Stent graft fixation release device and stent graft delivery system

Abstract

The present invention provides a stent graft fixing and releasing device and a stent graft delivery system, which relate to the field of medical devices. The present invention includes a guide seat, a fixer, a locking structure, and a tie rod made of a flexible material; the guide seat is provided with a first mounting through hole axially penetrating the guide seat, and the fixer is provided with a second mounting through hole axially penetrating the fixer; there are a plurality of tie rods, one end of each of the plurality of tie rods is fixed to the fixer, and the plurality of tie rods are spaced in pairs around the radial circumferential surface of the fixer, and the other ends of each of the plurality of tie rods are fixed to the guide seat by the locking structure, and when the fixer moves in a direction away from the guide seat, the tie rod can be detached from the locking structure. The present invention alleviates the technical problems that the existing stent graft fixing and releasing device is very easy to scratch the blood vessel in a narrow and curved blood vessel channel, causing blood vessel damage or even rupture, which will cause fatal damage to the patient if not handled with care, thereby leading to high surgical difficulty and low surgical success rate.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a stent graft fixing and releasing device and a stent graft conveying system. Background Art

[0002] Aortic diseases include aortic dissection and aortic aneurysm, which are mainly caused by hypertension, arteriosclerosis, injury, infection and other reasons. It is a cardiovascular disease that seriously threatens human health and patients face great life threats. The traditional surgical method for treating aortic diseases is to introduce extracorporeal circulation, perform open surgery, and replace artificial blood vessels at the damaged site, but open surgery takes a long time, causes great surgical trauma, and has a very high mortality rate. In recent years, it has become popular to use minimally invasive interventional methods to treat patients, namely: through a unique delivery system, the covered stent is released to the patient's vascular lesion site, and the aortic dissection and aortic aneurysm blood vessels are repaired to protect the diseased blood vessels and avoid rupture of the diseased blood vessels and death.

[0003] The stent graft is cylindrical in shape as a whole, and consists of a metal frame and a thin artificial blood vessel covered thereon. The metal frame is mostly made of memory alloy, and the material of the thin artificial blood vessel is mostly made of polyester or polytetrafluoroethylene. Before the operation, the stent graft needs to be loaded into the outer tube of the delivery system, and the delivery system transports the loaded stent graft to the patient's vascular lesion site and releases it to achieve the treatment purpose; usually, the delivery system for delivering the stent graft to the patient's vascular lesion site includes a delivery device and a guide wire; the delivery device includes an operating handle, an outer tube, an inner tube, a guide wire tube and a stent graft fixing and releasing device; the guide wire tube passes through the inner tube, the inner tube passes through the outer tube, the outer tube and the inner tube are both connected to the operating handle, and the stent graft fixing and releasing device is connected to the proximal end of the inner tube; when delivering the stent graft to the human body, the first step is to install the stent graft in the proximal end of the delivery device, specifically, The coated stent is compressed as a whole into the outer tube, and the rear fixer fixes the rear end of the coated stent from the inside of the outer tube, and the proximal end of the coated stent is fixed to the coated stent fixing and releasing device, so that the coated stent fixing and releasing device restrains the proximal end of the coated stent so that the proximal end of the coated stent is in a retracted state; the second step is to pass the guide wire through the guide wire tube, and use the conveyor to percutaneously puncture along the guide wire to convey the coated stent fixing and releasing device loaded with the coated stent to the patient's vascular lesion site; the third step is to withdraw the outer tube using the operating handle to release the distal end of the coated stent from the outer tube and semi-release the coated stent; the fourth step is to withdraw the inner tube using the operating handle to release the proximal end of the coated stent by the coated stent fixing and releasing device, thereby completely releasing the coated stent; the fifth step is to reposition the outer tube using the operating handle; the sixth step is to withdraw the conveyor as a whole and the guide wire backwards.

[0004] In the prior art, the structure of the stent graft fixing and releasing device that restrains the proximal end of the stent graft is mostly a hard metal wire or a rigid metal fork structure. When the stent graft is fully released, the edges and corners of the rigid structure of the stent graft fixing and releasing device that restrains the proximal end of the stent graft can easily scratch and cut the blood vessels in narrow and curved blood vessel channels, causing blood vessel damage or even rupture. If the patient is not careful, it will cause fatal injuries to the patient, thus leading to high surgical difficulty and low surgical success rate. Summary of the invention

[0005] The purpose of the present invention is to provide a coated stent fixing and releasing device and a coated stent delivery system to alleviate the technical problems in the prior art that the coated stent fixing and releasing device is very easy to scratch the blood vessels in narrow and curved blood vessel channels, causing blood vessel damage or even rupture, which will cause fatal injuries to the patient if not handled with care, thereby leading to high surgical difficulty and low surgical success rate.

[0006] To achieve the above objectives, the embodiments of the present invention adopt the following technical solutions:

[0007] In a first aspect, an embodiment of the present invention provides a stent graft fixation and release device, comprising a guide seat, a fixator, a locking structure, and a tie rod made of a flexible material;

[0008] The direction extending from the proximal end of the guide seat toward the distal end of the guide seat is the axial direction of the guide seat, and the direction extending from the proximal end of the fixture to the distal end of the fixture is the axial direction of the fixture:

[0009] The guide seat is provided with a first mounting through hole penetrating the guide seat along the axial direction of the guide seat, and the fixture is provided with a second mounting through hole penetrating the fixture along the axial direction of the fixture;

[0010] There are multiple tie bars, one end of each of the tie bars is fixed to the fixture, and the tie bars are spaced apart in pairs around the radial circumferential surface of the fixture, the other ends of each of the tie bars are fixed to the guide seat by the locking structure, and when the fixture moves in a direction away from the guide seat, the tie bars can be detached from the locking structure.

[0011] In combination with the first aspect, an embodiment of the present invention provides a first possible implementation of the first aspect, wherein the locking structure includes an elastic locking ring, and the elastic locking ring is configured to: be able to squeeze and fix one end of the plurality of tie rods away from the fixer to the outer circumferential surface of the guide seat, or to squeeze and fix one end of the plurality of tie rods away from the fixer to the inner circumferential surface of the guide seat.

[0012] In combination with the first possible implementation of the first aspect, an embodiment of the present invention provides a second possible implementation of the first aspect, wherein a tie rod limiting groove is provided on the outer circumferential surface of the guide seat or the inner circumferential surface of the guide seat, the tie rod limiting groove extends along the axial direction of the guide seat, and one end of the tie rod limiting groove extends to the distal end surface of the guide seat.

[0013] In combination with the second possible implementation of the first aspect, an embodiment of the present invention provides a third possible implementation of the first aspect, wherein the depth of the tie rod limiting groove is greater than the thickness of the tie rod in a direction perpendicular to the length extension direction of the tie rod itself.

[0014] In combination with one of the first to third possible implementations of the first aspect, an embodiment of the present invention provides a fourth possible implementation of the first aspect, wherein a locking ring fixing groove extending along the radial circumferential direction of the guide seat is also provided on the inner circumferential surface of the guide seat or the outer circumferential surface of the guide seat.

[0015] In combination with the fourth possible implementation of the first aspect, the embodiment of the present invention provides a fifth possible implementation of the first aspect, wherein the depth of the locking ring fixing groove is greater than the thickness of the ring body of the elastic locking ring.

[0016] In combination with one of the first to third possible implementations of the first aspect, an embodiment of the present invention provides a sixth possible implementation of the first aspect, wherein an X-ray developer is connected to the elastic locking ring.

[0017] In combination with the first aspect, an embodiment of the present invention provides a seventh possible implementation of the first aspect, wherein the locking structure includes a tie rod extrusion groove arranged on the outer circumferential surface of the guide seat or the inner circumferential surface of the guide seat; the notch of the tie rod extrusion groove is configured to be able to extrude and fix the tie rod arranged inside the tie rod extrusion groove in the tie rod extrusion groove.

[0018] In combination with the first aspect, an embodiment of the present invention provides an eighth possible implementation of the first aspect, wherein the locking structure comprises a rib extrusion groove provided on the outer circumferential surface of the guide seat or the inner circumferential surface of the guide seat; the rib extrusion groove comprises a proximal groove and a distal groove, the distal groove extends along the axial direction of the guide seat, and the proximal end of the distal groove is connected to the proximal end of the proximal groove, the distal end of the distal groove extends to the distal end surface of the guide seat, and the depth of the proximal groove is greater than the depth of the distal groove;

[0019] The tie rod passes through the distal groove; an elastic stopper is provided at the end of the tie rod away from the fixator, and the elastic stopper is configured to be compressed to a maximum thickness of the elastic stopper that is less than the depth of the distal groove, and when the elastic stopper is not compressed, the maximum thickness of the elastic stopper is greater than the depth of the distal groove;

[0020] The notch of the proximal groove is configured to limit the elastic limiting head in the proximal groove.

[0021] In combination with the first aspect and one of the first to third and seventh and eighth possible implementations thereof, an embodiment of the present invention provides a ninth possible implementation of the first aspect, wherein an anti-slip structure is provided at a portion of the guide seat that contacts the reinforcement.

[0022] In combination with the first aspect and one of the first to third and seventh and eighth possible implementations, an embodiment of the present invention provides a tenth possible implementation of the first aspect, wherein the outer peripheral surface of the proximal end of the guide seat is a conical side surface whose diameter gradually increases from the proximal end of the guide seat toward the distal end of the guide seat.

[0023] In combination with the first aspect and one of the first to third and seventh and eighth possible implementations thereof, the embodiment of the present invention provides an eleventh possible implementation of the first aspect, wherein a plurality of positioning grooves are provided on the outer peripheral surface of the fixture, each of the positioning grooves is configured to accommodate a hanging ring provided at the proximal end of the stent graft, and the hanging ring at the proximal end of the stent graft is hooked on the fixture;

[0024] The plurality of tie bars pass through the plurality of positioning grooves one by one, or the ends of the plurality of tie bars fixedly connected to the fixture are connected to the plurality of positioning grooves one by one.

[0025] In combination with the eleventh possible implementation manner of the first aspect, the embodiment of the present invention provides a twelfth possible implementation manner of the first aspect, wherein a tie rod positioning groove is further provided on the outer peripheral surface of the fixator, one end of the tie rod positioning groove is connected to the positioning groove, and the other end of the tie rod positioning groove extends to the proximal end surface of the fixator.

[0026] In combination with the twelfth possible implementation of the first aspect, an embodiment of the present invention provides a thirteenth possible implementation of the first aspect, wherein the depth of the tie rod positioning groove is greater than the thickness of the tie rod in a direction perpendicular to the length extension direction of the tie rod itself.

[0027] In combination with the first aspect and one of the first to third and seventh and eighth possible implementations thereof, an embodiment of the present invention provides a fourteenth possible implementation of the first aspect, wherein the outer peripheral surface of the distal end of the fixture is a frustum side surface whose diameter gradually decreases from the proximal end of the fixture toward the distal end of the fixture.

[0028] In combination with the first aspect and one of the first to third and seventh and eighth possible implementations thereof, an embodiment of the present invention provides a fifteenth possible implementation of the first aspect, wherein an X-ray developer is connected to the reinforcement.

[0029] In a second aspect, an embodiment of the present invention provides a stent graft delivery system, comprising an operating handle, a guide wire tube, an inner tube, an outer tube, and a stent graft fixing and releasing device provided in the first aspect and one of its possible embodiments; wherein:

[0030] The wire guide tube passes through the inner tube, and the wire guide tube passes through the second mounting through hole, the proximal end of the wire guide tube is fixed inside the first mounting through hole; the proximal end of the inner tube is fixed to the distal end of the fixture; the distal ends of the outer tube and the inner tube are both connected to the operating handle, and the operating handle is configured to drive the outer tube and the inner tube to move forward and backward.

[0031] The embodiments of the present invention can achieve the following beneficial effects:

[0032] In the first aspect, an embodiment of the present invention provides a stent graft fixing and releasing device, which comprises a guide seat, a fixer, a locking structure and a tie rod made of a flexible material. Specifically, the direction extending from the proximal end of the guide seat toward the distal end of the guide seat is the axial direction of the guide seat, and the direction extending from the proximal end of the fixer to the distal end of the fixer is the axial direction of the fixer: a first mounting through hole is provided on the guide seat and passes through the guide seat along the axial direction of the guide seat, and a second mounting through hole is provided on the fixer and passes through the fixer along the axial direction of the fixer; there are a plurality of tie rods, one end of each of the plurality of tie rods is fixed to the fixer, and the plurality of tie rods are spaced in pairs around the radial circumferential surface of the fixer, and the other ends of each of the plurality of tie rods are fixed to the guide seat by the locking structure, and when the fixer moves in a direction away from the guide seat, the tie rods can be detached from the locking structure.

[0033] In the stent graft fixing and releasing device provided in the embodiment of the present invention, firstly, by adopting tie rods made of flexible materials, no sharp edges are generated when bending, thereby ensuring the flexibility of the structure of the stent graft fixing and releasing device that constrains the proximal end of the stent graft, and greatly reducing the scratching damage to the blood vessel during surgery. On this basis, pay attention to the following operating matters, such as but not limited to, making the tie rods passing through the proximal end hanging ring position of the stent graft longer, so that when the outer tube is withdrawn to semi-release the stent graft, the constrained deformation of the stent graft is smaller; thereby, when the stent graft is fully released, the force released by the stent graft is not that large, thereby achieving a buffering effect, further protecting the blood vessel, and even not causing damage to the blood vessel. Scraping, thereby greatly reducing the damage to the blood vessels during the operation; secondly, in the prior art, before withdrawing the entire conveyor and the guide wire backwards, it is necessary to use the operating handle of the conveyor to reset the outer tube to prevent the edges of the rigid structure used to restrain the front end of the coated stent from continuing to damage the blood vessels during withdrawal. This operation consumes a certain amount of surgical time. In contrast, the present embodiment does not require this step and can directly withdraw the entire conveyor, thereby reducing the doctor's operating steps and improving the efficiency of the operation; in addition, the coated stent fixing and releasing device provided in the present embodiment has a simple overall structure and is easy to install and adjust, thereby improving the efficiency of preoperative preparation and debugging of surgical instruments.

[0034] In summary, the present embodiment at least alleviates the problem in the prior art that the structure of the proximal end of the stent graft in the fixing and releasing device of the stent graft is mostly a hard metal wire or a rigid metal fork-shaped structure, which can easily scratch the blood vessels in narrow and curved blood vessel channels, causing blood vessel damage or even rupture, which may cause fatal injuries to the patient if not handled with care, thus leading to technical problems of high surgical difficulty and low surgical success rate; at the same time, it improves the surgical efficiency, as well as the efficiency of preparation and debugging of surgical instruments before surgery.

[0035] In addition, the second aspect of the embodiment of the present invention also provides a coated stent delivery system, including an operating handle, a guide wire tube, an inner tube, an outer tube and the coated stent fixing and releasing device provided by the first aspect; wherein: the guide wire tube passes through the inner tube, and the guide wire tube passes through the second mounting through hole, and the proximal end of the guide wire tube is fixed to the inside of the first mounting through hole; the proximal end of the inner tube is fixed to the distal end of the fixer; the distal end of the outer tube and the distal end of the inner tube are both connected to the operating handle, and the operating handle is configured to be able to drive the outer tube and the inner tube to move forward and backward.

[0036] Since the coated stent delivery system provided by the embodiment of the present invention includes the coated stent fixation and release device provided by the first aspect, the coated stent delivery system provided by the embodiment of the present invention can achieve all the beneficial effects that can be achieved by the coated stent fixation and release device provided by the first aspect. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0038] Figure 1 A schematic diagram of the overall structure of a stent graft fixing and releasing device provided in an embodiment of the present invention;

[0039] Figure 2 for Figure 1 A magnified view of the local structure of part A;

[0040] Figure 3 An exploded view of the overall structure of the stent graft fixing and releasing device provided in an embodiment of the present invention;

[0041] Figure 4 It is a schematic diagram of the overall structure of the fixed base in the guide seat in the embodiment of the present invention;

[0042] Figure 5 is a schematic diagram of the overall structure of a fixer in an embodiment of the present invention;

[0043] Figure 6 An assembly diagram of a stent graft fixing and releasing device and an inner tube, a rear fixator and a guide wire tube in a stent graft delivery system provided in an embodiment of the present invention;

[0044] Figure 7 An exploded view of the assembly between the stent graft fixing and releasing device and the inner tube, outer tube, rear fixator and guide wire tube in the stent graft delivery system provided in an embodiment of the present invention;

[0045] Figure 8 It is a schematic diagram of the overall structure of a fixed base in a guide seat in a second optional implementation manner of the locking structure in an embodiment of the present invention;

[0046] Fig. 9 It is a schematic diagram of the overall structure of a fixed base in a guide seat in a third optional implementation manner of the locking structure in an embodiment of the present invention;

[0047] Fig.10 This is a schematic diagram of the overall structure of a fixed base in which an elastic locking ring is installed in a guide seat corresponding to the inside of the fixed base in a first optional implementation manner of the locking structure in an embodiment of the present invention.

[0048] Icon: 1-guide seat; 110-first mounting hole; 11-guide head; 111-first connecting hole; 12-fixing base; 121-second connecting hole; 101-tension bar limiting groove; 102-locking ring fixing groove; 103-tension bar extrusion groove; 1031-proximal groove; 1032-distal groove; 2-fixator; 120-second mounting hole; 21-positioning groove; 22-tension bar positioning groove; 23-tension bar fixing hole; 3-elastic locking ring; 4-tension bar; 5-laminated bracket; 6-guide wire tube; 61-welding tube; 7-inner tube; 8-outer tube; 81-rear fixator. DETAILED DESCRIPTION

[0049] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings here can be arranged and designed in various different configurations.

[0050] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0051] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0052] In the description of the present invention, it should be noted that the terms "upper", "lower", "vertical", "horizontal", "inner", "outer", etc. indicate the orientation or position relationship based on the orientation or position relationship shown in the drawings, or the orientation or position relationship in which the product of the invention is usually placed when in use, which is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", "third", etc. are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

[0053] In addition, the terms "horizontal", "vertical" and the like do not mean that the components are required to be absolutely horizontal or suspended, but can be slightly tilted. For example, "horizontal" only means that its direction is more horizontal than "vertical", and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0054] In the description of the present invention, it is also necessary to explain that, unless otherwise clearly specified and limited, the terms "setting", "installation" and "connection" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0055] Some embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. In the absence of conflict, the following embodiments and features in the embodiments can be combined with each other.

[0056] Embodiment 1

[0057] This embodiment provides a stent graft fixing and releasing device, referring to Figures 1 to 3 The stent graft fixing and releasing device comprises a guide seat 1, a fixture 2, a locking structure and a tie rod 4 made of a flexible material. Specifically, the direction extending from the proximal end of the guide seat 1 toward the distal end of the guide seat 1 is the axial direction of the guide seat 1, and the direction extending from the proximal end of the fixture 2 to the distal end of the fixture 2 is the axial direction of the fixture 2: a first mounting through hole 110 is provided on the guide seat 1 and passes through the guide seat 1 along the axial direction of the guide seat 1, and a second mounting through hole 120 is provided on the fixture 2 and passes through the fixture 2 along the axial direction of the fixture 2; there are a plurality of tie rods 4, one end of each of the plurality of tie rods 4 is fixed to the fixture 2, and the plurality of tie rods 4 are spaced in pairs around the radial circumferential surface of the fixture 2, and the other ends of each of the plurality of tie rods 4 are fixed to the guide seat 1 by the locking structure, and when the fixture 2 moves in a direction away from the guide seat 1, the tie rods 4 can be separated from the aforementioned locking structure.

[0058] In this embodiment, the proximal end refers to the end of the medical device close to the patient's blood vessel when working, and the distal end refers to the end of the medical device close to the doctor, wherein: the flexible material for making the tie rod 4 can be but not limited to PA (polyamide, polyamide, commonly known as nylon), PP (Polypropylene, polypropylene), PET (Polyethylene terephthalate, commonly known as polyester resin) and other polymer materials, or soft stainless steel, cobalt-chromium alloy, titanium alloy and other wire materials, preferably, the flexible material used is selected from inelastic or less elastic materials to avoid the tie rod 4 from being tensilely deformed; Figure 3 As shown, the guide seat 1 includes a guide head 11 and a fixed base 12. The distal end of the guide head 11 is connected to the proximal end of the fixed base 12. The fixed base 12 is used to cooperate with the locking structure to fix the tie rod 4. The guide head 11 and the fixed base 12 can be an integrally formed structure or can be as shown in FIG. Figure 3As shown, a first connecting hole 111 is provided on the distal end surface of the guide head 11. Figure 4 As shown, a second connecting hole 121 is provided on the proximal end surface of the fixed base 12, and the guide head 11 is connected to the fixed base 12 by connecting a rod in the first connecting hole 111 on the guide head 11 or in the second connecting hole 121 on the fixed base 12. The rod can be fixed to the first connecting hole 111 and the second connecting hole 121 by interference fit or other connection methods; there are many specific fixing methods for fixing one end of the plurality of tie bars 4 to the fixator 2, such as but not limited to the following Figures 1 to 3 as well as Figure 5 As shown, a tie rod fixing hole 23 is provided on the circumferential surface of the fixer 2, and one end of the tie rod 4 is passed through the tie rod fixing hole 23 and then tied, so as to be fixed to the fixer 2. Alternatively, one end of the tie rod 4 can be fixedly connected to the fixer 2 by bonding or welding, and the tie rod 4 and the fixer 2 can also be an integrally formed structure; preferably, a plurality of tie rods 4 are spaced apart in pairs and evenly distributed around the radial circumferential surface of the fixer 2.

[0059] When in use, the first step is to install the stent graft as a whole on the stent graft delivery system. Specifically, refer to Figure 6 and Figure 7 , compress the coated stent 5 into the outer tube 8 of the conveyor, and fix the rear end of the coated stent from the inside of the outer tube 8 with the rear fixer 81, and fix the inner tube 7 to the distal end of the fixer 2 by threading, welding, interference fitting or other methods, and the proximal end of the inner tube 7 can be extended into the second mounting through hole 120 on the fixer 2, and the proximal end of the guide wire tube 6 is fixedly connected to the first mounting through hole 110 on the guide seat 1. There are many fixing methods, such as but not limited to the following: Figure 7As shown, a welding tube 61 is connected to the proximal end of the guide wire tube 6, and the welding tube 61 is welded to the first mounting through hole 110, or a connecting thread is provided on the hole wall of the first mounting through hole 110, and the proximal end of the guide wire tube 6 is threadedly connected to the first mounting through hole 110, etc.; the opposite end of the tie rod 4 fixed to one end of the fixer 2, that is, the free end of the tie rod 4, passes through a hanging ring provided at the proximal end of the stent graft 5, and then the free end of the tie rod 4 is fixed to the guide seat 1 by using a locking structure. At this time, the stent graft fixing and releasing device restrains the proximal end of the stent graft so that the proximal end of the stent graft is in a retracted state; in the second step, the guide guide The wire passes through the guide wire tube 6, and the conveyor is used to deliver the stent graft fixing and releasing device loaded with the stent graft 5 to the patient's vascular lesion position through percutaneous puncture along the guide wire; the third step is to use the operating handle of the conveyor to withdraw the outer tube 8 to release the distal end of the stent graft 5 from the outer tube 8 to semi-release the stent graft 5; the fourth step is to use the operating handle of the conveyor to withdraw the inner tube 7, and the inner tube 7 withdraws with the fixator 2, pulling the tie rod 4, and the free end of the tie rod 4 is separated from the locking structure, thereby releasing the proximal end of the stent graft 5, thereby completely releasing the stent graft 5; the fifth step is to withdraw the conveyor as a whole and the guide wire backward. Among them, the hanging ring on the stent at the proximal end of the stent graft 5 can be directly bent by the metal frame of the stent graft 5, or a hanging ring can be set separately and connected to the proximal end of the metal frame of the stent graft 5.

[0060] In the stent graft fixing and releasing device provided in the present embodiment, firstly, by adopting the tie rod 4 made of flexible material, no sharp corners are generated when bending, so that the flexibility of the structure of the stent graft fixing and releasing device that restrains the proximal end of the stent graft 5 can be ensured, and the scratching damage to the blood vessel can be reduced to a great extent during the operation. On this basis, pay attention to the following operating matters, such as but not limited to, making the tie rod 4 passing through the proximal end of the stent graft 5 longer, so that when the outer tube 8 is withdrawn to semi-release the stent graft 5, the deformation of the stent graft 5 is less constrained; thus, when the stent graft 5 is completely released, the force released by the stent graft 5 is not that large, so that a buffering effect can be achieved, and the blood vessel can be further protected, and even no damage to the blood vessel can be caused. No scratches are caused, thereby greatly reducing the damage to the blood vessels during the operation; secondly, in the prior art, before withdrawing the entire conveyor and the guide wire backwards, it is necessary to use the operating handle of the conveyor to reset the outer tube 8 to prevent the edges of the rigid structure used to restrain the front end of the coated stent 5 from continuing to damage the blood vessels during withdrawal. This operation consumes a certain amount of surgical time. In contrast, the present embodiment does not require this step and can directly withdraw the entire conveyor, thereby reducing the doctor's operating steps and improving the efficiency of the operation; in addition, the coated stent fixing and releasing device provided in the present embodiment has a simple overall structure and is easy to install and adjust, thereby improving the efficiency of the preparation and debugging of surgical instruments before surgery.

[0061] In summary, the present embodiment at least alleviates the problem in the prior art that the structure of the proximal end of the stent graft in the fixing and releasing device of the stent graft is mostly a hard metal wire or a rigid metal fork-shaped structure, which can easily scratch the blood vessels in narrow and curved blood vessel channels, causing blood vessel damage or even rupture, which may cause fatal injuries to the patient if not handled with care, thus leading to technical problems of high surgical difficulty and low surgical success rate; at the same time, it improves the surgical efficiency, as well as the efficiency of preparation and debugging of surgical instruments before surgery.

[0062] In this embodiment, the above locking structure has various specific structural forms, such as but not limited to:

[0063] In the first optional implementation of the locking structure of this embodiment, refer to Figures 1 to 3 The locking structure includes an elastic locking ring 3, which is configured to squeeze and fix the end of the plurality of reinforcing bars away from the fixer 2 to the outer peripheral surface of the guide seat 1, or, in combination with Fig.10 , the ends of the multiple tension rods away from the fixer 2 are squeezed and fixed to the inner circumference of the guide seat 1; wherein the guide seat 1 and the elastic locking ring 3 can be a detachable split structure, and the guide seat 1 and the elastic locking ring 3 are mutually fitted, or the elastic locking ring 3 is fixed to the inner circumference of the guide seat 1 or the outer circumference of the guide seat 1, and a through groove penetrating the elastic locking ring 3 along the axial direction of the guide seat 1 is provided on the side of the elastic locking ring 3 facing the guide seat 1, for the tension rod 4 to pass through, and the part of the tension rod 4 located inside the through groove after passing through the through groove is squeezed and fixed between the elastic locking ring 3 and the guide seat 1. The specific extrusion and fixing principle of the locking structure for squeezing and fixing the tie rod 4 in this optional embodiment depends on the elastic properties of the elastic locking ring 3. The elastic locking ring 3 applies a large pressure on the tie rod 4, so that there is a large friction between the tie rod 4 and the guide seat 1, and between the tie rod 4 and the elastic locking ring 3. A large pulling force needs to be applied to the tie rod 4 to overcome the friction in order to pull the tie rod 4 out of the elastic locking ring 3; the elastic locking ring 3 can be but is not limited to an annular structure made of rubber, silicone or polymer material or other elastic material, or a spring coil, etc., or a rigid annular structure with a rigid material at the center, and an elastic layer made of rubber, silicone or polymer material or other elastic material wrapped around the rigid annular structure, etc. After being mounted on the outer circumference or inner circumference of the guide seat 1, it is in a compressed and tight state, which can provide sufficient friction to ensure that the tie rod 4 does not separate from the guide seat 1; the specific shape of the elastic locking ring 3 includes but is not limited to a circular ring, an elliptical ring, a rectangular ring or other annular shapes.

[0064] Reference Figure 4 and Fig.10 , combined with Figures 1 to 3In the optional embodiment in which the locking structure includes an elastic locking ring 3, it is more preferred that a tie rod limiting groove 101 is provided on the outer circumference of the guide seat 1 or the inner circumference of the guide seat 1, and the tie rod limiting groove 101 extends along the axial direction of the guide seat 1, and one end of the tie rod limiting groove 101 extends to the distal end surface of the guide seat 1. The tie rod limiting groove 101 corresponds to the tie rod 4 one by one, and is used to accommodate the tie rod 4 and limit the tie rod 4, so as to avoid interference between adjacent tie rods 4 or between the tie rod 4 and other structures during surgery. Preferably, but not limited to, the depth of the reinforcing bar limiting groove 101 is greater than the thickness of the reinforcing bar 4 in the direction perpendicular to the extension direction of the reinforcing bar 4 itself. For example, but not limited to, the cross-sectional shape of the reinforcing bar 4 in the direction perpendicular to the extension direction of the reinforcing bar 4 itself is circular. In this case, the depth of the reinforcing bar limiting groove 101 is greater than the diameter of the cross-sectional shape of the reinforcing bar 4 in the direction perpendicular to the extension direction of the reinforcing bar 4 itself. Therefore, the reinforcing bar 4 can be limited by the reinforcing bar limiting groove 101 to prevent the reinforcing bar 4 from exposing the reinforcing bar limiting groove 101 and scraping the blood vessel wall, thereby further improving the safety of the operation.

[0065] In addition, continue to refer to Figure 4 and Fig.10 , combined with Figures 1 to 3 In an optional embodiment in which the locking structure includes an elastic locking ring 3, it is more preferred that a locking ring fixing groove 102 extending along the radial circumferential direction of the guide seat 1 is also provided on the inner circumferential surface of the guide seat 1 or the outer circumferential surface of the guide seat 1. Preferably, the depth of the locking ring fixing groove 102 is greater than the diameter of the elastic locking ring 3, thereby limiting the elastic locking ring 3; it is further preferred that the above-mentioned locking ring fixing groove 102 has a plurality of locking ring fixing grooves 102 spaced apart in the axial direction of the guide seat 1, and a plurality of elastic locking rings 3 are correspondingly provided to further enhance the squeezing and fixing effect on the free end of the tie rod 4, thereby preventing the free end of the tie rod 4 from detaching from the elastic locking ring 3 before releasing the coated stent 5, and improving the success rate of the operation.

[0066] In addition, in order to provide accurate release of the coated stent 5 during the operation, in an optional embodiment in which the locking structure includes an elastic locking ring 3, it is more preferred that an X-ray developer is connected to the elastic locking ring 3 so that the process of the tensioning rod 4 being pulled can be clearly detected under the X-ray, and the opening time and opening position of the coated stent 5 during the release process can be known more accurately, thereby improving the accuracy of the operation.

[0067] In the second optional implementation of the locking structure of this embodiment, refer to Figure 8 , combined with Figures 1 to 3 The locking structure includes a steel bar extrusion groove 103 disposed on the outer circumference of the guide seat 1 or the inner circumference of the guide seat 1; the notch of the steel bar extrusion groove 103 is configured to be able to squeeze and fix the steel bar disposed inside the steel bar extrusion groove 103 into the steel bar extrusion groove 103, specifically, as Figure 8As shown, the thickness of the reinforcing bar 4 in the direction perpendicular to the length of the reinforcing bar 4 itself is slightly larger than the depth of the reinforcing bar extrusion groove 103. The notch of the reinforcing bar extrusion groove 103 is a narrow gap structure. When the reinforcing bar 4 is inserted into the reinforcing bar extrusion groove 103, the notch of the reinforcing bar extrusion groove 103 squeezes and fixes the reinforcing bar 4 inside the reinforcing bar extrusion groove 103. There is a large friction between the reinforcing bar 4 and the reinforcing bar extrusion groove 103. A large pulling force needs to be applied to the reinforcing bar 4 to overcome the friction in order to pull the reinforcing bar 4 out of the reinforcing bar extrusion groove 103.

[0068] In a third optional implementation of the locking structure of this embodiment, as Fig. 9 As shown, combined Figures 1 to 3 The locking structure includes a tensioning extrusion groove 103 arranged on the outer circumferential surface of the guide seat 1 or the inner circumferential surface of the guide seat 1; the tensioning extrusion groove 103 includes a proximal groove 1031 and a distal groove 1032, the distal groove 1032 extends along the axial direction of the guide seat 1, and the proximal end of the distal groove 1032 is connected to the proximal end of the proximal groove 1031, and the distal end of the distal groove 1032 extends to the distal end surface of the guide seat 1, and the depth of the proximal groove 1031 is greater than the depth of the distal groove 1032. The tie rod 4 passes through the distal groove 1032; an elastic limit head is provided at the end of the tie rod 4 away from the fixator 2, and the elastic limit head is configured to be compressed to a maximum thickness of the elastic limit head that is less than the depth of the distal groove 1032, and when the elastic limit head is not compressed, the maximum thickness of the elastic limit head is greater than the depth of the distal groove 1032; the notch of the proximal groove 1031 is configured to limit the elastic limit head in the proximal groove 1031. Preferably, the shape of the elastic limit head is set to be a teardrop shape with a thickness gradually decreasing from the proximal end of the guide seat 1 to the distal end of the guide seat 1. When the tie rod 4 is pulled backward, the elastic limit head is elastically deformed to disengage from the proximal groove 1031, and overcomes the friction between the distal groove 1032 to allow the tie rod 4 to be completely pulled out of the tie rod extrusion groove 103; combined with Figure 3 Preferably, the proximal end of the proximal groove 1031 can extend to the proximal end surface of the fixed base 12, and under this scheme, it is preferred that the fixed base 12 and the guide head 11 are detachably connected to facilitate assembly.

[0069] In addition, in various optional implementations of the present embodiment, it is more preferred that an anti-slip structure is provided at the portion of the guide seat 1 that contacts the tie rod 4. The anti-slip structure may be anti-slip grooves provided on the guide seat 1, or multiple silicone tubes bonded to the guide seat 1, or other anti-slip structures may be used.

[0070] In addition, continue to refer to Figure 4 , combined with Figures 1 to 3, in each alternative implementation of this embodiment, preferably, the outer peripheral surface of the proximal end of the guiding seat 1 is a frustum side surface with a diameter gradually increasing from the proximal end of the guiding seat 1 towards the distal end of the guiding seat 1. This frustum side surface can prevent the proximal end of the guiding seat 1 from scraping the blood vessel during the process of advancing the guiding seat 1 into the blood vessel or during the process of retracting the guiding seat 1 through the operating handle, so as to protect the blood vessel and further reduce the damage to the blood vessel caused by the surgery. Specifically, this frustum side surface is provided on the guiding head 11.

[0071] In addition, referring to Figure 5 and combining with Figures 1 to 3 , in each alternative implementation of this embodiment, preferably, a plurality of positioning grooves 21 are provided on the outer peripheral surface of the fixator 2. Each positioning groove 21 is configured to be able to accommodate the hanging rings provided at the proximal end of the covered stent 5 and hook the hanging rings at the proximal end of the covered stent 5 to the fixator 2. For example, as Figure 5 shown, the positioning groove 21 is formed in a "冂" shape opening towards the distal end or in a "C" shape opening towards the distal end. When the hanging rings at the proximal end of the covered stent 5 are accommodated in the corresponding positioning grooves 21, the proximal end of the covered stent 5 is hooked to the fixator 2 and the covered stent 5 cannot shake, so as to play a role in fixing the proximal end of the covered stent 5. Further referring to Figure 5 , on the circumferential surface of the fixator 2, a tendon fixing hole 23 is provided inside each positioning groove 21. A plurality of tendons 4 pass through the plurality of positioning grooves 21 in a one-to-one correspondence, that is, a plurality of tendons 4 pass through the plurality of tendon fixing holes 23 in a one-to-one correspondence. The tendons 4 are fixedly connected to the fixator 2 by tying knots after passing through the tendon fixing holes 23. Or, the tendon fixing holes 23 may not be provided as Figure 5 shown, and one end of the plurality of tendons 4 fixedly connected to the fixator 2 is connected to the plurality of positioning grooves 21 in a one-to-one correspondence. The specific connection method can be bonding or welding, etc.

[0072] Continuing to refer to Figure 5 and combining with Figures 1 to 3 , further preferably, a tendon positioning groove 22 is also provided on the outer peripheral surface of the fixator 2. One end of the tendon positioning groove 22 is communicated with the positioning groove 21, and the other end of the tendon positioning groove 22 extends to the proximal end face of the fixator 2.

[0073] Preferably, the depth of the tendon positioning groove 22 is greater than the thickness of the tendon 4 in the direction perpendicular to the extension direction of the length of the tendon 4 itself.

[0074] In addition, continuing to refer to Figure 5 and combining with Figures 1 to 3 and Figure 7In various optional implementations of the present embodiment, it is more preferred that the outer peripheral surface of the distal end of the fixator 2 is a conical side surface whose diameter gradually decreases from the proximal end of the fixator 2 toward the distal end of the fixator 2. The setting of the conical side surface can prevent the distal end of the fixator 2 from scraping the blood vessel when the inner tube 7 is withdrawn by the operating handle to withdraw the fixator 2, so as to protect the blood vessel and further reduce the damage to the blood vessel caused by the operation.

[0075] In addition, in order to provide accurate release of the coated stent 5 during surgery, in various optional implementations of the present embodiment, it is more preferred that an X-ray developer is connected to the tie rod 4 so that the process of the tie rod 4 being pulled can be clearly detected under X-rays, and the opening time and opening position of the coated stent 5 during the release process can be known more accurately, thereby improving the accuracy of the surgery.

[0076] Embodiment 2

[0077] This embodiment provides a stent graft delivery system, referring to Figure 6 , Figure 7 , combined with Figures 1 to 5 The stent graft delivery system includes an operating handle, a guide wire tube 6, an inner tube 7, an outer tube 8, and a stent graft fixing and releasing device provided in any optional embodiment of Example 1. The guide wire tube 6 passes through the inner tube 7, and the guide wire tube 6 passes through the second mounting through hole 120, and the proximal end of the guide wire tube 6 is fixed inside the first mounting through hole 110; the proximal end of the inner tube 7 is fixed to the distal end of the fixator 2; the distal ends of the outer tube 8 and the inner tube 7 are both connected to the operating handle, and the operating handle is configured to drive the outer tube 8 and the inner tube 7 to move forward and backward.

[0078] Since the coated stent delivery system provided in this embodiment includes the coated stent fixing and releasing device described in Example 1, the coated stent delivery system provided in this embodiment can achieve all the beneficial effects that can be achieved by the coated stent fixing and releasing device in Example 1. Specifically, it can be obtained by referring to the various optional or preferred implementations in Example 1. Among them, in each optional implementation of this embodiment, preferably, the coated stent delivery system also includes a rear fixer 81, and the rear fixer 81 is arranged in the outer tube 8. The inner tube 7 passes through the rear fixer 81, and the distal end of the rear fixer 81 is connected to an operating handle. The operating handle is also configured to be able to drive the rear fixer 81 to move back and forth inside the outer tube 8, so that the front end of the rear fixer 81 abuts against or releases the rear end of the coated stent 5, thereby increasing the stability of the coated stent 5 during delivery.

[0079] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A stent graft fixation and release device, Features: It comprises a guide seat (1), a fixer (2), a locking structure and a tie rod (4) made of a flexible material; The direction extending from the proximal end of the guide seat (1) toward the distal end of the guide seat (1) is taken as the axial direction of the guide seat (1), and the direction extending from the proximal end of the fixator (2) toward the distal end of the fixator (2) is taken as the axial direction of the fixator (2): The guide seat (1) is provided with a first mounting through hole (110) penetrating the guide seat (1) along the axial direction of the guide seat (1), and the fixture (2) is provided with a second mounting through hole (120) penetrating the fixture (2) along the axial direction of the fixture (2); The plurality of tie bars (4) are provided, one end of each of the plurality of tie bars (4) is fixed to the fixture (2), and the plurality of tie bars (4) are spaced apart in pairs around the radial circumferential surface of the fixture (2), the other ends of each of the plurality of tie bars (4) are fixed to the guide seat (1) by the locking structure, and when the fixture (2) moves in a direction away from the guide seat (1), the tie bars (4) can be separated from the locking structure; The locking structure comprises an elastic locking ring (3), wherein the elastic locking ring (3) is configured to: press and fix one end of the plurality of tie bars away from the fixer (2) to the outer peripheral surface of the guide seat (1), or press and fix one end of the plurality of tie bars away from the fixer (2) to the inner peripheral surface of the guide seat (1); A tie rod limiting groove (101) is provided on the outer circumferential surface of the guide seat (1) or the inner circumferential surface of the guide seat (1), the tie rod limiting groove (101) extends along the axial direction of the guide seat (1), and one end of the tie rod limiting groove (101) extends to the distal end surface of the guide seat (1); A lock ring fixing groove (102) extending in the radial circumferential direction of the guide seat (1) is also provided on the inner circumferential surface of the guide seat (1) or the outer circumferential surface of the guide seat (1); A plurality of positioning grooves (21) are provided on the outer peripheral surface of the fixator (2), and each of the positioning grooves (21) is configured to accommodate a hanging ring provided at the proximal end of the coated stent (5), and to hook the hanging ring at the proximal end of the coated stent (5) on the fixator (2); a plurality of the tie rods (4) pass through the plurality of the positioning grooves (21) in a one-to-one correspondence, or a plurality of the ends of the tie rods (4) fixedly connected to the fixator (2) are connected in a one-to-one correspondence to the plurality of the positioning grooves (21).

2. The stent graft fixing and releasing device according to claim 1, Features: The depth of the tie rod limiting groove (101) is greater than the thickness of the tie rod (4) in a direction perpendicular to the length extension direction of the tie rod (4) itself.

3. The stent graft fixing and releasing device according to claim 1, Features: The depth of the locking ring fixing groove (102) is greater than the thickness of the ring body of the elastic locking ring (3).

4. The stent graft fixing and releasing device according to claim 1 or 2, Features: An X-ray developing object is connected to the elastic locking ring (3).

5. The stent graft fixing and releasing device according to claim 1 or 2, Features: An anti-slip structure is provided at a portion of the guide seat (1) that contacts the tie rod (4).

6. The stent graft fixing and releasing device according to claim 1 or 2, Features: The outer peripheral surface of the proximal end of the guide seat (1) is in the form of a truncated cone side surface whose diameter gradually increases from the proximal end of the guide seat (1) toward the distal end of the guide seat (1).

7. The stent graft fixing and releasing device according to claim 6, Features: A tie rod positioning groove (22) is also provided on the outer peripheral surface of the fixator (2), one end of the tie rod positioning groove (22) is communicated with the positioning groove (21), and the other end of the tie rod positioning groove (22) extends to the proximal end surface of the fixator (2).

8. The stent graft fixing and releasing device according to claim 7, Features: The depth of the tie rod positioning groove (22) is greater than the thickness of the tie rod (4) in a direction perpendicular to the length extension direction of the tie rod (4) itself.

9. The stent graft fixing and releasing device according to claim 1 or 2, Features: The outer peripheral surface of the distal end of the fixator (2) is in the form of a frustum-shaped side surface whose diameter gradually decreases from the proximal end of the fixator (2) toward the distal end of the fixator (2).

10. The stent graft fixing and releasing device according to claim 1 or 2, Features: An X-ray developing object is connected to the tensioning rod (4).

11. A stent graft delivery system, Features: It comprises an operating handle, a guide wire tube (6), an inner tube (7), an outer tube (8), and a stent graft fixing and releasing device according to any one of claims 1 to 9; wherein: The wire guide tube (6) passes through the inner tube (7), and the wire guide tube (6) passes through the second mounting through hole (120), and the proximal end of the wire guide tube (6) is fixed inside the first mounting through hole (110); the proximal end of the inner tube (7) is fixed to the distal end of the fixture (2); The distal ends of the outer tube (8) and the inner tube (7) are both connected to the operating handle, and the operating handle is configured to drive the outer tube (8) and the inner tube (7) to move forward and backward.

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