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 Healthcare Pvt. Ltd., an Indian company of the Survey No. 135/139, Bilakhia House, Muktanand Marg, Chala, Vapi- 396191, Gujarat, India.

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

FIELD OF INVENTION
[1] The present disclosure relates to an implant. More particularly, the present disclosure relates to a shoulder implant.
BACKGROUND OF INVENTION
[2] Shoulder implants are often used in orthopedic surgery to treat conditions that cause pain, limited mobility, and decreased quality of life. Some common reasons may include severe arthritis, fractures, and other degenerative diseases that affect the shoulder joint. These implants can replace damaged or diseased portion of the shoulder joint, such as the humeral head (upper arm bone) or the glenoid (socket of the shoulder blade).
[3] Conventionally available shoulder implants include a stemmed shoulder component that extends into the humeral canal (the central cavity of the upper arm bone), providing stability and fixation.
[4] Due to the stemmed shoulder component, the conventional shoulder implants require removal of a portion of the humeral bone to accommodate the stem of the implant. The said bone removal can weaken the bone and might limit future treatment options in case a revision surgery is required.
[5] Hence, there is a need of a shoulder implant that overcomes the problems associated with the conventional implants.
SUMMARY OF INVENTION
[6] 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.
[7] The present disclosure relates to an implant including a body and a plurality of elongate members. The body including at least a first portion and a third portion. The first portion have a superior outer surface with a convex profile. The third portion is disposed inferior to the first portion. The third portion have an inferior outer surface with a predefined pattern formed thereon. The plurality of elongate members extend inferiorly from the body. The plurality of elongate members are circumferentially spaced around the body.
BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS
[8] 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.
[9] Fig. 1 depicts an implant 100 according to one or more embodiments of the present disclosure.
[10] Fig. 1a depicts an underside of the implant 100 according to one or more embodiments of the present disclosure.
[11] Fig. 1b depicts the implant 100 according to one or more embodiments of the present disclosure.
[12] Fig. 2 depicts a method 200 according to one or more embodiments of the present disclosure.
[13] Fig. 2a depicts a bone 10 configured to receive the implant 100 according to one or more embodiments of the present disclosure.
[14] Fig. 2b depicts the implant 100 implanted over the bone 10 according to one or more embodiments of the present disclosure.
[15] Fig. 3 depicts an implant 300 according to one or more embodiments of the present disclosure.
[16] Fig. 3a depicts a fastener 333 according to one or more embodiments of the present disclosure.
[17] Fig. 3b depicts the fastener 333 coupled to the implant 300 according to one or more embodiments of the present disclosure.
[18] Fig. 4 depicts a method 400 according to one or more embodiments of the present disclosure.
[19] Fig. 4a depicts a bone 30 configured to receive the implant 300 according to one or more embodiments of the present disclosure.
[20] Fig. 4b depicts the implant 300 implanted over the bone 30 according to one or more embodiments of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[21] 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.
[22] 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.
[23] 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.
[24] 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.
[25] This present disclosure discloses a shoulder implant (or implant). The implant may be used for orthopedic surgery in shoulder arthroplasty, i.e., a surgical procedure to restore a damaged or arthritic shoulder joint.
[26] The implant of the present disclosure requires less soft tissue dissection and disruption during surgery. This leads to faster recovery times and reduced postoperative pain. Further, the implant helps to preserve the integrity of the natural bone after implantation and provides an option for a future revision surgery if required.
[27] By preserving the natural bone, the risk of stress shielding is reduced, i.e., the implant takes on the load-bearing function of the bone leading to bone resorption. The implant lowers the risk of periprosthetic fractures because of lack of long stems that may create stress risers in the bone that are prone to fractures.
[28] The implant mitigates chances of slippage of the implant and provides more stability by closely matching the natural anatomy of the shoulder joint. This further improves the longevity and performance of the implant. The implant provides better range of motion for patients, as they don’t disturb the humeral canal and the surrounding soft tissues. This leads to improved postoperative function and mobility.
[29] Now referring to the figures, Fig.1 illustrates an exemplary embodiment of an implant 100. The implant 100 may include, without limitation, a body 110 and a plurality of elongate members 130. The body 110 and the plurality of elongate members 130 may form an integral structure or may be removably coupled to each other. In an exemplary embodiment, the implant 100 is an integral structure. The implant 100 may have a size according to the anatomical dimensions of an implantation site. In an exemplary embodiment, the size of the implant 100 depends upon the anatomical dimensions of a humerus bone (not shown) and/or a glenoid cavity (not shown).
[30] The body 110 may be made of a material including, but not limited to, titanium, cobalt chromium, stainless steel 316 (SS316), etc. In an exemplary embodiment, the body 110 is made of titanium. The body 110 may either be a hollow structure or a solid structure. In an exemplary embodiment, the body 110 is a solid structure.
[31] The body 110 may include a plurality of portions. In an exemplary embodiment, as shown in Figs. 1 and 1a, the body 110 include a first portion 111, a second portion 113 and a third portion 115.
[32] The first portion 111 of the body 110 may have a pre-defined shape corresponding to the glenoid cavity or equivalent structure. In an exemplary embodiment, the first portion 111 is hemi-spherically shaped. A superior outer surface of first portion 111, disposed superiorly, interacts with the glenoid cavity after implantation. The superior outer surface may have a convex profile corresponding to a concave profile of the glenoid cavity. The superior outer surface of the first portion 111 may be polished and smooth.
[33] In an exemplary embodiment, the first portion 111 may have an outer diameter that is different than the diameter of the glenoid cavity which helps in reducing stress in the glenoid cavity.
[34] The second portion 113 may be optionally provided in the body 110. The second portion 113 may be disposed inferior to the first portion 111. The second portion 113 may have a pre-defined shape including but not limited to cylindrical, oval, round, etc. In an exemplary embodiment, the second portion 113 is cylindrically shaped.
[35] The second portion 113 may have a diameter either equal to the outer diameter of the first portion 111 or different that than the outer diameter of the first portion 111. In exemplary embodiment, as shown in Fig. 1, the diameter of the second portion 113 is same as the outer diameter of the first portion 111. The second portion 113 may have a thickness that may vary according to the bone anatomy.
[36] The third portion 115 may be disposed inferior to the first portion 111 and/or the second portion 113. The third portion 115 may have a pre-defined diameter either equal to, greater than or less than the outer diameter of the first portion 111 and/or the diameter of the second portion 113.
[37] The third portion 115 may define an inferior outer surface as shown in Fig. 1a. The inferior outer surface of the third portion 115 interacts with the underlying bone after implantation, for example a superior surface of the humerus bone. The inferior outer surface of the third portion 115 forms an inferior outer surface of the implant 100.
[38] The inferior outer surface of the third portion 115 may have a pre-defined pattern formed thereon. In an exemplary embodiment, as shown in Fig. 1a, the inferior outer surface of the third portion 115 have a trabecular lattice pattern. The pre-defined pattern on the inferior outer surface of the third portion 115 helps in bone in-growth and osteointegration of the implant 100 with the underlying bone after implantation.
[39] The plurality of elongate members 130 (hereinafter, the elongate members 130) may extend away from the inferior outer surface of the third portion 115. The elongate members 130 may be arranged circumferentially on the third potion 115 (as shown in Fig. 1b). In an exemplary embodiment, as shown in Figs. 1 and 1b, the implant 100 is provided with three elongate members 130.
[40] The elongate members 130 are made of a material including, but not limited to, titanium, cobalt chromium, SS316, etc. In an exemplary embodiment, the elongate members 130 are made of titanium.
[41] The elongate members 130 may have a pre-defined shape including but not limited to straight shaped, J-shaped, conical, etc. In an exemplary embodiment, as shown in Fig. 1, the elongate members 130 are J-shaped. The elongate members 130 prevent rotational motion of the body 110 (and the implant 100) with respect to the underlying bone and enable strong fixation of the implant 100 with the underlying bone after implantation.
[42] Fig. 2 depicts an exemplary method 200 to implant the implant 100 to a bone 10. The method 200 commences at step 201 by preparing the bone 10 to receive the implant 100. The bone 10 may optionally be resected to accommodate the implant 100. In an exemplary embodiment, a head of the humerus bone is resected corresponding to the profile/dimensions of the implant 100.
[43] The bone 10 is prepared by making a plurality of slots 11 in the bone 10 as shown in Fig. 2a. In an exemplary embodiment, the number of slots 11 made in the bone 10 corresponds to the number of elongate members 130 of the implant 100, i.e., for the implant 100 having three elongate members 130, three slots 11 are made in the bone 10. And, the slots 11 have a shape corresponding to the shape of the elongate members 130 thus, providing strong fixation of the implant 100 after implantation. The slots 11 helps in preventing any rotational motion (and/or dislocation) of the implant 100 with respect to the bone 10 after implantation.
[44] In an exemplary embodiment, the slots 11 are made with a punch tool by a physician.
[45] At step 203, the implant 100 is secured over the bone 10. The implant 100 is secured by inserting the plurality of elongate members 130 of the implant 100 in the corresponding slots 11 of the bone 10 as shown in Fig. 2b.
[46] After the elongate members 130 of the implant 100 are inserted into the respective slots 11 of the bone 10, the inferior outer surface of the body 110 interacts with a superior surface 13 (as shown in Fig. 2a) of the bone 10. In other words, the inferior outer surface of the implant 100 perfectly sits over the superior surface 13 of the bone 10.
[47] Fig. 3 depicts an embodiment of an implant 300. The implant 300 includes without limitation a body 310 and a plurality of elongate members 330. The body 310 and the plurality of elongate members 330 may form an integral structure or may be removably coupled to each other. In an exemplary embodiment, the implant 300 is an integral structure. The implant 300 may have a size according to the anatomical dimensions of an implantation site. In an exemplary embodiment, the size of the implant 300 depends upon the anatomical dimensions of the humerus bone (not shown) and/or the glenoid cavity (not shown).
[48] The body 310 of the implant 300 is similar to the body 110. In an exemplary embodiment, as shown in Figs. 3 and 3b, the body 310 includes a first portion 311 and a third portion 315. The first portion 311 of the implant 300 is structurally and functionally similar to the first portion 111 of the implant 100. A superior outer surface of first portion 311, disposed superiorly, interacts with the glenoid cavity after implantation. The superior outer surface may have a convex profile corresponding to a concave profile of the glenoid cavity. The superior outer surface of the first portion 311 may be polished and smooth.
[49] The third portion 315 of the implant 300 is structurally and functionally similar to the third portion 115 of the implant 100. An inferior outer surface of the third portion 115 interacts with the underlying bone after implantation, for example a superior surface of the humerus bone. The inferior outer surface of the third portion 315 forms an inferior outer surface of the implant 300.
[50] Additionally or optionally, the body 310 of the implant 300 may include a second portion (not shown) that is structurally and functionally similar to the second portion 113 of the implant 100.
[51] The plurality of elongate members 330 (hereinafter, the elongate members 330) may extrude inferiorly from a superior outer surface of the first portion 311 (and/or the second portion) of the body 310. The elongate members 330 may be circumferentially spaced around the body 310 of the implant 300. In an exemplary embodiment, as shown in Fig. 3, two elongate members 330 extrude inferiorly from the first portion 311 of the body 310.
[52] The elongate members 330 are made of a material including but not limited to titanium, cobalt chromium, SS316, etc. In an exemplary embodiment, the elongate members 330 are made of titanium.
[53] The elongate members 330 may have a pre-defined shape including but not limited to straight shaped, J-shaped, conical, etc. In an exemplary embodiment, as shown in Fig. 3, the elongate members 330 are straight shaped.
[54] The elongate members 330 are each provided with at least one hole 331. In an exemplary embodiment, each of the elongate member 330 are provided with two holes 331. Each hole 331 is configured to receive one fastener (described below).
[55] Fig. 3a depicts an exemplary fastener 333 of the present disclosure. The fastener 333 includes a head portion 333a and a shank portion 333b. The fastener 333 is made of a material including, but not limited to, titanium, cobalt chromium, SS316, etc. In an exemplary embodiment, the fastener 333 is made of titanium.
[56] The head portion 333a of the fastener 333 may have a pre-defined shape including but not limited to cylindrical, conical, frustum, etc. In an exemplary embodiment, as shown in Fig. 3a, the head portion 333a has a tapered shape. The head portion 333a may have a portion defining a diameter that is greater than the diameter of the hole 331 to prevent the fastener 333 to pass through the respective hole 331 of the elongate members 330.
[57] Additionally or optionally, the head portion 333a may have surface grooves/patterns (not shown) to enable a user to use a tool on the head portion 333a to rotate the fastener 333.
[58] In an exemplary embodiment, the shank portion 333b is cylindrical in shape. The shank portion 333b may be provided with one or more spirally/helically extending surface protrusions 333b1 (hereinafter, protrusion 333b1). The protrusion 333b1 helps to lodge the shank portion 333b of the fastener 333 in the bone (described later).
[59] Additionally or optionally, the shank portion 333b of the fastener 333 may be provided with a pointed tip 333b2 (as shown in Fig. 3a). The pointed tip 333b2 enables the fastener 333 to pierce through bony surfaces.
[60] Fig. 3b depicts the fastener 333 disposed across the holes 331 of the implant 300. As shown, the shank portion 333b is completely passed across the hole 331. And, the head portion 333a may at least partially be passed through the hole 331. The fastener 333 provides strong fixation of the implant 300 with the underlying bone after implantation. The fastener 333 helps to prevent rotational motion of the body 310 of the implant 300 after implantation.
[61] Fig. 4 depicts an exemplary method 400 to implant the implant 300 to a bone 30. The method 400 commences at step 401 by preparing the bone 30 to receive the implant 300. The bone 30 may optionally be resected to accommodate the implant 300. In an exemplary embodiment, a head of the humerus bone is resected corresponding to the profile/dimensions of the implant 300.
[62] The bone 30 is prepared by making a plurality of cavities 31 in the bone 30 as shown in Fig. 4a. In an exemplary embodiment, the number of cavities 31 made in the bone 30 corresponds to the number of holes 331 of the implant 300, i.e., for the implant 300 having four holes 331 (two holes 331 per elongate member 330), four cavities 31 are made in the bone 30. And, the cavities 31 have a shape corresponding to the shape of the fasteners 333 thus, providing strong fixation of the implant 300 after implantation. The cavities 31 helps in preventing any rotational motion (and/or dislocation) of the implant 300 with respect to the bone 30 after implantation.
[63] In an exemplary embodiment, the cavities 31 are made with a drill tool by a physician.
[64] At step 403, the implant 300 is positioned over the bone 30. The implant 300 is placed over the bone 30 such that an inferior outer surface of the third portion 315 of the body 310 interacts with a superior surface 33 (as shown in Fig. 4a) of the bone 30. And, the holes 331 of the implant 300 are aligned with respective cavity 31 of the bone 30.
[65] At step 405, the implant 300 is secured to the bone 30 with the help of the fasteners 333. At least a portion of the fasteners 333 is inserted into each of the cavities 31 of the bone 30 via the holes 331 of the implant 300 as shown in Fig. 4b.
[66] After the fasteners 333 are inserted into the respective hole 331 and cavities 31, the inferior outer surface of the implant 300 perfectly sits over the superior surface 33 of the bone 30. Further, the protrusion 333b1 helps to lodge the shank portion 333b of the fastener 333 in the cavity 31 of the bone 30 thereby firmly securing the implant 300 with the bone 30.
[67] Although the securement of the implant 300 is described with the help of fasteners 333, other functionally equivalent structures are also within the scope of the teachings of the present invention.
[68] 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 disclosure is/are used. , Claims:We claim,
1. An implant (100, 300) comprising:
a. a body (110, 310) including at least:
i. a first portion (111, 311) having a superior outer surface with a convex profile, and
ii. a third portion (115, 315) disposed inferior to the first portion (111), having an inferior outer surface with a predefined pattern formed thereon; and
b. a plurality of elongate members (130, 330) extending inferiorly from the body (110, 310), the plurality of elongate members (130, 330) circumferentially spaced around the body (110, 310).
2. The implant (100, 300) as claimed in claim 1, wherein the body (110, 310) includes a second portion (113) disposed inferior to the first portion (111, 311).
3. The implant (100, 300) as claimed in claim 1, wherein the inferior outer surface of the third portion (115, 315) has a trabecular lattice pattern formed thereon.
4. The implant (100, 300) as claimed in claim 1, wherein a pre-defined shape of the plurality of elongate members (130, 330) includes straight shaped, J-shaped, or conical.
5. The implant (300) as claimed in claim 1, wherein the first portion (111) is hemi-spherically shaped.
6. The implant (300) as claimed in claim 1, wherein each of the plurality of elongate members (330) are provided with at least one hole (331) configured to receive at least one fastener (333).
7. The implant (300) as claimed in claim 6, wherein the fastener (333) includes a head portion (333a) and a shank portion (333b).
8. The implant (300) as claimed in claim 6, wherein a head portion (333a) of the fastener (333) includes a portion defining a diameter that is greater than the diameter of the hole (331).
9. The implant (300) as claimed in claim 6, wherein a head portion (333a) of the fastener (333) has a pre-defined shape including cylindrical, conical, or frustum.
10. The implant (300) as claimed in claim 6, wherein a shank portion (333b) of the fastener (333) is provided with one or more surface protrusion (333b1) extending spirally or helically.
11. The implant (300) as claimed in claim 6, wherein a shank portion (333b) of the fastener (333) is provided with a pointed tip (333b2).
12. The implant (100, 300) as claimed in claim 1, wherein the body (110, 310) is made of a material including titanium, cobalt chromium, or stainless steel 316.
13. The implant (100, 300) as claimed in claim 1, wherein the elongate members (130, 330) are made of a material including titanium, cobalt chromium, or stainless steel 316.
14. The implant (100, 300) as claimed in claim 1, wherein the plurality of elongate members (130, 330) extends inferiorly from at least one of the superior outer surface of the first portion (311) and the inferior outer surface of the third potion (115) of the body (110, 310).