, 414 and adapter bar 400.
[0062] The use of the alignment instrument 600 with respect to mounting the bracket for tibial drill guide 200 and tibial drill guide 202 and the adapter bar 400 is similar to the use of the alignment instrument 300 described above. For example, once the support set for tibial drill guide 200 and tibial drill guide 202 is disposed within the resected joint space 22, the adapter bar 400 is coupled to the alignment instrument 600 by aligning the holes 412 and 414 that are respectively defined by extensions 408 and 410 with the alignment rods 604 of the alignment instrument 600. The adapter bar 400 is slid along the alignment rods 604 until the holes 416 of the adapter bar align with the holes 216 defined by the body 204 of the tibial drill guide 202. As described above, the dowels are inserted into the holes 416-1 and 416-2 of the adapter bar 400 and 216-1 and 216-2 of the tibial drill guide holder 200. With the dowels arranged inside holes 2161, 216-2, 416-1 and 416-2, the support for tibial drill guide 200 is properly aligned with the alignment instrument 600 in the middle lateral (for example, x direction) and the bottom super (eg example, y direction). A screw is inserted through hole 416-3 into threaded hole 216-3, which secures the tibial drill guide holder 200 to the adapter bar 400 and provides correct alignment in the anteroposterior direction (for example, the z direction). The surgeon can make final adjustments to the heel clips and the forefoot 508 and 510 and then create the intramedullary canal as described above.
[0063] Figures 39 to 63 illustrate another embodiment of a system for performing a surgical procedure. Specifically, figures 39 to 43 illustrate a tibial drill guide holder 702 dimensioned and configured to receive the tibial drill guide cartridge 702 illustrated in figures 44 to 47. The tibial drill guide holder 700 can also receive other cartridges from drill guide for use during other stages of surgical procedures. Like the tibial drill guide holder 200, the tibial drill guide 700 can be made of resilient polymer material of the type suitable for use with stereolithography, selective laser sintering or similar manufacturing equipment, for example, rapid prototype material polyamide powder is suitable for use with selective laser sintering.
[0064] As shown in figures 39 to 43, the tibial drill guide holder 700 has a somewhat rectangular body 704 provided with a front side 706, a rear side 708, upper side 710, lower side 712 and a pair of opposite sides 714 and 716. The front side 706 defines a recess 718 dimensioned and configured to receive the tibial drill guide 702 slidingly therein. The recess 718 communicates with a recess 720 (figures 39 and 43) defined by the lower side 712 and a recess 722 (figures 39, 42 and 43) defined by the upper side 710 so that the body 704 is substantially hollow.
[0065] The respective inner surfaces 724, 726 on the sides 714, 716 have different geometries that correspond to the cross-sectional geometry of the tibial drill guide cartridge 702 to ensure that the tibial drill guide cartridge 702 is correctly inserted into the recess 718. In the mode of embodiment illustrated in figures 39 to 43, side 716 includes first and second projections 728, 730 extending into recess 718 and side 714 has an inwardly tapered upper region 732 and an inward extending projection 734. One skilled in the art will understand that sides 714, 716 may include other features to ensure proper insertion of tibial drill cartridge 702 into recess 718. In some embodiments, sides 714, 716 may have identical geometry and the guide cartridge tibial drill bit can be reversibly inserted into recess 718,
[0066] The front side 706 defines one or more pin holes 736-1, 736-2 (collectively called “pin holes 736") sized and configured to receive a pin 70 in them. One or more through holes 738-1, 738- 2, 738-3 (collectively called "through holes 738") extend through the front side 706, which also define a blind hole 740. The through holes 738 are sized and configured to receive k wires to immobilize the guide support for tibial drill in the patient's bone, as described below.
[0067] The upper side 710 of the tibial drill guide holder 700 includes a pair of chamfers 742 that are sized and configured to fit in and with reference to the dry surfaces of the lower tibia 16a (figure 8). The tibial drill guide support 700 also includes a tibial engagement structure 744 and a talar engagement structure 746. The tibial engagement structure 744 extends from the upper side 710 and includes a substantially conforming engagement surface 748. The structure talar hitch 746 extends from the bottom side 712 and also includes a substantially conforming hitch surface 750.
[0068] The tibial drill guide cartridge 702 has a substantially rectangular elongated body 754 that can be formed from a more substantial material than the tibial drill guide support 700, such as, for example, metals, ceramics or the like. As best seen in figures 44 and 45, the geometry of sides 756. 758 is complementary to sides 714, 716, respectively, of the tibial drill guide holder 700. For example, side 758 includes projections 760 and 762 that correspond to projections 728 and 730, respectively, and side 756 includes a protrusion 764 and an angled section 766 corresponding respectively to the protrusion 734 and upper region 732 of the tibial drill guide holder 700.
[0069] The front side 768 of the tibial drill guide cartridge 700 defines a blind hole 770, which can be threaded for the reasons described below. The tibial drill guide cartridge 700 defines a pair of holes 772 and 774 that extend from the bottom surface 776 to the top surface 778. Hole 772 can be an enlarged hole sized and configured to receive a spherical retention in it and orifice 774 has an internal surface 780 that tapers from a larger diameter on the lower surface 776 to a smaller surface that is dimensioned and configured to receive a surgical instrument, such as a drill and / or reamer. The upper surface 778 defines a pair of parallel grooves 782-1, 782-2 (collectively called “grooves 782") that extend from side 756 to side 758. As best seen in figures 44 and 47, grooves 782 are arranged equidistant from a central axis defined by hole 774 to provide a visual key for a physician who wants to check the alignment of hole 774 with a mechanical axis of the patient's tibia using fluoroscopy.
[0070] As illustrated in Figure 48, a mounting plate 800 has a substantially rectangular body 802 made from a material that includes, but is not limited to, metals, ceramics or the like. The body 802 defines an opening 804 that extends from the front side 806 to the rear side 808 and whose recess 718 of the tibial drill guide holder 700 has similar geometry, so that the tibial drill guide cartridge 702 can be received in it. Body 802 also defines a pair of through holes 810-1, 810-2 (collectively called "holes 810") arranged in body 802 to match holes 738 of the tibial drill guide holder 700 and sized and configured to receive a k wire or pin on them.
[0071] A mounting base 812 extends from the front side 806 of the mounting plate 800 and defines a hole 814 that extends from a first side 816 to a second side 818. The mounting base 812 defines a notch 820 and a or more pin holes 822-1,822-2 (collectively called "holes 822") that align with holes 736 of the tibial drill guide holder 700. Notch 820 forks hole 814. Mounting base 812 can also define a or more recesses 824 corresponding to one or more protrusions 784 extending from the front side 706 of the tibial drill guide holder 700. The recesses 824 and protrusions 784 cooperate to ensure that the mounting base 812 and support for the guide tibial drill 700 are correctly aligned. One skilled in the art will understand that other geometric elements can be implemented to ensure the correct alignment between the mounting base 812 and the support for tibial drill guide 700.
[0072] As shown in figures 49 to 54, the mounting plate 800 can be attached to the tibial drill guide holder 700 using the pins 70 which are received through holes 822 and 734. The tibial drill guide cartridge 702 is received through the opening 804 and recess 718, as best seen in figure 51. Figures 53 and 54 illustrate that when the tibial drill guide cartridge 702 is properly inserted into the tibial drill guide support assembly 700 and mounting plate 800, the hole 772 aligns with hole 828 defined by mounting plate 800 which may include a spherical retainer (not shown) disposed thereon. Consequently, the spherical retention is received inside the hole 772 to retain the tibial drill guide cartridge 702 disposed inside the opening 804 and in the recess 718 so that the hole 774 is disposed inside the recesses 754 and 756. A screw or other object threaded (not shown) can be inserted into threaded hole 770 and then pulled out to remove the tibial drill guide cartridge 702 from opening 804 and recess 718, as shown in figures 53 and 54.
[0073] The tibial drill guide holder 700, the tibial drill guide 702 and the mounting plate 800 can be used in conjunction with the alignment instrument 300, adapter bar 400, foot support set 500 and alignment instrument 600 , as described above. In addition, the tibial drill guide support 700, the tibial drill guide 702 and mounting plate 800 can also be used in association with the foot support set 900 illustrated in figures 55 to 60, as can the support for tibial drill guide 200 and tibial drill guide 202.
[0074] As shown in figure 55, the foot support assembly 900 includes a base plate 902 that extends from a first end 904 to a second end 906. First and second ends 904, 906 define a pocket 908 and a hole 910. Pocket 908 is sized and configured to receive a drill chuck 912 that has a cylindrical body defining hole 914 that aligns with through hole 910. Consequently, both the first end 904 and the second end 906 can support the ankle or front of a patient's foot. Each pocket 908 includes a spring loaded retainer 916 coupled communicating with it and including a finger receiving surface 918 and is configured to slide in relation to the base plate 902 and secure the drill chuck 912 inside pocket 908. In in some embodiments, the drill chuck can be threaded and configured to be coupled to the base plate 902 with complementary threads arranged on the inner surface of the holes 910.
[0075] The base plate 902 also includes a medial / lateral extension 920 that extends in a substantially perpendicular direction from an approximate intermediate point between the first end 904 and the second end 906. The base plate 902 can also define an opening for view 922 so that the surgeon is able to view the patient's sole of the foot when the foot is attached to the foot support assembly 900.
[0076] One or more rods 924 extend from the base plate 902 substantially perpendicular to the holding surface of the upper foot 926 (figure 56). The rods 924 can be attached to the base plate 902 using screws or other means of fixation, as will be understood by a person skilled in the art. A cap 928 is attached to the upper end of the stems 924 and to the stems 924 using screws or other fastening means.
[0077] A mounting element 930 has an elongated body 932 that defines a pair of holes 934. 936 at one end 938 that slide rods 924 slidably, so that mounting element 930 can be slid along rods 924 in order to to position the tibial drill guide support 700 with respect to base plate 902. A spring loaded button 940 is arranged at the first end 938 of the mounting element 930 and is coupled to a locking mechanism (not shown) disposed within the mounting element 930 to lock the mounting element 930 in a position along the rods 924.
[0078] One or more holes 942 are defined at the second end 944 of the mounting element 930 and correspond to holes 716 of the drill guide holder 700 to couple the drill guide holder 700 to the foot support assembly 900. The second end 942 also defines a groove 946, · as best seen in figures 56 and 60, which is sized and configured to receive an internally threaded rod 948 from a pivoting arrangement 950 which includes a lower part 952 which is received within the groove 820 of the mounting plate 800 and is immobilized in a cross way through hole 814. The cross immobilization of pivoting arrangement 950 can pi vote around an axis defined by hole 814 and configured to receive a support clamping button 954. The bottom surface 956 (figure 60 ) of button 954 has an external dimension larger than slot 946 and is configured to engage mounting element 930 in order to secure the mounting plate assembly 800 es support for tibial drill guide 700, which can include the tibial drill cartridge 702.
[0079] In operation, the tibial drill guide support 700 is inserted into the resected joint space 22. The mounting plate 800 is connected to the tibial drill guide support 700 using dowels 70, as best seen in figures 49 and 50. With the arrangement pivot 950 cross-immobilized on the mounting plate 800, the mounting plate assembly 800 and pivoting arrangement 948 is coupled to the tibial drill guide holder with dowels 70, which can fit into the holes 822 of the mounting plate 800 and holes 716 of the tibial drill guide support 700, as will be understood by a person skilled in the art. The tibial drill guide support 700 and the mounting plate can be fixed inside the resected joint space 22 by inserting k wires (not shown) in the holes 736, 790 defined by the tibial drill guide support 700 and holes 830-1,830-2 (corresponding to holes 736-1, 736-2) and 832-1,832-2 defined by mounting plate 800.
[0080] With the mounting plate 800 coupled to the support for tibial drill guide 700 which is disposed within the resected articular space 22, the pivoting arrangement 948 is rotated so as to extend in a direction approximately parallel to the longitudinal axis defined by the patient's leg and the cartridge-style tibial bit guide 702 is inserted into opening 804 of the mounting plate 800 and recess 718 of the tibial bit guide holder 700. The tibial bit guide cartridge 702 is inserted until the front end 786 of the bit cartridge tibial 702 lean against the rear wall 788 of the tibial drill guide holder 700 at which point the spherical retention disposed within the hole 772 engages the hole 828 defined by the mounting plate 800 and the front side 768 of the tibial drill guide cartridge 702 is flush with the front side 806 of the mounting plate 700.
[0081] The holes 940 of the mounting element 930 are aligned and received in the pegs 70 that extend from the front side 806 of the mounting plate to couple the mounting element 930 of the foot support assembly 900 to the mounting plate assembly 800 , support for tibial drill guide 700 and tibial drill guide cartridge 702. With the mounting element 903 coupled to the pins 70 and mounting plate 800, the pivoting arrangement 948 is rotated relative to the mounting plate 800 so that the rod 946 of pivoting arrangement 948 is received into slot 944 of mounting element 930. Knob 952 is then rotated around its axis (clockwise or counterclockwise) so that the bottom surface 954 of knob 952 contacts the element mounting bracket 930 to maintain engagement between mounting element 930 and tibial drill guide support assembly 800 and mounting plate 800.
[0082] Drill chuck 912 is coupled to hole 910 in line with the heel of the patient's foot. As described above, drill chuck 912 can be slid into pocket 908 defined by bottom plate 902 until spring loaded retainers 916 releasably lock drill chuck 912 in place. In some embodiments, the drill chuck 912 can be threaded on the base plate 902 by means of corresponding threads arranged on an external surface of the drill chuck 912, which engage the threads defined by an internal surface of the pocket 908 and / or orifice 910. With drill chuck 912 in place, the patient's leg attached to the foot support set 900, various minimally invasive surgical techniques can be used to introduce a cannula into the sole of the foot in calcaneus 20, talus 14 and tibia 16, as described above.
[0083] As soon as access to the patient's calcaneus is achieved, a cannula is inserted into the sole of the foot 64 through the patient's calcaneus 20. A reamer 66 is operated through the cannula 64 to make another perforation through the talus 14 and upwards in the tibia 16 to establish an intramedullary guide path through the calcaneus 20 and talus 14 leading to the tibia 16. When the reamer 66 leaves the talus 14, the conical-shaped inner surface 748 guides the tip 68 into hole 788. An axis defined by hole 788 is aligned substantially axial to the mechanical axis of the tibia 16, so that when the reamer 66 is passed through the orifice 788, it punctures an intramedullary channel within the tibia 16.
[0084] The described system and method advantageously use surgical instruments, guides and / or fixation elements made especially based on the patient's anatomy to reduce the use of fluoroscopy during a surgical procedure. In some cases, the use of fluoroscopy during a surgical procedure can be eliminated completely. Specially made instruments, guides and / or fixation elements are created by images of the patient's anatomy made by computed tomography (“CT”), magnetic resonance imaging (“MRI”) or similar medical imaging technology before surgery and using these images to create instruments, guides and / or fastening elements specific to the patient.
[0085] Although the present invention has been described in terms of exemplary embodiments, it is not limited to them. On the contrary, the appended claims must be interpreted broadly to include other variants and embodiments of the present invention that can be performed by those skilled in the art without departing from the scope and reach of equivalents of the present invention.

权利要求:
Claims (11)
[0001]
SYSTEM FOR ESTABLISHING AN INTRAMEDULAR PATH (200) characterized by the fact that it comprises: a body (204) dimensioned and configured to be received within a resected bone space and defining a first opening (206) that extends through the body (204), the first opening (206) dimensioned and configured to receive a surgical instrument through of the same; and a first bone hitch structure (110) extending from the body (204) in a first direction, the first bone hitch structure (110) including a first surface (116) which is complementary to the topography of the surface of a first bone (16a), and a drill guide (202) dimensioned and configured to be received within the first opening (206) defined by the body (204), the drill guide (202) defining a second opening (246) dimensioned and configured to receive the surgical instrument through of the same. in which when the first surface (116) of the bone engaging structure (110) engages the topography of the surface of the first bone to which the first surface (116) is complementary, an axis defined by the first opening (206) is substantially collinear to the axis tibia (16a) wherein the first opening (206) includes a small diameter part (218) and an outer surface of the drill guide (202) includes a first part (218) which has a cross-sectional area less than a second part (240 ) and being dimensioned and configured to be received within the reduced diameter part of the first opening (206).
[0002]
SYSTEM, according to claim 1, characterized by the fact that the second bone hitch structure (112) extends from the body (204) in a direction that is substantially opposite to the first direction, the second bone hitch structure ( 112) including a second surface (114) that is complementary to the topography of the surface of a second bone (14a).
[0003]
SYSTEM according to claim 1, characterized in that an external surface of the drill guide (202) includes a flat surface (242) which is complementary to a non-rotating element disposed within the first opening (206).
[0004]
SYSTEM, according to claim 1, characterized by the fact that the second opening (240) tapers along at least part of its length.
[0005]
SYSTEM, according to claim 1, characterized by the fact that the body (204) defines at least one hole for coupling the body (204) to a coupling bar (400), the coupling body (204) configured to engage a pair of alignment rods (318) extending from a foot support assembly (302).
[0006]
SYSTEM FOR ESTABLISHING AN INTRAMEDULAR PATH characterized by the fact that it comprises: a drill guide holder (200) including a body (204) dimensioned and configured to be received within a resected bone space, the body (204) defining a first opening (206) extending through the body (204), a first bone engaging structure (110) extending from the body (204) in a first direction and including a first surface (116) which is complementary to the topography of the surface of a first bone (16a); and a drill guide (202) dimensioned and configured to be received within the first opening (206) defined by the body of the drill guide holder (200), the drill guide (202) defining a second opening (246) dimensioned and configured to receive the surgical instrument through it, in which when the first surface (116) of the bone engaging structure (110) engages the surface topography of the first bone (16a) to which the first surface (116) is complementary, an axis defined by the second opening (206) is substantially collinear to the tibial axis (16a), wherein the first opening (206) includes a small diameter part and an outer surface of the drill guide (202) includes a first part having a cross-sectional area smaller than a second part (240) and being dimensioned and configured to be received within the reduced diameter portion of the first opening (206) ..
[0007]
SYSTEM, according to claim 7, characterized by the fact that a second bone hitch structure (102) extends from the body of the drill guide holder (200) in a direction that is substantially opposite to the first direction, the second bony engagement structure (102) including a second surface (116) which is complementary to the topography of the surface of a second bone (14a).
[0008]
SYSTEM, according to claim 8, characterized by the fact that each of the first and second bone hitch structure (110, 102) includes at least one orifice (230, 236) dimensioned and configured to receive a k wire (62) through it.
[0009]
SYSTEM according to claim 7, characterized in that an external surface of the drill guide (202) includes a flat surface (242) which is complementary to a non-rotating element disposed within the first opening (206).
[0010]
SYSTEM, according to claim 7, characterized by the fact that the second opening (503) tapers along at least part of its length.
[0011]
SYSTEM, according to claim 7, characterized by the fact that it also comprises a coupling bar (400) dimensioned and configured to engage a pair of alignment rods (318) that extend from a support set for the foot (302), the drawbar (400) configured to be coupled to the body of the drill guide holder (200) to maintain a position of the drill guide holder (200) in relation to the foot support assembly (302 ).

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法律状态:
2017-07-25| B15I| Others concerning applications: loss of priority|

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2017-08-08| B08F| Application fees: application dismissed [chapter 8.6 patent gazette]|

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2017-10-17| B08G| Application fees: restoration [chapter 8.7 patent gazette]|

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2017-10-24| B12F| Appeal: other appeals|

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2018-01-16| B25G| Requested change of headquarter approved|Owner name: WRIGHT MEDICAL TECHNOLOGY, INC. (US) |

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2019-10-22| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-08-04| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|

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2021-01-19| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-03-23| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 20/12/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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