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WO2024129915A1 - Systèmes, dispositifs et méthodes permettant de fournir une protection embolique distale - Google Patents

Systèmes, dispositifs et méthodes permettant de fournir une protection embolique distale Download PDF

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Publication number
WO2024129915A1
WO2024129915A1 PCT/US2023/083921 US2023083921W WO2024129915A1 WO 2024129915 A1 WO2024129915 A1 WO 2024129915A1 US 2023083921 W US2023083921 W US 2023083921W WO 2024129915 A1 WO2024129915 A1 WO 2024129915A1
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WO
WIPO (PCT)
Prior art keywords
fluid
tube
distal
outlet apertures
embolic protection
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
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PCT/US2023/083921
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English (en)
Inventor
Anand Prasad
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.)
University of Texas System
University of Texas at Austin
Original Assignee
University of Texas System
University of Texas at Austin
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Publication of WO2024129915A1 publication Critical patent/WO2024129915A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3203—Fluid jet cutting instruments
    • A61B17/32037—Fluid jet cutting instruments for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B2017/320716—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions comprising means for preventing embolism by dislodged material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/007—Auxiliary appliance with irrigation system
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0183—Rapid exchange or monorail catheters

Definitions

  • DE Distal embolization
  • TIA transient ischemic attack
  • renal arterial embolization renal arterial embolization
  • arterial bed embolization tissue ischemia/pain
  • Fig. 1A is a diagram that illustrates a first example of providing distal embolic protection within the aortic arch using a distal embolic protection device.
  • Fig. 1 B is a diagram that illustrates a second example of providing distal embolic protection within the aortic arch using a distal embolic protection device.
  • Fig. 1 C is a diagram that illustrates a third example of providing distal embolic protection within the aortic arch using a distal embolic protection device.
  • Fig. 2A is a diagram that illustrates a first example of providing distal embolic protection within the abdominal aorta using a distal embolic protection device.
  • Fig. 2B is a diagram that illustrates a second example of providing distal embolic protection within the abdominal aorta using a distal embolic protection device.
  • Fig. 3 is a block diagram illustrating an embodiment of a system for providing distal embolic protection.
  • Fig. 4A is a side view of a first embodiment of a distal embolic protection device having a guidewire channel.
  • Fig. 4B is an end view of the distal embolic protection device of Fig. 4A.
  • Fig. 5 is a side view of a second embodiment of a distal embolic protection device having a guidewire channel.
  • Fig. 6 is a side view of an embodiment of a distal embolic protection device having a tapered configuration.
  • Fig. 7 is a side view of a first embodiment of a distal embolic protection device having radiopaque markers.
  • Fig. 8 is a side view of a second embodiment of a distal embolic protection device having radiopaque markers.
  • Fig. 9A is a diagram that illustrates an example of providing distal embolic protection within the aortic arch using a right radial artery approach and the right subclavian artery.
  • Fig. 9B is a diagram that illustrates an example of providing distal embolic protection within the aortic arch using a femoral artery approach and the descending aorta.
  • Fig. 10 is a side view of an embodiment of a distal embolic protection device having angled outlet apertures.
  • Fig. 11 is a side view of an embodiment of a distal embolic protection device having integrated outlet nozzles.
  • Fig. 12 is a side view of a first embodiment of a distal embolic protection device configured to receive and pass a separate surgical device.
  • Fig. 13 is an end view of a second embodiment of a distal embolic protection device configured to receive and pass a separate surgical device
  • Fig. 14 is a side view of an embodiment of a controllable distal embolic protection device that can be articulated and rotated to steer it through vessels.
  • a system and method for providing distal embolic protection implements a distal embolic protection device, configured as an elongated tubular device, such as a catheter or sheath, that can extend through an elongated vessel, such as an artery, which is configured to eject a fluid, such as saline, within the vessel for the purpose of driving embolic particles away from organs in need of protection.
  • a distal embolic protection device configured as an elongated tubular device, such as a catheter or sheath, that can extend through an elongated vessel, such as an artery, which is configured to eject a fluid, such as saline, within the vessel for the purpose of driving embolic particles away from organs in need of protection.
  • the device comprises one or more outlet apertures from which the fluid can be ejected in either a continuous, pulsatile, or on-demand manner.
  • the device can be used to drive the particles farther along a primary vessel (e.g., aorta) so as to prevent the particles from entering a branch vessel (e.g., carotid artery) that leads to the organ (e.g., brain).
  • a primary vessel e.g., aorta
  • a branch vessel e.g., carotid artery
  • the organ e.g., brain
  • a system and method for providing distal embolic protection implement a distal embolic protection device that can drive embolic particles away from an organ to be protected.
  • the device can be used to divert particles away from the cerebral vessels (e.g., carotid and/or vertebral arteries) to prevent stroke or transient ischemic attack (TIA).
  • TIA stroke or transient ischemic attack
  • Such particles typically range in size (e.g., nominal diameter) from 150 to 1 ,000 microns.
  • the device can be used to divert particles away from the renal arteries to prevent acute kidney injury (AKI). Irrespective of where it is used, the device creates a flow analogous to a fast moving river that carries debris (embolic particles) away from side branches (branch vessels) and downstream along the “river” (primary vessel).
  • AKI acute kidney injury
  • the system and method can implement one or more other devices, such as a pump, which can be used to drive the fluid through the device and out one or more of its outlet apertures such that the fluid is injected into the vessel.
  • the outlet apertures can comprise outlet nozzles that generate jets of fluid that are particularly well-suited for diverting the embolic particles from the branch vessels.
  • device can also be used to collect particles so that they can be removed from the body.
  • the device can include one or more inlet apertures through which fluid and particles can be drawn into the device using a suction device.
  • the device can comprise a first internal lumen configured to supply fluid to the outlet aperture(s) and a second internal lumen configured to receive fl uid/particles from the inlet aperture(s).
  • Figs. 1A-1 C illustrate examples of providing distal embolic protection within the aortic arch using distal embolic protection devices.
  • aortic arch 10 which includes the ascending aorta 12, the innominate artery 14, the left common carotid artery 16, the left subclavian artery 18, and the descending aorta 20.
  • a first distal embolic protection device 22 configured as an elongated tubular device having a continuous outer wall that forms a tube defining a continuous, elongated inner lumen, such as a catheter.
  • the device 22 is positioned within the innominate artery 14 via radial artery access and a second distal embolic protection device 24 also configured as an elongated catheter is positioned within the left subclavian artery 18 also via radial artery access.
  • Each tube is made of a biocompatible, flexible polymeric material that includes a plurality of outlet apertures 26 that extend through the wall of a distal portion of the tube.
  • the apertures 26 can be located on multiple sides of the device 22.
  • Driving fluid e.g., liquid
  • the apertures 26 can, in some embodiments, be configured as nozzles that create jets of fluid.
  • the devices 22, 24 can either be provided with an opening at its distal tip or can have a closed tip.
  • the fluid ejected from the apertures of the first distal embolic protection device 22 creates a flow, represented by multiple arrows, that drives embolic particles, represented by small circles.
  • embolic particles represented by small circles.
  • the particles have reached the innominate artery 14 but the flow created by the ejected liquid drives the particles out from the artery and down to the ascending aorta 12 so that the particles cannot reach the brain via a branch artery, such as the right carotid artery 28.
  • the flow of fluid ejected from the device 22 can be continuous or pulsatile, depending upon how the fluid is supplied to the device.
  • fluid can be ejected from the device 22 on demand using a suitable controller.
  • the fluid ejected from the apertures 26 of the second distal embolic protection device 24 also creates a flow that drives embolic particles.
  • the particles are driven from the left subclavian artery 18 into the descending aorta 20, which also prevents the particles from reaching the brain via a branch artery, such as the left common carotid artery 16.
  • the devices 22, 24 are used to drive embolic particles to and/or maintain embolic particles within the aortic arch 10 so that they do not reach an organ to be protected, such as the brain.
  • both devices 22, 24 can be used together to create a desired flow.
  • the devices 22, 24 can be used independent of each other.
  • a distal embolic protection device 30 is configured as an elongated tubular device, such as a catheter. More particularly, the device 30 is configured as a pigtail catheter having a distal end that forms a curled pigtail 32. As shown in the figure, the device 30 is provided within the aortic arch 10, extending from the descending aorta 20 into the ascending aorta 12. Like the previous device 22, the device 30 can be made of a suitable flexible polymeric material and comprise a plurality of outlet apertures 34 formed in the wall of the device from which a driving fluid (e.g., saline) can be ejected.
  • a driving fluid e.g., saline
  • each of the apertures 34 is positioned on an inner side of a curvature of the device 30 so as to direct embolic particles away from the branch arteries that extend upward from the aorta (in the orientation of the figure), which are located beyond the outer side of the curvature of the device.
  • the device 30 includes auxiliary outlet apertures 36 formed through the wall of the device adjacent to the pigtail 32 that can be used to eject contrast fluid into the vessel.
  • the device 30 can comprise two distinct inner lumens, one that supplies the driving fluid to the apertures 34, and one that supplies contrast fluid to the apertures 36.
  • Fig. 1 C illustrates a further example of providing distal embolic protection within the aortic arch 10.
  • a distal embolic protection device 40 is configured as configured as a pigtail catheter having a distal end that forms a curled pigtail 42 and is provided within the aorta extending from the descending aorta 20 into the ascending aorta 12.
  • the device 40 comprises a plurality of outlet apertures 44 formed through the wall of the device near and along the pigtail 42 from which a driving fluid can be ejected.
  • the apertures 44 are provided on both the inner and outer sides of the curvature of the device, and the ejected fluid can be saline, contrast fluid, or both.
  • inlet apertures 46 are formed through the wall of the device 40 proximal of the outlet apertures. When the device 40 is positioned as shown in Fig. 1 C, the inlet apertures 46 are located downstream of the outlet apertures 44 in terms of blood flow through the aortic arch and, therefore, can be used to draw in embolic particles and/or contrast fluid displaced by or ejected from the outlet apertures so that the particles and/or contrast fluid can be removed from the vessel.
  • the device 40 can also comprise two distinct inner lumens, one that supplies fluid to the outlet apertures 44, and one that receives fluid drawn in through the inlet apertures 46.
  • Figs. 2A and 2B illustrate distal embolic protection being provided within the abdominal aorta 50 using two different distal embolic protection devices. As shown in Fig. 2A, the right and left kidneys 52 and 54 are in fluid communication with the abdominal aorta 50 via the right and left renal arteries 56 and 58, respectively. Also shown in the figure are embolic particles, again represented by small circles, that have traveled down the abdominal aorta 50 and adjacent to the renal arteries 56, 58.
  • a distal embolic protection device 60 configured as an elongated tubular device, such as a catheter, is provided within the abdominal aorta 50 that ejects fluid from a distal outlet aperture 62 provided at the distal tip of the device.
  • the flow created by the ejected fluid drives the embolic particles past the renal arteries 56, 58 so that the particles do not have an opportunity to enter the renal arteries 56, 58 and travel into the kidneys 52, 54.
  • the flow may further draw particles out from the renal arteries 56, 58 to protect the kidneys 52, 54.
  • a further distal embolic protection device 70 is shown provided in the abdominal aorta 50.
  • the device 70 is also configured as an elongated tubular device, such as a catheter, and comprises a plurality of outlet apertures 72 from which driving fluid can be ejected.
  • the device 70 includes a plurality of inlet apertures 74 with which the embolic particles can be collected and removed.
  • the device 70 can comprise distinct inner lumens that are associated with apertures 72 and apertures 74, respectively.
  • the one or more distal embolic protection devices can comprise part of a system for providing distal embolic protection that includes other components.
  • Fig. 3 illustrates an example of one such system 80.
  • the system 80 comprises a distal embolic protection device 82.
  • the device 82 is configured as an elongated tubular device, such as a catheter, that includes a continuous outer wall 84 that defines a continuous, elongated inner lumen 85.
  • a driving fluid or contrast fluid e.g., liquid
  • inlet apertures 88 through which fluid can be drawn into the device, such as blood and the ejected fluid, as well as particles suspended in that fluid.
  • Extending through the inner lumen 85 of the device 82 are first and second inner tubes 90 and 92 that define their own first and second inner lumens 91 and 93, respectively.
  • the lumens 91 and 93 are respectively in fluid communication with the outlet apertures 86 and the inlet apertures 88.
  • the system 80 also includes a pump 94, or other fluid driving means, which is in fluid communication with the first inner lumen 91 , and a vacuum source 96 that is in fluid communication with the second inner lumen 93.
  • the pump 94 is in fluid communication with the outlet apertures 86 and the vacuum source 96 is in fluid communication with the inlet apertures 88.
  • the pump 94 can be in fluid communication with a first reservoir (not shown) that contains fluid to be ejected from the device 82, and the vacuum source 96 can be in fluid communication with a second reservoir (not shown) that is configured to receive and contain the fluid drawn into the device.
  • control system 98 that is configured to control operation of at least the pump 94 and the vacuum source 96.
  • the control system 98 can operate the pump 94 to drive fluid through the first inner lumen 90 and out from the outlet apertures 86, and to operate the vacuum source 96 to drawn in fluid through the inlet apertures 92 and along the second inner lumen 92.
  • the control system 98 comprises a computer including a processor and memory, the memory storing one or more software programs and/or algorithms comprising computer-readable instructions that are configured to control at least the operation of the pump 94 and the vacuum source 96.
  • the control system 98 can further include one or more sensors (not shown) that collect data that can be used by the control system as feedback to determine when and how to operate the pump 94 and the vacuum source 96.
  • Figs. 4A and 4B illustrate an embodiment of a distal embolic protection device 100 that is configured for insertion into and passage through passages, such as mammalian (e.g., human) blood vessels.
  • the device 100 is configured as an elongated tubular device, such as a catheter.
  • the device 100 comprises an elongated tube 102 that is formed by a continuous outer wall 104 that defines a continuous, elongated inner lumen 106.
  • the tube 102 is cylindrical and has a circular cross-section, as does its inner lumen 106.
  • the tube 102 has an elliptical cross-section or a cross-section that defines an alternative geometric shape.
  • the tube 102 includes an integrated guidewire channel 106 through which a guidewire can be passed through and out from the tube to guide the device 100 along one or more blood vessels, such as the coronary arteries.
  • the tube 102 is made of a biocompatible, flexible polymeric material and has a French size of 6, 7, or 8 Fr. Any of those sizes are suitable for femoral artery access delivery, while the 6 and 7 Fr-sized devices are most suitable for radial artery access delivery.
  • the guidewire channel 106 comprises a lumen that extends through the outer wall 104 of the elongated tube 102 and, as shown most clearly in Fig. 4A, terminates in an exit opening 110 from which a guidewire that has passed through the channel can emerge from the distal end 112 of the device 100.
  • the guidewire channel 106 can be specifically configured to receive and permit to pass a guidewire having a diameter of approximately 0.014 inches.
  • a blunt, atraumatic tip 114 can be provided at the distal end 112 of the device 100 (and the distal end of the elongated tube 102) to facilitate passage of the device through patient blood vessels.
  • such an atraumatic tip 114 can have the shape of a rounded cone. More particularly, the atraumatic tip 114 can be shaped like a cone having rounded tip instead of a pointed tip, like a conventional bullet (i.e., bullet shaped).
  • the atraumatic tip 112 comprises a separate component that is fixedly attached to the distal end of the tube 102. In other embodiments, the atraumatic tip 112 is unitarily formed with the tube 102.
  • the atraumatic tip 112 closes and seals the inner (primary) lumen 106 such that fluid, described below, cannot flow out from the distal end of the device 100.
  • the guidewire channel 106 can, in some embodiments, extend through the atraumatic tip 114.
  • the tube 102 comprises one or more groups of approximately 3 to 20 outlet apertures 116 that are arranged and aligned in a linear row that extends along a longitudinal or length direction of the tube 102.
  • the outlet apertures 116 are equally spaced from each other within the row (i.e., equidistant spacing) and the group is wholly contained within a portion or section of the tube’s length that is located near the distal end 112 of the device 100 (i.e., a distal portion or section of the tube).
  • the row and each of the apertures 116 it comprises extends along a particular side of the tube 102 although, as described above, one or more further groups (e.g., rows) of apertures can be provided on multiple (e.g., opposing) sides of the tube.
  • the apertures 116 are configured to eject a fluid, such as saline, that is delivered under pressure to the inner lumen 106 of the tube 102 so as to create a fluid flow within a patient’s blood vessel that drives or carries debris, such as embolic particles, in a direction away from an organ that is to be protected, such as the brain.
  • Fig. 5 illustrates another embodiment of a distal embolic protection device 120 configured to receive a guidewire.
  • the device 120 has the same basic construction as the device 100 described above in relation to Figs. 4A and 4B. Accordingly, the device 120 comprises an elongated tube 122 that is formed by a continuous outer wall 124 that defines a continuous, elongated inner lumen 126.
  • the tube 122 also includes an integrated guidewire channel 128 through which a guidewire can be passed through and out from an exit opening 130 located at the distal end 132 of the device 120.
  • a blunt, atraumatic tip 134 is also provided at the distal end 132 of the device 120 .
  • the tube 122 includes multiple aligned outlet apertures 136 that extend through the outer wall 124 of the tube 122 to the inner lumen 126.
  • the guidewire channel 128 extends through a side of the tube 122 at a predetermined location spaced from the distal end 132 of the device 120 to form a side port 138 through which a guidewire can be inserted into the channel in similar manner to “rapid exchange” catheters.
  • Fig. 6 illustrates a further example distal embolic protection device 140.
  • the device 140 is similar to those shown in Figs. 4 and 5 as the device 140 comprises an elongated tube 142 that is formed by a continuous outer wall 144 that defines a continuous, elongated inner lumen 146.
  • a distal end 148 of the device 140 is a blunt, atraumatic tip 150.
  • the tube 142 does not include an independent guidewire channel. Instead, a guidewire can be fed through the inner lumen 146 and out through an exit opening 152 that is formed in through the atraumatic tip 150.
  • the tube 142 has a tapered region along which the tube narrows toward the distal end 148 of the device 140.
  • the tapered region occupies only a portion of the length of the tube 142.
  • the tube 142 can be tapered along a portion of its length adjacent the distal end 148 of the device 148.
  • the taper can continue all the way to the distal end of the tube 142, or stop at a point proximal of that end, in which case the tube can have a constant width (e.g., diameter) from the end of the tapered region to the distal end of the tube.
  • the taper can be a constant linear taper, in which case the tube 142 tapers at a constant linear rate, or the taper can be non-constant, in which case the rate of tapering can be non-linear and/or the tapered region can comprise multiple sections having different linear or nonlinear rates of tapering.
  • the width (e.g. , diameter) of the tube 142 is smallest at its distal end at which the atraumatic tip 150 is located.
  • the inner lumen 146 also has a tapered region in which its width (e.g., diameter) decreases in the direction of the distal end 148 of the device 140. That tapering facilitates alignment of the guidewire with the exit opening 152 formed through the atraumatic tip 150 and, therefore, facilitates passage of the guidewire out from the distal end 148 of the device 140.
  • the elongated tube 142 includes multiple aligned outlet apertures 154 that extend through the outer wall 144 of the tube to the inner lumen 146 through which fluid (e.g., saline) can exit the device 140 and create a flow within a blood vessel in which the device has been placed.
  • fluid e.g., saline
  • the exit opening 152 formed through the atraumatic tip 150 is in fluid communication with the inner lumen 146
  • the size (e.g., diameter) of the opening is much smaller than the size (e.g., diameter) of the outlet apertures 134 such that not much of the fluid exits the device 140 through the exit opening.
  • the tapered configuration of the inner lumen 146 prevents pressure loss that could otherwise occur due to the presence of an exit opening 152 formed at the distal end 148 of the device 140.
  • radiopaque markers can be provided on the distal embolic protection device to help an operator of the device (e.g., surgeon) or an assistant (e.g., nurse) determine its orientation when it is fluoroscopically imaged. Examples of this are shown in Figs. 7 and 8.
  • a distal embolic protection device 160 comprises an elongated tube 162 that is formed by a continuous outer wall 164 that defines a continuous, elongated inner lumen 166.
  • a blunt, atraumatic tip 170 Provided at a distal end 168 of the device 160 is a blunt, atraumatic tip 170.
  • the tube 162 further includes multiple aligned outlet apertures 172 that extend through the outer wall 164 of the tube to the inner lumen 166 from which fluid (e.g., saline) can exit the device 160.
  • the tube 162 further comprises multiple radiopaque markers 174 that can be seen under fluoroscopy.
  • one marker can be provided for each outlet aperture 172, but on the opposite side of the tube with one marker directly opposed to each aperture, as illustrated in Fig. 7. In such cases, the operator and/or assistant can infer the locations of the outlet apertures 172 under fluoroscopy.
  • Fig. 8 illustrates another example of a distal embolic protection device that includes radiopaque markers.
  • a distal embolic protection device 180 comprises an elongated tube 182 that is formed by a continuous outer wall 184 that defines a continuous, elongated inner lumen 186.
  • a blunt, atraumatic tip 190 Provided at a distal end 188 of the device 180 is a blunt, atraumatic tip 190.
  • the tube 182 further includes multiple aligned outlet apertures 192 that extend through the outer wall 184 of the tube to the inner lumen 186.
  • the tube 182 further comprises multiple radiopaque markers 194 that, as shown in Fig. 8, are positioned on the same side of the outlet apertures 192 with one marker being provided directly adjacent each outlet aperture. In such a case, a radiopaque marker 194 can at least be located between each pair of outlet apertures 192 along the line of apertures.
  • the elongated tubes of the distal embolic protection devices described above are flexible to enable navigation of the devices through the patient blood vessels. It is noted, however, that it is desirable in some embodiments that the tube is sufficiently stiff so as to remain in a stable position within the vessel, for example, in the innominate artery.
  • Positioning of a distal embolic protection device 196 within the aortic arch via a radial artery approach is shown in Fig. 9A, while Fig. 9B shows a distal embolic protection device 198 positioned within the aortic arch via a femoral artery approach.
  • a distal embolic protection device comprising a 6 Fr or 7 Fr tube might be appropriate for both radial and femoral artery approaches, while a device comprising an 8 Fr tube might only be appropriate for femoral artery approaches.
  • the larger the tube the greater the volume of fluid that can be ejected into the vessel and the greater the amount of debris that can be driven or carried away. While an 8 Fr tube would provide the greatest flow and may provide the greatest protection, it may be less clinically attractive.
  • the outlet apertures have not been described with particularity.
  • the outlet apertures can comprise simple openings formed through the tube wall from which fluid can be ejected.
  • such openings can be round or elliptical.
  • the outlet apertures can be configured to provide a specific functionality or performance. Figs. 10 and 11 illustrate examples of such apertures.
  • a distal embolic protection device 200 comprising an elongated tube 202 that is formed by a continuous outer wall 204 that defines a continuous, elongated inner lumen 206.
  • a blunt, atraumatic tip 210 Provided at a distal end 208 of the device 200 is a blunt, atraumatic tip 210.
  • the tube 202 further includes multiple outlet apertures 212 that extend through the outer wall 204 of the tube and are aligned in a row on one side of the tube. In the embodiment of Fig. 10, however, the outlet apertures 212 are angled relative to the outer wall 204 such that their central axes along with they eject fluid is non-perpendicular to the portion of the wall surrounding the aperture.
  • the outlet apertures 212 are configured to eject fluid in a direction that forms an angle other than 90° with a central longitudinal axis of the tube 202 when the tube is in a straight (non-curved) orientation.
  • the outlet apertures 212 are configured to eject fluid at an acute angle 0 that ranges from approximately 10 to 80 degrees. Such angulation may assist the operator in directing flow and, therefore, embolic particles, in a particular desired direction, such as toward and/or down the descending aorta.
  • Fig. 11 shows a further embodiment of a distal embolic protection device that comprises outlet apertures configured to provide a specific functionality or performance.
  • a distal embolic protection device 220 comprises an elongated tube 222 that is formed by a continuous outer wall 224 that defines a continuous, elongated inner lumen 226.
  • a blunt, atraumatic tip 230 Provided at a distal end 228 of the device 220 is a blunt, atraumatic tip 230.
  • the tube 222 further includes multiple outlet apertures 232 that extend through the outer wall 224 of the tube and are aligned in a row on one side of the tube.
  • the outlet apertures 232 are angled relative to the outer wall 224 and are, therefore, configured to eject fluid at an acute angle, for example, in the range of approximately 10 to 80 degrees.
  • the outlet apertures 232 each comprise a nozzle 234 that is configured to eject jets of fluid having greater velocity than the fluid that can be ejected from similarly sized openings formed through a tube wall. The result is the generation of a stronger flow that may be more effective at controlling the direction of travel of embolic particles.
  • the nozzles 234 are separate components that are fixedly attached to the tube 222. In other embodiments, the nozzles 234 are unitarily formed with the tube 222.
  • each device has been configured as a catheter that is configured to receive only fluid and possibly a guidewire.
  • a distal embolic protection device can be configured as a sheath that is capable of receiving and guiding a separate surgical device, such as a catheter.
  • Fig. 12 illustrates an example of such a device.
  • a distal embolic protection device 240 comprises an elongated tube 242 that is formed by a continuous outer wall 244 that defines a continuous, elongated inner lumen 246.
  • a distal opening 250 Provided at a distal end 248 of the device 240 is a distal opening 250, and provided in a row on one side of the tube 242 are multiple outlet apertures 252 that extend through the outer wall 244 to the inner lumen 246.
  • fluid can be ejected from the inner lumen via the outlet apertures 252 in the manner described above.
  • a separate surgical device 254 can be passed through the inner lumen 246 and out from the distal opening 250.
  • the device 254 can comprise a catheter, such as a pigtailed catheter, that can be used to deliver contrast liquid to the patient blood vessel.
  • a catheter such as a pigtailed catheter
  • the device 240 can be used in similar manner to a sheath through which such catheters are often passed, but further provides embolic protection by controlling flow within the vessel.
  • embolic protection by controlling flow within the vessel.
  • Such a device embodiment may be desirable in some cases given the limited space available in such vessels.
  • a distal embolic protection device 260 comprises an elongated tube 262 that is formed by a continuous outer wall 264 that defines a continuous, elongated inner lumen 266.
  • the lumen 266 is divided into a first or working lumen 268 and a second or fluid lumen 270 by a dividing wall 272.
  • a separate device can be passed through the working lumen 268 and fluid can be separately passed through the fluid lumen 270 to supply outlet apertures 274 that extend through the outer wall 264 and into the fluid lumen.
  • a distal embolic protection device can include a blunt, atraumatic tip having an exit opening that is large enough to permit the separate device to exit the device, while still providing a rounded profile that facilitates navigation of patient vessels.
  • a distal embolic protection device of the nature of any of the devices described above can be manipulated by the operator to steer it through patient vessels.
  • Fig. 14 illustrates an example of this.
  • a distal embolic protection device 280 having a design similar to those described above.
  • at least a distal portion of the device 280 can be articulated by the operator using a suitable articulation mechanism (not shown) to bend the device and change the direction in which its tip is directed.
  • the tip can be displaced in either of two directions within a single plane.
  • the tip can be displaced in either of two directions within two or more planes, such as a first plane and a second plane that is perpendicular to the first plane.
  • the device 280 can include a rotation mechanism (not shown) that enables the operator to rotate at least a distal portion of the device about its central longitudinal axis, as indicated by arrow 284. Such articulation and rotation facilitates entry into and passage through serpentine vessels to enable the device 280 to be positioned in the best location to provide the desired protection.
  • a locking mechanism (not shown) can be provided that locks the device in a particular orientation, such as a particular articulation and/or rotational position.

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Abstract

Dans un mode de réalisation, un dispositif de protection embolique distale comprend un tube allongé conçu pour le passage à travers une artère, le tube étant formé par une paroi externe qui définit une lumière interne allongée et qui comprend de multiples ouvertures de sortie à partir desquelles le fluide délivré à la lumière interne peut être éjecté dans l'artère pour entraîner des particules emboliques à l'intérieur de l'artère dans un sens souhaité.
PCT/US2023/083921 2022-12-13 2023-12-13 Systèmes, dispositifs et méthodes permettant de fournir une protection embolique distale Ceased WO2024129915A1 (fr)

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5536242A (en) * 1994-07-01 1996-07-16 Scimed Life Systems, Inc. Intravascular device utilizing fluid to extract occlusive material
EP0489496B1 (fr) * 1990-11-08 1996-08-14 Possis Medical, Inc. Dispositif d'athérectomie par jet d'eau
US20150173782A1 (en) * 2013-12-23 2015-06-25 Silk Road Medical, Inc. Methods and Systems for Treatment of Acute Ischemic Stroke
US10307242B2 (en) * 2016-09-07 2019-06-04 Daniel Ezra Walzman Simultaneous rotating separator, irrigator microcatheter for thrombectomy and method of use
US20190217049A1 (en) * 2018-01-16 2019-07-18 Daniel Ezra Walzman Bypass Catheter
US10398875B2 (en) * 2015-01-09 2019-09-03 Accurate Medical Therapeutics Ltd. Embolization microcatheter
US20210196292A1 (en) * 2019-12-26 2021-07-01 Neuravi Limited Intravascular Catheter

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0489496B1 (fr) * 1990-11-08 1996-08-14 Possis Medical, Inc. Dispositif d'athérectomie par jet d'eau
US5536242A (en) * 1994-07-01 1996-07-16 Scimed Life Systems, Inc. Intravascular device utilizing fluid to extract occlusive material
US20150173782A1 (en) * 2013-12-23 2015-06-25 Silk Road Medical, Inc. Methods and Systems for Treatment of Acute Ischemic Stroke
US10398875B2 (en) * 2015-01-09 2019-09-03 Accurate Medical Therapeutics Ltd. Embolization microcatheter
US10307242B2 (en) * 2016-09-07 2019-06-04 Daniel Ezra Walzman Simultaneous rotating separator, irrigator microcatheter for thrombectomy and method of use
US20190217049A1 (en) * 2018-01-16 2019-07-18 Daniel Ezra Walzman Bypass Catheter
US20210196292A1 (en) * 2019-12-26 2021-07-01 Neuravi Limited Intravascular Catheter

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