Customized patient-specific orthopaedic surgical instrumentation

ES 2 556 909 T3

Customized, patient-specific orthopedic surgery instruments

Description

TECHNICAL FIELD

[0001] The present disclosure relates generally to custom patient-specific orthopedic surgical instruments, and to methods, devices, and systems for fabricating and positioning such instruments.

BACKGROUND

[0002] Joint arthroplasty is a well known surgical procedure whereby a damaged or diseased natural joint is replaced by a prosthetic joint. A typical knee prosthesis includes a tibial tray, a femoral piece, a polymeric graft or support located between the tibial tray and the femoral piece, and, in some cases, a polymer patellar button. To facilitate the replacement of the natural joint with the knee replacement, orthopedic surgeons use a variety of orthopedic surgical instruments such as cutting boards, drill guides, drill guides, and other surgical instruments. Orthopedic surgical instruments are typically generic as far as the patient is concerned, so that the same orthopedic surgical instrument can be used with different patients during similar orthopedic surgical procedures.

[0003] WO-A-2007/097854, on which the preamble of claim 1 is based, provides a personalized and patient-specific arthroplasty template, in addition to the method for its manufacture.

RESUME

[0004] The invention provides a personalized and patient-specific orthopedic instrument, as explained in claim 1.

[0005] Optional features of the invention are specified in the dependent claims.

[0006] A method is provided for performing an orthopedic surgical procedure on the bone of a patient. The method may include placing a custom, patient-specific cutting board in contact with the patient's bone. The method may include placing the patient-specific custom cutting board in contact with a patient's femur. The method may include placing the patient-specific custom cutting board in contact with a patient's tibia. The method may include inserting a pair of guide pins into a pair of guide pin holes specified in the patient-specific, custom cutting board. The method may also include making a first cut in the patient's bone with the custom, patient-specific cutting board. The method may also involve making the first cut in the patient's femur with the custom, patient-specific cutting board. If not, the method may involve making the first cut in the patient's tibia with the custom, patient-specific cutting chart. The method may also involve the patient-specific, custom cutting board being removed from the patient's bone without removing the guide pins from the patient's bone.

[0007] The method may involve inserting the pair of guide pins into a designated pair of guide pin holes in a universal patient cutout board and a second cut is made in the patient's bone with the suitable cutout table. for all types of patients. The method can lead to the second cut being made in the patient's femur with the trimmed board suitable for all types of patients. The method may also involve making the second cut in the patient's femur essentially parallel to the first cut. Additionally, the method may involve the second cut in the femur being made at an angle to the first cut.

[0008] The method can lead to the second cut being made in the tibia of the patient using the trimmed table suitable for all types of patients. The method may also involve making the second cut in the patient's tibia essentially parallel to the first cut. Additionally, the method may involve the second cut in the tibia being made at an angle to the first cut.

[0009] The method may involve inserting the pair of guide pins into a pair of guide pin holes marked on the cutting board for all types of patients, such that a cutting guide of the cutting board suitable for all types of patients is basically parallel to the first cut. The method may involve making the second cut in the patient's bone with the cutting board suitable for all types of patients, in such a way that the second cut is basically parallel to the first cut. The method may also involve making the second cut in the patient's femur essentially parallel to the first cut. Additionally, the cutting guide of the all-patient cutting board can be oriented at an angle to the first cut. The method may entail that the second cut in the patient's bone is made with the cutting board suitable for all types of patients, in such a way that the second cut is oriented at a position that forms an angle with respect to the first cut.

[0010] The method may involve determining the amount of additional bone to be removed from the patient's bone after the first cut has been made in the patient's bone using the patient-specific and personalized cutting table. The method may lead to a pair of holes being chosen

ES 2 556 909 T3 for guide pins between the numerous guide pin holes outlined in the all-patient cutting board, which corresponds to the amount of additional bone to be removed from a patient's bone. The method may involve inserting the guide pin pair into the previously chosen guide pin holes marked on the All-Patient Cutting Table, corresponding to the amount of additional bone to be removed. of a patient's bone.

[0011] A method is provided for performing an orthopedic surgical procedure on the femur of a patient. The method may involve a custom, patient-specific cutting board being placed or positioned in contact with the patient's femur and a pair of guide pins being inserted into a pair of guide pin holes indicated on the guide table. personalized and patient-specific cut. The method may also involve making a first cut in the patient's femur using the custom, patient-specific cutting table. The method may involve the patient-specific custom cutting board being removed without removing the guide pins from the patient's femur. The method may also involve determining the amount of additional bone to be removed from the patient's femur after the first cut in the femur has been made, and choosing a pair of guide pin holes from among the numerous Guide pin holes marked on an all-patient cutting board, corresponding to the amount of additional bone to be removed from the patient's femur.

[0012] Furthermore, the method may involve inserting the pair of guide pins into the pair of guide pin holes indicated in the cutting board suitable for all types of patients, which corresponds to the amount of additional bone that It must be removed from the patient's femur. The method may involve making a second cut in the patient's femur with the cutting board suitable for all types of patients. The method may involve inserting the pair of guide pins into the selected pair of guide pin holes such that a cutting guide of the cutting board suitable for all types of patients is basically parallel to the first cut. The method may involve making the second cut in the patient's femur with the cutting board suitable for all types of patients in such a way that the second cut is basically parallel to the first cut. Additionally, the method may involve inserting the guide pin pair into the selected guide pin pair of holes such that an all-patient cutting board cutting guide is oriented in the same direction. a position that forms an angle with respect to the first cut. The method may involve making the second cut in the patient's femur with the cutting board suitable for all types of patients in such a way that the second cut is oriented at an angle to the first cut.

[0013] A method is provided for performing an orthopedic surgical procedure on the bone of a patient. The method may involve driving a leading end of one or more surgical guide pins into the bone of the patient. The method may also involve leading a second end of the surgical guide pin (s) forward into a guide attached to a bone saw, such that the bone saw is positioned in a predetermined position relative to the patient's bone. The method may involve making a cut in the patient's bone using the bone saw while one or more surgical guide pins are in place in the guide.

[0014] The guide may consist of a body with one or more designated openings. The method may involve the second end of one or more surgical guide pins being accommodated in one or more of the openings in the guide body. Additionally, the guide may include an elongated body with a slot. The method may involve the second end of one or more surgical guide pins being accommodated in the slot in the elongated body of the guide.

The bone saw may include a bone saw blade attached to a collet and a pivot pin (or rotary pivot) located between the collet and the guide. The method may involve the forceps being rotated relative to the guide while the cut is being made in the patient's bone.

[0016] The method may involve placing a patient-specific, personalized cutting board in contact with the patient's bone. The method may also involve the leading end of one or more guide pins being inserted through one or more guide pin holes that are marked on the patient-specific custom cutting board, and being driven into the the patient's bone. In addition, the method may involve the patient-specific, customized cutting board being removed from the patient's bone, all without removing the surgical guide pin (s) from the patient's bone.

[0017] A method is provided for performing an orthopedic surgical procedure on a bone of a patient. The method may involve inserting an anterior piece of a patient-specific, custom cutting board through an incision. The method may also involve inserting a patient-specific, customized back piece of the cutting board through an incision; the back piece is separated from the front piece. The method may entail that, after being inserted, the anterior piece is secured to the posterior piece to create a custom, patient-specific cutting board already assembled. The front piece and the back piece can be attached using multiple pins.

[0018] The method may involve the custom, patient-specific cutting board already assembled being placed in contact with the patient's bone and a cut is made in the patient's bone with the custom, patient-specific cutting board. patient already assembled. The method may result in the assembled, patient-specific custom cutting board being placed in contact with the patient's femur. The method may also involve cutting the patient's femur with the custom, patient-specific cutting board already assembled. Additionally, the method may involve the custom, patient-specific cutting board already assembled being placed in contact with the patient's tibia. The method may also involve cutting the patient's tibia with the custom, patient-specific cutting board already assembled. The method may also mean that before a cut is made

ES 2 556 909 T3 into the patient's bone, a pair of guide pins are inserted into a pair of guide pin holes outlined on the assembled patient-specific custom cutting board.

[0019] A method is provided for performing an orthopedic surgical procedure on a bone of a patient. The method may involve securing a patient-specific, customized cutting board to the patient's bone, such that the anterior portion of the patient's bone is accommodated on the patient-specific, customized anterior negative surface of the cutting board, and in such a way that the distal part of the patient's bone is housed in the distal negative surface - personalized and specific for the patient - of the cutting board. The method may involve making an anterior cut in the patient's bone using the cutting board, such that a flat surface is formed in the anterior part of the patient's bone; and that a distal cut is made in the patient's bone using the cutting board, such that a flat surface is formed on the distal portion of the patient's bone. The method may also involve determining the amount of additional bone to be removed from the patient's bone after the anterior cut and the distal cut have been made in the patient's bone.

[0020] The method may involve the patient-specific, personalized cutting board being secured to the patient's bone; thus, the flat surface that is formed on the anterior portion of the patient's bone is positioned against at least one flat surface formed on an anterior surface of the cutting board that faces the bone; and furthermore, the flat surface that is formed on the distal portion of the patient's bone is positioned against at least one flat surface formed on a distal surface of the cutting board that faces the bone. Furthermore, the method may involve making at least one additional anterior cut in the patient's bone using the cutting board, such that the additional amount of bone is removed from the flat surface formed in the anterior part of the patient's bone. ; and that at least one additional distal cut is made in the patient's bone using the cutting board, such that the amount of additional bone is removed from the flat surface formed in the distal portion of the patient's bone.

[0021] The method may involve the patient-specific, personalized cutting board being secured to the patient's femur, such that the anterior portion of the patient's femur is accommodated on the patient-specific, personalized anterior negative surface. - of the cutting board, and in such a way that the distal part of the patient's femur is housed in the distal negative surface - personalized and specific for the patient - of the cutting board. The method may involve making both an additional anterior cut in the patient's bone using the cutting board - such that the amount of additional bone is removed from the flat surface formed in the anterior part of the patient's bone - and a Additional distal cut into the patient's bone using the cutting board - such that the amount of additional bone is removed from the flat surface formed in the distal portion of the patient's bone.

[0022] A method is provided for performing an orthopedic surgical procedure on a patient. The method may involve a custom, patient-specific femoral cutting board being secured to the patient's femur, and a ligament balancer being secured to the patient's tibia. The method may involve securing the ligament balancer to the custom, patient-specific femoral cutting board. The method can also involve the ligament balancer being manipulated to position the patient's femur in the desired position relative to the tibia. Additionally, the method may involve cutting the patient's femur with the custom, patient-specific cutting board.

[0023] Securing the patient-specific, personalized femoral cutting board may result in placing the patient-specific, personalized femoral cutting table in contact with the patient's femur. The method may also involve inserting at least one guide pin into at least one guide pin hole designated on the patient-specific, customized femoral cutting board in such a way that the guide table is secured to the patient's femur. customized and patient-specific femoral cut.

[0024] The method may involve the ligament balancer having the leading end of a bracket attached thereto. The secondary end of the bracket may be designated at least one hole for guide pins. The method may also involve at least one guide pin being accommodated in at least one guide pin hole located in the holder, such that the secondary end of the holder is secured to the custom and specific femoral cutting board. patient. Additionally, the method may involve each of the two femoral blades of the ligament balancer moving independently.

[0025] The method of performing an orthopedic surgery procedure on a patient's knee may involve securing a patient-specific, personalized cutting board to the patient's knee, such that a portion of a femur of the patient is housed on a surface -located in front of the femur- that has a personalized negative relief specific to the patient; and in such a way that a part of a patient's tibia is housed on a surface -located in front of the tibia- that has a personalized and specific negative relief for the patient. The method may also involve making a cut in at least one tibia of the patient and the femur of the patient using the customized and patient-specific cutting table. The method may involve making a cut in the patient's femur using the custom, patient-specific cutting table. The method may involve making a cut in the patient's tibia using the custom, patient-specific cutting table.

[0026] The method may involve inserting a guide pin through a tibial guide pin hole and into the tibia of the patient. The method may involve inserting a guide pin through a femoral guide pin hole and into the patient's femur.

[0027] The methods for carrying out surgical procedures that have been described above do not form part of the invention.

ES 2 556 909 T3

BRIEF DESCRIPTION OF THE ILLUSTRATIONS

The detailed description refers in particular to the following figures, in which:

FIG. 1 is a simplified flow chart that refers to an algorithm for designing and manufacturing a patient-specific, customized orthopedic surgery instrument.

FIG. 2 is a simplified flow chart relating to a method of generating a model of a patient-specific, customized orthopedic surgery instrument.

FIG. 3 is a simplified flow chart referring to a method of defining the scale of a reference relief or contour.

FIGS. 4-6 are three-dimensional models of a patient's tibia.

FIGS. 7 through 9 are three-dimensional models of a patient's femur.

FIG. 10 is an elevated view of a customized, patient-specific orthopedic surgery instrument. FIG. 11 is a perspective view of the customized, patient-specific orthopedic surgery instrument of FIG. 10.

FIG. 12 is a perspective view of the customized, patient-specific orthopedic surgery instrument of FIG. 10, secured to a bone of the patient.

FIG. 13 is an anterior elevated view of another patient-specific, customized orthopedic surgical instrument.

FIG. 14 is an overall top view of the custom patient-specific orthopedic surgery instrument of FIG. 13.

FIG. 15 is a side elevation view of the customized, patient-specific orthopedic surgery instrument of FIG. 13.

FIG. 16 is an anterior elevated view of another patient-specific, customized orthopedic surgery instrument.

FIG. 17 is an overview and top view of the customized, patient-specific orthopedic surgery instrument of FIG. 16.

FIG. 18 is a side elevation view of the customized, patient-specific orthopedic surgery instrument of FIG. 16.

FIG. 19 is a simplified block diagram referring to a milling machine for fabricating patient-specific, customized orthopedic surgical instruments.

DETAILED DESCRIPTION OF THE ILLUSTRATIONS

[0029] In FIG. 1, an algorithm 10 for fabricating patient-specific and customized orthopedic surgery instruments is illustrated. The term "patient-specific and personalized orthopedic surgery instrument" refers to a surgical tool that is available to the surgeon for the surgeon to carry out an orthopedic surgery procedure that is intended, and configured, for a patient in particular. Therefore, it should be understood that, as used in this text, the term "patient-specific, personalized orthopedic surgery instrument" is different from standard, non-patient-specific orthopedic surgical instruments, which they are intended for use with a variety of different patients. Additionally, it should be understood that, as used in this text, the term "personalized and patient-specific orthopedic surgery instrument" is different from orthopedic prostheses, whether specific or generic, which are surgically implanted in the patient's body. In fact, patient-specific, customized orthopedic surgery instruments are used by the orthopedic surgeon to assist in implanting orthopedic prostheses.

[0030] The patient-specific, personalized orthopedic surgery instrument can be customized for a particular patient based on the location at which the instrument is to join one or more bones of the patient, such as the femur and / or tibia. For example, the customized, patient-specific orthopedic surgical instrument may include a surface in contact with or facing the bone, and having a negative relief that conforms or substantially conforms to the relief of the relevant portion of the bone. bone of the patient. Thus, the patient-specific, customized orthopedic surgery instrument is configured to engage a patient's bone in a single location and position relative to the patient's bone. That is, the negative relief of the bone-contacting surface is configured to accommodate the corresponding contour surface of the patient's bone portion. Thus, the guesswork and / or decision making that the orthopedic surgeon must make regarding the placement of the orthopedic surgery instrument is reduced. For example, the orthopedic surgeon may not need to locate landmarks on the patient's bone to facilitate placement of the orthopedic surgical instrument, which usually requires the surgeon to estimate. Instead, the orthopedic surgeon will simply have to bring the patient-specific, custom orthopedic surgical instrument together with the patient's bone or bones in a single location. When so joined, the cutting plane, drill holes or holes, drill holes, and / or other guides are marked in the proper location with respect to the bone and the prosthesis to be placed. The custom, patient-specific orthopedic surgery instrument can include the same elements as any type of orthopedic surgery instrument, such as a bone cutting board, drill guide, drill guide, or other types of surgical instruments. surgical surgery that are configured to engage the patient's bone.

ES 2 556 909 T3

[0031] As shown in FIG. 1, algorithm 10 includes process steps 12 and 14, in which an orthopedic surgeon develops a preoperative plan for the orthopedic surgery procedure to be performed on a patient. Steps 12 and 14 can be performed in any order or simultaneously. In step 12, various medical images of the relevant bone or joint anatomy of the patient are generated. To this end, the orthopedic surgeon or another member of the healthcare staff can operate an imaging system to generate the medical images. Medical images can include any number or type of medical images that allow a rendered, three-dimensional model of the patient's relevant bone or joint anatomy to be generated. For example, medical images can include any number of computerized tomography (CT) images, magnetic resonance images, or other three-dimensional medical images. Additionally or alternatively, as explained in more detail below in step 18, medical images may include X-ray images or other two-dimensional images from which a three-dimensional rendered model of the bone anatomy can be generated. relevant to the patient. Additionally, the medical image can be enhanced with a contrast medium or agent designed to enhance the cartilaginous surface of the patient's knee joint.

In step 14, the orthopedic surgeon can determine any additional difficulties or limitations concerning the preoperative data. For this, it can be based on your preferences, on the patient's preferences, on anatomical aspects of the patient, on the guidelines established by the health center or other similar conditions. For example, information or data regarding these difficulties (or restrictive data) may include the orthopedic surgeon's preference to use a metal-to-metal interface, the level of implant inclination, the thickness of the bone to be removed, the orthopedic implant width range and the like. Optionally, orthopedic surgeon preferences are saved in a surgeon profile, which can be used to take default values ​​into account for future surgical plans.

[0033] In step 16, medical images and restrictive data, if any, are communicated or otherwise supplied to a merchant or manufacturer of orthopedic surgery instruments. Medical images or restrictive data can be provided to the merchant by electronic means such as a network (Internet) or the like. After the merchant has received the medical images and restrictive data, they process the images in step 18. Medical imaging is processed by the orthopedic surgery instrument dealer or manufacturer to facilitate bone cutting planes, implant size, and patient-specific custom orthopedic surgery instrument fabrication as described in detail later. For example, in step 20 the merchant can convert or otherwise generate three-dimensional images from medical images. For example, when the medical images include multiple two-dimensional images, the merchant may use a suitable computer algorithm to generate one or more three-dimensional images from the two-dimensional images. Additionally, medical images can be generated from established standards such as the Digital Imaging and Communications in Medicine (DICOM) standard. To do this, an Edge Detection, Threshold Value Method, Divide Transformation algorithm or a memetic algorithm can be used to convert or reconstruct the images to a valid format for a computer-aided design application or other image processing applications. . What's more, an algorithm can be used to represent tissue such as cartilage, which is not perceptible in generated medical images. Any patient-specific three-dimensional model of the instrument (see, for example, step 26 below) can be modified in accordance with the aforementioned algorithms to improve the shape and functions of the instrument.

[0034] In step 22, the merchant can process the medical images, and / or the converted / reconstructed images of step 20, to establish various aspects related to the patient's bone anatomy such as the axis or anatomical plane of the patient's bones , the mechanical axis of the patient's bone, other axes and various landmarks, and / or other aspects of the patient's bone anatomy. To do this, the merchant can use any suitable algorithm to process the images.

In step 24, the cutting planes of the patient's bone are established. Planned cutting planes are determined based on the type, size, and position of the orthopedic prosthesis to be used during the orthopedic surgery procedure, based on the images processed and their specific landmarks, and based on restrictive data provided by the orthopedic surgeon. in steps 14 and 16. The type and / or size of the orthopedic prosthesis can be determined based on the patient's anatomy and restrictive data. For example, restrictive data may condition the type, make, model, size, and other characteristics of the orthopedic prosthesis. The selection of the orthopedic prosthesis can also be modified based on the medical images, such that an orthopedic prosthesis will be selected that can be adapted to the bone anatomy of the patient and that corresponds to the restrictive data or the preferences of the orthopedic surgeon.

[0036] In addition to the type and size of the orthopedic prosthesis, the intended location and position for the orthopedic prosthesis is established according to the bone anatomy of the patient. To do this, a digital template of the selected orthopedic prosthesis can be placed on one or more processed medical images. The merchant can use any suitable algorithm to determine a recommended location and orientation of the orthopedic prosthesis (eg, finger template) relative to the patient's bone, based on processed medical images (eg, landmarks in bone. of the patient indicated in the images) and / or in the restrictive data. Additionally, other aspects of the patient's bone anatomy may be considered to determine the correct positioning of the finger template.

The digital template, along with other adjustable parameters, may be presented to the orthopedic surgeon for approval. The approval document may include the rotation of the implant with respect to bony landmarks such as the femoral epicondyle, posterior condyles, canals or grooves (the line of

ES 2 556 909 T3

Whiteside) and the mechanical axis, defined by the hip, knee and / or central points of the ankle.

[0038] The intended cutting plans for the patient's bone (s) can be established based on the determined size, location and orientation of the orthopedic prosthesis. In addition, other aspects of the patient's bone anatomy, as set forth in step 22, can be used to determine or adjust the anticipated cutting planes. For example, the mechanical axis, landmarks, and / or other determined aspects of the patient's relevant bones can be used to establish the intended cutting planes.

[0039] In step 26, a patient-specific, customized orthopedic surgery instrument model is generated. Optionally, the model is rendered as a patient-specific, custom 3-D rendering of the orthopedic surgery instrument. In other cases, the model can be represented as a replica or rapid prototype of the customized, patient-specific orthopedic surgery instrument. The particular type of orthopedic surgical instrument to be modeled and manufactured can be determined based on the orthopedic surgery procedure to be performed, restrictive data, and / or the type of orthopedic prosthesis to be implanted at the time. patient. Thus, the patient-specific, personalized orthopedic surgery instrument can include any type of orthopedic surgery instrument that is used to perform an orthopedic surgery procedure. For example, the orthopedic surgery instrument may be a bone cutting board, a drill guide, a guide for a milling machine, and / or any other type of orthopedic surgery tool or instrument.

[0040] The particular shape of the personalized and patient-specific orthopedic surgical instrument is determined based on the predicted location of the orthopedic surgical instrument in relation to the bone anatomy of the patient. The location of the personalized and patient-specific orthopedic surgical instrument with respect to the patient's bone anatomy is determined based on the determined type and location of the orthopedic prosthesis to be used during the orthopedic surgery procedure. That is, the intended location of the patient-specific, customized orthopedic surgical instrument in relation to the patient's bone anatomy will be chosen based, in part, on the anticipated cutting planes of the patient's bone (or bones) as stated. in step 24. For example, when the patient-specific custom orthopedic surgery instrument is a bone cutting board, the location of the orthopedic surgery instrument is selected so that the cutting guide on the bone cutting board corresponds to one or more predicted cut planes that are determined in step 24. Additionally, the predicted location of the orthopedic surgical instrument can be based on the patient's bone landmarks identified in step 22.

[0041] Optionally, the particular shape or configuration of the personalized and patient-specific orthopedic surgery instrument can be established based on the predicted location of the instrument in relation to the patient's bone anatomy. That is, the patient-specific, customized orthopedic surgery instrument may include a bone-contacting surface that has a negative relief that conforms to the relief of a portion of the patient's bone anatomy, such that the bone-contacting instrument Orthopedic surgery can be coupled with the patient's bone anatomy in a single location, which corresponds to the location previously foreseen for the instrument. When the orthopedic surgical instrument is joined to the patient's bone anatomy in a single location, one or more guides (for example, a drill or drill guide) of the orthopedic surgical instrument can be aligned with one or more of the planes of cutting the bone, as previously explained.

[0042] In FIGS. 2-9, an enlightening method 40 is illustrated for generating a model - eg, a computer model - of a patient-specific orthopedic instrument. Method 40 begins with a step 42 in which the thickness of the cartilage is determined. The cartilage thickness value is indicative of the average cartilage thickness of a patient's bone. Therefore, the value of the cartilage thickness can be equal to the average thickness of the cartilage of an individual with characteristics similar to those of the patient. For example, the cartilage thickness value may be equal to the average cartilage thickness of individuals of the same gender as the patient, the same age as the patient, having the same activity level as the patient, and / or the like. If not, the cartilage thickness value is determined based on one or more medical images of the patient's bone, such as the images provided in step 16.

In step 44, a reference contour or relief of the relevant bone of the patient is determined. The reference relief is based on the surface contour of a three-dimensional model of the patient's relevant bone, for example, the three-dimensional model generated in step 20. Initially, the reference contour is identical to an area of ​​the patient's bone (eg, an area of ​​interest such as the distal end of the patient's femur or the proximal end of the patient's tibia). Thus, optionally, the reference contour is juxtaposed with the surface contour of the patient's bone area.

Subsequently, in step 46 the reference contour scale has been modified to balance it with the cartilage thickness value determined in step 42. For this, the reference contour scale can be increased based on the thickness value of cartilage. For example, the scale of the reference contour can be increased by an equal or determined value from the value of the thickness of the cartilage. However, the reference contour scale can be modified using other techniques designed to scale the reference contour to a size where the reference contour is balanced by the thickness of the cartilage of the patient's bone.

[0045] For example, in a particular arrangement, the scale of the reference contour is modified by increasing the distance between a fixed reference point and a point that lies on the reference contour and defines it partially. To do this, in one embodiment, a method 60 may be used to scale a reference contour as illustrated in FIG. 3. Method 60 begins with step 62, in which a

ES 2 556 909 T3 medial / lateral segment in the three-dimensional model of the patient's relevant bone. The medial / lateral segment is defined or otherwise selected to extend from a point on the medial surface of the patient's bone to a point on the lateral surface of the patient's bone. The median surface point and the lateral surface point are selected to basically define the maximum local medial / lateral width of the patient's bone.

[0046] In step 64, an anterior / posterior segment is arranged in the three-dimensional model of the relevant bone of the patient. The anterior / posterior segment is defined or otherwise selected to extend from a point on the anterior surface of the patient's bone to a point on the posterior surface of the patient's bone. The anterior surface point and the posterior surface point are selected to basically define the maximum anterior / posterior local width of the patient's bone.

[0047] The reference point from which the scale for the reference contour will be taken is defined in step 66 as the intersection point of the medial / lateral segment and the anterior / posterior segment. Therefore, it should be noted that the intermediate surface point, the lateral surface point, the anterior surface point and the posterior surface point are in the same plane. After the reference point is initially established in step 66, the reference point is moved or shifted toward one end of the patient's bone. For example, when the patient's bone is a femur, the reference point moves downward toward the distal end of the patient's femur. Conversely, when the patient's bone is a tibia, the reference point moves upward toward the proximal end of the patient's tibia. For example, the reference point is moved a distance equal to approximately half the length of the anterior / posterior segment, as set in step 64. However, the reference point can be moved other distances as long as they are sufficient. to balance the reference contour and the thickness of the cartilage present in the patient's bone.

[0048] Once the location of the reference point has been determined in step 68, the distance between the reference point and each point that lies on and partially defines the reference contour is increased (step 70). For this, in a particular embodiment, each point of the reference contour moves away from the reference point based on the percentage value of the original distance, defined between the reference point and the particular point on the reference contour. For example, each point that is on the datum contour, and partially defines it, can move away from the datum point by a distance equal to the percentage value of the original distance between the datum and the particular point. In one embodiment, the percentage value is in a range of about 5% to 30%. In a particular embodiment, the percentage value is approximately 10%.

[0049] With reference to FIGS. 4-9, in another embodiment the reference contour scale is scaled by manually selecting a local "raised" point on the contour of the three-dimensional image surface of the patient's bone. For example, when the relevant bone of the patient is a tibia, as illustrated in FIGS. 4-6, the landmark 90 is initially located at the elevated point of the tibial plateau of the tibial cast 92. Either side of the tibial plateau can be used. Once reference point 90 has initially been set at the high point of the tibial plateau, reference point 90 is moved to the approximate center of the plateau as illustrated in FIG. 5, in such a way that the Z axis that defines the reference point is parallel to the mechanical axis of the tibial model 92. Subsequently, as illustrated in FIG. 6, the reference point is moved distally by a predetermined amount. In a particular embodiment, the reference point moves distally by about 20 millimeters, but other distances can also be used. For example, the distance the landmark is moved can be based on the cartilage thickness value.

[0050] Conversely, when the relevant bone of the patient is a femur, as illustrated in FIGS. 7 through 9, reference point 90 is initially located at the most distal point of the distal end of femoral cast 94. Any condyle of femoral cast 94 may be used. Once reference point 90 is initially set at the most distal point, reference point 90 is moved to the approximate center of the distal end of femoral cast 94, as illustrated in FIG. 8, such that the Z axis defining the reference point 90 is parallel to the mechanical axis of the femoral cast 92. The anterior / posterior width 96 of the distal end of the femoral cast 94 is also determined. Subsequently, as illustrated in FIG. 9, the reference point is moved or displaced a distance 98 in a proximal or superior direction. In a particular embodiment, the reference point is moved or displaced in a proximal or greater direction by a distance 98 equal to approximately half the distance 96. Thus, it should be noted that one of many different techniques can be used to fix the location. of the reference point based, for example, on the type of bone.

[0051] Referring again to FIG. 2, once the datum contour has been scaled in step 46, the medial / lateral sides of the datum contour are adjusted in step 48. To do this, the distance between the datum point and each one of the points that are on the intermediate side and the lateral side - and partially define them - of the reference contour. For example, the distance between the reference point and the points on the middle and lateral sides of the scaled reference contour is optionally reduced to the original distance between those points. Therefore, it should be noted that the reference contour is equalized or, if not, enlarged with respect to the anterior side of the patient's bone, and practically corresponds to the medial and lateral sides of the patient's bone, or is not scaled with respect to to them.

[0052] The reference contour can also be adjusted in step 48 in areas of the patient's bone that have a more reduced cartilage thickness. These areas with reduced cartilage thickness can be determined based on the existence of bone-to-bone contact detected on a medical image, simulation, or the like. Additionally, the orthopedic surgeon can provide relevant information on these areas based on his experience and knowledge. If one or more areas with a reduced thickness of the cartilage are located, the reference contour will be reduced (that is, its scale will be reduced) corresponding to these areas

ES 2 556 909 T3 of the patient's bone.

[0053] Additionally, one or more osteophytes (bone outgrowths) can be identified in the patient's bone, and the reference contour can be balanced with said presence of osteophytes. By compensating for the difference due to these osteophytes, the reference contour more closely corresponds to the contour of the patient's bone surface. In addition, a distal end (when the patient's bone is a tibia) or a proximal end (when the patient's bone is a fibula) of the reference contour can be adjusted to improve the correspondence between the reference contour and the surface contour. of the bone. For example, when the patient's bone is a femur, the upper end of the scaled reference contour can be reduced or, if not, it can be brought closer to the surface contour of the patient's femur in the area located above the cartilage demarcation line. marked on the patient's femur. Conversely, when the patient's bone is a tibia, the lower end of the scaled reference contour may be reduced or, if not, it may approach the surface contour of the patient's tibia in the area located below the demarcation line. of cartilage marked on the patient's tibia. Therefore, it should be noted that the scaled reference contour is initially enlarged to match the thickness of the cartilage in the patient's bone. Subsequently, some areas of the scaled reference contour are reduced or, if not, they are moved to their original positions and / or towards the reference point in those areas where the cartilage is missing, reduced or otherwise not present .

[0054] Once the reference contour has been scaled and adjusted in steps 46 and 48, the position of the cutting guide is defined in step 50. In particular, the position of the cutting guide is defined based on the angle between the mechanical axis of the patient's femur and the mechanical axis of the patient's tibia. The angle can be determined by fixing a segment or line that runs from the proximal end of the patient's femur to the distal end of the patient's femur, and fixing a second segment or line that exits the patient's ankle and passes through the proximal end of the patient's tibia patient. The angle between these two segments / lines is equal to the angle between the mechanical axis of the femur and the tibia of the patient. The position of the bone cutting guide is then determined based on the angle between the mechanical axes of the femur and the patient's tibia. It should be noted that the position of the cutting guide defines the position and orientation of the cutting plane of the customized and patient-specific cutting table. Subsequently, in step 52, a patient-specific personalized cutting board negative contour or relief is defined based on the scaled and adjusted reference contour and the angle between the mechanical axis of the femur and the tibia.

Returning to FIG. 1, after the patient-specific custom orthopedic surgery instrument model has been generated in step 26, the model is validated in step 28. For example, the model can be validated by analyzing the rendered model together with the three-dimensional model of the patient's anatomy to verify the correlation of the cutting guides and planes, the guides for the router and the points for the intended drilling, and / or the like. Additionally, the cast can be validated by transferring or otherwise providing the cast generated in step 26 to the orthopedic surgeon for review. For example, when the model is a 3D rendered model, the model and the 3D images of the patient's relevant bone (or bones) can be sent to the surgeon for review. When the model is a physical prototype, the model can be sent to the orthopedic surgeon for validation.

[0056] After the model has been validated in step 28, the custom, patient-specific orthopedic surgery instrument is fabricated in step 30. The custom, patient-specific orthopedic surgery instrument can be fabricated using any proper manufacturing method and tool. Additionally, the customized and patient-specific orthopedic surgery instrument can be manufactured from any suitable material such as a mechanical material, a plastic material, or a combination of both, depending, for example, on the intended use for the procedure. instrument. Subsequently, the customized and patient-specific orthopedic instrument, already manufactured, is sent or otherwise transferred to the orthopedic surgeon. The surgeon performs the orthopedic surgery at step 32 using the patient-specific custom orthopedic surgical instrument. As previously explained, since the orthopedic surgeon does not need to determine the correct location of the orthopedic surgery instrument intraoperatively, which usually requires the surgeon to make estimates to some extent, guesswork and decisions are reduced. that the orthopedic surgeon must take during the operation.

Referring now to FIGS. 10-12, the patient-specific custom orthopedic surgery instrument may be a femur cutting board 100. The cutting board 100 is configured to engage a patient's femur 124 as illustrated in FIG. 12. The cutting board 100 includes a body 102 configured to mate with the anterior side of the femur 124. Two flanges 104, 106 extend orthogonally from body 102 and are configured to encircle the end of femur 124 as explained in more detail below. Each of the flanges 104, 106 has an inwardly curving edge 108, 110, respectively, and which corresponds to the posterior condyles of the femur. The femur cutting board 100 has a bone-contacting or facing bone surface 112, and is located within the body 102, flanges 104, 106, and edges 108, 110. The contacting surface with bone 112 it has a negative contour 114 configured to accommodate a portion of the patient's bone having a corresponding contour. As previously explained, the negative contour 114 of the bone-contacting surface 112 allows cutting board 100 to be positioned on the patient's bone in a single, predetermined location and orientation.

[0058] Optionally, the bone-contacting surface 112 of the cutting board 100 (as well as each bone-contacting surface analyzed in relation to other structures) may or may not be an exact negative of the bone model. three-dimensional generated from a medical image (see step 26 of the algorithm

ES 2 556 909 T3 previously illustrated and described in connection with FIG. 1). Instead, the surface in contact with the bone may be deviated from the bone model to compensate for the patient's cartilage that may or may not appear on the medical image. Typically, this deviation ranges from about 0.5 millimeters to about 5 millimeters depending on the location, the gender of the patient, and the disease state of the patient's joint. Normally, the cartilage is thickest in areas 112b, 112d, and 112e. It is often fine or non-existent in zones 112a and 112c. Thus, the cutting board for the femur 100 includes various deviations or ranges in its surface in contact with the bone 112.

The cutting board 100 includes a platform 116 for the cutting guides that rises above the body 102. The platform 116 for the cutting guides includes a designated cutting guide 118. Platform 116 also includes a pair of anterior guide pins 120. Tabs 104, 106 are designated with a pair of distal guide pins 121. Optionally, guide pins 118 can be used as drill guides to fix guide pin holes in the patient's femur 124. However, it is not necessary to use guide pins. That is, the cutting board 100 can be attached to the patient's femur 124 by pressure applied through the body 102 and flanges 104, 106, as explained below.

[0060] In practice, the femur cutting board 100 is attached to the end 122 of a patient's femur 124, as illustrated in FIG. 12. Again, since the bone-contacting surface 112 of the cutting board 100 has a negative contour 114, the board 100 can be attached to the femur 124 in a unique and anticipated position. When attached in this way, flanges 104, 106 surround the distal end 126 of femur 124 and edges 110, 112 of flanges 104, 106 surround the posterior side of femur 124. Additionally, when the table 100 is engaged with the patient's femur 124, a portion of the anterior side of the femur 124 is housed in the negative contour 112 of the body 102, a portion of the distal end 126 is housed in the negative contour 112 of the flanges 104, 106, and a portion of the posterior side of the femur 124 is accommodated in the negative contour (if any) of edges 110, 112. Thus, the anterior, distal, and posterior surfaces of the femur 124 are supported by the femur cutting board 100. The body 102, tabs 140, 106, and edges 110, 112 of the femur cutting board 100 they work together to secure instrument 100 to femur 124. That is, body 102, flanges 140, 106, and edges 110, 112 apply pressure on femur 124 to hold board 100. However, multiple guide pins (not shown in illustration) can be inserted into pin guides 120, 121 and femur 124 to secure cutting board 100 to femur 124. What's more, pin guides 120, 121 can be used to poke holes in the femur 124 that serve as useful references for future actions, such as orienting a cutting board (not shown) or a bevel block (not shown).

[0061] After the board 100 has been secured to the patient's femur (124), the orthopedic surgeon can use the femur cutting board to remove a previously anticipated amount of femur 124. That is, the cut in the bone made with the cutting guide 118 corresponds to the cutting plane determined during the manufacture of the cutting table 100 (see step 24 of algorithm 10 previously described in FIG. 1). It should be noted that since the platform for cutting guides 116 is above body 102, the depth of cutting guide 118 is increased, which provides stability to the cutting edge of the orthopedic bone saw or other cutting devices used. .

Referring now to FIGS. 13-15, the patient-specific custom orthopedic surgery instrument may be a 1300 femur cutting board. The 1300 cutting board is configured to attach to a patient's femur in a similar manner to the 1300 cutting board. previously described cut. Cutting board 1300 includes a body 1302 configured to be attached to the anterior side of a patient's femur and two arms or tabs 1304, 1306 protruding from the body 1302 in a rearward direction. Flanges 1304, 1306 are configured to surround a distal end of the femur, as explained in more detail below. Each flange 1304, 1306 has an edge 1308, 1310 that curves inward or extends upward, respectively, which supports the posterior condyles of the femur. The cutting board 1300 can be made from any suitable material. For example, the cutting board 1300 can be made of plastic or a resin material. Optionally, the cutting board 1300 can be made from a photocurable resin or a laser cured resin. In a particular embodiment, the cutting board 1300 is manufactured with a Vero resin, commercially available from Objet Geometries Ltd. of Rehovot (Israel), using a rapid prototyping manufacturing process. However, the cutting board 1300 can be made from other materials. For example, in another particular embodiment, the cutting board 1300 is manufactured from a thermoplastic polyimide resin, such as Ultem resin, which can be purchased from Saudi Basic Industries Corporation Innovative Plastics of Riyadh (Saudi Arabia).

The body 1302 has a surface in contact with or facing the bone 1312 and an outer surface 1314 opposed to the surface facing the bone 1312. The outer surface 1314 has a depression or hollow area 1316, indicating the surgeon where to apply pressure to body 1302 when coupling cutting board 1300 to the patient's femur. Additionally, a number of guide pin holes or passages 1318 may be found that traverse the body 1302 and have a diameter the size of which is adequate to accommodate the corresponding guide pins for the purpose of securing the board 1300 to the femur of the patient. Optionally, one or more of the guide pin holes 1318 may be oblique or angled relative to the remaining guide pin holes 1318, in order to further secure the board 1300 to the patient's bone.

[0064] Body 1302 has a modular cutting guide 1320. That is, body 1302 has a receiving slot for cutting guides 1322 in which cutting guide 1320 is housed. A latch 1324 or other closure apparatus ensures the cutting guide 1320 to the receiving slot for cutting guides 1322. Thus, one of several cutting guides 1320 having a cutting guide slot 1326 disposed at various alternate positions can be attached to body 1302 to allow the surgeon to selectively determine the amount of bone from the patient to be removed during the intervention to cut the bone. For example, a 1320 cutter guide that has a slot for

ES 2 556 909 T3 cutting guides 1326 with a deviation of +2 millimeters - relative to a neutral reference cutting guide 1320 - can be used if the surgeon wishes to remove a greater amount of bone from the patient. Cutting guide 1320 can be made from the same material as body 1302 or from a different material. In a particular embodiment, the cutting guide 1320 is made of a metallic material such as, for example, stainless steel.

The bone facing surface 1312 of body 1302 has a negative contour 1328 configured to accommodate a portion of the anterior side of a patient's femur which has a corresponding contour. As previously explained, the personalized, patient-specific negative contour 1328 of the bone-contacting surface 1312 allows cutting board 1300 to be positioned on the patient's femur in a single, predetermined location and orientation.

[0066] As previously explained, the arms or flanges 1304, 1306 extend towards the rear of the body 1300 creating a U-shaped opening in the middle. The flanges 1304 can have the same distance or a different distance. . For example, as shown in FIG. 14, the flange 1304 exiting the body 1300 has a length 1330, and the flange 1306 exiting the body 1330 has a length 1332, which is greater than the length 1330. Each flange 1304, 1306 has its respective guide pin passages or holes 1138, 1340. Guide pin holes 1138, 1340 are sized to accommodate the corresponding guide pins for the purpose of securing table 1300 to the patient's femur.

[0067] The flanges 1304, 1306 have a surface in contact with or facing the bone 1340, 1342, respectively, and an outer surface 1344, 1346, respectively, opposite the surface facing the bone 1340, 1342. The The bone facing surface 1340 of flange 1304 has a negative contour 1348 configured to receive a portion of the distal side of the patient's femur, which has a corresponding contour. Similarly, the bone facing surface 1340 of flange 1306 has a negative contour 1350 configured to accommodate a portion of the distal side of the patient's femur, which has a corresponding contour.

The edges 1308, 1310 of the flanges 1304, 1306 also have a surface in contact with or facing the bone 1352, 1354, respectively, and an outer surface, 1356, 1358, respectively, opposite the surface located facing bone 1352, 1354. The bone facing surface 1352 of edge 1308 has a negative contour 1360 configured to accommodate a portion of the posterior side of the patient's femur, which has a corresponding contour. Similarly, the bone facing surface 1354 of edge 1310 has a negative contour 1362 configured to accommodate a portion of the distal side of the patient's femur, which has a corresponding contour. Each edge 1308, 1310 has a lateral groove 1364 that forms a raised or serrated contour groove and is configured to provide a margin or clearance to the cutting edge of the bone saw that is used to remove a portion of bone from the patient. Thus, during orthopedic surgery, slot 1364 can accommodate a distal end of the cutting edge of the bone saw.

[0069] Optionally, the negative contours 1328, 1344, 1346, 1356, 1358 of the bone-contacting surfaces 1312, 1340, 1342, 1352, 1354 of the cutting table 1300 may or may not correspond to the corresponding contour surfaces of the patient's bone. Therefore, as previously explained, negative contours 1328, 1344, 1346, 1356, 1358 can be scaled or assigned another size (for example, enlarged) to compensate for the patient's lack of cartilage, for example.

[0070] In practice, the femur cutting board 1300 engages the distal end of the patient's femur. Again, since the bone-contacting surfaces 1312, 1340, 1342, 1352, 1354 of the cutting board 1300 have negative contours 1328, 1344, 1346, 1356, 1358, the cutting board 1300 can be attached to the femur of the patient in a unique position and planned in advance. When this happens, flanges 1304, 1306 surround the distal end of the patient's bone and edges 1308, 1310 of flanges 1304, 1306 surround the posterior side of the patient's femur. Additionally, when the table 1300 is attached to the patient's femur, a portion of the anterior side of the femur is housed in the negative contour 1328 of the body 1302, a portion of the distal side of the femur lodges in the negative contours 1344, 1346 of the flanges 1304, 1306, and a portion of the posterior side of the femur is accommodated in the negative contours 1356, 1358 of the edges 1308, 1310. Thus, the anterior, distal, and posterior surfaces of the patient's femur are supported by the Femur Cutting Board 1300.

Referring now to FIGS. 16-18, the patient-specific custom orthopedic surgery instrument may be a femur cutting board 1400. The cutting board 1400 is configured to engage a patient's femur in a similar manner to the cutting board 100 described. previously. The cutting board 1400 has a body 1402 configured to be attached to the anterior side of a patient's femur and two arms or tabs 1404, 1406, protruding from the body 1402 in a rearward direction. Flanges 1404, 1406 are configured to surround a distal end of the femur, as explained in more detail below. Each flange 1404, 1406 has an edge 1408, 1410 that curves inward or extends upward, respectively, which supports the posterior condyles of the femur. Similar to cutting board 1300, cutting board 1400 can be made from any suitable material. For example, the cutting board 1400 can be made of plastic or a resin material. In a particular embodiment, the cutting board 1400 is manufactured with a Vero resin, using a manufacturing process for rapid prototypes. However, the cutting board 1400 can be made from other materials. For example, in another particular embodiment, the cutting board 1400 is manufactured from a thermoplastic polyimide resin, such as Ultem resin, which is commercially available from Saudi Basic Industries Corporation Innovative Plastics of Riyadh (Saudi Arabia).

[0072] Body 1402 has a bone-contacting or facing surface 1412 and an outer surface 1414 opposite bone-contacting surface 1412. Outer surface 1414 has a number of guide holes or passages 1416. A bearing for guide pin 1418 is housed in each guide hole 1416. Guide pin bearings 1418 have an inner passage 1420 that has been sized to accommodate its corresponding guide pin for the purpose of securing table 1400 to the patient's femur. As i know

ES 2 556 909 T3 shown in FIG. 18, guide passage 1416 runs from outer surface 1414 to bone facing surface 1412 and is reamed at bone facing surface 1412. Thus, passage 1416 has an opening 1422 in bone facing surface 1412 having a diameter greater than the diameter of an opening 1424 in the outer surface.

[0073] Cut guide 1400 includes cut guide 1430 secured to body 1402. In a particular embodiment, cut guide 1430 is overmolded to body 1402. Cut guide 1430 has a slot for cut guides 1432. cutting guide 1430 can be made from the same material as body 1402 or from a different material. In a particular embodiment, the cutting guide 1430 is made of a metallic material such as, for example, stainless steel. The body 1402 also has a window or opening 1434. The opening 1434 allows the surgeon to visualize the positioning of the board 1400 on the patient's femur, so that parts of the femur can be seen through the opening 1434. Additionally, the opening 1434 You can reduce the number of air pockets or other imperfections that have formed during the manufacturing process of the 1400 table. In an enlightening embodiment, the opening 1434 runs from the cutting guide 1400 to a point higher than the highest point 1436 of the bearings for the guide pins 1418. However, the cutting board 1400 may have windows or openings in body 1402 having other sizes and shapes.

The bone-facing surface 1412 of body 1402 has a negative contour 1438 configured to accommodate a portion of the anterior side of a patient's femur, which has a corresponding contour. As previously explained, the personalized, patient-specific negative contour 1438 of the bone-contacting surface 1412 allows cutting board 1400 to be positioned on the patient's femur in a single, predetermined location and orientation.

[0075] Flanges 1404, 1406 have a bone-facing or facing surface 1440, 1442, respectively, and an outer surface 1444, 1446, respectively, opposite bone-facing surface 1440, 1442. The bone facing surface 1440 of flange 1404 has a negative contour 1448 configured to accommodate a portion of the distal side of the patient's femur, which has a corresponding contour. Similarly, the bone facing surface 1142 of flange 1406 has a negative contour 1450 configured to accommodate a portion of the distal side of the patient's femur, which has a corresponding contour.

[0076] As previously explained, the arms or flanges 1404, 1406 extend towards the rear of the body 1400 creating in the middle a U-shaped opening 1405. The flanges 1404 can have the same distance or a distance different. For example, as shown in FIG. 17, the flange 1404 exiting the body 1400 has a length 1452, and the flange 1406 exiting the body 1400 has a length 1454, which is greater than the length 1452. Each flange 1404, 1406 has its respective guide passage or hole 1460. A bearing for guide pin 1462 is housed in each guide hole 1460. Bearings for guide pins 1462 have an inner passage 1464 that is sized to fit house its corresponding guide pin in order to secure table 1400 to the patient's femur. Similar to guide passages 1416, guide passages 1460 may be counterbore in the bone facing surfaces 1440, 1442 of flanges 1404, 1406.

[0077] The edges 1408, 1410 of the flanges 1404, 1406 also have a bone-facing or facing surface 1472, 1474, respectively, and an outer surface, 1476, 1478, respectively, opposite the bone-facing surface. facing bone 1472, 1474. The bone facing surface 1472 of edge 1408 has a negative contour 1480 configured to accommodate a portion of the posterior side of the patient's femur, which has a corresponding contour. Similarly, the bone facing surface 1474 of edge 1410 has a negative contour 1482 configured to accommodate a portion of the distal side of the patient's femur, which has a corresponding contour. Each edge 1408, 1410 has a lateral groove 1484 that forms a raised or serrated contour groove and is configured to provide a margin or clearance for the edge of the bone saw that is used to remove a portion of bone from the patient. . Thus, during orthopedic surgery, slot 1484 can accommodate a distal end of the cutting edge of the bone saw.

[0078] Optionally, the negative contours 1438, 1448, 1450, 1480, 1482 of the bone-contacting surfaces 1412, 1440, 1442, 1452, 1472 of the cutting table 1400 may or may not correspond to the corresponding contour surfaces of the patient's bone. Thus, as previously explained, negative contours 1438, 1448, 1450, 1480, 1482 can be scaled or assigned another size (eg, enlarged) to compensate for the patient's lack of cartilage, for example.

[0079] In practice, the femur cutting board 1400 engages the distal end of the patient's femur. Again, since the bone-contacting surfaces 1412, 1440, 1442, 1472, 1472 of the cutting board 1400 have negative contours 1438, 1448, 1450, 1480, 1482, the cutting board 1400 can be attached to the femur of the patient in a unique position and planned in advance. When this happens, flanges 1404, 1406 surround the distal end of the patient's bone and edges 1408, 1410 of flanges 1404, 1406 surround the posterior side of the patient's femur. Additionally, when the table 1400 is attached to the patient's femur, a portion of the anterior side of the femur is accommodated in the negative contour 1438 of the body 1402, a portion of the distal side of the femur is accommodated in the negative contours 1448, 1450 of the flanges. 1404, 1406, and a portion of the posterior side of the femur is accommodated in negative contours 1480, 1482 of edges 1408, 1410. Thus, the anterior, distal, and posterior surfaces of the patient's femur are supported by the Femur Cutting Board 1400.

Referring now to FIG. 19, optionally, a milling machine 300 is installed in a healthcare facility 5302 to facilitate the fabrication of the patient-specific, customized orthopedic surgery instrument. The health center 5302 can be a health center, such as a hospital or the like, in which the orthopedic surgery will be performed. Alternatively or additionally, health center 5302 may be the orthopedic surgeon or other physician's office.

ES 2 556 909 T3

The milling machine 300 includes a processor 5304, an input peripheral 5306, and a mill or grinder 5310. The processor 5304 can be any type of processor including, for example, a discrete processing circuit (that is, a variety of logic devices), integrated circuits for general use and / or integrated circuits for specific applications (for example, ASICs). Input peripheral 5306 can be any type of input peripheral configured to accept portable media (not shown) such as CD, digital video disc, USB, or others. Thus, input peripheral 5306 can be any type of serial peripheral, parallel peripheral, a port for flash drives, or another data port or peripheral capable of communicating with and storing data on the portable media. The processor 5304 is intercommunicated with the input peripheral 5306 through various links 5308. These links 5308 can be any type of communication links capable of facilitating communication between the processor and 5304 and the input peripheral 5306. For example, the Links 5308 can be various types of cables, fiber optic cables, wireless signals and / or the like.

[0082] The 5300 milling machine also has a 5310 mill that is intercommunicated with the 5304 processor through various 5312 communication links or links. Similar to the 5308 links, the 5312 links can be any type of links capable of facilitating communication between the 5304 processor and the mill. For example, communication links 5312 can be various types of cables, fiber optic cables, wireless signals, and / or the like. The 5310 mill can include any type of mill and related apparatus and circuitry capable of fabricating a custom, patient-specific orthopedic surgical instrument from suitable materials such as plastic or metal.

[0083] In practice, processor 5304 is configured to control mill 5310 and manufacture the patient-specific, customized orthopedic surgery instrument. Processor 5304 can be configured to control mill 5310 based on a software algorithm received through input peripheral 5306. For example, the software algorithm that the processor 5304 executes to control the grinder 5310 can be loaded via CD or USB, connected to the peripheral or input port. In some embodiments, the software algorithm can be purchased from a merchant or vendor. For example, returning to FIG. 1, the patient-specific custom orthopedic surgery instrument model generated in step 526 of algorithm 510 may be a software algorithm that can be used by the 5300 milling machine. The merchant can submit or pass the software algorithm to the orthopedic surgeon to download it to the 5300 milling machine. Thus, the 5300 milling machine is configured to manufacture the customized, patient-specific orthopedic surgery instrument based on the software algorithm instructions. In this way, the manufacturing of the customized and patient-specific orthopedic surgery instrument is carried out locally, while the design of the instrument can be carried out outside of the 5302 health center.

[0084] One way to facilitate remote fabrication of the customized and patient-specific orthopedic surgery instrument is to use a network (such as the Internet). In this case, the surgeon or other healthcare provider requests an instrument including data relevant to a specific patient. The request can include data and information such as medical images showing the patient's bones such as the femur and tibia. A client machine 5314 related to the surgeon or other healthcare provider (eg, located at the health center) may be used to order the instrument from the merchant.

The merchant or vendor may have a design plan system 5316. The design plan system 5316 may receive a request to perform an instrument over the network used by the client machine 5314 located, for example, at the health center 5302, generate a design plan that has been customized based on the information received along with the application and, via the network, provide the health center 5302 with the personalized design plan. The design plan system 5316 may include one or more computing devices and associated software, middleware, and / or firmwares, which work together to carry out design plan customizations.

[0086] Once the design plan has been submitted to healthcare facility 5302, it is transferred to milling machine 5300. The milling machine 5300 then uses the design plan to manufacture the custom orthopedic surgery instrument specific to the patient.