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:
OCCLUSION 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 THE INVENTION
[001] The present disclosure relates to a medical device. More specifically, the present disclosure relates to an occlusion device used to occlude apertures, or orifices of vascular tissues.
BACKGROUND OF THE INVENTION
[002] The heart is the principal organ of the blood circulatory system. The four compartments (chambers) of the heart contract in a rhythmic manner to circulate (or pump) blood throughout the body. The Left Atrial Appendage (LAA) is a small ear-shaped sac-like structure present in the muscular wall of the left atrium (top left chamber of the heart). During a normal cardiac cycle, the LAA contracts along with the left atrium, to pump blood out from the LAA, thereby preventing the blood from stagnating within the LAA.
[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 atrium. In patients with arrhythmia such as Atrial Fibrillation (AFib or AF), the LAA may fail to contract sufficiently and pump the blood out of the LAA. Any stagnant amount of blood within the LAA is susceptible to coagulation resulting in the formation of a thrombus (or clots). The thrombus may dislodge from within the LAA and enter into the bloodstream leading to a transient ischemic attack, a stroke, or a blood vessel blockage called an embolism.
[004] To prevent the above condition, a percutaneous Left Atrial Appendage Occlusion (LAAO) procedure also known as a Left Atrial Appendage Closure (LAAC) procedure may be performed. The LAAC procedure is a minimally invasive procedure used to reduce the risk of blood clots leaving the left atrial appendage and entering the bloodstream. In the LAAC procedure, a Left Atrial Appendage Closure (LAAC) device is implanted at an orifice of the LAA generally by a catheterization process.
[005] However, the conventionally available LAAC devices fail to fully occlude the LAA, thereby allowing a potential risk of peri-device leakage from around the implanted LAAC device. Further, these LAAC devices fail to properly anchor to the slippery walls of the LAA. Poor anchorage of the conventional LAAC device creates difficulties in correct positioning of the LAAC device during the deployment procedure and potential risk of migration after the deployment procedure.
[006] Thus, there is a need for an improved LAAC device that overcomes the aforementioned challenges associated with the conventional LAAC devices.
SUMMARY OF THE INVENTION
[007] 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.
[008] The present disclosure relates to a device including a proximal end, a distal end, a frame, at least one linker, and a membrane cover. The frame is made of a plurality of struts arranged circumferentially. Each of the struts of the plurality of struts extends from the proximal end to the distal end. The at least one linker is coupled to at least one pair of adjacently disposed struts. The membrane cover is disposed at least partially over at least one of an outer surface or an inner surface of the frame.
BRIEF DESCRIPTION OF THE DRAWINGS
[009] The summary above, as well as the following detailed description of the 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.
[010] Fig. 1 and 1a depict various views of a cross-section of the human heart 1 with a device 100 being implanted inside the LAA 1a of the heart 1 in accordance to an embodiment of the present disclosure.
[011] Fig. 2 depicts a layer of epithelial cells on an outer surface of the device 100 implanted inside the LAA 1a in accordance with an embodiment of the present disclosure.
[012] Fig. 3 depicts the device 100 in accordance with an embodiment of the present disclosure.
[013] Fig. 4 depicts a frame 120 of the device 100 in accordance with an embodiment of the present disclosure.
[014] Fig. 4a depicts a top view of the frame 120 of the device 100 in accordance with an embodiment of the present disclosure.
[015] Fig. 5a depicts a top-perspective side view and Fig. 5b depicts a bottom perspective side view of the frame 120 of the device 100 in accordance with an embodiment of the present disclosure.
[016] Fig. 6 depicts a proximal view of the device 100 in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[017] 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 with”, as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, coupled 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.
[018] References 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 “a,” “an,” and “the” also refer to “one or more” unless expressly specified otherwise.
[019] 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.
[020] 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.
[021] The present disclosure discloses an occlusion device (or device). The device may be used for closure of a vascular orifice (i.e., a target site). In an exemplary embodiment, the vascular orifice is the entrance (or ostium) of the Left Atrial Appendage (LAA) of the heart. The device easily conforms to different anatomies of the LAA.
[022] The device of the present disclosure includes a self-expandable frame with a membrane cover provided over at least one of an outer surface and inner surface of the frame. The frame helps the device to conform to the natural contours of the target site (i.e., the LAA). This ensures effective occlusion of the LAA. The membrane cover is impermeable to passage of blood from the left atria into the LAA. Thus, the device effectively occludes the LAA and prevents peri-device leakage from around the device.
[023] The device of the present disclosure is provided with one or more anchor elements that help to anchor the device with the surrounding tissue of the vascular orifice thereby, preventing migration of the device and providing long-term stability to the device. Post-implantation, the device promotes reendothelialization (namely, a process of formation of a new layer of endothelial cells) over at least a portion of the device. The reendothelialization reinforces the sealing effect provided by the device, thereby preventing the blood clots to enter the blood stream from within the LAA.
[024] 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).
[025] 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.
[026] 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 shaft 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 shaft 210) out of the delivery sheath 200. The delivery shaft 210 is then decoupled from the device 100 and withdrawn along with the delivery sheath 200.
[027] 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.
[028] 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.
[029] Fig. 2 depicts the device 100 implanted inside the LAA 1a. A layer of endothelial cells 3 supported by at least a portion of the device 100 helps to completely seal off the LAA 1a, thereby preventing the blood clots to enter the blood stream from within the LAA 1a.
[030] Fig. 3 depicts an exemplary embodiment of the device 100 of the present disclosure. The device 100 includes a proximal end 100a, a distal end 100b, a frame 120 extending there between, and a membrane cover 190 disposed at least partially over the frame 120. The proximal end 100a as well as the distal end 100b of the device 100 are close ended. In other words, close ended refers to an end which does not include an opening.
[031] Fig. 4 depicts the frame 120 of the device 100, according to an exemplary embodiment of the present disclosure. The frame 120 may be dimensioned basis the anatomy of the LAA 1a. The frame 120 may be made of one or more shape-memory materials including, but not limited to, stainless steel, nickel-titanium alloys, tantalum, cobalt-chromium alloys, magnesium alloys, etc. In an exemplary embodiment, the frame 120 is made of nickel-titanium alloys (nitinol). The shape-memory material of the frame 120 enables the frame 120 (and the device 100) to self-expand from the radially collapsed state to the radially expanded state at the time of implantation.
[032] Alternatively, the frame 120 may be made of one or more polymeric materials including, but not limited to, polyethylene, polyurethanes, polyglycolic acid, polylactic acid, 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 120 is expanded using an external mechanism.
[033] The frame 120 (and the device 100) may have a predefined shape, such as, without limitation, cylindrical, conical, crown, spherical, etc. In an exemplary embodiment, as shown in Fig. 4, the shape of the frame 120 of the device 100 is substantially spherical.
[034] The substantially spherical shape of the frame 120 of the device 100 provides enhanced flexibility, and strength which allows the device 100 to conveniently pass through the tortuous vasculature for deployment. The frame 120 may include a length ranging from 10 mm to 20mm. In an exemplary embodiment, the length of the frame 120 is 15 mm.
[035] The frame 120 includes a plurality of struts 130, at least one linker 140 and one or more anchor elements 150. The struts 130, the linker 140 and the anchor elements 150 may be discrete components of the frame 120 or may form an integral structure of the frame 120. In an exemplary embodiment, the struts 130, the linker 140 and the anchor elements 150 are integrally formed by laser cutting a tube (not shown).
[036] The struts 130 extend from the proximal end 100a to the distal end 100b of the frame 120. The struts 130 may be one of radially curved, substantially straight, at least partially wavy, or a combination thereof. The struts 130 may have a circular cross-section or a non-circular cross-section. Each of the strut 130 of the frame 120 has a predefined length, and a predefined thickness and a predefined width. The predefined length of the strut 130 may vary with the dimensions of the frame 120. The predefined thickness and width of the struts 130 may range between 100 mm and 250 mm, and 100 mm and 300 mm, respectively. In an exemplary embodiment, the predefined thickness and the predefined width of each of the strut 130 is 200 mm and 250 mm, respectively.
[037] The struts 130 of the frame 120 may be made of one or more self-expanding or polymeric materials. The self-expanding material may include, without limitation, stainless steel, nickel-titanium alloys, tantalum, cobalt-chromium alloys, magnesium alloys, etc., or a combination thereof. The polymeric material may include, without limitation, polyethylene, polyurethane, polyglycolic acid, polylactic acid, etc., or a combination thereof. In an exemplary embodiment, the struts 130 is made up of nickel-titanium alloys (Nitinol) alloy.
[038] The struts 130 of the frame 120 may be arranged in a predefined pattern which may be, without limitation, spiral, twisted, curve, Fibonacci curve, swirl, hyperbolic, parabolic, etc. Alternately, the struts 130 of the frame 120 are arranged circumferentially and equidistantly from each other.
[039] In an exemplary embodiment, as shown in Fig. 4, the struts 130 are spirally arranged like a Fibonacci curve to form the frame 120. The struts 130 have a curved profile, thereby defining a bend angle between the struts 130 and a respective plane defined by the proximal end 100a and the distal end 100b of the device 100. The bend angle ranges from 15° to 60°. In an exemplary embodiment, the bend angle is 30⁰.
[040] The pattern and the arrangement of the struts 130 gives a firm shape to the frame 120. In other words, the substantially spherical shape of the frame 120 is formed by the precise arrangement of the struts 130 as well as the predefined configuration of the struts 130 extending from the proximal end 100a to the distal end 100b. The resulting arrangement of the struts 130 is a cage-like configuration which, helps the frame 120 (and the device 100) to conform to the natural contours of the LAA 1a. This ensures effective occlusion of the LAA 1a. Further, the substantially spherical shape of the frame 120 helps in distributing pressure evenly against the walls of the orifice, which minimizes the risk of tissue damage.
[041] The struts 130 that are disposed adjacent to each other, are interconnected via at least one linker 140 as shown in Fig. 4, Fig. 5a and Fig. 5b. The linkers 140 may be V-shaped, Y-shaped. In an exemplary embodiment, as shown in Fig. 4, the linkers 140 has inverted V-shape.
[042] At least one row of linkers 140 may be provided circumferentially with the frame 120. In the exemplary depicted embodiment, as shown in Fig. 4, two rows of linkers 140, namely a first row 140a and a second row 140b, are provided with the frame 120. The two rows of linkers 140 help the device 100 to accommodate variations in the size/anatomy of the LAA 1a to provide a secure fit of the device 100 at the LAA 1a, ensuring complete sealing of the LAA 1a. In another exemplary embodiment, not shown, only one row of linkers 140, namely the first row 140a or the second row 140b, is provided with the frame 120. In another exemplary embodiment, not shown, only three rows of linkers 140 is provided with the frame 120.
[043] The first row 140a of the linkers 140 may be disposed between two adjacently disposed struts 130, thereby connecting the two struts 130. In an embodiment, the first row 140a of the linkers 140 is provided centrally. The second row 140b of the linkers 140 may be relatively closer to the distal end 100b of the frame 120 than the first row 140a of the linkers 140. Alternatively, the second row 140b of the linkers 140 may be relatively closer to the proximal end 100a of the frame 120 than the first row 140a of the linkers 140. It is to be noted that the above are exemplary dispositions of the linkers and the same can be placed as required for better sealing. In an exemplary embodiment, the first row 140a of the linkers 140 includes 6 linkers 140 while the second row 140b of the linkers 140 includes 6 linkers 140. The number of linkers 140 of the frame 120 may vary depending upon the number of the struts 130 and/or the size of the frame 120.
[044] In an exemplary embodiment, as shown in Fig. 4, the linkers 140 of the first row 140a are disposed alternatively relative to the linkers 140 of the second row 140b. The linkers 140 may be made of one or more metallic materials, such as, without limitation, nitinol, stainless steel, tantalum, cobalt-chromium alloy, etc. Alternatively, the linkers 140 may be made of one or more polymeric materials including, but not limited to, polyethylene, polyurethanes, polyglycolic acid, polylactic acid, etc. In an exemplary embodiment, the linkers 140 are made of nitinol.
[045] The linkers 140 are configured to dynamically adapt to the changes in the frame’s 120 dimensions, ensuring consistent support and maintain the structural integrity of the frame 120 during both radial expansion and radial collapse. In other words, the linkers 140 are configured to expand or contract (along with the struts 130) for accommodating the radial expansion or radial collapse of the frame 120.
[046] In an exemplary embodiment, an angle of the linkers 140 with the struts 130 increases to accommodate the expansion of the frame 120. And, the angle of the linkers 140 with the struts 130 decreases to accommodate the collapse of the frame 120.
[047] The anchor elements 150 of the frame 120 extends away from the frame 120. The number of anchor elements 150 provided on the frame 120 may vary depending upon the number of the struts 130 and/or the number of the linkers 140. In an exemplary embodiment, the frame 120 includes six anchor elements 150. The anchor elements 150 are coupled to at least one of the first row 140a and the second row 140b of the linkers 140 using techniques, such as, without limitation, welding, crimping, soldering, brazing, laser welding, UV bonding, gluing, Spot welding, etc. In an exemplary embodiment, the anchor elements 150 are coupled to the linkers 140 using laser welding.
[048] Additionally or optionally, the anchor elements 150 are coupled to the struts 130 of the frame 120 (not shown).
[049] The anchor elements 150 provided on the first row 140a and the second row 140b of the linkers 140 are configured to engage with the surrounding tissue of the vascular orifice. The anchor elements 150 help to completely seal off the LAA 1a thereby, reducing the risk of per-device leakage. It also facilitates more precise deployment and positioning of the device 100, ensuring optimal closure. This prevents dislodgement/migration of the device 100 from the LAA 1a, thereby providing long-term stability to the device 100 post-deployment.
[050] The anchor elements 150 of the frame 120 may be one of V-shaped, Y-shaped, J-shaped, etc. In an exemplary embodiment as depicted in Figs. 3, 4 and 4a, the anchor elements 150 are J-shaped. It is to be noted that the anchor element 150 may have any suitable shape, provided that the functionality of the anchor element 150 is achieved without departing from the scope of the teachings of the present disclosure. The anchor elements 150 may be made of one or more materials including but not limited to nitinol, stainless steel, tantalum, cobalt, chromium, DFT Wire, PDO Suture, etc. In an exemplary embodiment, the anchor elements 150 are made of Nitinol.
[051] The frame 120 includes at least one of a first hub 160 and a second hub 170, as shown in Fig. 5a and Fig. 5b. The first hub 160 is provided towards the proximal end 100a. And, the second hub 170 is provided towards the distal end 100b. The first hub 160 and the second hub 170 may be made of one or more biocompatible materials, such as without, limitation, nitinol, stainless steel, tantalum, cobalt, chromium. In an exemplary embodiment, the at least one hub is made of stainless steel. The first hub 160 and the second hub 170 are disposed inside the frame 120 which helps prevent the risk of formation of thrombus on the surface of the first hub 160 and the second hub 170. Alternatively, the first hub 160 and the second hub 170 may be disposed outside the frame 120.
[052] At the proximal end 100a of the device 100, at least a portion of the struts 130 converge towards the first hub 160 and coupled thereto. At the distal end 100b of the device 100, at least a portion of the struts 130 converge towards the second hub 170 and are coupled thereto. The struts 130 may be coupled to the first hub 160 and the second hub 170 using techniques, such as, without limitation, welding, crimping, soldering, brazing, laser welding, UV bonding, gluing, Spot welding. In an exemplary embodiment, the struts 130 are coupled to the first hub 160 and the second hub 170 using laser welding.
[053] The first hub 160 is disposed at the proximal end 100a of the frame 120 defining a bulge at the proximal end 100a. The bulge provides a convex-like structure to the proximal end 100a of the frame 120 which helps in uniform radial force distribution and proper expansion of the device 100 and provides complete occlusion of the LAA 1a to prevent per-device leak.
[054] The second hub 170 may be disposed at a pre-defined distance away from the distal end 100b of the device 100, such that the distal end 100b of the device 100 defines a concave indentation extending towards the inside of the frame 120. The pre-defined distance ranges from 1 mm to 6 mm. In an exemplary embodiment, the pre-defined distance is 3 mm. The indentation formed at the distal end 100b of the frame 120 helps in uniform radial force distribution and proper expansion of the device 100 and wall apposition.
[055] The membrane cover 190 may be at least partially disposed over at least one of an inner surface and the outer surface of the frame 120. In an exemplary embodiment, as shown in Fig. 3, the membrane cover 190 is disposed over the outer surface of the frame 120. The membrane cover 190 is configured to prevent the release of blood clots from the vascular orifice i.e., the LAA 1a to the bloodstream, thereby preventing thromboembolism. The membrane cover 190 extends from the proximal end 100a of the frame 120 to at least one of the linkers 140 of the device 100. In an exemplary embodiment, as shown in Fig. 3, the membrane cover 190 extends from the proximal end 100a to the second row 140b of the linkers 140 and encapsulating the first row 140a of the linkers 140. The anchor elements 150 are configured to extend across the membrane cover 190. In another exemplary embodiment, the membrane cover 190 extends from the proximal end 100a to the first row 140a of the linkers 140. The membrane cover 190 promotes reendothelialization post-implantation of the device 100 at the LAA 1a as shown in Fig. 2. This helps the device 100 to integrate with the surrounding tissue and form a smooth, continuous surface that mimics the natural lining of the heart 1.
[056] The membrane cover 190 may be made of one or more materials, such as, without limitation, polyethylene terephthalate (PET), polyester, polytetrafluoroethylene (PTFE) expanded polytetrafluoroethylene (ePTFE), etc. In an exemplary embodiment, the membrane cover 190 is made of PET. The membrane cover 190 is coupled to the frame 120 using techniques, such as, without limitation, stitching, glueing, bonding, hook, etc. In an exemplary embodiment, the membrane cover 190 is coupled to the frame 120 using stitching.
[057] The membrane cover 190 may be coated with one or more layers of a coating including, without limitation, anti-thrombotic coating, Hydrophilic coating, antimicrobial coatings, or a combination thereof. In an exemplary embodiment, the membrane cover 190 includes an anti-thrombotic (or anti-coagulant) coating. The antithrombotic coating on the device 100 is provided to reduce the risk of blood clot formation on the surface of the device 100. The anchor elements 150 of the second row 140b of the linkers 140 of the frame 120 at least partially help in the attachment of the membrane cover 190 to the frame 120 and ensure that the membrane cover 190 remains intact and in place, covering the opening of the LAA 1a.
[058] During a medical procedure, the device 100 of the present disclosure may be implanted at the LAA 1a using a minimally invasive technique, such as trans-catheterization. The trans-catheterization or transcatheter delivery of the device 100 is carried out by using a delivery catheter or sheath 200 as shown in fig. 1 and 1a.
[059] The device 100 is pre-loaded in the delivery catheter/sheath 200. In an exemplary embodiment, a distal end of a delivery shaft 210 may be coupled to the proximal end 100a of the device 100 as shown in Fig. 1a. The delivery shaft 210 is movably disposed within the delivery sheath 200. In an exemplary embodiment, a hole 180 is provided within the first hub 160 disposed towards the proximal end 100a of the frame 120, as shown in Fig. 6. The hole 180 on the proximal end 100a of the frame 120 includes a plurality of internal threads. The internal threads of the hole 180 are configured to mate with a plurality of external threads on an outer surface of the delivery shaft 210 of the delivery sheath 200 to couple the delivery shaft 210 to the device 100.
[060] In yet another embodiment, the proximal end 100a of the frame 120 is provided with a protrusion (not shown). The protrusion may include a plurality of external threads configured to mate with a plurality of internal threads provided inside the delivery shaft 210. The screw-type mechanism ensures easy attachment/detachment of the device 100 with the delivery shaft 210 and prevents shear failure or slipping of the device 100 with respect to the delivery shaft 210 during loading and deployment of the device 100.
[061] During the medical procedure, the delivery shaft 210 coupled to the device 100 is loaded inside of the delivery catheter/sheath 200 and is minimally advanced into the patient’s body via a pre-defined vascular access point, e.g., through the transfemoral groin of a patient. The delivery catheter/ sheath 200 is navigated to the target site (i.e., LAA 1a of the heart 1) as shown in Fig. 1 and 1a with the help of a guide wire (not shown). Fluoroscopic imaging techniques may be used to guide and monitor the advancement of the delivery catheter/sheath 200 during the procedure.
[062] Once the catheter/sheath approaches the LAA 1a, the delivery catheter sheath 200 is withdrawn by keeping the delivery shaft 210 stationary. Alternatively, the delivery shaft 210 is pushed out of the delivery catheter 200 by keeping the delivery catheter 200 stationary. Relatively pushing the device 100 out of the delivery sheath 200 allows the device 100 to self-expand at the LAA 1a. Thereafter, the device 100 is detached from the delivery shaft 210. The device 100 is detached from the delivery shaft 210 by unscrewing the distal end of the delivery shaft 210 from within the first hub 160 of the device 100. Once the delivery shaft 210 is detached from the device 100, the delivery catheter 200 and delivery shaft 210 are manually withdrawn from the patient’s vasculature.
[063] The device 100 remains at the LAA 1a, where it facilitates reendothelialization as shown in Fig. 3. Reendothelialization helps the device 100 to integrate with the surrounding tissues and to seal off the LAA 1a completely.
[064] 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. , C , C , Claims:WE CLAIM:
1. A device (100) comprising:
a. a proximal end (100a) and a distal end (100b);
b. a frame (120) made of a plurality of struts (130) arranged circumferentially, each of the struts (130) of the plurality of struts (130) extends from the proximal end (100a) to the distal end (100b);
c. at least one linker (140) coupled to at least one pair of adjacently disposed struts (130); and
d. a membrane cover (190) disposed at least partially over at least one of an outer surface or an inner surface of the frame (120).
2. The device (100) as claimed in claim 1, wherein at least a portion of the struts (130) are coupled to a first hub (160) disposed at the proximal end (100a).
3. The device (100) as claimed in claim 1, wherein at least a portion of the struts (130) are coupled to a second hub (170) disposed at the distal end (100b).
4. The device (100) as claimed in claim 1, wherein the linkers (140) are disposed circumferentially around the frame (120) in at least one row.
5. The device (100) as claimed in claim 1, wherein the linkers (140) are disposed circumferentially around the frame (120) in a first row (140a) and a second row (140b), the second row (140b) being disposed relatively towards the distal end (100b) compared to the first row (140a).
6. The device (100) as claimed in claim 1, wherein the linkers (140) are provided alternatively between a first row (140a) and a second row (140b).
7. The device (100) as claimed in claim 1, wherein the struts (130) define a bend angle ranging from 15° to 60° with a respective plane defined by the proximal end (100a) and the distal end (100b).
8. The device (100) as claimed in claim 1, wherein at least one of the struts (130) and the linkers (140) are provided with at least one anchor elements (150).
9. The device (100) as claimed in claim 1, wherein the membrane cover (190) extends from the proximal end (100a) to at least one of a first row (140a) and a second row (140b) of the linkers (140).
10. The device (100) as claimed in claim 1, wherein a first hub (160) disposed at the proximal end (100a) is provided with a hole (180).
11. The device (100) as claimed in claim 1, wherein the proximal end (100a) and the distal end (100b) are close ended.
12. The device (100) as claimed in claim 1, wherein the frame (120) has a predefined shape including one of cylindrical, conical, crown, and spherical.
13. The device (100) as claimed in claim 1, wherein the struts (130) of the frame (120) are arranged in a predefined pattern including one of spiral, twisted, curve, Fibonacci curve, swirl, hyperbolic, and parabolic.
14. The device (100) as claimed in claim 1, wherein the linkers (140) are V-shaped, or Y-shaped.
15. The device (100) as claimed in claim 1, wherein at least a portion of the struts (130) are coupled to a second hub (170) disposed at a pre-defined distance away from the distal end (100b), the distal end (100b) defining a concave indentation extending towards the inside of the frame (120).