Balloon dilatation catheter

Abstract

The present application relates to a kind of balloon dilatation catheter, including operating handle, catheter, balloon skeleton, balloon body, first adjusting piece, second adjusting piece and adjusting locking mechanism. Operating handle is arranged at the proximal end of catheter, balloon skeleton is axially sleeved in the distal end of catheter, balloon body is axially clamped and is sleeved outside balloon skeleton, and cross section is C type, adjusting locking mechanism can adjust and lock the relative position between the proximal end and the distal end of balloon skeleton. When first adjusting piece is moved to the proximal end and / or second adjusting piece is moved to the distal end, the distance between the proximal end and the distal end of balloon skeleton is reduced, balloon skeleton is radially expanded, balloon body C type opening is enlarged, and balloon body is radially expanded;When first adjusting piece is moved to the distal end and / or second adjusting piece is moved to the proximal end, the distance between the proximal end and the distal end of balloon skeleton is increased, balloon skeleton is radially contracted, balloon body C type opening is reduced, and balloon body is radially reduced.The balloon dilatation catheter of the present application has better stability, and can flexibly adjust the expansion degree.

Description

TECHNICAL FIELD

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

[0002] The balloon dilatation catheter is a kind of medical intervention device, which can be used to dilate the narrow cavity organs under the guidance, such as treating the thrombus blockage in peripheral blood vessels, dredging the blood vessels, dilating the blood vessel channel, and widening the nasal cavity, gastrointestinal tract, urethra and other body lumen. The balloon dilatation catheter is a soft catheter with an inflatable balloon at the head end. In the non-inflatable state, the balloon catheter enters the target lesion site, and after successful treatment, the balloon can be retracted to withdraw the balloon catheter to the outside of the body. The most common balloon dilatation catheter on the market is a liquid-filled balloon dilatation catheter, which is inflated by inputting liquid into the balloon. The liquid used can be a mixture of sterile injection liquid and contrast liquid. The liquid-filled balloon dilatation catheter is widely used in the field of intervention vascular dilatation. However, in some application situations, the liquid-filled balloon has the problems of poor stability after expansion and inability to adjust the expansion degree and the shape after expansion at any time, resulting in unsatisfactory dredging or expansion effect. SUMMARY

[0003] The purpose of the present application is to provide a balloon dilatation catheter with good stability after balloon expansion and flexible adjustment of balloon expansion degree.

[0004] To achieve the above-mentioned purpose, the technical scheme adopted by the present application is:

[0005] A balloon dilatation catheter comprises an operating handle; a catheter having a first lumen for passing a guide wire and a second lumen for passing gas or liquid, the operating handle being arranged at a proximal end of the catheter; a balloon skeleton capable of radial expansion or radial contraction, the balloon skeleton being sleeved on an outer periphery of a distal end of the catheter in an axial direction, a proximal end of the balloon skeleton and a distal end of the balloon skeleton being capable of sliding along the catheter in the axial direction respectively; a balloon body having a compliance of ≤5%, the balloon body being clamped and sleeved on an outside of the balloon skeleton in the axial direction, the balloon body having a C-shaped cross section, the balloon body being provided with a balloon body filling channel for connecting an inside of the balloon body and the second lumen; a clamping assembly arranged between the balloon skeleton and the balloon body for connecting the balloon skeleton and the balloon body; a first adjusting member fixedly connected with the distal end of the balloon skeleton and slidingly connected with the proximal end of the balloon skeleton; a second adjusting member fixedly connected with the proximal end of the balloon skeleton; an adjusting and locking mechanism capable of adjusting and locking a relative position between the proximal end of the balloon skeleton and the distal end of the balloon skeleton; when the first adjusting member is moved towards the proximal end and / or the second adjusting member is moved towards the distal end, a distance between the proximal end and the distal end of the balloon skeleton is reduced, the balloon skeleton is expanded in the radial direction, and then a C-shaped opening of the balloon body is expanded, and the balloon body is expanded in the radial direction; when the first adjusting member is moved towards the distal end and / or the second adjusting member is moved towards the proximal end, the distance between the proximal end and the distal end of the balloon skeleton is increased, the balloon skeleton is contracted in the radial direction, and then the C-shaped opening of the balloon body is reduced, and the balloon body is contracted in the radial direction.

[0006] Preferably, a filling port is arranged on a side wall of the balloon body close to the balloon skeleton, one end of the balloon body filling channel is connected with the filling port, the other end of the balloon body filling channel passes through the balloon skeleton and is connected with the second lumen, and the balloon body filling channel is provided with a reserved fold. The design of the reserved fold allows the balloon body filling channel to have a pulling allowance when the C-shaped balloon is expanded in the radial direction.

[0007] Preferably, the clamping assembly comprises a guide rail fixedly arranged on a side wall of the balloon body close to the balloon skeleton in the axial direction and a sliding block fixedly arranged on the balloon skeleton and capable of slidingly connecting with the guide rail.

[0008] Further preferably, the sliding block comprises a plurality of sliding blocks distributed in the axial direction.

[0009] Further preferably, the guide rail is made of stainless steel, for example, 304 stainless steel.

[0010] Further preferably, the guide rail is provided with a groove-shaped slide, and the sliding block is located in the groove-shaped slide, and the material of the groove-shaped slide is a visible high polymer material. For example, the material of the groove-shaped slide can be a silicone rubber material added with a contrast medium such as iodine or barium, so that it has a good developing effect under X-rays, and has excellent biocompatibility and flexibility, and has a good sliding effect during the deformation of the balloon framework.

[0011] According to a specific and preferred embodiment, the guide rail comprises a first guide rail extending from the distal end of the balloon body to the middle part of the balloon body, and a second guide rail extending from the proximal end of the balloon body to the middle part of the balloon body, and there is a distance between the proximal end of the first guide rail and the distal end of the second guide rail, and the sliding block comprises a sliding block capable of being slidably connected with the first guide rail and a sliding block capable of being slidably connected with the second guide rail.

[0012] Further, a net basket is arranged between the clamping assembly and the catheter, the net basket is a hollow structure with two open ends, one end of the net basket is fixedly connected with the proximal end of the first guide rail and the distal end of the second guide rail respectively, and the other end of the net basket is fixedly connected with the catheter, and the balloon inflation conduit is arranged in the net basket.

[0013] Further, the balloon inflation conduit is in the shape of a funnel with an open end, and the open end of the balloon inflation conduit is in communication with the inflation port.

[0014] Further, the net basket is in the shape of a funnel with an open end, and the open end of the net basket is connected with the first guide rail and the second guide rail.

[0015] Further, the material of the net basket is a flexible material, such as silicone.

[0016] According to a specific and preferred embodiment, the first adjusting member is a hollow tubular structure, which is slidably sleeved on the catheter in the axial direction, the balloon framework is sleeved outside the first adjusting member in the axial direction, and the distal end of the balloon framework is fixedly connected with the distal end of the first adjusting member, a strip-shaped groove extending in the axial direction is formed on the part of the first adjusting member located in the balloon framework, and the balloon inflation conduit is in communication with the second lumen through the balloon framework and the strip-shaped groove; the second adjusting member is a hollow tubular structure, which is slidably sleeved on the first adjusting member in the axial direction, and the distal end of the second adjusting member is fixedly connected with the proximal end of the balloon framework.

[0017] Preferably, the adjusting and locking mechanism comprises a first matching part arranged on the first adjusting member, a second matching part arranged on the second adjusting member, and a third matching part arranged on the operation handle and capable of being matched with the first matching part and the second matching part respectively.

[0018] Preferably, the adjusting and locking mechanism comprises a first matching part arranged on the first adjusting member, a second matching part arranged on the second adjusting member, and a third matching part arranged on the operating handle and capable of matching with the first and second matching parts respectively.

[0019] According to some specific and preferable embodiments, the operating handle is provided with a receiving cavity into which the first and second adjusting members extend respectively, the first matching part is a first external thread formed on the outer sidewall of the proximal end of the first adjusting member, the second matching part is a second external thread formed on the outer sidewall of the proximal end of the second adjusting member, the screw directions of the first and second external threads are opposite, the pitches of the first and second external threads are the same or different, and the third matching part comprises a dial and a transmission member, the dial is rotatably arranged on the operating handle along the direction of its own axis and partially located in the receiving cavity, the transmission member is in meshing connection with the dial, the transmission member is rotatably arranged in the receiving cavity along the direction of its own axis, the transmission member is axially sleeved on the second adjusting member, a first internal thread is formed on the inner sidewall of the proximal end of the transmission member, a second internal thread is formed on the inner sidewall of the distal end of the transmission member, the proximal end of the transmission member and the proximal end of the first adjusting member are in matching connection through the first external thread and the first internal thread, the distal end of the transmission member and the proximal end of the second adjusting member are in matching connection through the second external thread and the second internal thread, when the dial rotates along a first direction about the direction of its own axis under the action of external force, the dial drives the transmission member to rotate along a third direction about the direction of its own axis, thereby driving the first adjusting member to move towards the proximal end and the second adjusting member to move towards the distal end, when the dial rotates along a second direction about the direction of its own axis under the action of external force, the dial drives the transmission member to rotate along a fourth direction about the direction of its own axis, thereby driving the first adjusting member to move towards the distal end and the second adjusting member to move towards the proximal end, one of the first and second directions is clockwise and the other is counterclockwise, one of the third and fourth directions is clockwise and the other is counterclockwise.

[0020] Preferably, the balloon framework has a plurality of mesh structures connected in sequence along the axial and circumferential directions respectively.

[0021] Preferably, the distal end of the balloon framework is provided with a first ring which is radially invariable, and the proximal end of the balloon framework is provided with a second ring which is radially invariable.

[0022] Preferably, the balloon framework is formed by weaving silk threads or cutting a hollow tube.

[0023] Preferably, the outer surface of the balloon and the balloon inflation channel is covered with a braided layer, which can further reduce the compliance of the balloon.

[0024] Preferably, the balloon and the balloon inflation channel are integrally formed.

[0025] Preferably, the outer surface of the balloon is coated with a hydrophilic coating.

[0026] Preferably, the material of the balloon is a polymer material.

[0027] Preferably, the material of the balloon is a polymer material.

[0028] According to some embodiments, the operation handle is provided with a first opening communicating with the first lumen and a second opening communicating with the second lumen.

[0029] Preferably, the balloon dilation catheter further comprises a catheter sheath sleeved outside the catheter and the balloon. The balloon dilation catheter of the present application is suitable for a catheter sheath of a conventional size, preferably a catheter sheath with an inner diameter of 3-8F. In actual application, the catheter sheath is selected according to the size of the lesion vessel.

[0030] Thanks to the above technical solution, the present application has the following advantages compared with the prior art:

[0031] The balloon dilation catheter of the present application has better stability after balloon dilation and can flexibly adjust the degree of balloon dilation, thereby improving the dredging and dilation effect. The balloon dilation catheter of the present application can be held by one hand and operated by the thumb, which is convenient, fast and flexible. BRIEF DESCRIPTION OF DRAWINGS

[0032] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed in the embodiment description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor.

[0033] Figure 1 Structure schematic diagram of the balloon dilation catheter of Example 1 in the radial dilation state of the balloon;

[0034] Figure 2 Structure schematic diagram (partial cross-sectional view) of the balloon dilation catheter of Example 1 in the radial dilation state of the balloon;

[0035] Figure 3 is Figure 2 Enlarged view of A in FIG. 6;

[0036] Figure 4Partial structure diagram of the balloon skeleton of the balloon dilatation catheter of Example 1 and partial structure of the catheter (the balloon skeleton is in a radially contracted state);

[0037] Figure 5 Structure diagram of the balloon of the balloon dilatation catheter of Example 1;

[0038] Figure 6 Sectional structure diagram of the balloon inflation conduit of the balloon of the balloon dilatation catheter of Example 1;

[0039] Figure 7 Sectional structure diagram of the balloon dilatation catheter of Example 1 in a radially expanded state of the balloon (the balloon skeleton is hidden);

[0040] Figure 8 Structure diagram of the balloon dilatation catheter of Example 2 in a radially expanded state of the balloon;

[0041] Figure 9 Partial structure diagram of the balloon dilatation catheter of Example 2 in a radially expanded state of the balloon (the operating handle is hidden);

[0042] Figure 10 Partial structure diagram of the balloon dilatation catheter of Example 2 in a radially expanded state of the balloon (the operating handle and the balloon are hidden),

[0043] In the above figures: 1, operating handle; 11, first inlet and outlet; 12, second inlet and outlet; 2, catheter; 21, first lumen; 22, second lumen; 3, balloon skeleton; 31, first ring; 32, second ring; 4, balloon; 41, balloon inflation conduit; 51, first guide rail; 52, second guide rail; 53, basket; 6, first adjusting member; 61, bar-shaped slot; 7, second adjusting member; 81, first external thread; 82, second external thread; 83, dial; 84, transmission member. DETAILED DESCRIPTION

[0044] Hereinafter, only certain exemplary embodiments are simply described. As those skilled in the art can recognize, the described embodiments can be modified in various different ways without departing from the spirit or scope of the embodiments of the present application. Therefore, the drawings and the description are considered to be exemplary in nature rather than limiting.

[0045] In the description of the present application, it should be understood that the distal end refers to the end of the instrument or component far from the operator, the proximal end refers to the end of the instrument or component close to the operator; the axial direction refers to the direction parallel to the center line connecting the distal end and the proximal end of the instrument or component, the radial direction refers to the direction perpendicular to the axial direction; the inner and outer are defined as the position relative to the center of the instrument or component, wherein the inner is the position close to the center of the instrument or component, and the outer is the position away from the center of the instrument or component. The above orientation words are only for the convenience of describing the embodiments of the present application and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the embodiments of the present application.

[0046] In the description of the present application, unless otherwise explicitly specified and limited, the terms "connected", "fixed" and the like should be understood in a broad sense, for example, can be fixed connection, can also be detachable connection, or can be integrated. For those skilled in the art, the specific meaning of the above terms in the embodiments of the present application can be understood according to the specific circumstances.

[0047] In the description of the present application, multiple refers to two or more.

[0048] In the present application, the calculation method of "compliance" is: compliance = {(diameter @ rated burst pressure - diameter @ nominal pressure) / (rated burst pressure - nominal pressure)} x 100%, the nominal pressure refers to the pressure borne by the balloon during normal operation, and the rated burst pressure refers to the maximum pressure borne by the balloon at the moment of rupture.

[0049] The embodiments of the present application will be described in detail below with reference to the accompanying drawings.

[0050] Embodiment 1

[0051] This embodiment is an embodiment of the balloon dilatation catheter of the present application, specifically as shown in Figures 1-7 It includes an operating handle 1, a catheter 2, a balloon skeleton 3, a balloon body 4, a clamping assembly, a first adjusting member 6, a second adjusting member 7 and an adjusting locking mechanism.

[0052] Specifically, the catheter 2 has a first lumen 21 for passing a guide wire and a second lumen 22 for passing gas or liquid. The first lumen 21 extends from the proximal end to the distal end of the catheter 2 and is open at both ends. The second lumen 22 extends from the proximal end to the distal end of the catheter 2 but does not reach the distal end, i.e. the distal end of the second lumen 22 is in a blocked state. In this embodiment, the cross section of the first lumen 21 is circular, and the cross section of the second lumen 22 is crescent-shaped. In this embodiment, the first lumen 21 can pass a guide wire with a size ≤0.035 inch.

[0053] Specifically, the operation handle 1 is sleeved on the proximal end of the catheter 2, and the operation handle 1 is internally provided with a containing cavity, and the operation handle 1 is provided with a first opening 11 communicating with the first lumen 21 and a second opening 12 communicating with the second lumen 22.

[0054] Specifically, the balloon skeleton 3 can be radially expanded or radially contracted, the balloon skeleton 3 is sleeved on the outer periphery of the distal end of the catheter 2 along the axial direction, and the proximal end of the balloon skeleton 3 and the distal end of the balloon skeleton 3 can slide along the axial direction of the catheter 2, respectively. In this embodiment, the balloon skeleton 3 has a plurality of mesh structures connected in sequence along the axial direction and the circumferential direction, respectively, the distal end of the balloon skeleton 3 is provided with a first ring 31 which is radially invariable, the proximal end of the balloon skeleton 3 is provided with a second ring 32 which is radially invariable, and the balloon skeleton 3 is made of X-ray visible and biocompatible PEEK material (TECAPEEK MT XRO GREEN).

[0055] Specifically, the compliance of the balloon body 4 is ≤5%, the balloon body 4 is sleeved on the outside of the balloon skeleton 3 along the axial direction, the cross section of the balloon body 4 is C-shaped, and the balloon body 4 is provided with a balloon filling pipe 41 for communicating the inside of the balloon body 4 and the second lumen 22. In this embodiment, the side wall of the balloon body 4 close to the balloon skeleton 3 is provided with a filling port, one end of the balloon filling pipe 41 is funnel-shaped with an open end, and the open end communicates with the filling port, the other end is laser welded with the second lumen 22 through the balloon skeleton 3, and the balloon filling pipe 41 is provided with a reserved wrinkle. The balloon body 4 is made of PEBAX material, and the balloon body 4 and the balloon filling pipe 41 are integrally formed by blow molding, the flat balloon body is deformed by C-shaped bending, and is shaped at high temperature. The outer surface of the balloon body 4 is coated with a hydrophilic coating, and is cured by ultraviolet rays. The outer surface is covered with a woven layer (including the balloon filling pipe) using PET woven wire. After the woven layer is reinforced, the shape of the balloon body 4 is more stable, the flexibility is good, and the compliance can be reduced to less than 5%. The above process is a conventional process in the art, which will not be described here.

[0056] Specifically, the clamping assembly is arranged between the balloon skeleton 3 and the balloon body 4 for connecting the balloon skeleton 3 and the balloon body 4. In the embodiment, the clamping assembly includes a guide rail, a sliding block and a mesh basket 53. The guide rail is fixedly arranged on the side wall of the balloon body 4 close to the balloon skeleton 3 in the axial direction and includes a first guide rail 51 and a second guide rail 52. The first guide rail 51 extends from the distal end of the balloon body 4 to the middle part of the balloon body 4, and the second guide rail 52 extends from the proximal end of the balloon body 4 to the middle part of the balloon body 4. There is a distance between the proximal end of the first guide rail 51 and the distal end of the second guide rail 52. The first guide rail 51 and the second guide rail 52 are made of 304 stainless steel and are pasted to the opposite sides of the inflation port of the balloon body 4 by glue. The first guide rail 51 and the second guide rail 52 are both provided with a groove-shaped slide way extending from the proximal end to the distal end, and the groove-shaped slide way is made of silicone rubber added with contrast agent. The sliding block includes a plurality of sliding blocks distributed in the axial direction. The groove-shaped slide way of the first guide rail 51 and the groove-shaped slide way of the second guide rail 52 are both slidably connected with the sliding blocks. In the embodiment, the sliding block is a spherical ball fixedly arranged at the vertex of the mesh hole and protruding outward, which is embedded in the groove-shaped slide way and has good sliding effect. The mesh basket 53 is a hollow structure with two open ends. The two sides of the one end opening of the mesh basket 53 are fixedly connected with the proximal end of the first guide rail 51 and the distal end of the second guide rail 52, respectively. The other end opening of the mesh basket 53 is fixedly connected with the catheter 2, and the balloon inflation pipeline 41 is arranged in the mesh basket 53. The mesh basket 53 is welded with the catheter 2, the first guide rail and the second guide rail, respectively, so that they can be an integral whole. When the balloon skeleton 3 is deformed, the integral whole hardly moves in the axial direction. The mesh basket 53 is in the shape of a funnel with an open end and is connected with the proximal end of the first guide rail 51 on one side and the distal end of the second guide rail 52 on the other side. The mesh basket 53 is made of flexible material and can be deformed by pulling.

[0057] Specifically, the first adjusting member 6 is fixedly connected with the distal end of the balloon skeleton 3 and slidably connected with the proximal end of the balloon skeleton 3. The second adjusting member 7 is fixedly connected with the proximal end of the balloon skeleton 3. The adjusting and locking mechanism can adjust and lock the relative position between the proximal end of the balloon skeleton 3 and the distal end of the balloon skeleton 3. The adjusting and locking mechanism includes a first matching part arranged on the first adjusting member 6, a second matching part arranged on the second adjusting member 7 and a third matching part arranged on the operating handle 1 and capable of matching with the first matching part and the second matching part, respectively. When the first adjusting member 6 moves towards the proximal end and the second adjusting member 7 moves towards the distal end, the distance between the proximal end and the distal end of the balloon skeleton 3 is reduced, the radial direction of the balloon skeleton 3 is expanded, the C-shaped opening of the balloon body 4 is expanded, and the radial direction of the balloon body 4 is expanded. When the first adjusting member 6 moves towards the distal end and the second adjusting member 7 moves towards the proximal end, the distance between the proximal end and the distal end of the balloon skeleton 3 is increased, the radial direction of the balloon skeleton 3 is contracted, the C-shaped opening of the balloon body 4 is reduced, and the radial direction of the balloon body 4 is contracted.

[0058] In the embodiment, the first adjusting member 6 is a hollow tubular structure, which is sleeved on the catheter 2 in the axial direction, the balloon skeleton 3 is sleeved on the outside of the first adjusting member 6 in the axial direction, and the distal end of the balloon skeleton 3 is fixedly connected with the distal end of the first adjusting member 6, a strip-shaped slot 61 extending in the axial direction is formed on the part of the first adjusting member 6 in the balloon skeleton 3, the balloon inflation pipeline 41 passes through the balloon skeleton 3 and the strip-shaped slot 61 to communicate with the second lumen 22, and the basket 53 passes through the balloon skeleton 3 and the strip-shaped slot 61 to connect the strip-shaped slot 61 with the outer wall of the catheter 2; the second adjusting member 7 is a hollow tubular structure, which is sleeved on the first adjusting member 6 in the axial direction, and the distal end of the second adjusting member 7 is fixedly connected with the proximal end of the balloon skeleton 3.

[0059] In the embodiment, the first adjusting member 6 and the second adjusting member 7 extend into the accommodating cavity respectively, the first matching part is a first external thread 81 formed on the outer side wall of the proximal end of the first adjusting member 6, the second matching part is a second external thread 82 formed on the outer side wall of the proximal end of the second adjusting member 7, the screw directions of the first external thread 81 and the second external thread 82 are opposite, the pitches of the first external thread 81 and the second external thread 82 are the same or different, the third matching part includes a knob 83 and a transmission member 84, the knob 83 is rotatably arranged on the operating handle 1 in the direction of its own axis and partially located in the accommodating cavity, the transmission member 84 is in meshing connection with the knob 83, the transmission member 84 is rotatably arranged in the accommodating cavity in the direction of its own axis, the transmission member 84 is sleeved on the second adjusting member 7 in the axial direction, a first internal thread is formed on the inner side wall of the proximal end of the transmission member 84, a second internal thread is formed on the inner side wall of the distal end of the transmission member 84, the proximal end of the transmission member 84 and the proximal end of the first adjusting member 6 are matched and connected through the first external thread 81 and the first internal thread, the distal end of the transmission member 84 and the proximal end of the second adjusting member 7 are matched and connected through the second external thread 82 and the second internal thread, when the knob 83 rotates in the first direction in the direction of its own axis under the action of external force, the knob 83 drives the transmission member 84 to rotate in the third direction in the direction of its own axis, thereby driving the first adjusting member 6 to move towards the proximal end and the second adjusting member 7 to move towards the distal end, when the knob 83 rotates in the second direction in the direction of its own axis under the action of external force, the knob 83 drives the transmission member 84 to rotate in the fourth direction in the direction of its own axis, thereby driving the first adjusting member 6 to move towards the distal end and the second adjusting member 7 to move towards the proximal end, one of the first direction and the second direction is the clockwise direction, and the other is the counterclockwise direction, one of the third direction and the fourth direction is the clockwise direction, and the other is the counterclockwise direction.

[0060] More specifically, in this embodiment, the first adjusting member 6 and the second adjusting member 7 are respectively made of high-toughness hollow thin tubes of 204 stainless steel. In this embodiment, the first external thread 81 and the second external thread 82 have the same pitch. The adjusting method of the balloon dilatation catheter of this embodiment is as follows:

[0061] When the thumb pushes the thumbwheel 83 forward to rotate, the distal end of the balloon skeleton 3 moves proximally and the proximal end of the balloon skeleton 3 moves distally, and as the distance between the distal end of the balloon skeleton 3 and the proximal end of the balloon skeleton 3 decreases, the C-shaped opening of the balloon body 4 expands and the radial direction of the balloon body 4 expands.

[0062] When the thumb pushes the thumbwheel 83 backward to rotate, the distal end of the balloon skeleton 3 moves distally and the proximal end of the balloon skeleton 3 moves proximally, and as the distance between the distal end of the balloon skeleton 3 and the proximal end of the balloon skeleton 3 increases, the C-shaped opening of the balloon body 4 shrinks and the radial direction of the balloon body 4 shrinks.

[0063] In this embodiment, the inner diameter of the balloon body 4 remains unchanged from the distal end to the proximal end of the balloon body 4.

[0064] Embodiment 2

[0065] This embodiment is another embodiment of the balloon dilatation catheter of the present application, which is basically the same as Embodiment 1, except that the pitch of the first external thread 81 is smaller than the pitch of the second external thread 82. The adjusting method of the balloon dilatation catheter of this embodiment is the same as Embodiment 1, and in the process of adjustment, in the axial direction of the balloon body 4, the inner diameter of the balloon body 4 will change to a certain extent: as shown in the figure, when the thumb pushes the thumbwheel 83 forward to rotate, the distal end of the balloon skeleton 3 moves proximally and the proximal end of the balloon skeleton 3 moves distally, and as the distance between the distal end of the balloon skeleton 3 and the proximal end of the balloon skeleton 3 decreases, the C-shaped opening of the balloon body 4 expands and the radial direction of the balloon body 4 expands, but the degree of diameter change of the distal end of the balloon skeleton 3 is smaller than that of the proximal end, so that the degree of expansion of the C-shaped opening of the distal end of the balloon body 4 is smaller than that of the proximal end of the balloon body 4, and the inner diameter of the balloon body 4 gradually decreases from the proximal end to the distal end of the balloon body 4. Figures 8-10

[0066] The balloon dilatation catheters of the above embodiments are adjusted after the balloon body 4 is inflated, and are inserted into the human body after the balloon body 4 is deflated and the balloon skeleton 3 is radially contracted.

[0067] The above only describes the preferred embodiments of the present application and is not intended to limit the present application. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.​

Claims

1. A balloon dilatation catheter characterized by: The balloon dilatation catheter comprises: an operating handle (1), a catheter (2) having a first lumen (21) for a guide wire and a second lumen (22) for gas or liquid, the operating handle (1) being arranged at a proximal end of the catheter (2); a balloon skeleton (3) capable of radial expansion or radial contraction, the balloon skeleton (3) being sleeved on an outer periphery of a distal end of the catheter (2) in an axial direction, a proximal end of the balloon skeleton (3) and a distal end of the balloon skeleton (3) being capable of sliding along the catheter (2) in the axial direction, respectively; a balloon body (4) having a compliance of ≤5%, the balloon body (4) being clamped and sleeved on an outside of the balloon skeleton (3) in the axial direction, a cross section of the balloon body (4) being C-shaped, the balloon body (4) being provided with a balloon body filling pipe (41) for connecting an inside of the balloon body (4) and the second lumen (22); a clamping assembly arranged between the balloon skeleton (3) and the balloon body (4) for connecting the balloon skeleton (3) and the balloon body (4); a first adjusting member (6) fixedly connected with the distal end of the balloon skeleton (3) and slidably connected with the proximal end of the balloon skeleton (3); a second adjusting member (7) fixedly connected with the proximal end of the balloon skeleton (3); an adjusting and locking mechanism capable of adjusting and locking a relative position between the proximal end of the balloon skeleton (3) and the distal end of the balloon skeleton (3); when the first adjusting member (6) is moved proximally and / or the second adjusting member (7) is moved distally, a distance between the proximal end and the distal end of the balloon skeleton (3) is reduced, the balloon skeleton (3) is expanded in the radial direction, and then the C-shaped opening of the balloon body (4) is expanded, and the balloon body (4) is expanded in the radial direction, when the first adjusting member (6) is moved distally and / or the second adjusting member (7) is moved proximally, the distance between the proximal end and the distal end of the balloon skeleton (3) is increased, the balloon skeleton (3) is contracted in the radial direction, and then the C-shaped opening of the balloon body (4) is reduced, and the balloon body (4) is contracted in the radial direction.

2. The balloon dilation catheter of claim 1, wherein: The side wall of the balloon body (4) near the balloon skeleton (3) is provided with a filling opening, one end of the balloon body filling pipe (41) is connected with the filling opening, the other end of the balloon body filling pipe (41) penetrates through the balloon skeleton (3) and is connected with the second lumen (22), and the balloon body filling pipe (41) is provided with a reserved wrinkle.

3. The balloon dilation catheter of claim 2, wherein: The clamping assembly comprises a guide rail fixedly arranged on the side wall of the balloon body (4) near the balloon skeleton (3) in the axial direction and a sliding block fixedly arranged on the balloon skeleton (3) and capable of being slidably connected with the guide rail.

4. The balloon dilation catheter of claim 3, wherein: The sliding block comprises a plurality of sliding blocks distributed in the axial direction, and / or the guide rail is made of stainless steel, and / or the guide rail is provided with a groove-shaped slide way extending from the proximal end to the distal end, the sliding block is located in the groove-shaped slide way, and the groove-shaped slide way is made of a visible high polymer material.

5. The balloon dilation catheter of claim 3, wherein: The guide rail comprises a first guide rail (51) and a second guide rail (52), the first guide rail (51) extends from the distal end of the capsule (4) to the middle part of the capsule (4), the second guide rail (52) extends from the proximal end of the capsule (4) to the middle part of the capsule (4), and there is a distance between the proximal end of the first guide rail (51) and the distal end of the second guide rail (52), and the slider comprises a slider capable of being slidably connected with the first guide rail (51) and a slider capable of being slidably connected with the second guide rail (52).

6. The balloon dilation catheter of claim 5, wherein: The clamping assembly and the catheter (2) are provided with a mesh basket (53), the mesh basket (53) is a hollow structure with two open ends, one end of the mesh basket (53) is fixedly connected with the proximal end of the first guide rail (51) and the distal end of the second guide rail (52) on both sides, and the other end is fixedly connected with the catheter (2), and the capsule filling pipeline (41) is arranged in the mesh basket (53).

7. The balloon dilation catheter of claim 6, wherein: The capsule filling pipeline (41) is in the shape of a funnel with an open end, and the open end is in communication with the filling port; And / or, the mesh basket (53) is in the shape of a funnel with an open end, and the open end is connected with the first guide rail (51) and the second guide rail (52); And / or, the mesh basket (53) is made of flexible material.

8. The balloon dilation catheter of any of claims 1-7, wherein: The first adjusting member (6) is a hollow tubular structure, which is slidably sleeved on the catheter (2) in the axial direction, the balloon skeleton (3) is sleeved on the outside of the first adjusting member (6) in the axial direction, and the distal end of the balloon skeleton (3) is fixedly connected with the distal end of the first adjusting member (6), a strip-shaped groove (61) extending in the axial direction is formed in the part of the first adjusting member (6) in the balloon skeleton (3), and the capsule filling pipeline (41) passes through the balloon skeleton (3) and the strip-shaped groove (61) to communicate with the second lumen (22); The second adjusting member (7) is a hollow tubular structure, which is slidably sleeved on the first adjusting member (6) in the axial direction, and the distal end of the second adjusting member (7) is fixedly connected with the proximal end of the balloon skeleton (3).

9. The balloon dilation catheter of claim 8, wherein: The adjusting and locking mechanism comprises a first matching part arranged on the first adjusting member (6), a second matching part arranged on the second adjusting member (7), and a third matching part arranged on the operating handle (1) and capable of matching with the first matching part and the second matching part respectively.

10. The balloon dilation catheter of claim 9, wherein: The operating handle (1) is provided with a receiving cavity, the first adjusting member (6) and the second adjusting member (7) extend into the receiving cavity respectively, The first matching part is a first external thread (81) formed on the outer side wall of the proximal end of the first adjusting member (6), the second matching part is a second external thread (82) formed on the outer side wall of the proximal end of the second adjusting member (7), the screw directions of the first external thread (81) and the second external thread (82) are opposite, the pitches of the first external thread (81) and the second external thread (82) are the same or different, The third matching part comprises a dial wheel (83) and a transmission member (84), the dial wheel (83) is rotatably arranged on the operation handle (1) along the direction of its own axis and partially located in the accommodating cavity, the transmission member (84) is in meshing connection with the dial wheel (83), the transmission member (84) is rotatably arranged in the accommodating cavity along the direction of its own axis, the transmission member (84) is axially sleeved on the second adjusting member (7), a first internal thread is formed on the inner side wall of the proximal end of the transmission member (84), a second internal thread is formed on the inner side wall of the distal end of the transmission member (84), the proximal end of the transmission member (84) and the proximal end of the first adjusting member (6) are in matching connection through the first external thread (81) and the first internal thread, the distal end of the transmission member (84) and the proximal end of the second adjusting member (7) are in matching connection through the second external thread (82) and the second internal thread, when the dial wheel (83) rotates along the direction of its own axis in a first direction under the action of external force, the dial wheel (83) drives the transmission member (84) to rotate along the direction of its own axis in a third direction, thereby driving the first adjusting member (6) to move towards the proximal end and the second adjusting member (7) to move towards the distal end, when the dial wheel (83) rotates along the direction of its own axis in a second direction under the action of external force, the dial wheel (83) drives the transmission member (84) to rotate along the direction of its own axis in a fourth direction, thereby driving the first adjusting member (6) to move towards the distal end and the second adjusting member (7) to move towards the proximal end, one of the first direction and the second direction is clockwise, and the other is counterclockwise, one of the third direction and the fourth direction is clockwise, and the other is counterclockwise.

11. The balloon dilation catheter of claim 1, wherein: The balloon skeleton (3) has a plurality of mesh structures connected in sequence along the axial direction and the circumferential direction, respectively; and / or, the distal end of the balloon skeleton (3) is provided with a first ring (31) which is radially invariable, and the proximal end of the balloon skeleton (3) is provided with a second ring (32) which is radially invariable; and / or, the balloon skeleton (3) is made of silk or cut from a hollow tube; and / or, the outer surface of the balloon body (4) and the balloon inflation channel is covered with a braided layer; and / or, the balloon body (4) and the balloon inflation channel are integrally formed; and / or, the outer surface of the balloon body (4) is coated with a hydrophilic coating; and / or, the material of the balloon body (4) is a high polymer material; and / or, the material of the balloon skeleton (3) is a high polymer material which is visible; and / or, the operation handle (1) is provided with a first access (11) which is in communication with the first cavity (21) and a second access (12) which is in communication with the second cavity (22).

12. The balloon dilation catheter of claim 1, wherein: The balloon dilatation catheter further comprises a catheter sheath which is sleeved outside the catheter (2) and the balloon body (4).

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