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 discloses an implant, including a proximal end and a distal end, a bearing and a tray. Further the bearing includes, a protruding section having a peripheral edge and two or more legs. The two or more legs are provided at the peripheral edge of the protruding section. Each of the legs includes a bed and a slot. The bed is configured with a closed edge and an open edge. The open edge defines a groove.
[007] The tray is coupled to the bearing. The tray includes a base, a wall, two or more vertical slabs, two or more flange, and a tab. The wall extends from the base. Also, the two or more vertical slabs are provided on the base. Each of the flanges extend from the respective vertical slabs. Further, the two or more flanges are configured to mate with the grooves of the respective legs. The tab is provided with each of the flanges. The tabs are configured to be locked with the slots.
[008] 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
[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. 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.
[0010] Fig. 1 depicts a glenohumeral joint, according to an embodiment of the present disclosure.
[0011] Fig. 2 depicts a perspective view of an orthopedic implant 100, according to an embodiment of the present disclosure.
[0012] Fig. 3 depicts a perspective view of a bearing 200, according to an embodiment of the present disclosure.
[0013] Fig. 4 depicts a perspective view of a bottom surface 220 of the bearing 200, according to an embodiment of the present disclosure.
[0014] Fig. 5 depicts a perspective view of a tray 300, according to an embodiment of the present disclosure.
[0015] Fig. 6a depicts a detailed view of a press fit lock 600 between the slot 225 in the bearing 200 and the tab 322 in the tray 300, according to an embodiment of the present disclosure.
[0016] Fig. 6b depicts a cross-sectional assembled view of the bearing 200 and the tray 300, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0017] 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.
[0018] 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.
[0019] 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.
[0020] 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.
[0021] 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.
[0022] The tray and the bearing of the implant are locked via a secure locking mechanism defined between the two. The secure locking mechanism keeps the tray and the bearing of the implant firmly in place. This also reduces the risk of dislocation of the tray and the bearing, enhancing the implant’s function and longevity and helps to distribute mechanical load evenly thus, minimizing stress concentration between the tray and the bearing. Further, the design of the implant simplifies the surgical process by cutting down surgery time and minimizing errors.
[0023] 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.
[0024] 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 200 at the distal end 140 and a tray 300 at the proximal end 120 of the implant 100. The bearing 200 is coupled to the tray 300, which has been explained later. Details of the bearing 200 have been explained in the context of Figs. 3-4 while details of the tray 300 have been explained in the context of Fig. 5.
[0025] The bearing 200 may be made of any biocompatible poly metal material or metal. The metal that may be used in making the bearing 200 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 200 is made of ultra-high molecular weight polyethylene (UHMWPE). Alternatively, the bearing 200 can be made of any poly material without any metal. The dimensions of the bearing 200 may vary according to or based upon the anatomy of the patient and/or of the patient population in consideration.
[0026] The bearing 200 includes a top surface 210 and a bottom surface 220. The top surface 210 is depicted in Fig. 3. The top surface 210 has two ends, a first end 210a and a second end 210b. The bearing 200 is a tubular structure including a slant. More specifically, in an embodiment, the top surface 210 of the bearing 200 is slanted. That is, the width of the bearing 200 reduces from the first end 210a end to the diametrically opposite second end 210b. In the depicted embodiment, L1 and L2 define the width of two diametrically opposite ends, the first end 210a and the second end 210b. As shown, L2 is less than L1. This slant conforms to the underlying human anatomy where the implant 100 is to be secured.
[0027] The top surface 210 of the bearing 200 may include a curvature. In an embodiment, the top surface 210 includes a concave curvature. In another embodiment, the top surface 210 includes a convex curvature. The curvature of the top surface 210 of the bearing 200 is configured to receive at least a portion of the glenoid component.
[0028] The bottom surface 220 is depicted in Fig. 4. The bottom surface 220 of the bearing 200 is configured to sit over the surface of the tray 300 of the implant 100.
[0029] The bottom surface 220 of the bearing 200 includes a protruding section 221, depicted in Fig. 4. The protruding section 221 may be symmetrically shaped having a peripheral edge. Alternately, the protruding section 221 may be asymmetrically shaped having a peripheral edge. In an embodiment, the protruding section 221 is centrally disposed on the bottom surface 220 of the bearing 200. Alternately, the protruding section 221 may be placed at an offset from the center.
[0030] In an exemplary depiction, the protruding section 221 may be a central disc (hereinafter, a disc 221). In an embodiment, the disc 221 is circular. Alternately, the disc 221 may be circular, ellipse, oval, spherical, etc. The disc 221 extends away from the bottom surface 220 of the bearing 200 defining a specific height. It is to be noted that the height of the disc 221 may be different for various embodiments and is dependent on a patient’s anatomy. The disc 221 is configured to sit over a base 321 of the tray 300 for effective locking of the bearing 200 and the tray 300, as described below.
[0031] At the peripheral edge of the disc 221 of the bearing 200, two or more legs 226 (hereinafter, legs 226) are provided. The legs 226 extends away from the bottom surface 220 of the bearing 200, defining a specific height (‘w’). For various embodiments, the height (‘w’) of the legs 226 may vary and is dependent on a patient’s anatomy. The legs 226 extend radially outwards from the disc 221. Two adjacent legs 226 subtend at least one of an acute, right or obtuse angle with respect to each other. In an embodiment, adjacent legs 226 subtend a right angle with respect to each other. In an exemplary embodiment, there are four legs 226 extending radially from the disc 221. The number of legs 226 can be varied to achieve required coupling of the bearing 200 and the tray 300. The legs 226 are spaced apart from each other. In an exemplary embodiment, the legs 226 are placed equidistantly from each other. Alternately, the space between two consecutive legs 226 may vary and is predefined. While the depicted embodiment illustrates four legs, more than four legs 226 can be provided as per the teachings of the present invention. In such case, two consecutive legs 226 may be arranged angularly with respect to each other.
[0032] As shown in Fig. 4, in an embodiment, legs 226 have a trapezoidal shape. In an embodiment, each of the legs 226 is curved. Further, in the depicted embodiment, each of the legs 226 includes a bed, a closed edge and an open edge. The bed which is in contact with the bottom surface of the disc 221, has a thickness (w1). For a specific embodiment, the thickness (‘w1’) is dependent on a patient’s anatomy. The open edge of each of the legs 226 defines a groove 224. The groove 224 extends from the exposed surface of the bed till the upper surface of the legs 226. In an embodiment, the groove 224 has a T-shaped cross-section, including a head and a tail. Alternately, the groove 224 may have a varied cross-section corresponding to mating component of the tray 300.
[0033] The head of the groove 224 extends at least partially along the width (T1) of the legs 226 while the tail of the groove 224 extends at least partially along the circumferential length (T2) of the legs 226. The groove 224 is configured to mate with a flange 325 of the tray 300 for effective locking of the bearing 200 and the tray 300, as described below. Further, the bed of each of the legs 226 includes a slot 225. The slot 225 may be present at an edge of the groove 224. In an embodiment, the slot 225 has a rectangular cross-section. Alternately, the slot 225 may have a circular, rectangular, spherical, etc. cross-section. The slot 225 is configured to mate with a tab 322 of the tray 300 for effective locking of the bearing 200 and the tray 300, as described below.
[0034] Fig. 5 depict a perspective view of the tray 300. The tray 300 may be made of any biocompatible poly material or metal. The metal that may be used in making the tray 300 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 300 is made of titanium. The dimensions of the tray 300 may vary according to or based upon the anatomy of the patient and/or of the patient population in consideration.
[0035] The tray 300 includes a top side 320 and a bottom side 310. The bottom side 310 of the tray 300 may include an extension 327. The extension 327 is used to fix the implant 100 to the humerus bone of the glenohumeral joint. The extension 327 may be cylindrical, conical, tubular, spherical etc. in shape. The top side 320 of the tray 300 is configured to receive the bottom surface 220 of the bearing 200.
[0036] The top side 320 of the tray 300 as shown in Fig. 5, is circular in shape. Alternately, the shape of the tray 300 may be oval, cylindrical, circular, spherical, ellipse etc. The tray 300 includes a base 321. The base 321 is configured to interface with the disc 221 of the bearing 200 for effective locking of the bearing 200 and the tray 300, as described below. A wall extends from the base 321. The wall surrounds the base 321. On the base 321, two or more vertical slabs 326 are provided. Each of the vertical slabs 326 connects with the inner surface of the wall. The vertical slabs 326 are placed apart from each other. In an embodiment, the vertical slabs 326 are positioned equidistantly from each other. The adjacent vertical slabs 326 may subtend one of an acute, right, or obtuse angle with respect to each other. In an embodiment, the adjacent vertical slabs 326 subtend right angle with respect to each other. It is to be noted that the number of vertical slabs 326 of the tray 300 correspond to the number of legs 226 of the bearing 200. Hence, in case more than four legs 226 are provided in the bearing 200, the number of vertical slabs 326 in the tray 300 will vary accordingly. Further the disposition of the vertical slabs 326 will correspond to the disposition of the legs 226 of the bearing 200.
[0037] The tray 300 includes two or more flanges 325. The flange 325 extends from a side of each of the vertical slabs 326, defining a specific width (‘t’). In an embodiment, the width of the flange 325corresponds to the dimensions of the grooves 224 of the bearing 200. In an exemplary embodiment, the flange 325 is configured to be dimensionally smaller than the corresponding vertical slab 326. In an embodiment, the flange 325 has a T-shaped cross-section. Alternately, the flange 325 may have a varied cross-section corresponding to its mating component in the bearing 200. In the depicted embodiment, the flange 325 is curved. The flanges 325 is configured to mate with the grooves 224 of the bearing 200 for effective locking of the bearing 200 and the tray 300, as described below. A tab 322 is provided with each of the flanges 325. More specifically, the tab 322 extends from a side of the flange 325. In an embodiment, the tab 322 extends from an edge of the top side of the flange 325. In an exemplary embodiment, the tab 322 has a rectangular cross-section. The tab 322 is configured to mate with the slot 225 of the bearing 200 for effective locking of the bearing 200 and the tray 300, as described below.
[0038] The flanges 325, the tabs 322 and the vertical slabs 326 of the tray 300 and the disc 221, the legs 226, the grooves 224 and slots 225 of the bearing 200 may be laser cut, or carved using any optimal machining process in respective components. Alternately, these may be separate components and thereafter welded, etc.
[0039] The implant 100 includes the assembly of the bearing 200 and the tray 300. The bearing 200 is seated over the tray 300. The disc 221 of the bearing 200 interfaces the base 321 of the tray 300. Further, for the assembly the bearing 200 is rotated over the tray 300 in a desired direction of rotation. In an embodiment, the bearing 200 is rotated in the anticlockwise direction.
[0040] Further, with the rotation of the bearing 200 over the tray 300, the flange 325 fits into the groove 224 of the bearing 200. Subsequentially, the tab 322 of the tray 300 fits into the slot 225 of the bearing 200. Fig. 6a depicts a press fit lock 600 of the tab 322 of the tray 300 and the slot 225 of the bearing 200. Thus, locking the bearing 200 and the tray 300 of the implant 100. The cross-section view of the assembly post locking of the bearing 200 and the tray 300 is shown in Fig. 6b. The first locking component, the grooves 224 and the slots 225 of the bearing 200 upon mating with the respective flanges 325 and tabs 322 define a secure locking mechanism of the bearing 200 and the tray 300.
[0041] The implant 100 is replaced by 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 327 of the tray 300 is placed in the reamed portion of the humeral bone. The extension 327 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.
[0042] It is to be noted that the aforesaid description details various slabs/flanges, 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.
[0043] 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 (200) including:
i. a protruding section (221) having a peripheral edge;
ii. two or more legs (226), provided at the peripheral edge of the protruding section (221), each of the legs (226) includes a bed, a slot (225) inside the bed, a closed edge and an open edge, the open edge defining a groove (224);
c. a tray (300) coupled to the bearing (200), including:
i. a base (321);
ii. a wall extending from the base (321);
iii. two or more vertical slabs (326) provided on the base (321);
iv. two or more flanges (325) configured to mate with the groove (224) of the respective legs (226), each flange (325) extending from the respective vertical slab (326); and
v. a tab (322) provided with each of the flange (325), configured to be locked with the slot (225).
2. The implant (100) as claimed in claim 1 wherein the protruding section (221) is one of symmetrically or asymmetrically shaped.
3. The implant (100) as claimed in claim 1 wherein the legs (226) is trapezoidal in shape.
4. The implant (100) as claimed in claim 1 wherein the slot (225) has a rectangular cross-section.
5. The implant (100) as claimed in claim 1 wherein the grooves (224) extend partially across width of the legs (226).
6. The implant (100) as claimed in claim 1 wherein, at least one of, the groove (224) and the flange (325) includes a T-shaped cross-section.
7. The implant (100) as claimed in claim 1 wherein at least one of the adjacent legs (226) and vertical slabs (326) subtend one of an acute, right or obtuse angle with respect to each other.
8. The implant (100) as claimed in claim 1 wherein the tab (322) has a rectangular cross-section.
9. The implant (100) as claimed in claim 1 wherein at least one of the legs (226) and the flanges (325) is curved.
10. The implant (100) as claimed in claim 1 wherein, at least one of the, bearing (200) and the tray (300) are made from one of a biocompatible metal or poly material.
11. The implant (100) as claimed in claim 1 wherein, a top surface (210) of the bearing (200) includes a curvature.
12. The implant (100) as claimed in claim 1 wherein, the bottom surface (310) of the tray (300) includes an extension (327).
13. The implant (100) as claimed in claim 1 wherein, the bearing (200) is a tubular structure including a slant.