This International Application claims priority from a Patent Application filed in India having Patent Application No. 202041038201, filed on September 04, 2020, and titled “AN INTRAMEDULLARY INTERLOCKING NAILING APPARATUS”.

FIELD OF INVENTION

Embodiments of a present invention relate to an intramedullary interlocking nail, and more particularly to, an intramedullary interlocking nailing apparatus comprising an expandable screw.

BACKGROUND

The intramedullary fixation devices had been in existence since 1940. The Interlocking Nail is a cylindrical hollow rod connected with the sets of 2 or 3 screws on either end. Since then, few minor modifications such as increase in the number of screws were introduced in the design/structure of the interlocking nail, which is a conventional design as per today. The interlocking screw provides the rotational stability at a fracture site of a bone of a user and improves the Nail-Bone Construct stability. However, such conventional design, in some specific fractures like segmental fractures, does not provide rotational stability to the intermediate segment, thereby burdened with higher rate of non union or failure of fracture to unite.. Also, the current conventional nails are not equipped to treat Segmental Fractures which resulted in lot of fracture fixation failures over decades.

Hence there is a need for an improved intramedullary interlocking nailing apparatus to address the aforementioned issues.

BRIEF DESCRIPTION

In accordance with one embodiment of the disclosure, an intramedullary interlocking nailing apparatus is disclosed. The apparatus includes a nail body comprising a proximal section, a middle section and a distal section. The nail body also includes a first set of holes. Each of the first set of holes are placed at the proximal section of the nail body. The first set of holes are fastened to a segment using at least one first fixation means. The nail body also includes a second set of holes. Each of the second set of holes are placed at the distal section of the nail body using at least one second fixation means. The first set of holes also includes at least one intermediate hole placed on the middle section. The intermediate hole is configured to be affixed to a bone of a user via one or more intermediate fixation means when the bone is fractured in at least one part. The at least one intermediate hole includes an expandable screw housed within the corresponding at least one intermediate hole. The expandable screw is configured to couple the nail body to the bone of the user. The expandable screw includes an inner body, an outer body configured to drive the expandable screw through bone and a screw body. The inner head is directly coupled to the screw body and the outer head is located around the inner head. The expandable screw also includes operable means located on either ends of an inner wall of the screw body. The operable means is configured to enable the operation of the expandable screw.

To further clarify the advantages and features of the present disclosure, a more particular description of the disclosure will follow by reference to specific embodiments thereof, which are illustrated in the appended figures. It is to be appreciated that these figures depict only typical embodiments of the disclosure and are therefore not to be considered limiting in scope. The disclosure will be described and explained with additional specificity and detail with the appended figures.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure will be described and explained with additional specificity and detail with the accompanying figures in which:

FIG. 1 is a schematic representation of a nail body of an intramedullary interlocking nailing apparatus in accordance with an embodiment of the present disclosure; FIG. 2 is a schematic representation of a nail body having at least one slot in a midsection of the intramedullary interlocking nailing apparatus of FIG. 1 in accordance with an embodiment of the present disclosure;

FIG. 3 is a schematic representation of an expandable screw of the intramedullary interlocking nailing apparatus of FIG. 1 in accordance with an embodiment of the present disclosure; and

FIG. 4a and FIG. 4b are schematic representations of the nail body attached to a bone of a user of the intramedullary interlocking nailing apparatus of FIG. 1 in accordance with an embodiment of the present disclosure.

Further, those skilled in the art will appreciate that elements in the figures are illustrated for simplicity and may not have necessarily been drawn to scale. Furthermore, in terms of the construction of the device, one or more components of the device may have been represented in the figures by conventional symbols, and the figures may show only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the figures with details that will be readily apparent to those skilled in the art having the benefit of the description herein.

DETAILED DESCRIPTION

For the purpose of promoting an understanding of the principles of the disclosure, reference will now be made to the embodiment illustrated in the figures and specific language will be used to describe them. It will nevertheless be understood that no limitation of the scope of the disclosure is thereby intended. Such alterations and further modifications in the illustrated system, and such further applications of the principles of the disclosure as would normally occur to those skilled in the art are to be construed as being within the scope of the present disclosure.

The terms "comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such a process or method. Similarly, one or more devices or sub-systems or elements or structures or components preceded by comprises... a does not, without more constraints, preclude the existence of other devices, sub-systems, elements, structures, components, additional devices, additional sub-systems, additional elements, additional structures or additional components. Appearances of the phrase "in an embodiment", "in another embodiment" and similar language throughout this specification may, but not necessarily do, all refer to the same embodiment.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this disclosure belongs. The system, process, and examples provided herein are only illustrative and not intended to be limiting.

In the following specification and the claims, reference will be made to a number of terms, which shall be defined to have the following meanings. The singular forms “a”, “an”, and “the” include plural references unless the context clearly dictates otherwise.

Embodiments of the present disclosure relate to an intramedullary interlocking nailing apparatus. As used herein, the term “intramedullary interlocking nail” is defined as intramedullary nail (IM nail) or inter-locking nail is a metal rod forced into the medullary cavity of a bone. IM nails have long been used to treat fractures of long bones of the body of a patient.

FIG. 1 is a schematic representation of a nail body (20) of an intramedullary interlocking nailing apparatus (10) in accordance with an embodiment of the present disclosure. The apparatus (10) includes a nail body (20) comprising a proximal section (30), a middle section (40) and a distal section (50). In one embodiment, multiple sections (40) of the nail body (20) may be represented based on a reference point. In one exemplary embodiment, the nail body may correspond to one of a Femur Antegrade and retrograde nail, a Proximal Femur nail of one of a 1 ^st , 2 ^nd or a 3 ^rd generation, an Antegrade tibial nail, an Expert tibial nail, an Antegrade Humerus nail, a Fong stem Femur Hemi-arthroplasy prosthesis, or the like. In one specific embodiment, the proximal section (30) may be bent at a first pre-defined angle from the middle section (40). Also, the distal section (50) may be bent at a second pre-defined angle from the middle section (50).

The nail body (20) includes a first set of holes (60). Each of the first set of holes (60) are placed at the proximal section (40) of the nail body (20). The first set of holes (60) are fastened to a segment using at least one first fixation means. In one embodiment, the first fixation means may correspond to a nail which may be fastened via thread on a body of the nail. The nail body (20) also includes a second set of holes (80). Each of the second set of holes (80) are placed at the distal section (50) of the nail body (20) using at least one second fixation means. In one embodiment, the at least one second fixation means may correspond to a nail which may be fastened via thread on a body of the nail.

Furthermore, the nail body (20) includes at least one intermediate hole (90) placed on the middle section (40). In one exemplary embodiment, the middle section (40) may include multiple intermediate holes (90) which may be designed based on the requirement of the user. In one embodiment, the user may correspond to a patient. The at least one intermediate hole (90) is configured to be affixed to a bone of a user via one or more intermediate fixation means when the bone is fractured in at least one part. In one exemplary embodiment, the bone of the user may correspond to one of Femur, Tibia or Humerus of the user body. Further, the one or more intermediate fixation means (95) includes an expandable screw (100) housed within the corresponding at least one intermediate hole (90). The expandable screw (100) is configured to couple the nail body (20) to the bone of the user. The expandable screw (100) is configured to operate as per requirement of an authorized user to fix the fracture of the bone of the user. In one embodiment, the operation of the expandable screw (100) may correspond to expansion and contraction within the at least one intermediate hole (90) to fix the bone to the nail body. In one exemplary embodiment, at least one intermediate hole (90) are being introduced to allow fixation of bone in that region, at least one intermediate hole (90) may be in combination of two holes, three holes, four holes, five holes and six holes, and one long hole. In such embodiment, the at least one intermediate hole (90) which may range from one to six may be placed at equal intervals. More specifically, each of the at least one intermediate hole (90) may be placed at equal distances from each other or from a reference point.

The expandable screw (100) (as shown in FIG. 3) includes an inner head (110). In one embodiment, the inner head (110) may be configured to affix to an external surface of the bone of the user to provide additional grip to the nailing apparatus. In one exemplary embodiment, the inner head (110) is either hexagonal or slotted mainly hexagonal. The expandable screw (100) also includes an outer head (120) configured to drive the expandable screw (100) through bone. More specifically, the inner head (110) may be housed within the outer head (120) towards the bone. In one exemplary embodiment, the outer head (120) may include two parts one is Hexagonal head and second is a threaded base around the neck to anchor into the bone.

The expandable screw (100) also includes a screw body (130). The inner head (110) is directly coupled to the screw body (130) and the outer head (120) is located around the inner head (110). Also, the screw body (130) is affixed to the bone of the user. The expandable screw (100) also includes an operable means (140) located on either ends of an inner wall of the screw body (130). The operable means (140) is configured to enable the operation of the expandable screw (100). In one embodiment, the operable means ( 140) may correspond to expanding blades of the outer construct’ s surface which may be spiked or gritted to ensure better hold onto the nail.

In one exemplary embodiment, the nail body (20) may include an inner slot (70) (as shown in FIG. 2) configured to enable the expandable screw to fit into the corresponding at least one intermediate hole via the inner wall. In such embodiment, an external surface of the screw body gets attached to inner wall when the expandable screw is expanded as a function of operation, thereby preventing sliding of the expandable screw (100) from the nail body (20).

In one specific embodiment, the expandable screw (100) may further include a thread (150) wound from the inner head (110) until an exterior end of the expandable screw (100). In one exemplary embodiment, the holes or slots inner surface must be either grooved or pitted for the spikes or grit on the screw surface (140) to lodge into each other and ensure good grip or hold when expanded (as shown in FIG. 2).

In operation, the nail body (20) is inserted into the body of the user along a bone which may be fractured (as shown in FIGs. 4a and 4b). Further, the first set of fixation means is used to fasten the nail body at the proximal section (30) through the first set of holes (60). Simultaneously, the second set of fixation means is used to fasten the nail body (20) at the distal section (50) through the second set of holes (80). Also, the authorized user may insert the expandable screw (100) which corresponds to the one or more intermediate fixation means (95) by holding the same via the outer head (120). As the expandable screw (100) is driven along the middle section (40) via the operable means (140) which is compressed while being inserted. Further the operable means (140) expands when the screw body (130) is inserted into the bone across the at least one intermediate hole (90) in the middle section (40) to hold the intramedullary interlocking nail (20) secured, thereby enabling the intramedullary interlocking nail to work in both static and dynamic modes.

Various embodiments of the intramedullary interlocking nailing apparatus to provide a feature to enable both static and dynamic modes of operation using the expandable screw which is introduced in the middle section of the nail body with at least one intermediate hole, thereby making the apparatus more reliable and efficient. The holes or slots in the middle part of the nail with the combination of expandable screw mechanism will interlock the intermediate segment of the bone which in turn provides rotational stability, resulting in proper fixation of bone. Since the new modification is long slots or holes which helps in dynamic fixation. The expandable screw will also help in static fixation giving the surgeon a wide range of ease for fixing the fracture, which is not present in conventional nails. The expandable screw is the specialized screw with a specialized mechanism causing the expansion of the outer shell of the screw in middle thereby locking itself to the nail and providing static locking option for the surgeon. This screw mechanism, the modification of the nail and surgeon’s expertise help in preventing non-unions in segmental and complicated fractures and thereby helping the patient’s speedy recovery. While specific language has been used to describe the disclosure, any limitations arising on account of the same are not intended. As would be apparent to a person skilled in the art, various working modifications may be made to the method in order to implement the inventive concept as taught herein. The figures and the foregoing description give examples of embodiments. Those skilled in the art will appreciate that one or more of the described elements may well be combined into a single functional element. Alternatively, certain elements may be split into multiple functional elements. Elements from one embodiment may be added to another embodiment. For example, order of processes described herein may be changed and are not limited to the manner described herein. Moreover, the actions of any flow diagram need not be implemented in the order shown; nor do all of the acts need to be necessarily performed. Also, those acts that are not dependent on other acts may be performed in parallel with the other acts. The scope of embodiments is by no means limited by these specific examples.