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 IMPLANT AND DELIVERY SYSTEM THEREFOR
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 invention relates to an occluder implant. More specifically, the present invention relates to a septal patch occluder implant and a system to deliver the occluder implant.
BACKGROUND OF INVENTION
[002] A septal defect is a congenital heart defect defined by a hole in the atrial septum, the wall between the chambers of the heart. This defect increases the amount of blood flowing through the lungs and may lead to complications if left untreated. Septal defect is most commonly observed in pediatric patients and can cause symptoms such as shortness of breath and physical limitations, including difficulty in performing strenuous activities. Left untreated, these symptoms can lead to severe complications. While small septal defect may be discovered incidentally and may close spontaneously during infancy or early childhood, larger defects can result in significant heart and lung damage over time.
[003] Conventionally, interventional occlusion systems use a self-expanding umbrella-like structure delivered transvenously into the septal defect. These systems have two umbrella-like components, one on the distal side and another on the proximal side of the septum with a peg connecting them through the defect. The interlocking umbrellas form a double umbrella structure, sealing the defect. However, conventional occlusion devices present several challenges, including complex implantation procedures and material limitations. The implantation process is intricate and difficult to execute precisely. Additionally, the umbrella components are prone to material fatigue, fragmentation, and thromboembolic complications, further limiting their effectiveness and long-term reliability.
[004] Various conventionally used occlusion devices, including metal and biodegradable occluders, have been employed for the closure of septal defect. However, these devices present several limitations that affect both immediate and long-term patient outcomes. One of the primary concerns associated with metal occluders is the high metal content within the body. Metal implants can interfere with future medical imaging, such as MRI and CT scans, potentially limiting diagnostic and therapeutic options for patients requiring further cardiac interventions. Additionally, the presence of metal within the bloodstream raises concerns regarding metal ion leaching, which can lead to systemic complications. In some cases, metal leaching has been associated with hematuria, a condition characterized by the presence of blood in the urine, which may indicate renal impairment or an adverse immune response to the implanted device.
[005] Another drawback of conventional occlusion implants is their impact on future treatment accessibility. Once a metal occluder is implanted, performing subsequent interventions such as transcatheter valve replacements or surgical revisions becomes more complex due to the rigid and permanent nature of the implant. The presence of a metallic occluder may also complicate the closure of residual defects or adjustments required due to physiological changes over time, especially in pediatric patients who continue to grow after the device has been implanted.
[006] Biodegradable occluders have been introduced to address some of these concerns, however, they too have various limitations. While these devices are designed to degrade over time, the degradation process can be unpredictable, leading to potential issues such as incomplete occlusion, embolization of degraded fragments, or localized inflammatory responses. Moreover, the structural integrity of biodegradable occluders during the initial implantation phase remains a concern, as premature degradation or weakening of the device may compromise its ability to maintain effective defect closure.
[007] Traditional delivery systems for septal occluders accommodate a wide range of device sizes, necessitating multiple catheters covering a wide range of sizes. This variation in catheter sizes can complicate the selection process for physicians, leading to potential inefficiencies in implantation and increasing the risk of procedural errors. Additionally, the requirement for multiple catheters demands a larger inventory, making logistics and storage more complex for healthcare providers.
[008] Therefore, there is a need for an improved implant and an associated delivery system that overcomes the challenges above.
SUMMARY OF INVENTION
[009] The present disclosure relates to an implant to occlude a septal defect. In an embodiment, the implant includes a sealing member and a plurality of anchors. The sealing member includes a first portion having a first thickness and a second portion surrounding the first portion and having a second thickness greater than the first thickness of the first portion. The plurality of anchors extends from a distal face of the second portion to a distal end of the implant and is configured to penetrate through a septum wall. A portion of each anchor of the plurality of anchors is configured to reside in the septum wall. The first portion and the second portion of the sealing member are made of a self-healing, biocompatible material.
[0010] The present invention further discloses a delivery system for delivering an implant. The delivery system includes an outer shaft, an inner shaft disposed within the outer shaft, a gripping assembly and a control element. The gripping assembly includes a plurality of gripping members coupled to the inner shaft and configured to grip an implant. The control element is coupled to the inner shaft. The control element is configured to axially move the inner shaft and trigger the gripping assembly to be in one of: an undeployed state, a partially deployed state or a fully deployed state. In the undeployed state, the plurality of gripping members is completely disposed inside the outer shaft. In the partially deployed state, the plurality of gripping members is partially disposed inside the outer shaft and partially disposed outside the outer shaft. In the deployed state, the plurality of gripping members is completely disposed outside the outer shaft to release the implant.
[0011] The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF DRAWINGS
[0012] 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 instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[0013] Fig. 1A depicts a perspective view of an implant 100, in accordance with an embodiment of the present invention.
[0014] Fig. 1B depicts a cross-sectional view of the implant 100, in accordance with an embodiment of the present invention.
[0015] Fig. 1C depicts a perspective view of an anchor 104 of the implant 100, in accordance with an embodiment of the present invention.
[0016] Fig. 1D depicts a cross-sectional view of an anchor 104 of the implant 100, in accordance with an embodiment of the present invention.
[0017] Fig. 2A depicts a perspective view of a delivery system 200, in accordance with an embodiment of the present invention.
[0018] Fig. 2B depicts an exploded view of the delivery system 200, in accordance with an embodiment of the present invention.
[0019] Fig. 3 depicts a perspective view of an outer shaft 500, in accordance with an embodiment of the present invention.
[0020] Fig. 4 depicts a perspective view of an inner shaft 400, in accordance with an embodiment of the present invention.
[0021] Fig. 5A depicts a perspective view of a gripping assembly 300, in accordance with an embodiment of the present invention.
[0022] Fig. 5B depicts a perspective view of a gripping assembly 300 in a partially expanded state, in accordance with an embodiment of the present invention.
[0023] Fig. 5C depicts a perspective view of a gripping assembly 300 in a fully expanded state, in accordance with an embodiment of the present invention.
[0024] Fig. 6 depicts a perspective view of a control element 450, in accordance with an embodiment of the present invention.
[0025] Fig. 7A depicts a perspective view of a handle 600, in accordance with an embodiment of the present invention.
[0026] Fig. 7B depicts a cross-sectional view of the handle 600, in accordance with an embodiment of the present invention.
[0027] Fig. 8 depicts a flowchart of a method 800 for deployment of the implant 100 using delivery system 200, in accordance with an embodiment of the present invention.
[0028] Fig. 9A depicts a perspective view of the handle 600 in an undeployed state, in accordance with an embodiment of the present invention.
[0029] Fig. 9B depicts a cross-sectional view of the gripping assembly 300 and the implant 100 in the undeployed state, in accordance with an embodiment of the present invention.
[0030] Fig. 10A depicts a perspective view of the handle 600 in a partially deployed state, in accordance with an embodiment of the present invention.
[0031] Fig. 10B depicts a cross-sectional view of the gripping assembly 300 and the implant 100 in the partially deployed state, in accordance with an embodiment of the present invention.
[0032] Fig. 10C depicts a cross-sectional view of the gripping assembly 300 and the implant 100 at penetration state in a septum 10, in accordance with an embodiment of the present invention.
[0033] Fig. 11A depicts a perspective view of the handle 600 in a fully deployed state, in accordance with an embodiment of the present invention.
[0034] Fig. 11B depicts a cross-sectional view of the gripping assembly 300 and the implant 100 in the fully deployed state, in accordance with an embodiment of the present invention.
[0035] Fig. 12A and Fig. 12B depict a perspective view of the delivery system 200 and the implant 100 after deployment, in accordance with an embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0036] 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.
[0037] 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.
[0038] 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.
[0039] 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.
[0040] The present disclosure relates to a septal occluder implant (hereinafter, implant). The implant is used for closing a septal defect, such as an atrial septal defect (ASD) or a ventricular septal defect (VSD). The implant is made of a self-healing material, such as medical-grade silicone, which enables it to seal the defect immediately upon deployment and accommodate future treatment accessibility if required. The self-healing property allows the implant to repair minor damages over time, ensuring long-term durability while also permitting controlled access for future interventions.
[0041] In an embodiment, the implant includes a sealing member and a plurality of anchors. The sealing member is made of a self-healing material, which enhances the stability and adaptability of the implant against the septal tissue. The plurality of anchors ensures a secure grip on the septal tissue. In an embodiment, each of the anchors of the implant have a head with a plurality of slots. Upon deployment, the heads of the anchors encircle the defect, ensuring effective closure of the defect. The slots provided on the head of each anchor enhance compressibility of the head. This not only facilitates smoother insertion of the anchors through the septum wall but also allow the anchors to pass through implantation holes of smaller diameter compared to conventional implants, minimizing trauma to the surrounding tissue while ensuring a firm and secure placement. At least a portion of the stems of the anchors are disposed inside the septum wall. The anchors aid in stabilizing the implant against the septum, preventing migration and ensuring a firm placement. The same implant is able to provide closure for a broader range of septal defect sizes, thereby minimizing the inventory requirements for the operator while providing an immediate impact on the patient’s life. The ability of a single implant size to close multiple defect sizes is achieved through the flexible sealing member and the compressible, self-expanding anchors. The sealing member adapts to different defect sizes by expanding or overlapping as needed, ensuring effective occlusion. Additionally, the anchors expand radially to provide a secure fit within the septal wall. This radial adaptability allows a single implant size to accommodate multiple defect sizes while ensuring strong fixation, reduced trauma, and enhanced adaptability during implantation.
[0042] The proposed implant may be implanted through a surgical procedure or through a minimally invasive procedure. The present disclosure also discloses a delivery system for delivering the implant. The delivery system enables the implant to be delivered in a minimally invasive manner. The delivery system allows for a controlled and precise deployment of the implant.
[0043] Now referring to figures, Fig. 1A depicts a perspective view and Fig. 1B depicts a cross-sectional view of an implant 100 to occlude a septal defect, in accordance with an embodiment of the present invention. The implant 100 has a proximal end 100a and a distal end 100b. The implant 100 is used to occlude (or close) a septal defect (interchangeably referred to as a defect) inside a patient’s heart. The implant 100 is capable of closing the septal defect immediately upon deployment, unlike conventional occluders that rely on tissue ingrowth over time. The immediate closure is achieved by a self-healing, flexible sealing member (102) that instantly conforms to the defect, while radial expansion and secure anchoring provide a tight seal. The implant 100 may be made of a biocompatible material having self-healing properties. Thus, the implant 100 is able to automatically repair small cracks or damages to its structure, which extend the lifespan of the implant 100 and improve the patient outcomes. Examples of such self-healing, biocompatible materials that may be used to make the implant 100 include, without limitation, silicone, polymers, polyether ether ketone (PEEK), expanded polytetrafluoroethylene (ePTFE), Polyurethane (PU), Polylactic Acid (PLA), hydrogels or combinations thereof. In an example implementation, the implant 100 is made of silicone and Polyether ether ketone (PEEK). The implant 100 is suitable for both surgical and minimally invasive implantation procedures.
[0044] In an embodiment, the implant 100 includes a sealing member 102 and a plurality of anchors 104. The sealing member 102 is positioned at the proximal end 100a of the implant 100. A distal face 102a of the sealing member 102 is configured to contact the septal wall, for example, a portion surrounding the septal defect. The sealing member 102 is made of a self-healing, biocompatible material. The sealing member 102 comprises a first portion 102b and a second portion 102c surrounding the first portion 102b. A proximal face of each of the first portion 102b and the second portion 102c are flush with each other. The first portion 102b has a first thickness W1 and the second portion 102c has a second thickness W2. In an embodiment, the first thickness W1 of the first portion 102b is lower than the second thickness W2 of the second portion 102c, defining a cavity 102d extending from a distal end of the sealing member 102 towards a proximal end of the sealing member 102. The first portion 102b aligns with the septal defect and closes the septal defect by directly interacting with it after the implant 100 is deployed. The cross-sectional area of the first portion 102b is greater than or equal to the size of the defect. The cavity 102d in the first portion 102b deforms upon contact with the defect, allowing the implant 100 to expand radially, conform to the septal wall, and absorb mechanical stress. This mechanism ensures a tight seal, immediate closure, and long-term stability without exerting excessive force. The flexibility of the sealing member 102 and relatively smaller thickness of the first portion 102b allows the cavity 102d to expand radially during heart pumping. As a result, the implant 100 is capable of changing its shape in synchronization effectively with the rhythm of the heart unlike conventional implants. This ensures long-term stability, reduced tissue stress, improved sealing, and enhanced patient comfort by synchronizing with the heart’s natural motion. In an embodiment, a ratio R of first thickness W1 to second thickness W2 ranges from 0.3 to 0.7. More preferably, the ratio R ranges between 0.4 and 0.6. In an exemplary implementation, the ratio R is 0.5.
[0045] The first portion 102b and the second portion 102c of the sealing member 102 may have pre-defined cross-sectional shape, such as, without limitation, circular, oval, rectangular, square, polygonal, etc. In an embodiment, the first portion 102b and the second portion 102c has a circular cross-section. In various embodiment, the first portion 102b is polygonal and the second portion 102c is circular or vice versa. The dimensions of the first portion 102b and the second portion 102c may be chosen based upon requirements. In an embodiment, the diameter of the second portion 102c ranges from 24 mm to 26 mm, and the diameter of the first portion 102b ranges from 14 mm to 16 mm. In an exemplary embodiment, the second portion 102c has a diameter of 25 mm, and the first portion 102b has a diameter of 15 mm. The first thickness W1 of the first portion 102b may range from 0.8 mm to 1.2 mm and the second thickness W2 of the second portion 102c may range from 1.8 mm to 2.2 mm. In an embodiment, the first thickness W1 of the first portion 102b and the second thickness W2 of the second portion 102c are 1 mm and 2 mm, respectively. The first portion 102b and the second portion 102c are made of a self-healing, biocompatible material. The first portion 102b and the second portion 102c may be made of the same or different material. In an embodiment, the first portion 102b and the second portion 102c are made of different materials. In an exemplary embodiment, first portion 102b of the sealing member 102 is made of silicone for flexibility and self-healing, while the second portion 102c and the anchors 104 are made of PEEK for structural stability and secure fixation, allowing optimized strength, stretchability, and sealing performance.
[0046] The plurality of anchors 104 (hereinafter, anchors 104) is provided on the second portion 102c and extends perpendicularly from a distal face 102a of the second portion 102c towards the distal end 100b of the implant 100. The anchors 104 are configured to penetrate the wall of the septum surrounding the septal defect. When the implant 100 is implanted, a portion of the anchors 104 resides within the septum wall. The anchors 104 provide a firm grip to the implant 100 on the septum wall. The anchors 104 may have various shapes, including but not limited to, arrow, dome, barbed, hooked, screw-like, flanged, tapered, etc. In an embodiment, the anchors 104 are in the shape of an arrow. The anchors 104 are arranged circumferentially on the second portion 102c. The anchors 104 may be distributed uniformly or non-uniformly. The number of anchors 104 may be chosen based upon the radial size of the sealing member 102. In an embodiment, the number of anchors 104 may range from 6 to 12. In an exemplary embodiment, the implant 100 includes eight anchors 104 distributed evenly. The even distribution of the anchors 104 distributes stresses more evenly, enhancing the stability of the implant 100 at the target site and reducing the risk of migration. The length of the anchors 104 is in a range of 3.5 mm to 5 mm. In an embodiment, the length of the anchors 104 is 4 mm.
[0047] Fig. 1C depicts a perspective view and Fig. 1D depicts a cross-sectional view of one anchor 104 of the plurality of anchors 104, in accordance with an embodiment of the present invention. In an embodiment, each anchor 104 includes a stem 104a and a head 104b. The stem 104a extends longitudinally from the distal face 102a of the second portion 102c of the sealing member 102. The stem 104a may have a pre-defined shape such as cylindrical, cuboidal, tapered, conical, etc. In an embodiment, the stem 104a has a cylindrical shape. At least a portion of the stem 104a is configured to penetrate and reside within the septum wall upon implantation. The length of the stem 104a may range from 2.5 mm to 4 mm. In an embodiment, the length of the stem 104a is 3 mm. The diameter of the stem 104a may range between 0.6 mm and 1 mm. In an example implementation, the diameter of the stem 104a is 0.8 mm.
[0048] The head 104b is positioned at the distal end of the stem 104a and extends toward the distal end 100b of the implant 100. The head 104b is configured to reside outside the septum wall after implantation, preventing the implant 100 from migrating or dislodging. A diameter of the head 104b at a proximal end of the head 104b (hereinafter referred to as a proximal diameter of the head 104b) is larger than the diameter of the stem 104a, creating a step-like transition that enhances secure placement by resisting excessive movement through the defect site. The diameter difference also serves as a stopper, ensuring the implant 100 remains correctly positioned after implantation. The head 104b may have various shapes including, but not limited to, cylindrical, conical, frustum, etc. In an example implementation, the head 104b has conical shape. The length of the head 104b may range from 1.5 mm to 3 mm. In an embodiment, the length of the head 104b is 2 mm. The proximal diameter of the head 104b may range from 1.5 mm to 2.5 mm. In an example implementation, the proximal diameter of the head 104b is 2 mm.
[0049] The head 104b includes a plurality of slots 104b1. The slots 104b1 are provided circumferentially. The slots 104b1 extend from the proximal end of the head 104b towards a distal end of the head 104b for a partial length of the head 104b. The slots 104b1 make the head 104b compressible, facilitating easier penetration of the anchors 104 through the septum wall, making the deployment of the implant 100 more efficient and faster. For example, when the anchors 104 are inserted through the septum wall, the heads 104b of the anchors 104 are radially compressed due to the pressure applied by the septum wall. When the heads 104b of the anchors 104 exit the septum wall at a distal side, the heads 104b regain their original structure, preventing displacement towards proximal direction and securing the position of the implant 100. The slots 104b1 may be distributed uniformly or non-uniformly. In an embodiment, the slots 104b1 are distributed evenly, enabling more uniform penetration through the septum wall and leading to an accurate positioning of the implant 100. In an embodiment, longitudinal edges of each slot 104b1 make a pre-defined angle. The pre-defined angle may range between 40 degrees and 60 degrees. In an exemplary embodiment, the pre-defined angle is 50 degrees. The number of slots 104b1 may be in the range from 2 to 4. In an exemplary embodiment, the head 104b of each anchor 104 has four slots 104b1. The length of the slots 104b1 may range between 1 mm and 1.5 mm. In an embodiment, the length of the slots 104b1 is 1.2 mm.
[0050] Fig. 2A depicts a perspective view and Fig. 2B depicts an exploded view of a delivery system 200, in accordance with an embodiment of the present invention. The delivery system 200 has a proximal end 200a and a distal end 200b. In an embodiment, the delivery system 200 includes a gripping assembly 300, an inner shaft 400, a control element 450, an outer shaft 500, and a handle 600. The delivery system 200 is used for delivering and deploying an implant for closing a septal defect, such as, the implant 100. The delivery system 200 allows for an accurate placement of the implant 100. The gripping assembly 300 secures the implant 100 through delivery and deployment of the implant 100 to a target site. The control element 450 allows a user to control the gripping assembly 300 to deploy the implant 100 as explained later.
[0051] Fig. 3 depicts a perspective view of an outer shaft 500, in accordance with an embodiment of the present disclosure. The outer shaft 500 has a proximal end 500a and a distal end 500b. The outer shaft 500 is coupled to the handle 600 at the proximal end 500a. The outer shaft 500 has an elongated, tubular structure and includes a lumen 500c. The lumen 500c is configured to receive the inner shaft 400 and gripping assembly 300. The outer shaft 500 is configured to apply constraining force on the gripping assembly 300. The length of the outer shaft 500 may be chosen based upon procedural requirements and the diameter of the outer shaft 500 may be designed according to the size of the implant 100. In an embodiment, the length of the outer shaft 500 may range between 900 mm and 1100 mm, the outer diameter of the outer shaft 500 may range between 3 mm and 4.5 mm, and the inner diameter of the outer shaft 500 may range between 2.5 mm and 3.8 mm. In an example implementation, the length, the outer diameter and the inner diameter of the outer shaft 500 are 1000 mm, 3.5 mm and 3mm, respectively. The outer shaft 500 may be made of a biocompatible material including, without limitation, PTFE, PEEK, polyurethane, stainless steel, etc. In an example implementation, the outer shaft 500 is made of PTFE coated stainless steel. The outer shaft 500 may be a catheter or an introducer sheath.
[0052] Fig. 4 depicts a perspective view of an inner shaft 400, in accordance with an embodiment of the present invention. The inner shaft 400 has a proximal end 400a and a distal end 400b. The inner shaft 400 extends longitudinally and has an elongated body. The inner shaft 400 is disposed within the lumen 500c of the outer shaft 500. In an embodiment, the inner shaft 400 has a cylindrical body though it may have any other suitable shape. The inner shaft 400 may have a solid or hollow core for at least a partial length of the inner shaft 400. In an embodiment, the inner shaft 400 has a solid core for the entire length of the inner shaft 400.
[0053] The proximal end 400a of the inner shaft 400 is coupled to the control element 450. The inner shaft 400 is configured to move axially in response to an actuation input received by the control element 450. The distal end 400b of inner shaft 400 is coupled to the gripping assembly 300. The inner shaft 400 facilitates the radial expansion and collapse of the gripping assembly 300 as explained later. The dimensions of the inner shaft 400 may be chosen based upon procedural requirements. In an embodiment, the length of the inner shaft 400 may range between 850 mm and 1050 mm, and the diameter of the inner shaft 400 may range between 1.5 mm and 2.5 mm. In an example implementation, the length and the diameter of the inner shaft 400 are 950 mm, and 2 mm, respectively. The inner shaft 400 may be made of a biocompatible material including, without limitation, PTFE, PEEK, polyurethane, stainless steel, etc. In an example implementation, the inner shaft 400 is made of PEEK.
[0054] Fig. 5A depicts a perspective view of a gripping assembly 300, in accordance with an embodiment of the present invention. The gripping assembly 300 is positioned at the distal end 200b of the delivery system 200. The gripping assembly 300 is configured to grip (or hold) the implant 100 during deployment. The gripping assembly 300 has a proximal end 300a and a distal end 300b. The gripping assembly 300 includes a coupling element 302 and a plurality of gripping members 304. The gripping assembly 300 is radially expandable and collapsible to facilitate engaging and releasing the implant 100 during deployment.
[0055] The coupling element 302 is provided at the proximal end 300a of the gripping assembly 300. The coupling element 302 is coupled to the distal end 400b of the inner shaft 400. The coupling element 302 serve as coupling means for the plurality of gripping members 304 and the inner shaft 400. In an embodiment, the coupling element 302 has a generally circular shape, in the form of a ring. The coupling element 302 includes an opening 302a. The opening 302a may be provided centrally and extends for the entire length of the coupling element 302. The opening 302a receives the distal end 400b of the inner shaft 400. The opening 302a may be fixedly or removably coupled to the inner shaft 400 using technique, such as, without limitation, fitting, adhesive bonding, threaded coupling, or laser welding, etc. In an embodiment, the opening 302a is fixedly coupled to the inner shaft 400 using laser welding. The diameter of the opening 302a corresponds to the outer diameter of the inner shaft 400. The coupling element 302 may be made of a biocompatible material including, without limitation, PEEK, titanium, stainless steel polyurethane, etc. In an example embodiment, the coupling element 302 is made of PEEK. The structure of the coupling element 302 described herein should not be considered as limiting and the coupling element 302 may have any other structure capable of coupling with the inner shaft 400. It should be noted that the coupling element 302 may be optional and the gripping members 304 are directly coupled to the inner shaft 400.
[0056] The plurality of gripping members 304 coupled to the inner shaft 400. The plurality of gripping members 304 are coupled to a distal end of the coupling element 302. The gripping members 304 are coupled to the coupling element 302 using technique, such as, without limitation, press fitting, adhesive bonding, laser welding, mechanical fasteners, etc. In an embodiment, the gripping members 304 are coupled to the coupling element 302 using laser welding. The gripping members 304 are configured to grip the implant 100. The gripping members 304 are arranged circumferentially (uniformly or non-uniformly) about a central axis of the gripping assembly 300. In an embodiment, the gripping members 304 are uniformly arranged. Consequently, the implant 100 is gripped uniformly and a more even pressure is applied on the implant 100 during the deployment process, resulting in a controlled and precise deployment, and preventing damage to the implant 100. The number of the gripping members 304 may be chosen based upon requirements. In an embodiment, the number of the gripping members 304 may be between 3 and 6, and preferably, between 3 and 5. In an example implementation, the gripping assembly 300 includes four gripping members 304.
[0057] Each of the gripping members 304 includes an elongated portion 304a and a claw 304b. The elongated portion 304a is provided at a proximal end of the gripping member 304. The elongated portion 304a extends from a proximal end of the gripping members 304 toward a distal end of the gripping member 304. The elongated portion 304a may have a pre-defined shape including, without limitation, bar, rod, tube, cylinder etc. In an exemplary embodiment, the elongated portion 304a is in the form of a rectangular plate. A proximal end of the elongated portion 304a is coupled to the inner shaft 400 via the coupling element 302. The elongated portion 304a is slanted, making a pre-defined angle A with a longitudinal axis B of the gripping assembly 300. The elongated portion 304a of the gripping member 304 is configured to move (or flex) radially inward (i.e., towards the longitudinal axis B) and outward (i.e., away from the longitudinal axis B) based upon the presence or absence of the constraining force applied by the outer shaft 500.
[0058] The claw 304b is located at the distal end of the gripping member 304. In an embodiment, each elongated portion 304a is integrally coupled to the claw 304b. It is possible however that the elongated portion 304a and the claw 304b are separate components coupled together using a suitable coupling technique. The claw 304b is configured to hold the implant 100 for the deployment. The claw 304b has a slot 304b1 configured to receive and grip a portion of the implant 100. In an embodiment, the slot 304b1 is configured to receive a part of an outer periphery of the second portion 102c of the sealing member 102. The slot 304b1 has a pre-defined shape that corresponds to the peripheral edge of the second portion 102c of the sealing member 102 of the implant 100. The claw 304b has a pre-defined shape including, without limitation, C-shape, U-shape, V shape, hook shape, oval shape, flat end shape, and tapered shape etc. depending on the shape of the implant 100. The gripping assembly 300 has a diameter defined as a distance between the farthest slot 304b1.
[0059] The gripping assembly 300 is configured to move axially in response to the axial movement of the inner shaft 400. The direction of movement of the gripping assembly 300 is the same as that of the inner shaft 400. The gripping members 304 are configurable to be in one of: an undeployed state (interchangeably referred to as crimped or a radially collapsed or compressed state), a partially deployed state (interchangeably referred to as a partially expanded state), and a fully deployed state (interchangeably referred to as a fully expanded state). The movement between these states is controlled by the axial movement of the inner shaft 400 and the position of the gripping members 304 with respect to the outer shaft 500, which in turn is controlled by the control element 450. In the undeployed state, the gripping members 304 are completely enclosed within the outer shaft 500, i.e., the distal end of the gripping members 304 is proximal to the distal end 500b of the outer shaft 500. The outer shaft 500 is configured to apply a constraining force on the gripping members 304, causing the elongated portions 304a of the gripping members 304 to flex radially inward. In the undeployed state, the outer shaft 500 applies the maximum constraining force on the gripping members 304. In this state, the gripping assembly 300 has a minimum diameter and the gripping members 304 have a minimal radial profile. The minimum diameter is designed to be less than the outer diameter of the second portion 102c of the implant 100. Thus, when the gripping assembly 300 is in the crimped state, The implant 100 too is radially crimped, conforming to the internal dimensions of the outer shaft 500. At this stage, the sealing member 102 of the implant 100 is radially compressed, taking, for example, a conical profile to fit within the inner diameter of the outer shaft 500. The conical shape of the implant 100 ensures that the peripheral edge of the sealing member 102 nests within the slots 304b1. This facilitates deployment of the implant 100 in a minimally invasive manner.
[0060] In response to the movement of the inner shaft 400 in a distal direction, the gripping assembly 300 is configured to move in the distal direction. When the distal end 300b of the gripping assembly 300 moves out of the outer shaft 500, resulting in the partial exposure of the gripping assembly 300 from the outer shaft 500. A portion of the gripping members 304 disposed out of the outer shaft 500 experiences no constraining force. Consequently, the elongated portions 304a of the gripping members 304 begin to flex radially outward and the diameter of the gripping assembly 300 increase. In the partially deployed state, the gripping members 304 (and the corresponding elongated portions 304a) are partially disposed inside the outer shaft 500 and are partially disposed outside the outer shaft 500. In this state, the proximal end of the elongated portions 304a remains proximal to the distal end 500b of the outer shaft 500. Therefore, the elongated portions 304a do not reach at maximum expansion. In the partially expanded state, the gripping assembly 300 has a first diameter. The first diameter is greater than the minimum diameter of the gripping assembly 300 in the crimped state and is equal to the diameter of sealing member 102 of the implant 100. Therefore, the implant 100 remains engaged with the gripping assembly 300 despite partial expansion of the gripping assembly 300. The partially deployed state of the gripping assembly 300 and the implant 100 is shown in Fig. 5B.
[0061] When the inner shaft 400 is moved further in the distal direction such that the proximal end 300a of the gripping assembly 300 is disposed distal to the distal end 500b of the outer shaft 500. Thus, the gripping assembly 300 moves completely outside the outer shaft 500. Since there is no constraining force applied by the outer shaft 500 on the gripping members 304, the gripping members 304 flex radially outward to a maximum degree to be the fully expanded state. The elongated portions 304a radially expand to their maximum expanded position. In the fully deployed state, the gripping members 304 are fully disposed outside the outer shaft 500 to release the implant 100. In an embodiment, in the fully deployed state, the elongated portion 304a are configured to flex radially outward and make the pre-defined angle A with the longitudinal axis B. The pre-defined angle A is designed such that a maximum diameter attained by the gripping assembly 300 in the fully deployed state is greater than the diameter of the sealing member 102. For example, the claw 304b of the gripping members 304 achieve a diameter larger than the diameter of the sealing member 102 of the implant 100. Consequently, the implant 100 is released from the claw 304b of the gripping assembly 300 and deployed at the target site. Fig. 5C depicts the implant 100 and the gripping assembly 300 in the fully deployed state.
[0062] Similarly, when the gripping assembly 300 is in the fully expanded state and the inner shaft 400 is gradually moved in the proximal direction, the gripping members 304 begins to retract into the outer shaft 500. As the gripping members 304 re-enter the outer shaft 500, the constraining force applied by the outer shaft 500 increases, causing the elongated portions 304a to flex radially inward. Consequently, the gripping assembly 300 transitions from the fully expanded state to the partially expanded state, and further to the undeployed state when completely enclosed by the outer shaft 500.
[0063] The gripping members 304 may be made of a biocompatible material including, without limitation, PEEK, polyurethane, stainless steel, titanium, etc. In an example implementation, the gripping members 304 are made of PEEK. The dimensions of the elongated portion 304a and the claw 304b may be chosen based on the size of the implant 100 and procedural requirements. In an embodiment, the length of the elongated portion 304a may range between 8 mm and 12 mm, and the length of the claw 304b may range between 4 mm and 6 mm. In an example implementation, the length of the elongated portion 304a and the claw 304b are 10 mm, and 5 mm, respectively.
[0064] The control element 450 is coupled to the inner shaft 400 and facilitates the axial movement of the inner shaft 400, resulting in the radial movement of the gripping members 304 of the gripping assembly 300. The control element 450 is configured to move the inner shaft 400 axially and is configured to trigger the gripping members 304 to be in one of: the undeployed state, the partially deployed state and the fully deployed state. In response to the actuation input received by the control element 450, the inner shaft 400 is configured to move axially. The control element 450 may be a sliding button, a roller, or the like. Fig. 6 depicts a perspective view of a control element 450, in accordance with an embodiment of the present invention. In the depicted embodiment, the control element 450 is a sliding button. The control element 450 is slidably disposed within the handle 600. The control element 450 includes a first portion 452, a second portion 454 and a third portion 456. The first portion 452 is positioned at a top end of the control element 450. The third portion 456 is positioned at a bottom end of the control element 450. The second portion 454 extends between the first portion 452 and the third portion 456. The first portion 452 allows the user to hold and manipulate the control element 450. In an embodiment, the first portion 452 includes a grip 452a. The grip 452a may have multiple parallel ridges provided on its top surface, that facilitates a better grip to the user and allows easier manipulation of the control element 450. It should be understood that the top surface of the grip 452a may have other features, such as, grooves, undulations, or the like, instead of, or in addition to, the ridges. The first portion 452 protrudes out of the handle 600. The first portion 452 may have a shape, such as, without limitation, cuboidal, cylindrical, etc. In an embodiment, the first portion 452 is a semi-cylinder.
[0065] The second portion 454 extends vertically downward from the first portion 452, forming a T-shaped structure. The second portion 454 is at least partially disposed in the handle 600. The second portion 454 may have a shape, such as, without limitation, cuboidal, cylindrical, etc. In an embodiment, the second portion 454 is cuboidal. The second portion 454 and the third portion 456 are coupled, forming a T- shaped structure. The third portion 456 resides within handle 600. The third portion 456 includes a cavity (not shown). The proximal end 400a of the inner shaft 400 is inserted into the cavity within the third portion 456. The third portion 456 is coupled to the inner shaft 400 using, a technique such as, without limitation, press-fitting, adhesive bonding, threaded coupling, etc. In an example implementation, the third portion 456 is coupled to the inner shaft 400 using adhesive bonding. The third portion 456 may have a shape, such as, without limitation, cube, cuboidal, cylindrical, etc. In an embodiment, the third portion 456 is a cube. The control element 450 may be made of a material including, without limitation, acrylonitrile butadiene styrene (ABS), polycarbonate, stainless steel, etc. In an example implementation, the control element 450 is made of ABS.
[0066] The control element 450 is capable of receiving a first actuation input and a second actuation input. In response to the control element 450 receiving the first actuation input, the inner shaft 400 is configured to move axially in the distal (or forward) direction. The distal movement of the inner shaft 400 causes the gripping assembly 300 to advance and gradually exit the outer shaft 500. As the gripping assembly 300 is exposed, the constraining force applied by the outer shaft 500 is reduced, allowing the gripping members 304 to radially expand as explained earlier. In response to the control element 450 receiving the second actuation input, the inner shaft 400 is configured to move axially in a proximal (or backward direction). As the inner shaft 400 gradually moves inside the outer shaft 500, the gripping assembly 300 radially collapses as described earlier. According to an embodiment, the first actuation input and the second actuation input correspond to sliding (or moving) the control element 450. In another embodiment, the control element 450 may be a roller (not shown). In this case, the first and second actuation inputs may correspond to rotating the control element 450 in a first and a second direction, respectively. The control element 450 may be coupled to the inner shaft 400 such that rotating the control element 450 in the first direction causes the inner shaft 400 to axially move in the distal direction and rotating the control element 450 in the second direction causes the inner shaft 400 to axially move in the proximal direction. The first direction may be clockwise and the second direction may be anticlockwise, or vice versa.
[0067] The handle 600 is disposed at the proximal end 200a of the delivery system 200. Fig. 7A depicts a perspective view and Fig. 7B depicts a cross-sectional view of a handle 600, in accordance with an embodiment of the present disclosure. The handle 600 is used for holding and maneuvering the delivery system 200 to deploy the implant 100 of the present disclosure. The handle 600 has a proximal end 600a and a distal end 600b. The handle 600 is ergonomically designed to provide an optimized grip of the delivery system 200. In an embodiment, handle 600 has an elongated, generally cuboidal shape. The proximal end 500a of the outer shaft 500 is coupled with the distal end 600b of the handle 600. The outer shaft 500 is coupled to the handle 600 using press-fitting, adhesive bonding, laser welding, threaded coupling, etc. In an example implementation, the distal end 600b of the handle 600 is coupled to the proximal end 500a of the outer shaft 500 using adhesive bonding. The handle 600 may be made of a material including, but not limited to, polycarbonate (PC), polyethylene terephthalate glycol (PETG), ABS, PEEK, etc. In an example implementation, the handle 600 is made of ABS.
[0068] The handle 600 is at least partially hollow and includes a cavity 600c. The cavity 600c of the handle 600 is configured to receive a proximal portion of the inner shaft 400. The handle 600 includes a channel 600d extending from the distal end 600b towards the proximal end 600a. In an embodiment, the channel 600d extends into the cavity 600c. The channel 600d is configured to receive the inner shaft 400. The dimensions of the channel 600d are designed to allow longitudinal or axial movement of the inner shaft 400. The handle 600 includes a longitudinal slot 602 configured to receive the control element 450, for example, the second portion 454 of the control element 450. The longitudinal slot 602 extends into the cavity 600c of the handle 600 and extends longitudinally for at least a partial length of the handle 600. The cavity 600c is configured to receive the third portion 456 of the control element 450 i.e., the third portion 456 resides within the cavity 600c of a handle 600. The longitudinal slot 602 has a proximal end 602a and a distal end 602b. The control element 450 is movable within the longitudinal slot 602 between the proximal end 602a and the distal end 602b. In response to the movement of the control element 450 towards the distal end 602b, the inner shaft 400 is configured to move axially in a distal direction. The cross-sectional shape and dimensions of the longitudinal slot 602 correspond to the cross-sectional shape and dimensions of the second portion 454 of the control element 450.
[0069] The position of the control element 450 within the longitudinal slot 602 is adjusted to control the state of the gripping members 304. When the control element 450 is at the proximal end 602a of the longitudinal slot 602, the inner shaft 400 and the gripping assembly 300 (including the gripping members 304) reside within the outer shaft 500, and the gripping members 304 are flexed radially inward to be in the undeployed state. Thus, in the undeployed state, the control element 450 is at the proximal end 602a of the longitudinal slot 602. The length of the longitudinal slot 602 may be designed such that when the control element 450 is the distal end 602b of the longitudinal slot 602, the gripping members 304 are completely disposed outside the outer shaft 500 to be in the fully deployed state as described earlier. Thus, in the fully deployed state, the control element 450 is at the distal end 602b of the longitudinal slot 602. In an embodiment, when the control element 450 is disposed at a first intermediate position between the proximal end 602a and the distal end 602b of the longitudinal slot 602, the inner shaft 400 is moved in the distal direction such that the gripping members 304 are partially disposed inside the outer shaft 500 and partially disposed outside the outer shaft 500 and the gripping members 304 are in the partially deployed state as described earlier. Thus, in the partially deployed state, the control element 450 is at the first intermediate position.
[0070] The handle 600 includes a first lateral groove 602c and a second lateral groove 602d extending laterally from the longitudinal slot 602 towards a second lateral end 600f of the handle 600. The first lateral groove 602c and second lateral groove 602d help in locking and unlocking the control element 450 at predefined locations. The distance between the first lateral groove 602c and the second lateral groove 602d is determined based on the required axial displacement of the inner shaft 400 to achieve the transition from the crimped state to the partially expanded states of the gripping members 304. The longitudinal slot 602 includes a first notch 608 and a second notch 610 provided towards a first lateral end 600e of the handle 600 as shown in Fig. 11A. The first notch 608 is aligned with the first lateral groove 602c and the second notch 610 is aligned with the second lateral groove 602d.
[0071] The handle 600 of the delivery system 200 further includes a first locking member 604 and a second locking member 606. The first locking member 604 and the second locking member 606 are disposed in the first lateral groove 602c and the second lateral groove 602d, respectively. Further, the first locking member 604 and the second locking member 606 are configured to slide within the first lateral groove 602c and the second lateral groove 602d, respectively i.e. the second notch 610 aligned with the second lateral groove 602d and configured to engage with the second locking member 606 when the second locking member 606 is disposed at the second locked position 700c. The first locking member 604 and a second locking member 606 are provided to lock the control element 450 in the longitudinal slot 602 at a respective predefined position and thus, control the deployment of the implant 100 and avoid premature deployment. In an embodiment, the structure of the first locking member 604 and the second locking member 606 is identical. The first locking member 604 has a base section 604a provided at a bottom end of the first locking member 604 and a grip section 604b provided at a top end of the first locking member 604. In an embodiment, the base section 604a has a cuboidal shape and the grip section 604b is semi-circular, forming a D-shaped. Similarly, the second locking member 606 includes a base section 606a and a grip section 606b. The base sections 604a and 606a are configure to reside in the first lateral groove 602c and the second lateral groove 602d, respectively. The first locking member 604 is configurable to be in a first locked position 700a and a first unlocked position 700b. In the first locked position 700a, the first locking member 604 is disposed towards the first lateral end 600e such that a first end of the first locking member 604 is configured to engage with the first notch 608 and a second end of the first locking member 604 is disposed within the first lateral groove 602c as shown in Fig. 9A. i.e. the first notch 608 aligned with the first lateral groove 602c and configured to engage with the first locking member 604 when the first locking member 604 is disposed at the first locked position 700a. At this position, the first locking member 604 prevents movement of the control element 450 within the longitudinal slot 602 beyond the first locked position 700a either in the proximal or in the distal direction, thereby locking the position of the control element 450. In the first unlocked position 700b, the first locking member 604 is disposed towards the second lateral end 600f such that the first and the second end of the first locking member 604 are disposed in the first lateral groove 602c as shown in Fig. 10A. Consequently, the control element 450 is unlocked and is able to slide within the longitudinal slot 602. The first locking member 604 is movable in the first lateral groove 602c between the first locked position 700a and the first unlocked position 700b, wherein in the first locked position 700a, the first locking member 604 is configured to lock the control element 450 at the proximal end 602a of the longitudinal slot 602. Similarly, the second locking member 606 is configurable in a second locked position 700c and a second unlocked position 700d. In the second locked position 700c, the second locking member 606 is disposed towards the first lateral end 600e such that a first end of the second locking member 606 engages with the second notch 610, and a second end of the second locking member 606 resides within the second lateral groove 602d as shown in Fig. 9A, restricting the movement of the control element 450. In the second unlocked position 700d, the second locking member 606 is disposed towards the second lateral end 600f such that both the first end and the second end of the second locking member 606 are disposed within the second lateral groove 602d as shown in Fig. 11A, disengaging from the second notch 610. The second locking member 606 is movable in the second lateral groove 602d between a second locked position 700c and a second unlocked position 700d. In the second locked position 700c, the second locking member 606 is configured to lock the control element 450 at a first intermediate position. In the second unlocked position 700d, the second locking member 606 allows the control element 450 to move freely within the longitudinal slot 602. By controlling the positions of the first locking member 604 and the second locking member 606, the control element 450 is locked at a respective position, preventing accidental movement of the control element 450 and increasing the accuracy and reliability of the deployment of the implant 100.
[0072] Fig. 8 depicts a flowchart of a method 800 of using the delivery system 200 to deploy an implant (such as, the implant 100) to close a septal defect in a septum wall 10, in accordance with an embodiment of the present invention The method 800 may be performed under an imaging guidance technique, for example, fluoroscopy.
[0073] At step 801, the delivery system 200 along with the implant 100 loaded in the delivery system 200 is advanced through the patient's vasculature to a target deployment site inside a patient’s heart. The distal end 500b of the outer shaft 500 maneuvered to align with the target deployment site. During this step, the control element 450 is positioned at the proximal end 602a of the longitudinal slot 602. The first locking member 604 and second locking member 606 are at the first locked position 700a and the second locked position 700c, respectively. When the control element 450 is at the proximal end 602a of the longitudinal slot 602, the inner shaft 400 is at a default position such that the gripping assembly 300 and the implant 100 engaged with the gripping members 304 are disposed inside the lumen 500c of the outer shaft 500. The outer shaft 500 applies a constraining force on the gripping members 304, pushing them radially inward. This inward flexing of the gripping members 304 causes the implant 100 to be radially compressed, conforming to the inner shape of the outer shaft 500 and taking on a conical configuration. This ensures secure retention of the implant 100 and facilitates smooth navigation. The implant 100 is said to be in the undeployed state. Fig. 9A shows the configuration of the control element 450, the first locking member 604 and the second locking member 606 in the undeployed state. Fig. 9B illustrates the gripping assembly 300 and the implant 100 in the undeployed state.
[0074] At step 803, upon reaching the deployment site, the first locking member 604 is moved to the first unlocked position 700b by sliding the first locking member 604 laterally into the first lateral groove 602c towards the second lateral end 600f of the handle 600 as shown in Fig. 10A. This unlocks the control element 450, allowing a subsequent movement of the control element 450.
[0075] At step 805, the control element 450 is slid in the longitudinal slot 602 in a distal direction to the first intermediate position as depicted in Fig. 10A. Further, the first position is proximal to the second locked position 700c of the second locking member 606. The second locking member 606 remains at the second locked position 700c and prevents further movement of the control element 450. The movement of the control element 450 in the distal direction to the first intermediate position, causes the inner shaft 400 to move in the distal direction. The gripping members 304 begin to emerge from the distal end 500b of the outer shaft 500. There is no constraining force on a portion of the gripping members 304 positioned outside the outer shaft 500. As a result, the gripping members 304 flex radially outward and the diameter of the gripping assembly 300 increases, and the implant 100 starts regaining its original shape. The first intermediate position of the control element 450 is designed such that the diameter of the gripping assembly 300 is equal to the diameter of the sealing member 102 of the implant 100. Thus, at the first intermediate position of the control element 450, the implant 100 regains its original shape but remains engaged with the slots 304b1 of the claws 304b of the gripping members 304. At this stage, the gripping assembly 300 is at the partially deployed state and the implant 100 is at the partially deployed state. Fig. 10A depicts the configuration of the control element 450, the first locking member 604 and the second locking member 606 at the partially deployed state. Fig. 10B depicts the gripping assembly 300 and the implant 100 in the partially deployed state. Once the implant 100 is in the partially deployed state, the position of the delivery system 200 may be adjusted using the handle 600 such that the implant 100 is positioned against a defect 10a of the septum wall 10. In an embodiment, the implant 100 is positioned such that the first portion 102b aligns with the defect 10a and an inner edge of the second portion 102c encircles the defect 10a.
[0076] At step 807, the implant 100 is implanted at the target deployment site, for example, by pushing the delivery system 200 in the distal direction. The anchors 104 of the implant 100 begin penetrating the heart septum 10. As described earlier, the heads 104b of the anchors 104 are compressed due to the slots 104b1, facilitating easier entry of the anchors 104 through the septum wall 10. The delivery system 200 is pushed until the anchors 104 emerge from a distal side of the septum wall 10. The heads 104b of the anchors 104 return to their original shape after penetration, ensuring a stable grip and preventing migration of the implant 100. The distal face 102a of the second portion 102c of the sealing member 102 contacts a proximal side of the septum wall 10 and the first portion 102b of the sealing member 102 surrounds the defect 10a. As explained earlier, due to smaller thickness of the first portion 102b, there is a gap between a distal face 102a of the first portion 102b and the septum wall 10. The implant 100 remains engaged with the gripping members 304 at this stage as shown in Fig. 10C.
[0077] At step 809, the second locking member 606 is disengaged by sliding it laterally into the second lateral groove 602d in the second unlocked position 700d as shown in Fig. 11A. This allows the sliding movement of the control element 450 towards the distal end 602b of the longitudinal slot 602.
[0078] At step 811, the control element 450 is slid further to the distal end 602b of the longitudinal slot 602 of the handle 600 (as shown in Fig. 11A) to release the implant 100 from the delivery system 200. The movement of the control element 450 causes the inner shaft 400 moves forward such that the distal end 400b of the inner shaft 400 is distal to the distal end 500b of the outer shaft 500. The gripping members 304 are positioned completely outside of the outer shaft 500. With no constraining force of the outer shaft 500, the gripping members 304 of gripping assembly 300 are in the fully deployed state as shown in Fig. 11B. Since the diameter of the gripping assembly 300 in the fully expanded state is greater than the diameter of the sealing member 102 of the implant 100, this movement causes the claws 304b to release the implant 100. Thus, the implant 100 is fully deployed state it at the desired position. Fig. 11A shows the configuration of the control element 450, the first locking member 604 and the second locking member 606 in the fully deployed state. Fig. 11B shows the gripping assembly 300 and the implant 100 in the fully deployed state.
[0079] At step 813, after the implant 100 is fully deployed, the control element 450 is pulled back to the proximal end 602a of the longitudinal slot 602 as shown in Fig. 12A. The gripping assembly 300 along with the inner shaft 400 retracts into the outer shaft 500 as shown in Fig. 12B. This retraction ensures that the gripping members 304 are completely enclosed within the outer shaft 500, preventing any interference during the withdrawal of the delivery system 200. The first locking member 604 is then returned to the first locked position 700a, securing the control element 450 and preventing accidental movement.
[0080] At step 815, the delivery system 200 is then carefully withdrawn from the patient’s body, completing the procedure.
[0081] The proposed implant presents several advantages over conventional septal defect closure devices. The implant, which is made of a self-healing material, offers a significant advancement in treating septal defects by providing immediate occlusion post-implantation. Unlike traditional metal or biodegradable occluders, the proposed implant enables access to future treatments by providing a passage to other medical instruments without structural harm to the implant, enhancing the patient outcome. The anchors of the implant provide a secure grip on the septum wall while effectively sealing the defect. The slots of the anchors enable easier penetration, reduce the deployment time. Further, the compressibility of the heads of the anchors due to the slots result in smaller holes in the septum wall, minimizing trauma and improving the outcome for the patients. Overall, the anchors enhance stability, reducing the risk of displacement and improving procedural success rates. Moreover, the implant is adaptable for both surgical and minimally invasive implantation, offering flexibility for medical professionals and simplifying procedural complexity. Its ability to accommodate a wider range of defect sizes allows for inventory optimization, minimizing the number of implants required for treatment. Additionally, the self-healing property ensures ease of deployment, enhances patient safety, and provides long-term benefits by allowing for future interventions if necessary.
[0082] The delivery system enhances procedural efficiency by reducing the number of required sizes of the delivery catheter to two, streamlining device selection and minimizing inventory. Its two-stage sliding mechanism ensures precise and controlled implant deployment while minimizing migration and septal tissue trauma. The delivery system has adaptability to accommodate various defect sizes, improving treatment versatility. An ergonomic handle provides enhanced user control, enabling faster and more efficient deployment. Additionally, the system maintains high biocompatibility and is compatible with MRI/CT imaging, ensuring seamless post-procedure diagnostics. The optimized design reduces catheter exchanges, enhancing patient safety and procedural success rates.
[0083] 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 implant (100) to occlude a septal defect, the implant (100) comprising:
a. a sealing member (102) comprising:
a. a first portion (102b) having a first thickness (W1);
b. a second portion (102c) surrounding the first portion (102b) and having a second thickness (W2) greater than the first thickness (W1) of the
c. first portion (102b); and
b. a plurality of anchors (104) extending from a distal face (102a) of the second portion (102c) to a distal end (100b) of the implant (100) and configured to penetrate through a septum wall (10), wherein a portion of each anchor (104) of the plurality of anchors (104) is configured to reside in the septum wall (10),
c. wherein the first portion (102b) and the second portion (102c) of the sealing member (102) are made of a self-healing, biocompatible material.
2. The implant (100) as claimed in claim 1, wherein each anchor (104) comprises:
a. a stem (104a) extending from the distal face (102a) of the second portion (102c), wherein a portion of the stem (104a) is configured to reside in the septum wall (10); and
b. a head (104b) extending from a distal end of the stem (104a) to a distal end (100b) of the implant (100), the head (104b) comprising a plurality of slots (104b1) provided circumferentially and extending from a proximal end of the head (104b) towards a distal end of the head (104b) for a partial length of the head (104b).
3. The implant (100) as claimed in claim 1, wherein a ratio (R) of the first thickness (W1) to the second thickness (W2) ranges between 0.3 and 0.7.
4. The implant (100) as claimed in claim 1, wherein a ratio (R) of the first thickness (W1) to the second thickness (W2) ranges between 0.4 and 0.6.
5. The implant (100) as claimed in claim 1, wherein a ratio (R) of the first thickness (W1) to the second thickness (W2) is 0.5.
6. The implant (100) as claimed in claim 1, wherein the self-healing, biocompatible material comprises silicone, polymers, polyether ether ketone (PEEK), expanded polytetrafluoroethylene (ePTFE), polyurethane (PU), polylactic acid (PLA), hydrogels, or combinations thereof.
7. The implant (100) as claimed in claim 1, wherein a proximal face of the first portion (102b) is in flush with a proximal face of the second portion (102c).
8. A delivery system (200) for delivering an implant (100), the delivery system (200) comprising:
a. an outer shaft (500);
b. an inner shaft (400) disposed within the outer shaft (500);
c. a gripping assembly (300) comprising a plurality of gripping members (304) coupled to the inner shaft (400) and configured to grip an implant (100);
d. a control element (450) coupled to the inner shaft (400) and configured to axially move the inner shaft (400) and trigger the gripping assembly (300) to be in one of: an undeployed state, a partially deployed state or a fully deployed state;
e. wherein in the undeployed state, the plurality of gripping members (304) is completely disposed inside the outer shaft (500);
f. wherein in a partially deployed state, the plurality of gripping members (304) is partially disposed inside the outer shaft (500) and partially disposed outside the outer shaft (500);
g. wherein in the deployed state, the plurality of gripping members (304) is completely disposed outside the outer shaft (500) to release the implant (100).
9. The delivery system (200) as claimed in claim 8, wherein each gripping member (304) comprises:
a. an elongated portion (304a) provided at a proximal end of the gripping member (304) and coupled to the inner shaft (400); and
b. a claw (304b) provided at a distal end of the gripping member (304) and configured to grip the implant (100);
c. wherein in the undeployed state, the elongated portions (304a) of the plurality of gripping portions (304) are configured to flex radially inward;
d. wherein in the partially deployed state, the elongated portions (304a) are configured to flex radially outward;
e. wherein in the fully deployed state, the elongated portions (304a) are configured to flex radially outward and make a pre-defined angle (A) with a longitudinal axis (B) of the gripping assembly (300) to release the implant (100) from the claw (304b) of the plurality of gripping members (304).
10. The delivery system (200) as claimed in claim 9, wherein the claw (304b) of each gripping member (304) comprises a slot (304b1) configured to receive a portion of the implant (100).
11. The delivery system (200) as claimed in claim 9, wherein the gripping assembly (300) comprises a coupling element (302) provided at a proximal end (300a) of the gripping assembly (300) and comprising an opening (302a) configured to receive and couple with a distal end (400b) of the inner shaft (400), wherein a proximal end of the elongated portions (304a) of the plurality of gripping members (304) are coupled to the coupling element (302).
12. The delivery system (200) as claimed in claim 8, wherein the control element (450) is disposed in a longitudinal slot (602) and is movable between a proximal end (602a) and a distal end (602b) of the longitudinal slot (602), wherein in response to the movement of the control element (450) towards the distal end (602b) of the longitudinal slot (602), the inner shaft (400) is configured to move axially in a distal direction;
a. wherein in the undeployed state, the control element (450) is positioned at the proximal end (602a) of the longitudinal slot (602);
b. wherein in the fully deployed state, the control element (450) is positioned at the distal end (602b) of the longitudinal slot (602);
c. wherein in the partially deployed state, the control element (450) is positioned at a first intermediate position located between the proximal end (602a) and the distal end (602b) of the longitudinal slot (602).
13. The delivery system (200) as claimed in claim 12, wherein the delivery system (200) comprises a first locking member (604) disposed within a first lateral groove (602c) extending laterally from the longitudinal slot (602), the first locking member (604) is movable in the first lateral groove (602c) between a first locked position (700a) and a first unlocked position (700b), wherein in the first locked position (700a), the first locking member (604) is configured to lock the control element (450) at the proximal end (602a) of the longitudinal slot (602).
14. The delivery system (200) as claimed in claim 13, wherein the longitudinal slot (602) comprises a first notch (608) aligned with the first lateral groove (602c) and configured to engage with the first locking member (604) when the first locking member (604) is disposed at the first locked position (700a).
15. The delivery system (200) as claimed in claim 12, wherein the delivery system (200) comprises a second locking member (606) disposed within a second lateral groove (602d) extending laterally from the longitudinal slot (602), the second locking member (606) is movable in the second lateral groove (602d) between a second locked position (700c) and a second unlocked position (700d), wherein in the second locked position (700c), the second locking member (606) is configured to lock the control element (450) at a first intermediate position.
16. The delivery system (200) as claimed in claim 15, wherein the longitudinal slot (602) comprises a second notch (610) aligned with the second lateral groove (602d) and configured to engage with the second locking member (606) when the second locking member (606) is disposed at the second locked position (700c).
17. The delivery system (200) as claimed in claim 12, wherein the control element (450) comprises a first portion (452) provided at a top end of the control element (450), a third portion (456) provided at a bottom end of the control element (450) and a second portion (454) extending between the first portion (452) and the third portion (456), wherein the second portion (454) is disposed in the longitudinal slot (602) and the third portion (456) resides within a cavity (600c) of a handle (600), wherein the longitudinal slot (602) is provided in the handle (600).
18. The delivery system (200) as claimed in claim 8, wherein the delivery system (200) comprises a handle (600) provided at a proximal end (200a) of the delivery system (200) and coupled to the outer shaft (500), the handle (600) comprising a channel (600d) extending from a distal end (600b) of the handle (600) to the cavity (600c) and configured to receive the inner shaft (400).