Aorta intracavitary stent with external expansion balloon

Abstract

The utility model discloses an aorta intracavitary stent with an external expansion balloon, and belongs to the technical field of medical instruments. Comprising a covered stent, at least one degradable balloon is arranged on the outer side of the covered stent in the length direction, and the degradable balloon is filled with hydrogel. According to the aorta intracavitary stent with the external expansion balloon, the degradable balloon is arranged outside the covered stent, the hydrogel is filled in the degradable balloon, and the anchoring capacity of the stent to blood vessels can be improved through the external expansion balloon at the early stage; in the later stage, the balloon releases the internal hydrogel through self-degradation or under the action of external force, expands after being in contact with blood, and allows fibroblasts and the like to enter and grow, so that thrombosis of the aortic aneurysm can be promoted, and a tumor cavity can be stabilized.

Description

Technical Field

[0001] The utility model relates to an aortic intraluminal stent with an external expansion balloon, belonging to the technical field of medical equipment. Background Art

[0002] Aortic aneurysm refers to a pathological dilation of the aorta that exceeds 50% of its normal diameter. Aortic aneurysms are categorized as true aortic aneurysms and false aortic aneurysms. True aneurysms are widenings of the blood vessel that involve the three layers of the vessel wall. False aneurysms are caused by a partial rupture of the artery, blocked by a blood clot or adjacent tissue.

[0003] Aortic aneurysms can be caused by atherosclerosis, cystic necrosis of the vascular media, syphilis, bacterial infection, rheumatic aortitis, and trauma. The most common cause is atherosclerosis.

[0004] Existing treatment options include medical treatment and surgical treatment.

[0005] Among them, 1. Internal medicine treatment, control of hypertension, treatment of accompanying diseases such as diabetes, hyperlipidemia, coronary heart disease and heart failure, etc.

[0006] 2. Surgical treatment: For ruptured aortic aneurysms, emergency surgery should be performed as soon as possible. For unruptured aortic aneurysms, if symptoms such as abdominal pain and back pain occur, surgical intervention is indicated. For unruptured and asymptomatic aortic aneurysms, if the diameter increases to a certain extent or the growth rate is rapid, the risk of rupture increases, and surgical intervention is also indicated. For example, in abdominal aortic aneurysms, if the diameter is generally greater than 4.5 cm, or the growth is greater than 5 mm in half a year, surgical treatment is indicated. Currently, there are two main types of surgical treatment methods:

[0007] (1) Open surgery, i.e., laparotomy or thoracotomy, to perform aneurysm resection and artificial blood vessel placement, is the traditional treatment method. The surgery is invasive and risky, and the patient's physical condition is also relatively high.

[0008] (2) Endovascular repair: Through arterial puncture or a small incision, a covered stent is implanted in the aorta to isolate the aneurysm cavity and reconstruct the blood flow pathway in situ. Because it does not require thoracotomy or laparotomy, it has the advantages of less trauma and faster recovery.

[0009] In the prior art, for endovascular repair, a stent graft needs to be implanted in the aorta, and currently, barbs, externally expandable stents, and externally expandable filling balloons are used to anchor the stent graft.

[0010] However, the above-mentioned implantation methods all have defects: (1) The barbs can easily cause further damage to the inner membrane of the aortic cavity, resulting in adverse consequences such as vascular tearing, dissection tearing, and aneurysm rupture; (2) The external expandable stent is a rigid structure that does not fit tightly enough with the vascular structure and can easily cause vascular damage; (3) The filled external expandable balloon requires an external catheter and relies entirely on external filling. The space-occupying effect after filling prevents the aneurysm cavity from thrombosis, and the friction between the external expandable balloon and the vascular wall causes certain damage to the vascular wall. In the later stage, the aneurysm cavity is unstable and there is still a risk of rupture. Utility Model Content

[0011] In order to solve the above technical problems, the purpose of the utility model is to provide an intraluminal aortic stent with an external expansion balloon. A degradable balloon is arranged on the outside of the coated stent, and the degradable balloon is filled with hydrogel. The balloon releases the internal hydrogel through self-degradation or under the action of external force, and expands after contacting with blood, which can promote late aortic aneurysm thrombosis and stabilize the aneurysm cavity.

[0012] The technical problem to be solved by the present invention is achieved by adopting the following technical solutions:

[0013] This utility model provides an intraluminal aortic stent with an externally inflatable balloon, including a covered stent. A covered stent is a metal stent coated with a special membrane material (such as polytetrafluoroethylene, Dacron, polyester, or polyurethane). While retaining the functions of a metal stent, it also possesses the characteristics of a membrane material. Implanting the covered stent within the aorta can isolate the aneurysm cavity and reconstruct blood flow in situ.

[0014] The utility model makes innovations based on the original coated stent. At least one degradable balloon is provided along the outer side of the coated stent in the length direction. The degradable balloon is connected to the coated stent by bonding. The degradable balloon and the membrane of the coated stent are bonded and connected. The degradable balloon is made of polylactic acid-glycolic acid copolymer. Polylactic acid-glycolic acid copolymer (poly(lactic-co-glycolic acid, PLGA) is formed by random polymerization of two monomers - lactic acid and glycolic acid. It is a degradable functional polymer organic compound with good biocompatibility, non-toxicity, and good capsule-forming and film-forming properties.

[0015] The interior of the degradable balloon is filled with hydrogel, which will degrade about 3 weeks after entering the human body, releasing the hydrogel inside. The hydrogel is released into the tumor cavity, quickly combines with the blood therein to form a thrombus, and thrombi the tumor cavity and stabilize it.

[0016] As a preferred embodiment, a degradable balloon filled with hydrogel is placed on each side of the stent graft, with the two balloons located at either end of the cross-sectional diameter of the stent graft. Placing a degradable balloon on one side of the stent graft targets aneurysm bulges on one side of the artery, while placing degradable balloons on both sides of the stent graft targets aneurysm bulges on both sides of the artery.

[0017] As a preferred example, the stent graft comprises a bare crown portion and a support portion from top to bottom, the degradable balloon is adhesively connected to the support portion of the stent graft, and the length of the degradable balloon is roughly the same as that of the support portion of the stent graft.

[0018] As a preferred example, the degradable balloon is connected to a pulling activation device for destroying the degradable balloon and releasing the internal hydrogel. The pulling activation device adopts a pull wire. A suture pull wire is reserved on the degradable balloon. The distal end of the suture pull wire outside the body is pulled to destroy the degradable balloon and release the internal hydrogel.

[0019] As a preferred example, the degradable balloon is connected to a filling tube for filling the interior of the degradable balloon with hydrogel.

[0020] Each of the degradable balloons is connected to a filling tube for filling the interior of the degradable balloon with hydrogel.

[0021] A connecting portion is provided between the biodegradable balloons on either side of the stent graft. Both ends of the connecting portion are connected to the two biodegradable balloons. A filling tube is connected to one of the biodegradable balloons. During surgery, the biodegradable balloon can be refilled with hydrogel through the filling tube to expand it. The biodegradable balloon fills the aneurysm cavity, stabilizing it and preventing type I and type II endoleaks in the stent graft after surgery.

[0022] The beneficial effects of the utility model are:

[0023] (1) The present invention provides an intraluminal aortic stent with an external expansion balloon. A degradable balloon is provided on the outside of the coated stent. The degradable balloon is filled with hydrogel. The early external expansion balloon can increase the anchoring ability of the stent to the blood vessel. In the later stage, the balloon releases the internal hydrogel by self-degradation or under the action of external force. After contacting with blood, the hydrogel expands, allowing fibroblasts and the like to enter and grow, which can promote aortic aneurysm thrombosis and stabilize the aneurysm cavity.

[0024] (2) Through the present invention, a pulling start device is connected to the degradable balloon, which creates a rupture in the degradable balloon, allowing blood from outside to enter and fill the balloon. The blood combines with the hydrogel and expands, generating negative pressure to expand the balloon, thereby stabilizing the tumor cavity.

[0025] (3) Through the present invention, a filling tube is connected to the degradable balloon, and the hydrogel can be refilled into the degradable balloon through the filling tube to expand it. The degradable balloon fills the aneurysm cavity to stabilize it and prevent the stent graft from having type I and type II endoleaks after surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 This is a schematic diagram of the structure of an arterial stent with an external expansion balloon on one side in Example 1 of the present utility model;

[0027] Figure 2 This is a schematic diagram of the structure of an arterial stent with external expansion balloons on both sides in Example 2 of the present utility model;

[0028] Figure 3 This is a schematic diagram of the structure of an arterial stent with an external expansion balloon and a pulling activation device in Example 3 of the present utility model;

[0029] Figure 4 for Figure 3 A schematic diagram of the enlarged structure of the suture pull line at point A in the middle;

[0030] Figure 5 This is a schematic structural diagram of an arterial stent with a filling tube connected to one side of the balloon in Example 4 of the present utility model;

[0031] Figure 6 This is a schematic structural diagram of an arterial stent in Example 5 of the present invention, in which both balloons on both sides are externally connected to filling tubes;

[0032] Figure 7 This is a schematic structural diagram of an arterial stent in Example 6 of the present invention, in which both balloons on both sides are externally connected to filling tubes;

[0033] Figure 8 This is a schematic structural diagram of the arterial stent in Example 1 of the present invention when applied to an aneurysm and before the hydrogel is released;

[0034] Figure 9 This is a schematic structural diagram of the arterial stent in Example 1 of the present invention after being applied to an aneurysm and the hydrogel is released;

[0035] Figure 10 This is a schematic structural diagram of the arterial stent in Example 3 of the present invention when applied to an aneurysm and before the hydrogel is released;

[0036] Figure 11 This is a schematic structural diagram of the arterial stent in Example 3 of the present invention after being applied to an aneurysm and the hydrogel is released;

[0037] Figure 12This is a schematic structural diagram of the arterial stent in Example 4 of the present utility model when applied to an aneurysm and before the hydrogel is released;

[0038] Figure 13 This is a schematic structural diagram of the arterial stent in Example 4 of the present invention after being applied in an aneurysm and the hydrogel is released.

[0039] In the figure: 100, covered stent; 101, bare crown; 102, support part; 200, biodegradable balloon; 201, connecting part; 300, hydrogel; 400, suture pull line; 500, filling tube; 600, aorta; 700, aneurysm; 701, aneurysm neck; 702, aneurysm wall; 703, aneurysm cavity; 800, thrombus. DETAILED DESCRIPTION

[0040] In order to make the technical means, creative features, objectives and effects of the present invention easier to understand, the present invention is further described below with reference to specific figures and embodiments.

[0041] The present invention provides an intraluminal aortic stent with an externally inflatable balloon. The stent includes a covered stent 100. A covered stent 100 is a metal stent coated with a special membrane material (such as polytetrafluoroethylene, Dacron, polyester, or polyurethane). While retaining the functionality of a metal stent, it also possesses the properties of a membrane material. Implanting the covered stent 100 within the aorta 600 isolates the aneurysm cavity 703 and reestablishes blood flow in situ.

[0042] Example 1:

[0043] like Figure 1As shown, the present invention makes innovations based on the original coated stent 100. The coated stent 100 is a woven coated stent 100. A strip-shaped degradable balloon 200 is provided on the outer side along one side of the length direction of the coated stent 100. The degradable balloon 200 is connected to the coated stent 100 by bonding. Specifically, medical gelatin is used to bond the degradable balloon 200 to the membrane of the coated stent 100. The medical gelatin can be absorbed by the human body after a period of time. The degradable balloon 200 is made of polylactic acid-glycolic acid copolymer. Polylactic acid-glycolic acid copolymer (poly(lactic-co-glycolic acid, PLGA) is formed by random polymerization of two monomers, lactic acid and glycolic acid. It is a degradable functional polymer organic compound with good biocompatibility, non-toxicity, and good capsule-forming and film-forming properties. The coated stent 100 consists of a bare crown portion 101 and a support portion 102 from top to bottom. The degradable balloon 200 is bonded to the support portion 102 of the coated stent 100 . The length of the degradable balloon 200 is roughly the same as that of the support portion 102 of the coated stent 100 .

[0044] The interior of the degradable balloon 200 is filled with hydrogel 300. The hydrogel 300 is made of glycopolypeptide hydrogel 300 and has good coagulation properties. The degradable balloon 200 will automatically degrade after entering the human body for a period of time, releasing the internal hydrogel 300. After being released, the hydrogel 300 enters the tumor cavity 703 and quickly combines with the blood in the tumor cavity 703 to form a thrombus 800, making the tumor cavity 703 thrombus 800 and thus stable.

[0045] Working principle:

[0046] like Figure 8 As shown, the stent graft 100 with an external expansion balloon in Example 1 of the present invention is implanted at the aneurysm 700 of the aorta 600. The aneurysm 700 includes a neck 701, a cavity 703, and a wall 702. The bare crown 101 of the stent graft 100 is anchored at the neck 701 of the aneurysm 700. The aneurysm 700 protrudes outward from one side of the aorta 600. Therefore, the side of the stent graft 100 with the degradable balloon 200 is directed toward the aneurysm 700 so that the degradable balloon 200 can be located in the cavity 703. Figure 9 As shown, the degradable balloon 200 will automatically degrade about 3 weeks after entering the human body, releasing the hydrogel 300 inside. After being released, the hydrogel 300 enters the tumor cavity 703 and quickly combines with the blood in the tumor cavity 703 to form a thrombus 800, making the tumor cavity 703 thrombus 800 and thus stable.

[0047] Example 2:

[0048] like Figure 2As shown, unlike Example 1, in this embodiment, a degradable balloon 200 filled with hydrogel 300 is bonded to both sides of the outside of the coated stent 100, and the two degradable balloons 200 are respectively distributed at the two ends of the circular diameter of the cross section of the coated stent 100. The degradable balloon 200 is arranged on one side of the coated stent 100 to target the bulge of the tumor cavity 703 on one side of the arterial blood vessel, and the degradable balloons 200 are arranged on both sides of the coated stent 100 to target the bulge of the tumor cavity 703 on both sides of the arterial blood vessel.

[0049] Example 3:

[0050] like Figure 3 and Figure 4 As shown, this embodiment 3 is improved on the basis of embodiment 1. A pulling start device is connected to the degradable balloon 200 for destroying the degradable balloon 200 and releasing the internal hydrogel 300. The pulling start device adopts a pull wire. Specifically, the pull wire is made of nickel-titanium alloy or polymer material. A suture pull wire 400 is reserved on the degradable balloon 200. The suture pull wire 400 will pull the distal end of the suture pull wire 400 outside the body to cause a crack in the main body of the degradable balloon 200, so that the internal hydrogel 300 can be released.

[0051] Working principle:

[0052] like Figure 10 As shown, the stent graft 100 with an external expansion balloon and a suture-type pull line 400 in Example 3 of the present invention is implanted into the aneurysm 700 of the aorta 600. The bare crown 101 of the stent graft 100 is anchored at the neck 701 of the aneurysm 700. The aneurysm 700 protrudes outward from one side of the aorta 600. The side of the stent graft 100 with the degradable balloon 200 is directed toward the aneurysm 700 so that the degradable balloon 200 can be located in the aneurysm cavity 703. Figure 11 As shown, after the stent is in place, the distal end of the external suture pull thread 400 is pulled from the outside to separate the proximal end of the suture pull thread 400 from the degradable balloon 200, causing a crack in the degradable balloon 200, and then blood from the outside enters and fills the balloon. The blood combines with the hydrogel 300 and expands, generating negative pressure to expand the balloon, thereby stabilizing the tumor cavity 703.

[0053] Example 4:

[0054] like Figure 5As shown, an improvement is made based on Example 1. A filling tube 500 is connected to the degradable balloon 200 for filling the interior of the degradable balloon 200 with hydrogel 300. If necessary during surgery (when Type I and Type II endoleaks are likely to occur), the filling tube 500 can be used to continuously fill the degradable balloon 200 with hydrogel 300, causing it to expand. The degradable balloon 200 fills the aneurysm 70 cavity, stabilizing it and preventing Type I and Type II endoleaks in the stent graft 100 after surgery. Type I endoleak involves the inability to seal the endograft attachment point to the native vessel. It is widely considered the most closely associated with rupture and the most aggressive to treat. Type I endoleak can occur at the proximal or distal attachment site and is associated with a short aneurysm 700 neck, large vessel diameter, an aneurysm 700 neck angle, and iliac artery curvature. Type II endoleak is the result of retrograde blood flow in small arteries such as the lumbar arteries or inferior mesenteric artery (IMA).

[0055] Working principle:

[0056] like Figure 12 As shown, the stent graft 100 with an external expansion balloon and a filling tube 500 in Example 4 of the present invention is implanted into the aneurysm 700 of the aorta 600. The bare crown 101 of the stent graft 100 is anchored at the neck 701 of the aneurysm 700. The aneurysm 700 protrudes outward from one side of the aorta 600. The side of the stent graft 100 with the degradable balloon 200 is directed toward the aneurysm 700 so that the degradable balloon 200 can be located in the aneurysm cavity 703. Figure 13 As shown, after the stent is in place, the hydrogel 300 is continuously filled into the degradable balloon 200 through the filling tube 500 connected to the syringe to expand it, as shown in FIG. Figure 13 As shown, the filled degradable balloon 200 expands to fill the aneurysm cavity 703 of the aneurysm 700 to stabilize it and prevent type I and type II endoleaks from occurring in the stent after surgery.

[0057] Example 5:

[0058] like Figure 6 As shown, for the bulges of the aneurysm cavity 703 on both sides of the arterial blood vessel, each degradable balloon 200 on both sides of the stent graft 100 is connected to a filling tube 500 for filling the interior of the degradable balloon 200 with hydrogel 300.

[0059] Example 6:

[0060] like Figure 7As shown, improvements are made on the basis of Example 5, by reducing one filling tube 500, and providing a connecting portion 201 between the degradable balloons 200 on both sides of the coated stent 100, with both ends of the connecting portion 201 being connected to the degradable balloons 200 on both sides respectively, and the connecting portion 201 and the degradable balloons 200 being made of the same material, and only one side of the degradable balloon 200 needs to be connected with a filling tube 500 to complete the filling of the degradable balloons 200 on both sides with the hydrogel 300.

[0061] The above text describes and illustrates the basic principles, main features, and advantages of the present invention. Those skilled in the art will appreciate that the present invention is not limited to the foregoing embodiments and that various modifications and improvements are possible without departing from the core content and scope of the present invention. Such modifications and improvements fall within the scope of protection claimed by the present invention. The scope of protection claimed by the present invention is defined by the appended claims and their equivalents.

Claims

1. An aortic intraluminal stent with an external expansion balloon, comprising a covered stent (100), characterized in that: At least one degradable balloon (200) is provided on the outside along the length direction of the coated stent (100), the interior of the degradable balloon (200) is filled with hydrogel (300), and the degradable balloon (200) is connected to a filling tube (500) for filling the interior of the degradable balloon (200) with hydrogel (300).

2. The aortic intraluminal stent with an external expansion balloon according to claim 1, characterized in that: A degradable balloon (200) filled with hydrogel (300) is provided on both sides of the exterior of the stent graft (100), and the two degradable balloons (200) are respectively distributed at the two ends of the cross-sectional diameter of the stent graft (100).

3. The aortic intraluminal stent with an external expansion balloon according to claim 1, characterized in that: The degradable balloon (200) is adhesively connected to the coated stent (100).

4. The aortic intraluminal stent with an external expansion balloon according to claim 1, characterized in that: The degradable balloon (200) is made of polylactic acid-glycolic acid copolymer.

5. The aortic intraluminal stent with an external expansion balloon according to claim 3, characterized in that: The stent graft (100) comprises a bare crown portion (101) and a support portion (102) from top to bottom, and the degradable balloon (200) is adhesively connected to the support portion (102) of the stent graft (100).

6. The aortic intraluminal stent with an external expansion balloon according to claim 1, characterized in that: The degradable balloon (200) is connected to a pulling activation device for destroying the degradable balloon (200) and releasing the internal hydrogel (300).

7. The aortic intraluminal stent with an external expansion balloon according to claim 6, characterized in that: The pulling activation device adopts a pull line, and a suture pull line (400) is reserved on the degradable balloon (200). The distal end of the suture pull line (400) outside the body is pulled to destroy the degradable balloon (200) and release the internal hydrogel (300).

8. The aortic intraluminal stent with an external expansion balloon according to claim 2, characterized in that: Each of the degradable balloons (200) is connected to a filling tube (500) for filling the interior of the degradable balloon (200) with the hydrogel (300).

9. The aortic intraluminal stent with an external expansion balloon according to claim 2, characterized in that: A connecting portion (201) is provided between the degradable balloons (200) on both sides of the coated stent (100), and both ends of the connecting portion (201) are respectively connected to the degradable balloons (200) on both sides, and a filling tube (500) is connected to one of the degradable balloons (200).

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