Patient-specific knee alignment guide

ES 2 669 578 T3

DESCRIPTION

Patient specific knee alignment guide and associated method

Introduction

Proper alignment of prosthetic components in knee arthroscopy is an important factor in the longevity and function of the implant. Misalignment can cause increased implant wear, patient discomfort, and functional limitation. Document WO 2011/063231 A1 describes a system comprising a guide, the guide has a guide opening that when the guide is placed on the bone is directed to a planned location with respect to the soft tissue, an instrument configured to be guided by the guide opening and forms a first hole at the planned location in the bone and a syringe having a member configured to be positioned in the first hole formed.

Although various methods and devices are known to address the above problems, patient-specific alignment methods and alignment guides are still desirable.

Resume

The present invention is defined in claim 1 and can be used in a method of preparing a joint for a prosthesis in a patient. In one aspect, the method includes obtaining scanned data associated with the patient's joint, preparing a three-dimensional image of the joint based on the scanned data, preparing an interactive initial surgical plan based on the scanned data, sending the surgical plan to a surgeon, I received a finalized surgical plan from the surgeon, and prepared an image of a patient-specific alignment guide.

In another aspect, the method includes securing a patient-specific alignment guide to an articular surface of the patient, attaching a guide element to the joint surface through the alignment guide, removing the alignment guide without removing the guide element. and resecting the articular surface using the guide element.

The present teachings also provide a method of preparing a knee joint for a prosthesis in a patient. The method includes locking a patient-specific femoral alignment guide onto a surface of the patient's femoral joint by inserting at least a first guide element through the femoral alignment guide on the anterior or anterior medial side of the joint surface. femoral artery, and drill resection location openings on the distal side of the femoral joint surface. The method further includes removing the femoral alignment guide without removing the first guide member, supporting a femoral resection device on the first guide member, and resecting the surface of the femoral joint.

The present invention further provides an orthopedic device for preparing a knee joint for a prosthesis in a patient. The orthopedic device includes a femoral alignment guide that has a patient-specific three-dimensional curved inner surface. The curved inner surface is preoperatively configured from medical imaging scans of the patient's knee joint to be nested and mating and coincident in only one position with a corresponding three-dimensional femoral surface of a patient's articulating surface. The femoral alignment guide has a first guide opening corresponding to a distal part of the femoral surface and a second guide opening corresponding to an anterior part of the femoral surface.

A method of preparing a knee joint for a prosthesis in a patient is disclosed. The method includes mating a patient-specific 3-dimensional curved inner surface of a femoral alignment guide onto a corresponding patient 3-dimensional femoral articulation surface, the patient-specific 3-dimensional curved inner surface preoperatively configured from medical scans of the joint of the patient's knee, by drilling a first hole in an anterior part of the femoral joint surface through a corresponding first guide opening of the femoral alignment guide and drilling a second hole in an anterior part of the femoral joint surface through a second corresponding guide opening of the femoral alignment guide. In the method, the second guide opening is positioned asymmetrically relative to the first guide opening in the femoral alignment guide. The method may further include engaging a portion of the inner surface of the femoral alignment guide with the articular cartilage covering the surface of the femoral joint. The method may further include mating a portion of the inner surface of the femoral alignment guide with a portion of bone underlying the articular cartilage of the surface of the femoral joint. The method may further include inserting the first and second guide pins through the corresponding first and second guide openings and the first and second holes. The method may further include removing the femoral alignment guide without removing the first and second guide pins. The method may further include sliding the femoral alignment guide through corresponding perimeter open portions of the first and second guide openings. The method may further include supporting a shear block on the first and second guide pins. The method may further include guiding a patient-specific femoral resection through the cutting block, the specific resection determined

ES 2 669 578 T3 of the patient by preoperative configuration of the first and second guide openings in the femoral alignment guide to correspond to the specific resection of the patient.

According to various embodiments, a method of preparing a knee joint for a prosthesis in a patient may include mating a patient-specific three-dimensional curved inner surface of a femoral alignment guide onto a corresponding three-dimensional femoral joint surface of a patient, the patient-specific three-dimensional curved inner surface preoperatively configured from medical scans of the patient's knee joint, drilling first and second holes in an anterior portion of the femoral joint surface through corresponding first and second openings of femoral alignment guide, wherein the first and second guide openings are configured preoperatively to locate a femoral resection of the patient in accordance with the medical scans of the patient and a preoperative surgical plan for the patient, and inserting first and second guide pins through the openings of corresponding first and second guide and the first and second hole. The method may further include removing the femoral alignment guide without removing the first and second guide pins. The method may further include sliding the femoral alignment guide through corresponding perimeter open portions of the first and second guide openings. The method may further include supporting a shear block on the first and second guide pins. The method may further include guiding a patient-specific femoral resection through the cutting block. The method may further include mating a portion of the inner surface of the femoral alignment guide with at least one of the articular cartilage and underlying bone on the surface of the femoral joint.

A method of preparing a knee joint for a prosthesis in a patient may include the engagement of a patient-specific 3-dimensional curved inner surface of a tibial alignment guide onto a corresponding patient's 3-dimensional tibial articulation surface, the specific 3-dimensional curved inner surface set preoperatively from medical scans of the patient's knee joint, and wrapping a portion of the tibial alignment guide around an anterior medial edge of the surface of the tibial joint. The method may further include drilling a first tibial guide hole in an anterior portion of the surface of the tibial joint through a corresponding first anterior opening in the tibial alignment guide. The method may further include drilling a second tibial guide hole in an anterior portion of the tibial joint surface through a corresponding second anterior opening in the tibial alignment guide. The method may further include inserting the first and second guide pins through the corresponding first and second anterior openings and into the corresponding first and second tibial guide holes. The method may further include removing the tibial alignment guide without removing the first and second guide pins by sliding the tibial alignment guide through open portions of the corresponding perimeters of the first and second anterior openings of the guide. tibial alignment.

Other areas of applicability of the present invention will become apparent from the description provided below. It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the invention.

Brief description of the drawings

The present invention will be more fully understood from the detailed description and accompanying drawings, in which:

FIG. 1 is a flow chart of an exemplary method of preparing patient specific alignment guides in accordance with the present teachings;

FIG. 2 is a flow chart of an alignment method according to the present teachings;

FIG. 3 is a view illustrating the mechanical axis in the anatomical image of a patient;

FIG. 4 is a view illustrating the transepicondylar and cylindrical axes in the anatomical image of a patient.

FIG. 5 is a view illustrating the mechanical and anatomical axes in the femoral image of a patient;

FIG. 6 is a flow chart of an exemplary method of using patient specific alignment guides in accordance with the present teachings;

FIG. 7 is an example image of the anatomy of a patient with implants shown, as viewed in interactive software in accordance with the present teachings;

FIG. 8 is a perspective view of an exemplary femoral alignment guide in accordance with the present teachings, shown in conjunction with a corresponding anatomical femur;

ES 2 669 578 T3

FIGS. 9A and 9B are perspective views of the femoral alignment guide of FIG. 8 shown mounted on the femur;

FIGS. 10A and 10B are perspective views of the femoral alignment guide of FIG. 8 shown with spring pins holding the alignment guide to the femur;

FIG. 11A is a perspective view of the femoral alignment guide of FIG. 8 shown with a hole punch guide;

FIG. 11B is a perspective view of the femoral alignment guide of FIG. 11A shown with two guide pins drilled through the drill guide;

FIG. 11C is a perspective view of the femoral alignment guide of FIG. 11B showing removal of the hole punch guide;

FIG. 12A is a perspective view of the femoral alignment guide of FIG. 11C shown after punch guide removed;

FIG. 12B is a perspective view of the femoral alignment guide of FIG. 12A shown after removal of spring pins;

FIG. 13A is a perspective view of FIG. 12B illustrating the guide pins after removal of the femoral alignment guide;

FIG. 13B illustrates a detail of the femoral alignment guide of FIG. 12B;

FIG. 14A is a perspective view of a distal femoral cutting block shown on two pins in a patient's femur, in accordance with the present teachings;

FIG. 14B is a perspective view of a distal femoral cutting block shown on two guide pins in a patient's femur, in accordance with the present teachings;

FIG. 15A is a perspective view of an exemplary 4-in-1 cutting block positioned in the femur with reference to holes corresponding to the spring pins;

FIG. 15B is a perspective view of the cutting block of FIG. 15A shown with a cutting blade;

FIG. 16A is a perspective view of a tibial alignment guide in accordance with the present teachings, shown mounted on the tibia;

FIG. 16B is a perspective view of the tibial alignment guide of FIG. 16A shown with a punch guide;

FIG. 16C is a perspective view of FIG. 16B illustrating the guide pins after removal of the tibial alignment guide;

FIG. 16D is a perspective view of FIG. 16C illustrating a tibial cutting guide mounted on the guide pins;

FIG. 17 is an environmental perspective view of a distal femur with a guide placed thereon and an instrument that forms a hole in the femur;

FIG. 17A is a perspective view of the guide of FIG. 17; Y

FIG. 18 is an environmental view of a distal femur with a guide placed thereon and an instrument position in a gap through the guide.

Description of various aspects

The following description is merely exemplary in nature and is in no way intended to limit the scope of the present teachings, applications, or uses. For example, while the present teachings are illustrated for alignment guides in knee surgery, the present teachings can be used for other guides, templates, fasteners, piercers, scrapers, or other instruments used in various orthopedic procedures.

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The present teachings provide a method of preparing patient specific alignment guides for use in orthopedic surgery for a joint, such as, for example, the knee joint. Conventional, non-patient-specific prosthetic components available in different sizes can be used with the alignment guides, although patient-specific femoral and tibial prosthetic components prepared with computer-assisted imaging methods can also be used. Computer modeling to obtain three-dimensional images of the patient's anatomy, such as the patient's joint, for example, patient-specific prosthetic components, when used, and alignment templates and guides can be provided by various CAD and / or software available from various vendors or developers, such as from Materialize USA, Ann Arbor, Michigan.

With reference to FIG. 1, an MRI scan or a series of CT scans of the entire leg of the joint to be reconstructed, including the hip and ankle, as shown in FIG. 3, it can be performed in a medical facility or doctor's office, in aspect 10. In some cases, the scan can be performed with the patient using a discharge clamp to tension the ligaments. The scanned data obtained can be sent to a manufacturer, in aspect 20. The scan data can be used to construct a three-dimensional image of the joint and provide an initial fit and fit of the implant in a computer file or other computer representation form. The initial fit and alignment of the implant can be obtained using an alignment method, such as the alignment method illustrated in FIG. 2 and described below. Other alignment methods can also be used, such as alignment protocols used by individual surgeons.

The result of the initial fitting is an initial surgical plan that can be printed or provided electronically with the appropriate visualization software. The initial surgical plan can be surgeon-specific, when surgeon-specific alignment protocols are used. The initial surgical plan, in the form of a computer file associated with interactive software, can be sent to the surgeon or other medical professional for review, at 30. The surgeon can incrementally manipulate the position of the images of the implant components 502, 504 in an interactive joint image form 500, as illustrated in FIG. 7. After the surgeon modifies and / or approves the surgical plan, the surgeon can send the final approved plan to the manufacturer, at 40.

Various methods can be used to submit the initial and final surgeon-approved surgical plans. Surgical plans can, for example, be transferred to an electronic storage medium, such as CD, DVD, flash memory, which can then be mailed using regular mail methods. Alternatively, the surgical plan can be emailed electronically or transmitted over the Internet or other web-based service, without the use of a storage medium.

After the surgeon approves the surgical plan, patient-specific alignment guides can be developed for the femur and tibia using a CAD program or other imaging software, such as software provided by Materialize, for example, depending on the surgical plan. , at 50. Toolpath computer instructions for machining patient-specific alignment guides can be generated and stored in a toolpath data file, at 60. The toolpath can be provided as input to a CNC mill or other automated machining system, and the alignment guides can be machined from polymer, ceramic, metal, or other suitable material, and sterilized, at 70. The sterile alignment guides can be shipped to the surgeon or medical facility, in aspect 79 for use during the surgical procedure.

With reference to FIG. 2, an exemplary method of providing initial implant fit and fit is illustrated. The method can be modified or completely replaced according to a surgeon's specific alignment protocol. After the scan data is converted into 3-D images of the patient's anatomy from hip to ankle, the images of the tibial and femoral components can be manipulated to obtain patient-specific alignment using the mechanical femoral and tibial axes. 402, 404, illustrated in FIG. 3, and the transepicondylar and cylindrical axes 406, 408, illustrated in FIG. Four. Images of the anatomy of the knee joint can include images of the joint surfaces of the distal femur and proximal tibia with or without associated soft tissues, such as articular cartilage, on the respective bone surfaces.

In general, the femoral mechanical axis is defined as the line joining the center of the femoral head and the center of the intercondylar notch. The anatomical femoral axis is defined as the line along the center of the femoral tree. The tibial mechanical axis is the line connecting the center of the tibial plateau to the center of the tibial pilon or the center of the distal end of the tibia. The tibial anatomical axis is the line along the center of the tibial tree. The transepicondylar axis is the line that connects the most prominent points of the epicondyles. The cylindrical axis is the line connecting the centers of the condyles when the condyles are brought together by coaxial cylinders. A detailed discussion of the various joint-related axes and the relationship of the transepicondylar axis 406 and the cylindrical axis 408 is provided in Eckhoff et al, Three Dimensional Mechanics, Kinematics, and Morphology of the Knee Viewed in Virtual Reality, J Bone Joint Surg Am. 87: 71-80, 2005, which is incorporated herein by reference.

ES 2 669 578 T3

The relationship of the femoral mechanical shaft 402 to the anatomical shaft 410 for the femur is illustrated in FIG. 5. The femoral and tibial mechanical axes 402, 404 may or may not coincide, as illustrated in FIG. 3. In the following discussion, reference is made to a single mechanical axis 401 spanning the femoral and tibial mechanical axes 402, 404. The alignment procedure illustrated in FIG. 2 makes use of the mechanical, anatomical, transepicondylar, and cylindrical axes to various degrees. The present teachings, however, are not limited to this alignment procedure. Multiple alignment procedures can be provided to accommodate the experience and preference of individual surgeons. For example, the alignment procedure can be based on the anatomical and mechanical axes, or it can be substantially based on the cylindrical axis. In addition, the alignment procedure can be deformity specific, such that it is tailored, for example, to a valgus or varus deformity.

With continued reference to FIG. 2-5 and 7, in image space, tibial component 504 can be aligned 90 ° with mechanical axis 401, in aspect 90. In the frontal plane, femoral component 502 can be aligned 90 ° with respect to axis 401 mechanical, in aspect 100. The femoral component 502 can be positioned for a distal resection of "x" mm, at 110, where "x" can be approximately 9 mm or as another measurement as indicated for a specific patient. The femoral component 502 can be rotated until its distal surfaces are at 90 ° to the distal femoral arch (component flexion / extension), at 120. The femoral component 502 can be moved forward / backward until resection of the medial condyle rear is greater than or equal to "x" mm, in aspect 130.

The size of the femoral component can be determined by observing the anterior resection in relation to the anterior cortex, at 140. By adjusting the femoral size the new size can be positioned in the same place with respect to the distal and posterior cutting planes.

The cylindrical axis 408 of the femur can be located, in aspect 150. The tibia can be flexed 90 ° with respect to the femur about the cylindrical axis 408, in aspect 160. The femoral component 502 can be rotated around the medial condyle until A rectangular flexure space is achieved, in aspect 170. Alternatively, the rotation may be relative to the transepicondylar axis, the anterior / posterior axis, and the posterior condylar axis, or a combination of all four axes. The femoral component 502 can be centered or lateralized in the femur, in aspect 180. The location of several distal holes can also be determined to locate the femoral resection block.

With reference to Figs. 6 and 8-15B, an exemplary alignment guide 600 and method of use in connection with the patient's femur 80 are illustrated. Reference numbers 200-250 refer to aspects of the method of FIG. 6 and are described in connection with the instruments shown in Figs. 8-15B for femur 80.

The alignment guide 600 includes an internal guide surface 640 designed to closely fit, engage, and bond the surface 82 of the patient's femoral joint in three-dimensional space so that the alignment guide 600 and the surface of the femoral joint are in alignment. a nesting relationship with each other. Accordingly, the alignment guide 600 can be adjusted, engaged and adjusted or "snapped" on the distal surface of the femur 80 at a single determined position in the final surgical plane, at 200. The alignment guide 600 can have a variable thickness. In general, the alignment guide 600 can be made as thin as possible while maintaining structural rigidity. For example, certain surrounding areas and various adjacent fixture or guide openings 602, 606 may be thickened to provide structural support to guide a drill or to hold a drill guide or to support other tools or devices. Examples of thickened areas 642 are indicated with dotted lines in FIGS. 9A and 9B. Other areas can be cut to view the underlying bone or cartilage of surface 82 of the femoral joint. Display areas 644 are indicated with dotted lines in FIGS. 9A and 9B.

With reference to Figs. 10A and 10B, the alignment guide 600 may be secured to the surface 82 of the femoral joint with fixation elements or fasteners 624, such as, for example, spring pins or other fixation fasteners that are received through openings 602 distals of the alignment guide 600. The locating holes 602a corresponding to the apertures 602 of the alignment guide 600 can be drilled in the distal femur 80 to locate a femoral resection block or other cutting device 620, such as a 4-in-1 cutting block, at 220. The alignment guide 600 may also include guide openings 606. Guide openings 606 are shown medially anterior to femur 80, but can also be made anterior to femur 80 or in other locations and orientations. The guide openings 606 may be countersunk and have a partially open portion 608 on their perimeter to slide the alignment guide from pins or other fasteners without removing said fasteners, as shown in FIG. 13A and discussed below.

With reference to FIGS. 11A and 11B, a punch guide 700 can be positioned in alignment with guide openings 606. The drill guide 700 may include a body 702 having guide recesses 704 corresponding to guide openings 606. Guide holes 704 may have portions 706 that extend beyond body 702 and into guide openings 606 to facilitate alignment. Drill Guide 700

ES 2 669 578 T3 may also include a handle 710 that extends laterally from the body 702 and is removed from the drilling path.

With reference to FIG. 11C, the guide elements 604, such as pins or other fasteners, for example, may be drilled through the guide holes 704 of the drill guide 700 on the anterior or anterior medial side of the femur 80, in aspect 210 of the method of FIG. 6. Guide elements 604 may be parallel or at other angles relative to each other. Guide elements 604 may define a plane that is parallel to a distal resection plane for the femur.

With reference to FIG. 12A, the punch guide 700 can be removed. With reference to FIGS. 12B-13B, the fasteners 624 can be removed, and the alignment guide 600 can be removed from the femur 80 by sliding the alignment guide 600 out of the guide elements 604 through the open portions 608 of the guide openings 606 without removing the pins. guide elements 604 in the anterior / medial corner of the knee, in aspect 230 of FIG. 6.

The guide elements 604 can be used to prepare the attachment surfaces for the prosthesis by mounting guides / cutting blocks to resect the joint surface. Alternatively, a robotic arm or other automated, guided, or computer controlled device that can guide resections based on the preoperative surgical plan can be mounted to the guide members 604 and assist the surgeon in preparing the joint surface for the prosthesis.

With reference to FIGS. 14A and 14B, examples of distal cutting blocks 610a, 610b that can be mounted on guide element 604 to perform distal resection, in aspect 640 of FIG. 6, are illustrated. A third fixation element 605 oriented obliquely relative to guide elements 604 can also be used. The distal cutting blocks 610a, 610b may have an internal surface 612a, 612b that generally follows the shape of the femur 80 to a lesser or greater degree. The distal cutting blocks 610a, 610b can be disposable or reusable.

With reference to Figs. 15A and 15B, after distal resections are performed with block 610a or 610b, in distal cut the femoral resection block 620 can be mounted with pins or other support elements 622 in holes 602a corresponding to fasteners 624. Resections Femoral resections can be performed using, for example, a cutting blade 630 through slots 632 of the femoral resection block 620, in aspect 250 of FIG. 6.

With reference to Figs. 6 and 16A-D, an example alignment guide 600 is illustrated in connection with the tibia 81 of the patient. Reference numbers 260-300 refer to aspects of the method of FIG. 6 and are described in connection with the instruments shown in FIGS. 16A-16D for the tibia.

Alignment guide 600 may be shaped, nested in three-dimensional space, and fit or "snapped" by design over tibia 81 in a unique position, in aspect 260 of FIG. 6. Alignment guide 600 may wrap around the anterior medial edge of tibia 81, as shown in FIG. 16A. Punch guide 700 can be aligned with countersink guide openings 606 of alignment guide 600, as shown in FIG. 16B. Two or more guide elements 604 can be placed on the anterior medial side of the tibia, in aspect 270 of FIG. 6. An additional fastener may also be used for additional hold for the alignment guide 600. Punch guide 700 and alignment guide 600 can be removed, leaving attached guide elements 604 behind, in aspect 280 of FIG. 6, and as shown in FIG. 16C. A disposable or reusable tibial cutting block 750 can slide over guide elements 604, in aspect 290 of FIG. 6, and as shown in FIG. 16D. Tibial cutting block 750 may include a series of holes 752, which allow cutting block 750 to be translated proximally or distally to adjust the level of distal resection. Tibial resection can be done, at 300.

The present teachings provide patient specific alignment guides that can be used for alignment in orthopedic surgery. Each alignment guide includes an internal surface that nests and fits in three-dimensional space with a corresponding articulation surface of a specific patient. Alignment guides can be used to locate guide elements on the joint surface. After the alignment guides are removed, cut guides or other cutting devices, including automated or robotic devices, can be mounted on the guide elements to make various resection cuts. Because the alignment guides are not used for cutting, the alignment guides do not require substantial thickness to extend anteriorly and consequently have a lower profile and less weight. In addition, because the alignment guides are removed prior to cutting, the present teachings provide an enhanced ability to visualize the cuts and the cutting process.

Subchondral access

In accordance with various embodiments, guide 600 or any appropriate guide member, including guide 600 'illustrated in FIG. 17, may be positioned relative to a bone, such as femur 80, to perform a bone-related procedure. For example, as illustrated in Figure 17, the guide 600 'can be positioned with

ES 2 669 578 T3 in relation to the femur 80 to guide a piercing member, such as a drill or pin 820, to gain access to an interior portion of the femur 80 that is below a surface of the femur. Once a part of the femur is accessed, such as beneath the surface of a femur, a procedure can be performed on the femur for various purposes. For example, the procedure may include tumor resection, bone filling, and / or bone replacement.

According to various procedures, a portion of bone that is below a condyle, also referred to as a subchondral, can be repaired or replaced with a bone void filling material, as in a generally disclosed procedure with Subchondroplasty® instruments and / or access devices. which are provided by Knee Creations LLC, having a place of business in Westchester, Pennsylvania, USA. and / or Subchondroplasty Orthopedics LLC which has a place of business in Westchester, Pennsylvania, USA Subchondroplasty® instruments are known to help gain access to an area of ​​a bone that is below a condyle to perform a procedure on the inside the bone to help support the condyle region, including a condylar cartilage. For example, a subcondular bone can be reinforced or reinforced with a material selected to strengthen the bone and to reinforce and strengthen the support of the condylar cartilage. Appropriate materials may be bone substitute biomimetic materials that can be used to strengthen and / or cause subcondular bone replacement.

Regions that may need strengthening include bone marrow injuries that form and can weaken the support of the condylar cartilage. Consequently, appropriate bone substitute materials can be placed in or around bone marrow lesions to cause bone regeneration and strengthening. Suitable bone substitute materials may include Accufill® bone void filler including injectable calcium phosphate, provided by Knee Creations, LLC which is headquartered in New York, New York, USA. According to various embodiments, Bone void fillers, including calcium phosphate, can be placed in a bone defect to cause regrowth and / or remineralization of a selected bone region.

It is also understood that guide 600 can be used to place an instrument, such as guide elements 604, through one or more guide openings 606 to position the instrument at an appropriate and selected location within the bone. For example, as discussed above, guide 600 can be designed to include internal guide surface 640 that closely fits or conforms to a femoral articulation surface 82. The internal guide surface 640 is generally or specifically a three-dimensional curved internal surface that is preoperatively configured from scans of medical images of the patient, such as a patient's knee joint, to fit and mate in a nested fashion and match only one position with a corresponding three-dimensional femoral surface of the patient. The guide openings 606, therefore, are located in a selected, known, and specific location with respect to the femur 80. The design of the internal guide surface 640 and the placement of the guide opening 606 can help guide and secure guiding any appropriate instrument relative to an interior portion of the bone, including the femur 80. Apertures 606 'may define a patient-specific axis, as described herein, to guide an instrument to form a patient-specific hole or gap and to a specific patient location. Therefore, any appropriate procedure can be performed inside the bone. Appropriate procedures may further include removal of a tumor within the bone, removal of necrotic tissue within the bone, placement of a bone growth implant, placement of a support device within the bone, or other appropriate procedure.

It is understood that guide 600, or any appropriate guide, may be designed to engage a surface of any suitable bone part including a distal femoral bone part surface, a distal anterior femoral bone surface, a vertebral bone surface, a proximal tibial bone surface, or any other appropriate bone surface. In addition, a procedure may be performed with guide 600, in accordance with various embodiments to aid bone fixation, implant a transverse implant through a fracture, tumor removal, bone surface support device or implant, or other proper procedure.

Referring to FIG. 1, the scan data can be generated or obtained in aspect 10. The scan data can include various image data of a patient, including MRI scan data and CT scan data. The scan data can be used to generate an initial surgical plan in aspect 30 that is finalized in aspect 40 to design patient-specific guides in aspect 50. Patient specific guides are manufactured, including machining, in aspect 70 and then sent to a surgeon in aspect 79. The plan finalized by the surgeon in aspect 40 can be based on various diagnoses of a patient. For example, a diagnosis of bone loss, tumor, fracture, and the like can be made based on the patient's scan data. The completed plan may include the placement and / or orientation of a guide opening 606 'in guide 600' so that instruments are guided to selected and known regions of the patient. It will be understood that, although the following discussion refers generally to a subchondrol weakening or injury in relation to a distal femur in a knee joint, any diagnosis can be made and that guide 600 'can be designed, in accordance with the illustrated method. in FIG. 1, to allow the positioning of an instrument in relation to the diagnosed region.

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Turning the reference to FIGS. 17 and 17A, femur 80 is schematically illustrated. The femur 80 can be illustrated as image data on a display device, such as a computer display device. FIG. 17 illustrating femur 80 may represent a natural femur and / or image data or a conversion of image data on a three-dimensional screen for viewing by a user and / or operator, including a surgeon. The femur 80 may include condylar cartilage 800 that may extend over at least a portion of the femur 80 that includes a condylar region 802 that may define at least a portion of the surface 82 of the femoral joint. Other parts of the femur 80 may not include cartilage, such as the medial and / or anterior regions of the femur 80. As illustrated and discussed above, the surface 82 of the femoral joint may form at least a portion of the knee joint where the femur may articulate with a proximal portion of the tibia 81. Near the condyle 82 and generally below the cartilage 800 condylar, a bone lesion and / or weakened bone region 806 can be seen (ie, seen in the patient scan data) and / or diagnosed. The weakened bone region 806 can be diagnosed or visualized based on generally known techniques, including viewing the scans, eg, MRI and CT scans, of the patient and / or a conversion or reconstruction of the scanned data by an expert in The technique. It will be understood that weakened bone region 806 may be representative of any appropriate diagnosis, including the diagnosis of a tumor, fracture, bone marrow injury, or other bone defect or area to perform a procedure.

Once the weakened bone region 806 in the femur 800 is diagnosed, the method illustrated in FIG. 1 can be used to design a patient-specific guide in aspect 50, machine and sterilize the patient-specific guide in aspect 70, and send the guide to the surgeon in aspect 79. The patient-specific guide 600 'can including a patient-specific interior surface 640 'to contact a selected portion of a femur surface 80. It is understood that guide 600 'may be designed to contact a medial, lateral, anterior, medial anterior, lateral anterior, or any appropriate portion of bone. Patient-specific guide 600 'and inner surface 640' may be similar to guide 600 and inner surface 640 discussed above in that the guide can contact, nest, and / or attach to a specific part of the anatomy to align the opening. Patient-specific guidance 606 'with respect to a specific region, such as weakened region 806.

As exemplarily illustrated in FIG. 17, an anterior medial positioning of a patient-specific guide 600 'is illustrated. Guide 600 'may include one or more of guide openings 606' that can be formed through guide 600 '. An instrument, including guide member 604, bore 820, or other appropriate member may be positioned through opening 606 'to form a portal or gap 870 in femur 80. The hole 870 may be a blind hole that ends up moving away from the cartilage 800 so that a port or hole does not form within or through the cartilage 800. Thus, the hole 870 will generally extend only through the bone material and the instrument. that forms the gap does not need to contact or engage the cartilage 800.

Drill 820 may be passed through guide 600 ', such as through guide aperture 606', to engage piercing femur 800 to weakened bone region 806. The positioning of guide 600 'and guide opening 606' may be such that drill 820 advances along a patient-specific axis 822 through femur 800 and into weakened bone region 806. Based on the scan data of aspect 10 of FIG. 1 and the plan in aspect 40, a patient-specific mark may also be placed on the drill 820, including a visible demarcation 830, so that the surgeon knows when the drill 820, including a tip 832, has moved an appropriate amount in the femur 80. The appropriate amount may include the tip 832 being positioned in the weakened bone region 806. The surgeon can then stop the advancement of the perforator 820 in the femur 80 and perform a procedure through the gap 870 at a specific depth of the patient.

Once the drill 820 has been positioned so that at least the tip 832 has reached the weakened junction region 806, a procedure can take place with respect to the femur 80 and the weakened bone region 806. According to various embodiments, a material can be delivered to the weakened bone region 806, such as a bone void filler material, other drug, steroid, demineralized bone, or other appropriate material. In accordance with various embodiments, drill 820 can be cannulated such that material can be delivered through drill 820 directly to weakened bone region 806. According to various embodiments, however, the drill 820 can be withdrawn and a syringe 860 can be moved relative to the femur 80.

With reference to FIG. 18, the syringe 860 may be positioned relative to the femur 80 such that at least one needle or cannulated member 862 is positioned through the gap 870 that is formed within the femur 80 by the drill bit 820. The gap 870 remains in the femur 80 after removing the drill bit 820. The hole 870 is generally a blind hole such that it ends under an external surface of the femur 80. Consequently, blind hole 870 does not extend to a surface of cartilage 800 nor does drill 820 penetrate or contact cartilage 800. Thus, cannulated member 862 of syringe 860 will also not penetrate or contact cartilage 800 during a selected procedure. The gap 870 may also originate from a cartilage-free region of the femur 80, or any appropriate bone. A barrel or reservoir 880 can be filled with selected material that can be expelled through the cannulated member 862 by a plunger mechanism or other pump mechanism 882. A selected treatment, such as a bone void filling material, can then be injected into bone region 806 from syringe 860.

ES 2 669 578 T3

It is understood, however, that other instruments can be passed through the gap 870 into the weakened region 806 of bone. Again, weakened bone region 806 can represent any bone or anatomical feature for which a procedure is appropriate. For example, as discussed above, weakened bone region 806 can be associated with a tumor within the bone, such as within the femur 80. Consequently, an extraction instrument may pass through gap 870 into weakened bone region 806 and a biopsy, excision, or other procedure may occur. For example, a biopsy of the material within weakened bone region 806 may be obtained for further diagnosis, such as confirmation of a cancerous or other growth.

Regardless of the patient's diagnosis, including weakened bone region 806, guide 600 'can be designed based on the plan as illustrated in FIG. 1 to include guide aperture 606 'for guiding an instrument relative to a diagnosed region, including bone weakened region 806. Guide opening 606 'may allow to guide an access forming instrument, such as drill 820, and / or a treatment instrument, such as syringe 860 or a biopsy instrument, as discussed above. Guide 600 'can be positioned relative to femur 80 for various and multiple parts of a procedure to gain access to a single region for both accessing and treating the individual region.

The diagnostic region, which includes the weakened bone region 806 illustrated in FIG. 17, can be accessed due to the patient-specific orientation of guide opening 606 'and / or internal surface 640' of guide 600 'that contacts femur 80. Consequently, a procedure that is subchondral can take place. and does not apply, contact or pierce the cartilage 800 of the femur 80. It is similarly understood that guide 600 'may be designed to contact any specific bone portion to engage, treat, or access a portion of bone that is adjacent to or near a portion of cartilage or soft tissue without contacting or perforating the portion. soft tissue or cartilage. Thus, a procedure and / or treatment of the patient can be performed without disturbing the soft tissue, including cartilage, adjacent to or on a bone of a patient.

The preceding discussion discloses and describes merely exemplary provisions of the present teachings. One skilled in the art will readily recognize from such discussion, and from the accompanying drawings, that various changes, modifications, and variations can be made without departing from the scope of the invention, which is defined by the appended claims.