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:
STEM 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 stem implant. More particularly, the present disclosure relates to a stem implant capable of laser-induced extraction.
BACKGROUND OF INVENTION
[2] In-bone implants (for example, stem implants), after a long period of implantation, undergo osteointegration. Osteointegration is a process of bone in-growth on the surface of the implant. Osteointegration is preferred and critical for implant stability as it provides rigid fixation of the artificial implant with the bone.
[3] In some cases, where implants are placed in a patient’s body, after a certain amount of time, a revision surgery is needed. The reasons for revision surgery include dislocation, poor fit, infection, decreased activity, and decreased mobility, which lead to a reduced quality of life for patients.
[4] During the revision surgery, the old implant is extracted and replaced with a new implant. However, due to the osteointegration of the old implant, it is very difficult for a medical practitioner to safely and easily extract the old implant. Further, due to the osteointegration of the old implant, the extraction procedure may sometimes cause medical complications as it can damage the bone and/or the surrounding tissues.
[5] Hence, there arises a need for an implant that overcomes the drawbacks 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 an upper body disposed at a proximal end, one or more optical fibers, a lower body disposed at the distal end, and a disc disposed between the upper body and the lower body. The upper body including one or more openings that extend through the length of the upper body. The optical fibers are disposed in the corresponding openings. The optical fibers being coupled to an external laser for receiving a laser. The disc includes at least one groove towards the proximal end and configured to at least partially receive the optical fiber from the openings of the upper body. The disc includes a plurality of openings disposed towards the distal end. Each of the plurality of openings is operationally coupled to the optical fibers. The laser is configured to emerge out of the plurality of openings of the disc.
BRIEF DESCRIPTION OF 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] Figs. 1 and 1a depict a stem implant/ implant 100 according to an embodiment of the present disclosure.
[10] Fig. 2 depicts a cross-sectional view of the stem implant 100 according to an embodiment of the present disclosure.
[11] Fig. 2a depicts an enlarged view of the coupling between the components of the stem implant 100 according to an embodiment of the present disclosure.
[12] Figs. 3 and 3a depict an exploded view of the stem implant 100 according to an embodiment of the present disclosure.
[13] Fig. 3b depict a top view of an upper body 110 of the stem implant 100 according to an embodiment of the present disclosure.
[14] Fig. 4 depicts a disc 120 of the stem implant 100 according to an embodiment of the present disclosure.
[15] Fig. 4a depicts a bottom view of the disc 120 of the stem implant 100 according to an embodiment of the present disclosure.
[16] Fig. 4b depicts a cross-sectional view of the disc 120 of the stem implant 100 according to an embodiment of the present disclosure.
[17] Fig. 5 depicts a method 500 of extracting the stem implant 100 according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[18] 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.
[19] 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.
[20] 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.
[21] 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.
[22] The present disclosure relates to a stem implant (or implant). The implant may be implanted within at least one of a femoral bone, a humeral bone, etc.
[23] In an embodiment, the implant includes an upper body, a lower body and a disc therebetween. The upper body includes at least two optical fibers. The optical fibers help to deliver a laser from the upper body to the disc. The disc helps to distribute the laser around an outer surface of the lower body thereby loosening the implant from an implantation site. The laser emerges out of the disc and breaks the bone in-growth around the outer surface of the lower body, thereby facilitating easy extraction. Thus, the implant provides precise and secure removal without risk of bone/surrounding tissue damage.
[24] Now, referring to figures, Fig. 1 depicts an implant 100, according to an embodiment of the present disclosure. The implant 100 includes a proximal end 100a and a distal end 100b. The implant 100 includes an upper body 110, a disc 120 (as shown in Fig. 1a), and a lower body 130.
[25] The upper body 110 (as shown in Fig. 2 and Fig. 2a) is disposed at the proximal end 100a of the implant 100. The upper body 110 is made of a material including but not limited to, titanium, cobalt-chromium (co-cr), high nitrogen stainless steel (HNSS), etc. In an exemplary embodiment, the upper body 110 is made of titanium. The dimensions of the upper body 110 may vary according to or based upon the anatomy of the patient and/or of the patient population in consideration. The upper body 110 extends between the proximal end 100a and a distal end 110a.
[26] The upper body 110 at its proximal end 100a includes a leg extension 110b. The leg extension 110b has a pre-defined shape such as, without limitation, conical, tapered, trapezoidal and the like. In an exemplary embodiment, the shape of the leg extension 110b is tubular. The leg extension 110b helps in assembly of the implant 100 with a modular head (not shown).
[27] The upper body 110 is provided with one or more openings 111a (as shown in Figs. 3a and 3b) that run from the proximal end 100a to the distal end 110a. The openings 111a extends through the length of the upper body (110). At least one optical fiber 111 is disposed in the corresponding openings 111a. At the proximal end 100a, the optical fiber 111 is coupled to an external laser source for receiving a laser.
[28] The optical fiber 111 is made of a material including, but not limited to, poly methyl methacrylate (PMMA), silicon dioxide, any plastic material, etc. In an exemplary embodiment, the optical fiber 111 is made of poly methyl methacrylate (PMMA). The optical fiber 111 helps to deliver the laser from the proximal end 100a of the implant 100 to the disc 120 of the implant 100.
[29] The distal end 110a of the upper body 110 is provided with a cavity 113 (as shown in Figs. 3 and 3a). In an exemplary embodiment, the cavity 113 is disposed at a center (along a longitudinal axis) of the upper body 110. Alternately, the cavity 113 may be distanced from the center and along the longitudinal axis. The cavity 113 may be provided at least partially with a plurality of threads. The cavity 113 helps to couple the lower body 130 to the upper body 110 (explained later).
[30] The disc 120 (as shown in Figs. 3 and 3a) is placed at the distal end 110a of the upper body 110. The disc 120 is disposed between the upper body 110 and the lower body 130. The disc 120 is made of a material including, but not limited to, poly methyl methacrylate (PMMA), silicon dioxide, any plastic material, etc. In an exemplary embodiment, the disc 120 is made of poly methyl methacrylate (PMMA). The dimensions of the disc 120 may vary according to or based upon dimensions of the upper body 110, the anatomy of the patient and/or of the patient population in consideration. The disc 120 has a pre-defined shape similar to an outer surface of the lower body 130. In an exemplary embodiment, the disc 120 has a circular shape.
[31] The disc 120 is provided with a hole 121. The hole 121 is aligned with the cavity 113 of the upper body 110 (as shown in Figs. 3 and 3a). In the depicted embodiment, the hole 121 is at the center aligned with the cavity 113 of the upper body 110. However, the hole 121 may be distanced from the center corresponding to the cavity 113 of the upper body 110.
[32] A proximal end 120a of the disc 120 is provided with at least one groove 123. In an exemplary embodiment, as shown in Fig. 4, the groove 123 is disposed circumferentially around the hole 121 at a predefined distance away from the hole 121. The openings 111a of the upper body 110 at least partially align with the groove 123 (as shown in Fig. 2a). Therefore, the distal end of the optical fibers 111 that pass through the openings 111a of the upper body 110, is at least partially received within the groove 123. Due to this arrangement, the laser is delivered within the groove 123 of the disc 120 by the optical fibers 111. Further, the groove 123 helps to uniformly distribute the laser circumferentially and uniformly throughout the groove 123. Although the disc 120 is described with the example of grooves 123 being disposed circumferentially, other configurations of the groove 123 are within the scope of the teachings of the present disclosure.
[33] An outer surface of the disc 120 is provided with a plurality of openings 125 at the distal end 120b of the disc 120 (as shown in Fig. 4a). The openings 125 are disposed at an outer periphery of the disc 120. As shown in Figs. 2a and 4b, each of the plurality openings 125 are operationally coupled to the grooves 123 (and the optical fibers 111) via a lumen 125a. Alternatively, each opening 125 is coupled to the groove 123 via a respective lumen (not shown). In an exemplary embodiment, as shown in Fig. 4b, the lumen 125a extends from the openings 125 of the disc 120 to the groove 123 of the disc 120. The lumen 125a may have any pre-defined shape. In an exemplary embodiment, as shown in Fig. 4b, the lumen 125a is L-shaped. Other functionally equivalent structures/mechanism to couple the openings 125 to the groove 123 are within the scope of the teachings of the present disclosure. The openings 125 may be angled such that they are directed towards the outer surface of the lower body 130. Alternately, the openings 125 may be distanced from the outer periphery of the disc 120.
[34] Each of the optical fiber 111 is operationally coupled to the openings 125 of the disc 120, for example, via the groove 123 and the lumen 125a. The laser is emitted from an external source, and passes through the optical fiber 111 (as shown in Fig. 2a) to the grooves 123. Thereafter, the laser is uniformly distributed throughout the groove 123 and passes to the openings 125 of the disc 120 through the lumen 125a.
[35] In an exemplary embodiment, as shown in Figs. 3a and 4a, the outer surface of the disc 120 is provided with a plurality of axially extending ribs 127. The ribs 127 extend longitudinally along at least a portion of the length of the disc 120. The ribs 127 help in better fixation of the implant 100 at the implantation site.
[36] In an alternate embodiment, not shown, the outer surface of the disc 120 is smooth and continuous.
[37] The lower body 130 is disposed at the distal end 100b of the implant 100 (as shown in Fig. 3). The lower body 130 is made of a material, including, but not limited to, titanium, co-cr, HNSS, etc. In an exemplary embodiment, lower body 130 is made of titanium. The dimensions of the lower body 130 may vary according to or based upon the anatomy of the patient and/or of the patient population in consideration. In an exemplary embodiment, the lower body 130 has a tubular shape.
[38] The lower body 130 is provided with an axially extending projection 131 disposed towards the proximal end 130a of the lower body 130 (as shown in Fig. 3a). The projection 131 is aligned with the cavity 113 of the upper body 110 (as shown in Figs. 3 and 3a). In the depicted embodiment, the projection 131 is at the center aligned with the cavity 113 of the upper body 110. However, the projection 131 may be distanced from the center corresponding to the cavity 113 of the upper body 110. The projection 131 may extend axially (along a longitudinal axis of the lower body 130) towards the distal end 110a of the upper body 110. The projection 131 may be provided with a plurality of threads. In an exemplary embodiment, the projection 131 is conical in shape (as shown in Fig. 2).
[39] The projection 131 is configured to pass through the hole 121 of the disc 120. Thereafter, the projection 131 is disposed at least partially within the cavity 113 of the upper body 110. The plurality of threads of the projection 131 is engaged with the plurality of threads of the cavity 113, thereby coupling the upper body 110, the disc 120 and the lower body 130 together with each other. Although the coupling between the projection 131 and cavity 113 is described with the example of plurality of threads, other functionally equivalent techniques of coupling the upper body 110, the disc 120 and the upper body 110 are within the scope of the teachings of the present disclosure.
[40] In an exemplary embodiment, as shown in Fig. 3, the outer surface of the lower body 130 is provided with a plurality of axially extending ribs 133. The ribs 133 extend longitudinally along at least a portion of the length of the implant 100. The ribs 133 help in improved fixation of the implant 100 at the implantation site. As shown in Fig. 1a, each of the ribs 133 of the lower body 130 align with respective ribs 127 of the disc 120.
[41] In an alternate embodiment, not shown, the outer surface of the lower body 130 is smooth and continuous corresponding to the outer surface of the disc 120.
[42] The laser emerges out of the disc 120 via the openings 125 and breaks the bone-in growth around the outer surface of the lower body 130 of the implant 100, thereby loosening the implant 100 from the implantation site, and enabling the medical practitioner to easily extract the implant 100. In an exemplary embodiment, the laser is configured to incrementally erode the bone-in growth around the outer surface of the lower body 130 along an entire length of the lower body 130.
[43] Fig. 5 depicts an exemplary method 500 of extracting the implant 100 from the implantation site.
[44] The method 500 commences at step 501, by providing the laser within the optical fiber 111 via the opening 111a of the upper body 110.
[45] At step 503, the laser is transferred to the groove 123 of the disc 120 by the optical fibers 111. The groove 123 helps to uniformly distribute the laser received from the openings 111a of the upper body 110 throughout the groove 123.
[46] At step 505, the groove 123 of the disc 120 directs the laser to each of the openings 125 of the disc 120 via, for example, the lumen 125a.
[47] At step 507, the laser emerges out of the disc 120 via the openings 125 and incrementally breaks the bone-in growth around the outer surface of the lower body 130 of the implant 100, thereby loosening the implant 100 from the implantation site.
[48] At step 509, the implant 100 is easily extracted from the implantation site without damaging the bone and/or the surrounding tissue.
[49] The foregoing description of preferred embodiments of the present disclosure provides illustration and description, but is not intended to be exhaustive or to limit the disclosure to the precise form disclosed. Modifications and variations are possible in light of the above teachings or may be acquired from practice of the disclosure.
[50] 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 proximal end (100a) and a distal end (100b);
b. an upper body (110) disposed at the proximal end (100a), the upper body (110) including one or more openings (111a) that extend through the length of the upper body (110);
c. one or more optical fibers (111) disposed in the corresponding openings (111a), the optical fibers (111) being coupled to an external laser for receiving a laser;
d. a lower body (130) disposed at the distal end (100b), and
e. a disc (120) disposed between the upper body (110) and the lower body (130), the disc (120) includes at least one groove (123) towards the proximal end (100a) configured to at least partially receive the optical fiber (111) from the openings (111a) of the upper body (110), the disc (120) includes a plurality of openings (125) disposed towards the distal end (100b), each of the plurality of openings (125) is operationally coupled to the optical fibers (111);
wherein, the laser is configured to emerge out of the plurality of openings (125) of the disc (120).
2. The implant (100) as claimed in claim 1, wherein at least one of the outer surface of the disc (120) and the lower body (130) is provided with a plurality of axially extending ribs (127,133).
3. The implant (100) as claimed in claim 1, wherein the openings (125) are directed towards an outer surface of the lower body (130).
4. The implant (100) as claimed in claim 1, wherein the distal end (100b) of the upper body (110) is provided with a cavity (113).
5. The implant (100) as claimed in claim 1, wherein the proximal end (100a) of the lower body (130) is provided with an axially extending projection (131).
6. The implant (100) as claimed in claim 1, wherein the disc (120) is provided with a hole (121).
7. The implant (100) as claimed in claims 4, 5 and 6, wherein the projection (131) is configured to pass through the hole (121) of the disc (120) and be disposed at least partially within the cavity (113) of the upper body (110).
8. The implant (100) as claimed in claim 4, wherein at least one of the cavity (113) and the projection (131) is provided with a plurality of threads.
9. The implant (100) as claimed in claim 5, wherein openings (125) is coupled to the groove (123) via a lumen (125a).
10. The implant (100) as claimed in claim 1, wherein the optical fiber (111) is made with at least one of poly methyl methacrylate (PMMA), silicon dioxide, or any plastic material.