WO2025008042A1 - Cathéter d'athérectomie et système d'athérectomie - Google Patents

Cathéter d'athérectomie et système d'athérectomie Download PDF

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Publication number
WO2025008042A1
WO2025008042A1 PCT/EP2023/068207 EP2023068207W WO2025008042A1 WO 2025008042 A1 WO2025008042 A1 WO 2025008042A1 EP 2023068207 W EP2023068207 W EP 2023068207W WO 2025008042 A1 WO2025008042 A1 WO 2025008042A1
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WO
WIPO (PCT)
Prior art keywords
rotor
distal
stator
profile configuration
catheter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2023/068207
Other languages
English (en)
Inventor
Fabian Haller
Steffan DANIEL
Bruno BAHNMUELLER
Bedjet Aziri
Johannes HASLER
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.)
Straub Medical AG
Original Assignee
Straub Medical AG
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 Straub Medical AG filed Critical Straub Medical AG
Priority to PCT/EP2023/068207 priority Critical patent/WO2025008042A1/fr
Publication of WO2025008042A1 publication Critical patent/WO2025008042A1/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
    • 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
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • 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
    • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00681—Aspects not otherwise provided for
    • A61B2017/00685—Archimedes screw
    • 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
    • A61B2017/320004—Surgical cutting instruments abrasive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
    • A61B2090/034—Abutting means, stops, e.g. abutting on tissue or skin abutting on parts of the device itself
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system

Definitions

  • the lumen of a vessel i.e. the cross-section of the vessel (also referred to as the so-called luminal gain) . It may be necessary during a procedure to change the catheter to a bigger size, i.e. use a larger head/tip of a catheter for a subsequent pass, so as to increase the luminal gain. For example, a smaller access puncture may be preferable in terms of closure after the procedure or because of restrictions on access dimensions, e.g. due to scarring. For various reasons, it may be desired or necessary to use a relatively small catheter size for access and/or different catheter sized during the same procedure, with different head/tip sizes.
  • the present disclosure provides an atherectomy catheter having a functional section that can selectively assume a low-profile configuration and a protruding/extended/enlarged, i.e. large-profile configuration.
  • the low-profile configuration has a lower profile than the large-profile configuration. Accordingly, the large-profile configuration has a larger profile than the low-profile configuration.
  • An atherectomy catheter of the disclosure comprises a tube having a proximal and a distal tube end, and a distal head protruding from the distal tube end in the distal direction, wherein the distal head comprises a stator which is stationary relative to the tube and connected to the distal tube end, and a rotor which is rotatable relative to the stator and to the tube and has a proximal end and a distal tip .
  • the rotor is at least partially located outside the stator or the stator is at least partially received inside the rotor (but this may not be necessary) .
  • the stator and the rotor are configured such that the rotor is rotatable at least at a speed of 5000 rpm relative to the stator .
  • the rotor comprises a bearing, a distal tip and a functional section .
  • the bearing is provided, optionally at the proximal end of the rotor, for rotatable support relative to the stator .
  • the distal tip may optionally comprise at least partially an abrasive surface for removing clot and/or calci fications from a vessel wall .
  • the functional section is configured such that the rotor can assume a low-profile configuration in which the functional section has a first diameter and a first length, and a large-profile configuration in which the functional section has a second length and at least in one part a second diameter, wherein the first diameter is smaller than the second diameter, and the first length is greater than the second length .
  • the catheter may be configured such that the transition from the low-profile configuration to the large-profile configuration is initiated by a reduction of the length from the first length to the second length and such that said transition represents , at the same time , and enlargement from the first diameter to the second diameter .
  • Alternative or additional wording for the last section of claim 1 may be as follows :
  • the catheter is configured such that the functional structure is urged/ forced to shorten the length of the functional section and to bend/bulge outwardly into the large-profile configuration by retraction of an actuator ( drive shaft ) in the low-profile configuration .
  • the distal tip is movable relative to the drive shaft along the distal/proximal , i . e . axial , direction . While the bearing remains at a constant axial position (when comparing the low-profile and large-profile configurations , relative to the tube ) , the distal tip is distal to the bearing and is movable in the longitudinal direction .
  • the bearing supports rotation of the rotor relative to the stator at high rotational speeds .
  • the functional section is configured accordingly .
  • the functional section of an atherectomy catheter of the disclosure is configured to selectively assume the low-profile configuration and the large-profile configuration .
  • the functional structure may be regarded as an expandable structure , as it can be expanded as to its diameter .
  • the invention is based on the idea of the inter-/counter-play between the diameter and the length of the functional section .
  • the larger the second diameter in the large-profile configuration the shorter the second length .
  • the second length and the second diameter are inversely related .
  • the shorter the length of the functional section the larger the radial extension of the functional section .
  • the radial dimension/extension, e . g . the diameter, of the head/ functional section is indirectly coupled to the longitudinal dimension/ length of the functional section .
  • the functional section may be regarded as expandable ( in the radial direction) .
  • the radial expansion may be continuous along the circumference . In other words , the same angular expansion may be obtained .
  • the present disclosure may be characterised by the functional section and the high-speed rotation of the rotor, and optionally the abrasive surface of the distal tip of the rotor .
  • the catheter may be suitable for various vessel diameters , i . e . for versatile use .
  • the catheter can be adj usted by way of the selection of the configuration, so that a change of the catheter may possibly be avoided . Accordingly, an additional luminal gain can be achieved without the need to change the catheter or possibly to increase the passes made .
  • the catheter of the disclosure may allow to adj ust the diameter of the functional section in the large-profile configuration in real time , and speci fically adj ust it to the anatomy in which the rotor of the atherectomy catheter is at one moment in time during a procedure .
  • This provides the advantage that the catheter does not need to be confined to predetermined radial dimensions . Rather, according to need, the second diameter of the large-profile configuration can be adapted as needed .
  • the large-profile configuration may represent a robust and strong structure so as to allow for removal of calci fications , not only of soft tissue clot .
  • an abrasive coating e . g . a diamond coating on the rotor may be beneficial .
  • the low-profile configuration and the large-profile configuration relate to the radial extension of the functional section ( in the transverse direction) , i . e . in the direction orthogonal to the distal/proximal direction .
  • the transition between the low-profile and the large-profile configurations may be continuous . As such, a stepless change/ shi ft from the low-profile configuration to the large- profile configuration may be possible . Vice versa, this applies to a transition from the large-profile configuration to the low-profile configuration .
  • Changing between the low- profile configuration and the large-profile configuration may be regarded as a reversible procedure .
  • the rotor may be regarded as a rotor head .
  • the functional section which is part of the rotor, rotates at a relatively high speed, namely at a speed of at least 5000 rpm relative to the stator and to the remaining catheter .
  • no shearing ef fect may occur between the rotor and the stator, at least in some embodiments .
  • the second diameter is larger than the first diameter, and this may be supported by the stator being at least partially beneath the rotor, for the following reason :
  • the " surplus" part of the functional section may be prone to f olding/bending .
  • the stator may hinder the " surplus" of the functional section to bend inwardly . Therefore , the overlap of the functional section on the stator may support the desired bending/bulging towards the outside , so as to increase the diameter of the functional section in the large-profile configuration .
  • the tube may comprise a braiding, so as to form a braided catheter shaft .
  • the tube material may be ... a combination of a sti f fer outer layer (such as polyamide ) and a friction reducing inner layer (such as PTFE or polyimide ) .
  • a stainless steel or Aramid fibre braiding in between the other and inner layers may be provided . It may support the catheter in sti f fness for better push and torque ability .
  • the stator comprises at least one window for allowing for entry of clot and/or calci fications into the tube .
  • the functional section may have openings to allow clot and/or calci fications to pass through .
  • the stator and the rotor may be configured such that the at least one window of the stator and the openings of the rotor intermittently overlap during rotation of the rotor so as to allow for aspiration of clot and/or calci fications from outside of the rotor to the inside of the stator and the tube .
  • a suction port is created, so that suction of clot/calci f ications through the rotor and stator can take place .
  • the functional section is configured to be engaged with the vessel wall and/or to scratch or abrade clot/calci f ications from the vessel wall .
  • an outer surface of the rotor may, during rotation, be in close contact with the vessel wall .
  • the catheter further comprises a drive shaft , which may be a torque cable , extending along the tube and connected to the distal tip of the rotor for rotatably driving the rotor .
  • the rotor may be driven by the drive shaft .
  • the torque cable may be connected at the proximal end of the catheter shaft to a drive motor . This allows for an ef ficient driving of the rotor .
  • the drive shaft has a lumen to receive a guidewire . This allows for an over-the-wire atherectomy catheter .
  • the drive shaft may serve as an actuator for changing between the low-profile and large-profile configurations and/or wherein the catheter is configured such that retraction of the drive shaft in the proximal direction renders the functional section in the large-profile configuration and pushing of the drive shaft in the distal direction renders the functional section in the low-profile configuration .
  • the low-profile configuration is changed to the large- profile configuration .
  • the actuation includes an axial translation of torque cable . This may be initiated by the user/operator . Accordingly, a mechanically reliable configuration which may be easy to operate is obtained .
  • the actuator In the low-profile configuration, the actuator may be in its distal position .
  • the actuator In the large-profile configuration, the actuator may be in its proximal position .
  • the functional section When the driveshaft/ torque cable is retracted, i . e . pulled by the user, the functional section is reduced as to its length, i . e . shortened, so that the distal tip of the rotor and the bearing are closer to each other and their distance is reduced .
  • the driveshaft/ torque cable may be advanced, i . e . pushed forward, so that the low-profile configuration is resumed .
  • a helix may surround the drive shaft and/or may extend along an outer surface of the drive shaft .
  • clot and/or calci fications may be conveyed proximally .
  • the helix may rotate together with the drive shaft .
  • the helix may be provided on an outer surface of the torque cable/drive shaft . Rotation of the torque cable rotates the helix, which creates suction so as to aspirate atherosclerotic material , i . e . clot and/or calci fications .
  • the helix serves for transport of clot and/or calci fications .
  • aspiration is created by the rotating helix, and represents an Archimedes screw to transport the material towards the proximal end of the catheter .
  • an outer surface of the functional section is at least partially coated with an abrasive coating .
  • an abrasive coating By way of the abrasive coating, removal of clot and/or calci fications may be improved .
  • an abrasive surface may be provided on the distal tip of the rotor .
  • an outer surface of the stator is at least partially coated with a durable coating to reduce friction between the rotor and the stator.
  • the bearing is at least partially coated with such coating on a bearing surface. This may reduce wear.
  • ADLC coating may be provided on stainless steel.
  • the bearing may be located at the proximal end of the rotor and/or may be ringshaped .
  • the functional section may comprise a functional structure, optionally the functional structure comprising cutting edges configured to cut clot and/or calcifications from a vessel wall and/or the functional structure may be a metal structure.
  • the functional structure is inelastic, while allowing for bending, i.e. while being bendable. This means that the length of the functional structure remains constant .
  • the functional structure may comprise metal, optionally memory metal, such as nitinol.
  • An advantage of using memory metal may be that ... the characteristics (super elasticity) of this material may allow for better resistance to (constant) bending forces.
  • a distal end of the functional structure is captured by the distal tip of the rotor (5) and/or a proximal end of the functional structure is captured by the bearing.
  • the functional structure (section) may comprise struts, optionally woven and/or perforated struts. Further optionally, woven nitinol struts are comprised.
  • the struts of the functional structure are not movable relative to each other.
  • the functional section (structure) and its struts may be inelastic, i.e. not resilient.
  • the struts may be provided in a pattern such that openings in the functional structure allow for clot and/or calci fications to pass through .
  • the distal tip may be made of stainless steel and/or may be hood-shaped .
  • Stainless steel may supply suf ficient sti f fness to the tip and may, at the same time , serve as an appropriate basis for the abrasive coating .
  • the hood-shape of the tip may support passing of the catheter through an occlusion or vessel having a reduced diameter .
  • the distal tip may comprise a through-hole for receiving the drive shaft and/or a guidewire .
  • the drive shaft can be connected to the distal tip of the rotor, so as to rotatably drive the rotor .
  • a guidewire may extend through the through-hole , optionally through an inner lumen of the torque cable/drive shaft .
  • the distal tip and the bearing are connected by means of the functional section .
  • the functional section is positioned between the distal tip and the bearing of the rotor . More speci fically, the functional section is provided proximal to the distal tip and distal to the bearing of the rotor .
  • the functional section may basically be cylindrical . In some embodiments , in the low-profile configuration, the functional section is substantially straight/extended . In this low-profile configuration, the functional section has its maximum length .
  • the functional section comprises an outward bulge and/or at least in part , protrudes outwardly from the distal tip and or is bulged outwardly .
  • the luminal gain can be increased .
  • the bulge may be formed in the centre of the functional section/ structure in the longitudinal direction .
  • the stator comprises an abutment , further optionally, a ring-shaped abutment , and the distal tube end abuts a proximal surface of the abutment , and the bearing abuts a distal surface of the abutment .
  • abutment improved connection between the distal tube end and the rotor, part of which is the bearing, is obtainable .
  • the stator may comprise a stop against which an inner surface of e . g . the distal tip of the rotor abuts when the functional section is in the large-profile configuration .
  • the stop may be a distal end of the stator .
  • the distal tip of the rotor abuts the distal part of the stator when the functional section is brought into the large- profile configuration .
  • this may define the maximum diameter of the functional section in the large- profile configuration . Put di f ferently, this may define the minimum length of the functional section .
  • the distal tip can be retracted by an operator until it abuts the stop, which defines the maximum retraction .
  • the present disclosure is also directed to an atherectomy system comprising a catheter of any of the preceding claims .
  • Figure 1 schematically depicts a cross-sectional view of a distal part of an atherectomy catheter in the low- profile configuration .
  • Figure 2 schematically depicts a cross-sectional view of distal part of an atherectomy catheter in the large-profile configuration .
  • Figure 3 schematically depicts a rotor of the disclosure .
  • Figure 4 schematically depicts an atherectomy system of the disclosure .
  • Figure 1 depicts an atherectomy catheter 1 having a tube 2 having a proximal end and a distal end 2a .
  • the catheter 1 further comprises a distal head 3 protruding from the distal tube end 2a in the distal direction D .
  • the distal direction is opposite the proximal direction P . Both directions may be referred to as axial or longitudinal direction .
  • the distal head 3 comprises a stator 4 which is stationary relative to the tube 2 and connected to the distal tube end 2a, and a rotor 5 .
  • the stator 4 protrudes in the distal direction D from the distal tube end 2a .
  • the rotor 5 is rotatable relative to the stator 4 and to the tube 2 .
  • the rotor 5 has a proximal end 5b and a distal tip 5a .
  • the rotor 5 is located outside the stator 4 .
  • the stator is , at least partially, received inside the rotor 5 .
  • the stator 4 and the rotor 5 are configured such that rotor is rotatable at a speed of at least 5 . 000 rpm around the stator 4 .
  • clot and/or calci fications can be removed, e . g . scratched, from a vessel wall (not shown) .
  • the outer surface of the rotor 5 may be considered to be in direct contact with a vessel (not shown) during a procedure .
  • the rotor 5 comprises a bearing 6 , the distal tip 5a and a functional section 7 .
  • the bearing 6 is provided at a proximal end 5b of the rotor 5 and rotatably supports the rotor 5 relative to the stator 4 .
  • the distal tip 5a comprises an abrasive surface 5- 1 to remove clot and/or calci fications from the vessel wall .
  • the abrasive surface may comprise a diamond coating .
  • the abrasive surface may be directed in the distal direction D and/or may be directed in a transverse direction orthogonal to the distal direction D .
  • the longitudinal direction runs in between the distal and proximal directions .
  • the functional section 7 is configured such that the rotor 5 assumes a low-profile configuration or a large-profile configuration, per the user ' s choice based on the anatomy ' s requirements .
  • the functional section 7 is substantially straight and has a first diameter dl and a first length 11 .
  • the large-profile configuration of the functional section 7 is shown in Figure 2 , in which the functional section 7 has a second length 12 and at least in one part of the functional section a second diameter d2 .
  • the second diameter d2 is the maximum diameter of the functional section 7 at one moment in time .
  • the large-profile configuration and in particular the second diameter d2 may change , so that the second diameter d2 being the maximum diameter per moment in time may change over time .
  • the first diameter dl is smaller than the second diameter d2 , and the first length 11 is longer than the second length 12 .
  • the length 11 of the functional section 7 is longer than the length 12 of the functional section 7 in the large-profile configuration, wherein the diameter dl in the low-profile configuration is smaller than the diameter d2 in the large-profile configuration .
  • the catheter 1 is configured such that transition from the low-profile configuration, as shown in Figure 1 , to the large-profile configuration, as shown in Figure 2 , is initiated by a reduction of the length from the first length dl to the second length d2 , and such that the transition represents , at the same time , and enlargement from the first diameter dl to the second diameter d2 .
  • the functional section 7 comprises a functional structure 7- 2 .
  • the functional structure 7-2 has a length 1 which remains the same in the low-profile and large-profile configurations . Speci fically, the overall length of the functional structure 7-2 is the same in the large-profile configuration as well as in the low-profile configuration .
  • the functional structure 7-2 is inelastic .
  • the functional structure 7-2 ( the functional section 7 ) is straight and extended .
  • the functional structure 7-2 ( the functional section 7 ) has an outward bulge , so that the functional section 7 comprising the outward bulge has a shorter length 12 .
  • the functional section protrudes from the remaining catheter and forms an outward bulge .
  • the functional section protrudes from the remaining catheter 1 , e . g . from the maximum diameter of the distal tip 5a in a radial/ transverse direction .
  • the additional diameter in the large-profile configuration shown in Figure 2 corresponds to the di f ference between d2 and dl .
  • a distal end 7a of the functional structure 7-2 is captured by the distal tip 5a of the rotor 5 .
  • the bearing 6 e . g . a ring
  • both ends of the functional structure 7-2 are captured by parts of the rotor .
  • the functional structure has a constant length 1 .
  • the length 11 of the functional section may correspond to the length of the functional structure 1 without the distal and proximal ends of the functional structure which are covered by the outer surface of the rotor .
  • the length 11 / 12 of the functional section may be defined by the length of the functional structure 1 which can contribute to the function - which is the outer surface of the functional structure 7 which is exposed by the remaining parts of the rotor 5 .
  • Figures 1 and 2 show that the stator 4 comprises at least one window 4a for entry of clot and/or calci fications into the tube 2 .
  • the rotor 5 has openings 7- 1 , namely in the functional section 7 .
  • the openings 7- 1 to allow clot and/or calci fication to pass through .
  • Figures 1 and 2 show a drive shaft 8 representing a torque cable .
  • the drive shaft 8 extends along the tube 2 , i . e . in the longitudinal direction, and connects to the distal tip 5a of the rotor 5 .
  • the drive shaft 8 is driven by a motor 15 which is proximal to the proximal end of the catheter tube 2 and is thereby rotated . Accordingly, the drive shaft 8 , which is connected to the rotor 5 , rotatably drives the rotor 5 .
  • the drive shaft 8 has a lumen to receive a guidewire 10 .
  • the drive shaft 8 and the guidewire 10 extend through a through- hole 11 formed in the distal tip 5a of the rotor 5 .
  • a helix 9 surrounds the drive shaft 8 and extends along an outer surface of the drive shaft 8 along the longitudinal direction .
  • the drive shaft 8 serves as an actuator for changing between the low-profile configuration of Figure 1 and the large- profile configuration of Figure 2.
  • the catheter 1 allows for retraction of the drive shaft 8 in the proximal direction P (longitudinal direction) so as to bring the functional section 7 in the large-profile configuration.
  • advancing the drive shaft 8, i.e. pushing the drive shaft in the distal direction D brings the functional section 7 in the low-profile configuration shown in Figure 2.
  • the functional structure 7-2 which is comprised in the functional section 7, comprises a memory metal, such as Nitinol.
  • the functional section i.e. the functional structure 7-2, comprises struts 7-5.
  • the struts 7-5 may be woven and/or perforated.
  • the struts 7-5 comprise cutting edges 7-3 which are configured to cut clot and/or calcifications from the vessel wall (not shown) .
  • the functional structure 7-2 is inelastic and represents a metal structure.
  • the metal structure has openings 7-1 as discussed above and cutting edges 7-4.
  • the functional section 7, i.e. the functional structure 7-2, is in the low-profile configuration, which corresponds to Figure 1.
  • the distal tip 5a of the rotor 5 has an abrasive surface 5-1, such as a diamond coating.
  • Multiple openings 7-1 are regularly distributed along the functional structure 7-2.
  • a cutting edge 7-4 is formed at the edges of a strut 7-5 of the functional structure 7-2.
  • the cutting edges 7-4 are configured to engage the clot/calcif ications in the vessel wall and act as cutters upon rotation of the rotor 5.
  • the bearing 6 is at least partially coated with ADLC on an inner bearing surface .
  • the opposite part namely the part of the stator 4 around which the rotor 5 and the bearing 6 rotate , may also comprise ADLC, so as to reduce wear and friction .
  • the bearing 6 may be made of stainless steel .
  • the distal tip 5a may be made of stainless steel . As can be taken from the Figures , the distal tip 5a is hood-shaped . Speci fically, the tip of the hood points in the distal direction D . This may help to advance the catheter 1 in the distal direction D .
  • the bearing 6 captures a distal end of the functional structure 7-2 , wherein the distal tip 5a captures the proximal end of the functional structure 7-2 .
  • the distal tip 5a and the bearing 6 are connected by means of the functional structure 7-2 .
  • the functional section 7 in the low-profile configuration, is basically cylindrical .
  • the functional section 7 represents an outward bulge .
  • the centre of the bulge may indicate the second diameter d2 , i . e . the diameter of the functional section 2 in the large-profile configuration .
  • the stator 4 comprises an abutment 4b, as shown in Figures 1 and 2 .
  • the abutment 4b may be ring-shaped, and the distal tube end 2a abuts a proximal surface of the abutment 4b, while the bearing 6 abuts a distal surface of the abutment 4b .
  • the abutment 4b may represent a proximal attachment or fixation of the rotor 5 relative to the catheter tube 2 as well as to the stator 4 .
  • the abutment 4b allows for fixing the proximal end of the rotor 5 , while allowing for rotation of the rotor 5 .
  • the stator 4 further comprises a stop 4c, which represents , as shown in Figures 1 and 2 , a distal end of the stator 4 .
  • the rotor 5 speci fically an inner surface of a distal tip of the rotor 5 , abuts against the stop 4c, when the functional section 7 is in the large-profile configuration or retracted so as to be brought in the large-profile configuration .
  • the stop 4c may be seen as a delimiter for delimiting the maximum retraction of the torque cable 8 and, hence , for determining the minimum length 12 of the functional section in the large-profile configuration .
  • FIG. 4 depicts an atherectomy system 12 of the disclosure .
  • the atherectomy system 12 comprises the atherectomy catheter 1 as described above , as well as a handle 13 having a housing 14 accommodating the motor 15 for rotatably driving the drive shaft 8 of the catheter 1 at its proximal end .
  • Fig . 4 also shows a collection bag 16 for collecting the removed clot/calci f ications/bodily fluid and an optional foot switch 17 for controlling the system 12 .
  • the abrasive surface on the distal tip 5a may help to advance the catheter 1 in the longitudinal direction D .
  • the drive shaft 8 can be retracted gradually, i . e . a gradual movement to obtain the large-profile configuration, up to the maximum large-profile configuration .
  • the low profile configuration may be beneficial
  • the large- profile configuration ( or successively larger diameters of large-profile configurations ) may be useful .
  • This trans formation from the low-profile to the large-profile configuration can be achieved by initiating the longitudinal movement ( retraction) of the drive shaft 8 by manipulation on the catheter handle 13 .
  • the catheter 1 When treating a chronic total occlusion ( CTO) , the catheter 1 may be used in a first step in its low-profile configuration to cross the lesion . In a second step of the procedure , the large-profile configuration may be used to achieve additional luminal gain before subsequent treatments, such as balloon dilation or stenting.
  • CTO chronic total occlusion

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  • Surgical Instruments (AREA)

Abstract

La divulgation concerne un cathéter (1) comprenant un tube (2) ayant une extrémité de tube proximale et une extrémité de tube distale (2a) et une tête distale (3) faisant saillie à partir de l'extrémité de tube distale (2a) dans la direction distale (D). La tête distale (3) comprend un stator (4) qui est fixe par rapport au tube (2) et relié à l'extrémité de tube distale (2a), et un rotor (5) qui peut tourner par rapport au stator (4) et au tube (2), et a une extrémité proximale (5b) et une pointe distale (5a). Le rotor (5) est situé à l'extérieur du stator (4), et le stator (4) et le rotor (5) sont configurés de telle sorte que le rotor (5) peut tourner à une vitesse d'au moins 5000 tr/min par rapport au stator (4). Le rotor (5) comprend un palier (6) au niveau de l'extrémité proximale (5b) du rotor pour un support rotatif par rapport au stator (4), la pointe distale (5a) comprenant au moins partiellement une surface abrasive (5-1) pour éliminer le caillot et/ou les calcifications d'une paroi de vaisseau. Une section fonctionnelle (7) est configurée de telle sorte que le rotor (5) peut adopter une configuration à profil bas dans laquelle la section fonctionnelle (7) est sensiblement droite et a un premier diamètre (d1) et une première longueur (l1), et une configuration à grand profil dans laquelle la section fonctionnelle a une seconde longueur (l2) et au moins dans une partie un second diamètre (d2), le premier diamètre (d1) étant plus petit que le second diamètre (d2), et la première longueur (l1) étant plus longue que la seconde longueur (l2), le cathéter étant configuré de telle sorte que la transition de la configuration à profil bas à la configuration à grand profil est initiée par une réduction de la longueur de la première longueur à la seconde longueur, et de telle sorte que ladite transition représente, en même temps, un agrandissement du premier diamètre au second diamètre.
PCT/EP2023/068207 2023-07-03 2023-07-03 Cathéter d'athérectomie et système d'athérectomie Ceased WO2025008042A1 (fr)

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PCT/EP2023/068207 WO2025008042A1 (fr) 2023-07-03 2023-07-03 Cathéter d'athérectomie et système d'athérectomie

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Application Number Priority Date Filing Date Title
PCT/EP2023/068207 WO2025008042A1 (fr) 2023-07-03 2023-07-03 Cathéter d'athérectomie et système d'athérectomie

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Publication number Priority date Publication date Assignee Title
US20240081991A1 (en) * 2021-02-10 2024-03-14 Capstan Medical Inc. Systems, devices and methods for delivery systems

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US5836868A (en) * 1992-11-13 1998-11-17 Scimed Life Systems, Inc. Expandable intravascular occlusion material removal devices and methods of use
US20030055445A1 (en) * 2000-03-31 2003-03-20 Bacchus Vascular, Inc. Expansible shearing catheters for thrombus and occlusive material removal
US20060229645A1 (en) * 2005-04-07 2006-10-12 Possis Medical, Inc. Cross stream thrombectomy catheter with flexible and expandable cage
EP4079239A1 (fr) * 2021-04-22 2022-10-26 Vetex Medical Ltd. Dispositif de thrombectomie

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Publication number Priority date Publication date Assignee Title
US5836868A (en) * 1992-11-13 1998-11-17 Scimed Life Systems, Inc. Expandable intravascular occlusion material removal devices and methods of use
US20030055445A1 (en) * 2000-03-31 2003-03-20 Bacchus Vascular, Inc. Expansible shearing catheters for thrombus and occlusive material removal
US20060229645A1 (en) * 2005-04-07 2006-10-12 Possis Medical, Inc. Cross stream thrombectomy catheter with flexible and expandable cage
EP4079239A1 (fr) * 2021-04-22 2022-10-26 Vetex Medical Ltd. Dispositif de thrombectomie

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20240081991A1 (en) * 2021-02-10 2024-03-14 Capstan Medical Inc. Systems, devices and methods for delivery systems

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