Cutting tube, sheath tube and delivery system

Abstract

The invention provides a cutting tube, a sheathing canal and a conveying system, the cutting tube comprises an expansion section and a bending section, the expansion section and the bending section are arranged in the axial direction of the cutting tube, and the expansion section is located at the far end of the bending section; the expansion section is used for expanding outwards in the radial direction of the cutting tube when the valve prosthesis is conveyed and / or recycled; the bending section is used for bending in the process of conveying and / or recovering the valve prosthesis. According to the configuration, the cutting tube comprises the expansion section and the bent section, the expansion section is arranged at the far end of the cutting tube and can expand outwards in the radial direction of the cutting tube in the process of conveying and recycling the valve prosthesis, and the valve prosthesis is recycled; meanwhile, the bent section is bent in the process of conveying the valve prosthesis, so that the cutting tube has the performance of bending and recovering the valve prosthesis, the practicability of the cutting tube is improved, and the safety performance is improved while an operator conveniently operates the cutting tube.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, in particular to a cutting tube, a sheath tube and a delivery system. Background Art

[0002] The artificial heart valve delivery system currently on the market can deliver artificial valve prostheses to specific locations in the human heart to replace diseased valves. The artificial heart valve delivery system is mainly composed of a handle assembly, a catheter assembly, and an artificial valve prosthesis. The distal end of the catheter passes through the human artery to the diseased valve of the human body, and the handle assembly is used to control the bending of the distal end of the catheter and the release and recovery of the artificial valve.

[0003] The distal end of the catheter is a sheath for accommodating the compressed artificial valve prosthesis. The distal end of the sheath has a tip guide head and the rear end of the sheath has a fixed head. The sheath portion between the tip guide head and the fixed head is the placement area for the compressed artificial valve prosthesis. When the sheath reaches the diseased valve of the human body, first operate the handle to bend the sheath, so that the sheath and the valve ring are on the same axis, and then operate the handle to withdraw the sheath backward relative to the human valve prosthesis. The artificial valve prosthesis gradually expands from the compressed state until it is fully expanded and placed at the diseased valve. If the artificial valve prosthesis is found to be in the wrong position during the release process, the handle can be re-operated to move the sheath forward relative to the artificial valve prosthesis, compress the expanded artificial valve prosthesis, and recycle it into the sheath, adjust the position and release it again.

[0004] The sheath of the artificial valve delivery system currently on the market is generally composed of a three-layer structure, of which the innermost layer is made of PTFE (Polytetrafluoroethylene), the middle layer is a hypotube cut from a nickel-titanium alloy or stainless steel tube, and the outermost layer is a coated polymer layer. In order to meet the requirements of the operation, before the artificial valve prosthesis is released, the sheath needs to be bent to achieve a coaxial position with the diseased valve ring. After the artificial valve prosthesis is released, it needs to be recovered. The distal end of the sheath is trumpet-shaped due to force, and the sheath needs to withstand a lot of pressure to compress the stent to successfully recover the artificial valve prosthesis.

[0005] Due to the high design requirements for the sheath, it needs to have both bending flexibility and a certain degree of rigidity. However, most of the artificial valve delivery systems on the market have the function of being recyclable, but cannot have the performance of being bendable and coaxial, and cannot well meet the needs of patients and operators. Summary of the invention

[0006] The purpose of the present invention is to provide a cutting tube, a sheath tube and a delivery system to solve the problem that the existing artificial valve delivery system cannot take into account both the recyclability and the bending coaxial performance.

[0007] In order to achieve the above object, the present invention provides a cutting tube, comprising: an expansion section and a bending section, wherein the expansion section and the bending section are arranged along the axial direction of the cutting tube, and the expansion section is located at the distal end of the bending section;

[0008] The expansion section is used to expand outwardly along a direction that is angled with the radial direction of the cutting tube when the valve prosthesis is being transported and / or recovered; the bending section is used to bend during the process of transporting and / or recovering the valve prosthesis.

[0009] Optionally, the expansion section includes a grid unit, and the grid unit is formed by a plurality of first incisions that are sequentially connected along the axial direction of the cutting tube and the circumferential direction of the cutting tube.

[0010] Optionally, the curved section includes a plurality of second cutouts, which are arranged along the axial direction of the cutting tube and along the circumferential direction of the cutting tube, and the extension direction of the second cutouts is arranged at an angle to the circumferential direction of the cutting tube.

[0011] Optionally, the bending section further includes a plurality of connecting cuts, at least two second cuts adjacent to each other along the circumference of the cutting tube form a second cut group, and the second cuts in each second cut group are connected via the connecting cut.

[0012] Optionally, the bending section further includes a plurality of stress holes, which are located at two ends of the second incision group along the circumference of the cutting tube and are located at the same axial position as the second incision in the second incision group.

[0013] Optionally, the expansion section comprises a spiral unit, and the spiral unit is formed by a spiral cut coiled along the axial direction of the cutting tube.

[0014] Optionally, the curved section includes a plurality of third incisions, each of which has an opening that is open toward the circumference of the cutting tube. The plurality of third incisions are arranged along the circumference of the cutting tube and along the axial direction of the cutting tube. The openings of two adjacent third incisions along the circumference of the cutting tube are oriented in opposite directions, and the openings of two adjacent third incisions along the axial direction of the cutting tube are also oriented in opposite directions.

[0015] Optionally, the expansion section includes a plurality of fourth incisions, the plurality of fourth incisions are arranged along the circumference of the cutting tube, and the fourth incisions have openings open toward the proximal end of the cutting tube.

[0016] Optionally, the expansion section further includes a plurality of through holes, and the through holes are arranged inside the opening of the fourth incision.

[0017] Optionally, the curved section includes a plurality of fifth cuts, the plurality of fifth cuts are arranged along the circumference of the cutting tube and along the axial direction of the cutting tube, and the extension direction of the fifth cuts is arranged at an angle to the circumference of the cutting tube.

[0018] Optionally, the curved section also includes an outward convex cut, which is arranged at both ends of the fifth cut along its own axial direction. The outward convex cut protrudes outward from the end of the fifth cut and gradually narrows in the direction toward the fifth cut. The connecting part between the outward convex cut and the fifth cut adopts a rounded transition.

[0019] Optionally, the distance between two adjacent fifth incisions along the circumference of the cutting tube gradually increases from the distal end of the cutting tube to the proximal end of the cutting tube.

[0020] Optionally, the cutting tube further comprises a bending control cut, wherein the bending control cut is arranged between the expansion section and the bending section along the axial direction of the cutting tube, and the bending control cut is used for allowing a bending control wire to pass into or out of the interior of the cutting tube, and the bending control wire is used to drive the cutting tube to bend.

[0021] Optionally, the cutting tube further comprises an adjustment hole, wherein the adjustment hole is arranged between the expansion section and the bending section along the axial direction of the cutting tube, and the adjustment hole is used to reduce the radial stiffness of the cutting tube.

[0022] Optionally, the thickness of the cutting tube along its radial direction is 0.15 mm to 0.3 mm; and the ratio of the thickness of the cutting tube along its radial direction to the diameter of the cutting tube is 0.03 to 0.04.

[0023] In order to achieve the above object, the present invention further provides a sheath tube, comprising: an inner layer, an outer layer and the cutting tube as described above; the cutting tube is arranged between the inner layer and the outer layer along the radial direction of the sheath tube.

[0024] In order to achieve the above object, the present invention also provides a delivery system, comprising: a handle assembly and the sheath tube as described above;

[0025] The distal end of the sheath is used to cover the valve prosthesis during the delivery process;

[0026] The handle assembly is disposed at the proximal end of the sheath tube, and is used to drive the sheath tube to bend and / or drive the sheath tube to move along its own axial direction to release and / or recover the valve prosthesis.

[0027] In summary, the present invention proposes a cutting tube, a sheath tube, and a delivery system, wherein the cutting tube comprises: an expansion section and a bending section, the expansion section and the bending section are arranged along the axial direction of the cutting tube, and the expansion section is located at the distal end of the bending section; the expansion section is used to expand outward along a direction that is angled with the radial direction of the cutting tube when delivering and / or recovering a valve prosthesis; the bending section is used to bend during the delivery and / or recovery of a valve prosthesis. Compared with the prior art, the present application has the following advantages:

[0028] (1) The cutting tube includes an expansion section and a bending section. The expansion section is arranged at the distal end of the cutting tube and can expand outward in a direction at an angle to the radial direction of the cutting tube during the process of conveying and recovering the valve prosthesis, thereby realizing the recovery of the valve prosthesis. At the same time, the bending section bends during the process of conveying the valve prosthesis, so that the cutting tube has both the performance of bending and recovering the valve prosthesis, thereby improving the practicality of the cutting tube, facilitating the operation of the operator and improving the safety performance.

[0029] (2) The first incision is a hexagonal incision, so that the first incision is easier to be stretched in the radial direction of the cutting tube, thereby increasing the distal opening diameter of the cutting tube and facilitating the recovery of the valve prosthesis; the two second incisions in each second incision group are connected by a connecting incision, and the setting of the connecting incision can prevent the cutting tube from rotating around its own axis during transportation; the stress holes are located at both ends of the second incision group and are located at the same axial position as the second incisions in the second incision group. With such a configuration, the stress holes can prevent stress concentration on both sides of the second incision group during bending;

[0030] (3) The spiral cut is arranged in a coiled manner along the axial direction of the cutting tube, so that the spiral cut expands along the radial direction of the cutting tube during the process of conveying and recovering the valve prosthesis, and the distal end of the cutting tube presents a trumpet shape with a larger opening, which is more conducive to recovering the valve prosthesis; the third cut has an opening that is open along the circumference of the cutting tube. The third cuts are arranged at intervals along the circumference of the cutting tube and at intervals along the axial direction of the cutting tube. The openings of two third cuts adjacent to each other along the circumference of the cutting tube are in opposite directions, and the openings of two third cuts adjacent to each other along the axial direction of the cutting tube are also in opposite directions. With this configuration, the third cut allows the cutting tube to bend at both ends along its own axial direction, thereby improving the bending performance of the cutting tube;

[0031] (4) The convex cutouts are arranged at both ends of the fifth cutout along its own axial direction, and the convex cutouts gradually narrow in the direction toward the fifth cutout. The arrangement of the convex cutouts can avoid stress concentration, thereby avoiding local structural fracture and failure of the cutting tube, and improving the bending strength of the cutting tube; the distance between the two fifth cutouts located at the distal end of the cutting tube and adjacent to each other along the circumference of the cutting tube is smaller than the distance between the two fifth cutouts located at the proximal end of the cutting tube and adjacent to each other along the circumference of the cutting tube. With such a configuration, the cutting tube can avoid stress concentration and can withstand greater bending stress;

[0032] (5) The bending control incision is used for the bending control wire to pass into or out of the interior of the cutting tube. The bending control wire is used to drive the cutting tube to bend, so that the cutting tube can be actively bent, and the degree of bending is controllable, thereby avoiding unnecessary damage to the blood vessel during the delivery process;

[0033] (6) The adjustment hole is used to reduce the radial stiffness of the cutting tube, making it easier for the distal end of the cutting tube to expand radially outward, thereby reducing the difficulty of recovering the valve prosthesis. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 A schematic diagram of a cutting tube provided in a first embodiment of the present invention and its expanded view;

[0035] Figure 2 A partial enlarged view of a cutting tube provided in a first embodiment of the present invention;

[0036] Figure 3 A schematic diagram of a variation of the first incision provided in the first embodiment of the present invention;

[0037] Figure 4 A schematic diagram of the bending of a cutting tube provided in a first embodiment of the present invention;

[0038] Figure 5 A schematic diagram of a cutting tube and its development diagram provided for a second embodiment of the present invention;

[0039] Figure 6 A partial enlarged view of the expansion section provided in the second embodiment of the present invention;

[0040] Figure 7 A partial enlarged view of a curved section provided in a second embodiment of the present invention;

[0041] Figure 8 A schematic diagram of the bending of a cutting tube provided in a second embodiment of the present invention;

[0042] Fig. 9 A schematic diagram of a cutting tube and its expanded view provided for a third embodiment of the present invention;

[0043] Fig.10 A partial enlarged view of the expansion section provided in the third embodiment of the present invention;

[0044] Fig.11 A partial enlarged view of a curved section provided in a third embodiment of the present invention;

[0045] Fig.12 A plan view of a cut tube provided in a third embodiment of the present invention;

[0046] Fig.13 A schematic diagram of the bending of a cutting tube provided in a third embodiment of the present invention;

[0047] Fig.14 A cross-sectional view of a sheath tube provided by an embodiment of the present invention;

[0048] Fig.15 A schematic diagram of a conveying system provided by an embodiment of the present invention;

[0049] Fig.16 A schematic diagram of the positional relationship between the sheath and the valve prosthesis provided in an embodiment of the present invention;

[0050] Fig.17 A schematic diagram of a conveying system provided by an embodiment of the present invention during a conveying process;

[0051] Fig.18 A schematic diagram of the delivery system provided by an embodiment of the present invention when releasing or retrieving a valve prosthesis;

[0052] The description of each reference numeral is as follows:

[0053] 1-cutting tube; 11-expansion section; 12-bending section; 13-bending control incision; 14-adjusting hole; 111-first incision; 112-spiral incision; 113-fourth incision; 114-through hole; 121-second incision; 122-connecting incision; 123-stress hole; 124-third incision; 125-fifth incision; 126-convex incision;

[0054] 2-inner layer; 3-outer layer; 4-handle assembly; 5-valve prosthesis; 6-sheath;

[0055] X-axial direction; Y-radial direction; Z-circumferential direction. DETAILED DESCRIPTION

[0056] In order to make the purpose, advantages and features of the present invention clearer, the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. In addition, the structure shown in the drawings is often a part of the actual structure. In particular, the emphasis of each drawing is different, and sometimes different scales are used.

[0057] As used in this specification, the singular forms "one", "an" and "the" include plural objects, the term "or" is generally used to include the meaning of "and / or", the term "several" is generally used to include the meaning of "at least one", and the term "at least two" is generally used to include the meaning of "two or more". In addition, the terms "first", "second" and "third" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first", "second" and "third" may explicitly or implicitly include one or at least two of the features, "one end" and "the other end" and "proximal end" and "distal end" generally refer to two corresponding parts, which not only include the endpoints, wherein the "proximal end" generally represents the direction close to the doctor during the operation, and the "distal end" generally represents the direction close to the lesion during the operation. The terms "installed", "connected" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral body; it can be directly connected or indirectly connected through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. In addition, as used in this specification, an element disposed on another element generally only indicates that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the connection, coupling, cooperation or transmission between the two elements may be direct or indirect through an intermediate element, and it cannot be understood as indicating or implying the spatial position relationship between the two elements, that is, one element may be in any orientation such as inside, outside, above, below or on one side of another element, unless the content clearly indicates otherwise. The terms "upper", "lower", "top" and "bottom" are generally relative position relationships arranged in the direction of gravity; the terms "vertical, vertical direction" generally refer to the direction of gravity, which is generally perpendicular to the ground, and "horizontal, horizontal plane direction" generally refers to the direction parallel to the ground; for ordinary technicians in this field, the specific meanings of the above terms in this specification can be understood according to specific circumstances.

[0058] The purpose of the present invention is to provide a cutting tube, a sheath tube and a delivery system to solve the problem that the existing artificial valve delivery system cannot take into account both the recyclability and the bending coaxial performance.

[0059] The following description is given with reference to the accompanying drawings.

[0060] The inventors found that most of the existing artificial valve delivery systems can only meet the function of being recyclable, and cannot have the performance of being bendable and coaxial. It can be understood by those skilled in the art that in the process of the delivery system delivering the valve prosthesis, the valve prosthesis is covered by the distal end of the sheath, and the sheath needs to bend to adapt to the structure of different blood vessels; when the delivery system reaches the diseased valve, the sheath needs to be further bent to reach a coaxial position with the diseased valve, and the sheath is operated to move along its own axis toward the proximal end of the sheath to release the valve prosthesis; if the position of the valve prosthesis is found to be incorrect during the release process, the sheath can be operated to move along its own axis toward the distal end of the sheath to recover the valve prosthesis. At this time, the distal end of the sheath is forced to expand radially outward, and needs to withstand a large pressure to compress the valve prosthesis. Therefore, the sheath must not only take into account the flexibility of bending, but also have a certain rigidity. It should be noted that the present application only uses an artificial valve delivery system as an example, and its structure can also be applied to other components that need to be covered on the distal end of the sheath for delivery, such as stents, etc. As long as the scenario requires covering on the distal end of the sheath for delivery, the structure of the present application can be adopted.

[0061] Based on the above research, please refer to Figure 1 , Figure 5 and Fig. 9 The present invention provides a cutting tube, comprising: an expansion section 11 and a bending section 12, wherein the expansion section 11 and the bending section 12 are arranged along the axial direction X of the cutting tube 1, and the expansion section 11 is located at the distal end of the bending section 12; the expansion section 11 is used to expand outward along a direction that is angled with the radial direction Y of the cutting tube 1 when transporting and / or recovering the valve prosthesis 5; the bending section 12 is used to bend during the process of transporting and / or recovering the valve prosthesis 5. It should be noted that the cutting tube 1 can be a tubular member made of a shape memory material such as nickel-titanium alloy; the direction that is angled with the radial direction Y of the cutting tube 1 includes any value between 0° and 90°, which depends on the size of the valve prosthesis 5; the axial direction X of the cutting tube 1 is the extension direction of the cutting tube 1 (in Figure 1 , Figure 2 In the unfolded diagram, the axial direction X of the cutting tube 1 is the up-down direction); the radial direction Y of the cutting tube 1 is the radial direction of the cross section of the cutting tube 1 (in Fig.14 In the figure, only the extension direction of an axis passing through the center of the cross-section is taken as an example. Those skilled in the art should understand that the extension direction of any axis passing through the cross-section circle is the radial direction Y of the cutting tube 1); the circumferential direction Z of the cutting tube 1 is the extension direction of the outer periphery of the cutting tube 1 (in Fig.14 In the embodiment, the circumferential direction Z of the cutting tube 1 is the extending direction of the outer circumference, while in the embodiment such as Figure 1 , Figure 2In the expanded diagram, the circumferential direction Z of the cutting tube 1 is the left-right direction); the valve prosthesis 5 may also be other implants that need to be implanted in the body, such as stents. Those skilled in the art will understand that during the process of conveying the valve prosthesis 5, the expansion section 11 will be slightly expanded outward along the radial direction Y of the cutting tube 1 due to the force of the compressed valve prosthesis 5 expanding outward along the radial direction Y of the cutting tube 1; and when recovering the valve prosthesis 5, the expansion section 11 will expand outward along the direction at an angle to the radial direction Y of the cutting tube 1 to form a trumpet-shaped opening, at which time the expanded valve prosthesis 5 is retracted into the cutting tube 1 from the trumpet-shaped opening; at the same time, the trumpet-shaped opening compresses the expanded valve prosthesis 5 so that it is re-wrapped on the distal end of the cutting tube 1.

[0062] Configured in this way, the cutting tube 1 includes an expansion section 11 and a bending section 12. The expansion section 11 is arranged at the distal end of the cutting tube 1, and can expand outward along the radial direction Y of the cutting tube 1 during the process of transporting and recovering the valve prosthesis 5, thereby overcoming the force of the valve prosthesis 5 expanding outward and realizing the transport and recovery of the valve prosthesis 5; at the same time, the bending section 12 can bend during the process of transporting the valve prosthesis 5, so that the cutting tube 1 has the performance of bending and recovering the valve prosthesis 5, thereby improving the practicability of the cutting tube, facilitating the operator's operation, and also improving the safety performance.

[0063] As an optional embodiment, please refer to Figure 2 and Figure 3 , the expansion section 11 includes a grid unit, and the grid unit is formed by a plurality of first incisions 111, which are sequentially connected along the axial direction X of the cutting tube 1 and the circumferential direction Z of the cutting tube 1. Among them, the plurality of first incisions 111 are sequentially connected along the circumferential direction Z of the cutting tube 1 to form a row, and are sequentially connected along the axial direction X of the cutting tube 1 to form a column, and finally form a grid unit. As a preferred embodiment, the first incision 111 is a hexagonal incision. With such a configuration, in the process of releasing the valve prosthesis 5 or recovering the valve prosthesis 5, the distal opening of the cutting tube 1 presents a trumpet shape under the extrusion of the valve prosthesis 5, and the hexagonal first incision 111 is easier to expand along the circumferential direction Z of the cutting tube 1, so that the valve prosthesis 5 is easier to be released or recovered. Of course, in some other embodiments, the cross-sectional shape of the first incision 111 can also be other easily stretched shapes, such as a circle, an ellipse, a parallelogram, etc.; two adjacent rows of first incisions 111 can also be distributed evenly or irregularly along the axial direction X of the cutting tube 1.

[0064] Please refer to Figures 1 to 4, the bending section 12 includes a plurality of second incisions 121, and the plurality of second incisions 121 are arranged along the axial direction X of the cutting tube 1, and along the circumferential direction Z of the cutting tube 1, and the extension direction of the second incisions 121 is arranged at an angle to the circumferential direction Z of the cutting tube 1; at least two second incisions 121 adjacent to each other along the circumferential direction Z of the cutting tube 1 form a second incision group. It should be noted that, in the present embodiment, the second incision 121 is a long strip incision, and the width of the incision gradually narrows from one end to the other end. Those skilled in the art can understand that there are reinforcing ribs between the two second incision groups arranged along the circumferential direction Z of the cutting tube 1, and the reinforcing ribs can withstand axial tension or pressure, further improving the stiffness of the cutting tube 1 (stiffness is the ability of a material to resist elastic deformation when subjected to force); at the same time, the reinforcing ribs can also control the bending direction of the cutting tube 1, thereby improving the bending performance of the cutting tube 1. Figure 1 to Figure 2 as well as Figure 4 In the illustrated example, the curved section 12 has four rows of second incisions 121, and two adjacent rows of second incisions 121 form a second incision group. In other embodiments, the curved section 12 may also have six rows, eight rows or even more rows of second incisions 121, and the second incision group may also include three or more rows of adjacent second incisions 121. The second incisions 121 may also be incisions of other shapes, such as a circle, a parallelogram or other irregular shapes.

[0065] Furthermore, the curved section 12 further includes a plurality of connecting incisions 122, and the second incisions 121 in each second incision group are connected via the connecting incisions 122. With such a configuration, the connecting incisions 122 can prevent the cutting tube 1 from being twisted due to the restriction of the shape of the blood vessel when the curved section 12 is bent, thereby affecting the release or recovery of the valve prosthesis 5 and causing safety hazards.

[0066] Furthermore, the curved section 12 further includes a plurality of stress holes 123, which are located at both ends of the second incision group along the circumferential direction Z of the cutting tube 1 and are located at the same axial position as the second incision 121 in the second incision group. It should be noted that the stress holes 123 are arranged at both ends of the second incision group along the circumferential direction Z of the cutting tube 1, that is, the stress holes 123 need to be arranged at one end of the second incision 121 away from the connecting incision 122; Figure 2In the illustrated example, the second incisions 121 in the same second incision group are gradually narrowed from the middle to both ends, and the stress holes 123 are respectively arranged at the narrowed ends of the second incisions 121; in some other embodiments, the second incisions 121 in the same second incision group can also be gradually widened from the middle to both ends, and the stress holes 123 need to be arranged at the widened ends of the second incisions 121; the second incisions 121 in the same second incision group can also be irregularly shaped incisions, in which case the stress holes 123 should be arranged at one end of the second incision 121 away from the connecting incision 122. With such a configuration, the stress holes 123 can avoid stress concentration on both sides of the second incision group when the bending section 12 is bent, thereby affecting the rigidity of the entire cutting tube 1. In some other alternative embodiments, the stress holes 123 can also be square holes, triangular holes, elliptical holes or holes of other irregular shapes.

[0067] As another example, please refer to Figures 5 to 7 The expansion section 11 includes a spiral unit, which is formed by a spiral cut 112 winding along the axial direction X of the cutting tube 1. Optionally, the cutting pitch of the spiral cut 112 is 0.05 mm to 0.1 mm, and the number of spiral turns of the spiral cut 112 is 15 to 25. Those skilled in the art can understand that Figure 6 In the example shown, since there is no rib constraint on the axial direction X of the cutting tube 1, during the process of releasing the valve prosthesis 5 or recovering the valve prosthesis 5, the spiral cut 112 can expand outward in a direction at an angle to the radial direction Y of the cutting tube 1, thereby forming a trumpet shape with a larger opening, making the valve prosthesis 5 easier to release or recover.

[0068] Please refer to Figures 5 to 8 The curved section 12 includes a plurality of third cutouts 124, and the third cutouts 124 have openings that are open toward the circumferential direction Z of the cutting tube 1. The plurality of third cutouts 124 are arranged along the circumferential direction Z of the cutting tube 1, and along the axial direction X of the cutting tube 1. The openings of two third cutouts 124 that are adjacent along the circumferential direction Z of the cutting tube 1 are oriented in opposite directions, and the openings of two third cutouts 124 that are adjacent along the axial direction X of the cutting tube 1 are also oriented in opposite directions. As an optional embodiment, the axial X distance between two third cutouts 124 that are adjacent along the axial direction X of the cutting tube 1 is 0.25 mm to 0.3 mm; the distance between two third cutouts 124 that are adjacent along the circumferential direction Z of the cutting tube 1 is 0.55 mm to 0.65 mm. Figure 7In the illustrated example, the openings of two third incisions 124 adjacent along the circumferential direction Z of the cutting tube 1 can be arranged to face each other or to face away from each other; at the same time, the openings of two third incisions 124 adjacent along the axial direction X of the cutting tube 1 can also be arranged to face each other or to face away from each other. Such a configuration not only enhances the bending performance of the bending section 12, but also enables the bending section 12 to meet the rigidity requirements, thereby improving the safety performance during use. It should be noted that, in the present embodiment, the third incision 124 is a horizontally placed U-shaped incision, and the U-shaped incision has two oppositely arranged side grooves and an arc-shaped groove at one end of the two side grooves. The opening direction of the U-shaped incision depends on the extension direction of the side grooves. Figure 7 In the illustrated example, the side grooves extend along the circumferential direction Z of the cutting tube 1, so the openings of the third cutouts 124 are arranged toward the circumferential direction Z of the cutting tube 1; the curved section 12 has two rows of third cutouts 124. In other optional embodiments, the openings of the third cutouts 124 may also be arranged toward a direction that forms an angle with the circumferential direction of the cutting tube 1; the third cutouts 124 may also be arc-shaped cutouts or cutouts of other irregular shapes, and the curved section 12 may also have three or more rows of third cutouts 124.

[0069] In another optional embodiment, please refer to Figures 9 and 10 The expansion section 11 includes a plurality of fourth cutouts 113, which are arranged along the circumferential direction Z of the cutting tube 1, and the fourth cutouts 113 have openings that open toward the proximal end of the cutting tube 1. Further, the expansion section 11 also includes a plurality of through holes 114, which are arranged inside the openings of the fourth cutouts 113. Fig.10 In the illustrated example, the fourth incision 113 is a pressure rod structure composed of an inverted U-shaped incision, and the arrangement of the arc-shaped edge at the top ensures sufficient stability of the expansion section 11 when the valve prosthesis 5 is recovered, avoiding fracture, breakage, etc.; the through hole 114 is a hollow structure formed by a long strip of through holes. With such a configuration, during the process of recovering the valve prosthesis 5, the fourth incision 113 and the through hole 114 can present a trumpet-shaped configuration with a large opening, while also providing good pressure resistance. Therefore, when the valve prosthesis 5 is recovered and subjected to a large force, the pressure rod will not become unstable.

[0070] Please refer to Figures 9 to 13 The curved section 12 includes a plurality of fifth cutouts 125, which are arranged along the circumferential direction Z of the cutting tube 1 and along the axial direction X of the cutting tube 1. The extension direction of the fifth cutouts 125 is set at an angle to the circumferential direction Z of the cutting tube 1. Fig.11In the illustrated example, the fifth incision 125 is a rectangular incision, and the length of the fifth incision 125 along the circumferential direction Z of the cutting tube 1 is 90 mm to 120 mm; the width of the fifth incision 125 along the axial direction X of the cutting tube 1 is 0.1 mm to 0.4 mm; the angle between the extension direction of the fifth incision 125 and the circumferential direction Z of the incision body is 0° to 4°. With such a configuration, the setting of the angle enables the bending section 12 to better adapt to the human aortic arch during the bending process. In other embodiments, the fifth incision 125 can also be an arc incision, a parallelogram incision, or other irregular shapes.

[0071] Furthermore, the curved section 12 further includes an outward convex cutout 126, which is disposed at both ends of the fifth cutout 125 along its own axial direction X. The outward convex cutout 126 protrudes outward from the end of the fifth cutout 125 and gradually narrows in the direction toward the fifth cutout 125. The connection portion between the outward convex cutout 126 and the fifth cutout 125 adopts a rounded transition. Fig.11 The convex incision 126 is a trapezoidal incision, and is connected to the fifth incision 125 with a fillet of 0.03mm to 0.06mm on one side close to the end of the fifth incision 125. With such a configuration, during the bending process of the bending section 12 under force, the convex incision 126 can avoid stress concentration at both ends of the fifth incision 125. Excessive stress concentration will cause the local structure of the cutting tube 1 to break and fail, thereby affecting the patient's treatment effect. At the same time, the broken cutting tube 1 is also likely to cause unnecessary damage to the patient's blood vessels.

[0072] Please refer to Fig.12 The distance between two adjacent fifth incisions 125 along the circumferential direction Z of the cutting tube 1 gradually increases from the distal end of the cutting tube 1 to the proximal end of the cutting tube 1. Fig.12 For example, there is a long rib between two adjacent fifth incisions 125 along the circumferential direction Z of the cutting tube 1, and the long rib has a straight section and a gradient section, the straight section is the first 4 / 5 of the length of the long rib from the proximal end of the cutting tube 1 along the axial direction X of the cutting tube 1, and the gradient section is the last 1 / 5 of the length of the long rib from the proximal end of the cutting tube 1 along the axial direction X of the cutting tube 1, wherein the width of the straight section along the circumferential direction Z of the cutting tube 1 is a fixed value, optionally, the width of the straight section along the circumferential direction Z of the cutting tube 1 may be 0.5 mm to 0.9 mm, and the width of the long rib located in the straight section along the circumferential direction Z of the cutting tube 1 is 1.8 to 2.0 times the width of the long rib located at the distal end of the cutting tube 1 along the circumferential direction Z of the cutting tube 1. With such configuration, the long ribs can withstand axial force. At the same time, since the proximal end of the cutting tube 1 is subjected to a large shear force during the bending process of the bending section 12, the setting of the gradient section can withstand a large bending stress, thereby avoiding stress concentration in the long ribs and further improving the safety of the cutting tube 1 during use.

[0073] Please refer to Fig.10 The cutting tube 1 also includes a bending control cutout 13, which is arranged between the expansion section 11 and the bending section 12 along the axial direction X of the cutting tube 1. The bending control cutout 13 is used for the bending control wire to pass into or out of the interior of the cutting tube 1, and the bending control wire is used to drive the cutting tube 1 to bend. Fig.10 For example, the bending control incision 13 is a rounded rectangular incision, and the two bending control incisions 13 are located at the same axial position of the cutting tube 1. The bending control wire passes through the interior of the cutting tube 1 from one of the bending control incisions 13, passes through the interior of the cutting tube 1 from the other bending control incision 13, and is connected to the handle assembly 4. Different from other embodiments, the setting of the bending control wire and the bending control incision 13 enables the bending section 12 to be actively bent to avoid damage to the inner wall of the blood vessel; while other bending sections 12 that are not provided with the bending control wire and the bending control incision 13 are usually passively bent due to the limitation of the shape of the blood vessel, which is easy to cause abrasions to the inner wall of the blood vessel. Of course, in other embodiments, the bending control incisions 13 can also be arranged in a staggered manner along the circumferential direction Z of the cutting tube 1.

[0074] Furthermore, the cutting tube 1 further comprises an adjustment hole 14, which is arranged between the expansion section 11 and the bending section 12 along the axial direction X of the cutting tube 1, and the adjustment hole 14 is used to reduce the radial stiffness of the cutting tube 1. Fig.10 For example, a plurality of adjustment holes 14 are provided at both ends of the bending control incision 13. The adjustment holes 14 are circular holes. With such a configuration, the adjustment holes 14 can reduce the radial stiffness of the cutting tube 1, thereby reducing the difficulty of recovering the valve prosthesis 5, and further improving the practicability of the cutting tube 1.

[0075] In an optional embodiment, the thickness of the cutting tube 1 along its own radial direction Y is 0.15mm to 0.3mm; the ratio of the thickness of the cutting tube 1 along its own radial direction Y to the diameter of the cutting tube 1 is 0.03 to 0.04. With such a configuration, when the thickness of the cutting tube 1 is less than the lower limit, the rigidity of the cutting tube 1 cannot be guaranteed, which may easily cause safety hazards; when the thickness of the cutting tube 1 is greater than the upper limit, the overall thickness of the sheath tube will increase, which is not conducive to the delivery of the valve prosthesis 5 in the blood vessel, and also reduces the bending performance of the cutting tube. It can be understood by those skilled in the art that the cutting tube 1 is a hollow tube, and its diameter is the distance between the outer tube walls at the two symmetrical ends. Those skilled in the art can adjust the thickness of the cutting tube 1 and the ratio of the thickness to the diameter of the cutting tube 1 according to actual conditions.

[0076] Please refer to Fig.14The present invention also provides a sheath tube, comprising: an inner layer 2, an outer layer 3 and the cutting tube as described above; the cutting tube 1 is arranged between the inner layer 2 and the outer layer 3 along the radial direction Y of the sheath tube 6. It should be noted that in the present embodiment, the inner layer 2 is made of PTFE (polytetrafluoroethylene) material with lubricating properties, which reduces the friction between the valve prosthesis 5 and the inner layer 2 during the recovery of the valve prosthesis 5, thereby reducing the resistance to recovery; the cutting tube 1 is a nickel-titanium alloy tube, and the cutting tube is made by laser cutting or other processes; the outer layer 3 is made of a polymer material (such as TSPU, Pebax3533, etc.), which has good lubricity and can reduce the friction between the outer layer 3 and the arterial blood vessels during the delivery of the valve prosthesis 5, thereby reducing the resistance during the delivery process. Those skilled in the art can flexibly configure the materials and molding methods of the inner layer 2, the cutting tube 1 and the outer layer 3 according to actual conditions, and the present embodiment is not limited to this.

[0077] Please refer to Figures 15 to 18 The present invention also provides a delivery system, including: a handle assembly 4 and the sheath 6 as described above; the distal end of the sheath 6 is used to cover the valve prosthesis 5 during the delivery process; the handle assembly 4 is arranged at the proximal end of the sheath 6, and the handle assembly 4 is used to drive the sheath 6 to bend and / or drive the sheath 6 to move along its own axial direction X. It can be understood by those skilled in the art that the valve prosthesis 5 can also be other implants that need to be implanted in the body, such as stents. In an alternative embodiment, the valve prosthesis 5 is accommodated at the distal end of the sheath 6, which is equivalent to the expansion section 11 (such as Fig.16 As shown in FIG. 1 , the operator places the valve prosthesis 5 at the distal end of the sheath tube 6 before the operation. At this time, the expansion section 11 is slightly expanded to limit the expansion of the valve prosthesis 5 in the radial direction Y. During the operation, the sheath tube 6 enters the target position (in this embodiment, it can be the relevant diseased valve) from the arterial puncture port. The operator operates the handle assembly 4 to bend the bending section 12 of the sheath tube 6 so that the bent sheath tube 6 and the target position are on the same axis (as shown in FIG. 1 ). Fig.17 At this time, the operator operates the handle assembly 4 to move the distal end of the sheath tube 6 along its own axial direction X toward the proximal end, and the valve prosthesis 5 gradually expands from the compressed state to the natural state until the valve prosthesis 5 is completely released (as shown in FIG. Fig.18 As shown); if in the process of releasing the valve prosthesis 5, it is found that the release position of the valve prosthesis 5 is offset, jumped or has other position inaccuracies, the handle assembly 4 can be operated to move the distal end of the sheath 6 along its own axial direction X away from the proximal end, the distal end of the sheath 6 is subjected to pressure, the opening is trumpet-shaped, and the expanded valve prosthesis 5 is recovered into the sheath 6 at the distal end of the sheath 6 and is compressed by the side wall of the sheath 6 until it is completely recovered into the sheath 6.

[0078] In summary, in the cutting tube, sheath tube and delivery system provided in the embodiments of the present invention, the cutting tube includes: an expansion section and a bending section, the expansion section and the bending section are arranged along the axial direction of the cutting tube, and the expansion section is located at the distal end of the bending section; the expansion section is used to expand radially outward along the cutting tube when delivering and / or recovering the valve prosthesis; the bending section is used to bend during the process of delivering and / or recovering the valve prosthesis.

[0079] With such configuration, the cutting tube includes an expansion section and a bending section. The expansion section is arranged at the distal end of the cutting tube, and can expand radially outward along the cutting tube during the process of conveying and recovering the valve prosthesis, thereby realizing the recovery of the valve prosthesis. Meanwhile, the bending section bends during the process of conveying the valve prosthesis, so that the cutting tube has both the performance of bending and the performance of recovering the valve prosthesis, thereby improving the practicality of the cutting tube, facilitating the operation of the operator, and also improving the safety performance.

[0080] Furthermore, the first incision is a hexagonal incision, so that the first incision is easier to be stretched in the radial direction of the cutting tube, thereby increasing the distal opening diameter of the cutting tube and facilitating the recovery of the valve prosthesis; the two second incisions in each second incision group are connected by a connecting incision, and the setting of the connecting incision can prevent the cutting tube from rotating around its own axis during transportation; the stress holes are located at both ends of the second incision group and are located at the same axial position as the second incisions in the second incision group. With such a configuration, the stress holes can prevent stress concentration from occurring on both sides of the second incision group during bending;

[0081] Furthermore, the spiral incision is arranged in a coiled manner along the axial direction of the cutting tube, so that the spiral incision expands along the radial direction of the cutting tube during the process of conveying and recovering the valve prosthesis, and the distal end of the cutting tube presents a trumpet shape with a larger opening, which is more conducive to recovering the valve prosthesis; the third incision has an opening that is open along the circumference of the cutting tube, and the third incisions are arranged at intervals along the circumference of the cutting tube and at intervals along the axial direction of the cutting tube. The openings of two third incisions adjacent to each other along the circumference of the cutting tube are in opposite directions, and the openings of two third incisions adjacent to each other along the axial direction of the cutting tube are also in opposite directions. With this configuration, the third incision allows the cutting tube to bend at both ends along its own axial direction, thereby improving the bending performance of the cutting tube;

[0082] Furthermore, the convex cutouts are arranged at both ends of the fifth cutout along its own axial direction, and the convex cutouts gradually narrow in the direction toward the fifth cutout. The arrangement of the convex cutouts can avoid the stress concentration phenomenon, thereby avoiding the local structural fracture failure of the cutting tube, and improving the bending strength of the cutting tube; the distance between the two fifth cutouts adjacent to each other along the circumference of the cutting tube at the distal end of the cutting tube is smaller than the distance between the two fifth cutouts adjacent to each other along the circumference of the cutting tube at the proximal end of the cutting tube. With such a configuration, the cutting tube can avoid the stress concentration phenomenon and can withstand greater bending stress;

[0083] Furthermore, the bending control incision is used for the bending control wire to pass into or out of the interior of the cutting tube, and the bending control wire is used to drive the cutting tube to bend, so that the cutting tube can be actively bent, and the degree of bending is controllable, thereby avoiding unnecessary damage to the blood vessel during the delivery process;

[0084] Furthermore, the adjustment hole is used to reduce the radial rigidity of the cutting tube, so that the distal end of the cutting tube is easier to expand radially outward, thereby reducing the difficulty of recovering the valve prosthesis.

[0085] The above description is only a description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes or modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the scope of protection of the claims.

Claims

1. A cutting tube, characterized in that: It comprises an expansion section and a bending section, wherein the expansion section and the bending section are arranged along the axial direction of the cutting tube, and the expansion section is located at the distal end of the bending section; The expansion section is used to expand outwardly along a direction that is angled with the radial direction of the cutting tube when the valve prosthesis is being transported and / or recovered; the bending section is used to bend during the process of transporting and / or recovering the valve prosthesis.

2. The cutting tube according to claim 1, characterized in that The expansion section includes a grid unit, and the grid unit is formed by connecting a plurality of first cuts in sequence along the axial direction of the cutting tube and the circumferential direction of the cutting tube.

3. The cutting tube according to claim 1, characterized in that The curved section includes a plurality of second cutouts, which are arranged along the axial direction of the cutting tube and along the circumferential direction of the cutting tube, and the extension direction of the second cutouts is arranged at an angle to the circumferential direction of the cutting tube.

4. The cutting tube according to claim 3, characterized in that The bending section further comprises a plurality of connecting cuts, wherein at least two second cuts adjacent to each other along the circumference of the cutting tube form a second cut group, and the second cuts in each second cut group are connected via the connecting cuts.

5. The cutting tube according to claim 4, characterized in that The bending section further includes a plurality of stress holes, which are located at two ends of the second incision group along the circumferential direction of the cutting tube and are located at the same axial position as the second incision in the second incision group.

6. The cutting tube according to claim 1, characterized in that The expansion section includes a spiral unit, and the spiral unit is formed by a spiral cut coiled along the axial direction of the cutting tube.

7. The cutting tube according to claim 1, characterized in that The curved section includes a plurality of third incisions, each of which has an opening that is open toward the circumference of the cutting tube. The plurality of third incisions are arranged along the circumference of the cutting tube and along the axial direction of the cutting tube. The openings of two third incisions that are adjacent to each other along the circumference of the cutting tube are oriented in opposite directions, and the openings of two third incisions that are adjacent to each other along the axial direction of the cutting tube are also oriented in opposite directions.

8. The cutting tube according to claim 1, characterized in that The expansion section includes a plurality of fourth cutouts arranged along the circumference of the cutting tube, and the fourth cutouts have openings opening toward the proximal end of the cutting tube.

9. The cutting tube according to claim 8, characterized in that The expansion section further includes a plurality of through holes, and the through holes are arranged inside the opening of the fourth incision.

10. The cutting tube according to claim 1, characterized in that The curved section comprises a plurality of fifth cutouts, the plurality of fifth cutouts are arranged along the circumference of the cutting tube and along the axial direction of the cutting tube, and the extension direction of the fifth cutouts is arranged at an angle to the circumference of the cutting tube.

11. The cutting tube according to claim 10, characterized in that The curved section also includes an outward convex cut, which is arranged at both ends of the fifth cut along its own axial direction. The outward convex cut protrudes outward from the end of the fifth cut and gradually narrows in the direction toward the fifth cut. The connecting part between the outward convex cut and the fifth cut adopts a rounded transition.

12. The cutting tube according to claim 10, characterized in that The distance between two adjacent fifth incisions along the circumferential direction of the cutting tube gradually increases from the distal end of the cutting tube to the proximal end of the cutting tube.

13. The cutting tube according to claim 1, characterized in that The cutting tube also includes a bending control cutout, which is arranged between the expansion section and the bending section along the axial direction of the cutting tube. The bending control cutout is used for allowing a bending control wire to pass into or out of the interior of the cutting tube, and the bending control wire is used to drive the cutting tube to bend.

14. The cutting tube according to claim 1, wherein: The cutting tube further comprises an adjustment hole, wherein the adjustment hole is arranged between the expansion section and the bending section along the axial direction of the cutting tube, and the adjustment hole is used to reduce the radial rigidity of the cutting tube.

15. The cutting tube according to claim 1, wherein: The thickness of the cutting tube along its radial direction is 0.15 mm to 0.3 mm; the ratio of the thickness of the cutting tube along its radial direction to the diameter of the cutting tube is 0.03 to 0.

04.

16. A sheath tube, characterized in that: include: An inner layer, an outer layer, and a cutting tube as claimed in any one of claims 1 to 16; The cutting tube is arranged between the inner layer and the outer layer along the radial direction of the sheath tube.

17. A conveying system, characterized in that: comprising a handle assembly and a sheath as claimed in claim 16; The distal end of the sheath is used to cover the valve prosthesis during the delivery process; The handle assembly is disposed at the proximal end of the sheath tube, and is used to drive the sheath tube to bend and / or drive the sheath tube to move along its own axial direction to release and / or recover the valve prosthesis.

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