EP2967808A1 - Dispositif d'angioplastie transluminale percutanée avec filtre embolique intégré - Google Patents

Dispositif d'angioplastie transluminale percutanée avec filtre embolique intégré

Info

Publication number
EP2967808A1
EP2967808A1 EP14768559.8A EP14768559A EP2967808A1 EP 2967808 A1 EP2967808 A1 EP 2967808A1 EP 14768559 A EP14768559 A EP 14768559A EP 2967808 A1 EP2967808 A1 EP 2967808A1
Authority
EP
European Patent Office
Prior art keywords
ring
filter
catheter
scaffolding
distal
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.)
Withdrawn
Application number
EP14768559.8A
Other languages
German (de)
English (en)
Other versions
EP2967808A4 (fr
Inventor
Ravish Sachar
Udayan G. Patel
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.)
Contego Medical Inc
Original Assignee
Contego Medical Inc
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
Priority claimed from US13/838,523 external-priority patent/US20170007390A9/en
Application filed by Contego Medical Inc filed Critical Contego Medical Inc
Publication of EP2967808A1 publication Critical patent/EP2967808A1/fr
Publication of EP2967808A4 publication Critical patent/EP2967808A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/013—Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
    • 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
    • A61M25/10—Balloon catheters
    • A61M25/104—Balloon catheters used for angioplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/016—Filters implantable into blood vessels made from wire-like elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/018—Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/005—Rosette-shaped, e.g. star-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0029—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in bending or flexure capacity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • 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
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics
    • 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

Definitions

  • Implementations described herein relate generally to surgical devices and relate more specifically to percutaneous transluminal angioplasty devices.
  • the vascular bed supplies a constant flow of oxygen-rich blood to the organs.
  • Diseased vessels In diseased vessels, blockages can develop that can reduce blood flow to the organs and cause adverse clinical symptoms up to and including fatality.
  • Diseased vessels can comprise a range of material from early-stage thrombosis to late-stage calcified plaque.
  • Angioplasty can be described as a catheter-based procedure performed by a physician to open up a blocked vessel and restore blood flow.
  • An entry site can be opened, for example, in the patient's groin, arm, or hand, and a guide wire and catheter can be advanced under fluoroscopic guidance to the location of the blockage.
  • a catheter having a small balloon adjacent its distal end can be advanced under fluoroscopic guidance until the balloon lies within the stenosed region.
  • the balloon can be then inflated and deflated one or more times to expand the stenosed region of the artery.
  • Angioplasty can release embolic particles down-stream from the stenosed location. These embolic particles can result in adverse clinical consequences. It has been shown beneficial to trap these embolic particles to prevent them from traveling downstream with blood flow to the capillary bed (e.g., Baim D S, Wahr D, George B, et al, Randomized trial of a distal embolic protection device during percutaneous intervention of saphenous vein aorto-coronary bypass grafts, Circulation 2002; 105: 1285-90).
  • stenoses can also be treated with stents and with mechanical atherectomy and thrombectomy devices. These devices can be also prone to releasing embolic particles downstream from the stenosed location.
  • a filter scaffolding configured to support a filter membrane is mounted at the distal end of the filter guidewire.
  • the filter scaffolding is movable between a retracted position, in which the scaffolding lies against the guidewire for insertion and retraction of the guidewire in the patient's body, and an expanded position in which the filter medium expands across substantially the entire vessel.
  • the prior art filter guidewire is inserted through the main lumen of the angioplasty catheter and advanced to a "landing zone" distal to the stenosis. The filter guidewire is then manipulated to deploy a filter scaffolding having a filter medium attached and configured to capture any emboli released by the angioplasty procedure.
  • This distance can be a problem not only in distal vein graft lesions, but also in arterial stenoses in which there can be a side branch immediately after the stenosis, such as native coronary arteries.
  • the filter can often be deployed only distal to the side branch, thus leaving the side branch unprotected from embolic particles.
  • the present disclosure comprises a percutaneous transluminal angioplasty device with integral embolic filter. Because the filter can be integral with the catheter of the angioplasty device, any need to insert a separate device into the vessel can be eliminated. Further, proper placement of the angioplasty balloon can assure proper placement of the embolic filter.
  • the present disclosure comprises a catheter having an elongated shaft, proximal and distal ends, a longitudinal axis and a filter.
  • the filter comprises a first ring coaxially fixedly mounted on a distal portion of the catheter shaft, a second ring coaxially slidably mounted on a distal portion of the catheter shaft and configured to be moved toward and away from the first ring and a scaffolding extending between the first and second rings.
  • the scaffolding further comprises a plurality of first longitudinal connecting members, each having a first end attached to the first ring and a second end extending toward the second ring; a plurality of second longitudinal connecting members, each having a first end attached to the second ring and a second end extending toward the first ring.
  • Each of the first and second longitudinal connecting members further comprise a bifurcation formed on the second end thereof, each of the bifurcations comprising first and second branches; and a means for connecting a branch on each of the plurality of first longitudinal connecting members to a branch on an opposite one of the plurality of second longitudinal connecting members.
  • the filter further comprises a membrane connected to at least the scaffolding.
  • FIG. 1 illustrates a side view of one aspect of an angioplasty device with integral embolic filter.
  • FIG. 2A illustrates a cross-section of the proximal end of the angioplasty device with integral embolic filter shown in FIG. 1 ; and FIG. 2B illustrates a cross-section of the distal end of the device shown in FIG. 1.
  • FIG. 3 illustrates a schematic view of one aspect of a filter scaffolding of the angioplasty device of FIG. 1, showing the filter scaffolding in an un-deployed position.
  • FIG. 4 illustrates a schematic view of the filter scaffolding of FIG. 3, showing the filter scaffolding in a deployed position.
  • FIG. 5 illustrates a schematic view of another aspect of a filter scaffolding of the angioplasty device of FIG. 1, showing the filter scaffolding in an un-deployed position.
  • FIG. 6 illustrates a schematic view of the filter scaffolding of FIG. 5, showing the filter scaffolding in a deployed position.
  • FIG. 7 illustrates a schematic view of a third aspect of a filter scaffolding of the angioplasty device of FIG. 1, showing the filter scaffolding in an un-deployed position.
  • FIG. 8 illustrates a schematic view of the filter scaffolding of FIG. 7, showing the filter scaffolding in a deployed position.
  • FIG. 9 illustrates a blood vessel having a stenosis.
  • FIG. 10 illustrates the blood vessel with stenosis of FIG. 9 with the angioplasty device of FIG. 1 positioned therein.
  • FIG. 1 1 illustrates the blood vessel and angioplasty device of FIG. 10 with the integral embolic filter expanded.
  • FIG. 12 illustrates the blood vessel and angioplasty device of FIG. 10 with the angioplasty balloon and integral embolic filter deployed.
  • FIG. 13 illustrates the blood vessel and angioplasty device of FIG. 10 after treatment of the stenosis, with the angioplasty balloon in its un-deployed position and the embolic filter still in its deployed position.
  • FIG. 14 illustrates the blood vessel and angioplasty device of FIG. 10 after treatment of the stenosis, with both the angioplasty balloon and embolic filter in an un- deployed position in preparation for withdrawal of the device from the vessel.
  • FIG. 15 illustrates an alternate aspect of a filter scaffolding comprising a sinusoidal frame.
  • FIG. 16 illustrates one aspect of the attachment of the sinusoidal frame.
  • FIG. 17 illustrates a side view of another aspect of an angioplasty device with integral embolic filter where the treatment device lies distal to the filter.
  • FIG. 1 illustrates a first aspect of an angioplasty catheter with integral embolic filter 10 according to the present invention.
  • the angioplasty catheter with integral embolic filter 10 comprises an elongated catheter 12 having a shaft 14 with a proximal end 16 and a distal end 18.
  • proximal refers to the portion of the device closest to the physician performing the procedure
  • distal refers to the portion of the device that is furthest from the physician performing the procedure.
  • An angioplasty treatment device 20 can be mounted to the catheter 12 at a location near the distal end 18 of the catheter shaft 14.
  • Angioplasty treatment devices comprise, for example and without limitation, inflatable balloons, expandable stents, atherectomy and thrombectomy devices and the like.
  • An embolic filter 30 can be mounted to the catheter shaft 14 at a location distal to the angioplasty treatment device 20 and at or proximal to the distal end 18 of the catheter 12. As illustrated in Figure 17, it is also contemplated that the embolic filter 30 can be mounted to the catheter shaft 14 at a location proximal to the treatment device 20. In additional or alternative embodiments, the filter 30 can be oriented to face towards or away from the treatment device.
  • the angioplasty catheter can be configured to be, for example and without limitation, an over-the-wire catheter, a rapid-exchange catheter and the like. It is solely for clarity of disclosure that the present description describes an over-the-wire catheter modality.
  • the catheter shaft 14 can define three lumens: a main lumen 32, an angioplasty balloon inflation lumen 34, and an embolic filter actuator wire lumen 36.
  • the main lumen 32 can extend from the proximal end 16 to the distal end 18 of the catheter shaft 14.
  • the main lumen 32 can optionally provide a working channel and be configured to receive a guidewire therethrough for advancing the distal end 18 of the catheter 12 through the patient's vasculature to a treatment site.
  • treatment site refers to the location of the occlusion within the patient's vasculature, and when the catheter 12 is referred to as being located or positioned at the treatment site, it will be understood to mean that the catheter is positioned such that the angioplasty treatment device 20 is located within the occlusion.
  • the balloon inflation lumen 34 can extend from a proximal port 38 at the proximal end 16 of the catheter 12 and through the catheter shaft 14 to a distal port 40 located within the angioplasty treatment device 20.
  • the actuator wire lumen 36 can extend from a proximal port 44 at the proximal end 16 of the catheter 12 and through the catheter shaft 14 to a distal port 46 distal to the angioplasty treatment device 20.
  • the embolic filter 30 comprises a filter membrane 50 (FIG. 12) having holes selectively sized to permit the passage of blood but to capture particles larger than normal blood particles and a collapsible scaffolding 52 for supporting the filter membrane.
  • the drawing figures omit the filter membrane 50 when illustrating the scaffolding 52, but it will be understood that all embolic filters disclosed in this application comprise a filter membrane supported by the scaffolding.
  • the scaffolding 52 can include a proximal ring 56 and a distal ring 54.
  • both of the rings can be located between the distal end of the angioplasty treatment device 20 and the distal end 18 of the catheter shaft.
  • the distal ring 54 can be fixed in place on the catheter shaft 14, and the proximal ring 56 can be slidably mounted to the catheter shaft for axial movement in the proximal and distal directions.
  • Each of a plurality of first strut sections 60 can have a first end 62 and a second end 64.
  • the first end 62 of each first strut section 60 can be attached to the distal ring 54, and each first strut section can extend in the proximal direction.
  • each of a corresponding plurality of second strut sections 70 can have a first end 72 and a second end 74.
  • the first end 72 of each second strut section 70 can be attached to the proximal ring 56, and each second strut section can also extend in the proximal direction.
  • the plurality of second strut sections 70 can be replaced with a sinusoidal ring structure 55 as illustrated in Figures 15-16.
  • the sinusoidal ring 55 contracts radially inward as the relative distance between the distal and proximal rings increases and expands as the relative distance between the distal and proximal rings decreases.
  • each first strut section 60 can attach to the second end 74 of a corresponding second strut section 70.
  • each connected first and second strut section 60, 70 collectively comprises a strut 80.
  • a plurality of strut 80 can be spaced circumferentially about and connecting the proximal and distal rings to form the scaffolding 52. In operation and as shown in FIG. 3, when the proximal and distal rings 56, 54 are adjacent one another each strut 80 can be configured to fold back upon itself.
  • the struts 80 can be configured to open in a manner similar to an umbrella.
  • the filter membrane 50 can be supported on the first strut sections 60 such that when the scaffolding 52 opens, as shown in FIG. 4, the filter membrane can deploy in a manner similar to an umbrella canopy.
  • each strut can further comprise at least one "zone of weakness," i.e., a zone of the strut that can be configured to be physically weaker than the majority of the strut in order to control the locations at which the struts bend.
  • the at least one zone of weakness can be formed in any of a number of ways. In one aspect, a notch can be formed in one or both sides of the strut. In another aspect, at least one of the upper surface and lower surface of the strut can be scored. In another aspect, the at least one zone of weakness can be formed of a material that can be structurally weaker than the material comprising the remainder of the strut.
  • the at least one zone of weakness can comprise mechanical hinges.
  • the apices of the sinusoidal ring 55 comprise a zone of weakness.
  • at least two of these approaches can be combined to form the at least one zone of weakness, e.g., both notching the width and scoring the depth of the strut.
  • the at least one zone of weakness can comprise a plurality of one type of physical arrangement, e.g., a single zone of weakness can comprise a plurality of notches or a plurality of scores.
  • the at least one zone of weakness can be configured to bend the strut in response to a force at a predetermined angle to the longitudinal axis of that portion of the strut.
  • movement of the proximal ring 56 toward and away from the distal ring 54 to open and to close the embolic filter 30 can be accomplished by manipulation of an actuator wire 84.
  • the proximal end 86 of the actuator wire 84 can extend out of the proximal port 44 of the actuator wire lumen 36 so as to be controllable by the physician performing the procedure.
  • the actuator wire 84 can extend through the actuator wire lumen 36 and can exit through the distal port 46 of the actuator wire lumen.
  • the distal end 88 of the actuator wire 84 can be attached to the proximal ring 56.
  • the filter scaffolding 52 and actuator wire 84 can be arranged to permit the embolic filter 30 to be opened and closed by moving the proximal end 86 of the actuator wire.
  • the filter scaffolding 52 can be formed in a normally closed or undeployed position. In operation, pulling the proximal end 86 of the actuator wire 84 can cause the proximal ring 56 to slide in a proximal direction to open the filter scaffolding 52.
  • the filter scaffolding can be configured so that releasing the tension on the actuator wire 84 and/or pushing the actuator wire 84 distally can permit the filter scaffolding 52 to collapse to an un-deployed position.
  • a filter scaffolding 152 can comprise a proximal ring 156 that can be fixed with respect to a catheter shaft 1 14 and a distal ring 154 that can be slidably positioned along the catheter shaft in the proximal and distal directions.
  • a distal port 146 of an actuator wire lumen 136 can be located distal to the proximal ring 156.
  • an actuator wire (not shown) can extend through the actuator wire lumen, can exit through a distal port 146, and can attach to the distal ring 154.
  • the filter scaffolding 152 can be formed in a normally closed position.
  • pushing the actuator wire 184 can displace the distal ring 154 in a distal direction away from the proximal ring 156 to deploy the filter scaffolding 152.
  • the filter scaffolding can be configured so that releasing the force on the actuator wire 184 and/or pushing the actuator wire 184 distally can permit the filter scaffolding 152 to return to its un- deployed position.
  • a proximal ring 254 can be fixed with respect to a catheter shaft 214, and a distal ring 256 can be slidably positioned along the catheter shaft in the proximal and distal directions.
  • a distal port 246 of an actuator wire lumen 236 can be located distal to the distal ring 256.
  • an actuator wire 284 can extend through the actuator wire lumen 236, can exit through the distal port 246, and can attach to the distal ring 256.
  • the filter scaffolding 252 can be formed in a normally closed position.
  • pulling on the actuator wire 284 can displace the distal ring 256 in a distal direction and away from the proximal ring 156 to deploy the filter scaffolding 252.
  • the filter scaffolding can be configured so that releasing the force on the actuator wire 284 can permit the filter scaffolding 252 to return to its un-deployed position.
  • FIGS. 3 and 4 another aspect of a filter scaffolding can be structurally identical to the first embodiment 52 except that the filter scaffolding can be formed in a normally open or deployed position.
  • application of a distally directed force to the proximal end 86 of the actuator wire 84 i.e., pushing the actuator wire
  • the filter scaffolding 52 can be permitted to expand to its normally deployed position, expanding the filter membrane 50, upon release of the force applied to the actuator wire 84.
  • a distally directed force can again be applied to the proximal end 86 of the actuator wire 84, moving the proximal ring 56 toward the distal ring 54 and collapsing the filter scaffolding 52.
  • a fifth aspect can be structurally identical to the third aspect with the exception that the filter scaffolding 152 can be formed in a normally open position.
  • the distal ring 154 can be normally displaced toward the distal end 18 of the catheter shaft 1 14.
  • pulling on the distal end 188 of the actuator wire 184 can move the distal ring 154 proximally toward the fixed proximal ring 156, collapsing the filter scaffolding 152 while releasing the tension on the actuator wire 184 can permit the filter scaffolding 152 to expand to its deployed position.
  • the force applied to the actuator wire is configured to be an axial compressive force
  • a stiffer wire can be used to prevent buckling of the actuator wire than in those embodiments where the force applied to the actuator wire is configured to be an axial tensile force.
  • wire is intended to comprise, for example and without limitation, metallic wires, polymeric wires, and the like.
  • polymeric wires the polymers used can comprise, for example and without limitation, nylon, polypropylene and the like.
  • the filter membrane 50 can be formed from at least one of a textile, a polymer and a wire mesh.
  • the filter membrane 50 comprises pores and, in a further aspect, the pores can be sized to allow blood to pass but not embolic particles. It is also contemplated that the filter membrane 50 can be mounted either on top of or inside of the frame.
  • the filter membrane 50 can be configured to cover the exterior surface of the outermost strut sections, i.e., the first strut sections 60, 160, and 260.
  • the filter membrane 50 can be further configured to extend beyond the distal or second ends 64, 164, and 264 of the first strut sections 60, 160, and 260, where it can be attached to the circumference of the distal ring 54, 156, 256.
  • the filter membrane 50 can optionally be configured to extend beyond the distal end of the distal ring and can be attached to the circumference of the catheter shaft 14 at a location between the distal ring 54 and the distal end 18 of the catheter shaft.
  • the filter membrane 50 in each of the disclosed embodiments can be attached to the inner surfaces of the first strut sections 60, 160, and 260 instead of to the outer surfaces.
  • the inner or second strut sections 70, 170, 270 can also be configured in a concave shape with respect to the blood flow when the filter scaffolding is deployed.
  • the filter membrane 50 can be attached to the inner or outer surfaces of the second strut sections 70, 170, 270.
  • the filter membrane 50 When the filter membrane 50 is attached to the surfaces of the second strut sections 70, 170, 270, the filter membrane 50 can optionally extend beyond the distal or second ends 74, 174, 274 of the second strut sections and be attached to the circumference of the proximal ring 56, 154, 254. It is also contemplated that, if the filter membrane 50 can be attached to the outer surfaces of the second strut sections 70 and the proximal ring 56 can be fixed, the filter membrane can be configured to extend beyond the distal end of the proximal ring and can be attached to the catheter shaft 14 at a location between the proximal and distal rings 56, 54.
  • the filter scaffolding comprises a fixed ring and a movable ring, raising the filter can be accomplished by moving the rings apart, and collapsing the filter can be achieved by moving the rings together.
  • "Moving apart” and “moving together” are used as relative terms, such that only one of the two rings need move with respect to the other ring for the rings to "move apart” or “move together.”
  • the process of raising and collapsing the filter can be thought of as being viewed from the perspective of the catheter, such that a movable ring can be moved toward or away from a fixed ring.
  • both actively applying a force to move a ring and releasing a force to permit the ring to move of its own accord comprise a step of "causing" the movable ring to move by "controlling" the actuator wire.
  • the actuator wire can be "controlled” to “cause” a movable ring to move, whether that control takes the form of applying or releasing a force on the actuator wire.
  • a control device can be associated with the proximal end of the actuator wire at the proximal end of the catheter shaft.
  • the control device can incorporate, for example and without limitation, levers, sliders, rotating spindles, or the like to facilitate movement of the wire.
  • levers, sliders, rotating spindles, or the like can be associated with the wire.
  • FIGS. 29-33 Use of the angioplasty device with integral embolic filter described above to treat a stenosis in a blood vessel can be shown in FIGS.
  • a vessel 500 can have a branch vessel 502 diverging from it.
  • the vessel 500 can have a stenosis 504.
  • the direction of blood flow through the vessel 500 is indicated by the arrow 506.
  • a guide wire 508 has been inserted by the physician as a preliminary step in the interventional procedure.
  • FIG. 10 shows the catheter 12 with angioplasty balloon 20 and embolic filter
  • the catheter 30 in their un-deployed positions and lying adjacent to the catheter shaft 14.
  • the distal end 18 of the catheter shaft 14 has been advanced over the guide wire 506 until the deflated angioplasty balloon 20 resides within the stenosis.
  • the catheter 12 With the catheter 12 positioned such that the angioplasty balloon 20 can be located within the stenosis, the catheter can be said to be at its "target site.” With the catheter at the target site, the portion of the vessel 500 occupied by the embolic filter 30 can be referred to as the "landing zone" 510.
  • the embolic filter 30 has been expanded by pulling on the actuator wire 84.
  • the angioplasty balloon 20 can be inflated and, if needed, deflated and re- inflated, optionally multiple times, to force the stenosis open.
  • embolic particles 510 are released and swept by the blood flow into the open proximal end of the embolic filter 30, where they are captured by the filter membrane 50.
  • the formerly stenosed region can be open, and the angioplasty balloon 20 has been deflated.
  • the embolic filter 30 remains open to capture any emboli released as the angioplasty balloon 20 deflates and pulls away from the wall of the vessel 500.
  • the embolic filter 30 can be closed, trapping captured emboli within the filter.
  • the catheter 12 can now be withdrawn from the vessel 500.
  • each of the disclosed embolic filters can be that, because the struts fold back on themselves, the filter scaffolding in its un-deployed position can be shorter than other known and/or commercially available embolic filters.
  • the shorter length can enable a shorter landing zone, which in turn can permit the filter to be placed closer to the angioplasty treatment means.
  • One result of providing a shorter landing zone can be a reduced likelihood that a branch blood vessel will intersect the stenosed blood vessel between the angioplasty treatment means and the embolic filter, thus reducing the chances of emboli bypassing the filter and getting caught up in the bloodstream.
  • the present disclosure permits the placement of the embolic filter very close to the means for treating the stenosis. This has the effect of minimizing the "landing area" of the filter and also permits the protection of side branches, as shown in FIGS. 22-25.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Biophysics (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne un dispositif d'angioplastie transluminale percutanée qui comprend un filtre embolique installé sur la tige de cathéter à un emplacement distal par rapport au ballonnet d'angioplastie. Par conséquent, le filtre peut être en aval de l'obstruction et peut être correctement positionné pour capturer des particules emboliques qui peuvent être libérées dans la circulation sanguine de sorte que la procédure d'angioplastie puisse être effectuée. Le filtre de protection embolique peut être normalement non déployé contre la tige du cathéter pour faciliter l'introduction et le retrait du dispositif dans et hors du site opératoire. Une fois le ballonnet d'angioplastie correctement positionné, des moyens fonctionnellement associés au filtre embolique peuvent être actionnés pour relever le filtre de manière à positionner une grille de filtration de part et d'autre de la lumière du vaisseau.
EP14768559.8A 2013-03-15 2014-03-07 Dispositif d'angioplastie transluminale percutanée avec filtre embolique intégré Withdrawn EP2967808A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US13/838,523 US20170007390A9 (en) 2004-11-24 2013-03-15 Percutaneous transluminal angioplasty device with integral embolic filter
PCT/US2014/021850 WO2014150013A1 (fr) 2013-03-15 2014-03-07 Dispositif d'angioplastie transluminale percutanée avec filtre embolique intégré

Publications (2)

Publication Number Publication Date
EP2967808A1 true EP2967808A1 (fr) 2016-01-20
EP2967808A4 EP2967808A4 (fr) 2017-01-25

Family

ID=51580687

Family Applications (1)

Application Number Title Priority Date Filing Date
EP14768559.8A Withdrawn EP2967808A4 (fr) 2013-03-15 2014-03-07 Dispositif d'angioplastie transluminale percutanée avec filtre embolique intégré

Country Status (7)

Country Link
EP (1) EP2967808A4 (fr)
JP (1) JP2016511086A (fr)
CN (1) CN105188605B (fr)
AU (1) AU2014237626A1 (fr)
BR (1) BR112015023627A8 (fr)
HK (1) HK1214495A1 (fr)
WO (1) WO2014150013A1 (fr)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9707071B2 (en) 2004-11-24 2017-07-18 Contego Medical Llc Percutaneous transluminal angioplasty device with integral embolic filter
US9510930B2 (en) 2008-10-22 2016-12-06 Contego Medical, Llc Angioplasty device with embolic filter
ES2617711T3 (es) 2013-03-15 2017-06-19 National University Of Ireland Un dispositivo adecuado para retirar materia del interior de un lumen y de la pared de un lumen corporal
EP3065668A4 (fr) * 2013-11-08 2017-09-27 Contego Medical, LLC Dénervation artérielle percutanée par cathéter à filtre embolique intégré
EP3017775A1 (fr) 2014-11-07 2016-05-11 National University of Ireland, Galway Dispositif de thrombectomie
WO2016112032A1 (fr) * 2015-01-05 2016-07-14 Boston Scientific Scimed, Inc. Élément souple pour la résistance à un flux rétrograde
CA2974532C (fr) 2015-01-23 2023-08-29 Contego Medical Llc Dispositif d'intervention ayant un filtre embolique integre et procedes associes
AU2015411406B2 (en) * 2015-10-09 2019-02-14 Transverse Medical, Inc. Catheter-based apparatuses and methods
CN110974349B (zh) * 2019-11-25 2022-08-02 湖南瑞康通科技发展有限公司 取栓装置及取栓组件
CN112245750B (zh) * 2020-09-24 2023-08-15 中国人民解放军陆军军医大学第二附属医院 多功能气管插管
CN115844491B (zh) * 2022-12-06 2023-05-16 杭州亿科医疗科技有限公司 一种取栓网收缩扩张可控的取栓装置

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7094249B1 (en) * 1997-03-06 2006-08-22 Boston Scientific Scimed, Inc. Distal protection device and method
US5814064A (en) * 1997-03-06 1998-09-29 Scimed Life Systems, Inc. Distal protection device
US6562058B2 (en) * 2001-03-02 2003-05-13 Jacques Seguin Intravascular filter system
US6635070B2 (en) * 2001-05-21 2003-10-21 Bacchus Vascular, Inc. Apparatus and methods for capturing particulate material within blood vessels
US20030060843A1 (en) * 2001-09-27 2003-03-27 Don Boucher Vascular filter system with encapsulated filter
US6890340B2 (en) * 2001-11-29 2005-05-10 Medtronic Vascular, Inc. Apparatus for temporary intraluminal protection
US7001406B2 (en) * 2002-05-23 2006-02-21 Scimed Life Systems Inc. Cartridge embolic protection filter and methods of use
US20060100658A1 (en) * 2004-11-09 2006-05-11 Hiroyuki Obana Interventional guiding sheath system and method of use
US9510930B2 (en) * 2008-10-22 2016-12-06 Contego Medical, Llc Angioplasty device with embolic filter
US9707071B2 (en) * 2004-11-24 2017-07-18 Contego Medical Llc Percutaneous transluminal angioplasty device with integral embolic filter
US7935075B2 (en) * 2005-04-26 2011-05-03 Cardiac Pacemakers, Inc. Self-deploying vascular occlusion device
JP2009517124A (ja) * 2005-11-26 2009-04-30 コンテゴ メディカル エルエルシー 一体型塞栓フィルタを有する経皮経管的血管形成装置
WO2009151761A1 (fr) * 2008-04-10 2009-12-17 Contego Medical Llc Dispositif d'angioplastie muni d'un filtre embolique et d'un boîtier de filtre fixé

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2014150013A1 *

Also Published As

Publication number Publication date
WO2014150013A1 (fr) 2014-09-25
BR112015023627A8 (pt) 2019-12-03
CN105188605B (zh) 2018-02-02
CN105188605A (zh) 2015-12-23
HK1214495A1 (zh) 2016-07-29
EP2967808A4 (fr) 2017-01-25
BR112015023627A2 (pt) 2017-07-18
AU2014237626A1 (en) 2015-10-01
AU2014237626A2 (en) 2017-06-15
JP2016511086A (ja) 2016-04-14

Similar Documents

Publication Publication Date Title
US11865022B2 (en) Transluminal angioplasty devices and methods of use
US20160287844A1 (en) Percutaneous transluminal angioplasty device with integral embolic filter
US8758424B2 (en) Percutaneous transluminal angioplasty device with integral embolic filter
WO2014150013A1 (fr) Dispositif d'angioplastie transluminale percutanée avec filtre embolique intégré
EP2925257B1 (fr) Dispositif d'angioplastie transluminale percutanée avec filtre embolique intégré
US10702367B2 (en) Percutaneous transluminal angioplasty device with integral embolic filter
US20140214067A1 (en) Percutaneous transluminal angioplasty device with integral embolic filter
US6547759B1 (en) Emboli capturing device
US11844679B2 (en) Interventional device having an integrated embolic filter and associated methods
US9895216B2 (en) Percutaneous emboli protection sleeve
US20100106182A1 (en) Angioplasty device with embolic filter
US20160089228A1 (en) Temporary embolic protection device and methods thereof
JP2009517124A (ja) 一体型塞栓フィルタを有する経皮経管的血管形成装置
US20070073332A1 (en) Intraluminal filter having a cover sleeve
JP2013154183A (ja) 一体型塞栓フィルタを有する経皮経管的血管形成装置
WO2009151761A1 (fr) Dispositif d'angioplastie muni d'un filtre embolique et d'un boîtier de filtre fixé
EP4212127A1 (fr) Système de protection du système vasculaire cérébral
WO2002083225A1 (fr) Dispositif de capture d'embole

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20150924

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

AX Request for extension of the european patent

Extension state: BA ME

DAX Request for extension of the european patent (deleted)
REG Reference to a national code

Ref country code: HK

Ref legal event code: DE

Ref document number: 1214495

Country of ref document: HK

A4 Supplementary search report drawn up and despatched

Effective date: 20170102

RIC1 Information provided on ipc code assigned before grant

Ipc: A61M 25/10 20130101ALI20161221BHEP

Ipc: A61M 25/09 20060101ALI20161221BHEP

Ipc: A61F 2/01 20060101AFI20161221BHEP

Ipc: A61M 25/01 20060101ALI20161221BHEP

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: EXAMINATION IS IN PROGRESS

17Q First examination report despatched

Effective date: 20170131

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: EXAMINATION IS IN PROGRESS

RAP1 Party data changed (applicant data changed or rights of an application transferred)

Owner name: CONTEGO MEDICAL, INC.

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 20210608

REG Reference to a national code

Ref country code: HK

Ref legal event code: WD

Ref document number: 1214495

Country of ref document: HK