CN114788720A - Vascular occlusion device, intracranial aneurysm occlusion device and using method thereof - Google Patents

Abstract

The invention discloses a vascular occlusion device, intracranial aneurysm occlusion equipment and a using method thereof, and relates to the technical field of medical instruments, wherein a first lumen is formed through a first outer tube, and at least one end of the first lumen is communicated with the external environment to form a first lumen opening so that a filling medium can flow out of or into the first lumen through the first lumen opening; the balloon cavity of the balloon is communicated with the first lumen, and the surface of the balloon is provided with a supporting part for carrying the occlusion part; a guide channel is formed in the inner tube; the second outer tube is provided with a hollow second tube cavity, the protection component at least partially covers the supporting part, and the second tube cavity provides a space for accommodating the protection component. Make protection component cladding in the periphery of sacculus supporting part under initial condition to the effect of carrying occlusion member and the sacculus body of putting on the supporting part and playing the protection improves aneurysm shutoff operation's success rate, greatly reduced operation risk and postoperative lead incomplete rate and fatality rate.

Description

Vascular occlusion device, intracranial aneurysm occlusion device and using method thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to a vascular occlusion device, intracranial aneurysm occlusion equipment and a using method thereof.

Background

The walls of the vascular system, and in particular the arterial walls, may develop a pathological dilatation called aneurysm, a permanent swelling disease that occurs due to a weak arterial wall, commonly observed as a saccular protrusion of the arterial wall, with a weak sac wall and a concomitant tendency to rupture, often aggravated by hypertension. Aneurysms can be found in different parts of the body, the most common of which is currently the abdominal aneurysm, the cerebral aneurysm.

Intracranial aneurysms, a neoplastic protrusion of the arterial wall resulting from localized abnormal enlargement of the cerebral arteries, are a common, very dangerous condition in intracranial vascular pathologies, the mere presence of an aneurysm does not necessarily endanger life, but if it ruptures in the brain, it can have serious health consequences, such as stroke, even death.

With the development of neuro-interventional materials and techniques, interventional embolization has become the main trend in intracranial aneurysm treatment, which is mainly to occlude aneurysm cavity by endovascular procedures using materials such as removable coils, liquid glue or intratumoral embolization devices; or the aneurysm-carrying artery is reconstructed through an intracranial intravascular stent, a blood flow guiding device (FD), a covered stent and the like so as to improve the local hemodynamics of the aneurysm and finally realize the purpose of aneurysm occlusion.

However, in the process of moving the surgical device for aneurysm surgery to the parent artery, the difficulty of the operation of the portion for performing the surgery is high, and the portion is not protected too much, so that the device portion for performing the occlusion, filling and the like of the aneurysm risks to intervene in the artery tissue prematurely, and the surgical failure is caused, and the risk of causing complications, the risk of failure of the surgical operation, and the disability rate and the fatality rate after the surgical operation are high.

Disclosure of Invention

The embodiment of the invention aims to: before the device and the equipment carry out the occlusion operation on the aneurysm, a balloon carrying an occlusion piece is covered and protected by a protection component, so that the problem that the operation device intervenes in the artery tissue of a human body prematurely is solved.

In order to achieve the purpose, the invention adopts the following technical scheme:

in a first aspect, there is provided a vaso-occlusive device comprising:

the first outer tube is provided with a hollow first tube cavity, the first tube cavity provides a flow channel for filling medium to flow, and at least one end of the first tube cavity is communicated with the external environment to form a first cavity opening so that the filling medium can flow out of or into the first tube cavity through the first cavity opening;

a balloon configured as a hollow balloon body radially compressible and radially expandable under force, the balloon lumen communicating with the first lumen, the balloon surface providing a support for carrying an occluding component;

the guide channel is formed in the inner tube, and the guide channel provides a space for guiding a guide wire to move through;

the second outer tube is provided with a hollow second tube cavity, and one end, close to the first cavity opening, of the second tube cavity is communicated with the external environment to form a second cavity opening;

the protection component at least partially covers the support part, and the second tube cavity provides a space for accommodating the protection component, so that the protection component can be separated from the support part and enter the second tube cavity under the action of force.

As an alternative embodiment, the inner tube is threaded to the first lumen such that the inner wall of the first outer tube and the outer wall of the inner tube form the flow passage.

As an alternative embodiment, the inner tube is provided with at least two development rings at intervals, and the development rings are at least partially overlapped with the projection of the balloon on the same axial section of the balloon.

As an alternative embodiment, one end of the inner tube extends out of the first outer tube from the first orifice;

the first end of the balloon is connected with the first outer tube, and the second end of the balloon is connected with one end of the inner tube extending out of the first outer tube.

As an alternative embodiment, the first outer tube and the inner tube form a catheter assembly, and the balloon is sleeved on the catheter assembly along the length direction;

the two opposite ends of the balloon are respectively connected with the first outer tube and the inner tube in a sealing manner.

As an alternative embodiment, the first outer tube is threaded to the second lumen such that an inner wall of the second outer tube and an outer wall of the first outer tube form a space for accommodating the protective assembly.

As an alternative embodiment, the protection assembly comprises:

a withdrawal guidewire movably threaded through the second lumen, the withdrawal guidewire extending at least partially out of the second outer tube through the second lumen;

the supporting body is connected with the withdrawing guide wire and extends to the outside of the balloon, and a coating is arranged on the supporting body and arranged along the extending direction of the supporting body so that the supporting body is coated on the outer peripheral surface of the supporting part through the coating;

the withdrawn guide wire can drive the support body and the covering film to be unfolded along the extending direction of the support body and be contained in the second tube cavity.

As an optional embodiment, the support body is made of nitinol.

As an optional embodiment, the material of the covering film includes one or a combination of more of polyurethane, polyethylene, and polypropylene.

In a second aspect, there is provided a vaso-occlusive device comprising:

the inner pipe is internally provided with mutually independent guide channels and flow channels for providing the flow of the filling medium, so that the filling medium can flow out of or into the flow channels;

a balloon configured as a hollow balloon that is radially compressible and radially expandable under force, the balloon lumen communicating with the flow channel, the balloon surface providing a buttress for placement of an occlusion;

the second outer tube is provided with a hollow second tube cavity, and one end, close to the flow channel, of the second tube cavity is communicated with the external environment to form a second cavity opening;

the protective assembly at least partially covers the supporting part, and the second tube cavity provides a space for accommodating the protective assembly, so that the protective assembly can be separated from the supporting part and enter the second tube cavity under the action of force.

In a third aspect, there is provided an intracranial aneurysm occlusion device comprising:

a vaso-occlusive device as described above;

an occlusion member is mounted on the support portion.

As an alternative embodiment, the occlusion member is a sheet structure, and the occlusion member comprises, in the order from outside to inside, stacked:

a hydrophobic layer configured to have a blood-repelling fluid structure layer;

the adhesive layer is provided with a medicine and adheres to the vascular tissue of a human body on one side close to the hydrophobic layer;

an anti-fouling layer for reducing biofouling and post-operative inflammation.

As an alternative embodiment, the balloon and the occlusion element are of a collapsible construction such that the occlusion element can be collapsed along with the balloon for stowage in the protective assembly.

In a fourth aspect, there is provided a method of use of an intracranial aneurysm occlusion device comprising an intracranial aneurysm occlusion device as described above, the method of use comprising:

s10, placing a guide wire into the intracranial common artery, and penetrating the guide wire placed into the intracranial common artery to the position of the parent artery;

s20, the first outer tube and the second outer tube enter the parent artery along the guide wire along the inner tube, and the supporting part is determined to be in the lesion position;

s30, controlling the protective component to withdraw the second lumen and disengage the supporting part, so that the saccule and the obturator loaded on the supporting part are exposed in the parent artery and face the lesion position;

s40, injecting a filling medium into a cavity of the balloon through the flow channel so as to radially expand the balloon and drive the occlusion part to approach the surface of the artery tissue;

s50, continuously injecting filling medium into the balloon cavity of the balloon, and enabling the occlusion member to abut against and adhere to the surface of the artery tissue to complete the occlusion of the aneurysm cavity.

The invention has the beneficial effects that: the vaso-occlusive device provides a flow path through the first outer or inner tube so that a filling medium can be injected into the balloon through the flow path, and the balloon surface provides a support for the occluding component to rest on.

In the application of intracranial aneurysm occlusion equipment, the protection subassembly is in the initial state cladding in the periphery of sacculus supporting part to play the effect of protection to the obturator of carrying on the supporting part and sacculus body, avoid sacculus and obturator to intervene in advance on the tissue surface of other blood vessels along the process that guides the seal wire and remove to the parent artery. After the sacculus got into and carries the tumor artery, withdraw to the second lumen through control protection subassembly, make the protection subassembly break away from the protection to sacculus and occlusive member, make sacculus and occlusive member expose in carrying the tumor artery, the subsequent operation of being convenient for to improve the success rate of aneurysm shutoff operation, also can avoid the patient to arouse the risk of complication at operation in-process and postoperative, greatly reduced operation risk and postoperative lead incomplete rate and fatality rate.

Drawings

The invention is explained in more detail below with reference to the figures and examples.

FIG. 1 is a schematic view of the overall structure of an intracranial aneurysm occlusion device according to an embodiment of the invention;

FIG. 2 is a schematic cross-sectional view of an intracranial aneurysm occlusion device, in accordance with an embodiment of the invention;

FIG. 3 is an enlarged view of portion A of FIG. 2;

FIG. 4 is a schematic cross-sectional view A-A of FIG. 2;

FIG. 5 is a schematic illustration of an occluding component according to an embodiment of the present invention;

FIG. 6 is a schematic structural diagram of a protection component according to an embodiment of the present invention;

FIG. 7 is a schematic cross-sectional view of a protection assembly according to an embodiment of the present invention;

FIG. 8 is a cross-sectional view of a support according to an embodiment of the present invention;

FIG. 9 is a second cross-sectional view of the support according to the second embodiment of the present invention;

fig. 10 is a method of using an intracranial aneurysm occlusion device, according to an embodiment of the invention.

In the figure: 10. a first outer tube; 11. a first lumen; 12. a first port; 20. a balloon; 21. an occluding member; 211. a hydrophobic layer; 212. an adhesive layer; 213. an antifouling layer; 30. an inner tube; 31. a guide channel; 32. a developing ring; 33. a tip; 40. a second outer tube; 41. a second lumen; 42. a second port; 50. a protection component; 51. withdrawing the guide wire; 52. a support body; 521. a support wire; 522. coating a film; 60. a catheter hub.

Detailed Description

In order to make the technical problems solved, technical solutions adopted and technical effects achieved by the present invention clearer, the following describes in further detail the technical solutions of the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In the description of the present invention, unless otherwise expressly specified or limited, the terms "connected," "connected," and "fixed" are to be construed broadly, e.g., as meaning permanently connected, removably connected, or integral to one another; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or may be connected through the use of two elements or the interaction of two elements. The specific meanings of the above terms in the present invention can be understood in a specific case to those of ordinary skill in the art.

In the present invention, unless expressly stated or limited otherwise, the recitation of a first feature "on" or "under" a second feature may include the recitation of the first and second features being in direct contact, and may also include the recitation that the first and second features are not in direct contact, but are in contact via another feature between them. Also, the first feature "on," "above" and "over" the second feature may include the first feature being directly above and obliquely above the second feature, or simply indicating that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature includes the first feature being directly under and obliquely below the second feature, or simply meaning that the first feature is at a lesser elevation than the second feature.

The embodiment provides a vascular occlusion device, which can be applied to intracranial aneurysm occlusion equipment and aims to improve the success rate of aneurysm occlusion surgery so as to reduce disability rate and fatality rate of patients in and after the surgery.

The surgical objective of this embodiment is to take the intracranial aneurysm as an example, and in the case of intracranial aneurysms (cerebral aneurysms), the most common of which is known as saccular aneurysms (saccular aneurysms), which are commonly found at the bifurcation of a blood vessel, generally by the flow of blood to the thinner walls of the vessel and by the shear stresses created by the flow of blood, and once the aneurysm has formed, fluctuations in the flow of blood in the aneurysm are critical because they can cause a shock to the walls of the aneurysm, and in order to accommodate the constant flow of blood into the aneurysm, the walls of the lumen continue to expand, presenting a significant risk of rupture, which aids in the development and eventual rupture. Aneurysms are commonly accomplished by the introduction of materials (releasable coils, liquid gels, intratumoral embolization devices, intracranial vascular stents, blood flow directing devices, covered stents, etc.) into the parent artery or lumen to effect the reconstruction of the parent artery or occlusion of the aneurysm cavity.

As mentioned in many of the above-mentioned articles based on the origin, formation and rupture of cerebral aneurysms, it is clear that the goal of aneurysm treatment is to reduce the risk of rupture of the aneurysm and thus reduce the consequences of subarachnoid hemorrhage. It should be noted that, however, since the portion of the surgical device for carrying the intervention material is generally exposed to the external environment, during the operation, the portion of the surgical device for carrying the intervention material is likely to interfere with the wall of the blood vessel during the movement of the portion along the blood vessel, so that the intervention material is not moved to the parent artery, i.e. passively intervened to the wall of other blood vessel, so that the intervention material fails, and the operation fails, and during the movement, the intervention material is likely to interfere with the wall of the blood vessel, so that complications are likely to occur, and the risk of the operation is increased, the following scheme is proposed in the present embodiment to prevent the intervention material from being intervened in advance.

Both the focal position and the lesion position described in the present embodiment refer to the position of an aneurysm in a parent artery.

As shown in fig. 1 to 4, the vaso-occlusive device comprises a first outer tube 10, which is tubular in configuration and has a substantially circular outer peripheral cross-section in order to adapt to the cross-sectional configuration of a human blood vessel. The first outer tube 10 is provided with a hollow first tube cavity 11 along the length direction thereof, the first tube cavity 11 provides a flow channel for the flow of the filling medium, at least one end of the first tube cavity 11 is communicated with the external environment to form a first cavity opening 12, so that the filling medium can flow out or flow into the first tube cavity 11 through the first cavity opening 12, generally speaking, both opposite ends of the first tube cavity 11 are communicated with the external environment, and thus, the filling medium can be injected into the first tube cavity 11 from one end of the first outer tube 10, so that the filling medium can flow along the flow channel direction, and finally flow out from the first cavity opening 12, thereby completing the injection operation of the filling medium.

It is understood that the filling medium of the present embodiment includes, but is not limited to, contrast agent, saline, and gas.

In order to allow the intervention material to smoothly intervene in the artery tissue after reaching the lesion site, the vaso-occlusive device of the present embodiment further includes a balloon 20, and the balloon 20 is a hollow balloon that can be compressed and expanded in the radial direction by a force, and here, the cross-sectional shape of the outer periphery of the vaso-occlusive device is a circle.

Further describing, the lumen of the balloon 20 communicates with the first lumen 11, so that in practical applications of the vaso-occlusive device, a filling medium can be injected into the balloon 20 through the first lumen 11, and, as the filling medium is injected into the cavity of the balloon 20, the balloon 20 is gradually inflated and deployed in the radial direction, the outer surface of the balloon 20 is provided with a supporting part for carrying the occlusion member 21, and during the actual operation, the supporting part moves along the direction close to the vessel closure along with the radial expansion of the balloon 20, thereby enabling the occluding component 21 carried on the support portion to abut against the tissue surface of the blood vessel, eventually adhering to the blood vessel tissue, and, the balloon 20 is radially compressed when the filling medium re-flows back into the first lumen 11, thereby moving in a direction away from the vascular tissue surface together with the support portion at a position close to the vascular tissue surface, disengaging the occluding member 21 which has adhered to the vascular tissue. In particular, the balloon 20 may be made of a material having contractility and elasticity, in particular, the elastic material may be silicone, and in an initial state, the balloon 20 is in a compressed position, so that when the vaso-occlusive device is in a blood vessel, the surface of the balloon 20 is as far away from the tissue surface of the blood vessel as possible, thereby reducing the risk of interference between the occlusion member 21 on the surface thereof and the blood vessel. It is understood that the balloon 20 may be stored on the vaso-occlusive device in a folded manner, and the folded balloon 20 may be used in combination with the folding technique of the balloon 20 to make the balloon 20 more space-saving in the compressed position, and the balloon 20 may be gradually unfolded from the compressed position to the expanded position when the filling medium is injected into the balloon cavity, and the folded balloon 20 and the folding technique thereof are conventional in the art and will not be described in detail herein.

In order to guide the balloon 20 and the obturator 21 in the blood vessel of the human body, the vaso-occlusive device is further provided with an inner tube 30, the inner tube 30 is a hollow structure so as to form a guide channel 31 in the inner tube, the guide channel 31 provides a space for a guide wire to move through, in the practical application of the vaso-occlusive device, a guide wire which can move relative to the inner tube 30 can be connected in the guide channel 31 in a penetrating way, the guide wire can be placed in the blood vessel of the human body and can move to a lesion position, so that the inner tube 30 plays a role of guiding the moving direction after being subsequently placed in the human body, in order to enable the first outer tube 10 to move to the lesion position together when the inner tube 30 moves along the guide wire, the first outer tube 10 is generally fixed relative to the inner tube 30, and the first lumen 11 is arranged to be a structure which is parallel to the guide channel 31, so as to improve the positioning accuracy of the balloon 20 after moving to the lesion position, of course, this embodiment is merely one preferred embodiment for providing the present vaso-occlusive device, and is not intended to be limiting in any way.

In order to provide a safe and accurate guiding function for the guide wire, the guide wire may be a stainless steel and nickel titanium mixed structure, which provides a soft and non-destructive tip 33, and simultaneously maximizes the push-pull control and torque response during guiding, and the distal end of the guide wire may be provided with a smooth hydrophilic coating to enhance its lubricity and ensure that the guide wire can smoothly pass through the inner tube 30. During the operation, the guide wire is inserted into the inner tube 30 through the introduction tool with its tip 33 and further advanced, controlled by the torque device, to select the appropriate vessel position.

As shown in fig. 6-9, in order to protect the balloon 20 and the occluding member 21 mounted on the balloon 20, the vaso-occlusive device further includes a second outer tube 40, the second outer tube 40 is a hollow structure and has a second lumen 41 formed therein, and one end of the second lumen 41 close to the first lumen 12 communicates with the external environment to form a second lumen 42, it can be understood that, in order to realize that the second outer tube 40 moves synchronously with the first outer tube 10 in the process of moving the first outer tube 10 in the blood vessel, the second outer tube 40 is preferably fixed relatively to the first outer tube 10, a supporting portion of the balloon 20 is covered with a protective component 50, the protective component 50 can protect the balloon 20 and the occluding member 21, so that when the vaso-occlusive device is mounted in the blood vessel, the occluding member 21, the balloon 20 and the closed tissue of the blood vessel are isolated from interfering contact with each other, one end of the protective component 50 is movably disposed in the second lumen 41, the other end of the protection component 50 is at least partially covered on the supporting part, the protection component 50 of the embodiment is covered on the outer circumferential surface of the balloon 20 to protect the whole balloon 20, the second lumen 41 provides a space for accommodating the protection component 50, the protection component 50 is in an initial state of covering the balloon 20 in the process of operation implementation, the balloon 20 and the occlusion part 21 can be protected, the device is convenient to store and transport, the first outer tube 10 and the second outer tube 40 are relatively fixed, the second outer tube 40 connected with the protection component 50 can move together with the first outer tube 10 and the inner tube 30, the balloon 20 and the occlusion part 21 are protected in the process of moving the vascular occlusion device to the lesion position, after the balloon 20 moves to the lesion position, the protection component 50 can be controlled to withdraw into the second lumen 41, and meanwhile, the protection component 50 is separated from the protection of the balloon 20 and the occlusion part 21, the balloon 20 and the occlusion 21 are exposed to the parent vessel for subsequent injection of a filling medium.

Preferably, the end of the protection component 50 is blunt, so as to avoid accidental injury of the protection component 50 and other organs of the human body.

By implementing the technical scheme, when the blood vessel occlusion device is applied to an intracranial aneurysm occlusion device, the protective component 50 can be coated on the periphery of the balloon 20 in an initial state so as to protect the occlusion piece 21 loaded on the supporting part and the balloon 20 body, isolate the tissue of the blood vessel wall from the contact of the balloon 20 and the occlusion piece 21, and avoid the early intervention of the balloon 20 and the occlusion piece 21 on the tissue surface of other blood vessels in the process of moving to a parent artery along the guide wire. After sacculus 20 got into the parent artery, withdraw to in the second lumen 41 through control protection subassembly 50, make protection subassembly 50 break away from the protection to sacculus 20 and closure 21, make sacculus 20 and closure 21 expose in the parent artery, the subsequent operation of being convenient for, thereby improve the success rate of aneurysm shutoff operation, also can avoid the patient to arouse the risk of complication at operation in-process and postoperative, greatly reduced operation risk and postoperative lead to disability rate and lethality rate.

In order to allow the vaso-occlusive device to smoothly pass to the lesion site along the guide wire, it is preferable that the first outer tube 10, the second outer tube 40, and the inner tube 30 are formed as flexible bodies in the present embodiment so as to pass to the lesion site between organs in the human body in accordance with the internal structure of the human body.

In order to improve the integrity of the blood vessel occlusion device, the present embodiment arranges the inner tube 30 so as to be inserted into the first outer tube 10 and to be disposed in the first lumen 11, so that the above-described flow path can be formed between the inner wall of the first outer tube 10 and the outer wall of the inner tube 30. In addition, the embodiment of the sleeve structure can avoid the situation that the pipe body structures are arranged side by side, so that the section shape of the blood vessel blocking device can be better grasped, the section shape of the blood vessel blocking device can be determined by the outer peripheral surface structure of the first outer pipe 10, the requirement of the processing precision of the whole device can be reduced to a certain extent, and the outer diameter size of the device can also be reduced to the largest extent.

As shown in fig. 2 to 3, in order to mark the position of the balloon 20 when the vaso-occlusive device is inside the human body, at least two developing rings 32 are disposed at intervals on the inner tube 30, specifically, the developing rings 32 may be sleeved on the outer circumferential wall of the inner tube 30 or embedded in the guide channel 31 of the inner tube 30, of course, the developing rings 32 may also be processed as a part of the inner tube 30, so that the outer side and the inner side of the developing rings 32 are flush with the outer side and the inner side of the inner tube 30, respectively.

The developing ring 32 may be made of any one of platinum, platinum-tungsten alloy, platinum-iridium alloy, and silver

Specifically, the developing rings 32 and the projection of the balloon 20 on the same axial section of the balloon 20 at least partially coincide, it can be understood that the two developing rings 32 are disposed at intervals between two opposite ends of the balloon, preferably, the two developing rings 32 are disposed at one end of the balloon 20 close to the flow channel and one end of the balloon 20 far from the flow channel, respectively, and when the blood vessel occlusion device is located inside the blood vessel, the developing rings 32 are a component that does not project a line, so that the effect of influencing observation can be enhanced on an image display device of a medical instrument, thereby determining the length distance of the balloon 20 inside the blood vessel, further confirming and determining the position of the occlusion member 21 loaded on the balloon 20, and facilitating the subsequent aneurysm occlusion operation.

As shown in fig. 2 to 4, here, in order to further improve the integrity of the vasoocclusive device, the installation space of the device is fully utilized to reduce the overall volume of the device, and the inner tube 30 extends from the first lumen 12 out of the first outer tube 10 at one end, and the length of the inner tube 30 is greater than that of the first outer tube 10 based on the inner tube 30 being flush with one end of the first outer tube 10, so that the inner tube 30 can extend from the first lumen 12 out of the first outer tube 10, and the inner tube 30 can extend out of the first outer tube 10 to provide the installation position of the balloon 20.

The balloon 20 is located at a portion of the inner tube 30 extending out of the first outer tube 10, a first end of the balloon 20 is connected to the first outer tube 10, and a second end of the balloon 20 is connected to one end of the inner tube 30 extending out of the first outer tube 10, so that a balloon cavity of the balloon 20 is defined by the outer wall of the first outer tube 10, the outer wall of the inner tube 30 and the inner wall of the balloon 20, and materials used by the balloon 20 are saved. In addition, because the outer diameter of the inner tube 30 is different from that of the first outer tube 10, the drop height between the inner tube 30 and the first outer tube 10 provides a certain installation space for the balloon 20, so that the outer surface of the balloon 20 is prevented from protruding out of the outer surface of the first outer tube 10 in a compressed position state, and the structural compactness of the blood vessel occlusion device is improved.

For convenience of understanding, in the present embodiment, an assembly formed by the first outer tube 10 and the inner tube 30 is referred to as a catheter assembly, the balloon 20 is sleeved on the outer circumference of the catheter assembly along the length direction, and opposite ends of the balloon 20 are respectively connected to the first outer tube 10 and the inner tube 30 in a sealing manner.

The connection between the balloon 20 and the first outer tube 10 and the inner tube 30 is provided as follows:

1. the first end of the balloon 20 is sleeved on the outer peripheral surface of the first outer tube 10 and is connected with the outer peripheral surface of the first outer tube 10 in a sealing manner, and the second end of the balloon 20 is sleeved on the outer peripheral surface of the inner tube 30 and is connected with the outer peripheral surface of the inner tube 30 in a sealing manner;

2. the first end of the balloon 20 is connected to the opening edge of the first cavity opening 12 and is connected with the first cavity opening 12 in a sealing manner, and the second end of the balloon 20 is sleeved on the outer peripheral surface of the inner tube 30 and is connected with the outer peripheral surface of the inner tube 30 in a sealing manner.

Here, in order to facilitate the movement of the inner tube 30, the first outer tube 10 and the second outer tube 40 in the blood vessel, one end of the inner tube 30 away from the flow channel may be provided with a tip 33 structure, and the tip 33 may be disposed on the sleeve by sleeving, inserting or integrally molding, or the like, and of course, the balloon 20 may be connected to one end of the tip 33 close to the inner tube 30.

Further, the first outer tube 10 is threaded to the second lumen 41, such that the inner wall of the second outer tube 40 and the outer wall of the first outer tube 10 form a space for accommodating the protection component 50. Further, according to the embodiment of the sleeve structure, the cross-sectional shape of the blood vessel occlusion device can be determined by the outer peripheral surface structure of the second outer tube 40, so that the requirement for the processing accuracy of the entire device can be reduced to some extent, and the outer diameter of the device can be reduced to the maximum extent.

The protective assembly 50 of this embodiment includes a withdrawal guidewire 51 for driving the protective assembly 50 to withdraw the second lumen 41 as a whole and a support body 52 for covering the protective balloon 20 and the occlusion member 21.

The withdrawing guide wire 51 is movably connected with the second lumen 41, and the withdrawing guide wire 51 at least partially extends out of the second outer tube 40 through the second cavity opening 42; the support body 52 is connected to the withdrawal guide wire 51 and extends to the outside of the balloon 20, and a coating 522 is provided on the support body 52, the coating 522 being provided along the extending direction of the support body 52 such that the support body 52 is coated on the outer peripheral surface of the support body by the coating 522.

The withdrawn guide wire 51 serves as a support structure for the covering film 522, which can drive the support body 52 together with the covering film 522 to be unfolded along the extending direction of the support body 52 and to be received in the second lumen 41.

As shown in fig. 6 to 9, the support body 52 of the present embodiment includes at least one support wire 521, and the balloon 20 is sleeved on the catheter assembly as an example. In the case where the support wire 521 is one, the support wire 521 may be wound around the outer circumference of the balloon 20 in the axial direction in a spirally extending manner. In the case where the support wire 521 is provided in plural, the support wire 521 may be wrapped around the balloon 20 by cross-weaving or welding.

A certain gap is formed between any two adjacent supporting wires 521, the size of the gap can be adjusted according to specific surgical requirements, the covering film 522 can be fixedly connected with the supporting wire 521 on one side and covers the gap, in order to ensure the stability of the protection assembly 50, the other side of the covering film 522 can be detachably connected with the supporting wire 521 on the other side, when the support body 52 is driven to be unfolded by the withdrawing guide wire 51, the covering film 522 and the supporting wire 521 which are detachably connected can be separated from each other, and can be withdrawn into the second lumen 41 along with the supporting wire 521 fixedly connected with the support body, so that the protection assembly 50 can be successfully withdrawn.

Preferably, the support body 52 is made of nitinol, which is a shape memory alloy, and the shape memory alloy is a special alloy that can automatically restore the plastic deformation of the support body to the original shape at a certain specific temperature, and has good plasticity, so that the protection assembly 50 can be deformed, and has a certain toughness, thereby better protecting the balloon 20 and the occlusion member 21.

In this embodiment, the overall structure of the support wire 521 may be an oval shape, a fan shape, a leaf shape, or the like.

The material of the covering film 522 comprises one or more of polyurethane, polyethylene, polypropylene and other high polymer materials with elasticity, the supporting wires 521 and the covering film 522 have deformation elasticity, the protection assembly 50 can have certain deformation capacity in the human body, the internal structure of the human body can be better adapted, and the human body can not be greatly interfered with the vascular wall tissue to protect the blood vessels of the human body.

Another embodiment of the vaso-occlusive device of this embodiment is provided below, which comprises an inner tube 30, wherein separate guide channels 31 and flow channels for the flow of the filling medium are formed in the inner tube 30, so that the filling medium can flow out of or into the flow channels;

a balloon 20 configured as a hollow balloon body that is radially compressible and radially expandable under force, the lumen of the balloon 20 communicating with the flow channel, the surface of the balloon 20 providing a support for the occlusion 21;

the second outer tube 40 is provided with a hollow second tube cavity 41, and one end, close to the flow channel, of the second tube cavity 41 is communicated with the external environment to form a second cavity 42;

and the protective component 50 at least partially covers the support part, and the second lumen 41 provides a space for accommodating the protective component 50, so that the protective component 50 can be separated from the support part and enter the second lumen 41 under the action of force.

Through the above embodiment, the inner tube 30 can be directly used as a guide channel for guiding the guide wire and a flow channel for injecting the filling material, thereby further reducing the use of the tubular structure and reducing the processing difficulty of the whole device.

The intracranial aneurysm occlusion apparatus according to the present embodiment includes the above-described blood vessel occlusion device, and the occluding member 21 needs to be placed on the support section before the operation.

In order to facilitate the operation of the device, the end of the intracranial aneurysm occlusion device far away from the ostium is provided with an operating device (not shown) which provides manual operation and can integrally control the introduction of the guide wire, the withdrawal of the guide wire 51 and the filling medium, and in order to integrally control, a catheter holder 60 is provided at the end of the vascular occlusion device far away from the ostium, and three nozzles which respectively communicate with the flow channel, the second lumen 41 and the guide channel 31 are provided on the catheter holder 60, so that the guide wire, the withdrawal of the guide wire 51 and the device for injecting the filling medium can be arranged on the catheter holder 60 to facilitate the operation of the operating device.

Further, the obturator 21 is the sheet structure, and the obturator 21 includes from outer to interior range upon range of setting in proper order:

a hydrophobic layer 211 configured to have a blood-repellent fluid structure, preferably, the hydrophobic layer 211 is a silicone oil layer, which is capable of resisting blood and other immiscible contaminants well to prevent the adhesion layer 212 from being contaminated in the presence of body fluids and to maintain the integrity of the occluding member 21, so that the occluding member 21 maintains the stickiness before adhering to the arterial tissue;

one side of the adhesive layer 212, which is close to the hydrophobic layer 211, can carry a medicament and is adhered to the vascular tissue of a human body, and one side of the adhesive layer 212, which is close to the hydrophobic layer 211, is provided with particles, so that the hydrophobic layer 211 can be better attached to the adhesive layer 212 and the surface of the artery tissue can be rapidly crosslinked, and the long-term stable adhesion to the surface of the tissue is realized;

an anti-fouling layer 213 for reducing bio-fouling and post-operative inflammation, the anti-fouling layer 213 being embodied as a zwitterionic layer capable of forming a strong adhesion to the tissue surface in the presence of blood and showing an excellent resistance to bacterial adhesion, fibrinogen adsorption and in vivo fibrocyst formation, and the material for the bio-adhesion layer 212 being composed of polyacrylic acid grafted with N-hydroxysuccinimide ester (PAA-NHS ester) and chitosan.

In the process that the occluding component 21 is adhered to the surface of the artery tissue, the balloon 20 drives the occluding component 21 to apply pressure of 8-10kPa on the artery vessel wall tissue, the hydrophobic layer 211 can drain blood and other pollutants between the adhesive layer 212 and the vessel wall tissue, so that the adhesive layer 212 can be quickly sealed and attached to the vessel wall tissue, and the surface of the adhesive layer 212 can be subjected to shear-driven dehumidification, so that the protection of the adhesive layer is triggered.

To further facilitate storage and save space on the components, both the balloon 20 and the occluding element 21 are of a collapsible construction so that the occluding element 21 can be collapsed along with the balloon 20 for storage within the protective assembly 50, thereby providing a high degree of customization.

Through the arrangement, the occlusion piece 21 not only has excellent adhesion, but also has excellent displacement resistance after being adhered to the surface of artery tissue, so that certain series of complications such as thrombus caused by the displacement of the occlusion piece 21 after operation are avoided, the effects of diminishing inflammation and the like can be achieved, and the recovery speed after the operation is improved.

As shown in fig. 10, based on the intracranial aneurysm occlusion device described above, the present embodiment provides a method of using the device, the method of using including:

s10, placing a guide wire into the intracranial common artery, and penetrating the guide wire placed into the intracranial common artery to the position of the parent artery;

s20, the first outer tube 10 and the second outer tube 40 enter the parent artery along the guide wire with the inner tube 30, and the supporting part is determined to be at the lesion position;

s30, controlling the protective component 50 to withdraw the second lumen 41 and disengage the strut, so that the balloon 20 and the occlusion 21 carried on the strut are exposed in the parent artery and directly face the lesion site;

s40, injecting a filling medium into the cavity of the balloon 20 through the flow channel, wherein the filling medium adopted by the embodiment is a contrast medium, so that an operator can better determine the position of the balloon 20, and the balloon 20 is radially expanded to drive the occlusion part 21 to be close to the surface of the artery tissue;

s50, continuously injecting filling medium into the cavity of the balloon 20, and abutting and adhering the occlusion piece 21 to the surface of the artery tissue to finish the occlusion of the aneurysm cavity.

S60, expelling the filling medium from the balloon 20, returning the balloon 20 from the expanded position to the compressed position, and withdrawing the vaso-occlusive device as a whole from the patient.

In the above-mentioned operation modes, the guiding wire, the withdrawing wire 51 and the filling medium can be injected by the operation device, the operation device draws, pushes and the like to move the guiding wire and the withdrawing wire 51, and the filling medium can be injected into the balloon or discharged from the balloon 20 by a device such as a syringe.

To sum up, this scheme not only can let vascular occlusive device remove the in-process along the blood vessel and play fine guard action to occlusive member 21, can also let the better adhesion of occlusive member 21 on arterial tissue, has promoted the security of operation greatly, has reduced in the art and postoperative cause disability rate and lethality rate.

In the description herein, it is to be understood that the terms "upper," "lower," "left," "right," and the like are used in an orientation or positional relationship merely for convenience in description and simplicity of operation, and do not indicate or imply that the referenced device or element must have a particular orientation, configuration, and operation in a particular orientation, and therefore should not be construed as limiting the present invention. Furthermore, the terms "first" and "second" are used merely for descriptive purposes and are not intended to have any special meaning.

In the description herein, references to "an embodiment," "an example" or the like are intended to mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, the schematic representations of the terms used above do not necessarily refer to the same embodiment or example.

Furthermore, it should be understood that although the present description refers to embodiments, not every embodiment may contain only a single embodiment, and such description is for clarity only, and those skilled in the art should integrate the description, and the embodiments may be appropriately combined to form other embodiments as will be appreciated by those skilled in the art.

The technical principle of the present invention is described above in connection with specific embodiments. The description is made for the purpose of illustrating the principles of the invention and should not be taken in any way as limiting the scope of the invention. Based on the explanations herein, those skilled in the art will be able to conceive of other embodiments of the present invention without inventive effort, which would fall within the scope of the present invention.

Claims (14)

1. A vaso-occlusive device, comprising:

the outer tube (10) is provided with a hollow first tube cavity (11), the first tube cavity (11) provides a flow channel for flowing of a filling medium, at least one end of the first tube cavity (11) is communicated with the external environment to form a first cavity opening (12), so that the filling medium can flow out of or into the first tube cavity (11) through the first cavity opening (12);

a balloon (20) configured as a hollow balloon body radially compressible and radially expandable under force, the balloon (20) lumen communicating with the first lumen (11), the balloon (20) surface providing a support for carrying an obturator (21);

the guide wire guiding device comprises an inner tube (30), wherein a guide channel (31) is formed in the inner tube, and the guide channel (31) provides a space for guiding a guide wire to move through;

the second outer tube (40) is provided with a hollow second tube cavity (41), and one end, close to the first cavity opening (12), of the second tube cavity (41) is communicated with the external environment to form a second cavity opening (42);

a protective component (50), wherein the protective component (50) at least partially covers the support part, and the second lumen (41) provides a space for accommodating the protective component (50), so that the protective component (50) can be separated from the support part and enter the second lumen (41) under the action of force.

2. Vaso-occlusive device according to claim 1, characterized in that the inner tube (30) is threaded to the first lumen (11) so that the inner wall of the first outer tube (10) and the outer wall of the inner tube (30) form the flow path.

3. Vaso-occlusive device according to claim 2, characterized in that the inner tube (30) is spaced apart by at least two visualization rings (32), the visualization rings (32) at least partially coinciding with projections of the balloon (20) on the same axial section of the balloon (20).

4. Vaso-occlusive device according to claim 2, characterized in that said inner tube (30) projects at one end from said first orifice (12) out of said first outer tube (10);

the first end of the balloon (20) is connected with the first outer tube (10), and the second end of the balloon (20) is connected with one end of the inner tube (30) extending out of the first outer tube (10).

5. The vaso-occlusive device according to claim 4, characterized in that said first outer tube (10) and said inner tube (30) constitute a catheter assembly to which said balloon (20) is fitted lengthwise;

the two opposite ends of the balloon (20) are respectively connected with the first outer tube (10) and the inner tube (30) in a sealing way.

6. Vaso-occlusive device according to claim 1, characterized in that the first outer tube (10) is threaded to the second lumen (41) so that the inner wall of the second outer tube (40) and the outer wall of the first outer tube (10) form a space providing for housing the protective assembly (50).

7. The vaso-occlusive device according to any of claims 1-6, wherein the protective assembly (50) comprises:

a withdrawal guidewire (51) movably threaded through the second lumen (41), the withdrawal guidewire (51) extending at least partially out of the second outer tube (40) through the second lumen (42);

the supporting body (52) is connected with the withdrawing guide wire (51) and extends to the outside of the balloon (20), a coating (522) is arranged on the supporting body (52), and the coating (522) is arranged along the extending direction of the supporting body (52) so that the supporting body (52) is coated on the outer peripheral surface of the supporting part through the coating (522);

the withdrawing guide wire (51) can drive the support body (52) and the coating film (522) to be unfolded along the extending direction of the support body (52) and be received in the second lumen (41).

8. The vaso-occlusive device according to claim 7, characterized in that the support body (52) is made of nitinol.

9. The vaso-occlusive device of claim 7, wherein the material of the coating (522) comprises a combination of one or more of polyurethane, polyethylene, polypropylene.

10. A vaso-occlusive device, comprising:

an inner tube (30), wherein mutually independent guide channels (31) and flow channels for providing the flow of the filling medium are formed in the inner tube (30), so that the filling medium can flow out of or into the flow channels;

a balloon (20) configured as a hollow balloon that is radially compressible and radially expandable under force, the lumen of the balloon (20) communicating with the flow channel, the balloon (20) surface providing a support for the loading of an occlusion (21);

the second outer tube (40) is provided with a hollow second tube cavity (41), and one end, close to the flow channel, of the second tube cavity (41) is communicated with the external environment to form a second cavity opening (42);

a protective assembly (50), wherein the protective assembly (50) at least partially covers the support, and the second lumen (41) provides a space for accommodating the protective assembly (50), so that the protective assembly (50) can be separated from the support and enter the second lumen (41) under the action of force.

11. An intracranial aneurysm occlusion device, comprising:

the vaso-occlusive device of any of claims 1-10;

an occlusion member (21) is mounted on the support portion.

12. Intracranial aneurysm occlusion device according to claim 11, wherein the occlusive member (21) is a sheet-like structure, the occlusive member (21) comprising, arranged in a cascade from the outside towards the inside:

a hydrophobic layer (211) configured to have a blood-repellent fluid structure layer;

the side, close to the hydrophobic layer (211), of the adhesive layer (212) can be loaded with drugs and adhered to the vascular tissue of the human body;

an anti-fouling layer (213) for reducing biofouling and post-operative inflammation.

13. The intracranial aneurysm occlusion device of claim 11 or 12, wherein the balloon (20) and the occlusion member (21) are each of collapsible construction such that the occlusion member (21) is collapsible loaded with the balloon (20) for receipt within the protective assembly (50).

14. A method of using an intracranial aneurysm occlusion device comprising the intracranial aneurysm occlusion device of claim 11 or 12, the method of use comprising:

s10, placing a guide wire into the intracranial common artery, and penetrating the guide wire placed into the intracranial common artery to the position of the parent artery;

s20, the first outer tube (10) and the second outer tube (40) enter the parent artery along the guide wire along the inner tube (30) and determine that the supporting part is at the lesion position;

s30, controlling the protection component (50) to withdraw the second lumen (41) and disengage from the support, so that the saccule (20) and the obturator (21) loaded on the support are exposed in the parent artery and face the lesion position;

s40, injecting a filling medium into the cavity of the balloon (20) through the flow passage to radially expand the balloon (20) so as to drive the occlusion piece (21) to be close to the surface of the artery tissue;

s50, continuously injecting filling medium into the sac cavity of the balloon (20) and abutting and adhering the occlusion piece (21) to the surface of the artery tissue to finish the occlusion of the aneurysm cavity.

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