# Patent

## Title
System and method for association of a guiding aid with a patient tissue

## Abstract

A patient tissue includes a primary patient tissue area and an anatomically differentiated bordering secondary patient tissue area. An apparatus is at least partially customized responsive to preoperative imaging of the patient tissue. Means are provided for mating with the primary patient tissue area in a preselected relative orientation. Means are provided for fixing a first landmark to the primary patient tissue area in at least one of a predetermined marking location and a predetermined marking trajectory. Means are provided for fixing a second landmark to the secondary patient tissue area in at least one of a predetermined marking location and a predetermined marking trajectory. A method of associating a plurality of landmarks with a patient tissue is also provided.

## Background
RELATED APPLICATION
This application claims priority from U.S. Provisional Application No. 61/408,359, filed Oct. 29, 2010, the subject matter of which is incorporated herein by reference in its entirety.


TECHNICAL FIELD
The present invention relates to a system and method for association of a guiding aid with a patient tissue and, more particularly, to a system and method for associating at least one landmark with the patient tissue for assisting with attachment of a stock prosthetic implant to the patient tissue.
BACKGROUND OF THE INVENTION
In the installation of a prosthetic shoulder joint into a patient's body, a glenoid component is implanted into the glenoid vault of the patient's scapula. An obverse surface of the glenoid component is configured for articulating contact with a humeral component carried by the patient's humerus. A reverse surface of the glenoid component is secured to the bone surface of the glenoid vault.
Because the shoulder prosthesis is normally provided to correct a congenital or acquired defect of the native shoulder joint, the glenoid vault often exhibits a pathologic, nonstandard anatomic configuration. A surgeon must compensate for such pathologic glenoid vault anatomy when implanting the glenoid component in striving to achieve a solid anchoring of the glenoid component into the glenoid vault. Detailed preoperative planning, using two- or three-dimensional internal images of the shoulder joint, often assists the surgeon in compensating for the patient's anatomical limitations. During the surgery, an elongated pin may be inserted into the surface of the patient's bone, at a predetermined trajectory and location, to act as a passive landmark or active guiding structure in carrying out the preoperatively planned implantation. This “guide pin” may remain as a portion of the implanted prosthetic joint or may be removed before the surgery is concluded. This type of pin-guided installation is common in any joint replacement procedure—indeed, in any type of surgical procedure in which a surgeon-placed fixed landmark is desirable.
In addition, and again in any type of surgical procedure, modern minimally invasive surgical techniques may dictate that only a small portion of the bone or other tissue surface being operated upon is visible to the surgeon. Depending upon the patient's particular anatomy, the surgeon may not be able to precisely determine the location of the exposed area relative to the remaining, obscured portions of the bone through mere visual observation. Again, a guide pin may be temporarily or permanently placed into the exposed bone surface to help orient the surgeon and thereby enhance the accuracy and efficiency of the surgical procedure.
A carefully placed guide pin or other landmark, regardless of the reason provided, will reduce the need for intraoperative imaging in most surgical procedures and should result in decreased operative time and increased positional accuracy, all of which are desirable in striving toward a positive patient outcome.
SUMMARY OF THE INVENTION
In an embodiment of the present invention, an apparatus for associating a plurality of landmarks with a patient tissue is described. The patient tissue includes a primary patient tissue area and an anatomically differentiated bordering secondary patient tissue area. The apparatus is at least partially customized responsive to preoperative imaging of the patient tissue. Means are provided for mating with the primary patient tissue area in a preselected relative orientation. Means are provided for fixing a first landmark to the primary patient tissue area in at least one of a predetermined marking location and a predetermined marking trajectory. Means are provided for fixing a second landmark to the secondary patient tissue area in at least one of a predetermined marking location and a predetermined marking trajectory.
In an embodiment of the present invention, an apparatus for associating a plurality of landmarks with a patient tissue is described. Each landmark is associated with the patient tissue in at least one of a predetermined marking location and a predetermined marking trajectory. The patient tissue includes a primary patient tissue area and an anatomically differentiated bordering secondary patient tissue area. The apparatus is at least partially customized responsive to preoperative imaging of the patient tissue. A base has a lower base surface contoured to mate with both the primary and secondary patient tissue areas in a preselected relative orientation. The lower base surface is spaced apart from an upper base surface by a base body. A plurality of base apertures extend between the upper and lower base surfaces through the base body. A plurality of guiding bosses protrude from the base. Each guiding boss has a guiding bore extending therethrough. Each guiding bore extends collinearly with a corresponding base aperture to permit insertion of a landmark through the apparatus. Each guiding bore and corresponding base aperture cooperatively define at least one of the predetermined marking location and the predetermined marking trajectory for the landmark. At least one landmark is guided by the apparatus into engagement with a marking location in the primary patient tissue area and at least one landmark is guided by the apparatus into engagement with a marking location in the secondary patient tissue area.
In an embodiment of the present invention, an apparatus for associating a plurality of landmarks with a patient tissue is described. Each landmark is associated with the patient tissue in at least one of a predetermined marking location and a predetermined marking trajectory. The patient tissue includes a primary patient tissue area and an anatomically differentiated bordering secondary patient tissue area. The apparatus is at least partially customized responsive to preoperative imaging of the patient tissue. A base has a lower base surface contoured to mate with the primary patient tissue area in a preselected relative orientation. The lower base surface is spaced apart from an upper base surface by a base body. A stem has longitudinally separated first and second stem ends. The first stem end is attached directly to the base and the stem extends upward from the base. At least one spacing arm is attached directly to the second stem end. Each spacing arm is longitudinally spaced from the base and has an arm guide aperture laterally spaced from the stem. The arm guide aperture is configured to guide placement of a landmark inserted at least partially therethrough in at least one of the predetermined marking location and the predetermined marking trajectory. The marking location is in the secondary patient tissue area.
In an embodiment of the present invention, a method of associating a plurality of landmarks with a patient tissue is described. Each landmark is associated with the patient tissue in at least one of a predetermined marking location and a predetermined marking trajectory. The patient tissue includes a primary patient tissue area and an anatomically differentiated bordering secondary patient tissue area. A landmark guide having a base at least partially customized responsive to preoperative imaging of the patient tissue is provided. The base has a lower base surface contoured to mate with the primary patient tissue area in a preselected relative orientation. The base of the landmark guide is mated with the primary patient tissue area in a preselected relative orientation. A first landmark is fixed to the primary patient tissue area in at least one of the predetermined marking location and the predetermined marking trajectory. A second landmark is fixed to the secondary patient tissue area in at least one of the predetermined marking location and the predetermined marking trajectory.
In an embodiment of the present invention, an apparatus for associating a plurality of landmarks with a patient tissue is described. Each landmark is associated with the patient tissue in at least one of a predetermined marking location and a predetermined marking trajectory. The removal of a predetermined amount of resection patient tissue and rearrangement of a remaining patient tissue is guided. The apparatus is at least partially customized responsive to preoperative imaging of the patient tissue. A first guide is configured to contact the resection patient tissue and the remaining patient tissue and to guide surgical contact with the patient tissue. A first guide base has a lower first guide base surface contoured to mate with both the resection and remaining patient tissues in a preselected relative orientation. The lower first guide base surface is spaced apart from an upper first guide base surface by a first guide base body. At least one first guide landmark guiding aperture extends between the upper and lower first guide base surfaces through the first guide base body to permit insertion of at least one landmark therethrough. A plurality of first guide cutting guide apertures extend between the upper and lower first guide base surfaces through the first guide base body to permit penetration of at least one cutting tool through the first guide. At least one of the first guide landmark guiding apertures defines at least one of the predetermined marking location and the predetermined marking trajectory for a first landmark and a plurality of the first guide cutting guide apertures each defines at least one cutting plane location and orientation for a cutting tool to make at least one resection cut into the patient tissue. The first guide is configured to cut the resection patient tissue for removal from the remaining patient tissue.



BRIEF DESCRIPTION OF THE DRAWINGS
For a better understanding of the invention, reference may be made to the accompanying drawings, in which:
FIG. 1 is a side view of a first example use environment;
FIG. 2 is a front view of the example use environment of FIG. 1;
FIG. 3 is a partial perspective view of the example use environment of FIG. 1;
FIG. 4 is a top view of an embodiment of the present invention;
FIG. 5 is a perspective bottom view of the embodiment of FIG. 4 from a first side;
FIG. 6 is a perspective bottom view of the embodiment of FIG. 4 from a second side;
FIG. 7 is a perspective top view of the embodiment of FIG. 4 from the second side;
FIGS. 8-10 are example user views of a program for generating the embodiment of FIG. 4;
FIG. 11 is a front view of the embodiment of FIG. 4 in a second configuration;
FIG. 12 is a front view of the embodiment of FIG. 11 in a second configuration in the example use environment of FIG. 2;
FIG. 13 is a top view of the embodiment of FIG. 4 in a third configuration;
FIG. 14 is a top view of the embodiment of FIG. 4 in a fourth configuration;
FIG. 15 is a top view of the embodiment of FIG. 4 in a fifth configuration;
FIG. 16 is a top view of a second example use environment;
FIG. 17 is a top view of an embodiment of the present invention;
FIG. 18 is a top view of the use environment of FIG. 16 as modified through the use of the embodiment of FIG. 17;
FIG. 19 is a side view of the embodiment of FIG. 17 in a second configuration;
FIG. 20 is a partial bottom view of the embodiment of FIG. 19;
FIG. 21 is a schematic side view of the embodiment of FIG. 19 in the use environment of FIG. 16;
FIG. 22 is a perspective top view of the embodiment of FIG. 17 in a third configuration;
FIG. 23 is a perspective bottom view of the embodiment of FIG. 22;
FIG. 24 is a perspective side view of the embodiment of FIG. 22;
FIG. 25 is a front view of an embodiment of the present invention in a third example use environment;
FIG. 26 is a schematic side view of the embodiment of FIG. 25;
FIG. 27 is a front view of the embodiment of FIG. 25 in a second configuration;
FIGS. 28A-28B depict an example use sequence of the second configuration of FIG. 27;
FIG. 29 is a schematic side view of the embodiment of FIG. 25 in a third configuration and in a fourth example use environment
FIG. 30 is a perspective top view of the embodiment of FIG. 17 in a fourth configuration;
FIG. 31 is a perspective bottom view of the embodiment of FIG. 30;
FIG. 32 is a perspective top view of the embodiment of FIG. 17 in a fifth configuration;
FIG. 33 is a perspective bottom view of the embodiment of FIG. 32;
FIG. 34 is a perspective top view of the embodiment of FIG. 17 in a sixth configuration;
FIG. 35 is a perspective bottom view of the embodiment of FIG. 34;
FIG. 36 is a perspective top view of the embodiment of FIG. 17 in a seventh configuration;
FIG. 37 is a perspective bottom view of the embodiment of FIG. 36;
FIG. 38 is a perspective top view of the embodiment of FIG. 17 in a eighth configuration; and
FIG. 39 is a perspective bottom view of the embodiment of FIG. 38.



DESCRIPTION OF EMBODIMENTS
The patient tissue is shown and described herein at least as a scapula or a pelvis and the prosthetic implant component is shown and described herein at least as a glenoid prosthetic shoulder component or an acetabular prosthetic hip component, but the patient tissue and corresponding prosthetic implant component could be any desired types such as, but not limited to, hip joints, shoulder joints, knee joints, ankle joints, phalangeal joints, metatarsal joints, spinal structures, long bones (e.g., fracture sites), or any other suitable patient tissue use environment for the present invention.
FIG. 1 depicts a portion of the external surface of a (left) scapula 100, viewed from the anterior direction toward the posterior direction, which is an example of a possible patient tissue use environment for the described systems, apparatuses, and methods. The humerus (not shown) of a patient attaches to the scapula 100 at the glenoid fossa 102 to form the ball-and-socket shoulder joint.
The glenoid fossa 102 is shown in greater detail in FIG. 2, a view taken orthogonally from FIG. 1. The term “lateral” is used herein to refer to a direction which, in FIG. 2, lies substantially within the plane of the drawing as shown by directional arrow 104 and includes all of the superior, inferior, anterior, and posterior directions. The term “longitudinal” is used herein to refer to a direction defined perpendicular to the plane created by directional arrow 104, with the longitudinal direction being substantially into and out of the plane of the drawing in FIG. 2 and representing the proximal (toward the medial plane of the body) and distal (out from the body) directions, respectively.
FIG. 3 is a partial perspective view of the scapula 100, with particular emphasis on the glenoid fossa 102. For the sake of discussion, the glenoid fossa 102 itself is referred to herein as a primary patient tissue area 108. That is, the primary patient tissue area 108 is a portion which directly receives an implant and/or is otherwise directly affected by a surgical procedure. In contrast, a secondary patient tissue area 110 is one which does not receive an implant and/or is not directly affected by a surgical procedure. In FIG. 3, the secondary patient tissue area 110 borders the primary patient tissue area 108 and is anatomically differentiated from the primary patient tissue area (i.e., the glenoid fossa 102) by the glenoid rim, indicated approximately by differentiation line 312. Here, the differentiation line 312 generally indicates an arbitrary (i.e., “depending on individual discretion”) position along the continuous transition between the glenoid fossa 102 and the supporting structures (e.g., the glenoid rim, the glenoid neck, the base of the coracoid, and/or the glenoid wall). However, regardless of the precise position of the differentiation line 312 for a particular application of the present invention, one of ordinary skill in the art should be able to distinguish between a primary patient tissue area 108 (one which is directly affected by a surgical procedure) and a secondary patient tissue area 110 (one which is incidentally affected by a surgical procedure, if at all) for the purposes of the present invention.
A distinction is made herein between the primary and secondary patient tissue areas 108 and 110 because the present invention relates to the association of at least one landmark with at least one of the primary and secondary patient tissue areas. The term “landmark” is used herein to indicate any guiding aid which serves as a detectable indicator of a particular position on a “marked” substrate (here, the patient tissue). The landmarks discussed with respect to the present invention are presumed to be affixed or otherwise rigidly associated with a particular patient tissue so that a user can confidently maintain a sense of physical and/or visual orientation within the operative field. Suitable landmarks may include, but are not limited to, visual “written” marks (e.g., a thin layer of a substance left behind after contact with a crayon, surgical pen, or the like), other written marks outside the visual spectrum (e.g., a UV-fluorescent paint), guide pins, fasteners (e.g., screws, nails, staples, or the like), radioactive tags, bovie cautery burn marks, metallic or nonmetallic devices attached to the desired landmark site (e.g., a rivet, tack, or the like), or even modifications of the patient tissue itself (e.g., notches, inscribed lines, drill holes, or the like). Depiction of one type of landmark 114 in the Figures herein merely serves as an example and does not preclude the use of a different type of landmark, even in a similar use environment to those depicted, for a particular application of the present invention.
Three landmarks 114a, 114b, and 114c are shown in FIG. 3 as having been associated with the primary and secondary patient tissue areas 108 and 110. Landmarks 114a and 114b are three-dimensional pins which have been inserted into the primary and secondary patient tissue areas 108 and 110, respectively. Landmark 114c is a visible two-dimensional cross mark on the secondary patient tissue area 110.
Any landmark 114, regardless of type, will be located at a predetermined marking location with respect to the primary and/or secondary patient tissue areas 108 and 110. A three-dimensional landmark, like the marking pins shown as landmarks 114a and 114b in FIG. 3, may also have a predetermined marking trajectory which, like the marking location, holds some significance for the user. For example, landmarks 114a and 114b do not have parallel trajectories as depicted in FIG. 3. While the marking trajectory of a three-dimensional landmark 114 (i.e., one protruding noticeably from the patient tissue surface) might have no significance, the following discussion presumes, for ease of reference, that the marking trajectory of the three-dimensional landmark is intentionally provided and is held substantively constant during the tenure of the landmark at the marking location.
It is contemplated that a landmark 114 will normally be rigidly affixed to a particular marking location on the primary or secondary patient tissue area 108 or 110 in order to serve as a reliable lodestar for the user. However, in certain situations, the marking location of the landmark 114 may move (as seen from an outside point of reference) after placement, of its own accord, by action of a user, or by action of the substrate patient tissue, and these situations do not pass out of the domain of the present invention merely by virtue of such intentional or unintentional post-placement landmark motion.
The marking location and marking trajectory of each landmark 114 are predetermined by a user before the landmark is associated with the patient tissue. This predetermination may occur intraoperatively, as the user is able to directly see the condition of the surgical site. However, it is contemplated that a predetermination of the desired marking location and desired marking trajectory for each landmark 114 could be accomplished preoperatively, with reference to preoperative imaging of the patient tissue. For example, a system similar to that of co-pending U.S. patent application Ser. No. 13/282,550, filed Oct. 27, 2011, titled “System of Preoperative Planning and Provision of Patient-Specific Surgical Aids” and claiming priority to U.S. Provisional Patent Application No. 61/408,392, filed Oct. 29, 2010 and titled “System of Preoperative Planning and Provision of Patient-Specific Surgical Aids”, the entire contents of both of which are incorporated herein by reference, or any suitable preoperative planning system could be used. In this manner, a user can create a patient tissue model for observation, manipulation, rehearsal, or any other pre-operative tasks.
The term “model” is used herein to indicate a replica or copy of a physical item, at any relative scale and represented in any medium, physical or virtual. The patient tissue model may be a total or partial model of a subject patient tissue, and may be created in any suitable manner. For example, and as presumed in the below description, the patient tissue model may be based upon computer tomography (“CT”) data imported into a computer aided drafting (“CAD”) system. Additionally or alternatively, the patient tissue model may be based upon digital or analog radiography, magnetic resonance imaging, or any other suitable imaging means. The patient tissue model will generally be displayed for the user to review and manipulate preoperatively, such as through the use of a computer or other graphical workstation interface.
Once the user is satisfied with her preoperative planning tasks, virtual landmarks may be virtually placed on the patient tissue model. In order to transfer those virtual landmarks to the physical world for intra-operative use, a patient-specific apparatus (shown in FIG. 4 as a guide 416) may be at least partially customized responsive to preoperative imaging of the patient tissue. Accordingly, at least a part of the guide 416 is a patient-specific, single-use, bespoke component suited only for use at the indicated surgical site, though one of ordinary skill in the art could create a guide (not shown) which uses a patient-specific “disposable” structure connected to a stock, generic “reusable” carrier.
The patient's name, identification number, surgeon's name, and/or any other desired identifier may be molded into, printed on, attached to, or otherwise associated with the guide 416 in a legible manner. The guide 416 may be made by any suitable method such as, but not limited to, selective laser sintering (“SLS”), fused deposition modeling (“FDM”), stereolithography (“SLA”), laminated object manufacturing (“LOM”), electron beam melting (“EBM”), 3-dimensional printing (“3DP”), contour milling, computer numeric control (“CNC”), other rapid prototyping methods, or any other desired manufacturing process.
The guide 416 assists the user by associating a plurality of landmarks 114 with patient tissue, each landmark being associated with the patient tissue in at least one of a predetermined marking location and a predetermined marking trajectory. As depicted in FIGS. 4-7, a base 418 may have a lower base surface 520 contoured to mate with both the primary and secondary patient tissue areas 108 and 110 in a preselected relative orientation. The term “mate” is used herein to indicate a relationship in which the contours of two structures are at least partially matched or coordinated in at least two dimensions. In the described mating relationship depicted in FIGS. 4-7 as an example of the present invention, the lower base surface 520 mates or nests into contact with the surfaces of both the primary and secondary patient tissue areas 108 and 110 to provide the guide 416 with at least one of location and stabilization assistance with respect to the patient tissue.
The lower base surface 520 is spaced apart from an upper base surface 422 by a base body 424. A plurality of base apertures 526 extend between the upper and lower base surfaces 422 and 520 through the base body 424. The base apertures 526 are shown here as extending substantially longitudinally through the base body 424, but may have any desired orientation with respect to the base 418.
A plurality of guiding bosses 428 may protrude from the base 418 in certain configurations of the present invention. As shown in the Figures, the guiding bosses 428 protrude substantially longitudinally outward from the upper base surface 422, but the guiding bosses may have any desired orientation with respect to the base 418. Each guiding boss 428 has a guiding bore 428 extending therethrough. Each guiding bore 428 extends collinearly with a corresponding base aperture 526 to permit insertion of a landmark 114 through the guide 416. The term “insertion of a landmark through” is intended to encompass both a physical feeding of a three-dimensional landmark itself through the indicated structure for affixation to the underlying patient tissue (e.g., by penetration), as well as the temporary introduction of a marking device (e.g., a pen, bovie, rasp, other marking actuator or substance dispenser, or the like) through the indicated structure for affixation of a two-dimensional landmark 114 directly onto the patient tissue.
Each guiding bore 430 and corresponding base aperture 526 cooperatively defines at least one of the predetermined marking location and the predetermined marking trajectory (shown in FIG. 5 by trajectory lines 532) for an associated landmark 114. In the embodiment shown in FIGS. 4-7, at least one landmark 114 is guided by the guide 416 into engagement with a marking location in the primary patient tissue area 108 (via the rightmost guiding bore 430 in the orientation of FIG. 5) and at least one landmark is guided by the guide into engagement with a marking location in the secondary patient tissue area 110 (via the leftmost guiding bore 430 in the orientation of FIG. 5).
FIG. 6 depicts the guide 416 of FIG. 4 in a slightly different orientation in space, such that the contour of the lower base surface 520 may be seen in more detail. In the orientation of FIG. 6, the leftmost portion of the lower base surface 520 appears relatively broad and flat and is configured to mate with the surface of the glenoid fossa 102 (i.e., the primary patient tissue area 108 here). The differentiation line 312 from FIG. 3 is shown “ghosted” into FIG. 6 and extends somewhat into and out of the plane of the page due to the camber of the depiction in FIG. 6. With the addition of the differentiation line 312, it can be clearly seen that the rightmost portion of the lower base surface 520 does not mate with the primary patient tissue area 108, but instead dips sharply downward relative to the rest of the lower base surface to mate with the bordering secondary patient tissue area 110. Particularly when there is a “lip” or “rim” between the primary and secondary patient tissue areas 108 and 110, such as with the glenoid fossa 102, the ability of the lower base surface 520 to concurrently nest with both of these patient tissue areas may be helpful to the user in quickly and securely nestling the guide 416 down into the desired mating relationship with the patient tissue.
In FIG. 7, the upper base surface 422 and protruding guiding bosses 428 can be seen in detail. Particularly when a marking trajectory (such as that shown by trajectory lines 532) is defined by the base aperture 526, with or without the assistance of a guiding bore 430, it may be helpful for the guiding bosses 428 to provide a longer guiding structure for the inserted landmark 114. In other words, an elongate landmark 114 might precess within a relatively short base aperture 526, but the presence of the guiding boss 428 can support and stabilize insertion of the landmark to better guide the landmark along the predetermined marking trajectory.
FIGS. 8-10 depict the generation of a suitable design for an example guide 416 during a preoperative planning procedure. FIGS. 8-10 are example user views of a computer program for implementing a method using the present invention, with a perspective view on the left side of each Figure and coronal, sagittal (looking distally from underneath the perspective view, as shown), and transverse views, respectively, from top to bottom on the right side of each Figure.
In FIG. 8, a stock glenoid implant 834 is shown associated with a glenoid fossa 102 of a patient's scapula 100, embodied in a model produced using preoperative imaging. The glenoid implant 834 may be virtually placed as desired on the scapula 100 by the user, or may be automatically placed by the computer program with or without a final check/adjustment by the user. The glenoid implant 834 appears to overlap with the glenoid fossa 102 in particularly the coronal (top right) and transverse (bottom right) views of FIG. 8, but this overlap (when present) is acceptable at the planning stage of FIG. 8 since the physical glenoid fossa 102 will be prepared via machining or other alteration(s) as desired during installation of the physical glenoid implant 834 at the surgical site, and this overlap will be corrected by removal of the interfering patient tissue. In fact, relatively precisely placed landmarks 114 are useful during many surgeries because the site preparation procedure commonly erodes, moves, or destroys natural landmarks which otherwise would help the user with placement or orientation during the surgical procedure.
Implant stem 836, visible in cross-section in the coronal and transverse portions of FIG. 8, is a tubular anchoring extension from the underside of the glenoid implant 834 which is inserted into the patient tissue of the glenoid fossa 102 during use. One consideration that a user may have during placement of the glenoid implant 834 using the computer program shown in FIGS. 8-10 is being able to locate the implant stem 836 in a solid portion of the patient's scapula 100. Another, similar consideration is the location of screws or other fasteners (not shown) which are commonly used to secure the glenoid implant 834 to the glenoid fossa 102. The user will want to ensure that the proper locations and trajectories are chosen for affixation of the selected fasteners into relatively robust areas of the patient's scapula 100. Once the glenoid implant 834 (including the implant stem 836 and the associated fasteners) has been virtually placed as desired into a final installation position, the user can decide where to place one or more landmarks 114, using the guide 416 and relatively early in the surgical process, to facilitate later tasks during the surgery. For example, the user of the FIG. 8 example may wish to place a guide pin as a landmark 114 at each of the marking locations 838 indicated by cross marks. As shown in FIG. 8, one marking location 838a is placed in the primary patient tissue area 108 and another marking location 838b is placed in the secondary patient tissue area 110. For certain surgical procedures, both of these locations may be marked as desired for bone preparation and final implant positioning. Landmarks 114 may be placed before the patient tissue is altered or modified, with the marking locations 838 corresponding to each landmark being specified during the preoperative surgical planning and/or simulation, or in any other suitable manner.
For example, a guide pin is displayed as a three-dimensional landmark 114 at the marking location 838a spaced apart from the glenoid implant 834 over the image of scapula 100 in FIG. 8, while an aperture or cavity formed in the scapula is shown as a two-dimensional landmark 838b (i.e., represented by a cross mark when seen from above or below) corresponding to a central portion of the glenoid implant in FIG. 8. In fact, the “negative” aperture-type landmark 838b of FIG. 8 is configured to receive a device shaft implant stem 836 of the glenoid implant 834, which helps to locate and stabilize the glenoid implant with respect to the scapula 100. One of ordinary skill in the art would readily be able to instead provide a “positive” pin- or shaft-type landmark (not shown) protruding from the scapula 100 and adapted to be received in a cavity (not shown) of another type of device, in an axle-type manner.
Optionally, the marking locations 838 may be chosen to comport to common landmark 114 placements to facilitate use of standard tools (not shown) with the guide 418. For example, two marking locations 838 may be provided to indicate a line bisecting the scapula 100 for that patient so that the user has a standardized reference line. In this example, then, generic surgical tools which use the scapula-bisecting line as a landmark in every patient will encounter a patient tissue which has been standardized, through use of personalized landmark 114 placements, to meet a universal expectation of the user. In other words, and more generally, the marking location 838 choices can be set for a particular patient tissue in order to compensate for any peculiarities of that patient tissue and accordingly provide the user with a surgical site that may be addressed using stock (i.e., not patient-specific) tools and/or techniques. This type of “universal registration” may be especially helpful in automation-assisted surgeries.
In FIG. 9, a user view of the computer program shows a guide blank 940 superimposed on the scapula 100. Since the guide 418 will be used to place the landmark(s) 114 before the surgical site is altered, the lower base surface 422 should be designed as a mirror image of the surface of the glenoid fossa 102, to mate with the primary and secondary patient tissue areas 108 and 110 as desired. The resolution of the preoperative imaging scans and the available precision of the chosen manufacturing method for the guide 416 will determine how precisely this mating is accomplished. As is apparent in FIG. 9, the guide blank 940 contacts and mates with both the primary and secondary tissue areas 108 and 110. The marking locations 838a and 838b identified in the view of FIG. 8 are represented as a small circle and a cross mark, respectively, on the guide blank 940 in FIG. 9.
Turning to FIG. 10, the areas of the guide blank 940 which overlap with the patient tissue of the scapula 100 have been removed by the computer program, generating the complex contour of the lower base surface 520 (most apparent in the coronal view). Additionally, base apertures 526 and corresponding guiding bosses 428 with guiding bores 430 have been placed at the desired marking locations 838, the base apertures and guiding bores being collinear to cooperatively define desired marking trajectory lines 532. Once the preoperative planning has been accomplished, through user input and/or automatic programming, the design of the guide 416 is complete and the guide can be manufactured and prepared for use (e.g., mechanically or chemically cleaned, cured, sterilized, or the like) using any suitable process(es).
FIGS. 11-15 depict various options for configurations of the guide 416. These different configurations, along with other (non-depicted) configurations, of guides 416 can be selected/designed and used by one of ordinary skill in the art to provide desired landmark-placement properties for different patient tissues. Structures of FIGS. 11-15 that are the same as or similar to those described with reference to FIGS. 4-10 have the same reference numbers. As with all alternate configurations shown and described herein, description of common elements and operation similar to those in previously described configurations will be omitted, for clarity. In the second configuration, shown in FIGS. 11-12, the guide 416 is relatively large compared to that of FIGS. 4-10 (although the Figures herein are not drawn to scale). As can be seen in the comparative views of FIGS. 10 and 12, the guide 416 of the second configuration (shown in situ in FIG. 12) covers more of the glenoid fossa 102 than does the guide 416 of the first configuration (shown in situ in FIG. 10). Additionally, the leftmost base aperture 526 and guiding bore 430 (as seen in the orientation of FIG. 12) is located substantially in an anterior portion of the secondary patient tissue area 110 for the second configuration, while the corresponding structures in the first configuration are located substantially more superiorly within the secondary patient tissue area 110.
The third configuration of the guide 416, shown in FIG. 13, seems similar to that of FIGS. 11-12, with the addition of at least one marking notch 1342. The marking notch(es) 1342 may be useful for guiding contact with the patient tissue for placing a two-dimensional (e.g., via a pen, bovie, crayon, or other marking device) or three-dimensional landmark 114 at a desired marking location 838, particularly if achieving a precise marking trajectory is not important.
FIG. 14 shows a fourth configuration of the guide 416 which includes features from several of the previously defined configurations. The guide 416 of FIG. 14 has a blockier shape than that of FIG. 13, which may provide efficiencies in design and/or fabrication. That is, the blockier shape of the fourth configuration guide 416 may be better suited to a design scheme involving the provision of a generic guide blank 940. In contrast, the contoured upper base surface 422 exhibited by the third configuration guide 416 requires more extensive smoothing and shaping operations (during the virtual modeling of the computer program and/or during physical manufacture), particularly if the base body 424 is configured to have a substantially uniform thickness by some degree of mirroring of the lower base surface 520 (dictated by the glenoid fossa 102) with the contour of the upper base surface 422. In the fourth configuration of FIG. 14, the marking notch 1342 of the guide 416 is somewhat rounded and may be operative to assist with placement of a three-dimensional landmark 114, such as a guide pin, at the marking location 838, optionally with some degree of imposed marking trajectory.
A fifth configuration of the guide 416 is shown in FIG. 15. The guide 416 shown in FIG. 15 is similar to that shown in FIG. 16, with a guiding boss 428 in place of the marking notch 1342, and with the addition of a handling boss 1544. The handling boss 1544 protrudes from the base 418 and is configured for manipulation by the user to at least partially control a position of the guide 416. Sometimes the available maneuvering space in a surgical field is relatively restricted, and it may be useful for a forceps, socket driver (perhaps with a frictional fit or other feature to accept the handling boss 1544), Kocher tool, hemostat, or other user-manipulated handling tool (not shown) to selectively interact with the handling boss to hold the guide 416 steady and/or to move the guide 416 to a desired position. One or more features, such as indents, apertures, cavities, lugs, undercuts, or any other suitable structures could be provided to the handling boss 1544 to facilitate gripping of the guide 416 by any handling tool, in general, and/or by a particular handling tool (perhaps one chosen in conjunction with the chosen glenoid implant 834). Optionally, the handling boss 1544 may also be a guiding boss 428. However, in some situations it will be desirable for each of the guiding bosses 428 to be accessible for landmark 114 placement at the same time that a handling tool is engaged with the handling boss 1544, so the handling boss could be a separate structure in those situations.
Regardless of the specific configuration chosen for a particular patient, the guide 416 will generally be used relatively early in the surgical procedure. The guide 416 has a base 418 at least partially customized (e.g., custom-manufactured and/or custom-configured) responsive to preoperative imagining of the patient tissue. The base 418 of the guide 416 is mated with at least one of the primary and secondary patient tissue areas 108 and 110 in a preselected relative orientation. When the base 418 is mated with both the primary and secondary patient tissue areas 108 and 110, the mating may be concurrent for both those patient tissue areas.
At least one landmark 114 is guided by the guide 416 to a marking location 838 in the primary patient tissue area 108 and fixed to the primary patient tissue area 108 in at least one of a predetermined marking location 838 and an predetermined marking trajectory, such as by passing of the landmark 114 along a marking notch 1342 or through a base aperture 526 (optionally with the assistance of a guiding bore 430). Optionally, at least one additional landmark 114 may be guided by the guide 416 to a marking location 838 in the secondary patient tissue area 110 and fixed to the secondary patient tissue area 110 in at least one of a predetermined marking location 838 and an predetermined marking trajectory, such as by passing of the additional landmark along a marking notch 1342 or through a base aperture 526 (optionally with the assistance of a guiding bore 430).
Once the desired number of landmarks 114 are affixed to the primary and/or secondary patient tissue areas 108 and 110, the guide 416 is removed from the surgical site in any suitable manner, optionally with the assistance of a handling boss 1544. When at least one landmark 114 is a guide pin or other elongate three-dimensional structure, the guide pin may deflect, if needed, to allow the guide 416 to be lifted longitudinally off the protruding end guide pin. Alternately, the guide 416 may include at least one frangible portion to allow substantially laterally-oriented removal of the guide 416 from around the guide pin. As another example, the guide 416 could include one or more slots (not shown) to allow removal of the guide by sliding the guide sideways away from the guide pin.
Regardless of the manner in which the guide 416 is removed from the primary and secondary patient tissue areas 108 and 110, the landmark(s) 114 remain behind and the surgical site attains a configuration akin to that shown in FIG. 3. The user can then proceed with the surgical procedure with confidence that the landmark(s) 114 are substantially located as configured in the preoperative plan. The patient tissue at the primary patient tissue area 108 can be altered and the landmark(s) 114 that remain as placed using the guide 416 can be used to orient such alteration or for any other surgical task. For example, a prosthetic implant (such as the glenoid implant 834, when the patient tissue is a scapula 100) may be placed, optionally with the assistance of another patient-specific guide, such as that disclosed in co-pending U.S. patent application Ser. No. 13/282,495, filed Oct. 27, 2011, titled “System and Method for Assisting with Attachment of a Stock Implant to a Patient Tissue” and claiming priority to U.S. Provisional Patent Application No. 61/408,324, filed Oct. 29, 2010 and titled “System and Method for Assisting with Attachment of a Stock Implant to a Patient Tissue”, the entire contents of both of which are incorporated herein by reference.
FIGS. 16-24 depict a guide 416′ according to certain aspects of a second embodiment of the present invention. The guide 416′ of FIGS. 16-24 is similar to the guide 416 of FIGS. 1-15 and therefore, structures of FIGS. 16-24 that are the same as or similar to those described with reference to FIGS. 1-15 have the same reference numbers with the addition of a “prime” mark. Description of common elements and operation similar to those in the previously described first embodiment will not be repeated with respect to the second embodiment.
FIG. 16 depicts an example use environment for the guide 416′ of the second embodiment. Directional arrow 104′ indicates the superior/inferior and anterior/posterior directions. The body of ischium, body of ilium, and body of pubis are shown generally at 1646, 1648, and 1650, respectively. The acetabulum 1652 (here, the primary patient tissue area 108′), which is formed in part by these three bodies 1646, 1648, and 1650, has a recessed acetabular fossa 1654 and is surrounded by an acetabular margin 1656 (here, the secondary patient tissue area 110′, shown approximately in FIG. 16 as being outside the dashed differentiation line 312′).
In accordance with the present invention, FIG. 17 depicts a guide 416′ including a base 418′, a stem 1758, and at least one spacing arm 1760. The base 418′ has a lower base surface 520′ (shown partially in phantom line in FIG. 17) spaced apart from an upper base surface 422′ by a base body 424′. The lower base surface 520′ is contoured to mate with the acetabulum 1652 in a preselected relative orientation thereto. The base 418′ may include a base guide aperture 1762 configured to guide placement of a landmark 114′ inserted at least partially therethrough in at least one of a predetermined marking location and a predetermined marking trajectory, the marking location being in the primary patient tissue area 108′.
The stem 1758 has longitudinally separated first and second stem ends 1764 and 1766, respectively. The first stem end 1764 is attached directly to the base 418′, either permanently or removably. The stem 1758 extends longitudinally upward from the base 418′ (substantially out of the plane of the paper, in FIG. 17).
At least one spacing arm 1760 (two shown) is attached directly to the second stem end 1766, either permanently or removably. Each spacing arm 1760 is longitudinally spaced from the base 418′ and has an arm guide aperture 1768 laterally spaced from the stem 1758. The arm guide aperture 1768 is configured to guide placement of a landmark (not shown in this Figure) inserted at least partially therethrough at a predetermined landmark trajectory (represented by trajectory line 532′). The spacing arm(s) 1760 are shown in the Figures as extending orthogonally from the stem 1758 at the second stem end 1766, in order to place landmarks 114′ in the acetabular margin 1656 (the secondary patient tissue area 110′) as will be discussed below. The spacing arm(s) 1760 could extend at any suitable angle or position from the stem 1758, or could even be smoothly formed as a single integral piece with the stem. In the latter event, the second stem end 1766 may not be clearly delineated from the spacing arm(s) 1760.
The stem 1758 and spacing arm(s) 1760 could have any of a myriad of configurations, depending upon the application of the present invention. A spacing arm 1760 is used herein to indicate any structure which is located at some distance from base 418′ contacting a primary patient tissue area 108′, and the spacing arm includes structure which can guide a landmark 114′ to a secondary patient tissue area 110′. A stem 1758 is used herein to indicate any structure which extends between and connects the base 418′ and at least one spacing arm 1760.
The guide 416′ may be at least partially customized responsive to preoperative imaging of the patient tissue. For example, the lower base surface 520′ of the base 418′ could be at least partially configured through the use of computer tomography (“CT”) data of the patient tissue to have a longitudinally downward-protruding portion corresponding to the acetabular fossa 1656. Additionally or alternatively, the lower base surface 520′ could be at least partially configured through use of patient scans including digital or analog radiography, magnetic resonance imaging, or any other suitable imaging means. The patient tissue preoperative images are optionally displayed for review and manipulation before/during configuration of the lower base surface 520′, such as through the use of a computer or other graphical workstation interface described above with reference to the first embodiment of the present invention. The configuration of the lower base surface 520′ is described herein as being performed using three-dimensional images; however, one or more two-dimensional depictions of the patient tissue may also or instead be consulted during configuration of the lower base surface 520′ or any other preoperatively configured structure herein.
The lower base surface 520′ is configured to mate with a primary patient tissue surface 108′, as will be discussed below. In the described mating relationship, the lower base surface 520′ mates or nests into contact with the surface of the acetabulum 1652 to provide the base 418′ with at least one of location and stabilization assistance with respect to the patient tissue. Though the lower base surface 520′ is shown herein as covering a substantial portion of the acetabulum 1652, the lower base surface 520′ may contact any suitable portion of the primary patient tissue area 108′ sufficient to stabilize the guide 416′ in a desired manner.
FIGS. 19-21 depict a guide 416′ which is a second configuration of the embodiment of the present invention in the second embodiment of FIG. 17. The guide 416′ of FIGS. 19-21 mainly differs from the guide 416′ of FIG. 17 in the provision of at least one outrigger 1770 as an extension of the base 418′. The underside (tissue-contacting) surface of each outrigger 1770 forms a portion of the lower base surface 520′ and is accordingly contoured to mate with a portion of the acetabulum 1652′ (the primary patient tissue surface 108′) and the surrounding secondary patient tissue surface 110′. For example, and as shown in the bottom view of FIG. 20, the outrigger(s) 1770 may extend laterally beyond the remaining acetabular-contacting portion of the base 418′. The outrigger(s) 1770 shown in FIGS. 19-21 may contact, or even hook over, the acetabular margin 1656′ to assist with positioning and/or stabilizing of the guide 416′ as shown in the cross-sectional side view of FIG. 21. The side view of FIG. 19 and the bottom view of FIG. 20 also clearly show a protrusion 1972 formed by the contour of the lower base surface 520′ and shaped to mate with the acetabular fossa 1654 (shown in FIG. 16). Because each patient's bone structure is unique, at least a portion of the guide 416′ (e.g., the outriggers 1770 and lower base surface 520′) is customized responsive to preoperative imaging of the patient tissue.
FIG. 21 also shows an orthopedic guidewire 2174 acting as a landmark. One example of a suitable guidewire 2174 is disclosed in co-pending U.S. patent application Ser. No. 13/178,324, filed Jul. 7, 2011, titled “Method and Apparatus for Providing a Relative Location Indication During a Surgical Procedure” and claiming priority to U.S. Provisional Patent Application Ser. No. 61/362,722, filed Jul. 9, 2010, and titled “Method and Apparatus for Providing a Relative Location Indication During a Surgical Procedure”, the contents of both of which are hereby incorporated by reference in their entirety. Additionally, FIG. 21 shows a pair of conventionally-configured guide pins acting as three-dimensional landmarks 114′, though any suitable number, combination, and/or types of two- or three-dimensional landmarks 114′ and/or guidewires may be provided for a particular use environment of the present invention, and may be associated with either or both of the base guide aperture(s) 1762′ and the arm guide aperture(s) 1768′.
At least a portion of the guidewire 2174 is insertable through the base guide aperture 1762′ and into the underlying acetabulum 1652′ when the guide 416′ is mated with the patient tissue in the preselected relative orientation. Similarly, at least a portion of each of the landmarks 114′ is insertable through the arm guide aperture 1768′ and into the underlying second patient tissue area 110′, shown here as being located just beyond an acetabular margin 1656′, when the guide 416′ is mated with the patient tissue in the preselected relative orientation.
A distal end 2176 of the landmark 114′ or guidewire 2174 is configured to remain inserted into the patient tissue when the guide 416′ is removed from the patient tissue. It is contemplated that the base guide aperture 1762′ and/or arm guide aperture 1768′ will be sized to pass over the respective landmark 114′ or guidewire 2174, leaving these guiding landmark structures in place such as in the configuration shown in FIG. 18. The landmark(s) 114′ and/or guidewire(s) 2174 may remain in place for as long as the user desires, though normally will be removed from the patient's body before the surgical procedure is concluded. The landmark(s) 114′ and/or guidewire(s) 2174 also may be used for any reason in conjunction with any type or number of processes, during or after the surgical procedure in which they were installed. A common guiding function for a landmark 114′ or guidewire 2174 is to guide the positioning of another structure, either directly (via contact) or indirectly (spaced apart from the guided structure).
FIGS. 22-24 depict a guide 416′ which is a third configuration of the second embodiment of the present invention and combines features of both the previous configurations of the second embodiment, as well as some features of the guide 416 of the first embodiment. The guide 416′ of FIGS. 22-24 has a very complex base structure with a bifurcated lower base surface 520′ which concurrently contacts at least a portion of a primary patient tissue area 108′ (i.e., contacts an acetabulum 1652 with the leftmost portion of the lower base surface, as shown in the orientation of FIG. 23) and at least a portion of a secondary patient tissue area 110′ (i.e., contacts an acetabular margin 1656 with the rightmost portion of the lower base surface, as shown in the orientation of FIG. 23). A plurality of guiding bosses 428′ are provided to the guide 416′ of FIGS. 22-24, including two guiding bosses located on an extended portion 2278 of the base body 424′ to place landmarks 114′ in the secondary patient tissue area 110′ and one guiding boss located on a central portion 2280 of the base body to place a landmark 114′ in the primary patient tissue area 108′.
The guiding boss 428′ located on the central portion 2280 of the base body 424′ is noticeably longer than the other guiding bosses, and may serve several functions for the guide 416′. The guiding boss 428′ located on the central portion 2280 of the base body 424′ may guide a landmark 1114 through a guiding bore 430′ thereof; may guide a rasp, drill, or other tissue modification tool (not shown) therethrough, optionally providing a “stop” function to limit insertion of the tissue modification tool into the underlying patient tissue; and/or may serve as a handling boss for user manipulation by hand and/or with a handling tool.
FIGS. 25-29 depict a guide 416′′ according to a third embodiment of the present invention. The guide 416′′ of FIGS. 25-29 is similar to the guide 416 of FIGS. 1-15 and therefore, structures of FIGS. 25-29 that are the same as or similar to those described with reference to FIGS. 1-15 have the same reference numbers with the addition of a double “prime” mark. Description of common elements and operation similar to those in the previously described first and second embodiments will not be repeated with respect to the second embodiment.
The guide 416′′ of the third embodiment of the present invention may be used both for associating a plurality of landmarks 114′′ with a patient tissue in at least one of a predetermined marking location and a predetermined marking trajectory, and for guiding the removal of a predetermined amount of resection patient tissue and rearrangement of a remaining patient tissue, as will be described. One example of a potential use environment for the guide 416′′ of the third embodiment is in conjunction with a surgical procedure to correct a congenital or acquired orthopedic malunion.
FIGS. 25-26 depict a guide 416′′ in a first configuration in front and side views, respectively, in a use environment of a patient tissue forming at least a portion of a patient tissue such as, but not limited to, a femur, humerus, radius, ulna, tibia, fibula, metatarsal, phalange, another type of long bone shaft, a flat bone such as the mandible, a facial bone, a scapula body, a bone of the wrist or ankle, or any other patient tissue. In these Figures, the primary patient tissue area 108′′ is a resection patient tissue 108′′ (shaded in FIG. 26) and the secondary patient tissue area 110′′ is a remaining patient tissue 110′′. The guide 416′′ of FIGS. 25-26 is configured to contact the resection patient tissue 108′′ and the remaining patient tissue 110′′ and to guide surgical contact with the patient tissue.
The guide 416′′ of FIGS. 25-26 has a base 418′′ having a lower base surface 520′′ contoured to mate with both the resection and remaining patient tissues 108′′ and 110′′ in a preselected relative orientation. The lower base surface 520′′ is spaced apart from an upper base surface 422′′ by a base body 424′′, as shown in FIG. 26.
As shown in FIGS. 25-26, at least one base aperture 526′′ (two shown here) guides a landmark 114′′ into contact with the underlying tissue surface in at least one of a predetermined marking location 838′′ and a predetermined marking trajectory. A plurality of first guide cutting guide apertures 2582 extend between the upper and lower base surfaces 422′′ and 520′′ through the base body 424′′ to permit penetration of at least one cutting tool (shown schematically at 2584) through the guide 416′′. The cutting guide apertures 2582 each define at least one cutting plane location and cutting plane orientation for the cutting tool 2584 to make at least one resection cut into the patient tissue.
More specifically, the guide 416′′ is configured to cut the resection patient tissue 108′′ for removal from the remaining patient tissue 110′′. The resection patient tissue 108′′ is shaded in the Figures, and the cutting plane locations and orientations are chosen to correspond to the borders of the resection patient tissue. Because the resection patient tissue 108′′ in the Figures is located intermediate two areas of remaining patient tissue 110′′, at least two cutting plane locations and orientations are needed to excise the resection patient tissue 108′′. If there were no remaining patient tissue 110′′ to one side (e.g., the topmost side in the orientation of FIG. 26), only one cutting plane location and orientation would be needed to sever the resection patient tissue 108′′. However, the latter situation would not be a true case of correction of a malunion, but merely an amputation. A patient-specific guide 416′′ could be produced and used for an amputation if desired. However, though not excluding an amputation situation from application of a guide 416′′, this description presumes for ease of discussion that at least two cuts will be made to excise an area of resection patient tissue 108′′ from a surrounding area of remaining patient tissue 110′′.
Optionally, and as shown in FIG. 26, at least one guiding boss 428′′ may protrude from the upper base surface 422′′ in association with at least one of the base apertures 526′′ and the cutting guide apertures 2582, as shown in FIG. 26. The guiding bosses 428′′ shown in FIG. 26 may be helpful in avoiding precession of the cutting tools 2584 and thereby assist in guiding the cutting tools to make accurate cuts according to the preoperative plan embodied in the guide 416′′.
Once the resection patient tissue 108′′ has been cut and removed from the remaining patient tissue 110′′, the remaining patient tissue can be rearranged to correct two dimensions of deformity. From the deformed position of FIG. 26, therefore, the remaining patient tissue 110′′ areas can be collapsed together after removal of the shaded resection patient tissue 108′′ for correction in both the proximal-distal and superior-inferior dimensions. Accordingly, the patient tissue shown in FIG. 27 is composed entirely of remaining patient tissue and is substantially cylindrical along a superior-inferior axis 2786.
If there still remains a third degree of deformity, such as rotation about the superior-inferior axis 2786, to be corrected, then an optional guide 416′′ having a second configuration may be provided as shown in FIGS. 27-28A, the guide 416′′ of the second configuration being configured to guide surgical contact with the remaining patient tissue 110′′ after removal of the resection patient tissue 108′′. The guide 416′′ has a lower base surface 520′′ contoured to mate with the remaining patient tissue 110′′ in a preselected relative orientation after removal of the resection patient tissue 108′′. A plurality of base apertures 526′′ permit insertion of at least one landmark (two shown here, at 114a′′ and 114b′′) through the guide 416′′, the inserted landmarks either being extant at the surgical site before the guide of the second configuration is introduced or being inserted with the assistance of the guide of the second configuration.
At least one of the base apertures 526′′ of the guide 416′′ of the second configuration defines at least one of the predetermined marking location and the predetermined marking trajectory for a landmark 114a′′, 114b′′. For example, and as shown in the front view of FIG. 27 and the corresponding top view of FIG. 28A, the two landmarks 114a′′ and 114b′′ have substantially different marking locations and marking trajectories for their penetration into the remaining patient tissue 110′′. The landmarks 114a′′ and 114b′′ can therefore be used as indicators to aid in correction of the third degree of deformity.
Namely, one portion of the remaining patient tissue 110′ can be rotated about the superior-inferior axis 2786 (e.g., as indicated by rotation arrow 2888). Because the resection patient tissue 108′′ was fairly recently removed, an excision seam 2790 (visible in FIG. 27) separates the upper and lower (in the orientation of FIG. 27) portions 2792 and 2794, respectively of the remaining patient tissue 110′′ and permits relative rotation of those portions to correct the third degree of deformity.
Due to preoperative planning of the desired third-dimension rotation and embodiment of that planning in the guide 416′′ of FIGS. 27-28A, the landmarks 114a′′ and 114b′′ can be placed in the respective upper and lower portions 2792 and 2784 of the remaining patient tissue 110′′ at trajectories that help guide the rotation during the surgery. For example, and as shown in the sequence of FIGS. 28A-28B, the landmarks 114a′′ and 114b′′ can be placed relatively askew in the remaining patient tissue 110′′ at predetermined marking trajectories (as shown in FIG. 28A). Relative rotation of the upper and lower portions 2792 and 2784 about the superior-inferior axis 2786 then will reposition the landmarks 114a′′ and 114b′′ into a second orientation with respect to one another—such as the substantially parallel orientation shown in FIG. 28B—to indicate to the user that the desired third-dimension rotation has been achieved. This second orientation can be approximated by the user's own observation or can be measured or otherwise subjectively indicated.
It is contemplated that the landmarks 114a′′ and 114b′′ will each be substantially rigidly held within its respective upper and lower portions 2792 and 2784 of the remaining patient tissue 110′′, so as not to introduce an unwanted amount of inaccuracy into the rotation procedure. However, one of the upper and lower portions 2792 and 2794 might be configured to move with respect to the guide 416′′, with the respective landmark 114a′′ or 114b′′ precessing therein, during the rotation procedure.
Optionally, at least one base aperture 526 of the guide 416′′ of the second configuration may also or instead define a location and/or trajectory for insertion of a fastener (not shown) into the remaining patient tissue 110′′. Accordingly, the guide 416′′ may be configured to guide the placement of at least one fastener to retain the remaining patient tissue in a desired final arrangement.
The guide 416′′ of the second configuration might also or instead include at least one cutting guide aperture 2582 to permit penetration of a cutting tool 2584 through the guide 416′′. In this instance, the guide 416′′ would be configured to define at least one cutting plane location and orientation for a cutting tool 2584 to make at least one secondary cut into the remaining patient tissue 110′′, the secondary cut being configured to assist with the correction of the third dimension of deformity.
FIG. 29 depicts a third configuration of a guide 416′′ according to the third embodiment of the present invention. In FIG. 29, the guide 416′′ is configured to assist with correction of a malunion or other deformity in the head of a femur, humerus, tibia, phalange, mandible, scapula, or any other suitable bone or other patient tissue. The guide 416′′ of the third configuration 416′′ can be used similarly to the guides 416′′ of the first and second configurations.
FIGS. 30-39 depict a guide 416′ according to certain additional aspects of the second embodiment of the present invention. The guide 416′ of FIGS. 30-37 is similar to the guide 416 of FIGS. 1-15 and the guide 416′ of FIGS. 16-24 and therefore, structures of FIGS. 30-39 that are the same as or similar to those described with reference to FIGS. 1-15 and/or 16-24 have the same reference numbers with the addition of a “prime” mark. Description of common elements and operation similar to those in the previously described first embodiment will not be repeated with respect to the second embodiment.
FIGS. 30-39 depict fourth through eighth configurations of a guide 416′ of the second embodiment of the present invention and combines features of the previous three configurations of the second embodiment, as well as some features of the guide 416 of the first embodiment. The guides 416′ of FIGS. 30-39 each have a relatively complex base structure with a lower base surface 520′ which is spread across a plurality of extended portions 2278. The various segments of the lower base surface 520′ concurrently contact at least a portion of a primary patient tissue area 108′ and at least a portion of a secondary patient tissue area 110′. A plurality of guiding bosses 428′ are provided to the guides 416′ of FIGS. 30-39, including at least one “outboard” guiding boss located on an extended portion 2278 of the base body 424′ to place landmarks 114′ in the secondary patient tissue area 110′ and a guiding boss located on a central portion 2280 of the base body to place a landmark 114′ in the primary patient tissue area 108′.
The guiding boss 428′ located on the central portion 2280 of the base body 424′ in the guides 416′ of FIGS. 30-39 is noticeably larger than the other guiding boss(es), and may serve several functions for the guides 416′. The guiding boss 428′ located on the central portion 2280 of the base body 424′ may guide a landmark 1114 through a guiding bore 430′ thereof; may guide a rasp, drill, or other tissue modification tool (not shown) therethrough, optionally providing a “stop” function to limit insertion of the tissue modification tool into the underlying patient tissue; and/or may serve as a handling boss for user manipulation by hand and/or with a handling tool.
The guides 416′ of FIGS. 30-39 differ from each other mainly in the number and configuration(s) of extended portions 2278, which may be chosen to aid in stability, positive location, or any other characteristic/property of the guide with respect to the patient tissue area(s) 108′ and/or 110′. As with all embodiments of the present invention, any extended portions 2278 present might include at least a portion of the lower base surface 520′ or another patient-specific feature, or might be generic in structure. In cases where an extended portion 2278 is generic in structure, the location and/or dimensions of the extended portion may have patient-specific aspects in order to provide some locating function or assistance to the user. The extended portions 2278 shown in FIGS. 30-39 have locations, configurations, numbers, and are otherwise depicted in arrangements which help illustrate examples of guides 416′ for various use environments of the present invention. The depicted guides 416′ are not limiting as to the extended portions or any other properties of guides (not shown) for particular use environments of the present invention, which can be provided by one of ordinary skill of the art in a particular situation.
In FIGS. 30-31, three extended portions 2278 have segments of the lower base surface 520′ which contact different portions of the secondary patient tissue area 110′ (e.g., an acetabular rim) while a “central” portion of the lower base surface 520′, located on or near the central portion 2280 of the base body 424′, contacts the primary patient tissue area 108′.
In FIGS. 32-33, three extended portions 2278 have segments of the lower base surface 520′ which contact different portions of the secondary patient tissue area 110′ (e.g., an acetabular rim) while a “central” portion of the lower base surface 520′, located on or near the central portion 2280 of the base body 424′, contacts the primary patient tissue area 108′.
In FIGS. 34-35, four extended portions 2278 have segments of the lower base surface 520′ which contact different portions of the secondary patient tissue area 110′ (e.g., an acetabular rim) while a “central” portion of the lower base surface 520′, located on or near the central portion 2280 of the base body 424′, contacts the primary patient tissue area 108′.
In FIGS. 36-37, five extended portions 2278 have segments of the lower base surface 520′ which contact different portions of the secondary patient tissue area 110′ (e.g., an acetabular rim) while a “central” portion of the lower base surface 520′, located on or near the central portion 2280 of the base body 424′, contacts the primary patient tissue area 108′.
In FIGS. 38-39, a single extended portion 2278 has an elongated segment of the lower base surface 520′ which contacts at least a portion of the secondary patient tissue area 110′ (e.g., an acetabular rim) while a “central” portion of the lower base surface 520′, located on or near the central portion 2280 of the base body 424′, contacts the primary patient tissue area 108′. It is contemplated that a plurality of slightly different guides 416 may be prepared for a particular surgical procedure, to allow desired landmark 114 placement regardless of intraoperative complications. For example, because the user will not necessarily be able to clear away surrounding patient tissue in situ as preoperatively planned, several guides 416 based upon differently sized, shaped, and/or oriented guide blanks 940 may be provided. Though each of these alternate guides 416 may be configured for placement of landmarks 114 in the same positions, the base bodies 424 may mate with different amounts and/or locations of the primary and/or secondary patient tissue areas 108 and 110. The user can then select one guide 416 from a range of alternates available, depending upon how much of the primary and/or secondary patient tissue area 108 and 110 was actually able to be substantially prepared for mating with the guide 416. As a variation of this option, a range of guides 416 embodying different landmark 114 placement schemes could be provided, with the user choosing one of the range of guides 416 once the true condition of the patient tissue can be seen during the surgical procedure. In this latter situation, a range of surgical plans are made preoperatively and the user chooses one of those plans for proceeding after the surgical procedure is underway.
An prosthetic implant is used as an example herein. However, it is contemplated that the disclosed guide 416 may be used additionally or alternatively with an instrument, such as that disclosed in co-pending U.S. patent application Ser. No. 13/282,528, filed Oct. 27, 2011, titled “System and Method for Assisting with Arrangement of a Stock Instrument with Respect to a Patient Tissue” and claiming priority to U.S. Provisional Patent Application No. 61/408,376, filed Oct. 29, 2010 and titled “System and Method for Assisting with Arrangement of a Stock Instrument with Respect to a Patient Tissue”, the entire contents of both of which are incorporated herein by reference.
While aspects of the present invention have been particularly shown and described with reference to the preferred embodiment above, it will be understood by those of ordinary skill in the art that various additional embodiments may be contemplated without departing from the spirit and scope of the present invention. For example, the specific methods described above for using the guides 416 are merely illustrative; one of ordinary skill in the art could readily determine any number of tools, sequences of steps, or other means/options for placing the above-described apparatus, or components thereof, into positions substantively similar to those shown and described herein. Any of the described structures and components could be integrally formed as a single piece or made up of separate sub-components, with either of these formations involving any suitable stock or bespoke components and/or any suitable material or combinations of materials; however, the chosen material(s) should be biocompatible for most applications of the present invention. The mating relationships formed between the described structures need not keep the entirety of each of the “mating” surfaces in direct contact with each other but could include spacers or holdaways for partial direct contact, a liner or other intermediate member for indirect contact, or could even be approximated with intervening space remaining therebetween and no contact. Though certain components described herein are shown as having specific geometric shapes, all structures of the present invention may have any suitable shapes, sizes, configurations, relative relationships, cross-sectional areas, or any other physical characteristics as desirable for a particular application of the present invention. An adhesive (such as, but not limited to, bone cement) could be used in conjunction with the system and method described herein. The guide 416 may include a plurality of structures cooperatively forming the base body and temporarily or permanently attached together in such a manner as to permit relative motion (e.g., pivoting, sliding, or any other motion) therebetween. Any structures or features described with reference to one embodiment or configuration of the present invention could be provided, singly or in combination with other structures or features, to any other embodiment or configuration, as it would be impractical to describe each of the embodiments and configurations discussed herein as having all of the options discussed with respect to all of the other embodiments and configurations. A device or method incorporating any of these features should be understood to fall under the scope of the present invention as determined based upon the claims below and any equivalents thereof.
Other aspects, objects, and advantages of the present invention can be obtained from a study of the drawings, the disclosure, and the appended claims.

## Claims

1. An apparatus for associating a plurality of landmarks with a patient tissue, the patient tissue including a primary patient tissue area forming an abutment surface for an implant, and an anatomically differentiated bordering secondary patient tissue area excluded from the abutment surface, the apparatus being at least partially customized responsive to preoperative imaging of the patient tissue, the apparatus comprising:
means for mating with the primary patient tissue area in a preselected relative orientation;
means for fixing a first landmark to the primary patient tissue area in at least one of a predetermined marking location and a predetermined marking trajectory, into the abutment surface, the first landmark directly related to a planned position of an implant onto the primary patient tissue area;
means for fixing a second landmark to the secondary patient tissue area in at least one of a predetermined marking location and a predetermined marking trajectory excluded from the abutment surface; and
a pin used as the second landmark, the pin having an elongated portion being a guidewire configured to project out of the secondary patient tissue area to be used as guide for the predetermined marking trajectory, the predetermined marking trajectory being that of a tool altering the abutment surface based on the planned position of the implant after removal of the apparatus.

2. The apparatus of claim 1, wherein the means for mating with the primary patient tissue area includes means for mating with the secondary patient tissue area in a preselected relative orientation while the means for mating is mated with the primary patient tissue area.

3. The apparatus of claim 1, wherein the means for mating with the primary patient tissue area includes:
a base having a lower base surface contoured to mate with both the primary and secondary patient tissue areas in a preselected relative orientation, the lower base surface being spaced apart from an upper base surface by a base body; and
wherein the means for fixing a first landmark to the primary patient tissue area includes:
a plurality of base apertures extending between the upper and lower base surfaces through the base body, and a plurality of guiding bosses protruding from the base, each guiding boss having a guiding bore extending therethrough, each guiding bore extending collinearly with a corresponding base aperture to permit insertion of a first landmark through the apparatus; and
wherein each guiding bore and corresponding base aperture cooperatively define at least one of the predetermined marking location and the predetermined marking trajectory for the first landmark.

4. The apparatus of claim 1, wherein the planned position provided by the means for fixing the first landmark is a planned center of a stem of the implant.

5. The apparatus of claim 1, wherein the primary patient tissue area is in the glenoid fossa, and the secondary patient tissue area is a portion of a scapula outside of the glenoid fossa.

6. The apparatus of claim 5, wherein the means for fixing a second landmark defines a cavity for clamping onto opposite sides of a rim of the glenoid in the secondary patient tissue area.

7. An apparatus for associating a plurality of landmarks with a patient tissue, each landmark being associated with the patient tissue in at least one of a predetermined marking location and a predetermined marking trajectory, the patient tissue including a primary patient tissue area defined by a glenoid fossa and forming an abutment surface for an implant, and an anatomically differentiated bordering secondary patient tissue area excluded from the abutment surface and defined by a portion of a scapula outside of the glenoid fossa, the apparatus being at least partially customized responsive to preoperative imaging of the patient tissue, the apparatus comprising:
a base having a lower base surface contoured to mate with both the primary and secondary patient tissue areas in a preselected relative orientation, the lower base surface being spaced apart from an upper base surface by a base body;
a plurality of base apertures extending between the upper and lower base surfaces through the base body;
a plurality of guiding bosses protruding from the base, each guiding boss having a guiding bore extending therethrough, each guiding bore extending collinearly with a corresponding base aperture to permit insertion of a landmark through the apparatus; and
a pin having an elongated body;
wherein each guiding bore and corresponding base aperture cooperatively define at least one of the predetermined marking location and the predetermined marking trajectory for the landmark; and
wherein at least one landmark is guided by the apparatus into engagement with a marking location in the glenoid surface and into the abutment surface, and at least one landmark is the pin guided by the apparatus into engagement with a marking location in the portion of the scapula outside of the glenoid fossa and excluded from the abutment surface, such that a portion of the elongated body is a guidewire projecting out of the secondary patient tissue area to be used as guide for the predetermined marking trajectory.

8. The apparatus of claim 7, wherein at least one guiding boss protrudes from the upper base surface.

9. The apparatus of claim 7, including at least one handling boss protruding from the base, the handling boss being configured for manipulation by the user to at least partially control a position of the apparatus.

10. The apparatus of claim 9, wherein the handling boss is a guiding boss.

11. The apparatus of claim 9, wherein the handling boss is shaped to selectively interact with a user-manipulated handling tool.

12. The apparatus of claim 7, wherein the at least one landmark into engagement with the marking location in the glenoid surface is directly related to a planned position of an implant onto the glenoid surface.

13. The apparatus of claim 12, wherein the predetermined marking trajectory of the pin is representative of a trajectory of a tool altering the abutment surface based on the planned position of the implant.

14. The apparatus of claim 12, wherein the planned position provided by the at least one landmark is a center of a stem of the implant.

15. The apparatus of claim 7, wherein the base defines a cavity for clamping onto opposite sides of a rim of the glenoid in the secondary patient tissue area.