ORTHOPEDIC PLATE FOR TREATMENT OF TIBIAL FRACTURES AND RELATED METHODS

An orthopedic tension band plate includes proximal and distal portions. The proximal portion includes a first proximal aperture configured to receive a first securing member, and a second proximal aperture disposed distal of the first proximal aperture and configured to receive a second securing member. The distal portion includes first and second tines extending distally to first and second distal ends having first and second distal apertures configured to receive third and fourth securing members. At least the first and second tines are configured to wrap around and conform to portions of the bone proximate to the fracture and, thereby, convert tensile forces at the fracture into compressive forces when the first through fourth securing members are secured through their respective apertures and into the bone.

FIELD

The present disclosure relates to implants and/or systems for treatment of bone fractures and related methods.

BACKGROUND

Different types of loads cause different types of bone fracture patterns. For example, axial loads can cause an avulsion fracture pattern, where a piece of the bone attached to a ligament or tendon is pulled away. This fracture pattern has both compressive and tensile forces acting upon the fracture. In this instance, the tensile forces are present but compressive forces between the bone fragments are no longer sufficient, causing gaps. To close these gaps between bone fragments, the tensile forces on the bone fracture must be converted into compression forces.

The most familiar technique, called tension band-wiring, converts the tensile forces into compression forces by inserting two K-wires across the fracture site and on the tension side of the bone, inserting a cancellous screw into the long bone, and wrapping gauge wire in a figure of eight motion around the head of the screw and the K-wires. The gauge wire is then twisted and pulled to compress the fracture site. This tension band-wiring technique has many disadvantages including, but not limited to, K-wire migration, constructure failure, implant irritation, prominent implants, and common occurrence of implant removal.

Another technique to convert the tensile forces of a bone fracture into compression forces uses two cancellous screws, inserted perpendicular to the fracture site. The main advantage of this technique is the screws can back out of the bone, therefore allowing discontinuation of conversion of the tensile forces into compression forces. However, this can cause gapping of the fracture fragments to recur, requiring a revision surgery to fixate the fracture. Another disadvantage to this technique is the requirement for adequate bone purchase by the screws, which may be difficult if the patient has osteoporotic bone. In addition, the fracture must be fully reduced before implantation, otherwise gapping will occur in the bone fragments and mechanical stability of the fracture will be compromised.

Accordingly, a need exists for new implants and/or systems for treatment of bone fractures, and related methods, that allow for conversion of tensile forces into compressive forces within and/or between various surfaces of a bone fracture while overcoming at least the disadvantages of the tension band-wiring and dual cancellous screw techniques.

SUMMARY

In some embodiments, an orthopedic tension band plate for treatment of a fracture in a bone is provided. The plate includes a proximal portion configured to be disposed against a portion of the bone proximal of the fracture, and a distal portion configured to be disposed against at least a portion of the bone distal of the fracture. The proximal portion includes a first proximal aperture configured to receive a first securing member, and a second proximal aperture disposed distal of the first proximal aperture and configured to receive a second securing member. The distal portion includes a first tine extending distally to a first distal end including a first distal aperture configured to receive a third securing member, and a second tine extending distally to a second distal end including a second distal aperture configured to receive a fourth securing member. At least the first and second tines are configured to wrap around and conform to portions of the bone proximate to the fracture and, thereby, convert tensile forces at the fracture into compressive forces when the third and fourth securing members are driven through the respective first and second distal apertures, into the bone distal of the fracture, the second securing member is secured through the second proximal aperture and into the bone proximal of the fracture, and the first securing member is secured through the first proximal aperture and into the bone proximal of the fracture and proximal of the second securing member.

In some embodiments, a method of utilizing an orthopedic tension band plate for treatment of a fracture in a bone is provided. The method includes disposing at least a portion of the tension band plate proximate to the fracture and against the bone. The tension band plate includes a proximal portion and a distal portion. The proximal portion includes a first proximal aperture configured to receive a first securing member, and a second proximal aperture disposed distal of the first proximal aperture and configured to receive a second securing member. The distal portion includes a first tine extending distally to a first distal end including a first distal aperture configured to receive a third securing member, and a second tine extending distally to a second distal end including a second distal aperture configured to receive a fourth securing member. The method includes driving the third and fourth screws through the respective first and second distal apertures, into the bone distal of the fracture, and perpendicular to and through a plane of the fracture. The method includes driving the first securing member through the first proximal aperture and into the bone proximal of the fracture, thereby causing at least the first and second tines to wrap around and conform to portions of the bone proximate to the fracture, pulling the proximal portion into contact with a portion of the bone proximal of the fracture, and converting tensile forces at the fracture into compressive forces.

In some embodiments, a method of manufacturing an orthopedic tension band plate for treatment of a fracture in a bone is provided. The method includes forming a proximal portion of the tension band plate with a configuration for disposal against a portion of the bone proximal of the fracture at least in that the proximal portion includes a first proximal aperture configured to receive a first securing member, and a second proximal aperture disposed distal of the first proximal aperture and configured to receive a second securing member. The method includes forming a distal portion of the tension band plate with a configuration for disposal against at least a portion of the bone distal of the fracture at least in that the distal portion includes a first tine extending distally to a first distal end including a first distal aperture configured to receive a third securing member, and a second tine extending distally to a second distal end including a second distal aperture configured to receive a fourth securing member. At least the first and second tines are formed with a configuration for wrapping around and conforming to portions of the bone proximate to the fracture and, thereby, a configuration for converting tensile forces at the fracture into compressive forces the third and fourth securing members are secured through the respective first and second distal apertures, into the bone distal of the fracture, the second securing member is secured through the second proximal aperture and into the bone proximal of the fracture, and the first securing member is secured through the first proximal aperture and into the bone proximal of the fracture and proximal of the second securing member.

In some other embodiments, another orthopedic tension band plate for treatment of a fracture in a bone is provided. The plate includes a medial portion comprising an aperture, a proximal portion integrally coupled to one side of the medial portion and a distal portion integrally coupled to an opposite side of the medial portion from the proximal portion. The proximal portion is configured to be disposed against a portion of the bone proximal of the fracture and the distal portion configured to be disposed against at least a portion of the bone distal of the fracture. The distal portion includes a first tine extending distally to a first distal end including a first distal aperture configured to receive a third securing member, and a second tine extending distally to a second distal end including a second distal aperture configured to receive a fourth securing member. The proximal portion includes a first tine extending proximally to a first proximal end including a first proximal aperture configured to receive a third securing member, and a second tine extending proximally to a second proximal end including a second proximal aperture configured to receive a fourth securing member. At least the first and second distal tines are configured to wrap around and conform to portions of the bone proximate to the fracture and, thereby, convert tensile forces at the fracture into compressive forces when the third and fourth securing members are driven through the respective first and second distal apertures, into the bone distal of the fracture, and the first and second securing members are secured through the first and second proximal apertures and into the bone proximal of the fracture.

In some other embodiments, another method of utilizing an orthopedic tension band plate for treatment of a fracture in a bone is provided. The method includes disposing at least a portion of the tension band plate proximate to the fracture and against the bone. The tension band plate includes a medial portion, a proximal portion and a distal portion. The plate includes a medial portion comprising an aperture, a proximal portion integrally coupled to one side of the medial portion and a distal portion integrally coupled to an opposite side of the medial portion from the proximal portion. The proximal portion is configured to be disposed against a portion of the bone proximal of the fracture and the distal portion configured to be disposed against at least a portion of the bone distal of the fracture. The distal portion includes a first tine extending distally to a first distal end including a first distal aperture configured to receive a third securing member, and a second tine extending distally to a second distal end including a second distal aperture configured to receive a fourth securing member. The proximal portion includes a first tine extending proximally to a first proximal end including a first proximal aperture configured to receive a third securing member, and a second tine extending proximally to a second proximal end including a second proximal aperture configured to receive a fourth securing member. At least the first and second distal tines are configured to wrap around and conform to portions of the bone proximate to the fracture and, thereby, convert tensile forces at the fracture into compressive forces when the third and fourth securing members are driven through the respective first and second distal apertures, into the bone distal of the fracture, and the first and second securing members are secured through the first and second proximal apertures and into the bone proximal of the fracture. The method includes driving the third and fourth securing members through the respective first and second distal apertures, into the bone distal of the fracture, and perpendicular to and through a plane of the fracture. The method includes driving the first and second securing members through the respective first and second distal apertures, into the bone distal of the fracture, thereby causing at least the first and second tines of the distal portion to wrap around and conform to portions of the bone proximate to the fracture, pulling the proximal portion into contact with a portion of the bone proximal of the fracture, and converting tensile forces at the fracture into compressive forces.

In some embodiments, a method of manufacturing an orthopedic tension band plate for treatment of a fracture in a bone is provided. The method includes forming a medial portion comprising an aperture and integrally forming a proximal portion with a configuration for disposal against a portion of the bone proximal of the fracture, The proximal portion comprises a first proximal tine extending distally to a first proximal end comprising a first proximal aperture configured to receive a first securing member, and a second proximal tine extending proximally to a second proximal end comprising a second proximal aperture configured to receive a second securing member. The method includes integrally forming the distal portion of the tension band plate with a configuration for disposal against at least a portion of the bone distal of the fracture at least in that the distal portion comprises a first tine extending distally to a first distal end comprising a first distal aperture configured to receive a third securing member, and a second tine extending distally to a second distal end comprising a second distal aperture configured to receive a fourth securing member.

DETAILED DESCRIPTION

Implementations of the technology described herein are directed generally to implants and/or systems for treatment of bone fractures and associated methods. The following description and examples illustrate some exemplary implementations, embodiments, and arrangements of the disclosed invention in detail. Those of skill in the art will recognize that there are numerous variations and modifications of this invention that are encompassed by its scope. Accordingly, the description of a certain example embodiment should not be deemed to limit the scope of the present invention.

FIGS.1A and1Billustrate first and second views of a medial malleolar fracture110of a patient stabilized using tension band wiring130, in accordance with some example embodiments. Such tension banding techniques are often used on avulsion and transverse fracture patterns of the medial malleolus100(i.e., of the tibia), though the application of tension banding techniques are not limited to such fractures and/or fracture patterns. However, when such fracture patterns do occur, surgeons will often place two partially threaded cancellous bone screws through the fracture to achieve compression. However, studies have found that tension banding techniques, such as those illustrated inFIGS.1A and1B, are stronger than screw fixation in resisting clinical failure (e.g., greater than 2 mm of fracture displacement).

InFIGS.1A and1B, medial malleoli100are illustrated as having a distal fragment or section of bone105defined by fracture110. Fracture110is shown after having been completely reduced. Two Kirshner wires (K-wires)140are driven into distal fragment or section of bone105through and across fracture110on the tension side of bone100. A washer120is inserted over threads of a cancellous bone screw110and screw110is driven into the long bone of medial malleoli100approximately 2 to 3 cm above (e.g., proximal of) fracture110. Gauge wire130is wrapped around the head of screw110and around or through protruding portions of K-wires140in a “figure eight” motion. Gauge wire130is then twisted135and pulled to compress fracture110. Opposite compressive forces150and155are illustrated on either side of fracture110.

This disclosure provides implants and/or systems for treatment of foot and/or ankle fractures, and associated methods, which convert tensile forces of fractures to compression forces, while avoiding the disadvantages of the tensioning techniques previously described. Tension band plate200of this system is designed to mimic the tension banding technique ofFIGS.1A and1B, however, utilizing fewer components and/or fewer steps. Accordingly, tension plate200is designed with at least one goal of modernizing the K-wire tension band technique described in connection withFIGS.1A and1B.

Example Embodiments

FIGS.2-7and10-11illustrate tension band plates200,1000of the disclosed system, configured for use to fractures110on medial malleolus100.FIG.2illustrates tension band plate200on a right tibia100of a50th percentile male.FIG.3illustrates a top view of tension band plate200.FIG.4illustrates a side view of tension band plate200.FIG.5is a photograph of tension band plate200substantially as shown inFIG.3.FIG.6is a photograph of a first view of tension band plate200disposed on right tibia100similar to that shown inFIG.2. AndFIG.7illustrates a second view, perpendicular to the first view ofFIG.6, of tension band plate200disposed on right tibia100. Tension band plate200will now be described in more detail in connection with one or more ofFIGS.2-7. An alternative embodiment of plate200are also described in connection with at leastFIGS.10-11.

Tension band plate200comprises a proximal portion210and a distal portion220. Proximal portion210is configured to be disposed on and/or against a portion of bone100proximal of fracture110. Distal portion220is configured to be disposed on and/or against at least portions of bone105distal of fracture110.

Proximal portion210comprises a first proximal aperture202configured to receive a first securing member610(seeFIGS.6and7). In some embodiments, first proximal aperture202has a substantially circular shape and/or beveled or otherwise rounded edges. In some embodiments, first securing member610comprises one of a bone screw, a pin, a wire or a post. securing member. Accordingly, in some embodiments, first securing member610is configured to be driven into the long bone of malleoli100proximal (e.g., 2 to 3 cm) of fracture110.

Proximal portion210comprises a second proximal aperture204disposed distal of first proximal aperture202. In some embodiments, first proximal aperture202and/or second proximal aperture204comprises a combination compression/gliding aperture. In some embodiments, either or both of apertures202,204may comprise a locking compression/gliding hole. In some embodiments, either or both of apertures202,204may comprise a standard locking hole.

In some embodiments, second proximal aperture204is configured to receive a second securing member (not shown) similar to first securing member610. In some embodiments, second proximal aperture204is disposed along a centerline of plate200extending longitudinally through proximal and distal portions210,220. In some embodiments, second proximal aperture204has an elongated shape, for example a rectangle having parallel long sides and convex semicircles (e.g., bowing outward) for the short sides. In some embodiments, second proximal aperture204has a length L2of 7.11 mm to provide extra compression if needed or desired. In some embodiments, a spacing L1between first proximal aperture202and second proximal aperture204is approximately 7.62 mm.

Distal portion220comprises a first extension or tine222aextending distally, and in some cases slightly outwardly or laterally to one side of and compared to the longitudinal centerline. Distal portion220comprises a second extension or tine222bextending distally, and in some cases slightly outwardly or laterally to an opposite side of and compared to the longitudinal centerline. In some embodiments, a proximal portion of extensions or tines222a,222bhave a slight (e.g., 10-degree) bend in the lateral direction to decrease palpability of extensions or tines222a,222b.In some such embodiments, extensions or tines222a,222bthen angle back in (e.g., a bend in the medial direction by 5 degrees) to “hug” or conform to an underlying shape of a portion of the bone being reduced and/or stabilized, e.g., medial malleolus100, when placed in tension, which would not occur if extensions or tines222a,222bextended straight away distally of proximal portion210.

Extensions or tines222a,222bcomprise respective first and second distal apertures226a,226bdisposed within respective distal ends224a,224bof first and second extensions or tines222a,222b.Similar to first and second proximal apertures202,204, first and second distal apertures226a,226beach comprise a combination compression/gliding aperture. In some embodiments, either or both of apertures226a,226bmay comprise a locking compression/gliding hole. In some embodiments, either or both of apertures226a,226bmay comprise a standard locking hole.

First and second distal apertures226a,226bare configured to receive respective third and fourth securing members620a,620b.In some embodiments, third and fourth members620a,620bmay each comprise one of a bone screw, a pin, a wire or a post. Accordingly, in some embodiments, third and/or fourth securing members620a,620bmay be configured to be driven into bone105perpendicular to a plane of fracture110. In some embodiments, a longitudinal spacing L3between second proximal aperture204and each of first and second distal apertures226a,226bis approximately 23.6 mm.

Spacings between apertures of plate200are designed to adequately capture the fracture of the bone(s) being reduced and/or stabilized. In some such applications, such fracture(s) may comprise and/or involve a distal avulsion fragment105and proximal bone100. While particular spacings and/or dimensions are provided for one or more features of plate200, the present disclosure is not so limited and any suitable spacings and/or dimensions are also contemplated.

Although medial malleolus100of the tibia endures significant axial forces, tension band plate200does not need to be able to withstand these forces because the plate is only designed to convert the tensile forces caused from fractures into compression forces. The same applies to torsional requirements of tension band plate200. Accordingly, plate200may be made to have a substantially reduced thickness(es) compared to other plates and/or ankle stabilization offerings.

However, one of the considerations taken into account when designing tension band plate200is the prominent distal end of medial malleolus100. Accordingly, tension plate200has a varying thickness, for example, a thickness T1of 1.3 mm along proximal portion210of plate200and a thickness T2of 1.0 mm along distal portion220of plate200(e.g., along extensions and/or tines222a,222band distal apertures226a,226b). Thickness T2of 1.0 mm allows extensions and/or tines222a,222bto be easily and manually bent by the surgeon to match the contour of medial malleolus100. However, it is also important to ensure extensions and/or tines222a,222bwill not break while being bent. Extensions and/or tines222a,222bare thus designed to be bent, for example with bending pliers, multiple times without breaking.

The varying thicknesses, e.g., T1and T2, minimizes plate palpability and irritation, especially at the distal tip of the tibia where plate irritation commonly occurs, and can ultimately lead to decreased implant removal. Plate200eliminates a significant problem of high palpability and patient irritation with the current K-wire tension band techniques. This provides a particularly valuable proposition for the treatment of ankle fractures in the geriatric and/or osteopenic/osteoporotic patient population.

Tension band plate200may also comprise an edge profile (e.g., a perimeter) having a straight height H1of 0.48 mm (e.g., a substantially vertical side extending from a bottom edge of tension band plate200) and a rounded upper edge having a radius of curvature r1of 0.76 mm continuing from a top of the substantially vertical side. Such dimensions (e.g., at least H1and r1) give plate200a smooth vanishing edge that minimizes irritation and palpability. Since plate200is designed to be manipulated and bent, it does not have any curvature to specific anatomy (e.g., plate200is substantially flat). Such a substantially flat form also decreases the cost of manufacturing plate200.

A maximum width W2of proximal portion210is 10.16 mm. A minimum width W3of proximal portion210(e.g., at a scalloped portion240separating or defining a border between first and second portions210,220) is 7.91 mm. A difference between W2and W3allows for easy adaptation of the contouring of plate200while plate200is being sucked or pulled down against the patient specific anatomy. A maximum width W1of distal portion220of plate200is about 14.5 mm. In some embodiments, maximum width W1is selected based on the size of the distal portion of medial malleolus100such that the selection still allows third and fourth securing members620a,620bto be secured to (and/or driven into) bone fragment105, perpendicular to and through the plane of fracture110and into medial malleolus100.

In yet other embodiments, distal portion1020of plate1000may comprise just one of tines1022a,1022b.Likewise, in some embodiments, proximal portion1010of plate1000may comprise just one of tines1022c,1022d.

In some embodiments, rather than comprising a single aperture, one or more of apertures202,204,226a,226bmay each comprise a plurality of apertures, each configured to receive a respective securing member. Such embodiments may allow for even more advanced molding of plate200to the patient-specific anatomy.

In some embodiments, tension band plate200may only be offered in one overall length at least because adequate fixation of avulsion fractures of medial malleolus100can be achieved with fixation points provided by tension band plate200.

An alternative embodiment of tension band plate200, tension band plate1000, is illustrated inFIGS.10and11. Tension band plate1000is substantially a symmetrical mirror image of the portion of plate200distal of the midline of second proximal aperture204along the proximal-distal centerline of plate200.

Accordingly, plate1000comprises a proximal portion1010, a medial portion1030, and a distal portion1020. Proximal portion1010is configured to be disposed on and/or against a portion of bone100proximal of fracture110. Distal portion1020is configured to be disposed on and/or against at least portions of bone105distal of fracture110. Medial portion1030is disposed between proximal and distal portions1010,1020.

Medial portion1030comprises a medial aperture1004, which may substantially correspond to second proximal aperture204as previously described anywhere in this disclosure. Medial aperture1004may be disposed along a centerline of plate1000extending longitudinally through proximal, medial and distal portions1010,1030,1020. Medial aperture1004is configured to receive a securing member (not shown) similar to first securing member610as previously described anywhere in this disclosure.

Proximal portion1010comprises a first proximal extension or tine1022cextending distally, and in some cases slightly outwardly or laterally to one side of and compared to the longitudinal centerline. Proximal portion1010comprises a second extension or tine1022dextending distally, and in some cases slightly outwardly or laterally to an opposite side of and compared to the longitudinal centerline. In some embodiments, a distal portion of extensions or tines1022c,1022dhave a slight (e.g., 10-degree) bend in the lateral direction to decrease palpability of extensions or tines1022c,1022d.In some such embodiments, extensions or tines1022c,1022dthen angle back in (e.g., a bend in the medial direction by 5 degrees) to “hug” or conform to an underlying shape of a portion of the bone being reduced and/or stabilized when placed in tension, which would not occur if extensions or tines1022c,1022dextended straight away distally of proximal portion1010.

Extensions or tines1022c,1022dcomprise respective first and second proximal apertures1026c,1026ddisposed within respective proximal ends1024c,1024dof first and second proximal extensions or tines1022c,1022d.In some embodiments, first and second proximal apertures1026c,1026deach comprise a combination compression/gliding aperture, a locking compression/gliding hole or a standard locking hole.

First and second proximal apertures1026c,1026dare configured to receive respective first and second securing members (which are similar to securing members620a,620bas previously described in connection with plate200). In some embodiments, these first and second securing members may each comprise one of a bone screw, a pin, a wire or a post. Accordingly, in some embodiments, first and second securing members may be configured to be driven into bone perpendicular to a plane of the fracture. In some embodiments, a longitudinal spacing L3between medial aperture1004and each of first and second proximal apertures1026c,1026dis approximately 103.6 mm. While particular spacings and/or dimensions are provided for one or more features of plate1000, the present disclosure is not so limited and any suitable spacings and/or dimensions are also contemplated.

Distal portion1020comprises a first distal extension or tine1022aextending distally, and in some cases slightly outwardly or laterally to one side of and compared to the longitudinal centerline. Distal portion1020comprises a second extension or tine1022bextending distally, and in some cases slightly outwardly or laterally to an opposite side of and compared to the longitudinal centerline. In some embodiments, a proximal portion of extensions or tines1022a,222bhave a slight (e.g., 10-degree) bend in the lateral direction to decrease palpability of extensions or tines1022a,222b.In some such embodiments, extensions or tines1022a,222bthen angle back in (e.g., a bend in the medial direction by 5 degrees) to “hug” or conform to an underlying shape of a portion of the bone being reduced and/or stabilized, e.g., medial malleolus100, when placed in tension, which would not occur if extensions or tines1022a,222bextended straight away distally of proximal portion1010.

Extensions or tines1022a,1022bcomprise respective first and second distal apertures1026a,1026bdisposed within respective distal ends1024a,1024bof first and second extensions or tines1022a,1022b.In some embodiments, first and second distal apertures1026a,1026beach comprise a combination compression/gliding aperture, a locking compression/gliding hole or a standard locking hole.

First and second distal apertures1026a,1026bare configured to receive respective third and fourth securing members620a,620bas previously described in connection with plate200. In some embodiments, third and fourth members620a,620bmay each comprise one of a bone screw, a pin, a wire or a post. Accordingly, in some embodiments, third and/or fourth securing members620a,620bmay be configured to be driven into bone105perpendicular to a plane of fracture110. In some embodiments, a longitudinal spacing L3between medial aperture1004and each of first and second distal apertures1026a,1026bis approximately 103.6 mm. While particular spacings and/or dimensions are provided for one or more features of plate1000, the present disclosure is not so limited and any suitable spacings and/or dimensions are also contemplated.

Tension plate1000has a varying thickness, for example, a thickness T1of 1.3 mm along medial portion1030of plate1000and a thickness T2of 1.0 mm along proximal portion1010and distal portion1020of plate1000(e.g., along extensions and/or tines1022a,1022b,1022c,1022dand apertures1026a,1026b,1026c,1026d). Thickness T2of 1.0 mm allows extensions and/or tines1022a,1022b,1022c,1022dto be easily and manually bent by the surgeon to match the contour of the bone.

Tension band plate1000may also comprise an edge profile (e.g., a perimeter) having a straight height H1of 0.48 mm (e.g., a substantially vertical side extending from a bottom edge of tension band plate1000) and a rounded upper edge having a radius of curvature r1of 0.76 mm continuing from a top of the substantially vertical side. Such dimensions (e.g., at least H1and r1) give plate1000a smooth vanishing edge that minimizes irritation and palpability. Since plate1000is designed to be manipulated and bent, it does not have any curvature to specific anatomy (e.g., plate1000is substantially flat). Such a substantially flat form also decreases the cost of manufacturing plate1000.

The maximum width W2of medial portion1030is 10.16 mm. The minimum width W3of proximal portion1010(e.g., at a scalloped portion1040separating or defining a border between each of first and second portions1010,1020and medial portion1030) is 7.91 mm. The difference between W2and W3allows for easy adaptation of the contouring of plate1000while plate1000is being sucked or pulled down against the patient specific anatomy. A maximum width W1of each of proximal portion1010and of distal portion1020of plate1000is about 14.5 mm.

In yet other embodiments, distal portion1020of plate1000may comprise just one of tines1022a,1022b.Similarly, in in some embodiments, proximal portion1010of plate1000may comprise just one of tines1022c,1022d.

In some embodiments, rather than comprising a single aperture, one or more of apertures1040,1026a,1026b,1026c,1026dmay each comprise a plurality of apertures, each configured to receive a respective securing member. Such embodiments may allow for even more advanced molding of plate1000to the patient-specific anatomy.

Several procedures involving tension band plate200and/or1000will now be described with respect toFIGS.2-7and10-11. In some embodiments, tension band plate200,1000is disposed on the tensile side of bone100. Plate200,1000may provide tension using either of several example implantation procedures.

In a first example implantation procedure, tension band plate200,1000creates tension by inserting securing members620a,620binto distal apertures226a,226b,1026a,1026bat distal ends224a,224b1024a,1024bof extensions or tines222a,222b,1022a,1022bof plate200,1000(see,FIGS.6and7). Securing members620a,620bare secured to (and/or drive into) bone fragment105perpendicular to and through a plane of fracture110, and into bone100. Plate200,1000is provided unbent, thereby causing proximal portion210,1010of plate200,1000to protrude away from bone100once securing members620a,620bare inserted.

In some embodiments, where additional compression of fracture110is desired, a securing member (e.g., a non-locking screw) (not shown) may optionally be inserted into second proximal aperture204(or aperture1004of plate1000) and secured to (and/or driven into) bone100. Finally, first securing member610may be inserted into proximal aperture202in proximal portion210of plate200(or respective securing members may be inserted into corresponding apertures1026c,1026d). Since plate200,1000is provided unbent, securing and/or driving such a securing member through aperture204,1004and/or securing member610through aperture202(or respective securing members through corresponding apertures1026c,1026d) and into bone100causes extensions or tines222a,222b(1022a,1022b) to wrap around the distal portion of medial malleolus100,105and creates tension as plate200,1000is pulled down onto bone110, thereby converting tensile forces into compressive forces similar to150,155ofFIGS.1A,1B.

A second procedure to create tension may comprise first inserting the securing member (not shown) through second proximal aperture204(or aperture1004for plate1000) and into bone100, then inserting third and fourth securing members620a,620bthrough apertures226a,226b,1026a,1026band into bone fragment105perpendicular to and through a plane of fracture110, and into bone100, followed by inserting first securing member610into first proximal aperture202of plate200(or respective securing members through corresponding apertures1026c,1026d). As above, since plate200is provided unbent, driving securing member610through aperture202(or respective securing members through corresponding apertures1026c,1026d) and into bone100and/or securing members620a,620bthrough apertures226a,226b,1026a,1026band into bone105causes extensions or tines222a,222b,1022a,1022bto wrap around the distal portion of medial malleolus100,105and creates tension as plate200,1000is sucked or pulled down onto bone110, thereby converting tensile forces into compressive forces similar to150,155ofFIGS.1A,1B.

In some embodiments, a system comprising tension band plate200,1000provides a solution for treatment of tri-malleolar fractures as well as a solution for treatment of Danis-Weber fractures.

The described tension band plate200,1000is also advantageous because fracture110need not be reduced prior to implantation of tension band plate200,1000. Since band plate200,1000is provided unbent, reduction of fracture110will occur as second proximal aperture204(or aperture1004) is used, and/or as the remaining securing members are tightened, thereby pulling plate200,1000down onto bone100,105.

Example Method(s) of Use

The disclosure now turns toFIG.8and one or more example methods of using a tension band plate to treat tibial fractures, as described anywhere in this disclosure. Although particular steps are described herein, the present application is not so limited and alternative methods may include a subset of these steps, in the same or different order, and may additionally include one or more additional steps not described herein.

Step802includes disposing at least a portion of the tension band plate proximate to the fracture and against the bone. For example, as previously described in connection with at leastFIGS.2-7, a surgeon may dispose at least a portion of tension band plate200proximate to fracture110and against bone100,105. In some embodiments, the portion disposed against the bone may be one or both of first and second distal apertures226a,226bin preparation of securing third and fourth securing members622a,622btherethrough and to the bone. As previously described, tension band plate200comprises a proximal portion210and a distal portion220. Proximal portion includes first proximal aperture202configured to receive first securing member610and second proximal aperture204disposed distal of first proximal aperture202and configured to receive a second securing member (e.g., a non-locking screw) (not shown). Distal portion220includes first tine220aextending distally to first distal end224acomprising first distal aperture226aconfigured to receive third securing member620a, and second tine222bextending distally to second distal end224bcomprising second distal aperture226bconfigured to receive fourth securing member620b.Step802may also be carried out utilizing plate1000ofFIGS.10and11and its corresponding elements.

Step804includes driving the third and fourth securing members through the respective first and second distal apertures, into the bone distal of the fracture, and perpendicular to and through a plane of the fracture. For example, as previously described in connection with at leastFIGS.2-7, the surgeon may drive third and fourth securing members620a,620bthrough respective first and second distal apertures226a,226binto bone105distal of fracture110, and perpendicular to and through a plane of fracture110. Step804may also be carried out as described utilizing plate1000ofFIGS.10and11and its corresponding elements.

Step806includes driving the first securing member through the proximal aperture and into the bone proximal of the fracture, thereby causing at least the first and second tines to wrap around and conform to portions of the bone proximate to the fracture, pulling the proximal portion into contact with a portion of the bone proximal of the fracture, and converting tensile forces at the fracture into compressive forces. For example, as previously described in connection with at leastFIGS.2-7, the surgeon may drive first securing member610through first proximal aperture202and into bone100proximal of fracture110, thereby causing at least first and second tines222a,222bto wrap around and conform to portions of bone100,105proximate to fracture110, pulling proximal portion210into contact with a portion of bone100proximal of fracture110, and converting tensile forces at fracture110into stabilizing, compressive forces.

Where step806is carried out utilizing plate1000, the step may include driving a first securing member through first proximal aperture1026cand into the bone proximal of the fracture and a second securing member through second proximal aperture1026cand into the bone proximal of the fracture, thereby causing at least the first and second tines of each of the proximal and distal portions to wrap around and conform to portions of the bone proximate to the fracture, pulling the proximal portion into contact with a portion of the bone proximal of the fracture, and converting tensile forces at the fracture into compressive forces.

In some embodiments, flowchart800may include a step808, including driving the second securing member through the second proximal aperture and into the bone proximate of the fracture. While step808is illustrated after step806, the present disclosure contemplates also performing step808after step802and before step804or, alternatively, after step804and before step806.

For example and not limitation, as previously described in connection with at leastFIGS.2-7, in a first example procedure, where additional compression of fracture110is desired (for example where reduction is accomplished by implantation of plate200itself), a second securing member (not shown but similar to first securing member610) may be secured through second proximal aperture204and into bone100proximate of fracture110after driving third and fourth securing members into bone fragment105perpendicular to, and through, the plane of fracture110and into bone100, but before driving first securing member610into bone100proximal of fracture110.

For further example and not limitation, as previously described in connection with at leastFIGS.2-7, in a second example procedure, the second securing member (not shown) may be secured through second proximal aperture204and into bone100proximate of fracture110before driving third and fourth securing members into bone fragment105perpendicular to, and through, the plane of fracture110and into bone100, which may occur before driving first securing member610into bone100proximal of fracture110.

Where step808is carried out utilizing plate1000, the step would correspond to driving a fifth securing member though medial aperture1004, which corresponds to second proximal aperture204of plate200.

In some embodiments, a method related to flowchart800may include automatically reducing fracture110by driving first, second third, and fourth securing members610,620a,620binto the respective portions of bone100,105while at least a portion of tension band plate200is disposed against the portions of bone100,105proximate to unreduced fracture110and as at least a portion of tension band plate200conforms to the portions of bone100,105proximate to fracture110.

Where the reducing step is carried out utilizing plate1000, the step would correspond to driving the first through fifth securing members through their respective apertures and into their respective portions of bone while at least a portion of tension band plate1000is disposed against the portions of bone proximate to the unreduced fracture and as at least a portion of tension band plate1000conforms to the portions of bone proximate to the fracture.

Example Methods of Manufacture

The disclosure now turns toFIG.9and one or more example methods of manufacturing a tension band plate for treatment of tibial fractures, as described anywhere in this disclosure. Although particular steps are described herein, the present application is not so limited and alternative methods may include a subset of these steps, in the same or different order, and may additionally include one or more additional steps not described herein.

Step902includes forming a proximal portion of a tension band plate with a configuration for disposal against a portion of the bone proximal of the fracture at least in that the proximal portion comprises a first proximal aperture configured to receive a first securing member, and a second proximal aperture disposed distal of the first proximal aperture and configured to receive a second securing member.

For example, as previously described in connection with at leastFIGS.2-7, proximal portion210of tension band plate200may be formed configurated for disposal against a portion of bone100proximal of fracture110at least in that proximal portion210comprises first proximal aperture202configured to receive first securing member610, and second proximal aperture204disposed distal of first proximal aperture202and configured to receive a second securing member (not shown).

Where this method is utilizing to manufacture plate1000, step902may alternatively comprise forming medial portion1030comprising aperture1004and integrally forming proximal portion1010with a configuration for disposal against a portion of the bone proximal of the fracture at least in that the proximal portion comprises a first proximal tine1022cextending distally to a first proximal end1024c,1024dcomprising first proximal aperture1026aconfigured to receive a first securing member, and a second proximal tine1022cextending proximally to second proximal end1022dcomprising second proximal aperture1026dconfigured to receive a second securing member.

Step904includes integrally forming a distal portion of the tension band plate with a configuration for disposal against at least a portion of the bone distal of the fracture at least in that the distal portion comprises a first tine extending distally to a first distal end comprising a first distal aperture configured to receive a third securing member, and a second tine extending distally to a second distal end comprising a second distal aperture configured to receive a fourth securing member.

For example, as previously described in connection with at leastFIGS.2-7, distal portion220of tension band plate200may be formed configured for disposal against at least a portion of bone105distal of fracture110at least in that distal portion220comprises first tine220aextending distally to first distal end224acomprising first distal aperture226aconfigured to receive third securing member620a,and second tine222bextending distally to second distal end224bcomprising second distal aperture226bconfigured to receive fourth securing member620b.At least first and second tines222a,222bare formed with a configuration for wrapping around and conforming to portions of bone100,105proximate to fracture110and, thereby, a configuration for converting tensile forces at the fracture into compressive forces when first securing member610is secured through first proximal aperture202and into bone100proximal of fracture110, and third and fourth securing members620a,620bare driven through respective first and second distal apertures226a,226b,into bone105distal of fracture110, and perpendicular to and through the plane of fracture110.

Where this method is utilized to manufacture plate1000, step904may similarly comprise forming distal portion1020of tension band plate1000with a configuration for disposal against at least a portion of the bone distal of the fracture at least in that distal portion1020comprises first tine1022aextending distally to first distal end1024acomprising first distal aperture1026aconfigured to receive a third securing member, and second tine1022bextending distally to second distal end1024bcomprising second distal aperture1026bconfigured to receive a fourth securing member. In some embodiments, a method related to flowchart900may include manufacturing tension band plate200such that a thickness of the tension band plate decreases from a first thickness T1at proximal portion210to a second thickness T2less than the first thickness along at least first and second tines222a,222bof distal portion220, thereby allowing first and second tines222a,222bto be manually bent to match a contour of at least portion105of bone100distal of fracture110.

Where this method is utilized to manufacture plate100, a method related to flowchart may include manufacturing tension band plate1000such that a thickness of the tension band plate decreases from a first thickness T1at medial portion1030to a second thickness T2less than the first thickness along at least first and second tines1022a,1022b,1022c,1022dof distal and proximal portions1020,1010, thereby allowing tines1022a,1022b,1022c,1022dto be manually bent to match a contour of at least a portion of the bone distal of the fracture.

In some embodiments, a method related to flowchart900may include forming proximal and distal portions210,220to have an edge profile with a substantially vertical side with height H1extending from a bottom edge and a rounded upper edge.

In some embodiments, a method related to flowchart900may include forming scalloped portion240(or portions1040) that separates and defines a border between proximal portion210and distal portion220(or between medial portion1030and each of proximal and distal portions1010,1020).

General Interpretive Principles for the Present Disclosure

Various aspects of the novel systems, apparatuses, and methods are described more fully hereinafter with reference to the accompanying drawings. The teachings disclosure may, however, be embodied in many different forms and should not be construed as limited to any specific structure or function presented throughout this disclosure. Rather, these aspects are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art. Based on the teachings herein one skilled in the art should appreciate that the scope of the disclosure is intended to cover any aspect of the novel systems, apparatuses, and methods disclosed herein, whether implemented independently of or combined with any other aspect of the disclosure. For example, a system or an apparatus may be implemented, or a method may be practiced using any one or more of the aspects set forth herein. In addition, the scope of the disclosure is intended to cover such a system, apparatus or method which is practiced using other structure, functionality, or structure and functionality in addition to or other than the various aspects of the disclosure set forth herein. It should be understood that any aspect disclosed herein may be set forth in one or more elements of a claim. Although some benefits and advantages of the preferred aspects are mentioned, the scope of the disclosure is not intended to be limited to particular benefits, uses, or objectives. The detailed description and drawings are merely illustrative of the disclosure rather than limiting, the scope of the disclosure being defined by the appended claims and equivalents thereof.

When describing an absolute value of a characteristic or property of a thing or act described herein, the terms “substantial,” “substantially,” “essentially,” “approximately,” and/or other terms or phrases of degree may be used without the specific recitation of a numerical range. When applied to a characteristic or property of a thing or act described herein, these terms refer to a range of the characteristic or property that is consistent with providing a desired function associated with that characteristic or property.

In those cases where a single numerical value is given for a characteristic or property, it is intended to be interpreted as at least covering deviations of that value within one significant digit of the numerical value given.

If a numerical value or range of numerical values is provided to define a characteristic or property of a thing or act described herein, whether or not the value or range is qualified with a term of degree, a specific method of measuring the characteristic or property may be defined herein as well. In the event no specific method of measuring the characteristic or property is defined herein, and there are different generally accepted methods of measurement for the characteristic or property, then the measurement method should be interpreted as the method of measurement that would most likely be adopted by one of ordinary skill in the art given the description and context of the characteristic or property. In the further event there is more than one method of measurement that is equally likely to be adopted by one of ordinary skill in the art to measure the characteristic or property, the value or range of values should be interpreted as being met regardless of which method of measurement is chosen.

It will be understood by those within the art that terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are intended as “open” terms unless specifically indicated otherwise (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” etc.).

In those instances where a convention analogous to “at least one of A, B, and C” is used, such a construction would include systems that have A alone, B alone, C alone, A and B together without C, A and C together without B, B and C together without A, as well as A, B, and C together. It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase “A or B” will be understood to include A without B, B without A, as well as A and B together.”

Certain features that are described in this specification in the context of separate implementations also can be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation also can be implemented in multiple implementations separately or in any suitable sub-combination. Moreover, although features can be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination can be directed to a sub-combination or variation of a sub-combination.