A vascular suture-free device, a suture-free artificial blood vessel, and a delivery system

Abstract

The present invention relates to the field of medical device technology, and in particular to a suture-free blood vessel device, a suture-free artificial blood vessel, and a delivery system. The suture-free blood vessel device comprises a hoop and a skirt, one end of the skirt is fixedly mounted on the hoop, and a side edge of the skirt is provided with an incision for cutting the skirt along its axial direction, and a binding wire is provided at the incision for pulling the incision together and tightening it. The beneficial effect of the present invention is as follows: during surgery, a vascular blocking forceps is used to clamp the hoop, and the hoop and the skirt are inserted along the stump of the descending aorta and then sleeved on the outside of the descending aorta. Then, a stent graft is implanted into the inner wall of the descending aorta, and the binding wire is tightened. The stent graft and the skirt clamp the inside and outside of the descending aorta to achieve a suture-free effect, so that the descending aorta, the stent graft, and the artificial blood vessel can be quickly and tightly connected together, thereby greatly shortening the deep hypothermic circulatory arrest time during surgery and reducing surgical complications.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a suture-free blood vessel device, a suture-free artificial blood vessel and a delivery system. Background Art

[0002] In the 1970s, foreign scholars developed a cannula ring-type suture-free artificial blood vessel and conducted a small number of attempts. The idea is to use a hard tubular material such as glass or metal to make an artificial blood vessel with a cannula ring at the end of the artificial blood vessel. During anastomosis, the cannula is placed into the human blood vessel and then ligated outside the vascular cavity without suturing. The anastomosis of the distal and proximal aorta is completed in a very short time, which greatly speeds up the anastomosis speed, significantly shortens the amount of bleeding and circulatory arrest time, and thus avoids damage to the nervous system.

[0003] In the 1980s, Lemole et al. used sutureless aortic grafts in 31 patients with abdominal aortic aneurysms, achieving an average aortic occlusion time of only 17 minutes and no major complications. Oz et al. performed 49 surgeries using this type of graft, achieving a operative mortality rate of 4% (for aneurysms) and 18% (for aortic dissection), with a 5-year survival rate of 64%. This study was subsequently expanded to 123 cases, demonstrating excellent results with no complications such as anastomotic bleeding, thrombosis, or pseudoaneurysms. Liu and Spagna et al. also demonstrated the reliable anastomotic performance of sutureless grafts, with low mortality and complication rates using this method.

[0004] Relevant experimental research has been conducted in China using homemade suture-free artificial blood vessels. The results have shown that suture-free artificial blood vessels can maintain vascular function satisfactorily and have good biocompatibility. The use of suture-free artificial blood vessels can greatly simplify surgical operations, significantly shorten operation time, and has great clinical value.

[0005] Currently, most of them are in the experimental research stage. The main structure of the reported suture-free artificial blood vessels is: a hard ring is used as the inner ring, which is placed inside the artificial blood vessel / human blood vessel, and a clamp, suture, ligature, etc. are used as a suture-free structure on the outside of the artificial blood vessel / human blood vessel to ligate the artificial blood vessel / human blood vessel to the inner ring, thereby achieving suture-free connection between artificial blood vessels / human blood vessels.

[0006] The existing suture-free structure is difficult to operate and install during surgery, which affects the operation time. The patient is in deep hypothermia or medium-low temperature extracorporeal circulation for a long time, which increases the risk of surgery. Summary of the Invention

[0007] The technical problem to be solved by the present invention is to provide a vascular suture-free device, a suture-free artificial blood vessel and a delivery system, so that the descending aorta, the covered stent and the artificial blood vessel can be quickly and tightly connected together, thereby greatly shortening the deep hypothermic circulatory arrest time during the operation and reducing surgical complications.

[0008] The technical solution of the present invention to solve the above-mentioned technical problems is as follows: a vascular suture-free device, comprising a hoop and a skirt, one end of the skirt being fixed on the hoop, a side edge of the skirt being provided with an incision for cutting the skirt along its axial direction, and a binding wire being provided at the incision for pulling the incision together and tightening it.

[0009] The beneficial effects of the present invention are as follows: during the operation, a vascular blocking forceps is used to clamp the hoop, the hoop and the skirt are inserted along the broken end of the descending aorta and then put on the outside of the descending aorta, and then the covered stent is implanted into the inner wall of the descending aorta, the binding line is tightened, and the covered stent and the skirt clamp the inside and outside of the descending aorta to achieve a suture-free effect, so that the descending aorta, the covered stent and the artificial blood vessel can be quickly and tightly connected together, thereby greatly shortening the deep hypothermic circulatory arrest time during the operation and reducing surgical complications.

[0010] On the basis of the above technical solution, the present invention can also be improved as follows.

[0011] Furthermore, one end of the skirt is fixed to the inner side or outer side of the hoop by sewing or bonding.

[0012] The beneficial effect of adopting the above further solution is: one end of the skirt is fixed to the inner side of the hoop by suturing or bonding, and the skirt is pressed against the outer wall of the blood vessel through the hoop to ensure the stability of the skirt fixation.

[0013] Furthermore, the incision divides the skirt into two gathered edges along the axial direction, and each of the gathered edges is provided with multiple perforations, which are evenly arranged along the length direction of the gathered edges, and the two ends of the binding wire respectively pass through and extend out of the perforations on the two gathered edges.

[0014] The beneficial effect of adopting the above further scheme is: by pre-setting the perforations, and then passing the two ends of the binding wire through the perforations respectively, the two gathering edges are gathered in a manner similar to tying shoelaces, thereby adjusting the inner diameter of the skirt, and cooperating with the coated stent to achieve internal and external clamping of the descending aorta.

[0015] Furthermore, the skirt is made of PTFE, PET or polyethylene.

[0016] The beneficial effects of adopting the above further solution are: easy production, non-toxic and harmless, ensuring safety after implantation into the human body.

[0017] The present invention solves the above technical problems and also provides a suture-free artificial blood vessel, comprising an artificial blood vessel body, a coated stent and the blood vessel suture-free device as described above, one end of the artificial blood vessel body is fixedly connected to one end of the coated stent, and the hoop and the skirt are mounted on the coated stent.

[0018] The beneficial effects of adopting the above scheme are: the artificial blood vessel body is fixedly connected to the coated stent, and a suture-free connection with the human blood vessel is achieved through a vascular suture-free device mounted on the coated stent, which greatly shortens the deep hypothermic circulatory arrest time during the operation and reduces surgical complications.

[0019] Furthermore, the stent graft comprises a straight-cylindrical stent graft integrally fixedly connected to the artificial blood vessel body and an elastic stent disposed on the straight-cylindrical stent graft, and the hoop and the skirt are sleeved on the straight-cylindrical stent graft.

[0020] The beneficial effect of adopting the above further scheme is that the coated stent includes a straight cylindrical coating and an elastic bracket. The straight cylindrical coating is convenient for fixed connection with the artificial blood vessel body, and the setting of the elastic bracket can facilitate cooperation with the suture-free device to achieve internal and external clamping of the descending aorta, thereby achieving a suture-free effect.

[0021] The present invention solves the above technical problems and also provides a suture-free artificial blood vessel delivery system, comprising a handle and a flexible sheath, the front of the handle being fixedly connected to one end of a support part, the upper surface of the support part being provided with a placement groove, the end of the support part away from the handle being fixedly connected to an arc-shaped lower cover with an arc-shaped groove on the upper surface, the arc-shaped lower cover being hingedly provided with an arc-shaped upper cover with an arc-shaped groove on the lower surface, the arc-shaped upper cover and the arc-shaped lower cover being bound together by a first silk thread; one end of the sheath tube is clamped between the arc-shaped upper cover and the arc-shaped lower cover, the handle being provided with a bracket release pull ring, the bracket release pull ring being respectively connected to the two sides of the sheath tube by two pull straps; a cutting knife is fixedly provided on the inner side of the arc-shaped upper cover and the arc-shaped lower cover, the blade of the cutting knife facing away from the support part is used for cutting the sheath tube when the sheath tube is pulled toward the handle; a handle pull ring is provided in the handle, and the handle pull ring is connected to the first silk thread and the second silk thread for binding the blood vessel through a connecting line.

[0022] The beneficial effects of adopting the above scheme are: first, the suture-free blood vessel device is placed on the outer wall of the human blood vessel, the suture-free artificial blood vessel is placed in the sheath placement groove, and the coated stent is placed in the sheath at the same time. The sheath is bent into an arc that matches the human blood vessel, the sheath is inserted into the human blood vessel, and then the stent release pull ring is pulled to move the sheath outward. Under the action of the cutting knife, the sheath is cut, thereby releasing the coated stent, so that the coated stent is stretched to abut the inner wall of the human blood vessel, and under the internal and external clamping of the hoop, skirt and coated stent, a suture-free connection between the artificial blood vessel and the human blood vessel is achieved.

[0023] Furthermore, it also includes a tip for being arranged at one end of the sheath away from the support part, a bendable connecting rod is provided in the placement groove, one end of the connecting rod is fixedly connected to the support part, and the other end of the connecting rod is fixedly connected to the tip.

[0024] The beneficial effect of adopting the above further solution is that the sheath is easily inserted into the human blood vessel by providing the tip. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 This is a schematic structural diagram of a vascular suture-free device according to the present invention;

[0026] Figure 2 This is a schematic structural diagram of a suture-free artificial blood vessel of the present invention;

[0027] Figure 3 This is a front view of a delivery system for a suture-free artificial blood vessel according to the present invention;

[0028] Figure 4 A top view of a delivery system for a suture-free artificial blood vessel according to the present invention;

[0029] In the accompanying drawings, the components represented by the reference numerals are as follows:

[0030] 1. Hoop; 2. Skirt; 3. Incision; 4. Binding line; 5. Gathered edge; 6. Perforation; 7. Artificial blood vessel body; 8. Straight cylindrical coating; 9. Elastic bracket; 10. Connecting rod; 11. Handle; 12. Sheath; 13. Support part; 14. Placement slot; 15. Arc-shaped lower cover; 16. Arc-shaped upper cover; 17. First silk thread; 18. Bracket release pull ring; 19. Pull belt; 20. Cutting knife; 21. Handle pull ring; 22. Tip. DETAILED DESCRIPTION

[0031] The principles and features of the present invention are described below with reference to the accompanying drawings. The examples given are only used to explain the present invention and are not used to limit the scope of the present invention.

[0032] Example 1

[0033] like Figure 1 As shown, this embodiment discloses a vascular suture-free device, including a hoop 1 and a skirt 2, one end of the skirt 2 is fixed on the hoop 1, specifically, one end of the skirt 2 is fixed on the inner side of the hoop 1 by sewing or bonding, and one end of the skirt 2 is fixed to the inner side of the hoop 1 by sewing or bonding, and the skirt 2 is pressed against the outer wall of the blood vessel by the hoop 1 to ensure the stability of the skirt 2. Since the vascular suture-free device needs to be implanted in the human body, when the skirt 2 and the hoop 1 are fixed by bonding, it is necessary to use a safe adhesive that will not cause harm to the human body. The specific adhesive selection is the existing technology in this field and is not specifically listed here. The side of the skirt 2 is provided with an incision 3 for cutting the skirt 2 along its axial direction, and the incision 3 is provided with a binding wire 4 for pulling the incision 3 together and tightening it.

[0034] The incision 3 cuts the skirt 2 in the axial direction, and then the two sides of the incision 3 are pulled together and tightened by the binding wire 4 to adjust the inner diameter of the skirt 2 as needed. During the operation, a vascular blocking forceps is used to clamp the hoop 1, and the hoop 1 and the skirt 2 are inserted along the broken end of the descending aorta and then put on the outside of the descending aorta. The covered stent is then implanted into the inner wall of the descending aorta, and the binding wire 4 is tightened. The covered stent and the skirt 2 clamp the inside and outside of the descending aorta to achieve a suture-free effect, so that the descending aorta, the covered stent and the artificial blood vessel can be quickly and tightly connected together, thereby greatly shortening the deep hypothermia circulatory arrest time during the operation and reducing surgical complications.

[0035] Preferably, the incision 3 divides the skirt 2 into two gathering edges 5 along the axial direction, and each of the gathering edges 5 is provided with a plurality of perforations 6, and the plurality of perforations 6 are evenly arranged along the length direction of the gathering edges 5. The two ends of the binding wire 4 respectively pass through and extend out of the perforations 6 on the two gathering edges 5. In order to avoid the perforations 6 being pulled through under the action of the tension of the binding wire 4, the perforations 6 are at a certain distance from the gathering edges. According to the outer diameter of the human blood vessel to be connected to the artificial blood vessel, multiple rows of perforations 6 can be provided on the side of each gathering edge. The binding wire 4 can be adjusted to penetrate different perforations 6 according to the outer diameter of the human blood vessel to ensure that pressure can be applied to the human blood vessel from the outer wall of the human blood vessel. At the same time, the connecting line of the multiple perforations 6 on each gathering edge can be extended along the length direction of the gathering edge, or can be inclined to the length direction of the gathering edge. By pre-setting the perforation 6, and then passing the two ends of the binding wire 4 through the perforation 6 respectively, the two gathering edges 5 are gathered in a manner similar to tying shoelaces, thereby adjusting the inner diameter of the skirt 2, thereby cooperating with the coated stent to achieve internal and external clamping of the descending aorta.

[0036] In this embodiment, the skirt 2 is made of PTFE, PET or polyethylene, which is easy to manufacture and non-toxic and harmless, ensuring safety after implantation into the human body.

[0037] Example 2

[0038] like Figure 2 As shown, this embodiment discloses a suture-free artificial blood vessel, including an artificial blood vessel body 7, a coated stent and a blood vessel suture-free device as described above, one end of the artificial blood vessel body 7 is fixedly connected to one end of the coated stent, and the hoop 1 and the skirt 2 are mounted on the coated stent.

[0039] In this embodiment, the stent graft includes a straight-cylindrical graft 8 integrally fixedly connected to the artificial blood vessel body 7 and an elastic support 9 disposed on the straight-cylindrical graft 8. The hoop 1 and the skirt 2 are sleeved on the straight-cylindrical graft 8. The stent graft includes the straight-cylindrical graft 8 and the elastic support 9. The straight-cylindrical graft 8 facilitates fixed connection to the artificial blood vessel body 7. The provision of the elastic support 9 facilitates cooperation with the suture-free device to achieve internal and external clamping of the descending aorta, achieving a suture-free effect.

[0040] Example 3

[0041] like Figure 3 、 Figure 4 As shown, this embodiment discloses a delivery system for a suture-free artificial blood vessel, comprising a handle 11 and a flexible sheath 12, wherein the front portion of the handle 11 is fixedly connected to one end of a support portion 13, the upper surface of the support portion 13 is provided with a placement groove 14, the end of the support portion 13 away from the handle 11 is fixedly connected to an arc-shaped lower cover 15 with an arc-shaped groove on the upper surface, the arc-shaped lower cover 15 is hinged with an arc-shaped upper cover 16 with an arc-shaped groove on the lower surface, the arc-shaped upper cover 16 and the arc-shaped lower cover 15 are bound by a first silk thread 17; one end of the sheath 12 is clamped between the arc-shaped upper cover 16 and the arc-shaped lower cover 15 Between the arc-shaped lower cover 15, a bracket release pull ring 18 is provided on the handle 11, and the bracket release pull ring 18 is respectively connected to the two sides of the sheath 12 through two pull straps 19; a cutting knife 20 is fixed on the inner side of the arc-shaped upper cover and the arc-shaped lower cover 15, and the blade of the cutting knife 20 is facing away from the support part 13 and is used to cut the sheath 12 when the sheath 12 is pulled toward the handle 11; a handle pull ring 21 is provided in the handle 11, and the handle pull ring 21 is connected to the first silk thread 17 and the second silk thread for binding the blood vessel through a connecting line.

[0042] Preferably, it also includes a tip 22 for being arranged at one end of the sheath 12 away from the support portion 13, a bendable connecting rod 10 is provided in the placement groove 14, one end of the connecting rod 10 is fixedly connected to the support portion 13, and the other end of the connecting rod 10 is fixedly connected to the tip 22. By providing the tip 22, the sheath 12 is conveniently inserted into the human blood vessel. In order to facilitate the connection between the tip 22 and the connecting rod 10, the end of the connecting rod 10 is provided with an external thread, and a thread groove is provided on the tail end of the tip 22. The connecting rod 10 is threadedly connected to the tip 22, and installation and disassembly are convenient.

[0043] In this embodiment, a pre-cut 3 corresponding to the two cutting knives 20 is provided on one end of the sheath tube 12 connecting the support part 13, the blades of the two cutting knives 20 are arranged corresponding to the two pre-cuts 3, and the two drawstrings 19 are respectively connected to the sheath tube 12 on both sides of the two pre-cuts 3.

[0044] Working principle: 1. Use a vascular blocking forceps to clamp the hoop 1, insert the hoop 1 and the skirt 2 along the stump of the descending aorta and then put them on the outside of the descending aorta. The proximal end of the skirt 2 (i.e. the end connected to the hoop 1) should be flush with the stump of the descending aorta; 2. Pre-place the artificial blood vessel to be covered in the sheath 12. Specifically, place the artificial blood vessel body 7 in the placement groove 14, and place the covered stent in the sheath 12. At the same time, pass the connecting rod 10 through and extend it out of the artificial blood vessel body 7 and the inner side of the covered stent, and then connect it to the tip 22 set at the end of the sheath 12. Connect the connecting line with the first silk thread 17 and the second silk thread. The first silk thread 17 and the second silk thread are tied with a slipknot (the specific tying method is a conventional technology in this field and will not be described in detail here); 3. Bend the sheath 12 The stent is implanted into the human blood vessel through the tip 22 after the curvature is adjusted to match that of the human blood vessel; 4. Pull the stent release ring to make the sheath 12 withdraw from the human blood vessel and be cut by the cutting knife 20 while withdrawing. Since the inner sides of the arc-shaped upper cover 16 and the arc-shaped lower cover 15 are provided with cutting knives 20, the sheath 12 is divided into two semi-cylinders after being cut. After the sheath 12 is cut, under the elastic action of the elastic support 9, the stent is ejected from the cut sheath 12 and supported on the inner wall of the human blood vessel; 5. After releasing the stent, pull the handle pull ring 21 to loosen the first thread 17 that binds the arc-shaped upper cover 16 and the arc-shaped lower cover 15 and the second thread that binds the blood vessel at the same time; 6. Then pull out the handle 11 and the support part 13, and at the same time bring out the tip 22 to complete the delivery of the artificial blood vessel during the operation.

[0045] First, the suture-free device is placed on the outer wall of the human blood vessel, the suture-free artificial blood vessel is placed in the sheath 12 placement groove 14, and the coated stent is placed in the sheath 12 at the same time. The sheath 12 is bent into an arc that matches the human blood vessel, and the sheath 12 is inserted into the human blood vessel. Then, the stent release pull ring 18 is pulled to move the sheath 12 outward. Under the action of the cutting knife 20, the sheath 12 is cut, thereby releasing the coated stent, so that the coated stent is stretched to abut the inner wall of the human blood vessel. Under the internal and external clamping of the hoop 1 and the skirt 2 and the coated stent, the suture-free connection between the artificial blood vessel and the human blood vessel is achieved.

[0046] In the description of the present invention, it should be understood that the terms "center", "length", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "inside", "outside", "peripheral", "circumferential" and the like to indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred system or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0047] In the description of the present invention, “a plurality of” means at least two, for example, two, three, etc., unless otherwise clearly and specifically defined.

[0048] In the present invention, unless otherwise specified or limited, the terms "installed," "connected," "connect," "fixed," etc. should be understood in a broad sense. For example, they can refer to fixed connection, detachable connection, or integration; mechanical connection, electrical connection; direct connection, or indirect connection through an intermediate medium; internal communication between two components, or interaction between two components, unless otherwise specified. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0049] In the description of this specification, the reference terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" mean that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art can combine and combine different embodiments or examples described in this specification and features of different embodiments or examples without contradiction.

[0050] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A suture-free artificial blood vessel delivery system, characterized in that: The invention comprises a handle (11) and a bendable sheath tube (12), wherein the front portion of the handle (11) is fixedly connected to one end of a support portion (13), the upper surface of the support portion (13) is provided with a placement groove (14), the end of the support portion (13) away from the handle (11) is fixedly connected to an arc-shaped lower cover (15) with an arc-shaped groove on the upper surface, the arc-shaped lower cover (15) is hingedly connected to an arc-shaped upper cover (16) with an arc-shaped groove on the lower surface, and the arc-shaped upper cover (16) and the arc-shaped lower cover (15) are bound together by a first silk thread (17); one end of the sheath tube (12) is clamped between the arc-shaped upper cover (16) and the arc-shaped lower cover (15), and the handle A stent release pull ring (18) is provided on the handle (11), and the stent release pull ring (18) is respectively connected to the two sides of the sheath tube (12) through two pull belts (19); a cutting knife (20) is fixed on the inner side of the arc-shaped upper cover and the arc-shaped lower cover (15), and the blade of the cutting knife (20) faces away from the support part (13) and is used to cut the sheath tube (12) when the sheath tube (12) is pulled toward the handle (11); a handle pull ring (21) is provided in the handle (11), and the handle pull ring (21) is connected to the first silk thread (17) and the second silk thread for binding and fixing the artificial blood vessel through a connecting line.

2. A suture-free artificial blood vessel delivery system according to claim 1, characterized in that: It also includes a tip (22) for being arranged at one end of the sheath tube (12) away from the support portion (13), a bendable connecting rod (10) is provided in the placement groove (14), one end of the connecting rod (10) is fixedly connected to the support portion (13), and the other end of the connecting rod (10) is fixedly connected to the tip (22).

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