WO2024099325A1 - 输送器及脑栓塞保护系统 - Google Patents

输送器及脑栓塞保护系统 Download PDF

Info

Publication number
WO2024099325A1
WO2024099325A1 PCT/CN2023/130272 CN2023130272W WO2024099325A1 WO 2024099325 A1 WO2024099325 A1 WO 2024099325A1 CN 2023130272 W CN2023130272 W CN 2023130272W WO 2024099325 A1 WO2024099325 A1 WO 2024099325A1
Authority
WO
WIPO (PCT)
Prior art keywords
handle
sheath core
conveyor
sheath
proximal end
Prior art date
Application number
PCT/CN2023/130272
Other languages
English (en)
French (fr)
Inventor
刘建勇
Original Assignee
先健科技(深圳)有限公司
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 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Publication of WO2024099325A1 publication Critical patent/WO2024099325A1/zh

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • 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
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve

Definitions

  • the present application relates to the technical field of interventional medical devices, and in particular to a delivery device and a cerebral embolism protection system.
  • Cerebral embolism refers to various emboli in the blood (such as mural thrombi in the heart, atherosclerotic plaques, fat, tumor cells, fibrocartilage or air, etc.) that enter the narrower and more curved cerebral arteries with the blood flow and block the blood vessels.
  • emboli in the blood
  • the collateral circulation cannot compensate, it causes ischemic necrosis of brain tissue in the arterial blood supply area and focal neurological deficits.
  • Cerebral embolism often occurs in the internal carotid artery system and is relatively rare in the vertebral-basilar artery system. Cerebral embolism accounts for about 15% to 20% of ischemic strokes. About 75% of cardiogenic emboli embolize in the brain.
  • valve replacement surgery mainly refers to transcatheter aortic valve implantation (TAVI), which inserts an interventional catheter through the femoral artery to deliver the artificial heart valve to the aortic valve area and open it, thereby completing the artificial valve implantation and restoring valve function.
  • TAVI transcatheter aortic valve implantation
  • the operation does not require thoracotomy, so the trauma is small and the recovery after surgery is fast.
  • Valve replacement surgery is used in conjunction with an anti-embolism protection device (thrombus filter) to effectively prevent emboli from entering the skull and causing blockage, further reducing the risk of stroke.
  • thrombus filter anti-embolism protection device
  • the three branch vessels of the aortic arch need to effectively filter emboli.
  • the thrombus filter in the cerebral embolism protection device must be released and adjusted to the corresponding positions of the three branch vessels.
  • the thrombus filter must fit the curvature of the aortic arch so that the thrombus filter and the three branch vessels can filter emboli.
  • the cerebral embolism protection system must be kept stationary to prevent the cerebral embolism protection device from shifting or deflecting during the operation, causing the cerebral embolism protection device to fail to effectively fit the aortic arch, causing emboli to leak into the three branch vessels, causing the risk of stroke.
  • space is reserved in one of the handles for the relative movement of the other handle, so that part of the sheath core is in a suspended state.
  • the axial thrust applied to make the handles move relative to each other may cause the sheath core to twist, which makes the sheath core in an unstable state after the self-expanding material is fully self-inflated, and the twisted unstable state cannot be eliminated when the thrombus filter is adjusted to the corresponding position of the three branch vessels after the release, resulting in the thrombus filter still being in an unstable state after being adjusted to fit the three branch vessels.
  • the thrombus filter is twisted and recovered, resulting in emboli leakage, flowing into the three branch vessels, causing the risk of stroke.
  • a delivery device and a cerebral embolic protection system are provided.
  • the present application provides a conveyor for conveying a self-expanding material, the conveyor comprising a handle assembly, a sheath core and a sheath tube, and the sheath core is inserted through the handle assembly and the sheath tube; the proximal end of the sheath tube is connected to the distal end of the handle assembly, the handle assembly comprises a first handle and a second handle, the proximal end of the sheath core is fixedly connected to the proximal end of the second handle, the first handle and the second handle are mutually sleeved, and the first handle and the second handle can slide relative to each other, so that the sheath tube moves axially relative to the sheath core, the handle assembly also comprises a protective structure arranged around the sheath core, and during the self-expansion process of the self-expanding material, the distal end of the protective structure is accommodated in the handle assembly.
  • the second handle is sleeved on the outside of the first handle, and the protective structure is arranged in the second handle.
  • the protective structure includes a fixed rod or a sliding rod, and the fixed rod or the sliding rod is arranged around the sheath core.
  • the second handle includes a hollow second rod body
  • the conveyor includes an initial state when the self-expanding substance is not released.
  • the distance between the inner side of the proximal end of the second handle and the proximal end of the first handle is L1
  • the length of the protective structure is defined as L
  • the length L of the protective structure satisfies: L ⁇ L1.
  • a seal is provided between the distal end of the first handle and the sheath core, and the conveyor also includes a release state in which the self-expanding material is fully expanded.
  • the conveyor is in the release state, the distance between the inner side of the proximal end of the second handle and the proximal end of the seal is L2, and the protective structure L satisfies: L ⁇ L2.
  • the protection structure is a slidably connected structure relative to the sheath core, so that the protection structure can move relatively axially along the sheath core.
  • a slide button is provided at the proximal end of the protection structure, and a slide groove is provided along the axial direction of the second handle, and the slide button is exposed from the slide groove.
  • the protective structure is fixed to the sheath core.
  • a Y-shaped connector is disposed in the distal end of the first handle, and the Y-shaped connector includes a first channel along the axial direction and a second channel along the oblique direction.
  • the first handle is provided with a guide structure along the axial direction
  • the second handle is correspondingly provided with a slide
  • the slide cooperates with the guide structure.
  • the slide slides axially relative to the guide structure.
  • the present application also provides a cerebral embolism protection system, which includes a thrombus filter and a conveyor as described above, wherein the conveyor is used to convey the thrombus filter.
  • a technical effect of an embodiment of the present application is: the present application provides a delivery device for a cerebral embolism protection system, which can effectively reduce the sheath core twisting that may be caused by the axial thrust applied by the relative movement of the first handle and the second handle during the release process of the thrombus filter, thereby reducing the possibility of the sheath core being in an unstable state after the self-expanding material is fully self-inflated, thereby reducing the risk of stroke.
  • FIG1 is a perspective view of a conveyor according to Example 1 provided by the present application (initial state);
  • FIG2 is an exploded view of FIG1 (with the sheath core omitted);
  • Fig. 3 is a cross-sectional view along the A-A direction in Fig. 1 (initial state);
  • FIG4 is an enlarged view of point B in FIG3 ;
  • FIG5 is a cross-sectional view of the conveyor in Example 1 provided by the present application in a released state
  • FIG6 is a cross-sectional view of the initial state of the conveyor with a protective structure according to Example 1 provided by the present application;
  • FIG7 is a schematic diagram of the delivery device in Example 1 provided by the present application releasing the thrombus filter and attaching it to the aortic arch;
  • FIG8 is a cross-sectional view of the conveyor of Example 2 provided by the present application in an initial state
  • FIG9 is an enlarged view of point C in FIG8 ;
  • FIG10 is a cross-sectional view of the conveyor of Example 2 provided by the present application in a released state
  • FIG11 is a perspective view of the conveyor of Example 3 provided by the present application (initial state);
  • FIG12 is a cross-sectional view of the conveyor of Example 3 provided in the present application in an initial state
  • FIG13 is a cross-sectional view of the conveyor of Example 3 provided by the present application in a released state
  • FIG14 is an enlarged view of point D in FIG13;
  • FIG15 is a cross-sectional view of the conveyor of Example 3 provided by the present application when the slide button is pushed to the far end of the slide groove;
  • Figure 16 is an enlarged view of point E in Figure 15.
  • distal end and proximal end are defined here.
  • the above terms are commonly used in the field of interventional medical devices. Specifically, the “distal end” refers to the end away from the operator during the operation, and the “proximal end” refers to the end close to the operator during the operation.
  • Axial generally refers to the length direction of the medical device when it is transported
  • circumferential generally refers to the direction around the “axial direction”
  • radial generally refers to the direction of the medical device that is perpendicular to its “axial direction” and passes through the central axis
  • the "axial” and “radial” of any component of the medical device are defined based on this principle.
  • self-expanding materials are generally elastomers with self-expanding properties formed by heat setting. They can undergo radial deformation and are generally in a state of radial compression and contracted within the sheath during delivery. When the radial restraining force is released, the self-expanding material can undergo elastic deformation back to the predetermined state due to its own self-expanding properties.
  • Embodiment 1 provides a delivery device 100, as shown in FIGS. 1-7, for use in a cerebral embolism protection system, wherein a thrombus filter 90 is implanted into a blood vessel to filter particles or granules such as thrombi or calcifications, and in conjunction with a valve replacement surgery, for example, the delivery device is used to release the thrombus filter 90 at the location of the aortic arch and fit the three branch openings of the aortic arch to prevent particles such as thrombi or lumps in the blood flow from flowing into the brain through any of the three branches of the aortic arch, thereby avoiding the occurrence of cerebral embolism, as shown in FIG. 1-3 in combination with FIG.
  • the delivery device 100 includes a handle assembly 10, a sheath core 60, The sheath tube 80 and the guide head 70, wherein the sheath core 60 is sequentially inserted into the handle assembly 10 and the sheath tube 80 from the proximal end to the distal end, and the guide head 70 is arranged at the distal end of the sheath core 60, for guiding the conveyor 100 to intervene in the human body.
  • the handle assembly 10 includes a first handle 11 and a second handle 12, the proximal end of the sheath 80 is connected to the distal end of the first handle 11, the proximal end of the sheath core 60 is fixedly connected to the proximal end of the second handle 12, the first handle 11 and the second handle 12 are mutually socketed, and the first handle 11 and the second handle 12 can slide relative to each other, so that when the first handle 11 moves axially toward the proximal end relative to the second handle 12, the first handle 11 can drive the sheath 80 to move axially toward the proximal end relative to the sheath core 60, thereby allowing the thrombus filter 90 fixed to the distal end of the sheath core 60 to break away from the restraint of the sheath 80 at the distal end of the conveyor 100 and be released.
  • the first handle 11 includes an end cap 111, a joint assembly 112, a shell 113 arranged around the joint assembly 112, and a first rod body 114 connected to the proximal end of the shell 113.
  • the end cap 111, the joint assembly 112 and the first rod body 114 are axially provided with a through hole for the sheath core 60 to pass through.
  • the distal end of the joint assembly 112 is fixedly connected to the proximal end of the sheath tube 80 by a nut 115, and a seal 116 is arranged between the joint assembly 112 and the sheath core 60.
  • the distal end of the connector assembly 112 has a taper.
  • a slight taper can be set at the proximal opening of the sheath 80 to fit the distal taper of the connector assembly 112.
  • the distal end of the connector assembly 112 is provided with an external thread, which is then threadedly fixed to the connector assembly 112 with an external thread through a nut 115 with an internal thread.
  • the connector assembly 112 is a Y-type connector, which includes a first channel along the axial direction and a second channel 1123 along the oblique direction relative to the first channel 1121.
  • the first channel 1121 is a sheath core channel for the sheath core 60 to pass through
  • the second channel 1123 is a pigtail catheter channel for the pigtail catheter to pass through during angiography and pass out from the distal end of the sheath tube.
  • the axial sheath core channel and the oblique pigtail catheter channel form a Y shape
  • an exhaust valve channel 1122 is also provided on the Y-type connector.
  • the second channel extends from its connection with the first channel toward the proximal direction and gradually moves away from the first channel, so that the pigtail catheter can extend into the first channel along the second channel and then extend toward the distal end of the first channel.
  • the exhaust valve channel 1122 is arranged on the opposite side of the pigtail conduit channel and is arranged radially.
  • the exhaust valve channel is connected to the three-way valve through the conduit.
  • the setting direction and setting position of the exhaust valve channel are not limited. It can be arranged radially or obliquely, on a Y-shaped joint, or at other positions of the handle assembly, as long as the exhaust function can be achieved.
  • the proximal end of the sheath 80 is fixed to the axial distal end of the Y-type connector by a nut 115 and is connected to the Y-type connector, so that the Y-type connector is arranged at the distal end of the first handle, which facilitates the pigtail catheter to pass through the second channel into the first channel for angiography.
  • Two opposite half shells 113 are provided on the outside of the Y-type connector, and a groove matching the shape of the exhaust valve channel combined with the Y-type connector is provided inside the shell 113.
  • the distal end of the shell 113 is provided with an external thread, and the end cap 111 is correspondingly provided with an internal thread.
  • the distal ends of the two opposite half shells 113 are fixed to the end cap 111 by internal and external threads, and the proximal ends are fixed by locking screws; the exhaust valve channel 1122 is externally connected to the three-way valve 118; a pigtail catheter channel is provided through the Y-type connector, and a pigtail catheter can be used to enter from the pigtail catheter channel of the Y-type connector and perform angiography at the aortic arch to observe the fit of the thrombus filter.
  • the pigtail catheter can also be used to pass through the aortic arch and reach the position of the calcified aortic valve for angiography, so that when the cerebral embolism protection system including the conveyor 100 performs brain protection during aortic valve replacement, there is no need to add an additional access for angiography, which can reduce the operation time and reduce the surgical risk.
  • a locking nut 117 is provided on the proximal side of the seal 116, and the seal 116 is arranged between the proximal end of the Y-type connector and the locking nut 117.
  • the sheath core 60 passes through the avoidance holes of the seal 116 and the locking nut 117 respectively, and the seal 116 is squeezed and fixed axially by the locking nut 117 to achieve a sealing effect to prevent blood leakage. At the same time, it will not cause too much resistance when the relative movement between the sheath core 60 and the first handle 11 is generated, that is, it will not affect the relative movement of the sheath core 60 and the first handle 11.
  • the first rod body 114 includes an embedding portion 1141 located at the distal end, and an embedding groove 1131 is correspondingly provided on the inner side of the proximal end of the shell 113.
  • the shape of the embedding groove 1131 matches the shape of the embedding portion 1141, and the cross-section of the embedding portion 1141 is in the shape of an "I", so that the first rod body 114 is fixed in the axial direction relative to the shell 113.
  • the middle recess of the embedding portion 1141 can be set to a hexagonal structure or other non-circular structure.
  • a limit piece can also be set in the circumferential direction, as long as the purpose of preventing the first rod body 114 from rotating circumferentially relative to the shell 113 is ultimately achieved, thereby preventing the risk of circumferential movement when the first rod body 114 and the second rod body move relative to each other in the axial direction, thereby preventing the sheath core from twisting due to the risk of circumferential movement.
  • the first rod body 114 also includes a guide structure extending along the axial direction for contacting with the second handle It plays a guiding role during relative motion, and the guiding structure can be set as a guiding groove 1142.
  • the second handle 12 is sleeved on the outside of the first handle 11.
  • the second handle 12 is a second rod body sleeved on the outside of the first rod body 114.
  • the second rod body is a hollow rod body.
  • the second rod body is provided with a slide 121.
  • the first rod body can also be set as a hollow rod body, and the first rod body can be sleeved on the outside of the second rod body to achieve relative sliding of the first handle and the second handle.
  • the slide 121 is a ball plunger arranged radially, and the distal end of the second rod body is radially provided with a thread corresponding to the position of the guide groove 1142.
  • the ball plunger is locked into the second rod body along the thread, and at the same time, one end of the ball plunger is embedded in the guide groove 1142 of the first rod body 114.
  • the embedded end of the ball plunger can slide axially in the guide groove 1142 as the first rod body 114 and the second rod body slide relative to each other, preventing the second rod body and the first rod body 114 from rotating relative to each other in the circumferential direction during the axial relative movement, so that during the axial back-and-forth relative movement of the second rod body and the first rod body 114, the sheath core 60 will not twist in the circumferential direction, thereby realizing the directional sliding of the second handle 12 relative to the first handle 11.
  • the setting of the guide groove 1142 can reduce the circumferential rotation of the sheath core 60, thereby achieving a smooth release of the self-inflated material in a specific direction, and further reducing the self-twisting of the sheath core 60 caused by the relative circumferential rotation between the first handle and the second handle, so that after the valve replacement surgery begins, the cerebral embolism protection system is always in a stable state, further reducing the possibility of embolic leakage and preventing cerebral stroke.
  • the thrombus filter 90 As shown in FIG. 7 in combination with FIG. 1-5 , after the thrombus filter 90 is completely released, it is generally necessary to slightly adjust the blood vessel thrombus filter 90 to fit the aortic arch before performing valve replacement.
  • the twisting of the sheath core 60 may cause the sheath core 60 to remain in an unstable state after the thrombus filter 90 is fitted to the aortic arch by adjusting the conveyor.
  • the conveyor of the thrombus filter 90 is affected by external environmental factors, causing the unstable state of the sheath core 60 to change to a stable state, thereby causing the blood vessel filter to change from a state of fitting to the aortic arch during valve replacement to a non-fitting state, which in turn causes emboli to leak into branch vessels, creating a risk of stroke.
  • the proximal end of the second handle 12 is fixed to the proximal end of the sheath core 60 by a fastener 13, so that when the second handle 12 and the first handle 11 slide relative to each other in the axial direction, the sheath tube 80 moves proximally relative to the sheath core 60, and the distal end of the sheath core 60 is connected to the thrombus filter 90.
  • the movement realizes the release and recovery of the thrombus filter 90 in the sheath tube 80.
  • the conveyor further comprises a fastener 13, the distal end of the fastener 13 is tapered and can be tightened radially by being squeezed, a fixing hole for the sheath core 60 to penetrate is provided in the fastener 13, a tapered hole structure adapted to the distal end of the fastener 13 is provided at the proximal end of the second handle 12, the proximal end of the sheath core 60 penetrates into the fixing hole of the fastener 13, and the distal end of the fastener 13 is embedded in the tapered hole at the proximal end of the second handle 12, thereby realizing the fixed connection between the sheath core 60 and the second handle 12 through the fastener 13.
  • the handle assembly further includes a protective structure 14 disposed around the sheath core 60.
  • the protective structure 14 is used to protect the sheath core 60 during the relative movement between the first handle 11 and the second handle 12, so as to prevent the sheath core from twisting due to the axial thrust on the second handle 12 during the release of the self-expanding material, thereby preventing the sheath core from being in an unstable state after the self-expanding material self-expands.
  • the protection structure 14 disposed in the second handle 12 is a hollow fixing rod, which is disposed around the sheath core 60, and the outer diameter of the fixing rod is smaller than the inner diameter of the first rod body 114 so that when the second handle 12 moves relative to the first handle 11 in the axial direction, the fixing rod can enter the hollow axial hole of the first rod body 114, thereby preventing the setting of the fixing rod from affecting the movement of the second handle 12 relative to the first handle 11, thereby affecting the release of the thrombus filter 90.
  • the fastener 13 is disposed at the proximal end of the second handle 12, and the fixing rod surrounds the sheath core 60, and the proximal end of the sheath core 60 is slightly exposed from the proximal end of the fixing rod.
  • the proximal ends of the fixing rod and the sheath core 60 both extend into the fixing hole of the fastener 13, and the distal end of the fastener 13 is embedded in the proximal conical hole of the second handle 12, fastening the fixing rod and the proximal end of the sheath core 60, thereby fixing the fixing rod and the sheath core 60 together with the proximal end of the second handle 12.
  • the portion of the sheath core 60 between the second handle 12 and the proximal end of the first handle 11 is in a suspended state.
  • the portion of the sheath core 60 in a suspended state is defined as a suspended segment.
  • the circumferential torsion of the sheath core 60 can easily cause the thrombus filter 90 to remain in an unstable state of circumferential torsion after being released and adjusted to fit the aortic arch.
  • the fixing rod is arranged around the sheath core 60, and the fixing rod is arranged at the first During the relative movement of the second handle 12 and the first handle 11 , the fixing rod moves with the sheath core 60 relative to the first handle 11 , which can reduce the risk of twisting of the sheath core 60 .
  • the conveyor includes an initial state when the self-expanding substance has not been released (as shown in FIG. 3 ) and a released state when the self-expanding substance is fully expanded (as shown in FIG. 5 ).
  • the length of the suspended section in the axial direction is the largest.
  • the self-expanding substance is gradually released, the length of the suspended section gradually decreases until the self-expanding substance is in the released state when it is fully expanded.
  • the distal end of the protective structure is always contained in the handle assembly.
  • the present embodiment also provides a cerebral embolism protection system including the above-mentioned conveyor 100, and the cerebral embolism protection system also includes a thrombus filter 90.
  • the thrombus filter 90 has superelasticity and shape memory characteristics, is fixed at the distal end of the sheath core 60, can be loaded in the sheath tube 80 of the above-mentioned conveyor 100 after compression, and is in a compressed state in the interval space between the sheath tube 80 and the sheath core 60, so that the thrombus filter 90 can be delivered to a predetermined position in the body by means of the conveyor 100, and then released and unfolded to fit the aortic arch.
  • the thrombus filter 90 When the thrombus filter 90 extends out of the sheath tube 80 under the relative movement of the second handle 12 and the first handle 11, the positions of the thrombus filter 90 and the sheath core 60 relative to the three branch vessels of the aortic arch are shown in FIG. 7.
  • the unfolded state of the thrombus filter 90 which is self-expanded and unfolded under the action of the shape memory characteristic, is substantially consistent with the shape of the aortic arch, conforming to the shape of the aortic arch, and achieving better fit.
  • a thrombus filter 90 is fixed at a suitable position at the distal end of the sheath core 60 of the conveyor 100.
  • the proximal end or the distal end of the thrombus filter 90 is fixed to the sheath core 60.
  • the thrombus filter 90 can be released from or recovered into the sheath tube 80 as the sheath core 60 moves axially relative to the sheath tube 80.
  • a puncture is performed on one side of the femoral artery of a human or animal body, and then a guide wire is inserted to establish an in vivo delivery channel; after the guide wire reaches the predetermined position, the sheath tube 80 containing the thrombus filter 90 is delivered to the area where the aortic arch is located along the guide wire channel.
  • DSA Digital subtraction angiography
  • the aortic arch is protected.
  • the second handle 12 is held stationary, and the first handle 11 is withdrawn to drive the sheath 80 backward, thereby gradually releasing the thrombus filter 90 from the sheath 80, until the entire thrombus filter 90 is completely exposed from the distal end of the sheath 80, and the thrombus filter 90 is self-expanded and expanded to cover the openings of the three branch blood vessels of the aortic arch so that the thrombus filter 90 fits the aortic arch; then, a pigtail catheter is used to enter and pass through the aortic arch from the pigtail catheter channel 1123 of the Y-type connector to reach the position of the calcified aortic valve for angiography; during the replacement process, the calcified tissue, emboli and other particles or microparticles will flow toward the aortic arch with the blood flow.
  • the thrombus filter 90 since the thrombus filter 90 has formed a strict filtering mechanism at the branch vessel openings of the three branch vessels of the aortic arch, floating objects such as emboli and calcified tissues are filtered by the thrombus filter 90 and deflected to the descending aorta with the blood flow, thereby preventing these floating objects from flowing into the brain through the three branch vessels; after the aortic valve replacement is completed, the aortic replacement valve sheath 80 is withdrawn; then the sheath 80 of the cerebral embolism protection system is pushed toward the distal end so that the thrombus filter 90 is accommodated in the distal end of the sheath 80, and then the thrombus filter 90 is withdrawn from the body together with the sheath 80, thereby completing the operation.
  • Embodiment 2 proposes another conveyor 200 and a cerebral embolic protection system, as shown in Figures 8-10.
  • the features of the conveyor 200 of Embodiment 2 that are the same as or can be used in the conveyor 100 of Embodiment 1 are not described in detail here.
  • the main difference is that in the conveyor 200 of Embodiment 2, as shown in Figure 8, when the conveyor 200 is in the initial state, the distance between the inner side of the proximal end of the second handle 22 and the proximal end of the first handle 21 is defined as L1, that is, L1 is the maximum value of the axial length of the suspended section, and the length of the fixed rod 24 is defined as L, then the length L of the fixed rod 24 satisfies: L ⁇ L1.
  • the sheath core 60 is relatively thin, if the suspended section has no support in the radial direction, the sheath core 60 is easily bent or twisted circumferentially due to the axial thrust. The bending or circumferential twisting can easily cause the sheath core 60 to be in an unstable state of curling or twisting.
  • the fixing rod 24 extends distally along the sheath core 60 to the proximal end of the first handle 21 or inside the first handle 21, so that during the entire process of relative movement between the first handle 21 and the second handle 22, the sheath core 60 between the second handle 22 and the first handle 21 is always under the protection of the fixing rod 24, so as to reduce the risk of bending or twisting of the sheath core 60, and at the same time, the thrombus filter 90 is smoothly released at the predetermined position, so as to prevent the sheath core 60 from being twisted circumferentially due to the thrust.
  • the sheath core 60 When the thrombus filter 90 is released and adjusted to fit the aortic arch, the sheath core 60 is still in an unstable state, thereby preventing Instability of the cerebral embolic protection system during valve replacement surgery leads to the possibility of embolic leakage, thereby preventing stroke.
  • Embodiment 3 proposes another conveyor 300 and a cerebral embolic protection system.
  • the conveyor 300 of embodiment 3 and the conveyor 100 of embodiment 1 that are the same or can be used in the features are not repeated here.
  • the main difference is that, in the conveyor 300 of embodiment 3, as shown in Figures 11-16, a slide bar 34 is provided in the second handle 32, and the slide bar 34 is a slidable connection structure relative to the sheath core 60.
  • the slide bar 34 is arranged around the sheath core 60, and a slide button 35 is provided at the proximal end of the slide bar 34.
  • a slide groove 322 is axially provided on the second handle 32, so that the slide button 35 is exposed outside the second handle 32 through the slide groove 322, so that the slide button 35 can be used to drive the slide bar 34 to slide along the slide groove 322.
  • the second handle 32 Since the second handle 32 is sleeved on the outside of the first handle 31 and the second handle 32 and the first handle 31 need to slide relative to each other, a space for the relative movement of the first handle 31 needs to be reserved in the hollow second handle 32.
  • the part of the sheath core 60 between the second handle 32 and the proximal end of the first handle 31 is in a suspended state.
  • the part of the sheath core 60 in the suspended state is defined as a suspended section. Under the thrust of the relative movement between the first handle 31 and the second handle 32, since the sheath core 60 is thin and the suspended section has no support in the radial direction, the suspended section has the risk of bending, breaking or circumferential twisting.
  • the bending or twisting of the sheath core 60 easily makes the thrombus filter 90 still in an unstable state of bending or circumferential twisting when it is adjusted to fit the aortic arch after release.
  • the slide bar 34 is arranged around the sheath core 60. In the process of relative movement between the second handle 32 and the first handle 31, the slide bar 34 moves relative to the first handle 31 together with the sheath core 60, which can reduce the risk of bending or twisting of the suspended section.
  • the conveyor 300 includes an initial state when the self-expanding substance to be self-expanded has not been released (as shown in FIG. 12 ) and a released state when the self-expanding substance to be self-expanded is fully expanded (as shown in FIG. 13 ).
  • the conveyor 300 when the conveyor 300 is implanted and reaches a predetermined position and is in an initial state where the self-expanding substance to be self-expanded has not yet been released, the length of the suspended section in the axial direction is the largest.
  • the length of the suspended section gradually decreases until the self-expanding substance to be self-expanded is in a released state where the self-expanding substance is fully expanded.
  • the distance between the inner side of the proximal end of the second handle 32 and the proximal end of the first handle 31 is defined as L1, that is, L1 is the maximum axial length of the suspended section. value, and the length of the slide bar 34 is defined as L, then the length L of the slide bar 34 satisfies: L ⁇ L1. Since the sheath core 60 is relatively thin, if the suspended section has no support in the radial direction, the sheath core 60 is easily bent or twisted circumferentially due to the axial thrust, and the bending or circumferential twisting easily puts the sheath core 60 in an unstable state of curling or twisting.
  • the slide bar 34 When the length L of the slide bar 34 is ⁇ L1, the slide bar 34 extends distally along the sheath core 60 to the proximal end of the first handle 31 or inside the first handle 31, so that during the entire process of relative movement between the first handle 31 and the second handle 32, the sheath core 60 between the second handle 32 and the first handle 31 is protected by the slide bar 34 to reduce the risk of bending or breaking of the sheath core 60, so that the thrombus filter 90 is smoothly released at the predetermined position.
  • the sheath core 60 is prevented from bending due to thrust or circumferential twisting due to thrust.
  • the sheath core 60 When the thrombus filter 90 is released and adjusted to fit the aortic arch, the sheath core 60 is still in an unstable state, thereby preventing the possibility of embolic leakage caused by the instability of the cerebral embolism protection system during valve replacement surgery, thereby preventing cerebral stroke.
  • the thrombus filter 90 connected to the distal end of the sheath core 60 is exposed outside the sheath tube 80.
  • the sheath core 60 of the cerebral embolic protection device is thin and slightly soft, the thrust in the axial direction caused by the relative movement between the first handle 31 and the second handle 32 will cause the sheath core 60 to bend or twist circumferentially. Since the sheath core 60 is inside the handle and the sheath tube 80, the sheath core 60 twists itself under the thrust before the aortic valve implantation begins. Adjustment of the position of the thrombus filter 90 often fails to restore it.
  • the sheath core 60 automatically rotates due to the bending part or its own circumferential twist caused by the above-mentioned thrust (that is, the sheath core 60 changes from an unstable state to a stable state) under the influence of external environmental factors, the vascular filter will change from a state of being fitted to the aortic arch before the valve replacement surgery to a non-fitting state, thereby causing the thrombus filter 90 to shift or deflect, and then causing the embolus to leak into the branch vessels, creating the risk of stroke.
  • the distance between the inner side of the proximal end of the second handle 32 and the proximal end of the seal 316 is defined as L2, and the length L of the slide bar 34 satisfies: L ⁇ L2.
  • the first rod body 314 of the first handle 31 and the second rod body of the second handle 32 are sleeved, there must be an overlap between the two rod bodies, and there is an overlap between the first rod body 314 of the first handle 31 and the housing 313 outside the Y-shaped joint. (For example, an embedded portion).
  • L2 must be greater than L1.
  • L1 ⁇ L ⁇ L2 the length of the slide rod 34 satisfies: L1 ⁇ L ⁇ L2
  • the sheath core 60 of the suspended section is always under the protection of the slide rod 34, which can reduce the risk of bending or circumferential twisting of the sheath core 60;
  • the slide rod 34 is in the released state of the self-expanding object to be fully expanded, the distal end of the slide rod 34 has not yet touched or has just touched the seal 316, that is, the seal 316 will not generate additional resistance to the entire release process of the self-expanding object, so that the entire release process of the thrombus filter 90 is in a stable release state, thereby reducing surgical risks.
  • the slide bar 34 is provided as a slidable connection structure relative to the sheath core 60.
  • the slide button 35 can be pushed forward to drive the slide bar 34 to continue to move toward the distal end.
  • the slide groove 322 extends from the proximal end of the second handle 32 to the distal end of the second handle 32, as shown in Figures 13-16 combined with Figure 11, and the proximal end of the slide groove 322 is closed.
  • the slide bar 34 is pushed toward the distal end along the sheath core 60 along with the slide button 35 until the slide button 35 is pushed from the proximal end of the slide groove 322 to the distal end of the slide groove 322 (at this time, the sheath core of the conveyor is in a straight state), and the distal end of the slide bar 34 enters the sheath tube 80, which is conducive to using the slide bar 34 to straighten the sheath core 60, so that the curved part of the sheath core 60 caused by the thrust or the twisting of the sheath core 60 itself is turned back to a straight state.
  • the thrombus filter 90 is adjusted to be in a fit state with the aortic arch before the aortic valve implantation is started. This can prevent the thrombus filter 90 from being offset or deflected due to the automatic rotation of the sheath core 60 during the aortic valve implantation, thereby ensuring that the thrombus filter 90 remains stable during the aortic implantation, thereby reducing the risk of embolus leakage.

Landscapes

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

Abstract

一种输送器及脑栓塞保护系统，输送器包括手柄组件、鞘芯和鞘管，且鞘芯穿设于手柄组件和鞘管；鞘管的近端与手柄组件的远端连接，手柄组件包括第一手柄和第二手柄，鞘芯的近端与第二手柄的近端固定连接，第一手柄与第二手柄相互套接，且第一手柄与第二手柄可相对滑动，使得鞘管相对鞘芯沿轴向运动，手柄组件还包括围绕鞘芯设置的保护结构，且在自膨物的自膨胀过程中，保护结构的远端收容于手柄组件内。

Description

输送器及脑栓塞保护系统
相关申请的交叉引用
本申请要求于2022年11月07日提交中国专利局、申请号为2022113828467、发明名称为“输送器及脑栓塞保护系统”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及介入医疗器械技术领域，特别是涉及一种输送器及脑栓塞保护系统。
背景技术
脑栓塞是指血液中的各种栓子(如心脏内的附壁血栓、动脉粥样硬化的斑块、脂肪、肿瘤细胞、纤维软骨或空气等)随血流进入较为狭窄、弯曲的脑动脉而阻塞血管，当侧支循环不能代偿时，引起该动脉供血区脑组织缺血性坏死，出现局灶性神经功能缺损。脑栓塞常发生于颈内动脉系统，椎-基底动脉系统相对少见。脑栓塞约占缺血性脑卒中的15％～20％。约75％的心源性栓子栓塞于脑部，引起脑栓塞的常见的心脏疾病有心房颤动、心脏瓣膜病、感染性心内膜炎、心脏粘液瘤等。随着医疗水平的提高，越来越多的心脏和血管外科问题可通过血管内手术完成。支架植入术、瓣膜置换术等均是近年来发展迅速的血管内手术。其中瓣膜置换术主要为经导管主动脉瓣置入术(Transcatheter Aortic Valve Implantation，TAVI)，通过股动脉送入介入导管，将人工心脏瓣膜输送至主动脉瓣区打开，从而完成人工瓣膜置入，恢复瓣膜功能。手术无需开胸，因而创伤小、术后恢复快。瓣膜置换术配合防栓塞的保护装置(血栓过滤器)使用，有效防止栓子进入颅内造成堵塞，进一步降低脑卒中风险。
目前，根据临床研究认为主动脉弓的三个分支血管均需有效过滤栓子， 才能最大程度的降低发生脑卒中的风险。而在主动脉瓣置入术开始之前，需先将脑栓塞保护装置中的血栓过滤器释放后调整至对应三个分支血管的对应位置，同时，使血栓过滤器与主动脉弓的弯曲弧度相贴合，以达到血栓过滤器与三个分支血管口处起到过滤栓子的作用，然后在主动脉瓣置入术开始后的整个过程中需要保持脑栓塞保护系统不动，防止手术中脑栓塞保护装置偏移或偏转造成脑栓塞保护装置不能有效的贴合主动脉弓，使得栓子泄漏流入三个分支血管，造成脑卒中风险。但是由于实际中用于释放血栓过滤器的两个相对运动的手柄之间相互套接，则其中一个手柄内预留供另一手柄相对运动的空间，使得部分鞘芯处于悬空状态，在血栓过滤器的释放过程中，为使手柄之间相对运动施加轴向的推力可能导致鞘芯扭转，而使得鞘芯在自膨物完全自膨后处于非稳定的状态，且该扭转的非稳定状态在血栓过滤器释放后调整至对应三个分支血管的对应位置时仍然不能消除，从而导致血栓过滤器调整贴合至三个分支血管后仍处于非稳定状态，而使主动脉瓣置入术过程中血栓过滤器存在扭转回复导致栓子泄漏，流入三个分支血管，造成脑卒中风险。
发明内容
针对血栓过滤器对主动脉瓣植入术对的重要性需求，提供一种输送器及脑栓塞保护系统。
本申请提供了一种输送器，用于输送自膨物，所述输送器包括手柄组件、鞘芯和鞘管，且所述鞘芯穿设于所述手柄组件和所述鞘管；所述鞘管的近端与所述手柄组件的远端连接，所述手柄组件包括第一手柄和第二手柄，所述鞘芯的近端与所述第二手柄的近端固定连接，所述第一手柄与所述第二手柄相互套接，且所述第一手柄与所述第二手柄可相对滑动，使得所述鞘管相对所述鞘芯沿轴向运动，所述手柄组件还包括围绕所述鞘芯设置的保护结构，且在所述自膨物的自膨胀过程中，所述保护结构的远端收容于所述手柄组件内。
在其中一个实施例中，所述第二手柄套接于所述第一手柄的外侧，所述保护结构设置于所述第二手柄内，所述保护结构包括固定杆或滑杆，所述固定杆或滑杆围绕所述鞘芯设置。
在其中一个实施例中，所述第二手柄包括中空的第二杆体，所述输送器包括未释放自膨物时的初始状态，当所述输送器处于所述初始状态时，所述第二手柄的近端内侧与所述第一手柄的近端之间的距离为L1，定义所述保护结构的长度为L，则所述保护结构的长度L满足：L≥L1。
在其中一个实施例中，所述第一手柄的远端与所述鞘芯之间设置有密封件，所述输送器还包括自膨物完全展开的释放状态，当所述输送器处于所述释放状态时，所述第二手柄的近端内侧与所述密封件近端之间的距离为L2，则所述保护结构L满足：L≤L2。
在其中一个实施例中，所述保护结构相对所述鞘芯为可滑动连接结构，使所述保护结构可沿着所述鞘芯沿轴向相对运动。
在其中一个实施例中，所述保护结构的近端设置有滑钮，所述第二手柄沿轴向设置有滑槽，所述滑钮从所述滑槽露出。
在其中一个实施例中，所述保护结构与所述鞘芯固定。
在其中一个实施例中，所述第一手柄的远端内设有Y型接头，所述Y型接头包括沿轴向的第一通道和沿斜向的第二通道。
在其中一个实施例中，所述第一手柄沿轴向设有导向结构，所述第二手柄对应设置有滑件，所述滑件与所述导向结构相配合，随着所述第二手柄与所述第一手柄相对滑动，所述滑件相对所述导向结构沿轴向滑动。
本申请还提供了一种脑栓塞保护系统，所述脑栓塞保护系统包括血栓过滤器、以及如上述的输送器，所述输送器用于输送所述血栓过滤器。
本申请的一个实施例的一个技术效果是：本申请提供了一种用于脑栓塞保护系统的输送器，在血栓过滤器的释放过程中，可以有效减少因使第一手柄与第二手柄的相对运动施加的轴向推力可能导致的鞘芯扭转，从而降低鞘芯在自膨物完全自膨后处于非稳定状态的可能性，进而减少脑卒中风险。
附图说明
图1为本申请所提供的实施例1的输送器的立体图(初始状态)；
图2为图1的爆炸图(省略鞘芯)；
图3为图1中A-A方向的剖视图(初始状态)；
图4为图3中B处的放大图；
图5为本申请所提供的实施例1中的输送器处于释放状态的剖面图；
图6为本申请所提供的实施例1带保护结构的输送器初始状态的剖面图；
图7为本申请所提供的实施例1中的输送器将血栓过滤器释放后贴合主动脉弓的示意图；
图8为本申请所提供的实施例2的输送器处于初始状态的剖面图；
图9为图8中C处的放大图；
图10为本申请所提供的实施例2的输送器处于释放状态的剖面图；
图11为本申请所提供的实施例3的输送器的立体图(初始状态)；
图12为本申请所提供的实施例3的输送器处于初始状态的剖面图；
图13为本申请所提供的实施例3的输送器处于释放状态的剖面图；
图14为图13中D处的放大图；
图15为本申请所提供的实施例3的输送器的滑钮推至滑槽的远端时的剖视图；
图16图15中E处的放大图。
具体实施方式
为使本申请的上述目的、特征和优点能够更加明显易懂，下面结合附图对本申请的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本申请。但是本申请能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本申请内涵的情况下做类似改进，因此本申请不受下面公开的具体实施的限制。
需要说明的是，当元件被称为“固定于”或“设置于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的，并不表示是唯一的实施方式。
除非另有定义，本文所使用的所有的技术和科学术语与属于本申请的技术领域的技术人员通常理解的含义相同。本文中在本申请的说明书中所使用的术语只是为了描述具体的实施方式的目的，不是旨在于限制本申请。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。
为方便描述，此处限定术语“远端”和“近端”，上述术语为介入医疗器械领域的惯用术语。具体而言，“远端”表示手术过程中远离操作者的一端，“近端”表示手术过程中靠近操作者的一端。轴向”一般是指医疗器械在被输送时的长度方向，“周向”一般是指绕“轴向”的方向，“径向”一般是指医疗器械的与其“轴向”垂直并经过中心轴的方向，并依据此原理定义医疗器械的任一部件的“轴向”和“径向”。
在介入医疗领域，自膨物一般为经热定型加工形成的具有自膨胀性能的弹性体，可以发生径向形变，在输送过程中一般处于径向压缩的状态而收束于鞘管内，在解除径向束缚力时，自膨物因自身的自膨胀性能可以发生弹性形变回至预定型状态。
实施例1
实施例1提供一种输送器100，如图1-7所示，用于脑栓塞保护系统中，将血栓过滤器90植入到血管内以过滤血栓或钙化物等微粒或颗粒，以用于配合瓣膜置换手术为例，输送器用于将血栓过滤器90释放于主动脉弓的位置处并贴合于主动脉弓的三个分支口，以阻挡血流中的血栓或硬块等微粒通过主动脉弓的三个分支中的任一个分支而流入脑部，避免导致脑栓塞的发生，如图7所示。如图1-3结合图7所示，输送器100包括手柄组件10、鞘芯60、 鞘管80和导引头70，其中，鞘芯60自近端至远端依次穿设于手柄组件10和鞘管80内，且导引头70设置于鞘芯60的远端，用于导引输送器100介入人体。
如图1-4结合图7所示，手柄组件10包括第一手柄11和第二手柄12，鞘管80的近端与第一手柄11的远端连接，鞘芯60的近端与第二手柄12的近端固定连接，第一手柄11与第二手柄12相互套接，且第一手柄11与第二手柄12可相对滑动，使得第一手柄11相对第二手柄12沿轴向朝向近端运动时，第一手柄11可带动鞘管80相对鞘芯60沿轴向朝近端运动，从而使得固定于鞘芯60远端的血栓过滤器90在输送器100的远端脱离鞘管80的束缚而释放。如图3-4结合图1-2所示，第一手柄11包括端帽111、接头组件112、围绕接头组件112设置的壳体113、与壳体113近端连接的第一杆体114，端帽111、接头组件112以及第一杆体114沿轴向设有供鞘芯60穿过的通孔，接头组件112的远端与鞘管80的近端通过螺帽115固定连接，接头组件112与鞘芯60之间设置有密封件116。
如图2-4所示，接头组件112的远端带有锥度，为了更好的固定鞘管80，可以在鞘管80的近端开口设置少许锥度，与接头组件112的远端锥度相贴合，同时，接头组件112的远端设有外螺纹，再通过设有内螺纹的螺帽115与设有外螺纹的接头组件112螺纹固定。
在本实施方式中，接头组件112为Y型接头，Y型接头包括沿轴向的第一通道和相对第一通道1121沿斜向的第二通道1123，第一通道1121为鞘芯通道，供鞘芯60穿过，第二通道1123为猪尾导管通道，供猪尾导管造影时穿入并自鞘管的远端穿出，轴向的鞘芯通道与斜向的猪尾导管通道形成Y型，在Y型接头上还设置有排气阀通道1122。第二通道自其与第一通道的连通处朝向近端方向延伸并逐渐远离第一通道，便于猪尾导管沿第二通道伸入第一通道后朝向第一通道的远端伸入。
排气阀通道1122设置在猪尾导管通道的对侧，且沿径向设置，排气阀通道通过导管连接三通阀，排气阀通道的设置方向和设置位置均不做限制，可 以沿径向设置，也可以沿斜向设置，可以设置在Y型接头上，也可以设置在手柄组件的其他位置，只要能实现其排气功能即可。
其中，鞘管80的近端与Y型接头轴向的远端通过螺帽115固定且与Y型接头相连通，使得Y型接头设置在第一手柄的远端，方便猪尾导管沿第二通道穿入第一通道进行造影。Y型接头外侧设有两个相对的半边壳体113，壳体113内设有与Y型接头结合排气阀通道的外形相适配的凹槽，壳体113的远端设有外螺纹，端帽111对应设有内螺纹，两个相对的半边壳体113的远端与端帽111之间通过内外螺纹固定，近端通过锁螺丝固定；排气阀通道1122外接三通阀118；通过Y型接头设置猪尾导管通道，可以利用猪尾导管从Y型接头的猪尾导管通道进入并在主动脉弓处造影，观察血栓过滤器的贴合情况，还可以利用猪尾导管穿过主动脉弓后，到达钙化的主动脉瓣的位置进行造影，使包括该输送器100的脑栓塞保护系统在主动脉瓣置换术中进行脑保护时，无需对造影额外增加入路，可以减少手术时间，降低手术风险。
密封件116的近端一侧设置有锁紧螺母117，密封件116设置于Y型接头的近端与锁紧螺母117之间，鞘芯60分别穿过密封件116与锁紧螺母117的避让孔，通过锁紧螺母117沿轴向对密封件116挤压固定，达到密封效果，以防止漏血，同时不会对鞘芯60与第一手柄11之间产生相对运动时造成太大阻力，即不影响鞘芯60与第一手柄11的相对运动。
第一杆体114包括位于远端的嵌部1141，壳体113近端的内侧对应设有嵌槽1131，嵌槽1131的形状与嵌部1141的形状相匹配，嵌部1141的剖面呈“工”字型，使得第一杆体114相对壳体113在轴向方向上固定，为了防止第一杆体114相对壳体113沿周向转动，可将嵌部1141的中间凹陷处设为六边形结构或其他非圆形结构，当然，也可以在周向上设置限位件，只要最终达到防止第一杆体114相对壳体113沿周向转动的目的即可，从而防止第一杆体114与第二杆体之间沿轴向相对运动时，有周向运动的风险而导致鞘芯扭转。
第一杆体114的杆身上还包括沿轴向延伸的导向结构，用于与第二手柄 相对运动时起导向作用，导向结构可设置为导向槽1142。
第二手柄12套接于第一手柄11的外侧，第二手柄12为套接在第一杆体114外侧的第二杆体，第二杆体为中空杆体，第二杆体设有滑件121，同样地，在其他的实施方式中，也可以设置为第一杆体为中空杆体，将第一杆体套接在第二杆体的外侧，以实现第一手柄与第二手柄的相对滑动即可。在其中一个实施方式中，滑件121为沿径向设置的球头柱塞，第二杆体的远端对应导向槽1142的位置沿径向设有螺纹，球头柱塞沿螺纹锁入第二杆体，同时将球头柱塞的一端嵌入第一杆体114的导向槽1142内，球头柱塞的嵌入端可随着第一杆体114与第二杆体的相对滑动而在导向槽1142内沿轴向滑动，防止第二杆体与第一杆体114沿轴向相对运动的过程中沿周向相对转动，使第二杆体与第一杆体114沿轴向上来回相对运动的过程中，鞘芯60不会沿周向扭转，即实现第二手柄12相对第一手柄11的定向滑动。
第一手柄11相对第二手柄12运动时，导向槽1142的设置使得可以减少鞘芯60沿周向转动，从而实现待自膨物沿特定方向上的平稳释放，进而减少鞘芯60因第一手柄与第二手柄之间相对周向转动所导致的自身扭转，使得瓣膜置换术开始后，脑栓塞保护系统始终处于稳定状态，进一步减少栓子泄漏的可能性，防止脑卒中。
如图7结合图1-5所示，在血栓过滤器90释放完全后，一般需稍微调整血管血栓过滤器90贴合主动脉弓后，再进行瓣膜置换术，而鞘芯60的扭转可能导致鞘芯60在通过调整输送器使得血栓过滤器90实现贴合主动脉弓后仍然处于非稳定状态，而后开始瓣膜置换术的过程中，血栓过滤器90的输送器受到外界环境的因素影响，导致鞘芯60的非稳定状态朝向稳定状态转变，从而导致血管过滤器由瓣膜置换术时与主动脉弓贴合的状态变为非贴合状态，进而导致栓子泄漏进入分支血管，造成脑卒中的风险。
第二手柄12的近端与鞘芯60的近端通过紧固件13固定，使得第二手柄12与第一手柄11沿轴向相对滑动时，鞘管80相对鞘芯60向近端移动，鞘芯60的远端连接有血栓过滤器90，第一手柄11与第二手柄12沿轴向的相 对运动，实现了血栓过滤器90在鞘管80内的释放与回收。如图5所示，输送器还包括紧固件13，紧固件13的远端呈锥型且受挤压可沿径向抱紧，紧固件13内设有供鞘芯60穿入的固定孔，第二手柄12的近端设有与紧固件13远端相适配的锥型孔结构，鞘芯60的近端穿入紧固件13的固定孔内，同时紧固件13的远端嵌入第二手柄12近端的锥型孔，从而实现通过紧固件13将鞘芯60与第二手柄12固定连接。
如图6所示，手柄组件还包括围绕鞘芯60设置的保护结构14，保护结构14用于在第一手柄11与第二手柄12相对运动的过程中，保护鞘芯60，防止在自膨物的释放过程中，因第二手柄12受沿轴向的推力而导致鞘芯扭转，而使鞘芯在自膨物自膨胀后处于非稳定的状态。
第二手柄12内设置的保护结构14为中空的固定杆，固定杆围绕鞘芯60设置，且固定杆的外径小于第一杆体114的内径以便于第二手柄12沿轴向相对第一手柄11运动时，固定杆可以进入第一杆体114中空的轴向孔内，防止固定杆的设置影响第二手柄12相对第一手柄11运动的进程，从而导致影响血栓过滤器90的释放。紧固件13设置于第二手柄12的近端，固定杆围绕鞘芯60且鞘芯60的近端微露出于固定杆的近端，固定杆和鞘芯60的近端均延伸至紧固件13的固定孔内，紧固件13的远端嵌入第二手柄12的近端锥型孔内，紧固固定杆和鞘芯60的近端，从而将固定杆与鞘芯60一起与第二手柄12的近端固定连接在一起。
由于第二手柄12套接于第一手柄11外侧，且第二手柄12与第一手柄11之间需要相对滑动，则中空的第二手柄12内需预留供第一手柄11相对运动的空间，则在第一手柄11与第二手柄12相对运动的过程中，第二手柄12与第一手柄11近端之间的这部分鞘芯60则处于悬空状态，处于悬空状态的这部分鞘芯60定义为悬空段，在第一手柄11与第二手柄12相对运动的推力作用下，由于鞘芯60较细，则悬空段在轴向的推力作用下，有发生周向扭转的风险，鞘芯60的周向扭转容易使得血栓过滤器90在释放后并调整至贴合于主动脉弓时仍处于周向扭转的非稳定状态。将固定杆围绕鞘芯60设置，在第 二手柄12与第一手柄11相对运动过程中，固定杆随鞘芯60一起相对第一手柄11运动，可以降低鞘芯60扭转的风险。
输送器包括未释放自膨物时的初始状态(如图3所示)以及自膨物完全展开的释放状态(如图5所示)，在本实施方式中，当输送器植入到预定位置，处于尚未开始释放自膨物的初始状态时，此时悬空段沿轴向上的长度最大，随着自膨物的逐步释放，悬空段的长度逐渐减小，直至自膨物处于完全展开的释放状态，在自膨物的自膨胀过程中，保护结构的远端始终收容于手柄组件内。
本实施例还提供一种包括上述输送器100的脑栓塞保护系统，脑栓塞保护系统还包括血栓过滤器90，血栓过滤器90具有超弹性和形状记忆特性，固定于鞘芯60的远端，可经压缩装载于上述输送器100的鞘管80内，并在鞘管80和鞘芯60之间的间隔空间内呈压缩状态，以便于借助输送器100将血栓过滤器90输送到体内预定位置后释放展开从而贴合于主动脉弓。当血栓过滤器90在第二手柄12与第一手柄11的相对运动下从鞘管80内伸出后，血栓过滤器90和鞘芯60相对主动脉弓的三个分支血管的位置如图7所示，血栓过滤器90在形状记忆特性的作用下自膨胀展开的展开状态与主动脉弓的形态大体一致，顺应主动脉弓的形状，实现更好的贴合。
在手术之前，输送器100的鞘芯60远端的合适位置处固定有血栓过滤器90，对于血栓过滤器90的近端还是远端固定在鞘芯60上，在此不做限定，只要实现血栓过滤器90固定在鞘芯60的远端，能够随着鞘芯60沿轴向相对鞘管80运动而从鞘管80中释放或回收至鞘管80内即可。
手术时，从人体或动物体的一侧股动脉进行穿刺，之后送入导丝建立体内输送通道；待导丝到达预定位置后，将收容有血栓过滤器90的鞘管80沿导丝通道输送到主动脉弓所在区域，此时，借助DSA(Digital subtraction angiography，数字减影血管造影)设备，根据血栓过滤器90上设置的显影件的位置，判断血栓过滤器90与主动脉弓的三个分支血管的相对位置，且当通过DSA设备观察到血栓过滤器90对应主动脉弓的三个分支血管区域时，保 持第二手柄12不动，后撤第一手柄11带动鞘管80后退，从而将血栓过滤器90从鞘管80内逐步释放，直到整个血栓过滤器90完全从鞘管80的远端露出，自膨胀展开至将主动脉弓的三个分支血管各自的开口覆盖使血栓过滤器90与主动脉弓贴合；之后，利用猪尾导管从Y型接头的猪尾导管通道1123进入并穿过主动脉弓后，到达钙化的主动脉瓣的位置进行造影；在置换过程中，脱落的钙化组织、栓子等颗粒或微粒会随着血流朝主动脉弓的方向移动；由于血栓过滤器90已在主动脉弓的三个分支血管各自的分支血管口处形成了严密的过滤机制，栓子、钙化组织等漂浮物被血栓过滤器90过滤随血流偏向到降主动脉处，从而避免这些漂浮物经过三个分支血管流到脑部；待主动脉瓣膜置换完成后，回撤主动脉置换瓣鞘管80；之后朝远端推送脑栓塞保护系统的鞘管80，以使血栓过滤器90收容在鞘管80的远端内，然后再将血栓过滤器90随着鞘管80一起撤出体外，从而完成手术。
实施例2
实施例2提出另一种输送器200及脑栓塞保护系统，如图8-10所示。实施例2的输送器200与实施例1的输送器100中相同或可以挪用的特征部分在此不再赘述，主要的不同之处在于，实施例2的输送器200中，如图8所示，定义输送器200处于初始状态时，第二手柄22的近端内侧与第一手柄21的近端之间的距离为L1，即L1为悬空段轴向长度的最大值，定义固定杆24的长度为L，则固定杆24的长度L满足：L≥L1。
因鞘芯60较细，若悬空段在径向上无支撑，鞘芯60轴向受推力易导致折弯或者周向扭转，折弯或周向扭转易使鞘芯60处于卷曲或者扭转的非稳定状态，当固定杆24的长度L≥L1时，固定杆24沿着鞘芯60朝远端延伸至第一手柄21的近端处或第一手柄21内，使得在第一手柄21与第二手柄22相对运动的整个过程中，第二手柄22与第一手柄21之间的鞘芯60一直处于固定杆24的保护下，以降低鞘芯60折弯或扭转的风险，同时使血栓过滤器90顺利释放在预定位置，防止鞘芯60因推力导致的周向扭转而在血栓过滤器90释放调整后贴合于主动脉弓时，鞘芯60依然处于非稳定状态，从而防止 瓣膜置换术中的脑栓塞保护系统的不稳定导致栓子泄漏的可能，进而防止脑卒中。
实施例3
实施例3提出另一种输送器300及脑栓塞保护系统。实施例3的输送器300与实施例1的输送器100中相同或可以挪用的特征部分在此不再赘述，主要的不同之处在于，实施例3的输送器300中，如图11-16所示，第二手柄32内设置有滑杆34，且滑杆34相对鞘芯60为可滑动连接结构。滑杆34围绕鞘芯60设置，且滑杆34的近端设置有滑钮35，同时，第二手柄32上沿轴向设置有滑槽322，以使滑钮35通过滑槽322露于第二手柄32外，从而可利用滑钮35带动滑杆34沿滑槽322滑动。
由于第二手柄32套接于第一手柄31外侧，且第二手柄32与第一手柄31之间需要相对滑动，则中空的第二手柄32内需预留供第一手柄31相对运动的空间，则在第一手柄31与第二手柄32相对运动的过程中，第二手柄32与第一手柄31近端之间的这部分鞘芯60则处于悬空状态，处于悬空状态的这部分鞘芯60定义为悬空段，在第一手柄31与第二手柄32相对运动的推力作用下，由于鞘芯60较细且悬空段在径向上无支撑，则悬空段有发生折弯、折断或周向扭转的风险，鞘芯60的折弯或扭转容易使得血栓过滤器90在释放后调整至贴合于主动脉弓时仍处于折弯或周向扭转的非稳定状态。将滑杆34围绕鞘芯60设置，在第二手柄32与第一手柄31相对运动过程中，滑杆34随鞘芯60一起相对第一手柄31运动，可以降低悬空段折弯或扭转的风险。
输送器300包括未释放待自膨物时的初始状态(如图12所示)以及待自膨物完全展开的释放状态(如图13所示)，在本实施方式中，当输送器300植入到达预定位置，处于尚未开始释放待自膨物的初始状态时，此时悬空段沿轴向上的长度最大，随着待自膨物的释放，悬空段的长度逐渐减小，直至待自膨物处于完全展开的释放状态。
如图12所示，定义输送器300处于初始状态时，第二手柄32的近端内侧与第一手柄31的的近端之间的距离为L1，即L1为悬空段轴向长度的最大 值，定义滑杆34的长度为L，则滑杆34的长度L满足：L≥L1。因鞘芯60较细，若悬空段在径向上无支撑，鞘芯60轴向受推力易导致折弯或者周向扭转，折弯或周向扭转易使鞘芯60处于卷曲或者扭转的非稳定状态，当滑杆34的长度L≥L1时，滑杆34沿着鞘芯60朝远端延伸至第一手柄31的近端处或第一手柄31内，使得在第一手柄31与第二手柄32相对运动的整个过程中，处于第二手柄32与第一手柄31之间的鞘芯60均在滑杆34的保护下，以降低鞘芯60折弯或折断的风险，使得血栓过滤器90顺利释放在预定位置。防止鞘芯60因推力导致的折弯或因推力导致的鞘芯60周向扭转而在血栓过滤器90释放调整后贴合于主动脉弓时，鞘芯60依然处于非稳定状态，从而防止瓣膜置换术中的脑栓塞保护系统的不稳定导致栓子泄漏的可能，进而防止脑卒中。
因输送器300通过第一手柄31与第二手柄32沿轴向相对运动，从而将连接在鞘芯60远端的血栓过滤器90露出鞘管80外，在此过程中，由于脑栓塞保护装置的鞘芯60较细而有少许柔软度，使得第一手柄31与第二手柄32之间的相对运动沿轴向方向的推力会使鞘芯60发生弯曲或者自身周向扭转，且由于鞘芯60在手柄和鞘管80内部，鞘芯60在推力作用下的自身扭转在主动脉瓣植入术开始前，对血栓过滤器90的位置调整往往无法使其回复，在主动脉瓣植入术开始之后，如果鞘芯60因上述推力作用导致的弯曲部分或自身周向扭转在受到外界环境的因素导致鞘芯60发生自动回转(即鞘芯60由非稳定状态朝向稳定状态转变)，将会导致血管过滤器由瓣膜置换术术前与主动脉弓贴合的状态变为非贴合状态，从而导致血栓过滤器90偏移或偏转，进而导致栓子泄漏进入分支血管，造成脑卒中的风险。
当输送器300处于待自膨物完全展开的释放状态时，如图13结合图10所示，定义第二手柄32的近端内侧与密封件316近端之间的距离为L2，则滑杆34的长度L满足：L≤L2。在本实施方式中，由于第一手柄31的第一杆体314与第二手柄32的第二杆体之间为套接，则两杆体之间必然有重叠部分，且第一手柄31的第一杆体314与Y型接头外侧的壳体313之间有重叠部分 (例如嵌部)，除此之外，密封件316与第一杆体314的最远端之间有间距，则L2必然大于L1，当滑杆34的长度满足：L1≤L≤L2时，待自膨物(血栓过滤器90)自初始状态至释放状态的过程中，一方面，悬空段的鞘芯60始终在滑杆34的保护下，可以降低鞘芯60折弯或周向扭转的风险；另一方面，滑杆34处于待自膨物完全展开的释放状态时，滑杆34的远端尚未触及或刚刚触及密封件316，即密封件316不会对待自膨物的整个释放过程产生额外的阻力，使得血栓过滤器90的整个释放过程处于平稳释放的状态，降低手术风险。
滑杆34相对鞘芯60设置为可滑动连接结构，当输送器300处于待自膨物完全展开的释放状态时，可继续通过滑钮35前推带动滑杆34继续朝向远端运动，滑槽322自第二手柄32的近端延伸至第二手柄32的远端，如图13-16结合图11所示，且滑槽322的近端为闭口设置。滑杆34随着滑钮35沿着鞘芯60朝远端推动，直至滑钮35自滑槽322的近端推至滑槽322的远端(此时，输送器的鞘芯处于顺直状态)，滑杆34的远端进入鞘管80内，有利于利用滑杆34捋直鞘芯60，使得鞘芯60因推力作用导致的弯曲部分或自身扭转回转至顺直状态。利用滑钮35前推带动滑杆34沿轴向滑动使得鞘芯60回复至顺直状态后，调整血栓过滤器90与主动脉弓处于贴合状态后，再开始进行主动脉瓣置入术，可以防止因鞘芯60在主动脉瓣置入术中自动回转导致的血栓过滤器90偏移或偏转问题，以确保血栓过滤器90在主动脉植入术中保持稳定，从而减少栓子泄漏风险。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本申请的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本申请构思的前提下，还可以做出若干变形和改进，这些都属于本申请的保护范围。因此，本申请专利的保护范围 应以所附权利要求为准。

Claims (14)

  1. 一种输送器，用于输送自膨物，其特征在于，所述输送器包括手柄组件、鞘芯和鞘管，且所述鞘芯穿设于所述手柄组件和所述鞘管；所述鞘管的近端与所述手柄组件的远端连接，所述手柄组件包括第一手柄和第二手柄，所述鞘芯的近端与所述第二手柄的近端固定连接，所述第一手柄与所述第二手柄相互套接，且所述第一手柄与所述第二手柄可相对滑动，使得所述鞘管相对所述鞘芯沿轴向运动，所述手柄组件还包括围绕所述鞘芯设置的保护结构，且在所述自膨物的自膨胀过程中，所述保护结构的远端收容于所述手柄组件内。
  2. 根据权利要求1所述的输送器，其特征在于，所述第二手柄套接于所述第一手柄的外侧，所述保护结构设置于所述第二手柄内，所述保护结构包括固定杆或滑杆，所述固定杆或滑杆围绕所述鞘芯设置。
  3. 根据权利要求2所述的输送器，其特征在于，所述第二手柄包括中空的第二杆体，所述输送器包括未释放自膨物时的初始状态，当所述输送器处于所述初始状态时，所述第二手柄的近端内侧与所述第一手柄的近端之间的距离为L1，定义所述保护结构的长度为L，则所述保护结构的长度L满足：L≥L1。
  4. 根据权利要求3所述的输送器，其特征在于，所述第一手柄的远端与所述鞘芯之间设置有密封件，所述输送器还包括自膨物完全展开的释放状态，当所述输送器处于所述释放状态时，所述第二手柄的近端内侧与所述密封件近端之间的距离为L2，则所述保护结构L满足：L≤L2。
  5. 根据权利要求1所述的输送器，其特征在于，所述保护结构相对所述鞘芯为可滑动连接结构，使所述保护结构可沿着所述鞘芯沿轴向相对运动。
  6. 根据权利要求5所述的输送器，其特征在于，所述保护结构的近端设置有滑钮，所述第二手柄沿轴向设置有滑槽，所述滑钮从所述滑槽露出。
  7. 根据权利要求1所述的输送器，其特征在于，所述保护结构与所述鞘芯固定。
  8. 根据权利要求7所述的输送器，其特征在于，所述输送器还包括紧固件，所述紧固件设置于所述手柄组件的近端，并将所述保护结构与所述鞘芯固定。
  9. 根据权利要求1所述的输送器，其特征在于，所述第一手柄内设有Y型接头，所述Y型接头包括沿轴向的第一通道和沿斜向的第二通道。
  10. 根据权利要求9所述的输送器，其特征在于，所述第二通道自其与所述第一通道的连通处朝向近端方向延伸并逐渐远离所述第一通道。
  11. 根据权利要求9所述的输送器，其特征在于，所述Y型接头设置于所述第一手柄的远端。
  12. 根据权利要求1所述的输送器，其特征在于，所述保护结构的外径小于所述第一手柄的内径以便于所述第一手柄与所述第二手柄可相对滑动。
  13. 根据权利要求1所述的输送器，其特征在于，所述第一手柄沿轴向设有导向结构，所述第二手柄对应设置有滑件，所述滑件与所述导向结构相配合，随着所述第二手柄与所述第一手柄相对滑动，所述滑件相对所述导向结构沿轴向滑动。
  14. 一种脑栓塞保护系统，包括血栓过滤器、以及如权利要求1-13任意一项所述的输送器，所述输送器用于输送所述血栓过滤器。
PCT/CN2023/130272 2022-11-07 2023-11-07 输送器及脑栓塞保护系统 WO2024099325A1 (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202211382846.7 2022-11-07
CN202211382846.7A CN117982196A (zh) 2022-11-07 2022-11-07 输送器及脑栓塞保护系统

Publications (1)

Publication Number Publication Date
WO2024099325A1 true WO2024099325A1 (zh) 2024-05-16

Family

ID=90889896

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2023/130272 WO2024099325A1 (zh) 2022-11-07 2023-11-07 输送器及脑栓塞保护系统

Country Status (2)

Country Link
CN (1) CN117982196A (zh)
WO (1) WO2024099325A1 (zh)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102004003326A1 (de) * 2003-01-24 2004-08-12 Medtronic Vascular, Inc., Santa Rosa Führungsdrahtvorrichtung für temporäre, distale Embolieprotektion
CN103431926A (zh) * 2013-09-04 2013-12-11 杭州启明医疗器械有限公司 用于介入器械输送的鞘芯及具有该鞘芯的输送系统
CN207071112U (zh) * 2016-12-29 2018-03-06 先健科技(深圳)有限公司 输送系统
CN109953843A (zh) * 2017-12-26 2019-07-02 杭州唯强医疗科技有限公司 主动脉支架的输送释放装置
CN110292464A (zh) * 2018-03-22 2019-10-01 杭州启明医疗器械股份有限公司 可调弯介入瓣膜输送系统
CN219423047U (zh) * 2022-11-07 2023-07-28 先健科技(深圳)有限公司 输送器及脑保护系统

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102004003326A1 (de) * 2003-01-24 2004-08-12 Medtronic Vascular, Inc., Santa Rosa Führungsdrahtvorrichtung für temporäre, distale Embolieprotektion
CN103431926A (zh) * 2013-09-04 2013-12-11 杭州启明医疗器械有限公司 用于介入器械输送的鞘芯及具有该鞘芯的输送系统
CN207071112U (zh) * 2016-12-29 2018-03-06 先健科技(深圳)有限公司 输送系统
CN109953843A (zh) * 2017-12-26 2019-07-02 杭州唯强医疗科技有限公司 主动脉支架的输送释放装置
CN110292464A (zh) * 2018-03-22 2019-10-01 杭州启明医疗器械股份有限公司 可调弯介入瓣膜输送系统
CN219423047U (zh) * 2022-11-07 2023-07-28 先健科技(深圳)有限公司 输送器及脑保护系统

Also Published As

Publication number Publication date
CN117982196A (zh) 2024-05-07

Similar Documents

Publication Publication Date Title
US10939915B2 (en) Aneurysm device and delivery system
US11510769B2 (en) Embolic protection devices and methods of use
JP7434392B2 (ja) ステントグラフトを半径方向に収縮するための送達システム
JP6553761B2 (ja) 人工器官のための反転送達デバイスおよび方法
JP5980200B2 (ja) 患者の体内に拡張型心臓弁ステントを導入するカテーテルシステム、カテーテルシステムを有する挿入システム、および心臓弁異常を治療する医療器具
US9510947B2 (en) Catheter system for introducing an expandable heart valve stent into the body of a patient
US20190247213A1 (en) Stent Graft Delivery System with Constricted Sheath and Method of Use
WO2018103662A1 (zh) 植入物的输送系统
US9980803B2 (en) Medical device retrieval system and method
JP5109195B2 (ja) 体内埋入物解放機構
US10426613B2 (en) Delivery catheter and catheter arrangement
KR20190134541A (ko) 동맥류 디바이스 및 전달 시스템
US9237960B2 (en) Apparatus for curving an implantable medical device in a lumen
US20100191272A1 (en) Distal access embolic protection system and methods of using the same
KR20130076813A (ko) 색전 물질 절개 트랩핑 장치
JP2012050841A (ja) ステントグラフトの近位端部を自動的に中心に配置する送達システム及び方法
JP2019530512A (ja) 血栓凝血塊の液圧変位および除去、ならびに液圧変位を実施するためのカテーテル
KR20210158349A (ko) 가요성 붕괴가능한 프레임을 갖는 혈전 회수 장치
WO2017002155A1 (ja) 塞栓捕捉装置
JP7367150B2 (ja) オクルーダ挿入システム
US11771556B2 (en) Intervention guidance device
CN219423047U (zh) 输送器及脑保护系统
WO2024099325A1 (zh) 输送器及脑栓塞保护系统
US20100191273A1 (en) Embolic protection device with no delivery catheter or retrieval catheter and methods of using the same
EP3718492A1 (en) Apparatus for neurovascular endoluminal intervention

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 23888014

Country of ref document: EP

Kind code of ref document: A1