Description:TECHNICAL FIELD
[1] The present disclosure relates to a leaflet fixation device. Moreover, the present disclosure relates to a deployment device. Furthermore, the present disclosure relates to a method for deploying the leaflet fixation device.
BACKGROUND OF THE INVENTION
[2] Typically, a bicuspid valve, also known as the mitral valve, is one of the four valves in the heart of a mammal, that is located between left atrium and left ventricle of the heart. The bicuspid valve has two cusps or leaflets, which are flap-like structures that open and close to control the flow of blood from the left atrium and the left ventricle. However, regurgitation (i.e., reverse flow of the blood in the left atrium) is commonly noticed at a site of the bicuspid valve.

[3] Conventional devices are structurally complex and their introduction and deployment at a target site, namely, the bicuspid valve, is time intensive. Moreover, a number of individual switching of the implantable device as well as its corresponding deployment device is required to proper place the device at the target site as a result of complex structure of the conventional devices, making the device less user-friendly.

[4] Therefore, in the light of foregoing discussion, there exists a need to overcome the aforementioned drawbacks.
SUMMARY OF THE INVENTION
[5] A primary objective of the present disclosure seeks to provide a leaflet fixation device that prevents or reduces regurgitation of left atrium at bicuspid valve site in heart. Another primary objective of the present disclosure seeks to provide a deployment device for deploying the leaflet fixation device at a target site, namely, the mitral valve. Yet another primary objective of the present disclosure seeks to provide a method for deploying the leaflet fixation device. An aim of the present disclosure is to provide a solution that overcomes at least partially the problems encountered in prior art.

[6] In a first aspect, an embodiment of the present disclosure provides a leaflet fixation device comprising an elongate support body comprising a plurality of spikes arranged at least partially along a length of the elongate support body. Moreover, the leaflet fixation device comprises a clip comprising a first arm and a second arm arranged on either side of the elongate support body, wherein, when in use, the first arm and a first side of the elongate support body are adapted to receive, via distal ends thereof, a first leaflet therein, and the second arm and a second side of the elongate support body are adapted to receive, via distal ends thereof, a second leaflet therein. Furthermore, the leaflet fixation device comprises a coupling means comprising a first gripper coupled to the first arm of the clip, a second gripper coupled to the second arm of the clip, and a pivot point adapted to moveably couple the first gripper and the second gripper, and fix thereto a proximal end of the elongate support body. A coordinated movement of the first gripper and the second gripper around the pivot point allows the first arm and the second arm to move between an open configuration of the leaflet fixation device comprising a first tension between the first gripper and the second gripper resulting in the first arm and the second arm being angular to the elongate support body, and a closed configuration of the leaflet fixation device comprising a second tension between the first gripper and the second gripper resulting in the first arm and the second arm being parallel to the elongate support body, wherein the second tension is lower than the first tension, Moreover, the leaflet fixation device moves from the open configuration to the closed configuration to clip the first leaflet and the second leaflet between the elongate support body and the first arm and the second arm, respectively, when in use.
[7] The aforementioned leaflet fixation device of the first aspect is able to effectively clip onto and release the first leaflet and the second leaflet as required, i.e., alternatively or together, due to the coordinated movement of the first gripper and the second gripper to move between the open configuration and close configuration. Beneficially, the first arm and the second arm are operated and controlled using a single pivot point, thereby making the deployment of the leaflet fixation device at a target site easy and timesaving. Moreover, the movement between the open configuration and the close configuration enables the leaflet fixation device to effectively reduce regurgitation in left atrium of heart.

[8] In a second aspect, an embodiment of the present disclosure provides a deployment device for deploying the leaflet fixation device of the aforementioned first aspect, the deployment device comprising: a handle adapted to enable a user to hold the deployment device; a detachment jaw adapted to hold and release the pivot point of the leaflet fixation device in a closed configuration and an open configuration thereof, respectively; a detachment rod adapted to operably couple the detachment jaw to the handle; a deployment switch arranged in the handle, wherein the deployment switch is adapted to move the detachment jaw between the closed configuration and the open configuration; a first actuating jaw adapted to hold and release the first arm of the leaflet fixation device in a closed configuration and an open configuration thereof, respectively; a first actuating rod adapted to operably couple the first actuating jaw to the handle; a first actuating switch arranged in the handle, wherein the first actuating switch is adapted to move the first actuating jaw between the closed configuration and the open configuration; a second actuating jaw adapted to hold and release the second arm of the leaflet fixation device in a closed configuration and an open configuration thereof, respectively; a second actuating rod adapted to operably couple the second actuating jaw to the handle; a second actuating switch arranged in the handle, wherein the second actuating switch is adapted to move the second actuating jaw between the closed configuration and the open configuration; and a deployment tube adapted to house the detachment rod, the first actuating rod, and the second actuating rod. When in use: the first actuating switch is adapted to: receive a push to move the first actuating jaw from the open configuration to the closed configuration, and when the a leaflet is received between the first arm and the first side of an elongate support body of the leaflet fixation device, receive a pull to move the first actuating jaw from the closed configuration to the open configuration; and the second actuating switch is adapted to: receive a push to move the second actuating jaw from the open configuration to the closed configuration, and when a second leaflet is received between the second arm and the second side of the elongate support body of the leaflet fixation device, receive a pull to move the second actuating jaw from the closed configuration to the open configuration, and when the first actuating switch and the second actuating switch receives the pull, the deployment switch is adapted to receive a pull to move the detachment jaw from the closed configuration to the open configuration to release the pivot point of the leaflet fixation device and deploy the leaflet fixation device.

[9] The aforementioned deployment device of the second aspect is able to effectively receive, between first and second actuating jaws thereof, the leaflet fixation device of the first aspect, to enable it to clip onto and release the first leaflet and the second leaflet as required, i.e., alternatively or together, due to the coordinated movement of the first gripper and the second gripper to move between the open configuration and close configuration as mediated by the aforementioned deployment device. Beneficially, the deployment device is retractable and repositionable, and the procedure timing is less. Additionally, the deployment device is user friendly, and adapted for less switching for proper placement or deployment of the leaflet fixation device at a target site, easily and in less time. Moreover, the deployment device introduces the leaflet fixation device at the target side using a minimally invasive transapical approach, through a small incision made in the chest, typically between the ribs, and then directly through the apex (the pointed end) of the left ventricle.

[10] In a third aspect, an embodiment of the present disclosure provides a method for deploying the leaflet fixation device of the aforementioned first aspect, the method comprising: engaging the leaflet fixation device with a deployment device; receiving a push at a first actuating switch of the deployment device for moving a first actuating jaw of the deployment device from an open configuration to a closed configuration thereof, wherein the first actuating jaw is adapted to hold and release the first arm of the leaflet fixation device in the closed configuration and the open configuration, respectively, when the first leaflet is received between the first arm and the first side of the elongate support body of the leaflet fixation device, receiving a pull at the first actuating switch of the deployment device for moving the first actuating jaw of the deployment device from the closed configuration to the open configuration, receiving a push at a second actuating switch of the deployment device for moving a second actuating jaw of the deployment device from an open configuration to a closed configuration thereof, wherein the second actuating jaw is adapted to hold and release the second arm of the leaflet fixation device in the closed configuration and the open configuration, respectively, when the second leaflet is received between the second arm and the second side of the elongate support body of the leaflet fixation device, receiving a pull at the second actuating switch of the deployment device for moving the second actuating jaw of the deployment device from the closed configuration to the open configuration, and when the first actuating switch and the second actuating switch receives the pull, receiving a pull at a deployment switch of the deployment device for moving a detachment jaw of the deployment device from a closed configuration to an open configuration thereof for releasing a pivot point of the leaflet fixation device and deploying the leaflet fixation device.
[11] The aforementioned method of the third aspect is able to effectively deploy the leaflet fixation device of the first aspect using the deployment device of the second aspect. The aforementioned method achieves all the advantages and technical effects of the leaflet fixation device and the deployment device of effectively reducing regurgitation in left atrium of heart of the present disclosure. The use of the aforementioned method contributes to deploying the leaflet fixation device via a minimally invasive transapical approach, through a small incision made in the chest, typically between the ribs, and then directly through the apex (the pointed end) of the left ventricle. The use of the aforementioned method also contributes to significantly enhance patient outcomes, curtail healthcare expenses, and elevate the overall quality of life for those afflicted by regurgitation in left atrium of heart.

[12] Embodiments of the present disclosure substantially eliminate or at least partially address the aforementioned problems in the prior art, and enable assignment of the new user into a cluster for which the personalised content is already available in the metaverse, thereby minimizing time and efforts for customising each object individually according to the new user.

[13] Additional aspects, advantages, features and objects of the present disclosure would be made apparent from the drawings and the detailed description of the illustrative embodiments construed in conjunction with the appended claims that follow.

[14] It will be appreciated that features of the present disclosure are susceptible to being combined in various combinations without departing from the scope of the present disclosure as defined by the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[15] The summary above, as well as the following detailed description of embodiments, is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the present disclosure is not limited to specific instrumentalities disclosed herein. Moreover, those skilled in the art will understand that the drawings are not to scale.

[16] Embodiments of the present disclosure will now be described, by way of example only, with reference to the following diagrams wherein:
FIGs. 1A and 1B illustrate perspective views of a leaflet fixation device in an open configuration and a closed configuration, respectively, in accordance with an embodiment of the present disclosure;
FIGs. 1C and 1D illustrate front views of the leaflet fixation device in the open configuration and the closed configuration, respectively, in accordance with an embodiment of the present disclosure;
FIGs. 2A and 2B illustrate schematic illustrations of an open configuration and a closed configuration of a leaflet fixation device, in use, with respect to a first leaflet and a second leaflet, respectively, in accordance with an embodiment of the present disclosure;
FIG. 3A illustrates a schematic illustration of a deployment device for deploying the leaflet fixation device of FIG. 1, in accordance with an embodiment of the present disclosure;
FIG. 3B illustrates a perspective view of the handle and a sheath of the deployment device of FIG. 3A, in accordance with an embodiment of the present disclosure;
FIG. 3C illustrates an exploded view of the deployment device of FIG. 3A, in accordance with an embodiment of the present disclosure;
FIG. 4 illustrates the deployment device of FIG. 3A for deploying the leaflet fixation device of FIG. 1A, when in use, in accordance with the embodiment of the present disclosure;
FIG. 5 illustrates the deployment device of FIG. 3A for deploying the leaflet fixation device of FIG. 1A, when in use, in accordance with the embodiment of the present disclosure;
FIG. 6 illustrates a schematic illustration of a deployment device for deploying the leaflet fixation device of FIG. 1A, in accordance with another embodiment of the present disclosure;
FIG. 7 illustrates a schematic illustration of steps of a method to deploy a leaflet fixation device of FIG. 1A at targeted site, using a deployment device of FIG. 3A, in accordance with an embodiment of the present disclosure; and
FIG. 8 illustrates a schematic illustration of steps of a method for deploying a leaflet fixation device at targeted site, using the deployment device, in accordance with an embodiment of the present disclosure.
[17] In the accompanying drawings, an underlined number is employed to represent an item over which the underlined number is positioned or an item to which the underlined number is adjacent. A non-underlined number relates to an item identified by a line linking the non-underlined number to the item. When a number is non-underlined and accompanied by an associated arrow, the non-underlined number is used to identify a general item at which the arrow is pointing.
DETAILED DESCRIPTION OF EMBODIMENTS
[18] The following detailed description illustrates embodiments of the present disclosure and ways in which they can be implemented. Although some modes of carrying out the present disclosure have been disclosed, those skilled in the art would recognize that other embodiments for carrying out or practising the present disclosure are also possible.

[19] Referring to FIGs. 1A-D, illustrated are perspective views (FIGs. 1A and 1B) of a leaflet fixation device 100 in an open configuration 102 and a closed configuration 104, respectively; and front views (FIGs. 1C and 1D) of the leaflet fixation device 100 in the open configuration 102 and the closed configuration 104, respectively, in accordance with an embodiment of the present disclosure. As shown, the leaflet fixation device 100 comprises an elongate support body 106 comprising a plurality of spikes (depicted as a first spike 108A and a second spike 108B) arranged at least partially along a length of the elongate support body 106. Moreover, the leaflet fixation device 100 comprises a clip 110 comprising a first arm 112 and a second arm 114 arranged on either side of the elongate support body 106, wherein, when in use, the first arm 112 and a first side of the elongate support body 106 are adapted to receive, via distal ends thereof, a first leaflet therein, and the second arm 114 and a second side of the elongate support body 106 are adapted to receive, via distal ends thereof, a second leaflet therein. Furthermore, the leaflet fixation device 100 comprises a coupling means 116 comprising a first gripper 118 coupled to the first arm of the clip, a second gripper 120 coupled to the second arm of the clip, and a pivot point 122 adapted to moveably couple the first gripper 118 and the second gripper 120, and fix thereto a proximal end of the elongate support body; and wherein, a coordinated movement of the first gripper 118 and the second gripper 120 around the pivot point 122 allows the first arm 112 and the second arm 114 to move between the open configuration 102 of the leaflet fixation device 100 comprising a first tension between the first gripper 118 and the second gripper 120 resulting in the first arm 112 and the second arm 114 being angular to the elongate support body 106, and a closed configuration 104 of the leaflet fixation device 100 comprising a second tension between the first gripper 118 and the second gripper 120 resulting in the first arm 112 and the second arm 114 being parallel to the elongate support body 106, wherein the second tension is lower than the first tension, and wherein the leaflet fixation device 100 moves from the open configuration 102 to the closed configuration 104 to clip the first leaflet and the second leaflet between the elongate support body 106 and the first arm 112 and the second arm 114, respectively, when in use.

[20] In an embodiment, the leaflet is a bicuspid valve leaflet of a mammalian heart. In this regard, the term "mammalian heart" refers to a heart of a mammal. Herein, the term "bicuspid valve leaflet" refers to a valve located between the left atrium and left ventricle of the mammalian heart, having two leaflets which the first leaflet and the second leaflet. The bicuspid valve leaflet is responsible for controlling the flow of blood from the left atrium to the left ventricle. Typically, flow of blood between left atrium (LA) and left ventricle (LV) is a crucial part of the heart's function in circulating oxygenated blood throughout the body. Oxygenated blood returns from the lungs via the pulmonary veins and enters the LA, thereby, increasing the pressure within the LA. The pressure pushes open the bicuspid or mitral valve, which separates the left atrium from the left ventricle to allow the blood to flow from the LA into the LV. Once the LV is filled with blood, it contracts (during the systole phase of the cardiac cycle), increasing the pressure in the LV, forcing the bicuspid or mitral valve to close and preventing the backflow of blood into the LA, and eventually forcing the aortic valve to open, allowing the oxygenated blood to be ejected from the LV into the aorta and subsequently to the rest of the body. However, it is observed that in many individuals, the bicuspid or mitral valve fail to close resulting in regurgitation of LA, and often cardiac issues.

[21] Herein, the term "leaflet fixation device" refers to a device that is used for effectively closing of leaflets of left atrium (LA) in heart to prevent regurgitation of the left atrium. Notably, the leaflet fixation device 100 is used to hold onto the leaflets of the left atrium that enables the leaflet fixation device 100 to control the movement of oxygenated blood from the left atrium to flow into the left ventricle and further into aortic valve, preventing the backflow of the blood into the left atrium. In this regard, the leaflet fixation device is deployed at the target site, i.e., the bicuspid valve site, using a minimally invasive transapical approach. Herein, access to the left ventricle (LV) is achieved through an incision in the apex (tip) of the left ventricle, and the leaflet fixation device is deployed at the bicuspid valve site.

[22] Herein, the term "elongate support body" refers to a fixed elongated part having a predefined length for supporting or holding each of the leaflets of the bicuspid valve of left atrium. In this regard, the elongate support body 106 has the first side that is used to hold a first leaflet of the bicuspid valve, and the second side that is used to hold a second leaflet of the bicuspid valve. Optionally, the predefined length of the elongate support body 106 is in a range of 8 mm to 13 mm. Optionally, the predefined length of the elongate support body 106 is in a range of 8, 9, 10, 11 or 12 mm up to 9, 10, 11, 12 or 13 mm. In an example, the predefined length of the elongate support body 106 is 11 mm.

[23] Herein, the term "spike" refers to a protruding member that extends out of the elongate support body 106. The plurality of spikes, such as the first spike 108A and the second spike 108B, enables the elongate support body 106 to have a better grip on the leaflets of the bicuspid valve. Optionally, the plurality of spikes, such as the first spike 108A and the second spike 108B, are distributed uniformly along the length of the elongate support body 106 to ensure that the leaflets of the bicuspid valve are secured by the plurality of spikes, such as the first spike 108A and the second spike 108B, when the leaflet fixation device is in use.

[24] In an embodiment, the plurality of spikes, such as the first spike 108A and the second spike 108B arranged on the distal end of the elongate support body 106. In this regard, the distal end of the elongate support body 106 comprising the plurality of spikes ensures gripping the leaflets of the bicuspid valve against the moveable clip. Optionally, the plurality of spikes may be orthogonal or angular with respect to the length of the elongate support body 106.

[25] Herein, the term "clip" refers to a collective arrangement of the first arm 112 and the second arm 114 that closes to meet the elongate support body 106 to hold onto the leaflets of the left atrium. Herein, the term "first arm" refers to an elongate member facing the first side of the elongate support body 106 that moves away and towards the elongate support body 106 in between an open and closed configuration of the leaflet fixation device 100. Notably, when the first arm 112 is moved away from the elongate support body 106, a space is created between the first arm 112 and the elongate support body 106 is adapted to receive the first leaflet between the distal ends of the first arm 112 and the elongate support body 106. Herein, the term "second arm" refers to an elongate member facing the second side of the elongate support body 106 that moves away and towards the elongate support body 106. Notably, when the second arm 114 is moved away from the elongate support body 106, a space is created between the second arm 114 and the elongate support body 106 is adapted to receive the second leaflet between the distal ends of the second arm 114 and the elongate support body 106. In an embodiment, lengths of the first arm 112 and the second arm 114 are equal. Optionally, lengths of the first arm 112 and the second arm 114 are in a range of 10 mm – 15 mm. In an example, length of each of the first arm 112 and the second arm 114 is 13 mm. Optionally, lengths of the first arm 112 and the second arm 114 are longer by a range of 10-20% than the length of the elongate support body 106. Beneficially, the longer length of the first arm 112 and the second arm 114 ensure additional securing of the leaflets.

[26] In an embodiment, the leaflet fixation device 100 further comprises a slidable cover adapted to at least partially cover at least one of: the elongate support body 106, the first arm 112 of the clip 110, the second arm 114 of the clip 110. In this regard, the term "slidable cover" refers to a protective covering that can be slided onto any of: the elongate support body 106 and/or the first arm 112, the second arm 114. The slidable cover being adapted to at least partially cover at least one of the aforementioned elements (or components of the leaflet fixation device) implies that the at least one of the aforementioned elements are either completely or partially covered by the slidable cover. A technical effect of the at least one of: the elongate support body 106, the first arm 112 of the clip 110 and the second arm 114 of the clip 110 being at least partially covered by the slidable cover is that the at least one of: at least one of: the elongate support body 106, the first arm 112, the second arm 114 are effectively protected from external damage as well as it provides safety to the leaflets which are not damaged by spikes of friction between the elongate support body and the first arm and the second arm.

[27] In an embodiment, a fabrication material for: the elongate support body 106 is stainless steel; the clip 110 is selected from at least one of: nitinol, stainless steel; and the slidable cover is polyethylene terephthalate (PET). In this regard, the use of the stainless steel as the elongate support body 106 and the use of the at least one of: nitinol, stainless steel as the clip 110 and use of the polyethylene terephthalate (PET) as the slidable cover provides biocompatible and non-toxic heart valve prostheses.

[28] Herein, the term "coupling means" refers to a collective arrangement of the first gripper 118 and the second gripper 120 that enables to move the first arm 112 and the second arm 114 towards and away from the elongate support body 106. Herein, the term "first gripper" refers to an element coupled to the first arm 112 of the clip 110 to control the movement of the first arm 112. Notably, the first gripper 118 is coupled to the first arm 112 such that the movement of the first gripper 118 is inverse to the movement of the first arm 112. In other words, when the first gripper 118 moves towards an axis of the elongate support body 106, then the first arm 112 is caused to move away from the elongate support body 106, and vice versa. It will be appreciated that the first gripper 118 is moved towards the axis of the elongate support body 106 by applying force on the first gripper 118, while the first gripper 118 is moved away from the elongate support body 106 by releasing the first gripper 118. Herein, the term "second gripper" refers to an element coupled to the second arm 114 of the clip 110 to control the movement of the second arm 114. Notably, the second gripper 120 is coupled to the second arm 114 such that the movement of the second gripper 120 is inverse to the movement of the second arm 114. In other words, when the second gripper 120 moves towards an axis of the elongate support body 106, then the second arm 114 is caused to move away from the elongate support body 106, and vice versa. It will be appreciated that the second gripper 120 is moved towards the axis of the elongate support body 106 by applying force on the second gripper 120, while the second gripper 120 is moved away from the elongate support body 106 by releasing the second gripper 120. Herein, the term "pivot point" refers to an attachment point between the first and second grippers, whereat the proximal end of the elongate support body 106 is affixed. The pivot point 122 being movably coupled to the first gripper 118 and the second gripper 120 and enables the first gripper 118 and the second gripper 120 to rotate about the pivot point 122, causing the first gripper 118 and the second gripper 120 to move away and towards the axis of the elongate support body 106 thereby causing movement of the first arm and the second arm, respectively.

[29] In an embodiment, the first arm 112 and the second arm 114 angularly move withing a range of 5-75 degrees with respect to the elongate support body 106. Optionally, the first arm 112 and the second arm 114 angularly move within the range of 5, 10, 20, 30, 40, 50, 60, 70 up to 10, 20, 30, 40, 50, 60, 70, 75 degrees with respect to the elongate support body 106. Optionally, the first arm 112 and the second arm 114 angularly move up to 60 degrees with respect to the elongate support body 106. A technical effect of the first arm 112 and the second arm 114 being able to angularly move within the range of the 5-75 degrees with respect to the elongate support body 106 is that the first arm 112 and the second arm 114 are able to cover a wide range of motion away and towards the elongate support body 106, sufficient for an effective clipping the leaflets therebetween, as against the conventional devices which move over 90 degrees which is impractical and unnecessary for the desired task.

[30] Herein, the term "open configuration" refers to a configuration of the leaflet fixation device 100 in which the first arm 112 and the second arm 114 are angular to the elongate support body 106 which creates the space between the first arm 112 and the elongate support body 106 to receive the first leaflet therebetween, and the space between the second arm 114 and the elongate support body 106 to receive the second leaflet therebetween. Notably, the open configuration 102 of the leaflet fixation device 100 is achieved by exerting force on the first gripper 118 and the second gripper 122 towards each other which creates the first tension between the first gripper 118 and the second gripper 120 and subsequently, causing the first arm 112 and the second arm 114 to move away from each other and be angular to the elongate support body 106. The coordinated movement of the first gripper 118 and the second gripper 120 around the pivot point 122 implies that the first gripper 118 and the second gripper 120 are being made to move simultaneously in a coordinated manner around the pivot point 122.

[31] Herein, the term "closed configuration" refers to a configuration of the leaflet fixation device 100 in which the first arm 112 and the second arm 114 are at least partially parallel and closer to the elongate support body 106 which closes the space between the first arm 112 and the elongate support body 106 to clip the first leaflet therebetween, and the space between the second arm 114 and the elongate support body 106 to clip the second leaflet therebetween, when in use. It may be appreciated that when the leaflet fixation device is not in use or being introduced in the mammalian body, the leaflet fixation device is in the closed configuration. Notably, the closed configuration 104 of the leaflet fixation device 100 is achieved by releasing the first gripper 118 and the second gripper 122 which creates the second tension between the first gripper 118 and the second gripper 120 and subsequently, causing the first arm 112 and the second arm 114 to move towards each other and be parallel and closer to the elongate support body 106. Notably, the leaflet fixation device 100 is moved from the open configuration 102 to closed configuration 104 when being in use, i.e., as the first leaflet and the second leaflet are received between corresponding first and second sides of the elongate support body 106 and the first and second arms, respectively, and needs to be clipped during the use of the leaflet fixation device 100, for bringing the first leaflet and the second leaflet together for subsequently acting as valve to prevent the regurgitation of the left atrium in the heart.

[32] In an embodiment, the first tension and the second tension are implemented using a spring. In this regard, the term "spring" refers to a small, tightly coiled piece of metal, typically steel, which provides the necessary tension to hold the first gripper 118 and the second gripper 120 at the pivot point 122, wherein the first gripper 118 and the second gripper 120 have small grooves or holes where the ends of the spring are securely seated. Subsequently, the coordinated movement of the first gripper 118 and the second gripper 120 around the pivot point 122 towards each other causes the spring to compress which creates the first tension between the first gripper 120 and the second gripper 122. Likewise, the coordinated movement of the first gripper 118 and the second gripper 120 around the pivot point 122 away from each other causes the spring to relax which creates the second tension between the first gripper 120 and the second gripper 122. A technical effect of the first tension and the second tension being implemented using the spring is that a well-known and easy to implement means is used to effectively implement the first tension and the second tension for securing the leaflets by the leaflet fixation device.

[33] Optionally, the first tension is 0.5 - 10 N/mm and the second tension is 0.5 - 10 N/mm. Optionally, the first tension and the second tension are in a range from 0.5, 1, 1.5, 2, 4, 6 or 8 N/mm up to 1, 2, 4, 6, 8 or 10 N/mm. Optionally, the first tension and the second tension are same or different from each other.

[34] Moreover, the leaflet fixation device 100 further comprises a deployment device (as shown in FIG. 3) operable to deploy (or deliver) the leaflet fixation device 100 at a target site, wherein the deployment device is adapted to receive at least partially the first gripper 118 and the second gripper 120 therein, in the closed configuration 104 of leaflet fixation device 100, when not in use. In this regard, the term "target site" refers to a desired position near the heart where the leaflet fixation device 100 needs to be deployed to effectively control the movements of the leaflets of the bicuspid valve. Notably, the deployment device is adapted to control the switching of the first gripper 118 and the second gripper 120 to adjust the positioning of the leaflet fixation device 100 at the target site to receive the leaflets in corresponding spaces between the first arm 112 and second arm 114 and the elongate support body 106. A technical effect is that the position of the leaflet fixation device 100 is effective adjusted using the deployment device to accurately deploy the leaflet fixation device 100 at the target site and effectively secure the leaflets therein one at a time.

[35] In an embodiment, the deployment device is operable to control an opening of the elongate support body 106 and the first arm 112 to clip the first leaflet at a first time period and an opening of the elongate support body 106 and the second arm 114 to clip the second leaflet at a second time period, wherein the first time period is different from the second time period. Herein, the terms "first time period" and "second time period" are relative time period of securing the leaflets in corresponding spaces between the first arm 112 and second arm 114 and the elongate support body 106, respectively, one at a time. Notably, the first time period is followed by the second time period. Optionally, the difference between the first time period and the second time period is in a range of 30-180 seconds. Optionally, the difference between the first time period and the second time period is in a range from 30, 60, 90, 120 or 150 seconds up to 60, 90, 120, 150 or 180 seconds.

[36] Referring to FIGs. 2A-B, illustrated are schematic illustrations of an open configuration and a closed configuration of a leaflet fixation device 200, in use, with respect to a first leaflet 202 and a second leaflet 204, respectively, in accordance with an embodiment of the present disclosure. As shown, the leaflet fixation device 200 moves from the open configuration to the closed configuration to clip the first leaflet 202 and the second leaflet 204 between an elongate support body 206 and a first arm 208 and a second arm 210 of the leaflet fixation device 200, respectively, when in use.

[37] Referring to FIG. 3A, illustrated is a schematic illustration of a deployment device 300 for deploying the leaflet fixation device (such as the leaflet fixation device 100 of FIG. 1), in accordance with an embodiment of the present disclosure. As shown, the deployment device 300 comprises a handle 302 adapted to enable a user to hold the deployment device 300, during use thereof for example; a detachment jaw 304 adapted to hold and release a pivot point (such as the pivot point 122 of the leaflet fixation device 100 of FIG. 1) of the leaflet fixation device in a closed configuration and an open configuration thereof, respectively; a detachment rod 306 adapted to operably couple the detachment jaw 304 to the handle 302. As shown, a deployment switch 308 is arranged in the handle 302, wherein the deployment switch 308 is adapted to move the detachment jaw 304 between the closed configuration and the open configuration.

[38] Moreover, the deployment device 300 comprises a first actuating jaw 310 adapted to hold and release a first arm (such as the first arm 112 of the leaflet fixation device 100 of FIG. 1) of the leaflet fixation device in a closed configuration and an open configuration thereof, respectively; a first actuating rod (shown in FIG. 4) adapted to operably couple the first actuating jaw 310 to the handle 302; a first actuating switch (shown in FIG. 4) arranged in the handle 302, wherein the first actuating switch is adapted to move the first actuating jaw 310 between the closed configuration and the open configuration.

[39] Moreover, the deployment device 300 comprises a second actuating jaw 312 adapted to hold and release a second arm (such as the second arm 114 of the leaflet fixation device 100 of FIG. 1) of the leaflet fixation device in a closed configuration and an open configuration thereof, respectively; a second actuating rod (shown in FIG. 4) adapted to operably couple the second actuating jaw 312 to the handle 302; a second actuating switch (shown in FIG. 4) arranged in the handle 302, wherein the second actuating switch is adapted to move the second actuating jaw 312 between the closed configuration and the open configuration. The deployment device 300 comprises a deployment tube 314 adapted to house the detachment rod 306, the first actuating rod, and the second actuating rod. It may be appreciated that proximal ends of the detachment rod 306, the first actuating rod, and the second actuating rod are fixed to the handle 302 via the deployment switch 308, the first actuating switch, and the second actuating switch, respectively. Moreover, the distal ends of the detachment rod 306, the first actuating rod, and the second actuating rod are attached to the detachment jaw 304, the first actuating jaw 310 and the second actuating jaw 312, respectively.

[40] Moreover, when in use, the first actuating switch is adapted to: receive a push to move the first actuating jaw 310 from the open configuration to the closed configuration, and when a first leaflet (such as the first leaflet 202 of FIG. 2) is received between the first arm and a first side of the elongate support body (such as the elongate support body 106 of the leaflet fixation device 100 of FIG. 1) of the leaflet fixation device, receive a pull to move the first actuating jaw 310 from the closed configuration to the open configuration; and the second actuating switch is adapted to: receive a push to move the second actuating jaw 312 from the open configuration to the closed configuration, and when a second leaflet (such as the second leaflet 204 of FIG. 2) is received between the second arm and a second side of the elongate support body of the leaflet fixation device, receive a pull to move the second actuating jaw 312 from the closed configuration to the open configuration. Furthermore, when the first actuating switch and the second actuating switch receive the pull, the deployment switch 308 is adapted to receive a pull to move the detachment jaw 304 from the closed configuration to the open configuration to release the pivot point of the leaflet fixation device and deploy the leaflet fixation device at a target site, such as at the bicuspid valve of a heart.

[41] Referring to FIG. 3B, illustrated is a perspective view of the handle 302 and a sheath 316 of the deployment device of FIG. 3A, in accordance with an embodiment of the present disclosure. As shown, the handle 302 comprises 3 slots 318A-C to receive the deployment switch 308, the first actuating switch and the second actuating switch. As shown, the deployment device 300 further comprises the sheath 316 comprising 3 lumen 320A-C adapted to receive the detachment rod 306, the first actuating rod, and the second actuating rod therein. It may be appreciated the sheath comprising one of the detachment rod 306, the first actuating rod, and the second actuating rod in 3 lumens is housed in the deployment tube 314.

[42] Referring to FIG. 3C, illustrated is an exploded view of the deployment device 300 of FIG. 3A, in accordance with an embodiment of the present disclosure. As shown, the deployment device 300 comprises the handle 302; the detachment jaw 304; the detachment rod 306; the deployment switch 308; the first actuating jaw 310; the first actuating rod 322 adapted to operably couple the first actuating jaw 310 to the handle 302; a first actuating switch 324 arranged in the handle 302; the second actuating jaw 312; the second actuating rod 326 adapted to operably couple the second actuating jaw 312 to the handle 302; the second actuating switch 328 arranged in the handle 302; the deployment tube 314 adapted to house the detachment rod 306, the first actuating rod 322, and the second actuating rod 326 arranged in lumens 320A-C of the sheath 316. Moreover, the deployment switch 308, the first actuating switch 324; the second actuating switch 328 are arranged in slots 318A-C of the handle 302.

[43] Referring to FIG. 4, illustrated is the deployment device 300 of FIG. 3A for deploying the leaflet fixation device 100 of FIG. 1A, when in use, in accordance with the embodiment of the present disclosure. As shown in the left panel, the leaflet fixation device 100 is received in the deployment device 300 in a closed configuration thereof. As shown in the right panel, the leaflet fixation device 100 is operated by the deployment device 300 to shift from the closed configuration to an open configuration thereof, such that both the first actuating jaw 310 and the second actuating jaw 312 are operated simultaneously by the corresponding first actuating switch 324 and second actuating switch 328, respectively, resulting in simultaneous opening of the first arm 112 and the second arm 114 of the leaflet fixation device 100.

[44] Referring to FIG. 5, illustrated is the deployment device 300 of FIG. 3A for deploying the leaflet fixation device 100 of FIG. 1A, when in use, in accordance with the embodiment of the present disclosure. As shown in the left panel, the leaflet fixation device 100 received in the deployment device 300 is operated by the deployment device 300 to shift from the closed configuration to an open configuration thereof, such that the first actuating jaw 310 is operated by the corresponding first actuating switch 324 resulting in opening of the first arm 112 of the leaflet fixation device 100. As shown in the right panel, the leaflet fixation device 100 received in the deployment device 300 is operated by the deployment device 300 to shift from the closed configuration to an open configuration thereof, such that the second actuating jaw 312 is operated by the second actuating switch 328 resulting in opening of the second arm 114 of the leaflet fixation device 100. As shown by the encircled portions, the position of the first actuating jaw 310 and the second actuating jaw 312 changes relative to the deployment switch 308 in shifting the corresponding the first actuating jaw 310 and the second actuating jaw 312 to move the first arm 112 and the second arm 114 in between closed configuration and open configuration, thereof.

[45] Referring to FIG. 6, illustrated is schematic illustration of a deployment device 300 of FIG. 3A for deploying the leaflet fixation device 100 of FIG. 1A, in accordance with another embodiment of the present disclosure. As shown, the deployment device 300 comprises a sleeve 602 and a controller 604 to guide the sleeve 602 to move the leaflet fixation device 100 therethrough to be deployed to (left panel) or retracted from (right panel) a target site. Herein, the sleeve is adapted to receive a portion of a length of the deployment tube and the first and second attachment jaws therein. The term “sleeve” refers to an additional covering around one or more components of the deployment device. Beneficially, the sleeve prevents the deployment device from coming in contact with the body fluids during deployment and retraction activities mediated by the deployment device.

[46] Optionally, the deployment device is made from one of: stainless steel, biocompatible material. Notably, the aforementioned materials are safe for human body and do not cause an allergic reaction to the human.

[47] Referring to FIG. 7, illustrated is schematic illustration of steps of a method to deploy the leaflet fixation device 100 of FIG. 1A at targeted site 702, using the deployment device 300 of FIG. 3A, in accordance with an embodiment of the present disclosure. As shown in A, the deployment device 300 is advanced towards the targeted site 702, through transapical approach for example. As shown in B, the deployment device 300, when at the target site 702, is operated by pushing the first actuating switch 324 of the deployment device 300, the corresponding first actuating jaw 310 of the deployment device 300 is pushed and the first arm 112 of the leaflet fixation device 100 will open and once the first leaflet 202 is captured between the first arm 112 and the first side of the elongate support body 106, the first actuating jaw 310 is pulled back by pulling the first actuating switch 324. Similarly, the second actuating switch 328 of the deployment device 300 is pushed to push the corresponding second actuating jaw 312 of the deployment device 300 which results in the second arm 114 of the leaflet fixation device 100 to open and once the second leaflet 204 is captured between the second arm 114 and the second side of the elongate support body 106, the second actuating jaw 312 is pulled back by pulling the second actuating switch 328. As shown in C, the leaflet fixation device 100 is deployed successfully at the target site 702 of the bicuspid valve. As shown in D, final detachment of the leaflet fixation device 100 is initiated done by pulling the deployment switch 308 which is connected with the deployment rod 306 and the detachment jaw 304 will function like pliers to disengage or detach from the leaflet fixation device 100, while the leaflet fixation device 100 remains deployed at the target site 702 to grip the bicuspid valve leaflets and thus holding closer the pair of leaflets of the bicuspid valve, thereby reducing regurgitation of the left atrium at the bicuspid valve site in heart.

[48] Referring to FIG. 8, illustrated is a flowchart 800 of steps of a method for deploying a leaflet fixation device at a target site, in accordance with an embodiment of the present disclosure. At step 802, the leaflet fixation device is engaged with a deployment device. At step 804, a push is received at a first actuating switch of the deployment device for moving a first actuating jaw of the deployment device from an open configuration to a closed configuration thereof, wherein the first actuating jaw is adapted to hold and release the first arm of the leaflet fixation device in the closed configuration and the open configuration, respectively. At step 806, when the first leaflet is received between a first arm and a first side of an elongate support body of the leaflet fixation device, a pull is received at the first actuating switch of the deployment device for moving the first actuating jaw of the deployment device from the closed configuration to the open configuration. At step 808, a push is received at a second actuating switch of the deployment device for moving a second actuating jaw of the deployment device from an open configuration to a closed configuration thereof, wherein the second actuating jaw is adapted to hold and release the second arm of the leaflet fixation device in the closed configuration and the open configuration, respectively. At step 810, when the second leaflet is received between a second arm and a second side of the elongate support body of the leaflet fixation device, a pull is received at the second actuating switch of the deployment device for moving the second actuating jaw of the deployment device from the closed configuration to the open configuration. At step 812, when the first actuating switch and the second actuating switch receives the pull, a pull is received at a deployment switch of the deployment device for moving a detachment jaw of the deployment device from a closed configuration to an open configuration thereof for releasing a pivot point of the leaflet fixation device and deploying the leaflet fixation device at a target site.

[49] Modifications to embodiments of the invention described in the foregoing are possible without departing from the scope of the invention as defined by the accompanying claims. Expressions such as “including”, “comprising”, “incorporating”, “consisting of”, “have”, “is” used to describe and claim the present invention are intended to be construed in a non-exclusive manner, namely allowing for items, components or elements not explicitly described also to be present. Reference to the singular is also to be construed to relate to the plural. Numerals included within parentheses in the accompanying claims are intended to assist understanding of the claims and should not be construed in any way to limit subject matter claimed by these claims.
, Claims:We claim:
1. A leaflet fixation device (100, 200) comprising:
an elongate support body (106, 206) comprising a plurality of spikes (108A-B) arranged at least partially along a length of the elongate support body;
a clip (110) comprising a first arm (112, 208) and a second arm (114, 210) arranged on either side of the elongate support body, wherein, when in use,
the first arm and a first side of the elongate support body are adapted to receive, via distal ends thereof, a first leaflet (202) therein, and
the second arm and a second side of the elongate support body are adapted to receive, via distal ends thereof, a second leaflet (204) therein; and
a coupling means (116) comprising
a first gripper (118) coupled to the first arm of the clip,
a second gripper (120) coupled to the second arm of the clip, and
a pivot point (122) adapted to moveably couple the first gripper and the second gripper, and fix thereto a proximal end of the elongate support body,
wherein, a coordinated movement of the first gripper and the second gripper around the pivot point allows the first arm and the second arm to move between
an open configuration (102) of the leaflet fixation device comprising a first tension between the first gripper and the second gripper resulting in the first arm and the second arm being angular to the elongate support body, and
a closed configuration (104) of the leaflet fixation device comprising a second tension between the first gripper and the second gripper resulting in the first arm and the second arm being parallel to the elongate support body, wherein the second tension is lower than the first tension,
and wherein the leaflet fixation device moves from the open configuration to the closed configuration to clip the first leaflet and the second leaflet between the elongate support body and the first arm and the second arm, respectively, when in use.
2. The leaflet fixation device (100, 200) as claimed in claim 1, further comprising a slidable cover adapted to at least partially cover at least one of: the elongate support body (106, 206), the first arm (112, 208) of the clip (110), the second arm (114, 210) of the clip.
3. The leaflet fixation device (100, 200) as claimed in claim 1, wherein the first arm (112, 208) and the second arm (114, 210) angularly move withing a range of 5-75 degrees with respect to the elongate support body (106, 206).
4. The leaflet fixation device (100, 200) as claimed in claim 1, wherein the plurality of spikes (108A-B) arranged on the proximal end of the elongate support body (106, 206).
5. The leaflet fixation device (100, 200) as claimed in claim 1, wherein the first tension and the second tension are implemented using a spring.
6. The leaflet fixation device (100, 200) as claimed in claim 1, wherein the leaflet is a bicuspid valve (302) leaflet of a mammalian heart (304).
7. The leaflet fixation device (100, 200) as claimed in claim 2, wherein a fabrication material for:
the elongate support body (106, 206) is stainless steel;
the clip (110) is selected from at least one of: nitinol, stainless steel; and
the slidable cover is polyethylene terephthalate (PET).
8. A deployment device (300) for deploying the leaflet fixation device as claimed in claim 1, the deployment device comprising:
a handle (302) adapted to enable a user to hold the deployment device;
a detachment jaw (304) adapted to hold and release a pivot point of the leaflet fixation device in a closed configuration and an open configuration thereof, respectively;
a detachment rod (306) adapted to operably couple the detachment jaw to the handle;
a deployment switch (308) arranged in the handle, wherein the deployment switch is adapted to move the detachment jaw between the closed configuration and the open configuration;
a first actuating jaw (310) adapted to hold and release a first arm of the leaflet fixation device in a closed configuration and an open configuration thereof, respectively;
a first actuating rod (322) adapted to operably couple the first actuating jaw to the handle;
a first actuating switch (324) arranged in the handle, wherein the first actuating switch is adapted to move the first actuating jaw between the closed configuration and the open configuration;
a second actuating jaw (312) adapted to hold and release a second arm of the leaflet fixation device in a closed configuration and an open configuration thereof, respectively;
a second actuating rod (326) adapted to operably couple the second actuating jaw to the handle;
a second actuating switch (328) arranged in the handle, wherein the second actuating switch is adapted to move the second actuating jaw between the closed configuration and the open configuration; and
a deployment tube (314) adapted to house the detachment rod, the first actuating rod, and the second actuating rod,
wherein when in use:
the first actuating switch is adapted to:
receive a push to move the first actuating jaw from the open configuration to the closed configuration, and
when a first leaflet is received between the first arm and a first side of an elongate support body of the leaflet fixation device, receive a pull to move the first actuating jaw from the closed configuration to the open configuration; and
the second actuating switch is adapted to:
receive a push to move the second actuating jaw from the open configuration to the closed configuration, and
when a second leaflet is received between the second arm and the second side of the elongate support body of the leaflet fixation device, receive a pull to move the second actuating jaw from the closed configuration to the open configuration, and
when the first actuating switch and the second actuating switch receive the pull, the deployment switch is adapted to receive a pull to move the detachment jaw from the closed configuration to the open configuration to release the pivot point of the leaflet fixation device and deploy the leaflet fixation device.
9. The deployment device as claimed in claim 8, further comprising a sheath (316) comprising three lumens (320A-C) adapted to receive the detachment rod, the first actuating rod, and the second actuating rod therein.
10. A method for deploying the leaflet fixation device (100, 200) as claimed in claim 1, the method comprising:
engaging the leaflet fixation device with a deployment device (300);
receiving a push at a first actuating switch (324) of the deployment device for moving a first actuating jaw (310) of the deployment device from an open configuration to a closed configuration thereof, wherein the first actuating jaw is adapted to hold and release a first arm (112, 208) of the leaflet fixation device in the closed configuration and the open configuration, respectively;
when the first leaflet (202) is received between the first arm and a first side of an elongate support body (106, 206) of the leaflet fixation device, receiving a pull at the first actuating switch of the deployment device for moving the first actuating jaw of the deployment device from the closed configuration to the open configuration;
receiving a push at a second actuating switch (328) of the deployment device for moving a second actuating jaw (312) of the deployment device from an open configuration to a closed configuration thereof, wherein the second actuating jaw is adapted to hold and release a second arm (114) of the leaflet fixation device in the closed configuration and the open configuration, respectively;
when the second leaflet (204) is received between the second arm and a second side of the elongate support body of the leaflet fixation device, receiving a pull at the second actuating switch of the deployment device for moving the second actuating jaw of the deployment device from the closed configuration to the open configuration; and
when the first actuating switch and the second actuating switch receives the pull, receiving a pull at a deployment switch (308) of the deployment device for moving a detachment jaw (304) of the deployment device from a closed configuration to an open configuration thereof for releasing a pivot point (122) of the leaflet fixation device and deploying the leaflet fixation device.