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WO2014164535A1 - Fil-guide/dispositif d'occlusion partielle pour course intraluminale - Google Patents

Fil-guide/dispositif d'occlusion partielle pour course intraluminale Download PDF

Info

Publication number
WO2014164535A1
WO2014164535A1 PCT/US2014/022730 US2014022730W WO2014164535A1 WO 2014164535 A1 WO2014164535 A1 WO 2014164535A1 US 2014022730 W US2014022730 W US 2014022730W WO 2014164535 A1 WO2014164535 A1 WO 2014164535A1
Authority
WO
WIPO (PCT)
Prior art keywords
distal end
mesh balloon
balloon
hollow tube
tube
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/US2014/022730
Other languages
English (en)
Inventor
Steven J. Ferry
DeLois Marie FERRY
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to US14/774,775 priority Critical patent/US10342547B2/en
Publication of WO2014164535A1 publication Critical patent/WO2014164535A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61B17/12099—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
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • 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
    • A61B17/1214—Coils or wires
    • 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
    • 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
    • A61B2017/12086—Details concerning the detachment of the occluding device from the introduction device magnetically detachable

Definitions

  • the prior art includes methods for occluding vessel openings.
  • Another inventive embodiment includes a device comprising: A solid wire having a tapered distal end, sized to fit within a blood vessel; A coil affixed to the tapered distal end of the solid wire; A compliant mesh balloon having a proximal end and a distal end, wherein the proximal end is attached to the solid wire and the distal end is affixed to the coil, wherein forward movement of the coil elongates the mesh balloon for travel through the blood vessel.
  • Figure 1 a illustrates one side view embodiment of the flexible wire device with a solid wire and a mesh fixed balloon and a distal coil.
  • Figure 5b illustrates a separation of the balloon from the wire.
  • Figure 6 illustrates a side view of the mesh balloon detachable by incorporation of two small magnets in the proximal end of the mesh balloon and the distal mating end of the guidewire
  • Figure 7B illustrates a cross-sectional view of the device embodiment of Figure 7A with the detachable mesh balloon of Figure 7A with magnets oriented in a position that retains the mesh balloon
  • Figure 8 illustrates a longitudinal cross-sectional view of the device with mesh balloon of Figure 7A or Figure 7B wherein the magnet tipped canula extends the length of the proximal wire body and has an actuator which allows the user to rotate the magnet tipped canula and change the polarity of the canula magnet, thus again attaining separation.
  • Figure 10B illustrates a cross-sectional view of the flexible wire device of Figure 10 wherein the cannula is retracted.
  • Figure IOC illustrates a radial cross section of the flexible wire device of Figure 10.
  • Figure 10D illustrates the flexible wire device of Figure 10 wherein the mesh balloon is detached.
  • a layer of lubricious material is bound to an outer surface of the wire 10a, 10b or 22 and mesh balloon 16, 16b or 30 for a distance of 65 cm to 100 cm for the purpose of tracking the wire within a guiding catheter such as is shown at 59 in Figure 4, within a vessel smoother and less traumatic.
  • Yet another aspect of the inventive embodiment is the incorporation of a radiopaque or echogenic coating onto the wire shaft which enables device visualization within a fluoroscopic or ultrasound imaging system.
  • the mesh balloon is fabricated with one or more of a variety of materials that include metals and polymers.
  • the mesh balloon is fabricated using superelastic or shape memory nitinol.
  • FIG. 10b in Figure lb includes a device that has a tube 12b having a telescoped distal end 14b that includes one or more tubular portions 20b that slip fit with respect to each other.
  • the tube and tube portions are sized to fit within a vessel, such as a blood vessel.
  • a distal mesh balloon 16b includes a proximal end 15b affixed to a tube portion of the slip fit and a distal portion 19b affixed to a distal tip 13 of the device 10b.
  • the location of the mesh balloon 16b and distal tip 13 are determined with one or more markers 3.
  • Another device embodiment 20, shown in Figure 2 includes a hollow wire 22 that encloses a tether 21b. Attached to the hollow wire 22 at its distal end is a mesh balloon 30.
  • the device also includes an actuator 28 effective for moving telescoped slip fit tubular portion 24 forward and backward with respect to the hollow wire 22.
  • the mesh balloon 30 includes a proximal end 32 and a distal end 34, wherein the distal end is attached to the tube 24 and the proximal end is affixed to the telescoped slip fit tubular portions wherein forward movement of the telescoped slip fit tubular portions by movement of the actuator elongates the mesh balloon 30 for travel through the blood vessel.
  • the flexible wire device 20 in Figure 2 is constructed using a tandem slip-fit tube combination 24 wherein a proximal end 32 of the mesh balloon 30 is affixed to a distal end 25 of the larger outer tube 24 and the distal end 34 of the balloon 30 to the smaller inner tube tether 2 lb which extends within the lumen of the inner tube 24 and allows for reducing the diameter of the mesh balloon 30 by axially advancing the tether 21b forward in order to reduce the diameter of the mesh balloon 30 and facilitate vascular travel without the need for a catheter. See Figure 2.
  • the flexible solid wire 12 and 12 and flexible hollow wire embodiments 12b and 22 are sized and shaped for navigating through more tortuous locations within the human vasculature for the treatment of various disorders by Interventionalists.
  • Said wire embodiments 12, 12b and 22 have an outer diameter ranging from 0.010 inches (0.25 mm) to 0.038 inches ( 0.95mm).
  • the distal end of the wire embodiments 12, 12b and 22 is tapered to allow for improved tracking characteristics.
  • the taper embodiments 14, 14b and 24 have a length that is in a range from approximately 8 inches to 14 inches.
  • the distal wire diameter at the tip of the taper embodiments 14, 14b and 24 depend on the initial wire diameter. However, the diameter ranges from 0.002 inches to 0.010 inches.
  • Materials for fabrication may include but are not limited to metal wire, both flat and round, metal tubing, polymeric filaments as well as polymeric tubing.
  • a platinum wire or other radiopaque material is formed into a coil and placed over the distal end of the wire, from an occluder 41 to the tip, wherein the tip is finished with a bead to reduce the potential for trauma to the vessel, as shown at 42 in Figure 3.
  • a lubricious coating is applied over a distance of 65cm - 100cm from the distal tip of the wire. Said lubricious coating aids in the tracking of the wire through the vasculature.
  • the purpose of the distal occluder 41 is to provide support during delivery of a device or agent.
  • the compliant mesh balloon also called “occluder”
  • Inventive embodiments disclosed herein employ a wire of metal or polymer as the main body of the device.
  • An occluder is affixed to the distal end of the device.
  • the occluder is designed such that it is compliant so as to be able to compress into a lumen for tracking and delivery.
  • radiopaque markers are placed on either end of the occluder for visualization under imaging techniques and also to affix the mesh balloon to the shaft of the device.
  • a lubricous coating is applied to the device for the purpose of aiding wire movement during tracking and placement.
  • the mesh balloon 54 in Figure 4 is, for some embodiments, fabricated from an appropriate metal or extruded polymer.
  • the mesh balloon is braided, knitted, laser cut, etched or coiled to fabricate the desired shape.
  • the mesh balloon is, for some embodiments, heat shaped on an appropriate mandrel to achieve a variety of configurations which are also self- expanding.
  • a shape memory material such as nitinal can be employed in the fabrication of the mesh balloon, for some embodiments, as well, in order to take advantage of varied shapes at certain temperatures. This may aid in proper deployment.
  • Another unique feature of all of the device embodiments disclosed herein is the ability of the mesh balloon to allow for blood flow through the mesh balloon and parent artery during placement, unlike
  • the mesh balloon also called the occluder, for all embodiments is self- expanding and the radial force applied to the vessel wall is adjustable based on the selected materials' physical properties as well as the dimension of the material being used.
  • the mesh balloon such as 16, 16b, or 30 or
  • the detached mesh balloon is, for some embodiments, placed over the neck of an aneurysm or other vascular deformity, and, given its round to spherical shape, reduces the risk of blocking perforators emptying into the parent artery.
  • the occluder 16, 16b or 30 or 54 is, for some embodiments, selectively open to flow by webbing a portion of the balloon with an appropriate dispersion thereby impeding flow in that segment of the mesh balloon.
  • the webbing is made to be radiopaque so as to further improve visualization and placement.
  • Detachment occurs by changing the polarity on the wire side magnet, resulting in the wire and magnet having the same polarity and repulsion, thus separation of the mesh balloon 74 to the wire side magnet, as shown in Figures 6 and 7A and 7B.
  • the polarity is altered to match the mesh balloon side magnet, thus aiding in separation.
  • Magnetic polarity is changed by using the magnet tipped cannula 71 which extends the length of the proximal wire body and which includes an actuator 73 which allows the user to rotate the magnet tipped cannula and change the polarity of the cannula magnet 72, thus again attaining separation.
  • the cannula movement, controlled by an actuator dial 1 14 is then unlocked and drawn proximally until the flanged plunger 102 is clear of the septum 1 10, as shown in Figure 10B.
  • the septum 110 material is biocompatible and yet mechanically suitable for the system, such as a cured silicone or other appropriate material. See Figures 10A and 10B.
  • the flanged septum is bonded, with an appropriate material, within the marker and is removed by drawing back on the tether cannula thereby releasing the wire/tether from the mesh balloon.

Landscapes

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

Abstract

La présente invention concerne un dispositif qui comprend un tube creux ayant une extrémité distale conique, dimensionné pour s'insérer à l'intérieur d'un vaisseau sanguin. Le dispositif comprend également une attache positionnée à l'intérieur du tube creux et un actionneur efficace pour déplacer l'attache vers l'avant et vers l'arrière par rapport au tube creux. Le dispositif comprend également un ballonnet en treillis compatible ayant une extrémité proximale et une extrémité distale, l'extrémité proximale étant fixée au tube creux et l'extrémité distale étant fixée à l'attache, le mouvement vers l'avant de l'attache entraîné par le mouvement de l'actionneur allongeant le ballonnet en treillis pour le déplacer à travers le vaisseau sanguin.
PCT/US2014/022730 2013-03-06 2014-03-10 Fil-guide/dispositif d'occlusion partielle pour course intraluminale Ceased WO2014164535A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US14/774,775 US10342547B2 (en) 2013-03-06 2014-03-10 Guidewire/ partial occluder for intraluminal travel

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361776492P 2013-03-11 2013-03-11
US61/776,492 2013-03-11

Publications (1)

Publication Number Publication Date
WO2014164535A1 true WO2014164535A1 (fr) 2014-10-09

Family

ID=51658897

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2014/022730 Ceased WO2014164535A1 (fr) 2013-03-06 2014-03-10 Fil-guide/dispositif d'occlusion partielle pour course intraluminale

Country Status (1)

Country Link
WO (1) WO2014164535A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9498604B2 (en) 1997-11-12 2016-11-22 Genesis Technologies Llc Medical device and method
US9561094B2 (en) 2010-07-23 2017-02-07 Nfinium Vascular Technologies, Llc Devices and methods for treating venous diseases
US10342547B2 (en) 2013-03-06 2019-07-09 Neurovasx, Inc. Guidewire/ partial occluder for intraluminal travel
US11266414B2 (en) 2014-06-04 2022-03-08 Vascular Development Corp, Llc Low radial force vascular device and method of occlusion
CN115137948A (zh) * 2022-06-27 2022-10-04 上海心玮医疗科技股份有限公司 一种封堵球囊导管组件
US12440650B2 (en) 2010-05-19 2025-10-14 Vascular Development Corp, Llc Augmented delivery catheter and method

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999008743A1 (fr) * 1997-08-13 1999-02-25 The Regents Of The University Of California Perfectionnements relatifs a des dispositif et procede permettant d'utiliser des enroulements detachables dans des anevrysmes vasculaires et des cavites corporelles
US6066157A (en) * 1998-09-16 2000-05-23 Medtronics Ave, Inc. Anchor joint for coaxial balloon dilatation catheter
US6994717B2 (en) * 1999-03-05 2006-02-07 Board Of Regents, The University Of Texas Systems Occlusion method and apparatus
US8029530B2 (en) * 2002-09-30 2011-10-04 Abbott Cardiovascular Systems Inc. Guide wire with embolic filtering attachment
US20120022574A1 (en) * 2010-07-22 2012-01-26 Kyphon SÀRL Adjustable Surgical Instruments and Methods of Use and Fabrication
US20120330348A1 (en) * 2011-06-03 2012-12-27 Reverse Medical Corporation Embolic Implant and Method of Use

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999008743A1 (fr) * 1997-08-13 1999-02-25 The Regents Of The University Of California Perfectionnements relatifs a des dispositif et procede permettant d'utiliser des enroulements detachables dans des anevrysmes vasculaires et des cavites corporelles
US6066157A (en) * 1998-09-16 2000-05-23 Medtronics Ave, Inc. Anchor joint for coaxial balloon dilatation catheter
US6994717B2 (en) * 1999-03-05 2006-02-07 Board Of Regents, The University Of Texas Systems Occlusion method and apparatus
US8029530B2 (en) * 2002-09-30 2011-10-04 Abbott Cardiovascular Systems Inc. Guide wire with embolic filtering attachment
US20120022574A1 (en) * 2010-07-22 2012-01-26 Kyphon SÀRL Adjustable Surgical Instruments and Methods of Use and Fabrication
US20120330348A1 (en) * 2011-06-03 2012-12-27 Reverse Medical Corporation Embolic Implant and Method of Use

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9498604B2 (en) 1997-11-12 2016-11-22 Genesis Technologies Llc Medical device and method
US12440650B2 (en) 2010-05-19 2025-10-14 Vascular Development Corp, Llc Augmented delivery catheter and method
US9561094B2 (en) 2010-07-23 2017-02-07 Nfinium Vascular Technologies, Llc Devices and methods for treating venous diseases
US10342547B2 (en) 2013-03-06 2019-07-09 Neurovasx, Inc. Guidewire/ partial occluder for intraluminal travel
US11266414B2 (en) 2014-06-04 2022-03-08 Vascular Development Corp, Llc Low radial force vascular device and method of occlusion
US12357314B2 (en) 2014-06-04 2025-07-15 Vascular Development Corp, Llc Low radial force vascular device and method of occlusion
CN115137948A (zh) * 2022-06-27 2022-10-04 上海心玮医疗科技股份有限公司 一种封堵球囊导管组件

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