US20230414261A1 - Platform fracture fixation implants - Google Patents

Abstract

A proximal portion of an implant for repairing a multipart fracture of a proximal humerus includes an asymmetric body having a proximal end, a distal end, a medial side, a lateral side, an anterior edge, and a posterior edge a medial surface extending along Sat least a portion of the medial side and having a proximal end and a distal end; a protrusion forming the lateral side of the asymmetric body, offset in an anterior direction, and pointing toward a bicipital groove of the humerus when the proximal portion is implanted in the humerus, an anterior support surface configured to support a lesser tuberosity; a posterior support surface configured to support a greater tuberosity; an angled surface having a first side defined by the medial surface, a second side defined by the anterior support surface, and a third side defined by the posterior support surface; and an anchoring point.

Description

FIELD OF THE INVENTION
• The field of invention relates to implants for repair of long bone fractures.
BACKGROUND OF THE INVENTION
• Open reconstruction of long bone fractures presents multiple challenges for the orthopedic surgeon and traumatologist, impacting their ability to reliably treat the traumatic injury. Specifically, variations in patient anatomy, fracture patterns, patient health quality, and patient co-morbidities all influence the quality of fracture reconstruction and also impact the rate and probability of fracture healing over time. As a result of these numerous variables, multiple implant options have been devised for open reduction and internal fixation of long bone fractures, including: intramedullary nails, locking plates, wires, and screws (all of which are provided in kits of numerous sizes and materials). Each implant type is associated with its own features & benefits and also its inherent complication rates for its intended use in different fracture patterns and bones.
• Despite geographic and ethnic uniformity of the types of bone fractures, there exists no clear consensus of treatment method as it relates to implant type. The selection of a particular implant for a given fracture type varies and depends on multiple factors including implant design features, scope, instrumentation, and inherent mechanical integrity provided by the device for a particular fracture type and bone quality.
BRIEF DESCRIPTION OF THE FIGURES
• Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.
• FIG.1 shows fracture lines in a four-part fracture of the proximal humerus.
• FIG.2 shows a first embodiment of a platform fracture fixation implant including a first embodiment of a proximal portion of a platform fracture fixation implant, with fracture lines in a four-part fracture of the proximal humerus shown for reference.
• FIG.3 shows a detailed view of the proximal portion ofFIG.2.
• FIG.4 shows a detailed view of embodiments of various sizes of a distal portion of the platform fracture fixation implant ofFIG.2.
• FIG.5 shows further views of the platform fracture fixation implant ofFIG.2.
• FIG.6 shows further views of the platform fracture fixation implant ofFIG.2 in conjunction with a supplemental humeral head support.
• FIG.7 shows embodiments of various sizes of a second embodiment of a platform fracture fixation implant including a second embodiment of a proximal portion of a platform fracture fixation implant.
• FIG.8 shows a detailed view of embodiments of various sizes of the proximal portion ofFIG.7.
• FIG.9 shows embodiments of various sizes of a third embodiment of a platform fracture fixation implant including a third embodiment of a proximal portion of a platform fracture fixation implant.
• FIG.10 shows a detailed view of embodiments of various sizes of the proximal portion ofFIG.9.
• FIG.11 shows various views of a fourth embodiment of a platform fracture fixation implant including a fourth embodiment of a proximal portion of a platform fracture fixation implant.
• FIG.12 shows a detailed view of the proximal portion ofFIG.11.
• FIG.13 shows various views of a fifth embodiment of a platform fracture fixation implant including a fifth embodiment of a proximal portion of a platform fracture fixation implant, with fracture lines in a four-part fracture of the proximal humerus shown for reference.
• FIG.14 shows a detailed view of the proximal portion ofFIG.13.
• FIG.15 shows various views of a sixth embodiment of a platform fracture fixation implant including a fifth embodiment of a proximal portion of a fracture fixation implant and a locking plate, with fracture lines in a four-part fracture of the proximal humerus shown for reference.
• FIG.16 shows various views of a seventh embodiment of a platform fracture fixation implant including a seventh embodiment of a proximal portion of a fracture fixation implant and an embodiment of a locking plate, with fracture lines in a four-part fracture of the proximal humerus shown for reference.
• FIG.17 shows a detailed view of the proximal portion and locking plate ofFIG.16.
• FIG.18 shows various views of an eighth embodiment of a platform fracture fixation implant including an eighth embodiment of a proximal portion of a platform fracture fixation implant.
• FIG.19 shows a detailed view of embodiments of various sizes and configurations of the proximal portion ofFIG.18.
• FIG.20 shows embodiments of various sizes of a ninth embodiment of a platform fracture fixation implant including a proximal portion that is an adapter suitable for revision as an arthroplasty.
• FIG.21 shows a tenth embodiment of a platform fracture fixation implant that is configured for use to repair a femoral neck fracture.
• FIG.22 shows an eleventh embodiment of a platform fracture fixation implant including an eleventh embodiment of a proximal portion of a platform fracture fixation implant and a humeral head support.
• FIG.23 shows a twelfth embodiment of a platform fracture fixation implant including a twelfth embodiment of a proximal portion of a platform fracture fixation implant and a humeral head support.
SUMMARY OF THE INVENTION
• The exemplary embodiments relate to a trauma system that provides numerous different fracture reconstruction solutions.
• In an embodiment, a proximal portion of an implant for repairing a multipart fracture of a proximal end of a humerus of a human is provided, the proximal portion including an asymmetric body having a proximal end, a distal end opposite the proximal end, a medial side, a lateral side opposite the medial side, an anterior edge, and a posterior edge opposite the anterior edge; a medial surface extending along at least a portion of the medial side, the medial surface having a proximal end and a distal end; a protrusion forming the lateral side of the asymmetric body, the protrusion being offset in an anterior direction, the protrusion extending in a direction so as to point toward a bicipital groove of the humerus when the proximal portion is implanted in the humerus, an anterior support surface defined by an anterior side of the protrusion and extending to the anterior edge of the asymmetric body, the anterior support surface being configured to support a lesser tuberosity of the proximal end of the humerus; a posterior support surface defined by a posterior side of the protrusion and extending to the posterior edge of the asymmetric body, the posterior support surface being configured to support a greater tuberosity of the proximal end of the humerus; a generally triangular angled surface having a first side defined by the proximal end of the medial surface, a second side defined by a proximal end of the anterior support surface, and a third side defined by a proximal end of the posterior support surface; and at least one anchoring point formed in the asymmetric body, the at least one anchoring point configured to engage an anchoring device to thereby anchor the proximal portion to a portion of the humerus.
• In an embodiment, the proximal portion also includes an engagement mechanism positioned at the distal end of the asymmetric body and configured to engage a distal portion of the implant. In an embodiment, the engagement mechanism is a taper. In an embodiment, the proximal portion is integrally formed with a distal portion of the implant.
• In an embodiment, the protrusion includes a fin.
• In an embodiment, the at least one anchoring point includes at least one threaded hole configured to receive at least one screw. In an embodiment, the proximal portion also includes a plurality of suture holes.
• In an embodiment, at least a portion of an outer surface of the proximal portion is porous.
• In an embodiment, the proximal portion also includes a humeral head support engagement point configured to engage a humeral head support. In an embodiment, the angled surface forms the engagement point. In an embodiment, at least one of the anterior support surface and the posterior support surface is concave.
• In an embodiment, a kit for repairing a multipart fracture of a proximal end of a humerus of a human includes a plurality of proximal portions, each of the plurality of proximal portions including: an asymmetric body having a proximal end, a distal end opposite the proximal end, a medial side, a lateral side opposite the medial side, an anterior edge, and a posterior edge opposite the anterior edge; a medial surface extending along at least a portion of the medial side, the medial surface having a proximal end and a distal end; a protrusion forming the lateral side of the asymmetric body, the protrusion being offset in an anterior direction, the protrusion extending in a direction so as to point toward a bicipital groove of the humerus when the proximal portion is implanted in the humerus, an anterior support surface defined by an anterior side of the protrusion and extending to the anterior edge of the asymmetric body, the anterior support surface being configured to support a lesser tuberosity of the proximal end of the humerus; a posterior support surface defined by a posterior side of the protrusion and extending to the posterior edge of the asymmetric body, the posterior support surface being configured to support a greater tuberosity of the proximal end of the humerus; a generally triangular angled surface having a first side defined by the proximal end of the medial surface, a second side defined by a proximal end of the anterior support surface, and a third side defined by a proximal end of the posterior support surface; at least one anchoring point formed in the asymmetric body, the at least one anchoring point configured to engage an anchoring device to thereby anchor the proximal portion to a portion of the humerus; and an engagement mechanism positioned at the distal end of the asymmetric body and configured to engage a distal portion of the implant, wherein each of the proximal portions within the kit is differently sized from all others of the proximal portions within the kit; the kit also including a plurality of distal portions, each of the distal portions having a distal end configured for placement within a medullary cavity of the humerus and a proximal end configured for engagement with the engagement mechanism of a selected one of the plurality of proximal portions, wherein each of the plurality of distal portions within the kit is differently sized from all others of the proximal portions within the kit; and the kit also including at least one humeral head support configured for attachment to the selected one of the plurality of proximal portions, each of the at least one humeral head support including a medial surface, a lateral surface opposite the medial surface of the humeral head support, a proximal end, a distal end opposite the distal end of the humeral head support, and at least one anchoring point configured to engage an anchoring device, wherein the proximal end of each of the at least one humeral head support has a profile that is complementary to the angled surface of the selected one of the proximal portions lateral surface of the humeral head support is positioned adjacent the surface of the proximal portion of the implant, and wherein the lateral surface of the humeral head support is configured to support a humeral head of the humerus during a repair of a four-part fracture of the humerus.
• In an embodiment, each of the plurality of proximal portions has a different size in a proximal-distal direction. In an embodiment, each of the plurality of proximal portions has a different size in an anterior-posterior direction. In an embodiment, each of the plurality of distal portions has a different length or a different diameter from all of the other distal portions within the kit.
• In an embodiment, the engagement mechanism of the plurality of proximal portions includes a taper. In an embodiment, the at least one anchoring point of each of the proximal portions includes at least one threaded hole configured to receive at least one screw. In an embodiment, at least one of the anterior support surface and the posterior support surface of at least one of the proximal portions is concave.
• In an embodiment, a humeral head support for use in an implant for repairing a multipart fracture of a proximal end of a humerus of a human is provided, the humeral head support including a base portion configured for attachment to a proximal end of the implant; and a support portion configured to support a humeral head of the humerus during a repair of a four-part fracture of the humerus.
• In an embodiment, the humeral head support has a medial surface, a lateral surface opposite the medial surface of the humeral head support, a proximal end, a distal end opposite the distal end of the humeral head support, and at least one anchoring point configured to engage an anchoring device, and the base portion configured for attachment to the proximal end of the implant includes the proximal end of the humeral head support having a profile that is complementary to a surface of the proximal portion of the implant when the lateral surface of the humeral head support is positioned adjacent the surface of the proximal portion of the implant.
• In an embodiment, the humeral head support also includes at least one anchoring point. In an embodiment, the at least one anchoring point includes at least one threaded hole configured to receive at least one screw.
DETAILED DESCRIPTION OF THE INVENTION
• Among those benefits and improvements that have been disclosed, other objects and advantages of this invention will become apparent from the following description taken in conjunction with the accompanying figures. Detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely illustrative of the invention that may be embodied in various forms. In addition, each of the examples given in connection with the various embodiments of the invention which are intended to be illustrative, and not restrictive.
• Throughout the specification and claims, the following terms take the meanings explicitly associated herein, unless the context clearly dictates otherwise. The phrases “in one embodiment,” “in an embodiment,” and “in some embodiments” as used herein do not necessarily refer to the same embodiment(s), though it may. Furthermore, the phrases “in another embodiment” and “in some other embodiments” as used herein do not necessarily refer to a different embodiment, although it may. Thus, as described below, various embodiments of the invention may be readily combined, without departing from the scope or spirit of the invention.
• In addition, as used herein, the term “based on” is not exclusive and allows for being based on additional factors not described, unless the context clearly dictates otherwise. In addition, throughout the specification, the meaning of “a,” “an,” and “the” include plural references. The meaning of “in” includes “in” and “on.”
• The exemplary embodiments relate to platform fracture fixation implants (alternately referred to herein as “implants” for brevity) and kits including such implants, which facilitate reconstruction of long bone fractures using multiple different sizes and methods of treatment, in a simpler and more inventory efficient manner. The exemplary embodiments may be suitable for cost sensitive yet anatomically diverse markets served by multiple orthopedic surgeons who may have been trained using various techniques, as the exemplary embodiments can provide many different sizes and options for implant fixation methods. In some embodiments, exemplary implants and kits including exemplary implants may be suitable to address reconstructing fractures of long bones, and more specifically of the humerus. More particularly, the exemplary embodiments illustrated in the accompanying drawings are shown in use reconstructing the proximal humeral head and/or midshaft of the humerus. In other embodiments, implants may be suitable to address reconstructing fractures of other long bones, such as the proximal and distal segments of the femur and tibia, fibula, radius, ulna, clavicle, etc.
• When an orthopedic surgeon or traumatologist attempts to reconstruct a one- or two-part fracture of the proximal humerus, the shoulder joint may be incised with as small an opening as possible in order to protect the rotator cuff and other surrounding musculature from any further damage. However, when an orthopedic surgeon or traumatologist attempts to reconstruct a three- or four-part fracture of the proximal humerus, the shoulder joint may to be opened in order to adequately reconstruct all the bone fragments. Consequently, a surgeon may attempt to reconstruct these different classifications of proximal humeral fractures by different methods. In some embodiments, a platform fracture fixation implant is modular so that it can be pre-assembled on the “back table” as a single unit of appropriate size for a particular patient anatomy or fracture pattern (i.e., so that it can be configured as an intramedullary rod which can be inserted through a small incision for a one- or two-part fracture), or can be assembled in situ by positioning a distal portion with the fracture line (or aligned at the level of the surgical humeral neck) and then positioning a proximal portion, which is shaped to be a scaffold by which it can be used to reconstruct multiple boney fragments (as in a three- or four-part fracture) around the proximal portion.FIG.1 shows the fracture lines of a four-part fracture of the proximal humerus, with a first fracture line extending horizontally along the surgical neck, a second fracture line extending superiorly through the bicipital groove, and a third fracture line extending along the plane of the humeral head at the level of the anatomic neck of the humerus. A four-part fracture is termed as such because these three fracture lines create four parts: (1) the humeral head, (2) the lesser tuberosity, (3) the greater tuberosity, and (4) the humeral shaft.
• In some embodiments, a platform/scaffold is used to affix or co-opt the bone fragments as is traditionally done with hemiarthroplasty, and is used in conjunction with a modular nail. In some embodiments, a proximal portion is noncylindrical and asymmetric in design so that it is provided in left and right sides to respect the different shapes and sizes of the lesser and greater tuberosities of the proximal humerus. Referring now toFIGS.2-6, a first embodiment of a platform fracture fixation implant200 (for brevity, “implant200”) is shown.FIG.2 shows the first embodiment of a platformfracture fixation implant200 from side and top perspectives, with a four-part fracture of the proximal end of a humerus shown for reference in the top right and bottom right.
• In an embodiment, theimplant200 includes an asymmetricproximal portion210 for improved tuberosity reconstruction. In some embodiments, the asymmetricproximal portion210 includes at least one anchoring point262 (e.g., a threaded hole) configured to receive screws or other anchoring elements, thereby to anchor portions of the humerus to the asymmetricproximal portion210. In an embodiment, as shown in the top left and bottom left ofFIG.2, theimplant200 does not include a humeral head support. In an embodiment, as shown in the top center and bottom center ofFIG.2, the implant includes ahumeral head support270. In some embodiments, the modularhumeral head support270 can be attached to theproximal portion210 to provide additional humeral head support.
• In some embodiments, additional humeral head support can help to avoidvaruscollapse in the clinical scenario where the medial calcar is involved/disrupted by the trauma. In some embodiments, screws or other anchoring devices can be secured through or directly to thehumeral head support270 to act as a buttress and strengthen the construct. In an embodiment, theproximal portion210 provides a smaller space for the lesser tuberosity and a larger space for the greater tuberosity. In an embodiment, a protrusion240 (e.g., a fin) is oriented toward the bicipital groove to aid the surgeon in reconstructing the fractured components in the patient's native humeral head retroversion.
• In some embodiments, theimplant200 includes adistal portion290 that is generally cylindrical. In some embodiments, thedistal portion290 is configured as a hollow intramedullary nail (seeFIG.4). In some embodiments, thedistal portion290 is configured as a modular (e.g., cemented or press fit) humeral stem. In some embodiments, thedistal portion290 includes supplemental fixation features along the length of the implant. In some embodiments, thedistal portion290 does not include supplemental fixation features along the length of the implant.
• FIG.3 shows a detailed view of a first embodiment of aproximal portion210 of an implant that is used in theimplant200 ofFIG.2.FIG.3 includes dimensional measurements for various portions of theproximal portion210 shown therein, but it will be apparent to those of skill in the art that these are only exemplary dimensions and that theproximal portion210 ofFIG.3 may be provided in various sizes. In some embodiments, theproximal portion210 includes aproximal end212, adistal end214, amedial side216, alateral side218, ananterior edge220, and a posterior edge222. In some embodiments, theproximal portion210 includes amedial surface230 having aproximal end230 and adistal end232.
• In an embodiment, aproximal portion210 includes an asymmetric body to facilitate tuberosity reconstruction. In an embodiment, ananterior support surface250 is provided for the lesser tuberosity,posterior support surface254 is provided for the greater tuberosity, and theprotrusion240 separates theanterior support surface250 from theposterior support surface254. In some embodiments, theanterior support surface250 has aproximal end252 and theposterior support surface254 has a proximal end256. In such an embodiment, aproximal end210 is therefore provided in left and right sides (with a left sideproximal end210 shown inFIGS.2,3,5, and6. In an embodiment, suture holes264 are included to aid in the bone reattachment. In an embodiment, the asymmetricproximal portion210 is provided in multiple heights to better support the tuberosity sizes for patients of larger or smaller stature or bone size. In an embodiment, the height of theproximal portion210 is 35 mm. In an embodiment, the height of theproximal portion210 is in a range of from 20 to 50 mm. In an embodiment, the asymmetricproximal portion210 is provided in multiple widths. In an embodiment, the width of theproximal portion210 is 15 mm. In an embodiment, the width of theproximal portion210 is in a range of from 10 mm to 40 mm. In an embodiment, the asymmetricproximal portion210 is provided in multiple thicknesses. In an embodiment, the thickness of theproximal portion210 is 12 mm. In an embodiment, the thickness of theproximal portion210 is in a range of from 5 mm to 50 mm. In an embodiment, the radii, positions, and orientations of theprotrusion240 may be differently configured in any of the aforementioned size ranges. In some embodiments, the radii, positions, and orientations of theprotrusion240 may be configured to accommodate a lesser tuberosity that is generally 50% to 80% of the size of the greater tuberosity, and such that theprotrusion240 points to the bicipital groove. In some embodiments, a kit may include various embodiments of the asymmetricproximal portion210 having heights, widths, and depths of varying proportions with respect to one another in order to provide for the anatomical variations of different patients. In some embodiments, adistal end214 of theproximal portion210 is provided with a male taper266 (i.e., an engagement mechanism). In some embodiments, themale taper266 has a diameter of 10 mm. In some embodiments, themale taper266 has a diameter in a range of from 7 mm to 14 mm. In some embodiments, a size of thedistal end214 of thedistal portion210 may vary based on a size of theproximal portion210 and/or a size of theimplant200 as a whole. In some embodiments, thedistal end214 of theproximal portion210 may be provided with another suitable type of engagement mechanism for engaging thedistal portion290.
• In an embodiment, the asymmetricproximal portion210 may include the humeral head support device270 (seeFIG.2, top center and bottom center). In some embodiments, the humeralhead support device270 includes aproximal end272, adistal end274, amedial surface276, alateral surface278, ananterior side280, and aposterior side282. In an embodiment, the humeralhead support device270 may be provided in multiple lengths. In an embodiment, the length of the humeralhead support device270 is 40 mm. In an embodiment, the length of the humeralhead support device270 is in a range of from 10 mm to 60 mm. In an embodiment, the humeralhead support device270 is provided in multiple widths. In an embodiment, the width of the humeralhead support device270 is 11 mm. In an embodiment, the width of thehumeral head support270 is in a range of from 5 mm to 35 mm.FIG.3 includes dimensional measurements embodiments of for various portions of various dimensions of the humeralhead support device270, but it will be apparent to those of skill in the art that these are only exemplary dimensions and that the humeralhead support device270 ofFIG.3 may be provided in various sizes or shapes and also connected to the proximal portion of a humeral nail of various sizes or shapes. For example, the humeral head support device can be adapted to connect to the proximal portion of a traditional cylindrical nail. In some embodiments, theproximal portion210 includes a substantial triangularangled surface260 configured to engage the humeral head support device. In some embodiments, theangled surface260 extends from the proximal end of232 of themedial surface230 and is defined by theproximal end232 of themedial surface230, theproximal end252 of the anteriorconcave surface250, and the proximal end256 of the posteriorconcave surface254. In some embodiments, a profile of a portion of thehumeral head support270 adjacent theproximal end272 thereof is complementary to a profile to theangled surface260 of theproximal portion210.
• FIG.4 shows a detailed view of a first embodiment of adistal portion290 of animplant200 that is used in theimplant200 ofFIG.2.FIG.4 includes dimensional measurements embodiments of for various portions of various sizes of thedistal portion290 shown therein, but it will be apparent to those of skill in the art that these are only exemplary dimensions and that thedistal portion290 ofFIG.4 may be provided in various sizes.
• In some embodiments, thedistal portion290 includes locking talons292 (i.e., supplemental fixation features) for distal fixation without the need for diaphsyeal locking screws. In some embodiments, thedistal portion290 is a stem (as with a hemiarthroplasty). In some embodiments, thedistal portion290 is a cylindrical or other-shaped (i.e., cross-sectionally shaped) shaft (as with an intramedullary nail). In some embodiments, a diameter of thedistal portion290 is a range of from 7.5 mm to 9 mm. In some embodiments, a diameter of thedistal portion290 is a range of from 7.5 mm to 20 mm. In some embodiments, a length of thedistal portion290 is 80 mm. In some embodiments, a length of thedistal portion290 is in a range of from 40 mm to 260 mm. In some embodiments, aproximal end294 of thedistal portion290 is provided with afemale taper296 that is configured to engage themale taper266 of theproximal portion210. In some embodiments, thefemale taper296 has a diameter of 10 mm. In some embodiments, thefemale taper296 has a diameter in a range of from 7 mm to 14 mm. In some embodiments, a size of theproximal end294 of thedistal portion290 may vary based on a size of thedistal portion290 and/or a size of theimplant200 as a whole. In some embodiments, theproximal end294 of thedistal portion290 may be provided with another suitable type of engagement mechanism for engaging theproximal portion210.
• FIG.5 shows additional views of the implant ofFIG.2.FIG.5 includes dimensional measurements for various portions of the implant shown therein, but it will be apparent to those of skill in the art that these are only exemplary dimensions and that the implant ofFIG.5 may be provided in various sizes. In some embodiments, an implant includes an asymmetric proximal portion for improved tuberosity reconstruction.
• In some embodiments, as shown inFIG.5, animplant200 does not include a supplementalhumeral head support270.FIG.6 shows additional views of theimplant200 ofFIG.2.FIG.6 includes dimensional measurements for various portions of theimplant200 shown therein, but it will be apparent to those of skill in the art that these are only exemplary dimensions and that theimplant200 ofFIG.6 may be provided in various sizes. In some embodiments, animplant200 includes an asymmetric proximal portion for improved tuberosity reconstruction. In some embodiments, as shown inFIG.5, an implant includes a supplementalhumeral head support270.
• In some embodiments, as shown inFIGS.2-6, animplant200 includes a proximal210 portion providing a smaller surface/space (e.g., anterior support surface250) for the lesser tuberosity and a larger surface/space (e.g., posterior support surface254) for the greater tuberosity. In some embodiments, a surgeon will need to reconstruct the bone fragments in a manner that respects the patient's original anatomy. In some embodiments, to accomplish this, the surgeon will orient the humeral head fracture according to the patients humeral head retroversion. In some embodiments, to aid in such orientation when performed in situ, theprotrusion240, which separates the lesser and greater tuberosity beds, is oriented toward the bicipital groove (which is a common fracture location involved in the fracture classification and an anatomic landmark commonly utilized/referenced for reconstructions to recreate the patients anatomic humeral head retroversion).
• In some embodiments, platform fracture fixation implants, proximal portions of platform fracture fixation implants, and distal portions of platform fracture fixation implants can be provided in different lengths, widths, thicknesses and at different aspect ratios in order to best fill the proximal humeral defect and function as a scaffold to reconstruct the components around. It will be known to those of skill in the art that the proximal humerus anatomy is highly variable. Therefore, in some embodiments, implants are provided in different sizes such that the proximal portions thereof are provided in a patient-size specific manner, which would thereby better configure the position of the screws for the patient's fracture.
• In some embodiments, a modular platform fracture fixation implant kit may include may include differing embodiments of proximal portions and/or distal portions.FIG.7 shows a second embodiment of a platformfracture fixation implant700. In the embodiment ofFIG.7, animplant700 includes an intramedullary nail that utilizes multiple locking screws in differently-sizedproximal segments710,712,714 to ensure anatomically-correct screw positions through the bone fragments for various sizes of humeral anatomies. In some embodiments, the intramedullary nail ofFIG.7 may also be adapted to accept the humeralhead support piece270 depicted inFIGS.2,3, and6.FIG.8 shows embodiments of various sizes of a second embodiment of a proximal portion that may form the proximal portion of the implant ofFIG.7 (e.g., asmall size710, amedium size712, and a large size714).FIG.8 includes dimensional measurements for various portions of the variously sized embodiments of the proximal portion shown therein, but it will be apparent to those of skill in the art that these are only exemplary dimensions and that the proximal portion ofFIG.8 may be provided in various sizes. In some embodiments, theimplant700 ofFIG.7 including the proximal portion ofFIG.8 facilitates in situ reconstruction of proximal humeral fractures and provides for improved tuberosity reconstruction, while accounting for various humeral head sizes and anatomic variations.
• In some embodiments, a cephlalomedullary style of proximal portion is utilized in multiple sizes in order to position a larger lag screw in the center of the humeral head (or some other desired location), despite significant anatomic variation in humeral head size, humeral head diameter, and humeral head medial/lateral and anterior/posterior offset relative to the intramedullary canal.FIG.9 shows a third embodiment of a platformfracture fixation implant900 including a cephlalomedullary style ofproximal portion910,912,914. More particularly,FIG.9 shows multiple views of a third embodiment of platform fracture fixation implant, showing multiple sizes of a proximal portion (e.g., asmall size910, amedium size912, a large size914) of a straight nail with a lag screw to facilitate insertion of the lag screw in the center of the humeral head (accounting for various humeral head sizes) when reconstructing proximal humeral fractures.FIG.10 shows embodiments of various sizes of a third embodiment of aproximal portion910,912,914 that may form the proximal portion of theimplant900 ofFIG.9.FIG.10 includes dimensional measurements for various portions of the variously sized embodiments of the proximal portion shown therein, but it will be apparent to those of skill in the art that these are only exemplary dimensions and that the proximal portion ofFIG.10 may be provided in various sizes. In some embodiments, the proximal portions ofFIG.10 provide various sizes of animplant900 that is a straight nail with a lag screw, to facilitate insertion of the lag screw in the center of the humeral head (accounting for various humeral head sizes) when reconstructing proximal humeral fractures.
• FIG.11 shows a fourth embodiment of a platformfracture fixation implant1100 including a cephlalomedullary style ofproximal portion1110. More particularly,FIG.11 shows multiple views of a third embodiment of a platform fracture fixation implant, showing multiple views of a proximal portion that is asymmetric in shape to provide a more rotationally stable reconstruction than the traditional cylinder. In the embodiment ofFIG.11, the extensions of the proximal portion in the directions of both the lesser and greater tuberosities provide for better distribution of screws within the fractured bone to prevent a stress concentration and provide more compression to the fragments.FIG.12 shows multiple views of a fourth embodiment of aproximal portion1110 that may form the proximal portion of the implant ofFIG.11. In some embodiments, theproximal portion1110 includes aproximal end1112, adistal end1114, amedial side1116, a lateral side1118, ananterior end1120, and aposterior end1122.FIG.12 includes dimensional measurements for various portions of theproximal portion1110 shown therein, but it will be apparent to those of skill in the art that these are only exemplary dimensions and that theproximal portion1110 ofFIG.12 may be provided in various sizes. As noted above, the cephlalomedullaryproximal portion1110 ofFIG.12 is asymmetric and is therefore more rotationally stable than a cylinder for improved tuberosity reconstruction.
• In the embodiment ofFIG.12, thelocations1162 for attachment of the screws are distributed across theproximal portion1110 and suture holes1164 are provided to aid in the bone reattachment. In the embodiment ofFIG.12, aproximal portion1110 has a height of 25 mm and a width of 27 mm. In some embodiments, aproximal portion1110 has a height in a range of from 5 mm to 45 mm and a width in a range of from 7 mm to 47 mm. In some embodiments, varying sizes of aproximal portion1110 may account for patients' differently-sized humeral heads, as depicted for the aforementioned cephlalomedullary design, thereby ensuring that the central lag screw is positioned in the center of the humeral head regardless of the patient's humeral head size (i.e., diameter and/or thickness) or the patient's humeral head offset (i.e., medial/lateral or anterior/posterior) relative to the intramedullary axis.
• FIG.13 shows a fifth embodiment of a platformfracture fixation implant1300 including a cephlalomedullary style ofproximal portion1310. More particularly,FIG.13 shows multiple views of a third embodiment of a platformfracture fixation implant1300, showing multiple sizes of aproximal portion1310 that is asymmetric in shape to provide a more rotationally stable reconstruction than the traditional cylinder. In the embodiment ofFIG.13, amedial support1370 is integrated into the proximal portion to provide improved humeral head support in the case of medial calcar disruption. Similar to the embodiment ofFIGS.11 and12, in the embodiment ofFIG.13,locations1362 for screw attachment are spread from the central axis in order to better distribute the screws through the fractured tuberosities into the humeral head while maintaining a large central lag screw. A four-part fracture of the proximal humerus is shown for reference to the top left.
• FIG.14 shows multiple views of a fifth embodiment of aproximal portion1362 that may form the proximal portion of the implant ofFIG.13. In some embodiments, theproximal portion1310 includes aproximal end1312, adistal end1314, amedial side1316, alateral side1318, an anterior end1320, and aposterior end1322. As noted above, the cephlalomedullary proximal portion ofFIG.14 is asymmetric and is therefore more rotationally stable than a cylinder for improved tuberosity reconstruction. Thelocations1362 for attachment of the screws are distributed throughout the proximal portion andsuture holes1364 are provided to aid in the bone reattachment. Theproximal portion1310 ofFIG.14 includes amedial support1370 to provide improved humeral head support in the case of medial calcar disruption.
• In some embodiments, a proximal humeral nail and a locking plate are used in conjunction with one another. Such embodiments may be suitable for use to repair severe and multipart comminuted fractures. In some embodiments of a modular platform fracture fixation implant, this combination can be accomplished by providing multiple sizes of a proximal nail portion in any of the aforementioned configurations while ensuring the central lag is centered in the humeral head, with the plate positioned ideally on the lateral humerus, and achieving a sufficient distribution of screws into the fractured bone.FIG.15 illustrates various views of a sixth embodiment of a platformfracture fixation implant1500 having aproximal portion1510, which is combined with alocking plate1511. A four-part fracture of the proximal humerus is shown on the right for reference. In the embodiment ofFIG.15, the locations for screw attachment are spread from the central axis in order to better distribute the screws through the fractured tuberosities into the humeral head while maintaining a large central lag screw and positioning the plate on the lateral proximal humerus bone for added stability in multipart fractures. In some embodiments, the screws that attach the locking plate may also lock into the intramedullary nail for added construct stiffness.
• In some embodiments, the distal end of a locking plate is configured to include a modular connection to the proximal end of the distal nail, for construction of a hybrid nail plate (with or without a proximal nail component).FIG.16 illustrates various views of a seventh embodiment of a platformfracture fixation implant1600, which has a taper connection between alocking plate1610 and adistal nail1690. A four-part fracture of the proximal humerus is shown for reference on the left. In the embodiment ofFIG.16, the locations for screw attachment are spread from the central axis in order to better distribute the screws through the fractured tuberosities into the humeral head while maintaining a distal platform segment for added rotational stability and bending resistance. In the embodiment ofFIG.16, a central lag screw is included.
• FIG.17 illustrates various views of an embodiment of alocking plate1610 that forms a portion of the implant ofFIG.16, and may be referred to as a seventh embodiment of a proximal portion of a platformfracture fixation implant1600. In the embodiment ofFIG.17, alateral locking plate1610 includes a modular connection for securing to the distal portion of platformfracture fixation implant1600. In the embodiment ofFIG.17, a central lag screw (not shown) may be included or may be omitted. In some embodiments, a taper connection is modularly connected to the locking plate, to improve manufacturability and to enable use without the taper if so desired as a stand-alone locking plate.
• For mid-shaft fractures or one- or two-part fractures of the proximal humerus, surgeons may wish to insert a nail through a small incision on the superior humeral head.FIG.18 illustrates various views of an eighth embodiment of a platformfracture fixation implant1800, which may be suitable for such techniques.FIG.18 includes dimensions for various portions of the platformfracture fixation implant1800 shown therein, but those of skill in the art will understand that these dimensions are only exemplary and that the platform fracture fixation implant ofFIG.18 may be provided in a variety of sizes. In the embodiment, ofFIG.18, a platform fracture fixation implant is in the form of a curved nail. In some embodiments, an implant is back-table pre-assembled. In some embodiments, an appropriately-sized proximal portion is selected from a kit, and has a bend adapted to facilitate insertion while minimizing damage to a patient's rotator cuff or surrounding musculature.
• FIG.19 shows embodiments of various sizes of an eighth embodiment of a proximal portion (e.g., a small size1810, amedium size1902, alarge size1904, and a high-angle large size1906) that may form the proximal portion of theimplant1800 ofFIG.18.FIG.19 includes dimensional measurements for various portions of the variously sized embodiments of the proximal portion shown therein, but it will be apparent to those of skill in the art that these are only exemplary dimensions and that the proximal portion ofFIG.19 may be provided in various sizes. In some embodiments, the angled bend of the proximal portion ofFIG.19 may vary to account for various humerus sizes and anatomic variations. In the embodiments shown inFIG.19, an angled bend may vary in a range of from an angle of 6° to an angle of 12°. In some embodiments, an angled bend may vary in a range of from an angle of 0° to an angle of 20°.
• In some embodiments, a kit provides for revision scenarios. Arthroplasty is commonly used as the revision should a fracture fail to heal.FIG.20 shows an adapter providing the ability to convert a failed fracture reconstruction to a shoulder arthroplasty2000 (e.g., a hemi arthroplasty, a total shoulder arthroplasty, or a reverse total shoulder arthroplasty) using a taper and screw connection, or other similar connecting means. More particularly,FIG.20 shows a modular taper adapter (adapter shown detached to the left) in a variety of sizes (e.g., a small size2002, amedium size2004, and a large size2006) that may enable the conversion of a platform fracture fixation implant to a hemi arthroplasty, a total shoulder arthroplasty, or a reverse total shoulder arthroplasty, all of which could be secured to the proximal portion of the adapter ofFIG.20. InFIG.20, an adapter is shown as connected to various sizes of a prosthesis sold under the trademark EQUINOXE by Exactech, Inc. of Gainesville, Florida.
• In some embodiments, the various modular proximal and distal portions of platform fracture fixation implants described above may be provided in different shape variations than those described herein. In some embodiments, talon-like fixation units may be used to gain bony purchase of the fragments or shaft of the long bone. In some embodiments, bone screws may be used. In some embodiments, the modular segments of platform fracture fixation implants (i.e., various proximal and distal portions) may be affixed or keyed to one other by various methods including taper locking, threaded sections, or slide and cross pinned connection to allow various rotational orientations. In some embodiments, screw connections can be threaded or be slip fit, as appropriate. In some embodiments, any of the concepts embodied by the various modular proximal and distal portions of platform fracture fixation implants describe above may be applied to other long bones (e.g., the proximal and distal segments of the femur, tibia, fibula, radius, ulna, clavicle, etc.).FIG.21 shows only one such variation, in which animplant2100, including aproximal portion2110 and a distal portion2190, is adapted to be positioned in the proximal femur in order to reconstruct a femoral neck fracture.
• FIG.22 illustrates various views of a eleventh exemplary embodiment of a platform fracture fixation implant2200. In some embodiments, the platform fracture fixation implant2200 includes aproximal portion2210 and adistal portion2290. In some embodiments, theproximal portion2210 includes at least one anchoring point2262 (e.g., a threaded hole) configured to receive screws or other anchoring elements, thereby to anchor portions of the humerus to the asymmetricproximal portion2210. In some embodiments, theproximal portion2210 includes aprotrusion2240 that is configured so as to extend toward the bicipital groove when the implant2200 is implanted in the humerus of a patient. In some embodiments, theproximal portion2210 includes aproximal end2212, adistal end2214, amedial side2216, alateral side2218, ananterior end2220, and aposterior end2222. In some embodiments, theproximal portion2210 includes a humeral headsupport engagement point2260 at theproximal end2212. In some embodiments, the humeral headsupport engagement point2260 is substantially cylindrical. In some embodiments, the implant2200 includes ahumeral head support2270. In some embodiments, thehumeral head support2270 is configured to be mounted to the humeral headsupport engagement point2260 of theproximal portion2210.
• FIG.23 illustrates various views of a twelfth exemplary embodiment of a platform fracture fixation implant2300. In some embodiments, the platform fracture fixation implant2300 includes aproximal portion2310 and adistal portion2390. In some embodiments, theproximal portion2310 includes at least one anchoring point2362 (e.g., a threaded hole) configured to receive screws or other anchoring elements, thereby to anchor portions of the humerus to the asymmetricproximal portion2310. In some embodiments, theproximal portion2310 includes aproximal end2312 and adistal end2314. In some embodiments, theproximal portion2310 includes a humeral headsupport engagement point2360 at theproximal end2312. In some embodiments, the humeral headsupport engagement point2360 is substantially cylindrical. In some embodiments, the implant2300 includes ahumeral head support2370. In some embodiments, thehumeral head support2370 is configured to be mounted to the humeral headsupport engagement point2360 of theproximal portion2310. In some embodiments, the humeral headsupport engagement point2360 includes a cylindrical portion with internal threading, and the implant2300 includes ascrew2384 configured to mount thehumeral head support2370 to the humeral headsupport engagement point2360.
• In some embodiments, the various modular proximal and distal portions of platform fracture fixation implants described above may be manufactured from various different biocompatible materials, including, but not limited to, cobalt-chrome, stainless steel, titanium, titanium alloys, carbon fiber reinforced polymers, ceramic, poly(methyl methacrylate) (“PMMA”) bone cement, pyrocarbon, bone graft, and/or any other suitable biocompatible material. In some embodiments, the various modular proximal and distal portions of platform fracture fixation implants described above may be fabricated by traditional computer added manufacturing processes, by using additive manufacturing or similar processes, or by any other suitable manufacturing process. In some embodiments, the various modular proximal and distal portions of platform fracture fixation implants described above may be surface coated or treated with various processes to encourage fixation to the soft tissue, muscle, and/or bone. In some embodiments, the various modular proximal and distal portions of platform fracture fixation implants described above may be porous over some or all of their surfaces so as to encourage bone ingrowth therein, and thereby encourage fixation to the bone.
• While a number of embodiments of the present invention have been described, it is understood that these embodiments are illustrative only, and not restrictive, and that many modifications may become apparent to those of ordinary skill in the art. For example, all dimensions discussed herein are provided as examples only, and are intended to be illustrative and not restrictive. Further, any desired number and shape of screw hole(s), suture hole (s), etc. may be utilized (and may be placed in any desired location(s) on the prosthesis). Further still, while the term “fin” has been used throughout this application and may be thought to imply a separate, stand-alone feature, it is to be understood that the invention may, of course, utilize one or more surfaces of an essentially continuous structure in addition to (or in place of) a “fin”.

Claims (18)

1.-18. (canceled)

19. A humeral head support for use in an implant for repairing a multipart fracture of a proximal end of a humerus of a human, the humeral head support comprising:

a base portion configured for attachment to a proximal end of the implant; and

a support portion configured to support a humeral head of the humerus during a repair of a four-part fracture of the humerus,

wherein the support portion extends from the base portion in a direction such that the base portion is configured to extend from the base portion diagonally in a medial and distal direction when the base portion is attached to the proximal end of the implant and when the implant is implanted so as to be surrounded by bone within a proximal volume of the humerus, and

wherein the support portion is positioned with respect to the base portion so as to be positioned between the humeral head of the humerus and a lesser tuberosity of the humerus so as to support the humeral head of the humerus when the implant is implanted so as to be surrounded by bone during a repair of a four-part fracture of the humerus.

20. The humeral head support ofclaim 19,

wherein the humeral head support has a medial surface, a lateral surface opposite the medial surface of the humeral head support, a proximal end, a distal end opposite the distal end of the humeral head support, and at least one anchoring point configured to engage an anchoring device, and

wherein the base portion configured for attachment to the proximal end of the implant includes the proximal end of the humeral head support having a profile that is complementary to a surface of the proximal portion of the implant when the lateral surface of the humeral head support is positioned adjacent the surface of the proximal portion of the implant.

21. The humeral head support ofclaim 19, further comprising at least one anchoring point.

22. The humeral head support ofclaim 21, wherein the at least one anchoring point includes at least one threaded hole configured to receive at least one screw.

23. The humeral head support ofclaim 19, wherein the humeral head support has a length that is in a range of from 10 millimeters to 60 millimeters.

24. The humeral head support ofclaim 19, wherein the humeral head support has a width that is in a range of from 5 millimeters to 35 millimeters.

25. The humeral head support ofclaim 19, wherein the base portion is configured to be coupled to a triangular surface of the proximal end of the implant.

26. The humeral head support ofclaim 19, wherein the base portion is configured to be coupled to a cylindrical intramedullary nail.

27. A kit, comprising:

a plurality of humeral head supports configured for use in an implant for repairing a multipart fracture of a proximal end of a humerus of a human, wherein each humeral head support of the plurality of humeral head supports comprises:

a base portion configured for attachment to a proximal end of the implant; and

a support portion configured to support a humeral head of the humerus during a repair of a four-part fracture of the humerus,

wherein the support portion extends from the base portion in a direction such that the base portion is configured to extend from the base portion diagonally in a medial and distal direction when the base portion is attached to the proximal end of the implant and when the implant is implanted so as to be surrounded by bone within a proximal volume of the humerus, and

wherein the support portion is positioned with respect to the base portion so as to be positioned between the humeral head of the humerus and a lesser tuberosity of the humerus so as to support the humeral head of the humerus when the implant is implanted so as to be surrounded by bone during a repair of a four-part fracture of the humerus.

28. The kit ofclaim 27, wherein a first humeral head support of the plurality of humeral head supports and a second humeral head support of the plurality of humeral head supports are shaped differently from one another.

29. The kit ofclaim 28, wherein the base portion of the first humeral head support is configured to be coupled to a triangular surface of the proximal end of the implant, and wherein the base portion of the second humeral head support is configured to be coupled to a cylindrical intramedullary nail.

30. The kit ofclaim 27, wherein a first humeral head support of the plurality of humeral head supports and a second humeral head support of the plurality of humeral head supports are sized differently from one another.

31. The kit ofclaim 30, wherein the first humeral head support and the second humeral head support have different lengths from one another.

32. The kit ofclaim 30, wherein the first humeral head support and the second humeral head support have different widths from one another.

33. The kit ofclaim 30,

wherein each humeral head support of the plurality of humeral head supports has a medial surface, a lateral surface opposite the medial surface of the humeral head support, a proximal end, a distal end opposite the distal end of the humeral head support, and at least one anchoring point configured to engage an anchoring device, and

wherein the base portion of each humeral head support of the plurality of humeral head supports configured for attachment to the proximal end of the implant includes the proximal end of the humeral head support having a profile that is complementary to a surface of the proximal portion of the implant when the lateral surface of the humeral head support is positioned adjacent the surface of the proximal portion of the implant.

34. The kit ofclaim 30, wherein at least one humeral head support of the plurality of humeral head supports further comprises at least one anchoring point.

35. The kit ofclaim 34, wherein the at least one anchoring point includes at least one threaded hole configured to receive at least one screw.

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