Transfemoral Valve Delivery Device

Abstract

The present invention discloses a trans-femoral valve delivery device, which includes an inner core tube assembly, an inner sheath tube assembly, and an outer sheath tube assembly. The inner core tube assembly has an inner core tube that is disposed inside the inner sheath tube assembly. A spiral elastic member is sleeved on the outer periphery of the distal end of the inner core tube. The spiral elastic member successively includes a head section, a distal transition section, a support section, a proximal transition section, and a tail section from the distal end to the proximal end; the pitch t of the support section 支 is 0; the pitch t of the distal transition section 远 : the pitch t of the proximal transition section 近 : the pitch t of the tail section 尾 are respectively 2.5 to 3.5 times, preferably 1.3 to 2 times (more preferably 1.2 to 3 times) and 0.8 to 1.2 times the pitch t of the head section 头 . The spiral of the middle support section is arranged in the densest form, the head section and the tail section are slightly denser, and the spirals of the distal transition section and the proximal transition section are arranged in a relatively sparse manner. In this way, when the elastic member has a certain supporting force, it will not cause the delivery to fail due to the excessive bending of the head section and the tail section, and can just reach a balanced state between support and bending.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a transfemoral valve delivery device. Background Art

[0002] With the extension of human lifespan and the entry into an aging society, aortic valve disease has become one of the increasingly common valve diseases. In Western developed countries, the incidence of calcific aortic stenosis ranks second only to hypertension and coronary heart disease, and has become the primary cause of valve replacement in the elderly. For a long time, surgical aortic replacement has been the main treatment method for symptomatic aortic stenosis. However, due to the large trauma of traditional surgical operations, the need for extracorporeal circulation, and the high surgical risk, a large number of patients give up surgical treatment due to fear of surgery such as advanced age, poor ventricular function, and severe complications.

[0003] Transcatheter aortic valve replacement (TAVR) is a new minimally invasive valve replacement technology developed in recent years, bringing good news to those patients who are not suitable for traditional surgical treatment. During the operation, it is necessary to puncture through the femoral artery or femoral vein, and then bend around the aortic arch to reach the aortic valve. However, due to the vessel diameter and complex vessel shape, the currently disclosed technologies are either difficult to achieve the required curvature, or the outer sheath tube is not hard enough, with a large friction with the blood vessel and is not easy to deliver. Moreover, the outer diameter of the outer sheath tube of the delivery device in the prior art is relatively large, and it will cause greater damage to the patient's blood vessel during the reciprocating movement of delivery, retraction, and even position adjustment. Summary of the Invention

[0004] Aiming at the technical problem that the distal outer tube of the delivery sheath tube in the prior art is not easy to bend around the aortic arch to reach the aortic valve, the purpose of the present invention is to provide a transfemoral valve delivery device.

[0005] The transfemoral valve delivery device of the present invention includes:

[0006] An inner core tube assembly;

[0007] An inner sheath tube assembly, which is sleeved outside the inner core tube assembly;

[0008] An outer sheath tube assembly, which can be sleeved outside the inner sheath tube assembly;

[0009] The inner core tube assembly has an inner core tube, which is sleeved inside the inner sheath tube assembly. It is characterized in that a spiral elastic member is sleeved on the outer periphery of the distal end of the inner core tube. The spiral elastic member is successively a head section, a far transition section, a support section, a near transition section, and a tail section from the distal end to the proximal end;

[0010] The pitch t of the support section 支 is 0;

[0011] The pitch t of the far transition section远 is the pitch t of the head section 头 2.5 to 3.5 times, preferably 2.8 to 3.2 times, more preferably 3 times;

[0012] The pitch t of the near transition section 近 is the pitch t of the head section 头 1.2 to 3 times, preferably 1.3 to 2 times;

[0013] The pitch t of the tail section 尾 is the pitch t of the head section 头 0.8 to 1.2 times, preferably 1 time.

[0014] In a preferred embodiment of the present invention,

[0015] The helical length H of the support section 支 is the helical length H of the head section 头 3 to 6 times;

[0016] The helical length H of the far transition section 远 is the helical length H of the head section 头 1 to 2 times;

[0017] The helical length H of the near transition section 近 is the helical length H of the head section 头 2 to 5 times and less than the helical length H of the support section 支 ;

[0018] The helical length H of the tail section 尾 is the helical length H of the head section 头 0.8 to 1.2 times, preferably 1 time.

[0019] In a preferred embodiment of the present invention,

[0020] The screw diameter D of the support section 支 is equal to the screw diameter D of the far transition section 远 , greater than the screw diameter D of the head section 头 , the D 头 gradually decreases along the head section from the proximal end to the distal end;

[0021] The screw diameter D of the support section 支 is equal to the screw diameter D of the near transition section 近 , greater than the screw diameter D of the tail section 尾 , the D 尾 gradually decreases along the tail section from the distal end to the proximal end.

[0022] The inner core tube assembly further has:

[0023] A push tip, the distal end of the push tip is sealingly connected to the distal end of the balloon of the inner sheath tube assembly and fixedly connected to the distal end of the inner core tube, and the proximal end of the push tip is fixedly connected to the head section of the helical elastic member;

[0024] A developing ring, fixed on the inner core tube and close to the push tip.

[0025] The push tip has a conical head and a fixing seat fixed at the bottom of the conical head. The push tip communicates with the distal end of the inner core tube through the fixing seat. One end of the fixing seat facing the inner core tube is provided with a squeezable flared opening, and a plurality of V-shaped slots are provided on the periphery of the flared opening. The conical head is sealingly connected to the distal end of the balloon of the inner sheath tube assembly.

[0026] The head section of the helical elastic member is fixedly connected to the outer periphery of the inner core tube through the proximal end of a push tip, the tail section of the helical elastic member is fixedly connected to the outer periphery of the inner core tube through a conical fixing ring, the middle part of the helical elastic member can move relative to the inner core tube, and the elasticity of the middle part of the helical elastic member is greater than that of both ends.

[0027] In a preferred embodiment of the present invention,

[0028] The inner sheath tube assembly includes an inner tube disposed through the proximal end of the inner core tube assembly;

[0029] The inner wall of the inner tube has at least two guide grooves extending axially in a coiled manner, and the at least two guide grooves have several cross-confluence points.

[0030] In a preferred embodiment of the present invention, the inner sheath tube assembly has:

[0031] A balloon, disposed through the distal end of the inner core tube assembly, and the helical elastic member is located inside the balloon;

[0032] A connecting tube, its distal end is connected to the proximal end of the balloon and is disposed through the inner core tube assembly;

[0033] The inner tube, its distal end is connected to the proximal end of the connecting tube and is disposed through the proximal end of the inner core tube assembly.

[0034] In a preferred embodiment of the present invention,

[0035] The outer sheath tube assembly includes:

[0036] An outer tube, which can be disposed through the outer of the inner sheath tube assembly;

[0037] A push head, connected to the distal end of the outer tube.

[0038] Wherein,

[0039] The outer tube includes a distal outer tube in the axial direction, and the interior of the distal outer tube has the following radial structure:

[0040] A plurality of first hollow grooves arranged in parallel and spaced apart;

[0041] A plurality of second hollow grooves arranged in parallel and spaced apart, which are spaced apart and staggered relative to the first hollow grooves;

[0042] Wherein, along the axial direction of the distal outer tube from the proximal end to the distal end, the arrangement density of the first hollow grooves and the second hollow grooves increases step by step.

[0043] Wherein, along the axial direction of the distal outer tube from the proximal end to the distal end, the widths of the first hollow groove and the second hollow groove decrease in sections.

[0044] In a preferred embodiment of the present invention,

[0045] The distal outer tube includes, radially from outside to inside, a distal first elastic layer, a distal second elastic layer and a distal third elastic layer;

[0046] The distal second elastic layer has a first half side wall and a second half side wall, and the first half side wall and the second half side wall together form the entire distal second elastic layer;

[0047] The first hollow groove runs through the entire radial direction of the first half side wall and extends all the way to the second half side wall;

[0048] The second hollow groove runs through the second half side wall in a radial direction.

[0049] in,

[0050] The first hollow groove runs through the entire radial direction of the first half side wall and extends all the way to the second half side wall, so that the angle corresponding to the arc formed by the cross section of the first hollow groove is 180-330°;

[0051] The second hollow groove runs through the second half side wall in a radial direction, and an angle corresponding to an arc formed by a cross section of the second hollow groove is no greater than 180°.

[0052] Wherein, the width of the first hollow groove is greater than the width of the second hollow groove.

[0053] In a preferred embodiment of the present invention, the distal second elastic layer is a corrugated pipe layer. The corrugated pipe layer successively has a proximal corrugated pipe, a middle corrugated pipe, and a distal corrugated pipe along the axial direction from the proximal end to the distal end. The arrangement density of the first hollow slots and the second hollow slots on the proximal corrugated pipe is less than that of the first hollow slots and the second hollow slots on the middle corrugated pipe, and the arrangement density of the first hollow slots and the second hollow slots on the middle corrugated pipe is less than that of the first hollow slots and the second hollow slots on the distal corrugated pipe.

[0054] In a preferred embodiment of the present invention, the distal second elastic layer is a corrugated pipe layer. The corrugated pipe layer successively has a proximal corrugated pipe, a middle corrugated pipe, and a distal corrugated pipe along the axial direction from the proximal end to the distal end. The widths of the first hollow slots and the second hollow slots on the proximal corrugated pipe are respectively greater than those of the first hollow slots and the second hollow slots on the middle corrugated pipe, and the widths of the first hollow slots and the second hollow slots on the middle corrugated pipe are respectively greater than those of the first hollow slots and the second hollow slots on the distal corrugated pipe.

[0055] Wherein, the arrangement density of the first hollow slots and the second hollow slots on the same corrugated pipe is the same from the proximal end to the distal end; or, the arrangement density of the first hollow slots and the second hollow slots on the same corrugated pipe gradually increases from the proximal end to the distal end.

[0056] Wherein, the widths of the first hollow slots and the second hollow slots on the same corrugated pipe are the same from the proximal end to the distal end; or, the widths of the first hollow slots and the second hollow slots on the same corrugated pipe gradually decrease from the proximal end to the distal end.

[0057] Wherein, the outer sheath tube assembly includes: a bending adjustment wire, which is hiddenly arranged in the side wall of the outer tube along the axial direction of the outer tube. The distal end of the bending adjustment wire is fixed on the distal end of the distal outer tube, and the proximal end of the bending adjustment wire is led out from near the proximal end of the proximal outer tube and can be controlled by the operation handle of the trans-femoral artery valve delivery device.

[0058] The outer tube includes a proximal outer tube and the distal outer tube that are in communication with each other along the axial direction from the proximal end to the distal end.

[0059] In a preferred embodiment of the present invention,

[0060] The proximal outer tube successively includes, from outside to inside in the radial direction: a proximal first elastic layer, a proximal second elastic layer, and a proximal third elastic layer. The elasticity of the proximal second elastic layer is not greater than that of the proximal first elastic layer and the proximal third elastic layer.

[0061] Wherein, the elasticity of the distal second elastic layer is greater than that of the proximal second elastic layer.

[0062] In a preferred embodiment of the present invention,

[0063] The distal end of the distal outer tube has a wire fixing ring, and the distal end of the bending adjustment wire is fixed to the wire fixing ring of the distal outer tube.

[0064] Wherein,

[0065] The outer side wall of the wire fixing ring has an axially extending wire receiving cavity, the outer side wall of the proximal second elastic layer has an axially extending proximal wire cavity, and the outer side wall of the distal second elastic layer has an axially extending distal wire cavity;

[0066] The wire fixing ring is fixedly connected to the distal end of the distal second elastic layer and is clamped between the distal ends of the distal first elastic layer and the distal third elastic layer; the wire receiving cavity on the wire fixing ring is in communication with the distal wire cavity and the proximal wire cavity; the distal end of the bending adjustment wire is fixed to the wire fixing ring and sequentially passes through the wire receiving cavity, the distal wire cavity and the proximal wire cavity, and the proximal end of the bending adjustment wire is led out from near the proximal end of the proximal outer tube and can be controlled by the operating handle of the transcatheter aortic valve delivery device.

[0067] Wherein, the proximal first elastic layer of the proximal outer tube has an opening point near the proximal end, and the proximal end of the bending adjustment wire is led out from the opening point.

[0068] Wherein, the wire receiving cavity of the wire fixing ring is a U-shaped groove; one side of the wire fixing ring has a plurality of notches, and the distal end of the distal second elastic layer has corresponding buckles, and the wire fixing ring is fixed to the distal end of the distal second elastic layer by being snapped onto the buckles through the notches.

[0069] The positive and progressive effects of the present invention are as follows:

[0070] In the present invention, by setting the spiral elastic member into five elastic members with different degrees of density, the distal end of the delivery device can very easily pass through the aortic arch. Specifically, the spiral of the middle support section is set to be the densest form and cannot be compressed axially in the free state, the spirals of the head section and the tail section are slightly tighter, and the spirals of the far transition section and the near transition section connecting the head section, the tail section and the support section are set to be relatively sparse. In this way, it can also ensure that the spiral elastic member can reach a balance state between support and bending without causing the delivery to fail due to excessive bending of the head section and the tail section while having a certain supporting force.

[0071] The present invention adopts the proximal outer tube as a braided outer tube to improve the toughness strength, and the distal outer tube adopts a structure that is easy to bend, such as setting a first hollow groove and a second hollow groove on the two side walls of the distal outer tube, and the arrangement density of the hollow grooves is gradually increased, and the width is reduced. The first hollow groove of the first half side wall is long and wide and the length extends to the second half side wall, and the hollow groove of the second half side wall is short and narrow. In this way, it is very easy to bend the distal outer tube from one side wall to the other side wall, and the proximal outer tube of the outer sheath tube assembly is a braided structure with high strength, and the distal outer tube is easy to control bending, and the bending angle is 90° to 180°. With such a structure, it is very easy to make the delivery sheath tube bend through the aortic arch to reach the aortic valve.

[0072] The present invention extends at least two guide grooves along the axial direction on the inner wall of the inner tube, and the two guide grooves have a plurality of intersection points. The expansion fluid is transported through the guide grooves, and the outer diameter of the inner sheath tube assembly of the delivery sheath can be reduced. Similarly, the outer diameter of the outer sheath tube assembly is also reduced. The diameter of the outer sheath tube assembly of the delivery sheath can be reduced to 4-5 mm, which is smaller than the diameter of the prior art. The use of the delivery sheath provided by the present invention causes less harm to the patient. In order to smoothly deliver the sheath tube while minimizing the damage to the patient's blood vessels, it is necessary for the sheath tube to maintain a certain strength and conform to the shape of the blood vessel on the basis of minimizing the diameter, and to control the bending of the sheath tube well so as to reach the implantation site more smoothly. BRIEF DESCRIPTION OF THE DRAWINGS

[0073] Figure 1 It is a cross-sectional schematic diagram of the combination of the inner core tube assembly 10 and the inner sheath tube assembly 20 of the present invention;

[0074] Figure 2 Another schematic diagram of the appearance of the combination of the inner core tube assembly 10 and the inner sheath tube assembly 20 of the present invention;

[0075] Figure 3 It is a schematic diagram of the outer contour structure of the transfemoral valve delivery system of the present invention;

[0076] Figure 4 is a cross-sectional schematic diagram of the inner core tube assembly 10 of the present invention;

[0077] Figure 5 It is an enlarged schematic diagram of the pushing tip of the inner core tube assembly 10 of the present invention;

[0078] Figures 6A to 6H It is a structural schematic diagram of the spiral elastic member 111 of the inner core tube 11 of the present invention;

[0079] Figures 6I to 6J This is a schematic structural diagram of the spiral elastic member 111 of the present invention in use;

[0080] Figure 7 It is a schematic diagram of the unfolded structure of the inner wall of the inner tube 23 of the present invention;

[0081] Figure 8 It is a partial cross-sectional view of the inner tube of the inner sheath tube assembly 20 of the present invention;

[0082] Figure 9 It is Figure 8 a cross-sectional view at the A-A position of the inner tube in

[0083] Figure 10 It is Figure 8 a cross-sectional view at the B-B position of the inner tube in

[0084] Figure 11 It is a structural diagram of the outer sheath tube assembly 30 of the present invention;

[0085] Figure 12 It is a partial cross-sectional view of the proximal outer tube 311 of the outer sheath tube assembly 30 of the present invention;

[0086] Figure 13 It is a cross-sectional structural diagram of the proximal outer tube 311 of the outer sheath tube assembly 30 of the present invention;

[0087] Figure 14 It is a cross-sectional structural diagram of the distal outer tube 312 of the outer sheath tube assembly 30 of the present invention;

[0088] Figure 15 It is an inner cross-sectional structural diagram of the distal outer tube 312 of the outer sheath tube assembly 30 of the present invention;

[0089] Figure 15A It is a side structural diagram of the second half side wall 3122b of the distal outer tube 312 of the present invention;

[0090] Figure 15B It is a side structural diagram of the first half side wall 3122a of the distal outer tube 312 of the present invention;

[0091] Figure 16 It is a three-dimensional structural diagram of the wire fixing ring 313 of the outer sheath tube assembly 30 of the present invention. Specific embodiments

[0092] The following illustrates the implementation manners of the present invention through specific specific examples. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through different specific implementation manners. Various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0093] It should be noted that in the present invention, the terms "distal end", "proximal end", "distal segment", and "proximal segment" are used as orientation terms. These orientation terms are commonly used terms in the field of interventional medical devices. Among them, "distal end" and "distal segment" refer to the end or segment away from the operator during the surgical process, and "proximal end" and "proximal segment" refer to the end or segment close to the operator during the surgical process. The axial direction refers to the direction parallel to the line connecting the centers of the distal end and the proximal end of the medical device; the radial direction refers to the direction perpendicular to the above-mentioned axial direction.

[0094] As Figures 1 to 3 shown, the transcatheter aortic valve delivery system of the present invention, also known as the transcatheter aortic valve delivery sheath tube, includes an inner core tube assembly 10, an inner sheath tube assembly 20, an outer sheath tube assembly 30, a Y-shaped tube 40, and an operating handle 50. The inner sheath tube assembly 20 is disposed outside the inner core tube assembly 10. There is a space between the inner core tube assembly 10 and the inner sheath tube assembly 20 for the inflation fluid for balloon inflation to enter and exit. The inner core tube assembly 10 can play a guiding role. The outer sheath tube assembly 30 can be disposed outside the inner sheath tube assembly 20, and the inner sheath tube assembly 20 and the outer sheath tube assembly 30 can move relative to each other so that the outer sheath tube assembly 30 can deliver the valve stent to the human heart.

[0095] As Figure 4 shown, the inner core tube assembly 10 has an inner core tube 11, a push tip 12, and a radiopaque ring 13. The inner core tube 11 is disposed inside the inner sheath tube assembly 20, and the inner core tube 11 is a braided tube. The push tip 12 is hermetically connected to the distal end of the balloon 21 of the inner sheath tube assembly 20 and is fixedly connected to the distal end of the inner core tube 11. As Figure 5 shown, the push tip 12 has a conical head 121 and a fixing seat 122 fixed to the bottom of the conical head. The push tip 12 communicates with the distal end of the inner core tube 11 through the fixing seat 122. One end of the fixing seat 122 facing the inner core tube 11 is provided with a squeezable bell mouth 123. A plurality of V-shaped grooves 124 are provided on the periphery of the bell mouth 123. The conical head 121 is hermetically connected to the distal end of the balloon of the inner sheath tube assembly 20. The radiopaque ring 13 is fixed on the inner core tube 11 and is close to the push tip 12.

[0096] As Figure 6A shown, a spiral elastic member 111 is sleeved on the outer periphery of a part of the inner core tube 11 located inside the balloon 21, between the radiopaque rings 13. The spiral elastic member 111 is located inside the balloon 21. Its functions are as follows: on the one hand, it provides a certain supporting force for the inner core tube 11 to prevent it from being bent and folded when bent. On the other hand, when the delivery device passes through the aortic arch, the spiral elastic member 111 can ensure the smooth passage of the delivery device and complete the delivery of the valve without damaging the valve and the inner core tube 11. Both ends of the spiral elastic member 111 are fixedly connected to the outer periphery of the inner core tube 11, and the middle part of the spiral elastic member 111 can move relative to the inner core tube 11. The elasticity of the middle part of the spiral elastic member 111 is greater than that of both ends.

[0097] As shown Figures 6B to 6J , the spiral elastic member 111 specifically includes a head section 111a, a distal transition section 111b, a support section 111c, a proximal transition section 111d, and a tail section 111e in sequence from the distal end to the proximal end. The pitch t 支 of the support section 111c is 0, and it is axially non-compressible in the free state; the pitch t 远 of the distal transition section 111b is 2.5 to 3.5 times the pitch t 头 of the head section 111a, such as 2.6 times, 3.3 times, preferably 2.8 to 3.2 times, such as 2.9 times, 3.1 times, more preferably 3 times; the pitch t 近 of the proximal transition section 222d is 1.2 to 3 times the pitch t 头 of the head section 111a, such as 2.2 times, 2.8 times, preferably 1.3 to 2 times, such as 1.5 times, 1.8 times, etc.; the pitch t 尾 of the tail section 111e is 0.8 to 1.2 times the pitch t 头 of the head section 111a, such as 0.9 times, 1.1 times, etc., preferably 1 time, that is, the pitches of the two parts are equal. The pitch of the support section 111c is the smallest and it cannot be compressed axially. In this way, through the setting of the larger pitch of the distal transition section 111b, the inner core tube 11 can be bent, but it is expected that the inner core tube 11 will not be bent too much, and a smaller pitch is set at the head section again, so that the inner core tube 11 will not be bent excessively and cause the conveying to fail; the same is true for the pitch settings of the tail section 111e and the proximal transition section 111d. In this way, a good balance can be achieved between bending and support. When the valve passes through the aortic arch, during the process of the valve 60, the valve 60 is sleeved on the balloon, and the main body structure of the valve is roughly on the outer periphery of the support section 111c. To more clearly show the relative position relationship, Figure 6J only the stent part of the valve is drawn in 支 for illustration. The spiral length H 头 of the support section 111c is 3 to 6 times the spiral length H 远 of the head section 111a; the spiral length H 头 of the distal transition section 111b is 1 to 2 times the spiral length H 近 of the head section; the spiral length H 头 of the proximal transition section 111d is 2 to 5 times the spiral length H 支 of the head section 111a and less than the spiral length H 尾 of the support section; the spiral length H 头0.8 to 1.2 times, preferably 1 time. One of the functions of the support section 111c is to support the valve 60 and prevent the valve 60 from bending during transportation. Therefore, the length of the support section 111c is approximately the axial length of the valve 60. The near transition section 111d is connected to the proximal end of the delivery device. The proximal end of the delivery device has a larger length and requires a greater bend than the far transition section 111b. In addition, when the valve 60 is delivered to the target position, it is necessary to inject liquid into the balloon to expand the balloon and drive the valve 60 to expand. At this time, the near transition section 111d and the far transition section 111b of the spring can also serve as channels for the liquid, so that the far and near ends of the balloon expand simultaneously.

[0098] The pitch diameter D of the support section 111c 支 is equal to the pitch diameter D of the far transition section 111b 远 and is greater than the pitch diameter D of the head section 111a 头 , D 头 gradually decreases from the proximal end to the distal end along the head section, and gradually decreases so that the diameter can be well transitioned to the size of the inner core tube 11 to adapt to the size of the inner core tube 11; the pitch diameter D of the support section 111c 支 is equal to the pitch diameter D of the near transition section 111d 近 and is greater than the pitch diameter D of the tail section 111e 尾 , D 尾 gradually decreases from the distal end to the proximal end along the tail section. Similarly, the pitch diameter D 尾 gradually decreases so that it can well adapt to the size of the inner core tube 11. The head section 111a is fixedly connected to the outer periphery of the inner core tube 11 through the proximal end of the pushing tip 12. In order to fix the tail section 111e on the inner core tube 11, it is fixedly connected to the outer periphery of the inner core tube 11 through a tapered fixing ring 112.

[0099] In the present invention, the pitch t refers to the axial distance between corresponding points of two adjacent turns of the helix on the mean diameter. The helix length H refers to the length of the elastic member when it is free. The pitch diameter D refers to the diameter of the helix of the cross-section of the elastic member.

[0100] Continue as Figure 1 shown, the inner sheath tube assembly 20 has a balloon 21, a connecting tube 22, and an inner tube 23 from the distal end to the proximal end. The balloon 21 is sleeved on the distal end of the inner core tube 11 of the inner core tube assembly 10 and is hermetically connected to the proximal end of the pushing tip 12. The distal end of the connecting tube 22 is connected to the proximal end of the balloon 21 and is sleeved on the inner core tube 11 of the inner core tube assembly 10. The distal end of the inner tube 23 is connected to the proximal end of the connecting tube 22 and is sleeved on the proximal end of the inner core tube assembly 10. As Figure 7As shown, the inner wall of the inner tube 23 has at least two guide grooves 231 extending axially in a coiled manner, such as a spiral structure, and the at least two guide grooves 231 have a number of cross-confluence points 232. The at least two guide grooves 231 provide channels for circulating the expansion liquid, and having a plurality of cross-confluence points 232 can enable the expansion liquid such as physiological saline to have more flow paths during the flow process and be more likely to enter the balloon. As Figures 8 to 10 As shown, a limiting member 233 is provided on the outer side wall of one end of the inner tube 23 close to the operation handle 50, such as made of stainless steel, to limit the axial movement of the inner tube 23. The inner tube 23 includes a polymer outer layer 23a, a braided middle layer 23b, and a polymer inner layer 23c from outside to inside in the radial direction. The surface of the polymer outer layer 23a is a smooth surface, and the materials of the polymer outer layer 23a and the polymer inner layer 23c include but are not limited to pebax, nylon, polyurethane, rubber, SIS, etc. Since at least two guide grooves 231 extending axially in a coiled manner are provided on the inner wall of the inner tube 23 in the present invention, with the guide grooves 231, it is more convenient to perfusion physiological saline, etc., and the diameter of the inner sheath tube assembly is reduced. On the premise that the diameter of the inner sheath tube assembly becomes smaller, the outer sheath tube assembly is also reduced accordingly, reducing the damage of the outer sheath tube assembly to the blood vessel. The outer diameter of the inner sheath tube assembly 20 can be, for example, 2.5 - 3.5 mm to adapt to the characteristics that the femoral artery of Orientals is narrower than that of Westerners. Also, since a number of cross-confluence points 232 are formed when the multiple guide grooves 231 are coiled on the inner wall of the inner tube 23, the resistance received by the expansion liquid during the process of entering the balloon is smaller. The expansion liquid can be, for example, physiological saline. The expansion liquid finally flows into the balloon 21 through the guide grooves 231, propping up the entire balloon, and enabling the balloon 21 to Figure 2 the compressed state expand to Figure 1 the expanded state.

[0101] The Y-shaped tube 40 is located at the proximal end of the delivery sheath tube. The first inlet of the Y-shaped tube 40 is communicated with the proximal end of the inner core tube 11 of the inner core tube assembly 10, enabling the guide wire to pass through the inner core tube 11. The second inlet of the Y-shaped tube 40 is connected to the inner tube 23 of the inner sheath tube assembly 20, and a buffer member is sleeved at the connection. The second inlet of the Y-shaped tube 40 is communicated with the guide grooves 231 on the inner wall of the inner tube 23, serving as the expansion liquid inlet.

[0102] As Figures 11 to 14As shown, the outer sheath tube assembly 30 includes an outer tube 31, a pushing head 32, and a bending adjustment wire 33. The outer tube 31 can be disposed outside the inner sheath tube assembly 20. The outer tube 31 axially includes a proximal outer tube 311 and a distal outer tube 312 that are in communication with each other from the proximal end to the distal end. The pushing head 32 is connected to the distal end of the distal outer tube 312. The pushing head 32 is an expandable pushing head. When the balloon 21 expands, the pushing head 32 can expand slightly to block the valve 60 and prevent the valve 60 from being squeezed distally and returning into the outer sheath tube assembly 30. The bending adjustment wire 33 is hiddenly disposed along the axial direction of the outer tube 31 in the side wall of the outer tube 31. The distal end of the bending adjustment wire 33 is fixed to the distal end of the distal outer tube 312. The proximal end of the bending adjustment wire 33 is led out from near the proximal end of the proximal outer tube 311 and can be controlled by the operation handle 50 of the transcatheter aortic valve delivery system. The smaller the outer diameter of the outer sheath tube assembly 30 is, the better. For example, it can be 4-5 mm.

[0103] As Figures 12 to 13 shown, the proximal outer tube 311 radially includes a proximal first elastic layer 3111, a proximal second elastic layer 3112, and a proximal third elastic layer 3113 from the outside to the inside in sequence. The elasticity of the proximal second elastic layer 3112 is not greater than that of the proximal first elastic layer 3111 and the proximal third elastic layer 3113. Both the proximal first elastic layer 3111 and the proximal third elastic layer 3113 are made of polymer materials. The proximal first elastic layer and the proximal third elastic layer are integrally injection-molded. The hardness of the proximal first elastic layer 3111 is greater than that of the proximal third elastic layer 3113. The proximal second elastic layer 3112 is a braided wire, such as a metal material. The material of the proximal first elastic layer 3111 includes but is not limited to pebax, nylon, polyurethane, rubber, SIS, etc. The friction coefficient of the proximal third elastic layer 3113 is 0.01-0.2. The proximal third elastic layer 3113 is a polymer material with a small friction coefficient, including but not limited to PTFE, PVDF, nylon, etc. The proximal first elastic layer 3111 of the proximal outer tube 311 has an opening point 3114 near the proximal end.

[0104] As Figure 14As shown, the distal outer tube 312 includes, from outside to inside in the radial direction, a first elastic layer 3121, a second elastic layer 3122, and a third elastic layer 3123 of the distal section; the elasticity of the second elastic layer 3122 of the distal section is greater than that of the first elastic layer 3121 and the third elastic layer 3123 of the distal section, and the elasticity of the second elastic layer 3122 of the distal section is greater than that of the second elastic layer 3112 of the proximal section. Both the first elastic layer 3121 and the third elastic layer 3123 of the distal section are made of polymer materials, and the first elastic layer and the third elastic layer of the distal section are integrally injection-molded; the specific materials of the first elastic layer 3121 of the distal section include, but are not limited to, pebax, nylon, polyurethane, rubber, SIS, etc.; the second elastic layer of the distal section is made of metal materials, including, but not limited to, stainless steel, nickel-titanium alloy, cobalt-chromium alloy, titanium alloy, etc.; the third elastic layer 3123 of the distal section includes, but is not limited to, PTFE, PVDF, nylon; the friction coefficient of the third elastic layer 3123 of the distal section is 0.01 - 0.2.

[0105] As Figure 15 , 15A and Figure 15B show, the second elastic layer 3122 of the distal section has a first half side wall 3122a and a second half side wall 3122b, and the first half side wall 3122a and the second half side wall 3122b are closed to enclose the entire second elastic layer 3122 of the distal section; the first half side wall 3122a has a number of first hollow grooves 31221 arranged in parallel and spaced apart, and the first hollow grooves 31221 penetrate the entire radial direction of the first half side wall 3122a and extend through to the second half side wall 3122b, so that the angle corresponding to the arc formed by the cross-section of the first hollow groove 31221 is 180 - 330°, and the corresponding arc length can be, for example, 0.1 - 2 mm; the second half side wall 3122b has a number of second hollow grooves 31222 arranged in parallel and spaced apart, and the second hollow grooves 31222 penetrate the entire radial direction of the second half side wall 3122b, and the angle corresponding to the arc formed by the cross-section of the second hollow groove is 180°; the second hollow grooves 31222 are arranged opposite and spaced apart from the first hollow grooves 31221, and the so-called staggered and spaced arrangement means not on the same cross-section. Along the distal outer tube 312 from the proximal end to the distal end, the arrangement density of the first hollow grooves 31221 and the second hollow grooves 31222 increases in segments. And along the axial direction of the distal outer tube 312 from the proximal end to the distal end, the widths of the first hollow grooves 31221 and the second hollow grooves 31222 decrease in segments. The width of the first hollow grooves 31221 is greater than the width of the second hollow grooves 31222.

[0106] The second elastic layer 3122 in the distal section is a corrugated tube layer. The corrugated tube layer successively has a proximal corrugated tube 3122A, a middle corrugated tube 3122B, and a distal corrugated tube 3122C along the axial direction from the proximal end to the distal end. The arrangement density of the first hollow groove and the second hollow groove on the proximal corrugated tube 3122A is less than that of the first hollow groove and the second hollow groove on the middle corrugated tube 3122B, and the arrangement density of the first hollow groove and the second hollow groove on the middle corrugated tube 3122B is less than that of the first hollow groove and the second hollow groove on the distal corrugated tube 3122C. The widths of the first hollow groove and the second hollow groove on the proximal corrugated tube 3122A are respectively greater than the widths of the first hollow groove and the second hollow groove on the middle corrugated tube 3122B, and the widths of the first hollow groove and the second hollow groove on the middle corrugated tube 3122B are respectively greater than the widths of the first hollow groove and the second hollow groove on the distal corrugated tube 3122C. The arrangement density of the first hollow groove 31221 and the second hollow groove 31222 on the same corrugated tube is the same from the proximal end to the distal end; or, the arrangement density of the first hollow groove 31221 and the second hollow groove 31222 on the same corrugated tube gradually increases from the proximal end to the distal end. The widths of the first hollow groove 31221 and the second hollow groove 31222 on the same corrugated tube are the same from the proximal end to the distal end; or, the widths of the first hollow groove 31221 and the second hollow groove 31222 on the same corrugated tube gradually decrease from the proximal end to the distal end.

[0107] As Figure 16 shown, the distal end of the distal outer tube 312 has a wire fixing ring 313, and the distal end of the bending adjustment wire 33 is fixed on the wire fixing ring 313 of the distal outer tube 311. The outer side wall of the wire fixing ring 313 has a wire accommodating cavity 313a along the axial direction, which is a U-shaped groove. One side of the wire fixing ring 313 has a plurality of notches 3131, and the distal end of the second elastic layer 3122 in the distal section has corresponding buckles 31223. The wire fixing ring 313 is fixed on the distal end of the second elastic layer 3122 in the distal section by being clamped on the buckles 31223 through the notches 3131; the outer side wall of the second elastic layer 3112 in the proximal section has a proximal wire cavity (not shown in the figure), and the outer side wall of the second elastic layer 3122 in the distal section has a distal wire cavity (not shown in the figure). The wire fixing ring 313 is fixedly connected to the distal end of the second elastic layer 3122 in the distal section and is clamped between the distal ends of the first elastic layer 3121 and the third elastic layer 3123 in the distal section; the wire accommodating cavity 313a on the wire fixing ring 313 is in communication with the distal wire cavity and the proximal wire cavity; the distal end of the bending adjustment wire 33 is fixed on the wire fixing ring 313 and successively passes through the wire accommodating cavity 313a, the distal wire cavity, and the proximal wire cavity. The proximal end of the bending adjustment wire 33 is led out from the opening point 3114 near the proximal end of the proximal outer tube 311 and can be controlled by the operation handle 50 of the trans-femoral arterial valve delivery system to control the bending degree of the distal outer tube 312.

[0108] The operating handle 50 is fixedly connected to the outer tube 31 of the outer sheath tube assembly 30, and is used to control the bending of the bending wire 33 of the outer sheath tube assembly 30 and display the bending angle. An exhaust valve is connected to the operating handle 50. Before using the delivery system, physiological saline, etc. is input to discharge the air in the delivery system. The inner tube 23 of the inner sheath tube assembly 20 passes through the operating handle 50, and there is a dovetail valve that can be locked or opened at the proximal end of the operating handle 50 to fix the position of the inner tube 23.

[0109] Through structural settings and material selection, the femoral artery valve delivery sheath tube of the present invention has a certain hardness and flexibility by arranging a bending wire 33 inside the outer tube 31, and can be bent well to pass through the femoral artery of the human body and reach the human heart. In order to better cross the aortic arch near the human heart, the present invention sets a first hollow groove and a second hollow groove with gradually increasing density from the proximal end to the distal end on the second elastic layer 3122 at the distal section of the outer tube 31, and at the same time makes the widths of the first hollow groove and the second hollow groove decrease, and the central angle corresponding to the arc of the first hollow groove is greater than 180 degrees, so that the distal end of the delivery sheath tube can be bent well to smoothly cross the aortic arch.

[0110] It should be noted that the structures, proportions, sizes, etc. shown in the drawings of this specification are only used to cooperate with the content disclosed in the specification for those familiar with this technology to understand and read, and are not used to limit the conditions under which the present invention can be implemented. Therefore, they do not have technical essence. Any modification of the structure, change of the proportional relationship or adjustment of the size, without affecting the efficacy and purpose that the present invention can achieve, should still fall within the scope covered by the technical content disclosed in the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" cited in this specification are only for the convenience of clear narration, and are not used to limit the scope under which the present invention can be implemented. The change or adjustment of their relative relationship, without substantial change in technical content, should also be regarded as the scope under which the present invention can be implemented.

[0111] The present invention has been described in detail above in combination with the embodiments with drawings. Those of ordinary skill in the art can make various variations of the present invention according to the above description. Therefore, some details in the embodiments should not constitute a limitation to the present invention, and the present invention will take the scope defined by the appended claims as the protection scope.

Claims

1. A transcatheter aortic valve delivery device, comprising: An inner core tube assembly; An inner sheath tube assembly, which is disposed outside the inner core tube assembly; An outer sheath tube assembly, which is disposed outside the inner sheath tube assembly; The inner core tube assembly has an inner core tube, which is disposed inside the inner sheath tube assembly. It is characterized in that a helical elastic member is sleeved on the outer periphery of the distal end of the inner core tube. The helical elastic member includes a head section, a distal transition section, a support section, a proximal transition section, and a tail section in sequence from the distal end to the proximal end; The inner sheath tube assembly includes an inner tube disposed at the proximal end of the inner core tube assembly. The inner wall of the inner tube has at least two guiding grooves that extend axially in a coiled manner, and the at least two guiding grooves have several intersection points; The pitch t of the support section 支 is 0; The pitch t of the far transition section 远 is 2.5 to 3.5 times the pitch t of the head section 头 ; The pitch t of the near transition section 近 is 1.2 to 3 times the pitch t of the head section 头 ; The pitch t of the tail section 尾 is 0.8 to 1.2 times that of 头 the pitch t of the head section.

2. The transcatheter aortic valve delivery device according to claim 1, wherein The pitch t of the far transition section 远 is 2.8 to 3.2 times the pitch t of the head section 头 ; The pitch t of the near transition section 近 is 1.3 to 2 times the pitch t of the head section 头 ; The pitch t of the tail section 尾 is 1 times the pitch t of the head section 头 .

3. The transfemoral valve delivery device according to claim 2, characterized in that The pitch t of the far transition section 远 is three times the pitch t of the head section 头 .

4. The transcatheter aortic valve delivery device according to claim 1, wherein: The spiral length H of the support section 支 is 3 to 6 times the spiral length H 头 of the head section; The spiral length H of the far transition section 远 is 1 to 2 times the spiral length H of the head section 头 ; The spiral length H of the near transition section 近 is 2 to 5 times the spiral length H of the head section 头 and less than the spiral length H of the support section 支 ; The spiral length H of the tail section 尾 is 0.8 to 1.2 times that of 头 the spiral length H of the head section.

5. The transfemoral valve delivery device according to claim 1, wherein The spiral length H of the tail section 尾 is the spiral length H of the head section 头 by a factor of 1.

6. The transcatheter aortic valve delivery device according to claim 1, wherein: The pitch diameter D of the support section 支 is equal to the pitch diameter D of the far transition section 远 , and is greater than the pitch diameter D of the head section 头 , and the D 头 gradually decreases from the proximal end to the distal end along the head section; The pitch diameter D of the support section 支 is equal to the pitch diameter D of the near transition section 近 , and is greater than the pitch diameter D of the tail section 尾 , and the D 尾 gradually decreases from the distal end to the proximal end along the tail section.

7. The transfemoral valve delivery device according to claim 1, characterized in that: The inner core tube assembly further has: A pushing tip, the distal end of the pushing tip is hermetically connected to the distal end of the balloon of the inner sheath tube assembly and is fixedly connected to the distal end of the inner core tube, and the proximal end of the pushing tip is fixedly connected to the head section of the helical elastic member; A radiopaque ring, which is fixed on the inner core tube and is close to the pushing tip.

8. The transfemoral valve delivery device according to claim 7, characterized in that, The pushing tip has a conical head and a fixing seat fixed at the bottom of the conical head. The pushing tip is communicated with the distal end of the inner core tube through the fixing seat. One end of the fixing seat facing the inner core tube is provided with a squeezable flared opening, and a plurality of V-shaped slots are provided on the periphery of the flared opening. The conical head is hermetically connected to the distal end of the balloon of the inner sheath tube assembly.

9. The transfemoral valve delivery device according to claim 1, wherein The head section of the helical elastic member is fixedly connected to the outer periphery of the inner core tube through the proximal end of a pushing tip, the tail section of the helical elastic member is fixedly connected to the outer periphery of the inner core tube through a conical fixing ring, the middle part of the helical elastic member can move relative to the inner core tube, and the elasticity of the middle part of the helical elastic member is greater than that of the two ends.

10. The transfemoral valve delivery device according to claim 1, characterized in that, The inner sheath tube assembly has: A balloon, which is disposed at the distal end of the inner core tube assembly, and the helical elastic member is located inside the balloon; A connecting tube, the distal end of which is connected to the proximal end of the balloon and is disposed on the inner core tube assembly; The inner tube, the distal end of which is connected to the proximal end of the connecting tube and is disposed at the proximal end of the inner core tube assembly.

11. The transcatheter aortic valve delivery device according to claim 1, wherein, The outer sheath tube assembly includes: An outer tube, which can be disposed outside the inner sheath tube assembly; A pushing head, which is connected to the distal end of the outer tube.

12. The transcatheter aortic valve delivery device according to claim 11, wherein, The outer tube includes a distal outer tube along the axial direction. The interior of the distal outer tube has, in the radial direction: A plurality of first hollow slots arranged in parallel at intervals; A plurality of second hollow slots arranged in parallel at intervals, which are relatively spaced apart and staggered from the first hollow slots; Wherein, along the axial direction of the distal outer tube from the proximal end to the distal end, the arrangement density of the first hollow slots and the second hollow slots increases in segments.

13. The transfemoral valve delivery device according to claim 12, wherein Axially from the proximal end to the distal end along the distal outer tube, the widths of the first hollow groove and the second hollow groove are gradually decreasing in sections.

14. The transfemoral valve delivery device according to claim 12 or 13, wherein the distal outer tube sequentially includes, from outside to inside in the radial direction: a first elastic layer of the distal section, a second elastic layer of the distal section, and a third elastic layer of the distal section; the second elastic layer of the distal section has a first half side wall and a second half side wall, and the first half side wall and the second half side wall are closed to enclose the entire second elastic layer of the distal section; the first hollow groove penetrates the entire radial direction of the first half side wall and extends all the way through to the second half side wall; the second hollow groove penetrates the radial direction of the second half side wall.

15. The transfemoral valve delivery device according to claim 14, wherein the first hollow groove penetrates the entire radial direction of the first half side wall and extends all the way through to the second half side wall, so that the angle corresponding to the arc formed by the cross section of the first hollow groove is 180° to 330°; the second hollow groove penetrates the radial direction of the second half side wall, and the angle corresponding to the arc formed by the cross section of the second hollow groove is not greater than 180°.

16. The transfemoral valve delivery device according to claim 12, wherein: The width of the first hollow groove is greater than the width of the second hollow groove.

17. The transfemoral valve delivery device according to claim 14, wherein: The second elastic layer of the distal section is a corrugated pipe layer, and the corrugated pipe layer sequentially has a proximal corrugated pipe, a middle corrugated pipe, and a distal corrugated pipe along the axial direction from the proximal end to the distal end. The arrangement density of the first hollow groove and the second hollow groove on the proximal corrugated pipe is less than the arrangement density of the first hollow groove and the second hollow groove on the middle corrugated pipe, and the arrangement density of the first hollow groove and the second hollow groove on the middle corrugated pipe is less than the arrangement density of the first hollow groove and the second hollow groove on the distal corrugated pipe.

18. The transfemoral valve delivery device according to claim 14, characterized in that: The second elastic layer of the distal section is a corrugated pipe layer, and the corrugated pipe layer sequentially has a proximal corrugated pipe, a middle corrugated pipe, and a distal corrugated pipe along the axial direction from the proximal end to the distal end. The widths of the first hollow groove and the second hollow groove on the proximal corrugated pipe are respectively greater than the widths of the first hollow groove and the second hollow groove on the middle corrugated pipe, and the widths of the first hollow groove and the second hollow groove on the middle corrugated pipe are respectively greater than the widths of the first hollow groove and the second hollow groove on the distal corrugated pipe.

19. The transfemoral valve delivery device according to claim 17, wherein The arrangement density of the first hollow groove and the second hollow groove on the same corrugated pipe is the same from the proximal end to the distal section; or, the arrangement density of the first hollow groove and the second hollow groove on the same corrugated pipe gradually increases from the proximal end to the distal section.

20. The transfemoral valve delivery device according to claim 18, wherein The widths of the first hollow groove and the second hollow groove on the same corrugated pipe are the same from the proximal end to the distal section; or, the widths of the first hollow groove and the second hollow groove on the same corrugated pipe gradually decrease from the proximal end to the distal section.

21. The transfemoral valve delivery device according to claim 14, wherein the outer tube includes a proximal outer tube and the distal outer tube that are interconnected along the axial direction from the proximal end to the distal end; The outer sheath tube assembly includes: a bending adjustment wire, which is hiddenly disposed along the axial direction of the outer tube in the side wall of the outer tube. The distal end of the bending adjustment wire is fixed to the distal end of the distal outer tube, and the proximal end of the bending adjustment wire is led out from near the proximal end of the proximal outer tube and can be controlled by the operating handle of the transfemoral valve delivery device.

22. The transfemoral valve delivery device according to claim 21, wherein the proximal outer tube sequentially includes, from outside to inside in the radial direction: a proximal first elastic layer, a proximal second elastic layer, and a proximal third elastic layer, and the elasticity of the proximal second elastic layer is not greater than the elasticity of the proximal first elastic layer and the proximal third elastic layer; wherein, the elasticity of the distal second elastic layer is greater than the elasticity of the proximal second elastic layer.

23. The transfemoral valve delivery device according to claim 22, wherein: the distal end of the distal outer tube has a wire fixing ring, and the distal end of the bending adjustment wire is fixed to the wire fixing ring of the distal outer tube.

24. The transfemoral valve delivery device according to claim 23, wherein: the outer side wall of the wire fixing ring has a wire accommodating cavity along the axial direction, the outer side wall of the proximal second elastic layer has a proximal wire cavity along the axial direction, and the outer side wall of the distal second elastic layer has a distal wire cavity along the axial direction; the wire fixing ring is fixedly connected to the distal end of the distal second elastic layer and is clamped between the distal ends of the distal first elastic layer and the distal third elastic layer; the wire accommodating cavity on the wire fixing ring is in communication with the distal wire cavity and the proximal wire cavity; the distal end of the bending adjustment wire is fixed to the wire fixing ring and sequentially passes through the wire accommodating cavity, the distal wire cavity, and the proximal wire cavity, and the proximal end of the bending adjustment wire is led out from near the proximal end of the proximal outer tube and can be controlled by the operating handle of the transfemoral valve delivery device.

25. The transfemoral valve delivery device according to claim 24, wherein: The proximal first elastic layer of the proximal outer tube has an opening point near the proximal end, and the proximal end of the bending adjustment wire is led out from the opening point.

26. The transfemoral valve delivery device according to claim 24, characterized in that: The wire accommodating cavity of the wire fixing ring is a U-shaped groove; one side of the wire fixing ring has a plurality of notches, and the distal end of the distal second elastic layer has corresponding buckles, and the wire fixing ring is fixed to the distal end of the distal second elastic layer by being clamped in the buckles through the notches.

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