PATIENT-SPECIFIC SHOULDER GUIDE

Abstract

An orthopedic device for a shoulder joint includes a patient-specific alignment guide. The alignment guide includes a cap having a three-dimensional engagement surface customized in a pre-operative plan by computer imaging to be complementary and closely mate and conform to a humeral head of a proximal humerus of a patient. The alignment guide includes a tubular element extending from the cap and defining a longitudinal guiding bore for guiding an alignment pin at a patient-specific position and orientation determined in the pre-operative plan, and an orientation feature on the cap. The orientation feature is designed to orient the cap relative to the humeral head when the orientation feature is aligned with a landmark of the proximal humerus.

Description

INTRODUCTION

The present teachings provide patient-specific guides for shoulder arthroplasty.

SUMMARY

The present teachings provide an orthopedic device for a shoulder joint that includes a patient-specific alignment guide. The alignment guide includes a cap having a three-dimensional engagement surface customized in a pre-operative plan by computer imaging to be complementary and closely mate and conform to a humeral head of a proximal humerus of a patient. The alignment guide includes a tubular element extending from the cap and defining a longitudinal guiding bore for guiding an alignment pin at a patient-specific position and orientation determined in the pre-operative plan, and an orientation feature on the cap. The orientation feature is designed to orient the cap relative to the humeral head when the orientation feature is aligned with a landmark of the proximal humerus.

The present teachings also provide a patient-specific alignment guide including a cap having a three-dimensional engagement surface customized in a pre-operative plan by computer imaging to closely mate and conform to a corresponding humeral head of a proximal humerus of a patient. The alignment guide includes a tubular element extending from the cap and defining a longitudinal guiding bore for guiding an alignment pin at a patient-specific position and orientation determined in the pre-operative plan, and a tab extending from the cap. The tab is configured to be at least partially received into a bicipital groove of the proximal humerus.

The present teachings provide a method of preparing a shoulder joint for an implant. The method includes mounting a patient-specific alignment guide including a curved cap with a three-dimensional engagement surface custom-made by computer imaging to a complementary and closely conforming humeral head of a patient's proximal humerus. The method includes passing an alignment pin through a longitudinal guiding bore of a tubular element extending from the cap of the patient-specific alignment guide, inserting the alignment pin through the humeral head and resecting the humeral head through a resection slot of the patient specific guide and forming a resected surface.

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

BRIEF DESCRIPTION OF THE DRAWINGS

The present teachings will become more fully understood from the detailed description and the accompanying drawings, wherein:

FIG. 1 is a perspective view of a proximal humerus of a patient;

FIG. 2 is an environmental view of a patient-specific guide with an alignment pin for the proximal humerus according to the present teachings;

FIG. 3 is a side view of the proximal humerus with the alignment pin of FIG. 2 after resection of a head of the proximal humerus using the patient-specific guide of FIG. 2; and

FIG. 4 is a plan view of a sizer used with the alignment pin of FIG. 2 after resection of the head of the proximal humerus.

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.

The present teachings generally provide patient-specific surgical instruments that include, for example, alignment guides, drill guides, templates, cutting/resection guides for use in shoulder joint replacement, shoulder resurfacing procedures and other procedures related to the shoulder joint or the various bones of the shoulder joint. The patient-specific instruments can be used either with conventional implant components or with patient-specific implant components that are prepared using computer-assisted image methods. Computer modeling for obtaining three dimensional images of the patient's anatomy using MRI or CT scans of the patient's anatomy, the patient specific prosthesis components and the patient-specific guides, templates and other instruments, can be designed using various CAD programs and/or software available, for example, by Materialise USA, Ann Arbor, Mich.

The patient-specific instruments and any associated patient-specific implants can be generally designed and formed using computer modeling based on the patient's 3-D anatomic image generated from image scans including, X-rays, MRI, CT, ultrasound or other scans. The patient-specific instruments can have a three-dimensional engagement surface that is complementary and made to conformingly contact and match at only one position a three-dimensional image of the patient's bone surface (which can be imaged selectively with associated soft tissues or without soft tissue, i.e., an actual bone surface), by the computer methods discussed above. The patient-specific instruments can include custom-made guiding formations, such as, for example, guiding bores or cannulated guiding posts or cannulated guiding extensions or receptacles that can be used for supporting or guiding other instruments, such as drill guides, reamers, cutters, cutting guides and cutting blocks or for inserting pins or other fasteners according to a surgeon-approved pre-operative plan.

In various embodiments, the patient-specific instruments can also include one or more patient-specific cutting guides for receiving and guiding a cutting blade at corresponding patient-specific resection orientations relative to a selected anatomic axis for the specific patient. The patient-specific instruments can also include guiding or orientation formations and features for guiding the implantation of patient-specific or off-the-shelf implants associated with the surgical procedure. The geometry, shape and orientation of the various features of the patient-specific instruments, as well as various patient-specific implants, if used, can be determined during the pre-operative planning stage of the procedure in connection with the computer-assisted modeling of the patient's anatomy. During the pre-operative planning stage, patient-specific instruments, custom, semi-custom or non custom implants and other non custom tools, can be selected and the patient-specific components can be manufactured for a specific-patient with input from a surgeon or other professional associated with the surgical procedure, as described in the commonly assigned and co-pending patent applications listed in the cross-reference section and incorporated herein by reference.

In the following discussion, the terms “patient-specific”, “custom-made” or “customized” are defined to apply to components, including tools, implants, portions or combinations thereof, which include certain geometric features, including surfaces, curves, or other lines, and which are made to closely conform as mirror-images or negatives or complementary surfaces of corresponding geometric features or anatomic landmarks of a patient's anatomy obtained or gathered during a pre-operative planning stage based on 3-D computer images of the corresponding anatomy reconstructed from image scans of the patient by computer imaging methods. Further, patient specific guiding features, such as, guiding apertures, guiding slots, guiding members or other holes or openings that are included in alignment guides, drill guides, cutting guides, rasps or other instruments or in implants are defined as features that are made to have positions, orientations, dimensions, shapes and/or define cutting planes and axes specific to the particular patient's anatomy including various anatomic or mechanical axes based on the computer-assisted pre-operative plan associated with the patient.

The prepared patient-specific alignment or resection guides can be configured to mate in alignment with natural anatomic landmarks by orienting and placing the corresponding alignment guide intra-operatively on top of the bone to mate with corresponding landmarks. The anatomic landmarks function as passive fiducial identifiers or fiducial markers for positioning of the various alignment guides, resection guides or other patient-specific instruments.

The various patient-specific alignment guides can be made of any biocompatible material, including, polymer, ceramic, metal or combinations thereof. The patient-specific alignment guides can be disposable and can be combined or used with reusable and non patient-specific cutting and guiding components.

Referring to FIG. 1, a proximal portion of a humerus 80 of a patient is illustrated schematically to indicate various anatomic features and landmarks. The humerus 80 includes a humeral head 82, a shaft 94, an anatomic neck 84, a surgical neck 92, a greater tuberosity (tubercle) 86, a lesser tuberosity 88 and a bicipital groove (intertubercular groove, or intertubercular sulcus) 90 between the greater and lesser tuberosities 86, 88.

Referring to FIG. 2, an exemplary patient-specific guide 100 for the proximal humerus 80 of a specific patient is illustrated. The patient-specific guide 100 can be an alignment guide for correctly orienting and guiding an alignment pin 120. The alignment pin 120 can be used as a reference pin for guiding other instruments or templates or sizers, and also as a securing device during resection. The patient-specific guide 100 can also optionally include a resection guide for guiding a blade to resect the head 82 of the humerus 80. The patient-specific guide 100 can be in the form of a three-dimensional shell or cap 102 that fits over the head 82 of the humerus 80 and is substantially in the shape of the head 82 of the humerus 80. The cap 102 can includes a patient-specific three-dimensional curved engagement surface 104 that is complementary to the surface of the head 82 of the humerus 80 and fits only in one position on the head 82 of the humerus 80. In this respect, the engagement surface 104 can be generally concave, but can also include convex portions corresponding to concave portions of the head 82. Although the outer surface of the cap 102 can have any shape, for a thin stretchable cap 102 the outer surface can be generally convex or semi-spherical. In one embodiment, the cap 102 can terminate at or about the anatomic neck 84. The patient-specific guide 100 can include an alignment formation 110, which can be in the form of an elongated tubular element 110 extending from the cap 102 and having an elongated open ended guiding bore 112. The guiding bore 112 is designed during the pre-operative plan with input from the surgeon such that an alignment pin 120 can be guided by the bore to a predetermined location on the resected surface 96 of the humerus, either centrally, as shown in FIG. 3, or at an offset and at patient-specific orientation, either perpendicularly or at an angle to a planned resected surface 96. The alignment pin 120 can be driven through the cancellous bone of the humerus 80 all the way through the lateral cortex to help secure the alignment pin 12, as shown in FIG. 2. In some procedures, the alignment pin 120 can also be used to guide a separate cutting guide for resecting the head 82 after the patient-specific guide 100 is removed.

The patient-specific guide 100 can include an orientation feature 116 that points to an anatomic feature selected during the pre-operative plan to directly guide the patient-specific guide 100 into the proper orientation on the humeral head 82 easily and without other visual alignment adjustments. The orientation feature 116 can be, for example, an etching or other marking that can be aligned to point to the bicipital groove 90. In another embodiment, the orientation feature 116 can be a small protuberance or tab 116 extending from the cap 102 toward the bicipital groove 90 or received at least in part into the bicipital groove 90 to align and position the patient-specific guide 100 quickly and correctly. The tab 116 can be sized and shaped to be fit into a corresponding portion of the bicipital groove 90.

The patient-specific guide 100 can also include a resection formation 106 defined along at least a portion of the periphery or edge of the cap 102. The resection formation 106 can be an external edge of the cap 102 or a slot formed through the cap 102 for guiding a blade or other cutting instrument to guide a planar resection of the humeral head 82 at the anatomic neck 84. In some embodiments, the resection formation 106 can be located in accordance with a surgeon preference or surgical technique during the pre-operative plan of the patient. The resection can be performed without removing the alignment pin 120, by cutting through the humeral head 82 around the alignment pin 120. The patient-specific guide 100 can then be removed leaving the alignment pin 120 through the resected surface 96, as shown in FIG. 3.

Referring to FIG. 4, a sizer template 130 can be optionally used for sizing and selecting an implant component, if there is a change from the pre-operative plan or for verification purposes. The sizer template 130 can have a handle 134 coupled to a planar tray portion 130 that is placed over the resected surface 96. The sizer template 130 can be cleat-shaped with a slot 132 that can receive the alignment pin 120 and size the resected surface 96 without removing the alignment pin 120.

In operation, the patient-specific alignment guide 100 can be oriented and placed on the humeral head 82 such that the orientation feature 116 is oriented and points toward the bicipital groove 90. An alignment pin 120 is passed through the guiding bore 112 and through the humeral head 82 to secure the patient-specific alignment guide 100 on the humerus 80. A blade can be guided through the resection formation 106 and the humeral head 82 can be resected around the alignment pin 120. The patient-specific alignment guide 100 can then be removed. The alignment pin 120 can remain attached to the resected surface 96 to optionally guide a sizer template 130 or other instrument, after the patient-specific alignment guide 100 is removed, to prepare the resected surface 96 for an implant.

The foregoing discussion discloses and describes merely exemplary arrangements of the present teachings. Furthermore, the mixing and matching of features, elements and/or functions between various embodiments is expressly contemplated herein, so that one of ordinary skill in the art would appreciate from this disclosure that features, elements and/or functions of one embodiment may be incorporated into another embodiment as appropriate, unless described otherwise above. Moreover, many modifications may be made to adapt a particular situation or material to the present teachings without departing from the essential scope thereof. One skilled in the art will readily recognize from such discussion, and from the accompanying drawings and claims, that various changes, modifications and variations can be made therein without departing from the spirit and scope of the present teachings as defined in the following claims.

Claims

1.-20. (canceled)

21. An alignment guide comprising: a body having a three-dimensional shape, wherein the body defines at least one aperture therein to guide one or more of a fastener or pin into a bone; anda projection extending from an outer periphery of the body, the projection designed to orient the body and the at least one aperture relative to the bone by alignment of the projection.

22. The guide of claim 21, wherein the body includes an engagement surface customized in a pre-operative plan by computer imaging to be complementary and closely mate and conform to a portion of a head of the bone of a specific patient.

23. The guide of claim 21, wherein the body includes an elongated tubular element extending from a remainder of the body, wherein the at least one aperture is a longitudinal guiding bore defined by the elongated tubular element.

24. The guide of claim 21, wherein the body, the projection and the aperture are configured to mount the guide to a head of the bone via the one or more of the fastener or pin at a patient-specific position and an orientation determined in a pre-operative plan.

25. The guide of claim 21, wherein the body, the projection and the aperture are configured to mount the guide to a head of the bone to guide a resection of the bone at a neck to remove the head.

26. The guide of claim 25, wherein the resection is at a patient-specific position and an orientation determined in a pre-operative plan.

27. The guide of claim 21, wherein the projection is configured to be aligned with a landmark of the bone, and wherein the landmark is a bicipital groove of a humeral head.

28. The guide of claim 27, wherein the projection is sized and shaped to be received at least partially in the bicipital groove.

29. The guide of claim 21, wherein the body further defines a slot therein, the slot extending along a portion of the outer periphery of the body.

30. An alignment guide comprising: a body having a three-dimensional shape, wherein the body defines at least one aperture therein to guide one or more of a fastener or pin into a bone; andan orientation feature on an outer periphery of the body, the orientation feature designed to orient the body and the at least one aperture relative to the bone by alignment of the orientation feature.

31. The guide of claim 30, wherein the orientation feature comprises one of: an etching, a marking or a projection extending from the outer periphery of the body.

32. The guide of claim 30, wherein the body includes an engagement surface customized in a pre-operative plan by computer imaging to be complementary and closely mate and conform to a portion of a head of the bone of a specific patient.

33. The guide of claim 30, wherein the body includes an elongated tubular element extending from a remainder of the body, wherein the at least one aperture is a longitudinal guiding bore defined by the elongated tubular element.

34. The guide of claim 30, wherein the body, the orientation feature and the aperture are configured to mount the guide to a head of the bone via the one or more of the fastener or pin at a patient-specific position and an orientation determined in a pre-operative plan.

35. The guide of claim 30, wherein the body, the orientation feature and the aperture are configured to mount the guide to a head of the bone to guide a resection of the bone at a neck to remove the head.

36. The guide of claim 30, wherein the body further defines a slot therein, the slot extending along a portion of the outer periphery of the body.

37. An alignment guide comprising: a body having a tubular shape, wherein the body defines at least one aperture therein to guide one or more of a fastener or pin into a bone; anda projection extending from an outer periphery of the body, the projection designed to orient the body and the at least one aperture relative to the bone by alignment of the projection.

38. The guide of claim 37, wherein the body further defines a slot therein, the slot extending along a portion of the outer periphery of the body.

39. The guide of claim 37, wherein the projection is configured to be aligned with a landmark of the bone, and wherein the landmark is a bicipital groove of a humeral head.

40. The guide of claim 39, wherein the projection is sized and shaped to be received at least partially in the bicipital groove.