Medical catheter

Abstract

The application provides a medical catheter, which comprises a tube body assembly, the tube body assembly comprises a tube body and an adjusting mechanism, the tube body comprises an inner layer tube and an outer layer tube 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 is sleeved on the inner layer tube, and the proximal end of the supporting layer remains relatively stationary with the tube body; the adjusting wire extends along the axial direction of the tube body, and the distal end of the adjusting wire is connected with the distal end of the supporting layer; the adjusting wire can produce axial movement relative to the tube body, and drives the distal end of the supporting layer to produce axial movement relative to the tube body, so as to at least change the material coverage of the distal end of the supporting layer, and further at least change the rigidity of the distal end of the tube body assembly. The rigidity of the distal end of the medical catheter can be adjusted according to the actual situation of the blood vessel, so that the distal end of the medical catheter has good flexibility under the condition of meeting the pushing force, and can smoothly pass through the tortuous and narrow blood vessel.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and particularly relates to a medical catheter. BACKGROUND

[0002] A medical catheter is an important tool for intravascular treatment. Take a transhepatic arterial chemotherapy and embolization (TACE) as an example for introduction. The TACE is to inject embolic agents into the blood supply artery of a tumor through a medical catheter, so as to block the blood supply of the tumor, and then make the tumor ischemic and hypoxic, so as to inhibit the growth of the tumor and promote the necrosis and apoptosis of tumor cells.

[0003] When performing the TACE operation, the operator punctures the femoral artery, and then inserts a contrast catheter, and then performs DSA imaging to observe the tumor position and tumor blood supply vessel distribution. After the blood vessel path is determined, the catheter is superselected into the target artery of the tumor blood supply through the cooperation of the micro guide wire and the medical catheter, the micro guide wire is then 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 rigidity of the medical catheter should be appropriate, otherwise it is difficult 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, but if the distal end of the medical catheter is too soft, it has good flexibility, but it also has the problem of insufficient pushing force. That is, the rigidity of the medical catheter is an important factor for the smooth performance of the TACE operation. SUMMARY

[0005] The purpose of the present application is to provide a medical catheter, the rigidity of which can be adjusted, so that the rigidity can be adjusted according to actual needs during use, so that it can smoothly pass through the tortuous and narrow lesion site.

[0006] To achieve the above-mentioned purpose, the present application provides a medical catheter, which comprises a tube body assembly, the tube body assembly comprising:

[0007] a tube body, comprising an outer tube and an inner tube, a containing cavity being formed between the inner tube and the outer tube;

[0008] The adjusting mechanism comprises a support layer and an adjusting wire; the support layer is sleeved on the outer circumferential surface of the inner layer tube, the proximal end of the support layer is kept relatively stationary with 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, the distal end of the adjusting wire is connected with the distal end of the support layer, the adjusting wire is configured to generate axial movement relative to the tube body and drive the distal end of the support layer to generate axial movement relative to the tube body to at least change the material coverage of the distal end of the support layer.

[0009] Optionally, the support layer comprises a tube net structure woven together; and / or, the support layer comprises 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 rigidity of the tube body assembly decreases, and when the material coverage of the support layer decreases within the predetermined range, the rigidity of the tube body assembly part increases.

[0011] Optionally, the support layer comprises a first segment and a second segment; the first segment is kept relatively stationary 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.

[0012] Optionally, the adjusting wire comprises a plurality of sub-adjusting wires, the plurality of sub-adjusting wires are arranged in a circumferential direction of the tube body assembly, and the distal end of each sub-adjusting wire is connected with the distal end of the support layer.

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

[0014] Optionally, the tube body assembly further comprises a limiting piece arranged in the accommodating cavity and kept relatively stationary with the tube body; when the support layer has a maximum length in the axial direction of the tube body, the distance between the limiting piece and the distal end of the support layer is greater than zero; the limiting piece is provided with a plurality of channels extending through the axial direction of the tube body, the plurality of channels are arranged in a circumferential direction of the tube body and correspond to the plurality of sub-adjusting wires one by one; each sub-adjusting wire is partially arranged in the corresponding channel.

[0015] Optionally, the limiting member comprises a plurality of limiting tubes, the plurality of limiting tubes are arranged along the circumference of the tube body and correspond to the plurality of sub-adjusting wires one by one, and the lumen of each limiting tube constitutes one channel.

[0016] Optionally, the medical catheter further comprises a handle assembly, the handle assembly comprises a housing and a driving mechanism; the housing is connected to the proximal end of the tube body assembly; the driving mechanism is partially arranged in the interior of the housing and connected to the proximal end of the adjusting wire, and the driving mechanism is configured to drive the adjusting wire to produce axial movement relative to the tube body.

[0017] Optionally, a plurality of through grooves are arranged on the housing, the plurality of through grooves are arranged along the circumference of the tube body assembly and correspond to the plurality of sub-adjusting wires one by one, and the through grooves extend along the axial direction of the tube body assembly; the driving mechanism comprises an annular structure, the annular structure is arranged on the outer circumferential surface of the tube body assembly; a plurality of sub-driving portions are formed on the annular structure, the plurality of sub-driving portions are arranged along the circumference of the tube body assembly and correspond to the plurality of through grooves one by one, and each sub-driving portion extends from the corresponding through groove to the outside of the housing; the proximal end of each sub-adjusting wire is connected to the corresponding sub-driving portion.

[0018] The medical catheter is configured to drive the adjusting wire to produce axial movement relative to the tube body when at least one sub-driving portion is subjected to an external force and drives the annular structure to produce axial movement relative to the tube body.

[0019] Optionally, the annular structure is a regular polygon and comprises a plurality of corners, and each corner constitutes one sub-driving portion.

[0020] Optionally, the tube body assembly further comprises a developing element, the developing element comprises 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 arranged on the outer circumferential surface of the support layer and located at the joint 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 application has the following advantages:

[0022] The aforementioned medical catheter comprises a tube body assembly, which comprises a tube body and an adjusting mechanism, the tube body comprises an inner layer tube and an outer layer tube 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 support layer and an adjusting wire, the support layer is arranged in the containing cavity and is sleeved on the outer circumferential surface of the inner layer tube, the proximal end of the support layer is kept relatively stationary with the tube body; the adjusting wire extends along the axial direction of the tube body and is at least partially arranged in the containing cavity, the distal end of the adjusting wire is connected with the distal end of the support layer; the adjusting wire is configured to generate axial movement relative to the tube body and drive the distal end of the support 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 support layer, and in turn at least change the rigidity of the distal end of the tube body assembly. In this way, the rigidity of the distal end of the medical catheter can be adjusted as needed, so that it can have a rigidity suitable for the actual situation of the blood vessel, and has good flexibility while meeting the pushing force, thereby smoothly passing through the tortuous and narrow blood vessel. BRIEF DESCRIPTION OF DRAWINGS

[0023] The accompanying drawings are used to better understand the present application and do not constitute undue limitations on the present application. Among them:

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

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

[0026] Figure 3 is a schematic diagram of the cross section of the tube body assembly of the medical catheter provided by the present application according to an embodiment, and the adjusting wire is not shown in the diagram;

[0027] Figure 4 is a schematic diagram of the longitudinal section of the tube body assembly of the medical catheter provided by the present application according to an embodiment;

[0028] Figure 5 is a schematic diagram of the local structure of the tube body assembly of the medical catheter provided by the present application according to an embodiment;

[0029] Figure 6 is a schematic diagram of the local structure of the tube body assembly of the medical catheter provided by the present application according to an embodiment, and the tube body is not shown in the diagram;

[0030] Figure 7 is a schematic diagram of the local structure of the tube body assembly of the medical catheter provided by the present application according to an embodiment, and the tube body is not shown in the diagram, and Figure 7 the parts shown are different from Figure 6 .

[0031] Figure 8 Fig. 1 is a schematic diagram of a partial structure of a medical catheter according to an embodiment of the present application, mainly showing a handle assembly;

[0032] Figure 9 Fig. 2 is a schematic diagram of a partial structure of a medical catheter according to an embodiment of the present application, mainly showing a connection relationship between a driving part and an adjusting wire;

[0033] Figure 10 Fig. 3 is a schematic diagram of a partial structure of a medical catheter according to an embodiment of the present application, mainly showing a connection relationship between a tube body assembly and a luer joint.

[0034] [The following is a description of the reference numerals:]

[0035] 10-tube body assembly, 11-proximal tube body, 12-distal tube body, 100-tube body body, 110-outer tube, 120-inner tube, 200-adjusting mechanism, 210-support 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-housing, 510-through slot, 600-driving mechanism, 610-sub driving part, 700-luer joint, 800-guide head. DETAILED DESCRIPTION

[0036] The present application is described in greater detail by the following specific examples. Other advantages and benefits of the present application will become apparent to those skilled in the art upon reading the following description in conjunction with the accompanying drawings. The present application can be implemented or applied in other different specific embodiments, and each detail of the present application can be modified or changed based on different views and applications without departing from the spirit of the present application. It should be noted that the drawings provided in the present embodiment only schematically illustrate the basic concept of the present application, and thus only show the components related to the present application in the drawings, rather than being drawn according to the number, shape and size of the components in actual implementation. The type, number and proportion of the components in actual implementation can be arbitrarily changed, and the component layout type can be more complex.

[0037] In addition, each of the embodiments described below has one or more technical features, but this does not mean that all technical features in any embodiment must be implemented at the same time, or that only one or more technical features in different embodiments can be implemented separately. In other words, under the premise of being possible, those skilled in the art can selectively implement some or all of the technical features in any embodiment, or selectively implement a combination of some or all of the technical features in multiple embodiments, according to the disclosure of the present application, and according to the design specifications or implementation needs, thereby increasing the flexibility of the implementation of the present application.

[0038] As used in this specification, the singular forms "a," "an" and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense of "and / or" unless the content clearly dictates otherwise, and the terms "mounting," "connected," and "connection" should be construed broadly, for example, as fixedly connected, as detachably connected, or as integrally connected. 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 an internal connection of two elements or an interaction relationship between two elements. The relationship terms such as "first", "second", etc. are only used to separate one entity or operation from another entity or sub-drive, and do not necessarily require or imply any such actual relationship or order between the entities or operations, nor indicate or imply relative importance or implicitly indicate the number of indicated technical features. It should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "axial", "radial", "circumferential" and the like indicate the orientation or positional relationship shown in the drawings, and are only used for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0039] The terms "proximal" and "distal" herein are used to describe the relative position, relative orientation of various elements, components of a medical device, although non-limiting, "distal" is generally the end of the medical device that first enters the patient's body during use, and "proximal" is the end opposite to "distal".

[0040] The medical catheter in the prior art comprises a tube body assembly, which generally comprises an inner layer tube, a support layer and an outer layer tube arranged in sequence from inside to outside, wherein the support layer is a tube net structure woven by wire or a spring structure wound by wire. The material coverage of the support layer is an influencing factor of the rigidity of the tube body assembly. The inventors have found that when the material coverage of the support layer increases within a predetermined range, the rigidity of the tube body assembly decreases, and when the material coverage of the support layer decreases within the predetermined range, the rigidity of the tube body assembly increases. For the tube net structure, the predetermined range is related to the material and size of the wire, the weaving method and the number of weaving strands, and for the spring structure, the predetermined range is related to the material and size 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 to the entire outer circumferential surface of the support layer, which is equal to the area of the outer circumferential surface of the support layer minus the area of the gap portion.

[0041] When the support layer is the tube net structure and the material, size, weaving method and number of strands of the wire during weaving are determined, the material coverage of the support layer is actually determined by the weaving density of the tube net structure. In this paper, the number of weaving nodes per 1 inch length range in the axial direction of the support layer is taken as the weaving density, and the unit is PPI.

[0042] In practice, the inventors use stainless steel wire to weave the support layer to prepare the tube body assembly in the prior art. The stainless steel wire is a flat 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 1-1, and the number of weaving strands is 16. The inventors prepared three tube body assemblies with three different weaving densities of the support layer, which are numbered as No. 1 tube body assembly, No. 2 tube body assembly and No. 3 tube body assembly, wherein the weaving density of the support layer of No. 1 tube body assembly is 102PPI, the weaving density of the support layer of No. 2 tube body assembly is 127PPI, and the weaving density of the support layer of No. 3 tube body assembly is 169PPI. The rigidity 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 The maximum downward pressure in Table 2 represents the force required for the tube body assembly to produce the same degree of deformation, and the greater the maximum downward pressure, the greater the rigidity of the tube body assembly. From Table 2 and Figure 1It can be determined that, within the range of 100 PPI ~ 170 PPI (i.e. the number of braiding nodes in the range of 1 inch length in the axial direction of the support layer is 100 ~ 170), the greater the braiding density of the support layer, the smaller the maximum depression force of the tube body assembly, i.e. the smaller the stiffness of the tube body assembly. The smaller the stiffness 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 inventors propose a medical catheter, which comprises a tube body assembly, the tube body assembly comprising a tube body and an adjusting mechanism. The tube body comprises an outer tube and an inner tube arranged in the outer tube, and a containing cavity is formed between the inner tube and the outer tube. The adjusting mechanism comprises a support layer and an adjusting wire. The support layer is arranged in the containing cavity and is sleeved on the outer circumferential surface of the inner tube, and the proximal end of the support layer is kept relatively stationary with the tube body. The adjusting wire extends in the axial direction of the tube body and is partially arranged in the containing cavity. The distal end of the adjusting wire is connected with the distal end of the support layer. The adjusting wire is configured to be axially movable relative to the tube body to drive the distal end of the support layer to be axially movable relative to the tube body and to 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, the medical catheter can adjust the stiffness of the distal end of the tube body assembly according to the actual situation of the target blood vessel during use, so that the distal end of the tube body assembly has sufficient pushing force and good flexibility to smoothly pass through the target blood vessel.

[0048] To make the objects, advantages and features of the present application more clear, the following further describes the present application in detail in combination with the drawings. It should be noted that the drawings are all very simplified and use non-precise proportions, only for the purpose of conveniently and clearly assisting the description of the embodiments of the present application. The same or similar reference signs in the drawings represent the same or similar parts.

[0049] Figure 2 Fig. 1 shows a schematic view of the overall structure of a medical catheter provided by an embodiment of the present application. Please refer to Fig. 1, the medical catheter comprises a tube body assembly 10. Figure 2 Fig. 2 shows a sectional view of the tube body assembly 10, Figure 3 Fig. 3 shows a sectional view of the tube body assembly 10, Figures 4 to 6A partial structural schematic diagram of the tube body assembly 10 is shown below. Please refer to it. Figures 3 to 6 The tube body assembly 10 includes a tube body 100 and an adjustment mechanism 200. The tube body 100 includes an outer tube 110 and an inner tube 120 disposed inside the outer tube 110, with a receiving cavity formed between the outer circumferential surface of the inner tube 120 and the inner circumferential surface 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 circumferential surface of the inner tube 120, with its proximal end remaining relatively stationary to the tube body 100. The adjustment wire 220 extends axially along the tube 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 adjusting wire 220 is configured to move axially relative to the tube body 100 and drive the distal end of the support layer 210 to move axially relative to the tube body 100, thereby changing at least the material coverage of the distal end of the support layer 210 and thus at least changing the stiffness of the distal end of the tube assembly 10.

[0050] That is, when performing endovascular treatment using the medical catheter, the adjusting wire 220 can be controlled to move axially 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, thereby making the distal end of the tube body assembly 10 have both good pushability 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 tube assembly 10 decreases, and when the material coverage of the support layer 210 decreases within the predetermined range, the stiffness of the tube assembly 10 increases.

[0052] It should be understood that the support layer 210 should be configured to be able to elongate or shorten in the axial direction of the tube body 100, and the material coverage of at least a partial region of the support layer 210 changes with the elongation or shortening of the support layer 210. Generally, when the support layer 210 is elongated in the axial direction of the tube body 100, the material coverage of at least a partial region of the support layer 210 decreases, and when the support layer 210 is shortened in the axial direction of the tube body 100, the material coverage of at least a partial region 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 amount of 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 rigidity of the distal end of the tube body assembly 10 will inevitably change.

[0053] Generally, the support layer 210 is a tube net structure woven by wire. Alternatively, the support layer 210 is a spring structure wound by wire. Alternatively, the support layer 210 simultaneously includes the tube net structure and the spring structure, and the tube net 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 application, the support layer 210 is preferably the tube net structure, because the tube net structure is an axial symmetric structure, and when the distal end of the support layer 210 is driven to move by the adjustment wire 220, the tube net structure is not easy to twist, and in addition, the torque transmission performance of the tube net structure is better. The spring structure is a non-axial symmetric structure, and when the distal end of the support layer 210 is driven to move by the adjustment wire 220, the spring structure can twist. It should be understood that the optional wire includes metal wires such as stainless steel wire, nickel-titanium alloy wire, tungsten wire, and can include high molecular wire 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 tube net structure, the predetermined range is determined according to factors such as the material of the wire, the specification of the wire, the weaving method, and the weaving count. When the support layer 210 is the spring structure, the predetermined range is determined according to the material and specification of the wire, and the number of turns when winding.

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

[0056] In other words, the distal end of the support layer 210 is capable of axial movement with respect to the tube body assembly 10 within a range of the distal tube body 12, but is not capable of axial movement with respect to the tube body assembly 10 within a range of the proximal tube body 11. That is, the rigidity of the distal tube body 12 of the tube body assembly 10 is adjustable, but the rigidity of the proximal tube body 11 is not adjustable. One reason for this arrangement is that when the distal end portion of the medical catheter can pass through tortuous blood vessels, it indicates that the medical catheter can meet the use requirements. Another reason is that the movement of the distal end of the support layer 210 by the adjustment wire 220 is actually the transmission of driving force to the distal end of the support layer 210 by the adjustment wire 220, and the driving force is also transmitted along the axial direction of the tube body 100 on the support layer 210. In the case where only the second section 212 is capable of axial movement with respect to the tube body 100, the driving force is transmitted over a relatively short distance on the support layer 210, has high transmission efficiency, and is not easy to deflect, so that the extension and contraction of the second section 212 can be well controlled, and the material coverage of the second section 212 changes substantially uniformly in the circumferential direction. However, if the first section 211 is also capable of axial movement with respect to the tube body 100, the driving force can also be transmitted on the first section 211, resulting in a too long transmission distance of the driving force, which is easy to cause the direction of the driving force to change, and thus causes 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 section 212 increases within a predetermined range, the rigidity of the distal tube body 12 of the tube body assembly 10 decreases, and when the material coverage of the second section 212 decreases within a predetermined range, the rigidity of the distal tube body 12 of the tube body assembly 10 increases.

[0058] When the support layer 210 is the tube net structure, and the material of the wire, the specification of the wire, the weaving method and the weaving count are determined, the material coverage of the second section 212 can be characterized by the weaving density of the tube net structure. Thus, in one specific embodiment, the support layer 210 is the tube net structure, and the wire 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 1-1, and the weaving count is 16, the predetermined range can be the material coverage corresponding to the weaving density of 100 PPI-170 PPI of the second section 212.

[0059] In addition, it can be understood that, in the embodiment of the present application, when the distal end of the support layer 210 is at the distal end of the accommodating cavity, the length of the support layer 210 in the axial direction of the tube body 100 is the maximum, and the second section 212 of the support layer 210 has the minimum 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 section 212 gradually increases.

[0060] Further, the distal tube body 12 can be bent. The tube body assembly 10 is configured to control the bending of the distal tube body 12 by generating axial relative movement of the adjusting wire 220 relative to the tube body 100. Specifically, by generating axial movement of the adjusting wire 220 relative to the tube body 100 to drive the distal end face of the support layer 210 to rotate around a first rotation axis, thereby causing the distal tube body 12 to bend. The first rotation axis is perpendicular to the axial direction of the tube body 100.

[0061] To achieve this purpose, please refer to Figure 6 The adjusting wire 220 includes a plurality of sub-adjusting wires 221, and the plurality of sub-adjusting wires 221 are arranged in a circumferential direction of the tube body assembly 10, and the distal end of each sub-adjusting wire 221 is connected to the distal end of the support layer 210. Optionally, the number of sub-adjusting wires 221 is four, and in other implementations, the number of sub-adjusting wires 221 can be less than or more than four, for example, two, three, five, six, etc.

[0062] In this way, when all the sub-adjusting wires 221 move synchronously in the same direction in the axial direction of the tube body 100, for example, move from the proximal end to the distal end, all the sub-adjusting wires 221 drive the distal end of the support layer 210 to move from the proximal end to the distal end, thereby causing the material coverage on the second segment 212 to decrease, or all the sub-adjusting 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, so that the material coverage on the second segment 212 increases. When a part of the sub-adjusting wires 221 moves from the distal end to the proximal end, the adjusting 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-adjusting wires 221 is subjected to a pulling force from the distal end to the proximal end, this part of the sub-adjusting wires 221 moves from the distal end to the proximal end, and the distal end of the support layer 210 is subjected to a pulling force from the distal end to the proximal end corresponding to the part of the sub-adjusting wires 221 moving 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 from the distal end to the proximal end, and pulls the distal tube body 12 to bend. In addition, another part of the sub-adjusting wires 221 can be subjected to a pulling force 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 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 rigidity of the distal tube body 12 can be adjusted by the adjusting wire 220 first, and then the distal tube body 12 is controlled to bend by the adjusting wire 220, so that the distal tube body 12 passes through the tortuous blood vessel.

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

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

[0066] In this configuration, the distal ends of all the sub-adjustment wires 221 can be connected to the first developing ring 310. Thus, the distal ends of the adjustment wires 220 are indirectly connected to the distal ends of the support layer 210 via the first developing ring 310.

[0067] Furthermore, such as Figures 4 to 7 As shown, the tube body assembly 10 also includes a limiting member (not shown in the figure), which is disposed in the receiving cavity and remains relatively stationary with respect to the tube body 100. When the support layer 210 has its maximum length in the axial direction of the tube body 100, the distance between the limiting member and the distal end of the support layer 210 is greater than zero, so as to avoid the limiting member interfering with the movement of the distal end of the support layer 210. Preferably, the limiting member 210 is disposed on the proximal tube body 11. The limiting member has multiple channels extending through the axial direction of the tube body 100, and the multiple channels are arranged at intervals along the circumference of the tube body 100, corresponding one-to-one with multiple sub-adjusting wires 221. Each sub-adjusting wire 221 is partially inserted into a corresponding channel. This configuration guides each sub-adjusting wire 221 and restricts its circumferential position within the tube body 100, preventing kinking and entanglement. Furthermore, when the sub-adjusting wire 221 is located outside the support layer 210, the limiting member is also located outside the support layer 210.

[0068] In one optional implementation, the limiting member includes multiple limiting tubes 410, which are arranged at intervals along the circumference of the tube body 100 and correspond one-to-one with multiple sub-adjusting wires 221. The lumen of each limiting tube 410 forms a channel. That is, each sub-adjusting wire 221 partially passes through the lumen of the corresponding limiting tube 410.

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

[0070] In addition, in the embodiments of the present application, 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 material is PTFE (polytetrafluoroethylene), PET (polyethylene terephthalate), FEP (fluorinated ethylene propylene copolymer), etc.

[0071] Further, please refer to Figure 2 in combination with Figure 8 and Figure 9 , the medical catheter further comprises a handle assembly 20, the handle assembly 20 comprises a shell 500 and a driving mechanism 600. The shell 500 is sleeved on the outer circumferential surface of the proximal end of the tube body assembly 10, and is also connected with the tube body assembly 10. The driving mechanism 600 is partially arranged inside the shell 500, and is connected with 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 that of the sub-adjusting wires 221. The plurality of through grooves 510 are arranged along the circumference of the tube body assembly 10 and correspond to the plurality of sub-adjusting wires 221 one by one. Each of the through grooves 510 extends along the axial direction of the tube body assembly 10. The driving mechanism 600 comprises a ring structure, which is sleeved on the outer circumferential surface of the tube body assembly 10 and has an inner diameter large enough to allow the ring structure to rotate around a second rotation axis perpendicular to the axial direction of the tube body assembly 10. The ring structure is provided with a plurality of sub-driving portions 610, the number of which is equal to that of the through grooves 510. The plurality of sub-driving portions 610 are arranged along the circumference of the tube body assembly 10 and correspond to the plurality of through grooves 510 one by one, i.e., the plurality of sub-driving portions 610 correspond to the plurality of sub-adjusting wires 221 one by one. Each of the sub-driving portions 610 penetrates through the corresponding through groove 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 portion 610.

[0073] When at least one of the sub-driving portions 610 is subjected to an external force and drives the ring structure to move axially relative to the tube body 100, the driving mechanism 600 drives the adjusting wire 220 to move axially relative to the tube body 100, thereby driving the distal end of the support layer 210 to move axially relative to the tube body 100 to change the material coverage of at least part of the second section 212 or control the bending of the distal tube body 12.

[0074] Specifically, when the operator simultaneously applies an axial force along the tube body assembly 10, for example, a force directed from the distal end to the proximal end, to all of the sub-driving portions 610, the ring structure as a whole moves from the distal end to the proximal end and drives all of the sub-adjusting wires 221 to move from the distal end to the proximal end, thereby driving the distal end of the support layer 210 to move from the distal end to the proximal end to change the material coverage of the second section 212, thereby achieving the purpose of changing the rigidity.

[0075] One of the sub-driving parts 610 is called a first sub-driving part (not labeled in the figure), and the sub-adjusting wire 221 connected to the first sub-driving part is called a first sub-adjusting wire (not labeled in the figure). When a surgeon applies a pulling force to the first sub-driving part in a direction from the distal end to the proximal end, the first sub-driving part 610 moves in a direction from the distal end to the proximal end, and drives the first sub-adjusting wire to move in a direction from the distal end to the proximal end, and in turn drives the part of the support layer 210 connected to the first sub-adjusting wire to move in a direction from the distal end to the proximal end. In this way, 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-driving part 610 also causes the ring structure to rotate around the second rotation axis. The other sub-adjusting wires 221 except the first sub-adjusting wire are subjected to a pulling force in a direction from the proximal end to the distal end due to the rotation of the ring structure, and move in a direction from the proximal end to the distal end under the action of the pulling force in the direction from the proximal end to the distal end.

[0076] In some implementations, the ring structure is, for example, a circular ring, and a plurality of sliders can be arranged on the circular arc, and each of the sliders is taken as a sub-driving part (not shown in the figure). In other implementations, the ring structure is a regular polygon structure. The regular polygon structure includes a plurality of corners, i.e., the corners are formed at the junctions of adjacent sides of the regular polygon, and each of the corners can be taken as a sub-driving part 610. In this way, when the number of sub-adjusting wires 221 is four, the ring structure is a regular polygon.

[0077] As a preference, the driving mechanism 600 further includes a damping layer (not shown in the figure), which is arranged on at least the outer surface of the contact part between the sub-driving part 610 and the shell 500, for example, on the entire outer surface of the sub-driving part 610, so that there is a certain damping between the contact part between the driving mechanism 600 and the shell 500. In this way, the driving mechanism 600 can only move axially relative to the tube body 100 when the sub-driving part 610 is subjected to a relatively large external force, and in turn drives 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 includes a luer joint 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 joint 700 is arranged in the shell 500, and is connected to the proximal end of the tube body assembly 10 (as shown in Figure 10 ), and the proximal end of the luer joint 700 extends to the outside of the shell 500.

[0079] While the application has been disclosed in connection with the preferred embodiments thereof, it will be apparent to those skilled in the art that modifications and variations can be made thereto which fall within the spirit and scope of the application. Thus, it is intended that the application covers all modifications and variations of this application that come within the scope of the appended claims and their equivalents.

Claims

1. A medical catheter, characterized in that, Includes a tube body assembly, the tube body assembly comprising: The tube body includes an outer tube and an inner tube, with a receiving cavity formed between the inner tube and the outer tube; An adjustment mechanism includes a support layer and an adjustment wire; the support layer is 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; the adjustment wire extends axially along the tube body and is at least partially disposed 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 capable of axial movement relative to the tube body and to drive the distal end of the support layer to axially move relative to the tube body, so as to at least change the material coverage of the distal end of the support layer; 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 is capable of axial movement relative to the tube body, and the distal end of the second segment constitutes the distal end of the support layer. The tube assembly is configured such that when the material coverage of the support layer increases within a predetermined range, the stiffness of the tube assembly decreases, and when the material coverage of the support layer decreases within the predetermined range, the stiffness of a portion of the tube assembly increases. The adjusting wire includes multiple sub-adjusting wires, which are arranged circumferentially around the tube body assembly, and the distal end of each sub-adjusting wire is connected to the distal end of the support layer. When all the sub-adjusting wires move synchronously in the same direction along the axial direction of the tube body, the adjusting wires drive the distal end of the support layer to move axially relative to the tube body. When a portion of the sub-adjusting wires move from the proximal end to the distal end, the adjusting wires drive the distal end face of the support layer to rotate about a rotation axis perpendicular to the axis of the tube body.

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

3. The medical catheter according to claim 1, characterized in that, The tube assembly further includes a limiting member disposed in the receiving cavity and remaining relatively stationary with respect to the tube body. When the support layer has its maximum length in the axial direction of the tube body, the distance between the limiting member and the distal end of the support layer is greater than zero. The limiting member is provided with multiple channels extending through the axial direction of the tube body. The multiple channels are arranged at intervals along the circumference of the tube body and correspond one-to-one with multiple sub-adjusting wires. Each sub-adjusting wire is partially inserted into the corresponding channel.

4. The medical catheter according to claim 3, characterized in that, The limiting component includes multiple limiting tubes, which are arranged at intervals along the circumference of the tube body, and the lumen of each limiting tube forms a channel.

5. The medical catheter according to claim 1, characterized in that, The medical catheter also includes a handle assembly comprising a housing and a drive mechanism; the housing is connected to the proximal end of the tube body assembly; the drive mechanism is partially disposed inside the housing and connected to the proximal end of the adjustment wire, the drive mechanism being configured to drive the adjustment wire to move axially relative to the tube body.

6. The medical catheter according to claim 5, characterized in that, The housing is provided with a plurality of through slots, which are arranged at intervals along the circumference of the tube assembly and correspond one-to-one with a plurality of sub-adjusting wires. The through slots extend along the axial direction of the tube assembly. The driving mechanism includes an annular structure, which is sleeved on the outer circumferential surface of the tube assembly. A plurality of sub-driving parts are formed on the annular structure, which are distributed at intervals along the circumference of the tube assembly and correspond one-to-one with a plurality of through slots. Each sub-driving part extends from the corresponding through slot to the outside of the housing. 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-drive units is subjected to an external force and causes the annular structure to move axially relative to the catheter body, the drive mechanism drives the adjusting wire to move axially relative to the catheter body.

7. The medical catheter according to claim 6, characterized in that, The ring structure is a regular polygon and includes multiple corners, each of which constitutes a sub-drive unit.

8. The medical catheter according to claim 1, characterized in that, The tube assembly further 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 peripheral surface of the support layer and 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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