CN105662650A - Integrated coated branched vascular stent and conveying system thereof - Google Patents

Abstract

The invention relates to an integrated film-covered branch vessel stent and a delivery system thereof. The main body and branches of the stent are designed in one piece, and the main body and branches of the stent have integrated coating materials, which can reduce the incidence of endoleak after stent implantation; the front end of the main body of the stent is a bare stent part, which can strengthen anchoring The edge of the stent's main stent and the connection between the main stent and the branch stent have platinum-iridium alloy development points, which enable the stent to dynamically monitor the position of the stent during the release process, achieving the purpose of precise positioning and release. The fixation and release of the stent adopts a bundled design, which maximizes the compression of the stent and securely fixes it, reduces the diameter of the conveyor, and facilitates long-distance transportation and operation; the delivery system adopts a segmented release method to solve the problem of existing stent release In the process, it is easy to shift, and the bracket can no longer be adjusted, so it has a good market application prospect.

Description

Integrated covered branch vessel stent and its delivery system

technical field

The invention relates to the field of medical devices, in particular to an integrated film-covered branch vessel stent and a delivery system thereof.

Background technique

Aortic aneurysm is a global common disease that is extremely harmful to human health and has a high mortality rate. Traditional surgery involves large injuries, many complications, and high mortality. Moreover, there are still a large number of patients who are difficult to perform surgical treatment because of the dysfunction of other important organs. Endoluminal aortic aneurysmrepair (EAAR) was first proposed in 1991. In recent years, with the rapid development of interventional radiology technology and equipment, endovascular aneurysm repair (EVAR) has gradually matured. Compared with traditional surgery, it has the advantages of no thoracotomy, no laparotomy, less trauma, fewer surgical complications, shorter hospital stay, and wide indications. It has become the first choice for clinical treatment of such diseases, especially high-risk patients. Methods, and applied to the endovascular repair of thoracic aortic aneurysm and thoracic aortic dissection (thoracicendovascularaneurysmrepair, TEVAR). Although EVAR has many advantages mentioned above and the incidence of systemic complications is low (accounting for 12%), however, it is limited in the treatment of thoracic aortic aneurysms.

Reason 1. Since thoracic aortic aneurysm may involve important vascular branches on the aortic arch (left subclavian artery, left common carotid artery, and right brachiocephalic trunk), TEVAR treatment is likely to face difficulties due to the short neck of the aneurysm or the location of the first incision. Too close to the supra-arched branch arteries can lead to the embarrassment that occlusion cannot be performed or incomplete occlusion, and Stanford type A dissecting aneurysms are considered to be contraindications for TEVAR. In recent years, TEVAR combined with chimney technique or debranching method has been used as a complementary approach to TEVAR for thoracic aortic aneurysms with such anatomical characteristics that cannot accept surgical aortic arch replacement. However, the chimney technique will inevitably lead to postoperative endoleak problems, resulting in poor long-term efficacy, and devascularized branch aortic arch upper branch vascular bypass grafting increases the difficulty and degree of trauma of the operation, which may increase the risk of cerebrovascular accidents. incidence rate. The second reason is that due to the curvature of the aortic arch, if the anchoring area is too short or the curvature of the aortic arch is too large after the stent graft is implanted, persistent endoleaks will easily form on the greater and lesser curvatures. The third reason is the expansion of the anchoring area of the aneurysm neck with similar pathophysiological features to the early aneurysm, the lack of histological healing between the stent-graft and the vessel wall of the aneurysm neck, and the straight cylindrical stent-graft in the curved aortic arch. Displacement and detachment of the stent due to inconformity. The incidence rate of the latter two complications can reach 30%, which will lead to the failure of clinical treatment of this high-tech and high-priced (150,000-200,000 yuan/case) TEVAR, which limits the clinical application and development of TEVAR.

Contents of the invention

The object of the present invention is to provide an integrated covered branch vessel stent and a delivery system thereof. The stent can be used to treat aortic dissection and true and false aneurysms involving the ascending aorta, aortic arch, and/or proximal descending aorta, and the branch stent is anchored in the branch of the superior arch artery to improve the effectiveness of the covered vascular stent. The stability and reduce the incidence of stent displacement.

An integrated covered branch stent, comprising a main body stent, a branch stent connected to the main body stent, and a covered graft sutured on the main body stent and the branch stent. Iridium alloy development point.

Further, the main body and the branches of the stent of the present invention are integrated, and the membrane graft is also integrated.

The platinum-iridium alloy development point enables the stent to dynamically monitor the position of the stent during the release process, achieving the purpose of precise release.

Further, the integrated covered branch vessel stent is a metal stent. Preferably, the metal stent is made of stainless steel or memory nickel-titanium alloy, and the graft graft is made of flexible polymer materials, preferably polyester (PET), polytetrafluoroethylene (PTFE), etc., and sutured with polyester sutures on a metal stand.

Further, the stent is bent into multiple wave patterns from stainless steel or memory nickel-titanium alloy to form a hollow skeleton of the stent. The waveform can be stretched horizontally or undulated vertically, so that the diameter or length of the stent can be changed and adjusted, so that the stent fits more closely with the blood vessel and reduces the risk of endoleak.

Further, the integrated covered branch vessel stent also includes a bare stent located at the top of the main body stent. The bare stent is located at one end of the main body stent and has the same diameter as the main body stent, and the other end has a diameter larger than that of the main body stent. The bare stent is bent into multiple wave patterns by stainless steel or memory nickel-titanium alloy to form a hollow skeleton of the stent, and there is no graft on the bare stent.

Further, the main body bracket and the branch bracket form a certain angle. Preferably, the angle is not a right angle. More preferably, the angle between the main body stent and the branch stent is the same as the angle between the aortic arch and the upward branch of the convex side of the aortic arch.

In the existing stents with branches, both the branch stent and the main body stent are at 90-degree right angles or no specific angle is designed, which leads to passive adaptation to the direction of the branches of the aortic arch after the stent is released, and at the same time causes changes in the direction of the branch vessels, causing side effects, such as stents Adhesion problems with the arterial wall, causing endoleaks, etc.

The present invention first determines the angles between the aortic arch and the innominate artery (brachiocephalic trunk), the angle between the left common carotid artery and the left subclavian artery through techniques such as angiography and CTA. Secondly, determine the number of branch stents and the location of the branch stents according to the patient's condition: 1-3 branch stents; the branch stents are connected to the innominate artery and/or the left common carotid artery and/or the left subclavian artery. Finally, a stent in which the angle of the main body stent and the branch stent is the same as that of the aortic arch and the upward branch from the convex side of the aortic arch is prepared.

Furthermore, the one-piece covered branch vascular stent is sterilized with ethylene oxide and is disposable.

The purpose of the present invention is to provide a delivery system for an integrated covered branch vessel stent, which includes the outermost outer sleeve. The outer sleeve includes 3 parts, a front part, a middle part and a rear part, a delivery rod and a main body guide located inside the delivery rod. The wire is used to compress the binding wire of the stent. The interior of the delivery rod contains 1-7 branch catheters, and each branch catheter runs through a branch guide wire or binding wire.

Branch catheters allow each branch guidewire and tie wire to have its own conduit and path within the delivery rod. In view of the problems that the guide wire and the guide wire, the guide wire and the binding wire, the binding wire and the binding wire are intertwined and knotted in the existing stent, the respective pipelines and paths of the branch guide wire and the binding wire are designed in the delivery rod, and the While solving existing problems, it is easy to operate.

Further, the delivery system releases the integrated covered branch vessel stent in a segmented release manner. The segmented release means that the branch stent is released first, and then the main body stent is released. Preferably, the segmented release means that the branch stent is released first, then the main body stent is released, and finally the bare stent at the top is released.

The outer casing consists of 3 parts, the front part, the middle part and the rear part. The front part mainly wraps the bare bracket, the middle part mainly wraps the branch bracket, and the rear part wraps the main bracket. The stent is released in sections. First, untie the middle part of the outer sleeve to release the branch bracket, then untie the rear end of the outer sleeve to release the main bracket, and finally untie the front end of the outer sleeve to release the bare stent at the top.

The binding wire includes several parts, the binding wire of the main body bracket, and the binding wires of the branch brackets respectively binding each branch bracket. In the process of segmental release, untie the middle part of the outer casing, pull the binding wires of the branch brackets, and release the branch brackets respectively; then untie the rear part of the outer casing, pull the binding wires of the main bracket, and release the main bracket , in order to prevent the stent from shifting due to blood flow impact, etc., the bare stent adopts the post-release technology, and finally the front part of the outer sleeve is untied to release the bare stent.

In view of the two problems in the existing stent release process, first, if the bare stent at the head end is released first, the position of the stent cannot be adjusted after release. Second, if the stent is made of metal mesh, it is in a compressed state in the conveyor. Due to the longitudinal retraction force of the stent when the stent is released, the stent is shortened and the blood flow is impacted, which makes the stent prone to misalignment. Accurate, even shifting; the invention creatively improves the delivery system, adopts segmental release stents, first releases the branch stent, then releases the main body stent, and finally releases the bare stent at the head end; releases the branch stent first, so that the stent can be released It is more firmly anchored at the aortic arch, reducing the incidence of displacement; finally releasing the front-end bare stent can further strengthen the anchoring and overcome the inconvenience and defects of the prior art.

Specific operation steps: Under general anesthesia, ventilator-assisted ventilation, the person is in the supine position, the skin is cut layer by layer at the femoral artery to expose the femoral artery, and a blocking band is set on the upper and lower ends of the free artery, and after tightening , make a small incision on the free segment of the artery, send it into the stent delivery system, send the delivery system to the aortic arch under the guidance of the main body guide wire, and send each branch stent into each branch of the aortic arch under the guidance of the branch guide wire After accurate positioning, pull the binding wire, release the branch stents respectively, and then release the main stent. In order to prevent the stent from shifting due to blood flow impact, etc., the bare stent adopts post-release technology, and finally releases the bare stent. After all the stents are released, contrast catheter angiography is used to determine the position and opening degree of the stent, and decide whether to perform post-dilation according to the situation.

Optimum operation steps: Under general anesthesia, ventilator-assisted ventilation, the person is in the supine position, the skin is cut layer by layer at the femoral artery to expose the femoral artery, and a blocking band is placed on the upper and lower ends of the free artery, and after tightening , make a small incision on the free segment of the artery, send it into the stent delivery system, and send the delivery system to the aortic arch under the guidance of the main body guide wire, untie the middle part of the outer sleeve, and place each branch stent under the guidance of the branch guide wire. Send it into each branch of the aortic arch, and after accurate positioning, pull the binding wires of the branch stents to release the branch stents respectively, then untie the rear end of the outer sleeve, pull the binding wires of the main body stent, and release the main body stents. Displacement caused by blood flow impact, etc., the bare stent adopts post-release technology, and finally the front part of the outer sleeve is untied to release the bare stent. Due to the memory of the memory nickel-titanium alloy, after the stent is released, it can perfectly match with the aortic arch and the branch stents from the convex side of the aortic arch. After all the stents are released, angiography is performed with an angiography catheter to determine the position and opening degree of the stent, and decide whether to proceed according to the situation. after expansion.

Description of drawings

Figure 1 is a diagram of an integrated covered branch vascular stent with one branch

Figure 2 is a diagram of an integrated covered branch vascular stent with two branches

Figure 3 is a diagram of an integrated covered branch vascular stent with three branches

Figure 4 is an illustration of the platinum-iridium alloy development point of the one-piece covered branch vessel stent

Figure 5 is a delivery system diagram of the integrated covered branch vessel stent

Figure 6 is a partial enlarged view of the delivery system of the integrated covered branch vessel stent

Figure 7 is a partial view of the integrated covered branch vessel stent and its delivery system

Figure 8 is a combination diagram of the integrated covered branch vessel stent and its delivery system

Figure 9 is a rear view of the delivery system of the integrated covered branch vessel stent

Explanation of reference signs:

1 main body stent; 2 branch stent; 3 covered graft; 4 bare stent; 5 outer cannula; 51 front part; 52 middle part; 7 delivery rods; 81 main body guide wires; 82 branch guide wires; 9 branch catheters; 10 platinum-iridium alloy development points.

detailed description

The present invention will be further elaborated below in conjunction with specific examples, which are only used to explain the present invention, and should not be construed as limiting the present invention. Those skilled in the art can understand that: without departing from the principle and purpose of the present invention, various changes, modifications, replacements and modifications can be made to these embodiments, and the scope of the present invention is defined by the claims and their equivalents. For the experimental methods that do not indicate specific conditions in the following examples, the detection is usually carried out according to conventional conditions or according to the conditions suggested by the manufacturer.

Example 1

An integrated covered branch vessel stent, comprising a main body stent 1, a branch stent 2 connected to the main body stent 1, and a covered graft 3 sutured on the main body stent 1 and the branch stent 2, the edge of the main body stent 1 and the main body stent 1 There is a platinum-iridium alloy development point 10 at the connection with the branch bracket 2 .

The delivery system of the integrated covered branch vessel stent includes the outermost outer sleeve 5, the outer sleeve includes 3 parts, the front part 51, the middle part 52 and the rear part 52, the binding wire 6 for compressing the stent, and the delivery rod 7 And the main body guide wire 81 located inside the delivery rod 7 , the delivery rod contains 1-7 branch catheters, and each branch catheter runs through a branch guide wire or binding wire 6 .

Specific operation steps: Under general anesthesia, ventilator-assisted ventilation, the person is in the supine position, the skin is cut layer by layer at the femoral artery to expose the femoral artery, and a blocking band is set on the upper and lower ends of the free artery, and after tightening , make a small incision on the free section artery, send it into the stent delivery system, send the delivery system to the aortic arch under the guidance of the main body guide wire 81, and send each branch stent to the aortic arch under the guidance of the branch guide wire 82. In the branch, after accurate positioning, pull the binding wire 6, release the branch brackets 2 respectively, and then release the main bracket 1. After all the stents are released, contrast catheter angiography is used to determine the position and opening degree of the stent, and decide whether to perform post-dilation according to the situation.

Example 2

First, the angles between the aortic arch and the innominate artery (brachiocephalic trunk), the angle between the left common carotid artery and the left subclavian artery were determined by angiography, CTA and other techniques.

Secondly, determine the number of branch stents 2 and the position of branch stents 2 according to the needs of the patient: 1-3 branch stents; the branch stent 2 is connected to the innominate artery and/or the left common carotid artery and/or the left subclavian artery.

Finally, the angle between the main body stent 1 and the branch stent 2 is the same as that of the branch angle from the convex side of the aortic arch, and the obtained integrated covered branch vessel stent includes the main body stent 1 and the branch stent 2 connected with the main body stent 1 , the angles of the two are the same as the branch angles from the convex side of the aortic arch, and the graft 3 sutured on the stent has a platinum-iridium alloy development point 10 on the edge of the main body stent 1 and the connection between the main body stent 1 and the branch stent 2 .

Example 3

First, the angles between the aortic arch and the innominate artery (brachiocephalic trunk), the angle between the left common carotid artery and the left subclavian artery were determined by angiography, CTA and other techniques. The aortic model or aneurysm model produced by 3D printing analyzes the angles of each branch to further optimize the shape, size, and angle of the branch stent.

Secondly, determine the number of branch stents 2 and the position of branch stents 2 according to the needs of the patient: 1-3 branch stents; the branch stent 2 is connected to the innominate artery and/or the left common carotid artery and/or the left subclavian artery.

Finally, the main body stent 1 and the branch stent 2 have the same angle as the branch angle from the convex side of the aortic arch through 3D printing technology. The obtained integrated covered branch vessel stent includes the main body stent 1 The bare stent 4 at the top, the branch stent 2 connected with the main body stent 1, the angle between the main body stent 1 and the branch stent 2 is the same as the angle of the branch upward from the convex side of the aortic arch, and the membrane sutured on the main body stent 1 and the branch stent 2 The graft 3 has platinum-iridium alloy development points 10 on the edge of the main body stent 1 and at the junction of the main body stent 1 and the branch stent 2 .

The delivery system of the integrated covered branch vessel stent includes the outermost outer sleeve 5, the outer sleeve includes 3 parts, the front part 51, the middle part 52 and the rear part 52, the binding wire 6 for binding the compressed stent, the delivery rod 7 and the main body guide wire 81 located inside the delivery rod 7, which contains 1-7 branch catheters 9, each of which runs through a branch guide wire 82 or binding wire 6.

Specific operation steps: Under general anesthesia, ventilator-assisted ventilation, the person is in the supine position, the skin is cut layer by layer at the femoral artery to expose the femoral artery, and a blocking band is set on the upper and lower ends of the free artery, and after tightening , make a small incision on the free segment of the artery, send it into the stent delivery system, send the delivery system to the aortic arch under the guidance of the main body guide wire 81, and send each branch to each branch of the aortic arch under the guidance of the branch guide wire 82 Inside, after accurate positioning, pull the binding wire 6, release the branch stent 2 respectively, and then release the main stent 1, in order to prevent the stent from shifting due to blood flow impact, etc., the bare stent 4 adopts post-release technology, and finally releases the bare stent 4. After all the stents are released, contrast catheter angiography is used to determine the position and opening degree of the stent, and decide whether to perform post-dilation according to the situation.

Example 4

First, the angles between the aortic arch and the innominate artery (brachiocephalic trunk), the angle between the left common carotid artery and the left subclavian artery were determined by angiography, CTA and other techniques.

Secondly, determine the number of branch stents 2 and the position of the branch stents 2 according to the needs of the patient: 1-3 branch stents 2; the branch stents 2 are connected to the innominate artery and/or the left common carotid artery and/or the left subclavian artery.

Finally, the main body stent 1 and the branch stent 2 have the same angle as the branch angle from the convex side of the aortic arch through 3D printing technology. The obtained integrated covered branch vessel stent includes the main body stent 1 The bare stent 4 at the top, the branch stent 2 connected with the main body stent 1, the angle between the main body stent 1 and the branch stent 2 is the same as the angle of the branch upward from the convex side of the aortic arch, and the membrane sutured on the main body stent 1 and the branch stent 2 The graft 3 has platinum-iridium alloy development points 10 on the edge of the main body stent 1 and at the junction of the main body stent 1 and the branch stent 2 .

The delivery system of the integrated covered branch vessel stent includes the outermost outer sleeve 5, the outer sleeve includes 3 parts, the front part 51, the middle part 52 and the rear part 52, the binding wire 6 for binding the compressed stent, the delivery rod 7 and the main body guide wire 81 located inside the delivery rod 7, which contains 1-7 branch catheters, and each branch catheter runs through a branch guide wire 82 or binding wire 6. The outer sleeve 5 includes three parts, a front part 51 , a middle part 52 and a rear part 52 . The front part 51 mainly wraps the bare bracket 4 and the top part of the main bracket 1 , the middle part 52 mainly wraps the branch bracket 2 , and the rear part 52 wraps the main bracket 1 behind the branch bracket 2 . The binding wire 6 includes several parts, a main body support binding line 61, and a branch support binding line 62 binding each branch support. The bracket is released in sections, first untie the middle part 52 of the outer sleeve 5, release the branch bracket 2, untie the rear end part 52 of the outer sleeve 5, release the rear part of the main bracket 1, and finally untie the front part 51 of the outer sleeve 5 , release the main body bracket 1 and bare bracket 4 at the top.

Specific operation steps: Under general anesthesia, ventilator-assisted ventilation, the person is in the supine position, the skin is cut layer by layer at the femoral artery to expose the femoral artery, and a blocking band is set on the upper and lower ends of the free artery, and after tightening , make a small incision on the free segment of the artery, send it into the stent delivery system, and send the delivery system to the aortic arch under the guidance of the main body guide wire 81, untie the middle part 52 of the outer sleeve 5, and guide it under the guidance of the branch guide wire 82 Send each branch into each branch of the aortic arch, after accurate positioning, pull the branch stent binding wire 62, release the branch stent 2 respectively, untie the rear end part 52 of the outer sleeve 5, pull the main body stent binding wire 61, and The main body stent 1 is released. In order to prevent the stent from shifting due to blood flow impact, etc., the bare stent 4 adopts the post-release technology, and finally the front end part 51 of the outer sleeve 5 is untied to release the bare stent 4 . Due to the memory of the memory nickel-titanium alloy, after the stent is released, it can perfectly match with the aortic arch and the branch stents from the convex side of the aortic arch. After all the stents are released, angiography is performed with an angiography catheter to determine the position and opening degree of the stent, and decide whether to proceed according to the situation. after expansion.

It should be noted that, in the specific implementation cases of the integrated covered branch vessel stent and its delivery system provided by the present invention, the sequence of segmental release of the stent can be changed according to the specific situation. After the main stent is deployed, the branch stents are released. The embodiments of the present invention are only used for explaining the present invention, and should not be construed as limiting the present invention.

Claims (10)

1. integral type overlay film branch vessel support, the branch stent being connected with main body rack including main body rack and the overlay film graft being sewn on main body rack and branch stent, it is characterized in that, main body rack edge and main body rack and branch stent junction develop a little with platinumiridio.

2. integral type overlay film branch vessel support according to claim 1, it is characterised in that integral type overlay film branch vessel support also includes the bare bracket being positioned at main body rack top.

3. integral type overlay film branch vessel support according to claim 1, it is characterised in that the angle on-right angle that main body rack and branch stent are formed.

4. integral type overlay film branch vessel support according to claim 1, it is characterised in that the angle that main body rack is formed with branch stent is identical with the convex Branch Angle sent on the side of aortic arch Yu aortic arch. Main body rack and the angle of branch stent is prepared with the identical support of the convex Branch Angle sent on the side of aortic arch Yu aortic arch preferably by 3D printing technique.

5. integral type overlay film branch vessel support according to claim 1, it is characterised in that integral type overlay film branch vessel support is metal rack, it is preferred that metal rack is made up of rustless steel or memory nitinol.

6. integral type overlay film branch vessel support according to claim 5, it is characterised in that curved multiple waveform patterns by rustless steel or memory nitinol and form the hollow member of support.

7. the induction system of integral type overlay film branch vessel support, including outmost trocar sheath, conveying lever and be positioned at the seal wire within conveying lever, for bundling the lashing wire of compressed stent, it is characterized in that, trocar sheath comprises 3 parts, fore-end, mid portion and rear end part, comprise 1-7 brasnch conduct inside conveying lever, each brasnch conduct runs through branch's seal wire or lashing wire.

8. the induction system of integral type overlay film branch vessel support according to claim 7, it is characterised in that induction system adopts the mode of releasing by parts to discharge integral type overlay film branch vessel support.

9. the induction system of integral type overlay film branch vessel support according to claim 7, it is characterized in that, trocar sheath comprises 3 parts, fore-end, mid portion and rear end part, fore-end mainly wraps up bare bracket, mid portion mainly wraps up branch stent, rear end part parcel main body rack.

10. the induction system of integral type overlay film branch vessel support according to claim 7, it is characterised in that lashing wire includes several part, main body rack lashing wire, bundlees the branch stent lashing wire of each branch stent respectively.