Description:FIELD OF THE INVENTION
[001] The present invention relates to the field of surgical instruments, and more particularly, the present invention relates to an expandable and lockable intramedullary bone fixation device and bone repair method.

BACKGROUND FOR THE INVENTION:
[002] The following discussion of the background to the invention is intended to facilitate an understanding of the present invention. However, it should be appreciated that the discussion is not an acknowledgment or admission that any of the material referred to was published, known, or part of the common general knowledge in any jurisdiction as of the priority date of the application. The details provided herein the background if belongs to any publication is taken only as a reference for describing the problems, in general terminologies or principles or both of science and technology in the associated prior art.
[003] Earlier bone fractures were treated using nails of a non-corrosive material driven into the bone cavity to re-join and reinforce the broken bone parts. Since these nails had to be thin, thus were usually not strong enough to take up the stresses to permit limb functioning until healed. However, the stronger nails in many shapes currently being used, made of stainless steel, or cobalt-chrome alloy or cobalt chromium and titanium, require enlargement of the medullary cavity by reaming the bone.
[004] An intramedullary rod or, intramedullary nail or inter-locking nail is a metal rod that is inserted and forced into the medullary cavity of a bone to treat fractures. During World War I, Hey Groves of England reported the use of metallic rods for the treatment of gunshot wounds (Hey Groves EW. 1914. On the application of the principle of an extension to comminuted fractures of the long bone, with special reference to gunshot injuries. Br J Surg. 2: 429-43). Intramedullary nails resulted in quick recovery of the soldiers. Bone fractures are the most common in people with osteoporosis, characterized by compromised bone strength due to low bone mass which enhances risk of fracture, particularly at the spine, hip, wrist, humerus, and pelvis (Riggs BL, Melton LJ 3rd.
[005] The worldwide problem of osteoporosis: insights afforded by epidemiology. 1995. Bone 17: Fractures may result in limitation of ambulation, depression, loss of independence, and chronic pain (Johnell O, Kanis JA. 2016. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int 17: 1726). Surgery to correct the broken bone or replace it is the most common treatment for fractures on the road to recovery. Long bone fractures, especially tibia, account for most trauma-related emergency surgeries, and intramedullary nailing is a common method for treating tibial shaft fractures (Compston JE, McClung MR, Leslie WD. Osteoporosis. Lancet 2019; 393: 364-376. doi:10.1016/S0140-6736(18)32112-3; Tile M. Fractures of the tibia. Schatzker J, Tile M, eds. The Rationale of Operative Fracture Care. (2000) 2nd ed. New York: Springer-Verlag; Liu J, Xie L, Liu L, Gao G, Zhou P, Chu D, Qiu D, Tao J. 2023. Intramedullary nailing has been used extensively (Whitelaw GP, Cimino WG, Segal D. 1990. Application of small-diameter intramedullary nailing in the treatment of tibial fractures showed hardware failure which highly correlated with the delayed union (Whittle AP, Wester W, Russell TA. 1995. Fatigue failure in small diameter tibial nails. Clin Orthop Relat Res. 315: 119–128); fatigue breakage if bone healing does not occur (Lin J, Lin SJ, Chen PQ, Yang SH. 2001. Stress analysis of the distal locking screws for femoral interlocking nailing. J Orthop Res. 19: 57–63; Liu J, Xie L, Liu L, Gao G, Zhou P, Chu D, Qiu D, Tao J. 2023. Comparing external fixators and intramedullary nailing for treating open tibia fractures: a meta-analysis of randomized controlled trials. J Orthop Surg Res. 18:13. doi: 10.1186/s13018-022-03490-x).
[006] The applicant has conducted a worldwide prior art patent search before filing the present patent application. Some of the cited patent prior art documents comprise but not limited to: US2502267, US3118444, US3710789, US3846846, US4016874, US4064567, US4091806, CN219254347U, CN116370051A, CN219230080U, US20200113609A1, and US11583328B2 etc.
[007] In light of the foregoing, there is a need for a bone fixation device that overcomes problems prevalent in the prior art.

OBJECTS OF THE INVENTION:
[008] Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows.
[009] The principal object of the present invention is to overcome the disadvantages of the prior art by providing the Bone fixation device.
[010] An object of the present invention is to provide the bone fixation device that is required to treat bone fractures which permits faster functional rehabilitation, thus avoiding the occurrence of muscle atrophy and less problem of hardware failure.
[011] Another object of the present invention is to provide the bone fixation device that is also helpful in using a novel design of an intramedullary nailing device due to the simplicity of the design, thus cutting costs.
[012] Another object of the present invention is to provide the bone fixation device, wherein the bone segments are positioned in proximity to each other to enable the intramedullary nailing device to facilitate both longitudinal curvature and transverse compression by using anchors to set in place of deployment securely.
[013] Another object of the present invention is to provide the bone fixation device that provides for reconstructing and reinforcing bones, including diseased, osteoporotic, and fractured bones.
[014] Yet another object of the present invention is to provide the bone fixation device that helps to return to early mobility and full function, with the added advantage of minimal soft tissue morbidity.
[015] Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.

SUMMARY OF THE INVENTION:
[016] The present invention provides a bone fixation device that allows surgeons and their patients to benefit from the safest and most effective bone healing systems without causing any stress to the patient and causing minimum loss of time and with maximum safety. The device treats bone fractures which permits faster functional rehabilitation, thus avoiding the occurrence of muscle atrophy and less problem of hardware failure. The bone segments are positioned in proximity to each other to enable the intramedullary nailing device to facilitate both longitudinal curvature and transverse compression by using anchors to set in place of deployment securely. The process involves intensive reaming of the medullary cavity. It sometimes results in the weakening of the bone shaft and a reduction in the blood supply required for quick healing. The present invention relates to an intra-medullary nailing device, which, once in place with its anchors, extended securing the bone shaft, which anchors the device to cortical bone. Subsequent stabilization at both ends of the fixation device provide further strength and stress distribution by proximal and distal transfixing screws to provide axial, bending and torsional stability at both ends of the bone. The method provides for reconstructing and reinforcing bones, including diseased, osteoporotic, and fractured bones. It helps to return to early mobility and full function, with the added advantage of minimal soft tissue morbidity. The present invention is also helpful in using a design of an intramedullary nailing device due to the simplicity of the design, thus cutting costs.

BRIEF DESCRIPTION OF DRAWINGS:
[017] Reference will be made to embodiments of the invention, examples of which may be illustrated in accompanying figures. These figures are intended to be illustrative, not limiting. Although the invention is generally described in the context of these embodiments, it should be understood that it is not intended to limit the scope of the invention to these particular embodiments.
[018] FIG. 1 is a longitudinal sectional view of an expandable intramedullary nail;
[019] FIG. 2 shows a perspective view of an expandable intramedullary nail in the proximal end of the femur, with screws placed through apertures to lock the device; and
[020] FIG. 3 illustrates a perspective view of the implanted device and gripper of the device in the distal end of the femur showing the nail in an expanded position and located within the medullary cavity of a fractured bone, with screws placed through apertures to lock the device.

DETAILED DESCRIPTION OF DRAWINGS:
[021] While the present invention is described herein by way of example using embodiments and illustrative drawings, those skilled in the art will recognize that the invention is not limited to the embodiments of drawing or drawings described and are not intended to represent the scale of the various components. Further, some components that may form a part of the invention may not be illustrated in certain figures, for ease of illustration, and such omissions do not limit the embodiments outlined in any way. It should be understood that the drawings and the detailed description thereto are not intended to limit the invention to the particular form disclosed, but on the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the scope of the present invention as defined by the appended claim.
[022] As used throughout this description, the word "may" is used in a permissive sense (i.e. meaning having the potential to), rather than the mandatory sense, (i.e. meaning must). Further, the words "a" or "an" mean "at least one” and the word “plurality” means “one or more” unless otherwise mentioned. Furthermore, the terminology and phraseology used herein are solely used for descriptive purposes and should not be construed as limiting in scope. Language such as "including," "comprising," "having," "containing," or "involving," and variations thereof, is intended to be broad and encompass the subject matter listed thereafter, equivalents, and additional subject matter not recited, and is not intended to exclude other additives, components, integers, or steps. Likewise, the term "comprising" is considered synonymous with the terms "including" or "containing" for applicable legal purposes. Any discussion of documents, acts, materials, devices, articles, and the like are included in the specification solely for the purpose of providing a context for the present invention. It is not suggested or represented that any or all these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention.
[023] In this disclosure, whenever a composition or an element or a group of elements is preceded with the transitional phrase “comprising”, it is understood that we also contemplate the same composition, element, or group of elements with transitional phrases “consisting of”, “consisting”, “selected from the group of consisting of, “including”, or “is” preceding the recitation of the composition, element or group of elements and vice versa.
[024] The present invention is described hereinafter by various embodiments with reference to the accompanying drawing, wherein reference numerals used in the accompanying drawing correspond to the like elements throughout the description. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiment set forth herein. Rather, the embodiment is provided so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those skilled in the art. In the following detailed description, numeric values and ranges are provided for various aspects of the implementations described. These values and ranges are to be treated as examples only and are not intended to limit the scope of the claims. In addition, several materials are identified as suitable for various facets of the implementations. These materials are to be treated as exemplary and are not intended to limit the scope of the invention.
[025] The present invention relates to a surgical instrument, a lockable bone fixation device, particularly an instrument known as an intramedullary bone-setting nail to fix bone fractures. After the fractured bones are aligned, the nail can prevent rotation or torsion of one bone part with respect to the other, thus compressing the fractured bone portions and keeping them in proper alignment, suitable for reinforcing and/or repairing a bone. The intramedullary bone-setting nail has a sleeve capable of adapting its length once inserted within the medullary cavity of the bone. The plurality of the length of the nail is achieved by controlling a bolt which in turn inserts or retreats a screw-threaded bar passing through the hollow sheath within the medullary cavity, wherein the actuating shaft extends axially through the sleeve with a reduced diameter portion. The intramedullary bone-setting nail includes a device consisting of a plurality of circumferentially spaced radially retracted and expandable metallic elements. Movement of the parts from the retracted position to the expanded position is controlled by a dedicated bolt for controlling the radial position of the elements for individual screw-threaded bars.
[026] In the expanded position, the metallic elements as extending teeth or grippers provide evenly spaced four support points each in the outer diameter and axially spaced along the sleeve for engagement with the inner wall of the medullary cavity of the bone to secure the sleeve as an anchor, within the space of the bone. Our novel design of intramedullary bone-setting nail for the fixation of bone fractures is due to an adjustable multi-position extendable nail device holder as anchors to securely position the nail in place once deployed, consisting of a plurality of circumferentially spaced radially retracted and expandable metallic elements. Further, the design consists of a few parts which are adjusted in a short time as per requirements of the surgeon by providing flexibility and permitting surgery to be performed with a high degree of maneuverability. This invention is directed to a novel lockable bone fixation device consisting of an adjustable multi-position extendable nail device element system having the ability to compress the fractured bone portions and screw entry points comprising a plurality of apertures to further strengthen and lock the device in the proximal and distal end of the femur and keeping them in proper alignment in the desired directions and methods for using the same.
[027] The intra-medullary nailing devices are needed to allow surgeons and their patients to benefit from the safest and most effective bone healing systems without causing any stress to the patient and causing minimum loss of time and with maximum safety. Thus, a device is required to treat bone fractures which permits faster functional rehabilitation, thus avoiding the occurrence of muscle atrophy and less problem of hardware failure. We have used a method wherein the bone segments are positioned in proximity to each other to enable the intramedullary nailing device to facilitate both longitudinal curvature and transverse compression by using anchors to set in place of deployment securely. The process involves intensive reaming of the medullary cavity. It sometimes results in the weakening of the bone shaft and a reduction in the blood supply required for quick healing. The present invention relates to an intra-medullary nailing device, which, once in place with its anchors, extended securing the bone shaft, which anchors the device to cortical bone. Subsequent stabilization at both ends of the fixation device provide further strength and stress distribution by proximal and distal transfixing screws to provide axial, bending and torsional stability at both ends of the bone. The method provides for reconstructing and reinforcing bones, including diseased, osteoporotic, and fractured bones. It helps to return to early mobility and full function, with the added advantage of minimal soft tissue morbidity. The present invention is also helpful in using a novel design of an intramedullary nailing device due to the simplicity of the design, thus cutting costs.
[028] Specific requirements need to be addressed for inventing a practical multi-position novel intra-medullary nailing device consisting of a few parts adjusted quickly as per the surgeon's requirements. The technical solutions in the embodiments of the present invention have been described in the accompanying drawings.
[029] Referring to Figs. 1-3, a novel intra-medullary nailing device for the fixation of bone fractures having transverse threaded bolts in prefabricated holes in the nail at both the ends of the fixation device to provide further strength and stress distribution by proximal and distal transfixing screws to provide axial, bending and torsional stability at both ends of the femur fractures. Adequate reduction and sufficient over-reaming allow guide-wire placement 1 during reaming of femur and during nail insertion over the guide wire into the diaphyseal medullary canal while ensuring the correction of alignment by using radiographic confirmation of correct guide-wire location and direction. Entry into the bone is created with a cannulated drill inserted over the previously placed guide pin. With the fracture reduced, measure the distance from the planned nail entry site. Select a nail that extends from the entry site without protruding above the bone surface. Nail length may be critical for distal fractures. Lead screw 2 is used to move the tubular core 3 of the intramedullary bone-setting device. The tubular core of the intramedullary bone-setting device moves inside the rigid body portion 4 due to the flexible body core 5. The device consists of unique expanding grippers (6 and 7), which are designed to effectively engage the inner wall of the divergent portion of the medullary cavity of the bone after coming out of 5. There are screw entry points (8 - 9) to further strengthen and lock the device in the proximal end of femur (12) and screw entry points (10 - 11) to further strengthen and lock the device in the distal end of femur (13). Surgical technique of using the nail is optional and will change as per surgeon’s requirement to use it or not along with intramedullary bone-setting device.
[030] The present invention provides the below-mentioned technical features and advantages:
- An implantable collapsible multi-position intra-medullary nailing device has a lead screw being used to move the tubular core.
- The tubular core of the intramedullary bone-setting device moves inside the rigid body portion due to the flexible body core.
- A lead screw is operably connected to the tubular core to change the grippers from a flexible to a rigid state.
- Unique expanding grippers are designed to effectively engage the inner wall of the divergent portion of the medullary cavity of the bone after coming out of the flexible body core.
- A device with the above features and screw entry points comprising a plurality of apertures to further strengthen and lock the device in the proximal and distal end of the femur.
[031] With reference now to the drawings, and in particular to FIGS. 1 to 3 thereof, a novel method and an apparatus of an intra-medullary nailing device with variable adjustable lockable mechanisms have been described, embodying the principles and concepts of the disclosed subject matter will be described.
[032] The disclosure has been described with reference to the accompanying embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein.
[033] The foregoing description of the specific embodiments so fully revealed the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the scope of the embodiments as described herein.
, Claims:We Claim:
1) A bone fixation device, the device comprises a guide-wire placement 1, a tubular core 3 of an intramedullary bone-setting device moves inside a rigid body portion 4 due to a flexible body core 5; a lead screw 2 for moving the tubular core 3; expanding grippers 6 and 7 that effectively engages an inner wall of the divergent portion of the medullary cavity of a bone after coming out of the flexible body core 5.
2) The device as claimed in claim 1, wherein the device comprises screw entry points 8-9 to strengthen and lock the device in a proximal end of femur 12.
3) The device as claimed in claim 1, wherein the device comprises screw entry points 10 - 11 to strengthen and lock the device in the distal end of femur 13.
4) The device as claimed in claim 1, wherein adequate reduction and sufficient over-reaming allow guide-wire placement 1 during reaming of femur and during nail insertion over the guide wire into the diaphyseal medullary canal while ensuring the correction of alignment by using radiographic confirmation of correct guide-wire location and direction.
5) The device as claimed in claim 1, wherein entry into the bone is created with a cannulated drill inserted over the previously placed guide pin.
6) The device as claimed in claim 1, wherein surgical technique of using the nail is optional.