CN217772586U - Aortic arch branch type covered stent - Google Patents

Abstract

The utility model relates to an aortic arch branch type tectorial membrane stent, which consists of a main body stent and a branch stent, wherein the main body stent and the branch stent are both composed of a plurality of metal spring stent rings and tectorial membranes; the main body support is designed in an integrated manner, a keel is arranged on the large bent side of the main body support, and the main body support structurally comprises a near-end anchoring structure, a far-end anchoring structure, a middle branch support embedded area and three embedded branches embedded in the inner wall of the main body support; the branch support is provided with three. The utility model is used for the multiple aortic arch portion pathological change of clinical patient of treatment, it is convenient to take, can improve the promptness and the success rate of operation.

Description

A kind of aortic arch branch type covered stent graft

technical field

The utility model relates to the technical field of medical devices, in particular to an aortic arch branch type covered stent.

Background technique

After the aorta of the human body is issued from the heart, it first ascends (ascending aorta) and bends downward in an arc (aortic arch), and migrates to the descending aorta at the lower edge of the fourth thoracic vertebra. From the convex side of the aortic arch, three important branch vessels supply the head and upper extremities, which are divided into innominate artery, left common carotid artery and left subclavian artery from right to left.

Traditional thoracotomy for the treatment of aortic arch lesions (aortic arch aneurysm, aortic dissection, penetrating aortic ulcer, etc.) involves large trauma, high mortality and complication rates, and is difficult for poor or elderly patients to tolerate. Endovascular aortic repair with stent-grafts has become the first-line treatment for aortic lesions that do not involve branch vessels, with minimal trauma and definite effects. However, the use of endovascular techniques in aortic arch lesions is limited due to issues related to branch revascularization. Endovascular reconstruction of supraaortic arch branches mainly includes chimney technique, fenestration technique and branch stent technique.

The chimney technique is on the outside of the main covered stent. The chimney stent is compressed and occluded and has a high risk of internal leakage. It is often used as a remedial measure when the upper branch of the aortic arch is accidentally blocked during surgery, and it cannot be used as a conventional technique. The fenestration technique uses the existing aortic stent graft, and the doctor "opens" the window on the stent graft according to the specific anatomy to reconstruct the branch blood vessels. However, this fenestration destroys the original structure of the stent-graft, leading to an increase in the long-term stent-graft fracture rate and a high risk of endoleak at the window site. More importantly, this modified stent-graft does not conform to medical standards. ethical requirements.

Branch stent technology, the existing branched stent grafts of the aortic arch need to be individually customized, and the customization cycle is often as long as three months, which limits the use in emergency situations; Due to the distorted shape of the diseased aortic arch, the endovascular reconstruction of the aortic arch is faced with a series of problems such as the inability to fully deploy the branch stent, the rotation of the position of the branch stent, the difficulty of superselecting the branch arteries, and the folding of the main stent in the shape of a bird's beak. Meet the treatment of aortic arch lesions.

Utility model content

The purpose of the utility model is to provide a convenient aortic arch branch-type covered stent for clinical treatment of patients with various aortic arch lesions, so as to improve the timeliness and success rate of the operation.

The utility model is realized in this way. It is composed of two parts, the main body bracket and the branch bracket. Both the main body bracket and the branch bracket are composed of several metal spring bracket rings and coatings; There is a keel, and the structure includes the proximal anchoring structure, the distal anchoring structure, the middle branch bracket embedded area, and three embedded branches embedded in the inner wall of the main bracket, the proximal anchoring structure, the distal On the edge of the anchoring structure, there are marking points for developing the proximal end of the main stent and developing marking points for the distal end of the main stent. The diameter of the anchoring structure at the proximal end is larger than the embedded area of the branch stent in the middle; The diameter of the proximal end is 13mm, corresponding to the first embedded branch on the inner wall of the main stent, the proximal diameter of the second branch stent is 8mm, corresponding to the second embedded branch on the inner wall of the main stent, and the proximal diameter of the third branch stent 8mm, corresponding to the third embedded branch on the inner wall of the main body bracket.

The peak-trough distance of the first, second and sixth metal spring support rings of the main body support is fixed at 16mm; the third-sixth metal spring support rings are designed to be non-uniform, and the specific , the top end is four metal spring support rings with a peak-valley distance of 16mm, and the bottom end is five metal spring support rings with a peak-valley distance of 12mm.

The embedded area of the branch bracket refers to the middle part of the main body bracket, and the outer window development mark ring is buried at the corresponding outer window of the three embedded branches, and the embedded branch is embedded with the corresponding inner window. The inner window develops the marking point, and the diameter of the embedded area is smaller than that of the proximal anchoring structure, and its diameter is constant at 28 mm.

The embedded branch refers to the bracket branch embedded in the inner wall of the main body bracket. The branch is fixed on the inner wall of the main body bracket, parallel to the long axis of the main body bracket, and has a trumpet-shaped opening outward; the inner window of the embedded branch is circular , and has a developing marking point, and the embedded length is designed to be 2cm, giving sufficient anchoring length to the connected branch bracket.

There are three embedded branches, the first embedded branch has a diameter of 12mm, and the second embedded branch has a diameter of 7mm. The first and second embedded branches are respectively located on both sides of the keel at the top of the main frame. The inner window is located on the inner surface of the first and second metal spring support rings of the main body bracket, the embedded branch extends backward along the long axis of the main body bracket, and the outer window is located on the center line of the concave area on the top surface of the embedded area of the branch bracket in the middle section of the main body bracket The outer window is trumpet-shaped, the inner window has a development mark point, and the outer window has a development mark ring; the third embedded branch has a diameter of 7mm, and its inner opening faces the distal end of the main bracket. It is a reverse design. The window is located on the seventh metal spring support ring of the main body support, extends forward to the sixth metal spring support ring and opens on the outer surface of the main support, and the inner and outer windows are provided with development mark points and development mark rings, the embedded branch A guide wire with a diameter of 0.018 inches is preset inside.

The length of the branch stent is 8cm or 10cm, the diameter of the tail end of the first branch stent is 14mm or 16mm, and the diameter of the tail end of the second and third branch stents is 6mm and 8mm.

The distance between the crest and trough of the metal spring bracket ring of the branch bracket is 6mm, and the head end and the tail end of the branch bracket are provided with developing marking points.

The covering material of the main body bracket and the branch bracket is polytetrafluoroethylene (ePTFE), and the metal spring bracket ring is made of nickel-titanium memory alloy.

The utility model has the following advantages:

1. The main body stent adopts an integrated design and has different models, which can adapt to the anatomical shape of the aorta of most patients, and is easy to commercialize and mass-produce without individual customization.

2. The main stent adopts an integrated design, which avoids the risk of internal leakage caused by the modular design and the risk of pressure occlusion of the embedded branch stent, and has no effect on cerebral blood flow during implementation, and does not need to establish a bypass in advance for brain protection .

3. There is a keel on the major curvature side of the main stent, so that the main stent can only bend to the opposite side (the lesser curvature side of the aortic arch), which can avoid shortening and twisting on the side of the embedded branch of the main stent; the outer opening of the embedded branch adopts a bell mouth The design, supplemented by the imaging marking ring, is convenient for reconstruction through the innominate artery and the left common carotid artery; the embedded branches fully ensure the overlapping length of the branch stents and avoid endoleak; the third-sixth metal spring stents of the main stent The ring adopts an uneven design, and the metal spring support ring at the top of the main stent adopts a large ring design, which enhances the support force of the main stent on the greater curvature of the aortic arch. It adapts to the curvature of the aortic arch, increases the adherence of the stent, and avoids the "bird's beak" phenomenon of malapposition of the stent, so as to achieve a better therapeutic effect.

Description of drawings

Fig. 1 is a three-dimensional structure schematic diagram of the present utility model.

Fig. 2 is a side view of the main frame structure of the present invention.

Fig. 3 is a top view of the main frame structure of the present invention.

Fig. 4 is a schematic diagram of the structure of the branch bracket of the present invention.

Fig. 5 is a schematic diagram of the three-dimensional structure of the utility model when it is implemented in the aortic arch of a human body.

Description of figure number:

Main body bracket--1 Branch bracket--2 Metal spring bracket ring--3

Membrane--4 Proximal Anchoring Structure--5 Distal Anchoring Structure--6

Embedded area of branch stent--7 Embedded branch--8,9,10

Keel--11 The third-sixth metal spring bracket ring--12

Outer window developer marking ring -- 13, 14, 15

Inner Window Development Marking Points--16, 17, 18 Branch Bracket Metal Spring Bracket Ring--19

Visualization markers at the proximal end of the main body stent--20 Visualization markers at the distal end of the main body stent--21

The development mark point at the head end of the branch stent--22, the development mark point at the tail end of the branch stent--23

Detailed ways

Below in conjunction with accompanying drawing and embodiment the utility model is described further.

Refer to Fig. 1-shown in Fig. 5, the utility model is made up of two parts of main body support 1 and branch support 2, and main body support 1 and branch support 2 are all made up of several metal spring support rings 3 and coating film 4; Main body support 1 is an integrated design, and a keel 11 is provided on the greater curvature side, so that the main body stent 1 can only be bent to the opposite side of the keel 11, so as to prevent the main body stent 1 from being shortened, rotated, or twisted at the aortic arch.

The structure of the main body stent 1 includes a proximal anchoring structure 5, a distal anchoring structure 6, a branch stent embedded area 7 in the middle, and three embedded branches 8, 9, 10 embedded in the inner wall of the main body stent. The edges of the anchoring structure 5 and the distal anchoring structure 6 are provided with the proximal development marking point 20 of the main body bracket and the distal development marking point 21 of the main body bracket. In order to attach to the wall of the aortic arch, this part can be attached (or not attached) with cilia and barbs to enhance its adherence.

There are three branch stents 2, the proximal diameter of the first branch stent is 13 mm, which corresponds to the first embedded branch 8 on the inner wall of the main body stent 1, and is used to reconstruct the innominate artery, and the proximal diameter of the second branch stent is 8 mm. The second embedded branch 9 corresponding to the inner wall of the main body stent 1 is used for reconstruction of the common carotid artery, the third branch stent has a proximal diameter of 8 mm, and the third embedded branch 10 corresponding to the inner wall of the main body stent is used for reconstruction Left subclavian artery.

The peak-to-trough distance of the first, second and sixth metal spring bracket rings 3 of the main body bracket 1 is fixed at 16mm; the third-sixth metal spring bracket rings 3 are designed to be non-uniform, and the specific , the top is four metal spring support rings 3 with a peak-to-trough distance of 16mm, and the bottom is five metal spring support rings with a peak-to-valley distance of 12mm. Adapts to the curved shape of the aortic arch, reducing the risk of malapposition or beak formation.

The embedded area 7 of the branch bracket refers to the middle part of the main body bracket, which is embedded with the outer window development mark ring 13, 14, 15 corresponding to the three embedded branches 8, 9, 10, and the embedded branch 8 , 9, 10 are buried with inner window development markers 16, 17, 18 at the corresponding inner window for intraoperative positioning. The diameter of the embedded area 7 of the branch stent is smaller than that of the anchoring structure 5 at the proximal end, and its diameter is constant at 28 mm, so as to reserve a certain space for superselection of the branch stent 2 during operation.

Embedded branches 8, 9, and 10 refer to the bracket branches embedded in the inner wall of the main body bracket 1. The branches are fixed on the inner wall of the main body bracket 1, parallel to the long axis of the main body bracket, and have a trumpet-shaped opening outward, with a developing mark on the opening Rings 13, 14, 15; the inner windows of the embedded branches 8, 9, 10 are circular, and there are developed marking points 16, 17, 18, and the embedded length is designed to be 2cm, so as to give sufficient anchoring to the connected branch brackets length. During the operation, after the main body stent 1 is opened, the embedded branches 8, 9, 10 are opened accordingly, and the guide wire catheter can be super-selected into the embedded branches 8, 9, 10 through the outer window, and then connected to the branch stent 2, supplying corresponding branch vessels.

There are three embedded branches 8, 9, and 10. The first embedded branch 8 has a diameter of 12 mm and is used to reconstruct the innominate artery, and the second embedded branch 9 has a diameter of 7 mm and is used to reconstruct the common carotid artery. , the first and second embedded branches 8 and 9 are respectively located on both sides of the top keel 11 of the main body support 1, and the inner windows are located on the inner surfaces of the first and second metal spring support rings 3 of the main body support 1, and the embedded branches 8, 9 extend backward along the long axis of the main body bracket, the outer window is located on both sides of the centerline of the top surface recessed area of the embedded area 7 of the branch bracket in the middle section of the main body bracket, the outer window is trumpet-shaped, and the inner window has a developing mark point 16 , 17, there are developing mark rings 13,14 at the outer window. The third embedded branch 10 has a diameter of 7 mm and is used to reconstruct the left subclavian artery. Its inner window faces the distal end of the main body stent and is designed in reverse. The inner window is located on the seventh metal spring stent ring 3 of the main body stent 1 and faces forward Extending to the sixth metal spring bracket ring 3 and opening on the outer surface of the main body bracket 1, the inner and outer windows are provided with a development mark point 18 and a development mark ring 15, and a guide with a diameter of 0.018 inches is preset in the embedded branch. The wire has three functions: ①Provide traction force to assist in delivering the stent to the lesion; ②Provide traction force and at the same time ensure that the side of the embedded branch of the main stent faces the branch vessels of the aortic arch, preventing the main stent from rotating; ③Because the third branch is retrograde, a reserved guide wire can simplify the reconstruction of the left subclavian artery.

The embedded branch stents 8 , 9 , and 10 can supply blood to the three branch vessels on the aortic arch immediately after deployment, and have no effect on cerebral blood flow during the operation, and no carotid artery bypass protection is required in advance.

The length of the branch stent 2 is 8cm and 10cm, the diameter of the tail end of the first branch stent (corresponding to the innominate artery) is 14mm and 16mm, and the diameter of the tail end of the second and third branch stents (corresponding to the left common carotid artery and the left subclavian artery respectively) is 6mm and 8mm.

The distance between the crest and trough of the metal spring support ring 19 of the branch support 2 is 6mm, and the head end and the tail end of the branch support 2 are provided with developing marking points 22, 23 for guiding the positioning of the branch support.

The main frame 1 and the branch frame 2 cover 4 are made of polytetrafluoroethylene (ePTFE), which has good biological compatibility. The cover material can be directly pressed together with the metal spring support ring to avoid pinhole blood leakage caused by sewing risk, while also smoothing the inner surface of the main body stent graft.

The metal spring support ring 3 is made of nickel-titanium memory alloy, which has a shape memory effect. After the processing is completed, it can be folded and shrunk in the release sheath of 22-24F, which is convenient for entering the aorta through the femoral artery approach. After reaching the predetermined position, it can be removed from the It is released from the sheath and returns to its original shape.

The main body stent 1 adopts the design of embedded branches. On the one hand, the overlapping length of the branch stents is increased to reduce the risk of internal leakage; on the other hand, the embedded branches of the main body stent are easier to expand to avoid the risk of branch compression.

The two ends of the main body stent 1 are designed with different diameter specifications, which are more suitable for the diameters of the anchoring areas of the ascending aorta and the descending thoracic aorta.

Proximal and distal anchoring structures 5 and 6 of the main body stent are provided with a proximal development mark point 20 and a distal development mark point 21 for positioning the stent under X-ray fluoroscopy.

The main body stent 1 adopts an integrated design without customization, and adapts to the patient's anatomy. The proximal and distal diameters of the main body stent are set to different diameters, and the proximal diameters (including but not limited to) are 32mm, 36mm, 40mm, 42mm, 45m and There are six specifications of 50mm, and four specifications of distal end diameter (including but not limited to) 24mm, 28mm, 32mm, and 35mm.

The third-sixth metal spring bracket ring 12 in the middle section of the main body bracket is the embedded area 7 of the branch bracket. The top of the bracket is designed as a concave step shape with a total length of 8 cm. At the end and the distal end, the diameter of the embedded area is fixed at 28mm. This design is convenient for the superselection of the branch stent after the release of the main stent, and the deployment of the branch stent after the release of the branch stent to avoid entanglement or compression occlusion between the branch stents.

Further, the three embedded branches 8, 9, and 10 of the main body bracket 1 are all 2 cm in length, fixed on the inner surface of the main body bracket 1, and their distal ends are sewed to the outer window opened on the upper wall of the main body bracket. The inner windows of type branches 8, 9, 10 are circular and have development marking points.

When applying the utility model, the operation steps are as follows:

Temporary pacing leads were placed transvenously into the right ventricle.

Incision was made to expose bilateral carotid arteries, bilateral carotid artery access was established, femoral artery and left upper limb artery access were established, superhard guide wire was sent through femoral artery to ascending aorta, catheter was sent through upper limb artery approach and Pulled out from the femoral artery, the preset guide wire of the left subclavian artery of the main body stent is fed into the catheter and pulled out through the upper limb path to establish a stretch guide wire, and then introduced into the main body stent 1 through the superhard guide wire of the femoral artery.

Use the marking points on the main body stent 1, the perspective view of the keel 11, and the preset guide wire of the third embedded branch to perform axial positioning to ensure that the embedded branches 8, 9, and 10 are located on the side of the opening of the upper branch of the aortic arch. Ensure accurate axial positioning.

Angiography was used to clarify the opening position of the upper branch of the aortic arch. The outer window rings of the embedded branches 8 and 9 were located near the opening of the innominate artery and the left common carotid artery. Before releasing the main body stent, the arterial systolic pressure should be controlled below 100mmHg.

The main body stent 1 is released, and at this time, the embedded branches 8 and 9 are deployed accordingly, which can supply blood to the branches on the aortic arch and avoid the occurrence of cerebral ischemia. The design of the keel 11 of the main body stent can assist the positioning of the opening of the branch, avoiding the shortening and displacement of the stent when it is released; it can avoid the rotation of the stent when it is released, and keep the embedded branch facing the opening of the innominate artery and the left common carotid artery.

After the main body stent is released, the guide wire catheter is sent through the right carotid artery, and according to the guidance of the outer window developing ring 13, super-selected into the first embedded branch 8 of the main body stent, and the guide wire is sent into the main body stent through the left carotid artery. Guided by the outer window developing ring 14, the catheter superselects and enters the second embedded branch 9 of the main body bracket. Send the branch stents into the first and second embedded branches 8 and 9 through the bilateral carotid artery route respectively, and the developing marking point 22 at the head end of the branching stent 2 and the developing marking point 16 at the inner window of the embedded branches 8 and 9 , 17 are overlapped, and the branch brackets are released sequentially.

After the stent reconstruction of the innominate artery and the left common carotid artery branch was completed, the main body stent release system was removed, and the pre-set guide wire from the third embedded branch to the left subclavian artery was retained, and the branch stent was sent to the third internal artery through the femoral artery approach. In the embedded branch 10, the developed marking point 23 at the tail end of the branch stent 2 coincides with the developed marking point 18 of the inner window of the third embedded branch 10, and the stent is released to reconstruct the left subclavian artery.

After all the branches are reconstructed, a balloon dilation catheter needs to be sent to expand the overlapping parts of each branch stent and the embedded branch to enhance the adhesion between the stents.

Claims (8)

1. An aortic arch branch type tectorial membrane stent is characterized by comprising a main stent and a branch stent, wherein the main stent and the branch stent are both composed of a plurality of metal spring stent rings and tectorial membranes; the main body support is designed in an integrated manner, a keel is arranged on the large bent side of the main body support, the main body support structurally comprises a near-end anchoring structure, a far-end anchoring structure, a middle branch support embedded area and three embedded branches embedded in the inner wall of the main body support, a main body support near-end developing mark point and a main body support far-end developing mark point are arranged on the edges of the near-end anchoring structure and the far-end anchoring structure, and the diameter of the near-end anchoring structure support is larger than that of the middle branch support embedded area; the diameter of the near end of the first branch support is 13mm, the diameter of the near end of the first branch support corresponds to the first embedded branch of the inner wall of the main body support, the diameter of the near end of the second branch support is 8mm, the diameter of the near end of the second embedded branch corresponds to the second embedded branch of the inner wall of the main body support, and the diameter of the near end of the third branch support is 8mm, and the diameter of the near end of the third branch support corresponds to the third embedded branch of the inner wall of the main body support.

2. The aortic arch branch type stent graft of claim 1, wherein the first, second and sixth metal spring stent rings of the main stent have a fixed peak-to-valley distance of 16mm, the third and sixth metal spring stent rings are designed to be non-uniform, specifically, four metal spring stent rings with a peak-to-valley distance of 16mm are provided at the top, and five metal spring stent rings with a peak-to-valley distance of 12mm are provided at the bottom.

3. The aortic arch branch type stent graft of claim 1, wherein the branch stent graft embedded region is a middle portion of the main stent, and is formed by embedding an outer window development mark ring at an outer window corresponding to the three embedded branches, and embedding an inner window development mark point at an inner window corresponding to the embedded branches, and the diameter of the embedded region is smaller than that of the anchoring structure at the near end and is constant at 28mm.

4. The aortic arch branch type stent graft of claim 1, wherein the embedded branch is a branch embedded in the inner wall of the main stent body, and the branch is fixed on the inner wall of the main stent body, parallel to the long axis of the main stent body and flared outwards; the inner window of the embedded branch is circular and is provided with a developing mark point, the embedded length is designed to be 2cm, and the embedded branch is provided with enough anchoring length for the connected branch support.

5. The aortic arch branch type covered stent of claim 1, wherein the embedded branches are three, the diameter of the first embedded branch is 12mm, the diameter of the second embedded branch is 7mm, the first embedded branch and the second embedded branch are respectively positioned at two sides of a keel at the top end of the main stent, the inner windows are positioned at the inner surfaces of the first metal spring stent ring and the second metal spring stent ring of the main stent, the embedded branches extend backwards along the long axis direction of the main stent, the outer windows are positioned at two sides of the central line of the top surface of the embedded area of the branch stent at the middle section of the main stent, the outer windows are horn-shaped, the inner windows are provided with developing mark points, and the outer windows are provided with developing mark rings; the diameter of the third embedded branch is 7mm, the inner opening of the third embedded branch faces the far end of the main body support and is reverse in design, the inner window is located in a seventh metal spring support ring of the main body support, the third embedded branch extends forwards to the sixth metal spring support ring and is opened on the outer surface of the main body support, the inner window and the outer window are provided with developing mark points and developing mark rings, and a guide wire with the diameter of 0.018 inch is preset in the embedded branch.

6. The aortic arch branch type covered stent according to claim 1, wherein the branch stents have a length of 8cm or 10cm, the diameter of the tail end of the first branch stent is 14mm or 16mm, and the diameters of the tail ends of the second and third branch stents are 6mm and 8mm.

7. The aortic arch branch type stent graft according to claim 1, wherein the distance between the peak and the trough of the metal spring stent ring of the branch stent is 6mm, and the head end and the tail end of the branch stent are provided with developing mark points.

8. The aortic arch branching type stent graft as claimed in claim 1, wherein the third to sixth metal spring stent rings in the middle section of the main stent, i.e. the branch stent embedded region, have a stepped concave shape at the top end and a total length of 8cm.

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