WO2019024726A1 - 药物涂层球囊导管 - Google Patents

药物涂层球囊导管 Download PDF

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Publication number
WO2019024726A1
WO2019024726A1 PCT/CN2018/096902 CN2018096902W WO2019024726A1 WO 2019024726 A1 WO2019024726 A1 WO 2019024726A1 CN 2018096902 W CN2018096902 W CN 2018096902W WO 2019024726 A1 WO2019024726 A1 WO 2019024726A1
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WO
WIPO (PCT)
Prior art keywords
drug
catheter
coated balloon
sheath
balloon
Prior art date
Application number
PCT/CN2018/096902
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English (en)
French (fr)
Inventor
张庭超
李敬
Original Assignee
杭州唯强医疗科技有限公司
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Publication of WO2019024726A1 publication Critical patent/WO2019024726A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • 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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
    • 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 invention belongs to the technical field of medical instruments, and relates to an interventional medical device, in particular to a drug-coated balloon catheter.
  • Arterial stenosis is a common type of disease.
  • the treatment of arterial stenosis mainly includes the use of naked balloon dilatation, implantation of a bare stent or drug stent in the lesion.
  • the drug-coated balloon catheter refers to a balloon catheter loaded with a drug coating on the surface of a common bare balloon. After the balloon to be loaded with the drug is delivered to the lesion, the balloon is expanded to restore the blood vessel wall of the lesion to a smooth state. The drug coating elutes from the surface of the balloon and is released to the blood vessel wall, which further inhibits the proliferation of smooth muscle cells and prevents restenosis of blood vessels. Therefore, the drug-coated balloon catheter can not only establish a channel for blood flow through balloon expansion, but also avoid defects such as in-stent restenosis and thrombus after stent implantation.
  • the prior art drug-coated balloon catheter usually uses a balloon catheter having only one balloon, a drug coating is applied to the outer surface of the balloon, and the drug-loaded balloon is delivered to the lesion site according to the lesion site.
  • the characteristics of the expansion are as high as 50% or more due to the high-speed flow of blood, thereby reducing the amount of drug-coated balloon that can be released in the lesion.
  • Device effectiveness is as high as 50% or more due to the high-speed flow of blood, thereby reducing the amount of drug-coated balloon that can be released in the lesion.
  • the present invention provides a drug-coated balloon catheter having a high drug utilization rate.
  • the embodiments of the present invention provide the following technical solutions:
  • the present invention provides a drug coated balloon catheter comprising:
  • At least one first drug-coated balloon fixedly disposed at a distal end of the push catheter
  • the drug-coated balloon catheter of the present invention is movable relative to the push catheter by adding a sheath to accommodate each of the first drug-coated balloons in the The sheath is exposed or exposed outside the sheath, thereby avoiding the flushing of the drug coating by the blood flow during the delivery process, thereby effectively reducing the drug loss rate during the delivery process and improving the effectiveness of the drug-coated balloon catheter.
  • FIG. 1 is a schematic structural view of a drug-coated balloon catheter provided by a first embodiment of the present invention
  • Figure 2 is a schematic view showing the structure of the sheath of Figure 1 retracted
  • Figure 3 is a cross-sectional view of the drug-coated balloon catheter of Figure 1 taken along the line III-III;
  • Figure 4a is a schematic structural view of an embodiment of the sheath of Figure 1;
  • FIG. 4b is a schematic structural view of another embodiment of the sheath of FIG. 1;
  • Figure 5 is a schematic structural view of a shrink cover of the sheath of Figure 1;
  • Figure 6 is a schematic view showing the structure of the shrink cover of the sheath of Figure 1 in an open state
  • FIG. 7 is a schematic structural view of a drug-coated balloon catheter provided by a second embodiment of the present invention.
  • FIG. 8-10 are schematic structural views of the push catheter of Fig. 7;
  • FIG. 11 is a schematic structural view of a drug-coated balloon catheter according to a third embodiment of the present invention.
  • Figure 12 is a cross-sectional view of the drug-coated balloon catheter of Figure 11 taken along the line XII-XII;
  • Figure 13 is a schematic view showing the structure of the first embodiment of the locking mechanism of the drug-coated balloon catheter of Figure 11;
  • Figure 14 is a schematic view showing the structure of a second embodiment of the locking mechanism of the drug-coated balloon catheter of Figure 11;
  • FIG. 15 to FIG. 19 are schematic views showing the use process of the drug-coated balloon catheter of FIG. 11, wherein FIG. 15 is a schematic view of the drug-coated balloon catheter reaching the blood vessel of the lesion, and FIG. 16 is a sheath retraction, drug coating. Schematic diagram of the balloon being exposed in the blood vessel, FIG. 17 is a schematic view after adjusting the position of the second balloon, FIG. 18 is a schematic view showing the expansion of the second balloon, and FIG. 19 is a schematic view showing the expansion of the drug-coated balloon;
  • FIG. 20 is a schematic structural view of an embodiment of a drug-coated balloon catheter according to a fourth embodiment of the present invention.
  • Figure 21a is a cross-sectional view of the embodiment of the drug-coated balloon catheter of Figure 20 taken along the line XXI-XXI;
  • Figure 21b is a cross-sectional view of another embodiment of the drug coated balloon catheter of Figure 20 taken along the line XXI-XXI;
  • FIG. 22 is a schematic structural view of another embodiment of the drug-coated balloon catheter of FIG. 20;
  • FIG. 23-25 are schematic views of the structure of the drug-coated balloon catheter of Fig. 20.
  • the end of the device near the operator is generally referred to as the proximal end (ie, the operating end), and the end of the device away from the operator is referred to as the distal end (ie, the insertion end).
  • the insertion end refers to one end of the instrument inserted into the animal or human body.
  • the operator end refers to the end that is operated by the user or the machine.
  • the use of the terms first, second, etc. does not mean any order or importance, but the terms first, second, etc. are used to distinguish one element from another.
  • Embodiments of the present invention provide a drug coated balloon catheter comprising a push catheter, at least one drug coated balloon disposed at a distal end of the push catheter, and a sheath movably disposed outside the drug coated balloon.
  • the drug coated balloon includes an expandable balloon and an active drug coating at least partially covering the surface of the expandable balloon.
  • the sheath moves in the axial direction of the pusher catheter.
  • the drug coated balloon is contained within the sheath prior to expansion.
  • the drug coated balloon catheter 1000 includes a drug coated balloon 100, a sheath 220, and a push device 300.
  • the push device 300 includes a distal end (ie, an insertion end) and a proximal end (ie, an operation end) that are disposed opposite each other.
  • the drug coated balloon 100 is fixedly disposed at the distal end of the push device 300 and housed within the sheath 220.
  • the sheath 220 is movable relative to the push device 300 such that each drug coated balloon 100 is received within the sheath 220 or exposed outside the sheath such that loading of the drug coated balloon 100 is accomplished by the movement of the sheath 220.
  • the push device 300 includes a pusher catheter 310 having a certain axial length.
  • the distal end corresponding portion of the push catheter 31 is housed in the sheath 220.
  • a drug coated balloon 100 is secured to the distal end of the push catheter 310.
  • the manner in which the drug-coated balloon 100 is fixed may be soldered, bonded, or fixed by a fixing member, and the like.
  • the drug coated balloon 100 is wrapped in the sheath 220 after being wrapped and wound.
  • the drug coated balloon 100 is generally elliptical.
  • the opposite ends of the drug-coated balloon 100 are tapered.
  • the drug coated balloon 100 includes a working section 11.
  • the working section 11 is disposed in the middle of the drug coated balloon 100.
  • the working section 11 is substantially cylindrical, so that after the drug-coated balloon 100 is expanded, the fit of the working section 11 to the blood vessel of the lesion can be achieved.
  • the drug coated balloon 100 has a length ranging from 30 to 320 mm.
  • the working section 11 has a diameter ranging from 2 to 15 mm.
  • the length of the working section 11 (i.e., the effective length of the drug coated balloon 100) ranges from 20 to 300 mm.
  • the effective length refers to the length that can be attached to the inner wall of the blood vessel after the balloon is expanded.
  • the size and effective length of the drug-coated balloon 100 can be selected according to the diameter of the blood vessel of the lesion to be expanded.
  • the drug coated balloon 100 includes a balloon body 20 and a drug coating 30 overlying the outer surface of the balloon body 20. It will be appreciated that in one embodiment, the drug coating 30 covers the outer surface of the unitary balloon body 20. In another embodiment, the drug coating 30 can partially cover the outer surface of the balloon body 20.
  • the balloon body 20 is an expandable balloon. Specifically, in the present embodiment, the balloon body 20 can selectively inflate or dispense liquid, thereby improving the adherence of the drug-coated balloon 100.
  • the drug coating 30 is disposed at a position corresponding to the working section 11 of the balloon body 20.
  • the active drug coating 30 contains the active drug.
  • the active drug layer 30 further includes a carrier.
  • the carrier can be used to promote rapid release of the active drug from the outer surface of the balloon body 20 or to promote absorption of diseased tissue.
  • the carrier is, for example, but not limited to, an organic acid salt or a polyhydric alcohol, and mannitol is used as a carrier in this embodiment.
  • the active drug is a drug having a function of inhibiting smooth muscle cell proliferation (e.g., paclitaxel, rapamycin, etc.), and paclitaxel is used in the present embodiment.
  • the active drug coating 30 is formed on the balloon body 20 mainly by coating, and the coating method is an existing conventional coating technique, which will not be described herein.
  • the cylindrical working section 11 of the drug-coated balloon 100 ensures that the filled drug-coated balloon 100 has good adherence and is effective in transferring the active drug to the inner wall of the blood vessel of the lesion.
  • the pusher catheter 310 passes axially through both ends of the drug-coated balloon 100 and is sealingly coupled to the drug-coated balloon 100.
  • the push catheter 310 has a first portion 311 housed within the balloon body 20 and a second portion 312 that is exposed outside of the balloon body 20.
  • the guide wire chamber 1 and the first filling chamber 2 are disposed in the axial direction inside the pusher catheter 310.
  • the guide wire lumen 1 is isolated from the first filling chamber 2 and arranged side by side.
  • the guidewire lumen 1 is for receiving and passing a guidewire.
  • the first filling chamber 2 is for introducing or withdrawing liquid into the drug-coated balloon 100 to fill or depressurize the balloon body 20.
  • the guidewire lumen 1 extends axially through the distal and proximal ends of the push catheter 310.
  • the first filling chamber 2 is in communication with the balloon body 20 of the drug coated balloon 100. It can be understood that in other embodiments, the user can set one or more guide wire lumens 1 and the first filling lumen 2 inside the push catheter 310 according to the actual state of the diseased tissue and the time required for filling.
  • the push device 300 further includes a catheter hub 320 disposed at the proximal end of the push catheter 310.
  • the catheter hub 320 is provided with a guide wire port 15 and a first filling port 16.
  • the guide wire port 15 is in communication with the guide wire lumen 1.
  • the guidewire lumen 1 and the guidewire port 15 are for receiving and passing the guidewire.
  • the first portion 311 of the push catheter 310 is provided with a balloon filling port 101 that penetrates the first filling chamber 2.
  • the first filling chamber 2 is in communication with the first filling port 16 and the balloon filling port 101.
  • the opposite ends of the first filling chamber 2 are in communication with the first filling port 16 and the balloon filling port 101, respectively.
  • the first filling port 16, the first filling chamber 2, and the balloon filling port 101 form a passage for filling or relieving the drug-coated balloon 100.
  • the external pressure pump is connected through the first filling port 16, and the pressurized liquid enters or flows out of the drug-coated balloon 100 through the first filling port 16, the first filling chamber 2 and the balloon filling port 101 to realize the drug-coated balloon 100. Filling or deflation.
  • the first portion 311 of the pusher catheter 310 is also provided with a development positioning device 111.
  • the development positioning device 111 is made of a radiopaque material and is used for positioning of the drug coated balloon 100 during surgery.
  • the development positioning device 111 is preferably disposed on the push catheter 310 corresponding to the working section 11 of the drug coated balloon 100, that is, disposed in the first portion 311 of the push catheter 310.
  • the development positioning device 111 can be in various forms such as a ring shape, a wire shape, a belt shape or a dot shape, and is fixed on the push conduit 310 by a technique commonly used in the art such as pressure grip, hot melt, bonding, welding or press riveting. .
  • the sheath 220 is movably sleeved on the push catheter 310 and houses the drug-coated balloon 100 for performing the active drug coating 30 on the outer surface of the drug-coated balloon 100. protection.
  • the sheath 220 is movable in the axial direction of the pusher catheter 310.
  • the drug coated balloon 100 is received within the sheath 220 prior to expansion.
  • the sheath 220 is preferably tubular in shape and can be placed over the exterior of the flap and wound drug coated balloon 100.
  • the inner diameter of the sheath 220 is greater than the maximum outer diameter of the drug coated balloon 100 after the expansion of the flap and the wound is 0 to 0.10 mm.
  • the sheath 220 is preferably made of a material having a small coefficient of friction such as e-PTFE, PTFE, FEP or PET.
  • the sheath 220 is provided with a shrink cover 210 near the distal end of the push catheter 310.
  • the shrink cover 210 is substantially in the shape of a truncated cone.
  • the diameter of the shrink cap 210 tapers away from the distal end of the push catheter 310, i.e., the shrink cap 210 gradually gathers toward the distal end and receives the distal end of the push catheter 310.
  • the shrink cap 210 can cover the distal end of the sheath 220 or be attached to the distal end of the sheath 220.
  • the shrink cover 210 is provided with at least one expansion joint 211 in the axial direction. When the expansion joint 211 is opened, the drug-coated balloon 100 projects from the side of the sheath 220 near the distal end and is exposed to the outer circumference of the sheath 220.
  • the smallest diameter of the expansion joint 211 is smaller than the maximum diameter of the drug coated balloon 100.
  • the expansion joint 211 is preferably provided in a tearable structure, that is, the expansion joint 211 of the shrink cover 210 does not penetrate the outer side wall of the shrink cover 210. Specifically, before the expansion joint 211 is unfolded, the shrink sleeves 210 on both sides of the expansion joint 211 are at least partially connected. At this time, the distal end of the shrink cover 210 is only allowed to pass through the distal end of the push catheter 310, and the drug-coated balloon 100 is Can't stretch out.
  • the sheath 220 can protect the drug coating 30 on the outer surface of the drug coated balloon 100, reducing drug loss caused by erosion of blood within the blood vessel.
  • the sheath 220 is withdrawn (ie, the sheath 220 is moved proximally relative to the push catheter 310) and the telescoping cover 210 is distracted by the drug-coated balloon 100 until it is torn.
  • the distal opening of the shrink cap 210 is increased in diameter such that the drug-coated balloon 100 received in the sheath 220 can protrude from the distal end of the sheath 220 and the distal end of the shrink cap 210 and be exposed to the blood vessel of the lesion.
  • the drug-coated balloon 100 is then filled and expanded, and the active drug coating 30 is released from the outer surface of the balloon body 20 and transferred to the inner wall of the blood vessel of the lesion.
  • the material of the bellows 210 may be the same as or different from the material of the sheath 220. In order to simplify the production process, it is preferable to integrally form the same material.
  • the proximal end of the sheath 220 is further disposed to be sleeved on the push catheter 310 operating handle 230 .
  • the operating handle 230 is used to control the sheath 220 to slide in the axial direction of the pusher catheter 310.
  • the sheath 220 is coupled to the operating handle 230.
  • the proximal end of the sheath 220 can be directly coupled to the operating handle 230.
  • FIG. 4a in an embodiment, the proximal end of the sheath 220 can be directly coupled to the operating handle 230.
  • the proximal end of the sheath 220 can also be indirectly coupled to the operating handle 230 by the hollow tubular body 240, and the hollow tubular body 240 is movably fitted outside of the pusher catheter 310.
  • the drug coated balloon 100 is received within the sheath 220 to protect the drug coating 30 from blood scouring.
  • the handle 230 is retracted proximally, so that the sheath 220 slides in the axial direction toward the proximal end.
  • the shrink cap 210 at the distal end of the sheath 220 is opened, and the drug-coated balloon 100 is opened. Exposed from the shrink cover 210.
  • the number of drug coated balloons 100 may also be multiple to simultaneously expand multiple lesions.
  • FIG. 7 is a drug-coated balloon catheter provided by a second embodiment of the present application.
  • the structure of the drug-coated balloon catheter 2000 is similar to that of the drug-coated balloon catheter 1000 of the first embodiment, and thus the size, element name, and component name of the drug-coated balloon catheter 2000 are included.
  • the positional relationship of each component and the like can be referred to the drug-coated balloon catheter 1000, and will not be described herein.
  • the drug-coated balloon catheter 2000 includes two drug-coated balloons 100 fixedly disposed at the distal end of the push-tube 310, and the catheter hub 320 is provided with a first filling port 16 and a second filling port 16'. And the inside of the push duct 310 is disposed axially with the first filling chamber 2 and the second filling chamber 2'.
  • the pushing device 300 includes a pusher catheter 310.
  • the two drug coated balloons 100 include a first drug coated balloon 110 and a second drug coated balloon 120.
  • the push catheter 310 sequentially penetrates the second drug-coated balloon 120 and the first drug-coated balloon 110 and is sealingly coupled to the first drug-coated balloon 110 and the second drug-coated balloon 120.
  • the first drug coated balloon 110 is placed in series and spaced apart from the second drug coated balloon 120.
  • the mutual position between the first drug-coated balloon 110 and the second drug-coated balloon 120 is not limited, and both need to be located at the distal end of the push catheter 310.
  • the axial distance between the first drug-coated balloon 110 and the second drug-coated balloon 120 may be zero, or may be set at a certain distance according to the spacing of the lesions.
  • a guide wire lumen 1, a first filling chamber 2 and a second filling chamber 2' for accommodating and passing the guide wire are respectively provided in the axial direction of the pusher catheter 310.
  • the first filling chamber 2 and the second filling chamber 2' are in communication with the lumens of the corresponding first drug-coated balloon 110 and second drug-coated balloon 120, respectively.
  • the guide wire chamber 1, the first filling chamber 2 and the cavity of the second filling chamber 2' are disposed apart from each other.
  • the pusher catheter 310 can be an integrally formed multi-lumen tube (as shown in Figures 8 and 9) or assembled with multiple tubes (as shown in Figure 10).
  • an integrally formed multi-lumen tube is used as the pusher catheter 310.
  • the pusher catheter 310 is provided with a mutually spaced guide wire lumen 1, a first filling chamber 2 and a second filling chamber 2'.
  • the cross-sectional shape of the multi-lumen tube is not limited, and only three functional cavities are required to be parallel to each other and not connected to each other.
  • the guide wire cavity 1 is used for wearing the guide wire. Therefore, the guide wire cavity 1 needs a smooth cavity and a shape to facilitate the movement of the guide wire.
  • the cross section of the guide wire cavity 1 is selected from a circular or elliptical shape.
  • the cross-sectional shape of the first filling chamber 2 and the second filling chamber 2' is not limited, and may be any shape, and generally has a maximum cross-sectional area according to the cross-sectional shape of the pushing duct 310 and the position and shape of the guide wire cavity 1.
  • the first filling chamber 2 and the second filling chamber 2' facilitate rapid filling or pressure relief of the drug coated balloon.
  • the pusher catheter 310 includes an outer tube 31a and an inner tube 31b that are nested and secured together to form a pusher catheter 310.
  • the lumen of the inner tube 31a serves as the guide lumen 1.
  • a space between the inner tube 31a and the outer tube 31b and a lumen provided in the outer tube 31b serve as a first filling chamber 2 and a second filling chamber 2', respectively.
  • the push catheter 310 can also be assembled with a plurality of tubes to form the push catheter 310.
  • the shape and diameter of the first drug-coated balloon 110 and the second drug-coated balloon 120 may be the same or different.
  • the first drug coated balloon 110 and the second drug coated balloon 120 are generally cylindrical or spherical in shape and have a diameter selected according to the diameter of the blood vessel. It can be understood that the setting of the two drug-coated balloons can not only simultaneously treat different lesions, but also, after one of the drug-coated balloons is filled, the drug-coated balloon can also block blood flow. The role of avoiding the drug coating on the surface of another drug-coated balloon is washed away by blood flow. In this case, the active drug coating may not be placed on the first filled balloon to reduce the cost of the device.
  • the proximal end of the push catheter 310 is provided with a catheter hub 320.
  • the catheter hub 320 is provided with a guidewire port 15, a first filling port 16, and a second filling port 16'.
  • the guide wire port 15 is in communication with the guide wire lumen 1. Thereby, the guide wire is movably threaded through the guidewire port 15 and the channel formed by the guidewire lumen 1.
  • the push catheter 310 includes two first portions 311 respectively correspondingly packaged in the first drug-coated balloon 110 and the second drug-coated balloon 120, and a barely disposed first drug-coated balloon 110 and a second drug-coated ball. A second portion 312 external to the bladder 120.
  • the two first portions 311 of the pusher catheter 310 respectively open the first balloon filling port 101 and the second balloon filling port 101'.
  • the proximal end and the distal end of the first filling chamber 2 are in communication with the first filling port 16 and the first balloon filling port 101, respectively.
  • the proximal end and the distal end of the second filling chamber 2' are in communication with the second filling port 16' and the second balloon filling port 101', respectively.
  • the first filling port 16, the first filling chamber 2, and the second balloon filling port 101 form a passage for filling or depressurizing the first drug-coated balloon 110.
  • the second filling port 16', the second filling chamber 2' and the second balloon filling port 101' form a passage for filling or relieving the second drug-coated balloon 120.
  • the pusher catheter 310 is respectively provided with at least one developing positioning device 111 on the two first portions 311 corresponding to the working segments 11 of the first drug-coated balloon 110 and the second drug-coated balloon 120, so as to be passed under the detection of the instrument.
  • the position of the development positioning device 111 is displayed to indicate the balloon position.
  • the development positioning device 111 may be made of a radiopaque developing material and has a structure such as a ring, a filament, a ribbon, a dot, or a sheet.
  • the development positioning device 111 is preferably in the form of a developing ring.
  • the development positioning device 111 may be provided one or more separately.
  • the fixing manner of the developing and positioning device 111 may be a general technical means in the art such as welding, bonding, hot pressing, and riveting, and will not be described herein.
  • the slidable sheath has a protective effect on the drug coating on the surface of the balloon, which can reduce the rate of drug loss during the delivery process;
  • FIG. 11 illustrates a drug coated balloon catheter according to a third embodiment of the present invention.
  • the structure of the drug-coated balloon catheter 3000 is similar to that of the drug-coated balloon catheter 2000 of the second embodiment, and thus the size, element name, and component of the drug-coated balloon catheter 3000 are included.
  • the positional relationship of each component and the like can be referred to the drug-coated balloon catheter 2000, and will not be described herein.
  • the drug coated balloon catheter 3000 further includes a sliding catheter 340 that slides relative to the push catheter 310 and a locking mechanism 500 that connects the push catheter 310 and the sliding catheter 340.
  • the first drug coated balloon 110 is fixedly disposed on the push catheter.
  • the second drug-coated balloon 120 is fixedly disposed on the sliding catheter 340.
  • the distance between the first drug-coated balloon 110 and the second drug-coated balloon 120 can be adjusted.
  • the pushing device 300 includes a pushing duct 310 and a sliding duct 340 that is movably sleeved on the outside of the pushing duct 310 and that can move relative to the pushing duct 310 in the axial direction.
  • At least one first drug coated balloon 110 is fixedly disposed at a distal end of the push catheter 310.
  • At least one second drug coated balloon 120 is provided at the distal end of the sliding catheter 340. The distance between the first drug-coated balloon 110 and the second drug-coated balloon 120 can be adjusted.
  • the number of sliding catheters 340 can be set according to actual conditions, and generally preferably 1-2, correspondingly, the second drug-coated balloon 120 at the distal end of each sliding catheter 340 The number can also be set to one or more, and it is generally preferable to set 1-2.
  • the distal end of the push catheter 310 is disposed coaxially with the distal end of the sliding catheter 340, that is, the first drug coated balloon 110 and the second drug coated balloon 120 are disposed coaxially.
  • the distal end of the push catheter 310 and the distal end of the sliding catheter 340 can also be disposed in parallel.
  • the first drug-coated balloon 110 and the second drug-coated balloon 120 are spaced apart from each other.
  • the sheath 220 is operatively sleeved on the exterior of the first drug-coated balloon 110 and the second drug-coated balloon 120, ie, the first drug-coated balloon 110 and the second drug-coated balloon 120 are expanded prior to expansion. Both are housed in the sheath 220.
  • the distal end of the sheath 220 is provided with a shrink cap 210.
  • At least one expansion joint (not shown) is disposed on the shrink cover 210.
  • the structure of the sheath 220 is substantially the same as that of the sheath 220 of the first embodiment, and details are not described herein again.
  • the interior of the push catheter 310 is axially disposed with a mutually unobstructed guide wire lumen 1 and a first filling for filling or decompressing the first drug-coated balloon 110. Cavity 2.
  • the proximal end of the push catheter 310 is provided with a catheter hub 320.
  • the catheter hub 320 is provided with a first filling port 16.
  • the first portion 311 of the push catheter 310 is provided with a first balloon filling port 101.
  • the proximal end and the distal end of the first filling chamber 2 are in communication with the first filling port 16 and the first balloon filling port 101, respectively.
  • the first balloon filling port 101, the first filling chamber 2, and the first filling port 16 form a passage for filling and relieving the second drug-coated balloon 120.
  • the interior of the sliding duct 340 is axially provided with a second filling chamber 4 for filling or decompressing the second drug-coated balloon 120.
  • the second filling chamber 4 is in communication with the lumen of the second drug-coated balloon 120.
  • the cross-sectional shape of the sliding duct 340 is related to the push duct 310 penetrating therethrough, and since the push duct 310 takes up a large space, the second filling chamber 4 is disposed in the side space of the push duct 310.
  • An adjustment handle 330 is provided at the proximal end of the sliding duct 340.
  • the adjustment handle 330 is provided with a second filling port 17.
  • the sliding catheter 340 includes a first portion 341 that is encapsulated within the second drug-coated balloon 120 and a second portion 342 that is exposed outside of the second drug-coated balloon 120.
  • the first portion 341 of the sliding catheter 340 is provided with a second balloon filling port 103.
  • the proximal end and the distal end of the second filling chamber 4 are in communication with the second filling port 17 and the second balloon filling port 103, respectively.
  • the second balloon filling port 103, the second filling chamber 4, and the second filling port 17 form a passage for filling and relieving the second drug-coated balloon 120.
  • the second drug coated balloon 120 is welded or bonded to the sliding catheter 340.
  • the structure and shape of the second drug-coated balloon 120 may be the same as or different from the first drug-coated balloon 110.
  • the second drug-coated balloon 120 can be a conventional balloon or a drug-coated balloon that is at least partially coated with a drug coating.
  • the second drug-coated balloon 120 can also be used as a occlusion balloon in addition to the expansion of the lesion, that is, the second drug-coated balloon 120 is first filled and expanded, and the blood vessel is blocked to avoid the first drug. After the coated balloon 110 protrudes from the sheath 220, the active drug coating 30 is flushed by the blood. It will be appreciated that the surface of the second drug-coated balloon 120 for occluding blood vessels is preferably not provided with an active drug coating.
  • the size of the first drug-coated balloon 110 and the second drug-coated balloon 120 depends on the diameter of the blood vessel to be expanded, and is not specifically limited. However, when the second drug-coated balloon 120 is used to occlude a blood vessel, the diameter of the second drug-coated balloon 120 should be slightly larger than the diameter of the first drug-coated balloon 110 such that the second drug-coated balloon 120 After the device is filled into the lesion, it is expanded earlier than the first drug-coated balloon 110, thereby blocking blood flow and avoiding blood flow to the active drug coating 30 on the outer surface of the first drug-coated balloon 110.
  • the sliding duct 340 is disposed coaxially with the pushing duct 310, that is, the sliding duct 340 of the tubular structure is arbitrarily sleeved outside the pushing duct 310, the overall outer diameter of the balloon duct can be reduced, space is saved, the push is facilitated, and the passability is improved. .
  • At least one of the outer surface of the pusher catheter 310 and/or the inner surface of the sliding duct 340 is preferably a smooth surface that facilitates sliding.
  • the smooth surface may be directly coated with a lubricating coating on the surface, for example, a lubricating material such as silicone or polyvinylpyrrolidone is coated on the outer surface of the pusher catheter 310.
  • the smooth surface may also be made of a push conduit 310 or/and a sliding conduit 340 using a material having a low coefficient of friction.
  • a locking mechanism 500 is disposed between the sliding duct 340 and the push duct 310 .
  • the sliding guide 340 is pushed distally or proximally to adjust between the first drug-coated balloon 110 and the second drug-coated balloon 120.
  • the relative position between the push catheter 310 and the sliding catheter 340 can be fixed by the locking mechanism 500, so that the relative position between the first drug-coated balloon 110 and the second drug-coated balloon 120 can be fixed.
  • the locking mechanism 500 has various embodiments, which are specifically described as follows:
  • a first embodiment of the locking mechanism 500 the sliding catheter 340 is movably sleeved outside of the push catheter 310.
  • the locking mechanism 500 is an elastic locking member that is fixed to the sliding duct 340.
  • the elastic locking member rotates and holds the push catheter 310 to lock the sliding catheter 340 and the push catheter 310.
  • the specific structure of the elastic locking member is that the elastic locking member includes a positioning tube 510 fixed on the sliding duct 340 and a hand wheel 530 screwed to the positioning tube 510.
  • the positioning tube 510 is sleeved and fixed to the proximal end of the sliding catheter 340, and the positioning tube 510 is closer to the proximal end of the sliding catheter 340 than the adjustment handle 330.
  • a cylindrical, elastic elastic sleeve 520 is disposed between the positioning tube 510 and the push tube 310. In the free state, the elastic sleeve 520 is slidably engaged or gap-fitted with the pusher catheter 310.
  • the hand wheel 530 is coupled to a top ram 540 that is inserted into the positioning tube 510. By rotating the hand wheel 530, the pressing head 540 can be driven to move in the direction of the elastic sleeve 520 and press the elastic sleeve 520.
  • the elastic sleeve 520 After the elastic sleeve 520 is pressed, it is deformed, radially extended and axially contracted, and the outer surface of the pushing duct 310 is hung. Thereby, the sliding duct 340 is locked with the pushing duct 310; by rotating the hand wheel 530 in the reverse direction, the pressing head 540 is moved away from the elastic sleeve 520, the elastic sleeve 520 is no longer pressed, and the elastic elastic sleeve 520 is restored to a free state. The lock between the slide duct 340 and the push duct 310 is released.
  • the resilient locking member can also be secured to the pusher catheter 310. The resilient locking member rotates and catches the sliding guide 340 to lock it with the pusher catheter 310.
  • the locking mechanism 500 includes a first locking member 51 disposed on the pushing catheter 310 and a second locking member 52 disposed on the sliding catheter 340, and first The locking member 51 is detachably coupled to the second locking member 52.
  • first locking member 51 and the second locking member 52 are in the separated state, the pushing conduit 310 and the sliding conduit 340 are axially movable relative to adjust the first drug-coated balloon 110 and the second drug-coated ball. The distance between the capsules 120.
  • the pushing conduit 310 and the sliding conduit 340 are not axially movable relative to each other, and the first drug-coated balloon 110 and the second drug-coated balloon 120 are The distance between them is also fixed.
  • the detachable connection between the first locking member 51 and the second locking member 52 is a screw connection or a snap connection.
  • the first locking member 51 is fixed to the pushing duct 310, and the first locking member 51 is provided with an external thread 55.
  • the second locking member 52 is fixedly fixed to the sliding duct 340, and the second locking member 52 is provided with an internal thread 56.
  • the first locking member 51 and the second locking member 52 are detachably connected by threads.
  • the limit fixing of the second locking member 52 means that the second locking member 52 can only rotate in the original position on the sliding guide 340 and cannot move axially.
  • 15 to 19 illustrate a process for treating a vascular lesion site using the drug-coated balloon catheter 3000 provided by the third embodiment of the present invention, as follows:
  • the distal portion of the drug-coated balloon catheter is first delivered to the vicinity of the lesion location of the blood vessel 900, and the first drug-coated balloon 110 is aligned with the first lesion;
  • Step 2 Referring to Figure 16, the sheath 220 is withdrawn proximally, the expansion joint 211 on the shrink cap 210 is opened, and the first drug-coated balloon 110 and the second drug-coated balloon 120 are respectively exposed to the blood vessel. 900 in.
  • the fourth step Referring to FIG. 18, the second drug-coated balloon 120 is filled, and the filled second drug-coated balloon 120 fully expands the blood vessel of the second lesion, and blocks blood flow of the blood vessel. .
  • Step 5 Referring to FIG. 19, the first drug-coated balloon 110 is filled, and after the first drug-coated balloon 110 is filled, the blood vessel of the first lesion is fully expanded, and the drug is coated from the first drug coating. The surface of the balloon 110 is released and transferred to the blood vessel wall to exert a pharmacological effect. Thereafter, the first drug-coated balloon 110 and the second drug-coated balloon 120 are respectively released from pressure, and the patient is withdrawn from the patient to complete the operation. It can be understood that the order of the second step and the third step can be exchanged as long as the two balloons are respectively exposed from the sheath.
  • the slidable sheath has a protective effect on the drug coating on the surface of the balloon, which can reduce the rate of drug loss during the delivery process;
  • the second balloon can be used as a balloon to temporarily block the blood flow in the blood vessel, further avoiding the blood scouring of the active drug coating on the surface of the drug-coated balloon, reducing the drug loss rate, and improving the drug self-ball
  • the distance between the second balloon and the drug-coated balloon catheter can be locked by the locking mechanism, which is convenient for the user to perform subsequent operations.
  • a drug coated balloon catheter according to a fourth embodiment of the present invention is provided.
  • the structure of the drug-coated balloon catheter 4000 is similar to that of the drug-coated balloon catheter 3000 of the third embodiment, and thus the size, element name, and component of the drug-coated balloon catheter 4000 are included.
  • the positional relationship of each component and the like can be referred to the drug-coated balloon catheter 3000, and will not be described herein.
  • the difference is that the positional relationship between the pusher catheter 310 and the slide duct 340 of the drug-coated balloon catheter 4000 is different from that of the pusher catheter 310 and the slide catheter 340 of the third embodiment.
  • the distal end of the drug coated balloon catheter 4000 includes a first push branch 313 and a second push branch 314.
  • the first push branch 313 is disposed at the distal end of the push catheter 310
  • the second push branch 314 is disposed at the distal end of the slide catheter 340.
  • the first push branch 313 is coupled to the push catheter 310 with the distal end of the first drug coated balloon 110 disposed.
  • the second push branch 314 connects the sliding catheter 340 with the distal end of the second drug coated balloon 120.
  • the connection can be by fixed connection or integral molding.
  • the distal end of the push catheter 310 forms an angle a with the distal end of the sliding catheter 340.
  • the angle ⁇ between the axial direction of the first push branch 313 and the axial direction of the second push branch is (0°, 180°), that is, the angle ⁇ is 180° ⁇ ⁇ >0°.
  • the angle of the angle ⁇ is set based on the angle between the two branches of the human body is generally not more than 180°, so that the first push branch 313 and the second push branch 314 respectively respectively apply the first drug-coated balloon 110 and the second drug.
  • the coated balloon 120 is fed into the two branch vessels of the bifurcated vessel.
  • the sliding catheter 340 is moved axially relative to the push catheter 310.
  • the relative position of the balloon catheter can be adjusted to make the use of the balloon catheter more flexible, and the second drug-coated balloon 120 can be adjusted according to the position of the second drug-coated balloon 120 and the lesion after the second drug-coated balloon 120 enters the branch.
  • the slide duct 340 is movably disposed inside the push duct 310, or the push duct 310 and the slide duct 340 are juxtaposed.
  • the sliding duct 340 is sleeved on the outside of the pushing duct 310, that is, the pushing duct 310 is movably disposed inside the sliding duct 340.
  • the tubular body sidewall of the sliding duct 340 is provided with a through hole 318 at the intersection of the first pushing branch 313 and the second pushing branch 314.
  • the distal end of the pusher catheter 310 passes through the through hole 318 and is coupled to the second push branch 314.
  • the pushing catheter 310 and the sliding catheter 340 can move relative to each other in the axial direction, and the second pushing branch 314 is moved to the distal end or the proximal end to adjust the position of the second drug-coated balloon 120 to adapt to different structures.
  • the sliding duct 340 can also be arranged side by side with the pushing duct 310, and the two are connected by the limiting member 350 so that the two are only mutually moved in the axial direction.
  • the stop 350 can be in a variety of ways: for example, the push conduit 310 and the slide conduit 340 can be worn in the loop hoop to limit radial movement therebetween.
  • the pusher catheter 310 and the sliding catheter 340 can be nested together in a limit tube having a length to limit radial movement therebetween.
  • the shape of the push catheter 310 and the sliding catheter 340 should cooperate to form a complete, non-angular shape, such as a circular or elliptical shape.
  • FIG. 21a a cross-sectional view of the push catheter 310 in the XXI-XXI direction, the inside of the sliding duct 340 is axially disposed with at least one second filling chamber 4, the distal end of the second filling chamber 4 and the second drug coating
  • the interior of the layer balloon 120 is in communication.
  • a guide wire lumen 1 extending to the distal end of the first push branch 313 and a first filling chamber 2 for filling and decompressing the first drug-coated balloon 110 are disposed axially within the push catheter 310.
  • the first filling chamber 2 extends to the first drug coated balloon 110 of the first push branch 313.
  • the interior of the sliding catheter 340 is also axially disposed with a second guidewire lumen 3, and a second inflation lumen 4 for filling and relieving pressure of the second drug-coated balloon 120.
  • the second guidewire lumen 3 extends to the distal end of the second push-on branch 314, and the second inflation lumen 4 extends to the second drug-coated balloon 120 of the second push-over branch 314.
  • the second guide wire lumen 3 and the second filling chamber 4 are disposed apart.
  • the first filling chamber 2 communicates axially from within the push conduit 310 with the interior of the first drug-coated balloon 110 located distally of the first push-branch 313.
  • the second filling chamber 4 communicates axially from within the sliding conduit 340 with the interior of the second drug coated balloon 120 at the distal end of the second push branch 314.
  • the drug coated balloon catheter 4000 includes a sheath 220. Specifically, the outer portion of the push catheter 310 is sleeved with a sheath 220.
  • the sheath 220 When the first drug-coated balloon 110 and the second drug-coated balloon 120 are not expanded, the two are simultaneously retracted and received in the sheath 220, that is, the sheath 220 simultaneously sets the first drug-coated balloon 110 and the first The two drug coated balloons 120 are protected together.
  • the drug coated balloon catheter 5000 includes a first sheath 220 and a second sheath 240.
  • the first drug-coated balloon 110 is received in the first sheath 220
  • the second drug-coated balloon 120 is received in the second sheath 240.
  • the first sheath 220 is movably disposed on the push catheter 310 and sleeved outside the first drug coating 110.
  • the second sheath 240 is movably disposed on the sliding catheter 340 and sleeved outside the second drug-coated balloon 120, and the second sheath 240 moves in the axial direction of the sliding catheter 310.
  • the first drug-coated balloon 110 is received within the first sheath 220 prior to expansion, and the second drug-coated balloon 120 is received within the second sheath 240 prior to expansion.
  • the first sheath 220 and the second sheath 240 are each independently disposed, wherein the first sheath 220 is fitted over the push catheter 310 and the first drug-coated balloon 110.
  • the second sheath 240 fits over the outside of the sliding catheter 340 and the second drug coated balloon 120. Both the second sheath 240 and the sliding catheter 340 are nested within the push catheter 310.
  • the second sheath 240 is connected at its proximal end with a handle 260 for operating the second sheath 240 to be withdrawn.
  • the first drug-coated balloon 110 is sent to the first branch vessel, and the second drug-coated balloon 120 is sent to the second branch vessel by moving the sliding catheter 340, and then retracted respectively.
  • the sheath 220 and the second sheath 240, the first drug-coated balloon 110 and the second drug-coated balloon 120 are respectively exposed to the vascular environment, and then the first drug-coated balloon 110 and the second drug coating are applied.
  • the balloon 120 is filled and expanded, respectively, to treat the first branch vessel and the second branch vessel.
  • the remaining structure of the first sheath 220 and the second sheath 240 is substantially the same as that of the sheath 220 of the first embodiment, and details are not described herein again.
  • the size specifications of the first drug-coated balloon 110 and the second drug-coated balloon 120 are determined according to the diameter of the blood vessel to be expanded, and are not specifically limited.
  • the number of the first drug-coated balloon 110 and the second drug-coated balloon 120 is at least one, respectively.
  • the first drug-coated balloon 110 and the second drug-coated balloon 120 are each disposed one, the first drug-coated balloon 110 and the second drug-coated balloon 120 are respectively disposed at the first push branch 313 and The second end of the second push branch 314.
  • the adjacent two first drug-coated balloons 110 and each adjacent two second drug-coated balloons 120 can be set in close proximity or at intervals.
  • the pushing duct 310 and the sliding duct 340 are respectively provided with a third filling chamber and a fourth filling chamber for filling and releasing pressure of each of the first drug-coated balloon 110 and each of the second drug-coated balloons 120 (not shown) ).
  • the proximal diameter of the working section 115 of the first drug coated balloon 110 and/or the second drug coated balloon 120 is greater than the diameter of the outer ring portion of the working section 115 of the balloon.
  • the working section 115 of the first drug-coated balloon 110 and/or the second drug-coated balloon 120 refers to a portion in the blood vessel that is attached to the inner wall of the blood vessel for dilating the blood vessel.
  • the reason for this arrangement is that after the first drug-coated balloon 110 and the second drug-coated balloon 120 are respectively pushed into the two branch vessels of the bifurcated blood vessel, the first drug-coated balloon 110 and the second The proximal end of the working section 115 of the drug-coated balloon 120 is simultaneously located at the bifurcation position of the bifurcated vessel, and the diameter of the vessel at the bifurcation position is necessarily less than the sum of the diameters of the two branch vessels.
  • the blood vessel tearing at the bifurcation position is caused.
  • the sum of the proximal end of the working section 115 of the first drug-coated balloon 110 and the proximal end of the working section 115 of the second drug-coated balloon 120 is smaller than the first drug-coated balloon 110 and the second drug-coated balloon.
  • the sum of the diameters of the remaining sections of the 120 working section 115 is smaller than the first drug-coated balloon 110 and the second drug-coated balloon.
  • the length of the working segment 115 is the effective length of the balloon, which determines the therapeutic effect of the balloon on the expansion of the blood vessel.
  • the proximal end diameter of the working section 115 of the second drug-coated balloon 120 of the present embodiment is smaller than the diameter of the remainder of the working section 115 of the balloon, but the second drug-coated ball is compared to a conventional tapered balloon.
  • the balloon 120 still has a longer effective length, so that after filling, the ability to expand the vessel wall of the branch vessel is higher.
  • the diameter of the proximal end of the working section of the second drug-coated balloon 120 that is less than the diameter of the peripheral portion of the working section 115 of the second drug-coated balloon 120, it may be the working section of the first drug-coated balloon 110.
  • the proximal diameter is smaller than the diameter of the peripheral portion of the working section 115 of the first drug-coated balloon 110, or the proximal diameter of the working section of the first drug-coated balloon 110 is smaller than the working section of the first drug-coated balloon 110.
  • the remainder of the diameter, and the proximal diameter of the working section of the second drug-coated balloon 120 are each smaller than the diameter of the remainder of the working section of the second drug-coated balloon 120, respectively.
  • the portion of the first drug-coated balloon 110 near the proximal end or/and the portion of the second drug-coated balloon 120 near the proximal end tapers from the distal end to the proximal end.
  • the proximal end portion and the distal end portion of the first drug-coated balloon 110 are both a tapered structure 116 and a centrally-shaped working section 115.
  • the second drug-coated balloon 120 is generally tapered such that the proximal diameter of the second drug-coated balloon 120 is small and the distal end of the second drug-coated balloon 120 has a large diameter.
  • the proximal end 123 and the distal end 121 of the second drug-coated balloon 120 are both tapered, and the central portion 122 of the second drug-coated balloon 120 has a cylindrical structure, a cylindrical structure and a tapered structure. Smooth transition between.
  • the proximal end 123 and the distal end 121 of the second drug-coated balloon 120 have a generally conical configuration, and the central portion 122 of the second drug-coated balloon 120 has a generally cylindrical configuration with a diameter of the cylindrical structure and
  • the tapered structures have different diameters to form a stepped structure.
  • the tapered structure of the proximal end 121 of the second drug-coated balloon 120 is generally a long-conical structure, that is, the taper change is small, forming a long-length tapered tube having a small diameter, and the tapered diameter is relative to the cylinder. The shape is much smaller.
  • the tapered, long tapered structure can increase the spacing between the first drug-coated balloon 110 and the second drug-coated balloon 120, avoiding the fit or small spacing between the two after filling, vasodilation transition, and vessel tearing Crack or form a sandwich.
  • the surface coating of the second drug-coated balloon 120 can also be provided with an active drug coating.
  • the active drug coating is disposed primarily on the outer surface of the cylindrical working section 115.
  • the second drug coated balloon 120 may also be provided without an active drug coating.
  • the slidable sheath has a protective effect on the drug coating on the surface of the balloon, which can reduce the rate of drug loss during the delivery process;
  • the relative position between the drug-coated balloon and the second balloon can be adjusted, and can better adapt to multiple branch vessels of the bifurcated blood vessel and different lesion positions;
  • the second balloon can be set to an irregular shape to avoid tearing the blood vessel at the bifurcation position
  • the relative position between the second balloon and the drug-coated balloon catheter can be locked by the locking mechanism, which is convenient for the user to perform the next operation.
  • the drug-coated balloon catheter of the present invention avoids the scouring of the drug coating by blood flow by providing a slidable sheath on the outside of the drug-coated balloon, thereby effectively reducing drug loss during transportation. Rate, improve the effectiveness of the drug-coated balloon; at the same time, it can prevent the detached drug from being washed by the blood to the distal blood vessel and block the blood vessel; in addition, the initial drug loading on the drug balloon surface can be reduced due to the reduced drug loss rate. It reduces the metabolic burden of the body and improves the safety of the drug-coated balloon.

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Abstract

一种药物涂层球囊导管(1000)，包括推送导管(310)、至少一第一药物涂层球囊(100)及护套(220)。推送导管(310)具有相对的近端和远端，各所述第一药物涂层球囊(100)固定地设置在所述推送导管(310)的远端，所述护套(220)相对所述推送导管(310)可活动，以使各所述第一药物涂层球囊(100)收容在所述护套(220)内或裸露在所述护套(220)外。该药物涂层球囊导管(1000)通过增设护套(220)，从而避免输送过程中血流对药物涂层的冲刷，进而有效降低输送过程中的药物损失率，提高药物涂层球囊导管的有效性。

Description

药物涂层球囊导管 技术领域
本发明属于医疗器械技术领域，涉及介入医疗器械，具体涉及一种药物涂层球囊导管。
背景技术
动脉血管狭窄是一类常见疾病，动脉血管狭窄的治疗方式主要包括在病变部位使用裸球囊扩张、植入裸支架或者药物支架等方式。药物涂层球囊导管是指在普通的裸球囊表面负载药物涂层的球囊导管，待载有药物的球囊输送至病变部位后，球囊扩张使得病变部位的血管壁恢复畅通，同时药物涂层自球囊表面洗脱并释放至血管壁，可进一步抑制平滑肌细胞的增生，防止血管再狭窄。因此，药物涂层球囊导管不仅可通过球囊扩张为血运建立通道，而且可避免支架植入术后的支架内再狭窄、血栓等缺陷。
然而，现有技术的药物涂层球囊导管通常使用仅具有一个球囊的球囊导管，在该球囊的外表面施加药物涂层，再将载药球囊输送至病变部位后根据病变部位的特点进行扩张。但是这种药物涂层球囊导管在血管内的输送过程中，由于受到高速流动的血液冲刷，药物损失率高达50％以上，从而降低药物涂层球囊在病变部位可释放的药量，影响器械有效性。
发明内容
鉴于现有技术中存在的上述问题，本发明提供一种药物利用率较高的药物涂层球囊导管。为了实现上述目的，本发明实施方式提供如下技术方案：
本发明提供一种药物涂层球囊导管，包括：
推送导管，具有相对的近端和远端；
至少一第一药物涂层球囊，固定地设置在所述推送导管的远端；及
护套，所述护套相对所述推送导管可活动，以使各所述第一药物涂层球囊收容在所述护套内或裸露在所述护套外。
相较于现有技术，本发明的药物涂层球囊导管，通过增设护套，所述护套相对所述推送导管可活动，以使各所述第一药物涂层球囊收容在所述护套内或裸露在所述护套外，从而可避免输送过程中血流对药物涂层的冲刷，进而有效地降低输送过程中的药物损失率，提高药物涂层球囊导管的有效性。
附图说明
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1是本发明第一实施例提供的药物涂层球囊导管的结构示意图；
图2是图1中的护套后撤的结构示意图；
图3是图1中的药物涂层球囊导管沿III-III方向的剖视图；
图4a是图1中的护套的一实施方式的结构示意图；
图4b是图1中的护套的另一实施方式的结构示意图；
图5是图1中的护套的收缩罩的结构示意图；
图6是图1中的护套的收缩罩处于张开状态的结构示意图；
图7是本发明第二实施例提供的药物涂层球囊导管的结构示意图；
图8-10是图7中的推送导管的结构示意图；
图11是本发明第三实施例提供的药物涂层球囊导管的结构示意图；
图12是图11中的药物涂层球囊导管沿XII-XII方向的剖视图；
图13是图11中的药物涂层球囊导管的锁定机构的第一实施方式结构示意图；
图14是图11中的药物涂层球囊导管的锁定机构的第二实施方式结构示意图；
图15至图19是图11中的药物涂层球囊导管的使用过程示意图，其中，图15是药物涂层球囊导管到达病变部位血管的示意图，图16是护套后撤，药物涂层球囊暴露在血管中的示意图，图17是调整第二球囊位置后的示意图，图18是第二球囊扩张的示意图，图19是药物涂层球囊扩张的示意图；
图20是本发明第四实施例提供的药物涂层球囊导管的一实施方式的结构示意图；
图21a是图20中的药物涂层球囊导管的一实施方式沿XXI-XXI方向的剖视图；
图21b是图20中的药物涂层球囊导管的另一实施方式沿XXI-XXI方向的剖视图；
图22是图20中的药物涂层球囊导管的另一实施方式的结构示意图；
图23-25是图20中的药物涂层球囊导管的结构示意图。
具体实施方式
为了对本发明的技术特征、目的和效果有更加清楚的理解，现对照附图详细说明本发明的具体实施方式。显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实 施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
首先需要说明的是，在介入医疗领域，通常将器械靠近操作者的一端称作近端(也即操作端)，将器械远离操作者的一端称作远端(也即插入端)。具体的，插入端是指器械插入到动物或人体体内的一端。操作端是指供用户或机器操作的一端。此外，术语第一、第二等的使用不是指任何顺序或重要性，而是使用术语第一、第二等来将一个元件与另一元件区别开来。
本发明实施例提供了一种药物涂层球囊导管，包括推送导管、至少一个设于推送导管远端的药物涂层球囊、及活动地套设于药物涂层球囊外部的护套。药物涂层球囊包括可扩张球囊及至少部分覆盖可扩张球囊表面的活性药物涂层。护套沿推送导管的轴向运动。药物涂层球囊在扩张前收容于护套内。
根据药物涂层球囊导管结构的不同，有以下几种实施方式，通过以下实施例进行详细说明。
请参见图1及图2，为本发明第一实施例提供的药物涂层球囊导管。药物涂层球囊导管1000包括药物涂层球囊100、护套220及推送装置300。推送装置300包括相对设置的远端(也即插入端)和近端(也即操作端)。药物涂层球囊100固定地设置在推送装置300的远端，且收容于护套220内。护套220相对推送装置300可活动，以使各药物涂层球囊100收容在护套220内或裸露在护套外，从而通过护套220的活动可实现将药物涂层球囊100装载的药物输送至病变部位，也即护套220的活动可使药物涂层球囊100伸出护套220并暴露于病变部位，例如血管，进而降低血流对药物涂层的冲刷，并且提高输送过程中的药物利用率。
在本实施例中，推送装置300包括具有一定轴向长度的推送导管310。推送导管31的远端对应部分收容于护套220内。推送导管310的远端固定一个药物涂层球囊100。药物涂层球囊100的固定方式可以是焊接、粘接或通过固定件固定等本领域通用技术手段，在此不再赘述。药物涂层球囊100折翼并卷绕后收容于护套220中。药物涂层球囊100大致呈椭圆形。药物涂层球囊100相对的两端部均为锥形。药物涂层球囊100包括工作段11。工作段11设置在药物涂层球囊100的中部。工作段11大致呈圆柱形，从而药物涂层球囊100扩张后，可实现工作段11与病变部位的血管的贴合。药物涂层球囊100的长度范围为30-320mm。工作段11的直径范围为2-15mm。工作段11的长度(即，药物涂层球囊100 的有效长度)范围为20-300mm。有效长度是指在球囊扩张后，能贴附在血管内壁上的长度。药物涂层球囊100的直径、有效长度等尺寸规格可根据需要扩张的病变部位血管直径进行选择。
如图1及2所示，药物涂层球囊100包括球囊本体20和覆盖在球囊本体20外表面的药物涂层30。可以理解的，在一实施例中，药物涂层30覆盖整体球囊本体20的外表面。在另一实施例中，药物涂层30可部分覆盖球囊本体20的外表面。
球囊本体20为可扩张球囊。具体的，在本实施例中，球囊本体20可选择性地充气液或放液，从而可改善药物涂层球囊100的贴壁性。在本实施例中，药物涂层30设置在球囊本体20对应工作段11的位置。
可以理解的，在一实施例中，活性药物涂层30中包含有活性药物。可选的，在另一可选实施例中，活性药物层30中还包括载体。载体可用于促进活性药物从球囊本体20的外表面快速释放或促进病变组织的吸收。载体例如是，但不局限于有机酸盐或多元醇，本实施例中采用甘露醇作为载体。在本实施例中，活性药物为具备抑制平滑肌细胞增生作用的药物(如：紫杉醇、雷帕霉素等)，本实施例中采用紫杉醇。活性药物涂层30主要通过涂覆方式形成在球囊本体20上，且涂覆方式为现有的常规涂覆技术，在此不再赘述。药物涂层球囊100的圆柱形的工作段11可以保证充盈后的药物涂层球囊100具有良好贴壁性，能有效地将活性药物转移到病变部位的血管内壁上。
请一并参阅图2和图3，在本实施例中，推送导管310沿轴向穿过药物涂层球囊100的两端，并且与药物涂层球囊100密封连接。推送导管310具有收容在球囊本体20内的第一部分311和裸露在球囊本体20外的第二部分312。推送导管310的内部沿轴向设置导丝腔1及第一充盈腔2。导丝腔1与第一充盈腔2隔离且并排设置。导丝腔1用于容纳并通过导丝。第一充盈腔2用于向药物涂层球囊100内通入或抽出液体使球囊本体20充盈或者泄压。导丝腔1轴向贯穿推送导管310的远端和近端。第一充盈腔2与药物涂层球囊100的球囊本体20连通。可以理解的，在其他实施例中，用户可以根据病变组织实际状态及充盈所需时间在推送导管310的内部设置一个或多个导丝腔1及第一充盈腔2。
请再次参见图1和图3，推送装置300还包括设于推送导管310近端的导管座320。导管座320设有导丝端口15及第一充盈端口16。导丝端口15与导丝腔1连通。导丝腔1及导丝端口15用于容纳并通过导丝。推送导管310的第一部分311开设有与第一充盈腔2相贯通的球囊充盈口101。第一充盈腔2与第一充盈端口16及球囊充盈口101相连通。在本 实施例中，第一充盈腔2的相对两端分别与第一充盈端口16及球囊充盈口101相连通。由此，第一充盈端口16、第一充盈腔2和球囊充盈口101形成对药物涂层球囊100进行充盈或者泄压的通道。通过第一充盈端口16连接外部压力泵，压力液体经由第一充盈端口16、第一充盈腔2及球囊充盈口101进入或者流出药物涂层球囊100内部，以实现药物涂层球囊100的充盈膨胀或泄压。
推送导管310的第一部分311还设置有显影定位装置111。显影定位装置111由不透射线的材料制成，且用于手术过程中药物涂层球囊100的定位。显影定位装置111优选设置在与药物涂层球囊100的工作段11对应的推送导管310上，也即设置在推送导管310的第一部分311。显影定位装置111可以采用环状、丝状、带状或者点状等多种形式，并且通过压握、热熔、粘接、焊接或者压铆等本领域常用的技术手段固定在推送导管310上。
请参见图1、图4a至图4b，护套220活动地套设在推送导管310上，且收容药物涂层球囊100，以对药物涂层球囊100外表面的活性药物涂层30进行保护。护套220可沿推送导管310的轴向运动。药物涂层球囊100在扩张前收容于护套220内。护套220优选为管状结构，可以套设在折翼并卷绕后的药物涂层球囊100外部。优选地，护套220内径比在扩张前的折翼并卷绕后的药物涂层球囊100的最大外径大0～0.10mm。为了利于护套220沿着推送导管310的轴向滑动，护套220优选采用e-PTFE、PTFE、FEP或PET等摩擦系数较小的材料制成。
请同时参见图4a、图4b、图5及图6，护套220靠近推送导管310的远端设置有收缩罩210。收缩罩210大致呈圆台状。收缩罩210的直径朝远离推送导管310的远端的方向逐渐减小，即，收缩罩210朝远端逐渐收拢并收容推送导管310的远端。收缩罩210可覆盖在护套220的远端部或者与护套220的远端相连。收缩罩210沿轴向开设有至少一个伸缩缝211。当伸缩缝211张开时，药物涂层球囊100从护套220靠近远端的一侧伸出并裸露于护套220的外圈。
可选的，伸缩缝211的最小直径小于药物涂层球囊100的最大直径。可以理解的，伸缩缝211优选设置为可撕裂的结构，也即收缩罩210的伸缩缝211未贯穿收缩罩210的外侧壁。具体的，在伸缩缝211未张开前，伸缩缝211两侧的收缩罩210至少部分相连，此时，收缩罩210的远端仅供推送导管310的远端穿出，而药物涂层球囊100无法伸出。由此，在药物涂层球囊100的输送过程中，护套220可保护药物涂层球囊100外表面的药物涂层30，减少血管内血液对其的冲刷导致的药物损失。当药物涂层球囊100输送至病变部 位后，回撤护套220(也即护套220相对推送导管310朝近端方向移动)，伸缩罩210被药物涂层球囊100撑开直至撕裂，收缩罩210的远端开口直径增大，使得收纳于护套220中的药物涂层球囊100可以自护套220的远端及收缩罩210的远端伸出并暴露于病变部位的血管环境中，然后再对药物涂层球囊100进行充盈扩张，活性药物涂层30自球囊本体20外表面释放并转移至病变部位的血管内壁。伸缩罩210的材料与护套220的材料可以相同也可以不相同，为了简化生产工艺，优选为采用相同材料一体成型。
请同时参见图1、图4a、及图4b，护套220的近端还设置有活动地套设于推送导管310操作手柄230。操作手柄230用于控制护套220沿推送导管310的轴向滑动。护套220与操作手柄230相连接。如图4a所示，在一实施例中，护套220的近端可与操作手柄230直接连接。如图4b所示，在另一实施例中，护套220的近端也可以通过中空管体240与操作手柄230间接相连，且中空管体240活动地套装在推送导管310的外部。在药物涂层球囊100的输送过程中，药物涂层球囊100收容在护套220内，保护药物涂层30不受血液冲刷。当到达病变部位后，向近端后撤操作手柄230，使得护套220沿轴向朝近端的方向滑动，此时位于护套220远端的收缩罩210张开，药物涂层球囊100从收缩罩210中露出。
可以理解的是，在其他实施例中，药物涂层球囊100的数量还可以为多个，以便对多个病变部位同时扩张。具体地，请参见图7，为本申请第二实施例提供的药物涂层球囊导管。在第二实施例中，药物涂层球囊导管2000的结构与第一实施例的药物涂层球囊导管1000的结构相似，因此药物涂层球囊导管2000包含的各元件尺寸、元件名称、各元件位置关系等均可参考药物涂层球囊导管1000，在此不再赘述。不同的是，药物涂层球囊导管2000包括固定地设置在推送导管310的远端的两个药物涂层球囊100，导管座320设有第一充盈端口16及第二充盈端口16’，以及推送导管310的内部沿轴向设置第一充盈腔2和第二充盈腔2’。
具体的，在本实施例中，推送装置300包括一根推送导管310。两个药物涂层球囊100包括第一药物涂层球囊110及第二药物涂层球囊120。推送导管310依次贯穿第二药物涂层球囊120及第一药物涂层球囊110，并与第一药物涂层球囊110及第二药物涂层球囊120密封连接。第一药物涂层球囊110与第二药物涂层球囊120串联且间隔设置。
可以理解的，在其他实施例中，第一药物涂层球囊110及第二药物涂层球囊120之间的相互位置不作限定，只需二者均位于推送导管310远端即可。具体的，第一药物涂层球囊110及第二药物涂层球囊120之间的轴向距离可以为零，也可以根据病变部位的间距， 间隔一定距离设置。
请参见图8至图10，推送导管310内沿轴向分别设有用于容纳并通过导丝的一个导丝腔1、第一充盈腔2和第二充盈腔2’。第一充盈腔2和第二充盈腔2’分别与对应的第一药物涂层球囊110和第二药物涂层球囊120的内腔相连通。导丝腔1、第一充盈腔2和第二充盈腔2’的腔体之间隔离设置。推送导管310可以采用一体成型的多腔管(如图8及图9所示)或者将多根管体组装在一起(如图10所示)。
图8及图9中，采用一体成型的多腔管作为推送导管310。推送导管310内设有相互隔开的导丝腔1、第一充盈腔2和第二充盈腔2’。多腔管的横截面形状不作限定，只需三个功能腔体相互平行、互不连通即可。导丝腔1用于穿装导丝，因此，导丝腔1需要腔体光滑且形状利于导丝移动，通常导丝腔1的横截面选用圆形或椭圆形等形状。第一充盈腔2和第二充盈腔2’的横截面形状不作限定，可以是任何形状，一般会根据推送导管310的横截面形状及导丝腔1位置和形状，排布具备最大横截面积的第一充盈腔2和第二充盈腔2’以利于药物涂层球囊的快速充盈或者泄压。
图10中，两根管体组装在一起形成推送导管310。推送导管310包括外管31a和内管31b，二者套装并固定在一起形成推送导管310。内管31a的管腔作为导丝腔1。内管31a与外管31b之间的空间以及外管31b内设置的一个管腔分别作为第一充盈腔2和第二充盈腔2’。可以理解的是，在其他实施方式中，推送导管310还可以采用多根管体套装在一起形成推送导管310。
第一药物涂层球囊110及第二药物涂层球囊120的形状及直径可以相同，也可以不同。第一药物涂层球囊110及第二药物涂层球囊120的形状通常为圆柱形或球形，直径根据血管直径选择。可以理解的是，两个药物涂层球囊的设置不仅可以针对不同病灶同时进行处理，同时，在其中一个药物涂层球囊被充盈后，该药物涂层球囊还可以具有阻断血流的作用，避免另外一个药物涂层球囊表面的药物涂层被血流冲刷。在这种情况下，先充盈的球囊上可以不设置活性药物涂层，以降低器械的成本。
请再次参见图7，推送导管310的近端设有导管座320。导管座320设有导丝端口15、第一充盈端口16和第二充盈端口16’。导丝端口15与导丝腔1相连通。由此，导丝可活动地穿设于导丝端口15及导丝腔1形成的通道中。推送导管310包括分别对应封装于第一药物涂层球囊110与第二药物涂层球囊120内的两第一部分311和裸露设置在第一药物涂层球囊110与第二药物涂层球囊120外部的第二部分312。
推送导管310的两第一部分311分别对应开设第一球囊充盈口101和第二球囊充盈口101’。第一充盈腔2的近端及远端分别与第一充盈端口16和第一球囊充盈口101相连通。第二充盈腔2’的近端及远端分别与第二充盈端口16’和第二球囊充盈口101’相连通。由此，第一充盈端口16、第一充盈腔2及第二球囊充盈口101形成对第一药物涂层球囊110进行充盈或泄压的通道。第二充盈端口16’、第二充盈腔2’和第二球囊充盈口101’形成对第二药物涂层球囊120进行充盈或泄压的通道。
推送导管310在与第一药物涂层球囊110及第二药物涂层球囊120的工作段11对应的两第一部分311上分别设有至少一个显影定位装置111，以便于在仪器检测下通过显示显影定位装置111的位置以指示球囊位置。显影定位装置111可以采用不透射线的显影材料制成，并具有环状物、丝状、带状、点状或者片状等结构形式。显影定位装置111优选采用显影环的形式。显影定位装置111可分别设置一个或多个。显影定位装置111的固定方式可以为焊接、粘接、热压、压铆等本领域通用技术手段，在此不再赘述。
本实施例提供的药物涂层球囊导管，与现有技术相比，至少具有以下优点：
(1)可滑动的护套对球囊表面的药物涂层具有保护作用，可降低输送过程中的药物损失率；
(2)可避免脱落的药物被血液冲刷至远端血管，堵塞血管；
(3)由于降低了药物损失率，也可降低药物球囊表面的初始载药量，减轻机体的代谢负担，提高了药物涂层球囊导管的安全性。
请参阅图11，为本发明第三实施例提供的一种药物涂层球囊导管。在第三实施例中，药物涂层球囊导管3000的结构与第二实施例的药物涂层球囊导管2000的结构相似，因此药物涂层球囊导管3000包含的各元件尺寸、元件名称、各元件位置关系等均可参考药物涂层球囊导管2000，在此不再赘述。不同的是，药物涂层球囊导管3000还包括相对推动导管310滑动的滑动导管340和连接推动导管310和滑动导管340的锁定机构500，第一药物涂层球囊110固定地设置在推送导管310，第二药物涂层球囊120固定地设置在滑动导管340。
第一药物涂层球囊110和第二药物涂层球囊120之间的距离可以调节。
具体地，请参见图11，推送装置300包括推送导管310及活动地套设于推送导管310的外部且可以沿轴向与推送导管310相对运动的滑动导管340。推送导管310的远端固定设置至少一个第一药物涂层球囊110。滑动导管340的远端设有至少一个第二药物涂层球囊 120。第一药物涂层球囊110和第二药物涂层球囊120之间的距离可以调节。可以理解的是，在其他实施例中，滑动导管340的数量可以根据实际情况设定，一般优选设置1-2个，相应地，每根滑动导管340远端的第二药物涂层球囊120的数量也可以设置为一个或者多个，一般优选设置1-2个。在本实施例中，推送导管310的远端与滑动导管340的远端同轴设置，也即第一药物涂层球囊110和第二药物涂层球囊120同轴设置。在其他实施例中，推送导管310的远端与滑动导管340的远端也可平行设置。可选的，第一药物涂层球囊110和第二药物涂层球囊120间隔错开设置。
护套220活动地套设于第一药物涂层球囊110与第二药物涂层球囊120的外部，即，第一药物涂层球囊110与第二药物涂层球囊120在扩张前均收容于护套220内。护套220的远端设有收缩罩210。收缩罩210上设置至少一条伸缩缝(图未示)。护套220的结构与实施例一的护套220的结构基本相同，在此不再赘述。
请一并参见图11和图12，推送导管310的内部沿轴向分别设置有互不连通的导丝腔1及用于对第一药物涂层球囊110进行充盈或泄压的第一充盈腔2。推送导管310的近端设有导管座320。导管座320设有第一充盈端口16。推送导管310的第一部分311开设有第一球囊充盈口101。第一充盈腔2的近端及远端分别与第一充盈端口16和第一球囊充盈口101相连通。由此，第一球囊充盈口101、第一充盈腔2及第一充盈端口16形成对第二药物涂层球囊120进行充盈及泄压的通道。
滑动导管340的内部沿轴向设有用于对第二药物涂层球囊120进行充盈或泄压的第二充盈腔4。第二充盈腔4与第二药物涂层球囊120的内腔相连通。滑动导管340的横截面形状与穿设其中的推送导管310有关，由于推送导管310占用较大空间，因此，第二充盈腔4设置在推送导管310的旁边空间。在滑动导管340近端设有调节手柄330。调节手柄330设有第二充盈端口17。滑动导管340包括封装在第二药物涂层球囊120内的第一部分341和裸露在第二药物涂层球囊120外部的第二部分342。滑动导管340的第一部分341开设有第二球囊充盈口103。第二充盈腔4的近端及远端分别与第二充盈端口17和第二球囊充盈口103相连通。由此，第二球囊充盈口103、第二充盈腔4及第二充盈端口17形成对第二药物涂层球囊120进行充盈及泄压的通道。
第二药物涂层球囊120焊接或粘接固定在滑动导管340上。第二药物涂层球囊120的结构和形状可以与第一药物涂层球囊110相同也可以不同。第二药物涂层球囊120可以是普通球囊，也可以是至少部分表面涂覆药物涂层的药物涂层球囊。第二药物涂层球囊120 除了可以对病变部位进行扩张之外，还可以作为封堵球囊，即，第二药物涂层球囊120先充盈并扩张后，封堵血管，避免第一药物涂层球囊110自护套220中伸出后活性药物涂层30被血液冲刷。可以理解的是，用于封堵血管的第二药物涂层球囊120的表面优选为不设置活性药物涂层。
第一药物涂层球囊110与第二药物涂层球囊120的尺寸根据要扩张的血管直径而定，具体不做限定。但是在第二药物涂层球囊120用于封堵血管时，第二药物涂层球囊120的直径应稍大于第一药物涂层球囊110的直径，使得第二药物涂层球囊120能在器械进入病变部位充盈后，比第一药物涂层球囊110先扩张，从而阻断血流，避免血流对第一药物涂层球囊110外表面的活性药物涂层30的冲刷。
由于滑动导管340与推送导管310同轴设置，即，管状结构的滑动导管340活动地套设在推送导管310外，可以减少球囊导管的整体外径，节省空间，利于推送，及提高通过性。
推送导管310与滑动导管340之间可以是间隙配合或滑动配合。为了降低二者之间的摩擦力，推送导管310外表面和/或滑动导管340内表面中的至少一个优选为利于滑动的光滑表面。该光滑表面可以是直接在表面上涂覆润滑涂层，例如在推送导管310外表面涂覆硅酮、聚乙烯吡络烷酮等润滑材料。该光滑表面也可以是采用摩擦系数低的材料制成推送导管310或/和滑动导管340。
请参见图13及图14，滑动导管340与推送导管310之间设有锁定机构500。当推送导管310及滑动导管340同时到达病变部位附近，通过向远端推送或向近端后撤滑动导管340，以调整第一药物涂层球囊110与第二药物涂层球囊120之间的距离后，可以通过锁定机构500将推送导管310和滑动导管340之间的相对位置固定，即可将第一药物涂层球囊110与第二药物涂层球囊120之间的相对位置固定。锁定机构500有多种实施方式，具体说明如下：
如图13所示，为锁定机构500的第一种实施方式：滑动导管340活动地套设在推送导管310外。在本实施例中，锁定机构500为固定在滑动导管340上的弹性锁定件。弹性锁定件旋转后抱紧推送导管310将滑动导管340和推送导管310锁定。弹性锁定件的具体结构为：弹性锁定件包括固定在滑动导管340上的定位管510及与定位管510螺纹连接的手轮530。定位管510套设并固定在滑动导管340的近端，且定位管510较调节手柄330更接近滑动导管340的近端。定位管510与推送导管310之间设有圆筒状、具有弹性的弹性 套520。在自由状态下，弹性套520与推送导管310之间可滑动配合或间隙配合。手轮530连接有插入定位管510中的顶压头540。通过旋转手轮530，可带动顶压头540向弹性套520的方向移动并压紧弹性套520，弹性套520受压后变形，径向伸展并且轴向收缩，抱紧推送导管310外表面，从而将滑动导管340与推送导管310锁定；通过反向旋转手轮530，顶压头540向远离弹性套520的方向移动，弹性套520不再受压，具有弹性的弹性套520恢复自由状态，解除滑动导管340与推送导管310之间的锁定。可以理解的是，在其他实施例中，弹性锁定件也可以固定在推送导管310上。弹性锁定件旋转后卡住滑动导管340将其与推送导管310锁定。
如图14所示，为锁定机构500的第二种实施方式：锁定机构500包括设置在推送导管310上的第一锁定件51及设置在滑动导管340上的第二锁定件52，且第一锁定件51与第二锁定件52之间可拆卸连接。在第一锁定件51与第二锁定件52处于分离状态时，推送导管310及滑动导管340之间可沿轴向相对运动，以调整第一药物涂层球囊110与第二药物涂层球囊120之间的距离。在第一锁定件51与第二锁定件52处于连接状态时，推送导管310及滑动导管340之间不可沿轴向相对运动，第一药物涂层球囊110与第二药物涂层球囊120之间的距离也被固定。优选地，第一锁定件51与第二锁定件52之间的可拆卸连接为螺纹连接或者卡合连接。以螺纹连接为例，请参见图14，第一锁定件51固定在推送导管310上，第一锁定件51设有外螺纹55。第二锁定件52限位固定在滑动导管340上，第二锁定件52设置内螺纹56。第一锁定件51与第二锁定件52之间通过螺纹可拆卸连接。第二锁定件52的限位固定是指第二锁定件52仅可在滑动导管340上原位转动，不能轴向移动。
图15至图19示出了采用本发明第三实施例提供的药物涂层球囊导管3000对血管病变部位进行治疗的过程，具体如下：
第一步：请参见图15，首先将药物涂层球囊导管的远端部分输送到血管900的病变位置附近，并将第一药物涂层球囊110对准第一病变部位；
第二步：请参见图16，向近端后撤护套220，收缩罩210上的伸缩缝211张开，第一药物涂层球囊110和第二药物涂层球囊120分别暴露在血管900中。
第三步：请参见图17，向近端后撤滑动导管340，使得第二药物涂层球囊120对准第二病变部位。
第四步：请参见图18，对第二药物涂层球囊120进行充盈，充盈后的第二药物涂层球 囊120对第二病变部位的血管充分扩张，同时会阻断血管的血液流动。
第五步：请参见图19，对第一药物涂层球囊110进行充盈，第一药物涂层球囊110充盈后对第一病变部位的血管充分扩张，药物涂层自第一药物涂层球囊110表面释放并转移至血管壁，发挥药效。之后即可分别对第一药物涂层球囊110及第二药物涂层球囊120进行泄压，撤出患者体外，完成手术。可以理解的是，第二步和第三步的顺序可以交换，只要将两个球囊分别自护套中露出即可。
本实施例提供的药物涂层球囊导管，与现有技术相比，至少具有以下优点：
(1)可滑动的护套对球囊表面的药物涂层具有保护作用，可降低输送过程中的药物损失率；
(2)药物涂层球囊与第二球囊之间的相对位置可以调节，可以更好地适应血管的多个病变部位；
(3)第二球囊可以作为封堵球囊，暂时阻断血管中的血液流动，进一步避免血液对药物涂层球囊表面的活性药物涂层的冲刷，降低药物损失率，提高药物自球囊表面转移至血管壁的药量及效率；
(4)在调节第二球囊的位置之后，可以通过锁定机构将第二球囊与药物涂层球囊导管之间的距离锁定，利于使用者进行后续操作。
请参见图20，为本发明第四实施例提供的药物涂层球囊导管。在第四实施例中，药物涂层球囊导管4000的结构与第三实施例的药物涂层球囊导管3000的结构相似，因此药物涂层球囊导管4000包含的各元件尺寸、元件名称、各元件位置关系等均可参考药物涂层球囊导管3000，在此不再赘述。不同的是，药物涂层球囊导管4000的推送导管310和滑动导管340之间的位置关系与实施例三的推送导管310和滑动导管340的位置关系不同。
具体地，如图20所示，药物涂层球囊导管4000的远端包括第一推送分支313和第二推送分支314。第一推送分支313设置在推送导管310的远端，第二推送分支314设置在滑动导管340的远端。
在本实施例中，第一推送分支313连接推送导管310设置有第一药物涂层球囊110的远端。第二推送分支314连接滑动导管340设置有第二药物涂层球囊120的远端。连接的方式可以是固定连接或一体成型。推送导管310的远端与滑动导管340的远端形成夹角α。具体的，第一推送分支313的轴向与第二推送分支的轴向之间的夹角α的范围为(0°，180°]，即夹角α为180°≥α＞0°。夹角α的角度设置是基于人体两条分支血管之间的夹角一般不大 于180°，以利于第一推送分支313和第二推送分支314分别将第一药物涂层球囊110及第二药物涂层球囊120送入分叉血管的两个分支血管。滑动导管340沿轴向相对推送导管310运动。由此，第一药物涂层球囊110和第二药物涂层球囊120之间的相对位置可以调节，使得球囊导管的使用过程更加灵活，可以在第二药物涂层球囊120进入分支后，根据第二药物涂层球囊120及病变部位的位置，再进行合理调整。
推送导管310与滑动导管340之间的位置关系有以下两种：滑动导管340可活动地穿设于推送导管310的内部，或者推送导管310与滑动导管340之间并列设置。
请参见图20，滑动导管340套设于推送导管310的外部即，推送导管310活动地穿设在滑动导管340的内部。滑动导管340的管体侧壁在第一推送分支313和第二推送分支314的交叉处开设有通孔318。推送导管310的远端从通孔318中穿出，且与第二推送分支314连接。由此，推送导管310与滑动导管340可在轴向上相对运动，带动第二推送分支314向远端或近端移动，来调整第二药物涂层球囊120的位置，以适应不同结构的分叉血管以及分叉血管不同的狭窄位置。可以理解的是，推送导管310与滑动导管340之间可以通过锁定机构进行锁定，锁定机构的具体结构与实施例二的锁定机构500的结构基本相同，在此不再赘述。
请一并参阅图21a和图21b，滑动导管340还可以与推送导管310并列设置，二者之间通过限位件350连接，使得二者之间仅沿轴向相互运动。限位件350有多种方式：例如，推送导管310与滑动导管340可以穿装在环状箍中，以限制二者之间的径向移动。再例如，推送导管310与滑动导管340可以共同套装在具有一定长度的限位管中，限制二者之间的径向移动。为了减少球囊导管整体直径、增强推送力、提高安全性，推送导管310与滑动导管340的形状应相互配合形成完整的、无棱角的形状，例如圆形或椭圆形。
如图21a所示，是推送导管310沿XXI-XXI方向的剖视图，滑动导管340的内部沿轴向设置至少一个第二充盈腔4，第二充盈腔4的远端与所述第二药物涂层球囊120的内部连通。
推送导管310内沿轴向设置有延伸至第一推送分支313远端的导丝腔1，及用于第一药物涂层球囊110充盈及泄压的第一充盈腔2。第一充盈腔2延伸至第一推送分支313的第一药物涂层球囊110处。滑动导管340的内部还沿轴向设置有第二导丝腔3、及用于第二药物涂层球囊120充盈及泄压的第二充盈腔4。第二导丝腔3延伸至第二推送分支314远端，第二充盈腔4延伸至第二推送分支314的第二药物涂层球囊120处。第二导丝腔3和第二 充盈腔4隔离设置。第一充盈腔2从推送导管310内沿轴向与位于第一推送分支313远端的第一药物涂层球囊110内腔相连通。第二充盈腔4从滑动导管340内沿轴向与位于第二推送分支314远端的第二药物涂层球囊120内腔相连通。
在一实施例中，药物涂层球囊导管4000包括一个护套220。具体的，推送导管310的外部套设有一个护套220。第一药物涂层球囊110和第二药物涂层球囊120未扩张时，二者同时收卷容置在护套220中，即护套220同时将第一药物涂层球囊110和第二药物涂层球囊120一起保护。
在另一实施例中，如图22所示，药物涂层球囊导管5000包括第一护套220和第二护套240。第一药物涂层球囊110收容于第一护套220内，第二药物涂层球囊120所述第二护套240收容于第二护套240内。第一护套220活动地设置在推动导管310上，且套设于第一药物涂层110的外部。第二护套240活动地设置在滑动导管340上，且套设于第二药物涂层球囊120的外部，且第二护套240沿滑动导管310的轴向运动。第一药物涂层球囊110在扩张前收容于第一护套220内，第二药物涂层球囊120在扩张前收容于第二护套240内。第一护套220与第二护套240各自独立设置，其中第一护套220套装在推送导管310和第一药物涂层球囊110的外部。第二护套240套装在滑动导管340和第二药物涂层球囊120的外部。第二护套240和滑动导管340都套装在推送导管310内。第二护套240近端连接有手柄260，用于操作第二护套240后撤。在器械到达分叉血管后，将第一药物涂层球囊110送入第一分支血管，并通过移动滑动导管340将第二药物涂层球囊120送入第二分支血管，然后分别后撤护套220及第二护套240，第一药物涂层球囊110和第二药物涂层球囊120分别暴露在血管环境中，然后对第一药物涂层球囊110和第二药物涂层球囊120分别充盈扩张，治疗第一分支血管及第二分支血管。第一护套220及第二护套240的其余结构与实施例一的护套220的结构基本相同，在此不再赘述。
第一药物涂层球囊110与第二药物涂层球囊120的尺寸规格根据要扩张的血管直径而定，具体不做限定。第一药物涂层球囊110和第二药物涂层球囊120的数量分别是至少一个。当第一药物涂层球囊110和第二药物涂层球囊120各设置一个时，第一药物涂层球囊110和第二药物涂层球囊120分别对应设置在第一推送分支313和第二推送分支314的远端。当第一药物涂层球囊110和第二药物涂层球囊120设置多个时，则相邻两第一药物涂层球囊110之间和每个相邻两第二药物涂层球囊120之间可以紧邻或者间隔设置。推送导管310及滑动导管340分别对应设置有用于对各第一药物涂层球囊110及各第二药物涂层 球囊120充盈及泄压的第三充盈腔和第四充盈腔(图未示)。
如图23-25所示，第一药物涂层球囊110和/或第二药物涂层球囊120的工作段115的近端直径大于该球囊的工作段115的外圈部分的直径。第一药物涂层球囊110和/或第二药物涂层球囊120的工作段115是指：在血管内与血管内壁贴合用于扩张血管的部分。这样设置的原因是，当第一药物涂层球囊110及第二药物涂层球囊120分别被推送至分叉血管的两个分支血管中后，第一药物涂层球囊110及第二药物涂层球囊120的工作段115近端同时位于分叉血管的分叉位置，且该分叉位置的血管直径必然小于两个分支血管直径之和。故，为了避免位于分叉位置的第一药物涂层球囊110的工作段115近端与第二药物涂层球囊120的工作段115的近端同时充盈后导致分叉位置的血管撕裂，第一药物涂层球囊110工作段115的近端和第二药物涂层球囊120工作段115近端直径之和需小于第一药物涂层球囊110和第二药物涂层球囊120工作段115其余部分直径之和。
同时，对于球囊来讲，工作段115的长度即为球囊的有效长度，决定了球囊对血管的扩张治疗性能。本实施例的第二药物涂层球囊120的工作段115的近端直径小于该球囊的工作段115的其余部分直径，但是与普通的锥形球囊相比，第二药物涂层球囊120仍然具有较长的有效长度，因此在充盈后，对分支血管的血管壁的扩张能力较高。除了第二药物涂层球囊120的工作段的近端直径小于第二药物涂层球囊120的工作段115的外围部分直径外，还可以是第一药物涂层球囊110的工作段的近端直径小于第一药物涂层球囊110的工作段115的外围部分直径，或者第一药物涂层球囊110的工作段的近端直径小于第一药物涂层球囊110的工作段的其余部分直径，且第二药物涂层球囊120的工作段的近端直径都分别小于第二药物涂层球囊120的工作段的其余部分直径。
第一药物涂层球囊110靠近近端的部分或/和第二药物涂层球囊120靠近近端的部分的直径由远端至近端逐渐减小。由此，当第一药物涂层球囊110和第二药物涂层球囊120同时充盈后，可进一步防止分叉位置的血管撕裂。
请参见图23，第一药物涂层球囊110的近端部及远端部均为锥形结构116、中部为圆柱形的工作段115。第二药物涂层球囊120大致呈锥形，即第二药物涂层球囊120的近端直径小，第二药物涂层球囊120的远端直径大的锥形。请参见图24，第二药物涂层球囊120的近端123和远端121均为锥形结构，第二药物涂层球囊120的中部122为圆柱形结构，圆柱形结构与锥形结构之间平滑过渡。
请参见图25，第二药物涂层球囊120的近端123和远端121大致为锥形结构，第二药 物涂层球囊120的中部122大致为圆柱形结构，圆柱形结构的直径与锥形结构的直径不同而形成阶梯结构。第二药物涂层球囊120的近端121的锥形结构一般为长锥形结构，即锥度变化小，形成一段长度较长、直径变化小的锥形，且该部分锥形直径相对于圆柱形部分要小很多。锥形、长锥形结构能加大第一药物涂层球囊110和第二药物涂层球囊120之间的间距，避免充盈后二者贴合或间距小造成，血管扩张过渡、血管撕裂或形成夹层。
第二药物涂层球囊120的表面涂覆也可以设有活性药物涂层。活性药物涂层主要设置在圆柱形工作段115的外表面。第二药物涂层球囊120也可以不设置活性药物涂层。
本实施例的药物涂层球囊导管，与现有技术相比，至少具有以下优点：
(1)可滑动的护套对球囊表面的药物涂层具有保护作用，可降低输送过程中的药物损失率；
(2)药物涂层球囊与第二球囊之间的相对位置可以调节，可以更好地适应分叉血管的多个分支血管以及不同病变位置；
(3)第二球囊可以设置为不规则形状，避免撕裂分叉位置的血管；
(4)在调节第二球囊的位置之后，可以通过锁定机构将第二球囊与药物涂层球囊导管之间的相对位置锁定，利于使用者进行下一步操作。
综上，本发明的药物涂层球囊导管，通过在药物涂层球囊的外部设置可滑动的护套，避免了血流对药物涂层的冲刷，从而有效地降低输送过程中的药物损失率，提高药物涂层球囊的有效性；同时可避免脱落的药物被血液冲刷至远端血管，堵塞血管；此外，由于降低了药物损失率，也可降低药物球囊表面的初始载药量，减轻机体的代谢负担，提高了药物涂层球囊的安全性。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。

Claims (22)

  1. 一种药物涂层球囊导管，包括：
    推送导管，具有相对的近端和远端；
    至少一第一药物涂层球囊，固定地设置在所述推送导管的远端；及
    护套，所述护套相对所述推送导管可活动，以使各所述第一药物涂层球囊收容在所述护套内或裸露在所述护套外。
  2. 根据权利要求1所述的药物涂层球囊导管，其特征在于，各所述第一药物涂层球囊在扩张前收容在所述护套内，当所述护套朝所述推送导管的近端活动时，各所述第一药物涂层球囊裸露在所述护套外。
  3. 根据权利要求1所述的药物涂层球囊导管，其特征在于，所述护套的远端设置有收缩罩，所述收缩罩的远端逐渐收拢并收容所述推送导管的远端。
  4. 根据权利要求3所述的药物涂层球囊导管，其特征在于，所述收缩罩沿轴向开设有至少一个伸缩缝。
  5. 根据权利要求3所述的药物涂层球囊导管，其特征在于，所述收缩罩的最小直径小于所述第一药物涂层球囊在扩张前的最大直径。
  6. 根据权利要求1所述的药物涂层球囊导管，其特征在于，所述护套的内径比各所述第一药物涂层球囊在扩张前的最大外径大0～0.10mm。
  7. 根据权利要求1所述的药物涂层球囊导管，其特征在于，所述推送导管的内部沿轴向设置至少一个导丝腔及至少一个第一充盈腔，各所述导丝腔贯穿所述推送导管的近端及远端，各所述第一充盈腔与对应的所述第一药物涂层球囊的内部连通。
  8. 根据权利要求7所述的药物涂层球囊导管，其特征在于，所述药物涂层球囊导管还包括设置于所述推送导管的近端的导管座，所述导管座设置有导丝端口及至少一个第一充盈端口，所述导丝端口与对应的所述导丝腔相连通，各所述第一充盈端口与对应的所述第一充盈腔相连通。
  9. 根据权利要求1所述的药物涂层球囊导管，其特征在于，每一所述第一药物涂层球囊导管还包括操作手柄，所述操作手柄与所述护套连接，且活动地套设在所述推送导管上。
  10. 根据权利要求1所述的药物涂层球囊导管，其特征在于，所述药物涂层球囊导管还包括具有远端的滑动导管和固定设置在所述滑动导管的远端的第二药物涂层球囊，所述 滑动导管相对所述推送导管可活动，以调节所述第一药物球囊和所述第二药物球囊之间的距离。
  11. 根据权利要求10所述的药物涂层球囊导管，其特征在于，所述推送导管的远端和所述滑动导管的远端平行或同轴设置或是所述推送导管的远端与所述滑动导管的远端之间存在夹角。
  12. 根据权利要求10所述的药物涂层球囊导管，其特征在于，所述滑动导管的内部沿轴向设置有第二充盈腔，所述第二充盈腔与所述第二药物涂层球囊的内部连通。
  13. 根据权利要求10所述的药物涂层球囊导管，其特征在于，所述第二药物涂层球囊在扩张前收容于所述护套内，当所述护套朝所述滑动导管的近端活动时，所述第二药物涂层球囊裸露在所述护套外。
  14. 根据权利要求13所述的药物涂层球囊导管，其特征在于，所述护套包括第一护套和第二护套，所述第一药物涂层球囊收容于所述第一护套内，所述第二药物涂层球囊收容于所述第二护套内。
  15. 根据权利要求14所述的药物涂层球囊导管，其特征在于，所述第一护套和所述第二护套同轴设置，且所述第一护套相对所述推动导管可活动，所述第二护套相对所述滑动导管可活动。
  16. 根据权利要求14所述的药物涂层球囊导管，其特征在于，所述第一药物涂层球囊与所述第二药物涂层球囊间隔设置。
  17. 根据权利要求14所述的药物涂层球囊导管，其特征在于，所述第一药物涂层球囊及所述第二药物涂层球囊的外表面部分或全部涂覆药物涂层。
  18. 根据权利要求9所述的药物涂层球囊导管，其特征在于，所述滑动导管与所述推送导管的设置方式包括所述滑动导管活动地套设在所述推送导管的外部、所述滑动导管活动地穿设于所述推送导管的内部、或是所述滑动导管与所述推送导管并行排列设置。
  19. 根据权利要求18所述的药物涂层球囊导管，其特征在于，所述药物涂层球囊扩张导管还包括连接所述滑动导管与所述推送导管的锁定机构。
  20. 根据权利要求19所述的药物涂层球囊导管，其特征在于，所述锁定机构设置于所述滑动导管与所述推送导管之间。
  21. 根据权利要求19所述的药物涂层球囊导管，其特征在于，所述锁定机构为固定在所述滑动导管上的弹性锁定件，所述弹性锁定件旋转后抱紧所述推送导管将二者锁定；
    或者所述锁定机构为固定在所述推送导管上的弹性锁定件，所述弹性锁定件旋转后卡住所述滑动导管将二者锁定。
  22. 根据权利要求19所述的药物涂层球囊导管，其特征在于，所述锁定机构包括设置在所述推送导管上的第一锁定件及设置在所述滑动导管上的第二锁定件，所述第一锁定件与所述第二锁定件之间可拆卸连接，所述第一锁定件与所述第二锁定件连接时，所述推送导管与所述滑动导管之间固定，所述第一锁定件与所述第二锁定件之间拆卸无连接时，所述推送导管与所述滑动导管之间沿轴向相对运动。
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