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:
ALIGNMENT GUIDE
2. APPLICANT:
Meril Corporation (I) Private Limited, an Indian company of the address Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-396191 Gujarat, India.

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

FIELD OF INVENTION
[001] The present disclosure relates to an alignment guide. More particularly, the present disclosure relates to an alignment guide used to ensure precise positioning and alignment of an implant, a bone, or an instrument and mechanism thereof.
BACKGROUND OF THE INVENTION
[002] Total knee arthroplasty (TKA), commonly referred to as total knee replacement, is a prevalent orthopedic surgery aimed at replacing a damaged or diseased knee joint with a prosthetic implant. Before performing a TKA, the surgeon selects an appropriate type of knee prosthesis (or prosthesis) tailored to meet a patient's specific needs and anatomy. Each of the prosthesis includes at least one of a femoral component, a tibial component, and/or a tibial liner.
[003] This selection process is crucial as different categories of prostheses are available to address various patient conditions and/or anatomies. Prior to implanting the chosen prosthesis, the surgeon meticulously resects one or more portions of the patient’s tibia and/or femur using a bone saw or the like, reshaping these bones to ensure a proper fit for the prosthetic components. Prior to using the bone saw, a jig is positioned on an outer surface of the bone to be resected. The jig is used to pre-plan the movement of the bone saw according to the bone anatomy and shape of the prosthesis. This preparation is essential for achieving optimal alignment, stability, and function of the knee post-surgery.
[004] It is essential that the jig is positioned on the outer surface of the bone with accurate axial and angular alignment. However, conventionally available tool to verify the axial and angular alignment of the jig prior to using the bone saw are very difficult to use leading to improper bone resections and implant misalignment. This misalignment can lead to poor patellar tracking, where the kneecap does not move smoothly along the femoral component, resulting in pain and reduced mobility for the patient. Additionally, incorrect alignment can cause joint instability, leading to a feeling of the knee giving way and increasing the risk of falls or further injury. Another potential problem is uneven wear of the prosthetic components due to misalignment, which can significantly reduce the lifespan of the prosthesis and necessitate early revision surgery.
[005] Thus, there arises a need for an instrument that overcomes the aforesaid problems associated with deformity correction surgeries, fracture fixation and joint replacements.
SUMMARY OF INVENTION
[006] 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.
[007] The present disclosure relates to an alignment guide including a body, a leg, and a ridge. The body having a proximal portion and a distal portion. The distal portion of the body defines a substantially axially extending face. The body defines a bracket disposed distal to the face. The leg is disposed adjacent to the face extending from a central portion of the body to the distal portion of the body. The leg is provided with a first segment, a second segment, a third segment and a holder. The first segment is configured to receive a pushing force and move laterally inwards towards the face. The third segment is disposed distal to the first segment. The third segment is configured to move laterally outward and away from the bracket in response to the lateral inward movement of the first segment. The second segment is disposed between the first segment and the third segment. The holder extends away from the third segment, towards the bracket of the body. The ridge couples the leg to the face of the body. The bracket, the third segment of the leg and the holder are configured to be removably coupled to a jig. The leg is configured to toggle from a normal position to a flexed position in response to a pushing force received by the first segment of the leg. The leg is configured to self-toggle back to the normal position after the pushing force is removed.
BRIEF DESCRIPTION OF DRAWINGS
[008] 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.
[009] Fig. 1 depicts an alignment guide 100, in accordance with an embodiment of the present disclosure.
[0010] Fig. 1a depicts a leg 103 of the alignment guide 100, in accordance with an embodiment of the present disclosure.
[0011] Fig. 1b depicts the alignment guide 100 in its flexed position, in accordance with an embodiment of the present disclosure.
[0012] Fig. 2a depicts a first perspective view of an assembly of the alignment guide 100, a jig 200, and an EM tower 210, in accordance with an embodiment of the present disclosure.
[0013] Fig. 2b depicts an enlarged cross-sectional view of the assembly of Fig. 2, in accordance with an embodiment of the present disclosure.
[0014] Fig. 3 depicts an exemplary method 300 to use the alignment guide 100, in accordance to an exemplary embodiment of the present disclosure.
[0015] Fig. 3a depicts a second perspective view of the assembly depicted in Fig. 2a coupled to an alignment rod 230, and a bone 10, in accordance with an embodiment of the present disclosure.
[0016] Fig. 4 depicts a side view of the assembly depicted in Fig. 3a, in accordance with an embodiment of the present disclosure.
[0017] Fig. 4a depicts a proximal view of the assembly depicted in Fig. 3a, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[0018] 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.
[0019] 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.
[0020] 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.
[0021] 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.
[0022] The present disclosure relates to an instrument specifically engineered to ensure precision in the positioning and alignment of two or more of implants, bones, or instruments during various medical procedures. This instrument plays a crucial role in aiding a medical practitioner (for example, a surgeon) to achieve accurate anatomical alignment, which is imperative for successful outcome of a surgery such as a joint replacement surgery, a fracture fixation, and/or a deformity correction. This instrument can also be called as an alignment guide. By providing essential cues and reference points, the alignment guide significantly enhances the accuracy of surgical interventions, thereby improving overall patient outcomes, minimizing the errors and enhances recovery times.
[0023] The alignment guide of the present disclosure can be removably coupled to a jig used for planning a bone resection prior to seating an implant (or components thereof) on the bone. An alignment rod is provided with the alignment guide which corresponds to the required angular and axial alignment of a longitudinal axis of the jig with a longitudinal axis of the bone. The axial alignment corresponds to the alignment rod and the longitudinal axis of the bone being co-planar along the length of the alignment rod. The angular alignment corresponds to a resection angle (for example, as decided by the medical practitioner/selected jig) between the alignment rod and the longitudinal axis of the bone. The alignment guide ensures accurate axial and angular alignment of the jig as described above by maintaining the resection angle between the alignment rod and the jig (or the longitudinal axis thereof).
[0024] After ensuring the jig is accurately aligned and positioned over an outer surface of the bone, the alignment guide (along with the alignment rod) is easily decoupled from the aligned jig. The decoupling (and coupling) mechanism of the alignment guide of the present disclosure is very easy to use (and manufacture). After decoupling the alignment guide form the aligned jig, the bone is resected using a bone saw (or the like) through the aligned jig and the implant is seated.
[0025] In an embodiment of the present disclosure, as depicted in Fig. 1, the alignment guide 100 includes an elongated body (or body) 110 having a proximal end 100A and a distal end 100B. The proximal end 100A and distal end 100B define the length of the body 110. The average distance between the proximal end 100A and distal end 100B ranges from 1 mm to 2000 mm. In an exemplary embodiment, the length of the body 110 is 1500 mm. The alignment guide 100 is made of one or more materials including but not limited to, stainless steel, titanium, cobalt chromium (CoCr), etc. The alignment guide 100 may be assembled or be carved out of a single bloc of material thereby having an integral structure. In an exemplary embodiment, the alignment guide 100 is carved out of a single block of precipitation-hardening stainless steel. In an exemplary embodiment, the thickness of the alignment guide 100 may vary throughout the length of the alignment guide 100. The variation in thickness of the alignment guide 100 may either be continuous and uniform or stepped depending upon the user preference and/or the components with which the alignment guide 100 is coupled to. Alternately, the thickness of the alignment guide 100 may be uniform.
[0026] In an embodiment of the present disclosure as depicted in Fig. 1, the portion or area of the body 110 at the proximal end 100A is referred as the “proximal portion”. The proximal portion includes for example, a circular end. The depicted circular end of the proximal portion is exemplary, and other geometrical shapes are within the teachings of the present disclosure.
[0027] The proximal portion includes at least one hole 101, of a diameter for example, 0.5 mm minimum each. In the depicted embodiment, two holes 101 are provided in the proximal portion. One hole 101 of the proximal portion may be situated at a distance of 0.5 mm to 500 mm from the proximal end 100A. The holes 101 may be located 0.5 mm to 500 mm away from each other. The two holes 101 may lie along the central longitudinal axis of the alignment guide 100. The holes 101 are typically designed to hold respective components at a pre-defined angle. For example, the component may be an alignment rod 230 (as shown in Fig. 3a) to be held perpendicular to the alignment guide 100. It is possible that only one hole 101 may be used during the surgery by a surgeon, at his/her discretion.
[0028] Further, one or more elongated apertures 101a may be present in between the two holes 101. The elongated aperture 101a may contribute to aesthetics of the alignment guide 100 and/or provide separation between the two holes 101.
[0029] In an embodiment of the present disclosure, as depicted in Fig.1, the sides of the proximal portion have a ridged texture. The role of the textured sides having ridge(s) is mainly to assist a medical practitioner to securely grasp the alignment guide 100 during the surgery.
[0030] In an embodiment of the present disclosure, the other end of the alignment guide 100 located opposite to the proximal end 100A, is the distal end 100B. The portion or area of the body 110 present near the distal end 100B is referred as the “distal portion”. The distal portion includes at least one leg 103 operatively coupled to the body 110 via a ridge 105. The ridge 105 functions as a fulcrum/pivot point for the leg 103 to be flexed with respect to the body 110. Accordingly, the leg 103 is configured to be toggled between a flexed position (as shown in Fig. 1b) and a normal position (as shown in Fig. 1). The medical practitioner may apply a pressing/pushing force on at least a portion of the leg 103 to toggle the leg 103 from its normal position to its flexed position. Upon removing the pushing force from the leg 103, the leg 103 is configured to self-toggle back to its normal position.
[0031] As shown in Fig. 1, the leg 103 is an elongated bar-like structure that extends along an edge of the alignment guide 100 from a nearly central portion of the alignment guide 100 till the distal end 100B of the alignment guide 100. At least a portion of the leg 103 is disposed towards an inner face (or face) 113 of the body 110. The two are shaped at least partially complementing each other. The leg 103 is spaced away from the face 113 of the body (110) thereby creating a gap. The gap provides room for the leg 103 to flex/pivot with respect to the body 110. The face 113 is provided with at least a first projection 113a and a second projection 113b to at least partially control the flex of the leg 103 with respect to the body 110. The face 113 extends substantially axially between the first projection 113a and the second projection 113b, as shown in Fig. 1.
[0032] The leg 103 may be a hollow or a solid structure. As shown in Fig. 1a, the leg 103 is made of multiple segments such as a stopper 103a, a grip 103b, a clip 103c and a holder 103d. Although the leg 103 of the present disclosure is described with example of both the stopper 103a and the clip 103c, the leg 103 may have either of the stopper 103a or the clip 103c. The leg 103 may be an integral structure or the multiple segments can be coupled as appropriate. The properties and functionalities of each segment is described below. The multiple segments of the leg 103 may either have different thicknesses or have uniform thickness.
[0033] With respect to the segments of the leg 103, the distal portion of the alignment guide 100 (i.e., the leg 103 as well as the body 110) is divided in three segments: a first segment extending between the stopper 103a and the ridge 105, a second segment extending between the ridge 105 and the clip 103c, and a third segment extending between the clip 103c and the holder 103d (and the distal end 100B). In the normal position of the leg 103 (as shown in Fig. 1), the first segment, the second segment and the third segment are substantially aligned with the edge of the body 110 of the alignment guide 100. In the flexed position of the leg 103 (as shown in Fig. 1b), the first segment is at least partially flexed inwards, towards the face 113. And, the second segment and the third segment are at least partially flexed outwards, away from the face 113.
[0034] In an embodiment of the present disclosure, the first segment of the body 110 (and the leg 103) starts from nearly the center of the alignment guide 100 and extends till the ridge 105. It includes the ridge 105, the stopper 103a, the grip 103b, and the first projection 113a of the alignment guide 100. In the depicted embodiment of the alignment guide 100 as shown in Fig. 1, the first projection 113a is disposed at the edge of the body 110, extending axially towards the leg 103. In the normal position of the leg 103, at least a portion of the first segment of the leg 103 aligns with the first projection 113a. In an exemplary embodiment, in the normal position of the leg 103 as shown in Fig. 1, the entire leg 103 aligns with the first projection 113a of the body 110 except the stopper 103a of the leg 103.
[0035] The ridge 105 is provided between the grip 103b and the clip 103c of the leg 103. The ridge 105 acts as a pivot point (or fulcrum) for the leg 103 against the face 113 of the body 110. The ridge 105 provides the leg 103, a flexibility/resiliency to move and perform its function, without damaging the alignment guide 100. As an exemplary embodiment, the ridge 105 is a lateral elongated structure that connects the leg 103, and the body 110. The resiliency of the ridge 105 may depend on the width of the ridge 105. The width of the ridge 105 ranges from 0.5 mm to 20 mm. In an exemplary embodiment, the width of the ridge 105 is 2 mm. The resiliency of the ridge 105 provides a bias to the leg 103 to be in its normal position, thereby allowing the leg 103 to self-toggle to its normal position from its flexed position.
[0036] In an embodiment, as shown in Fig. 1, the edges of the ridge 105 are at least partially surrounded with one or more empty spaces. The empty space provides room for the ridge 105 to flex when the leg 103 is toggled from its normal position to its flexed position and vice versa. The empty space around the ridge 105 may range from 0.5 mm to 100 mm depending upon the flex required and/or the width of the ridge 105.
[0037] The stopper 103a is the proximal most segment of the leg 103. The stopper 103a is coupled in an offset manner to the grip 103b of the leg 103 such that the stopper 103a is disposed between the first projection 113a and the face 113 of the body 110. The stopper 103a is configured to move laterally within a gap created between the face 113 of the body 110 and the first projection 113a of the body 110. The stopper 103a at least partially controls the movement of the holder 103d (and the third segment of the leg 103) when the leg 103 is toggled from the normal position to its flexed position. For instance, controlling the movement of the holder 103d includes limiting a laterally outward movement of the holder 103d (and the third segment of the leg 103). In the normal position of the leg 103 (as shown in Fig. 1), the stopper 103a is disposed between the first projection 113a and the face 113. In the flexed position of the leg 103 (as shown in Fig. 1b), the stopper 103a at least partially abuts the face 113 of the body 110. The stopper 103a can move for a distance ranging between 0.5 mm to 100 mm, preferably 2 mm. The distance may depend upon the force applied by the medical practitioner on at least a portion of the leg 103 and/or the distance between the first projection 113a and the face 113 of the body 110 of the alignment guide 100.
[0038] The grip 103b includes two ends, a first end coupled to the stopper 103a located away from the distal end 100B and a second end merged with the ridge 105. As shown in Fig. 1, the grip 103b is disposed proximal to the first projection 113a. The grip 103b may have a length ranging from 1 mm to 500 mm. In an exemplary embodiment, the length of the grip 103b is 30 mm. Optionally, at least a portion of the outer surface of the grip 103b is provided with ridges or the like for improved contact for a surgeon.
[0039] In the normal position of the leg 103 (as shown in Fig. 1), the grip 103b is at least partially aligned with the first projection 113a. In the flexed position of the leg 103 (as shown in Fig. 1b), at least a portion of the grip 103b is flexed inwards, towards the face 113 against the bias of the ridge 105.
[0040] In an embodiment of the present disclosure, the second segment of the body 110 (and the leg 103) starts from the ridge 105 and extends till the clip 103c. The second segment is disposed between the first segment and the third segment of the body 110. It includes the clip 103c, and the second projection 113b of the alignment guide 100. The second projection 113b is disposed operationally with respect to the clip 103c of the leg 103.
[0041] In an exemplary embodiment, as shown in Figs 1 and 1a, the clip 103c includes a substantially L-shaped structure extending laterally towards the face 113 and away from the leg 103. The clip 103c at least partially encloses the second projection 113b such that an end portion of the clip 103c is disposed between the second projection 113b and the face 113 of the body 110. The clip 103c at least partially controls the movement of the holder 103d (and the third segment of the leg 103) when the leg 103 is toggled from the normal position to its flexed position. For instance, controlling the movement of the holder 103d includes limiting the laterally outward movement of the holder 103d (and the third segment of the leg 103). In the normal position of the leg 103 (as shown in Fig. 1), the end portion of the clip 103c is disposed between the second projection 113b and the face 113 of body 110. In the flexed position of the leg 103 (as shown in Fig. 1b), the end portion of the clip 103c at least partially abuts the second projection 113b.
[0042] In an embodiment of the present disclosure, the third segment of the body 110 (and the leg 103) starts from the clip 103c and extends till the holder 103d. In an exemplary embodiment, as shown in Fig. 1, the third segment of the alignment guide 100 gradually tapers distally close to the clip 103c of the leg 103. It includes the holder 103d, and a bracket 115 of the body 110.
[0043] The bracket 115 is disposed at the distal end 100B of the body 110. The bracket 115 is shaped basis the shape of a coupling member 201 of the jig 200 (as shown in Fig. 2b) to which the alignment guide 100 is removably coupled. In an exemplary embodiment, as shown in Fig. 1, the bracket 115 is L-shaped.
[0044] Fig. 2a depicts an exemplary assembly of the alignment guide 100 coupled to the jig 200. And, Fig. 2b depicts a cross-sectional view of the alignment guide 100 and the jig 200 depicting the coupling therebetween. As shown in Fig. 2b, the jig 200 is provided with the coupling member 201 configured to removably receive the alignment guide 100. The coupling member 201 is disposed within a slit 203 of the jig 200, as shown in Fig 2a. An EM tower 210 is coupled to the jig 200 thereby defining a pre-defined angle at which the bone is resected with a bone saw or the like. Thus, the EM tower 210 dictates the angular alignment of the jig 200 with the bone.
[0045] As shown in Fig. 2b, the coupling member 201 of the jig 200 is removably received between the bracket 115 and a portion of the third segment of the leg 103. In an embodiment, the thickness of the third segment is minimum compared to the entire alignment guide 100, thereby allowing the medical practitioner to at least partially insert the third segment of the alignment guide 100 within the slit 203 of jig 200. Accordingly, the thickness of the third segment may vary based on the shape and size of the slit 203 of the jig 200 used along with the alignment guide 100.
[0046] The holder 103d is the distal most segment of the leg 103 and is disposed at the distal end 100B of the alignment guide 100. The holder 103d is configured to at least partially interact with a jig 200 (as shown in Figs. 2a and 2b). The holder 103d at least partially extends laterally inwards from the third segment towards the bracket 115. The holder 103d may have a length ranging from 0.5 mm to 500 mm. In an exemplary embodiment, the length of the holder 103d is 30 mm. In the normal position of the leg 103, as shown in Fig. 2b, the holder 103d helps to securely capture the coupling member 201 of the jig 200 between the bracket 115 and the third segment of the leg 103 thereby coupling the alignment guide 100 to the jig 200. The coupling member 201 of the jig 200 should fit in between the bracket 115, the third segment of the leg 103, and the holder 103d, like the puzzle ends fit together.
[0047] In an embodiment of the present disclosure, the combined structure defined by the bracket 115 and the third segment of the leg 103 is rectangular-like, with difference in the dimensions thereof. However, the structure may vary in line with the structure of the coupling member 201 of the jig 200.
[0048] In one of the embodiments, as shown in Fig. 3, the present disclosure describes a method 300 of using the alignment guide 100 to accurately align the jig 200 on an outer surface of a bone 10 (as shown in Fig. 3a). The method 300 commences at step 301 by toggling the leg 103 of the alignment guide 100 from its normal position to its flexed position. A (pushing/pressing) force is applied say, by a medical practitioner, to the first segment of the leg 103 (or the grip 103b) causing it to move laterally inwards (or towards the face 113). The lateral inward movement of the first segment of the leg 103 (or the grip 103b) is limited by the stopper 103a as it at least partially abuts the face 113 of the body 110.
[0049] Simultaneously, with the lateral inward movement of the first segment of the leg 103, the pushing force received by the first segment causes a lateral outward movement of the second and third segment of the leg 103 due to the ridge 105. The lateral outward movement of the second and third segment is limited by the clip 103c as it at least partially abuts the second projection 113b. The lateral outward movement of the third segment of the leg 103 causes the holder 103d to move laterally away from the bracket 115 thereby, toggling the leg 103 of the alignment guide 100 to the flexed position.
[0050] At step 303, the alignment guide 100 is advanced within the slit 203 of the jig 200 to at least partially abut the bracket 115 of the alignment guide 100 against the coupling member 201 of the jig 200.
[0051] At step 305, the pushing force applied on the first segment of the leg 103 is removed causing the leg 103 to self-toggle to the normal position from the flexed position. While the leg 103 is self-toggled to its normal position, the holder 103d of the leg 103 moves laterally towards the bracket 115 thereby, capturing the coupling member 201 of the jig 200 between the holder 103d, the third segment of the leg 103 and the bracket 115. At the end of step 305, the alignment guide 100 is removably coupled to the jig 200 (as shown in Fig. 2a and 2b).
[0052] At step 307, the alignment rod 230 is inserted in at least one of the holes 101 of the alignment guide 100 (as shown in Fig. 3a). The holes 101 ensures that the alignment rod 230 is perpendicular to the alignment guide 100. Because of the coupling between the alignment guide 100 and the jig 200, the EM tower 210 makes a resection angle (corresponding to the angle at which the bone 10 is to be resected) with the alignment rod 230. In other words, as shown in Fig. 4, a longitudinal axis ‘x’ defined by the alignment rod 230 defines the resection angle with a longitudinal axis ‘z’ of the jig 200 (and the EM tower 210).
[0053] At step 309, the medical practitioner positions the assembly of the alignment guide 100, the jig 200, the EM tower 210 and the alignment rod 230 over an outer surface of a bone 10 (as shown in Fig. 3a) and ensures that a longitudinal axis ‘x’ defined by the alignment rod 230 is axially and angularly aligned with a longitudinal axis ‘y’ of the bone 10 (as shown in Fig. 4). Since the alignment rod 230 defines the resection angle with the EM tower 210 due to the alignment guide 100, a longitudinal axis ‘z’ of the jig 200 (and the EM tower 210) and the longitudinal axis ‘y’ of the bone 10 is said to be angularly aligned for accurate resection at the resection angle (as shown in Fig. 4).
[0054] In the depicted embodiment, as shown in Fig. 4, the jig 200 used with the alignment guide 100 is for resecting the bone 10 at 7 degrees (i.e., the resection angle). Accordingly, the jig 200, and the EM tower 210 makes an angle of 7 degrees with the alignment rod 230. And, the alignment rod 230 makes an angle of 7 degrees with the bone 10 thereby, accurately aligning the jig 200 for resecting the bone 10 at 7 degrees.
[0055] Although the method 210 is described with the example of a jig 200 used to resect at 7 degrees, resecting the bone 10 at other resection angles with respective jigs 200 are within the scope of the teachings of the present disclosure.
[0056] With respect to the axial alignment, the longitudinal axis ‘x’, ‘y’ and ‘z’ are ensured to be co-planar to each other as shown in Fig. 4a. At the end of the step 311, it is ensured by the medical practitioner with the help of the alignment guide 100 and the alignment rod 230 that the jig 200 and the EM tower 210 is angularly and axially aligned with the bone 10.
[0057] At step 311, the aligned jig 200 is coupled to the bone 10 via, for example, pins (not shown) to fix the position of the jig 200 on an outer surface of the bone 10.
[0058] At step 313, the alignment guide 100 (along with the alignment rod 230) is decoupled from the coupling member 201 of the jig 200 (and the EM tower 210). Similar to step 301, a pressing/pushing force is applied on the first segment of the leg 103 to cause the holder 103d to laterally move away from the bracket 115. Moving the holder 103d away from the bracket 115 causes the leg 103 of the alignment guide 100 to toggle to its flexed position from its normal position. The alignment guide 100, in the flexed position of the leg 103, is pulled away from the slit 203 of the jig 200.
[0059] At step 315, a bone saw (not shown) or the like is used with the jig 200 to resect the bone 10 and an implant (not shown) is seated on the bone 10.
[0060] 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 alignment guide (100), comprising:
a. a body (110) having a proximal portion and a distal portion, the distal portion of the body (110) defining a substantially axially extending face (113), the body (110) defining a bracket (115) disposed distal to the face (113);
b. a leg (103) disposed adjacent to the face (113) extending from a central portion of the body (110) to the distal portion of the body (110), the leg (103) being provided with:
i. a first segment configured to receive a pushing force and move laterally inwards towards the face (113),
ii. a third segment being disposed distal to the first segment, the third segment configured to move laterally outward and away from the bracket (115) in response to the lateral inward movement of the first segment,
iii. a second segment being disposed between the first segment and the third segment, and
iv. a holder (103d) extending away from the third segment, towards the bracket (115) of the body (110); and
c. a ridge (105) coupling the leg (103) to the face (113) of the body (110);
wherein, the bracket (115), the third segment of the leg (103) and the holder (103d) are configured to be removably coupled to a jig (200);
wherein, the leg (103) is configured to toggle from a normal position to a flexed position in response to a pushing force received by the first segment of the leg (103); and
wherein, the leg (103) is configured to self-toggle back to the normal position after the pushing force is removed.
2. The alignment guide (100) as claimed in claim 1, wherein in the flexed position of the leg (103):
a. the first segment is at least partially inwards, towards the face (113), and
b. the second segment and the third segment are at least partially flexed outwards, away from the face (113).
3. The alignment guide (100) as claimed in claim 1, wherein in the normal position of the leg (103) the first segment, the second segment and the third segment are substantially aligned with an edge of the body (110) of the alignment guide (100).
4. The alignment guide (100) as claimed in claim 1, wherein the leg (103) is spaced away from the face (113) of the body (110) thereby creating a gap.
5. The alignment guide (100) as claimed in claim 1, wherein a proximal portion of the body (110) includes at least one hole (101) configured to hold an alignment rod (230).
6. The alignment guide (100) as claimed in claim 1, wherein the face (113) extends between a first projection (113a) and a second projection (113b).
7. The alignment guide (100) as claimed in claim 1, wherein the leg (103) includes at least one of a stopper (103a) and a clip (103c) to at least partially control the lateral outward movement of the third segment of the leg (103).
8. The alignment guide (100) as claimed in claim 1, wherein the leg (103) includes a stopper (103a) disposed between the face (113) and a first projection (113a) of the body (110).
9. The alignment guide (100) as claimed in claim 1, wherein the leg (103) includes a clip (103c) at least partially enclosing the second projection (113b) of the body (110), thereby being disposed at least partially between the second projection (113b) of the body (110) and the face (113).
10. The alignment guide (100) as claimed in claim 1, wherein the leg (103) includes a clip (103c) having a substantially L-shaped structure and extending laterally towards the face (113) and away from the leg (103).
11. The alignment guide (100) as claimed in claim 1, wherein the ridge (105) includes a width ranging from 0.5 mm to 20 mm.
12. The alignment guide (100) as claimed in claim 1, wherein the ridge (105) includes edges at least partially surrounded with one or more empty spaces.
13. The alignment guide (100) as claimed in claim 1, wherein the bracket (115), the third segment of the leg (103) and the holder (103d) are configured to be removably coupled to a coupling member (201) of the jig (200) through a slit (203) of the jig (200).
14. The alignment guide (100) as claimed in claim 1, wherein the thickness of the third segment is minimum compared to the entire alignment guide (100).
15. An assembly comprising:
a. an alignment guide (100) as claimed in any of the preceding claims 1 - 14,
b. a jig (200) removably coupled to the alignment guide (100), a coupling member (201) of the jig (200) is removably coupled to a bracket (115), a third segment of a leg (103) and a holder (103d) of the alignment guide (100);
c. an EM tower (210) coupled to the jig (200) and defining a longitudinal axis ‘y’ along with the jig (200);
d. at least one alignment rod (230) disposed within at least one hole (101) of the alignment guide (100) and defining a longitudinal axis ‘x’;
wherein, the alignment guide (100) is configured to maintain a resection angle between the longitudinal axis ‘z’ of the EM tower (210) and the longitudinal axis ‘x’ of an alignment rod (230).