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 a 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 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 orthopedic implant comprising a proximal end and a distal end, a bearing and a tray. The bearing includes a bottom surface. The bottom surface of the bearing includes a first locking component and two or more second locking components. The first locking component includes a cavity extending at least partially along the length of the first locking component. The two or more second locking components disposed on either side of the first locking component, each second locking component defining a first cross-section.
[007] The tray is operatively coupled to the bearing. The tray includes, a base, a wall surrounding the base and a hole. Further, the tray includes two or more flanges. Each flange includes a groove having a cross-section complementary to the second locking component and a peg for coupling the bearing and the tray via the cavity.
[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 perspective view of 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] Figs. 3a-3c depict respective perspective views of a bearing 300 of the orthopedic implant 100, according to an embodiment of the present disclosure.
[0013] Figs. 4a-4b depict respective perspective views of a tray 400 of the orthopedic implant 100, according to an embodiment of the present disclosure.
[0014] Fig. 5 depicts a perspective view of a peg 500 of the orthopedic implant 100, according to an embodiment of the present disclosure.
[0015] Figs. 6a-6b depict a cross-section of an assembled view of the bearing 300 and the tray 400 of the orthopedic implant 100, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0016] 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.
[0017] 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.
[0018] 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.
[0019] 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.
[0020] 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. The implant includes a tray and a bearing.
[0021] 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.
[0022] Though the locking mechanism of the present disclosure is explained with respect to a shoulder implant, it can be extended to different parts of a human body, such as a hip implant, which are within the scope of the teachings of the present disclosure.
[0023] 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 125. The implant 100 includes a bearing 300, a tray 400 and a peg 500. The bearing 300 is provided at the distal end 125 while the tray 400 is provided at the proximal end 120 of the implant 100. The tray 400 is operatively coupled to the bearing 300, which has been explained later. Details of the bearing 300 have been explained in the context of Figs. 3a-3c while details of the tray 400 have been explained in the context of Figs. 4a-4b.
[0024] 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.
[0025] 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 is a tubular structure including a slant. 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, L1 is less than L2. This slant conforms to the underlying human anatomy where the implant 100 is to be secured.
[0026] 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.
[0027] The bottom surface 310 is depicted in Figs. 3b-3c. The bottom surface 310 of the bearing 300 is configured to sit over the base of the tray 400 of the implant 100.
[0028] The bottom surface 310 of the bearing 300 includes a first locking component 315, depicted in Figs. 3b-3c. In an embodiment, the first locking component 315 is centrally disposed on the bottom surface 310 of the bearing 300. Alternately, the first locking component 315 may be placed at an offset from the center on the bottom surface 310 of the bearing 300. The first locking component 315 is configured to sit over the base 415 of the tray 400 for effective locking of the bearing 300 and the tray 400, as explained below.
[0029] In an exemplary depiction, the first locking component 315 may be a projection extending away from the bottom surface 310 (hereinafter, the projection 315). The projection 315 may have a predefined height (‘h’) and width (‘w’) (Fig. 3b). It is to be noted that, in various embodiments the height (‘h’) and width (‘w’) of the projection 315 may vary, and is dependent on a patient’s anatomy. According to an embodiment, the length of the projection 315 corresponds to the diameter of the bottom surface 310 of the bearing 300.
[0030] In the depicted embodiment, the projection 315 has a cuboidal structure. The projection 315 has a nearly rectangular cross-section. Alternately, the projection 315 may be tubular, conical, cuboidal, rectangular, spherical etc. The projection 315 may be tapered or beveled at one or more edges.
[0031] The projection 315 includes two ends namely, a first end 315a and a second end 315b. The first end 315a of the projection 315 includes a cavity 320. In an embodiment, the cavity 320 is circular having a predefined diameter. It is to be noted that, in various embodiments, the diameter of the cavity 320 is dependent on the dimensions of the projection 315. Alternately, the cavity may be oval, spherical, circular. The cavity 320 extends at least partially along the length of the projection 315. The cavity 320 is provided with threads. The threads of the cavity 320 may run along, throughout the or partial length of the projection 315. The cavity 320 is configured to receive the peg 500 through a hole 420 of the tray 400 for secure locking of the bearing 300 and the tray 400, as described below.
[0032] The bottom surface 310 includes two or more second locking components disposed on either side of the projection 315. The second locking components extend away from the bottom surface 310 defining a specific height (‘x’) (Fig. 3c). In various embodiments, the height (‘x’) of the second locking components 325,330 may vary according to a patient’s anatomy. In an embodiment, there are two second locking components 325 and 330 as depicted in Figs. 3b-3c. In the depicted embodiment, the second locking components 325 and 330 are placed at diametrically opposite ends of the bottom surface 310. Alternately, four second locking components may be provided, one in every quarter of the bottom surface 310. It is to be noted that the number of second locking components may vary depending upon the locking requirements.
[0033] The second locking components 325,330 define a first cross-section. In an embodiment, the first cross-section is a T- shaped cross-section. In an embodiment, the second locking components 325,330 is curved in the shape of arc. Each of the second locking components 325,330 includes a vertical portion 325a,330a and a horizontal portion 325b,330b. The vertical portion 325a,330a extends away from the bottom surface 310 defining a specific height (‘x1’). Further, the horizontal portion 325b,330b is placed on top of the respective vertical portion 325a,330a. In the depicted embodiment, the vertical portion 325a,330a and the respective horizontal portion 325b,330b are substantially perpendicular to each other. Alternately, the vertical portion 325a,330a and the respective second horizontal portion 325b,330b may define a specific angle. In an embodiment, the horizontal portion 325b,330b extends such that, a hollow space exists between the bottom surface of the horizontal portion 325b,330b and the bottom surface 310 of the bearing 300. Such a configuration of the horizontal portion 325b,330b may be provided on either side of the respective vertical portion 325a,330a. The second locking components 325,330 are configured to fit into the grooves 430,440 of the tray 400 for effective locking of the bearing 300 and the tray 400, as described below. Due to this mating of the locking mechanism hence created, the bearing 300 and the tray 400 exhibit anti-rotational property.
[0034] 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.
[0035] 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 120, may include an extension 445. The extension 445 is used to fix the implant 100 to the humerus bone of the glenohumeral joint. The extension 445 may be cylindrical, circular, spherical, conical etc. in shape.
[0036] The top surface 410 of the tray 400 is configured to receive the bearing 300. The top surface 410 of the tray 400 is shown in Figs. 4a-4b. The top surface 410 of the tray 400 includes a central base 415 (hereinafter, a base) surrounded by a wall 450 extending from the edge of the base 415 (Fig. 4b). In an embodiment, the base 415 is circular. The wall 450 includes a rim. The base 415 is configured to interface with the first locking component 315 of the bearing 300 for effective locking of the bearing 300 and the tray 400, as described below.
[0037] The top surface 410 of the tray 400 includes two or more flanges. According to an embodiment, there are two flanges namely, a first flange 425 and a second flange 435. The flanges 425,435 extend away from the base 415, defining a specific height (‘y’). It is to be noted that the height (‘y’) of the flanges 425, 435 corresponds to the height (‘x’) of the second locking components 325, 330 of the bearing 300. Further, the flanges adjoin the wall 450. For various embodiments, the flanges 425,435 may have a predefined width (‘z’). In an embodiment, the shape of the flanges 425,435 is substantially trapezoidal. According to an embodiment, the first flange 425 and the second flange 435 are positioned diametrically opposite to each other. It is to be noted that the number of flanges of the tray 400 correspond to the number of second locking components 325, 330 of the bearing 300. Hence, in case more than two second locking components 325,330 are provided in the bearing 300, the number of flanges in the tray 400 will vary accordingly.
[0038] The flanges 425,435 may be configured with a cut-out groove (hereinafter, a groove). In an embodiment, the first flange 425 includes a groove 430 and the second flange 435 includes a groove 440. The grooves 430,440 have a cross-section complementary to the second locking component 325,330. In an embodiment, the grooves 430,440 has a T-shaped cross-section having a head and a tail. The head of the grooves 430,440 may be positioned at a height (y1) from the base 415. It is to be noted that, for various embodiments, the height (‘y1’) at which the head of the grooves 430,440 are present may vary. Further, the height (‘y1’) at which the head of the grooves 430,440 are present, corresponds to the height (‘x’) of the second locking components 325,330 of the tray 400.The grooves 430,440 are configured to interface with the second locking components 325,330 respectively for an effective locking of the bearing 300 and the tray 400, as described below. Specifically, the horizontal portions 325b,330b of the second locking component mates with the tail of the groove while the vertical portions 325a,330a of the second locking component mates with the head of the groove.
[0039] According to an embodiment, the wall 450 of the tray 400 includes a hole 420 of a specific diameter. Further, the diameter of the hole 420 corresponds to the diameter of the cavity 320 of the bearing 300. The hole 420 provides a passage for the peg 500 such that, the peg 500 may mate with the cavity 320 of the bearing 300 for an effective locking of the bearing 300 and the tray 400, as described below.
[0040] The peg 500 may be any one of a screw, a nail etc. In an embodiment, the peg 500 is a screw. The head of the peg 500 is configured to receive a rotational input from a suitable tool, to rotate the peg 500. In one embodiment, the head of the peg 500 includes a drive socket, configured to engage and be rotated by a key. In an embodiment the head includes a hex drive socket to be engaged and rotated by a hex key. In various other embodiments, the head may include another suitable drive, including, without limitation, a Phillips drive, a tri-wing drive, a square socket drive, a pentagon drive, a Penta lobe drive, a Torx drive, or a double square drive, configured to engage and be rotated by a corresponding driver key. The peg 500 is configured to couple the bearing 300 and the tray 400, via the cavity 320 and the hole 420.
[0041] The flanges 425,435, the hole 420 and the grooves 430,440 of the tray 400 along with the first locking component, and the second locking components of the bearing 300 may be laser cut. Though, in another embodiment the flanges of the tray may be separate pieces, integrated with the tray via welding, wire cut, plasma cut, brazing, EDM etc. Similarly, the first locking component and the second locking components of the bearing 300 may be separate pieces, integrated with the bearing via welding, wire cut, plasma cut, brazing, EDM, etc.
[0042] The implant 100 is formed by the assembly of the bearing 300 and the tray 400. The bearing 300 of the implant 100 is aligned with the tray 400 such that the second locking component 325 of the bearing 300 is inserted in the groove 430 of the tray 400. In parallel, the second locking component 330 of the bearing 300 is inserted in the groove 440 of the tray 400. It is to be noted that for effective mating, the bearing 300 may be rotated in the desired direction. In an embodiment, the bearing 300 is rotated in the clockwise direction marginally. The second locking components 325,330 are inserted in the respective grooves 430,440 till they are completed seated in the grooves 430,440, as shown in Fig. 6a.
[0043] Post this mating, the first locking component 315 is placed over the base 415 of the tray 400. Further, the cavity 320 of the first locking component 315 aligns with the hole 420 of the tray 400. For locking the assembly, the peg 500 (Fig. 5) is inserted into the cavity 320 through the hole 420 of the tray 400 and rotated till completely locked. The mating of the cavity 320 and the hole 420 with the peg 500, creates a secure locking between the bearing 300 and the tray 400, resulting in an even load distribution for the implant 100. At least one of the, hole 420 and the cavity 320 may be one of threaded, non-threaded or semi-threaded. Further, at least one of the, hole 420 and the cavity 320 may include an oval, sphere, or ellipse shape. It is to be noted that, the shape of the hole 420 corresponds to the shape of the cavity 320. The cross-section view of the assembly post locking of the bearing 300 with the tray 400 of the implant 100 is shown in Fig. 6b. The first and second locking components upon mating with respective hole and grooves define a secure locking mechanism between the bearing 300 and the tray 400.
[0044] 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 445 of the tray 400 is placed in the reamed portion of the humeral bone. The extension 445 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.
[0045] It is to be noted that the aforesaid description details various second locking components/flanges /first locking components, 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 (125).
b) a bearing (300) including a bottom surface (310) having
i. a first locking component (315) including a cavity (320) extending at least partially along the length of the first locking component (315);
ii. two or more second locking components (325,330) disposed on either side of the first locking component (315), each second locking component (325,330) defining a first cross-section;
c) a tray (400) operatively coupled to the bearing (300), the tray (400) including:
i. a base (415);
ii. a wall (450) surrounding the base (415) and including a hole (420); and
iii. two or more flanges, each flange including a groove having a cross-section complementary to the second locking component (325,330); and
d) a peg (500) for coupling the bearing (300) and the tray (400) via the cavity (320).
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 as claimed in claim 1 wherein, the top surface (305) of the bearing (300) includes a curvature.
4. The implant as claimed in claim 1 wherein, the bottom surface (405) of the tray (400) includes an extension (445). The implant (100) as claimed in claim 1 wherein, the bearing (300) is a tubular structure including a slant.
5. The implant (100) as claimed in claim 1 wherein, the first locking component (315) is centrally disposed on the bottom surface (310) of the bearing (300).
6. The implant (100) as claimed in claim 1 wherein, the first locking component (315) is disposed at an offset from the center on the bottom surface (310) of the bearing (300).
7. The implant (100) as claimed in claim 1 wherein, the first locking component (315) is one of a cuboidal, tubular, rectangular, spherical or conical projection.
8. The implant (100) as claimed in claim 1 wherein, at least one of the, hole (420) and the cavity (320) is one of threaded, non-threaded or semi-threaded.
9. The implant (100) as claimed in claim 1 wherein, at least one of the, hole (420) and the cavity (320) includes one of an oval, sphere, or ellipse shape.
10. The implant (100) as claimed in claim 1 wherein, the second locking components (325,330) includes a vertical portion (325a,330a) and horizontal portion (325b,330b).
11. The implant (100) as claimed in claim 1 wherein, the second locking component (325,330) is curved in the shape of an arc.
12. The implant (100) as claimed in claim 1 wherein, the first cross-section is a T cross-section.