WO2019024765A1 - 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
WO2019024765A1
WO2019024765A1 PCT/CN2018/097274 CN2018097274W WO2019024765A1 WO 2019024765 A1 WO2019024765 A1 WO 2019024765A1 CN 2018097274 W CN2018097274 W CN 2018097274W WO 2019024765 A1 WO2019024765 A1 WO 2019024765A1
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WO
WIPO (PCT)
Prior art keywords
balloon
catheter
drug
expansion
expansion sleeve
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2018/097274
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English (en)
French (fr)
Inventor
张庭超
李敬
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hangzhou Endonom Medtech Co Ltd
Original Assignee
Hangzhou Endonom Medtech Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hangzhou Endonom Medtech Co Ltd filed Critical Hangzhou Endonom Medtech Co Ltd
Priority to EP18840539.3A priority Critical patent/EP3662964A4/en
Publication of WO2019024765A1 publication Critical patent/WO2019024765A1/zh
Priority to US16/749,278 priority patent/US11617867B2/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A61M2025/1004—Balloons with folds, e.g. folded or multifolded
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • A61M2025/1015—Multiple balloon catheters having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1061—Balloon catheters with special features or adapted for special applications having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1081—Balloon catheters with special features or adapted for special applications having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/0032—Multi-lumen catheters with stationary elements characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts

Definitions

  • the invention belongs to the technical field of medical instruments and relates to a drug-coated balloon catheter.
  • pre-expand the lesion Before using the drug-coated balloon to expand the lesion, it is necessary to pre-expand the lesion with a common drug-free balloon, so that the drug-coated balloon can smoothly enter the lesion and avoid the blood vessel caused by one-time overexpansion. damage.
  • pre-expansion requires the use of an additional normal balloon, which increases the complexity of the procedure, and after pre-expansion, the high-flowing blood of the drug-coated balloon during delivery can result in a loss of drug volume.
  • the present invention provides a drug-coated balloon catheter which is simple in operation and high in drug utilization.
  • the present invention provides a drug coated balloon catheter comprising:
  • Pre-expansion agencies including:
  • An expansion sleeve for receiving the first balloon before and during the first expansion of the first balloon
  • a connector coupled to the expansion sleeve and axially movable relative to the push catheter after the first balloon is pre-expanded to expose the first balloon outside the expansion sleeve.
  • the pre-expansion mechanism is transported together with the drug-coated balloon to the patient, and the pre-expansion mechanism realizes pre-expansion of the lesion, so that the drug-coated balloon can smoothly enter the lesion, and the inner wall of the blood vessel of the lesion can be coated with the drug.
  • the area of contact with the surface of the layer balloon increases the amount of drug-coated balloon that is transferred to the vessel wall after expansion, thereby improving the therapeutic effect;
  • the pre-expansion mechanism is sleeved outside the drug-coated balloon, and is transported to the lesion site together with the drug-coated balloon during use, thereby effectively protecting the drug-coated balloon from blood flow and reducing the transportation process.
  • Drug loss
  • 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 cross-sectional view of the pusher catheter of the drug-coated balloon catheter of Figure 1 taken along line II-II;
  • Figure 3 is a schematic view of the drug-coated balloon catheter of Figure 1 prior to pre-expansion of the balloon;
  • Figure 4 is a cross-sectional view of the drug-coated balloon catheter of Figure 3 taken along line IV-IV;
  • Figure 5 is a schematic view of the drug-coated balloon catheter of Figure 1 after pre-expansion of the balloon;
  • Figure 6 is a cross-sectional view of the drug-coated balloon catheter of Figure 5 taken along line VI-VI;
  • Figure 7 is a schematic view of the drug-coated balloon catheter of Figure 1 after the expansion sleeve is moved away from the side of the balloon;
  • Figure 8 is a cross-sectional view of the drug-coated balloon catheter of Figure 7 taken along line VIII-VIII;
  • Figure 9 is a schematic view showing the structure of the balloon of the drug-coated balloon catheter of Figure 1 re-expanded after pre-expansion;
  • FIG. 10 is a schematic structural view of a drug-coated balloon catheter provided by a second embodiment of the present invention.
  • Figure 11 is a schematic view showing the structure of the first embodiment of the pusher catheter of the drug-coated balloon catheter of Figure 10;
  • Figure 12 is a schematic view showing the structure of a second embodiment of the pusher catheter of the drug-coated balloon catheter of Figure 10;
  • FIG. 13 is a schematic structural view of a drug-coated balloon catheter according to a third embodiment of the present invention.
  • Figure 14 is a cross-sectional view of the drug coated balloon catheter of Figure 13 taken along the line XIV-XIV.
  • FIG. 15 is a schematic structural view of a drug-coated balloon catheter according to a fourth embodiment of the present invention.
  • Figure 16 is a cross-sectional view of the drug coated balloon catheter of Figure 15 taken along the line XVI-XVI.
  • 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 distal end refers to one end of the instrument that can be freely inserted into an animal or a human body.
  • the near end refers to the end for user or machine operation or the end for connecting other devices.
  • 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 expandable first balloon at a distal end of the push catheter, and a pre-expansion mechanism. At least a portion of the surface of the first balloon is covered with a drug coating.
  • the pre-expansion mechanism includes an expandable expansion sleeve that is movably sleeved outside the first balloon, and a connector that is coupled to the proximal end of the expansion sleeve. The connector moves axially relative to the pusher catheter.
  • the drug coated balloon catheter 1000 includes a push catheter 310, a balloon 100 disposed on the push catheter 310, and a pre-expansion mechanism 200.
  • the push catheter 310 has opposing insertion ends (ie, distal ends) and an operating end (ie, proximal ends).
  • the balloon 100 is located at the distal end of the push catheter 310.
  • the outer surface of the balloon 100 is at least partially coated with a layer of drug coating 30.
  • the balloon 100 has a plurality of flaps prior to expansion. Alternatively, the balloon 100 has three to six flaps prior to expansion.
  • the balloon 100 is secured to the distal end of the push catheter 310.
  • the fixing method is a general technical means in the field of welding, bonding or fixing by a fixing member, and details are not described herein again.
  • the balloon 100 is composed of a proximal end portion, a distal end portion, and a working portion therebetween.
  • the proximal end portion and the distal end portion of the balloon 100 are substantially tapered, and the working portion of the balloon 100 is substantially cylindrical.
  • the working portion is located in the middle of the balloon 100.
  • the working part has a diameter of about 2-15 mm.
  • the balloon 100 has a length of approximately 30-320 mm.
  • the effective length of the balloon 100 (i.e., the length of the working portion) is approximately 20-300 mm.
  • the size, length, and effective length of the balloon 100 are selected according to the diameter of the diseased vessel to be treated.
  • the drug coating 30 is primarily disposed at the working portion of the balloon 100.
  • the drug coating 30 contains an active drug having an action of inhibiting smooth muscle cell proliferation, such as paclitaxel or rapamycin.
  • the drug coating 30 further contains a polyol, an organic acid salt or the like as a carrier. In the present embodiment, paclitaxel is used as an active drug and mannitol is used as a carrier.
  • the coating of the drug coating 30 is prior art and will not be described herein.
  • the working portion of the balloon 100 is cylindrical, so that the filled balloon 100 has good adherence and can be attached to the inner wall of the blood vessel with a certain length, and can effectively transfer the active drug to the blood vessel wall
  • the push catheter 310 is axially passed through both ends of the balloon 100 and is sealingly coupled to the balloon 100.
  • the push catheter 310 has a first portion 311 housed within the balloon 100 and a second portion 312 that is exposed outside of the balloon 100.
  • the pusher catheter 310 is axially provided with a guide wire lumen 1 and a filling chamber 2 provided in isolation from the guidewire lumen 1.
  • the guide wire cavity 1 and the cavity of the filling chamber 2 are not in communication with each other.
  • the guidewire lumen 1 extends through the push catheter 310 and is in communication with the balloon 100.
  • the guide wire lumen 1 is for wearing a guide wire (not shown).
  • the number of filling chambers 2 is one, and the distal end of the filling chamber 2 is in communication with the interior of the balloon 100 for filling and relieving pressure of the balloon 100. It can be understood that in another embodiment, in order to increase the filling and pressure relief speed of the balloon 100, the number of the filling chambers 2 may be plural, and each of the filling chambers 2 is in communication with the inner cavity of the balloon 100. Thereby, the amount of liquid flowing into/out of the balloon 100 per unit time is increased, and the filling/decompression speed of the balloon 100 can be increased, and the operation time can be accelerated.
  • the drug coated balloon catheter 1000 further includes a catheter hub 320 disposed at the proximal end of the push catheter 310.
  • the catheter hub 320 is secured to the proximal end of the push catheter 310.
  • the catheter hub 320 is provided with a guide wire port 15 in communication with the guidewire lumen 1 and a filling port 16 in communication with the filling lumen 2.
  • the first portion 311 of the push catheter 310 is provided with a balloon filling port 101.
  • the two ends of the filling chamber 2 are respectively connected to the filling port 16 and the balloon filling port 101.
  • the filling port 16, the filling chamber 2, and the balloon filling port 101 form a passage for filling and relieving the balloon 100.
  • the filling port 16 can be connected to an external pressure pump, and the pressurized liquid enters or flows out of the inside of the balloon 100 through the filling port 16, the filling chamber 2 and the balloon filling port 101 to achieve filling expansion or pressure relief of the balloon 100.
  • the first portion 311 of the pusher catheter 310 is provided with at least one development positioning device 111 to facilitate indicating the position of the balloon 100 by displaying the position of the development positioning device 111 under instrumental detection.
  • the development positioning device 111 is made of a radiopaque 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 pre-expansion mechanism 200 of the drug coated balloon catheter 1000 includes an expansion sleeve 220.
  • the dilatation sleeve 220 is used to receive the balloon 100 before the balloon 100 is unexpanded and pre-expanded.
  • the expansion sleeve 220 is movably disposed outside the push catheter 310 and receives the balloon 100 before the balloon 100 is expanded and pre-expanded.
  • the expansion sleeve 220 is a sleeve structure having an opening.
  • the proximal end portion of the dilatation sleeve 220 may have a shape that is convex toward the proximal end such as a cone, an arc, or the like, or may be a flush structure in which the proximal end surface is perpendicular or approximately perpendicular to the central axis, or may be concave toward the distal end. Concave structure.
  • the proximal end portion of the dilatation sleeve 220 has a tapered structure to improve the degree of fit of the dilatation sleeve 220 and the proximal end portion of the balloon 100.
  • the pre-expansion mechanism 200 of the drug coated balloon catheter 1000 includes a connector 240 that is coupled to the expansion sleeve 220.
  • the connector 240 is coupled to the expansion sleeve 220 and is moved axially relative to the push catheter 310 after the balloon 100 is pre-expanded to expose the balloon 100 outside of the expansion sleeve 220.
  • the connecting member 240 is a connecting tube.
  • the connecting tube is a hollow tubular structure having a certain axial length.
  • the connection between the expansion sleeve 220 and the connecting member 240 may be a common connection method in the field such as bonding, screwing, welding, interference fit, and the like.
  • the expansion sleeve 220 is detachably connected to the connecting member 240 to facilitate the replacement of the expansion sleeve 220.
  • the expansion sleeve 220 and the connector 240 can also be integrally formed.
  • the connector 240 is movably sleeved on the exterior of the pusher catheter 310, and both the expansion sleeve 220 and the connector 240 are movable in the axial direction of the pusher catheter 310.
  • the connecting member 240 can also be at least two connecting wires having a certain length, whereby the expansion sleeve 220 can be operated to advance or retract by the connecting wire.
  • the connector 240 can also be at least one solid connecting rod.
  • the number of connecting rods is preferably at least two, and in order to reduce the overall outer diameter profile of the entire instrument, the connecting rod is preferably a flat rod-like structure to better fit the push catheter.
  • the balloon 100 is filled and the expansion sleeve 220 is expanded, and the expansion sleeve 220 pre-expands the blood vessel of the lesion.
  • the expanded inner diameter of the dilatation sleeve 220 coincides with or is slightly larger than the diameter of the expanded balloon 100.
  • the expanded dilatation sleeve 220 has an inner diameter that is greater than the diameter of the pre-expanded balloon 100 (ie, the outer contour of the cylindrical working portion) by 0 to 0.10 mm. The purpose of this arrangement is to enable the balloon 100 to be smoothly accommodated in the expansion sleeve 200, and also to expand the expansion sleeve 220 covering the outside of the balloon 100 while pre-expansion.
  • the expansion sleeve 220 is retracted away from the balloon 100 to expose the balloon 100 to the outside of the expansion sleeve 220, that is, the balloon 100 is exposed to the vascular environment. . Subsequently, the balloon 100 is filled again, and the balloon 100 is expanded and treated for the blood vessel of the lesion, and the drug coating 30 on the surface of the balloon 100 is eluted from the surface of the balloon 100 and transferred to the inner wall of the blood vessel.
  • the balloon 100 is depressurized after the pre-expansion is completed to form a gap G between the balloon 100 and the dilatation sleeve 220.
  • the gap G between the balloon 100 and the expansion sleeve 220 is less than a predetermined threshold range
  • the balloon 100 is received in the expansion sleeve 220.
  • the connector 240 can be moved relative to the push catheter 310 toward the end remote from the balloon 100 to expose the balloon 100 outside of the dilation sleeve 220.
  • the preset threshold is approximately 0 mm - 10 mm.
  • Both the balloon 100 and the expansion sleeve 220 are made of a soft material and have a certain modulus of elasticity.
  • the balloon 100 and the dilatation sleeve 220 can be folded and wound together on the balloon prosthetic machine before being expanded or expanded.
  • the modulus of the material from which the first expansion sleeve 220 is made is less than the modulus of elasticity of the material from which the balloon 100 is made. Therefore, when the two are subjected to the same external pressure, the deformation amount of the balloon 100 is larger than the deformation amount of the expansion sleeve 220, and after the external pressure disappears, the speed at which the balloon 100 returns to the initial shape is also faster than the expansion sleeve 220 returns to the initial state. Faster.
  • the pressure liquid is introduced into the interior of the balloon 100, and the balloon 100 can be driven when the balloon 100 is filled and expanded.
  • the dilatation sleeve 220 disposed outside the balloon 100 expands together, and the two expand together to expand the blood vessel wall of the lesion portion to achieve pre-expansion of the inner wall of the blood vessel.
  • the balloon 100 After the pre-expansion is completed, the balloon 100 is released or not completely decompressed, the balloon 100 will return to the initial state or the incompletely expanded state at a relatively fast speed, and the expansion sleeve 220 will be restored to a slower speed to The initial state or the state of incomplete expansion. At this time, a large gap G is generated between the balloon 100 and the first expansion sleeve 220, and the operator only needs to withdraw the first expansion sleeve 220 to the proximal end, so that the balloon 100 is exposed to the lesion.
  • the balloon 100 can then be refilled, the balloon 100 expands the vessel wall of the lesion, and the drug coating 30 is eluted from the surface of the balloon 100 and transferred to the inner wall of the blood vessel to achieve treatment of the lesion.
  • the expansion sleeve 220 is preferably made of a material such as silica gel, polyurethane, or polyether amide, and is not limited thereto, as long as the elastic modulus of the expansion sleeve 220 is smaller than the elastic modulus of the balloon 100.
  • the proximal end of the connector 240 is provided with a handle 230.
  • the handle 230 moves axially relative to the catheter hub 320.
  • the user can operate the expansion sleeve 220 to withdraw proximally or push distally.
  • FIG. 3 to 9 show an implementation process of the drug-coated balloon catheter 1000 according to an embodiment of the present invention.
  • the drug coated balloon catheter 1000 is first pushed to the diseased vessel where expansion is desired.
  • the pressure liquid is introduced into the inner cavity of the balloon 100 to fill the balloon 100, and the expansion sleeve 220 sleeved outside the balloon 100 is simultaneously expanded until the expansion sleeve 220 fits the blood vessel wall of the lesion.
  • Pre-expansion of the stenosis of the vascular lesion Referring to FIG.
  • the filling liquid is pumped out by the balloon pressure pump, and the balloon 100 is gradually released to the initial open state or the incompletely expanded state, and at this time, due to the expansion sleeve 220.
  • the elastic modulus of the material is less than the elastic modulus of the material from which the balloon 100 is made, the balloon 100 will return to the initial state or the incompletely expanded state at a faster rate, and the expansion sleeve 220 will recover to a slower speed to In the initial state or the incompletely expanded state, when a large gap is created between the balloon 100 and the dilatation sleeve 220, the operator can withdraw the dilatation sleeve 220 proximally, exposing the balloon 100 to the blood vessel.
  • the balloon 100 is refilled, and the balloon 100 expands the blood vessel wall of the lesion, and the drug coating 30 is eluted from the surface of the balloon 100 and transferred to the inner wall of the blood vessel to realize treatment of the lesion.
  • a drug coated balloon catheter is provided in accordance with a second embodiment of the present invention.
  • 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 catheter 310, the catheter hub 320 is provided with two filling ports 16 and 17, and the push catheter 310 The interior of the interior is provided with two filling chambers 2 in the axial direction.
  • the number of balloons 100 can also be set to multiple.
  • a plurality of balloons 100 are connected in series and fixedly disposed on the push catheter 310, that is, the plurality of balloons 100 are coaxially disposed to be suitable for the treatment of multi-segment lesions of the same blood vessel.
  • the distal end of the push catheter 310 is provided with two balloons 100 for simultaneous expansion treatment of multiple lesions.
  • the push catheter 310 sequentially passes through the two balloons 100 in the axial direction and is sealingly coupled to both of the balloons 100.
  • the mutual position between the two balloons 100 is not limited, and only two of them are located at the distal end of the push catheter 310.
  • the two balloons 100 may be in close proximity to each other or may be spaced apart.
  • the shape of the two balloons 100 may be the same or different.
  • the two balloons 100 are generally cylindrical or spherical in shape.
  • the diameter of the two balloons 100 is selected according to the diameter of the diseased vessel to be treated, and the diameters of the two balloons may be the same or different.
  • the drug-coated balloon catheter with two balloons 100 provided in this embodiment can not only simultaneously treat different lesions, but also, after one of the balloons 100 is filled first, the filled balloon 100 also has a resistance.
  • the function of the broken blood flow can prevent the drug coating 30 on the surface of the other balloon 100 from being washed by the blood flow.
  • the surface of the first filled balloon 100 may be provided with no active drug coating to reduce the cost of the device.
  • each balloon 100 is housed within the same expansion sleeve 220 prior to unexpansion, and each balloon 100 is integrally flapped with the expansion sleeve 220 and wound into a cylinder.
  • each balloon 100 is received within a corresponding expansion sleeve 220 prior to unexpansion, that is, each balloon 100 is sleeved with an expansion sleeve 220.
  • each of the balloons 100 is respectively received in the corresponding expansion sleeve 220 before pre-expansion, and is folded together with the corresponding expansion sleeve 220 and wound into a cylinder.
  • the expansion sleeve 220 is movably sleeved on the push catheter 310 and sleeved on the outside of the corresponding balloon 100.
  • the number of expansion sleeves 220 is equal to or less than the number of balloons 100.
  • the two balloons 100 are housed together within an expansion sleeve 220.
  • each of the balloons 100 is correspondingly provided with an expansion sleeve 220, that is, the two expansion sleeves 220 are respectively disposed outside the two balloons 100. .
  • the pre-expansion mechanism 200 includes only one connector 240, and the connector 240 moves axially relative to the push catheter 310 after at least one of the balloons 100 is pre-expanded to cause the respective balloons 100. Exposed to the expansion sleeve 220.
  • the pre-expansion mechanism 200 includes a plurality of connectors 240 in one-to-one correspondence with the plurality of expansion sleeves 220, each of the connectors being axially moved relative to the push catheter 310 after the corresponding balloon 100 is pre-expanded, The balloon 100 is exposed outside the corresponding expansion sleeve 200.
  • the two expansion sleeves 220 are connected by a connecting member 240.
  • each expansion sleeve 220 is provided with a corresponding connector 240, respectively.
  • the two balloons 100 can be simultaneously filled, and the two expansion sleeves 220 are simultaneously expanded, and then the two balloons 100 are simultaneously vented.
  • the two expansion sleeves 220 can be simultaneously withdrawn from the patient's body.
  • the diameter of the connecting member 240 between the two expansion sleeves 220 is slightly larger than the outer diameter of the balloon 100 located closer to the proximal end, so that the connecting member 240 can be smoothly performed. withdraw.
  • the two expansion sleeves 220 can also be connected by at least two connecting wires or at least one solid rod.
  • the proximally located expansion sleeve 220 can also be coupled to the handle 230 by at least two connecting wires or at least one solid rod.
  • each of the connecting members 240 can have a hollow tubular structure, a filamentary structure, or a solid rod-like structure.
  • At least two first filling chambers 2 are disposed in the axial direction inside the pushing duct 310, and the inner chambers of each of the balloons 100 are respectively in communication with at least one filling chamber 2.
  • the pusher catheter 310 can be formed as an integrally formed multi-lumen tube or assembled from a plurality of separate tubes.
  • the pusher catheter 310 adopts an integrally formed multi-lumen tube.
  • the pusher catheter 310 is axially disposed with a mutually spaced guide wire lumen 1 and three filling chambers 2, wherein the two filling chambers 2 and one of the balls
  • the lumen of the balloon 100 is in communication and the third filling lumen 2 is in communication with the lumen of another balloon 100.
  • the guide wire cavity 1 and the three filling chambers 2 are arranged in parallel.
  • the cross-sectional shape of the multi-lumen tube is not limited, and only a plurality of functional cavities are required to be parallel 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 circular or elliptical.
  • the cross-sectional shape of the filling chamber 2 is not limited, and may be any shape.
  • the filling chamber 2 having the largest cross-sectional area is arranged according to the cross-sectional shape of the pushing duct 310, the position and shape of the guide wire chamber 1.
  • the push catheter 310 includes an outer tube 321 and two inner tubes 322 and 323 sleeved in the outer tube.
  • the lumen of one inner tube 322 serves as a guide wire lumen 1, and between the inner tube 322 and the outer tube 321
  • the space and the other inner tube 323 serve as two filling chambers 2, respectively.
  • the pusher catheter 310 can be sleeved to form a corresponding guide wire lumen 1 and a filling chamber 2. It can be understood that, in other embodiments, the specific structure of the push catheter 310 is not limited to the above embodiment, and may be various structures capable of forming the guide wire cavity 1 and the filling 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 guide wire port 15, two filling ports 16 and 17.
  • the guide wire port 15 is in communication with the guide wire lumen 1.
  • a guide wire (not shown) is inserted through the guide wire port 15, the passage formed by the guide wire lumen 1.
  • a balloon filling port 101 is opened in the tube body of the push catheter 310 in one of the balloons 100, and a balloon filling port 102 is opened in the tube body of the pushing catheter 310 in the other of the balloons 100. Both ends of a filling chamber 2 are in communication with the filling port 16 and the balloon filling port 101, respectively.
  • the other ends of the other filling chamber 2 are in communication with the filling port 17 and the balloon filling port 102, respectively.
  • the filling port 16, the filling chamber 2, and the balloon filling port 101 form a passage for filling and relieving pressure of one of the balloons 100.
  • the filling port 17, the filling chamber 2 and the balloon filling port 102 form a passage for filling and relieving pressure of the other of the balloons 100.
  • the expansion sleeve is set on the surface of the balloon, and is pushed together with the balloon to the lesion site, and then the expansion sleeve is expanded, and the lesion portion can be effectively pre-expanded;
  • the expansion sleeve has a protective effect on the drug coating on the surface of the balloon, which can reduce the drug loss rate during the delivery process;
  • the balloon at the proximal end 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 distal surface of the balloon, reducing the drug loss rate and improving The amount and efficiency of drug transfer from the balloon surface to the vessel wall.
  • a drug coated balloon catheter is provided in accordance with 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 350 that slides relative to the push catheter 310, wherein one drug coated balloon 100 is fixedly disposed on the push catheter 310, wherein the other drug coated balloon 400 is fixedly It is disposed on the sliding duct 350.
  • the number of balloons may be set to multiple and the distance between the plurality of balloons may be adjusted.
  • the drug-coated balloon catheter 3000 includes a push catheter 310, a balloon 100 disposed at a distal end of the push catheter 310, a pre-expansion mechanism 200, a sliding catheter 350, and a
  • the balloon 400 at the distal end of the catheter 350 is slid. At least a portion of the surface of balloon 100 and balloon 400 covers drug coating 30.
  • the pre-expansion mechanism 200 includes an expandable expansion sleeve 220 that is movably sleeved outside of the balloon 100, and a connector 240 that is coupled to the expansion sleeve 220.
  • the connector 240 is sleeved on the outside of the pusher catheter 310 and moves axially relative to the pusher catheter 310.
  • the structure of the balloon 100 and the expansion sleeve 220 and the mutual positional relationship and the connection relationship are the same as those in the first embodiment, and are not described herein again.
  • At least one balloon 400 is disposed at a distal end of the sliding catheter 350.
  • a guide wire lumen 1 and a filling chamber 2 are axially disposed within the pusher catheter 310 of the drug-coated balloon catheter 3000.
  • An inner lumen 324 may also be disposed in the push conduit 310, and the sliding conduit 350 is movably disposed through the inner lumen 324 of the push conduit 310.
  • the distal end of the sliding catheter 350 is threaded out of the wall of the push catheter 310 near the distal end.
  • the through hole 318 is formed in the side wall of the distal end of the push tube 310, and the side hole 221 is correspondingly formed on the tube body of the connecting member 240.
  • the corresponding means that the distal end portion of the expansion sleeve 220 is sleeved.
  • the through hole 318 and the side hole 221 coincide with each other.
  • the distal end of the sliding catheter 350 passes through the through hole 318 and the side hole 221 and is connected to the proximal end of the balloon 400. Since the sliding catheter 350 can slide axially between the push catheter 310, the distance between the balloon 400 disposed at the distal end of the sliding catheter 350 and the balloon 100 disposed distally of the push catheter 310 can be adjusted to accommodate the bifurcated vessel Different branch vascular lesions.
  • the distal end of the push catheter 310 and the distal end of the sliding catheter 350 can also be respectively formed by a bifurcated tube body (such as a Y-shaped tube having at least two bifurcations).
  • a branch tube is passed through, and the sliding catheter 350 can also slide axially between the push catheter 310 such that the distance between the balloon 400 and the balloon 100 can be adjusted to treat the bifurcated blood vessel.
  • a bifurcated tube body (such as a Y-shaped tube having at least two bifurcations) may be provided at the distal end of the push catheter 310, and the distal end of the sliding catheter 350 is one of the distal ends.
  • the root branch body is pierced, and the sliding catheter 350 can also slide axially between the push catheter 310 so that the distance between the balloon 400 and the balloon 100 can be adjusted to treat the bifurcated blood vessel.
  • the surface of the expansion sleeve 220 should be provided in a tearable form, such as a point break, and the point break is preferably a bifurcation corresponding to the bifurcated tube body. At the office.
  • the point breakage can be gradually torn from the bifurcation, which facilitates the retraction of the expansion sleeve 220.
  • the pre-expansion mechanism 200 includes an expansion sleeve 220.
  • the balloon 100 and the balloon 400 are housed in the same expansion sleeve 220 before and during pre-expansion and the balloon 100 and the balloon 400 are folded together with the expansion sleeve 220 and wound into a cylinder.
  • the pre-expansion mechanism 200 includes a connector 240 that connects the expansion sleeve 220.
  • the connector 240 is axially moved relative to the push catheter 310 after the balloon 100 is pre-expanded to expose the respective balloons 100, 400 to the outside of the expansion sleeve 220, or to move axially relative to the sliding catheter 350 after the balloon 400 is pre-expanded. So that each of the balloons 100 and 400 is exposed outside the expansion sleeve 220.
  • a guide wire lumen 4 and a filling chamber 5 are provided in the axial direction of the sliding duct 350.
  • the guidewire lumen 4 extends through the proximal and distal ends of the sliding catheter 350 for threading the guidewire.
  • the filling chamber 5 communicates with the lumen of the balloon 400 for filling and relieving pressure of the balloon 400.
  • a proximal end of the sliding catheter 350 is also provided with a catheter hub 330. That is, the catheter hub 330 is also movably sleeved outside the pusher catheter 310 and axially relative to the pusher catheter 310.
  • the proximal end of the catheter hub 330 is provided with a guide wire port 17 and a filling port 18.
  • the guidewire port 17 is connected to the proximal end of the guidewire lumen 4.
  • the filling port 18 is connected to the proximal end of the filling chamber 5.
  • the balloon 400 is fixed to the distal end of the sliding catheter 350 by welding, bonding, or the like. At least a portion of the outer surface of balloon 400 is covered with drug coating 30.
  • the structure of the balloon 400 is substantially the same as that of the balloon 100 of the first embodiment, and will not be described herein.
  • the structure of the balloon 400 can be different from the structure of the balloon 100 of the first embodiment.
  • the diameter of the portion of the balloon 400 near the proximal end gradually decreases from the distal end to the proximal end.
  • the balloon 400 is generally tapered, i.e., has a proximal diameter that is small and a distal diameter that is generally tapered.
  • the proximal and distal portions of the second balloon 400 are generally conical, the central portion is cylindrical, and a smooth transition between the cylindrical shape and the conical shape.
  • proximal end portion and the distal end portion of the balloon 400 are substantially tapered, and the central portion is cylindrical.
  • the diameter between the cylindrical portion and the tapered portion is different to form a stepped structure.
  • the tapered structure of the proximal end of the balloon 400 is generally long tapered, that is, the taper change is small to form a long taper having a small length and a small diameter, and the taper diameter is much smaller than the cylindrical portion. .
  • the tapered, long-tapered structure can increase the spacing between the balloon 100 and the balloon 400, avoiding the problem of excessive fit or small distance between the two after filling, causing excessive blood vessel dilation, tearing of the blood vessel or formation of a sandwich, and increasing the balloon. The effective working length after expansion and filling.
  • 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 drug coated balloon catheter 4000 further includes a stop member 360 for connecting the push catheter 310 and the sliding catheter 350.
  • the push catheter 310 and the sliding catheter 350 are disposed substantially in parallel, and the axial directions of the two balloons 100 and 400. parallel.
  • the sliding duct 350 can also be disposed substantially in parallel with the pushing duct 310 , and the two are connected by the limiting member 360 .
  • the stop member 360 can cause axial mutual movement between the push catheter 310 and the sliding catheter 350 without radial offset.
  • the limiting member 360 has various embodiments.
  • the limiting member 360 may be a collar or a hoop member disposed between the pushing conduit 310 and the sliding conduit 350.
  • the pushing conduit 310 and the sliding conduit 350 are movably disposed in the sleeve. Inside the ring or hoop member, thereby defining only axial movement between the two.
  • the limiting member 360 may also be a tubular body having a certain axial length, or a third tubular body in which the push conduit 310 and the sliding conduit 350 are sleeved together.
  • the specific shape and axial length of the limiting member 360 are not limited, and may be adjusted according to the lengths of the pushing duct 310 and the sliding duct 350.
  • the stop member 360 can be a round, elliptical or "8" shape. It will be appreciated that in order to reduce the overall diameter of the drug coated balloon catheter, the shape of the push catheter 310 and the sliding catheter 350 preferably cooperate. Form a complete, angular shape, such as a circle or an ellipse.
  • the pre-expansion mechanism 200 includes expansion sleeves 222 and 224 that are in one-to-one correspondence with the balloon 100 and the balloon 400.
  • the balloon 100 is received in one of the expansion sleeves 222 prior to pre-expansion and is folded together with the expansion sleeve 222 and wound into a cylinder.
  • the balloon 400 is received within the other of the expansion sleeves 224 prior to pre-expansion and is folded together with the expansion sleeve 224 and wound into a cylinder.
  • the structure of the expansion sleeves 222 and 224 is substantially the same as that of the expansion sleeve 220, and will not be described herein.
  • the inner diameter of the expanded dilatation sleeve 224 coincides with or is slightly larger than the diameter of the expanded balloon 400.
  • the pre-expansion mechanism 200 includes a plurality of connectors 242 and 244 that are in one-to-one correspondence with the expansion sleeves 222 and 224.
  • one of the connectors 242 is axially moved relative to the push catheter 310 after the balloon 100 is pre-expanded to expose the balloon 100 to the outside of the expansion sleeve 222, or the other connector 244 is in the balloon.
  • the relative sliding catheter 350 is moved in the axial direction to expose the balloon 400 to the outside of the expansion sleeve 224.
  • the proximal end of the expansion sleeve 224 is provided with a connecting tube 244.
  • the connecting tube 244 is movably sleeved outside the sliding duct 350 and moves relative to the sliding duct 350 in the axial direction. After the connecting tube 244 and the sliding duct 350 are sleeved together, they are commonly worn in the inner cavity of the pushing duct 310 and simultaneously pass through the through holes of the side wall of the distal end of the pushing duct 310. Both the expansion sleeve 224 and the balloon 400 can be moved relative to the balloon 100 and the expansion sleeve 222 to adjust the mutual positional relationship therebetween.
  • the connecting tube 244 can also select other embodiments such as a filament structure or a solid rod-shaped structure, and details are not described herein again.
  • the expansion sleeve is set on the surface of the two balloons, and is pushed together with the two balloons to the lesion site, and then the expansion sleeve is expanded, and the lesion portion can be effectively pre-expanded;
  • the expansion sleeve has a protective effect on the drug coating on the surface of the balloon, which can reduce the drug loss rate during the delivery process;
  • One of the balloons may be placed in an irregular shape to avoid tearing the blood vessels at the bifurcation position.
  • the drug-coated balloon catheter of the present invention can effectively protect the drug-coated ball by providing a pre-expansion mechanism on the outside of the drug-coated balloon to transport the pre-expansion mechanism and the drug-coated balloon together to the lesion site.
  • the capsule is protected from blood flow and reduces drug loss during transport; the pre-expansion mechanism achieves pre-expansion of the lesion, so that the drug-coated balloon can smoothly enter the lesion, and the inner wall of the lesion can be increased with the drug-coated balloon.
  • the area of surface contact increases the amount of drug-coated balloon transferred to the vessel wall and improves the therapeutic effect; no additional pre-expanded balloon is needed, which reduces the complexity of surgery and the cost of surgery, and saves operation time.

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Abstract

一种药物涂层球囊导管(1000)，包括推送导管(310)、位于推送导管(310)远端的至少一个可扩张的第一球囊(100)及预扩张机构。第一球囊(100)固定地设置在推送导管(310)上。预扩张机构(200)包括扩张套(220)及连接件(240)。扩张套(220)用于在第一球囊(100)未扩张前及预扩张时收容第一球囊(100)。连接件(240)连接扩张套(220)，且在第一球囊(100)预扩张后相对推送导管(310)沿轴向运动，以使第一球囊(100)裸露在扩张套(220)外。该药物涂层球囊导管(1000)既可对病变部位进行有效地预扩张，同时可有效避免药物涂层球囊在输送过程中的损失，且手术操作过程简单。

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，涉及一种药物涂层球囊导管。
背景技术
动脉血管狭窄一直以来是困扰人类的一类疾病，为了治愈这类疾病，人类先后经历了裸球囊、裸支架、药物洗脱支架等治疗阶段，然而前述治疗方案均具有不同缺陷。当前，药物涂层球囊导管应运而生，它不仅通过球囊扩张为血液流通建立通道，而且球囊上载有的药物可以有效抑制平滑肌细胞的增生，防止血管再狭窄。
在使用药物涂层球囊对病变部位进行扩张治疗之前，需要先使用普通的无药球囊对病灶进行预扩张，使得药物涂层球囊可顺利进入病灶，并避免一次性过度扩张导致的血管损伤。然而，预扩张需要使用额外的普通球囊，既增加了手术的复杂程度，且在预扩张之后，药物涂层球囊在输送过程中被高速流动的血液冲刷会导致药量的损失。
发明内容
鉴于现有技术中存在的上述问题，本发明提供一种操作简单且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；
第一球囊，固定地设置在所述推送导管上；及
预扩张机构，包括：
扩张套，用于在所述第一球囊未扩张前及预扩张时收容所述第一球囊，及
连接件，连接所述扩张套，且在所述第一球囊预扩张后相对所述推送导管沿轴向运动，以使所述第一球囊裸露在所述扩张套外。
本发明通过在药物涂层球囊导管的外部设置预扩张机构，至少具有以下有益效果：
(1)预扩张机构与药物涂层球囊共同输送至患者体内，预扩张机构对病变部位实现预扩张，使得药物涂层球囊可顺利进入病灶，增加了病变部位的血管内壁可与药物涂层球囊表面接触的面积，增加了药物涂层球囊扩张后转移至血管壁的药量，提高了治疗效果；
(2)预扩张机构套设在药物涂层球囊外，在使用过程中同药物涂层球囊共同输送至病变部位，可有效保护药物涂层球囊免受血流冲刷，减少输送过程中的药物损失；
(3)无需使用额外的预扩张球囊，降低手术复杂程度及手术成本，节约手术时间。
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中的药物涂层球囊导管的推送导管沿II-II线的剖面图；
图3是图1中的药物涂层球囊导管在球囊预扩张前的示意图；
图4是图3中的药物涂层球囊导管沿IV-IV线的剖面图；
图5是图1中的药物涂层球囊导管在球囊预扩张后的示意图；
图6是图5中的药物涂层球囊导管沿VI-VI线的剖面图；
图7是图1中的药物涂层球囊导管在在扩张套朝远离球囊一侧运动后的示意图；
图8是图7中的药物涂层球囊导管沿VIII-VIII线的剖面图；
图9是图1中的药物涂层球囊导管的球囊在预扩张后再扩张的结构示意图；
图10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11是图10中的药物涂层球囊导管的推送导管的第一实施方式的结构示意图；
图12是图10中的药物涂层球囊导管的推送导管的第二实施方式的结构示意图；
图13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14是图13中的药物涂层球囊导管沿XIV-XIV线的剖面图。
图15是本发明第四实施例提供的药物涂层球囊导管的结构示意图；
图16是图15中的药物涂层球囊导管沿XVI-XVI线的剖面图。
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，远端是指器械可自由插入到动物或人体体内的一端。近端是指供用户或机器操作的一端或是用于连接其他器件的一端。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，其包括推送导管、位于推送导管远端的至少一个可扩张的第一球囊、及预扩张机构。第一球囊的至少部分表面覆盖药物涂层。预扩张机构包括活动地套设在第一球囊外的可膨胀的扩张套、及与扩张套的近端连接的连接件。连接件沿轴向与推送导管相对运动。
请一并参见图1至图9，为本发明第一实施例提供的药物涂层球囊导管1000。药物涂层球囊导管1000包括推送导管310、设置在推送导管310上的球囊100及预扩张机构200。推送导管310具有相对的插入端(即远端)和操作端(即近端)。球囊100位于推送导管310的远端。球囊100的外表面至少部分涂覆一层药物涂层30。
如图3和图4所示，球囊100在扩张前具有多个折翼。可选的，球囊100在扩张前具有三至六个折翼。球囊100固定在推送导管310的远端。固定的方式为焊接、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。球囊100由近端部、远端部及二者之间的工作部组成。其中球囊100的近端部及远端部均大致呈锥形，球囊100的工作部大致呈圆柱形。工作部位于球囊100的中间位置。工作部的直径大约为2-15mm。球囊100的长度大约为30-320mm。球囊100的有效长度(即，工作部的长度)大约为20-300mm。球囊100的直径、长度及有效长度等规格尺寸根据需治疗的病变血管直径选择。药物涂层30主要设置在球囊100的工作部。药物涂层30中含有具备抑制平滑肌细胞增生作用的活性药物，如紫杉醇、雷帕霉素等。药物涂层30中还含有多元醇、有机酸盐等作为载体，本实施例中，采用紫杉醇作为活性药物，甘露醇作为载体。药物涂层30的涂覆为现有技术，在此不再赘述。球囊100的工作部为圆柱形，使得充盈后的球囊100具有良好贴壁性，并可以有一定长度贴附血管内壁，能有效地将活性药物转移到血管壁面上。
如图1和图2所示，在本实施例中，推送导管310沿轴向穿过球囊100的两端，并且与球囊100密封连接。推送导管310具有收容在球囊100内的第一部分311和裸露在球囊100外的第二部分312。推送导管310沿轴向设置有导丝腔1和与导丝腔1隔离设置的充盈腔2。导丝腔1及充盈腔2的腔体之间互不连通。导丝腔1贯穿推送导管310且与球囊100相连通。导丝腔1用于穿装导丝(图未示出)。在一实施例中，充盈腔2的数量为一个，充盈腔2的远端与球囊100的内部相连通用于球囊100的充盈及泄压。可以理解的，在另一实施例中， 为了提高球囊100的充盈及泄压速度，充盈腔2的数量可以为多个，且每个充盈腔2均与球囊100的内腔连通。由此，单位时间内流入/流出球囊100的液体量增大，可提高球囊100的充盈/泄压速度，加快手术时间。
请再次参见图1和图2，药物涂层球囊导管1000还包括设置在推送导管310近端的导管座320。导管座320固定于推送导管310的近端。导管座320设置有与导丝腔1连通的导丝端口15及与充盈腔2连通的充盈端口16。推送导管310的第一部分311开设有球囊充盈口101。充盈腔2两端分别与充盈端口16和球囊充盈口101相连通。由此，充盈端口16、充盈腔2和球囊充盈口101形成对球囊100进行充盈及泄压的通道。充盈端口16可连接外部压力泵，压力液体经由充盈端口16、充盈腔2及球囊充盈口101进入或者流出球囊100内部，以实现球囊100的充盈膨胀或泄压。
推送导管310的第一部分311设置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的位置指示球囊100的位置。显影定位装置111由不透射线的材料制成，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。
药物涂层球囊导管1000的预扩张机构200包括扩张套220。扩张套220用于在球囊100未扩张前及预扩张时收容球囊100。具体的，扩张套220活动地套设在推送导管310外，且在球囊100未扩张前及预扩张时收容球囊100。扩张套220为具有开口的套筒结构。扩张套220的近端部可以是锥形、弧形等向近端凸出的形状，也可以是近端端面垂直或近似垂直于中轴线的齐平结构，也可以是向远端凹入的内凹结构。具体地，本实施中，扩张套220的近端部为锥形结构，以提高扩张套220与球囊100的近端部的贴合度。
药物涂层球囊导管1000的预扩张机构200包括与扩张套220连接的连接件240。连接件240连接扩张套220，且在球囊100预扩张后相对推送导管310沿 轴向运动，以使球囊100裸露在扩张套220外。具体地，本实施例中，连接件240为连接管。连接管为具有一定轴向长度的空心管状结构。在一实施例中，扩张套220与连接件240的连接方式可以是粘接、螺纹连接、焊接、过盈配合等本领域通用的连接方式。可选的，扩张套220与连接件240可拆卸连接，以方便扩张套220更换。可以理解的是，在其他实施例中，扩张套220与连接件240也可以一体成型。连接件240活动地套设在推送导管310的外部，且扩张套220和连接件240均可以沿推送导管310的轴向运动。可以理解的是，在其他实施例中，连接件240也可以是至少两根具有一定长度的连接丝，由此通过连接丝即可操作扩张套220前进或后撤的。还可以理解的是，在其他实施例中，连接件240还可以是至少一根实心的连接杆。为了平稳地操作扩张套220的前进或后撤，连接杆的数量优先为至少两根，且为了减小整个器械的整体外径轮廓，连接杆优选为扁平杆状结构，以更加贴合推送导管310的外壁。请一并参见图3和图4，在球囊100预扩张前，扩张套220套设在球囊100的外部且与预扩张前的球囊100共同折翼并卷绕成柱体，例如是圆柱体或棱柱体。折翼并卷绕的过程可以在球囊折翼机等机器上进行。
请一并参见图3至图6，扩张套220和球囊100共同送入病变部位后，球囊100被充盈并带动扩张套220膨胀，扩张套220对病变部位血管进行预扩张。膨胀后的扩张套220的内径与扩张后的球囊100的直径一致或者稍大于预扩张后的球囊100的直径。优选地，膨胀后的扩张套220内径比预扩张后的球囊100的直径(即，圆柱形工作部的外轮廓)大0～0.10mm。如此设置的目的是，既使得球囊100可顺利地收容在扩张套200中，预扩张时也带动覆盖在球囊100外部的扩张套220同时膨胀。
请一并参见图7至图9，预扩张完成后，将扩张套220朝远离球囊100的方向后撤，以使球囊100裸露于扩张套220外，也即球囊100暴露于血管环境。随后，再对球囊100进行充盈，球囊100对病变部位血管进行扩张治疗，球囊100表面的药物涂层30自球囊100的表面洗脱并转移至血管内壁。
可以理解的，在本实施例中，球囊100在预扩张完成后进行泄压，以使球囊100与扩张套220之间形成间隙G。当球囊100与扩张套220之间的间隙G小于预设阈值范围时，球囊100收容于扩张套220内。当球囊100与扩张套220之间的间隙G大于预设阈值范围时，连接件240可相对推送导管310朝远离球囊100的一端运动，以使球囊100裸露在扩张套220外。所述预设阈值大致为0mm-10mm。
球囊100和扩张套220均由软性材料制成并具有一定弹性模量。由此，球囊100和扩张套220在没有扩张或者膨胀前，可在球囊折翼机上被共同折翼并卷绕。制成第一扩张套220的材料的弹性模量小于制成球囊100的材料的弹性模量。因此，二者在受到相同的外部压力时，球囊100的形变量大于扩张套220的形变量，在外部压力消失后，球囊100恢复初始形态的速度也较扩张套220恢复初始状态的速度更快。由此，在将球囊100及套设于球囊100外部的扩张套220共同推送至病变部位的血管壁之后，向球囊100的内部通入压力液体，球囊100充盈扩张时可带动套设在球囊100外部的扩张套220共同膨胀，二者共同扩张至扩张套220贴合病变部位的血管壁，实现对血管内壁的预扩张。预扩张完成后，对球囊100进行泄压或者不完全泄压，球囊100会以较快的速度恢复至初始状态或者不完全扩张状态，而扩张套220则会以较慢的速度恢复至初始状态或者不完全扩张状态。此时，球囊100与第一扩张套220之间产生较大的间隙G，操作者只需将第一扩张套220向近端后撤，即可使得球囊100暴露于病变部位。之后即可对球囊100进行再次充盈，球囊100对病变部位血管壁进行扩张，同时药物涂层30自球囊100的表面洗脱并转移至血管内壁，实现对病变部位的治疗。扩张套220优选采用硅胶、聚氨酯、聚醚酰胺等材料制成，具体不作限制，只要制成扩张套220的弹性模量小于制成球囊100的弹性模量即可。
请再次参见图1，连接件240的近端设置有手柄230。手柄230沿轴向与导管座320相对运动。由此，使用者通过手持手柄230，即可操作扩张套220向近端后撤或者向远端推送。
如图3至图9所示为本发明实施例提供的药物涂层球囊导管1000的实施过程。请参见图3，首先将药物涂层球囊导管1000推送至需要扩张的病变血管处。请参见图5，向球囊100的内腔中通入压力液体使得球囊100充盈，并带动套设在球囊100外部的扩张套220同时膨胀，直至扩张套220贴合病变部位的血管壁，对血管病变狭窄处进行预扩张。请参见图7，预扩张完成后，通过球囊压力泵将充盈液体抽出，球囊100泄压后逐渐恢复至初始的空瘪状态或者不完全扩张状态，此时，由于制成扩张套220的材料的弹性模量小于制成球囊100的材料的弹性模量，球囊100会以较快的速度恢复至初始状态或者不完全扩张状态，而扩张套220则会以较慢的速度恢复至初始状态或者不完全扩张状态，当球囊100与扩张套220之间产生较大的间隙，操作者可将扩张套220向近端后撤，将球囊100暴露在血管中。请参见图9，再次充盈球囊100，球囊100对病变部位血管壁进行扩张，同时药物涂层30自球囊100的表面洗脱并转移至血管内壁，实现对病变部位的治疗。
如图10所示，为本发明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设有两充盈端口16和17，以及所述推送导管310的内部沿轴向设置两充盈腔2。可以理解的，在其他实施例中，球囊100的数量还可设置为多个。可选的，多个球囊100串联且固定设置在推送导管310上，也即多个球囊100同轴设置，以适用于同一根血管的多节段病变的治疗。
具体地，请参见图10，推送导管310的远端设置有两个球囊100，以便对多个病变部位同时扩张治疗。推送导管310沿轴向依次穿过两个球囊100，并且与两个球囊100均密封连接。两个球囊100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。两个球囊100可以彼此紧邻，也可以间隔设置。两 个球囊100的形状可以相同，也可以不同。两个球囊100的形状通常为圆柱形或球形。两个球囊100的直径根据需要治疗的病变血管直径选择，二者的直径可以相同也可以不同。本实施例提供的具有两个球囊100的药物涂层球囊导管不仅可以针对不同病灶同时进行处理，同时，在其中一个球囊100先被充盈后，该被充盈的球囊100还具有阻断血流的作用，可避免另外一个球囊100表面的药物涂层30被血流冲刷。在这种情况下，先充盈的球囊100的表面可以不设置活性药物涂层，以降低器械的成本。
可以理解的，在一实施例中，各个球囊100在未扩张前均收容在同一扩张套220内，且各个球囊100与扩张套220共同折翼并卷绕成柱体。在另一实施例中，各个球囊100在未扩张前收容于对应的扩张套220内，也即每一球囊100套设有扩张套220。可选的，各个球囊100在预扩张前分别收纳于对应的扩张套220内，并且与对应的扩张套220共同折翼并卷绕成柱体。
具体的，扩张套220活动地套设在推动导管310上，且套设在对应球囊100的外部。扩张套220的数量等于或小于球囊100的数量。具体的，在一实施例中，两个球囊100共同容置于一个扩张套220内。在另一实施例中，当两个球囊100相隔距离较远时，每一球囊100对应设置一个扩张套220，也即两个扩张套220分别对应套设在两个球囊100的外部。
可以理解的，在一实施例中，预扩张机构200仅包括一个连接件240，且连接件240在其中至少一个球囊100预扩张后相对推送导管310沿轴向运动，以使各个球囊100裸露在扩张套220外。在另一实施例中，预扩张机构200包括与多个扩张套220一一对应的多个连接件240，每一连接件在对应的球囊100预扩张后相对推动导管310沿轴向运动，以使球囊100裸露在对应的扩张套200外。
具体的，在一实施例中，两个扩张套220之间通过一个连接件240相连接。在另一实施例中，各扩张套220分别设置有对应的连接件240。由此，在整个器械(也即药物涂层球囊导管2000)到达病变部位后，可同时充盈两个球囊100，并带动两个扩张套220共同膨胀，之后对两个球囊100同时泄压，即可将两个扩 张套220同时撤出患者体外。可以理解的是，在这种实施方式中，优选位于两个扩张套220之间的连接件240的直径略大于位于较靠近近端的球囊100的外径，使得该连接件240可顺利后撤。
可以理解的是，在其他实施例中，两个扩张套220之间也可以通过至少两根连接丝或者至少一根实心杆相连。且位于近端的扩张套220也可以通过至少两根连接丝或者至少一根实心杆与手柄230相连。换言之，每个连接件240均可具有空心管状结构、丝状结构或者实心杆状结构。
如图11所示，推送导管310内沿轴向设置至少两个第一充盈腔2，且每个球囊100的内腔分别与至少一个充盈腔2相连通。推送导管310可以采用一体成型的多腔管，也可以通过多根单独的管体组装在一起形成。
请参见图11，推送导管310采用一体成型的多腔管，推送导管310内沿轴向设置有相互隔开的导丝腔1及三个充盈腔2，其中两个充盈腔2与其中一个球囊100的内腔连通，第三个充盈腔2与另一个球囊100的内腔连通。导丝腔1及三个充盈腔2两两平行设置。多腔管的横截面形状不作限定，只需多个功能腔体相互平行即可。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，一般导丝腔1的横截面选用圆形或椭圆形等形状。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、导丝腔1的位置和形状，排布具备最大横截面积的充盈腔2。
请参见图12，推送导管310包括外管321和套设在外管中的两个内管322及323，其中一个内管322的管腔作为导丝腔1，内管322与外管321之间的空间以及另一个内管323分别作为两个充盈腔2。推送导管310除了上述结构，还可以多管套设形成对应的导丝腔1及充盈腔2。可以理解的是，在其他实施例中，推送导管310的具体结构不局限于上述实施例，可以是能形成导丝腔1、充盈腔2的各种结构。
请再次参见图10，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、两充盈端口16及17。导丝端口15与导丝腔1连通。通过导丝端口 15、导丝腔1形成的通道穿装导丝(图未示出)。推送导管310的位于其中一个球囊100内的管体上开有球囊充盈口101，推送导管310的位于其中另一个球囊100内的管体上开有球囊充盈口102。一个充盈腔2的两端分别与充盈端口16和球囊充盈口101相连通。另一个充盈腔2的两端分别与充盈端口17和球囊充盈口102相连通。由此，充盈端口16、充盈腔2和球囊充盈口101形成对其中一个球囊100进行充盈及泄压的通道。充盈端口17、充盈腔2和球囊充盈口102形成对其中另一个球囊100进行充盈及泄压的通道。
本实施例的药物涂层球囊导管，与现有技术相比，至少具有如下有益效果：
(1)扩张套套设在球囊的表面，与球囊共同推送至病变部位，之后扩张套扩张，可对病变部位进行有效的预扩张；
(2)扩张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；
(3)可以利用多个球囊一次性处理多节段病变；
(4)位于近端的球囊可以作为封堵球囊，暂时阻断血管中的血液流动，进一步避免血液对位于远端的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。
如图13所示，为本发明第三实施例提供的药物涂层球囊导管。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350，其中一个药物涂层球囊100固定地设置在推送导管310，其中另一个药物涂层球囊400固定地设置在滑动导管350。可以理解的，在其他实施例中，球囊的数量可设置为多个，且多个球囊之间的距离可调整。在本实施例中，药物涂层球囊导管3000在受压充盈时，两球囊100和400的轴向之间存在夹角α，也即两球囊100，400并非同轴设置，也即球囊100的所在轴与球囊400的所在轴之间形成夹角α， 以适用于分叉血管的不同分支血管病变的治疗。
具体地，请参见图13，在本实施例中，药物涂层球囊导管3000包括推送导管310、设置在推送导管310的远端的球囊100、预扩张机构200、滑动导管350及设置在滑动导管350的远端的球囊400。球囊100和球囊400的至少部分表面覆盖药物涂层30。预扩张机构200包括活动地套设在球囊100外部的可膨胀的扩张套220、及与扩张套220连接的连接件240。连接件240套设在推送导管310的外部，且沿轴向相对推送导管310运动。其中球囊100、扩张套220的结构以及相互位置关系和连接关系同实施例一，在此不再赘述。
滑动导管350的远端设置至少一个球囊400。药物涂层球囊导管3000的推送导管310内沿轴向设置有导丝腔1和充盈腔2。推送导管310内还可以多设置一个内腔324，滑动导管350活动地穿设于推送导管310的内腔324。滑动导管350的远端自推送导管310的靠近远端的管壁穿出。穿出的方式可以是：在推送导管310远端侧壁开有通孔318，连接件240的管体上相应地开设侧孔221，所述相应是指，在扩张套220的远端部套设至球囊100的远端部时，通孔318与侧孔221彼此重合。此时，滑动导管350的远端自通孔318及侧孔221穿出并与球囊400的近端相连。由于滑动导管350可以沿轴向与推送导管310之间滑动，使得滑动导管350远端设置的球囊400与推送导管310远端设置的球囊100之间的距离可以调整，以适应分叉血管的不同分支血管病变。
可以理解的是，在其他实施例中，还可将推送导管310的远端及滑动导管350的远端分别由一根分叉管体(如具有至少两个分叉的Y型管)的其中一根分支管体中穿出，此时滑动导管350也可以沿轴向与推送导管310之间滑动，使得球囊400与球囊100之间的距离可以调整，以治疗分叉血管。
还可以理解的是，在其他实施例中，还可以在推送导管310的远端设置一段分叉管体(如具有至少两个分叉的Y型管)，滑动导管350的远端由其中一根分支管体中穿出，此时滑动导管350也可以沿轴向与推送导管310之间滑动，使得球囊400与球囊100之间的距离可以调整，以治疗分叉血管。但是为了避免影 响扩张套220膨胀后向近端后撤，扩张套220的表面应设置为可撕裂形式，例如点断线，且所述点断线优选为对应于分叉管体的分叉处。由此，在扩张套220后撤时，点断线可自分叉处逐渐撕裂，利于扩张套220的后撤。
可以理解的，在本实施例中，预扩张机构200包括一个扩张套220。球囊100和球囊400在未扩张前及预扩张时均收容在同一个扩张套220内且球囊100和球囊400与扩张套220共同折翼并卷绕成柱体。
在一实施例中，预扩张机构200包括一个连接扩张套220的连接件240。连接件240在球囊100预扩张后相对推送导管310沿轴向运动，以使各个球囊100，400裸露在扩张套220外，或是球囊400预扩张后相对滑动导管350沿轴向运动，以使各个球囊100和400裸露在扩张套220外。如图14所示，滑动导管350内沿轴向设有导丝腔4和充盈腔5。导丝腔4贯穿滑动导管350的近端和远端，用于穿装导丝。充盈腔5与球囊400的内腔连通，用于球囊400的充盈及泄压。
滑动导管350近端还设有导管座330。即，导管座330也活动地套设在推送导管310外，且与推送导管310之间沿轴向相对运动。导管座330的近端设有导丝端口17及充盈端口18。导丝端口17与导丝腔4的近端相连。充盈端口18与充盈腔5的近端相连。
球囊400通过焊接、粘接等方式固定在滑动导管350的远端。球囊400的至少部分外表面覆盖药物涂层30。球囊400的结构与实施例一的球囊100的结构基本相同，在此不再赘述。
还可以理解的是，在其他实施例中，球囊400的结构与实施例一的球囊100的结构也可以不同。具体地，请参见图13，球囊400靠近近端的部分的直径由远端至近端逐渐减小。这种逐渐减小的结构有多种实施方式，例如：球囊400整体为锥形，即近端直径小，远端直径大的大致锥形。或者第二球囊400的近端部和远端部为大致锥形，中部为圆柱形，圆柱形与锥形之间平滑过渡。再或者球囊400近端部和远端部为大致锥形，中部部分为圆柱形，圆柱形与锥形之间直径不同形成阶梯结构。球囊400近端部的锥形结构，一般为长锥形，即锥度变化小， 以形成一段长度较长、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、长锥形结构能加大球囊100和球囊400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度、血管撕裂或形成夹层的问题，同时增加球囊扩张充盈后的有效工作部长度。
请一并参阅图15和图16，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还包括用于连接推送导管310和滑动导管350的限位件360，推送导管310和滑动导管350大致平行设置，以及两球囊100和400的轴向平行。
具体的，如图15和图16所示，在本实施例中，滑动导管350还可以与推送导管310大致平行设置，且二者之间通过限位件360连接。限位件360可使得推送导管310与滑动导管350之间只会发生轴向相互运动，而不发生径向偏移。限位件360有多种实施方式：例如限位件360可以是设置在推送导管310与滑动导管350之间的套环或者环箍件，推送导管310与滑动导管350共同活动地穿设在套环或者环箍件内，从而限定二者之间只发生轴向移动。限位件360还可以是具有一定轴向长度的管状体，或者是将推送导管310与滑动导管350套设在一起的第三管体等形式。限位件360的具体形状及轴向长度不作限制，可根据推送导管310及滑动导管350的长度进行调整。例如，限位件360可以是圆型、椭圆型或者“8”字型，可以理解的是，为了减少药物涂层球囊导管的整体直径，推送导管310与滑动导管350的形状优选为相互配合形成完整的、无棱角的形状，例如圆形或椭圆形。
参见图15，在本实施例中，预扩张机构200包括与球囊100和球囊400一一对应的扩张套222和224。球囊100在预扩张前收容于其中一个扩张套222内且与扩张套222共同折翼并卷绕成柱体。球囊400在预扩张前收容于其中另一个 扩张套224内且与扩张套224共同折翼并卷绕成柱体。扩张套222和224的结构与扩张套220的结构基本相同，在此不再赘述。膨胀后的扩张套224的内径与扩张后的球囊400的直径一致或稍大于扩张后的球囊400的直径。
预扩张机构200包括与扩张套222和224一一对应的多个连接件242和244。在本实施例中，其中一个连接件242在球囊100预扩张后相对推送导管310沿轴向运动，以使球囊100裸露在扩张套222外，或是其中另一个连接件244在球囊400预扩张后相对滑动导管350沿轴向运动，以使球囊400裸露在扩张套224外。
具体地，扩张套224的近端设置连接管244。连接管244活动地套设于滑动导管350外，且沿轴向与滑动导管350相对运动。连接管244和滑动导管350套设在一起后，共同穿装在推送导管310的内腔中，并同时从推送导管310远端的侧壁的通孔中穿出。扩张套224与球囊400都可以相对于球囊100和扩张套222移动，以调整它们之间的相互位置关系。连接管244还可以选择丝状结构或者实心杆状结构等其他实施方式，在此不再赘述。
本实施例的药物涂层球囊导管，与现有技术相比，至少具有如下有益效果：
(1)扩张套套设在两个球囊的表面，与两个球囊共同推送至病变部位，之后扩张套扩张，可对病变部位进行有效的预扩张；
(2)扩张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；
(3)两个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；
(4)其中一个球囊可以设置为不规则形状，避免撕裂分叉位置的血管。
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预扩张机构，将预扩张机构与药物涂层球囊共同输送至病变部位，可有效保护药物涂层球囊免受血流冲刷，减少输送过程中的药物损失；预扩张机构对病变部位实现预扩张，使得药物涂层球囊可顺利进入病灶，增加了病变部位的血管内壁可与药物涂层球囊表面接触的面积，增加了药物涂层球囊扩张后转移至血管壁的药量，提 高了治疗效果；无需使用额外的预扩张球囊，降低手术复杂程度及手术成本，节约手术时间。
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，凡在本发明的精神和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 (25)

  1. 一种药物涂层球囊导管，包括：
    推送导管；
    第一球囊，固定地设置在所述推送导管上；及
    预扩张机构，包括：
    扩张套，用于在所述第一球囊未扩张前及预扩张时收容所述第一球囊，及
    连接件，连接所述扩张套，且在所述第一球囊预扩张后相对所述推送导管沿轴向运动，以使所述第一球囊裸露在所述扩张套外。
  2. 根据权利要求1所述的药物涂层球囊导管，其特征在于，所述第一球囊在预扩张完成后进行泄压，以使所述第一球囊与所述扩张套之间形成间隙。
  3. 根据权利要求2所述的药物涂层球囊导管，其特征在于，当所述第一球囊与扩张套之间的间隙小于预设阈值范围时，所述第一球囊收容于所述扩张套内；当所述第一球囊与扩张套之间的间隙大于预设阈值范围时，所述连接件相对所述推送导管朝远离所述第一球囊的一端运动，以使所述第一球囊裸露在所述扩张套外。
  4. 根据权利要求3所述的药物涂层球囊导管，其特征在于，所述预设阈值为0mm-10mm。
  5. 根据权利要求1所述的药物涂层球囊导管，其特征在于，在所述第一球囊预扩张前，所述扩张套套设在所述第一球囊外，且与所述第一球囊共同折翼并卷绕成第一柱体。
  6. 根据权利要求5所述的药物涂层球囊导管，其特征在于，所述第一球囊在预扩张前具有多个折翼。
  7. 根据权利要求1所述的药物涂层球囊导管，其特征在于，膨胀后的所述扩张套的内径与预扩张后的所述第一球囊的外径一致或者大于预扩张后的 第一球囊的外径。
  8. 根据权利要求1所述的药物涂层球囊导管，其特征在于，制成所述扩张套的材料的弹性模量小于制成所述第一球囊的材料的弹性模量。
  9. 根据权利要求1所述的药物涂层球囊导管，其特征在于，所述第一球囊的数量为一个或者多个，所述扩张套的数量等于或小于所述第一球囊的数量。
  10. 根据权利要求9所述的药物涂层球囊导管，其特征在于，当所述扩张套的数量为一个时，各所述第一球囊收纳于同一个所述扩张套内；当所述扩张套的数量为多个时，各所述第一球囊分别收纳于对应的扩张套中。
  11. 根据权利要求1所述的药物涂层球囊导管，其特征在于，所述推送导管沿轴向设置第一导丝腔及第一充盈腔，所述第一导丝腔贯通所述推送导管及所述第一球囊，所述第一充盈腔的远端与所述第一球囊的内部相连通。
  12. 根据权利要求11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，所述导管座设有与所述第一导丝腔连通的第一导丝端口及与所述第一充盈腔连通的第一充盈端口。
  13. 根据权利要求12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扩张套连接管的近端的手柄，所述手柄在轴向上与所述导管座相对运动。
  14. 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与所述推动导管滑动连接的滑动导管，所述滑动导管上设置有第二球囊，且所述第一球囊和所述第二球囊之间的相对位置可调节。
  15. 根据权利要求14所述的药物涂层球囊导管，其特征在于，所述滑动导管活动地穿设于所述推送导管内，且所述滑动导管的远端自所述推送导管的靠近远端的管壁穿出。
  16. 根据权利要求14所述的药物涂层球囊导管，其特征在于，所述滑动 导管的近端部分与所述推送导管的近端部分平行设置。
  17. 根据权利要求14所述的药物涂层球囊导管，其特征在于，所述第一球囊与所述第二球囊串联且同轴设置。
  18. 根据权利要求14所述的药物涂层球囊导管，其特征在于，所述第一球囊的轴向与所述第二球囊的轴向之间形成夹角。
  19. 根据权利要求14所述的药物涂层球囊导管，其特征在于，所述第一球囊和所述第二球囊在未扩张前均收容在所述扩张套内，且与所述扩张套共同折翼并卷绕成第二柱体。
  20. 根据权利要求19所述的药物涂层球囊导管，其特征在于，所述扩张套包括第一扩张套和第二扩张套，所述第一球囊在预扩张前收容于所述第一扩张套内，且与所述第一扩张套共同折翼并卷绕成第三柱体；所述第二球囊在预扩张前收容于第二扩张套内，且与所述第二扩张套共同折翼并卷绕成第四柱体。
  21. 根据权利要求20所述的药物涂层球囊导管，其特征在于，所述连接件包括与所述第一扩张套连接的第一连接件及与所述第二扩张套连接的第二连接件，所述第一连接件在所述第一球囊预扩张后相对所述推送导管沿轴向运动，以使所述第一球囊裸露在所述第一扩张套外；所述第二连接件在所述第二球囊预扩张后相对所述滑动导管沿轴向运动，以使所述第二球囊裸露在所述第二扩张套外。
  22. 根据权利要求20所述的药物涂层球囊导管，其特征在于，所述连接件与所述第一扩张套及第二扩张套连接，所述连接件在所述第一球囊和/或所述第二球囊预扩张后相对所述推送导管或所述滑动导管沿轴向运动，以使所述第一球囊裸露在所述第一扩张套外，且使所述第二球囊裸露在所述第二扩张套外。
  23. 根据权利要求20所述的药物涂层球囊导管，其特征在于，膨胀后的所述第二扩张套的内径与预扩张后的所述第二球囊的直径一致或大于预扩张 后的所述第二球囊的直径。
  24. 根据权利要求14所述的药物涂层球囊导管，其特征在于，所述第一球囊和所述第二球囊的外表面至少部分覆盖药物涂层。
  25. 根据权利要求1所述的药物涂层球囊导管，其特征在于，所述连接件选自空心管状结构、丝状结构或者实心杆状结构中的至少一种。
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