Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

1. TITLE OF THE INVENTION:
CLOSURE DEVICE
2. APPLICANT:
Meril Corporation (I) Private Limited, an Indian company of the address Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-396191 Gujarat, India.

The following specification particularly describes the invention and the manner in which it is to be performed:

 
FIELD OF INVENTION
[001] The present disclosure relates to a medical device. More particularly, the present disclosure relates to a percutaneous closure device for sealing a vascular tissue.
BACKGROUND OF THE INVENTION
[002] The heart is the principal organ of the blood circulatory system. The heart includes four compartments (or chambers) that contract in a rhythmic way to circulate (or pump) blood throughout the body. The left atrial chamber includes an extension in the form of a small pocket-like structure which is also known as the left atrial appendage (LAA). Ideally, in a healthy individual, the LAA is not part of the blood circulatory system.
[003] Irregular pumping of the heart due to chronic atrial fibrillation leads to an insufficient amount of blood being pumped from the left atrial chamber. Thus, the LAA retains the left-over blood that is not being pumped out of the left atrial chamber. This left-over blood within the LAA significantly increases the size of the clot within the LAA. The clots (thrombus) can form due to various factors, predominantly due to high cholesterol deposits. The clot when stagnant inside the LAA, does not result in any obstruction of pathway of capillary vessels. However, when the clot starts to break into smaller particles, it leads to prolapse of the clot into the blood circulatory system impeding the flow of blood to any part of the vasculature (like brain). This can result in stroke (like ischemic stroke), irregular heartbeat, blood vessel blockage or other conditions like cardiac embolism.
[004] To reduce the risk of a heart stroke, the LAA is removed through an open-heart surgery such as a coronary bypass surgery or a valve surgery. However, the risk of open-heart surgery being fatal to an individual, is always high and is preferred as a last resort of treatment.
[005] In recent times, an alternative to open-heart surgery includes the implantation of a Left Atrial Appendage Closure (LAAC) device. These typically cater to patients who are not suitable for open-heart surgeries. A LAAC device implantation is a minimally invasive procedure that is used to reduce the risk of a stroke that results from atrial fibrillation (also known as Afib or AF).
[006] The LAA is in continuous movement due to rhythmic contraction and dilation of the pumping/palpitating heart. Further, the flow of blood makes the LAA slippery. Under such circumstances, it is difficult to deploy a conventional LAAC device. More often than not, the LAAC device is incorrectly implanted and/or migrates post-deployment.
[007] In addition, a conventional LAAC device also suffers from post-implantation peri-device leakage. In other words, after the conventional LAAC device has been implanted, blood flow leakage has been observed from around the periphery of the LAAC device. This makes the LAAC device ineffective and the risk of stroke is still maintained post-implantation.
[008] Furthermore, conventional LAAC devices are made of double-disc (layer) structure. The double-disc structure includes relatively more metal mass per-unit volume of the LAAC device which delays endothelization. Due to the double-disc structure, it is difficult to load and deploy the device.
[009] Thus, there is a need for an improved closure device that overcomes the aforementioned challenges associated with conventional devices.
SUMMARY OF THE INVENTION
[0010] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
[0011] The present disclosure relates to a device including a proximal end, a distal end, a frame and a membrane. The frame is made of a plurality of members defining a single disc structure. The diameter of the frame increases from the proximal end to the distal end. Each member of the plurality of members includes a first portion disposed towards the proximal end defining a tubular profile, and a second portion disposed distal to the first portion and towards the distal end. The first portions of the plurality of members are at least partially coupled to each other. The membrane is disposed at least partially over at least one of an outer surface or an inner surface of the frame. The frame is made of a nitinol tube.
BRIEF DESCRIPTION OF DRAWINGS
[0012] The summary above and the detailed description of descriptive embodiments, is better understood when read in conjunction with the apportioned drawings. For illustration of the present disclosure, exemplary embodiments of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those skilled in the art will understand that the drawings are not to scale.
[0013] Figs. 1 and 1a depict a device 100 being implanted in a LAA 10a according to an embodiment of the present disclosure.
[0014] Fig. 2 depicts the device 100, according to an embodiment of the present disclosure.
[0015] Fig. 2a depicts a frame 110 of the device 100 according to an embodiment of the present disclosure.
[0016] Fig. 2b depicts a member 111 of the frame 110 according to an embodiment of the present disclosure.
[0017] Fig. 3 depicts an adapter of device 100 according to an embodiment of the present disclosure.
[0018] Fig. 4 depicts a side view of the membrane 130 according to an embodiment of the present disclosure.
[0019] Fig. 5 depicts a method 500 for deployment of the device 100 according to an embodiment of the present disclosure.
[0020] Figs. 6 and 6a depict the device 100 in a radially collapsed state coupled the delivery sheath 200 according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF DRAWINGS
[0021] Prior to describing the disclosure 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 may 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 practised 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] The present disclosure relates to a closure device (or device). The device may be used as a plug-like structure to occlude a vascular orifice. In an exemplary embodiment, the device is implanted at an entrance (or ostium) of the left atrial appendage (LAA) of the heart. Although the present disclosure is described with the example of LAA, the device of the present disclosure can be implanted across any vascular orifice and the same is within the scope of the teachings of the present disclosure.
[0026] The device of the present disclosure is flexible and conforms to various anatomies of vascular orifices. The device of the present invention prevents migration of the blood clots in patients suffering from Atrial fibrillation (AFib or AF) from the Left Atrial Appendage (LAA) to the rest of the circulatory system and thus leads to the prevention of transient ischemic attack, a stroke or a blood vessel blockage called an embolism.
[0027] The device of the present disclosure is provided with a self-expandable frame that is at least partially covered with a membrane. The membrane of the device promotes uniform and fast endothelization after deployment at the target site. Aforesaid endothelization plays a vital role in supply of oxygen and other nutrients to the tissues in the proximity of the device (such as parts of the LAA) which are essential for healthy rhythmic movement of the whole heart. The membrane is impermeable to the flow of blood or bodily fluids but plays a vital role in passing sufficient oxygen and nutrients to the tissues in the proximity of the device.
[0028] At least a portion of the frame is made flexible that flexibly conforms to the ostium of the LAA and prevents any potential risk of peri-device leak (PDL) post-implantation. The frame of the device promotes atraumatic deployment within the LAA. The device is provided with a plurality of barbs that help the device to engage with the surrounding tissue of the LAA thereby, preventing device migration and providing long-term stability to the device after deployment.
[0029] The device of the present disclosure has a simple construction including a single disc structure for easy and minimally invasive deployment, reducing the procedural complexity for medical professionals. The minimally invasive deployment of the device reduces the need for long hospital stays and promotes quicker recovery due to faster endothelization.
[0030] Now referring to the figures, Fig. 1 depicts a heart 10 with a diseased left atrial appendage (LAA) 10a. The heart 10 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 10a to seal the entrance of the LAA 10a. The entrance of the LAA 10a may be defined as an orifice through which there is a potential risk of a thrombus migration from the LAA 10a 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).
[0031] 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. The device 100 may be in a partially expanded state while deploying the device 100. While the device 100 is in the partially expanded state, at least a portion of the device 100 has a greater diameter than the diameter of the device 100 in the radially collapsed state.
[0032] The device 100 is radially collapsed and percutaneously advanced towards the LAA 10a via, for example, a delivery sheath 200. The delivery sheath 200 helps to constrain the device 100 in its radially collapsed state. The delivery sheath 200 encloses a delivery wire 210 operationally coupled to the proximal end 100a of the device 100. At the LAA 10a, the device 100 is radially expanded by either retracting the delivery sheath 200 from over the device 100 or by pushing the device 100 (and at least partially the delivery wire 210) out of the delivery sheath 200. The delivery wire 210 is then decoupled from the device 100 and withdrawn along with the delivery sheath 200.
[0033] Post-implantation, the proximal end 100a of the device 100 faces away from the LAA 10a and the distal end 100b of the device 100 faces towards the LAA 10a. The said disposition of the device 100 with respect to the LAA 10a helps to prevent migration of the blood clots from the LAA 10a to the rest of the circulatory system and thus leads to the prevention of transient ischemic attack, a stroke or an embolism.
[0034] Although the device 100 is described with the exemplary delivery sheath 200 for implantation, other functionally equivalent delivery devices to implant the device 100 are within the scope of the teachings of the present disclosure.
[0035] Fig. 2 depicts the device 100. The device 100 may have a pre-defined shape including, but not limited to, hemisphere, spherical, oval, parabolic, conical, flower-like, ellipse, diamond, hyperbolic, petal-like, etc. In an exemplary embodiment, as shown in Fig. 2, the device 100 is shaped flower-like.
[0036] The device 100 includes a frame 110 and at least one membrane 130 disposed at least partially over the frame 110. In an exemplary embodiment, as shown in Fig. 2, the proximal end 100a of the device 100 is close-ended and the distal end 100b of the device 100 is open-ended. In other words, close-ended refers to an end that does not include an opening while open-ended refers to an end that includes an opening via which at least partially, inner portions including the proximal end 100a of the device 100 are accessible.
[0037] Fig. 2a depicts the frame 110 of the device 100 having a single disc structure. The frame 110 may be dimensioned basis the anatomy of the LAA 10a. The frame 110 may be made of one or more shape-memory materials including, but not limited to, nitinol (nickel-titanium alloy), cobalt-chromium (Co-Cr), titanium, stainless steel, etc. In an exemplary embodiment, the frame 110 is laser-cut from a nitinol tube. The nitinol tube provides a durable and integral structure to the frame 110 having enhanced strength. The shape-memory material of the frame 110 enables the frame 110 (and the device 100) to self-expand from the radially collapsed state to the partially expanded state and then the radially expanded state at the time of implantation.
[0038] Alternatively, the frame 110 may be made of polymeric materials including, but not limited to, polydioxanone (PDO), poly(lactic-co-glycolic) acid (PLGA), etc. and the same is within the scope of the teachings of the present disclosure. In such case, at the time of deployment, the frame 110 is expanded using an external mechanism.
[0039] The diameter of the frame 110 increases from the proximal end 100a to the distal end 100b. In other words, the frame 110 tapers from the distal end 100b to the proximal end 100a. The frame 110, at the proximal end 100a has a tubular profile. The frame 110, at the distal end 100b has a substantially flat and circular profile. The maximum diameter of the frame 110 ranges from 16 mm to 38 mm. The minimum diameter of the frame 110 ranges from 13 mm to 36 mm. In an exemplary embodiment, the maximum diameter and the minimum diameter of the frame 110 is 28 mm and 25 mm, respectively.
[0040] The frame 110 may include a plurality of members 111 defining the single disc structure of the frame 110. The number of members 111 depends upon the size of the device 100. The members 111 can be arranged in a predefined arrangement such as circumferentially, diagonally, peripherally, equidistantly, non-equidistantly, symmetrically, asymmetrically, etc. relative to each other. The single disc structure of the frame 110 has less metal mass per unit volume of the frame 110 (and the device 100) which provides faster endothelization. The single-disc structure of the frame 110 helps in easy loading and deployment of the device 100.
[0041] In an exemplary embodiment, as shown in Fig. 2a, the members 111 of the frame 110 are arranged circumferentially and equidistantly around the device 100. Alternatively, not shown, the plurality of members 111 are irregularly arranged around the device 100. In an exemplary embodiment, the frame 110 includes six members 111. The members 111 may either form an integral structure or may be detachably coupled to each other to form the frame 110. In an exemplary embodiment, the frame 110 is an integral structure.
[0042] The members 111 may be coupled either directly to each other at the proximal end 100a of the device 100 or via an adapter 113. In an exemplary embodiment, as shown in Fig. 2a, the members 111 are coupled to each other at the proximal end 100a of the device 100 via the adapter 113. The members 111 resemble and behave as flexible radially flaring outward petal-like projections that abut the surrounding tissue of the LAA 10a after the device 100 radially expands within the LAA 10a. The members 111 thus completely conform to the annulus defined by the surrounding tissue of the LAA 10a and at least partially prevent peri-device leakage post-implantation. The members 111 at least partially prevent the device 100 from migrating away from the LAA 10a after the device 100 is implanted.
[0043] Fig. 2b depicts one of the plurality of members 111 of the device 100. Each member 111 includes one or more portions extending between the proximal end 100a and the distal end 100b of the device 100. In an exemplary embodiment, as shown in Fig. 2b, the member 111 is provided with a first portion 111a, and a second portion 111b. The first portion 111a is disposed at the proximal end 100a of the device 100 and the second portion 111b is disposed distal to the first portion 111a and towards the distal end 100b. The first portions 111a of the plurality of members 111 are at least partially coupled to each other. In an exemplary embodiment, not shown, the proximal end 100a of the first portion 111a of all the members 111 are coupled to each other. In another exemplary embodiment, as shown in Fig. 2a, the proximal end 100a of the first portion 111a of all the members 111 are coupled to each other via the adapter 113. The first portion 111a is coupled to the adapter 113 via one of laser welding, welding, soldering, brazing, etc. In an exemplary embodiment, the first portion 111a is coupled to the adapter 113 via laser welding.
[0044] The length of the first portion 111a ranges from 2 mm to 6 mm. In an exemplary embodiment, the length of the first portion 111a is 3 mm. The first portion 111a defines a maximum width ranging from 150 μm to 300 μm. In an exemplary embodiment, the maximum width of the first portion 111a is 220 μm. The first portion 111a includes at least two arms ‘A’ in the form of an inverted V-like structure. The arms ‘A’ of the first portion 111a may have a pre-defined cross-sectional shape including but not limited to circular, oval, rectangular, flat, square, etc. In an exemplary embodiment, the arms ‘A’ of the first portion 111a include rectangular and flat cross-sectional shape. The arms ‘A’ having rectangular and flat cross-sectional shape provides equal distribution of good radial strength leading to uniform expansion of the device 100 and better vessel conformity without any risk of damage. The width of the first portion 111a tapers from the proximal end 100a towards the distal end 100b. In an exemplary embodiment, as shown in Fig. 2a, the first portion 111a includes two arms ‘A’ in the form of the inverted V-like structure and defining a pre-defined angle therebetween. The pre-defined angle ranges from 10° to 20°. In an exemplary embodiment, the pre-defined angle is 14.6°. Free end of the arms ‘A’, at the proximal end 100a, extend away from the adapter 113 and are coupled thereto. In an embodiment, the arms ‘A’ of the first portion 111a are substantially curved. In another embodiment, the arms ‘A’ of the first portion 111a are at least partially wavy. In yet another embodiment, the arms ‘A’ of the first portion 111a are at least partially substantially straight.
[0045] In an exemplary embodiment, the arms ‘A’ of the member 111 are coupled to each other at the proximal end 100a and do not intersect with each other towards the distal end 100b. In another exemplary embodiment, as shown in Figs. 2a and 2b, the arms ‘A’ of the member 111 are separate from each other at the proximal end 100a and intersect with each other towards the distal end 100b. In yet another embodiment, the arms ‘A’ of the member 111 does not intersect with each other at both the proximal end 100a and towards the distal end 100b.
[0046] The second portion 111b of the member 111 at least partially includes at least two arms ‘B’ in the form of an upright V-shaped structure and defining a pre-defined angle therebetween. The arms ‘B’ of the second portion 111b may have a pre-defined cross-sectional shape including but not limited to circular, oval, rectangular, flat, square, etc. In an exemplary embodiment, the arms ‘B’ of the second portion 111b include rectangular and flat cross-sectional shape. The arms ‘B’ having rectangular and flat cross-sectional shape provides equal distribution of good radial strength leading to uniform expansion of the device 100 and better vessel conformity without any risk of damage. The arms ‘B’ of the member 111 extends distally away from the arms ‘A’ of the corresponding member 111 and coupled thereto. The pre-defined angle ranges from 45° to 75°. In an exemplary embodiment, the pre-defined angle is 54°. The length of the arms ‘B’ (and the second portion 111b) may range from 10 mm to 18 mm. In an exemplary embodiment, the length of the arms ‘B’ is 14 mm.
[0047] The distal end 100b of the arms ‘B’ are coupled to each other. The arms ‘B’ may be equidistantly or non-equidistantly disposed along the length of the arms ‘B’. In an exemplary embodiment, as shown in Figs. 2a and 2b, the arms ‘B’ of the member 111 are coupled to each other by one strut 111b1 disposed towards the distal end 100b. The strut 111b1 may have a pre-defined cross-sectional shape including but not limited to circular, oval, rectangular, flat, square, etc. In an exemplary embodiment, the strut 111b1 include rectangular and flat cross-sectional shape. The strut 111b1 having rectangular and flat cross-sectional shape provides equal distribution of good radial strength leading to uniform expansion of the device 100 and better vessel conformity without any risk of damage. The strut 111b1 may have a pre-defined shape including, but not limited to, U-shaped, C-shaped, V-shaped, etc. The strut 111b1 may either be stepped, regular, irregular, wavy, spiral, or a combination thereof. In an exemplary embodiment, as shown in Fig. 2b, the strut 111b1 is regular U-shaped. The strut 111b1 may have a pre-defined length ranging from 3 mm to 8 mm. In an exemplary embodiment, the length of the strut 111b1 is 5 mm. The strut 111b1 enables atraumatic and easy insertion of the device 100 within the LAA 10a.
[0048] The second portion 111b may have a maximum width ranging from 150 μm to 300 μm. In an exemplary embodiment, the maximum width of the second portion 111b is 220 μm. The width of the second portion 111b tapers from the distal end 100b towards the proximal end 100a. The second portion 111b at least partially helps the device 100 to prevent peri-device leak.
[0049] Although the members 111 of the frame 110 are described with the examples of the first portion 111a and the second portion 111b, a member may be made with only the second portion 111b or a member may be made with a second portion 111b and multiple first portions 111a. The same is within the scope of the teachings of the present disclosure.
[0050] At least one of the struts 111b1 and the arms ‘B’ of the second portion 111b is optionally provided with one or more barbs 111c. At least a portion of the barb 111c is coupled to an outer surface of the second portion 111b via at least one of welding, bonding, laser welding, soldering, etc. Additionally or alternatively, the barb 111c is laser cut along with the frame 110 and portions thereof. The barb 111c may be disposed either close to the first portion 111a, the distal end 100b, a center of the second portion 111b or a combination thereof. Alternately, the barbs 111c may be scattered and disposed at different spots on the second portion 111b.
[0051] Alternatively, at least one of the barbs 111c may be replaced with stepped struts, wavy struts, inverted-C struts or a combination thereof and the same is within the scope of the teachings of the present disclosure. In an exemplary embodiment, as shown in Fig. 2b, the second portion 111b of the member 111 includes two C-shaped barbs 111c. The length of the barbs 111c may range from 1 mm to 5 mm. In an exemplary embodiment, the length of the barb 111c is 3 mm. The barbs 111c abut the surrounding tissue of the LAA 10a after the device 100 is implanted thereby preventing the device 100 from migrating away from the LAA 10a.
[0052] The barbs 111c are made of one or more materials including, but not limited to, nitinol, Co-Cr, titanium, stainless steel, drawn filled tubes (DFT), etc. In an exemplary embodiment, the barbs 111c are made of nitinol. At least a portion of the barb 111c is coupled to the second portion 111b via at least one of welding, bonding, laser welding, soldering, etc. Additionally or alternatively, the barb 111c is laser cut along with the frame 110 and portions thereof. The barb 111c may be coupled either close to the first portion 111a, a center of the second portion 111b, at the distal end 100b or a combination thereof. In an exemplary embodiment, the barbs 111c are coupled to the distal end 100b of the arms ‘B’ via laser welding. The barbs 111c are configured to pierce the surrounding tissue of the LAA 10a to anchor the device 100 at the LAA 10a. Along with the members 111, the barbs 111c are also circumferentially arranged at least partially around the device 100. The barbs 111c help the device 100 to engage with the surrounding tissue of the LAA 10a thereby, preventing migration and providing long-term stability to the device 100 after deployment.
[0053] The barbs 111c may have a pre-defined shape including, but not limited to, C-shape, J-shape, U-shape, V-shape, etc. In an exemplary embodiment, as shown in Fig. 2b, the barbs 111c are C-shaped. A free end of the barbs 111c may point towards the proximal end 100a of the device 100 such that even if the device 100 is pushed out of the LAA 10a, anchorage provided by the barbs 111c improves.
[0054] The members 111 of the frame 110 are described as being constituted of discrete first portion 111a, the second portion 111b, and the barbs 111c. However, they may be integrally formed. Alternatively, they may be fixedly coupled to each other and the same are within the scope of the teachings of the present disclosure.
[0055] The frame 110 of the device 100 is optionally provided with one or more radiopaque markers (not shown). The radiopaque markers may be made of one or more materials including, but not limited to, stainless steel, platinum iridium, platinum tungsten, tantalum, nitinol, titanium, etc. In an exemplary embodiment, the radiopaque markers are made of platinum iridium. The radiopaque markers help to visualize the device 100 using fluoroscopy imaging techniques after and/or during the deployment of the device 100.
[0056] The radiopaque markers are provided with at least one of the adapter 113 and the barbs 111c of the members 111. The radiopaque marker provided with the adapter 113, helps to visualize the position of the proximal end 100a of the device 100. And, the radiopaque markers provided with the barbs 111c of the frame 110 help to visualize the radial expansion of the device 100 from the radially collapsed state to the radially expandable state. Optionally, the arms ‘A’ and the arms ‘B’ may be provided with the radiopaque markers.
[0057] The proximal end 100a of the frame 110 is depicted in Fig. 2a depicting the member 111 of the frame 110 coupled to the adapter 113. In an exemplary embodiment, as shown in Figs. 2a and 3, the adapter 113 is a cup-shaped body. Other shapes of the adapter 113 is within the scope of the teachings of the present disclosure.
[0058] The adapter 113 defines a cavity 113a disposed at the proximal end 100a of the device 100. The cavity 113a is configured to be operationally coupled to the delivery wire 210 of the delivery sheath 200.
[0059] In an exemplary embodiment, as shown in Fig. 3, the cavity 113a and a distal end of the delivery wire 210 are provided with complementing plurality of threads. The plurality of threads facilitates the device 100 to be screwed at the distal end of the delivery wire 210. Accordingly, the device 100 may be unscrewed from the distal end of the delivery wire 210 post-implantation.
[0060] Although the coupling between the delivery wire 210 and the adapter 113 of the device 100 is described with the example of the plurality of threads, other functionally equivalent mechanisms/structures are within the scope of the teachings of the present disclosure. In an alternate embodiment, instead of the adapter 113, the proximal end 100a of the members 111 are coupled to each other to form a flange (not shown) provided with a plurality of threads. The flange may be functionally similar to the adapter 113.
[0061] Fig. 4 depicts at least one membrane 130 disposed over at least a portion of an outer surface of the members 111. Alternatively, the membrane 130 may be disposed over a portion of an inner surface of the frame 110. In an exemplary embodiment, the membrane 130 is disposed over a proximal portion of the outer surface of the members 111.
[0062] In an exemplary embodiment, as shown in Fig. 2, the membrane 130 extends from the proximal end 100a of the frame 110 to the barbs 111c of the members 111. The membrane 130 covers the first portion 111a of the members 111 and at least partially covers the second portion 111b of the members 111. In the depicted embodiment, the barbs 111c are partially covered by the membrane 130. In another embodiment, not shown, the first portion 111a, and the second portion 111b are completely covered with the membrane 130. In yet another embodiment, not shown, the first portion 111a, the second portion 111b and the barbs 111c are completely covered with the membrane 130.
[0063] The proximal end 100a of the membrane 130 is optionally provided with an opening 131 corresponding to the cavity 113a of the adapter 113. The opening 131 allows the delivery wire 210 to be operationally coupled to the adapter 113 of the frame 110. An outer diameter of the adapter 113 is greater than the diameter of the opening 131 of the membrane 130. The adapter 113, thus prevents any leakage of blood (or clots thereof) through the opening 131 of the membrane 130.
[0064] The membrane 130 is made of one or more woven or non-woven fabrics, including but not limited to, Polyethylene terephthalate (PET) fabric, polyester fabric, silicone, urethane, other biocompatible polymer(s), Dacron, bioabsorbable systems, copolymers, or combinations thereof. In an exemplary embodiment, the membrane 130 is made of PET fabric. The membrane 130 of the device promotes uniform and fast endothelization post-implantation. Aforesaid endothelization plays vital role in supply of oxygen and other nutrients to the tissues in the proximity of the device (such as, parts of the LAA) which are essential for healthy rhythmic movement of the whole heart. The membrane 130 is impermeable to flow of blood, clots or bodily fluids but plays a vital role in passing sufficient oxygen and nutrients to the tissues in the proximity of the device 100.
[0065] Fig. 5 depicts an exemplary method 500 to deploy the device 100 using the delivery sheath 200. The method 500 is used to occlude a vascular orifice, for example, the LAA 10a of the heart 10.
[0066] The method commences at step 501 by radially collapsing the device 100 and loading the device 100 in its radially collapsed state within a lumen of the delivery sheath 200.The delivery sheath 200 helps to constrain the device 100 in its radially collapsed state and facilitates atraumatic deployment of the device 100. The length of the device 100 in its radially crimped state (also known as the crimping length) ranges from 30mm to 60mm. In an exemplary embodiment, the crimping length is 35 mm. The crimping length of the device 100 is less as the device 100 is laser-cut from a nitinol tube and has a integral structure.
[0067] At step 503, the proximal end 100a of the device 100 is coupled to the distal end of the delivery wire 210 disposed at least partially within the lumen of the delivery sheath 200 (as shown in Fig. 6a). In an exemplary embodiment, as shown in Fig. 3, the cavity 113a of the adapter 113 and the distal end of the delivery wire 210 are provided with complementing plurality of threads. The plurality of threads facilitates the device 100 to be screwed at the distal end of the delivery wire 210 thereby removably coupling the device 100 to the deliver wire.
[0068] Alternatively, the device 100 may be coupled to the delivery wire 210 before loading the device 100 within the lumen of the delivery sheath 200. In other words, step 303 may be executed before step 301 and the same is within the scope of the teachings of the present disclosure.
[0069] At the step 505, the device 100 in its radially collapsed state and disposed within the lumen of the delivery sheath 200 is percutaneously introduced within the body. The delivery sheath 200 is advanced through the vasculature.
[0070] At step 507, the device 100 in its radially collapsed state and disposed within the lumen of the delivery sheath 200 is positioned in close proximity to the implantation site, i.e., the left atrial appendage (LAA) 10a (as shown in Fig. 6).
[0071] At the step 509, the device 100 is allowed to self-expand from its radially collapsed state to its radially expanded state. The device 100 is allowed to self-expand by either at least partially pushing the delivery wire 210 out of the delivery sheath 200, at least partially pulling the delivery sheath 200 over the delivery wire 210 or a combination thereof. In other words, the constrain provided by the delivery sheath 200 is removed from around the device 100, thereby allowing the device 100 to self-expand to the radially expanded state from the radially collapsed state.
[0072] While the device 100 self-expands, the barbs 111c engages with the surrounding tissue of the LAA 10a thereby preventing device migration and providing long-term stability to the device 100. The frame 110 conforms to the anatomy of the LAA 10a thereby sealing/occluding the LAA 10a. The device, post-implantation, prevents any potential risk of peri-device leak (PDL).
[0073] At step 511, the distal end of the delivery wire 210 is decoupled form the proximal end 100a of the device 100. In an exemplary embodiment, the device 100 is unscrewed from the distal end of the delivery wire 210 thereby leaving the device 100 implanted at the LAA 10a.
[0074] At step 513, the delivery sheath 200 along with the delivery wire 210 is withdrawn from within the vasculature.
[0075] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM:
1. A device (100) comprising:
a. a proximal end (100a) and a distal end (100b);
b. a frame (110) made of a plurality of members (111) defining a single disc structure, the diameter of the frame (110) increases from the proximal end (100a) to the distal end (100b), each member (111) of the plurality of members (111) includes:
i. a first portion (111a) disposed towards the proximal end (100a) defining a tubular profile, the first portions (111a) of the plurality of members (111) are at least partially coupled to each other, and
ii. a second portion (111b) disposed distal to the first portion (111a) and towards the distal end (100b); and
c. a membrane (130) disposed at least partially over at least one of an outer surface or an inner surface of the frame (110);
wherein, the frame (110) is made of a nitinol tube.
2. The device (100) as claimed in claim 1, wherein the members (111) are arranged in a predefined arrangement including at least one of circumferentially, diagonally, peripherally, equidistantly, non-equidistantly, symmetrically, and asymmetrically.
3. The device (100) as claimed in claim 1, wherein the members (111) are coupled to each other at the proximal end (100a) via an adapter (113).
4. The device (100) as claimed in claim 1, wherein the first portion (111a) includes at least two arms ‘A’
a. in the form of an inverted V-like structure defining a pre-defined angle therebetween, the pre-defined angle ranging from 10° to 20°, and
b. having rectangular and flat cross-sectional shape.
5. The device (100) as claimed in claim 1, wherein the width of the first portion (111a) tapers from the proximal end (100a) towards the distal end (100b), the maximum width ranging from 150 μm to 300 μm.
6. The device (100) as claimed in claim 1, wherein the length of the first portion (111a) ranges from 2 mm to 6 mm.
7. The device (100) as claimed in claim 1, wherein the second portion (111b) includes at least two arms ‘B’
a. in the form of an upright V-shaped structure and defining a pre-defined angle therebetween, the pre-defined angle ranges from 45° to 75°, and
b. having rectangular and flat cross-sectional shape.
8. The device (100) as claimed in claim 1, wherein the width of the second portion (111b) tapers from the distal end 100b towards the proximal end 100a, the maximum width ranging from 150 μm to 300 μm.
9. The device (100) as claimed in claim 1, wherein the length of the second portion (111b) ranges from 10 mm to 18 mm.
10. The device (100) as claimed in claim 1, wherein the second portion (111b) includes at least two arms ‘B’ coupled to each other by at least one strut (111b1) disposed towards the distal end (100b).
11. The device (100) as claimed in claim 1, wherein the second portion (111b) is provided with one or more barbs (111c) having a pre-defined shape including, at least one of C-shape, J-shape, U-shape, and V-shape.
12. The device (100) as claimed in claim 1, wherein the membrane (130) is made of at least one of Polyethylene terephthalate (PET) fabric, polyester fabric, silicone, urethane, other biocompatible polymer(s), Dacron, bioabsorbable systems, and copolymers.
13. The device (100) as claimed in claim 1, wherein the device (100) has a pre-defined shape including at least one of hemisphere, spherical, oval, parabolic, conical, flower-like, ellipse, diamond, hyperbolic, and petal-like.
14. The device (100) as claimed in claim 1, wherein the frame (110) is made of one or more shape-memory materials including nitinol (nickel-titanium alloy), cobalt-chromium (Co-Cr), titanium, and stainless steel.
15. The device (100) as claimed in claim 1, wherein the members (111) of the frame (110) resemble a flexible radially flaring outward petal-like projections.