Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
  • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
  • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
  • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
  • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
  • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
  • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
  • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
  • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
  • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
  • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
  • A61B17/12177—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00526—Methods of manufacturing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00831—Material properties
  • A61B2017/0084—Material properties low friction
  • A61B2017/00845—Material properties low friction of moving parts with respect to each other
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00831—Material properties
  • A61B2017/00867—Material properties shape memory effect
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00831—Material properties
  • A61B2017/00942—Material properties hydrophilic
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
  • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
  • A61B2017/1205—Introduction devices
  • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
  • A61B2017/12095—Threaded connection
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
  • A61B2090/3966—Radiopaque markers visible in an X-ray image

Definitions

• the present invention relates to a medical device. More specifically, the present invention relates to an embolization device for blocking a blood vessel.
• Embolization corresponds to lodging of an embolus within a bloodstream. Embolization may be of natural origin or may be induced artificially as a treatment. Artificially induced or therapeutic embolization is performed as a hemostatic treatment for bleeding or as a treatment for some types of cancer by deliberately blocking blood vessels to starve the tumor cells.
• An embolization device is a bio-medical device that creates an occlusion in the vasculature to obstruct the pathway of blood flow.
• the embolization device fits within a targeted blood vessel and totally cuts off the pathway of blood flow thereby helping to treat various conditions including aneurysm, left atrial appendage, atrial septal defect, fistulas, patent foramen ovule, patent ductus arteriosus vessel shutdown or occlusive purposes in the peripheral vasculature.
• the device of this publication takes a lot of time to completely cut-off the blood flow at the implantation site thereby failing to provide instant hemostatic treatment to a patient. Further, such a device is also associated with issues relating to positional controllability as owing to the structure of the device, an operator does not have enough grip of the device at the time of implantation.
• embolization devices having multiple-lobes are also conventionally known.
• the embolization devices disclosed in patent publications US 10,624,619 and US 8,313,505 include multi-layered braided formation having a dual lobe structure.
• the dual lobe structure is in the form of dumbbell shape having two similar parts at both proximal and distal ends that expand circumferentially.
• the presence of lobes having same shapes as included in the devices of the aforesaid publications is associated with various challenges. The most crucial one being incapacity to completely cut-off the blood flow at the implantation site and high chances of migration of the device leading to cardiac failure and pulmonary vascular disease.
• the present invention relates to an embolization device (or device).
• the device includes a binary lobe structure having a proximal lobe and a distal lobe connected by a bridge is disclosed.
• the proximal lobe has a braided mesh structure with a gradually increasing diameter from a first proximal end to a first distal end (or gradually decreasing diameter from a first distal end to a first proximal end.
• the braided mesh structure is made from a plurality of wires and includes narrow pores to completely cut-off blood supply at an implantation site.
• the distal lobe is a braided mesh structure that extends from a second proximal end to a second distal end.
• the second distal end has a concave configuration which reduces overall length of the device thereby enhancing applicability of the device to varied implantation sites.
• the distal lobe includes a larger surface area than the proximal lobe thereby inhibiting chances of migration of the device and recanalization of the vessel.
• Fig. la depicts an embolization device 100 in delivery configuration in accordance with an embodiment of the present invention.
• Fig. lb depicts the embolization device 100 in deployed configuration in accordance with an embodiment of the present invention.
• Fig. 2 depicts the embolization device 100 in accordance with an embodiment of the present invention.
• Fig. 2a depicts a distal portion of the embolization device 100 in accordance with an embodiment of the present invention.
• Fig. 2b shows a jacket 105 of the embolization device 100 in accordance with an embodiment of the present invention.
• FIG. 3 shows the embolization device 100 connected to a delivery wire 'w' and a delivery catheter 200 in accordance with an embodiment of the present invention.
• Fig. 3a illustrates the delivery wire 'w' in accordance with an embodiment of the present invention.
• Fig. 3b shows the delivery wire 'w' in accordance with an embodiment of the present invention.
• Fig. 4 indicates a process for manufacturing the embolization device 100 in accordance with an embodiment of the present invention.
• Fig. 4a depicts a mold 300 used for shape setting in accordance with an embodiment of the present invention.
• the present invention discloses an embolization device that may be implanted at an implantation site in the form of a vessel segment located within a blood vessel in a patient's body.
• the embolization device of the present invention helps to obstruct pathway of blood flow at the implantation site thereby treating a pre-defined vascular defect.
• the embolization device of the present invention is capable of effectively treating arterial venous malformation, aneurysms, fistulas and other vascular defects.
• the embolization device of the present invention is a self-expandable device having two lobes i.e. a proximal lobe and a distal lobe disposed towards a proximal end and a distal end of the device, respectively.
• the proximal end of the device corresponds to the end that extends away from an operator while the distal end corresponds to the end positioned towards the operator and attached to a delivery wire.
• proximal and the distal lobes are separated by a bridge.
• the proximal and the distal lobes are two distinct structures that confer flexibility and infrangibility during post-deployment and/or pre-deployment process.
• the embolization device is implanted in such a way that the proximal lobe faces the blood flow pathway i.e., positioned against the blood flow.
• the distal lobe faces away from the blood flow pathway i.e., positioned along the blood flow. Therefore, the proximal lobe helps to promote early embolization and the distal lobe helps to reduce migration of the embolization device from the implantation site and supports the device during as well as after implantation.
• Each of the proximal and the distal lobes includes a braided mesh structure.
• the mesh structures of the proximal and distal lobes include a pre-defined wire density and wire diameter to impart flexibility to the device and also allow the device to be easily pushed with required radial strength during and after the implantation.
• the proximal lobe includes a conical structure made of a dense mesh structure with gradually increasing diameter and pore size. Densification of the braided mesh structure of the proximal lobe leads to reduced porosity which helps to completely shut-off the pathway of blood at the implantation site.
• the mesh structure of the distal lobe is cylindrical in shape and helps to achieve better engagement with the vessel segment at the implantation site, thereby minimizing the possibility of migration of the device from the implantation site.
• a polymer membrane is disposed inside the distal lobe which provides rapid embolization as compared to conventional systems.
• the polymer membrane helps to reduce and mitigate any chance of blood flow remaining after occlusion by the proximal lobe.
• the embolization device has two or more radiopaque markers on both lobes that help in positioning and observation of the device during and after deployment procedure.
• the embolization device of the present invention includes more surface contact area than the conventional systems which provides more grip of the embolization device at the time of implantation hence, overcoming the issues related to positional controllability with improved flexibility and controlled delivery.
• the embolization device can be delivered using a small French size of the delivery catheter (5 to 9 Fr) thereby eliminating existing issues of applicability of the embolization devices in infants or limited vessels.
• the embolization device of the present invention is constructed using a pre-defined method that provides adequate mechanical properties to the embolization device such as higher flexibility, kink resistance, low crimp profile, easy deployment, leak proof, etc.
• FIGs. la-lb and 2 disclose an embolization device 100 (or device 100) of the present invention.
• the embolization device 100 is a self-expandable device having a delivery configuration (Fig. la) and a deployed configuration (Fig. lb).
• the delivery configuration corresponds to a configuration in which the embolization device 100 is in a compressed state for delivery at an implantation site. In the compressed state, the embolization device 100 is in an almost linear configuration and disposed inside a delivery catheter 200 as shown in Fig. la.
• the deployed configuration corresponds to a configuration in which the embolization device 100 is in an expanded state and implanted at the implantation site.
• the embolization device 100 expands from the almost linear configuration to a three-dimensional expanded configuration as illustrated in Fig. lb.
• the embolization device 100 in deployed configuration blocks/restricts the flow of blood through the blood vessel at the implantation site.
• the blood vessel of the implantation site may include a peripheral artery, a pulmonary artery, a splenic artery, a portal vein, an internal iliac artery, an arterio-venous malfunctions, an arterio-venous fistula, etc.
• the embolization device 100 is deployed at the implantation site such that a longitudinal axis of the embolization device 100 coincides with an axis of a vessel segment of the blood vessel in which the embolization device 100 is being inserted.
• the embolization device 100 In order to strongly engage a lumen of the vessel segment of the blood vessel at the implantation site, the embolization device 100 includes a maximum expanded diameter that is slightly more (approximately 30 to 50 %) than the diameter of the lumen of the vessel segment of the blood vessel at the implantation site. Such selection of the maximum expanded diameter of the embolization device 100 helps to position the embolization device 100 securely against the lumen of the vessel segment of the implantation site. At the same time, the maximum expanded diameter of the device 100 so optimized does not cause any damage to an inner lining of the vessel or does not produce any bulge at an outer lining of the vessel.
• the embolization device 100 is desirably longer along its axis than its maximum expanded diameter as shown in FIG. lb. These dimensions of the device 100 substantially prevent the embolization device 100 from turning within the lumen at any angle with respect to the longitudinal axis thereby preventing the embolization device 100 from dislodgement along the vessel segment of the implantation site. The inability of the embolization device 100 to turn over helps to keep the embolization device 100 deployed precisely at the implantation site.
• the embolization device 100 engages the lumen of the vessel segment of the implantation site at two spaced apart locations. The said positioning is a resultant of the structure of the device 100.
• the embolization device 100 extends from a proximal end 100a to a distal end 100b of the device 100 thus, defining the longitudinal axis 'L' of the embolization device 100.
• the embolization device 100 includes various components that are aligned with the longitudinal axis 'L'.
• the embolization device 100 may include one or more of, a body 101, a proximal tube 103 and a distal tube (not shown) covered with a jacket 105.
• the body 101 of the embolization device 100 is in the form of a hollow structure defined by at least two lobes and a bridge 101c.
• Each of the lobes of the present invention is in the form of a braided mesh structure made of a plurality of wires.
• the braided mesh structure significantly increases the density of wires thereby reducing stiffness in the embolization device 100 and confers an ability to attain a low outer diameter whenever the embolization device 100 is longitudinally stretched.
• the mesh structures of the lobes include a pre-defined wire density and wire diameter that is selected to impart flexibility to the device 100 and also allow the device 100 to be easily pushed with required radial strength during and after the implantation.
• the mesh structures of the lobes may be formed by a bio-compatible and/or biodegradable material such as, without limitation, nitinol, poly-L-lactide (PLLA), etc.
• the mesh structures of the lobes are made of nitinol.
• the lobes may be structurally (i.e., shape and dimensions) same or different from each other. In an embodiment, the lobes are distinct, different from each other.
• the embolization device 100 includes a binary lobe structure having a proximal lobe 101a and a distal lobe 101b.
• the proximal lobe 101a is disposed at the proximal end 100a of the device 100 while the distal lobe 101b is disposed at the distal end 100b of the device 100.
• the proximal and distal lobes 101a and 101b, respectively, have different shapes and dimensions.
• the aforesaid binary lobe structure provides flexibility and mechanical strength to the embolization device 100 which effectively resists flow of blood inside a bulged capillary vessel of the implantation site. Owing to the presence of a binary lobe structure having distinct shape and dimensions, the issues relating to migration and complete cut-off of the blood flow are individually addressed via each of the two lobes (described below in detail).
• the proximal lobe 101a includes a conical shaped braided mesh structure extending from a first proximal end al to a first distal end a2. It should be noted that though the present invention is explained by way of a conical proximal lobe 101a, the possibility of other shapes such as spherical, concave, flattened oval, etc., is also within the scope of the present invention.
• the conical shape of the proximal lobe 101a resists the blood flow inside the blood vessel of the implantation site and flips the blood to another capillary vessel.
• the proximal lobe 101a Owing to the conical shape, the proximal lobe 101a includes gradually decreasing diameter from the first distal end a2 to the first proximal end al (or gradually increasing diameter from the first proximal end al to the first distal end a2). In an embodiment, the diameter of the proximal lobe 101a may range between 4 mm to 20 mm. The proximal lobe 101a includes a predefined length ranging between 4 mm to 9 mm.
• the mesh structure of the proximal lobe 101a may be made from a plurality of braided wires in an arrangement of coil formation.
• the proximal lobe 101a is made up of multiple layers of braided wires that result in formation of narrow pores of variable sizes.
• the pore size of the braided mesh structure may gradually decrease from the first distal end a2 to the first proximal end al and may range between 1-200 microns.
• the presence of narrow pores of variable sizes helps to shunt blood to another capillary vessel to completely cut-off blood supply at the implantation site and also prevents dislodging of the embolization device 100.
• the narrow pores of the proximal lobe 101a resist blood flow and improve filter property of the embolization device 100. Further, the narrow pores of the proximal lobe 101a help to create a wall against the forces created by the blood flow at the implantation site.
• the first proximal end al may be positioned adjacent to the proximal tube 103 that marks the proximal end 100a of the device 100.
• the first distal end a2 may be placed adjacent to the bridge 101c facing the distal lobe 101b.
• the distal lobe 101b has a cylindrical shaped braided mesh structure.
• a distal lobe 101b of other shapes such as spherical, concave, flattened oval, etc., is also within the scope of the present invention.
• the cylindrical shape of the distal lobe 101b allows the embolization device 100 to properly connect to the lumen of the vessel segment at the implantation site and also absorbs forces which are created by the proximal end 100a of the embolization device 100.
• the distal lobe 101b has a larger surface area than the proximal lobe 101a. Owing to the larger surface area of the distal lobe 101b, the embolization device 100 is able to fit well within the vessel segment of the implantation site thereby inhibiting the chances of migration and recanalization of the embolization device 100.
• the distal lobe 101b may include a uniform diameter and a pre-defined length.
• the diameter of the distal lobe 101b may range between 4 mm to 20 mm.
• the distal lobe 101b may be expandable upto 4 mm to 9 mm.
• the length of the distal lobe 101b may be equal to or slightly more than the length of the proximal lobe 101a.
• the length of the distal lobe 101b may range between 4 mm to 9 mm.
• the nearly equal lengths of both the proximal lobe 101a and the distal lobe 101b facilitate easy molding of the device 100 at the time of manufacturing of the device 100.
• the distal lobe 101b extends from a second proximal end bl to a second distal end b2.
• the second proximal end bl is placed adjacent to the bridge 101c and faces the first distal end a2 of the proximal lobe 101a.
• the second distal end b2 of the distal lobe 101b is placed adjacent to the jacket 105.
• the second proximal end bl is flat while the second distal end b2 of the distal lobe 101b includes a cupped or concave configuration.
• the cupped or concave configuration of the second distal end b2 helps in reducing overall length of the device 100 thereby providing a larger range of blood vessels in which the device 100 can be implanted as the device 100 can be easily implanted at the edge of the blood vessel.
• the distal lobe 101b at the second distal end b2 includes a dip with a depth 'd' ranging between 0.1 mm to 2 mm.
• the distal lobe 101b may house a flexible membrane (not shown).
• the flexible membrane may help to initiate the endothelialization process for embolization and complete (full) embolization of blood flow.
• the flexible membrane may be made of polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), polyurethanes, metallic materials, extracellular matrix, synthetic bioabsorbable polymeric scaffolds, etc.).
• PET polyethylene terephthalate
• ePTFE expanded polytetrafluoroethylene
• polyurethanes metallic materials
• extracellular matrix extracellular matrix
• synthetic bioabsorbable polymeric scaffolds etc.
• the dimensions of the flexible membrane may be dependent upon the dimensions of the distal lobe 101b.
• the diameter of the flexible membrane is same as the diameter of the distal lobe 101b.
• the flexible membrane may include a pre-defined thickness ranging between 10-150 pm.
• the weight of flexible membrane may range between 10 GSM to 40 GSM.
• the flexible membrane may be capable of expansion and contraction depending upon the configuration of the embolization device 100. For example, as the embolization device 100 expands from the delivery configuration to the deployed configuration, the flexible membrane also tends to expand. In an embodiment, the flexible membrane expands in a direction that is non-perpendicular to the longitudinal axis 'L' of the embolization device 100. In an alternate embodiment, the flexible membrane expands circularly, which is substantially perpendicular to the longitudinal axis 'L' of the embolization device 100.
• the distance separating the above-described proximal and distal lobes 101a, 101b may vary depending upon the size of the blood vessel (implantation site) where the embolization device 100 is to be deployed.
• one or more radiopaque markers may be placed either on the proximal and/or distal lobes 101a, 101b to help a physician orient the embolization device 100 efficiently.
• the radiopaque markers may be in the form of radiopaque platinum wires or platinum iridium markers attached to the mesh structures of the proximal/distal lobes 101a, 101b in such manner that the radiopaque markers do not impede braid expansion or contraction.
• Other materials such as stainless steel, nitinol, or tantalum may also be used.
• the above described proximal and distal lobes 101a, 101b are connected using the bridge 101c.
• the bridge 101c extends from the first distal end a2 of the proximal lobe 101a to the second proximal end bl of the distal lobe 101b.
• the bridge 101c is in the form of a short cylindrical section as shown in FIG. 2.
• other shapes and structures of the bridge 101c are also within the scope of the present invention.
• the bridge 101c plays a major role in contraction and expansion of the embolization device 100 and also imparts mechanical strength and flexibility to the proximal and distal lobes 101a, 101b.
• the bridge 101c helps to relieve pressure at the time of loading the embolization device 100 inside a loader.
• the bridge 101c provided vacant time during loading, which helps in expansion and contraction of the device 100 during loading and unloading, thus, reducing manual effort of loading.
• the proximal tube 103 is provided at the proximal end 100a of the embolization device 100.
• the proximal tube 103 helps to hold and secure/seal the free ends of the braided mesh structure of the proximal lobe 101a that are formed at the time of braiding.
• the proximal tube 103 and the distal tube are useful to prevent the free ends of the braided mesh structure from unraveling at either end of the body 101, thus, maintaining the shape of the body 101.
• the proximal tube 103 may be made of radiopaque material such as stainless steel (SS316L grade), nitinol, platinum, platinum-iridium, tantalum. In an embodiment, the proximal tube 103 is made of SS316L. The proximal tube 103 also works as a marker during surgery to identify the position of the device 100 during fluoroscopy.
• the proximal tube 103 includes pre-defined shape and dimensions.
• the cross-section shape of the proximal tube 103 may be circular, polygonal, etc. In an embodiment, the proximal tube 103 includes a cylindrical shape having a circular crosssection. The dimensions of the proximal tube 103 may depend upon the number of wires and diameters of each wire that is used in the device 100.
• the distal tube may be structurally (including shape and dimensions) and functionally same as the proximal tube 103 and hence, helps to hold and secure/seal the free ends of the of the braided mesh structure of the distal lobe 101b that are formed at the time of braiding.
• the distal tube may also be made of radiopaque material such as stainless steel, nitinol, platinum, platinum-iridium, tantalum.
• the distal tube is made of SS316L.
• the distal tube (not visible in figures) is covered with the jacket 105.
• the proximal tube 103 and distal tube may have inner diameter 0.8 mm to 1.2 mm and outer diameter 1.0 mm to 1.5 mm while length 0.8 mm to 1 mm.
• the jacket 105 is provided with the distal tube to help in attachment of the device 100 with the delivery wire 'w' for delivery and deployment procedure.
• the jacket 105 may be in the form of a cap and is welded or crimped over the distal tube. However, other structural embodiments of the jacket 105 are also within the scope of the present invention.
• FIG. 2b depicts an exemplary structure of the jacket 105.
• the jacket 105 includes a uniform outer surface 105a and an indented inner surface 105b.
• the indented inner surface 105b of the jacket 105 defines a first cavity 5bl and a second cavity 5b2.
• the first cavity 5bl is structured to fit over the distal tube.
• the second cavity 5b2 is used for engaging the delivery wire 'w' via a delivery wire screw (202 shown in FIGs. 3 and 3b).
• the second cavity 5b2 includes threaded walls to engage the delivery wire screw 202 (described below in detail).
• the dimensions of the first cavity 5bl may be dependent upon the dimensions of the distal tube while the dimensions of the second cavity 5b2 may be dependent upon the dimensions of the delivery wire screw 202.
• the foregoing embolization device 100 may be delivered using the delivery catheter 200 and the delivery wire 'w'.
• the delivery catheter 200 navigates the embolization device 100 through the vasculature of the patient's body for delivery at the implantation site.
• the delivery catheter 200 may be operated using a remote which is located outside the patient's body.
• other means of operation of the delivery catheter 200 are also within the scope of the present invention.
• the delivery wire 'w' helps to guide the embolization device 100 and the delivery catheter 200 through the vasculature to arrive at the implantation site.
• the delivery wire 'w' is connected to the device 100 via the delivery wire screw 202 as shown in FIG. 3.
• the delivery wire 'w' may be in the form of an elongate flexible metal shaft or a braided tube.
• the delivery wire 'w' may be made of nitinol, medical grade low alloy stainless steel or any other biocompatible metals.
• the delivery wire 'w' is in the form of a distally tapered nitinol wire as shown in FIG. 3a.
• the delivery wire 'w' may be provided with a hydrophilic coating 'He'.
• a hydrophilic coating 'He' provides extra lubricity to the delivery wire 'w' which helps minimizing flow resistance during delivery of the device 100.
• the hydrophilic coating 'He' of polytetrafluoroethylene (PTFE) or teflon is provided over the delivery wire 'w'. This coating may be applied over the whole length of the delivery wire 'w' or a part of it. For example, for the purpose of retaining flexibility and ease of handling, a tapered portion 'wl' of the delivery wire 'w' is not coated with any hydrophilic coating 'He' as evident from FIG. 3a.
• the tapered portion 'wl' of the delivery wire 'w' is structured to connect with the delivery wire screw 202.
• FIG. 3b An exemplary structure of the delivery wire screw 202 (or screw 202) is shown in FIG. 3b.
• the screw 202 is in the form of a hollow cap 202a having an extension 202b.
• the hollow cap 202a may house the tapered portion 'wl' of the delivery wire 'w'.
• the tapered portion 'wl' of the delivery wire 'w' is welded or crimped within the hollow cap 202a of the screw 202.
• the extension 202b is connected to the second cavity 5b2 of the jacket 105.
• the extension 202b are threaded to engage with the second cavity 5b2 via a threaded connection. Such a threaded connection allows easy engagement and disengagement of the embolization device 100 with the delivery wire 'w'.
• the delivery catheter 200 housing the delivery wire 'w' connected with the device 100 is advanced to the implantation site through a sheath.
• the delivery catheter 200 includes a provision for repositioning the embolization device 100 if it is determined that the embolization device 100 is not properly positioned within the shunt.
• the delivery catheter 200 retains the device 100 till the device 100 is properly positioned at the implantation site.
• the delivery wire 'w' may be rotated about its axis to unscrew the embolization device 100 from the delivery wire screw 202.
• the above-described embolization device 100 is formed using a pre-defined methodology 400 as illustrated in FIG. 4.
• the body 101 of the embolization device 100 is formed via filament braiding.
• the wires may be made of a shape memory material such as nitinol, a nickel titanium alloy.
• the number of braided wires may range from 32 to 144, depending upon the desired characteristics of the particular device 100.
• 72 nitinol wires are braided at an angle of 105 to 145 degrees.
• the diameter of the wires may range from 0.068-0.101 mm. In an embodiment, the diameter of the wires is 35 microns to 120 microns.
• Each braid includes two sets of essentially parallel helical strands with one set of strands having clockwise direction and the other set of strands having an anti-clockwise direction.
• a typical pitch angle may range from 30-70 degrees from the longitudinal axis of the braided tube (as braided relaxed tube prior to heat treatment). It should be noted that the pitch and the wire diameter are all variables that can be altered to change the shape and characteristics of the embolization device 100.
• a braided nitinol tube is generated using a braiding machine and is converted into spindle design in such a way that it reduces extra pressure on the wires.
• the braided tube is annealed and heat set in cylindrical shape at 505 °C for 5 minutes.
• the annealing performed at step 403 helps to obtain the device 100 having the desired shape.
• the annealed tube is molded and shape set.
• a mold 300 is used in order to shape set the braided tube.
• the mold 300 used in the present invention is shown in FIG. 4a.
• the tube is placed over the mold 300 and heated at a pre-defined temperature for a pre-defined time.
• the parameters for shape setting may be dependent upon the material of the wires used. For example, for nitinol braided tube, the parameters are 505°C temperature and 5 minutes time duration.
• a molded tube is obtained and is removed from contact with the mold surface.
• the molded tube corresponds to the body 101 of the embolization device 100 having the proximal lobe 101a and the distal lobe 101b connected by the bridge 101c.
• the body 101 formed at step 405 is mounted over the proximal tube 103 and the distal tube.
• the diameter of the proximal tube 103 and the distal tube include some clearance. The clearance is maintained in a range of 10-30% of the diameter of the proximal tube 103 and the distal tube.
• Each of the proximal tube 103 and distal tube includes an outer diameter which is dependent on the size of the delivery catheter 200. To avoid scratching of an inner surface of the delivery catheter 200 by the embolization device 100, the inner diameter of the delivery catheter 200 is more than the outer diameter of the proximal tube 103 and the distal tube.
• the body 101 is coupled to the proximal tube 103 and the distal tube in a pre-defined manner.
• the proximal tube 103 and the distal tube is manually mounted using forceps or an equivalent component.
• the ends of the proximal and distal lobes 101a and 101b may be encapsulated by a para film or a similar material.
• the loose ends of the proximal and the distal lobes 101a and 101b are sealed using laser welding, spot welding or crimping.
• the distal tube towards the distal lobe 101b is provided with the jacket 105 and welded thereof.
• the flexible membrane is stitched to the distal lobe 101b.
• the polymeric fibers in the flexible membrane may include monofilament or multifilament yarns ranging from about 50-300 denier.
• the individual filaments may range from about 0.25-10 denier.
• a wax finished polyester suture is used to stitch the flexible membrane.
• the suture tightly bonds the flexible membrane over the embolization device 100.
• the size of the suture may range between 3/0 to 5/0 USP.
• the flexible membrane is stitched using two over two pattern of stitching.
• the embolization device 100 is formed.
• the embolization device 100 is packaged and sterilized followed by secondary and final packaging.
• the embolization device 100 is sterilized using ETO sterilization.

Landscapes

• Health & Medical Sciences (AREA)
• Surgery (AREA)
• Life Sciences & Earth Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Molecular Biology (AREA)
• Vascular Medicine (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Reproductive Health (AREA)
• Medical Informatics (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Media Introduction/Drainage Providing Device (AREA)
• Surgical Instruments (AREA)

Priority Applications (2)

Applications Claiming Priority (2)

Publications (1)

Family

ID=89984759

Family Applications (1)

Country Status (4)

Families Citing this family (1)

Citations (7)

Family Cites Families (2)

• 2023
  • 2023-02-06 IN IN202321007367A patent/IN202321007367A/en unknown
• 2024
  • 2024-01-17 JP JP2025544942A patent/JP2026504461A/ja active Pending
  • 2024-01-17 EP EP24706539.4A patent/EP4661768A1/en not_active Withdrawn
  • 2024-01-17 WO PCT/IN2024/050042 patent/WO2024166125A1/en not_active Ceased

Patent Citations (8)

Also Published As

Similar Documents

Legal Events