CN108245216A - A kind of aneurysm treatment system - Google Patents

Abstract

An aneurysm treatment system comprising: a delivery device and a hydrogel system, wherein the delivery device includes an internal infusion catheter for injecting the hydrogel system at a lesion site, an external delivery catheter for delivering the internal infusion catheter a catheter, and a wire for guiding the inner delivery catheter and the outer delivery catheter to the lesion site; the hydrogel system includes at least two hydrogels that will form a hydrogel when mixed Builder. Implementing the aneurysm treatment system of the present invention, since the effect of the endovascular stent is temporary, it can be removed after completion, so there will be no permanent foreign matter lodged in the patient's aneurysm sac, thus reducing side effects and complications, moreover, the described aneurysm treatment system can also be easily adapted to wide-necked and odd-shaped aneurysms.

Description

An aneurysm treatment system

technical field

The invention relates to the field of tumor treatment, and more specifically relates to an aneurysm treatment system.

Background technique

An intracranial aneurysm is a vascular malformation that implies dilatation of the vessel wall and weakening of the wall structure. Intracranial aneurysms frequently arise in the ring of cerebral arteries, an important part of the brain's circulatory system. Intracranial aneurysms can have several fatal complications. If left untreated, the aneurysm may continue to grow large, causing headaches, nausea, and other symptoms. Aneurysms are also at risk of rupture. A ruptured aneurysm can cause serious symptoms, such as a subarachnoid hemorrhage or a hemorrhagic stroke. These complications have a high mortality rate and require immediate surgical treatment. The risk of aneurysm rupture is 1.3% per year, with an incidence of 10.5 per 100,000.

A variety of treatments have been used for intracranial aneurysms, depending on the patient's condition and the development of the aneurysm. These treatments include drug delivery, surgical clipping, and endovascular techniques. Endovascular techniques include endovascular coiling, flow diversion, drug-eluting stent, and flow disruption.

The International Study of Unruptured Intracranial Aneurysms (ISUIA) pointed out that for small aneurysms (less than 10 mm), the risk of rupture is relatively low, while the surgical mortality rate is quite high. Patients are therefore usually treated with medication. Antihypertensive drugs, such as calcium channel blockers, can be given to control blood pressure, which reduces the risk of aneurysm rupture and hinders aneurysm growth. However, the management of unruptured aneurysms is highly controversial, mainly because there are no standard anatomical features and morphological structures for unruptured aneurysms, and the risk estimation of unruptured aneurysms based on medical images is empirical. Medication is very effective in controlling blood pressure, but its effect on intracranial aneurysms remains unclear.

Surgical clipping is one of the earliest methods for the treatment of ruptured intracranial aneurysms, and it is still widely used in less developed countries and regions. For such treatment, a craniotomy is necessary, followed by placement of surgical clips across the neck of the ruptured aneurysm. The clips clamp the aneurysm away from the parent blood vessel, preventing bleeding. Craniotomy carries higher risks and is usually reserved for acute and life-threatening symptoms following a ruptured aneurysm when no other option is available. The main disadvantage of surgical clipping is the high mortality rate of craniotomy. Surgical clips need to stay in the patient's body, so as a foreign body may cause problems in long-term inflammation and immune response.

To avoid the high risks of craniotomy, doctors and researchers have developed endovascular techniques to treat intracranial aneurysms that require only neurological intervention. The basis of neurosurgery is vascular imaging and angiography, which requires the use of intravascular catheters and X-ray machines. The surgeon will make a minimally invasive incision in the patient's groin. Insert the lead into the patient's limb artery. The lead has radiopaque markings and can be used to pass through the blood circulatory system. The wire passes through the groin, aorta, subclavian artery, and vertebral artery, and finally to the lesion site. Through this guide wire, medical implants such as stents can be implanted via the catheter. Balloon catheters are sometimes used to expand stents or to provide angioplasty for blocked blood vessels.

Modern devices for endovascular treatment of intracranial aneurysms include endovascular stents, endovascular coils, flow directors, and more recently flow disruptors. Stents are widely used in the treatment of cardiovascular disease and abdominal aortic disease. A stent can be implanted at the above-described locations using the methods described above. Stents essentially widen blocked blood vessels and support damaged and collapsed vessel wall structures. Compared with surgical clipping, coil embolization greatly reduces the operative mortality, and the complications are not serious. In the early stages of stent development, they were made of bare metal, such as stainless steel. With the development of alloy technology, new materials such as titanium alloy and cobalt-chromium alloy are used to manufacture stents. These materials have excellent properties, including good biocompatibility, shape memory, and superelasticity. With bare metal stents, the main problem is leaving foreign objects in the patient's blood vessels. Deployment of the stent will impinge on the flow field of the region, thereby disrupting blood flow which may lead to the formation of plaque and blood clots leading to blockage. Another problem with bare metal stents is stress concentration and thus damage to the vessel wall. This is considered an important cause of restenosis.

To reduce side effects of bare metal stents, new technologies such as bioresorbable stents and drug-eluting stents have been developed. Biodegradable scaffolds are composed of bioabsorbable materials such as polylactic acid, polyglycolic acid polymers and their copolymers. A biodegradable stent will support a weakened blood vessel for a certain period of time and will degrade over time. This reduces the problem of permanent foreign bodies in the blood vessel. However, a disadvantage of biodegradable stents is their lower mechanical properties compared to bare metal stents. Due to the nature of the polymeric material, the usability and strength of these stents is low. Bioabsorbable metal stents using biodegradable metals such as magnesium are an emerging technology. No viable model of bioabsorption has been found so far.

Drug-eluting stents have been developed to provide a better bond between the stent and the vessel lining and reduce the risk of blood clotting. There are several ways to provide drugs and stents. One is to coat the surface of the stent with a drug-carrying polymeric pattern, and the other is to construct a microstructure along the stent struts, and embed drug particles in the pores of the microstructure. Vascular endothelial growth factor and anticoagulant drugs are commonly used drugs. Drug-eluting stents are a promising technology, but the treatment is quite expensive. The complexity of scaffold fabrication and post-processing makes scaffolds expensive. At the same time, the drug carried by the stent will wash away over time, which will reduce the efficacy of the stent.

Endovascular coil embolization is widely used in the treatment of intracranial aneurysms and has proven to be an effective treatment. Some analyzes have shown that endovascular coil embolization has better clinical outcomes than surgical clipping. After the leads are deployed as described above for neurointerventional procedures, a catheter carrying a medical coil will be inserted. The coil is usually made of a noble metal, such as platinum, which is both biocompatible and visible under X-rays. After the tip of the coil enters the aneurysm wall, the neurosurgeon will begin releasing the coil from the delivery catheter. Under the guidance of the neurosurgeon, the coil will be crimped in the aneurysm and fill the cavity. This release is usually reversible and the coil can be partially retracted for better deployment, a process that may require repeated back and forth several times, which is time consuming. The placement of intravascular coils is very delicate because of the need to control the winding direction and packing density, thus requiring a highly trained and experienced neurosurgeon. Furthermore, when the aneurysm dome is provided with a coil, blood flow within the aneurysm is reduced, which will lead to the formation of a blood clot within the aneurysm, which in turn will embolize the aneurysm sac from the parent vessel. This is why this type of treatment is also called embolization. Some studies have also found that after aneurysm occlusion, a neointimal layer can form in the neck of the aneurysm. A limitation of endovascular coil embolization is that it can only be deployed in selected cases. With wide-necked aneurysms, the coils are difficult to place within the aneurysm and risk being washed away. Another problem with this technique is that the platinum coil is also a foreign body and will permanently reside within the aneurysm. In addition, it may also trigger an immune response and put pressure on peripheral nerves and brain tissue. To solve these problems, new technologies such as bioabsorbable coils and eluting coils have also been considered. Stent-assisted coiling is a combination of stent and endovascular interventional technology. Although it increases the application range of the coil, it also increases the cost and difficulty of the operation.

For the treatment of large, unusually shaped aneurysms, flow diversion techniques have been introduced. Blood flow directors have a stent structure, but they generally have higher elasticity and lower porosity than traditional stents. Unlike traditional stent manufacturing techniques, such as laser cutting and etching, blood flow directors usually use weaving technology. Multiple metal threads, such as nitinol threads, are braided together and heated to form the blood flow director. Since there is no firm connection between the metal threads, this blood flow guide will be highly elastic and therefore better controlled in locations of high curvature. The porosity of the blood flow director can be easily increased by adjusting the ratio of angle of attack and weaving speed. The porous structure will reduce blood flow from the parent vessel to the aneurysm sac, which will trigger the coagulation cascade. A blood clot will gradually form within the aneurysm and prevent possible bleeding, which is why flow diversion techniques are also classified as embolization techniques. Flow steering has proven to be a good alternative to endovascular coil embolization, but it has some problems. Although the flow director is highly elastic, its tubular shape will create a gap between the flow director and the vessel, so the occlusion will fail. Also, the length of the flow director usually exceeds the size of the lesion and the flow director may cover side branches. Due to the high porosity of the flow director, blood flow into the lateral branches will be reduced, which may lead to ischemic injury to the downstream nervous system. Recent clinical results show that, in the long run, flow directors lead to thrombolytic activity within 14 days, followed by delayed rupture. In contrast to stent and endovascular coil embolization, flow directors are not suitable for patients with intracranial aneurysms.

An emerging therapy for the treatment of intracranial aneurysms is the devascularization technique. Similar to stents and flow directors, interrupters are usually made of biocompatible materials in the shape of a lantern. Circuit interrupters can also be implanted through neurointerventional methods. It can be stored in a medical catheter and delivered to the lesion by wire. Once the tip of the catheter enters the aneurysm wall, the cutout is released and the cutout expands to fit the aneurysm wall. Because of the low porosity at the bottom of the interrupter, blood flow to the aneurysm is interrupted and embolism occurs. Compared with directing blood flow, the devascularization method only leaves the foreign body at the tip of the aneurysm and the devascularization device only makes contact with the aneurysm wall. After a blood clot forms inside the aneurysm, a neointima layer will form across the neck, which will allow better embolization of the aneurysm from the parent vessel, thus eliminating damage to the parent vessel wall. The devascularization technique can also reduce the difficulty of manipulation for the neurosurgeon, which is easier to deploy compared with endovascular coil embolization. The devascularization technique has proven to be a very promising technique for the treatment of intracranial aneurysms, especially those with wide necks and odd shapes. However, it still presents technical problems due to foreign solids residing on top of the aneurysm and possibly causing an inflammatory reaction. At the same time, the manufacturing process of the complex geometric shape of the cutout is complicated, which increases the cost of the product.

Contents of the invention

The technical problem to be solved by the present invention is to provide an aneurysm treatment system that is easy to manufacture, has good curative effect, has few side effects and complications, and is suitable for various aneurysm diseases.

The technical solution adopted by the present invention to solve the technical problem is to construct a treatment system for aneurysm, including: a delivery device and a hydrogel system, wherein the delivery device includes a hydrogel system for injecting the hydrogel system at the lesion site An inner injection catheter for delivering the inner injection catheter, an outer delivery catheter for delivering the inner injection catheter, and a wire for guiding the inner delivery catheter and the outer delivery catheter to the lesion site; the hydrogel system includes mixing At least two hydrogel formers that will form a hydrogel when present.

In the aneurysm treatment system of the present invention, the internal injection catheter includes a first internal injection catheter for injecting the first hydrogel forming agent at the lesion site, and a first internal injection catheter for injecting the second hydrogel forming agent at the lesion site. A second inner injection catheter for gel forming agent, the outer delivery catheter is sheathed on the outside of the first inner injection catheter, the second inner injection catheter and the guide wire.

In the aneurysm treatment system of the present invention, the delivery device further includes an intravascular stent disposed inside the blood vessel at the lesion site.

In the aneurysm treatment system of the present invention, the internal injection catheter, the external delivery catheter and the guide wire pass through the stent wall of the intravascular stent and enter the aneurysm cavity at the lesion site.

In the aneurysm treatment system of the present invention, the intravascular stent is arranged on one side of the inner injection catheter, the outer delivery catheter and the guide wire, and the inner injection catheter, the outer delivery catheter and the The guide wire enters the aneurysm cavity at the lesion site over one side of the intravascular stent.

In the aneurysm treatment system of the present invention, the intravascular stent has a mesh structure and is manufactured by weaving or laser cutting.

In the aneurysm treatment system of the present invention, the intravascular stent is a biodegradable or bioabsorbable stent, or a retrievable intravascular stent.

In the aneurysm treatment system of the present invention, the internal injection catheter further includes an additional internal injection catheter for performing functional treatment at the lesion site.

In the aneurysm treatment system of the present invention, the hydrogel system includes a liquid polymer solution and a chelating agent, a pH-sensitive hydrogel solution and an acidic or alkaline physiological buffer solution, or a temperature-sensitive Hydrogel solutions and hot or cold physiological buffer solutions, or combinations thereof.

In the aneurysm treatment system of the present invention, the liquid polymer solution includes sodium alginate solution poly or acrylic acid solution, and the chelating agent includes calcium chloride or calcium gluconate.

Implementing the aneurysm treatment system of the present invention, because the effect of the endovascular stent is temporary, it can be removed after completion, so there will be no permanent foreign matter residing in the patient's aneurysm sac, thus reducing side effects and complications, which include high mortality from craniotomy, inflammatory and immune responses, and damage to vessel walls and reduced blood flow to side branches. In addition, the described aneurysm treatment system can also easily accommodate wide-necked and odd-shaped aneurysms, which are difficult for other treatment methods. After the stent is removed and the hydrogel degrades, the aneurysm is self-healing. This places less stress on the tissue and utilizes the body's potential. Therefore, the aneurysm treatment system of the present invention can be widely applied to various cases and has high curative effect.

Description of drawings

The present invention will be further described below in conjunction with accompanying drawing and embodiment, in the accompanying drawing:

1A is a schematic diagram of a delivery device of an aneurysm treatment system according to a first embodiment of the present invention;

Fig. 1B is a schematic structural view of a preferred embodiment of the delivery device shown in Fig. 1A;

1C is a schematic diagram of the hydrogel embolization of aneurysms of the aneurysm treatment system according to the first embodiment of the present invention;

Figure 1D is a schematic diagram of the formation of a blood clot in an aneurysm;

2A is a schematic diagram of a delivery device of an aneurysm treatment system according to a second embodiment of the present invention;

Figure 2B is a schematic diagram of the formation of aneurysm embolism;

Figure 2C is a schematic diagram of the formation of a blood clot in an aneurysm;

Figures 2D-2E show different intravascular stents;

3A is a schematic diagram of a delivery device of an aneurysm treatment system according to a third embodiment of the present invention;

3B is a schematic diagram of a delivery device of an aneurysm treatment system according to a fourth embodiment of the present invention;

3C is a schematic diagram of a delivery device of an aneurysm treatment system according to a fifth embodiment of the present invention;

4A-4D illustrate various aneurysms for use with the aneurysm treatment system of the present invention.

Detailed ways

In order to make the object, technical solution and advantages of the present invention clearer, the present invention will be further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described here are only used to explain the present invention, not to limit the present invention.

Based on the above prior art analysis, the following conclusions can be drawn. The principles of intracranial aneurysm treatment induce clot formation within the aneurysm lumen, thereby allowing its embolization from the parent vessel. The same principles apply to endovascular therapeutic approaches, including endovascular coil embolization, flow diversion, and devascularization techniques. The rationale is to employ an embolization protocol to embolize the aneurysm with a blood clot. Tissue remodeling follows clot formation, during which the clot becomes new vascular tissue that better embolizes the aneurysm. Recent animal studies suggest that these tissue remodeling events may involve three phases. In the early stages, strengthening and degradation of fibrin occurs. In the metaphase, macrophages infiltrate the clot and proliferate, accompanied by collagen synthesis. In later stages, newly synthesized collagen reorganizes and myofibroblasts form. These activities will alter the aneurysm morphology and the aneurysm sac will not be visible on angiography. This theory also explains the effectiveness of embolization therapy.

Based on the above understanding of embolization treatment methods, a new treatment system is proposed. The system utilizes the in situ hydrogel formation process. Delivery of a liquid gel-forming agent to the aneurysm lumen for sequestration to form a hydrogel occludes the aneurysm sac from the parent vessel. The stagnant environment in the aneurysm sac combined with clot-forming compounds released from the newly formed hydrogel will form a clot within the aneurysm. The hydrogel will continue to degrade allowing the aneurysm to be embolized by the clot alone. The clot then remodels the tissue and the aneurysm heals on its own. Additional biological factors can be added to the hydrogel so that they can be released during hydrogel degradation and accelerate the aneurysm healing process.

This therapeutic system consists of two main components, the delivery device and the hydrogel system. The delivery device includes an inner infusion catheter for infusing the hydrogel system at a lesion site, an outer delivery catheter for delivering the inner infusion catheter, and for guiding the inner and outer delivery catheters Lead wires to the lesion site. The outer delivery catheter and inner infusion catheter can be supported with medical grade polymer and the wires are made of biocompatible metal with radiographic markers. The hydrogel system includes at least two hydrogel formers that will form a hydrogel when mixed. In a preferred embodiment of the present invention, the hydrogel system includes a gel and a chelating agent, as well as clot-forming compounds and biological factors. In a preferred embodiment of the present invention, an intravascular stent for assisting the gel delivery process may also be included. The intravascular stent is generally made of biocompatible metal or alloy.

The advantage of the aneurysm treatment system of the present invention is that since the effect of the endovascular stent is temporary, it can be removed after completion, so there is no permanent foreign body lodged in the patient's aneurysm sac, As a result, side effects and complications, including high mortality from craniotomy, inflammatory and immune responses, and damage to vessel walls and reduced blood flow to side branches, can be reduced. In addition, the described aneurysm treatment system can also easily accommodate wide-necked and odd-shaped aneurysms, which are difficult for other treatment methods. After the stent is removed and the hydrogel degrades, the aneurysm is self-healing. This places less stress on the tissue and utilizes the body's potential. Therefore, the aneurysm treatment system of the present invention can be widely applied to various cases and has high curative effect.

Figure 1A shows a cross-sectional view of a blood vessel 100 with an aneurysm sac 101, in which is shown a delivery device 102 of an aneurysm treatment system according to a first embodiment of the present invention. Blood flow is from left to right as shown. The basic configuration of delivery device 102 is shown in FIG. 1B . Two internal injection catheters 105 are used to deliver the two complementary agents that form the hydrogel. The two inner injection catheters 105 are nested within the outer delivery catheter 103 . A guide wire 104 is used for guidance of the inner injection catheter and outer delivery catheter. The outer delivery catheter 103 and the inner injection catheter 105 are made of medical-grade polymer materials, which include the most commonly used polyamide, polyurethane, fluororesin, polyolefin, polyvinyl chloride (PVC), Polyimide, and polyether ether ketone (PEEK), which can be expanded into a spherical shape by physiological saline or buffer solution. In one embodiment of the invention, the hydrogel-forming agent that forms the hydrogel comprises a liquid polymer solution and a chelating agent. The liquid polymer solution may be sodium alginate solution, polyacrylic acid solution and the like. The chelating agent can be calcium chloride, calcium gluconate and the like. In another embodiment of the present invention, the hydrogel-forming agent that forms the hydrogel includes a pH-sensitive hydrogel solution and an acidic or alkaline physiological buffer solution. In another embodiment of the present invention, the hydrogel-forming agent that forms the hydrogel comprises a temperature-sensitive hydrogel solution and a hot or cold physiological buffer solution. Hydrogels can be formed by mixing two or more groups of hydrogel formers.

Stainless steel and nitinol are commonly used lead materials on the market, often in combination with radiopaque metal markers. During treatment, imaging techniques such as digital subtraction angiography (DSA) can be used to guide wires to the site of the lesion. When the guidewire reaches the top of the aneurysm, the outer delivery catheter 103 carrying the two inner injection catheters 105 will be inserted at the focal site. As the two inner injection catheters 105 enter the apex of the aneurysm, two hydrogel formers will be gradually released into the apex of the aneurysm where they gel in situ.

The newly formed hydrogel aggregates across the neck at the top of the aneurysm and performs two functions. First, it acts as a physical occlusion between the aneurysm sac and the parent vessel, enabling it to prevent ongoing leaks. Second, the hydrogel gradually degrades and releases biological factors into the aneurysm sac, thereby assisting intracranial aneurysm clot formation. Factors for clot formation include, but are not limited to, calcium ions, which themselves are chelating agents, such as calcium chloride, calcium gluconate, and the like. Additional biological factors including but not limited to fibroblasts may also be added to accelerate the following healing process. Figure 1C shows hydrogel 106 embolizing an aneurysm. The subsequent formation of a blood clot 107 within an intracranial aneurysm is shown in FIG. 1D .

Fig. 2A shows a cross-sectional view of a blood vessel with an aneurysm 200, wherein an aneurysm treatment system according to a second embodiment of the present invention is shown. The aneurysm treatment system includes, for example, a delivery system 202 , a hydrogel system and an intravascular stent 201 .

As previously mentioned, when employing a delivery system 102 that includes only an inner injection catheter, an outer delivery catheter, and a guidewire, the following drawbacks may exist. The delivery system is unable to restrain the gel formed in the aneurysm 200 and thus the resulting hydrogel cannot completely seal the aneurysm 200 . Part of the clot-forming factors released later will therefore enter the parental blood vessel and form a clot downstream. If a good blood clot does not form within the aneurysm 200, subsequent treatment procedures will likely not be performed very effectively. Therefore, in order to obtain better curative effect, in this preferred embodiment of the present invention, intravascular stent technology is introduced to solve these problems.

The intravascular stent 201 may be formed of biocompatible materials including stainless steel, titanium alloy or cobalt chromium. The manufacturing method of the intravascular stent 201 includes but not limited to weaving and laser cutting. During the operation, the intravascular stent 201 is firstly placed below the neck of the aneurysm according to the traditional intravascular stent placement technique. After successful deployment of endovascular stent 201, a guidewire is inserted into the patient's vascular system from the same opening in the patient's groin. The guidewire is visualized and guided through the stent wall into the aneurysm lumen. When the guidewire is ready, the hydrogel's inner injection catheter and outer delivery catheter can be deployed through the stent wall and into the aneurysm cavity. Through the internal injection catheter, a hydrogel-forming agent can be injected into the aneurysm cavity and form a hydrogel in the aneurysm cavity. The intravascular stent 201 has a mesh structure. Due to this network structure, the hydrogel will not leak from the aneurysm lumen into the parent vessel. Aneurysm embolization 203 is shown in Figure 2B and clot 204 formation is shown in Figure 2C. The aneurysm treatment can then be triggered on its own. 2D-2E show different endovascular stents 205,206. The intravascular stents 205, 206 may have different mesh densities. The choice of scaffold mesh density depends on the newly formed hydrogel particle size. Scaffolds with low mesh density have better elasticity and are easier to deploy, and scaffolds with low mesh density can reduce the risk of hydrogel leakage into the parent vessel. Those skilled in the art can select an appropriate mesh density based on the degree of aneurysm development, the particle size of the hydrogel, and other treatment factors.

In other embodiments of the present invention, the delivery device of the aneurysm treatment system of the present invention may also adopt other different structures. As shown in FIG. 3A , delivery device 301 may include multiple inner injection catheters, eg, in addition to two inner injection catheters, an additional inner injection catheter 302 for various medical purposes. For example, when a hydrogel-forming agent is injected into the aneurysm sac through two inner injection catheters, and aneurysm embolization is found to occur during the procedure, the additional inner injection catheter 302 can be used as a suction. Additionally, an additional inner injection catheter 302 may also be used to provide drug access to the embolized aneurysm sac after the gelation process. Thus, the additional inner injection catheter 302 can be used for any known or later developed functional treatment of aneurysms.

In the embodiment shown in FIG. 3B , the delivery device may include a retrievable endovascular stent 303 . Since the function of the intravascular stent is to temporarily block the parent vessel to prevent any possible hydrogel leakage, it is reasonable not to permanently reside the stent in the vessel. In this design, the retrievable endovascular stent 303 is first delivered to the lesion site and partially deployed across the aneurysm. The inner injection catheter and outer delivery catheter of the hydrogel are then deployed. Through the internal injection catheter, a hydrogel-forming agent can be injected into the aneurysm cavity and form a hydrogel in the aneurysm cavity. After the hydrogel completely occupies the neck of the aneurysm, the retractable endovascular stent 303 can be retracted. In this embodiment, the retrievable endovascular stent 303 of the delivery device is designed to be retractable from the external delivery catheter. The advantage of this design is that no foreign matter is left in the human body after the treatment process is over. In another alternative embodiment of the invention, biodegradable or bioabsorbable scaffolds may be used. For example, a scaffold woven with one or more biodegradable or bioabsorbable fibers.

In another embodiment of the present invention, the intravascular stent may not be placed first. As shown in FIG. 3C , the inner injection catheter and the outer delivery catheter were first guided and placed in the aneurysm lumen, followed by placement of the endovascular stent on one side of the outer delivery catheter, followed by the gel formation process. With this design, in the retrieval stage, since the delivery path of the hydrogel is outside the intravascular stent, the hydrogel will not be damaged when the intravascular stent is retracted.

In yet another preferred embodiment of the invention, the delivery device may comprise more or less internal injection catheters. In a simplified embodiment of the invention, the delivery device may comprise an inner injection catheter and an outer delivery catheter. In this embodiment, the outer delivery catheter may be loaded with one hydrogel-forming agent while the inner injection catheter is loaded with the other hydrogel-forming agent. After the two are mixed in the aneurysm cavity, a hydrogel can be formed. In other preferred embodiments of the invention, multiple internal injection catheters may be used. For example, in a preferred embodiment of the present invention, four internal injection conduits may be included, wherein the first internal injection conduit contains sodium alginate solution, the second internal injection conduit contains calcium chloride, and the third internal injection conduit contains the pH Sensitive hydrogel solution, the second inner injection catheter holds an alkaline physiological buffer solution. When the sodium alginate solution is mixed with calcium chloride, and/or the pH-sensitive hydrogel solution is mixed with the alkaline physiological buffer solution, a hydrogel will be formed respectively.

The aneurysm treatment system of the present invention is particularly effective in treating specific types of aneurysms. 4A-4D illustrate various aneurysms for use with the aneurysm treatment system of the present invention. Gelling polymers can be applied to seal giant aneurysms (Fig. 4A) and wide-necked aneurysms (Fig. 4B), and due to the natural properties of the polymer, it can spontaneously adapt to the aneurysm wall during gelation . In addition, according to neurosurgeons, there are two types of aneurysms that are difficult to treat with currently available treatment options or devices: bifurcation aneurysms and fusiform aneurysms. However, with the aneurysm treatment system of the present invention, for the aneurysm at the bifurcation site, the hydrogel polymer can easily form a sealing layer at the neck of the aneurysm ( FIG. 4 c ). For fusiform aneurysms, hydrogel polymers can be combined with auxiliary stents to fill the aneurysm cavity (Fig. 4d). Therefore, adopting the aneurysm treatment system of the present invention can treat various special types of aneurysms particularly effectively.

The above descriptions are only preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements and improvements made within the spirit and principles of the present invention should be included in the protection of the present invention. within range.

Claims (10)

1. a kind of aneurysm treatment system, which is characterized in that including：Conveying device and aquogel system, wherein the conveying dress It puts and injects conduit including being used to inject the inside of the aquogel system in lesion site, convey the outer of the internal injection conduit Portion's delivery conduit and for the delivered inside conduit and the external delivery conduit to be directed to leading for the lesion site Line；The aquogel system will generate at least two hydrogel generating agents of hydrogel when being included in mixing.

2. aneurysm treatment system according to claim 1, which is characterized in that the internal injection conduit include for Lesion site injects the first inside injection conduit of the first hydrogel generating agent, is given birth to for injecting the second hydrogel in lesion site Into the second inside injection conduit of agent, the external delivery conduit is set in injection conduit inside described first, in described second Portion is injected outside conduit and the conducting wire.

3. aneurysm treatment system according to claim 1 or 2, which is characterized in that the conveying device further comprises It is arranged on the endovascular stent of the internal blood vessel of lesion site.

4. aneurysm treatment system according to claim 3, which is characterized in that the internal injection conduit, the outside Delivery conduit and the conducting wire pass through the cradle wall of the endovascular stent to enter the aneurysm cavity of lesion site.

5. aneurysm treatment system according to claim 3, which is characterized in that the endovascular stent is arranged in described The side of portion's injection conduit, the external delivery conduit and the conducting wire, the internal injection conduit, the external delivery conduit Enter the aneurysm cavity of lesion site above the side of the endovascular stent with the conducting wire.

6. aneurysm treatment system according to claim 3, which is characterized in that the endovascular stent has reticular structure And by weaving or being cut by laser manufacture.

7. aneurysm treatment system according to claim 3, which is characterized in that the endovascular stent is biodegradable Either biological absorbable support or for recyclable endovascular stent.

8. aneurysm treatment system according to claim 2, which is characterized in that the internal injection conduit further comprises For carrying out the additional internal injection catheter of functional therapeutic in lesion site.

9. aneurysm treatment system according to claim 1, which is characterized in that the aquogel system includes liquid polymerization Object solution and chelating agent, the physiological buffered solution or temperature sensitive of hydrogel solution and acidity or alkalinity to pH sensitivities Hydrogel solution and heat or cold physiological buffered solution, or combination.

10. aneurysm treatment system according to claim 9, which is characterized in that the liquid polymer solution includes sea Solution of sodium alginate is gathered or acrylic acid solution, and the chelating agent includes calcium chloride or calcium gluconate.