Medical catheter

Abstract

The invention provides a medical catheter which comprises a catheter body assembly, the catheter body assembly comprises a catheter body and an adjusting mechanism, the catheter body comprises an inner-layer tube and an outer-layer tube which are arranged from inside to outside, and a containing cavity is formed between the inner-layer tube and the outer-layer tube; the adjusting mechanism comprises a supporting layer and an adjusting wire, the supporting layer is arranged in the containing cavity and arranged on the inner-layer tube in a sleeving mode, and the near end of the supporting layer and the tube body are kept static relatively; the adjusting wire extends in the axial direction of the tube body, and the far end of the adjusting wire is connected with the far end of the supporting layer; the adjusting wire can generate axial movement relative to the tube body and drive the far end of the supporting layer to generate axial movement relative to the tube body, so that the material coverage rate of the far end of the supporting layer is at least changed, and then the rigidity of the far end of the tube body assembly is at least changed. The rigidity of the far end of the medical catheter can be adjusted according to the actual condition of the blood vessel, so that the far end of the medical catheter has good flexibility under the condition that the pushing force is met, and the medical catheter can smoothly pass through the tortuous and narrow blood vessel.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to a medical catheter. Background Art

[0002] Medical catheters are an important tool for intravascular treatment. Take transhepatic arterial chemoembolization (TACE) as an example. TACE is to inject embolic agents into the blood supply artery of the tumor through a medical catheter, blocking the blood supply of the tumor through the blood supply artery of the tumor, thereby causing ischemia and hypoxia of the tumor, achieving the purpose of inhibiting tumor growth and promoting tumor cell necrosis and apoptosis.

[0003] During TACE surgery, the surgeon punctures the femoral artery, inserts an angiography catheter, and then retrogrades along the inferior vena cava to the celiac artery and the hepatic artery, and then performs DSA angiography to observe the location of the tumor and the distribution of blood vessels supplying the tumor. After determining the vascular path, the catheter is super-selected into the target artery supplying the tumor through the cooperation of the micro-guidewire and the medical catheter, and then the micro-guidewire is withdrawn, and finally the embolic agent is injected through the medical catheter.

[0004] Since the blood vessels at the lesion site are tortuous and narrow, the stiffness of the medical catheter should be appropriate, otherwise it is difficult for it to pass through the blood vessels at the lesion site. Generally, if the distal end of the medical catheter is too hard, its flexibility is poor and it is not easy to bend. However, if the distal end of the medical catheter is too soft, although it has good flexibility, there is a problem of insufficient pushing force. In other words, the stiffness of the medical catheter is an important factor in whether the TRCE operation can be carried out smoothly. Summary of the invention

[0005] The object of the present invention is to provide a medical catheter, the stiffness of which is adjustable, so that the stiffness can be adjusted according to actual needs during use, so that the medical catheter can smoothly pass through a tortuous and narrow lesion.

[0006] To achieve the above object, the present invention provides a medical catheter, including a tube body assembly, wherein the tube body assembly includes:

[0007] The tube body comprises an outer tube and an inner tube, wherein a receiving cavity is formed between the inner tube and the outer tube;

[0008] The adjusting mechanism comprises a supporting layer and an adjusting wire; the supporting layer is sleeved on the outer circumferential surface of the inner tube, and the proximal end of the supporting layer remains relatively stationary with respect to the tube body; the adjusting wire extends along the axial direction of the tube body, and is at least partially arranged in the accommodating cavity, and the distal end of the adjusting wire is connected with the distal end of the supporting layer; the adjusting wire is configured to be able to generate axial movement relative to the tube body, and drive the distal end of the supporting layer to generate axial movement relative to the tube body, so as to at least change the material coverage of the distal end of the supporting layer.

[0009] Optionally, the support layer includes a woven tubular network structure; and / or, the support layer includes a spring structure.

[0010] Optionally, the tube body assembly is configured such that when the material coverage of the support layer increases within a predetermined range, the stiffness of the tube body assembly decreases, and when the material coverage of the support layer decreases within the predetermined range, the stiffness of part of the tube body assembly increases.

[0011] Optionally, the support layer includes a first segment and a second segment; the first segment remains relatively stationary with respect to the tube body, and the material coverage of the first segment remains constant; the second segment is connected to the distal end of the first segment and can generate axial movement relative to the tube body.

[0012] Optionally, the regulating wire comprises a plurality of sub-regulating wires, the plurality of sub-regulating wires are arranged at intervals along the circumference of the tube body assembly, and the distal end of each sub-regulating wire is connected to the distal end of the supporting layer;

[0013] When all the sub-adjustment wires move synchronously in the same direction along the axial direction of the tube body, the adjustment wire drives the distal end of the support layer to move axially relative to the tube body; when a part of the sub-adjustment wires move from the proximal end to the distal end, the adjustment wire drives the distal end face of the support layer to rotate around a rotation axis, and the rotation axis is perpendicular to the axis of the tube body.

[0014] Optionally, the tube body assembly also includes a limit member, which is arranged in the accommodating cavity and remains relatively stationary with respect to the tube body; when the support layer has a maximum length in the axial direction of the tube body, the distance between the limit member and the distal end of the support layer is greater than zero; the limit member is provided with a plurality of channels extending through the axial direction of the tube body, and the plurality of channels are arranged at intervals along the circumference of the tube body and correspond one by one to the plurality of sub-adjustment wires; each of the sub-adjustment wires is partially passed through the corresponding channel.

[0015] Optionally, the limiting member includes a plurality of limiting tubes, which are arranged at intervals along the circumference of the tube body and correspond one-to-one to the plurality of sub-adjusting wires, and the lumen of each limiting tube constitutes one of the channels.

[0016] Optionally, the medical catheter also includes a handle assembly, which includes a shell and a drive mechanism; the shell sleeve is connected to the proximal end of the tube body assembly; the drive mechanism is partially disposed inside the shell and connected to the proximal end of the adjustment wire, and the drive mechanism is configured to drive the adjustment wire to produce axial movement relative to the tube body.

[0017] Optionally, the shell is provided with a plurality of through grooves, which are arranged at intervals along the circumference of the tube body assembly and correspond one-to-one to the plurality of sub-adjusting wires, and the through grooves extend along the axial direction of the tube body assembly; the driving mechanism comprises an annular structure, which is sleeved on the outer circumferential surface of the tube body assembly; a plurality of sub-driving parts are formed on the annular structure, which are distributed at intervals along the circumference of the tube body assembly and correspond one-to-one to the plurality of through grooves, and each sub-driving part extends from the corresponding through groove to the outside of the shell; the proximal end of each sub-adjusting wire is connected to a corresponding sub-driving part;

[0018] The medical catheter is configured such that when at least one of the sub-driving parts is subjected to an external force and drives the annular structure to make an axial movement relative to the tube body, the driving mechanism drives the adjusting wire to make an axial movement relative to the tube body.

[0019] Optionally, the annular structure is a regular polygon and includes a plurality of corners, and each of the corners constitutes a sub-driving unit.

[0020] Optionally, the tube body assembly also includes a developing element, which includes a first developing ring and a second developing ring, the first developing ring is connected to the distal end of the second segment, the second developing ring is sleeved on the outer circumferential surface of the supporting layer and is located at the junction of the first segment and the second segment, and the second developing ring is connected to the first segment; the distal end of the adjusting wire is connected to the first developing ring.

[0021] Compared with the prior art, the medical catheter of the present invention has the following advantages:

[0022] The aforementioned medical catheter includes a tube body assembly, which includes a tube body main body and an adjustment mechanism, wherein the tube body main body includes an inner tube and an outer tube arranged from the inside to the outside, and a receiving cavity is formed between the inner tube and the outer tube; the adjustment mechanism includes a support layer and an adjustment wire, wherein the support layer is arranged in the receiving cavity and sleeved on the outer circumferential surface of the inner tube, and the proximal end of the support layer remains relatively stationary with respect to the tube body main body; the adjustment wire extends along the axial direction of the tube body main body and is at least partially arranged in the receiving cavity, and the distal end of the adjustment wire is connected to the distal end of the support layer; the adjustment wire is configured to be able to generate axial movement relative to the tube body main body, and drive the distal end of the support layer to generate axial movement relative to the tube body main body, so as to at least change the material coverage rate of the distal end of the support layer, and thereby at least change the stiffness of the distal end of the tube body assembly. In this way, the stiffness of the distal end of the medical catheter can be adjusted as needed, so that it can have a stiffness adapted to the actual conditions of the blood vessels, and have good flexibility while satisfying the pushing force, so as to smoothly pass through tortuous and narrow blood vessels. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The accompanying drawings are used to better understand the present invention and do not constitute an improper limitation of the present invention.

[0024] Figure 1 It is a schematic diagram of the stiffness test results of the tube body components of three medical catheters in the prior art;

[0025] Figure 2 is a schematic diagram of the overall structure of a medical catheter provided according to an embodiment of the present invention;

[0026] Figure 3 is a cross-sectional schematic diagram of a tube body assembly of a medical catheter provided according to an embodiment of the present invention, wherein the adjusting wire is not shown in the figure;

[0027] Figure 4 is a schematic longitudinal cross-sectional view of a tube body assembly of a medical catheter provided according to an embodiment of the present invention;

[0028] Figure 5 is a partial structural schematic diagram of a tube body assembly of a medical catheter provided according to an embodiment of the present invention;

[0029] Figure 6 1 is a partial structural schematic diagram of a tube body assembly of a medical catheter provided according to an embodiment of the present invention, wherein the tube body body is not shown in the figure;

[0030] Figure 7 is a partial structural schematic diagram of a tube body assembly of a medical catheter provided according to an embodiment of the present invention, wherein the tube body body is not shown in the figure, and Figure 7 The parts shown are Figure 6 different;

[0031] Figure 8 is a partial structural schematic diagram of a medical catheter provided according to an embodiment of the present invention, wherein the diagram mainly shows a handle assembly;

[0032] Fig. 9 1 is a partial structural schematic diagram of a medical catheter provided according to an embodiment of the present invention, and the diagram mainly shows the connection relationship between the driving part and the regulating wire;

[0033] Fig.10 1 is a partial structural schematic diagram of a medical catheter provided according to an embodiment of the present invention, and the diagram mainly shows the connection relationship between the tube body assembly and the Luer connector.

[0034] [Description of reference numerals is as follows]:

[0035] 10-tube body assembly, 11-proximal tube body, 12-distal tube body, 100-tube body, 110-outer tube, 120-inner tube, 200-adjusting mechanism, 210-supporting layer, 211-first segment, 212-second segment, 220-adjusting wire, 221-sub-adjusting wire, 300-developing element, 310-first developing ring, 320-second developing ring, 410-limiting tube, 500-shell, 510-through groove, 600-driving mechanism, 610-sub-driving unit, 700-Rule connector, 800-guide head. DETAILED DESCRIPTION

[0036] The following is an explanation of the embodiments of the present invention by specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in the present embodiment only illustrate the basic concept of the present invention in a schematic manner, and only the components related to the present invention are shown in the figure instead of being drawn according to the number, shape and size of the components in the actual implementation. The type, quantity and proportion of each component in the actual implementation can be a random change, and the component layout type may also be more complicated.

[0037] In addition, each embodiment of the following description has one or more technical features, but this does not mean that the user of the present invention must implement all the technical features in any embodiment at the same time, or can only implement part or all of the technical features in different embodiments separately. In other words, under the premise that implementation is possible, those skilled in the art can selectively implement part or all of the technical features in any embodiment according to the disclosure of the present invention and according to the design specifications or implementation requirements, or selectively implement a combination of part or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0038] As used in this specification, the singular forms "a", "an", and "the" include plural objects, and the plural form "a plurality" includes more than two objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense that includes "and / or", unless the content clearly indicates otherwise, and the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and it can be a connection between two elements or an interactive relationship between two elements. Relational terms such as the terms "first", "second", etc. are only used to separate one entity or operation from another entity or sub-driver, and do not necessarily require or imply any such actual relationship or order between these entities or operations, nor do they indicate or imply relative importance or implicitly indicate the number of technical features indicated. It should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "axial", "radial", "circumferential" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0039] The terms "proximal end" and "distal end" in this article are used to describe the relative positions and orientations of the various elements and components of the medical device. Although non-restrictive, the "distal end" is usually the end of the medical device that first enters the patient's body during use, and the "proximal end" is the end opposite to the "distal end".

[0040] The medical catheter in the prior art includes a tube body assembly, which generally includes an inner tube, a support layer and an outer tube arranged in sequence from the inside to the outside, wherein the support layer is a tube mesh structure woven by wire or a spring structure wound by wire. The material coverage of the support layer is an influencing factor of the stiffness of the tube body assembly. The inventors have found that when the material coverage of the support layer increases within a predetermined range, the stiffness of the tube body assembly decreases, and if the material coverage of the support layer decreases within the predetermined range, the stiffness of the tube body assembly increases. For the tube mesh structure, the predetermined range is related to the material of the wire, the specification of the wire, the weaving method and the number of weaving strands. For the spring structure, the predetermined range is related to the material of the wire, the specification of the wire, and the number of strands during winding. In addition, the "material coverage" refers to the ratio of the area occupied by the wire material to the area of ​​the entire outer peripheral surface of the supporting layer on the outer peripheral surface (or inner peripheral surface) of the supporting layer. The area occupied by the wire material is equal to the area of ​​the outer peripheral surface of the supporting layer minus the area of ​​the gap portion.

[0041] When the support layer is the tubular mesh structure, and the material, size, weaving method and number of strands of the wire material are determined, the material coverage of the support layer is actually determined by the weaving density of the tubular mesh structure. In this article, the number of weaving nodes per 1 inch length in the axial direction of the support layer is used as the weaving density, and its unit is PPI.

[0042] In practice, the inventors used stainless steel wire to weave the support layer, and then prepared the tube body assembly in the prior art. The stainless steel wire is a flat wire with a size of 0.02mm*0.06mm, that is, the width of the cross section of the stainless steel wire is 0.06mm and the height is 0.02mm. The weaving method is 1 press 1, and the number of weaving strands is 16. The inventors prepared three tube body assemblies with three different weaving densities of the support layer, and numbered them as tube body assembly No. 1, tube body assembly No. 2 and tube body assembly No. 3, respectively, wherein the weaving density of the support layer of tube body assembly No. 1 is 102PPI, the weaving density of the support layer of tube body assembly No. 2 is 127PPI, and the weaving density of the support layer of tube body assembly No. 3 is 169PPI. The stiffness of the three tube body assemblies was tested, and the test conditions are shown in Table 1, and the test results are shown in Table 2 and Figure 1 As shown in Table 2, the maximum downforce in Table 2 indicates the force required for the tube assembly to produce the same degree of deformation. The greater the maximum downforce, the greater the rigidity of the tube assembly. Figure 1It can be determined that within the range of braiding density of 100 PPI to 170 PPI (i.e., in the axial direction of the support layer, the number of braiding nodes within the range of 1 inch length is 100 to 170), the greater the braiding density of the support layer, the smaller the maximum downward force of the tube body assembly, i.e., the smaller the rigidity of the tube body assembly. The smaller the rigidity of the tube body assembly, the softer it is, and the easier it is to pass through tortuous blood vessels.

[0043] Table 1 Test conditions

[0044]

[0045] Table 2 Test results

[0046]

[0047] Based on this, the inventor proposes a medical catheter, which includes a tube body assembly, and the tube body assembly includes a tube body body and an adjustment mechanism. The tube body body includes an outer tube and an inner tube arranged in the outer tube, and a receiving cavity is formed between the inner tube and the outer tube. The adjustment mechanism includes a support layer and an adjustment wire. The support layer is arranged in the receiving cavity and is sleeved on the outer circumferential surface of the inner tube, and the proximal end of the support layer and the tube body body remain relatively stationary. The adjustment wire extends along the axial direction of the tube body body and is partially arranged in the receiving cavity. The distal end of the adjustment wire is connected to the distal end of the support layer. The adjustment wire is configured to be able to move axially relative to the tube body body, so as to drive the distal end of the support layer to move axially relative to the tube body body, and at least change the material coverage of the distal end of the support layer, thereby at least changing the stiffness of the distal end of the tube body assembly. Therefore, when the medical catheter is in use, the stiffness of the distal end portion of the tube body assembly can be adjusted according to the actual situation of the target blood vessel, so that the distal end portion of the tube body assembly has good flexibility while having sufficient pushing force to smoothly pass through the target blood vessel.

[0048] In order to make the purpose, advantages and features of the present invention more clear, the present invention is further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in very simplified form and in non-precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. The same or similar reference numerals in the drawings represent the same or similar components.

[0049] Figure 2 The overall structure diagram of the medical catheter provided by one embodiment of the present invention is shown in FIG. Figure 2 The medical catheter includes a tube body component 10. Figure 3 A cross-sectional view of the tube body assembly 10 is shown, Figures 4 to 6A partial structural diagram of the tube body assembly 10 is shown, please refer to Figures 3 to 6 The tube body assembly 10 includes a tube body body 100 and an adjustment mechanism 200. The tube body body 100 includes an outer tube 110 and an inner tube 120 disposed inside the outer tube 110, and a receiving cavity is formed between the outer circumference of the inner tube 120 and the inner circumference of the outer tube 110. The adjustment mechanism 200 includes a support layer 210 and an adjustment wire 220. The support layer 210 is disposed in the receiving cavity and sleeved on the outer circumference of the inner tube 120, and the proximal end of the support layer 210 remains relatively stationary with the tube body body 100. The adjustment wire 220 extends along the axial direction of the tube body body 100 and is at least partially disposed in the receiving cavity. The distal end of the adjustment wire 220 is connected to the distal end of the support layer 210. The adjustment wire 220 is configured to be able to generate axial movement relative to the tube body 100, and drive the distal end of the support layer 210 to generate axial movement relative to the tube body 100, so as to at least change the material coverage of the distal end of the support layer 210, and thereby at least change the stiffness of the distal end of the tube body assembly 10.

[0050] That is, when the medical catheter is used to perform intravascular treatment, the adjustment wire 220 can be controlled to make axial movement relative to the tube body 100 according to the actual situation of the target blood vessel, so as to at least adjust the stiffness of the distal end of the tube body assembly 10, so that the stiffness of the distal end of the tube body assembly 10 is appropriate, and then the distal end of the tube body assembly 10 has good pushing properties and flexibility. In this way, the distal end of the tube body assembly 10 can more easily pass through the tortuous and narrow target blood vessel.

[0051] The material coverage of the support layer 210 is set within a predetermined range. When the material coverage of the support layer 210 increases within the predetermined range, the stiffness of the pipe body assembly 10 decreases, and when the material coverage of the support layer 210 decreases within the predetermined range, the stiffness of the pipe body itself 10 increases.

[0052] It should be understood that the support layer 210 should be configured to be able to extend or shorten along the axial direction of the tube body 100, and the material coverage of at least a portion of the support layer 210 changes as the support layer 210 extends or shortens. Generally, when the support layer 210 extends along the axial direction of the tube body 100, the material coverage of at least a portion of the support layer 210 decreases, and when the support layer 210 shortens along the axial direction of the tube body 100, the material coverage of at least a portion of the support layer 210 increases. Since the distal end of the adjustment wire 220 is connected to the distal end of the support layer 210, when the adjustment wire 220 drives the distal end of the support layer 210 to move axially relative to the tube body 100, the change in the material coverage of the support layer 210 gradually decreases from the distal end to the proximal end. That is, once the distal end of the support layer 210 moves axially relative to the tube body 100 , the material coverage of the distal end of the support layer 210 will inevitably change, and the stiffness of the distal end of the tube body assembly 10 will inevitably change accordingly.

[0053] Generally, the support layer 210 is a tubular mesh structure woven from wires. Alternatively, the support layer 210 is a spring structure wound from wires. Alternatively, the support layer 210 includes both the tubular mesh structure and the spring structure, and the tubular mesh structure and the spring structure can be arranged in sequence in the axial direction of the tube body 100. In the embodiment of the present invention, the support layer 210 is preferably the tubular mesh structure, because the tubular mesh structure is an axisymmetric structure, and when the distal end of the support layer 210 is driven to move by the adjustment wire 220, the tubular mesh structure is not easy to twist, and in addition, the torque transmission performance of the tubular mesh structure is good. The spring structure is a non-axisymmetric structure, and when the distal end of the support layer 210 is driven to move by the adjustment wire 220, the spring structure may twist. It should be understood that the optional wires include metal wires such as stainless steel wire, nickel-titanium alloy wire, and tungsten wire, and may include polymer wires such as nylon wire. When the support layer 210 is made of metal wire, the material coverage is actually the metal coverage.

[0054] When the support layer 210 is the tubular mesh structure, the predetermined range is determined according to factors such as the material of the wire, the specification of the wire, the weaving method, the number of weaving strands, etc. When the support layer 210 is the spring structure, the predetermined range is determined according to the material, specification of the wire, and the number of strands during winding.

[0055] Generally, the tube body assembly 10 includes a proximal tube body 11 and a distal tube body 12, and the distal tube body 12 is connected to the distal end of the proximal tube body 11. The support layer 210 includes a first segment 211 and a second segment 212. The first segment 211 is disposed at the proximal tube body 11 and remains relatively stationary with the tube body 100. The second segment 212 is connected to the distal end of the first segment 211 and is disposed at the distal tube body 12. The second segment 212 can generate axial movement relative to the tube body 100, and the distal end of the second segment 212 constitutes the distal end of the support layer 210.

[0056] In other words, the distal end of the support layer 210 can generate axial movement relative to the tube body assembly 10 within the range of the distal tube body 12, but cannot generate axial movement relative to the tube body itself 10 within the range of the proximal tube body 11. That is, the stiffness of the distal tube body 12 of the tube body assembly 10 is adjustable, while the stiffness of the proximal tube body 11 is not adjustable. On the one hand, the reason for this arrangement is that when the distal part of the medical catheter can pass through a tortuous blood vessel, it indicates that the medical catheter can meet the use requirements. On the other hand, the distal end movement of the support layer 210 is driven by the adjusting wire 220, which actually transmits the driving force to the distal end of the support layer 210 through the adjusting wire 220, and the driving force is also transmitted to the support layer 210 along the axial direction of the tube body 100. In the case where only the second segment 212 can generate axial movement relative to the pipe body 100, the driving force is transmitted over a short distance on the support layer 210, with high transmission efficiency and not easy to deflect, so that the expansion and contraction of the second segment 212 can be well controlled, and the material coverage of the second segment 212 can be changed substantially uniformly in the circumferential direction. However, if the first segment 211 can also generate axial movement relative to the pipe body 100, the driving force can also be transmitted on the first segment 211, resulting in a too long transmission distance of the driving force, which can easily cause the direction of the driving force to change, and then cause the support layer 210 to twist, so that the material coverage of the support layer 210 cannot change uniformly in the circumferential direction.

[0057] Therefore, when the material coverage of the second segment 212 increases within a predetermined range, the stiffness of the distal tube body 12 of the tube body assembly 10 decreases, and when the material coverage of the second segment 212 decreases within a predetermined range, the stiffness of the distal tube body 12 of the tube body assembly 10 increases.

[0058] When the support layer 210 is the tubular mesh structure, and the material, specification, weaving method and number of weaving strands of the wire material are determined, the weaving density of the tubular mesh structure can be used to characterize the material coverage of the second segment 212. Thus, in a specific embodiment, the support layer 210 is a tubular mesh structure, and the wire material is a flat stainless steel wire with a size of 0.02mm*0.06mm (i.e., the width of the cross section of the stainless steel wire is 0.06mm and the height is 0.02mm), the weaving method is 1 on 1, and the number of weaving strands is 16, the predetermined range can be the material coverage corresponding to when the weaving density of the second segment 212 is 100PPI to 170PPI.

[0059] In addition, it can be understood that in the embodiment of the present invention, when the distal end of the support layer 210 is at the most distal end of the accommodating cavity, the length of the support layer 210 in the axial direction of the tube body 100 is the largest, and the second segment 212 of the support layer 210 has the smallest material coverage. When the distal end of the support layer 210 moves from the distal end to the proximal end, the length of the support layer 210 in the axial direction of the tube body 100 gradually decreases, and the material coverage of the second segment 212 gradually increases.

[0060] Further, the distal tube body 12 is bendable. The tube body assembly 10 is configured to control the bending of the distal tube body 12 by generating an axial relative movement of the adjustment wire 220 relative to the tube body 100. Specifically, the distal end surface of the support layer 210 is driven to rotate around a first rotation axis by generating an axial movement of the adjustment wire 220 relative to the tube body 100, thereby driving the distal tube body 12 to bend. The first rotation axis is perpendicular to the axial direction of the tube body 100.

[0061] To do this, refer to Figure 6 The regulating wire 220 includes a plurality of sub-regulating wires 221, which are arranged at intervals along the circumference of the tube body assembly 10, and the distal end of each sub-regulating wire 221 is connected to the distal end of the supporting layer 210. Optionally, the number of the sub-regulating wires 221 is four, and in other implementations, the number of the sub-regulating wires 221 may be less than or more than four, such as two, three, five, six, etc.

[0062] In this way, when all the sub-adjustment wires 221 synchronously move in the same direction in the axial direction of the tube body 100, for example, moving from the proximal end to the distal end, all the sub-adjustment wires 221 drive the distal end of the support layer 210 to move from the proximal end to the distal end, thereby reducing the material coverage rate on the second segment 212, or all the sub-adjustment wires 221 synchronously move from the distal end to the proximal end and drive the distal end of the support layer 210 to move from the distal end to the proximal end, thereby increasing the material coverage rate on the second segment 212. When a part of the sub-adjustment wires 221 move from the distal end to the proximal end, the adjustment wire 220 drives the distal end face of the support layer 210 to rotate around the first rotation axis, so that the distal tube body 12 bends. Specifically, when a part of the sub-regulating wire 221 is subjected to a pulling force pointing from the distal end to the proximal end, the part of the sub-regulating wire 221 moves from the distal end to the proximal end, and at the same time, the distal end of the support layer 210 corresponding to the part of the sub-regulating wire 221 moving in the direction from the distal end to the proximal end is subjected to a pulling force pointing from the distal end to the proximal end. Therefore, the distal end face of the support layer 210 rotates around the first rotation axis under the action of the pulling force pointing from the distal end to the proximal end, and pulls the distal tube body 12 to bend. In addition, another part of the sub-regulating wire 221 can be subjected to a pulling force pointing from the proximal end to the distal end due to the bending of the distal tube body 12, and moves from the proximal end to the distal end under the action of the pulling force pointing from the proximal end to the distal end.

[0063] In this way, when the medical catheter is used to perform intravascular treatment and control the distal tube body 12 to pass through a tortuous blood vessel, the stiffness of the distal tube body 12 can be adjusted by the adjustment wire 220, and then the distal tube body 12 can be controlled to bend by the adjustment wire 220 so that the distal tube body 12 can pass through the tortuous blood vessel.

[0064] In the embodiment of the present invention, all the sub-regulating wires 221 are located outside the supporting layer 210, that is, the regulating wires 220 are located between the supporting layer 210 and the outer tube 110. Also, the distal ends of all the sub-regulating wires 221 can be connected to the distal end of the supporting layer 210 in any suitable manner, for example, the distal ends of all the sub-regulating wires 221 are directly connected to the distal end of the supporting layer 210, or the distal ends of all the sub-regulating wires 221 are indirectly connected to the distal end of the supporting layer 210 through another component.

[0065] In an optional implementation, the tube body assembly 10 further includes a developing element 300, which is used to display the position of the tube body assembly 10 in the body and also used to display the bending state of the distal tube body 12. Specifically, the developing element 300 includes a first developing ring 310 and a second developing ring 320, both of which are arranged in the accommodating cavity and sleeved on the outer peripheral surface of the supporting layer 210. The first developing ring 310 is connected to the distal end of the supporting layer 210, and the second developing ring 320 is arranged at the junction of the first segment 211 and the second segment 212, and is preferably connected to the first segment 211.

[0066] In this case, the distal ends of all the sub-adjusting wires 221 may be connected to the first developing ring 310. Thus, the distal ends of the adjusting wires 220 are indirectly connected to the distal end of the supporting layer 210 through the first developing ring 310.

[0067] Furthermore, if Figures 4 to 7 As shown, the tube body assembly 10 also includes a limiter (not marked in the figure), which is arranged in the accommodating cavity and remains relatively still with the tube body 100. When the support layer 210 has a maximum length in the axial direction of the tube body 100, the distance between the limiter and the distal end of the support layer 210 is greater than zero, so as to avoid the limiter interfering with the movement of the distal end of the support layer 210. Preferably, the limiter 210 is arranged on the proximal tube body 11. The limiter is provided with a plurality of channels extending through the axial direction of the tube body 100, and the plurality of channels are arranged at intervals along the circumference of the tube body 100, and correspond one by one to the plurality of sub-adjustment wires 221. Each of the sub-adjustment wires 221 is partially passed through a corresponding one of the channels. This arrangement can guide each sub-adjustment wire 221 and limit the position of each sub-adjustment wire 221 in the circumferential direction of the tube body 100, thereby preventing the sub-adjustment wire 221 from being tangled and also avoiding entanglement between multiple sub-adjustment wires 221. In addition, when the sub-adjustment wire 221 is located outside the support layer 210, the stopper is also located outside the support layer 210.

[0068] In an optional implementation, the position-limiting member includes a plurality of position-limiting tubes 410, which are arranged at intervals along the circumference of the tube body 100 and correspond one-to-one to the plurality of sub-adjusting wires 221. The lumen of each position-limiting tube 410 constitutes one of the channels. That is, each sub-adjusting wire 221 is partially inserted into the lumen of the corresponding position-limiting tube 410.

[0069] Furthermore, the position limiting tube 410 can also be used to keep the first segment 211 of the support layer 210 relatively still with the tube body 100. In an optional implementation, the position limiting tube 410 is directly connected to the first segment 211. Since the circumferential position of the position limiting tube 410 on the tube body 100 is fixed and the axial length of the position limiting tube 410 is fixed, the first segment 211 can be kept relatively still with the tube body 100 under the restriction of the position limiting tube 410. In another implementation, the distal end of the position limiting tube 410 is connected to the second developing element 320, which can also achieve the purpose of keeping the first segment 211 relatively still with the tube body 100 by using the position limiting tube 410.

[0070] In addition, in the embodiment of the present invention, the material of the outer tube 110 can be a resin material with good ductility, such as nylon, Pebax (block polyether amide elastomer), etc. The material of the inner tube 120 has a low friction coefficient, and the optional materials are PTFE (polytetrafluoroethylene), PET (polyethylene terephthalate), FEP (perfluoroethylene propylene copolymer), etc.

[0071] For further information, please refer to Figure 2 Combined with Figure 8 and Fig. 9 The medical catheter further comprises a handle assembly 20, and the handle assembly 20 comprises a housing 500 and a driving mechanism 600. The housing 500 is sleeved on the outer peripheral surface of the proximal end of the tube body assembly 10 and is also connected to the tube body assembly 10. The driving mechanism 600 is partially disposed inside the housing 500 and is connected to the proximal end of the adjusting wire 220. The driving mechanism 600 is configured to drive the adjusting wire 220 to produce axial movement relative to the tube body 100.

[0072] Optionally, the housing 500 is provided with a plurality of through grooves 510, the number of which is equal to the number of the sub-adjustment wires 221. The plurality of through grooves 510 are arranged at intervals along the circumference of the tube body assembly 10, and correspond one-to-one to the plurality of sub-adjustment wires 221. Each through groove 510 extends along the axial direction of the tube body assembly 10. The drive mechanism 600 includes an annular structure, which is sleeved on the outer circumferential surface of the tube body assembly 10, and the inner diameter of the annular structure is large enough so that the annular structure can rotate around a second rotation axis, which is perpendicular to the axis of the tube body. A plurality of sub-driving parts 610 are formed on the annular structure, and the number of the sub-driving parts 610 is equal to the number of the through grooves 510. The plurality of sub-driving parts 610 are distributed at intervals along the circumference of the tube body assembly 10, and correspond one-to-one to the plurality of through grooves 510, that is, the plurality of sub-driving parts 610 correspond one-to-one to the plurality of sub-adjustment wires 221. Each of the sub-driving parts 610 passes through the corresponding through slot 510 and extends to the outside of the housing 500. The proximal end of each of the sub-adjusting wires 221 is connected to the corresponding sub-driving part 610.

[0073] When at least one of the sub-driving parts 610 is subjected to external force and drives the annular structure to make axial movement relative to the tube body 100, the driving mechanism 600 drives the adjusting wire 220 to make axial movement relative to the tube body 100, and then drives the distal end of the supporting layer 210 to make axial movement relative to the tube body 100, so as to change the material coverage of at least part of the second segment 212 or control the bending of the distal tube body 12.

[0074] Specifically, when the operator applies a force along the axial direction of the tube body assembly 10, for example, from the distal end to the proximal end, to all the sub-driving parts 610 at the same time, the annular structure moves as a whole in the direction from the distal end to the proximal end, and drives all the sub-adjustment wires 221 to move in the direction from the distal end to the proximal end, thereby driving the distal end of the support layer 210 to move in the direction from the distal end to the proximal end, thereby changing the material coverage of the second segment 212, thereby achieving the purpose of changing the stiffness.

[0075] One of the sub-drive parts 610 is called the first sub-drive part (not marked in the figure), and the sub-adjustment wire 221 connected to the first sub-drive part is called the first sub-adjustment wire (not marked in the figure). When the operator applies a pulling force from the distal end to the proximal end to the first sub-drive part, the first sub-drive part 610 moves from the distal end to the proximal end, and drives the first sub-adjustment wire to move from the distal end to the proximal end, and then drives the part of the support layer 210 connected to the first sub-adjustment wire to move from the distal end to the proximal end, so that the distal end face of the support layer 210 rotates around the first rotation axis, so that the distal tube body 12 is bent. At the same time, the movement of the first sub-drive part 610 also causes the annular structure to rotate around the second rotation axis. The other sub-adjustment wires 221 except the first sub-adjustment wire are subjected to a pulling force from the proximal end to the distal end as the annular structure rotates, and move from the proximal end to the distal end under the action of the pulling force from the proximal end to the distal end.

[0076] In some implementations, the annular structure is, for example, a circular ring, and a plurality of sliders may be provided on the circular arc, and each of the sliders may be used as a sub-driving unit (not shown in the figure). In other implementations, the annular structure is a regular polygon structure. The regular polygon structure includes a plurality of corners, i.e., the corners are formed at the junction of adjacent sides of the regular polygon, and each of the corners may be used as a sub-driving unit 610. Thus, when the number of the sub-adjusting wires 221 is four, the annular structure is in the positive direction.

[0077] Preferably, the driving mechanism 600 further includes a damping layer (not shown in the figure), which is arranged at least on the outer surface of the contact portion between the sub-driving part 610 and the housing 500, for example, on the entire outer surface of the sub-driving part 610, so that there is a certain damping between the contact portion between the driving mechanism 600 and the housing 500. In this way, the driving mechanism 600 can move axially relative to the tube body 100 only when the sub-driving part 610 is subjected to a large external force, thereby driving the adjusting wire 220 to move axially relative to the tube body 100. The damping layer can be made of natural rubber.

[0078] In addition, please refer to Figure 2 and Figure 4 , Figure 5 The medical catheter further comprises a Luer connector 700 and a guide head 800. The guide head 800 is connected to the distal end of the tube body assembly 10. The distal end of the Luer connector 700 is disposed in the housing 500 and is connected to the proximal end of the tube body assembly 10 (e.g., Fig.10 As shown in FIG. 5 , the proximal end of the Luer connector 700 extends to the outside of the housing 500.

[0079] Although the present invention is disclosed as above, it is not limited thereto. Those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A medical catheter, characterized in that: The invention comprises a tube body assembly, wherein the tube body assembly comprises: The tube body comprises an outer tube and an inner tube, wherein a receiving cavity is formed between the inner tube and the outer tube; The adjusting mechanism comprises a supporting layer and an adjusting wire; the supporting layer is sleeved on the outer circumferential surface of the inner tube, and the proximal end of the supporting layer remains relatively stationary with respect to the tube body; the adjusting wire extends along the axial direction of the tube body, and is at least partially arranged in the accommodating cavity, and the distal end of the adjusting wire is connected with the distal end of the supporting layer; the adjusting wire is configured to be able to generate axial movement relative to the tube body, and drive the distal end of the supporting layer to generate axial movement relative to the tube body, so as to at least change the material coverage of the distal end of the supporting layer.

2. The medical catheter according to claim 1, characterized in that: The support layer includes a woven tubular network structure; and / or the support layer includes a spring structure.

3. The medical catheter according to claim 1, characterized in that: The pipe body assembly is configured such that when the material coverage of the support layer increases within a predetermined range, the stiffness of the pipe body assembly decreases, and when the material coverage of the support layer decreases within the predetermined range, the stiffness of the pipe body assembly portion increases.

4. The medical catheter according to claim 1, characterized in that: The support layer includes a first segment and a second segment; the first segment remains relatively still with the tube body, and the material coverage of the first segment remains constant; the second segment is connected to the distal end of the first segment and can generate axial movement relative to the tube body.

5. The medical catheter according to claim 1, characterized in that: The regulating wire comprises a plurality of sub-regulating wires, the plurality of sub-regulating wires are arranged at intervals along the circumference of the tube body assembly, and the distal end of each sub-regulating wire is connected to the distal end of the supporting layer; When all the sub-adjustment wires move synchronously in the same direction along the axial direction of the tube body, the adjustment wire drives the distal end of the support layer to move axially relative to the tube body; when a part of the sub-adjustment wires move from the proximal end to the distal end, the adjustment wire drives the distal end face of the support layer to rotate around a rotation axis, and the rotation axis is perpendicular to the axis of the tube body.

6. The medical catheter according to claim 5, characterized in that The tube body assembly also includes a limit member, which is arranged in the accommodating cavity and remains relatively still with respect to the tube body; when the support layer has a maximum length in the axial direction of the tube body, the distance between the limit member and the distal end of the support layer is greater than zero; the limit member is provided with a plurality of channels extending through the axial direction of the tube body, and the plurality of channels are arranged at intervals along the circumference of the tube body and correspond one by one to the plurality of sub-adjusting wires; each of the sub-adjusting wires is partially passed through the corresponding channel.

7. The medical catheter according to claim 6, characterized in that The limiting member comprises a plurality of limiting tubes, which are arranged at intervals along the circumference of the tube body, and the lumen of each limiting tube constitutes one of the channels.

8. The medical catheter according to claim 5, characterized in that The medical catheter also includes a handle assembly, which includes a shell and a drive mechanism; the shell is connected to the proximal end of the tube body assembly; the drive mechanism is partially arranged inside the shell and connected to the proximal end of the adjustment wire, and the drive mechanism is configured to drive the adjustment wire to produce axial movement relative to the tube body.

9. The medical catheter according to claim 8, characterized in that The shell is provided with a plurality of through grooves, which are arranged at intervals along the circumference of the tube body assembly and correspond one-to-one to the plurality of sub-adjusting wires, and the through grooves extend along the axial direction of the tube body assembly; the driving mechanism comprises an annular structure, which is sleeved on the outer circumferential surface of the tube body assembly; a plurality of sub-driving parts are formed on the annular structure, which are distributed at intervals along the circumference of the tube body assembly and correspond one-to-one to the plurality of through grooves, and each sub-driving part extends from the corresponding through groove to the outside of the shell; the proximal end of each sub-adjusting wire is connected to a corresponding sub-driving part; The medical catheter is configured such that when at least one of the sub-driving parts is subjected to an external force and drives the annular structure to make an axial movement relative to the tube body, the driving mechanism drives the adjusting wire to make an axial movement relative to the tube body.

10. The medical catheter according to claim 9, characterized in that The annular structure is a regular polygon and includes a plurality of corners, and each of the corners constitutes a sub-driving portion.

11. The medical catheter according to claim 4, characterized in that: The tube body assembly also includes a developing element, which includes a first developing ring and a second developing ring. The first developing ring is connected to the distal end of the second segment, and the second developing ring is sleeved on the outer circumferential surface of the supporting layer and is located at the junction of the first segment and the second segment, and the second developing ring is connected to the first segment; the distal end of the adjusting wire is connected to the first developing ring.

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