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:
DEVICE FOR INSERTING AN ORTHOPEDIC IMPLANT

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

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


FIELD OF INVENTION
[1] The present disclosure relates to a bio-medical device. More particularly, the present disclosure relates to a device for inserting an orthopedic implant.
BACKGROUND OF INVENTION
[2] Hip replacement surgeries or hip arthroplasty surgeries are procedures which involves the replacement of the damaged human hip with the artificial femoral prosthesis implant. A hip replacement surgery is needed to an individual whose hip joint has been damaged due to conditions such as factures, arthritis, osteointegration.
[3] A typical hip replacement system includes four major components, namely, modular shell, modular liner, femoral head and femoral stem. The modular shell and the modular liner form the acetabulum part of the hip joint, whereas the femoral head and the femoral stem forms the femoral part of the hip joint. Femoral stems are available in various sizes and shapes to serve needs of patients/patient populations having different anatomies and requirements.
[4] During the hip replacement surgery, a femoral stem is inserted inside the medullary canal of a patient. Typically, a surgeon uses an instrument, called a stem insertion device to facilitate the insertion of the femoral stem implant into the medullary canal of the patient.
[5] Various devices have been designed to facilitate insertion of the stem inside the femur. However, conventionally, a separate insertion device is needed for each size and shape of the femoral stem. This increases the cost for the healthcare professionals, which also increases the patient’s medical cost. Further, the conventional devices also lack precision, which results in an incorrect positioning and misalignment of the femoral stem during the insertion procedure. This leads to further complications such as pain and damage to the tissues of the targeted area.
[6] Thus, there arises a need for a device that overcomes the problems associated with the conventional devices.
SUMMARY OF INVENTION
[7] The present disclosure relates to a device for inserting an orthopedic implant. In an embodiment, the device includes a connecting element, a shaft, and a holder. The connecting element includes a distal tip configured to engage with a body portion of an orthopedic implant. The shaft is coupled to the connecting element and includes a cavity extending at least partially along the length of the shaft. The cavity is configured to accommodate a portion of the connecting element. The shaft further includes a pair of grooves.
[8] The holder is adjustably coupled to the shaft at a plurality of transverse positions. The holder includes a first portion provided at a first end and including a first arm and a second arm. The first arm and the second arm define an opening therebetween. The opening is configured to receive a grooved portion of the shaft. The second portion of the holder extends from the first portion to a second end of the holder at a predefined angle. The second portion is configured to engage with a neck portion of the orthopedic implant. The first arm and the second arm are slidable within the respective grooves of the shaft. The first arm and the second arm are slid to set the holder at a desired transverse position among the plurality of transverse positions based on at least one of: a type or size of the orthopedic implant.
[9] The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF DRAWINGS
[10] 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.
[11] Fig. 1A depicts an assembled view of a device 100, according to an embodiment of the present disclosure.
[12] Fig. 1B depicts a cross-sectional view of the device 100, according to an embodiment of the present disclosure.
[13] Fig. 1C depicts a front view of a distal portion of the device 100, according to an embodiment of the present disclosure.
[14] Fig. 1D depicts a back view of the distal portion of the device 100, according to an embodiment of the present disclosure.
[15] Fig. 1E depicts a perspective view of the distal portion of the device 100, according to an embodiment of the present disclosure.
[16] Fig. 1F depicts a cross-sectional view of a distal portion of the device 100, according to an embodiment of the present disclosure.
[17] Fig. 2A depicts a connecting element 110 of the device 100, according to an embodiment of the present disclosure.
[18] Fig. 2B depicts a distal portion of the connecting element 110 of the device 100, according to an embodiment of the present disclosure.
[19] Fig. 3A depicts a shaft 120 of the device 100, according to an embodiment of the present disclosure.
[20] Fig. 3B depicts a front view of the shaft 120 of the device 100, according to an embodiment of the present disclosure.
[21] Fig. 3C depicts a side view of the shaft 120 of the device 100, according to an embodiment of the present disclosure.
[22] Fig. 3D depicts a cross-sectional view of the shaft 120 of the device 100, according to an embodiment of the present disclosure.
[23] Fig. 4 depicts a knob 130 of the device 100, according to an embodiment of the present disclosure.
[24] Fig. 5 depicts a holder 140 of the device 100, according to an embodiment of the present disclosure.
[25] Fig. 6 depicts a cap 150 of the device 100, according to an embodiment of the present disclosure.
[26] Fig. 7 depicts a restraining member 190 of the device 100, according to an embodiment of the present disclosure.
[27] Fig. 8 depicts a locking member 160 of the device 100, according to an embodiment of the present disclosure.
[28] Fig. 9 depicts a flange 180 of the device 100, according to an embodiment of the present disclosure.
[29] Fig. 10 depicts a coupling of a femoral stem 200 with the device 100, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[30] 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.
[31] 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.
[32] 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.
[33] 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.
[34] The present disclosure relates to a device for inserting an orthopedic implant, such as a femoral stem. The device is designed to facilitate optimal performance and a precise insertion of the orthopedic implant. For example, the device is used to insert a femoral stem (e.g., a cemented femoral stem) into a patient’s medullary canal during a hip replacement surgery. The device includes an assembly that can be adjusted so that the device can be coupled to orthopedic implants (e.g., femoral stems) of different sizes. Thus, the device of the present disclosure is compatible with a wide variety of orthopedic implants. For example, the same device can be used for multiple sizes of femoral stems (e.g., different sizes of narrow and standard femoral stems). This enhances the usability of the propose device and reduces medical costs of the implantation procedure. Though the present disclosure has been described in context of a femoral stem, the teachings of the present invention extend to inserting other orthopedic implants such as a humeral stem and the same is within the scope of the present disclosure.
[35] Fig. 1A depicts an assembled view of a device 100 for inserting an orthopedic implant and Fig. 1B depicts a cross-sectional view of the device 100, according to an embodiment. Figs. 1C – 1F depict various views of a distal portion of the device 100. The device 100 has a proximal end 100a and a distal end 100b. In an embodiment, the device 100 includes a connecting element 110, a shaft 120, a knob 130, a holder 140, a cap 150, a locking member 160, a resilient member 170 (shown in Fig. 1F), a flange 180, and a restraining member 190. The device 100 disclosed in the present disclosure facilitates a controlled and precise insertion of the orthopedic implant, e.g., a femoral stem into the medullary canal of a patient. The device 100 is adjustable to couple with femoral stems of various sizes and shapes. So, the same device 100 can be used for femoral stems of multiple types and sizes. For example, as per an embodiment of the present disclosure, the device 100 can be used to insert a narrow femoral stem of various sizes and/or a standard femoral stem of various sizes.
[36] Fig. 2A depicts the connecting element 110, according to an embodiment. Fig. 2B depicts a distal portion of the connecting element 110. The connecting element 110 is coupled with a femoral stem during the implantation procedure. The connecting element 110 has a proximal end 110a and a distal end 110b. The connecting element 110 may have a shape such as without limitation, rectangular, cylindrical, etc. In an embodiment, the connecting element 110 is cylindrical. The connecting element 110 may have a solid or a hollow core. The hollow core reduces the overall weight of the connecting element 110. The connecting element 110 may be made of a suitable material, e.g., any medical grade stainless steel. In an embodiment, the connecting element 110 is made of 17-4 PH stainless steel. An extension 110c may be provided at the proximal end 110a of the connecting element 110. In an embodiment, the extension 110c is coupled with the knob 130. In an embodiment, the extension 110c is provided with a hole 110c1 extending throughout the width of the extension 110c. The hole 110c1 is used to couple the connecting element 110 with the knob 130 (described later). The hole 110c1 may have a pre-defined shape such as, without limitation, oval, rectangular, circular, etc. In an embodiment, the hole 110c1 is circular in shape.
[37] The distal end 110b of the connecting element 110 may have a tapered profile such that the diameter of the connecting element 110 gradually reduces towards the distal end 110b. The tapered profile of the distal end 110b of the connecting element 110 helps in reducing the stress. A distal tip 110d is provided at the distal end 110b of the connecting element 110. The distal tip 110d may have a pre-defined shape such as, without limitation, dome, spherical, conical, cylindrical, etc. In an embodiment, the distal tip 110d is dome shaped. The distal tip 110d is configured to engage with a body portion of the orthopedic implant. For example, the distal tip 110d engages with a corresponding aperture of a body portion of the femoral stem during a medical procedure to couple the device 100 with the femoral stem. The distal tip 110d may be coupled to the aperture of the femoral stem via a technique such as without limitation, snap-fit, press-fit, etc. In an embodiment, the distal tip 110d is coupled to the aperture of the femoral stem via a clearance fit mechanism.
[38] The connecting element 110 includes a threaded portion 110e. In an embodiment, the threaded portion 110e is located towards the distal end 110b of the connecting element 110. The threaded portion 110e is provided with outer threads 110e1 on the outer surface of the connecting element 110. The outer threads 110e1 extend for a partial length of the connecting element 110. The outer threads 110e1 are used to couple the connecting element 110 with the shaft 120 (described later). The outer threads 110e1 facilitate the longitudinal movement of the connecting element 110 within the shaft 120.
[39] Figs. 3A-3D illustrate an exemplary shaft 120, according to an embodiment. The shaft 120 has a proximal end 120a and a distal end 120b. The shaft 120 enables a user to hold the device 100. In an embodiment, the shaft 120 has a hollow, tubular structure. The shaft 120 may have a pre-defined cross-section such as circular, rectangular, etc. In an embodiment, the shaft 120 is generally cylindrical with flat surfaces 120g extending longitudinally on opposite sides. The flat surfaces 120g allow the locking member 160 to slide over the shaft 120 while preventing the locking member 160 from rotating with respect to the shaft 120. The shaft 120 may be made of a suitable material, e.g., any medical grade stainless steel. In an embodiment, the shaft 120 is made of 17-4 PH stainless steel.
[40] In an embodiment, the shaft 120 acts as a housing to the connecting element 110. The shaft 120 has a cavity 120e. The cavity 120e extends at least partially along the length of the shaft 120. In an embodiment, the cavity 120e extends along the entire the length of the shaft 120. The cavity 120e accommodates at least a portion of the connecting element 110 as depicted in Fig. 1B. The shaft 120 includes a proximal portion 120c provided at the proximal end 120a of the shaft 120 and a distal portion 120h extending distally from the proximal portion 120c to the distal end 120b of the shaft 120. The flat surfaces 120g are provided on the opposite sides of distal portion 120h. The proximal portion 120c is coupled with the flange 180. The distal portion 120h includes a threaded portion 120i provided within the cavity 120e. In an embodiment, the threaded portion 120i is located towards the distal end 120b of the shaft 120 (more clearly shown in Fig. 3E). The threaded portion 120i is provided with inner threads 120i1 on the inner surface of the shaft 120. The inner threads 120i1 of the shaft 120 are complementary to the outer threads 110e1 of the connecting element 110. The inner threads 120i1 of the shaft 120 are configured to engage with the outer threads 110e1 of the connecting element 110. The threaded engagement between the connecting element 110 and the shaft 120 facilitates longitudinal motion of the connecting element 110. The shaft 120 includes a pair of grooves 120d on the distal portion 120h disposed towards the distal end 120b of the shaft 120. The pair of grooves 120d are located diametrically opposite to each other, and defined a grooved portion 120d1 of the shaft 120. The pair of grooves 120d extended between the flat surfaces 120g of the shaft 120. In an embodiment, the pair of grooves 120d are coupled to the holder 140. The pair of grooves 120d are configured to receive a portion of the holder 140 (described later). The shaft 120 has a ridge 120f provided proximal to the pair of grooves 120d at a pre-defined distance. The ridge 120f is annular. The ridge 120f acts as a stopper for the locking member 160 during the operation of the device 100. In an embodiment, the ridge 120f is configured to restrict the proximal motion of the locking member 160 as explained later.
[41] Fig. 4 illustrates the knob 130 according to an embodiment. The knob 130 is coupled to the connecting element 110 at the proximal end 110a of the connecting element 110. The knob 130 includes a proximal portion 130a and a distal portion 130b. The proximal portion 130a of the knob 130 may have a shape such as without limitation, cylindrical, spherical, etc. In an embodiment, the proximal portion 130a of the knob 130 is cylindrical. The knob 130 is rotatable in clockwise and anti-clockwise directions. In response to the rotation of the knob 130, the connecting element 110 is configured to move longitudinally, for example, due to the threaded coupling of the connecting element 110 with the shaft 120. For example, when the knob 130 is rotated in a first direction (e.g., clockwise), the connecting element 110 moves in a distal direction and when the knob 130 is rotated in a second direction (e.g., anti-clockwise), the connecting element 110 moves in a proximal direction. In an embodiment, the circumference of the proximal portion 130a of the knob 130 may be smooth or may have structural features such as, serrations, grooves, undulating surface, projections, etc., which help in providing a better grip to the user. In an exemplary implementation, the circumference of the proximal portion 130a has an undulating surface as depicted in Fig. 4. The distal portion 130b of the knob 130 has a shape corresponding to the shape of the extension 110c of the connecting element 110. In an embodiment, the distal portion 130b of the knob 130 is tubular, having a longitudinal cavity (not shown) configured to receive the extension 110c of the connecting element 110. The distal portion 130b of the knob 130 may be coupled to the extension 110c of the connecting element 110 via techniques such as, without limitation, welding, threaded joint, press-fit, etc. In an embodiment, the distal portion 130b of the knob 130 has a pair of holes 130b1 corresponding to the hole 110c1 of the connecting element 110. A pin 131 (shown in Fig. 1B) is inserted through the pair of holes 130b1 of the knob 130 and the hole 110c1 of the connecting element 110, thereby coupling the knob 130 with the connecting element 110. The knob 130 may be made of a suitable material, e.g., any medical grade stainless steel. In an embodiment, the knob 130 is made of 17-4 PH stainless steel.
[42] Fig. 5 depicts the holder 140, according to an embodiment of the present disclosure. The holder 140 is situated towards the distal end 100b of the device 100. The holder 140 is adjustably coupled to the shaft 120 at a plurality of transverse positions. In the depicted embodiment, the plurality of transverse positions includes two transverse positions. The holder 140 has a first end 140a and a second end 140b. The holder 140 includes a first portion 140a1 and a second portion 140b1. The first portion 140a1 is provided at the first end 140a of the holder 140. The second portion 140b1 extends from the first portion 140a1 to the second end 140b at a pre-defined angle to the first portion 140a1. The second portion 140b1 is configured to engage with a neck portion of the orthopedic implant. The pre-defined angle facilitates the coupling of the device 100 with the orthopedic implant having the neck portion angled from a longitudinal axis of the body portion of the orthopedic implant. The pre-defined angle depends upon the design of the orthopedic implant. In an embodiment, the pre-defined angle between the first portion 140a1 and the second portion 140b1 is supplementary to an angle between the neck portion of the orthopedic implant and the longitudinal axis of the body portion of the orthopedic implant. The first portion 140a1 includes a first arm 142a and a second arm 142b separated by a distance, defining an opening 140c therebetween. The opening 140c extends from the first end 140a towards the second end 140b. In an embodiment, the opening 140c has a rectangular shape. The opening 140c is configured to receive the grooved portion 120d1 of the shaft 120. The first arm 142a and the second arm 142b are slidable within the respective groove 120d. In an embodiment, an inner face of each of the first arm 142a and the second arm 142b is configured to reside within a corresponding groove 120d of the pair of grooves 120d of the shaft 120. The height of the first arm 142a and the second arm 142b corresponds to the height of the pair of grooves 120d of the shaft 120. The width of the opening 140c corresponds to the distance between the grooves 120d. The slidable coupling between the first and the second arms 142a, 142b and the pair of grooves 120d allows the movement of the holder 140 relative to the shaft 120 in a transverse direction. The transversal position of the holder 140 may be adjusted based upon the type and/or the size of the orthopedic implant by sliding the holder 140 in a transverse direction. In other words, the first arm 142a and the second arm 142b may be slid within the grooves 120d to set the holder 140 at a desired transverse position of the plurality of transverse positions according to at least one of: the type or the size of the orthopedic implant. In an embodiment, the desired transverse position is chosen according to both the type and size of the orthopedic implant. In an embodiment, each transverse position may correspond to at least one configuration of the orthopedic implant. Each configuration of the orthopedic implant represents a type and a size of the orthopedic implant and may be indicated by an ordered pair of characters (alphabets, numbers, alphanumeric or the like). By way of example, the configuration N1 (‘N’ and ‘1’ forming an ordered pair) represents a narrow femoral stem of size 1, the configuration S3 (‘S’ and ‘3’ forming an order pair) represents a standard femoral stem of size 3 and so forth. When the holder 140 is set to a given transverse position, the device 100 is capable coupling with and inserting an orthopedic implant having any configuration corresponding to the transverse position. Therefore, a desired transverse position is selected based upon the configuration (i.e., based upon the type and size) of the orthopedic implant to be inserted using the device 100. Preferably, each transverse position corresponds to two or more configurations of the orthopedic implant. This ensures optimal size of the device 100 while maintaining the flexibility of coupling the device 100 with orthopedic implants of different types and sizes. In the depicted embodiment, one of the transverse positions corresponds to femoral stems of configurations S0 and N1 (shown in Fig. 1C) and the holder 140 is set at this transverse position for inserting S0 or N1 femoral stems. Similarly, the other transverse position corresponds to femoral stems of configurations N2, N3, N4, S1, S2, S3 and S4, and the holder 140 is set at this transverse position for inserting a femoral stem of these configurations. Thus, the adjustable coupling between the shaft 120 and the holder 140 enables the device 100 to be coupled with orthopedic implants of different types and/or sizes.
[43] The first portion 140a1 of the holder 140 may be provided with a first hole 141a and a second hole 141b provided on the first arm 142a and the second arm 142b respectively. The first hole 141a and the second hole 141b may be provided towards the first end 140a of the holder 140. In an embodiment, the first hole 141a and the second hole 141b may have different diameters. Each of the first hole 141a and the second hole 141b are configured to receive a portion of the restraining member 190 (shown in Fig. 1E). In an embodiment, the dimensions of the first hole 141a and the second hole 141b depends on the dimensions of the restraining member 190. The holder 140 is provided with a plurality of markings. Each of the plurality of markings corresponds to one transverse position of the plurality of transverse positions and indicates the corresponding at least one configuration of the orthopedic implant at the transverse positions. In an embodiment, the markings include an arrow pointing to the corresponding transverse positions and text N1, N2, N3, N4, S0, S1, S2, S3, S4 denoting the respective configurations (as shown in Figs. 3C and 3D). The plurality of markings may be provided on at least one of the first arm 142a or the second arm 142b. In the depicted embodiment shown in Figs. 3C and 3D, one marking is provided on each of the first arm 142a and the second arm 142b. The plurality of markings visually guides a medical practitioner to slide the holder 140 to a desired transverse position. Further, the holder 140 has a plurality of first grooves, for example, first grooves 143a, 143b, provided on the first arm 142a and a plurality of second grooves, for example, second grooves 144a, 144b, provided on the second arm 142b. The plurality of first grooves 143a, 143b and the plurality of second grooves 144a, 144b are provided on a proximal face of the first arm 142a and the second arm 142b, respectively. Each of the second groove 144a, 144b is aligned with a respective one of the first grooves 143a, 143b. Each of the first grooves 143a, 143b and the second grooves 144a, 144b correspond to one of the transverse positions. The plurality of first grooves 143a, 143b and the plurality of second grooves 144a, 144b are used to lock the holder 140 with the shaft 120 at the desired transversal position using the locking member 160 as explained later. The number of first grooves 143a, 143b and the second grooves 144a, 144b correspond to the number of transverse positions. In the depicted embodiment, the holder 140 has two first grooves 143a, 143b and two second grooves 144a, 144b. In an embodiment, the first groove 143a and the second groove 144a correspond to the transverse position for S0 and N1 femoral stems, whereas the first groove 143b and the second groove 144b correspond to the transverse position for N2, N3, N4, S1, S2, S3 and S4 femoral stems.
[44] The second portion 140b1 of the holder 140 is provided with a first slot 140d. The first slot 140d of the holder 140 is configured to receive at least a portion of the cap 150. The first slot 140d may have a shape such as without limitation, circular, oval, rectangular, etc. In an embodiment, the first slot 140d is oval shaped. The second portion 140b1 may optionally be provided with a second slot 140e. The second slot 140e is generally rectangular having curved ends, though it may have any other suitable shape. The second slot 140e is provided to reduce overall weight of the device 100.
[45] Fig. 6 illustrates an exemplary cap 150. The cap 150 has a cross-sectional shape corresponding to that of the first slot 140d of the holder 140. The cap 150 includes a body 150d and a lip 150c. The lip 150c extends from the body 150d and is provided towards a proximal end of the cap 150. The body 150d includes a cavity 150a. The cavity 150a is configured to receive the neck portion of the orthopedic implant. The body 150d is disposed within the first slot 140d of the second portion 140b1. The lip 150c may be disposed outside at either proximal end or a distal end of the first slot 140d. In an exemplary embodiment, the lip 150c is disposed at the distal end of the first slot 140d of the holder 140. The dimensions of the body 150d corresponds to the dimensions of the first slot 140d of the second portion 140b1. The cap 150 is coupled with the first slot 140d of the second portion 140b1 via a technique such as snap fit, press fit, etc. In an embodiment, the cap 150 is fitted inside the first slot 140d via a snap fit technique. The cap 150 may have a shape such as, without limitation, conical, cylindrical, etc. In an embodiment, the cap 150 has a conical shape. The cap 150 may be made of a suitable material, e.g., a high-performance polymer. In an embodiment, the cap 150 is made of polyphenylsulfone (e.g., Radel R 5000).
[46] Fig. 7 depicts the restraining member 190, according to an embodiment. The restraining member 190 is coupled to the first arm 142a and the second arm 142b of the holder 140. The restraining member 190 may have a tubular structure. The restraining member 190 includes a first portion 190a and a second portion 190b. The first portion 190a and the second portion 190b is at least partially disposed in, coupled with, the first hole 141a and the second hole 141b respectively, thereby coupling the restraining member 190 with the holder 140. In an embodiment, the first portion 190a fully resides in the first hole 141a and the second portion 190b partially resides in the second hole 141b. The first portion 190a and the second portion 190b may have the same or different diameters. In an embodiment, the second portion 190b has a larger diameter than the first portion 190a. The larger diameter of the second portion 190b restricts the first portion 190a from moving out of the first hole 141a from the other direction, thereby preventing potential slippage of the restraining member 190 from the holder 140. Optionally, the second portion 190b and/or the first portion 190a may be provided with threads (not shown) on its outer surface for at least a partial length of the respective portion. These threads may engage with corresponding threads provided in the first hole 141a and the second hole 141b, thereby locking the restraining member 190 in a position as shown in Fig. 1D. The restraining member 190 is configured to restrain the transverse motion of the holder 140 and prevents the holder 140 from being detached from the device 100. The restraining member 190 may be made of a suitable material, e.g., any medical grade stainless steel. In an embodiment, the restraining member 190 is made of 17-4 PH stainless steel.
[47] The locking member 160 is configured to lock the shaft 120 with the holder 140 at the desired transverse position. The locking member 160 is provided proximal to the holder 140. Fig. 8 depicts an exemplary locking member 160 according to an embodiment. In an embodiment, the locking member 160 has a cylindrical, tubular structure, though it may have any other suitable shape. In an embodiment, the locking member 160 is slidably disposed over the shaft 120. The locking member 160 is positioned between a proximal end of the pair of grooves 120d and the ridge 120f. The locking member 160 is capable of sliding in a longitudinal direction over the shaft 120. The locking member 160 is used to lock and unlock the holder 140 from the shaft 120, preventing/allowing transversal movement of the holder 140. The locking member 160 includes a resilient member 170. In an embodiment, the locking member 160 includes a cavity 161 extending longitudinally from a proximal end to a distal end of the locking member 160. The ridge 120f is disposed within the cavity 161. In a locked state (i.e., when the locking member 160 is coupled to the holder 140), the ridge 120f is at a proximal end of the cavity 161. The resilient member 170 is disposed within the cavity 161 and resides between the ridge 120f and the distal end of the cavity 161 as shown in Fig. 1F. The resilient member 170 facilitates the movement of the locking member 160. For example, in the locked state, the resilient member 170 is at a rest state, and prevents any unwanted proximal movement of the locking member 160 unless a force is applied. When the use slides the locking member 160 in the proximal direction, the resilient member 170 is compressed and applies a resilient force to return the locking member 160 to its original position once the user releases the locking member 160. In an embodiment, the resilient member 170 includes a spring, for example, a compression spring. The locking member 160 includes a first projection 160a1 and a second projection 160a2 provided on diametrically opposite sides of the locking member 160 at the distal end of the locking member 160. The first projection 160a1 is configured to engage with the first grooves 143a, 143b and the second projection 160a2 is configured to engage with the second grooves 144a, 144b, thereby locking the relative position of the shaft 120 and the holder 140. When the first projection 160a1 and the second projection 160a2 engage with a desired one of the first grooves 143a, 143b and a desired one of the second grooves 144a, 144b, the shaft 120 is locked with the holder 140 at the desired transverse position. The desired one of the first grooves 143a, 143b and the second grooves 144a, 144b correspond to the desired transverse position. The locking member 160 may optionally be provided with a plurality of annular grooves 162 on its periphery defining a passage, which helps in cleaning, disinfecting and sterilizing the resilient member 170. The locking member 160 may be made of a suitable material, e.g., any medical grade stainless steel. In an embodiment, the locking member 160 is made of 17-4 PH stainless steel. The locking member 160 described herein is merely exemplary and should not be considered as limiting. The locking member 160 may include any other functionally equivalent assemblies capable of locking the shaft 120 with the holder 140 at the desired transverse position. Examples of such assemblies include, without limitation, a threaded knob, a rack-and-pinion assembly, a cam follower assembly, or the like.
[48] Optionally, the device 100 includes a flange 180. Fig. 8 depicts an exemplary flange 180 according to an embodiment. The flange 180 is coupled with the shaft 120 at the proximal end 120a of the shaft 120 (as shown in Fig. 1). The flange 180 may be coupled to the shaft 120 via techniques such as, without limitation, snap-fit, welding, etc. In an embodiment, the flange 180 is coupled to the shaft 120 via a welding technique. For example, a cavity 180a may be provided in the flange 180 to receive the proximal portion 120c of the shaft 120. The cavity 180a extends between a proximal end and a distal end of the flange 180. The inner diameter of the cavity 180a may match with the outer diameter of the proximal portion 120c such that they fit together snugly. The flange 180 has a cylindrical body, though it may have any other suitable shape. The flange 180 may be provided with a pair of arms 180c, provided opposite to each other. The arms 180c extend outward. Each of the arms 180c may have an opening provided at a respective lateral end and configured to couple with an ante version handle to provide rotational stability to the device 100. In an embodiment, each opening is provided with internal threads configured to couple with the respective ante version handle. It may be understood that the arms 180c may be provided with other locking mechanism to lock the ante version handle with the flange 180.
[49] An embodiment of operating the device 100 is now explained. To assemble the device 100, the connecting element 110 is disposed inside the cavity 120e and coupled with the shaft 120 via the threaded mechanism. The knob 130 is then coupled to the connecting element 110 as described earlier. During the implantation procedure, the locking member 160 is pulled in the proximal direction, disengaging the first projection 160a1 and the second projection 160a2 from the respective first groove 143a, 143b and the second groove 144a, 144b, thus, unlocking the holder 140. The holder 140 is now moved transversely to a desired transverse position according to the type and the size of a femoral stem (e.g., a femoral stem 200) by sliding the first arm 142a and the second arm 142b within the respective groove 120d. For example, the holder 140 is moved such that the first projection 160a1 and the second projection 160a2 align with the desired first groove (in the depicted example, the first groove 143b) and the second groove (in the depicted example, the second groove 144b), respectively. The plurality of markings on the holder 140 assist the user to select the appropriate first and second grooves 143b, 144b) and set the holder 140 at the desired transversal position. The locking member 160 is then released. The resilient member 170 provides the resilient force to pull the locking member 160 downwards (i.e., in the distal direction). The first projection 160a1 and the second projection 160a2 provided on the locking member 160 engage with the first groove 143b and the second groove 144b on the holder 140, thereby locking the holder 140 at the desired transverse position. Further, the user rotates the knob 130 in a counter clockwise direction causing the connecting element 110 to move in the proximal (i.e., upward) direction. The trunnion of the femoral stem 200 is disposed inside the cavity 150a of the cap 150, coupling a neck portion 202 of the femoral stem 200 with the second portion 140b1 of the holder 140. The user then rotates the knob 130 in a clockwise direction. This causes the connecting element 110 to move in a distal (i.e., downward) direction. The user rotates the knob 130 in the clockwise direction until the distal tip 110d of the connecting element 110 fits into a corresponding hole (not shown) provided on a body portion 201 of the femoral stem 200. Thus, the device 100 is coupled with the femoral stem 200 as depicted in Fig. 10. The femoral stem 200 can then be securely pushed into the medullary canal of the patient until the femoral stem 200 reaches a desired position. The user can then rotate the knob 130 in the counter clockwise direction. As a result, the connecting element 110 moves in the upward direction, causing the distal tip 110d of the connecting element 110 to disengage from the femoral stem 200.
[50] The device of the present disclosure presents several advantages. For example, the device is adjustable to be coupled with orthopedic implants, such as femoral stems, of different sizes and/or types. This enhances the usability of the proposed device for a wide range of femoral stems unlike the conventional devices, where one conventional device can be used only for one size/type of the femoral stem. Consequently, the proposed device reduces the inventory required for an implantation procedure and hence, the overall cost of the medical procedure. Locking the trunnion of the femoral stem with the proposed device prevents misalignment during insertion and increases precision. This prevents further complications such as pain and damage to the tissues of the targeted area, thereby improving the overall patient outcome.
[51] 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. A device (100) for inserting an orthopedic implant, the device (100) comprising:
a. a connecting element (110) comprising a distal tip (110d) configured to engage with a body portion of an orthopedic implant;
b. a shaft (120) coupled to the connecting element (110), the shaft (120) comprising:
i. a cavity (120e) extending at least partially along the length of the shaft (120) and configured to accommodate a portion of the connecting element (110); and
ii. a pair of grooves (120d); and
c. a holder (140) adjustably coupled to the shaft (120) at a plurality of transverse positions, the holder (140) comprising:
i. a first portion (140a1) provided at a first end (140a) of the holder (140) and having a first arm (142a) and a second arm (142b), the first arm (142a) and the second arm (142b) defining an opening (140c) therebetween, the opening (140c) configured to receive a grooved portion (120d1) of the shaft (120); and
ii. a second portion (140b1) extending from the first portion (140a1) of the holder (140) to a second end (140b) of the holder (140) at a pre-defined angle and configured to engage with a neck portion of the orthopedic implant;
d. wherein the first arm (142a) and the second arm (142b) are slidable within the respective groove (120d) of the shaft (120);
e. wherein the first arm (142a) and the second arm (142b) are slid to set the holder (140) at a desired transverse position of the plurality of transverse positions according to at least one of: a type or a size of the orthopedic implant.
2. The device (100) as claimed in claim 1, wherein the connecting element (110) comprises a threaded portion (110e) having outer threads (110e1) provided on an outer surface of the threaded portion (110e) and configured to engage with the inner threads (120i1) provided on an inner surface of the cavity (120e) of the shaft (120).
3. The device (100) as claimed in claim 1, wherein the device (100) comprises a knob (130) coupled to the connecting element (110) at a proximal end (110a) of the connecting element (110), wherein in response to the rotation of the knob (130), the connecting element (110) is configured to move longitudinally.
4. The device (100) as claimed in claim 1, wherein the device (100) comprises a cap (150) comprising a body (150d) disposed within a first slot (140d) provided in the second portion (140b1) and a lip (150c) disposed outside of the first slot (140d), the body (150d) of the cap (150) comprising a cavity (150a) configured to receive the neck portion of the orthopedic implant.
5. The device (100) as claimed in claim 1, wherein the device (100) comprises a locking member (160) configured to lock the shaft (120) with the holder (140) at the desired transversal position.
6. The device (100) as claimed in claim 5, wherein:
a. the holder (140) comprises:
i. a plurality of first grooves (143a, 143b) provided on the first arm (142a); and
ii. a plurality of second grooves (144a, 144b) provided on the second arm (142b), each of the plurality of second grooves (144a, 144b) is aligned with a respective one of the plurality of first grooves (143a, 143b);
iii. wherein each of the plurality of first grooves (143a, 143b) and the plurality of second grooves (144a, 144b) corresponds to one transverse position of the plurality of transverse positions; and
b. the locking member (160) is slidably disposed over the shaft (120) and comprises:
i. a first projection (160a1) provided at a distal end of the locking member (160) and configured to engage with the plurality of first grooves (143a, 143b); and
ii. a second projection (160a2) provided at the distal end of the locking member (160) and configured to engage with of the plurality of second grooves (144a, 144b),
c. wherein when the first projection (160a1) and the second projection (160a2) engage with a desired first groove (143a, 143b) and second groove (144a, 144b), respectively, the shaft (120) is locked with the holder (140) at the desired transverse position.
7. The device (100) as claimed in claim 6, wherein the locking member (160) includes a resilient member (170) disposed within a cavity (161) of the locking member (160).
8. The device (100) as claimed in claim 6, wherein the shaft (120) comprises a ridge (120f) provided on the shaft (120) proximal to the pair of grooves (120d) at a pre-defined distance, the ridge (120f) configured to restrict a proximal motion of the locking member (160).
9. The device (100) as claimed in claim 1, wherein each of the plurality of transverse positions corresponds to at least one configuration of the orthopedic implant, each configuration representing the type and the size of the orthopedic implant.
10. The device (100) as claimed in claim 9, wherein each of the plurality of transverse positions corresponds to two or more configurations of the orthopedic implant.
11. The device (100) as claimed in claim 1, wherein the device (100) comprises a restraining member (190) coupled to the first arm (142a) and the second arm (142b) of the first portion (140a1) of the holder (140).
12. The device (100) as claimed in claim 11, wherein the restraining member (190) comprises a first portion (190a) partially disposed in a first hole (141a) of the first arm (142a) and a second portion (190b) partially disposed in a second hole (141b) of the second arm (142b).
13. The device (100) as claimed in claim 1, wherein the device (100) comprises a flange (180) coupled to the shaft (120) at a proximal end (120a) of the shaft (120), the flange (180) comprising:
a. a cavity (180a) configured to receive a proximal portion (120c) of the shaft (120); and
b. a pair of arms (180c) extending outwards, each of the pair of arms (180c) having an opening configured to couple with an ante version handle.