WO2021238633A1 - 扩张球囊装置及扩张球囊装置的制作方法 - Google Patents

扩张球囊装置及扩张球囊装置的制作方法 Download PDF

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Publication number
WO2021238633A1
WO2021238633A1 PCT/CN2021/092735 CN2021092735W WO2021238633A1 WO 2021238633 A1 WO2021238633 A1 WO 2021238633A1 CN 2021092735 W CN2021092735 W CN 2021092735W WO 2021238633 A1 WO2021238633 A1 WO 2021238633A1
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WO
WIPO (PCT)
Prior art keywords
expandable
expandable cage
cage
flexible wall
balloon device
Prior art date
Application number
PCT/CN2021/092735
Other languages
English (en)
French (fr)
Inventor
何俊淅
吕守良
Original Assignee
成都赛拉诺医疗科技有限公司
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Application filed by 成都赛拉诺医疗科技有限公司 filed Critical 成都赛拉诺医疗科技有限公司
Publication of WO2021238633A1 publication Critical patent/WO2021238633A1/zh

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Classifications

    • 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
    • A61M25/1011—Multiple balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • 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
    • 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
    • A61M25/1011—Multiple balloon catheters
    • A61M2025/1013—Multiple balloon catheters with concentrically mounted balloons, e.g. being independently inflatable
    • 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
    • A61M2210/12—Blood circulatory system
    • A61M2210/125—Heart

Definitions

  • the present disclosure relates to the technical field of medical devices, and in particular to an expansion balloon device and a manufacturing method of the expansion balloon device.
  • Inflatable structures such as balloons
  • the balloon is typically placed within the end of the catheter before the balloon reaches the area of interest.
  • the balloon is released from the catheter, and a filling medium is infused into the balloon to inflate the balloon.
  • the balloon can be configured for heart valve treatment procedures, including during aortic balloon valvuloplasty (BAV) and transcatheter aortic valve implantation (TAVI).
  • the balloon can be configured to pre-dilate the narrowed valve site to facilitate the placement of the prosthetic valve, or it can be configured to expand the initially collapsed prosthetic valve when the prosthetic valve is placed and deployed.
  • Existing balloons include balloon-type balloons and non-balloon-type hollow balloons.
  • CN101959478B discloses a hollow balloon applicable to TAVI.
  • the hollow balloon is composed of a single expandable cage with limited expansion force;
  • the balloon is mainly configured as a prosthetic valve that is initially collapsed when the prosthetic valve is placed and deployed, and the middle section of the balloon is convex during expansion. If the balloon is used for pre-expansion of stenosis, the positioning and adhesion are not good. good.
  • an objective is to provide an expansion balloon device and a method for manufacturing the expansion balloon device.
  • an expansion balloon device including:
  • each expandable cage has a contracted state and an expanded state
  • the flexible wall is connected with the two expandable cages, the flexible wall at least partially surrounds the recess between the two expandable cages, and the flexible wall can expand with the expansion of the expandable cages.
  • the present disclosure also provides a manufacturing method of the expandable balloon device, the manufacturing method includes:
  • the proximal end of the first expandable cage, the proximal end of the second expandable cage, the distal end of the first expandable cage, and the distal end of the second expandable cage are moved from the proximal end to the distal end
  • the interval is set on the shaft;
  • the two ends of the flexible wall are respectively connected to the main body of the first expandable cage and the main body of the second expandable cage.
  • Fig. 1 is an exploded view of an expanding balloon device provided by an embodiment of the disclosure
  • FIG. 2 is a front view of the expanding balloon device in an expanded state according to an embodiment of the disclosure
  • Fig. 3 is a front view of the expansion balloon device in an expanded state provided by an embodiment of the present disclosure with two expandable cages with flexible walls hidden and arranged axially without crossing;
  • Fig. 4 is a front view of the expandable balloon device in a contracted state provided by an embodiment of the present disclosure with two expandable cages with flexible walls hidden and arranged axially without crossing;
  • FIG. 5 is a front view of the expansion balloon device in an expanded state provided by an embodiment of the disclosure with two expandable cages with flexible walls concealed in an axially intersecting arrangement;
  • Fig. 6 is a front view of the expandable balloon device with two expandable cages arranged axially and crosswise in a contracted state and with a hidden flexible wall according to an embodiment of the present disclosure
  • FIG. 7 is a schematic structural diagram of an expandable cage of an expandable balloon device provided by an embodiment of the disclosure.
  • Fig. 8 is a front view of an expansion balloon device provided with an axial rigid support provided by an embodiment of the disclosure
  • Fig. 9 is a front view of an expanding balloon device provided with a spiral rigid support provided by an embodiment of the disclosure.
  • FIG. 10 is a perspective view of the expanded balloon device with the membrane in the folded state provided by the embodiment of the disclosure (the blood flow channel is opened); FIG.
  • FIG. 11 is a perspective view of the expandable balloon device with the membrane in the expanded state (the blood flow channel is closed state) according to an embodiment of the disclosure.
  • Figure 12 is an end view of the expandable balloon device (the blood flow channel is opened, showing the assembly relationship between the membrane and the second expandable cage);
  • Figure 13 is another end view of the expandable balloon device (the blood flow channel is closed, showing the assembly relationship between the membrane and the second expandable cage);
  • FIG. 14 is a schematic diagram of a connection between the drive line of the expandable balloon device and two expandable cages according to an embodiment of the disclosure
  • FIG. 15 is a schematic diagram of yet another connection between the drive line of the expandable balloon device and two expandable cages according to an embodiment of the disclosure
  • 16 is a schematic diagram of the structure of the multi-lumen tube and the outer tube of the expandable balloon device provided by the embodiments of the disclosure;
  • FIG. 17 is a cross-sectional view of the multi-lumen tube of the expandable balloon device provided by an embodiment of the disclosure.
  • Icon 100-expandable balloon device; 110-expandable cage; 111-proximal; 112-distal; 113-body; 120-expandable cage; 121-proximal; 122-distal 123-Main body; 20-Axis; 21-Guide limit part; 30-Flexible wall; 31-Rigid support; 311-Axial rigid support; 312-Spiral rigid support; 40-Membrane; 50- Drive line; 51-main body; 52-first branch; 53-second branch; 540-first mount; 541-second mount; 542-third mount; 543-fourth mount; 60-more Lumen; 61-first lumen; 62-second lumen; 70-overtube.
  • orientation or positional relationship indicated by the terms “inner” and/or “outer” is based on the orientation or positional relationship shown in the accompanying drawings, or is a customary swing when the application product is used.
  • the orientation or positional relationship is only for the convenience of describing the present disclosure and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be construed as essential to the present disclosure. limit.
  • the terms “first”, “second”, etc. are only used for distinguishing description, and cannot be understood as indicating or implying relative importance.
  • connection should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection. , Or integrally connected; it can be directly connected, or indirectly connected through an intermediate medium, and it can be the internal communication between two components.
  • set and/or “connection” should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection. , Or integrally connected; it can be directly connected, or indirectly connected through an intermediate medium, and it can be the internal communication between two components.
  • the expansion balloon device 100 includes: a shaft 20, two expandable cages (hollow balloons) 110 and 120 and a flexible wall 30.
  • the shaft 20 is configured to mount two expandable cages 110,120.
  • the two expandable cages 110 and 120 are arranged on the shaft 20 along the axial direction, and the two expandable cages 110 and 120 are arranged coaxially. Both the expandable cages 110 and 120 have a contracted state and an expanded state, and the expandable cages 110 and 120 can expand radially outward with the shaft 20 as the center. During the expansion of the two expandable cages 110 and 120, a recess is always formed between the two expandable cages 110 and 120.
  • the flexible wall 30 is connected to the two expandable cages 110 and 120, and the flexible wall 30 at least partially surrounds the recess between the two expandable cages 110, 120.
  • the flexible wall 30 can expand with the expansion of the expandable cages 110, 120.
  • the flexible wall 30 expands with the expandable cages 110, 120, the flexible wall 30 adheres to the stenosis part of the valve and gradually expands the original narrow valve.
  • the positioning of the entire device is realized, and at the same time, it is convenient for the effective transmission of the expansion force.
  • the two expandable cages 110, 120 and the flexible wall 30 form an organic whole.
  • the two expandable cages A recess is always formed between the bodies 110 and 120, which facilitates the positioning of the valve during expansion.
  • the two expandable cages 110 and 120 jointly provide the expansion force, so that the expansion force is increased, which is significantly greater than the expansion force of one expandable cage, thereby improving the efficiency of stenosis expansion.
  • the flexible wall 30 directly contacts the narrow part to be expanded.
  • the probability of tissue trauma caused by the mechanical expansion of the expanding balloon device 100 is reduced; the flexible wall 30 directly contacts the narrow part to be expanded
  • the contact area of the stenosis is increased compared with that when the metal balloon directly contacts the valve, the adhesion is enhanced, and the expansion force of the expandable cage 110, 120 can be effectively transmitted to the stenosis, which is beneficial to expansion.
  • FIG. 3 and 4 are schematic diagrams of the two expandable cages 110, 120 not intersecting in the axial direction.
  • Figures 5 and 6 are schematic diagrams of two expandable cages 110 and 120 arranged crosswise in the axial direction.
  • the materials of the expandable cages 110 and 120 may be nickel titanium alloy (NiTi), stainless steel, etc., which have a certain supporting strength.
  • the material of the flexible wall 30 may be a non-elastic material, such as woven cloth, expanded polytetrafluoroethylene, or a certain elastic material, such as rubber or silicone.
  • the material of the shaft 20 may be stainless steel, which has a certain supporting strength.
  • the materials of the expandable cage bodies 110 and 120 and the shaft 20 may also be other metal materials, alloy materials, or non-metallic hard materials.
  • the expandable cage 110 is located at the proximal end, and the expandable cage 120 is located at the distal end.
  • the end close to the operator is defined as the proximal end, and the end far away from the operator is defined as the distal end.
  • the left end in FIG. 7 is the proximal end, and the right end is the distal end.
  • the expandable cage 110 includes a proximal portion 111, a distal portion 112, and a hollow main body portion 113.
  • the proximal portion 111 and the distal portion 112 are disposed on the shaft 20 and can move relative to each other (the relative movement here includes the proximal end).
  • the part 111 and the distal part 112 move relative to the shaft 20 at the same time, or one of the proximal part 111 and the distal part 112 moves relative to the shaft 20);
  • the main body part 113 connects the proximal part 111 and the distal part 112 and
  • the external mounting surface is defined, and the flexible wall 30 is connected to the external mounting surface (as shown in FIG. 2).
  • the main body 113 is arranged around the shaft 20.
  • the main body 113 has a certain degree of toughness. When the proximal end 111 and the distal end 112 are close to each other, the main body 113 can be arched. When the expandable cage 110 is in a contracted state, the proximal end 111 and the distal end 112 are separated by a first distance, and when the expandable cage 110 is in an expanded state, the proximal end 111 and the distal end 112 are separated by a second distance, The second distance is smaller than the first distance, that is, in the expanded state, the main body 113 is arched.
  • the proximal portion 111 and the distal portion 112 are connected by the main body portion 113.
  • the main body portion 113 can be arched to realize the expansion of the expandable cage 110, and the main body portion 113 functions as The role of support and defines the external mounting surface to facilitate the connection of the flexible wall 30.
  • the expandable cage 120 includes a proximal portion 121, a distal portion 122, and a hollow main body portion 123.
  • the proximal portion 121 and the distal portion 122 are disposed on the shaft 20 and can move relative to each other (the relative movement here includes the proximal end).
  • the part 121 and the distal part 122 move relative to the shaft 20 at the same time, or one of the proximal part 121 and the distal part 122 moves relative to the shaft 20);
  • the main body part 123 connects the proximal part 121 and the distal part 122 and
  • the external mounting surface is defined, and the flexible wall 30 is connected to the external mounting surface (as shown in FIG. 2).
  • the main body 123 is arranged around the shaft 20, and the main body 123 has a certain degree of toughness. When the proximal end 121 and the distal end 122 are close to each other, the main body 123 can be arched. When the expandable cage 120 is in a contracted state, the proximal end 121 and the distal end 122 are separated by a first distance, and when the expandable cage 120 is in an expanded state, the proximal end 121 and the distal end 122 are separated by a second distance, The second distance is smaller than the first distance, that is, in the expanded state, the main body 123 is arched.
  • the proximal portion 121 and the distal portion 122 are connected by the main body portion 123.
  • the main body portion 123 can be arched to realize the expansion of the expandable cage 120, and the main body portion 123 functions as The role of support and defines the external mounting surface to facilitate the connection of the flexible wall 30.
  • each of the main body portions 113 and 123 includes a plurality of branches.
  • the two ends of each branch of the main body 113 are respectively connected to the proximal part 111 and the distal part 112, and a plurality of branches are distributed around the shaft 20; the two ends of each branch of the main body 123 are respectively connected to the proximal part 121 and At the distal end 122, a plurality of branches are distributed around the shaft 20.
  • the main body parts 113 and 123 are composed of a plurality of branches, and the overall structure is simple, which is convenient for processing and manufacturing.
  • the main body portions 113 and 123 may also have a net-like structure or other irregular hollow structures, and the main body portions 113 and 123 of appropriate shapes are selected according to actual conditions.
  • the main body parts 113 and 123 are composed of a plurality of branches.
  • the proximal end 111 and the distal end 112 of the expandable cage body 110 are both sleeved on the shaft 20, and the proximal end 121 and the distal end 122 of the expandable cage body 120 are both sleeved on the shaft 20. ⁇ 20 on.
  • connection between the main body 113, 123 and the end can be a detachable connection, for example, a card slot is provided on the end, and the main body 113 and 123 are inserted into the slot and engaged with the end to facilitate the assembly and disassembly of the main body 113 and 123 and the end.
  • the connection between the main body portions 113 and 123 and the end portions may also be in a non-detachable connection manner, for example, welding or bonding.
  • the two expandable cage bodies 110 and 120 are arranged according to whether the axial direction is crossed or not, which may include two axial arrangements, refer to FIGS. 3 to 6. It should be noted that, for the purpose of clarity, FIGS. 3 to 6 are schematic diagrams of the expandable balloon device 100 with the flexible wall 30 omitted.
  • Axial arrangement mode one as shown in Figs. 3 and 4, the expandable cage body 110 and the expandable cage body 120 are arranged without crossing in the axial direction.
  • the non-intersecting arrangement of the two expandable cages 110 and 120 facilitates the installation of the two expandable cages 110 and 120 on the shaft 20.
  • Axial arrangement mode two as shown in Figures 5 and 6, the expandable cage body 110 and the expandable cage body 120 are arranged to cross in the axial direction, that is, the distal end 112 of the expandable cage body 110 is located on the expandable cage body 120 Between the proximal end 121 and the distal end 122 of the expandable cage 120, the proximal end 121 of the expandable cage 120 is located between the proximal end 111 and the distal end 112 of the expandable cage 110.
  • the two expandable cages 110, 120 are axially crossed, and the axial arrangement is compact.
  • the concave positions between the two expandable cages 110, 120 are concentrated during expansion, which is convenient for positioning in use; and the axial arrangement mode
  • the middle part of the expansion device composed of two expandable cages 110 and 120 has a larger radial expansion size during expansion, which is more conducive to the expansion of the narrow part.
  • the expandable cage body 110 and the expandable cage body 120 are arranged to cross each other in the axial direction.
  • the proximal end 111, the proximal end 121, the distal end 112 and the distal end 122 are first arranged on the shaft at intervals from the proximal end to the distal end.
  • the two ends of the flexible wall 30 are respectively connected to the main body 113 of the expandable cage 110 and the main body 123 of the expandable cage 120.
  • the assembly method in which the two expandable cages 110 and 120 axially cross is not the only one, and other assembly methods can also be used, as long as the two expandable cages 110 and 120 are arranged in an axially crossed manner.
  • the distal end 112 of the expandable cage 110 and the proximal end 121 of the expandable cage 120 may or may not be in contact.
  • one end of the expandable cage 110 is a fixed end fixed to the shaft 20, and the other end of the expandable cage 110 is a movable end that can move along the shaft 20;
  • One end of the expandable cage 120 is a fixed end fixed to the shaft 20, and the other end of the expandable cage 120 is a movable end that can move along the shaft 20.
  • the expandable cage 110 and the expandable cage 120 are both fixed at one end and movable at the other end. That is, when the expandable cages 110 and 120 are expanded or contracted, only one end moves relative to the shaft 20.
  • the two ends of the expandable cage body 110 and the two ends of the expandable cage body 120 may both be configured as moving ends that can move along the shaft 20.
  • both ends of the expandable cage body 110 and the two ends of the expandable cage body 120 move relative to the shaft 20.
  • the flexible wall 30 has a cylindrical structure arranged around the shaft 20 (as shown in FIG. 1), one end of the flexible wall 30 is connected to the outer mounting surface of the expandable cage 110, and the other One end is connected to the outer mounting surface of the expandable cage 120 (as shown in FIG. 2).
  • the cylindrical structure design of the flexible wall 30 allows the flexible wall 30 to fully contact the valve in the circumferential direction, and evenly and effectively transmits the expansion force to the stenosis part of the valve, facilitating the uniform force expansion of the valve.
  • the flexible wall 30 may also be a plurality of flexible belts (not shown) distributed around the shaft 20 at intervals. The flexible belts are arranged in parallel with the shaft 20, and the two ends of the flexible belt are respectively connected to the expandable cage body. 110 and the outer mounting surface of the expandable cage 120 are connected.
  • the mobile terminal it is divided into two expandable cages 110, 120.
  • the center distance of the two expandable cages 110, 120 changes (for example, Figure 14 )
  • the center distance remains unchanged (for example, Figure 15).
  • the material of the flexible wall 30 is not limited, and it can be a material with no elasticity or a material with a certain elasticity.
  • the flexible wall 30 may have elasticity to reduce the outer contour of the device when the device is collapsed under the condition of adapting to the center distance change.
  • the flexible wall 30 may not have elasticity.
  • the flexible wall 30 may be fabricated. The center distance between the two expandable cages 110, 120 is When changing, the flexible wall 30 unfolds or folds.
  • the center distance of the two expandable cages 110, 120 remains unchanged, and the flexible wall 30 is made of a non-elastic material.
  • the flexible wall 30 follows the contraction of the expandable cages 110 and 120 and folds radially without axial folding, and the flexible wall 30 follows the expansion of the expandable cages 110 and 120 to expand radially without stretching in the axial direction.
  • the center distance between the two expandable cages 110 and 120 remains unchanged, and the flexible wall 30 adopts an elastic material.
  • the flexible wall 30 can shrink radially without folding in the axial direction.
  • the flexible wall 30 may not be folded radially when it is radially contracted, that is, when the expandable cage bodies 110 and 120 are expanded, the flexible wall 30 is elastically deformed in the radial direction.
  • the center distance between the two expandable cages 110 and 120 becomes longer, and the flexible wall 30 is made of elastic material.
  • the flexible wall 30 can shrink radially without folding in the axial direction.
  • the flexible wall 30 may not be folded radially when it is radially contracted.
  • the flexible wall 30 is elastically deformed in both the axial direction and the radial direction. At this time, the outer contour of the expansion balloon device 100 in the case of collapse is further reduced.
  • the center distance between the two expandable cages 110 and 120 becomes longer, and the flexible wall 30 is made of a non-elastic material.
  • the flexible wall 30 folds or collapses in the axial and radial directions; when the expandable cages 110 and 120 expand, the flexible wall 30 expands inelastically in the axial and radial directions.
  • a rigid support 31 is provided on the flexible wall 30, which can enhance the rigidity of the flexible wall 30 and facilitate the expansion of the narrow part.
  • the two ends of the rigid support 31 are connected to the two ends of the flexible wall 30.
  • the rigid support 31 is provided on the inner surface of the flexible wall 30 or embedded in the flexible wall 30.
  • the rigid support 31 may be displaced relative to the stenosis lesion.
  • the rigid support 31 is arranged on the inner surface of the flexible wall 30 or embedded in the flexible wall 30 to prevent the rigid support 31 Abrasive tissue.
  • the flexible wall 30 includes two wall films (not shown in the figure), and an accommodation space (not shown in the figure) is formed between the two wall films. ,
  • the rigid support 31 is accommodated in the accommodating space; the two ends of the two wall films are fixedly connected to form a closed accommodating space, so as to prevent the rigid support 31 from detaching.
  • the rigid support 31 may be an axial rigid support 311.
  • the rigid support 31 is an axial rigid support 311
  • the expandable cage bodies 110 and 120 are contracted, the plurality of axial rigid supports 311 are gathered toward the shaft 20.
  • the axially rigid support 311 is suitable for the case where the center distance of the two expandable cages 110 and 120 is constant during expansion, and is also suitable for the case where the center distance of the two expandable cages 110 and 120 changes during the expansion.
  • the axial rigid support 311 may be either a stretchable shaft-shaped member or a non-stretchable shaft-shaped member.
  • the center distance between the two expandable cages 110 and 120 becomes longer, and the axial rigid support 311 adopts a stretchable shaft-shaped component.
  • the two ends of the axial rigid support 311 are fixedly connected to the flexible wall 30.
  • the flexible wall 30 can drive the axial rigid support 311 to achieve axial stretching or contraction.
  • the rigid support 31 is a stretchable structure that can be extended with the expansion of the two expandable cages 110, 120, and contracted with the contraction of the two expandable cages 110, 120, and provides further expansion for the narrow part when expanded Supporting force, saving space and reducing the volume of the device when shrinking.
  • the center distance between the two expandable cages 110 and 120 becomes longer, and the axial rigid support 311 adopts a non-stretchable shaft-like component.
  • the flexible wall 30 includes a three-section structure sequentially distributed along the axial direction.
  • the first section and the third section at both ends are elastic structures.
  • the first section and the third section are connected to the expandable cage body 110 and the expandable cage respectively.
  • the body 120 is connected, and the second section in the middle has a structure that does not have elasticity.
  • the axial rigid support 311 adopts a non-stretchable shaft-shaped member.
  • the axial rigid support 311 is connected to the second section, and the axial rigid support 311 is connected to the second section.
  • the ends extend to the first and third sections.
  • the flexible wall 30 is made of elastic material as a whole, and the axial rigid support 311 is a non-stretchable shaft-shaped member, and the axial rigid support 311 is connected to the flexible wall 30 through at least two connection points on the flexible wall 30, wherein , The connection points are distributed at intervals along the axial direction, and the axial rigid support 311 is slidingly fitted with at least one connection point.
  • a fixed connection point and at least one movable connection point are provided on the flexible wall 30. The fixed connection point is located at one end of the flexible wall 30, and one end of the axial rigid support 311 is fixedly connected to the fixed connection point.
  • the rigid support 311 is slidably fitted with at least one movable connection point of the flexible wall 30; in another embodiment, a fixed connection point is provided in the middle of the flexible wall 30, and the axial rigid support 311 is fixedly connected to the fixed connection point.
  • the wall 30 is also provided with at least two movable connection points, the at least two movable connection points are located on both sides of the fixed connection point, and the axial rigid support 311 is slidingly fitted with the at least two movable connection points.
  • the rigid support 31 may be a spiral rigid support 312.
  • the spiral rigid support 312 is spirally distributed on the flexible wall 30.
  • the spiral rigid support 312 is suitable for the case where the center distance of the two expandable cages 110 and 120 is constant during expansion, and is also suitable for the case where the center distance of the two expandable cages 110 and 120 changes during the expansion.
  • the two ends of the spiral rigid support 312 are fixedly connected to the two ends of the flexible wall 30.
  • the spiral rigid support 312 can be a stretchable structure (similar to a spring shape, which can achieve axial and radial deformation), or Non-stretchable structure.
  • the center distance between the two expandable cages 110 and 120 becomes longer, and the spiral rigid support 312 adopts a stretchable spiral component.
  • the two ends of the spiral rigid support 312 are fixedly connected to the two ends of the flexible wall 30.
  • the spiral rigid support 312 is made of a material with a certain degree of toughness.
  • the spiral rigid support 312 produces axial and radial expansion at the same time as the flexible wall 30 expands. (The axial length and diameter become larger at the same time), the helical rigid support 312 follows the contraction of the flexible wall 30 and simultaneously produces axial and radial contraction (the axial length and diameter decrease at the same time).
  • the center distance of the two expandable cages 110 and 120 remains unchanged when the expandable balloon device 100 is expanded, and the spiral rigid support 312 adopts a stretchable spiral component.
  • the two ends of the spiral rigid support 312 are fixedly connected to the two ends of the flexible wall 30.
  • the spiral rigid support 312 is made of a material with a certain degree of toughness.
  • the spiral rigid support 312 follows the expansion of the flexible wall 30 to produce radial expansion (the diameter becomes larger And the axial length is unchanged), the spiral rigid support 312 follows the contraction of the flexible wall 30 to produce radial contraction (the diameter becomes smaller and the axial length remains unchanged).
  • the rigid support 31 when the rigid support 31 adopts non-stretchable parts (for example, the axial rigid support 311 and/or the spiral rigid support 312), the rigid support 31 may be provided on the flexible wall 30
  • the surface of the rigid support 31 is in direct contact with the tissue; the rigid support 31 can also be a sleeve (not shown in the figure, the sleeve can be elastic or inelastic), and the sleeve is sleeved outside the rigid support 31.
  • the rigid support 31 uses a sleeve, the rigid support 31 can be prevented from directly contacting the tissue.
  • the expansion balloon device 100 is expanded or contracted, the rigid support 31 will not cause tissue trauma.
  • the sleeve is set to be elastic, and the elastic sleeve follows the expansion or contraction of the flexible wall 30 to generate elastic deformation.
  • the expandable balloon device 100 further includes a membrane 40.
  • the membrane 40 can be arranged on the expandable cage 110, or on the expandable cage 120, or on both of them at the same time. Expandable cage body 110,120.
  • the membrane 40 may be arranged at the proximal end or the distal end of the expandable cage 110, or may be arranged at the proximal end or the distal end of the expandable cage 120.
  • the membrane 40 is arranged at the proximal end of the expandable cage 110 or the distal end of the expandable cage 120.
  • the membrane 40 is arranged in the hemisphere of the expandable cage 120 at the distal end (the hemisphere refers to the expanded state of the expandable cage 120), and the membrane 40 can be The expansion forms the hemispherical thin wall when the expandable cage 120 expands to the maximum.
  • the membrane 40 and the expandable cage 120 may be fixed at intervals, continuously or partially continuously.
  • the membrane 40 and the expandable cage 120 are spaced and fixed, that is, the membrane 40 and the main body 123 have multiple fixed points in the circumferential direction, and the multiple fixed points are distributed at intervals.
  • the main body portion 123 adopts a structure of multiple branches, the multiple branches are distributed around the shaft 20, the two ends of each branch are respectively connected to the proximal part 121 and the distal part 122, and the membrane 40 is spaced from the multiple branches. Fixed connection (spaced one or more branches).
  • the membrane 40 allows blood to flow from the distal end 122 of the expandable cage 120 to the proximal end 121 and prevents blood from flowing from the proximal end 121 of the expandable cage 120 to the distal end 122.
  • the structure and installation position of the membrane 40 can adopt the cover scheme in the patent publication number CN101959478B, that is, the membrane 40 is arranged outside the proximal end of the expandable cage 110, and the membrane 40 is at least partially Surrounding the proximal end of the expandable cage 110, the membrane 40 includes at least one slit and is at least partially separated from the outer surface of the main body portion 113 at the proximal end portion.
  • a plurality of slits may be distributed on the membrane 40 at approximately 120 degrees at the proximal end portion. superior.
  • the proximal part of the membrane 40 is sewn to define a plurality of leaflets.
  • the leaflets When blood flows through the expandable cage 110 from the distal end to the proximal end, the leaflets can open the blood flow channel, and when the blood tries to flow from the proximal end to the distal end When passing the expandable cage 110, the leaflets can close the blood flow channel.
  • the membrane 40 is contracted or expanded by the blood flow force, and the setting of the membrane 40 limits the unidirectional blood flow to prevent reflux.
  • the membrane 40 is unfolded to close the blood flow channel; as shown in FIGS. 10 and 12, the membrane 40 is folded to open the blood flow channel.
  • the membrane 40 is in contact with all the main body parts 123 of the expandable cage 120, and the membrane 40 closes the blood flow channel and blocks blood reflux, as shown in FIGS. 11 and 13.
  • the expansion balloon device 100 further includes a drive wire 50.
  • the drive line 50 is connected to the moving end of the expandable cage 110 and the moving end of the expandable cage 120, and the drive line 50 is configured to control the moving end of the expandable cage 110 and the expandable cage.
  • the movable end of the body 120 moves, thereby facilitating the expansion of the expandable cage bodies 110 and 120.
  • the movement of the moving end of the expandable cage 110 and the moving end of the expandable cage 120 is controlled by the drive line 50, which is convenient to realize the control of the expansion of the two expandable cages 110, 120, and the operation is convenient.
  • the drive line 50 may be provided with two branches.
  • the expandable cage bodies 110 and 120 only need to be provided with one moving end, and the two branch drive lines correspond to the expandable cages.
  • Each branch drive line corresponding to the moving end of the body 110 and the moving end of the expandable cage 120 drives one expandable cage, so as to realize the simultaneous expansion or asynchronous expansion of the two expandable cages 110 and 120.
  • the drive line 50 can also be provided with three or four branches. At this time, three or four of the four ends of the two expandable cages 110 and 120 are set as moving ends, and each branch drive line drives one to move.
  • Each branch drive line drives the corresponding mobile end to move, so as to realize the expansion or contraction of the expandable cages 110 and 120.
  • a locking member (not shown in the figure) is provided at the proximal end of the shaft 20 or the user's operating end, and the locking member is configured to be driven by the drive line 50 After the two expandable cages 110, 120 are expanded to the expanded state, the drive line 50 is locked to ensure that the two expandable cages 110, 120 are locked in the expanded state.
  • the driving wire 50 includes a main body 51, a first branch 52, and a second branch 53, one end of the first branch 52 is connected to the main body 51, and the first branch 52 The other end is connected to the moving end of the expandable cage body 110, one end of the second branch 53 is connected to the main body 51, and the other end of the second branch 53 is connected to the moving end of the expandable cage body 120.
  • the main body 51 is connected to the first branch 52 and the second branch 53, and by controlling the movement of the main body 51, the movement control of the moving ends of the two expandable cages 110, 120 is realized, and the movement of the two expandable cages 110, 120 is realized. Expansion or contraction.
  • FIGS. 14 and 15 are both schematic diagrams of the expansion balloon device 100 with the flexible wall 30 omitted.
  • FIG. 14 schematically shows the connection details of the drive line 50 with a longer center distance between the expandable cage 110 and the expandable cage 120 during the expansion and contraction of the expandable balloon device 100.
  • the proximal end 111 of the expandable cage 110 is the fixed end, and the distal end 112 of the expandable cage 110 is the mobile end; the proximal end 121 of the expandable cage 120 is the mobile end, and the distal end of the expandable cage 120
  • the part 122 is a fixed end; the distal end 122 of the expandable cage 120 is provided with a first wire-passing hole (not shown in the figure), the first wire-passing hole is for the second branch 53 to pass through; the second branch 53 is far away
  • One end of the main body 51 passes through the first wire-passing hole and is connected to the proximal end 121 of the expandable cage 120.
  • the distal end 122 of the expandable cage 120 functions as a fulcrum to facilitate the support of the second branch 53.
  • the driving wire 50 can control the distal end 112 of the expandable cage 110 and the proximal end 121 of the expandable cage 120 to move in opposite directions, so as to realize the expansion or contraction of the two expandable cages 110 and 120.
  • the driving wire 50 is pulled to move proximally, the distal end 112 of the expandable cage 110 moves proximally, and the proximal end 121 of the expandable cage 120 moves distally, and the expandable balloon device 100 expands.
  • the distal end 112 of the expandable cage 110 moves distally, and the proximal end 121 of the expandable cage 120 moves proximally, and the expandable balloon device 100 contracts.
  • the proximal end 111 of the expandable cage 110 and the distal end 122 of the expandable cage 120 are fixed ends, so that when the expandable cages 110 and 120 are expanded, the distal end 112 of the expandable cage 110 and the expandable
  • the proximal end 121 of the cage 120 moves in the opposite direction, so as to ensure that both ends of the flexible wall 30 are pulled and expanded synchronously.
  • the occupied length of the expansion balloon device 100 composed of two expandable cages 110 and 120 on the shaft 20 does not change.
  • FIG. 15 schematically shows the connection details of the drive line 50 with a constant center distance between the expandable cage 110 and the expandable cage 120 during the expansion and contraction of the expandable balloon device 100.
  • the difference is that the proximal end 121 of the expandable cage 120 is a fixed end, the distal end 122 of the expandable cage 120 is a mobile end, and the second branch 53 is directly connected to the expandable cage 120.
  • the distal end 122 is connected.
  • the driving wire 50 is pulled to move proximally, the distal end 112 of the expandable cage 110 and the distal end 122 of the expandable cage 120 both move proximally, and the expandable balloon device 100 expands.
  • the slack drive wire 50, the distal end 112 of the expandable cage 110 and the distal end 122 of the expandable cage 120 all move to the distal end, and the expandable balloon device 100 contracts.
  • the proximal end 111 of the expandable cage 110 and the proximal end 121 of the expandable cage 120 are both fixed ends.
  • the distal end 112 of the expandable cage 110 and the expandable moves toward the respective proximal end, and the length of the expansion balloon device 100 composed of two expandable cages 110 and 120 on the shaft 20 is reduced.
  • the fixed end of the first expandable cage 110 is provided with a second wire passing hole (not shown in the figure). ⁇ ), the main body 51 is inserted into the second cable-passing hole.
  • the proximal end 111 of the expandable cage 110 is a fixed end
  • the proximal end 111 of the expandable cage 110 is provided with a first mounting seat 540
  • the second cable hole is opened in the first
  • the main body 51 passes through the second cable hole on the first mounting seat 540 and can move relative to the proximal end 111 of the expandable cage body 110, thereby driving the first branch 52 and the second branch 53 to be relatively ⁇ 20 Moves.
  • the distal end 112 of the expandable cage body 110 is provided with a second mounting seat 541
  • the proximal end 121 of the expandable cage body 120 is provided with a third mounting seat 542.
  • the distal end 122 of the body 120 is provided with a fourth mounting seat 543.
  • the fourth mounting seat 543 is provided with a first cable-passing hole, and the second branch 53 passes through the first cable-passing hole and is connected to the third mounting seat 542; in order to avoid the first branch 52 and the second branch 53 interference, the second mounting seat 541 on the distal end 112 of the expandable cage body 110 is located below the shaft 20, and the third mounting seat 542 on the proximal end 121 of the expandable cage body 120 is located above the shaft 20; at the same time; , Under the shaft 20, the second branch 53 is located under the first branch 52 to avoid interference between the first branch 52 and the second branch 53.
  • the first cable-passing hole can extend in a direction perpendicular to the shaft 20; the first cable-passing hole can also be an arc-shaped hole, which extends around the circumference of the shaft 20, and the two ports of the first cable-passing hole are located in the center of the shaft 20 Both sides of the line.
  • the proximal end 121 of the expandable cage 120 is not connected to the second branch 53, so the proximal end 121 may not be provided with a mounting seat.
  • the two moving ends for example, the distal ends 112 and 122
  • the mobile terminal makes the two mobile terminals move synchronously.
  • the expansion balloon device 100 further includes a multi-lumen tube 60 and an overtube 70.
  • the multi-lumen tube 60 is located at the proximal end of the shaft 20 relative to the expandable cage 110 and the expandable cage 120. As shown in FIG. 17, the multi-lumen tube 60 is provided with a first lumen 61 and a second lumen 62. The proximal end of 20 passes through the first cavity 61, and the proximal end of the drive wire 50 passes through the second cavity 62. The driving wire 50 can move relative to the multi-lumen tube 60 to realize the movement control of all the moving ends of the two expandable cages 110 and 120.
  • the first lumen 61 and the second lumen 62 of the multi-lumen tube 60 accommodate the shaft 20 and the drive wire 50 respectively, so that the drive wire 50 can move flexibly relative to the shaft 20 and play a role of guiding and supporting the drive wire 50.
  • the outer sleeve 70 is slidably sleeved on the multi-lumen tube 60.
  • the outer sleeve 70 can move relative to the multi-lumen tube 60 to connect the two expandable cages 110, 120 120 is housed in the outer sleeve 70.
  • the entire expansion balloon device 100 it is convenient for the entire expansion balloon device 100 to move in a duct (for example, a blood vessel).
  • the drive line 50 can control the expansion or contraction of the two expandable cages 110, 120.
  • the distal end of the shaft 20 is provided with a guiding and limiting portion 21, and the distal end of the guiding and limiting portion 21 is set in an arrow-like shape to facilitate the shaft 20 to move in the pipe.
  • the size of the guide limiting portion 21 is greater than the diameter of the shaft 20, and the distal end 122 of the expandable cage 120 is restricted to prevent the expandable cage 120 from being separated from the shaft 20 at the distal end.
  • the working principle of the expansion balloon device 100 according to the embodiment of the present disclosure is:
  • the two expandable cages 110, 120 and the flexible wall 30 are arranged on the shaft 20 in the axial direction (the membrane 40 has been installed on the expandable cage 120), and the flexible wall 30 is located on the two expandable cages 110, 120, the two ends of the flexible wall 30 are respectively connected to the two expandable cages 110, 120;
  • the shaft 20 is inserted into the first lumen 61 of the multi-lumen tube 60, and the far end of the drive line 50
  • the end is connected with the moving ends of the two expandable cages 110 and 120, the proximal end of the driving wire 50 is inserted into the second lumen 62 of the multi-lumen tube 60; the outer sleeve 70 is sleeved outside the multi-lumen tube 60.
  • the shaft 20 and the two expandable cages 110, 120 are sent to the desired position, so that the two expandable cages 110, 120 are exposed from the outer sleeve 70, and the two expandable cages 110 are controlled by the drive line 50 , 120 expansion or contraction.
  • a recess is always formed between the two expandable cages 110, 120, which facilitates the positioning of the stenosis during expansion; the two expandable cages 110, 120
  • the expansion force of 120 is enhanced; the adhesion between the flexible wall 30 and the valve is enhanced, which is more conducive to the expansion of the valve.
  • the expansion balloon device 100 disclosed herein can be used for the expansion of other stenosis lesions, and can also be used for prosthetic valves. Expansion during deployment.
  • the expandable balloon device 100 disclosed herein can be configured to replace expandable balloon elements in many types of medical procedures.
  • the expandable balloon device 100 described herein can be used in, for example, angioplasty (e.g., opening of an infarcted coronary artery), valvuloplasty (e.g., expansion of a stenotic heart valve), and other procedures that conventionally employ expanding balloon elements.
  • angioplasty e.g., opening of an infarcted coronary artery
  • valvuloplasty e.g., expansion of a stenotic heart valve

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Abstract

一种扩张球囊装置（100）及扩张球囊装置（100）的制作方法。扩张球囊装置（100）包括轴（20）、两个可扩笼形体（110，120）及柔性壁（30），两个可扩笼形体（110，120）沿轴向设置于轴（20）上，每个可扩笼形体（110，120）均具有收缩状态和扩张状态；柔性壁（30）与两个可扩笼形体（110，120）连接，柔性壁（30）至少部分包围两个可扩笼形体（110，120）之间的凹部，柔性壁（30）可随可扩笼形体（110，120）的扩张而扩张。在两个可扩笼形体（110，120）扩张的过程中，两个可扩笼形体（110，120）中间始终形成凹部，有利于扩张狭窄瓣膜时对狭窄部位的定位；两个可扩笼形体（110，120）共同提供扩张力，使得扩张力增强，利于扩张；另外，柔性壁（30）使得扩张球囊装置（100）与狭窄部位的贴附性增强，降低因扩张球囊装置（100）机械扩张而造成瓣膜创伤的概率。

Description

扩张球囊装置及扩张球囊装置的制作方法
相关申请的交叉引用
本公开要求于2020年5月29日提交中国专利局、申请号为CN202010479562.4、发明名称为“扩张球囊装置及扩张球囊装置的制作方法”的中国专利申请的优先权，其全部内容通过引用结合在本公开中。
技术领域
本公开涉及医疗器械技术领域，具体而言，涉及扩张球囊装置及扩张球囊装置的制作方法。
背景技术
在医疗程序中广泛地使用可胀大的结构，例如，球囊。在球囊到达关注的区域之前，球囊典型地放置于导管的端部内。当球囊到达关注的区域时，球囊从导管中释放出，向球囊中输注填充介质使球囊胀大。
球囊可以配置成心脏瓣膜治疗手术中，包括在主动脉球囊瓣膜成形术(BAV)和经导管主动脉瓣植入术(TAVI)期间。球囊可以配置成预扩狭窄的瓣膜部位以方便假体瓣膜的置入，也可以配置成假体瓣膜置入部署时扩张初始皱缩的假体瓣膜。现有球囊包括气球式球囊和非气球式的镂空球囊，CN101959478B公开了一种可应用于TAVI的镂空球囊，所述镂空球囊由单个可扩笼形体组成，扩张力有限；所述球囊主要配置成假体瓣膜置入部署时扩张初始皱缩的假体瓣膜，扩张时球囊中段外凸，若将该球囊用于狭窄部位的预扩，定位性和贴附性不佳。
发明内容
根据本公开的各种实施例，目的在于提供扩张球囊装置及扩张球囊装置的制作方法。
本公开提供扩张球囊装置，包括：
轴；
两个可扩笼形体，两个可扩笼形体沿轴向设置于轴上，每个可扩笼形体均具有收缩状态和扩张状态；
柔性壁，柔性壁与两个可扩笼形体连接，柔性壁至少部分包围两个可扩笼形体之间的凹部，柔性壁可随可扩笼形体的扩张而扩张。
本公开还提供扩张球囊装置的制作方法，制作方法包括：
将第一可扩笼形体的近端部、第二可扩笼形体的近端部、第一可扩笼形体的远端部及第二可扩笼形体的远端部由近端到远端间隔设置于轴上；
将第一可扩笼形体的主体部一端与第一可扩笼形体的远端部连接，将第二可扩笼形体的主体部的一端与第二可扩笼形体的近端部连接，然后将第二可扩笼形体的主体部与第一可扩笼形体的主体部交叉；
将第二可扩笼形体的主体部的另一端与第二可扩笼形体的远端部连接，将第一可扩笼形体 的主体部的另一端与第一可扩笼形体的近端部连接，完成两个可扩笼形体的轴向交叉装配；
将柔性壁的两端分别连接于第一可扩笼形体的主体部和第二可扩笼形体的主体部。
本公开的一个或多个实施例的细节、附加方面和优点将在下面的描述中部分给出，部分将从下面的描述中变得明显，或通过本公开的实践了解到。
附图说明
为了更清楚地说明本公开实施例的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，应当理解，以下附图仅示出了本公开的某些实施例，因此不应被看作是对范围的限定，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相关的附图。
图1为本公开实施例提供的扩张球囊装置的爆炸图；
图2为本公开实施例提供的扩张状态下的扩张球囊装置的主视图；
图3为本公开实施例提供的扩张状态下且隐藏了柔性壁的两个可扩笼形体轴向不交叉布置的扩张球囊装置的主视图；
图4为本公开实施例提供的收缩状态下且隐藏了柔性壁的两个可扩笼形体轴向不交叉布置的扩张球囊装置的主视图；
图5为本公开实施例提供的扩张状态下且隐藏了柔性壁的两个可扩笼形体轴向交叉布置的扩张球囊装置的主视图；
图6为本公开实施例提供的收缩状态下且隐藏了柔性壁的两个可扩笼形体轴向交叉布置的扩张球囊装置的主视图；
图7为本公开实施例提供的扩张球囊装置的可扩笼形体的结构示意图；
图8为本公开实施例提供的设置轴向刚性支撑件的扩张球囊装置的主视图；
图9为本公开实施例提供的设置螺旋刚性支撑件的扩张球囊装置的主视图；
图10为本公开实施例提供的膜在折叠状态的扩张球囊装置的立体图(血流通道打开状态)；
图11为本公开实施例提供的膜在展开状态的扩张球囊装置的立体图(血流通道关闭状态)；
图12为扩张球囊装置的端视图(血流通道打开状态，显示膜与第二可扩笼形体的装配关系)；
图13为扩张球囊装置的再一端视图(血流通道关闭状态，显示膜与第二可扩笼形体的装配关系)；
图14为本公开实施例提供的扩张球囊装置的驱动线与两个可扩笼形体的一种连接示意图；
图15为本公开实施例提供的扩张球囊装置的驱动线与两个可扩笼形体的又一种连接示意图；
图16为本公开实施例提供的扩张球囊装置的多腔管和外套管的结构示意图；
图17为本公开实施例提供的扩张球囊装置的多腔管的剖视图。
图标：100-扩张球囊装置；110-可扩笼形体；111-近端部；112-远端部；113-主体部；120-可扩笼形体；121-近端部；122-远端部；123-主体部；20-轴；21-导向限位部；30-柔性壁；31-刚性支撑件；311-轴向刚性支撑件；312-螺旋刚性支撑件；40-膜；50-驱动线；51-主体；52-第一分支；53-第二分支；540-第一安装座；541-第二安装座；542-第三安装座；543-第四安装座；60-多腔管；61-第一腔道；62-第二腔道；70-外套管。
具体实施方式
为使本公开实施例的目的、技术方案和优点更加清楚，下面将结合本公开实施例中的附图，对本公开实施例中的技术方案进行清楚且完整地描述，显然，所描述的实施例是本公开一部分实施例，而不是全部的实施例。通常在此处附图中描述和示出的本公开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公开的实施例的详细描述并非旨在限制要求保护的本公开的范围，而是仅仅表示本公开的选定实施例。基于本公开中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本公开保护的范围。
应注意到：相似的标号和字母在下面的附图中表示类似项，因此，一旦某一项在一个附图中被定义，则在随后的附图中不需要对其进行进一步定义和解释。
在本公开的描述中，需要说明的是，术语“内”和/或“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，或者是该申请产品使用时惯常摆放的方位或位置关系，仅是为了便于描述本公开和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本公开的限制。此外，术语“第一”、“第二”等仅用于区分描述，而不能理解为指示或暗示相对重要性。
在本公开的描述中，还需要说明的是，除非另有明确的规定和限定，术语“设置”和/或“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本公开中的具体含义。
下面参考附图描述根据本公开第一方面实施例的扩张球囊装置100。
如图1和图2所示，根据本公开实施例的扩张球囊装置100，包括：轴20、两个可扩笼形体(镂空球囊)110、120以及柔性壁30。
轴20配置成安装两个可扩笼形体110、120。两个可扩笼形体110、120沿轴向设置于轴20上，两个可扩笼形体110、120同轴设置。可扩笼形体110、120均具有收缩状态和扩张状态，可扩笼形体110、120能够以轴20为中心放射状地向外扩张。两个可扩笼形体110、120在扩张过程中，两个可扩笼形体110、120之间始终形成凹部。柔性壁30与两个可扩笼形体110、120连接，柔性壁30至少部分包围两个可扩笼形体110、120之间的凹部。柔性壁30能够随可扩笼形体110、120的扩张而扩张，当柔性壁30跟随可扩笼形体110、120扩张后，柔 性壁30与瓣膜狭窄部位贴附并逐渐撑开原生的狭窄瓣膜，实现整个装置的定位，同时便于扩张力的有效传递。
根据本公开实施例的扩张球囊装置100，两个可扩笼形体110、120与柔性壁30形成一个有机整体，在两个可扩笼形体110、120扩张的过程中，两个可扩笼形体110、120中间始终形成凹部，有利于瓣膜扩张时定位。两个可扩笼形体110、120共同提供扩张力，使得扩张力增强，明显大于一个可扩笼形体的扩张力，从而提高狭窄扩张效率。另外，柔性壁30直接接触待扩张的狭窄部位，其材质相对于金属球囊直接接触狭窄部位时，降低了因扩张球囊装置100机械扩张而造成组织创伤的概率；柔性壁30直接接触待扩张的狭窄部位，其接触面积相对于金属球囊直接接触瓣膜时有所增加，贴附性增强，更能将可扩笼形体110、120的扩张力有效传递到狭窄部位，有利于扩张。
下面参照附图描述根据本公开实施例的扩张球囊装置100的各部件的结构特征及连接方式。
如图3-图6所示，两个可扩笼形体110、120沿轴向设置于轴20上，其中图3和图4为两个可扩笼形体110、120沿轴向不交叉布置示意图，图5和图6为两个可扩笼形体110、120沿轴向交叉布置示意图。
根据本公开的一些实施例，可扩笼形体110、120的材料可以为镍钛合金(NiTi)、不锈钢等，具有一定的支撑强度。柔性壁30的材料可以为不带弹性的材料，例如织布、膨化聚四氟乙烯，也可以为带一定弹性的材料，例如橡胶或硅胶。轴20的材质可以为不锈钢，具有一定的支撑强度。在本公开的其他实施方式中，可扩笼形体110、120和轴20的材料还可以为其他金属材料、合金材料或非金属硬质材料等。
根据本公开的一些实施例，如图7所示，可扩笼形体110位于近端，可扩笼形体120位于远端。本公开中，定义靠近操作者一端为近端，远离操作者一端为远端。具体地，图7中左端为近端，右端为远端。
可扩笼形体110包括近端部111、远端部112及镂空的主体部113，近端部111和远端部112设置在轴20上且可相对彼此移动(这里的相对彼此移动包括近端部111和远端部112同时相对于轴20移动，或者，近端部111和远端部112中的一者相对于轴20移动)；主体部113连接近端部111和远端部112且限定外部安装表面，柔性壁30连接于外部安装表面(如图2所示)。主体部113围绕轴20设置，主体部113具有一定的韧性，在近端部111和远端部112相互彼此靠近时，主体部113能够拱起。当可扩笼形体110处于收缩状态时，近端部111和远端部112相距第一距离，当可扩笼形体110处于扩张状态时，近端部111和远端部112相距第二距离，第二距离小于第一距离，也即在扩张状态时，主体部113拱起。
通过主体部113连接近端部111和远端部112，在近端部111和远端部112彼此靠近时，主体部113能够拱起以实现可扩笼形体110的扩张，主体部113起到支撑的作用，并且限定外 部安装表面，以便于柔性壁30的连接。
可扩笼形体120包括近端部121、远端部122及镂空的主体部123，近端部121和远端部122设置在轴20上且可相对彼此移动(这里的相对彼此移动包括近端部121和远端部122同时相对于轴20移动，或者，近端部121和远端部122中的一者相对于轴20移动)；主体部123连接近端部121和远端部122且限定外部安装表面，柔性壁30连接于外部安装表面(如图2所示)。主体部123围绕轴20设置，主体部123具有一定的韧性，在近端部121和远端部122相互彼此靠近时，主体部123能够拱起。当可扩笼形体120处于收缩状态时，近端部121和远端部122相距第一距离，当可扩笼形体120处于扩张状态时，近端部121和远端部122相距第二距离，第二距离小于第一距离，也即在扩张状态时，主体部123拱起。
通过主体部123连接近端部121和远端部122，在近端部121和远端部122彼此靠近时，主体部123能够拱起以实现可扩笼形体120的扩张，主体部123起到支撑的作用，并且限定外部安装表面，以便于柔性壁30的连接。
在一些实施方式中，主体部113、123均包括多个支条。主体部113的每个支条的两端分别连接近端部111和远端部112，多个支条围绕轴20分布；主体部123的每个支条的两端分别连接近端部121和远端部122，多个支条围绕轴20分布。主体部113、123由多个支条构成，整体结构简单，便于加工制造。在本公开的其他实施方式中，主体部113、123还可以为网状结构，或者其他非规则镂空结构，根据实际情况选取合适形状的主体部113、123。在本公开中优选地实施方式是主体部113、123由多个支条构成。
作为本公开的可选方式，可扩笼形体110的近端部111和远端部112均套设于轴20上，可扩笼形体120的近端部121和远端部122均套设于轴20上。主体部113、123与端部(近端部111、121和远端部112、122的统称，下同)的连接可以为可拆卸的连接方式，例如，端部上设置有卡槽，主体部113、123插设于卡槽内并与端部卡合，以便于主体部113、123与端部的装配与拆卸。主体部113、123与端部的连接也可以为不可拆卸的连接方式，例如，焊接或粘接。
根据本公开的一些实施例，两个可扩笼形体110、120按轴向是否交叉布置，可包括两种轴向设置方式，参考图3-图6。需要注意的是，为了清晰目的，图3-图6均为省略了柔性壁30的扩张球囊装置100的示意图。
轴向设置方式一，如图3和图4所示，可扩笼形体110和可扩笼形体120沿轴向不交叉设置。两个可扩笼形体110、120的不交叉设置，便于两个可扩笼形体110、120在轴20上的安装。
轴向设置方式二，如图5和图6所示，可扩笼形体110和可扩笼形体120沿轴向交叉设置，即，可扩笼形体110的远端部112位于可扩笼形体120的近端部121和远端部122之间，可扩笼形体120的近端部121位于可扩笼形体110的近端部111和远端部112之间。两个可扩笼形 体110、120轴向交叉，轴向布置紧凑，在膨胀时两个可扩笼形体110、120之间的内凹位置集中，便于在使用中进行定位；与轴向设置方式一相比，两个可扩笼形体110、120构成的扩张装置的中部在膨胀时径向扩张尺寸更大，从而更有利于狭窄部位的扩张。在本公开中优选的实施方式是可扩笼形体110和可扩笼形体120沿轴向交叉设置。
当两个可扩笼形体110、120采用轴向交叉布置时，先将近端部111、近端部121、远端部112及远端部122由近端到远端间隔设置于轴上，然后将可扩笼形体110的主体部113一端与可扩笼形体110的远端部112连接，再将可扩笼形体120的主体部123的一端与可扩笼形体120的近端部121连接，并将可扩笼形体120的主体部123与可扩笼形体110的主体部113交叉，将可扩笼形体120的主体部123的另一端与可扩笼形体120的远端部122连接，最后再将可扩笼形体110的主体部113的另一端与可扩笼形体110的近端部111连接，实现两个可扩笼形体110、120的轴向交叉装配。完成两个可扩笼形体110、120的轴向交叉装配后，将柔性壁30的两端分别与可扩笼形体110的主体部113和可扩笼形体120的主体部123连接。需要注意的是，两个可扩笼形体110、120轴向交叉的装配方法并非唯一，还可以采用其他装配方法，只要实现两个可扩笼形体110、120的轴向交叉布置即可。
需要指出的是，当可扩笼形体110和可扩笼形体120轴向不交叉时，可扩笼形体110的远端部112与可扩笼形体120的近端部121可接触或不接触。
在根据本公开的一些具体实施例中，可扩笼形体110的一个端部为固定于轴20的固定端，可扩笼形体110的另一个端部为可沿轴20移动的移动端；可扩笼形体120的一个端部为固定于轴20的固定端，可扩笼形体120的另一个端部为可沿轴20移动的移动端。相当于，可扩笼形体110和可扩笼形体120均为一端固定且另一端活动的结构，也即在可扩笼形体110、120扩张或收缩时，只有一个端部相对于轴20移动。在本公开的其他实施方式中，可扩笼形体110的两个端部、可扩笼形体120的两个端部可以都设置为可沿轴20移动的移动端，在两个可扩笼形体110、120扩张或收缩时，可扩笼形体110的两个端部以及可扩笼形体120的两个端部均相对于轴20移动。
根据本公开的一些实施例，柔性壁30呈环绕轴20设置的筒状结构(如图1所示)，柔性壁30的一端连接于可扩笼形体110的外部安装表面，柔性壁30的另一端连接于可扩笼形体120的外部安装表面(如图2所示)。柔性壁30的筒状结构设计，使得柔性壁30的周向可与瓣膜充分接触，均匀有效地将扩张力传递给瓣膜狭窄部位，便于瓣膜均匀受力扩张。在本公开的其他实施方式中，柔性壁30还可以为围绕轴20间隔分布的多个柔性带(未示出)，柔性带与轴20平行设置，柔性带的两端分别与可扩笼形体110和可扩笼形体120的外部安装表面连接。
需要指出的是，根据移动端的设置位置及设置数量不同，分为两个可扩笼形体110、120在扩张和收缩过程中，两个可扩笼形体110、120的中心距变化(例如图14)和中心距保持不 变(例如图15)两种情况。
在两个可扩笼形体110、120的中心距不变的情况下，柔性壁30的材料不作限定，既可以选不带弹性的材料，也可以选带一定弹性的材料。在两个可扩笼形体110、120的中心距变化的情况下，柔性壁30可以具备弹性，以在适应中心距变化的条件下减小装置皱缩时的外部轮廓。在两个可扩笼形体110、120的中心距变化的情况下，柔性壁30也可以不具备弹性，例如，柔性壁30可以采用织布，在两个可扩笼形体110、120的中心距变化时，柔性壁30展开或折叠。
在一种可选的实施例中，在扩张球囊装置100扩张过程中，两个可扩笼形体110、120的中心距不变，柔性壁30采用不带弹性的材料。柔性壁30跟随可扩笼形体110、120的收缩而径向折叠且轴向无折叠，柔性壁30跟随可扩笼形体110、120的扩张而径向展开且轴向不拉伸。
在另一种可选的实施例中，在扩张球囊装置100扩张过程中，两个可扩笼形体110、120的中心距不变，柔性壁30采用带弹性的材料。当可扩笼形体110、120收缩时，柔性壁30可以径向收缩且轴向无折叠。在优选的实施方式中，柔性壁30径向收缩时可以没有径向折叠，即当可扩笼形体110、120扩张时，柔性壁30沿径向弹性变形。
在又一种可选的实施例中，在扩张球囊装置100扩张过程中，两个可扩笼形体110、120的中心距变长，柔性壁30采用带弹性的材料。当可扩笼形体110、120收缩时，柔性壁30可以径向收缩且轴向无折叠。在优选的实施方式中，柔性壁30径向收缩时可以无径向折叠。例如，柔性壁30沿轴向和径向均弹性变形。此时，扩张球囊装置100在皱缩情况下的外部轮廓进一步减小。
在又一种可选的实施例中，在扩张球囊装置100扩张过程中，两个可扩笼形体110、120的中心距变长，柔性壁30采用不带弹性的材料。当可扩笼形体110、120收缩时，柔性壁30在轴向和径向折叠或瘪缩；当可扩笼形体110、120扩张时，柔性壁30沿轴向和径向无弹性地展开。
根据本公开的一些实施例，如图8和图9所示，柔性壁30上设置有刚性支撑件31，能够增强柔性壁30的刚性，便于狭窄部位受力扩张。沿轴20的方向，刚性支撑件31的两端连接于柔性壁30的两端。
在本公开的一些具体实施例中，刚性支撑件31设置在柔性壁30的内表面或嵌设在柔性壁30内。当扩张球囊装置100扩张时，刚性支撑件31可能会与狭窄病变部位发生相对位移，将刚性支撑件31设置在柔性壁30的内表面或嵌设在柔性壁30内，可以防止刚性支撑件31磨伤组织。当刚性支撑件31嵌设于柔性壁30内时，可以理解为柔性壁30包括两层壁膜(图中未示出)，两层壁膜之间形成容置空间(图中未示出)，刚性支撑件31被容纳于容置空间内；两层壁膜的两端固定连接以构成封闭的容置空间，以防止刚性支撑件31脱离。
根据本公开的一些实施例，如图8所示，刚性支撑件31可以为轴向刚性支撑件311。当 刚性支撑件31为轴向刚性支撑件311时，轴向刚性支撑件311设置有多个，多个轴向刚性支撑件311沿轴20的圆周方向分布于柔性壁30，在柔性壁30随可扩笼形体110、120收缩时，多个轴向刚性支撑件311向轴20聚拢。轴向刚性支撑件311适用于扩张时两个可扩笼形体110、120的中心距不变的情况，也适用于扩张时两个可扩笼形体110、120的中心距变化的情况。轴向刚性支撑件311既可以为可拉伸的轴状部件，也可以为不可拉伸的轴状部件。
在一种可选的实施例中，扩张球囊装置100在扩张过程中，两个可扩笼形体110、120的中心距变长，轴向刚性支撑件311采用可拉伸的轴状部件。轴向刚性支撑件311的两端与柔性壁30固定连接，当扩张球囊装置100在扩张或收缩过程中，柔性壁30能够带动轴向刚性支撑件311实现轴向的拉伸或收缩。刚性支撑件31为可拉伸结构，可以随两个可扩笼形体110、120的扩张而延伸，随两个可扩笼形体110、120的收缩而收缩，扩张时为狭窄部位提供进一步的扩张支撑力，收缩时节省空间减小装置体积。
在又一种可选的实施例中，扩张球囊装置100在扩张过程中，两个可扩笼形体110、120的中心距变长，轴向刚性支撑件311采用不可拉伸的轴状部件。
例如，柔性壁30包括沿轴向依次分布的三段结构，位于两端的第一段和第三段为具有弹性的结构，第一段和第三段分别与可扩笼形体110和可扩笼形体120连接，位于中间的第二段为不具有弹性的结构，轴向刚性支撑件311采用不可拉伸的轴状部件，轴向刚性支撑件311连接于第二段，轴向刚性支撑件311的端部延伸至第一段和第三段。
再例如，柔性壁30整体为弹性材质，轴向刚性支撑件311采用不可拉伸的轴状部件，轴向刚性支撑件311通过柔性壁30上的至少两个连接点与柔性壁30连接，其中，连接点沿轴向间隔分布，且轴向刚性支撑件311与至少一个连接点滑动配合。在一些实施方式中，柔性壁30上设置有一个固定连接点和至少一个活动连接点，固定连接点位于柔性壁30的一端，轴向刚性支撑件311的一端与固定连接点固定连接，轴向刚性支撑件311与柔性壁30的至少一个活动连接点滑动配合；在另一种实施方式中，柔性壁30的中部设置一个固定连接点，轴向刚性支撑件311与固定连接点固定连接，柔性壁30上还设置有至少两个活动连接点，至少两个活动连接点位于固定连接点的两侧，轴向刚性支撑件311与至少两个活动连接点滑动配合。
根据本公开的另一些实施例，如图9所示，刚性支撑件31可以为螺旋刚性支撑件312。当刚性支撑件31为螺旋刚性支撑件312时，螺旋刚性支撑件312螺旋分布于柔性壁30上。螺旋刚性支撑件312适用于扩张时两个可扩笼形体110、120的中心距不变的情况，也适用于扩张时两个可扩笼形体110、120的中心距变化的情况。螺旋刚性支撑件312的两端与柔性壁30的两端固定连接，螺旋刚性支撑件312既可以为可拉伸的结构(类似弹簧形状，能够实现轴向和径向的形变)，也可以为不可拉伸的结构。
在一种可选的实施例中，扩张球囊装置100扩张时两个可扩笼形体110、120的中心距变长，螺旋刚性支撑件312采用可拉伸的螺旋形部件。螺旋刚性支撑件312的两端固定连接于柔 性壁30的两端，螺旋刚性支撑件312采用具有一定韧性的材质，螺旋刚性支撑件312随柔性壁30的扩张同时产生轴向和径向的扩张(轴向长度和直径同时变大)，螺旋刚性支撑件312跟随柔性壁30的收缩同时产生轴向和径向的收缩(轴向长度和直径同时变小)。
在另一种可选的实施例中，扩张球囊装置100扩张时两个可扩笼形体110、120的中心距不变，螺旋刚性支撑件312采用可拉伸的螺旋形部件。螺旋刚性支撑件312的两端固定连接于柔性壁30的两端，螺旋刚性支撑件312采用具有一定韧性的材质，螺旋刚性支撑件312跟随柔性壁30的扩张产生径向的扩张(直径变大且轴向长度不变)，螺旋刚性支撑件312跟随柔性壁30的收缩产生径向的收缩(直径变小且轴向长度不变)。
作为本公开的一些可选实施例，当刚性支撑件31采用不可拉伸的部件(例如轴向刚性支撑件311和/或螺旋刚性支撑件312)时，刚性支撑件31可以设置于柔性壁30的表面，直接与组织接触；刚性支撑件31也可以采用套管(图中未示出，套管可以为弹性，也可以为非弹性)，套管套设于刚性支撑件31的外部。当刚性支撑件31采用套管时，可以防止刚性支撑件31与组织直接接触，在扩张球囊装置100扩张或收缩时，刚性支撑件31不会引起组织创伤。在本公开中优选的实施方式是套管设置为弹性，弹性套管跟随柔性壁30的扩张或收缩而产生弹性变形。
根据本公开的一些实施例，该扩张球囊装置100还包括膜40，膜40既可以设置于可扩笼形体110上，也可以设置于可扩笼形体120上，还可以同时设置于两个可扩笼形体110、120上。
当两个可扩笼形体110、120不交叉设置时，膜40可以设置于可扩笼形体110的近端或远端，也可以设置于可扩笼形体120的近端或远端。
在一些实施例中，当两个可扩笼形体110、120交叉设置时，为了便于膜40的安装，膜40设置于可扩笼形体110的近端或可扩笼形体120的远端。
如图10和图11所示，作为一种可选的实施方式，膜40设置于可扩笼形体120位于远端的半球(半球是指可扩笼形体120扩张的状态)内，膜40可展开形成可扩笼形体120扩张到最大时的半球薄壁。这里，膜40与可扩笼形体120可间隔、连续或部分连续地进行固定。在一些实施例中，膜40与可扩笼形体120间隔固定，即膜40与主体部123在周向具有多个固定点，多个固定点间隔分布。进一步地，主体部123采用多个支条结构，多个支条围绕轴20分布，每个支条的两端分别与近端部121和远端部122连接，膜40与多个支条间隔固定连接(间隔一个或多个支条)。膜40允许血液从可扩笼形体120的远端部122流向近端部121，并且阻止血液从可扩笼形体120的近端部121流向远端部122。
作为另一种可选的实施方式，膜40的结构和安装位置可以采用公开号为CN101959478B的专利中的罩的方案，即膜40设置于可扩笼形体110的近端外部，膜40至少部分包围可扩笼形体110的近端，膜40包括至少一个缝并在近端部分处至少部分与主体部113的外表面分离， 多个缝可以在近端部分处按大约120度分布在膜40上。缝在膜40的近端部分限定多个小叶，当血液从远端至近端流过可扩笼形体110时，所述小叶可打开血流通道，而当血液试图从近端至远端流过可扩笼形体110时，所述小叶可关闭血流通道。
在瓣膜扩张医疗过程中，膜40受血流动力收缩或扩张，膜40的设置，限定血流单向流通，防止反流。如图11和图13所示，膜40展开从而关闭血流通道；如图10和图12所示，膜40折叠从而打开血流通道。示例地，在扩张狭窄的主动脉瓣程序中，左心室收缩时，血液从膜40与可扩笼形体120的主体部123未固定的地方流过，如图10和图12所示；左心室舒张时，膜40与可扩笼形体120的所有主体部123接触，膜40关闭血流通道，阻断血液反流，如图11和图13所示。
在一个或多个实施例中，该扩张球囊装置100还包括驱动线50。如图14和图15所示，驱动线50与可扩笼形体110的移动端和可扩笼形体120的移动端连接，驱动线50配置成控制可扩笼形体110的移动端和可扩笼形体120的移动端移动，从而便于实现可扩笼形体110、120的扩张。通过驱动线50控制可扩笼形体110的移动端和可扩笼形体120的移动端移动，便于实现对两个可扩笼形体110、120的扩张的控制，操作方便。
需要指出的是，在本公开的其他实施方式中，驱动线50可以设置两根分支，此时可扩笼形体110和120各自仅需设置一个移动端，两根分支驱动线分别对应可扩笼形体110的移动端和可扩笼形体120的移动端，每根分支驱动线对应驱动一个可扩笼形体，从而实现两个可扩笼形体110、120的同步扩张或不同步扩张。驱动线50还可以设置三根或四根分支，此时，两个可扩笼形体110、120的四个端部中的三个或四个设置为移动端，每根分支驱动线对应驱动一个移动端，通过每根分支驱动线来驱动对应的移动端移动，以实现可扩笼形体110、120的扩张或收缩。
为了保证可扩笼形体110和可扩笼形体120能够保持扩张状态，在轴20的近端或者用户的操作端设置有锁定件(图中未示出)，锁定件配置成在驱动线50带动两个可扩笼形体110、120扩张到扩张状态之后锁定驱动线50，保证两个可扩笼形体110、120被锁定在扩张状态。
根据本公开的一些实施例，如图14和图15所示，驱动线50包括主体51、第一分支52和第二分支53，第一分支52的一端与主体51连接，第一分支52的另一端与可扩笼形体110的移动端连接，第二分支53的一端与主体51连接，第二分支53的另一端与可扩笼形体120的移动端连接。主体51与第一分支52和第二分支53连接，通过控制主体51的移动，实现对两个可扩笼形体110、120的移动端的移动控制，进而实现两个可扩笼形体110、120的扩张或收缩。
如图14和图15所示，下面以两个可扩笼形体110、120轴向交叉设置的扩张球囊装置100为例，介绍驱动线50的两种连接方式。需要注意的是，为了清晰目的，图14和图15均为省略了柔性壁30的扩张球囊装置100的示意图。
图14示意性给出了，扩张球囊装置100在扩张和收缩过程中，可扩笼形体110和可扩笼形体120的中心距变长的驱动线50连接细节。可扩笼形体110的近端部111为固定端，可扩笼形体110的远端部112为移动端；可扩笼形体120的近端部121为移动端，可扩笼形体120的远端部122为固定端；可扩笼形体120的远端部122设置有第一过线孔(图中未示出)，第一过线孔供第二分支53穿设；第二分支53的远离主体51的一端穿过第一过线孔并与可扩笼形体120的近端部121连接，可扩笼形体120的远端部122为支点的作用，便于对第二分支53的支撑。驱动线50能够控制可扩笼形体110的远端部112和可扩笼形体120的近端部121朝相反的方向移动，以实现两个可扩笼形体110、120的扩张或收缩。拉动驱动线50向近端移动时，可扩笼形体110的远端部112向近端移动，可扩笼形体120的近端部121向远端移动，扩张球囊装置100扩张。松弛驱动线50，可扩笼形体110的远端部112向远端移动，可扩笼形体120的近端部121向近端移动，扩张球囊装置100收缩。可扩笼形体110的近端部111和可扩笼形体120的远端部122为固定端，使得可扩笼形体110、120在扩张时，可扩笼形体110的远端部112和可扩笼形体120的近端部121朝相反的方向移动，从而保证柔性壁30的两端同步被拉动扩张。此种形式中，两个可扩笼形体110、120组成的扩张球囊装置100在轴20上的占用长度不发生改变。
图15示意性给出了，扩张球囊装置100在扩张和收缩过程中，可扩笼形体110和可扩笼形体120的中心距不变的驱动线50连接细节。与图14相比，不同之处是，可扩笼形体120的近端部121为固定端，可扩笼形体120的远端部122为移动端，第二分支53直接与可扩笼形体120的远端部122连接。拉动驱动线50向近端移动时，可扩笼形体110的远端部112和可扩笼形体120的远端部122均向近端移动，扩张球囊装置100扩张。松弛驱动线50，可扩笼形体110的远端部112和可扩笼形体120的远端部122均向远端移动，扩张球囊装置100收缩。可扩笼形体110的近端部111和可扩笼形体120的近端部121均为固定端，可扩笼形体110、120在扩张时，可扩笼形体110的远端部112和可扩笼形体120的远端部122均朝向各自的近端部移动，两个可扩笼形体110、120组成的扩张球囊装置100在轴20上的占用长度减小。
在本公开的一些具体实施例中，为了便于保证主体51带动第一分支52和第二分支53灵活移动，第一可扩笼形体110的固定端设置有第二过线孔(图中未示出)，主体51穿设于第二过线孔内。如图14和图15所示，可扩笼形体110的近端部111为固定端，可扩笼形体110的近端部111设置有第一安装座540，第二过线孔开设于第一安装座540上，主体51穿设于第一安装座540上的第二过线孔且能够相对于可扩笼形体110的近端部111移动，从而带动第一分支52和第二分支53相对于轴20移动。为了便于驱动线50与端部的连接，可扩笼形体110的远端部112设置有第二安装座541，可扩笼形体120的近端部121设置有第三安装座542，可扩笼形体120的远端部122设置有第四安装座543。
如图14所示，第四安装座543上开设有第一过线孔，第二分支53穿过第一过线孔后与第 三安装座542连接；为了避免第一分支52和第二分支53干涉，可扩笼形体110的远端部112上的第二安装座541位于轴20的下方，可扩笼形体120的近端部121上的第三安装座542位于轴20的上方；同时，在轴20的下方，第二分支53位于第一分支52的下方，以避免第一分支52与第二分支53干涉。第一过线孔可以沿垂直于轴20的方向延伸；第一过线孔也可以为弧形孔，其绕轴20的周向延伸，第一过线孔的两个端口位于轴20的中心线的两侧。如图15所示，可扩笼形体120的近端部121不与第二分支53连接，故近端部121上可以不设置安装座。在本公开的一些具体实施例中，两个可扩笼形体110、120轴向交叉设置时，两个移动端(例如远端部112和122)为固定距离的一个可移动整体，驱动任意一个移动端，使两个移动端同步移动。
根据本公开的一些实施例，如图16所示，该扩张球囊装置100还包括多腔管60和外套管70。
多腔管60相对于可扩笼形体110和可扩笼形体120位于轴20的近端，如图17所示，多腔管60上设置有第一腔道61和第二腔道62，轴20的近端穿设于第一腔道61，驱动线50的近端穿设于第二腔道62。驱动线50能够相对于多腔管60移动，以实现对两个可扩笼形体110、120的所有移动端的移动控制。多腔管60的第一腔道61和第二腔道62分别容纳轴20和驱动线50，使得驱动线50相对于轴20移动灵活，对驱动线50起到导向支撑的作用。
外套管70可滑动地套设于多腔管60，当两个可扩笼形体110、120处于收缩状态时，外套管70能够相对于多腔管60移动以将两个可扩笼形体110、120收纳于外套管70中。当两个可扩笼形体110、120收纳于外套管70中时，便于整个扩张球囊装置100在管道(例如血管)中的移动。两个可扩笼形体110、120在伸出外套管70后，通过驱动线50能够控制两个可扩笼形体110、120扩张或收缩。
在一个或多个实施例中，如图16所示，轴20的远端设置有导向限位部21，导向限位部21的远端设置为类似箭头形，以便于轴20在管道内移动；导向限位部21的尺寸大于轴20的直径，对可扩笼形体120的远端部122进行限位，防止可扩笼形体120与轴20在远端脱离。
根据本公开实施例的扩张球囊装置100的工作原理为：
将两个可扩笼形体110、120和柔性壁30沿轴向布置于轴20上(此时可扩笼形体120上已安装有膜40)，柔性壁30位于两个可扩笼形体110、120之间的凹部位置，柔性壁30的两端分别与两个可扩笼形体110、120连接；将轴20穿设于多腔管60的第一腔道61内，将驱动线50的远端与两个可扩笼形体110、120的移动端连接，驱动线50的近端穿设于多腔管60的第二腔道62内；外套管70套设于多腔管60的外部。使用时，将轴20及两个可扩笼形体110、120送至期望位置，使得两个可扩笼形体110、120从外套管70内露出，通过驱动线50控制两个可扩笼形体110、120扩张或收缩。
根据本公开实施例的扩张球囊装置100，在两个可扩笼形体110、120扩张的过程中，两 者中间始终形成凹部，有利于狭窄部位扩张时定位；两个可扩笼形体110、120扩张力增强；柔性壁30与瓣膜贴附性增强，更有利于瓣膜扩张。
需要说明的是，在不冲突的情况下，本公开中的实施例中的特征可以相互结合。尽管上面论述的具体实施方式描述了配置成预扩狭窄主动脉瓣的器械，但是应当理解为，本文公开的扩张球囊装置100可以用于其它狭窄病变部位的扩张，也可以用于假体瓣膜置入部署时的扩张。例如，本文公开的扩张球囊装置100可以配置成代替许多种医学程序中的可扩展球囊元件。因此，本文描述的扩张球囊装置100可以用于例如血管成形术(例如，打开梗塞的冠状动脉)、瓣膜成形术(例如，扩张狭窄的心脏瓣膜)以及常规采用扩展球囊元件的其它程序。
以上所述仅为本公开的优选实施例而已，并不用于限制本公开，对于本领域的技术人员来说，本公开可以有各种更改和变化。凡在本公开的精神和原则之内，所作的任何修改、等同替换和/或改进等，均应包含在本公开的保护范围之内。

Claims (17)

  1. 一种扩张球囊装置，其特征在于，包括：
    轴；
    两个可扩笼形体，所述两个可扩笼形体沿轴向设置于所述轴上，每个可扩笼形体均具有收缩状态和扩张状态；以及
    柔性壁，所述柔性壁与所述两个可扩笼形体连接，所述柔性壁至少部分包围所述两个可扩笼形体之间的凹部，所述柔性壁可随所述可扩笼形体的扩张而扩张。
  2. 根据权利要求1所述的扩张球囊装置，其特征在于，所述两个可扩笼形体包括位于近端的第一可扩笼形体和位于远端的第二可扩笼形体，每个可扩笼形体包括近端部、远端部和镂空的主体部，所述近端部和所述远端部设置在所述轴上且可相对彼此移动，所述主体部连接所述近端部和所述远端部且限定外部安装表面，所述柔性壁连接于所述外部安装表面；
    当所述可扩笼形体处于所述收缩状态时，所述近端部和所述远端部相距第一距离，当所述可扩笼形体处于所述扩张状态时，所述近端部和所述远端部相距第二距离，所述第二距离小于所述第一距离。
  3. 根据权利要求2所述的扩张球囊装置，其特征在于，所述主体部包括多个支条，每个支条的两端分别连接所述近端部和所述远端部，所述多个支条围绕所述轴分布。
  4. 根据权利要求2所述的扩张球囊装置，其特征在于，所述第一可扩笼形体和所述第二可扩笼形体沿轴向交叉设置；
    或，所述第一可扩笼形体和所述第二可扩笼形体沿轴向不交叉设置。
  5. 根据权利要求2所述的扩张球囊装置，其特征在于，所述柔性壁呈环绕所述轴设置的筒状结构，所述柔性壁的一端连接于所述第一可扩笼形体的外部安装表面，所述柔性壁的另一端连接于所述第二可扩笼形体的外部安装表面；
    或，所述柔性壁包括多个柔性带，所述多个柔性带围绕所述轴间隔分布，每个柔性带与所述轴平行设置，每个柔性带的一端连接于所述第一可扩笼形体的外部安装表面，每个柔性带的另一端连接于所述第二可扩笼形体的外部安装表面。
  6. 根据权利要求5所述的扩张球囊装置，其特征在于，所述柔性壁上设置有刚性支撑件。
  7. 根据权利要求6所述的扩张球囊装置，其特征在于，所述刚性支撑件设置在所述柔性壁的内表面或嵌设在所述柔性壁内。
  8. 根据权利要求6所述的扩张球囊装置，其特征在于，所述刚性支撑件为可拉伸结构。
  9. 根据权利要求8所述的扩张球囊装置，其特征在于，所述刚性支撑件为可拉伸的轴状部件，沿所述柔性壁的圆周方向布置有多个所述刚性支撑件，所述刚性支撑件平行于所述轴设置，所述刚性支撑件的两端与所述柔性壁固定连接；
    或，所述刚性支撑件为可拉伸的螺旋形部件，所述刚性支撑件螺旋分布于所述柔性壁上，所述刚性支撑件的两端与所述柔性壁固定连接。
  10. 根据权利要求2所述的扩张球囊装置，其特征在于，所述扩张球囊装置还包括：
    膜，所述膜设置于所述第二可扩笼形体和/或所述第一可扩笼形体，所述膜配置成阻止受扩张部位的血液反流。
  11. 根据权利要求10所述的扩张球囊装置，其特征在于，所述膜设置于所述第二可扩笼形体的位于远端的半球内，且与所述第二可扩笼形体的主体部间隔固定连接，所述膜允许血液从所述第二可扩笼形体的远端部流向近端部，并且阻止血液从所述第二可扩笼形体的近端部流向远端部。
  12. 根据权利要求2所述的扩张球囊装置，其特征在于
    所述第一可扩笼形体的远端被构造成第一可扩笼形体的移动端；
    所述第二可扩笼形体的近端或者远端被构造成第二可扩笼形体的移动端；
    所述扩张球囊装置还包括驱动线，所述驱动线被配置成驱动所述第一可扩笼形体的移动端和所述第二可扩笼形体的移动端移动。
  13. 根据权利要求12所述的扩张球囊装置，其特征在于，所述驱动线包括主体、第一分支和第二分支，所述第一分支的一端与所述主体连接，所述第一分支的另一端与所述第一可扩笼形体的移动端连接，所述第二分支的一端与所述主体连接，所述第二分支的另一端与所述第二可扩笼形体的移动端连接。
  14. 根据权利要求13所述的扩张球囊装置，其特征在于，所述第一可扩笼形体的近端部为固定端，所述第一可扩笼形体的远端部为移动端，所述第二可扩笼形体的近端部为移动端，所述第二可扩笼形体的远端部为固定端，所述第二可扩笼形体的固定端设置有第一过线孔，所述第二分支穿过所述第一过线孔并与所述第二可扩笼形体的移动端连接，所述驱动线能够控制所述第一可扩笼形体的移动端和所述第二可扩笼形体的移动端朝相反的方向移动；
    或，所述第一可扩笼形体的近端部为固定端，所述第一可扩笼形体的远端部为移动端，所述第二可扩笼形体的近端部为固定端，所述第二可扩笼形体的远端部为移动端，所述驱动线能够控制所述第一可扩笼形体的移动端和所述第二可扩笼形体的移动端朝相同的方向移动。
  15. 根据权利要求14所述的扩张球囊装置，其特征在于，所述第一可扩笼形体的固定端设置有第二过线孔，所述主体穿过所述第二过线孔。
  16. 根据权利要求1-15任一项所述的扩张球囊装置，其特征在于，所述柔性壁由弹性材料制成。
  17. 一种扩张球囊装置的制作方法，其特征在于，所述制作方法包括：
    将第一可扩笼形体的近端部、第二可扩笼形体的近端部、第一可扩笼形体的远端部及第二可扩笼形体的远端部由近端到远端间隔设置于轴上；
    将第一可扩笼形体的主体部一端与第一可扩笼形体的远端部连接，将第二可扩笼形体的主体部的一端与第二可扩笼形体的近端部连接，然后将第二可扩笼形体的主体部与第一可扩笼形体的主体部交叉；
    将第二可扩笼形体的主体部的另一端与第二可扩笼形体的远端部连接，将第一可扩笼形体的主体部的另一端与第一可扩笼形体的近端部连接，完成两个可扩笼形体的轴向交叉装配；以及
    将柔性壁的两端分别连接于第一可扩笼形体的主体部和第二可扩笼形体的主体部。
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