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:
SHOULDER 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
[1] The present disclosure relates to a medical implant. More particularly, the present disclosure relates to an orthopedic implant.
BACKGROUND OF INVENTION
[2] Human body consists of numerous ball and socket joints which, allow smooth movement in the bones. For eg: shoulder joint (glenohumeral joint), hip joint. The ball and socket joint allows for a wide range of motion including rotation, lifting, and swinging movements.
[3] Taking an example of a shoulder joint known as a glenohumeral joint, the glenohumeral joint has great mobility but is also relatively unstable compared to other joints, making it more susceptible to dislocations and injuries. There are several medical conditions associated with glenohumeral joints including inflammation, instability due to loosening of the joints, compression of the rotator cuff, etc. causing pain and stiffness. Osteoarthritis and/or rheumatoid arthritis can affect the glenohumeral joint, leading to pain, stiffness, and reduced motion.
[4] Patients suffering from such medical conditions undergo arthroplasty. In this procedure, damaged or diseased parts of the shoulder joint are replaced with artificial parts (prosthesis). In arthroplasty, the ball is placed on a socket side of a joint. The socket is then placed on the arm side, where it is supported by a metal stem in the arm bone (humerus) (as shown in Fig. 1).
[5] However, conventional implants heavily suffer from problems such as loose locking, instability, inefficient load distribution, and wear and tear. The misalignment and/or loosening of the shoulder prosthesis may also lead to improper functioning of the shoulder prosthesis and compromising rotational stability of the shoulder joint, which is essential for optimal performance and patient satisfaction. This can in turn cause uneven mechanical load distribution between joints leading to the rise of several complications and diseases such as osteolysis.
[6] Thus, there arises a need for an implant that overcomes the problems associated with conventional implants.
SUMMARY OF INVENTION
[7] 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.
[8] The present disclosure relates to an implant. In an embodiment, the implant includes a bearing and a tray coupled to the bearing. The bearing includes a plurality of protrusions and a plurality of grooves. The plurality of protrusions extends away from a bottom surface of the bearing. The plurality of grooves are placed at a pre-defined distance from each other and at the peripheral edge of the bearing. The tray includes a base, a wall, and a plurality of projections. The wall surrounds the base and includes a circumferential channel in its inner surface. The plurality of projections protrudes from the rim of the wall in a proximal direction. The plurality of protrusions are aligned and inserted in the channel of the tray. The grooves of the bearing are coupled with the respective projections of the tray.
BRIEF DESCRIPTION OF DRAWINGS
[9] 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 instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[10] Fig. 1 depicts a glenohumeral joint, according to an embodiment of the present disclosure.
[11] Fig. 2 depicts a perspective view of an implant 100, according to an embodiment of the present disclosure.
[12] Fig. 3 depicts a perspective view of a bottom surface 110b of a bearing 110, according to an embodiment of the present disclosure.
[13] Fig. 4 depicts a perspective view of a tray 120, according to an embodiment of the present disclosure.
[14] Fig. 5 depicts a perspective view of the coupling between the bearing 110, and the tray 120, according to an embodiment of the present disclosure.
[15] Fig. 6a depicts a cross-sectional view of the coupling between the bearing 110, and the tray 120, according to an embodiment of a present disclosure.
[16] Fig. 6b depicts an enlarged view of Part A, according to an embodiment of a present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[17] 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.
[18] 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.
[19] 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
[20] 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.
[21] The present disclosure relates to a prosthesis (or implant). The implant is used in various joint replacement surgeries such as reverse shoulder arthroplasty, total hip arthroplasty, etc. In an embodiment, the implant includes a bearing seated on a tray. The bearing and the tray are coupled via a locking mechanism. The locking mechanism between the bearing and the tray provides stability, secure fit, efficient load distribution, ease of implantation, minimized wear and tear, and enhanced durability. The locking mechanism of the present disclosure is vital for the performance, longevity, and success of implants, contributing significantly to patient outcomes and quality of life post-surgery. The locking mechanism ensures that the bearing and the tray are securely locked in place, thereby minimizing the risk of dislocation of the implant components. This stability is crucial for the proper functioning and longevity of the implant. This reduces stress concentrations, which can lead to wear and tear or even failure of the implant over time. The locking mechanism further reduces micromotion between the bearing and the tray thereby, minimizing wear and particle generation. This is important for reducing the risk of osteolysis (bone resorption) caused by wear particles. The locking mechanism enhances the overall durability and lifespan of the implant by maintaining a secure connection between the bearing and the tray, even under repetitive stresses and movements. Thus, the present disclosure contributes to better postoperative comfort and function for the patient.
[22] In an embodiment, the implant replaces the head of the humeral bone of glenohumeral joint . 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.
[23] Now, referring to the Figures, Fig. 2 depicts an implant 100, according to an embodiment of the present disclosure. In an embodiment, the implant 100 replaces the injured or damaged head of the humerus bone of a glenohumeral joint. The implant 100 includes a proximal end 100a and a distal end 100b. The implant 100 includes a bearing 110 and a tray 120. The bearing 110 is coupled to the tray 120 via a locking mechanism, which has been explained later. Details of the bearing 110 are explained in the context of Fig. 3 while the details of the tray 120 are explained in the context of Fig. 4.
[24] The bearing 110 (as shown in Fig. 2) is disposed at the proximal end 100a of the implant 100. The bearing 110 may be made of any biocompatible poly material or metal. The metal that may be used in making the bearing 110 may include, without limitation, titanium, cobalt-chromium (CoCr), stainless steel, 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. In an exemplary embodiment, the bearing 110 is made of ultra-high molecular weight polyethylene (UHMWPE). The dimensions of the bearing 110 may vary according to or based upon the anatomy of the patient and/or of the patient population in consideration. The bearing 110 is coupled with the tray 120 via the locking mechanism as described later, thereby leading to secure attachment of the bearing 110 with the tray 120 and ensuring patient’s safety.
[25] The bearing 110 (as shown in Fig. 3) is a tubular structure that includes a body having a top surface 110a and a bottom surface 110b. Towards the bottom surface 110b, a disc 111, a collar 113, a plurality of protrusions 115, a first mating surface 117, and a plurality of grooves 119 are included. The top surface 110a of the bearing 110 is slanted. That is, the width of the bearing 110 reduces from one end to a diametrically opposite end. In the depicted embodiment, L1 and L2 define the width of the two diametrically opposite ends. As shown in Fig. 3, L2 is less than L1. This slant conforms to the underlying human anatomy on which the implant 100 is to be secured.
[26] The top surface 110a of the bearing 110 may include a curvature. In an embodiment, the top surface 110a includes a concave structure. In another embodiment, the top surface 110a includes a convex curvature. The curvature of the top surface 110a of the bearing 110 is configured to receive at least a portion of the glenoid component.
[27] The bottom surface 110b is depicted in Fig. 3. The bottom surface 110b of the bearing 110 is configured to sit over the top surface of the tray 120 of the implant 100.
[28] The bottom surface 110b of the bearing 110 as shown in Fig. 3 includes the disc 111. The disc 111 may be circular, oval, sphere, ellipse, etc. in shape. The disc 111 extends away from the bottom surface 110b of the bearing 110 defining a specific height. In an embodiment, the height of the disc 111 varies according to the patient anatomy. The disc 111 is configured to sit in the base 121 of the tray 120 as described later. The disc 111 is anti-rotational in nature, thereby providing stability to the coupling of the with the tray 120.
[29] The disc 111 is surrounded by a collar 113 at a predefined distance. The collar 113 is thus disposed circumferentially. The collar 113 is provided on the bottom surface 110b of the bearing 110. The collar 113 may be a solid or hollow band. The predefined distance between the collar 113 and the disc 111 provides clearance space 113a therebetween.
[30] The plurality of protrusions 115 are provided on the collar 113. Specifically, on top of the collar 113, a plurality of protrusions 115 are provided (Fig. 3). The plurality of protrusions 115 extends away from the bottom surface 110b of the bearing 110. The plurality of protrusions 115 are placed at pre-defined interval/(s) 115a from each other. In an embodiment, the protrusions 115 are equidistant from each other. Alternately, the interval 115a between two adjacent protrusions 115 may vary. In an exemplary embodiment, the protrusions 115 are L-shaped pegs. Each L-shaped peg includes an axial component coupled to a radial component, together forming the L-shape. The axial component extends parallel to the longitudinal axis of the implant 100 while the radial component extends in a radial direction away from the center of the bottom surface 110b of the bearing 110. The axial component may be rectangular, triangular, square etc. in shape. Other shapes/structures of the protrusions 115 that can be used in conjunction with the teachings of the invention are within the scope of the teachings of the present disclosure.
[31] In an embodiment, the collar 113 may be absent and the protrusions 115 may protrude from the bottom surface 110b of the bearing 110 directly.
[32] The body of the bearing 110 includes a first mating surface 117 provided adjacent to the collar 113 or protrusions 115 as the case may be. The first mating surface 117 of the bearing 110 is configured to mate with the rim 123c of the tray 120 for effective locking of the tray 120 and the bearing 110, as described below.
[33] The body of the bearing 110 further includes a plurality of grooves 119. The grooves 119 of the bearing 110 are configured to mate with the respective projections 127 of the tray 120 for effective locking of the tray 120 and the bearing 110, as described below.
[34] The grooves 119 are disposed at the peripheral edge of the bearing 110. The grooves 119 are placed at a pre-defined distance from each other. In the depicted embodiment, the grooves 119 are equidistant from each other. Alternate dispositions of the grooves 119 are within the teachings of the present disclosure. In an exemplary embodiment, the bearing 110 consists of four grooves 119. In another embodiment, the bearing 110 may be provided with more than four grooves 119. In an exemplary embodiment, the grooves 119 are nearly rectangular cutouts in the body of the bearing 110. Other shapes/structures of the grooves 119 that can be used in conjunction with the teachings of the invention are within the scope of the teachings of the present disclosure.
[35] The tray 120 (as shown in Fig. 4) is disposed at the distal end 100b of the implant 100. The tray 120 may be made of any biocompatible poly material or metal. The metal that may be used in making the tray 120 may include, without limitation, titanium, cobalt chromium, and stainless steel (SS316). 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. In an exemplary embodiment, the tray 120 is made of titanium. The dimensions of the tray 120 may vary according to or based upon the anatomy of the patient and/or of the patient population in consideration. The tray 120 replaces the diseased portion of the humeral head of the patient.
[36] The tray 120 includes a proximal end 120a and a distal end 120b. The tray 120 includes a base 121, a wall 123, a channel 125, a plurality of projections 127, and an extension 129. The base 121 is disposed at the proximal end 120a. The base 121 of the tray 120 is configured to seat the disc 111 of the bearing 110 for effective locking of the tray 120 and the bearing 110 of the implant 110. As depicted the base 121 is substantially circular in shape, however other shapes as permissible for use in the context of the relevant human anatomy can be used.
[37] From the base 121, the wall 123 extends away from the proximal end 120a. The wall 123 surrounds the base 121. The base 121 and the wall 123 form a cup shaped structure. In an embodiment, the wall 123 is of uniform thickness. Alternately, the wall 123 may be of a stepped configuration. That is, the first portion 123a of the wall 123 adjacent to the base 121 is broader compared to the second portion 123b of the wall 123 distant from the base 121.
[38] The wall 123 defines a rim 123c that is configured to mate with the first mating surface 117 of the bearing 110 when the tray 120 and the bearing 110 are coupled to form the implant 100. The rim 123c is disposed towards the proximal end 120a.
[39] The wall 123 includes a circumferential channel 125 extending at least partially around the inner surface of the wall 123. In an embodiment, the channel 125 is provided throughout the circumference of the inner surface of the wall 123. Alternately, the channel 125 may be provided till 3/4th of the circumference of the wall 123 on the inner surface. The channel 125 is configured to seat the radial component of the plurality of protrusions 115 of the bearing 110. It is to be noted that in case the channel 125 extends partially in the wall 123, the bearing 110 is provided with the plurality of protrusions 115 only in the corresponding portion of the bottom surface 110b.
[40] In depicted embodiment, the channel 125 is carved at the center in the inner surface of the wall 123. Alternately, the disposition of the channel 125 may vary depending upon the height of the axial component of the protrusions 115.
[41] The plurality of projections 127 protrude from the rim 123c in the proximal direction. In an exemplary embodiment, the tray 120 includes four projections 127. In another embodiment, the tray 120 may be provided with more than four projections 127. The number of projections 127 is complementary to the number of grooves 119. In the depicted embodiment, the projections 127 are equidistant from each other. Alternately, the distance between the projections 127 can vary corresponding to the distance between the grooves 119 of the bearing 110. In an exemplary embodiment, the shape of the projections 127 is rectangular with curved edges. Alternately, the projections 127 can be made of other shapes corresponding to the shapes of the grooves 119 of the tray 120. The projections 127 of the tray 120 are configured to be seated in the corresponding grooves 119 of the bearing 110, thereby providing a rigid and immovable coupling of the tray 120 and the bearing 110.
[42] The extension 129 is situated towards the distal end 120b. The extension 129 is disposed at the center of the distal end 120b. Alternate dispositions of the extension 129 are within the scope of the present disclosure. The extension 129 has a pre-defined shape, including, but not limited to, tubular, cylindrical, cone-shaped, barrel shaped, can shaped. In an exemplary embodiment, the extension 129 is tubular in shape. The poly material includes without limitation, ultra-high molecular weight polyethylene (UHMWPE), polymethyl methacrylate (PMMA), highly cross-linked polyethylene (HXLPE) including Vitamin E. In an exemplary embodiment, the extension 129 is made of titanium. The dimensions of the extension 129 may vary according to or based upon the anatomy of the patient and/or of the patient population in consideration. The socket is inserted into the extension 129 which extends along the longitudinal axis through the humerus of the patient (not shown).
[43] The disc 111, the protrusions 115 and the grooves 119 of the bearing 110 along with the channel 125 and the projections 127 of the tray 120 define the locking mechanism of the implant 100. For assembly of the implant, the bearing 110 is seated over the tray 120. Specifically, the plurality of protrusions 115 are aligned and inserted in the channel 125 of the tray 120 (also shown in Fig.5). In an embodiment, due to compressible nature of the protrusions 115, once the protrusions 115 are aligned and inserted in the channel 125, they form a tight snap fit coupling. Next, the grooves 119 of the bearing 110 are coupled with the respective projections 127 of the tray 120. And finally, the disc 111 of the bearing 110 is seated in the base 121 of the tray 120. It is evident form the above that the implant 100 formed by the assembly of the tray 120 and bearing 110 includes two rigid locking mechanisms due to the chances of any movement or dislocation of the two components is eliminated. The first locking mechanism is defined by the plurality of protrusions 115 and the channel 125. The second locking mechanism is defined by grooves 119 of the bearing 110 and the respective projections 127 of the tray 120. The assembled implant 100 may then be implanted at the prepared site (as shown in Fig. 6 and Fig. 6b).
[44] It is to be noted that the aforesaid description details various protrusions 115/projections 127, /grooves 119 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.
[45] The protrusions 115 and the grooves 119 of the bearing 110 and the rim 123c and the projections 127 of the tray 120 may be laser cut, or carved using any optimal machining process in the respective components. Though, in another embodiment, the protrusions 115 and the grooves 119 of the bearing 110 and the rim 123c and the projections 127 of the tray 120 may be separable and thereafter welded, etc.
[46] 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. , C , Claims:WE CLAIM:
1. An implant (100) comprising:
A. a bearing (110) including:
i. a plurality of protrusions (115) that extends away from a bottom surface (110b) of the bearing (110); and
ii. a plurality of grooves (119) placed at a pre-defined distance from each other and at the peripheral edge of the bearing (110);
B. a tray (120) operatively coupled to the bearing (110), the tray (120) including:
i. a base (121);
ii. a wall (123) surrounding the base (121), the wall (123) including a circumferential channel (125) in its inner surface; and
iii. a plurality of projections (127) protruding from the rim (123c) of the wall (123) in a proximal direction;
wherein the plurality of protrusions (115) are aligned and inserted in the channel (125) of the tray (120);
wherein the grooves (119) of the bearing (110) are coupled with the respective projections (127) of the tray (120).
2. The implant (100) as claimed in claim 1 wherein, at least one of the bearing (110) and the tray (120) are made from one of a metal or biocompatible poly material.
3. The implant (100) as claimed in claim 1 wherein, the bearing (110) is a tubular structure including a slant.
4. The implant (100) as claimed in claim 1 wherein, the bearing (110) includes a disc (111) that extends away from the bottom surface (110b) of the bearing (110).
5. The implant (100) as claimed in claim 1 wherein, the plurality of protrusions (115) are placed at a pre-defined intervals (115a) from each other.
6. The implant (100) as claimed in claim 1 wherein, the plurality of protrusions (115) are L-shaped pegs, each L-shaped peg includes:
A. an axial component that extends parallel to a longitudinal axis of the implant (100); and
B. a radial component that extends in a radial direction away from center of the bottom surface (110b) of the bearing (110).
7. The implant (100) as claimed in claim 1 wherein, the plurality of protrusions (115) are provided on a collar (113) provided on the bottom surface (110b) of the bearing (110).
8. The implant (100) as claimed in claim 1 wherein, at least one of the grooves (119) and the projections (127) are equidistant from each other.
9. The implant (100) as claimed in claim 1 wherein, the grooves (119) are nearly rectangular cutouts in the body of the bearing (110).
10. The implant (100) as claimed in claim 1 wherein, the wall (123) is of uniform thickness or of a stepped configuration.
11. The implant (100) as claimed in claim 1 wherein, the channel (125) is provided throughout the circumference of the inner surface of the wall (123).
12. The implant (100) as claimed in claim 1 wherein, the shape of the projections (127) is rectangular with curved edges.
13. The implant (100) as claimed in claim 1 wherein, the implant (100) includes an extension (129) towards a distal end 120b.
14. The implant (100) as claimed in claim 1 wherein, the protrusions (115), the grooves (119) and the projections (127) are laser cut.