DESC:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

1. TITLE OF THE INVENTION:
ORTHOPEDIC IMPLANT
2. APPLICANT:
Meril Healthcare Pvt. Ltd., an Indian company of the Survey No. 135/139, Bilakhia House, Muktanand Marg, Chala, Vapi- 396191, Gujarat, India.

The following specification particularly describes the invention and the manner in which it is to be performed:

FIELD OF INVENTION
[001] The present disclosure relates to medical implants. More particularly, the present disclosure pertains to an orthopedic implant.
BACKGROUND OF INVENTION
[002] Orthopedic implants are medical devices designed to either replace or support damaged joints or bones, playing a crucial role in restoring mobility, alleviating pain, and improving the overall quality of life for patients with musculoskeletal disorders or traumatic injuries. These devices include a wide range of structures such as artificial joints (hip, knee, shoulder), bone plates, screws, rods, and other fixation devices. They are used in various surgical procedures like joint replacements, fracture fixation, and bone reconstruction, with the goal of mimicking the mechanical function and structural integrity of natural bone and joint tissues.
[003] Traditional fixation systems, which include bone plates and multiple bone screws, have been widely used in orthopedic surgeries. These systems generally involve securing one or more bone plates to a fractured or weakened bone using a set of bone screws. However, this conventional approach presents several limitations. For instance, the bone screws commonly used are straight and are inserted along a linear path, which can limit their ability to provide adequate fixation over a longer section of bone. The anatomical structure of bones often features curves and contours, which causes challenges in achieving strong, stable fixation. The straight bone screws may rotate or twist due to the curved nature of bones, which can result in loosening or weakening of the fixation over time. This instability may cause the implant to shift or dislocate, leading to implant failure and significant discomfort or pain for the patient.
[004] Another significant disadvantage of traditional bone fixation systems is the requirement for large incisions during a surgery to implant a bone plate. The bone plates, which are often long and rigid, need to be fully exposed during the procedure to allow for proper placement and fixation. This results in extensive incisions that match the size of the bone plates, which leads to more trauma at the surgical site. Larger incisions not only increase the complexity and duration of the surgery but also lead to longer recovery times for patients, as they must heal from both the internal fixation and the external tissue damage caused by the incision. Additionally, extensive soft tissue damage can increase the risk of post-operative complications such as infection and delayed healing.
[005] In cases where patients have multiple fractures, the limitations of conventional implants become even more pronounced. Treating multiple fractures often requires the use of multiple bone plates and screws, each of which must be separately secured. This can lead to longer and more complex surgeries, as each implant requires precise placement, and large incisions must be made to accommodate each fixation site. The complexity of the surgical procedure is further compounded by the risk of improper alignment or fixation, which could lead to further complications during the patient’s recovery.
[006] Therefore, there is a need for an orthopedic implant that overcomes the drawbacks of conventional fixation devices.
SUMMARY OF INVENTION
[007] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
[008] The present disclosure relates to an orthopedic implant. The orthopedic implant includes a guide rod, a head, a plurality of articulating balls and a plurality of coupling elements. The guide rod includes a first threaded portion provided at a front end of the guide rod and having first threads. The guide rod includes a second threaded portion provided at a rear end of the guide rod and has second threads. The head includes a hole having inner threads configured to engage with at least a portion of the first threads of the guide rod. Each articulating ball has a hole and a curved surface. Each coupling element has a hole, an inner face, a front curved profile, and a rear curved profile. The plurality of articulating balls and the plurality of coupling elements are alternately disposed on the guide rod.
BRIEF DESCRIPTION OF DRAWINGS
[009] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. To illustrate the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[0010] Fig. 1 illustrates a schematic cross-sectional view of an implant 100, in accordance with an embodiment of the present disclosure.
[0011] Fig. 1a illustrates a schematic cross-sectional view of the implant 100 in a bending position, in accordance with an embodiment of the present disclosure.
[0012] Fig. 2 illustrates an isometric view of a guide sheath 110, in accordance with an embodiment of the present disclosure.
[0013] Fig. 2a illustrates a schematic exploded view of the implant 100, in accordance with an embodiment of the present disclosure.
[0014] Fig. 3 illustrates an isometric view of a sub-assembly 120 of the implant 100, in accordance with an embodiment of the present disclosure.
[0015] Fig. 3a illustrates an isometric view of a guide rod 121 of the implant 100, in accordance with an embodiment of the present disclosure.
[0016] Fig. 3b illustrates an isometric view of a head 123 of the implant 100, in accordance with an embodiment of the present disclosure.
[0017] Fig. 3c illustrates a schematic diagram of a front coupling element 125 of the implant 100, in accordance with an embodiment of the present disclosure.
[0018] Fig. 3d illustrates an isometric view of an articulating ball 127 of the implant 100, in accordance with an embodiment of the present disclosure.
[0019] Fig. 3e illustrates an isometric view of a coupling element 129 of the implant 100, in accordance with an embodiment of the present disclosure.
[0020] Fig. 3f illustrates perspective views of a rear coupling element 131 of the implant 100, in accordance with an embodiment of the present disclosure.
[0021] Fig. 3g illustrates isometric views of a first occluder 133 of the implant 100, in accordance with an embodiment of the present disclosure.
[0022] Fig. 3h illustrates isometric views of a second occluder 135 of the implant 100, in accordance with an embodiment of the present disclosure.
[0023] Fig. 4 illustrates a flowchart of a method 400 for assembling the implant 100, in accordance with an embodiment of the present disclosure.
[0024] Fig. 4a illustrates the implant 100 implanted in a femur of a patient, in accordance with an embodiment of the present disclosure.
[0025] Fig. 4b illustrates the implant 100 implanted in a pelvic bone of a patient, in accordance with an embodiment of the present disclosure.
[0026] Fig. 5 illustrates a schematic cross-sectional view of an implant 200, in accordance with an embodiment of the present disclosure.
[0027] Fig. 5a illustrates a cross-sectional view of the implant 200 in a bending position, in accordance with an embodiment of the present disclosure.
[0028] Fig. 5b illustrates an isometric view of a guide rod 221 of the implant 200, in accordance with an embodiment of the present disclosure.
[0029] Fig. 5c illustrates an isometric view of a head 223 of the implant 200, in accordance with an embodiment of the present disclosure.
[0030] Fig. 5d illustrates isometric views of a front coupling element 225 of the implant 200, in accordance with an embodiment of the present disclosure.
[0031] Figs. 5e and 5f illustrate multiple isometric views of an articulating ball 227 of the implant 200, in accordance with an embodiment of the present disclosure.
[0032] Figs. 5g and 5h illustrate multiple isometric views of a coupling element 229 of the implant 200, in accordance with an embodiment of the present disclosure.
[0033] Fig. 5i illustrates perspective views of a rear coupling element 231 of the implant 200, in accordance with an embodiment of the present disclosure.
[0034] Fig. 5j illustrates an isometric view of an occluder 233 of the implant 200, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0035] Prior to describing the invention in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have a property of, or the like. Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases.
[0036] Reference throughout this specification to “one embodiment,” “an embodiment,” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment, but mean “one or more but not all embodiments” unless expressly specified otherwise. The terms “including,” “comprising,” “having,” and variations thereof mean “including but not limited to” unless expressly specified otherwise. An enumerated listing of items does not imply that any or all of the items are mutually exclusive and/or mutually inclusive, unless expressly specified otherwise. The terms “a,” “an,” and “the” also refer to “one or more” unless expressly specified otherwise.
[0037] Although the operations of exemplary embodiments of the disclosed method may be described in a particular, sequential order for convenient presentation, it should be understood that the disclosed embodiments can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular embodiment are not limited to that embodiment, and may be applied to any embodiment disclosed herein. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses.
[0038] Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[0039] An embodiment of the present disclosure relates to an orthopedic implant (or implant) used to fix fracture(s) in any bone(s), such as, without limitation, the tibia, femur, humerus, radius, wrist, etc. The implant can also serve as a replacement for a nailing system conventionally used for fracture fixation. The implant is flexible and is able to follow a curved path. The flexibility enables the implant to adapt more closely to the anatomical structure of the patient, facilitating a more precise and tailored fixation approach compared to conventional implants. Such adaptability enhances the implant's effectiveness and overall outcomes in orthopedic surgical procedures. Unlike conventional implants that require long incisions concerning the bone plates, the implant disclosed in the present disclosure requires only minimally invasive surgical procedures, leading to improved patient recovery times. Therefore, the proposed implant is easier to implant than the conventional implants. Due to its flexible structure, the implant proposed in the present disclosure better adapts to the curved trajectory of the bone canal. Further, the implant can traverse complex paths reamed according to multiple fractures and can hold multiple bone fragments together to promote healing.
[0040] In an embodiment, the implant includes a guide rod, a head, a plurality of articulating balls, a plurality of coupling elements, a front coupling element, a rear coupling element, and at least one occluder. The guide rod is elongated and flexible. The guide rod is coupled with the head, the plurality of articulating balls, the plurality of coupling elements, the front coupling element, the rear coupling element, the at least one occluder to form a sub-assembly.
[0041] According to an embodiment of the present disclosure, the head is coupled to a frontend of the guide rod. The front coupling element couples with the head and the guide rod. The plurality of articulating balls and the plurality of coupling elements are alternately disposed over the guide rod. A first of the articulating balls is disposed towards rear end of the front coupling element and couples with the corresponding coupling element. The rear coupling element is disposed towards a rear end of the last articulating balls and couples with the last articulating balls. The rear coupling element is disposed over the guide rod. The at least one occluder is coupled with the rear coupling element and the guide rod, thereby forming a sub-assembly. The implant optionally includes a guide sheath. The guide sheath is flexible and has a tubular structure. The sub-assembly is inserted into the guide sheath from a rear end of the guide sheath and is coupled with the guide sheath at a frontend of the guide sheath.
[0042] Now referring to the figures, Fig. 1 illustrates a schematic cross-sectional view of an orthopedic implant 100 (or implant 100) according to an embodiment, and Fig. 1a depicts a sectional view of the implant 100 tracing a curved path, according to an embodiment. The implant 100 includes a front end 100a and a rear end 100b. The implant 100 includes a guide rod 121, a head 123, a front coupling element 125, a plurality of articulating balls 127 (for example, articulating balls 127c-127f), a plurality of coupling elements 129 (for example, coupling elements 129e-129g), a rear coupling element 131, and at least one occluder. In an embodiment, the at least one occluder includes a first occluder 133, and a second occluder 135. Further, the head 123, the front coupling element 125, the plurality of articulating balls 127 (or the articulating balls 127), the plurality of coupling elements 129 (or the coupling elements 129), the rear coupling element 131, the first occluder 133, and the second occluder 135 are assembled on the guide rod 121 to form a sub-assembly 120. The sub-assembly 120 is flexible and is able to traverse curved paths through the bone (as depicted in Fig. 1a).
[0043] In an embodiment, the implant 100 may include a guide sheath 110 adapted to be assembled with the sub-assembly 120. Fig. 2 illustrates an isometric view of the guide sheath 110 according to an embodiment and Fig. 2a depicts an exploded view of the implant 100 having the guide sheath 110, according to an embodiment. The guide sheath 110 has a front end 110a and a rear end 110b. In an embodiment, the guide sheath 110 is cylindrical in shape having a taper towards the front end 110a of the guide sheath 110. The tapered shape of the guide sheath 110 towards the front end 110a facilitates easier entry of the guide sheath 110 into the bone canal.
[0044] The guide sheath 110 includes a locking member 110d at the front end 110a. The guide sheath 110 (as depicted in Fig. 2) is flexible and may have a tubular structure enclosing a cavity (not shown). The cavity extends from the rear end 110b to the front end 110a of the guide sheath 110 along the length of the guide sheath 110 configured to receive at least the articulating balls 127 and the coupling elements 129. In an embodiment, the cavity of the guide sheath 110 is configured to receive the sub-assembly 120. Further, the guide sheath 110 includes a plurality of holes 110c disposed of on an outer surface 110e of the guide sheath 110. The plurality of holes 110c provided on the outer surface 110e allows bone growth due to osseointegration. Growth of bone in the plurality of holes 110c enhances the fixation of the implant 100. The plurality of holes 110c may have a shape such as without limitation, square, rectangle, diamond, triangle, circle, ellipse, oval, etc. The plurality of holes 110c may have the same or different shapes and sizes. In an exemplary embodiment, the plurality of holes 110c have a square shape and are of the same size.
[0045] Further, the guide sheath 110 is inserted into the bone canal such that the outer surface 110e of the guide sheath 110 mates with the bone canal. The guide sheath 110 facilitates the sub-assembly 120 to trace curved pathways through the bone.
[0046] Furthermore, the guide sheath 110 has a front opening 110f at the front end 110a and a rear opening 110g at the rear end 110b. The rear opening 110g of the guide sheath 110 allows the sub-assembly 120 to be inserted into the cavity of the guide sheath 110. The front opening 110f allows a portion of the head 123 of the sub-assembly 120 to pass through the guide sheath 110. The guide sheath 110 is coupled with the head 123. The locking member 110d is provided around the circumference of the front opening 110f of the guide sheath 110 and is adapted to lock the sub-assembly 120 with the guide sheath 110. In an embodiment, the locking member 110d is in the form of a rim.
[0047] In an embodiment, the guide sheath 110 may be made of a biocompatible material, such as, without limitation, titanium, cobalt chromium, SS316, etc. In an example implementation, the guide sheath 110 is made of titanium. The dimensions of the guide sheath 110 may be chosen depending on the size of the bone where the implant 100 is to be implanted and the degree of fixation needed.
[0048] Fig. 3 illustrates an isometric view of the sub-assembly 120 of the implant 100, in accordance with an embodiment. The sub-assembly 120 includes a combination of the plurality of articulating balls 127 (e.g., the articulating balls 127c-127f), the plurality of coupling elements 129 (e.g., the coupling elements 129e-129g), the head 123, the front coupling element 125, the rear coupling element 131, the first occluder 133 and the second occluder 135 assembled on the guide rod 121. The plurality of articulating balls 127 and the plurality of coupling elements 129 are alternatively disposed along the length of a portion of the guide rod 121 and locked by the front coupling element 125, the rear coupling element 131, the first occluder 133 and the second occluder 135 to retain the plurality of articulating balls 127 and the plurality of coupling elements 129 on the guide rod 121.
[0049] Fig. 3a illustrates an isometric view of the guide rod 121, in accordance with an embodiment. The guide rod 121 is flexible to adapt to the created pathway during the surgical implantation procedure. The guide rod 121 may bend and traverse through the pathway of the bone canal which is in the curved shape. The plurality of articulating balls 127 and the plurality of coupling elements 129 are alternately disposed on the guide rod 121. The guide rod 121 has a front end 121a and a rear end 121b. The guide rod 121 includes first threads 121c, second threads 121d, a front face 121f, and a rear face (not shown). The guide rod 121 has a first threaded portion 121g provided at the front end 121a of the guide rod 121 and a second threaded portion 121k provided at the rear end 121b of the guide rod 121. The first threads 121c are provided on the first threaded portion 121g of the guide rod 121 and the second threads 121d are provided on the second threaded portion 121k of the guide rod 121.
[0050] In an embodiment, the guide rod 121 includes a non-threaded portion 121h disposed between the first threaded portion 121g and the second threaded portion 121k and has a surface 121e. The plurality of articulating balls 127 and the plurality of coupling elements 129 are alternately disposed on the non-threaded portion 121h of the guide rod 121. In an embodiment, the first threaded portion 121g has a larger diameter than the non-threaded portion 121h and the second threaded portion 121k. This helps in preventing any unwanted movement and/or dislocation of the articulating balls 127 and the coupling elements 129 towards the front end 121a of the guide rod 121. In another embodiment, the first threaded portion 121g may have the same or smaller diameter than the non-threaded portion 121h and the second threaded portion 121k. The non-threaded portion 121h and the second threaded portion 121k may have the same diameter.
[0051] The guide rod 121 may be made of titanium, cobalt chromium, SS316, UHMWPE, PMMA, HXLPE including vitamin E, etc., or any other biocompatible metallic or biocompatible polymeric material. In an example implementation, the guide rod 121 is made of titanium. In an embodiment, the dimensions of the guide rod 121 may be chosen depending upon the size of the bone where the implant 100 is to be implanted and the degree of fixation needed.
[0052] Referring to Fig. 3b illustrates an isometric view of the head 123, according to an embodiment. The head 123 includes a front end 123a and a rear end 123b. The head 123 may have a tubular structure with a taper from the rear end 123b to the front end 123a, i.e., the diameter of the head 123 decreases from the rear end 123b to the front end 123a. The tapered shape of the head 123 enables easy penetration of the implant 100 into the bone canal during the surgical implantation procedure. In an exemplary embodiment, the head 123 may have a frustum shape. The head 123 has a groove 123c provided circumferentially on an outer surface of the head 123 at a pre-defined distance from the front end 123a dividing the head 123 into a front portion 123a1 and a rear portion 123b1. In an exemplary embodiment, the groove 123c may be provided at approximately half the length of the head 123.
[0053] The groove 123c of the head 123 engages with the locking member 110d of the guide sheath 110 to lock the sub-assembly 120 with the guide sheath 110. The width of the locking member 110d corresponds with the width of the groove 123c. Further, the front portion 123a1 of the head 123 extends through the front opening 110f of the guide sheath 110 to facilitate engagement of the groove 123c with the locking member 110d of the guide sheath 110 to retain the sub-assembly 120. The front portion 123a1 of the head 123 may be solid and the rear portion 123b1 of the head 123 may be hollow. The rear portion 123b1 of the head 123 has a hole 123d extending from a rear surface 123f of the head 123 along at least a partial length of the rear portion 123b1 of the head 123 and ending at an ending face 123d1.
[0054] In an embodiment, the hole 123d may have a corresponding profile to the first threaded portion 121g of the guide rod 121. The diameter of the hole 123d corresponds to the diameter of the first threaded portion 121g of the guide rod 121. The hole 123d has inner threads 123e. The inner threads 123e are complementary to the first threads 121c. The inner threads 123e of the head 123 are configured to engage with at least a portion of the first threads 121c of the guide rod 121 to form a threaded coupling. Further, the front face 121f mates with the ending face 123d1 (as shown in Fig. 1). It should be understood that other coupling mechanisms for coupling the head 123 with the guide rod 121, for example, tapered fit, snap fit, etc. are also within the scope of the present disclosure.
[0055] The head 123 may be made of a biocompatible material such as, without limitation, titanium, cobalt chromium, SS316, etc. In an example implementation, the head 123 is made of titanium. The dimensions of the head 123 may be chosen depending upon the size of the bone where the implant 100 is to be implanted and the degree of fixation needed.
[0056] Referring to Fig. 3c depicts an isometric view of the front coupling element 125, according to an embodiment. The front coupling element 125 may have a shape, such as, without limitation cylindrical, circular, ring-shaped, etc. In an exemplary embodiment, the front coupling element 125 has a ring shape. The front coupling element 125 has a plane surface 125a at a front end of the front coupling element 125, a curved surface 125b at a rear end of the front coupling element 125, and inner threads 125c provided on the inner perimeter of the front coupling element 125. Further, the front coupling element 125 has an internal diameter corresponding to the diameter of the first threaded portion 121g of the guide rod 121. The inner threads 125c are configured to engage with a rear portion of the first threads 121c of the first threaded portion 121g of the guide rod 121. The inner threads 125c are complementary to the first threads 121c of the first threaded portion 121g. The plane surface 125a is configured to mate with the rear surface 123f of the head 123.
[0057] The front coupling element 125 is coupled to the first threaded portion 121g of the guide rod 121. The inner threads 125c of the front coupling element 125 are coupled with a rear portion of the first threads 121c of the first threaded portion 121g of the guide rod 121. Other coupling mechanisms, for example, tapered fit, snap fit, etc. used for coupling the front coupling element 125 with the guide rod 121 are also within the scope of the present disclosure. Furthermore, the front coupling element 125 and the head 123 are coupled on the guide rod 121 such that the plane surface 125a of the front coupling element 125 and the rear surface 123f of the head 123 are butted together as shown in Fig. 1. The front coupling element 125 and the head 123 are rotated in an opposite direction to each other so that they are butted together. The front coupling element 125 is also coupled to a corresponding one of the plurality of articulating balls 127 (e.g., a first articulating ball 127c in the depicted embodiment).
[0058] The front coupling element 125 may be made of a biocompatible material such as, without limitation, titanium, cobalt chromium, SS316, etc. In an example implementation, the front coupling element 125 is made of titanium. The dimensions of the front coupling element 125 may be chosen depending on the size of the bone where the implant 100 is to be implanted and the degree of fixation needed.
[0059] The plurality of articulating balls 127 are disposed axially over the surface 121e of the guide rod 121. Fig. 3d depicts an isometric view of the one articulating ball 127 of the plurality of articulating balls 127, according to an embodiment. The articulating ball 127 has a hole 127a provided centrally and extending along an axis corresponding to a longitudinal axis of the guide rod 121. Further, the articulating ball 127 may be spherical having a curved surface 127b as shown in Fig. 3d. The hole 127a defines an inner face 127a1 of the articulating ball 127. The hole 127a may be a cylindrical, through-hole. The diameter of the hole 127a corresponds to the diameter of the non-threaded portion 121h of the guide rod 121. The articulating ball 127 is inserted from the rear end 121b of the guide rod 121 and is disposed over the surface 121e of the guide rod 121. The inner face 127a1 is configured to mate with the surface 121e of the guide rod 121.
[0060] The plurality of articulating balls 127 may be made of any suitable material such as, without limitation, titanium, cobalt chromium, SS316, etc. In an example implementation, the plurality of articulating balls 127 is made of titanium. The dimensions of the plurality of articulating balls 127 may be chosen depending upon the size of the bone where the implant 100 is to be implanted and the degree of fixation needed.
[0061] In an embodiment, the plurality of coupling elements 129 is disposed axially over the surface 121e of the guide rod 121. Fig. 3e depicts multiple isometric views of one coupling element 129 of the plurality of coupling elements 129, according to an embodiment. The coupling element 129 may have a shape, such as without limitation, cylindrical, circular, ring-shaped, etc. In an example implementation, the coupling element 129 has a ring shape. Each coupling element 129 has a front curved profile 129a provided at a front end of the coupling element 129, a rear curved profile 129b provided at a rear end of the coupling element 129, and a hole 129c provided centrally and defining an inner face 129d of the coupling element 129 (as shown in Fig. 3e). The ring shape of the coupling element 129 facilitates the front curved profile 129a and the rear curved profile 129b fitting and gliding over the curved surface 127b of the articulating balls 127 more smoothly and helps in achieving a curved profile of the implant 100 more easily. The diameter of the hole 129c corresponds to the diameter of the non-threaded portion 121h of the guide rod 121. The inner face 129d is configured to mate with the surface 121e of the guide rod 121.
[0062] Each coupling element 129 is disposed between and coupled with two articulating balls 127. The front curved profile 129a and the rear curved profile 129b of the coupling element 129 are configured to engage with the corresponding curved surface 127b of the two articulating balls 127 (as depicted in Fig. 1). For example, the front curved profile 129a of each coupling element 129 articulates with a rear part of the curved surface 127b of a front articulating ball 127 disposed at the front end of the coupling 129 and the rear curved profile 129b of the coupling element 129 articulates with a front part of the curved surface 127b of a rear articulating ball 127 disposed at the rear end of the coupling element 129.
[0063] The plurality of coupling elements 129 may be made of any suitable material such as, without limitation, titanium, cobalt chromium, SS316, etc. In an example implementation, the plurality of coupling elements 129 is made of titanium. The dimensions of the plurality of coupling element 129 may be chosen depending upon the size of the bone where the implant 100 is to be implanted and the degree of fixation needed. According to an embodiment, the outer diameter of the plurality of coupling elements 129 may be smaller than the diameter of the plurality of articulating balls 127. This ensures that the outer surface of the coupling element 129 does not interfere when the implant 100 is taking a curved path.
[0064] The plurality of articulating balls 127 and the plurality of coupling elements 129 are alternately disposed over the guide rod 121 such that each pair of the articulating ball 127 and coupling element 129 forms a ball-socket joint. In an exemplary embodiment, the plurality of coupling element 129 has three coupling elements 129e – 129g, and the plurality of articulating ball 127 has four articulating balls 127c – 127f (as depicted in Fig. 1). The number of articulating balls 127 and the coupling elements 129 shown herein are merely exemplary. It should be appreciated that any number of articulating balls 127 and coupling elements 129 may be used without deviating from the scope of the present disclosure. The number of articulating balls 127 and the number of coupling elements 129 are chosen as per the desired length of the implant 100, which in turn depends upon the amount of fixation needed.
[0065] Fig. 3f illustrates multiple perspective views of the rear coupling element 131, according to an embodiment. The rear coupling element 131 is disclosed at a rear end of the last articulating ball 127f. The rear coupling element 131 may have a shape, such as, without limitation cylindrical, circular, ring-shaped, etc. In an embodiment, the rear coupling element 131 has a cylindrical shape having a hole 131c and an outer surface 131e. The hole 131c may have an inner surface 131c1 and a step-profile 131p. The step-profile 131p extends from a rear end of the rear coupling element 131 towards a front end of the rear coupling element 131 at a partial length of the rear coupling element 131. The step-profile 131p may have a first surface 131b, and a second surface 131d. The first surface 131b may be a straight surface parallel to a longitudinal axis of the rear coupling element 131 and the second surface 131d may be slanted inwards. The rear coupling element 131 may have a front curved surface 131a at the front end of the rear coupling element 131. The rear coupling element 131 may have a rear end surface 131h and a rear curved surface 131f at the rear end of the rear coupling element 131. Further, the rear coupling element 131 may have a plurality of slots 131g disposed at the rear end surface 131h extend along the length of the step-profile 131p of the rear coupling element 131. In an embodiment, the plurality of slots 131g are utilized to hold the rear coupling element 131 during the coupling of the at least one occluder (explained later). The first surface 131b and the rear curved surface 131f are used to guide the at least one occluder during the assembly of the implant 100 as explained later.
[0066] In an embodiment, the rear coupling element 131 has an internal diameter larger than the diameter of the guide rod 121. The rear coupling element 131 is inserted from the rear end 121b of the guide rod 121. The outer surface 131e is in interference with and mates with an inner surface (not shown) of the guide sheath 110 as shown in Fig. 1. The front curved surface 131a of the rear coupling element 131 articulates with a rear portion of the curved surface 127b of the last of the articulating balls 127 (i.e., the last articulating ball 127f in the depicted embodiment). Further, the rear coupling element 131 may reside over the second threads 121d of the guide rod 121 such that there is a gap between the inner surface 131c1 of the hole 131c and the second threads 121d as shown in Fig. 1.
[0067] In an embodiment, the rear coupling element 131 may be made of any suitable material such as, without limitation, titanium, cobalt chromium, SS316, etc. In an example implementation, the rear coupling element 131 is made of titanium.
[0068] The at least one occluder of the implant 100 is coupled to the rear coupling element 131 and the second threaded portion 121k of the guide rod 121, retaining the plurality of articulating balls 127 and the plurality of coupling elements 129 on the guide rod 121. Fig. 3g depicts the first occluder 133 according to an embodiment. In an exemplary embodiment, the first occluder 133 has a cylindrical portion 133a provided at a front end of the first occluder 133 and a disc portion 133b provided at a rear end of the first occluder 133. Other functionally equivalent shapes of first occluder 133 are within the scope of the teachings of the present disclosure. The first occluder 133 may have other equivalent shapes that are within the scope of the teachings of the present invention. The first occluder 133 is coupled to the rear end 121b of the guide rod 121 and the rear end of the rear coupling element 131 to retain the plurality of coupling elements 129 and the plurality of articulating ball 127 on the guide rod 121 to form the sub-assembly 120.
[0069] In an embodiment, the cylindrical portion 133a includes a hole 133a3 having inner threads 133a1 configured to engage with a rear portion of the second threads 121d of the guide rod 121 such that at least two or more threads of the second threads 121d at the rear end 121b of the guide rod 121 extend out of the hole 133a3 towards the rear end of the first occluder 133. The cylindrical portion 133a has an outer surface 133a2 configured to mate with the inner surface 131c1 of the rear coupling element 131 during assembly. The disc portion 133b has a rear surface 133b1 including a slot having a surface 133b2 and an extended surface 133b3. The inner threads 133a1 are disposed along the length of the cylindrical portion 133a of the first occluder 133. The surface 133b2 may be polygonal, circular, etc. In the depicted embodiment, the surface 133b2 is hexagonal. The disc portion 133b has an outer surface 133b4. The extended surface 133b3 is a front surface of the disc portion 133b of the first occluder 133. Further, the hole 133a3 of the cylindrical portion 133a has an internal diameter corresponding to the diameter of the second threaded portion 121k of the guide rod 121. The first occluder 133 is screwed at the rear end 121b of the guide rod 121 to retain the plurality of coupling 129, the rear coupling element 131, and the plurality of articulating ball 127.
[0070] In an embodiment, the first occluder 133 engages with the rear coupling element 131 and the guide rod 121 as follows: the first occluder 133 is inserted into the rear coupling element 131 from the rear end of the rear coupling element 131. The first surface 131b of the rear coupling element 131 guides the outer surface 133b4 of the disc portion 133b of the first occluder 133. The inner surface 131c1 guides and mates with the outer surface 133a2. The slot of the first occluder 133 is used to hold the first occluder 133 during the coupling of the first occluder 133 with the rear coupling element 131. For example, a surgical device (not shown) is placed at the surface 133b2 and is used to rotate the first occluder 133 to couple with the guide rod 121 and the rear coupling element 131. For example, the surgical instrument is rotated until the inner threads 133a1 of the first occluder 133 engage with the rear portion of the second threads 121d of the guide rod 121 such that the at least two or more threads of the second threads 121d extend out of the hole 133a3 towards the rear end of the first occluder 133, and the extended surface 133b3 mates with the second surface 131d of the step-profile 131p of the rear coupling element 131. The surgical device may include, without limitation, an Allen key, a screwdriver (e.g., a simple hex screwdriver), a smart instrument (e.g., a limiting torque wrench), etc.
[0071] Fig. 3h depicts the second occluder 135 according to an embodiment. In an exemplary embodiment, the second occluder 135 has a cylindrical portion 135a and a disc portion 135b. Other functionally equivalent shapes of second occluder 135, are within the scope of the teachings of the present invention. The second occluder 135 may have other equivalent shapes that are within the scope of the teachings of the present invention. The second occluder 135 may be coupled to the rear end 121b of the guide rod 121 and the rear end of the first occluder 133 to retain the plurality of coupling 129 and the plurality of articulating ball 127 on the guide rod 121 to form the sub-assembly 120.
[0072] In an embodiment, the cylindrical portion 135a includes a hole 135a3 having inner threads 135a1 configured to engage with the at least two or more threads of the second threads 121d of the guide rod 121. The cylindrical portion 135a has an outer surface 135a2 configured to mate with the first surface 131b of the rear coupling element 131 during assembly. The disc portion 133b has a rear surface 135b1 including a slot having a surface 135b2 and an extended surface 135b3. The inner threads 135a1 may be disposed along the length of the cylindrical portion 135a of the second occluder 135. The surface 135b2 may be polygonal, circular, etc. In the depicted embodiment, the surface 135b2 is hexagonal. The extended surface 135b3 is a front surface of the disc portion 135b of the second occluder 135. Further, the inner threads 135a1 of the cylindrical portion 135a have an internal diameter corresponding to the diameter of the second threaded portion 121k of the guide rod 121. The second occluder 135 is screwed at the rear end 121b of the guide rod 121 to retain the plurality of coupling 129, the rear coupling element 131, and the plurality of articulating ball 127.
[0073] In an embodiment, the second occluder 135 engages with the rear coupling element 131 and the guide rod 121 as follows: the second occluder 135 is inserted into the rear coupling element 131 from the rear end of the rear coupling element 131. The first surface 131b of the rear coupling element 131 guides and mates with the outer surface 135a2 of the cylindrical portion 135a of the second occluder 135. The slot of the second occluder 135 is used to hold the second occluder 135 during the coupling of the second occluder 135 with the rear coupling element 131. A surgical device (not shown) is placed at the surface 135b2 and is used to rotate the second occluder 135 to couple with the guide rod 121 and the rear coupling element 131. For example, the surgical instrument is rotated until the inner threads 135a1 of the second occluder 135 engage with the at least two or more threads of the second threads 121d of the guide rod 121, and the extended surface 135b3 mates with the rear curved surface 131f of the rear coupling element 131. The surgical device may include, without limitation, an Allen key, a screwdriver (e.g., a simple hex screwdriver), a smart instrument (e.g., a limiting torque wrench), etc.
[0074] In an embodiment, the first occluder 133 and the second occluder 135 work in conjunction to provide enhanced stability to the implant 100 compared to the use of a single occluder. This dual-occluder arrangement ensures improved positional retention and minimizes the likelihood of displacement or misalignment during operation. By distributing forces more evenly, the two occluders (namely, the first occluder 133 and the second occluder 135) can effectively counteract external pressures or stresses, making the implant 100 more reliable and robust in various applications. Furthermore, the synergy between the first occluder 133 and the second occluder 135 may also contribute to enhanced performance and extended operational lifespan of the implant 100.
[0075] Fig. 4 illustrates a flowchart of a method 400 for assembling the implant 100, according to an embodiment. At step 401, the head 123 is coupled to the front end 121a of the guide rod 121 using the corresponding internal threaded hole 123d. The inner threads 123e of the head 123 engage with the corresponding threads (i.e., the front portion) of the first threads 121c of the guide rod 121 as shown in Fig. 1.
[0076] At step 403, the front coupling element 125 is coupled to the guide rod 121 using, for example, a threaded coupling. In an embodiment, the inner threads 125c of the front coupling element 125 engage with the corresponding threads (i.e., the rear portion) of the first threads 121c of the guide rod 121, and the rear surface 123f mates with the plane surface 125a as shown in Fig. 1. The front coupling element 125 and the head 123 may be rotated in opposite directions so that the rear surface 123f and the plane surface 125a are butted together.
[0077] At step 405, the plurality of articulating balls 127 and the plurality of coupling elements 129 are alternately disposed over the guide rod 121 as shown in Fig. 1. The plurality of articulating balls 127 and the plurality of coupling elements 129 may inserted alternatively from the rear end 121b of the guide rod 121 and coupled with each other as explained below.
[0078] For example, the first articulating ball 127c is inserted over the guide rod 121 from the rear end 121b of the guide rod 121. A front part of the curved surface 127b of the first articulating ball 127c articulates with the curved surface 125b of the front coupling element 125. The inner face 127a1 of the first articulating ball 127c mates with the surface 121e of the guide rod 121.
[0079] The coupling element 129e is then inserted over the guide rod 121 from the rear end 121b of the guide rod 121. The first curved profile 129a of the coupling element 129e articulates with a rear part of the curved surface 127b of the first articulating ball 127c. The inner face 129d of the coupling element 129e mates with the surface 121e of the guide rod 121.
[0080] The articulating ball 127d is then inserted over the guide rod 121 from the rear end 121b of the guide rod 121. The front part of the curved surface 127b of the articulating ball 127d articulates with the rear curved profile 129b of the coupling element 129e. The inner face 127a1 of the articulating ball 127d mates the surface 121e of the guide rod 121.
[0081] The coupling element 129f is inserted over the guide rod 121 from the rear end 121b of the guide rod 121. The front curved profile 129a of the coupling element 129f articulates with the rear part of the curved surface 127b of the articulating ball 127d. The inner face 129d of the coupling element 129f mates with the surface 121e of the guide rod 121.
[0082] The articulating ball 127e and the coupling element 129g are inserted over the guide rod 121 and are coupled in a similar manner. The last articulating ball 127f is then inserted over the guide rod 121 from the rear end 121b of the guide rod 121. The front part of the curved surface 127b of the last articulating ball 127f articulates with the rear curved profile 129b of the coupling element 129g. The inner face 127a1 of the last articulating ball 127f mates the surface 121e. In an exemplary embodiment, the arrangement of the articulating ball 127 and the coupling element 129 may be arranged differently within the scope of the present disclosure.
[0083] At step 407, the rear coupling element 131 is inserted over the guide rod 121 from the rear end 121b of the guide rod 121. The front curved surface 131a of the rear coupling element 131 articulates with the rear part of the curved surface 127b of the last articulating ball 127f.
[0084] At step 409, the first occluder 133 and the second occluder 135 are coupled with the rear coupling element 131 and the guide rod 121. In an embodiment, the first occluder 133 and the second occluder 135 are inserted from the rear end 121b of the guide rod 121 and coupled to the rear coupling element 131 and the guide rod 121 as explained earlier. This forms the sub-assembly 120.
[0085] At step 411, the sub-assembly 120 is coupled to the guide sheath 110. For example, the front portion of the sub-assembly 120 is inserted into the cavity of the guide sheath 110 from the rear end 110b of the guide sheath 110. The locking member 110d engages the groove 123c, thereby assembling the implant 100.
[0086] According to an embodiment, during a surgical procedure for implanting the implant 100, an incision is made at a target location. A suitable guidewire is inserted into a bone and pushed to create a pathway depending on the location and degree of fixation needed. The pathway can be curved. When the guidewire has taken a shape corresponding to the pathway, a reamer (e.g., a flexible canulated reamer) is inserted into the bone. The reamer reams the pathway traced by the guidewire to create a canal of a suitable diameter. The reamer and the guidewire are removed. The guide sheath 110 is inserted into the canal. The sub-assembly 120 is then inserted into the guide sheath 110 and coupled with the guide sheath 110. Alternatively, when the guide sheath 110 is not present, the sub-assembly 120 is inserted into the canal to fix the joint or fracture. Figs. 4a and 4b illustrate the implant 100 implanted in the femur or the pelvic bone, respectively, of a patient. As can be seen, the number of articulating balls 127 and the coupling elements 129 are different in both cases and are chosen based upon the fixation required. Further, the implant 100 is able to match the curved profile of the femur and the pelvic bone as shown.
[0087] Fig. 5 illustrates a schematic cross-section view of an orthopedic implant 200 (or implant 200) and Fig. 5a illustrates a cross-section view of the implant 200 in a bending position, in accordance with another embodiment of the present disclosure. The implant 200 has a rear end 200a and a front end 200b. The implant 200 includes a guide rod 221, a head 223, a front coupling element 225, a plurality of articulating balls 227 (e.g., articulating balls 227d – 227n), a plurality of coupling elements 229 (e.g., coupling elements 229e – 229n), a rear coupling element 231, and at least one occluder. In the depicted embodiment, the at least one occluder includes a single occluder 233. The guide rod 221, the head 223, the front coupling element 225, the plurality of articulating balls 227, the plurality of coupling elements 229, the rear coupling element 231, and the occluder 233 are assembled to form a sub-assembly 220. Optionally, the implant 200 includes a guide sheath 210. The guide sheath 210 is assembled with the sub-assembly 220 during a surgical implantation procedure. The implant 200 is flexible and is able to traverse curved paths through the bone. Fig. 5a depicts a sectional view of the implant 200 tracing a curved path.
[0088] In an embodiment, the guide sheath 210 is structurally and functionally similar to the guide sheath 110. Details of the guide sheath 210 can be referred to from Fig. 2 and are not repeated here for the sake of brevity. The guide sheath 210 is inserted into the bone canal. In an embodiment, the guide sheath 210 is assembled with the sub-assembly 220 during the surgical procedure. The plurality of articulating balls 227 and the plurality of coupling elements 229 are alternately disposed over the guide rod 221 and locked by the front coupling element 225, the rear coupling element 231 and the occluder 233 to retain the plurality of articulating balls 227 and the plurality of coupling elements 229 on the guide rod 221. The sub-assembly 220 is guided into a cavity of the guide sheath 210 and assembled with the guide sheath 210 in a similar manner as described earlier.
[0089] Fig. 5b illustrates an isometric view of the guide rod 221, in accordance with an embodiment. The articulating balls 227 and the coupling elements 229 are alternately disposed on the guide rod 221. It may be understood that in various embodiments, the implant 100 may include the guide rod 221 instead of the guide rod 121 and similarly, in various embodiments, the implant 200 may include the guide rod 121 instead of the guide rod 221 without deviating from the scope of the present disclosure. In an embodiment, the guide rod 221 has a front end 221a and a rear end 221b. The guide rod 221 includes a first threaded portion 221g provided at the front end 221a, a second threaded portion 221k provided at the rear end 221b of the guide rod 221 and a rear face 221f. First threads 221c are provided on the first threaded portion 221g of the guide rod 221 and second threads 221d are provided on the second threaded portion 221k of the guide rod 221.
[0090] In an embodiment, the guide rod 221 includes a non-threaded portion 221h disposed between the first threaded portion 221g and the second threaded portion 221k and has a surface 221e. The plurality of articulating balls 227 and the plurality of coupling elements 229 are alternately disposed on the non-threaded portion 221h of the guide rod 221.
[0091] In an embodiment, the guide rod 221 includes at least one support coil 221e1 disposed over the non-threaded portion 221h of the guide rod 221 to form a surface 221e. The at least one support coil 221e1 may be formed by coiling a respective wire over the non-threaded portion 221h. The at least one support coil 221e1 improves the flexibility and load distribution of the guide rod 121. The plurality support coil 221e1 may be made of a biocompatible material such as, without limitation, titanium alloy, carbon fiber reinforced plastic, etc. In an example implementation, the at least one support coil 221e1 is made of titanium. The guide rod 221 is flexible, allowing it to bend and traverse through the trajectory of the bone canal during surgical implantation. The first threaded portion 221g may have a larger diameter than the non-threaded portion 221h and the second threaded portion 221k of the guide rod 221. In another embodiment, the first threaded portion 221g may have the same or smaller diameter as compared to the non-threaded portion 221h and the second threaded portion 221k of the guide rod 221.
[0092] The guide rod 221 may be made of titanium, cobalt chromium, SS316, UHMWPE, PMMA, HXLPE including vitamin E, etc., or any other biocompatible metallic or biocompatible polymeric material. In an example implementation, the guide rod 221 is made of titanium. In an embodiment, the dimensions of the guide rod 221 may be chosen depending upon the size of the bone where the implant 100 is to be implanted and the degree of fixation needed.
[0093] Fig. 5c depicts an isometric view of the head 223 according to an embodiment. The head 223 is coupled to the first threaded portion 221g of the guide rod 221. It may be understood that in various embodiments, the implant 100 may include the head 223 instead of the head 123 and similarly, in various embodiments, the implant 200 may include the head 123 instead of the head 223 without deviating from the scope of the present disclosure. The head 223 has a rear end 223b and a front end 223a. The head 223 may have a tubular shape with a taper along the length of the head 223 from the front end 223a to the rear end 223b such that the diameter of the head 223 gradually decreases from the rear end 223b to the front end 223a. The tapered shape of the head 123 enables easy penetration of the implant 200 into a bone canal of a patient during the surgical implantation procedure.
[0094] In an exemplary embodiment, the head 223 has a frustum shape. The head 223 included a groove 223c provided circumferentially on an outer surface of the head 223 at a pre-defined distance from the rear end 223b (shown in Fig. 5c) dividing the head 223 into a front portion 223a1 and a rear portion 223b1. The groove 223c engages with a locking member (not shown) of the guide sheath 210 to lock the sub-assembly 220 with the guide sheath 210. The front portion 223a1 extends through a front opening (not shown) of the guide sheath 210. The width of the groove 223c corresponds with the width of the locking member of the guide sheath 210.
[0095] In an embodiment, the head 223 has outer threads 223g disposed on the outer surface of the head 223. The outer threads 223g may be provided from the front end 223a for at least partial length of the front portion 223a1 of the head 223. In an embodiment, the outer threads 223g are disposed along the entire length of the front portion 223a1 and the groove 223 is provided at the position where the outer threads 223g end. The outer threads 223g facilitate easy insertion of the implant 200 into the bone canal during the surgical implantation procedure. Since the outer threads 223g touch the bone to provide a snug fit, it may be preferrable to have the outer threads 223g as long as possible and accordingly, the groove 223c may be provided closer to the rear end 223b as compared to the position of the groove 123c of the head 123 of the implant 100.
[0096] In an embodiment, the front portion 223a1 of the head 223 may be solid and the rear portion 223b1 of the head 223 may be hollow. The rear portion 223b1 of the head 223 includes a hole 223d extending inwardly from a rear surface 223f of the head 223 along at least a partial length of the rear portion 223b1 of the head 223 and ending at an ending face 223d1. The hole 223d may have a shape corresponding to the shape of the first threaded portion 221g of the guide rod 221. In an embodiment, the hole 223d is cylindrical. The diameter of the hole 223d corresponds to the diameter of the first threaded portion 221g. The hole 223d includes inner threads 223e that are complementary to the first threads 221c of the guide rod 221.
[0097] In an embodiment, the inner threads 223e of the head 223 are configured to engage with at least a portion (e.g., a front portion) of the first threads 221c of the guide rod 221, and the front face of the guide rod 221 mates with the ending face 223d1. Other coupling mechanisms for coupling the head 223 with the guide rod 221 are also within the scope of the present disclosure.
[0098] In an embodiment, the head 223 may be made of a biocompatible material such as, without limitation, titanium, cobalt chromium, SS316 etc. In an example implementation, the head 223 is made of titanium.
[0099] Fig. 5d illustrates multiple perspective views of a front coupling element 225 of the implant 200, in accordance with an embodiment. In an embodiment, the front coupling element 225 is structurally and functionally similar to the front coupling element 125. Details of the front coupling element 225 can be referred to from Fig. 3c and are not repeated here for the sake of brevity. In an embodiment, the front coupling element 225 includes a plane surface 225a at a front end of the front coupling element 225, a curved surface 225b at a rear end of the front coupling element 225, and inner threads 225c provided on an inner perimeter of the front coupling element 225. The plane surface 225a, the curved surface 225b and the inner threads 225c are similar, structurally and functionally, to the plane surface 125a, the curved surface 125b and the inner threads 125c, respectively, of the front coupling element 125. The front coupling element 225 may be coupled to the head 223 and the guide rod 221 in a similar manner as described in reference to the front coupling element 125.
[00100] The plurality of articulating balls 227 may be disposed axially over the surface 221e of the guide rod 221. Fig. 5e and 5f depict multiple isometric views of one articulating ball 227 of the plurality of articulating balls 227, according to various embodiments. The articulating ball 227 may be generally spherical with flat surfaces at a rear and a front end of the articulating ball 227 and have a hole 227a provided centrally and extending along an axis corresponding to a longitudinal axis of the guide rod 221 defining an inner face 227a1, and a curved surface 227b. The hole 227a is a cylindrical, through-hole. The diameter of the hole 227a corresponds to the diameter of the surface 221e of the guide rod 221.
[00101] According to an embodiment, the articulating ball 227 includes a depressed portion 227c3 at each of the rear and front end of the articulating ball 227. Each depressed portion 227c3 defines a curved profile 227c4. The depressed portion 227c3 and the curved profile 227c4 results in a more continuous articulating surface, preventing any sharp edges.
[00102] In an embodiment, each articulating ball 227 may include a plurality of first slots 227c1 disposed on the curved surface 227b at a front end of the articulating ball 227 and a plurality of second slots 227c2 disposed on the curved surface 227b at a rear end of the articulating ball 227. The flat surfaces at the front and the rear end of the articulating ball 127 provide for a gap between the plurality of first slots 227c1 as well as between the plurality of second slots 227c2. Such a gap facilitates easy rotation of the articulating balls 227 and the coupling elements 229. The plurality of first slots 227c1 and the plurality of second slots 227c2 are disposed symmetrically with respect to the hole 227a on the lateral sides of the articulating ball 227 (e.g., on opposite sides of the depressed portion 227c3). The plurality of first slots 227c1 and the plurality of second slots 227c2 may have the same dimensions. The plurality of first slots 227c1 and the plurality of second slots 227c2 may have the same orientation (e.g., horizontal as shown in Fig. 5e, or vertical) or may have different orientations. For example, the plurality of first slots 227c1 may be oriented horizontally and the plurality of second slots 227c2 may be oriented vertically as shown in Fig. 5f. Such a difference in the orientation of the plurality of first slots 227c1 and the plurality of second slots 227c2 provides more degrees of freedom for each articulating ball 227, which helps in pivoting the implant 200 at any given articulating 227 depending upon the profile of the bone. In an example implementation, the plurality of first slots 227c1 and the plurality of second slots 227c2 include two slots each. It should be understood though that the plurality of first slots 227c1 and the plurality of second slots 227c2 may have more than two slots.
[00103] In an embodiment, the plurality of articulating balls 227 is inserted from the rear end 221b of the guide rod 221 and is disposed over the surface 221e of the guide rod 221. Each articulating ball 227 (except the first and the last of the plurality of articulating balls 227, namely, the articulating ball 227d and the articulating ball 227n, respectively) couples with two coupling elements 229. The first articulating ball 227d is coupled with the front coupling element 225 at the front end of the first articulating ball 227d. The last articulating ball 227n is coupled with the rear coupling element 231 at the rear end of the last articulating ball 227n.
[00104] In an embodiment, the plurality of articulating balls 227 may be made of a biocompatible material, such as, without limitation, titanium, cobalt chromium, SS316, etc. In an example implementation, the plurality of articulating balls 227 is made of titanium.
[00105] The plurality of coupling elements 229 disposed axially over the surface 221e of the guide rod 221, alternately with the plurality of articulating balls 227. Figs. 5g and 5h depict multiple isometric views of one coupling element 229 of the plurality of coupling elements 229, in accordance with embodiment. Each coupling element 229 may have a shape, such as, without limitation, cylindrical, circular, ring-shaped, etc. In an example implementation, each coupling element 229 has a cylindrical shape. Each coupling element 229 has a front curved profile 229a at a front end of the coupling element 229, a rear curved profile 229b at the rear end of the coupling element 229, an outer surface 229d1, and a hole 229c provided centrally and defining an inner face 229d.
[00106] In an embodiment, the coupling element 229 may further include a plurality of first teeth 229e1 and a plurality of second teeth 229e2. The plurality of second teeth 229e2 are disposed on the front curved profile 229a and the plurality of first teeth 229e1 are disposed on the rear curved profile 229b. The plurality of first teeth 229e1 and the plurality of second teeth 229e2 are disposed laterally and symmetrically with respect to the hole 229c. Each of the plurality of first teeth 229e1 is configured to engage and move linearly within a corresponding first slot 227c1 of the articulating ball 227. Similarly, each of the plurality of second teeth 229e2 is configured to engage and move linearly within a corresponding second slot 227c2 of the articulating ball 227. The orientation of each of the plurality of first teeth 229e1 and each of the plurality of second teeth 229e2 aligns with the orientation of the corresponding first slot 227c1 and the second slot 227c2, respectively. For example, the plurality of first teeth 229e1 and the plurality of second teeth 229e2 have the same orientation (e.g., vertically oriented) as shown in Fig. 5g or may have different orientation. For example, the plurality of second teeth 229e2 are vertically aligned and the plurality of first teeth 229e1 are horizontally aligned as shown in Fig. 5h. The number of first teeth 229e1 and the second teeth 229e2 correspond to the number of first slots 227c1 and the second slots 227c2, respectively.
[00107] Further, the diameter of the hole 229c corresponds to the diameter of the surface 221e guide rod 221. The inner face 229d of the hole 229c mates with the surface 221e of the guide rod 221. Each coupling element 229 is coupled with of the two articulating balls 227 of the plurality of articulating balls 227. For example, the front curved profile 229a of each coupling element 229 articulates with a rear part of the curved surface 227b of a front articulating ball 227 disposed at the front end of the coupling element 229. In this case, each of the plurality of second teeth 229e2 engage with the corresponding second slot 227c2 of the front articulating ball 227. Similarly, the rear curved profile 229b of the coupling element 229 articulates with a front part of the curved surface 227b of a rear articulating ball 227 disposed at the rear end of the coupling element 229, and each of the plurality of first teeth 229e1 engage with the corresponding first slot 227c1 of the rear articulating ball 227.
[00108] In an embodiment, the plurality of second coupling elements 229 may be made of any suitable material such as, without limitation, titanium, cobalt chromium, SS316 etc. In an example implementation, the plurality of second coupling elements 229 is made of titanium.
[00109] The articulating ball 227 and the coupling element 229 may be alternately disposed over the guide rod 221 as shown in Fig. 5. Each pair of the articulating ball 227 and the coupling element 229 may be engaged in a gear mechanism (via the first slots 227c1, the second slots 227c2 and the corresponding first teeth 229e1 and the corresponding second teeth 229e2). Due to the gear mechanism, any circular motion experienced by any component of the sub-assembly 220 because of the curved path, is transferred to successive components. This helps in a better load distribution along the implant 200.
[00110] Further, the first articulating ball 227d is inserted over the guide rod 221 from the rear end 221b of the guide rod 221. A front part of the curved surface 227b of the first articulating ball 227d articulates with the curved surface 225b of the front coupling element 225. The inner face 227a1 of the first articulating ball 227d mates with the surface 221e of the guide rod 221.
[00111] The coupling element 229e is inserted over the guide rod 221 from the rear end 221b of the guide rod 221. The first curved profile 229a of the coupling element 229 articulates with the rear part of the curved surface 227b of the first articulating ball 227d. Further, the second teeth 229e2 on the first curved profile 229a engages with the corresponding to second slots 227c2 of the first articulating ball 227d. The inner face 229d of the hole 229c mates with the surface 221e of the guide rod 221.
[00112] The articulating ball 227e is then inserted over the guide rod 221 from the rear end 221b of the guide rod 221. The front part of the curved surface 227b of the articulating ball 227e articulates with the rear curved profile 229b of the coupling element 229e. Further, the first slots 227c1 of the first articulating ball 227d engages with the corresponding the first teeth 229e1 of the coupling element 229e. The inner face 227a1 of the articulating ball 227e mates with the surface 221e of the guide rod 221. Further, the coupling elements 229f – 229n and the articulating balls 227e – 227n are alternately coupled in a similar manner as described above.
[00113] The last articulating ball 227n is inserted over the guide rod 221 from the rear end 221b of the guide rod 221. The front part of the curved surface 227b of the last articulating ball 227n articulates with the rear curved profile 229b of the coupling element 229n. Further, the first teeth 229e1 on the rear curved changed 229b of the coupling element 229n engages with the corresponding first slots 227c1 of the last articulating ball 227n. The inner face 227a1 of the articulating ball 227m mates the surface 221e.
[00114] Though, in the depicted embodiment, the implant 200 includes eleven articulating balls 227d – 227n and ten coupling elements 229e – 229n. It should be appreciated that any number of articulating balls 227 and the coupling elements 229 may be used without deviating from the scope of the present disclosure. The number of articulating balls 227 and the coupling elements 229 may be chosen based upon a desired length of the implant 200 according to needs of a patient.
[00115] Fig. 5i illustrates multiple perspective views of the rear coupling element 231 of the implant 200, in accordance with an embodiment. The rear coupling element 231 may have a shape, such as, without limitation cylindrical, circular, ring-shaped, etc. In an exemplary embodiment, the rear coupling element 231 has a cylindrical shape having a hole 231c and an outer surface 231e. The hole 131c may have an inner surface 231c1 and a step-profile 231p. The step-profile 231p extends from a rear end of the rear coupling element 231 towards a front end of the rear coupling element 231 at a partial length of the rear coupling element 231. The step-profile 231p may have a first surface 231b, and a second surface 231d. The first surface 231b may be a straight surface parallel to a longitudinal axis of the rear coupling element 231 and the second surface 231d may be slanted inwards. The rear coupling element 231 may have a front curved surface 231a at the front end of the rear coupling element 231 and a rear end surface 231h at the rear end of the rear coupling element 231. Further, the rear coupling element 231 may have a plurality of slots 231g disposed at the rear end surface 231h and extend along the length of the rear coupling element 231. In an embodiment, the plurality of slots 231g are utilized to hold the rear coupling element 231 during the coupling of the at least one occluder 233 (explained later). The first surface 231b guides the at least one occluder during the assembly of the implant 200 as explained later.
[00116] In an embodiment, the rear coupling element 231 has an internal diameter larger than the diameter of the guide rod 221. The rear coupling element 231 is inserted from the rear end 221b of the guide rod 221. The outer surface 231e is in interference with and mates with an inner surface (not shown) of the guide sheath 210 as shown in Fig. 1. The front curved surface 231a of the rear coupling element 231 articulates with a rear portion of the curved surface 227b of the last of the articulating balls 227 (i.e., the last articulating ball 227f in the depicted embodiment). Further, the rear coupling element 231 may reside over the second threads 221d of the guide rod 221 such that there is a gap between the inner surface 231c1 of the hole 231c and the second threads 221d as shown in Fig. 1.
[00117] In an embodiment, the rear coupling element 231 may be made of any suitable material such as, without limitation, titanium, cobalt chromium, SS316, etc. In an example implementation, the rear coupling element 231 is made of titanium.
[00118] The at least one occluder of the implant 200 is coupled to the rear coupling element 231 and the second threaded portion 221k of the guide rod 221, retaining the plurality of articulating balls 227 and the plurality of coupling elements 229 on the guide rod 121. Referring to Fig. 5j illustrates multiple isometric views of the occluder 233, according to an embodiment. It should be understood that in various embodiment, the implant 100 may include the rear coupling element 231 and the occluder 233 instead of the rear coupling element 131, the first occluder 133, and the second occluder 135, and similarly, in various embodiments, the implant 200 may include the rear coupling element 131, the first occluder 133 and the second occluder 135 instead of the rear coupling element 231 and the occluder 233. The occluder 233 is coupled to the rear end 221b of the guide rod 221 and the rear coupling element 231 to retain the plurality of coupling elements 229 and the plurality of articulating ball 227 on the guide rod 221 to form the sub-assembly 220. In an embodiment, the occluder 233 has a cylindrical portion 233a provided at a front end of the occluder 233 and a disc portion 233b provided at a rear end of the occluder 233. The occluder 233 may have other equivalent shapes that are within the scope of the teachings of the present invention.
[00119] In an embodiment, the cylindrical portion 233a includes a hole 233a3 having inner threads 233a1 configured to couple with a rear portion of the second threads 221d of the guide rod 221 and an outer surface 233a2. The disc portion 233b has a rear surface 233b1 including a slot having a surface 233b2 and an extended surface 233b3. The surface 233b2 may be polygonal, circular, etc. In the depicted embodiment, the surface 233b2 is hexagonal. The extended surface 233b3 is a front surface of the disc portion 233b of the occluder 233. Further, the inner threads 233a1 of the occluder 233 have an internal diameter corresponding to the diameter of the second threaded portion 221k of the guide rod 221. The occluder 233 is screwed at the rear end 221b of the guide rod 221 to retain the plurality of coupling elements 229, the rear coupling element 231, and the plurality of articulating balls 227.
[00120] In an embodiment, the occluder 233 engages with the rear coupling element 231 and the guide rod 221 as follows: the occluder 233 is inserted into the rear coupling element 231 from the rear end of the rear coupling element 131. The first surface 231b guides the outer surface 233a2 of the cylindrical portion 233a of the occluder 233. The slot of the occluder 233 is used hold the occluder 233 during the coupling of the occluder 233 with the rear coupling element 231. A surgical device (not shown) is placed at the surface 233b2 and is used to rotate the occluder 233 to couple with the guide rod 221 and the rear coupling element 231. For example, the surgical instrument is rotated until the inner threads 233a1 of the occluder 233 engage with a rear portion of the second threads 221d of the guide rod 221, the outer surface 233a2 of the cylindrical portion 233a mates with the inner surface 231c1 of the hole 231c of the rear coupling element 231, and the extended surface 233b3 of the disc portion 233b of the occluder 233 mates with the second surface 231d of the step-profile 231p of the rear coupling element 231. Further, the rear surface 233b1 of the occluder 233 is in flush with the rear end surface 231h of the rear coupling element 231, which in turn is in flush with a rear face (not shown) of the guide sheath 210. The surgical device may include, without limitation, an Allen key, a screwdriver (e.g., a simple hex screwdriver), a smart instrument (e.g., a limiting torque wrench), etc.
[00121] In an embodiment, a method to assemble the implant 200 is similar to the method 400 of assembling the implant 100 and is not repeated for the sake of brevity. The implant 200 may be implanted using a similar procedure as described in connection with the implant 100. Further, it would be readily apparent to a person skilled in the art that one or more components of the implant 200 may be replaced by corresponding components of the implant 100 and vice versa, without deviating from the scope of the present disclosure.
[00122] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. ,CLAIMS:WE CLAIM:
1. An implant (100, 200) comprising:
a. a guide rod (121, 221) comprising:
i. a first threaded portion (121g, 221g) provided at a front end (121a, 221a) of the guide rod (121, 221) and having first threads (121c, 221c);
ii. a second threaded portion (121k, 221k) provided at a rear end (121b, 221b) of the guide rod (121, 221) and having second threads (121d, 221d);
b. a head (123, 223) comprising a hole (123d, 223d) having inner threads (123e, 223e) configured to engage with at least a portion of the first threads (121c, 221c) of the guide rod (121, 221);
c. a plurality of articulating balls (127, 227), each articulating ball (127, 227) having a hole (127a, 227a) and a curved surface (127b, 227b); and
d. a plurality of coupling elements (129, 229), each coupling element (129, 229) having a hole (129c, 229c), an inner face (129d, 229d), a front curved profile (129a, 229a), and a rear curved profile (129b, 229b);
e. wherein the plurality of articulating balls (127, 227) and the plurality of coupling elements (129, 229) are alternately disposed on the guide rod (121, 221).
2. The implant (100, 200) as claimed in claim 1, wherein the guide rod (121, 221) comprises a non-threaded portion (121h, 221h) disposed between the first threaded portion (121g, 221g) of the guide rod (121, 221) and the second threaded portion (121k, 221k) of the guide rod (121, 221) and having a surface (121e, 221e), wherein the plurality of articulating balls (127,227) and the plurality of coupling elements (129,229) are alternately disposed on the non-threaded portion (121h, 221h) of the guide rod (121, 221).
3. The implant (100, 200) as claimed in claim 2, wherein the hole (127a, 227a) of each articulating ball (127, 227) defines an inner face (127a1, 227a1) configured to mate with the surface (121e, 221e) of the guide rod (121, 221) and the hole (129c, 229c) of each coupling element (129, 229) defines an inner face (129d, 229d) configured to mate with the surface (121e, 221e) of the guide rod (121, 221).
4. The implant (100, 200) as claimed in claim 2, wherein the guide rod (221) comprises a plurality of support coils (221e1) coiled over the non-threaded portion (221h) of the guide rod (221).
5. The implant (100, 200) as claimed in claim 1, wherein the head (223) comprises outer threads (223g) disposed of on an outer surface of the head (223).
6. The implant (100, 200) as claimed in claim 1, wherein,
a. the front curved profile (129a, 229a) of each coupling element (129, 229) is configured to articulate with a rear part of the curved surface (127b, 227b) of a front articulating ball (127, 227) disposed at a front end of the coupling element (129, 229);
b. the rear curved profile (129b, 229b) of each coupling element (129, 229) is configured to articulate with a front part of the curved surface (127b, 227b) of a rear articulating ball (127, 227) disposed at a rear end of the coupling element (129, 229).
7. The implant (100, 200) as claimed in claim 1, wherein
a. each of the plurality of articulating balls (227) comprises:
i. a plurality of first slots (227c1) provided at a front end of the articulating ball (227); and
ii. a plurality of second slots (227c2) provided at a rear end of the articulating ball (227).
b. each plurality of coupling elements (229) comprises:
i. a plurality of first teeth (229e1) disposed on the rear curved profile (229b), each of the plurality of first teeth (229e1) configured to engage with a corresponding first slot (227c1) of the plurality of first slots (227c1) of a rear articulating ball (227) disposed at a rear end of the coupling element (229); and
ii. a plurality of second teeth (229e2) disposed on the front curved profile (229a), each of the plurality of second teeth (229e2) configured to engage with a corresponding second slot (227c2) of the plurality of second slots (227c2) of a front articulating ball (227) disposed at a front end of the coupling element (229).
8. The implant (100, 200) as claimed in claim 1, wherein the implant (100, 200) comprises a front coupling element (125, 225) coupled to the first threaded portion (121g, 221g) of the guide rod (121, 221), the front coupling element (125, 225) comprises:
a. a plane surface (125a, 225a) provided at a front end of the front coupling element (125, 225) and configured to mate with a rear surface (123f, 223f) of the head (123, 223);
b. a curved surface (125b, 225b) provided at a rear end of the front coupling element (125, 225) and articulating with a front part of the curved surface (127b, 227b) of a first articulating ball (127c, 227d) of the plurality of articulating balls (127, 227); and
c. inner threads (125c, 225c) provided on an inner perimeter of the front coupling element (125, 225) and configured to engage with a rear portion of the first threads (121c, 221c) of the first threaded portion (121g, 221g) of the guide rod (121, 221).
9. The implant (100, 200) as claimed in claim 1, wherein the implant (100, 200) comprises:
a. a rear coupling element (131, 231) disposed of at a rear end of a last articulating ball (127f, 227n) of the plurality of articulating balls (127, 227), the rear coupling element (131, 231) comprising a front curved surface (131a, 231a) provided at a front end of the rear coupling element (131, 231) and configured to articulate with a rear part of the curved surface (127b, 227b) of the last articulating ball (127f, 227n); and
b. at least one occluder coupled to the rear coupling element (131, 231) and the second threaded portion (121k, 221k) of the guide rod (121, 221), retaining the plurality of articulating balls (127, 227) and the plurality of coupling elements (129, 229) on the guide rod (121, 221).
10. The implant (100, 200) as claimed in claim 9, wherein the at least one occluder comprises:
a. a first occluder (133) comprising;
i. a cylindrical portion (133a) having a hole (133a3) with inner threads (133a1) configured to engage with a rear portion of the second threads (121d) of the guide rod (121) and an outer surface (133a2), wherein at least two or more threads of the second threads (121d) extend out of the hole (133a3) towards a rear end of the first occluder (133); and
ii. a disc portion (133b) having a rear surface (133b1) including a slot having a surface (133b2) and an extended surface (133b3);
b. a second occluder (135) comprising:
i. a cylindrical portion (135a) having a hole (135a3) with inner threads (135a1) configured to couple with the two or more threads of the second threads (121d) of the guide rod (121) and an outer surface (135a2); and
ii. a disc portion (135b) having a rear surface (133b1) with a slot having a surface (133b2) and an extended surface (133b3).
11. The implant (100, 200) as claimed in claim 9, wherein the at least one occluder comprises:
c. an occluder (233) comprising;
i. a cylindrical portion (233a) having a hole (233a3) with inner threads (233a1) configured to couple with a rear portion of the second threads (221d) of the guide rod (221) and an outer surface (233a2); and
ii. a disc portion (233b) having a rear surface (233b1) with a slot having a surface (233b2) and an extended surface (233b3).
12. The implant (100, 200) as claimed in claim 1, wherein the implant (100, 200) comprises a guide sheath (110, 210) coupled with the head (123, 223), the guide sheath (110, 210) comprising a cavity extending along a length of the guide sheath (110, 210) and configured to receive at least the plurality of articulating balls (127, 227) and the plurality of coupling elements (129, 229).
13. The implant (100, 200) as claimed in claim 12, wherein the cavity of the guide sheath (110, 210) is configured to receive a front coupling element (125, 225), the plurality of articulating balls (127, 227), the plurality of coupling elements (129, 229), a rear coupling element (131, 231) and at least one occluder.
14. The implant (100, 200) as claimed in claim 12, wherein:
a. the guide sheath (110, 210) comprises a front opening (110f) provided at a front end (110a,) of the guide sheath (110, 210) and a locking member (110d) provided around a circumference of the front opening (110f); and
b. the head (123) comprises a groove (123c, 223c) provided circumferentially on an outer surface of the head (123, 223), defining a rear portion (123b1, 223b1) residing within the cavity of the guide sheath (110, 210) and a front portion (123a1, 223a1) extending through the front opening (110f), the groove (123c, 223c) configured to engage with the locking member (110d) of the guide sheath (110, 210), locking the head (123, 223) with the guide sheath (110, 210).
15. The implant (100, 200) as claimed in claim 12, wherein the guide sheath (110, 210) comprises a plurality of holes (110c) provided on an outer surface (110e) of the guide sheath (110, 210).