DESC: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:
OSTEO 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:

FILED OF THE INVENTION
[001] The present invention relates to an implant. More specifically, the present invention relates to a stem potion of an implant.
BACKGROUND OF THE INVENTION
[002] Naturally, a hip joint includes a femur bone (thigh bone) coupled to a pelvic bone via a ball and socket joint. People suffering from deteriorating hip joints undergo hip replacement surgery. In the hip replacement surgery, the hip joint is completely or partially replaced by a synthetic implant.
[003] A conventional implant or stem prosthesis, used to reinforce the femur bone in the hip replacement surgery, includes an axially extending stem portion and a neck portion that is at least partially disposed at an angle with respect to the stem portion. The stem prosthesis is inserted within a cavity of the femur bone. The neck portion indirectly connects the stem portion to the pelvic bone.
[004] Conventionally available stem prostheses are one of a monoblock type or a modular type. As the name suggests, the monoblock type stem prosthesis is formed by an integral structure of the neck portion and the stem portion. Monoblock stem prosthesis are easy to insert and have no risk of breakage. However, the monoblock stem prosthesis suffer from higher incidents of subsidence and inability to restore soft tissue tension.
[005] In contrast, the modular type stem prosthesis has a removably coupled neck portion and the stem portion. The modular stem prosthesis is relatively more resistant to subsidence compared to the monoblock stem prosthesis, however, more improvement in this direction is needed. In addition, the modular stem prosthesis provides better ability to achieve soft tissue balance. However, they are more cumbersome to insert within the bone and are prone to breaking where the stem portion and the neck portion are coupled.
[006] Further, conventional implants either fail to achieve adequate friction fit with the surrounding bone or are prone to fracture the bone. There is thus a need for an implant that obviates the above drawbacks.
SUMMARY OF THE INVENTION
[007] 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.
[008] The present disclosure relates to an implant. The implant includes a body towards its proximal end and an elongated portion towards its distal end. In an embodiment, the elongated portion includes a plurality of ribs extending along its length. The ribs include an angled orientation forming an angle with an axis of the elongated portion. In another embodiment, the elongated portion includes at least a channel extending at least partially around the surface of the elongated portion. In yet another embodiment, the elongated portion includes multiple angled ribs and at least one channel.
BRIEF DESCRIPTION OF DRAWINGS
[009] The summary above and the detailed description of descriptive embodiments, is better understood when read in conjunction with the apportioned drawings. For illustration of 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.
[0010] Fig. 1 depicts an implant 100, according to an embodiment of the present disclosure.
[0011] Fig. 1a depicts a portion of an elongated portion 110 of the implant 100, according to an embodiment of the present disclosure.
[0012] Fig. 1b depicts a distal tip 160 of the implant 100, according to an embodiment of the present disclosure.
[0013] Fig. 1c depicts a bottom perspective of the implant 100, according to an embodiment of the disclosure.
[0014] Fig. 2 depicts the implant 100, according to an alternate embodiment of the present disclosure.
[0015] Fig. 2a depicts a channel 112, according to an alternate embodiment of the present disclosure.
DETAILED DESCRIPTION OF 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] The implant of the present invention is designed to be installed in the femur of a patient during hip surgery. However, it is envisaged that at least some of the embodiments of this disclosure may instead apply to a humeral implant for shoulder surgery with some suitable adaptations. The configuration of the implant in such embodiments may be substantially as described below (particularly in relation to the ribs and channels), although the overall size and shape of the implant would be configured to allow it to be installed in a humerus instead of a femur. It is also envisaged that at least some embodiments of this invention may instead apply to a (distal) femoral implant or a tibial implant for knee surgery. Again, the configuration of the implant in such embodiments may be substantially as described below (particularly in relation to the ribs), although the overall size and shape of the implant would be configured to allow it to be installed in a tibia or distal femur instead of a proximal femur.
[0021] Similarly, it is envisaged that in some embodiments of this disclosure, the implant may be a trial component. The trial component may be used in a trialling procedure prior to installation of a proximal or distal femoral implant, tibial implant or humeral implant.
[0022] The implant of the present invention includes an elongated member. The elongated member includes a plurality of ribs extending at least partially along its length. The ribs are angled around the surface of the elongated member such that friction fit and stability between the implant and the bone is increased. Alternatively, the elongated member of the implant may include one or more channel(s) extending at least partially around its circumference. The channel(s) are configured to increase the stability of the implant inside the bone cavity by promoting bone ingrowth. The channel(s) also resolves the problem of sinking of the implant, thereby increasing longevity and effectiveness of the implant.
[0023] Now referring to the figures, Fig. 1 illustrates an embodiment of an implant 100 of the present disclosure. The implant 100 may be made of a pre-defined material like titanium, CoCr, stainless steel or any other suitable bio compatible metal or alloy. In an exemplary embodiment, the implant 100 is constructed from forged titanium alloy [Ti-6Al-4V-ELI]. The implant 100 includes a proximal end 100a, a distal end 100b and a length therebetween. The implant 100 includes a plurality of components such as an elongated portion 110, a body 120, a shoulder 130 and a neck 140. The elongated portion 110, the body 120, the shoulder 130 and the neck 140 can form an integral structure or can be suitably coupled to form the implant 100. The latter allows for modular construction of the implant to be achieved, mostly catering to differently sized modules (e.g. a larger or smaller elongated portion and/or elongate neck portion) as needed for performing the procedure. In an embodiment, the implant 100 is an integral structure.
[0024] The body 120 is disposed towards the proximal end 100a of the implant 100. In an exemplary embodiment, the body 120 and the elongated portion 110 form an integral structure. Alternately, the body 120 may be removably coupled to the elongated portion 110. Additionally or optionally, the body 120 is provided with one or more holes 121. In an exemplary embodiment, the holes 121 enable a user to attach a suture(s) to a trochanteric fragment (not shown). This trochanteric fragment can be a natural trochanter, an anatomical structure located on the upper portion of the femur. The holes 121 are used for fixing the stem with the natural trochanter using sutures.
[0025] The body 120 includes an outer surface which may be in direct contact with the femur bone (not shown) once implanted in the bone. The outer surface of the body 120 may be provided with at least one layer of coating. In an exemplary embodiment, the outer surface of the body 120 is provided with one layer of coating including but not limited to hydroxyapatite (HA), titanium coating, etc. The coating has chemical similarity to the minerals of a natural bone and thus, helps in enhanced bone-implant integration of the implant 100 and femur bone, after the implant 100 is inserted within the cavity of the bone. The coating further promotes regrowth of the hard tissue resulting in increased rate of osteointegration.
[0026] The shoulder 130 is disposed at the proximal end 100a of the implant 100. The shoulder 130 may include a recess (not shown). The recess can facilitate a user to couple additional attachments such as an augment, monomod applicator, stem inserter, slap hammer, etc. with the implant 100 using any suitable coupling mechanism such as a fastener, a rivet etc. The recess can be circular, semi-circular, oval, or any other suitable shape. Further, the wall of the recess may be threaded, semi-threaded or unthreaded. The recess extends at least partially along the length of the body 120. Further, the recess may be aligned with the center of the shoulder 130 or may be offset from the center by a predefined distance.
[0027] The neck 140 may have a proximal end and a distal end. The distal end of the neck 140 may join with the body 120 while the neck 140 may extend away from the body 120 of the implant 100. The proximal end of the neck 140 may include a connection feature or connection features for attaching a head portion of a femoral implant (or humeral implant, in the case of shoulder surgery) to the implant 100. Alternately, the proximal end of the implant 100 may be integrally formed with a femoral head portion. The neck 140 defines a pre-defined angle with the axis of the elongated portion 110. The said angle is based upon the orientation of the femur bone with an adjacent pelvic bone. The neck 140 indirectly forms a ball and socket joint with the pelvic bone. In an exemplary embodiment, not shown, the neck 140 is provided with a ball that is coupled to a native socket of the pelvic bone or an implant provided on the pelvic bone forming a ball and socket joint replicating the motion of the natural joint.
[0028] The elongated portion 110, also referred as a stem, is disposed towards the distal end 100b. The elongated portion 110 includes a distal tip 160 that defines the distal end 100b of the implant 100. The distal tip 160 of the implant 100 can include any suitable shape such as flat, rounded, pointed, forked, chiselled, etc. In an embodiment, the implant 100 includes a rounded distal tip 160 (Fig. 1b).
[0029] The elongated portion 110 may be tapered such that it is wider at its proximal end than at its distal end. The taper angle of the elongated portion 110 may, for instance, be around 2.5°. The elongated portion 110 has a longitudinal axis 150 (or axis), along which the elongated portion 110 extends. At least a portion of the elongated portion 110 may include a smooth or textured surface. When the implant 100 is installed, the longitudinal axis 150 may generally align with a longitudinal axis 150 of the femur (or the humerus, in the case of shoulder surgery, or the femur or tibia in the case of knee surgery).
[0030] In an embodiment, the elongated portion 110 includes a plurality of ribs 111. Each rib 111 has a distal end and a proximal end. The ribs 111 can include any suitable shape such as straight, tapered, flared, curved, etc. As can be seen in Figure 1a, the ribs 111 are of constant width. Alternately, the ribs 111 can be tapered. In this configuration, the rib 111 is narrower at a distal end than the proximal end. In yet another embodiment, some of the ribs 111 may be of uniform width while some of the ribs 111 may be tapered.
[0031] The ribs 111 extend at least partially along the length of the elongated portion 110. In an embodiment, the ribs 111 extend along the entire length of the elongated portion 110. Further, the ribs 111 are distributed across at least a portion of the circumference of the outer surface of the elongated portion 110. In an embodiment, the ribs 111 are distributed throughout the circumference of the outer surface of the elongated portion 110.
[0032] In an embodiment, the ribs 111 include an angled orientation (fig. 1c). The ribs 111 form an angle with an axis 150 of the elongated portion 110. The ribs 111 may form an angle ß with the axis 150. The angle ß can range from 0.1° to 90° (fig. 1a). In an embodiment, the angle ß is 3°. The angled orientation of the ribs 111 are configured to provide rotational resistance to the implant 100 and prevents the implant 100 from sinking inside a bone cavity. The ribs 111 are angled with respect to the axis 150 such that the friction between the bone and the implant 100 surface is maximum. The increased friction restricts any unwanted movement between the implant 100 and the bone and increases the stability and life of the implant 100.
[0033] In an alternate embodiment, the elongated member 110 includes at least one channel 112 along its surface. In an embodiment, the at least one channel extends around at least a portion of the outer surface of the elongated portion 110. In an exemplary embodiment, the elongated member 110 includes two channels as depicted in fig. 2. The channels 112 can be positioned anywhere along the length of the elongated member 110.
[0034] The shape of the channel 112 can include without limitation, a defined geometrical shape or a contoured shape. The geometrical shape includes without limitation, a circular shape, a triangular shape, etc while a contoured shape includes without limitation a wave, an undulating shape, a zig-zag shape, etc. In an embodiment, the channel 112 includes a circular shape as depicted in Fig. 2. Further, in case of multiple channels 112 on the elongated member 110, the shape of one channel may differ from the shape of another channel. For example, one channel may be circular while the second channel may be wavy.
[0035] Each channel 112 includes predefined dimensions including a depth, a length and a width. For example, a circular channel 112 as depicted in Fig. 2 has a width ‘W’, depth ‘D’ and a length equal to the circumference of the elongated member 110. While the depicted embodiment illustrates a channel 112 that extends a full circle or entire circumference of the elongated member 110, the length of the channel 112 may extend from a quarter of a circumference or more.
[0036] The depth ‘D’ of the channel 112 can extend at least partially into the height of the ribs 111 or beyond. For example, the depth ‘D’ can extend thru the height of the ribs 111 into the outer surface of the elongated member 110. That is, the depth ‘D’ of the channel 112 can extend thru the height of the ribs 111 and also at least partially inwards of the outer surface of the elongated member 110. Alternately, the depth ‘D’ of the channel 112 can extend thru partial height of the ribs 111. Similarly, the width ‘W’ of the channel 112 can very extending at least partially along the length of the elongated member 110.
[0037] The channels 112 can include a smooth or textured surface. In an embodiment, the channels 112 includes a textured surface to increase osseointegration. The channels 112 provide rotational resistance and additional stability the implant 100. After the surgical procedure, due to the presence of the channels, a bone tends to fuse easily with the surface of the implant 100 covering the channels 112 of the elongated member 110. Thus, providing stability and resistance to the implant 100 and preventing the implant 100 from sinking inside the bone cavity. The channels 112 can also act as a guide while extracting the implant 100.
[0038] 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.
[0039] For example, in case the implant is modular, it is possible that the elongated member is made of a plurality of stem portions. In such case, one or more stem portions may include the ribs and/or channels at least partially along their surface. Or, between two stem portions a see-through opening defining a channel is formed which the ribs as described above, are provided on the outer surface of the stem portions.
[0040] In another example, in this case the elongated member 110 depicts a near circular cross-section, it is possible that the elongated member 110 can depict a cross-section of any suitable shape such as square, triangular, rectangular, kite, rhombus, etc.
[0041] 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 body (120) disposed towards a proximal end (100a);
b. an elongated portion (110) disposed towards a distal end 100b, the elongated portion (110) being tapered such that it is wider at its proximal end than its distal end, the elongated portion (110) includes a plurality of ribs (111) extending at least partially along the length of the elongated portion (110) and distributed across at least a portion of the circumference of the outer surface of the elongated portion (110),
wherein the ribs (111) include an angled orientation, forming an angle ß with an axis (150) of the elongated portion (110).
2. The implant (100) as claimed in claim 1, wherein the implant (100) is made from a bio-compatible material.
3. The implant (100) as claimed in claim 1, wherein the angle ß between the axis (150) and the ribs (111) ranges between 0.1° to 90°.
4. The implant (100) as claimed in claim 1, wherein the elongated portion (110) includes at least one channel provided on its outer surface extending at least over a portion of the outer surface.
5. The implant (100) as claimed in claim 5, wherein the channel (112) is positioned along the length of the elongated member 110.
6. The elongated portion (110) as claimed in claim 5, wherein the channel (112) includes one of a defined geometrical shape or a contoured shape.
7. The elongated portion (110) as claimed in claim 7, wherein the geometrical shape includes, a circular shape, or a triangular shape.
8. The elongated portion (110) as claimed in claim 7, wherein the contoured shape includes a wave, an undulating shape, a zig-zag shape.
9. An implant (100) comprising:
a. a body (120) disposed towards a proximal end (100a); and
b. an elongated portion (110) disposed towards a distal end (100b), the elongated portion (110) includes at least one channel (112) on its outer surface extending at least over a portion of the outer surface.
10. The implant (100) as claimed in claim 9, wherein the channel (112) is positioned along the length of the elongated member 110.
11. The elongated portion (110) as claimed in claim 9, wherein the channel (112) includes one of a defined geometrical shape or a contoured shape.
12. The elongated portion (110) as claimed in claim 11, wherein the geometrical shape includes, a circular shape, or a triangular shape.
13. The elongated portion (110) as claimed in claim 11, wherein the contoured shape includes a wave, an undulating shape, a zig-zag shape.
14. The implant (100) as claimed in claim 9, wherein the elongated portion (110) includes a plurality of ribs (111) extending at least partially along the length of the elongated portion (110) and distributed across at least a portion of the circumference of the outer surface of the elongated portion.
15. The implant (100) as claimed in claim 14, wherein the ribs (111) include an angled orientation, forming an angle ß with an axis (150) of the elongated portion (110).
16. The implant (100) as claimed in claim 9, wherein the elongated portion (110) is tapered such that it is wider at its proximal end than its distal end.
17. The implant (100) as claimed in claim 9, wherein the channel (112) includes a depth ‘D’ that ranges from at least partially the height of the ribs (111) or beyond.