CN114404105A - Covered stent, blood channel repairing assembly and method for expanding covered stent - Google Patents

Abstract

The invention provides a covered stent, a blood channel repairing assembly and a method for opening the covered stent. The channel repairing assembly comprises the covered stent. In the invention, the temporary operation space provides a temporary blood flow channel for membrane rupture and hole opening, so that the condition that a branch blood vessel is closed by a membrane for a long time in an operation to cause ischemia of organs such as a brain and the like is prevented, the temporary operation space increases the operation space for operating a guide wire and a sheath tube to pass through the hole opening, and the difficulty of a doctor in operation is reduced.

Description

Covered stent, blood channel repairing assembly and method for expanding covered stent

Technical Field

The invention relates to a medical apparatus, in particular to a covered stent, a blood channel repairing assembly and a method for opening the covered stent.

Background

Aortic Dissection (AD) is a disease in which the intima and media of the blood vessel of a diseased Aortic region are separated, and Aortic endoluminal repair is a minimally invasive interventional therapy, in the process of treating Aortic Dissection by Aortic endoluminal repair, a vascular artificial tubular prosthesis (i.e., a stent graft) is released at the diseased vascular region by percutaneous puncture and a specific delivery device, and the ruptured intima is sealed by the artificial prosthesis to reconstruct a new blood channel, so as to isolate the impact of high-pressure blood flow of the aorta on the diseased region, thereby realizing the treatment of the Aortic Dissection. The aortic endoluminal repair has smaller wound than open surgery and has the advantages of better long-term aortic remodeling and the like compared with conservative treatment.

The aortic arch is the part of the aorta which is in bow-shaped bending, and three larger arterial branches are arranged at the side of the major bend. Three major branch vessels are innominate artery, left common carotid artery and left subclavian artery in sequence from proximal to distal along aorta. When the aortic dissection involved in the aortic arch is treated in the cavity, the covered stent needs to cover and cross the aortic arch.

When the traditional covered stent is used for aortic dissection repair, the covered stent is firstly inserted into an aortic arch, then a membrane breaking device such as a membrane breaking needle is used for breaking a membrane and opening a hole on the covered stent, and then a guide wire passes through the hole from a branch blood vessel or an aortic side access to guide the delivery and release of the branch stent; alternatively, a parallel stent technique may be employed, in which a stent graft is inserted into the aortic arch and a parallel stent graft is inserted to communicate the aorta and the branch vessels, so as to establish branch channels juxtaposed to the internal channels of the stent graft.

The traditional covered stent has the following defects:

1. if the stent graft is not provided with a preset opening, the branch blood vessel is sealed by the coating on the stent graft during rupture of the membrane, and if the sealing time is too long, blood supply of organs such as the brain and the like during operation may be insufficient.

2. The guide wire is not easy to pass through a membrane rupture hole, the size and the position of the arch part branch blood vessel often limit the flexibility of the guide wire, and the operation difficulty of a doctor in operation is large.

Disclosure of Invention

In view of the above, the main objective of the present invention is to provide a stent graft, a blood channel repairing assembly and a stent graft expanding method, so as to reduce the operation difficulty of a doctor during operation.

In order to achieve the above and other related objects, the present invention provides a stent graft, which includes a support body and a cover membrane, wherein the support body includes a support frame, the cover membrane is attached to the support frame, the cover membrane is separated from the support frame inwards along a local area of the stent graft in the circumferential direction to form an inward-concave cover membrane, the inward-concave cover membrane is located at one end of the stent graft, and a temporary operating space is formed between the inward-concave cover membrane and the support frame outside the inward-concave cover membrane.

In some embodiments of the present invention, the support body further includes a pre-concave frame, the pre-concave frame includes a support portion and a pre-concave portion, the support portion and the pre-concave portion are circumferentially disposed, the inner concave covered membrane is attached to the pre-concave portion, the covered membrane, which is located at the same axial position as the inner concave covered membrane, is attached to the support portion, and the pre-concave portion can be expanded or expanded to be reset along a radial direction of the covered stent, so that a cross section of the covered stent is fixed to be circular.

In some embodiments of the present invention, the support frame includes a plurality of support rings arranged at intervals along an axial direction of the stent graft, the support rings are supported at both ends of the stent graft, and the cover membrane is separated from the support ring at one end inwards along a local circumferential region of the stent graft to form the concave cover membrane; the pre-concave frame comprises at least one pre-concave ring arranged along the axial direction of the covered stent, each pre-concave ring comprises an outer arch section and an inner concave section which are connected along the circumferential direction of the covered stent, the outer arch section forms the supporting part, and the inner concave section forms the pre-concave part.

In some embodiments of the present invention, the support ring corresponding to the end of the stent graft where the concave covering membrane is located is a concave section support ring, a part of the concave section support ring is attached with the covering membrane, and a part of the concave section support ring is not attached with the covering membrane.

In some embodiments of the present invention, the number of the pre-recessed rings is one, and the pre-recessed rings are disposed between two of the concave segment support rings closest to one end of the stent graft and are axially spaced apart from adjacent concave segment support rings.

In some embodiments of the invention, the number of the pre-recessed rings is at least two, and each of the pre-recessed rings is disposed between two of the inner recessed segment support rings nearest to one end of the stent graft and is axially spaced apart from an adjacent inner recessed segment support ring.

In some embodiments of the present invention, the number of the pre-concave rings is at least two, and each of the pre-concave rings and the inner concave section support ring are alternately arranged at intervals along the axial direction of the stent graft.

In some embodiments of the invention, the support ring undulates axially, and the pre-groove ring undulates axially.

In some embodiments of the invention, the peaks or troughs of the recessed segments are more dense than the peaks or troughs of the support ring, and the height of the recessed segments in the axial direction is less than the height of the support ring in the axial direction.

In some embodiments of the invention, the cover film includes a main body cover film and the recessed cover film, the main body cover film being attached to the support frame and to the support portion of the pre-recessed frame.

In some embodiments of the invention, the concave cover film is attached to an inner surface of the pre-recess, and the main body cover film is attached to an inner surface of the support frame.

In some embodiments of the invention, the concave membrane is attached to an inner surface of the pre-recess and the main membrane is attached to an outer surface of the support frame.

In some embodiments of the present invention, the concave cover film is attached to an inner surface of the pre-recess, and the main body cover film includes an outer cover film attached to an outer surface of the support frame and an inner cover film attached to an inner surface of the support frame.

In some embodiments of the present invention, the cross-sectional area of the pre-concave frame is greater than or equal to half of the cross-sectional area of the support frame.

In some embodiments of the invention, the length of the concave covering membrane in the axial direction ranges from 20mm to 80 mm.

In some embodiments of the present invention, the distance between two adjacent support rings is greater than 0 and less than 20 mm.

In some embodiments of the invention, the spacing between two adjacent support rings is in the range of 2-6 mm.

Accordingly, the present invention also provides a blood channel repair assembly comprising:

a stent graft as any one of the above-described stent grafts;

and the opening piece is used for opening the concave covered membrane in the covered stent, so that the cross section of the covered stent is fixed to be circular.

In some embodiments of the invention, the stent is a bare stent.

Accordingly, the present invention also provides another blood passage repair set comprising:

the covered stent is any one of the covered stents provided with the support ring and the pre-concave ring; (ii) a

The supporting ring at the outermost end of the covered stent, which is separated from the concave covered membrane, is a traction supporting ring, and one end of the traction wire bypasses the traction supporting ring from the covered stent and then returns to the covered stent, so that the traction wire is hooked on the part, which is not attached with the covered membrane, of the traction supporting ring;

tightening the pulling wire by pulling both ends of the pulling wire;

and (3) inward radial stretching of the traction line leads the local part of the traction stent ring to be internally buckled in the concave tectorial membrane, and then the traction line is released to outwards jack the concave section of the pre-concave ring and the concave tectorial membrane, so that the cross section of the tectorial membrane stent is completely deformed to be circular.

Correspondingly, the invention also provides a method for strutting the covered stent, the covered stent is any one of the covered stents which is provided with the support ring and the pre-concave ring,

the support ring at which the outermost end of the covered stent is separated from the concave covered membrane is a traction support ring; the distraction method comprises the following steps:

before the stent graft is inserted, a traction wire is configured, one end of the traction wire is wound around the traction support ring from the inside of the stent graft and then returns to the inside of the stent graft, so that the traction wire is hooked on the part, which is not attached with a coating, on the traction support ring;

after the covered stent is inserted and released, the pulling wire is tightened by tensioning the two ends of the pulling wire, the pulling wire is inwards pulled along the radial direction to enable the local part of the pulling stent ring to be internally buckled in the concave covered film, then the pulling wire is released, the concave section of the pre-concave ring and the concave covered film are outwards pushed open, and the cross section of the covered stent is completely deformed to be circular.

Accordingly, the present invention also provides a blood channel repair assembly comprising:

a stent graft as any one of the above-described stent grafts;

a parallel stent for establishing a branch channel juxtaposed to the stent graft internal channel,

the parallel stent passes through the part, which is not attached with the tectorial membrane, of the support frame, so that part of the branch sections of the parallel stent are positioned in the temporary operation space, and part of the branch sections are positioned outside the tectorial membrane stent.

As described above, the present invention has the following advantageous effects:

in the invention, the temporary operation space provides a temporary blood flow channel for membrane rupture and hole opening, which is beneficial to avoiding the condition that the branch blood vessel is closed by the membrane for a long time in the operation to cause ischemia of organs such as brain, and the temporary operation space is increased, and the temporary operation space increases the operation space for operating the guide wire and the sheath tube to pass through the hole opening, thereby reducing the difficulty of the doctor in operation.

Drawings

FIG. 1a is an elevation view of one embodiment of a peritoneal stent of the present invention;

FIG. 1b is a schematic sectional view taken along line A-A of the stent graft of FIG. 1 a;

FIG. 1c is a top view of the stent graft of FIG. 1 a;

FIG. 1d is an exploded view of the stent graft of FIG. 1a exploded into a support body and a cover;

FIG. 1e is a three-dimensional structural view of a support body in the stent graft of FIG. 1 a;

FIG. 1f is an exploded view of the holder body of FIG. 1e exploded into a support frame and a pre-concave frame;

FIG. 1g is a three-dimensional structural view of the stent graft of FIG. 1 a;

FIG. 1h is an exploded view of the stent graft of FIG. 1g, exploded with or without a cover attached;

FIG. 2a is an elevation view of another embodiment of a peritoneal stent of the present invention;

FIG. 2b is a schematic sectional view of the stent graft of FIG. 2a taken along line A-A;

FIG. 3 is an elevation view of another embodiment of a peritoneal stent of the present invention;

FIG. 4 is an elevation view of another embodiment of a peritoneal stent of the present invention;

FIG. 5a is a three-dimensional structural view of one embodiment of a support ring of the present invention;

FIG. 5b is an expanded view of the support ring of FIG. 5a in a flat expanded configuration;

FIG. 6a is a three-dimensional structural view of one embodiment of a pre-recessed ring of the present invention;

FIG. 6b is an expanded view of the planar expansion of the pre-recessed ring of FIG. 6 a;

FIG. 7a is a schematic view of a conventional stent graft after rupture of the membrane and opening of the guidewire;

FIG. 7b is a schematic view of the guidewire delivery after the stent graft of the present invention has been ruptured and fenestrated;

FIG. 8a is a schematic view of a stent of the present invention prior to release within a stent graft;

FIG. 8b is a schematic view of a stent of the present invention partially released within a stent graft;

FIG. 8c is a schematic view of the stent of the present invention after it has been fully released within the stent graft;

FIG. 9a is a schematic view of a pulling wire of the present invention hanging from a pulling support ring;

FIG. 9b is a schematic view of the pulling wire of FIG. 9a being pulled to tighten the pulling wire;

FIG. 9c is a schematic view after the puller wire in 9b is radially cantilevered outward and the pre-recessed ring is expanded;

FIG. 10 is a schematic view of a stent graft of the present invention in use with a parallel stent.

Description of reference numerals

A support body 100, a first branch section a, a second branch section B, a third branch section C;

the support frame 110, the first frame part 110a, the second frame part 110b, the support ring 111, the pulling support ring 111a, the support section 1111, and the hollow section 1112;

pre-concave frame 120, support portion 120a, pre-concave portion 120b, pre-concave ring 121, outer arch section 1211, inner concave section 1212;

a covering film 200, an inward concave covering film 210 and a main body covering film 220;

a temporary operating space M;

a spreader 300;

aortic arch 401, innominate artery 402, left common carotid artery 403, left subclavian artery 404;

a guidewire 500;

a pull wire 600;

a temporary support 700; a rupture pin 800.

Detailed Description

The embodiments of the present invention are described below with reference to specific embodiments, and other advantages and effects of the present invention will be easily understood by those skilled in the art from the disclosure of the present specification. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention.

Please refer to fig. 1 a-9 c. It should be noted that the drawings provided in the present embodiment are only for illustrating the basic idea of the present invention, and the components related to the present invention are only shown in the drawings rather than drawn according to the number, shape and size of the components in actual implementation, and the type, quantity and proportion of the components in actual implementation may be changed freely, and the layout of the components may be more complicated.

For convenience of description, the terms appearing herein are to be construed:

small bending: a blood vessel, a stent, or the like is a quasi-circular tube, and when it is bent, the side having a smaller bending radius is a small bent side.

Large bending: blood vessels, stents, and the like are similar to a circular tube, and when they are bent, the side having a larger bending radius is a large-bent side.

Proximal end: the arterial blood vessels from the heart gradually branch into capillaries and then gradually merge into venous blood vessels back to the heart, wherein the end of any segment of the blood vessels close to the heart is called the proximal end.

Distal end: the arterial blood vessel from the heart gradually branches into capillaries and then gradually merges into venous blood vessels to return to the heart, wherein the end of any section of the blood vessel far away from the heart is called the far end.

Axial direction: blood vessels, interventional stents, and the like are all quasi-tubular, and if they are considered as cylinders, the cylindrical rotation axis is defined as the axial direction.

Radial: the radial direction is perpendicular to the axial direction, namely the radius or diameter direction of the end face circle of the cylinder, and the radial direction is perpendicular to the axial space.

Circumferential direction: "circumferential" or circumferential, which together with "axial" and "radial" constitute the three orthogonal directions of the cylindrical coordinates.

The invention provides a covered stent, and fig. 1a, fig. 2a, fig. 3, fig. 4 each show a schematic structural view of a covered stent, and with reference to fig. 1a and fig. 1d, the covered stent of the invention includes a support main body 100 and a covering membrane 200, with reference to fig. 1e and fig. 1f, the support main body 100 includes a support frame 110, with reference to fig. 1a to fig. 1f, the covering membrane 200 is attached to the support frame 110, the covering membrane 200 is separated from the support frame 110 inwards along a local region in the circumferential direction of the covered stent to form an inner concave covering membrane 210, the inner concave covering membrane 210 is located at one end of the covered stent, and a temporary operating space M is formed between the inner concave covering membrane 210 and the support frame 110 outside the inner concave covering membrane 210.

In the present invention, the cover film 200 is made of a flexible film material, and may be made of PET (Polyethylene terephthalate, polyester fiber, or polyester fiber) or EPTFE (expanded polytetrafluoroethylene). The cover film 200 may be attached to the corresponding position of the support body 100 by means of sewing or heat-melting, etc.

Fig. 7b shows a schematic view of the stent graft applied to the aortic endoluminal procedure, and fig. 7b shows the introduction of a guide wire or a branch stent into the innominate artery 402 as an example, but the stent graft of the present invention can be substantially applied to the case where a guide wire 500 is introduced from one or two or three branch arteries among the innominate artery 402, the left common carotid artery 403 and the left subclavian artery 404.

For convenience of explanation, the two ends of the stent graft are defined according to the orientation of the stent graft to be inserted into the aortic arch 401, and in the following description, one end of the stent graft provided with the concave cover 210 is defined as a proximal end, and the other end of the stent graft is defined as a distal end.

Referring to fig. 7a, when the aortic lumen is repaired, if the concave covering membrane is not provided, the size of the branch vessel is limited, the guide wire is not easy to pass through the opening, the operation difficulty is high, and the branch vessel is sealed by the covered stent, which may cause cerebral ischemia.

With reference to fig. 1a to fig. 1f and fig. 7b, if the stent graft of the present invention is used for aortic intraluminal repair, since the concave covered membrane 210 is separated from the supporting frame 110 and forms a temporary operating space M with the supporting frame 110, which is equivalent to the concave covered membrane 210 dividing the corresponding region of the aortic arch 401 into an upper flow channel and a lower flow channel, the position of the concave covered membrane 210 corresponds to the position of the branch vessel, so that the branch vessel and the aortic arch 401 can be communicated through the temporary operating space M (i.e., the upper flow channel), thereby avoiding ischemia of organs such as brain caused by the long-term closure of the branch vessel by the membrane during the operation; in addition, the temporary operation space M increases the operation space for operating the guide wire and the sheath tube to pass through the opening, and reduces the difficulty of operation of a doctor.

For easy understanding, referring to fig. 1g and 1h, if the supporting frame 110 is classified according to whether a coating is attached or not, the supporting frame can be divided into a first frame part 110a to which the coating is attached and a second frame part 110b to which the coating is not attached, the temporary operating space is specifically formed between the second frame part 110b and the concave coating 210, and since the coating is not attached to the second frame part 110b, a guide wire, a sheath, a parallel bracket, and the like can smoothly pass through the second frame part 110b to enter the temporary operating space M during surgery.

In some embodiments of the present invention, the length of the concave covering membrane 210 in the axial direction ranges from 20mm to 80 mm. For example, 20mm, 30mm, 40mm, 50mm, 60mm, 70mm, 80mm may be used. In the actual implementation process, the covered stent with the concave covered membrane with the corresponding length needs to be selected according to factors such as individual difference of a diseased region and the aortic arch 401 of a patient.

In some embodiments of the present invention, referring to fig. 1e to 1h in combination, the support body 100 further includes a pre-concave frame 120, the pre-concave frame 120 includes a support portion 120a and a pre-concave portion 120b that are arranged along a circumferential direction, the concave coating 210 is attached to the pre-concave portion 120b, a coating that is located at the same axial position as the concave coating 210 is attached to the support portion 120a, and the pre-concave portion 120b can be expanded or expanded and restored along a radial direction of the stent graft, so that a cross section of the stent graft is fixed to be circular, that is, the stent graft is in a pipe-like shape after being expanded.

It is to be understood that, referring to fig. 1a, 1e, 1f, the pre-pit frame 120 and the support frame 110 are not separate frames, instead, when the support body 100 is divided into a first branch section a, a second branch section B and a third branch section C along the axial direction of the stent graft, the support frame 110 is distributed with sub-support frames at all branch sections, the pre-concave frame 120 is only disposed on the second branch section B, and the first branch section a is short, so that the second branch section B is almost disposed at the proximal end of the stent graft, and as shown in fig. 1g and 1h, the first frame portion 110a includes a portion to which the coating film is attached, the second frame portion B includes a portion to which the coating film is attached, and the entire third frame portion C includes the first frame portion 110a, and the first frame portion 110B includes a portion to which the coating film 200 is not attached and the second frame portion B includes a portion to which the coating film 200 is not attached. In practical implementation, if the support frame 110 has an equal diameter at each position, the radius of the support portion 120a may be equal to or similar to the support of the support frame 110; if the diameter of the support frame 110 in the axial direction is gradually increased or decreased, the radius of the support portion 120a may be equal to or similar to the cross-sectional radius of the support frame at the adjacent portion.

The pre-concave part 120b of the pre-concave frame 120 can support and position the concave covering film 210, and compared with the completely free mode of the concave covering film 210, the structure of the support main body enables the operation difficulty of the doctor in the operations of film breaking and hole opening, guide wire introduction, sheath tube introduction and the like on the concave covering film 210 to be smaller. In other embodiments (not shown), the pre-concave frame 120 may be provided with only the pre-concave portion 120b, and the support portion 120a is not provided, so that the pre-concave portion 120b is directly connected to the support frame 110, and can also serve as a support and positioning function for the inner concave coating 210.

In some embodiments of the present invention, referring to fig. 1e and fig. 1f, the support frame 110 includes a plurality of support rings 111 arranged at intervals along an axial direction of the stent graft, and referring to fig. 1a to fig. 1d, the support rings 111 are supported at both ends of the stent graft, and the cover membrane 200 is separated from the support rings 111 at a proximal end inwards along a local region of the stent graft in a circumferential direction to form the concave cover membrane 210.

Referring to fig. 1a-1b and fig. 2a-2b, the support ring 111 on the stent graft corresponding to the end where the concave covered membrane 210 is located is a concave section support ring, a covered membrane is attached to a local part of the concave section support ring, a covered membrane is not attached to a local part, that is, a covered membrane is attached to the support section 1111, and a covered membrane is not attached to the hollow section 1112. For convenience of understanding, the support rings located at the first branch section a and the second branch section B are referred to as a first-type support ring, and the support rings located at the third branch section are referred to as a second-type support ring, according to the classification of the arrangement position of the support ring 111, wherein the first-type support ring is a concave section support ring.

Referring to fig. 1a-1h, fig. 2a-2b, fig. 3, and fig. 4, the pre-recessed frame 120 includes at least one pre-recessed ring 121 disposed along the axial direction of the stent graft, each pre-recessed ring 121 includes an outer arcuate section 1211 and an inner concave section 1212 connected along the circumferential direction of the stent graft, the outer arcuate section 1211 forms the supporting portion 120a, the inner concave section 1212 forms the pre-recessed portion 120b, and the inner concave membrane 210 is attached to the inner concave section 1212.

In some embodiments of the present invention, the sectional area of the pre-concave frame 120 is greater than or equal to half of the sectional area of the support frame 110, that is, the area enclosed by the pre-concave ring 121 is greater than or equal to half of the area enclosed by the support ring 111.

For ease of understanding, the cross-sectional profile of pre-recessed frame 120 or the annular profile of pre-recessed ring 121 may be understood as a "D" profile or a "saddle" profile,

in some embodiments of the present invention, referring to fig. 1a-1b, fig. 2a-2b, fig. 3, fig. 4, the peaks or valleys of the inner concave sections 1212 are denser than the peaks or valleys of the support ring 111, and the height of the inner concave sections 1212 in the axial direction is smaller than the height of the support ring 111 in the axial direction. With the structure, when the pre-concave ring 121 and the support ring 111 are made of the same material and by the same process, the concave section 1212 is easier to deform than the support ring 111, and the concave section 1212 is reliably expanded along the radial direction in the operation process. In the drawings of the embodiments, the peaks or valleys of the segments of the entire pre-concave ring 121 are denser than those of the supporting ring 111, the height of the entire pre-concave ring 121 in the axial direction is smaller than that of the supporting ring 111, and in an actual implementation, the outer arched segment 1211 of the pre-concave ring 121 may also adopt the same wavelength and wave height as those of the supporting ring 111, and only the inner concave segment 1212 changes the wavelength and wave height.

In some embodiments of the present invention, referring to fig. 1a, the number of the pre-recessed rings 121 is one, and the pre-recessed rings 121 are disposed between two of the inner recessed segment support rings nearest to one end of the stent graft and are axially spaced apart from the adjacent inner recessed segment support rings.

In some embodiments of the present invention, the number of peaks or valleys in the support ring 111 is greater than or equal to 3 and the number of peaks or valleys in the pre-reentrant ring 121 is greater than or equal to 6. For example, with reference to fig. 5a-5b, the number of peaks or troughs of the support ring 111 is 6, and with reference to fig. 6a-6b, the number of peaks or troughs of the pre-recessed ring 121 is 12.

In some embodiments of the present invention, referring to fig. 1g-1h, the covering film 200 includes a main body covering film 220 and the concave covering film 210, and the main body covering film 220 is attached to the support frame 110, that is, the main body covering film 220 is attached to the first frame portion 110a and is attached to the support portion 120a of the pre-concave frame 120.

In some embodiments of the present invention, referring to fig. 1g to 1h, the concave coating 210 is attached to the inner surface of the pre-concave part 120b, and the main body coating 220 is attached to the inner surface of the support frame 110, that is, the main body coating 220 is attached to the inner surface of the first frame part 110 a.

In other embodiments of the present invention (not shown), the concave covering film is attached to the inner surface of the pre-recessed portion, and the main covering film is attached to the outer surface of the supporting frame, that is, the main covering film is attached to the outer surface of the first frame portion 110 a.

In some embodiments of the present invention (not shown), the concave coating film is attached to an inner surface of the pre-concave portion, and the main body coating film includes an outer layer coating film attached to an outer surface of the support frame and an inner layer coating film attached to an inner surface of the support frame, that is, the outer layer coating film is attached to an outer surface of the first frame portion 110a, and the inner layer coating film is attached to an inner surface of the first frame portion 110 a.

The recessed cover film 210 and the main body cover film 220 may be formed separately or integrally, but are preferably formed integrally, regardless of whether the main body cover film 220 is attached to the inner surface and/or the outer surface of the first frame portion 110 a.

In some embodiments of the present invention, the diameter of the supporting ring 111 is in the range of 10-40mm, the radius of the supporting portion 120a of the pre-concave frame 120 is in the range of 5-20mm, and the radius of the outer arc 1211 of the pre-concave ring 121 is equal to or similar to the radius of the supporting ring 111. For example, the support ring 111 and the outer arcuate section 1211 may have a radius of 5mm, 8mm, 10mm, 12mm, 15mm, 18mm, 20mm, etc.

In some embodiments of the present invention, the wire diameter of the support ring 111 and pre-recessed ring 121 may range from 0.1mm to 1mm, for example, the wire diameter of the support ring 111 and pre-recessed ring 121 may be 0.1mm, 0.2mm, 0.5mm, 0.6mm, 0.8mm, 1mm, etc.

In some embodiments of the present invention, the height of the support ring 111 along the axial direction ranges from 5mm to 40mm, and the height of the pre-concave ring 121 along the axial direction ranges from 4mm to 20 mm.

In actual implementation, the parameters of the support ring 111 and the pre-concave ring 121 are ultimately determined according to the actual anatomical size of the aorta. As an example, the diameter of the support ring 111 is 30mm, the wave height of the support ring 111 is 13mm, the support ring 111 includes 6 peaks or valleys, the radius of the outer arc 1211 of the pre-concave ring 121 is 15mm, that is, the diameter of the pre-concave ring 121 after being expanded is also 30mm, the wave height of the pre-concave ring 121 is 4mm, and the pre-concave ring 121 includes 12 peaks or valleys.

In some embodiments of the present invention, two adjacent support rings 111 are arranged at equal intervals, and the interval between two adjacent support rings 111 is greater than 0 and less than 20mm, preferably 2-6 mm. For example, it may be 2mm, 3mm, 4mm, 5mm, 6 mm.

In some embodiments of the present invention, the support ring 111 and the pre-recessed ring 121 are made of a memory alloy. Preferably, titanium alloy is used.

In some embodiments of the invention, the support ring 111 is printed from a 3D metallic material; in other embodiments of the present invention, the support ring 111 is made using laser cutting of sheet material.

In some embodiments of the present invention, pre-recessed ring 121 is supported by a 3D metallic material print; in other embodiments of the present invention, the pre-recessed ring 121 is formed by partially deforming a reset ring by supporting the reset ring after reset using a laser cut sheet material.

In other embodiments of the present invention, referring to fig. 4, the number of the pre-recessed rings 121 is at least two, and each pre-recessed ring 121 is disposed between two of the inner recessed segment support rings nearest to one end of the stent graft and is axially spaced apart from the adjacent inner recessed segment support ring.

In each drawing, the support ring 111 is undulated in the axial direction, and the pre-recessed ring 121 is also undulated in the axial direction.

In still other embodiments of the present invention, referring to fig. 3, the number of the pre-recessed rings 121 is at least two, and each of the pre-recessed rings 121 and the inner concave segment supporting rings are alternately arranged along the axial direction of the stent graft.

In fig. 3 and 4, the support ring 111 is also undulating in the axial direction, and the pre-recessed ring 121 is also undulating in the axial direction.

In summary, in the stent graft of the present invention, a temporary operation space M is formed between the concave cover 210 at one end of the stent graft and the supporting frame 110 at the outer side thereof, so as to provide a temporary blood flow channel for membrane rupture and opening of the openings, which is beneficial to avoid ischemia of the brain organs caused by the long-term closure of the branch vessels by the cover in the operation, and increase the operation space for operating the guide wire and the sheath to pass through the openings, thereby reducing the operation difficulty for the doctor to operate.

Correspondingly, the invention also provides a blood channel repairing assembly, which is shown in fig. 8a-8c and comprises a spreader 300 and any one of the covered stents, wherein the spreader 300 is used for spreading the concave covered stent 210 in the covered stent, so that the cross section of the covered stent is fixed to be circular.

In some embodiments, the spreader 300 is a bare stent.

When the stent graft is used for aortic intraluminal repair, after the stent graft is released at the aortic arch 401, the concave membrane 210 is subjected to membrane rupture and hole opening, the concave membrane 210 divides the corresponding region of the aortic arch 401 into an upper flow channel and a lower flow channel, blood flows through the aorta and the upper flow channel and enters the branch blood vessel through the membrane rupture and hole opening for circulation, or the blood flows through the aorta and the lower flow channel and continues to flow along the aorta. After the bare stent is guided and released in the covered stent; and then installing the branch stent from the approach of the branch blood vessel or the aorta blood vessel, guiding the bare stent into the covered stent and releasing the bare stent after the branch stent is installed, and gradually expanding the pre-concave part 120b of the pre-concave frame 120 of the covered stent along the radial direction in the release process of the bare stent, and then expanding the concave covered stent 210 until the cross section of the covered stent is fixed to be circular, as shown in fig. 8a-8 c.

Correspondingly, the invention also provides a blood channel repairing assembly, which is shown in fig. 9a-9c and comprises a covered stent and a pull wire 600, wherein the support ring at which the outermost end of the covered stent is separated from the concave covering membrane 210 is a pull support ring 111a, and one end of the pull wire 600 bypasses the pull support ring 111a from the covered stent and then returns to the covered stent, so that the pull wire 600 is hooked on the part, which is not attached with the covering membrane, of the pull support ring 111 a.

When the required channel repair is needed, the covered stent is guided into and released at the corresponding part of the aortic arch 401, after the branch stent is inserted, the two ends of the pulling wire 600 are pulled, the pulling wire 600 is tightened, the pulling wire 600 is radially inwardly picked to enable the pulling stent ring 600 to be partially and internally buckled in the concave covered membrane 210, the pulling wire 600 is released to enable the pulling support ring 600 to outwards push open the concave section 1212 of the pre-concave ring 121 and the concave covered membrane 210 in the resetting process, and the cross section of the covered stent is completely deformed to be circular.

It should be noted that the pulling support ring 111a here belongs to the inner concave section support ring, i.e. the support ring located at the outermost end. The blood repairing assembly is suitable for being used without a naked stent, and after the pre-concave ring 121 is reset, one end of the pulling line 600 can be pulled out, so that the pulling line 600 can be pulled out.

Accordingly, the present invention also provides a stent graft distraction method, referring to FIGS. 9a-9c, wherein the stent graft is any one of the stent grafts provided with the support ring 111 and the pre-concave ring 121; the pulling support ring 111a is the support ring 111 where the outermost end of the stent graft is separated from the concave tectorial membrane 210, and the spreading method comprises the following steps:

before the stent graft is inserted, a traction wire 600 is arranged, one end of the traction wire 600 is returned to the stent graft after bypassing the traction support ring 111a from the inside of the stent graft, and the traction wire 600 is hooked on the part, which is not attached with a membrane, of the traction support ring 111 a;

after the covered stent is inserted and released, the pulling wire 600 is tightened by tensioning two ends of the pulling wire 600, the pulling wire 600 is inwardly pulled along the radial direction, the pulling stent ring 111a is partially and internally buckled in the concave covered membrane 210, then the pulling wire 600 is released to outwards push open the concave section 1212 of the pre-concave ring 121 and the concave covered membrane 210, and the cross section of the covered stent is completely deformed to be circular;

after the pre-concave ring 121 is reset, one end of the pulling line 600 can be pulled, and the pulling line 600 can be pulled out.

Correspondingly, the invention also provides a blood channel repairing assembly, which is combined with the blood channel repairing assembly shown in fig. 10 and comprises a parallel bracket 700 and any one of the covered stents, wherein the parallel bracket 700 is used for establishing a branch channel which is parallel to the internal channel of the covered stent.

The parallel stent 700 passes through a portion of the support frame 110 to which the stent graft is not attached, so that a part of the branched section of the parallel stent 700 is positioned in the temporary operation space M and a part of the branched section is positioned outside the stent graft.

During operation, the stent graft may be inserted into the aortic arch 401, the stent graft may be released, and then the parallel stent 700 may be introduced from the branch vessel (e.g. innominate artery 402, left common carotid artery 403), such that one end of the parallel stent 700 passes through the portion of the support frame 110 from the outside to the inside where the stent graft 200 has been detached, and enters the temporary operating space M, thereby establishing the branch passage. In this process, the second frame portion 110b of the support frame 110 substantially passes through the parallel bracket 700.

The temporary operation space M provides enough space for the insertion of the parallel stent 700, the operation is more convenient, and the temporary operation space M can always communicate the branch vessel with the aorta, which is beneficial to avoiding cerebral ischemia caused by the closure of the branch vessel.

In fig. 10, the membrane rupture device 800 is used to rupture the membrane of the stent graft, and the parallel stent technique and the membrane rupture technique are used, and in the actual implementation process, the parallel stent technique, the membrane rupture technique or the two techniques can be used according to the requirement.

Thus, although the present invention has been described herein with reference to particular embodiments thereof, a latitude of modification, various changes and substitutions are intended in the foregoing disclosures, and it will be appreciated that in some instances some features of the invention will be employed without a corresponding use of other features without departing from the scope and spirit of the invention as set forth. Thus, many modifications may be made to adapt a particular situation or material to the essential scope and spirit of the present invention. It is intended that the invention not be limited to the particular terms used in following claims and/or to the particular embodiment disclosed as the best mode contemplated for carrying out this invention, but that the invention will include any and all embodiments and equivalents falling within the scope of the appended claims. Accordingly, the scope of the invention is to be determined solely by the appended claims.

Claims (21)

1. Tectorial membrane support, its characterized in that: comprises a support main body and a film, wherein the support main body comprises a support frame,

the tectorial membrane is attached to on the braced frame, the tectorial membrane inwards breaks away from along the regional of tectorial membrane support circumference braced frame forms the indent tectorial membrane, the indent tectorial membrane is located the one end of tectorial membrane support, form interim operating space between the braced frame in indent tectorial membrane and its outside.

2. The stent-graft of claim 1, wherein: the supporting main body further comprises a pre-concave frame, the pre-concave frame comprises a supporting portion and a pre-concave portion, the supporting portion and the pre-concave portion are arranged along the circumferential direction, the inner concave covering film is attached to the pre-concave portion, the covering film which is located at the same axial position with the inner concave covering film is attached to the supporting portion, and the pre-concave portion can be unfolded or unfolded to reset along the radial direction of the covered stent, so that the cross section of the covered stent is fixed to be circular.

3. The stent graft of claim 2, wherein:

the supporting frame comprises a plurality of supporting rings which are arranged along the axial direction of the covered stent at intervals, the supporting rings are supported at two ends of the covered stent, and the covered membrane is inwards separated from the supporting ring at one end along the local area of the circumference of the covered stent to form the inwards concave covered membrane;

the pre-concave frame comprises at least one pre-concave ring arranged along the axial direction of the covered stent, each pre-concave ring comprises an outer arch section and an inner concave section which are connected along the circumferential direction of the covered stent, the outer arch section forms the supporting part, and the inner concave section forms the pre-concave part.

4. The stent graft of claim 3, wherein the support ring at the end of the stent graft corresponding to the inwardly concave stent graft is an inwardly concave section support ring,

the local part of the concave section support ring is attached with a coating, and the local part is not attached with the coating.

5. The stent-graft of claim 4, wherein: the pre-concave ring is arranged between two concave section support rings closest to one end of the covered stent and is axially spaced from the adjacent concave section support rings.

6. The stent-graft of claim 4, wherein: the number of the pre-concave rings is at least two, and each pre-concave ring is arranged between two concave section support rings closest to one end of the covered stent and is axially spaced from the adjacent concave section support rings.

7. The stent-graft of claim 4, wherein: the number of the pre-concave rings is at least two, and the pre-concave rings and the inner concave section supporting rings are alternately arranged at intervals along the axial direction of the film coating support.

8. The stent graft of claim 3, wherein: the support ring is wavy along the axial fluctuation, and the pre-concave ring is wavy along the axial fluctuation.

9. The stent graft of claim 8, wherein: the wave crests or wave troughs of the concave sections are denser than those of the support ring, and the height of the concave sections in the axial direction is smaller than that of the support ring in the axial direction.

10. The stent graft of any one of claims 2-9, wherein: the covering film comprises a main body covering film and the inwards concave covering film, and the main body covering film is attached to the supporting frame and is attached to the supporting portion of the pre-concave frame.

11. The stent graft of claim 10, wherein: the concave covering film is attached to the inner surface of the pre-concave part, and the main body covering film is attached to the inner surface or the outer surface of the supporting frame.

12. The stent graft of claim 10, wherein: the concave covering film is attached to the inner surface of the pre-concave part, and the main body covering film comprises an outer layer covering film attached to the outer surface of the supporting frame and an inner layer covering film attached to the inner surface of the supporting frame.

13. The stent graft of claim 3, wherein: the sectional area of the pre-concave frame is greater than or equal to half of the sectional area of the support frame.

14. The stent graft of claim 3, wherein: the distance between two adjacent support rings is more than 0 and less than 20 mm.

15. The stent-graft of claim 14, wherein: the distance between two adjacent support rings is 2-6 mm.

16. The stent-graft of claim 1, wherein: the length range of the concave covering film along the axial direction is between 20mm and 80 mm.

17. A blood pathway repair assembly comprising:

a stent graft according to any one of claims 1 to 16;

and the opening piece is used for opening the concave covered membrane in the covered stent, so that the cross section of the covered stent is fixed to be circular.

18. The blood channel repair assembly of claim 17, wherein: the spreader is a bare stent.

19. A blood pathway repair assembly comprising:

a stent graft according to any one of claims 3 to 16;

the supporting ring at the outermost end of the covered stent, which is separated from the concave covered membrane, is a traction supporting ring, and one end of the traction wire bypasses the traction supporting ring from the covered stent and then returns to the covered stent, so that the traction wire is hooked on the part, which is not attached with the covered membrane, of the traction supporting ring;

tightening the pulling wire by pulling both ends of the pulling wire;

and (3) inward radial stretching of the traction line leads the local part of the traction stent ring to be internally buckled in the concave tectorial membrane, and then the traction line is released to outwards jack the concave section of the pre-concave ring and the concave tectorial membrane, so that the cross section of the tectorial membrane stent is completely deformed to be circular.

20. The method for opening the covered stent is characterized by comprising the following steps: the stent graft is the stent graft of claims 3-16, the support ring at the outermost end of the stent graft, which is separated from the concave tectorial membrane, is a pulling support ring; the distraction method comprises the following steps:

before the stent graft is inserted, a traction wire is configured, one end of the traction wire is wound around the traction support ring from the inside of the stent graft and then returns to the inside of the stent graft, so that the traction wire is hooked on the part, which is not attached with a coating, on the traction support ring;

after the covered stent is inserted and released, the pulling wire is tightened by tensioning the two ends of the pulling wire, the pulling wire is inwards pulled along the radial direction to enable the local part of the pulling stent ring to be internally buckled in the concave covered film, then the pulling wire is released, the concave section of the pre-concave ring and the concave covered film are outwards pushed open, and the cross section of the covered stent is completely deformed to be circular.

21. A blood pathway repair assembly comprising:

a stent graft according to any one of claims 1 to 16;

a parallel stent for establishing a branch channel juxtaposed to the stent graft internal channel,

the parallel stent passes through the part, which is not attached with the tectorial membrane, of the support frame, so that part of the branch sections of the parallel stent are positioned in the temporary operation space, and part of the branch sections are positioned outside the tectorial membrane stent.

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