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:
OCCLUDER DEVICE FOR CLOSING AN OPENING IN HEART
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 implant. More particularly, the present disclosure relates to an occluder device for closing an opening in heart.
BACKGROUND OF INVENTION
[002] Foramen Ovale (PFO) is a hole between the left and right atrium (upper chambers) of the heart. Every individual has this hole before birth, although it usually closes after birth. When the hole doesn’t heal itself naturally, the condition is known as Patent Foramen Ovale or Persistent Foramen Ovale (PFO). While most people with the PFO experience no symptoms, it can be associated with certain conditions. For example, many people suffer from migraine with aura, a type of migraine headache that is preceded by sensory disturbances called auras. These auras can include visual changes like flashes of light or blind spots, as well as sensory symptoms like tingling in the hands or face. While migraines are generally not life-threatening, they can significantly impact daily life. The PFO can also lead to decompression sickness in divers; and platypnea-orthodeoxia, a condition causing shortness of breath and low blood oxygen levels when upright. More serious consequences of the PFO include paradoxical embolism, where blood clots travel from the veins to the brain, causing stroke/ heart attack.
[003] To close such PFOs, pharmacological therapy includes oral anticoagulants or antiplatelet agents. These therapies may lead to side effects including bleeding. If pharmacologic treatment is unsuitable for a patient, the open-heart surgery may be employed to close a PFO with stitches. Like other open surgical treatments, this surgery is highly invasive, risky, and requires general anesthesia, which may result in procedural complexity. Moreover, the stitches may loosen up with time and the blood may move abnormally in the heart which is fatal for the patient.
[004] Minimally-invasive treatments to address the PFO condition include implanting an implant (also called as an occluder device) that closes the PFO. However, conventionally available occluder devices for closure of the PFO include large masses of foreign material, which may lead to unfavorable body adaptation of a device. The conventional occluder devices include two discs connecting to the septum wall in the left atrium and the right atrium respectively. Both the discs in the conventional devices are braided, leading to a bulky device and a complex structure. This makes the device challenging to implant because of the difficulty in their delivery through a catheter. Further, the complex structure of the device results in longer tissue coverage, leading to longer endothelialization time. Other disadvantages of conventional implants include improper alignment, which may lead to thrombus formation in the heart. Further, a fully braided device is also prone to migration, leading to potentially life-threatening complications for the patient. It has also been observed that fully-braided devices sometimes result in a partial closure, which may lead to clot formation and hemorrhage. Thus, fully-braided conventional devices are sub-optimal, impacting patient health and reducing overall success rate of these devices.
[005] Thus, there arises a need for an occluder device that overcomes the problems associated with the conventional devices.
SUMMARY OF INVENTION
[006] 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.
[007] The present disclosure relates to an occluder device configured to close an opening within a heart. In an embodiment, the occluder device includes a proximal support member and a distal support member. The distal support member is coupled to the proximal support member. The distal support member includes, a proximal tubular section, a distal tubular section and a plurality of U-shaped struts. The plurality of U-shaped struts is arranged radially between the proximal tubular section and the distal tubular section. Each of the plurality of struts comprises a first arm, a second arm and a connecting portion. The first arm is coupled to the proximal tubular section, and the second arm is coupled to the distal tubular section. The connecting portion couples the first arm and the second arm. The proximal support member is braided and the distal support member is laser-cut from a single tube made of a biocompatible, self-expanding material.
BRIEF DESCRIPTION OF DRAWINGS
[008] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[009] Fig. 1a depicts a perspective view of an occluder device 100, according to an embodiment of the present disclosure.
[0010] Fig. 1b depicts an exploded view of the occluder device 100, according to an embodiment of the present disclosure.
[0011] Figs. 2a-2c depicts the occluder device 100 implanted within a patient’s heart to close a PFO 180, according to an embodiment of the present disclosure.
[0012] Fig. 3 depicts a perspective view of a proximal support member 110, according to an embodiment of the present disclosure.
[0013] Fig. 3a depicts a front view of the proximal support member 110, according to an embodiment of the present disclosure.
[0014] Figs. 3b-3c depict an exemplary pre-defined pattern of a mesh 112 of the proximal support member 110, according to an embodiment of the present disclosure.
[0015] Fig. 4a depicts a perspective view of a distal support member 120, according to an embodiment of the present disclosure.
[0016] Fig. 4b depicts another perspective view of the distal support member 120, according to an embodiment of the present disclosure.
[0017] Fig. 4c depicts a perspective of the distal support member 120 showing two of a plurality of struts 121 of the distal support member 120, according to an embodiment of the present disclosure.
[0018] Fig. 4d depicts showing a first arm 121a and a second arm 121b of one strut 121, according to an embodiment of the present disclosure.
[0019] Fig. 4e depicts a rear view of the distal support member 120, according to an embodiment of the present disclosure.
[0020] Fig. 4f depicts a coupling between a pair of adjacent first arms 121a using a first link 127, according to the embodiment of the present disclosure.
[0021] Fig. 5a and Fig. 5b depict perspective views of a proximal jacket 140, according to an embodiment of the present disclosure.
[0022] Fig. 6 depicts a perspective view of a middle jacket 150, according to an embodiment of the present disclosure.
[0023] Fig. 7 depicts a perspective view of a distal jacket 160, according to an embodiment of the present disclosure.
[0024] Fig. 8 depicts a flowchart of an exemplary method 900 of fabricating the occluder device 100, according to an embodiment of the present disclosure.
[0025] Fig. 9 depicts a flowchart of an exemplary method 1000 of fabricating the proximal support member 110, according to an embodiment of the present disclosure.
[0026] Fig. 10 depicts a flowchart of an exemplary method 1100 of fabricating the distal support member 120, according to an embodiment of the present disclosure.
[0027] Figs. 11a and 11b depicts a side view of a delivery cable 10 of a delivery system, according to an embodiment of the present disclosure.
[0028] Fig. 12 depicts a flowchart of an exemplary method 1300 for delivering the occluder device 100, according to an embodiment of the present disclosure.
[0029] Fig. 13a depicts a partial deployment stage of the occluder device 100 showing the distal support member 120, according to the embodiment of the present disclosure.
[0030] Fig. 13b depicts a full deployment stage of the occluder device 100, according to the embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[0031] 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.
[0032] 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.
[0033] 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.
[0034] 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.
[0035] The present disclosure relates to an occluder device for the closure of the openings where abnormal blood flow occurs. The occluder device includes a proximal support member and a distal support member. In an embodiment, the proximal support member is braided from a plurality of wires and the distal support member is laser cut from a single tube made of a self-expanding, biocompatible material. The proximal support member (due to the braided construction) provides a better flexibility to the occluder device and the distal support member (due to the laser-cut construction) provides higher strength to the occluder device. Consequently, the proposed occluder device has a better performance compared to conventional devices that are fully braided, i.e., have two braided discs. The occluder device enhances flexibility and precision during implantation. The occluder device aims to improve patient outcomes by providing a more effective and adaptable closure of the patent foramen ovale (PFO), thereby reducing the risk of cardiac arrest/stroke. The occluder device provides enhanced adaptability, stability, and precision during closure procedures. The occluder device is easy to deploy thereby reducing procedural complexity and increasing patient comfort. The proposed occluder device does not migrate from the target site thereby improving patient safety and long-term outcomes in PFO closure interventions. Though the present disclosure has been explained in the context of closing the PFO as an example, the proposed occluder device can also be used for closing other openings in the heart, for example, atrial septal defects, ventricular septal defects, and patent ducts arteriosus.
[0036] Now, referring to Figures, Fig. 1a, and Fig. 1b depict a perspective view, and an exploded view, respectively, of an occluder device 100 configured to close an opening in a heart of a patient, according to an embodiment. In an embodiment, the occluder device 100 is used to close the PFO of a patient.
[0037] The occluder device 100 has a proximal end 100a and a distal end 100b. In an embodiment, the occluder device 100 includes a proximal support member 110, a distal support member 120, a proximal sealing member (not shown), a distal sealing member 130, a proximal jacket 140, a middle jacket 150, and a distal jacket 160. The proximal support member 110 is braided and the distal support member 120 is laser-cut. The proximal support member 110 is coupled to the distal support member 120. By placing the laser-cut distal support member 120 at the distal end 100b provides better anchoring and enables more precise control for deploying the occluder device 100. Further, by placing the braided proximal support member 110 at the proximal end 100a offers more flexibility and a better seal against the septal wall. Various components of the occluder device 100 work in synchronization for the effective closure of PFO as explained later. Figs. 2a – 2c illustrate the occluder device 100 implanted inside a patient’s heart to close a PFO 180, according to an embodiment. In this case, when the occluder device 100 is deployed, the proximal support member 110 resides in the left atrium and the distal support member 120 resides in the right atrium on either side of the PFO 180 such that the proximal support member 110 and the distal support member 120 sandwich the PFO 180. The proximal support member 110 contacts the septum wall in left atrium and the distal support member 120 contacts the septum wall in the right atrium. A new tissue grows over the occluder device 100 over time and the PFO 180 is closed. Thus, the occluder device 100 provides closure of the PFO 180.
[0038] It is to be noted, while the description herein states the proximal support member 110 is disposed in the left atrium and the distal support member 120 is disposed in the right atrium, their positions may be reversed, i.e., the proximal support member 110 and the distal support member 120 may reside in the right and the left atrium, respectively, without deviating from the scope of the invention. A surgeon may choose their deployment positions based upon the patient’s needs.
[0039] Fig. 3 depicts a perspective view of the proximal support member 110, according to an embodiment. Fig. 3a depicts a front view of the proximal support member 110. The proximal support member 110 is disposed at the proximal end 100a of the occluder device 100. The proximal support member 110 is braided. Due to the braided construction, the proximal support member 110 provides more flexibility to the occluder device 100 and better conforms to the connected septal wall, ensuring secure fit and minimizing tissue trauma. Further, the proximal support member 110 provides anchoring strength, ensuring adaption of heart movements for long term stability of the occluder device 100. In addition, the proximal support member 110 facilitates skin growth, leading to more effective closure of the PFO. The proximal support member 110 has a proximal end 110a and a distal end 110b. According to an embodiment, the proximal support member 110 has a disc-like shape. The proximal support member 110 includes a plurality of wires 111 (hereinafter, the wires 111) braided to form a mesh 112 having a pre-defined pattern and forming a central opening 112a extending from the proximal end 110a and the distal end 110b. The mesh 112 has a three-dimensional structure. The proximal support member 110 has a pre-defined length L1 and a pre-defined diameter D1. The pre-defined length L1 and the pre-defined diameter D1 may be chosen based upon requirements of a patient. In an embodiment, the pre-defined length L1 may range between 2 mm and 4 mm, and the pre-defined diameter D1 may range between 12 mm and 50 mm. In an example implementation, the pre-defined length L1 and the pre-defined diameter D1 are 3 mm and 25 mm, respectively. The wires 111 may be made of a biocompatible, shape-memory (or self-expanding) material, including, without limitation, nitinol, Ni-Ti-Cu, Ni-Ti-Pd, and Cu-Al-Ni, etc. In an exemplary embodiment, the wires 111 are made of nitinol. The number of wires 111 may be chosen based upon requirements. For ease of braiding process and to ensure uniformity, the number of wires 111 may be chosen such that the number is divisible by 6. In an embodiment, the number of wires 111 may be at least 48, preferably between 48 and 150. Specifically, the number of wires 111 may be one of: 48, 72 or 128. In an example implementation, the proximal support member 110 is formed by braiding seventy-two wires 111. The wires 111 may be braided using a pre-defined pattern, such as, 1:1, 1:2, 2:1, etc. In an embodiment, the wires 111 are braided in 1:1 pattern. The wires 111 may have a cross-sectional shape, such as, circular, square, rectangular, etc. In an embodiment, the wires 111 have a circular cross-section to avoid any edges and minimize trauma to surrounding tissues. The diameter of the wires 111 may range between 70 microns and 150 microns. In an example implementation, the diameter of the wires 111 is 100 microns.
[0040] Each wire 111 has a proximal section disposed towards the proximal end 110a, a distal section disposed towards the distal end 110b, and a middle section disposed between the proximal section and the distal section. In an embodiment, the proximal sections of the wires 111 are circumferentially aligned and coupled (e.g., welded) to form a proximal projection 110c of the proximal support member 110. Similarly, the distal sections of the wires 111 are circumferentially aligned and coupled (e.g., welded) to form a distal projection 110d of the proximal support member 110. The proximal section and the distal section of each of the wires 111 are at an axial distance and disposed diametrically opposite to each other. The middle section has a pre-defined shape such as, without limitation, spiral, helical, oval, zig-zag, sinusoidal, triangular, elliptical, etc. In an embodiment, the middle sections of two adjacent wires 111 cross each other so that when all wires 111 are braided, the mesh 112 having the pre-defined pattern is formed.
[0041] An exemplary pre-defined pattern of the mesh 112 is explained using Figs. 3b – 3c. It should not be considered as limiting and the wires 111 may be braided in any other pattern to form the mesh 112. For clarity, Figs. 3b and 3c illustrate three of the wires 111, namely, a first wire 111’, a second wire 111’’ and a third wire 111’’’. The first wire 111’ has the proximal section 111a’, the distal section 111b’ and the middle section 111c’ disposed between the proximal section 111a’ and distal section 111b’. Similarly, the second wire 111’’ has the proximal section 111a’’, the distal section 111b’’, and the middle section 111c’’ disposed between the proximal section 111a’’ and the distal section 111b’’, and the third wire 111’’’ has the proximal section 111a’’’, the distal section 111b’’’, and the middle section 111c’’’ disposed between the proximal section 111a’’’ and the distal section 111b’’’. As can be seen from Fig. 3b, the proximal sections 111a’, 111a’’, and the distal sections 111b’, 111b’’ of the first and second wires 111’, 111’’ are adjacent to each other. Similarly, the proximal sections 111a’’, 111a’’’, and the distal sections 111b’’, 111b’’’ of the second and third wires 111’’, 111’’’ are adjacent to each other.
[0042] Further, the middle sections 111c’, 111c’’, 111c’’’ of the first, second and third wires 111’, 111’’, 111’’’ have a pre-defined shape, such as, helical, spiral, triangular, parabolic, etc. In the depicted embodiment, the middle sections 111c’, 111c’’, 111c’’’ are helical. The middle sections 111c’ and 111c’’ of the first and second wires 111’, 111’’ cross each other at a point A’ (shown in Fig. 3c). Similarly, the middle sections 111c’’, 111c’’’ of the second and third wires 111’’, 111’’’ cross each other at a point A’’. In an embodiment, the middle section 111c’’ of the second wire 111’’ is disposed over the middle section 111c’ of the first wire 111’ at the point A’, and the middle section 111c’’’ of the third wire 111’’’ is disposed over the middle section 111c’’ of the second wire 111’’ at the point A’’, and so forth (as depicted in Fig. 3c). In another embodiment, the middle sections 111c’’, 111c’’’ of successive wires 111’’, 111’’’ may be disposed under the middle sections 111c’, 111c’’, respectively of preceding wires 111’, 111’’ at respective cross-over points.
[0043] In an embodiment, the length of the proximal sections (e.g., 111a’, 111a’’, 111a’’’) of the wires 111 may range between 20 mm and 70 mm, the length of the distal sections (e.g., 111b’, 111b’’, 111b’’’) of the wires 111 may range between 20 mm and 70 mm, and the length of the middle sections (e.g., 111c’, 111c’’, 111c’’’) may range between 20 mm and 70 mm. In an example implementation, the length of the proximal section (e.g., 111a’, 111a’’, 111a’’’), the distal section (e.g., 111b’, 111b’’, 111b’’’) and the middle section of the wires 111 are 35 mm, 35 mm, and 35 mm, respectively. An exemplary process of fabricating the proximal support member 110 has been explained later.
[0044] According to an embodiment, the proximal sealing member is disposed within the proximal support member 110. The proximal sealing member provides sealing and prevents blood from flowing from across the PFO. The proximal sealing member may have a pre-defined shape, such as, without limitation, cylindrical, disc, ring, rectangular, oval, etc. In an example implementation, the proximal sealing member is shaped in the form of a disc. In an embodiment, the diameter of the proximal sealing member may range between 1.50 mm and 3 mm, and the thickness of the proximal sealing member may range between 70 microns and 250 microns. In an example implementation, the diameter and the thickness of the proximal sealing member are 1.80 mm and 100 microns, respectively. In an embodiment, the proximal sealing member is a non-woven fabric made of a biocompatible material, such as, without limitation, HDPE (High-Density Polyethylene), PES (Polyester), PET (Polyethylene Terephthalate), etc. In an example implementation, the proximal sealing member is made of PET fabric. The non-woven fabric of the proximal sealing member fastens the process of new tissue growth covering the occluder device 100. The non-woven fabric provides a gap-free proximal sealing member, ensuring better coverage and uniformity. The proximal sealing member is coupled to the proximal support member 110, using a suitable technique such as, suturing, adhesive bonding, __, etc. In an embodiment, the proximal sealing member is sutured to the proximal support member 110 via suturing. Though the occluder device 100 has been explained herein with the proximal sealing member, it should be understood that the proximal sealing member is optional. Accordingly, the occluder device 100 may be without the proximal sealing member without deviating from the scope of the present disclosure.
[0045] The distal support member 120 is disposed at a pre-defined distance from the proximal support member 110. The distal support member 120 is disposed towards the distal end 100b of the occluder device 100 at a pre-defined distance from the proximal support member 110. The pre-defined distance may be chosen based upon the patient’s anatomy and procedural requirements. The distal support member 120 is laser-cut. The distal support member 120 is provided to give structural stability to the occluder device 100 such that the occluder device 100 remains in position. The distal support member 120 may be made of a material, including, without limitation, nitinol, Ni-Ti-Cu, Ni-Ti-Pd, Cu-Al-Ni, etc. or any other biocompatible, shape-memory (self-expanding) material. In an example implementation, the distal support member 120 is made of nitinol. In an embodiment, the distal support member 120 is made from a single tube using a laser cutting technique. Since the distal support member 120 is laser-cut, the distal support member 120 has more strength than the proximal support member 110. Consequently, the distal support member 120 enhances stability and durability, gives better anchoring, ensures secure placement during the deployment of the occluder device 100 and prevents the migration of the occluder device 100 after implantation. An exemplary process to fabricate the distal support member 120 is explained later. Figs. 4a and Fig. 4b depict various perspective views of an exemplary distal support member 120, according to an embodiment. The distal support member 120 has a proximal end 120a and a distal end 120b. In an embodiment, the distal support member 120 includes a plurality of U-shaped struts 121 (hereinafter, the struts 121), a proximal tubular section 123, and a distal tubular section 125.
[0046] The proximal tubular section 123 is disposed at the proximal end 120a and the distal tubular section 125 is disposed at the distal end 120b. The proximal tubular section 123 and the distal tubular section 125 are axially aligned and have a pre-defined distance therebetween. The pre-defined distance between the proximal tubular section 123 and the distal tubular section 125 may be chosen based upon the patient’s needs. In an embodiment, the pre-defined distance may range between 3 mm and 10 mm. In an example implementation, the pre-defined distance is 5 mm. In an embodiment, the proximal tubular section 123 and the distal tubular section 125 have a cylindrical shape, defining a respective central opening (not shown). In an embodiment, the proximal tubular section 123 and the distal tubular section 125 have the same diameter designed based upon the patient’s requirements. The diameter of the proximal and the distal tubular sections 123, 125 may range between 1.5 mm and 5 mm. In an example implementation, the diameter of the proximal and the distal tubular section 123, 125 is 1.8 mm. The proximal and the distal tubular sections 123, 125 may have the same or different lengths. In an embodiment, the proximal and distal tubular sections 123, 125 have the same length ranging between 3 mm and 10 mm. In an example implementation, the length of the proximal and distal tubular sections 123, 125 is 5 mm.
[0047] The struts 121 are arranged radially between the proximal tubular section 123 and the distal tubular section 125. The number of struts 121 may be chosen based upon requirements. In an embodiment, the distal support member 120 includes at least 8 struts 121. Preferably, the distal support member 120 includes between 8 and 40 struts 121. More preferably, the distal support member 120 includes between 8 and 32 struts 121. In the depicted embodiment, the distal support member 120 includes sixteen struts 121. It should be appreciated though that the distal support member 120 may include less than or more than sixteen struts 121. It is to be noted that only a few of the struts 121 are marked in Figs. 4a – 4b for reasons of clarity. Each strut 121 includes a first arm 121a provided towards the proximal end 120a, a second arm 121b disposed towards the distal end 120b and a connecting portion 121c disposed between the first arm 121a and the second arm 121b, and coupling the first arm 121a and the second arm 121b. Fig. 4c illustrates the distal support member 120 showing two of the struts 121, according to an embodiment. A first end 121d of the first arm 121a of the strut 121 is integrally coupled to the proximal tubular section 123 and a second end 121e of the second arm 121b of the strut 121 is integrally coupled to the distal tubular section 125. According to an embodiment, the first end 121d and the second end 121e of each strut 121 are coupled to the proximal tubular section 123 and the distal tubular section 125, respectively, such that the first end 121d and the second end 121e are angularly offset by a pre-defined angle P as shown in Fig. 4d. The angular offset between the first end 121d and the second end 121e minimizes the chances of the blood flow through the distal support member 120 and facilitates better closure of the PFO. The pre-defined angle P may range between 10 degrees and 25 degrees, more preferably, between 10 degrees and 15 degrees. In an example implementation, the pre-defined angle P is 10.15 degrees. In another embodiment, the first end 121d and the second end 121e have no angular offset.
[0048] The first arms 121a of the struts 121 may be co-planar or may be slanted towards the proximal end 120a. Similarly, the second arms 121b of the struts 121 may be co-planar or slanted towards the distal end 120b. In an embodiment, the first arms 121a of the struts 121 are co-planar and the second arms 121b of the struts 121 are co-planar, thus forming a disc shape as depicted in Fig. 4b. The disc-shaped arrangement of the struts 121 (i.e., the first arms 121a being co-planar and the second arms 121b being co-planar) provides a uniform and low-profile coverage at the septal wall, thereby conforming more closely to the underlying tissue. Further, such a design helps in distributing stresses evenly, enhancing the sealing efficiency, and reducing the risk of complications as opposed to when the first arms 121a and/or the second arms 121b are non-planar or slanted. The first arms 121a and the second arms 121b may have the same or different widths. In an embodiment, the first arms 121a and the second arms 121b have the same width ranging between 2 mm and 8 mm. In an example implementation, the first arms 121a and the second arms 121b have the width of 2.5 mm. Each first arm 121a or second arm 121b may have a uniform or non-uniform width along their respective lengths. In an embodiment, each first arm 121a or second arm 121b has uniform width throughout their respective lengths. The uniform width of each first arm 121a and second arm 121b ensures even stress distribution and reduces the risks of breakage.
[0049] The connecting portion 121c generally has a U-shape. In an embodiment, the connecting portion 121c includes a single curved segment. In another embodiment, the connecting portion 121c may have more than one segments having a pre-defined shape, such as, serpentine, zig-zag, sinusoidal, etc. The width of the connecting portion 121c may be equal to, smaller or greater than the width of the first and second arms 121a, 121b. In an embodiment, the width of the connecting portion 121c is equal to the width of the first and second arms 121a, 121b, allowing for easy manufacturing. The width of the connecting portion 121c may range between 2 mm and 8 mm. In an example implementation, the width of the connecting portion 121c is 2.5 mm.
[0050] In an embodiment, the first arm 121a and the second arm 121b of the strut 121 are identical. Therefore, for reasons of brevity, the struts 121 are further described with the help of the first arms 121a. The structure of the second arms 121b may be referred from that of the first arms 121a and is not repeated for the sake of brevity. It should be understood though that in various embodiment, the first arm 121a and the second arm 121b of the strut 121 may not be identical.
[0051] The first arms 121a of adjacent struts 121 may be designed (e.g., the first arms 121a of the adjacent struts 121 are mirror images of each other) such that the distal support member 120 is radially symmetrical. The first arms 121a may be straight or curved. In an embodiment, one or more of the first arm 121a are curved and have at least one curved segment. The first arms 121a with at least one curved segment provides better strength to the distal support member 120, distributes stress more evenly and avoids weak points caused by sharp angles as compared to the first arms 121a without any curved segments. Curvatures of the at least one curved segment of the first arm 121a may be designed to form a smooth profile and avoid any discontinuities in the radii of the curvatures. This prevents build-up of stress at such discontinuities, thereby imparting greater strength to the distal support member 120, minimizing chances of its breakage and increasing its life.
[0052] In an embodiment, at least one pair of adjacent first arms 121a are coupled using one or more first links 127 integrally coupled to the first arm 121a. Alternately or in addition, at least one pair of adjacent second arms 121b are coupled using one or more second links. The second links are similar to the first links 127. Therefore, for reasons of brevity, only the first links 127 are described in detail, which mutatis mutandis is applicable to the second links. The one or more first links 127 impart additional strength and stability to the distal support member 120. According to an embodiment, the one or more first links 127 are curved and may have a pre-defined shape, such as, without limitation, S-shaped, C-shaped, U-shaped, curved M-shaped, curved N-shaped, curved W-shaped, O-shaped, oval shaped, serpentine, sinusoidal, etc. or any other curved profile without discontinuities in curvatures or vertices. The curved profile without any discontinuities eliminates stress at such discontinuities and improves stability of the one or more first links 127, and thereby of the distal support member 120. Though the present disclosure has been explained with the one or more first links 127 having curved profiles, it should be understood that the one or more first links 127 may have other shapes, such as, a single straight segment, a shape having multiple straight segments (e.g., V-shaped, M-shaped, W-shaped, N-shaped, zig-zag, etc.) or a combination of straight and curved segments, without deviating from the scope of the present disclosure. The one or more first links 127 may have the same shape or may have different shapes. The one or more first links 127 may have the same or different width. Further, the width of the one or more first links 127 may be the same, smaller, or larger than the width of the first arms 121a that the one or more first links 127 are coupled to. In an embodiment, the one or more first links 127 have the same width as that of the first arms 121a.
[0053] The first arms 121a are designed to form a pre-defined pattern. Fig. 4e illustrates a rear view of the distal support member 120 showing an exemplary pre-defined pattern of the first arms 121a of the struts 121, according to an embodiment. It should be noted that the second arms 121b may be designed in an identical pre-defined pattern. In an exemplary embodiment, each first arm 121a includes two curved segments, namely, a first curved segment 122a and a second curved segment 122b. The first curved segment 122a is disposed towards the center of the proximal tubular section 123 and is coupled to the proximal tubular section 123 and the second curved segment 122b is disposed radially away from the center of the proximal tubular section 123 and is coupled to the connecting portion 121c. Similarly, a first curved segment (not shown) and a second curved segment (not shown) of the second arm 121b is coupled to the distal tubular section 125 and the connecting portion 121c, respectively. In the depicted embodiment, the first curved segment 122a has a concave profile and the second curved segment 122b has a convex profile. The lengths and curvatures of the first curved segment 122a and the second curved segment 122b may be designed to form a petal and leaf-like shapes as depicted in Fig. 4e.
[0054] In an embodiment, each alternate pair of adjacent first arms 121a is coupled using one first link 127. As shown in Fig. 4e, the first links 127 have an elongated S-shape, though the first links 127 may have any other shape. The first links 127 may be coupled to the first arms 121a at any desired position. Fig. 4f illustrates the coupling between a pair of adjacent first arms 121a using one first link 127 according to an embodiment. A first end 127a of the first link 127 is coupled with the first curved segment 122a of the first arm 121a’ of the pair of adjacent first arms 121a and a second end 127b of the first link 127 is coupled with the second curved segment 122b of the first arm 121a’’ of the pair of adjacent first arms 121a. According to an embodiment the first end 127a of the first link 127 is coupled to the first curved segment 122a and makes a first pre-defined angle X. Similarly, the second end 127b of the first link 127 is coupled to the second curved segment 122b and makes a second pre-defined angle Y. This minimizes stress build-up at these intersections and enhances strength and reliability. The first pre-defined angle X may range between 20 degrees and 70 degrees, and the second pre-defined angle Y may range between 90 degrees and 170 degrees.
[0055] It should be appreciated that the design of the first arms 121a shown in Figs. 4a – 4f is merely illustrative and should not be considered as limiting. The present disclosure can be extended to other designs without deviating from the scope of the present disclosure.
[0056] The distal sealing member 130 is disposed within the space enclosed by the struts 121. The distal sealing member 130 provides sealing and prevents blood from flowing from across the PFO. In an embodiment, the distal sealing member 130 may include non-woven fabric made of a biocompatible material, including, without limitation HDPE (High-Density Polyethylene), PES (Polyester), PET (Polyethylene Terephthalate), etc. In an example implementation, the distal sealing member 130 is made of PET fabric. The non-woven fabric of the distal sealing member 130 fastens the process of new tissue growth covering the occluder device 100, thus, reducing the time required for the PFO closure. The distal sealing member 130 is coupled to the distal support member 120. In an embodiment, the distal sealing member 130 is sutured to the distal support member 120. For example, the distal sealing member 130 is sutured with the connecting portions 121c of the struts 121 at a circumference of the distal sealing member 130 using a plurality of sutures 131 in a desired technique, e.g., 1:1, 1:2. The sutures 131 may be made of a suitable material, for example, polyester. The sutures 131 help in securely attaching the distal sealing member 130 with the distal support member 120, and prevents dislocation of the distal sealing member 130.
[0057] Fig. 5a and Fig. 5b depict the proximal jacket 140 according to an embodiment. The proximal jacket 140 is disposed at the proximal end 100a of the occluder device 100. The proximal jacket 140 is coupled to the proximal support member 110. The proximal jacket 140 is used to couple the occluder device 100 with a delivery system and helps in deploying and/or retrieving the occluder device 100. The proximal jacket 140 may be made of a biocompatible material, including, without limitation, stainless steel (e.g., SS316L), Co-Cr Alloy, Tantalum etc. In an example implementation, the proximal jacket 140 is made of stainless steel (e.g., SS316L). The proximal jacket 140 has a proximal end 140a and a distal end 140b. The proximal jacket 140 includes a first portion 141 provided at the proximal end 140a and a second portion 142 provided at the distal end 140b. In an embodiment, the first portion 141 has a tubular structure and includes a first cavity 141a extending for at least a partial length of the first portion 141. The first cavity 141a is cylindrical and may have a uniform diameter. The first cavity 141a may be smooth, partially threaded or fully threaded. In an embodiment, the first cavity 141a extends for the entire length of the first portion 141 and includes inner threads 141b. The inner threads 141b are coupled with the delivery system and enable the medical practitioner to engage or release the occluder device 100. The proximal jacket 140 may have a pre-defined number of inner threads 141b ranging between 2 and 10. In an embodiment, the proximal jacket 140 includes five inner threads 141b provided in the first cavity 141a. The first portion 141 may be generally cylindrical, though it may have any other shape. In an embodiment, the first portion 141 has a tapered shape such that an outer diameter of the first portion 141 decreases from a distal end to a proximal end of the first portion 141.
[0058] In an embodiment, the second portion 142 has a tubular structure and includes a second cavity 142a extending for at least a partial length of the second portion 142. The second cavity 142a is cylindrical and may have a uniform diameter. The second cavity 142a may be smooth. In an embodiment, the second cavity 142a extends for the entire length of the second portion 142 such that the second cavity 142a meets the first cavity 141a. The diameter of the second cavity 142a may be equal to, larger than or smaller than the first cavity 141a. In an embodiment, the diameter of the second cavity 142a is larger than the first cavity 141a. The second cavity 142a is axially aligned with the first cavity 141a. The second cavity 142a is configured to receive the proximal projection 110c of the proximal support member 110. The diameter of the second cavity 142a corresponds to the diameter of the proximal projection 110c. The proximal jacket 140 may be fixedly coupled to the proximal support member 110 using a suitable technique, for example without limitation, welding, adhesive bonding, crimping etc. In an embodiment, the proximal projection 110c of the proximal support member 110 is fixedly coupled, e.g., welded, to the inner surface of the second cavity 142a. For example, the first ends of the wires 111 may be welded with each other and with the inner surface of the second cavity 142a. The proximal jacket 140, specifically, the second portion 142 of the proximal jacket 140 helps in holding the first ends of the wires 111 together and maintain their position, thereby increasing longevity of the occluder device 100. The second portion 142 may be generally cylindrical, though it may have any other shape. In an embodiment, the second portion 142 has a uniform diameter along the entire length of the section portion 142. In another embodiment, the second portion 142 may have a tapered shape such that an outer diameter of the second portion 142 decreases from a proximal end to a distal end of the second portion 142.
[0059] The middle jacket 150 is disposed between the proximal support member 110 and the distal support member 120. The middle jacket 150 is coupled to the proximal support member 110 and the distal support member 120. Fig. 6 depicts the middle jacket 150, according to an embodiment. The middle jacket 150 may be made of a biocompatible material including, without limitation stainless steel (e.g., SS316L), Co-Cr Alloy, Tantalum etc. In an exemplary embodiment, the middle jacket 150 is made of SS316L. In an embodiment, the middle jacket 150 is cylindrical having a uniform diameter for the entire length of the middle jacket 150. The diameter of the middle jacket 150 may range between 1.50 mm and 4 mm. The length of the middle jacket 150 may be chosen based upon the thickness of the septum wall of the patient or the patient population in consideration. In an embodiment, the length of the middle jacket 150 may range between 1.20 mm and 7 mm. In an example implementation, the diameter and the length of the middle jacket 150 are 1.80 mm and 2 mm, respectively. The middle jacket 150 has a proximal end 150a and a distal end 150b. The middle jacket 150 includes a cavity 151 extending from the proximal end 150a for at least a partial length of the middle jacket 150. The cavity 151 may be a through-cavity or a blind cavity. In an exemplary embodiment, the cavity 151 is a blind cavity extending for a partial length of the middle jacket 150 and having a distal face 152. The cavity 151 may be cylindrical having a uniform diameter for the length of the cavity 151. The cavity 151 is configured to receive the distal projection 110d of the proximal support member 110. The middle jacket 150 may be fixedly coupled to the proximal support member 110 using, for example without limitation, welding, adhesive bonding, suturing, crimping etc. In an embodiment, the distal projection 110d of the proximal support member 110 is fixedly coupled, e.g., welded, to the inner surface of the cavity 151. For example, the second ends of the wires 111 are welded with each other and with the inner surface of the cavity 151. The diameter of the cavity 151 corresponds to the diameter of the distal projection 110d of the proximal support member 110. The middle jacket 150helps in holding the second ends of the wires 111 together and maintain their position, thereby increasing longevity of the occluder device 100.
[0060] The middle jacket 150 may be fixedly coupled to the distal support member 120 using, for example, welding. In an embodiment, the middle jacket 150 is at least partially disposed within, and coupled with, the proximal tubular section 123 of the distal support member 120. For example, the portion of the middle jacket 150 inside the proximal tubular section 123, is welded to an inner surface of the proximal tubular section 123. The welding ensures a robust and reliable bond between the middle jacket 150 and the proximal tubular section 123. The diameter of the middle jacket 150 correspond to the inner diameter of the proximal tubular section 123. The middle jacket 150 holds the proximal support member 110 and the distal support member 120 in position so that the proximal support member 110 and the distal support member 120 do not migrate from the target site.
[0061] Fig. 7 depicts the distal jacket 160, according to an embodiment. The distal jacket 160 is disposed at the distal end 100b of the occluder device 100. The distal jacket 160 may be made of a biocompatible material including, without limitation, stainless steel (e.g., SS316L), Co-Cr Alloy, Tantalum etc. In an exemplary embodiment, the distal jacket 160 is made of SS316L. The distal jacket 160 may have cross-sectional shape, including, without limitation, circle, square, oval. In an exemplary embodiment, the distal jacket 160 is cylindrical having a circular cross-section. In an embodiment, the distal jacket 160 is cylindrical having a uniform diameter for the entire length of the distal jacket 160. The diameter of the distal jacket 160 may range between 1.50 mm and 4 mm. The length of the distal jacket 160 may range between 1.2 mm and 6 mm. In an example implementation, the diameter and the length of the distal jacket 160 are 2 mm and 2.5 mm, respectively. The distal jacket 160 has a proximal end 160a and a distal end 160b. The distal jacket 160 includes a cavity 161 extending from the proximal end 160a at least partially for the length of the distal jacket 160. The cavity 161 may be a through cavity or a blind cavity. In an embodiment, the cavity 161 is a blind cavity extending for a partial length of the distal jacket 160 and having a distal face 162. The cavity 161 is configured to receive a portion of the distal tubular section 125 of the distal support member 120. The diameter of the cavity 161 corresponds to the outer diameter of the distal tubular section 125. The distal jacket 160 may be fixedly coupled to the distal support member 120 using, for example, welding. In an embodiment, the portion of the distal tubular section 125 within the cavity 161, is welded to the inner surface of the cavity 161. The distal face 162 serves as a smooth protective barrier over the sharp edges of the distal support member 120, preventing tissue damage and ensuring patient safety. It is to be noted, other embodiments of the distal jacket 160 without the distal face 162 are possible. In such cases, the sharp edges of the distal support member 120 may be smoothed or covered.
[0062] Fig. 8 depicts a flowchart of an exemplary method 900 of fabricating the occluder device 100, according to an embodiment. At step 901, the proximal support member 110 is fabricated using a braiding technique. An embodiment of fabricating the proximal support member 110 is explained with respect to Fig. 9.
[0063] At step 903, the distal support member 120 is fabricated from a single tube using a laser cutting technique. An embodiment of fabricating the distal support member 120 is explained with respect to Fig. 10.
[0064] At step 905, the proximal jacket 140 is coupled to the proximal support member 110. For example, the proximal protrusion of the proximal support member 110 is inserted into the second cavity 142a of the proximal jacket 140 and welded to the inner surface of the second cavity 142a using any process known in the art, such as, arc welding, spot welding, laser welding, etc.
[0065] At step 907, the middle jacket 150 is coupled to the proximal support member 110. For example, the distal protrusion of the proximal support member 110 is inserted into the cavity 151 of the middle jackets 150 and welded to the inner surface of the middle jacket 150 using any process known in the art, such as, arc welding, spot welding, laser welding etc.
[0066] At step 909, the middle jacket 150 is coupled to the distal support member 120. For example, a portion of the middle jacket 150 is inserted into and welded to the proximal tubular section 123 of the distal support member 120.
[0067] At step 911, the proximal sealing member is inserted into the proximal support member 110. The proximal sealing member is adjusted according to the shape and size of the proximal support member 110 to maintain consistent tension and minimize potential gaps or weak points. Thereafter, the proximal sealing member is sutured with the proximal support member 110.
[0068] At step 913, the distal sealing member 130 is inserted into the distal support member 120 and sutured with the connecting portions 121c of the struts 121 of the distal support member 120 using the sutures 131. The proximal sealing member and the distal sealing member 130 may be fabricated using any known technique in the art.
[0069] At step 915, the distal jacket 160 is coupled to the distal support member 120. For example, a portion of the distal tubular section 125 of the distal support member 120 is inserted into the cavity 161 of the distal jacket 160, and welded to the inner surface of the cavity 161.
[0070] Fig. 9 depicts an exemplary method 1000 for fabricating the proximal support member 110 using a braiding technique. At step 1001, a wire 111 of a desired material, e.g., nitinol, is arranged in a 1:1 braiding pattern. A pre-defined number of, e.g., 48, 72 or 128, wires 111 are used based upon requirements
[0071] At step 1003, a mandrel is selected for braiding. In an example, a stainless-steel rod is chosen as the mandrel. The diameter of the mandrel is chosen based upon the final dimensions of the proximal support member 110.
[0072] At step 1005, the wires 111 are braided on the mandrel in a pre-defined pattern, for example, a helical pattern as depicted in Figs. 3b – 3c, using an automatic braiding machine to form a braided structure.
[0073] At step 1007, the mandrel having the braided structure on it, is subjected to heat treatment. The temperature and duration of the heat treatment may vary based upon the diameter of the wires 111 and the size of the braided structure. For example, braided structure of smaller dimensions with thinner wires 111 typically require lower temperatures and moderate heating durations. Conversely, the braided structure of greater dimensions with thicker wires 111 requires higher temperatures and longer heat treatment times to achieve the required shape and structural integrity. For example, the mandrel is placed in a heat treatment machine and heated to a temperature between 400 degrees and 600 degrees for 5 to 10 minutes. In an exemplary embodiment, the mandrel is heated to 505 degrees for 10 minutes.
[0074] At step 1009, the mandrel having the braided structure on it, is cooled in a chiller. This step cools the braided wires. The mandrel may be cooled to 20 - 30 degrees. In an exemplary embodiment, the mandrel is cooled to 25 degrees.
[0075] At step 1011, the braided structure is removed from the mandrel.
[0076] At step 1013, the braided structure is subjected to a shape-setting process as per the pre-defined pattern of the proximal support member 110. This step helps to set the shape of the proximal support member 110. In an embodiment, the braided portion is placed in a mold (not shown). The mold includes one or more grooves corresponding to the pre-defined pattern of the proximal support member 110. The braided portion is disposed inside the one or more grooves. The mold having the braided portion, is then subjected to a heat treatment. In an embodiment, the mold is heated to a temperature between 400 degrees and 600 degrees for a duration of 5 to 10 minutes. In an exemplary embodiment, the mold is heated to 505 degrees for 6 minutes. The mold is then placed in a chiller to cool the mold to a temperature between 20 and 30 degrees, thereby forming the proximal support member 110. In an embodiment, the mold is cooled to 25 degrees. The proximal support member 110 is then removed from the mold.
[0077] At step 1015, the proximal sections (e.g., 111a’, 111a’’, 111a’’’) of the wires 111 are welded to form the proximal projection 110c and the distal sections (e.g., 111b’, 111b’’, 111b’’’) of the wires 111 are welded to form the distal projection 110d of the proximal support member 110.
[0078] Fig. 10 depicts a flowchart of an exemplary method 1100 of fabricating the distal support member 120 using a laser cutting technique. At step 1101, a tube of a pre-defined material is selected. In an embodiment, the tube is made of nitinol and has desired dimensions according to the distal support member 120.
[0079] At step 1103, the tube is cut according to a desired design with the help of a laser cutting machine to form a laser cut structure. The desired design corresponds to the pre-defined pattern of the distal support member 120 as described herein.
[0080] At step 1105, the laser cut structure is subjected to a de-burring process using a rotatory tool. The high rotational speed and fine abrasive attachments of the rotatory tool, ensures a smooth finish without causing damage to the laser cut structure. This step removes any burrs from the laser cut structure and makes the laser cut structure smooth.
[0081] At step 1107, the laser cut structure is subjected to a shape-setting process. This process is performed to achieve a desired shape of the distal support member 120. In an embodiment, the laser cut structure is placed in a mold. The mold includes one or more grooves correspond to the design of the U-shaped strut 121 of the distal support member 120 (e.g., as depicted in Fig. 4a). The mold containing the laser cut structure is subjected to a heat treatment using a heat treatment machine. In an embodiment, the mold containing the laser cut structure is placed in the heat treatment machine at a temperature ranging between 400 degrees and 600 degrees for 5-10 minutes. In an example implementation, the mold containing the laser cut structure is heated to 505 degrees for 3 minutes. The mold containing the laser cut structure is then cooled in a chiller and cooled to a temperature between 10 degrees and 30 degrees. In an example implementation, the mold containing the laser cut structure is cooled to 22 degrees. The distal support member 120 thus formed is removed from the mold.
[0082] The occluder device 100 is delivered and deployed at the target site using a delivery system. In an embodiment, the delivery system includes a delivery cable 10 (shown in Fig. 11a), a delivery sheath 20 (shown in Fig. 13a, 13b), a loader, a dilator and a guidewire. The loader is configured to radially collapse/crimp the proximal support member 110 and the distal support member 120 of the occluder device 100, and is used to load the occlude device 100 in the delivery sheath 20. The delivery sheath 20 has an elongated, tubular structure and provides a passage for various components of the delivery system, e.g., the occluder device 100, the loader, the delivery cable 10, the dilator, the guidewire, etc. during the deployment procedure. Figs. 11a – 11b depict an exemplary delivery cable 10 of the delivery system. The delivery cable 10 is used to guide the occluder device 100 through the delivery sheath 20 to the target site. The delivery cable 10 has a proximal end 10a and a distal end 10b. A hub 11 is coupled to the proximal end 10a of the delivery cable 10. The hub 11 is provided with a roller 13. The roller 13 helps in coupling the delivery cable 10 with the hub 11. The hub 11 is rotatable and is used to rotate the delivery cable 10. The delivery cable 10 includes a rod 15 extending between the proximal end 10a and the distal end 10b. The delivery cable 10 includes a coiled portion 15b provided on the rod 15 such that a distal end of the rod 15 protrudes out of the coiled portion 15b. The coiled portion 15b helps in navigating the delivery cable 10. The delivery cable 10 may be made of stainless steel or any other suitable material. Threads 15a are provided at the distal end of the rod 15. The threads 15a are configured to engage with the inner threads 141b of the proximal jacket 140. The number of threads 15a correspond to the number of inner threads 141b of the proximal jacket 140. The threads 15a are used to engage and/or disengage the occluder device 100 from the delivery cable 10.
[0083] Fig. 12 depicts a flowchart of an exemplary method 1300 for delivering the occluder device 100 using the delivery system. Various steps of the method 1300 may be performed under fluoroscopic guidance or any other imaging guidance technique. At step 1301, the occluder device 100 is loaded into the loader. In an embodiment, the delivery cable 10 is inserted into the loader. The occluder device 100 is securely attached with the delivery cable 10, for example, by engaging the inner threads 141b of the proximal jacket 140 with the threads 15a of delivery cable 10 and rotating the hub 11 the pre-defined number of times (e.g., five times) corresponding to pre-defined number of inner threads 141b in a first pre-defined direction (e.g., clockwise direction). Thereafter, the delivery cable 10 is retracted to load the occluder device 100 into the loader.
[0084] At step 1303, the delivery sheath 20 having the dilator is inserted into a patient’s vasculature at a desired entry point, e.g., femoral, and navigated through the patient’s vasculature to a target site. In an embodiment, the delivery sheath 20 advanced until the dilator passes through the PFO and is disposed withing the right atrium. The dilator is used to enlarge the target site to accommodate the occluder device 100. The delivery sheath 20 having the dilator may be advanced over the guidewire.
[0085] At step 1305, the dilator and the guidewire are removed from the delivery sheath 20.
[0086] At step 1307, the occluder device 100 is inserted into the delivery sheath 20. In an embodiment, the loader is inserted into the delivery sheath 20 to create a pathway for the occluder device 100. The delivery cable 10 is then advanced through the loader into the delivery sheath 20, allowing the occluder device 100 to enter the delivery sheath 20.
[0087] At step 1309, the occluder device 100 is advanced through the delivery sheath 20 using the delivery cable 10 until the occluder device 100 reaches the target site.
[0088] At step 1311, the occluder device 100 is deployed at the target site using the delivery cable 10. In an embodiment, the distal support member 120 is released into the right atrium of the heart by advancing the delivery cable 10 to push the distal support member 120 out of the delivery sheath 20. Without the constraining force of the delivery sheath 20, the distal support member 120 radially expands to attain the pre-set shape due to the shape-memory characteristics of the distal support member 120. Fig. 13a depicts a partial deployment stage of the occluder device 100 where the distal support member 120 is exposed from the delivery sheath 20. The delivery system is then retracted by a desired distance (e.g., 2-3 mm) to create tension in the delivery cable 10, positioning of the distal support member 120 correctly. At this stage, a proximal side of the disc-shaped distal support member 120 contacts the septum wall in the right atrium. The proximal support member 110 is then deployed the left atrium of the heart by retracting the delivery sheath 20. The delivery sheath 20 is retracted by a desired distance to expose the proximal support member 110 and the proximal jacket 140 in the right atrium (as shown in Fig. 13b). Without the constraining force of the delivery sheath 20 regains the pre-set shape due to the shape-memory characteristics of the proximal support member 110. At this stage, a distal side of the mesh 112 contacts the septum wall in the left atrium. The medical practitioner may adjust the position of the delivery cable 10 to ensure that the occluder device 100 is positioned correctly. Figs. 2a – 2b depict the occluder device 100 deployed at the target site.
[0089] At step 1313, the delivery system is detached from the occluder device 100 by rotating the hub 11 the pre-defined number of times (e.g., five times) in a second pre-defined direction (e.g., anti-clockwise direction) opposite to the first pre-defined direction.
[0090] At step 1315, the delivery system is withdrawn from the patient’s vasculature.
[0091] The proposed occluder device includes a braided proximal support member and a laser-cut distal support member. Such a hybrid-structure of the occluder device offers several advantages over conventional devices. The braided proximal support member provides flexibility and the laser-cut distal support member provides strength and allows for easier deployment. Consequently, the occluder device has enhanced flexibility and allows for precise delivery during the implantation procedure. The occludes device provides a more effective and adaptable closure of the patent foramen ovale, reducing the risk of cardiac arrest/stroke, thereby improving patient outcomes. The occluder device is easy to deploy thereby reducing procedural complexity and increasing patient comfort. The distal support member, which is laser-cut, gives better conformability, ensuring a snug-fit against the septal wall. As a result, the occluder device does not migrate from the target site, eliminating the risk of any unwanted motion and improving patient safety and long-term outcomes in PFO closure interventions. The occluder device is more comfortable for the patient as compared to other conventional devices. Further, the distal support member’s smoother surface minimizes areas where blood clots can form. Additionally, the distal support member promotes optimal blood flow around the occluder device, further decreasing thrombosis risk and preventing strokes. By effectively preventing strokes, the occluder device improves patient’s overall quality of life. Moreover, a more open structure of the distal support member as compared to a braided distal disc in a conventional device, encourages faster endothelialization (i.e., tissue growth), improving biocompatibility. By sealing the opening in the heart with the help of proximal support member and the distal support member, the occluder device prevents the blood clots from travelling to the brain. The occluder device also resolves challenges such as residual shunts, device migration, and procedural complexity as seen with conventional devices.
[0092] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM
1. An occluder device (100) configured to close an opening within a heart, the occluder device (100) comprising:
a. a proximal support member (110); and
b. a distal support member (120) coupled to the proximal support member (110), the distal support member (120) comprising:
i. a proximal tubular section (123);
ii. a distal tubular section (125); and
iii. a plurality of U-shaped struts (121) arranged radially between the proximal tubular section (123) and the distal tubular section (125), wherein each of the plurality of struts (121) comprise a first arm (121a) coupled to the proximal tubular section (123), a second arm (121b) coupled to the distal tubular section (125), and a connecting portion (121c) coupling the first arm (121a) and the second arm (121b);
c. wherein the proximal support member (110) is braided;
d. wherein the distal support member (120) is laser-cut from a single tube made of a biocompatible, self-expanding material.
2. The occluder device (100) as claimed in claim 1, wherein a first end (121d) of the first arm (121a) coupled to the proximal tubular section (123) and a second end (121e) of the second arm (121b) coupled to the distal tubular section (125) are angularly offset by a pre-defined angle (P).
3. The occluder device (100) as claimed in claim 2, wherein the pre-defined angle (P) ranges between 10 degrees and 25 degrees.
4. The occluder device (100) as claimed in claim 1, wherein at least one of:
a. the first arms (121a) of the plurality of struts (121) are co-planar; or
b. the second arms (121b) of the plurality of struts (121) are co-planar.
5. The occluder device (100) as claimed in claim 1, wherein each of the first arm (121a) and the second arm (121b) comprises at least one curved segment.
6. The occluder device (100) as claimed in claim 1, wherein each of the first arm (121a) and the second arm (121b) comprises a first curved segment (122a) coupled to one of the proximal tubular section (123) or the distal tubular section (125), and a second curved segment (122b) coupled to the connecting portion (121c).
7. The occluder device (100) as claimed in claim 6, wherein the first curved segment (122a) has a concave profile and the second curved segment (122b) has a convex profile.
8. The occluder device (100) as claimed in claim 1, wherein one or more of:
a. at least one pair of adjacent first arms (121a) are coupled using one or more first links (127), or
b. at least one pair of adjacent second arms (121b) are coupled using one or more second links.
9. The occluder device (100) as claimed in claim 8, wherein at least one of:
a. each of the first links (127) is curved, or
b. each of the second links is curved.
10. The occluder device (100) as claim in claim 8, wherein each alternate pair of adjacent first arms (121a) is coupled using one first link (127), and each alternate pair of adjacent second arms (121b) is coupled using one second link.
11. The occluder device (100) as claimed in claim 1, wherein the occluder device (100) comprises a distal jacket (160) provided at a distal end (100b) of the occluder device (100) and coupled to the distal tubular section (125) of the distal support member (120).
12. The occluder device (100) as claimed in claim 11, wherein the distal jacket (160) comprises a cavity (161) configured to receive and coupled with at least a portion of the distal tubular section (125).
13. The occluder device (100) as claimed in claim 1, wherein the occluder device (100) comprises a middle jacket (150) disposed between and coupled to the proximal support member (110) and the distal support member (120).
14. The occluder device (100) as claimed in claim 13, wherein the middle jacket (150) comprises a cavity (151) configured to receive and coupled with a distal projection (110d) of the proximal support member (110)
15. The occluder device (100) as claimed in claim 13, wherein at least a portion of the middle jacket (150) is disposed in and coupled with the proximal tubular section (123) of the distal support member (120).
16. The occluder device (100) as claimed in claim 1, wherein the occluder device (100) comprises a proximal jacket (140) provided at a proximal end (100a) of the occluder device (100) and comprising:
a. a first portion (141) provided at a proximal end (140a) of the proximal jacket (140) and coupled to a delivery system configured to deliver the occluder device (100); and
b. a second portion (142) provided at a distal end (140b) of the proximal jacket (140) and coupled to the proximal support member (110).
17. The occluder device (100) as claimed in claim 16, wherein the first portion (141) comprises a first cavity (141a) having inner threads (141b) configured to couple with corresponding threads (15a) of the delivery system.
18. The occluder device (100) as claimed in claim 16, wherein the second portion (142) comprises a second cavity (142a) configured to receive and coupled with a proximal projection (110c) of the proximal support member (110).
19. The occluder device (100) as claimed in claim 1, wherein the proximal support member (110) comprises a plurality of wires (111) braided together to form the proximal support member (110).
20. The occluder device (100) as claimed in claim 19, wherein each wire (111) comprises a proximal section (111a’, 111a’’, 111a’’’), a distal section (111b’, 111b’’, 111b’’’) and a middle section (111c’, 111c’’, 111c’’’) disposed between the proximal section (111a’, 111a’’, 111a’’’) and the distal section (111b’, 111b’’, 111b’’’); wherein the proximal sections (111a’, 111a’’, 111a’’’) are coupled with each other to form a proximal projection (110c) of the proximal support member (110); wherein the distal sections (111b’, 111b’’, 111b’’’) are coupled with each other to form a distal projection (110d) of the proximal support member (110); and wherein the middle sections (111c’, 111c’’, 111c’’’) are braided to form a mesh (112).
21. The occluder device (100) as claimed in claim 1, wherein the occluder device (100) comprises a proximal sealing member disposed within and coupled to the proximal support member (110).
22. The occluder device (100) as claimed in claim 1, wherein the occluder device (100) comprises a distal sealing member (130) disposed within a space enclosed by the plurality of struts (121) and coupled to the connecting portions (121c) of the plurality of struts (121).