WO2024125147A1 - 血管内介入治疗装置 - Google Patents
血管内介入治疗装置 Download PDFInfo
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- 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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- grid body
- treatment device
- interventional treatment
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- intravascular interventional
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Definitions
- 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.
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Abstract
一种血管内介入治疗装置，具有展开状态和压缩状态。血管内介入治疗装置包括网格体和固定机构，至少部分固定机构置于网格体中，并使其一端与网格体的远端连接，在展开状态下，固定机构能够受力运动，以驱使网格体的远端沿网格体的轴向运动，进而调整网格体的轴向高度，且运动后的固定机构能够与网格体的近端锁定，以限制网格体的轴向高度，并使得血管内介入治疗装置仅填塞目标腔体的部分空间，以避开目标腔体的腔顶，并同时覆盖目标腔体的颈口。这样布置后，使得网格体与瘤壁之间的贴合性更好，瘤颈也覆盖更完全，还可减少对易破裂瘤顶的影响，并保持瘤颈覆盖的长期稳定性。
Description
本发明涉及医疗器械技术领域，具体涉及一种用于动脉瘤填塞的血管内介入治疗装置。
颅内动脉瘤是一种临床上常见的脑血管病，具有较高的致死、致残率。一项无创影像学研究结果显示，中国人颅内动脉瘤的患病率为7％。颅内动脉瘤破裂引起的蛛网膜下腔出血30天内的病死率高达45％，存活者中约30％伴有不同程度的神经功能缺损。大型和巨大型动脉瘤亦可引起颅内占位效应，压迫脑组织及脑神经导致相应的临床症状。
颅内动脉瘤的传统治疗方式是开颅夹闭术，而血管内治疗因其微创伤的特性，在过去的20余年得到了快速发展。尤其是在国际蛛网膜下腔出血动脉瘤试验(International Subarachnoid Aneurysm Trial，ISAT)的中长期结果显示血管内治疗在残死率、癫痫发病率等方面优于手术夹闭术，血管内治疗成为越来越多颅内动脉瘤的首选治疗方法。目前市场上常用的介入治疗产品有弹簧圈及辅助弹簧圈栓塞的支架、覆膜支架、血流导向装置和瘤腔栓塞器械。弹簧圈栓塞依靠预成形的弹簧圈从导管释放到动脉瘤中进行填充，导致动脉瘤腔内的血流变缓淤滞，从而引起凝块的形成并排除血液的进一步流入，由此防止动脉瘤的进一步扩张。但对于宽颈和分叉部动脉瘤，弹簧圈栓塞时需要植入额外的装置以避免弹簧圈疝出，例如辅助支架或血流导向装置。多个装置的使用增加了手术时间、治疗成本和不良事件的可能性。覆膜支架和血流导向装置是通过血管重建治疗动脉瘤，其应用提高了大型、巨大动脉瘤的长期疗效。但是，覆膜支架不适用于分叉部位，也不适用于有穿支血管的载瘤动脉，使用范围受限。血流导向装置的植入使病人长期依赖双重抗血小板治疗，术后有出血性并发症的风险；同时对于分叉部动脉瘤使用血流导向装置有堵塞分支血管的风险。另外，单独使用血流导向装置治疗部分大型动脉
瘤后有一定迟发破裂风险。目前，还有一些新型的瘤腔内栓塞器械(如WEB装置、Artisse装置、Contour装置)，通常由形状记忆材料制备而成，预制定型，通过导管传送，到达特定位置后从鞘管内推出，自膨回复至预制形状，进而达到封堵动脉瘤的目的。然而目前颅内动脉瘤的血管内治疗方式还存在以下几方面问题：
1)弹簧圈栓塞效率较低，对医生技巧和经验的要求较高，单独使用时会有疝出动脉瘤的风险，与其他器械配合使用，会增加产生缺血并发症的风险；
2)覆膜支架适用位置有限，且容易将载瘤动脉拉直，改变血管的原本走形；
3)血流导向装置术后需长期服用双重抗血小板药物，有出血性并发症的风险，且不适用于带穿支血管的载瘤动脉；
4)对于新型的瘤腔内栓塞器械：WEB装置主要适用于治疗分叉部的宽径动脉瘤，且对规则动脉瘤尤其适用，装置释放长度较长，远端铆点对瘤壁有冲击作用，且单个球形或柱形结构与动脉瘤内壁的贴合程度有限，长期植入后容易挤压移位；Artisse装置同WEB装置的工作原理基本相似，虽没有远端铆点，但其球形结构也需完全贴合瘤壁才能发挥较好的栓塞作用；Contour装置为圆片状，适用于分叉部或顶端动脉瘤，而且需反复调整位置，才能使装置能够完全覆盖瘤颈，否则会影响装置在瘤内的稳定性。
需要说明的是，公开于该发明背景技术部分的信息仅仅旨在加深对本发明一般背景技术的理解，而不应当被视为承认或以任何形式暗示该信息构成已为本领域技术人员所公知的现有技术。
发明内容
本发明的目的在于提供一种血管内介入治疗装置，以解决现有技术中针对动脉瘤的血管内治疗方式所存在的至少一个技术问题。
为实现上述目的，本发明提供了一种血管内介入治疗装置，具有展开状态和压缩状态，其包括网格体和固定机构；至少部分所述固定机构置于所述
网格体中，并使所述固定机构的一端与所述网格体的远端连接；在所述展开状态下，所述固定机构能够受力运动，以驱使所述网格体的远端沿所述网格体的轴向运动，进而调整所述网格体的轴向高度，且运动后的所述固定机构还能够与所述网格体的近端锁定，以限制所述网格体的轴向高度，并使得所述血管内介入治疗装置仅填塞目标腔体的部分空间，以避开所述目标腔体的腔顶，并同时覆盖所述目标腔体的颈口。
可选地，所述固定机构包括牵引件和锁定件；至少部分所述牵引件经由所述网格体的近端置于所述网格体中，且所述牵引件的一端与所述网格体的远端连接；所述锁定件与所述牵引件连接，并置于所述网格体中；在所述展开状态下，当所述牵引件和/或所述锁定件受力运动时，所述固定机构通过所述牵引件驱使所述网格体的远端沿轴向运动，直至运动后的所述锁定件与所述网格体的近端锁定。
可选地，所述牵引件的远端部分经由所述网格体的近端置于所述网格体中，且所述牵引件的一端与所述网格体的远端连接；所述牵引件的近端部分从所述网格体的近端伸出，以使所述牵引件的另一端暴露在所述网格体外；所述锁定件的近端侧设有解脱区；所述固定件与所述网格体的近端锁定后，所述解脱区用于控制所述近端部分和所述远端部分之间的解脱。
可选地，所述血管内介入治疗装置还包括近端固定件和远端固定件，所述网格体的近端由所述近端固定件束缚固定，所述网格体的远端由所述远端固定件束缚固定，所述牵引件的一端与所述远端固定件连接，所述锁定件用于与所述近端固定件锁定。
可选地，在所述展开状态下，所述锁定件具有初始位置和锁定位置；在所述初始位置，所述锁定件与所述近端固定件分离；在所述锁定位置，所述锁定件与所述近端固定件锁定；其中，所述初始位置与所述远端固定件之间的轴向距离小于所述网格体的轴向高度。
可选地，在所述展开状态下，所述初始位置与所述远端固定件之间的轴向距离为所述网格体的轴向高度的0.4倍～0.6倍。
可选地，所述锁定件具有单向扣，所述单向扣与所述近端固定件的近端侧扣合连接。
可选地，在所述展开状态下，所述网格体的径向最大直径大于所述目标腔体对应位置处的直径，以通过所述网格体与所述目标腔体的腔壁之间的作用力固定所述血管内介入治疗装置。
可选地，在所述展开状态下，所述网格体的轴向高度不大于所述网格体的径向最大直径。
可选地，在所述展开状态下，所述网格体的轴向高度与径向最大直径之间的比值为1/3～2/3。
可选地，在所述展开状态下，所述网格体的径向最大直径为3mm～25mm。
可选地，在所述展开状态下，所述网格体的外轮廓形状为扁球形状、圆柱形状或圆台形状。
可选地，当所述网格体的外轮廓形状为圆台形状时，所述网格体的外顶面的直径为外底面直径的1.5～3倍。
可选地，所述网格体由生物可降解材料制备而成。
可选地，制备所述网格体的生物可降解材料为以下材料的一种或多种组合：聚对二氧环己酮、丙交酯-ε-己内酯共聚物、聚乳酸、聚乳酸-羟基乙酸共聚物及其混合物。
可选地，所述网格体为编织结构，所述编织结构中的编织丝的丝径为0.001in～0.003in，所述编织丝的数目为48根～144根。
本发明还提供了一种针对任一项所述的血管内介入治疗装置的展开方法，包括：
将所述血管内介入治疗装置置于微导管的内腔中，使所述血管内介入治疗装置处于压缩状态；
利用推送杆沿所述微导管的轴向推送所述血管内介入治疗装置，直至所述血管内介入治疗装置的远端到达动脉瘤的颈口；
保持所述微导管不动，通过推送杆推动所述血管内介入治疗装置，使得
所述血管内介入治疗装置逐渐朝所述动脉瘤内移动；
所述血管内介入治疗装置被完全推出所述微导管后，使所述血管内介入治疗装置从自由扩张状态变形为置于所述动脉瘤中的填塞状态；
在所述填塞状态下，保持微导管和推送杆不动，然后施力于所述固定机构，使所述固定机构控制所述网格体的远端沿网格体的轴向运动，直至所述固定机构与所述网格体的近端锁定；
所述固定机构与所述网格体的近端锁定后，若固定机构有部分结构设置于网格体的外部，则解脱所述固定机构位于所述网格体的近端外的部分，然后，撤离微导管、推送杆以及固定机构位于所述网格体的近端外的部分，即可将血管内介入治疗装置稳定固定在瘤颈部位。
本发明提供的血管内介入治疗装置至少能够取得以下的有益效果：
以上血管内介入治疗装置具有展开状态和压缩状态，其特征在于，包括网格体和固定机构；至少部分所述固定机构置于所述网格体中，并使所述固定机构的一端与所述网格体的远端连接；在所述展开状态下，所述固定机构能够受力运动，以驱使所述网格体的远端沿网格体的轴向运动，进而调整所述网格体的轴向高度，且运动后的所述固定机构能够与所述网格体的近端锁定，以限制所述网格体的轴向高度就，并使得血管内介入治疗装置仅填塞目标腔体的部分空间，以避开所述目标腔体的腔顶，并同时覆盖所述目标腔体的颈口。
以目标腔体为动脉瘤进行示意说明，采用上述布置后，当血管内介入治疗装置以展开状态填塞在动脉瘤内时，仅填塞在动脉瘤的下部分瘤腔，在填塞过程中避开了动脉瘤的上部分瘤顶，可减小对易破裂动脉瘤顶的影响，并降低大型动脉瘤的占位效应，并且在固定机构的作用下，能调整血管内介入治疗装置的轴向高度，也能调整血管内介入治疗装置的径向形态，最终使得血管内介入治疗装置可稳定填塞在瘤颈部位，确保血管内介入治疗装置治疗动脉瘤时的长期有效性，同时网格体与瘤壁之间的贴合性更好，瘤颈也覆盖更完全。此外，还可通过网格体的密网的扰流作用，降低血液对瘤腔的冲击，
其次，由于血管内介入治疗装置仅需考虑瘤颈的覆盖，使其不需要完全适应动脉瘤的形状，进而可适用于不同动脉瘤的填塞，扩大了血管内介入治疗装置的可适用范围。
进一步地，在展开状态下，网格体的轴向高度小于网格体的径向最大直径。采用该布置后，网格体的轴向高度小，使得血管内介入治疗装置的释放长度变短，在降低医生操作难度的同时减少对容易破裂的瘤顶的影响，降低围手术期的破裂风险。进一步地，网格体由可降解材料制备而成，在瘤颈完成内皮化后可被人体降解吸收，进而减少人体内的异物存在的同时进一步降低占位效应，此时固定机构还可帮助可降解网格体回复至初始扩张状态，从而提高可降解的网格体的形状回复性，确保其贴壁性能和支撑性能，待瘤颈愈合后，网格体逐步降解完成，减少占位效应的发生。
本发明提供的附图并不需要按比例画图，且一些部件和结构为了清楚而扩大。可以考虑图示实施例的变化形式。因此，在附图中的实施例的多个方面和元件的介绍并不用于限制本发明的范围。在附图中：
图1为本发明实施例一的血管内介入治疗装置在展开状态时的主视结构示意图；
图2为本发明实施例一的血管内介入治疗装置在展开状态时的俯视结构示意图；
图3为本发明实施例一的血管内介入治疗装置从微导管推出释放在动脉瘤内的场景示意图；
图4a为本发明实施例一的血管内介入治疗装置从自由扩张状态变形为在动脉瘤内填塞状态时的场景示意图，其中双向箭头H表示高度方向；
图4b为本发明实施例一的一种单向锁定方式，其中单向扣为燕尾状锁扣；
图4c和图4d为本发明实施例一的另一种单向锁定方式，其中单向扣为单侧锁扣；
图4e和图4f为本发明实施例一的又一种单向锁定方式，其中单向扣为锥形锁扣；
图5为本发明实施例二的血管内介入治疗装置的主视结构示意图；
图6为本发明实施例二的血管内介入治疗装置从微导管推出释放在动脉瘤内的场景示意图；
图7为本发明实施例二的血管内介入治疗装置从自由扩张状态变形为在动脉瘤内填塞状态时的场景示意图；
图8为本发明实施例三的血管内介入治疗装置在展开状态时的主视结构示意图；
图9为本发明实施例三的血管内介入治疗装置从微导管推出释放在动脉瘤内的场景示意图；
图10为本发明实施例三的血管内介入治疗装置从自由扩张状态变形为在动脉瘤内填塞状态时的场景示意图。
附图中标号说明如下：
10-血管内介入治疗装置；11-网格体；111-外侧面；112-外顶面；113-外
底面；12-固定机构；121-锁定件；122-牵引件；123-单向扣；13-远端固定件；14-近端固定件；141-近端侧；20-动脉瘤；21-瘤顶；22-瘤颈口；30-推送杆；H-沿轴向高度方向；D-径向最大直径。
10-血管内介入治疗装置；11-网格体；111-外侧面；112-外顶面；113-外
底面；12-固定机构；121-锁定件；122-牵引件；123-单向扣；13-远端固定件；14-近端固定件；141-近端侧；20-动脉瘤；21-瘤顶；22-瘤颈口；30-推送杆；H-沿轴向高度方向；D-径向最大直径。
下面将介绍各种示例实施例。这些实例为非限定的，应当知道，它们用于示例说明装置、***和方法的更广义应用方面。在不脱离本发明的真正精神和范围的情况下，这些实施例可以进行多种变化，且可以由等效物代替。此外，可以进行多种变化，以便适应特殊的情况、材料、物质组分、处理、处理动作或步骤来适应本发明的目的、精神或范围。所有这些变化都将在本发明的保护范围内。
对于在概述或详细说明中介绍的任何尺寸，它们将只是实例，并不是限
制本发明主题，除非在各种示例实施例中提出。而且，本文中所述的实施例的多种结构将彼此补充，而不是纯粹交替，除非这样说明。换句话说，来自一个实施例的结构可以与其它实施例的结构自由地组合，如本领域普通技术人员很容易知道，除非说明这些结构只用于替换。还应当理解的是，除非特别说明或者指出，否则说明书中的术语“第一”、“第二”、“第三”等描述仅仅用于区分说明书中的各个组件、元素、步骤等，而不是用于表示各个组件、元素、步骤之间的逻辑关系或者顺序关系等。
在本申请文件中，“近端”和“远端”是从使用该血管内介入治疗装置的医生角度来看相对于彼此的元件或动作的相对方位、相对位置、方向，尽管“近端”和“远端”并非是限制性的，但是“近端”通常指该血管内介入治疗装置在正常操作过程中靠近医生的一端，而“远端”通常是指首先进入患者体内的一端。相应的“近端侧”通常指对应“近端”的一侧的表面，而“远端侧”通常指对应“远端”的一侧的表面。本申请文件中的“远端”和“近端”并不指向结构的端部，而是相对位置，例如网格体的远端并不是网格体的端部，而是相对靠近网格体端部的位置。
在本申请文件中，血管内介入治疗装置的“轴向”通常指填塞在动脉瘤内时沿瘤颈口与瘤顶之间的高度方向；血管内介入治疗装置的“径向”通常指填塞在动脉瘤内时沿瘤颈口直径方向。
在本申请文件中，血管内介入治疗装置的“展开状态”包括无外力作用时的“自由扩张状态”，以及填塞在动脉瘤内时受瘤壁约束时的“填塞状态”；“径向最大直径”是指，将血管内介入治疗装置投影到沿直径方向的平面上的投影面的最大直径。
在本申请文件中，目标腔体主要指动脉瘤，特别是颅内动脉瘤；目标腔体的腔顶指动脉瘤的瘤顶；目标腔体的颈口是指动脉瘤的瘤颈口；目标腔体的腔壁指的是瘤壁；目标腔体的部分空间对应的是动脉瘤的下部分瘤腔，下部分瘤腔的大小不做限制。
本申请的核心思想在于，提供一种血管内介入治疗装置，包括但不仅限
于对颅内动脉瘤的填塞，其具体实施例可参考图1至图10。
如图1至图3、图4a至图4f以及图5至图10所示，本申请实施例提供的血管内介入治疗装置10具有展开状态和压缩状态，并且可在展开状态和压缩状态之间切换。血管内介入治疗装置10可通过微导管输送，其在微导管内的形态为压缩状态，推出微导管后恢复至自由扩张状态。血管内介入治疗装置10可进一步从自由扩张状态变形为在动脉瘤内填塞时的填塞状态。
本申请实施例提供的血管内介入治疗装置10包括网格体11和固定机构12。网格体11为三维网格体，主要为笼状结构。至少部分固定机构12置于网格体11中，并使固定机构12的一端与网格体11的远端连接。
图示的实施方式中，固定机构12的一部分经由网格体11的近端置于网格体11中，且固定机构12的一端与网格体11的远端连接，固定机构12的另一部分从网格体11的近端伸出，以使固定机构12的另一端暴露在网格体11外。此时，可直接施力于固定机构12暴露在外的另一端，便可控制固定机构12运动，不必额外配置外部结构来控制固定机构12，从而使结构更简单，手术操作更方便。
在其他实施例中，固定机构12全部经由网格体11的近端置于网格体11中，且固定机构12的一端与网格体11的远端连接，固定机构12的另一端则需要与外部结构连接，外部结构应当经由网格体11的近端进入网格体11与固定机构12连接，从而在外部结构的作用下控制固定机构12运动。此时，通过施力于外部结构而实现对固定机构12的控制。外部结构一般为丝、绳、线、带材等柔性线状体。
由此，当血管内介入治疗装置10在动脉瘤20内填塞时，通过控制固定机构12，使固定机构12受力运动，便可通过固定机构12驱使网格体11的远端沿网格体11的轴向运动，以此调整网格体11的轴向高度，且将运动后的固定机构12与网格体11的近端锁定，从而限制网格体11的轴向高度，使得网格体11保持在当前形态，具体可参见图4a、图7及图10。
更详细地，当固定机构12受力运动，可促使网格体11的远端向网格体
11的近端运动，以调整网格体11的近端和远端之间的轴向距离。此时，在固定机构12的作用下，一方面可促使网格体11与瘤壁更好的贴合，贴合更为紧密，并促使网格体11更好的覆盖瘤颈口22，同时可促进网格体11和瘤壁之间形成过盈状态，以便通过网格体11与瘤壁之间的作用力，将血管内介入治疗装置10稳定填塞在瘤颈部位，确保血管内介入治疗装置10治疗动脉瘤时的长期有效性，另一方面，在固定机构12的作用下，方便调整网格体11的填塞形态，使得血管内介入治疗装置10可以适配各种动脉瘤。
如图1和3所示，本申请实施例提供的血管内介入治疗装置10主要通过自身与瘤壁之间的相互作用而稳定地固定在瘤腔内，并有效覆盖瘤颈口22。瘤壁与血管内介入治疗装置10之间的相互作用是指两者之间的过盈配合以及两者之间的摩擦力。过盈配合可以理解为，在展开状态下，网格体11的径向最大直径大于瘤腔对应位置处的直径，使得血管内介入治疗装置10通过自身扩张力锚定在瘤壁上。瘤腔对应位置处的直径可以是瘤腔的最大直径或某一位置的较小直径。
除以上所述外，当固定机构12与网格体11的近端锁定后，也使得血管内介入治疗装置10还被配置为在展开状态下仅填塞动脉瘤20的下部分瘤腔，即仅填塞在瘤颈部位，未填满整个动脉瘤20的瘤腔，这样设置，便于血管内介入治疗装置10在填塞过程中避开动脉瘤20的瘤顶21，避免对瘤顶的冲击，同时还能够确保覆盖瘤颈口22，具体可参见图3、图6和图9。因此，瘤腔被部分填塞时，在有效覆盖瘤颈口22的同时，还可减小对易破裂动脉瘤顶的影响，并降低大型动脉瘤的占位效应。此外，由于血管内介入治疗装置10仅需考虑瘤颈的覆盖，不需要完全适应动脉瘤的形状，因而可适用于不同动脉瘤，扩大了血管内介入治疗装置10的可适用范围。
如本领域技术人员可以理解，本申请实施例提供的血管内介入治疗装置10围绕动脉瘤20展开长度应小于整个动脉瘤20的周长，以便血管内介入治疗装置10仅填塞下部分瘤腔，但同时还能够覆盖瘤颈口22。进一步地，本申请实施例提供的血管内介入治疗装置10围绕动脉瘤20展开长度不超过整个
动脉瘤20的周长的2/3，且不小于整个动脉瘤20的周长的1/2。动脉瘤20的周长应理解为动脉瘤20沿瘤颈口22到瘤颈21的整个腔壁的周长。
还应理解，由于网格体11具有密网，通过密网的扰流作用，还能降低血流对动脉瘤腔的冲击，减小动脉瘤破裂的风险，同时为瘤颈的修复提供可攀爬的脚手架，有助于瘤颈口的内皮化。本文中，“密网”通常是指材料空白率不超过80％的网格体11，即材料覆盖率不小于20％的网格体11。
网格体11较佳地由生物可降解材料制备而成，便于在瘤颈完成内皮化后，使网格体11可被人体降解吸收，减少人体内的异物存在的同时进一步降低占位效应的可能。在其他实施例中，网格体11不可降解，也在本申请的保护范围之内。
制备网格体11的生物可降解材料可以为各种合适的生物可降解材料。制备网格体11的生物可降解材料应当选择降解周期长的材料，以避免网格体11在瘤颈完成内皮化之前便完全失去力学性能。例如，制备网格体11的生物可降解材料选自聚对二氧环己酮(PDO)、丙交酯-ε-己内酯共聚物(PLC)、聚乳酸(PLA)、聚乳酸-羟基乙酸共聚物(PLGA)及其混合物，且制备网格体11的生物可降解材料可以由一种或多种生物可降解材料组合制备。所应理解，此处所示意的生物可降解材料的降解周期长，至少达到一年以上，可以确保瘤颈完成内皮化后才会完全失去力学性能。
当网格体11可降解时，鉴于可降解高分子材料形状回复能力和力学强度都低于金属材料(如镍钛合金)，通过微导管等输送后，网格体11一般较难回复至初始扩张状态。为此，固定机构12的作用还在于帮助可降解的网格体11回复至初始扩张状态，从而提高可降解的网格体11的形状回复性，确保其贴壁性能和支撑性能。待瘤颈愈合后，网格体11逐步降解完成，减少占位效应的发生。网格体11主要为编织结构，由多根编织丝交汇编织而成。编织成型的网格体11的柔顺性好。编织方式可以有多种，所有编织丝在网格体11的近端汇聚形成近端汇聚点，并在远端汇聚形成远端汇聚点。所有编织丝在网格体11的近端和远端之间形成整个网格体的编织网面。
如图4a、图7及图10所示，在展开状态下，网格体11的编织网面可根据在动脉瘤20内的填塞情况理解，具体可包括外侧面111、外顶面112和外底面113，外侧面111设置在外顶面112和外底面113之间，外顶面112和外底面113分别与外侧面111邻接，外顶面112与瘤顶21相对，外底面113覆盖瘤颈口22，外侧面111至少部分贴靠瘤颈口22径向两侧的瘤壁，而外顶面112远离瘤顶21以使得瘤顶21与外顶面112之间形成非填塞区。还应理解，即便编织丝在网格体11的远端汇聚，但由于网格体11不完全填塞动脉瘤20，因此可以避免远端汇聚点对动脉瘤20的冲击，减小损伤动脉瘤的风险，而且网格体11的近端汇聚点也不会轻易疝出到载瘤动脉中，减小了对载瘤动脉中血流的影响。
本申请实施例提供的血管内介入治疗装置10应当具有较好的柔顺性和支撑性，为此，在一些实施方式中，将网格体11中编织丝的丝径设置为0.001in～0.003in，编织丝的根数设置为48根～144根。
所述远端汇聚点上通常设置有远端固定件13，所述近端汇聚点上通常设置有近端固定件14。近端固定件14束缚固定网格体11近端处的编织丝丝头，远端固定件13束缚固定网格体11远端处的编织丝丝头。本实施例中，固定机构12的一端与远端固定件13连接，且运动后的固定机构12与近端固定件14锁定。
如图1所示，在一些实施例中，近端固定件14与推送杆30可解脱地连接，两者之间可以是各种可解脱的连接方式，如机械解脱、电解脱或其他合适的解脱方式。在另一些实施例中，近端固定件14与推送杆30仅抵靠，两者不连接。无论推送杆30与近端固定件14连接或抵靠，推送杆30均可推动血管内介入治疗装置10在微导管内沿微导管的轴向运动。而当推送杆30与近端固定件14仅抵靠时，若释放位置不合适，也可通过固定机构12控制血管内介入治疗装置10的回收，以便重新调整血管内介入治疗装置10的位置。
如图1和图3所示，作为一实施方式，固定机构12包括锁定件121和牵引件122。至少部分牵引件122经由网格体11的近端置于网格体11中，且牵
引件122的一端与网格体11的远端连接。锁定件121与牵引件122连接，并置于网格体11中。在展开状态下，当牵引件122和锁定件121中的至少一个受力运动时，固定机构12即可通过牵引件122驱使网格体11的远端沿轴向运动，直至锁定件121与网格体11的近端锁定。牵引件122一般为丝、线、绳、带等较为柔软的线状体。锁定件121可以是各种能够实现单向锁定的机械结构，包括但不仅限于采用单向扣123，本申请对此不限定。此外，当锁定件121与网格体11的近端锁定后，牵引件122位于网格体11的远端和锁定件121之间的远端部分应当处于绷直状态。
本实施例中，牵引件122的远端部分经由网格体11的近端置于网格体11中，且牵引件122的一端与网格体11的远端连接，优选牵引件122的一端与远端固定件13连接；牵引件122的近端部分从网格体11的近端伸出，以使牵引件122的另一端暴露在网格体11外。此时，操作者只需要控制牵引件122的该另一端，即可控制整个固定机构12运动，牵引件122的近端部分还需穿过推送杆30的内腔，使牵引件122的该另一端延伸至推送杆30的近端，如可与推送杆30近端上的推送手柄连接。进一步地，锁定件121用于与近端固定件14锁定。根据锁定件121，可将牵引件122分为近端部分和远端部分，远端部分位于锁定件121的远端侧，近端部分位于锁定件121的近端侧，当锁定件121与网格体11的近端锁定后，远端部分位于网格体11内，近端部分则位于网格体11外。
鉴于锁定件121锁定后，牵引件122伸出网格体11近端外的近端部分需要撤离人体，为了解决该问题，在一具体实施例中，锁定件121的近端侧设置有解脱区，通过解脱区控制牵引件122的近端部分和远端部分之间的解脱，优选近端部分和远端部分电解脱，使得牵引件122在网格体11外的近端部分与在网格体11内的远端部分分离。牵引件122的两部分分离后，牵引件122在网格体11外的近端部分可被抽离人体。
在展开状态下，锁定件121可具有初始位置和锁定位置；在初始位置，锁定件121与近端固定件14分离；在锁定位置，锁定件121与近端固定件14
锁定。初始位置应该理解为固定机构12在运动之前锁定件121的位置。初始位置与远端固定件13之间的轴向距离应当小于网格体11的轴向高度(固定机构12运动之前的轴向高度)，但是初始位置与远端固定件13之间的轴向距离不为零，避免将锁定件121设置在网格体11的远端。
为避免网格体11过度变形导致的结构失效，在展开状态下，网格体11的轴向高度不能比径向最大直径小太多，否则会影响支撑性，为此，将初始位置与远端固定件13之间的轴向距离设定为网格体11的轴向高度的0.4倍～0.6倍，如0.4倍、0.5倍或0.6倍。
为了进一步降低对动脉瘤顶的影响，在展开状态下，网格体11的轴向高度优选不大于网格体11的径向最大直径。这样设置后，整个血管内介入治疗装置10的轴向高度小，使得血管内介入治疗装置10的释放长度变短，在降低医生操作难度的同时减少对容易破裂的瘤顶的影响，降低围手术期的破裂风险。另外，网格体11的轴向高度不大于径向最大直径时，使得血管内介入治疗装置10不再需要匹配整个瘤腔的形状，仅需填塞瘤颈部位，并依靠网格体11的外侧面111和瘤壁之间的作用力实现器械的稳定释放，此时可适应于各种形状和大小的动脉瘤，可适用范围更广。
进一步地，在展开状态下，网格体11的轴向高度与径向最大直径之间的比值为1/3～2/3。在展开状态下，网格体11的径向最大直径应根据动脉瘤的尺寸而设定，而为了适应大部分动脉瘤尺寸，可将网格体11在展开状态时的径向最大直径设定为3mm～25mm。
在展开状态下，网格体11可以有各种合适的形状。优选地，在展开状态下，网格体11的外轮廓形状为扁球形状(见图1)、圆柱形状(见图5)或圆台形状(见图8)。当网格体11具有这些形状时，其轴向高度小，释放长度短，在降低医生操作难度的同时减少对容易破裂的瘤顶的影响，降低围手术期的破裂风险，而且不再需要匹配整个瘤腔的形状，仅需要填塞瘤颈部位，并依靠网格体11的外侧面111与瘤壁之间的作用力实现稳定释放，以便适应于各种动脉瘤，各种动脉瘤例如为规则动脉瘤、不规则动脉瘤、宽颈动脉瘤、分
叉部动脉瘤、穿支血管的载瘤动脉等。
如图8所示，当网格体11的外轮廓形状为圆台形状时，网格体11的外顶面112的直径与外底面113的直径的相对大小应根据瘤颈口22的大小而确定，例如，网格体11的外顶面112的直径为外底面113的直径的1.5～3倍，进一步地，外顶面112的直径为外底面113的直径的2倍，以确保外顶面112在牢固卡接瘤壁的同时，外底面113还能够完全覆盖瘤颈口22。
本申请对锁定件121与近端固定件14之间的锁定方式不做限制，一般采用结构简单、操作控制方便、易于实现的锁定方式。
如图4a至图4f所示，在一实施方式中，锁定件121具有单向扣123，单向扣123与近端固定件14的近端侧141扣合连接，也即，直接利用近端固定件14的近端侧141实现对单向扣123的单向锁定。本申请对单向扣123的结构没有限定，只要单向扣123能单向锁定，不能从远端脱出近端固定件14即可，在本实施例中，单向扣123还能够从近端固定件14的远端侧穿过近端固定件14至近端侧141，如单向扣123可一定程度上变形以便于穿过近端固定件14，穿过近端固定件14后回复原状。需要说明的是，单向扣123包括但不仅限于图4b所示的燕尾状锁扣，如本领域技术人员可以理解，还可以是球形锁扣、鱼骨形锁扣、梯形锁扣、锥形锁扣等各种单向扣123。近端固定件14的近端侧141与单向扣123扣合。在填塞状态时，固定机构12向近端牵引血管内介入治疗装置10的远端，直至单向扣123穿过近端固定件14的内孔并锚定，以此使血管内介入治疗装置10稳定覆盖在动脉瘤瘤颈部位。
如图4a和图4b所示，作为一示例，单向扣123为燕尾状锁扣。当单向扣123穿过近端固定件14至近端侧141时，单向扣123的两相对侧翼便被近端固定件14的近端侧141所阻挡，不会轻易脱离近端固定件14。单向扣123的近端侧存在解脱区，该解脱区可以直接设置在锁定件121上，也可以直接设置在牵引件122上。本实施例中，解脱区设置在牵引件122上，即，解脱区设置在牵引件122与单向扣123所连接的部位。解脱区优选为电解脱区，解脱较为方便。
如图4b所示，近端固定件14可为环形套管，环形套管的管壁中设置有多个安装孔，各个编织丝的丝头穿入各个安装孔中固定。近端固定件14的内孔可供单向扣123通过。近端固定件14的内孔可为直孔，如图4b和图4d所示，其他实施例中，近端固定件14的内孔可为锥形孔，如图4f所示。
如图4c和图4d所示，在另一示例中，单向扣123为单侧锁扣，通过牵引件122一侧的梯形锁头与近端固定件14的近端侧141扣合锁死。如图4e和图4f所示，在另一示例中，单向扣123为锥形锁扣，与之匹配的，近端固定件14的内孔为锥形孔，锥形锁扣同样与近端固定件14的近端侧141扣合锁死。
本申请实施例提供的血管内介入治疗装置10在进行手术时，微导管进入病变血管动脉瘤病变处，随后整个血管内介入治疗装置10在微导管内前进，直至其远端到达动脉瘤20的瘤颈口22。保持微导管不动，往前推动推送杆30，使得血管内介入治疗装置10逐渐往动脉瘤20内移动。在此过程中，网格体11会不断地自动膨胀。随着整个血管内介入治疗装置10被推出微导管外，网格体11将会完全被释放在动脉瘤20内。
本申请实施例还提供了一种本申请实施例所述的血管内介入治疗装置10的展开方法，具体包括：
将血管内介入治疗装置10置于微导管的内腔中，使血管内介入治疗装置10处于压缩状态；
利用推送杆30沿微导管的轴向推送血管内介入治疗装置10，直至血管内介入治疗装置10的远端到达动脉瘤20的瘤颈口22；
然后，保持微导管不动，通过推送杆30继续推动血管内介入治疗装置10，使得血管内介入治疗装置10逐渐朝动脉瘤20内移动；
血管内介入治疗装置10被完全推出微导管的远端后，血管内介入治疗装置10便可以从自由扩张状态变形为置于动脉瘤20中的填塞状态；
在填塞状态下，保持微导管和推送杆30不动，然后施力于固定机构12，使固定机构12控制网格体11的远端向近端靠拢，直至固定机构12与网格体
11的近端锁定；
之后，解脱固定机构12位于网格体11的近端外的部分，然后，撤离微导管、推送杆30以及固定机构12位于网格体11的近端外的部分，以此将血管内介入治疗装置10稳定固定在瘤颈部位。
在一示范例中，固定机构12通过单向扣123与近端固定件14锁定，单向扣123与近端固定件14锁定后，电解脱牵引件122位于锁定件121的近端侧的部分，最后撤离微导管、推送杆30和牵引件122被解脱的部分。
接下去，本申请将结合几个具体实施例做进一步描述，且在不冲突的情况下，下述的实施方式及实施方式中的特征可以相互补充或相互组合。
【实施例一】
本申请实施例一提供的血管内介入治疗装置10的结构可参考图1和图2所示。
如图1和图2所示，本申请实施例一提供的血管内介入治疗装置10包括网格体11和固定机构12。网格体11优选由编织丝编织而成，并可以降解。固定机构12包括锁定件121和牵引件122。网格体11的远端由远端固定件13束缚固定。网格体11的近端由近端固定件14束缚固定。牵引件122的一部分经由网格体11的近端穿入网格体11中，并使牵引件122的一端与远端固定件13连接。如图3所示，牵引件122的另一部分从网格体11的近端伸出，并进一步穿过推送杆30的内腔延伸至推送杆30的近端。锁定件121设置在网格体11中，并固定在牵引件122上，牵引件122可穿过锁定件121并与之连接。操作者可以在体外操控牵引件122的另一端，实现对固定机构12的控制。锁定件121可以具有燕尾状的单向扣123，单向扣123的两侧翼相对布置，形成类似于V型结构。牵引件122可以在单向扣123的近端侧进行电解脱。
如图1和图3所示，在展开状态下，网格体11的外轮廓为扁球状，此时，网格体11的轴向高度可设置为其径向最大直径的0.5倍，且单向扣123与远端固定件13之间的轴向距离为网格体11的轴向高度的0.4倍。由于扁球状的
网格体11的轴向高度小，使得血管内介入治疗装置10的释放长度变短，在降低医生操作难度的同时减少对容易破裂的瘤顶的影响，降低围手术期的破裂风险。
如图4所示，在展开状态下，拉动固定机构12，使固定机构12朝近端方向运动，此时，图3所示的填塞状态下的扁球状的网格体11的轴向高度被进一步减小，此过程中，不仅加大了网格体11的外侧面111和瘤壁之间的作用力，增加了血管内介入治疗装置10在瘤颈部位的稳定性，确保血管内介入治疗装置10治疗动脉瘤的长期有效性，而且使网格体11与瘤壁之间的贴靠性更好，同时能够更有效的覆盖瘤颈口22。进而利用单向扣123与近端固定件14之间的锁定，便可限制网格体11的轴向高度，使网格体11保持在当前的填塞状态。
还需说明的是，本申请实施例一提供的血管内介入治疗装置10在展开状态时为扁球形状，在释放过程中不会接触容易破裂的瘤顶部位，降低了手术中动脉瘤破裂的风险，具体可参见图3。
【实施例二】
本申请实施例二提供的血管内介入治疗装置10的结构可参考图5所示。如图5所示，本申请实施例二提供的血管内介入治疗装置10包括网格体11和固定机构12。网格体11优选由编织丝编织而成，并可以降解。固定机构12包括锁定件121和牵引件122。网格体11的远端由远端固定件13束缚固定。网格体11的近端由近端固定件14束缚固定。牵引件122的一部分经由网格体11的近端穿入网格体11中，并使牵引件122的一端与远端固定件13连接。如图6所示，牵引件122的另一部分从网格体11的近端伸出，并进一步穿过推送杆30的内腔延伸至推送杆30的近端。锁定件121设置在网格体11中，并固定在牵引件122上，牵引件122可穿过锁定件121并与之连接。操作者可以在体外操控牵引件122的另一端，实现对固定机构12的控制。锁定件121可以具有燕尾状的单向扣123，两侧翼相对布置，形成类似于V型
结构。牵引件122可以在单向扣123的近端侧进行电解脱。
如图5和图6所示，在展开状态下，网格体11的外轮廓为圆柱状，此时，网格体11的轴向高度可设置为其径向最大直径D的0.4倍，且单向扣123与远端固定件13之间的轴向距离为网格体11的轴向高度的0.5倍。同理，由于圆柱状的网格体11的轴向高度小，使得血管内介入治疗装置10的释放长度变短，在降低医生操作难度的同时减少对容易破裂的瘤顶的影响，降低围手术期的破裂风险。
如图7所示，在展开状态下，拉动固定机构12，使固定机构12朝近端方向运动，此时，图6所示的填塞状态下的圆柱状的网格体11的轴向高度被进一步减小，不仅加大了网格体11的外侧面111和瘤壁之间的作用力，增加了血管内介入治疗装置10在瘤颈部位的稳定性，确保血管内介入治疗装置10治疗动脉瘤的长期有效性，而且使网格体11与瘤壁之间的贴靠性更好，同时能够更有效的覆盖瘤颈口22。此外，当单向扣123与近端固定件14锁定后，便可限制网格体11的轴向高度，使网格体11保持在当前的填塞状态。
需补充说明的是，本申请实施例二提供的血管内介入治疗装置10在展开状态时为圆柱形状，在释放过程中不会接触容易破裂的瘤顶部位，降低手术中动脉瘤破裂的风险，具体可参见图6。此外，相比于实施例一中的扁球形状，圆柱形状的径向支撑力更好，能增加血管内介入治疗装置10的外侧面111和瘤壁之间的作用力，提高血管内介入治疗装置10在覆盖瘤颈口22的稳定性。
【实施例三】
本申请实施例三提供的血管内介入治疗装置10的结构可参考图8所示。如图8所示，本申请实施例三提供的血管内介入治疗装置10包括网格体11和固定机构12。网格体11优选由编织丝编织而成，并可以降解。固定机构12包括锁定件121和牵引件122。网格体11的远端由远端固定件13束缚固定。网格体11的近端由近端固定件14束缚固定。牵引件122的一部分经由网格体11的近端穿入网格体11中，并使牵引件122的一端与远端固定件13
连接。如图9所示，牵引件122的另一部分从网格体11的近端伸出，并进一步穿过推送杆30的内腔延伸至推送杆30的近端。锁定件121设置在网格体11中，并固定在牵引件122上，牵引件122可穿过锁定件121并与之连接。操作者可以在体外操控牵引件122的另一端，实现对固定机构12的控制。锁定件121可以具有燕尾状的单向扣123，两侧翼相对布置，形成类似于V型结构。牵引件122可以在单向扣123的近端侧进行电解脱。
如图8和图9所示，在展开状态下，网格体11的外轮廓为圆台状，此时，网格体11的轴向高度可设置为其径向最大直径D的0.6倍，且单向扣123与远端固定件13之间的轴向距离为网格体11的轴向高度的0.6倍。圆台状的网格体11的轴向高度也小，使得血管内介入治疗装置10的释放长度变短，在降低医生操作难度的同时减少对容易破裂的瘤顶的影响，降低围手术期的破裂风险。此外，在展开状态下，圆台形状的网格体11的外顶面112的直径为外底面113的直径的2倍，便于网格体11更好的与瘤壁卡接，并确保覆盖瘤颈口22。另外，鉴于动脉瘤20的瘤颈口22小于瘤腔的最大直径，因此网格体11展开后的圆台形外轮廓更容易卡紧在动脉瘤20内，使得单向扣123向近端方向下拉的长度也可以更短，见图9所示。
如图10所示，在展开状态下，拉动固定机构12，使固定机构12朝近端方向运动，此时，图9所示的填塞状态下的圆台形状的网格体11的轴向高度被进一步减小，不但加大了网格体11的外侧面111和瘤壁之间的作用力，增加了血管内介入治疗装置10在瘤颈部位的稳定性，确保了血管内介入治疗装置10治疗动脉瘤的长期有效性，而且使网格体11与瘤壁之间的贴靠性更好，同时能够更有效的覆盖瘤颈口22。继而当单向扣123与近端固定件14锁定后，网格体11的轴向高度也就便限制不再变化，使网格体11保持在当前的填塞状态。
同样的，本申请实施例三提供的血管内介入治疗装置10展开状态下为圆台形状，在释放过程中不会接触容易破裂的瘤顶部位，降低手术中动脉瘤破裂的风险。此外，圆台形的径向支撑力更好，能增加血管内介入治疗装置10
的外侧面111和瘤壁之间的作用力，提高血管内介入治疗装置10在覆盖瘤颈口时的稳定性。
需要特别说明的是，本发明中，网格体11在展开时外轮廓也可以不是扁球形状、圆柱形状或圆台形状。
综上所述，本发明提供的血管内介入治疗装置兼顾了柔顺性和长期填塞稳定性，确保了动脉瘤的填塞效果，此外仅填塞部分瘤腔，在动脉瘤内释放长度短，可降低手术过程中医生的操作难度，减少手术时间，且完全位于动脉瘤内，可避免双重抗血小板药物的使用，进一步通过外侧面和瘤壁之间的过盈作用实现稳定填塞，而无需填满整个瘤腔，能够适应更多的动脉瘤形状，扩大适用范围。进一步，当网格体在展开状态时的径向最大直径大于轴向高度，可减少对瘤顶的影响，降低破裂风险。进一步，动脉瘤愈合后，网格体可逐步降解，减少占位效应的发生，并且还解决了可降解网格体难以回复至初始扩张状态而无法应用在动脉瘤填塞的问题。
需要说明的是，本说明书中各个实施例采用递进的方式描述，每个实施例重点说明的都是与其他实施例的不同之处，各个实施例之间相同相似部分互相参见即可。对于实施例公开的***而言，由于与实施例公开的方法相对应，所以描述的比较简单，相关之处参见方法部分说明即可。
还需要说明的是，虽然本发明已以较佳实施例披露如上，然而上述实施例并非用以限定本发明。对于任何熟悉本领域的技术人员而言，在不脱离本发明技术方案范围情况下，都可利用上述揭示的技术内容对本发明技术方案作出许多可能的变动和修饰，或修改为等同变化的等效实施例。因此，凡是未脱离本发明技术方案的内容，依据本发明的技术实质对以上实施例所做的任何简单修改、等同变化及修饰，均仍属于本发明技术方案保护的范围。
还应当理解的是，除非特别说明或者指出，否则说明书中的术语“第一”、“第二”、“第三”等描述仅仅用于区分说明书中的各个组件、元素、步骤等，而不是用于表示各个组件、元素、步骤之间的逻辑关系或者顺序关系等。
此外还应该认识到，此处描述的术语仅仅用来描述特定实施例，而不是
用来限制本发明的范围。必须注意的是，此处的以及所附权利要求中使用的单数形式“一个”和“一种”包括复数基准，除非上下文明确表示相反意思。例如，对“一个步骤”或“一个装置”的引述意味着对一个或多个步骤或装置的引述，并且可能包括次级步骤以及次级装置。应该以最广义的含义来理解使用的所有连词。以及，词语“或”应该被理解为具有逻辑“或”的定义，而不是逻辑“异或”的定义，除非上下文明确表示相反意思。此外，本发明实施例中的方法和/或设备的实现可包括手动、自动或组合地执行所选任务。
Claims (16)
- 一种血管内介入治疗装置，具有展开状态和压缩状态，其特征在于，包括网格体和固定机构；至少部分所述固定机构置于所述网格体中，并使所述固定机构的一端与所述网格体的远端连接；在所述展开状态下，所述固定机构能够受力运动，以驱使所述网格体的远端沿所述网格体的轴向运动，进而调整所述网格体的轴向高度，且运动后的所述固定机构能够与所述网格体的近端锁定，以限制所述网格体的轴向高度，并使得所述血管内介入治疗装置仅填塞目标腔体的部分空间，以避开所述目标腔体的腔顶，并同时覆盖所述目标腔体的颈口。
- 如权利要求1所述的血管内介入治疗装置，其特征在于，所述固定机构包括牵引件和锁定件；至少部分所述牵引件经由所述网格体的近端置于所述网格体中，且所述牵引件的一端与所述网格体的远端连接；所述锁定件与所述牵引件连接，并置于所述网格体中；在所述展开状态下，当所述牵引件和/或所述锁定件受力运动时，所述固定机构通过所述牵引件驱使所述网格体的远端沿轴向运动，直至运动后的所述锁定件与所述网格体的近端锁定。
- 如权利要求2所述的血管内介入治疗装置，其特征在于，所述牵引件的远端部分经由所述网格体的近端置于所述网格体中，且所述牵引件的所述一端与所述网格体的远端连接；所述牵引件的近端部分从所述网格体的近端伸出，以使所述牵引件的另一端暴露在所述网格体外；所述锁定件的近端侧设有解脱区；所述锁定件与所述网格体的近端锁定后，所述解脱区用于控制所述近端部分和所述远端部分之间的解脱。
- 如权利要求2或3所述的血管内介入治疗装置，其特征在于，还包括近端固定件和远端固定件，所述网格体的近端由所述近端固定件束缚固定，所述网格体的远端由所述远端固定件束缚固定，所述牵引件的所述一端与所述远端固定件连接，所述锁定件用于与所述近端固定件锁定。
- 如权利要求4所述的血管内介入治疗装置，其特征在于，在所述展开状 态下，所述锁定件具有初始位置和锁定位置；在所述初始位置，所述锁定件与所述近端固定件分离；在所述锁定位置，所述锁定件与所述近端固定件锁定；其中，所述初始位置与所述远端固定件之间的轴向距离小于所述网格体的轴向高度。
- 如权利要求5所述的血管内介入治疗装置，其特征在于，在所述展开状态下，所述初始位置与所述远端固定件之间的轴向距离为所述网格体的轴向高度的0.4倍～0.6倍。
- 如权利要求4所述的血管内介入治疗装置，其特征在于，所述锁定件具有单向扣，所述单向扣与所述近端固定件的近端侧扣合连接。
- 如权利要求1-3任一项所述的血管内介入治疗装置，其特征在于，在所述展开状态下，所述网格体的径向最大直径大于所述目标腔体对应位置处的直径，以通过所述网格体与所述目标腔体的腔壁之间的作用力固定所述血管内介入治疗装置。
- 如权利要求8所述的血管内介入治疗装置，其特征在于，在所述展开状态下，所述网格体的轴向高度不大于所述网格体的径向最大直径。
- 如权利要求8所述的血管内介入治疗装置，其特征在于，在所述展开状态下，所述网格体的轴向高度与所述网格体的径向最大直径之间的比值为1/3～2/3。
- 如权利要求8所述的血管内介入治疗装置，其特征在于，在所述展开状态下，所述网格体的径向最大直径为3mm～25mm。
- 如权利要求8所述的血管内介入治疗装置，其特征在于，在所述展开状态下，所述网格体的外轮廓形状为扁球形状、圆柱形状或圆台形状。
- 如权利要求12所述的血管内介入治疗装置，其特征在于，当所述网格体的外轮廓形状为圆台形状时，所述网格体的外顶面的直径为外底面直径的1.5～3倍。
- 如权利要求1-3任一项所述的血管内介入治疗装置，其特征在于，所述网格体由生物可降解材料制备而成。
- 如权利要求14所述的血管内介入治疗装置，其特征在于，制备所述网格体的生物可降解材料为以下材料的一种或多种组合：聚对二氧环己酮、丙交酯-ε-己内酯共聚物、聚乳酸、聚乳酸-羟基乙酸共聚物及其混合物。
- 如权利要求1-3任一项所述的血管内介入治疗装置，其特征在于，所述网格体为编织结构，所述编织结构中的编织丝的丝径为0.001in～0.003in，所述编织丝的数目为48根～144根。
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| US20060167494A1 (en) * | 2005-01-21 | 2006-07-27 | Loubert Suddaby | Aneurysm repair method and apparatus |
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