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 Life Sciences Pvt. Ltd., an Indian company of the address Survey No. 135/139 Bilakhia House, Muktanand Marg, Chala, Vapi-Gujarat 396191, India.

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

FIELD OF INVENTION
[001] The present invention relates to a medical device. More specifically, the present invention relates to a percutaneous closure device for sealing a vascular tissue.
BACKGROUND OF INVENTION
[002] The heart is the principal organ of the blood circulatory system. The heart includes four compartments (or chambers) which contracts in a rhythmic way to circulate (or pump) blood throughout the body. The left atrium chamber includes an extension in the form of a small pocket like structure which is also known as the left atrial appendage (LAA). Ideally, in a healthy individual, the LAA is not part of the blood circulatory system.
[003] High cholesterol deposits are known to be linked to blood clot (or thrombus) formation. This clot formation may occur anywhere within the blood circulatory system including inside the LAA of the left atrium. Thrombus within the LAA leads to atrial fibrillation (a type of cardiac arrhythmia).
[004] Irregular pumping of heart due to chronic atrial fibrillation leads to insufficient amount of blood being pumped from the left atrial chamber. Thus, the LAA retains the left-over blood that is not being pumped out of the left atrial chamber. This left-over blood within the LAA significantly increases the size of the clot within the LAA. The clot when stagnant inside the LAA will not result in any obstruction of pathway of capillary vessels. However, when the clot starts to break into smaller particles, it will lead to prolapse of the clot into the blood circulatory system impeding the flow of blood to any part of the vasculature (like brain) which results in stroke (like ischemic stroke).
[005] To reduce the risk of heart stroke, the LAA is removed through an open-heart surgery during a coronary bypass surgery or valve surgery. However, the risk of open-heart surgery being fatal to the individual is always high and is preferred as a last resort of treatment.
[006] Left Atrial Appendage Closure (LAAC) devices were recently introduced for patients who were not suitable for open-heart surgeries. LAAC device implantation is a minimally invasive procedure that is used to reduce the risk of stroke that results from atrial fibrillation (also known as Afib or AF).
[007] The LAA is in continuous movement due to rhythmic contraction and dilation of the pumping/palpitating heart. Further, the flow of blood makes the LAA slippery thereby creating difficulties in correct positioning of conventional LAAC device during deployment procedure. More often than not, it leads to imprecise deployment of the LAAC device during implantation and/or migration of the LAAC device post deployment.
[008] Thus, there is a need for an improved closure device which overcomes the aforementioned challenges associated with the conventional devices.
SUMMARY OF INVENTION
[009] 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.
[0010] The present invention relates to a device including a frame, a first jacket and a second jacket. The frame has a pre-defined length and extends between a proximal end and a distal end. The frame has a plurality of portions including at least, a first portion, a second portion, a third portion, and a fourth portion. The first portion is disposed at the distal end and makes a pre-defined angle ‘f’ with the distal end ranging from 30° to 80°. The second portion is disposed adjacent to the first portion and makes a pre-defined angle ‘s’ with the distal end ranging from 120° to 140°. The third portion is disposed adjacent to the second portion and makes a pre-defined angle ‘t’ with the distal end ranging from 30° to 90°. The fourth portion is disposed at the proximal end and makes a pre-defined angle ‘o’ with the distal end ranging from 110° to 135°. The first jacket is coupled to the proximal end and is at least partially surrounded by at least one of the third portion and the fourth portion. The second jacket is coupled to the distal end and is at least partially surrounded by the first portion.
BRIEF DESCRIPTION OF DRAWINGS
[0011] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[0012] Fig. 1 depicts a device 100 in accordance with an embodiment of the present invention.
[0013] Fig. 2 depicts a frame 110 of the device 100 in accordance with an embodiment of the present invention.
[0014] Fig. 3 illustrates a method 300 of making the device 100 in accordance with an embodiment of the present invention.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0015] Prior to describing the invention in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have a property of, or the like. Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases.
[0016] 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.
[0017] 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.
[0018] 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.
[0019] The present invention discloses a closure device (or device). The device may be used for closure of a vascular orifice. In an exemplary embodiment, the device is implanted at an entrance (or ostium) of the left atrial appendage (LAA) of the heart.
[0020] The device of the present invention includes a single lobed structure. The single lobed structure of the device helps in easy loading and re-capturing of the device. The single lobed structure of the device further helps to reduce deployment time during implantation of the device at the vascular orifice.
[0021] The device of the present invention introduces less metallic material inside the body compared to conventional devices. The device of the present invention is flexible enough to conform to various types of vascular orifices. The device may seal vascular orifices having a landing zone diameter ranging from 16 mm to 38 mm. The landing zone diameter is an intrinsic property of the vascular orifice which is manually determined via, for example, echocardiographic images of the vascular orifice.
[0022] The device includes a frame made by braiding monofilaments (or multi-filaments). The loose ends of the frame at the proximal end and the distal end are secured via a first jacket and a second jacket. The first and second jackets provide and maintain the structural integrity and strength of the frame and the device.
[0023] The monofilaments, at the distal end, are curved within the frame such that the monofilaments axially extend at least partially towards the proximal end of the frame. Thus, the second jacket is disposed within the frame 110, thereby, minimizing metal contact with the surrounding tissue at the vascular orifice.
[0024] The device has a cup-shaped proximal end which helps to completely recapture, reposition and redeploy the device thus, enabling the user to precisely deploy the device at the vascular orifice. Further, the cup-shape of the proximal end prevents and/or minimizes metal contact of a first jacket with the surrounding tissue at the vascular orifice when the device is deployed. The proximal end of the frame 110 helps in early endothelization as well.
[0025] A first portion of the frame helps the device to snugly fit within the vascular orifice to minimize the risk of migration of the device. A third portion of the frame provides the device with strength against surrounding tissue at the implantation site thereby preventing the device from migrating from the implantation site after the device is deployed. A fourth portion of the frame provides strong grip to the device at the vascular orifice, when the device is deployed.
[0026] The device is provided with a plurality of barbs that help the device to engage with the surrounding tissue of the vascular orifice thereby, preventing device migration and providing long-term stability to the device after deployment. The J-shaped anchors of the barbs prevents dislodgement (or damage) of the barbs during loading/deploying the device.
[0027] The barbs, during loading the device via a sheath, straightens out within a concave shape of a second portion of the frame, thus, helping in smooth loading of the device.
[0028] Now referring to the figures, Fig. 1 depicts an exemplary embodiment of a device 100 of the present invention. The device 100 includes a frame 110 extending between a proximal end 120 and a distal end 130. Further, the device 100 may be provided with a plurality of barbs 140 and/or at least one cover 150.
[0029] The frame 110 of the device 100 is depicted in Fig. 2. The frame 110 may be radially collapsible to a crimped state for navigating the device 100 inside a human body to the vascular orifice. The frame 110 may be radially expandable to an expanded state when the device 100 is deployed at the vascular orifice. The frame 110 may be made by braiding a plurality of monofilaments or a plurality of multifilaments. The monofilaments and/or the multifilaments of the frame 110 may be made of a self-expandable material such as, nitinol, tungsten, etc. or other composite materials used in, for example, drawn filled tubing (DFT) wires, etc. In an exemplary embodiment, the drawn filled tubing wires provide radiopacity, shape retention, and good strength via a single wire. In an exemplary embodiment, the frame 110 is made by braiding nitinol monofilaments. The monofilaments may have a pre-defined diameter ranging from 70 microns to 300 microns. In an exemplary embodiment, the diameter of the monofilament is 150 microns.
[0030] The plurality of monofilaments may be braided at a pre-defined braiding angle ‘b’. The braiding angle ‘b’ ranges from 110° to 140° depending on the size of the device 100. The said braiding angle ‘b’ ensures strength and integrity of the device 100. In an exemplary embodiment, the braiding angle ‘b’ ranges from 125° to 127°.
[0031] The plurality of monofilaments may be coupled 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 an exemplary embodiment, the first and second jackets 120a, 130a are welded to the monofilaments at the proximal and distal ends 120, 130 respectively. The first and second jackets 120a, 130a provide and maintain the structural integrity and strength of the frame 110 and the device 100. Other functionally equivalent means of coupling the first and second jackets 120a, 130a to the monofilaments are within the scope of the teachings of the present invention.
[0032] In an exemplary embodiment, the monofilaments are braided from the proximal end 120 to the distal end 130. Thereafter, the monofilaments are curved within the frame 110 such that the monofilaments axially extend at least partially towards the proximal end 120. The loose ends of the monofilaments are then welded together at the distal end 130 enabling the second jacket 130a to be disposed within the frame 110. This helps to minimize metal contact with the surrounding tissue at the vascular orifice.
[0033] The first and second jackets 120a, 130a may be made of a material including but not limited to stainless steel, platinum iridium, platinum tungsten, tantalum, etc. The material of the first and second jackets 120a, 130a may have a thickness ranging from 150 microns to 180 microns. In an exemplary embodiment, the first and second jackets 120a, 130a are made of 150 microns thick stainless steel. The first and second jackets 120a, 130a maintains integrity of the frame 110 and the device 100. The first and second jackets 120a, 130a enable the device 100 to be imaged/viewed under fluoroscopy imaging techniques post and/or during implantation of the device 100.
[0034] The first jacket 120a, towards the proximal end 120, may be provided with a plurality of internal threads (not shown). The plurality of internal threads of the first jacket 120a may be removably coupled to a delivery wire of a delivery system. The delivery system is used to deploy the device 100 at the vascular orifice (described later). Other functionally equivalent means to couple the delivery wire to the first jacket 120a are within the scope of the teachings of the present invention.
[0035] A lateral cross-section of the frame 110 may have a pre-defined shape including but not limited to circular, crown-like, oval, etc. In an exemplary embodiment, the lateral cross section of the frame 110 is circular shaped.
[0036] Similarly, an axial cross-section of the frame 110 may have a pre-defined shape including but not limited to hourglass, apple, ellipse, oval, circular diamond, etc. In an exemplary embodiment, as shown in Fig. 2, the axial cross-section of the frame 110 is hourglass shaped. The frame 110 may have a pre-defined length ranging from 8 mm to 26 mm. In an exemplary embodiment, the length of the frame 110 is 16 mm.
[0037] The frame 110 at the distal end 130 may be flat, tapered, convex or concave. In an exemplary embodiment, as shown in Fig. 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 to be held at the vascular orifice, thereby covering and sealing the entire vascular orifice where the device 100 is deployed.
[0038] 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 Fig. 2, the frame 110 includes a first portion 110a, a second portion 110b, a third portion 110c and a fourth portion 110d.
[0039] Although the frame 110 is described with the plurality of portions, the frame 110 is an integral structure. Alternatively, the frame 110 may have discrete portions that are either fixedly or removably coupled to each other and the same is within the scope of the teachings of the present invention.
[0040] The first portion 110a may be disposed at the distal end 130 of the frame 110. The frame 110 at the first portion 110a may be flat, tapered, convex or concave. In an exemplary embodiment, as shown in Fig. 2, the first portion 110a of the frame 110 is convex shaped. The frame 110 at the first portion 110a may have a maximum diameter ranging from 16 mm to 38 mm. In an exemplary embodiment, the maximum diameter of the frame 110 at the first portion 110a is 28 mm. The frame 110 at the first portion 110a may have a length 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 snugly fit the vascular orifice to minimize the risk of migration of the device 100.
[0041] The lower end of the first portion 110a of the frame 110 may define a pre-defined angle ‘f’ with respect to an axis ‘fx’ parallel to the distal end 130 of the frame 110. The pre-defined angle ranges from 30° to 80°. In an exemplary embodiment, the pre-defined angle ‘f’ defined by the lower end of the first portion 110a of the frame 110 is 41°.
[0042] In an exemplary embodiment, as shown in Fig. 2, the second jacket 130a is at least partially surrounded by the first portion 110a of the frame 110. This helps to minimize metal contact with the surrounding tissue at the vascular orifice.
[0043] The second portion 110b may be disposed adjacent to the first portion 110a. The frame 110 at the second portion 110b may be flat, tapered, convex or concave. In an exemplary embodiment, as shown in Fig. 2, the second portion 110b of the frame 110 is concave shaped. The frame 110 at the second portion 110b may have a minimum diameter ranging from 13 mm to 33 mm. In an exemplary embodiment, the minimum diameter of the frame 110 at the second portion 110b is 24 mm. The frame 110 at the second portion 110b may have a length ranging from 3 mm to 8 mm. In an exemplary embodiment, the length of the second portion 110b is 5 mm.
[0044] The lower end of the second portion 110b of the frame 110 may define a pre-defined angle ‘s’ with respect to an axis ‘sx’ parallel to the distal end 130 of the frame 110. The pre-defined angle ranges from 120° to 140°. In an exemplary embodiment, the pre-defined angle ‘s’ defined by the lower end of the second portion 110b of the frame 110 is 120°.
[0045] The third portion 110c may be disposed adjacent to the second portion 110b. The frame 110 at the third portion 110c may be flat, tapered, convex or concave. In an exemplary embodiment, as shown in Fig. 2, the third portion 110c of the frame 110 tapers out from the distal end 130 towards the proximal end 120. The frame 110 at the third portion 110c may have a maximum diameter towards the proximal end 120 and a minimum diameter towards the distal end 130. The minimum diameter of the third portion 110c ranges from 14 mm to 36 mm. The maximum diameter of the third portion 110c ranges from 16 mm to 38 mm. In an exemplary embodiment, the minimum and maximum diameter of the third portion 110c are 26 and 28 respectively. The frame 110 at the third portion 110c may have a length ranging from 0.5 mm to 1.5 mm. In an 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 against surrounding tissue at the implantation site thereby preventing the device 100 from migrating from the implantation site after the device 100 is deployed.
[0046] The lower end of the third portion 110c of the frame 110 may define a pre-defined angle ‘t’ with respect to an axis ‘tx’ parallel to the distal end 130 of the frame 110. The pre-defined angle ranges from 30° to 90°. In an exemplary embodiment, the pre-defined angle ‘t’ defined by the lower end of the third portion 110b of the frame 110 is 80°.
[0047] The fourth portion 110d may be disposed adjacent to the third portion 110c and at the proximal end 120. The frame 110 at the fourth portion 110d may be flat, tapered, convex or concave. In an exemplary embodiment, as shown in Fig. 2, the fourth portion 110d of the frame 110 tapers in from the distal end 130 towards the proximal end 120. The frame 110 at the fourth portion 110c may have a maximum diameter towards the distal end 130 and a minimum diameter towards the proximal end 120. The minimum diameter of the fourth portion 110d ranges from 8 mm to 22 mm. The maximum diameter of the fourth portion 110d ranges from 16 mm to 38 mm. In an exemplary embodiment, the minimum and maximum diameter of the fourth portion 110d are 16 and 28 respectively. The frame 110 at the fourth portion 110d may have a length ranging from 2 mm to 10 mm. In an exemplary embodiment, the length of the fourth portion 110d is 6 mm at an angle of 130°. The fourth portion 110d provides strong grip to the device 100 at the vascular orifice, when the device 100 is deployed.
[0048] The lower end of the fourth portion 110d of the frame 110 may define a pre-defined angle ‘o’ with respect to an axis ‘ox’ parallel to the distal end 130 of the frame 110. The pre-defined angle ranges from 110° to 135°. In an exemplary embodiment, the pre-defined angle ‘o’ defined by the lower end of the fourth portion 110d of the frame 110 is 117°.
[0049] In an exemplary embodiment, as shown in Fig. 2, the frame 110 at the third portion 110c and the fourth portion 110d resembles a crown-like shape. The crown-like shape of the frame 110 is always at least 20% to 30% greater than the vascular orifice where the device 100 is to be deployed. Thus, the crown-like shape of the frame 110 helps in firm affixation of the device 100 at the vascular orifice thereby preventing the device 100 to dislocate/migrate from the vascular orifice.
[0050] In an embodiment, the fourth portion 110d as shown in Fig. 2, is curved at the proximal end 120 and at least partially extends towards the distal end 130, thereby making a cup-shaped proximal end 120. The cup-shaped proximal end 120 has a tapered profile. The cup-shape of the proximal end 120 prevents and/or minimizes metal contact of the first jacket 120a with the surrounding tissue at the vascular orifice when the device 100 is deployed (described below).
[0051] Although the proximal end 120 of the device 100 is described to have a cup-shape, other functionally equivalent shape of the proximal end 120 is within the scope of the teachings of the present invention.
[0052] The proximal end 120 of the frame 110 may define a pre-defined angle ‘p’ with respect to an axis ‘px’ parallel to the distal end 130 of the frame 110. The pre-defined angle ranges from 70° to 100°. In an exemplary embodiment, the pre-defined angle ‘p’ defined by the proximal end 120 of the frame 110 is 75°.
[0053] In an exemplary embodiment, due to the cup-shape of the proximal end 120 as shown in Fig. 2, the first jacket 120a is laterally surrounded at least by one of the third portion 110c and fourth portion 110d of the frame 110. This helps to minimize metal contact with the surrounding tissue at the vascular orifice and enhances endothelization of the device 100 post 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, a force required for loading/recapturing the device 100 (for example, within a catheter of the delivery system) by pulling the delivery wire (removably coupled to the first jacket 120a) is significantly reduced. This enables the user to easily reposition and redeploy the device 100 at the vascular orifice to ensure accurate deployment of the device 100.
[0054] The frame 110 at the proximal end 120 may be flat, tapered, convex or concave. In an exemplary embodiment, as shown in Fig. 2, the proximal end 120 of the frame 110 is cup-shaped (or scalloped). The cup-shaped proximal end 120 also helps to completely recapture, reposition and redeploy the device 100 (as described above) thus, enabling the user to precisely deploy the device 100 at the vascular orifice. The proximal end 120 of the frame 110 helps in early endothelization.
[0055] As shown in Fig. 1, the frame 110 may be provided with the plurality of barbs 140. The barbs 140 may be coupled to at least one of the portions of the frame 110 by at least one of stitching, welding, crimping, etc. The barbs 140 may circumferentially disposed around the frame 110. The barbs 140 may be disposed equidistantly from each other. In an exemplary embodiment, as shown in Fig. 1, the barbs 140 are stitched symmetrically around the second portion 110b and the third portion 110c of the frame 110 such that the device 100 is able to uniformly engage with the surrounding tissue of the vascular orifice.
[0056] In an exemplary embodiment, the barbs 140, during loading the device 100 via a sheath, straightens out within the concave shape of the second portion 110b of the frame 110. In other words, the second portion 110b helps in smooth loading of the device 100.
[0057] The barbs 140 may be made of material including but not limited to nitinol, stainless steel, etc. In an exemplary embodiment, the barbs 140 are made of nitinol. The barbs 140 help the device 100 to engage with the surrounding tissue of the vascular orifice thereby, preventing device 100 migration and providing long-term stability to the device 100 after deployment.
[0058] The device 100 includes 4 to 10 barbs 140. In an exemplary embodiment, each barb 140 includes 2 J-shaped anchors. The J-shaped anchors of the barbs 140 prevents dislodgement (or damage) of the barbs 140 during loading/deploying the device 100.
[0059] In an exemplary embodiment, the device 100 is provided with six barbs 140. Accordingly, the device 100 includes twelve J-shaped anchors.
[0060] Other functionally equivalent shape of the anchors of the barb 140 are within the scope of the teachings of the present invention.
[0061] Additionally or optionally, the barbs 140 may be provided with one or more radiopaque markers. In an exemplary embodiment, each of the barb 140 is provided with coil marker. The radiopaque marker may be made of a material including but not limited to platinum iridium, platinum tungsten, tantalum, stainless steel, etc. In an exemplary embodiment, the radiopaque markers are made of stainless steel. The radiopaque marker helps to visualize the device 100 using fluoroscopy imaging techniques after and/or during deployment of the device 100.
[0062] Additionally or optionally, the frame 110 of the device 100 is coated with at least one layer of coating. The layer of coating may be selected from, but not limited to, platinum, gold, etc. The layer of coating on the frame 110 helps to visualize the device 100 using fluoroscopy imaging techniques after and/or during deployment of the device 100.
[0063] The frame 110 of the device 100 may partially or completely be covered with at least one cover 150. In an exemplary embodiment, as shown in Fig. 1, the frame 110 is partially covered by a cover 150.
[0064] The cover 150 may extend from the first jacket (120a) towards the distal end (130) and covers 60% to 90% of the length of the frame 110. In an exemplary embodiment, the cover 150 is made of Polyethylene terephthalate (PET) fabric. The cover 150 helps to block flow of blood through the vascular orifice after the device 100 is deployed at the vascular orifice.
[0065] Fig. 3 depicts an exemplary method 300 of making the device 100 of the present invention.
[0066] The method 300 commences at step 301 by braiding a plurality of monofilaments to obtain a braided structure (not shown). In an exemplary embodiment, the nitinol wires are braided to obtain the braided structure.
[0067] In an exemplary embodiment, the nitinol wires are braided using automatic braiding machine having carriers ranging from 36 pairs to 70 pairs depending on the size of the device 100. Each pair of carriers define an angle ranging from 110° to 140° between them.
[0068] At step 303, the braided structure was subjected to a primary shape setting process at a pre-defined temperature for a pre-defined time period. The pre-defined temperature ranges from 500 °C to 515 °C. The pre-defined time period ranges from 20 minutes to 25 minutes. In an exemplary embodiment, the braided structure was subjected to a temperature of 505 °C for 20 minutes. The primary shape setting process helps to impart strength to the device 100.
[0069] At step 305, the braided structure is subjected to a molding procedure. The molding procedure helps to define the plurality of portions of the frame 110 (as described above).
[0070] In an exemplary embodiment, the molding procedure is performed by attaching braided structure to a mold. The mold has a shape corresponding to the frame 110 of the device 100.
[0071] At step 307, the loose ends of the monofilaments at the distal end 130 of the frame 110 are welded together. Other functionally equivalent means of coupling the monofilaments together are within the scope of the teachings of the present invention. In an exemplary embodiment, the loose ends of the nitinol wires at the distal end 130 of the frame 110 are welded using a laser welding machine.
[0072] At step 309, the frame 110 is subjected to a secondary shape setting process for a pre-defined temperature and a pre-defined time period. The pre-defined temperature ranges from 505 °C to 515 °C. The pre-defined time period ranges from 7 minutes to 20 minutes. In an exemplary embodiment, the frame 110 was subjected to a temperature of 505 °C for 10 minutes. The secondary shape setting process helps to set the shape/structure of the device 100.
[0073] At step 311, the loose ends of the monofilaments at the proximal end 120 of the frame 110 are welded together. Other functionally equivalent means of coupling the monofilaments together are within the scope of the teachings of the present invention. In an exemplary embodiment, the loose ends of the nitinol wires at the proximal end 120 of the frame 110 are welded using a laser welding machine.
[0074] At 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 of coupling the first and second jackets 120a, 130a with the frame 110 are within the scope of the teachings of the present invention. In an exemplary embodiment, 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.
[0075] At step 315, the cover 150 is coupled to the frame 110. In an exemplary embodiment, the cover 150 is stitched to the frame 110 via sutures. The cover 150 helps to block flow of blood through the vascular orifice after the device 100 is deployed at the vascular orifice. The sutures may be made of a monofilament or multifilament material selected from at least one of, polyester, polymer, nylon, etc. In an exemplary embodiment, the suture is made of polyester. In an exemplary embodiment, a cup-shaped Polyethylene terephthalate (PET) fabric is stitched to the frame 110 covering 75% to 80% of the frame 110. The cover 150 extends from the first jacket 120a towards the distal end 130 of the frame 110.
[0076] At step 317, the barbs 140 are coupled to the frame 110. In an exemplary embodiment, as shown in Fig. 1, the barbs 140 are stitched symmetrically around the third portion 110c of the frame 110 by following a three-layer stitching pattern. The three-layer stitching of the barbs 140 prevents dislodgement (or damage) of the barbs 140 during loading/deploying the device 100. The barbs 140 help the device 100 to engage with the surrounding tissue of the vascular orifice thereby, preventing device 100 migration and providing long-term stability to the device 100 after deployment.
[0077] At an optional step 319, a delivery wire is removably coupled to the first jacket 120a of the device 100. In an exemplary embodiment, the delivery wire is screwed in the first jacket 120a of the device 100. The delivery wire helps the user to push the device 100 towards the implantation site.
[0078] At an optional step 321, the device 100 along with the delivery wire is loaded within a loader. In an exemplary embodiment, the frame device 100 is radially collapsed to its crimped state and loaded inside the loader. The loader is then used to introduce the device 100 within a catheter of a delivery system. The catheter guides the device 100 to the implantation site.
[0079] Example 1 (Prior art): A double disc closure device was implanted at the vascular orifice. The jackets of the closure device were protruding out of the frame which caused trauma to the surrounding tissue of the vascular orifice. Due to the presence of a double disc (i.e., long length of the closure device) in the closure device, it took a very long time to deploy at the vascular orifice.
[0080] Example 2 (Present invention): A catheter was advanced over a guide wire to the vascular orifice. Once the delivery catheter reached the ostium of the left atrial appendage, the guide wire was retracted from within the catheter. The first jacket 120a of the device 100 was coupled to a delivery wire and loaded inside the catheter by using a loader. The device 100 (along with the deliver wire) was advanced within the catheter to the left atrial appendage. The catheter was pulled back while keeping the device 100 and the delivery wire stationary. While the catheter was pulled back, the device 100 progressively self-expanded. Due to the cup-shaped proximal end 120 of the frame 110, the delivery catheter was then advanced over the device 100 to easily recapture and reposition the device 100 at the left atrial appendage. The catheter was again pulled back to enable the device 100 self-expand at the left atrial appendage. The barbs 140 of the device 100 uniformly engaged the surrounding tissue of the left atrial appendage, thereby, preventing device 100 migration and providing long-term stability to the device 100 after deployment. The frame 110 provided a snug fit and of the device 100 at the vascular orifice with strong grip and strength against the surrounding tissue. Due to the structure of the frame, there was no contact between the first and second jackets 120a, 130a and the surrounding tissue. The delivery wire was rotated in an anti-clockwise direction to disengage the delivery wire from the device 100. The delivery wire along with the catheter was retracted from the left atrial appendage leaving the device 100 implanted at the left atrial appendage. The proximal end 120 of the frame 110 helped in early endothelization.
[0081] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM
1. A device (100), comprising:
a. a frame (110) extending between a proximal end (120) and a distal end (130), having a pre-defined length, and including a plurality of portions, the plurality of portions of the frame (110) including at least:
a first portion (110a) disposed at the distal end (130), making a pre-defined angle ‘f’ with the distal end (130), the pre-defined angle ‘f’ ranging from 30° to 80°,
a second portion (110b) disposed adjacent to the first portion (110a), making a pre-defined angle ‘s’ with the distal end (130), the pre-defined angle ‘s’ ranging from 120° to 140°,
a third portion (110c) disposed adjacent to the second portion (110b), making a pre-defined angle ‘t’ with the distal end (130), the pre-defined angle ‘t’ ranging from 30° to 90°, and
a fourth portion (110d) disposed at the proximal end (120), making a pre-defined angle ‘o’ with the distal end (130), the pre-defined angle ‘o’ ranging from 110° to 135°;
b. a first jacket (120a) coupled to the proximal end (120), the first jacket (120a) is at least partially surrounded by at least one of the third portion (110c) and the fourth portion (110d); and
c. a second jacket (130a) coupled to the distal end (130), the second jacket (130a) is at least partially surrounded by the first portion (110a).
2. The device (100) as claimed in claim 1, wherein a cover (150) extends from the first jacket (120a) towards the distal end (130) of the frame (110) covering at least 60% to 90% of a length of the frame (110).
3. The device (100) as claimed in claim 1, wherein a plurality of barbs (140) is coupled to at least one of the plurality of portions of the frame (110).
4. The device (100) as claimed in claim 1, wherein the first portion (110a) is convex shaped.
5. The device (100) as claimed in claim 1, wherein the second portion (110b) is concave shaped.
6. The device (100) as claimed in claim 1, wherein the third portion (110c) tapers out from the distal end (130) towards the proximal end (120).
7. The device (100) as claimed in claim 1, wherein the fourth portion (110d) tapers in from the distal end (130) towards the proximal end (120).
8. The device (100) as claimed in claim 1, wherein the fourth portion (110d) curves at the proximal end (120) and at least partially extends towards the distal end (130).
9. The device (100) as claimed in claim 8, wherein the proximal end (120) defines a pre-defined angle ‘p’ with the distal end (130), the pre-defined angle ‘p’ ranging from 70° to 100°.
10. The device (100) as claimed in claim 1, wherein the first jacket (120a) is provided with a plurality of threads removably coupled to a delivery wire.
11. The device (100) as claimed in claim 1, wherein the frame (110) is made by braided monofilaments or multifilaments selected from nitinol, drawn filled tubing (DFT) wires, and/or tungsten.
12. The device (100) as claimed in claim 11, wherein a plurality of braided monofilaments or multifilaments of the frame (110) define a braiding angle ‘b’ ranging from 110° to 140°.