Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

TITLE OF THE INVENTION
ADJUSTABLE FIXTURE ELEMENTS FOR AN ORTHOPEDIC IMPLANT

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:

FIELD OF INVENTION
[1] The present disclosure relates to an orthopedic implant. More particularly, the present disclosure relates to one or more adjustable fixture elements for a bone plate.
BACKGROUND OF INVENTION
[2] Bone fractures are common injuries, pose significant challenges to patients and healthcare professionals alike. Orthopedic surgeons utilize bone implants to stabilize fractures and facilitate the healing process.
[3] Conventional bone implants typically include a rigid structure with pre-drilled holes for bone screws into the bone to provide rigid fixation and support across the fracture site. But there are complications associated with locking the bone plate with the bone in cases of patient specific anatomical variations or complex fracture patterns. Differences in bone shape, size, curvatures and density of the bone brings challenge for achieving optimal fixation. For example, the standard configuration of the pre-drilled hole may not adequately address the unique geometry of the bone, leading to suboptimal alignment, stability or biomechanical support. Conventional bone plates, with fixed hole configurations provide limited adjustability, as a result these bone plates struggle to accommodate the intricacies of complicated fractures. This may lead to mechanical failure due to factors such as, improper alignment, or excessive stress on the implant. This can result in loosening or breakage of the plate, compromising its ability to stabilize the fracture and necessitating a revision surgery.
[4] Thus, there arises a need for a bone implant that overcomes challenges with conventional ones.
SUMMARY OF INVENTION
[5] 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.
[6] The present disclosure relates to an adjustable fixture element including a first adjustable fixture element seated within a slot provided in a plate. The first adjustable fixture element is configured to slide within a cavity of the slot, thereby adjusting the position of the first adjustable fixture element within the slot. The first adjustable fixture element includes a ring having a hole. The ring includes a body defining an outer circumference. The ring includes a protrusion encircling the outer circumference that is configured to move within a cavity of the slot. A top surface of the ring has an undulating surface provided with alternating sections of one or more trough regions and one or more peak regions.
BRIEF DESCRIPTION OF DRAWINGS
[7] 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.
[8] Fig. 1a-1b depicts a perspective view of a plate 110 of an implant 100 in accordance with an embodiment of the present disclosure.
[9] Fig. 2 depicts an assembled view of the implant 100 in accordance with an embodiment of the present disclosure.
[10] Fig. 3a depicts an isometric view of a first adjustable fixture element of the implant 100 in accordance with an embodiment of the present disclosure.
[11] Fig. 3b depicts a cross-sectional view of the first adjustable fixture element of the implant 100 in accordance with an embodiment of the present disclosure.
[12] Fig. 3c depicts a perspective view of a second adjustable fixture element of the implant 100 in accordance with an embodiment of the present disclosure.
[13] Fig. 4 depicts a perspective view of a plate 410 of an implant 400 in accordance with another embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[1] 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.
[2] 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.
[3] 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.
[4] 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.
[5] The present disclosure relates to at least one adjustable fixture element to be used with a bone plate. The plate includes a slot configured to receive the at least one adjustable fixture element. The adjustable fixture elements include at least one first adjustable fixture element, and at least one second adjustable fixture element. The first adjustable fixture element and the second adjustable fixture element may be individually provided in the slot of the bone plate or in combination. The first adjustable fixture element includes one or more ring that is movable and allows passage of a screw (for example, threaded screws or cortical screws) to a bone of a patient. The second adjustable fixture element includes one or more blocks (or block) provided in the slot of the bone plate, distributed between the rings. In an embodiment, the first adjustable fixture element and the second adjustable fixture element are slidable within the slot of the plate. The second adjustable fixture element acts as a stopper for the ring and prevents the movement of the ring from its position post fixation of the ring with the bone. Further, the second adjustable fixture element provides structural support to the plate and distributes uniform load on the bone during physiological activity.
[6] In an embodiment, the adjustability of the first adjustable fixture element and the second adjustable fixture element is enabled by the ability of the first adjustable fixture elements and the second adjustable fixture element to move or slide along the length of the slot provided on the bone plate. This sliding functionality of the adjustable fixture elements allows for precise positioning and alignment of the fixture elements to a desired location where screw fixation is required, thereby customizing the location of screw fixation to precisely accommodate the exact underlying anatomy of a patient. Further, the sliding functionality facilitates customizable configurations designed to suit a diverse range of anatomical variations and surgical requirements. For instance, in cases where a patient's anatomy presents unusual bone angles or dimensions, the surgeon may need to adjust the position of the screw fixation to ensure optimal stability and alignment during the surgical procedure. The ability to customize the placement of the fixture components according to such specific anatomical variations is essential for achieving successful surgical outcomes and minimizing the risk of complications.
[7] Unlike the conventional implants where during fixation of the bone plate to an underlying bone, a surgeon is required to fix a screw according to predefined holes provided on the plate, the adjustable fixture elements of the present disclosure allow the surgeon to slide and adjust the ring and/or the block within the slot of the plate, as needed to align and fix screws at a desired location with high precision. The adjustable fixture elements thus allow the surgeon to customize screw fixation at the desired location depending upon exact underlying anatomy of a patient. As a result, the risk of inadequate fixation, improper alignment and excessive stress built by the plate on the bone is reduced, thereby reducing the risk of loosening or breakage of the plate and enhancing its ability to repair the fracture speedily.
[8] The adjustable fixture elements can be provided with any bone plate having a longitudinal slot. The teachings of the adjustable fixture elements of the present invention are detailed below in the context of a humeral bone plate only as exemplary depiction and extend to any and every bone plate.
[9] Now referring to the figures, Fig. 1a depicts a bone implant 100 (hereinafter, implant 100) according to an embodiment. In an embodiment, the implant 100 is a humeral bone implant. Though the disclosure has been explained in the context of a humeral bone implant, it should be appreciated that the teachings of the present disclosure can be applied to other bone implants. In an exemplary embodiment, the implant 100 includes a plate 110 and one or more adjustable fixture elements. The depicted plate 110 is fixed to a humeral bone of a patient with the help of the adjustable fixture elements during the implantation procedure.
[10] The plate 110 extends from a proximal end 110a to distal end 110b, thereby defining a length having a thickness T1. The depicted plate 110 has smooth edges and the distal end 110b is tapered for minimal tissue irritation. The plate 110 may be made of any suitable biocompatible materials, such as, without limitation, titanium, titanium alloy, cobalt chromium alloy, stainless steel 316 (SS316) etc., or combinations thereof. In an embodiment, the plate 110 is made of titanium.
[11] The plate 110 includes a proximal portion 110c and a distal portion 110d. In an embodiment, the distal portion 110d exhibits slender profile compared to the proximal portion 110c, i.e., the proximal portion 110c has a broader width than the distal portion 110d. The distal portion 110d of the plate 110 includes a slot 120 that may extend throughout the distal portion 110d of the plate 110 having a length L1 and width W1. Though the present disclosure is explained using a plate having a slot provided at a distal portion of the plate, the teachings of the present invention extend to plates including a slot in the proximal portion, distal portion or in any portion extending therebetween.
[12] The slot 120 is configured to receive at least one adjustable fixture element, as explained below. That is, the at least one adjustable fixture elements are seated within the slot 120. In an embodiment, the slot 120 includes a cavity 122 (as shown in Fig. 1b). The cavity 122 includes a depth P and thickness T2. The at least one adjustable fixture element is seated within the depth P of the cavity 122 of the slot 120. The length L1 and thickness T1 of the slot 120 vary on numerous factors including the dimensions of the plate 110, the number of adjustable fixture elements needed, etc. while the depth P of the cavity 122 may depend upon one or more of the width or thickness T1 of the plate 110, etc. In an embodiment, the ends of the slot 120 are curved to allow effective coupling of the at least one adjustable fixture element with the slot 120.
[13] Fig. 2 illustrates an assembled view of the implant 100, according to an embodiment of the present disclosure. The adjustable fixture elements include at least one first adjustable fixture element, and at least one second adjustable fixture element. The first adjustable fixture element and the second adjustable fixture element may be individually provided in the slot 120 of the bone plate 110 or in combination. The first adjustable fixture element includes a ring 140 (hereinafter, the ring 140) seated within the slot 120 of the bone plate 110 that allows passage of a screw (for example, threaded screws or cortical screws) to a bone of a patient. The second adjustable fixture element includes a block 180 (hereinafter, the block 180) seated within the slot 120 of the bone plate 110. The block 180 may be distributed between two rings 140 or in proximity of the ring 140.
[14] One embodiment of the at least one adjustable fixture element is illustrated in Fig. 2. In the depicted embodiment, the adjustable fixture elements include three rings, namely, a first ring 140a, a second ring 140b and a third ring 140c (collectively referred to as the ring 140) and a block 180 (hereinafter, the block 180), as depicted in Fig. 2.
[15] Though the present disclosure is explained using a bone plate having fixture elements including three rings and one block, the teachings of the present invention extend to bone plates having one or more rings, one or more blocks or combinations thereof. Additionally, it is possible that the at least one adjustable fixture element may include at least one first adjustable fixture element, optionally accompanied by at least one second adjustable fixture element, or combination thereof.
[16] The ring 140 and the block 180 are configured to slide within the slot 120 of the plate 110. In an embodiment, the adjustability of the ring 140 and the block 180 is enabled by the ability of the ring 140 and the block 180 to move or slide along the length of the slot 120 provided on the bone plate 110. This sliding functionality of the adjustable fixture elements allows for precise positioning and alignment of the fixture elements to a desired location where screw fixation is required, thereby customizing the location of screw fixation to precisely accommodate the exact underlying anatomy of a patient. Further, the sliding functionality of the adjustable fixture elements facilitate customizable configurations designed to suit a diverse range of anatomical variations and surgical requirements.
[17] One embodiment of the ring 140 is illustrated in Fig. 3a. The ring 140 includes a hole 144, a body 142a, a top surface 142b, an inner surface 142c and a bottom surface (not shown). The dimensions of the ring 140 may vary depending upon the slot 120 of the plate 110 which in turn may vary depending on patient's anatomy of bone. The ring 140 may be made of any suitable biocompatible material, such as, but not limited to, titanium, titanium alloy, cobalt chromium alloy, stainless steel 316 (SS316) etc., or a combination thereof. In an embodiment, the ring 140 is made of titanium.
[18] The body 142a defines an outer circumference. A protrusion 146 encircles the circumference of the body 142a. The protrusion 146 may be provided towards the top surface 142b of the ring 140, bottom surface of the ring 140 or anywhere in between the two along the width of the ring 140 on the outer circumference. The protrusion 146 is configured to move within the cavity 122 of the slot 120 as the dimensions of the protrusion 146 complement the dimensions of the cavity 122 of the slot 120. The protrusion 146 may include a uniform thickness T3 or taper from an attached end 146a (end where the protrusion 146 is attached to the outer circumference of the ring 140) to a free end 146b (the end away from the outer circumference of the ring 140 and free).
[19] In an embodiment, the top surface 142b of the ring 140 includes an undulating surface. The undulating surface includes alternating sections of peak regions and trough regions that create a wavy appearance. For example, and a portion A of the top surface 142b has a gradual trough (hereinafter, trough region A) and a portion B of the top surface 142b has a gradual peak (hereinafter, peak region B). The undulating surface of the top surface 142b results in varying width of the ring 140 at different portions. For example, the width of the ring 140 in the trough region A is smaller than the width of the peak region B.
[20] Further, the width of the ring 140 in the peak region B is greater than the thickness of the cavity 122 of the slot 120 provided on the plate 110. Due to this interference locking is achieved as explained below.
[21] The ring 140 may be adjusted to position the ring 140 at a desired spot in the slot 120 by sliding the ring 140 back or forth along the length of the slot 120. During this adjustment process, the trough region A of the ring 140 is seated inside the cavity 122. Once at the desired spot, the ring 140 may be gradually rotated. This causes transition of the trough region A with the increasing curve leading to the peak region B. As the width of the ring 140 at the peak region A is greater than the thickness of the cavity 122 of the slot 120, the ring 140 is securely fixed to the plate 110 by creating an interference lock between the ring 140 and the cavity 122, preventing any further rotation of the ring 140. Thus, the undulating surface of the top surface 142b helps in securing the ring 140 within the cavity 122 of the slot 120.
[22] The inner surface 142c has an inner circumference. The inner circumference defines the hole 144 in the ring 140. The hole 144 allows passage of any suitable screw. In the depicted embodiment, the inner surface 142c of the ring 140 is devoid of threads and is configured to receive threaded/unthreaded screws. Alternately, the inner surface 142c may be threaded or semi-threaded. The threads of the inner surface 142c mate with threads of the screw.
[23] The ring 140 may be made of any suitable biocompatible materials, such as, without limitation, titanium, titanium alloy, cobalt chromium alloy, stainless steel 316 (SS316) etc., or combinations thereof. In an embodiment, the ring 140 is made of titanium.
[24] In an embodiment, the inner surface 142c of the ring 140 is tapered at a portion D, as shown in Fig 3a-3b. Tapering of the inner surface 142c helps in achieving proper alignment of screws with respect to the bone during angulation screwing and guides the screws into optimal positions relative to the bone surface, facilitating accurate placement and enhancing stability of the fixation. The utilization of angulation screwing techniques in orthopedic surgery is well-known in the field, with several known methods recognized by practitioners. These techniques, already acknowledged in the field of orthopedic knowledge, includes a range of approaches, such as, multiplanar screw insertion, oblique screw insertion, lag screw technique, interfragmentary screw fixation, and parallel screw insertion etc.
[25] Fig. 3c depicts a block 180, according to an embodiment of the present disclosure. The block 180 may be of any suitable shape, such as, without limitation, cuboidal, cylindrical, angular geometrical shape etc. In an embodiment, the block 180 has a rectangular cross-section. The block 180 has a top surface 182a, a bottom surface 182b, a first side 182c, a second side 182d, a third side 182e and a fourth side 182f, as shown in Fig. 3c. The dimensions of the block 180 may vary depending upon the slot 120 of the plate 110 which may further depend upon the patient’s anatomy. The first side 182c and the second side 182d of the block 180 is configured to slide within the slot 120 of the plate 110. In an embodiment, the top surface 182a has curvature. The curvature of the top surface 182a ensures proper fixation of the block 180 in the slot 120 and restricts the movement of the block 180 within the slot 120. The bottom surface 182b of the block 180 provides support and uniform load distribution to the bone.
[26] The block 180 may act as a stopper for the ring 140 and prevent delocalization of the ring 140 from its screwed position. Further, the block 180 enhances structural integrity of the implant 100. The block 180 may be made of any suitable biocompatible materials, such as, without limitation, titanium, cobalt chromium, Stainless steel 316 (SS316) etc., combinations thereof. In an embodiment, the block 180 is made of titanium.
[27] Another embodiment of the implant having multiple adjustable fixture elements is illustrated in Fig. 4. The implant 400 is a femoral bone plate 410. In the depicted embodiment, the adjustable fixture elements include three first adjustable fixture elements (or rings), namely, a first ring 140a, a second ring 140b and a third ring 140c (collectively referred to as the ring 140) and a second adjustable fixture element (or block) 180 (hereinafter, the block 180), as depicted in Fig. 4. The structure, functioning, etc. of the first and second adjustable fixture elements can be referred from above as described in the context of humeral bone plate and the same have not been repeated for the sake of brevity.
[28] 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 adjustable fixture element comprising:
a) a first adjustable fixture element having a ring (140) seated within a slot (120) provided in a plate (110), the ring (140) having a hole 144 and configured to slide within the slot (120) of the plate (110), the ring (140) includes;
I. a body (142a) defining an outer circumference;
II. a protrusion (146) encircling the outer circumference, configured to move within a cavity (122) of the slot (120); and
III. a top surface (142b) having an undulating surface provided with alternating sections of one or more trough regions (A) and one or more peak regions (B) resulting in difference of width of the ring (140) at different portions;
wherein the ring (140) is slidable along the length of the slot (120) of the plate (110), thereby adjusting the position of the ring (140) within the slot (120).
2. The adjustable fixture element as claimed in claim 1, wherein the width of the ring (140) in the trough region (A) is smaller than the width of the peak region (B) and the width of the ring (140) in the peak region (B) is greater than the thickness of the cavity (122) of the slot (120) provided in the plate (110).
3. The adjustable fixture element as claimed in claim 1, wherein the ring (140) creates an interference lock with the slot (120) of the plate (110) upon transition of the trough region (A) of the ring (140) to the peak region (B) of the ring (140) within the cavity (122).
4. The adjustable fixture element as claimed in claim 1, wherein the hole (144) in the ring (140) includes a tapered inner surface (142c) to achieve proper alignment of a screw with respect to the bone during angulation screwing.
5. The adjustable fixture element as claimed in claim 1, wherein an inner surface (142c) of the ring (140) is one of threaded, semi-threaded or unthreaded.
6. The adjustable fixture element as claimed in claim 1, wherein the protrusion (146) includes one of a uniform thickness (T3) or a taper from an attached end (146a) to a free end (146b).
7. An implant 100 having multiple adjustable fixture elements, the adjustable fixture elements comprising:
a. at least one first adjustable fixture element, the first adjustable fixture element including a ring (140) seated within a slot (120) provided in a plate (110), the ring (140) having a hole (144) and configured to slide within the slot (120) of the plate (110), the ring (140) includes:
i. a body (142a) defining an outer circumference;
ii. a protrusion (146) encircling the outer circumference, configured to move within a cavity (122) of the slot (120); and
iii. a top surface (142b) having an undulating surface provided with alternating sections of one or more trough regions (A) and one or more peak regions (B) resulting in difference of width of the ring (140) at different portions; and
b. at least one second adjustable fixture element, the second adjustable fixture element having a block (180) seated within the slot (120) of the plate (110), configured to stop delocalization of the ring (140) from its screwed position;
wherein the ring (140) and the block (180) are slidable along the length of the slot (120) of the plate (110), thereby adjusting the position of the ring (140) and the block (180) within the slot (120).
8. The adjustable fixture element as claimed in claim 7, wherein the width of the ring (140) in the trough region (A) is smaller than the width of the peak region (B) and the width of the ring (140) in the peak region (B) is greater than the thickness of the cavity (122) of the slot (120) provided in the plate (110).
9. The adjustable fixture element as claimed in claim 7, wherein the ring (140) creates an interference lock with the slot (120) of the plate (110) upon transition of the trough region (A) of the ring (140) to the peak region (B) of the ring (140) within the cavity (122).
10. The adjustable fixture element as claimed in claim 7, wherein the hole (144) in the ring (140) includes a tapered inner surface (142c) to achieve proper alignment of a screw with respect to the bone during angulation screwing.
11. The adjustable fixture element as claimed in claim 7, wherein an inner surface (142c) of the ring (140) is one of threaded, semi-threaded or unthreaded.
12. The adjustable fixture element as claimed in claim 7, wherein the protrusion (146) includes one of a uniform thickness (T3) or a taper from an attached end (146a) to a free end (146b).
13. The implant as claimed in claim 7, wherein the block (180) includes a first side (182c) and a second side (182d) configured to slide within the cavity (122) of the slot (120) of the plate (110).
14. The implant as claimed in claim 7, wherein the block (180) includes a top surface (182a) having a curvature to restrict the movement of the block (180) within the slot (120).
15. The implant as claimed in claim 7, wherein the first adjustable fixture element and the second adjustable fixture element are made of one or more biocompatible materials.