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:
IMPLANT FOR CLOSING THE LEFT ATRIAL APPENDAGE
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 invention relates to a medical device. More specifically, the present invention relates to an implant for closing the Left Atrial Appendage (LAA).
BACKGROUND OF INVENTION
[002] The left atrial appendage (LAA) is a small, ear-shaped pouch in the heart's left atrium. The LAA helps regulate blood volume, by managing the fluids in the body. Also, the LAA acts as a decompression chamber by accommodating fluctuations in blood volume and pressure, preventing excessive pressure buildup within the left atrium of the heart.
[003] However, the LAA is the most common site for blood clot formation in individuals with conditions such as, atrial fibrillation (AFib). Atrial fibrillation (AFib) is a common heart rhythm disorder, where the upper chambers of the heart (the atria) beat irregularly and rapidly. Other conditions contributing to clot formation in LAA include a valvular heart disease, heart failure with reduced ejection fraction (HFrEF), etc. The one or more clots formed in the LAA can break and travel to the brain, causing a stroke. The standard treatment for stroke prevention is a long-term anticoagulation (blood-thinning) medication. However, anticoagulation carries its own risks, primarily bleeding, gastrointestinal effects, etc. Therefore, closing off the LAA effectively eliminates this primary source of stroke-causing clots.
[004] Conventionally, an occluder device is implanted in a patient’s heart to close the LAA in a patient. The conventional device is implanted at a target site of the LAA through a catheter. However, the conventional device poses some serious limitations. In many cases, the conventional device migrates from the implanted site causing serious complications. For example, the dislodged conventional device can travel through the blood stream and embolize other parts of the body, resulting in serious consequences. Additionally, the conventional device fails to completely seal of the LAA, due to improper membrane attachment with the device, resulting in residual leaks, and increasing the risk of blood clot formation.
[005] Hence, there is a need for an implant which can overcome the above limitations.
SUMMARY OF INVENTION
[006] The present disclosure relates to an implant for closing the left atrial appendage (LAA). The implant includes a frame. The frame includes a tubular section, a plurality of undulating struts, a first row of first struts a plurality of first anchors, a plurality of second anchors and a second row of second struts. The plurality of undulating struts is arranged circumferentially and extend radially outward from the tubular section. The first struts of the first row are connected to each other to form alternating peaks and troughs. Each of the peaks of the first row is coupled to a distal end of a corresponding undulating strut. The plurality of first anchors is arranged circumferentially. Each first anchor includes a first slab and one or more first spikes. The first slab is coupled to a corresponding trough of the first row. The one or more first spikes protrude from the first slab in a first direction and are configured to penetrate an annular wall of the LAA. The plurality of second anchors is arranged circumferentially. Each second anchor includes a second slab and one or more second spikes. The second slab is coupled to a corresponding trough of the first row. The one or more second spikes protrude from the second slab in a second direction and are configured to penetrate an annular wall of the LAA. The second direction is opposite to the first direction. The second struts of the second row are connected to each other to form alternating peaks and troughs. Each of the peaks of the second row is coupled to the first slab of a respective first anchor or to the second slab of a respective second anchor.
[007] The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF DRAWINGS
[008] 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.
[009] Fig. 1 depicts a side view of an implant 100 for closing the left atrial appendage (LAA), in accordance to an embodiment of the present disclosure.
[0010] Figs. 2a-2b depict the implant 100 implanted in the left atrial appendage (LAA) of the heart of a patient, in accordance to an embodiment of the present disclosure.
[0011] Fig. 3a depicts a side view of a frame 200 of the implant 100, in accordance to an embodiment of the present disclosure.
[0012] Fig. 3b depicts a perspective view of the frame 200 of the implant 100, in accordance to an embodiment of the present disclosure.
[0013] Fig. 3c depicts a top view of the frame 200 of the implant 100, in accordance to an embodiment of the present disclosure.
[0014] Fig. 4a depicts a view of the frame 200 illustrating a tubular section 305, a plurality of undulating struts 310, a first row 315a of a plurality of first struts 315 and a plurality of first links 320 of the frame 200, in accordance with an embodiment of the present disclosure.
[0015] Fig. 4b depicts an extension 360 of the frame 200, coupled to a pair of adjacent undulating struts 310, according to an embodiment of the present disclosure.
[0016] Fig. 5a depicts a first anchor 330 of a plurality of first anchors 330 of the frame 200, in accordance to an embodiment of the present disclosure.
[0017] Fig. 5b depicts a second anchor 345 of a plurality of second anchors 345 of the frame 200, in accordance to an embodiment of the present disclosure.
[0018] Fig. 6 depicts a second row 405a of a plurality of second struts 405, and a plurality of connectors 410 of the frame 200, in accordance to an embodiment of the present disclosure.
[0019] Fig. 7 depicts a flowchart of a method 600 for the delivery of the implant 100, in accordance to an embodiment of the present disclosure.
[0020] Fig. 8 depicts a flowchart of a method 700 for the manufacture of the implant 100, in accordance to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0021] 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.
[0022] 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.
[0023] 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.
[0024] 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.
[0025] In accordance with the present disclosure, an implant for closing the left atrial appendage (LAA) is disclosed. The implant is implanted at the LAA of the heart of a patient through a minimally invasive procedure with the help of a catheter. The implant is used to close the LAA of the heart of the patient, mitigating the formation of blood clots in the LAA and complications associated thereof.
[0026] In an embodiment, the implant includes a plurality of first anchors and a plurality of second anchors configured to grip an annular wall of the LAA. In an embodiment, the first and second anchors are oriented in anti-parallel (or opposite) directions. Consequently, the first and second anchors grip the annular wall from opposite directions, providing a better grip to the implant as compared to conventional devices, which have anchors oriented in only one direction. Consequently, the stability of the implant is improved and the risk of implant migration is mitigated. Thus, the overall patient outcome is improved.
[0027] Now referring to figures, Fig. 1 depicts an implant for closing the LAA (hereinafter an implant 100) of the heart of a patient, preventing the blood to flow into the LAA according to an embodiment of the present disclosure. The implant 100 is implanted in the left atrial appendage (LAA) of the heart using a minimally invasive procedure. The implant 100 has a proximal end 100a and a distal end 100b. The implant 100 includes without limitation, a frame 200 and a membrane 500 coupled to the frame 200. The frame 200 provides structure and strength to the implant 100, and the membrane 500 provides sealing to the implant 100, preventing the passage of blood through it. The implant 100 may be dimensioned according to the anatomy of the patient or patient population in consideration.
[0028] Figs. 2a and 2b illustrate the implant 100 implanted in the LAA of a patient.
[0029] Figs. 3a-3c depict various views of the frame 200, according to an embodiment. The frame 200 has a proximal end 200a, a distal end 200b, an outer surface and an inner surface (as shown in Fig. 3a). The frame 200 is made of a biocompatible, self-expanding material such as without limitation, Nitinol, Platinum, etc. In an embodiment, the frame 200 is made of Nitinol. According to an embodiment, the frame 200 is laser-cut from a single tube made of a desired biocompatible, self-expanding material. The frame 200 is configurable to be in a crimped state, e.g., during the delivery of the implant 100 and in a radially expanded state, e.g., upon deployment. In an embodiment, the frame 200 in the radially expanded state, has a predefined diameter ‘W’ ranging from 10mm to 45mm. In an embodiment, the predefined diameter W is 24mm.
[0030] The frame 200 includes a tubular section 305. The tubular section 305 is disposed towards the proximal end 200a of the frame 200. The tubular section 305 includes a lumen 305b extending for the length of the tubular section 305. The tubular section 305 is configured to couple with a delivery catheter used for deploying the implant 100 and thus, acts as an attachment point for the delivery catheter. The tubular section 305 is coupled to the delivery catheter using a jacket 305c (shown in Fig. 4b).
[0031] The jacket 305c is coupled to the lumen 305b of the tubular section 305. The jacket 305c may be coupled to the lumen 305b using a suitable technique such as, welding, threads, etc. In an embodiment, the jacket 305c is coupled to the lumen 305b using welding. In an embodiment, the jacket 305c includes a plurality of female threads 305c1 (shown in Fig. 4b) while, a delivery cable of the delivery catheter includes a plurality of male threads. The female threads 305c1 of the jacket 305c are configured to couple to the male threads of the delivery cable.
[0032] The tubular section 305 has a substantially cylindrical shape with a predefined outer diameter ranging from 2mm to 4mm and a predefined thickness ranging from 0.1mm to 0.3mm. In an embodiment, the predefined outer diameter of the tubular section 305 is 3.2mm and the predefined thickness of the tubular section 305 is 0.15mm. The tubular section 305 has an inner surface and an outer surface. The tubular section 305 may include one or more apertures 305a provided on a curved surface of the tubular section 305. In an embodiment, the tubular section 305 includes two apertures 305a positioned diametrically opposite to each other. The apertures 305a may have a predefined shape including rounded, square, diamond, pentagon etc. In an embodiment, the apertures 305a are rounded, with a predefined diameter ranging from 0.5mm to 1.5mm. In an embodiment, the predefined diameter of the apertures 305a is 1mm. The apertures 305a are used to attach the delivery catheter to the tubular section 305.
[0033] The frame 200 further includes a plurality of undulating struts 310. The plurality of undulating struts 310 (hereinafter, undulating struts 310) is circumferentially arranged and extends radially outwards from the tubular section 305 as shown in Fig. 4a. The undulating struts 310 are coupled to the tubular section 305. In an exemplary embodiment, a proximal end of each undulating strut 310 is integrally coupled to a distal end of the tubular section 305. In an embodiment, each undulating strut 310 includes a first portion 310a and a second portion 310b.
[0034] The first portion 310a of the undulating strut 310 is curved, including one or more curved sections. The first portion 310a has a first end and a second end. In an embodiment, the first portion 310a is U-shaped having a first arm 310a1, a second arm 310a2 and a connecting portion 310a3 disposed between the first arm 310a1 and the second arm 310a2. The first arm 310a1 of the undulating strut 310 is coupled to the tubular section 305. The first arm 310a1 extends towards the distal end 200b of the frame 200 and the second arm 310a2 extends from the connecting portion 310a3 towards the proximal end 200a. In an embodiment, the second arm 310a2 extends to the proximal end 200a of the frame 200, aligning with the proximal end of the tubular section 305. In other words, the second end of the first portion 310a aligns with the proximal end of the tubular section 305 thus, providing strength to the implant 100.
[0035] The first end of the first portion 310a is coupled to the tubular section 305. More specifically, the first end of the first portion 310a is coupled to a distal end of the tubular section 305. The second end of the first portion 310a is coupled to the second section 310b. More specifically, the second portion 310b extend from the second end of the second arm 310a2 of the first section 310a. The length of the first arm 310a1, second arm 310a2 and connecting portion 310a3 may range from 1mm to 5mm, from 3mm to 10mm and from 0.5mm to 3mm respectively. In an exemplary embodiment, the length of the first arm 310a1, the second arm 310a2 and the connecting portion 310a3 are 3mm, 6mm and 1mm, respectively. The cross-section of the first portion 310a may be at least one of a circular, rectangular, etc. In an embodiment, the cross-section of the first portion 310a is rectangular, having a predefined width ranging from 0.1mm to 0.4mm and a predefined thickness ranging from 0.1mm to 0.3mm. In an embodiment, the predefined width of the first portion 310a is 0.25mm. In an embodiment, the thickness of the first portion 310a is 0.15mm.
[0036] The second portion 310b of the undulating strut 310 may have a predefined structure, such as, straight, curved, etc. In an embodiment, the second portion 310b is straight. The cross-section of the second portion 310b may be one of circular, rectangular, etc. In an embodiment, the cross-section of the second portion 310b is rectangular, having a predefined width ranging from 0.1mm to 0.4mm and a predefined thickness ranging from 0.1mm to 0.3mm. In an embodiment, the width of the second portion 310b is 0.25mm. In an embodiment, the thickness of the second portion 310b is 0.15mm. The length of the second portion 310b ranges from 5mm to 10mm. In an embodiment, the length of the second portion 310b is 7mm. The first portion 310a and the second portion 310b of the undulating strut 310 may have the same or different width and thickness. In an embodiment, the first portion 310a and the second portion 310b of the undulating strut 310 have the same width and thickness.
[0037] The second portion 310b has a first end and a second end. The first end of the second portion 310b is coupled to the second end of the first portion 310a. In an embodiment, the first portion 310a is curved at the first end and the second end. The second portion 310b extends from the second end of the second arm 310a2 towards the distal end 200b, and defining (or making) a predefined angle ‘A’ ranging from 70 degrees to 120 degrees. In an embodiment, the angle ‘A’ is 100 degrees. In an embodiment, the second portion 310b extends in a radially outward direction with respect to the longitudinal axis of the frame 200. More specifically, the first end of the second portion 310b couples to the first portion 310a forming a peak projecting towards the proximal end 200a of the frame 200.
[0038] The frame 200 includes a plurality of extensions 360 coupled to the plurality of undulating struts 310 as shown in Fig. 4b. The extensions 360 are coupled to alternate pairs of adjacent undulating struts 310. In an embodiment, each extension 360 includes two flared arms 360a defining one vertex 360b. The extensions 360 may be without limitation, V-shaped, U-shaped, C-shaped, etc. According to an embodiment, the extension 360 is V-shaped. In an embodiment, a first end and a second end of the extension 360 is curved, though it is possible that they may be straight.
[0039] The extensions 360 extend towards a longitudinal axis of the frame 200. More specifically, the vertex 360b of the extension 360 projects towards the tubular section 305, i.e., towards the longitudinal axis of the frame 200. In an embodiment, each extension 360 is coupled to a pair of adjacent undulating struts 310. More specifically, each flared arm 360a of the extension 360 is coupled to one undulating strut 310 of the pair of adjacent undulating struts 310. In an embodiment, the flared arms 360a are coupled at the conjunction of the first portion 310a and the second portion 310b of the respective undulating strut 310 (as shown in Fig. 4b). The plurality of extensions 360 provide strength to the frame 200. The extensions 360 also provide more surface for coupling the membrane 500 to the frame 200. Consequently, the membrane 500 is coupled to the frame 200 more securely, minimizing chances of detachment of the membrane 500.
[0040] The length of each flared arm 360a of the extension 360 may range from 3mm to 10mm. In an embodiment, the length of the flared arms 360a is 6mm. The flared arm 360a may subtend a predefined angle ‘B’ at the vertex 360b ranging from 20 degrees to 40 degrees. In an embodiment, the predefined angle ’B’ is 30 degrees. The cross-section of the extensions 360 may be one of circular, rectangular, etc. In an embodiment, the cross-section of the extensions 360 is rectangular, having a predefined width ranging from 0.1mm to 0.4mm and a predefined thickness ranging from 0.1mm to 0.3mm. In an embodiment, the predefined width of the extensions 360 is 0.25mm. In an embodiment, the predefined thickness of the extensions 360 is 0.15mm. The predefined width of the extensions 360 may be smaller than, greater than or equal to the predefined width of the undulating struts 310. In an embodiment, the predefined width of the extensions 360 is the same as the predefined width of the undulating struts 310.
[0041] According to an embodiment, the extensions 360 are co-planar. For example, the extensions 360 reside in a plane, which is perpendicular to the longitudinal axis of the frame 200, and define a proximal side of the frame 200. In other words, the extensions 360 are at the proximal end 200a of the frame 200.
[0042] The frame 200 further includes a first row 315a of a plurality of first struts 315 as depicted in Fig. 4a. The first row 315a is provided circumferentially and may be oriented axially. The first row 315a includes the first struts 315 arranged circumferentially and connected to each other in a zig-zag pattern forming alternating peaks 315a1 and troughs 315a2. The peaks 315a1 are provided towards the proximal end 200a and the troughs 315a2 are provided towards the distal end 200b. According to an embodiment, a first end of each first strut 315 is coupled to a first end of a first adjacent first strut 315 to form the peak 315a1, making a predefined angle B1 ranging from 20 degrees to 40 degrees. In other words, two adjacent first struts 315 that are coupled to form one peak 315a1, make the predefined angle B1. In an embodiment, the predefined angle B1 is 30 degrees. According to an embodiment, a second end of each first strut 315 is coupled to a second end of a second adjacent first strut 315 to form the trough 315a2, making a predefined angle B2 ranging from 20 degrees to 40 degrees. In other words, two adjacent first struts 315 that are coupled to form one trough 315a2 make the predefined angle B2. In an embodiment, the predefined angle B2 is 30 degrees.
[0043] The plurality of first struts 315 may have a predefined structure, such as, wavy, straight, curved, etc. In an embodiment, the plurality of first struts 315 is wavy. The cross-section of the first struts 315 may be circular, rectangular, etc. In an embodiment, the cross-section of the first struts 315 is rectangular, having a predefined width ranging from 0.1mm to 0.4mm and a predefined thickness ranging from 0.1mm to 0.3mm. In an embodiment, the predefined width of the first struts 315 is 0.25mm. In an embodiment, the predefined thickness of the first struts 315 is 0.15mm. The length of each first strut 315 may range from 2mm to 20mm. In an embodiment, the length of the first strut 315 is 6mm. The predefined thickness, and predefined width of the first struts 315 may be smaller, greater or equal to the predefined thickness, and the predefined width, respectively, of the undulating struts 310. In an embodiment, the predefined thickness, and the predefined width of the first struts 315 is equal to the predefined thickness, and the predefined width, respectively of the undulating struts 310.
[0044] The first row 315a of the first struts 315 is coupled to the plurality of undulating struts 310. In an embodiment, each peak 315a1 of the first row 315a is coupled to a distal end of a corresponding undulating strut 310. More specifically, each peak 315a1 of the first row 315a is coupled to the second end of the second portion 310b of the corresponding undulating strut 310.
[0045] The frame 200 includes a plurality of first anchors 330 and a plurality of second anchors 345. The plurality of first anchors 330 and the plurality of second anchors 345 are configured to penetrate and attach to the surrounding tissue at a deployment location in the LAA (e.g., at the opening of the LAA). The first anchors 330 and the second anchors 345 are circumferentially arranged in the frame 200. In an embodiment, the first anchors 330 and the second anchors 345 are alternately disposed. For example, one first anchor 330 is followed by one second anchor 345 followed by one first anchor 330 and so on as depicted in Figs. 3a – 3b. In another example, two first anchors 330 are followed by two second anchors 345 followed by two first anchors 330 and so forth. Other variations for arranging the first anchors 330 and the second anchors 345 are also feasible and are considered within the scope of the present disclosure. Each of the first anchor 330 and the second anchor 345 is coupled to a corresponding trough 315a2 of the first row 315a.
[0046] Fig. 5a depicts one first anchor 330, according to an embodiment. Each first anchor 330 includes a proximal end 330a and a distal end 330b. In an embodiment, the proximal end 330a of the first anchor 330 is coupled to a corresponding first link 320. Each first anchor 330 includes a first slab 340 and one or more first spikes 335 (hereinafter, first spikes 335). The first slab 340 provides support to the first spikes 335. The first slab 340 extends from the proximal end 330a to the distal end 330b. A proximal end of the first slab 340 of the first anchor 330, is coupled to a corresponding trough 315a2 of the first row 315a using the first link 320 (as explained later). The first slab 340 may have a predefined shape, e.g., circular, rectangular, elliptical, diamond, rhombus, etc. In an embodiment, the first slab 340 is rectangular in shape, having a predefined width ranging from 0.4mm to 0.9mm and a predefined thickness ranging from 0.1mm to 0.3mm. In an embodiment, the predefined width of the first slab 340 is 0.7mm. In an embodiment, the predefined thickness of the first slab 340 is 0.15mm. A predefined length of the first slab 340 may range from 4mm to 10mm. In an embodiment, the predefined length of the first slab 340 is 5mm.
[0047] The first spikes 335 are configured to penetrate into and grip the surrounding tissue at the deployment location i.e., an annular wall of the LAA. The first spikes 335 protrude from the first slab 340 in a first direction. In an embodiment, the first spikes 335 project in a proximal direction towards the proximal end 200a of the frame 200, i.e., the first direction is the proximal direction, for example. The first spikes 335 may be cut out from the first slab 340, resulting in a corresponding slot 335a in the slab 340. The first spikes 335 protrude outward from the first slab 340 at a first predefined angle with respect to a longitudinal axis of the first slab 340. The first predefined angle may range between 30 degrees and 60 degrees. In an embodiment, the first predefined angle is 45 degrees. Each first spike 335 may have at least one edge coupled to the first slab 340. The first spikes 335 may have a predefined shape with at least one protruding vertex, such as, triangular, arrow, conical, pyramid, tapered, barbed, etc.
[0048] In an embodiment, the first spikes 335 are triangular having a first side 335b1, a second side 335b2, a third side 335b4 and a first protruding vertex 335b3 (hereinafter, the first vertex 335b3) defined by the first side 335b1 and the second side 335b2. The first side 335b1 and the second side 335b2 protrude away from the first slab 340 and third side 335b4 is coupled to the first slab 340. The first vertex 335b3 is configured to reside within the surrounding tissue of the LAA.
[0049] The first, second and third sides 335b1, 335b2, 335b4 may have the same or different lengths. In an embodiment, the first and second sides 335b1, 335b2 may have the same length, which is larger than the length of the third side 335b4. The first side 335b1, the second side 335b2 may have the length ranging from 0.4mm to 0.9mm, and the third side 335b4 may have the length ranging from 0.3mm to 0.7mm. In an embodiment, the length of the first and second sides 335b1, 335b2 is 0.7mm, and the length of the third side 335b4 is 0.5mm. The first spikes 335 have a predefined thickness ranging from 0.1mm to 0.3mm. In an embodiment, the thickness of the first spikes 335 is 0.15mm. The first vertex 335b3 has a predefined vertex angle C1 ranging from 30 to 50. In an embodiment, the predefined vertex angle ‘C1 of the first vertex 335b3 is 40. The number of first spikes 335 may be chosen based upon requirements. In an embodiment, two or more first spikes 335 may be provided on the first anchor 330. Preferably, the first anchor 330 includes between two and six first spikes 335. In an exemplary embodiment, each first anchor 330 includes three first spikes 335. It should be noted that less than or more than three first spikes 335 may be provided on the first anchor 330.
[0050] Fig. 5b depicts one second anchor 345, according to an embodiment. Each second anchor 345 includes a proximal end 345a and a distal end 345b. In an embodiment, the proximal end 345a of the second anchor 345 is coupled to a corresponding first link 320. Each second anchor 345 includes a second slab 355 and one or more second spikes 350 (hereinafter, second spikes 350). The second slab 355 provides support to the second spikes 350. The second slab 355 extends from the proximal end 345a to the distal end 345b. A proximal end of the second slab 355 is coupled to a corresponding trough 315a2 of the first row 315a using a first link 320.
[0051] The second slab 355 may have a predefined shape, e.g., circular, rectangular, elliptical, diamond, rhombus, etc. In an embodiment, the second slab 355 is rectangular in shape, having a predefined width ranging from 0.5mm to 0.9 and a predefined thickness ranging from 0.1mm to 0.3mm. In an embodiment, the predefined width of the second slab 355 is 0.7mm. In an embodiment, the predefined thickness of the second slab 355 is 0.15mm. A predefined length of the second slab 355 may range from 4mm to 10mm. In an embodiment, the predefined length of the second slab 355 is 5mm.
[0052] The second spikes 350 are configured to penetrate and grip the surrounding tissue at the deployment location, i.e., the annular wall of the LAA. The second spikes 350 protrude from the second slab 355 in a second direction. The second direction is opposite to the first direction. In an embodiment, the second spikes 350 project in a second direction towards the distal end 200b of the frame 200, i.e., the second direction is the distal direction, for example. The second spikes 350 may be cut out from the second slab 355, resulting in a corresponding slot 350a in the second slab 355. The second spikes 350 protrude outward from the second slab 355 at a second predefined angle with respect to a longitudinal axis of the second slab 355. The second predefined angle may range between 30 degrees and 60 degrees. In an embodiment, the second predefined angle is 45 degrees.
[0053] Each second spike 350 may have at least one edge coupled to the second slab 355. The second spike 350 may have a predefined shape with at least one protruding vertex, such as, triangular, arrow, conical, pyramid, tapered, barbed, etc. In an embodiment, the second spike 350 are triangular having a first side 350b1, a second side 350b2, a third side 350b4 and a first protruding vertex 350b3 (hereinafter, the first vertex 350b3) defined by the first side 350b1 and the second side 350b2. The first side 350b1 and the second side 350b2 protrude away from the second slab 355 and third side 350b4 is coupled to the second slab 355. The first vertex 350b3 is configured to reside within the surrounding tissue of the LAA. The first, second and third sides 350b1, 350b2, 350b4 may have the same or different lengths. In an embodiment, the first and second sides 350b1, 350b2 may have the same length, which is larger than the length of the third side 350b4.
[0054] The first side 350b1, the second side 350b2 may have the length ranging from 0.4mm to 0.9mm, and the third side 350b4 may have the length ranging from 0.3mm to 0.7mm. In an embodiment, the length of the first and second sides 350b1, 350b2 is 0.7mm, and the length of the third side 350b4 is 0.5mm. The second spikes 350 have a predefined thickness ranging from 0.1mm to 0.3mm. In an embodiment, the thickness of the second spikes 350 is 0.15mm. The first vertex 350b3 has a predefined vertex angle C2 ranging from 30 to 50. In an embodiment, the predefined vertex angle ‘C2 of the first vertex 350b3 is 40. The number of second spikes 350 may be chosen based upon requirements. In an embodiment, two or more second spikes 350 may be provided on the second anchor 345. Preferably, the second anchor 345 includes between two and six second spikes 350. In an exemplary embodiment, each second anchor 345 includes three second spikes 350. It should be noted that less than or more than three second spikes 350 may be provided on the second anchor 345.
[0055] The second spikes 350 of the second anchor 345 and the first spikes of the first anchor 330 project in the direction anti-parallel to each other, providing better grip with the surrounding tissue and minimizing the risk of migration of the implant 100. In other words, the first spikes 335 may project towards a first direction and the second spikes 350 may project towards a second direction, wherein the second direction is opposite to the first direction.
[0056] The frame 200 includes a plurality of first links 320 (hereinafter, the first links 320). In an embodiment, each of the first anchors 330 and the second anchors 345 is coupled to a respective trough 315a2 of the first row 315a using one first link 320. The first links 320 may have a predefined structure, such as, straight, curved, wavy, etc. In an embodiment, the first links 320 are straight. The cross-section of the first links 320 may be circular, rectangular, etc. In an embodiment, the cross-section of the first links 320 is rectangular, having a predefined width ranging from 0.1mm to 0.4mm and a predefined thickness ranging from 0.1mm to 0.3mm. In an embodiment, the width of the first links 320 is 0.25mm and the predefined thickness is 0.15mm. A predefined length of the first links 320 may range from 0.2mm to 0.8mm. In an embodiment, the predefined length of the first links 320 is 0.5mm. Each of the first links 320 includes a first end and a second end. The first end of the first link 320 is coupled to a corresponding trough 315a2 of the first row 315a and the second end of the first link 320 is coupled to one of the first anchor 330 or the second anchor 345. For example, the second end of the first link 320 is coupled to a proximal end of the first slab 340 of the respective first anchor 330 or the second slab 355 of the respective second anchor 345.
[0057] The frame 200 further includes a second row 405a of second struts 405. Optionally, the frame 200 may include a plurality of connectors 410 (hereinafter, connectors 410). Fig. 6 depicts the second row 405a and the connectors 410, according to an embodiment. The second row 405a is provided circumferentially. The second row 405a includes the second struts 405 are arranged circumferentially and connected to each other in a zig-zag pattern forming alternating peaks 405a1 and troughs 405a2. According to an embodiment, a first end of each second strut 405 is coupled to a first end of a first adjacent second strut 405 to form the peak 405a1, making a predefined angle D1 ranging from 20 degrees to 40 degrees. In other words, two adjacent second struts 405 that are coupled to form one peak 405a1 make the predefined angle D1. In an embodiment, the predefined angle D1 is 30 degrees.
[0058] According to an embodiment, a second end of each second strut 405 is coupled to a second end of a second adjacent second strut 405 to form the trough 405a2, making a predefined angle D2 ranging from 20 degrees to 40 degrees. In other words, two adjacent second struts 405 that are coupled to form one trough 405a2 make the predefined angle D2. In an embodiment, the predefined angle D2 is 30 degrees. In an embodiment, the second row 405a is co-planar, i.e., the second struts 405 are reside on the same plane. In an embodiment, the second struts 405 reside on a plane that is perpendicular to the longitudinal axis of the frame 200, thus, forming a distal side of the frame 200 as shown in Fig. 6. In this case, the peaks 405a1 are provided away from the longitudinal axis of the frame 200 and the troughs 315a2 are provided towards the longitudinal axis of the frame 200. In another embodiment, the second row 405a (i.e., the second struts 405) may be non-coplanar. For example, the second row 405a may be tapered, such that a diameter of the second row 405a decreases from a proximal end to a distal end of the second row 405a. In another example, the second row 405a (or the second struts 405) may be axially oriented (i.e., oriented parallel to the longitudinal axis of the frame 200).
[0059] The plurality of second struts 405 may have a suitable structure, such as, straight, wavy, curved, etc. In an embodiment, the plurality of second struts 405 are straight. The cross-section of the plurality of second struts 405 may be at least one of a circular, rectangular, etc. In an embodiment, the cross-section of the plurality of second struts 405 is rectangular, having a predefined width ranging from 0.1mm to 0.4mm and a predefined thickness ranging from 0.1mm to 0.3mm. In an embodiment, the predefined width of the plurality of second struts 405 is 0.25mm. In an embodiment, the predefined thickness of the plurality of second struts 405 is 0.15mm. The length of each second strut 405, ranges from 2mm to 18mm. In an embodiment, the length of the plurality of second struts 405 is 8mm. The predefined thickness, and predefined width of the second struts 405 may be smaller, greater or equal to the predefined thickness, and the predefined width, respectively, of the first struts 315. In an embodiment, the predefined thickness, and the predefined width of the second struts 405 is equal to the predefined thickness, and the predefined width, respectively of the first struts 315.
[0060] The second row 405a is coupled to the first anchors 330 and the second anchors 345. Specifically, each peak 405a1 of the second row 405a is coupled to a distal end of the first slab 340 of a respective first anchor 330 or a distal end of the second slab 355 of a respective second anchor 345. According to an embodiment, the second row 405a of the second struts 405 is coupled to the first anchors 330 and the second anchors 345 using a plurality of second links 325 (hereinafter, second links 325). Specifically, each peak 405a1 of the second row 405a is coupled to the distal end of the first slab 340 of the respective first anchor 330 or the distal end of the second slab 355 of the respective second anchor 345 using one second link 325.
[0061] The second links 325 may have a predefined structure, such as, straight, curved, wavy, etc. In an embodiment, the second links 325 are curved. The cross-section of the second links 325 may be circular, rectangular, etc. In an embodiment, the cross-section of the second links 325 is rectangular, having a predefined width ranging from 0.1mm to 0.4mm and a predefined thickness ranging from 0.1mm to 0.3mm. In an embodiment, the width of the second links 325 is 0.25mm and the predefined thickness is 0.15mm. The length of the second links 325 ranges from 0.5mm to 2mm. In an embodiment, the length of the second links 325 is 1mm. Each of the second links 325 includes a first end and a second end. The first end of the second links 325 is coupled to a corresponding peak 405a1 of the second row 405a and the second end of the second links 325 is coupled to one of the first anchor 330 (e.g., to the distal end of the first slab 340) or the second anchor 345 (e.g., to the distal end of the second slab 355).
[0062] The plurality of connectors 410 (hereinafter, connectors 410) is coupled to the second row 405a of the second struts 405. The connectors 410 are coupled to alternate pairs of adjacent second struts 405. In an embodiment, each connector 410 is configured to couple a pair of adjacent second struts 405. The connectors 410 provide flexibility to the implant 100, which helps in loading the implant 100 efficiently with the delivery catheter without breaking.
[0063] In an embodiment, each connector 410 includes two flared arms 410a defining one vertex 415. The connectors 410 may be, without limitation, V-shaped, C-shaped, U-shaped, etc. According to an embodiment, the connectors 410 are V-shaped. In an embodiment, each connector 410 is coupled to a corresponding pair of adjacent second struts 405. More specifically, each flared arm 410a of the connector 410 is coupled to one second strut 405 of the pair of adjacent second strut 405. In an embodiment, the flared arms 410a of each connector 410 are coupled to the troughs 405a2 of the second row 405a (shown in Fig. 6). Thus, each connector 410 is coupled to a pair of adjacent troughs 405a2 of the second row 405a.
[0064] The length of the flared arms 410a of the connector 410 may range from 5mm to 15mm. In an embodiment, the length of the flared arms 410a is 10mm. The flared arms 410a may subtend a predefined angle ‘D3’ at the vertex 415 ranging from 20 degrees to 40 degrees. In an embodiment the predefined angle ’D3’ is 30 degrees. The cross-section of the connectors 410 may be one of circular, rectangular, etc. In an embodiment, the cross-section of the connectors 410 is rectangular, having a predefined width ranging from 0.1mm to 0.4mm and a predefined thickness ranging from 0.1mm to 0.3mm. In an embodiment, the predefined width of the connectors 410 is 0.25mm. In an embodiment, the predefined thickness of the connectors 410 is 0.15mm. The predefined width of the connector 410 may be smaller than, greater than or equal to the predefined width of the second struts 405. In an embodiment, the predefined width of the connector 410 is the same as the predefined width of the second struts 405.
[0065] In an embodiment, the thickness of the vertex 415 is more than the thickness of the flared arms 410a. In an embodiment, the connectors 410 are co-planar, e.g., the connectors 410 reside on a plane that is perpendicular to the longitudinal axis of the frame 200. In another embodiment, the connectors 410 may be non-coplanar.
[0066] In an embodiment, the vertex 415 of the connector 410 projects towards the longitudinal axis of the frame 200. In an embodiment, the vertices 415 of the connectors 410 define a hole 425. The hole 425 provides flexibility to the implant 100 and facilitate a smaller radial profile of the implant 100 when crimped, which helps in loading the implant 100 in the delivery catheter. The peaks 405a1 are provided away from the hole 425 and the troughs 315a2 are provided towards the hole 425.
[0067] Each connector 410 may optionally include one or more protrusions 420. The protrusions 420 helps the implant 100 to regain its shape. In an embodiment, each connector 410 includes one protrusion 420. The protrusions 420 extend away from the vertex 415 towards the proximal end 200a of the frame 200, defining a predefined length ranging from 0.02mm to 0.06mm. In an embodiment, the predefined length of the protrusions 420 is 0.04mm. The protrusions 420 may have a suitable cross-section such as, rectangular, rounded, etc. In an embodiment, the cross-section of the protrusions 420 is rectangular, defining a predefined width ranging from 0.01mm to 0.06mm and a predefined thickness ranging from 0.1mm to 0.4mm. In an embodiment, the predefined width of the protrusion 420 is 0.05mm. In an embodiment, the predefined thickness of the protrusion 420 is 0.15mm.
[0068] The membrane 500 is made of a biocompatible material, such as, without limitation, PET (polyethylene-terephthalate), PTFE (Polytetrafluoroethylene), etc. In an embodiment, the membrane 500 is made of PET. The membrane 500 may have a predefined pattern such as, mesh, zig-zag, etc. In an embodiment, the membrane 500 is in the form of a mesh. The membrane 500 includes a plurality of micropores of uniform size. The membrane 500 is coupled with the outer surface of the frame 200 for at least a partial length of the frame 200. In an embodiment, the membrane 500 is coupled with the outer surface of the frame 200 for a partial length of the frame 200. In an embodiment, the membrane 500 is coupled to the tubular section 305, undulating struts 310, the first row of first struts 315, the first links 320, the first anchors 330 and the second anchors 345. The first spikes 335 and the second spikes 350 protrude out of the membrane 500. The membrane 500 may be coupled to the frame 200 using, for example, suturing, bonding, etc. In an embodiment, the membrane 500 is sutured with the frame 200 in a predefined pattern (e.g., interrupted, continuous, appositional, etc.) using sutures of a desired material. The material of the sutures may include without limitation, Polypropylene, Polyethylene terephthalate, etc. The membrane 500 facilitates tissue generation on the implant 100, providing a seal and preventing the passage of blood through the implant 100, thus, closing or occluding the LAA.
[0069] Fig. 7 depicts a flowchart of a method 600 for deployment of the implant 100 at the implanted location. The method 600 may be performed under an imaging guidance system, e.g., under fluoroscopy guidance. At step 602, navigating an introducer sheath to the left atrium of the heart. According to an embodiment, the femoral vein is punctured and the sheath is inserted into the femoral vein. The introducer sheath is advanced through the patient’s vasculature to the right atrium and then to the left atrium of the heart. At step 604, the implant 100 is delivered at a deployment site. In an embodiment, the delivery catheter, loaded with the implant 100, is advanced through the introducer sheath into the left atrium. As explained earlier, the female threads 305c1 of the jacket 305c in the lumen 305b of the tubular section 305, couple to the male threads of the delivery cable.
[0070] Once the delivery catheter reaches a desired position, the implant 100 is exposed inside the left atrium, by pulling the delivery catheter. Due to the self-expanding characteristics, the implant 100 radially expands to a fully expanded state. The delivery catheter is carefully maneuvered to position the implant 100 at the opening of the LAA. The implant 100 is positioned such that the tubular section 305 of the implant 100 is positioned at the opening of the LAA, and the first spikes 335 and the second spikes 350 penetrate through the tissue surrounding the opening of the LAA. The implant 100 remains attached to the delivery cable at this stage.
[0071] At step 606, the device is assessed based upon the one or more parameters. In an embodiment, the position of the device is assessed using, for example, fluoroscopy. Further, occlusion (or sealing) performance of the implant 100 is assessed using, for example, echocardiography. The implant 100 remains engaged with the delivery catheter at this stage. If the surgeon is not satisfied with the position and/or occlusion provided by the implant 100, the position of the implant 100 may readjusted with the help of the delivery catheter. At step 608, once the surgeon is satisfied with the position and the occlusion, the implant 100 is released at the deployment site. More specifically, the female threads 305c1 of the jacket 305c of the implant 100 are decoupled from the male threads of the delivery cable. Figs. 2a and 2b illustrate the implant 100 deployed at the target deployment site.
[0072] Fig. 8 depicts a flowchart of a method 700 for manufacturing the implant 100. At step 702, a tube made of a biocompatible, shape memory (i.e., self-expanding) material is laser cut according to a structure of the frame 200. The dimensions (e.g., length, thickness, and diameter) of the tube may be chosen based upon the size of the implant 100. In an embodiment, the length of the tube may range from 1m to 10m, the diameter of the tube may range from 2 mm to 10mm and the thickness of the tube may range from 0.1mm and 0.3mm. In an exemplary embodiment, a tube made of nitinol and having the length of 2m, the diameter of 3.2mm and the thickness of 0.15mm is laser cut. The tube may be laser cut using, for example, a femtosecond laser, a continuous wave laser, a nanosecond laser, etc. In an embodiment, a femtosecond laser is used to cut the tube. The laser may be of a predefined power chosen based upon required cutting depth, e.g., the predefined power may range from 10 W to 50 W. In an exemplary embodiment, the predefined power is 20 W. In an embodiment, a pulse duration of the laser pulses is less than 10 ns to achieve ultra-fine cuts. The cutting speed may range from 100 mm/min to 5000 mm/min. In an exemplary embodiment, the cutting speed is 500 mm/min.
[0073] At step 704, the frame 200 is subjected to a shape setting process to achieve a desired shape. In an embodiment, the frame 200 obtained at step 702 is placed inside a mold and is heated at a predefined temperature for a predefined time. The mold has grooves designed according to the desired pattern of the frame 200 (e.g., as depicted in Figs. 3a – 3b). In an embodiment, the predefined temperature ranges from 500 degrees to 600 degrees and the predefined time ranges from 1 min to 30 min. In an embodiment, the frame 200 is heated to 505 degrees for 5 mins. The frame 200 is then quenched to a room temperature to retain the desired shape and mechanical properties.
[0074] At step 706, the frame 200 is subjected to an electropolishing process. This step is performed to remove surface imperfections. In an embodiment, the frame 200 is submerged in an electrolytic solution for a predefined duration ranging from 1 min to 5 min. A predefined voltage ranging from 10V to 20V and a predefined current density ranging from 0.1 A/cm2 to 1 A/cm2 is used for electropolishing. In an exemplary embodiment, the predefined voltage and the predefined current density is 15V & 0.5 A/cm2, respectively. Further, in an exemplary embodiment, a mixture of Perchloric acid and Acetic acid is used as the electrolytic solution. It should be understood that any other suitable electrolytic solution may also be used.
[0075] At step 708, the membrane 500 is sutured to the frame 200. In exemplary embodiment, the membrane 500 is sutured to the frame 200 in continuous pattern using a suture made of Polyethylene terephthalate. In an embodiment, the membrane 500 is made of a PET film having a plurality of micropores. The membrane 500 may be manufactured using, for example, track-etching process, or anodic aluminum oxide (AAO) process. According to an exemplary embodiment, the membrane 500 is manufactured using precise, controlled track-etching process. In an embodiment, a smooth, biaxially-oriented PET film is formed using melt extrusion and stretching. The PET film thus formed is then irradiated. For example, the PET film is bombarded with high-energy heavy ions (such as, krypton, xenon or argon ions) to form an irradiated film. In an embodiment, the irradiation process uses Krypton ions. This process creates latent damage tracks through the polymer matrix of the PET film. Thereafter, the irradiated film is subjected to a chemical etching process to develop these tracks into micropores. In an embodiment, the irradiated film is immersed in a chemical etchant at a predefined temperature (e.g., ranging from 50 degree C to 100 degree C) for a predefined duration (e.g., ranging from 15 mins to 2 hours). The predefined temperature and duration are chosen based upon desired pore size. In an embodiment, the predefined time and predefined temperature is 60 degree C and 30 mins, respectively. The chemical etchant may at least one of: sodium hydroxide (NaOH), potassium hydroxide (KOH), etc. In an embodiment, the chemical etchant is sodium hydroxide at a predefined concentration ranging from 4N to 7N. In an embodiment, the concentration of NaOH is 6N.
[0076] The device of the present disclosure offers several advantages over the conventional devices. The proposed device includes a frame and a membrane. The frame includes plurality of first anchors and second anchors. The first and the second anchors are arranged in opposite directions, providing a more secure grip to the surrounding tissue at the implanted site as compared to the conventional devices. Thus, the proposed implant mitigates the risk of migration of the implant from its implanted sites, avoiding related complications. Further, the structure of the frame is designed to provide strength to the implant and hold the membrane efficiently, eliminating the chances of leakage of the blood through the implant.
[0077] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM
1. An implant (100) for closing the left atrial appendage (LAA), the implant (100) comprising:
a. a frame (200) comprising:
i. a tubular section (305);
ii. a plurality of undulating struts (310) arranged circumferentially and extending radially outward from the tubular section (305);
iii. a first row (315a) of first struts (315) connected to each other to form alternating peaks (315a1) and troughs (315a2), each of the peaks (315a1) of the first row (315a) is coupled to a distal end of a corresponding undulating strut (310);
iv. a plurality of first anchors (330) arranged circumferentially, each first anchor (330) comprising: a first slab (340) coupled to a corresponding trough (315a2) of the first row (315a); and one or more first spikes (335) protruding from the first slab (340) in a first direction and configured to penetrate an annular wall of the LAA;
v. a plurality of second anchors (345) arranged circumferentially, each second anchor (345) comprising: a second slab (355) coupled to a corresponding trough (315a2) of the first row (315a); and one or more second spikes (350) protruding from the second slab (355) in a second direction and configured to penetrate an annular wall of the LAA, the second direction being opposite to the first direction; and
vi. a second row (405a) of second struts (405) connected to each other to form alternating peaks (405a1) and troughs (405a2), each of the peaks (405a1) of the second row (405a) is coupled to the first slab (340) of a respective first anchor (330) or to the second slab (355) of a respective second anchor (345).
2. The implant (100) as claimed in claim 1, wherein the frame (200) comprises a plurality of extensions (360) extending towards a longitudinal axis of the frame (200), each extension (360) configured to couple an alternate pair of adjacent undulating struts (310).
3. The implant (100) as claimed in claim 2, wherein each extension (360) comprises two flared arms (360a) defining a vertex (360b) disposed towards the longitudinal axis of the frame (200), each flared arm (360a) coupled to one undulating strut (310) of a corresponding pair of adjacent undulating struts (310).
4. The implant (100) as claimed in claim 1, wherein each undulating strut (310) comprises:
a. a first portion (310a) having a first end coupled to the tubular section (305), and a second end, the first portion (310a) comprising:
i. a first arm (310a1) coupled to the tubular section (305) and extending towards the distal end (200b) of the frame (200);
ii. a second arm (310a2); and
iii. a connecting portion (310a3) coupling the first arm (310a1) and the second arm (310a2);
wherein the second arm (310a2) extends from the connecting portion (310a3) towards a proximal end (200a) of the frame (200); and
b. a second portion (310b) extending from the second end of the second arm (310a2) towards the distal end (200b) of the frame (200) and making a predefined angle ‘A’.
5. The implant (100) as claimed in claim 4, wherein the second arm (310a2) of the first portion (310a) extends in a proximal direction to the proximal end (200a) of the frame (200) such that the second end of the first portion (310a) aligns with a proximal end of the tubular section (305).
6. The implant (100) as claimed in claim 4, wherein the predefined angle ‘A’ ranges from 70 degrees to 120 degrees.
7. The implant (100) as claimed in claim 1, wherein the tubular section (305) comprises one or more apertures (305a) provided on a curved surface of the tubular section 305.
8. The implant (100) as claimed in claim 1, a proximal end of each undulating strut (310) is coupled to a distal end of the tubular section (305).
9. The implant (100) as claimed in claim 1, wherein the plurality of first anchors (330) and the plurality of second anchors (345) are alternately disposed.
10. The implant (100) as claimed in claim 1, wherein the first slab (340) of each first anchor (330) and the second slab (355) of each second anchor (345) are coupled to the respective trough (315a2) of the first row (315a) using a first link (320).
11. The implant (100) as claimed in claim 1, wherein the first slab (340) of each first anchor (330) and the second slab (355) of each second anchor (345) are coupled to the respective peak (405a1) of the second row (405a) using a second link (325).
12. The implant (100) as claimed in claim 1, wherein the frame (200) comprises a plurality of connectors (410) extending towards a longitudinal axis of the frame (200), each connector (410) configured to couple an alternate pair of adjacent troughs (405a2) of the second row (405a), each connector (410) comprising two flared arms (410a) defining a vertex (415) disposed towards the longitudinal axis of the frame (200), each flared arm (410a) coupled to one trough (405a2) of a corresponding pair of adjacent troughs (405a2) of the second row (405a).
13. The implant (100) as claimed in claim 12, wherein each connector (410) comprises one or more protrusions (420) extending from the vertex (415) towards a proximal end (200a) of the frame (200).
14. The implant (100) as claimed in claim 1, wherein the frame (200) is laser-cut from a single tube made of a biocompatible, self-expanding material.
15. The implant (100) as claimed in claim 1, wherein the implant (100) comprises a membrane (500) coupled to the frame (200).