WO2023098708A1 - 一种丝刀和球囊装置 - Google Patents

一种丝刀和球囊装置 Download PDF

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Publication number
WO2023098708A1
WO2023098708A1 PCT/CN2022/135322 CN2022135322W WO2023098708A1 WO 2023098708 A1 WO2023098708 A1 WO 2023098708A1 CN 2022135322 W CN2022135322 W CN 2022135322W WO 2023098708 A1 WO2023098708 A1 WO 2023098708A1
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WO
WIPO (PCT)
Prior art keywords
balloon
wire
scoring
scored
distal end
Prior art date
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PCT/CN2022/135322
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English (en)
French (fr)
Inventor
古湖南
季方秋
王成
Original Assignee
山东吉威医疗制品有限公司
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Publication of WO2023098708A1 publication Critical patent/WO2023098708A1/zh

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    • 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
    • A61B17/22004—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 using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—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 using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • 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
    • A61B17/22—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
    • A61B2017/22094—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 for crossing total occlusions, i.e. piercing

Definitions

  • the present disclosure relates to balloons, and more particularly to a wire cutter and balloon device.
  • Coronary artery stenosis refers to the pathological changes in which lipids and other substances are deposited in the coronary artery intima, smooth muscle cell proliferation and collagen fibers increase, resulting in thickening and hardening of the coronary artery wall, stenosis or even occlusion of the vascular lumen, also known as coronary heart disease.
  • coronary heart disease develops to a certain extent, coronary artery stenosis gradually increases, restricting the blood flow into the myocardium, and the heart cannot get enough oxygen supply, and symptoms such as chest discomfort will occur.
  • PCI percutaneous coronary intervention
  • Drug-eluting stents are still the dominant angioplasty at present.
  • DCB drug-coated balloon
  • ISR in-stent restenosis
  • coronary artery stenosis small vessel disease
  • bifurcation disease etc. efficacy, safety and efficacy.
  • DCB drug-coated balloon
  • DES drug-eluting stent
  • pretreatment is particularly important.
  • the expansion of ordinary balloons leads to plaque compression, rupture, and elastic expansion of blood vessels, which is prone to intimal tearing and even acute occlusion.
  • the subsequent elastic recoil and proliferative response to injury are also important reasons for vascular restenosis.
  • the present disclosure provides a wire cutter and a balloon device, which, for example, improve the passability and flexibility of the balloon device, and prevent the balloon device from scratching the inner wall of a normal blood vessel during delivery.
  • the present disclosure proposes a wire cutter, which includes more than two scoring wires, two end pieces and more than two connecting rods.
  • Two or more scoring wires are spirally wound to form a helical structure.
  • the two end pieces are respectively arranged at two ends of the spiral structure, and the end pieces include a ring structure, and the ring structure includes a plurality of U-shaped rods connected end to end. More than 2 connecting rods, each connecting rod is connected to a scoring wire and a U-shaped rod at both ends, and more than 2 connecting rods extend along the axial direction of the helical structure and are parallel to each other.
  • connecting rods are provided between the end pieces located at both ends of the wire knife and the scoring wire.
  • the connecting rod is linear, and the connecting rod can be elastically deformed during the expansion process of the scored wire along with the inflation of the balloon. In this way, it can help to increase the radial expansion diameter of the scored wire and prevent the situation that the helical lock of one end of the balloon cannot be fully opened, and it is also beneficial to reduce the binding force of the scored wire to the balloon and reduce the risk of damage to the balloon ;At the same time, the linear connecting rod has an axial force on the middle spiral score wire, which can prevent the two ends of the spiral score wire from being displaced and dislocated during the balloon expansion process, resulting in uneven distribution of score wires and even score wire locks To prevent the balloon from opening, it can ensure that the scoring wire expands evenly with the inflation of the balloon.
  • the diameter of the ring structure is smaller than the diameter of the helical structure. In this way, the end piece can be more firmly fixed on the proximal end of the balloon and the distal end of the elastic tube, and while ensuring the cutting and expansion range of the scored wire, the overall outer diameter of the balloon device can be made smaller, improving product quality. Passability and flexibility.
  • the cross section of the U-shaped rod and/or the connecting rod is substantially rectangular, and the cross-sectional area of the connecting rod is smaller than that of the U-shaped rod. Since the cross-sectional area of the connecting rod is smaller than that of the U-shaped rod, the stiffness of the U-shaped rod is greater than that of the connecting rod. On the one hand, this ensures that the U-shaped rod can maintain the overall annular shape of the scored wire of the wire knife during the expansion of the balloon, improving the overall stability of the structure. On the other hand, it is also beneficial to the elastic deformation of the connecting rod, which is beneficial to Increase the radial expansion diameter of the scoring wire and prevent the helix from locking one end of the balloon so that it cannot be fully opened.
  • the cross-section of the scoring wire is approximately rectangular or approximately triangular.
  • the cross-section of the scored wire is approximately isosceles triangle or equilateral triangle.
  • the scoring wire with a triangular cross-section has good stability and has sharp corners, which can provide higher cutting force under the same balloon inflation pressure, making it easier to cut the plaque and complete the treatment.
  • two or more scoring wires are evenly distributed along the circumference, arranged parallel to each other and spirally wound in the same direction.
  • the present disclosure also proposes a balloon device, comprising the wire cutter described in any one of the above embodiments, a balloon and an outer tube.
  • the balloon has an expanded state and a deflated state.
  • the proximal end of the balloon is connected to the distal end of the outer tube.
  • the distal end of the wire knife is fixedly connected with the distal end of the balloon, and the scored wire is spirally wound on the outer surface of the balloon along the axial direction of the balloon, and the cross section of the scored wire is in the radial direction outward of the helical structure. has at least one sharp corner.
  • the balloon device further includes an elastic tube, the elastic tube is arranged on the outer surface of the distal end of the outer tube, and the distal end of the elastic tube is connected to the proximal end of the wire knife.
  • the side of the connecting rod and/or the scoring wire close to the outer surface of the balloon is a curved surface, and the curved surface is adapted to the shape of the outer surface of the balloon.
  • the circumferential winding length of each scoring wire is more than one circle.
  • the outer surface of the balloon when the balloon is in a contracted state, the outer surface of the balloon is helically provided with more than two grooves, the depth of the grooves is equal to or greater than the radial height of the scoring wires, and each scoring wire is embedded with In one groove; when the balloon is in an expanded state, the outer surface of the balloon is extended so that the sharp corners of the scoring wire protrude from the outer surface of the balloon.
  • the scoring wire is helically wound on the outer surface of the balloon along the axial direction of the balloon and embedded in the groove of the balloon.
  • the scored wire is wound helically to form a helical structure that can adjust its overall diameter as the helix unwinds and tightens.
  • the balloon is in a contracted state, so that the outer diameter of the scored wire is at least hidden or blocked by the flaps of the balloon on both sides of the groove, so that the scored wire with sharp corners will not directly contact the blood vessel Inner wall, so as to avoid the scoring wire scratching the blood vessel during the delivery of the balloon and causing complications.
  • the scored wire can expand its outer diameter as the balloon expands, and is exposed from the groove of the balloon, thereby directly contacting the lesion of the blood vessel, ensuring the cutting of the wire knife efficiency. Therefore, according to the technical solution of the present disclosure, the safety factor of the balloon device can be significantly improved and the risk can be reduced.
  • FIG. 1 is a schematic perspective view of a balloon device according to an embodiment of the present disclosure.
  • FIG. 2A is a cross-sectional view of the balloon device of FIG. 1 showing the balloon in a deflated state.
  • FIG. 2B is a cross-sectional view of the balloon device of FIG. 1 showing the balloon in an expanded state.
  • 3A to 3D are schematic cross-sectional views of a method of using a balloon device according to an embodiment of the present disclosure.
  • Fig. 4 is a schematic structural diagram of a wire cutter according to an embodiment of the present disclosure.
  • the “distal end” and “proximal end” defined in this disclosure are explained as follows.
  • the balloon device enters the blood vessel of the human body after being penetrated through the skin of the human body, and enters the lesion along the direction of the blood vessel of the human body. Taking the entrance through the human skin as the reference point, along the traveling direction of the balloon, the end away from the reference point is the distal end, and the end close to the reference point is the proximal end.
  • dilation balloons used for common vascular stenosis will cause plaque compression, rupture and elastic expansion of blood vessels during expansion, prone to intimal tearing and even acute occlusion, followed by elastic recoil and hyperplasia of damage Reactions and other adverse reactions of vascular restenosis.
  • the inventors of the present disclosure have found that, among some prior art solutions, a cutting balloon catheter is disclosed.
  • the cutting balloon catheter includes a catheter shaft and an inflatable balloon secured to a distal portion of the catheter shaft.
  • One or more cutting blades are secured to the inflatable balloon. Since the cutting blade is fixed on the balloon, the balloon is hard and has a large outer diameter, which results in poor passability of the balloon and limits the ability of the balloon to enter curved blood vessels or small blood vessels.
  • cutting blades are more prone to damage blood vessels during retraction, creating surgical complications, resulting in risky and potentially life-threatening situations.
  • the surface of the balloon is coated with metal mesh.
  • the metal mesh is directly coated on the surface of the balloon, the two can be relatively close to each other in a straight blood vessel. It will not fall off together, but when the blood vessel is over-bent, because the metal wire of the cutting unit is exposed on the outer surface, it is easy to scratch the inner wall of the blood vessel, and the inner wall of the normal blood vessel is easily scratched, which brings new risks.
  • the inventors of the present disclosure have found that the balloon devices in the above existing solutions all have deficiencies to varying degrees, and there are many limitations in clinical application. Therefore, the balloon device provided by the embodiments of the present disclosure solves some of the above-mentioned technical problems to a certain extent.
  • FIG. 1 is a schematic perspective view of a balloon device according to an embodiment of the present disclosure
  • FIGS. 2A and 2B are cross-sectional views of the balloon in a deflated state and an expanded state, respectively.
  • the balloon device includes a wire cutter 130 , a balloon 120 , an outer tube 110 and an elastic tube 140 .
  • Balloon 120 has an expanded state and a deflated state.
  • the proximal end of the balloon 120 is connected to the distal end of the outer tube 110 , and the distal end of the balloon 120 is fixedly connected to the distal end of the wire cutter 130 .
  • the elastic tube 140 is disposed on the outer surface of the distal end of the outer tube 110 , and the distal end of the elastic tube 140 is connected to the proximal end of the wire knife 130 .
  • the elastic function of the elastic tube 140 can help the expansion of the wire knife 130, reduce the extrusion of the balloon 120, and return to the pre-expansion state after the pressure is released, which is beneficial to the catheter from Endovascular withdrawal.
  • the balloon 120 can be made of nylon (PA), polyether block amide (PEBAX) or polyester polymer material.
  • PA nylon
  • PEBAX polyether block amide
  • the outer diameter of the balloon 120 can be adjusted accordingly, which is not limited in the present disclosure and can be determined according to actual conditions.
  • the outer diameter of the balloon 120 may preferably be 1 mm to 30 mm, more preferably 2 mm to 20 mm, further preferably 2 mm to 10 mm, and most preferably 3 mm to 8 mm.
  • the length of the balloon 120 can be adjusted accordingly, which is not limited in the present disclosure. It can be determined according to the actual situation.
  • the length of the balloon 120 can be preferably 5mm-180mm, more preferably 10mm-150mm, and even more preferably 20mm-100mm.
  • a wire cutter 130 includes two or more scoring wires 132 .
  • Each scoring wire 132 is helically wound to form a helical structure. Specifically, each scoring wire 132 is helically wound on the outer surface of the balloon 120 along the axial direction of the balloon 120 . In one embodiment, more than two scoring wires 132 are uniformly distributed along the circumferential direction, arranged parallel to each other and spirally wound in the same direction. Each scoring wire 132 may be equally divided along the circumference of the helical structure. For example, in the embodiment shown in FIG.
  • the wire cutter 130 includes three scoring wires 132, and each scoring wire 132 is arranged in three equal parts along the circumferential direction of the overall helical structure.
  • the cross-section of the scoring wire 132 has at least one sharp angle in the radially outward direction of the helical structure.
  • the number of sharp corners depends on the actual situation, which is not limited in the present disclosure. In one embodiment, the number of sharp corners is one.
  • the pointed design of the scoring wire 132 facilitates the cutting of the vascular lesion by the wire knife 130 when the balloon 120 is expanded.
  • the scoring wire 132 can be made of memory alloy, for example.
  • the side of the scoring wire 132 close to the outer surface of the balloon 120 is a curved surface, and the curved surface is adapted to the shape of the outer surface of the balloon 120 .
  • the curved surface design can make the scoring wire 132 fit the balloon 120 better, so that when the balloon 120 expands or contracts, it is more conducive to the unwinding and tightening of the scoring wire 132, and at the same time, the scoring wire with sharp corners is reduced. 132 Damage to balloon 120.
  • multiple scoring wires 132 can be selected, which is not limited in the present disclosure and can be determined according to the actual situation, preferably 1 to 10, more preferably 3 to 8, and more preferably 3 to 5 root. Adjacent scoring wires 132 are not in contact with each other, and are arranged equidistantly in the circumferential direction of the helical structure. Such a design can improve the cutting efficiency of the balloon device on the vascular lesion on the one hand, and ensure the structural stability of the wire knife 130 on the other hand, so as to ensure the safe operation of each scoring wire 132 .
  • the cross section of the scoring wire 132 is polygon-like, including rectangle-like and triangle-like.
  • the cross section of the scoring wire 132 is preferably a similar isosceles or equilateral triangle. As shown in FIG.
  • the shape of the surface is adapted, and the three sharp corners of the triangular shape are rounded.
  • the scoring wire 132 with a triangular cross-section can quickly cut into the plaque to prevent movement or sliding, and ensure that the expansion position is correct. Compared with other shapes, the triangular structure has better stability. At the same time, because of the sharp stress concentration, it can provide higher cutting force under the same balloon expansion pressure, and it is easier to cut the plaque and complete the treatment.
  • the cross section of the scoring wire 132 may be a polygon, which is not limited in the present disclosure and may be determined according to the actual situation.
  • the polygon is preferably 3-10 sides, more preferably 3-8 sides shape, most preferably 3-pentagonal.
  • the cross section is trapezoidal, which can increase the cutting width; the cross section is pentagonal, which can also increase the cutting width; the cross section is hexagonal, which can increase the cutting speed of the scoring wire 132 . Therefore, different cross-sectional shapes of the scoring wire 132 can be selected according to surgical requirements to obtain corresponding surgical effects.
  • the circumferential winding length of each scoring wire 132 is more than one circle. In a preferred embodiment, when the balloon is in an expanded state, the circumferential winding length of each scoring wire is more than one circle. According to the balloon device of the present disclosure, when the balloon is in an expanded state, a single scoring wire is wound around the outer surface of the balloon for at least one round, so as to ensure that the cutting effect meets the expected requirements.
  • the outer surface of the balloon 120 is spirally provided with more than two grooves 122, the depth of the grooves 122 is equal to or greater than the radial height of the scoring wire 132, and each scoring wire 132 is embedded In one groove 122.
  • the surface of balloon 120 is evenly divided into a plurality of leaf-shaped balloon regions, referred to as leaflets 124 .
  • Grooves 122 are formed between the flaps 124 so that the scoring wires 132 arranged on the surface of the balloon 120 are embedded in the grooves 122 .
  • the number of the grooves 122 corresponds to the scoring wire 132, so it is preferably 1-10, more preferably 3-8, and still more preferably 3-5.
  • the scoring wire 132 when the balloon 120 is in a contracted state, the scoring wire 132 is embedded in the groove 122 and is completely wrapped by the flap 124 without being exposed to the outside.
  • the embodiments of the present disclosure are not limited thereto, and the scoring wire 132 may also be partially embedded in the groove 122 , that is, the scoring wire 132 can still be seen from the surface of the balloon device 120 .
  • the depth of the groove 122 is equal to or greater than the radial height of the scoring wire 132 . That is to say, the sharp corner of each scoring wire 132 will not protrude from the outer surface of the balloon 120 due to the shielding and blocking of the flap 124 .
  • balloon 120 is in a deflated state. Therefore, in the embodiment of the present disclosure, the sharp corners of the scoring wires 132 are at least wrapped or shielded by the flaps 124 of the balloon 120 on both sides of the groove 122, so that the sharp corners of the scoring wires 132 will not directly contact the inner wall of the blood vessel. , so as to prevent the scoring wire 132 from scratching the blood vessel during delivery of the balloon 120 and causing complications.
  • FIG. 2B shows the situation where the flaps 124 of the balloon 120 are fully opened, so that the scoring wire 132 is completely protruding from the outer surface of the balloon 120 as a whole.
  • the embodiments of the present disclosure are not limited thereto, and the leaflets 124 of the balloon 120 may also be partially opened, so that the sharp corners of the scoring wires 132 protrude from the surface of the balloon 120 .
  • the diameter of the helical structure of the scoring wire 132 exceeds the diameter of the outer surface of the balloon 120 , that is, the sharp corner of the scoring wire 132 protrudes from the outer surface of the balloon 120 .
  • the balloon device is delivered to the lesion and starts working, the balloon 120 is in an expanded state. Therefore, the scoring wire 132 expands its outer diameter along with the expansion of the balloon 120, and is exposed from the groove 122 of the balloon 120, so that the scoring wire can directly contact the lesion of the cutting blood vessel, fully ensuring the safety of the wire knife 130. Surgical cutting efficiency.
  • a method of using a balloon device according to an embodiment of the present disclosure is further described below with reference to FIGS. 3A-3D .
  • the balloon 120 is in a contracted state, the diameter of the helical structure of the scored wire 132 does not exceed the diameter of the outer surface of the balloon 120, and the scored wire 132 is embedded in the groove 122 in. Therefore, the sharp corners of the scoring wires 132 are at least hidden or shielded by the flaps 124 of the balloon 120 on both sides of the groove 122, so that the scoring wires 132 with sharp corners will not directly contact the inner wall of the blood vessel, thereby avoiding the incision of the balloon.
  • the scoring wire 132 scratches the blood vessel during delivery of the device, causing complications.
  • the balloon 120 when the balloon device is delivered to the lesion, the balloon 120 gradually expands, so the flaps 124 on its surface gradually open.
  • the scored wire 132 in the groove 122 between the leaf petals is gradually pushed out by the inflated balloon, and the diameter of its helical structure also gradually expands along with the untwisting of the spiral shape of the scored wire, and the balloon 120
  • the outer surface is extended so that the sharp corners of the scoring wire 132 protrude from the outer surface of the balloon 120 .
  • the scoring wire 132 directly contacts the diseased part of the blood vessel, ensuring the cutting efficiency of the wire knife 130 .
  • the cutting depth of the scoring wire 132 on the surface of the balloon 120 can be adjusted by finely adjusting the expansion degree of the balloon 120 .
  • the balloon 120 deflates.
  • the scored wire 132 tightens the spiral again, and the diameter of the helical structure decreases as the balloon 120 shrinks, so that the scored wire 132 is restored to be embedded in the groove 122 again.
  • the sharp corners of the scoring wire 132 are again hidden or blocked by the flaps 124 of the balloon 120 on both sides of the groove 122 .
  • the balloon device will not directly contact the inner wall of the blood vessel because the sharp corner of the scoring wire 132 is blocked during the retracted delivery process, thereby avoiding the scoring wire 132 from scratching the blood vessel during the retracted delivery process. , causing complications.
  • the bonding force between the scoring wire 132 and the balloon 120 is improved in the following manner: first, the balloon is evenly divided into three flap-shaped balloon regions ( Hereinafter referred to as "leaves"), then the three leaf petals are wound and crimped to form a cylinder-like body, and a groove area is formed between adjacent balloon areas, and then the processed wire knife is inserted into the balloon On the surface, the following process passes the wire knife and the balloon through the crimping device, and fills the catheter with pressure under the constraints of a certain outer diameter, and squeezes the balloon leaf into the gap of the wire knife through the pressure; then continue to change the outer diameter of the constraint Small, flatten the balloon leaflet protruding from the wire knife to cover the score wire in the wire knife, so as to ensure that the score wire is embedded in the groove of the balloon, that is, the outer diameter of the tubular shape of the score wire does not exceed The outer diameter of the balloon surface.
  • the scored wire is helically wound on the outer surface of the balloon along the axial direction of the balloon, which improves the overall flexibility of the balloon device equipped with a wire knife, and by
  • the scoring wire covering the wire knife during the delivery of the balloon further improves the flexibility and passability of the balloon device, and avoids scratching the inner wall of normal blood vessels by the balloon device during delivery.
  • the cutting efficiency of the scoring wire on the surface of the balloon is improved through the expansion and expansion of the balloon. Therefore, the balloon device of the embodiment of the present disclosure significantly improves the safety factor of the balloon device and reduces the operation risk.
  • the wire cutter 130 includes two or more scoring wires 132 .
  • the score wire 132 is helically wound to form a helical structure.
  • the wire cutter 130 also includes two end pieces 134, which are respectively arranged at two ends of the helical structure.
  • the end pieces 134 include a ring structure, and the ring structure includes a plurality of U-shaped rods connected end to end. The number of U-shaped bars at either end of the end piece 134 corresponds to the number of scoring wires 132 .
  • U-shaped rods and scoring wires 132 there are three U-shaped rods and scoring wires 132 at any one end of the end piece 134 .
  • the present disclosure is not so limited, and the number of U-shaped bars and scoring wires 132 at either end of the end piece 134 can be adjusted as desired.
  • the number of U-shaped bars at any one end of the end piece 134 is preferably 1-10, more preferably 3-8, and still more preferably 3-5.
  • the U-shaped rod at any one end of the end piece 134 can make the end piece 134 fit tightly on the balloon device, which helps to maintain the overall helical structure of the scoring wire 132 in the wire knife 130 in the delivery and working state, and makes the wire knife 130 is more firmly connected to the distal end of the elastic tube 140 and the distal end of the balloon 120 .
  • the elastic tube 140 is made of elastomeric polymer, including silicone rubber, nylon elastomer, and polyurethane.
  • the wire cutter 130 When the balloon 120 expands, the wire cutter 130 will expand radially and shrink axially with the expansion of the balloon 120, and at the same time, the elastic tube 140 will stretch axially, so that the elastic function of the elastic tube 140 can help the expansion of the wire cutter 130, Ensure that the connection between the wire cutter 130 and the catheter does not break or disengage; when the balloon 120 completes expansion and returns to the compressed state, the wire cutter 130 returns to its original state by virtue of its memory function and the elastic function of the elastic tube 140, which is beneficial to the catheter Withdraw from the blood vessel.
  • the diameter of the annular configuration of the end piece 134 is smaller than the diameter of the helical configuration of the scoring wire 132 . In this way, the end piece 134 can make the overall outer diameter of the balloon device smaller while ensuring the cutting and expansion range of the scoring wire 132, thereby improving the passability and flexibility of the product.
  • the wire cutter 130 also includes two or more connecting rods 136 .
  • the two ends of each connecting rod 136 are respectively connected with a scoring wire and a U-shaped rod, and more than two connecting rods extend along the axial direction of the helical structure and are parallel to each other, thereby connecting each scoring wire 132 to the end piece 134 U-bar connection at either end.
  • the number of connecting rods 136 at either end of the score wire 132 corresponds to the number of score wires 132 .
  • the number of connecting rods 136 at any end of the scoring wire 132 is preferably 1-10, more preferably 3-8, and still more preferably 3-5.
  • the present disclosure does not limit the number of connecting rods 136, which may be determined according to actual conditions.
  • the connecting rod 136 may be elastically deformed accordingly. In this way, it can be beneficial to increase the radial expansion diameter of the scoring wire 132 and prevent the situation that the balloon 120 cannot be fully opened due to the helical locking of one end, and it is also conducive to reducing the binding force of the scoring wire 132 on the balloon 120 and reducing damage. Balloon 120 Risk.
  • the cross section of the U-shaped rod and/or the connecting rod 136 is substantially rectangular, and the four corners of the substantially rectangular shape are rounded.
  • the cross-sectional area of the connecting rod 136 is smaller than that of the U-shaped rod.
  • the cross-section of the U-shaped bar and/or the connecting rod 136 is substantially rectangular, which can improve the supporting performance of the end piece 134 and the connecting rod 136. Since the cross-sectional area of the connecting rod 136 is smaller than that of the U-shaped rod, the stiffness of the U-shaped rod is greater than that of the connecting rod 136 .
  • this ensures that the end piece 134 can maintain the overall helical structure of the scored wire 132 of the wire knife 130 during the inflation process of the balloon 120, improving the overall stability of the structure, and on the other hand, it is also beneficial to the elastic deformation of the connecting rod 136 , which is conducive to increasing the radial expansion diameter of the scoring wire 132 and preventing the helical locking of one end of the balloon 120 resulting in incomplete opening.
  • the side of the scoring wire 132 close to the outer surface of the balloon 120 is a curved surface, and the curved surface is adapted to the shape of the outer surface of the balloon 120 .
  • the curved surface design can make the scoring wire 132 fit the balloon 120 better, so that when the balloon 120 expands or contracts, it is more conducive to the unwinding and tightening of the scoring wire 132, and at the same time, the scoring wire with sharp corners is reduced.
  • 132 Damage to balloon 120 is a curved surface, and the curved surface is adapted to the shape of the outer surface of the balloon 120 .
  • the side of the connecting rod 136 close to the outer surface of the balloon 120 is a curved surface, and the curved surface is adapted to the shape of the outer surface of the balloon 120 .
  • the side of each part of the wire cutter 130 of the present disclosure near the outer surface of the balloon 120 is curved, so that when the wire cutter 130 is installed on the surface of the balloon 120, it can better fit the balloon 120 surface, and at the same time reduce the damage to the balloon 120 caused by various components, especially the scoring wire 132 with sharp corners.
  • the wire cutter 130 can use laser cutting or mechanical processing to cut the metal raw material pipe according to the design drawing to form a wire cutter, and then pickling, sandblasting, polishing, etc. the cut wire cutter Processing technology, finally forming the required wire knife.
  • the material of the wire cutter 130 is preferably nickel-titanium alloy or other related memory materials. Therefore, when the balloon device is finished using, by virtue of the memory function of the material of the wire knife 130, it will quickly return to the initial state of the scored wire, so that the outer diameter of the scored wire 132 is once again captured by the flaps of the balloon 120 on both sides of the groove 122. 124 is hidden or covered, so that the scoring wire 132 with sharp corners does not directly contact the inner wall of the blood vessel, thereby preventing the scoring wire 132 from scratching the blood vessel during the retraction of the balloon 120 and causing complications.
  • Embodiments of the present disclosure provide a balloon device and a wire cutter used for the balloon device.
  • the flexibility and passability of the balloon device are further improved, avoiding It prevents the balloon device from scratching the inner wall of normal blood vessels during delivery, improves the safety factor of the balloon device, and reduces surgical risks.
  • the embodiment of the present disclosure adopts a triangular-like scored wire structure.
  • the sharp corner design is beneficial to the cutting of the vascular lesion by the wire knife when the balloon is expanded.
  • the wire knife due to the stress concentration at the sharp corner, the Under the pressure of balloon expansion, it can provide higher cutting force, and the wire knife can cut the plaque more easily, so as to effectively treat the hardened plaque vascular stenosis.

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Abstract

一种丝刀(130)，包括2根以上刻痕丝(132)、2个端件(134)以及2根以上连接杆(136)。2根以上刻痕丝(132)螺旋缠绕形成螺旋结构。2个端件(134)分别设置在螺旋结构的两端，端件(134)包括环状结构，环状结构包括多个首尾相连的U形杆。2根以上连接杆(136)，每根连接杆(136)的两端分别连接1根刻痕丝(132)和1个U形杆，2根以上连接杆(136)沿螺旋结构的轴向延伸且互相平行。一种球囊装置，包括丝刀(130)、球囊(120)以及外管(110)。球囊(120)具有扩张状态和收缩状态。球囊(120)的近端与外管(110)的远端连接。其中，丝刀(130)的远端与球囊(120)的远端固定连接，刻痕丝沿球囊(120)的轴向螺旋缠绕于球囊(120)的外表面，刻痕丝(132)的横截面在螺旋结构的径向朝外的方向上具有至少一尖角。

Description

一种丝刀和球囊装置
出于所有目的，本申请要求于2021年12月2日递交的中国专利申请第CN202111461399.X号的优先权，在此全文引用上述中国专利申请公开的内容以作为本申请的一部分。
技术领域
本公开涉及球囊，尤其涉及一种丝刀和球囊装置。
背景技术
冠状动脉狭窄是指冠状动脉内膜有脂质等物质沉积、平滑肌细胞增生和胶原纤维增多，导致冠状动脉壁增厚变硬、血管腔狭窄甚至闭塞的病理改变，又称冠心病。当冠心病发展到一定程度，冠状动脉狭窄逐渐加重，限制流入心肌的血流，心脏得不到足够的氧气供给，就会发生胸部不适等症状。随着冠心病发病率增高和经皮冠状动脉介入治疗(PCI)技术的发展，中国PCI手术量近年来增长迅速。目前药物洗脱支架(DES)仍是血管成形术的主导。药物涂层球囊(DCB)作为新的、成熟的介入治疗技术，已被多项临床试验证实其在支架内再狭窄(ISR)、冠状动脉内狭窄病变、小血管病变、分叉病变等方面的疗效和安全性和有效性。
但无论是单纯药物涂层球囊(DCB)治疗还是药物洗脱支架(DES)治疗，预处理都显得格外重要。普通球囊的扩张导致斑块的压缩、破裂及血管弹性扩张，容易出现内膜撕裂甚至急性闭塞，之后出现的弹性回缩和对损伤的增生反应也是血管再狭窄的重要原因。
发明内容
本公开提供一种丝刀和一种球囊装置，其例如提高了球囊装置的通过性和柔顺性，避免了输送过程中球囊装置对正常血管内壁划伤。
本公开提出了一种丝刀，包括2根以上刻痕丝、2个端件以及2根以上连接杆。2根以上刻痕丝螺旋缠绕形成螺旋结构。2个端件分别设置在螺旋结构的两端，端件包括环状结构，环状结构包括多个首尾相连的U形杆。2根以上连接杆，每根连接杆的两端分别连接1根刻痕丝和1个U形杆，2根以上 连接杆沿螺旋结构的轴向延伸且互相平行。
根据本公开的实施例，位于丝刀的两端的端件和刻痕丝之间设有连接杆。连接杆为直线型，在刻痕丝随着球囊膨胀而扩张过程中，连接杆可以随之进行弹性变形。如此，可以有利于增加刻痕丝径向膨胀直径和预防螺旋锁住球囊一端导致不能完全打开的情况出现，也有利于减小刻痕丝对于球囊的束缚力，降低损伤球囊的风险；同时，直线型连接杆对中间螺旋刻痕丝具有轴向作用力，可防止螺旋刻痕丝两端在球囊扩张过程中移位错位，导致刻痕丝分布不均匀甚至出现刻痕丝锁住球囊不能打开的情况，从而可以确保刻痕丝随球囊膨胀均匀扩张。
在一个实施例中，环状结构的直径小于螺旋结构的直径。这样，端件可以更加牢固地固定在球囊的近端和弹性管的远端，而且在保证刻痕丝的切割扩张幅度的同时，可以使球囊装置的整体外径更小，提高产品的通过性和柔顺性。
在一个实施例中，U形杆和/或连接杆的横截面呈类矩形，且连接杆的横截面面积小于U形杆的横截面面积。由于连接杆的横截面面积小于U形杆的横截面积，因此U形杆的刚度大于连接杆的刚度。这一方面保证了U形杆可以在球囊的膨胀过程中维持丝刀的刻痕丝的整体环状形状，提高结构的整体稳定性，另一方面还有利于连接杆的弹性变形，有利于增加刻痕丝径向膨胀直径和预防螺旋锁住球囊一端导致不能完全打开的情况出现。
在一个实施例中，刻痕丝的横截面呈类矩形或类三角形。
在一个实施例中，刻痕丝的横截面呈类等腰三角形或类等边三角形。呈类三角形的横截面的刻痕丝有良好的稳定性，同时具有尖角，在相同球囊扩张压力下可以提供更高的切割力，更容易切开斑块，完成治疗。
在一个实施例中，2根以上刻痕丝沿周向均匀分布且以互相平行的方式排列并同向螺旋缠绕。
本公开还提出了一种球囊装置，包括上述实施例任一个所述的丝刀、球囊以及外管。球囊具有扩张状态和收缩状态。球囊的近端与外管的远端连接。其中，丝刀的远端与球囊的远端固定连接，刻痕丝沿球囊的轴向螺旋缠绕于球囊的外表面，刻痕丝的横截面在螺旋结构的径向朝外的方向上具有至少一尖角。
在一个实施例中，球囊装置还包括弹性管，弹性管设置于外管远端的外 表面，弹性管的远端与丝刀的近端连接。
在一个实施例中，连接杆和/或刻痕丝的靠近球囊的外表面的一侧为曲面，曲面与球囊的外表面的形状适配。这样当丝刀安装在球囊表面上时，可以更好贴合球囊表面，同时降低各个部件尤其是具有尖角的刻痕丝对球囊的损坏。
在一个实施例中，每根刻痕丝周向的缠绕长度为一个圆周以上。
在一个实施例中，当球囊为收缩状态时，球囊的外表面螺旋设置有2条以上凹槽，凹槽的深度等于或大于刻痕丝的径向高度，每根刻痕丝内嵌于1条凹槽中；当球囊为扩张状态时，球囊的外表面延展以使刻痕丝的尖角外凸于球囊的外表面。
根据本公开的实施例，刻痕丝沿球囊的轴向螺旋缠绕于球囊的外表面并内嵌在球囊的凹槽中。刻痕丝螺旋缠绕形成螺旋结构，可以随着螺旋的解旋和紧旋而调整其整体直径。在球囊的输送过程中，球囊处于收缩状态，这样刻痕丝的外径至少被凹槽两侧的球囊的页瓣隐藏或遮挡，使得具有尖角的刻痕丝不会直接接触血管内壁，从而避免在球囊的输送过程中刻痕丝划伤血管，引起并发症。而且，在球囊到达病变部位时，刻痕丝可以随着球囊的膨胀而扩大其外径，而且从球囊的凹槽中暴露出来，从而直接接触血管的病变部位，保证丝刀的切割效率。因此根据本公开的技术方案，可以显著提高球囊装置的安全系数，降低风险。
附图说明
为了更清楚地说明本公开实施例的技术方案，下面将对实施例的附图作简单地介绍，显而易见地，下面描述中的附图仅仅涉及本公开的一些实施例，而非对本公开的限制。
图1为根据本公开的一个实施例的球囊装置的立体示意图。
图2A为图1的球囊装置的截面图，显示了收缩状态的球囊。
图2B为图1的球囊装置的截面图，显示了扩张状态的球囊。
图3A至图3D为根据本公开的一个实施例的球囊装置的使用方法的截面示意图。
图4为根据本公开的一个实施例的丝刀的结构示意图。
具体实施方式
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、完整地描述，显然，所描述的实施例仅仅是本公开一部分实施例，而不是全部的实施例。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。
除非另有定义，本公开实施例使用的所有术语(包括技术和科学术语)具有与本公开所属领域的普通技术人员共同理解的相同含义。还应当理解，诸如在通常字典里定义的那些术语应当被解释为具有与它们在相关技术的上下文中的含义相一致的含义，而不应用理想化或极度形式化的意义来解释，除非本公开实施例明确地这样定义。
本公开实施例中使用的“第一”、“第二”以及类似的词语并不表示任何顺序、数量或者重要性，而只是用来区分不同的组成部分。“一个”、“一”或者“该”等类似词语也不表示数量限制，而是表示存在至少一个。同样，“包括”或者“包含”等类似的词语意指出现该词前面的元件或者物件涵盖出现在该词后面列举的元件或者物件及其等同，而不排除其他元件或者物件。“连接”或者“相连”等类似的词语并非限定于物理的或者机械的连接，而是可以包括电性的连接或通讯连接，不管是直接的还是间接的。
在本公开中定义的“远端”和“近端”说明如下。球囊装置通过人体皮肤穿插后进入人体血管，并沿着人体血管的方向进入到病变部位。以人体皮肤穿插的入口作为基准点，沿球囊的行进方向，远离基准点的一端为远端，靠近基准点的一端为近端。
目前，用于普通血管狭窄的扩张球囊在扩张时会导致斑块的压缩、破裂及血管弹性扩张，容易出现内膜撕裂甚至急性闭塞，之后还会出现的弹性回缩和对损伤的增生反应等其他血管再狭窄的不良反应。
本公开的发明人发现，在一些现有技术方案中，公开了一种切割球囊导管。该切割球囊导管包括导管轴和固定在导管轴的远端部分的可充气球囊。可充气球囊上固定了一种或多种切割刀片。由于切割刀片固定在球囊上，使得球囊坚硬且外径较大，造成球囊的通过性差，限制了球囊进入弯曲血管或较小血管的能力。此外，切割刀片在回撤过程中更容易造成血管损伤，造成手术并发症，导致风险并可能危及性命。
本公开的发明人还发现，在另一些现有技术方案中，公开了在球囊表面包覆金属网，虽然金属网直接包覆在球囊表面，在直线血管内两者可相对紧贴 在一起不会脱落，但当过弯曲血管时，由于切割单元金属丝裸露在外表面，很容易划伤血管内壁，正常血管内壁很容易被划伤，带来新的风险。
因此，本公开的发明人发现上述现有方案中的球囊装置均存在不同程度的不足之处，在临床上应用也有诸多限制。由此，本公开的实施例提供的球囊装置一定程度上解决了上述一些技术问题。
下面结合附图对本公开的实施例及其示例进行详细说明。
图1为根据本公开的一个实施例的球囊装置的立体示意图，图2A和2B分别为球囊在收缩状态和扩张状态的截面图。
如图1所示，球囊装置包括丝刀130、球囊120、外管110以及弹性管140。球囊120具有扩张状态和收缩状态。球囊120的近端与外管110的远端连接，球囊120的远端与丝刀130的远端固定连接。弹性管140设置于外管110远端的外表面，弹性管140的远端与丝刀130的近端连接。当球囊120和丝刀130扩张时，借助弹性管140的弹性功能可以帮助丝刀130的扩张，降低对球囊120的挤压，且泄压后能回到扩张前状态，有利于导管从血管内退出。
在一个实施例中，球囊120可以采用尼龙(PA)或聚醚嵌段酰胺(PEBAX)或聚酯类高分子材料。根据需要，球囊120的外径可以进行相应调整，本公开对此不作限制，可以视实际情况而定。例如，球囊120的外径可以优选为1mm～30mm，更优选为2mm～20mm，再优选为2mm～10mm，最优选为3mm～8mm。球囊120的长度可以进行相应调整，本公开对此不作限制，可以视实际情况而定，球囊120的长度可以优选为5mm～180mm，更优选为10mm～150mm，再优选为20mm～100mm。
参照图1，根据本公开的一个实施例的丝刀130包括2根以上刻痕丝132。每根刻痕丝132螺旋缠绕形成螺旋结构，具体来说，每根刻痕丝132均沿球囊120的轴向螺旋缠绕于球囊120的外表面。在一个实施例中，2根以上刻痕丝132沿周向均匀分布且以互相平行的方式排列并同向螺旋缠绕。每根刻痕丝132可以沿螺旋结构的周向等分排列。例如，图1所示的实施例中，丝刀130包括三根刻痕丝132，每根刻痕丝132沿整体螺旋结构的圆周方向三等分排列。刻痕丝132的横截面在螺旋结构的径向朝外的方向上具有至少一尖角。尖角的数量视实际情况而定，本公开对此不作限制，在一个实施例中，尖角的数量为1。刻痕丝132的该尖角设计有利于在球囊120扩张时丝刀130对于血 管病变部位的切割。刻痕丝132例如可以由记忆合金制成。
在一个实施例中，刻痕丝132的靠近球囊120的外表面的一侧为曲面，该曲面与球囊120的外表面的形状适配。该曲面设计可以使刻痕丝132更好贴合球囊120，从而在球囊120扩张或收缩时更有利于刻痕丝132的解螺旋和收紧螺旋，同时降低具有尖角的刻痕丝132对球囊120的损坏。
在一个实施例中，刻痕丝132可以选用多根，本公开对此不作限制，可以视实际情况而定，优选为1～10根，更优选为3～8根，再优选为3～5根。相邻刻痕丝132互不接触，并按照螺旋结构的周向等距设置。这样的设计可以一方面提高球囊装置对血管病变部分的切割效率，另一方面确保丝刀130的结构稳定性，保证每根刻痕丝132的安全工作。
在一个实施例中，刻痕丝132的横截面呈类多边形，包括类矩形、类三角形。刻痕丝132的横截面优选为类等腰或类等边三角形，如图2A所示，刻痕丝132的靠近球囊120的外表面的一侧为曲面，该曲面与球囊120的外表面的形状适配，类三角形为三角形的三个尖角呈倒圆角设计。呈类三角形的横截面的刻痕丝132可以快速切入斑块防止移动或滑动，确保扩张位置准确无误。该三角形结构相比于其他形状结构有更好的稳定性，同时因为有尖角应力集中，在相同球囊扩张压力下可以提供更高的切割力，更容易切开斑块，完成治疗。在另一个实施例中，刻痕丝132的横截面可以是多边形，本公开对此不作限制，可以视实际情况而定，例如，多边形优选为3～10边形，更优选为3～8边形，最优选为3～5边形。其中横截面为梯形，能够提高切割宽度；横截面为五边形，也能够提高切割宽度；横截面为六边形，能够提高刻痕丝132的切割速度。因此，可以根据手术需要选择不同的刻痕丝132的横截面形状，来获得相应的手术效果。
在一个实施例中，每根刻痕丝132周向的缠绕长度为一个圆周以上。在一个优选的实施例中，当球囊为扩张状态时，每根刻痕丝周向的缠绕长度为一个圆周以上。根据本公开的球囊装置，在球囊呈扩张状态时，单根刻痕丝在球囊外表面周向缠绕最少满足一周，从而确保切割效果满足预期要求。
当球囊120为收缩状态时，球囊120的外表面螺旋设置有2条以上凹槽122，凹槽122的深度等于或大于刻痕丝132的径向高度，每根刻痕丝132内嵌于1条凹槽122中。在本公开的实施例中，球囊120的表面均匀分成多个页瓣形状的球囊区域，被称之为页瓣124。在页瓣124之间形成凹槽122，从 而布置在球囊120表面的刻痕丝132镶嵌在该凹槽122中。凹槽122的数量与刻痕丝132对应，因此其优选为1～10个，更优选为3～8个，再优选为3～5个。当球囊120为扩张状态时，球囊120的外表面延展以使刻痕丝132的尖角外凸于球囊120的外表面。
如图1和图2A所示，在球囊120为收缩状态时，刻痕丝132镶嵌在凹槽122中，被页瓣124完全包裹而不暴露于外部。但本公开的实施例并不限于此，刻痕丝132也可以部分镶嵌在凹槽122中，即从球囊装置120的表面仍可见刻痕丝132。在球囊120为收缩状态时，凹槽122的深度等于或大于刻痕丝132的径向高度。也就是说，每根刻痕丝132的尖角由于页瓣124的遮挡和阻挡不会从球囊120的外表面突出。在球囊装置的输送过程中，球囊120为收缩状态。因此在本公开的实施例中，刻痕丝132的尖角至少被凹槽122两侧的球囊120的页瓣124包裹或遮挡，使得具有尖角的刻痕丝132不会直接接触血管内壁，从而避免在球囊120的输送过程中刻痕丝132划伤血管，引起并发症。
如图2B所示，在球囊120为扩张状态时，随着球囊120的体积膨胀，其表面的页瓣124张开，球囊120的外表面延展以使刻痕丝132的尖角外凸于球囊120的外表面。图2B示出了球囊120的页瓣124完全张开从而刻痕丝132整体完全外凸于球囊120的外表面的情形。而本公开的实施例并不限于此，球囊120的页瓣124也可以部分张开，使得刻痕丝132的尖角部分突出于球囊120的表面。换言之，在球囊120为扩张状态时，刻痕丝132的螺旋结构的直径超过球囊120的外表面的直径，即刻痕丝132的尖角外凸于球囊120的外表面。在球囊装置被输送到病变部位开始工作时，球囊120为扩张状态。因此刻痕丝132随着球囊120的扩张而扩大其外径，从球囊120的凹槽122中暴露出来，使得刻痕丝可以直接接触切割血管的病变部位，充分保证了丝刀130的手术切割效率。
下面参照图3A-3D进一步描述根据本公开的实施例的球囊装置的使用方法。
如图3A所示，在球囊装置的输送过程中，球囊120为收缩状态，刻痕丝132的螺旋结构的直径不超过球囊120的外表面的直径，刻痕丝132镶嵌在凹槽122中。因此，这样刻痕丝132的尖角至少被凹槽122两侧的球囊120的页瓣124隐藏或遮挡，使得具有尖角的刻痕丝132不会直接接触血管内壁， 从而避免在球囊装置的输送过程中刻痕丝132划伤血管，引起并发症。
如图3B和3C所示，在球囊装置被输送到病变部位时，球囊120逐渐扩张，因此其表面的页瓣124逐渐张开。这时位于页瓣之间的凹槽122中的刻痕丝132逐渐被膨胀的球囊推出，其螺旋结构的直径也随着刻痕丝的螺旋形状的解旋而逐渐扩大，球囊120的外表面延展以使刻痕丝132的尖角外凸于球囊120的外表面。从而刻痕丝132直接接触血管的病变部位，保证丝刀130的切割效率。在球囊装置的使用过程中，可以通过精细调节球囊120的扩张程度来调节位于球囊120表面的刻痕丝132的切割深度。
如图3D所示，当球囊装置完成使用时，球囊120进行放气收缩。根据刻痕丝132的记忆合金的材料性能，刻痕丝132再次收紧螺旋，其螺旋结构的直径随球囊120的收缩而减小，使得刻痕丝132再次恢复镶嵌在凹槽122中。在这种状态下，刻痕丝132的尖角再次被凹槽122两侧的球囊120的页瓣124隐藏或遮挡。在这种状态下，球囊装置在回撤的输送过程中，由于刻痕丝132的尖角被遮挡而不会直接接触血管内壁，避免了回撤的输送过程中刻痕丝132划伤血管，引起并发症。
根据本公开的实施例，通过以下方式来提高刻痕丝132和球囊120之间的结合力：首先通过折翼设备把球囊在真空条件下均匀分成3个页瓣形状的球囊区域(以下称为“页瓣”)，接着对3个页瓣进行卷绕压握形成一个类圆柱体，相邻的球囊区域之间形成凹槽区域，接着把加工完成的丝刀套入球囊表面，后面工序把丝刀与球囊通过压握设备，在一定外径束缚下往导管内充盈压力，通过压力把球囊页瓣挤压到丝刀的缝隙中；接着继续把束缚外径变小，把冒出丝刀的球囊页瓣压扁来覆盖住丝刀中的刻痕丝，这样来确保刻痕丝镶嵌在球囊凹槽中，即刻痕丝的管状形状的外径不超过球囊表面的外径。
综上所述，根据本公开实施例的球囊装置，刻痕丝沿球囊的轴向螺旋缠绕于球囊的外表面，提高了装有丝刀的球囊装置的整体柔性，而且通过在球囊输送过程中遮蔽丝刀的刻痕丝，进一步提高了球囊装置柔顺性和通过性，避免了输送过程中球囊装置对正常血管内壁划伤。而且，通过球囊的扩张膨胀作用，提高了球囊表面的刻痕丝的切割效率。因此本公开实施例的球囊装置显著提高了球囊装置的安全系数，降低手术风险。
下面将参照图1和图4更详细地描述根据本公开的实施例的丝刀130。如图1和图4所示，丝刀130包括2根以上刻痕丝132。刻痕丝132螺旋缠绕形 成螺旋结构。丝刀130还包括2个端件134，其分别设置在螺旋结构的两端，端件134包括环状结构，该环状结构包括多个首尾相连的U形杆。端件134任意一端的U形杆的数量对应于刻痕丝132的数量。在图4中，端件134任意一端的U形杆与刻痕丝132的数量均为三个。本公开并不限于此，端件134任意一端的U形杆和刻痕丝132的数量可以根据需要进行调整。端件134任意一端的U形杆的数量优选为1～10个，更优选为3～8个，再优选为3～5个。端件134任意一端的U形杆可以使得端件134紧密地套装在球囊装置上，有助于保持丝刀130中的刻痕丝132在输送和工作状态的整体螺旋结构，而且使得丝刀130更牢固地与弹性管140的远端和球囊120的远端连接。弹性管140的材料为高弹体聚合物，包括硅橡胶、尼龙弹性体、聚氨酯。球囊120扩张时丝刀130会随着球囊120的膨胀而径向扩张和轴向微缩，同时弹性管140轴向拉伸，从而借助弹性管140的弹性功能可以帮助丝刀130的扩张，确保丝刀130与导管的连接不出现断裂或脱离；当球囊120完成扩张，变回压缩状态后，丝刀130凭借其记忆功能以及弹性管140的弹性功能均恢复至初始状态，有利于导管从血管内退出。
在一个实施例中，端件134的环状结构的直径小于刻痕丝132的螺旋结构的直径。这样，端件134可以在保证刻痕丝132的切割扩张幅度的同时，使球囊装置的整体外径更小，提高产品的通过性和柔顺性。
丝刀130还包括2根以上连接杆136。每根连接杆136的两端分别连接1根刻痕丝和1个U形杆，2根以上连接杆沿螺旋结构的轴向延伸且互相平行，从而将每根刻痕丝132与端件134任意一端的U形杆连接。刻痕丝132任意一端的连接杆136的数量对应于刻痕丝132的数量。例如，刻痕丝132任意一端的连接杆136的数量优选为1～10根，更优选为3～8根，再优选为3～5根。本公开对连接杆136的数量不作限制，可以视实际情况而定。根据本公开的实施例，在刻痕丝132随着球囊120膨胀而解螺旋扩张过程中，连接杆136可以随之进行弹性变形。如此，可以有利于增加刻痕丝132径向膨胀直径和预防螺旋锁住球囊120一端导致不能完全打开的情况出现，也有利于减小刻痕丝132对于球囊120的束缚力，降低损伤球囊120的风险。
在一个实施例中，U形杆和/或连接杆136的横截面呈类矩形，且类矩形的四个角呈倒圆角设计。连接杆136的横截面面积小于U形杆的横截面面积。U形杆和/或连接杆136的横截面呈类矩形可以提高端件134和连接杆136的 支撑性能。由于连接杆136的横截面面积小于U形杆的横截面积，因此U形杆的刚度大于连接杆136的刚度。这一方面保证了端件134可以在球囊120的膨胀过程中保持丝刀130的刻痕丝132的整体螺旋结构，提高结构的整体稳定性，另一方面还有利于连接杆136的弹性变形，有利于增加刻痕丝132径向膨胀直径和预防螺旋锁住球囊120一端导致不能完全打开的情况出现。
在一个实施例中，刻痕丝132的靠近球囊120的外表面的一侧为曲面，该曲面与球囊120的外表面的形状适配。该曲面设计可以使刻痕丝132更好贴合球囊120，从而在球囊120扩张或收缩时更有利于刻痕丝132的解螺旋和收紧螺旋，同时降低具有尖角的刻痕丝132对球囊120的损坏。在一个实施例中，U形杆靠近球囊120的外表面的一侧为曲面，该曲面与球囊120的外表面的形状适配。在一个实施例中，连接杆136靠近球囊120的外表面的一侧为曲面，该曲面与球囊120的外表面的形状适配。作为一个示例，本公开的丝刀130的各个部件靠近球囊120的外表面的一侧均为曲面，这样，当丝刀130安装在球囊120表面上时，可以更好贴合球囊120表面，同时降低各个部件尤其是具有尖角的刻痕丝132对球囊120的损坏。
在一个实施例中，丝刀130可采用激光切割或机械加工等方式对金属原料管材按照设计图进行切割加工形成丝刀，然后对切割加工好的丝刀进行酸洗、喷砂、抛光等后处理工艺，最终形成所需的丝刀。丝刀130的材料优选为镍钛合金或其他相关记忆性材料。因而，当球囊装置完成使用时，凭借丝刀130材料的记忆功能，快速恢复至刻痕丝初始状态，这样刻痕丝132的外径再次被凹槽122两侧的球囊120的页瓣124隐藏或遮挡，使得具有尖角的刻痕丝132不会直接接触血管内壁，从而避免在球囊120的回撤过程中刻痕丝132划伤血管，引起并发症。
本公开的实施例提供了一种球囊装置和用于球囊装置的丝刀，通过在球囊输送过程中遮蔽丝刀的刻痕丝，进一步提高了球囊装置柔顺性和通过性，避免了输送过程中球囊装置对正常血管内壁划伤，提高了球囊装置的安全系数，降低手术风险。本公开的实施例采用类三角形的刻痕丝结构，其尖角设计一方面有利于在球囊扩张时丝刀对于血管病变部位的切割，另一方面，由于存在尖角应力集中，在相同球囊扩张压力下可以提供更高的切割力，丝刀更容易切开斑块，从而有效地治疗硬化斑块血管狭窄疾。
有以下几点需要说明：
(1)本公开实施例附图只涉及到本公开实施例涉及到的结构，其他结构可参考通常设计。
(2)在不冲突的情况下，本公开的实施例及实施例中的特征可以相互组合以得到新的实施例。
以上所述，仅为本公开的具体实施方式，但本公开的保护范围并不局限于此，本公开的保护范围应以所述权利要求的保护范围为准。

Claims (11)

  1. 一种丝刀，其特征在于，包括：
    2根以上刻痕丝，螺旋缠绕形成螺旋结构；
    2个端件，分别设置在所述螺旋结构的两端，所述端件包括环状结构，所述环状结构包括多个首尾相连的U形杆；以及
    2根以上连接杆，每根所述连接杆的两端分别连接1根所述刻痕丝和1个所述U形杆，所述2根以上连接杆沿所述螺旋结构的轴向延伸且互相平行。
  2. 根据权利要求1所述的丝刀，其特征在于，所述环状结构的直径小于所述螺旋结构的直径。
  3. 根据权利要求1所述的丝刀，其特征在于，所述U形杆和/或所述连接杆的横截面呈类矩形，且所述连接杆的横截面面积小于所述U形杆的横截面面积。
  4. 根据权利要求1所述的丝刀，其特征在于，所述刻痕丝的横截面呈类矩形或类三角形。
  5. 根据权利要求1所述的丝刀，其特征在于，所述刻痕丝的横截面呈类等腰三角形或类等边三角形。
  6. 根据权利要求1所述的丝刀，其特征在于，所述2根以上刻痕丝沿周向均匀分布且以互相平行的方式排列并同向螺旋缠绕。
  7. 一种球囊装置，其特征在于，包括：
    根据权利要求1-6任一项所述的丝刀；
    球囊，所述球囊具有扩张状态和收缩状态；以及
    外管，所述球囊的近端与所述外管的远端连接，
    其中，所述丝刀的远端与所述球囊的远端固定连接，所述刻痕丝沿所述球囊的轴向螺旋缠绕于所述球囊的外表面，所述刻痕丝的横截面在所述螺旋结构的径向朝外的方向上具有至少一尖角。
  8. 根据权利要求7所述的球囊装置，其特征在于，还包括弹性管，所述弹性管设置于所述外管远端的外表面，所述弹性管的远端与所述丝刀的近端连接。
  9. 根据权利要求7所述的球囊装置，其特征在于，所述连接杆和/或所述刻痕丝的靠近所述球囊的外表面的一侧为曲面，所述曲面与所述球囊的外表 面的形状适配。
  10. 根据权利要求7所述的球囊装置，其特征在于，每根所述刻痕丝周向的缠绕长度为一个圆周以上。
  11. 根据权利要求7所述的球囊装置，其特征在于，当所述球囊为所述收缩状态时，所述球囊的外表面螺旋设置有2条以上凹槽，所述凹槽的深度等于或大于所述刻痕丝的径向高度，每根所述刻痕丝内嵌于1条所述凹槽中；当所述球囊为所述扩张状态时，所述球囊的外表面延展以使所述刻痕丝的所述尖角外凸于所述球囊的外表面。
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