CN107789094B - Artificial blood vessel without sewing stent - Google Patents
Artificial blood vessel without sewing stent Download PDFInfo
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- CN107789094B CN107789094B CN201711177857.0A CN201711177857A CN107789094B CN 107789094 B CN107789094 B CN 107789094B CN 201711177857 A CN201711177857 A CN 201711177857A CN 107789094 B CN107789094 B CN 107789094B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/064—Blood vessels with special features to facilitate anastomotic coupling
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Gastroenterology & Hepatology (AREA)
- Pulmonology (AREA)
- Prostheses (AREA)
Abstract
The invention discloses a suture-free stent artificial blood vessel, relates to the technical field of medical instruments, and aims to solve the problems of blood leakage and complications caused by difficult anastomosis and overlong anastomosis time of the conventional artificial blood vessel. The invention relates to a suture-free stent artificial blood vessel, which comprises: the artificial blood vessel body consists of a textured part artificial blood vessel and a non-textured part artificial blood vessel which are connected in sequence, and a compressible elastic metal stent is sewed on the non-textured part artificial blood vessel; the thread-making part artificial blood vessel is provided with a stitch-free connecting part which consists of a soft annular pocket and a super-elastic braided fixing ring, wherein the soft annular pocket is positioned on the outer side of the thread-making part artificial blood vessel and is coaxially and seamlessly connected with the thread-making part artificial blood vessel, the super-elastic braided fixing ring is arranged between the soft annular pocket and the thread-making part artificial blood vessel, and a height restraining device is arranged on the super-elastic braided fixing ring along the elastic direction; the super-elastic woven fixing ring is of a grid structure which is staggered up and down and is woven by super-elastic nickel-titanium alloy wires.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a suture-free stent artificial blood vessel.
Background
Aortic dissection is a disease of aorta with risk, rapid progression and high mortality, with an incidence of about 0.3%, untreated early mortality increasing by 1% per hour and more than 50% of patients dying within 1 week. Aortic dissections are rapidly ill and after recovery are extremely poor, and even viable patients continue to develop chronic aortic dissections with a variety of clinical manifestations. The position of the rupture of the aortic dissection is a core factor for determining the operation mode, the rupture is positioned in the descending aorta, namely the B-type dissection, and the aortic intraluminal repair technology has gradually become a new treatment standard for treating the aortic dissection by replacing most of the traditional thoracoabdominal surgery because of small wound, high success rate, good treatment effect and quick postoperative recovery. For lesions adjacent to or affecting major branch vessels that must be preserved, such as type a dissections involving the ascending aorta and aortic arch, it is now common practice to replace the diseased artery with an artificial blood vessel by surgical means.
In 1983, Borst first proposed the replacement of the ascending aorta and aortic arch, and placed a free artificial blood vessel in the descending aorta, and during the second thoracic descending aorta, he called the trunk surgery, the technique, which can be performed remotely in the left subclavian artery without the need for deep hypothermia arrest. The improved trunk operation technology proposed by crawford and svensson in the early 90 s not only makes the implantation of the artificial blood vessel easier and has less bleeding complications, but also further increases the contact area between the implanted artificial blood vessel and the aortic wall and reduces the operative mortality of the aortic dissection to 5%. In 2003, Sunrihong and the like used four-branch artificial vascular aortic arch replacement and bracket elephant nose surgery to treat the Stanford A-type aortic dissection have obtained good clinical effect and become the classic surgical treatment of the Stanford A-type aortic dissection.
At present, the conventional procedures of aortic arch replacement and bracket trunk operation are that an infusion tube is arranged in an axillary artery, and upper and lower vena cava drainage tubes are arranged in the right atrium to establish cardiopulmonary bypass; cooling to below 32 deg.C, blocking ascending aorta, cutting the ascending aorta, and perfusing cardioplegia solution through the left and right coronary artery openings to arrest heart; continuing cooling while performing ascending aorta replacement or Bental l or David; the temperature of nasopharynx is reduced to 18 ℃, circulation is stopped, innominate artery, left common carotid artery and left subclavian artery are blocked in sequence, and selective cerebral perfusion is carried out on axillary artery; incising the aortic arch, and incising the aorta transversely between the left common carotid artery and the innominate artery; releasing the stent graft within the descending aorta; anastomosing the distal end of the four-branch artificial blood vessel, the proximal end of the covered stent and the proximal end of the descending aorta; after the anastomosis is finished, connecting the artery perfusion tube with perfusion branches of the four-branch artificial blood vessel, blocking the proximal end of the perfusion branches of the artificial blood vessel, and recovering the perfusion of the lower half body; and (3) sequentially enabling the four-branch artificial blood vessel to coincide with the row ends of the left subclavian artery, the left common carotid artery and the innominate artery, opening the left common carotid artery after the left common carotid artery is coincided, recovering cerebral perfusion, and simultaneously beginning rewarming. Then the proximal ends of the four branch artificial blood vessels are anastomosed with the ascending aorta; opening the ascending aorta, and automatically or electrically repeating the heart; and (5) continuing rewarming, auxiliary circulation, stopping the machine, stopping bleeding and closing the chest according to the conventional method.
Aortic replacement surgery is one of the most challenging problems in thoracic heart surgery, mainly manifested by great difficulty, high mortality, and high incidence of postoperative complications. Debakey reports that the operative mortality rate of the dissecting aneurysm reaches as high as 40% in the early years, mainly related to bleeding caused by the low blood vessel anastomosis technology, along with the improvement of the operative skill and the improvement of extracorporeal circulation and cerebral perfusion methods, the total operative mortality rate is reduced but still reaches about 5-15%, and serious patients, particularly patients with aortic arch surgery or serious complications can even reach 50-70%. The operation needs to be carried out under extracorporeal circulation, and the aortic arch part or descending aorta must be affected by adopting a deep low temperature circulation stopping technology, namely, the body temperature is reduced to about 15 ℃, the blood circulation of the whole body is stopped, and the vascular anastomosis is completed in a bloodless environment.
The inventor of the present application finds that the problems in the prior art include: the surgical field is difficult to expose, the aorta vessels have lesions of different degrees, the interlayer is bleeding, the vessel wall is thin and crisp, and the oozing and leaking of blood at the anastomotic stoma are always very troublesome problems after the large vessel surgery; the anastomosis time is long, the operation needs to be carried out in an extracorporeal circulation state, the circulation stopping state is needed in the descending aorta anastomosis process, the anastomosis time directly influences the extracorporeal circulation time, the circulation stopping time and the temperature, the extracorporeal circulation and the deep low temperature circulation stopping are in non-physiological states, and particularly the deep low temperature circulation stopping has certain safety time limit.
Disclosure of Invention
The invention aims to provide a suture-free stent artificial blood vessel, which aims to solve the technical problems of blood leakage and complications caused by difficult anastomosis and overlong anastomosis time of the artificial blood vessel in the prior art.
The invention provides a suture-free stent artificial blood vessel, which comprises: the artificial blood vessel comprises an artificial blood vessel body, a blood vessel core and a blood vessel core, wherein the artificial blood vessel body consists of a textured part artificial blood vessel and a non-textured part artificial blood vessel which are sequentially connected, and a compressible elastic metal support is sewed on the non-textured part artificial blood vessel; the thread-making part artificial blood vessel is provided with a stitch-free connecting part, the stitch-free connecting part consists of a soft annular pocket which is positioned on the outer side of the thread-making part artificial blood vessel and is coaxially and seamlessly connected with the thread-making part artificial blood vessel, and a super-elastic weaving fixing ring which is placed between the soft annular pocket and the thread-making part artificial blood vessel, and a height restraining device is arranged on the super-elastic weaving fixing ring along the elastic direction; the super-elastic woven fixing ring is of a grid structure which is staggered up and down and is woven by super-elastic nickel-titanium alloy wires.
During the practical application, be located exempt from to seam the outside of connecting portion, correspond the elastic metal support just closes on solid fixed ring department is woven to super bullet is provided with the compression membrane cover.
The diameter of the super-elastic braided fixing ring is slightly larger than that of the textured part artificial blood vessel, and the interference magnitude is 10% -40%.
Specifically, the super-elastic braided fixing ring is formed by braiding super-elastic nickel-titanium alloy wires, and the cross section of each wire is circular, and the diameter of each wire is 0.30-0.40 mm.
Specifically, the superelastic braided fixing ring is braided by superelastic nickel-titanium alloy wires, and the cross section of each wire is rectangular.
Furthermore, the super-elastic woven fixing ring is of a grid structure which is staggered up and down, the grid structure is a rhombic grid, and the width and the height of the rhombic grid are respectively 2mm-5 mm.
Furthermore, the super-elastic braided fixing ring is braided by super-elastic nickel-titanium alloy wires, the number of braided wire materials is 1-4, and the braiding method is one-up one-down or two-up two-down.
In practical application, the artificial blood vessel at the non-textured part is in a straight cylinder type or conical type structure.
Wherein the artificial blood vessel of the textured part is provided with a branch artificial blood vessel.
Compared with the prior art, the suture-free stent artificial blood vessel has the following advantages:
the invention provides a suture-free stent artificial blood vessel, which comprises: the artificial blood vessel comprises an artificial blood vessel body, a blood vessel core and a blood vessel core, wherein the artificial blood vessel body consists of a textured part artificial blood vessel and a non-textured part artificial blood vessel which are sequentially connected, and a compressible elastic metal stent is sewed on the non-textured part artificial blood vessel; the thread-making part artificial blood vessel is provided with a stitch-free connecting part which consists of a soft annular pocket and a super-elastic braided fixing ring, wherein the soft annular pocket is positioned on the outer side of the thread-making part artificial blood vessel and is coaxially and seamlessly connected with the thread-making part artificial blood vessel, the super-elastic braided fixing ring is arranged between the soft annular pocket and the thread-making part artificial blood vessel, and a height restraining device is arranged on the super-elastic braided fixing ring along the elastic direction; the super-elastic woven fixing ring is of a grid structure which is staggered up and down and is woven by super-elastic nickel-titanium alloy wires. According to the analysis, in the suture-free stent-graft provided by the invention, because the proximal end of the stent-graft is textured, the distal end of the stent-graft is not textured, and the non-textured part is sutured with the elastic metal stent, the non-textured stent-graft and the textured part of the stent-graft are integrally designed, a doctor does not need to anastomose the stent-graft and the textured part of the stent-graft at the operation site, so that the operation steps are effectively simplified, and the probability of blood leakage at the aortic orifice of the aorta is greatly reduced.
In addition, in the sewing-free stent artificial blood vessel provided by the invention, the proximal end of the artificial blood vessel is textured, the distal end of the artificial blood vessel is not textured, and the non-textured part is sewn with the compressible elastic metal stent, so that the probability of blood leakage of the descending aorta anastomosis opening can be effectively reduced due to the integrated design. The outer side of the artificial blood vessel pattern-making part is provided with a soft annular pocket without blood leakage, and the soft annular pocket can be used for being tightly attached and connected with the broken end of the autologous blood vessel of the descending aorta through a mechanical locking part to prevent blood leakage; the anastomotic stoma is positioned at the outer side of the artificial blood vessel and cannot be directly impacted by the blood flow and the pressure difference of the active artery, the area of mechanical locking is far larger than the continuous anastomotic area, the pressure on the blood vessel is more average, the probability of blood leakage due to blood vessel tearing is greatly reduced, the mechanical locking piece improves the anastomotic speed, the aorta blocking and circulation stopping time is shortened, the incidence and the death rate of central nervous system complications can be effectively reduced, the operation difficulty is reduced, the operation is simple and easy to master, the operation is facilitated, more patients benefit, and the incidence rate of the related complications of anastomotic stoma bleeding is effectively reduced.
The invention also provides a super-elastic braided fixing ring, wherein a height restraining device is arranged on the super-elastic braided fixing ring along the elastic direction; the super-elastic woven fixing ring is of a grid structure which is staggered up and down, and the grid structure is a rhombic grid; the superelastic braided fixing ring is formed by braiding superelastic nickel-titanium alloy wires, and the cross sections of the wires are circular or rectangular.
Compared with the prior art, the super-elastic woven fixing ring has the following advantages:
in the super-elastic braided fixing ring provided by the invention, a height restraining device is arranged on the super-elastic braided fixing ring along the elastic direction; the super-elastic weaving fixing ring is of a grid structure which is staggered up and down, and the grid structure is a rhombic grid; and the superelastic braided fixing ring is braided by a superelastic nickel-titanium alloy wire, and the cross section of the wire is circular or rectangular. From this analysis it can be seen that:
1. the super-elastic woven fixing ring has the advantages of being matched with the diameter of a blood vessel, the fixing ring with the non-adjustable diameter needs to obtain a good sealing effect, the diameter of the blood vessel needs to be matched with the diameter of the fixing ring to a certain extent, the fixing ring cannot be smoothly conveyed into the blood vessel due to the fact that the size of the fixing ring is too large, a gap exists between the fixing ring and the inner wall of the blood vessel due to the fact that the size of the fixing ring is small, and a larger force needs to be applied to the outer wall of the blood vessel to enable the whole diameter of the blood vessel to shrink so that the inner wall of the blood vessel is attached to the fixing ring;
2. the diameter adjustable range of the super-elastic woven fixing ring is very large, the super-elastic woven fixing ring can be compressed to a smaller diameter during conveying, can actively adapt to the size of the inner wall of the blood vessel after being released, has good compliance with the inner wall of the blood vessel, is directly attached to the inner wall of the blood vessel, is not easy to generate gaps, and has good sealing property;
3. compared with other compressible designs, the novel blood pressure regulator uses a uniform, compact and vertically staggered grid structure, is uniformly stressed, and is not easy to generate fatigue fracture under the pulsating blood pressure in a human body;
4. when the mechanical locking piece is locked, the staggered grids can be compressed within a certain range, and weak links are not formed, so that the collapse and gaps at a certain position are caused, and blood leakage is not easy to occur;
5. the supporting force can be adjusted through the diameter of the wire material, the weaving density and angle and the number of the wire material, and vascular necrosis caused by over-pressing cannot occur;
6. after releasing, the height binding device can be locked, the diameter of the super-elastic woven fixing ring is controlled by controlling the height of the super-elastic woven fixing ring, and the excessive shrinkage of the diameter of the super-elastic woven fixing ring caused by excessive locking of a locking piece on the outer wall of a blood vessel is avoided.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.
FIG. 1 is a schematic structural diagram of a suture-free stent graft according to an embodiment of the present invention;
FIG. 2 is a schematic structural view of a suture-free stent artificial vascular band compression membrane sleeve provided by an embodiment of the invention;
fig. 3 is a schematic perspective view of a super-elastic knitted fixing ring according to an embodiment of the present invention;
FIG. 4 is a schematic plan view of a super-elastic knitted fastener ring according to an embodiment of the present invention;
fig. 5(a) - (c) are enlarged schematic views of the knitting structure of the superlastic knitted fixing ring provided in the embodiment of the invention.
In the figure: 1-artificial blood vessel body; 11-making vein artificial blood vessel; 12-non-striated portion artificial blood vessel; 2-a resilient metal support; 3-soft annular pocket; 4-ultra-elastic weaving the fixed ring; 5-compressing the membrane sleeve; 6-height restraint means; 7-anastomotic edge.
Detailed Description
The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; the connection can be mechanical connection or electrical connection; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.
Fig. 1 is a schematic structural view of a suture-free stent prosthesis provided in an embodiment of the present invention.
As shown in fig. 1, an embodiment of the present invention provides a suture-free stent prosthesis, including: the artificial blood vessel comprises an artificial blood vessel body 1, wherein the artificial blood vessel body 1 consists of a textured part artificial blood vessel 11 and a non-textured part artificial blood vessel 12 which are sequentially connected, and a compressible elastic metal stent 2 is sewed on the non-textured part artificial blood vessel 12; the thread-making part artificial blood vessel 11 is provided with a stitch-free connecting part which consists of a soft annular pocket 3 which is positioned on the outer side of the thread-making part artificial blood vessel 11 and is coaxially and seamlessly connected with the thread-making part artificial blood vessel 11 and a super-elastic weaving fixing ring 4 which is arranged between the soft annular pocket 3 and the thread-making part artificial blood vessel 11, and the super-elastic weaving fixing ring 4 is provided with a height restraining device 6 along the elastic direction; the super-elastic woven fixing ring 4 is of a grid structure which is staggered up and down and is woven by super-elastic nickel-titanium alloy wires.
Compared with the prior art, the suture-free stent artificial blood vessel has the following advantages:
in the suture-free stent prosthesis provided by the embodiment of the present invention, as shown in fig. 1, the suture-free stent prosthesis includes: the artificial blood vessel comprises an artificial blood vessel body 1, wherein the artificial blood vessel body 1 consists of a textured part artificial blood vessel 11 and a non-textured part artificial blood vessel 12 which are sequentially connected, and a compressible elastic metal stent 2 is sewed on the non-textured part artificial blood vessel 12; the thread-making part artificial blood vessel 11 is provided with a stitch-free connecting part which consists of a soft annular pocket 3 which is positioned on the outer side of the thread-making part artificial blood vessel 11 and is coaxially and seamlessly connected with the thread-making part artificial blood vessel 11 and a super-elastic weaving fixing ring 4 which is arranged between the soft annular pocket 3 and the thread-making part artificial blood vessel 11, and the super-elastic weaving fixing ring 4 is provided with a height restraining device 6 along the elastic direction; the super elastic braided fixing ring 4 is of a grid structure which is staggered up and down and is braided by super elastic nickel-titanium alloy wires. From the analysis, in the suture-free stent artificial blood vessel provided by the embodiment of the invention, because the proximal end of the artificial blood vessel is textured, the distal end of the artificial blood vessel is not textured, and the non-textured part is sutured with the elastic metal stent 2, the non-textured stent artificial blood vessel and the textured part artificial blood vessel 11 are integrally designed, a doctor does not need to inosculate the stent artificial blood vessel and the textured artificial blood vessel on an operation site, so that the operation steps are effectively simplified, and the probability of blood leakage of the aorta anastomosis is greatly reduced.
It should be noted that, in the suture-free stent prosthesis provided in the embodiment of the present invention, the superelastic woven fastener ring 4 has the characteristics of reduced diameter and increased length after compression, so that the length of the soft annular pocket 3 is slightly longer than the length of the superelastic woven fastener ring 4.
Moreover, as shown in fig. 1, the height restriction device 6 may be a silk thread, the silk thread penetrates through the soft annular pocket 3 and then penetrates through the terminal network of the super-elastic braided fixing ring 4, after the release is completed, a doctor ties the two ends of the silk thread, so that the terminal of the super-elastic braided fixing ring 4 and the middle position of the soft annular pocket 3 can be fixed together, the height of the super-elastic braided fixing ring 4 is locked, and the over-compression can be well avoided. A plurality of height-restricting devices 6, such as wire structures, may be distributed in the circumferential direction of the superelastic braided fixing ring 4 as needed. When the height restraint device 6 is a silk thread, the silk thread can also directly penetrate through the far end and the near end of the super-elastic braided fixing ring 4 and be fixed through knotting or other reasonable modes.
In addition, in the sewing-free stent prosthesis provided by the embodiment of the invention, the compressible elastic metal stent 2 is sewn on the proximal end of the prosthesis, the distal end of the prosthesis is not provided with the veins, and the part without the veins is sewn, so that the probability of blood leakage of the descending aorta anastomosis opening can be effectively reduced due to the integrated design. The outer side of the artificial blood vessel pattern-making part is provided with a soft annular pocket 3 without blood leakage, and the soft annular pocket can be tightly attached and connected with the broken end of the autologous blood vessel of the descending aorta through a mechanical locking part to prevent blood leakage; the anastomotic stoma is positioned at the outer side of the artificial blood vessel and cannot be directly impacted by the blood flow and the pressure difference of the active artery, the area of mechanical locking is far larger than the continuous anastomotic area, the pressure on the blood vessel is more average, the probability of blood leakage due to blood vessel tearing is greatly reduced, the mechanical locking piece improves the anastomotic speed, the aorta blocking and circulation stopping time is shortened, the incidence and the death rate of central nervous system complications can be effectively reduced, the operation difficulty is reduced, the operation is simple and easy to master, the operation is facilitated, more patients benefit, and the incidence rate of the related complications of anastomotic stoma bleeding is effectively reduced.
Fig. 2 is a schematic structural view of a suture-free stent prosthesis vascular band compression membrane sleeve provided by an embodiment of the present invention.
In practical application, as shown in fig. 2, a compression film sleeve 5 may be disposed at the outer side of the seam-free connection portion, corresponding to the elastic metal stent 2 and adjacent to the superelastic woven fixing ring 4; specifically, a fan-shaped compression film sleeve or a straight compression film sleeve is arranged at the outer side of the artificial blood vessel 12 at the non-textured part and corresponding to the elastic metal stent 2. The super-elastic braided fixing ring 4 is already packaged in the soft annular bag 3, the soft annular bag 3 is integrated with the artificial blood vessel 12 of the non-textured part, and the compression membrane sleeve 5 is additionally arranged; wherein, the compression membrane sleeve 5 can compress the diameters of the elastic metal stent 2 and the super-elastic woven fixing ring 4 and then send the compressed diameters into the autologous blood vessel without damaging the intima of the blood vessel. In addition, the central line of the compression membrane sleeve 5 is connected with the artificial blood vessel of the stent, and the edges of the two sides of the membrane sleeve are provided with hole slots, so that the release wire can alternately pass through the hole slots at the edge of the membrane sleeve and is used for restraining the stent well.
Fig. 3 is a schematic perspective view of a super-elastic knitted fixing ring according to an embodiment of the present invention; FIG. 4 is a schematic plan view of a super-elastic knitted fastener ring according to an embodiment of the present invention; fig. 5(a) - (c) are enlarged schematic views of the knitting structure of the superlastic knitted fixing ring provided in the embodiment of the invention.
As shown in fig. 3 and 4, the diameter of the super-elastic braided fixing ring 4 is slightly larger than the diameter of the artificial blood vessel 11 of the textured part, and the interference can be 10% -40%; specifically, the superelastic braided fixing ring 4 can be braided from a superelastic nitinol wire, and the wire can be circular or rectangular in cross-section, and the diameter can be 0.30mm to 0.40mm when the cross-section is circular; furthermore, the super-elastic woven fixing ring 4 can be of a grid structure which is staggered up and down, the grid structure can be a rhombic grid, and the width and the height of the rhombic grid can be 2mm-5mm respectively; further, the superelastic braided fixing ring 4 may be braided from superelastic nitinol wires, and the number of braided wires may be 1-4, and the specific braiding method may be one-over-one-under or two-over-two-under, as shown in fig. 5(a) - (c). In addition, the knitting method can also be continuous knitting, and the knitting method can be wound back when the knitting reaches the tail end.
The super-elastic braided fixing ring 4 in the suture-free stent prosthesis blood vessel provided by the embodiment of the invention is formed by braiding super-elastic nickel-titanium alloy wires, the outer diameter of the fixing ring can be compressed by a conveyor, so that the conveying process is simpler, and the condition that the existing fixing ring cannot be conveyed in place due to large diameter and small inner diameter of the blood vessel can be avoided; after the fixing ring is conveyed in place, the super-elastic braided fixing ring 4 can be released through a conveyor, the super-elastic braided fixing ring 4 can be automatically expanded and attached to the inner wall of a blood vessel, and the situations that the fixing ring is too large in size and difficult to convey and too small in size and a gap is formed between the fixing ring and the inner wall of the blood vessel cannot occur; the diameter can be automatically rebounded to the original diameter after being compressed, and the implantation process is simpler; the super-elastic braided fixing ring 4 is a dense grid braided by wires, has good adhesion with blood vessels, and is not easy to collapse and bleed in the ribbon compression process; the super-elastic braided fixing ring 4 is made of super-elastic nickel-titanium alloy wires, has higher anti-extrusion capacity and lower supporting force in the process of blood vessel pulsation, prevents blood leakage and can reduce the damage to the blood vessel; the diameter of the super-elastic braided fixing ring 4 can be prevented from being excessively compressed by a mechanical locking piece; the gaps of the grids can play a role in preventing slipping and avoiding necrosis of blood vessels; the anastomotic flange 7 can provide a displacement and leakage mending effect, providing a double layer of safety assurance.
In practical application, in order to better deliver the suture-free stent prosthesis into the autologous blood vessel, in the suture-free stent prosthesis provided by the embodiment of the present invention, the non-textured portion prosthesis 12 may have a straight-tube or tapered structure; the artificial blood vessel 11 may have a branched artificial blood vessel.
The embodiment of the invention also provides a super-elastic braided fixing ring, wherein a height restraining device 6 is arranged on the super-elastic braided fixing ring 4 along the elastic direction; the super-elastic weaving fixing ring 4 is of a grid structure which is staggered up and down, and the grid structure is a rhombic grid; the superelastic braided fixing ring 4 is braided by superelastic nickel-titanium alloy wires, and the cross section of each wire is circular or rectangular.
Compared with the prior art, the super-elastic woven fixing ring provided by the embodiment of the invention has the following advantages:
1. the super-elastic woven fixing ring has the advantages of being matched with the diameter of a blood vessel, the fixing ring with the non-adjustable diameter needs to obtain a good sealing effect, the diameter of the blood vessel needs to be matched with the diameter of the fixing ring to a certain extent, the fixing ring cannot be smoothly conveyed into the blood vessel due to the fact that the size of the fixing ring is too large, a gap exists between the fixing ring and the inner wall of the blood vessel due to the fact that the size of the fixing ring is small, and a larger force needs to be applied to the outer wall of the blood vessel to enable the whole diameter of the blood vessel to shrink so that the inner wall of the blood vessel is attached to the fixing ring;
2. the diameter adjustable range of the super-elastic woven fixing ring is very large, the super-elastic woven fixing ring can be compressed to a smaller diameter during conveying, can actively adapt to the size of the inner wall of the blood vessel after being released, has good compliance with the inner wall of the blood vessel, is directly attached to the inner wall of the blood vessel, is not easy to generate gaps, and has good sealing property;
3. compared with other compressible designs, the novel blood pressure regulator uses a uniform, compact and vertically staggered grid structure, is uniformly stressed, and is not easy to generate fatigue fracture under the pulsating blood pressure in a human body;
4. when the mechanical locking piece is locked, the staggered grids can be compressed within a certain range, and weak links are not formed, so that the collapse and gaps at a certain position are caused, and blood leakage is not easy to occur;
5. the supporting force can be adjusted through the diameter of the wire material, the weaving density and angle and the number of the wire material, and vascular necrosis caused by over-pressing cannot occur;
6. after releasing, the height binding device can be locked, the diameter of the super-elastic woven fixing ring is controlled by controlling the height of the super-elastic woven fixing ring, and the excessive shrinkage of the diameter of the super-elastic woven fixing ring caused by excessive locking of a locking piece on the outer wall of a blood vessel is avoided.
It should be added that the anastomosis of the distal anastomosis of the descending aorta of the prior art requires 20-30 needles for anastomosis, the surgeon needs to operate in a narrow space using a needle holder, each needle needs to penetrate the autologous blood vessel, the artificial blood vessel and the covered stent, and the most skilled doctor needs 20 minutes even though the most time-saving continuous anastomosis method is used. The diseased blood vessels are very fragile, the control on the anastomosis distance and the force is not good, the blood of the aorta directly impacts the anastomosis joint, the anastomosis joint is very likely to be torn and bleed, once the bleeding needs to take longer time to repair, the descending aorta anastomosis process is in a state of systemic circulatory arrest, although the head is perfused by the brain, the complications of visceral ischemia and spinal ischemia still occur when the lower limb circulatory arrest time is too long, doctors need to reduce the body temperature of patients to about 15 ℃ through extracorporeal circulation in advance, and the time for cooling and rewarming is at least 3 hours.
By using the suturing-free stent artificial blood vessel and the super-elastic woven fixing ring provided by the embodiment of the invention, a doctor does not need to have a long learning curve to master, the anastomosis time of the descending aorta anastomosis stoma can be reduced to 5 minutes, the body temperature of a patient only needs to be reduced to 20-25 ℃, and the time for cooling and rewarming can be reduced to 1.5 hours. The anastomotic orifice is positioned on the outer side of the artificial blood vessel and cannot be directly impacted by the blood flow and the pressure difference of the active artery, the area of the mechanical locking piece is far larger than the area of continuous anastomosis, the pressure on the blood vessel is more average, and the probability of blood leakage caused by blood vessel tearing is greatly reduced.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.
Claims (9)
1. A suture-free stent prosthesis, comprising: the artificial blood vessel comprises an artificial blood vessel body, a blood vessel core and a blood vessel core, wherein the artificial blood vessel body consists of a textured part artificial blood vessel and a non-textured part artificial blood vessel which are sequentially connected, and a compressible elastic metal support is sewed on the non-textured part artificial blood vessel;
the thread-making part artificial blood vessel is provided with a stitch-free connecting part, the stitch-free connecting part consists of a soft annular pocket which is positioned on the outer side of the thread-making part artificial blood vessel and is coaxially and seamlessly connected with the thread-making part artificial blood vessel, and a super-elastic weaving fixing ring which is placed between the soft annular pocket and the thread-making part artificial blood vessel, and a height restraining device is arranged on the super-elastic weaving fixing ring along the elastic direction; the super-elastic braided fixing ring is of a grid structure which is staggered up and down and is braided by super-elastic nickel-titanium alloy wires;
the height restraint device adopts the silk thread, the silk thread passes soft annular pocket with solid fixed ring's terminal net is woven to super bullet for after the release is accomplished, with the mode of knoing at both ends will solid fixed ring's end is woven to super bullet with the intermediate position of soft annular pocket is fixed together, and then locks solid fixed ring's height is woven to super bullet.
2. The suture-free stent prosthesis according to claim 1, wherein a compression sleeve is disposed outside the suture-free connection portion and adjacent to the superelastic woven fixation ring corresponding to the elastic metal stent.
3. The suture-free stent prosthesis according to claim 1 or 2, wherein the diameter of the super-elastic braided fixing ring is slightly larger than that of the textured portion prosthesis, and the interference is 10-40%.
4. The suture-free stent prosthesis according to claim 1 or 2, wherein the superelastic braided fixing ring is braided from superelastic nitinol wires, and the wires are circular in cross-section.
5. The suture-free stent prosthesis according to claim 1 or 2, wherein the superelastic braided fixing ring is braided from superelastic nitinol wires, and the wires have a rectangular cross-section.
6. The suture-free stent prosthesis according to claim 1 or 2, wherein the super-elastic woven fixing ring is of a mesh structure which is staggered up and down, the mesh structure is a rhombic mesh, and the width and the height of the rhombic mesh are respectively 2mm-5 mm.
7. The suture-free stent prosthesis according to claim 1 or 2, wherein the superelastic braided fixing ring is braided from superelastic nitinol wires, and the number of braided wires is 1-4, the braiding method being one-over-one or two-over-two-under.
8. The suture-free stent graft of claim 1, wherein the non-textured portion graft is a straight tubular or conical structure.
9. The suture-free stent graft of claim 1 or 8, wherein the textured portion graft has a branch graft.
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| CN109223250B (en) * | 2018-10-12 | 2020-12-29 | 大连科万维医疗科技有限公司 | Suture-free integrated branch covered stent blood vessel |
| WO2020181430A1 (en) * | 2019-03-08 | 2020-09-17 | 孟国伟 | Artificial blood vessel |
| CN111358593A (en) * | 2020-03-19 | 2020-07-03 | 江苏百优达生命科技有限公司 | Quick-connection type thoracotomy vascular stent and conveying system |
| CN113413255B (en) * | 2021-08-24 | 2021-11-16 | 南通欣昌减震器有限公司 | Blood vessel supporting rubber stent |
| CN116942384B (en) * | 2023-09-19 | 2023-12-05 | 北京华脉泰科医疗器械股份有限公司 | Suture-free multi-branch artificial blood vessel covered stent |
| CN117357305B (en) * | 2023-12-08 | 2024-03-19 | 北京华脉泰科医疗器械股份有限公司 | Artificial blood vessel fixing device |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US20030097170A1 (en) * | 2001-09-25 | 2003-05-22 | Curative Ag | Implantation device for an aorta in an aortic arch |
| CN201642417U (en) * | 2009-12-23 | 2010-11-24 | 孙立忠 | Artificial blood vessel coated stand combined body |
| US9326870B2 (en) * | 2010-04-23 | 2016-05-03 | Medtronic Vascular, Inc. | Biodegradable stent having non-biodegradable end portions and mechanisms for increased stent hoop strength |
| CN106726001B (en) * | 2017-01-06 | 2019-01-25 | 北京华脉泰科医疗器械有限公司 | Exempt to suture stent-graft and its conveying device, identical retaining ring |
| CN106726002B (en) * | 2017-01-06 | 2018-10-12 | 北京华脉泰科医疗器械有限公司 | Exempt to suture blood vessel graft, support lantern ring |
| CN208838245U (en) * | 2017-11-22 | 2019-05-10 | 北京华脉泰科医疗器械有限公司 | Exempt to suture stent-graft, superlastic braiding fixed ring |
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