WO2024125147A1 - Appareil de thérapie d'intervention intravasculaire - Google Patents

Appareil de thérapie d'intervention intravasculaire Download PDF

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Publication number
WO2024125147A1
WO2024125147A1 PCT/CN2023/129273 CN2023129273W WO2024125147A1 WO 2024125147 A1 WO2024125147 A1 WO 2024125147A1 CN 2023129273 W CN2023129273 W CN 2023129273W WO 2024125147 A1 WO2024125147 A1 WO 2024125147A1
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WIPO (PCT)
Prior art keywords
grid body
treatment device
interventional treatment
proximal
intravascular interventional
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PCT/CN2023/129273
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English (en)
Chinese (zh)
Inventor
郭爽
常孟琪
郭远益
张园园
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微创神通医疗科技（上海）有限公司
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Publication of WO2024125147A1 publication Critical patent/WO2024125147A1/fr

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  • the present invention relates to the technical field of medical devices, and in particular to an intravascular interventional treatment device for aneurysm packing.
  • Intracranial aneurysm is a common cerebrovascular disease in clinical practice, with a high mortality and disability rate.
  • a non-invasive imaging study showed that the prevalence of intracranial aneurysms in Chinese was 7%.
  • the mortality rate of subarachnoid hemorrhage caused by rupture of intracranial aneurysms is as high as 45% within 30 days, and about 30% of the survivors have varying degrees of neurological deficits.
  • Large and giant aneurysms can also cause intracranial mass effect, compressing brain tissue and cranial nerves and leading to corresponding clinical symptoms.
  • the traditional treatment for intracranial aneurysms is craniotomy and clipping, while endovascular treatment has developed rapidly in the past 20 years due to its minimally invasive characteristics.
  • ISAT International Subarachnoid Aneurysm Trial
  • endovascular treatment was superior to surgical clipping in terms of residual mortality and epilepsy incidence, and endovascular treatment has become the preferred treatment for more and more intracranial aneurysms.
  • interventional treatment products on the market include coils and stents for auxiliary coil embolization, covered stents, blood flow guidance devices, and aneurysm cavity embolization devices.
  • Coil embolization relies on preformed coils to be released from the catheter into the aneurysm for filling, causing the blood flow in the aneurysm cavity to slow down and stagnate, thereby causing the formation of clots and excluding further blood inflow, thereby preventing further expansion of the aneurysm.
  • additional devices need to be implanted during coil embolization to avoid coil herniation, such as auxiliary stents or blood flow guidance devices.
  • the use of multiple devices increases the operation time, treatment costs, and the possibility of adverse events. Covered stents and blood flow diversion devices are used to treat aneurysms through vascular reconstruction.
  • the WEB device is mainly suitable for treating wide-diameter aneurysms at bifurcations, and is particularly suitable for regular aneurysms.
  • the device has a long release length, and the distal rivet point has an impact on the aneurysm wall.
  • the single spherical or cylindrical structure has a limited degree of fit with the inner wall of the aneurysm, and is easily squeezed and displaced after long-term implantation.
  • the working principle of the Artisse device is basically similar to that of the WEB device.
  • the Contour device is disc-shaped and is suitable for bifurcated or apical aneurysms. The position of the device needs to be repeatedly adjusted to allow the device to completely cover the aneurysm neck, otherwise it will affect the stability of the device in the aneurysm.
  • the object of the present invention is to provide an intravascular interventional treatment device to solve at least one technical problem existing in the intravascular treatment of aneurysms in the prior art.
  • the present invention provides an intravascular interventional treatment device having an expanded state and a compressed state, and comprising a grid body and a fixing mechanism; at least part of the fixing mechanism is placed in the In the grid body, one end of the fixing mechanism is connected to the distal end of the grid body; in the expanded state, the fixing mechanism can be forced to move to drive the distal end of the grid body to move along the axial direction of the grid body, thereby adjusting the axial height of the grid body, and the fixing mechanism after movement can also be locked with the proximal end of the grid body to limit the axial height of the grid body, and enable the intravascular interventional treatment device to fill only part of the space of the target cavity to avoid the top of the target cavity and cover the neck of the target cavity at the same time.
  • the fixing mechanism includes a traction member and a locking member; at least a portion of the traction member is placed in the grid body via the proximal end of the grid body, and one end of the traction member is connected to the distal end of the grid body; the locking member is connected to the traction member and placed in the grid body; in the expanded state, when the traction member and/or the locking member is moved under force, the fixing mechanism drives the distal end of the grid body to move axially through the traction member until the moving locking member is locked with the proximal end of the grid body.
  • the distal portion of the traction member is placed in the grid body via the proximal end of the grid body, and one end of the traction member is connected to the distal end of the grid body; the proximal portion of the traction member extends from the proximal end of the grid body so that the other end of the traction member is exposed outside the grid body; a release zone is provided on the proximal side of the locking member; after the fixing member is locked with the proximal end of the grid body, the release zone is used to control the release between the proximal portion and the distal portion.
  • the intravascular interventional treatment device also includes a proximal fixing member and a distal fixing member, the proximal end of the grid body is constrained and fixed by the proximal fixing member, the distal end of the grid body is constrained and fixed by the distal fixing member, one end of the traction member is connected to the distal fixing member, and the locking member is used to lock with the proximal fixing member.
  • the locking member in the expanded state, has an initial position and a locking position; in the initial position, the locking member is separated from the proximal fixing member; in the locking position, the locking member is locked with the proximal fixing member; wherein the axial distance between the initial position and the distal fixing member is less than the axial height of the grid body.
  • an axial distance between the initial position and the distal fixing member is 0.4 to 0.6 times the axial height of the grid body.
  • the axial height of the grid body is not greater than the radial maximum diameter of the grid body.
  • the maximum radial diameter of the grid body is 3 mm to 25 mm.
  • the outer contour of the grid body is in the shape of an oblate spheroid, a cylinder or a truncated cone.
  • the diameter of the outer top surface of the grid body is 1.5 to 3 times the diameter of the outer bottom surface.
  • the grid body is made of biodegradable material.
  • the biodegradable material for preparing the grid body is one or more combinations of the following materials: polydioxanone, lactide- ⁇ -caprolactone copolymer, polylactic acid, polylactic acid-glycolic acid copolymer and mixtures thereof.
  • the grid body is a braided structure
  • the diameter of the braided wires in the braided structure is 0.001 in to 0.003 in
  • the number of the braided wires is 48 to 144.
  • the present invention also provides a method for deploying any one of the intravascular interventional treatment devices, comprising:
  • the intravascular interventional treatment device After the intravascular interventional treatment device is completely pushed out of the microcatheter, the intravascular interventional treatment device is deformed from a free expansion state to a filling state placed in the aneurysm;
  • the microcatheter and the push rod are kept stationary, and then force is applied to the fixing mechanism, so that the fixing mechanism controls the distal end of the grid body to move along the axial direction of the grid body until the fixing mechanism is locked with the proximal end of the grid body;
  • the intravascular interventional treatment device can be stably fixed at the tumor neck.
  • the above intravascular interventional treatment device has an expanded state and a compressed state, and is characterized in that it includes a grid body and a fixing mechanism; at least a portion of the fixing mechanism is placed in the grid body, and one end of the fixing mechanism is connected to the distal end of the grid body; in the expanded state, the fixing mechanism can be forced to move to drive the distal end of the grid body to move along the axial direction of the grid body, thereby adjusting the axial height of the grid body, and the fixing mechanism after movement can be locked with the proximal end of the grid body to limit the axial height of the grid body, and enable the intravascular interventional treatment device to only fill part of the space of the target cavity to avoid the top of the target cavity and cover the neck of the target cavity at the same time.
  • the intravascular interventional treatment device when the intravascular interventional treatment device is filled in the aneurysm in the expanded state, it only fills the lower part of the aneurysm cavity, and avoids the upper part of the aneurysm top during the filling process, which can reduce the impact on the easily ruptured aneurysm top and reduce the space-occupying effect of large aneurysms.
  • the axial height of the intravascular interventional treatment device can be adjusted, and the radial shape of the intravascular interventional treatment device can also be adjusted, so that the intravascular interventional treatment device can be stably filled in the neck of the aneurysm, ensuring the long-term effectiveness of the intravascular interventional treatment device in treating aneurysms.
  • the fit between the grid body and the aneurysm wall is better, and the aneurysm neck is covered more completely.
  • the impact of blood on the aneurysm cavity can be reduced by the turbulence effect of the dense mesh of the grid body.
  • the intravascular interventional treatment device since the intravascular interventional treatment device only needs to consider the coverage of the aneurysm neck, it does not need to fully adapt to the shape of the aneurysm and can be used for filling different aneurysms, thereby expanding the scope of application of the intravascular interventional treatment device.
  • the axial height of the grid body is less than the maximum radial diameter of the grid body.
  • the axial height of the grid body is small, which shortens the release length of the intravascular interventional treatment device, reduces the difficulty of operation for doctors, and reduces the impact on the easily ruptured tumor top, thereby reducing the risk of rupture during the perioperative period.
  • the grid body is made of degradable materials, which can be degraded and absorbed by the human body after the tumor neck is endothelialized, thereby reducing the presence of foreign matter in the human body and further reducing the space-occupying effect.
  • the fixing mechanism can also help the degradable grid body return to the initial expansion state, thereby improving the shape recovery of the degradable grid body, ensuring its wall adhesion and support performance, and after the tumor neck is healed, the grid body is gradually degraded to reduce the occurrence of space-occupying effect.
  • FIG1 is a schematic diagram of the front view of the structure of the intravascular interventional treatment device in the deployed state according to the first embodiment of the present invention
  • FIG2 is a schematic diagram of the top view of the structure of the intravascular interventional treatment device in the deployed state according to the first embodiment of the present invention
  • FIG3 is a schematic diagram of a scene in which an intravascular interventional treatment device is pushed out from a microcatheter and released into an aneurysm according to Embodiment 1 of the present invention
  • FIG4a is a schematic diagram of a scene when the intravascular interventional treatment device according to the first embodiment of the present invention is deformed from a free expansion state to a filling state in an aneurysm, wherein a double-headed arrow H indicates a height direction;
  • FIG4 b is a one-way locking method of the first embodiment of the present invention, wherein the one-way buckle is a dovetail-shaped buckle;
  • FIG. 4c and FIG. 4d are another one-way locking method of the first embodiment of the present invention, wherein the one-way buckle is a single-sided locking buckle;
  • FIG. 4e and FIG. 4f are another one-way locking method of the first embodiment of the present invention, wherein the one-way buckle is a conical lock buckle;
  • FIG5 is a schematic diagram of the front view of the structure of the intravascular interventional treatment device according to the second embodiment of the present invention.
  • FIG6 is a schematic diagram of a scene in which an intravascular interventional treatment device according to Embodiment 2 of the present invention is pushed out from a microcatheter and released into an aneurysm;
  • FIG. 7 is a schematic diagram of a scene when the intravascular interventional treatment device according to the second embodiment of the present invention is transformed from a free expansion state to a state of filling inside an aneurysm;
  • FIG8 is a schematic diagram of the front view of the structure of the intravascular interventional treatment device in the expanded state according to the third embodiment of the present invention.
  • FIG9 is a schematic diagram of a scene in which an intravascular interventional treatment device according to Embodiment 3 of the present invention is pushed out from a microcatheter and released into an aneurysm;
  • FIG. 10 is a schematic diagram of a scene when the intravascular interventional treatment device according to the third embodiment of the present invention is deformed from a free expansion state to a filling state within an aneurysm.
  • proximal and distal refer to the relative orientation, relative position, and direction of components or actions relative to each other from the perspective of a doctor using the intravascular interventional treatment device.
  • proximal and distal are not restrictive, “proximal” generally refers to the end of the intravascular interventional treatment device that is close to the doctor during normal operation, and “distal” generally refers to the end that first enters the patient's body.
  • the corresponding "proximal side” generally refers to the surface of the side corresponding to the "proximal end”, and the “distal side” generally refers to the surface of the side corresponding to the “distal end”.
  • distal and proximal in the present application document do not refer to the ends of the structure, but to relative positions.
  • the distal end of the grid body is not the end of the grid body, but a position relatively close to the end of the grid body.
  • the "axial" direction of the intravascular interventional treatment device generally refers to the height direction between the aneurysm neck and the aneurysm top when the device is inserted into the aneurysm;
  • the "radial” direction of the intravascular interventional treatment device generally refers to the diameter direction along the aneurysm neck when the device is inserted into the aneurysm.
  • the "deployed state” of the intravascular interventional treatment device includes the “free expansion state” when there is no external force, and the “filled state” when it is constrained by the aneurysm wall when filled in the aneurysm;
  • the "radial maximum diameter” refers to the maximum diameter of the projection surface of the intravascular interventional treatment device projected onto the plane along the diameter direction.
  • the core idea of the present application is to provide an intravascular interventional treatment device, including but not limited to Regarding the packing of intracranial aneurysms, the specific embodiments may refer to FIGS. 1 to 10 .
  • the intravascular interventional treatment device 10 As shown in FIGS. 1 to 3, 4a to 4f, and 5 to 10, the intravascular interventional treatment device 10 provided in the embodiment of the present application has an expanded state and a compressed state, and can be switched between the expanded state and the compressed state.
  • the intravascular interventional treatment device 10 can be delivered through a microcatheter, and its form in the microcatheter is a compressed state, and it returns to a free expansion state after being pushed out of the microcatheter.
  • the intravascular interventional treatment device 10 can further be deformed from the free expansion state to a tamponade state when tamponade in an aneurysm.
  • the intravascular interventional treatment device 10 provided in the embodiment of the present application includes a grid body 11 and a fixing mechanism 12.
  • the grid body 11 is a three-dimensional grid body, mainly a cage-like structure. At least part of the fixing mechanism 12 is placed in the grid body 11, and one end of the fixing mechanism 12 is connected to the distal end of the grid body 11.
  • a portion of the fixing mechanism 12 is placed in the grid body 11 via the proximal end of the grid body 11, and one end of the fixing mechanism 12 is connected to the distal end of the grid body 11, and the other portion of the fixing mechanism 12 extends from the proximal end of the grid body 11, so that the other end of the fixing mechanism 12 is exposed outside the grid body 11.
  • force can be directly applied to the other end of the fixing mechanism 12 exposed to the outside, so that the movement of the fixing mechanism 12 can be controlled, and there is no need to configure an additional external structure to control the fixing mechanism 12, thereby making the structure simpler and the surgical operation more convenient.
  • the intravascular interventional treatment device 10 when the intravascular interventional treatment device 10 is filling the aneurysm 20, by controlling the fixing mechanism 12 so that the fixing mechanism 12 is forced to move, the distal end of the grid body 11 can be driven by the fixing mechanism 12 to move along the axial direction of the grid body 11, thereby adjusting the axial height of the grid body 11, and the fixed mechanism 12 after movement is locked with the proximal end of the grid body 11, thereby limiting the axial height of the grid body 11, so that the grid body 11 remains in the current shape, as shown in Figures 4a, 7 and 10 for details.
  • the distal end of the grid body 11 can be urged to move toward the grid body.
  • the proximal end of the mesh body 11 moves to adjust the axial distance between the proximal end and the distal end of the mesh body 11.
  • the mesh body 11 can be better fitted with the aneurysm wall, the fit is tighter, and the mesh body 11 can better cover the aneurysm neck 22, and at the same time, the mesh body 11 and the aneurysm wall can be formed into an interference state, so that the intravascular interventional treatment device 10 can be stably filled in the aneurysm neck through the force between the mesh body 11 and the aneurysm wall, ensuring the long-term effectiveness of the intravascular interventional treatment device 10 in treating aneurysms.
  • the filling shape of the mesh body 11 can be conveniently adjusted, so that the intravascular interventional treatment device 10 can be adapted to various aneurysms.
  • the intravascular interventional treatment device 10 provided in the embodiment of the present application is stably fixed in the tumor cavity mainly through the interaction between itself and the tumor wall, and effectively covers the tumor neck 22.
  • the interaction between the tumor wall and the intravascular interventional treatment device 10 refers to the interference fit between the two and the friction between the two.
  • the interference fit can be understood as that, in the unfolded state, the radial maximum diameter of the grid body 11 is larger than the diameter at the corresponding position of the tumor cavity, so that the intravascular interventional treatment device 10 is anchored on the tumor wall by its own expansion force.
  • the diameter at the corresponding position of the tumor cavity can be the maximum diameter of the tumor cavity or a smaller diameter at a certain position.
  • the intravascular interventional treatment device 10 since the intravascular interventional treatment device 10 only needs to consider the coverage of the neck of the aneurysm and does not need to fully adapt to the shape of the aneurysm, it can be applied to different aneurysms, expanding the applicable scope of the intravascular interventional treatment device 10.
  • the turbulence effect of the dense mesh can also reduce the impact of blood flow on the aneurysm cavity, reduce the risk of aneurysm rupture, and provide a climbable scaffold for the repair of the aneurysm neck, which is conducive to the endothelialization of the aneurysm neck.
  • dense mesh generally refers to a mesh body 11 with a material blank rate not exceeding 80%, that is, a mesh body 11 with a material coverage rate not less than 20%.
  • the mesh body 11 is preferably made of biodegradable materials, so that after the tumor neck is endothelialized, the mesh body 11 can be degraded and absorbed by the human body, reducing the presence of foreign matter in the human body and further reducing the possibility of space-occupying effect.
  • the mesh body 11 is non-degradable, which is also within the scope of protection of this application.
  • the biodegradable material for preparing the grid body 11 can be various suitable biodegradable materials.
  • the biodegradable material for preparing the grid body 11 should be selected from materials with a long degradation cycle to avoid the grid body 11 completely losing its mechanical properties before the tumor neck completes endothelialization.
  • the biodegradable material for preparing the grid body 11 is selected from polydioxanone (PDO), lactide- ⁇ -caprolactone copolymer (PLC), polylactic acid (PLA), polylactic acid-glycolic acid copolymer (PLGA) and mixtures thereof, and the biodegradable material for preparing the grid body 11 can be prepared by combining one or more biodegradable materials.
  • PDO polydioxanone
  • PLA lactide- ⁇ -caprolactone copolymer
  • PLA polylactic acid
  • PLGA polylactic acid-glycolic acid copolymer
  • the biodegradable material for preparing the grid body 11 can be prepared by combining one or more
  • the mesh body 11 When the mesh body 11 is degradable, given that the shape recovery ability and mechanical strength of degradable polymer materials are lower than those of metal materials (such as nickel-titanium alloys), it is generally difficult for the mesh body 11 to return to its initial expansion state after being transported through a microcatheter or the like. To this end, the role of the fixing mechanism 12 is also to help the degradable mesh body 11 return to its initial expansion state, thereby improving the shape recovery of the degradable mesh body 11 and ensuring its wall adhesion and support performance. After the tumor neck heals, the mesh body 11 is gradually degraded to reduce the occurrence of space-occupying effect.
  • the mesh body 11 is mainly a braided structure, which is woven by intersecting multiple braided wires.
  • the braided mesh body 11 has good flexibility. There can be a variety of braiding methods, and all braided wires converge at the proximal end of the mesh body 11 to form a proximal convergence point, and converge at the distal end to form a distal convergence point. All braided wires form a braided mesh surface of the entire mesh body between the proximal and distal ends of the mesh body 11.
  • the woven mesh surface of the grid body 11 can be understood according to the filling situation in the aneurysm 20, and specifically may include an outer side surface 111, an outer top surface 112 and an outer bottom surface 113, the outer side surface 111 is arranged between the outer top surface 112 and the outer bottom surface 113, the outer top surface 112 and the outer bottom surface 113 are respectively adjacent to the outer side surface 111, the outer top surface 112 is opposite to the tumor top 21, the outer bottom surface 113 covers the tumor neck 22, the outer side surface 111 is at least partially attached to the tumor wall on both sides of the radial direction of the tumor neck 22, and the outer top surface 112 is away from the tumor top 21 so that a non-filling area is formed between the tumor top 21 and the outer top surface 112.
  • the intravascular interventional treatment device 10 provided in the embodiment of the present application should have good flexibility and support.
  • the wire diameter of the braided wire in the mesh body 11 is set to 0.001in ⁇ 0.003in, and the number of braided wires is set to 48 ⁇ 144.
  • the distal convergence point is usually provided with a distal fixing member 13, and the proximal convergence point is usually provided with a proximal fixing member 14.
  • the proximal fixing member 14 constrains and fixes the braided wire head at the proximal end of the mesh body 11, and the distal fixing member 13 constrains and fixes the braided wire head at the distal end of the mesh body 11.
  • one end of the fixing mechanism 12 is connected to the distal fixing member 13, and the fixing mechanism 12 is locked with the proximal fixing member 14 after movement.
  • the proximal fixing member 14 and the push rod 30 are detachably connected, and the two can be connected in various detachable ways, such as mechanical release, electrical release or other suitable release methods.
  • the proximal fixing member 14 and the push rod 30 only abut against each other, and the two are not connected. Regardless of whether the push rod 30 is connected or abutted against the proximal fixing member 14, the push rod 30 can push the intravascular interventional treatment device 10 to move axially along the microcatheter in the microcatheter.
  • the recovery of the intravascular interventional treatment device 10 can also be controlled by the fixing mechanism 12 to readjust the position of the intravascular interventional treatment device 10.
  • the fixing mechanism 12 includes a locking member 121 and a pulling member 122. At least part of the pulling member 122 is placed in the grid body 11 via the proximal end of the grid body 11, and the pulling member 122 is One end of the guide 122 is connected to the distal end of the grid body 11.
  • the locking member 121 is connected to the traction member 122 and is placed in the grid body 11. In the unfolded state, when at least one of the traction member 122 and the locking member 121 is forced to move, the fixing mechanism 12 can drive the distal end of the grid body 11 to move axially through the traction member 122 until the locking member 121 is locked with the proximal end of the grid body 11.
  • the traction member 122 is generally a relatively soft linear body such as a wire, thread, rope, or belt.
  • the locking member 121 can be various mechanical structures that can achieve one-way locking, including but not limited to the use of a one-way buckle 123, which is not limited in the present application.
  • the distal portion of the traction member 122 located between the distal end of the grid body 11 and the locking member 121 should be in a straight state.
  • the distal end of the traction member 122 is placed in the grid body 11 via the proximal end of the grid body 11, and one end of the traction member 122 is connected to the distal end of the grid body 11, preferably one end of the traction member 122 is connected to the distal fixing member 13; the proximal end of the traction member 122 extends from the proximal end of the grid body 11, so that the other end of the traction member 122 is exposed outside the grid body 11. At this time, the operator only needs to control the other end of the traction member 122 to control the movement of the entire fixing mechanism 12.
  • the proximal end of the traction member 122 also needs to pass through the inner cavity of the push rod 30, so that the other end of the traction member 122 extends to the proximal end of the push rod 30, such as being connected to the push handle on the proximal end of the push rod 30.
  • the locking member 121 is used to lock with the proximal fixing member 14.
  • the traction piece 122 can be divided into a proximal part and a distal part. The distal part is located on the distal side of the locking piece 121, and the proximal part is located on the proximal side of the locking piece 121. When the locking piece 121 is locked with the proximal end of the grid body 11, the distal part is located inside the grid body 11, and the proximal part is located outside the grid body 11.
  • a release zone is provided on the proximal side of the locking member 121, and the release between the proximal portion and the distal portion of the traction member 122 is controlled by the release zone, and the proximal portion and the distal portion are preferably electrically released, so that the proximal portion of the traction member 122 outside the grid body 11 is separated from the distal portion inside the grid body 11. After the two parts of the traction member 122 are separated, the proximal portion of the traction member 122 outside the grid body 11 can be pulled out of the human body.
  • the locking member 121 may have an initial position and a locked position; in the initial position, the locking member 121 is separated from the proximal fixing member 14; in the locked position, the locking member 121 is separated from the proximal fixing member 14
  • the initial position should be understood as the position of the locking member 121 before the fixing mechanism 12 moves.
  • the axial distance between the initial position and the distal fixing member 13 should be less than the axial height of the grid body 11 (the axial height before the fixing mechanism 12 moves), but the axial distance between the initial position and the distal fixing member 13 is not zero, so as to avoid setting the locking member 121 at the distal end of the grid body 11.
  • the axial height of the grid body 11 cannot be much smaller than the radial maximum diameter, otherwise it will affect the support. For this reason, the axial distance between the initial position and the distal fixing member 13 is set to 0.4 to 0.6 times the axial height of the grid body 11, such as 0.4, 0.5 or 0.6 times.
  • the axial height of the grid body 11 is preferably not greater than the radial maximum diameter of the grid body 11. With this arrangement, the axial height of the entire intravascular interventional treatment device 10 is small, which shortens the release length of the intravascular interventional treatment device 10, reduces the difficulty of operation for doctors, and reduces the impact on the easily ruptured aneurysm top, thereby reducing the risk of rupture during the perioperative period.
  • the intravascular interventional treatment device 10 no longer needs to match the shape of the entire aneurysm cavity, but only needs to fill the neck of the aneurysm, and rely on the force between the outer side 111 of the grid body 11 and the aneurysm wall to achieve stable release of the device. At this time, it can be adapted to aneurysms of various shapes and sizes, and has a wider range of applicability.
  • the ratio between the axial height and the radial maximum diameter of the mesh body 11 is 1/3 to 2/3.
  • the radial maximum diameter of the mesh body 11 should be set according to the size of the aneurysm, and in order to adapt to most aneurysm sizes, the radial maximum diameter of the mesh body 11 in the expanded state can be set to 3 mm to 25 mm.
  • the grid body 11 can have various suitable shapes.
  • the outer contour of the grid body 11 is an oblate spheroid (see FIG. 1 ), a cylindrical shape (see FIG. 5 ) or a truncated cone shape (see FIG. 8 ).
  • the grid body 11 has these shapes, its axial height is small and the release length is short, which reduces the difficulty of operation for doctors while reducing the impact on the easily ruptured aneurysm top, reducing the risk of rupture during the perioperative period, and no longer needs to match the shape of the entire aneurysm cavity.
  • the relative size of the diameter of the outer top surface 112 and the diameter of the outer bottom surface 113 of the grid body 11 should be determined according to the size of the tumor neck opening 22.
  • the diameter of the outer top surface 112 of the grid body 11 is 1.5 to 3 times the diameter of the outer bottom surface 113.
  • the diameter of the outer top surface 112 is 2 times the diameter of the outer bottom surface 113 to ensure that the outer top surface 112 can firmly clamp the tumor wall while the outer bottom surface 113 can also completely cover the tumor neck opening 22.
  • the present application does not impose any restrictions on the locking method between the locking member 121 and the proximal fixing member 14 , and generally adopts a locking method with a simple structure, convenient operation and control, and easy implementation.
  • the locking member 121 has a one-way buckle 123, and the one-way buckle 123 is buckled and connected with the proximal side 141 of the proximal fixing member 14, that is, the proximal side 141 of the proximal fixing member 14 is directly used to achieve one-way locking of the one-way buckle 123.
  • the present application does not limit the structure of the one-way buckle 123, as long as the one-way buckle 123 can be locked in one direction and cannot be disengaged from the proximal fixing member 14 from the distal end.
  • the one-way buckle 123 can also pass through the proximal fixing member 14 from the distal side of the proximal fixing member 14 to the proximal side 141, such as the one-way buckle 123 can be deformed to a certain extent to facilitate passing through the proximal fixing member 14, and return to its original shape after passing through the proximal fixing member 14.
  • the one-way buckle 123 includes but is not limited to the dovetail buckle shown in Fig. 4b. As can be understood by those skilled in the art, it can also be a spherical buckle, a fishbone buckle, a trapezoidal buckle, a conical buckle, and other one-way buckles 123.
  • the proximal side 141 of the proximal fixing member 14 is buckled with the one-way buckle 123.
  • the fixing mechanism 12 pulls the distal end of the intravascular interventional treatment device 10 proximally until the one-way buckle 123 passes through the inner hole of the proximal fixing member 14 and is anchored, so that the intravascular interventional treatment device 10 stably covers the neck of the aneurysm.
  • the one-way buckle 123 is a dovetail lock buckle.
  • the two opposite side wings of the one-way buckle 123 are blocked by the proximal side 141 of the proximal fixing member 14, and will not easily detach from the proximal fixing member 14.
  • the release zone is set on the traction member 122, that is, the release zone is set at the part where the traction member 122 is connected to the one-way buckle 123.
  • the release zone is preferably an electrolytic release zone, which is more convenient to release.
  • the proximal fixing member 14 may be an annular sleeve, and a plurality of mounting holes are provided in the tube wall of the annular sleeve, and the wire heads of each braided wire are inserted into each mounting hole for fixing.
  • the inner hole of the proximal fixing member 14 can allow the one-way buckle 123 to pass through.
  • the inner hole of the proximal fixing member 14 may be a straight hole, as shown in Fig. 4b and Fig. 4d. In other embodiments, the inner hole of the proximal fixing member 14 may be a tapered hole, as shown in Fig. 4f.
  • the one-way buckle 123 is a one-side buckle, which is locked with the proximal side 141 of the proximal fixing member 14 by the trapezoidal locking head on one side of the traction member 122.
  • the one-way buckle 123 is a conical buckle, and the inner hole of the proximal fixing member 14 is a conical hole to match it, and the conical buckle is also locked with the proximal side 141 of the proximal fixing member 14.
  • the microcatheter When the intravascular interventional treatment device 10 provided in the embodiment of the present application is used for surgery, the microcatheter enters the lesion site of the diseased blood vessel aneurysm, and then the entire intravascular interventional treatment device 10 advances in the microcatheter until its distal end reaches the neck 22 of the aneurysm 20.
  • the microcatheter is kept stationary, and the push rod 30 is pushed forward, so that the intravascular interventional treatment device 10 gradually moves into the aneurysm 20.
  • the grid body 11 will continue to expand automatically.
  • the entire intravascular interventional treatment device 10 is pushed out of the microcatheter, the grid body 11 will be completely released in the aneurysm 20.
  • the present embodiment of the application further provides a method for deploying the intravascular interventional treatment device 10 described in the present embodiment of the application, which specifically includes:
  • the intravascular interventional treatment device 10 is pushed along the axial direction of the microcatheter by using the pushing rod 30 until the distal end of the intravascular interventional treatment device 10 reaches the aneurysm neck 22 of the aneurysm 20;
  • the microcatheter is kept stationary, and the pushing rod 30 continues to push the intravascular interventional treatment device 10, so that the intravascular interventional treatment device 10 gradually moves into the aneurysm 20;
  • the intravascular interventional treatment device 10 After the intravascular interventional treatment device 10 is completely pushed out of the distal end of the microcatheter, the intravascular interventional treatment device 10 can be deformed from a free expansion state to a filling state placed in the aneurysm 20;
  • the microcatheter and the push rod 30 are kept stationary, and then force is applied to the fixing mechanism 12, so that the fixing mechanism 12 controls the distal end of the grid body 11 to move closer to the proximal end until the fixing mechanism 12 and the grid body 11 are close to each other. 11 proximal locking;
  • the portion of the fixing mechanism 12 outside the proximal end of the grid body 11 is released, and then the microcatheter, the push rod 30 and the portion of the fixing mechanism 12 outside the proximal end of the grid body 11 are withdrawn, thereby stably fixing the intravascular interventional treatment device 10 at the tumor neck.
  • the fixing mechanism 12 is locked with the proximal fixing member 14 by a one-way buckle 123. After the one-way buckle 123 is locked with the proximal fixing member 14, the part of the traction member 122 located on the proximal side of the locking member 121 is electrolytically released, and finally the microcatheter, the pushing rod 30 and the released part of the traction member 122 are withdrawn.
  • the structure of the intravascular interventional treatment device 10 provided in the first embodiment of the present application can be referred to as shown in FIG. 1 and FIG. 2 .
  • the intravascular interventional treatment device 10 provided in the first embodiment of the present application includes a mesh body 11 and a fixing mechanism 12.
  • the mesh body 11 is preferably woven from braided wire and can be degraded.
  • the fixing mechanism 12 includes a locking member 121 and a traction member 122.
  • the distal end of the mesh body 11 is bound and fixed by a distal fixing member 13.
  • the proximal end of the mesh body 11 is bound and fixed by a proximal fixing member 14.
  • a portion of the traction member 122 penetrates into the mesh body 11 through the proximal end of the mesh body 11, and one end of the traction member 122 is connected to the distal fixing member 13. As shown in FIG.
  • another portion of the traction member 122 extends from the proximal end of the mesh body 11 and further extends through the inner cavity of the push rod 30 to the proximal end of the push rod 30.
  • the locking member 121 is disposed in the mesh body 11 and fixed on the traction member 122, and the traction member 122 can pass through the locking member 121 and be connected thereto. The operator can manipulate the other end of the traction member 122 in vitro to achieve control of the fixing mechanism 12.
  • the locking member 121 may have a dovetail-shaped one-way buckle 123 , and two side wings of the one-way buckle 123 are arranged opposite to each other to form a V-shaped structure.
  • the pulling member 122 may be electrolytically released at the proximal side of the one-way buckle 123 .
  • the outer contour of the grid body 11 is an oblate spherical shape.
  • the axial height of the grid body 11 can be set to 0.5 times its radial maximum diameter, and the axial distance between the one-way buckle 123 and the distal fixing member 13 is 0.4 times the axial height of the grid body 11.
  • the small axial height of the grid body 11 shortens the release length of the intravascular interventional treatment device 10, thereby reducing the difficulty of operation for doctors and the impact on the easily ruptured tumor top, thereby reducing the risk of rupture during the perioperative period.
  • the fixing mechanism 12 is pulled to move the fixing mechanism 12 toward the proximal direction.
  • the axial height of the oblate spherical grid body 11 in the packed state shown in FIG3 is further reduced.
  • the stability of the intravascular interventional treatment device 10 at the aneurysm neck is increased, and the long-term effectiveness of the intravascular interventional treatment device 10 in treating aneurysms is ensured, but also the grid body 11 and the aneurysm wall are better attached, and the aneurysm neck opening 22 can be more effectively covered.
  • the locking between the one-way buckle 123 and the proximal fixing member 14 can be used to limit the axial height of the grid body 11, so that the grid body 11 remains in the current packed state.
  • the intravascular interventional treatment device 10 provided in Example 1 of the present application is in the shape of a flat spheroid when deployed, and will not contact the easily ruptured aneurysm top during the release process, thereby reducing the risk of aneurysm rupture during surgery. Please refer to Figure 3 for details.
  • the intravascular interventional treatment device 10 provided in the second embodiment of the present application includes a mesh body 11 and a fixing mechanism 12.
  • the mesh body 11 is preferably woven from braided wire and can be degraded.
  • the fixing mechanism 12 includes a locking member 121 and a traction member 122.
  • the distal end of the mesh body 11 is bound and fixed by a distal fixing member 13.
  • the proximal end of the mesh body 11 is bound and fixed by a proximal fixing member 14.
  • a portion of the traction member 122 penetrates into the mesh body 11 through the proximal end of the mesh body 11, and one end of the traction member 122 is connected to the distal fixing member 13. As shown in FIG6, another portion of the traction member 122 extends from the proximal end of the mesh body 11 and further extends through the inner cavity of the push rod 30 to the proximal end of the push rod 30.
  • the locking member 121 is arranged in the mesh body 11 and fixed on the traction member 122, and the traction member 122 can pass through the locking member 121 and be connected thereto. The operator can manipulate the other end of the traction member 122 outside the body to control the fixing mechanism 12.
  • the locking member 121 can have a dovetail-shaped one-way buckle 123, with two side wings arranged opposite to each other to form a V-shaped
  • the traction member 122 can be electrolytically released at the proximal side of the one-way buckle 123 .
  • the outer contour of the grid body 11 is cylindrical, and at this time, the axial height of the grid body 11 can be set to 0.4 times of its radial maximum diameter D, and the axial distance between the one-way buckle 123 and the distal fixing member 13 is 0.5 times of the axial height of the grid body 11.
  • the release length of the intravascular interventional treatment device 10 is shortened, which reduces the difficulty of operation for doctors and reduces the impact on the easily ruptured tumor top, thereby reducing the risk of rupture during the perioperative period.
  • the fixing mechanism 12 is pulled to move the fixing mechanism 12 toward the proximal direction.
  • the axial height of the cylindrical grid body 11 in the packed state shown in FIG6 is further reduced, which not only increases the force between the outer side 111 of the grid body 11 and the aneurysm wall, increases the stability of the intravascular interventional treatment device 10 at the aneurysm neck, ensures the long-term effectiveness of the intravascular interventional treatment device 10 in treating aneurysms, but also makes the grid body 11 better in contact with the aneurysm wall, and can more effectively cover the aneurysm neck 22.
  • the one-way buckle 123 is locked with the proximal fixing member 14, the axial height of the grid body 11 can be limited, so that the grid body 11 remains in the current packed state.
  • the intravascular interventional treatment device 10 provided in the second embodiment of the present application is cylindrical in shape when deployed, and will not contact the easily ruptured aneurysm top during the release process, thereby reducing the risk of aneurysm rupture during surgery, as shown in Figure 6.
  • the cylindrical shape has better radial support force, which can increase the force between the outer side 111 of the intravascular interventional treatment device 10 and the aneurysm wall, and improve the stability of the intravascular interventional treatment device 10 in covering the aneurysm neck 22.
  • the intravascular interventional treatment device 10 provided in the third embodiment of the present application includes a mesh body 11 and a fixing mechanism 12.
  • the mesh body 11 is preferably woven from braided silk and is degradable.
  • the fixing mechanism 12 includes a locking member 121 and a traction member 122.
  • the distal end of the mesh body 11 is restrained and fixed by a distal fixing member 13.
  • the proximal end of the mesh body 11 is restrained and fixed by a proximal fixing member 14.
  • a portion of the traction member 122 penetrates into the mesh body 11 through the proximal end of the mesh body 11, and one end of the traction member 122 is aligned with the distal fixing member 13. Connection. As shown in Figure 9, another part of the traction member 122 extends from the proximal end of the grid body 11, and further extends through the inner cavity of the push rod 30 to the proximal end of the push rod 30.
  • the locking member 121 is arranged in the grid body 11 and fixed on the traction member 122, and the traction member 122 can pass through the locking member 121 and be connected thereto. The operator can manipulate the other end of the traction member 122 in vitro to achieve control of the fixing mechanism 12.
  • the locking member 121 can have a dovetail-shaped one-way buckle 123, and the two side wings are arranged opposite to each other to form a V-shaped structure.
  • the traction member 122 can be electrolytically released on the proximal side of the one-way buckle 123.
  • the outer contour of the grid body 11 is truncated cone-shaped.
  • the axial height of the grid body 11 can be set to 0.6 times its radial maximum diameter D, and the axial distance between the one-way buckle 123 and the distal fixing member 13 is 0.6 times the axial height of the grid body 11.
  • the axial height of the truncated cone-shaped grid body 11 is also small, which shortens the release length of the intravascular interventional treatment device 10, reduces the difficulty of operation for doctors, and reduces the impact on the easily ruptured aneurysm top, thereby reducing the risk of rupture during the perioperative period.
  • the diameter of the outer top surface 112 of the truncated cone-shaped grid body 11 is twice the diameter of the outer bottom surface 113, which facilitates the grid body 11 to better engage with the aneurysm wall and ensure that the aneurysm neck 22 is covered.
  • the truncated cone-shaped outer contour of the grid body 11 after unfolding is easier to clamp in the aneurysm 20, so that the length of the one-way buckle 123 pulled down in the proximal direction can also be shorter, as shown in FIG9.
  • the fixing mechanism 12 is pulled to move the fixing mechanism 12 toward the proximal direction.
  • the axial height of the truncated cone-shaped grid body 11 in the packed state shown in FIG9 is further reduced, which not only increases the force between the outer side 111 of the grid body 11 and the aneurysm wall, increases the stability of the intravascular interventional treatment device 10 at the aneurysm neck, ensures the long-term effectiveness of the intravascular interventional treatment device 10 in treating aneurysms, but also makes the grid body 11 better in contact with the aneurysm wall, and can more effectively cover the aneurysm neck 22.
  • the one-way buckle 123 is locked with the proximal fixing member 14
  • the axial height of the grid body 11 is restricted from changing, so that the grid body 11 remains in the current packed state.
  • the intravascular interventional treatment device 10 provided in the third embodiment of the present application is in a truncated cone shape when deployed, and will not contact the aneurysm top part that is prone to rupture during the release process, thereby reducing the risk of aneurysm rupture during surgery.
  • the truncated cone shape has better radial support force, which can increase the intravascular interventional treatment device 10 The force between the outer side surface 111 and the tumor wall is increased to improve the stability of the intravascular interventional treatment device 10 when covering the tumor neck.
  • the outer contour of the grid body 11 when unfolded may not be in the shape of an oblate spheroid, a cylinder or a truncated cone.
  • the intravascular interventional treatment device takes into account both flexibility and long-term packing stability, ensuring the packing effect of the aneurysm. In addition, it only fills part of the aneurysm cavity, and the release length in the aneurysm is short, which can reduce the difficulty of the doctor's operation during the operation and reduce the operation time. It is completely located in the aneurysm, which can avoid the use of dual antiplatelet drugs. It can further achieve stable packing through the interference effect between the outer side and the aneurysm wall without filling the entire aneurysm cavity. It can adapt to more aneurysm shapes and expand the scope of application.
  • the radial maximum diameter of the grid body in the expanded state is greater than the axial height, the impact on the aneurysm top can be reduced, reducing the risk of rupture. Furthermore, after the aneurysm heals, the grid body can be gradually degraded to reduce the occurrence of space-occupying effect, and it also solves the problem that the degradable grid body is difficult to return to the initial expansion state and cannot be used for aneurysm packing.

Landscapes

  • Surgical Instruments (AREA)

Abstract

L'invention concerne un appareil de thérapie d'intervention intravasculaire ayant un état expansé et un état comprimé. L'appareil de thérapie d'intervention intravasculaire comprend un corps de grille et un mécanisme de fixation. Au moins une partie du mécanisme de fixation est disposée dans le corps de grille, et une extrémité du mécanisme de fixation est reliée à une extrémité distale du corps de grille. Dans l'état expansé, le mécanisme de fixation peut être sollicité pour se déplacer de façon à entraîner l'extrémité distale du corps de grille à se déplacer dans la direction axiale du corps de grille, ajustant ainsi la hauteur axiale du corps de grille. Le mécanisme de fixation après le mouvement peut être verrouillé à une extrémité proximale du corps de grille de façon à limiter la hauteur axiale du corps de grille et permettre à l'appareil de thérapie d'intervention intravasculaire de remplir une partie de l'espace d'une cavité cible pour éviter la partie supérieure de la cavité cible et recouvrir le col de la cavité cible. Un tel agencement permet une meilleure adhérence du corps de grille à la paroi anévrismale et une meilleure couverture du col anévrismal, ce qui permet de réduire l'influence sur le sommet anévrismal qui est sensible aux lésions, et d'assurer la stabilité à long terme de la couverture du col anévrismal.
PCT/CN2023/129273 2022-12-15 2023-11-02 Appareil de thérapie d'intervention intravasculaire WO2024125147A1 (fr)

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CN202211613484.8 2022-12-15
CN202211613484.8A CN118203378A (zh) 2022-12-15 2022-12-15 血管内介入治疗装置

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Citations (7)

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US20060167494A1 (en) * 2005-01-21 2006-07-27 Loubert Suddaby Aneurysm repair method and apparatus
DE102013106031A1 (de) * 2013-06-11 2014-12-11 Acandis Gmbh & Co. Kg Medizinisches Implantat und System mit einem derartigen Implantat
CN104771200A (zh) * 2015-04-15 2015-07-15 中国人民解放军第二军医大学 颅内动脉瘤瘤颈重建装置
CN105105812A (zh) * 2015-09-18 2015-12-02 王奎重 一种颅内动脉瘤介入栓塞治疗装置
CN113069170A (zh) * 2021-04-30 2021-07-06 上海暖阳医疗器械有限公司 一种动脉瘤闭塞装置
US20210212698A1 (en) * 2008-05-01 2021-07-15 Aneuclose Llc Proximal Concave Neck Bridge with Central Lumen and Distal Net for Occluding Cerebral Aneurysms
CN114129218A (zh) * 2021-12-31 2022-03-04 上海暖阳医疗器械有限公司 一种动脉瘤瘤内闭塞装置

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060167494A1 (en) * 2005-01-21 2006-07-27 Loubert Suddaby Aneurysm repair method and apparatus
US20210212698A1 (en) * 2008-05-01 2021-07-15 Aneuclose Llc Proximal Concave Neck Bridge with Central Lumen and Distal Net for Occluding Cerebral Aneurysms
DE102013106031A1 (de) * 2013-06-11 2014-12-11 Acandis Gmbh & Co. Kg Medizinisches Implantat und System mit einem derartigen Implantat
CN104771200A (zh) * 2015-04-15 2015-07-15 中国人民解放军第二军医大学 颅内动脉瘤瘤颈重建装置
CN105105812A (zh) * 2015-09-18 2015-12-02 王奎重 一种颅内动脉瘤介入栓塞治疗装置
CN113069170A (zh) * 2021-04-30 2021-07-06 上海暖阳医疗器械有限公司 一种动脉瘤闭塞装置
CN114129218A (zh) * 2021-12-31 2022-03-04 上海暖阳医疗器械有限公司 一种动脉瘤瘤内闭塞装置

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