WO2024114363A1 - 一种可调弯输送系统 - Google Patents
一种可调弯输送系统 Download PDFInfo
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- WO2024114363A1 WO2024114363A1 PCT/CN2023/131493 CN2023131493W WO2024114363A1 WO 2024114363 A1 WO2024114363 A1 WO 2024114363A1 CN 2023131493 W CN2023131493 W CN 2023131493W WO 2024114363 A1 WO2024114363 A1 WO 2024114363A1
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- Prior art keywords
- adjustable
- bending
- bend
- traction
- traction wire
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
Definitions
- the present invention relates to the technical field of interventional medical devices, and in particular to an adjustable bend delivery system.
- Aortic diseases such as aortic aneurysm and aortic dissection are among the most deadly and difficult to treat vascular surgical diseases.
- Traditional treatment methods are surgical operations, which have the risk of large surgical trauma and high mortality.
- a minimally invasive and simple interventional surgical method has been developed, in which a covered stent is implanted into the diseased blood vessel.
- the covered stent is tightly attached to the inner wall of the blood vessel, isolating the vascular lesion from the blood flow.
- the covered stent can not only allow blood to circulate normally, but also protect the diseased blood vessels and effectively repair vascular lesions.
- Reconstructing the aortic arch requires the use of a delivery device to deliver the stent to the aortic arch and release it.
- the current delivery device needs to be released along the greater curvature of the aortic arch when it is released, so that the proximal end of the covered stent cannot be tightly attached to the wall on the lesser curvature, presenting a "bird's beak” effect, making it impossible for the interventional device to be accurately placed, resulting in internal leakage.
- the present invention provides an adjustable bend delivery system, aiming to solve the problem that existing interventional instruments cannot be accurately placed.
- the present invention adopts the following technical solutions:
- the present invention provides a conveying system, comprising a sheath-core assembly for conveying an interventional instrument detachably connected thereto to a preset position and a traction wire for pulling the sheath-core assembly to bend under the action of an external force;
- the sheath-core assembly comprises an adjustable bending section located at the distal end, the distal end of the traction wire is connected to the adjustable bending section, and pulling the traction wire can at least cause the adjustable bending section to bend relative to the longitudinal center axis of the sheath-core assembly.
- the sheath-core assembly includes an inner sheath-core assembly and/or an outer sheath-core assembly, and the distal end of the traction wire is connected to the distal end of the inner sheath-core assembly and/or the distal end of the outer sheath-core assembly; wherein, when the sheath-core assembly includes both the inner sheath-core assembly and the outer sheath-core assembly, the inner sheath-core assembly and the outer sheath-core assembly are at least partially nested, and the distal end of the inner sheath-core assembly is closer to the distal end of the conveying system, and the outer sheath-core assembly can move axially relative to the inner sheath-core assembly.
- the inner sheath core assembly includes an inner sheath core tube, a A guide head at the distal end of the tube and a barb fixed to the proximal end of the guide head; when the distal end of the traction wire is connected to the distal end of the inner sheath core assembly, the distal end of the traction wire is connected to at least one of the distal end of the inner sheath core tube, the guide head and the barb.
- the barb includes a connecting portion connected to the proximal end of the guide head and a limiting portion connected to the proximal end of the connecting portion, and the limiting portion protrudes radially from the connecting portion; when the distal end of the traction wire is connected to the barb, an axially penetrating connecting hole is provided on the portion of the limiting portion protruding from the connecting portion, and the traction wire can pass through the connecting hole to be connected to the barb.
- the outer sheath-core assembly includes an outer sheath core tube and an anchor member disposed at the distal end of the outer sheath core tube; when the distal end of the traction wire is connected to the distal end of the outer sheath-core assembly, the distal end of the traction wire is connected to at least one of the distal end of the outer sheath core tube and the anchor member.
- the delivery system also includes a hollow outer sheath tube that is sleeved on the outside of the sheath-core assembly, the distal end of the sheath-core assembly is closer to the distal end of the delivery system, there is a first gap between the outer sheath tube and the sheath-core assembly, and the outer sheath tube can move axially relative to the sheath-core assembly.
- the traction wire can be placed in the first gap and move axially in the first gap; or a first limiting channel is axially provided on the tube wall of the outer sheath tube, and the traction wire can be placed in the first limiting channel and move axially in the first limiting channel.
- the delivery system further comprises a push rod disposed in the first gap between the sheath core assembly and the outer sheath tube, and a second gap exists between the push rod and the sheath core assembly.
- the traction wire can be placed in the second gap and move axially in the second gap; or a second limiting channel is axially provided on the tube wall of the push rod, and the traction wire can be placed in the second limiting channel and move axially in the second limiting channel.
- the conveying system also includes a fixing part fixed on the adjustable bend section of the sheath-core assembly, and the fixing parts are provided in m numbers, wherein 1 ⁇ m and m is a natural number, and the m fixing parts are arranged at intervals along the axial direction of the adjustable bend section.
- the fixing part is provided with a traction channel for the traction wire to pass through, and the traction wire can move axially relative to the fixing part. After passing through the traction channel, the traction wire is connected to the adjustable bend section and an initial traction point is formed at the connection point.
- the conveying system also includes a blocking member fixed on the traction wire, and a preset distance is provided between the blocking member and the fixing member adjacent to the proximal side thereof. During the process of pulling the traction wire, the blocking member can abut against the fixing member as the traction wire moves and form a new traction point at the abutment between the two.
- the conveying system further comprises a
- the bending control sleeves on the traction wire are provided with p pieces, 1 ⁇ p and p is a natural number, the sum of the axial lengths of the p pieces of the bending control sleeves is not greater than the effective bending length of the adjustable bending section, and the p pieces of the bending control sleeves are used to adjust the bending degree of the adjustable bending section during the pulling process.
- the adjustable bend section is provided with a plurality of pulling points, and the pulling points include at least r axial connection points spaced apart along the axial direction of the adjustable bend section, 2 ⁇ r and r is a natural number; the traction wire is provided with s roots, 2 ⁇ s and s is a natural number; wherein, r ⁇ s, the distal ends of r of the s traction wires are respectively connected to the r axial connection points to form r axial pulling points, and the s traction wires are pulled to adjust the bending degree of the adjustable bend section.
- the present invention also provides a segmented bending conveying system, comprising an adjustable bending member with a preset axial length, a traction wire for pulling the adjustable bending member to bend under the action of tension, and a bending control assembly for realizing the segmented bending of the adjustable bending member; wherein the adjustable bending member comprises an adjustable bending section located at the distal end, and the bending control assembly comprises a fixing member fixed on the adjustable bending section and a blocking member fixed on the traction wire, the fixing member is provided with a traction channel for the traction wire to pass through, the distal end of the traction wire passes through the traction channel and is connected with the distal end of the adjustable bending section to form an initial traction point at the connection, and a preset distance is provided between the blocking member and the adjacent fixing member located on the proximal side thereof; in the process of pulling the traction wire, the blocking member can abut against the fixing member as the traction wire moves and form a new traction point at the abutment between
- n fixing members there are m fixing members, 1 ⁇ m and m is a natural number, and the m fixing members are spaced apart along the axial direction of the adjustable bending section; there are n blocking members, 1 ⁇ n and n is a natural number, and the n blocking members are spaced apart along the axial direction of the traction wire; the n blocking members can be selectively spaced apart and located on the distal side of the m fixing members, so that the blocking members can abut against the fixing members adjacent to the proximal side thereof as the traction wire moves and form a new pulling point at the abutment between the two.
- the n blocking members correspond one-to-one with n of the m fixing members, so that each blocking member has an adjacent fixing member on its proximal side, and there is a preset spacing between each blocking member and the adjacent fixing member on its proximal side, thereby forming n preset spacings, and the sizes of the n preset spacings are equal or different.
- the n blocking members are matched one by one with the m fixing members, so that each blocking member has a fixing member adjacent to it on its proximal side, and there is a preset spacing between each blocking member and the fixing member adjacent to it on its proximal side, thereby forming n preset spacings, and the sizes of the n preset spacings are equal or different.
- the n preset intervals gradually increase from far to near, so that in the process of pulling the traction wire, the n blocking members can abut against the fixing members adjacent to the proximal side of the traction wire in turn as the traction wire moves and form n new traction points in turn at the abutment points.
- the blocking member is spherical, and/or cylindrical, and/or ellipsoidal, and/or conical.
- the blocking member and the fixing member are in elastic contact with each other.
- an axially compressible elastic portion is provided on the proximal side of the blocking member and/or on the distal side of the fixing member adjacent to the blocking member.
- the fixing member is a coil spring which can be sleeved on the adjustable bend section and fixed relative to the adjustable bend section at its proximal end, and the inner diameter of the coil spring is greater than the outer diameter of the adjustable bend section.
- the blocking member may pass through the traction channel on the fixing member when the tension applied to the traction wire exceeds a preset tension.
- a limiting groove is provided on one of the fixing member and the blocking member, so that the other one can be fully or partially embedded in the limiting groove when abutting.
- the present invention also provides a controllable bending conveying system, comprising an adjustable bending member with a preset axial length, a traction wire for pulling the adjustable bending member to bend under the action of tension, and a bending control assembly for controlling the bending degree of the adjustable bending member; wherein the adjustable bending member comprises an adjustable bending section located at the distal end; the distal end of the traction wire is connected to the distal end of the adjustable bending section, and is used to pull the adjustable bending section to bend under the action of external force; the bending control assembly comprises a bending control sleeve arranged on the traction wire opposite to the adjustable bending section, and p of the bending control sleeves are provided, 1 ⁇ p and p is a natural number, the sum of the axial lengths of the p bending control sleeves is not greater than the effective bending length of the adjustable bending section, and the p bending control sleeves are used to adjust the bending degree of the adjustable bending section during the pulling process.
- the bending control assembly also includes a fixing part fixed on the adjustable bending section, and the fixing parts are provided with m pieces, 1 ⁇ m and m is a natural number, the m fixing parts are arranged at intervals along the axial direction of the adjustable bending section, and the m spaced fixing parts divide the adjustable bending section into m+1 adjustable bending sub-segments; the fixing part is provided with a traction channel for the traction wire to pass through, and the distal end of the traction wire passes through the traction channel and is connected to the distal end of the adjustable bending section; wherein, 1 ⁇ p ⁇ m+1, the p bending control sleeves can be selectively opposed to p sub-segments among the m+1 sub-segments, and the axial length of each bending control sleeve is not greater than the effective bending length of the sub-segment opposite thereto.
- the bending control sleeve is movably mounted on the traction wire so that the The bending control sleeve can move axially on the traction wire relative to the bending control sleeve.
- the m+1 adjustable sub-segments are, from the distal end to the proximal end of the adjustable bending member, the first sub-segment, the second sub-segment...the m+1 sub-segment; wherein, among the m+1 adjustable sub-segments, one sub-segment is used to be opposite to the aortic arch, and the sub-segment opposite to the aortic arch has the largest effective bending length; and one of the p control bending sleeves is arranged on the traction wire opposite to the sub-segment having the largest effective bending length.
- the second sub-segment is used to be opposite to the aortic arch, and the second sub-segment has a maximum effective bending length, wherein a bending control sleeve is arranged on the traction wire opposite to the second sub-segment.
- the (m+1)th subsegment has the smallest effective bending length.
- the effective bending length of the (m+1)th subsegment is no more than 20 mm.
- the p bending control sleeves include a rigid sleeve that cannot undergo axial deformation and/or an elastic sleeve that can undergo axial deformation.
- the elastic stiffness coefficients of the two elastic sleeves increase sequentially from far to near.
- the bending control sleeve includes q sub-sleeves arranged in sequence along the axial direction of the traction wire, 1 ⁇ q and q is a natural number, the q sub-sleeves are connected or not connected, and the sum of the axial lengths of the q sub-sleeves is not greater than the effective bending length of the adjustable bending section opposite thereto.
- the bending control sleeve comprises an elastic sleeve that can undergo axial deformation
- there are at least two sub-elastic sleeves among the q sub-sleeves the elastic stiffness coefficients of the two sub-elastic sleeves are different.
- the elastic stiffness coefficients of the two sub-elastic sleeves increase sequentially from far to near.
- the fixing member includes a coil spring, which is sleeved on the adjustable bending section and at least partially fixed to the adjustable bending section, and a traction channel for the traction wire to pass through is provided between the adjustable bending section and the coil spring.
- the present invention also provides an adjustable bend delivery system, comprising an adjustable bend member having a preset axial length and a traction wire for pulling the adjustable bend member to bend under the action of a pulling force;
- the adjustable bend member comprises an adjustable bend section at a distal end, the adjustable bend section is provided with a plurality of pulling points, the pulling points at least comprising r axial pulling points spaced apart along the axial direction of the adjustable bend section, 2 ⁇ r and r is a natural number;
- the traction wires are provided with s pieces, 2 ⁇ s and s is a natural number; wherein, r ⁇ s, the distal ends of r pieces of the traction wires are respectively connected to the r axial pulling points, and the s traction wires are pulled to adjust the bending degree of the adjustable bending section.
- the r axial pulling points are not all located on the same longitudinal straight line, so that the projections of the r axial pulling points in the axial direction perpendicular to the adjustable bending member do not completely overlap.
- the r axial pulling points are all located on the small bend side of the adjustable bending member.
- the adjustable bending section when r ⁇ s and the difference is a, also includes a circumferential pulling point located on the same circumference as the axial pulling point, and there are a circumferential pulling points, and the a circumferential pulling points are all located on the same circumference or are not evenly located on the same circumference, and the distal ends of the a traction wires are respectively connected to the a circumferential connection points.
- a of the circumferential pulling points are all located on the small bend side of the adjustable bending member.
- the adjustable bend conveying system also includes a fixing part fixed on the adjustable bend section, and the fixing parts are provided in m numbers, 1 ⁇ m and m is a natural number, and the m fixing parts are arranged at intervals along the axial direction of the adjustable bend section, and the fixing part is provided with a traction channel for the traction wire to pass through.
- the adjustable bend conveying system further includes a blocking member, wherein n blocking members are provided, wherein 1 ⁇ n ⁇ s and n is a natural number, and the n blocking members can be selectively fixed on the s traction wires, and the n blocking members are arranged at intervals along the axial direction; wherein one blocking member is located at the distal side of one of the fixing members and at the proximal side of one of the pulling points, so that the blocking member can abut against the fixing member adjacent to its proximal side as the traction wire moves and form a new pulling point at the abutment between the two.
- the adjustable bend member also includes a support section connected to the proximal side of the adjustable bend section, and the adjustable bend conveying system also includes a push rod mounted outside the support section, and a second limiting channel is axially provided on the tube wall of the push rod for the traction wire to pass through, and the second limiting channels are provided with t numbers, and the t second limiting channels are parallel to each other, wherein 1 ⁇ t ⁇ s and t is a natural number.
- the t second limiting channels are all located on the small bend side of the adjustable bend member.
- the adjustable bend conveying system also includes a bend control sleeve that is sleeved on the outside of the traction wire opposite to the adjustable bend section.
- the bend control sleeves are provided with p pieces, 1 ⁇ p and p is a natural number, the sum of the axial lengths of the p pieces of the bend control sleeves is not greater than the effective bending length of the adjustable bend section, and the p pieces of the bend control sleeves are used to further adjust the degree of bending of the adjustable bend section during the pulling process.
- the delivery system of the present invention can adjust the bending angle of the front end of the delivery system, so that the stent can reach the bending part smoothly and the front end of the stent can be located in the middle of the aortic arch when released, thereby reducing the "bird's beak" effect.
- the setting of the limiter and the blocking member 800 not only avoids the entanglement of the pulling member, but also controls the direction and segment of the bending adjustment, thereby achieving precise step-by-step segmented bending control.
- the setting of the bending control sleeve and multiple traction wires can make the bending adjustment method more flexible, improve the bending performance of the delivery system, and ensure that the interventional device can be accurately delivered and released to the preset position.
- FIG1 is a schematic structural diagram of an exemplary conveying system of the present invention.
- FIG2 is a second structural schematic diagram of an exemplary conveying system of the present invention.
- FIG3 is a third schematic diagram of a partial structure of an exemplary conveying system of the present invention.
- FIG4 is a schematic diagram of the connection between an exemplary outer sheath tube and a fixed base in a handle according to the present invention
- FIG5 is a schematic diagram of the structure of an exemplary push rod and an outer sheath tube of the present invention.
- FIG6 is a schematic diagram of a connection between an exemplary traction wire and a handle of the present invention.
- FIG7 is another schematic diagram of the connection between the traction wire and the handle according to an exemplary embodiment of the present invention.
- FIG8( a ) is a schematic structural diagram of an exemplary stent with a semi-release structure according to the present invention.
- FIG8( b ) is a schematic diagram of another structure of an exemplary stent with a semi-release structure after release according to the present invention.
- FIG8( c ) is a schematic diagram of another structure of an exemplary stent with a semi-release structure before release according to the present invention.
- FIG9 is a schematic structural diagram of an exemplary inner sheath core assembly of the present invention.
- FIG10 is a schematic diagram of a connection between an exemplary traction wire and a barb of an inner sheath core assembly of the present invention
- FIG11 is another schematic diagram of the connection between an exemplary traction wire and a barb of an inner sheath core assembly according to the present invention.
- FIG12 is a schematic structural diagram of an exemplary outer sheath core assembly of the present invention.
- FIG. 13 is a schematic structural diagram of an anchor member of an exemplary outer sheath core assembly of the present invention.
- FIG14 is a schematic diagram of an exemplary traction wire passing through the gap between the stent fixing rods of the anchor member and connecting with the barb according to the present invention
- FIG15 is a schematic diagram of the delivery system of the present invention without a fixing member when bending in a blood vessel;
- FIG16 is a schematic structural diagram of an exemplary conveying system of the present invention when a fixing member is provided;
- FIG17 is another schematic diagram of the structure of an exemplary conveying system of the present invention when a fixing member is provided;
- FIG18 is a schematic structural diagram of an exemplary fixing member of the present invention.
- FIG19 is a schematic structural diagram of an exemplary conveying system of the present invention when a plurality of fixing members are provided;
- FIG20 is another schematic diagram of the structure of an exemplary conveying system of the present invention when multiple fixing members are provided;
- FIG21 is another schematic diagram of the structure of an exemplary conveying system of the present invention when multiple fixing members are provided;
- FIG22 is a schematic diagram of the delivery system provided with a fixing member of the present invention when bending in a blood vessel;
- FIG23 is a schematic structural diagram of an exemplary traction wire of the present invention when a blocking member is provided;
- FIG24 is a schematic diagram of the delivery system of the present invention when the fixing member and the blocking member cooperate with each other and when the delivery system is bent in a blood vessel;
- FIG25 is a half-section schematic diagram of an exemplary fixing member provided with a limiting groove according to the present invention.
- FIG26 is a schematic diagram of an exemplary embodiment of elastically abutting the blocking member and the fixing member of the present invention.
- FIG27 is a schematic diagram of an exemplary blocking member of the present invention that elastically abuts against a fixing member and can pass through the fixing member;
- FIG28 is another schematic diagram of an exemplary blocking member of the present invention that elastically abuts against a fixing member and can pass through the fixing member;
- FIG29 is a schematic diagram of the structure of a bending control sleeve in an exemplary conveying system of the present invention.
- FIG30 is a first schematic diagram of an exemplary bending control sleeve of the present invention being a rigid sleeve;
- FIG31 is a second schematic diagram of bending adjustment in which the bending control sleeve is a rigid sleeve according to an exemplary embodiment of the present invention
- FIG32 is a schematic diagram of one application scenario of an exemplary delivery system with a bending control sleeve in a human blood vessel of the present invention
- FIG33 is a schematic diagram of an exemplary conveying system provided with a bending control sleeve according to the present invention, in which a plurality of sub-sleeves are provided in the same area;
- FIG34 is a schematic diagram of a structure in which a plurality of pulling points are provided in an exemplary conveying system of the present invention.
- 35 and 36 are respectively bending states 1 and 2 of the adjustable bending section when pulling the traction wire in the exemplary delivery system with multiple pulling points of the present invention
- FIG37 is a diagram showing a connection method of multiple traction wires in a delivery system with multiple traction points according to an exemplary embodiment of the present invention
- 41 is a schematic cross-sectional view of a push rod of an exemplary delivery system provided with multiple pulling points according to the present invention
- first, second, third, etc. can be used in the text to describe multiple elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates, terms such as “first”, “second” and other numerical terms do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teaching of the example embodiments.
- spatial relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figure, such as “inside”, “outside”, “inner side”, “outer side”, “below”, “below”, “above”, “above”, etc.
- Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, then the elements described as “below other elements or features” or “below other elements or features” will subsequently be oriented as “above other elements or features" or “above other elements or features”. Therefore, the example term “below" can include both upper and lower orientations.
- the device can be oriented otherwise (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.
- the present invention aims to provide a delivery system to deliver the interventional instruments loaded therein to a preset position.
- the delivery system at least includes an adjustable bending member with a preset axial length and a traction wire for pulling the adjustable bending member to bend under the action of tension.
- the adjustable bending member includes an adjustable bending section located at the distal end, and the traction wire is connected to the adjustable bending section. Pulling the traction wire can at least bend the adjustable bending section relative to the longitudinal center axis of the adjustable bending member.
- the interventional instruments include but are not limited to stents, occluders, interventional artificial heart valves, etc.
- stents as an example to exemplify the delivery system of the present invention, and it should be understood that it is not limited to this. It should be noted that all the following embodiments are based on the overall delivery system. The following embodiments will be combined into the overall delivery system individually or in combination to seek a better bending solution and effect to solve the problem that the interventional instruments in the prior art cannot be accurately placed.
- the conveying system of this embodiment is further limited to the adjustable bending component as a sheath-core assembly on the basis of the overall conveying system. That is, the conveying system of this embodiment includes a sheath-core assembly and a traction wire.
- the sheath-core assembly is used to be detachably connected to the interventional instrument and to convey the interventional instrument detachably connected thereto to a preset position, and the traction wire is used to pull the sheath-core assembly to bend under the action of an external force.
- the interventional instrument detachably connected to the sheath-core assembly can bend along with the bending of the sheath-core assembly during the entire process (including the conveying and semi-release process), so that the interventional instrument can be accurately delivered and released to the preset position.
- the delivery system of this embodiment includes a sheath-core assembly 100 and a traction wire 200.
- the sheath-core assembly 100 includes an adjustable bend section 100a located at the distal end, wherein the length and dividing boundary of the adjustable bend section 100a can be set as needed and are not specifically limited.
- the distal end of the traction wire 200 is connected to the adjustable bend section 100a, and pulling the traction wire 200 can at least bend the adjustable bend section 100a relative to the longitudinal center axis x of the sheath-core assembly 100.
- the sheath-core assembly 100 is a component with a preset axial length, inevitably, the sheath-core assembly 100 has a longitudinal center axis x, and the traction wire 200 is offset from the sheath-core assembly 100.
- One side, and the distal end of the traction wire 200 is connected to the adjustable curved section 100a located at the distal end of the sheath core component 100, and the traction wire 200 is pulled to make the adjustable curved section 100a deflect relative to the longitudinal center axis x of the sheath core component 100.
- the connection between the distal end of the traction wire 200 and the adjustable curved section 100a can be a fixed connection or a detachable connection.
- the delivery system of this embodiment can bend the adjustable bending section 100a of the sheath-core assembly during the process of pulling the traction wire.
- an interventional device such as a stent
- the sheath-core assembly can still carry the interventional device detachably connected thereto for bending during the pulling of the traction wire, and the distal end of the delivery system can still be adjusted to change the bending angle of the distal end of the delivery system, so that the stent can reach the bending part smoothly and accurately, and the distal end of the stent can be located in the middle of the aortic arch when released, thereby avoiding internal leakage and reducing the "bird's beak" effect, solving the problem that the distal end of the stent cannot be tightly attached to the wall on the lesser bend side.
- the delivery system of the present embodiment also includes a hollow outer sheath tube 300, the outer sheath tube 300 is sleeved on the outside of the sheath core component 100, and the distal end of the sheath core component 100 is closer to the distal end of the delivery system, that is, the distal end of the sheath core component 100 extends relative to the distal end of the outer sheath tube 300, and there is a first gap w1 between the inner wall of the outer sheath tube 300 and the outer wall of the sheath core component 100, and the outer sheath tube 300 can move axially relative to the sheath core component 100.
- the hollow outer sheath tube 300 is an adjustable bend outer sheath tube or a non-adjustable bend outer sheath tube, and the adjustable bendability of the outer sheath tube 300 can be selected according to actual needs, and is not limited here.
- the outer sheath tube 300 is an adjustable bend outer sheath tube, and the adjustable bend outer sheath tube can further enhance the adjustable bendability of the delivery system to further ensure that the interventional instrument can smoothly reach the curved part.
- the distal end of the outer sheath can be pre-bent, and the pre-bent outer sheath is easier to bend.
- the distal end of the delivery system loaded with the interventional device is slightly bent, so that it is easier to pass through the curved blood vessels.
- the specific structure and adjustment method of the adjustable outer sheath 300 can refer to the existing technology and will not be described in detail here.
- the tube body of the outer sheath tube 300 is a hollow tube
- the other end of the outer sheath tube 300 is connected to the fixed base M
- the handle 500 has a built-in groove structure (not shown) connected to the fixed base M.
- the outer sheath tube 300 is pulled by retracting the handle 500 to move the outer sheath tube 300 backward relative to the sheath core assembly 100, thereby releasing the stent in the loading area 301a and releasing the radial constraint of the stent by the outer sheath tube 300.
- the delivery system of this embodiment further includes a push rod 400 sleeved on the sheath core assembly 100.
- the delivery system When the delivery system is loaded with a stent 600, the distal end surface of the push rod 400 sleeved on the sheath core assembly 100 is aligned with the proximal end surface of the stent 600.
- the delivery system includes the outer sheath tube 300 , the push rod 400 is located in the first gap w1 between the sheath core assembly 100 and the outer sheath tube 300 , and a second gap w2 exists between the inner wall of the push rod 400 and the outer wall of the sheath core assembly 100 .
- the main body of the push rod 400 is a hollow tube made of a relatively hard polymer material, and the proximal end of the push rod 400 is relatively fixed to the handle of the delivery system through a limiting structure (not shown) of the delivery system and cannot move axially.
- a small channel hole 401 is provided on the wall of the hollow tube.
- a plurality of small channel holes 401 are provided, and the plurality of small channel holes 401 can be arranged at intervals along the circumferential direction of the wall of the hollow tube.
- the delivery system of this embodiment also includes a handle 500, and the proximal end of the sheath core assembly 100 and the proximal end of the traction wire 200 are both extended into the handle 500 and connected to the handle 500, and the proximal end of the traction wire 200 is pulled by the handle 500 to at least bend the distal end of the sheath core assembly 100 relative to its axis.
- the delivery system also includes an outer sheath tube 300 and/or a push rod 400
- the proximal ends of the outer sheath tube 300 and/or the push rod 400 are also extended into the handle 500 and connected to the delivery handle, and the outer sheath tube 300 is axially moved and the push rod 400 is fixed by the handle 500.
- the outer sheath tube 300 is an adjustable bending sheath tube
- the outer sheath tube 300 can also be adjusted and axially moved by the handle 500.
- connection and operation of the sheath core assembly 100, the outer sheath tube 300 and the push rod 400 with the handle 500 can refer to the prior art and will not be described in detail here.
- the connection of the traction wire 200 with the handle 500 will be described as an example below, but it should be noted that the connection is not limited to this.
- a plurality of groove buckles 501 are provided in the axial direction of the handle 500 to form a plurality of gears, and each gear can be set to correspond to a bending angle.
- the limiter N1 is buckled and connected to the handle 500, and the limiter N1 is connected to the proximal end of the traction wire 200.
- the gear to move the limiter N1 the traction wire 200 can be pulled to make the traction wire 200 stressed.
- the distal end of the sheath core assembly 100 is subjected to bending force, achieving the effect of different bending angles.
- a threaded structure is provided inside the handle 500, and the stopper N2 is threadedly connected to the handle 500, and the stopper N2 is connected to the proximal end of the traction wire 200, and the traction wire 200 is pulled by rotation to make the traction wire 200 stressed.
- the traction wire 200 is stressed, the distal end of the sheath core assembly 100 is subjected to bending force to achieve the effect of different bending angles.
- the above method is only an exemplary description, and the connection method of the traction wire 200 and the handle 500 is not limited to this.
- the delivery system of this embodiment is further preloaded with an interventional device.
- the interventional device is a stent 600.
- the distal end of the stent 600 is detachably connected to the distal end of the sheath core assembly 100, so that before the stent 600 is not separated from the sheath core assembly 100, the stent 600 can be deflected with the bending of the sheath core assembly 100, thereby adjusting the position of the stent 600.
- the stent 600 when the delivery system is provided with an outer sheath tube 300, the stent 600 is radially compressed and accommodated in the first gap w1 between the outer sheath tube 300 and the sheath core assembly 100, and the distal end of the stent 600 accommodated in the first gap w1 is detachably connected to the distal end of the sheath core assembly 100.
- the outer sheath tube 300 moves back toward the proximal end, so that the stent 600 is freed from the radial constraint brought to it by the outer sheath tube 300.
- the stent 600 includes a straight metal skeleton 610 with superelasticity and an outer polymer film 620, wherein a portion of the metal skeleton at the distal end is not wrapped with the polymer film, that is, a bare stent 610a is formed, and the bare stent 610a is hooked on the distal end of the sheath core component 100, thereby realizing a detachable connection between the distal end of the stent 600 and the distal end of the sheath core component 100.
- the structure of the stent 600 is not limited to this.
- the stent 600 is a stent with a semi-release structure.
- the semi-release structure includes a wire buckle 630 and a release member 640.
- the wire buckle 630 is made of a polymer material and is disposed on the metal skeleton 610.
- the wire buckle 630 is fixed on the crest of the metal skeleton 610.
- the release member 640 is a movable metal rod or metal wire, which is located on one side of the stent 600. All the wire buckles 630 are sleeved on the release member 640 to achieve the purpose of radial compression of the stent 600.
- the stent 600 is no longer constrained in the radial direction and can be fully expanded in the radial direction.
- the other end of the release member 640 passes through the small channel hole 401 of the push rod 400 and is fixed to the tail end handle 500 of the conveying device.
- the tail end handle has a built-in groove structure to connect the metal rod or metal wire to achieve the effect of pulling the metal rod or metal wire.
- the semi-release structure further includes a restraint 650.
- the restraint 650 is a double-layer polymer material wire.
- the upper part of the stent 600 is fixed between the wire buckles 630 with a double-layer polymer material wire.
- one side of the stent 600 is fixed with a double-layer polymer material wire, and the wire buckle 630 is located between the crest and the trough of the metal skeleton 140.
- the two ends of the double-layer polymer material wire pass through the remaining wire buckles 630 and are fixed to the release member 640, that is, fixed to a movable metal rod or wire, so that the stent 600 is radially compressed by the polymer material wire 650 and is in a semi-constrained state.
- the semi-release structure of the stent is not limited to this.
- one or more release members 640 can be provided as needed.
- the metal rod or wire of the release member 640 can be connected to the traction wire. They respectively pass through different small channel holes 401 on the push rod 400.
- the release members 640 are provided on both sides of the stent and respectively pass through the small channel holes 401 on both sides of the push rod 400. At this time, the traction wire can be provided on the small curved side of the stent.
- This setting not only avoids the interference problem caused by the metal rod or metal wire being provided on the small curved side. At the same time, it avoids the problem of a longer path, greater resistance, and disadvantageous release caused by the metal rod or metal wire being provided on the large curved side. Therefore, it is optimal to provide the metal rod or metal wire on both sides of the stent.
- the structure and connection relationship of the sheath-core assembly 100 and the traction wire 200 will be exemplified below.
- the following structure and connection method can be combined with the structure of any of the above-mentioned delivery systems, as long as the distal end of the sheath-core assembly 100 can be bent by pulling the traction wire 200 without affecting the normal release of the stent.
- the sheath core component 100 includes an inner sheath core component 101 and/or an outer sheath core component 102. That is, there are multiple situations in which the sheath core component 100 includes an inner sheath core component 101; or the sheath core component 100 includes an outer sheath core component 102; or the sheath core component 100 includes both the inner sheath core component 101 and the outer sheath core component 102.
- the distal end of the traction wire 200 is connected to the distal end of the inner sheath core component 101 and/or the distal end of the outer sheath core component 102.
- the distal end of the traction wire 200 is only connected to the distal end of the inner sheath core component 101; or the distal end of the traction wire 200 is only connected to the distal end of the outer sheath core component 102; or the distal end of the traction wire 200 is simultaneously connected to the distal end of the inner sheath core component 101 and the distal end of the outer sheath core component 102.
- the traction wire 200 is connected to at least one of the inner sheath core component 101 and the outer sheath core component 102. This embodiment only exemplifies the case where the sheath core component 100 includes both the inner sheath core component 101 and the outer sheath core component 102.
- the sheath core component 100 only includes the inner sheath core component 101 or the outer sheath core component 102
- the structures of the inner sheath core component 101 and the outer sheath core component 102 and the connection method with the traction wire 200 can all refer to the following embodiments.
- the sheath core component 100 of the present embodiment includes an inner sheath core component 101 and an outer sheath core component 102 at the same time, and the inner sheath core component 101 and the outer sheath core component 102 are at least partially sleeved, wherein the outer sheath core component 102 is outside, the inner sheath core component 101 is inside, the distal end of the inner sheath core component 101 is closer to the distal end of the conveying system, and the outer sheath core component 102 can move axially relative to the inner sheath core component 101, and the distal end of the traction wire 200 is connected to the distal end of the inner sheath core component 101 and/or the distal end of the outer sheath core component 102.
- distal end of the traction wire 200 of the present embodiment is connected to the distal end of the inner sheath core component 101 and/or the distal end of the outer sheath core component 102, which can be directly connected or indirectly connected through other components.
- the inner sheath core assembly 101 includes an inner sheath core tube 101a, a guide head 101b fixedly arranged at the distal end of the inner sheath core tube 101a, and a barb 101c arranged at the proximal end of the guide head 101b.
- a guide wire cavity (not shown) is provided in the inner axial direction for guide wire to pass.
- the inner sheath core tube 101a, the guide head 101b and the barb 101c can be connected as one by bonding, injection molding, welding and other modes.
- the proximal end of the inner sheath core tube 101a is fixed inside the handle 500, and the inner sheath core tube 101a cannot move axially relative to the handle 500.
- the traction wire 200 can be connected to one of the inner sheath core tube 101a, the guide head 101b and the barb 101c or any two or three.
- the connection mode is not limited to welding, bonding or other modes to fix directly or indirectly.
- the bending adjustment can directly act on the guide head 101b, so that the guide head 101b is bent.
- traction wire 200 is connected with barb 101c, because far-end barb 101c is usually made of metal-like high strength material, therefore, the connection force of traction wire 200 and barb 101c is stronger, and the position of far-end connection can bear greater pulling force.
- guide head 101b has certain flexibility, can conform to blood vessel bending, and can also be made into pre-bending state.
- Barb 101c is preferably rounded barb. Rounded barb 101c and the anchor 102b of outer sheath core assembly 102 cooperate to make interventional instrument detachable and connected with sheath core assembly 100, bare stent 610a on stent 600 far-end can be hooked on anchor 102b, by pulling outer sheath core assembly 102 back, barb 101c blocks stent, and stent 600 previously hooked on anchor 102b can be separated from outer sheath core assembly 100.
- the barb 101c includes a connecting portion 101c1 connected to the proximal end of the guide head 101b and a limiting portion 101c2 connected to the proximal end of the connecting portion 101c1, and the limiting portion 101c2 radially protrudes from the connecting portion 101c1.
- a recessed portion for the anchor 102b to pass through is concavely provided on the outer circumferential surface of the protruding portion of the limiting portion 101c2, and a protruding portion for blocking is formed between adjacent recessed portions.
- a through hole 101c21 is axially provided on the raised portion of the protruding connecting portion 101c1 of the limiting portion 101c2, and the traction wire 200 passes through the through hole 101c21 and is connected to the barb 101c.
- the traction wire 200 passes through the through hole 101c21 and is hooked on the connecting portion 101c1, or the traction wire 200 passes through the through hole 101c21 and a blocking member having a diameter larger than the through hole 101c21 is formed at the end of the traction wire 200, thereby achieving connection.
- the through hole 101c21 is provided on the raised portion, which can not only achieve connection, but also avoid affecting the release of the bare stent.
- a pulley structure 101d is provided in the recessed portion, and the traction wire 200 is hooked on the connecting portion 101c1 through a metal ring and then passes through the pulley structure 101d.
- This structure can change the direction of the force when providing traction force, so that the traction force originally along the axial direction of the conveying system is converted into a radial pulling force on the rounded barb, which can greatly reduce the traction force required to be provided and reduce the tension of the traction wire 200 when subjected to force, thereby reducing the risk of cutting the stent.
- the outer sheath core assembly 102 includes a sleeve disposed outside the inner sheath core tube 101a.
- the connection method includes but is not limited to welding, bonding or other methods to directly or indirectly fix.
- the outer sheath core tube 102a is a hollow structure, and the middle channel can be inserted into the inner sheath core tube 101a.
- the outer sheath core tube 102a includes a flexible hollow tube 102a1 and a rigid hollow tube 102a2.
- the anchor 102b is a metal part.
- the anchor 102b, the flexible hollow tube 102a1 and the rigid hollow tube 102a2 can be connected as a whole by bonding, injection molding and welding, etc.
- the proximal end of the rigid hollow tube 102a2 is connected to the inside of the handle 500, and a space is reserved for pulling the outer sheath core tube 102a backward.
- the anchor 102b includes an anchoring body 102b1 connected to the distal end of the outer sheath core tube 102a and a stent fixing rod 102b2 arranged at the distal end of the anchoring body 102b1.
- a plurality of stent fixing rods 102b2 are arranged at intervals along the circumference of the anchoring body 102b1, and there are gaps between the connected stent fixing rods 102b2 that can accommodate a bare stent.
- sheath core assembly 100 comprises inner sheath core tube 101a, guide head 101b, barb 101c, outer sheath core tube 102a and anchor 102b
- traction wire 200 can be connected with any one of them, certainly, in order to improve the reliability of connection, also can be connected with multiple thereof, multiple refers to two and more than two.
- traction wire 200 can not be connected with inner sheath core tube 101a at this moment, and select to be connected with other.
- select to connect traction wire 200 with barb 101c and/or guide head 101b reason is, on the one hand, the action force applied can directly act on the outer sheath core assembly closer to the far end, can realize adjustment quickly.On the other hand, even if support has broken away from anchor 102b or is in half-detached state, still can directly pull the inner sheath core assembly to
- the traction wire 200 can be connected to the inner sheath core component 101 by passing through the outer sheath core component 102.
- the connection method includes but is not limited to welding, bonding or other methods of direct or indirect fixation.
- the distal end of the traction wire 200 passes through the gap between the stent fixing rod 102b2 of the anchor 102b and is connected only to the barb 101c, so that the distal end of the sheath core assembly can be bent during the semi-release process of the stent, and the bare stent, which is hooked on the stent fixing rod 102b2, will not have any effect on the release of the stent 600.
- the distal end of the traction wire 200 can also be extended to extend into the guide head 101b and connected to the guide head 101b.
- the traction wire 200 can be placed in the first gap w1 between the sheath core component 100 and the outer sheath tube 300, and after the traction wire 200 is placed in the first gap w1, the distal end of the traction wire 200 is connected to the distal end of the sheath core component 100, and the traction wire 200 can move in the first gap w1, and the proximal end of the traction wire 200 is extended and connected to the handle 500, and the traction wire 200 is pulled by the handle 500.
- the tube wall of the outer sheath tube 300 is provided with a first limiting channel (not shown) in the axial direction.
- a first limiting channel (not shown) in the axial direction.
- the traction wire 200 can be placed in a second gap w2 between the sheath-core assembly 100 and the push rod 400.
- the distal end of the traction wire 200 is connected to the distal end of the sheath-core assembly 100, and the traction wire 200 can move in the second gap.
- the proximal end of the traction wire 200 extends and is connected to the handle 500, and the traction wire 200 is pulled by the handle 500.
- a second limiting channel is axially provided on the tube wall of the push rod 400, for example, the small channel hole 401 mentioned above, the traction wire 200 can be placed in the second limiting channel and the distal end is connected to the distal end of the sheath core assembly 100, the traction wire 200 can move in the second limiting channel, the proximal end of the traction wire 200 passes through the second limiting channel and is connected to the handle 500, and the traction wire 200 is pulled by the handle 500.
- the push rod 400 has a certain hardness, which can control the path of the traction wire 200, and prevent the path of the free traction wire 200 from changing during the bending process, thereby causing the bending angle to change. At the same time, it prevents the traction wire 200 from being entangled on the sheath core assembly during the bending process.
- the traction wire 200 is offset, preferably, the traction wire 200 is located on the side of the small bend, which can control the bending direction of the conveying system.
- the small channel hole 401 into which the traction wire 200 and the release member 640 enter should be located at different sides. It should be noted that in order to avoid affecting the release of the stent 600, the traction wire 200 passes through the inside of the stent 600 at a section where the stent 600 is provided.
- the distal end of the traction wire in this embodiment is connected to the distal end of the sheath-core assembly. Pulling the proximal end of the traction wire can at least bend the distal end of the sheath-core assembly relative to its axis. By adjusting the bending angle of the front end of the delivery system, the stent can reach the curved part smoothly, and the front end of the stent can be located in the middle of the aortic arch when released, thereby reducing the "bird's beak" effect.
- this embodiment further proposes an anti-entanglement and anti-cutting delivery system based on the above-mentioned overall delivery system or the delivery system of the first embodiment.
- the delivery system of this embodiment further includes a fixing member 700 on the basis of the above. That is, the delivery system of this embodiment includes an adjustable bending member with a preset axial length, a traction wire 200 for pulling the adjustable bending member to bend under the action of tension, and a fixing member 700 fixed on the adjustable bending section of the adjustable bending member.
- the adjustable bending member includes an adjustable bending section 100a located at the distal end, and the distal end of the traction wire 200 is connected to the distal end of the adjustable bending section 100a, which is used to pull the adjustable bending section 100a to bend under the action of an external force.
- the adjustable bending member of this embodiment can select the sheath core component 100 as described in Example 1, and the structure of the sheath core component 100 can refer to the above-mentioned Example 1. It should be known that if it is only based on the purpose of anti-winding and cutting, the adjustable bending member of this embodiment is not limited to the sheath core component 100.
- the fixing member 700 of this embodiment is provided with m pieces, 1 ⁇ m and m is a natural number, and the m fixing members 700 are arranged at intervals along the axial direction of the adjustable curved section 100a, and the interval distance of the fixing members 700 can be set as required.
- the fixing member 700 is provided with a traction channel 710 for the traction wire 200 to pass through, and the traction wire 200 can move axially relative to the fixing member 700. After passing through the traction channel 710, the traction wire 200 is connected to the adjustable curved section 100a of the adjustable curved member and forms an initial traction point at the connection.
- the traction wire 200 of this embodiment passes through the traction channel 710 of the fixing member 700, which not only prevents the traction wire 200 from being entangled, but also limits the curved path of the adjustable curved member, thereby avoiding cutting damage to the stent or blood vessel during the traction process.
- the fixing member 700 can be fixed on one side of the outer wall of the adjustable bending section 100a of the adjustable bending member, and when the traction wire 200 passes through the traction channel 710 of the fixing member 700 and the small channel hole 401 on the push rod 400 at the same time, the traction channel 710 on the fixing member 700 is opposite to the small channel hole 401 on the push rod 400.
- the columnar fixing member 700a is arranged around the sheath core component 100, and the columnar fixing member 700a is fixedly sleeved on the outer side of the adjustable bending section 100a.
- the shape and axial length of the fixing member 700 can be set as required.
- a rod-shaped fixing member 700b with a longer axial length can be set.
- a column-shaped fixing member 700a with a shorter axial length can also be set. It can also be a thin film attached to the outside of the adjustable bending section 100a.
- a fixing part, such as fixing part 700, can be formed by a polymer film, which is fixed to the outside of the adjustable bending section 100a by heat shrinkage or bonding, and a traction channel 710 through which the traction wire 200 can pass is designed between the film and the outer wall of the adjustable bending section 100a.
- m fixing members are arranged at intervals along the axial direction of the adjustable bending section 100a, and the m fixing members arranged at intervals are the first fixing member, the second fixing member, and the m fixing members are arranged at intervals from the distal end to the proximal end of the adjustable bending member.
- the m fixing members divide the adjustable bending section 100a into m+1 adjustable bending sub-segments, and the m+1 adjustable bending sub-segments are the first sub-segment, the second sub-segment, and the m+1 sub-segment from the distal end to the proximal end of the adjustable bending member.
- Each sub-segment has an effective bending length.
- the effective bending length described in the present invention includes the distance between the first fixing member and the distal end of the adjustable bending section 100a (i.e., D1 in FIG20), the distance between the m fixing member and the proximal end of the adjustable bending section 100a (i.e., Dm+1 in FIG20), and the distance between two adjacent fixing members (i.e., the effective bending length of each sub-segment between D1 and Dm+1 in the figure). As shown in FIG.
- the effective bending length of the first sub-segment is D1
- the effective bending length of the second sub-segment is D2
- the effective bending length of the third sub-segment is D3
- the effective bending length of the fourth sub-segment is D4, and so on
- the effective bending length of the m+1 sub-segment is Dm+1.
- one of the sub-segments is used to be opposite to the aortic arch, and the sub-segment opposite to the aortic arch has the largest effective bending length.
- the first sub-segment or the second sub-segment is used to be opposite to the aortic arch, and the first sub-segment or the second sub-segment has the largest effective bending length.
- the selection range of the maximum effective bending length is 42mm to 66mm, and the effective bending length range of other sub-segments is 31mm to 56mm.
- the m+1th sub-segment has the smallest effective bending length, and preferably the effective bending length of the m+1th sub-segment is not greater than 20mm, at which time the bending angle of the m+1th sub-segment is extremely small.
- Figure 15 and Figure 22 respectively show the morphology of the delivery system without a fixing and the delivery system with a fixing when bending in the blood vessel.
- the first sub-segment is used to face the aortic arch and has the largest effective bending length, that is, D1 is the largest. Therefore, the bending of the first sub-segment is the most obvious, and the bending degree of the remaining sub-segments is smaller than that of the first sub-segment.
- the m+1 sub-segment is bent only because it conforms to the blood vessel, and the delivery system provides almost no bending force.
- This embodiment uses a fixing member to limit the traction wire to prevent the traction wire from being entangled and avoids cutting damage to the traction wire stent or blood vessel during the traction process.
- the adjustable bending member is a sheath core component
- the bending angle of the front end of the delivery system can be adjusted, which allows the stent to reach the curved part smoothly and also allows the front end of the stent to be located in the middle of the aortic arch when released, reducing the "bird's beak” effect and allowing the interventional device to be placed more accurately.
- Embodiment 3 (blocking member)
- the delivery system of the above-mentioned second embodiment prevents the traction wire 200 from being entangled by limiting the fixing member 700, and avoids cutting damage to the stent or blood vessel during the pulling process.
- the problem is that, as shown in FIG22, when the traction wire 200 is pulling the distal end of the adjustable bending member, if the pulling force is not well controlled, it is easy to cause excessive pulling, causing the distal end of the adjustable bending member to pierce the blood vessel wall, which is high-risk and requires high control of pulling.
- this embodiment based on the second embodiment, further proposes a solution for controlling the bending of the adjustable bending section of the adjustable bending member in sections.
- this embodiment proposes a segmented bending conveying system, and the conveying system of this embodiment further includes a blocking member 800 on the basis of the second embodiment. That is, the conveying system of this embodiment includes an adjustable bending member with a preset axial length, a traction wire 200 for pulling the adjustable bending member to bend under the action of tension, a fixing member 700 fixed on the adjustable bending section 100a of the adjustable bending member, and a blocking member 800 fixed on the traction wire.
- the fixing member 700 and the blocking member 800 together constitute a bending control assembly for realizing segmented bending of the adjustable bending member 100.
- the adjustable bending member includes an adjustable bending section 100a located at the distal end, and the distal end of the traction wire 200 is connected to the distal end of the adjustable bending section 100a, and is used to pull the adjustable bending section 100a to bend under the action of an external force.
- the specific structure and connection method of the adjustable bending member and the traction wire 200 refer to the above-mentioned overall conveying system or embodiment one or embodiment two, and will not be repeated here.
- the adjustable bending member of this embodiment can be selected as the sheath-core assembly 100 described in Example 1, and the structure of the sheath-core assembly 100 can refer to the above-mentioned Example 1. It should be known that if it is only based on the purpose of segmented bending control, the adjustable bending member of this embodiment is not limited to the sheath-core assembly 100.
- the fixing member 700 is fixed on the adjustable bending section 100a
- the blocking member 800 is fixed on the traction wire 200
- the fixing member 700 is provided with a traction channel 710 for the traction wire to pass through
- the traction wire passes through the traction channel 710 and its distal end is connected to the distal end of the adjustable bending section 100a and forms an initial traction point at the connection
- a preset spacing is provided between the blocking member 800 and the fixing member 700 adjacent to the proximal side thereof; in the process of pulling the traction wire 200, the blocking member 800 can reduce the preset spacing with the movement of the traction wire 200 until it abuts against the fixing member 700 and forms a new traction point at the abutment of the two.
- the blocking member 800 contacts the fixing member 700, even if the pulling force increases (referring to not reaching the preset maximum pulling force), it will not continue to bend, which is conducive to controlling the maximum bending degree of the adjustable bending member.
- a blocking member 800 is provided on the traction wire 200.
- the blocking member 800 In a natural state where the traction wire 200 is not pulled, the blocking member 800 is at a preset distance from the fixing member 700. During the pulling process, the blocking member 800 can be abutted against the fixing member 700, so that the fixing member 700 axially limits the blocking member 800 to form a new pulling point, thereby avoiding excessive pulling on the distal end of the sheath assembly 100 and preventing the distal end of the adjustable bending member from piercing the blood vessel wall due to excessive bending.
- FIG. 23 there are m fixing members 700, 1 ⁇ m and m is a natural number, and the m fixing members 700 are arranged at intervals along the axial direction of the adjustable bending section 100a.
- the arrangement of the m fixing members 700 refers to the above-mentioned embodiment 2, which will not be repeated here. Continuing to refer to FIG. 23 , there are m fixing members 700, 1 ⁇ m and m is a natural number, and the m fixing members 700 are arranged at intervals along the axial direction of the adjustable bending section 100a.
- the arrangement of the m fixing members 700 refers to the above-mentioned embodiment 2, which will not be repeated here. Continuing to refer to FIG.
- n blocking members 800 there are n blocking members 800 in this embodiment, 1 ⁇ n and n is a natural number, and the n blocking members 800 are arranged at intervals along the axial direction of the traction wire 200; the n blocking members 800 can be selectively spaced at intervals on the distal side of the m fixing members 700, so that the blocking member 800 can abut against the fixing member 700 adjacent to its proximal side as the traction wire 200 moves and form a new pulling point at the abutment between the two.
- the n blocking members 800 correspond to n of the m fixing members 700, respectively, so that each blocking member 800 has a fixing member 700 adjacent to it on the proximal side, and there is a preset spacing between each blocking member 800 and the fixing member 700 adjacent to it on the proximal side, thereby forming n preset spacings, and the sizes of the n preset spacings are equal or unequal.
- the n blocking members 800 match the m fixing members 700 one by one, so that each blocking member 800 has a fixing member 700 adjacent to it on the proximal side, and there is a preset spacing between each blocking member 800 and the fixing member 700 adjacent to it on the proximal side, thereby forming n preset spacings, and the sizes of the n preset spacings are equal or unequal.
- the fixing member 700 in this embodiment not only prevents the traction wire 200 from being entangled, thus avoiding cutting damage to the stent or blood vessel during the pulling process, but can also be used to cooperate with the blocking member 800 to achieve segmented bending of the adjustable bending member.
- the n preset spacings are L1, L2, ..., Ln from far to near, and the n preset spacings gradually increase from far to near, that is, L1 ⁇ L2 ⁇ ... ⁇ Ln, so that in the process of pulling the traction wire 200, the n blocking members 800 can abut against the fixing members 700 adjacent to its proximal side in turn as the traction wire 200 moves, and n new pulling points are formed in turn at the abutment.
- the spacing between the multiple blocking members 800 and the fixing member 700 closest to its proximal side gradually increases in turn, so that during the pulling process, multiple pulling points can be formed in the axial direction in turn, which not only avoids excessive pulling on the distal end of the sheath tube assembly 100, but also realizes the step-by-step segmented bending control of the sheath core assembly 100 in the axial direction.
- the D1 area is first subjected to force and bends.
- the degree of bending reaches the maximum value, the blocking member 800 Contact with the fixing member 700.
- the shape of the blocking member 800 includes but is not limited to a spherical shape, and/or a cylindrical shape, and/or an ellipsoidal spherical shape, and/or a conical shape, etc. It is only necessary to control the blocking member 800 and the fixing member 700 to abut against each other. More preferably, a limiting groove is provided on one of the fixing member 700 and the blocking member 800, so that the other one can be fully or partially embedded in the limiting groove when abutting. For example, as shown in FIG. 25 , a limiting groove 720 is provided on the fixing member 700, and the limiting groove 720 is connected with the traction channel 710. When abutting, the blocking member 800 can be embedded in the limiting groove, so that the stability of the connection is better.
- the blocking member 800 and the fixing member 700 are in elastic contact when they are in contact.
- the elastic contact structure can make the operator feel whether a certain section is close to the bending limit as the force required for squeezing increases, so that the operator can better control it and will not apply tension all at once to puncture the blood vessel.
- the tension increases, the next contact point may form a pulling point.
- the elastic contact allows the bending to rebound, which can better control the bending angle.
- the proximal side of the blocking member 800 and/or the distal side of the fixing member 700 are provided with an axially compressible elastic portion.
- the elastic portion is a spring, a torsion spring or a flexible rubber member.
- the fixing member is a coil spring 700c that can be sleeved on the adjustable curved section 100a and the proximal side is relatively fixed to the adjustable curved section 100a.
- the inner diameter of the coil spring 700c is greater than the outer diameter of the adjustable curved section 100a, so that the fixing member 700 can be sleeved on the adjustable curved section 100a.
- This design not only realizes elastic abutment, but also allows the thickness of the coil spring to be designed to be thinner, thereby reducing the overall outer diameter of the adjustable curved member, so that the interventional device has more space in the conveying system.
- the blocking member 800 can pass through the traction channel 710 on the fixing member 700 when the pulling force on the traction wire 700 exceeds the preset pulling force.
- the fixing member 700 and the contact position of the blocking member 800 form an extrusion force.
- the blocking member 800 passes through the traction channel 710 on the fixing member 700, and the traction wire 200 is continuously pulled to make the adjustable bending section at the far end of the fixing member 700 continue to bend, that is, by controlling the magnitude of the pulling force, the blocking member 800 can be controlled to pass through the fixing member 700 or not, and the bending of the previous section can be controlled when not passing through, and the control can be continued after passing through, thereby increasing the controllable length.
- a certain blocking member can be further set to pass through only one or two fixing members, and when the fixing member that cannot pass through abuts, a fixed pulling point can still be formed.
- a spring 701 and a movable member 702 are provided in the traction channel 710 of the fixing member 700, and the movable member 702 can be raised or lowered with the spring 701.
- the spring 701 is compressed.
- the spring 701 When the pulling force is large enough, the spring 701 is compressed to a level sufficient for the blocking member 800 to pass through, and the blocking member 800 can pass through the traction channel 710 of the fixing member 700, thereby abutting against the next fixing member 700 again to form a new pulling point.
- a rubber member 703 with a slope is provided in the traction channel 710 of the fixing member 700. Since the rubber member 703 is elastic, when the pulling force is large enough to compress the rubber member 703 to a level sufficient for the blocking member 800 to pass through, the blocking member 800 can pass through, thereby forming a new pulling point.
- This embodiment realizes segmented bending control by setting a fixing member 700 on the adjustable bending section and setting a blocking member 800 on the traction wire 200, so that each position of the traction wire 200 is bent in place, and the situation that the distal end of the traction wire 200 is bent too much can be avoided. Further, when the blocking member 800 and the fixing member 700 of this embodiment are elastically abutted, when the force of pulling the traction wire 200 is large enough, the blocking member 800 can pass through the traction channel 710 on the fixing member 700, and the blocking member 800 can be pulled to the proximal side of the fixing member 700 corresponding to it, so that the corresponding adjustable bending section can continue to bend under the action of the traction wire 200.
- the elastic abutment structure can make the operator feel whether a certain section is close to the bending limit as the force required for squeezing increases, and can better control it, so as not to cause the pulling force to be applied all at once to puncture the blood vessel.
- Embodiment 4 (bending control sleeve)
- the conveying system of the third embodiment above realizes segmented bending control, but the segmented bending control is formed by the fixing member 700 and the blocking member 800 abutting against each other to form a limit.
- the problem is that after the conveying system is manufactured, the sequence of segmented bending control can only be carried out from far to near and the bending adjustment method is fixed, and it is impossible to adjust the bending of each section more flexibly according to actual needs.
- this embodiment further proposes a solution for flexibly controlling the bending of the adjustable bending section 100a of the adjustable bending member on the basis of the above-mentioned overall conveying system or the conveying system of the first embodiment or the conveying system of the second embodiment.
- this embodiment proposes a controllable bend delivery system, which includes an adjustable bend member with a preset axial length, a traction wire 200 for pulling the adjustable bend member to bend under the action of tension, and a bend control assembly for controlling the degree of bending of the adjustable bend member.
- the adjustable bend member includes an adjustable bend section 100a located at the distal end; the distal end of the traction wire 200 is connected to the distal end of the adjustable bend section 100a, and is used to pull the adjustable bend section 100a to bend under the action of an external force.
- the specific structures of the adjustable bend member and the traction wire 200 are as follows: For the connection method, please refer to the above-mentioned overall conveying system or embodiment 1 or embodiment 2, which will not be repeated here.
- the adjustable bending component of this embodiment can be selected as the sheath core assembly 100 described in embodiment 1, and the structure of the sheath core assembly 100 can refer to the above-mentioned embodiment 1. It should be known that if it is only based on the purpose of flexible bending control, the adjustable bending component of this embodiment is not limited to the sheath core assembly 100.
- the bending control assembly of this embodiment includes a bending control sleeve 900 sleeved on the traction wire 200 opposite to the adjustable bending section 100a, and the bending control sleeve 900 is movably sleeved on the traction wire 200, so that the bending control sleeve 900 can move axially relative to the bending control sleeve 900 on the traction wire 200.
- the effective bending length here refers to the effective bendable length within the adjustable bending section 100a. For example, if other non-adjustable bending parts are set on the adjustable bending section 100a, the length of this part needs to be removed.
- the bending control sleeve 900 may be an inflexible rigid sleeve or a flexible elastic sleeve. That is, the p bending control sleeves 900 include a rigid sleeve that cannot undergo axial deformation and/or an elastic sleeve that can undergo axial deformation. It should be known that when there are multiple bending control sleeves 900, the multiple bending control sleeves 900 may be partially rigid sleeves and partially elastic sleeves. Multiple refers to two or more. Preferably, if there are at least two elastic sleeves in the p bending control sleeves 900, the elastic stiffness coefficients of the two elastic sleeves are the same or different. When the elastic stiffness coefficients of the two elastic sleeves are different, the elastic stiffness coefficients of the two elastic sleeves increase from far to near.
- the bending control assembly of this embodiment also includes a fixing member 700 fixed on the adjustable bending section 100a, and the fixing members 700 are provided with m pieces, 1 ⁇ m and m is a natural number, and the m fixing members 700 are arranged at intervals along the axial direction of the adjustable bending section 100a, and the m intervally arranged fixing members 700 divide the adjustable bending section 100a into m+1 adjustable bending sub-segments; the fixing member 700 is provided with a traction channel for the traction wire 200 to pass through, and the distal end of the traction wire 200 passes through the traction channel and is connected to the distal end of the adjustable bending section 100a; wherein, 1 ⁇ p ⁇ m+1, the p bending control sleeves 900 can be selectively arranged one by one with the p sub-segments in the m+1 sub-segments, and the axial length of each bending control sleeve 900 is not greater than the effective bending length
- the arrangement of the fixing member 700 of this embodiment can be referred to the second embodiment, and will not be repeated here. It can be understood that when the present embodiment includes a fixing member 700, the effective bending length described herein includes the distance between the first fixing member and the distal end of the adjustable bending section 100a, the distance between the mth fixing member and the proximal end of the adjustable bending section 100a, and the distance between two adjacent fixing members.
- the m+1 adjustable bending sub-segments are the first sub-segment, the second sub-segment, and the m+1th sub-segment from the distal end to the proximal end of the adjustable bending member; wherein, among the m+1 adjustable bending sub-segments, one sub-segment is used to face the aortic arch.
- the sub-segment facing the aortic arch has the largest effective bending length;
- One of the bending sleeves 900 is sleeved on the traction wire 200 opposite to the sub-segment with the maximum effective bending length.
- the second sub-segment is used to be opposite to the aortic arch, and the second sub-segment has the maximum effective bending length, and one of the bending sleeves 900 is sleeved on the traction wire 200 opposite to the second sub-segment.
- the m+1 sub-segment has the minimum effective bending length.
- the effective bending length of the m+1 sub-segment is not greater than 20 mm.
- the fixing member 700 includes a coil spring, which is sleeved on the adjustable curved section 100a and at least partially fixed to the adjustable curved section 100a, and a traction channel for the traction wire 200 to pass through is provided between the adjustable curved section 100a and the coil spring.
- the inner diameter of the coil spring is larger than the outer diameter of the adjustable curved section 100a, so that the fixing member 700 can be sleeved on the adjustable curved section 100a.
- This design not only realizes elastic abutment, but also allows the thickness of the coil spring to be designed to be thinner, reducing the overall outer diameter of the adjustable curved member, so that the interventional device has more space in the delivery system.
- the bending control sleeve includes a rigid sleeve 900a, and the rigid sleeve can be made of metal, such as stainless steel.
- the traction wire 200 passes through the rigid sleeve and can be displaced with the rigid sleeve.
- the length of the rigid sleeve is L, satisfying L ⁇ D2, wherein D2 is the effective bending length of the second sub-segment. It can be understood that the length of L determines the maximum degree of bendability of the D2 region. The shorter L, the greater the degree of bendability of the D2 region.
- the effective bending length of the D2 region is the largest, so the D2 region is preferentially bent, and the remaining regions do not bend significantly at the beginning.
- the pulling force continues to increase, the remaining regions also bend accordingly.
- the maximum bending degree of the D2 region is limited by L, in the process of continuously increasing the pulling force, the D2 region does not continue to bend after reaching the maximum bending degree, and the remaining regions can still continue to bend, achieving a flexible segmented bending effect.
- FIG32 is a schematic diagram of one application scenario of the delivery system in human blood vessels, where the D2 region is located at the aortic arch and the D1 region is located at the ascending aorta.
- the degree of curvature of the D2 region can be adjusted first to bring the stent hooked on the sheath core assembly closer to the lesser curvature.
- the D2 region reaches the designed curvature, further adjustment can be made to bend the D1 region, further adjusting the proximal end of the stent and the wall adhesion of the blood vessel.
- the D1, D2....Dm+1 regions can be designed according to actual needs, and the rigid channel 300 can also be selectively designed in each region according to actual needs.
- the maximum compression of the spring sleeve is ⁇ L
- the spring sleeve design can cover the traction wire in the entire area, effectively avoiding the damage to human blood vessels caused by the exposed traction wire.
- the spring has restorative properties and can restore its original shape after compression. Therefore, when the pulling force is removed, the D2 area can be restored to its original shape. shape, which is conducive to the withdrawal of the conveying system.
- a bending control sleeve 900 includes q sub-sleeves arranged in sequence along the axial direction of the traction wire 200, 1 ⁇ q and q is a natural number, the q sub-sleeves are connected or not connected, and the sum of the axial lengths of the q sub-sleeves is not greater than the effective bending length of the adjustable bending section 100a corresponding thereto.
- the sub-sleeve may be a sub-rigid sleeve that cannot be axially deformed and/or a sub-elastic sleeve that can be axially deformed.
- the sub-sleeve may be a sub-rigid sleeve that cannot be axially deformed, the sum of the lengths of all sub-sleeves in the same area is the corresponding curve chord length at the maximum bending angle of the area.
- the elastic stiffness coefficients of the two sub-elastic sleeves are the same or different.
- the elastic stiffness coefficients of the two sub-elastic sleeves increase from far to near.
- sub-elastic sleeves there are three sections of sub-elastic sleeves (or multiple sections) in the same area, and the following sections are represented by 901, 902, and 903, respectively.
- the stiffness coefficients of each section of the sub-elastic sleeve are represented by K1, K2, and K3, respectively. K1, K2, and K3 are not completely equal.
- different sub-elastic sleeve lengths and stiffness coefficients can be selected according to different vascular morphologies, and a bending curve that conforms to the vascular morphology can be set in the same area with reference to this method.
- the sub-elastic sleeves with different stiffness coefficients can be arranged continuously, that is, the sub-elastic sleeves are connected to form an elastic sleeve, and different sections of the elastic sleeve have different stiffness coefficients.
- the function of segmented bending adjustment can be achieved by only putting the elastic sleeve on the traction wire.
- the bending control assembly also includes a blocking member 800 fixed on the traction wire 200.
- the structure and setting method of the blocking member 800 can refer to the above-mentioned embodiment 2.
- the segmented bending control is achieved through the abutment between the blocking member 800 and the fixing member 700, and the bending control sleeve and other methods, thereby improving the flexibility and accuracy of the bending control.
- Embodiment 5 (multiple traction wires 200)
- the present embodiment provides an adjustable bending conveying system, comprising an adjustable bending member having a preset axial length and a traction wire 200 for pulling the adjustable bending member to bend under the action of tension;
- the adjustable bending member comprises an adjustable bending section 100a at the distal end, and the adjustable bending section 100a is provided with a plurality of traction points 110, and the traction points 110 at least include r axial traction points 110a arranged at intervals along the axial direction of the adjustable bending section 100a, 2 ⁇ r and r is a natural number;
- the traction wire 200 is provided with s roots, 2 ⁇ s and s is a natural number; wherein, r ⁇ s, the distal ends of r of the s traction wires 200 are respectively connected to r axial pulling points, and the s traction wires 200 are pulled to adjust the bending degree of the adjustable bending section 100a.
- the adjustable bending component of this embodiment can be selected as the sheath-core assembly 100 described in Example 1, and the structure of the sheath-core assembly 100 can refer to the above-mentioned Example 1. It should be known that if it is only based on the purpose of flexible bending control, the adjustable bending component of this embodiment is not limited to the sheath-core assembly 100.
- the r axial pulling points 110a spaced apart in the axial direction are not all located on the same longitudinal straight line, so that the projections of the r axial pulling points 110a in the axial direction perpendicular to the adjustable bending member do not completely overlap.
- the r axial pulling points 110a are all located on the small bending side of the adjustable bending member.
- the number of the traction wires 200 can be set to be greater than the number of the r axial traction points 110a.
- the adjustable bend section 100a further includes a circumferential traction point 110b located on the same circumference as the axial traction point 110a.
- the distal ends of the a traction wires 200 are respectively connected to the a circumferential traction points 110b.
- the a circumferential traction points 110b are all located on the small bend side of the adjustable bend member.
- the adjustable bend conveying system further includes a fixing member 700 fixedly mounted on the adjustable bend section 100a, and the fixing members 700 are provided in m numbers, 1 ⁇ m and m is a natural number, and the m fixing members 700 are arranged at intervals along the axial direction of the adjustable bend section 100a, and the fixing member 700 is provided with a traction channel through which the traction wire 200 can pass.
- the structure and arrangement of the fixing member 700 can refer to the second embodiment, and will not be described in detail here.
- the adjustable bend delivery system further includes a blocking member 800, wherein n blocking members 800 are provided, wherein 1 ⁇ n ⁇ s and n is a natural number, and n blocking members 800 can be selectively fixed on s traction wires 200, and n blocking members 800 are arranged at intervals along the axial direction; wherein one blocking member 800 is located at intervals on the distal side of a fixing member 700 and at the proximal side of a pulling point 110, so that the blocking member 800 can abut against the fixing member 700 adjacent to the proximal side thereof as the traction wire 200 moves and form a new pulling point 110 at the abutment between the two.
- the structure of the blocking member 800 and the matching method with the fixing member 700 can refer to the third embodiment, and will not be described in detail here.
- the adjustable bend member further includes a support section 100b connected to the proximal side of the adjustable bend section 100a
- the adjustable bend delivery system further includes a push rod 400 sleeved outside the support section 100b, and a second limiting channel for the traction wire 200 to pass through is axially provided on the tube wall of the push rod 400, that is, a small channel hole 401 in the figure, and t second limiting channels are provided, and the t second limiting channels are parallel to each other, wherein 1 ⁇ t ⁇ s and t is a natural number.
- the t second limiting channels are all located on the small bend side of the adjustable bend member.
- the adjustable bend conveying system also includes a bend control sleeve sleeved outside the traction wire 200 opposite to the adjustable bend section 100a, and the bend control sleeves are provided in p numbers, 1 ⁇ p and p is a natural number, and the sum of the axial lengths of the p bend control sleeves is not greater than the effective bending length of the adjustable bend section 100a, and the p bend control sleeves are used to further adjust the bending degree of the adjustable bend section 100a during the pulling process.
- the structure and setting method of the bend control sleeve can refer to the fourth embodiment, and will not be repeated here.
- the fixing member 700 is provided with a plurality of traction channels 710 to allow the traction wire 200 to pass through.
- the sheath-core assembly 100 is made of a soft polymer material, and the traction wires 210 and 220 are respectively provided with fixing points at the distal end, and are respectively fixed to different traction mechanisms at the proximal end after passing through the small channel hole 401 of the push rod 400.
- the push rod 400 may be provided with a plurality of small channel holes 401 on the small curved side, and each small channel hole 401 corresponds to a traction wire 200, or a plurality of independent channels may be provided in the small channel hole 401 on the small curved side of the push rod 400, and each independent channel corresponds to a traction wire 200.
- the area of the adjustable bend section 100a is the bend adjustment area. Since each traction wire 200 has a fixed point at the distal end, the 100a area can be bent under force. As shown in FIG. 34 , D1, D2....Dm+1 are all the distances between the two fixed ends of the traction wire 200. When Dm+1 ⁇ 20mm, the bending angle of the Dm+1 section is extremely small. When the traction wire 210 is pulled, as shown in FIG. 35 , the area of the adjustable bend section 100a is bent as a whole; when the traction wire 220 is pulled, as shown in FIG. 36 , the area of the adjustable bend section 100a except D1 is bent.
- the other two traction wires can be fixed on the same pulling mechanism and pulled at the same time. As shown in FIG37 , the two traction wires are fixed independently at their distal ends. After passing through the fixing parts, the two traction wires are integrated into the channel of the push rod through welding, bonding and other processes, and are fixed to the pulling mechanism at the distal end.
- FIG2 a plurality of traction wires are arranged on the conveying system, and each traction wire is fixed at the distal end, so that each section can have a different degree of bending effect.
- FIG38 shows the bending shape of the conveying system when the three traction wires 210, 220 and 230 are bent together.
- FIG39 shows the bending shape of the conveying system when the two traction wires 220 and 230 are bent together.
- FIG40 shows the bending shape of the conveying system when 230 is bent.
- the traction wires can be distributed on different sides. As shown in Figure 41, it is a cross-sectional view of the push rod 400. Similarly, the cross-sectional view of the fixing member 700 is consistent with the push rod, at least ensuring that the channels of the two traction wires are on the same horizontal line.
- 210 and 220 are two traction wires, respectively.
- the angle between the positions of the two traction wires is ⁇ , 0° ⁇ 180°.
- the purpose of this design is that when a single traction wire is pulled, the conveying system will bend in the direction of the traction wire design. When the two traction wires are pulled at the same time, the bending angle can be adjusted in space.
- the conveying system is provided with a plurality of traction wires, and according to actual needs, each section of the adjustable bending section 100a region can be bent in different degrees in different directions in space, which is more conducive to entering twisted blood vessels.
- the traction wire needs to have a certain tensile strength. If the tensile strength is insufficient, the traction wire is easily stretched, resulting in a loss of travel, or even being broken, resulting in loss of function.
- the tensile and fracture strength of the metal can be improved by a quenching process (heating to a certain temperature and then rapidly cooling).
- the delivery system of the present invention can adjust the bending angle of the front end of the delivery system, so that the stent can reach the bending part smoothly and the front end of the stent can be located in the middle of the aortic arch when released, thereby reducing the "bird's beak" effect.
- the setting of the limiter and the blocking member not only avoids the entanglement of the pulling member, but also controls the direction and segment of the bending adjustment, thereby achieving precise step-by-step segmented bending control.
- the setting of the bending control sleeve and multiple traction wires can make the bending adjustment method more flexible, improve the bending performance of the delivery system, and ensure that the interventional device can be accurately delivered and released to the preset position.
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Abstract
可调弯输送系统,包括具有预设轴向长度的可调弯构件以及用于在拉力作用下牵拉可调弯构件弯曲的牵引丝(200);可调弯构件包括位于远端的可调弯段(100a),可调弯段(100a)上设有多个牵拉点(110),牵拉点(110)至少包括沿可调弯段(100a)的轴向方向间隔设置的r个轴向牵拉点(110a),2≤r且r为自然数;牵引丝(200)设有s根,2≤s且s为自然数;其中,r≤s,s根牵引丝(200)中的r根的远端与r个轴向牵拉点(110a)分别连接,牵拉s根牵引丝(200)以调节可调弯段(100a)的弯曲程度。本发明提供的可调弯输送系统,旨在解决现有介入器械无法被精准放置的问题。
Description
本发明涉及介入医疗器械技术领域,尤其涉及一种可调弯输送系统。
主动脉疾病如主动脉瘤、主动脉夹层是最致命且治疗难度最高的血管外科疾病之一。传统的治疗方法通过外科手术,具有手术创伤大、病死率高的风险。近年来,发展了一种微创、简捷的介入手术方法,将覆膜支架植入病变血管处,覆膜支架紧贴于血管内壁,将血管病变部位与血流隔离。覆膜支架既能让血液正常流通,又能保护病变血管,有效地修复血管病变。重建主动脉弓部需要使用输送装置将支架输送至主动脉弓部并释放,由于导丝贴着主动脉弓的大弯侧,目前的输送装置在释放时需要贴着主动脉弓部的大弯侧进行释放,使得覆膜支架的近端在小弯侧存在无法紧密贴壁,呈现“鸟嘴”效应,使得介入器械无法被精准放置,导致内漏发生。
发明内容
基于此,本发明提供一种可调弯输送系统,旨在解决现有介入器械无法被精准放置的问题。
为达此目的,本发明采用以下技术方案:
本发明提供一种输送系统,包括用于将与之可拆卸连接的介入器械运送至预设位置的鞘芯组件以及用于在外力作用下牵拉所述鞘芯组件弯曲的牵引丝;所述鞘芯组件包括位于远端的可调弯段,所述牵引丝的远端与所述可调弯段相连,牵拉所述牵引丝可至少使所述可调弯段相对所述鞘芯组件的纵向中心轴弯曲。
在其中一个实施例中,所述鞘芯组件包括内鞘芯组件和/或外鞘芯组件,所述牵引丝的远端与所述内鞘芯组件的远端和/或所述外鞘芯组件的远端相连;其中,在所述鞘芯组件同时包括所述内鞘芯组件和所述外鞘芯组件时,所述内鞘芯组件与所述外鞘芯组件至少部分套设,且所述内鞘芯组件的远端更靠近所述输送系统的远端,所述外鞘芯组件可相对所述内鞘芯组件轴向移动。
在其中一个实施例中,所述内鞘芯组件包括内鞘芯管、固设于所述内鞘芯
管远端的引导头及固设于所述引导头近端末端的倒钩;在所述牵引丝的远端与所述内鞘芯组件的远端相连时,所述牵引丝的远端与所述内鞘芯管的远端、所述引导头和所述倒钩三者之中的至少一个相连。
在其中一个实施例中,所述倒钩包括连接于所述引导头近端的连接部及连接于所述连接部近端的限位部,所述限位部径向上凸出所述连接部;当所述牵引丝的远端与所述倒钩相连时,所述限位部的凸出所述连接部的部分上设有一轴向贯穿的连接孔,所述牵引丝可穿过所述连接孔与所述倒钩相连。
在其中一个实施例中,所述外鞘芯组件包括外鞘芯管及设于所述外鞘芯管远端的锚定件;在所述牵引丝的远端与所述外鞘芯组件的远端相连时,所述牵引丝的远端与所述外鞘芯管的远端和所述锚定件两者之中的至少一个相连。
在其中一个实施例中,所述输送系统还包括中空并套设于所述鞘芯组件外侧的外鞘管,所述鞘芯组件的远端更靠近所述输送系统的远端,所述外鞘管与所述鞘芯组件之间存在第一间隙,所述外鞘管可相对所述鞘芯组件轴向移动。
在其中一个实施例中,所述牵引丝可置于所述第一间隙内并在所述第一间隙内轴向移动;或者所述外鞘管的管壁上轴向上设有第一限位通道,所述牵引丝可置于所述第一限位通道内并在所述第一限位通道内轴向移动。
在其中一个实施例中,所述输送系统还包括设于所述鞘芯组件和所述外鞘管之间的所述第一间隙内的推杆,所述推杆与所述鞘芯组件之间存在第二间隙。
在其中一个实施例中,所述牵引丝可置于所述第二间隙内并在所述第二间隙内轴向移动;或者所述推杆的管壁上轴向上设有第二限位通道,所述牵引丝可置于所述第二限位通道内并在所述第二限位通道内轴向移动。
在其中一个实施例中,所述输送系统还包括固设于所述鞘芯组件的所述可调弯段上的固定件,所述固定件设有m个,其中,1≤m且m为自然数,m个所述固定件沿所述可调弯段的轴向方向间隔设置,所述固定件上设有可供所述牵引丝穿过的牵引通道,所述牵引丝可相对所述固定件轴向移动,所述牵引丝穿过所述牵引通道后与所述可调弯段相连并在相连处形成初始牵拉点。
在其中一个实施例中,所述输送系统还包括固设于所述牵引丝上的阻挡件,所述阻挡件与位于其近端侧相邻的所述固定件之间设有预设间距,在牵拉所述牵引丝的过程中,所述阻挡件可随所述牵引丝的移动与所述固定件相抵并在两者的抵接处形成新的牵拉点。
在其中一个实施例中,所述输送系统还包括套设于与所述可调弯段相对的
所述牵引丝上的控弯套,所述控弯套设有p个,1≤p且p为自然数,p个所述控弯套的轴向长度之和不大于所述可调弯段的有效弯曲长度,p个所述控弯套用于在牵拉过程中调节所述可调弯段的弯曲程度。
在其中一个实施例中,所述可调弯段上设有多个牵拉点,所述牵拉点至少包括沿所述可调弯段的轴向方向间隔设置的r个轴向连接点,2≤r且r为自然数;所述牵引丝设有s根,2≤s且s为自然数;其中,r≤s,s根所述牵引丝中的r根的远端与r个所述轴向连接点分别连接形成r个轴向牵拉点,牵拉s根所述牵引丝以调节所述可调弯段的弯曲程度。
本发明还提供一种可分段调弯输送系统,包括具有预设轴向长度的可调弯构件、用于在拉力作用下牵拉所述可调弯构件弯曲的牵引丝以及用于实现所述可调弯构件分段弯曲的控弯组件;其中,所述可调弯构件包括位于远端的可调弯段,所述控弯组件包括固设于所述可调弯段上的固定件以及固设于所述牵引丝上的阻挡件,所述固定件上设有可供所述牵引丝穿过的牵引通道,所述牵引丝的远端穿过所述牵引通道且与所述可调弯段的远端相连并在相连处形成初始牵拉点,所述阻挡件与位于其近端侧相邻的所述固定件之间设有预设间距;在牵拉所述牵引丝的过程中,所述阻挡件可随所述牵引丝的移动与所述固定件相抵并在两者的抵接处形成新的牵拉点。
在其中一个实施例中,所述固定件设有m个,1≤m且m为自然数,m个所述固定件沿所述可调弯段的轴向方向间隔设置;所述阻挡件设有n个,1≤n且n为自然数,n个所述阻挡件沿所述牵引丝的轴向方向间隔设置;n个所述阻挡件可选择性的间隔位于m个所述固定件的远端侧,使得所述阻挡件可随所述牵引丝的移动与与其近端侧相邻的所述固定件相抵并在两者的抵接处形成新的牵拉点。
在其中一个实施例中,在所述m>n时,n个所述阻挡件分别与m个所述固定件中的n个一一对应,使得每一所述阻挡件的近端侧均有一与其相邻的所述固定件,每一所述阻挡件与位于其近端侧相邻的所述固定件之间均存在一个预设间距,从而形成n个预设间距,n个所述预设间距的尺寸相等或不等。
在其中一个实施例中,在所述m=n时,n个所述阻挡件与m个所述固定件一一匹配,使得每一所述阻挡件的近端侧均有一与其相邻的所述固定件,每一所述阻挡件与位于其近端侧相邻的所述固定件之间均存在一个预设间距,从而形成n个预设间距,n个所述预设间距的尺寸相等或不等。
在其中一个实施例中,n个所述预设间距自远至近逐渐增大,使得在牵拉所述牵引丝的过程中,n个所述阻挡件可随所述牵引丝的移动与与其近端侧相邻的所述固定件依次相抵并在抵接处依次形成n个新的牵拉点。
在其中一个实施例中,所述阻挡件呈球状、和/或柱状、和/或椭圆球状、和/或锥状。
在其中一个实施例中,所述阻挡件与所述固定件相抵时为弹性抵接。
在其中一个实施例中,所述阻挡件的近端侧和/或与所述阻挡件相邻的所述固定件的远端侧设有可轴向压缩的弹性部。
在其中一个实施例中,所述固定件为可套设于所述可调弯段上并近端侧与所述可调弯段相对固定的螺旋弹簧,所述螺旋弹簧的内径大于所述可调弯段的外径。
在其中一个实施例中,所述阻挡件可在所述牵引丝受到的拉力超过预设拉力时穿过所述固定件上的所述牵引通道。
在其中一个实施例中,所述固定件和所述阻挡件其中之一上设置有限位槽,可使得在抵接时其中另一个全部或者部分嵌入至所述限位槽中。
本发明还提供一种可控弯输送系统,包括具有预设轴向长度的可调弯构件、用于在拉力作用下牵拉所述可调弯构件弯曲的牵引丝以及用于控制所述可调弯构件弯曲程度的控弯组件;其中,所述可调弯构件包括位于远端的可调弯段;所述牵引丝的远端与所述可调弯段的远端相连,用于在外力作用下牵拉所述可调弯段弯曲;所述控弯组件包括套设于与所述可调弯段相对的所述牵引丝上的控弯套,所述控弯套设有p个,1≤p且p为自然数,p个所述控弯套的轴向长度之和不大于所述可调弯段的有效弯曲长度,p个所述控弯套用于在牵拉过程中调节所述可调弯段的弯曲程度。
在其中一个实施例中,所述控弯组件还包括固设于所述可调弯段上的固定件,所述固定件设有m个,1≤m且m为自然数,m个所述固定件沿所述可调弯段的轴向方向间隔设置,m个间隔设置的所述固定件将所述可调弯段分割成m+1个可调弯的子段;所述固定件上设有可供所述牵引丝穿过的牵引通道,所述牵引丝的远端穿过所述牵引通道与所述可调弯段的远端相连;其中,1≤p≤m+1,p个所述控弯套可选择性的与m+1个所述子段中的p个子段一一相对,每一所述控弯套的轴向长度均不大于与之相对的子段的有效弯曲长度。
在其中一个实施例中,所述控弯套活动的套设于所述牵引丝上,使得所述
控弯套可在所述牵引丝上相对所述控弯套轴向移动。
在其中一个实施例中,m+1个可调弯的所述子段自所述可调弯构件的远端至近端依次为第一子段、第二子段……第m+1子段;其中,m+1个可调弯的子段中,其中一子段用于与主动脉弓部相对,与主动脉弓部相对的所述子段具有最大的有效弯曲长度;p个所述控弯套中其中一所述控弯套套设于与该具有最大有效弯曲长度的所述子段相对的所述牵引丝上。
在其中一个实施例中,所述第二子段用于与主动脉弓部相对,所述第二子段具有最大的有效弯曲长度,其中一所述控弯套套设于与所述第二子段相对的所述牵引丝上。
在其中一个实施例中,所述第m+1子段具有最小的有效弯曲长度。
在其中一个实施例中,所述第m+1子段的有效弯曲长度不大于20mm。
在其中一个实施例中,p个所述控弯套包括不可发生轴向形变的刚性套和/或可发生轴向形变的弹性套。
在其中一个实施例中,p个所述控弯套中存在至少两个弹性套,两个所述弹性套的弹性劲度系数不同。
在其中一个实施例中,两个所述弹性套的弹性劲度系数自远至近依次增大。
在其中一个实施例中,一所述控弯套包括沿所述牵引丝的轴向方向依次设置的q个子套,1≤q且q为自然数,q个所述子套相连或不连,q个所述子套的轴向长度之和不大于与之相对的所述可调弯段的有效弯曲长度。
在其中一个实施例中,在所述控弯套包括可发生轴向形变的弹性套,且q个所述子套中存在至少两个子弹性套时,两个所述子弹性套的弹性劲度系数不同。
在其中一个实施例中,两个所述子弹性套的弹性劲度系数自远至近依次增大。
在其中一个实施例中,所述固定件包括螺旋弹簧,所述螺旋弹簧套设于所述可调弯段上并至少部分与所述可调弯段固定,所述可调弯段与所述螺旋弹簧之间设有可供所述牵引丝穿过的牵引通道。
本发明还提供一种可调弯输送系统,包括具有预设轴向长度的可调弯构件以及用于在拉力作用下牵拉所述可调弯构件弯曲的牵引丝;所述可调弯构件包括位于远端的可调弯段,所述可调弯段上设有多个牵拉点,所述牵拉点至少包括沿所述可调弯段的轴向方向间隔设置的r个轴向牵拉点,2≤r且r为自然数;
所述牵引丝设有s根,2≤s且s为自然数;其中,r≤s,s根所述牵引丝中的r根的远端与r个所述轴向牵拉点分别连接,牵拉s根所述牵引丝以调节所述可调弯段的弯曲程度。
在其中一个实施例中,r个所述轴向牵拉点不均位于同一纵向直线上,使得r个所述轴向牵拉点在垂直于所述可调弯构件的轴向方向上的投影不完全重叠。
在其中一个实施例中,r个所述轴向牵拉点均位于所述可调弯构件的小弯侧。
在其中一个实施例中,在所述r<s且差值为a时,则所述可调弯段还包括与所述轴向牵拉点位于同一圆周上的周向牵拉点,所述周向牵拉点设有a个,a个所述周向牵拉点均位于同一圆周上或不均位于同一圆周上,a根所述牵引丝的远端与a个所述周向连接点分别连接。
在其中一个实施例中,a个所述周向牵拉点均位于所述可调弯构件的小弯侧。
在其中一个实施例中,所述可调弯输送系统还包括固设于所述可调弯段上的固定件,所述固定件设有m个,1≤m且m为自然数,m个所述固定件沿所述可调弯段的轴向方向间隔设置,所述固定件上设有可供所述牵引丝穿过的牵引通道。
在其中一个实施例中,所述可调弯输送系统还包括阻挡件,所述阻挡件设有n个,其中,1≤n≤s且n为自然数,n个所述阻挡件可选择性的固设于s个所述牵引丝上,且n个所述阻挡件沿轴向方向间隔排布;其中,一个所述阻挡件间隔位于一个所述固定件的远端侧并同时位于一个所述牵拉点的近端侧,使得所述阻挡件可随所述牵引丝的移动与与其近端侧相邻的所述固定件相抵并在两者的抵接处形成新的牵拉点。
在其中一个实施例中,所述可调弯构件还包括连接于所述可调弯段的近端侧的支撑段,所述可调弯输送系统还包括套设于所述支撑段外的推杆,所述推杆的管壁上轴向上设有可供所述牵引丝穿过的第二限位通道,所述第二限位通道设有t个,t个所述第二限位通道相互平行,其中,1≤t≤s且t为自然数。
在其中一个实施例中,t个所述第二限位通道均位于所述可调弯构件的小弯侧。
在其中一个实施例中,所述可调弯输送系统还包括套设于与所述可调弯段相对的所述牵引丝外的控弯套,所述控弯套设有p个,1≤p且p为自然数,p个所述控弯套的轴向长度之和不大于所述可调弯段的有效弯曲长度,p个所述控弯套用于在牵拉过程中进一步调节所述可调弯段的弯曲程度。
本发明的输送系统通过调节输送系统前端的弯曲角度,既可以使支架顺利到达弯曲部位,也能使支架在释放时前端可位于主动脉弓部中间,降低“鸟嘴”效应。另外,限位件及阻挡件800的设置不仅避免了牵拉件的缠绕,同时对调弯的方向以及调弯段进行控制,实现了逐级分段精准的控弯。进一步的,控弯套与多根牵引丝的设置可以使得调弯方式更加灵活,提升了输送系统的调弯性能,确保介入器械可被精准的输送并释放至预设位置。
图1为本发明示例性的输送系统的结构示意图一;
图2为本发明示例性的输送系统的结构示意图二;
图3为本发明示例性的输送系统的局部结构示意图三;
图4为本发明示例性的外鞘管与手柄内的固定底座的连接示意图;
图5为本发明示例性的推杆与外鞘管的结构示意图;
图6为本发明示例性的牵引丝与手柄的一种连接示意图;
图7为本发明示例性的牵引丝与手柄的另一种连接示意图;
图8(a)为本发明示例性的具有半释放结构的支架的一种结构示意图;
图8(b)为本发明示例性的具有半释放结构的支架的另一种结构的释放后的示意图;
图8(c)为本发明示示例性的具有半释放结构的支架的另一种结构的释放前的示意图;
图9为本发明示例性的内鞘芯组件的结构示意图;
图10为本发明示例性的牵引丝与内鞘芯组件的倒钩的一种连接示意图;
图11为本发明示例性的牵引丝与内鞘芯组件的倒钩的另一种连接示意图;
图12为本发明示例性的外鞘芯组件的结构示意图;
图13为本发明示例性的外鞘芯组件的锚定件的结构示意图;
图14为本发明示例性的牵引丝穿过锚定件的支架固定杆之间的间隙与倒钩连接的示意图;
图15为本发明未设置固定件的输送系统在血管内弯曲时的形态示意图;
图16为本发明示例性的输送系统设有固定件时的一种结构示意图;
图17为本发明示例性的输送系统设有固定件时的另一种结构示意图;
图18为本发明示例性的固定件的结构示意图;
图19为本发明示例性的输送系统设有多个固定件时的一种结构示意图;
图20为本发明示例性的输送系统设有多个固定件时的另一种结构示意图;
图21为本发明示例性的输送系统设有多个固定件时的又一种结构示意图;
图22为本发明设置固定件的输送系统在血管内弯曲时的形态示意图;
图23为本发明示例性的牵引丝上设有阻挡件时的结构示意图;
图24为本发明设置固定件和阻挡件配合时的输送系统在血管内弯曲时的形态示意图;
图25为本发明示例性的固定件上设置限位槽的半剖示意图;
图26为本发明示例性的阻挡件与固定件弹性抵接的一种实施示意图;
图27为本发明示例性的阻挡件与固定件弹性抵接并可穿过固定件的一示意图;
图28为本发明示例性的阻挡件与固定件弹性抵接并可穿过固定件的另一示意图;
图29为本发明示例性的输送系统中设置控弯套的结构示意图;
图30为本发明示例性的控弯套为刚性套的调弯示意图一;
图31为本发明示例性的控弯套为刚性套的调弯示意图二;
图32为本发明示例性的设有控弯套的输送系统在人体血管中的其中一种应用场景示意图;
图33为本发明示例性的设有控弯套的输送系统中同一区域内设有多个子套的示意图;
图34为本发明示例性的输送系统中设有多个牵拉点的结构示意图;
图35和图36分别为牵拉本发明示例性的设有多个牵拉点的输送系统中的牵引丝时,可调弯段的弯曲状态一和弯曲状态二;
图37为本发明示例性的设有多个牵拉点的输送系统中的多根牵引丝的一种连接方式;
图38~图40分别为牵拉本发明示例性的设有多个牵拉点的输送系统中的不同牵引丝时输送系统的弯曲形态;
图41分别为本发明示例性的设有多个牵拉点的输送系统的推杆的截面示意图;
图42为α=180°时本发明示例性的设有多个牵拉点的输送系统的弯曲形态;
图43为α=90°时本发明示例性的设有多个牵拉点的输送系统的弯曲形态。
为了使本发明的目的、技术方案及优点更加清楚明白,下面将参照附图更详细地描述本公开的示例性实施方式。虽然附图中显示了本公开的示例性实施方式,然而应当理解,可以以各种形式实现本公开而不应被这里阐述的实施方式所限制。相反,提供这些实施方式是为了能够更透彻地理解本公开,并且能够将本公开的范围完整的传达给本领域的技术人员。
应理解的是,文中使用的术语仅出于描述特定示例实施方式的目的,而无意于进行限制。除非上下文另外明确地指出,否则如文中使用的单数形式“一”、“一个”以及“所述”也可以表示包括复数形式。术语“包括”、“包含”、“含有”以及“具有”是包含性的,并且因此指明所陈述的特征、步骤、操作、元件和/或部件的存在,但并不排除存在或者添加一个或多个其它特征、步骤、操作、元件、部件、和/或它们的组合。文中描述的方法步骤、过程、以及操作不解释为必须要求它们以所描述或说明的特定顺序执行,除非明确指出执行顺序。还应当理解,可以使用另外或者替代的步骤。
尽管可以在文中使用术语第一、第二、第三等来描述多个元件、部件、区域、层和/或部段,但是,这些元件、部件、区域、层和/或部段不应被这些术语所限制。这些术语可以仅用来将一个元件、部件、区域、层或部段与另一区域、层或部段区分开。除非上下文明确地指出,否则诸如“第一”、“第二”之类的术语以及其它数字术语在文中使用时并不暗示顺序或者次序。因此,以下讨论的第一元件、部件、区域、层或部段在不脱离示例实施方式的教导的情况下可以被称作第二元件、部件、区域、层或部段。
为了便于描述,可以在文中使用空间相对关系术语来描述如图中示出的一个元件或者特征相对于另一元件或者特征的关系,这些相对关系术语例如为“内部”、“外部”、“内侧”、“外侧”、“下面”、“下方”、“上面”、“上方”等。这种空间相对关系术语意于包括除图中描绘的方位之外的在使用或者操作中装置的不同方位。例如,如果在图中的装置翻转,那么描述为“在其它元件或者特征下面”或者“在其它元件或者特征下方”的元件将随后定向为“在其它元件或者特征上面”或者“在其它元件或者特征上方”。因此,示例术语“在……下方”可以包括在上和在下的方位。装置可以另外定向(旋转90度或者在其它方向)并且文中使用的空间相对关系描述符相应地进行解释。
另外,需要说明的是,在本发明中将植入人体或动物体内的医疗器械或者
输送该医疗器械的输送器的距离操作者较近的一端定义为“近端”,将距离操作者较远的一端定义为“远端”,并依据此原理定义医疗器械或者输送器的任一部件的“近端”和“远端”。“轴向”指医疗器械在被输送时的长度方向,“径向”指医疗器械的与其“轴向”垂直的方向,并依据此原理定义医疗器械的任一部件的“轴向”和“径向”。
总体的,本发明旨在提供一种输送系统,以将装载其内的介入器械输送至预设位置。所述输送系统至少包括具有预设轴向长度的可调弯构件以及用于在拉力作用下牵拉所述可调弯构件弯曲的牵引丝。所述可调弯构件包括位于远端的可调弯段,牵引丝与可调弯段相连,牵拉牵引丝可至少使可调弯段相对可调弯构件的纵向中心轴弯曲。其中,介入器械包括但不限于支架、封堵器、介入人工心脏瓣膜等,以下实施例将以支架为例对本发明的输送系统进行示例性说明,应当理解,并不局限于此。需说明的是,以下所有的实施例均基于本总体的输送系统展开,以下实施例将单独或组合的方式结合至总体的输送系统中,以寻求更优的调弯方案及效果解决现有技术存在的介入器械无法精准放置的问题。
实施例一
基于上述总体的输送系统,本实施例的输送系统在总体的输送系统的基础上,进一步限定所述可调弯构件为鞘芯组件。即本实施例的输送系统包括鞘芯组件及牵引丝。鞘芯组件用于与介入器械可拆卸连接并将与之可拆卸连接的介入器械输送至预设位置,牵引丝用于在外力作用下牵拉鞘芯组件弯曲。在采用本实施例的输送系统输送介入器械的过程中,与鞘芯组件可拆卸连接的介入器械可在整个过程(包括输送及半释放过程)中随鞘芯组件的弯曲而弯曲,使得介入器械可被精准的送达并释放到预设位置。
参照图1~图3所示,具体的,本实施例的输送系统包括鞘芯组件100及牵引丝200。鞘芯组件100包括位于远端的可调弯段100a,其中,可调弯段100a的长度及划分界限可根据需要进行设置,并不做具体限定。牵引丝200的远端与可调弯段100a相连,牵拉牵引丝200可至少使可调弯段100a相对鞘芯组件100的纵向中心轴x弯曲。由于鞘芯组件100为具有预设轴向长度的构件,必然的,鞘芯组件100具有一纵向中心轴x,牵引丝200偏置的位于鞘芯组件100的
一侧,且牵引丝200的远端与鞘芯组件100的位于远端的可调弯段100a相连,牵拉牵引丝200使可调弯段100a相对鞘芯组件100的纵向中心轴x偏向弯曲。需说明的是,牵引丝200的远端与可调弯段100a相连可为固定连接或可拆卸式连接。
本实施例的输送系统可在牵拉牵引丝的过程中使鞘芯组件的可调弯段100a弯曲,在输送系统输送介入器械(例如支架)的过程中,即使外鞘管后撤支架处于半释放状态,但鞘芯组件依然可以在牵引丝的牵拉过程中携带与之可拆卸连接的介入器械进行弯曲,依然可调整输送系统的远端,改变输送系统远端的弯曲角度,使支架能顺利且精准的到达弯曲部位,使支架在释放时远端能够位于主动脉弓部中间,从而避免内漏降低“鸟嘴”效应,解决支架的远端在小弯侧无法紧密贴壁的问题。
参照图2和图3,进一步的,本实施例的输送系统还包括中空的外鞘管300,外鞘管300套设在鞘芯组件100外侧,且鞘芯组件100的远端更靠近输送系统的远端,即鞘芯组件100的远端相对外鞘管300的远端伸出,外鞘管300的内壁与鞘芯组件100的外壁之间存在第一间隙w1,外鞘管300可相对鞘芯组件100轴向移动。其中,中空的外鞘管300为可调弯外鞘管或非可调弯外鞘管,外鞘管300的可调弯性可根据实际需要进行选择,在此并不做限定。优选的,外鞘管300为可调弯外鞘管,可调弯的外鞘管可进一步增强输送系统的可调弯性,以进一步确保介入器械能顺利到达弯曲部位。较佳的,可对外鞘管的远端进行预弯,预弯后的外鞘管,更容易弯曲,通过调节近端侧的调弯手柄,使装载有介入器械的输送系统的远端呈微弯曲状,从而更容易通过弯曲的血管。需说明的是,可调弯的外鞘管300的具体结构及调节方式可参照现有技术,在此不做赘述。
示例性的,作为外鞘管300相对鞘芯组件100轴向移动的一种实施方式,结合图2~图4,外鞘管300的管体为空心管,外鞘管300另一端连接固定底座M,手柄500内置凹槽结构(未示出)连接固定底座M,通过后撤手柄500拉动外鞘管300,使外鞘管300相对鞘芯组件100向后移动,将装载区域301a内的支架释放出来,解除外鞘管300对支架的径向约束。
参照图3和图5,基于本实施例上述任一输送系统的结构,进一步的,本实施例的输送系统还包括套设于鞘芯组件100上的推杆400。在所述输送系统装载有支架600时,套设于鞘芯组件100上的推杆400的远端端面与支架600的近
端端面相对。在输送系统包括外鞘管300时,推杆400位于鞘芯组件100和外鞘管300之间的第一间隙w1内,且推杆400的内壁与鞘芯组件100的外壁之间存在第二间隙w2。
如图5所示,示例性的,推杆400的主体为空心管,用较硬的高分子材料制成,推杆400的近端通过输送系统的限位结构(未示出)与输送系统的手柄相对固定而不可轴向移动。优选的,空心管的管壁上设有小通道孔401。优选的,小通道孔401设置多个,多个小通道孔401可沿空心管的管壁周向间隔设置。
继续参照图2,基于本实施例上述任一输送系统的结构,进一步的,本实施例的输送系统还包括手柄500,鞘芯组件100的近端和牵引丝200的近端均伸入手柄500内与手柄500连接,通过手柄500牵拉牵引丝200的近端至少使鞘芯组件100的远端相对其轴线弯曲。需说明的是,除输送系统的鞘芯组件100的近端和牵引丝200的近端均伸入手柄500内与手柄500连接外,当输送系统还包括外鞘管300和/或推杆400时,外鞘管300和/或推杆400的近端也均伸入手柄500内与输送手柄连接,通过手柄500对外鞘管300进行轴向移动操作以及对推杆400进行固定。其中,当外鞘管300为可调弯鞘管时,也可通过手柄500对外鞘管300同时进行调弯及轴向移动操作。
其中,鞘芯组件100、外鞘管300及推杆400与手柄500的连接方式及操作方式可参照现有技术,在此并不做赘述。以下将对牵引丝200与手柄500的连接方式做示例性说明,应当说明,其连接方式并不局限于此。
参照图6所示,作为一种实施方式,手柄500内轴向上设有多个凹槽卡扣501,形成多个档位,可设置每个挡位对应一个弯曲角度。限位件N1与手柄500卡扣连接,同时限位件N1与牵引丝200的近端相连,通过选择挡位移动限位件N1可拉动牵引丝200,使牵引丝200受力。在牵引丝200受力的状态下,鞘芯组件100远端受到弯曲力,达到不同弯曲角度的效果。
参照图7所示,作为另外的实施方式,手柄500内部设置螺纹结构,限位件N2与手柄500螺纹连接,同时限位件N2与牵引丝200的近端相连,通过旋转的方式牵拉牵引丝200,使牵引丝200受力。在牵引丝200受力的状态下,鞘芯组件100远端受到弯曲力,达到不同弯曲角度的效果。需说明的是,上述方式仅为示例性说明,牵引丝200与手柄500的连接方式并不局限于此。
继续参照图3,基于本实施例上述任一输送系统的结构,进一步的,本实施例的输送系统还预装载有一介入器械。示例性的,介入器械为支架600,支架
600的远端与鞘芯组件100的远端可拆卸连接,使得在支架600未脱离鞘芯组件100之前,支架600均可随鞘芯组件100的弯曲而发生偏转,从而对支架600的位置进行调整。其中,在输送系统设有外鞘管300时,支架600被径向压缩收容于外鞘管300与鞘芯组件100之间的第一间隙w1内,收容于第一间隙w1内的支架600的远端与鞘芯组件100的远端可拆卸连接。在支架600被输送至预设位置后外鞘管300向近端移动后撤,从而使得支架600脱离外鞘管300对其带来的径向约束。
参考图8(a)所示,示例性的,支架600包括具有超弹性的直筒状金属骨架610及外层的聚合物薄膜620,其中远端有部分金属骨架无聚合物薄膜包裹,即形成裸支架610a,裸支架610a勾挂于鞘芯组件100的远端,从而实现支架600的远端与鞘芯组件100的远端可拆卸连接。应当说明的是,支架600结构并不局限于此。
优选的,所述支架600为具有半释放结构的支架。作为一种实施方式,继续参照图8(a)所示,半释放结构包括线扣630及释放件640。线扣630为高分子材料做成,设于金属骨架610上。优选地,线扣630固定于金属骨架610的波峰上。示例性的,释放件640为一可活动的金属杆或金属丝,位于支架600其中一侧。所有的线扣630套在释放件640上,以达到径向压缩支架600的目的。通过牵拉释放件640,即金属杆或金属丝,使金属杆或金属丝后撤,与支架600上的线扣分离,支架600径向上不再受束缚,径向上可完全展开。释放件640另一端穿过推杆400的小通道孔401后固定于输送装置尾端手柄500上,尾端手柄内置凹槽结构连接金属杆或金属丝,达到牵拉金属杆或金属丝的效果。作为另外的实施方式,参照图8(b),与上述具有半释放结构的支架结构不同的是,半释放结构进一步还包括约束件650,示例性的,约束件650为双层高分子材料线。支架600上部分线扣630之间采用双层高分子材料线固定。优选地,选择支架600其中一面采用双层高分子材料线固定,并且线扣630处于金属骨架140的波峰和波谷中间。参照图8(c),在制作过程中,双层高分子材料线的两端分别穿过其余线扣630并固定于释放件640上,即固定于可活动的金属杆或金属丝上,使支架600径向上受高分子材料线650压缩处于半束缚状态。应当说明的是,支架的半释放结构并不局限于此。其中,释放件640可根据需要设置一个或多个,当牵引丝200穿过推杆400的小通道孔时,为了避免金属杆或金属丝与牵引丝造成干涉影响,可将释放件640的金属杆或金属丝与牵引丝
分别穿过推杆400上的不同的小通道孔401。当释放件640设置两个时,优选地,释放件640设置在支架的两侧,并分别通过推杆400两侧的小通道孔401,此时,可将牵引丝设置在支架小弯侧部分。这一设置不仅避免了由于金属杆或金属丝设置在小弯侧而引起的干涉问题。同时避免了由于金属杆或金属丝设置在大弯侧而引起的路径较长、阻力较大、不利于其释放的问题,因此金属杆或金属丝设置在支架的两侧为最优。
基于本实施例上述任一输送系统的结构,下述将对鞘芯组件100及牵引丝200的结构及连接关系进行示例性说明,下述的结构及连接方式均可与上述任一的输送系统的结构进行组合,只要在不影响支架正常释放的基础上能够实现通过牵拉牵引丝200使鞘芯组件100远端弯曲即可。
结合图1、图9及图12所示,鞘芯组件100包括内鞘芯组件101和/或外鞘芯组件102。即存在鞘芯组件100包括内鞘芯组件101;或鞘芯组件100包括外鞘芯组件102;或鞘芯组件100同时包括内鞘芯组件101和外鞘芯组件102的多种情况。牵引丝200的远端与内鞘芯组件101的远端和/或外鞘芯组件102的远端相连。即存在牵引丝200的远端仅与内鞘芯组件101的远端相连;或牵引丝200的远端仅与外鞘芯组件102的远端相连;或牵引丝200的远端与内鞘芯组件101的远端和外鞘芯组件102的远端同时相连的多种情况。应当知晓,牵引丝200至少与内鞘芯组件101、外鞘芯组件102其中之一相连。本实施例仅对鞘芯组件100同时包括内鞘芯组件101和外鞘芯组件102的情况进行示例性说明。可理解的是,在鞘芯组件100仅包括内鞘芯组件101或者外鞘芯组件102时,其内鞘芯组件101和外鞘芯组件102的结构以及与牵引丝200的连接方式均可参照下述的实施方式。
如图1所示,示例性的,本实施例的鞘芯组件100同时包括内鞘芯组件101和外鞘芯组件102,内鞘芯组件101和外鞘芯组件102至少部分套设,其中,外鞘芯组件102在外,内鞘芯组件101在内,内鞘芯组件101的远端更靠近输送系统的远端,且外鞘芯组件102可相对内鞘芯组件101轴向移动,牵引丝200的远端与内鞘芯组件101的远端和/或外鞘芯组件102的远端相连。应当说明的是,本实施例的牵引丝200的远端与内鞘芯组件101的远端和/或外鞘芯组件102的远端相连可为直接相连,也可为通过其他部件间接相连。
参照图9所示,内鞘芯组件101包括内鞘芯管101a、固设于内鞘芯管101a远端的引导头101b及设于引导头101b近端的倒钩101c。其中,内鞘芯组件101
内轴向上设有一可供导丝穿过的导丝腔(未示出)。内鞘芯管101a、引导头101b及倒钩101c三者可通过粘接、注塑、焊接等方式连接为一体,内鞘芯管101a的近端与手柄500的内部固定,且内鞘芯管101a不可相对手柄500轴向移动。当牵引丝200的远端与内鞘芯组件101的远端相连时,牵引丝200可与内鞘芯管101a、引导头101b及倒钩101c中的其中一个或者任一两个或者与三个均相连。连接方式不限于焊接、粘接或其他方式直接或间接固定。当牵引丝200与远端的引导头101b连接时,调弯可直接作用于引导头101b上,使引导头101b产生弯曲。当牵引丝200与倒钩101c连接时,由于远端倒钩101c通常采用金属类强度较高的材料制成,因此,牵引丝200与倒钩101c的连接力更强,远端连接的位置可承受的拉力更大。优选的,引导头101b具有一定的柔软度,可顺应血管弯曲,也可制作成预弯状态。倒钩101c优选为圆角倒钩。圆角倒钩101c和外鞘芯组件102的锚定件102b配合可使介入器械可拆卸的与鞘芯组件100相连,支架600远端上的裸支架610a可勾挂于锚定件102b上,通过拉动外鞘芯组件102后撤,倒钩101c对支架进行阻挡,可使先前勾挂于锚定件102b上的支架600与外鞘芯组件100分离。结合图9和图10所示,倒钩101c包括连接于引导头101b近端的连接部101c1及连接于连接部101c1近端的限位部101c2,限位部101c2径向凸出连接部101c1。优选的,限位部101c2的凸出部分的外周面上凹设有用于可供锚定件102b穿过的凹陷部,相邻的凹陷部之间形成用于阻挡的凸起部。
如图10所示,当牵引丝200的远端与倒钩101c相连时,作为连接的一种实施方式,限位部101c2的凸出连接部101c1的凸起部上轴向上设有通孔101c21,牵引丝200穿过通孔101c21与倒钩101c相连。例如,牵引丝200穿过通孔101c21后勾挂于连接部101c1上,或者牵引丝200穿过通孔101c21后在牵引丝200的末端再形成直径大于通孔101c21的阻挡件,从而实现连接。通孔101c21设于凸起部上,不仅可实现连接,还可避免对裸支架的释放造成影响。作为连接的另一种实施方式,如图11所示,凹陷部内设有一滑轮结构101d,牵引丝200通过一金属环勾挂于连接部101c1上后通过滑轮结构101d,该结构可以使得在提供牵引力的时候,改变力的方向,使原本沿输送系统轴向的牵引力转化为对圆角倒钩的径向拉力,可以极大地减少所需提供的牵引力,也使得牵引丝200在受力时的张力减小,从而减小对支架切割的风险。
参照图12所示,示例性的,外鞘芯组件102包括套设于内鞘芯管101a外
的外鞘芯管102a及设于外鞘芯管102a远端的锚定件102b,牵引丝200可与外鞘芯管102a及锚定件102b中的其中一个或者两个均相连。连接方式包括但不限于焊接、粘接或其他方式直接或间接固定。当牵引丝200与外鞘芯组件102的远端连接时,相同的弯曲角度下,需要提供的调弯力更小。
继续参照图12,外鞘芯管102a为中空结构,中间通道可插入内鞘芯管101a,外鞘芯管102a包括柔性空心管102a1和刚性空心管102a2。锚定件102b为金属件。锚定件102b、柔性空心管102a1和刚性空心管102a2三者可通过粘接、注塑焊接等方式连接为一体,刚性空心管102a2的近端与手柄500的内部连接,并预留可往后拉动外鞘芯管102a的空间。示例性的,参照图12和图13所示,锚定件102b包括与外鞘芯管102a的远端相连的锚接体102b1及设于锚接体102b1远端的支架固定杆102b2,支架固定杆102b2沿锚接体102b1的周向间隔设置多个,相连的支架固定杆102b2之间存在可容置裸支架的间隙。
当鞘芯组件100包括内鞘芯管101a、引导头101b、倒钩101c、外鞘芯管102a及锚定件102b时,牵引丝200可与其中任一一个连接,当然,为了提高连接的可靠性,也可与其中的多个连接,多个指两个及两个以上。一般的,在装载过程中,由于外鞘芯管102a未后撤时,外鞘芯管102a是完全包围在内鞘芯管101a外侧,此时可不将牵引丝200与内鞘芯管101a连接,而选择与其他连接。优选的,选择将牵引丝200与倒钩101c和/或引导头101b连接,原因在于,一方面施加的作用力可直接作用于更靠近远端的外鞘芯组件上,能够快速实现调整。另一方面,即使在支架脱离了锚定件102b或处于半脱离状,依然可以直接牵拉内鞘芯组件进行微调。需注意的是,若选择将牵引丝200与外鞘芯组件102和内鞘芯组件101连接时,由于外鞘芯组件102需要进行后撤,为了避免对外鞘芯组件102造成影响,牵引丝200可选择穿过外鞘芯组件102的方式与内鞘芯组件101连接。其中,连接方式包括但不不限于焊接、粘接或其他方式直接或间接固定。
如图14所示,较佳的,牵引丝200的远端穿过锚定件102b的支架固定杆102b2之间的间隙仅与倒钩101c连接,这样不仅可以在支架完成半释放过程中对鞘芯组件的远端进行调弯,且裸支架由于勾挂在支架固定杆102b2上,并不会对支架600的释放造成任何影响。当然,牵引丝200的远端还可以再延长伸入引导头101b内与引导头101b连接。
下述将对牵引丝200的放置位置进行示例性说明,牵引丝200的放置位置
可根据输送系统的实际结构进行设置。例如,参照图3所示,当输送系统包括外鞘管300时,牵引丝可置于鞘芯组件100和外鞘管300之间的第一间隙w1内,牵引丝200置于第一间隙w1内后牵引丝200的远端与鞘芯组件100的远端相连,牵引丝200可在第一间隙w1内移动,牵引丝200的近端延伸与手柄500相连,通过手柄500对牵引丝200进行牵拉操作。
作为另外的实施方式,外鞘管300的管壁在轴向上设有第一限位通道(未示出),牵引丝200置于第一限位通道后牵引丝200的远端与鞘芯组件100的远端相连,牵引丝200可在第一限位通道内移动,牵引丝200的近端穿出第一限位通道与手柄500相连,通过手柄500对牵引丝200进行牵拉操作。
继续参照图3,例如,当输送系统包括推杆400时,牵引丝200可置于鞘芯组件100和推杆400之间的第二间隙w2内,牵引丝200置于第二间隙内后牵引丝200的远端与鞘芯组件100的远端相连,牵引丝200可在第二间隙内移动,牵引丝200的近端延伸与手柄500相连,通过手柄500对牵引丝200进行牵拉操作。
作为另外的实施方式,推杆400的管壁上轴向上设有第二限位通道,例如可为上述的小通道孔401,牵引丝200可置于第二限位通道后远端与鞘芯组件100的远端相连,牵引丝200可在第二限位通道内移动,牵引丝200的近端穿出第二限位通道与手柄500相连,通过手柄500对牵引丝200进行牵拉操作。这样牵引丝200有很长的一段是处于推杆400的小通道孔401内,而推杆400具有一定的硬度,可控制牵引丝200的路径,防止调弯过程中游离的牵引丝200路径发生改变进而导致弯曲角度发生改变。同时,防止了牵引丝200在调弯过程中丝缠绕于鞘芯组件上。其中,牵引丝200偏置设置,优选地,牵引丝200位于小弯一侧,可以控制输送系统的弯曲方向。较佳的,牵引丝200与释放件640进入的小通道孔401应分别处于不同侧。需要注意的是,为了避免对支架600的释放造成影响,在设有支架600的一段处,牵引丝200穿过支架600的内部。
本实施例的牵引丝的远端与鞘芯组件的远端相连,牵拉牵引丝的近端可至少使鞘芯组件的远端相对其轴线弯曲,通过调节输送系统前端的弯曲角度,既可以使支架顺利到达弯曲部位,也能使支架在释放时前端可位于主动脉弓部中间,降低“鸟嘴”效应。
实施例二
上述总体的输送系统或实施例一的输送系统虽然分别可对可调弯构件或者鞘芯组件实现调弯,但问题在于,会出现牵引丝200与鞘芯组件100缠绕,同时在牵拉过程中会出现如图15所示的情况,在牵拉过程中牵引丝200对支架或血管产生切割性的损伤。鉴于此,本实施例在上述总体的输送系统或实施例一的输送系统的基础上,进一步提出一种防缠绕及防切割的输送系统。
参照图1和图16,本实施例的输送系统在前述的基础上进一步包括固定件700。即本实施例的输送系统包括具有预设轴向长度的可调弯构件、用于在拉力作用下牵拉可调弯构件弯曲的牵引丝200以及固设于所述可调弯构件的可调弯段上的固定件700。其中,可调弯构件包括位于远端的可调弯段100a,牵引丝200的远端与可调弯段100a的远端相连,用于在外力作用下牵拉所述可调弯段100a弯曲。可调弯构件以及牵引丝的具体结构以及连接方式参见上述总体的输送系统或实施例一的输送系统,在此不再赘述。优选的,为了保证调弯效果,本实施例的可调弯构件可选如实施例一所述的鞘芯组件100,鞘芯组件100的结构可参照上述实施例一。应当知晓的是,若仅是基于防缠绕及切割的目的,本实施例的可调弯构件并不限于为鞘芯组件100。
继续参照图16,本实施例的固定件700设有m个,1≤m且m为自然数,m个固定件700沿可调弯段100a的轴向方向间隔设置,固定件700的间隔距离可根据需要进行设置。如图17所示,固定件700上设有可供牵引丝200穿过的牵引通道710,牵引丝200可相对固定件700轴向移动,牵引丝200穿过牵引通道710后与可调弯构件的可调弯段100a相连并在相连处形成初始牵拉点。本实施例的牵引丝200从固定件700的牵引通道710中穿过,不仅防止了牵引丝200缠绕,同时可对可调弯构件的弯曲路径进行限位,避免在牵拉过程对支架或血管产生切割性的损伤。
如图16所示,示例性的,固定件700可单侧固设于可调弯构件的可调弯段100a的外壁上,当牵引丝200同时穿过固定件700的牵引通道710及推杆400上的小通道孔401时,固定件700上的牵引通道710与推杆400上的小通道孔401相对。还可的是,如图18所示,柱状的固定件700a围绕鞘芯组件100一周设置,柱状的固定件700a固定套设于可调弯段100a的外侧。
固定件700的形状及轴向上的长度可根据需要进行设置,例如,如图19所示,可设置具有较长轴向长度的杆状的固定件700b。如图20所示,也可设置具有较短的轴向长度的柱状的固定件700a。还可为贴附于可调弯段100a外的薄膜
固定件,例如固定件700可通过高分子材料薄膜形成,高分子材料薄膜通过热缩、或粘接等方式固定在可调弯段100a外,并在薄膜与可调弯段100a的外壁中间设计可共牵引丝200通过的牵引通道710。
其中,参照图20,m个固定件沿可调弯段100a的轴向方向间隔设置,m个间隔设置的固定件自可调弯构件的远端至近端依次为第一固定件、第二固定件……第m固定件,m个间隔设置的固定件将可调弯段100a分割成m+1个可调弯的子段,m+1个可调弯的子段自可调弯构件的远端至近端依次为第一子段、第二子段……第m+1子段。每一子段具有一有效弯曲长度。本发明所述的有效弯曲长度包括第一固定件与可调弯段100a的远端末端之间的距离(即图20中的D1)、第m固定件与可调弯段100a的近端末端之间的距离(即图20中的Dm+1)以及相邻的两个固定件之间的距离(即图中D1与Dm+1之间的每一子段的有效弯曲长度)。如图20所示,第一子段的有效弯曲长度为D1,第二子段的有效弯曲长度为D2,第三子段的有效弯曲长度为D3,第四子段的有效弯曲长度为D4依次类推,第m+1子段的有效弯曲长度为Dm+1。其中,各子段的有效弯曲长度可根据实际需要通过调节固定件之间的间隔距离来设置。示例性的,如图19所示,D1>D2,D3>D2。或如图20所示,D1>D2,D2=D3=D4=……=Dm+1。或如图21所示,m+1个可调弯的子段的有效弯曲长度自近端至远端逐渐增大,即D1>D2>D3>……>Dm+1。。
优选的,m+1个可调弯的子段中,其中一子段用于与主动脉弓部相对,与主动脉弓部相对的子段具有最大的有效弯曲长度。较佳的,第一子段或第二子段用于与主动脉弓部相对,第一子段或第二子段具有最大的有效弯曲长度。最大的有效弯曲长度的选择范围为42mm~66mm,其他子段的有效弯曲长度范围为31mm~56mm。第m+1子段具有最小的有效弯曲长度,优选的第m+1子段的有效弯曲长度不大于20mm,此时第m+1子段的弯曲角度极小。
对比图15和图22,图15和图22分别为未设置固定件的输送系统和设有固定件的输送系统在血管内弯曲时的形态。图22中第一子段用于与主动脉弓部相对,具有最大的有效弯曲长度,即D1最大,因此,第一子段的弯曲最明显,其余子段弯曲的程度比第一子段小,第m+1子段仅是因为顺应血管而弯曲,输送系统几乎不提供弯曲力。
本实施例通过固定件对牵引丝进行限位防止了牵引丝缠绕并避免了在牵拉过程对牵引丝支架或血管产生切割性的损伤。同时在可调弯构件为鞘芯组件时,
可调节输送系统前端的弯曲角度,可以使支架顺利到达弯曲部位,也能使支架在释放时前端可位于主动脉弓部中间,降低“鸟嘴”效应,使得介入器械进一步被精准放置。
实施例三(阻挡件)
上述实施例二的输送系统通过固定件700的限位防止了牵引丝200缠绕,同时避免了在牵拉过程对支架或血管产生切割性的损伤。但问题在于,如图22所示,牵引丝200在对可调弯构件的远端进行牵拉过程中,如果牵拉力度控制不好,容易造成牵拉过渡,导致可调弯构件远端末端刺穿血管壁,这样风险性高,且对牵拉的控制要求较高。鉴于此,本实施例在实施例二的基础上,进一步提出一种可对可调弯构件的可调弯段进行分段控弯的方案。
参照图23所示,本实施例提出一种可分段调弯输送系统,本实施例的输送系统在实施例二的基础上进一步包括阻挡件800。即本实施例的输送系统包括具有预设轴向长度的可调弯构件、用于在拉力作用下牵拉所述可调弯构件弯曲的牵引丝200、固设于所述可调弯构件的可调弯段100a上的固定件700以及固设于牵引丝上的阻挡件800。固定件700与阻挡件800共同构成用于实现可调弯构件100分段弯曲的控弯组件。可调弯构件包括位于远端的可调弯段100a,牵引丝200的远端与可调弯段100a的远端相连,用于在外力作用下牵拉所述可调弯段100a弯曲。其中,可调弯构件以及牵引丝200的具体结构以及连接方式参见上述总体的输送系统或实施例一或实施例二,在此不再赘述。优选的,为了保证调弯效果,本实施例的可调弯构件可选如实施例一所述的鞘芯组件100,鞘芯组件100的结构可参照上述实施例一。应当知晓的是,若仅是基于分段控弯的目的,本实施例的可调弯构件并不限于为鞘芯组件100。
如图23所示,固定件700固设于可调弯段100a上,阻挡件800固设于牵引丝200上,固定件700上设有可供牵引丝穿过的牵引通道710,牵引丝穿过牵引通道710且其远端与可调弯段100a的远端相连并在相连处形成初始牵拉点,阻挡件800与位于其近端侧相邻的固定件700之间设有预设间距;在牵拉牵引丝200的过程中,阻挡件800可随牵引丝200的移动缩小预设间距直至与固定件700相抵并在两者的抵接处形成新的牵拉点。当阻挡件800与固定件700接触时,即使拉力增加(指未达到预设最大拉力),也不会继续弯曲,有利于控制可调弯构件的最大弯曲程度。
参照图23和图24所示,牵引丝200上设有阻挡件800,在未牵拉牵引丝200的自然状态下,阻挡件800距离固定件700预设距离,在牵拉过程中,阻挡件800可与固定件700相抵,使得固定件700对阻挡件800进行轴向限位,形成新的牵拉点,避免对鞘管组件100远端进行过渡牵拉,防止可调弯构件远端因为过渡弯曲而末端刺穿血管壁。
如图23所示,固定件700设有m个,1≤m且m为自然数,m个固定件700沿可调弯段100a的轴向方向间隔设置。其中,m个固定件700的设置方式参见上述实施例二,在此不再赘述。继续参照图23,本实施例的阻挡件800设有n个,1≤n且n为自然数,n个阻挡件800沿牵引丝200的轴向方向间隔设置;n个阻挡件800可选择性的间隔位于m个固定件700的远端侧,使得阻挡件800可随牵引丝200的移动与与其近端侧相邻的固定件700相抵并在两者的抵接处形成新的牵拉点。
在m>n时,即固定件700的数量多于阻挡件800的数量,n个阻挡件800分别与m个固定件700中的n个一一对应,使得每一阻挡件800的近端侧均有一与其相邻的固定件700,每一阻挡件800与位于其近端侧相邻的固定件700之间均存在一个预设间距,从而形成n个预设间距,n个预设间距的尺寸相等或不等。在m=n时,即固定件700的数量与阻挡件800的数量相等时,n个阻挡件800与m个固定件700一一匹配,使得每一阻挡件800的近端侧均有一与其相邻的固定件700,每一阻挡件800与位于其近端侧相邻的固定件700之间均存在一个预设间距,从而形成n个预设间距,n个预设间距的尺寸相等或不等。本实施例中的固定件700不仅防止了牵引丝200缠绕,避免在牵拉过程对支架或血管产生切割性的损伤;同时可用于与阻挡件800配合实现可调弯构件的分段弯曲。
如图23所示,n个预设间距自远至近依次为L1、L2……Ln,n个预设间距自远至近逐渐增大,即L1<L2<……<Ln,使得在牵拉牵引丝200的过程中,n个阻挡件800可随牵引丝200的移动与与其近端侧相邻的固定件700依次相抵并在抵接处依次形成n个新的牵拉点。本实施例中,多个阻挡件800依次与其近端侧最近的一个固定件700之间的间距逐渐增大,这样使得在牵拉过程中,可以依次轴向上形成多个牵拉点,不仅避免了对鞘管组件100远端进行过渡牵拉了,且实现了对鞘芯组件100轴向上的逐级分段控弯。在该设计下,当拉动牵引丝时,D1区域受力最先发生弯曲,当弯曲的程度达到最大值时,阻挡件800
与固定件700接触。此时即使继续施加拉力(指未达到预设最大拉力),D1区域不会发生弯曲,但D2区域发生弯曲,后续的各段同理,该设计下实现了逐级分段调弯的效果。
示例性的,阻挡件800的形状包括但不限于呈球状、和/或柱状、和/或椭圆球状、和/或锥状等,只需控制阻挡件800与固定件700可相抵即可。更优选的,固定件700和阻挡件800其中之一上设置有限位槽,可使得在抵接时其中另一个全部或者部分嵌入至限位槽中。例如,如图25所示,固定件700上设有一限位槽720,限位槽720与牵引通道710贯通,在抵接时阻挡件800可嵌入限位槽中,使得连接的稳定性更好。
在优选实施例中,为了更好的掌控调弯力度以及实现更优的调弯效果,阻挡件800与固定件700相抵时为弹性抵接。弹性抵接的结构可以随着挤压需要使用的力越大,操作者能感知某一段是否已经快到弯曲极限,可以更好的去控制,不会导致一下子施加拉力导致刺破血管。当弹性抵接没有空间时,随着拉力增大,可能下一个抵接点形成牵拉点。另外弹性抵接使得调弯可以回弹,能更好的去控制弯曲角度。
作为弹性抵接的一种实施方式,阻挡件800的近端侧和/或固定件700的远端侧设有可轴向压缩的弹性部。示例性的,该弹性部为弹簧、扭簧或者柔性橡胶件等。如图26所示,固定件为可套设于可调弯段100a上并近端侧与可调弯段100a相对固定的螺旋弹簧700c,螺旋弹簧700c的内径大于可调弯段100a的外径,使得可以保证固定件700可套设于可调弯段100a上。该设计不仅实现了弹性抵接,且可使螺旋弹簧的厚度可设计得较薄,降低了可调弯构件上整体的外径,使得介入器械在输送系统内具有更多的空间。
为了进一步提升分段弯曲的灵活性,在弹性抵接时,可使阻挡件800在牵引丝700受到的拉力超过预设拉力时穿过固定件700上的牵引通道710。阻挡件800被牵拉时固定件700和阻挡件800接触位置形成挤压力,当该力超过预设拉力时时,阻挡件800从固定件700上的牵引通道710上通过,继续牵拉牵引丝200可以使位于该固定件700远端的可调弯段继续弯曲,即可以通过控制牵拉力的大小,从而控制阻挡件800从固定件700穿过或者不穿过,在不穿过时控制前一段的弯曲,在穿过后可继续控制,并增大了可控的长度。优选的,可进一步设置某个阻挡件仅穿过其中的一个或者两个固定件,而在于不能穿过的固定件抵接时,依然能形成固定的牵拉点。
一实施例中,在阻挡件800与固定件700相抵时为弹性抵接,且阻挡件800在牵引丝700受到的拉力超过预设拉力时穿过固定件700上的牵引通道710时,参考图27,固定件700的牵引通道710内设有弹簧701和活动件702,活动件702可随弹簧701升高或者降低,当阻挡件800被拉至牵引通道710内时,随着拉力的增加,弹簧701被压缩,当牵拉力足够大时,弹簧701被压缩至足够阻挡件800通过时,阻挡件800即可从固定件700的牵引通道710穿过,从而与下一固定件700再抵接形成新的牵拉点。在另一实施例中,参考图28,固定件700的牵引通道710内设有具有坡面的橡胶件703,由于橡胶件703具有弹性,当拉力足够大,将橡胶件703压缩至足够阻挡件800通过时,阻挡件800即可通过,从而形成新的牵拉点。
本实施例通过在可调弯段上设置固定件700并在牵引丝200上设置阻挡件800实现了分段控弯,从而使牵引丝200的各个位置弯曲到位,还能避免牵引丝200的远端弯曲过大的情况。进一步,当本实施例的阻挡件800和固定件700弹性抵接,当牵拉牵引丝200的力足够大时,可以使阻挡件800穿过固定件700上的牵引通道710,将阻挡件800牵拉到与其相应的固定件700的近端侧,从而使与其相应的可调弯段在牵引丝200的作用下能够继续弯曲,另外,弹性抵接的结构可以随着挤压需要使用的力越大,操作者能感知某一段是否已经快到弯曲极限,可以更好的去控制,不会导致一下子施加拉力导致刺破血管。
实施例四(控弯套)
上述实施例三的输送系统实现了分段控弯,但其分段控弯是通过固定件700与阻挡件800抵接形成限位的方式,其问题在于,在输送系统制作完成后,分段控弯的先后顺序只能自远至近依次进行且调弯方式固定,无法根据实际需求更灵活的对各段进行调弯。鉴于此,本实施例在上述总体的输送系统或实施例一的输送系统或实施例二的输送系统的基础上,进一步提出一种可对可调弯构件的可调弯段100a灵活控弯的方案。
参照图29,本实施例提出一种可控弯输送系统,可控弯输送系统包括具有预设轴向长度的可调弯构件、用于在拉力作用下牵拉可调弯构件弯曲的牵引丝200以及用于控制可调弯构件弯曲程度的控弯组件。可调弯构件包括位于远端的可调弯段100a;牵引丝200的远端与可调弯段100a的远端相连,用于在外力作用下牵拉可调弯段100a弯曲。其中,可调弯构件以及牵引丝200的具体结构以
及连接方式参见上述总体的输送系统或实施例一或实施例二,在此不再赘述。优选的,为了保证调弯效果,本实施例的可调弯构件可选如实施例一所述的鞘芯组件100,鞘芯组件100的结构可参照上述实施例一。应当知晓的是,若仅是基于灵活控弯的目的,本实施例的可调弯构件并不限于为鞘芯组件100。
参照图29,本实施例的控弯组件包括套设于与可调弯段100a相对的牵引丝200上的控弯套900,控弯套900活动的套设于牵引丝200上,使得控弯套900可在牵引丝200上相对控弯套900轴向移动。其中,控弯套900设有p个,1≤p且p为自然数,p个控弯套900的轴向长度之和不大于可调弯段100a的有效弯曲长度,p个控弯套900用于在牵拉过程中调节可调弯段100a的弯曲程度。其中,此处的所述有效弯曲长度指可调弯段100a内的可弯曲的有效长度。例如,如果在可调弯段100a上设置其他不可调弯部件,则需要除去该部分的长度。
优选的,控弯套900可为不可弯曲的刚性套或者可弯曲的弹性套。即p个控弯套900包括不可发生轴向形变的刚性套和/或可发生轴向形变的弹性套。应当知晓,当存在多个控弯套900时,多个控弯套900可部分为刚性套,另一部分为弹性套。多个指两个及两个以上。优选的,若p个控弯套900中存在至少两个弹性套,则两个弹性套的弹性劲度系数相同或不同。在两个弹性套的弹性劲度系数不同时,两个弹性套的弹性劲度系数自远至近依次增大。
进一步的,为了实现分段有效的控弯,本实施例的控弯组件还包括固设于可调弯段100a上的固定件700,固定件700设有m个,1≤m且m为自然数,m个固定件700沿可调弯段100a的轴向方向间隔设置,m个间隔设置的固定件700将可调弯段100a分割成m+1个可调弯的子段;固定件700上设有可供牵引丝200穿过的牵引通道,牵引丝200的远端穿过牵引通道与可调弯段100a的远端相连;其中,1≤p≤m+1,p个控弯套900可选择性的与m+1个子段中的p个子段一一相对,每一控弯套900的轴向长度均不大于与之相对的子段的有效弯曲长度。其中,本实施例的固定件700的设置方式可参见实施例二,在此不再赘述。可理解,在本实施例包括固定件700时,此处所述的有效弯曲长度包括第一固定件与可调弯段100a的远端末端之间的距离、第m固定件与可调弯段100a的近端末端之间的距离以及相邻的两个固定件之间的距离。
m+1个可调弯的子段自可调弯构件的远端至近端依次为第一子段、第二子段……第m+1子段;其中,m+1个可调弯的子段中,其中一子段用于与主动脉弓部相对。优选的,与主动脉弓部相对的子段具有最大的有效弯曲长度;p个控
弯套900中其中一控弯套900套设于与该具有最大有效弯曲长度的子段相对的牵引丝200上。较佳的,第二子段用于与主动脉弓部相对,第二子段具有最大的有效弯曲长度,其中一控弯套900套设于与第二子段相对的牵引丝200上。第m+1子段具有最小的有效弯曲长度。第m+1子段的有效弯曲长度不大于20mm。
进一步,固定件700包括螺旋弹簧,螺旋弹簧套设于可调弯段100a上并至少部分与可调弯段100a固定,可调弯段100a与螺旋弹簧之间设有可供牵引丝200穿过的牵引通道。螺旋弹簧的内径大于可调弯段100a的外径,使得可以保证固定件700可套设于可调弯段100a上。该设计不仅实现了弹性抵接,且可使螺旋弹簧的厚度可设计得较薄,降低了可调弯构件上整体的外径,使得介入器械在输送系统内具有更多的空间。
示例性的,如图30,控弯套包括刚性套900a,刚性套可用金属制成,如不锈钢。牵引丝200穿过该刚性套,与刚性套间可发生相互位移。该刚性套长度为L,满足L≤D2,其中,D2为第二子段的有效弯曲长度。可以理解,L的长度决定D2区域可弯曲的最大程度,L越短,D2区域的可弯曲程度越大。如图30,在该设计下,当提供一牵拉力时,D2区域的有效弯曲长度最大,因此D2区域优先弯曲,其余区域刚开始未发生明显弯曲,当继续增大牵拉力时,其余区域也随之发生弯曲。如图31所示,由于D2区域最大的弯曲程度受L限制,在持续增大牵拉力的过程中,D2区域达到最大弯曲程度后不继续弯曲,其余区域仍然可继续发生弯曲,实现灵活的分段调弯效果。
图32为该输送系统在人体血管中的其中一种应用场景示意图,D2区域位于主动脉弓的部位,D1区域位于升主动脉部位。可通过先调节D2区域的弯曲程度,使勾挂于鞘芯组件上的支架与小弯侧靠近,当D2区域达到设计的弯曲程度后,进一步调节可使D1区域发生弯曲,进一步调节支架的近端和血管的贴壁性。其中,D1、D2….Dm+1区域可根据实际的需求进行设计,刚性通道300也可根据实际需求选择性地设计在各个区域上。
示例性的,如图30,控弯套900包括弹性套,弹性套设计为弹簧结构(非刚性结构),且弹簧长度L≤D2,优选的L=D2。设弹簧套的最大压缩量为ΔL,则当弹簧长度为L-ΔL时,对应D2区域的最大弯曲角度。该设计下,输送系统不仅可实现灵活的分段控弯;且采用弹簧套设计可在整段区域内覆盖牵引丝,有效地避免裸露的牵引丝对人体血管造成的伤害。另外,弹簧具有恢复性,在压缩后可恢复原本的形状。因此,当撤掉牵拉力后,D2区域可以恢复为原本的
形状,有利于输送系统的回撤。
在其他实施例中,一控弯套900包括沿牵引丝200的轴向方向依次设置的q个子套,1≤q且q为自然数,q个子套相连或不连,q个子套的轴向长度之和不大于与之相对的可调弯段100a的有效弯曲长度。
其中,子套可为不可发生轴向形变的子刚性套和/或可发生轴向形变的子弹性套。在子套可为不可发生轴向形变的子刚性套时,同一区域内所有子套的长度之和为该区域的最大弯曲角度下对应的曲线弦长。在控弯套900包括可发生轴向形变的弹性套,且q个子套中存在至少两个子弹性套时,两个子弹性套的弹性劲度系数相同或不同。优选的,在两个子弹性套的弹性劲度系数不同时,两个子弹性套的弹性劲度系数自远至近依次增大。
示例性的,如图33所示,同一区域内有三段子弹性套(也可以是多段),以下各段分别用901、902、903表示。各段子弹性套的劲度系数分别以K1、K2、K3表示,K1、K2、K3三者并不是完全相等的关系,优选的,K1<K2<K3。因此,子弹性套901受力最容易变形,而子弹性套903受力最难以变形,使得在D2区域内的弯曲曲线的曲率是逐渐降低的。同理,可根据不同的血管形态,选择不同的子弹性套长度及劲度系数,参考该方式在同一区域内设置出符合血管形态的弯曲曲线。
优选的,可将具有不同劲度系数的各子弹性套连续设置,即各子弹性套连续后形成一个弹性套,该弹性套的不用段具有不同的劲度系数,在该实施例下,即使不设计固定件700,仅通过在牵引丝上套弹性套亦可实现分段调弯的功能。
进一步,在其他实施例中,控弯组件还包括固设于牵引丝200上的阻挡件800,阻挡件800的结构及设置方式可参照上述实施例二,通过阻挡件800与固定件700抵接、以及控弯套等多种方式实现分段控弯,提高了控弯的灵活性以及精准度。
实施例五(多个牵引丝200)
为了进一步提高控弯的灵活性,参照图34,本实施例提供一种可调弯输送系统,包括具有预设轴向长度的可调弯构件以及用于在拉力作用下牵拉可调弯构件弯曲的牵引丝200;可调弯构件包括位于远端的可调弯段100a,可调弯段100a上设有多个牵拉点110,牵拉点110至少包括沿可调弯段100a的轴向方向间隔设置的r个轴向牵拉点110a,2≤r且r为自然数;牵引丝200设有s根,2
≤s且s为自然数;其中,r≤s,s根牵引丝200中的r根的远端与r个轴向牵拉点分别连接,牵拉s根牵引丝200以调节可调弯段100a的弯曲程度。优选的,为了保证调弯效果,本实施例的可调弯构件可选如实施例一所述的鞘芯组件100,鞘芯组件100的结构可参照上述实施例一。应当知晓的是,若仅是基于灵活控弯的目的,本实施例的可调弯构件并不限于为鞘芯组件100。
优选的,轴向方向间隔设置的r个轴向牵拉点110a不均位于同一纵向直线上,使得r个轴向牵拉点110a在垂直于可调弯构件的轴向方向上的投影不完全重叠。较佳的,为了很好的对小弯侧进行控制,r个轴向牵拉点110a均位于可调弯构件的小弯侧。
其中,牵引丝200的数量可以设置的大于r个轴向牵拉点110a的数量,在r<s且差值为a时,则可调弯段100a还包括与轴向牵拉点110a位于同一圆周上的周向牵拉点110b,周向牵拉点110b设有a个,a个周向牵拉点110b均位于同一圆周上或不均位于同一圆周上,a根牵引丝200的远端与a个周向牵拉点110b分别连接。优选的,a个周向牵拉点110b均位于可调弯构件的小弯侧。
继续参照图34所示,在其他实施例中,可调弯输送系统还包括固设于可调弯段100a上的固定件700,固定件700设有m个,1≤m且m为自然数,m个固定件700沿可调弯段100a的轴向方向间隔设置,固定件700上设有可供牵引丝200穿过的牵引通道。其中,固定件700的结构以及设置方式可参照实施例二,在此不再赘述。
继续参照图34所示,在其他实施例中,可调弯输送系统还包括阻挡件800,阻挡件800设有n个,其中,1≤n≤s且n为自然数,n个阻挡件800可选择性的固设于s个牵引丝200上,且n个阻挡件800沿轴向方向间隔排布;其中,一个阻挡件800间隔位于一个固定件700的远端侧并同时位于一个牵拉点110的近端侧,使得阻挡件800可随牵引丝200的移动与与其近端侧相邻的固定件700相抵并在两者的抵接处形成新的牵拉点110。其中,阻挡件800的结构以及与固定件700的配合方式可参照实施例三,在此不再赘述。
继续参照图34所示,可调弯构件还包括连接于可调弯段100a的近端侧的支撑段100b,可调弯输送系统还包括套设于支撑段100b外的推杆400,推杆400的管壁上轴向上设有可供牵引丝200穿过的第二限位通道,即图中的小通道孔401,第二限位通道设有t个,t个第二限位通道相互平行,其中,1≤t≤s且t为自然数。t个第二限位通道均位于可调弯构件的小弯侧。
可调弯输送系统还包括套设于与可调弯段100a相对的牵引丝200外的控弯套,控弯套设有p个,1≤p且p为自然数,p个控弯套的轴向长度之和不大于可调弯段100a的有效弯曲长度,p个控弯套用于在牵拉过程中进一步调节可调弯段100a的弯曲程度。其中,控弯套的结构以及设置方式可参照实施例四,在此不再赘述。
其中,如图18所示,固定件700上设有多个牵引通道710可允许牵引丝200通过。鞘芯组件100为软质高分子材料,牵引丝210和220分别在远端设有固定点,通过推杆400的小孔道孔401后在近端分别固定于不同的牵拉机构上。其中,推杆400可在小弯侧设多个小孔道孔401,每个小孔道孔401对应一根牵引丝200,也可在推杆400小弯侧的小孔道孔401内设多个独立通道,每个独立通道对应一根牵引丝200。
继续参照图34,可调弯段100a的区域为调弯区域,由于每根牵引丝200在远端都有一个固定点,均可使100a区域受力弯曲。如图34所示,D1、D2….Dm+1均为牵引丝200两个固定端之间的距离。当Dm+1≤20mm时,Dm+1段的弯曲角度极小。当牵拉牵引丝210时,如图35,可调弯段100a的区域整体发生弯曲;当牵拉220牵引丝时,如图36,可调弯段100a的除D1外的区域发生弯曲。当同时牵拉2根牵引丝时,两者重叠的弯曲区域可产生叠加效果,不重叠的弯曲区域不发生干涉。因此,可根据实际使用情况选择如何进行牵拉。另外2根牵引丝可固定于同一牵拉机构上,同时进行牵拉。2根牵引丝如图37所示,远端分别独立固定,通过固定件后通过焊接、粘接等工艺使2根牵引丝融为一体进入推杆的通道中,并在远端固定于牵拉机构上。
如图2所示,输送系统上设置的是多根牵引丝,每根牵引丝分别在远端固定,可实现每一段具有不同程度的弯曲效果。以3根牵引丝为例,图38为210、220和230三根牵引丝一起进行调弯时输送系统的弯曲形态。图39为220和230两根牵引丝一起进行调弯时输送系统的弯曲形态。图40为230进行调弯时输送系统的弯曲形态。
不同的是,牵引丝可分布在不同侧。如图41所示,其为推杆400的截面视图,同理,固定件700的截面视图与推杆一致,至少确保2根牵引丝的通道在同一水平线。210和220分别为2根牵引丝,2根牵引丝所处位置夹角为α,0°≤α≤180°。这样设计的作用是,当单根牵引丝受到牵拉时,输送系统会朝牵引丝设计的方向弯曲,当2根牵引丝同时受到牵拉时,弯曲角度可在空间上进
行叠加,达到立体调弯的效果。图42为α=180°时,输送系统的弯曲形态,图43为α=90°时,输送系统的弯曲形态。
输送系统上设置的是多根牵引丝,可根据实际需求,使可调弯段100a区域各段在空间上向不同方向的有不同程度的弯曲,更利于进入扭曲的血管中。优选的,牵引丝需要有一定的抗拉伸强度,若拉伸强度不足,牵引丝容易被拉长,导致行程损失,甚至被拉断,使功能丧失。可通过淬火工艺(加热到一定温度后急速冷却),提升金属的拉伸和断裂强度。
本发明的输送系统通过调节输送系统前端的弯曲角度,既可以使支架顺利到达弯曲部位,也能使支架在释放时前端可位于主动脉弓部中间,降低“鸟嘴”效应。另外,限位件及阻挡件的设置不仅避免了牵拉件的缠绕,同时对调弯的方向以及调弯段进行控制,实现了逐级分段精准的控弯。进一步的,控弯套与多根牵引丝的设置可以使得调弯方式更加灵活,提升了输送系统的调弯性能,确保介入器械可被精准的输送并释放至预设位置。
以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。
Claims (10)
- 一种可调弯输送系统,其特征在于,包括具有预设轴向长度的可调弯构件以及用于在拉力作用下牵拉所述可调弯构件弯曲的牵引丝;所述可调弯构件包括位于远端的可调弯段,所述可调弯段上设有多个牵拉点,所述牵拉点至少包括沿所述可调弯段的轴向方向间隔设置的r个轴向牵拉点,2≤r且r为自然数;所述牵引丝设有s根,2≤s且s为自然数;其中,r≤s,s根所述牵引丝中的r根的远端与r个所述轴向牵拉点分别连接,牵拉s根所述牵引丝以调节所述可调弯段的弯曲程度。
- 根据权利要求1所述的可调弯输送系统,其特征在于,r个所述轴向牵拉点不均位于同一纵向直线上,使得r个所述轴向牵拉点在垂直于所述可调弯构件的轴向方向上的投影不完全重叠。
- 根据权利要求1所述的可调弯输送系统,其特征在于,r个所述轴向牵拉点均位于所述可调弯构件的小弯侧。
- 根据权利要求1所述的可调弯输送系统,其特征在于,在所述r<s且差值为a时,则所述可调弯段还包括与所述轴向牵拉点位于同一圆周上的周向牵拉点,所述周向牵拉点设有a个,a个所述周向牵拉点均位于同一圆周上或不均位于同一圆周上,a根所述牵引丝的远端与a个所述周向连接点分别连接。
- 根据权利要求4所述的可调弯输送系统,其特征在于,a个所述周向牵拉点均位于所述可调弯构件的小弯侧。
- 根据权利要求1~5任一所述的可调弯输送系统,其特征在于,所述可调弯输送系统还包括固设于所述可调弯段上的固定件,所述固定件设有m个,1≤m且m为自然数,m个所述固定件沿所述可调弯段的轴向方向间隔设置,所述固定件上设有可供所述牵引丝穿过的牵引通道。
- 根据权利要求6所述的可调弯输送系统,其特征在于,所述可调弯输送系统还包括阻挡件,所述阻挡件设有n个,其中,1≤n≤s且n为自然数,n个所述阻挡件可选择性的固设于s个所述牵引丝上,且n个所述阻挡件沿轴向方向间隔排布;其中,一个所述阻挡件间隔位于一个所述固定件的远端侧并同时位于一个所述牵拉点的近端侧,使得所述阻挡件可随所述牵引丝的移动与与其近端侧相邻的所述固定件相抵并在两者的抵接处形成新的牵拉点。
- 根据权利要求1所述的可调弯输送系统,其特征在于,所述可调弯构件 还包括连接于所述可调弯段的近端侧的支撑段,所述可调弯输送系统还包括套设于所述支撑段外的推杆,所述推杆的管壁上轴向上设有可供所述牵引丝穿过的第二限位通道,所述第二限位通道设有t个,t个所述第二限位通道相互平行,其中,1≤t≤s且t为自然数。
- 根据权利要求1所述的可调弯输送系统,其特征在于,t个所述第二限位通道均位于所述可调弯构件的小弯侧。
- 根据权利要求1所述的可调弯输送系统,其特征在于,所述可调弯输送系统还包括套设于与所述可调弯段相对的所述牵引丝外的控弯套,所述控弯套设有p个,1≤p且p为自然数,p个所述控弯套的轴向长度之和不大于所述可调弯段的有效弯曲长度,p个所述控弯套用于在牵拉过程中进一步调节所述可调弯段的弯曲程度。
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CN103190967A (zh) * | 2013-03-15 | 2013-07-10 | 杭州启明医疗器械有限公司 | 一种介入器械输送系统及其鞘芯 |
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