# Patent

## Title
Alignment guides with patient-specific anchoring elements

## Abstract

An orthopedic device for joint arthroplasty includes an alignment guide and a number of patient-specific anchoring elements. The alignment guide can be mounted on a bone of a patient during joint arthroplasty. The patient-specific anchoring elements extend from an inner surface of the alignment guide and have a patient-specific length relative to an outer bone surface of the bone of the patient.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of U.S. Provisional Application No. 61/446,660, filed on Feb. 25, 2011.
This application is a continuation-in-part of U.S. application Ser. No. 12/978,069 filed Dec. 23, 2010, which is a continuation-in-part of U.S. application Ser. No. 12/973,214, filed Dec. 20, 2010, which is a continuation-in-part of U.S. application Ser. No. 12/955,361 filed Nov. 29, 2010, which is a continuation-in-part of U.S. application Ser. Nos. 12/938,905 and 12/938,913, both filed Nov. 3, 2010, each of which is a continuation-in-part of U.S. application Ser. No. 12/893,306, filed Sep. 29, 2010, which is a continuation-in-part of U.S. application Ser. No. 12/888,005, filed Sep. 22, 2010, which is a continuation-in-part of U.S. application Ser. No. 12/714,023, filed Feb. 26, 2010, which is: a continuation-in-part of U.S. application Ser. No. 12/571,969, filed Oct. 1, 2009, which is a continuation-in-part of U.S. application Ser. No. 12/486,992, filed Jun. 18, 2009, and is a continuation-in-part of U.S. application Ser. No. 12/389,901, filed Feb. 20, 2009, which is a continuation-in-part of U.S. application Ser. No. 12/211,407, filed Sep. 16, 2008, which is a continuation-in-part of U.S. application Ser. No. 12/039,849, filed Feb. 29, 2008, which: (1) claims the benefit of U.S. Provisional Application No. 60/953,620, filed on Aug. 2, 2007, U.S. Provisional Application No. 60/947,813, filed on Jul. 3, 2007, U.S. Provisional Application No. 60/911,297, filed on Apr. 12, 2007, and U.S. Provisional Application No. 60/892,349, filed on Mar. 1, 2007; (2) is a continuation-in-part U.S. application Ser. No. 11/756,057, filed on May 31, 2007, which claims the benefit of U.S. Provisional Application No. 60/812,694, filed on Jun. 9, 2006; (3) is a continuation-in-part of U.S. application Ser. No. 11/971,390, filed on Jan. 9, 2008, which is a continuation-in-part of U.S. application Ser. No. 11/363,548, filed on Feb. 27, 2006; and (4) is a continuation-in-part of U.S. application Ser. No. 12/025,414, filed on Feb. 4, 2008, which claims the benefit of U.S. Provisional Application No. 60/953,637, filed on Aug. 2, 2007.
This application is continuation-in-part of U.S. application Ser. No. 12/872,663, filed on Aug. 31, 2010, which claims the benefit of U.S. Provisional Application No. 61/310,752 filed on Mar. 5, 2010.
This application is a continuation-in-part of U.S. application Ser. No. 12/483,807, filed on Jun. 12, 2009, which is a continuation-in-part of U.S. application Ser. No. 12/371,096, filed on Feb. 13, 2009, which is a continuation-in-part of U.S. application Ser. No. 12/103,824, filed on Apr. 16, 2008, which claims the benefit of U.S. Provisional Application No. 60/912,178, filed on Apr. 17, 2007.
This application is also a continuation-in-part of U.S. application Ser. No. 12/103,834, filed on Apr. 16, 2008, which claims the benefit of U.S. Provisional Application No. 60/912,178, filed on Apr. 17, 2007.
The disclosures of the above applications are incorporated herein by reference.


INTRODUCTION
The present teachings provide various alignment guides with patient-specific anchoring elements for joint arthroplasty.
SUMMARY
The present teachings provide an orthopedic device for joint arthroplasty. The orthopedic device includes an alignment guide and a number of patient-specific anchoring elements. The alignment guide can be mounted on a bone of a patient during joint arthroplasty. The patient-specific anchoring elements extend from an inner surface of the alignment guide and have a patient-specific length relative to an outer bone surface of the bone of the patient.
In some embodiments, a patient-specific anchoring element includes including a first portion designed to penetrate through articular cartilage and a second portion designed to penetrate through an outer surface of the bone underlying the articular cartilage for anchoring the alignment guide in the bone. In some embodiments, anchoring element includes a shoulder between the first and second portions. The shoulder is designed to abut on the outer surface of the bone. In some embodiments, the first portion is patient-specific and has a length equal to the thickness of the specific patient's cartilage at the corresponding location of the bone.
The present teachings also provide a method for preparing a bone of a joint during joint arthroplasty. In some embodiments, the method includes mounting an alignment guide on a bone of a joint of a patient along an alignment direction, and anchoring the alignment guide into a cartilage of the bone using a plurality of patient-specific anchoring elements extending from an inner surface of alignment guide. Each anchoring element has a patient-specific length extending between the inner surface and an end point of the corresponding anchoring element.
In some embodiments, the method includes mounting an alignment guide on an outer cartilage surface of an articular cartilage of an underlying bone of the patient. The alignment guide is anchoring on the patient's anatomy using a plurality of patient specific anchoring elements extending from a cartilage-engaging surface of alignment guide. The method further includes penetrating the cartilage with cartilage-engaging portions of the anchoring elements, and penetrating an outer bone surface of the underlying bone with bone-engaging portions of the anchoring elements. The lengths of the cartilage-engaging portions of the anchoring elements can be determined from the cartilage thickness at corresponding locations of the bone of the patient. The cartilage thickness at each anchoring location can be determined from a three-dimensional computer image of the bone and articular cartilage reconstructed from medical scans of the patient during a preoperative plan for the patient.
The alignment guides can be designed for the articular surfaces of a joint, such as, for example, a knee, hip or shoulder joint. In some embodiments a plurality of anchoring elements uniformly or randomly distributed over the anatomy-engaging surface of the alignment guide are used. In some embodiments, a small number of anchoring elements are used, such as, for example, three non-collinear anchoring elements.
Further areas of applicability of the present teachings will become apparent from the description provided hereinafter. 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 present teachings.



BRIEF DESCRIPTION OF THE DRAWINGS
The present teachings will become more fully understood from the detailed description and the accompanying drawings, wherein:
FIG. 1 is a plan view of a patient-specific alignment guide with anchoring elements according to the present teachings;
FIG. 2 is an environmental sectional view of a patient-specific alignment guide with anchoring elements according to the present teachings;
FIG. 3 is an environmental perspective view of a patient-specific femoral alignment guide with anchoring elements according to the present teachings;
FIG. 4 is an environmental perspective view of a patient-specific tibial guide with anchoring elements according to the present teachings;
FIG. 5 is an environmental sectional view of a patient-specific alignment guide with anchoring elements according to the present teachings;
FIG. 5A is a detail of an anchoring element of FIG. 5;
FIG. 6 is an environmental perspective view of a patient-specific femoral alignment guide with anchoring elements according to the present teachings; and
FIG. 7 is an environmental perspective view of a patient-specific tibial guide with anchoring elements according to the present teachings.



DESCRIPTION OF VARIOUS ASPECTS AND EMBODIMENTS
The following description is merely exemplary in nature and is in no way intended to limit the present teachings, applications, or uses.
The present teachings generally provide various patient-specific alignment and resection guides and other associated instruments for use in orthopedic surgery, such as, for example, in joint replacement or revision surgery. The patient-specific guides can be used either with conventional or patient-specific implant components and can be prepared with computer-assisted image methods. Computer modeling for obtaining three-dimensional (3-D) images of the patient's anatomy using MRI or CT scans of the patient's anatomy, modeling of patient-specific prosthesis components and the patient-specific guides and templates can be configured and designed using various commercial CAD programs and/or software, such as, for example, software by Materialise USA, Ann Arbor, Mich.
Patient-specific alignment guides and implants are generally configured to match the anatomy of a specific patient. The patient-specific alignment guides are generally formed using computer modeling based on the patient's 3-D anatomic image and have an engagement surface that is made to conformingly contact and match a three-dimensional image of the patient's bone surface (with or without cartilage or other soft tissue) in only one position, by the computer methods discussed above. The patient-specific alignment guides are designed and prepared preoperatively using anatomic landmarks, such as osteophytes, for example, and can be mounted intra-operatively without any registration or other guidance based on their unique patient-specific surface guided by the patient's anatomic landmarks.
The patient-specific alignment guides can include custom-made guiding formations, such as, for example, guiding bores or cannulated guiding posts or cannulated guiding extensions or receptacles that can be used for supporting or guiding other non-custom instruments, such as drill guides, reamers, cutters, cutting guides and cutting blocks or for inserting pins or other fasteners according to a surgeon-approved pre-operative plan for performing various resections as indicated for an arthroplasty, joint replacement, resurfacing or other procedure for the specific patient.
The patient-specific guides can also include resection or cutting formations, such as cutting slots or cutting edges or planes used for guiding a cutting blade to perform bone resections directly through the patient-specific cutting guide. The patient-specific guides can be used in minimally invasive surgery. Various alignment/resection guides and preoperative planning procedures are disclosed in commonly assigned and co-pending U.S. patent application Ser. No. 11/756,057, filed on May 31, 2007; U.S. patent application Ser. No. 12/211,407, filed Sep. 16, 2008; U.S. patent application Ser. No. 11/971,390, filed on Jan. 9, 2008, U.S. patent application Ser. No. 11/363,548, filed on Feb. 27, 2006; and U.S. patent application Ser. No. 12/025,414, filed Feb. 4, 2008. The disclosures of the above applications are incorporated herein by reference.
As disclosed, for example, in the above-referenced U.S. patent application Ser. No. 11/756,057, filed on May 31, 2007, in the preoperative planning stage for a joint replacement or revision procedure, an MRI scan or a series of CT scans of the relevant anatomy of the patient, such as, for example, the entire leg of the joint to be reconstructed, can be performed at a medical facility or doctor's office. The scan data obtained can be sent to a manufacturer. The scan data can be used to construct a three-dimensional image of the joint and provide an initial implant fitting and alignment in a computer file form or other computer representation. The initial implant fitting and alignment can be obtained using an alignment method, such as alignment protocols used by individual surgeons.
The outcome of the initial fitting is an initial surgical plan that can be printed or provided in electronic form with corresponding viewing software. The initial surgical plan can be surgeon-specific, when using surgeon-specific alignment protocols. The initial surgical plan, in a computer/digital file form associated with interactive software, can be sent to the surgeon, or other medical practitioner, for review. The surgeon can incrementally manipulate the position of images of various implant components in an interactive image of the joint. Additionally, the surgeon can select or modify resection planes, types of implants and orientations of implant insertion. After the surgeon modifies and/or approves the surgical plan, the surgeon can send the final, approved plan to the manufacturer.
After the surgical plan is approved by the surgeon, patient-specific alignment/resection guides can be designed by configuring and using a CAD program or other imaging software, such as the software provided by Materialise, for example, according to the surgical plan. Computer instructions of tool paths for machining the patient-specific alignment guides can be generated and stored in a tool path data file. The tool path 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. The guides can also be manufactured by various other methods, stereolithography, laser deposition, printing, and rapid prototyping methods. The alignment guides are sterilized and shipped to the surgeon or medical facility, for use during the surgical procedure. Various patient-specific knee alignment guides and associated methods are disclosed in the commonly assigned U.S. application Ser. No. 11/756,057, filed on May 31, 2007 (published as 2007/0288030 on Dec. 13, 2007), which is incorporated herein by reference.
A patient-specific alignment guide can be used to drill holes through corresponding bone of the joint surface and to guide alignment pins through the holes. The alignment guide is then removed leaving the alignment pins for supporting and cutting instruments to make various resections in the bone in preparation for receiving a joint implant.
The various patient-specific alignment guides can be made of any biocompatible material, including, polymer, ceramic, metal or combinations thereof. The patient-specific alignment guides can be disposable and can be combined or used with other reusable non patient-specific cutting and guiding components.
Referring to FIGS. 1 and 2, an exemplary alignment guide 100 is generally illustrated according to the present teachings. The alignment guide 100 has a three-dimensional, curved inner surface 102. In some embodiments, the inner surface 102 nestingly matches and is complementary to a corresponding surface of a patient including various anatomic landmarks, such that the alignment guide 100 can be positioned and nested only in one position relative to the anatomy of the specific patient along an alignment orientation A. The patient's anatomy can be, for example, a bone 80 related to a joint of the patient and including a layer of articular cartilage 83 over an outer bone surface 82. The articular cartilage 83 can extend between the outer bone surface 82 and an outer cartilage surface 84. In this embodiment, the inner surface 102 of the patient-specific guide 100 is designed to match and mate with the outer cartilage surface 84. The alignment guide 100 is designed to be light-weight and can include various cut-outs or windows, such as 104. The alignment guide 100 can include a plurality of patient-specific anchoring elements 111 with end points 113. The anchoring elements 111 can be, for example, spikes, or teeth or pins extending from the anatomy-engaging surface 102 and sized and configured to penetrate the cartilage up to the outer bone surface 82. The anchoring elements 111 can be engage the cartilage 83 at several points for providing three-dimensional anchoring stability. Multiple anchoring elements 111, such as, for example, five or more, can be positioned uniformly or randomly relative to the inner surface 102. Alternatively, a few anchoring elements 111, such as, for example about three to five, can be included at selected or pre-determined and relative positions.
In some embodiments, the anchoring elements 111 can be configured to be parallel to an alignment/mounting direction A for mounting and removing the guide 100, as shown in FIG. 2. Using parallel anchoring elements 111 can avoid tearing the cartilage and thereby reducing the anchoring stability of the alignment guide 100. The alignment/mounting direction can be determined during the preoperative plan for the patient. In some embodiments, the three-dimensional shape of the outer bone surface 82 (and, optionally, the outer cartilage surface 84) can be represented in three-dimensional computer models generated from the medical scans of the patient and used to design the variable and patient-specific height (or length) of each anchoring element 111 such that a geometric envelope of the end points 113 traces a surface complementary and mating with the outer bone surface 82. Accordingly, only the outer bone surface 82 needs to be imaged using standard bone imaging methods, such as CT and two-dimensional X-rays, for example. Therefore, for these embodiments, is not necessary to use methods, such as MRI, that can image the cartilage or other soft tissue. In some embodiments, the length of the anchoring elements is patient-specific. In some embodiments, the length of the anchoring elements 111 can be greater that the corresponding thickness of the cartilage 83, such that the inner surface 102 of the alignment guide 100 does not contact the cartilage.
In some embodiments, each anchoring element 111 can have a length extending from the end point 113 to the inner surface 102 and approximating the thickness of the articular cartilage 83 of the particular bone 80 of the patient at each specific location of the anchoring element 111. The thickness of the cartilage 83 can generally vary with the topography of the joint, i.e., the cartilage distribution is non-uniform over a bone surface for a single patient. There may also be additional gender-, age-, weight- and disease-related cartilage variations. The cartilage of a specific patient can also have various defects or other idiosyncratic features. A detailed cartilage topography of a specific patient can be determined during the pre-operative plan from medical scans/images that can depict bone and soft tissue surfaces, such as, for example, MRI images, CT images or other imaging methods capable of showing bone and/or soft tissue.
In some embodiments, a uniform and constant height can be selected for all the anchoring elements, equal, for example, to the mean or the median or maximum or other value based on the thickness variation of the cartilage of a particular joint surface of the patient. When the maximum thickness of the cartilage is used as the height of all the anchoring elements 111, the inner surface 102 of the patient-specific guide 100 may not contact points of the outer cartilage surface 84 where the cartilage 83 is thinner than the maximum, i.e., there may be some areas of non-contact forming gaps between the cartilage 83 and the anatomy-engaging surface 102. Depending on the location of the cartilage 83, the thickness of the cartilage 103 can vary from 0 to 6-7 mm, with higher thickness generally corresponding to the knee patella of healthy young males. In some embodiments, the inner surface 102 of the guide 100 does not engage the cartilage 83 at all.
Referring to FIG. 3, an exemplary femoral alignment guide 200 according to the present teachings is configured for use with the patient's distal femoral bone 80 (an example of the bone 80 of FIG. 2). The femoral alignment guide 200 can have a light-weight body 201 with a three-dimensional inner surface 202. In some embodiments, the inner surface 202 may be a patient-specific engagement surface that is complementary and made to closely conform and mate with a portion of the anterior-distal articulating or outer cartilage surface 84 of the patient's femur 80 based on the pre-operative plan, as described above. The femoral alignment guide 200 can include a window/opening 204 and first and second distal guiding formations 206 defining guiding bores 207 for guiding corresponding distal alignment pins 220. The femoral alignment guide 200 can also include first and second anterior guiding formations 208 defining guiding bores 209 for drilling holes through the distal femur 80 and guiding corresponding anterior alignment pins 222. Additionally, the femoral alignment guide 200 can include a plurality of anchoring elements 211 that are similar to the anchoring elements 111 described above in reference to FIG. 2. The anchoring elements 211 are also designed to penetrate the articular cartilage 83 for preventing small rotational and/or translational displacements of the femoral alignment guide 200 during use. The anchoring elements 211 can be distributed randomly or uniformly to penetrate the entire outer cartilage surface 84 which the patient-specific femoral guide 200 engages. Alternatively, a few discrete anchoring elements 211 can be used instead, including at least three elements. The anchoring elements 211 can be parallel defining an alignment/mounting direction for inserting and removing the femoral alignment guide 200, as discussed above in connection with FIG. 2, and can engage the cartilage at points arranged in a three-dimensional pattern for providing anchoring stability. The length of the anchoring elements 211 can be variable and patient-specific such that a geometric envelope of their end points traces a surface complementary and mating with the outer bone surface 82.
Referring to FIG. 4, a representative tibial alignment/resection guide 300 is illustrated according to the present teachings. The tibial alignment guide 300 can include a body 301 having a proximal portion 303, an anterior portion 305 and a three-dimensional inner surface 302. In some embodiments, the inner surface can be a patient-specific surface that is complementary and made to closely conform and mate with a portion of an anterior surface 76 and a portion of a proximal surface or outer cartilage surface 74 of the patient's tibia 70 in only one position based on the pre-operative plan. The tibial alignment guide 300 can include first and second proximal guiding formations 306 defining guiding bores 307 for corresponding proximal alignment pins or other fasteners 323. The tibial alignment/resection guide 300 can also include first and second anterior guiding formations 308 defining guiding bores 309 for corresponding anterior alignment pins or other fasteners 327. As discussed above in connection with alignment guides in general and the femoral alignment guide 200 in particular, the tibial alignment guide 300 can be used to drill reference holes for the corresponding proximal and anterior alignment pins 323, 327, which can then be re-inserted as needed for each resection and corresponding resection block after the tibial alignment/resection guide 300 is removed. The tibial alignment/resection guide 300 can optionally include a resection guiding slot 310 for guiding a tibial resection according to the pre-operative plan for the patient. Additionally, the tibial alignment guide 300 can include a plurality of anchoring elements 311 that are similar to the anchoring elements 111 described above in reference to FIG. 2. The anchoring elements 311 are designed to penetrate the tibial cartilage 73 for preventing small rotational and/or translational displacements of the tibial alignment guide 300 during use. The anchoring elements 311 can be distributed randomly or uniformly to penetrate the tibial cartilage 73 between the bone surface 72 and the outer cartilage surface 74 of the proximal tibia over the area that the proximal portion 303 of the patient-specific tibial alignment guide 300 engages. Alternatively, a few discrete anchoring elements 311 can be used instead, including at least three elements in a three-dimensional arrangement. Generally, the anchoring elements 311 can be parallel to an alignment/mounting direction (see FIG. 2) and engage the cartilage at points arranged in a three-dimensional pattern for stability. The length of the anchoring elements 311 can be variable and patient-specific such that a geometric envelope of their end points traces a surface complementary and mating with the outer bone surface 72, as discussed above.
Referring to FIGS. 5 and 5A, a detail of an alignment guide 400 with patient-specific anchoring elements 450 is illustrated according to the present teachings. FIG. 6 illustrates a femoral alignment guide 500 similar to the femoral alignment guide 200, but with patient-specific anchoring elements 550 similar to the patient-specific anchoring elements 450 of FIG. 5. Similar elements between alignment guides 200 and 500 are referenced with numerals having the same second and third digits. FIG. 7 illustrates a tibial alignment guide 600 similar to the tibial alignment guide 300, but with patient-specific anchoring elements 650 similar to the patient-specific anchoring elements 450 of FIG. 5. Similar elements between alignment guides 300 and 600 are referenced with numerals having the same second and third digits. The patient-specific anchoring elements 450, 550 and 650 are similar and are described in reference to FIG. 5, which illustrates generically a portion of a patient-specific alignment guide 400. At least three anchoring elements 450 in a three dimensional pattern can be used for providing anchoring stability in three dimensions. In some embodiments, the alignment guides 400, 500 and 600 can also be patient-specific with three-dimensional cartilage engaging surfaces that can nestingly mate to and be mounted on the outer surface of the articular cartilage of the patient in only one position.
The patient-specific anchoring elements 450 can be designed using a three-dimensional computer image of the patient's anatomy including the articular cartilage surface and the underlying bone during a preoperative plan for the patient. The three-dimensional image can be constructed based on medical scans of the patient, such as MRI, CT, ultrasound or other scans equipped or modified to image soft tissue, such as articular cartilage and using commercially available CAD/CAD imaging software.
Referring to FIGS. 5 and 5A, the patient-specific anchoring elements 450 are configured for penetrating the articular cartilage 83 and anchoring into the underlying bone 80 through the outer bone surface 82. Each anchoring element 450 can include a cartilage-anchoring portion 452 and a bone-anchoring portion 454. The cartilage-anchoring portion 452 can be in the form of an elongated element having a first end 458 attached to an anatomy-engaging surface 402 of the alignment guide 400 and an opposite second end 456 in the form of a patient-specific surface 460 designed for abutting and closely mating with the outer bone surface 82. The geometric envelope of the patient-specific surfaces 460 of all the anchoring elements 450 can be designed during the pre-operative plan to be patient-specific relative to the outer bone surface 82, such that the surface 460 to be complementary and closely mate and conform to the outer bone surface 82. Accordingly, the length of each cartilage-anchoring portion 452 from the first end 458 to the second end 456 is patient-specific and can be selected to be equal to the thickness of the patient's cartilage 83 at the corresponding location for each anchoring element 450. The bone-anchoring portion 454 can be in the form of a spike or pin extending from the second end 456 of the cartilage-anchoring portion 452 for penetrating the outer bone surface 82 and lodging into the bone 80.
With continued reference to FIGS. 5 and 5A, the patient-specific surface 460 forms a shoulder or step 463 between the second end 456 of the cartilage-anchoring portion 452 and the bone-anchoring portion 454. The cartilage-anchoring portion 452 penetrates the cartilage 83 and can be seated in a pocket formed in the cartilage 83 when the alignment guide 400 is pressed against the bone 80 until the bone-anchoring portion 454 penetrates the bone 80 and the patient-specific surface 460 nestingly mates and seats on the outer bone surface 82 under the cartilage. The bone anchoring portion 454 can be made of a material of sufficient strength and/.or rigidity to penetrate the bone 80. In some embodiments, the bone anchoring portion 454 and the cartilage-anchoring portion 452 can be made of different materials. In some embodiments, the bone-anchoring portion 454 can be made separately from the cartilage-anchoring portion 452 and have a portion 459 inserted permanently or removably into the cartilage-anchoring portion 452. In other embodiments, the bone anchoring portion 454 and the cartilage-anchoring portion 452 can be made as one integral or monolithic piece. In some embodiments, the anchoring elements can be parallel to an alignment orientation A. In some embodiments, the anchoring elements can be perpendicular to bone surface 82.
With continued reference to FIGS. 5 and 5A, the cartilage-engaging surface 402 can be designed during the pre-operative plan of the patient as a three-dimensional patient-specific surface that complementarily and nestingly mates with the outer cartilage surface 84 in only one position. In some embodiments, conformance to small variations, such as minute defects, in the outer cartilage surface 84 may be relaxed, although the alignment guide 400 can still be mounted on the outer cartilage surface in only one position and is still patient-specific. In this respect, a small gap “g” may be formed between the outer cartilage surface 84 and the anatomy-engaging surface 402 of the alignment guide 400 in certain locations depending on the profile and condition of the cartilage 83. The cartilage-anchoring portion 452 of each anchoring element 450 has a patient specific length and a patient-specific bone-abutting surface 460. The cartilage-anchoring portion 452 can generally have a diameter or major cross-sectional dimension of about 2-5 mm, while the major cross-sectional dimension of the bone-anchoring portion 454 can be about 1-2 mm. The gap g can also be of the order of 1-2 mm.
As discussed above, the patient-specific anchoring elements 111, 211, 311, 450, 550, 650 can be integrated with various patient-specific guides designed to engage a cartilage bearing articulating surface of a joint, such as the distal femur and the proximal tibia for a knee joint. The patient-specific anchoring elements can also be used, for example, with guides designed to engage the articular surfaces of the hip joint or shoulder joint.
The foregoing discussion discloses and describes merely exemplary arrangements of the present teachings. Furthermore, the mixing and matching of features, elements and/or functions between various embodiments is expressly contemplated herein, so that one of ordinary skill in the art would appreciate from this disclosure that features, elements and/or functions of one embodiment may be incorporated into another embodiment as appropriate, unless described otherwise above. Moreover, many modifications may be made to adapt a particular situation or material to the present teachings without departing from the essential scope thereof. One skilled in the art will readily recognize from such discussion, and from the accompanying drawings and claims, that various changes, modifications and variations can be made therein without departing from the spirit and scope of the present teachings as defined in the following claims.

## Claims

1. An orthopedic device for joint arthroplasty comprising:
an alignment guide mountable on a bone of a patient during joint arthroplasty; and
a plurality of patient-specific anchoring elements extending from an inner surface of the alignment guide and having a patient-specific length relative to an outer bone surface of the bone of the patient, the patient-specific length is a custom length based on a multi-dimensional image of the patient's bone surface and soft tissue covering the bone surface;
wherein the inner surface is a three-dimensional patient-specific surface including a customized shape based on a multi-dimensional image of an outer cartilage surface of the bone of the patient and configured to nestingly mate to and be mounted on the outer cartilage surface of the bone of the patient in only one position.

2. The orthopedic device of claim 1, wherein each patient-specific anchoring element includes a corresponding end point, and the plurality of the end points define a geometric envelope surface that traces a surface complementary and mating with the outer bone surface.

3. The orthopedic device of claim 1, wherein the patient-specific anchoring elements are parallel to an alignment direction.

4. The orthopedic device of claim 1, wherein the soft tissue includes cartilage and the anchoring elements are configured to penetrate through an outer cartilage surface of the bone and penetrate through the outer bone surface of the bone for anchoring the alignment guide on the bone of the patient.

5. The orthopedic device of claim 4, wherein each anchoring element includes a patient-specific cartilage-anchoring portion and a bone-anchoring portion, the cartilage-anchoring portion having first and second ends, the first end extending from the inner surface of the alignment guide, the bone-anchoring portion extending from a portion of the second end of the cartilage-anchoring portion.

6. The orthopedic device of claim 5, wherein a length extending between the first and second ends of the cartilage-anchoring portion is patient-specific and customized for the patient according to a multi-dimensional image of the patient's cartilage covering the bone surface to equal a thickness of the cartilage at the corresponding location on the patient's bone.

7. The orthopedic device of claim 5, wherein the second end of the cartilage-anchoring portion has a patient-specific surface designed to contact and mate with the outer surface of the bone at the corresponding location on the bone.

8. The orthopedic device of claim 5, wherein each anchoring element includes a shoulder between the bone-anchoring portion and the cartilage-anchoring portion, the shoulder configured to abut the outer surface of the bone.

9. The orthopedic device of claim 5, wherein the cartilage-anchoring portion and the bone-anchoring portion are made of different materials.

10. The orthopedic device of claim 5, wherein the bone-anchoring portion includes an end point for penetrating bone.

11. The orthopedic device of claim 1, wherein the alignment guide is a femoral guide configured to be mounted on a distal femoral bone.

12. The orthopedic device of claim 1, wherein the alignment guide is a tibial guide configured to be mounted on a proximal tibial bone.

13. The orthopedic device of claim 1, wherein the patient-specific anchoring elements are randomly distributed over the alignment guide.

14. The orthopedic device of claim 1, wherein the patient-specific anchoring elements are uniformly distributed over the alignment guide.

15. The orthopedic device of claim 1, wherein the plurality of patient-specific anchoring elements includes at least three anchoring elements.

16. The orthopedic device of claim 1, wherein the plurality of patient-specific anchoring elements includes five or more anchoring elements.

17. The orthopedic device of claim 1, wherein the alignment guide includes guiding bores for guiding alignment pins.

18. The orthopedic device of claim 1, wherein the alignment guide is a tibial alignment guide including a first portion engageable to a portion of a proximal surface of a tibial bone of a patient and a second portion engageable to a portion of an anterior surface of the tibial bone.

19. The orthopedic device of claim 18, wherein the anchoring elements extend only from the first portion of the alignment guide for anchoring through cartilage of the proximal surface of the tibial bone.

20. The orthopedic device of claim 1, wherein each one of the patient-specific anchoring elements include a first portion and a second portion extending from the first portion, the first portion configured to extend only to the outer bone surface and the second portion configured to extend into the outer bone surface.

21. An orthopedic device for joint arthroplasty comprising:
an alignment guide including an inner surface configured to be mounted on an outer articular cartilage surface of an underlying bone of the patient; and
a first anchoring element extending from the inner surface, the first anchoring element including a first portion designed to penetrate through articular cartilage and a second portion designed to penetrate through an outer surface of the bone underlying the articular cartilage for anchoring the alignment guide on the bone, the first anchoring element including a shoulder between the first and second portions, the shoulder designed to abut on the outer surface of the bone;
wherein the inner surface is a three-dimensional patient-specific surface including a customized shape based on a multi-dimensional image of an outer cartilage surface of the bone of the patient and configured to nestingly mate to and be mounted on the outer cartilage surface of the bone of the patient in only one position.

22. The orthopedic device of claim 21, wherein the first portion is patient-specific and has a length equal to a thickness of the specific patient's cartilage at the corresponding location of the bone, the length is a custom patient-specific length corresponding to a multi-dimensional image of the patient's cartilage.

23. The orthopedic device of claim 22, further comprising a second and third anchoring element, each anchoring element including a shoulder between respective first and second portions, the shoulders designed during a pre-operative plan of the patient to form a geometric envelope surface complementary to the outer surface of the bone for abutting on the outer surface of the bone.

24. An orthopedic device for joint arthroplasty of a patient comprising:
an alignment guide including an inner anatomy-engaging surface configured to be mounted on an outer articular cartilage surface of an underlying bone of the patient;
a plurality of patient-specific anchoring elements extending from the inner anatomy-engaging surface, each one of the plurality of patient-specific anchoring elements including:
a cartilage anchoring portion including a first end coupled to the inner anatomy-engaging surface, a second end opposite to the first end, and a patient-specific length that is about equal to a thickness of the patient's articular cartilage at an area where the alignment guide is to be mounted, the patient-specific length is a custom length based on the thickness of the patient's articular cartilage measured from a multi-dimensional image of the patient's articular cartilage;
a patient-specific surface at the second end, the patient-specific surface configured to be complementary to and closely mate with an outer bone surface of the underlying bone, the patient-specific surface is a custom surface based on a multi-dimensional image of the patient's outer bone surface;
a bone anchoring portion extending from the second end; and
a shoulder between the second end and the bone-anchoring portion, the shoulder is patient-specific and customized to the patient based on a multi-dimensional image of the patient's outer bone surface, and configured to abut and closely mate with the outer surface of the underlying bone.

25. The orthopedic device of claim 24, wherein the alignment guide includes guiding bores for guiding alignment pins.

26. The orthopedic device of claim 24, wherein the inner anatomy-engaging surface is a three-dimensional patient-specific surface including a customized shape based on a multi-dimensional image of an outer cartilage surface of the bone of the patient and configured to nestingly mate to and be mounted on the outer cartilage surface of the bone of the patient in only one direction.

27. The orthopedic device of claim 24, wherein the bone anchoring portion includes a pointed tip for penetrating bone.

28. The orthopedic device of claim 24, wherein the bone anchoring portion has a smaller diameter than the cartilage anchoring portion.