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:
CLOSURE 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
[001] The present disclosure relates to a medical device. More specifically, the present disclosure relates to a percutaneous closure device for sealing a vascular tissue.
BACKGROUND OF INVENTION
[002] The heart is the principal organ of the blood circulatory system. The heart includes four compartments (or chambers) which contracts in a rhythmic way to circulate (or pump) blood throughout the body. The left atrial chamber includes an extension in the form of a small pocket-like structure which is also known as the left atrial appendage (LAA). Ideally, in a healthy individual, the LAA is not part of the blood circulatory system.
[003] High cholesterol deposits are known to be linked to blood clot (or thrombus) formation. This clot formation may occur anywhere within the blood circulatory system including inside the LAA of the left atrial. Thrombus within the LAA leads to atrial fibrillation (a type of cardiac arrhythmia).
[004] Irregular pumping of heart due to chronic atrial fibrillation leads to insufficient amount of blood being pumped from the left atrial chamber. Thus, the LAA retains the left-over blood that is not being pumped out of the left atrial chamber. This left-over blood within the LAA significantly increases the size of the clot within the LAA. The clot when stagnant inside the LAA, does not result in any obstruction of pathway of capillary vessels. However, when the clot starts to break into smaller particles, it leads to prolapse of the clot into the blood circulatory system impeding the flow of blood to any part of the vasculature (like brain) which results in stroke (like ischemic stroke).
[005] To reduce the risk of a heart stroke, the LAA is removed through an open-heart surgery during a coronary bypass surgery or valve surgery. However, the risk of open-heart surgery being fatal to an individual, is always high and is preferred as a last resort of treatment.
[006] In recent times, an alternate to open-heart surgery, is implantation of a Left Atrial Appendage Closure (LAAC) device. These typically cater to patients who were not suitable for open-heart surgeries. An LAAC device implantation is a minimally invasive procedure that is used to reduce the risk of a stroke that results from atrial fibrillation (also known as Afib or AF).
[007] The LAA is in continuous movement due to rhythmic contraction and dilation of the pumping/palpitating heart. Further, the flow of blood makes the LAA slippery. Under such circumstances, it is difficult to deploy a conventional LAAC device. More often than not, the LAAC device is incorrectly implanted and/or migrates post deployment.
[008] In additional, a conventional LAAC device also suffers from post-implantation peri-device leakage. In other words, after the conventional LAAC device has been implanted, blood flow leakage has been observed from around the periphery of the LAAC device. This makes the LAAC device ineffective and the risk of stroke is still maintained post-implantation.
[009] Thus, there is a need for an improved closure device which overcomes the aforementioned challenges associated with the conventional devices.
SUMMARY OF THE INVENTION
[0010] 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.
[0011] The present disclosure relates to a device including a frame and a membrane. The frame is made of a plurality of frame members arranged circumferentially. Each frame member of the plurality of frame members includes a first portion, and a second portion disposed distal to the first portion. The membrane is disposed at least partially over at least one of an outer surface or inner surface of the frame. The first portions of the plurality of frame members are at least partially coupled to each other. The second portion bulges outward with respect to the first portion, thereby preventing peri-device leakage.
BRIEF DESCRIPTION OF DRAWINGS
[0012] 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 instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[0013] Figs. 1 and 1a depict a device 100 being implanted in a LAA 1a according to an embodiment of the present invention.
[0014] Fig. 2 depicts the device 100 according to an embodiment of the present invention.
[0015] Fig. 2a depicts a frame 110 of the device 100 according to an embodiment of the present invention.
[0016] Fig. 2b depicts a frame member 111 of the frame 110 according to an embodiment of the present invention.
[0017] Fig. 3 depicts a proximal view of the frame 110 according to an embodiment of the present invention.
[0018] Fig. 4 depicts a proximal view of the device 100 according to an embodiment of the present invention.
DETAILED DESCRIPTION OF DRAWINGS
[0019] Prior to describing the invention in detail, definition 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.
[0020] 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.
[0021] 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.
[0022] 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.
[0023] The present disclosure discloses a closure device (or device). The device may be used for closure of a vascular orifice. In an exemplary embodiment, the device is implanted at an entrance (or ostium) of the left atrial appendage (LAA) of the heart. Although the present disclosure is described with the example of LAA, the device of the present disclosure can be implanted across any vascular orifice and the same is within the scope of the teachings of the present disclosure.
[0024] The device of the present disclosure is flexible and conforms to various anatomies of vascular orifices. The device of the present invention prevents migration of the blood clots in patients suffering from Atrial fibrillation (AFib or AF) from the Left Atrial Appendage (LAA) to the rest of the circulatory system and thus leads to the prevention of transient ischemic attack, a stroke or a blood vessel blockage called an embolism.
[0025] The device of the present disclosure is provided with a self-expandable frame that is at least partially covered with a membrane. The membrane of the device promotes uniform and fast endothelialization after deployment at the target site. Aforesaid endothelialization plays a vital role in supply of oxygen and other nutrients to the tissues in the proximity of the device (such as, parts of the LAA) which are essential for healthy rhythmic movement of the whole heart. The membrane is impermeable to the flow of blood or bodily fluids but plays a vital role in passing sufficient oxygen and nutrients to the tissues in the proximity of the device.
[0026] A portion of the frame is provided with a bulging portion that prevents any potential risk of peri-device leak (PDL) post-implantation. The frame of the device promotes atraumatic deployment in the LAA. The device is provided with a plurality of barbs that help the device to engage with the surrounding tissue of the LAA thereby, preventing device migration and providing long-term stability to the device after deployment.
[0027] Now referring to the figures, Fig. 1 depicts a heart 1 with a diseased left atrial appendage (LAA) 1a. The heart 1 pumps and circulates blood throughout a blood circulatory system. In an exemplary embodiment, as shown in Fig. 1, an exemplary device 100 of the present disclosure is implanted at an entrance of the LAA 1a to seal the entrance of the LAA 1a. The entrance of the LAA 1a may be defined as an orifice through which there is a potential risk of a thrombus migration from the LAA 1a to the entire blood circulatory system. The device 100 extends between a proximal end 100a and a distal end 100b (as shown in Fig. 1a).
[0028] The device 100 is radially collapsible from a radially expandable state to a radially collapsed state. And, the device 100 is radially expandable from the radially collapsed state to the radially expanded state. In an exemplary embodiment, the device 100 is self-expandable from the radially collapsed state to the radially expandable state.
[0029] The device 100 is radially collapsed and percutaneously advanced towards the LAA 1a via, for example, a delivery sheath 200. The delivery sheath 200 helps to constrain the device 100 in its radially collapsed state. The delivery sheath 200 encloses a delivery wire 210 operationally coupled to the proximal end 100a of the device 100. At the LAA 1a, the device 100 is radially expanded by either retracting the delivery sheath 200 from over the device 100 or by pushing the device 100 (and at least partially the delivery wire 210) out of the delivery sheath 200. The delivery wire 210 is then decoupled from the device 100 and withdrawn along with the delivery sheath 200.
[0030] Post-implantation, the proximal end 100a of the device 100 faces away from the LAA 1a and the distal end 100b of the device 100 faces towards the LAA 1a. The said disposition of the device 100 with respect to the LAA 1a helps to prevent migration of the blood clots from the LAA 1a to the rest of the circulatory system and thus lead to the prevention of transient ischemic attack, a stroke or an embolism.
[0031] Although the device 100 is described with an exemplary delivery sheath 200 for implantation, other functionally equivalent delivery devices are within the scope of the teachings of the present disclosure.
[0032] Fig. 2 depicts the device 100. The device 100 includes a frame 110 and at least one membrane 130 disposed at least partially over the frame 110. The proximal end 100a of the device 100 is close ended and the distal end 100b of the device 100 is open ended. In other words, close ended refers to an end which does not include an opening while open ended refers to an end which includes an opening via which at least partially, inner portions including the proximal end 100a of the device 100 are accessible. The device 100 may have a pre-defined shape including, but not limited to, hemisphere, spherical, oval, parabolic, etc. In an exemplary embodiment, as shown in Fig. 2, the device 100 is hemi-spherically shaped.
[0033] The frame 110 of the device 100 is depicted in Fig. 2a. The frame 110 may be dimensioned basis the anatomy of the LAA 1a. The frame 110 may be made of one or more shape-memory materials including, but not limited to, nitinol (nickel-titanium alloy), cobalt-chromium (Co-Cr), titanium, stainless steel, etc. In an exemplary embodiment, the frame 110 is made of nitinol. The shape-memory material of the frame 110 enables the frame 110 (and the device 100) to self-expand from the radially collapsed state to the radially expanded state at the time of implantation.
[0034] Alternatively, the frame 110 may be made of polymeric materials including, but not limited to, polydioxanone (PDO), poly(lactic-co-glycolic) acid (PLGA), etc. and the same is within the scope of the teachings of the present disclosure. In such case, at the time of deployment, the frame 110 is expanded using an external mechanism.
[0035] In an embodiment, the frame 110 includes a plurality of frame members 111 arranged circumferentially and equidistantly around the device 100. Alternatively, not shown, the frame members 111 may be irregularly arranged around the device 100. In an exemplary embodiment, as shown in Fig. 2a, the frame 110 includes six frame members 111 arranged circumferentially around the device 100.
[0036] In an exemplary embodiment, as shown in Fig. 2a, the frame members 111 are coupled to each other at the proximal end 100a of the device 100 via the adapter 113. The frame members 111 are configured to adapt to the surrounding tissue of the LAA 1a once the device 100 is radially expanded within the LAA 1a. The frame members 111 thus conform to the annulus defined by the surrounding tissue of the LAA 1a. Further, the frame members 111 at least partially prevent the device 100 from migrating away from the LAA 1a after the device 100 is implanted.
[0037] Fig. 2b depicts one of the plurality of frame members 111 of the device 100. Each frame member 111 includes one or more portions extending between the proximal end 100a and the distal end 100b of the device 100. In an exemplary embodiment, as shown in Fig. 2b, the frame member 111 is provided with a first portion 111a, a second portion 111b, and a third portion 111c. The first portion 111a is disposed at the proximal end 100a of the device 100. In an exemplary embodiment, not shown, the proximal end 100a of the first portion 111a of all the frame members 111 are coupled to each other. In another exemplary embodiment, as shown in Fig. 2a, the proximal end 100a of the first portion 111a of all the frame members 111 are coupled to each other via the adapter 113. The first portion 111a is coupled to the adapter 113 via one of laser welding, welding, soldering, brazing, etc. In an exemplary embodiment, the first portion 111a is coupled to the adapter 113 via laser welding.
[0038] The first portion 111a may have a length ranging from 14 mm to 20 mm. In an exemplary embodiment, the length of the first portion 111a is 17 mm. The first portion 111a includes a V-shaped strut 111a1. In an embodiment, the V-shaped strut 111a1 are radially curved along its length, i.e., the V-shaped strut 111a1 conforms to and defines the hemispherical shape of the device 100. In an alternative embodiment, not shown, the V-shaped strut 111a1 are substantially straight. In yet another embodiment, not shown, the V-shaped strut 111a1 are at least partially wavy. The V-shaped strut 111a1 extends away from the adapter 113 towards the distal end 100b of the device 100. The V-shaped strut 111a1 is formed by at least two arms ‘A’ defining a pre-defined angle therebetween. The pre-defined angle ranges from 15° to 60°. In an exemplary embodiment, the pre-defined angle is 30°. The V-shaped strut 111a1, leveraging the adapter 113, provides a radially expanding force to the second portion 111b of the frame member 111.
[0039] In an exemplary embodiment, as shown in Fig. 2b, the two arms ‘A’ of the frame member 111 are coupled to each other. In another exemplary embodiment, as shown in Fig. 2a, the two arms ‘A’ of the frame member 111 are separate from each other.
[0040] The second portion 111b of the frame member 111 is disposed distal to the first portion 111a. Further, the second portion 111b is disposed between the first portion 111a and the third portion 111c. The second portion 111b defines a bulging portion of the frame 110. The second portion 111b of each of the frame member 111 includes at least one C-shaped struts 111b1. Alternatively, the at least one C-shaped struts 111b1 may be replaced with stepped struts, wavy struts, inverted-C struts, triangular struts, or a combination thereof and the same is within the scope of the teachings of the present disclosure. In an exemplary embodiment, as shown in Fig. 2b, the second portion 111b of the frame member 111 includes two C-shaped struts 111b1. The C-shaped struts 111b1 bulges circumferentially away from the first portion 111a and the third portion 111c of the frame member 111 thus defining the bulging portion of the frame 110. The C-shaped struts 111b1 may define an intrinsic radius ranging from 2 mm to 6 mm. In an exemplary embodiment, the intrinsic radius of the C-shaped struts 111b1 is 3 mm. The C-shaped struts 111b1 of the second portion 111b abut the surrounding tissue of the LAA 1a post implantation thereby preventing the device 100 from migrating away from the LAA 1a. The second portion 111b at least partially helps the device 100 to prevent peri-device leak.
[0041] Although the second portion 111b of the present disclosure is described with C-shaped struts 111b1, other functionally equivalent shapes of the second portion 111b that causes the second portion 111b to bulge out are within the scope of the teachings of the present disclosure.
[0042] The frame member formed of the first portion 111a, second portion 111b, and third portion 111c, resemble a finger-like projection that is fixed at one end and free to move at the other end. This provides flexibility to the device as the device can adjust or move to conform to the anatomy.
[0043] At least one C-shaped strut 111b1 of the second portion 111b is optionally provided with one or more barbs 111b2. In an exemplary embodiment, as shown in Fig. 3, all the C-shaped struts 111b1 are provided with respective barbs 111b2. The barbs 111b2 are made of one or more materials including, but not limited to, nitinol, Co-Cr, titanium, stainless steel, drawn filled tubes (DFT), etc. In an exemplary embodiment, the barbs 111b2 are made of nitinol. At least a portion of the barb 111b2 is coupled to an outer surface of the second portion 111b via at least one of welding, bonding, laser welding, soldering, etc. The barb 111b2 may be coupled either close to the first portion 111a, the third portion 111c, a center of the second portion 111b or a combination thereof. In an exemplary embodiment, the barbs 111b2 are coupled to the center of the C-shaped struts 111b1 via laser welding. Alternately, the barbs 111b2 may be scattered and coupled at different spots on the second portion 111b. The barbs 111b2 are configured to pierce the surrounding tissue of the LAA 1a to anchor the device 100 at the LAA 1a. Along with the frame members 111, the barbs 111b2 are also circumferentially arranged at least partially around the device 100. The barb 111b2 help the device 100 to engage with the surrounding tissue of the LAA 1a thereby, preventing migration and providing long-term stability to the device 100 after deployment.
[0044] The barbs 111b2 may have a pre-defined shape including, but not limited to, C-shape, J-shape, U-shape, V-shape, etc. In an exemplary embodiment, as shown in Fig. 2b, the barbs 111b2 are C-shaped. A free end of the barbs 111b2 may point towards the proximal end 100a of the device 100 such that even if the device 100 is pushed out of the LAA 1a, anchorage provided by the barbs 111b2 improves.
[0045] The third portion 111c is disposed towards the distal end 100b. Alternatively, the frame member 111 (and the device 100) may be made without a third portion 111c and the same is within the scope of the teachings of the present disclosure. The third portion 111c may have a length ranging from 6 mm to 10 mm. The third portion 111c may have a width ranging from 0.15 mm to 0.25 mm. In an exemplary embodiment, the length and width of the third portion 111c is 8 mm, and 0.17 mm respectively. The third portion 111c of the frame member 111 is disposed distal to the second portion 111b. The third portion 111c includes a U-shaped strut 111c1. The two ends of the U-shaped strut 111c1 are coupled to respective C-shaped struts 111b1 of the second portion 111b. The U-shaped strut 111c1 may either be stepped, regular, irregular, wavy, curved, conical, or a combination thereof. In an exemplary embodiment, as shown in Fig. 2b, the third portion 111c of the frame member 111 includes regular U-shaped struts 111c1. The U-shaped strut 111c1 provides atraumatic and easy insertion of the device 100 within the LAA 1a.
[0046] Although the third portion 111c of the frame member 111 is described with examples of U-shaped struts 111c1, other functionally equivalent shapes of the third portion 111c that provides atraumatic deployment of the device 100 are within the scope of the teachings of the present disclosure.
[0047] Although not shown, at least one U-shaped strut 111c1 of the third portion 111c is optionally provided with one or more barbs. At least a portion of the barb is coupled to an outer surface of the third portion 111c via at least one of welding, bonding, laser welding, soldering, etc. The barb may be coupled either close to the second portion 111b, the distal end 100b, a center of the third portion 111c or a combination thereof. Alternately, the barbs may be scattered and coupled at different spots on the third portion 111c. The barbs of the third portion 111c may be structurally and/or functionally same as the barbs 111b2 of the second portion 111b.
[0048] The frame members 111 are described as being constituted of discrete first portion 111a, the second portion 111b, and the third portion 111c, however, the three portions may be integrally formed. Alternatively, the portions of a frame member 111 may be fixedly coupled to each other.
[0049] The frame 110 of the device 100 is optionally provided with one or more radiopaque markers (not shown). The radiopaque markers may be made of one or more materials including, but not limited to, stainless steel, platinum iridium, platinum tungsten, tantalum, etc. In an exemplary embodiment, the radiopaque markers are made of platinum iridium. The radiopaque markers help to visualize the device 100 using fluoroscopy imaging techniques after and/or during the deployment of the device 100.
[0050] The radiopaque markers are provided with at least one of the adapter 113 and/or the C-shaped struts 111b1 of the second portion 111b of the frame members 111. The radiopaque marker provided with the adapter 113, helps to visualize the position of the proximal end 100a of the device 100. And, the radiopaque markers provided with the second portion 111b of the frame 110 help to visualize the radial expansion of the device 100 from the radially collapsed state to the radially expandable state.
[0051] The proximal end 100a of the frame 110 is depicted in Fig. 3 depicting the frame members 111 of the frame 110 coupled to the adapter 113. In an exemplary embodiment, as shown in Fig. 3, the adapter 113 is a cup shaped body. Other shapes of the adapter 113 is within the scope of the teachings of the present disclosure.
[0052] The adapter 113 defines a cavity 113a disposed at the proximal end 100a of the device 100. The cavity 113a is configured to operationally coupled to the delivery wire 210 of the delivery sheath 200.
[0053] In an exemplary embodiment, the cavity 113a and a distal end of the delivery wire 210 are provided with complementing plurality of threads. The plurality of threads facilitates the device 100 to be screwed at the distal end of the delivery wire 210. Accordingly, the device 100 may be unscrewed from the distal end of the delivery wire 210 post-implantation.
[0054] Although the coupling between the delivery wire 210 and the adapter 113 of the device 100 is described with the example of the plurality of threads, other functionally equivalent mechanisms/structures are within the scope of the teachings of the present disclosure.
[0055] In an alternate embodiment, instead of the adapter 113, the proximal end 100a of the frame members 111 are coupled to each other to form a flange (not shown) provided with a plurality of threads. The flange may be functionally similar to the adapter 113.
[0056] Fig. 4 depicts the at least one membrane 130 disposed over at least a portion of an outer surface and/or an inner surface of the frame 110. In an exemplary embodiment, the membrane 130 is disposed over a proximal portion of the outer surface of the frame 110.
[0057] In an exemplary embodiment, as shown in Fig. 2, the membrane 130 extends from the proximal end 100a of the frame 110 to the barbs 111b2 of the second portion 111b of the frame members 111. The membrane 130 covers the first portion 111a of the frame members 111 and at least partially covers the second portion 111b of the frame members 111. In the depicted embodiment, the third portion 111c is not covered by the membrane 130. The second portion 111b, being relatively bulged out of the frame 110, along with the membrane 130 prevents peri-device leak.
[0058] In an alternate embodiment, not shown, the first portion 111a, the second portion 111b and the third portion 111c is covered with the membrane 130.
[0059] The proximal end 100a of the membrane 130is optionally provided with an opening 131 corresponding to the cavity 113a of the adapter 113. The opening 131 allows the delivery wire 210 to be operationally coupled to the adapter 113 of the frame 110. An outer diameter of the adapter 113 is greater than the diameter of the opening 131 of the membrane 130. The adapter 113, thus, prevents any leakage of blood (or clots thereof) through the opening 131 of the membrane 130.
[0060] The membrane 130 is made of one or more woven or non-woven fabrics, including but not limited to, Polyethylene terephthalate (PET) fabric, polyester fabric, etc. In an exemplary embodiment, the membrane 130 is made of PET fabric. The membrane 130 of the device promotes uniform and fast endothelialization post-implantation. Aforesaid endothelialization plays vital role in supply of oxygen and other nutrients to the tissues in the proximity of the device (such as, parts of the LAA) which are essential for health rhythmic movement of the whole heart. The membrane 130 is impermeable to flow of blood, clots or bodily fluids but plays a vital role in passing sufficient oxygen and nutrients to the tissues in the proximity of the device.
[0061] 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 frame (110) made of a plurality of frame members (111) arranged circumferentially, each frame member (111) of the plurality of frame members (111) includes:
i. a first portion (111a), and
ii. a second portion (111b) disposed distal to the first portion (111a); and
b. a membrane (130) disposed at least partially over at least one of an outer surface or inner surface of the frame (110);
wherein, the first portions (111a) of the plurality of frame members (111) are at least partially coupled to each other; and
wherein, the second portion (111b) bulges outward with respect to the first portion (111a), thereby preventing peri-device leakage.
2. The device (100) as claimed in claim 1, wherein the first portion (111a) includes a V-shaped strut (111a1) having at least two arms ‘A’.
3. The device (100) as claimed in claim 1, wherein the first portion (111a) includes at least two arms ‘A’ defining a pre-defined angle therebetween ranging from 15° to 60°.
4. The device (100) as claimed in claim 1, wherein at least a portion of the first portions (111a) of the plurality of frame members (111) are coupled to an adapter (113) optionally defining a cavity (113a).
5. The device (100) as claimed in claim 1, wherein the second portion (111b) includes at least two C-shaped struts (111b1) bulging circumferentially away from the first portion (111a).
6. The device (100) as claimed in claim 1, wherein each of the frame members (111) are provided with a third portion (111c) including a U-shaped strut (111c1) disposed distal to the second portion (111b).
7. The device (100) as claimed in claim 6, wherein an outer surface of at least one of the second portion (111b) and the third portion (111c) is coupled to one or more barbs (111b2).
8. The device (100) as claimed in claim 7, wherein the barbs (111b2) are coupled to the frame members (111) via at least one of welding, bonding, laser welding, and soldering.
9. The device (100) as claimed in claim 7, wherein the barbs (111b2) include one of a C-shape, a J-shape, a U-shape, and a V-shape.
10. The device (100) as claimed in claim 7, wherein the membrane (130) is disposed over the first portion (111a), the second portion (111b) and at least partially over the third portion (111c).
11. The device (100) as claimed in claim 1, wherein the frame members (111) include one or more radiopaque markers.
12. The device (100) as claimed in claim 1, wherein the frame (110) is made of one or more shape-memory materials including nitinol (nickel-titanium alloy), cobalt-chromium (Co-Cr), titanium, stainless steel, or a combination thereof.
13. The device (100) as claimed in claim 1, wherein the first portion (111a) includes a V-shaped strut (111a1) that are one of radially curved, substantially straight, and at least partially wavy.
14. The device (100) as claimed in claim 1, wherein the second portion (111b) includes one of a C-shaped strut 111b1, stepped struts, wavy struts, and inverted-C struts.