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:
REALIGNMENT DEVICE
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] This present disclosure relates to a medical device. More particularly, the present disclosure relates to a realignment device.
BACKGROUND OF INVENTION
[2] Spine forms an important bone structure of a human body. Spine supports thoracic cavity, and gives a structure to the body. It is essential for maintaining posture of the body, walking, twisting and moving. Spine is made up of vertebrae (bones), disks, joints, soft tissues, nerves and spinal cord. Deformity of spine includes deviation in spinal curvature or alignment from normal limits. Deformities of spine causes great discomfort to the patients due to loss of posture, unbearable pain and at times loss of mobility.
[3] The deformities of spine generally include kyphosis, scoliosis, spondylolisthesis etc. These deformities generally need corrective surgeries which can range from being minimally invasive to being highly complex. Different devices are implanted for realigning the curvature of the spine.
[4] Conventional devices for spine realignment do not provide a high degree of movement after implantation and fail to conform to the growing vertebrae after a period of time. Further, the conventional devices include bearings that are prone to failure and require periodic lubrication.
[5] Thus, there arises a need for a new realignment device that overcomes the drawbacks of the conventional devices.
SUMMARY OF INVENTION
[6] 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.
[7] The present disclosure relates to a device including a connector, a first elongate member, and a second elongate member. The connector has a first lumen and a second lumen. The first lumen includes at least a first portion, and a second portion. An internal diameter of the second portion is more than an internal diameter of the first portion. The first elongate member is slidably coupled to the connector. The first elongate member extends between a first end and a second end. The first elongate member is disposed at least partially within the first lumen of the connector. The first elongate member includes at least one flange, and a resilient member. The at least one flange is disposed on an outer surface of the first elongate member at a pre-defined distance from the connector. The resilient member is disposed around at least a portion of the first elongate member. The resilient member has a third end disposed towards the connector and a fourth end coupled to the at least one flange. The resilient member is at least partially disposed within the second portion of the first lumen. The second elongate member is at least partially disposed within the second lumen of the connector.
BRIEF DESCRIPTION OF DRAWINGS
[8] 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.
[9] Fig. 1 depicts a device 100 according to an exemplary embodiment of the present disclosure.
[10] Fig. 1a depicts a cross sectional view of a first elongate member 110 along with a connector 130 according to an exemplary embodiment of the present disclosure.
[11] Fig. 2 depicts a cross-sectional view of the connector 130 according to an exemplary embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[12] 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.
[13] 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.
[14] 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.
[15] 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.
[16] This present disclosure relates to a realignment device (or device). The device is implanted over the vertebrae to correct spinal deformity.
[17] The device of the present disclosure provides stability to the spine, which is essential for fusion and healing. The device can be customized basis the anatomy of the spine thereby catering to diverse anatomies of spine deformities and patients. The device can easily withstand the forces exerted by the spine without compromising in mobility. The device is light weight and easy to implant. The device of the present disclosure does not require any bearing nor does it require any lubrication.
[18] Now referring to the figures, Fig. 1 depicts an exemplary embodiment of a device 100. The device 100 includes a plurality of components operationally coupled to each other. The plurality of components includes, without limitation, at least two elongate members coupled to each other via a connector 130. In an exemplary embodiment, the device 100 includes two elongate members, namely, a first elongate member 110 and a second elongate member 120.
[19] The connector 130 is slidably coupled to at least one of the first elongate member 110 and the second elongate member 120. In an exemplary embodiment, the connector 130 is slidably coupled to the first elongate member 110 and fixedly coupled to the second elongate member 120.
[20] The first elongate member 110 extends between a first end 110a and a second end 110b thereby defining a predefined length depending on the bone anatomy of the patient. The first elongate member 110 has a pre-defined diameter depending on the bone anatomy of the patient. The first elongate member 110 is made of a material including, but not limited to, titanium alloy, precipitation hardened stainless steel, etc. In an exemplary embodiment, the first elongate member 110 is made of titanium alloy. The first elongate member 110 may have a pre-defined lateral cross-sectional shape including, but not limited to, circular, triangular, square, etc. In an exemplary embodiment, the first elongate member 110 has a triangular lateral cross-section shape. In an alternate embodiment, the first elongate member 110 has a cylindrical lateral cross-section shape.
[21] The first end 110a is a free end. The connector 130 may slidably pass over the first end 110a of the first elongate member 110, thereby coupling the first elongate member 110 to the connector 130 (described later).
[22] The second end 110b may be coupled to a bone, for example, a vertebra of the spine. The second end 110b is provided with at least one coupling member 111. In an exemplary embodiment, the second end 110b is coupled to a vertebra of the spine towards the bottom end of the spine with the help of two coupling members 111.
[23] The coupling member 111 includes a hub 111a and at least one fastener 111b. The hub 111a helps to couple the fastener 111b to the first elongate member 110. The medical practitioner uses the fastener 111b to couple the first elongate member 110 to the bone.
[24] Although the coupling member 111 is described with the example of the hub 111a and fasteners 111b, other functionally equivalent techniques may be used to couple the first elongate member 110 to the bone and the same is within the scope of the teachings of the present disclosure.
[25] The first elongate member 110 is provided with at least one flange 113 disposed around an outer surface of the first elongate member 110. In an exemplary embodiment, as shown in Fig. 1, the first elongate member 110 is provided with one flange 113. The flange 113 is disposed at a pre-defined distance from the connector 130. The pre-defined distance depends upon the bone anatomy of the patient. The flange 113 is either fixedly or slidably coupled to the outer surface of the first elongate member 110. In an exemplary embodiment, the flange 113 is fixedly coupled to the first elongate member 110.
[26] In an alternate embodiment, the flange 113 is slidably coupled to the first elongate member 110 thereby allowing the medical practitioner to adjust a relative position of the connector 130 over the first elongate member 110 according to an anatomy of the spine. Once the flange 113 is slidably positioned around the first elongate member 110, the flange 113 may be coupled to the first elongate member 110 via one or more fasteners (not shown). Other functionally equivalent techniques to couple the flange 113 around the first elongate member 110 are within the scope of the teachings of the present disclosure.
[27] A resilient member 115 is disposed around at least a portion of the first elongate member 110. In an exemplary embodiment, as shown in Fig. 1, the resilient member 115 is disposed between the flange 113 and the connector 130. The resilient member 115 has a third end 115a and a fourth end 115b. The third end 115a is either fixedly or removably coupled to at least a portion of the connector 130 (described later).
[28] The fourth end 115b is either fixedly or removably coupled to the flange 113. In an exemplary embodiment, the fourth end 115b is fixedly coupled to the flange 113.
[29] The second elongate member 120 extends between a fifth end 120a and a sixth end 120b thereby defining a predefined length depending on the bone anatomy of the patient. The second elongate member 120 has a pre-defined diameter depending on the bone anatomy of the patient. The second elongate member 120 is made of a material including, but not limited to, titanium alloy, precipitation hardened stainless steel, etc. In an exemplary embodiment, the second elongate member 120 is made of titanium alloy. The second elongate member 120 may have a pre-defined lateral cross-sectional shape, including but not limited to, circular, triangular, square, etc. In an exemplary embodiment, the second elongate member 120 has a triangular lateral cross-section shape. In an alternate embodiment, the second elongate member 120 has a cylindrical lateral cross-section shape.
[30] The fifth end 120a may be coupled to a bone, for example, a vertebra of the spine. The fifth end 120a is provided with at least one coupling member 111. In an exemplary embodiment, the fifth end 120a is coupled to a vertebra of the spine towards the top end of the spine with the help of two coupling members 111.
[31] Although the coupling member 111 is described with the example of the hub 111a and fasteners 111b, other functionally equivalent techniques may be used to couple the second elongate member 120 to the bone and the same is within the scope of the teachings of the present disclosure.
[32] The sixth end 120b is a free end. The connector 130 may be fixedly coupled to the second elongate member 120, adjacent to the sixth end 120b. In an exemplary embodiment, as shown in Fig. 1, the connector 130 is fixedly coupled to the second elongate member 120 via a fastener 133a. Other functionally equivalent techniques to couple the connector 130 to the second elongate member 120 are within the scope of the teachings of the present disclosure.
[33] Although the second elongate member 120 of the present disclosure is described as fixedly coupled to the connector 130, the second elongate member 120 may be slidably coupled to the connector 130 (similar to the first elongate member 110) and the same is within the scope of the teachings of the present disclosure.
[34] The connector 130 may be made of a pre-defined material including, but not limited to, titanium alloy, CoCr, PEEK polymer, etc. In an exemplary embodiment, the connector 130 is made of titanium alloy. The connector 130 may have a pre-defined shape including, but not limited to, triangular, square, etc. In an exemplary embodiment, as shown in Fig. 1a, the connector 130 is triangular.
[35] The connector 130 includes at least two lumens. The number of lumens depend upon the number of elongate members of the device 100. In an exemplary embodiment, the connector 130 is provided with two lumens, i.e., a first lumen 131 (as shown in Fig. 1a) and a second lumen (not shown). The first lumen 131 is configured to slidably receive at least a portion of the first elongate member 110 (as shown in Fig. 1a). The second lumen is configured to at least partially receive the second elongate member 120. Accordingly, the first lumen 131 may have a shape corresponding to the lateral cross-sectional shape of the first elongate member 110 and the second lumen may have a shape corresponding to the lateral cross-sectional shape of the second elongate member 120. In an exemplary embodiment, the first lumen 131 and the second lumen has a triangular lateral cross-section shape.
[36] A cross sectional view of the connector 130 depicting the first lumen 131 and the first elongate member 110 is shown in Fig. 1a. At least a portion of the first elongate member 110 and at least a portion of the resilient member 115 is disposed within the first lumen 131.
[37] Fig. 2 depicts the cross-sectional view of the connector 130 along with the first lumen 131 without the first elongate member 110 and the resilient member 115. The first lumen 131 includes at least a first portion 131a and a second portion 131b. The first portion 131a has an internal diameter that is less than an internal diameter of the second portion 131b. The internal diameter of the first portion 131a is more than the diameter of the first elongate member 110.The first portion 131a may have a lateral cross-sectional shape corresponding to the first lumen131. In an exemplary embodiment, the first portion 131a has a triangular lateral cross-sectional shape.
[38] In an exemplary embodiment, the first portion 131a of the first lumen 131 corresponds to a tubular structure fixedly coupled to an inner surface of the first lumen 131 with the help of a fastener 133b (as shown in Fig. 1). Other functionally equivalent techniques to couple the tubular structure within the first lumen 131 are within the scope of the teachings of the present disclosure. In an alternate embodiment, the first portion 131a is defined by carving out a portion of an inner surface of the first lumen 131 to make the second portion 131b.
[39] An inner surface of the first portion 131a is provided with a plurality of cavities 131a1 (as shown in Fig. 2). In an exemplary embodiment, as shown in Fig. 2, the first portion 131a is provided with four cavities 131a1. The number of cavities 131a1 varies according to the size of the connector 130, which varies depending on the bone anatomy. The number of cavities 131a1 may also vary according to the need of the user and/or the manufacturing capability. Each of the cavities 131a1 is provided with one ball 131a2 (as shown in Fig. 1a). The balls 131a2 are made of a pre-defined material including, but not limited to, precipitation hardened stainless steel, titanium, CoCr, etc. In an exemplary embodiment, the balls 131a2 are made of precipitation hardened stainless steel. The balls 131a2 are configured to freely rotate in any direction within the cavity 131a1.
[40] The balls 131a2, at least partially, protrude out from their respective cavities 131a1 such that the balls 131a2 glide over the outer surface of the first elongate member 110. The balls 131a2 facilitate easy axial as well as rotational motion of the first elongate member 110 with respect to the connector 130, thereby giving freedom of mobility to the spine on which the device 100 is implanted over.
[41] As shown in Fig. 1a, the resilient member 115 is at least partially disposed within the second portion 131b such that the third end 115a of the resilient member 115 is coupled either fixedly or removably to an end of the first portion 131a of the first lumen 131. In an exemplary embodiment, the third end 115a of the resilient member 115 is removably coupled to the end of the first portion 131a of the first lumen 131. Thus, the resilient member 115 is coupled to and disposed between the first portion 131a of the first lumen 131 and the flange 113. The internal diameter of the second portion 131b is such that the second portion131b can accommodate the first elongate member 110 along with the resilient member 115. The resilient member 115 provides tension and stability to the movement of the first elongate member 110 with respect to the connector 130.
[42] 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) comprising:
a. a connector (130) having a first lumen (131) and a second lumen, the first lumen (131) including at least:
i. a first portion (131a), and
ii. a second portion (131b), an internal diameter of the second portion (131b) being more than an internal diameter of the first portion (131a);
b. a first elongate member (110) slidably coupled to the connector (130) and extending between a first end (110a) and a second end (110b), the first elongate member (110) disposed at least partially within the first lumen (131) of the connector (130), the first elongate member (110) including:
i. at least one flange (113) disposed on an outer surface of the first elongate member (110) at a pre-defined distance from the connector (130), and
ii. a resilient member (115) is disposed around at least a portion of the first elongate member (110), the resilient member (115) having a third end (115a) disposed towards the connector (130) and a fourth end (115b) coupled to the at least one flange (113), the resilient member (115) is at least partially disposed within the second portion (131b) of the first lumen (131); and
c. a second elongate member (120) at least partially disposed within the second lumen of the connector (130).
2. The device (100) as claimed in claim 1, wherein the flange (113) is either fixedly or slidably coupled to the outer surface of the first elongate member (110).
3. The device (100) as claimed in claim 1, wherein the second elongate member (120) is either fixedly or slidably coupled to the connector (130).
4. The device (100) as claimed in claim 1, wherein the internal diameter of the first portion (131a) is more than a diameter of the first elongate member (110).
5. The device (100) as claimed in claim 1, wherein the second portion (131b) accommodates the first elongate member (110) along with the resilient member (115).
6. The device (100) as claimed in claim 1, wherein the first portion (131a) of the first lumen (131) includes a tubular structure fixedly coupled to an inner surface of the first lumen (131).
7. The device (100) as claimed in claim 1, wherein an inner surface of the first portion (131a) is provided with a plurality of cavities (131a1) provided with one ball (131a2) each.
8. The device (100) as claimed in claim 7, wherein the third end (115a) of the resilient member (115) is coupled to an end of the first portion (131a) of the first lumen (131).
9. The device (100) as claimed in claim 1, wherein at least one of the second end (110b) of the first elongate member (110) and a fifth end (120a) of the second elongate member (120) is provided with at least one coupling member (111) each.
10. The device (100) as claimed in claim 9, wherein each coupling member (111) includes a hub (111a) and at least one fastener (111b).
11. The device (100) as claimed in claim 1, wherein at least one of the first lumen (131) or the second lumen has a triangular lateral cross-section.
12. The device (100) as claimed in claim 1, wherein the connector (130) is triangular.
13. The device (100) as claimed in claim 1, wherein the first portion (131a) has a triangular lateral cross-section.