Abstract: TITLE OF INVENTION: VASCULAR FILTER An implantable vascular filter (100) includes a hub (120) and a frame (110). The frame (110) extends between a proximal end (100a) and a distal end (100b) of the filter (100). The frame (110) includes a plurality of units (101) of one or more struts arranged uniformly radially around the hub (120). Each unit (101) of the struts defines a head portion (111), a neck portion (112) and a leg portion (113). The head portion (111) forms a crown of the frame (110). The neck portion (112) is configured to bulge towards a medial side of the frame (110). The leg portion (113) defines a flare towards the distal end (100b) of the filter (100). The leg portion (113) includes two or more anchoring edges (130) disposed at a distal end of each of the struts of the leg portion (113). Fig. 2b
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:
VASCULAR FILTER
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 THE INVENTION
[001] The present invention relates to a device for filtration of blood clots within the human body. More specifically, the present invention relates to a device useful for the filtration of blood clots inside the Inferior Vena Cava (IVC).
BACKGROUND OF THE INVENTION
[002] Veins are the blood vessels that bring deoxygenated blood back to the heart. Arteries are blood vessels that carry oxygenated blood. The inferior vena cava is a large vein that carries the deoxygenated blood from the lower and middle body into the right atrium of the heart.
[003] Pulmonary embolism (PE) is one of the most common heart and blood vessel diseases in the world. Pulmonary embolism (PE) is a sudden blockage in a lung artery. It occurs when a blood clot dislodges from a vein in the body, travels through the bloodstream, and ends up in an artery in the lungs. The most common cause of pulmonary embolism is the breaking of a blood clot that is formed inside one of the deep veins of the thigh or lower leg. PE is a serious condition that can cause permanent damage to the lungs, low oxygen levels in the blood, and can also severely damage other organs of the body because of not getting enough oxygen. PE can be life-threatening and often lead to heart attack, stroke, pulmonary hypertension, and pulmonary infarction (lung tissue death).
[004] Treatments for pulmonary embolism (PE) include medicines like anticoagulants, or blood thinners which prevent the formation of new clots, and thrombolytics which can dissolve blood clots. Other treatment procedures include catheter-assisted thrombus removal and a vena cava filter. A vena cava filter is useful for patients that are allergic to blood thinners. This is a small metal device placed inside the inferior vena cava (IVC) and catches the blood clots before they travel to the lungs thus preventing pulmonary embolism.
[005] IVC filters known in the art suffer from shortcomings, such as incomplete or asymmetric deployment, filter migration, and/or tilting. Filter migration is defined as a change in the position of the filter from its deployed position by more than 2 cm. The IVC filter tends to migrate to the heart, pulmonary arteries, intrahepatic IVC, hepatic veins, renal veins, iliac veins, and superior vena cava. Tilting is the angulation of the filter by more than 15⁰ to the longitudinal axis of IVC. These may affect the overall efficiency of filtering the blood clots inside the IVC vein thereby not being able to prevent pulmonary embolism.
[006] Thus, there is a need for an improved blood filtration device which overcomes the aforementioned and other shortcomings associated with IVC filters known in the art.
SUMMARY OF THE INVENTION
[007] 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 merely 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.
[008] The present disclosure relates to an implantable vascular filter. The implantable vascular filter includes a hub and a frame. The frame extends between a proximal end and a distal end of the filter. The frame includes a plurality of units of one or more struts arranged uniformly radially around the hub. Each unit of the struts defines a head portion, a neck portion and a leg portion. The head portion forms a crown of the frame. The neck portion is configured to bulge towards a medial side of the frame. The leg portion defines a flare towards the distal end of the filter. The leg portion includes two or more anchoring edges disposed at a distal end of each of the struts of the leg portion.
BRIEF DESCRIPTION OF THE DRAWINGS
[009] The summary above as well as a detailed description of the illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, the 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.
[010] Fig.1 depicts a blood filter 100 implanted inside the inferior vena cava 10 in accordance with an embodiment of the present disclosure.
[011] Fig. 2a depicts a front view of a blood filter 100, in accordance with an embodiment of the present disclosure.
[012] Fig. 2b depicts an isometric view of a blood filter 100, in accordance with an embodiment of the present disclosure.
[013] Fig. 2c depicts a unit 101 of a blood filter 100, in accordance with an embodiment of the present disclosure.
[014] Fig. 3 depicts a method 200 of manufacturing the blood filter 100 in accordance with an embodiment of the present invention.
[015] Fig. 4 depicts a first step of implanting the blood filter 100 inside the inferior vena cava 10 in accordance with an embodiment of the present disclosure.
[016] Fig. 5 depicts a second step of implanting the blood filter 100 in expanded configuration inside the inferior vena cava 10 in accordance with an embodiment of the present disclosure.
[017] Fig. 6 depicts a third step of implanting the blood filter 100 inside the inferior vena cava 10 in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[018] 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.
[019] 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.
[020] 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.
[021] 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.
[022] In accordance with the present disclosure, a vascular filter (or filter) is disclosed. The filter may be implanted inside a vein for the filtration of blood clots. In an exemplary embodiment, the filter is implanted inside the inferior vena cava (IVC) to catch and break down the blood clots.
[023] The filter of the present disclosure is further configured to filter blood clots from the IVC in order to prevent the blood clots from traveling to the arteries of the lungs, thereby preventing pulmonary embolism.
[024] The filter of the present disclosure is implanted inside the inferior vena cava via a minimally invasive procedure using a transfemoral approach. The filter of the present disclosure has a design that is easy to deploy within the inferior vena cava. The filter of the present disclosure consists of one or more units which form an overall domed or pot-shaped head portion of the frame that allow easy flow and passage of blood while still trapping only the blood clots. Such a domed head portion may be particularly effective in capturing dislodged clots, and allowing an extended dwell time, allowing the clots to break down over time.
[025] The units include one or more struts. The hyperbolic curve-shaped structure of struts of the filter of the present disclosure provides adequate grip inside the inferior vena cava to catch and break down the blood clots. Further, the hyperbolic curve-shaped structure of the struts of the filter prevents tilting of the filter once implanted inside the targeted site.
[026] Further, the filter of the present disclosure includes anchoring edges towards the endpoints of the struts which help to fix the device firmly inside the inferior vena cava. Due to this, the filter does not migrate from its original position to the other parts of the human body once it is implanted inside the inferior vena cava.
[027] Now referring to figures, Fig. 1 depicts the inferior vena cava (IVC) 10. Blood clots may travel from the deep veins of the body, for example, the legs, to the IVC and the heart, and finally, to the arteries of the lungs of the patient where the clots may cause pulmonary embolism. The IVC may be the most appropriate location to place a filter 100 to capture dislodged blood clots. In an exemplary embodiment, as shown in Fig. 1, the filter 100 is implanted inside the IVC 10 to trap and break down the blood clots or thrombus to reduce the potential risk of thrombus migration from the IVC to the lungs of a patient’s body.
[028] Figs. 2a-2b depicts various configurations of the implantable vascular filter 100 hereinafter, the filter 100. The filter 100 has a proximal end 100a and a distal end 100b. The filter 100 includes a frame 110 and a hub 120. In an embodiment, the filter 100 is self-expandable. The filter 100 of the present disclosure is delivered inside the IVC in a crimped configuration using a transfemoral approach and is capable of attaining an expanded configuration from a crimped configuration post-deployment at the target site. The filter 100 facilitates precise filtration of blood clots inside the IVC thereby, preventing entry of the blood clots into the lungs of the patient.
[029] The filter 100 is radially symmetrical around the axis xx’. Further, the filter 100 is radially expandable away from the axis xx’ from the crimped configuration.
[030] The frame 110 extends between the proximal end 100a and the distal end 100b of the filter 100. The frame 110 may have a length ranging from 46 mm to 66 mm. In an embodiment, the length of the frame 110 is 58 mm.
[031] In an embodiment, the frame 110 is made of a plurality of units 101. An exemplary unit 101 of the frame 110 from the plurality of units 101 is depicted in Fig. 2c. Each unit 101 encompasses a vent within its boundaries defined by one or more struts. The plurality of units 101 is arranged radially around the hub 120 in a uniform manner. The arrangement of the units 101 in a pre-defined manner gives a shape to the frame 110. The number of units 101 in a frame 110 may depend on the need of the patient and the design of the filter 100. The number of units 101 may range from 3 to 10. In an embodiment, the number of units 101 is 5
[032] In the crimped configuration of the filter 100, the units 101 are constricted close to one another, and radially constricted towards axis xx’. The crimped configuration of the filter 100 is implemented when the filter 100 has to be navigated towards the targeted site inside the body. Once the filter 100 is positioned at the targeted site, the units 101 are released, thus attaining their expanded configuration and defining a gap between two adjacent units 101.
[033] Each unit of the plurality of units 101 is bound at the proximal end 100a and free at the distal end 100b of the filter 100. As stated above, each unit 101 is formed of one or more shape-set struts 150. The units 101 formed by the struts 150 are designed and arranged in such a way that the frame 110 defines a head portion 111, a neck portion 112 and a leg portion 113. The head portion 111, the neck portion 112 and the leg portion 113 may be substantially symmetrical about the axis xx’. In an embodiment, a single strut 150 may be used to manufacture one unit 101. For example, a unit 101 may be constructed using a wire forming process. The process includes cutting a predetermined length of a solid nitinol wire based on the dimension of the unit needed and shape setting the same. Alternately, multiple segments of a wire, each segment defining one strut 150, may be used to fabricate a unit 101.
[034] The struts of the head portion 111 are provided towards the proximal end 100a of the filter 100. The struts of the head portion 111 of the frame 110 may define a crown or a cap having a shape without limitation, spherical, cylindrical, conical, dome, square, and the like. In an exemplary embodiment, the frame 110 includes a dome-shaped head portion 111. The shape of the head portion 111 helps in trapping the blood clots to be broken down further. In an embodiment, the struts of the head portion 111 are provided with one or more threads to further connect with the hub 120.
[035] The struts of the neck portion 112 are situated between the head portion 111 and the leg portion 113. The struts of the neck portion 112 define a medial constriction towards the axis xx’ of the frame 110. In an embodiment, the struts of the neck portion 112 define a C-shaped medial constriction towards the axis xx’ of the frame 110. The shape of the neck portion 112 helps in enhancing the blood flow through the filter 100 and captures the blood clot in the filter 100.
[036] In an embodiment, the struts of the head portion 111 and the neck portion 112 together resemble a S-shape.
[037] The leg portion 113 is situated towards the distal end 100b of the filter 100. The struts of the leg portion 113 of the frame 110 may have a shape, such as, without limitation, linear, curve, stepped, arc, and the like. In an exemplary embodiment, the struts of the leg portion 113 are curved. The struts of the leg portion 113 define a hyperbolic curve. The curved shape of the leg portion 113 helps in better placement of the filter 100 and ensures adequate grip to the walls of the IVC 10. This prevents the filter 100 from tilting at the target site and also migrating into the blood streams in situations of heavy blood pressure. The struts of the leg portion 113 define a flare towards the distal end 100b of the filter 100. In an embodiment, the struts of the leg portion 113 are flared in an outward direction. The flare helps in preventing migration of the filter 100 and providing adequate grip inside the IVC 10.
[038] The leg portion 113 may define two or more anchoring edges 130. The two or more anchoring edges 130 are disposed at a distal end of the struts of the leg portion 113. The two or more anchoring edges 130 of the filter 100 point radially outward with respect to a central axis (xx’) of the filter 100. In an embodiment, struts of each leg portion 113 define two anchoring edges 130, although, the number of anchoring edges 130 may vary depending upon the needs of the patients and design of the filter 100. In an alternate embodiment, the struts of the leg portion 113 define multiple anchoring edges 130. The anchoring edges 130 help to securely fix the filter 100 at the target location i.e., inside the IVC 10 and prevent the migration of the filter 100 from its deployed position.
[039] The leg portion 113 further includes one or more V-shaped struts 131. The V-shaped struts 131 connect anchoring edges 130. Specifically, each V-shaped strut 131 connects two adjacent anchoring edges 130. This increases overall strength of the filter 100.
[040] Each of the plurality of struts 150 may have a pre-defined width ranging between 150 microns to 350 microns, and length between 44 mm to 64 mm. In an embodiment, the length and the width of the plurality of strut 150 is 55 mm and 250 microns respectively. The struts 150 may be made of a metal or a polymeric material. The metal may include, without limitation, stainless steel, nickel-titanium alloys, tantalum, cobalt-chromium alloys, magnesium alloys, titanium, and the like. The polymeric material may include, without limitation, polyethylene (PE), polyurethanes (PU), polyglycolic acid (PGA), polylactic acid (PLA), etc. In an embodiment, the struts 150 are made of Nitinol. Further, Nitinol is highly corrosion resistant, and exhibits good shape memory and flexibility that can be tailored to different shapes as per requirements.
[041] The hub 120 is provided towards the proximal end 100a of the filter 100. The hub 120 may be made up of biocompatible material, such as without limitation, stainless steel, nitinol, cobalt chromium, titanium, and the like. In an exemplary embodiment, the hub 120 is made up of stainless steel. In an embodiment, the hub 120 functions as a junction to attach the frame 110 and reposition the unit 101. The hub 120 also provides strength and support to the frame 110.
[042] In an embodiment, the proximal end of the plurality of units 101 are joined exclusively at the hub 120. The plurality of units 101 may be coupled to the hub 120 via a technique, such as, without limitation, laser welding, welding, soldering, brazing, etc. In an embodiment, the plurality of units 101 is coupled to the hub 120 using laser welding.
[043] The recapturing unit 140 is provided at the proximal end 100a of the filter 100. The recapturing unit 140 is coupled to the hub 120 via a technique such as, without limitation, laser welding, welding, soldering, brazing, etc. In an exemplary embodiment, the recapturing unit is coupled to the proximal end 100a of the filter 100 using laser welding. The recapturing unit 140 acts as a gripping structure to facilitate implantation and extraction of the filter 100. The recapturing unit 140 may be made of a material including, without limitation, stainless steel, nitinol, cobalt chromium, titanium, etc. In an embodiment, the recapturing unit 140 is made of stainless steel.
[044] Fig. 3 depicts an exemplary method 200 of manufacturing the filter 100. The method begins at step 201, where a tube raw material stock is laser-cut to form the struts 150 of the frame 110. The laser cutting is performed using a laser cutting machine. In an exemplary embodiment, the tube is a Nitinol tube having a thickness of 250 µm and a diameter of 2.4 mm. The outline structure obtained from the laser cutting process yields the frame 110 including the plurality of struts and the anchoring edges (as described above).
[045] Any known laser machining device, suitable for processing metals may be employed for step 201. For example, a CO2 laser, a fiber laser, a pulsed or a continuous wave laser, a gas assist laser etc. may be used for laser cutting. Gas assist may provide advantages such as cooling the workpiece, shielding to avoid oxidation, and improve cutting speed or efficiency such that a lower power may be used, resulting in less heating of the workpiece, and consequently lower risk of warping or other machining deformities. For example, nitrogen, oxygen, compressed air, inert gasses such as Argon or Helium, or any combination thereof, may be used as an assist gas.
[046] At step 203, the struts 150 obtained from step 201 may be subjected to grinding and honing. These two processes are performed to remove burs, other machining marks or deformities, and the unwanted particles from the tube, particularly at the laser-cut edges of the struts 150. The grinding and honing of the struts 150 may also remove any non-uniform surface imperfections thereby resulting in a smooth and thinner frame 110.
[047] At step 205, the struts 150 obtained are shape set to form the final shaped structure of the frame 110. In one embodiment, the tube may be formed using a die forming operation to obtain the structure of the frame 110.The die forming operation may include, for example, hydroforming, metal spinning, die pressing, and so forth, employing one or more suitable dies to form the final shape of the filter 100.
[048] In an alternate embodiment, the frame 110 may be formed using a wire forming process, from one or more lengths of solid wire stock. As per an exemplary embodiment, the entire frame 110 of the filter 100 may be formed using a single wire. Alternatively, each strut 150 of the frame 110 may be formed by a continuous length of wire.
[049] The wire forming process includes the manipulation of a straight or spooled length of the solid wire into the desired shape using a wire forming machine including hydraulic or mechanical manipulators for example benders, coilers, cutters, welders, crimpers, and rollers. The wire forming process may be performed using a wire forming machine, for instance a computer numerical controlled (CNC) forming machine. A CNC wire forming process may ensure high accuracy and high precision in dimensions. The wire forming process may also factor the elasticity of the nitinol wire, in order to meet the crimping parameters of the filter 100, as per requirement.
[050] At step 207, the frame may be blast finished to obtain a smooth, uniform surface over the tube, free from localized defects. Blast finishing may be performed by sand blasting, media blasting, or shot blasting. Blast finishing removes the oxidized layer or other contaminants (such as machining lubricants) from the struts 150, fill up the microcracks by localized compaction. Any suitable media may be used for blast finishing, for example, dry ice, sodium bicarbonate, or ceramics such as zirconia, silicon carbide, or alumina. The blast finishing media may be used dry or wet.
[051] At step 209, the frame 110 may be electro-polished to generate a micro-smooth, ultraclean, corrosion, and pathogen-resistant surface finish. Electro-polishing provides corrosion resistance by surface passivation. Further, electro-polishing helps in achieving the desired thickness and width of the struts 150.
[052] Further, the frame 110 is attached to the hub 120 via one or more threads present on the proximal end of the hub 120. The one or more threads of the hub 120 mate with the threads of the head portion 111.
[053] At step 211, the recapturing unit 140 may be coupled to the proximal end 100a of the filter 100 using techniques such as without limitation, laser welding, welding, soldering, brazing, etc. In an exemplary embodiment, the recapturing unit 140 is coupled to the proximal end 100a of the filter 100 using laser welding.
[054] It should be appreciated that the process steps described above in conjunction with Fig. 3 may be performed in an order different from the exemplary embodiment described above. For example, the forming process of step 205 may be performed first on the raw tube, followed by the laser cutting process of step 201, and subsequent steps. Such an order may ease the workpiece handling requirements such as clamping force, since an uncut tube is structurally much stronger than a laser machined frame.
[055] During a medical procedure, the filter 100 of the present disclosure may be implanted at the target site using a minimal invasive technique, such as trans-catheterization. Figs. 4, 5, and 6 illustrate the various steps of implanting the filter 100, according to one embodiment. In an exemplary embodiment, the trans-catheterization or transcatheter delivery of the filter 100 is carried out by using a delivery catheter or sheath 400, and a delivery shaft 401.
[056] Fig. 4 illustrates a first step, of manoeuvring the filter 100 to a targeted location. The filter 100 is pre-loaded in a delivery catheter/sheath 400. The filter 100 remains in the crimped position inside the delivery catheter 400. In an exemplary embodiment, a distal end 400b of a delivery shaft 401 (shown in Fig. 6) may be coupled to the proximal end 100a of the filter 100. In an exemplary embodiment, the hub 120 is provided towards the proximal end 100a of the frame 110. The hub 120 on the proximal end 100a of the frame 110 may include one or more threads. The one or more threads of the hub 120 are configured to mate with the corresponding one or more threads on the head portion of the delivery shaft 401 of the transcatheter 400.
[057] In yet another embodiment, the proximal end 100a of the filter 100 includes a protrusion. The protrusion may include one or more external threads, the one or more external threads are configured to mate with a corresponding one or more threads provided inside of the lumen towards the distal end 400b of the catheter 400. The screw-type mechanism ensures easy attachment/ detachment of the filter 100 from the delivery shaft 401 and prevents failure or slipping of the filter 100 during loading and deployment of the filter 100 at the targeted site. In various other embodiments, the delivery shaft 401 may be engaged with the hub 120 using other mechanisms such as a gripper mechanism.
[058] During the medical procedure, the delivery shaft 401 is loaded inside of the catheter 400, along with the filter 100. The catheter 400 is then introduced into the patient’s body via an appropriate vascular access point, e.g., through the transfemoral groin of a patient. Subsequently, the catheter 400 is navigated to the target site (i.e. Inferior Vena Cava) with the help of a guide wire (not shown). Fluoroscopic imaging techniques may be used to guide and monitor the advancement of the catheter 400 during the procedure.
[059] Fig. 5 illustrates the stage when the catheter is positioned at the implant target site. Once the catheter 400 reaches the target site i.e. Inferior Vena Cava, the membrane sheath is withdrawn. The withdrawal of the membrane sheath causes the filter 100 to emerge out of the catheter 400, and radially self-expand, thus causing the anchoring edges 130 to engage with the walls of the IVC 10. The filter 100 is now fixed in position at the target site.
[060] Fig. 6 illustrates the final stage of implanting, where the implanting tools are withdrawn. The filter 100 is detached from the delivery shaft 401 and it self-expands to its original configuration. The filter 100 may be implanted at the target site i.e. Inferior Vena Cava (IVC) by unscrewing the distal end of the delivery shaft 401 (as shown in Fig. 6). Once the filter 100 is positioned inside the inferior vena cava, the catheter 400 and the delivery shaft 401 is manually recaptured (as shown in Fig. 6).
[061] 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 implantable vascular filter (100) comprising:
a hub (120); and
a frame (110) extending between a proximal end 100a and a distal end 100b of the filter 100, the frame (110) including a plurality of units (101) arranged uniformly radially around the hub (120),
wherein each unit is made of two or more struts (150); and
wherein each unit (101) of the struts comprises:
a head portion (111) defining a crown of the frame (110),
a neck portion (112) defining a medial constriction towards a central axis (xx’) of the frame (110)
a leg portion (113), defining a flare towards the distal end 100b of the filter; and
two or more anchoring edges (130) disposed at a distal end of each of the strut of the leg portion (113).
2. The implantable vascular filter (100) as claimed in claim 1, further comprising a recapturing unit (140) coupled to the hub (120), the recapturing unit (140) configured to provide a gripping structure to facilitate implanting and extraction of the implantable vascular filter (100).
3. The implantable vascular filter (100) as claimed in claim 1, wherein each of the plurality of units (101) are joined exclusively at the hub (120).
4. The implantable vascular filter (100) as claimed in claim 1, wherein the units (101) are laser welded to the hub (120).
5. The implantable vascular filter (100) as claimed in claim 1, wherein the frame (110) is self-expandable and capable of attaining an expanded configuration from a crimped configuration post-deployment.
6. The implantable vascular filter (100) as claimed in claim 1, wherein the struts (150) are constructed from one of a metal or a polymer.
7. The implantable vascular filter (100) as claimed in claim 1, wherein the head portion (111) defines a crown or a cap having a shape including one of spherical, cylindrical, conical, dome, and square.
8. The implantable vascular filter (100) as claimed in claim 1, wherein the neck portion (112) include C-shaped bulge.
9. The implantable vascular filter (100) as claimed in claim 1, wherein the leg portion (113) includes an outward flare towards the distal end 100b of the filter.
10. The implantable vascular filter (100) as claimed in claim 1, wherein the leg portion (113) includes one or more V-shaped struts (131) that connect the anchoring edges 130.
11. The implantable vascular filter (100) as claimed in claim 1, wherein the leg portion (113) comprises a hyperbolic curvature with respect to a central axis (xx’) of the filter (100).
12. The implantable vascular filter (100) as claimed in claim 1, wherein the two or more anchoring edges (130) point radially outward with respect to a central axis (xx’) of the filter (100) from a distal end of each of the strut (150).
| # | Name | Date |
|---|---|---|
| 1 | 202421073483-STATEMENT OF UNDERTAKING (FORM 3) [28-09-2024(online)].pdf | 2024-09-28 |
| 2 | 202421073483-REQUEST FOR EXAMINATION (FORM-18) [28-09-2024(online)].pdf | 2024-09-28 |
| 3 | 202421073483-REQUEST FOR EARLY PUBLICATION(FORM-9) [28-09-2024(online)].pdf | 2024-09-28 |
| 4 | 202421073483-FORM-9 [28-09-2024(online)].pdf | 2024-09-28 |
| 5 | 202421073483-FORM FOR SMALL ENTITY(FORM-28) [28-09-2024(online)].pdf | 2024-09-28 |
| 6 | 202421073483-FORM FOR SMALL ENTITY [28-09-2024(online)].pdf | 2024-09-28 |
| 7 | 202421073483-FORM 18 [28-09-2024(online)].pdf | 2024-09-28 |
| 8 | 202421073483-FORM 1 [28-09-2024(online)].pdf | 2024-09-28 |
| 9 | 202421073483-FIGURE OF ABSTRACT [28-09-2024(online)].pdf | 2024-09-28 |
| 10 | 202421073483-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [28-09-2024(online)].pdf | 2024-09-28 |
| 11 | 202421073483-EVIDENCE FOR REGISTRATION UNDER SSI [28-09-2024(online)].pdf | 2024-09-28 |
| 12 | 202421073483-DRAWINGS [28-09-2024(online)].pdf | 2024-09-28 |
| 13 | 202421073483-DECLARATION OF INVENTORSHIP (FORM 5) [28-09-2024(online)].pdf | 2024-09-28 |
| 14 | 202421073483-COMPLETE SPECIFICATION [28-09-2024(online)].pdf | 2024-09-28 |
| 15 | 202421073483-FORM-26 [16-10-2024(online)].pdf | 2024-10-16 |
| 16 | Abstract.jpg | 2024-11-05 |
| 17 | 202421073483-Proof of Right [28-11-2024(online)].pdf | 2024-11-28 |
| 18 | 202421073483-FORM28 [25-09-2025(online)].pdf | 2025-09-25 |
| 19 | 202421073483-Form 1 (Submitted on date of filing) [25-09-2025(online)].pdf | 2025-09-25 |
| 20 | 202421073483-Covering Letter [25-09-2025(online)].pdf | 2025-09-25 |
| 21 | 202421073483-CERTIFIED COPIES TRANSMISSION TO IB [25-09-2025(online)].pdf | 2025-09-25 |