CN114344677A - Guide wire, blood vessel intervention method thereof and blood vessel intervention device - Google Patents
Guide wire, blood vessel intervention method thereof and blood vessel intervention device Download PDFInfo
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- CN114344677A CN114344677A CN202111518563.6A CN202111518563A CN114344677A CN 114344677 A CN114344677 A CN 114344677A CN 202111518563 A CN202111518563 A CN 202111518563A CN 114344677 A CN114344677 A CN 114344677A
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Abstract
The application discloses a guide wire, a blood vessel intervention method and a blood vessel intervention device thereof, relates to the technical field of medical instruments, and aims to solve the problem of guide wire intervention blood vessel steering in the related technology. The guide wire comprises a guide wire main body which is tubular, one end of the guide wire main body is open, and the other end of the guide wire main body is closed, the hole axis of the tube hole of the guide wire main body is deviated from the central axis of the guide wire main body, so that the guide wire main body forms a thin tube wall area and a thick tube wall area; the blood vessel intervention device comprises a guide wire and a pressure regulating device, wherein the output end of the pressure regulating device is connected with the open end of a guide wire main body so as to regulate the pressure in a tube hole of the guide wire main body; the vascular intervention method comprises the following steps: when the closed end of the guide wire body reaches the branch blood vessel communicated with the blood vessel, the pressure in the tube hole is increased, so that the guide wire body deflects to enter the branch blood vessel, and the autonomous deflection of the guide wire at the branch blood vessel communicated with the blood vessel is realized.
Description
Technical Field
The application relates to the technical field of medical instruments, in particular to a guide wire, a blood vessel intervention method and a blood vessel intervention device.
Background
With the occurrence of cardiovascular and cerebrovascular diseases, vascular intervention operations such as vascular stents and the like are more and more common. The vascular intervention operation is a minimally invasive operation technology which reaches a far target area in a human body through a blood vessel by means of a guide wire and completes a corresponding medical process. It can effectively shorten the operation time, greatly relieve the pain of patients and shorten the recovery time, and has been widely applied at home and abroad. The guide wire can guide and control corresponding parts in various vascular interventional operations, and is a key instrument for the vascular interventional operations.
The guide wire structure in the related technology comprises a rigid section and a flexible section, wherein the flexible section can be molded into a required angle according to the bending condition of a blood vessel before entering the blood vessel, the blood vessel in a human body is complicated and complicated, the wall is thin and has multiple branches, and the guide wire can only selectively enter a specified blood vessel for operation, so that the situation that the guide wire is tried and replaced for multiple times inevitably exists in the blood vessel intervention operation process is caused, great difficulty is increased for delivery work, high requirements are undoubtedly put forward to medical care operating personnel, the operation time is prolonged, operation risks are increased due to the unavoidable shaking of hands and the fatigue of the last time operation, and the success rate and the safety of the operation are further influenced.
Disclosure of Invention
The embodiment of the application provides a guide wire, a blood vessel intervention method thereof and a blood vessel intervention device, which are used for solving the problem of steering of the guide wire in the intervention of blood vessels in the related art.
The embodiment of the application provides a seal wire, including the seal wire main part, the seal wire main part is the tubulose, and one end opening, and the other end is sealed, the hole axis of the tube hole of seal wire main part is deviated the axis setting of seal wire main part, so that the seal wire main part forms thin pipe wall district and thick pipe wall district, works as when pressure in the tube hole increases, the seal wire main part can to one side deflection at thin pipe wall district place.
In some embodiments, the guidewire body comprises a support section and a steering section connected; one end of the supporting section, which is far away from the steering section, is an open end of the guide wire body, and one end of the steering section, which is far away from the supporting section, is a closed end of the guide wire body; the supporting section is connected with a supporting piece used for limiting the deformation of the supporting section; a plurality of bulges are arranged in the tube hole of the turning section along the axial direction of the tube hole, and the bulges are positioned in the thin tube wall area.
In some embodiments, the support section comprises a rigid support section, and a flexible support section connected between the rigid support section and the turnaround section; the supporting piece comprises a flexible supporting piece and a rigid supporting piece, the flexible supporting piece penetrates through the flexible supporting section, the rigid supporting piece is used for limiting the deformation of the rigid supporting section, two ends of the flexible supporting piece are respectively connected with the rigid supporting piece and the steering section, and the flexible supporting piece can deflect along with the flexible supporting section.
In some embodiments, the hole axis of the turning section is offset from the hole axis of the flexible support section, so that the turning section and the flexible support section have different deflection directions when the pressure in the pipe hole is increased; or the bore axis of the turnaround section coincides with the bore axis of the flexible support section; wherein the bore axis of the flexible support segment coincides with a bore axis of the guidewire body.
In some embodiments, said bore axis of said turnaround section, said bore axis of said flexible support section are located on opposite sides of the XP' Z-plane, respectively; or the hole axis of the steering section and the hole axis of the flexible supporting section are respectively positioned on two opposite sides of a YP 'Z plane, wherein P' is any point on the central axis P.
In some embodiments, the bore axis of the turnaround section lies in the XP ' Z-plane and the bore axis of the flexible support section lies in the YP ' Z-plane, where P ' is any point on the central axis P.
In some embodiments, a plurality of the protrusions are equally spaced within the bore of the turning section.
In some embodiments, the rigid support is a support tube, and the support tube is inserted into the tube hole of the rigid support section or sleeved on the rigid support section.
In some embodiments, the flexible support is a spring having an increasing spring index in a direction axially of the support section and directed from the open end toward the closed end.
In some embodiments, the flexible supporting section and the turning section are both provided with developing elements, and the developing elements are positioned on one side of the flexible supporting section close to the opening end, one side of the turning section close to the closed end, and the connection part of the flexible supporting section and the turning section.
In some embodiments, the cross-sectional shape of the protrusion is any one of a triangle, a circular arc and a trapezoid.
In some embodiments, the outermost layer of the guidewire is coated with a hydrophilic coating.
In some embodiments, the angle θ at which the guidewire deflects ranges from 0 ° to 120 °.
In some embodiments, the guidewire has a diameter in the range of 0.4mm to 1 mm.
The embodiment of the application also provides a vascular intervention device, which comprises the guide wire and a pressure regulating device, wherein the output end of the pressure regulating device is connected with the open end of the guide wire main body so as to regulate the pressure in the tube hole of the guide wire main body.
In some embodiments, the pressure regulating device comprises: the output end of the pressure pump is connected with a connecting pipe, and the connecting pipe is connected with the opening end; the pressure gauge is connected to the output end of the pressure pump and used for detecting the pressure value in the pipe hole.
In some embodiments, the pressure pump is a balloon dilation pressure pump.
The embodiment of the present application further provides a vascular intervention method applied to any one of the guide wires in the above embodiments, including: when the closed end of the guide wire body reaches a branch blood vessel communicated with the blood vessel, the pressure in the tube hole is increased, so that the guide wire body deflects to enter the branch blood vessel.
The hole axis of the tube hole of the guide wire main body and the central axis of the guide wire are eccentrically arranged, so that the guide wire main body forms a thin tube wall area and a thick tube wall area, when the pressure in the tube hole is increased, the guide wire main body can deflect towards the thin tube wall area, therefore, the guide wire can deflect at a certain angle, and after entering a blood vessel, the guide wire can enter branch blood vessels at different angles to reach a target area. If the target area has a plurality of places, the target area is distributed on a plurality of branch vessels connected to different positions of the vessel, and the angle between each branch vessel and the vessel is less than or equal to the angle that the guide wire can deflect, therefore, the guide wire can reach the target areas of the vessels, the problem that the guide wire is inevitably tried and replaced for a plurality of times because the guide wire can only selectively enter the vessel with a fixed angle in the process of vessel intervention operation is solved, the universality of the guide wire is greatly improved, the difficulty of delivery work is reduced, in addition, the guide wire is not required to be replaced for a plurality of times, the operation time is shortened, and the success rate and the safety of the operation are further improved.
Drawings
In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present application, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.
FIG. 1 is a schematic structural view of a guidewire in some embodiments of the present application;
FIG. 2 is a schematic structural view of a turn section and a portion of a support section of the guidewire of FIG. 1;
FIG. 3 is a schematic structural view of a guidewire in some embodiments;
FIG. 4 is several cross-sectional views of a turn section of the guidewire of FIG. 1;
FIG. 5 is a perspective view and XOZ projection view of the corresponding guidewire in several cross-sections of the steering section of FIG. 4;
FIG. 6 is a tree diagram of blood vessels in some embodiments;
FIG. 7 is a schematic representation of four locations of one of the branch vessels b with the guidewire in communication with vessel a of FIG. 6 in some embodiments;
FIG. 8 is a schematic illustration of a guidewire in some embodiments from one of the positions in FIG. 6 where vessel a enters branch vessel b and then branch vessel c;
fig. 9 is a schematic structural diagram of a vascular access device in some embodiments.
Reference numerals:
100. a guidewire body; 101. a tube hole; 102. a thin tube wall region; 103. a thick pipe wall region; 104. a closed end; 105. an open end; 1. a turning section; 11. a protrusion; 2. a support section; 12. a support member; 3. a flexible support section; 31. a flexible support; 4. a rigid support section; 41. a rigid support;
20. a pressure pump; 21. a connecting pipe; 22. a pump chamber; 23. a pressure gauge;
p, a central axis of the guide wire body; q, a hole axis of the flexible support section; m, a hole axis of the pipe hole; n, the hole axis of the turning section.
Detailed Description
The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.
In the description of the present application, it is to be understood that the terms "center", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience in describing the present application and simplifying the description, but do not indicate or imply that the referred device or element must have a particular orientation, be constructed in a particular orientation, and be operated, and thus should not be construed as limiting the present application.
In the description of the present application, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; the specific meaning of the above terms in the present application can be understood in a specific case by those of ordinary skill in the art.
The terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present application, "a plurality" means two or more unless otherwise specified.
As shown in fig. 1 and 2, fig. 1 is a schematic structural view of a guide wire in some embodiments of the present application, and fig. 2 is a schematic structural view of a turning section and a partial support section of the guide wire in fig. 1. The embodiment of the application provides a guide wire, which comprises a guide wire body 100 which is tubular and has an opening at one end and a closed end at the other end, wherein a hole axis M of a tube hole 101 of the guide wire body 100 is deviated from a central axis P of the guide wire body 100, so that the guide wire body 100 forms a thin tube wall area 102 and a thick tube wall area 103, and when the pressure in the tube hole 101 is increased, the guide wire body 100 can deflect to the side where the thin tube wall area 102 is located.
Because the hole axis M of the tube hole 101 of the guide wire body 100 and the central axis P of the guide wire are eccentrically arranged, the guide wire body 100 forms a thin tube wall area 102 and a thick tube wall area 103, when the pressure in the tube hole 101 is increased, the guide wire body 100 can deflect towards the thin tube wall area 102, so that the guide wire can deflect at a certain angle, and after entering a blood vessel, the guide wire can enter branch blood vessels at different angles to reach a target area. If the target area has a plurality of places, the target area is distributed on a plurality of branch vessels connected to different positions of the vessel, and the angle between each branch vessel and the vessel is smaller than or equal to the deflection angle of the guide wire, thus, the guide wire can reach the target areas of the vessels, the problems that the guide wire can only selectively enter the vessel with a fixed angle and the guide wire is inevitably tried and replaced for a plurality of times in the process of vessel intervention operation are solved, the universality of the guide wire is greatly improved, the difficulty of delivery work is reduced, in addition, the guide wire is not required to be replaced for a plurality of times, the operation time is shortened, and the success rate and the safety of the operation are further improved.
In some embodiments, as shown in fig. 2, 6 and 7, fig. 6 is a tree-like vessel diagram in some embodiments, and fig. 7 is a schematic diagram of four locations of one of the branch vessels b where the guidewire communicates from the vessel a in fig. 6 in some embodiments. The guide wire body 100 comprises a support section 2 and a steering section 1 which are connected; one end of the support section 2, which is far away from the turning section 1, is an open end 105 of the guide wire body 100, and one end of the turning section 1, which is far away from the support section 2, is a closed end 104 of the guide wire body 100; the supporting section 2 is connected with a supporting piece 12 for limiting the deformation of the supporting section 2; the pipe hole 101 of the turning section 1 is internally provided with a plurality of protrusions 11 along the axial direction thereof, and the plurality of protrusions 11 are positioned in the thin pipe wall area 102.
Because the support 12 limits the deformation of the guide wire body 100, the delivery force and the support force of the guide wire are met, a plurality of bulges 11 are arranged in the pipe hole 101 of the steering section 1 along the axial direction thereof, the flexibility and the adjustment force of the guide wire are met, the flexibility of the guide wire is increased along the axial direction of the support section 2 and the direction from the open end 105 to the closed end 104, so that the flexibility, the delivery force, the support force and the adjustment force of the guide wire are greatly improved, when the pressure in the pipe hole 101 is increased, the steering section deflects firstly, when the guide wire enters a branch blood vessel b communicated with a blood vessel a, the steering section 1 deflects firstly to enter the branch blood vessel b, the guide wire is delivered forwards, and then the support section 2 enters the branch blood vessel b.
The closed end 104 is a solid circular arc, so that the guide wire can penetrate thrombus in the blood vessel when entering the blood vessel.
In some embodiments, as shown in fig. 2, the plurality of protrusions 11 are arranged in the tube hole 101 of the turning section 1 at equal intervals, and since the plurality of protrusions 11 are arranged in the thin tube wall area 102 at equal intervals, when the pressure in the tube hole 101 of the turning section 1 increases, the thin tube wall area 102 side of the tube hole 101 of the turning section 1 is uniformly stressed, so that the deflection angles of the whole turning section 1 are consistent, and the adjustment force of the guide wire is greatly improved.
Of course, besides the plurality of protrusions 11 being arranged at equal intervals, the protrusions 11 may be arranged at equal intervals as a whole, wherein the distance between two adjacent protrusions 11 is different from the equal interval, so that when the pressure in the pipe hole 101 of the turning section 1 increases, the pressure in the thin pipe wall area 102 of the pipe hole 101 at the non-equal interval section before the two protrusions 11 is different from the pressure in the equal interval section, and the turning section 1 is deflected between the two protrusions 11, thereby achieving the specified point deflection.
In some embodiments, as shown in FIG. 2, the protrusions 11 have a triangular shape, the width of the protrusions 11 can be in the range of 200 μm and 350 μm, the height of the protrusions 11 can be in the range of 90-140 μm, the minimum wall thickness of the thin tube wall region 102 is 25 μm, the maximum wall thickness of the thick tube wall region 103 is 75 μm, and the distance between two adjacent protrusions 11 can be in the range of 344 μm and 600 μm.
Specifically, the width of the projection 11 may be 200 μm, 210 μm, 220 μm, 230 μm, 240 μm, 250 μm, 260 μm, 270 μm, 280 μm, 290 μm, 300 μm, 310 μm, 320 μm, 330 μm, 340 μm, 350 μm, and it is understood that the width of the projection 11 is not limited to the above values, and may be any value within the above range.
Specifically, the height of the projections 11 may be 90 μm, 100 μm, 110 μm, 120 μm, 130 μm, 140 μm, 95 μm, 115 μm, 126 μm, 138 μm, and it is understood that the height of the projections 11 is not limited to the above value, and may be any value within the above range.
Specifically, the pitch between two adjacent protrusions 11 may be 344 μm, 350 μm, 360 μm, 370 μm, 400 μm, 420 μm, 450 μm, 500 μm, 555 μm, 570 μm, 578 μm, 580 μm, 600 μm, and it is understood that the pitch between two adjacent protrusions 11 is not limited to the above value, and may be any value within the above range.
Of course, the cross-sectional shape of the protrusion 11 may be any one of circular arc and trapezoid, in addition to the triangular shape.
It should be noted that the plurality of protrusions 11 are of uniform dimensions so that the thin wall regions 102 of the protrusions 11 of the diverter 1 are uniformly stressed when the pressure in the pipe bore 101 increases.
In some embodiments, as shown in fig. 1, 2, and 8, fig. 8 is a schematic view of a guidewire in some embodiments at one of the locations from vessel a in fig. 6 into branch vessel b and into branch vessel c. The supporting section 2 comprises a rigid supporting section 4 and a flexible supporting section 3 connected between the rigid supporting section 4 and the steering section 1, the supporting part 12 comprises a flexible supporting part 31 and a rigid supporting part 41, the flexible supporting part 31 is arranged on the flexible supporting section 3, the rigid supporting part 41 is arranged on the rigid supporting section 4, and two ends of the flexible supporting part 31 are respectively connected with the rigid supporting part 41 and the steering section 1, so that the pushing force and the supporting force of the guide wire are improved, and the guide wire is prevented from randomly rotating in a blood vessel; the flexible support part 31 can deflect along with the flexible support section 3, the flexible support part 31 enables the guide wire to improve the supporting force and the adjusting force of the guide wire, when the pressure in the pipe hole 101 is increased, the flexible support section 3 can also deflect, in this way, the deflection length of the guide wire can be increased, the application scene that the blood vessel a enters the branch blood vessel b or enters the branch blood vessel b from the blood vessel a and then enters the branch blood vessel c can be adapted, the flexible support part 31 also has certain supporting performance, when the pressure in the pipe hole 101 does not reach the value enabling the flexible support section 3 to deflect, the flexible support section 3 can not deflect, the application scene of the branch blood vessel far away from the blood vessel can be adapted, and the guide wire meets the requirements of the pushing force, the supporting force and the adjusting force of any application scene.
The length range of the steering section 1 is 8mm-20mm, the length range of the flexible supporting section 3 is 240mm-300mm, and the length of the rigid supporting section 4 is 1000mm-2000mm, so that when the guide wire enters a far branch blood vessel, the guide wire can deflect at the branch blood vessel, the support performance of the guide wire is ensured by the longer rigid supporting section 4, the guide wire is prevented from randomly rotating in the blood vessel, and the deflection precision of the guide wire steering section 1 is improved.
Specifically, as shown in fig. 1 and 5, the turnaround section 1 has a first length L1, the first length L1 being deflectable into a first curved shape having a first radius of curvature R1; the flexible support segment 3 has a second length L2, the second length L2 being deflectable into a second curved shape having a second radius of curvature R2. Specifically, the first length L1 is less than the second length L2, and the first radius of curvature R1 is less than the second radius of curvature R2.
Specifically, the first length L1 of the guide wire turn section 1 may be 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19mm, 20mm, and it is understood that the length of the guide wire turn section 1 is not limited to the above value, and may be any value within the above range.
Specifically, the second length L2 of the flexible support section 3 may be 240mm, 250mm, 260mm, 265mm, 270mm, 275mm, 280mm, 290mm, 300mm, and it is understood that the length of the flexible support section 3 is not limited to the above values, and may be any value within the above range.
Specifically, the length of the rigid support section 4 may be 1000mm, 1100mm, 1200mm, 1300mm, 1400mm, 1500mm, 1600mm, 1700mm, 1800mm, 1900mm, 2000mm, and it is understood that the length of the rigid support section 4 is not limited to the above value, and may be any value within the above range.
Of course, the support section 2 may include only the rigid support section 4 instead of only the flexible support section 3, and the support 12 is a rigid support 41 disposed on the rigid support section 4, and the guide wire may enter the application scenario of the branch vessel in the vicinity of the vessel, and meanwhile, the pushing force and the supporting force of the guide wire are not limited specifically herein.
In some embodiments, as shown in fig. 1, 2 and 6, the flexible support 31 is a spring, the spring index of which increases in the axial direction of the support section 2 and in the direction pointing from the open end 105 to the closed end 104. Thus, when the pressure in the pipe hole 101 is increased, the flexible supporting section 3 deflects from the side close to the closed end 104 to the open end 105 in sequence, and the deflection angle decreases progressively, so that the flexible supporting section 3 of the guide wire body 100 is smoothly transited with the turning section 1 and the rigid supporting section 4 well, and the application scene of the guide wire is further improved.
Note that, the spring index: also known as the spin ratio. D represents the spring pitch diameter, and D represents the spring wire diameter. The spring index C affects the strength, stiffness, stability and ease of manufacture of the spring. The C value is large, the diameter of the steel wire with the larger intermediate diameter D is smaller, the spring is softer, the rigidity is small, the deformation is easy, and the winding is easy. And if the C value is small, the spring is relatively hard and rigid and is not easy to wind.
Of course, the flexible support 31 may have a constant spring index, but may have an increasing spring index along the axial direction of the support section 2 and the direction from the open end 105 to the closed end 104, and is not limited herein.
The flexible support 31 may be a coil, as well as a spring.
In some embodiments, as shown in fig. 1 and fig. 2, the flexible supporting section 3 and the turning section 1 are provided with developing elements, and the developing elements are located on one side of the flexible supporting section 3 close to the open end 105, one side of the turning section 1 close to the closed end 104, and the connection between the flexible supporting section 3 and the turning section 1. Thus, when the guide wire enters the blood vessel, an operator can see the positions of the flexible supporting section 3 and the steering section 1 of the guide wire through the developing element, and further adjust the pressure value in the tube hole 101, so that the guide wire can be accurately deflected and enters the branch blood vessel with a certain angle.
The developing element can accurately position the depth of the guide wire entering the human body vessel, and simultaneously, the developing position is also a boundary position of different hardness of the guide wire.
It should be noted that the developing element may be a developing coil, or a developing coating may be applied to the outermost layer of the guide wire at a corresponding position.
Of course, the developing coil may be attached to both ends of the spring, or the developing coating may be applied to both ends of the spring.
The term "visualization" means that a black image is displayed when a hospital instrument performs radiography, and is mainly made of a material opaque to X-rays, and the visualization material may be gold, tungsten powder, platinum iridium, or the like.
The spring can be made of high-strength metal materials such as stainless steel and the like or alloy materials, the developing spring can be made of platinum or platinum alloy in a winding mode, or a layer of developing materials such as gold or tungsten powder is coated on the surface of the non-developing spring.
In some embodiments, as shown in fig. 1 and 3, fig. 3 is a schematic structural view of a guidewire in some embodiments. The rigid support part 41 is a support tube, and the support tube is arranged in the tube hole 101 of the rigid support section 4 in a penetrating manner, or the support tube is sleeved on the rigid support section 4, so that the situation of different diameters of the guide wire body 100 can be adapted on the basis of ensuring that the rigid support part 41 limits the deflection of the rigid support section 4, and the diameter of the guide wire is not too large or too small; in addition, when the rigid support part 41 is inserted into the pipe hole 101 of the guide wire body 100, the pipe hole 101 of the support section 2 is ensured to be communicated with the pipe hole 101 of the turning section 1, so that the rigid support part 41 does not block the pipe hole 101 of the rigid section of the guide wire body 100, the rigid support part 41 is ensured to limit the deflection of the rigid support section 4 of the guide wire body 100, and the turning section 1 of the guide wire body 100 can also realize turning.
When the supporting tube and the flexible supporting piece 31 are connected with each other in a connecting mode and are arranged on the outer wall of the guide wire body 100, the supporting tube and the flexible supporting piece 31 are coated with hydrophilic coatings, the steering section 1 can be coated with hydrophilic coatings, the lubricating property of the guide wire is improved, the friction between the guide wire and a blood vessel when the guide wire enters the blood vessel is reduced, and the passing performance of the guide wire in the blood vessel and the inner cavity of a related matched instrument is favorably improved. The mechanism is that the hydrophilic coating absorbs water molecules to form a gel-like film on the surface of the guide wire, the film can reduce the passing resistance of the guide wire in blood vessels and related matched instruments, so that the guide wire has good lubricity and tracking performance, the guide wire is easy to push, the passing capacity of the guide wire is effectively improved, the guide wire is easy to reach target positions in the blood vessels, and meanwhile, the formation of thrombus in the blood vessels can be effectively avoided.
In addition, the maximum outer diameters of the rigid support 41 and the flexible support 31 coated with the hydrophilic coating, that is, the maximum diameter of the guide wire is less than or equal to 1mm, so that the guide wire is not too thick to enter a thin blood vessel, and the application of the guide wire is limited.
When the support tube and the flexible support 31 are connected and arranged in the tube hole 101 of the guide wire body 100, the outer wall of the tube of the guide wire body 100 can be coated with a hydrophilic coating, so that the lubricity of the guide wire is improved, and the passing performance of the guide wire in a blood vessel and the inner cavity of a related matched instrument is improved.
In addition, the maximum diameter of the guide wire coated with the hydrophilic coating is larger than or equal to 0.4mm, so that the guide wire is prevented from being too thin, the requirement on the manufacturing process is higher, the manufacturing cost is high, and in addition, the guide wire is prevented from deflecting uncontrollably when entering a blood vessel due to overhigh integral flexibility.
Of course, the hydrophilic coating may be a single coating such as a PTFE coating or a silicone oil coating, or may be a combined coating obtained by combining the above coatings.
It should be noted that the connection of the support tube to the flexible support 31 may be an adhesive connection or a welded connection.
Support piece 12 and seal wire body 100 can form seal wire body 100 through adhesive connection, hot melt connection or through the polymer shaping on support piece 12 surface for seal wire body 100 and support piece 12 structure as an organic whole, like this, can effectively avoid the seal wire when getting into the blood vessel, and support piece 12 drops from seal wire body 100, and then causes the surgical accident.
Of course, the guide wire body 100 is formed on the surface of the support 12 by polymer molding, and an integral molding method such as extrusion molding or injection molding may be used.
In some embodiments, as shown in fig. 4 and 5, fig. 4 is several cross-sectional views of the turning section 1 of the guide wire in fig. 1, and fig. 5 is a spatial view and a XOZ projection view of the corresponding guide wire in several cross-sectional views of the turning section 1 in fig. 4. The hole axis N of the turning section 1 deviates from the hole axis Q of the flexible supporting section 3, so that the turning section 1 and the flexible supporting section 3 have different deflection directions when the pressure in the pipe hole 101 is increased. Thus, the directions of the thin tube wall regions 102 of the two segments, namely the turning segment 1 and the flexible support segment 3, of the guide wire body 100 are different, and further the turning segment 1 and the flexible support segment 3 of the guide wire are different in deflection directions, so that the guide wire can be deflected twice, the guide wire is in a C shape or an S shape, and the guide wire can enter a zigzag blood vessel, so that the guide wire can be used in more application scenes.
In fig. 1 and 4, a coordinate system referred to for describing the deflection direction of the guide wire is a first relative coordinate system, the length direction of the guide wire is a Z axis, the direction from the thin tube wall region 102 of the guide wire to the thick tube wall region 103 is a Y axis, the direction passing through the central axis P of the guide wire and perpendicular to the Y axis is an X axis, and P' is any point on the central axis P.
The coordinate system referenced in fig. 5 to describe the position of the guidewire in space is a second relative coordinate system that is in-line with the direction of the first relative coordinate, except that the origin of coordinates O is different from the first relative coordinate system and is not on the guidewire centerline axis P.
In some embodiments, as shown in fig. 4a, the hole axis N of the turning section 1 and the hole axis Q of the flexible supporting section 3 are respectively located on two opposite sides of the XP ' Z plane, and the hole axis N of the turning section 1 and the hole axis Q of the flexible supporting section 3 are both located on the YP ' Z plane, so that the guide wire turning section 1 and the flexible supporting section 3 are deflected on two opposite sides in the XP ' Z plane, and are S-shaped in the YOZ plane, and the projection view of the XOZ plane is a straight line, as shown in fig. 5 a.
Of course, the hole axis N of the turning section 1 and the hole axis Q of the flexible support section 3 may not be located in the YP 'Z plane, or may be located in the YP' Z plane, and they are not limited herein.
Of course, the hole axes N and Q of the turning section 1 and the flexible supporting section 3 may be located on two opposite sides of the XP' Z plane, respectively, and are not limited herein.
In some embodiments, as shown in fig. 4b, 4c, 7 and 8, the hole axis N of the steering section 1 is located on the XP ' Z plane, the hole axis Q of the flexible supporting section 3 is located on the YP ' Z plane, and the included angle formed by the angle NP ' Q is 90 °, so that twice deflections in two spatial planes can be realized by the thin tube wall regions 102 of the guide wire steering section 1 and the flexible supporting section 3 at a relative included angle of 90 °, that is, the flexible supporting section 3 deflects to the Y axis, the steering section 1 deflects to the X axis direction, and the projection views of the XOZ plane are respectively shown in fig. 5b and 5 c.
Of course, the angle NP' Q between the bore axis N of the guide wire turning section 1 and the bore axis Q of the flexible supporting section 3 may be any angle relative to each other, besides the relative included angle of 90 °, and is not limited specifically herein.
Of course, the hole axis N of the turning section 1 is located on the XP 'Z plane, the hole axis Q of the flexible support section 3 is located on a position other than the YP' Z plane, and the positions of the hole axis N of the turning section 1 and the hole axis Q of the flexible support section 3 may be interchanged, which is not particularly limited herein.
In some embodiments, as shown in fig. 4d, the hole axis N of the turning section 1 and the hole axis M of the flexible supporting section 3 are located on the YP' Z plane and are collinear and coincident, so that the deflection directions of the turning section 1 and the flexible supporting section 3 when the pressure in the tubular hole 101 increases are consistent, the guide wire turning section 1 and the flexible supporting section 3 deflect in a plane, which is C-shaped on the YOZ plane, and the projection view of the XOZ plane is a straight line, as shown in fig. 5 d.
Of course, the hole axes N of the turning section 1 and the hole axes Q of the flexible support section 3 may be located not only in the YP 'Z plane but also in the XP' Z plane, or may be located only in the XP 'Z plane or the YP' Z plane but not in a collinear manner, and are not particularly limited herein.
The material of the guide wire body 100 may be a silicone material, and may be a biocompatible polymer material such as a PEBAX (polyether block polyamide) resin material, a thermoplastic polyurethane elastomer rubber material, and the like.
The material of the supporting member 12 may be stainless steel or an alloy. The alloy material can be made of any one or more of nickel-titanium alloy, stainless steel, cobalt-based alloy, iron-manganese alloy, copper-zinc alloy and iron-nickel alloy.
In some embodiments, as shown in fig. 1 and 3, the angle θ of the guide wire deflection ranges from 0 ° to 120 °, which can be adapted to different application scenarios.
When the pressure in the tube hole 101 increases, the guide wire body 100 deflects to the side where the thin tube wall region 102 is located, and the deflection angle here refers to the deflection angle of the guide wire body 100 on the side where the thick tube wall region 103 is located.
As shown in fig. 7, the present embodiment also provides a vascular access method, when the closed end 104 of the guide wire body 100 reaches the branch vessel b connected to the blood vessel a, the pressure in the tubular hole 101 is increased to deflect the guide wire to enter the branch vessel b, so that the guide wire can be deflected at a certain angle, and the guide wire can enter the branch vessel b with different angles as shown in fig. 6 to reach the target region of the branch vessel b.
If the target area has a plurality of positions, the target area is distributed on a plurality of branch blood vessels b connected to different positions of the blood vessel a, and the angle between each branch blood vessel b and the blood vessel a is less than or equal to the angle that the guide wire can deflect, therefore, the guide wire can reach the target areas at the plurality of positions of the blood vessel a, the problem that the guide wire can only selectively enter the blood vessel with a fixed angle in the process of blood vessel intervention operation and the guide wire is inevitably tried and replaced for a plurality of times is solved, the universality of the guide wire is greatly improved, the difficulty of delivery work is reduced, in addition, the guide wire is not required to be replaced for a plurality of times, the operation time is shortened, and the success rate and the safety of the operation are improved.
It should be noted that the method is applied to any guide wire in the above embodiments, and the structure of the guide wire refers to the above embodiments, which are not described herein again.
The steps of the guidewire from the blood vessel a to the branch blood vessel b are as follows:
s1, delivering the closed end 104 of the guide wire into the blood vessel a, and continuously delivering the guide wire, wherein the closed end 104 reaches the branch blood vessel b communicated with the blood vessel a, as shown in fig. 7 a;
s2, increasing the pressure in the tube hole 101, the diverting section 2 is deflected towards the branch vessel b, as shown in fig. 7 b;
s3, the guidewire is continuously delivered until the flexible support section 3 is deflected into the branch vessel b, as shown in figure 7c,
s4, the pressure in the tubal ostium 101 is then slowly reduced and the turning section 2 straightens back and continues to deliver the guidewire until the target area, e.g., 7d, is reached.
It should be noted that the branch blood vessel b may be a blood vessel having only a straight line shape, the target region is on the branch blood vessel b, and the target region is reached according to the steps, and each branch blood vessel b may also communicate with one or more branch blood vessels having different deflection directions.
As shown in fig. 6 and 8, for example, a branch vessel b is connected with a branch vessel c with a different deflection direction, the vessel is in a zigzag shape, the target region is at the branch vessel c, and when a guide wire needs to pass from a vessel a through the branch vessel b into the branch vessel c, the above-mentioned S2 to S4 are repeated until the target region of the branch vessel c is reached.
It should be noted that the branch blood vessel c may be coplanar with the plane of the blood vessel a and the branch blood vessel b, or may not be coplanar with the plane of the blood vessel a and the branch blood vessel b, and is not limited herein.
The branch vessel c may be coplanar with the plane of the vessel a and the branch vessel b, and the structure of the guide wire is shown in fig. 4a, 4d, 5a and 5d with reference to the above embodiments, which will not be described herein again.
When the branch blood vessel c is not coplanar with the plane of the blood vessel a and the branch blood vessel b, the structure of the guide wire refers to the above embodiments, as shown in fig. 4b, fig. 4c, fig. 5b and fig. 5c, and will not be described again here.
Fig. 9 is a schematic structural diagram of a vascular access device in some embodiments, as shown in fig. 9. The embodiment of the application also provides a vascular intervention device, which comprises a guide wire and a pressure regulating device, wherein the output end of the pressure regulating device is connected with the open end 105 of the guide wire body 100, the guide wire can deflect at a certain angle by regulating the pressure value in the guide wire pipe hole 101, and after entering the blood vessel, the guide wire can enter the branch blood vessels with different angles as shown in fig. 6 and reach a target area.
It should be noted that, the structure of the guide wire refers to the above embodiments, and is not described herein again.
In some embodiments, as shown in fig. 9, the pressure regulating device 200 includes: pressure pump 20, manometer 23, the output of pressure pump 20 is connected with connecting pipe 21, and connecting pipe 21 is connected with the open end 105 of seal wire, and the pore 101 of pressure pump and seal wire is linked together, and manometer 23 connect in the output of pressure pump (20), like this, manometer 23 just can be used to detect the pressure value in pore 101, is convenient for to the detection of pressure value in the pore 101 of seal wire body 100, is convenient for to the accurate deflection of seal wire, improves the regulating force of seal wire.
In some embodiments, as shown in fig. 9, the pressure pump 20 is a balloon expansion pressure pump, and includes a pump cavity 22, a pressure gauge and a connecting pipe, the balloon expansion pressure pump has its own pressure gauge connected to the pump cavity 22 of the pressure pump, and the output end is connected to the connecting pipe, so that the connecting pipe 21 and the pressure gauge 23 connected to the pressure pump can be omitted, and since the output end of the pump cavity 22 is connected to the connecting pipe, the connecting pipe is connected to the open end 105 of the guide wire body 100, so that the pump cavity 22 of the pressure pump 20 is communicated with the tube hole 101 of the guide wire body 100, and thus the pressure in the tube hole 101 of the guide wire body 100 can be detected.
The connecting pipe of the balloon dilatation pressure pump is connected with a connector, the connector is a convex luer lock device of a luer connector, the guide wire opening end 105 is connected with a concave luer lock device of the luer connector, and the concave luer lock device and the guide wire body 100 are of an integral structure, so that the convenience and the reliability of connection of the pressure pump and the guide wire body opening end 105 are improved.
Of course, the connection between the female luer lock device with luer and the guidewire body 100 may be an integral structure, or may be fixed by gluing or the like.
It should be noted that a complete Luer fitting should include a male Luer-Lok connection fitting and a female Luer-Lok fitting.
In the description herein, particular features, structures, materials, or characteristics may be combined in any suitable manner in any one or more embodiments or examples.
The above description is only for the specific embodiments of the present application, but the scope of the present application is not limited thereto, and any person skilled in the art can easily conceive of the changes or substitutions within the technical scope of the present application, and shall be covered by the scope of the present application. Therefore, the protection scope of the present application shall be subject to the protection scope of the claims.
Claims (18)
1. A guidewire, comprising a guidewire body (100);
the guide wire body (100) is tubular, one end of the guide wire body is open, the other end of the guide wire body is closed, the hole axis (M) of the tube hole (101) of the guide wire body (100) deviates from the central axis (P) of the guide wire body (100) to enable the guide wire body (100) to form a thin tube wall area (102) and a thick tube wall area (103), and when the pressure in the tube hole (101) is increased, the guide wire body (100) can deflect towards one side (102) where the thin tube wall area (102) is located.
2. The guidewire of claim 1,
the guide wire body (100) comprises a supporting section (2) and a steering section (1) which are connected with each other;
one end, far away from the turning section (1), of the supporting section (2) is an open end (105) of the guide wire body (100), and one end, far away from the supporting section (2), of the turning section (1) is a closed end (104) of the guide wire body (100);
a support (12) used for limiting the deformation of the support section (2) is connected with the support section (2); a plurality of protrusions (11) are arranged in the pipe hole of the turning section (1) along the axial direction of the pipe hole, and the protrusions (11) are located in the thin pipe wall area (102).
3. The guidewire of claim 2,
the support section (2) comprises a rigid support section (4) and a flexible support section (3) connected between the rigid support section (4) and the turning section (1);
the supporting piece (12) comprises a flexible supporting piece (31) arranged in the flexible supporting section (3) in a penetrating mode and a rigid supporting piece (41) used for limiting deformation of the rigid supporting section (4), two ends of the flexible supporting piece (31) are respectively connected with the rigid supporting piece (41) and the steering section (1), and the flexible supporting piece (31) can deflect along with the flexible supporting section.
4. The guidewire of claim 3,
the hole axis (N) of the turning section (1) deviates from the hole axis (Q) of the flexible supporting section (3), so that the turning section (1) and the flexible supporting section (3) have different deflection directions when the pressure in the pipe hole (101) is increased;
or the like, or, alternatively,
the bore axis (N) of the turning section (1) coincides with the bore axis (Q) of the flexible support section (3);
wherein the bore axis (Q) of the flexible support section (3) coincides with a bore axis (M) of the guidewire body (100).
5. The guidewire of claim 3,
the hole axis (N) of the steering section (1) and the hole axis (Q) of the flexible supporting section (3) are respectively positioned at two opposite sides of an XP' Z plane;
or, the hole axis (N) of the turning section (1), the hole axis (Q) of the flexible support section (3) are located on opposite sides of a YP' Z plane, respectively;
wherein P' is any point on the central axis (P).
6. The guidewire of claim 3,
the bore axis (N) of the turnaround section (1) lies in the XP 'Z plane and the bore axis (Q) of the flexible support section (3) lies in the YP' Z plane;
wherein P' is any point on the central axis (P).
7. The guidewire of claim 3,
the plurality of protrusions (11) are arranged in the pipe hole of the turning section (1) at equal intervals.
8. The guidewire of any one of claims 3-7,
the rigid supporting piece (41) is a supporting pipe, and the supporting pipe is arranged in the pipe hole (101) of the rigid supporting section (4) in a penetrating mode or sleeved on the rigid supporting section (4).
9. The guidewire of any one of claims 3-7,
the flexible support (31) is a spring, the spring index of which increases in the axial direction of the support section (2) and in the direction from the open end (105) to the closed end (104).
10. The guidewire of claim 3,
the flexible supporting section (3) and the turning section (1) are both provided with developing elements, and
the developing element is positioned on one side of the flexible supporting section (3) close to the opening end (105), one side of the turning section (1) close to the closed end (104) and the joint of the flexible supporting section (3) and the turning section (1).
11. The guidewire of claim 2,
the cross section of the bulge (11) is in any one shape of triangle, arc and trapezoid.
12. The guidewire of claim 2,
the outermost layer of the guidewire is coated with a hydrophilic coating.
13. The guidewire of any one of claims 3-7,
the range of the deflection angle theta of the guide wire is 0-120 degrees.
14. The guidewire of any one of claims 3-7,
the diameter range of the guide wire is 0.4 mm-1 mm.
15. A vascular access device comprising:
the guidewire of any one of claims 1-14;
a pressure regulating device (200), an output end of the pressure regulating device (200) is connected with the opening end (105) of the guide wire body to regulate the pressure in the pipe hole (101) of the guide wire body (100).
16. Vascular access device according to claim 15,
the pressure regulating device (200) comprises:
the output end of the pressure pump (20) is connected with a connecting pipe (21), and the connecting pipe (21) is connected with the opening end (105);
and the pressure gauge (23) is connected to the output end of the pressure pump (20) and is used for detecting the pressure value in the pipe hole (101).
17. Vascular access device according to claim 15,
the pressure pump (20) is a balloon dilatation pressure pump.
18. A vascular intervention method, wherein the method is applied to the guide wire according to any one of claims 1 to 14;
when the closed end (104) of the guide wire body (100) reaches a branch vessel (b) communicated with a vessel (a), the pressure in the tube hole (101) is increased, and the guide wire body (100) is deflected to enter the branch vessel (b).
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111518563.6A CN114344677B (en) | 2021-12-10 | 2021-12-10 | Guide wire, blood vessel intervention method thereof and blood vessel intervention device |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111518563.6A CN114344677B (en) | 2021-12-10 | 2021-12-10 | Guide wire, blood vessel intervention method thereof and blood vessel intervention device |
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| Publication Number | Publication Date |
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| CN114344677A true CN114344677A (en) | 2022-04-15 |
| CN114344677B CN114344677B (en) | 2023-03-03 |
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| CN116440389A (en) * | 2023-06-20 | 2023-07-18 | 北京普益盛济科技有限公司 | Microtubule structure, microcatheter and method for manufacturing microtubule structure |
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|---|---|
| CN114344677B (en) | 2023-03-03 |
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