Adjustably bending catheter assembly and medical instrument

Abstract

The present disclosure provides an adjustably bending catheter assembly and a medical instrument, and relates to the field of medical instruments. The adjustably bending catheter assembly comprises a sheath tube, a supporting piece, a lining tube, and a plurality of control wires. The sheath tube is provided with a bending section. The supporting piece is at least partially arranged on the bending section. The supporting piece extends in an extending direction of the sheath tube. The supporting piece is configured to at least enable a stretching modulus of the bending section to be greater than a bending modulus. The lining tube penetrates through the bending section. One end of the lining tube proximal to the bending section is connected to the bending section. The lining tube is provided with a plurality of notches which are spaced apart in an extending direction of the lining tube, and the notches are provided on the side of the lining tube proximal to the supporting piece. The plurality of control wires are connected to the lining tube. The plurality of control wires are configured to be capable of driving the lining tube and the bending section to be bent and deformed. According to the adjustably bending catheter assembly provided by the present disclosure, a woven mesh tube can be omitted, and compared with the outer diameter of a pilot bending part of an existing endoscope, the outer diameter of the adjustably bending catheter assembly is smaller.

Description

Adjustable curved catheter assembly and medical device

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This disclosure claims priority to Chinese patent application number 2024102643517, filed with the Chinese Patent Office on March 8, 2024, entitled “A Adjustable Bend Catheter Assembly and Medical Device,” the entire contents of which are incorporated by reference into this disclosure. Technical Field

[0003] The present disclosure relates to the field of medical equipment, and in particular to an adjustable bend catheter assembly and a medical device. Background Art

[0004] In existing endoscope solutions, the leading curved portion of the endoscope, which is inserted into the patient's body, is divided into four main layers, from the outside to the inside: an insulating layer, a barrier layer, a serpentine that controls the endoscope's curvature, and the contents. The serpentine is a multi-section, ring-shaped hinge with a large gap between adjacent sections, and its curvature is controlled by a cable.

[0005] There's a large gap between each two snake-bone rings. This gap is only nearly eliminated when the snake reaches its maximum bending angle. Therefore, before reaching the maximum bending angle, each hinge bends to varying degrees (due to inconsistent force arms, resistance arms, and friction). To avoid inconsistent curvature, or frequent high stress on the contents or ropes at certain locations, the snake is often wrapped with a braided mesh tube made of metal wire, which uses its own stiffness to average the bending of each hinge. Furthermore, to provide sealing and insulation between the inside and outside of the endoscope, an insulating layer made of a soft insulating material is placed outside the braided mesh tube. Consequently, the braided mesh tube and soft insulating layer cause the radial dimensions of the lead bend of the endoscope to be larger than normal.

[0006] Summary of the Invention

[0007] In view of this, the purpose of the present disclosure is to overcome the deficiencies in the prior art and provide an adjustable bend catheter assembly. By improving the inner liner and sheath tube, the braided mesh tube can be omitted, so that the outer diameter of the adjustable bend catheter assembly is smaller, the bending flexibility is higher, and the turning radius is smaller; and the adjustable bend catheter assembly can bend at a wider angle range and has better passability.

[0008] In addition, a medical device using the above-mentioned adjustable bend catheter assembly is provided.

[0009] The present disclosure provides the following technical solutions:

[0010] According to a first aspect of the present disclosure, there is provided an adjustable bend conduit assembly, the adjustable bend conduit assembly comprising:

[0011] a sheath tube having a curved section;

[0012] A support member, the support member being arranged at least at the curved section and extending along the extension direction of the sheath tube; wherein the support member is configured to at least enable the tensile modulus of the curved section to be greater than the flexural modulus;

[0013] An inner liner pipe, the inner liner pipe is passed through the curved section, and one end of the inner liner pipe close to the curved section is connected to the curved section; wherein the inner liner pipe has a plurality of notches, the plurality of notches are arranged at intervals along the extension direction of the inner liner pipe, and the notches extend along the circumference of the inner liner pipe; and the inner liner pipe has the notches on a side close to the support member;

[0014] A plurality of control wires are connected to the inner liner tube, and the plurality of control wires are configured to drive the inner liner tube and the bending section to bend and deform.

[0015] Optionally, the end of the notch is formed with a pointed end.

[0016] Optionally, the liner pipe is divided into a first pipe wall and a second pipe wall in its circumferential direction, wherein the notch is provided on the first pipe wall and the second pipe wall is provided as a planar structure.

[0017] Optionally, the support member is configured as a long strip structure;

[0018] The sheath tube has a first lumen extending along its extension direction, and the support member can be passed through and fixed in the first lumen.

[0019] Optionally, the first cavity is configured as a stepped channel, and a large diameter section of the first cavity is located in the curved section; wherein the support member is passed through and fixed to the large diameter section.

[0020] Optionally, the support member is embedded in the wall of the sheath tube, a gap is formed in the support member, and a side wall portion of the sheath tube is located in the gap, so that a van der Waals force is formed between the support member and the sheath tube.

[0021] Optionally, the sheath is made of insulating material.

[0022] Optionally, the support member includes at least one of carbon fiber wire, nickel titanium wire and steel wire rope.

[0023] Optionally, the thickness of the tube wall of the sheath tube is different, and the sheath tube further has a second lumen, the second lumen is extended along the extension direction of the sheath tube, and the second lumen is arranged in a thicker part of the tube wall of the sheath tube.

[0024] Optionally, the support member is located in a sector-shaped area with a central angle of 90° on the cross section of the sheath tube.

[0025] Optionally, the number of the control wire is one, and the control wire is configured to be elastically deformable and capable of transmitting thrust and tension; wherein, the control wire is connected to one end of the liner tube away from the curved section.

[0026] Optionally, there are two control wires, one of which is connected to one end of the liner tube away from the curved section, and the other is connected to the curved section.

[0027] Optionally, the liner tube and the sheath tube are clearance-fitted.

[0028] Optionally, the sheath tube has a third lumen, and the third lumen is extended along the extension direction of the sheath tube; wherein the control wire is passed through the third lumen.

[0029] According to a second aspect of the present disclosure, a medical device is provided, comprising the adjustable bend catheter assembly.

[0030] The embodiments of the present disclosure have the following advantages:

[0031] The adjustable bend catheter assembly provided by the present invention can be easily bent but difficult to stretch by implanting a support made of anisotropic material in the wall of the sheath. For a sheath reinforced by a support member on one side, the direction in which it cannot be deformed should be opposite to the direction in which the liner tube cannot be deformed on the interface, that is, the support member is located on the side of the sheath tube close to the notch on the liner tube; when the liner tube is compressed, the liner tube responds to the side where the notch is set by compression and bending, while the sheath tube is pulled at this time, the part without the support member undergoes tensile deformation, but the part with the support member does not undergo tensile deformation, and the sheath tube appears to bend on the side where the notch is set. When the liner tube is pulled, the liner tube responds to bend toward the side where the notch is set, while the sheath tube is compressed at this time, the part without the support member undergoes compressive deformation, but the part with the support member does not undergo compressive deformation, and the sheath tube appears to bend toward the side away from the notch. Obviously, the bending states and tendencies of the two are the same, allowing the bending capacity of the adjustable bend catheter assembly to be superimposed, thereby enhancing the bending capacity of the adjustable bend catheter assembly, increasing the bending range, reducing the turning radius, and improving maneuverability. In addition, by improving the inner liner and sheath tubes, so that both the inner liner and the sheath tube have a certain degree of elasticity and rigidity, the braided mesh tube can be eliminated, thereby reducing the outer diameter of the adjustable bend catheter assembly, improving its bending flexibility, and expanding the bending angle range.

[0032] In addition, the present disclosure also relates to a medical device. Since the above-mentioned adjustable bend catheter assembly has the above-mentioned technical effects, the medical device including the adjustable bend catheter assembly should have the same technical effects, which will not be repeated here.

[0033] In order to make the above-mentioned objectives, features and advantages of the present disclosure more obvious and easy to understand, preferred embodiments are given below and described in detail with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the following briefly introduces the drawings required for use in the embodiments. It should be understood that the following drawings only illustrate certain embodiments of the present disclosure and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without creative work.

[0035] FIG1 shows a schematic structural diagram of an adjustable bend conduit assembly provided in Embodiment 1 of the present disclosure;

[0036] FIG2 shows a schematic structural diagram of an adjustable bend conduit assembly provided in a second embodiment of the present disclosure;

[0037] FIG3 shows a schematic structural diagram of the inner liner provided in the first embodiment of the present disclosure from one perspective;

[0038] FIG4 shows a schematic structural diagram of the inner liner provided in the first embodiment of the present disclosure from another perspective;

[0039] FIG5 shows a schematic structural diagram of an inner liner pipe provided in a second embodiment of the present disclosure from one perspective;

[0040] FIG6 shows a schematic structural diagram of a sheath tube provided in the first embodiment of the present disclosure from one perspective;

[0041] FIG7 shows a schematic structural diagram of the sheath tube provided in the first embodiment of the present disclosure from another perspective;

[0042] FIG8 is a schematic structural diagram of a sheath tube provided in a second embodiment of the present disclosure from one perspective;

[0043] FIG9 is a schematic structural diagram of a sheath tube provided in a third embodiment of the present disclosure from one perspective;

[0044] FIG10 shows a schematic structural diagram of the sheath tube provided in the third embodiment of the present disclosure from another perspective;

[0045] FIG11 is a schematic diagram showing a partial structure of a notch of the liner pipe provided in the first embodiment of the present disclosure;

[0046] FIG12 shows a first state diagram of the liner pipe provided in the first embodiment of the present disclosure;

[0047] FIG13 shows a second state diagram of the liner pipe provided in the first embodiment of the present disclosure.

[0048] Explanation of the main component symbols: 100 - sheath; 110 - accommodating channel; 200 - support member; 210 - first cavity; 211 - large diameter section; 212 - small diameter section; 300 - liner tube; 310 - slot; 320 - first tube wall; 330 - second tube wall; 400 - control wire; 500 - content. DETAILED DESCRIPTION

[0049] The following describes in detail embodiments of the present disclosure, examples of which are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are intended only to explain the present disclosure and are not to be construed as limiting the present disclosure.

[0050] It should be noted that when an element is referred to as being "fixed to" another element, it may be directly on the other element or there may be an intermediate element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be an intermediate element. Conversely, when an element is referred to as being "directly on" another element, there is no intermediate element. The terms "vertical," "horizontal," "left," "right," and similar expressions used herein are for illustrative purposes only.

[0051] In this disclosure, unless otherwise expressly specified or limited, terms such as "mounted," "connected," "connect," and "fixed" should be understood broadly. For example, these terms may refer to fixed or detachable connections, or integration; mechanical or electrical connections; direct or indirect connections through an intermediate medium; and internal communication between two components or interaction between two components. Those skilled in the art will understand the specific meanings of these terms in this disclosure based on specific circumstances.

[0052] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. Throughout the present disclosure, "plurality" means two or more, unless otherwise specifically defined.

[0053] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one skilled in the art to which this application belongs. The terms used in the template description herein are for the purpose of describing specific embodiments only and are not intended to limit the present disclosure. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0054] Interventional medicine involves inserting specialized catheters or instruments into the lesion site for imaging, diagnosis, and treatment, guided by imaging modalities (X-ray, ultrasound, and CT). This approach, with its minimal invasiveness, few complications, and wide application (including cardiovascular and cerebrovascular diseases, peripheral vascular tumors, and non-vascular areas), has become the third most important clinical treatment.

[0055] Interventional catheters, such as microcatheters, guide catheters, catheter sheaths, angiography catheters, etc., are indispensable auxiliary or diagnostic tools in interventional surgery, which can assist other therapeutic devices or reagents to accurately reach the designated lesion location. Most interventional catheters on the market are adjustable bend catheters. The distal end of the sheath of the adjustable bend catheter is adjustable, and usually one or more pull wires are fixed to the distal end of the interventional catheter and extend all the way to the proximal end of the interventional catheter. The bending deformation of the interventional catheter can be controlled by the pull wire to increase its applicability. That is, when in use, the traction wire is pulled by the operating handle, so that the leading bend of the adjustable bend catheter connected to the traction wire is bent. This type of adjustable bend catheter has poor flexibility when bending, that is, the interventional catheter has the problems of poor bending flexibility of its leading bend, a small bending angle range, a large turning radius, and general passability.

[0056] In the endoscope solution, the leading curved portion of the endoscope that is inserted into the patient's body is divided into four main layers, from the outside to the inside: an insulating layer, a barrier layer, a snake that controls the bending of the endoscope, and the contents. The snake is a multi-section ring hinge with a large gap between adjacent sections, and its bending is controlled by a cable.

[0057] There's a large gap between each two snake-bone rings. This gap is only nearly eliminated when the snake reaches its maximum bending angle. Therefore, before reaching the maximum bending angle, each hinge bends to varying degrees (due to inconsistent force arms, resistance arms, and friction). To avoid inconsistent curvature, or frequent high stress on the contents or ropes at certain locations, the snake is often wrapped with a braided mesh tube made of metal wire, which uses its own stiffness to average the bending of each hinge. Furthermore, to provide sealing and insulation between the inside and outside of the endoscope, an insulating layer made of a soft insulating material is placed outside the braided mesh tube. Consequently, the braided mesh tube and soft insulating layer cause the radial dimensions of the lead bend of the endoscope to be larger than normal.

[0058] As shown in Figures 1, 3 and 6, in order to solve the above technical problems, according to the first aspect of the present disclosure, an adjustable bend catheter assembly is provided, which includes a sheath tube 100, a support member 200, an inner liner tube 300 and a plurality of control wires, the sheath tube 100 has a curved section; the support member 200 is at least partially arranged in the curved section, and the support member 200 is extended along the extension direction of the sheath tube 100; wherein the support member 200 is configured to: at least enable the tensile modulus of the curved section of the sheath tube 100 to be greater than the bending modulus; the inner liner tube 300 is passed through the curved section, and one end of the inner liner tube 300 close to the curved section is connected to the curved section; wherein the inner liner tube 300 has a plurality of notches 310, a plurality of notches 310 They are arranged at intervals along the extension direction of the liner tube 300, and the slots 310 are extended along the circumference of the liner tube 300; and the side of the liner tube 300 close to the support member 200 has a slot 310; a number of control wires 400 are connected to the liner tube 300, and the number of control wires 400 are configured to drive the liner tube 300 and the bending section to bend and deform.

[0059] The sheath 100 has a distal end and a proximal section. The distal end of the sheath 100 is the curved section, and the proximal section of the sheath 100 is the infusion section. The distal end of the sheath 100 is the end away from the endoscope operating handle and is the end that can be inserted into the human body first. The proximal end of the sheath 100 is connected to the endoscope operating handle. It should be noted that the sheath is not limited to the distal end for insertion into the human body. The infusion section can also be inserted into the human body. The portion of the sheath that is inserted into the human body is set according to needs.

[0060] In the present application, an inner liner tube 300 is provided within the curved section, and a plurality of notches 310 are provided on one side of the inner liner tube 300. The plurality of notches 310 are spaced apart along the extension direction (i.e., the axial direction) of the inner liner tube 300. The side of the inner liner tube 300 where the notches 310 are provided is close to the support member 200, that is, the notch 310 and the support member 200 are located on the same side of the sheath tube 100. Obviously, by providing the notches 310, the bending modulus of the inner liner tube 300 on the side where the notches 310 are provided can be reduced.

[0061] It should be noted that in the related art, when using an interventional catheter for examination, it is necessary to cooperate with the sheath to be inserted into the human body channel. However, in the scenario where the sheath is inserted into the human body, the sheath is mostly a soft tube, which is easily bent, stretched or compressed under the action of the part of the inner liner that is manipulated by the control wire to bend, and the forces acting on the inner liner and the sheath are mutually acting and reacting forces, that is, the bending of the inner liner driven by the control wire will cause the sheath to be stretched or compressed. The amount of deformation of the above-mentioned sheath being stretched or compressed will reduce the bending force of the inner liner, making the bending degree of the inner liner far lower than expected, and the bending effect is poor.

[0062] Therefore, by implanting an anisotropic support member 200, the present application can make the sheath 100 easy to bend but difficult to stretch in the direction in which the sheath 100 extends. When the distal curvature of the endoscope bends, the sheath 100 does not undergo stretching deformation due to the restraint of the support member 200. As a result, the bending state and direction of the two are the same, allowing the bending amount of the system composed of the endoscope and sheath 100 to be superimposed, thereby increasing the bending amount of the adjustable bend catheter assembly and improving the bending effect.

[0063] It is easy to understand that the sheath tube 100 is mostly a polymer-supported hose with elastic deformation capability. The sheath tube 100 has a receiving channel 110, and the inner liner tube 300 is inserted into the receiving channel 110. It should be noted that the support member 200 is not disposed in the receiving channel 110 to avoid compressing the space of the receiving channel 110 to accommodate the inner liner tube 300, and to provide a gap between the inner liner tube 300 and the receiving channel 110. This gap can reduce the bending resistance of the curved section of the inner liner tube 300. Since both the curved section and the sheath tube 100 are expected to undergo a large range of flexural deformation, the gap is provided to prevent them from getting stuck.

[0064] Optionally, the sheath tube 100 has a smaller surface friction coefficient, thereby reducing the frictional resistance between the curved section and the sheath tube 100, and further reducing the probability of a jam between the liner tube 300 and the sheath tube 100. For example, the sheath tube 100 is made of a material with a small friction coefficient.

[0065] Specifically, by disposing the support member 200 within the sheath tube 100 and because the support member 200 exhibits anisotropy, its configuration can achieve the characteristics of the support member 200 being easily bendable and difficult to stretch. Clearly, the sheath tube 100 equipped with the support member 200 is difficult to stretch or compress in its extension direction (i.e., axial direction), while the sheath tube 100 is easily bent in its radial direction. This is due to the difference between the tensile modulus of the support member 200 in the axial direction and the bending modulus in the radial direction of the sheath tube 100.

[0066] Obviously, since the tensile or compressive deformation of the sheath tube 100 is limited, the sheath tube 100 will not be stretched or compressed when the bending section is bent.

[0067] By using the adjustable bend catheter assembly provided by the present disclosure, a support member 200 made of anisotropic material is implanted in the wall of the sheath tube 100, so that the curved section of the sheath tube 100 can be easily bent but difficult to be stretched. For the sheath tube 100 reinforced by the support member 200 on one side, the direction in which it cannot be deformed should be opposite to the direction in which the liner tube 300 cannot be deformed on the interface, that is, the support member 200 is located on the side of the sheath tube 100 close to the notch 310 on the liner tube 300; when the liner tube 300 is compressed, the liner tube 300 responds to the compression and bends on the side where the notch 310 is set, while the sheath tube 100 is pulled, and the part without the support member 200 undergoes tensile deformation, but the part with the support member 200 does not undergo tensile deformation, and the sheath tube 100 appears to be bent on the side where the notch 310 is set. When the inner liner tube 300 is pulled, the inner liner tube 300 responds by bending toward the side where the notch 310 is not provided, while the sheath tube 100 is under pressure, and the portion of the sheath tube 100 where the support member 200 is not provided undergoes compression deformation, but the portion of the sheath tube 100 where the support member 200 is provided does not undergo compression deformation, and the sheath tube 100 appears to bend toward the side away from the notch 310. Obviously, the bending states and tendencies of the two are the same, so that the bending amount of the adjustable bend catheter assembly is superimposed, which can enhance the bending amount of the adjustable bend catheter assembly, increase the bending range, reduce the turning radius, and make the passability stronger. In addition, by improving the inner liner tube 300 and the sheath tube 100, the inner liner tube 300 and the sheath tube 100 both have a certain elasticity and rigidity, and the braided mesh tube can be omitted, so that the outer diameter of the adjustable bend catheter assembly is small, and its bending flexibility is higher, and the angle range that can be bent is larger.

[0068] As shown in FIG. 3 , based on the above embodiment, a tip is formed at the end of the notch 310 .

[0069] For example, the notch 310 extends along the circumference of the liner tube 300 but does not form a closed end, thereby forming two opposing ends. Providing a pointed end at the end of the notch 310 introduces concentrated stress, lowering the bending modulus of the notch 310. In other words, the pointed end can introduce stress concentration, making it easier for the liner tube 300 to bend at the notch 310, resulting in a longer lifespan.

[0070] Optionally, the slots 310 may have various shapes, and the various shapes may be arranged alternately. Optionally, the slots 310 may be triangular, rectangular with sharp corners, elongated, elongated with sharp corners, or a combination of rectangular and circular shapes. Of course, if the need for a pointed end of the slots 310 is not a consideration, the slots 310 may also be rectangular, for example.

[0071] As shown in Figures 4 and 5, based on the above embodiments, the liner pipe 300 is divided into a first pipe wall 320 and a second pipe wall 330 in its circumferential direction, wherein the notch 310 is set on the first pipe wall 320, the second pipe wall 330 is set to a plane structure, and the first pipe wall 320 is an arc structure.

[0072] For example, the basic cross-sectional shape of the liner pipe 300 can be circular, or it can be formed by the first pipe wall 320 and the second pipe wall 330. For example, the first pipe wall 320 is configured as an arc shape, and the second pipe wall 330 is configured as a planar structure, specifically a slat structure. This shape makes the curvature of the second pipe wall 330 of the liner pipe 300 much smaller than the curvature of the first pipe wall 320. This type of cross-section can transform the force-bearing unit of the liner pipe 300 from a shell shape to a plate shape when it bends, making it easier for it to undergo elastic bending and reducing stress concentration at a certain position on the liner pipe 300 caused by processing accuracy. It should be noted that the second pipe wall 330 is not cut by the notch 310. Obviously, the cross-sectional shape of the liner pipe 300 formed by the first pipe wall 320 and the second pipe wall 330 is D-shaped.

[0073] As shown in FIG8 , based on the above embodiment, the support member 200 is configured as a long strip structure; the sheath tube 100 has a first lumen 210 extending along its extension direction, and the support member 200 can be passed through and fixed in the first lumen 210 .

[0074] That is to say, the sheath 100 has a first lumen 210 and a receiving channel 110, the receiving channel 110 is configured to insert the inner liner 300, the inner liner 300 is configured to insert the contents 500 of surgical instruments such as endoscopes and cables, and the first lumen 210 is configured to install the support member 200. The present application can pre-set the first lumen 210 on the side wall of the sheath 100, and later fix the long strip of support member 200 in the first lumen 210. Among them, the fixing structure between the support member 200 and the sheath 100 can be unilaterally fixed, and of course it can also be set to bilaterally fixed. The fixing form is not specifically limited here, for example, it can also be fixed by gluing, or by interference fit.

[0075] For example, the first lumen 210 may be formed synchronously during the extrusion molding process of the sheath tube 100 , and the first lumen 210 may be expanded a second time as required later to meet the needs of installing the support member 200 .

[0076] As shown in FIG1 and FIG9 , based on the above embodiment, the first cavity 210 is configured as a stepped channel, and the large diameter section 211 of the first cavity 210 is located in the curved section; wherein the support member 200 is passed through and fixed to the large diameter section 211 .

[0077] The first lumen 210 is configured as a stepped channel, that is, the first lumen 210 has a large-diameter section 211 and a small-diameter section 212. Accordingly, the large-diameter section 211 and the small-diameter section 212 are disposed at opposite ends of the sheath tube 100. It should be noted that only the portion of the sheath tube 100 near the distal bend affects the bending effect of the distal bend. Therefore, it is sufficient to provide the support member 200 only in the large-diameter section 211. This eliminates the need for overall expansion of the first lumen 210, reduces processing effort, and can reduce the number of support members 200 used, thereby lowering costs.

[0078] In addition, since the small-diameter section 212 is not filled with the support member 200 , the small-diameter section 212 remains hollow, which can reduce the bending modulus of the sheath tube 100 , that is, can make the sheath tube 100 more easily bendable.

[0079] For example, the cross-section of the support member 200 can be set to be square, circular, oval, etc., which is not specifically limited here. Among them, the number of support members 200 can be multiple and arranged in parallel, or a single one can be selected, as long as it can meet the actual requirements.

[0080] It is easy to understand that if the design does not require the isotropic support member 200 to fill the entire sheath tube 100, the diameter of the first lumen 210 can be reduced in the design of the first lumen 210, and the first lumen 210 can be processed into a stepped shape through the expansion process. Similarly, the end face of the support member 200 made of anisotropic material is fixedly connected to the end face of the sheath tube 100. Optionally, the connection method between the end face of the support member 200 and the end face of the sheath tube 100 can refer to the above-mentioned methods such as gluing, which will not be repeated here.

[0081] As the liner tube 300 bends from being unbent, the required force gradually increases. That is, the force required to trigger the initial bending is relatively small. At this time, the unreinforced proximal end of the sheath tube 100 is sufficiently rigid to support the initial bending force. After the initial bending begins, the angle between the curved section of the sheath tube 100 and its interface changes. The support member 200, made of anisotropic material, receives radial force and acts on the inner wall of the sheath tube 100 to provide support. The provision of the support member 200 helps reduce the concentrated force at the interface between the curved section and the infusion section of the sheath tube 100, thereby increasing its lifespan.

[0082] As shown in Figure 6, based on the above embodiment, the support member 200 is embedded in the wall of the sheath tube 100, and a gap is formed in the support member 200. The side wall portion of the sheath tube 100 is located in the gap, so that a van der Waals force is formed between the support member 200 and the sheath tube 100.

[0083] The sheath 100 has a first lumen 210 extending therethrough, into which a support member 200 is embedded through a composite process, and the support member 200 is concentrated within the first lumen 210. The support member 200 exhibits anisotropy in overall performance, that is, it is difficult to be stretched axially but easily bent.

[0084] The support member 200 is directly carried by the sheath tube 100 during extrusion molding of the polymer. The gaps in the support member 200 are filled with the polymer fluid material. After extrusion, the support member 200 is cooled to form van der Waals force to fix the support member 200.

[0085] For example, the support member 200 is formed by a plurality of anisotropic strip materials arranged in parallel, and gaps are formed between the adjacent strip materials. When the tube is extruded, the polymer fluid material used to make the sheath tube 100 fills the gaps, thereby stably fixing the support member 200 in the sheath tube 100. In other words, the support member 200 is fixed to the sheath tube 100 by van der Waals forces.

[0086] On the basis of the above embodiment, the sheath tube 100 is made of insulating material.

[0087] In one embodiment, the sheath tube 100 may be a metal spring tube that is at least partially welded, so that it has higher structural support strength and elasticity.

[0088] Of course, when the medical device system using the sheath tube needs to be insulated from the outside, in other embodiments, the sheath tube 100 can be made of an insulating material; or, it can be made of the above-mentioned metal spring tube covered with an insulating sheath.

[0089] In other words, the sheath 100 is insulated to isolate the power source, and the medical device to which it is applied is an active medical device, such as an endoscope. Alternatively, the active medical device can be placed within the receiving channel 110 of the sheath 100 to achieve insulation. This approach eliminates the need for an additional outermost insulating tube for insulation, and this solution reduces the overall outer diameter of the active medical device, facilitating insertion of the active medical device into the human body.

[0090] Based on the above embodiment, the support member 200 includes at least one of carbon fiber wire, nickel titanium wire and steel wire rope.

[0091] For example, support member 200 is made of a strip of material having such properties, such as carbon fiber, nickel-titanium wire, or steel wire rope. Carbon fiber has a very low bending modulus, nickel-titanium wire exhibits pseudo-elasticity in the bending direction, and steel wire rope has a very low bending modulus and is relatively resistant to tensile deformation in the axial direction. It should be noted that the material is not limited to these materials and other materials that can achieve the same effect may also be used.

[0092] Optionally, the support member 200 is formed by a plurality of steel cables arranged in parallel. Similarly, the support member 200 can also be formed by a plurality of carbon fiber filaments or nickel-titanium filaments arranged in parallel. Alternatively, the support member 200 is formed by a mixture of a plurality of carbon fiber filaments, a plurality of nickel-titanium filaments, and a plurality of steel cables arranged in parallel.

[0093] As shown in FIG10 , based on the above embodiment, the thickness of the tube wall of the sheath tube 100 is different, and the sheath tube 100 further has a second lumen, which extends along the extension direction of the sheath tube 100 and is arranged in the thicker part of the tube wall of the sheath tube 100 .

[0094] For example, the first lumen 210, the second lumen, and the receiving channel 110 are arranged in parallel. By providing the second lumen in the wall of the sheath tube 100, the bending modulus of the sheath tube 100 can be further reduced, making the sheath tube 100 easier to bend and deform, and saving material. In particular, when the receiving channel 110 and the sheath tube 100 are not coaxial, the thickness of the sheath tube 100 wall will inevitably be uneven. Obviously, the bending modulus varies at different thicknesses of the wall. By providing the second lumen on the thicker side of the sheath tube 100 wall, the bending modulus of the thicker wall can be reduced, making it easier to bend.

[0095] As shown in FIG. 7 , based on the above embodiment, the accommodating channel 110 of the sheath tube 100 is coaxial with the sheath tube 100 ; wherein, the accommodating channel 110 is configured to accommodate the liner tube 300 .

[0096] The accommodating channel 110 is configured to allow the inner liner tube 300 to be inserted, and the inner liner tube 300 is configured to allow the contents to be inserted. The contents may be endoscopic foreign body forceps, cables, etc. Of course, the insertion end of an endoscope with a smaller outer diameter, such as an ultra-thin endoscope, may also be inserted. Obviously, the larger the inner diameter of the inner liner tube is, the more convenient it is for inspection and insertion of contents. It should be noted that the accommodating channel 110 and the sheath tube 100 are coaxial, which can ensure that the thickness of the tube wall of the sheath tube 100 is roughly the same at all locations, that is, the bending modulus of the sheath tube 100 at all locations is roughly equal, which is beneficial for the bending portion at the tip to drive the sheath tube 100 to bend.

[0097] It should be noted that the coaxiality of the accommodating channel 110 and the sheath tube 100 is ensured by extruding the support member 200 and the sheath tube 100 into an integrated arrangement. If the support member 200 is installed by subsequently expanding the hole to form the first lumen 210, it would be difficult to ensure the coaxiality of the accommodating channel 110 and the sheath tube 100 due to the subsequent expansion of the first lumen 210. Sufficient machining allowances must be reserved in the tube wall to prevent the machining of the first lumen 210 from affecting the accommodating channel 110.

[0098] As shown in FIG. 7 , based on the above embodiment, the support member 200 is located in a sector-shaped area with a central angle of 90° on the cross section of the sheath tube 100 .

[0099] In other words, it is not advisable to set the support member 200 on the cross section of the sheath tube 100 beyond the sector-shaped area with a central angle of 90° on the cross section of the sheath tube 100. If the support member 200 is set beyond the sector-shaped area with a central angle of 90° on the cross section of the sheath tube 100, for example, if the central angle of the support member 200 on the cross section of the sheath tube 100 is between 90° and 180°, the support member 200 will slightly affect the bending of the sheath tube 100; if the central angle of the support member 200 on the cross section of the sheath tube 100 is greater than 180°, the support member 200 will significantly affect the bending of the sheath tube 100 or even prevent the sheath tube 100 from bending.

[0100] Based on the above embodiment, the inner liner tube 300 is a thin tube with a through cut, which can be made of metal materials such as nickel-titanium or stainless steel, or a polymer material, and is shaped by laser cutting or electric spark cutting. In addition, the inner liner tube 300 should at least meet the following requirements: 1) the elastic modulus of the portion without the notch 310 is large, and basically no tensile deformation (<2%) will occur under the action of a force of ≤30N; 2) when the tube wall is thin enough, the bending modulus of the portion of the inner liner tube 300 where the notch 310 is provided is small, and a force of ≤30N can cause it to be completely bent until contact or near contact is made at the portion where the notch 310 is not provided. Among them, nickel-titanium material with pseudo-elasticity is the best. In cases where the number of cycles required is not very high (such as disposable endoscopes), stainless steel materials commonly used in medical devices can also be used. When the outer diameter is not extremely sensitive, polymer materials can also be used.

[0101] As shown in FIG1 , based on the above embodiment, the number of the control wire 400 is one, and the control wire 400 is configured to be able to transmit thrust and tension; wherein, the control wire 400 is connected to one end of the liner tube 300 away from the bending section.

[0102] For example, taking an endoscope as an example, the control wire 400 has a distal end and a proximal end. The distal end of the control wire 400 is connected to the end of the lining tube 300 away from the bending section and close to the side where the slot 310 is set. The proximal end of the control wire 400 is connected to the operating handle of the endoscope, and the control wire can undergo elastic deformation to adapt to the bending of the lining tube 300.

[0103] The control wire 400 itself should have a certain rigidity, or be made to have a certain rigidity in the axial direction through other restrictions, and it should be able to transmit both tension and thrust. For example, in an endoscope system, the curvature of the curved section is large, and the curvature of the curves at other positions is very small. Therefore, when the control wire 400 uses a material with relatively high rigidity, it will not affect the expected bending of the system. However, in some special use cases (ultra-fine systems, or when the non-active curved section of the endoscope is also inserted into a tortuous and narrow cavity), the control wire 400 is restricted by the system and can no longer use a material with relatively high rigidity or become thicker. Anisotropic materials such as nickel titanium can be used to reduce its bending modulus at the same axial rigidity; and by restricting its channel, it can have sufficient rigidity in the axial direction.

[0104] In this example, when the control wire 400 is subjected to tension, the liner tends to lengthen, thus bending upward. The sheath 100, which incorporates a support member made of anisotropic material, is subjected to compression. The anisotropic material cannot be compressed or stretched, and the non-reinforced side tends to shorten, thus bending upward. These two factors combine to cause the adjustable catheter assembly to bend upward. When the control wire 400 is subjected to a push, the adjustable catheter assembly bends downward.

[0105] As shown in FIG2 , based on the above embodiment, the number of the control wires 400 is two, one of the two control wires 400 is connected to the end of the liner tube 300 away from the curved section, and the other is connected to the curved section.

[0106] The biggest reason for limiting the thickness of the endoscope system is that there are too many contents 500 in the tip bending part that needs active bending, such as ropes and rope channels, and the distance between the hinges is relatively long, the maximum bending angle of each hinge is large, the curvature is uneven, or the discrete fitting line segments that constitute the overall curvature are too long. In order to avoid large scratches or additional parasitic friction, the overall filling rate of the tip bending part must be controlled to be relatively small.

[0107] The reasons why the curved part of a conventional endoscope is thicker are: the contents 500 themselves are larger and thicker + the braided mesh tube is thick + the insulating / sealed soft isolation outer skin is thick + the gap left by the rope channel / contents 500 scratching + the curvature inconsistency causing the contents 500 to be excessively bent and damaged or the damping to increase suddenly, etc.

[0108] In this application, since both control wires 400 transmit only tension, there are no specific requirements for their axial stiffness. They can be implemented using the most common thin steel wires, making the system more flexible and improving compliance. To more efficiently utilize space, the two control wires 400 can have rectangular cross-sections instead of circular ones, making the space more compact and allowing the endoscope system to be thinner.

[0109] Exemplarily, the slot 310 of the liner tube 300 and the support member 200 are located on the same side of the sheath tube 100, and the two control wires 400 are divided into a first control wire and a second control wire. The first control wire is connected to one end of the liner tube 300 away from the curved section of the sheath tube 100 and close to the slot 310, and the second control wire is connected to the side of the sheath tube 100 away from the support member 200.

[0110] When the first control wire is under tension, the inner lining tube 300 tends to become longer and therefore bends upward; the sheath tube 100 with the support member 200 is under pressure, and the support member 200 cannot be compressed / stretched. The side of the sheath tube 100 where the support member 200 is not provided tends to become shorter, so the sheath tube 100 bends upward. The combination of the two makes the adjustable bend catheter assembly bend upward.

[0111] When the second control wire is under tension, the sheath 100 with the support member 200 is under tension, the support member 200 cannot be compressed / stretched, and the side of the sheath 100 where the support member 200 is not provided tends to become longer, so the sheath 100 bends downward; the inner lining tube 300 is not directly subjected to force, but it is flexible in both bending directions in the plane, and bends along with the sheath 100. The two are combined to make the adjustable catheter assembly bend downward.

[0112] On the basis of the above embodiment, the liner tube 300 and the sheath tube 100 are clearance-fitted.

[0113] In other words, because both the liner tube 300 and the sheath tube 100 are expected to undergo a wide range of flexural deformation, the two tubes will bend (cross-sectional deformation) beyond flexure, so a gap is provided to prevent jamming. In addition, to further prevent jamming, the sheath tube 100 should be made of a material with a low elastic modulus to accommodate the deformation of the liner tube 300.

[0114] On the basis of the above embodiment, the sheath tube 100 has a third lumen, and the third lumen is extended along the extension direction of the sheath tube 100; wherein the control wire 400 is passed through the third lumen.

[0115] When there is only one control wire 400, the purpose of providing the third lumen is to limit the lumen of the control wire 400. When the control wire 400 is subjected to thrust at one end and resistance at the other end, its tendency to swing radially is forced to be restricted by the diameter of the third lumen and cannot be deformed, thereby better transmitting axial thrust. Of course, the purpose of designing the third lumen as a circular shape and its expanded shape is to reduce contact area and friction, improve transmission efficiency, and prevent the control wire from escaping to the sides of the third lumen due to size considerations, so that both thrust and tension can be applied.

[0116] In addition, by providing the third cavity, the manipulation wire 400 and the contents 500 in the accommodating channel 110 can be isolated, thereby reducing extrusion and wear.

[0117] As shown in Figures 11, 12 and 13, based on the above embodiments, each notch 310 of the liner tube 300 has different stiffness on both sides of a certain cross-section, and the stiffness difference is divided by a plane parallel to the axis and perpendicular to the cross-section of the liner tube 300. The radial stiffness on one side is equal to the inherent stiffness of the liner tube 300 without the notch 310, while the stiffness on the other side is weakened after the notch 310 is set. The stiffness dividing surface divides the parts in the figure into two parts P1 and P2. There is a stiffness difference E_(P_1)<E_(P_2) on both sides. When subjected to axial force, the P1 side is squeezed, and stress concentration and deformation occur relative to P2.

[0118] When the bending directions of the notches 310 are aligned, the liner 300 can bend as desired, as shown in Figure 12, where F is the driving force and F' is the restraining force. When the liner 300 is subjected to pressure, the notches 310 tend to be squeezed, causing the liner 300 to bend toward the notches 310.

[0119] Correspondingly, as shown in FIG. 13 , when the liner tube 300 is subjected to tension, the notch 310 tends to be stretched, and the liner tube 300 is bent toward the side away from the notch 310 .

[0120] Among them, when the stiffness dividing surfaces of each slot 310 interval are not parallel, the bending direction of the liner pipe 300 is the sum of the expected bending components of each section, and the pre-calculated bending shape can be achieved.

[0121] According to a second aspect of the present disclosure, a medical device is provided, comprising an adjustable bend catheter assembly.

[0122] Since the above-mentioned adjustable bend catheter assembly has the above-mentioned technical effects, the medical device including the adjustable bend catheter assembly should have the same technical effects, which will not be described in detail here.

[0123] For example, the medical device may be an endoscope mother endoscope, an endoscope endoscope, an endoscope foreign body forceps, etc. In this application, an endoscope foreign body forceps is taken as an example.

[0124] The endoscopic foreign body forceps has a handle for controlling the foreign body forceps, which drives the control wire 400 to move, thereby achieving control of the normal intended use of the instrument; the handle for controlling bending drives the control wire 400 to move, thereby achieving control of the bending of the instrument; the handle has a power terminal, through which the high-frequency electricity received by the system is transmitted and flows through to the head end of the foreign body forceps, wherein the sheath 100 made of polymer achieves insulation.

[0125] In all examples shown and described herein, any specific values ​​should be interpreted as merely exemplary and not limiting, and thus other examples of the exemplary embodiments may have different values.

[0126] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, it does not need to be further defined or explained in subsequent drawings.

[0127] The above-described embodiments merely represent several implementation methods of the present disclosure. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the present disclosure. It should be noted that a person skilled in the art would be able to make various modifications and improvements without departing from the scope of the present disclosure, all of which fall within the scope of protection of the present disclosure. Industrial Applicability

[0128] The adjustable bend catheter assembly and medical device provided by the present disclosure can make the sheath easy to bend but difficult to stretch by implanting a support made of anisotropic material in the wall of the sheath. For a sheath with a support reinforced on one side, the direction in which it cannot be deformed should be opposite to the direction in which the liner cannot be deformed on the interface, that is, the support is located on the side of the sheath close to the notch on the liner; when the liner is compressed, the liner responds to the side where the notch is set by compression and bending, while the sheath is pulled at this time, the part without the support undergoes tensile deformation, but the part with the support does not undergo tensile deformation, and the sheath appears to bend on the side where the notch is set. When the liner is pulled, the liner responds to bend toward the side where the notch is set, while the sheath is compressed at this time, the part without the support undergoes compressive deformation, but the part with the support does not undergo compressive deformation, and the sheath appears to bend toward the side away from the notch. Obviously, the bending states and tendencies of the two are the same, allowing the bending capacity of the adjustable bend catheter assembly to be superimposed, thereby enhancing the bending capacity of the adjustable bend catheter assembly, increasing the bending range, reducing the turning radius, and improving maneuverability. In addition, by improving the inner liner and sheath tubes, so that both the inner liner and the sheath tube have a certain degree of elasticity and rigidity, the braided mesh tube can be eliminated, thereby reducing the outer diameter of the adjustable bend catheter assembly, improving its bending flexibility, and expanding the bending angle range.

Claims

1. An adjustable bend catheter assembly, characterized in that: The adjustable bend conduit assembly comprises: a sheath tube having a curved section; a support member, the support member being at least partially disposed in the curved section and extending along the extension direction of the sheath; wherein the support member is configured to at least enable the tensile modulus of the curved section to be greater than the flexural modulus; An inner liner pipe, the inner liner pipe is passed through the curved section, and one end of the inner liner pipe close to the curved section is connected to the curved section; wherein the inner liner pipe has a plurality of notches, the plurality of notches are sequentially spaced along the extension direction of the inner liner pipe, and the notches extend along the circumference of the inner liner pipe, and the inner liner pipe has the notches on a side close to the support member; A plurality of control wires are connected to the inner liner tube, and the plurality of control wires are configured to drive the inner liner tube and the bending section to bend and deform.

2. The adjustable bend conduit assembly according to claim 1, characterized in that: An end of the notch is formed with a pointed end.

3. The adjustable bend conduit assembly according to claim 1 or 2, characterized in that: The inner liner pipe is divided into a first pipe wall and a second pipe wall in its circumferential direction; wherein the notch is set in the first pipe wall, and the second pipe wall is set as a planar structure.

4. The adjustable bend conduit assembly according to any one of claims 1 to 3, characterized in that: The support member is configured as a long strip structure; The sheath tube has a first lumen extending along its extension direction, and the support member is passed through and fixed in the first lumen.

5. The adjustable bend conduit assembly according to claim 4, characterized in that: The first cavity is configured as a stepped channel, and a large diameter section of the first cavity is located at the curved section; wherein the support member is passed through and fixed to the large diameter section.

6. The adjustable bend conduit assembly according to any one of claims 1 to 5, characterized in that: The support member is embedded in the wall of the sheath tube, and a gap is formed in the support member. The side wall of the sheath tube is located in the gap, so that a van der Waals force is formed between the support member and the sheath tube.

7. The adjustable bend conduit assembly according to any one of claims 1 to 6, characterized in that: The sheath tube is made of insulating material.

8. The adjustable bend conduit assembly according to any one of claims 4 to 7, characterized in that: The support member includes at least one of carbon fiber wire, nickel titanium wire and steel wire rope.

9. The adjustable bend conduit assembly according to any one of claims 4 to 8, characterized in that: The thickness of the tube wall of the sheath tube is different. The sheath tube further has a second lumen. The second lumen is extended along the extension direction of the sheath tube and is arranged at a thicker portion of the tube wall of the sheath tube.

10. The adjustable bend conduit assembly according to any one of claims 4 to 9, characterized in that: The support member is located in a sector-shaped area with a central angle of 90° on the cross section of the sheath tube.

11. The adjustable bend conduit assembly according to any one of claims 1 to 10, characterized in that: The number of the control wire is one, and the control wire is configured to be elastically deformable and capable of transmitting thrust and tension; wherein, the control wire is connected to one end of the liner tube away from the curved section.

12. The adjustable bend conduit assembly according to any one of claims 1 to 11, characterized in that: There are two control wires, one of which is connected to one end of the liner tube away from the curved section, and the other is connected to the curved section.

13. The adjustable bend conduit assembly according to claim 11 or 12, characterized in that: The sheath tube has a third lumen, and the third lumen is extended along the extension direction of the sheath tube; wherein the control wire is passed through the third lumen.

14. The adjustable bend conduit assembly according to any one of claims 1 to 13, characterized in that: The inner lining tube and the sheath tube are clearance-matched.

15. A medical device, characterized in that: The medical device comprises the adjustable bend catheter assembly according to any one of claims 1 to 14.

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