Covered stent and stent system

Abstract

The application provides a covered stent and a stent system. The covered stent comprises a main stent and a wrapping piece. The main stent comprises a main wave coil and a main covering film. The main covering film is covered on the main wave coil. The wrapping piece is connected to one side of the main stent. The wrapping piece can releasably wrap the main stent to make the main stent radially compressed or released. The width of the wrapping piece at a certain position is defined as W. The circumference of the covered stent at the position corresponding to the width W of the wrapping piece in the natural expansion state is defined as C. The relationship between W and C satisfies W≤C / 4. The relationship between W and C satisfies W≤C / 4, which can guarantee the semi-constrained degree of the covered stent, facilitate the repeated adjustment of the covered stent in the axial direction when the covered stent is implanted into a blood vessel, and guarantee that the wrapping piece provides a channel for selecting a branch blood vessel when the covered stent is radially compressed, so that the movable space of the channel in the radial direction is not too large.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to a covered stent and stent system. Background Technology

[0002] In the past decade or so, endovascular aortic stent graft repair has been widely used for lesions such as aneurysms and aortic dissections in the thoracic and abdominal aortas. It has proven to be effective, minimally invasive, quick to recover, and has few complications, making it a first-line treatment method.

[0003] For aortic aneurysms or dissections involving branches such as the aortic arch, celiac trunk, bilateral renal arteries, or superior mesenteric artery, the use of covered stents can affect the blood supply to the branch vessels. In such cases, appropriate perforations are created in the covered stent to allow blood flow to the branch vessels. Typically, the diameter of the perforation is close to that of the branch vessel. Ensuring that the perforation precisely coincides with the branch vessel and that the guidewire is inserted into the branch vessel are crucial for branch reconstruction. For the former, a common method is to use sutures to circumferentially constrain the stent, causing radial compression. After release from the delivery sheath, the stent remains in a radially compressed state, facilitating intraoperative positioning and allowing for precise stent adjustment. Alternatively, for aortic aneurysms or dissections that do not involve branches but require precise stent placement, the aforementioned semi-constraint method can be used for further precise positioning before complete stent release. However, the sutures currently used cannot completely wrap around the axial direction of the stent, which may cause the following problems: the stent may be partially covered by the sutures, and the metal wires on the stent have a strong self-expansion force, causing the stent to lift up locally, making the outer surface of the stent rough. When the doctor adjusts the position of the stent, the lifted part will rub against the blood vessel wall, causing the attached thrombus on the blood vessel wall to detach and flow into the branch blood vessels. Summary of the Invention

[0004] At least one technical problem solved by the present invention is how to ensure the uniformity of the semi-binding of the covered stent in the axial direction, so as to facilitate repeated adjustment of the stent position in the axial direction, while ensuring that the covered stent provides a channel for easy selection of branch vessels when it is radially compressed by the wrapping element.

[0005] This invention provides a coated support structure, comprising a main support and a wrapping component. The main support includes a main corrugated coil and a main coating, the main coating covering the main corrugated coil. The wrapping component is connected to one side of the main support and can releasably wrap the main support to allow the main support to be radially compressed or released. The width of the wrapping component at a certain position is defined as W, and the perimeter of the coated support in its naturally expanded state at a position corresponding to the width W of the wrapping component is defined as C. The relationship between W and C satisfies: W ≤ C / 4.

[0006] In one embodiment, the package is connected to the main support via a binding wire. The main support includes a binding attachment, which includes a portion of the main corrugated coil or a binding wire. The binding attachment extends along the main film. The main film includes a first perforation and a second perforation, which are respectively located on both sides of the extension direction of the binding attachment. The binding wire passes through the first perforation and the second perforation and crosses the binding attachment.

[0007] In one embodiment, the binding wire is connected to the wave rod, wave crest, or wave trough of the main wave ring;

[0008] Alternatively, one of the main wavering loops is connected by a steel sleeve in a wave-shaped ring, and the binding wire is connected to the main wavering loop, with the binding wire close to the edge of the steel sleeve.

[0009] In one embodiment, the body covering includes a linear film wound around the circumference of the body covering;

[0010] The binding wire is connected to the wave rod of the main wave coil, and at least one linear membrane is provided on the proximal end and the distal end of the binding wire;

[0011] Alternatively, the binding wire is connected to the crest of the main wave bar, and at least one linear membrane is provided on the distal end of the binding wire;

[0012] Alternatively, the binding wire is connected to the trough of the main wave rod, and at least one linear membrane is provided on the distal end of the binding wire.

[0013] In one embodiment, the main body covering includes a linear film that is wound circumferentially around the main body covering; the shortest distance L1 of the linear film in the axial direction to the edge of the first perforation satisfies: L1≤3mm, and / or the shortest distance L2 of the linear film in the axial direction to the edge of the second perforation satisfies: L2≤3mm.

[0014] In one embodiment, the package includes a cushioning element, a third perforation, and a fourth perforation. The cushioning element extends along the plane of the package. The third perforation and the fourth perforation are respectively located on both sides of the extending direction of the cushioning element. The binding thread passes through the first perforation and the second perforation and crosses the binding attachment, then passes through the third perforation and the fourth perforation and crosses the cushioning element before being knotted.

[0015] In one embodiment, the covered stent further includes a branch stent, and the lumen of the branch stent is in communication with the lumen of the main stent. The main stent includes a first side and a second side in the circumferential direction. The package is connected to the first side of the main stent by a binding wire, and the branch stent is connected to the second side of the main stent. The main stent includes a proximal end segment, and at least one binding attachment is provided on the first side of the proximal end segment.

[0016] In one embodiment, the proximal segment includes a first main wave loop and a second main wave loop sequentially from the proximal end to the distal end, and the binding wire includes a first binding wire and a second binding wire;

[0017] The first binding wire is disposed on the wave rod, wave crest or wave trough on the first side of the first main wave ring, and the second binding wire is disposed on the wave rod, wave crest or wave trough on the first side of the second main wave ring.

[0018] Alternatively, the main support includes a curved section, which is closer to the distal end than the proximal end. The curved section includes a third main wavering and a fourth main wavering sequentially from the proximal end to the distal end. The first binding wire is disposed on the wave rod, wave crest, or wave trough on the first side of the first or second main wavering, and the second binding wire is disposed on the wave rod, wave crest, or wave trough on the first side of the third or fourth main wavering.

[0019] The present invention also provides a stent system, the stent system including the covered stent as described above, the stent system further including a conveyor, the conveyor including a sheath core assembly, a support rod, a sheath tube, and a detachable bundle diameter member, the sheath core assembly including an inner sheath core and an outer sheath core, the inner sheath core, the outer sheath core, the support rod and the sheath tube being sequentially sleeved from the inside to the outside, the support rod being sleeved outside the sheath core assembly; the conveyor further includes a guide head, the guide head being disposed at the distal end of the inner sheath core, the distal end of the support rod being spaced apart from the proximal end of the guide head to form a loading space for the covered stent; the detachable bundle diameter member cooperates with the wrapping member to achieve radial contraction and release of the covered stent.

[0020] In one embodiment, the stent system further includes a pre-positioned catheter extending within the lumen of the main stent, the distal end of the pre-positioned catheter extending out from the branch stent.

[0021] In one embodiment, the pre-installed conduit includes a straight section and a pre-bent section, the pre-bent section being disposed at the distal end of the straight section.

[0022] In one embodiment, at least a portion of the pre-bent section of the pre-placed catheter extends beyond the proximal side of the main support, the proximal side of the main support including a gap, wherein in the delivery state, at least a portion of the pre-bent section is embedded in the gap to maintain the pre-bent shape of the pre-bent section.

[0023] One technical effect of an embodiment of the present invention is that setting the relationship between W and C to satisfy W≤C / 4 can ensure the degree of semi-binding of the covered stent, which facilitates repeated axial adjustments when the stent is implanted into the blood vessel. At the same time, it ensures that when the covered stent is radially compressed by the wrapping component, it provides a channel for easy selection of branch vessels, so that the radial movement space of the channel is not too large. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the structure of the film-coated support provided in one embodiment of the present invention;

[0025] Figure 2 This is a partial structural schematic diagram of a film-coated support provided according to an embodiment of the present invention (partial film coating omitted);

[0026] Figure 3 This is a partial structural diagram of the cooperation between the film-coated support (partial film covering omitted) and the binding wire provided in one embodiment of the present invention;

[0027] Figure 4 This is a planar unfolded view of the membrane provided in one embodiment of the present invention;

[0028] Figure 5 This is a schematic diagram of the structure of a film-coated support provided in another embodiment of the present invention;

[0029] Figure 6 This is a schematic diagram of the structure connecting the membrane and the main support according to an embodiment of the present invention (the main body membrane is omitted);

[0030] Figure 7 This is a schematic diagram of the structure of a portion of the main support provided in one embodiment of the present invention;

[0031] Figure 7a A schematic diagram of the structure of a portion of the main support provided in another embodiment of the present invention;

[0032] Figure 7b A schematic diagram of the structure of a portion of the main support provided in another embodiment of the present invention;

[0033] Figure 8 for Figure 7 Enlarged view of point B in the middle;

[0034] Figure 9 This is a schematic diagram of the structure of the film-coated support provided in another embodiment of the present invention;

[0035] Figure 10 for Figure 9 A diagram showing the bending state of a curved blood vessel;

[0036] Figure 11 This is a schematic diagram of the structure of the film-coated support provided in another embodiment of the present invention;

[0037] Figure 12 for Figure 11 A diagram showing the bending state of a curved blood vessel;

[0038] Figure 13 for Figure 11 The right view;

[0039] Figure 14 for Figure 11 A schematic diagram of the structure of the covered stent (showing the branch stent portion within the main stent).

[0040] Figure 14a Figure 14 Enlarged view of point C in the middle;

[0041] Figure 15 This is a schematic diagram of the support system provided in one embodiment of the present invention;

[0042] Figure 16 A schematic diagram of the support rod provided in one embodiment of the present invention from an axial perspective.

[0043] Figure 16a A schematic diagram of the support rod provided in another embodiment of the present invention from an axial perspective;

[0044] Figure 17 A schematic diagram of the structure of a stent system provided in an embodiment of the present invention, wherein the covered stent is radially compressed by being wrapped in a film (the detachable bundle diameter component includes a bundle diameter guide wire);

[0045] Figure 18 A schematic diagram of the structure of a covered stent system provided in another embodiment of the present invention, wherein the stent is wrapped in a film and radially compressed (the releasable bundle diameter component includes a releasable suture structure);

[0046] Figure 19 for Figure 18 Schematic diagram of the structure with partial release of constraints in the middle constraint section;

[0047] Figure 20 This is a partial structural diagram of the guide head and inner sheath core provided in one embodiment of the present invention;

[0048] Figure 21 This is a schematic diagram of the card component in the rear release structure provided by one embodiment of the present invention;

[0049] Figure 22 A diagram showing the closable state formed by the locking mechanism and slot of the rear-release structure provided in one embodiment of the present invention;

[0050] Figure 23 The guiding catheter access established through branch vessels when the stent system provided in one embodiment of the present invention is implanted at the aortic arch;

[0051] Figure 24 This is a schematic diagram of a stent system provided in one embodiment of the present invention being inserted into the aortic arch along an ultra-rigid guidewire.

[0052] Figure 25 This is a schematic diagram showing the initial positioning of the stent system at the aortic arch after sheath withdrawal, according to an embodiment of the present invention.

[0053] Figure 26 This is a schematic diagram showing the alignment of the branch port of the covered stent of the stent system provided in one embodiment of the present invention with the branch vessel.

[0054] Figures 27 to 28 The support system provided in one embodiment of the present invention is shown in the figure, in which the guide wire or suture structure of the bundle diameter is pulled backward so that the main support unfolds and adheres to the wall from the proximal end to the distal end.

[0055] Figure 29 For relative Figure 28 A schematic diagram showing the retraction of the branch sheath to allow the branch stent to deploy and adhere to the branch vessel;

[0056] Figure 30 A schematic diagram of the support system provided in another embodiment of the present invention;

[0057] Figure 31 for Figure 30 Schematic diagram of the covered stent structure of the stent system;

[0058] Figure 32 for Figure 31 Enlarged view of point D in the middle;

[0059] Figure 33 A schematic diagram of the pre-placed catheter in a stent system provided in another embodiment of the present invention;

[0060] Figure 34 A schematic diagram of the ultra-rigid guidewire being inserted into the aortic arch before implantation of the stent system provided in another embodiment of the present invention;

[0061] Figure 35 This is a schematic diagram of the stent system provided in another embodiment of the present invention being introduced into the aortic arch along an ultra-rigid guidewire;

[0062] Figure 36 For relative Figure 35 A schematic diagram showing the sheath being retracted so that the covered stent, which is wrapped in membrane, is exposed outside the sheath in a membrane-enclosed state.

[0063] Figure 37 For relative Figure 36 A schematic diagram showing how rotating the pre-bent section of the pre-placed conduit disengages it from the gap of the first bare wave ring.

[0064] Figure 38 For relative Figure 37 A diagram illustrating the direct insertion of a pre-placed catheter into a branch vessel.

[0065] Figure 39 For relative Figure 38 A schematic diagram showing the forward-propelled stent system aligned with the annular support member and the left subclavian artery;

[0066] Figure 40 For relative Figure 39 A schematic diagram showing how retracting the guidewire allows the membrane to open, and the covered support naturally expands to essentially adhere to the wall.

[0067] Figure 41 For relative Figure 40 A schematic diagram showing the release of the first bare wave coil using the post-release structure, and the retraction of the pre-placed catheter and delivery device;

[0068] Figure 42 For relative Figure 41 A schematic diagram showing the implantation of an external extension stent along the branch guidewire and the withdrawal of the branch guidewire;

[0069] Figure 43 This is a schematic diagram of the structure of the film-coated support provided in another embodiment of the present invention;

[0070] Figure 44 for Figure 43 The right view;

[0071] Figure 45 for Figure 43 The covered stent is guided into the aortic arch by the stent system along the ultra-hard guidewire, the sheath is then withdrawn to expose the capsule outside the sheath, and the pre-placed catheter is selected into the left common carotid artery.

[0072] Figure 46 For relative Figure 45 A schematic diagram showing the forward-propelled stent system aligned with the annular support member facing the left common carotid artery;

[0073] Figure 47 For relative Figure 46 A schematic diagram showing how retracting the guidewire allows the membrane to open, and the covered support naturally expands to essentially adhere to the wall.

[0074] Figure 48For relative Figure 47 A schematic diagram showing the release of the first bare wave coil using the post-release structure, and the retraction of the pre-placed catheter and delivery device;

[0075] Figure 49 For relative Figure 48 A schematic diagram showing the implantation of an external extension stent along the branch guidewire to the left common carotid artery and the withdrawal of the branch guidewire.

[0076] Figure 50 For relative Figure 49 A small external stent was implanted into the left subclavian artery to match the embedded stent. Detailed Implementation

[0077] To facilitate understanding of the present invention, a more complete description will be given below with reference to the accompanying drawings. Preferred embodiments of the invention are shown in the drawings. However, the invention can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a thorough and complete understanding of the disclosure of the invention.

[0078] It should be noted that when an element is referred to as being "fixed to" another element, it can be directly attached to the other element or there may be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "inner," "outer," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0079] "Axial direction" generally refers to the length of a medical device during delivery, while "radial direction" generally refers to the direction perpendicular to the medical device's "axial direction." Based on this principle, the "axial" and "radial" directions of any component of a medical device are defined. Furthermore, when describing luminal stents or covered stents, the orientation can be defined according to the direction of blood flow in the blood vessel. In this invention, blood flow is defined as flowing from the proximal end to the distal end of the stent. In the field of interventional medical devices, for delivery devices used to implant medical devices into humans or animals, the end closer to the operator is generally defined as the "proximal end," and the end farther from the operator is defined as the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of the delivery device are defined.

[0080] The "wave loop" in this invention is a closed annular structure, also known as a wave-shaped ring, made of woven or cut metallic elastic material. A single main wave loop can be connected to both ends of the wave-shaped metallic elastic material by a steel sleeve, thus making the main wave loop annular. This metallic elastic material includes known materials used in implanted medical devices or combinations of various biocompatible materials, such as alloys of two or more single metals from cobalt, chromium, nickel, titanium, magnesium, and iron, as well as 316L stainless steel, nickel-titanium-tantalum alloys, or other biocompatible metallic elastic materials. The wave loop has radial expansion capability, allowing it to radially contract under external force and recover its initial shape after the external force is removed, maintaining this initial shape. Therefore, after implantation into a lumen, its radial support force allows it to adhere tightly to the inner wall of the lumen. The waveform of the wave loop is unrestricted, including Z-shaped waves, M-shaped waves, V-shaped waves, sine waves, etc. The wave loop includes multiple peaks (also known as proximal apexes), multiple troughs (also known as distal apexes), and wave rods connecting adjacent peaks and troughs. In this process, a single wave is formed by a vertex (near or far vertex) and two wave rods connected to that vertex.

[0081] This invention provides a film-coated scaffold 100, such as Figure 1 As shown, the film-coated support 100 includes a main support 10, a first bare wave ring 20, and a wrapping element 30. The main support 10 includes a main wave ring 11 and a main film 12, with the main film 12 covering the main wave ring 11. The main wave ring 11 is a ring structure formed by connecting multiple waveform units end to end. Here, a waveform unit refers to a single-wave structure composed of wave crests, wave rods, and wave troughs, and the shape of the waveform unit is not limited. Each main wave ring 11 can be a regular ring structure formed by multiple waveform units of equal height, or it can be an irregular ring structure including high and low waves formed by waveform units of different wave heights. Adjacent main wave rings 11 can all be regular ring structures, or they can all be irregular ring structures including high and low waves, or they can be a combination of two types of ring structures: regular ring structures and irregular ring structures including high and low waves. This is not limited here.

[0082] The main body covering 12 is a tubular structure with openings at both ends. Multiple main body wave coils 11 are arranged axially and connected through the tubular main body covering 12 to form a tubular main body support 10. The distal end of the first bare wave coil 20 is connected to the proximal end of the main body support 10, and the first bare wave coil 20 is at least partially exposed outside the main body covering 12.

[0083] The package 30 is connected to one side of the main support 10 or is disposed around the main support. The package can releasably wrap the main support 10 so that the main support 10 is radially compressed or unrestrained, thereby constraining the compressed main support 10 within the package or allowing the main support 10 to expand naturally after being unwrapped. In one embodiment, the package 30 can be configured as a film 30a. In some embodiments described below, the package is described using a film as an example.

[0084] like Figure 2-3 As shown, the main coating 12 includes a first film layer 121 and a linear film 122. The linear film 122 is wound around the circumference of the main coating 12. The linear film 122 can be multiple lines wound around the coating support 100 in a direction parallel to the radial direction, or it can be one or more lines wound spirally around the coating support 100 in a direction. The first film layer 121 is attached to one side of the main waveguide 11. The linear film 122 can be disposed between the first film layer 121 and the main waveguide 11, or it can be disposed on the side of the first film layer 121 away from the main waveguide 11, or it can be disposed on the side of the main waveguide 11 away from the first film layer 121. No limitation is made here. In one embodiment, the linear film 122 is disposed on the side of the main waveguide 11 away from the first film layer 121, and it can cooperate with the first film layer 121 to constrain the main waveguide 11.

[0085] In one embodiment, the main body coating 12 further includes a second film layer 123, which is attached to the side of the main body waveguide 11 away from the first film layer 121. The first film layer 121 is attached to the inner side of the main body waveguide 11, and the second film layer 123 is attached to the outer side of the main body waveguide 11. A linear film 122 is disposed between the main body waveguide 11 and the second film layer 123, and the linear film 122 is spirally wound upward along the circumferential direction of the coating support 100. The linear film 122 and the first film layer 121, the first film layer 121 and the second film layer 123, and the linear film 122 and the second film layer 123 can all be fixed together by adhesive bonding or hot pressing.

[0086] The linear membrane 122 can be a linear structure formed by a single strand or multiple strands of wire, with an average wire diameter ranging from 0.05 mm to 0.3 mm. The cross-sectional area of ​​the linear structure can be circular, elliptical, rectangular, etc., and the thickness of the linear structure can be uniform or non-uniform in its extension direction, without limitation. When the cross-sectional area of ​​the linear structure is non-circular, the thickness of the linear structure in the radial direction of the membrane support 100 ranges from 0.05 mm to 0.3 mm. The linear membrane 122 can be made of biocompatible polymer materials such as PTFE wire. In one embodiment, the linear membrane 122 is spirally wound around the membrane support 100 in the circumferential direction, with the spiral angle ranging from 0° to 45°. For example, when the linear membrane 122 is spirally wound around the membrane support 100 in the circumferential direction, the spiral angle can be 0°, 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, etc. The linear membrane 122 can be a single strand spirally ascending at equal intervals or a non-equal interval spiral ascending; the linear membrane 122 can also be multiple strands spirally spaced at equal intervals or non-equal intervals, without limitation, as long as the linear membrane 122 passes around each wave loop.

[0087] like Figure 1 As shown, the main support 10 includes a first side 10a and a second side 10b along the circumferential direction, defining the first side 10a and the second side 10b as arcs each occupying 180° in the circumferential direction.

[0088] Combination Figure 4As shown, the membrane 30a is connected to the first side 10a of the main support 10. The membrane 30a and the main support 10 are connected by a binding wire 40. In one embodiment, the portion of the membrane 30a near the proximal end is connected to the main support 10 near the proximal end by the binding wire. In this embodiment, the axial length of the membrane 30a is equal to the axial length of the main cover 12. In other embodiments, the axial length of the membrane 30a may also be approximately equal to the axial length of the main cover 12. Here, "approximately equal to" means that the axial length of the membrane 30a is approximately equal to the axial length of the main cover 12. The axial length difference ratio is less than or equal to 10%, ensuring that the proximal end of the membrane 30a extends at least to the center of the main body wavelet 11 closest to the heart, and the distal end of the membrane 30a extends at least to the axial center of the main body wavelet 11 furthest from the heart, with neither end of the membrane 30a exceeding the ends of the main body support 10. The larger of the axial lengths of the membrane 30a and the main body covering 12 is defined as H1, and the smaller of the axial lengths of the membrane 30a and the main body covering 12 is defined as H2. The axial length difference ratio is then (H1-H2) / H2. In one embodiment, the membrane is rectangular, the main body covering is tubular, and the axial length of the membrane is slightly larger than the axial length of the main body covering. Therefore, the axial length of the membrane is H1, and the axial length of the main body covering is H2. Figure 4-5 As shown. Define the width of the membrane 30a at a certain position (the direction of this width is perpendicular to the axial direction of the covered support 100) as W, and define the perimeter of the covered support 100 in its natural expansion state at the position corresponding to the width of the membrane 30a as C. Then the relationship between W and C is: W≤C / 4, so that when the membrane 30a wraps and constrains the radially compressed covered support 100, the radial space in which the pre-placed conduit 79 can move is not too large when it is axially moving within the compressed covered support 100.

[0089] The membrane 30a has an elongated strip structure. In one embodiment, the membrane 30a has a rectangular sheet structure, with its length direction corresponding to the axial direction of the main support 10. At least one limiting hole 31 is provided near the edge of each of the two long sides of the membrane 30a. When multiple main wave coils 11 are provided along the axial direction, multiple limiting holes 31 are provided at intervals along the axial direction near the edge of each of the two long sides of the membrane 30a, so that the guide wire 741 can pass through the limiting holes 31 on the two long sides of the membrane 30a in sequence, so that the membrane 30a can form a tubular body, thereby wrapping the radially compressed covered support 100. In this embodiment, a limiting member 35 is provided between the limiting hole 31 and the edge of the membrane 30a to prevent the membrane hole from expanding to the edge of the membrane 30a and breaking the closed state of the membrane hole, thereby avoiding the reliability of the guide wire 741 passing through the membrane hole and enclosing the membrane 30a into a tubular body.

[0090] like Figure 1 , Figure 5 , Figure 9 and Figure 11 As shown, the film 30a is connected to the first side 10a of the main body support 10 by a binding wire 40. When the film support 100 is loaded or released, the film 30a may be subjected to frictional force, causing relative movement between it and the main body film 12. This causes the film 30a and the main body film 12 to be pulled and stressed by the binding wire 40, which may lead to the enlargement of the membrane pores on the main body film 12 through which the binding wire 40 passes and the membrane pores on the film 30a.

[0091] The membrane 30a also includes a buffer 32, which is disposed in the middle region of the membrane 30a and extends along the plane of the membrane 30a. In one embodiment, the buffer 32 may be a reinforcing line extending axially, with the binding thread 40 passing through the membrane pores of the membrane 30a and crossing the buffer 32; in other embodiments, the buffer 32 may also be a reinforcing line extending laterally or obliquely. The buffer 32 may be formed in the plane of the membrane 30a or on the surface of the membrane 30a by heat treatment together with the membrane 30a; the membrane 30a may be a PTFE membrane or a PET membrane, and the reinforcing line may be made of biocompatible polymer threads such as PTFE threads. PTFE threads or membranes have good thermal properties, are chemically inert, self-lubricating, and non-stick, are not easily wetted by tissue fluid, are corrosion-resistant, have the best aging life among plastics, are non-toxic, can withstand pressure, can be implanted in the human body, and can withstand certain tension and tensile forces. PET membranes also have good physicochemical properties and can be used as membrane materials.

[0092] The main support 10 includes a binding attachment 111, which extends along the main film 12. The main film 12 includes a first perforation 124 and a second perforation 125, which pass through the inner and outer sides of the main film 12 respectively. The first perforation 124 and the second perforation 125 are respectively located on both sides of the extension direction of the binding attachment 111. The binding attachment 111 can be configured as a wave rod of a main wave coil 11, that is, the binding attachment 111 includes a part of a main wave coil. The binding attachment 111 can also be a binding wire set on the main film 12. The binding wire can be fixed to the main film 12 by gluing or hot pressing. In one embodiment, the binding attachment 111 is disposed at the proximal end of the main support 10. The main support 10 includes a main wave ring 11 disposed at the proximal end. The binding wire 40 is connected to the wave rod, wave crest, or wave trough of the main wave ring 11. That is, the binding attachment 111 is set as the wave rod, wave crest, or wave trough of the main wave ring 11. The main wave ring 11 is formed by a metal wire rod extending in a wave-like manner along the circumference of the main support 10 to form a wave-shaped ring with the ends connected. The first through hole 124 and the second through hole 125 are respectively disposed on both sides of the extension direction of the binding attachment 111.

[0093] The membrane 30a includes a third perforation 33 and a fourth perforation 34, which are respectively disposed on both sides of the buffer 32 extending in the direction of extension. In one embodiment, the binding thread 40 can pass through the first perforation 124 and the second perforation 125 and cross the binding attachment 111, then pass through the third perforation 33 and the fourth perforation 34 and cross the buffer 32 before being knotted. For the main film covering, when the binding wire 40 passes through the main film covering 12, it crosses the binding attachment 111. When the film covering bracket 100 is loaded or released, although the film covering 30a and the main film covering 12 are pulled by the binding wire 40, the binding wire 40 mainly pulls on the binding attachment 111. When the binding wire 40 is under force, it can reduce the possibility of the membrane holes of the first perforation 124 and the second perforation 125 expanding, thereby preventing internal leakage. The setting of the buffer 32 can make the binding wire 40 mainly pull on the buffer 32 when it is under force. When the binding wire 40 is under force, it can reduce the possibility of the membrane holes (at the third perforation 33 and the fourth perforation 34) on the film covering 30a expanding.

[0094] In other embodiments, the binding thread 40 passes through the first perforation 124 and the second perforation 125 and crosses the binding attachment 111 before being knotted, then passes through the third perforation 33 and the fourth perforation 34 and crosses the buffer 32 before being knotted again; for the main body film, on the one hand, when the binding thread 40 passes through the main body film 12, it crosses the binding attachment 111. When the film support 100 is loaded or released, although the film 30a and the main body film 12 are pulled by the binding thread 40, the binding thread 40 mainly pulls on the binding attachment 111. When the binding thread 40 is under stress, it can reduce the possibility of the membrane pores of the first perforation 124 and the second perforation 125 enlarging, thereby preventing internal leakage. On the other hand, the binding thread 40 passes through the first perforation 124 and the second perforation 125 and crosses the binding attachment 111 before being knotted to form a break in force transmission. This can reduce the pulling force on the main film when the film is pulled by the binding thread, and it also has a certain limiting effect on the binding thread that crosses the main film, thereby further reducing the possibility of the membrane pores of the first perforation 124 and the second perforation 125 enlarging. Furthermore, the setting of the buffer 32 allows the binding thread 40 to be mainly pulled on the buffer 32 when it is under stress. When the binding thread 40 is under stress, it can reduce the possibility of the membrane pores (at the third perforation 33 and the fourth perforation 34) on the film 30a enlarging.

[0095] One or more fixed connection points can be provided between the membrane 30a and the main support 10. These fixed connection points are connected to the corresponding binding attachments 111. In one embodiment, one fixed connection point is provided between the membrane 30a and the main support 10. The binding thread 40 includes a first binding thread 41. The first binding thread 41 passes through the first perforation 124 and the second perforation 125 on the main membrane 12 and crosses over a binding attachment 111. The two ends of the first binding thread 41 are located outside the main support 10. At this time, one or two knots can be tied on the outside of the main support 10, and these knots are ultimately formed between the membrane 30a and the main support 10. Subsequently, the first binding thread 41 passes through the third perforation 33 and the fourth perforation 34 of the membrane 30a and is knotted on the side of the membrane 30a away from the main support 10 to prevent the binding thread 40 from loosening. Simultaneously, the knot of the binding thread 40 is formed outside the lumen of the membrane support 100, avoiding any impact on the blood flow within the lumen. In other embodiments, such as... Figure 5 As shown, two fixed connection points can also be provided between the film 30a and the main support 10. The binding wire 40 also includes a second binding wire 42. The second binding wire 42 can be fixedly connected to the perforations at the corresponding positions on the film 30a and the film support 100 in the same way as the first binding wire 41. This will not be described in detail here.

[0096] In one embodiment, combined Figure 6-8 As shown, the first binding wire 41 is connected to the wave rod of the main wave coil 11. At least one linear membrane 122 is provided on both the proximal and distal ends of the first binding wire 41 to limit the expansion of the first perforation 124 and the second perforation 125 towards the proximal and distal ends, respectively. The shortest distance L1 of the linear membrane 122 in the axial direction to the edge of the first perforation 124 satisfies: L1≤3mm, and the shortest distance L2 of the linear membrane 122 in the axial direction to the edge of the second perforation 125 satisfies: L2≤3mm. In other embodiments, the first binding wire 41 can be connected to the crest of the main wave coil 11, and at least one linear membrane 122 is provided on the distal end of the first binding wire 41 to limit the expansion of the perforation through the main covering film 12 on the inner side of the crest bend; the first binding wire 41 can also be connected to the trough of the main wave coil 11, and at least one linear membrane 122 is provided on the proximal end of the first binding wire 41 to limit the expansion of the perforation through the main covering film 12 on the inner side of the trough bend. In other embodiments, the binding wire may also be attached to the main body wavering and positioned near the edge of the steel sleeve, thereby using the steel sleeve to limit the movement of the binding wire relative to the main body coating.

[0097] like Figure 7-8As shown, the main wave loop 11 is formed by connecting multiple single waves sequentially. The main support 10 includes a main wave loop 11 disposed at the proximal end of the covered support 100. The main wave loop 11 includes a first wave crest 1111, a first wave trough 1112, and a first wave rod 1113 connecting the first wave crest 1111 and the first wave trough 1112. The first wave rod 1113 is used as a binding attachment 111. The first perforation 124 and the second perforation 125 are respectively disposed on both sides of the extension direction of the first wave rod 1113. The line connecting the geometric center of the first perforation 124 and the geometric center of the second perforation 125 is defined as W1. The intersection point of 1 and the first wave rod 1113 is Q. The tangent line passing through point Q and tangent to the wave rod is defined as W2. The included angle α between W1 and W2 satisfies: 60°≤α≤90° (the included angle between the two lines is in the range of 0°~90°). When the vertical distances between the first perforation 124 and the second perforation 125 and the first wave rod 1113 are both constant, if the included angle between W1 and W2 is too small, the line segment connecting the first perforation 124 and the second perforation 125 will be too long. When the first binding wire 41 is subjected to tensile force, it will be difficult to apply the main tensile force to the wave rod of the main wave ring 11, reducing the force on the edge of the membrane hole, which may lead to the enlargement of the membrane hole.

[0098] In one embodiment, the linear membrane 122 includes a first linear membrane 122a and a second linear membrane 122b. The first linear membrane 122a is disposed on the proximal side of the first perforation 124 and the second perforation 125, and the second linear membrane 122b is disposed on the distal side of the first perforation 124 and the second perforation 125. The included angle β1 between the first linear membrane 122a and W1 satisfies: 0°≤β1≤20°, so that the first linear membrane 122a can limit the proximal side of the first perforation 124 and the second perforation 125, avoiding... To prevent the membrane pores of the first perforation 124 and the second perforation 125 from expanding towards the proximal end; the included angle β2 between the second linear membrane 122b and W1 satisfies: 0°≤β2≤20° (for ease of identification of β1 and β2, the included angle between the parallel lines of the linear membrane 122b and W1 is indicated in the figure), so that the second linear membrane 122b can limit the distal end of the first perforation 124 and the second perforation 125, thus preventing the membrane pores of the first perforation 124 and the second perforation 125 from expanding towards the distal end.

[0099] The covered stent 100 can be implanted into tortuous blood vessels. When the covered stent 100 is implanted into a tortuous blood vessel, the first side 10a of the main stent 10 is defined as the side that conforms to the lesser curvature of the blood vessel, and the second side 10b of the main stent 10 is defined as the side that conforms to the greater curvature of the blood vessel. Taking the tortuous shape of the main stent 10 implanted in the aortic arch as an example, the first side 10a and the second side 10b of the main stent 10 are further explained. The first side 10a is the side of the main stent 10 away from the branch of the aortic arch (lesser curvature side), and the second side 10b is the side of the main stent 10 closer to the branch of the aortic arch (greater curvature side).

[0100] like Figure 9-12 As shown, the covered stent 100 may further include a branch stent 50, which is connected to one axial side of the main stent 10, and the lumen of the branch stent 50 is in communication with the lumen of the main stent 10. In this embodiment, as... Figure 9 As shown, the membrane 30a is connected to the first side 10a of the main support 10, and the branch support 50 is connected to the second side 10b of the main support 10. The branch support 50 can be located at the middle position of the circumferential arc of the second side 10b; combined with Figure 13 As shown, the main support 10 also includes multiple connectors 16. Connectors 16 connect two adjacent main corrugated coils 11. The connectors are located on the second side 10b of the main support 10. A connector 16 can be formed by one end of a main corrugated coil 11 extending to an adjacent main corrugated coil 11, or multiple separate connectors can connect two adjacent main corrugated coils 11 axially. The connectors 16 are continuously arranged axially at the circumferential center of the second side 10b. A branch support 50 is located on the circumferential central axis of the second side 10b. Some connectors are located on the same axial line as the branch support 50, making it easier for the film-coated support 100 to bend towards the first side 10a but less convenient to bend towards the second side 10b. Connectors near the branch support 50 can be located on both axial sides of the branch support 50 to avoid its position.

[0101] The main waveband 11 includes high and low wavebands. When the covered stent 100 is placed in a curved blood vessel, the high and low wavebands are positioned at the bend of the covered stent 100. In this embodiment, the main waveband 11 includes multiple high and low wavebands. The high and low wavebands include multiple consecutive short single waves disposed on the first side 10a and multiple consecutive high single waves disposed on the second side 10b. The axial spacing between the short waves of adjacent high and low wavebands is relatively large, which facilitates bending toward the first side 10a when the covered stent 100 is implanted into a curved blood vessel.

[0102] like Figure 9As shown, the main support 10 includes a proximal segment 10c, a curved segment 10d, and a distal segment 10e from the proximal end to the distal end. That is, the curved segment 10d is closer to the distal end than the proximal segment 10c. The flexibility of the first side 10a of the proximal segment 10c is less than that of the first side 10a of the curved segment 10d. The flexibility of the first side 10a of the distal segment 10e is less than that of the first side 10a of the curved segment 10d. This makes the curved segment 10d more likely to bend toward the first side 10a (here, flexibility refers to the characteristic that the covered support 100 is more flexible, which can be set by adjusting the interval distance between adjacent wave coils, with greater flexibility at the position where the interval distance between adjacent wave coils is larger; or by setting a connector to adjust its corresponding flexibility, with less flexibility at the position where the connector is set).

[0103] Combination Figure 10 As shown, when the covered stent 100 is implanted into a curved blood vessel, the curved segment 10d bends toward the first side 10a, causing the curved segments 10d of the first side 10a to stack. Since the capsule 30a is located on the first side 10a, if the capsule 30a does not have a fixed connection point at the proximal end segment 10c, after the covered stent 100 is released, the stacking of the curved segments 10d will cause the proximal edge of the capsule 30a to extend significantly beyond the proximal end of the main covered stent 12, thereby affecting the blood flow at the inflow end of the covered stent 100 and causing unnecessary risks.

[0104] like Figure 9 and Figure 11 Combination Figure 5 As shown, the binding attachment 111 includes a first binding attachment 111a and a second binding attachment 111b. The first binding attachment 111a is closer to the proximal end of the main support 10 than the second binding attachment 111b. The sheath 30a is connected to the main support 10 via a first binding thread 41 to the first binding attachment 111a, and via a second binding thread 42 to the second binding attachment 111b, thereby connecting the sheath 30a to the main support 10. In one embodiment, combined with... Figure 11 As shown, the first binding attachment 111a is positioned on the first side 10a of the proximal segment 10c. Since the positional change of the proximal segment 10c during implantation of the covered stent 100 into a curved vessel is only due to conforming to the curvature of the curved segment 10d, its own curvature is minimal. This means that the first side 10a of the proximal segment 10c experiences less stacking. Therefore, the edges between the main covering 12 and the corresponding capsule 30a portion from the perforation position corresponding to the first binding attachment 111a to the proximal end portion can remain flush before and after implantation. This prevents the proximal edge of the capsule 30a from significantly extending beyond the proximal side of the main covering 12, thus avoiding impact on blood flow at the inflow end of the covered stent 100. Figure 12As shown. That is, at least one binding attachment 111 is provided on the first side 10a of the proximal segment 10c so that the capsule and the main stent are fixedly connected at least once on the proximal segment. This ensures that the relative position of the capsule 30a portion on the proximal side from the fixed connection point to the corresponding main stent 10 of the proximal segment 10c remains almost unchanged before and after implantation. This avoids the situation where, after implantation into a tortuous blood vessel, the proximal edge of the capsule 30a significantly extends beyond the proximal side of the main cover 12 due to the stacking of the first side 10a of the tortuous segment 10d.

[0105] In this embodiment, such as Figure 11 As shown, the proximal segment 10c includes a first main wave loop 11a and a second main wave loop 11b from the proximal end to the distal end. The first main wave loop 11a is a small wave loop with a smaller wave height than other main wave loops 11. The second main wave loop 11b can be a small wave loop with a smaller wave height. The distal end of the proximal segment 10c is the circumferential surface where the trough of the second main wave loop 11b is located. The second main wave loop 11b can also be a high-low wave loop with the proximal end wave peaks aligned. The first side 10a of the second main wave loop 11b is a low wave and the second side 10b is a high wave. Then the distal end of the proximal segment 10c is the circumferential surface where the trough of the low wave of the second main wave loop 11b is located.

[0106] The curved segment 10d includes a third main wave coil 11c and a fourth main wave coil 11d sequentially from the proximal end to the distal end. Both the third main wave coil 11c and the fourth main wave coil 11d are high-low wave coils. The third main wave coil 11c can be a near-flat high-low wave coil or a far-flat high-low wave coil, and the fourth main wave coil 11d can also be a near-flat high-low wave coil or a far-flat high-low wave coil. This ensures that the axial spacing between adjacent wave coils on the first side 10a of the curved segment 10d is larger than that of the proximal end segment 10c or the distal end segment 10e, thus ensuring the flexibility of the first side 10a of the curved segment 10d and making it easier for the curved segment 10d of the covered stent 100 to bend towards the first side 10a. The near-flat high-low wave coil means that the peaks of the high and low waves are aligned on the proximal end side, and the far-flat high-low wave coil means that the troughs of the high and low waves are aligned on the distal end side.

[0107] In this embodiment, the third main waveband 11c is a near-flat high-low waveband, and the fourth main waveband 11d is a far-flat high-low waveband. The axial distance d1 between the trough of the first side 10a of the first main waveband 11a and the peak of the first side 10a of the second main waveband 11b is less than the axial distance d2 between the trough of the low wave of the first side 10a of the second main waveband 11b and the peak of the low wave of the first side 10a of the third main waveband 11c. In this embodiment, the first binding wire 41 is disposed on the wave rod, peak, or trough of the first side 10a of the first main waveband 11a, and the second binding wire 42 is disposed on the wave rod, peak, or trough of the first side 10a of the second main waveband 11b. Figure 7-7bAs shown, the first main wave coil 11a and the second main wave coil 11b are the main wave coils 11 used for connecting with the binding wire 40; in other embodiments, the first binding wire 41 is disposed on the wave rod, wave crest, or wave trough of the first side 10a of the first or second main wave coil 11b, and the second binding wire 42 is disposed on the wave rod, wave crest, or wave trough of the first side 10a of the third or fourth main wave coil 11d. In this case, the third main wave coil 11c connected with the first binding wire 41 includes a binding attachment 111, and the first main wave coil 11c connected with the second binding wire 42 includes a binding attachment 111. The third or fourth main body wave coil 11d also includes a binding accessory 111; it is only necessary to ensure that at least one connection position is provided on the first side 10a of the proximal segment 10c for the binding suture 40 to fix the connection, so that the relative position of the capsule 30a portion from the connection position to the proximal side and its corresponding main body stent 10 of the proximal segment 10c remains almost unchanged before and after implantation, thereby avoiding the situation where, after implantation into a tortuous blood vessel, the proximal edge of the capsule 30a significantly extends beyond the proximal side of the main body covering 12 due to the stacking of the first side 10a of the tortuous segment 10d.

[0108] like Figure 13-14a As shown, the main support 10 includes an annular support 13 and a window. The window is located on the side of the main support 10 and is used to communicate with the branch support 50. The annular support 13 is arranged along the window and is made of developing material. It is used to support the edge of the window and to show the position of the branch support 50.

[0109] The branch stent 50 includes a first end 51, a middle section 52, and a second end 53. The first end 51 and the second end 53 are oppositely arranged, and the middle section 52 is disposed between the first end 51 and the second end 53. The covered stent 100 also includes an annular connecting membrane 14, which connects the main stent 10 and the middle section 52 of the branch stent 50, thereby connecting the branch stent 50 to the main stent 10, such that the first end 51 of the branch stent 50 is located inside the lumen of the main stent 10, and the second end 53 of the branch stent 50 is located outside the lumen of the main stent 10. Figure 14-14a As shown.

[0110] The outer diameter of the branch stent 50 is smaller than the inner diameter of the annular support 13, and the radial width of the annular connecting membrane 14 is greater than the difference between the inner diameter of the annular support 13 and the outer diameter of the branch stent 50. This allows the annular connecting membrane 14 to allow the branch stent 50 to float vertically (radially) along the main stent 10. At the same time, the branch stent 50 can swing 360° along its tubular circumference, making the orientation of the opening at the second end of the branch stent 50 away from the main stent 10 adjustable. This makes it easier for the opening at the second end of the branch stent 50 to align with the branch vessel opening when using a guidewire to approach the branch vessel after the covered stent 100 is implanted into the blood vessel, thus reducing the impact of the complexity of the anatomical morphology on the correspondence between the opening at the second end of the branch stent 50 and the branch vessel opening. The annular connecting membrane connects the middle part of the branch support 50, so that part of the branch support 50 is located outside the main support 10 and part is located inside the main support 10. This ensures that the second end of the branch support 50 floats down to be flush with the main support 10. Within the range of the annular support, the orientation of the opening of the second end of the branch support 50 is adjustable, making it easier to adapt to different anatomical shapes.

[0111] The present invention also provides a support system 700, such as Figure 15 Combination Figure 20-22 As shown, the support system 700 includes the aforementioned covered support 100 and a conveyor 70. The conveyor 70 includes a sheath core assembly 71, a support rod 72, a sheath tube 73, a detachable bundle diameter member 74, and a handle assembly 75. The sheath core assembly 71 includes an inner sheath core 711 and an outer sheath core 712. The inner sheath core 711, outer sheath core 712, support rod 72, and sheath tube 73 are sequentially sleeved from the inside to the outside, and each pair of inner sheath cores 711, outer sheath cores 712, and sheath tube 73 can move relative to each other axially. The support rod 72 is sleeved on the outside of the sheath core assembly 71. The conveyor 70 also includes a guide head 76, which is disposed at the distal end of the inner sheath core 711. The distal end of the support rod 72 and the proximal end of the guide head 76 are spaced apart to form a loading space for the covered support 100. Figure 15 As shown, this illustration shows the internal components of the sheath 73 (the membrane support is omitted) for easier display of the internal structure of the sheath 73.

[0112] like Figure 16-16a As shown, the support rod 72 includes a first channel 721 and a second channel 722 that extend axially. The first channel 721 allows the sheath core assembly 71 to pass through axially, and the second channel 722 allows the bundle diameter guide wire 741 to pass through axially. Figure 16 As shown. In other embodiments, the support rod 72 may also include a third channel 723 through which the pre-placed conduit 79 passes axially, such as... Figure 16a As shown.

[0113] like Figure 17 Combination Figure 15As shown, the detachable bundle diameter member 74 may include a bundle diameter guide wire 741. The distal end of the detachable bundle diameter member 74 is sewn along the limiting holes 31 on the two long edges of the membrane 30a so that the membrane 30a can be opened to release the bracket. The proximal end of the detachable bundle diameter member 74 is connected to a safety buckle 743, which is detachably fixed to the handle assembly 75 to prevent the membrane bracket 100 from being accidentally released.

[0114] like Figure 17 As shown, the guide wire 741 is used to pass through the holes near the edges of the two long sides of the membrane 30a in a staggered manner along the axial direction, thereby wrapping the covered stent 100 inside the membrane 30a and radially compressing the covered stent 100 within the membrane 30a, so that the covered stent 100 is in a radially compressed bundled state. The distal end of the guide wire 741 is used to pass through the limiting holes 31 provided at the edges of the two long sides of the membrane 30a in a staggered manner along the axial direction, so as to enclose the membrane 30a into a tubular body, thereby radially compressing and constricting the covered stent 100 within the membrane 30a. The restriction of the guide wire 741 on the limiting holes 31 can be released by retracting the guide wire 741, thereby releasing the covered stent 100 from the compressed state and relieving the binding of the membrane 30a on the covered stent 100. The proximal end of the guide wire 741 is connected to a pull ring as a safety buckle 743. The pull ring is detachably fixed to the handle assembly 75. When it is necessary to release the covered support 100, first release the safety buckle 743 from the handle assembly 75, and then pull the safety buckle 743 back to open the film 30a, release the radial restraint on the covered support 100, and allow the covered support 100 to expand naturally.

[0115] like Figure 17 As shown, the stent system 700 also includes a branch sheath 77, which includes a wrapping portion 771, a hook portion 772, and a branch guide wire 773. The wrapping portion 771 is used to wrap the branch stent 50. The wrapping portion 771 is configured as a wrapping membrane with one open end and one closed end. The end of the wrapping portion 771 near the main stent 10 is open, and the end of the wrapping portion 771 away from the main stent 10 is closed. The hook portion 772 is located at the end of the wrapping portion 771 near the main stent 10, and the branch guide wire 773 is located at the end of the wrapping portion 771 away from the main stent 10. The hook portion 772 includes a loop for the guide wire 741 or the detachable suture structure 742 to pass through, so that the branch sheath 77 remains connected and fixed to the main stent 10 until the membrane 30a is opened to release the main stent 10. The branch guide wire 773 is used to assist the branch stent 50 of the covered stent 100 in accurately aligning with the branch vessel orifice.

[0116] In other implementations, such as Figure 18-19As shown, the releasable tension member 74 may also include a releasable suture structure 742, which passes axially through holes near the edges of the two long sides of the membrane 30a to radially compress the covered support 100 within the membrane 30a. The releasable tension member 74 is not limited here; it only needs to cooperate with the membrane 30a to achieve radial contraction and release of the covered support 100. Figure 18 As shown, the releasable suture structure 742 includes a restraining section 7421 and a guide section 7422. The restraining section 7421 sews the two long edges of the capsule 30a axially to form a tubular structure, facilitating the containment of the radially compressed covered support 100 within the capsule 30a. The guide section 7422 is formed by extending the restraining section 7421 beyond the capsule 30a. Pulling the guide section 7422 releases the restraint of the restraining section 7421 on the two long edges of the capsule 30a, allowing the capsule 30a to open and releasing the radial containment of the covered support 100. Figure 19 As shown.

[0117] In other embodiments, a branch sheath may not be provided, but a pre-embedded guidewire (not shown) may be provided. The support rod 72 includes a channel through which the pre-embedded guidewire passes axially. The pre-embedded guidewire is then used to select the branch vessel opening. Since it is difficult to directly select the branch vessel opening with a single guidewire, the pre-embedded guidewire can be captured by a guidewire catcher and enter the branch vessel.

[0118] The branch guidewire 773 can be pre-established by using a guidewire along the branch to allow it to pass through, or by using a guidewire catcher (not shown) to catch the branch guidewire 773 from the distal end of the delivery unit 70, thereby pulling one end of the branch guidewire 773 out of the body along the branch vessel, allowing the branch stent 50 to be precisely positioned at the branch vessel orifice. After the covered stent 100 is precisely released, an external extension stent 90 can be implanted as needed, with one end of the extension stent 90 (not shown) (closer to the branch stent 50) fitted into the branch stent 50, and the other end of the extension stent 90 (away from the branch stent 50) placed inside the branch vessel.

[0119] like Figure 15 As shown, the handle assembly 75 includes a fixed handle 751, a sliding handle 752, and a wing 753. The proximal end of the fixed handle 751 includes a guide rail 7511 extending proximally. The proximal end of the sheath 73 is connected to the sliding handle 752. The sliding handle 752 is positioned around the guide rail 7511 on one side of the proximal end of the fixed handle 751, allowing the sliding handle 752 to slide along the guide rail 7511, which can retract the sheath 73 to release the lumen support from the distal end of the sheath 73. The wing 753 is located on the proximal side of the catheter and has a channel communicating with a channel in the support rod 72 for the pre-placed catheter to pass through, facilitating the operation of the pre-placed catheter.

[0120] like Figure 20-22 As shown, the delivery device 70 also includes a rear-release structure for hooking the first bare wave coil 20, thereby realizing the rear release of the first bare wave coil 20 at the proximal end of the covered stent 100. The delivery device 70 includes a locking member 78 connected to the distal end of the outer sheath core 712; the locking member 78 includes multiple claws 781 and a connecting portion 782, and the proximal end of the guide head 76 is provided with a locking portion 761 and a locking groove 762; the multiple claws 781 radiate and disperse from the connecting portion 782 toward the distal end, and the connecting portion 782 fixes the multiple claws 781 at intervals to the distal end of the outer sheath core 712, wherein the multiple claws 781 can respectively engage with the locking portion 781. The slots 762 fit together; the locking part 761 is located on the distal side of the slot 762, and the locking part 761 includes a locking surface 7611 and a locking step 7612. The inner circumferential surface of the sheath 73 is fitted onto the locking surface 7611, and the distal end face of the sheath 73 abuts against the locking step 7612, so that the guide head 76 can be fitted and embedded into the distal end of the sheath 73, while the locking claw 781 and the mating part of the slot 762 are retracted into the sheath 73. It can be understood that the fit between the locking piece 78 and the slot 762 forms the above-mentioned detachable rear-release structure, that is, the rear-release structure includes the locking piece 78 and the slot 762. The locking piece 78 and the slot 762 fit together to form a closable state, and the locking piece 78 and the slot 762 are separated from each other to form an openable state. When in the closable state, the rear-release structure can temporarily fix the first bare wave coil 20 at the proximal end of the covered stent 100 before rear-release.

[0121] Taking the method of pre-establishing a branch access path along the branch to allow the branch guide wire 773 to pass through as an example, the surgical procedure of using the stent system 700 provided in this embodiment for aortic arch implantation is briefly summarized as follows:

[0122] The guidewire (not shown in the figure) is inserted along the branch vessel approach, from the proximal end of the aorta to the distal end, and finally exited through the femoral artery incision. Then, the guidewire is inserted through the branch vessel approach into the guiding cannula 81 and exited through the femoral artery. The guidewire is then removed, thus forming the following... Figure 23 The guide tube 81 shown is a passageway;

[0123] The ultra-rigid guidewire 82 is inserted into the ascending aorta, and the stent system 700 is introduced along the ultra-rigid guidewire 82. The stent system 700 is slowly introduced into the body along the ultra-rigid guidewire 82. Simultaneously, the branch guidewire 773 in the stent system 700 is introduced from the femoral artery into the branch vessel along the guiding catheter 81. The branch guidewire 773 is pulled out from the guiding catheter 81, and with the help of traction on the branch guidewire 773 and the guiding catheter 81, the distal end of the stent system 700 is introduced to the straight segment near the arch. Figure 24 As shown.

[0124] Continue pushing the stent system 700 along the ultra-rigid guidewire 82, delivering the distal end of the stent system 700 to the aortic arch for initial positioning. Then, withdraw the sheath 73 of the delivery device 70 to the distal end of the main stent 10, so that the covered stent 100, bound by the sheath 30a, is fully exposed from the sheath. Because the covered stent 100 is radially bound by the sheath 30a, the stent system 700 can still be adjusted along the ultra-rigid guidewire 82 after the sheath 73 is withdrawn, thereby positioning the covered stent 100. Precise positioning is performed, and the branch stent 50 is exposed after the sheath 73 is retracted. At this time, the branch guidewire 773 is pulled, and the main stent 10 is pushed and adjusted. With the assistance of the branch guidewire 773, the branch stent 50 is pulled into the branch vessel. Because the proximal end of the branch guidewire has a loop (hook 772) and the bundle diameter guidewire 741 hooking together, a certain amount of external force can be used. Through the traction force of the branch guidewire 773, the branch orifice of the covered stent 100 can be accurately aligned with the branch vessel. Figure 25-26 As shown.

[0125] like Figure 27-28 As shown, by pulling the guidewire 741 or the lead segment 7422 of the suture structure of the stent system 700 backward, the main stent 10 unfolds and adheres to the wall from the proximal end to the distal end, completely removing the guidewire 741 or the suture structure from the covered stent 100, the capsule 30a is fully opened, and the main stent 10 is basically completely adhered to the wall (except for the first bare wave loop 20 at the proximal end being hooked by the rear release structure). Furthermore, since the guidewire 741 or the suture structure is completely released and withdrawn, the interlocking fixation between the loop of the branch sheath 77 and the main stent 10 of the capsule 30a is released, and the branch guidewire 773 can be easily withdrawn. At this time, the branch stent 50 is fully unfolded and adheres to the branch vessel, such as... Figure 29 As shown.

[0126] The present invention also provides another support system 700, such as Figure 30 As shown, the stent system 700 includes the aforementioned covered stent 100, delivery device 70, and pre-placed catheter 79. The delivery device 70 includes the aforementioned sheath core assembly 71, support rod 72, sheath 73, detachable bundle diameter member 74, and handle assembly 75. That is, the stent system 700 includes all structures except the aforementioned branch sheath 77. In addition, as... Figures 31-33As shown, the stent system 700 also includes a pre-placed catheter 79, which extends along the lumen of the main stent 10 and is axially movable relative to the main stent 10. The distal end of the pre-placed catheter 79 can exit through the branch stent 50. The pre-placed catheter allows for direct selection of branch vessels without puncturing or cutting the other end of the branch vessel to capture the branch guidewire, reducing patient discomfort. It also avoids the problem of the guidewire easily becoming entangled with the ultra-rigid guidewire of the main stent during capture, reducing the surgical difficulty and time for the surgeon during branch selection.

[0127] The covered stent includes a semi-binding structure, which includes a wrapping element. This wrapping element can be either a film or a binding thread, both of which can be used to radially bind the main stent. When a pre-placed catheter is installed, the semi-binding structure can achieve semi-binding not only by using the film and the detachable bundle diameter element, but also by using the circumferentially spaced binding thread corresponding to the wave loops and cooperating with the bundle diameter guidewire. The natural straightening length W0 of the binding thread and the circumference of the covered stent 100 at the corresponding position in its naturally expanded state are C. The relationship between W0 and C satisfies: W0 ≤ C / 4.

[0128] Combination Figures 31-33 As shown, the pre-placed catheter 79 includes a straight section 791 and a pre-bent section 792. The pre-bent section 792 is located at the distal end of the straight section 791. A bend is formed at the connection between the straight section 791 and the pre-bent section 792. The pre-bending angle γ of the pre-bent section 792 relative to the straight section 791 satisfies the following range: 0°<γ≤60°. The pre-bending angle γ is the angle between the straight line containing the straight section 791 and the tangent line at the distal endpoint T of the center of the large bend side of the pre-placed catheter 79. A contrast-enhancing element 793 is provided at the distal end of the pre-placed catheter 79 to display the position of the distal end of the pre-placed catheter 79, facilitating the insertion of the distal end of the pre-placed catheter 79 into a branch vessel. The proximal end of the pre-placed catheter 79 extends beyond the proximal end of the handle assembly 75 and has a margin, facilitating adjustment of the pre-placed catheter 79 to select the branch vessel and also facilitating the direct insertion of a guidewire along the pre-placed catheter 79 into the branch vessel.

[0129] The support rod 72 also includes a third channel 723, which allows the pre-installed conduit 79 to pass through axially, such as... Figure 16a As shown.

[0130] like Figure 32As shown, the proximal end of the main support 10 includes a gap 15, and at least a portion of the pre-bent section 792 of the pre-placed conduit 79 extends beyond the proximal end of the main support 10. In this embodiment, the first bare wave coil 20 is hooked onto the rear release structure of the delivery device 70, and the gap 15 is formed between the wave rods of the first bare wave coil 20 hooked onto the rear release structure due to radial compression. In the delivery state, at least a portion of the pre-bent section 792 is embedded in the gap 15 to maintain the pre-bent shape of the pre-bent section. When the portion of the pre-placed conduit 79 exposed in the covered support is constricted in the sheath 73, the pre-bent shape of the pre-placed conduit 79 is straightened due to the compression between the covered support 100 and the sheath 73.

[0131] Another stent system, 700, is used for surgical procedures involving implantation in the aortic arch, and can be combined with... Figures 30-33 The conveyor diagram is summarized below:

[0132] like Figure 34 As shown, an ultra-rigid guidewire 82 is inserted into the ascending aorta to establish an access channel in the aortic arch. Then, a stent system 700 is introduced along the ultra-rigid guidewire 82. The stent system 700 is slowly introduced into the body along the ultra-rigid guidewire 82 until its distal end is inserted into the descending aorta. Figure 35 As shown.

[0133] By retracting the sliding handle 752, the sheath 73 is retracted to the distal end of the main stent 10, so that the main stent 10, which is bound by the membrane 30a, is exposed outside the sheath 73 in a state of being wrapped by the membrane 30a. Because the covered stent 100 is wrapped by the membrane 30a and radially bound, the stent system 700 can still continue to be adjusted along the ultra-rigid guidewire 82 after the sheath 73 is retracted, thereby accurately positioning the covered stent 100. The branch stent 50 and the pre-placed catheter 79 are exposed after the sheath 73 is retracted, such as Figure 36 As shown;

[0134] Rotate the proximal end of the pre-placed catheter 79 to disengage the pre-bent section 792 of the pre-placed catheter 79 from the gap 15 of the first bare wave loop 20. Then advance the pre-placed catheter 79 and insert it into the branch vessel (shown in the illustration as the left subclavian artery). Insert a branch rigid guidewire 83 along the pre-placed catheter 79 into the branch vessel. Figures 37-38 As shown;

[0135] like Figure 39 As shown, the stent system 700 is pushed forward until the annular support 13 is aligned with the left subclavian artery, and then the guidewire 741 is withdrawn backward, allowing the capsule 30a to open and the covered stent 100 to naturally expand to essentially adhere to the artery wall, as shown. Figure 40 As shown;

[0136] like Figure 41As shown, release the first bare wave coil 20, retract the pre-placed catheter 79 and delivery device 70, implant an external extension stent 90 along the branch rigid guidewire 83, and withdraw the branch rigid guidewire 83, as shown. Figure 42 As shown.

[0137] The stent system 700 provided in this embodiment, due to the setting of the pre-placed catheter 79, makes it easier to select branch vessels, thereby facilitating the selection of branch rigid guidewire 83 into branch vessels to establish branch access. This avoids the problem of difficulty in selecting branch vessels with guidewire, eliminates the need for an upper limb incision, and avoids guidewire entanglement, greatly reducing operation time. Furthermore, the pre-bent section 792 of the pre-placed catheter 79 can adapt to different anatomical shapes and is also suitable for anatomical shapes where the branch angle is too large to be easily selected. After the pre-placed catheter 79 selects the branch vessel, it can reduce the difficulty of selecting the branch rigid guidewire 83 into the branch vessel, thereby reducing operation time.

[0138] Due to the coordinated arrangement of the membrane 30a and the pre-placed conduit 79, when the covered stent 100 is wrapped inside the membrane 30a, a narrow and relatively uniform channel is formed inside the bound covered stent 100 for the pre-placed conduit 79 to pass through. Since there is no need for the sheath 73 to radially constrain the covered stent 100 outside the channel, the frictional force of the sheath 73 on the pre-placed conduit 79 can be reduced, making the delivery of the pre-placed conduit 79 smoother.

[0139] Meanwhile, the relationship between the width W of the membrane 30a and the lumen circumference C of the covered stent 100 at the corresponding position satisfies: W≤C / 4; this makes the compression radius of the covered stent in the semi-bound state small, that is, the radial compression degree of the covered stent is kept at a large level; on the one hand, it can ensure that the channel size is slightly larger than the outer diameter of the pre-placed catheter 79, so that the delivery of the pre-placed catheter 79 is smooth. Even if the corrugations of the radially compressed covered stent are crowded, the pre-placed catheter is placed in the covered stent. Due to the soft wrapping of the membrane, it can provide radial soft buffer, reduce the friction between the pre-placed catheter and the stacked main corrugations, and still ensure smooth delivery when axial delivery is required; on the other hand In terms of channel size, it can ensure that the channel size is not too large and limit the radial space of the pre-placed catheter 79, thus avoiding the pre-placed catheter 79 from bending in the channel during delivery. In addition, the radial compression of the covered stent 100 by the sheath 30a on the covered stent 100 is less frictional than the compression of the covered stent 100 by the sheath 73. Furthermore, since the wrapping of the main stent 10 by the sheath 30a is uniform in the axial direction of the main stent 10, it can also avoid the situation where, when the covered stent 100 is bundled with a wire, some unbound parts of the covered stent 100 are lifted up due to the self-expansion force of the main corrugated coil 11, resulting in a larger channel and the pre-placed catheter 79 bending in the larger channel space.

[0140] Understandably, in order to increase the radial compression of the membrane, the width W of the membrane 30a can be set to satisfy the following relationship with the lumen circumference C of the covered stent 100 at the corresponding position: W≤C / 5. Even if the channel space of the covered stent is small after the membrane wraps around it, since the membrane is a flexible membrane, its radial compression of the covered stent is a soft wrap. When the pre-placed catheter is placed in this space along the axial direction, the pre-placed catheter can slide smoothly along the axial direction in the narrow space. At the same time, the membrane radially squeezes the covered stent, which can prevent the pre-placed catheter from bending in the channel space.

[0141] Understandably, in one embodiment, the stent system 700 may further include a pre-placed guidewire disposed within a pre-placed catheter 79 and extending along the axial channel of the pre-placed catheter 79; the distal end of the pre-placed guidewire extends beyond the bend point of the pre-bent section 792 and the straight section 791, preventing the pre-bent section 792 from being embedded in the gap 15. If the pre-bent section 792 is kept bent, the passage at the bend point will become narrow, which would make it difficult for the guidewire to pass through the narrow channel at the bend point when it is introduced again in subsequent surgeries, thus increasing the difficulty of the surgery.

[0142] In other embodiments, the covered stent 100 provided by the present invention may further include an embedded stent 60, so that the covered stent can be used in cases where the aneurysm involves the left common carotid artery, such as... Figures 43-44 As shown, the covered stent 100 also includes another window, and the embedded stent 60 is disposed on the distal end side of the branch stent 50. The embedded stent 60 and the branch stent 50 are at least partially on the same axial line so that when the branch stent is located in the left common carotid artery, the window corresponding to the embedded stent 60 can face the left subclavian artery.

[0143] like Figures 43-44 The release process of the stent system corresponding to the provided covered stent is as follows: Figures 45-50 As shown, this stent system is used for surgical implantation in the aortic arch, and can be combined with... Figures 30-33 The conveyor diagram is summarized below:

[0144] The process of establishing aortic access and Figures 34-37The process is the same as above: the ultra-rigid guidewire 82 is inserted into the ascending aorta to establish an access channel in the aortic arch. Then, the stent system is introduced along the ultra-rigid guidewire 82. The stent system is slowly introduced into the body along the ultra-rigid guidewire 82 until the distal end of the stent system is introduced into the descending aorta. The sheath 73 is withdrawn to the distal end of the main stent 10 by withdrawing the sliding handle 752, so that the main stent 10, which is bound by the capsule 30a, is exposed outside the sheath 73 in a state of being wrapped by the capsule 30a. Since the covered stent 100 is wrapped by the capsule 30a and radially bound, the stent system can still be adjusted along the ultra-rigid guidewire 82 after the sheath 73 is withdrawn, so as to accurately position the covered stent 100. The branch stent 50 and the pre-placed catheter 79 are exposed after the sheath 73 is withdrawn.

[0145] Further, the proximal end of the pre-placed catheter 79 is rotated and slightly retracted, causing the pre-bent section 792 of the pre-placed catheter 79 to disengage from the gap 15 of the first bare wave loop 20. Then, the pre-placed catheter 79 is advanced and inserted into the left common carotid artery. A branch rigid guidewire 83 is then guided along the pre-placed catheter 79 into the branch vessel. Figure 45 As shown;

[0146] like Figure 46 As shown, the stent system is pushed forward until the annular support 13 is aligned with the left common carotid artery, and then the guidewire 741 is withdrawn, allowing the capsule 30a to open and the covered stent 100 to naturally expand to essentially adhere to the carotid wall, as shown. Figure 47 As shown;

[0147] like Figure 48 As shown, release the first bare wave coil 20, retract the pre-placed catheter 79 and delivery device 70, implant an external extension stent 90 along the branch guidewire 83, and withdraw the branch guidewire 83, as... Figure 49 As shown;

[0148] like Figure 50 As shown, an external small stent 91 is implanted along the embedded stent 60. One end of the small stent 91 partially overlaps and matches the embedded stent, so that the small stent 91 extends to the left subclavian artery.

[0149] It is understood that in other embodiments, the covered stent may also include two embedded stents, which can be used for cases where the aortic aneurysm involves the three branches of the aortic arch. The surgical procedure can be referred to the above procedure, and the branch stents can be aligned with the brachiocephalic trunk artery, which will not be described in detail here.

[0150] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0151] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A support system, characterized in that, Includes film-coated supports and delivery systems; The covered stent includes a main stent, a branch stent, and a wrapping component. The lumen of the branch stent is connected to the lumen of the main stent. The main stent includes a main corrugated coil and a main covering. The main covering covers the main corrugated coil. The wrapping component is connected to one side of the main stent. The wrapping component wraps the main stent to compress the main stent radially and can release the main stent to relieve its constraint. The width of the wrapping component at a certain position is defined as W. The perimeter of the covered stent at the position corresponding to the width W of the wrapping component when it is in a naturally expanded state is defined as C. Then the relationship between W and C satisfies: W ≤ C / 4. The delivery device includes a detachable bundle diameter member, which cooperates with the wrapping member to achieve radial convergence and release of the covered stent; the stent system also includes a pre-placed conduit, which extends along the cavity of the main stent and is axially movable relative to the main stent, and the distal end of the pre-placed conduit can pass through the branch stent.

2. The support system according to claim 1, characterized in that, The package is connected to the main support via a binding wire. The main support includes a binding accessory, which includes a portion of the main corrugated coil or a binding wire. The binding accessory extends along the main film. The main film includes a first perforation and a second perforation. The first perforation and the second perforation are respectively located on both sides of the extension direction of the binding accessory. The binding wire passes through the first perforation and the second perforation and crosses the binding accessory.

3. The support system according to claim 2, characterized in that, The binding wire is connected to the wave rod, wave crest, or wave trough of the main wave ring; Alternatively, one of the main wavering loops is connected by a steel sleeve in a wave-shaped ring, and the binding wire is connected to the main wavering loop, with the binding wire close to the edge of the steel sleeve.

4. The support system according to claim 2, characterized in that, The main body covering includes a linear film, which is wound around the circumference of the main body covering; The binding wire is connected to the wave rod of the main wave coil, and at least one linear membrane is provided on the proximal end and the distal end of the binding wire; Alternatively, the binding wire is connected to the crest of the main wave loop, and at least one linear membrane is provided on the distal end of the binding wire; Alternatively, the binding wire is connected to the trough of the main wave loop, and at least one linear membrane is provided on the distal end of the binding wire.

5. The support system according to claim 2, characterized in that, The main body covering includes a linear membrane, which is wound around the circumference of the main body covering; the shortest distance L1 of the linear membrane in the axial direction to the edge of the first perforation satisfies: L1≤3mm, and / or the shortest distance L2 of the linear membrane in the axial direction to the edge of the second perforation satisfies: L2≤3mm.

6. The support system according to claim 5, characterized in that, The package is configured as a wrapping film. The package includes a cushioning element, a third perforation, and a fourth perforation. The cushioning element extends along the plane of the package. The third perforation and the fourth perforation are respectively located on both sides of the extending direction of the cushioning element. The binding thread passes through the first perforation and the second perforation and crosses the binding attachment, then passes through the third perforation and the fourth perforation and crosses the cushioning element before being knotted.

7. The support system according to claim 1, characterized in that, The main support includes a first side and a second side along the circumferential direction. The package is connected to the first side of the main support by a binding wire, and the branch support is connected to the second side of the main support. The main support includes a proximal end segment, and at least one binding attachment is provided on the first side of the proximal end segment.

8. The support system according to claim 7, characterized in that, The proximal segment includes a first main wave loop and a second main wave loop from the proximal end to the distal end, and the binding wire includes a first binding wire and a second binding wire. The first binding wire is disposed on the wave rod, wave crest or wave trough on the first side of the first main wave ring, and the second binding wire is disposed on the wave rod, wave crest or wave trough on the first side of the second main wave ring. Alternatively, the main support includes a curved section, which is closer to the distal end than the proximal end. The curved section includes a third main wave loop and a fourth main wave loop sequentially from the proximal end to the distal end. The first binding wire is disposed on the wave rod, wave crest, or wave trough on the first side of the first main wave loop or the second main wave loop, and the second binding wire is disposed on the wave rod, wave crest, or wave trough on the first side of the third main wave loop or the fourth main wave loop.

9. The support system according to any one of claims 1-8, characterized in that, The conveyor includes a sheath core assembly, a support rod, and a sheath tube. The sheath core assembly includes an inner sheath core and an outer sheath core, which are sequentially sleeved from the inside to the outside. The support rod is sleeved outside the sheath core assembly. The conveyor also includes a guide head, which is disposed at the distal end of the inner sheath core. The distal end of the support rod and the proximal end of the guide head are spaced apart to form a loading space for the film-coated support.

10. The support system according to any one of claims 1-8, characterized in that, The pre-installed conduit includes a straight section and a pre-bent section, with the pre-bent section located at the distal end of the straight section.

11. The support system according to claim 10, characterized in that, At least a portion of the pre-bent section of the pre-placed conduit extends beyond the proximal end of the main support, the proximal end of the main support including a gap, wherein in the delivery state, at least a portion of the pre-bent section is embedded in the gap to maintain the pre-bent shape of the pre-bent section.

12. The stent system according to any one of claims 1-5 or 7-8, characterized in that, The package is made of a protective film.

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