Vascular stent with improved development performance and its embedded branch stent
By setting an annular developing part on the embedded branch stent of the vascular stent, the problem of difficulty in positioning and internal leakage of branch stents in the prior art is solved, and the accurate positioning and sealing connection of branch tubes are achieved, and surgical efficiency and safety are improved.
Patent Information
- Application Number
- CN201811438565.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2018-11-28
- Publication Date
- 2025-07-11
- Estimated Expiration
- 2038-11-28
AI Technical Summary
When treating arterial branches, it is difficult to accurately locate the shunt, resulting in endoscopy and prolonged surgical time, increasing the difficulty and risk of intraluminal treatment.
An embedded branch bracket that improves development performance is designed. By opening a window on the main body tube and setting an annular developing part at the proximal or distal end of the embedded branch tube, the position of the developing part is observed using the imaging equipment to ensure the accurate positioning and sealing connection of the branch tube to prevent internal leakage.
It improves the development performance of branch stents, simplifies the insertion process of branch tubes, reduces the risk of internal leakage, shortens the surgical time, and improves the surgical efficiency and success rate.
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Figure CN111227990B_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of implantable blood vessels, and particularly to a blood vessel stent with improved imaging performance and an embedded branch stent of the blood vessel stent. Background Art
[0002] An aortic aneurysm refers to local or diffuse abnormal dilation of the aortic wall, which compresses surrounding organs and causes symptoms. Rupture of the aneurysm is its main risk. It often occurs in the ascending aorta, aortic arch, descending thoracic aorta, thoracoabdominal aorta, and abdominal aorta. Aortic aneurysms can be classified into true aortic aneurysms and false aortic aneurysms according to their structure. Aortic aneurysms cause an increase in the medial pressure of the blood vessel, so they expand progressively. If they develop for a long time, they will eventually rupture. The larger the aneurysm, the greater the likelihood of rupture.
[0003] Aortic dissection is another serious aortic disease. Aortic dissection refers to the destruction of the middle layer of the thoracic aorta, bleeding within the blood vessel wall, and blood entering the space between the middle and outer layers of the blood vessel wall. Due to the impact of blood flow, once an aortic dissection forms, the tear can extend along the direction of blood flow, the dissection and false lumen expand, and the true lumen is compressed. Therefore, the risks that aortic dissection patients may face include: (1) being threatened by near-complete rupture of the blood vessel. Once the blood vessel completely ruptures, the mortality rate is extremely high; (2) the dissection gradually expands and compresses the true lumen, reducing blood supply to the distal part of the blood vessel. In most cases, aortic dissection is secondary to a thoracic aortic aneurysm or coexists with an aortic aneurysm. All aortic aneurysm diseases may involve branch arteries. Once branch arteries are involved, it will be extremely difficult to solve the problem through interventional methods. Currently, endovascular treatment has been carried out at home and abroad, that is, a minimally invasive method is used to implant a graft, namely an arterial covered stent, into the diseased artery through the blood vessel lumen to treat arterial diseases and improve blood supply, so as to achieve the treatment purpose. The so-called endovascular arterial covered stent is composed of a tubular rigid wire stent and an artificial blood vessel fixed on the outside of the stent. The tubular rigid wire stent is formed by folding elastic rigid wires into a ring after Z-shaped folding, and then multiple rings are sutured or adhered to the artificial blood vessel to form a tubular covered stent. When in use, the tubular covered stent is axially compressed and loaded into a delivery device, and the delivery device sends it to the diseased artery through the smaller femoral artery, iliac artery, or brachial artery and then releases it. Due to the elastic force of the metal wire stent, it automatically returns to a straight tubular shape and adheres tightly to the inner wall of the aorta, isolating the diseased part of the artery from the blood flow, thus achieving the treatment purpose.
[0004] In the prior art, commonly used stents for arterial branch treatment include chimney stents, integrated multi-branch stents, and window-type stents. These stents are limited by the structure of the stent and often need to be temporarily customized, or are prone to problems such as internal leakage. In addition, some split stents composed of multiple modules of a package include multiple shunt ports that can be connected to branch stents separated by a coating, and a sealing coating is provided on the end face of the coated stent away from the heart to prevent internal leakage between the multiple shunt ports on the end face. However, during use, the alignment and insertion between the branch stent and the shunt port often encounters difficulties, that is, when releasing multiple branch stents, it is difficult to find the shunt port corresponding to each branch stent, which increases the difficulty and time of intracavitary treatment using a multi-cavity coated stent, and may even easily lead to the failure of its intracavitary treatment. Summary of the invention
[0005] The object of the present invention is to provide an embedded branch stent which is convenient to use and has improved development performance, and a blood vessel stent provided with the embedded branch stent.
[0006] In order to solve the above technical problems, the present invention provides an embedded branch bracket with improved development performance, which includes a main body tube, the main body tube includes a tubular main body coating, and at least one window is provided on the main body coating. The embedded branch bracket also includes at least one embedded branch tube arranged in the inner cavity of the main body tube, the proximal end or distal end of at least one embedded branch tube is connected to at least one window, and at least one embedded branch tube is provided with at least one annular development portion.
[0007] The present invention also provides a vascular stent with improved development performance, including an embedded branch stent and at least one branch tube. The embedded branch stent includes a main body tube, the main body tube includes a tubular main body coating, and at least one window is provided on the main body coating. The embedded branch stent also includes at least one embedded branch tube arranged in the inner cavity of the main body tube, the proximal end or distal end of at least one embedded branch tube is connected to at least one window, and at least one embedded branch tube is provided with at least one annular development portion.
[0008] The embedded branch stent of the vascular stent provided by the present invention comprises a main body tube and at least one branch tube arranged in the inner cavity of the main body tube, and at least one annular developing portion is arranged on the embedded branch tube. When the branch tube needs to be connected to the embedded branch stent, the position of the annular developing portion can be clearly observed through imaging equipment, so that the branch tube can be conveniently and quickly inserted into the embedded branch. In addition, the embedded branch tube can seal the outer peripheral surface of the proximal end of the branch tube, so as to effectively prevent internal leakage. BRIEF DESCRIPTION OF THE DRAWINGS
[0009] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for the implementation will be briefly introduced below. Obviously, the accompanying drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other accompanying drawings can also be obtained based on these drawings.
[0010] Figure 1 It is a schematic structural diagram of a vascular stent provided by the first embodiment of the present invention.
[0011] Figure 2 It is Figure 1 a schematic structural diagram of the embedded branch stent in
[0012] Figure 3 It is Figure 2 a three-dimensional structural diagram of the annular corrugated support rod in
[0013] Figure 4 It is Figure 1 a schematic structural diagram of connecting the annular corrugated support rod to the main body membrane in
[0014] Figures 5a - 5c It is a schematic structural diagram of other forms of the embedded branch tube of the embedded branch stent of the present invention.
[0015] Figure 6 It is Figure 1 an enlarged view of the proximal part of the embedded branch stent in
[0016] Figure 7a And Figure 7b It is a schematic structural diagram of different developing structures around the fenestration of the embedded branch stent of the present invention.
[0017] Figure 8 It is a schematic structural diagram of the embedded branch stent of the vascular stent provided by the second embodiment of the present invention.
[0018] Figure 9 It is a schematic structural diagram of the embedded branch stent of the vascular stent provided by the third embodiment of the present invention.
[0019] Figure 10 It is a schematic structural diagram of the vascular stent provided by the fourth embodiment of the present invention.
[0020] Figure 11 It is a schematic structural diagram of the embedded branch stent of the vascular stent provided by the fifth embodiment of the present invention.
[0021] Figure 12 It is a schematic structural diagram of the embedded branch stent of the vascular stent provided by the sixth embodiment of the present invention.
[0022] Figure 13It is a usage state diagram of an embedded branch stent provided by the sixth embodiment of the present invention.
[0023] Figure 14 It is a schematic structural diagram of an embedded branch stent of a vascular stent provided by the seventh embodiment of the present invention.
[0024] Figure 15 It is Figure 14 a three-dimensional structural diagram of the proximal annular corrugated support rod in
[0025] Figure 16 It is Figure 14 a schematic structural diagram of one of the embedded branch tubes in
[0026] Figure 17 It is a usage state diagram of an embedded branch stent provided by the seventh embodiment. Detailed implementation manners
[0027] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.
[0028] In addition, the descriptions of the following embodiments refer to the attached drawings for exemplifying specific embodiments in which the present invention can be implemented. The directional terms mentioned in the present invention, such as "upper", "lower", "front", "rear", "left", "right", "inner", "outer", "side", etc., are only with reference to the directions of the attached drawings. Therefore, the directional terms used are for better and clearer illustration and understanding of the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus cannot be construed as a limitation of the present invention.
[0029] In the description of the present invention, the "proximal end" of the present invention refers to the end close to the heart position, and the "distal end" is the end far from the heart position. The high and low in the present invention are relative to the main body tube membrane. The end face exceeding the main body tube membrane is called high, and the end face not exceeding the main body tube membrane end face is called low. This definition is only for convenience of expression and cannot be construed as a limitation of the present invention.
[0030] Please refer to Figure 1 , Figure 1It is a schematic structural diagram of the vascular stent provided by the first embodiment of the present invention. The present invention provides a vascular stent 100 with improved imaging performance, which includes an embedded branch stent 20 and at least one branch tube 40. The embedded branch stent 20 includes a main body tube 21 and at least one embedded branch tube 25, and the main body tube 21 has an equal-diameter structure or a non-equal-diameter structure. The main body tube 21 includes a tubular main body membrane 210, and at least one of the embedded branch tubes 25 is disposed in the inner cavity of the main body tube 21 of the embedded branch stent 20. At least one window 211 is formed on the main body membrane 210, the distal end of at least one of the embedded branch tubes 25 is connected to at least one of the windows 211, and the proximal end of at least one of the embedded branch tubes 25 extends toward the proximal end of the main body tube 21. A ring-shaped imaging part is provided at the proximal end and / or the distal end of at least one of the embedded branch tubes 25. Specifically, the ring-shaped imaging part is located at the orifice of the proximal end and / or the distal end of at least one of the embedded branch tubes 25. During the operation, the position of the ring-shaped imaging part can be clearly observed through the imaging device. Therefore, it is more convenient and rapid to insert the branch tube 40 into the embedded branch 25.
[0031] In this embodiment, the main body tube 21 has a non-equal-diameter structure, the diameter of the proximal end of the main body tube 21 is larger than that of the distal end, and the diameter of the main body tube 21 gradually tapers from the proximal end to the distal end.
[0032] At least one of the embedded branch tubes 25 extends from at least one of the windows 211 into the inner cavity of the main body tube 21. The axis of the embedded branch tube 25 can be parallel or intersect with the axis of the main body tube 21. In this embodiment, the angle between the axis of the embedded branch tube 25 and the axis of the main body tube 21 is greater than 0 degrees.
[0033] The main body membrane 210 is a tubular structure, and the shape of its cross-section is a circle, an ellipse or a rhombus that matches the blood vessel. At least one of the windows 211 is formed on the tubular membrane, and the window 211 can be a circular hole, an elliptical hole, a rhombus hole or an irregular curved surface, etc. The main body membrane 210 is made of polyester cloth, PTFE, PET or other polymer materials.
[0034] Both the embedded branch stent 20 and the branch tube 40 are self-expanding stents. When the embedded branch stent 20 or the branch tube 40 is transported through a sheath tube, the diameter of the embedded branch stent 20 or the branch tube 40 can be contracted to a smaller state for transportation in the sheath tube; when the embedded branch stent 20 or the branch tube 40 is released in the blood vessel, the embedded branch stent 20 or the branch tube 40 can automatically expand to the required shape and size so that the embedded branch stent 20 or the branch tube 40 can support on the inner wall of the blood vessel lesion position, and the embedded branch stent 20 or the branch tube 40 exerts a radial supporting effect on the inner wall of the blood vessel, thereby being able to reconstruct the blood vessel.
[0035] The embedded branch stent 20 of the vascular stent 100 of the present invention includes a main body tube 21 and at least one branch tube 40 disposed in the inner cavity of the main body tube 21. A ring-shaped imaging portion is provided at the proximal end and / or the distal end of the embedded branch tube 25. When the branch tube 40 needs to be connected to the embedded branch stent 20, the position of the ring-shaped imaging portion can be clearly observed through an imaging device, so that the branch tube 40 can be conveniently and quickly inserted into the embedded branch 25, that is, the proximal end of the branch tube 40 is inserted into the inner cavity of the embedded branch tube 25, and the embedded branch tube 25 can hermetically wrap the outer peripheral surface of the proximal end of the branch tube 40, thereby effectively preventing endoleakage.
[0036] In this embodiment, since the angle between the axis of the embedded branch tube 25 and the axis of the main body tube 21 is greater than 0 degrees, the branch tube 40 is obliquely connected to the main body tube 21, which can prevent the branch tube 40 from being squeezed and bent, thereby preventing the branch tube 40 from being blocked.
[0037] Preferably, the angle between the axis of the embedded branch tube 25 and the axis of the main body tube 21 is 5 degrees, 45 degrees or a value within the range of 5 degrees to 45 degrees. Specifically, in the released state of the main body tube 21 and the embedded branch tube 25, the embedded branch tube 25 is obliquely connected to the main body tube 21, that is, the angle between the axis of the embedded branch tube 25 and the axis of the main body tube 21 is 5 degrees, 45 degrees or a value within the range of 5 degrees to 45 degrees. When a branch tube 40 is inserted into the embedded branch tube 25, the axis of the proximal end of the branch tube 40 coincides with the axis of the embedded branch tube 25, so that the branch tube 40 is obliquely connected to the main body tube 21.
[0038] In other embodiments, the angle between the axis of the embedded branch tube 25 and the axis of the main body tube 21 can be selected according to needs.
[0039] The axial extension length of the embedded branch tube 25 is greater than or equal to 2 mm. Preferably, the axial extension length of the embedded branch tube 25 is 2 mm, 100 mm or a value within the range of 2 mm to 100 mm. The inner diameter of the embedded branch tube 25 is greater than or equal to 2 mm. Preferably, the inner diameter of the embedded branch tube is 2 mm, 5 mm or a value within the range of 2 mm to 5 mm. The embedded branch tube 25 serves as an anchoring portion for connecting the main body tube 21 and the branch tube 40. The longer the axial extension length of the embedded branch tube 25, the longer the length of the sealed socket connection between the embedded branch tube 25 and the branch tube 40, and the more stable the connection of the proximal end portion of the branch tube 40 to the main body tube 21, thereby achieving a better anti-leakage effect.
[0040] Please refer toFigures 2 to 4 , Figure 2 is Figure 1 a schematic structural view of an embedded branch stent in Figure 3 is Figure 2 a three-dimensional structural view of a ring-shaped corrugated support rod in Figure 4 is a schematic structural view of connecting the ring-shaped corrugated support rod in 21 to the main body film. The main body tube 21 further includes a main body support framework 212 disposed on the inner circumferential surface or the outer circumferential surface of the main body film 210. Specifically, the main body support framework 212 is sutured to the inner circumferential surface or the outer circumferential surface of the main body film 210 by sutures. The main body support framework 212 may be an elastic metal support framework or an elastic non-metal support framework such as a polymer material. In this embodiment, the main body support framework 212 is a nickel alloy stent. When the main body support framework 212 is transported through a sheath tube, the diameter of the main body support framework 212 can be contracted to a smaller state for transportation in the sheath tube; when the main body support framework 212 is released in a blood vessel, the main body support framework 212 can automatically expand to the required shape and size so that the main body support framework 212 can support on the inner wall of the corresponding blood vessel.
[0041] The main body support framework 212 can be formed by laser cutting a nickel alloy tube or can be woven by metal wires such as nickel alloy wires. The density of the mesh structure of the main body support framework 212 is set according to needs. In this embodiment, the main body support framework 212 includes a plurality of ring-shaped corrugated support rods 2120 in a Z shape or a sine wave shape, and these ring-shaped corrugated support rods 2120 are arranged at intervals along the axial direction of the main body film 210, that is, these ring-shaped corrugated support rods 2120 are arranged in parallel with gaps in sequence from the proximal end to the distal end of the main body tube 21.
[0042] Each ring-shaped corrugated support rod 2120 can be an equal-height wave support rod or a high-low wave support rod, etc. The equal-height wave support rod means that the heights of the respective wave peaks on the ring-shaped corrugated support rod 2120 are the same, and the heights of the respective wave valleys are also the same, that is, the respective wave peaks and the respective wave valleys are in the same plane. The high-low wave support rod means that the heights of the respective wave peaks on the ring-shaped corrugated support rod 2120 are different, and the heights of the respective wave valleys can also be different. In this embodiment, the ring-shaped corrugated support rods 2120 of the main body tube 21 are all equal-height wave support rods.
[0043] Such as Figure 3As shown, each Z-shaped or sinusoidal waveform of each annular waveform support rod 2120 includes a wave crest 2121, a wave trough 2123, and a connecting rod 2125 connecting between the wave crest 2121 and the wave trough 2123. Each annular waveform support rod 2120 is woven by a superelastic nickel-titanium wire, and the selectable wire diameter (i.e., diameter) range of the superelastic nickel-titanium alloy wire is 0.2 mm to 0.5 mm. A connecting sleeve 2127 is provided on each annular waveform support rod 2120. The connecting sleeve 2127 connects the opposite ends of the annular waveform support rod 2120, that is, the opposite ends of the annular waveform support rod 2120 are both received in the connecting sleeve 2127, and then the two ends of the nickel-titanium wire are fixed inside the connecting sleeve 2127 by mechanical pressing or welding.
[0044] In this embodiment, the annular waveform support rod 2120 is woven by a nickel-titanium wire with a diameter of 0.4 mm, the number of Z-shaped or sinusoidal waves is 9, and the vertical height of the annular waveform support rod 2120 is 8-15 mm.
[0045] In other embodiments, the main support framework 212 may be a woven mesh structure or a cut mesh structure.
[0046] In other embodiments, the number of sinusoidal waves of the annular waveform support rod 2120 can be determined as needed, and the vertical height of the annular waveform support rod 2120 can be any height.
[0047] As Figure 4 shown, each annular waveform support rod 2120 of the main support framework 212 is sutured to the main covering film 210 by a suture 23, that is, the suture 23 can follow the waveform of each annular waveform support rod 2120 and accompany the entire main support framework 212. The suture 23 can also suture each annular waveform support rod 2120 to the main covering film 210 through a number of non-equidistantly distributed suture knots. The selectable diameter range of the suture 23 is 0.05 mm - 0.25 mm. Or the main support framework 212 can also be fixedly connected to the main covering film 210 by hot pressing.
[0048] The distal end of the embedded branch tube 25 is connected to the window 211, and the distal end face of the embedded branch tube 25 is flush with or not flush with the cross section of the window 211. When the distal end face of the embedded branch tube 25 is not flush with the cross section of the window 211, the embedded branch tube 25 and the window 211 are connected by a tubular transition coating 251. In this embodiment, the inward distance of the distal end face of the embedded branch tube 25 relative to the cross section of the window 211 is 0.5mm, 3mm or a value in the range of 0.5mm~3mm, that is, the axial length of the transition coating 251 is 0.5mm, 3mm or a value in the range of 0.5mm~3mm. The shape of the transverse end face of the transition coating 251 corresponds to the shape of the window 211, that is, it can be circular, elliptical or prismatic. The transition coating 251 extends from the window 211 toward the inner cavity of the main tube 21. One end of the transition coating 251 is sealed and connected to the edge of the window 211, and the other end of the transition coating 251 is sealed and connected to the proximal end of the embedded branch pipe 25, and the outer diameter of the proximal end of the transition coating 251 is greater than the outer diameter of the distal end. The transition coating 251 is made of polyester cloth, PTFE, PET or other polymer materials. Since the transition coating 251 is connected between the embedded branch 25 and the window 211, the transition coating 251 can be sealed and connected between the main coating 210 and the embedded branch 25, so that the main coating 210 can prevent internal leakage between the embedded branch 25 and the window 211. In another embodiment, the outer diameter of the distal end of the transition coating 251 is greater than the outer diameter of the proximal end, so that the transition coating forms an inner concave portion, and the inner concave portion has a guiding function. Or the cross section of the distal end of the transition coating 251 is concave inward relative to the window to form a guiding portion, so that the connection between the branch pipe 40 and the embedded branch pipe 25 is smoother.
[0049] In this embodiment, the proximal end of the transitional coating 251 is sutured to the main coating 210 at the edge of the window 211 by sutures, and the distal end of the transitional coating 251 is sutured to the distal end of the embedded branch tube 25 by sutures. The distal end of the transitional coating 251 can be an integral structure with the proximal end of the embedded branch tube 25.
[0050] In other embodiments, the connection between the proximal end of the transitional coating 251 and the main body coating 210 may be made by medical glue, and the connection between the distal end of the transitional coating 251 and the embedded branch tube 25 may also be made by medical glue.
[0051] In other embodiments, a support frame may be further provided on the transitional coating 251 to prop up the transitional coating 251. The support frame may be sutured to the inner circumference or outer circumference of the transitional coating 251 by sutures.
[0052] The embedded branch 25 includes a tubular embedded branch membrane 253 and a support framework 255 disposed on the embedded branch membrane 253, that is, the embedded branch membrane 253 is adhered to the inner circumferential surface or the outer circumferential surface of the support framework 255. Specifically, the support framework 255 is fixed to the inner circumferential surface, the outer circumferential surface or between multiple membranes of the embedded branch membrane 253 by suture or hot pressing. The shape of the transverse end surface of the embedded branch membrane 253 is circular, elliptical or rhombic that matches the proximal end of the branch tube 40, and the proximal end of the embedded branch membrane 253 is connected to the distal end of the transition membrane 251. The distal end of the embedded branch membrane 253 extends towards the inner cavity of the main body tube 21. In the released state, the angle between the axis of the embedded branch membrane 253 and the axis of the main body tube 21 is greater than 0 degrees. The main body membrane 210 is made of polyester cloth, PTFE, PET or other polymer materials.
[0053] The support framework 255 can be an elastic metal support framework or an elastic non-metal support framework such as a polymer material. In this embodiment, the support framework 255 is a nickel alloy stent. When the support framework 255 is transported through a sheath tube, the diameter of the support framework 255 can be shrunk to a smaller state for transportation in the sheath tube; when the support framework 255 is released, the support framework 255 can automatically expand to the required shape and size. The support framework 255 can support the embedded branch membrane 253 to keep the embedded branch membrane 253 in an open state, facilitating the connection of the branch tube 40.
[0054] The support framework 255 can be formed by laser cutting a nickel alloy tube or woven from metal wires such as nickel alloy wires. The density of the mesh structure of the support framework 255 is set as required. In this embodiment, the support framework 255 includes a plurality of Z-shaped or sinusoidal ring-shaped corrugated support rods, and these ring-shaped corrugated support rods are arranged at intervals along the axial direction of the embedded branch membrane 253, that is, these ring-shaped corrugated support rods are arranged in parallel with gaps in sequence from the proximal end to the distal end of the embedded branch membrane 253.
[0055] The inner diameter of the embedded branch 25 is less than or equal to the outer diameter of the proximal end of the branch tube 40. After the proximal end portion of the branch tube 40 passes through the window 211 and is inserted into the embedded branch 25 and released, the support framework 255 presses against the outer wall of the branch tube 40, making the connection between the branch tube 40 and the embedded branch 25 firmer and capable of maintaining the shape of the branch tube 40 entering the embedded branch 25; the embedded branch membrane 253 wraps around the outer circumferential surface of the proximal end of the branch tube 40, thereby further preventing internal leakage.
[0056] Please refer to Figures 5a to 5c , Figures 5a - 5cIt is a schematic structural diagram of other forms of the embedded branch of the embedded branch stent of the present invention. The embedded branch 25 can be selected from any annular support frame as shown in Figure 5a and 5b shown, or the Figure 5c shown mesh skeleton. The annular support frame includes a plurality of annular corrugated support rods in a Z shape or a sine wave shape, and these annular corrugated support rods are arranged at intervals along the axial direction of the embedded branch 25. The mesh skeleton can be made by weaving or cutting.
[0057] In other embodiments, the embedded branch 25 only includes the embedded branch membrane 253, that is, the support skeleton 255 on the embedded branch membrane 253 can be omitted, and the proximal end of the embedded branch membrane 253 is connected to the distal end of the transition membrane 251.
[0058] In other embodiments, the embedded branch 25 only includes the support skeleton 255, that is, the embedded branch membrane 253 on the support skeleton 255 can be omitted, and the support skeleton 255 is a bare stent, and the bare stent can be a bare stent with a woven or cut structure. The proximal end of the bare stent is connected to the distal end of the transition membrane 251.
[0059] In other embodiments, the embedded branch tube 25 includes an embedded branch membrane 253 directly connected to the fenestration 211. The embedded branch membrane 253 is hermetically connected to the main body membrane 210 except at the fenestration 211, and the embedded branch membrane 253 is used to wrap the proximal end of the branch tube 40. Specifically, the transition membrane 251 between the embedded branch tube 25 and the fenestration 211 can be omitted, and instead, the proximal end of the embedded branch membrane 253 is directly hermetically connected to the main body membrane 210 at the edge of the fenestration 211. The embedded branch membrane 253 is a tubular structure, and the shape of the cross-section of the embedded branch membrane 253 is the same as the shape of the fenestration 211, specifically circular, elliptical or rhombic, etc. An elastic embedded branch skeleton can be provided on the embedded branch membrane 253, and the embedded branch skeleton is attached to the inner circumferential surface or the outer circumferential surface of the embedded branch membrane 253. The embedded branch skeleton can make the connection of the branch tube 40 connected in the embedded branch tube 25 more firm and can maintain the shape of the branch tube 40 entering the embedded branch 25. In other embodiments, the embedded branch skeleton on the embedded branch membrane 253 can also be omitted.
[0060] Such as Figure 6As shown, a support member 214 is provided at the edge of the window opening 211. The support member 214 is used to expand the window opening 211 so that the window opening 211 remains in an open state. The support member 214 is a support rod fixed to the edge of the window opening 211. The support rod extends along the edge of the window opening 211, and the support rod adapts to the shape of the edge of the window opening 211. Specifically, the support rod can be a circular, elliptical or rhombic ring structure.
[0061] Preferably, the support member 214 is a support ring extending along the edge of the window opening 211, and the support ring has elasticity. When a branch pipe 40 is connected inside the window opening 211, the support ring can closely adhere to the outer surface of the branch pipe 40 to prevent internal leakage at the connection between the branch pipe 40 and the main body pipe 21. The support member 214 is made of a memory alloy, preferably a nickel-titanium alloy.
[0062] In this embodiment, a developing structure 215 is provided around the window opening 211 of the main body film 210. The developing structure 215 is a plurality of developing points arranged continuously or discontinuously along the edge of the window opening 211 on the main body film 210. These developing points can be fixed on the main body film 210 by means of sewing, stamping, inlaying or pasting. These developing points are arranged at least in one circle along the four edges of the window opening 211. The material of the developing structure 215 can be made of a material with good X-ray impermeability, strong corrosion resistance and good biocompatibility. The material of the developing member includes but is not limited to materials such as gold, platinum, tantalum, osmium, rhenium, tungsten, iridium, rhodium or alloys or composites of these metals. In this embodiment, the developing points are tantalum-containing nickel-titanium alloy metal sheets. The ring formed by these developing points is consistent with the shape of the window opening 211. Therefore, these developing points form a continuous or discontinuous ring-shaped developing mechanism. During the operation, the position of the developing structure 215 can be clearly observed through an imaging device, that is, it can be observed that the developing points near the window opening 211 are a ring-shaped developing mechanism around the edge of the window opening 211. Therefore, it is more convenient and fast to insert the branch pipe 40 into the embedded branch 25.
[0063] As Figure 7a shown, in other embodiments, the developing structure 215 is a developing wire continuously or discontinuously wound around the support member 214. The developing wire can be made of a tantalum-containing nickel-titanium alloy metal wire, and the diameter of the nickel-titanium alloy metal wire is 0.10 - 0.40 mm. Since the developing structure 215 has developability and is ring-shaped, the position of the developing structure 215 can be clearly observed through an imaging device during the operation, that is, it can be observed that the developing structure 215 is a ring-shaped developing structure around the edge of the window opening 211, rather than scattered developing points. Therefore, it is more convenient and fast to insert the branch pipe 40 into the embedded branch 25.
[0064] AsFigure 7b As shown, in other embodiments, the developing structure 215 is developing points continuously or intermittently fixed on the support 214, and the developing points are fixed on the support 214 by means of stitching, stamping, hot pressing, inlaying or pasting. These developing points are arranged around the support 214 for at least one turn.
[0065] In other embodiments, the support 214 is made of an alloy doped with a developing material, that is, the developing structure is the developing material fused in the support 214. The support 214 is formed by surrounding with a nickel-titanium alloy wire containing tantalum, and the wire diameter of the support 214 is 0.10 - 0.40 mm. Since the support 214 is made of an alloy containing a developing material, the support 214 can be directly used as the developing structure without additionally arranging a developing structure on the support 214. During the operation, the position of the support 214 can be clearly observed through the imaging device, and it is convenient and fast to insert the branch tube 40 into the fenestration 211, which is convenient to use.
[0066] In other embodiments, at least one turn of nickel-titanium alloy wire can be inlaid on the outer surface of the support 214, or at least one turn of nickel-titanium alloy wire can be pasted on the outer surface of the support 214. Preferably, tantalum wire is wound around the support 214.
[0067] As Figure 6 shown, support rings 256 are arranged at the pipe orifices at the proximal end and / or distal end of the embedded branch tube 25. The support rings 256 are used to expand the embedded branch film 253 to keep the embedded branch film 253 in an unfolded state, which is convenient for the insertion of the branch tube 40. The support rings 256 extend along the edge of the opening at the proximal end or distal end of the embedded branch film 253, and the support rings 256 adapt to the edge shape of the cross-section of the embedded branch tube 25. Specifically, the support rings 256 can be circular, elliptical or rhombic. The support rings 256 have elasticity. When the branch tube 40 needs to be connected in the fenestration 211, the support rings 256 can press the outer surface of the branch tube 40 to prevent internal leakage at the connection between the branch tube 40 and the embedded branch tube 25. The support rings 256 are made of a memory alloy, preferably nickel-titanium alloy.
[0068] The proximal end and / or the distal end of the embedded branch tube 25 is provided with an annular imaging part, and the annular imaging part is arranged around the circumferential direction of the embedded branch tube 25 for at least one turn. The annular imaging part can be arranged at the edge of the opening at the proximal end and / or the distal end of the embedded branch film 253, and the annular imaging part can also be the support ring 256 of the embedded branch tube 25. The annular imaging part arranged on the support ring 256 includes but is not limited to the following several types: On each support ring 256, imaging wires are connected or intermittently wound, such as tantalum-containing nitinol alloy wires, and the diameter of the nitinol alloy wires is 0.10-0.40 mm; Since the imaging wires on the support ring 256 have imaging properties and are annular, an annular imaging part is formed; During the operation, the position of the imaging wires on the support ring 256 can be clearly observed through the imaging device, so as to conveniently and quickly insert the branch tube 40 into the embedded branch 25. Secondly, imaging points are continuously or intermittently fixed on each support ring 256, and these imaging points enclose an annular imaging part, and these imaging points are fixed on the support ring 256 by means of sewing, stamping, hot pressing, inlaying or pasting. In addition, each support ring 256 can also be made of an alloy doped with an imaging material, such as tantalum-containing nitinol alloy wires, so that the support ring 256 itself forms an annular imaging part.
[0069] In a further preferred embodiment, the annular imaging structure 215 is simultaneously arranged at the window opening position or the distal end of the embedded branch tube, or simultaneously arranged at the proximal end and the distal end of the embedded branch tube, and the annular imaging structure 215 can adopt any of the above imaging structures. Through the two annular imaging at the proximal end and the distal end, it can help the surgeon quickly find the inlet and outlet of the branch tube during the operation, quickly establish the channel of the branch tube, greatly shorten the operation time, and improve the operation efficiency.
[0070] Please refer to Figure 8 , Figure 8 FIG. is a schematic structural diagram of an embedded branch stent provided by the second embodiment of the present invention. The structure of the embedded branch stent provided by the second embodiment of the present invention is similar to the structure of the first embodiment. The difference is that: in the second embodiment, the main support skeleton 212 of the main body tube 21 is provided with a small-wave-shaped support part 2122 at the proximal end and / or the distal end of the window 211, and the support part 2122 is used to better expand the window 211.
[0071] Specifically, the support portion 2122 is disposed on the peak and / or trough of the annular corrugated support rod 2120 adjacent to the window 211, such that the support portion 2122 is located at the proximal end and / or distal end of the window 211. When the support portion 2122 is disposed on the peak of the annular corrugated support rod 2120, the support portion 2122 includes a trough 2124 adjacent to the edge of the window 211, connecting rods 2128 located at opposite ends of the trough 2124, and peaks 2126 of the connecting rods 2125 of the corresponding annular corrugated support rod 2120 connected to the ends of each connecting rod 2128 away from the trough 2124. Since the trough 2124 and the two peaks 2126 are both adjacent to the proximal end of the window 211, the support portion 2122 can better expand the window 211, thereby reducing the deformation of the window 211 and facilitating the insertion of the branch tube 40 into the window 211.
[0072] As Figure 9 shown, Figure 9 FIG. is a schematic structural view of an embedded branch stent of a vascular stent provided by the third embodiment of the present invention. The structure of the embedded branch stent provided by the third embodiment of the present invention is similar to that of the second embodiment, except that: in the third embodiment, a small corrugated support portion is also provided at the distal end of the main body support frame 212 of the main body tube 21 at the window 211, and the support portion is disposed on the trough of the annular corrugated support rod 2120 adjacent to the window 211. Specifically, the support portion includes a peak 2126a adjacent to the distal edge of the window 211, connecting rods 2128a located at opposite ends of the peak 2126a, and troughs 2124a of the connecting rods 2125 of the corresponding annular corrugated support rod 2120 connected to the ends of each connecting rod 2128a away from the peak 2126a. Since the peak 2126a and the two troughs 2124a are both adjacent to the window 211, the support portion can better expand the window 211 and reduce the deformation of the window 211.
[0073] Please refer to Figure 10 , Figure 10 FIG. is a schematic structural view of an embedded branch stent provided by the fourth embodiment of the present invention. The structure of the embedded branch stent provided by the fourth embodiment of the present invention is similar to that of the first embodiment, except that: in the fourth embodiment, the main body tube 21a sequentially includes a proximal tube body 216, a middle tube body 217, and a distal tube body 218 from the proximal end to the distal end, and the diameter of the middle tube body 217 is smaller than that of the proximal tube body 216 and the distal tube body 218. A tubular main body film 210a is disposed on the inner circumferential surface or outer circumferential surface of the main body tube 21a, and the main body film 210a is made of polyester cloth, PTFE, PET, or other polymer materials.
[0074] The proximal tube body 216 includes a tubular proximal support skeleton 2160 adhered to the inner or outer peripheral surface of the main body film 210a. The proximal support skeleton 2160 includes a plurality of Z-shaped or sinusoidal proximal annular corrugated support rods 2161, and these proximal annular corrugated support rods 2161 are arranged at intervals along the axial direction of the main body film 210a. These proximal annular corrugated support rods 2161 can be equal-height wave support rods or high-low wave support rods. In this embodiment, the proximal annular corrugated support rods 2161 are woven from nitinol wires, the number of Z-shapes or sine waves can be determined as needed, and the vertical height of the proximal annular corrugated support rods 2161 can be any height.
[0075] The middle tube body 217 includes a tubular middle support skeleton 2170 adhered to the main body film 210a. The middle support skeleton 2170 includes a plurality of Z-shaped or sinusoidal middle annular corrugated support rods 2172, and these middle annular corrugated support rods 2172 are arranged at intervals along the axial direction of the main body film 210a. These middle annular corrugated support rods 2172 can be equal-height wave support rods or high-low wave support rods. In this embodiment, these middle annular corrugated support rods 2172 are all high-low wave support rods. The middle annular corrugated support rods 2172 are woven from nitinol wires, the number of Z-shapes or sine waves can be determined as needed, and the vertical height of the middle annular corrugated support rods 2172 can be any height. The diameter of the middle annular corrugated support rods 2172 is smaller than the diameter of the proximal annular corrugated support rods 2161.
[0076] The distal tube body 218 includes a tubular distal support skeleton 2180 adhered to the main body film 210a. The distal support skeleton 2180 includes a plurality of Z-shaped or sinusoidal distal annular corrugated support rods 2182, and these distal annular corrugated support rods 2182 are arranged at intervals along the axial direction of the main body film 210a. These distal annular corrugated support rods 2182 can be equal-height wave support rods or high-low wave support rods. In this embodiment, these distal annular corrugated support rods 2182 are all equal-height wave support rods. The distal annular corrugated support rods 2182 are woven from nitinol wires, the number of Z-shapes or sine waves can be determined as needed, and the vertical height of the distal annular corrugated support rods 2182 can be any height. The diameter of the distal annular corrugated support rods 2182 is larger than the diameter of the middle annular corrugated support rods 2172.
[0077] The distal end of the proximal tube body 216 is connected to the proximal end of the middle tube body 217 through a transition tube body 2164, and the proximal end of the distal tube body 218 is connected to the distal end of the middle tube body 217 through a second transition section 2184. The transition tube body 2164 is a main body film 210a connected between the distal end of the proximal support framework 2160 and the proximal end of the middle support framework 2170. The main body film 210a at the transition tube body 2164 includes a connection area 2165 extending in a direction perpendicular to the axis of the main body tube 21a. At least one window 211 is provided on the connection area 2165. At least one embedded branch tube 25 is provided in the proximal tube body 216. One end of the embedded branch tube 25 is hermetically connected to the edge of the window 211, and the opposite end of the embedded branch tube 25 extends towards the proximal end of the proximal tube body 216. The axis of the embedded branch tube 25 may be parallel or intersect with the axis of the main body tube 21a. In this embodiment, the axis of the embedded branch tube 25 is parallel to the axis of the main body tube 21a. The structure of the embedded branch tube 25 is the same as that in the first embodiment and will not be described in detail here.
[0078] In this embodiment, the embedded branch tube 25 can be connected to the edge of the window 211 through a transition film, or the tubular embedded branch film of the embedded branch tube 25 is directly connected to the edge of the window 211. The specific structure and connection method are the same as those in the first embodiment and will not be described in detail here.
[0079] Supports may be provided around the window 211 on the connection film 2165. The supports are the same as the supports 214 in the first embodiment and will not be described in detail here.
[0080] A developing structure may be provided at the proximal end and / or the distal end position of the embedded branch tube 25 on the connection film 2165. The developing structure is the same as the developing structure 215 in the first embodiment and will not be described in detail here.
[0081] The second transition section 2184 is conical, and it includes a connection area 2185 of the main body film 210a connecting the proximal end of the distal support frame 2180 and the distal end of the middle support frame 2170, and a transition support rod 2186 disposed on the connection area 2185 of the connecting main body film 210a. The transition support rod 2186 is a conical corrugated support rod. The proximal diameter of the transition support rod 2186 is smaller than the distal diameter. The proximal end of the transition support rod 2186 is adjacent to the distal end of the middle support frame 2170, and the distal end of the transition support rod 2186 is adjacent to the proximal end of the distal support frame 2180. The main body film 210a at the second transition section 2184 is conical, that is, the connection area 2185 is conical. The connection film 2165, the main body film 210a at the middle tube body 217, and the main body film 210a at the second transition section 2184 enclose a concave space 2175, and the concave space 2175 is used to accommodate the branch tube 40 inserted into the window 211 on the connection film 2165, so as to provide enough space for the branch tube 40 and prevent the main body tube 21a from squeezing the branch tube 40, thereby avoiding the blockage of the branch tube 40.
[0082] Please refer to Figure 11 , Figure 11 FIG. is a schematic structural diagram of an embedded branch stent provided by the fifth embodiment of the present invention. The structure of the embedded branch stent provided by the fifth embodiment of the present invention is similar to the structure of the fourth embodiment. The difference is that: in the fifth embodiment, at least one window 211 is opened on the connection area 2165, and at least one embedded branch tube 25 is disposed in the proximal tube body 216 corresponding to at least one of the windows 211. The distal end of at least one of the embedded branch tubes 25 is hermetically connected to the edge of at least one of the windows 211 through a transition film 251a. Specifically, the proximal end of the transition film 251a is connected to the periphery of the distal end of the embedded branch tube 25, and the distal edge of the transition film 251a is hermetically connected to the edge of the window 211. The structure of the embedded branch tube 25 in this embodiment is the same as that in the first embodiment, and will not be described in detail here.
[0083] The transition film 251a is in a conical ring shape, that is, the outer diameter of the distal end of the transition film 251a is larger than the outer diameter of the proximal end, so that the transition film 251a forms an inverted funnel-shaped concave portion 2512, and the concave portion 2512 has a guiding function. When the proximal end of the branch tube 40 passes through the window 211 and is inserted into the embedded branch tube 25, the concave portion 2512 can guide the branch tube 40 to be inserted into the embedded branch tube 25 to facilitate the insertion of the branch tube 40.
[0084] In this embodiment, at least one embedded branch tube 25 is also disposed in the middle tube body 217. Specifically, at least one window 211 is formed on the main body film 210a at the proximal end of the middle tube body 217. At least one of the windows 211 corresponds to the concave space 2175. At least one embedded branch tube 25 is disposed in the middle tube body 217 corresponding to at least one of the windows 211. The distal end of at least one of the embedded branch tubes 25 is hermetically connected to the edge of the window 211 through a transition film 251a. The outer diameter of the distal end of the transition film 251a is larger than that of the proximal end, so that the transition film 251a forms an inwardly concave portion in an inverted funnel shape. The inwardly concave portion has a guiding function to facilitate the insertion of the branch tube 40 into the embedded branch tube 25.
[0085] The middle annular corrugated support rods 2172 on the middle tube body 217 are equal-height wave support rods. These equal-height wave support rods are arranged at intervals along the axial direction of the main body film 210a. The wave crests and wave troughs between two adjacent middle annular corrugated support rods 2172 correspond to each other, so that a rhombus area with a relatively large area is formed between the wave crest and the wave trough. The rhombus area facilitates the formation of the window 211.
[0086] In other embodiments, the cross section of the distal end of the transition film 251a is recessed 0.5-3 mm inward relative to the window 211 to form a guiding portion. The guiding portion facilitates the insertion of the branch tube 40 into the embedded branch tube 25.
[0087] In other embodiments, the cross section of the distal end of the embedded branch film 253 of the embedded branch tube 25 is recessed 0.5-3 mm inward relative to the cross section of the window 211 to form a guiding portion. The guiding portion facilitates the insertion of the branch tube 40 into the embedded branch tube 25.
[0088] Please refer to Figure 12 , Figure 12 , which is a schematic structural diagram of the embedded branch stent provided by the sixth embodiment of the present invention. The structure of the embedded branch stent provided by the sixth embodiment of the present invention is similar to that of the fourth embodiment. The difference is that: in the sixth embodiment, the main body tube 21b includes a proximal tube body 216 at the proximal end and a connecting tube body 219 connected to the distal end of the proximal tube body 216. The diameter of the proximal tube body 216 is larger than that of the connecting tube body 219. A tubular main body film 210b is disposed on the inner peripheral surface or the outer peripheral surface of the main body tube 21b. The main body film 210b is made of polyester cloth, PTFE, PET or other polymer materials.
[0089] The proximal tube body 216 includes a tubular proximal support framework 2160 adhered to the main body film 210b. The proximal support framework 2160 includes a plurality of proximal annular corrugated support rods 2161 in a Z shape or a sine wave shape, and these proximal annular corrugated support rods 2161 are arranged at intervals along the axial direction of the main body film 210b. These proximal annular corrugated support rods 2161 can be equal-height wave support rods or high-low wave support rods.
[0090] The connecting tube body 219 includes a tubular connecting support framework 2190 adhered to the main body film 210b. The connecting support framework 2190 includes a plurality of annular corrugated support rods 2192 in a Z shape or a sine wave shape, and these annular corrugated support rods 2192 are arranged at intervals along the axial direction of the main body film 210b. These annular corrugated support rods 2192 can be equal-height wave support rods or high-low wave support rods. The diameter of the annular corrugated support rods 2192 is smaller than the diameter of the proximal annular corrugated support rods 2161.
[0091] The distal end of the proximal tube body 216 and the proximal end of the connecting tube body 219 are connected through a transition section. The transition section is the main body film 210b connected between the distal end of the proximal support framework 2160 and the proximal end of the connecting support framework 2190. The main body film 210b at the transition section includes a connecting area 2165 extending in a direction perpendicular to the axis of the main body tube 21b. At least one window 211 is formed on the connecting area 2165. At least one embedded branch tube 25 is arranged in the proximal tube body 216. One end of the embedded branch tube 25 is hermetically connected to the edge of the window 211, and the opposite end of the embedded branch tube 25 extends toward the proximal end of the proximal tube body 216. The axis of the embedded branch tube 25 is parallel to or intersects with the axis of the main body tube 21a. In this embodiment, the axis of the embedded branch tube 25 is parallel to the axis of the main body tube 21a. In this embodiment, two windows 211 are formed on the connecting area 2165, and two embedded branch tubes 25 are arranged in the proximal tube body 216. The distal ends of the two embedded branch tubes 25 are respectively hermetically connected to the edges of the two windows 211. The structure of the embedded branch tube 25 is the same as that in the first embodiment, and will not be described in detail here.
[0092] At least one embedded branch tube 25 is provided at the proximal end of the connecting tube body 219. At least one window 211 is formed in the main body film 210b at the proximal end of the connecting tube body 219. The distal end of the embedded branch tube 25 is hermetically connected to the edge of the window 211, and the proximal end of the embedded branch tube 25 extends toward the proximal tube body 216. The angle between the axis of the embedded branch tube 25 and the axis of the main body tube 21b is greater than 0 degrees. Preferably, the angle between the axis of the embedded branch tube 25 and the axis of the main body tube 21b is 5 degrees, 45 degrees, or a value within the range of 5 degrees to 45 degrees.
[0093] Please refer to Figure 13 , Figure 13 FIG. is a diagram showing the use state of the embedded branch stent provided by the sixth embodiment. Three branch tubes 40, or small braided branch tubes, or other branch tubes are connected to the main body tube 21b. During use, the branch tubes 40 or other branch tubes can be respectively released into the three embedded branch tubes 25 of the main body tube 21b. The diameter of each embedded branch tube 25 is smaller than the diameter of the proximal end of the corresponding branch tube 40, small braided branch tube, or other branch tubes, so that the embedded branch tube 25 can compress the branch tube 40, small braided branch tube, or other branch tubes, and make the branch tube 40, small braided branch tube, or other branch tubes fit against the inner wall of the embedded branch tube 25 to prevent internal leakage; the branch tubes 40, small braided branch tubes, or other branch stents can be received in the concave space 2175 on the main body tube 21b to avoid stent stacking.
[0094] During release, the delivery device is pushed along the super-stiff guide wire to push the pre-mounted main body tube 20 to the position of the thoracic aortic dissection lesion, and positioning is performed through the imaging ring at the front end and the imaging point at the proximal end of the main body tube 20. By controlling the delivery device, the main body tube 20 is released; then, the delivery device is pushed along the super-stiff guide wire to push the pre-mounted branch tube 40 or other branch tubes to be adjacent to the main body tube 20. The proximal end of the branch tube 40 or other branch tubes is inserted into the corresponding embedded branch tube 25 through the window 211 by the imaging structure around the window 211 and the annular imaging part on the embedded branch tube 25, and the branch tube 40 or other branch tubes are released. The embedded branch tube 25 compresses the branch tube 40 or other branch tubes, so that the released branch tube 40 or other branch tubes are hermetically connected to the embedded branch tube 25 to prevent internal leakage.
[0095] Please refer to Figure 14 , Figure 14It is a schematic structural diagram of the embedded branch stent provided by the seventh embodiment of the present invention. The structure of the embedded branch stent provided by the seventh embodiment of the present invention is similar to that of the fourth embodiment, and the differences are as follows: In the seventh embodiment, the main body tube 21c sequentially includes a proximal tube body 216, a middle tube body 217, and a distal tube body 218 from the proximal end to the distal end. The diameter of the middle tube body 217 is smaller than that of the proximal tube body 216 and the distal tube body 218. A tubular main body film 210c is disposed on the inner circumferential surface or the outer circumferential surface of the main body tube 21c, and the main body film 210c is made of polyester cloth, PTFE, PET or other polymer materials. The distal end of the proximal tube body 216 is connected to the proximal end of the middle tube body 217 through a conical transition tube body 2176; the proximal end of the distal tube body 218 is connected to the distal end of the middle tube body 217 through a conical second transition section 2178. An inner concave space 2175 is formed on the outer circumferential surface of the middle tube body 217 between the proximal tube body 216 and the distal tube body 218. The inner concave space 2175 is used to accommodate the branch tube 40 inserted into the window 211 on the main body tube 21c, so as to provide sufficient space for the branch tube 40, prevent the main body tube 21c from squeezing the branch tube 40 or the branch tubes 40 from stacking, thereby avoiding the blockage of the branch tube 40.
[0096] The proximal tube body 216 includes a tubular proximal support skeleton 2160 attached to the inner circumferential surface or the outer circumferential surface of the main body film 210c. The proximal support skeleton 2160 includes a plurality of proximal annular corrugated support rods 2161 in a Z shape or a sine wave shape, and these proximal annular corrugated support rods 2161 are arranged at intervals along the axial direction of the main body film 210c. These proximal annular corrugated support rods 2161 can be equal-height wave support rods or high-low wave support rods. In this embodiment, window support portions 2162 for supporting the window 211 are respectively provided on two proximal annular corrugated support rods 2161.
[0097] As Figure 15 shown, Figure 15 is Figure 14Schematic three-dimensional structure diagram of the proximal ring-shaped corrugated support rod. Each Z-shaped or sinusoidal waveform of the proximal ring-shaped corrugated support rod 2161 provided with a window support part 2162 includes a wave crest 2163, a wave trough 2167, and a connecting rod 2168 connecting between the wave crest 2163 and the wave trough 2167. Each proximal ring-shaped corrugated support rod 2161 is woven by a superelastic nickel-titanium wire, and the selectable wire diameter (i.e., diameter) range of the superelastic nickel-titanium alloy wire is 0.2 mm to 0.55 mm. A connecting sleeve is provided on each proximal ring-shaped corrugated support rod 2161, and the connecting sleeve connects the opposite ends of the proximal ring-shaped corrugated support rod 2161, that is, the opposite ends of the proximal ring-shaped corrugated support rod 2161 are received in the connecting sleeve, and then the two ends of the nickel-titanium wire are fixed inside the connecting sleeve by mechanical pressing or welding. The window support part 2162 is provided on one of the wave troughs 2167 of the proximal ring-shaped corrugated support rod 2161, that is, the window support part 2162 is located between two adjacent wave crests 2163. The window support part 2162 is a V-shaped or U-shaped support rod, and the opposite ends of the support rod are respectively connected to the corresponding connecting rods 2168, and a window space 2169 is formed between the window support part 2162 and the corresponding two connecting rods 2168 and the wave crest 2163.
[0098] In this embodiment, two proximal ring-shaped corrugated support rods 2161 with window support parts 2162 are provided on the proximal tube body 216, and the two proximal ring-shaped corrugated support rods 216 are evenly arranged on the proximal tube body 216, and their window support parts 2162 reserve enough space for the window 211. The wire diameter of the proximal ring-shaped corrugated support rod 2161 is 0.45 mm, the number of wave crests 2163 provided on the proximal ring-shaped corrugated support rod 2161 is 6, and the vertical height of the proximal ring-shaped corrugated support rod 2161 is 15 mm.
[0099] The middle tube body 217 includes a tubular middle support skeleton adhered to the main body film 210c, and the middle support skeleton includes at least one Z-shaped or sinusoidal middle ring-shaped corrugated support rod 2172, and the middle ring-shaped corrugated support rods 2172 are arranged at intervals along the axial direction of the main body film 210c. The middle ring-shaped corrugated support rod 2172 can be an equal-height wave support rod or a high-low wave support rod. In this embodiment, only one middle ring-shaped corrugated support rod 2172 is provided on the middle tube body 217, and the middle ring-shaped corrugated support rod 2172 is an equal-height wave support rod. The diameter of the middle ring-shaped corrugated support rod 2172 is smaller than the diameter of the proximal ring-shaped corrugated support rod 2161.
[0100] The distal tube body 218 includes a tubular distal support framework attached to the main body membrane 210c. The distal support framework includes at least one Z-shaped or sinusoidal distal annular corrugated support rod 2182, and the distal annular corrugated support rods 2182 are arranged at intervals along the axial direction of the main body membrane 210c. The distal annular corrugated support rods 2182 can be support rods with equal-height waves or support rods with high and low waves. In this embodiment, only one distal annular corrugated support rod 2182 is provided on the distal tube body 218, and the distal annular corrugated support rod 2182 is a support rod with equal-height waves. The diameter of the distal annular corrugated support rod 2182 is larger than the diameter of the middle annular corrugated support rod 2172.
[0101] On the inner surface or the outer surface of the main body membrane 210c at the transition tube body 2176, there is provided a Z-shaped or sinusoidal conical corrugated support rod 2177. The diameter of the proximal end of the conical corrugated support rod 2177 is larger than that of the distal end. The proximal end of the conical corrugated support rod 2177 is adjacent to the distal end of the proximal tube body 216, and the distal end of the conical corrugated support rod 2177 is adjacent to the proximal end of the middle tube body 217. The diameter of the conical corrugated support rod 2177 gradually increases from the distal end towards the proximal end, that is, the diameter of the proximal end of the conical corrugated support rod 2177 is equivalent to the diameter of the proximal support framework 2160, and the diameter of the distal end of the conical corrugated support rod 2177 is equivalent to the diameter of the middle annular corrugated support rod 2172.
[0102] On the inner surface or the outer surface of the main body membrane 210c at the second transition section 2178, there is provided a Z-shaped or sinusoidal conical corrugated support rod 2179. The diameter of the proximal end of the conical corrugated support rod 2179 is smaller than that of the distal end. The proximal end of the conical corrugated support rod 2179 is adjacent to the distal end of the middle tube body 217, and the distal end of the conical corrugated support rod 2179 is adjacent to the proximal end of the distal tube body 218. The diameter of the conical corrugated support rod 2179 gradually decreases from the distal end towards the proximal end, that is, the diameter of the proximal end of the conical corrugated support rod 2179 is equivalent to the diameter of the middle annular corrugated support rod 2172, and the diameter of the distal end of the conical corrugated support rod 2179 is equivalent to the diameter of the distal annular corrugated support rod 2182.
[0103] On the main body film 210c of the proximal tube body 216, two fenestrations 211 are provided corresponding to the fenestration spaces 2169 of the two fenestration support parts 2162. The line connecting the centers of the two fenestrations 211 is parallel to the axis of the main body tube 21c. Among them, the fenestration 211 adjacent to the proximal end of the proximal tube body 216 is of a groove type structure, and the groove can be a square, U-shaped or semi-circular structure. The edge of the fenestration 211 is provided with a square, U-shaped or semi-circular support rod; the fenestration 211 adjacent to the distal end of the proximal tube body 216 is circular or elliptical, and the edge of the fenestration 211 is provided with a support ring, and the support ring is preferably a ring made of shape memory metal. A developing structure is also provided on the fenestration 211, and the developing structure is the same as the developing structure 215 in the first embodiment, so it will not be elaborated here.
[0104] Two embedded branch tubes are arranged in the proximal tube body 216, and the proximal ends of the two embedded branch tubes are respectively sealed and connected to the two fenestrations 211 on the proximal tube body 216. The embedded branch tubes in this embodiment have the same structure as the embedded branch tubes 25 in the first embodiment, so it will not be elaborated here.
[0105] Please refer to Figure 15 and Figure 16 , on the opposite sides of the main body film 210a at the transition tube body 2176, two fenestrations 211 are respectively provided, that is, the two fenestrations 211 are symmetric about the axis of the main body tube 21c; the edge of each fenestration 211 includes a V-notch. Two of the embedded branch tubes 25 are arranged in the transition tube body 2176, and the distal ends of the two embedded branch tubes 25 are respectively sealed and connected to the edges of the two fenestrations 211, and the opposite proximal ends of the embedded branch tubes 25 extend towards the proximal end of the proximal tube body 216. The axis of the embedded branch tube 25 is parallel or intersects with the axis of the main body tube 21c. In this embodiment, the axis of the embedded branch tube 25 is parallel to the axis of the main body tube 21c. A support member and a developing structure are also provided on each fenestration 211. Except that the support member is provided with a V-shaped structure corresponding to the V-shaped notch of the fenestration 211, the others are the same as the support member 256 in the first embodiment. The developing structure on the fenestration 211 is also the same as that in the first embodiment, so it will not be elaborated here. Each embedded branch tube 25 in the transition tube body 2176 includes an embedded branch film 253a, a support skeleton 255a and a support ring 256a, and the support ring 256a includes a V-shaped structure corresponding to the V-shaped notch of the corresponding fenestration 211. Except for the structure corresponding to the V-shaped notch of the fenestration 211, the structure of the embedded branch tube 25 in this embodiment is the same as that of the embedded branch tube 25 in the first embodiment, so it will not be elaborated here.
[0106] Please refer to Figure 17 , Figure 17It is a usage state diagram of the embedded branch stent provided by the seventh embodiment. Four branch pipes 40, or small braided branch pipes, or other branch branch pipes are connected to the main body pipe 21c. During use, the branch pipes 40 or other branch branch pipes can be respectively released into the four embedded branch pipes 25 of the main body pipe 21c. The diameter of each embedded branch pipe 25 is smaller than the diameter of the proximal end of the corresponding branch pipe 40, small braided branch pipe, or other branch branch pipes, so that the embedded branch pipe 25 can compress the branch pipe 40, small braided branch pipe, or other branch branch pipes, and make the branch pipe 40, small braided branch pipe, or other branch branch pipes fit against the inner wall of the embedded branch pipe 25 to prevent internal leakage; the branch pipe 40, small braided branch pipe, or other branch branch pipes can be received in the concave space 2175 on the main body pipe 21c to avoid stent stacking.
[0107] During release, push the delivery device along the super-stiff guide wire to push the pre-installed embedded branch stent to the position of the aortic dissection lesion, and position it through the imaging ring at the front end of the embedded branch stent. By controlling the delivery device, release the embedded branch stent; then, push the delivery device along the super-stiff guide wire to push the pre-installed branch pipe 40 or other branch branch pipes to be adjacent to the embedded branch stent. The proximal end of the branch pipe 40 or other branch branch pipes passes through the corresponding window 211 and is inserted into the embedded branch pipe 25 through the imaging structure around the window 211 and the annular imaging part on the embedded branch pipe 25, that is, release the branch pipe 40 or other branch branch pipes. The embedded branch pipe 25 compresses the branch pipe 40 or other branch branch pipes to make the released branch pipe 40 or other branch branch pipes be hermetically connected to the embedded branch pipe 25 to prevent internal leakage. At this time, two embedded branch pipes 25 on the proximal pipe body 216 and two embedded branch pipes 25 on the transition pipe body 2176 are respectively inserted with branch pipes 40. The two branch pipes 40 connected to the proximal pipe body 216 can be respectively located in the celiac trunk and the superior mesenteric artery, and the branch pipe 40 connected to the transition pipe body 2176 can be located in the renal aorta.
[0108] The above is the implementation manner of the embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the embodiments of the present invention, several improvements and refinements can be made, and these improvements and refinements are also regarded as the protection scope of the present invention.
Claims
1. An embedded branch stent for improving the developing performance, which comprises a main body tube. The main body tube includes a tubular main body film, and at least one window is formed on the main body film. It is characterized in that, The embedded branch stent further includes at least one embedded branch tube disposed in the inner cavity of the main tube, at least one proximal end or distal end of the at least one embedded branch tube is connected to at least one of the fenestrations, and at least one annular visualization part is disposed on the at least one embedded branch tube; The main tube further includes a main support framework disposed on the inner peripheral surface or outer peripheral surface of the main membrane, the main support framework includes a plurality of annular corrugated support rods, and small corrugated support parts are disposed at the proximal end and distal end of the fenestration, and the support parts are used to better expand the fenestration; the support part at the proximal end of the fenestration is disposed on the peak of the annular corrugated support rod adjacent to the proximal end of the fenestration, and includes a trough adjacent to the proximal end of the fenestration, connecting rods located at opposite ends of the trough, and a peak of the connecting rod adjacent to the proximal end of the fenestration and connected to the peak of the corresponding annular corrugated support rod at one end of each connecting rod away from the trough; the support part at the distal end of the fenestration is disposed in the trough of the annular corrugated support rod adjacent to the distal end of the fenestration, and includes a peak adjacent to the distal end of the fenestration, connecting rods located at opposite ends of the peak, and a trough of the connecting rod adjacent to the distal end of the fenestration and connected to the trough of the corresponding annular corrugated support rod at one end of each connecting rod away from the peak.
2. The inlaid branch stent according to claim 1, characterized in that, At least one proximal end and / or distal end of the at least one embedded branch tube is provided with an annular visualization part, or the annular visualization part is disposed at the orifice of the fenestration.
3. The embedded branch stent according to claim 2, characterized in that The annular visualization part includes a support member and a visualization member.
4. The embedded branch stent according to claim 3, wherein, The support member is a support ring.
5. The embedded branch stent according to claim 4, wherein The visualization member is a visualization wire continuously or intermittently wound around the support ring; Or visualization points continuously or intermittently disposed on the support ring; or a visualization material doped in the production material of the visualization part; Or a plurality of visualization points disposed around the fenestration.
6. The embedded branch stent according to claim 1, wherein The embedded branch tube includes an embedded branch membrane, and the distal end of the embedded branch membrane is hermetically connected to the edge of the main membrane except for the fenestration, and the embedded branch membrane is used to wrap the branch tube.
7. The embedded branch stent according to claim 6, wherein The cross-section of the distal end of the embedded branch membrane is concave inward relative to the fenestration to form a guiding part, and the guiding part facilitates the insertion of the branch tube into the embedded branch tube.
8. The embedded branch stent according to claim 1, characterized in that, The main tube is an equal-diameter structure or a non-equal-diameter structure.
9. The embedded branch stent according to claim 8, wherein, The main tube is a non-equal-diameter structure, the diameter of the proximal end of the main tube is larger than that of the distal end, and the diameter of the main tube gradually tapers from the proximal end to the distal end.
10. The embedded branch stent according to claim 8, wherein The main tube sequentially includes a proximal tube body, a middle tube body and a distal tube body from the proximal end to the distal end, and the diameter of the middle tube body is smaller than that of the proximal tube body and / or the distal tube body.
11. The embedded branch stent according to claim 10, wherein The fenestration is opened on the main membrane at the junction of the proximal tube body and the middle tube body, or on the main membrane at the middle tube body.
12. The embedded branch stent according to claim 11, characterized in that, The embedded branch tube is disposed in the inner cavity of the proximal tube body, the inner cavity of the middle tube body and / or the inner cavity of the distal tube body.
13. The embedded branch stent according to any one of claims 1-12, characterized in that, The axis of the embedded branch tube is parallel to the axis of the main tube.
14. The embedded branch stent according to claim 1, wherein The distal end of the embedded branch tube is connected to the fenestration, and the distal end face of the embedded branch tube is flush or not flush with the cross-section of the fenestration.
15. The embedded branch stent according to claim 14, wherein A transition membrane is connected between the distal end of the embedded branch tube and the cross-sectional edge of the fenestration, and the transition membrane is hermetically connected to the main body membrane.
16. The embedded branch stent according to claim 1, wherein The main body tube includes a proximal tube body and a distal tube body. The distal end of the proximal tube body is connected to the proximal end of the distal tube body by a transition tube body. The transition tube body is a conical tube, and the diameter of the proximal end of the transition tube body is larger than that of the distal end. The embedded branch tube is disposed in the inner cavity of the transition tube body, and a fenestration is formed in the main body membrane at the connection of the embedded branch tube to the transition tube body.
17. The embedded branch stent according to claim 16, wherein, Two of the embedded branch tubes are disposed in the inner cavity of the transition tube body, and fenestrations are respectively formed on opposite sides of the axis of the transition tube body in the main body membrane at the transition tube body. The two embedded branch tubes are respectively connected to the two fenestrations.
18. A vascular stent, characterized in that, It includes the embedded branch stent according to any one of claims 1 to 17, and at least one branch tube. The proximal end portion of the at least one branch tube is connected to the inside of the embedded branch tube of the embedded branch stent.
19. The vascular stent according to claim 18, wherein, The inner diameter of the embedded branch tube is less than or equal to the outer diameter of the proximal end of the at least one branch tube. When the at least one branch tube is inserted into the embedded branch tube, the embedded branch tube compresses the at least one branch tube.
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