CN117838019A

CN117838019A - Adjustable curved pipe assembly and medical instrument

Info

Publication number: CN117838019A
Application number: CN202410264351.7A
Authority: CN
Inventors: 徐科端; 谢天灵
Original assignee: Shenzhen Kesimingde Medical Technology Co ltd
Current assignee: Shenzhen Kesimingde Medical Technology Co ltd
Priority date: 2024-03-08
Filing date: 2024-03-08
Publication date: 2024-04-09
Anticipated expiration: 2044-03-08
Also published as: CN117838019B

Abstract

The invention provides an adjustable bent catheter assembly and a medical instrument, and relates to the field of medical instruments. The adjustable bending catheter assembly comprises a sheath tube, a supporting piece, an inner liner tube and a plurality of control wires, wherein the sheath tube is provided with a bending section; the support piece is at least partially arranged on the bending section and extends along the extending direction of the sheath tube; the support is configured to at least enable the bending section to have a tensile modulus greater than the bending modulus; the lining pipe penetrates through the bending section, and one end of the lining pipe, which is close to the bending section, is connected with the bending section; the lining pipe is provided with a plurality of notches which are arranged at intervals along the extending direction of the lining pipe; the side of the lining pipe, which is close to the supporting piece, is provided with a notch; a plurality of steering wires are connected with the liner tube, the plurality of steering wires being configured to drive bending deformation of the liner tube and the curved section. The adjustable bending catheter assembly provided by the invention can omit a braided mesh tube, and has smaller outer diameter compared with the outer diameter of the guide bending part of the traditional endoscope.

Description

Adjustable curved pipe assembly and medical instrument

Technical Field

The invention relates to the field of medical equipment, in particular to an adjustable bent catheter assembly and a medical instrument.

Background

In the conventional endoscope scheme, the portion of the endoscope where the pilot bending portion is inserted into the patient is mainly divided into 4 layers, and is divided into: insulating layer, isolation layer, control endoscope crooked snake bone, content. Wherein, the snake bone is a mechanism formed by a plurality of sections of annular hinges, a large gap is reserved between every two adjacent sections, and the bending of the snake bone is controlled by ropes.

The gap between every two sections of snake bone rings is quite large, and when the snake bone reaches the actual maximum bending angle, the gap can be nearly eliminated, so that when the maximum bending angle is not reached, the bending degree of each hinge is different (the force arm, the resistance arm, the friction force are inconsistent and the like), in order to avoid the conditions of inconsistent curvature, frequent high stress of contents or ropes at certain positions and the like, the snake bone is externally enveloped with a layer of metal wire to form a woven mesh tube, and the woven mesh tube is bent to each hinge by utilizing a self-rigidity average system. In addition, in order to seal and insulate the inside/outside of the endoscope, an insulating layer made of soft insulating material is further provided outside the braided mesh tube. Thus, the braided mesh tube and the soft insulating layer cause the radial dimension of the leading bending portion of the endoscope to become large.

Disclosure of Invention

Accordingly, the present invention is directed to overcoming the shortcomings of the prior art, and providing an adjustable bend catheter assembly, which can omit a braided mesh tube by improving a lining tube and a sheath tube, so that the outer diameter dimension of the adjustable bend catheter assembly is smaller, the flexibility of bending is higher, and the turning radius is smaller; and, the angle range that the adjustable curved conduit assembly can bend is larger, the trafficability characteristic is stronger;

in addition, a medical apparatus using the adjustable bend catheter assembly is provided.

The invention provides the following technical scheme:

according to a first aspect of the present disclosure, there is provided an adjustable bend conduit assembly comprising:

a sheath having a curved section;

the support piece is at least arranged on the bending section and extends along the extending direction of the sheath tube; wherein the support is configured to at least enable a tensile modulus of the curved section to be greater than a flexural modulus;

the lining pipe penetrates through the bending section, and one end, close to the bending section, of the lining pipe is connected with the bending section; the lining pipe is provided with a plurality of notches, the notches are arranged at intervals along the extending direction of the lining pipe, and the notches extend along the circumferential direction of the lining pipe; and the side of the lining pipe, which is close to the supporting piece, is provided with the notch;

The lining pipe comprises a lining pipe body, a plurality of control wires, a plurality of lining pipes and a plurality of bending sections, wherein the lining pipes are connected with the lining pipe body through the lining pipes, the lining pipes are arranged on the lining pipes, the bending sections are connected with the lining pipes, and the lining pipes are connected with the lining pipes through the lining pipes.

Further, the notch is formed with a tip at an end thereof.

Further, the lining pipe is divided into a first pipe wall and a second pipe wall in the circumferential direction, wherein the notch is formed in the first pipe wall, and the second pipe wall is in a planar structure.

Further, the support member is provided in a long strip-like structure;

the sheath tube is provided with a first cavity channel extending along the extending direction of the sheath tube, and the supporting piece can be fixed in the first cavity channel in a penetrating mode.

Further, the first cavity channel is arranged as a stepped pore channel, and the large-diameter section of the first cavity channel is positioned at the bending section; wherein the supporting piece is fixedly arranged on the large-diameter section in a penetrating way.

Further, the support is embedded in the wall of the sheath, the support is formed with a gap, and the side wall portion of the sheath is located in the gap, so that van der Waals force is formed between the support and the sheath.

Further, the sheath is made of an insulating material.

Further, the support member includes at least one of carbon fiber wires, nickel titanium wires and steel wire ropes.

Further, the thickness of the tube wall of the sheath tube is different, the sheath tube is further provided with a second cavity, the second cavity extends along the extending direction of the sheath tube, and the second cavity is arranged at the thicker part of the tube wall of the sheath tube.

Further, the support member is located in a sector area with a central angle of 90 ° on the cross section of the sheath tube.

Further, the number of the control wires is one, and the control wires are configured to be elastically deformable and to be capable of transmitting pushing force and pulling force; wherein, control the silk connect in the inside lining pipe is kept away from the one end of bending section.

Further, the number of the control wires is two, one of the two control wires is connected with one end of the lining pipe far away from the bending section, and the other control wire is connected with the bending section.

Further, the inner liner tube and the sheath tube are in clearance fit.

Further, the sheath tube is provided with a third cavity, and the third cavity is arranged in an extending mode along the extending direction of the sheath tube; wherein, control the silk and wear to locate the third chamber way.

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

Embodiments of the present invention have the following advantages:

by adopting the adjustable bending catheter assembly provided by the invention, the support piece made of the anisotropic material is implanted into the wall of the sheath, so that the sheath can be easily bent but is difficult to stretch. For the sheath tube with the reinforced supporting piece arranged on one side, the non-deformable direction of the sheath tube is opposite to the non-deformable direction of the lining tube on the interface, namely the supporting piece is positioned on one side of the sheath tube close to the notch on the lining tube; when the lining pipe is pressed, the lining pipe is compressed and bent in response to the side provided with the notch, and at the moment, the sheath pipe is pulled, the part not provided with the supporting piece is stretched and deformed, but the part provided with the supporting piece is not stretched and deformed, and the sheath pipe is bent on the side provided with the notch. When the liner tube is pulled, the liner tube is bent in response to the side thereof not provided with the notch, and at this time, the sheath tube is pressed, the portion of the sheath tube not provided with the support is compressively deformed, but the portion of the sheath tube provided with the support is not compressively deformed, and the sheath tube appears to be bent toward the side away from the notch. Obviously, the bending states and trends of the two are the same, so that the bending amount of the adjustable bending catheter assembly is overlapped, the bending amount of the adjustable bending catheter assembly can be enhanced, the bending range is enlarged, the turning radius is reduced, and the trafficability is stronger. In addition, by modifying the inner liner tube and the sheath tube, the inner liner tube and the sheath tube have certain elasticity and rigidity, and the braided net-shaped tube can be omitted, so that the outer diameter size of the adjustable bending catheter assembly is smaller, the bending flexibility is higher, and the bending angle range is larger.

In addition, the present invention also relates to a medical apparatus, and since the above-mentioned bendable catheter assembly has the above-mentioned technical effects, the medical apparatus including the bendable catheter assembly should have the same technical effects, and will not be described herein.

In order to make the above objects, features and advantages of the present invention more comprehensible, preferred embodiments accompanied with figures are described in detail below.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed in the embodiments will be briefly described below, it being understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and other related drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic view of an adjustable bend catheter assembly according to a first embodiment of the present invention;

FIG. 2 is a schematic view of a second embodiment of the present invention;

FIG. 3 is a schematic view showing a view of a liner pipe according to an embodiment of the present invention;

FIG. 4 is a schematic view showing another view of a liner pipe according to an embodiment of the present invention;

FIG. 5 is a schematic view showing a structure of a liner tube according to a second embodiment of the present invention;

FIG. 6 is a schematic view showing a structure of a sheath tube according to an embodiment of the present invention;

FIG. 7 is a schematic view showing another view of a sheath according to the first embodiment of the present invention;

FIG. 8 is a schematic view showing a structure of a sheath according to a second embodiment of the present invention;

FIG. 9 is a schematic view showing a structure of a sheath tube according to a third embodiment of the present invention;

FIG. 10 is a schematic view showing another view of a sheath tube according to a third embodiment of the present invention;

FIG. 11 is a schematic view showing a partial structure at a notch of a liner pipe according to an embodiment of the present invention;

FIG. 12 illustrates a first state diagram for a liner provided in accordance with an embodiment of the present invention;

fig. 13 shows a second state diagram of the liner tube provided by the first embodiment of the invention.

Description of main reference numerals:

100-sheath tube; 110-accommodating channels; 200-supporting pieces; 210-a first lane; 211-large diameter section; 212—small diameter section; 300-lining tube; 310-notch; 320—a first tube wall; 330-a second tube wall; 400-controlling the wire; 500-content.

Detailed Description

Embodiments of the present invention are described in detail below, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to like or similar elements or elements having like or similar functions throughout. The embodiments described below by referring to the drawings are illustrative only and are not to be construed as limiting the invention.

It will be understood that when an element is referred to as being "fixed to" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. In contrast, when an element is referred to as being "directly on" another element, there are no intervening elements present. The terms "vertical," "horizontal," "left," "right," and the like are used herein for illustrative purposes only.

In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, as for example: the two parts can be fixedly connected, detachably connected or integrated; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.

Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the present invention, the meaning of "a plurality" is two or more, unless explicitly defined otherwise.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the templates herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.

In the related art, interventional medicine is to insert a special catheter or instrument into a lesion site for radiography, diagnosis and treatment through a percutaneous puncture path or through an original duct of a human body under the guidance of image medicine (X-ray, ultrasound and CT). The method has the advantages of small trauma, less complications and wide application range (can be applied to the fields of cardiovascular and cerebrovascular diseases, peripheral vascular tumors, non-vascular fields and the like) and becomes the third largest clinical treatment means.

Interventional catheters, such as microcatheters, guide catheters, catheter sheaths, contrast catheters, and the like, are indispensable auxiliary or diagnostic tools in interventional procedures that assist other therapeutic instruments or agents in precisely reaching a designated lesion site. The interventional catheters in the market are mostly adjustable curved catheters, a sheath tube at the distal end of the adjustable curved catheter is adjustable in curve, one or more stay wires are usually fixed at the distal end of the interventional catheter and extend to the proximal end of the interventional catheter, and further the bending deformation of the interventional catheter can be controlled through the stay wires, so that the applicability of the interventional catheter is improved. That is, when in use, the traction wire is pulled by the operation handle, so that the guide bending part of the adjustable bending catheter connected with the traction wire is bent. The bending-adjustable catheter has poor flexibility in bending, that is, the guiding bending part of the interventional catheter has poor bending flexibility, small bending angle range, large turning radius and general trafficability.

In addition, in the endoscope embodiment, the portion of the endoscope where the pilot bending portion is inserted into the patient is mainly divided into 4 layers, and is divided into, from outside to inside: insulating layer, isolation layer, control endoscope crooked snake bone, content. Wherein, the snake bone is a mechanism formed by a plurality of sections of annular hinges, a large gap is reserved between every two adjacent sections, and the bending of the snake bone is controlled by ropes.

In order to solve the above technical problems, according to a first aspect of the present disclosure, as shown in fig. 1, 3 and 6, there is provided an adjustable bend catheter assembly including a sheath tube 100, a support 200, a liner tube 300 and a plurality of steering wires, the sheath tube 100 having a bending section; the supporting member 200 is at least partially disposed at the curved section, and the supporting member 200 is disposed to extend along the extending direction of the sheath 100; wherein the support 200 is configured to: at least to enable the bending section of the sheath 100 to have a tensile modulus greater than the bending modulus; the lining pipe 300 is penetrated through the bending section, and one end of the lining pipe 300 close to the bending section is connected with the bending section; the liner pipe 300 is provided with a plurality of notches 310, the notches 310 are arranged at intervals along the extending direction of the liner pipe 300, and the notches 310 are arranged along the circumferential direction of the liner pipe 300; and the side of the liner tube 300 adjacent to the support 200 has a notch 310; a plurality of steering wires 400 are connected to the liner tube 300, the plurality of steering wires 400 being configured to drive bending deformation of the liner tube 300 and the curved section.

The sheath 100 has a distal end and a proximal section, the portion of the sheath 100 located at the distal end is a curved section, the portion of the sheath 100 located at the proximal section is an infusion section, wherein the distal end of the sheath 100, i.e., the distal end away from the operating handle of the endoscope, is an end that can be inserted into a human body first, and the proximal end of the sheath 100 is connected to the operating handle of the endoscope. The sheath is not limited to the distal insertion into the human body, and the infusion section can be inserted into the human body with the insertion portion set as needed.

In this application, the liner tube 300 is inserted into the curved section, one side of the liner tube 300 is provided with a plurality of notches 310, and the plurality of notches 310 are disposed at intervals along the extending direction (i.e., the axial direction) of the liner tube 300. Wherein the side of the liner tube 300 where the notch 310 is provided is close to the support 200, i.e. the notch 310 and the support 200 are located on the same side of the sheath tube 100. Obviously, by providing the notch 310, the flexural modulus of the liner 300 on the side where the notch 310 is provided can be reduced.

In the related art, when an interventional catheter is used for examination, a sheath needs to be inserted into a human body channel in a matching manner. However, in the case of inserting the sheath into the human body, most of the sheath is a hose which is easily bent, stretched or compressively deformed by the portion of the inner tube which is bent by the manipulation of the manipulation wire, and forces acting on the inner tube and the sheath are acting and reacting with each other, that is, the inner tube is driven to be bent by the manipulation of the manipulation wire, which causes the sheath to be stretched or compressed. The deformation of the sheath tube when stretched or compressed can reduce the bending stress of the lining tube, so that the bending degree of the lining tube is far lower than expected, and the bending effect is poor.

Thus, the present application can make the sheath 100 easily bent but the extension direction of the sheath 100 is difficult to be stretched by implanting the support 200 made of anisotropy. When the distal end bending portion of the endoscope is bent, the sheath tube 100 is not deformed by stretching due to the restriction of the support 200, and the bending state and the tendency of the two are the same, so that the bending amount of the system formed by the endoscope and the sheath tube 100 is overlapped, the bending amount of the adjustable bending catheter assembly can be increased, and the bending effect can be improved.

It will be readily appreciated that sheath 100 is most often a polymer-supported hose having elastic deformation capability. The sheath tube 100 has a receiving channel 110, the liner tube 300 is inserted into the receiving channel 110, and the supporting member 200 is not disposed in the receiving channel 110, so as to avoid compressing the space of the receiving channel 110 for receiving the liner tube 300, and a gap is provided between the liner tube 300 and the receiving channel 110, which can reduce the bending resistance of the bending section of the liner tube 300, and prevent the liner tube 300 from being blocked due to the expected large-scale bending deformation of the bending section and the sheath tube 100.

Optionally, the sheath 100 has a lower surface coefficient of friction, thereby reducing the frictional resistance between the curved section and the sheath 100, which can further reduce the probability of a seizing condition between the liner 300 and the sheath 100. Illustratively, the sheath 100 is made of a material having a low coefficient of friction.

Among them, the support 200 is provided in the sheath tube 100, and the support 200 is configured to have anisotropy, so that the support 200 is flexible and hardly stretchable. Obviously, the sheath 100 provided with the support 200 is hard to be stretched or compressed in the extending direction (i.e., the axial direction) thereof, and the sheath 100 is easily bent in the radial direction thereof, that is, it is represented by the difference in the tensile modulus of the support 200 in the axial direction and the flexural modulus in the radial direction of the sheath 100.

Obviously, since the amount of tensile or compressive deformation of the sheath 100 is limited, the sheath 100 does not stretch or compress when the curved section is bent.

By implanting the support 200 made of anisotropic material in the wall of the sheath 100, the bending section of the sheath 100 can be easily bent but hardly stretched by applying the adjustable bend catheter assembly provided by the present invention. For a sheath 100 reinforced with a support 200 on one side, the direction in which it cannot be deformed should be opposite to the direction in which the liner 300 cannot be deformed at the interface, i.e. the support 200 is located on the side of the sheath 100 near the notch 310 on the liner 300; when the lining pipe 300 is compressed, the lining pipe 300 is bent in response to compression to the side thereof provided with the notch 310, and at this time, the sheath pipe 100 is pulled, the portion where the support 200 is not provided is deformed in tension, but the portion where the support 200 is provided is not deformed in tension, and the sheath pipe 100 appears to be bent to the side provided with the notch 310. When the lining pipe 300 is pulled, the lining pipe 300 is bent in response to the side to which the notch 310 is not provided, and at this time, the sheath pipe 100 is pressed, the portion of the sheath pipe 100 where the support 200 is not provided is compressively deformed, but the portion of the sheath pipe 100 where the support 200 is provided is not compressively deformed, and the sheath pipe 100 appears to be bent toward the side away from the notch 310. Obviously, the bending states and trends of the two are the same, so that the bending amount of the adjustable bending catheter assembly is overlapped, the bending amount of the adjustable bending catheter assembly can be enhanced, the bending range is enlarged, the turning radius is reduced, and the trafficability is stronger. In addition, by modifying the inner liner tube 300 and the sheath tube 100 such that both the inner liner tube 300 and the sheath tube 100 have a certain elasticity and rigidity, the braided mesh tube can be omitted, thereby enabling the adjustable bend catheter assembly to have a small outer diameter size, a higher flexibility in bending, and a larger range of angles in which bending is possible.

As shown in fig. 3, the end of the notch 310 is formed with a tip, based on the above-described embodiment.

Illustratively, the notches 310 extend circumferentially of the liner tube 300, but do not form a closure, thereby enabling opposite ends to be formed. By providing a tip at the end of the notch 310, concentrated stress is introduced, making the flexural modulus of the notch 310 lower, that is, making it easier to bend the liner tube 300 at the notch 310. In other words, the tip may introduce stress concentrations, be more deformable, and have a longer life.

Alternatively, the slots 310 include a plurality of shapes, and the plurality of shapes of slots 310 may be alternately arranged. In particular, the slot 310 may be triangular, rectangular pointed, elongated shaped, elongated pointed, rectangular circular composite, etc. Of course, if the tip is not required to be provided at the end of the notch 310, the notch 310 may be provided in a rectangular shape or the like.

As shown in fig. 4 and fig. 5, based on the above embodiment, the liner tube 300 is divided into a first tube wall 320 and a second tube wall 330 in the circumferential direction, wherein the notch 310 is disposed on the first tube wall 320, the second tube wall 330 is disposed in a planar structure, and the first tube wall 320 is in a circular arc structure.

Illustratively, the liner tube 300 may have a circular cross-sectional shape, and may be defined by a first tube wall 320 and a second tube wall 330, for example: the first pipe wall 320 is configured as a circular arc, the second pipe wall 330 is configured as a planar structure, and in particular, may be a lath structure, the shape of the second pipe wall 330 of the liner pipe 300 is far smaller than the curvature of the first pipe wall 320, and the cross section of the type can convert a stress unit of the liner pipe 300 when the liner pipe is bent from a shell shape to a plate shape, so that the liner pipe is easier to elastically bend, and stress concentration at a certain position on the liner pipe 300 caused by processing precision and the like is reduced. It should be noted that the second pipe wall 330 is not cut by the notch 310, and it is apparent that the cross section of the liner pipe 300 formed by the first pipe wall 320 and the second pipe wall 330 is D-shaped.

As shown in fig. 8, the supporting member 200 is provided in a long strip structure on the basis of the above-described embodiment; the sheath 100 has a first channel 210 extending along an extending direction thereof, and the support member 200 can be inserted and fixed in the first channel 210.

That is, the sheath tube 100 has a first lumen 210 and a receiving channel 110, the receiving channel 110 is used to insert the inner tube 300, the inner tube 300 is used to insert the surgical instrument contents 500 such as an endoscope and a cable, and the first lumen 210 is used to mount the support 200. The first channel 210 can be provided on the side wall of the sheath tube 100 in advance, and the long support member 200 can be inserted and fixed into the first channel 210 in the later stage. The fixing structure between the support 200 and the sheath 100 may be a single-sided fixing structure, or may be a double-sided fixing structure. The fixed form thereof is not particularly limited herein, for example: the fixation may also be achieved by gluing, or by an interference fit or the like.

For example, the first channels 210 may be formed simultaneously during extrusion of the sheath 100, and the second channels 210 may be reamed later as required to meet the requirements of installing the support 200.

As shown in fig. 1 and 9, based on the above embodiment, the first channel 210 is configured as a stepped channel, and the large diameter section 211 of the first channel 210 is located at the curved section; wherein the supporting member 200 is fixedly inserted into the large diameter section 211.

The primary channel 210 is configured as a stepped channel, that is, the primary channel 210 has a large diameter section 211 and a small diameter section 212, and the large diameter section 211 and the small diameter section 212 are respectively disposed at opposite ends of the sheath tube 100. It should be noted that, since only the portion of the sheath 100 near the distal end bending portion affects the bending effect of the distal end bending portion, it is only necessary to provide the support 200 at the large-diameter section 211, and it is unnecessary to entirely ream the primary channel 210, so that the processing amount can be reduced, the use amount of the support 200 can be reduced, and the cost can be reduced.

In addition, since the small-diameter section 212 is not filled with the support 200, the small-diameter section 212 is kept in a hollow state, and the flexural modulus of the sheath 100 can be reduced, that is, the sheath 100 can be more easily bent.

By way of example, the cross-section of the support 200 may be provided as square, circular, oval, etc. The present invention is not particularly limited herein. The number of the supporting members 200 may be plural, or may be single, as long as the actual requirements can be satisfied.

It is easy to understand that if the support 200 is not required to be filled into the sheath 100, the diameter of the first channel 210 can be reduced in the design of the first channel 210, and the first channel 210 having a stepped shape can be manufactured in a post-processing manner through a tube expanding process. Also, the end surface of the support 200 made of an anisotropic material is fixedly coupled with the end surface of the sheath 100. Specifically, the connection between the end face of the support member 200 and the end face of the sheath tube 100 may refer to the above-mentioned gluing method, and the like, and will not be described herein.

The force required during the process of bending the liner tube 300 from un-bent to bent is progressively greater, i.e., less force is required when initiating the initial bending, when the unreinforced proximal end of the sheath tube 100 is sufficiently stiff itself to support the force of the initial bending. When initial bending starts, the angle between the bending section of the sheath 100 and the junction of the bending section and the part of the bending section is changed, the supporting piece 200 made of anisotropic materials is subjected to radial component force, acts on the inner wall of the sheath 100 to obtain support, and the supporting piece 200 is arranged to help reduce concentrated stress at the junction of the bending section and the infusion section of the sheath 100 and to facilitate the increase of service life.

As shown in fig. 6, on the basis of the above embodiment, the support 200 is embedded in the wall of the sheath 100, the support 200 is formed with a gap, and the sidewall portion of the sheath 100 is located in the gap, so that van der waals force is formed between the support 200 and the sheath 100.

The sheath 100 has a first lumen 210 disposed therethrough, and the support 200 is integrated into the first lumen 210 by the compounding process with the support 200 embedded therein. The support 200 exhibits anisotropy in its overall appearance, i.e., it is difficult to be axially stretched, but is easily bent.

The support 200 is directly carried by the sheath 100 when the polymer is extruded, the gaps in the support 200 are soaked and filled with the fluid material of the polymer, and the support 200 is fixed by forming van der Waals force after extrusion and cooling.

Illustratively, the support 200 is formed of a plurality of strips of anisotropic strip material side by side, with gaps formed between adjacent strips of material, such that upon extrusion of the tubing, the fluid material of the polymer from which the sheath 100 is made fills the gaps to achieve stable securement of the support 200 within the sheath 100. That is, the support 200 is fixed to the sheath 100 by van der Waals forces.

On the basis of the above embodiment, the sheath 100 is made of an insulating material.

In one embodiment, the sheath 100 may be an at least partially welded metal spring tube, providing it with high structural support strength and resiliency.

Of course, when the medical device system to which the sheath is applied needs to be insulated from the outside, in other embodiments, the sheath 100 may be made of an insulating material; alternatively, the metal spring tube can be coated with an insulating sheath.

That is, the sheath 100 is provided with an insulating function, and can insulate a power source, and the medical device to which the sheath is applied is an active medical device, for example: the active medical device is an endoscope. Of course, the active medical device may be inserted into the accommodating channel 110 of the sheath 100 to achieve insulation. Obviously, the mode is adopted without additionally adding an outermost insulating tube to realize insulation, and the scheme can reduce the total outer diameter of the active medical instrument and is beneficial to inserting the active medical instrument into a human body.

On the basis of the above embodiment, the support 200 includes at least one of carbon fiber wires, nickel titanium wires, and wire ropes.

Illustratively, the support 200 is made of a strip-like material having such properties as carbon fiber wire, nickel titanium wire, steel wire rope, etc., wherein the carbon fiber wire has a low flexural modulus, the nickel titanium wire has a pseudo-elasticity in the bending direction, and the steel wire rope has a low flexural modulus and is relatively significantly difficult to stretch-deform in the axial direction. It should be noted that the present invention is not limited to these materials, and may be other materials capable of achieving the same effects.

Alternatively, the support 200 is formed of a plurality of wire ropes arranged side by side. Likewise, the support 200 may be formed by arranging a plurality of carbon fiber wires or nickel titanium wires in parallel. Alternatively, the supporting member 200 is formed by mixing and arranging a plurality of carbon fiber wires, a plurality of nickel titanium wires and a plurality of steel wire ropes.

As shown in fig. 10, on the basis of the above embodiment, the thickness of the wall of the sheath tube 100 is different, the sheath tube 100 further has a second channel, the second channel is disposed to extend along the extending direction of the sheath tube 100, and the second channel is disposed at a portion where the wall of the sheath tube 100 is thicker.

Illustratively, the first channel 210, the second channel and the accommodating channel 110 are disposed in parallel, and by disposing the second channel on the wall of the sheath 100, the flexural modulus of the sheath 100 can be further reduced, so that the sheath 100 is easier to bend and deform, and the material is saved. In particular, when the accommodating channel 110 and the sheath 100 are in a non-coaxial state, the thickness of the wall of the sheath 100 is inevitably uneven, and obviously, the bending modulus of the wall is different at different thicknesses, and by providing the second channel on the side of the sheath 100 with the thicker wall, the bending modulus of the wall is reduced, so that the sheath is easier to bend.

As shown in fig. 7, on the basis of the above embodiment, the receiving channel 110 of the sheath 100 is coaxial with the sheath 100; wherein the receiving channel 110 is for receiving the liner tube 300.

The accommodating channel 110 is used for inserting the liner tube 300, the liner tube 300 is used for inserting contents, and the contents can be endoscope foreign matter forceps, cables, etc., of course, the insertion end of the endoscope with smaller outer diameter can also be inserted, for example: superfine endoscope. Obviously, the larger the inner diameter of the lining pipe is, the more convenient the inspection is, and the contents are convenient to penetrate. It should be noted that, the accommodating channel 110 and the sheath 100 are coaxial, so that the thickness of the sheath 100 at each position can be ensured to be approximately the same, that is, the bending modulus of the sheath 100 at each position is approximately the same, so that the bending portion at the front end is beneficial to driving the sheath 100 to bend.

It should be noted that, the support 200 and the sheath 100 are integrally formed by extrusion, so as to ensure that the accommodating channel 110 and the sheath 100 are coaxial. If the support 200 is installed by adopting the manner of forming the first cavity 210 by subsequent reaming, the difficulty of ensuring the coaxiality of the accommodating channel 110 and the sheath 100 is large due to the subsequent need of reaming the first cavity 210, and enough machining allowance needs to be reserved on the pipe wall, so that the accommodating channel 110 is prevented from being affected when the first cavity 210 is machined.

As shown in fig. 7, the support 200 is located in a sector having a central angle of 90 ° in the cross section of the sheath 100, on the basis of the above embodiment.

That is, it is not preferable to set the support 200 over a sector of 90 ° in the cross section of the sheath 100. If the support member 200 is disposed in the cross section of the sheath 100 beyond a sector area with a central angle of 90 ° in the cross section of the sheath 100, for example: the central angle of the supporting piece 200 on the cross section of the sheath tube 100 is 90 degrees to 180 degrees, and the supporting piece 200 can influence the bending of the sheath tube 100 to a small extent; the central angle at which the support 200 is positioned on the cross section of the sheath 100 is greater than 180 °, and the support 200 may greatly affect the bending of the sheath 100 or may cause the sheath 100 to fail to bend.

Based on the above embodiment, the liner tube 300 is a thin tube with a penetrating slit, and may be made of a metal material such as nickel titanium or stainless steel, or a polymer material, and engraved by laser cutting or spark cutting. In addition, the liner 300 should at least satisfy at the same time: 1) The elastic modulus of the part where the notch 310 is not arranged is large, and the part is basically not subjected to stretching deformation (< 2%) under the action of the force of generally less than or equal to 30N; 2) When the pipe wall is sufficiently thin, the portion of liner 300 where notches 310 are located has a low flexural modulus, and typically a force of 30N or less can cause complete bending until contact or near contact occurs where no notches 310 are located. The nickel-titanium material with pseudo elasticity is optimal, stainless steel materials commonly used for medical instruments can be used under the condition that the requirement on the recycling frequency is not very high (such as a disposable endoscope), and polymer materials can be used when the nickel-titanium material is not extremely sensitive to the external diameter.

As shown in fig. 1, the number of the manipulation wires 400 is one on the basis of the above embodiment, and the manipulation wires 400 are configured to be able to transmit pushing force and pulling force; wherein the steering wire 400 is connected to an end of the liner tube 300 remote from the curved section.

Illustratively, taking an endoscope as an example, the manipulation wire 400 has a distal end and a proximal end, the distal end of the manipulation wire 400 and one end of the liner tube 300 far from the bending section are connected near the side where the notch 310 is provided, the proximal end of the manipulation wire 400 is connected to the manipulation handle of the endoscope, and the manipulation wire is capable of being elastically deformed to accommodate bending of the liner tube 300.

The steering wire 400 should have a certain stiffness by itself or by other restrictions, be stiff in the axial direction, and be capable of transmitting both tensile and pushing forces. Illustratively, in an endoscope system, the curvature of the curved section is large and the curvature of the other locations is small, so that the use of a stiffer material for steering wire 400 does not affect the intended bending of the system. However, in some special use cases (superfine system, or the non-active bending section of endoscope is also inserted in a tortuous narrow channel), the control wire 400 is limited by the system and can not use more rigid materials or thicken, and can use anisotropic materials such as nickel titanium, etc., so that the bending modulus of the control wire can be reduced at the same axial rigidity; and is made sufficiently rigid in the axial direction by restricting its passage.

In this example, when the steering wire 400 is pulled, the liner tube tends to become longer and thus bend upward; the sheath 100 incorporating the support made of anisotropic material behaves as a stressed, the anisotropic material cannot be compressed/stretched, the non-reinforced side tends to shorten, and so bend upwards, the two incorporating, the adjustable catheter assembly behaves as an upward bend. When steering wire 400 is pushed, then the adjustable catheter assembly appears to bend downward.

As shown in fig. 2, the number of the manipulation wires 400 is two based on the above embodiment, and one of the two manipulation wires 400 is connected to one end of the liner tube 300 remote from the bending section, and the other is connected to the bending section.

The reason for limiting the maximum thickness of the endoscope system is that there is too much content 500, e.g. ropes, rope channels, in the tip bend that requires active bending, whereas the distance between the hinges is too long, the maximum angle that each hinge can bend is too large, the curvature is uneven or the discrete fitted line segments that make up the overall curvature are too long, so the tip bend overall fill rate must be controlled to be small in order to avoid large scratches or additional parasitic friction.

The reason that the conventional endoscope is thick in bending portion is that: the soft insulating sheath is formed by the fact that the content 500 is thicker and thicker, the braided mesh tube is formed with a thickness, the insulating/sealing soft insulating sheath is formed with a thickness, gaps left by scraping the rope channels/the content 500 are overcome, and the content 500 is excessively bent and bent or suddenly damped and greatly integrated due to inconsistent curvature.

In the present application, since the two control wires 400 only transmit tensile force, there is no special requirement for axial rigidity, and the system can be realized by using the most common thin steel wire ropes, so that the system is more flexible and the compliance is improved. To make more reasonable use of space, the two steering wires 400 may use rectangular cross sections instead of circular cross sections, making space more compact and making the endoscope system thinner.

Illustratively, the notch 310 of the liner tube 300 and the support 200 are located on the same side of the sheath tube 100, and the two manipulation wires 400 are divided into a first manipulation wire and a second manipulation wire, wherein the first manipulation wire and the liner tube 300 are connected at a side of the liner tube 300, which is far from one end of the curved section of the sheath tube 100 and is close to the notch 310, and the second manipulation wire and the sheath tube 100 are connected at a side far from the support 200.

When the first steering wire is pulled, the liner tube 300 tends to lengthen, so that it bends upward; the sheath 100 with the support 200 exhibits compression and the support 200 cannot be compressed/stretched, and the side of the sheath 100 where the support 200 is not disposed tends to shorten, so that the sheath 100 bends upward and the two combine to exhibit upward bending of the adjustable bend catheter assembly.

When the second manipulation wire is pulled, the sheath 100 having the support 200 is expressed as being pulled, the support 200 cannot be compressed/stretched, and the side of the sheath 100 where the support 200 is not provided tends to lengthen, so that the sheath 100 is bent downward; the liner tube 300 is not directly stressed, but is flexible in both bending directions in the plane, following the bending of the sheath tube 100, and the two combine to allow the adjustable catheter assembly to exhibit downward bending.

Based on the above embodiment, the liner tube 300 and the sheath tube 100 are clearance fit.

That is, since the lining pipe 300 and the sheath pipe 100 are both subjected to a wide range of expected bending deformation, the two pipes are subjected to bending (cross-sectional deformation) other than bending, and therefore a gap is provided to prevent seizure. In addition, in order to further avoid the seizing phenomenon, the sheath tube 100 should use a material having a small elastic coefficient to accommodate the deformation of the inner liner tube 300.

On the basis of the above embodiment, the sheath tube 100 has a third channel, and the third channel is extended along the extending direction of the sheath tube 100; wherein, the control wire 400 is disposed through the third channel.

When the number of the control wires 400 is one, the third channel is set to limit the channels of the control wires 400, so that when the control wires 400 are pushed at one end and are resisted at the other end, the tendency of the original tendency to radial swing is limited by the diameter of the third channel and cannot be deformed, and the axial pushing force is better conducted. Of course, the third cavity is designed to be circular and its expanded shape for the purpose of reducing contact area and friction force, improving conduction efficiency, and for size reasons, the steering wires will not escape to both sides of the third cavity, so that pushing force and pulling force can be applied.

In addition, by providing a third lumen, the manipulation wire 400 can be isolated from the contents 500 within the receiving channel 110, reducing extrusion and wear.

As shown in fig. 11, 12 and 13, each notch 310 of the liner 300 has different rigidity on both sides of a certain section on the basis of the above embodiment, the rigidity difference is divided by a plane parallel to the axis and perpendicular to the cross section of the liner 300, wherein the radial rigidity of one side is equal to the inherent rigidity of the liner 300 without the notch 310, and the rigidity of the other side is weakened after the notch 310 is provided, and the rigidity dividing plane divides the illustrated part into two parts P ₁ And P ₂ The portions on both sides have rigidity differencesP when subjected to axial force ₁ Side-squeeze, relative to P ₂ Stress concentration and deformation are generated.

When the bending direction between the notches 310 is uniformed, the liner tube 300 is expected to bend, and F is a driving force and F' is a restraining force as shown in fig. 12. When the liner tube 300 is pressurized, the notch 310 tends to be pressed, and the liner tube 300 appears to bend toward the notch 310 side.

Correspondingly, as shown in FIG. 13, when the liner 300 is pulled, the notch 310 tends to be stretched and the liner 300 appears to bend away from the notch 310.

Wherein, when the rigidity index surfaces of the sections of the notches 310 are not parallel, the bending direction of the liner tube 300 is the sum of the expected bending components of the sections, and a pre-calculated bending form can be realized.

According to a second aspect of the present disclosure, a medical device is provided that includes an adjustable bend catheter assembly.

Since the above-mentioned bendable catheter assembly has the above-mentioned technical effects, the medical device including the bendable catheter assembly should have the same technical effects, and will not be described herein.

By way of example, the medical instrument may be an endoscope parent scope, an endoscope child scope, an endoscope foreign body forceps, or the like. And in this application, an endoscopic foreign matter clamp is taken as an example.

The endoscope foreign body forceps are provided with handles for controlling the foreign body forceps, and drive the control wire 400 to move, so that the control of the common expected use of the instrument is realized; the bending control handle drives the control wire 400 to move, so that the bending of the instrument is controlled; the handle has an electrical terminal through which high frequency electricity received by the system is transmitted, passing through the head end of the forceps, wherein the sheath 100 made of polymer provides insulation.

Any particular values in all examples shown and described herein are to be construed as merely illustrative and not a limitation, and thus other examples of exemplary embodiments may have different values.

It should be noted that: like reference numerals and letters denote like items in the following figures, and thus once an item is defined in one figure, no further definition or explanation thereof is necessary in the following figures.

The above examples merely represent a few embodiments of the present invention, which are described in more detail and are not to be construed as limiting the scope of the present invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention.

Claims

1. An adjustable bend catheter assembly, the adjustable bend catheter assembly comprising:

a sheath having a curved section;

the support piece is at least partially arranged on the bending section and extends along the extending direction of the sheath tube; wherein the support is configured to at least enable a tensile modulus of the curved section to be greater than a flexural modulus;

the lining pipe penetrates through the bending section, and one end, close to the bending section, of the lining pipe is connected with the bending section; the lining pipe is provided with a plurality of notches, the notches are sequentially arranged at intervals along the extending direction of the lining pipe, the notches extend along the circumferential direction of the lining pipe, and one side, close to the supporting piece, of the lining pipe is provided with the notches;

2. The adjustable bend catheter assembly of claim 1 wherein the notch is formed with a tip at an end thereof.

3. The adjustable bend conduit assembly of claim 1 wherein the liner tube is divided in its circumference into a first tube wall and a second tube wall; the notch is formed in the first pipe wall, and the second pipe wall is of a planar structure.

4. The adjustable bend catheter assembly of any one of claims 1-3 wherein the support is provided as an elongated structure;

the sheath tube is provided with a first cavity channel extending along the extending direction of the sheath tube, and the supporting piece is fixedly arranged in the first cavity channel in a penetrating mode.

5. The adjustable bend conduit assembly of claim 4 wherein the first lumen is configured as a stepped bore and a large diameter section of the first lumen is located at the bend section; wherein the supporting piece is fixedly arranged on the large-diameter section in a penetrating way.

6. The adjustable bend catheter assembly of claim 1 wherein the support is embedded in a wall of the sheath, the support defining a gap, a sidewall portion of the sheath being positioned within the gap such that van der waals forces are formed between the support and the sheath.

7. The adjustable bend catheter assembly of claim 1 wherein the sheath is made of an insulating material.

8. The adjustable bend catheter assembly of claim 4 wherein the support member comprises at least one of carbon fiber wire, nickel titanium wire, and steel wire rope.

9. The adjustable bend catheter assembly of claim 4 wherein the sheath has a wall of different thickness, the sheath further having a second lumen extending along the direction of extension of the sheath, and the second lumen being disposed in a thicker portion of the sheath wall.

10. The adjustable bend catheter assembly of claim 4 wherein the support member is located within a sector of 90 ° of center angle in the cross section of the sheath.

11. The adjustable bend catheter assembly of claim 1 wherein the number of steering wires is one and the steering wires are configured to be elastically deformable and to transmit both pushing and pulling forces; wherein, control the silk connect in the inside lining pipe is kept away from the one end of bending section.

12. The adjustable bend catheter assembly of claim 1 wherein the number of steering wires is two, one of the steering wires being connected to an end of the liner tube remote from the bend section and the other being connected to the bend section.

13. The adjustable bend catheter assembly of claim 11 or 12 wherein the sheath has a third lumen extending along the direction of extension of the sheath; wherein, control the silk and wear to locate the third chamber way.

14. The adjustable bend catheter assembly of claim 1 wherein the liner tube and the sheath tube are clearance fit.

15. A medical device comprising the adjustable bend catheter assembly of any one of claims 1-14.