Source: https://patents.google.com/patent/US9289253B2/en
Timestamp: 2019-04-24 17:23:31+00:00

Document:
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.
This application is a continuation-in-part of U.S. application Ser. No. 12/893,306, filed Sep. 29, 2010, which is a continuation-in-part of U.S. application Ser. No. 12/888,005, filed Sep. 22, 2010, which is a continuation-in-part of U.S. application Ser. No. 12/714,023, filed Feb. 26, 2010, which is: a continuation-in-part of U.S. application Ser. No. 12/571,969, filed Oct. 1, 2009, which is a continuation-in-part of U.S. application Ser. No. 12/486,992, filed Jun. 18, 2009, and is a continuation-in-part of U.S. application Ser. No. 12/389,901, filed Feb. 20, 2009, which is a continuation-in-part of U.S. application Ser. No. 12/211,407, filed Sep. 16, 2008, which is a continuation-in-part of U.S. application Ser. No. 12/039,849, filed Feb. 29, 2008, which: (1) claims the benefit of U.S. Provisional Application No. 60/953,620, filed on Aug. 2, 2007, U.S. Provisional Application No. 60/947,813, filed on Jul. 3, 2007, U.S. Provisional Application No. 60/911,297, filed on Apr. 12, 2007, and U.S. Provisional Application No. 60/892,349, filed on Mar. 1, 2007; (2) is a continuation-in-part U.S. application Ser. No. 11/756,057, filed on May 31, 2007, which claims the benefit of U.S. Provisional Application No. 60/812,694, filed on Jun. 9, 2006; (3) is a continuation-in-part of U.S. application Ser. No. 11/971,390, filed on Jan. 9, 2008, which is a continuation-in-part of U.S. application Ser. No. 11/363,548, filed on Feb. 27, 2006; and (4) is a continuation-in-part of U.S. Application Ser. No. 12/025,414, filed on Feb. 4, 2008, which claims the benefit of U.S. Provisional Application No. 60/953,637, filed on Aug. 2, 2007.
The present teachings provide patient-specific guides for shoulder arthroplasty.
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.
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.
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.
a resection formation provided at the periphery of the cap, the resection formation being configured for guiding a resection of the anatomic neck of the humeral head.
2. The orthopedic device of claim 1, wherein the resection formation is a slot along a portion of the periphery of the cap at a patient-specific orientation relative to the alignment pin.
3. The orthopedic device of claim 1, wherein the resection formation is an edge along a portion of periphery of the cap.
4. The orthopedic device of claim 1, further comprising the alignment pin.
5. The orthopedic device of claim 4, further comprising a sizer template mountable over the alignment pin after the humeral head is resected and the patient-specific alignment guide is removed.
6. The orthopedic device of claim 1, further comprising a sizer template having a radial slot, the sizer template mountable over the alignment pin after the humeral head is resected and the patient-specific alignment guide is removed.
wherein the alignment guide is configured to be removed from the humeral head after insertion of the alignment pin into the humeral head without removing the alignment pin.
8. The orthopedic device of claim 7, further comprising the alignment pin.
9. The orthopedic device of claim 7, wherein the resection slot extends along a portion of the periphery of the cap.
10. The orthopedic device of claim 7, further comprising a resection formation provided at the periphery of the cap, the resection formation being a resection slot configured for guiding a resection of the anatomic neck of the humeral head.
the tab has a width less than a diameter of the elongated tubular element.

References: Application No. 60
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