Closed device

Abstract

This disclosure discloses a device comprising a frame having a predetermined length and extending between a proximal end and a distal end. The frame comprises a first portion, a second portion, a third portion, and a fourth portion. The first portion is disposed at the distal end and forms a predetermined angle "f" with the distal end. The second portion is disposed adjacent to the first portion and forms a predetermined angle "s" with the distal end. The third portion is disposed adjacent to the second portion and forms a predetermined angle "t" with the distal end. The fourth portion is disposed at the proximal end and forms a predetermined angle "o" with the distal end. A first jacket is coupled to the proximal end, and a second jacket is coupled to the distal end.

Description

Technical Field

[0001] The present invention relates to medical devices. More particularly, the present invention relates to percutaneous closure devices for sealing vascular tissue.

Background Art

[0002] The heart is a major organ of the blood circulation system. The heart has four compartments (or chambers), which rhythmically contract to circulate (or pump) blood throughout the body. The left atrial chamber includes an extension in the form of a small pocket-shaped structure also known as the left atrial appendage (LAA). In healthy individuals, it is desirable for the LAA not to be part of the blood circulation system.

[0003] High cholesterol deposits are known to be associated with blood clot (or thrombus) formation. This thrombus formation can occur anywhere within the blood circulation system, including inside the LAA of the left atrium. Thrombus in the LAA causes atrial fibrillation (a type of cardiac arrhythmia).

[0004] Due to the irregular pumping action of the heart caused by chronic atrial fibrillation, the amount of blood pumped from the left atrium is insufficient. As a result, the LAA retains the remaining blood that has not been pumped out from the left atrium. The blood remaining in this LAA significantly increases the size of the thrombus in the LAA. When the thrombus remains in the LAA, it does not cause any blockage of the capillary pathways. However, when the thrombus begins to break down into smaller particles, this leads to the escape of the thrombus into the blood circulation system, preventing blood flow to any part of the vascular system (such as the brain), resulting in a stroke (such as an ischemic stroke).

[0005] To reduce the risk of heart attack, the LAA is removed by open heart surgery during coronary artery bypass surgery or valve surgery. However, the risk of open heart surgery being fatal to that individual is always high, and it is recommended to be selected as a last resort for treatment.

[0006] In recent years, left atrial appendage closure (LAAC) devices have been introduced for patients who are not suitable for open-heart surgery. LAAC device implantation is a minimally invasive procedure used to reduce the risk of stroke caused by atrial fibrillation (also known as Afib or AF).

[0007] The LAA is constantly moving due to the rhythmic contraction and expansion of the beating heart. Furthermore, blood flow makes it difficult to capture the LAA, which makes it challenging to properly position conventional LAAC devices during the implantation procedure. In most cases, this leads to improper placement of the LAAC device during implantation and / or migration of the LAAC device after implantation. [Overview of the project] [Problems that the invention aims to solve]

[0008] Therefore, an improved closure device is needed that overcomes the aforementioned challenges associated with conventional devices. [Means for solving the problem]

[0009] While specific embodiments of the Disclosure are described below with reference to the accompanying drawings, it should be understood that the disclosed embodiments are merely examples of the Disclosure as it can be embodied in various forms. To avoid obscuring the Disclosure with unnecessary detail, well-known functions or structures are not described in detail. Therefore, the specific details relating to the structures and functions disclosed herein should be interpreted not as limiting, but merely as a basis for the claims and as a representative basis for instructing those skilled in the art to utilize the Disclosure in various structures with substantially any appropriate details.

[0010] The present invention relates to a device comprising a frame, a first jacket, and a second jacket. The frame has a predetermined length and extends between a proximal end and a distal end. The frame has a plurality of parts, including at least a first part, a second part, a third part, and a fourth part. The first part is located at the distal end and forms a predetermined angle "f" with the distal end in the range of 30° to 80°. The second part is located adjacent to the first part and forms a predetermined angle "s" with the distal end in the range of 120° to 140°. The third part is located adjacent to the second part and forms a predetermined angle "t" with the distal end in the range of 30° to 90°. The fourth part is located at the proximal end and forms a predetermined angle "o" with the distal end in the range of 110° to 135°. The first jacket is attached to the proximal end and is at least partially surrounded by at least one of the third and fourth portions. The second jacket is attached to the distal end and is at least partially surrounded by the first portion.

[0011] The above summary and the following detailed description of exemplary embodiments will be better understood when read together with the distributed drawings. For illustrative purposes, exemplary structures of the disclosure are shown in the drawings. However, the disclosure is not limited to the specific methods and means disclosed herein. Furthermore, those skilled in the art will understand that the drawings are not drawn to exact scale. [Brief explanation of the drawing]

[0012] [Figure 1] This is a diagram of device 100 according to an embodiment of the present invention. [Figure 2] This is a diagram of the frame 110 of device 100 according to an embodiment of the present invention. [Figure 3] This figure illustrates a method 300 for fabricating device 100 according to an embodiment of the present invention. [Modes for carrying out the invention]

[0013] Before describing the present invention in detail, we define certain words or phrases used throughout this patent document. The terms “include” and “comprise,” and their derivatives, mean to include without limitation. The term “or” means comprehensive and / or. The phrases “coupled with” and “associated therewith,” and their derivatives, may mean to include, contain in, interconnect with, encompass, be contained within, connect to or with, be coupled to or with, be communicable with, cooperate with, alternate, juxtapose, be close to, be associated with or with, have the characteristics of, etc. Although definitions of certain words and phrases are given throughout this patent document, those skilled in the art will understand that such definitions often, if not most, also apply to earlier and later uses of the defined words and phrases.

[0014] Throughout this specification, any reference to “one embodiment,” “a particular embodiment,” or similar phrases means that any specific feature, structure, or characteristic described in relation to that embodiment is included in at least one embodiment. Thus, throughout this specification, any use of the phrases “in one embodiment,” “in a particular embodiment,” and similar phrases means “one or more embodiments, but not all of them,” although they may all refer to the same embodiment, unless otherwise explicitly stated. The terms “including,” “comprising,” “having,” and their variations mean “including but not limited to,” unless otherwise explicitly stated. Unless otherwise explicitly stated, a list of items does not imply that any or all of those items are mutually exclusive and / or mutually exclusive. The terms “a,” “an,” and “the” also mean “one or more,” unless otherwise explicitly stated.

[0015] While the operations of exemplary embodiments of the disclosed methods may be described in a specific sequential order for presentation purposes, it should be understood that the disclosed embodiments may encompass orders of operations other than the specific sequential order disclosed. For example, operations described sequentially may, in some cases, be rearranged or performed simultaneously. Furthermore, descriptions and disclosures provided in association with a particular embodiment are not limited to that embodiment and may apply to any embodiment disclosed herein. Also, for the sake of brevity, the accompanying figures may not show various techniques by which the disclosed systems, methods, and apparatus can be used in combination with other systems, methods, and apparatus.

[0016] Furthermore, the features, advantages, and characteristics described in the examples may be combined in any preferred manner. Those skilled in the art will recognize that the examples can be implemented even without one or more of the specific features or advantages of a particular example. In some cases, additional features and advantages may be recognized in a particular example, but these may not be present in all examples. These features and advantages of the examples will be more readily apparent from the following description and the allocated claims, or will be understood by implementing the examples described below.

[0017] The present invention discloses a closure device (or device). The device can be used to close a vascular opening. In an exemplary embodiment, the device is implanted in the opening (or ostium) of the left atrial appendage (LAA) of the heart.

[0018] The device of the present invention includes a single-lobe structure. The single-lobe structure of the device contributes to easy loading and re-capture of the device. Furthermore, the single-lobe structure of the device helps to reduce the deployment time when implanting the device in a vascular opening.

[0019] Compared with conventional devices, the device of the present invention has less metallic material introduced into the body. The device of the present invention has sufficient flexibility to fit various types of vascular openings. The device can seal vascular openings with the diameter of the landing area ranging from 16 mm to 38 mm. The diameter of the landing area is an inherent characteristic of the vascular opening and is determined manually, for example, from the echocardiogram image of the vascular opening.

[0020] The device includes a frame made by braiding monofilaments (or multifilaments). The free ends of the frame at the proximal end and the distal end are fixed by the first jacket and the second jacket. The first and second jackets provide and maintain the structural integrity and strength of the frame and the device.

[0021] At the distal end, the monofilament is curved within the frame such that the monofilament extends axially at least partially towards the proximal end of the frame. As a result, the second jacket is disposed within the frame 110, thereby minimizing metal contact with the surrounding tissue of the vascular opening.

[0022] The device has a cup-shaped proximal end that contributes to recapturing, repositioning, and redeploying the device completely, enabling the user to deploy the device accurately into the vascular opening. Further, the cup shape of the proximal end prevents and / or minimizes the metal contact of the first jacket with the surrounding tissue of the vascular opening when deploying the device. The proximal end of the frame 110 also contributes to early endothelialization.

[0023] The first part of the frame helps the device to fit snugly within the vascular opening, minimizing the risk of device movement. The third part of the frame gives the device strength to resist the surrounding tissue at the implantation site, thereby preventing the device from moving away from the implantation site after device deployment. The fourth part of the frame provides a strong grip on the device at the vascular opening when deploying the device.

[0024] The device is provided with a plurality of returns, which assist in the engagement of the device with the surrounding tissue of the vascular opening, thereby preventing the movement of the device and providing long-term stability to the device after deployment. The J-shaped anchors of the returns prevent the returns from coming off (or being damaged) during the loading / deployment of the device.

[0025] The returns straighten within the concave shape of the second portion of the frame while loading the device through the sheath, thus assisting in the smooth loading of the device.

[0026] Referring to the figures, FIG. 1 depicts an exemplary embodiment of the device 100 of the present invention. The device 100 includes a frame 110 that extends between a proximal end 120 and a distal end 130. Further, the device 100 may comprise a plurality of returns 140 and / or at least one cover 150.

[0027] The frame 110 of the device 100 is depicted in FIG. 2. The frame 110 is radially compressible to a compressed state in order to guide the device 100 within the human body to the vascular opening. The frame 110 is radially expandable to an expanded state when deploying the device 100 at the vascular opening. The frame 110 may be fabricated by braiding a plurality of monofilaments or a plurality of multifilaments. The monofilaments and / or multifilaments of the frame 110 may be made of a self-expanding material such as nitinol, tungsten, etc., or other composite materials used for, e.g., drawn filled tubing (DFT) - wire, etc. In an exemplary embodiment, the drawn filled tubing - wire provides radiopacity, shape retention, and good strength through a single wire. In an exemplary embodiment, the frame 110 is fabricated by braiding nitinol monofilaments. The monofilaments may have a predetermined diameter in the range of 70 μm (microns) to 300 μm (microns). In an exemplary embodiment, the diameter of the monofilaments is 150 μm (microns).

[0028] Multiple monofilaments can be braided together at a predetermined braiding angle "b". The braiding angle "b" ranges from 110° to 140°, depending on the size of the device 100. The braiding angle "b" ensures the strength and integrity of the device 100. In an exemplary embodiment, the braiding angle "b" ranges from 125° to 127°.

[0029] Multiple monofilaments can be joined to each other via a first jacket 120a at the proximal end 120 and via a second jacket 130a at the distal end 130. In exemplary embodiments, the first jacket 120a and the second jacket 130a are welded to the monofilaments at the proximal end 120 and the distal end 130, respectively. The first jacket 120a and the second jacket 130a provide and maintain the structural integrity and strength of the frame 110 and the device 100. Other functionally equivalent means of joining the first jacket 120a and the second jacket 130a to the monofilaments are within the scope of the teachings of the present invention.

[0030] In an exemplary embodiment, the monofilament is braided from the proximal end 120 to the distal end 130. The monofilament is then curved within the frame 110 such that it extends axially at least partially toward the proximal end 120. The free end of the monofilament is then welded together at the distal end 130, allowing the second jacket 130a to be positioned within the frame 110. This helps to minimize metallic contact with the surrounding tissue of the vascular opening.

[0031] The first jacket 120a and the second jacket 130a may be made from materials including, but not limited to, stainless steel, platinum iridium, platinum tungsten, tantalum, etc. The materials of the first jacket 120a and the second jacket 130a may have a thickness in the range of 150 μm to 180 μm. In an exemplary embodiment, the first jacket 120a and the second jacket 130a may be made from stainless steel with a thickness of 150 μm. The first jacket 120a and the second jacket 130a maintain the integrity of the frame 110 and the device 100. The first jacket 120a and the second jacket 130a allow the device 100 to be imaged / observed under fluorescence imaging techniques after and / or during implantation of the device 100.

[0032] The first jacket 120a, extending towards the proximal end 120, may be provided with a plurality of internal threads (not shown). These internal threads of the first jacket 120a can be removably coupled to a delivery wire of a delivery system. The delivery system is used to deploy the device 100 to a vascular opening (described later). Other functionally equivalent means for coupling the delivery wire to the first jacket 120a are within the scope of the teachings of this invention.

[0033] The cross-section of the frame 110 may have a predetermined shape, including but not limited to circular, crown-shaped, oval, etc. In an exemplary embodiment, the cross-section of the frame 110 is circular.

[0034] Similarly, the axial cross-section of the frame 110 may have a predetermined shape, including but not limited to hourglass, apple, ellipse, egg, circle, rhombus, etc. In an exemplary embodiment, as shown in Figure 2, the axial cross-section of the frame 110 is hourglass-shaped. The frame 110 may have a predetermined length in the range of 8 mm to 26 mm. In an exemplary embodiment, the length of the frame 110 is 16 mm.

[0035] The frame 110 may be flat, tapered, convex, or concave at its distal end 130. In an exemplary embodiment, as shown in Figure 2, the distal end 130 of the frame 110 is flat. The distal end 130 of the frame 110 provides strength to the frame 110, which will be held at the vascular opening, thereby covering and sealing the entire vascular opening in which the device 100 is deployed.

[0036] The frame 110 may include a plurality of portions disposed between the proximal end 120 and the distal end 130. In an exemplary embodiment, as shown in Figure 2, the frame 110 includes a first portion 110a, a second portion 110b, a third portion 110c, and a fourth portion 110d.

[0037] Although the frame 110 is described using multiple parts, the frame 110 is a single, integrated structure. Alternatively, the frame 110 may have separate parts that are fixedly or detachably connected to one another, and this is within the scope of the teachings of the present invention.

[0038] The first portion 110a may be located at the distal end 130 of the frame 110. The frame 110 may be flat, tapered, convex, or concave in the first portion 110a. In an exemplary embodiment, as shown in Figure 2, the first portion 110a of the frame 110 is convex. The frame 110 may have a maximum diameter in the first portion 110a ranging from 16 mm to 38 mm. In an exemplary embodiment, the maximum diameter of the frame 110 in the first portion 110a is 28 mm. The frame 110 may have a length in the first portion 110a ranging from 2 mm to 8 mm. In an exemplary embodiment, the length of the first portion 110a is 4 mm. The first portion 110a of the frame 110 helps the device 100 to fit snugly into the vascular opening, minimizing the risk of the device 100 moving.

[0039] The lower end of the first portion 110a of the frame 110 may define a predetermined angle "f" with respect to an axis "fx" parallel to the distal end 130 of the frame 110. The predetermined angle is in the range of 30° to 80°. In an exemplary embodiment, the predetermined angle "f" defined by the lower end of the first portion 110a of the frame 110 is 41°.

[0040] In an exemplary embodiment, as shown in Figure 2, the second jacket 130a is at least partially surrounded by the first portion 110a of the frame 110. This helps to minimize metallic contact with the surrounding tissue of the vascular opening.

[0041] The second portion 110b may be positioned adjacent to the first portion 110a. The frame 110 in the second portion 110b may be flat, tapered, convex, or concave. In an exemplary embodiment, as shown in Figure 2, the second portion 110b of the frame 110 is concave. The frame 110 in the second portion 110b may have a minimum diameter in the range of 13 mm to 33 mm. In an exemplary embodiment, the minimum diameter of the frame 110 in the second portion 110b is 24 mm. The frame 110 in the second portion 110b may have a length in the range of 3 mm to 8 mm. In an exemplary embodiment, the length of the second portion 110b is 5 mm.

[0042] The lower end of the second portion 110b of the frame 110 may define a predetermined angle "s" with respect to an axis "sx" parallel to the distal end 130 of the frame 110. The predetermined angle is in the range of 120° to 140°. In an exemplary embodiment, the predetermined angle "s" defined by the lower end of the second portion 110b of the frame 110 is 120°.

[0043] The third portion 110c may be positioned adjacent to the second portion 110b. The frame 110 may be flat, tapered, convex, or concave in the third portion 110c. In an exemplary embodiment, as shown in Figure 2, the third portion 110c of the frame 110 tapers outward from the distal end 130 to the proximal end 120. The frame 110 may have its maximum diameter at the proximal end 120 and its minimum diameter at the distal end 130 in the third portion 110c. The minimum diameter of the third portion 110c is in the range of 14 mm to 36 mm. The maximum diameter of the third portion 110c is in the range of 16 mm to 38 mm. In an exemplary embodiment, the minimum and maximum diameters of the third portion 110c are 26 and 28, respectively. The frame 110 may have a length in the range of 0.5 mm to 1.5 mm in the third portion 110c. In the exemplary embodiment, the length of the third portion 110c is 1 mm. The third portion 110c of the frame 110 provides the device 100 with strength to resist the surrounding tissue of the implantation site, thereby preventing the device 100 from moving away from the implantation site after deployment.

[0044] The lower end of the third portion 110c of frame 110 may define a predetermined angle "t" with respect to an axis "tx" parallel to the distal end 130 of frame 110. The predetermined angle is in the range of 30° to 90°. In an exemplary embodiment, the predetermined angle "t" defined by the lower end of the third portion 110b of frame 110 is 80°.

[0045] The fourth portion 110d may be positioned adjacent to the third portion 110c at the proximal end 120. The frame 110 may be flat, tapered, convex, or concave in the fourth portion 110d. In an exemplary embodiment, as shown in Figure 2, the fourth portion 110d of the frame 110 tapers inward from the distal end 130 towards the proximal end 120. The frame 110 may have its maximum diameter at the distal end 130 and its minimum diameter at the proximal end 120 in the fourth portion 110c. The minimum diameter of the fourth portion 110d is in the range of 8 mm to 22 mm. The maximum diameter of the fourth portion 110d is in the range of 16 mm to 38 mm. In an exemplary embodiment, the minimum and maximum diameters of the fourth portion 110d are 16 and 28, respectively. The frame 110 may have a length in the range of 2 mm to 10 mm in the fourth portion 110d. In an exemplary embodiment, the length of the fourth portion 110d is 6 mm at a 130° angle. The fourth portion 110d provides a strong grip on the device 100 at the vascular opening when the device 100 is deployed.

[0046] The lower end of the fourth portion 110d of frame 110 may define a predetermined angle "o" with respect to an axis "ox" parallel to the distal end 130 of frame 110. The predetermined angle is in the range of 110° to 135°. In an exemplary embodiment, the predetermined angle "o" defined by the lower end of the fourth portion 110d of frame 110 is 117°.

[0047] In an exemplary embodiment, as shown in Figure 2, the frame 110 appears coronal in the third portion 110c and the fourth portion 110d. The coronal shape of the frame 110 is always at least 20% to 30% larger than the vascular opening into which the device 100 will be deployed. Thus, the coronal shape of the frame 110 helps to securely fix the device 100 in the vascular opening, thereby preventing the device 100 from coming loose or moving out of the vascular opening.

[0048] In one embodiment, as shown in Figure 2, the fourth portion 110d curves at the proximal end 120 and extends at least partially toward the distal end 130, thereby forming a cup-shaped proximal end 120. The cup-shaped proximal end 120 has a tapered contour. The cup shape of the proximal end 120 prevents and / or minimizes metallic contact of the first jacket 120a with the surrounding tissue of the vascular opening when the device 100 is deployed (as described later).

[0049] Although the proximal end 120 of device 100 is described as having a cup shape, other functionally equivalent shapes of the proximal end 120 are within the scope of the teachings of the present invention.

[0050] The proximal end 120 of frame 110 may define a predetermined angle "p" with respect to an axis "px" parallel to the distal end 130 of frame 110. The predetermined angle is in the range of 70° to 100°. In an exemplary embodiment, the predetermined angle "p" defined by the proximal end 120 of frame 110 is 75°.

[0051] In an exemplary embodiment, the cup shape of the proximal end 120, as shown in Figure 2, causes the first jacket 120a to be laterally surrounded by at least one of the third portion 110c and the fourth portion 110d of the frame 110. This minimizes metal-to-metal contact with surrounding tissue at the vascular opening and promotes endothelialization of the device 100 after implantation. Furthermore, due to the first jacket 120a being surrounded by the frame 110 and the tapered structure of the fourth portion 110d of the frame 110, the force required to load / re-capture the device 100 by pulling the delivery wire (removably coupled to the first jacket 120a) (e.g., within a catheter of a delivery system) is significantly reduced. This allows the user to easily reposition and re-deploy the device 100 at the vascular opening, ensuring accurate deployment of the device 100.

[0052] The frame 110 may be flat, tapered, convex, or concave at its distal end 120. In an exemplary embodiment, as shown in Figure 2, the proximal end 120 of the frame 110 is cup-shaped (or scalloped). The cup-shaped proximal end 120 also contributes to fully re-grabbing, repositioning, and re-deploying the device 100, thereby enabling the user to accurately deploy the device 100 to the vascular opening. The proximal end 120 of the frame 110 contributes to early endothelialization.

[0053] As shown in Figure 1, the frame 110 is provided with a plurality of ribs 140. The ribs 140 can be attached to at least one of the parts of the frame 110 by at least one of suturing, welding, crimping, etc. The ribs 140 may be arranged circumferentially around the frame 110. The ribs 140 may be arranged equidistant from each other. In an exemplary embodiment, as shown in Figure 1, the ribs 140 are sutured symmetrically around the second part 110b and the third part 110c of the frame 110 so that the device 100 can engage uniformly with the surrounding tissue of the vascular opening.

[0054] In the exemplary embodiment, the return 140 straightens out within the concave shape of the second portion 110b of the frame 110 while the device 100 is loaded through the sheath. In other words, the second portion 110b contributes to the smooth loading of the device 100.

[0055] The return 140 may be made from materials including, but not limited to, nitinol, stainless steel, etc. In an exemplary embodiment, the return 140 is made of nitinol. The return 140 helps the device 100 engage with the surrounding tissue of the vascular opening, thereby preventing the device 100 from moving and providing long-term stability to the device 100 after deployment.

[0056] Device 100 includes 4 to 10 return 140s. In an exemplary embodiment, each return 140 includes two J-shaped anchors. The J-shaped anchors of the return 140 prevent the return 140 from coming loose (or being damaged) during loading / deployment of device 100.

[0057] In an exemplary embodiment, device 100 is provided with six return points. Therefore, device 100 includes twelve J-shaped anchors.

[0058] Other functionally equivalent shapes of the return 140 anchor are within the scope of the teachings of this invention.

[0059] In addition, or optionally, the return 140 may be provided with one or more radiopaque markers. In an exemplary embodiment, each of the return 140 is provided with a coil marker. The radiopaque markers may be made from materials including, but not limited to, platinum-iridium, platinum-tungsten, tantalum, stainless steel, etc. In an exemplary embodiment, the radiopaque markers are made from stainless steel. The X-ray radiopaque markers are useful for visualizing the device 100 using fluorescence imaging techniques after and / or during deployment of the device 100.

[0060] In addition, or optionally, the frame 110 of the device 100 is coated with at least one layer of coating. The coating layer can be selected from, but is not limited to, platinum, gold, etc. The coating layer on the frame 110 helps to visualize the device 100 using fluorescence imaging techniques after and / or during deployment of the device 100.

[0061] The frame 110 of the device 100 may be partially or completely covered by at least one cover 150. In an exemplary embodiment, as shown in Figure 1, the frame 110 is at least partially covered by the cover 150.

[0062] The cover 150 can extend from the first jacket (120a) toward the distal end (130) and covers 60% to 90% of the length of the frame 110. In exemplary embodiments, the cover 150 is made of polyethylene terephthalate (PET) fabric. The cover 150 helps to block the flow of blood through the vascular opening after the device 100 has been deployed in the vascular opening.

[0063] Figure 3 illustrates an exemplary method 300 for fabricating the device 100 of the present invention.

[0064] Method 300 begins in step 301 with braiding multiple monofilaments to obtain a braided structure (not shown). In an exemplary embodiment, a braided structure is obtained by braiding nitinol wires.

[0065] In exemplary embodiments, the Nitinol wire is braided using an automated braiding machine having a range of 36 to 70 pairs of carriers, depending on the size of the device 100. Each pair of carriers defines an angle between them ranging from 110° to 140°.

[0066] In step 303, the braided structure was subjected to a primary shaping process at a predetermined temperature for a predetermined duration. The predetermined temperature ranged from 500°C to 515°C. The predetermined duration ranged from 20 minutes to 25 minutes. In an exemplary embodiment, the braided structure was exposed to a temperature of 505°C for 20 minutes. The primary shaping process contributes to imparting strength to the device 100.

[0067] In step 305, the braided structure is subjected to a forming treatment. The forming treatment helps to define the multiple parts of the frame 110 (as described above).

[0068] In an exemplary embodiment, the molding process is carried out by attaching the braided structure to a mold. The mold has a shape corresponding to the frame 110 of the device 100.

[0069] In step 307, the free ends of the monofilaments at the distal end 130 of the frame 110 are welded together. Other functionally equivalent means of joining the monofilaments together are within the scope of the teachings of the present invention. In an exemplary embodiment, the free ends of the nitinol wire at the distal end 130 of the frame 110 are welded using a laser welding machine.

[0070] In step 309, the frame 110 is subjected to a secondary morphogenesis process at a predetermined temperature and for a predetermined duration. The predetermined temperature is in the range of 505°C to 515°C. The predetermined duration is in the range of 7 to 20 minutes. In an exemplary embodiment, the frame 110 was exposed to a temperature of 505°C for 10 minutes. The secondary morphogenesis process contributes to determining the shape / structure of the device 100.

[0071] In step 311, the free ends of the monofilaments at the proximal end 120 of the frame 110 are welded together. Other functionally equivalent means of joining the monofilaments together are within the scope of the teachings of the present invention. In an exemplary embodiment, the free ends of the nitinol wire at the proximal end 120 of the frame 110 are welded using a laser welding machine.

[0072] In step 313, the first jacket 120a and the second jacket 130a are welded to the proximal end 120 and the distal end 130, respectively. Other functionally equivalent means for joining the first jacket 120a and the second jacket 130a to the frame 110 are within the scope of the teachings of the present invention. In exemplary embodiments, the first jacket 120a and the second jacket 130a are welded to the proximal end 120 and the distal end 130, respectively, using a laser welding machine.

[0073] In step 315, the cover 150 is joined to the frame 110. In an exemplary embodiment, the cover 150 is sewn to the frame 110 via sutures. The cover 150 helps to block the flow of blood through the vascular opening after the device 100 has been deployed in the vascular opening. The sutures may be made of monofilament or multifilament material selected from at least one of polyester, polymer, nylon, etc. In an exemplary embodiment, the sutures are made of polyester. In an exemplary embodiment, a cup-shaped polyethylene terephthalate (PET) fabric is sewn to the frame 110 to cover 75% to 80% of the frame 110. The cover 150 extends from the first jacket 120a toward the distal end 130 of the frame 110.

[0074] In step 317, the barb 140 is attached to the frame 110. In an exemplary embodiment, as shown in Figure 1, the barb 140 is sutured symmetrically around the third portion 110c of the frame 110 according to a three-layer suture pattern. The three-layer suture of the barb 140 prevents the barb 140 from coming loose (or being damaged) during loading / deployment of the device 100. The barb 140 helps the device 100 engage with the surrounding tissue of the vascular opening, thereby preventing movement of the device 100 and providing long-term stability to the device 100 after deployment.

[0075] In an optional step 319, the delivery wire is removably coupled to the first jacket 120a of the device 100. In an exemplary embodiment, the delivery wire is screwed into the first jacket 120a of the device 100. The delivery wire helps the user push the device 100 toward the implantation site.

[0076] In an optional step 321, the device 100 is loaded into the loader along with the delivery wire. In an exemplary embodiment, the frame device 100 is radially compressed to its compressed state and loaded into the loader. The loader is then used to introduce the device 100 into the catheter of the delivery system. The catheter guides the device 100 to the implantation site.

[0077] Example 1 (Prior Art): A double-disc closure device was implanted in a vascular opening. The jacket of the closure device protruded from the frame, causing trauma to the surrounding tissue of the vascular opening. Due to the presence of a double disc in the closure device (i.e., the length of the closure device), it took a very long time to deploy it in the vascular opening.

[0078] Example 2 (Invention): The catheter was advanced to the vascular opening via a guidewire. After the delivery catheter reached the opening of the left atrial appendage, the guidewire was withdrawn from the catheter. The first jacket 120a of the device 100 was coupled to the delivery wire and loaded into the catheter using a loader. The device 100 (together with the delivery wire) was advanced within the catheter to the left atrial appendage. The catheter was withdrawn while keeping the device 100 and the delivery wire stationary. During the withdrawal of the catheter, the device 100 gradually self-expanded. Because the proximal end 120 of the frame 110 is cup-shaped, it was easy to then advance the delivery catheter over the device 100 to re-capture and reposition the device 100 in the left atrial appendage. The catheter was withdrawn again, allowing the device 100 to self-expand in the left atrial appendage. The return 140 of the device 100 engaged uniformly with the surrounding tissue of the left atrial appendage, thereby preventing movement of the device 100 and providing long-term stability of the device 100 after deployment. The frame 110 provided a strong grip and strength against the surrounding tissue, resulting in a tight fit of the device 100 at the vascular opening. Due to the frame's structure, there was no contact between the first jacket 120a and the second jacket 130a and the surrounding tissue. The delivery wire was rotated counterclockwise to detach it from the device 100. With the device 100 still implanted in the left atrial appendage, the delivery wire, along with the catheter, was retracted from the left atrial appendage. The proximal end 120 of the frame 110 contributed to early endothelialization.

[0079] The scope of the present invention is limited only by the appended claims. More generally, those skilled in the art will readily understand that all parameters, dimensions, materials, and configurations described herein are intended to be illustrative, and that actual parameters, dimensions, materials, and / or configurations will depend on the specific application in which the teachings of the present invention are used.

Claims

1. a. A frame (110) extending between a proximal end (120) and a distal end (130), having a predetermined length, and comprising a plurality of parts, wherein the plurality of parts of the frame (110) are at least A first portion (110a) is provided at the distal end (130) and forms a predetermined angle "f" with the distal end (130), the predetermined angle "f" being in the range of 30° to 80°. A second part (110b) is provided adjacent to the first part (110a) and forms a predetermined angle "s" with the distal end (130), the predetermined angle "s" being in the range of 120° to 140°. A third portion (110c) is provided adjacent to the second portion (110b), forming a predetermined angle "t" with the distal end (130), the predetermined angle "t" being in the range of 30° to 90°, and The frame (110) includes a fourth portion (110d) which is disposed at the proximal end (120) and forms a predetermined angle "o" with the distal end (130), the predetermined angle "o" being in the range of 110° to 135°, b. A first jacket (120a) coupled to the proximal end (120), the first jacket (120a) being at least partially surrounded by at least one of the third portion (110c) and the fourth portion (110d), c. A second jacket (130a) coupled to the distal end (130), which is at least partially surrounded by the first portion (110a), A device (100) comprising the above.

2. The device (100) according to claim 1, wherein a cover (150) extends from the first jacket (120a) toward the distal end (130) of the frame (110) and covers at least 60% to 90% of the length of the frame (110).

3. The device (100) according to claim 1, wherein a plurality of returns (140) are coupled to at least one of the plurality of parts of the frame (110).

4. The device (100) according to claim 1, wherein the first portion (110a) is convex.

5. The device (100) according to claim 1, wherein the second portion (110b) is concave.

6. The device (100) according to claim 1, wherein the third portion (110c) tapers outward from the distal end (130) toward the proximal end (120).

7. The device (100) according to claim 1, wherein the fourth portion (110d) tapers inward from the distal end (130) toward the proximal end (120).

8. The device (100) according to claim 1, wherein the fourth portion (110d) is curved at the proximal end (120) and extends at least partially toward the distal end (130).

9. The device (100) according to claim 8, wherein the proximal end (120) defines a predetermined angle "p" with the distal end (130), and the predetermined angle "p" is in the range of 70° to 100°.

10. The device (100) according to claim 1, wherein the first jacket (120a) is provided with a plurality of threads that are detachably coupled to a delivery wire.

11. The device (100) according to claim 1, wherein the frame (110) is made of a braided monofilament or multifilament selected from nitinol, drawn-filled tube (DFT) wire, and / or tungsten.

12. The device (100) according to claim 11, wherein the multiple braided monofilaments or multifilaments of the frame (110) define a braiding angle "b" in the range of 110° to 140°.

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