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WO2016018984A1 - Dispositif d'occlusion et procédés de formation d'occlusions - Google Patents

Dispositif d'occlusion et procédés de formation d'occlusions Download PDF

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Publication number
WO2016018984A1
WO2016018984A1 PCT/US2015/042601 US2015042601W WO2016018984A1 WO 2016018984 A1 WO2016018984 A1 WO 2016018984A1 US 2015042601 W US2015042601 W US 2015042601W WO 2016018984 A1 WO2016018984 A1 WO 2016018984A1
Authority
WO
WIPO (PCT)
Prior art keywords
magnetic
delivery device
magnetic component
connector
occlusion
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2015/042601
Other languages
English (en)
Inventor
Richard GILROY
Philip Johnson
Stephen Waller
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Seguin Sarah
Original Assignee
Seguin Sarah
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Seguin Sarah filed Critical Seguin Sarah
Publication of WO2016018984A1 publication Critical patent/WO2016018984A1/fr
Anticipated expiration legal-status Critical
Priority to US15/419,296 priority Critical patent/US10575839B2/en
Priority to US16/804,909 priority patent/US11478236B2/en
Priority to US17/085,870 priority patent/US12075996B2/en
Ceased legal-status Critical Current

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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
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A61B17/12186—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices liquid materials adapted to be injected
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • 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
    • A61B17/12027—Type of occlusion
    • A61B17/12031—Type of occlusion complete occlusion
    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00632—Occluding a cavity, i.e. closing a blind opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00641—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closing fistulae, e.g. anorectal fistulae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00876—Material properties magnetic

Definitions

  • the disclosure relates generally to occlusion devices and methods of forming occlusions.
  • Tissue adhesive compounds can be used in a variety of medical treatments, including the treatment of vascular malformations and aneurysms, the occlusion of gastric and esophageal varices, the sealing of biliary leaks, and the closure of enteric and pancreatic fistulas. Success rates with such procedures have varied; only reported through small case series and limited case reports. Cyanoacrylates are the compounds most commonly used for these purposes. These compounds are generally liquid monomers that polymerize into longer polymer chains upon exposure to moisture. There are several varieties designed for medical use in humans.
  • Embodiments of the present disclosure include devices and methods for forming an occlusion.
  • Embodiments of an occlusion device include a reusable delivery device, a connector, a magnetic component disposed a distance in a distal direction from a distal end of the delivery device, and a connecting member disposed between the magnetic component and the delivery device, the connecting member being attached to the magnetic component and extending to the delivery device, the connector being separably connected to the connecting member such that a connection between the connector and the connecting member is configured to be formed and separated.
  • Certain embodiments of the present disclosure are configured to inject a magnetic responsive fluid that may function as an occlusion material.
  • the magnetic responsive fluid may be maintained at a treatment site until polymerization, partial polymerization, or curing of the adhesive has occurred.
  • Embodiments of the present disclosure allow for formation of an occlusion without the occlusion adhering to or attaching to the delivery device and without moving beyond the treatment site to other unintended areas.
  • Certain embodiments include an electromagnet conductively associated with the connecting member and/or the connector and a first current source such that electric current can pass to the magnetic component from a first current source.
  • Certain embodiments of the connector include a connector coil
  • certain embodiments of the connecting member include a member coil, the connector coil and the member coil being in association with each other.
  • Certain embodiments of the connector coil include a connector core in association with the connector coil, and a member core in association with the member coil.
  • the connector core and/or member core are permanent magnets.
  • Certain embodiments include a second current source, the second current source being conductively associated with the connector and/or connector coil and being arranged to deliver current in a direction opposite the first current source such that the connection between the connector and the connecting member may be neutralized or separated upon association with or activation of the second current source.
  • Certain embodiments include a magnetic component wherein at least a portion of the magnetic component is formed as a conduit, the conduit thereby defining a second delivery device, the second delivery device including a proximal opening and a distal opening.
  • Certain embodiments include an expandable element disposed at the distal opening of the second delivery device and/or at the magnetic component, the expandable element being in association with the magnetic component.
  • Certain embodiments of a method of forming a treatment occlusion include: positioning an occlusion device at a treatment site, activating a magnetic component disposed a distance in a distal direction from a distal end of a delivery device, the distance between the magnetic component and the distal end of the delivery device defining a clearance; injecting an amount of a magnetic responsive fluid through the delivery device such that the magnetic responsive fluid is removed from the distal end of the delivery device across the clearance and toward the magnetic component; allowing the magnetic responsive fluid to at least partially polymerize, the at least partially polymerized magnetic responsive fluid and the associated magnetic component defining an occlusion structure; and dissociating the delivery device from the magnetic component such that the delivery device can be removed from the treatment site without disturbing the occlusion structure.
  • Certain embodiments of a method of forming a treatment occlusion include an expandable element disposed at the distal opening of a second delivery device, the expandable element being in association with the magnetic component such that activation of the magnetic component brings the magnetic responsive fluid into contact with the expandable element.
  • the expandable element is non-porous to the magnetic responsive fluid such that upon movement of the magnetic responsive fluid through the second delivery device and activation of the magnetic component, the magnetic responsive fluid is held on a distal side of the expandable element, and in certain embodiments the expandable element is formed to be at least partially porous to the magnetic responsive fluid such that upon movement of the magnetic responsive fluid through the second delivery device and activation of the magnetic component, the magnetic responsive fluid is held on a distal side of the expandable element, within the structure of the expandable element, on a proximal side of the expandable element, or some combination.
  • Certain embodiments of a method of forming a treatment occlusion include injecting a second amount of the magnetic responsive fluid at the treatment site, the second amount enclosing the connecting member and any other portions of the magnetic component extending from the occlusion structure.
  • FIG. 1 is a cross-sectional side view of an occlusion device in accordance with embodiments disclosed herein.
  • FIG. 2 is a top view of an occlusion device in accordance with embodiments disclosed herein.
  • FIG. 3 is a cross-sectional side view of an occlusion device in accordance with embodiments disclosed herein.
  • FIG. 4 is a cross-sectional side view of an occlusion device in accordance with embodiments disclosed herein.
  • FIGS. 5 through 8 illustrate a magnetic component of an occlusion device in accordance with embodiments disclosed herein.
  • FIG. 9 is a side view of an occlusion device in accordance with embodiments disclosed herein.
  • FIG. 10 is a side view of an occlusion device in accordance with embodiments disclosed herein.
  • FIGS. 11 through 13 illustrate a connector and connecting member of an occlusion device in accordance with embodiments disclosed herein.
  • FIGS. 14 through 17 illustrate a method of forming an occlusion in accordance with embodiments disclosed herein.
  • FIGS. 18 through 22 illustrate a method of forming an occlusion in accordance with embodiments disclosed herein.
  • Embodiments of the present disclosure may be configured for use in a variety of treatment settings.
  • the device and methods may be used in the closure of fistulas (such as enterocutaneous, biliary, rectovaginal, enterovesicle, enterourethral, esophageal, etc.), in the treatment of biliary or pancreatic duct leaks, and in the treatment of gastric varices, aterio venous malformations, and vascular aneurysms.
  • fistulas such as enterocutaneous, biliary, rectovaginal, enterovesicle, enterourethral, esophageal, etc.
  • gastric varices such as enterocutaneous, biliary, rectovaginal, enterovesicle, enterourethral, esophageal, etc.
  • gastric varices such as enterocutaneous, biliary, rectovaginal, enterovesicle, enterourethral,
  • aspects of the present disclosure are directed to occlusion devices and methods of forming occlusions that allow precise location and control of an occlusion and that allow a delivery device to be dissociated and extracted from a forming or formed occlusion without disrupting the occlusion or surrounding tissues or structures.
  • an occlusion device 102 may include a delivery device 104, a magnetic component 106, a connecting member 108, and a connector 110.
  • the delivery device 104 may be formed so as to be able to carry, transport, channel, or otherwise deliver the material that will form the occlusion from a proximal end 114 to a distal end 116 and/or beyond the distal end 116.
  • the delivery device 104 may be formed as a needle, a catheter, or another lumen-containing structure capable of delivery of the material that will form the occlusion.
  • the magnetic component 106 may be disposed a distance in a distal direction from the distal end 116 of the delivery device 104.
  • the distance between the magnetic component 106 and the distal end 116 of the delivery device 104 may define a clearance 112.
  • the clearance 112 may be 0.1 to 1 cm, or 1 to 2 cm, or 2 to 3 cm, or 3 to 4 cm, or 4 to 5 cm.
  • the clearance can range from 0.1 to 5 cm, 0.5 to 4 cm, or 1 to 3 cm.
  • the ratio of the clearance to the diameter of the delivery device 104 (e.g., inside diameter) can be 0.25 to 5, or 0.5 to 4, or 0.75 to 3, or 1 to 2.
  • the magnetic component 106 may be capable of generating a magnetic field.
  • the magnetic component 106 may be a permanent magnet and/or an electromagnet, such as an electromagnetic antenna.
  • the magnetic component 106 may be an electromagnet, and the electromagnet may be conductively associated with the connecting member 108 and the connector 110 such that electric current can pass to the magnetic component 106 from a current source 118.
  • the magnetic component 106 can be configured such that the strength of the magnetic field associated with the magnetic component 106 can be modulated to provide a desired attractive force (e.g., a "pulling" force) disposed away from the distal end 116 of the delivery device 104.
  • a desired attractive force e.g., a "pulling" force
  • the magnetic component 106 can be configured to provide a resting magnetic field and an augmented magnetic field.
  • the magnetic component may include a permanent magnet component to provide a resting magnetic field, and an electromagnet component to augment the magnetic field upon actuation.
  • the magnetic component 106 can be configured to provide a magnetic flux density ranging from 0.1 mT to 0.5 mT, or from 0.5 mT to 1 mT, or from 1 mT to 3 mT, or from 3 mT to 6 mT.
  • the embodiment shown in FIGS. 1 and 2 may include a lead 120 disposed between the current source 118 and the connector 110.
  • the connector 110 may be in conductive association with the connecting member 108 through, for example, direct contact or inductive association.
  • the lead 120 may be disposed between the current source 118 and the connecting member 108, or between the current source 118 and the magnetic component 106.
  • the magnetic component 106 may not be in conductive association with the connecting member 108 or connector 110.
  • the connector 110 may not be in conductive association with the connecting member 108 or the magnetic component 106.
  • the connector 110 and/or the connecting member 108 may not be in conductive association with the magnetic component 106 or with each other.
  • the conductive associations of the components of an embodiment when an embodiment has such a conductive association, may be established by direct connection, such as by one or more electrical leads, or by inductive association, or by a combination of both.
  • the magnetic component 106 may be attached to a connecting member 108.
  • the connecting member 108 may be disposed between the magnetic component 106 and the delivery device 104.
  • the connecting member 108 may have a curved construction.
  • the connecting member 108 may be joined at or near the magnetic component 106 at or near a distal apex of the curve of the connecting member 106, thereby forming a pair of curved struts between the delivery device 104 and the magnetic component 106.
  • the connecting member 108 may also be constructed in a variety of other forms.
  • the connecting member 108 may have a linear or non-curved construction.
  • the connecting member 108 may be formed with portions that are non-curved and portions that are curved.
  • the connecting member 108 may be formed with one, two, or more points of connection to the delivery device 104.
  • the embodiment of the connecting member 108 shown in FIGS. 1 and 2 may be constructed with two points of connection to the delivery device 104, but other embodiments may include only one point of connection to the delivery device 104, or may include more than two points of connection to the delivery device 104.
  • the occlusion device 102 may include one connecting member 108 or a plurality of connecting members 108 disposed between the magnetic component 106 and the delivery device 104. Additionally, the connecting member 108 or a plurality of connecting members 108 may form one contiguous or integrated formation, or may include one or more separate connecting members 108 not connected directly to each other, or may include some connecting members 108 that are connected and integrated with each other and others that are not. In some embodiments, a portion of the connecting member 108 (or a portion of one or more connecting members, in embodiments including a plurality of such) may be integrated with a magnetic component. For example, one or more electrical leads may be coiled around a portion of the connecting member so as to provide the portion of the connecting member with electromagnetic functionality.
  • the magnetic component 106 may be constructed in a variety of forms.
  • the magnetic component 106 may be formed from a ferromagnetic material, partially ferromagnetic material, other material capable of functioning as a permanent magnet, or combinations thereof.
  • the magnetic component 106 may be formed as an electromagnet capable of being modulated, activated and deactivated in response to application of an electrical current.
  • the electromagnet may be capable of being fine-tuned through other alterations of the applied current. For example, the strength of the magnetic field near the magnetic component may be altered by altering the current and/or voltage of the current source.
  • the magnetic component 106 may be formed so that only a portion actively generates a magnetic field or is capable of actively generating a magnetic field, thereby defining a magnetically active portion of the magnetic component 106.
  • a portion of the magnetic component 106 may be formed as a permanent magnet, while another portion may be formed as a post, member, pin, or other structure used to support or attach to the magnetically active portion of the magnetic component 106.
  • a portion of the magnetic component may function as an electromagnet, while another portion may be formed as a post, member, pin, or other structure used to support or attach to the magnetically active portion of the magnetic component 106.
  • the magnetically active portion can function to provide a magnetic force to draw a magnetic responsive fluid away from the distal end 116 of the delivery device 104, while the non-magnetically active portion can function to provide or augment the clearance 112 separating the magnetically active portion of the magnetic component 106 from the distal end 116 of the delivery device 104.
  • the magnetic component 106 may also include a tip structure 122.
  • the tip structure 122 may be formed as an integral piece with the rest of the magnetic component 106, or may be a separate piece attached or joined to the rest of the magnetic component 106.
  • the tip structure 122 may be a same or different type of magnet and/or may generate a magnetic field of similar or dissimilar strength relative to the rest of the magnetic component 106.
  • the tip structure 122 may be a permanent magnet and the magnetic component 106 may also include coils allowing it to function as an electromagnet.
  • the tip structure 122 may be the only portion of the magnetic component 106 that produces a magnetic field (e.g., the tip structure 122 is a permanent magnet or electromagnet), while the other portions of the magnetic component 106 may not produce a magnetic field or may produce a magnetic field of different strength.
  • the tip structure 122 may provide a magnetic field of greater magnetic strength relative to the other portions of the magnetic component 106 in order to provide or contribute to a magnetic field gradient.
  • the magnetic component 106 and/or tip structure 122 can be configured to provide a magnetic field that increases in strength in the distal direction.
  • FIGS. 1 and 2 may include a connector 110.
  • the connector 110 may be disposed near the distal end 116 of the delivery device 104.
  • the connector 110 may be disposed within the internal lumen of the delivery device 104 near the distal end 116 of the delivery device 104.
  • the connector 110 may also be disposed at other locations such as other portions of the internal lumen of the delivery device 104, at or along the outer perimeter of the delivery device 104, or at the distal edge of the delivery device 104.
  • the connector 110 may be formed as one integrated component, such as an annular ring or partial ring (e.g., a sectioned and/or perforated ring) disposed along a portion of the inner lumen of the delivery device 104, or may be formed from separate, non-contiguous and/or independent components.
  • the connector 110 is in association with the connecting member 108 in such a way as to allow a connection between the connector 110 and a connecting member 108 to be selectively formed and separated.
  • the connector 110 may form a mechanical attachment to the connecting member 108 through the use of a latch, pin, stop, brace, and/or other mechanical attachment or locking mechanism capable of coupling, joining, or engaging a connecting member 108.
  • the connector 110 may include magnetic components for selectively forming and separating a connection to the connecting member 108.
  • FIG. 3 illustrates another embodiment of an occlusion device 302.
  • the embodiment shown in FIG. 3 may include elements of the embodiment of FIGS. 1 and 2 and therefore, the description of FIGS. 1 and 2 are hereby incorporated by reference.
  • FIG. 3 illustrates an occlusion device 302 wherein the magnetic component 306 is formed as a cylindrical member.
  • the magnetic component 306 of the embodiment shown in FIG. 3 may be formed from a ferromagnetic material, a partially ferromagnetic material, or another material capable of functioning as a permanent magnet.
  • the magnetic component 306 may be or may include an electromagnet.
  • coils forming the electromagnet may be disposed within the structure of the magnetic component 306 or within a portion of the magnetic component
  • FIG. 4 also illustrates an occlusion device 402 wherein the magnetic component 406 is formed as a cylindrical member.
  • the embodiment shown in FIG. 4 may include elements of the embodiments of FIGS. 1 through 3 and therefore, the description of FIGS. 1 through 3 are hereby incorporated by reference.
  • the magnetic device 406 may be formed as an electromagnet including one or more coils 422 surrounding a coil core 424.
  • the embodiment of the magnetic component 406 illustrated in FIG. 4 may function as an electromagnet, with coils 422 disposed along the outside perimeter of the coil core 424.
  • the coil core 424 may also be a ferromagnetic material and/or may be a permanent magnet capable of producing a magnetic field when the electromagnet is deactivated.
  • the magnetic component 406 or a portion of the magnetic component 406 may be formed as a conduit, hose, port, or channel to define a second delivery device, such that a magnetic responsive fluid and/or another occlusion forming material leaving the distal opening of the delivery device 404 can enter the proximal opening of the second delivery device and travel toward and out of the distal opening of the second delivery device before associating with the magnetically active portion of the magnetic component 406.
  • the magnetic component 4 may be formed as a second delivery device, such that at least a portion of a magnetic responsive fluid and/or another occlusion forming material leaving the delivery device 404 will be directed through the lumen of the second delivery device and out of the distal opening of the second delivery device before associating with the magnetically active portion of the magnetic component 406 disposed, in this example, along the outside perimeter or a portion of the outside perimeter of the magnetic component 406.
  • FIGS. 5 through 8 illustrate other embodiments of magnetic components
  • FIGS. 5 through 8 illustrate that the shape and structure of a magnetic component may be varied.
  • a magnetic component may have a circular structure, an elliptical structure, a polygonal structure (either regular or irregular), a branched structure, another suitable structure, or combinations thereof.
  • a magnetic component may include a combination of structures and shapes, with or without branched structures that may be different or similar in shape to other branched structures.
  • FIGS. 9 and 10 illustrate other embodiments of an occlusion device 902,
  • the expandable element 926 may be formed so as to be disposed in a collapsed or closed state, as illustrated in FIG. 9.
  • the expandable element 926 may be formed from a flexible material designed so as to flex radially outward unless held in place, for example, mechanically, electro-mechanically, magnetically, by another appropriate mechanism, or combinations thereof. Upon release, the expandable element 1026 may move to an open position, as illustrated in FIG. 10.
  • the expandable element 926, 1026 may be formed or partially formed from a self-expanding material that expands upon an induced change or natural occurrence in the environment interacting with the expandable element 926, 1026.
  • the expandable element 926, 1026 may be formed from a shape-memory material, such as a nickel titanium alloy (e.g., nitinol).
  • the expandable element 926 may be formed so as to be one integrated and solid structure or may be formed from separate components or pieces.
  • the expandable element 926 may be formed as a single piece or from an array of plates, sheets, or panels that either overlay or abut each other upon expansion or that leave gaps or breaks between each or some of them.
  • the expandable element 926 may be formed as a wire frame, hub and spoke, perforated, honeycombed, or porous structure.
  • the expandable elements 926, 1026 can be configured to open to an angle of 15 to 30, 30 to 45, 45 to 60, 60 to 75, 75 to 90, 90 to 105, 105 to 120, 120 to 135, or 135 to 150 degrees. In some embodiments, the expandable elements 926, 1026 can open greater than 150 degrees.
  • FIGS. 11-13 illustrate other embodiments of connectors and connecting members.
  • the embodiments illustrated in FIGS. 11-13 may be included in part or in combination with any of the embodiments illustrated in FIGS. 1-10, and, therefore, the descriptions of FIGS. 1-10 are hereby incorporated by reference.
  • the connector 1110 may include a connector coil 1128 and/or the associated connecting member 1108 may include a member coil 1130 in a manner capable of forming a magnetic connection between the connector coil 1128 and the associated member coil 1130.
  • a connection between the connector 1110 and the connecting member 1108 can be formed by the magnetic field resulting from passing current through the connector coil 1128 and/or the member coil 1130, and the connection can be separated upon reducing or eliminating such current.
  • FIG. 12 illustrates another embodiment of a connector 1210 and connecting member 1208.
  • the embodiment shown in FIG. 12 may include elements of the embodiment of FIG. 11 and, therefore, the description of FIG. 11 is hereby incorporated by reference.
  • the connector 1210 may include a connector coil 1228 and a connector core 1232 in association with the connector coil 1228.
  • the connecting member 1208 may also include a member coil 1230 and a member core 1234 in association with the member coil 1230.
  • the connector core 1232 and/or the member core 1234 may include a ferromagnetic material, a partially ferromagnetic material, another material capable of functioning as a permanent magnet or capable of altering the strength of the magnetic field upon passing current through the associated coils, or combinations thereof.
  • the connector core 1232 and the member core 1234 may have no or minimal magnetic attraction to each other in the absence of any applied current, such that any connection between the connector 1210 and the connecting member 1208 is limited or weak and is capable of being easily separated.
  • the magnetic attraction may strengthen, forming a connection suitable for positioning of the device.
  • the connection may return to a weakened or separated state, easing separation of the connector 1210 and the connecting member 1208.
  • the connector 1210 may include a plurality of connector coils 1228, with some or each of the connector coils 1228 containing one or more connector cores 1232.
  • the connecting member 1208 may include one or more member coils 1230, with some or each of such member coils 1230 containing one or more member cores 1234.
  • FIG. 13 illustrates another embodiment of a connector 1310 and connecting member 1308.
  • the embodiment shown in FIG. 13 may include elements of the embodiments of FIGS. 11-12 and therefore, the descriptions of FIGS. 11-12 are hereby incorporated by reference.
  • a first current source 1318 may pass current to the connector 1310 and the connector coil 1328. When in sufficient proximity to the member coil 1330, a current passing through the connector coil 1328 may induce a current in the member coil 1330.
  • the connector core 1332 and the member core 1334 may be formed so as to induce or create a magnetic connection between connector 1310 and the connecting member 1308.
  • the connector core 1332 and/or the member core 1334 may be permanent magnets capable of forming a magnetic connection in the absence of a current from the first current source 1318, and/or may act as electromagnet cores that strengthen the magnetic connection as current passes through the connector coil 1328 and/or member coil 1330.
  • This embodiment may also include a second current source 1336 conductively associated with the connector coil 1328.
  • the second current source 1336 may be arranged to deliver current in a direction opposite that of the first current source 1318 such that upon application of the second current source 1336, the magnetic field generated by the connector coil 1328 and/or connector core 1332 is weakened, neutralized, or reversed.
  • the connection between the connector 1310 and the connecting member 1308 may then be separated or more easily separated.
  • the first and second current sources may be the same, and reversing the direction of current is done simply by reversing a polarity of the current source.
  • a connector and connecting member may be detachably coupled through mechanical means, such as with one or more pins, latches, clasps, and/or friction fitted parts, for example.
  • FIGS. 14 through 17 illustrate an embodiment of an occlusion formation method.
  • an occlusion device 1402 is positioned at a treatment site.
  • the occlusion device 1402 may be any of the embodiments of an occlusion device illustrated in FIGS. 1-13 or any combination of elements described in relation to such embodiments, and therefore the descriptions of FIGS. 1-13 are hereby incorporated by reference.
  • the treatment site may be anywhere an occlusion is required or desired, such as at or near a fistula, such as an enterocutaneous, biliary, rectovaginal, enterovesicle, enterourethral, or esophageal fistula, or at or near a duct, such as a biliary or pancreatic duct. Additionally, the treatment site may be at or near gastric varices, arteriovenous malformations, or vascular aneurysms.
  • the magnetic component 1406 of the occlusion device 1402 may be activated.
  • This may be accomplished, for example, by applying current from a current source (not shown) to the magnetic component 1406, which, in the embodiment illustrated in FIGS. 14 through 17, may be an electromagnet.
  • a current source not shown
  • a magnetic field may be created originating at the magnetic component 1406.
  • an occlusion forming material may be injected through the delivery device 1404 toward the distal end of the delivery device 1404.
  • the occlusion forming material may include a magnetic responsive fluid.
  • a magnetic responsive fluid may be a cyanoacrylate mixed with a compound having a magnetic potential.
  • the magnetic responsive fluid and any other associated occlusion forming material may move from the distal end of the delivery device 1404 across the clearance 1412 and toward the magnetic component 1406.
  • the magnetic component 1406 may help prevent the magnetic responsive fluid from interacting with and potentially adhering to the delivery device 1404. Additionally, the magnetic component 1406 may help prevent the magnetic responsive fluid and any other associated occlusion forming material from passing beyond the magnetic component 1406 and into other areas beyond the treatment site.
  • the magnetic responsive fluid may polymerize or at least partially polymerize to form an occlusion structure 1438 as illustrated in FIG. 15.
  • the occlusion structure 1438 is disposed across the clearance 1412 such that the delivery device 1404 is not in direct contact with any portion of the occlusion structure 1438 formed around and containing the magnetic component 1406.
  • the connection between the connector (not shown) and the connecting member 1408 may be neutralized or separated, and the delivery device 1404 may be dissociated from the occlusion structure 1438 and the connecting member 1408 as illustrated in FIG. 16.
  • a second amount of magnetic responsive fluid may then be injected at the treatment site.
  • the second amount may preferably be an amount sufficient to cover or enclose the connecting member 1408 and any other portions of the magnetic component 1406 extending from the occlusion structure 1438 as illustrated in FIG. 17.
  • FIGS. 18 through 22 illustrate another embodiment of an occlusion formation method.
  • an occlusion device 1502 is positioned at a treatment site.
  • the occlusion device 1502 may include an expandable element.
  • the occlusion device 1502 may incorporate elements of any of the embodiments of an occlusion device illustrated in FIGS. 1-13, and therefore the descriptions of FIGS. 1-13 are hereby incorporated by reference.
  • the embodiment illustrated in FIGS. 18 through 22 is similar to the embodiment illustrated in FIGS. 14 through 17, and therefore the descriptions of FIGS. 14 through 17 are hereby incorporated by reference.
  • the occlusion device 1502 includes an expandable element 1526.
  • the expandable element 1526 may be contained in a closed or collapsed state. Upon positioning the occlusion device 1502 at the treatment site, the expandable element 1526 may expand. For example, the expandable element 1526 may expand so as to contact a duct wall or other areas of the treatment site as illustrated in FIG. 19.
  • the magnetic component 1506 of the occlusion device 1502 may be activated.
  • a magnetic responsive fluid may be injected through the delivery device 1504 toward the distal end of the delivery device 1504.
  • the magnetic responsive fluid is further injected through a second delivery device defined by a conduit formed within at least a portion of the magnetic component 1506 such that at least a portion of the magnetic responsive fluid is channeled through and out of the distal opening of the second delivery device and onto the expandable element 1526.
  • the magnetic responsive fluid is channeled to the distal side of the expandable element 1526, where it is held within or against the expandable element 1526 by the magnetic force of the magnetic component 1506 as illustrated in FIG. 20.
  • the magnetic responsive fluid may polymerize or at least partially polymerize to form an occlusion structure 1538.
  • the occlusion structure 1538 can be disposed within or against the expandable element 1526 such that the delivery device 1504 is not in direct contact with any portion of the occlusion structure 1538.
  • a second amount of magnetic responsive fluid may then be injected at the treatment site.
  • the second amount may preferably be an amount sufficient to cover or enclose the connecting member 1508 and any other portions of the magnetic component 1506 and/or the expandable element 1526 extending from the occlusion structure as illustrated in FIG. 22.
  • the terms “approximately,” “about,” and “substantially” as used herein represent an amount or condition close to the stated amount or condition that still performs a desired function or achieves a desired result.
  • the terms “approximately,” “about,” and “substantially” may refer to an amount that deviates by less than 10%, or by less than 5%, or by less than 1 %, or by less than 0.1 %, or by less than 0.01 % from a stated amount or condition.
  • elements described in relation to any embodiment depicted and/or described herein may be combinable with elements described in relation to any other embodiment depicted and/or described herein.
  • any element described in relation to an embodiment depicted in Figures 1 through 13 may be combinable with an embodiment described in relation to an embodiment depicted in Figures 14 through 22.

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Abstract

La présente invention concerne des dispositifs et des procédés pour former des occlusions. Un dispositif de formation d'occlusion comprend un cathéter d'administration et un composant magnétique disposé à une certaine distance dans une direction distale à partir d'une extrémité distale du cathéter d'administration. Un élément de connexion s'étend entre le composant magnétique et le cathéter d'administration et est couplé de manière amovible au cathéter d'administration par un connecteur. Le cathéter d'administration est configuré pour diriger un fluide sensible magnétique formant des occlusions vers un site de traitement, où le composant magnétique attire le fluide hors et à l'opposé de l'extrémité distale du dispositif d'administration. L'élément de connexion et le composant magnétique sont configurés de façon à être détachés du cathéter d'administration de sorte que le cathéter d'administration puisse être retiré du site de traitement.
PCT/US2015/042601 2014-07-29 2015-07-29 Dispositif d'occlusion et procédés de formation d'occlusions Ceased WO2016018984A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US15/419,296 US10575839B2 (en) 2014-07-29 2017-01-30 Solenoid occlusion device
US16/804,909 US11478236B2 (en) 2014-07-29 2020-02-28 Solenoid occlusion device
US17/085,870 US12075996B2 (en) 2014-07-29 2020-10-30 Solenoid occlusion device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201462030458P 2014-07-29 2014-07-29
US62/030,458 2014-07-29

Related Child Applications (1)

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US15/419,296 Continuation-In-Part US10575839B2 (en) 2014-07-29 2017-01-30 Solenoid occlusion device

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WO2016018984A1 true WO2016018984A1 (fr) 2016-02-04

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3995209A (en) * 1975-01-08 1976-11-30 Pelcon Limited Inductive connectors
US6364823B1 (en) * 1999-03-17 2002-04-02 Stereotaxis, Inc. Methods of and compositions for treating vascular defects
US6409721B1 (en) * 1998-02-19 2002-06-25 Target Therapeutics, Inc. Process for forming an occlusion in a body cavity
US6414577B1 (en) * 2000-02-14 2002-07-02 Jerzy Hoffman Core with coils and permanent magnet for switching DC relays, RF microwave switches, and other switching applications
US20020087044A1 (en) * 2000-12-28 2002-07-04 Scimed Life Systems, Inc. Apparatus and method for internally inducing a magnetic field in an aneurysm to embolize aneurysm with magnetically-controllable substance
US20040133189A1 (en) * 2002-12-27 2004-07-08 Olympus Corporation Surgical operation apparatus and control method thereof

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3995209A (en) * 1975-01-08 1976-11-30 Pelcon Limited Inductive connectors
US6409721B1 (en) * 1998-02-19 2002-06-25 Target Therapeutics, Inc. Process for forming an occlusion in a body cavity
US6364823B1 (en) * 1999-03-17 2002-04-02 Stereotaxis, Inc. Methods of and compositions for treating vascular defects
US6414577B1 (en) * 2000-02-14 2002-07-02 Jerzy Hoffman Core with coils and permanent magnet for switching DC relays, RF microwave switches, and other switching applications
US20020087044A1 (en) * 2000-12-28 2002-07-04 Scimed Life Systems, Inc. Apparatus and method for internally inducing a magnetic field in an aneurysm to embolize aneurysm with magnetically-controllable substance
US20040133189A1 (en) * 2002-12-27 2004-07-08 Olympus Corporation Surgical operation apparatus and control method thereof

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