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NXT-5PROV NXT-5, 6, 7, 8 |
As used herein, a “long bone” refers to a bone of a patient having a length greater than a width of the bone. Long bone is one of five types of bones: long, short, flat, irregular and sesamoid. Long bones, especially the femur and tibia, can be subjected to most of the load during daily activities. Long bones grow primarily by elongation of the diaphysis, with an epiphysis at each end of the growing bone. The ends of epiphyses are covered with hyaline cartilage ("articular cartilage"). The longitudinal growth of long bones is a result of endochondral ossification at the epiphyseal plate. The long bone category type includes the femur, tibia, and fibula of the legs; the humerus, radius, and ulna of the arms; metacarpals and metatarsals of the hands and feet, the phalanges of the fingers and toes, and the clavicles or collar bones in humans or other patients. The outside of the long bone consists of a layer of connective tissue called the periosteum. Additionally, the outer shell of the long bone is compact bone, then a deeper layer of cancellous bone (spongy bone) which includes a medullary cavity that includes bone marrow. (Search "long bone" on Wikipedia.com May 14, 2021. CC-BY-SA 3.0 Modified. Accessed July 26, 2021.) |
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NXT-5PROV NXT-5, 6, 7, 8 |
As used herein, “periprosthetic” refers to a structure positioned in close relation to an implant. Periprosthetic can also be used as an adjective to describe a type of bone fracture. For example, a periprosthetic fracture is a fracture near or around an implant of prosthetic. (Search "periprosthetic" on Wikipedia.com Sept. 20, 2020. CC-BY-SA 3.0 Modified. Accessed July 26, 2021.) |
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NXT-5PROV NXT-5, 6, 7, 8 |
As used herein, an “arm” refers to an elongated structure that extends from another structure such as a base or a body. In certain embodiments, an arm can be configured to support a load (including a tension, compression, shear, torsion, and/or bending load). In certain embodiments, an arm may comprise a generally planar structure. An arm can be a separate structure connected to, or integrated with, another structure. Based on how the arm connects to or extends from another structure, such as a base or body, the arm can resemble an arm of a human or animal in that the arm can be an appendage to another structure. An arm can be two-dimensional or three-dimensional and can have a variety of geometric shapes and/or cross-sectional shapes, including, but not limited to a rectangle, a square, or other polygon, as well as a circle, an ellipse, an ovoid, or other circular or semi-circular shape. An arm can be made from a variety of materials including, metal, plastic, ceramic, wood, fiberglass, or the like. One arm may be distinguished from another based on where the arm is positioned within a structure, component, or apparatus. |
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NXT-5PROV NXT-5, 6, 7, 8 |
As used herein, “adapter” refers to a device, component, system, assembly, or structure, that is organized, configured, designed, arranged, or engineered to convert or convey attributes, features, or functions of one device, component, or structure, for use with an otherwise incompatible device, component, system, assembly, or structure. (Search "adapter" on Wikipedia.com May 13, 2021. CC-BY-SA 3.0 Modified. Accessed July 27, 2021.) An adapter may include one or more modifiers that identify one or more particular functions, attributes, advantages, uses, purposes, or operations and/or particular structures relating to the adapter. Examples of such modifiers applied to a feature, include, but are not limited to, "offset adapter," "accessibility adapter," "accommodation adapter," "detour adapter," "routing adapter," "rerouting adapter," and the like. |
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NXT-5PROV NXT-5, 6, 7, 8 |
As used herein, a “deploy” or "deployment" refers to an act, action, process, system, method, means, or apparatus for inserting an implant or prosthesis into a part, body part, and/or patient. “Deploy” or "deployment" can also refer to an act, action, process, system, method, means, or apparatus for placing something into therapeutic use. A device, system, component, medication, drug, compound, or nutrient may be deployed by a human operator, a mechanical device, an automated system, a computer system or program, a robotic system, or the like. |
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NXT-5PROV NXT-5, 6, 7, 8 |
As used herein, "feature" refers to a distinctive attribute or aspect of something. (Search "feature" on google.com. Oxford Languages, 2021. Web. 20 Apr. 2021.) A feature may include one or more modifiers that identify one or more particular functions, attributes, advantages, or operations and/or particular structures relating to the feature. Examples of such modifiers applied to a feature, include, but are not limited to, "attachment feature," "securing feature," "alignment feature," "adjustment feature," "guide feature," "protruding feature," "engagement feature," “fixation feature”, "disengagement feature," and the like. |
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NXT-5PROV NXT-5, 6, 7, 8 |
1.An intramedullary nail for a long bone of a patient, the nail comprising: |
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NXT-5PROV NXT-5, 6, 7, 8 |
Figure 1A illustrates an example of a fixation device according to one embodiment of the present disclosure. In one embodiment, the fixation device may comprise an intramedullary nail. The intramedullary nail 100 is illustrated deployed within a long bone, such as a femur 102. The illustrated intramedullary nail 100 is one example of an IMDF that may be used in accordance with the present disclosure. |
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NXT-5PROV NXT-5, 6, 7, 8 |
The offset section 116 redirects the distal end 104 posteriorly within a distal end of the long bone. For example, in a femur, the offset section 116 redirects the distal end 104 from a conventional entry point (i.e. one that may be used in patient’s without a distal joint prosthesis) that would be between the lateral condyle, medial condyle, and patellar surface to another entry point more posterior between the lateral condyle and medial condyle, such as for example, within the intercondylar fossa (e.g., the posterior intercondyloid fossa). Advantageously, the offset section 116 permits a surgeon to perform a retrograde deployment from a distal end of long bone at an entry point that is more posterior than may be used conventionally. Deploying an intramedullary nail 100 at an entry point that is more posterior can be advantageous where a patient has received a total knee replacement (TKR) or partial knee replacement that includes a femoral component implant that blocks access to the medullary canal by way of an entry point more anterior between the lateral condyle and medial condyles (e.g., at the middle of the intercondylar sulcus). Advantageously, the section 116 can be designed to accommodate a variety of prosthesis that may be deployed with a patient. For example, the section 116 can be configured to account for prosthesis such as a joint or fixation prostheses, femoral component for a partial or total knee replacement (TKR) procedure, a femoral component for a total hip replacement, and/or to address a peri-implant fracture of a patient’s bone. |
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NXT-5PROV NXT-5, 6, 7, 8 |
The distal end 104 includes an offset section 116. The offset section 116 serves to interconnect a distal end of the distal end 104, the coupling 110, to the remainder of the intramedullary nail 100 (e.g., the shaft 108). The offset section 116 may have a variety of configurations, one example of which is disclosed herein. |
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NXT-5PROV NXT-5, 6, 7, 8 |
The proximal end 106 may include a point 112. The point 112 may comprise a tapered wall that has an increasing smaller diameter until the point 112 comes to a single point or defines a blunt end surface for the point 112. The point 112 serves to facilitate deployment of the intramedullary nail 100 within the medullary cavity/canal. The point 112 can help guide the proximal end 106 through the medullary cavity/canal and can help move bone marrow aside as the intramedullary nail 100 is deployed. In certain embodiments, the proximal end 106 may also include one or more openings (not shown) for accepting a fastener (e.g., a bone screw) used to lock the intramedullary nail 100 in place, or fix the intramedullary nail 100, in place within the long bone. The one or more openings may include internal threads that engage threads of a fastener or may permit the fastener to pass through the intramedullary nail 100 and engage bone on an opposite side of the one or more openings. |
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NXT-5PROV NXT-5, 6, 7, 8 |
The shaft 108, distal end 104, and proximal end 106 may be manufactured from a single piece of material. In another embodiment, the shaft 108, distal end 104, the proximal end 106 may each or a combination of them be made from a single piece of material that is then connected, joined, or coupled to form the intramedullary nail 100. |
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NXT-5PROV NXT-5, 6, 7, 8 |
The shaft 108 connects the distal end 104 and the proximal end 106. The length of the shaft 108 may determine the length of the intramedullary nail 100. In certain embodiments, the shaft 108 include a curve or bow such that the intramedullary nail 100 follows a natural curve in the intramedullary canal of a patient’s long bone. |
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NXT-5PROV NXT-5, 6, 7, 8 |
The cross-sectional diameter and length of the intramedullary nail 100 can vary depending on the age, gender, nature and position of long bone fracture(s) (e.g., diaphyseal, metaphyseal, periarticular, etc.), size of the patient, and the like. In certain embodiments, an intramedullary nail 100 having about a 10 mm cross section can be used. The shaft 108 is a rigid structure that connects the distal end 104 and proximal end 106. The distal end 104 and proximal end 106 may each also be rigid. In certain embodiments, the shaft 108, distal end 104, and/or proximal end 106 may include some level of resilience. The amount of resilience in the shaft 108, distal end 104, and/or proximal end 106 may vary or may be consistent and may be engineered to facilitate deployment of the intramedullary nail 100 within the medullary canal of the long bone. |
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NXT-5PROV NXT-5, 6, 7, 8 |
Figure 1B is a perspective side view of the intramedullary nail 100 of FIG. 1A, according to one embodiment. The intramedullary nail 100 serves to provide weight bearing load, axial loading, and structural support for the long bone (e.g., femur 102) of a patient. The intramedullary nail 100 may be made from a variety of biocompatible materials used in IMDFs. The intramedullary nail 100 may be hollow along its length. The passage through the intramedullary nail 100 may permit deployment of the intramedullary nail 100 along a guide wire. The intramedullary nail 100 may have a longitudinal cross section that is circular, ovoid, polygonal, or the like. |
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NXT-5PROV NXT-5, 6, 7, 8 |
The intramedullary nail 100 may include a distal end 104, a proximal end 106, and a shaft 108. The distal end 104 may include a coupling 110 and the proximal end 106 may include a point 112. The intramedullary nail 100 includes a longitudinal axis 114. |
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NXT-5PROV NXT-5, 6, 7, 8 |
Referring to FIG. 1C and 1D, in one embodiment, the offset section 116 includes a first bend 118 and a second bend 120. The first bend 118 and second bend 120 may be described by how the bends are angled in relation to the longitudinal axis 114 of the intramedullary nail 100. For example, in one embodiment, the first bend 118 is angled posteriorly from the longitudinal axis 114 when the intramedullary nail 100 is deployed within a long bone of a patient. The first bend 118 may define a first angle 126 between the longitudinal axis 114 and a body 128 of the offset section 116. The first angle 126 may be a variety of angles and may range from between about 3 degrees and about 90 degrees. In certain embodiments, the first angle 126 may be about 45 degrees. |
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NXT-5PROV NXT-5, 6, 7, 8 |
It is desirable that bone plates be as thin, short, light weight, and flexible as possible. However, bone plates with such characteristics may provide insufficient fixation of a long bone when used in isolation. Intramedullary nails may provide sufficient fixation but may have other limitations. A fixation system is needed that includes a thinner and/or more suitably flexible bone plate and an intramedullary nail that together provide the desired fixation of the long bone with a facture. |
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NXT-5PROV NXT-5, 6, 7, 8 |
Conventional lateral bone plates offer limited deployment configurations that may not accommodate anatomical variations between patients. A simple modular lateral bone plate that facilitates fixation that accounts for patient variations and needs determined both before and during surgery is needed. |
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NXT-5PROV NXT-5, 6, 7, 8 |
Conventional medial bone plates offer limited fixation structures that account for arteries in close proximity to the long bone (e.g., a neurovascular bundle or femoral artery near the medial side of the femur). A simple medial bone plate that facilitates fixation that accounts for arteries and/or a neurovascular bundle in close proximity to the long bone is needed. |
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