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WO2014083559A1 - Dispositif d'occlusion vasculaire et procédés d'utilisation - Google Patents

Dispositif d'occlusion vasculaire et procédés d'utilisation Download PDF

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Publication number
WO2014083559A1
WO2014083559A1 PCT/IL2013/000087 IL2013000087W WO2014083559A1 WO 2014083559 A1 WO2014083559 A1 WO 2014083559A1 IL 2013000087 W IL2013000087 W IL 2013000087W WO 2014083559 A1 WO2014083559 A1 WO 2014083559A1
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WO
WIPO (PCT)
Prior art keywords
lumen
proximal end
inflation
distal end
connector
Prior art date
Application number
PCT/IL2013/000087
Other languages
English (en)
Inventor
Igor Waysbeyn
Irina Kavounovski
Original Assignee
Hdh Medical Ltd
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 Hdh Medical Ltd filed Critical Hdh Medical Ltd
Publication of WO2014083559A1 publication Critical patent/WO2014083559A1/fr

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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
    • A61B17/12027—Type of occlusion
    • A61B17/1204—Type of occlusion temporary 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
    • 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
    • A61B17/12136—Balloons
    • 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
    • A61B17/1204—Type of occlusion temporary occlusion
    • A61B17/12045—Type of occlusion temporary occlusion double occlusion, e.g. during anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A61B2017/22042—Details of the tip of the guide wire
    • A61B2017/22044—Details of the tip of the guide wire with a pointed tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22067—Blocking; Occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22082—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
    • A61B2017/22084—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance stone- or thrombus-dissolving

Definitions

  • the present disclosure relates in general to a device for occluding blood vessels.
  • the present disclosure relates to an inflatable device providing for occluding the flow of body fluids through vessel or ducts and/or sealing an intrusive vascular wound such as caused by stabbing or shotgun.
  • Vascular loops and/or clamps are normally employed for blocking the flow of body fluids through vessels and/or ducts during surgical procedures.
  • These typical vessel- occluding devices are designed in "O", “J” or “C” shapes with vessel contacting surfaces on their inner aspects which completely surround the vessel.
  • occluding pressure is applied to the vessel (such as by inflation of one or more balloons within the device in contact with the vessel)
  • the vessel is compressed by a constricting force applied around its entire circumference. It has been observed that significant trauma to the vessel often results from the use of such prior art occluding devices. The cause of this trauma was attributed to the design of these devices and the way in which they apply compressive forces to the vessel.
  • the radially directed compressive forces applied completely around the circumference of the vessel preclude lateral extension of the vessel, thus forcing the vessel tissue to compress longitudinally, a direction in which it has relatively little compliance.
  • the high compressive forces required to effect this longitudinal compression and occlusion of the lumen of the vessel result in an actual crushing of the vessel tissue, with consequent damage.
  • the trauma is aggravated in the case of diseased vessels, such as those suffering from the effects of arteriosclerosis.
  • the thickened, irregular shaped and hardened vessel wall exhibits less than the normal degree of compliance upon compression, and the encircling compressive forces of the prior art clamps do not accommodate localized excessive thickening.
  • Occlusion Balloon Catheter that are provided by BOSTON SCIENTIFIC of MA USA are especially designed for occluding blood vessels of a relatively large diameter.
  • Devices especially used for occluding a patient's aorta during stopped-heart cardiac procedures are known to comprise a flexible, thin-profile balloon that encloses a tubular body. Together, the balloon and tubular body occlude a blood vessel.
  • the balloon member is attached near the distal end of the tubular member.
  • the width of the contact area of the balloon, which contacts the inner wall of the blood vessel, is substantially narrower than the diameter of the balloon (in other words, looking like a squat ball with the pole-to-pole distance being substantially shorter than the equator diameter).
  • the balloon is typically made of a low compliance material which limits the level by which the balloon radially (e.g., in the equator) and/or longitudinally (e.g., pole-to-pole) expands.
  • the tubular body comprises a first lumen which carries blood between the patient and an external medical device. Another lumen is used to inflate and deflate the balloon. Other optional lumens can be used to measure blood pressure, introduce cardioplegia solution or drugs, and/or compensate for over-inflation of the balloon.
  • the tubular body may be bent near the distal end to allow the balloon member to be directly introduced into the blood vessel. A suitable incision through the sidewall of the targeted vessel has to be made prior to the introduction of the disclosed device into the targeted blood vessel.
  • a vascular occluding device comprising a rigid connector lumen having a proximal end and a perforating tip proximal end; an inflation lumen, operably coupled to the rigid connector lumen having an open distal end and a closed proximal end, the inflation lumen defining at least one inflation aperture at the proximal end, wherein the rigid tube extends beyond the closed proximal end of the inflation lumen; a grasping member having an open distal end and a proximal end, the proximal end operably coupled to the distal end of the connector lumen, wherein the grasping member defining a connector tube therethorough and an inflation tube fitting, in fluid communication with the inflation lumen; a distensible sheath having a distal end and a proximal end, disposed between the perforating tip of the rigid connector at its proximal end, and the proximal end of the grasping member at its distal end;
  • a method of reversibly occluding a fluid flow in a body lumen at a predetermined occlusion site inside said body comprising the steps of: providing a vascular occlusion device comprising: a rigid connector lumen having a proximal end and a perforating tip proximal end; an inflation lumen, operably coupled to the rigid connector lumen having an open distal end and a closed proximal end, the inflation lumen defining at least one inflation aperture at the proximal end, wherein the rigid tube extends beyond the closed proximal end of the inflation lumen; a grasping member having an open distal end and a proximal end, the proximal end operably coupled to the distal end of the connector lumen, wherein the grasping member defining a connector tube therethorough and an inflation tube fitting, in fluid communication with the inflation lumen; a distensible sheath having a distal end and a
  • VOD vascular occluding devices
  • VOD vascular occluding devices
  • FIG. 1 is an isometric view of an embodiment of the vascular occluding devices (VOD) described herein;
  • FIG. 2 is an illustration of an enlarged view of section A in FIG. 1;
  • FIG. 3 is an illustration of Y-Z cross-section of FIG. 2;
  • FIG. 4 is an isometric view of the embodiment of the VOD of FIG. 1 in an inflated state
  • FIG. 5 is an enlargement of detail B in FIG. 4;
  • FIG. 6, is an illustration of Y-Z cross-section of FIG. 5;
  • FIG. 7, is an enlargement of detail B in FIG. 4, for another embodiment of the vascular occluding devices (VOD) described herein;
  • VOD vascular occluding devices
  • FIG. 8 is an illustration of Y-Z cross-section of FIG. 7 in its deflated state
  • FIG. 9 is an illustration of Y-Z cross-section of FIG. 7 in deflated state
  • FIG. 10 is an illustration of Y-Z cross section of another embodiment of the vascular occluding devices (VOD) described herein in an inflated state;
  • FIG. 11 is an enlargement of detail C in FIG. 10;
  • FIG. 12 is an illustration of Y-Z cross-section of an embodiment of the vascular occluding devices (VOD) described herein;
  • FIG. 13 is an enlargement of detail D in FIG. 12;
  • FIG. 14 is a X-Y cross section illustration of an embodiment of the use of the vascular occluding devices (VOD) described herein in which the VOD penetrates both vessel walls;
  • VOD vascular occluding devices
  • FIG. 15 is a Y-Z cross section illustration of another embodiment of the use of the vascular occluding devices (VOD) described herein in which the VOD penetrates both walls in an arteriosclerotic vessel; and
  • FIG. 16 is a X-Y cross section illustration of yet another embodiment of the use of a couple of the vascular occluding devices (VOD) described herein in which the VODs penetrate one vessel wall at two locations, isolating a treatment zone.
  • VOD vascular occluding devices
  • vascular occluding device More specifically, provided herein are vascular occluding devices having substantially distensible sheath capable of obtaining a prolate spheroid (in other words, a prolate ellipsoid) shape having a variable polar axis, with an integral perforating tip, capable of effectively temporarily and reversibly occluding vessels of varying diameters and shapes.
  • the VOD described herein can have an elongated rigid connector lumen having a distal end and an open proximal end with a perforating tip and a longitudinal axis that is substantially larger than the diameter of the connector lumen (i.e.
  • the connector lumen can be curved along the longitudinal axis, wherein the curved portion can be anywhere along the connector lumen, specifically, close to the proximal end and the perforating tip; an inflation lumen, operably coupled in concentric manner to the rigid connector lumen having an open distal end and a closed proximal end, the inflation lumen defining at least one inflation aperture at the proximal end, wherein the rigid tube extends beyond the closed proximal end of the inflation lumen; a grasping member having an open distal end and a proximal end, the proximal end operably coupled to the distal end of the connector lumen, wherein the grasping member having a connector tube therethorough and an inflation tube fitting, in fluid communication with the inflation lumen; a distensible sheath having a distal end and a proximal end, disposed between the perforating tip of the rigid connector at its proximal end, and
  • a pump can be coupled to the inflation tube providing the operator with the means for pressurizing inflating fluid for suitably inflating a segment of the distensible sheath operably coupled at the proximal segment of the VOD.
  • the dimensions of the inflated segment can be configured to be fully encased within the lumen of the targeted vessel or duct through which blocking the flow of body fluid is to be accomplished, regardless of the angle of penetration of the vessel sought to be occluded.
  • the distensible sheath used in the vascular occlusion device (VOD) described herein can be formed of a resilient, ductile material (in other words, a material that is compliant or flexible or otherwise capable of elastic deformation) configured to undergo elongation of between 0.0 and about 2,000%.
  • the term "distensible”, as used herein, describes a property of the sheath used in the vascular occlusion device (VOD) described herein, as being a substantially compliant elastic material whereby the material considerably stretches as a result of an applied tensile stress, which regains its original or deformed shape when the applied tensile stress is removed.
  • the distensible sheath can be made of a biocompatible material.
  • biocompatible refers in an embodiment to a substance that can be in contact with biological material such as blood and tissue, without inducing adverse reactions, such as undesired inflammatory reactions or toxicity. Biocompatibility is naturally highly desirable for any embodiment of the vascular occlusion device described herein.
  • the sheath can be, for example formed of; a poly(ethylene-vinyl acetate), resilin, elastin, polyisoprene, a butyl rubber, a halogenated butyl rubber, polybutadiene, a styrene-butadiene copolymer, an acrylonitrile-butadiene copolymer, a hydrogenated acrylonitrile-butadiene copolymer, polychloroprene, an ethylene-propylene copolymer, an ethylene-propylene-diene copolymer, an atactic polypropylene, a low-density polyethylene, a polymer or copolymer of epichlorohydrin, a polyacrylic rubber, a silicone rubber, a fluorosilicone rubber, a fluoroelastomer, a
  • perfluoroelastomer a chlorosulfonated polyethylene, a chlorinated polyethylene, a polyurethane rubber, a polysulfide rubber, a polyphosphazene, polynorbornene, an ethylene-acrylate copolymer.
  • the polymers listed hereinabove are intended to encompass derivatives, stereoisomers, copolymers and blends of the foregoing polymers.
  • the sheath can be maintained under tensile stress when in the deflated state. It would be appreciated that there may be many ways to ensure that upon deflating, the distensible sheath will not "bunch" behind the vessel's internal wall. For example, vacuum can be applied to the inflating lumen during the deflation of the sheath.
  • the distensibility of the sheath (in other words, ductility, or the ability to vary ultimate balloon diameter over a large range of axial lengths), can assure complete and effective occlusion of vessels with irregular internal shape, for example, sclerotic veins and/or arteries and other blood vessels or similarly obstructed body lumens. Likewise, the efficiency of occlusion can be less sensitive to the angle of insertion to the vessel.
  • the blood vessel wall acts as a limiting feature to the distensible sheath's inflation. Therefore, regardless of the diameter of the vessel, the distensible sheath will only expend to the wall without exerting axial strain on the vessel wall. Moreover, the possibility of device migration is substantially eliminated, due to direct and continuous coupling to the blood vessel endothelium.
  • the perforating tip used in the vascular occlusion device (VOD) described herein can be comprised of an inverted sheath fold.
  • the sheath can be operably coupled (e.g., by an adhesive, fusing, and the like) close to the open proximal end of the rigid connector such that the sharpened tip of the proximal end in one embodiment, extends into the sheath to the distance defining the desired size of the perforating tip with the elongated connector lumen extending outside the sheath, the inverting the sheath, exposing the perforating, sharpened tip at the proximal end of the rigid connector, and covering the rigid connector and the proximal, sealed end of the concentric (i.e.
  • inflating lumen operably coupling the distensible sheath to the proximal tip of the grasping member.
  • the inverted sheath fold thus creating a substantially continuous surface between the distensible sheath and the perforating tip at the proximal end of the connector lumen.
  • Coupled refers to and comprises any direct or indirect, structural coupling, connection or attachment, or adaptation or capability for such a direct or indirect structural or operational coupling, connection or attachment, including integrally formed components and components which are coupled via or through another component or by the forming process.
  • Indirect coupling may involve coupling through an intermediary member or adhesive, or abutting and otherwise resting against, whether frictionally or by separate means without any physical connection.
  • ductile used herein in accordance with common usage in the art to refer to materials that exhibit significant elongation before break and/or shear yielding in response to an applied force or load during a tensile exposure. In other words, the term
  • ductile refers to materials capable of undergoing substantial deformation, e.g., during processing without breaking, for example, an elastic elongation of between 0 and about 2000%.
  • the distensible sheath can be operably coupled to the connector lumen at the proximal end of both the distensible sheath and the connector lumen as described above, however, with its length covering the connector lumen and the concentrically disposed inflating lumen.
  • a collar member can be operably coupled to the connector lumen and the distensible sheath, effectively smoothing the difference in the diameters between the sheath covered section of the connector lumen and the sheath covered inflation lumen.
  • the guidewire used in the vascular occlusion device (VOD) described herein can extend through the connector lumen, terminating in a sharpened tip, creating a perforating cone.
  • the connector lumen can be machined to provide a continuous surface with, for example a conical tip of the guidewire, while the continuity of the surface smoothing due to the difference in the diameters between the sheath covered section of the connector lumen and the sheath covered inflation lumen, can be provided by either a collar member or the inverted fold sheath as described above.
  • the perforating tip used in the vascular occlusion device (VOD) described herein, can further comprising a lancer operably coupled thereto.
  • the term "lance” is a broad term and is used in its ordinary sense and refers, without limitation, to any device which is suitable for causing bodily fluids, or other sample tissue to pass through the walls of a lumen in the body.
  • the lancer may comprise a solid needle, hollow needle, laser lance, iontophoretic device, conventional sharp lance, or any other suitable piercing or sample extractor device.
  • the size and configuration of the lancing member i.e., lancer
  • the lancer can be removable and be configured to engage the perforating tip used in the vascular occlusion device (VOD) described herein.
  • VOD vascular occlusion device
  • the vascular occlusion device described herein can further comprise a pump, for example, a peristaltic pump, or a hypodermic, in fluid communication (in other words; plumbed together, or receiving fluid from one to the other) with the inflation tube.
  • a pump for example, a peristaltic pump, or a hypodermic
  • fluid communication in other words; plumbed together, or receiving fluid from one to the other
  • the term "fluid communication,” as used herein refers to both direct and indirect fluid communication.
  • the pump used in conjunction with the vascular occlusion device (VOD) described herein can further comprise a check valve, a shut-off valve, a stopcock, a relief valve or a combination comprising one of the foregoing, operably coupled between the pump and the inflation tube.
  • the inflation tube can be formed of light-weight, resilient and biocompatible material, which, unlike clamps used currently, will be less traumatic and encumbering to a patient during surgery.
  • the inflation lumen can have a variable length and diameter, which may depend on the particular inflating fluid used (e.g., water, saline, and the like).
  • vascular occlusion devices described herein are used in the methods provided herein. Accordingly, and in an embodiment, provided herein is a method of reversibly occluding a fluid flow in a body lumen at a predetermined occlusion site inside said body, comprising the steps of: providing a vascular occlusion device comprising: a rigid connector lumen having a proximal end and a perforating tip proximal end; an inflation lumen, operably coupled to the rigid connector lumen having an open distal end and a closed proximal end, the inflation lumen defining at least one inflation aperture at the proximal end, wherein the rigid tube extends beyond the closed proximal end of the inflation lumen; a grasping member having an open distal end and a proximal end, the proximal end operably coupled to the distal end of the connector lumen, wherein the grasping member defining a connector tube therethorough and an inflation tube
  • the step of sealing the luer fitting implemented in the methods of reversibly occluding a fluid flow in a body lumen at a predetermined occlusion site can be, for example preceded, or followed in another example, by a step of: using a stopcock, closing the flow of an inflating fluid into the inflation tube.
  • the closing of the fluid can allow disengaging the pump when necessary, or to make the occlusion last for as long as necessary.
  • the inflating fluid e.g., saline solution
  • the methods of reversibly occluding a fluid flow in a body lumen at a predetermined occlusion site can further comprising deflating the distensible sheath; and removing the connector lumen from the body lumen, thereby reestablishing the fluid flow in the body lumen.
  • Deflating the distensible sheath can further comprise a step of opening the luer cap, to , for example, monitor and establish flow of the body fluid in the body lumen.
  • the step of deflating the distensible sheath can be carried out by opening the stopcock, and optionally, reversing the pump direction, pulling the inflating fluid to the point where the body fluid exits the distal end of the grasping member.
  • the methods of reversibly occluding a fluid flow in a body lumen at a predetermined occlusion site can be implemented at two sites along the same body lumen, for example during the removal of an arteriosclerotic portion of a blood vessel.
  • FIG. are merely schematic representations based on convenience and the ease of demonstrating the present disclosure, and are, therefore, not intended to indicate relative size and dimensions of the devices or components thereof, their relative size relationship and/or to define or limit the scope of the exemplary embodiments.
  • cross sections are referred to on normal orthogonal coordinate system having XYZ axis, such that Y axis refers to front-to-back, X axis refers to side-to-side, and Z axis refers to up-and-down.
  • VOD 10 comprising: rigid connector lumen 220 (FIG. 2) having a proximal end and a perforating tip 250 proximal end.
  • rigid connector lumen 220 is illustrated of an indeterminate length. As illustrated, the length of rigid connector lumen can be varied based on its intended use. Likewise, the diameter of rigid connector lumen 220 can be varied based inter-alia on the diameter of the lumen sought to be occluded, the type and viscosity of the inflating liquid, desired rate of sheath inflation, intended use (e.g., GSW Occlusion, colorectal cancer tumor removal, intestinal adhesion, vascular bypass)
  • GSW Occlusion colorectal cancer tumor removal
  • intestinal adhesion vascular bypass
  • Inflation lumen 230 (FIG. 3), operably coupled to rigid connector lumen 220 having an open distal end and a closed proximal end, inflation lumen 230, FIG. 3, defining at least one inflation aperture 235 at the proximal end.
  • inflation lumen 230 can define a plurality of aperture along the longitudinal axis of inflation lumen 230, such that perforation of a vessel through both vessel walls, will still inflate the sheath inside the vessel.
  • Rigid connector lumen 220 is configured to extend beyond the closed proximal end of inflation lumen 230, providing the surface for coupling distensible sheath 200.
  • Grasping member 100 is configured to have an open distal end with, for example, luer fitting 110 and a proximal tip 120 for providing, for example, structural integrity to grasping member 100.
  • the proximal end of the grasping member 100 is configured to be operably coupled to the distal end of connector lumen 220.
  • Grasping member 100 defines connector tube therethorough (not shown, see e.g., element 150, FIG. 13) and an inflation tube fitting (not shown, see e.g., element 130, FIG 13), in fluid communication with inflation lumen 230.
  • Distensible sheath 200 has a distal end and a proximal end, and is disposed between perforating tip 250 of rigid connector 220 at its proximal end, and the proximal end of grasping member 100 at its distal end.
  • inflation tube 300 (shown as having indeterminate length), can be operably coupled to inflation tube fitting (not shown, see e.g., element 130, FIG 13) in grasping member 100.
  • Luer fitting 110 can be coupled to the distal end of grasping member 100.
  • luer cap 400 configured to seal the open distal end of grasping member 100 by coupling with luer fitting 110.
  • distal end refers to a portion of the VOD that is inserted into a body during a procedure and that then becomes located in the region of interest.
  • proximal end refers to a VOD portion that is opposite from the distal end, including a portion that remains exterior to the body during use.
  • FIG. 2 showing the proximal end of VOD 10, showing connector lumen 220 having a sharpened end with sheath fold 210 terminating in seam 215, marking the closed proximal end of inflation lumen 230 (FIG. 3).
  • sheath 200 can be operably coupled (e.g., by an adhesive, fusing, and the like) to the section of rigid connector 220 extending beyond inflation lumen 230, such that sheath 200 extends beyond perforating tip 250.
  • the short sheath 200 section overlapping the proximal end terminus of rigid connector 220 can then be inverted and coupled to sheath coupling zone 211.
  • Inverted sheath fold 210 can thus create a substantially continuous surface between distensible sheath 200 and perforating tip 250 at the proximal end of connector lumen 220. Also shown is guide wire 450 having a blunt tip. As shown VOD 10 will not have a perforating tip and thus can be safely used in, for example, aneurism occlusions, traumatic injuries to body organs/lumens and the like. [00044] Turning now to FIG.s 4 -6, showing VOD 10 in its inflated state where a pump (not shown) inserts inflating fluid into inflation lumen 230 via inflation tube 300 (FIG. 1), causing distensible sheath 200 to inflate, forming a prolate ellipsoid (FIG. 4) with perforating tip extending beyond the pole of the inflated sheath 200 (Fig. 5).
  • a pump not shown
  • FIG.s 7-9 showing another embodiment of VOD 10, wherein , distensible sheath 200 can be operably coupled (e.g., by an adhesive, fusing, and the like) close to the open proximal end of rigid connector 220, forming coupling zone 211 (FIG.
  • proximal end of guidewire 450 (FIG. 1) is rounded/blunt and no perforating tip 250 exists. This embodiment can be used for example, to occlude aneurism or perforation in body vessels due to traumatic injury, such as shrapnel, knife stabbings and gunshot wounds.
  • FIG.s 10 and 11 illustrating yet another embodiment of VOD 10, where, guidewire 450 can extend through connector lumen 220, terminating in a sharpened tip, creating a perforating cone.
  • Rigid connector lumen 220 can be machined to provide a continuous surface with, for example a conical tip of guidewire 450, while the continuity of the surface smoothing due to the difference in the diameters between distensible sheath 200 covered section of rigid connector lumen 220 and distensible sheath 200 covered inflation lumen 230 (FIG. 11), can be provided by either collar member 240 or inverted fold sheath 210 as illustrated in FIG.s 1-6.
  • Guidewire 450 can be perforating (as shown on Fig. 11) for initial perforation and then be partially retracted so perforating tip 250 becomes blunt, incapable of perforating anything else.
  • Rigid connector lumen 220 (which can be curved) can extend beyond the closed proximal end of the inflation lumen (not shown, see e.g., element 230 FIG. 11); grasping member 100 having an open distal end having a luer fitting 110 coupled thereto and a proximal end tip 120, proximal end tip operably coupled to the distal end of connector lumen 220, wherein grasping member defining connector tube 150 (FIG. 14) therethorough and inflation tube fitting 130, in fluid communication with inflation lumen 130 (FIG.
  • distensible sheath 200 having a distal end and a proximal end, disposed between perforating tip 250 of rigid connector 220 at distensible sheath's proximal end, and the proximal tip 120 of grasping member 100 at its distal end; inflation tube 300, operably coupled to inflation tube fitting 130 in grasping member 100; a luer fitting 110 coupled to the distal end of grasping member 100; luer cap 400, configured to seal the open distal end of grasping member 100; and guidewire 450, operably coupled to luer cap 400, configured to extend at least partially through rigid connector lumen 220.
  • FIG.s 14 and 15 illustrating in FIG. 14 a X-Y cross section of an embodiment of the use of the vascular occluding devices (VOD) 10 described herein in which the VOD penetrates both vessel walls and a Y-Z cross section illustration in FIG. 15 of another embodiment of the use of the vascular occluding devices (VOD) described herein in which the VOD penetrates both walls in an arteriosclerotic vessel.
  • VOD 10 comprising: rigid connector lumen having a proximal end and a perforating tip proximal end; an inflation lumen, operably coupled to the rigid connector lumen having an open distal end and a closed proximal end, the inflation lumen defining at least one inflation aperture at the proximal end, wherein the rigid tube extends beyond the closed proximal end of the inflation lumen; a grasping member having an open distal end and a proximal end, the proximal end operably coupled to the distal end of the connector lumen, wherein the grasping member defining a connector tube therethorough and an inflation tube fitting, in fluid communication with the inflation lumen; a distensible sheath having a distal end and a proximal end, disposed between the perforating tip of the rigid connector at its proximal end, and the proximal end of the grasping member at its distal end; an inflation tube, operably coupled to the inflation tube fitting in the grasping member;
  • a pump (not shown, e.g., hypodermic equipped with a stopcock), operably coupled to inflating tube 300 (not shown, see e.g., FIG. 1), pumping an inflating fluid thereby inflating distensible sheath 200 to the extent necessary to stop fluid flow in body lumen 500.
  • luer cap 400 sealing the luer fitting, thereby reversibly occluding a fluid flow in body lumen 500 at a predetermined site inside the body.
  • distensible sheath By monitoring bodily fluid flow through distal end 150 during the inflation of distensible sheath, the physician can ensure the pressure used to occlude flow will not be beyond the necessary. As shown, insertion angle of VOD 10 does not have to be normal to the longitudinal axis of body lumen 500 to be effective. Likewise, due to the highly distensible nature of sheath 200, inflating distensible sheath 200 inside arteriosclerotic body lumen 500can achieve full occlusion regardless of the irregular diameter of the endothelium, as well as reduce the risk of releasing plaque from the sclerotic area to the blood stream.
  • FIG. 16 illustrating a X-Y cross section illustration of yet another embodiment of the use of a couple of the vascular occluding devices (VOD) described herein in which the VODs penetrate one vessel wall at two locations, isolating a treatment zone.
  • VOD vascular occluding devices
  • full occlusion can be attained regardless of the insertion angle.
  • the methods provided can allow for treating the isolated zone between the occlusion sites, by, for example, but not limited to, cutting, resecting, boring, or other surgical treatment comprising one or more of the foregoing.
  • VODs as disclosed and claimed herein provide for blocking the flow of fluids of vessel or ducts within a mammalian body. Furthermore VODs as disclosed and claimed herein can be employed for sealing off perforations in a wall of a natural cavity such as the thorax. For example in emergency in which a thoracic injury such as caused by stabbing and or gun-shot can be sealed off by placing the proximal segment of the VOD such as the one described with reference to Figs 14- 16.
  • water can be pressurized into the inflation tube such that a portion of the distensible sheath expands within the thoracic cavity, another portion of the distensible sheath can expand outside of the patient's body and the mid segment of the distensible sheath that is disposed at the lumen of the perforation of the thoracic sidewall fully fills in this perforation.
  • Tubular/lumens/annular members of VODs as disclosed and claimed herein are manufactured according to the present invention from biocompatible materials such as those utilized for manufacturing catheters and cannulas normally employed for medical care procedures.
  • the distal segment of the inflation tube is somewhat elastic such that it is easily bended while being introduced into the lumen of a blood vessel to follow its natural curvature and geometrical shape.
  • Elastic straps can be manufactured from thermoplastic resins such as polyurethane.
  • the sharpened tip of the inflation tube can be manufactured of stainless steel.
  • the lengths and radii of tubular members of VODs can be selected in accordance with the targeted vessels to be blocked by means of such VODs. There is no need to block the flow of body fluids through the targeted duct or vessel prior to introducing therein a VOD described herein.
  • the same VOD can be reused at the same site or at various different sites. Therefore VODs described herein are suited for cases of emergency.
  • the VOD is fixed to the sidewall of the targeted vessel by being anchored to at least one perforation through which a segment of the respective VOD enters the lumen.
  • the same VOD can be used to block the flow through a variety of vessels having a range of diameters.
  • the distensible sheath can have widths exceeding the maximal length of the vessels' or ducts' diameters. Therefore there is no maximal limit to the dimensions of the inflated segment of the inflation tube that is inwardly disposed within the vessel considered.
  • the tubular members are pre-shaped either linearly or arcuate. Nevertheless the elasticity of the inflation tube is such that it can be easily curved within the targeted vessel to follow its natural curvature.
  • the suffix "(s)" as used herein is intended to include both the singular and the plural of the term that it modifies, thereby including one or more of that term (e.g., the VOD(s) includes one or more VOD).
  • Reference throughout the specification to "one embodiment”, “another embodiment”, “an embodiment”, and so forth, means that a particular element (e.g., feature, structure, and/or characteristic) described in connection with the embodiment is included in at least one embodiment described herein, and may or may not be present in other embodiments.
  • the described elements may be combined in any suitable manner in the various embodiments.
  • a Vascular Occlusion Device comprising: a rigid connector lumen having a distal end and an, open proximal end with a perforating tip; an inflation lumen, operably coupled to the rigid connector lumen having an open distal end and a closed proximal end, the inflation lumen defining at least one inflation aperture at the proximal end, wherein the rigid tube extends beyond the closed proximal end of the inflation lumen; a grasping member having an open distal end and a proximal end, the proximal end operably coupled to the distal end of the connector lumen, wherein the grasping member defining a connector tube therethorough and an inflation tube fitting, in fluid communication with the inflation lumen; a distensible sheath having a distal end and a proximal end, disposed between the perforating tip of the rigid connector at its proximal end, and the proximal end of the grasping member at its dis
  • a method of reversibly occluding a fluid flow in a body lumen at a predetermined occlusion site inside said body comprising the steps of: providing a vascular occlusion device comprising: a rigid connector lumen having a proximal end and a perforating tip proximal end; an inflation lumen, operably coupled to the rigid connector lumen having an open distal end and a closed proximal end, the inflation lumen defining at least one inflation aperture at the proximal end, wherein the rigid tube extends beyond the closed proximal end of the inflation lumen; a grasping member having an open distal end and a proximal end, the proximal end operably coupled to the distal end of the connector lumen, wherein the grasping member defining a connector tube therethorough and an inflation tube fitting, in fluid communication with the inflation lumen; a distensible sheath having a distal end and a

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  • 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)
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Abstract

L'invention concerne un dispositif d'occlusion vasculaire (VOD). Plus particulièrement, l'invention concerne des dispositifs d'occlusion vasculaire ayant une gaine dilatable apte à obtenir une forme sphéroïde allongée ayant un axe polaire variable, muni d'une pointe d'exécution d'une seule pièce, apte à bloquer efficacement temporairement et de façon réversible un écoulement de fluide dans des vaisseaux corporels de diamètres et formes variables.
PCT/IL2013/000087 2012-11-30 2013-12-01 Dispositif d'occlusion vasculaire et procédés d'utilisation WO2014083559A1 (fr)

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US201261731534P 2012-11-30 2012-11-30
US61/731,534 2012-11-30

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108852459A (zh) * 2018-07-25 2018-11-23 深圳市远为医疗技术有限公司 一种可塑形多功能颅脑造通器
WO2020090437A1 (fr) * 2018-10-30 2020-05-07 クリエートメディック株式会社 Cathéter

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3833003A (en) * 1972-07-05 1974-09-03 A Taricco Intravascular occluding catheter
US6176851B1 (en) * 1996-05-14 2001-01-23 Embol-X, Inc. Cardioplegia occluder
US6248121B1 (en) * 1998-02-18 2001-06-19 Cardio Medical Solutions, Inc. Blood vessel occlusion device

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3833003A (en) * 1972-07-05 1974-09-03 A Taricco Intravascular occluding catheter
US6176851B1 (en) * 1996-05-14 2001-01-23 Embol-X, Inc. Cardioplegia occluder
US6248121B1 (en) * 1998-02-18 2001-06-19 Cardio Medical Solutions, Inc. Blood vessel occlusion device

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108852459A (zh) * 2018-07-25 2018-11-23 深圳市远为医疗技术有限公司 一种可塑形多功能颅脑造通器
CN108852459B (zh) * 2018-07-25 2024-01-30 深圳市远为医疗技术有限公司 一种可塑形多功能颅脑造通器
WO2020090437A1 (fr) * 2018-10-30 2020-05-07 クリエートメディック株式会社 Cathéter
JP2020068990A (ja) * 2018-10-30 2020-05-07 クリエートメディック株式会社 カテーテル
CN112930165A (zh) * 2018-10-30 2021-06-08 库利艾特梅迪克株式会社 导管
JP7160633B2 (ja) 2018-10-30 2022-10-25 クリエートメディック株式会社 カテーテル
CN112930165B (zh) * 2018-10-30 2024-04-05 库利艾特梅迪克株式会社 导管

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