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

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

FIELD OF INVENTION
[1] The present disclosure relates to a medical device. More particularly, the present disclosure relates to an intravertebral implant.
BACKGROUND OF INVENTION
[2] Spine (or vertebrae) is the central support structure of our body that allows us to stand upright, bend, and twist. Poor living habits and unhealthy lifestyle may cause a number of spinal disorders such as ankylosing spondylitis, back pain, basilar invagination, basilar impression, cranial settling, chronic spine and back pain kyphosis, etc.
[3] An implant may be implanted into the intervertebral space to provide structural support and facilitate the fusion between the adjacent vertebrae. Conventionally, implants come in various pre-determined dimensions to accommodate patient’s anatomy. Surgeons may select the most appropriate implant to best fit the patient's anatomy based on preoperative imaging and intraoperative measurements.
[4] However, the need to choose the appropriate implant for each patient may add complexity to the preparation process. Incorrect selection due to carrying patient’s anatomy may lead to uneven load-distribution on the vertebral endplates. This may increase the risk of subsidence, where the implant sinks with the bone, leading to loss of height and alignment issues. The improper alignment may lead to compromised optimal support or restoration of the intervertebral height, potentially impacting the success of the surgical or imaging procedure. The inadequate restoration of the intervertebral height may fail to sufficiently decompress neural structures (example nerves or the spinal cord) leading to persistent or recurrent pain, numbness, or weakness. Inadequate stabilization of spine may lead abnormal movement between vertebral bodies and contribute to instability and pain. Improper placement of the implant may lead to suboptimal conditions for bone graft fusion. The suboptimal conditions may result in non-union or pseudarthrosis, which may cause persistent pain and may necessitate revision surgery.
[5] Due to the pre-determined dimensions, the implant may lack adjustability and adaptability to perfectly match the patient’s anatomy. Intraoperative adjustments may not be possible during the surgery to fit the implant in the intervertebral space due to fixed dimensions of the implant. This may create pressure against the vertebral bodies, which may result in grinding or damaging the vertebral bodies as the surgeon attempts to position the implant. The grinding of the vertebral bodies against the implant may lead to additional bleeding and bone fragmentation, causing an immediate trauma to the vertebral endplates. Furthermore, misfitting the implant may prolong the surgery as the surgeon may need to take multiple attempts to fit the implant properly or even switch to a different size, which increases the risk of complications. Also, procurement of a wide range of implants may be required to ensure that all necessary sizes are available when needed. This may increase the inventory and requirement of extensive storage space for the implants.
[6] Therefore, there is a need to devise an intervertebral implant that precisely fits into a vertebrate of a patient and mimics the natural intervertebral disc’s height and alignment, and overcomes the problems associated with the conventional implants.
SUMMARY OF INVENTION
[7] 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.
[8] The present disclosure relates to an intervertebral implant. The implant has a first end and a second end. The implant includes a first body, a second body, at least one set of resilient connectors and an expandable assembly. The first body and the second body include a corresponding outer surface and a corresponding inner surface. The first body is in close proximity to the second body. The at least one set of resilient connectors are disposed on at least one end of the first body and the second body and couples the first body to the second body. The expandable assembly is at least partially disposed between the first body and the second body. The expandable assembly includes a triggering mechanism and an expansion member. The expansion member is configured to either expand or collapse a gap between the first body and the second body upon receiving a trigger from the triggering mechanism. The resilient connectors are configured to recalibrate corresponding to the gap leading to change in height of the implant.
BRIEF DESCRIPTION OF DRAWINGS
[9] 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.
[10] Fig. 1 depicts a top view of an implant 100, according to an embodiment of the present disclosure.
[11] Fig. 1a depicts a rear perspective view of the implant 100, according to an embodiment of the present disclosure.
[12] Fig. 2 depicts a cross-sectional view of the implant 100, according to an embodiment of the present disclosure.
[13] Fig. 3 depicts an expandable assembly 170 of the implant 100, according to an embodiment of the present disclosure.
[14] Fig. 3a depicts an exploded view of the expandable assembly 170 of the implant 100, according to an embodiment of the present disclosure.
[15] Fig. 4 depicts an exemplary method 400 to expand the implant 100, according to an embodiment of the present disclosure.
[16] Fig. 4a depicts an exemplary method 500 to collapse the implant 100, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[17] 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.
[18] 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.
[19] 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.
[20] 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.
[21] The present disclosure relates to an intravertebral implant (or implant). The implant is implanted between two consecutive vertebrae of a diseased spine to restore the structure and function of the diseased spine.
[22] The implant of the present disclosure has an adjustable height. The implant is designed such that the height of the implant can be easily adjusted by a medical practitioner. In an embodiment, the implant includes a triggering mechanism. The triggering mechanism enables a user to adjust the implant to an exact height needed for each patient with respect to the height of the inter-vertebral space. In an embodiment, the implant includes at least one set of resilient connectors (hereinafter, resilient connectors). The resilient connectors are configured to provide support and stability to the implant within the inter-vertebral spaces.
[23] The height adjustment provision of the implant ensures perfect fit of the implant between the inter-vertebrate space. The custom adjustability of the implant may enhance the optimal support and restoration of the intervertebral height., Unlike the conventional implant, the implant of the present disclosure reduces the risk of complications such as subsidence and migration, and associated problems. The implant promotes even load-distribution and helps in maintaining the natural curvature and mechanics, thereby reducing the discomfort and the risk of further degeneration or injury. Further, the resilient connectors facilitate bone in-growth and help the implant to fuse with the spine, leading to successful and quicker recovery. Further, the height adjustment provision of the implant eliminates the need for manufacturing multiple implants, each of a specified height, hence saving manufacturing costs.
[24] Further, due to adjustable height of the implant, the implant can be inserted into a patient via a smaller incision in a collapsed state and thereafter expanded to the required height. This potentially leads to less tissue disruption, faster recovery times, and/or reduced surgical site infections.
[25] The adjustability of the implant as disclosed in the present disclosure eliminates the need of conventional implants having fixed dimension. Due to adjustability of the implant of the present disclosure, the implant can cater to a diseased spine of various patients having different heights between two consecutive vertebrae of a spine. This eliminates the need to choose an appropriate implant for each patient as required in conventional setups for each surgery. As a result, the number of attempts and time required to fit the implant of the present disclosure into the intervertebral space is also reduced as compared to the attempts that were made by the surgeon while using the conventional implant during the surgery.
[26] Further, the height adjustment provision of the implant eliminates the need for manufacturing multiple implants, each of a specified height, hence saving manufacturing costs.
[27] Now referring to figures. Figs. 1 and 1a depict an exemplary implant 100. The implant 100 includes a first body 110, a second body 130, at least one set of resilient connectors 151 and an expandable assembly 170. The implant 100 may be made of any suitable biocompatible material including, but not limited to, titanium, hardened stainless steel, Polyether ketone (PEEK), etc. In an exemplary embodiment, the implant 100 is made of PEEK.
[28] The implant 100 includes a first end 100a, a second end 100b, a third end 100c and a fourth end 100d. In the depicted figure, the first end 100a is opposite to the second end 100b. Likewise, the third end 100c is opposite to the fourth end 100d. The length of the implant 100 is defined as the distance between the first end 100a and the second end 100b. The width of the implant 100 is defined as the distance between the third end 100c and the fourth end 100d. The height of the implant 100 is defined as the distance between the outer surface of the first body 110 and the outer surface of the second body 130.
[29] In an embodiment, the height of the implant 100 is adjusted with the help of the expandable assembly 170 as needed, according to a patient’s anatomy (explained later).
[30] The first body 110 may have a pre-defined shape including, but not limited to, cuboidal, cubical, cylindrical, triangular, etc. In an exemplary embodiment, as shown in Fig. 1, the first body 110 is cuboidal shaped. The first body 110 includes an outer surface and an inner surface. The outer surface may be bounded by at least one of a beveled edge, a chamfered edge, a fillet edge, or a combination thereof. In an exemplary embodiment, as shown in Figs. 1 and 1a, towards the first end 100a, the outer surface of the first body 110 is provided with a fillet edge. And, towards the second end 100b, the outer surface of the first body 110 is provided with a chamfered edge. The fillet edge and the chamfered edge of the implant 100 help in easy insertion of the implant 100 in the implantation site.
[31] At least a portion of the outer surface of the first body 110 is provided with a plurality of ridges 111. The ridges 111 may have a pre-defined pattern including, but not limited to, linear, zig-zag, spiral, etc. In an exemplary embodiment, as shown in Figs. 1 and 1a, the ridges 111 of the first body 110 are arranged linearly such that each of the ridge 111 extends between the third end 100c and the fourth end 100d. The ridges 111 help the implant 100 to grip the surrounding bone at the implantation site.
[32] The first body 110 is provided with at least one hole 113 extending from the outer surface of the first body 110 to the inner surface of the first body 110. The hole 113 helps to add cement within the implant 100 after it is implanted at the implantation site. The cement helps in fixation of the implant 100 at the implantation site.
[33] The inner surface of the first body 110 is provided with a groove 115 (depicted in Fig. 2). The groove 115 extends from the first end 100a to the second end 100b. The groove 115 is configured to at least partially receive/enclose a portion of the expandable assembly 170 (explained later). Further, the groove 115 is in fluid communication with the hole 113.
[34] In an embodiment, the second body 130 is a mirror image of the first body 110. Therefore, it should be understood that structure, components and functions of the second body 130 can be understood from that of the first body 110 and hence, not repeated for the sake of brevity. The first body 110 and the second body 130 may have pre-defined dimensions that depend upon a patient’s anatomy.
[35] The first body 110 is in close proximity to the second body 130. Specifically, the inner surface of the second body 130 is in close proximity to the inner surface of the first body 110. In an exemplary embodiment, the inner surface of the first body 110 and the inner surface of the second body 130 are coupled to each other with the help of at least one set of resilient connectors 151 (hereinafter, referred as resilient connectors 151), as shown in Figs. 1a-2. The resilient connectors 151 are disposed on at least one end of the first body 110 and the second body 130.
[36] In an exemplary embodiment, the set of resilient connectors 151 includes a first set of resilient connectors and a second set of resilient connectors 151. The first set of resilient connectors 151 and the second set of resilient connectors 151 are disposed on opposite sides between the first body 110 and the second body 130. For example, the first set of resilient connectors 151 couples the third end 100c of the first body 110 to the third end 100c of the second body 130. And, a second set of the resilient connectors 151 couples the fourth end 100d of the first body 110 to the fourth end 100d of the second body 130. In an exemplary embodiment, the first set of resilient connectors 151 and the second set of resilient connectors 151 include four resilient connectors 151 each.
[37] The resilient connectors 151 may be of a pre-defined thickness that, in turn, depends on the patient’s bone anatomy. In an exemplary embodiment, the resilient connectors 151 are arranged parallel to each other and are spaced evenly. Alternately, the resilient connectors 151 may include a crisscross arrangement. The resilient connectors 151 may include branched design. The resilient connectors 151 may be made of one or more of a biocompatible, biodegradable and/or self-expandable material, such as, without limitation, silicone rubber, polyethene (PE), acrylic resins, polyurethanes, or polypropylene, etc. In an exemplary embodiment, the resilient connectors 151 are made of acrylic resins.
[38] The resilient connectors 151 are configured to recalibrate corresponding to the gap leading to change in height of the implant 100. In other words, the resilient connectors 151 are configured to change its structural conformation with respect to the change in the gap between the first body 110 and the second body 130. In an embodiment, the structural conformation may change due to the shape memory properties of the self-expanding material of the resilient connectors 151. The resilient connectors 151 thus retain the ability to move between an at least partially stretched position and an un-stretched position causing conformational changes in the resilient connectors 151, thereby recalibrating the resilient connectors 151. The resilient connectors 151 allow the first body 110 and the second body 130 to either axially move close or away from each other depending on the expandable assembly 170 (described later). In an exemplary embodiment, the resilient connectors 151 are biased to remain in the un-stretched position, when the first body 110 and the second body 130 are close to each other. In an embodiment, the biasness of the resilient connectors 151 is due to the shape memory of the resilient connectors 151.
[39] The present disclosure is explained with the help of the resilient connectors made of polymeric material. It should be understood that the term “resilient connectors” is used broadly to encompass various components that provide the same flexibility and functionality. The components including, without limitations, springs, foam or any other flexible components that can be used to achieve similar results in coupling the first body to the second body and achieve the similar resilience for conformational changes.
[40] In an exemplary embodiment, the at least one sets of resilient connectors 151 are coupled to the first body 110 and the second body 130 using snap-fit locking mechanism. It should be noted that any other suitable locking mechanism may be used to couple the resilient connectors 151 to the first body 110 and the second body 130.
[41] The expandable assembly 170 is at least partially disposed between the first body 110 and the second body 130. Specifically, the expandable assembly 170 is at least partially disposed within the grooves 115 and 135 of the first body 110, and the second body 130, respectively.
[42] The expandable assembly 170 of the implant 100 is depicted in Fig. 3-3a. In an exemplary embodiment, the expandable assembly includes a triggering mechanism and an expansion member 173. The triggering mechanism includes a plurality of components operatively coupled to each other and/or the expansion member 173. The expansion member 173 is configured to move between an expanded state and a collapsed state upon receiving a trigger from the triggering mechanism. The movement of the expansion member 173 between the expanded state and the collapsed state defines the overall gap between the first body 110 and the second body 130 of the implant 100 to be achieved in the intervertebral space of the spine.
[43] In an exemplary embodiment, the triggering mechanism includes a mounting member 171 and a trigger 175. The mounting member 171 includes a head 171a, and a shank 171b. The first end 100a of the implant 100 receives the mounting member 171. The head 171a is disposed towards the first end 100a of the implant 100 when the expandable assembly 170 is at least partially disposed within the groove 115, 135. The head 171a restricts any relative motion of the mounting member 171 with the first body 110, and the second body 130.
[44] The head 171a may have a pre-defined shape including, but not limited to, circular, elliptical, square, polygonal, etc. In an exemplary embodiment, as shown in Figs. 3 and 3a, the head 171a is circular shaped. The head 171a may be coupled to the shank 171b using any mechanisms or techniques, such as, without limitation, snap-fit locking mechanism, adhering techniques. In an exemplary embodiment, the head 171a forms an integral structure with the shank 171b.
[45] In an exemplary embodiment, the shank 171b is cylindrically shaped. However, the shank 171b may include other shapes that can work as per the teachings of the present disclosure. The shank 171b extends from a first end to a second end, thereby defining a length. The first end of the shank 171b is coupled to the head 171a. The shank 171b has a diameter less than a diameter of the head 171a. In an exemplary embodiment, the shank 171b is provided with a plurality of external threads 171c at least a partial length towards the second end of the shank 171b. The length of the shank 171b depends upon the length of the implant 100.
[46] The mounting member 171 may be made of any suitable material, including, but not limited, stainless-steel, titanium, cobalt-chromium (CoCr) alloy, nitinol. In an exemplary embodiment, the mounting member 171 is made of stainless-steel.
[47] The mounting member 171 is operatively coupled to the trigger 175. The second end 100b of the implant 100 receives the trigger 175. The trigger 175 is rotatable both in a clockwise direction and an anticlockwise direction. In an exemplary embodiment, the trigger 175 includes a trigger body 175a and a head 175b. The trigger body 175a is generally cylindrical in shape. The shape of the trigger body 175a corresponds to the shape of the shank 171b of the mounting member 171. The trigger body 175a is provided with a plurality of internal threads (not shown) extending at least partially along a length of the trigger 175. Upon mating of the plurality of internal threads of the trigger 175 with the plurality of external threads 171c of the shank 171b (and/or mounting member 171), the trigger 175 is configured to rotate forward or backward along at least a portion of the length of the shank 171b. For example, when the trigger 175 is rotated in a clockwise direction, it moves backward (i.e., towards the head 171a of the mounting member 171. And, when the trigger 175 is rotated in an anti-clockwise direction, the trigger 175 moves forward (i.e., away from the head 171a of the mounting member 171. The head 175b is generally disc bowl in shape. Alternately, the head 175b may be round, hexagon, etc. The head 175b may be flat. In the depicted embodiment, the head 175b include carvings complementary to a tip of a jack (not shown). The carvings in the head 175b are configured to engage with the tip of the corresponding jack. The user may rotate the trigger 175 manually or with the help of the jack in a desired direction along at least a portion of the length of the shank 171b.
[48] Though the present disclosure uses a screw-thread coupling mechanism for coupling the mounting member with the trigger. It should be understood that other suitable coupling mechanism including, but not limited to, rack-pinion, cam-follower, slotted ball-plunger mechanism, etc. can be employed, independently or in combination, to achieve the same functionality without deviating from the teachings of the present disclosure.
[49] The trigger 175 may be made of any suitable material, such as, without limitation, stainless steel, titanium, cobalt-chrome (CoCr) alloy, nitinol, etc., or a combination thereof. In an exemplary embodiment, the trigger 175 is made of stainless steel.
[50] The expansion member 173 is substantially a hollow, tubular structure. In an exemplary embodiment, the expansion member 173 includes a first portion 173a, a second portion 173b and a third portion 173c. The first portion 173a and the third portion 173c includes a corresponding lumen (namely, the first lumen and the third lumen). The first lumen and the third lumen receive the mounting member 171. In an exemplary embodiment, the first portion 173a abuts the head 171a of the mounting member 171. In an embodiment, the first portion 173a is fixedly coupled close to the head 171a of the mounting member 171.
[51] The third portion 173c receives the trigger 175. The third portion 173c may be coupled to the trigger 175 using any suitable mechanism, such as, without limitation, sliding-mechanism, threaded-coupling, rack-pinion, cam follower, ball-plunger mechanism, etc. In one depicted embodiment, the trigger 175 is slidably disposed within the third lumen of the third portion 173c. In another embodiment, an inner surface of the third portion 173c may include a threaded portion configured to mate a corresponding threaded portion an outer surface of the trigger 175.
[52] The first portion 173a, the second portion 173b and the third portion 173c of the expansion member 173 may be made one of a material, including, but not limited to, stainless steel (SS), titanium, Cobalt chromium (CoCr), nitinol, etc., or a combination thereof. In an exemplary embodiment, the expansion member 173 is made of SS.
[53] The second portion 173b is sandwiched between the first portion 173a and the third portion 173c. The second portion 173b is configured to expand radially. The second portion 173b may be any component suitable to expand, such as without limitation, a strut, an inflatable balloon, etc. In an exemplary embodiment, the second portion 173b is provided with a plurality of struts 173b1. The plurality of struts 173b1 may be made one of a material, including, but not limited to, stainless steel (SS), titanium, Cobalt chromium (CoCr), nitinol, etc., or a combination thereof. In an exemplary embodiment, the plurality of struts 173b1 is made of SS. Though the struts of the second portion described in the present disclosure are exemplarily made of same material as the first portion and the third portion of the expansion member, however, it should be understood that the struts may be made of any suitable material depending upon the type of component being used, provided that the functionality described herein is achieved without deviating the teachings of the present disclosure.
[54] The struts 173b1 are configured to move between an expanded state and a collapsed state. For example, the struts 173b1 are configured to radially expand when the third portion 173c is pushed closer to the first portion 173a of the expansion member 173. Conversely, the struts 173b1 are configured to radially collapse when the third portion 173c is pulled away from the first portion 173a. In an exemplary embodiment, the struts 173b1 are biased to remain in the collapsed state.
[55] In response to the rotation of the trigger 175, the struts 173b1 of the second portion 173b are configured to radial expand or collapse. By controlling the extent of radial expansion and collapse of the struts 173b1 of the expansion member 173, the trigger 175 controls the height (i.e., a distance between the outer surfaces of the first body 110 and the second body 130) of the implant 100.
[56] For example, in response to the rotation of the trigger 175 in the clockwise direction (i.e., towards the head 171a), the struts 173b1 are configured to expand radially. This is due to the third portion 173c being pushed towards the first portion 173a when the trigger 175 is rotated in the clockwise direction. The movement of the third portion 173c towards the first portion 173a introduces a tension in the struts 173b1 of the second portion 173b, thereby causing radial expansion of the struts 173b1. Expansion of the struts 173b1 forces the resilient connectors 151 to expand. As a result, the first body 110 and the second body 130 move apart from each other introducing a gap therebetween. Thus, the implant 100 expands.
[57] Similarly, in response to the rotation of the of the trigger 175 in the anticlockwise direction (i.e., away from the head 171a), the struts 173b1 are configured to collapse. This is due to the third portion 173c moving away from the first portion 173a when the trigger 175 is rotated in the anticlockwise direction. The movement of the third portion 173c away from the first portion 173a releases the tension acting upon the struts 173b1 and the resilient connectors 151. This causes the struts 173b1 and resilient connectors 151 to collapse. As a result, the first body 110 and the second body 130 move closer to each other. Thus, the implant 100 collapses or the height (i.e., a distance between the outer surfaces of the first body 110 and the second body 130) of the implant 100 reduces.
[58] Fig. 4 depicts an exemplary method 400 to expand the implant 100. Before commencing the method 400, optionally, the implant 100 may be placed in one of an intervertebral space of the spine.
[59] At step 401, the trigger 175 of the expandable assembly 170 is rotatably pushed towards the head 171a of the mounting member 171. In an exemplary embodiment, the trigger 175 is rotated in the clockwise direction. The plurality of internal threads of the trigger 175 engages with the plurality of external threads 171c provided on the shank 171b of the mounting member 171, thereby rotatably moving the trigger 175 towards the head 171a.
[60] At step 403, the third portion 173c of the expansion member 173 is pushed towards the first portion 173a of the expansion member 173. The movement of the third portion 173c towards the first portion 173a corresponds to the movement of the trigger 175 on the shank 171b of the mounting member 171.
[61] At step 405, in response to the movement of the third portion 173c towards the first portion 173a, the struts 173b1 of the second portion 173b expand radially.
[62] At step 407, the expansion of the struts 173b1 causes the first body 110 and the second body 130 to move apart from each other. As a result, the gap there between is increased. Consequently, an overall height of the implant 100 is increased. In an exemplary embodiment, the increase in height of the implant 100 is directly proportional to the change in position of the trigger 175 (and/or the third portion 173c of the expansion member 173) with respect to the shank 171b of the mounting member 171.
[63] Fig. 5 depicts an exemplary method 500 to collapse the implant 100. The method commences at step 501 where the trigger 175 of the expandable assembly 170 is moved away from the head 171a by rotating the trigger 175 in the anti-clockwise direction. The plurality of internal threads of the trigger 175 mates with the plurality of external threads 171c on the shank 171b, thereby rotatably moving the trigger 175 away from the head 171a.
[64] At step 503, the struts 173b1 of the second portion 173b radially collapses.
[65] At step 505, in response to the collapse of the struts 173b1, the third portion 173c moves away from the first portion 173a, i.e., towards the second end 100b of the implant 100.
[66] At step 507, the collapse of the struts 173b1 causes the first body 110 and the second body 130 to move towards each other. This is due to the biasness of the resilient connectors 151 to remain in un-stretched condition. As a result, the gap between the first body 110 and the second body 130 is decreased. Consequently, the overall height of the implant 100 is decreased. In an exemplary embodiment, the decrease in the height of the implant 100 is directly proportional to the change in position of the trigger 175 (and/or the third portion 173c of the expansion member 173) with respect to the shank 171b of the mounting member 171.
[67] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM:
1. An implant (100) having a first end (100a) and a second end (100b), the implant (100) comprising:
a. a first body (110) having an outer surface and an inner surface;
b. a second body (130) in close proximity to the first body (110), the second body (130) having an outer surface and an inner surface;
c. at least one set of resilient connectors (151) coupling the first body (110) to the second body (130), the resilient connectors (151) disposed on at least one end of the first body (110) and the second body (130);
d. an expandable assembly (170) at least partially disposed between the first body (110) and the second body (130), the expandable assembly (170) including a triggering mechanism and an expansion member (173),
wherein the expansion member (173) is configured to one of expand or collapse a gap between the first body (110) and the second body (130) upon receiving a trigger from the triggering mechanism; and
wherein the resilient connectors (151) are configured to recalibrate corresponding to the gap leading to change in height of the implant (100).
2. The implant (100) as claimed in claim 1, wherein at least one of the outer surface and the inner surface of the at least one first body (110) and the second body (130), at the first end (100a) and the second end (100b), is provided with at least one of a beveled edge, a chamfered edge, a fillet edge, or a combination thereof.
3. The implant (100) as claimed in claim 1, wherein at least one of the outer surface of the first body (110) and the second body (130) are provided with a plurality of ridges (111).
4. The implant (100) as claimed in claim 1, wherein an inner surface of the first body (110) is provided with a groove (115) that extends from the first end (100a) to the second end (100b) and is configured to at least partially enclose a portion of the expandable assembly (170).
5. The implant (100) as claimed in claim 4, wherein the groove (115) is in fluid communication with at least one hole (113) of the first body (110) and the second body (120), wherein the at least one hole (113) extends from the outer surface to the inner surface of at least one of the first body 110 and the second body (120).
6. The implant (100) as claimed in claim 1, wherein the resilient connectors (151) are movable between an at least partially stretched position and an unstretched position by changing its structural conformation depending upon the gap between the first body (110) and the second body (130), thereby recalibrating the resilient connectors (151).
7. The implant (100) as claimed in claim 6, wherein the resilient connectors (151) may be at least one of a self-expandable material, spring or foam.
8. The implant (100) as claimed in claim 1, wherein the triggering mechanism includes a mounting member (171) having;
a. a head (171a) configured to restrict relative motion of the mounting member (171) with respect to the first body (110), and the second body (130);
b. a shank (171b) having a first end coupled to the head (171a) and a second end provided with a plurality of external threads (171c) extending at least partially along its length, and;
c. a trigger (175) having a plurality of internal threads extending at least partially along its length.
9. The implant (100) as claimed in claim 8, wherein upon mating of the plurality of internal threads of the trigger (175) with the plurality of external threads (171c) of the shank (171b), the trigger (175) is configured to rotate backward along at least a portion of the length of the shank (171b), in a clockwise direction.
10. The implant (100) as claimed in claim 1, wherein the expansion member (173) includes
a. a first portion (173a) having a first lumen configured to receive the shank (171b) of the mounting member (171);
b. a third portion (173c) configured to receive a trigger (175);
c. a second portion (173b) sandwiched between the first portion (173a) and third portion (173c), the second portion (173b) configured to expand radially;
wherein, in response to rotation of the trigger (175) towards the head (171a), the second portion (173b) of the expansion member (173) is configured to expand, causing the first body (110) and the second body (130) to move apart, resulting in the increased gap between therebetween, thereby expanding the implant (100);
wherein, in response to rotation of the trigger (175) away from the head (171a), the second portion (173b) of the expansion member (173) is configured to collapse, causing the first body (110) and the second body (130) to move closer to each other.
11. The implant (100) as claimed in claim 10, wherein the second portion (173b) may be at least one of a strut or an inflatable balloon.