CN118526696B - A balloon dilatation catheter - Google Patents

A balloon dilatation catheter

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Publication number
CN118526696B
CN118526696B CN202410661301.2A CN202410661301A CN118526696B CN 118526696 B CN118526696 B CN 118526696B CN 202410661301 A CN202410661301 A CN 202410661301A CN 118526696 B CN118526696 B CN 118526696B
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CN
China
Prior art keywords
balloon
skeleton
proximal end
adjusting member
distal end
Prior art date
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Active
Application number
CN202410661301.2A
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Chinese (zh)
Other versions
CN118526696A (en
Inventor
赵迎红
周少华
王亮
陆剑峰
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Polyrey Medical Tech Suzhou Co ltd
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Polyrey Medical Tech Suzhou Co ltd
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Application filed by Polyrey Medical Tech Suzhou Co ltd filed Critical Polyrey Medical Tech Suzhou Co ltd
Priority to CN202410661301.2A priority Critical patent/CN118526696B/en
Publication of CN118526696A publication Critical patent/CN118526696A/en
Application granted granted Critical
Publication of CN118526696B publication Critical patent/CN118526696B/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1018Balloon inflating or inflation-control devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1002Balloon catheters characterised by balloon shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1002Balloon catheters characterised by balloon shape
    • A61M2025/1004Balloons with folds, e.g. folded or multifolded

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

本发明涉及一种球囊扩张导管,其包括操作手柄、导管、球囊骨架、囊体、第一调节件、第二调节件和调节锁定机构。操作手柄设置在导管的近端,球囊骨架沿轴向套设在导管远端,囊体沿轴向卡接套设在球囊骨架外部且横截面为C型,调节锁定机构能够调节并锁定球囊骨架近端和远端之间的相对位置。使第一调节件向近端移动和/或使第二调节件向远端移动时,球囊骨架近端和远端之间的距离缩小,球囊骨架径向扩张,囊体C型开口扩大,囊体径向扩大;使第一调节件向远端移动和/或第二调节件向近端移动时,球囊骨架近端和远端之间的距离增大,球囊骨架径向收缩,囊体C型开口缩小,囊体径向缩小。本发明的球囊扩张导管具有更好的稳定性,能灵活调整扩张程度。

The present invention relates to a balloon dilatation catheter, which includes an operating handle, a catheter, a balloon skeleton, a balloon body, a first adjusting member, a second adjusting member, and an adjusting locking mechanism. The operating handle is arranged at the proximal end of the catheter, the balloon skeleton is axially sleeved on the distal end of the catheter, the balloon body is axially clamped and sleeved on the outside of the balloon skeleton and has a C-shaped cross-section, and the adjusting locking mechanism can adjust and lock the relative position between the proximal and distal ends of the balloon skeleton. When the first adjusting member is moved proximally and/or the second adjusting member is moved distally, the distance between the proximal and distal ends of the balloon skeleton is reduced, the balloon skeleton is radially expanded, the C-shaped opening of the balloon body is expanded, and the balloon body is radially expanded; when the first adjusting member is moved distally and/or the second adjusting member is moved proximally, the distance between the proximal and distal ends of the balloon skeleton is increased, the balloon skeleton is radially contracted, the C-shaped opening of the balloon body is reduced, and the balloon body is radially reduced. The balloon dilatation catheter of the present invention has better stability and can flexibly adjust the degree of expansion.

Description

Balloon dilation catheter
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a balloon dilation catheter.
Background
The balloon dilation catheter can be used as a medical intervention instrument for dilating a narrow cavity organ in a human body under the influence of guidance, such as treating thrombus blockage in peripheral blood vessels, dredging blood vessels, dilating blood vessel channels, and widening the cavity pipelines in the human body such as sinuses, intestines and stomach, urethra and the like. The balloon dilation catheter is a soft catheter with an inflatable balloon at the head end, and can be retracted after successful treatment to withdraw the balloon catheter outside the body under the condition that the balloon catheter enters the target lesion. The most common on the market at present is a liquid filled balloon dilation catheter, which performs balloon dilation by inputting liquid into a balloon, wherein the liquid can be a mixed liquid of sterile injection and contrast liquid. The liquid filled balloon dilation catheter is widely applied in the interventional vasodilation field. However, in some application situations, the liquid-filled balloon has the problems of poor stability after expansion and incapability of flexibly adjusting the expansion degree and the form after expansion at any time, so that the dredging or expansion effect is not ideal.
Disclosure of Invention
The invention aims to provide a balloon dilation catheter which has good stability after balloon dilation and can flexibly adjust the degree of balloon dilation.
In order to achieve the above purpose, the invention adopts the following technical scheme:
A balloon dilation catheter comprising an operating handle; a catheter having a first lumen for passage of a guidewire and a second lumen for passage of a gas or liquid, the operating handle being disposed at a proximal end of the catheter; the balloon framework can be radially expanded or contracted, the balloon framework is axially sleeved on the periphery of the far end of the catheter, the near end of the balloon framework and the far end of the balloon framework can respectively slide along the axial direction of the catheter, the compliance of the balloon framework is less than or equal to 5 percent, the balloon framework is axially clamped and sleeved outside the balloon framework, the cross section of the balloon framework is C-shaped, the balloon framework is provided with a balloon filling pipeline for communicating the inside of the balloon framework and the second cavity, the clamping assembly is arranged between the balloon framework and used for connecting the balloon framework and the balloon framework, a first adjusting piece is fixedly connected with the far end of the balloon framework and is in sliding connection with the near end of the balloon framework, a second adjusting piece is fixedly connected with the near end of the balloon framework, an adjusting locking mechanism can adjust and lock the balloon framework, the position between the balloon framework and the near end of the balloon framework is enlarged along with the radial direction of the balloon framework, the distance between the second adjusting piece and the near end of the balloon framework is enlarged along with the radial direction or the far end of the balloon framework is enlarged along with the radial direction of the second adjusting piece, the distance between the near end of the balloon framework is enlarged along with the near end of the balloon framework or the near end is enlarged along with the radial direction of the near end of the balloon framework or the near end of the balloon framework is enlarged, the radial direction of the sacculus skeleton is contracted along with the sacculus skeleton, and then the C-shaped opening of the sacculus body is contracted along with the sacculus skeleton, and the radial direction of the sacculus body is contracted along with the sacculus body.
Preferably, a filling port is formed in a side wall, close to the balloon skeleton, of the balloon body, one end of the balloon body filling pipeline is communicated with the filling port, the other end of the balloon body filling pipeline penetrates through the balloon skeleton and is communicated with the second cavity, and reserved folds are formed in the balloon body filling pipeline. The design of reserved folds enables the balloon body filling pipeline to have a pulling allowance when the C-shaped balloon expands radially.
Preferably, the clamping assembly comprises a guide rail fixedly arranged on the side wall of the balloon body, which is close to the balloon skeleton, along the axial direction, and a sliding block fixedly arranged on the balloon skeleton and capable of being in sliding connection with the guide rail.
Further preferably, the slider comprises a plurality of axially spaced apart sliders.
Further preferably, the guide rail is made of stainless steel, for example 304 stainless steel.
Further preferably, the guide rail is provided with a groove-shaped slideway, the sliding block is positioned in the groove-shaped slideway, and the groove-shaped slideway is made of a developable polymer material. For example, the material of the groove-shaped slideway can be a silicon rubber material added with contrast agents such as iodine or barium, so that the groove-shaped slideway has good developing effect under rays, excellent biocompatibility and flexibility, and good sliding effect in the balloon skeleton deformation process.
According to a specific and preferred embodiment, the guide rail comprises a first guide rail and a second guide rail, the first guide rail extends from the distal end of the capsule to the middle of the capsule, the second guide rail extends along the proximal end of the capsule to the middle of the capsule, a distance exists between the proximal end of the first guide rail and the distal end of the second guide rail, and the slide block comprises a slide block capable of being slidingly connected with the first guide rail and a slide block capable of being slidingly connected with the second guide rail.
Further, a basket is arranged between the clamping assembly and the guide pipe, the basket is of a hollow structure with two open ends, two sides of one end of the basket being open are respectively fixedly connected with the proximal end of the first guide rail and the distal end of the second guide rail, the other end of the basket is open and fixedly connected with the guide pipe, and the capsule filling pipeline is arranged in the basket in a penetrating mode.
Still further, the bladder filling duct is funnel-shaped with an opening and the opening is in communication with the filling opening.
Further, the basket is funnel-shaped with an opening and the opening is connected with the first guide rail and the second guide rail.
Further, the basket is made of flexible materials, such as silica gel.
According to a specific and preferred embodiment, the first adjusting member is of a hollow tubular structure and is axially slidably sleeved on the catheter, the balloon skeleton is axially sleeved outside the first adjusting member, the distal end of the balloon skeleton is fixedly connected with the distal end of the first adjusting member, a strip-shaped groove extending along the axial direction is formed in the portion, located in the balloon skeleton, of the first adjusting member, the balloon filling pipeline penetrates through the balloon skeleton and the strip-shaped groove to be communicated with the second cavity, the second adjusting member is of a hollow tubular structure and is axially slidably sleeved on the first adjusting member, and the distal end of the second adjusting member is fixedly connected with the proximal end of the balloon skeleton.
Preferably, the adjusting and locking mechanism comprises a first matching part arranged on the first adjusting piece, a second matching part arranged on the second adjusting piece, and a third matching part arranged on the operating handle and capable of being respectively matched with the first matching part and the second matching part.
Preferably, the adjusting and locking mechanism comprises a first matching part arranged on the first adjusting piece, a second matching part arranged on the second adjusting piece, and a third matching part arranged on the operating handle and capable of being respectively matched with the first matching part and the second matching part.
According to some specific and preferred embodiments, the operating handle is provided with a containing cavity, the first adjusting member and the second adjusting member respectively extend into the containing cavity, the first matching part is a first external thread formed on the outer side wall of the proximal end of the first adjusting member, the second matching part is a second external thread formed on the outer side wall of the proximal end of the second adjusting member, the spiral directions of the first external thread and the second external thread are opposite, the pitch of the first external thread and the pitch of the second external thread are the same or different, the third matching part comprises a dial wheel and a transmission member, the dial wheel is rotatably arranged on the operating handle in the containing cavity in a part of the dial wheel around the self axis direction, the transmission member is rotatably arranged in the containing cavity around the self axis direction, the transmission member is axially sleeved on the second adjusting member, the inner side wall of the proximal end of the transmission member is provided with a first internal thread, the transmission member is rotatably arranged on the inner side wall of the proximal end of the transmission member in the second adjusting member, when the first external thread and the second external thread is in the second direction, the second matching part of the transmission member is rotatably arranged on the second adjusting member around the second external thread around the self axis direction, the second external thread is rotatably connected with the second external thread around the second external thread, and the second external thread is further connected with the second external thread around the second external thread, and the second external thread is in the second direction, and the second external thread is meshed with the dial wheel in the second direction, and the second external thread when the second external thread is rotatably around the second external thread and rotates part and the second external thread and rotates around the second external thread and the second member, the driving wheel drives the transmission piece to rotate around the axis direction of the driving wheel along a fourth direction, so that the first adjusting piece is driven to move towards the far end and the second adjusting piece is driven to move towards the near end, one of the first direction and the second direction is clockwise, the other is anticlockwise, one of the third direction and the fourth direction is clockwise, and the other is anticlockwise.
Preferably, the balloon skeleton is provided with a plurality of mesh structures which are sequentially connected along the axial direction and the circumferential direction.
Preferably, the distal end of the balloon skeleton is provided with a radially non-variable first ring, and the proximal end of the balloon skeleton is provided with a radially non-variable second ring.
Preferably, the balloon skeleton is woven from wires or cut from hollow tubes.
Preferably, the outer surfaces of the balloon body and the balloon filling channel are covered with a braiding layer, so that the compliance of the balloon body can be further reduced.
Preferably, the balloon is integrally formed with the balloon inflation channel.
Preferably, the outer surface of the capsule is coated with a hydrophilic coating.
Preferably, the material of the capsule body is a polymer material.
Preferably, the balloon skeleton is made of a developable polymer material.
According to some embodiments, the operating handle is provided with a first inlet and a second inlet which are communicated with the first cavity and the second cavity.
Preferably, the balloon dilation catheter further comprises a catheter sheath sleeved outside the catheter and the balloon body. The balloon dilation catheter of the present invention is suitable for use with conventional sized sheaths, preferably 3-8F inner diameter sheaths. The actual application is selected according to the size of the lesion body pipeline.
Due to the application of the technical scheme, compared with the prior art, the invention has the following advantages:
The balloon dilation catheter has better stability after balloon dilation, and can flexibly adjust the balloon dilation degree so as to improve dredging and dilation effects. The balloon dilation catheter can be held by one hand and operated by thumb, and is convenient, quick and flexible.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for the description of the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic view showing the structure of a balloon dilation catheter of example 1 in a balloon radially-expanded state;
FIG. 2 is a schematic view (partially cut-away) of the balloon dilation catheter of example 1 in a balloon radially-expanded state;
FIG. 3 is an enlarged view of FIG. 2 at A;
FIG. 4 is a schematic view showing a part of the balloon skeleton of the balloon dilation catheter of example 1 and a part of the catheter (the balloon skeleton is in a radially contracted state);
FIG. 5 is a schematic structural view of the balloon body of the balloon dilation catheter of example 1;
FIG. 6 is a schematic cross-sectional view of the balloon inflation conduit of the balloon dilation catheter of example 1;
FIG. 7 is a schematic cross-sectional view of the balloon dilation catheter of example 1 in a radially expanded state of the balloon (with the balloon skeleton removed);
FIG. 8 is a schematic view showing the structure of a balloon dilation catheter of example 2 in a balloon radially-expanded state;
FIG. 9 is a schematic view showing a partial structure of the balloon dilation catheter of example 2 in a balloon radially-expanded state (with the operating handle omitted);
Figure 10 is a schematic view showing the partial structure of the balloon dilation catheter of example 2 in a balloon radially expanded state (with the operating handle and balloon removed),
In the figures, 1, an operating handle, 11, a first inlet and outlet, 12, a second inlet and outlet, 2, a catheter, 21, a first cavity, 22, a second cavity, 3, a balloon skeleton, 31, a first ring, 32, a second ring, 4, a balloon body, 41, a balloon filling pipeline, 51, a first guide rail, 52, a second guide rail, 53, a basket, 6, a first adjusting piece, 61, a strip-shaped groove, 7, a second adjusting piece, 81, a first external thread, 82, a second external thread, 83, a deflector wheel, 84 and a transmission piece.
Detailed Description
Hereinafter, only certain exemplary embodiments are briefly described. As will be recognized by those of skill in the pertinent art, the described embodiments may be modified in numerous different ways without departing from the spirit or scope of the embodiments of the present invention. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.
In the description of the present invention, it will be understood that distal refers to the end of the instrument or component that is distal from the operator, proximal refers to the end of the instrument or component that is proximal to the operator, axial refers to the direction parallel to the line connecting the distal end of the instrument or component to the center of the proximal end, and radial refers to the direction perpendicular to the axial, and inner and outer refer to positions defined by the distance from the center of the instrument or component, wherein inner is the position proximal to the center of the instrument or component and outer is the position distal from the center of the instrument or component. The above description of orientation words is merely for convenience in describing embodiments of the present invention and for simplicity of description, and does not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operate in a particular orientation, and therefore should not be construed as limiting embodiments of the present invention.
In the description of the present invention, unless explicitly stated and limited otherwise, the terms "coupled," "affixed," and the like are to be construed broadly, and may be, for example, fixedly coupled, detachably coupled, or integrally formed. The specific meaning of the above terms in the embodiments of the present invention will be understood by those of ordinary skill in the art according to specific circumstances.
In the description of the present invention, plural means two or more.
In the invention, the calculation method of the compliance is that the compliance is = { (diameter @ rated burst pressure-diameter @ nominal pressure)/(rated burst pressure-nominal pressure) } ×100%, the nominal pressure is the pressure born by the balloon in normal operation, and the rated burst pressure is the maximum pressure born by the balloon at the moment of rupture.
Embodiments of the present invention will be described in detail below with reference to the accompanying drawings.
Example 1
The embodiment is an implementation manner of the balloon dilation catheter of the present invention, and specifically as shown in fig. 1 to 7, the balloon dilation catheter comprises an operation handle 1, a catheter 2, a balloon skeleton 3, a balloon body 4, a clamping assembly, a first adjusting piece 6, a second adjusting piece 7 and an adjusting locking mechanism.
In particular, the catheter 2 has a first lumen 21 for passage of a guidewire and a second lumen 22 for passage of a 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 distally from the proximal end of the catheter 2 but does not reach the distal end, i.e. the distal end of the second lumen 22 is blocked. In this embodiment, the cross section of the first channel 21 is circular, and the cross section of the second channel 22 is crescent-shaped. In this embodiment, the first lumen 21 may be through a guidewire having a size of 0.035 inches or less.
Specifically, the operating handle 1 is sleeved on the proximal end of the catheter 2, a containing cavity is arranged in the operating handle 1, and a first inlet and outlet 11 communicated with the first cavity channel 21 and a second inlet and outlet 12 communicated with the second cavity channel 22 are arranged on the operating handle 1.
Specifically, the balloon skeleton 3 can radially expand or radially contract, the balloon skeleton 3 is axially sleeved on the outer periphery of the distal end of the catheter 2, and the proximal end of the balloon skeleton 3 and the distal end of the balloon skeleton 3 can respectively slide along the axial direction of the catheter 2. In this embodiment, the balloon skeleton 3 has a plurality of mesh structures sequentially connected along the axial direction and the circumferential direction, the distal end of the balloon skeleton 3 is provided with a radially invariable first ring 31, the proximal end of the balloon skeleton 3 is provided with a radially invariable second ring 32, and the balloon skeleton 3 is made of a PEEK material (TECAPEEK MT XRO GREEN) which is visible by X-rays and conforms to biocompatibility.
Specifically, the compliance of the balloon body 4 is less than or equal to 5%, the balloon body 4 is sleeved outside the balloon skeleton 3 in an axial clamping manner, the cross section of the balloon body 4 is C-shaped, and the balloon body 4 is provided with a balloon body filling pipeline 41 for communicating the inside of the balloon body 4 with the second cavity 22. In this embodiment, a filling port is formed on a side wall of the balloon body 4, which is close to the balloon skeleton 3, one end of the balloon body filling pipeline 41 is funnel-shaped with an opening, the opening is communicated with the filling port, the other end passes through the balloon skeleton 3 and the second cavity 22, and the balloon body filling pipeline 41 is provided with reserved folds through laser welding. The bag body 4 is made of PEBAX material, the bag body 4 and the bag body filling pipeline 41 are integrally formed under blow molding, the formed flat bag body is subjected to C-shaped bending deformation, shaping is carried out at high temperature, the outer side surface of the bag body 4 is coated with a hydrophilic coating, ultraviolet rays are used for curing, a PET (polyethylene terephthalate) braiding wire is used for covering the outer surface with a braiding layer (comprising the bag body filling pipeline), the appearance of the bag body 4 after the braiding layer is reinforced is more stable, the flexibility performance is good, and the compliance can be reduced to within 5%. The above processes are conventional in the art and are not described herein.
Specifically, the clamping assembly is arranged between the balloon framework 3 and the balloon body 4 and is used for connecting the balloon framework 3 and the balloon body 4. In this embodiment, the clamping assembly includes a rail, a slider, and a basket 53. The guide rail is fixedly arranged on one side wall of the balloon body 4, which is close to the balloon skeleton 3, along the axial direction, and comprises a first guide rail 51 and a second guide rail 52, wherein the first guide rail 51 extends from the distal end of the balloon body 4 to the middle part of the balloon body 4, the second guide rail 52 extends from the proximal end of the balloon body 4 to the middle part of the balloon body 4, and a distance exists 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 adhered to two opposite sides of the filling opening of the bag body 4 through glue. The first guide rail 51 and the second guide rail 52 are both provided with a groove-shaped slideway extending from the proximal end to the distal end, and the groove-shaped slideway is made of silicon rubber added with contrast agent. The sliding blocks comprise a plurality of sliding blocks which are distributed at intervals along the axial direction, a plurality of sliding blocks are connected in the groove-shaped sliding way of the first guide rail 51 and the groove-shaped sliding way of the second guide rail 52 in a sliding manner, the sliding blocks in the embodiment are outwards-protruding balls fixedly arranged at the top points of meshes, and a good sliding effect is achieved when the sliding blocks are embedded into the groove channels. The basket 53 is a hollow structure with two open ends, two open sides of one end of the basket are respectively and fixedly connected with the proximal end of the first guide rail 51 and the distal end of the second guide rail 52, the other end of the basket is fixedly connected with the catheter 2, and the capsule filling pipeline 41 is arranged in the basket 53 in a penetrating way. The basket 53 is welded to the catheter 2, the first rail and the second rail, respectively, so that they can be formed as a single body, and the single body is hardly displaced in the axial direction when the balloon frame 3 is deformed. The basket 53 is shaped like an open funnel, one side of which is connected to the proximal end of the first rail 51, and the other side is connected to the distal end of the second rail 52, and the basket 53 is made of a flexible material and can be pulled and deformed.
Specifically, the first adjusting member 6 is fixedly connected with the distal end of the balloon skeleton 3, and is slidably connected with the proximal end of the balloon skeleton 3. The second adjusting piece 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 frame 3 and the distal end of the balloon frame 3, and comprises a first matching part arranged on the first adjusting piece 6, a second matching part arranged on the second adjusting piece 7, and a third matching part arranged on the operating handle 1 and respectively matched with the first matching part and the second matching part, when the first adjusting piece 6 moves proximally and the second adjusting piece 7 moves distally, the distance between the proximal end and the distal end of the balloon frame 3 is reduced, the radial direction of the balloon frame 3 is expanded, the C-shaped opening of the balloon body 4 is further expanded, the radial direction of the balloon body 4 is further expanded, the distance between the proximal end and the distal end of the balloon frame 3 is further increased when the first adjusting piece 6 moves distally and the second adjusting piece 7 moves proximally, the radial direction of the balloon frame 3 is further contracted, and the C-shaped opening of the balloon body 4 is further contracted.
In this embodiment, the first adjusting member 6 is a hollow tubular structure, and is axially slidably sleeved on the catheter 2, the balloon skeleton 3 is axially sleeved outside the first adjusting member 6, 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 along the axial direction is formed in the portion, located in the balloon skeleton 3, of the first adjusting member 6, the balloon filling pipe 41 passes through the balloon skeleton 3 and the strip-shaped groove 61 to be communicated with the second cavity 22, the basket 53 passes through the balloon skeleton 3 and the strip-shaped groove 61 to be connected with the strip-shaped groove 61 and the outer wall of the catheter 2, the second adjusting member 7 is a hollow tubular structure, and is axially slidably sleeved on the first adjusting member 6, and the distal end of the second adjusting member 7 is fixedly connected with the proximal end of the balloon skeleton 3.
In this embodiment, the first adjusting member 6 and the second adjusting member 7 extend into the accommodating cavity respectively, the first matching portion 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 portion is a second external thread 82 formed on the outer side wall of the proximal end of the second adjusting member 7, the spiral directions of the first external thread 81 and the second external thread 82 are opposite, the pitch of the first external thread 81 is the same as or different from the pitch of the second external thread 82, the third matching portion comprises a dial wheel 83 and a transmission member 84, the dial wheel 83 is rotatably arranged on the operating handle 1 around the self axis direction and is partially positioned in the accommodating cavity, the transmission member 84 is engaged with the dial wheel 83, the transmission member 84 is rotatably arranged in the accommodating cavity around the self axis direction, 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 second external thread 84 are rotatably connected with the second external thread 84 around the second axis direction by the second external thread of the second adjusting member 6, when the proximal end of the transmission member 84 and the second external thread 84 are rotatably connected with the second external thread 84 around the second external thread of the second adjusting member 6 in the self-rotation direction, the second external thread is driven by the second external thread 84 around the second external thread of the second external thread 84, and the transmission member 84 is rotated around the second external thread 84 around the second external thread of the proximal end of the second external thread 84 and the proximal end of the second adjusting member 84, thereby driving the first regulating member 6 to move distally and the second regulating member 7 to move proximally, one of the first direction and the second direction being clockwise, the other being counterclockwise, one of the third direction and the fourth direction being clockwise, the other being counterclockwise.
More specifically, in the present embodiment, the first regulating member 6 and the second regulating member 7 are respectively formed of 204 stainless steel high-toughness hollow thin pipes. In this embodiment, the pitch of the first external thread 81 is the same as the pitch of the second external thread 82. The adjusting method of the balloon dilation catheter of the embodiment comprises the following steps:
When the thumb pushes the thumb wheel 83 forward to rotate, the distal end of the balloon frame 3 moves proximally and the proximal end of the balloon frame 3 moves distally, and as the distance between the distal end of the balloon frame 3 and the proximal end of the balloon frame 3 decreases, the C-shaped opening of the balloon 4 expands, and the radial direction of the balloon 4 expands.
When the thumb dial wheel 83 is rotated, the distal end of the balloon frame 3 moves distally and the proximal end of the balloon frame 3 moves proximally, and as the distance between the distal end of the balloon frame 3 and the proximal end of the balloon frame 3 increases, the C-shaped opening of the balloon 4 decreases, and the radial direction of the balloon 4 decreases.
In this embodiment, the inner diameter of the balloon 4 remains constant from the distal end of the balloon 4 to its proximal end.
Example 2
This example is another embodiment of the balloon dilation catheter of the present invention which is substantially identical to example 1 except that the pitch of the first external threads 81 is less than the pitch of the second external threads 82. In the balloon dilation catheter adjusting method of this embodiment, as shown in fig. 8-10, when the thumb pushes the thumb wheel 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, the C-shaped opening of the balloon body 4 expands with the reduction of the distance between the distal end of the balloon skeleton 3 and the proximal end of the balloon skeleton 3, the radial direction of the balloon body 4 expands with the expansion of the C-shaped opening of the balloon body 4, but the degree of diameter variation of the distal end of the balloon skeleton 3 is smaller than the degree of diameter variation 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 the degree of expansion of the C-shaped opening of the proximal end of the balloon body 4, and the inner diameter of the balloon body 4 gradually decreases from the proximal end of the balloon body 4 to the distal end thereof, as the axial direction of the balloon body 4 is adjusted.
The balloon dilation catheter of the above embodiment is adjusted after the balloon 4 is filled, and the balloon is decompressed by the balloon 4 and the balloon skeleton 3 is contracted radially to enter and exit the human body.
The above is only a preferred embodiment of the present invention, and is not intended to limit the present invention, but various modifications and variations can be made to the present invention by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (12)

1.一种球囊扩张导管,其特征在于:所述球囊扩张导管包括:1. A balloon dilatation catheter, characterized in that: the balloon dilatation catheter comprises: 操作手柄(1),Operating handle (1), 导管(2),所述导管(2)具有供导丝通过的第一腔道(21)和供气体或液体通过的第二腔道(22),所述操作手柄(1)设置在所述导管(2)的近端;A catheter (2), the catheter (2) having a first lumen (21) for a guide wire to pass through and a second lumen (22) for gas or liquid to pass through, the operating handle (1) being arranged at the proximal end of the catheter (2); 球囊骨架(3),其能够径向扩张或径向收缩,所述球囊骨架(3)沿轴向套设在所述导管(2)的远端外周,所述球囊骨架(3)的近端和所述球囊骨架(3)的远端分别能够沿所述导管(2)的轴向滑动;A balloon skeleton (3) capable of radial expansion or radial contraction, the balloon skeleton (3) being axially sleeved on the outer periphery of the distal end of the catheter (2), the proximal end of the balloon skeleton (3) and the distal end of the balloon skeleton (3) being respectively capable of sliding along the axial direction of the catheter (2); 囊体(4),其顺应性≤5%,所述囊体(4)沿轴向卡接套设在所述球囊骨架(3)的外部,所述囊体(4)的横截面为C型,所述囊体(4)上设有用于连通所述囊体(4)的内部和所述第二腔道(22)的囊体充盈管道(41);A capsule (4) having a compliance of ≤5%, the capsule (4) being axially snap-fitted onto the outside of the balloon frame (3), the capsule (4) having a C-shaped cross section, and a capsule filling conduit (41) for connecting the interior of the capsule (4) and the second cavity (22); 卡接组件,其设置在所述球囊骨架(3)和所述囊体(4)之间,用于连接所述球囊骨架(3)和所述囊体(4);A snap-fit assembly, which is arranged between the balloon frame (3) and the balloon body (4) and is used to connect the balloon frame (3) and the balloon body (4); 第一调节件(6),所述第一调节件(6)与所述球囊骨架(3)的远端相固定连接,与所述球囊骨架(3)的近端相滑动连接;A first adjusting member (6), wherein the first adjusting member (6) is fixedly connected to the distal end of the balloon frame (3) and is slidably connected to the proximal end of the balloon frame (3); 第二调节件(7),所述第二调节件(7)与所述球囊骨架(3)的近端相固定连接;a second adjusting member (7), the second adjusting member (7) being fixedly connected to the proximal end of the balloon frame (3); 调节锁定机构,其能够调节并锁定所述球囊骨架(3)的近端和所述球囊骨架(3)的远端之间的相对位置;An adjustment locking mechanism capable of adjusting and locking the relative position between the proximal end of the balloon skeleton (3) and the distal end of the balloon skeleton (3); 使所述第一调节件(6)向近端移动和/或使所述第二调节件(7)向远端移动时,所述球囊骨架(3)的近端和远端之间的距离缩小,所述球囊骨架(3)的径向随之扩张,进而所述囊体(4)的C型开口随之扩大,囊体(4)的径向随之扩大,When the first adjusting member (6) is moved toward the proximal end and/or the second adjusting member (7) is moved toward the distal end, the distance between the proximal end and the distal end of the balloon skeleton (3) is reduced, and the radial direction of the balloon skeleton (3) is expanded accordingly, and then the C-shaped opening of the balloon body (4) is expanded accordingly, and the radial direction of the balloon body (4) is expanded accordingly. 使所述第一调节件(6)向远端移动和/或所述第二调节件(7)向近端移动时,所述球囊骨架(3)的近端和远端之间的距离增大,所述球囊骨架(3)的径向随之收缩,进而所述囊体(4)的C型开口随之缩小,囊体(4)的径向随之缩小。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) increases, and the radial direction of the balloon skeleton (3) shrinks accordingly, and the C-shaped opening of the capsule body (4) shrinks accordingly, and the radial direction of the capsule body (4) shrinks accordingly. 2.根据权利要求1所述的球囊扩张导管,其特征在于:所述囊体(4)的靠近所述球囊骨架(3)的一侧侧壁上开设有充盈口,所述囊体充盈管道(41)的一端与所述充盈口相连通,另一端穿过所述球囊骨架(3)与所述第二腔道(22)相连通,所述囊体充盈管道(41)设有预留褶皱。2. The balloon dilatation catheter according to claim 1 is characterized in that: a filling port is opened on the side wall of the balloon body (4) close to the balloon skeleton (3), one end of the balloon filling channel (41) is connected to the filling port, and the other end passes through the balloon skeleton (3) and is connected to the second cavity (22), and the balloon filling channel (41) is provided with reserved folds. 3.根据权利要求2所述的球囊扩张导管,其特征在于:所述卡接组件包括沿轴向固定设置在所述囊体(4)的靠近所述球囊骨架(3)的一侧侧壁上的导轨、固定设置在所述球囊骨架(3)上的能够与所述导轨相滑动连接的滑块。3. The balloon dilatation catheter according to claim 2 is characterized in that: the clamping assembly includes a guide rail fixedly arranged axially on the side wall of the balloon body (4) close to the balloon skeleton (3), and a slider fixedly arranged on the balloon skeleton (3) and capable of being slidably connected to the guide rail. 4.根据权利要求3所述的球囊扩张导管,其特征在于:所述滑块包括沿轴向间隔分布的多个;和/或,所述导轨的材质为不锈钢;和/或,所述导轨设有自近端延伸至远端的槽型滑道,所述滑块位于所述槽型滑道中,所述槽型滑道的材质为可显影的高分子材料。4. The balloon dilatation catheter according to claim 3 is characterized in that: the slider includes a plurality of sliders distributed along the axial direction; and/or the guide rail is made of stainless steel; and/or the guide rail is provided with a grooved slide extending from the proximal end to the distal end, the slider is located in the grooved slide, and the grooved slide is made of a developable polymer material. 5.根据权利要求3所述的球囊扩张导管,其特征在于:所述导轨包括第一导轨(51)和第二导轨(52),所述第一导轨(51)自所述囊体(4)的远端延伸至所述囊体(4)的中部,所述第二导轨(52)沿所述囊体(4)的近端伸至所述囊体(4)的中部,且所述第一导轨(51)的近端和所述第二导轨(52)的远端之间存在一段距离,所述滑块包括能够与所述第一导轨(51)相滑动连接的滑块和能够与所述第二导轨(52)相滑动连接的滑块。5. The balloon dilatation catheter according to claim 3 is characterized in that: the guide rail 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 of the balloon body (4), the second guide rail (52) extends along the proximal end of the balloon body (4) to the middle of the balloon body (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 includes a slider that can be slidably connected to the first guide rail (51) and a slider that can be slidably connected to the second guide rail (52). 6.根据权利要求5所述的球囊扩张导管,其特征在于:所述卡接组件和所述导管(2)之间设有网篮(53),所述网篮(53)为两端开口的中空结构,其一端开口的两侧分别与所述第一导轨(51)的近端和所述第二导轨(52)的远端相固定连接,另一端开口与所述导管(2)相固定连接,所述囊体充盈管道(41)穿设于所述网篮(53)中。6. The balloon dilatation catheter according to claim 5 is characterized in that a mesh basket (53) is provided between the clamping assembly and the catheter (2), and the mesh basket (53) is a hollow structure with openings at both ends, and the two sides of the opening at one end are fixedly connected to the proximal end of the first guide rail (51) and the distal end of the second guide rail (52), respectively, and the opening at the other end is fixedly connected to the catheter (2), and the balloon filling pipe (41) is passed through the mesh basket (53). 7.根据权利要求6所述的球囊扩张导管,其特征在于:所述囊体充盈管道(41)呈具有敞口的漏斗形且其敞口与所述充盈口相连通;7. The balloon dilatation catheter according to claim 6, characterized in that: the balloon filling channel (41) is in the shape of a funnel with an open opening, and the open opening is connected to the filling port; 和/或,所述网篮(53)呈具有敞口的漏斗形且其敞口与所述第一导轨(51)和所述第二导轨(52)相连接;And/or, the net basket (53) is in the shape of a funnel with an open opening, and the open opening is connected to the first guide rail (51) and the second guide rail (52); 和/或,所述网篮(53)的材质为柔性材质。And/or, the material of the mesh basket (53) is a flexible material. 8.根据权利要求1至7中任一项所述的球囊扩张导管,其特征在于:所述第一调节件(6)为中空管状结构,其沿轴向可滑动地套设在所述导管(2)上,所述球囊骨架(3)沿轴向套设在所述第一调节件(6)的外部且所述球囊骨架(3)的远端与所述第一调节件(6)的远端相固定连接,所述第一调节件(6)的位于所述球囊骨架(3)中的部分上开设有沿轴向延伸的条形槽(61),所述囊体充盈管道(41)穿过所述球囊骨架(3)和所述条形槽(61)与所述第二腔道(22)相连通;8. The balloon dilatation catheter according to any one of claims 1 to 7, characterized in that: the first adjusting member (6) is a hollow tubular structure, which is slidably sleeved on the catheter (2) along the axial direction, the balloon skeleton (3) is axially sleeved on the outside of the first adjusting member (6) and the distal end of the balloon skeleton (3) is fixedly connected to the distal end of the first adjusting member (6), and the portion of the first adjusting member (6) located in the balloon skeleton (3) is provided with an axially extending strip groove (61), and the balloon filling channel (41) passes through the balloon skeleton (3) and the strip groove (61) to communicate with the second cavity (22); 所述第二调节件(7)为中空管状结构,其沿轴向可滑动地套设在所述第一调节件(6)上,所述第二调节件(7)的远端与所述球囊骨架(3)的近端相固定连接。The second adjusting member (7) is a hollow tubular structure, which is slidably sleeved on the first adjusting member (6) along the axial direction, and the distal end of the second adjusting member (7) is fixedly connected to the proximal end of the balloon skeleton (3). 9.根据权利要求8所述的球囊扩张导管,其特征在于:所述调节锁定机构包括设置在所述第一调节件(6)上的第一配合部、设置在所述第二调节件(7)上的第二配合部、设置在所述操作手柄(1)上的能够与所述第一配合部和所述第二配合部分别相配合的第三配合部。9. The balloon dilatation catheter according to claim 8 is characterized in that the adjustment locking mechanism includes a first matching portion provided on the first adjustment member (6), a second matching portion provided on the second adjustment member (7), and a third matching portion provided on the operating handle (1) and capable of matching with the first matching portion and the second matching portion respectively. 10.根据权利要求9所述的球囊扩张导管,其特征在于:所述操作手柄(1)设有容纳腔,第一调节件(6)和所述第二调节件(7)分别延伸至所述容纳腔中,10. The balloon dilatation catheter according to claim 9, characterized in that: the operating handle (1) is provided with a receiving cavity, the first adjusting member (6) and the second adjusting member (7) respectively extend into the receiving cavity, 所述第一配合部为开设在所述第一调节件(6)的近端的外侧壁上的第一外螺纹(81),所述第二配合部为开设在所述第二调节件(7)的近端的外侧壁上的第二外螺纹(82),所述第一外螺纹(81)和所述第二外螺纹(82)的螺旋方向相反,所述第一外螺纹(81)的螺距和所述第二外螺纹(82)的螺距相同或不同,The first matching portion is a first external thread (81) provided on the outer side wall of the proximal end of the first adjusting member (6), and the second matching portion is a second external thread (82) provided on the outer side wall of the proximal end of the second adjusting member (7). The spiral directions of the first external thread (81) and the second external thread (82) are opposite, and the pitch of the first external thread (81) and the pitch of the second external thread (82) are the same or different. 所述第三配合部包括拨轮(83)和传动件(84),所述拨轮(83)绕自身轴线方向可转动地设置在所述操作手柄(1)上且部分位于所述容纳腔中,所述传动件(84)与所述拨轮(83)相啮合连接,所述传动件(84)绕自身轴线方向可转动地设置在所述容纳腔中,所述传动件(84)沿轴向套设在所述第二调节件(7)上,所述传动件(84)的近端的内侧壁上开设有第一内螺纹,所述传动件(84)的远端的内侧壁上开设有第二内螺纹,所述传动件(84)的近端和所述第一调节件(6)的近端通过所述第一外螺纹(81)和所述第一内螺纹配合连接,所述传动件(84)的远端与所述第二调节件(7)的近端通过所述第二外螺纹(82)和所述第二内螺纹配合连接,The third matching portion includes a thumbwheel (83) and a transmission member (84), the thumbwheel (83) is rotatably arranged on the operating handle (1) around its own axis and is partially located in the accommodating cavity, the transmission member (84) is meshed with the thumbwheel (83), the transmission member (84) is rotatably arranged in the accommodating cavity around its own axis, the transmission member (84) is axially sleeved on the second adjusting member (7), a first internal thread is provided on the inner side wall of the proximal end of the transmission member (84), a second internal thread is provided 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 connected by 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 connected by the second external thread (82) and the second internal thread, 当所述拨轮(83)在外力作用下绕其自身轴线方向沿第一方向转动时,所述拨轮(83)带动所述传动件(84)绕自身轴线方向沿第三方向转动,进而驱动所述第一调节件(6)向近端移动和所述第二调节件(7)向远端移动,When the thumbwheel (83) rotates in a first direction around its own axis under the action of an external force, the thumbwheel (83) drives the transmission member (84) to rotate in a third direction around its own axis, thereby driving the first adjustment member (6) to move toward the proximal end and the second adjustment member (7) to move toward the distal end. 当所述拨轮(83)在外力作用下绕其自身轴线方向沿第二方向转动时,所述拨轮(83)带动所述传动件(84)绕自身轴线方向沿第四方向转动,进而驱动所述第一调节件(6)向远端移动和所述第二调节件(7)向近端移动,When the thumbwheel (83) rotates in the second direction around its own axis under the action of an external force, the thumbwheel (83) drives the transmission member (84) to rotate in the fourth direction around its own axis, thereby driving the first adjustment member (6) to move toward the distal end and the second adjustment member (7) to move toward the proximal end. 所述第一方向和所述第二方向中的一者为顺时针方向,另一者为逆时针方向,所述第三方向和所述第四方向中的一者为顺时针方向,另一者为逆时针方向。One of the first direction and the second direction is a clockwise direction, and the other is a counterclockwise direction. One of the third direction and the fourth direction is a clockwise direction, and the other is a counterclockwise direction. 11.根据权利要求1所述的球囊扩张导管,其特征在于:所述球囊骨架(3)沿轴向和周向分别具有多个依次相连的网孔结构;11. The balloon dilatation catheter according to claim 1, characterized in that: the balloon skeleton (3) has a plurality of mesh structures connected in sequence along the axial direction and the circumferential direction respectively; 和/或,所述球囊骨架(3)的远端设有径向不可变的第一环(31),所述球囊骨架(3)的近端设有径向不可变的第二环(32);And/or, the distal end of the balloon skeleton (3) is provided with a radially immutable first ring (31), and the proximal end of the balloon skeleton (3) is provided with a radially immutable second ring (32); 和/或,所述球囊骨架(3)由丝线编而成或由中空管切割形成;And/or, the balloon skeleton (3) is formed by weaving silk threads or cutting a hollow tube; 和/或,所述囊体(4)和所述球囊充盈通道的外表面覆设编织层;and/or, the outer surfaces of the balloon body (4) and the balloon filling channel are covered with a woven layer; 和/或,所述囊体(4)与所述球囊充盈通道为一体成形;and/or, the capsule (4) and the balloon filling channel are integrally formed; 和/或,所述囊体(4)的外表面涂覆亲水涂层;and/or, the outer surface of the capsule (4) is coated with a hydrophilic coating; 和/或,所述囊体(4)的材质为高分子材料;And/or, the capsule (4) is made of a polymer material; 和/或,所述球囊骨架(3)的材质为可显影的高分子材料;And/or, the material of the balloon skeleton (3) is a developable polymer material; 和/或,所述操作手柄(1)上设有与所述第一腔道(21)相连通的第一出入口(11)、与所述第二腔道(22)相连通的第二出入口(12)。And/or, the operating handle (1) is provided with a first entrance (11) communicating with the first cavity (21) and a second entrance (12) communicating with the second cavity (22). 12.根据权利要求1所述的球囊扩张导管,其特征在于:所述球囊扩张导管还包括套设在所述导管(2)和所述囊体(4)外部的导管鞘。12. The balloon dilatation catheter according to claim 1, characterized in that: the balloon dilatation catheter further comprises a catheter sheath which is sleeved on the outside of the catheter (2) and the balloon body (4).
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