WO2022174557A1 - 球囊导管牵开器 - Google Patents

球囊导管牵开器 Download PDF

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Publication number
WO2022174557A1
WO2022174557A1 PCT/CN2021/109615 CN2021109615W WO2022174557A1 WO 2022174557 A1 WO2022174557 A1 WO 2022174557A1 CN 2021109615 W CN2021109615 W CN 2021109615W WO 2022174557 A1 WO2022174557 A1 WO 2022174557A1
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WO
WIPO (PCT)
Prior art keywords
balloon
mesh
balloon catheter
retractor according
catheter retractor
Prior art date
Application number
PCT/CN2021/109615
Other languages
English (en)
French (fr)
Inventor
张智超
马长生
董建增
Original Assignee
上海科赐医疗技术有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海科赐医疗技术有限公司 filed Critical 上海科赐医疗技术有限公司
Priority to US18/277,819 priority Critical patent/US20240307046A1/en
Priority to EP21926271.4A priority patent/EP4295885A1/en
Priority to JP2023550035A priority patent/JP2024507217A/ja
Publication of WO2022174557A1 publication Critical patent/WO2022174557A1/zh
Priority to US18/235,399 priority patent/US20240008864A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10184—Means for controlling or monitoring inflation or deflation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00818—Treatment of the gastro-intestinal system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00862—Material properties elastic or resilient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00955—Material properties thermoplastic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B2017/0212—Cushions or pads, without holding arms, as tissue retainers, e.g. for retracting viscera
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
    • A61B2017/0225—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery flexible, e.g. fabrics, meshes, or membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1059—Balloon catheters with special features or adapted for special applications having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1075—Balloon catheters with special features or adapted for special applications having a balloon composed of several layers, e.g. by coating or embedding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1084—Balloon catheters with special features or adapted for special applications having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/105—Oesophagus

Definitions

  • the invention relates to the field of medical devices, in particular to a balloon catheter retractor.
  • a non-compliant material is used to create a C-profile balloon.
  • the residual air in the balloon is evacuated by suction, and a rigid straight guide wire is passed through the balloon axis to adjust the C-shaped collapsed balloon into a straight line.
  • the balloon is sent into the esophageal lumen, the rigid straight guide wire is drawn out, and the liquid is injected and maintained at a certain liquid pressure (greater than 4 atmospheres), the balloon will return to the prefabricated C-shaped structure and provide support. So as to achieve the purpose of pulling.
  • the initial diameter of the balloon is relatively thick, usually greater than 8 mm.
  • this type of retractor can only enter the esophageal lumen through the oral cavity, but cannot reach the esophageal lumen through the nasal cavity. And because it must pass through the oral cavity, it has a great impact on the patient's feeling, so it can only be used in patients under general anesthesia (without consciousness), and cannot be used in awake patients.
  • Another type of retractor uses a semi-compliant balloon, which is characterized in that the axis of the balloon is eccentric and the axis of the balloon is locally reinforced. Therefore, when the balloon is inflated, the inflation rates on both sides of the axis of the balloon are different, causing the balloon to bend. Eventually, as the balloon inflates, the balloon will form a C-shaped structure to open the esophagus. However, in this solution, as the balloon expands, its material becomes thinner, and the pulling force of the balloon rises and then falls. At the same time, the radial expansion of the balloon hinders the axial expansion of the balloon, causing the balloon to bend during bending. The difference in the expansion ratio in the direction is reduced, and the bending effect is weakened. Therefore, under this scheme, the pulling force of the balloon will decrease over time, and in actual use, the bending force cannot be maintained, so it cannot meet the clinical needs.
  • the purpose of the present invention is to solve the problems that the existing balloon catheter retractor has a great influence on the patient's feeling and the bending force cannot be maintained, and provides a balloon catheter retractor, which can enhance its bending ability and enhance its ability to maintain its bending. performance characteristics.
  • the present invention provides a balloon catheter retractor, including a balloon catheter and a balloon fixed on the balloon catheter; when the balloon is filled with fluid, the balloon bends, and the balloon catheter is pulled to make Corresponding bending; applying a radial limit to the balloon, so that the balloon will no longer expand in the diameter direction when it expands to a certain diameter.
  • the balloon is a semi-compliant balloon that is eccentric to the axis.
  • the balloon is given a fixed length restriction on the inner side of the axial direction of the expected bending, and no restriction is imposed on the outer side of the expected bending direction of the balloon.
  • a limit to the inner length of the balloon's axial intended bending direction may be a stiffener inboard of the balloon's bending direction.
  • the limit to the medial length of the axial intended bending direction of the balloon may be a line on the balloon that fixes the inner side of the bending direction of the balloon.
  • a limit to the medial length of the balloon's axial intended bending direction may be a wire affixed to both ends of the balloon.
  • the radial limit of the balloon can be given a fixed diameter mesh, a sleeve or another balloon.
  • the radial limitation of the balloon can be achieved by modifying the partial area of the balloon to increase the modulus and stiffness of the partial area of the balloon.
  • the radial limit of the balloon is a braided mesh on the outer periphery of the balloon, and the braided mesh has different tensile properties in the radial direction and the axial direction.
  • the warp of the woven mesh has a strong modulus of elasticity, which is not easy to stretch and the diameter is fixed; the weft of the woven mesh has good elasticity, so that the woven mesh has tensile properties in the axial direction.
  • the weaving method of the woven mesh is denser on the warp and sparser on the weft.
  • the two ends of the braided mesh are fixed at both ends of the balloon, and the folded and rolled shape of the mesh and the balloon is taken as the initial state.
  • the braided mesh When in use, the braided mesh follows the bending as the balloon inside the balloon catheter expands and bends; After the diameter of the balloon reaches the preset diameter of the woven mesh, the balloon is inflated, and the diameter of the balloon does not change.
  • the weft of the woven mesh is a multi-segment short thread, so that the woven mesh forms a multi-segmented woven mesh structure.
  • the multi-segment woven mesh has several intact wefts as a fixed length limit on the inner side of the expected bending direction of the balloon axial direction.
  • one or a plurality of nearby weft threads of the woven mesh are replaced with the same material as the warp threads.
  • the material used in the balloon is an anisotropic material with a small elastic modulus in the axial direction and a large elastic modulus in the radial direction.
  • a series of radial reinforcing ribs or reinforcing meshes are coated on its outer surface.
  • the radial reinforcing rib or the reinforcing mesh is covered with a polymer film for fixing the reinforcing rib or the reinforcing mesh.
  • the radial limit of the balloon is that the balloon is embedded with a woven mesh, and the inner side of the balloon and the outer side of the balloon are made of thermoplastic elastomer material and covered with the woven mesh.
  • the radial limitation of the balloon is that a memory metal mesh whose memory shape is a contracted shape is attached to the balloon jacket.
  • the diameter of the memory metal mesh shrinks to its original state.
  • the memory metal mesh retains at least one fixed-length memory metal wire on the inner side of the expected bending direction of the balloon axial direction.
  • the beneficial effect of the present invention is to add a radial limit to the balloon, which is not limited in the axial direction, so as to achieve the purpose of not expanding in the diameter direction when the balloon is inflated to a predetermined diameter, so that the balloon is not inflated in the diameter direction.
  • the expansion tendency of the balloon is more concentrated in its expansion in the axial direction, thereby achieving an increase in the curvature and bending stiffness of the balloon.
  • the significance of the present invention is that the bending strength of the balloon is greatly increased, and at the same time, the bending strength of the balloon will not be attenuated with the passage of time, thereby ensuring the effect of pulling the esophagus by the balloon.
  • FIG. 1 is a schematic diagram of one embodiment of the present invention.
  • FIG. 2 is a cross-sectional view of one embodiment of the present invention.
  • FIG. 3 is an enlarged schematic diagram of a partial mesh of a woven mesh according to an embodiment of the present invention.
  • FIG. 4 is a schematic diagram of a second embodiment of the present invention.
  • FIG. 5 is an enlarged schematic view of the woven mesh according to the second embodiment of the present invention.
  • FIG. 6 is a schematic diagram of a third embodiment of the present invention.
  • FIG. 7 is a schematic diagram of a fourth embodiment of the present invention.
  • FIG. 8 is a cross-sectional view of a fourth embodiment of the present invention.
  • FIG. 9 is a schematic diagram of a fifth embodiment of the present invention.
  • FIG. 10 is a schematic diagram of the memory metal mesh of the present invention.
  • the solution of the present invention is to add a radial limit to the balloon, which is not limited in the axial direction, so as to achieve the purpose of not expanding in the diameter direction when the balloon is inflated to a predetermined diameter, so that the balloon is not inflated in the diameter direction.
  • the expansion trend of the balloon is more concentrated in the expansion in its axial direction, so as to achieve the purpose of increasing the curvature and bending stiffness of the balloon.
  • the scheme is as follows: first, a semi-compliant balloon is used to manufacture a balloon eccentric to the axis, and then a diameter limit is given to the diameter of the balloon. As the balloon is inflated to the end diameter of the expected inflation, the diameter of the balloon is no longer inflated, and the inflation direction in the axial direction is not restricted, and the balloon continues to bend. Over time, this protocol allows the balloon to maintain flex and flex strength.
  • Another solution is as follows: first, a semi-compliant balloon is used to make a balloon eccentric to the axis, and then a limit is given to the diameter of the balloon, and a fixed length limit is given to the inner side of the expected bending direction of the balloon, No restriction is placed on the outside of the expected bending direction of the balloon.
  • the braided tube limits the diameter of the balloon, and at the same time, the inner length in the bending direction is reinforced and limited, so as to achieve the purpose of increasing the bending force.
  • the diameter of the above-mentioned constraining balloon can be given a fixed diameter of mesh cloth, a sleeve or another balloon; it can also be modified to increase the modulus and stiffness of the partial area of the balloon by modifying the partial area of the balloon.
  • Constraining the axial portion of the balloon can be a stiffener, a wire fixed to the balloon, or a wire fixed to both ends of the balloon.
  • FIG. 1 is a schematic diagram of an embodiment of the present invention.
  • a balloon catheter retractor 1 is shown in FIG. 1 .
  • the center of the balloon catheter retractor 1 is an eccentric balloon 12 , and its outer periphery is a layer of woven mesh 15 .
  • the braided mesh 15 adjusts the properties of the material on the warp and weft (such as the elastic modulus of the material, elongation at break) and the weaving method (the density of the warp and the weft), so that the pipe formed by the braided mesh can be radially and axially. different tensile properties.
  • FIG. 2 is a cross-sectional view of an embodiment of the present invention.
  • FIG. 3 is an enlarged schematic diagram of a partial mesh of a woven mesh according to an embodiment of the present invention.
  • the line parallel to the axis 10 of the balloon catheter is defined as the weft 51 of the braided mesh, and the line perpendicular to it is the warp of the braided mesh 52 .
  • the warp 52 of the woven mesh has a strong modulus and is not easily stretched and has a fixed diameter, and the weft 51 of the woven mesh has good elasticity, which is characterized by having tensile properties in the longitudinal direction.
  • the two ends of the woven mesh 15 are fixed to the two ends of the balloon 12, and the mesh and the balloon are folded and rolled as the initial state by the method of folding and rolling after the fluid in the balloon 12 is exhausted. In this way, it can be ensured that the balloon catheter 13 can meet the transportability requirements of the balloon in the channel before use.
  • the braided mesh will follow the bending.
  • the diameter of the balloon reaches the preset diameter of the woven mesh, the balloon is filled again, and the diameter of the balloon does not change, so as to limit the expansion of the balloon in the diameter, thereby enhancing its extension in the axial direction.
  • FIG. 4 is a schematic diagram of a second embodiment of the present invention.
  • a balloon catheter retractor 2 is shown in FIG. 4 , the center of the balloon catheter retractor 2 is an eccentric balloon 12 , and a layer of braided mesh 25 is formed around it.
  • FIG. 5 is an enlarged schematic view of the woven mesh according to the second embodiment of the present invention.
  • FIG. 5 shows an enlarged form of the braided mesh 25 , and the lines parallel to the axis 10 of the balloon catheter are defined as the weft threads of the braided mesh 61 , and the lines perpendicular thereto are defined as the braided mesh warp threads 62 .
  • the warp 62 of the woven mesh 25 has a strong modulus and is not easily stretched and has a fixed diameter, and the weft of the woven mesh is multi-segmented short wires so that the woven mesh forms a multi-segmented structure.
  • the stretched side of the balloon is free to expand in the axial direction because the weft thread is multiple short threads and is not bound by the length of the entire weft thread.
  • the meridian 61 is radially constrained to provide greater deformation for axial expansion of the balloon so that the balloon can maintain flexure and stiffness.
  • FIG. 6 is a schematic diagram of a third embodiment of the present invention.
  • FIG. 6 shows a balloon catheter retractor 3 with a radially reinforced balloon 32 at the center of the balloon catheter retractor 3 .
  • the characteristic of this balloon 32 is that it will not continue to expand to increase the diameter after it has been expanded to a predetermined diameter in the diameter direction, but can be freely expanded in the axial direction without restriction.
  • the specific scheme includes: the material used for the balloon 32 is an anisotropic material, which is characterized by a smaller elastic modulus in the axial direction and a larger elastic modulus in the radial direction.
  • the balloon 32 is covered with a series of radial reinforcing ribs or a reinforcing net, and then a polymer film is coated on the outside to fix the reinforcing ribs or the reinforcing net to make the outer surface smooth and the internal reinforcing ribs. Or strengthen the net relatively fixed.
  • FIG. 7 is a schematic diagram of a fourth embodiment of the present invention.
  • Figure 7 shows the balloon catheter retractor 4, the center of the balloon catheter retractor 4 is an embedded woven mesh reinforced balloon 42.
  • the characteristic of this balloon 42 is that in the process of diametrical expansion, its axial direction is slightly contracted, and when its diametrical direction expands to the expected diameter, its shape is fixed, so that the entire balloon is no longer expanded in the radial direction and instead Axial expansion.
  • FIG. 8 which is a cross-sectional view of the fourth embodiment of the present invention. It can be seen in FIG. 8 that the balloon 42 is divided into the inner side 43 of the balloon, the interlayer woven mesh 44 and the outer layer 45 of the balloon.
  • Both the inner side 43 of the balloon and the outer side 45 of the balloon are made of thermoplastic elastomer and are covered with a woven mesh 44 .
  • the braided mesh 44 With the radial expansion of the balloon, the braided mesh 44 is deformed, but due to the existence of the thermoplastic elastomer between the meshes of the braided mesh 44, the deformation will reach the end point, so as to achieve the effect of not expanding in the diameter direction and continuing to expand in the axial direction.
  • the shape of the mesh of the woven mesh tends to change, but the polymer material inside tends to maintain the original shape, which will cause resistance, so that the deformation of the woven mesh is limited.
  • FIG. 9 is a schematic diagram of a fifth embodiment of the present invention.
  • Fig. 9 shows the balloon catheter retractor 5.
  • the center of the balloon catheter retractor 5 is an eccentric balloon 12, and a memory metal mesh 91 is attached to its outer sleeve.
  • the memory metal mesh 91 is characterized in that its memory shape is contracted form. As the balloon 12 expands, its diameter adheres to the surface of the balloon 12 and expands but its length direction does not expand.
  • a further preferred reinforcement solution of the present invention is to add a rib with a fixed length to the inner side of the expected bending direction of the balloon in the above-mentioned solution. This increases the hold-to-length limit of the balloon axially inboard of the intended bending direction of the balloon.
  • the several wefts 51 of the inner side 18 of the axial direction of the expected bending direction of the multi-segment woven mesh 25 are reinforced, so as to achieve the characteristic that the inner side of the multi-segment woven mesh is more difficult to extend in the expected bending direction, thereby enhancing the balloon bending effect. .
  • FIGS. 9 and 10 is a schematic diagram of the memory metal mesh of the present invention.
  • the ductility of the memory metal in the linear direction is more difficult than that of the polymer material, at least one memory metal wire of fixed length is maintained on the inner side 18 of the expected bending direction in the axial direction.
  • the inner side 18 of the axial direction of the expected bending direction has no ductility, but the ductility on the extension side 17 is maintained so as to achieve a stronger bending effect.

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  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Child & Adolescent Psychology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
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Abstract

一种球囊导管牵开器（1），包括球囊导管（13）以及固定在球囊导管（13）上的球囊（12）；当向球囊（12）中充流体时，球囊（12）弯曲，并牵动球囊导管（13）做相应的弯曲；通过给球囊（12）施加一个径向的限位，使球囊（12）在膨胀到一定直径的时候不再在直径方向上膨胀。该球囊导管牵开器（1）可以增强其弯曲能力以及增强其保持其弯曲性能的特性。

Description

球囊导管牵开器 技术领域
本发明涉及医疗器械领域，尤其是球囊导管牵开器。
背景技术
现有应用球囊来牵开食管的牵开器的方案有以下两种：
使用非顺应性材料制造出C型轮廓的球囊，在使用之前通过抽吸排出球囊内残余空气，同时用硬质直导丝通过球囊轴线从而将C型的坍缩后球囊调整成直线。使用时将球囊送入食管腔道，抽出硬质直导丝后通过打入液体并保持一定液体压力(大于4个大气压)后，球囊会恢复成预制C型的结构并提供支撑力从而达到牵拉的目的。但是这种方式下，由于使用的是非顺应性球囊，使得球囊的初始直径就较粗，通常大于8毫米，同时它进入腔道时需要内嵌一根硬质直导丝来保证其通过时的形态。因此这种方案下这类牵开器只能通过口腔进入食管腔道，而无法通过鼻腔到达食管腔道。又因为其必须通过口腔，对患者的感受影响较大，因此只能在全身麻醉(无知觉)的病人中使用，无法对清醒的病人使用。
另一种牵开器是使用半顺应性球囊，其特征是球囊的轴线偏心并且局部加强球囊的轴线。从而在球囊膨胀时，球囊轴线两侧的膨胀率不同，使得球囊发生弯曲。最终随着球囊膨胀，球囊会形成C型结构从而达到拉开食管的目的。然而在这种方案下，随着球囊的膨胀，其材料变薄，球囊牵拉 力上升后又下降，同时球囊的径向膨胀阻碍了球囊的轴向膨胀，使得球囊在弯曲方向上的膨胀率的差值减小，弯曲效果被减弱。因此在这种方案下，球囊的牵拉力随着时间推移会下降，在实际使用过程中，弯曲力不可维持，因此不能满足临床需求。
发明内容
本发明的目的在于解决现有球囊导管牵开器对患者的感受影响较大和弯曲力不可维持的问题，提供了一种球囊导管牵开器，可以增强其弯曲能力以及增强其保持其弯曲性能的特性。
为了实现这一目的本发明提供了球囊导管牵开器，包括球囊导管以及固定在球囊导管上的球囊；当向球囊中充流体时，球囊弯曲，并牵动球囊导管做相应的弯曲；给球囊施加一个径向的限位，使球囊在膨胀到一定直径的时候不再在直径方向上膨胀。
其中，球囊为用半顺应性球囊制造出对轴线偏心的球囊。球囊在轴向预期弯曲方向的内侧给定一个定长的限制，在球囊轴向预期弯曲方向的外侧不加限制。球囊的轴向预期弯曲方向的内侧定长的限制可以是球囊弯曲方向内侧的加强筋。球囊的轴向预期弯曲方向的内侧定长的限制可以是固定球囊弯曲方向内侧在球囊上的线。球囊的轴向预期弯曲方向的内侧定长的限制可以是固定在球囊两端的线。球囊的径向的限位可以是给定一个固定直径的网布、套子或者另一个球囊。球囊的径向的限位可以是通过对球囊的部分区域进行改性从而增加球囊部分区域的模量和刚度。
较佳的，球囊径向的限位是球囊外周的编织网，所述的编织网在径向和轴向的拉伸特性不同。编织网的经线具有较强的弹性模量，不易拉伸而固定直径；所述的编织网的纬线具有良好的弹性，使得编织网在轴向上具 备拉伸特性。编织网的编织方法为经线上较密而纬线上较疏。编织网的两端固定在球囊的两端，将网和球囊折叠收卷的形态作为初始状态，在使用时，随着球囊导管内部的球囊膨胀弯曲，编织网跟随弯曲；当球囊的直径到达编织网的预设直径后，再充盈球囊，球囊的直径不再变化。编织网的纬线为多段短线使得编织网形成多段编织网的结构。多段编织网在球囊轴向预期弯曲方向的内侧有几根完整纬线作为定长限制。编织网在球囊轴向预期弯曲方向的内侧有一根或者附近复数根编织网纬线替换成经线相同材质。球囊使用的材料是各向异性的材料，轴向上弹性模量较小而在径向上弹性模量较大。球囊成型后再在其外包覆一系列的径向加强筋或者加强网。径向加强筋或者加强网外部包覆高分子膜用于固定加强筋或者加强网。
进一步的，球囊径向的限位是所述的球囊内嵌编织网，球囊内侧与球囊外侧均为热塑性弹性体材料，包覆着编织网。
此外，球囊径向的限位是所述的球囊外套附了一个记忆形态为收缩形态的记忆金属网。记忆金属网的直径会收缩到原始状态。记忆金属网在球囊轴向预期弯曲方向的内侧保持有至少一根定长的记忆金属丝。
本发明的有益效果是给球囊的增加一个径向的限位，在轴向的不加限制，从而达到球囊在膨胀到既定直径的时候不再在直径方向上膨胀的目的，使得球囊的膨胀趋势更多集中在其轴向方向的膨胀，从而达到增加球囊弯曲度和弯曲刚度。本发明的意义在于极大增加了球囊的弯曲力度，同时随着时间推移，球囊的弯曲力度不会衰减，从而确保了球囊牵拉食管的效果。
为使本发明的上述目的、特征和优点能更明显易懂，下文特举较佳实施例，并配合所附附图，作详细说明如下。
附图说明
为了更清楚地说明本发明具体实施方式或现有技术中的技术方案，下面将对具体实施方式或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本发明的一些实施方式，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为本发明的一个实施例的示意图。
图2为本发明的一个实施例的剖面图。
图3为本发明的一个实施例的编织网局部网格放大示意图。
图4为本发明的第二实施例的示意图。
图5为本发明的第二实施例的编织网的放大形态示意图。
图6为本发明的第三实施例的示意图。
图7为本发明的第四实施例的示意图。
图8为本发明的第四实施例的剖面图。
图9为本发明的第五实施例的示意图。
图10为本发明的记忆金属网的示意图。
具体实施方式
下面将结合本发明实施例中附图，对本发明实施例中的技术方案进行清楚、完整的描述。显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。通常在此处附图中描述和示出的本发明实施例的组件可以以各种不同的配置来布置和设计。因此，以下对在附图中提供的本 发明的实施例的详细描述并非旨在限制要求保护的本发明的范围，而是仅仅表示本发明的选定实施例。基于本发明的实施例，本领域技术人员在没有做出创造性劳动的前提下所获得的所有其他实施例，都属于本发明保护的范围。
本发明的解决方案是给球囊的增加一个径向的限位，在轴向的不加限制，从而达到球囊在膨胀到既定直径的时候不再在直径方向上膨胀的目的，使得球囊的膨胀趋势更多集中在其轴向方向的膨胀，从而达到增加球囊弯曲度和弯曲刚度的目的。
方案如下：先利用半顺应性球囊制造出对轴线偏心的球囊，然后给球囊的直径方向给一个直径的限制。随着球囊膨胀到预期膨胀的终点直径，球囊直径不再膨胀，而在轴向的膨胀方向不受到限制，球囊持续弯曲。随着时间推移，这个方案可以使球囊保持弯曲度和弯曲力度。
另一个方案如下：先利用半顺应性球囊制造出对轴线偏心的球囊，然后给球囊的直径方向给定一个限制，同时给球囊预期弯曲方向的内侧给定一个定长的限制，给球囊预期弯曲方向的外侧不加限制。这样随着球囊直径增加到预设直径，编织管限制球囊直径，同时弯曲方向的内侧长度受到加强限制，从而达到提高弯曲力的目的。
上述的限制球囊的直径可以是给定一个固定直径的网布、套子或者另一个球囊；也可以是通过对球囊的部分区域进行改性从而增加球囊部分区域的模量和刚度。给球囊的轴向部分限制可以是一条加强筋，也可以是一条固定在球囊上的线或者固定在球囊两端的线。
下面对本发明做进一步的详细说明，以令本领域技术人员参照说明文字能够据以实施。
首先请参照图1，图1为本发明的一个实施例的示意图。在图1中展示了球囊导管牵开器1，球囊导管牵开器1的中心是偏心的球囊12，其外周为一层编织网15。编织网15通过调整经线纬线上材料的属性(例如材料的弹性模量，断裂伸长率)与编织方法(经线上与纬线上的疏密)，使得编织网形成的管材在径向和轴向的拉伸特性不同。
接下来请参阅图2，图2为本发明的一个实施例的剖面图。在图2中可以看到该实施例由内到外的三层剖面，分别是最内层的球囊导管13，以及套接在球囊导管13外层的球囊12，然后是最外层套在球囊12上的编织网15。
再请参阅图3，图3为本发明的一个实施例的编织网局部网格放大示意图。定义与球囊导管轴线10平行的线为编织网纬线51，与其垂直的线为编织网经线52。编织网的经线52具有较强的模量不易拉伸并且固定直径，编织网的纬线51具有良好的弹性，其特征是在长度方向上具备拉伸特性。
将编织网15的两端固定在球囊12的两端，同时利用将球囊12内流体排尽后折叠收卷的方法将网和球囊呈折叠收卷的形态作为初始状态。这样可以确保球囊导管13使用前可以满足球囊在通道的可输送性要求。同时这种方案在使用时，随着球囊导管13内部的球囊膨胀弯曲，编织网跟随弯曲。同时当球囊的直径到达编织网的预设直径后，再充盈球囊，球囊的直径不再变化，达到限制球囊在直径上膨胀的作用，从而加强了其在轴向的延展。
图4为本发明的第二实施例的示意图。图4中展示了球囊导管牵开器2，球囊导管牵开器2的中心是偏心的球囊12，其外周为一层编织网25。
图5为本发明的第二实施例的编织网的放大形态示意图。图5展示了编织网25的放大形态，定义与球囊导管轴线10平行的线为编织网纬线61， 与其垂直的线为编织网经线62。编织网25的经线62具有较强的模量不易拉伸并且固定直径，编织网的纬线为多段短线使得编织网形成多段的结构。
随着球囊12的充盈膨胀弯曲，球囊的伸展侧由于纬线是多段短线，没有整条纬线长度的束缚，可以自由在轴向膨胀，而在径向上随着球囊膨胀触及编织网25的经线61在径向上受到限制，从而给球囊的轴向膨胀提供更大的形变从而使得球囊可以保持弯曲度与刚度。
图6为本发明的第三实施例的示意图。图6展示了球囊导管牵开器3，球囊导管牵开器3的中心是一个径向加强的球囊32。这个球囊32的特征是其在直径方向膨胀到既定直径后不会继续膨胀增加直径而在轴线方向上可以不受限制的自由膨胀。具体方案包括：球囊32使用的材料是各向异性的材料，其特征是在轴向上弹性模量较小而在径向上弹性模量较大。或者是在球囊32成型后再其外包覆一系列的径向加强筋或者加强网后在其外部包覆高分子膜用于固定加强筋或者加强网使得其外表面光滑且内部的加强筋或加强网相对固定。
图7为本发明的第四实施例的示意图。图7展示了球囊导管牵开器4，球囊导管牵开器4的中心是一个内嵌编织网加强的球囊42。这个球囊42的特征是其在直径方向膨胀的过程中，其轴向会略微收缩，当其直径方向膨胀到预期直径时，其形态固定，使得整个球囊在径向不再膨胀转而在轴向膨胀。其具体结构见图8，图8为本发明的第四实施例的剖面图。图8中可以看到球囊42分为了球囊内侧43、夹层编织网44和球囊外层45。球囊内侧43与球囊外侧45均为热塑性弹性体材料，包覆着编织网44。随着球囊的径向膨胀，编织网44形变，但是编织网44网格间由于热塑性弹性体的存在，其形变会达到终点，从而达到其直径方向不膨胀，轴向继续膨胀的效果。在形变的过程中，编织网的网格的形状倾向变化，但是里面的高 分子材料会倾向于保持原来形状，这样就会产生对抗，从而使得编织网的形变是有限的。
图9为本发明的第五实施例的示意图。图9展示了球囊导管牵开器5，球囊导管牵开器5中心是一个偏心的球囊12，其外套附了一个记忆金属网91，这个记忆金属网91的特征是其记忆形态为收缩形态。随着球囊12的膨胀，其直径贴附在球囊12表面膨胀但其长度方向不膨胀。随着记忆金属网91的形变，最终其径向的环会拉直成圆环从而限制球囊直径的膨胀，而其径向长度不会发生改变，同时其在球囊延展侧没有金属线限制其延长，因此球囊12弯曲后其直径会被记忆金属网91限制而其弯曲不会被限制，从而达到了增强球囊弯曲力与保持弯曲形态的性能。本方案另一个优势是随着球囊12的收缩，记忆金属网91由于其记忆属性，其直径会收缩到原始状态从而达成包覆在球囊导管上的效果，减小了收缩后的器械体积，方便了其在回撤时的通过性。
本发明进一步的优选增强方案是在上述方案中在球囊轴向预期弯曲方向的内侧加上一根定长的筋。从而在球囊轴向预期弯曲方向的内侧增加球囊的定长限制。
再参考图1到图3，为第一种球囊导管牵开器方案。在这种方案下，将球囊12轴向预期弯曲方向的内侧18的一根或者附近复数根编织网纬线51替换成径线52相同材质，从而达到网在其轴向预期弯曲方向的内侧18的长度不发生变化，从而从外部增强了球囊的弯曲效果。随着球囊的膨胀，球囊与编织网15互相挤压，产生较大的摩擦力，从而相对固定。随着球囊的弯曲，其轴向预期弯曲方向的内侧18的长度同时通过球囊导管13和轴向预期弯曲方向的内侧18的纬线固定其长度，从而确保球囊轴向预期弯曲方向的内侧18和延展侧17的长度差不会随着时间推移而减小，从而达到 了保持球囊导管1的弯曲型和弯曲力的能力。
再参考图4与图5。在这种方案下，将多段编织网的25的轴向预期弯曲方向的内侧18的几根纬线51增强，从而达到其轴向预期弯曲方向的内侧更加不易延长的特性，从而增强球囊弯曲效果。
再参考图9和图10。其中图10为本发明的记忆金属网的示意图。在这种方案下，由于记忆金属在直线方向的延展性相比于高分子材料已经更难延展了，所以在其轴向预期弯曲方向的内侧18保持有至少一根定长的记忆金属丝即可使得球囊导管13在弯曲的过程中，其轴向预期弯曲方向的内侧18无延展性，而在其延展侧17的延展性保持从而达到更强的弯曲效果。
弯曲尽管本发明的实施方案已公开如上，但其并不仅仅限于说明书和实施方式中所列运用。它完全可以被适用于各种适合本发明的领域。对于熟悉本领域的人员而言可以容易实现另外的修改。因此在不背离权利要求及等同范围所限定的一般概念下，本发明并不限于特定的细节和这里展示和描述的图例。

Claims (22)

  1. 球囊导管牵开器，包括球囊导管以及固定在球囊导管上的球囊；当向球囊中充流体时，球囊弯曲，并牵动球囊导管做相应的弯曲；其特征在于给球囊施加一个径向的限位，使球囊在膨胀到一定直径的时候不再在直径方向上膨胀。
  2. 如权利要求1所述的球囊导管牵开器，其特征在于所述的球囊为用半顺应性球囊制造出对轴线偏心的球囊。
  3. 如权利要求1所述的球囊导管牵开器，其特征在于所述的球囊在轴向预期弯曲方向的内侧给定一个定长的限制，在球囊轴向预期弯曲方向的外侧不加限制。
  4. 如权利要求3所述的球囊导管牵开器，其特征在于所述的球囊的轴向预期弯曲方向的内侧定长的限制可以是球囊弯曲方向内侧的加强筋。
  5. 如权利要求3所述的球囊导管牵开器，其特征在于所述的球囊的轴向预期弯曲方向的内侧定长的限制可以是固定球囊弯曲方向内侧在球囊上的线。
  6. 如权利要求3所述的球囊导管牵开器，其特征在于所述的球囊的轴向预期弯曲方向的内侧定长的限制可以是固定在球囊两端的线。
  7. 如权利要求1所述的球囊导管牵开器，其特征在于所述的球囊的径向的限位可以是给定一个固定直径的网布、套子或者另一个球囊。
  8. 如权利要求1所述的球囊导管牵开器，其特征在于所述的球囊的径向的限位可以是通过对球囊的部分区域进行改性从而增加球囊部分区域的模量和刚度。
  9. 如权利要求1所述的球囊导管牵开器，其特征在于所述的球囊径向的限位是球囊外周的编织网，所述的编织网在径向和轴向的拉伸特性不同。
  10. 如权利要求9所述的球囊导管牵开器，其特征在于所述的编织网的 经线具有较强的弹性模量，不易拉伸而固定直径；所述的编织网的纬线具有良好的弹性，使得编织网在轴向上具备拉伸特性。
  11. 如权利要求9所述的球囊导管牵开器，其特征在于所述的编织网的编织方法为经线上较密而纬线上较疏。
  12. 如权利要求9所述的球囊导管牵开器，其特征在于所述的编织网的两端固定在球囊的两端，将网和球囊折叠收卷的形态作为初始状态，在使用时，随着球囊导管内部的球囊膨胀弯曲，编织网跟随弯曲；当球囊的直径到达编织网的预设直径后，再充盈球囊，球囊的直径不再变化。
  13. 如权利要求9所述的球囊导管牵开器，其特征在于所述的编织网的纬线为多段短线使得编织网形成多段编织网的结构。
  14. 如权利要求13所述的球囊导管牵开器，其特征在于所述的多段编织网在球囊轴向预期弯曲方向的内侧有几根完整纬线作为定长限制。
  15. 如权利要求9所述的球囊导管牵开器，其特征在于所述的编织网在球囊轴向预期弯曲方向的内侧有一根或者附近复数根编织网纬线替换成经线相同材质。
  16. 如权利要求1所述的球囊导管牵开器，其特征在于所述的球囊径向的限位是所述的球囊使用的材料是各向异性的材料，轴向上弹性模量较小而在径向上弹性模量较大。
  17. 如权利要求1所述的球囊导管牵开器，其特征在于所述的球囊径向的限位是在球囊成型后再在其外包覆一系列的径向加强筋或者加强网。
  18. 如权利要求17所述的球囊导管牵开器，其特征在于所述的径向加强筋或者加强网外部包覆高分子膜用于固定加强筋或者加强网。
  19. 如权利要求1所述的球囊导管牵开器，其特征在于所述的球囊径向的限位是所述的球囊内嵌编织网，球囊内侧与球囊外侧均为热塑性弹性体材料，包覆着编织网。
  20. 如权利要求1所述的球囊导管牵开器，其特征在于所述的球囊径向 的限位是所述的球囊外套附了一个记忆形态为收缩形态的记忆金属网。
  21. 如权利要求20所述的球囊导管牵开器，其特征在于所述的记忆金属网的直径会收缩到原始状态。
  22. 如权利要求20所述的球囊导管牵开器，其特征在于所述的球囊导管牵开器的球囊的记忆金属网在球囊轴向预期弯曲方向的内侧保持有至少一根定长的记忆金属丝。
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