Source: https://patents.google.com/patent/US9480580B2/en
Timestamp: 2019-04-20 11:18:52+00:00

Document:
2013-12-09 Assigned to BIOMET MANUFACTURING CORPORATION reassignment BIOMET MANUFACTURING CORPORATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MORRISON, BRYAN, PERRY, LANCE D., SLONE, W. JASON, METZGER, ROBERT, BOLLINGER, MARK A., MERIDEW, JASON D., SMITH, AARON P., WHITE, JOHN R., WITT, TYLER D.
A method for inserting an acetabular implant into the acetabulum of a patient. The method includes engaging a patient-specific surface of acetabular alignment guide to a complementary rim surface and periacetabular area of a patient. A plurality of alignment pins are inserted through corresponding alignment apertures of the acetabular alignment guide and into the periacetabular area of the patient. The acetabular alignment guide is removed without removing the alignment pins from the patient. An alignment adapter is coupled to an acetabular inserter over the alignment pins and an acetabular implant is implanted using the acetabular inserter.
This application is a divisional of U.S. application Ser. No. 13/111,007 filed on May 19, 2011, which claims the benefit of U.S. Provisional Application No. 61/446,660 filed on Feb. 25, 2011.
This application is a divisional of U.S. application Ser. No. 13/111,007 filed May 19, 2011, which is a continuation-in-part of: (1.) U.S. application Ser. No. 13/041,469 filed on Mar. 7, 2011, (2.) U.S. application Ser. No. 13/041,495, filed on Mar. 7, 2011, (3.) U.S. application Ser. No. 13/041,665 filed on Mar. 7, 2011, now U.S. Pat. No. 8,535,387 issued on Sep. 17, 2013, and (4.) U.S. application Ser. No. 13/041,883 filed on Mar. 7, 2011, each of which is a continuation-in-part of U.S. application Ser. No. 12/978,069 filed on Dec. 23, 2010, now U.S. Pat. No. 8,568,487 issued on Oct. 29, 2013, which is a continuation-in-part of U.S. application Ser. No. 12/973,214 filed on Dec. 20, 2010, which is a continuation-in-part of U.S. application Ser. No. 12/955,361 filed on Nov. 29, 2010, now U.S. Pat. No. 8,591,516 issued on Nov. 26, 2013, which is a continuation-in-part of: (1.) U.S. application Ser. No. 12/938,913 filed on Nov. 3, 2010, and (2.) U.S. application Ser. No. 12/938,905 filed on Nov. 3, 2010, each of which is a continuation-in-part of U.S. application Ser. No. 12/893,306 filed on Sep. 29, 2010, which is a continuation-in-part of U.S. application Ser. No. 12/888,005 filed on Sep. 22, 2010, now U.S. Pat. No. 8,377,066 issued on Feb. 19, 2013, which is a continuation-in-part of U.S. application Ser. No. 12/714,023 filed on Feb. 26, 2010, now U.S. Pat. No. 8,241,293 issued on Aug. 14, 2012, which is a continuation-in-part of U.S. application Ser. No. 12/571,969 filed on Oct. 1, 2009, which is a continuation-in-part of U.S. application Ser. No. 12/486,992 filed on Jun. 18, 2009, which is a continuation-in-part of U.S. application Ser. No. 12/389,901 filed on Feb. 20, 2009, now U.S. Pat. No. 8,133,234 issued on Mar. 13, 2012, which is a continuation-in-part of U.S. application Ser. No. 12/211,407 filed on Sep. 16, 2008, which is a continuation-in-part of U.S. application Ser. No. 12/039,849 filed on Feb. 29, 2008, now U.S. Pat. No. 8,282,646 issued on Oct. 9, 2012, 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 of U.S. application Ser. No. 11/756,057 filed on May 31, 2007, now U.S. Pat. No. 8,092,465 issued on Jan. 10, 2012, 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, now U.S. Pat. No. 8,070,752 issued on Dec. 6, 2011, which is a continuation-in-part of U.S. application Ser. No. 11/363,548 filed on Feb. 27, 2006, now U.S. Pat. No. 7,780,672, issued on Aug. 24, 2010; and (4) is a continuation-in-part of U.S. application Ser. No. 12/025,414 filed on Feb. 4, 2008, now U.S. Pat. No. 8,298,237 issued on Oct. 30, 2012, which claims the benefit of U.S. Provisional Application No. 60/953,637 filed on Aug. 2, 2007.
This application is a divisional of U.S. application Ser. No. 13/111,007 filed on May 19, 2011, which is a continuation-in-part of U.S. application Ser. No. 12/872,663 filed on Aug. 31, 2010, now U.S. Pat. No. 8,407,067 issued on Mar. 26, 2013, which claims the benefit of U.S. Provisional Application No. 61/310,752 filed on Mar. 5, 2010.
This application is a divisional of U.S. application Ser. No. 13/111,007 filed on May 19, 2011, which is a continuation-in-part of U.S. application Ser. No. 12/483,807 filed on Jun. 12, 2009, now U.S. Pat. No. 8,473,305 issued on Jun. 25, 2013, which is a continuation-in-part of U.S. application Ser. No. 12/371,096 filed on Feb. 13, 2009, which is a continuation-in-part of U.S. application Ser. No. 12/103,824 filed on Apr. 16, 2008, now abandoned, which claims the benefit of U.S. Provisional Application No. 60/912,178 filed on Apr. 17, 2007.
This application is a divisional of U.S. application Ser. No. 13/111,007 filed on May 19, 2011, which is a continuation-in-part of U.S. application Ser. No. 12/103,834 filed on Apr. 16, 2008, now U.S. Pat. No. 7,967,868 issued on Jun. 28, 2011, which claims the benefit of U.S. Provisional Application No. 60/912,178 filed on Apr. 17, 2007.
The present teachings provide a patient-specific acetabular alignment guide and related instruments for guiding an acetabular implant into the acetabulum of a patient.
The present teachings provide an acetabular device. In one aspect, the acetabular system includes a patient-specific acetabular alignment guide including a bone engagement surface. The bone engagement surface has a first portion configured and shaped to be conforming and complementary to an acetabular rim surface and a second portion configured and shaped to be conforming and complementary to a periacetabular area of an acetabulum of a patient. The acetabular alignment guide includes a plurality of guiding formations extending through the second portion for guiding a plurality of alignment pins therethrough. The bone engagement surface and the plurality of guiding formations are prepared from a three-dimensional model of the acetabulum of the specific patient reconstructed pre-operatively from a scan of the patient.
The acetabular device can also include an acetabular inserter including a handle, a shaft and an acetabular coupler and a first alignment adapter removably coupled to the shaft of the acetabular inserter. The first alignment adapter includes a plurality of apertures configured to correspond to the guiding formations of the acetabular alignment guide, such that the alignment pins can pass through the apertures of the alignment adapter after the acetabular alignment guide is removed without removing the alignment pins from the patient.
The present teachings also provide a method for inserting an acetabular implant into the acetabulum of a patient. The method includes engaging a patient-specific surface of the acetabular alignment guide to a complementary rim surface and periacetabular area of a patient and inserting a plurality of alignment pins through corresponding alignment apertures of the acetabular alignment guide and into the periacetabular area of the patient. The method further includes removing the acetabular alignment guide without removing the alignment pins from the patient, guiding a first alignment adapter coupled to an acetabular inserter over the alignment pins, and implanting the acetabular implant with the acetabular inserter.
The present teachings provide an acetabular device that includes an annular acetabular guide including a first surface and a second surface opposite to the first surface. The first surface is patient-specific and made to conform to an acetabular rim surface around an acetabulum of a patient in accordance with a three-dimensional image of the acetabulum of the patient. The acetabular guide includes a cylindrical inner guiding surface oriented at patient-specific anteversion and abduction angles relative to the first surface. The acetabular device also includes a patient-specific adapter having an outer surface mateable with the inner surface of the acetabular guide and having a quick-connection component for coupling to a non-custom acetabular instrument.
FIG. 14B is an environmental anterior view of the femoral implant of FIG. 14A.
The present teachings generally provide a patient-specific acetabular guide and associated inserter for use in orthopedic surgery, such as in joint replacement or revision surgery, for example. The patient-specific alignment guides can be used either with conventional or patient-specific implant components prepared with 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 and templates can be provided by various CAD programs and/or software available, for example, by Materialise USA, Ann Arbor, Mich.
Patient-specific alignment guides and implants are generally configured to match the anatomy of a specific patient. The patient-specific alignment guides are generally formed using computer modeling based on the patient's 3-D anatomic image and have an engagement surface that is made to conformingly contact and match a three-dimensional image/model of the patient's bone surface (with or without cartilage or other soft tissue), by the computer methods discussed above. The patient-specific alignment guides can include custom-made guiding formations, such as, for example, guiding bores or cannulated guiding posts or cannulated guiding extensions or receptacles that can be used for supporting or guiding other 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. The patient-specific alignment guides can be used in minimally invasive surgery, and in particular in surgery with multiple minimally-invasive incisions. Various alignment guides and pre-operative planning procedures are disclosed in commonly assigned and co-pending U.S. patent application Ser. No. 11/756,057, filed on May 31, 2007; U.S. patent application Ser. No. 12/211,407, filed Sep. 16, 2008; U.S. patent application Ser. No. 11/971,390, filed on Jan. 9, 2008, U.S. patent application Ser. No. 11/363,548, filed on Feb. 27, 2006; and U.S. patent application Ser. No. 12/025,414, filed Feb. 4, 2008. The disclosures of the above applications are incorporated herein by reference.
As disclosed, for example, in above-referenced U.S. patent application Ser. No. 11/756,057, filed on May 31, 2007; in the pre-operative planning stage for a joint replacement or revision procedure, an MRI scan or a series of CT scans of the relevant anatomy of the patient, such as, for example, the entire leg of the joint to be reconstructed, can be performed at a medical facility or doctor's office. The scan data obtained can be sent to a manufacturer. The scan data can be used to construct a three-dimensional image/model of the joint and provide an initial implant fitting and alignment in a computer file form or other computer representation. The initial implant fitting and alignment can be obtained using an alignment method, such as alignment protocols used by individual surgeons.
The outcome of the initial fitting is an initial surgical plan that can be printed or provided in electronic form with corresponding viewing software. The initial surgical plan can be surgeon-specific, when using surgeon-specific alignment protocols. The initial surgical plan, in a computer file form associated with interactive software, can be sent to the surgeon, or other medical practitioner, for review. The surgeon can incrementally manipulate the position of images of implant components in an interactive image of the joint. Additionally, the surgeon can select or modify resection planes, types of implants and orientations of implant insertion. For example, the surgeon may select patient-specific anteversion and abduction angles for acetabular implants, as discussed below. After the surgeon modifies and/or approves the surgical plan, the surgeon can send the final, approved plan to the manufacturer.
After the surgical plan is approved by the surgeon, patient-specific alignment guides can be developed using a CAD program or other imaging software, such as the software provided by Materialise, for example, according to the surgical plan. Computer instructions of tool paths for machining the patient-specific alignment guides can be generated and stored in a tool path data file. The tool path can be provided as input to a CNC mill or other automated machining system, and the alignment guides can be machined from polymer, ceramic, metal or other suitable material, and sterilized. The sterilized alignment guides can be shipped to the surgeon or medical facility, for use during the surgical procedure.
The present teachings provide a patient-specific acetabular guide and associated inserter for inserting an acetabular implant in the acetabulum of a patient's pelvis in a guided orientation at least about first and second non-parallel anatomic axes. Referring to FIGS. 1, 3A and 3B, the first anatomic axis indicated at “A”, passes through the acetabulum 82 of a patient's pelvis 80 (only half of the pelvis is shown) and is oriented generally in a superior/inferior direction relative to the patient. The second anatomic axis is indicated at “B” and is substantially perpendicular to the first axis A. As described below, the present teachings provide instruments and methods for guiding, orienting and positioning an acetabular implant 200 at a selected angle of anteversion relative to the axis A, as shown in FIG. 3A, and at a selected angle of abduction relative to the axis B, as also shown in FIG. 3B. The anteversion and abduction angles can be determined interactive or other surgeon input and can be patient-specific.
Referring to FIG. 1A, an exemplary acetabular guide 100 according to the present teachings can include a first surface 108 for engaging an area surrounding the acetabulum 82 and a second surface 110 opposite to the first surface 108. The acetabulum-engaging first surface 108 can be custom-made or patient-specific to conform and mirror an acetabular rim surface 84 around the acetabulum 82 of a specific patient by using three-dimensional image or model of the acetabulum and surrounding pelvic area of the patient, as described above. The first surface 108 enables the acetabular guide to nest or closely mate relative to the acetabulum 82 of the patient.
The acetabular guide 100 can be temporarily and removably attached to the pelvis 80 using temporary fasteners 120, such as bone nails or tacks, for example, passing through corresponding holes 104 through the acetabular guide 100. The acetabular guide 100 can be annular with an opening defined by an inner surface 102. The inner surface 102 can be, for example, a cylindrical surface. The inner surface 102 can be oriented relative to the first and second surfaces 108, 110 of the acetabular guide 100 to provide a selected anteversion angle about the first axis A and a selected abduction angle relative to the axis B, as shown in FIGS. 2, 3A and 3B. The anteversion and abduction angles can be surgeon-selected and patient-specific and can be determined with surgeon input during the pre-operative planning for the specific patient. Anteversion angles can be, for example, in the range of about 10-20 degrees forward relative to the first axis A, and adduction angles can be in the range of about 40-50 degrees downward relative to the second axis B.
Referring to FIGS. 2-4, the acetabular guide 100 can be attached to the pelvis 80 around the acetabulum 72 after the acetabulum 82 has been reamed and prepared for receiving the acetabular implant 200, such as the Magnum™ acetabular cup commercially available from Biomet, Inc., Warsaw, Ind. The acetabular implant 200 can be inserted into the prepared acetabulum 82 using an inserter 300 according to the present teachings. The inserter 300, which can also function as an impactor, can include a handle 304 with a proximal impaction surface 318, a shaft 302 and a guide-engaging portion 310 having a surface with a flat or planar portion 320. The guide-engaging portion 310 can have an outer surface 312, which conforms to and is mateable with the inner surface 102 of the acetabular guide 100 for guiding the acetabular implant 200. The inner surface 102 and the outer surface 312 can be cylindrical.
Referring to FIG. 4, the inserter 300 can engage the acetabular implant 200 via an intermediate member 250, such as the intermediate member of the Magnum™ system, which is commercially available from Biomet, Inc., Warsaw, Ind. More specifically, the inserter 300 can include a distal portion 314, such as a ball-bearing bushing, which can be inserted and engage a receptacle 252 of the intermediate member 250. The acetabular implant 200 can be mounted on the inserter 300 by aligning a plurality of fingers 254 of the intermediate member 250 with corresponding cut-outs 202 on a peripheral edge of the acetabular implant 200. The acetabular implant 200 can be secured to the inserter 300 by rotating the acetabular implant 200 relative to the insert 300 until a hand-tight fit is obtained.
Referring to FIG. 2, the inserter 300 with the acetabular implant 200 mounted thereon can be directed toward the acetabular guide 100. The outer surface 312 of the guide engaging portion 310 of the inserter 300 can be brought into contact with the inner surface 102 of the acetabular guide 100, guiding the acetabular implant 200 toward the selected anteversion and abduction orientation through the acetabular guide 100. The outer surface 312 of the guide engaging portion 310 can also provide an impaction-depth feedback by alignment with the inner surface 102 of the acetabular guide. Full impaction of the acetabular implant 200 into the acetabulum 82 can be indicated when planar portion 320 and/or outer surface 312 of the guide-engaging portion 310 of the inserter 300 are flush with and do not protrude over and above the second surface 110 of the acetabular guide 100. Depth indicia 322 can also be provided on the inserter shaft 302 or on the guide-engaging portion 310 of the inserter 300, as shown in FIG. 2.
After the acetabular implant 200 is fully seated in the acetabulum 82 in the selected anteversion and abduction orientations, the inserter 300 and intermediate member 250 can be removed. The temporary fasteners 120 can be removed and the acetabular guide released.
The acetabular guide 100 can be made of any biocompatible material, such as metal, ceramic or polymer. The acetabular guide 100 can be constructed by various manufacturing methods depending of the selected material, including, for example, machining, casting, molding, stereolithography or other layer deposition methods. In one aspect, the acetabular guide 100 can be made of disposable plastic material.
The patient-specific acetabular guide 100 can also be used with a standard (non patient-specific) modular reamer 331 fitted with a patient-specific reamer adapter 360 to ream the acetabulum of the specific patient in pre-planned patient-specific orientations. This allows the acetabular implant 200 to be received in the selected anteversion and abduction orientations, as shown in FIG. 4H and discussed in connection with FIGS. 4A-4H.
FIGS. 4A-4C illustrate an exemplary modular reamer 331 that includes a reamer driver 330 and a reamer head 350. The reamer driver 330 can be removably coupled to the reamer head 350 with a connecting mechanism 335, which can be a spring-loaded, or snap-fit or other type of releasable connection, including connections secured with a set screw or other easily removable fasteners. An exemplary quick-connect connection is illustrated in FIGS. 4A-4D and is also used to connect the reamer 331 to the reamer adapter 360, as illustrated in FIGS. 4E-4H.
The reamer head 350 can be in the form of a hollow cup with a semi-spherical reaming surface 353 bounded by a periphery 351. The reaming surface 353 defines a plurality of reaming formations or reaming teeth 357. A number of arms or rods 342 can be connected to the periphery 351 and form a first component of the quick-connect mechanism 335. The arms 342 can be attached to one another at a central hub 341 forming a frame 343, as shown in FIG. 4B.
The reamer driver 330 can include a handle or sleeve 332 receiving a driver shaft 334 for coupling to a driver tool at a proximal end (not shown) and having a distal connector 338. The distal connector 338 forms a second component of the quick connect mechanism 335, which is operated with a spring-loaded slider or trigger 336 coupled to the driver shaft 334. The distal connector 338 can include a number of openings or slots 344 and a corresponding number of movable or retractable pins 346. The number of slots 344 corresponds to the number of arms 342 and the slots 344 are sized and shaped to receive the arms 342. Although four arms, slots and pins are illustrated, a smaller or greater number can be used, for example two or three arms, slots and pins that can be evenly positioned radially about the reamer head 350. To connect the reamer driver 330 to the reamer head 350, the slots 344 are placed over the arms 342 with the pins 344 in their retracted position. The pins 344 can be retracted by moving the slider 336 in a direction away from the distal connector 338. When the slider 336 is released, the arms 342 are gripped between the pins 344 and the walls of the slots 344 and the reamer driver 330 is securely connected to the reamer head 350.
Referring to FIGS. 4E-4H, the patient-specific reamer adapter 360 can include can include a first portion 362 and a second portion 368. The first portion 362 can have an outer surface 364. The outer surface 364 can be, for example, cylindrical. The outer surface 364 can be shaped, sized and oriented to mate with the inner surface 102 of the patient-specific guide 100 to provide a selected and patient-specific anteversion angle about the first axis A and a selected abduction angle relative to the axis B, as shown FIG. 4H. In this respect, the outer surface 364 of the adapter 360 is patient specific.
The reamer adapter 360 can be coupled to the reamer with a quick-connect connection. For example, the reamer adapter 360 can be coupled between the reamer driver 330 and the reamer head 350 with corresponding components of the quick-connect mechanism 335 used for the connecting the reamer driver 330 to the reamer head 350. Referring to FIGS. 4E-4H, the first portion 362 can include a number of arms 370 coupled to a proximal periphery 363 of the first portion 262 and are configured to engage the distal connector 338 of the reamer driver 330, i.e. to be gripped in corresponding slots 344 by corresponding pins 346. In this regard, the arms 370 of the first portion 362 provide a component that is complementary to the quick-connect component of the reamer driver 330 and complete a quick-connect mechanism 335 between the reamer drier 330 and the reamer adapter 360.
Similarly, the second portion 368 of the reamer adapter 360 can include a quick-connect component complementary to the quick-connect component of the reamer head 350 to complete the quick-connect mechanism 335. More specifically, the second portion 368 can include a number of slots 374 and pin 372 for gripping the arms 342 of the reamer head 350. Accordingly, the same type of quick-connect mechanism 335 that is used to couple the reamer driver 330 to the reamer head 350 can be used to couple the reamer adapter 360 between the reamer driver 330 and the reamer head 350, as illustrated in FIGS. 4A and 4E. It is noted that the quick-connect mechanism 335 is not limited to the exemplary embodiment illustrated, but can be any quick-connect mechanism used for non-patient-specific modular reamers, include snap-fit, tapered connectors, threaded connectors, or any other connectors with complementary components “a” for the reamer driver 330 and “b” for the reamer head 350, which are then used in reverse order to couple the reamer adapter 360 therebetween in a sequence a-b-a-b. In the illustrated quick-connect mechanism 335, component “a” includes slots and pins and component “b” includes arms.
Referring to FIG. 4H, the assembled reamer 331 with the patient-specific adapter 360 can be used with the patient-specific acetabular guide 100 to ream the acetabulum 82 of the patient to receive an implant in a selected patient-specific orientation according to the pre-operative plan. As described above in relation to FIGS. 1-4, the acetabular guide 100 is attached to the acetabulum 82 in only one position, such that the inner surface 102 provides an orientation guide for the reamer head 350. In particular, the outer surface 364 of the reamer adapter 360 mates in a complementary close-fit manner with the inner surface 102 of the acetabular guide 100, such that the reamer head 350 can be oriented as specified in the pre-operative plan to ream the acetabulum in the selected anteversion and abduction orientations relative to the corresponding axes A and B. After the acetabulum 82 is reamed, the acetabular implant 200 can be impacted in the same selected orientation using the inserter/impactor 300 discussed in connection with FIGS. 2 and 3.
The exemplary acetabular guide 100 illustrated in FIGS. 1A, 2 and 4H is annular for placement around the acetabulum 82. In other embodiments, an acetabular guide 400 positioned only in a portion around the acetabulum 82 can also be used. Referring to FIGS. 5-10, the patient-specific acetabular alignment guide 400 and other instruments for guiding an acetabular implant are illustrated. The patient-specific acetabular alignment guide 400 can be prepared during a pre-operative plan for the surgical procedure based on a three-dimensional image of the relevant anatomy of the patient including portions of the pelvis 80, the acetabulum 82, the acetabular rim area 84, the periacetabular area and generally the hip joint of the patient. The three-dimensional image of the anatomy of the patient can be developed by commercially available software, as discussed above, using MRI, CT, X-rays or other scans of the particular patient.
Referring to FIGS. 5 and 6, the acetabular alignment guide 400 can include a first portion 402 configured and adapted to be positioned around the rim surface 84 of the acetabulum 82 and a second portion 404 configured and adapted to be positioned around the periacetabular area of the pelvis 80 of a specific patient. The acetabular alignment guide 400 can include a three-dimensional curved patient-specific bone engagement surface 408. The bone engagement surface 408 is defined to match complementarily to a portion of the acetabular rim surface 84 and a portion of an adjacent periacetabular area of the pelvis 80 of the patient for close contact/nesting thereon in only one position and orientation. The second portion 404 of the acetabular alignment guide 400 is designed during the pre-operative plan to define a plurality of elongated through-slots, apertures or other guiding formations 406 directed toward the periacetabular area for guiding a plurality of alignment pins 420 parallel to an acetabular centering axis CC, the location and orientation of which is determined according to the preoperative plan for the specific patient. The second portion 404 can be reinforced with additional materials and/or have thicker dimensions for stability.
Three guiding formations 406 in the form of through holes and a corresponding number of alignment pins 420 are illustrated in FIGS. 5 and 6. Depending on the patient and/or procedure, a different number of guiding formations 406 and alignment pins 420 can be used. The alignment pins 420 can be parallel defining a patient specific orientation and operable for locating the acetabular centering axis CC. The alignment pins 420 can removably guide along the same axis other instruments associated with the insertion of an acetabular implant 200 after the acetabular alignment guide 400 is removed, as shown in FIG. 7, for example. The orientation and location of the guiding formations 406 can be patient-specific and determined pre-operatively to facilitate guiding and supporting the various instruments used for positioning, inserting and impacting the acetabular implant 200, as discussed below.
Referring to FIG. 7, after the alignment pins 420 have been inserted into the bone, the acetabular alignment guide 400 can be removed. An acetabular positioner or inserter or inserter/impactor 450 can be guided by the alignment pins 420 for inserting the acetabular implant 200 in the acetabulum. The inserter 450 can include a handle 451 with a knob 453 and a shaft 452 coupled to a patient-specific alignment adapter 470. The patient-specific alignment adapter 470 can include an arm 474 defining a plurality of alignment apertures 478 complementary to the alignment pins 420, such that the alignment adapter 470 can removably slide over the alignment pins 420. In this respect, the shape and size of the arm 474 and the placement, arrangement and configuration of the alignment apertures 478 can be determined during the pre-operative plan to correspond to the guiding formations 406 of the acetabular alignment guide 400. The alignment adapter 470 can include a coupling opening 472 for removably receiving the shaft 452 of the inserter 450 or can be integrally coupled to the shaft 452 of the inserter 450. The coupling opening 472 can be, for example, an interference fitting or snap-on side slot. Alternatively, the coupling opening 472 can be an enclosed hole, which receives the shaft 452 of the inserter 450, when the shaft is modularly coupled to the inserter 450. The inserter 450 can be connected to and disconnected from the acetabular implant 200 with a coupler 480 at the distal end of the shaft 452 by rotating the knob 453. The coupler 480 can also be modularly connected to the shaft 452. During insertion of the acetabular implant 200, the alignment pins 420 help stabilize, guide and secure the orientation of the inserter/impactor 450 and acetabular implant 200 and place the acetabular implant 220 in the desired position and orientation relative to the acetabulum 82 as determined during the pre-operative plan using imaging scans of the patient.
Similar patient-specific alignment adapters 470 can be used for guiding other type of inserters or impactors or reamers with reamer driver handles or other instruments, such as, for example, reamers and impactors that can be used during the preparation and implantation procedure. Referring to FIGS. 9 and 10, first and second impactors (or other acetabular instruments) 500 a, 500 b are illustrated with respective first and second patient-specific alignment adapters 470 a, 470 b. The first impactor 500 a is an offset impactor 500 a generally used for minimally invasive procedures, and the second impactor 500 b is straight, non-offset impactor. Each of the first and second impactors 500 a, 500 b can be modular and include a handle 502 respectively coupled to a first shaft 504 a or second 504 b terminating at a coupler 510 with an end connector 512. The first shaft 504 a of the first impactor 500 a is offset relative to a longitudinal axis C (designed to coincide with the acetabular centering axis CC) passing through the handle 502 and the end connector 512. The shaft 504 b of the second impactor 500 b is coaxial with the handle 502.
As illustrated in FIG. 9, the offset first shaft 504 a can include a center portion 505 c offset and substantially parallel to the longitudinal axis C and first and second end portions 505 a, 505 b angled relative to the center portion 505 c for defining the offset. The first end portion 505 a can be cannulated or hollow for receiving a shaft 492 of a driver 490 coupled to the end connector 512, such that the end connector 512 can be secured to the acetabular implant 200 by rotating a knob 494 of the driver 490. The first alignment adapter 470 a includes a coupling opening 472 (enclosed hole or side opening/slot) through which the portion 505 a can pass through. As discussed above in connection with alignment adapter 470 and the inserter 450 of FIG. 7, the shape and size of the arm 474 and the placement and arrangement/configuration of the alignment apertures 478 can be determined during the pre-operative plan to correspond to the guiding formations 406 of the acetabular alignment guide 400 and the location and orientation of the alignment pins 420, such that the parallel alignment pins 420 can pass through the parallel alignment apertures 478 to guide the first impactor 500 a relative to the acetabular implant 200 and relative to the acetabulum 82. The first alignment adapter 470 a can be removably coupled to the first impactor 500 a and can be slidably adjusted in position relative to the first portion 505 a while maintaining the alignment orientation of the alignment apertures 406 relative to axis CC and the alignment pins 420.
Referring to FIG. 10, the second impactor 500 b can be used similarly. Because the shaft 504 b is substantially straight (not offset), the end connector 512 can be attached to the acetabular implant 200 by simply rotating the handle 502 or a knob attached to the handle (not shown), similarly to the inserter 450 shown in FIG. 7. Each impactor 500 a, 500 b can be modular, such that the handle 502, the shaft 504 a, 504 b and/or the coupler 510 can be disassembled for removably mounting the alignment adapter 470 a, 470 b. Additionally, or alternatively, the coupling opening 472 can be a snap-on side opening or side slot for removably receiving the alignment adapter 470 a, 470 b without disassembling the impactor 500 a, 500 b.
In some embodiments, the same alignment adapter can be used for more than one conventional acetabular instrument. For example, the same the alignment adapter 470 (or 470 b) can be used optionally either with the inserter/impactor 450 or the impactor 500 b, or with an acetabular reamer, such as reamer 331.
It will be appreciated from the above discussion, that although the patient-specific acetabular alignment guide 400 has an engagement surface 408 that is complementary to the acetabular/periacetabular area of the patient, the alignment adapters 470, 470 a and 470 b may or may not have a patient-specific engagement surface as they are at a distance away from the bone surface during use. Rather, the location and arrangement of the alignment apertures 478 on the arm 474 is patient-specific, such that the corresponding alignment adapter 470, 470 a, 470 b can be mounted over the plurality of the alignment pins 420 that have been already secured around the acetabulum 82 of the patient using acetabular alignment guide 400.
The acetabular alignment guide 400 and the alignment adapters 470, 470 a, 470 b can be made of disposable polymeric materials or any other biocompatible materials. The alignment adapters 470, 470 a, 470 b can be used with acetabular inserters, positioners, reamers, impactors and other instruments used during the acetabular procedure. The acetabular alignment guide 400 and one or more alignment adapters 470 can be provided in a form of a kit with a set of alignment pins 420. Other reusable, non custom instruments can be also included, for example, an inserter, reamer impactor, etc. The kit can include an acetabular implant 200, which can be custom-made or non custom-made, as approved and selected by the surgeon.
Referring to FIGS. 11A to 12, another patient-specific acetabular guide 400′ is illustrated for use with a reamer 331′. As discussed above in connection with acetabular guides 100 and 400, the acetabular guide 400′, can include a first portion 402′ configured and adapted to be positioned around the rim surface 84 of the acetabulum 82 and a second portion 404′ configured and adapted to be positioned around the periacetabular area of the pelvis 80 of a specific patient. The acetabular alignment guide 400′ can include a three-dimensional curved patient-specific bone engagement surface 408′, which is the underside surface of the first and second portions 402′, 404′ that nestingly mates with the specific patient's anatomy. In the exemplary embodiment illustrated in FIG. 11A, the first portion 402′ can extend around the entire inner rim surface 84 of the acetabulum and at least a portion of the acetabulum 82. Similarly, the second portion 404′ can extend around the entire periacetabular area around the acetabulum 84 when additional stability and attachment area is desired for the particular patient or preferred by the surgeon. The bone engagement surface 408′ can be designed to match complementarily to portions of the acetabular rim surface 84, of the acetabulum 82 and of an adjacent periacetabular area of the pelvis 80 of the patient for close contact/nesting thereon in only one position and orientation. The second portion 404′ of the acetabular alignment guide 400 is also designed during the pre-operative plan to define a plurality of elongated through-slots, apertures or other guiding formations or holes 406′ directed toward the periacetabular area for guiding a plurality of alignment pins 420 parallel to the pre-determined acetabular centering axis CC, as discussed above in connection with FIGS. 5-7. After the alignment pins 620 are secured to the bone, the acetabular guide 400′ can be removed leaving the alignment pins 420 for use with a reamer, as discussed below.
A reamer 331′ or 331″ can be guided by the alignments pins 420, as shown in FIGS. 11B and 12, respectively, along the acetabular centering axis CC. An off-the-shelf or standard (non custom) reamer 331′, 331″ can be used in combination with an adjustable or a patient-specific adapter 470′, 470″. The adapter 470′ can include one or more arms 474′ (two arms 474′ are illustrated in FIG. 11B). Each arm 474′ can be coupled to a shaft 330′ of the reamer 431′ with a quick-coupling arrangement 474′, which can be, for example, an opening in the arms configured for receiving the shaft 330′ or other coupler. Each arm 474′ can include at least one opening 478′ positioned and configured for receiving a corresponding alignment pin 420, which is secured to the bone in a predetermined position and orientation using the patient-specific alignment guide 400′ through a corresponding hole 406 of the guide 400″. Accordingly, the location and orientation of the openings 478′ on the arms 474′ and relative to the acetabular centering axis CC are patient-specific. In some embodiments, an arm 474′ can include more than one opening 478′. The arms 474′ can be integrally attached to one another, or modularly or separately coupled to the shaft 330′. One of the alignment pins, pin 420′ for example, can provide a fixed point of reference for measuring the length of the leg of the patient for determining the length of an implant 200′ and the depth in the corresponding intramedullary canal. The implant 200′ can include a head 203′ and a stem 201′, as shown in FIG. 11C. A scale or other measuring device 477 can be coupled to the pin 420′ for measuring the length and sizing the implant 200′. The scale 477 can be slidably placed over the pin 477′ as shown in FIG. 11B. The length can be measured before implantation and also-post implantation (as shown in FIG. 11B) for confirming proper impaction and placement of the implant.
Referring to FIG. 12, a non-custom reamer 331″ can be coupled with a patient-specific adapter 470″ designed to slide over the alignment pins 420, after the alignment pins 420 are secured on the patient's pelvis 80 in a patient-specific configuration, position and orientation, which also determines the acetabular centering axis CC, as discussed above in connection with FIGS. 5-7. In the embodiment illustrated in FIG. 12, the adapter 470″ can be monolithic and include two arms 474″ for receiving respectively two alignment pins 420 through corresponding openings 478″, although different number of arms 474″ can be used and each arm 474″ can include more than one opening 478″ for receiving more than one pin 420. The adapter 470″ can by coupled to the reamer 331″ with a quick-connect to the shaft of the reamer 331″, as described above in relation to FIGS. 4A-4G, or with another type of connection 335″, such as snap-fit or threadable socket or bayonet coupling. The reamer 331″ can be of the blade type, including reaming blades 333″. In one embodiment, the blades 333″ can be removable, replaceable and/or disposable. Each blade 333″ can be semicircular or quarter-circular and can be attached to a chuck or other support 337″ of the reamer 331″ with set screws or grooves or jaws.
In some procedures, the acetabular implant 200 discussed above can be used to articulate with a patient-specific resurfacing or replacement proximal femoral component, as shown in FIGS. 13, 14A and 14B. For example, a patient-specific resurfacing implant can be designed during the pre-operative plan based on image models reconstructed from scans of the patient.
Referring to FIG. 13, when the femoral head 92 is salvageable and need not be resected and replaced, the diseased or defective surface of the femoral head 92 can be identified in the image. A femoral component 600 can be designed to replace the defective portions, such as poor bone quality and/or avascular regions of the femoral head 92. The femoral component 600 can include a dome-shaped portion or dome 602 with an outer convex articulating surface 603 for articulating with an acetabular implant or the patient's natural acetabulum and an inner bone engagement surface 604 that is designed to match and be complementary and match the surface of the femoral head 92 with or without soft tissue attached, as determined in the pre-operative plan. The dome 602 can have a periphery 608 designed such that the dome covers and resurfaces all the defective portions of the femoral head 92. The femoral component 600 can have a short stem 606, which is inserted through the femoral head 92 and secured into the femoral neck 94. The stem 606 can be designed during the preoperative plan based on the three-dimensional reconstruction of the patient's anatomy from the patient's scans such that the axis of the stem D is placed in a selected position and orientation relative to the neck 94 of the patient's and in a selected anteversion orientation relative to the proximal femur 90. Additionally, the length of the stem 606 and the size and shape of the cross-section 607 along the length of the stem 606 can also be designed based on the preoperative plan and the reconstruction model of the neck 94 of the patient, such that bone preservation and adequate attachment support are balanced and/or optimized for the particular patient.
Referring to FIGS. 14A and 14B, a patient-specific femoral implant 618 for a proximal femur in which the femoral head 92 is resected can include a femoral head component 620, a femoral neck component 624 and a femoral stem component 622. The femoral implant 618 can be designed during the preoperative plan based on the three-dimensional reconstruction of the patient's anatomy from the patient's scans such that the femoral head implant 620 and femoral neck component 624 cooperate to retain the axis D and the center of rotation R of the patient's femur or acetabulum, based on surgeon determination and preference. The femoral neck component 624 can be designed to match the patient's femoral neck 94 in size and orientation. The femoral stem implant 622 can be selected from standard (non custom) stem sizes) or can be customized for length, cross-section and/or shape for the specific patient.
implanting the acetabular implant in the acetabulum with the acetabular inserter, the acetabular inserter holding the acetabular implant.
2. The method of claim 1, wherein guiding a first alignment adapter coupled to an acetabular implant inserter over the alignment pins comprises inserting the alignment pins through complementary apertures of the first alignment adapter.
impacting the acetabular implant with the impactor.
4. The method of claim 3, wherein guiding a second alignment adapter coupled to an impactor over the alignment pins comprises inserting the alignment pins through complementary apertures of the second alignment adapter.
5. The method of claim 4, wherein the first and second alignment adapters are identical.
6. The method of claim 4, wherein the impactor is an offset impactor having a drive shaft offset relative to a center axis of the second alignment adapter and wherein the first and second alignment adapters are different.
implanting the acetabular implant into the acetabulum with the acetabular inserter.
8. The method of claim 7, wherein guiding a first alignment adapter coupled to an acetabular implant inserter over the alignment pins comprises inserting the alignment pins through complementary apertures of the first alignment adapter.
10. The method of claim 9, wherein guiding a second alignment adapter coupled to an impactor over the alignment pins comprises inserting the alignment pins through complementary apertures of the second alignment adapter.
11. The method of claim 9, wherein the first and second alignment adapters are identical.
12. The method of claim 9, wherein the impactor is an offset impactor having a drive shaft offset relative to a center axis of the second alignment adapter and wherein the first and second alignment adapters are different.
13. The method of claim 7, wherein the first alignment adaptor has a patient-specific surface and is slidable relative to the acetabular inserter.
implanting the acetabular implant into the acetabulum by sliding the patient specific alignment adaptor coupled to the acetabular inserter along the alignment pins.
15. The method of claim 14, wherein coupling an acetabular inserter to the patient-specific alignment adaptor comprises passing a shaft of the acetabular inserter through a snap-on side opening of the alignment adapter.
16. The method of claim 14, wherein coupling an acetabular inserter to the patient-specific alignment adaptor comprises removably coupling a shaft of the acetabular inserter to the alignment adapter parallel to the alignment bores of the alignment adapter.
17. The method of claim 14, wherein the alignment adaptor has a patient-specific surface and is slidable relative to the acetabular inserter.
19. The method of claim 18, wherein the impactor has a handle and a shaft offset from the handle.

References: Application No. 61
 Application No. 60
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