CN114904121A

CN114904121A - Medical leading-in tube, guiding catheter device thereof and radial artery access catheter system

Info

Publication number: CN114904121A
Application number: CN202210435666.4A
Authority: CN
Inventors: 刘建明; 林植东; 王昂
Original assignee: Guangzhou Yijie Medical Technology Co ltd
Current assignee: Guangzhou Yijie Medical Technology Co ltd
Priority date: 2022-04-24
Filing date: 2022-04-24
Publication date: 2022-08-16
Anticipated expiration: 2042-04-24
Also published as: CN114904121B

Abstract

The invention relates to a medical introducing pipe, which comprises a pipe body divided into a near-end supporting section and a far-end flexible section, wherein the pipe body comprises an inner lining layer and an outer pipe layer, and the hardness of the outer pipe layer is gradually enhanced from the tail end of the far-end flexible section to the tail end of the near-end supporting section; the outer tube layer is divided into at least eight sections in the area of the far-end flexible section, and the hardness of the section far away from the near-end support section is smaller than that of the section near the near-end support section. Outer pipe layer hardness of body supports the section from the gentle section of distal end to near-end and strengthens gradually, the gentle section of distal end divide into eight section at least pipe sections, let the near-end support section have strong holding power, and the gentle section of distal end can have compliance and slight support performance concurrently, let the soft section of distal end bear the power that comes from the near-end support section better, make under the terminal hardness lower's of the soft section of distal end the condition, the compliance reaches better and can also reach the target position and can not take place distortion or stagnation.

Description

Medical leading-in tube, guiding catheter device thereof and radial artery access catheter system

Technical Field

The invention relates to the field of medical instruments, in particular to a medical leading-in tube, a guiding catheter device thereof and a radial artery access catheter system.

Background

The medical introducing tube is a common medical instrument in interventional therapy, wherein a femoral artery (TFA) access is used as a conventional operation access in a nerve interventional diagnosis and treatment process, and the medical introducing tube has the characteristics of simplicity in operation and high puncture success rate. However, after conventional femoral artery puncture, patients often need to be strictly bedridden and have limited activities, and complications such as lower limb venous thrombosis, local hematoma, pseudo-aneurysm, lumbago, urinary retention and the like are easy to occur. Meanwhile, if the patient has contraindications such as severe tortuosity, stenosis, occlusion of the femoral iliac artery or thoracic and abdominal aorta, or vascular variation and tortuosity on the aortic arch, the TFA nerve intervention operation cannot be performed. Therefore, some cerebrovascular intervention centers at home and abroad are trying to develop DSA and interventional therapy by radial artery access (TRA). Adopts the neural intervention diagnosis and treatment through the radial approach, has the advantages of no need of lying in bed, less puncture complications and the like, and greatly improves the comfort and acceptability of patients.

However, the existing catheter is designed according to the femoral artery access, so when the catheter is applied to the radial artery access or other nerve intervention modes, the problems of insufficient support and poor positioning performance of the catheter occur. The insufficient support refers to that the catheter is easy to bend or kink in pushing and pulling under the action of external force during the process of heading to a target area, so that the movement of the catheter deviates. The poor availability means that the operator can hardly reach the target position after applying a pushing force at the proximal end and encountering a bifurcation, a lesion or a situation of decaying and twisting due to the transmission of force during the process of advancing the catheter in the blood vessel.

Disclosure of Invention

The invention aims to overcome the problems of poor support property and poor in-place property of the existing catheter in other interventional modes, and provides a medical guide tube which improves the support property and in-place property of the catheter by improving the flexibility of the far end of the catheter and the support strength of the near end of the catheter.

In order to solve the technical problems, the invention adopts the technical scheme that: the flexible pipe comprises an inner lining layer and an outer pipe layer, wherein the outer pipe layer comprises a near-end support section and a far-end flexible section; the distal flexible section is divided into a plurality of sections of different hardness, and the hardness of each section of the distal flexible section gradually decreases from the boundary position with the proximal support section along the axial direction of the section of the distal flexible section.

In the above technical solution, the user applies force to the proximal end support section, and by pushing the proximal end support section outside the human body, the tube body moves forward in the blood vessel of the human body and the distal end of the distal end flexible section reaches the target position. Because the hardness of the outer pipe layer of the pipe body is harder near the tail end of the near-end support section, when a user pushes the near-end support section outside the human body, acting force can be better transmitted to the whole pipe body, and the pipe body does not deviate in motion. Divide into the regional pipeline section of a plurality of different hardnesses with the gentle section of distal end, let the soft section of distal end hardness transition more natural and have compliance and slight support performance concurrently, let the soft section of distal end bear the power that comes from the near-end support section better and carry out the transmission for under the terminal hardness lower condition of distal end soft section, the compliance reaches better and can also reach the target location and can not take place distortion or stagnation.

The outer tube layer can be made of medical polymer materials with gradually changed hardness, such as nylon, polyurethane or block polyether amide, and the outer tube layer can be made in a mode of 3D printing integrated forming or splicing after multi-section forming.

Preferably, the distal flexible section is divided into at least 8 sections of different hardness, each section having a hardness gradually decreasing along its axis from a boundary with the proximal support section. The soft section of distal end divide into 8 sections at least, and the change of its hardness can pass through more naturally, makes the power transmission effect of the soft section of distal end better.

Preferably, the length of two segments of the outer tube layer close to the end far away from the proximal support segment in the region of the distal flexible segment is 50-70mm, and the length of the distal flexible segment is enough to reach the target position after turning in the blood vessel. The sum of the lengths of the rest at least six sections is 15-35mm, so that the hardness change between the far-end flexible section and the near-end supporting section is more natural, and the force transmission effect is better.

Preferably, the pipe body is further provided with a reinforcing layer between the inner liner layer and the outer pipe layer, a reinforcing structure is arranged in the reinforcing layer, and the reinforcing structure can be a spring ring, a woven layer or one or more of the combination of the spring ring and the woven layer; the spring ring and the braided fabric are formed by winding or braiding wires. The support performance of the pipe body is further enhanced through the reinforcing structure of the reinforcing layer. The spring ring can be made by single wire winding spring, double wire winding spring or triple wire winding spring, while the braided layer can be made by one-pressing two-pressing braiding mode. And the material of the wire used for making the spring coil or the woven layer can be NiTi, SUS304 and the like.

Preferably, the wire material is a variable diameter wire material and comprises at least one section of wire material unit, and the variable diameter wire material can be a round wire, a rectangular flat wire or an elliptical flat wire. The diameter, the width or the thickness of the wire material with the variable diameter is not constant, specifically, the size values of the diameter, the width or the thickness and the like from one end to the other end of the wire material are gradually increased from one threshold value to another specific threshold value, or the wire material is in a continuous alternating mode of increasing first and then decreasing and then increasing. The silk material is behind preparation spring coil or weaving layer, when promoting the tractive body, the inside of spring coil and weaving layer also can take place relative displacement, spring coil and weaving layer all can take place deformation after the atress, deformation that takes place this moment in spring coil and weaving layer is equivalent to the effect that lets spring coil and weaving layer produce certain suction buffering, and take place on the body when this effect, can lead to the user to apply the power at the body and can be absorbed, it transmits to the gentle soft section of distal end to lead to power to be difficult to from near-end support section, the soft section of distal end does not take place to remove or does not reach anticipated removal effect after possibly applying certain power, then continue to increase and remove behind the applied force and exceeded anticipated removal effect again, the motion is inaccurate, the user is difficult to the control.

And adopt the reducing silk material, after reducing silk material support spring ring or weaving layer, because its whole size is invariable, because frictional force between the silk material can increase under its inside microcosmic state for the deformation volume of both inside silk materials and silk material junction after the atress can obviously reduce. In addition, because the sizes of multiple points of the variable diameter wire are not consistent, the internal stress of the variable diameter wire is uneven in a microscopic state, and the relative displacement of the inside is reduced after external force is applied. Through reducing the inside deformation volume of silk material atress behind preparation spring coil or weaving layer to improve dynamics transmission efficiency, also reduce the probability of body of pipe deformation and make the motion of distal end soft section more accurate.

Preferably, the wire units are round wires, the threshold range of the minimum value and the maximum value of the diameters is 0.02-0.07mm, and the diameter difference of two adjacent wire units is 0.003-0.007 mm. The silk material includes silk material unit more than two sections, connects to the silk material through the mode of silk material unit through the concatenation.

Preferably, the wire unit is a rectangular flat wire, and comprises a large-size part, a small-size part and a gradual change part, wherein the large-size part and the small-size part are respectively positioned at two ends of the wire unit, and the gradual change part is used for connecting the large-size part and the small-size part; the thickness and the width of the small-size part are smaller than those of the large-size part; the thickness and the width of the gradually-changing part gradually increase from one end to the other end; the thickness and the width of one end, connected with the small-size part, of the gradual change part are consistent with the size of the small-size part, and the thickness and the width of one end, connected with the large-size part, of the gradual change part are consistent with the size of the large-size part. If the wire comprises multiple sections of wire units, the wire units can be spliced between a large-size part and a large-size part, spliced between a small-size part and a small-size part, and spliced between the large-size part and the small-size part. The rectangular flat wire can be manufactured in a 3D printing mode or a mode of locally pressing the round wire.

Preferably, the wire unit is an elliptical flat wire, the end faces of the two ends of the wire unit are elliptical, the major axis sizes of the two are consistent, and the minor axis sizes of the two are consistent; the size of one end of the oval flat wire is gradually changed to the other end, the size of the long axis of the oval end face at one end is gradually reduced to the size of the short axis of the end face at the other end, and the size of the short axis of the oval end face at one end is gradually increased to the size of the long axis of the end face at the other end. The oval flat wire rectangular flat wire can be manufactured in a 3D printing mode and a mode of locally pressing a round wire or twisting two ends of the round wire.

Preferably, the coil has a greater pitch proximate the distal flexible section than proximate the proximal support section; the thread pitch of the spring ring in the area of the distal soft section is 0.2-0.3mm, preferably 0.2 mm; the pitch in the region of the proximal support section is 0.1-0.2mm, preferably 0.1 mm. The proximal support section requires more support force and therefore the pitch of the proximal support section is smaller.

Preferably, the braid has a braid density near the distal flexible section that is less than a braid density near the proximal support section; the knitting density of the knitting layer in the region of the far-end soft section is 80-120 PPI; the knitting density of the area of the knitting layer located on the near-end supporting section is 60-80 PPI. The proximal support section requires more support force and therefore the braiding density of the proximal support section is greater.

Preferably, the coil or braid in the region of the proximal support section extends to both tube sections of the distal flexible section. The reinforcing structure of the proximal supporting section has better supporting force, when the reinforcing structure extends to two pipe sections of the distal soft section, the two pipe sections have better supporting performance, after entering a blood vessel, the two pipe sections can be better suspended in an arch area, and enough supporting force is provided for the distal soft section to enable the tail end of the distal soft section to reach a target position and to stably stay at the target position.

A guide catheter device comprises a joint, a stress release piece connected with the joint and the medical guide catheter, wherein one end of the stress release piece, far away from the joint, is connected with the medical guide catheter.

A radial artery access catheter system comprises a Y valve, a selection tube and the guide catheter device, wherein the selection tube and the guide catheter device are positioned at two ends connected with the Y valve, and the axes of the selection tube, a medical leading-in tube of the guide catheter device and the Y valve are collinear.

Compared with the prior art, the invention has the beneficial effects that:

(1) outer pipe layer hardness of body supports the section from the gentle section of distal end to near-end and strengthens gradually, the gentle section of distal end divide into eight section at least pipe sections, let the near-end support section have strong holding power, and the gentle section of distal end can have compliance and slight support performance concurrently, let the soft section of distal end bear the power that comes from the near-end support section better, make under the terminal hardness lower's of the soft section of distal end the condition, the compliance reaches better and can also reach the target position and can not take place distortion or stagnation.

(2) The enhancement layer is filled with the enhancement structure that adopts the reducing silk material to make, makes the power transmission efficiency of enhancement structure promote, has reduced the probability of pipe shaft deformation simultaneously and has made the motion of the gentle section of distal end more accurate.

Drawings

FIG. 1 is a schematic view showing the structure of example 1 of a medical introducing tube of the present invention;

FIG. 2 is a schematic view showing the structure of example 2 of a medical introducing tube of the present invention;

FIG. 3 is a schematic view showing the structure of example 3 of a medical introducing tube of the present invention;

FIG. 4 is a schematic structural view of an embodiment of a wire of the rectangular flat wire of the present invention;

FIG. 5 is a schematic structural view of another embodiment of the wire of the rectangular flat wire of the present invention;

FIG. 6 is a schematic view of an embodiment of a wire of the oblong rectangular wire of the present invention;

FIG. 7 is a schematic view of another embodiment of the wire of the oblong rectangular wire of the present invention;

FIG. 8 is a schematic structural view of a guiding catheter device of the present invention;

FIG. 9 is a schematic view of a use scenario of a radial access catheter system of the present invention;

FIG. 10 is a partial enlarged view of the position A of FIG. 9;

FIG. 11 is a schematic view showing a structure of a medical introducing tube according to the present invention, in which a modified developing ring is provided at a distal end thereof;

FIG. 12 is a view showing a state in which a modified developing ring is provided at the distal end of a medical introducing tube according to the present invention.

The parts in the drawings are numbered as follows:

1-an inner liner layer; 2-outer tube layer; 201-a proximal support section; 202-distal soft segment; 3-a reinforcing layer; 301-spring coils; 302-woven layer; 4-rectangular flat wire; 401-large size part; 402-small size section; 403-transition portion; 5-elliptical flat wire; 6-a linker; 7-a stress relief; 8, a medical leading-in tube; 801-first circle of development; 802-second development circle, 803-development connecting filament; a 9-Y valve; 10-selection tube; 11-stiffened guide wire.

Detailed Description

The drawings are for illustrative purposes only and are not to be construed as limiting the patent; for the purpose of better illustrating the embodiments, certain features of the drawings may be omitted, enlarged or reduced, and do not represent the size of an actual product; it will be understood by those skilled in the art that certain well-known structures in the drawings and descriptions thereof may be omitted. The positional relationships depicted in the drawings are for illustrative purposes only and are not to be construed as limiting the present patent.

The same or similar reference numerals in the drawings of the embodiments of the present invention correspond to the same or similar components; in the description of the present invention, it should be understood that if there are terms such as "upper", "lower", "left", "right", "long", "short", etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the drawings, it is only for convenience of description and simplicity of description, but does not indicate or imply that the device or element referred to must have a specific orientation, be constructed in a specific orientation, and be operated, and therefore, the terms describing the positional relationships in the drawings are only used for illustrative purposes and are not to be construed as limitations of the present patent, and specific meanings of the terms may be understood by those skilled in the art according to specific situations.

The technical scheme of the invention is further described in detail by the following specific embodiments in combination with the attached drawings:

example 1

As shown in fig. 1, an embodiment 1 of a medical introducing tube comprises an inner liner layer 2 and an outer tube layer 3, wherein the outer tube layer 2 comprises a proximal support section 201 and a distal flexible section 202, and the hardness of the distal flexible section 202 of the outer tube layer 2 is gradually reduced from a boundary position with the proximal support section 201 along the axial direction thereof; the distal flexible section 202 is divided into several sections of different stiffness, each section having a stiffness that decreases from the interface with the proximal support section 201 along its axis. The hardness value of the outer pipe layer 2 is gradually increased from one end to the other end within the range of 35A-72D; the outer tubular layer 3 is divided into at least eight segments in the area of the distal flexible section 202, and the segments distal from the proximal support section 201 have a stiffness lower than the stiffness of the segments proximal to the proximal support section 201. The tube segment of this embodiment is provided with eight segments, a-h from the end near the proximal support segment 201 to the distal flexible segment 202.

Specifically, the length of two segments of the outer tube layer 3 near the end far away from the proximal support segment 201 in the region of the distal flexible segment 202 is 50-70mm, i.e. the sum of the lengths of the g segment and the h segment is 50-70mm, specifically 60mm in this embodiment; at this length, the distal flexible section 202 is still long enough to reach the target site after the endovascular turn. The sum of the lengths of the rest at least six sections of pipe sections is 15-35mm, namely the total length of the sections a-f is 15-35mm, in the embodiment, 25 mm. The hardness change between the distal soft segment 202 and the proximal support segment 201 is more natural and the force transmission effect is better.

The working principle or working flow of the embodiment is as follows:

the user applies force to the proximal support section 201, which is still outside the body, to move the tube forward in the body vessel and bring the distal end of the distal flexible section 202 to the target position by pushing the proximal support section 201. Because the hardness of outer pipe layer 3 of body is close to the end that the near-end supported section 201 just more hard, lets the user when the human outer near-end of propelling movement supports section 201, and the effort can better transmit whole body, lets the body not take place the skew in the motion. The region of the distal soft segment 202 is divided into at least eight segments, so that the hardness transition of the distal soft segment 202 is more natural and has both flexibility and light support performance, and the distal soft segment 202 better bears the force from the proximal support segment 201, so that under the condition that the hardness of the distal soft segment 202 is lower, the flexibility is better and can reach the target position without distortion or stagnation.

The effective results of this example: outer pipe layer 2 hardness of body supports section 201 from distal end soft section 202 to near-end and strengthens gradually, distal end soft section 202 divide into eight section at least pipe sections, let near-end support section 201 have strong holding power, and distal end soft section 202 can have compliance and slight support performance concurrently, let distal end soft section 202 bear the power that comes from near-end support section 201 better, make under the circumstances that the terminal hardness of distal end soft section 202 is lower, the compliance reaches better and can also reach the target position and can not take place distortion or stagnation.

Example 2

Embodiment 2 of a medical inlet tube is different from embodiment 1 in that, as shown in fig. 2, a reinforcing layer 4 is further provided between the inner lining layer 2 and the outer tubular layer 3, and a reinforcing structure is provided in the reinforcing layer 4, wherein the reinforcing structure is a coil 301. The support performance of the pipe body by the reinforcing structure of the reinforcing layer 4 is further enhanced. The spring ring 301 may be made of a single wire wound spring, a double wire wound spring, or a triple wire wound spring, and the wire used to make the spring ring 301 may be NiTi.

Specifically, the pitch of the spring coil 301 near the distal flexible section 202 is greater than the pitch near the proximal support section 201; the pitch of the coil 301 in the region of the distal soft segment 202 is 0.2 mm; the pitch in the region of the proximal support section 201 is 0.1 mm. The proximal support section 201 requires more support force and therefore the pitch of the proximal support section 201 is smaller.

The remaining operation principle and advantageous effects of this embodiment are the same as those of embodiment 1.

Example 3

Embodiment 3 of a medical introducing pipe is different from embodiment 1 in that, as shown in fig. 3, a reinforcing layer 4 is further provided between an inner lining layer 2 and an outer pipe layer 3, and a reinforcing structure is provided in the reinforcing layer 4, and the reinforcing structure is a braided layer 302. The support performance of the pipe body by the reinforcing structure of the reinforcing layer 4 is further enhanced. The braided layer 302 may be formed by one-over-one, one-over-two or two-over-two braiding, and the wire used to form the braided layer 302 may be SUS 304.

Specifically, the braid density of the braid 302 near the distal flexible section 202 is less than the braid density near the proximal support section 201; the braid 302 has a braid density of 100PPI in the region of the distal soft segment 202; the braid 302 has a braid density of 60PPI in the region of the proximal support section 201. The proximal support section 201 requires a greater support force and therefore the braiding density of the proximal support section 201 is greater.

The remaining operational principle and advantageous effects are the same as those of embodiment 1.

Example 4

An embodiment 4 of a medical introducing pipe is different from the embodiment 1 in that a reinforcing layer 4 is further disposed between an inner lining layer 2 and an outer pipe layer 3, a reinforcing structure is disposed in the reinforcing layer 4, the reinforcing structure is a combination of a spring coil 301 and a woven layer 302, wherein the spring coil 301 can be made in a single wire wound spring, a double wire wound spring or a triple wire wound spring, and a material of a wire material used for making the spring coil 301 can be NiTi. The braided layer 302 may be formed by one-over-one, one-over-two or two-over-two braiding, and the wire used to form the braided layer 302 may be NiTi or SUS 304.

In this embodiment, the reinforcing structure that the spring coil 301 and the braided layer 302 combine has higher holding power than the reinforcing structure that only has spring coil 301 or braided layer 302, and in order to let the body have better support performance and simultaneously let distal end soft section 202 have good compliance, the reinforcing structure that enhancement layer 4 is located 20 ~ 40mm department at distal end soft section 202 is spring coil 301 or braided layer 302 only.

Example 5

An embodiment 5 of a medical inlet tube differs from any of embodiments 2 to 4 in that the wire is a variable diameter wire and includes at least one segment of wire unit, and the variable diameter wire may be a round wire, a rectangular flat wire or an elliptical flat wire. The diameter, the width or the thickness of the wire material with the variable diameter is not constant, specifically, the size values of the diameter, the width or the thickness and the like from one end to the other end of the wire material are gradually increased from one threshold value to another specific threshold value, or the wire material is in a continuous alternating mode of increasing first and then decreasing and then increasing. After the wire material is made into the spring coil 301 or the woven layer 302, when the pulling tube body is pushed, the inner parts of the spring coil 301 and the woven layer 302 can also generate relative displacement, the spring coil 301 and the woven layer 302 can both generate deformation after being stressed, the deformation generated in the spring coil 301 and the woven layer 302 at the moment is equivalent to a certain suction buffering effect generated by the spring coil 301 and the woven layer 302, and when the effect is generated on the tube body, the force applied to the tube body by a user can be absorbed, the force is difficult to be transmitted to the far-end soft section 202 from the near-end supporting section 201, the far-end soft section 202 does not move or does not reach the expected moving effect after the certain force is possibly applied, then the force is continuously increased and then moves beyond the expected moving effect, the movement is inaccurate, and the user is difficult to control.

And adopt the reducing silk material, after reducing silk material support spring coil 301 or weaving layer 302, because its whole size is invariable, because the frictional force between the silk material can increase under its inside microcosmic state for the deformation volume of both inside silk material and silk material junction after the atress can obviously reduce. In addition, because the sizes of multiple points of the variable diameter wire are not consistent, the internal stress of the variable diameter wire is uneven in a microscopic state, and the relative displacement of the inside is reduced after external force is applied. The internal deformation amount of the stress of the wire materials after the spring coil 301 or the woven layer 302 is manufactured is reduced, so that the force transmission efficiency is improved, and the deformation probability of the tube body is reduced, so that the movement of the far-end soft section 202 is more accurate.

The remaining principles of operation and benefits of this embodiment are consistent with any of the embodiments described above.

Example 6

Example 6 of a medical inlet tube differs from example 5 in that the wire material in this example is formed by connecting a plurality of wire material units, the wire material units are round wires, the threshold value ranges of the minimum value and the maximum value of the diameters are 0.02 to 0.07mm, the difference in the diameters of the adjacent two wire material units is 0.003 to 0.007mm, and the length of each wire material unit is 20 to 25 mm.

The remaining operation principle and advantageous effects of this embodiment are the same as those of embodiment 5.

Example 7

An embodiment 7 of a medical introducer tube is different from the embodiment 5 in that a wire and a wire unit are further defined, as shown in fig. 4, the wire has only one segment of the wire unit, the wire unit is a rectangular flat wire 4, and the wire unit includes a large-size portion 401, a small-size portion 402 and a gradually changing portion 403 for connecting the large-size portion 401 and the small-size portion 402 at both ends; the thickness and width of the small-size portion 402 are smaller than those of the large-size portion 401; the thickness and width of the gradation portion 403 gradually increase from one end to the other end; the thickness and width of the tapered portion 403 connecting one end of the small-size portion 402 coincide with the size of the small-size portion 402, and the thickness and width of the tapered portion 403 connecting one end of the large-size portion 401 coincide with the size of the large-size portion 401.

In the present embodiment, the thickness W1 of the large-size portion 401 is 0.07, and the width L1 is 0.1; the small-sized portion 402 has a thickness W2 of 0.02 and a width L2 of 0.05.

Example 8

Example 8 of a medical introducing tube is different from example 7 in that the wire material is formed by connecting a plurality of rectangular flat wires 4 as shown in FIG. 5. In this embodiment, the splicing between the filament units is performed between the large-size portion 401 and the large-size portion 401, and between the small-size portion 402 and the small-size portion 402.

The remaining operation principle and advantageous effects of this embodiment are the same as those of embodiment 7.

Example 9

An embodiment 9 of a medical inlet tube is different from the embodiment 5 in that, as shown in fig. 6, a wire and a wire unit are further defined, the wire has only one section of the wire unit and the wire unit is an elliptical flat wire 5, end faces of both ends of the wire unit are elliptical, and the major axis and the minor axis of the wire unit are the same; the size of one end of the oval flat wire 5 is gradually changed to the other end, the size of the long axis of the oval of one end face is gradually reduced to the size of the short axis of the other end face, and the size of the short axis of the oval of one end face is gradually increased to the size of the long axis of the other end face.

In this embodiment, the major axis is 0.05-0.07mm and the minor axis is 0.02-0.04 mm.

Example 10

Example 10 of a medical introducing tube is different from example 9 in that wire members are formed by connecting a plurality of stages of elliptical flat wires 5 as shown in FIG. 7.

The remaining operation principle and advantageous effects of this embodiment are the same as those of embodiment 9.

Example 11

Example 11 of a medical introducer tube differs from any of examples 2-10 in that the coil 301 or braid 302 in the area of the proximal support section 201 extends over two tube segments, namely segment a and segment b, of the distal flexible section 202. The reinforcing structure of the proximal support section 201 has better supporting force, and when it extends to two tube sections of the distal flexible section 202, the two tube sections have better supporting performance, and after entering the blood vessel, the two tube sections can be better suspended in the arch region, so as to provide enough supporting force for the distal flexible section 202 to make the end of the distal flexible section 202 reach the target position and stably stay at the target position.

The remaining features and operating principles of this embodiment are consistent with any of embodiments 2-10.

Example 12

An embodiment of a guiding catheter device, as shown in fig. 8, comprises a connector 6, a stress relief member 7 connected with the connector 6, and a medical introducing pipe 8 as described in any one of embodiments 1-11, wherein one end of the stress relief member 7, which is far away from the connector, is connected with the medical introducing pipe.

Example 13

An embodiment of a radial artery access catheter system, as shown in fig. 9-10, comprises a Y-valve 9, a selection tube 10 and a guiding catheter device of embodiment 12, the selection tube 10 and the guiding catheter device are positioned at two ends of the Y-valve 9, and the axes of the selection tube 10, a medical introducing tube 8 of the guiding catheter device and the Y-valve 9 are collinear.

As shown in fig. 9-10, in this embodiment, for example, a left carotid artery intervention operation is performed on an aortic arch type I, a coaxial system is composed of a Y-valve 9, a selection tube 10, a medical introduction tube 8 and a stiffened guide wire 11, and the coaxial system is ascended from a right radial artery to a right clavicular artery. At the moment, the tube body is kept at the position of the right clavicular artery, the selection tube 10 and the stiffened guide wire 11 are pushed, the superior branch of the arch is selected and indicated by the left carotid artery, and the selection tube 10 and the stiffened guide wire 11 are continuously pushed to the bifurcation position of the internal carotid artery and the external carotid artery and are kept at the position. Subsequently, the medical introducing tube is pushed along the selection tube 10 and the stiffened guide wire 11 to the target vascular site. Finally, the selection tube 10 and the stiffening guidewire 11 are withdrawn. At this point, the right radial artery to target cerebral vascular access is complete. By means of the access, interventional treatment of hemorrhagic or ischemic diseases in neurovascular system is possible.

As shown in fig. 11 to 12, the medical introducing tube according to any one of embodiments 1 to 11 can be further optimized in that, since the end of the conventional medical introducing tube near the distal end is provided with the developing ring, such as a developing ring, generally has a certain hardness and extends in the axial direction, and therefore, if the requirement for the radius of the bend is small, the position of the conventional medical introducing tube with the developing ring cannot always pass smoothly, and in view of this, the optimized solution is specifically that, at the end of the medical introducing tube 8 near the distal end, the first developing ring 801 and the second developing ring 802 are modified to be displaced in the axial direction by a certain amount, and the developing connecting wire 803 is provided between the first developing ring 801 and the second developing ring 802, compared with the conventional solution, on the premise that the same axial length is occupied, the improved structure does not affect the observation definition of an operator, and can improve the passing performance of the pipe section in the bent blood vessel; of course, the present preferred embodiment can also be implemented by replacing the first developing ring 801, the developing connecting wire 803, the second developing ring 802, and the developing connecting wire 803 mentioned above with one developing wire to form a structure of a tightly wound roll portion-an unwounded roll portion-a tightly wound roll portion, and thus, the effects similar to those disclosed in the above preferred embodiment can also be achieved. The developing ring, the developing wire and other developing parts which are not mentioned in the invention are made of metal or alloy materials which are easy to develop under the X-ray environment.

It should be understood that the above-described embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. Any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. A medical leading-in pipe comprises a lining layer (1) and an outer pipe layer (2), wherein the outer pipe layer (2) comprises a near-end support section (201) and a far-end flexible section (202), and is characterized in that the hardness of the far-end flexible section (202) of the outer pipe layer (2) is gradually reduced from the boundary position with the near-end support section (201) along the axial direction of the far-end flexible section; the distal flexible section (202) is divided into a plurality of sections of different hardness, and the hardness of each section of the distal flexible section gradually decreases from the boundary position with the proximal support section (201) along the axial direction of the section of the distal flexible section.

2. The medical introducer of claim 1, wherein the distal flexible section (202) is divided into at least 8 sections of different stiffness, each section having a stiffness that decreases from a boundary with the proximal support section (201) along its axis.

3. The medical introducer according to claim 1, wherein two of the tube sections of the outer tube layer (2) near the end distal to the proximal support section (201) in the region of the distal flexible section (202) have a length of 50-70mm, and the sum of the lengths of the remaining at least six tube sections is 15-35 mm.

4. The medical lead-in tube according to claim 2, characterized in that a reinforcing layer (3) is further arranged between the inner lining layer (1) and the outer tube layer (2); a reinforcing structure is arranged in the reinforcing layer (3), and the reinforcing structure can be one or more of a spring coil (301), a woven layer (302) or the combination of the spring coil (301) and the woven layer (302); the spring ring (301) and the braided fabric are respectively formed by winding or braiding wires.

5. The medical introducer of claim 4, wherein the wire is a variable diameter wire and comprises at least one length of wire units.

6. The medical introducer of claim 5, wherein the wire units are round wires, and the difference between the diameters of two adjacent wire units is 0.003-0.007 mm.

7. The medical introducer according to claim 5, wherein the wire unit is a rectangular flat wire (4), and the wire unit includes a large-sized portion (401), a small-sized portion (402), and a tapered portion (403) for connecting the large-sized portion (401) and the small-sized portion (402), at both ends, respectively; the thickness and width of the small-sized portion (402) are smaller than those of the large-sized portion (401); the thickness and width of the gradually changing portion (403) gradually increase from one end to the other end; the thickness and width of the gradually-changing portion (403) connecting one end of the small-size portion (402) are consistent with the size of the small-size portion (402), and the thickness and width of the gradually-changing portion (403) connecting one end of the large-size portion (401) are consistent with the size of the large-size portion (401).

8. The medical introducer tube according to claim 5, wherein the wire unit is an elliptical flat wire (5), the end faces of both ends of the wire unit are elliptical, and the major axis and the minor axis of the wire unit are the same; the size of one end of the oval flat wire (5) is gradually changed to the other end, the size of the long axis of the oval end face at one end is gradually reduced to the size of the short axis of the end face at the other end, and the size of the short axis of the oval end face at one end is gradually increased to the size of the long axis of the end face at the other end.

9. An introducer catheter device comprising a hub and a strain relief member coupled to the hub, and further comprising the medical introducer tube of any of claims 1-8, wherein an end of the strain relief member distal to the hub is coupled to the medical introducer tube.

10. A radial artery access catheter system comprising a Y-valve and a selector tube, further comprising the guide catheter device of claim 9, wherein said selector tube and said guide catheter device are located at opposite ends of said Y-valve, and wherein the axes of said selector tube, a medical introducer tube of said guide catheter device, and said Y-valve are collinear.