WO2024037149A1 - 刀片隐藏式切割球囊导管 - Google Patents

刀片隐藏式切割球囊导管 Download PDF

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Publication number
WO2024037149A1
WO2024037149A1 PCT/CN2023/099422 CN2023099422W WO2024037149A1 WO 2024037149 A1 WO2024037149 A1 WO 2024037149A1 CN 2023099422 W CN2023099422 W CN 2023099422W WO 2024037149 A1 WO2024037149 A1 WO 2024037149A1
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WO
WIPO (PCT)
Prior art keywords
balloon
cutting
push
tube
blade
Prior art date
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PCT/CN2023/099422
Other languages
English (en)
French (fr)
Inventor
刘朝生
张志军
李斌
Original Assignee
广东博迈医疗科技股份有限公司
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Filing date
Publication date
Application filed by 广东博迈医疗科技股份有限公司 filed Critical 广东博迈医疗科技股份有限公司
Priority to EP23786165.3A priority Critical patent/EP4353165A1/en
Publication of WO2024037149A1 publication Critical patent/WO2024037149A1/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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/32075—Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
    • 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
    • A61M25/1006—Balloons formed between concentric tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3209—Incision instruments
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22061—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation for spreading elements apart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320056—Tunnelers
    • 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
    • A61M2025/1081—Balloon catheters with special features or adapted for special applications having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
    • 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
    • A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
    • 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
    • A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
    • 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
    • A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics
    • 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

Definitions

  • the present application relates to the technical field of interventional treatment medical devices, and in particular to a blade-concealed cutting balloon catheter.
  • vascular interventional therapy is an important treatment method for revascularization of vascular stenosis.
  • balloon catheters are usually used as the main vascular interventional treatment device.
  • ordinary balloon catheters cannot effectively expand the stenotic lesions.
  • balloon catheters with special functions such as cutting and scoring began to be developed and used.
  • the cutting balloon installs several rows of blades axially on the outer circumferential surface of the balloon. When the balloon is expanded, the blades come into contact with the lesion, thereby incising the lesion and reducing the elastic recoil of the lesion after expansion.
  • the blade Before the cutting balloon is expanded, the blade is located in the groove in the folding area of the balloon. When the balloon is expanded to reach the lesion, the blade extends out of the balloon to cut the vascular lesions regularly. This method causes irregular tearing of the blood vessels. Small clefts can reduce restenosis.
  • the diameter of the folded balloon is larger.
  • the blade material is made of stainless steel and fixed on the balloon, and the overall hardness is relatively large.
  • the cutting balloon When attached to the balloon, the cutting balloon can still only withstand minor bending. Therefore, due to the sharp and unbendable characteristics of the blade, it cannot pass through tortuous blood vessel parts during the transportation process, and there is a risk of damaging the normal blood vessel wall when bending. Especially when the lesion area expands with a large angle, it is easy to cause blood vessel perforation. and other adverse events, so the existing cutting balloon is not suitable for treating tortuous lesions and lesions with an angle greater than 45 degrees.
  • the technical problem to be solved by this application is to provide a membrane-protected cutting balloon catheter that has good processing capabilities for tortuous blood vessels, stenotic lesions, and angular lesions, and at the same time has safe cutting capabilities and reduces the risk of invasiveness during surgery. Risk of damage to normal blood vessels.
  • This patent application provides a cutting balloon, which aims to improve the passability and safety of the cutting balloon, so that it can reach the lesion through complex tortuous blood vessels, achieve effective cutting while reducing damage to the blood vessels.
  • the purpose of this application is to provide a blade-hidden cutting balloon catheter that can reach the lesion through complex tortuous blood vessels, and achieve effective cutting while reducing damage to the blood vessels.
  • a blade hidden cutting balloon catheter which includes:
  • a refillable and pressure-relieving balloon the proximal end of the balloon is connected to the distal end of the outer tube, the distal end of the balloon is connected to the inner tube, and the outer tube and the inner tube are The gap between them forms a charging and discharging pressure channel connected with the balloon;
  • the cutting assembly includes a plurality of first support rings sleeved on the outer tube and a blade set provided on each first support ring.
  • the plurality of first support rings are along the axial direction of the inner tube. Arranged, the first support ring can undergo radial elastic deformation and can slide freely, and the two adjacent blade groups are connected through a first flexible member;
  • Push-pull tube the push-pull tube is sleeved on the outer tube, and the distal end of the push-pull tube is connected to the blade set close to the push-pull tube through a second flexible member;
  • the tip head has a hollow structure and is sleeved on the distal end of the inner tube.
  • the tip head has a tapered structure.
  • the proximal end of the tip head is provided with a blocking portion. The blocking portion is used to block cutting. forward movement of components;
  • a protective bag the distal end of the protective bag is connected to the proximal end of the tip, the proximal end of the protective bag is connected to the push-pull tube, the protective bag is used to package the balloon and the cutting assembly; and, When the cutting assembly is pushed to the balloon through the push-pull tube, after the balloon is inflated, the blade set can A section of the protective bag opposite to the balloon is scratched to expose the blade set.
  • the blade set includes a plurality of blades spaced apart along the outer circumferential surface of the first support ring.
  • the height of the blade is 0.5-5mm, and the length of the blade is 1-50mm.
  • the operating end also includes an operating end provided at the proximal end of the inner tube, the outer tube and the push-pull tube.
  • the operating end is provided with a control structure connected to the push-pull tube, and the control structure is In order to drive the push-pull tube to slide forward and backward along the outer tube, the operating end is also provided with a Luer connector connected to the pressure charging and unloading channel and a port connected to the lumen of the inner tube (center of Figure 4 channel, supplementary numbering in figure).
  • the control structure includes a push-pull groove, an operating handle and a connecting frame.
  • the push-pull groove is provided on the outer wall of the operating end and communicates with the cavity of the operating end.
  • the operating handle is provided on the push-pull groove. It can slide forward and backward along the push-pull groove, the connecting frame is connected with the push-pull tube, and the operating handle is connected with the connecting frame.
  • the cutting assembly further includes a second support ring located at the distal end of all the first support rings.
  • the second support ring is a rigid ring and can slide freely.
  • the second support ring passes through the first support ring.
  • a flexible member is connected to the blade set close to the second support ring, and the inner diameter of the second support ring is greater than the inner diameter of the proximal end of the tip head and smaller than the outer diameter of the proximal end of the tip head, so that the The wall thickness of the tip serves as the stop.
  • the protective bag is provided with a transversely extending first cutting line, and the length of the first cutting line is equivalent to the length of the balloon.
  • the protective bag is also provided with a plurality of second cutting lines extending longitudinally and intersecting the first cutting lines.
  • each of the second cutting lines The two cutting lines are opposite to one of the blade groups.
  • positioning members are provided on the distal end of the push-pull tube and the inner tube in the balloon.
  • the balloon catheter of the present application has the following technical effects:
  • the cutting component is loaded at the proximal end of the balloon, loaded separately from the balloon, and the balloon and the cutting component are packaged through a protective bag. Therefore, during the process of pushing the cutting component through the push-pull tube, the cutting component is hidden in the protective bag within, greatly reducing the risk of damage to normal blood vessels caused by the cutting component during the pushing process;
  • the cutting component since multiple blade groups are connected through flexible parts and can be loaded On the support carrier that elastically deforms in the radial direction, the cutting component has good overall bending performance, which improves the ability of the cutting component to pass through tortuous blood vessels. In addition, when treating curved lesions, it can effectively avoid over-cutting of blood vessels on the outside of the bend and avoid perforation. , restenosis and other complications, and can be applied to larger lesion angles.
  • Figure 1 is a schematic plan view of the cutting balloon catheter in an embodiment of the present application, in which the cutting component and the balloon are in front-to-back positions.
  • FIG. 2 is a longitudinal cross-sectional view of part A-A in FIG. 1 .
  • Figure 3 is a schematic plan view of the cutting assembly in the embodiment of the present application.
  • Figure 4 is a schematic cross-sectional view of the operating end in the embodiment of the present application.
  • Figure 5 is a schematic three-dimensional structural diagram of the blade in the embodiment of the present application.
  • Figure 6 is a schematic structural diagram of the protective bag in the embodiment of the present application.
  • Figure 7 is a schematic plan view of the cutting balloon catheter in an embodiment of the present application, in which the cutting component is pushed to the outer layer of the balloon.
  • Figure 8 is a schematic plan view of the cutting balloon catheter in a working state according to the embodiment of the present application.
  • Figure 9 is a schematic diagram of the working state of the blade set cutting the vascular lesions in the embodiment of the present application.
  • Figure 10 is a schematic diagram of the working state of a traditional blade set for cutting vascular lesions in the prior art.
  • proximal end in the following embodiments usually refers to the end of the corresponding member that is close to the operator, and the “distal end” refers to the end of the corresponding member that is far away from the operator.
  • This embodiment discloses a blade-hidden cutting balloon catheter, which is used in vascular intervention to treat diseases such as arteriovenous fistula stenosis, peripheral blood vessel stenosis, and coronary blood vessel stenosis, and improve blood perfusion in patients.
  • the cutting balloon catheter in this embodiment includes an inner tube g1, an outer tube g2, a balloon 1, and a cutting balloon catheter.
  • the outer tube g2 is sleeved on the inner tube g1, and the distal end of the inner tube g1 passes through the outer tube g2.
  • the cavity formed by the inner tube g1 forms the guide wire channel L1 (as shown in Figure 4), that is, the inner tube g1 is used to pass the guide wire.
  • the balloon 1 has a rechargeable and pressure-relieving structure, that is, the balloon 1 can be filled with a medium to expand it to expand blood vessels, and then the medium can be withdrawn to restore the balloon 1 to a contracted state.
  • the main body of the balloon 1 is made of semi-compliant or non-compliant material.
  • the proximal end of the balloon 1 is connected to the distal end of the outer tube g2, the distal end of the balloon 1 is connected to the inner tube g1, and the gap between the outer tube g2 and the inner tube g1 forms a charging and discharging channel L2 connected with the balloon 1. ( Figure 4), the balloon 1 is filled or depressurized through the pressure filling and pressure relief channel.
  • the cutting component is used to cooperate with the balloon 1 to cut the diseased part.
  • the cutting component is separated from the balloon 1 Assembling, only when the balloon 1 is pushed to the target area, the cutting component is moved to near the outer circumferential surface of the balloon 1, and then the balloon 1 is expanded to exert radial pressure on the cutting component. Under the action of this radial pressure, The cutting component performs cutting of diseased tissue.
  • the cutting assembly in this embodiment includes a plurality of first support rings 30 arranged at intervals and a blade set 31 provided on each first support ring 30.
  • the first support ring 30 is sleeved on the outer tube g2.
  • a plurality of first support rings 30 are arranged along the axial direction of the inner tube g1.
  • the number of first support rings 30 is set according to the length of the balloon 1 so that the length of the plurality of first support rings 30 from the head end to the end can cover the entire balloon 1 .
  • the first support ring 30 can undergo radial elastic deformation and can slide freely, so that the first support ring 30 can be pushed from the outer tube g2 to the balloon 1 (as shown in Figure 7), or can be retreated from the balloon 1 to the outer tube. g2.
  • two adjacent blade groups 31 are connected through the first flexible member 32, so that each blade group 31 is adjacent to each other and becomes a whole, and the flexible structure based on the first flexible member 32 can be freely bent. Due to the connection of the flexible structure, several blade groups 31 can adapt to different angles following the curvature of blood vessels, thereby making it easier to pass through tortuous blood vessels.
  • the material of the first flexible part 32 in this embodiment is preferably any one of silicone, TPU, Pebax, and nylon, and the length of the first flexible part 32 is 1 to 10 mm.
  • the push-pull tube 5 it is sleeved on the outer tube g2 and can slide along the outer tube g2.
  • the distal end of the push-pull tube 5 is connected to the blade set 31 close to the push-pull tube 5 through the second flexible member 6, so that the push-pull tube 5 5.
  • Each blade set 31 together with the first support ring 30 can be pushed to the outer peripheral surface of the balloon 1, so that this embodiment
  • the provided blade set 31 can effectively cut the lesion, and each blade set 31 together with the first support ring 30 can be pulled back from the balloon 1 .
  • the material of the push-pull tube 5 in this embodiment can be any one of nylon, Pebax, multi-layer braided tube, and metal spiral cut tube.
  • the tip head 2 in this embodiment has a hollow structure and is sleeved on the distal end of the inner tube g1.
  • the tip head 2 has a tapered structure to reduce the propulsion resistance of the cutting balloon catheter in the blood vessel.
  • the proximal end of the tip head 2 is provided with
  • the blocking part 20 is used to block the forward movement of the cutting assembly and prevent the cutting assembly from detaching from the inner tube g1.
  • the proximal end of the protective bag 4 is connected to the push-pull tube 5.
  • the protective bag 4 is used to encapsulate the balloon 1 and the cutting assembly. That is, the protective bag 4 is used to wrap the balloon 1 and the cutting assembly, thereby effectively reducing the impact of the cutting assembly on normal conditions. Risk of damage to blood vessels.
  • the blade set 31 can cut the section of the protective bag 4 opposite to the balloon 1 (that is, the front half of the protective bag 4). (Fig. 8), so that the blade set 31 is exposed.
  • the blade set 31 includes a plurality of blades 310 spaced apart along the outer circumferential surface of the first support ring 30 .
  • each blade group 31 is equipped with four blades 310 , and the four blades 310 are evenly distributed on the outer peripheral surface of the first support ring 30 , so that diseased tissue in all directions around the outer periphery of the balloon 1 can be cut.
  • the height of the blade 310 is 0.5-5 mm, and the length of the blade 310 is 1-50 mm.
  • each blade group 31 in this embodiment is configured with other numbers of blades 310, for example, the number of blades 310 is 2, 3, 5, 6, 7, 8, 9, 10 pieces, not limited to the above number.
  • the number of blades 310 in this embodiment is determined according to the length of the balloon 1 .
  • the material of the blade 310 in this embodiment is an alloy.
  • the material of the blade 310 can also be pure metal, plastic, ceramic or other materials with higher hardness.
  • the protective bag 4 in this embodiment is provided with a transversely extending The length of the first cutting line 40 is equivalent to the length of the balloon 1 .
  • the protective bag 4 is also provided with a number of second cutting lines 41 extending longitudinally and intersecting the first cutting lines 40.
  • each second cutting line 41 is connected to one of the second cutting lines 41.
  • the blade set 31 faces each other.
  • dotting such as laser dotting
  • the cutting balloon catheter in this embodiment also includes an operating end 7 provided at the proximal ends of the inner tube g1, the outer tube g2, and the push-pull tube 5.
  • the operating end 7 is provided with a control structure connected to the push-pull tube 5.
  • the control structure is used to drive the push-pull tube 5 to slide forward and backward along the outer tube g2.
  • the operating end 7 is also provided with a Luer connector 73 connected to the charging and unloading pressure channel. That is, the outer tube g2 passes through the operating end 7 and is connected to the Luer connector 73 .
  • the outer tube g2 is controlled to slide forward and backward through the control structure on the operating end 7, thereby driving the cutting assembly to move forward and backward.
  • the proximal end of the operating end 7 is also provided with a port 74 that communicates with the lumen of the inner tube g1, that is, the guide wire channel L1, to facilitate the passage of the guide wire.
  • the control structure includes a push-pull groove 70 , an operating handle 71 and a connecting frame 72 .
  • the push-pull groove 70 is disposed on the outer wall of the operating end 7 and communicates with the cavity of the operating end 7.
  • the push-pull groove 70 extends transversely along the front and rear sliding direction of the outer tube g2.
  • the operating handle 71 is disposed in the push-pull groove 70 and can move along the push-pull groove 70. 70 slides forward and backward, the connecting frame 72 is connected with the push-pull tube 5, and the operating handle 71 is connected with the connecting frame 72. When it is necessary to push or retract the cutting assembly, it is only necessary to push the operating handle 71 to slide along the push-pull groove 70 .
  • the distal end of the push-pull tube 5 and the inner tube g1 in the balloon 1 are provided with positioning parts.
  • the positioning part at the distal end of the push-pull tube 5 is the developing part X1, which is located in the balloon 1.
  • the positioning parts at the proximal and distal ends of the inner tube g1 are developing parts X2 and X3. Through this development X1, the specific position of the moving end of the push-pull tube 5 can be effectively confirmed, thereby sending the cutting assembly to the target position.
  • the developing parts X2 and X3 the position of the balloon 1 can be accurately positioned.
  • the cutting assembly also includes a second support ring 33 located at the distal end of all first support rings 30.
  • the second support ring 33 is a rigid ring and can slide freely.
  • the second support ring 33 passes through the first support ring 30.
  • a flexible member 32 is connected to the blade set 31 close to the second support ring 33.
  • the inner diameter of the second support ring 33 is greater than the inner diameter of the proximal end of the tip head 2 and smaller than the outer diameter of the proximal end of the tip head 2, so that the tip head 2 is close to the blade set 31.
  • the end wall of the end is used as the blocking part 20, the structure is simple, and the effect is reliable.
  • the second support ring 33 is a rigid structure, and its diameter will not change according to external conditions. Therefore, when the blade set 31 is subjected to radial pressure and performs a cutting action, the second support ring 33 is always against the tip. on the end wall of the proximal end of head 2, thereby avoiding The blade set 31 moves out of the tip head 2 .
  • the proximal end of the tip head 2 is also provided with a step 21, and the distal end of the protective bag 4 is attached to the step 21.
  • the cutting balloon catheter can be cut. Avoid the protective bag 4 from being damaged by impact.
  • the surfaces of the tip head 2 and the outer tube g2 are provided with a hydrophilic coating (not shown), thereby effectively reducing the frictional resistance of the tip head 2 and the outer tube g2.
  • the expansion medium is filled into the charging and discharging channel L2 through the Luer connector 73 on the operating end 7, as shown in Figure 8, thereby inflating the balloon 1.
  • the first support ring 30 is elastically deformed. , the diameter becomes larger, thereby exerting radial pressure on the blade set 31 on the first support ring 30, and the blade set 31 cuts the protective bag 4 along the first cutting line 40 and the second cutting line 41, thereby exposing the blade set 31, Under the action of this radial pressure, each blade 310 performs a cutting action on the diseased tissue; then, the medium in the charging and discharging pressure channel L2 is extracted and charged again, and this is repeated several times to complete the cutting treatment;
  • the operating handle 71 drives the push-pull tube 5 to move in the proximal direction, so that the push-pull tube 5 drives the cutting assembly from the balloon 1 to the proximal direction through the second flexible member 6
  • the outer tube moves in the direction g2, and finally moves to the space where the second half of the protective bag 4 is, and then moves along the guide Wire the entire cutting balloon catheter out of the blood vessel.
  • the cutting component is loaded at the proximal end of the balloon 1 and is loaded separately from the balloon 1, and the balloon 1 and the cutting component are packaged through the protective bag 4, and the treatment is completed and returned.
  • the blade set 31 is wrapped by the second half of the protective bag 4. Therefore, during the process of pushing and pulling the cutting assembly through the push-pull tube 5, the cutting assembly is hidden in the protective bag 4, which greatly reduces the normal impact of the cutting assembly during the pushing process. Risk of damage to blood vessels.
  • the multiple blade groups 31 are connected through flexible parts and loaded on a support carrier that can elastically deform in the radial direction, the overall bending performance of the cutting assembly is good, which improves the ability of the cutting assembly to pass through tortuous blood vessels. .
  • the traditional blade set 31' cannot adaptively change the curvature following the curved surface of the lesion. Therefore, it can only remove part of the lesion.
  • each blade group 31 can It is attached to each curved position of the lesion to achieve precise resection of the lesion and achieve good therapeutic effects. It can also effectively avoid excessive cutting of the lesion and avoid complications such as perforation and restenosis. It is also applicable at larger lesion angles.

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Abstract

一种刀片隐藏式切割球囊导管，其包括内管（g1）、外管（g2）、切割组件、推拉管（5）以及保护袋（4）；外管（g2）与内管（g1）之间的空隙形成与球囊（1）连通的充卸压通道（L2）；切割组件包括若干第一支撑环（30）和设置于每一第一支撑环（30）上的刀片组（31），第一支撑环（30）可发生径向弹性形变且可自由滑动；推拉管（5）套设于外管（g2）上，推拉管（5）的远端通过第二柔性件（6）与靠近的刀片组（31）连接；保护袋（4）的近端与推拉管（5）连接，保护袋（4）用于封装球囊（1）和切割组件；且，当通过推拉管（5）将切割组件推送至球囊（1）处时，刀片组（31）可将保护袋（4）的与球囊（1）相对的一段划破，以使得刀片组（31）露出；切割球囊导管具有良好的迂曲血管、狭窄病变和成角病变的处理能力，同时具有安全的切割能力，降低手术过程中对正常血管的损伤风险。

Description

刀片隐藏式切割球囊导管 技术领域
本申请涉及介入式治疗医疗器械技术领域，尤其涉及一种刀片隐藏式切割球囊导管。
背景技术
血管介入治疗，是进行血管狭窄病变血运重建治疗的一种重要的治疗方式。在血管介入治疗中，通常使用球囊导管作为主要的血管介入治疗器械。对于一些血管内的狭窄病变，如钙化、斑块或纤维化等狭窄病变，普通的球囊导管无法对狭窄病变部位进行有效扩张。为解决该问题，带有切割、刻痕等特殊功能的球囊导管开始被研发和使用。
切割球囊通过在球囊的外圆周表面上轴向安装若干排刀片，球囊扩张时刀片与病变部位接触，从而切开病变，减小病变扩张后的弹性回缩。
切割球囊在扩张之前，刀片位于球囊折叠区的凹槽内，到达病变位置而扩张球囊时，刀片伸出球囊外面，对血管病变进行规则切割，这种方式造成的血管不规则撕裂小，能降低再狭窄。但对于目前的切割球囊，由于刀片和刀片底座的存在，以及其特殊的折叠方式，折叠后球囊的直径较大，在处理狭窄病变时，其通过能力较差，一般需经过其他器械进行预处理；另外，刀片材料为不锈钢材质，并固定在球囊上，整体硬度较大，虽然现有技术采用多个短刀片排列，并间隔一定长度，但刀片底座仍是一个整体，由胶水粘接在球囊上，切割球囊仍然只能承受较小的弯曲。因此，由于刀刃锋利和不易弯曲的特性，在输送过程中无法通过迂曲的血管部位，而且过弯时有损伤正常血管壁的风险，特别是在成角较大的病变部位扩张，易造成血管穿孔等不良事件，故现有切割球囊不适合处理迂曲病变和成角大于45度的病变。
鉴于此，本申请要解决的技术问题在于提供膜保护型切割球囊导管，使其具有良好的迂曲血管、狭窄病变和成角病变的处理能力，同时具有安全的切割能力，降低手术过程中对正常血管的损伤风险。
本申请专利提供一种切割球囊，旨在提高切割球囊的通过性和安全性，使其能够通过复杂迂曲血管到达病变处能实现有效切割的同时降低对血管的损伤。
申请内容
本申请的目的是提供一种刀片隐藏式切割球囊导管，使其能够通过复杂迂曲血管到达病变处，并实现有效切割的同时降低对血管的损伤。
为了实现上述目的，本申请公开了一种刀片隐藏式切割球囊导管，其包括：
内管和套设于所述内管上的外管，且所述内管的远端穿出所述外管；
可充卸压式的球囊，所述球囊的近端与所述外管的远端连接，所述球囊的远端与所述内管连接，所述外管与所述内管之间的空隙形成与所述球囊连通的充卸压通道；
切割组件，包括若干套设于所述外管上的第一支撑环和设置于每一所述第一支撑环上的刀片组，若干所述第一支撑环沿所述内管的轴向方向排列，所述第一支撑环可发生径向弹性形变且可自由滑动，彼此相邻两所述刀片组通过第一柔性件连接；
推拉管，所述推拉管套设于所述外管上，所述推拉管的远端通过第二柔性件与靠近所述推拉管的所述刀片组连接；
尖端头，所述尖端头为中空结构，套设于所述内管的远端，所述尖端头具有锥度结构，所述尖端头的近端设有阻挡部，所述阻挡部用于阻挡切割组件的前移；
保护袋，所述保护袋的远端与尖端的近端连接，所述保护袋的近端与所述推拉管连接，所述保护袋用于封装所述球囊和所述切割组件；且，当通过所述推拉管将所述切割组件推送至所述球囊处时，所述球囊膨胀后，所述刀片组可 将所述保护袋的与所述球囊相对的一段划破，以使得所述刀片组露出。
较佳地，所述刀片组包括若干沿所述第一支撑环外周面间隔设置的刀片。
较佳地，所述刀片的高度为0.5～5mm，所述刀片的长度为1～50mm。
较佳地，还包括设置于所述内管、所述外管以及所述推拉管近端的操作端，所述操作端上设置有与所述推拉管连接的控制结构，所述控制结构用于驱动所述推拉管沿所述外管前后滑动，所述操作端上还设置有与所述充卸压通道连通的鲁尔接头和连通所述内管的管腔的端口(图4的中心通道，图中补充编号)。
较佳地，所述控制结构包括推拉槽、操作手柄以及连接架，所述推拉槽设置于所述操作端的外壁面并与所述操作端的空腔连通，所述操作手柄设置于所述推拉槽内并可沿所述推拉槽前后滑动，所述连接架与所述推拉管连接，所述操作手柄与所述连接架连接。
较佳地，所述切割组件还包括位于所有所述第一支撑环远端的第二支撑环，所述第二支撑环为刚性环且可自由滑动，所述第二支撑环通过所述第一柔性件与靠近所述第二支撑环的所述刀片组连接，所述第二支撑环的内径大于所述尖端头近端的内径且小于所述尖端头近端的外径，以使得所述尖端头的壁厚用作所述阻挡部。
较佳地，所述保护袋上设置有横向延伸的第一切割线，所述第一切割线的长度与所述球囊的长度相当。
较佳地，所述保护袋上还设置有若干纵向延伸并与所述第一切割线交叉的第二切割线，当所述切割组件被推送至所述球囊处时，每一所述第二切割线与其中一组所述刀片组相对。
较佳地，所述推拉管的远端、所述球囊内的内管上均设置有定位件。
与现有技术相比，本申请球囊导管具有如下技术效果：
1、切割组件装载在球囊的近端，与球囊分开装载，并通过保护袋将球囊和切割组件封装，因此，在通过推拉管推送切割组件的过程中，切割组件被隐藏在保护袋内，大幅降低推送过程中切割组件对正常血管的损伤风险；
2、对于切割组件来说，由于多个刀片组之间通过柔性件连接，且装载在可 径向发生弹性形变的支撑载体上，切割组件整体弯曲性能好，提升切割组件通过迂曲血管的能力，另外，在处理弯曲的病变部位时，能有效避免对弯曲外侧的血管的过度切割，避免穿孔、再狭窄等并发症的发生，且能适用于更大的病变角度。
附图说明
图1为本申请实施例中切割球囊导管的平面结构示意图，其中切割组件与球囊处于前后位置。
图2为图1中A-A部的纵截面图。
图3为本申请实施例中切割组件的平面结构示意图。
图4为本申请实施例中操作端的剖面示意图。
图5为本申请实施例中刀片的立体结构示意图。
图6为本申请实施例中保护袋的结构示意图。
图7为本申请实施例中切割球囊导管的平面结构示意图，其中切割组件被推送至球囊外层位置。
图8为本申请实施例中切割球囊导管处于工作状态的平面结构示意图。
图9为本申请实施例中刀片组切割血管病变处的工作状态示意图。
图10为现有技术中传统刀片组切割血管病变处的工作状态示意图。
具体实施方式
为详细说明本申请的技术内容、构造特征、所实现目的及效果，以下结合实施方式并配合附图详予说明。
首先需要说明的是，下述实施例中的术语“近端”通常是指对应构件靠近操作者的一端，“远端”是指对应构件远离操作者的一端。
本实施例公开了一种刀片隐藏式切割球囊导管，用于血管介入中治疗动静脉瘘狭窄、外周血管狭窄和冠脉血管狭窄等疾病，改善患者血流灌注。具体地，如图1至图3，本实施例中的切割球囊导管包括内管g1、外管g2、球囊1、切 割组件、推拉管5、尖端头2以及保护袋4。
外管g2套设于内管g1上，且内管g1的远端穿出外管g2。本实施例中，由内管g1形成的空腔形成导丝通道L1(如图4)，也即内管g1用于穿设导丝。
球囊1具有可充卸压式结构，也即可充入介质使其膨胀，起到扩张血管的作用，然后将介质抽出使得球囊1恢复至收缩状态。本实施例中，球囊1的主体采用半顺应性或非顺应性材料制成。球囊1的近端与外管g2的远端连接，球囊1的远端与内管g1连接，外管g2与内管g1之间的空隙形成与球囊1连通的充卸压通道L2(如图4)，通过该充卸压通道对球囊1执行充压或卸压工作。
切割组件用于与球囊1配合以切割病变部位，为避免沿导丝推送过程中切割组件损伤到正常的血管，同时提升通过迂曲血管的能力，本实施例中，切割组件与球囊1分开装配，仅当球囊1被推送到靶区时，才将切割组件移动至球囊1外周面附近，然后球囊1膨胀，对切割组件施加径向压力，在该径向压力的作用下，切割组件实施对病变组织的切割。
基于上述构思，本实施例中的切割组件包括若干间隔设置的第一支撑环30和设置于每一第一支撑环30上的刀片组31，第一支撑环30套设于外管g2上，且，若干第一支撑环30沿内管g1的轴向方向排列。具体地，根据球囊1的长度设置第一支撑环30的数量，使得多个第一支撑环30自首端至末端的长度能够覆盖整个球囊1。第一支撑环30可发生径向弹性形变且可自由滑动，以使得可将第一支撑环30从外管g2推送至球囊1上(如图7)，或从球囊1退回到外管g2。另外，彼此相邻两刀片组31通过第一柔性件32连接，从而使得各个刀片组31彼此相邻成为一个整体，而且基于第一柔性件32的柔性结构可自由弯曲。由于柔性结构的连接，若干刀片组31之间可跟随血管的弯曲自适应变换不同的角度，从而容易通过迂曲血管。本实施例中的第一柔性件32的材料优选为硅胶、TPU、Pebax、尼龙中的任一种，第一柔性件32的长度为1～10mm。
对于推拉管5，其套设于外管g2上，并可沿外管g2滑动，推拉管5的远端通过第二柔性件6与靠近推拉管5的刀片组31连接，从而使得，推拉管5可将各个刀片组31连同第一支撑环30推送至球囊1的外周面上，进而使本实施例 所提供的刀片组31能够有效地对病变处进行切割作业，并可将各个刀片组31连同第一支撑环30从球囊1处拉回。具体地，本实施例中的推拉管5的材质可为尼龙、Pebax、多层编织管、金属螺旋切割管中的任一种。
本实施例中的尖端头2为中空结构，套设于内管g1的远端，尖端头2具有锥度结构，以减轻切割球囊导管在血管中的推进阻力，尖端头2的近端设有阻挡部20，该阻挡部20用于阻挡切割组件的前移，避免切割组件从内管g1脱离。
保护袋4的近端与推拉管5连接，保护袋4用于封装球囊1和切割组件，也即，通过保护袋4将球囊1和切割组件包起来，从而有效的降低切割组件对正常血管的损伤风险。当通过推拉管5将切割组件推送至球囊1处时，球囊1膨胀后，刀片组31可将保护袋4的与球囊1相对的一段(也即保护袋4的前半段)划破(如图8)，以使得刀片组31露出。
可选地，如图2和图5，刀片组31包括若干沿第一支撑环30外周面间隔设置的刀片310。本实施例中，每一刀片组31配置有四个刀片310，该四个刀片310均匀分布在第一支撑环30的外周面上，从而可切割球囊1外周各个方向的病变组织。具体地，刀片310的高度为0.5～5mm，刀片310的长度为1～50mm。
可以理解的是，本实施例中的每一刀片组31配置有其他数量的刀片310，例如刀片310的数量为2个、3个、5个、6个、7个、8个、9个、10个，并不局限为以上数量。
在一种优选的实施例中，本实施例中的刀片310的数量根据球囊1的长度来进行确定。
本实施例中的刀片310的材料为合金，当然在其他的实施例中的刀片310的材料也可以为纯金属、塑料、陶瓷等硬度较高的材料。
可选地，当将切割组件推送至球囊1外周面时，为使得刀片组31有效破开保护袋4的前半部分，如图6，本实施例中的保护袋4上设置有横向延伸的第一切割线40，第一切割线40的长度与球囊1的长度相当。进一步地，保护袋4上还设置有若干纵向延伸并与第一切割线40交叉的第二切割线41，当切割组件被推送至球囊1处时，每一第二切割线41与其中一组刀片组31相对。本实施例 中，对于第一切割线40和第二切割线41，通过在保护袋4上沿预定轨迹间隔打点(如激光打点)所得，当刀片组31经过第一切割线40和第二切割线41的交叉点时，可轻易将保护袋4破开，从而露出刀片组31中的刀片。
如图1和图4，为方便操作，本实施例中的切割球囊导管还包括设置于内管g1、外管g2以及推拉管5近端的操作端7。操作端7上设置有与推拉管5连接的控制结构，控制结构用于驱动推拉管5沿外管g2前后滑动，操作端7上还设置有与充卸压通道连通的鲁尔接头73，也即，外管g2穿过操作端7而与鲁尔接头73连接。本实施例中，通过操作端7上的控制结构操纵外管g2前后滑动，从而带动切割组件前后移动。操作端7的近端还设置有连通内管g1的管腔也即导丝通道L1的端口74，便于导丝通行。
具体地，控制结构包括推拉槽70、操作手柄71以及连接架72。推拉槽70设置于操作端7的外壁面并与操作端7的空腔连通，该推拉槽70沿外管g2的前后滑动方向横向延伸，操作手柄71设置于推拉槽70内并可沿推拉槽70前后滑动，连接架72与推拉管5连接，操作手柄71与连接架72连接。当需要推送或回撤切割组件时，只需推动操作手柄71沿推拉槽70滑动即可。
如图1，推拉管5的远端、球囊1内的内管g1上均设置有定位件，本实施例中，推拉管5的远端的定位件为显影件X1，位于球囊1内的内管g1的近端和远端的定位件为显影件X2、X3。通过该显影X1可有效确认推拉管5移动端的具体位置，从而将切割组件送至目标位置。通过显影件X2、X3，可精准定位球囊1的位置。
请再次参阅图1，如图3，切割组件还包括位于所有第一支撑环30远端的第二支撑环33，第二支撑环33为刚性环且可自由滑动，第二支撑环33通过第一柔性件32与该第二支撑环33靠近的刀片组31连接，第二支撑环33的内径大于尖端头2近端的内径且小于尖端头2近端的外径，以使得尖端头2近端的端壁用作阻挡部20，结构简单，且效果可靠。本实施例中，第二支撑环33为刚性结构，其直径不会根据外部条件发生改变，因此，在刀片组31受到径向压力而做切割动作时，第二支撑环33始终抵靠在尖端头2近端的端壁上，从而避免 刀片组31移出尖端头2。
可选地，尖端头2的近端还设置有台阶21，保护袋4的远端贴附在该台阶21上，通过该该台阶21的设置，当沿导丝推进切割球囊导管时，可避免保护袋4受到冲击而损坏。
进一步地，尖端头2和外管g2的表面设置有亲水涂层(图未示)，从而有效降低尖端头2和外管g2的摩擦阻力。
采用上述实施例提供的切割球囊导管进行介入式治疗的流程为：
首先，将导丝沿血管送至靶区；然后，将切割球囊导管的导丝通道L1套设到导丝上，并沿导丝推送，直至球囊1推送至靶区，在推送过程中，球囊1处于收缩状态，如图1，切割组件位于球囊1近端的外管g2上，且球囊1和切割组件均被保护袋4包裹；
接着，当通过球囊1内的显影件X2、X3确认球囊1到达靶区时，推动操作端7上的操作手柄71向远端方向移动，以带动推拉管5向远端方向引导，从而通过推拉管5推动刀片组31，刀片组31通过第一支撑环30沿外管g2向球囊1滑动；
当通过推拉管5远端的显影件X1确认移动到位时，停止推动操作手柄71，此时各个刀片组31均被推送至球囊1所在位置，如图7，而且位于最前端的第二支撑环33被尖端头2的阻挡部20阻挡；
然后，通过操作端7上的鲁尔接头73向充卸压通道L2中充入膨胀介质，如图8，从而使得球囊1膨胀，球囊1膨胀后，使得第一支撑环30发生弹性形变，直径变大，从而给第一支撑环30上的刀片组31施加径向压力，刀片组31沿第一切割线40和第二切割线41将保护袋4切开，从而露出刀片组31，在该径向压力的作用下，各个刀片310对病变组织实施切割动作；然后，将充卸压通道L2中的介质抽出并再次充入，如此反复几次，完成切割治疗；
最后，确认球囊1处于卸压状态，并反向推动操作手柄71，操作手柄71带动推拉管5向近端方向移动，从而推拉管5通过第二柔性件6带动切割组件由球囊1向外管g2方向移动，最终移动至保护袋4后半段所在空间，然后，沿导 丝将整个切割球囊导管从血管抽出。
由此可知，通过上述切割球囊导管，首先，由于切割组件装载在球囊1的近端，与球囊1分开装载，并通过保护袋4将球囊1和切割组件封装，且治疗结束回撤过程中，刀片组31被保护袋4的后半段包裹，因此，在通过推拉管5推拉切割组件的过程中，切割组件被隐藏在保护袋4内，大幅降低推送过程中切割组件对正常血管的损伤风险。其次，对于切割组件来说，由于多个刀片组31之间通过柔性件连接，且装载在可径向发生弹性形变的支撑载体上，切割组件整体弯曲性能好，提升切割组件通过迂曲血管的能力。另外，在处理弯曲的病变部位时，如图10，传统刀片组31’由于不能跟随病变处的弯曲面自适应改变弯曲度，因此，只能切除病变处的局部，即使多次切除，也不能达到满意效果，而对于本本申请上述实施例提供的切割球囊导管，如图9，由于多个刀片组31之间的角度可跟随病变处的弯曲形状自适应变换，因此，各个刀片组31可贴附在病变处的各个弯曲位置，从而实现对病变处的精准切除，达到良好的治疗效果，并能有效避免对病变处的过度切割，避免穿孔、再狭窄等并发症的发生，且能适用于更大的病变角度。
以上所披露的仅为本申请的优选实施例而已，当然不能以此来限定本申请之权利范围，因此依本申请专利范围所作的等同变化，仍属本申请所涵盖的范围。

Claims (9)

  1. 一种刀片隐藏式切割球囊导管，其特征在于，包括：
    内管和套设于所述内管上的外管，且所述内管的远端穿出所述外管；
    可充卸压式的球囊，所述球囊的近端与所述外管的远端连接，所述球囊的远端与所述内管连接，所述外管与所述内管之间的空隙形成与所述球囊连通的充卸压通道；
    切割组件，包括若干套设于所述外管上的第一支撑环和设置于每一所述第一支撑环上的刀片组，若干所述第一支撑环沿所述内管的轴向方向排列，所述第一支撑环可发生径向弹性形变且可自由滑动，彼此相邻两所述刀片组通过第一柔性件连接；
    推拉管，所述推拉管套设于所述外管上，所述推拉管的远端通过第二柔性件与靠近所述推拉管的所述刀片组连接；
    尖端头，所述尖端头为中空结构，套设于所述内管的远端，所述尖端头具有锥度结构，所述尖端头的近端设有阻挡部，所述阻挡部用于阻挡切割组件的前移；
    保护袋，所述保护袋的远端与尖端的近端连接，所述保护袋的近端与所述推拉管连接，所述保护袋用于封装所述球囊和所述切割组件；且，当通过所述推拉管将所述切割组件推送至所述球囊处时，所述球囊膨胀后，所述刀片组可将所述保护袋的与所述球囊相对的一段划破，以使得所述刀片组露出。
  2. 根据权利要求1所述的刀片隐藏式切割球囊导管，其特征在于，所述刀片组包括若干沿所述第一支撑环外周面间隔设置的刀片。
  3. 根据权利要求2所述的刀片隐藏式切割球囊导管，其特征在于，所述刀片的高度为0.5～5mm，所述刀片的长度为1～50mm。
  4. 根据权利要求1所述的刀片隐藏式切割球囊导管，其特征在于，还包括设置于所述内管、所述外管以及所述推拉管近端的操作端，所述操作端上设置有与所述推拉管连接的控制结构，所述控制结构用于驱动所述推拉管沿所述外管前后滑动，所述操作端上还设置有与所述充卸压通道连通的鲁尔接头和连通所述内管的管腔的端口。
  5. 根据权利要求4所述的刀片隐藏式切割球囊导管，其特征在于，所述控制结构包括推拉槽、操作手柄以及连接架，所述推拉槽设置于所述操作端的外壁面并与所述操作端的空腔连通，所述操作手柄设置于所述推拉槽内并可沿所述推拉槽前后滑动，所述连接架与所述推拉管连接，所述操作手柄与所述连接架连接。
  6. 根据权利要求1所述的刀片隐藏式切割球囊导管，其特征在于，所述切割组件还包括位于所有所述第一支撑环远端的第二支撑环，所述第二支撑环为刚性环且可自由滑动，所述第二支撑环通过所述第一柔性件与靠近所述第二支撑环的所述刀片组连接，所述第二支撑环的内径大于所述尖端头近端的内径且小于所述尖端头近端的外径，以使得所述尖端头的壁厚用作所述阻挡部。
  7. 根据权利要求1所述的刀片隐藏式切割球囊导管，其特征在于，所述保护袋上设置有横向延伸的第一切割线，所述第一切割线的长度与所述球囊的长度相当。
  8. 根据权利要求7所述的刀片隐藏式切割球囊导管，其特征在于，所述保护袋上还设置有若干纵向延伸并与所述第一切割线交叉的第二切割线，当所述切割组件被推送至所述球囊处时，每一所述第二切割线与其中一组所述刀片组相对。
  9. 根据权利要求1所述的刀片隐藏式切割球囊导管，其特征在于，所述推拉管的远端、所述球囊内的内管上均设置有定位件。
PCT/CN2023/099422 2022-08-18 2023-06-09 刀片隐藏式切割球囊导管 WO2024037149A1 (zh)

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