CN104997572B - A kind of dissection of aorta breach plugging device - Google Patents

Abstract

The present invention relates to technical field of medical instruments, the invention provides a kind of dissection of aorta breach plugging device, including bare bracket main body (1), collateral epitheca (2) and the closure that is compressed in collateral epitheca (2) are collateral (3)；Described closure collateral (3), which also includes turn (4) and turn microvillus (5) or described closure collateral (3), also includes steel wire (6) and spongy plug (7).The closure of the present invention is collateral to be fixed at interlayer breach and effectively blocks breach, stops that blood flow enters false chamber, induces false chamber thrombus organization and absorb.

Description

A kind of aortic dissection breach closure device

technical field

The invention relates to the technical field of medical devices, in particular to a occluding device for aortic dissection breach.

Background technique

Aortic dissection refers to the blood in the aortic lumen enters the aortic media from the aortic intima tear, separates the media, and expands along the long axis of the aorta, thus forming a true and false aortic cavity. a pathological change. The main harm is that the direct rupture of the false lumen or the rupture after the formation of an aneurysm will cause massive hemorrhage and death, and in the process of dissection formation, the formation of dissection is likely to interrupt the blood supply of important branches of the aorta, resulting in severe ischemia of important organs and even death. Loss of function, causing serious complications or death.

With the development of science and technology, the development of new materials and the innovation of micro-processing technology, minimally invasive surgical tools, such as vascular stent grafts, have appeared in clinical practice for the treatment of aortic dissection. The covered stent is based on a metal skeleton, and a layer of artificial vascular membrane is covered on the outside or inside of it. After the stent graft is delivered to the affected area, it will expand, and then cling to the intima of the blood vessel to seal the gap in the dissection, preventing the blood from continuing to enter the false lumen, so that the false lumen will gradually become thrombusized and absorbed mechanically. Clinically, in order to ensure that the covered stent can completely isolate the dissection gap, it is necessary to have a stent anchoring area of about 15 mm in length at the distal and proximal ends of the gap to avoid endoleak or stent displacement. It's like filling a hole in a piece of clothing with a patch. The patch must be larger than the hole itself to be sewn securely. However, when there are important branch arteries in the anchoring area of the stent, the covered stent will also isolate the adjacent branch arteries while isolating the dissection gap, which will lead to ischemia or even necrosis of the target organ. Therefore, for such a complex dissection in which the breach is adjacent to important branch arteries, there is an urgent clinical need for a dissection breach closure device that can target and seal the breach without affecting the adjacent branch arteries.

The Chinese patent number is CN201110208363.0, the publication number is CN102415909A, and the invention patents with priority numbers 61/365,9552010.07.20US and 13/170,8432011.06.28US disclose a false lumen occluder. The apparatus includes a plurality of struts, wherein at least one of the plurality of struts has a mid-strut portion having two or more secondary struts. The basic working principle of the invention is that after being compressed, it is delivered to the aortic opening through the delivery system, and then enters the false lumen through the aortic opening under the traction of the delivery system, and realizes the expansion of the occluder in the false lumen. It is bowed to form an arc, and the whole forms a fusiform shape. After expansion, it can well block the opening of the aortic dissection and form a thrombus in the false lumen, preventing blood from entering the false lumen. After the false lumen is occluded, the thrombus gradually organizes, and the occluder will shrink accordingly and stay in the media layer. However, this invention also has its drawbacks: firstly, the invention does not mention any means of fixing the rip occluder. At the breach of aortic dissection, high-speed blood flow flows from the true lumen through the breach into the false lumen. If the occluder cannot be effectively anchored at the breach, it is very likely that the occluder will be rushed into the false lumen by the blood flow, and its sharp The tip may cut through the wall of the false lumen and cause it to rupture, and the patient may die of hemorrhagic shock in a short period of time; secondly, the occluder proposed by this invention is released and expanded in the false lumen, and the sandwiched false lumen The wall is only a thin layer of media-adventitia of the aortic wall, and expansion in the false lumen itself has a certain risk of bursting the false lumen. Therefore, although this invention proposes the idea of targeting the closure of dissection clefts, there are obvious design deficiencies in clinical application. In order to isolate the dissection tear more safely and avoid excessive interference to the false lumen, we need to design a device that can effectively anchor at the dissection tear and release the occluder around the tear.

Contents of the invention

The purpose of the present invention is to realize the fixed blockage of side branches at the dissection opening and seal the aortic dissection opening, so as to prevent blood flow from entering the false lumen and gradually organize the thrombus in the false lumen.

The invention provides a kind of aortic dissection breach sealing device, and specific technical scheme is as follows:

Technical solution 1 of the present invention: an aortic dissection rip closure device, comprising a bare stent main body, a side branch sheath, and a side branch blocked in the side branch sheath;

The occluded side branch also includes coils and coil microvilli;

One end of the spring coil is anchored on the outer surface of the bare stent body through a connecting ring, and the microvilli of the spring coil is attached to the spring coil;

The second technical solution of the present invention: an aortic dissection breach closure device, comprising a bare stent main body, a side branch sheath, and a side branch that is compressed in the side branch sheath to occlude the side branch;

The side branch of the plugging also includes steel wire and sponge-like plugging;

One end of the steel wire is anchored on the outer surface of the bare stent main body through a connecting ring; the sponge-like plug is attached to the steel wire.

Preferably, on the outer surface of the bare stent main body, the distal and proximal ends where the connecting ring is located are provided with blocking positioning points.

Preferably, the outer edges of the distal and proximal ends of the bare stent body are respectively provided with a plurality of body positioning points.

Preferably, the outer end of the side branch outer sheath is connected with a traction guide wire.

In the present invention, a occluded side branch is carried on the basis of a bare stent main body. The main body of the bare stent not only acts as a carrier (that is, provides a platform for self-fixation for occluded side branches), but also plays a role in shaping the true lumen. The occluded side branch is fixed at the gap in the dissection and effectively seals the gap, preventing blood flow from entering the false lumen, and inducing the organization and absorption of the thrombus in the false lumen. At the same time, since the outer surface of the bare stent main body has the occlusion positioning point and the main body positioning point, a better visual field can be obtained under the angiography technique during the delivery process.

Description of drawings

Fig. 1 is the structural representation of embodiment 1 of the present invention, and wherein A is compressed state, and B is released state;

Fig. 2 is the structural representation of embodiment 2 of the present invention, wherein A is the compressed state, B is the release state;

The reference signs are: bare stent main body 1, side branch outer sheath 2, side branch blocking 3, spring coil 4, spring coil microvilli 5, steel wire 6, spongy blocking material 7, connecting ring 8, blocking positioning Point 9, subject positioning point 10.

detailed description

The aortic dissection breach occlusion device of the present invention will be further described in detail below in conjunction with the accompanying drawings.

Example 1:

As shown in Fig. 1, the present invention is a kind of aortic dissection breach occlusion device, comprises bare stent main body 1, side branch outer sheath 2 and the side branch 3 that is compressed in the side branch outer sheath 2; Support 3 also includes spring ring 4 and spring ring micro-villi 5; one end of spring ring 4 is anchored on the outer surface of bare stent body 1 by connecting ring 8; spring ring micro-villi 5 is attached to spring ring 4; bare stent body On the outer surface of the outer surface of the connecting ring 8, the far and near ends of the position where the connecting ring 8 is located are provided with a blockage positioning point 9; the outer edge of the far and near end of the bare stent main body 1 is respectively provided with four main body positioning points 10; Guide wire 11.

Among them, the bare stent main body 1 can be made by laser engraving technology or braiding process; the side branch sheath 2 can adopt a slender circular tubular structure, and the caliber size of the spring coil 4 is larger than the caliber size of the side branch sheath 2 in the natural state. The slender side branch outer sheath 2 in the state makes the coil 4 deform, and the spring coil 4 is compressed into the side branch outer sheath 2; the traction guide wire 11 here has been connected to the outer end of the side branch outer sheath 2 at the selected product stage , but not limited thereto, the traction guide wire can also be temporarily connected to the outer end of the side branch sheath 2 before the operation starts.

When in use, the bare stent main body 1 is first compressed on a control guide wire of the delivery system, and then the side branch sheath 2, the blocked side branch 3 compressed in the side branch sheath 2, the bare stent main body 1 and the side branch The traction guide wire 11 connected to the outer end of the branch outer sheath 2 is compressed into the main body outer sheath of the delivery system together as a whole. At this time, since the side branch outer sheath 2 and the spring coil 4 are connected by the anchoring method of the connecting ring 8, the anchoring The spring coil 4 on the outer surface of the bare stent main body 1 has a certain degree of mobility, which can avoid the breakage or deformation of the occluded side branch 3 in the process of overall compression; Introduce into the true lumen of the aortic lesion, and observe the anchor point 10 of the main body under DSA (Digital SubtractionAngiography). At this time, the main body of the bare stent 1 is still tied to the control guide wire, and continue to adjust the occluded side branch 3 to the aortic dissection breach by observing the occluded positioning point 9 under DSA, and then pull the side branch 3 through the traction guide wire 11. The outer sheath 2 and the occluded side branch 3 are guided into the false lumen of the dissection. At that time, the control guide wire is withdrawn to release the main body 1 of the bare stent, and finally the side branch outer sheath 2 is retracted to release the occluded side branch 3. The coil 4 returns to the natural state before being compressed under the action of its own elastic force, and at the same time, the microvilli 5 of the coil coil are opened, and the coil 4 and the microvilli 5 of the coil coil work together in the false lumen to block the opening of the aortic dissection and block blood flow. The flow into the false lumen induces organization and absorption of the false lumen thrombus.

Example 2:

As shown in Fig. 2, the present invention is a kind of aortic dissection breach occlusion device, comprises bare stent main body 1, side branch outer sheath 2 and is compressed in side branch outer sheath 2 to occlude side branch 3; The branch 3 also includes a steel wire 6 and a spongy plug 7 ; one end of the steel wire 6 is anchored to the outer surface of the bare stent body 1 through a connecting ring 8 ; the spongy plug 7 is attached to the steel wire 6 .

Among them, the bare stent main body 1 can be made by laser engraving technology or weaving process; the side branch sheath 2 adopts a slender circular tubular structure, and the sponge-like blockage 7 is short and thick in the natural state, and its diameter is larger than that of the side branch sheath 2, the spongy occluder 7 is compressed in the side sheath 2 in the compressed state; the spongy occluder 7 can be made of medical high-resilience materials, such as high-density polyvinyl alcohol sponge.

When in use, first connect the traction guide wire 11 to the side branch sheath 2, compress the bare stent main body 1 on a control guide wire of the delivery system, and then compress the side branch sheath 2 and the side branch sheath 2 The occluded side branch 3, the bare stent main body 1, and the traction guide wire 11 connected to the outer end of the side branch sheath 2 are compressed into the main body sheath of the delivery system together as a whole. The anchoring method of the connecting ring 8 is used to connect, so the spring ring 4 anchored on the outer surface of the bare stent main body 1 has a certain degree of mobility, which can avoid the fracture or deformation of the side branch 3 during the overall compression; Next, the compressed whole is introduced into the true cavity of the aortic lesion through the femoral artery or other peripheral arteries, observed under DSA, and the outer sheath of the main body is released. At this time, the main body of the bare stent 1 is still tied to the control guide wire, and then guided Guided by the wire 11, the side branch outer sheath 2 and the blocked side branch 3 pass through the opening of the aortic dissection and enter the false lumen of the dissection. At that time, the guide wire is withdrawn to release the bare stent main body 1, and finally the side branch outer sheath 2 is withdrawn to release the sealed stent. Blocking the side branch 3, the spongy plug 7 for blocking the side branch 3 is in the false lumen, and due to its own elastic force, it returns to a short and thick shape, blocking the opening of the aortic dissection, preventing blood flow from entering the false lumen, and inducing false lumen thrombus Organize and absorb.

Example 3:

An aortic dissection breach closure device, the rest of which are the same as in Example 2. The patient's aortic dissection breach is located at the 5 mm distal end of the left subclavian artery, the breach diameter is 3 mm, and the diameter of the proximal aneurysm neck is 35 mm.

In order to obtain sufficient radial force to anchor on the inner wall of the blood vessel after the bare stent body 1 is released, the caliber of the bare stent body should exceed the diameter of the proximal aneurysm neck by 10%-20%, so the bare stent body 1 with a caliber of 40mm is selected. In order to make the caliber of the spongy occluder 7 larger than the diameter of the aortic dissection breach after release, select the spongy occluder 7 with a caliber of 6mm in the natural state; in order to make the side branch outer sheath 2 pass through the aortic dissection breach smoothly , choose the side branch outer sheath 2 with a caliber of 2.5mm; since the side branch 3 is anchored to the outer surface of the bare stent body 1 through the connecting ring 8, it is not necessary to consider the side branch 3 in the interlayer The problem of fixation in the false lumen, at the same time, the bare stent body 1 has a shaping effect on the blood vessel; the combination of the blocked side branch 3 and the bare stent body 1 can effectively fix the blocked side branch 3 to the aortic dissection gap and effectively block it The gap blocks the blood flow into the false lumen and induces the organization and absorption of the false lumen thrombus.

The preferred embodiments of the present invention have been specifically described above, but the present invention is not limited to the described embodiments, and those skilled in the art can also make various equivalents without violating the spirit of the present invention. Modifications or replacements, these equivalent modifications or replacements are all included within the scope defined by the claims of the present application.

Claims (3)

1. A kind of 1. dissection of aorta breach plugging device, it is characterised in that it include bare bracket main body (1), collateral epitheca (2) with And the closure being compressed in collateral epitheca (2) is collateral (3)；

   Described closure collateral (3) also includes turn (4) and turn microvillus (5), or described closure collateral (3) is also wrapped Include steel wire (6) and spongy plug (7)；

   Described turn (4) its one end is anchored to the outer surface of bare bracket main body (1), described spring by connection ring (8) Circle microvillus (5) is attached on turn (4)；

   Described steel wire (6) one end is anchored to the outer surface of bare bracket main body (1) by connection ring (8)；Described spongy envelope Stifled thing (7) is attached on steel wire (6)；

   The far and near end of connection ring (8) position is provided with closure anchor point (9) on the outer surface of bare bracket main body (1).
2. 2. a kind of dissection of aorta breach plugging device as claimed in claim 1, it is characterised in that bare bracket main body (1) Far and near end outer rim is respectively provided with multiple agent localization points (10).
3. A kind of 3. dissection of aorta breach plugging device as claimed in claim 1, it is characterised in that described collateral epitheca (2) outer end, it is connected with traction seal wire (11).