Description: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 Corporation (I) Private Limited, an Indian company of the address Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-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 implant. More particularly, the present disclosure relates to an orthopedic implant.
BACKGROUND OF INVENTION
[002] Joints may need to be replaced when they become damaged due to an injury or disease. Joint replacement surgery is considered as a treatment when the damage in a joint is beyond repair or when the joint pain or dysfunction is not alleviated by less-invasive therapies. Joint replacement surgery, also known as arthroplasty, is a procedure in an orthopedic surgery in which a dysfunctional joint surface is replaced with an orthopedic prosthesis.
[003] For instance, a joint replacement surgery includes the replacement of a ball and a bearing of the joint. Fig.1 depicts a glenohumeral joint comprising the humerus and scapula representing a ball and a bearing joint. In a ball-and-bearing joint replacement surgery, the damaged components are removed and replaced with artificial parts (prosthesis) i.e., a ball and a bearing. The ball fits snugly into the bearing, enabling articulation of the limbs.
[004] Conventional implants include a structure where, a bearing sits on a tray. The tray on which the bearing sits, replaces the head of the bone. However, improper locking of the bearing to the tray results in loose-fitting of the bearing to the tray. Loose-fitting of the bearing to the tray leads to dislocation of the implant components. This can in turn cause uneven mechanical load distribution between joints leading to the rise of several complications and diseases such as osteolysis.
[005] Hence, there is a need of an implant that can overcome the problems associated with the conventional joint replacement implants.
SUMMARY OF INVENTION
[006] The present invention relates to an implant including, a proximal end and a distal end, a bearing and a tray. The bearing includes a protruding section and a locking element. The tray is coupled to the bearing. Further, the tray includes a base and a wall. The base includes a slot. The wall surrounds the base. The thickness of the wall is non-uniform. The wall includes at least two cut-outs. The cut-outs are provided in a stepped configuration on a portion of the wall. The cut-outs are configured to mate with the locking element. The protruding section includes an asymmetrical structure configured to provide anti-rotational characteristic to the bearing.
[007] The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[008] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[009] Fig.1 depicts a perspective view of a glenohumeral joint, according to an embodiment of the present disclosure.
[0010] Fig. 2 depicts a perspective view of an orthopedic implant 100, according to an embodiment of the present disclosure.
[0011] Figs. 3a-3d depict respective perspective views of a bearing 300 of the orthopedic implant 100, according to an embodiment of the present disclosure.
[0012] Figs. 4a-4b depict respective perspective views of a tray 400, according to an embodiment of the present disclosure.
[0013] Figs. 5a-5b depict detailed views of a lock 510 and 520 between the bearing 300 and the tray 400, according to an embodiment of the present disclosure.
[0014] Fig. 5c depicts a cross-sectional assembled view of the bearing 300 and tray 400, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0015] Prior to describing the disclosure 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.
[0016] 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.
[0017] 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.
[0018] 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.
[0019] In accordance with the present disclosure, an orthopedic implant (hereinafter, an implant) is disclosed. The implant is used in various joint replacement surgeries such as, a reverse shoulder surgery. The damaged parts of a glenohumeral joint are replaced with the implant.
[0020] The tray and the bearing are locked via a secure locking mechanism defined between the two. The secure locking mechanism ensures that the tray and the bearing of the implant remain firmly in place. This reduces the risk of dislocation, enhancing the implant’s function and longevity. The secure locking mechanism further helps to distribute mechanical load evenly thus, minimizing the stress concentration. Further, the design of the implant simplifies the surgical process by cutting down surgery time and minimizing errors.
[0021] Though the locking mechanism of the present disclosure is explained with respect to a shoulder implant, it can be extended to different parts of the human body, such as a hip implant, which are within the scope of the teachings of the present disclosure.
[0022] Now referring to the figures, Fig. 2 depicts a perspective view of an implant 100. The implant 100 replaces the injured or damaged head of the humerus bone of the glenohumeral joint. The implant 100 includes a proximal end 120 and a distal end 140. The implant 100 includes a bearing 300 at the distal end 140 and a tray 400 at the proximal end 120 of the implant 100. The bearing 300 is coupled to the tray 400, which has been explained later. Details of the bearing 300 have been explained in the context of Figs 3a-3d while details of the tray 400 have been explained in the context of Fig. 4a-4b.
[0023] The bearing 300 may be made of any biocompatible poly metal material or metal. The metal that may be used in making the bearing 300 may include, without limitation, Titanium, cobalt chromium, SS 316, HNSS, etc., or a combination thereof. The poly material includes without limitation, ultra-high molecular weight polyethylene (UHMWPE), polymethyl methacrylate (PMMA), highly cross-linked polyethylene (HXLPE) including Vitamin E, polyether ether ketone (PEEK). In an exemplary embodiment, the bearing 300 is made of ultra-high molecular weight polyethylene (UHMWPE). Alternatively, the bearing 300 can be made of any poly material without any metal. The dimensions of the bearing 300 may vary according to or based upon the anatomy of the patient and/or of the patient population in consideration.
[0024] The bearing 300 includes a top surface 305 and a bottom surface 310. The top surface 305 is depicted in Fig. 3a. The bearing 300 may be a tubular structure including a slant. In an embodiment, the top surface 305 of the bearing 300 is slanted. That is, the width of the bearing 300 reduces from a first end 305a to a diametrically opposite second end 305b. In the depicted embodiment, L1 and L2 define the width of two diametrically opposite ends, the first end 305a and the second end 305b. As shown, L2 is less than L1. This slant conforms to the underlying human anatomy where the implant 100 is to be secured.
[0025] The top surface 305 of the bearing 300 may include a curvature. In an embodiment, the top surface 305 includes a concave curvature. In another embodiment, the top surface 305 includes a convex curvature. The curvature of the top surface 305 of the bearing 300 is configured to receive at least a portion of the glenoid component.
[0026] The bottom surface 310 is depicted in Figs. 3b-3d. The bottom surface 310 of the bearing 300 is configured to sit over the surface of the tray 400 of the implant 100.
[0027] The bottom surface 310 of the bearing 300 includes a protruding section 325 and a locking element 320. In an embodiment, the bottom surface 310 of the bearing 300 includes a central protruding section 325. Although it is possible that the protruding section 325 may be slightly offset from the center. The protruding section 325 extends away from the bottom surface 310 of the bearing 300 defining a specific height It is to be noted that the height of the protruding section 325 may vary, and is dependent on a patient’s anatomy. The protruding section 325 includes one of a circular, oval, sphere, or ellipse shape. The protruding section 325 is configured to sit over a base 420 of the tray 400 for effective locking of the tray 400 and the bearing 300, as described below.
[0028] The protruding section 325 is depicted in Figs. 3b-3c. The protruding section 325 includes an asymmetrical structure configured to provide anti-rotational characteristic to the bearing 300. In an embodiment, the protruding section 325 includes four sides namely, a first side 325a, a second side 325b, a third side 325c and a fourth side 325d. In an embodiment, the first side 325a is nearly U-shaped, that is, the first side 325a includes a curve. In an embodiment, the face of the first side 325a includes a vertical portion followed by a slant. That is, the face of the first side 325a includes a vertical face leading to a taper (or slant) at a predefined angle with respect to the longitudinal axis of the implant 100.
[0029] The second side 325b is positioned, opposite to the first side 325a. In an embodiment, the second side 325b is arc-shaped subtending a specific angle at the center of the protruding section 325. In an embodiment, the second side 325b of the protruding section 325 includes a tab 330 that extends beyond the wall of the second side 325b of the protruding section 325. The tab 330 may be provided at a specific height. The height of the tab 330 depends upon a patient’s anatomy. The tab 330 extends such that a hollow space 335 is defined between the bottom surface 310 of the tab 330 and the bottom surface 310 of the bearing 300. The tab 330 is configured to mate with a second sliced section 435a of the tray 400 for effective locking of the bearing 300 and the tray 400, as explained below.
[0030] The third side 325c and the fourth side 325d are spaced apart and positioned opposite to each other. The third side 325c and the fourth side 325d are sandwiched between the first side 325a and the second side 325b. The walls of the third side 325c and the fourth side 325d may be substantially perpendicular to the bottom surface 310.
[0031] The locking element 320 includes a vertical slab 340 around the circumference of the bearing 300. The vertical slab 340 extends away from the bottom surface 310, defining a specific height. It is to be noted that the height of the vertical slab 340 may vary, and is dependent on a patient’s anatomy. In an embodiment, the vertical slab 340 has a rectangular cross-section. The vertical slab 340 is configured to sit over a second cut-out 460 of the tray 400 for effective locking of the tray 400 and the bearing 300, as described below.
[0032] A horizontal slab 345 extends from a top surface of the vertical slab 340, defining a specific width. It is to be noted that the width of the horizontal slab 345 may vary, and is dependent on a patient’s anatomy. The horizontal slab 345 is placed such that, a hollow space is defined between the bottom surface of the horizontal slab 345 and the bottom surface 310 of the bearing 300. The horizontal slab 345 is configured to mate with a first cut-out 455 of the tray 400 for effective locking of the tray 400 and the bearing 300, as described below. Further, a flap 350 extends from an edge of the top surface of the horizontal slab 345, defining a specific height. Also, it is to be noted that, height of the flap 350 is dependent on a patient’s anatomy. In an embodiment, the flap 350 has a rectangular cross-section. The flap 350 is configured to fit into a slot 450 of the tray 400 for effective locking of the bearing 300 and the tray 400, as described below.
[0033] Figs. 4a-4b depict various perspective views of the tray 400. The tray 400 may be made of any biocompatible poly material or metal. The metal that may be used in making the tray 400 includes, without limitation, titanium, cobalt chromium, SS 316, HNSS, or a combination thereof. The poly material includes without limitation, titanium, cobalt chromium, and stainless steel (SS316). The poly material includes without limitation, ultra-high molecular weight polyethylene (UHMWPE), polymethyl methacrylate (PMMA), highly cross-linked polyethylene (HXLPE) including Vitamin E, PEEK etc. In an exemplary embodiment, the tray 400 is made of titanium. The dimensions of the tray 400 may vary according to or based upon the anatomy of the patient and/or of the patient population in consideration.
[0034] The tray 400 includes a top surface 410 and a bottom surface 405. The bottom surface 405 of the tray 400 towards the proximal end, may include an extension 465. The extension 465 is used to fix the implant 100 to the humerus bone of the glenohumeral joint. The extension 465 may be cylindrical, spherical, conical, circular, etc. in shape.
[0035] The top surface 410 of the tray 400 is configured to receive the bottom surface 310 of the bearing 300. The top surface 410 of the tray 400 is shown in Fig. 4a-4b. The top surface 410 of the tray 400 includes a central base 420 (hereinafter a base 420) surrounded by a wall 425 extending from the edge of the base 420. In an embodiment, the base 420 is circular. The base 420 is configured to mate with the protruding section 325 of the bearing 300 for effective locking of the bearing 300 and the tray 400, as described below.
[0036] The circumference of the wall 425 is provided with a rim. The wall 425 includes an inner surface and an outer surface. The wall 425 includes at least a first portion 430, a second portion 435 and at least one sandwiched portion 440. In an embodiment, the first portion 430 and the second portion 435 are diametrically opposite. Alternate orientations of the first portion 430 and the second portion 435 are possible and within the teachings of the present disclosure. The sandwiched portion 440 extends between the first portion 430 and the second portion 435.The wall 425 includes a non-uniform thickness . Further, the thickness of the wall 425 is non-uniform. The wall 425 may include at least two sliced portions of reduced thickness. The at least two sliced portions may be provided on an inner surface of the wall 425. The sliced portions are depicted in Fig. 4a-4b. According to an embodiment, the wall 425 of the tray 400, on its inner surface and at the first portion 430, is at least partially sliced into a slanted portion 430a (hereinafter, a first sliced portion 430a). The thickness of the first sliced portion 430a is less than the thickness of the sandwiched portion 440 of the wall 425.Similarly, the wall 425 of the tray 400, on its inner surface and at the second portion 435, is at least partially sliced into a slanted portion 435a (hereinafter, a second sliced portion 435a). The thickness of the second sliced portion 435a is less than the thickness of the sandwiched portion 440 of the wall 425.Further, the thickness of the wall 425 at the first portion 430 may be narrower. This is due to at least two cut-outs provided on the outer surface of the wall 425 at the first portion 430. Details of the cut-out are explained in detail in Fig. 4b.
[0037] The base 420 includes a slot 450 (Fig. 4a) provided near the first portion 430. The slot 450 is configured to interface with the flap 350 of the bearing 300 for effective locking of the bearing 300 and the tray 400, as described below. In the depicted embodiment, the slot 450 is in the shape of an arc. Other shapes via which the teachings of the present disclosure can be practiced, are within the scope of the present disclosure.
[0038] Fig. 4b illustrates the detailed view of the outer surface of the first portion 430 of the wall 425 including at least two cut-outs configured to mate with the respective locking elements 320. The thickness of the wall 425 at the first portion 430 is less compared to other portions of the wall 425. This is due to the first sliced portion 430a on the inner surface and the cut-out on the outer surface. The wall 425 of the first portion 430 includes a cavity 445. The cavity 445 is provided at the bottom edge of the wall 425 (that is, away from the rim). In the depicted embodiment, the cavity 445 is in the shape of an arc. Further, the cavity 445 is aligned with the slot 450. The cavity 445 is configured to provide a passage to the horizontal slab 345 and the flap 350 of the locking element 320 of the bearing 300 for effective locking of the bearing 300 and the tray 400, as described below. Other shapes via which the teachings of the present disclosure can be practiced, are within the scope of the present disclosure.
[0039] According to an embodiment, the cut-outs are provided in a stepped configuration on a portion of the wall 425 having reduced thickness. For instance, the at least one cut-out of the first portion 430 includes a first cut-out 455 and a second cut-out 460. In an embodiment, the first cut-out 455 and the second cut-out 460 are stepped. The first cut-out 455 is provided below the second cut-out 460. The first cut-out 455 is aligned with the slot 450. Further, the circumferential length of the first cut-out 455 is less than the circumferential length of the second cut-out 460. The first cut-out 455 and the second cut-out 460 as depicted, are of rectangular cross-section. Alternatively, the first cut-out 455 and the second cut-out 460 may have different cross-sections. The first cut-out 455 is configured to mate with the horizontal slab 345 of the bearing 300 for effective locking of the bearing 300 and the tray 400, as described below. Further, the second cut-out 460 is configured to mate with the vertical slab 340 of the bearing 300 for effective locking of the bearing 300 and the tray 400, as described below.
[0040] The cavity 445, the slot 450, the first cut-out 455 and the second cut-out 460 of the tray 400 and the vertical slab 340, the horizontal slab 345, the flap 350, tab 330 and the protruding section 325 of the bearing 300 may be laser cut or carved using any optimal machining process in the respective components. Alternately, these may be separate components and thereafter welded, etc.
[0041] The implant 100 includes the assembly of the bearing 300 and the tray 400. The bearing 300 of the implant 100 is placed over the tray 400 of the implant 100. The protruding section 325 at bottom surface 310of the bearing 300 sits over the base 420 of the top surface 410 of the tray 400.
[0042] The protruding section 325 of the bearing 300 slides across the base 420 of the tray 400. The tab 330 (Fig. 3d) of the second side 325b of the protruding section 325, interfaces the second sliced portion 435a of the second portion 435. Fig. 5a depicts a lock 510, of the tab 330 of the bearing 300 and the second sliced portion 435a of the tray 400.
[0043] For assembly, the flap 350 of the horizontal slab 345 of the bearing 300 passes through the cavity 445 of the tray 400. Further, the flap 350 of the bearing 300 mates with the slot 450. Fig. 5b depicts a lock 520, of the flap 350 of the bearing 300 and the slot 450 of the tray 400. The horizontal slab 345 thus sits in the first cut-out 455. The vertical slab 340 extending on both sides of the horizontal slab 345, interfaces with the second cut-out 460. The bearing 300 snap fits the tray 400. Once the bearing 300 snap fits the tray 400, the inner circumference of the vertical slab 340 of the bearing 300 interfaces with the outer circumference of the wall 425 of the first portion 430 of the tray 400. Further, locking the bearing 300 with the tray 400 of the implant 100 as shown in Fig. 5c.
[0044] The flap 350 of the bearing 300 fits into the slot 450 of the tray 400. Thus, depicting a secure locking mechanism between the bearing 300 and the tray 400 of the implant 100.
[0045] The implant 100 replaces the head of the humerus bone. A diseased portion of the humerus bone of the glenohumeral joint is removed. The head of the humerus bone, after removing the diseased part is reamed. The extension 465 of the tray 400 is placed in the reamed portion of the humeral bone. The extension 465 may be cemented with the bone to ensure a secure fit. Thus, replacing the head of the humerus bone of the glenohumeral joint with the implant 100.
[0046] It is to be noted that the aforesaid description details various cut-outs/projections, slots/grooves etc. which function in pair. Thus, the disposition and shape of two corresponding mating component is complementary. Any alteration of one component is to be replicated to the corresponding mating component.
[0047] 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) comprising:
a. a proximal end (120) and a distal end (140);
b. a bearing (300) includes a protruding section (325) and a locking element (320); and
c. a tray (400) coupled to the bearing (300), the tray (400) includes:
i. a base (420) including a slot (450); and
ii. a wall (425) surrounding the base (420), the wall (425) includes at least two cut-outs configured to mate with the locking element (320);
wherein the protruding section (325) includes an asymmetrical structure configured to provide anti-rotational characteristic to the bearing (300);
wherein thickness of the wall (425) is non-uniform;
wherein the cut-outs are provided in a stepped configuration on a portion of the wall (425).
2. The implant (100) as claimed in claim 1 wherein, at least one of the, bearing (300) and the tray (400) are made from one of a biocompatible metal or poly material.
3. The implant (100) as claimed in claim 1 wherein, the bearing (300) is a tubular structure including a slant.
4. The implant (100) as claimed in claim 1 wherein, a top surface (305) of the bearing (300) includes a curvature.
5. The implant (100) as claimed in claim 1 wherein, the bottom surface (405) of the tray (400) includes an extension (465).
6. The implant (100) as claimed in claim 1 wherein, the protruding section (325) includes one of a circular, oval, sphere, or ellipse shape.
7. The implant (100) as claimed in claim 1 wherein, the protruding section (325) includes a U-shaped first side (325a) having a vertical face followed by a slant.
8. The implant (100) as claimed in claim 1 wherein, the protruding section (325) includes a tab (330) that extends beyond the protruding section (325).
9. The implant (100) as claimed in claim 1 wherein, the locking element (320) includes:
a. a vertical slab (340);
b. a horizontal slab (345) extending from a top surface of the vertical slab (340); and
c. a flap (350) extending from an edge of the horizontal slab (345).
10. The implant (100) as claimed in claim 1 wherein, the slot (450) is in the shape of an arc.
11. The implant (100) as claimed in claim 1 wherein, the wall (425) includes a cavity (445) configured to provide a passage for the horizontal slab (345) and the flap (350) of the locking element (320).
12. The implant (100) as claimed in claim 1 wherein, the wall (425) includes at least two sliced portions of reduced thickness.
13. The implant (100) as claimed in claim 9 wherein, the at least two sliced portions are provided on an inner surface of the wall (425).
14. The implant (100) as claimed in claim 1 wherein, the cut-outs are provided in a stepped configuration on a portion of the wall (425) having reduced thickness.