Patent ID: 12201371

DETAILED DESCRIPTION OF THE DRAWINGS

Although the concepts of the present disclosure are susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and will be described herein in detail. It should be understood, however, that there is no intent to limit the concepts of the present disclosure to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives consistent with the present disclosure and the appended claims.

References in the specification to “one embodiment,” “an embodiment,” “an illustrative embodiment,” etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may or may not necessarily include that particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. It should further be appreciated that although reference to a “preferred” component or feature may indicate the desirability of a particular component or feature with respect to an embodiment, the disclosure is not so limiting with respect to other embodiments, which may omit such a component or feature. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to implement such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described.

Additionally, it should be appreciated that items included in a list in the form of “at least one of A, B, and C” can mean (A); (B); (C); (A and B); (B and C); (A and C); or (A, B, and C). Similarly, items listed in the form of “at least one of A, B, or C” can mean (A); (B); (C); (A and B); (B and C); (A and C); or (A, B, and C). Further, with respect to the claims, the use of words and phrases such as “a,” “an,” “at least one,” and/or “at least one portion” should not be interpreted so as to be limiting to only one such element unless specifically stated to the contrary, and the use of phrases such as “at least a portion” and/or “a portion” should be interpreted as encompassing both embodiments including only a portion of such element and embodiments including the entirety of such element unless specifically stated to the contrary.

The disclosed embodiments may, in some cases, be implemented in hardware, firmware, software, or a combination thereof. The disclosed embodiments may also be implemented as instructions carried by or stored on one or more transitory or non-transitory machine-readable (e.g., computer-readable) storage medium, which may be read and executed by one or more processors. A machine-readable storage medium may be embodied as any storage device, mechanism, or other physical structure for storing or transmitting information in a form readable by a machine (e.g., a volatile or non-volatile memory, a media disc, or other media device).

In the drawings, some structural or method features may be shown in specific arrangements and/or orderings. However, it should be appreciated that such specific arrangements and/or orderings may not be required. Rather, in some embodiments, such features may be arranged in a different manner and/or order than shown in the illustrative figures. Additionally, the inclusion of a structural or method feature in a particular figure is not meant to imply that such feature is required in all embodiments and, in some embodiments, may not be included or may be combined with other features.

Referring now toFIG.1, in the illustrative embodiment, a system100for adaptive surgeon-specific surgical instrumentation includes a computing device102, a network104, and an instrumentation manufacturing system106. Further, as shown, the illustrative instrumentation manufacturing system106includes one or more servers108and fabrication machinery110.

As described in detail below, the system100allows the surgeon to design various features of the surgical instrumentation (e.g., tibial and femoral cutting guides) such that the resultant surgical instrumentation is tailored to the surgeon based, for example, on the surgeon's specific techniques and/or preferences. As such, the system100may provide the surgeon direct control (e.g., by virtue of surgeon input provided through a graphical user interface) over how the surgical instrumentation will function and interact with the surgeon. For example, in some embodiments, the surgeon may indicate whether one or more of the tibial paddles of a surgeon-specific tibial cutting guide will have a contact extension, which can affect how the surgeon interacts with the guide. As such, the surgeon's design choice may impute both a physical and functional change to the surgical instrumentation and/or procedure. Similarly, the surgeon may provide input regarding the profile/shape of a tibial cutting guide such as, for example, whether the cutting guide should have a streamlined profile (e.g., for a tibial cut first surgical technique) or a more traditional/bulky profile (e.g., for a distal cut first surgical technique).

It should be appreciated that the surgeon-specific surgical instrumentation designed by the surgeon using the system100enables greater flexibility without the added inventory or complexity. The system100may permit the surgeon to select the necessary surgical instruments in a “to-order” or “just-in-time” approach based on the surgeon's technique and preferences, patient data, and/or other relevant parameters. Further, the surgeon-specific surgical instrumentation may allow the surgical procedure to proceed more quickly with a reduced probability of infection, vascular damage, wear debris, and/or the need to recut. The surgeon-specific surgical instrumentation may reduce the likelihood of sub-optimal implant placement, which can reduce implant life and increase the risk of revision. Additionally, the surgeon-specific surgical instrumentation may also maximize the chances of preserving host bone and/or ensure that revision surgeries are performed more easily.

The computing device102may be embodied as any type of computing device capable of performing the functions described herein. For example, the computing device102may be embodied as a desktop computer, laptop computer, tablet computer, notebook, netbook, Ultrabook™, cellular phone, smartphone, wearable computing device, personal digital assistant, mobile Internet device, Internet of Things (IoT) device, server, router, switch, and/or any other computing/communication device capable of performing the functions described herein. As shown inFIG.1, the illustrative computing device102includes a processor150, an input/output (“I/O”) subsystem152, a memory154, a data storage156, a communication circuitry158, one or more I/O devices160, and one or more peripheral devices162. Of course, the computing device102may include other or additional components, such as those commonly found in a typical computing device (e.g., various input/output devices and/or other components), in other embodiments. Additionally, in some embodiments, one or more of the illustrative components may be incorporated in the processor150in some embodiments. Although a single computing device102is illustratively shown, it should be appreciated that one or more of the components of the computing device102described herein may be distributed across multiple computing devices. In other words, the techniques described herein may be employed by a computing system that includes one or more computing devices.

The processor150may be embodied as any type of processor capable of performing the functions described herein. For example, the processor150may be embodied as a single or multi-core processor(s), digital signal processor, microcontroller, or other processor or processing/controlling circuit. Similarly, the memory154may be embodied as any type of volatile or non-volatile memory or data storage capable of performing the functions described herein. In operation, the memory154may store various data and software used during operation of the computing device102, such as operating systems, applications, programs, libraries, and drivers. The memory154is communicatively coupled to the processor150via the I/O subsystem152, which may be embodied as circuitry and/or components to facilitate input/output operations with the processor150, the memory154, and other components of the computing device102. For example, the I/O subsystem152may be embodied as, or otherwise include, memory controller hubs, input/output control hubs, firmware devices, communication links (i.e., point-to-point links, bus links, wires, cables, light guides, printed circuit board traces, etc.) and/or other components and subsystems to facilitate the input/output operations. In some embodiments, the I/O subsystem152may form a portion of a system-on-a-chip (SoC) and be incorporated, along with the processor150, the memory154, and other components of the computing device102, on a single integrated circuit chip.

The data storage156may be embodied as any type of device or devices configured for short-term or long-term storage of data such as, for example, memory devices and circuits, memory cards, hard disk drives, solid-state drives, or other data storage devices. The data storage156and/or the memory154may store various data during operation of the computing device102useful for performing the functions described herein.

The communication circuitry158may be embodied as any communication circuit, device, or collection thereof, capable of enabling communications between the computing device102and other remote devices (e.g., the instrumentation manufacturing system106, the server108, etc.) over a network (e.g., the network104). The communication circuitry158may be configured to use any one or more communication technologies (e.g., wireless or wired communications) and associated protocols (e.g., Ethernet, Bluetooth®, WiMAX, etc.) to effect such communication.

The I/O devices160may include any number of devices configured to receive input data from a surgeon and/or other user (i.e., input devices) and any number of devices configured to output data to the surgeon and/or other user (i.e., output devices). The particular devices included in the I/O devices160may depend on, for example, the type and/or intended use of the computing device102. For example, in some embodiments, the I/O devices160may include a display device on which a graphical user interface (see, e.g., the graphical user interface300ofFIGS.3-4) can be displayed for the surgeon. Further, the I/O devices160may include an input device that allows the surgeon to select various options presented on the graphical user interface. For example, in some embodiments, the input device may be embodied as a keyboard, mouse, touchscreen display, and/or microphone. In particular, in some embodiments, it should be appreciated that the computing device102may be embodied as a tablet computer, smartphone, or other computing device having a touchscreen display that serves to both receive input from the surgeon/user and provide output to the surgeon/user.

The peripheral devices162may include any number of additional peripheral or interface devices, such as speakers, microphones, additional storage devices, and so forth. The particular devices included in the peripheral devices162may depend on, for example, the type and/or intended use of the computing device102. For example, in some embodiments, the peripheral devices162may include a keyboard, mouse, display, touchscreen display, printer, alarm, status indicator, handheld device, diagnostic tool, and/or one or more other suitable peripheral devices.

It should be appreciated that one or more software applications may be executed by the processor150to display the graphical user interface (e.g., the graphical user interface300ofFIGS.3-4) on the I/O device(s)160and receive the relevant surgeon input regarding the desired parameters of the surgeon-specific surgical instrumentation. The application(s) may be embodied as any suitable application(s) for performing the functions described herein. For example, depending on the particular embodiment, the application may be embodied as a mobile application (e.g., a smartphone application), a cloud-based application, a web application, a thin-client application, and/or another suitable type of application. In some embodiments, the application may serve as a client-side user interface (e.g., via a web browser) for a web-based application or service (e.g., of the server(s)108).

The network104may be embodied as any type of communication network capable of facilitating communication between the computing device102and remote devices (e.g., the instrumentation manufacturing system106, the server(s)108, etc.). As such, the network104may include one or more networks, routers, switches, computers, and/or other intervening devices. For example, the network104may be embodied as or otherwise include one or more cellular networks, telephone networks, local or wide area networks, publicly available global networks (e.g., the Internet), ad hoc networks, short-range communication links, or a combination thereof.

The instrumentation manufacturing system106may be embodied as any collection of one or more devices, components, and/or systems configured to perform the functions described herein. As shown, the illustrative instrumentation manufacturing system106includes one or more servers108and fabrication machinery110. However, it should be appreciated that the instrumentation manufacturing system106may include additional and/or alternative devices, components, and/or systems in other embodiments. Similarly, one or more of the devices, components, and/or systems of the instrumentation manufacturing system106described herein may be omitted in other embodiments. Depending on the particular embodiment, the various devices, components, and/or systems of the instrumentation manufacturing system106may be co-located, or may be distributed across various locations.

Each of the one or more servers108may be embodied as any type of computing device capable of performing the functions described herein. For example, each server108may be embodied as a server, desktop computer, laptop computer, tablet computer, notebook, netbook, Ultrabook™, cellular phone, smartphone, wearable computing device, personal digital assistant, mobile Internet device, Internet of Things (IoT) device, router, switch, and/or any other computing/communication device capable of performing the functions described herein. In some embodiments, one or more of the servers108may be similar to the computing device102described above. As such, the components of the server(s)108may be similar to the components of the computing device102described above and, therefore, the descriptions have not been repeated herein for clarity of the description. Further, it should be appreciated that the server(s)108may include other components, sub-components, and/or devices commonly found in a computing device, which are not discussed herein for clarity of the description. Additionally, in some embodiments, one or more of the components of the computing device102may be omitted from one or more of the servers108(e.g., the peripheral devices162). It should be appreciated that, although the server(s)108are described herein as one or more computing devices outside of a cloud computing environment, in other embodiments, the server(s)108may be embodied as a cloud-based device or collection of devices.

The fabrication machinery110may be embodied as any type of machinery capable of manufacturing/fabricating the surgeon-specific surgical instrumentation and otherwise performing the functions described herein. In some embodiments, it should be appreciated that the surgeon-specific surgical instruments may be fabricated on an “as requested” and/or “just-in-time” basis based on the surgeon input. Further, in some embodiments, the surgeon-specific surgical instruments may also be patient-specific (e.g., having contours adapted to match the contours of the patient's bony anatomy). However, in some embodiments, there may be a finite number of possible surgeon-specific surgical instruments based on a finite number of possible combinations of surgeon input data via the graphical user interface. In such embodiments, every possible adaptive surgeon-specific surgical instrument may be manufactured and stored (e.g., by the manufacturer and/or at a remote inventory facility). For example, the surgeon-specific tibial cutting guides corresponding with every possible combination of adaptive tibial guide parameters and/or the surgeon-specific femoral cutting guides corresponding with every possible combination of adaptive femoral guide parameters may be manufactured and stored. In yet another embodiment, the more common surgical instruments may be stored and the less common surgeon-specific surgical instruments may be manufactured on an “as requested” basis.

Although only one computing device102, one network104, and one instrumentation manufacturing system106are shown in the illustrative embodiment ofFIG.1, the system100may include multiple computing device102, multiple networks104, and/or multiple instrumentation manufacturing systems106in other embodiments.

Referring now toFIG.2, in use, the system100may execute a method200for identifying surgeon-specific surgical instrumentation based on surgeon input. It should be appreciated that the particular blocks of the method200are illustrated by way of example, and such blocks may be combined or divided, added or removed, and/or reordered in whole or in part depending on the particular embodiment, unless stated to the contrary. The illustrative method200begins with block202in which the computing device102prompts the surgeon/user for patient and surgical parameters via a graphical user interface (e.g., presented on a display device). In particular, in block204, the computing device102may prompt the surgeon/user for patient information and surgeon information (e.g., surgeon-identifying information). For example, the patient information may include patient-identifying information (e.g., name, unique identifier, birthdate, etc.), relevant patient/surgical parameters (e.g., prospective implant type, manufacturer, model, etc.), anthropometric data, image data (e.g., x-ray images, MM images, CT images, ultrasound images, and/or other suitable bone images), and/or other relevant patient information. In some embodiments, instead of prompting the surgeon/user for such data, a portion (or the entirety) of the patient information and surgeon information may be received from another computing device or retrieved from the memory154or data storage156of the computing device102.

As indicated above, it should be appreciated that the surgeon may provide input regarding the surgeon's technique and/or preferences with respect to a prospective surgery (e.g., a total knee replacement surgery). In particular, the surgeon may provide various design parameters associated with the physical structure of the relevant surgical instruments. As such, in block206, the computing device102may prompt the surgeon for adaptive tibial guide parameters, which may be collectively indicative of the physical structure of the surgeon-specific tibial cutting guide to be used by the surgeon (see, for example, the graphical user interface300as depicted inFIG.3). Further, in block208, the computing device102may prompt the surgeon for adaptive femoral guide parameters, which may be collectively indicative of the physical structure of the surgeon-specific femoral cutting guide to be used by the surgeon (see, for example, the graphical user interface300as depicted inFIG.4). Although the surgeon-specific surgical instrumentation is described herein in reference to the surgeon-specific tibial cutting guide and the surgeon-specific femoral cutting guide, it should be appreciated that the techniques may be applied to other surgical instruments in other embodiments.

In block210, the computing device102receives the surgeon input (e.g., via the graphical user interface and/or the I/O device160) associated with the relevant design parameters for the surgical instrumentation. In particular, in the illustrative embodiment, the computing device102receives the surgeon input associated with the adaptive tibial guide parameters and the adaptive femoral guide parameters.

In some embodiments, in block212, the computing device102may validate the surgeon input. For example, in some embodiments, the computing device102may confirm that the surgeon input for a particular design parameter is acceptable (e.g., a value selected from a predefined set of options, a value within acceptable design thresholds, etc.) depending on the particular circumstances. Further, in some embodiments, the computing device102may confirm that the surgeon input (e.g., the adaptive tibial/femoral guide parameters) is consistent with the anatomy of the patient. For example, in some embodiments, the computing device102may only allow a tibial paddle to interfere with the cut plane if the patient's proximal tibia is significantly damaged.

In block214, the computing device102transmits the received (and, in some embodiments, validated) surgeon input to the instrumentation manufacturing system106. In particular, in some embodiments, the surgeon input may be transmitted to one or more of the servers108.

In block216, the surgeon-specific surgical instrumentation is fabricated using the fabrication machinery110of the instrumentation manufacturing system106based on the surgeon input. In particular, in the illustrative embodiment, the fabrication machinery110may be used to fabricate a surgeon-specific tibial cutting guide based on the adaptive tibial guide parameters provided by the surgeon and/or a surgeon-specific femoral cutting guide based on the adaptive femoral guide parameters provided by the surgeon. As described above, in some embodiments, the surgeon-specific surgical instrumentation may be fabricated according to a “to order” or “just-in-time” approach, whereas in other embodiments, the surgeon-specific surgical instrumentation may be prefabricated and selected to correspond with the parameters provided in the surgeon input.

Although the blocks202-216are described in a relatively serial manner, it should be appreciated that various blocks of the method200may be performed in parallel in some embodiments.

Referring now toFIGS.3and4, as indicated above, the computing device102may utilize a graphical user interface300to convey information to the surgeon, prompt the surgeon for input, and/or to receive surgeon input. As shown, the graphical user interface300identifies numerous categories of design parameters associated with a surgeon-specific tibial cutting guide and a surgeon-specific femoral cutting guide and prompts the surgeon for the associated inputs and selections. In particular, in the illustrative embodiment, the graphical user interface300includes a tibia tab302that, when selected/activated as shown inFIG.3, prompts the surgeon for associated inputs for various adaptive tibial guide parameters. The graphical user interface300also includes a femur tab304that, when selected/activated as shown inFIG.4, prompts the surgeon for associated inputs for various adaptive femoral guide parameters. Although each of the adaptive tibial and femoral guide parameters is shown as a selection of discrete options in the illustrative graphical user interface300, in other embodiments, a graphical user interface may otherwise prompt the surgeon for parameter inputs (e.g., via an alphanumeric input field). For example, in an embodiment, the graphical user interface may permit the surgeon to enter a blade thickness (or length) in millimeters, micrometers, and/or other suitable unit of measure, which may be validated as described above.

As described herein, it should be appreciated that the various adaptive tibial and femoral guide parameters selected by the surgeon may affect the physical structure and function of the corresponding surgeon-specific cutting guides. Although specific adaptive tibial and femoral guide parameters (and options thereof) are described in reference to the graphical user interface300, it should be appreciated that the graphical user interface300may include other adaptive tibial guide parameters, other adaptive femoral guide parameters, other options for the adaptive tibial guide parameters, and/or other options for the adaptive femoral guide parameters in addition to or in the alternative to the parameters and options described herein by way of example. For example, in some embodiments, the graphical user interface300may prompt the surgeon for an indication of the size of the pinholes, the length of the pins, and/or the depth at which the pins can be driven.

As shown inFIG.3, when the tibia tab302is active, the illustrative graphical user interface300prompts the surgeon to select a surgical sequence306(viz., distal cut first (DCF) or tibial cut first (TCF)), whether the surgeon-specific tibial cutting guide includes contact extensions308and whether the contact extensions are separable310, whether the surgeon-specific tibial cutting guide has proximal contact below the cut plane312, whether the surgeon-specific tibial cutting guide has a bicruciate sparing feature314, a preferred tibial recut guide316(viz., GENESIS™ II MIS, GENESIS™ II TAA, JOURNEY™ II MIS, or TC-PLUS™ TAA), a cutting blade thickness318(viz., 1.35 mm or 1.27 mm), an alignment rod preference320(viz., perpendicular to cut or parallel to tibia), and whether the surgeon-specific tibial cutting guide has rimmed pinholes322. As shown inFIG.4, when the femur tab304is active, the graphical user interface300prompts the surgeon to select whether the surgeon-specific femoral cutting guide includes contact extensions330and whether the contact extensions are separable332, whether the surgeon-specific femoral cutting guide has distal contact above the cut plane334, a preferred femoral recut guide336(viz., GENESIS™ II, JOURNEY™, or TC-PLUS™), a cutting blade thickness338(viz., 1.35 mm or 1.27 mm), and whether the surgeon-specific femoral cutting guide has rimmed pinholes340. Although the illustrative graphical user interface300specifically identifies various GENESIS™ JOURNEY™ and TC-PLUS™ recut guides, it should be appreciated that, in other embodiments, recut guides having similar features to those guides may be identified (e.g., by name or by prevalent feature(s)) as options. Further, in other embodiments, the graphical user interface300may identify for selection one or more other recut guides suitable for performing the functions described herein (e.g., recut guides manufactured by Smith & Nephew®, Zimmer Biomet, Stryker, DePuy Orthopaedics, and/or another manufacturer). Various structural and/or functional implications of the graphical user interface300selections indicated above are described in further detail below.

Referring now toFIGS.5-7, the surgeon may select a distal cut first (DCF) surgical technique or a tibial cut first (TCF) surgical technique.FIG.5depicts various features of a surgeon-specific tibial cutting guide500used with a DCF technique, whereasFIGS.6-7depict various features of the guide500used with a TCF technique.FIG.6shows the guide500with the knee joint in flexion, andFIG.7shows the guide500with the knee joint in extension. It should be appreciated that DCF is a surgical technique in which the distal femur502is cut first to open the joint space for more visibility and maneuverability, whereas TCF is a surgical technique in which the proximal tibia504is cut first to provide a foundation for subsequent cuts and measurements and/or to simplify balancing of the amount of bone removed from the femur, which is nontrivial due, for example, to kinematics and soft tissue factors.

As shown inFIG.5, if the DCF technique is used, the pinholes506on the tibial paddles508of the surgeon-specific tibial cutting guide500may be angled vertically (e.g., perpendicular to a proximal surfaces510of the paddles508), because the pinholes506will not interfere with the already-resected femur. However, with the TCF technique, there is limited joint space within which to operate. Accordingly, as shown inFIGS.6-7, if the TCF technique is used, the profile of the surgeon-specific tibial cutting guide500is lower/thinner. In particular, the transition511of the tibial paddles508to the thinner tibial contact portion513may occur more anteriorly with the TCF technique than with the DCF technique, which may result in a higher proportion of the thinner tibial contact portion513length relative to the overall anterior-posterior dimension of the guide500. As such, in some embodiments, the TCF-designed guide may have less posterior thickness than a DCF-designed guide. Further, in some embodiments, selecting the TCF technique may cause the pinholes506to be shifted anteriorly and/or angled anteriorly relative to the proximal surfaces510of the paddles508. In some embodiments, a thickness512of the tibial paddles508used with the TCF technique may be less than a standard thickness514as used with the DCF technique. In other embodiments, it should be appreciated that the surgeon may include design parameters such that the guide500is a low profile (thin) guide and/or has angled/shifted pinholes506even when a DCF technique is employed.

Referring now toFIGS.8-11, the surgeon may indicate that one or both of the tibial paddles508of the surgeon-specific tibial cutting guide500is to include a contact extension516and/or that one or both of the femoral paddles602of the surgeon-specific femoral cutting guide600is to include a contact extension604. It should be appreciated that the surgeon may select to include the contact extension(s)516and/or the contact extension(s)604if the surgeon prefers more contact area with the proximal tibia504or the distal femur502, respectively, whereas the surgeon may omit the contact extension(s)516and/or the contact extension(s)604if the surgeon prefers more visibility in the joint space.

FIG.8depicts the surgeon-specific tibial cutting guide500without contact extensions516, whereasFIG.9depicts the guide500with one contact extension516.FIG.10depicts the surgeon-specific femoral cutting guide600without contact extensions604, whereasFIG.11depicts the guide600with both contact extensions604. Further, as described above and illustrated inFIG.12, the surgeon may select whether each of the contact extension(s)516and/or the contact extension(s)604is separable from a remainder518,606of the corresponding paddle508,602. It should be appreciated that each of the contact extensions516may be structured to be separable from the remainder518of the corresponding tibial paddle508according to any suitable technique. For example, in some embodiments, the contact extension516may have a perforation520or area of weakened volume/density to allow the surgeon to separate the contact extension516from the remainder518of the tibial paddle508with less force than would otherwise be required. Similarly, it should be appreciated that each of the contact extensions604may be structured to be separable from the remainder606of the corresponding femoral paddle602according to any suitable technique.

Referring now toFIGS.13-18, in the illustrative graphical user interface300, the surgeon may provide input regarding whether the tibial paddle(s)508should extend below the cut plane522of a cutting blade of a cutting instrument, which may result in at least temporary interference with the blade. As shown inFIG.13, the surgeon may encounter a patient whose proximal tibia504is severely damaged or deformed. For example, one of the tibial articular surfaces may be worn down so much that the cutting blade could cut through one of the tibial paddles508. As such, it may be advantageous to have a surgeon-specific tibial cutting guide500designed to extend below (i.e., distal to) the cut plane522to contact the proximal tibia504for support prior to pinning the guide500. Accordingly, as shown inFIGS.16-18, the surgeon-specific tibial cutting guide500may include a contact extension524that extends distally from the corresponding tibial paddle508and having a distal surface526that contacts the proximal tibia504for support thereon. Similar to the contact extensions516,604described above, in some embodiments, the contact extension524may be separable from a remainder528of the tibial paddle508according to any suitable technique (e.g., perforations, weakened volume/density, etc.). For example, in some embodiments, the surgeon may utilize a surgeon-specific tibial cutting guide500having one or more contact extensions524to support the guide500while it is being stabilized and pinned to the tibia, and subsequently separate/remove the contact extension(s)524from the guide500prior to using the cutting blade. As shown inFIGS.14and15, in other embodiments, neither of the tibial paddles508of the surgeon-specific tibial cutting guide500extends below (distal to) the cutting plane522. As indicated above, it should be appreciated that the surgeon-specific cutting guides500,600may also be patient-specific in some embodiments. As shown inFIG.4, the surgeon may similarly provide input regarding whether the femoral paddle(s)602should extend above the corresponding cut plane to contact, for example, a severely damaged distal femur502.

Referring now toFIGS.19and20, the surgeon may provide input regarding whether the surgeon-specific tibial cutting guide500should include one or more bicruciate ligament sparing features. For example, when the surgeon views the patient's bone images (e.g., x-ray images, MRI images, CT images, ultrasound images, and/or other suitable bone images), the surgeon may recognize that the cruciate ligaments are viable and may opt to design the surgeon-specific tibial cutting guide500to be more “anatomically friendly.” Further, in some embodiments, one or more of those features may include the ability to place additional pins and/or marks on the patient's bone based on, for example, pre-operative imaging of the bone. In some embodiments, rotation, varus-valgus, depth, or all six degrees of freedom can be set using the designed guide500. As shown inFIG.19, the surgeon-specific tibial cutting guide500may include visual indicators530that assist in positioning the guide500, additional anterior pinholes532that may be used as locators for a subsequent surgical cutting guide, and/or additional anterior pinhole534that may provide a hard stop for a proposed cut and/or serve as an alignment feature for subsequent surgical cutting guides. In some embodiments, based on the surgeon input, the surgeon-specific tibial cutting guide500may include one or more features of the guide1200described below with reference toFIGS.45-50.FIG.20depicts the surgeon-specific tibial cutting guide500without the bicruciate ligament sparing features described herein.

It should be appreciated that the surgeon-specific tibial cutting guide500and the surgeon-specific femoral cutting guide600may be designed based on the surgeon input to be used in conjunction with whichever surgical support instrumentation the surgeon prefers (e.g., standard surgical recut guides). In particular, the guides500,600may be designed to cooperate with whichever tibial recut guide and/or femoral recut guide the surgeon prefers. As shown inFIGS.38and39, in operation, the surgeon-specific tibial cutting guide500may be secured to the patient's tibia by two anterior pins536driven into anterior pinholes538(see alsoFIG.5) of the guide500and, after resection of the proximal tibia504using the cutting blade544and removal of the guide500, the pins536remain inserted into the tibia. Accordingly, in the illustrative embodiment, the surgeon-specific tibial cutting guide500may be designed such that the anterior pinholes538position the pins536in the proper locations such that the pins536can be inserted into corresponding recut guide pinholes540to secure the recut guide to the patient's already-resected tibia. Similarly, as shown inFIGS.40and41, in operation, the surgeon-specific femoral cutting guide600may be secured to the patient's femur by two anterior pins546driven into anterior pinholes548of the guide600and, after resection of the distal femur502using the cutting blade544and removal of the guide600, the pins546remain inserted into the femur. Accordingly, in the illustrative embodiment, the surgeon-specific femoral cutting guide600may be designed such that the anterior pinholes548position the pins546in the proper locations such that the pins546can be inserted into corresponding recut guide pinholes550to secure the recut guide to the patient's already-resected femur.

As indicated above, the illustrative graphical user interface300provides the surgeon with the GENESIS™ II MIS tibial recut guide700(seeFIGS.21A and21B), GENESIS™ II TAA tibial recut guide702(seeFIGS.24A and24B), JOURNEY™ II MIS tibial recut guide704(seeFIGS.25A and25B), and TC-PLUS™ TAA tibial recut guide706(seeFIGS.23A and23B) as options for the surgeon's preferred tibial recut guide. However, as described above, it should be appreciated that the graphical user interface300may present additional and/or alternative tibial recut guides in other embodiments. For example, the surgeon may further select from the JOURNEY™ MIS tibial recut guide708(seeFIGS.22A and22B), the JOURNEY II XR™ tibial recut guide710(seeFIGS.26A and26B), and/or other suitable tibial recut guides. It should be appreciated that each of the tibial recut guides700-710includes multiple sets of recut guide pinholes540, which may be used to adjust the height and/or offset of the corresponding tibial recut guide relative to the resected tibial surface542.

The illustrative graphical user interface300further provides the surgeon with the GENESIS™ II femoral recut guide800(seeFIGS.27A and27B), JOURNEY™ femoral recut guide802(seeFIGS.28A and28B), and the TC-PLUS™ femoral recut guide804as options for the surgeon's preferred femoral recut guide. However, as described above, it should be appreciated that the graphical user interface300may present additional and/or alternative femoral recut guides in other embodiments. It should be appreciated that each of the tibial recut guides800-804includes multiple sets of recut guide pinholes550, which may be used to adjust the height and/or offset of the corresponding femoral recut guide relative to the resected femoral surface552.

In some embodiments, it should be appreciated that the surgeon-specific tibial cutting guide500and/or the surgeon-specific femoral cutting guide600may have recut pinning modularity similar to the blocks2100,2102described below with reference toFIGS.51-59.

As described above, the surgeon input may include a thickness of the cutting blade544of a cutting instrument that the surgeon prefers or intends to use for the surgical procedure. For example, it should be appreciated that there is a tradeoff between the amount of vibration of the cutting blade544and its ease of use. That is, thicker cutting blades544tend to vibrate less but require more effort to use, whereas thinner cutting blades544vibrate more but require less effort to use. In the illustrative embodiment, the cutting slot of the surgeon-specific tibial guide500,600is designed to harmonize with the surgeon's preferred cutting blade thickness. For example, using a thick blade in a thin slot can generate debris that is harmful to the patient. In some embodiments, it should be appreciated that the surgeon may select a cutting blade544for use with the surgeon-specific tibial cutting guide500with a different thickness than that selected for use with the surgeon-specific femoral cutting guide600.

Referring now toFIGS.30and31, the surgeon may indicate (via the graphical user interface300) an alignment rod preference for the surgical procedure. In particular, the surgeon may indicate whether the surgeon-specific tibial cutting guide500should be designed for use with the surgical technique illustrated inFIG.30in which an alignment rod900is aligned parallel to a mechanical axis902of the patient's tibia to gauge alignment, or the surgeon-specific tibial cutting guide500should be designed for use with the surgical technique illustrated inFIG.31, in which the alignment rod900is aligned perpendicular to the cutting slot554of the guide500. It should be appreciated that standard surgical instrumentation for many knee systems includes a built-in 3° to 10° posterior slope. As such, the parallel alignment technique described in reference toFIG.30allows the surgeon to perform the identical technique (i.e., ensure parallelism) regardless of the specific built-in posterior slope of the guide500. However, if the surgeon desires more control over the posterior slope of the guide500, the surgeon may opt for the perpendicular alignment technique described in reference toFIG.31, which provides a reliable benchmark for the surgeon. In some embodiments, the surgeon-specific tibial cutting guide500may include a visual indicator556(e.g., marking, engraving, etc.) of the alignment technique for which the guide500is designed.

Referring now toFIGS.32and33, the surgeon may indicate whether the tibial paddles508of the surgeon-specific tibial cutting guide500are to include rimmed pinholes558. It should be appreciated that headed pins, for example, may be overdriven below the surface of the paddle508such that it is difficult to retrieve the pin. Carving out or otherwise extracting a deeply seated pin increases surgical time and may cause vascular damage and/or infection to the patient. As such, the surgeon may opt for a guide500with rimmed pinholes558to facilitate removal of overdriven pins as described below. However, the surgeon may not necessarily use headed pins and/or may find rimmed pinholes558uncomfortable to grip, in which case the surgeon may opt for a guide500with non-rimmed pinholes560(i.e., without rimmed pinholes).FIG.32depicts the surgeon-specific tibial cutting guide500with rimmed pinholes558.FIG.33depicts the surgeon-specific tibial cutting guide500with non-rimmed pinholes560.

Referring now toFIGS.34and35, the surgeon may further indicate whether the femoral paddles602of the surgeon-specific femoral cutting guide600are to include rimmed pinholes558or non-rimmed pinholes560.FIG.34depicts the surgeon-specific femoral cutting guide600with rimmed pinholes558.FIG.35depicts the surgeon-specific femoral cutting guide600with non-rimmed pinholes560. Although the non-rimmed pin-holes560of the surgeon-specific femoral cutting guide600are illustrated as having bosses562extending from the femoral paddles602, it should be appreciated that the bosses562may be omitted such that the non-rimmed pinholes560terminate at the distal surface of the femoral paddles602in other embodiments (i.e., such that the non-rimmed pinholes560are flush with the femoral paddles602). Likewise, in some embodiments, the non-rimmed pinholes560of the surgeon-specific tibial cutting guide500may include bosses similar to the bosses562in some embodiments.

FIGS.36and37illustrate a rimmed portion564(e.g., a capture portion) of a rimmed pinhole558being removed to allow a surgeon to gain access to an overdriven pin566. In particular, the rimmed pinhole558may generally include a boss portion568and the rimmed portion564. Further, the rimmed portion564may be coupled to the boss portion568by a neck portion570that is sized to provide an undercut between the boss portion568and the rimmed portion564. As depicted inFIG.37, the recess or undercut provided by the neck portion570may be sized to receive a tool such as, for example, a rongeur to extract the rimmed portion564. For example, the tool may be used to apply a force (e.g., a pulling or twisting force) to the rimmed portion564to separate the rimmed portion564from the boss portion568, thereby gaining access to the overdriven pin566for removal thereof.

FIG.42illustrates a medial side view of an exemplary tibial cutting block1100operably secured via one or more pins1102to a proximal end1104of a tibia1106.FIG.42also depicts a portion of a tibial eminence1108at the proximal end1104of the tibia1106. For at least some patients that undergo a knee implant procedure, the anterior and posterior cruciate ligaments may still be attached to the tibial eminence1108. Thus, for at least some knee implant procedures, such as procedures in which the attachments of the anterior and posterior cruciate ligaments to the tibial eminence1108are intact, the exemplary tibial cutting block1100can be configured to at least assist in attempts to retain the tibial eminence1108and the associated attachments, while other generally adjacent portions of bone at the proximal end1104of the tibia1106is resected. Conversely, according to other procedures, including, for example, procedures in which the anterior and posterior cruciate ligaments are damage, the tibial cutting block1100can be configured the remove tibial eminence1108, as well as the attached ligaments and adjacent bone, via resection of at least a portion of the proximal end1104of the tibia1106.

The exemplary tibial cutting block1100depicted inFIG.42can include an anterior tibial portion1110, a medial tibial paddle1112, and a lateral tibial paddle (not shown). The anterior tibial portion1110can be configured to overly a portion of the anterior face1114of the tibia1106. The medial tibial paddle1112can be configured to overly at least a portion of the medial plateau, while the lateral tibial paddle, which can have a configuration that is generally similar to that of the medial tibial paddle1112, can be configured to overly at least portions of the lateral plateau of the tibia1106. Further, although not illustrated, the anterior tibial portion1110, medial tibial paddle1112and lateral tibial paddle of the tibial cutting block1100can include bone interfacing surfaces that are configured to interact with opposing portions of the proximal end1104of the tibia1106, and/or interact with or otherwise accommodate associated cartilage at or around the tibia1106.

The tibial cutting block1100can also include a cutting slot1116that is that is sized to receive insertion of a cutting blade that can cut or resect the tibia1106. According to the illustrated embodiment, the cutting slot1116is oriented on the medial half of the anterior side of the tibial cutting block1100. The cutting slot1116can be formed through the bone interfacing portions of the tibial cutting block1100, or may be recessed from the bone interfacing surfaces. The thickness of the cutting slot1116can help direct the orientation of the cutting tool, such as, for example, a saw blade, as the cutting tool advances through the cutting slot1116. Further, the translation of the cutting slot1116relative to the tibial cutting block1100, can, according to at least certain cutting blocks, at least assist in setting a resection depth.

The tibial cutting block1100can include a plurality of pin holes1118that can each be configured to receive pins1102that are inserted and/or driven into a portion of the tibia1106. At least some of the pin holes1120can receive pins1118that can be used to at least secure the tibial cutting block1100to the tibia1106, while other pins1120that extend through the tibial cutting block1100can also, or alternatively, be used in connection with aligning a component of the implant system that will be implanted in the patient.

According to at least certain types of implant procedures, preparation of the bone for an implant component may involve cutting a portion of the bone. For example, as discussed above, the exemplary tibial cutting block1100can be positioned such that at least a portion of the bone is removed via operation of the cutting instrument in the cutting slot1116. Further, the cutting slot1116may be positioned so that the cutting instrument is anticipated to cut the bone along a selected first cutting line (as indicated by “CL1” inFIG.42). Thus, when the cut bone is removed, a resected bone surface at of the tibia1106generally adjacent to, or directly beneath the first cut line, may be provide at, and/or across, the proximal end1104of the tibia1106.

The shape and/or size of the tibia1106, among other bones, is generally not uniform. Further, with respect to the tibia1106for example, the size and/or shape of the tibia1106can vary in a non-uniform manner along at least the mechanical axis of the tibia1106in the distal-proximal direction. For at least certain patients and/or for at least certain bones, such lack of uniformity and associated variance in the size and/or shape of the tibia1106can, traditionally, result in a degree of unpredictability in at least the size and/or shape of the bone that remains at a cut or resected surface of the tibia1106. Thus, for example,FIG.42illustrates a second cutting line (as indicated by “CL2” inFIG.42) that is linearly offset from the first cutting line CL1such that the second cutting line CL2is at a different cutting depth relative to the linear location of the first cutting line CL1about the proximal end1104of the tibia1106.

In view of the non-uniformity in the shape and/or size of the tibia1106, setting the cutting slot1116of the tibial cutting block1100at the second cutting line CL2could result in at least the resulting resected bone surface of the tibia1106, and/or the remaining portion of the tibia1106around the cut or resected bone surface, having a different shape and/or size than the cut or resected bone surface that can result from cutting or resecting the tibia along the first cutting line CL1. Further, the nature of the non-uniform variations in the shape and/or size of the bone, in this example the tibia1106, can result in a degree of unpredictability as to the extent of the differences in the size and/or shape of the bone surface that will result from cutting or resecting the tibia1106along the first or second cut lines CL1, CL2, among other possible bone cut locations.

Such potential differences in the resulting size and/or shape of the tibia1106after the tibia1106is cut or resected can, in at least certain circumstances, not be realized or otherwise known until after such cutting of the tibia1106has commenced or concluded. Additionally, such discovery of an unanticipated size and/or shape of the resulting cut or resected bone surface also can, in at least some instances, coincide with the unanticipated variation in the actual location of the tibial eminence1108. For example,FIG.43illustrates a medial side perspective view of an exemplary bi-cruciate retaining tibial tray1122positioned on a resected bone surface1120at a proximal end1104of the tibia1106. As shown in the depicted example, the anticipated size and/or shape of the resected bone surface1120, such as, for example, the size and/or shape of the resected bone surface1120around the proximal tibia periphery1124, can be different from the actual shape and/or size that remains after bony resection. However, again, those differences may remain unknown until after the bony resection has commenced or concluded. Thus, in the example depicted inFIG.43, an unexpected difference in the size and/or shape of the resected bone surface1120can result in compromised tray coverage. For example, such an unexpected variance in the size and/or shape of the tibia1106at the resected bone surface1120can result in the under-hanging of the bi-cruciate retaining tibial tray1122at least about a portion of the proximal tibia periphery1124, which can result in the absence of contact between the tibial tray1122and the cortical rim along at least a portion of the cortical rim.

FIG.44illustrates a schematic flow diagram of an exemplary process1300for preoperative planning that includes virtual visualization and analysis for bone preparation and orthopedic implant design and positioning. As noted above, the blocks illustrated for the processes in the present application are understood to be examples only, and blocks can be combined or divided, and added or removed, as well as re-ordered in whole or in part, unless explicitly stated to the contrary. Further, while the below exemplary process is discussed with respect to preparation of a tibia and associated ligaments, the below discussed process is also applicable to a variety of other bones, ligaments, and/or implant procedures, including, but not limited to implant procedures, and any associated bone resection, involving hips, shoulders, and ankles, among other joints and associated bones. Further, the bone referred to herein may be a bone of a human or of an animal.

At block1302, one or more images of at least the bone(s) that is/are to be resected are obtained. Such images can be obtained using a variety of different imaging sources or technology, including, for example, magnetic resonance imaging (MRI), X-ray(s), computerized tomography (CT) scans, ultrasounds, two and/or three-dimensional cameras, among other imaging sources, systems, or technology that can take images or otherwise provide information regarding the size and/or shape of the bone. For example, one or more images obtained at block1302can, according to certain embodiments, be of at least the proximal end1104of the tibia1106of a particular patient who will be undergoing a knee implant procedure. Additionally, while block1302is discussed with reference to obtaining images, the information obtained at block1302may also, or alternatively, include information from anthropometrics of the patient prior to surgery using, for example, motion capture, force plate data, stair climb data, stair descend data, and/or chair rise data, among other types of data. Further, the imaging can also include obtaining at least certain measurements of the bone and/or patient, including, for example, anatomic measurements and/or biomechanic measurements.

At block1304, the images obtained at block1302can be used to generate a two-dimensional and/or three-dimensional computer model(s) of the bone(s), such as, for example, a two-dimensional and/or three-dimensional image of at least the proximal end1104of the tibia1106. The virtual model of the bone, along with other models discussed herein, can be computer generated in a variety of manners, as discussed, for example, in U.S. patent application Ser. No. 14/232,958, filed on Mar. 21, 2014, the contents of which are incorporated herein in their entirety. For example, according to certain embodiments, using appropriate software, two and/or three-dimensional more images taken at block1302, as well as possible associated extrapolation, can be used to generate a three-dimensional model of the bone(s). Alternatively, or optionally, the one or more images, as well as an associated template or model based on the particular type of bone that was the subject of the imaging at block1302, can be used to generate two-dimensional and/or three-dimensional virtual model(s) of the bone(s).

Alternatively, according to certain embodiments, a model of the patient's bone may not necessarily be generated. Instead, for example, measurements from the patient, and/or an application, such as, for example, a web based application can be used that can allow the user to be provided with virtual implant preparation information visualization. Further, such implant visualizing can be achieved in a variety of different manners, including, for example, via use of a medical image viewer, which may provide visualization of at least both patient imaging and implant geometry, which can provide information that can be used to design instrument(s) for the patient for use during the implantation procedure.

Optionally, similar to block1302, the process1300can also include, at block1306, obtaining one or more images of at least some of the ligaments that may be directly affected by, or otherwise involved in, the planned surgical procedure. For example, with respect to a preparatory procedure involving the tibia1106for an knee implant procedure, one or more images can be attained at block1306using a variety of different imaging sources or technology that provide at least visual information pertaining to characteristics of at least some ligaments at or around the bone, are moreover, in this example, the tibia1106. Such images can provide a variety of information, including, for example, information that detects, or which may be used to determine, the location at which the ligament(s) attach to the bone. For example, with respect to the tibia1106, such information may indicate and/or provide information that can be used to determine or approximate insertion locations of the anterior cruciate ligament (ACL) and/or the posterior cruciate ligament (PCL) relative to the tibial eminence1108. While attaining such information may be useful with certain knee implant procedures, such as, for example, uni-compartmental knee replacement (UKA) and bi-cruciate knee replacement (XR), for at least other types of knee implant procedures in which the ACL and PCL (if present) may be removed, such as, for example, total knee replacement (TKA), such information may be unnecessary.

At block1308, the images obtained at block1306can be used to generate a two-dimensional and/or three-dimensional model or representation of the ligaments. Similar to block1304, the model generated at block1308can, using the appropriate software, be generated using at least some two-dimensional and/or three-dimensional images and/or information, as well as via possible associated extrapolation and/or models or templates associated with those ligaments and/or the corresponding joint. Further, while blocks1302,1304, are discussed separately from the blocks1306,1308associated with the imaging and virtual model generation for the ligament(s), according to certain embodiments, the images obtained at either block1302or1306can be used in connection with generating a two and/or three-dimensional virtual model(s). For example, blocks1302and1304can be used at either block1304or1308that includes both the bone(s) and the associated ligament(s). Alternatively, to the extent that separate virtual models of the bone(s) and ligament(s) are each generated at blocks1304,1308, according to certain embodiments, those separate models may be combined or incorporated so that a single model is provided that depicts both the bone(s) and the ligament(s).

Optionally, according to certain embodiments, the process1300can include, at block1310, obtaining two-dimensional and/or three-dimensional images of the implant system and/or associated component or preparatory tool that will be implanted or otherwise used in preparing the bone and/or joint for the implantation. According to such an embodiment, the process1300can also include at block1312, and similar to blocks1304and1308, use of at least some of the images obtained at block1310to generate, using appropriate software, a two-dimensional and/or three-dimensional virtual model of the implant system and/or associated component or preparatory tool. Alternatively, rather than generating a three-dimensional model via such images, the two-dimensional and/or three dimensional model may be provided via a computer-added design or other computer design or image file(s) that corresponds to the particular implant system and/or associated component or preparatory tool. For example, such models can be files that are provided by the manufacturer of the implant system and/or of the associated component or preparatory tool and which are imported and/or uploaded to the computer system being used for the evaluation of the system. Further, the implant system and/or associated implant components can also be imported without specifying component sizes so that, during process1300, optimum components sizes can be determined or selected by the based on the below-discussed analyses and/or associated information or data.

At block1314, the models generated at blocks1304,1308,1312, or otherwise provided, can be analyzed. According to certain embodiments, such analysis can include displaying, on a display or monitor, the corresponding size and/or shape of the bone at particular potential bone cut locations. Such analysis may provide at least a virtual representation, on the display, and before actual cutting of the bone, of the resulting size and shape of the resected bone surface following the bone cut at that particular location(s), including depth, of the bone. Moreover, such an analysis can include attaining visual representations of the resulting size and/or shape of the resected bone surface at a plurality of different cut locations. Thus, based on such virtual information, including a comparison of the differences in the resulting size and/or shape of the resected bone at different bone cut locations, a preoperative decision can be made as to a particular location, or depth, at which the cut in the bone is to be made. Such preference, could, for example, be based on the extent to which the resulting size and/or shape of the resulting resected bone surface conforms to the size and/or shape of the implant system and/or component that may be positioned at that location. For example, with respect to the tibia1106, such analysis can include the extent to which there will be cortical rim contact and/or bone coverage by a tibial plate that may be secured to, or positioned adjacent to, the resected bone surface. Such analysis can also include investigating potential resulting weaknesses in the cut bone and surrounding portions of the bone, including, for example, potential resulting weakening of the tibial eminence1108, that could be created or enhanced by resecting the bone at a particular location and/or depth.

Other factors or considerations, in addition to the size and/or shape of the resected bone surface formed by cutting into the bone at a particular bone cut location can also be considered when determining the location for bony resection. For example, at block1316according to certain embodiments and/or surgical procedures, the impact that bony resection may have on any associated ligament(s) may also be virtually analyzed, such as, for example, by a virtual representation on the screen that may, or may not, be the same as the displayed virtual representation of the bone. Such analysis can include detecting the insertion location of ligaments into the bone, such as, for example, the ACL and/or PCL into the tibia1106.

According to certain embodiments, the process1300can also include, at block1318, evaluating the trade-offs or compromises that may made to one or more considerations for bony resections at different locations along the bone. For example, with respect to at least the discussed tibia1106example, there may not necessarily be a fixed relationship between obtaining tibial tray1122coverage of the resected bone surface and maintaining the integrity of the corresponding or adjacent ligament(s). Thus, while cutting the bone at a certain depth may be beneficial in terms of the resulting size and/or shape of the bone providing a surface for optimal tibial tray coverage, cutting to such a depth can adversely impact the connection, or strength thereof, between the tibia1106and the ACL and/or PCL. Conversely, resecting a bone at a location that may be optimal in terms of the connection of the ACL and/or PCL to the tibia1106may be less then optimal for tibial tray1122coverage. Further considerations may be given more weight and importance, including, for example, based on the relative importance to the safety and/or needs of the patient and/or the functionality of the implant system, among other bases.

Thus, at block1318, preoperative decisions, and/or options, as to the location at which bony resection may occur, and the associated tradeoffs or compromises with respect to certain considerations, including tibial coverage and ligament insertion locations, among other considerations, can be evaluated. According to certain embodiments, such trade-offs or compromises can be evaluated in connection with generating virtual visualization information pertaining to bone cuts for a plurality of bone cut locations and/or virtual visualization of information pertaining to the associated ligaments, among other information. As previously discussed, such visualization information can include, for bone cuts at a plurality of locations along the bone, one or more virtual versions, images, and/or representations of the resulting resected bone surface for each particular bone cut location. According to certain embodiments, such virtual information can also include relevant measurements or sizes, as well as representations of other features of the patient's anatomy or the associated implant system or component. Further, according to certain embodiments, such information can be provided for approval or modification such as, for example, approval and/or modification by one or more members of a surgical team. However, again, such evaluation can be preoperative, and thus may assist in reducing the above-discussed surprises that can traditionally occur when the size and/or shape of the bone is realized during and/or after the resection of the bone.

At block1320, one or more virtual procedures or operations using one or more of the above-discussed virtual bone cut locations can be performed. For example, a surgeon or engineer may first virtually size and virtually implant the above-discussed modeled implant onto the above-discussed modeled bone, which, in the illustrated example, is a virtual knee implant component on a virtual representation of the patient's tibia. Such virtual implantation can include attempting to obtain the best bone fit and mechanical axis alignment as is typically conventionally done, but without the pressure and associated risks of an actual surgery. This initial virtual sizing and virtual placement can be based on a variety of surgical techniques, including, for example, techniques used to determine internal-external (IE) rotation of the tibia.

According to certain embodiments, such virtual procedures or operations can be performed in connection with analyzing the trade-offs or compromises discussed above with respect to block1318. Alternatively, according to other embodiments, the virtual surgery can be performed after the selection of one or more bone cut locations from block1318. The virtual surgery provides a further opportunity to evaluate the selected location for bony resection, as well as any associated trade-offs or compromises. Such evaluation can, in at least certain circumstances, result in modifications, adjustments, and/or an identification of discrepancies in at least the planned bone cut location, among other potential modifications. For example, the virtual surgery at block1320can provide information indicating the stresses in associated bone, ligaments, muscle, and or tissue. The virtual surgery can also include, at block1320, evaluating and/or modifying the sizing and/or configuration of components of the implant system and/or associated preparatory tools based on the size and/or shape of the bone at the selected bone cut.

According to certain embodiments, the virtual surgery can also include evaluating, or determining, the positioning of one or more pin holes in the bone. With respect to the tibia1106, such pin holes can include distal holes that are used to line-up a datum block of a guide, which, as discussed below, can provide a platform that can establish a plane parallel to the bone cut of the tibia1106that will be made via use of a cutting slot of a cutting block or guide. Additionally, or optionally, the pin holes can also include an eminence pin hole, which can be used to set the medial-lateral (ML) position and internal-external (IE) rotation, of a tibial eminence for a vertical eminence cut. The virtual surgery can also, according to certain embodiments, include marking, in the virtual visualization of the bone and associated surgery, the location of the anterior eminence cut.

Thus, based on information obtained during the virtual surgery, consideration may be given as to whether to modify the preoperative plan. For example, such modifications could include modifying the bone cut location, the orientation of the bone cut, the orientation and/or size of any components of the implant system, and/or a ligament release location, among other possible modifications. Accordingly, the virtual surgery, among other steps in the process1300can be an iterative process in which the impact of certain adjustments, modifications and/or options can be evaluated in connection with determining the operative plan, and including the associated implant components, that will eventually be selected for use during surgery.

According to certain embodiments, upon completion of the virtual surgery or surgeries and the compiling of the associated data, one or more suggested locations of the bone cut and/or suggested sizes or features of the associated implant component can be presented for one or more members of the surgical team. For example, the data obtained from the virtual surgery can provide sizes and/or relative spatial orientations the bone and/or implant component(s), along with one or more expected performance characteristics, such as, for example, ligament tension, range of motion, efficiency, stress environment(s), fixation strength, ligament balance, anatomic fit (e.g., bone fit), fixation force(s), and/or implant longevity, associated with said suggested sizes and relative spatial orientations. The surgeon may then decide to re-orient the components of the prosthesis and/or the bone cut location based on expected performance characteristics calculated by the software in order to optimize anatomic fit and biomechanic performance.

Additionally, various portions or steps of the process1300discussed herein, including, but not limited to, the virtual surgery at block1320, can utilize a medical image viewer. Further, for example, the various models discussed herein can be viewed in such a medical image viewer and used for a variety of purposes, including, but not limited to, reporting the proper pose of implant cuts as well as generating information that can be used in instrument guide design.

At block1322, a cutting block or guide can be created that has features that generally correspond to, at least in part, the guide that was approved and/or modified from at least the virtual surgery. According to certain embodiments, such a guide can also be built with pin holes, including the above-discussed pin holes for the datum block and eminence pin hole, that correspond with the features of the guide block that were deemed suitable, or otherwise modified based on, at least the virtual surgery from block1320. Alternatively, according to certain embodiments, the location and/or orientation of the pin holes for the datum block and eminence pin hole, as well as other pin holes, can be, at least in part, based on other features of the guide, such as, for example, the location and/or orientation of the cutting slot. According to certain embodiments, such a cutting slot and pin holes in the guide can be oriented to the same articular surfaces that guide the block on the bone during surgery.

Additionally, the virtual surgery, and associated determination of features of the corresponding custom-built cutting guide, can allow for the building of a single cutting guide that can handle a variety of different types of procedures. For example, according to the illustrated embodiment and use with knee implant procedures, a single guide can be built at block1322that can accommodate use for total knee replacement (TKA), uni-compartmental knee replacement (UKA), and bi-cruciate knee replacement (XR) procedures. Thus, for example, if during surgery the bone is discovered to have certain damage, such as, for example, arthritis, osteoporosis, and/or the bone is too hard, among other potential issues relating to the bone, the type of implant surgery, such as, for example, uni-compartmental knee replacement or bi-cruciate knee replacement that was to be performed, may be changed, such as, for example, changed to a total knee replacement procedure. Similarly, the type of implant procedure may also be changed, such as, for example, changed to a total knee replacement, if during the operation one or more ligaments is/are discovered to have certain damage or injury. According to the illustrated embodiment, the guide built at block1322can accommodate such intraoperative adjustments, as, as discussed above, in the illustrated example, as a single guide can be built to accommodate such different types of surgical and/or implant procedures.

FIGS.45-47illustrate an exemplary adaptive guide1200that can be built at block1322. As illustrated, the adaptive guide1200can include a paddle section1202, a cutting and alignment section1204, and an anterior pinning section1206. Similar to the exemplary tibial cutting block1100depicted inFIG.42, the paddle section1202can include an anterior tibial portion1208, a medial tibial paddle1210, and a lateral tibial paddle1212. The anterior tibial portion1208can be configured to overly a portion of the of the anterior face1114of the tibia1106, while the medial and lateral tibial paddles1210,1212can be configured to overly at least portions of the medial and lateral plateaus, respectively, of the tibia1106. Further, although not illustrated, the anterior tibial portion1208, medial tibial paddle1210, and lateral tibial paddle1212of the adaptive guide1200can include bone-interfacing surfaces that are configured to interact with opposing portions of the proximal end1104of the tibia1106and/or associated cartilage at or around the tibia1106.

According to the illustrated embodiment, the medial and lateral tibial paddles1210,1212of the adaptive guide1200can each include one of the one or more paddle pin holes. The paddle pin holes can be positioned such that, when the adaptive guide1200is operably positioned on the proximal end1104of the tibia1106, pins that extend through the paddle pin holes in medial and lateral tibial paddles1210,1212can enter into the proximal end1104of the tibia1106.

Guide bosses1213can extend around one or more of the paddle pin holes that can assist in directing the pins1214(FIGS.48A and48B) into/through the paddle pin holes and into the adjacent proximal end1104of the tibia1106. The guide bosses1213can have an outwardly extending size that can guide the displacement of pins through at least the corresponding paddle pin holes, and thus through the adaptive guide1200, as the pins are impacted, drilled, or otherwise inserted into an adjacent portion of the tibia1106. Each guide boss1213includes a guide orifice1216that is in fluid communication with the paddle pin holes, and which is sized to accommodate passage of a pin through the guide boss1213. The guide bosses1213can be configured to direct the pins away from the edges of the tibia1106and/or generally limit the angular directions at which the pin can extend through the associated adaptive guide1200. Additionally, the relative placement of the guide bosses1213, as well as the relative location of the associated adaptive guide1200, can allow for pins to be placed into the tibia1106at locations that can accommodate further, or other, distal cuts of the tibia1106, including, but not limited to, one or more recuts of the tibia1106, that can be used to prepare the bone interfacing surface(s) of the tibia1106for implantation of a corresponding portion of the knee implant system.

According to certain embodiments, one or more of the guide bosses1213includes a boss body1218and a removable capture portion1220that generally define at least a portion of the guide orifice1216. As shown by at leastFIG.48A, the capture portion1220is coupled to the boss body1218by a neck portion1222that is sized to provide an undercut between the boss body1218and the capture portion1220. Moreover, the neck portion1222provides a recess or undercut around at least a portion of the guide boss1213. Thus, a cross-sectional wall thickness between an inner wall of the guide boss at the guide orifice1216and an outer wall of the guide boss1213at the neck portion1222can be thinner than a corresponding cross-sectional wall thickness between the inner wall at the guide orifice1216and the outer wall of the guide boss1213at the boss body1218and/or the capture portion1220. Further, a recess or undercut provided by the neck portion1222can be sized to receive a tool, such as, for example a rongeur, that can be positioned in the recess or undercut provided by the neck portion1222and beneath the capture portion1220. According to such an embodiment, as indicated by at leastFIG.48B, a pulling and/or twisting force can be provided, via the tool, against the neck portion1222and/or the capture portion1220, such as, for example, a bottom wall1224of the capture portion1220, that can break the guide boss1213, such as at the neck portion1222, in a manner that allows the capture portion1220to be detached from the boss body1218. Thus, in the event a pin1214received in the guide orifice1216of the guide boss1213is over driven into the guide boss1213, the capture portion1220can be selectively removed so as to expose a portion of the over-driven pin1214that can be subsequently coupled to a driver and backed out of the guide boss1213and/or out of the associated bone.

ReferencingFIG.46, according to certain embodiments, one or both of the medial and lateral tibial paddles1210,1212of the adaptive guide1200can also include a selectively removable paddle extension1226. As shown, the paddle extension1226can be sized to extend a length at which the associated medial tibial paddle1210and/or lateral tibial paddle1212extends across the proximal end1104of the tibia1106at least in the direction of the posterior side of the tibia1106. According to the illustrated embodiment, the paddle extension1226can be, at certain locations, separated from the adjacent portion of the medial or lateral tibial paddle1210,1212by one or more perforations1228. For example, in the illustrated example, a first perforation1228can extend through a portion of a sidewall1230of the lateral tibial paddle1212, while a second perforation1228can extend through a portion of a generally central area between the paddle extension1226and the remainder of the lateral tibial paddle1212. The perforations1228can provide weakened areas and/or a bending location in the medial and/or lateral tibial paddle1210,1212that can facilitate the selective detachment of the paddle extension1226from the associated medial and/or lateral tibial paddle1210,1212.

ReferencingFIGS.45-47, the paddle section1202can also include an eminence indicator1232that can be generally positioned in, or otherwise extend into, an area between the medial and lateral tibial paddles1210,1212of the adaptive guide1200. The eminence indicator1232can be configured to provide a visual indicator as to a location of at least a portion of bone that is to remain generally intact during, and after, bony resection. For example, according to the illustrated embodiment, the eminence indicator1232can be positioned to at least indicate a width and an end location of at least a portion of the tibial eminence1108that, at least according to the decisions made in preoperative planning, is not to be removed during bony resection. Further, according to the illustrated embodiment, at least a portion of the eminence indicator1232can provide a guide for a marking instrument to transfer the information or locations provided by the eminence indicator1232to the bone. For example, a marking instrument, such as, for example, a surgical pen, among other marking instruments, can use at least a portion of the eminence indicator1232as a guide as the marking instrument transfers information, such as particular locations, provided by the eminence indicator1232to the generally adjacent bone surface of the patient's bone.

According to the illustrated embodiment, the eminence indicator1232comprises opposing first and second segments1234,1236. According to certain embodiments, the first segment1234can comprise a portion of the medial tibial paddle1210, such as, for example, at least a portion of an inner sidewall1238of the medial tibial paddle1210. Alternatively, according to other embodiments, the first segment1234can include a first body portion1240that inwardly extends from at least a portion of medial tibial paddle1210, such as the inner sidewall1238of the medial tibial paddle1210, and generally extends at least in the direction of the opposing lateral tibial paddle1212. According to the illustrated embodiment, the first body portion1240of the first segment1234can be generally defined by opposing posterior and anterior walls1242,1244, as well as a medial wall1246that is generally positioned opposite of the medial tibial paddle1210.

Additionally, according to the illustrated embodiment, the first segment1234can also include a first arm1248that inwardly extends from the medial wall1246, and generally extends in at least the direction of the second segment1236. The first arm1248can include opposing first and second walls1248,1250. As shown by at leastFIG.47, according to at least certain embodiments, the first wall1250of the first arm1248can be generally parallel to the second wall1252. Additionally, according to the illustrated embodiment, the second wall1252can extend from the anterior wall1244of the first body portion1240of the first segment1234. Further, as shown in at leastFIG.47, although the first wall1250can be oriented in a variety of manners with respect to the medial wall1246of the first body portion1240of the first segment1234, according to the illustrated embodiment, the first wall1250can be generally perpendicular to the medial wall1246.

With respect to the second segment1236, according to certain embodiments, the second segment1236can comprise a portion of the lateral tibial paddle1212, such as, for example, at least a portion of an inner sidewall1254of the lateral tibial paddle1212. Alternatively, according to other embodiments, the second segment1236can include a second body portion1256that inwardly extends from at least a portion of the lateral tibial paddle1212and generally in the direction of the medial tibial paddle1210. According to the illustrated embodiment, the second body portion1256of the second segment1236can be generally defined by opposing posterior and anterior walls1258,1260as well as a lateral wall1262that is generally positioned on an opposite side of the lateral tibial paddle1212.

Additionally, according to the illustrated embodiment, the second segment1236can also include a second arm1264that inwardly extends from the lateral wall1262generally in the direction of the second segment1236, and moreover, in the direction of the first arm1248. The second arm1264can include opposing first and second walls1266,1268. As shown by at leastFIG.47, according to at least certain embodiments, the first wall1266of the second arm1264can be generally parallel to the second wall1268. Additionally, according to the illustrated embodiment, the second wall1268can extend from the anterior wall1260of the second body portion1256of the second segment1236. Further, as shown in at leastFIG.47, although the first wall1266can be oriented in a variety of manners with respect to the lateral wall1262of the second body portion1256of the second segment1236, according to the illustrated embodiment, the first wall1266can be generally perpendicular to the lateral wall1262.

Additionally, according to the illustrated embodiment, the medial wall1246of the first segment1234can be generally parallel to the lateral wall1262of the second segment1236. Further, the first walls1250,1266of the first and second arms1248,1264can be generally parallel and aligned with each other such that, absent a gap1270therebetween, the first wall1250of the first arm1248could be a continuation of the first wall1266of the second arm1264. Similarly, according to certain embodiments, the second walls1252,1268of the first and second arms1248,1264can be generally parallel and aligned with each other such that, absent the gap1270therebetween, second wall1252of the first arm1248could be a continuation of the second wall1268of the second arm1264.

According to the illustrated embodiment, at least the medial and lateral walls1246,1262of the first and second body portions1240,1256, and the first walls1250,1266of the first and second arms1248,1264can generally define an eminence gap1272that is sized to generally correspond to a size of at least a portion of the tibial eminence1108that is not to be removed during resection of the tibia1106. For example, the medial and lateral walls1246,1262of the first and second body portions1240,1256can be separated by a distance that can generally correspond to a width of the tibial eminence1108that is to be retained. Further, the first walls1250,1266of the first and second arms1248,1264can generally define an ending location of the tibial eminence1108. Thus, according to certain embodiments, the combination of the medial wall1246and the first wall1250of the first arm1248and the combination of the lateral wall1262and the first wall1266of the second arm1264can provide an indication of the anterior corners of the tibial eminence1108. Further, according to certain embodiments, the particular sizing and orientation of the eminence indicator1232, including, for example, the relative positions and/or orientations of at least the medial wall1246, lateral wall1262, first wall1250of the first arm1248, and/or the first wall1266of the second arm1264can be determined using the images and/or models from the process1300discussed above, among other information.

As previously discussed, in the illustrated embodiment, the location information provided by the eminence indicator1232can be transferred to the tibia1106to provide visual markers or borders that can correspond to the location of the anterior corners of an eminence cut. Moreover, such location and marking of the anterior corners of an eminence cut can provide an indication of which portions of the bone and/or tibial eminence1108are to be cut, and/or what portion(s) or region of the tibial eminence1108is/are not to be cut. For example, with the eminence indicator1232operably positioned via the operable coupling of the adaptive guide1200to the proximal end1104of the tibia1106, such as, for example, the adaptive guide1200pinned to the tibia1106at a selected or predetermined orientation and/or position, the edges of at least a portion of the eminence indicator1232can be traced or otherwise provide a guide for a marking instrument, such as, for example, a surgical pen, among other types of marking instruments. Thus, for example, the medial wall1246and lateral wall1262of the first and second segments1234,1236of the eminence indicator1232can be used as a guide for the marking instrument to place first and second markings1274a,1274b, respectively, (FIG.49) on the tibia1106that can indicate a location, or width, of the tibial eminence1108that is to be retained. Similarly, the first walls1250,1266of the first and second arms1248,1264can be used as guides for placing third and fourth markings1274c,1274d(FIG.49), respectively, that can indicate the ending location of the tibial eminence1108. Further, as shown byFIG.49, rather than being separate markings1274c,1274d, the marking location provided by the first walls1250,1266of the first and second arms1248,1264can form a continuous marking that extends between the first and second markings1274a,1274b, and thereby form at least the visual markings for the anterior corners of an eminence cut.

Additionally, according to certain embodiments, the medial tibial paddle1210can also be configured to provide an indication of a location of the internal-external (IE) rotation of the tibial eminence1108that is to be preserved. For example, according to the illustrated embodiment, at least a portion of the inner sidewall1238of the medial tibial paddle1210can be configured such that, when the adaptive guide1200is operably secured to the tibia1106, the inner sidewall1238is positioned at a location that corresponds to at least a portion of the IE rotation of the tibial eminence1108that is to be preserved. Moreover, at least a portion of the inner sidewall1238of the medial tibial paddle1210can be configured to provide an edge that can, similar to the eminence indicator1232, provide a location that can be traced, or otherwise guide, a marking instrument that can transfer the location of the inner sidewall1238, and thus the indicated location of the IE rotation, to the proximal end1104of the tibia1106. For example,FIG.49illustrates a marking1274ethat has been transferred to the proximal end1104of the tibia using the inner sidewall1238of the medial tibial paddle1210as a guide, and which can provide an indication of the IE rotation that is to be preserved.

As shown in at leastFIGS.45and46, the cutting and alignment section1204of the adaptive guide1200can include a cutting slot1276and one or more pin holes1278. Similar to the cutting block1116discussed above with respect to the exemplary tibial cutting block1100depicted inFIG.42, the cutting slot1276of the adaptive guide1200can be sized to receive insertion of a cutting blade that can cut or resect the tibia1106. According to the illustrated embodiment, the cutting slot1276is oriented on the medial half of the anterior side of the adaptive guide1200, and can be formed through the bone interfacing portions of the adaptive guide1200, or may be recessed from the bone interfacing surfaces. The thickness of the cutting slot1276can help direct the orientation of the cutting tool, such as, for example, saw blade, as the cutting tool advances through the cutting slot1276. Further, the translation of the cutting slot1276relative to the adaptive guide1200, can, according to at least certain adaptive guides, assist in setting a resection depth.

Similar to other pin holes in the adaptive guide1200, the one or more pin holes1278of the cutting and alignment section1204can be configured to accommodate passage of at least a portion of a pin through each of the pin holes1278and into the tibia1106. According to the illustrated embodiment, at least a plurality of the pin holes1278can be positioned about the cutting and alignment section1204of the adaptive guide1200so that a pin inserted therein can extend into the tibia1106at, or in the general vicinity of, an anterior face1114of the tibia1106. Further, according to the illustrated embodiment, at least one pin hole1278a, also referred to as an orientation stylus pin hole, of the cutting and alignment section1204can be positioned to receive a pin that extends into a hole1280(FIG.49) in the tibia1106that can be used in connection with the later mounting of an armed portion1282of an orientation stylus1284, as shown inFIG.50, to the tibia1106.

The anterior pinning section1206of the adaptive guide1200can include pin holes1286a,1286bthat extend through the adaptive guide1200and into corresponding holes in, or around, at least the anterior face1114of the tibia1106. According to the illustrated embodiment, the pin holes1286a,1286bof the anterior pinning section1206can include at least some pin holes1286a,1286bthat can correspond to, or are otherwise be generally in alignment with, recut holes in the tibia1106. Such recut holes could, if used, correspond to the relatively secure placement of a recut cutting block using pins that extent into those recut holes in the tibia, and could be used in the event a subsequent re-cut of the tibia is to be performed. Alternatively, or optionally, the pin holes1286a,1286bcould be used at least in connection with pin holes in the tibia1106, and/or the associated pins received therein, for other preparatory tools that can be secured to the tibia1106.

The adaptive guide1200can also include a datum block1290that can provide a platform that can establish a plane that is parallel to a cut in the tibia1106that is formed via using of cutting slot1276of the adaptive guide1200. As shown in at leastFIGS.45and46, the datum block1290can be positioned beneath the above-discussed pin holes1286a,1286bof the anterior pinning section1206. Further, according to the illustrated embodiment, the datum block1290can generally provide a distal end or side of the adaptive guide1200along at least a portion of the anterior side of the adaptive guide1200.

The datum block1290can also include one or more datum pin holes1288a,1288bthat, similar to the pin holes1286a,1286b, are configured to accommodate passage of at least a portion of a pin1292through the datum pin holes1288a,1288band into the tibia1106. According to certain embodiments, the datum pin holes1288a,1288bcan be configured to guide pins1292(FIG.47) to a location(s), and/or provide pins at a relative orientation, that can correspond to the pin hole arrangement(s) of other preparatory tools. For example, according to the illustrated embodiment, the datum pin holes1288a,1288bcomprises two datum pin holes1288a,1288bthat are configured to receive pins1292that are generally parallel to each other, and which extend into the anterior face1114of the tibia1106.

When the adaptive guide1200is removed from the tibia1106, a portion of an orientation stylus1284(FIG.49) having pin holes having a relative orientation similar to the anterior parallel pins1292can be secured to the tibia1106via at least the anterior parallel pins1292, as shown inFIG.49. As previously mentioned, the orientation stylus1284can include an armed portion1282that can, according to at least certain embodiments, be positioned relative to at least the tibia1106using a pin hole1280in the tibia1106that was generally aligned with the orientation stylus pin hole1278aof the adaptive guide1200. Further, such a process can also include aligning or centering arms1294of the armed portion1282of the orientation stylus1284with the above-discussed markings1274a-dthat were transferred to the tibia1106through use of the eminence indicator1232, as well as orienting the arms1294to be generally parallel to the marking1274ecorresponding to the IE rotation of the tibia1106, as discussed above.

FIG.51illustrates an anterior view of a general knee joint in which an exemplary femoral cutting block2100and an exemplary tibial cutting block2102are coupled to the associated femoral and tibial bones2104,2106, respectively. According to the depicted embodiment, the femoral and tibial cutting blocks2100,2102are configured to engage portions of bone and cartilage on the femur2104and tibia2106, respectively, in at least an attempt to align cutting surfaces within the cutting blocks2100,2102. More specifically, according to the depicted embodiment, the femoral cutting block2100is configured to facilitate a distal cut on the femur2104, and the tibial cutting block2102is configured to facilitate a proximal cut on the tibia2106, that can be made in connection with the installation of a knee replacement system. Moreover, according to the illustrated embodiment, the femoral and tibial cutting blocks2100,2102can be configured to provide guidance with respect to the resection of bone2104,2106for an implant procedure(s) and without the use of either intramedullary or extramedullary guides.

While, for at least purposes of illustration,FIG.51illustrates a pair of exemplary femoral and tibial cutting blocks2100,2102, embodiments of the subject application are applicable to a variety of cutting blocks and/or cutting blocks used for a variety of different types of procedures and/or implantations, as well as other preparatory implant tools. For example, according to certain embodiments, the femoral and tibial cutting blocks2100,2102can be configured for use in total knee replacement, uni-compartmental knee replacement, and/or bi-cruciate knee replacement. Additionally, as will be readily apparent herein, embodiments of the subject application are applicable to conventional slotted cutting blocks or guides, as well as patient-specific or customized cutting blocks. Further, the femoral and tibial cutting blocks2100,2102can be constructed from a variety of different materials, including, for example, metal, plastic, and/or nylon cutting blocks, as well as cutting blocks constructed from a variety of other materials. Additionally, while embodiments discussed herein are illustrated with respect to knee implant systems and the associated cutting blocks, the subject application is also applicable to implant systems and tools, including, for example, implant systems relating to shoulders and hips, among other implant systems.

The exemplary femoral cutting block2100includes an anterior femoral portion2108, a medial femoral paddle2110, and a lateral femoral paddle2112. According to the illustrated embodiment, these portions2108,2110,2112of the femoral cutting block2100can be configured to, when the femoral cutting block2100is operably positioned and/or secured to the distal end2128of the femur2104, overlie portions of the anterior face, medial condyle and lateral condyle of the femur2104, respectively.

As shown in the illustrated embodiment, at least the exterior surface of the femoral cutting block2100can include one or more pin holes2114a-d, guide bosses2115, a mechanical axis index2116, and a cutting slot2118. According to certain embodiments, the mechanical axis index2116can provide a visual reference point(s) at which the surgeon can, in connection with operably positioning and securing the femoral cutting block2100to the femur2104, generally align the femoral cutting block2100with the mechanical axis of the femur2104. According to at least certain procedures, imaging of the patient, including, for example, magnetic resonance imaging (MM), X-ray(s), and/or computerized tomography (CT) scans, among other imaging techniques, of at least the femur2104can be used to assist with at least attempting to aligning the mechanical axis index2116of the femoral cutting block2100to the mechanical axis of the femur2104.

The femoral cutting block2100can further include a cutting slot2118that is sized to receive insertion of a cutting blade that can cut or resect the femur2104. Further, the cutting slot2118can be configured to at least assist in guiding the location, including depth, at which the blade that is inserted into the cutting slot2118, and reciprocated or otherwise operated therein, is to cut into the femur2104. Thus, the cutting slot2118can be oriented, via the orientation of the femoral cutting block2100relative to the femur2104, to direct the distal cut on the femur2104for preparation of implantation of the associated implant device or system. When positioning and/or orienting the femoral cutting block2100onto and/or relative to the femur2104, one or more imaging techniques and/or surgeon preference may be used to determine a location of the cutting slot2118of the femoral cutting block2100relative to the femur2104, for example as described above.

As discussed below, one or more pin holes2114a-dof the femoral cutting block2100can be configured and/or oriented to receive pins that extend through the pin holes2114a-dand into an adjacent portion of the femur2104. At least some of the pins can assist with generally operably securing, coupling, and/or pinning the femoral cutting block2100at a selected position and/or orientation to the femur2104, while other pins, and/or the associated pin holes in the patient's bone can assist in at least aligning at least a portion of the implant system that will be implanted in the patient.

Guide bosses2115can extend around one or more of the pin holes2114a-dthat can assist in directing the pins into/through the pin holes2114a-dand into the adjacent bone. The guide bosses2115can have an outwardly extending size that can guide the displacement of pins through at least the corresponding pin hole2114a-d, and thus through the femoral cutting block2100, as the pins are impacted, drilled, or otherwise inserted into an adjacent portion of the femur2104. For example, the bosses2115can be configured to at least direct the pins away from the edges of the bone and/or generally limit the angular directions at which the pin can extend through the associated pin hole2114a-d. Additionally, the relative placement of the bosses2115, as well as the relative location of the associated pin holes2114a-d, can allow for pins to be placed into the femur2104at locations that can accommodate further, or other, distal cuts of the femur2104, including, but not limited to, one or more recuts of the femur2104, that may be used to prepare the bone interfacing surface(s) of the femur2104for implantation of a corresponding portion of the knee implant system.

A first set of one or more of the pin holes2114a,2114b, referred to herein as recut holes2114a,2114b, can be oriented on an anterior face portion2120of the femoral cutting block2100, including, for example, generally at or in relative proximity to the anterior femoral portion2108. Thus, according to the illustrated embodiment, the recut holes2114a,2114bcan each be oriented to receive passage of a pin that enters, and is inserted into, the anterior face2122of the femur2104.FIG.54provides an example location in the femur2104at which pins that were driven through recut pin holes2114a,2114bof the exemplary femoral cutting block2100can form recut holes2124through the anterior face2122, and into a portion, of the femur2104. Additionally, according to certain embodiments, one or more of the recut holes2114a,2114bcan have guide bosses2115. Alternatively, or optionally, one or more recut holes2114a,2114bof the femoral cutting block2100can, similar to the auxiliary pin hole2117inFIG.51, be generally flush with the adjacent surface of the anterior face2122of the femoral cutting block2100.

According to the illustrated embodiment, the medial and lateral femoral paddles2110,2112can include a second set of one or more pin holes2114c,2114d, referred to collectively as paddle holes2114c,2114d. As shown for example by at leastFIGS.52and53, according to the illustrated embodiment, the medial and lateral femoral paddles2110,2112can each include one or more paddle holes2114c,2114d. Further, according to at least certain embodiments, as shown in at leastFIG.52, the paddle holes2114c,2114dcan be located in relatively thin posterior portions of the medial and lateral femoral paddles2110,2112. According to the illustrated embodiment, the paddle holes2114c,2114dcan be positioned such that, when the femoral cutting block2100is operably positioned on the femur2104, pins that extend through the paddle holes2114c,2114din medial and lateral femoral paddles2110,2112enter into a distal end2128of the femur2104, such as, for example, into at least the medial and lateral condyles, respectively, of the femur2104.FIG.54provides an example illustration of the location of the distal holes2126formed in the distal end2128(FIG.51) of the femur2104via pins that were inserted into the paddle holes2114c,2114din medial and lateral femoral paddles2110,2112of the femoral cutting block2100. As is apparent,FIG.54depicts a portion of the distal holes2126that extend through a cut surface2130of the femur2104that was formed via resection of at least a portion of the distal end2128of the femur2104.

The second set of pin holes, or paddle holes,2114c,2114dof the femoral cutting block2100can be oriented relative to each other based on a particular design of the implant type, such as, for example, the design of the associated model, brand, and/or manufacturer of knee implant system, that is being, or will be, implanted in the patient. Moreover, the paddle holes2114c,2114dof the femoral cutting block2100can be oriented relative to each other to correspond to the location and/or orientation at which the distal holes2126are, or are to be, in the femur2104for the particular implant system that is being, or will be, implanted in the patient. Further, such relative locations of the distal holes2126in the femur2104can be implant specific in that, for example, the location and/or orientation of the distal holes2126in the femur2104, and associated pins therein, for one particular knee implant system may be different from the location and/or the position of such distal holes2126for other knee implant systems.

Thus, for example, the paddle holes2114c,2114dof a first femoral cutting block2100may have a first configuration, such as, for example, a relative location and/or orientation about the medial and lateral femoral paddles2110,2112of the first femoral block2100, that corresponds to the relative location and/or orientation at which the distal holes2126are to be positioned in the femur2104based on the particular design of a first knee implant system, while a different second femoral cutting block2100can have paddle holes2114c,2114dat second configuration such as, for example, a relative location and/or orientation about the medial and lateral femoral paddles2110,2112of the second femoral block2100, that corresponds to the particular design of a second, different knee implant system, the first configuration being different from, and not compatible with, the second configuration. In such situations, the differences between, and incompatibility of, the first and second configurations of the paddle holes2114c,2114dof the different first and second cutting blocks may, traditionally, preclude the surgeon from being able to properly use the second femoral cutting block2100in connection with the implantation of the first knee implant system.

FIG.53illustrates bone facing surfaces of another exemplary femoral cutting block2100′. As shown, the femoral cutting block2100′ can include an anterior interfacing portion2132, a medial interfacing portion2134, a lateral interfacing portion2136, and an intercondylar interfacing portion2138. According to at least certain embodiments, the anterior interfacing portion2132can be positioned to overlie a portion of the anterior face2122of cartilage and bone of, and/or around, the femur2104. The medial interfacing portion2134, lateral interfacing portion2136, and intercondylar interfacing portion2138can overlie the medial, lateral and intercondylar notch portions of the condyles, respectively. As shown byFIG.53, according to at least certain embodiments, the recut holes2114a,2114bcan extend through the anterior interfacing portion2132, while the paddle holes2114c,2114dcan extend through one or both of the medial and lateral interfacing portions2134,2136.

ReferencingFIGS.51,55A and55B, the tibial cutting block2102can include an anterior tibial portion2140, a medial tibial paddle2142, and a lateral tibial paddle2144. The anterior tibial portion2140can be configured to overly a portion of the of the anterior face2146of the tibia2106, while the medial and lateral tibial paddles2142,2144can be configured to overly at least portions of the medial plateau and lateral plateau of the tibia2106, respectively. Further, although not illustrated, the anterior tibial portion2140, medial tibial paddle2142, and lateral tibial paddle2144of the tibial cutting block2102can include bone interfacing surfaces that are configured to interact with opposing portions of the proximal end2148of the tibia2106and/or associated cartilage at or around the tibia2106.

The tibial cutting block2102can include a cutting slot2150that is that is sized to receive insertion of a cutting blade that can cut or resect the tibia2106. According to the illustrated embodiment, the cutting slot2150is oriented on the medial half of the anterior side of the tibial cutting block2102. The cutting slot2150, as well as the cutting slot2118of the femoral cutting block2100, can be formed through the bone interfacing portions of the associated cutting block2100,2102, or may be recessed from the bone interfacing surfaces. The thickness of the cutting slots2118,2150can help direct the orientation of the cutting tool, such as, for example, saw blade, as the cutting tool advances through the cutting slot2118,2150. Further, the translation of the cutting slot2118,2150relative to the femoral cutting block2100and tibial cutting block2102, respectively, can, according to at least certain cutting blocks2100,2102, at least assist in setting a resection depth.

The tibial cutting block2102can include a plurality of pin holes2152a-d. Similar to the pin holes2114a-dof the femoral cutting block2100, the pin holes2152a-dof the tibial cutting block2102can be configured to receive pins that are inserted and/or driven into a portion of the tibia2106. As discussed below, at least some of the pin holes2152a,2152bcan be used to at least secure the tibial cutting block2102to the tibia2106, and some, but not necessarily all, of the pin holes2152c,2152dcan also be used in connection with pins and/or associated holes in the tibia2106that can assist in aligning the component of the implant system that will be implanted in the patient. Further, at least some of the pins and/or associated pin holes in the tibia2106that can be associated with use of the tibial cutting block2102can also be used for other preparatory tools during different stages of the implantation procedure.

A first set of one or more of the pin holes2152a,2152bof the tibial cutting block2102, referred to herein as recut holes2152a,2152b, can be oriented on an anterior face portion2154of the tibial cutting block2102, including, for example, generally at or in relative proximity to the cutting slot2150. According to the illustrated embodiment, the recut holes2152a,2152bcan each be oriented to receive passage of a pin that enters, and is inserted into, the anterior face2158of the tibia2106.FIG.56provides an example location in the tibia2106at which pins2157that can be driven through the recut holes2152a,2152bof the exemplary tibial cutting block2102can form recut holes2156through the anterior face2158, and into a portion, of the tibia2106, respectively. While the pins2157shown inFIG.56are depicted as extending only from the recut holes2156in the tibia2106, similar pins2157can be used in connection with the other pin holes2114a-d,2152c,2152dof the femur and tibial cutting blocks2100,2102and corresponding pin holes2124,2126,2160of the femur2104and tibia2106. Additionally, according to certain embodiments, one or more of the recut holes2152a,2152bcan have guide bosses2115similar to the guide bosses2115discussed above with respect to recut holes2114a,2114bof the femoral cutting block2100. Alternatively, or optionally, as depicted inFIGS.51,55A and55B, one or more of the recut holes2152a,2152bcan be generally flush with the adjacent surface of the anterior face2158of the tibia2106.

A second set of one or more pin holes2152c,2152d, referred to herein a paddle holes2152c,2152d, can extend through one or more of the medial and lateral tibial paddles2142,2144. As shown for example by at leastFIGS.55A and55B, according to the illustrated embodiment, the medial and lateral tibial paddles2142,2144can each include one of the one or more paddle holes2152c,2152d. Further, according to the illustrated embodiment, the paddle holes2152c,2152dcan be located at the proximal end2148of the tibia2106. According to the illustrated embodiment, the paddle holes2152c,2152dcan be positioned such that, when the tibial cutting block2102is operably positioned on the proximal end2148of the tibia2106, pins that extend through the paddle holes2152c,2152din medial and lateral tibial paddles2142,2144can enter into the proximal end2148of the tibia2106.FIG.56provides an example illustration of the location of the proximal holes2160formed in the proximal end2148of the tibia2106that are positioned to receive pins that are inserted into the paddle holes2152c,2152din medial and lateral tibial paddles2142,2144of the illustrated exemplary tibial cutting block2102. As is apparent,FIG.56depicts a portion of the proximal holes2160extending through a cut surface2162of the tibia2106that was formed via resection of at least a portion of the proximal end2148of the tibia2106.

Similar to the above-discussed paddle holes2114c,2114dof the femoral cutting block2100, the second set of pin holes, or paddle holes,2152c,2152din medial and lateral tibial paddles2142,2144of the tibial cutting block2102can also be oriented relative to at least each other based on the particular design of a pin hole configuration for the implant type, such as, for example, model, brand and/or manufacturer of the knee implant system that is being, or will be, implanted in the patient. Moreover, the paddle holes2152c,2152dof the tibial cutting block2102can be oriented relative to each other to correspond to the location and/or orientation at which the proximal holes2160are, or are to be at, in the tibia2106for the design of the particular implant system that is being, or will be, implanted in the patient. Thus, for example, the paddle holes2152c,2152dof a first tibial cutting block2102can have a first configuration, such as, for example, a relative location and/or orientation, about the medial and lateral tibial paddles2142,2144that correspond to the relative location and/or orientation at which the proximal holes2160are to be positioned in the tibia2106for the design of a first knee system, while another, different second tibial cutting block2102can have paddle holes2152c,2152dhaving a second configuration that corresponds to the relative location and/or orientation at which the proximal holes2160are to be positioned in the tibia2106for the design of a second, different knee system, the first configuration being different from, and not compatible with, the second configuration. In such situations, the differences between the first and second configurations of the paddle holes2152c,2152d, and associated incompatibility, can again traditionally preclude the surgeon from being able to properly use the second tibial cutting block2102in connection with the implantation of the first knee implant system.

Accordingly, certain types of implant systems can be designed so that the location and/or orientation of certain pin holes, and/or the pins that are received therein, are implant specific in that the positions of the holes and/or associated pins in the patient's bone(s) may be part of aligning a component(s) of that particular implant system that will be implanted in the patient. Thus, such implant specific pin holes and associated pins can have relative an orientation(s) or position(s) that is/are unique to that particular implant system. For example, as previously discussed, with respect to knee implant systems, the relative location and/or orientation of distal holes2126that are, or are to be, formed in the distal end2128of the femur2104, and/or the relative location and/or orientation of proximal holes2160that are, or are to be, formed in the proximal end of the tibia2106, can be generally specific to the type of implant device being implanted, such as, for example, the model, brand, and/or manufacturer of the implant system.

Thus, for example, with respect to the above-discussed femoral and tibial cutting blocks2100,2102, the associated paddle holes2114c,2114d,2152c,2152dcan have configurations that are compatible with the pin hole configuration for a particular knee implant system, and that pin hole configuration may be different from, as well as incompatible with, a similar type of pin hole configuration or design for other knee implant systems. Accordingly, when the associated femoral and tibial cutting block2100,2102is properly positioned on the femur2104or tibia2106, the paddle holes2114c,2114d,2152c,2152dcan generally align with, and/or be positioned at similar locations and/or orientations as, the actual or intended locations of the corresponding implant specific pin holes, namely the distal and proximal holes2126,2160in the femur2104or tibia2106, respectively, for one knee implant system, but may not be positioned for proper alignment with the distal or proximal holes2126,2160in the femur2104or tibia2106for other knee implant systems.

Conversely, other, non-implant-specific pin holes, and the associated pins positioned therein, can be used to secure and/or position certain implant preparatory tools used in connection with preparing bone2104,2106to receive an implant, but generally may not be used in connection with the eventual aligning of a component(s) of the implant system that will be implanted in the patient. For example, with respect to at least knee implant systems, recut holes2124,2156in the anterior face2122,2146of the femur2104and tibia2106, respectively, can be used in connection with securing and/or positioning a cutting block, and/or a recut cutting block, to the femur2104or tibia2106, but may not themselves be used in connection with aligning a component of the knee implant system that will be eventually implanted in the patient. Thus, preparatory implant tools, such as, for example, femoral and tibial cutting blocks2100,2102, can include both pin holes having configurations that are similar to, or otherwise compatible with, an implant-specific pin hole configuration of the implant system that is being implanted, such as, for example, the above-discussed paddle holes2114c,2114d,2152c,2152d, as well pin holes that have non-implant-specific pin hole configurations, such as, for example, recut holes2114c,2114d,2152c,2152d.

According to certain embodiments, preparatory tools designed for particular implant systems can be adapted for use with other implant systems. Moreover, for example, a first preparatory tool, such as, for example, a first cutting block, can be built for use with another implant system, such as, for example, a second implant system, for which the first preparatory tool was not specifically designed. Such building of the first preparatory tool for use with the implantation of the other system can include modifying a portion of that first preparatory tool so that the modified portion of the first preparatory tool conforms to the corresponding design of the other knee implant system, but may not necessarily, or no longer, conforms to the corresponding design of the first implant system.

For example, according to certain embodiments, a first preparatory tool, such as, for example, a cutting block, can be designed to have one or more first pin holes along a first pin hole configuration, the first pin holes and first pin hole configuration being specific to at least a first implant system. However, a surgeon may wish to use that first preparatory tool in connection with a second implant system. Yet, the second implant system may use a second preparatory tool in a manner similar to the intended use of the first preparatory tool that has one or more second pin holes along a second pin hole configuration that is not compatible with the first pin hole configuration of the first preparatory tool. According to certain embodiments, the surgeon can have the option of selecting that first preparatory tool for use with the implantation of the second implant system, and, based on that selection, have one or more features of the first preparatory tool be built to have features and/or a configuration that allows the first preparatory tool be compatible with the second implant system. Moreover, under the current example, the selected first preparatory can be built such that the first preparatory tool includes the second pin holes are arranged in accordance with the second pin hole configuration.

FIGS.57A and57Billustrate exemplary representations of snapshots of a portion of a graphical display presenting selectable options pertaining to knee implant systems and various different femoral cutting blocks. Such graphical displays can, for example, be provided from a variety of different sources, including, for example, via an on-line display from a manufacturer, that can be accessed via at least the internet. As shown, in the example provided byFIG.57A, a user, such as, for example, a surgeon, has the opportunity to indicate a knee system that has been or may be selected, for implantation in a patient. Moreover, in the illustrated example, the user is provided the opportunity to select, or identify, from a plurality of knee implant systems, the particular knee implant system that has been, or may be, selected for implantation in the patient, such as, for example, specifically identify one of “GII”, “Journey”, and “TC-PLUS”, along with the opportunity to select an “Other” option.

According to certain embodiments, after indicating the knee system that has been, or may be, selected, for implantation in the patient, the user can be presented the option of selecting particular preparatory tools for use during the implantation procedure. As shown byFIG.57B, the preparatory tools available for selection, such as, for example, a femur guide, can include both tools that were designed specifically for the implant system that was selected in connection withFIG.57A, as well as other alternative preparatory tools that were designed for other, different implant systems. For example, with reference toFIG.57A, if the user selected the “Journey” knee implant system, then that user may be also presented the option of using at least some of the preparatory tools designed for that selected knee implant system, such as the “Journey” femur guide. However, as shown byFIG.57B, the user can also be presented the option of selecting for use other, alternative preparatory tools that were not specifically designed for the selected knee implant system, such as, for example, selecting to use the femur guides that were designed for the “GII” or “TC-PLUS” knee implant systems. A determination of which other, alternative preparatory tools will be provided as user selectable options for a particular selected implant system can be based on a variety of different factors, including, for example, the ability to modify the other, alternative preparatory tool for use with selected, different implant system, the manufacturer(s) of the selected implant system and/or the preparatory tool, and/or the availability of the preparatory tool, among other considerations.

As discussed above, to the extent necessary, the selected other, alternative preparatory tool can be built, or otherwise be modified, to be compatible with at least certain aspects of the selected, different implant system. For example, with respect to the above-discussed femoral cutting block2100, if needed, one or more of the recut holes2114a,2114bcan each be oriented on the selected other, alternative preparatory tool so as to be at relative locations and/or orientations that is/are compatible with the recut pin hole configuration that is used by the femoral cutting block that was specifically designed for use with the selected knee implant system. Similarly, if needed, the paddle holes2114c,2114dcan also be positioned and/or oriented at locations that correspond to the locations at which the pin holes are to be positioned at the distal end2128of the femur2104. Thus, by providing such options to the user, a surgeon may be able to select for use, and have built in conformance with, a preparatory tool of the surgeon's choice or preference despite that preparatory tool not being specific to the implant system that the surgeon is implanting. Further, while the above-discussed example is discussed with respect to femur cutting blocks, similar features are also applicable to other preparatory tools for knee implant systems, as well as other types of implant systems, including, but not limited to, hip, shoulder, and wrist implant systems, among others.

According to other embodiments of the subject application, preparatory tools for implant procedures can be identified as being compatible for use different implant systems based on similarities or compatibility of non-implant-specific pin hole configurations. Such a system can provide surgeons with the option to select a particular tool, such as, for example, a cutting block or recut cutting block, that may not be specific to the implant system being implanted, but which has pin holes having a configuration(s) that is/are similar to, or otherwise compatible with, the configuration of the non-implant-specific pin holes of the implant system that is being implanted. Thus, such a system may, for at least certain bone preparatory procedures, provide an indication of preparatory tools that, although not specifically designed for the implant system that is, or is to be, implanted in the patient, are suitable alternatives, such as, for example, capable of being secured to the bone2104,2106using the same pins and/or pin holes2124,2156in the femur2104or tibia2106as other preparatory tools that are specific to the implant system that is being implanted in the patient. In addition to allowing surgeons to use tools that, although not designed specifically for the system that is being implanted, are compatible with that system, such a system can also enhance the likelihood that a surgeon can use a tool of the surgeon's preference, or for which the surgeon has more familiarity, experience, and/or training. Further, if needed, the selected alternative implant tool can be modified, manufactured, or otherwise provided with other pin holes that correspond to the configuration of at least some implant specific holes of the implant system being implanted.

For example, during at least certain operations, a cutting block, such as, for example, the femoral and/or tibial cutting block2100,2102, can be used to resect portions of the distal end2128of the femur2104and the proximal end2148of the tibia2106. As previously discussed, such a procedure can include inserting pins2157into recut holes2124,2156, as well as into distal and proximal holes2126,2160in the femur and tibia2104,2106, respectively. Such recut holes2124,2156in the femur and tibia2104,2106, respectively, can be positioned on the respective bone2104,2106in at a non-implant-specific pin hole configuration, as those pin holes2124,2126, as those recut holes2124,2156may not be used to align the subsequently implanted component of the implant system.

In at least certain circumstances, following resection of the femur2104and/or tibia2106, the surgeon may elect to recut one or both of the bones2104,2106. For example, during the cutting procedure, the blade in the cutting slot2118,2150may deflect in a direction toward or away from the bone, and/or the cut may not necessarily extend far enough into the bone, such that the surgeon may elect to proceed with a recut of that bone(s)2104,2106. In such a situation, according to certain embodiments, rather than being limited to using a recut cutting block that is specific to the implant system that is being implanted, other recut cutting blocks that are designed for other, different implant systems can be selected for use based on those other or alternative recut blocks having a non-implant-specific pin holes that is/are compatible with the configuration of the non-implant-specific recut holes2124,2156formed in the bone2104,2106.

For example, in connection with the presently discussed knee implant example, one or more alternative recut cutting blocks that are not specific to the knee implant system being implanted, may be identified based on those alternative recut cutting blocks providing a recut pin hole configuration that is compatible with the configuration of the recut holes2114a,2114b,2152a,2152bof the femoral and/or tibial cutting block(s)2100,2102and/or the configuration of the recut holes2124,2156that are, or will be, formed in the corresponding bone(s)2104,2106.

With reference to the identified alternative recut cutting blocks, a decision can be made, such as, for example, by the surgeon, as to whether to select for use in a recut procedure one of the alternative recut cutting blocks, or to otherwise proceed with a recut cutting block that is specific to the implant system that is being implanted. Such a selection can be based on a variety of different factors, including, but not limited to, the surgeon's familiarity or preference with respect to the available recut cutting blocks and the recut cutting block of the system being implanted. Further, in the event an alternative recut cutting block is selected, in at least certain situations, the option can be available to provide the selected alternative recut cutting block with the implant-specific pin holes. For example, according to the discussed example, the option may be provide to have the selected alternative recut cutting block modified to have the recut cutting block have paddle holes at locations that correspond to location and orientation of the paddle holes2114c,2114d,2152c,2152din the femoral and/or tibial cutting block2100,2102used, or that will be used, to make the initial cut in the bone2104,2106, and/or are compatible to the relative location(s) of the distal and/or proximal holes2126,2160that are in, or otherwise are to be formed in, the bone2104,2106.

While the above example is discussed in terms of selection of an alternative recut tool, a similar process can also be available for other preparatory tools, including, but not limited to, the selection of a femoral and/or tibial cutting blocks2100,2102that may be used for the initial cut(s) of the distal and proximal ends2128,2148of the femur and tibia2104,2106, respectively, among other preparatory tools. Additionally, such other preparatory tools are not limited to planner slot cut blocks. For example, according to certain embodiments, the above-discussed processes can include selection of a planning reamer, among other tools, for resurfacing procedures. Additionally, at least some of the pins associated with the above-discussed procedures, such as, for example, recut pin holes2114c,2114d,2152c,2152d, can also be arranged and/or configured to receive sensors that can, for example, be utilized for computer-aided surgery or ligament balancers, among other uses. Further, while the examples discussed herein are with respect to knee implant systems and tools, embodiments of the subject application are also applicable to other implant devices.

FIGS.58A and58Billustrate anterior and distal views, respectively, of an exemplary femoral recut cutting block2164that is designed for an implant knee system that is different from the knee implant system for which the femoral cutting block2100depicted inFIGS.51and52is designed. According to the illustrated example, the femoral recut cutting block2164has a plurality of sets of non-implant-specific pin holes that are similar to, or compatible with, the non-implant-specific holes of the femoral cutting block2100. Moreover, in the illustrated example, the femoral recut cutting block2164has four recut hole sets2166a-d, each set having at least two recut holes2168a-dthat extend through an anterior face portion2165of the femoral recut cutting block2164. Further, the recut holes2168a-din each recut hole set2166a-dhave a relative arrangement similar to the non-patient-specific pin holes of at least the femoral cutting block2100depicted inFIGS.51and52, and more specifically, the recut holes2114a,2114bof the illustrated femoral cutting block2100. Thus, each set of the recut holes2168a-din the femoral recut cutting block2164can be arranged in a manner that is compatible with the location and orientation of the recut holes2124that are, or are to be, formed in the femur2104, as well as the associated location and/or orientation of the pins2157that are (or are to be) inserted therein.

For example, the femoral recut cutting block2164depicted in at leastFIG.58Ahas a first recut hole set2166acomprising a pair of recut holes2168athat have a relative location and/or orientation to each other that is similar to the relative location and/or orientation of the recut holes2114a,2114bof the femoral cutting block2100depicted inFIGS.51and52. Similarly, the illustrated femoral recut cutting block2164also includes second, third, and fourth recut sets2166b-d, each set2166b-dalso comprising a pair of recut holes2168b-dhaving a relative location and/or orientation that corresponds to the relative location and/or orientation of the recut holes2114a,2114bof the femoral cutting block2100depicted inFIGS.51and52. Thus, according to such an embodiment, similar to the recut holes2114a,2114bof the femoral cutting block2100, the recut holes2168a-dof any of the recut hole set2166a-dof the depicted femoral recut cutting block2164can be generally, and selectively, aligned at the same position relative to the corresponding recut holes2124in the femur2104.

Additionally, in the illustrated example, each recut hole set2166a-dof the femoral recut cutting block2164is generally aligned along an axis2170a-d, each axis2170a-dbeing offset from the axis2170a-dof the adjacent recut hole set2166a-dby a linear distance generally along the distal-proximal axis. For example, according to the embodiment depicted inFIG.58A, the recut holes2168aof the first recut hole set2166aare linearly offset from the recut holes2168bof the second recut set2166bby a linear distance in the general direction of the distal-proximal axis by a first linear distance (as represented by “D1” inFIG.57). The linear distance of such an offset between each of the adjacent recut hole sets2166a-dcan generally be the same, or alternatively, can vary. Further, according to certain embodiments, the offset distance between one or more of the recut hole axes2170a-dcan generally correspond to the thickness of resection to the next implant thickness.

Thus, according to the illustrated embodiment, as the non-implant-specific pin holes, in this example, recut holes2168a-din each set of recut hole sets2166a-d, of the femoral recut cutting block2164are compatible with at least the recut holes2114a,2114bof the femoral cutting block2100that, unlike the femoral recut cutting block2164, was designed for the implant system being implanted, the femoral recut cutting block2164can be identified as a suitable alternative femoral recut cutting block. For example,FIG.58Cillustrates an example of a graphical display on a display of a plurality of surgeon selectable alternative femoral recut cutting blocks (viz. “GII”, “JOURNEY”, and “TC-PLUS”) that, despite being designed for use with other knee implant systems, have non-implant-specific pin holes that are compatible with similar non-implant-specific pin holes of the knee system that is being implanted. Thus, each of these alternative femoral recut cutting blocks, which, again, may be associated with knee implant systems that are different from the knee implant system that is being implanted, may be deemed suitable for use with the particular knee implant system that is being implanted, and thereby provide a variety of options of femoral recut cutting blocks, and their associated designs, that could be selected by the surgeon for use during an implantation procedure. Further, to the extent that the selected alternative femoral recut cutting block may need to also include patient specific pin holes, such as, for example, the above-discussed paddle holes2114c,2114d, the selected alternative femoral recut cutting block could be adjusted, manufactured, or otherwise provided to also include those implant-specific recut pin holes.

FIGS.59A and59Billustrate anterior and distal views, respectively, of an exemplary tibial recut cutting block2174that is designed for an implant knee system that is different from the knee implant system for which the tibial cutting block2102depicted inFIGS.51,55A and55Bis designed. Similar to the above-discussed femoral recut cutting block2164, according to the illustrated example, the tibial recut cutting block2174has a plurality of sets of non-implant-specific pin holes having configurations that are each similar to, or compatible with, the corresponding configuration of the non-implant-specific pin holes of the tibial cutting block2102. Moreover, in the illustrated example, the tibial recut cutting block2174has three recut hole sets2176a-c, each set having at least two recut holes2178a-cthat extend through an anterior face portion2177of the tibial recut cutting block2174. Further, the recut holes2178a-cin each recut hole set2176a-chave a relative configuration similar to, or compatible with, the configuration of the non-patient-specific pin holes of at least the tibial cutting block2102depicted inFIGS.51,55A and55B, and more specifically, the configuration of the recut holes2152a,2152bof the illustrated tibial cutting block2102. Thus, in the illustrated example, each set of the recut holes2178a-cin the tibial recut cutting block2174is arranged in a manner that is compatible with the configuration, such as the relative location and/or orientation, of the recut holes2156that are, or are to be, formed in the femur2106, as well as the associated location and/or orientation of the pins2157that are (or are to be) inserted therein.

For example, the tibial recut cutting block2174depicted in at leastFIG.59Ahas a first recut hole set2166acomprising a pair of recut holes2168athat have a configuration relative to each other that is similar to the configuration of the recut holes2152a,2152bof the tibial cutting block2102depicted inFIGS.51,55A and55B. Similarly, the illustrated tibial recut cutting block2174also includes second and third recut sets2166b,2166c, each set2166b,2166calso comprising a pair of recut holes2168b,2168chaving a configuration that corresponds to the configuration of the recut holes2152a,2152bof the tibial cutting block2102depicted inFIGS.51,55A and55B. Thus, according to such an embodiment, similar to the recut holes2152a,2152bof the tibial cutting block2102, the recut holes2168a-cof any of the recut hole sets2166a-cof the depicted tibial recut cutting block2174can be generally aligned and/or positioned at the same location relative to the corresponding recut holes2156in the tibia2106.

Additionally, in the illustrated example, each recut hole set2176a-cis generally aligned along an axis2180a-c, each axis2180a-cbeing offset from the axis2180a-cof the adjacent recut hole set2176a-cby a linear distance generally along a distal-proximal axis. For example, according to the embodiment depicted inFIG.59A, the recut holes2178aof the first recut hole set2176aare linearly offset from the recut holes2178bof the second recut set2176bby a linear distance in the distal-proximal axis by a linear distance (as represented by “D2” inFIG.59A). The linear distance of such an offset between each of the adjacent recut hole sets2176a-ccan generally be the same, or alternatively, can vary. Further, according to certain embodiments, the offset distance between one or more of the recut hole axes2180a-ccan generally correspond to the thickness of resection to the next implant thickness.

Thus, according to the illustrated embodiment, as the non-implant-specific pin holes, in this example recut holes2178a-cin each set of recut hole set2176a-c, of the tibial recut cutting block2174are compatible with the recut holes2152a,2152bof the tibial cutting block2102that, unlike the tibial recut cutting block2174, was designed for the implant system being implanted, the tibial recut cutting block2174can be identified as a suitable or compatible alternative tibial recut cutting block. For example,FIG.58Cillustrates an example of a plurality of alternative tibial recut cutting blocks (viz. “GII MIS”, “JNY MIS”, “GII TAA”, “JNYII MIS”, and “PLUS TAA”) that, despite being designed for use with other knee implant systems, have non-implant-specific pin holes having a configuration(s) that is/are compatible with similar non-implant-specific pin holes of the knee system that is being implanted. Thus, each of these alternative tibial recut cutting blocks, which, again, may be associated with knee implant systems that are different from the knee implant system that is being implanted, may be deemed suitable for use with the particular knee implant system that is being implanted, and thereby provide a variety of options of tibial recut cutting blocks, and their associated designs, that could be selected for use by the surgeon for implantation. Further, to the extent that the selected alternative tibial recut cutting block may need to also include patient specific pin holes, such as, for example, the above-discussed paddle holes2152c,2152d, the selected tibial recut cutting block could be adjusted, manufactured, or otherwise provided to also include those implant-specific recut pin holes.

There is provided a method comprising prompting, by a graphical user interface presented on a display device of a computing system, a surgeon for a plurality of adaptive tibial guide parameters collectively indicative of a physical structure of a surgeon-specific tibial cutting guide and a plurality of adaptive femoral guide parameters collectively indicative of a physical structure of a surgeon-specific femoral cutting guide for a surgical procedure on a patient, receiving, via the graphical user interface of the computing system, surgeon input from the surgeon associated with the plurality of adaptive tibial guide parameters and the plurality of adaptive femoral guide parameters, and transmitting, via a communication circuitry of the computing system, the received surgeon input to an instrumentation manufacturing system for manufacturing of at least one of the surgeon-specific tibial cutting guide and the surgeon-specific femoral cutting guide.

In some embodiments, the method may further comprise fabricating the surgeon-specific tibial cutting guide using fabrication machinery of the instrumentation manufacturing system.

In some embodiments, the method may further comprise fabricating the surgeon-specific femoral cutting guide using fabrication machinery of the instrumentation manufacturing system.

In some embodiments, the method may further comprise validating the surgeon input to confirm that the plurality of adaptive tibial guide parameters and the plurality of adaptive femoral guide parameters desired by the surgeon are consistent with an anatomy of the patient.

In some embodiments, prompting the surgeon for the plurality of adaptive tibial guide parameters and the plurality of adaptive femoral guide parameters may comprise separately prompting the surgeon for the plurality of adaptive tibial guide parameters and prompting the surgeon for the plurality of adaptive femoral guide parameters.

In some embodiments, prompting the surgeon for the plurality of adaptive tibial guide parameters and the plurality of adaptive femoral guide parameters may comprise prompting the surgeon to select from a distal cut first surgical sequence or a tibial cut first surgical sequence.

In some embodiments, prompting the surgeon for the plurality of adaptive tibial guide parameters and the plurality of adaptive femoral guide parameters may comprise prompting the surgeon to select from a surgeon-specific tibial cutting guide having at least one contact extension to a tibial paddle relative to a standard surgical cutting guide or a surgeon-specific tibial cutting guide without the at least one contact extension.

In some embodiments, the at least one contact extension may be separable from a remainder of the tibial paddle.

In some embodiments, prompting the surgeon for the plurality of adaptive tibial guide parameters and the plurality of adaptive femoral guide parameters may comprise prompting the surgeon to select a thickness of a cutting blade of a cutting instrument to be used with the surgeon-specific tibial cutting guide.

In some embodiments, prompting the surgeon for the plurality of adaptive tibial guide parameters and the plurality of adaptive femoral guide parameters may comprise prompting the surgeon to select from a surgeon-specific tibial cutting guide that is designed for use with a surgical technique in which an alignment rod is aligned parallel to a mechanical axis of the patient's tibia to gauge alignment or a surgeon-specific tibial cutting guide that is designed for use with a surgical technique in which the alignment rod is aligned perpendicular to a cutting slot of the surgeon-specific tibial cutting guide.

In some embodiments, prompting the surgeon for the plurality of adaptive tibial guide parameters and the plurality of adaptive femoral guide parameters may comprise prompting the surgeon to select from a surgeon-specific tibial cutting guide having a least one rimmed pinhole or a surgeon-specific tibial cutting guide without the at least one rimmed pinhole.

In some embodiments, prompting the surgeon for the plurality of adaptive tibial guide parameters and the plurality of adaptive femoral guide parameters may comprise prompting the surgeon to select from a surgeon-specific tibial cutting guide having at least one bicruciate ligament sparing feature or a surgeon-specific tibial cutting guide without the at least one bicruciate ligament sparing feature.

In some embodiments, prompting the surgeon for the plurality of adaptive tibial guide parameters and the plurality of adaptive femoral guide parameters may comprise prompting the surgeon to select at least one preferred standard surgical recut guide.

In some embodiments, prompting the surgeon for the plurality of adaptive tibial guide parameters and the plurality of adaptive femoral guide parameters may comprise prompting the surgeon to select from a surgeon-specific tibial cutting guide having at least one tibial paddle that extends distal to a cut plane of a cutting instrument to contact a proximal surface of the patient's tibia or a surgeon-specific tibial cutting guide with no tibial paddle that extends distal to the cut plane.

In some embodiments, prompting the surgeon for the plurality of adaptive tibial guide parameters and the plurality of adaptive femoral guide parameters may comprise prompting the surgeon to select from a surgeon-specific femoral cutting guide having a least one rimmed pinhole or a surgeon-specific femoral cutting guide without the at least one rimmed pinhole.

There is also provided a system, comprising a computing device having a communication circuitry, at least one input/output device, a processor, and a memory, wherein the memory comprises a plurality of instructions stored thereon that, in response to execution by the processor, causes the computing device to prompt, via a graphical user interface presented on the input/output device, a surgeon for a plurality of adaptive tibial guide parameters collectively indicative of a physical structure of a surgeon-specific tibial cutting guide and a plurality of adaptive femoral guide parameters collectively indicative of a physical structure of a surgeon-specific femoral cutting guide for a surgical procedure on a patient, receive, via the input/output device, surgeon input from the surgeon associated with the plurality of adaptive tibial guide parameters and the plurality of adaptive femoral guide parameters, and transmit, via the communication circuitry, the received surgeon input to an instrumentation manufacturing system for manufacturing of at least one of the surgeon-specific tibial cutting guide and the surgeon-specific femoral cutting guide.

In some embodiments, the system may further comprise the instrumentation manufacturing system configured to receive the surgeon input, and fabrication machinery that fabricates at least one of the surgeon-specific tibial cutting guide or the surgeon-specific femoral cutting guide.

In some embodiments, the instrumentation manufacturing system may comprise a server configured to receive the surgeon input and transmit instructions to the fabrication machinery for fabrication of the at least one of the surgeon-specific tibial cutting guide or the surgeon-specific femoral cutting guide based on the surgeon input.

There is also provided one or more machine-readable storage media comprising a plurality of instructions stored thereon that, in response to execution by a computing device, causes the computing device to prompt a surgeon for a plurality of adaptive tibial guide parameters collectively indicative of a physical structure of a surgeon-specific tibial cutting guide and a plurality of adaptive femoral guide parameters collectively indicative of a physical structure of a surgeon-specific femoral cutting guide for a surgical procedure on a patient, receive surgeon input from the surgeon associated with the plurality of adaptive tibial guide parameters and the plurality of adaptive femoral guide parameters, and transmit the received surgeon input to an instrumentation manufacturing system for manufacturing of at least one of the surgeon-specific tibial cutting guide and the surgeon-specific femoral cutting guide.

There is a provided herein a method that includes obtaining, using an imaging device, one or more bone images of a bone, and modeling, using at least the one or more bone images, a virtual visualization of the bone. The method can also include analyzing, virtually, one or more bone cuts at one or more locations along the virtual visualization of the bone, and selecting, based at least in part on the analysis of the one or more bone cuts, a bone cut location for cutting the bone. Additionally, a bone cutting block, such as, for example, an adaptive guide, can be built using at least information from the selected bone cut location.

According to some embodiments, the analysis of the one or more bone cuts can comprise evaluating at least one of a size and a shape of the bone at the one or more bone cut locations. Further, the method can also include determining a location of an eminence indicator for the bone cutting block. Additionally, according to certain embodiments, the method can further include analyzing, virtually, one or more insertion locations of one or more ligaments along the bone. Further, the one or more insertion locations can include insertion locations along a tibial eminence of the bone. The method can also include analyzing compromises between at least one of the size and shape of the bone at the one or more bone cut locations and one or more characteristics of the one or more ligaments at the one or more bone cut locations. Additionally, the method can further include performing, virtually, at least a portion of an implant procedure using at least the virtual visualization of the bone and a virtual representation of a tool or component of an implant system.

There is also provided herein is an apparatus that includes a medial tibial paddle that is configured to overly at least a portion of a medial plateau of a bone, and a lateral tibial paddle that is configured to overly at least portions of a lateral plateau of the bone. The apparatus can also include an eminence indicator that is positioned within between the medial and lateral tibial paddles. The eminence indicator can have a plurality of walls that are positioned to identify a plurality of eminence corners for an eminence cut of the bone.

According to some embodiments, the eminence indicator can comprise a medial wall and a lateral wall, the medial wall and the lateral wall being positioned to define a width of a tibial eminence of the bone that is to be retained by the eminence cut. Further, the eminence indicator can include a first arm and a second arm. At least a first wall portion of both the first and second arms can be positioned to define an ending location of the tibial eminence of the bone that is to be retained by the eminence cut. Additionally, the medial wall can be approximately parallel to the lateral wall, while the medial wall and the lateral wall can be approximately perpendicular to the first wall portion of both the first and second arms.

Further, according to some embodiments, an inner sidewall of the medial tibial paddle can be positioned at a location that corresponds to an internal-external rotation of a tibial eminence of the bone. Additionally, the apparatus can further define a cutting slot that extends through at least a portion of the apparatus, and which is sized to guide a displacement of a cutting blade. The apparatus can also include a datum block that is positioned distally of the cutting slot, the datum block having one or more datum pin holes and is configured to establish a plane parallel to a plane of the cutting slot.

Additionally, according to some embodiments, at least one of the medial tibial paddle and the lateral tibial paddle includes a removable paddle extension. Further, at least one of the medial tibial paddle and the lateral tibial paddle can have a pin hole and a guide boss, the guide boss having a boss body, a neck portion, and a removable capture portion. The neck portion can couple the boss body to the removable capture portion, and can have a smaller wall cross-sectional thickness than the boss body and the removable capture portion.

There is also provided an apparatus that includes a paddle section having at least two paddles, the at least two paddles configured to overlay at least an end portion of a bone. The paddle section can also include an eminence indicator that is positioned between the at least two paddles, the eminence indicator having a plurality of walls positioned to identify a plurality of eminence corners for an eminence cut of the bone. The apparatus can also include an alignment section positioned distally of the paddle section, at least a portion of the alignment section defining a cutting slot sized to receive a cutting blade. Additionally, the apparatus can include a datum block that is positioned distally of the alignment section, the datum block having one or more datum pin holes and is configured to establish a plane parallel to a plane of the cutting slot.

According to some embodiments, the alignment section further includes an orientation stylus pin hole positioned to align with a hole in the bone that receives a pin for an orientation stylus. Further, according to some embodiments, at least one of the at least two paddles includes a removable paddle extension.

Additionally, according to some embodiments, at least one of the at least two paddles includes a pin hole and a guide boss, the guide boss having a boss body and a removable capture portion, the guide boss having a boss body, a neck portion, and a removable capture portion. The neck portion can couple the boss body to the removable capture portion, and can have a smaller wall cross-sectional thickness than the boss body and the removable capture portion.

There is provided a method that includes identifying, for selection, a plurality of different implant systems for implantation into a patient, and identifying, for use with the selected implant system, a plurality of preparatory tools, one of more of the identified plurality of implant tools not being specific to the selected implant system.

According to certain embodiments, the method can further include at least one of selecting one of the plurality of different implantation systems, and selecting one of the one or more identified plurality of implant tools that is not specific to the selected implant system. Additionally, according to certain embodiments, the method can also include building the selected one of the plurality of implant tools, and modifying at least one feature of the selected one of the plurality of implant tools to conform to a similar feature of the selected implant system. Further, according to certain embodiments, the plurality of different implantation systems can include a plurality of different models, brands, and/or manufacturers of knee implant systems, and wherein the preparatory tools are cutting blocks that are specific to one or more of the knee implant systems.

There is also provided a method that includes identifying a first non-implant-specific pin hole configuration of a first implant system and identifying a second non-implant-specific pin hole configuration of a second implant system, the first implant system being different from the second implant system. Further, a compatibility of the first non-implant-specific pin hole configuration with the second non-implant-specific pin hole configuration can be determined. If the first and second non-implant-specific pin hole configurations are determined to be compatible, then the method can further include providing a preparatory tool having one or more pin holes having the second non-implant-specific pin hole configuration for implantation of the first implant system.

According to some embodiments, the preparatory tool can comprise, for example, a cutting block, and the first implant system and the second implant system can be each knee implant systems. Further, the first non-implant-specific pin hole configuration and the second non-implant-specific pin hole configuration can both comprise at least one recut hole configuration. Additionally, the cutting block can be a recut cutting block. Further, the difference between the first implant system and the second implant system can comprise a difference in at least one of the following: model, brand, and manufacturer.

Additionally, according to some embodiments, the first implant system can include a preparatory tool having one or more pin holes having the first non-implant-specific pin hole configuration, and the preparatory tool of the first implant system can have a different configuration than the preparatory tool of the second implant system.

There is also provided a method that includes selecting, based on a compatibility with a non-implant-specific pin hole configuration of a first implant system, a cutting block of a second implant system, the second implant system being a different type of implant system than the first implant system. Further, using at least in part pin holes having the non-implant-specific pin hole configuration, a cutting block of the first implant system can be secured to a bone at a first bone location. The method can also include securing, using at least in part pin holes having the non-implant-specific pin hole configuration, the cutting block of the second implant system to the bone generally at the first bone location.

Additionally, according to some embodiments. the non-implant-specific pin hole configuration of the first implant system can be a recut pin hole configuration, and the second cutting block can be a recut cutting block. Further, the recut cutting block can comprise a plurality of sets of recut pin holes, each of the plurality of sets of recut pin holes having the non-implant-specific pin hole configuration. Additionally, the cutting block of the first system and the recut cutting block of the second system can have different sizes. Additionally, the step of selecting the cutting block of the second implant system can include the step of displaying, on a display and for selection, at least the second cutting block. Further, the difference in type can comprise a difference in at least one of the following: model, brand, and manufacturer.

Additionally, there is also provided a method that includes identifying a non-implant-specific pin hole configuration of a first implant system, the non-implant-specific pin hole configuration configured to receive one or more pins that assist in operably securing at least one preparatory tool of the first implant system having the non-implant-specific pin hole configuration at a first bone location of a bone. Further, one or more other implant systems having a non-implant-specific pin hole configuration compatible with the non-implant-specific pin hole configuration of the first implant system can also be identified, the non-implant-specific pin hole configuration of the one or more other implant systems being configured to receive one or more pins that assist in operably securing at least one preparatory tool of the one or more other implant systems at the first bone location. Further, the at least one preparatory tool of the one or more implant systems can have a different configuration than the at least one preparatory tool of the first implant system. The method can also include displaying, on a display and for selection, the at least one preparatory tool of the identified one or more implant systems having the non-implant-specific pin hole configuration.

Additionally, according to certain embodiments, the method can also include selecting, from the displayed at least one preparatory tool, a preparatory tool of the identified one or more implant systems, and securing the selected preparatory tool of the one or more implant systems at the first bone location during implantation of the first implant system.

Further, according to certain embodiments, the first implant system can be a first knee implant system, and the one or more other implant systems can be one or more other knee systems that are either a different model or brand than the first knee implant system. Additionally, the non-implant-specific pin holes of the first implant system can comprise a plurality of recut holes of a cutting block, and wherein the one or more non-implant-specific pin holes of the one or more other implant systems can comprise a plurality of recut holes of one or more recut cutting blocks. The cutting block can be at least one of a femoral cutting block and a tibial cutting block, and the one or more recut cutting blocks can be at least one of a femoral recut cutting block and a tibial recut cutting block. Additionally, the at least one preparatory tool of the one or more other implant systems can include at least one preparatory tool having a plurality of non-implant-specific pin hole configurations, each of the plurality of non-implant-specific pin hole configurations being compatible with the non-implant-specific pin hole configuration of the first implant system.

While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment(s), but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims, which scope is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures as permitted under the law. Furthermore, it should be understood that while the use of the word preferable, preferably, or preferred in the description above indicates that feature so described may be more desirable, it nonetheless may not be necessary and any embodiment lacking the same may be contemplated as within the scope of the invention, that scope being defined by the claims that follow. In reading the claims it is intended that when words such as “a,” “an,” “at least one” and “at least a portion” are used, there is no intention to limit the claim to only one item unless specifically stated to the contrary in the claim. Further, when the language “at least a portion” and/or “a portion” is used the item may include a portion and/or the entire item unless specifically stated to the contrary.