# Patent

## Title
Patient-specific-bone-cutting guidance instruments and methods

## Abstract

An orthopedic device for cutting or resurfacing an outer bone surface of a bone of a patient includes first and second guides. Each guide has a patient-specific surface preoperatively configured as a negative surface of a portion of the outer bone surface of the bone and a plurality of elongated slots. The elongated slots of the second guide are offset relative to the elongated slots of the first guide and configured for guiding a tool to resurface the outer bone surface.

## Background
CLAIM OF PRIORITY
This application is a continuation of U.S. patent application Ser. No. 14/316,993, filed on Jun. 27, 2014, which is a divisional of U.S. patent application Ser. No. 13/175,142, filed on Jul. 1, 2011, now issued as U.S. Pat. No. 8,764,760, the benefit of priority of each of which is claimed hereby, and each of which are incorporated by reference herein in its entirety.


INTRODUCTION
The present teachings provide various patient-specific guides and other instruments for guiding a cutting device to remove a small layer of cartilage and/or bone of a joint of a patient or otherwise prepare the bone for a patient-specific resurfacing implant. The present teachings also provide patient-specific guides for guiding a tool to prepare a bone for a non-custom implant. The patient-specific guides are designed and constructed preoperatively based on three-dimensional digital images of the patient's joint. The digital images of the patient's joint can be reconstructed from medical scans of the patient using commercially available CAD (Computer Aided Design) and/or other imaging software.
SUMMARY
The present teachings provide various orthopedic devices and associated methods for cutting or resurfacing an outer bone surface of a bone of a patient.
In some embodiments, the orthopedic device includes first and second resurfacing guides. Each resurfacing guide has a patient-specific surface preoperatively configured as a negative surface of a portion of the outer bone surface of the bone and a plurality of elongated slots. The elongated slots of the second guide are offset relative to the elongated slots of the first guide and configured for guiding a tool to resurface the outer bone surface.
In some embodiments, the orthopedic device includes a patient-specific annular frame preoperatively configured and contoured as a negative surface of a corresponding contour of an outer bone surface of the bone and including an opening. A first patient-specific template is configured to be removably receivable in the opening of the annular frame. The first patient-specific template has a patient-specific surface preoperatively configured as a negative surface of a portion of the outer bone surface. The first patient-specific template includes a first plurality of elongated slots. A second patient-specific template can also be configured to be removably receivable in the opening of the annular frame. The second patient-specific template includes a second plurality of elongated slots configured to be offset relative to the first plurality of elongated slots.
In a related method, the outer bone surface of the bone of the patient can be resurfaced by positioning the first patient-specific guide on the outer bone surface and guiding a cutting portion of a cutting tool through each of the first plurality of elongated slots to resurface the outer bone surface under the first plurality of elongated slots. The first patient-specific guide is removed from the outer bone surface and the second patient-specific guide is positioned on the outer bone surface to resurface the outer bone surface under the second plurality of elongated slots such that the outer bone surface is contiguously resurfaced.
In some embodiments, the orthopedic device includes a patient-specific alignment guide having a patient-specific surface preoperatively configured as a negative surface of a portion of an outer bone surface of the bone. The patient-specific alignment guide includes a guiding bore configured for inserting a reference pin into the bone. The orthopedic device includes a resurfacing instrument having a removable cutting effector with a cutting surface and a guiding member. The guiding member is connected to the resurfacing instrument and configured to removably engage the reference pin and to reference the cutting surface to the outer bone surface for cutting or resurfacing after the patient-specific alignment guide is removed. In some embodiments, the cutting surface is an abrading surface configured for removing articular cartilage from the outer bone surface. In some embodiments, the cutting surface is a patient-specific surface preoperatively configured as a negative surface of a portion of the outer bone surface of the bone of the patient. In other embodiments, the cutting surface is non-custom.
In a related method, the patient-specific surface of the patient-specific alignment guide is mated on the outer bone surface and the reference pin is inserted into the bone through the guiding bore of the patient-specific alignment guide. The patient-specific alignment guide is removed without removing the reference pin. The resurfacing instrument is coupled to the reference pin to register the resurfacing instrument relative to the outer bone surface. The cutting effector is coupled to the resurfacing instrument to resurface the outer bone surface.
In some embodiments, the orthopedic device includes a patient-specific alignment guide having a patient-specific surface preoperatively configured as a negative surface of a portion of an outer bone surface of a bone of a patient. The patient-specific alignment guide has a guiding bore configured for inserting a reference pin into the bone. The orthopedic device also includes a patient-specific resurfacing guide having an opening configured to receive the reference pin after the patient-specific alignment guide is removed from the bone. The patient-specific resurfacing guide has a patient-specific surface preoperatively configured as a negative surface of the outer bone surface, and an elongated slot communicating with a side slot. The orthopedic device includes a resurfacing tool having a shaft configured to be movably coupled to the patient-specific resurfacing guide along a sagittal plane of the bone. A patient-specific resurfacing member is coupled perpendicularly to the shaft and configured to move along a coronal plane of the bone.
In some embodiments, the orthopedic device includes a physical bone model having a patient-specific surface configured to replicate an outer bone surface of a bone of a patient; and a reconfigurable resurfacing instrument. The reconfigurable resurfacing instrument includes a movable and deformable resurfacing belt and a plurality of rollers extending from adjustable elongated elements and pushing against the resurfacing belt. The elongated elements operate to deform and set the resurfacing belt to a shape that is negative surface of the patient-specific surface of the physical bone model, when the resurfacing belt is positioned on the physical bone model.
In a related method, a three-dimensional digital image of a bone of a patient is prepared from medical scans of the patient. A physical bone model having an outer surface replicating an outer bone surface of the bone of the patient is prepared from the digital image of the bone. A reconfigurable resurfacing tool is set on the physical bone model to form a patient-specific resurfacing surface negative surface to the outer bone surface using the physical bone model.
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 drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure.
FIG. 1 is an environmental perspective view of a first patient-specific resurfacing guide according to the present teachings;
FIG. 1A is a detail of one embodiment of a patient-specific resurfacing guide according to the present teachings;
FIG. 1B is a detail of another embodiment of a patient-specific resurfacing guide according to the present teachings;
FIG. 2 is an environmental perspective view of a second patient-specific resurfacing guide according to the present teachings;
FIG. 2A is an environmental perspective view of a modular patient-specific resurfacing guide according to the present teachings;
FIG. 3 is a perspective view of a resurfacing tool for use with the first and second patient-specific guides of FIGS. 1, 2 and 2A;
FIG. 4 is an environmental perspective view of a patient-specific guide for installing a reference pin;
FIG. 5 is an environmental perspective view of the reference pin of FIG. 4 referencing a guide of cutting tool relative to the bone according to the present teachings;
FIG. 6A is an environmental view of a patient-specific cutting tool shown with the reference pin of FIG. 5 according to the present teachings;
FIG. 6B is an environmental view of another cutting tool shown with the reference pin of FIG. 5 according to the present teachings;
FIG. 7 is an environmental view of a patient-specific guide for guiding a resurfacing tool according to the present teachings;
FIG. 8 is a plan view of a resurfacing tool for use with the patient-specific guide of FIG. 7 according to the present teachings;
FIG. 9 is an environmental perspective view of the patient-specific guide of FIG. 7 shown with the resurfacing tool of FIG. 8 according to the present teachings;
FIG. 10 is a front view of a digital display of an electronic device showing a three-dimensional digital image of a bone according to the present teachings;
FIG. 11 is a perspective view of a physical bone model of a portion of the bone shown in FIG. 10 according to the present teachings;
FIG. 12 is a side view of a reconfigurable resurfacing instrument shown with the bone model of FIG. 11 according to the present teachings; and
FIG. 13 is an environmental view of the reconfigured resurfacing instrument of FIG. 12 shown with the bone imaged in FIG. 10 according to the present teachings.



Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings.
DESCRIPTION OF VARIOUS ASPECTS
The following description is merely exemplary in nature and is in no way intended to limit the present teachings, applications, or uses. For example, although some of the present teachings are illustrated for a knee joint, the present teachings can be used for any other joint of a patient in joint arthroplasty.
The present teachings provide various patient-specific guides and other instruments for guiding a cutting device to remove a small layer of cartilage and/or bone or otherwise prepare the bone for a patient-specific resurfacing implant. The present teachings also provide patient-specific guides for guiding a tool to prepare a bone for a non-custom implant. Various patient-specific guides, related tools and non-custom devices are illustrated in FIGS. 1-13 and discussed in detail below.
Generally, patient-specific devices, such as patient-specific guides or other instruments and/or patient-specific implants can be designed preoperatively using computer-assisted image methods based on three-dimensional images of the patient's joint and/or adjacent anatomy, as reconstructed from MRI, CT, ultrasound, X-ray, or other medical scans of the patient. Various CAD programs and/or other software can be utilized for the three-dimensional image reconstruction of the anatomy from the medical scans of the patient, such as, for example, software commercially available by Materialise USA, Plymouth, Mich.
Various pre-operative planning procedures and related patient-specific instruments are disclosed in commonly assigned and co-pending U.S. patent application Ser. No. 11/756,057, filed May 31, 2007; U.S. patent application Ser. No. 11/971,390, filed on Jan. 9, 2008; U.S. patent application Ser. No. 12/025,414, filed on Feb. 4, 2008; U.S. patent application Ser. No. 12/039,849 filed on Feb. 29, 2008; U.S. patent application Ser. No. 12/103,824, filed Apr. 16, 2008; U.S. patent application Ser. No. 12/371,096, filed Feb. 13, 2009; U.S. patent application Ser. No. 12/483,807, filed Jun. 12, 2009; U.S. patent application Ser. No. 12/872,663, filed Aug. 31, 2010; U.S. patent application Ser. No. 12/973,214, filed Dec. 20, 2010; and U.S. patent application Ser. No. 12/978,069, filed Dec. 23, 2010. The disclosures of the above applications are incorporated herein by reference.
In the preoperative planning stage for joint reconstruction, resurfacing or replacement, a preoperative surgical plan is formulated for a specific patient with optional interactive input from the patient's surgeon or other medical professional. Imaging data from medical scans of the relevant anatomy of the patient can be obtained at a medical facility or doctor's office, using any of the medical imaging methods discussed above. The imaging data can include, for example, various medical scans of a relevant joint portion or other relevant portion of the patient's anatomy, as needed for joint or other anatomy modeling and, optionally, for determination of an implant alignment axis or for other alignment purposes. The imaging data thus obtained and other associated information can be used to construct a three-dimensional computer (digital) image of the joint or other portion of the anatomy of the patient, such as, for example, the bones of a knee joint, hip joint, shoulder joint, etc. The three-dimensional digital image of the patient's anatomy is used to formulate the preoperative surgical plan for the patient. The preoperative surgical plan includes the design and construction of patient-specific guides, instruments and/or implants or the selection of non-custom implants and instruments according to surgeon-selected methods of surgical preparation and implantation.
Generally, the patient-specific guides or other instruments (patient-specific devices, for short) of the present teachings are preoperatively configured to match the surface of a bone (with or without cartilage) of a joint of a specific patient and are generally designed and preoperatively configured using computer modeling based on the patient's reconstructed three-dimensional digital image of the patient's pelvic anatomy. A patient-specific device has a bone engagement surface that is preoperatively configured to conformingly contact and match the corresponding bone surface of the patient (with or without cartilage or other soft tissue), using the reconstructed three-dimensional digital image of the patient's joint anatomy and the computer methods discussed above. In this respect, a patient-specific device can register and nestingly mate with the corresponding bone surface (with or without articular cartilage) of the specific patient in only one position. Accordingly, the patient-specific surface is preoperatively configured as an inverse or mirror or negative or a complementary surface of an outer surface of the corresponding bone, with or without cartilage.
The three-dimensional model of the patient's anatomy can be viewed on a computer display or other electronic screen and can also be reproduced as a hard copy on film or other medium and viewed by direct or indirect or backlight illumination. The model can be sized for viewing on any appropriate screen size and may be cropped, rotated, etc., as selected by the individual (e.g., the surgeon) viewing the screen.
The patient-specific devices can be manufactured by rapid prototyping methods, such as stereolithography or other similar methods or by CNC milling, or other automated or computer-controlled machining or robotic methods. The patient-specific devices, the implants and optionally other disposable instruments can be packaged and sterilized, and forwarded in a patient- and/or surgeon-specific kit to the surgeon or the surgeon's medical facility for the corresponding orthopedic procedure.
Referring to FIGS. 1 and 2, first and second patient-specific resurfacing guides 100A and 100B are illustrated for resurfacing an outer bone surface 83 of a bone 80 of a patient's joint. In this exemplary illustration, the bone 80 is shown as a distal femur of a knee joint, although the present teachings are applicable for resurfacing the bone of any other joint. Each patient-specific resurfacing guide 100A, 100B, has a first or inner patient-specific surface 102A, 102B closely mating in a complementary manner and registering with the outer bone surface 83 of the bone 80 only in one position. In other words, each first patient-specific surface 102A, 102B is preoperatively configured as an inverse or mirror or negative of the outer bone surface 83 of the bone 80 (with or without cartilage). Each patient-specific resurfacing guide 100A, 100B, has a second or outer surface 107A, 107B opposite to the first patient-specific surface 102A, 102B. Referring to FIG. 1A, the outer surface 107A, 107B can be patient-specific and parallel to the inner patient-specific surface 102A, 102B for guiding a cutting (or resurfacing) tool 200, such as the tool shown in FIG. 3, to cut or resurface the bone 80 for a patient-specific implant, i.e., such that the resurfaced outer bone surface maintains its patient-specific shape and still has the same negative surface. In some embodiments, the outer surface 107A, 107B can be non-custom, with planar surfaces for guiding the cutting tool 200 to make planar resections for engaging the planar or multi-planar inner surface of a non-custom implant, as shown in FIG. 1B. Each patient-specific resurfacing guide 100A, 100B includes a corresponding plurality of elongated slots 104A, 104B for guiding the cutting (or resurfacing) tool 200. The elongated slots 104B of the second patient-specific resurfacing guide 100B are offset and/or overlapping relative to the elongated slots 104A of the first patient-specific resurfacing guide 100A, such that the entire outer bone surface 83 of the bone 80 can be resurfaced contiguously for receiving an implant by using the first and second patient-specific resurfacing guides 100A, 100B consecutively.
Referring to FIGS. 1-3, the first patient-specific resurfacing guide 100A can be registered on the bone 80 and the cutting tool 200 can be guided by the elongated slots 104A to remove cartilage (with or without removing any underlying bone) under the elongated slots 104A from the outer bone surface 83, such as, for example, from the first and second (medial or lateral) femoral condyles 82, 84 of a distal femoral bone 80. After the outer bone surface 83 under the elongated slots 104A of the first patient-specific resurfacing guide 100A has been prepared, the first patient-specific resurfacing guide 100A can be removed and the remaining cartilage or unfinished outer bone surface 83 can be finished or resurfaced either by free-hand use of the cutting tool 200 or other cutting tool or by using the second patient-specific resurfacing guide 100B. The elongated slots 104B of the second patient-specific resurfacing guide 100B overlap the location of the elongated slots 104A of the first patient-specific resurfacing guide 100A, such that the entire outer bone surface 83 can be prepared by sequentially using the cutting tool 200 through the corresponding elongated slots 104A, 104B of the first and second patient-specific resurfacing guides 100A, 100B. The patient-specific resurfacing guides 100A, 100B can also be secured on the bone 80 with pins, K-wires or other fasteners (not shown).
Referring to FIG. 2A, in some embodiments, the patient-specific resurfacing guides can be modular and include of a patient-specific annular frame 100C having an opening 103 and one or more patient-specific cutting templates 150, 150′ that can be received in the opening 103 and snap-fit or otherwise be removably coupled to the patient-specific annular frame 100C. The patient-specific annular frame 100C can be preoperatively contoured as a negative or mirror of the corresponding contour (or curved surface strip) of a portion of the outer bone surface 83 of the bone 80 to be resurfaced. In some embodiments, the cutting template 150 can be designed as a partial cutting template to cover only a portion of the opening 103 (partial template 150) and one or more additional partial templates 150′ can be designed to be received in the remainder of the opening 103. In the exemplary illustration of FIG. 2A, two partial cutting templates 150, 150′ can be positioned one adjacent to the other to occupy the opening 103, although a single cutting template can be also used for the entire opening 103. The patient-specific annular frame 100C can include a first or inner patient-specific bone engagement surface 102C that can register in only bone position on the outer bone surface 83 and an opposite (outer or second) surface 107C that can be either patient-specific and parallel to the inner patient-specific surface 102C or non-patient-specific with planar or multiplanar portions as discussed above. The patient-specific cutting templates 150, 150′ can also include corresponding patient-specific bone engagement surface 152, 152′ that register in only bone position on the outer bone surface 83. Each of the patient-specific surfaces 152, 152′ is preoperatively configured as an inverse or mirror or negative of outer bone surface 83, with or without cartilage.
The patient-specific cutting templates 150, 150′ can include a plurality of elongated slots 154, 154′ for guiding a tool, such as the cutting tool 200 shown in FIG. 3. Each patient-specific cutting template 150, 150′ can be removed and replaced with a similar second template having elongated slots that are offset and/or overlap relative to the slots 154, 154′, as discussed above in connection with unitary patient-specific resurfacing guides 100A, 100B. In some embodiments, a plurality (two or more) of partial cutting templates similar to the templates 150, 150′ can be used. In some embodiments, one or more partial cutting templates 150, 150′ can slide in the medial-lateral direction by a small offset, such that the outer bone surface 83 under the corresponding partial cutting template 150, 150′ can be resurfaced for receiving an implant without using additional partial templates with offset elongated slots relative to the elongated slots 154, 154′. A slidable partial cutting template can have a mediolateral dimension that is sufficiently small such that it can slide relative to the outer bone surface 83 while having a substantially patent-specific surface. The patient-specific annular frame 1000 and, optionally, the patient-specific cutting templates 150, 150′ can be secured on the bone 80 with pins, K-wires or other fasteners (not shown).
Referring to FIG. 3, the cutting tool 200 can include a handle 202 and a cutting portion 204, such as, for example, a burr or mill cutter. The cutting tool 200 can include a depth stop 206 that can abut the outer surface 107A, 107B, opposite to the inner patient-specific surface 102A, 102B of the patient-specific resurfacing guide 100A, 100B and limit the penetration of the cutting portion 204 into the bone 80 through the corresponding elongated slots 104A, 104B. The cutting portion 204 can be preoperatively configured for removing cartilage and creating a finished or resurfaced contoured surface of the bone 80 for receiving, for example, a patient-specific implant. In other embodiments, the cutting portion 204 can also be preoperatively configured to create a planar surface for receiving a non-custom implant having a planar or multi-planar bone-engaging surface.
Referring to FIGS. 4-6B, another bone preparation procedure and associated instruments are illustrated according to the present teachings. Briefly, a patient-specific alignment guide 300 is configured for registration (i.e., positionable by design in only one position) on the outer bone surface 83 for installing a reference pin 410 on the bone 80, as shown in FIG. 4. Patient-specific alignment guides for positioning reference or alignment pins are also disclosed in the above-referenced and incorporated herein patent applications and in commonly assigned and co-pending U.S. patent application Ser. No. 12/955,361, filed Nov. 29, 2010, and incorporated herein by reference. The reference pin 410 can be used to guide a resurfacing instrument 400 operable to remove cartilage and/or bone using a cutting surface 466 of a cutting effector 460 of the resurfacing instrument 400. The cutting surface 466 can be patient-specific, as illustrated in FIG. 6A, for removing cartilage and preparing the outer bone surface 83 for receiving a patient-specific implant. Alternatively, a cutting effector 460′ with a cutting surface 466′ can be coupled to the resurfacing instrument 400. The cutting effector 460′ can be non-custom and configured for removing cartilage and bone and preparing planar bone faces for a non-custom implant that has a corresponding planar or multi-planar bone engaging surface.
More specifically, and with continued reference to FIGS. 4-6B, the patient-specific alignment guide 300 can be configured preoperatively to include a patient-specific engagement surface 314 that is complementary and made to closely conform and mate (as inverse, negative or mirror surface) with a portion of the patient's bone 80 (the anterior-distal outer bone surface 83 of the patient's femur 80 in the exemplary illustration of FIG. 4) based on the pre-operative plan, as described above. The patient-specific alignment guide 300 can be lightweight and include a window/opening 315 and first and second distal guiding formations 312a, 312b defining guiding bores 313 for receiving fixation pins and/or guiding corresponding distal alignment pins (not shown). The patient-specific alignment guide 300 can also include either a pair or, as shown in FIG. 4, a single anterior guiding formation 312c defining a guiding bore 313 for guiding corresponding anterior alignment or reference pin 410 along an alignment direction A. The alignment direction A can be determined preoperatively for placing the cutting surface 466 of the resurfacing instrument 400 in a preoperatively determined position in reference to the outer bone surface 83 of the bone 80. Specifically, the reference pin 410 can be used as a guide after the patient-specific alignment guide 300 has been removed, as shown in FIGS. 5, 6A and 6B. The patient-specific alignment guide 300 can be secured on the bone 80 with pins, K-wires or other fasteners (not shown).
With continued reference to FIGS. 5, 6A and 6B, the resurfacing instrument 400 can include a curved or angled guiding member 402 with a distal portion 404 that is preoperatively configured to be aligned along the alignment direction A when the distal portion 404 is coupled to the reference pin 410. A proximal portion 403 of the guiding member 402 can be received in a bore 452 of a guide tube 450 or otherwise connected to the guide tube 450. The guide tube 450 can be coupled to a holder 480 of the resurfacing instrument 400 using a connector 454. The connector 454 can be integrally or removably coupled to the guide tube 450 and to the holder 480, such that when the guiding member 402 is coupled to the reference pin 410, the holder 480 is oriented to position the cutting effector 460 for resurfacing the outer bone surface 83 of the bone 80, as described above. The cutting effector 460 can be removably coupled to the holder 480 with a shaft 468. The cutting effector 460 can be, for example, a vibratory cutter, as illustrated in FIGS. 6A and 6B, or a cutter with a burr or milling head or other type of cutting tool, including, for example, the resurfacing member 600 shown in FIG. 8, and discussed below in relation to another embodiment illustrated in FIGS. 7-9. The cutting effector 460 can be operated through a connection to an external power source or to internal power source (battery).
In the illustrative embodiment of FIG. 6A, the cutting effector 460 can include a patient-specific support surface 464 preoperatively configured to mirror (as a negative or inverse surface) the outer bone surface 83 (or portion thereof) of the bone 80 to be resurfaced. The patient-specific support surface 464 can be a supporting surface coupled to grinding (or cutting) elements 462. In the patient-specific embodiment of FIG. 6A, the endpoints of the grinding elements 462 can form a patient-specific cutting surface 466 parallel to patient-specific support surface 464 and mirroring (negative or inverse surface) the outer bone surface 83 for removing cartilage. Although the grinding elements 462 are shown in exaggeration as teeth, in the embodiment of FIG. 6A the grinding elements 462 can be grit-like and attached to the patient-specific support surface 464. A suction device (not shown) can be also attached to the holder 480 and provide suction to remove the cartilage particles or other resurfacing debris through a bore of the shaft 468.
Referring to FIG. 6B, the non-custom cutting effector 460′ can be removably coupled to the holder 480 via a shaft 468′. The cutting effector 460′ can include a planar or piecewise planar (multi-planar) support surface 464′ that includes cutting elements 462′ in the form of cutting teeth or cutting blade elements. The cutting elements 462′ can form a cutting surface 466′ parallel to the support surface 464′ and can cut planar surfaces through the bone 80 corresponding to the planes of the support surface 464′, removing both cartilage and bone material for preparing the outer bone surface 83 for a non-custom implant having planar bone engaging interior faces.
Referring to FIGS. 7-9, another bone surface preparation procedure and associated instruments according to the present teachings are illustrated. In this embodiment, the patient-specific alignment guide 300 of FIG. 4 or a similar patient-specific alignment guide is registered on the outer bone surface 83 of the bone 80 and used to guide and insert a reference pin 410 into the bone 80. The patent-specific alignment guide 300 is then removed, and the reference pin 410 is used to guide and position a patient-specific resurfacing guide 500 on the outer bone surface 83, as shown in FIG. 7. The patient-specific resurfacing guide 500 can guide a resurfacing or cutting tool 650 to remove cartilage and/or bone from the outer bone surface 83 in preparation for an implant, as shown in FIGS. 8 and 9 and discussed below.
More specifically and with continued reference to FIGS. 7-9, the patient-specific resurfacing guide 500 has a hole or other opening 504 for receiving the reference pin 410 and a patient-specific surface 502. The patient-specific surface 502 can be preoperatively configured to mirror (as a negative or inverse or complementary surface) and mate with a corresponding portion of the outer bone surface 83 of the bone 80. The reference pin 410 facilitates the registration of the patient-specific resurfacing guide 500, such that the patient-specific resurfacing guide 500 can have a small width relative to the width of the portion of the outer bone surface 83 to be resurfaced. Resurfacing can be effected on each side of the patient-specific resurfacing guide 500 simultaneously or sequentially. For example, when the bone 80 is a distal femur, the patient-specific resurfacing guide 500 can have a narrow width in the mediolateral direction and track a narrow area between the first and second (medial or lateral) femoral condyles 82, 84, such that first and second femoral condyles 82, 84 can be exposed for either simultaneous or sequential resurfacing, as discussed below.
The patient-specific resurfacing guide 500 can include an external elongated slot 520 along the sagittal plane of the bone 80. The elongated slot 520 defines a pair of side openings 522 (one of the pair is hidden from view in FIG. 9). The elongated slot 520 can guide the resurfacing tool 650 to resurface the outer bone surface 83. The resurfacing tool 650 can include a resurfacing member 600 and can be movably coupled and guided by the elongated slot 520 such that the resurfacing member 600 can remove articular cartilage from the bone 80 or otherwise prepare the outer bone surface 83 for receiving an implant. The resurfacing tool 650 can include a handle 653 and a shaft 652 coupled to the handle 653. The shaft 652 can be received in the slot 520 and move in the sagittal plane of the bone 80 (perpendicularly to the bone 80) along the slot 520. The resurfacing member 600 can be coupled to a rod or peg 654 that can pass through the side opening 522. The peg 654 can be removably coupled to the shaft 652 and oriented perpendicularly to the shaft 652. The resurfacing member 600 can have a resurfacing (cutting or abrading) surface 602 that matches and engages the outer bone surface 83. The resurfacing surface 602 can be patient-specific and configured during the preoperative plan of the patient to conform in mirror-image fashion with the outer bone surface 83 (with or without cartilage, depending on the procedure), as reconstructed in three-dimensional digital image from medical scans of the bone 80 of the patient.
The resurfacing member 600 can be coupled to the resurfacing tool 650 on one side of the patient-specific resurfacing guide 500 for resurfacing a corresponding side of the outer bone surface 83, such as the femoral condyle 84 in the illustration of FIG. 9. The resurfacing member 600 can then be removed and another resurfacing member 600 preoperatively configured to be patient-specific to the outer bone surface 83 of the opposite side of the patient-specific resurfacing guide 500 (femoral condyle 82) can be coupled to resurfacing tool 650 for completing the resurfacing of the outer bone surface 83. In some embodiments, a pair of resurfacing members 600, one on each side of the patient-specific resurfacing guide 500, can be coupled simultaneously, rather than sequentially, to the resurfacing tool 650.
Referring to FIGS. 10-13, a method for creating preoperatively a reconfigurable resurfacing or cutting instrument 800 is illustrated. The reconfigurable resurfacing instrument 800 can be reconfigured or “set” for each patient to take a patient-specific resurfacing shape. A three-dimensional digital image 80i of the patient's bone 80 can be reconstructed from medical scans of the patient using commercially available imaging software, as discussed above. The digital image 80i can be displayed on an electronic display 72 of a computer, computer terminal, portable or handheld tablet, mobile, cellular or other electronic device 70 equipped with a processor or communicating with a processor that runs the imaging software, as shown in FIG. 10. The digital image 80i can have a digital outer surface 83i corresponding to the outer bone surface 83, including, in the exemplary illustration of FIG. 10, digital femoral condyle images 82i, 84i. 
Referring to FIGS. 11-13, a patient-specific physical (not electronic) bone replica or model 700 can be created preoperatively from the digital image 80i using, for example, rapid prototyping, stereolithography or other manufacturing methods. The physical bone model 700 can have an outer surface 702 that replicates (is a copy of) the outer bone surface 83 (same as the digital outer surface 83i). The physical bone model 700 can be used as a setting surface to create and set an inverse shape on a movable and deformable resurfacing belt 880 of the reconfigurable resurfacing instrument 800 for removing cartilage from or otherwise abrading the outer bone surface 83 of the bone 80, as shown in FIG. 13.
The reconfigurable resurfacing instrument 800 can include a handle 802 and a frame 806 supporting the resurfacing belt 880 around pulleys 870 extending from the frame 806. A shaft 804 can couple the handle 802 to the frame 806. A plurality of rollers 822 can be connected to the frame 806 with adjustable, retractable, telescopic or spring-biased elongated elements 820, such as rods or bars. The adjustable elongated elements 820 can be spring-loaded against the resurfacing belt 880, such that when the resurfacing belt 880 is pushed against the outer surface 702 of the physical bone model 700, the lengths of the adjustable elongated elements 820 can change to allow the resurfacing belt 880 to deform and take the shape of a negative surface of the outer surface 702. The adjustable elongated elements 820 can then be locked at this configuration that sets the resurfacing belt 880 to a shape negative to the shape of the outer surface 702 of the physical bone model 700 that corresponds to the patient's bone 80, as discussed above. The reconfigurable resurfacing instrument 800 can be preoperatively reconfigured for a different patient using a new physical bone model 700 that is specific to the new patient. The resurfacing belt 880 is removable and can also be sterilizable and reusable, or can be a single-use disposable resurfacing belt 880.
In some embodiments, the resurfacing belt 880 can have a width (the dimension perpendicular to the side view of FIG. 12, or mediolateral dimension) sufficient to cover the entire outer surface 702 in FIG. 11, with the corresponding rollers 822 and elongated elements 820 arranged in a three-dimensional array. In other embodiments, the resurfacing belt 880 can have a width covering only a strip of the outer surface 702, with the corresponding rollers 822 and elongated elements 820 arranged in a two-dimensional array. In yet other embodiments, the width of the resurfacing belt 880 can be sufficient to resurface one of the femoral condyles (shown as 82i, 84i in the digital bone image 80i of FIG. 10). A narrow width of the resurfacing belt 880 can be selected for stability and ease of use. In such cases, the resurfacing belt 880 can also be reconfigured intraoperatively, as needed or at the surgeon's discretion, using the patient-specific bone model 700 for resurfacing other remaining portions of the outer bone surface 83. The physical bone model 700 can be included in the surgical kit for the specific patient, such that the reconfigurable resurfacing instrument 800 can be reconfigured intraoperatively to resurface additional portions of the outer bone surface 83 at the surgeon's discretion.
Referring to FIG. 13, in some embodiments the reconfigurable resurfacing instrument 800 can be additionally referenced to the bone 80 using a reference pin 810, which can be inserted into the bone 80 using a patient-specific alignment guide, such as the patient-specific alignment guide 300 shown with reference pin 410 and discussed above in connection with FIG. 4. The reconfigurable resurfacing instrument 800 can be registered to the reference pin 810 through a fixed or removable extension 830. Another reference pin 810 can also be placed in a patient-specific location and orientation in the physical bone model 700. For example, a pin-receiving bore for receiving the reference pin 810 can be incorporated in the physical bone model 700 in a preoperatively determined location and orientation. In some embodiments, instead of a resurfacing belt 880 other cutting elements can be used. For example, when the resurfacing belt 880 is not used, the rollers 822 can be replaced by cutting wheels (also referenced 822) at the distal ends of the elongated elements 820, such that the cutting wheels 822 define a boundary surface (or envelope surface) that is negative to the outer bone surface 83. In this respect, a sufficient number of cutting wheels 822 is used to contact and resurface the outer bone surface 83.
As discussed above, the present teachings provide various patient-specific guides and other instruments for guiding a cutting device to remove a small layer of cartilage and/or bone or otherwise prepare the bone for a patient-specific resurfacing implant or for a non-custom replacement implant. It is contemplated that elements and components shown in one exemplary embodiment can also be used in another embodiment. Further, the methods and devices described herein can be used for a bone surface of any joint, including knee, hip, shoulder, etc. The various devices and methods of the present teachings can be used to resurface an articular bone surface by removing cartilage or cartilage and a layer of underlying bone in orthopedic resurfacing procedures. Alternatively, the bone surface can be cut to remove bone and any overlying cartilage in preparation for implantation of a non-custom implant in orthopedic replacement procedures.
Example embodiments are provided so that this disclosure is thorough, and fully conveys the scope to those who are skilled in the art. Numerous specific details are set forth such as examples of specific components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure.
It will be apparent to those skilled in the art that specific details need not be employed, that example embodiments may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. In some example embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail. Accordingly, individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but, where applicable, are interchangeable and can be used in a selected embodiment, even if not specifically shown or described. The same may also be varied in many ways. Such variations are not to be regarded as a departure from the disclosure, and all such modifications are intended to be included within the scope of the disclosure.

## Claims

1. A patient-specific alignment guide system for cutting or resurfacing an outer bone surface of a bone of a patient, the alignment guide system comprising:
a patient-specific alignment guide having an engagement surface mirroring the outer bone surface;
a first guiding formation connected to the alignment guide on a non-engaging surface to direct a reference pin into the bone at a desired location;
a reference pin configured to extend through the first guiding formation; and
a cutting effector system comprising:
a vibratory cutting tool having a patient-specific cutting support surface mirroring the outer bone surface and a patient-specific cutting surface including grinding elements;
a guide member for coupling to the reference pin, the guide member comprising an angled guiding shaft having a distal portion angled with respect to a proximal portion; and
a guide connecting the vibratory cutting tool and the guide member, the guide comprising:
a guide tube slidably engaged with the proximal portion of the angled guiding shaft; and
a connector extending from the guide tube and connected to the vibratory cutting tool:
wherein the angled guiding shaft and the connector are sized and shaped so that the guide tube can be translated on the proximal portion of the angled guiding shaft so that the patient-specific cutting surface can engage the outer bone surface that is mirrored by the patient-specific cutting support surface; and
wherein the guide is translatable on the guide member to bring the cutting surface into engagement with the outer bone surface.

2. The patient-specific alignment guide system of claim 1, further comprising a second guiding formation connected to the alignment guide on the non-engaging surface to direct a reference pin into the bone at a second desired location.

3. The patient-specific alignment guide system of claim 2, wherein the first guiding formation comprises an anterior guiding formation for locating on an anterior surface of a femur between condyles, and the second guiding formation comprises a distal guiding formation for locating on a distal surface of a condyle of the femur.

4. The patient-specific alignment guide system of claim 1, wherein the patient-specific alignment guide includes a window located entirely within an outer boundary of the patient-specific alignment guide.

5. A cutting effector system for cutting or resurfacing an outer bone surface of a bone of a patient, the cutting effector system comprising:
a vibratory cutting tool having a patient-specific cutting surface preoperatively configured to three-dimensionally mirror a three-dimensional digital image of the outer bone surface;
a guide member having a reference pin for insertion into the bone at a patient-specific location; and
a guide connecting the vibratory cutting tool and the guide member; wherein the guide is translatable on the guide member to bring the patient-specific cutting surface into engagement with the outer bone surface that is mirrored by the patient-specific cutting surface.

6. The cutting effector system of claim 5, wherein the vibratory cutting tool comprises:
a patient-specific support surface; and
grinding elements located on the patient-specific cutting surface.

7. The cutting effector system of claim 6, wherein the vibratory cutting tool further comprises:
a shaft extending from the patient-specific support surface; and
a holder connected to the shaft and the guide.

8. The cutting effector system of claim 5, wherein the guide member comprises:
an angled guiding shaft having a distal portion angled with respect to a proximal portion;
wherein the reference pin is located at the distal portion of the angled guiding shaft.

9. The cutting effector of claim 5, wherein the guide comprises:
a guide tube slidably engaged with the proximal portion of the angled guiding shaft; and
a connector extending from the guide tube and connected to the holder; wherein the angled guiding shaft and the connector are sized and shaped so that guide tube can be translated on the proximal portion of the angled guiding shaft so that the patient-specific cutting surface can engage the outer bone surface that is mirrored by the patient-specific cutting surface.

10. A patient-specific cutting system for cutting or resurfacing an outer bone surface of a bone of a patient, the cutting system comprising:
a patient-specific resurfacing guide comprising:
a guide surface configured to mirror and mate with a corresponding portion of the outer bone surface;
a slot extending along the patient-specific resurfacing guide; and
an elongated opening extending into the patient-specific resurfacing guide that intersects the slot; and

a resurfacing tool configured to ride in the slot to resurface the outer bone surface adjacent the guide surface.

11. The patient-specific cutting system of claim 10, wherein the guide surface of the patient-specific resurfacing guide is configured to track a narrow area between medial and lateral condyles of the bone.

12. The patient-specific cutting system of claim 10, wherein the patient-specific resurfacing guide includes a pin opening configured to receive a guide pin.

13. The patient-specific cutting system of claim 12, further comprising a guide pin configured to be inserted into the pin opening.

14. The patient-specific cutting system of claim 10, wherein the resurfacing tool comprises:
a shaft configured to ride in the slot;
a peg extending from the shaft and configured to ride in the elongated opening; and
a resurfacing member mounted to the peg outside of the patient-specific resurfacing guide, the resurfacing member including a patient-specific resurfacing surface.

15. The patient-specific cutting system of claim 14, wherein the patient-specific resurfacing surface is configured to resurface a condyle.

16. A patient-specific alignment guide system for cutting or resurfacing an outer bone surface of a bone of a patient, the alignment guide system comprising:
a patient-specific alignment guide having an engagement surface mirroring the outer bone surface;
a first guiding formation connected to the alignment guide on a non-engaging surface to direct a reference pin into the bone at a desired location;
a reference pin configured to extend through the first guiding formation; and
a patient-specific cutting system comprising:
a patient-specific resurfacing guide comprising:
a guide surface configured to mirror and mate with a corresponding portion of the outer bone surface;
a slot extending along the patient-specific resurfacing guide; and
an elongated opening extending into the patient-specific resurfacing guide that intersects the slot; and

a resurfacing tool configured to ride in the slot to resurface the outer bone surface adjacent the guide surface, the resurfacing tool comprising:
a shaft configured to ride in the slot;
a peg extending from the shaft and configured to ride in the elongated opening; and
a resurfacing member mounted to the peg outside of the patient-specific resurfacing guide, the resurfacing member including a patient-specific resurfacing surface.