WO2020048257A1 - 一种间距可调式双球囊灌注导管及其使用方法 - Google Patents

一种间距可调式双球囊灌注导管及其使用方法 Download PDF

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Publication number
WO2020048257A1
WO2020048257A1 PCT/CN2019/098303 CN2019098303W WO2020048257A1 WO 2020048257 A1 WO2020048257 A1 WO 2020048257A1 CN 2019098303 W CN2019098303 W CN 2019098303W WO 2020048257 A1 WO2020048257 A1 WO 2020048257A1
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Prior art keywords
balloon
catheter
distal
adjustable
proximal
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PCT/CN2019/098303
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English (en)
French (fr)
Inventor
唐志
徐潮伟
李常青
冷德嵘
刘春俊
Original Assignee
南微医学科技股份有限公司
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Publication of WO2020048257A1 publication Critical patent/WO2020048257A1/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
    • 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
    • A61M25/1011—Multiple balloon catheters
    • A61M2025/1013—Multiple balloon catheters with concentrically mounted balloons, e.g. being independently inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • 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
    • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector

Definitions

  • the invention relates to the technical field of medical equipment for digestive medicine, in particular to a double-balloon perfusion catheter with adjustable spacing and a method for using the same.
  • Endoscopic submucosal dissection is a new treatment method that has appeared in recent years. It is mainly an endoscopic minimally invasive technique that uses various resection blades to perform submucosal dissection on lesions larger than 2 cm. This technique enables the complete removal of large lesions and provides accurate pathological diagnosis of the lesions. Compared with traditional surgery, ESD results in smaller wounds; patients can receive multiple treatments at multiple sites; doctors can obtain complete histopathological specimens for analysis; and better preserve the digestive tract on the basis of radical tumor treatment Physiological function has significantly improved the quality of life of patients after surgery. At present, it has become the preferred treatment method for early cancer and precancerous lesions of the digestive tract including the esophagus, and has good clinical application prospects.
  • the purpose of the present invention is to design an adjustable-spaced double-balloon perfusion catheter and a method of using the same, so that the drug perfusion becomes controllable, and effectively solves the inability to effectively cover a specific area when the perfusion hormone is given to the lesion site before ESD, and Fixed area length issues.
  • the invention provides an adjustable-spaced double-balloon perfusion catheter.
  • the adjustable-spaced double-balloon perfusion catheter includes a first catheter, a second catheter, a proximal balloon fixed at a distal end of the first catheter, and a fixation.
  • a distal balloon at the distal end of the second catheter; the first catheter has a liquid injection cavity, a first inflation cavity penetrating the first catheter, and a lumen passing through the second catheter;
  • the proximal balloon and the distal balloon can form a semi-closed structure in a human body cavity to lock the drug in a semi-closed treatment space.
  • the injection cavity may pass through the first catheter outside the second catheter and be distributed side by side with the first inflation cavity.
  • the distal end has an outlet at the distal end of the proximal balloon, the proximal end of the first catheter has an inflation joint and a fluid injection joint, and the proximal end of the second catheter has an inflation joint;
  • the fluid injection chamber may also Is penetrating through the second catheter and distributed side by side with the second inflation chamber, at this time, the distal end of the injection chamber has an outlet near the proximal end of the distal balloon, and the proximal end of the first catheter has inflation A joint, the proximal end of the second catheter has an inflatable joint and a fluid injection joint.
  • the distal ends of the first and second inflation chambers are located inside the proximal and distal balloons, respectively, and are inside the proximal and distal balloons, respectively. Communicate.
  • the adjustable-ballast double-balloon perfusion catheter is made of elastic material including silicone, natural rubber, and polyurethane.
  • the second catheter may further include a guide wire cavity.
  • the guide wire lumen can penetrate the entire second catheter.
  • the guide wire cavity may start at the proximal end of the distal balloon and end at the distal end of the second catheter.
  • a proximal end of the second catheter can also be connected with a guide wire joint.
  • the catheter is fixed on an endoscope and enters the human body, and the endoscope is adjusted to adjust the first catheter and the second catheter so that the diseased part is located on the endoscope.
  • the two balloons are filled with a medium through an inflatable joint to inflate the balloons to a diameter larger than the natural cavity of the human body, that is, fix the two balloons in the human body, and then The drug is released to the diseased site through the fluid injection joint.
  • the medium balloon in the balloon is withdrawn to shrink to the original size and then exit the endoscope channel.
  • the proximal balloon and the distal balloon are inflated to form a semi-closed structure in a lumen after inflating, and the medicine is confined within the semi-closed structure.
  • the balloon-filled medium may be a gas or a liquid.
  • the distal balloon can be fixed first, and then the first catheter can be adjusted so that the proximal balloon reaches the desired position, and then the proximal balloon is fixed. .
  • FIG. 1 is a schematic diagram of an adjustable-dual-balloon perfusion catheter in a human body.
  • FIG. 2 is a schematic structural diagram of an adjustable double balloon perfusion catheter.
  • FIG. 3A is an embodiment of an adjustable double balloon perfusion catheter.
  • FIG. 3B is a cross-sectional view of the adjustable double-balloon perfusion catheter shown in FIG. 3A.
  • 3C is a cross-sectional view of the adjustable double-balloon perfusion catheter C-C shown in FIG. 3B.
  • Fig. 3D is a cross-sectional view of the adjustable double balloon perfusion catheter D-D shown in Fig. 3B.
  • 3E is a cross-sectional view of the adjustable double-balloon perfusion catheter shown in FIG. 3B after a certain angle of rotation.
  • Fig. 3F is a cross-sectional view of the adjustable double balloon perfusion catheter C-C shown in Fig. 3E.
  • Fig. 3G is a cross-sectional view of the adjustable double balloon perfusion catheter D-D shown in Fig. 3E.
  • FIG. 4A is a cross-sectional view of another embodiment of an adjustable double-balloon perfusion catheter.
  • FIG. 4B is a cross-sectional view of the adjustable double-balloon perfusion catheter C-C shown in FIG. 4A.
  • Fig. 4C is a cross-sectional view of the adjustable double-balloon perfusion catheter D-D shown in Fig. 4A.
  • FIG. 4D is a cross-sectional view of the adjustable double-balloon perfusion catheter shown in FIG. 4A after a certain angle of rotation.
  • Fig. 4E is a cross-sectional view of the adjustable double-balloon perfusion catheter C-C shown in Fig. 4D.
  • Fig. 4F is a cross-sectional view of the adjustable double balloon perfusion catheter D-D shown in Fig. 4D.
  • Figure 5A is another embodiment of an adjustable double balloon perfusion catheter.
  • FIG. 5B is a cross-sectional view of the adjustable double-balloon perfusion catheter shown in FIG. 5A.
  • 5C is a cross-sectional view of the adjustable double-balloon perfusion catheter C-C shown in FIG. 5B.
  • Fig. 5D is a cross-sectional view of the adjustable double balloon perfusion catheter D-D shown in Fig. 5B.
  • 5E is a cross-sectional view of the adjustable double-balloon perfusion catheter shown in FIG. 5B after a certain angle of rotation.
  • Fig. 5F is a cross-sectional view of the adjustable double balloon perfusion catheter C-C shown in Fig. 5E.
  • 5G is a cross-sectional view of the adjustable double-balloon perfusion catheter D-D shown in FIG. 5E.
  • FIG. 6A is a cross-sectional view of another embodiment of an adjustable double-balloon perfusion catheter.
  • Fig. 6B is a cross-sectional view of the adjustable double balloon perfusion catheter C-C shown in Fig. 6A.
  • Fig. 6C is a cross-sectional view of the adjustable double-balloon perfusion catheter D-D shown in Fig. 6A.
  • FIG. 7A is a cross-sectional view of another embodiment of an adjustable double-balloon perfusion catheter.
  • Fig. 7B is a cross-sectional view of the adjustable double-balloon perfusion catheter C-C shown in Fig. 7A.
  • Fig. 7C is a cross-sectional view of the adjustable double-balloon perfusion catheter D-D shown in Fig. 7A.
  • the invention provides an adjustable-spaced double-balloon perfusion catheter.
  • the adjustable-spaced double-balloon perfusion catheter includes a first catheter, a second catheter, a proximal balloon fixed at a distal end of the first catheter, and a fixation.
  • the catheter has a second inflation chamber; the first catheter and the second catheter can be moved relatively to adjust the distance between the proximal balloon and the distal balloon.
  • the proximal balloon and the distal balloon can form a semi-closed structure in a human body cavity to lock the drug in a semi-closed treatment space;
  • the end has an outlet at the distal end of the proximal balloon.
  • the proximal balloon and the distal balloon are respectively disposed at both ends of a lesion site, and the proximal balloon and the distal balloon are filled with a medium and inflated to a size slightly larger than a natural cavity diameter of a human body, and then can be fixed.
  • a semi-closed structure is formed by two balloons and a human cavity containing a diseased part, which can be in fluid communication with the outside world through a liquid injection outlet.
  • the distal ends of the first and second inflation chambers are located inside the proximal and distal balloons, respectively, and are inside the proximal and distal balloons, respectively. Communicate.
  • the adjustable-ballast double-balloon perfusion catheter is an elastic material, including silicone, natural rubber, and polyurethane.
  • the second catheter may further include a guide wire cavity, which may penetrate the entire second catheter, or may start at the proximal end of the distal balloon and end at A distal end of the second catheter.
  • the injection cavity may pass through the first catheter outside the second catheter and be distributed side by side with the first inflation cavity.
  • the distal end has an outlet at the distal end of the proximal balloon, the proximal end of the first catheter has an inflation joint and a fluid injection joint, and the proximal end of the second catheter has an inflation joint;
  • the fluid injection chamber may also Is penetrating through the second catheter and distributed side by side with the second inflation chamber, at this time, the distal end of the injection chamber has an outlet near the proximal end of the distal balloon, and the proximal end of the first catheter has inflation A joint, the proximal end of the second catheter has an inflatable joint and a fluid injection joint; a balloon can be filled with a medium through the inflation joint, and a drug can be delivered to a diseased area through the fluid injection joint.
  • a proximal end of the second catheter can also be connected with a guide wire joint, and a guide wire can be placed in the adjustable-spacing double-balloon perfusion catheter through the guide wire joint.
  • the catheter is fixed on an endoscope and enters the human body, and the end of the lesion is adjusted to the proximal end by adjusting the first and second catheters
  • the two balloons are filled with a medium through an inflatable joint, respectively, so that the balloons expand to a diameter larger than the natural cavity of the human body.
  • the fluid joint releases the drug to the diseased area.
  • the medium in the balloon is withdrawn, and the balloon is contracted to its original size and exits the endoscopic channel.
  • the proximal balloon and the distal balloon are inflated to form a semi-closed structure in a lumen after being inflated, and the medicine is limited to the semi-closed structure;
  • the proximal balloon and the distal balloon are respectively disposed at both ends of the lesion, and the proximal balloon and the distal balloon are filled with a medium and inflated to a size slightly larger than the diameter of the natural cavity of the human body, and then can be fixed in the human body. Therefore, a semi-closed structure is formed by the two balloons and the human body cavity containing the diseased part, which can be in fluid communication with the outside world through the injection outlet.
  • the balloon-filled medium may be a gas or a liquid.
  • the distal balloon can be fixed first, and then the first catheter can be adjusted so that the proximal balloon reaches the desired position, and then the proximal balloon is fixed.
  • FIG. 1 to 7 it illustrates a catheter according to an embodiment of the present invention.
  • the adjustable-spacing dual-balloon perfusion catheter includes a first catheter, a second catheter, a proximal balloon, and a distal balloon.
  • the proximal balloon 3, 13, 23, 33, 43, 53 are fixed to the distal end of the first catheter 1, 11, 21, 31, 41, 51, and the distal balloon 4 , 14, 24, 34, 44, 54 are fixed to the distal end of the second catheter 2, 12, 22, 32, 42, 52, and the first catheter 1, 11, 21, 31, 41, 51 covers part of the second catheter On 2, 12, 22, 32, 42, 52, that is, the first conduit 1, 11, 21, 31, 41, 51 and the second conduit 2, 12, 22, 32, 42, 52 use the telescopic design.
  • FIG. 3A is an embodiment of an adjustable double-balloon perfusion catheter
  • FIG. 3B is a cross-sectional view of the adjustable double-balloon perfusion catheter shown in FIG. 3A
  • FIGS. 3C and 3D are respectively FIG. 3B
  • the cross-sectional views of the adjustable double-balloon perfusion catheter at CC and DD shown in FIG. 3E are cross-sectional views of the adjustable double-balloon perfusion catheter shown in FIG. 3B after a certain angle of rotation
  • FIGS. 3F and 3G are shown in FIG. 3E, respectively.
  • the first catheter 11 includes three channels separated from each other through the first catheter 11, which are a first inflation cavity 111, a liquid injection cavity 112, and a cavity passing through the second catheter 12, respectively; wherein the first inflation cavity 111 is at the proximal end
  • the inflatable joint 15 is connected, and the distal end is an inflatable outlet connected to the proximal balloon 13.
  • the inflatable outlet is arranged inside the proximal balloon 13 and passes through the first inflatable cavity 111 through the inflatable joint 15 from the inflatable outlet.
  • the proximal balloon 13 is inflated; a fluid injection connector 16 is connected to the proximal end of the fluid injection chamber 112, and the distal end is located at the distal end of the proximal balloon 13 and is provided with a fluid injection outlet 18 for discharging the medicine through which the medicine passes
  • the joint 16 reaches the diseased area from the injection outlet 18 through the injection cavity 112.
  • the second duct 12 passes through the cavity in the first duct 11 and passes through the first duct 11, and both ends thereof are located outside the two ends of the first duct 11, that is, the first duct 11 covers a part of the second duct 12;
  • the catheter 12 includes a second inflation chamber 121.
  • An inflation joint 17 is connected to the proximal end of the second inflation chamber 121.
  • An inflation outlet connected to the distal balloon 14 is connected to the distal end.
  • the cavity 121 inflates the distal balloon 14 from the inflation outlet.
  • the joint and the conduit are integrally formed.
  • the first conduit 11 and the second conduit 12 are made of a slightly flexible material, and may be a metal pipe or a plastic pipe.
  • the balloon uses elastic materials, including silicone, natural rubber, polyurethane, etc., which can prevent damage to the human body on the basis of achieving accurate plugging.
  • the first inflation cavity 111, the injection cavity 112, and the passage through the second catheter 12 may be lined up, but it is preferable that the first inflation cavity is as shown in Figs. 3C, 3D, and 3F, 3G.
  • the cavity 111, the injection cavity 112, and the channels passing through the second catheter 12 are in a triangular distribution, so that the diameter of the first catheter can be made as small as possible while ensuring that the inner diameters of the three channels are sufficiently large, thereby making it easier to enter the human body. Cavity, and effectively reduce the possibility of discomfort to the patient due to the excessive diameter of the tube.
  • the double-balloon perfusion catheter with adjustable pitch provided by the present invention when used, the double-balloon perfusion catheter is inserted into the forceps of the endoscope into the human body in an uninflated state of the balloon, and is first determined under the endoscope.
  • the site of the lesion that needs fluid injection then adjust the first catheter 1, 11, 21, 31, 41, 51 and the second catheter 2, 12, 22, 32, 42, 52 so that the lesion is in the proximal balloon 3, 13, Between 23, 33, 43, 53 and the distal balloon 4, 14, 24, 34, 44, 54 through the inflatable joints 15, 17, 35, 37 fill the two balloons with medium to expand the balloon beyond
  • the diameter of the human body's natural cavity is to fix the two balloons in the human body, and then release the drug to the diseased site through the fluid injection joints 16, 36.
  • the medium balloon in the balloon is withdrawn to shrink to the original size and exit the endoscope. aisle.
  • the balloon-filled medium may be a gas or a liquid, including nitrogen, air, water, and the like.
  • the specific operation can be to fix the distal balloon 4, 14, 24, 34, 44, 54 and then the proximal balloon 3, 13, 23, 33, 43, 53, and move the double-balloon perfusion catheter to the second balloon.
  • Catheters 2, 12, 22, 32, 42, 52 connect the distal balloon 4, 14, 24, 34, 44, 54 to the lesion, and the distal balloon 4, 14, 24, 34, 44, 54
  • the proximal end is located at the distal end of the lesion; then through the inflatable joints 15, 17, 35, 37 connected to the second catheter 2, 12, 22, 32, 42, 52 to the distal balloon 4, 14, 24, 34, 44,54 Inflate or infuse it to inflate the balloon to a diameter larger than the diameter of the human cavity, at this time the distal balloon 4,14,24,34,44,54 is fixed at the distal end of the lesion area; Then adjust the position of the first catheter 1, 11, 21, 31, 41, 51 relative to the second catheter 2, 12, 22, 32, 42, 52 so that the proximal balloon 3, 13, 23, 33, 43, The
  • the lesions to be treated with fluid injection are proximal balloon 3, 13, 23, 33, 43, 53 and distal balloon 4, 14, 24, 34, 44. , 54 through, with proximal balloon 3, 13, 23, 3 3,43,53 Inflatable joint 15 connected to the proximal balloon 3,13,23,33,43,53 Inflate or infuse the balloon to a diameter larger than the diameter of the human lumen, the proximal balloon 3,13,23,33,43,53 are fixed at the proximal end of the diseased area; the drug or liquid is passed from the injection connector 16,36 connected to the first catheter 1,11,21,31,41,51.
  • the endoscopic forceps can be withdrawn. Due to the presence of the proximal balloon 3,13,23,33,43,53 and the distal balloon 4,14,24,34,44,54, the drug is locked between the two balloons, so the patient is sitting Both the standing and standing states can be treated.
  • the double-balloon perfusion catheter of the present invention can also be used when the proximal balloon 3, 13, 23, 33, 43, 53 is fixed first, and then by adjusting the second catheter 2, 12, 22, 32, 42, 52 Re-fixation of the distal balloon 4, 14, 24, 34, 44, 54 is done.
  • a telescoping design is adopted between the first catheter 1, 11, 21, 31, 41, 51 and the second catheter 2, 12, 22, 32, 42, 52, and a distal end of each of the two catheters is fixed with a ball. Balloon, only the two catheters need to be adjusted to adjust the balloon spacing, and the function of injecting liquid to achieve perfusion between the two balloons can be achieved, which is effective and safer.
  • the adjustable-spacing double-balloon perfusion catheter is suitable for a biopsy channel with a diameter greater than 2.8 mm.
  • the minimum biopsy channel size is generally 2.8mm.
  • the adjustable diameter double-balloon perfusion catheter of the present invention has a working diameter of less than 2.8mm, which can be used with endoscopes with biopsy channels of 2.8mm and above Mirror, suitable for almost all biopsy channels.
  • the injection cavity 412 may not be in the first conduit 41, but in the second conduit 42, penetrating the second conduit 42 and inflating the second
  • the cavities 421 are arranged side by side.
  • the distal end of the injection cavity 412 has an injection outlet 48 near the proximal end of the distal balloon 44.
  • the infusion injection port 48 is an incision in the side wall of the second catheter 42 between the proximal balloon 43 and the distal balloon 44.
  • the second catheters 22, 32 may further include guide wire cavities 291, 391, wherein the entire product can be guided to Site of guide wire 29.
  • the guidewire lumen 291 may be located only at the distal end of the second catheter 22 as shown in FIGS. 4A-4F, that is, it starts at the proximal end of the distal balloon 24 and terminates at the distal end of the second catheter 22, or it may be as shown in FIG. 5A.
  • the -5G is shown throughout the entire second catheter 32, starting at the proximal end of the second catheter 32 and terminating at the distal end of the second catheter 32.
  • Fig. 4A is a cross-sectional view of another embodiment of the adjustable double-balloon perfusion catheter
  • Figs. 4B and 4C are the CC and DD of the adjustable double-balloon perfusion catheter shown in Fig. 4A, respectively.
  • 4D is a cross-sectional view of the adjustable double-balloon perfusion catheter shown in FIG. 4A after a certain angle of rotation
  • FIGS. 4E and 4F are the CC and DD positions of the adjustable double-balloon perfusion catheter shown in FIG. 4D, respectively.
  • the guide wire lumen 291 is only at the distal end of the second catheter 22.
  • the section of the second catheter 22 from the proximal end to the proximal end of the distal balloon 24 is a single-lumen structure.
  • the second catheter 22 has a dual-lumen structure and includes a guide wire cavity 291 in addition to the second inflation cavity 221.
  • the guide wire 29 can be started from the proximal end of the distal balloon 24 and guided through the guide wire cavity 291.
  • the guide wire 29 is inserted into a predetermined position in the human body along the endoscopic biopsy channel, and then The guide wire is inserted into the guide wire cavity 291 from the end of the distal catheter of the distal balloon 24 of the instrument, penetrates into the endoscopic biopsy channel, and then the guide wire 29 exits the guide wire cavity 291 from the proximal end of the distal balloon 24.
  • the guide wire lumen starts and ends at the front and rear ends of the distal balloon 24, and the guide wire 29 guides a short distance. At this point, the entire instrument is pushed to the desired location under the guidance of the guide wire.
  • Figs. 5A-5G Fig. 5A is another embodiment of the adjustable double-balloon perfusion catheter, and Fig.
  • FIG. 5B is a cross-sectional view of the adjustable double-balloon perfusion catheter shown in Fig. 5A.
  • Figs. 5C and 5D are respectively 5B is a cross-sectional view of the adjustable double-balloon perfusion catheter at CC and DD
  • FIG. 5E is a cross-sectional view of the adjustable double-balloon perfusion catheter shown in FIG. 5B after a certain angle of rotation
  • FIGS. 5F and 5G are diagrams respectively 5E cross-sectional view of the adjustable double balloon perfusion catheter at CC and DD.
  • the guide wire lumen 391 penetrates the entire second catheter 32, and two joints are connected to the proximal end of the second catheter 32, namely an inflatable joint 37 and a guide wire joint 39; the inflatable joint 37 is connected to the inflatable chamber in the second catheter 32, The distal end of the inflation cavity is an inflation outlet connected to the distal balloon 34.
  • the inflation outlet is disposed inside the distal balloon 34 and passes from the inflation outlet 37 to the distal end through the inflation joint 37 through the second inflation cavity 321.
  • the balloon 34 is inflated;
  • the guide wire connector 39 is connected to the guide wire cavity 391, the distal end of the guide wire cavity 391 is located at the distal end of the second catheter 32 as an outlet, and the guide wire 29 is disposed in the guide wire cavity 391.
  • the guidewire lumen starts from the end of the catheter at the distal end of the entire instrument, that is, the distal end of the distal balloon 34, and extends to the proximal guidewire connector 39 of the entire instrument.
  • the guide wire 29 is placed in a predetermined position in the human body along the endoscope biopsy channel, and then the guide wire 29 is left at the end of the body and inserted into the guide wire cavity 391 from the distal end of the entire instrument, and then from the proximal guide wire connector. 39 penetrates the guide wire cavity 391, and the instrument is pushed to a predetermined position along the guide wire.
  • the guide wire 29 penetrates the entire interior of the instrument, and the guide distance is longer.
  • the injection cavity 512 is located in the second conduit 52, penetrates the second conduit 52, and is arranged side by side with the second inflation cavity 521. At this time, the injection The distal end of the cavity 512 has a fluid injection outlet 58 near the proximal end of the distal balloon 54.
  • the infusion injection port 58 is an incision in the side wall of the second catheter 52 between the proximal balloon 53 and the distal balloon 54.

Abstract

一种间距可调式双球囊灌注导管，包括第一导管（1，11，21，31，41，51）、第二导管（2，12，22，32，42，52）、固定在第一导管（1，11，21，31，41，51）远端的近端球囊（3，13，23，33，43，53）和固定在第二导管（2，12，22，32，42，52）远端的远端球囊（4，14，24，34，44，54）；第一导管（1，11，21，31，41，51）内有注液腔（112，212，312，412，512）、贯穿第一导管（1，11，21，31，41，51）的充气腔（111，211，311，411，511）和通过第二导管（2，12，22，32，42，52）的腔道，第二导管（2，12，22，32，42，52）内有充气腔（121，221，321，421，521），腔道沿导管同轴方向延伸；近端球囊（3，13，23，33，43，53）和远端球囊（4，14，24，34，44，54）间的距离可以通过令第一导管（1，11，21，31，41，51）和第二导管（2，12，22，32，42，52）相对移动来调节。

Description

一种间距可调式双球囊灌注导管及其使用方法 技术领域
本发明涉及消化内科医疗器械技术领域，特别是一种间距可调式双球囊灌注导管及其使用方法。
背景技术
内镜黏膜下剥离术(Endoscopic submucosal dissection,ESD)是近年来出现的一项新的治疗手段，主要是利用各种电切刀对大于2cm的病变进行黏膜下剥离的内镜微创技术。这一技术实现了较大病变的整块切除，为病变提供了准确的病理诊断分期。与传统外科手术相比，ESD造成的创口较小；患者可接受多个部位的多次治疗；医生能得到完整的组织病理标本以供分析；在根治肿瘤的基础上，较好地保留消化道生理功能，明显改善了患者术后生活质量，目前已成为了包括食管在内的消化道早期癌及癌前病变的首选治疗方法，具有良好的临床应用前景。
但由于ESD切除粘膜面积大，术后常见的并发症是ESD术后再狭窄，为了解决这一难题在临床实际ESD术前给予病变部位灌注激素。因为液体在肠道活胆道内会随意流动，无法固定在所需区域，所以目前通常患者只能在平躺状态下将激素液体注入患者自然腔道的病变部位，缺点是注入量大，激素液体流动不能有效覆盖病变部位，给临床实际操作带来困难。
因此一种能将液体药物有效覆盖特定区域，且不固定区域长度的医疗器械的迫切需要的。
发明内容
本发明的目的，是设计一种间距可调式双球囊灌注导管及其使用方法，使得药物灌注变得可控，有效的解决ESD术前给予病变部位灌注激素时不能有效覆盖特定区域，且不固定区域长度的问题。
本发明提供了一种间距可调式双球囊灌注导管，所述间距可调式双球囊灌注导管包括第一导管、第二导管、固定在所述第一导管远端 的近端球囊和固定在所述第二导管远端的远端球囊；所述第一导管内有注液腔、贯穿所述第一导管的第一充气腔和通过所述第二导管的腔道，所述第二导管内有第二充气腔；所述第一导管和第二导管可以相对移动来调节所述近端球囊和所述远端球囊间的距离。
本发明的间距可调式双球囊灌注导管，所述近端球囊和远端球囊在人体腔道内可以形成半封闭结构，将药物锁定在半封闭治疗空间内。
本发明的间距可调式双球囊灌注导管，所述注液腔可以是在所述第二导管外贯穿所述第一导管，与第一充气腔并排分布，此时所述注液腔的远端具有一个位于所述近端球囊远端的出口，所述第一导管的近端具有充气接头和注液接头，所述第二导管的近端具有充气接头；所述注液腔也可以是贯穿所述第二导管，与第二充气腔并排分布，此时所述注液腔的远端具有一个靠近所述远端球囊近端的出口，所述第一导管的近端具有充气接头，所述第二导管的近端具有充气接头和注液接头。
本发明的间距可调式双球囊灌注导管，所述第一和第二充气腔的远端分别位于所述近端和远端球囊内部，且分别与所述近端和远端球囊内部相通。
本发明的间距可调式双球囊灌注导管，所述球囊为弹性材料包括硅胶、天然橡胶和聚氨酯。
本发明的间距可调式双球囊灌注导管，所述第二导管内还可以包含导丝腔。
本发明的间距可调式双球囊灌注导管，所述导丝腔可以贯穿整个所述第二导管。
本发明的间距可调式双球囊灌注导管，所述导丝腔可以起始于所述远端球囊的近端，结束于所述第二导管的远端。
本发明的间距可调式双球囊灌注导管，所述第二导管的近端还可以连接导丝接头。
本发明的间距可调式双球囊灌注导管的使用方法，将所述导管固定在内窥镜上进入人体，在内镜作用下通过调节所述第一导管和第二导管使得病变部位处于所述近端球囊和所述远端球囊之间，通过充气 接头分别向两个球囊内填充介质使得球囊膨胀至超过人体自然腔道的直径，即将两个球囊固定在人体内，再通过注液接头向病变部位释放药物，完成后抽出球囊内的介质球囊收缩至原始大小后退出内窥镜通道。
本发明的间距可调式双球囊灌注导管的使用方法，所述近端球囊和远端球囊膨胀后在腔道中形成半封闭结构，将药物限定在所述半封闭结构内。
本发明的间距可调式双球囊灌注导管的使用方法，所述填充球囊的介质可以为气体或者液体。
本发明的间距可调式双球囊灌注导管的使用方法，可以先固定所述远端球囊后再调节所述第一导管使得所述近端球囊到达所需位置后再固定近端球囊。
附图说明：
图1是间距可调式双球囊灌注导管在人体内的示意图。
图2是可调式双球囊灌注导管的结构示意图。
图3A是可调式双球囊灌注导管的一个实施例。
图3B是图3A所示的可调式双球囊灌注导管的剖视图。
图3C是图3B所示的可调式双球囊灌注导管C-C处的截面图。
图3D是图3B所示的可调式双球囊灌注导管D-D处的截面图。
图3E是3B所示的可调式双球囊灌注导管旋转一定角度后的的剖视图。
图3F是图3E所示的可调式双球囊灌注导管C-C处的截面图。
图3G是图3E所示的可调式双球囊灌注导管D-D处的截面图。
图4A是可调式双球囊灌注导管的另一种实施例的剖视图。
图4B是图4A所示的可调式双球囊灌注导管C-C处的截面图。
图4C是图4A所示的可调式双球囊灌注导管D-D处的截面图。
图4D是图4A所示的可调式双球囊灌注导管旋转一定角度后的剖视图。
图4E是图4D所示的可调式双球囊灌注导管C-C处的截面图。
图4F是图4D所示的可调式双球囊灌注导管D-D处的截面图。
图5A是可调式双球囊灌注导管的另一种实施例。
图5B是图5A所示的可调式双球囊灌注导管的剖视图。
图5C是图5B所示的可调式双球囊灌注导管C-C处的截面图。
图5D是图5B所示的可调式双球囊灌注导管D-D处的截面图。
图5E是图5B所示的可调式双球囊灌注导管旋转一定角度后的剖视图。
图5F是图5E所示的可调式双球囊灌注导管C-C处的截面图。
图5G是图5E所示的可调式双球囊灌注导管D-D处的截面图。
图6A是可调式双球囊灌注导管的另一种实施例的剖视图。
图6B是图6A所示的可调式双球囊灌注导管C-C处的截面图。
图6C是图6A所示的可调式双球囊灌注导管D-D处的截面图。
图7A是可调式双球囊灌注导管的另一种实施例的剖视图。
图7B是图7A所示的可调式双球囊灌注导管C-C处的截面图。
图7C是图7A所示的可调式双球囊灌注导管D-D处的截面图。
附图标号说明
第一导管1、11、21、31、41、51，第二导管2、12、22、32、42、52，近端球囊3、13、23、33、43、53，远端球囊4、14、24、34、44、54，第一充气腔111、211、311、411、511，注液腔112、212、312、412、512，充气接头15、17、35、37，注液接头16、36，注液出口18、28、38、48、58，第二充气腔121、221、321、421、521，导丝29，导丝腔291、391、591。
具体实施方式
以下结合附图对本发明技术方案进行详细说明。应当理解，此处所描述的具体实施方式仅用以解释本发明，并不用于限定本发明。本申请的范围并不受这些实施方式的限定，乃以申请专利的范围为准。而为提供更清楚的描述及使熟悉该项技艺者能理解本申请的申请内容，图示内各部分并不一定依照其相对的尺寸而绘图，某些尺寸与其他相关尺度的比例会被凸显而显得夸张，且不相关或不重要的细节部分亦未完全绘出，以求图示的简洁。
本发明提供了一种间距可调式双球囊灌注导管，所述间距可调式 双球囊灌注导管包括第一导管、第二导管、固定在所述第一导管远端的近端球囊和固定在所述第二导管远端的远端球囊；所述第一导管内有注液腔贯穿所述第一导管的第一充气腔和通过所述第二导管的腔道，所述第二导管内有第二充气腔；所述第一导管和第二导管可以相对移动来调节所述近端球囊和所述远端球囊间的距离。
本发明的间距可调式双球囊灌注导管，所述近端球囊和远端球囊在人体腔道内可以形成半封闭结构，将药物锁定在半封闭治疗空间内；所述注液腔的远端具有一个位于所述近端球囊远端的出口。具体为所述近端球囊和远端球囊分别设置在病变部位的两端，所述近端球囊和远端球囊被填充介质后膨胀至略大于人体自然腔道直径后即可固定在人体内，从而由两个球囊以及包含病变部位的人体腔道形成一个半封闭结构，可以通过注液出口和外界流体连通。
本发明的间距可调式双球囊灌注导管，所述第一和第二充气腔的远端分别位于所述近端和远端球囊内部，且分别与所述近端和远端球囊内部相通。
本发明的间距可调式双球囊灌注导管，所述球囊为弹性材料包括硅胶、天然橡胶、聚氨酯等。
本发明的间距可调式双球囊灌注导管，第二导管内还可以包含导丝腔，导丝腔可以贯穿整个第二导管，也可以起始于所述远端球囊的近端，结束于所述第二导管的远端。
本发明的间距可调式双球囊灌注导管，所述注液腔可以是在所述第二导管外贯穿所述第一导管，与第一充气腔并排分布，此时所述注液腔的远端具有一个位于所述近端球囊远端的出口，所述第一导管的近端具有充气接头和注液接头，所述第二导管的近端具有充气接头；所述注液腔也可以是贯穿所述第二导管，与第二充气腔并排分布，此时所述注液腔的远端具有一个靠近所述远端球囊近端的出口，所述第一导管的近端具有充气接头，所述第二导管的近端具有充气接头和注液接头；通过所述充气接头可以向球囊填充介质，通过所述注液接头可以向病变区域输送药物。
本发明的间距可调式双球囊灌注导管，第二导管的近端还可以连 接导丝接头，通过所述导丝接头可以向所述间距可调式双球囊灌注导管内放置导丝。
本发明的间距可调式双球囊灌注导管的使用方法，将所述导管固定在内窥镜上进入人体，在内镜作用下通过调节第一导管和第二导管使得病变部位处于所述近端球囊和所述远端球囊之间，通过充气接头分别向两个球囊内填充介质使得球囊膨胀至超过人体自然腔道的直径，即将两个球囊固定在人体内，再通过注液接头向病变部位释放药物，完成后抽出球囊内的介质，球囊收缩至原始大小后退出内窥镜通道。
本发明的间距可调式双球囊灌注导管的使用方法，所述近端球囊和远端球囊膨胀后在腔道中形成半封闭结构，将药物限定在所述半封闭结构内；具体为所述近端球囊和远端球囊分别设置在病变部位的两端，所述近端球囊和远端球囊被填充介质后膨胀至略大于人体自然腔道直径后即可固定在人体内，从而由两个球囊以及包含病变部位的人体腔道形成一个半封闭结构，可以通过注液出口和外界流体连通。
本发明的间距可调式双球囊灌注导管的使用方法，所述填充球囊的介质可以为气体或者液体。
本发明的间距可调式双球囊灌注导管的使用方法，可以先固定远端球囊后再调节第一导管使得近端球囊到达所需位置后再固定近端球囊。
如图1至图7所示，其示意了本发明实施方式的导管。
在本发明的非限制性实施方式中，间距可调式双球囊灌注导管包括第一导管、第二导管、近端球囊和远端球囊。如图1至图7所示，其中近端球囊3，13，23，33，43，53固定在第一导管1，11，21，31，41，51的远端，远端球囊4，14，24，34，44，54固定在第二导管2，12，22，32，42，52的远端，第一导管1，11，21，31，41，51覆盖在部分第二导管2，12，22，32，42，52上，即第一导管1，11，21，31，41，51和第二导管2，12，22，32，42，52采用套叠设计。
如图3A-3G所示，其中图3A是可调式双球囊灌注导管的一个实施例，图3B是图3A所示的可调式双球囊灌注导管的剖视图，图3C和3D分别是图3B所示的可调式双球囊灌注导管C-C处和D-D处的截面图；图3E是3B所示的可调式双球囊灌注导管旋转一定角度后的剖视图，图3F和3G分别是图3E所示的可调式双球囊灌注导管C-C处和D-D处的截面图。第一导管11内包含贯穿第一导管11的彼此分离的三个腔道，分别为第一充气腔111、注液腔112和通过第二导管12的腔道；其中第一充气腔111近端连接有充气接头15，远端为一个与近端球囊13相连的充气出口，该充气出口设置在近端球囊13内部，通过所述充气接头15经过第一充气腔111从所述充气出口向近端球囊13充气；注液腔112近端连接有注液接头16，远端位于近端球囊13的远端且设有一个排出药物的注液出口18，药物通过所述注液接头16经过注液腔112从所述注液出口18到达病变区域。第二导管12通过第一导管11内的腔道穿过第一导管11，其两端均位于第一导管11的两端外侧，即第一导管11覆盖在部分第二导管12外；第二导管12内包括第二充气腔121，所述第二充气腔121近端连接有充气接头17，远端为一个与远端球囊14相连的充气出口，通过所述充气接头17经过第二充气腔121从所述充气出口向远端球囊14充气。本发明中的所述接头和导管均为一体成型，所述第一导管11和第二导管12为略带柔性的材质制成，可以是金属管或塑料管等。球囊采用弹性材料，包括硅胶、天然橡胶、聚氨酯等，可以在达到精准堵漏的基础上避免对人体的伤害。
本发明中的第一充气腔111、注液腔112和通过第二导管12的腔道可以为一字排开，但优选的为如图3C、3D和图3F、3G所示，第一充气腔111、注液腔112和通过第二导管12的腔道呈三角形分布，使得在保证三个腔道内径足够大的前提下能够使第一导管的直径尽可能小，从而更容易进入人体的腔道，并有效减少因管径过粗对患者带来不适感的可能性。
本发明提供的间距可调式双球囊灌注导管如图1所示在使用时，双球囊灌注导管以球囊未充气的状态插入到内窥镜的钳道内进入人 体，首先在内镜下确定需要注液的病变部位，然后调节第一导管1，11，21，31，41，51和第二导管2，12，22，32，42，52使得病变部位处于近端球囊3，13，23，33，43，53和远端球囊4，14，24，34，44，54之间，通过充气接头15，17，35，37向两个球囊内填充介质使得球囊膨胀至超过人体自然腔道的直径，即将两个球囊固定在人体内，再通过注液接头16，36向病变部位释放药物，完成后抽出球囊内的介质球囊收缩至原始大小后退出内窥镜通道。
所述填充球囊的介质可以为气体或液体，包括氮气、空气、水等。
具体的操作可以为先固定远端球囊4，14，24，34，44，54再固定近端球囊3，13，23，33，43，53，移动双球囊灌注导管使得与第二导管2，12，22，32，42，52连接的远端球囊4，14，24，34，44，54越过病变位置，且远端球囊4，14，24，34，44，54的近端位于病变位置的远端；然后通过与第二导管2，12，22，32，42，52连接的充气接头15，17，35，37向远端球囊4，14，24，34，44，54充气或注液使其膨胀至球囊的直径大于所在人体腔道的直径，此时远端球囊4，14，24，34，44，54即固定在了病变区域的远端；接着调整第一导管1，11，21，31，41，51相对于第二导管2，12，22，32，42，52的位置，使得近端球囊3，13，23，33，43，53的远端位于病变区域的近端，此时需要注液治疗的病变部位处于近端球囊3，13，23，33，43，53和远端球囊4，14，24，34，44，54之间，通过与近端球囊3，13，23，33，43，53连接的充气接头15向近端球囊3，13，23，33，43，53充气或注液使其膨胀至球囊的直径大于所在人体腔道的直径，近端球囊3，13，23，33，43，53即固定在了病变区域的近端；药物或液体通过与第一导管1，11，21，31，41，51相连的注液接头16，36从近端球囊3，13，23，33，43，53的末端的注液出口18，28，38，48，58进入人体；保持一段时间，确保药物被人体吸收后抽出球囊内的介质使球囊自动收缩后即可退出内窥镜钳道。因近端球囊3，13，23，33，43，53和远端球囊4，14，24，34，44，54的存在，药物被锁定在两个球囊之间，所以患者持坐着或站着的状态都可接受治疗；同时因为两个球囊限制药物的流动，因此没 有药物的损失发生，所需的药物注入量较小；并且在坐着或站着的状态下，药物受重力的影响，相对于平躺的状态，更少量的药物就能有效的覆盖近端球囊3，13，23，33，43，53和远端球囊4，14，24，34，44，54之间的所有病变部位。
本发明的双球囊灌注导管在使用时还可以是先固定近端球囊3，13，23，33，43，53后在通过调节第二导管2，12，22，32，42，52从而再固定远端球囊4，14，24，34，44，54的方式完成。
本发明中第一导管1，11，21，31，41，51和第二导管2，12，22，32，42，52之间采用套叠设计，且两个导管的远端各自固定一个球囊，仅需调整两个导管就可以实现调节球囊间距，还可实现利用注入液体实现两球囊间灌注的功能，操作有效且更安全。
本发明的间距可调式双球囊灌注导管适用于直径大于2.8mm的活检通道。常规的胃镜、肠镜等内窥镜，最小活检通道尺寸一般为2.8mm，本发明的间距可调式双球囊灌注导管的工作直径小于2.8mm，即可以配合活检通道2.8mm及以上的内窥镜，适用于几乎所有的活检通道。
与图3A-3G不同的，如图6A-6C所示，注液腔412还可以不在第一导管41内，而是在第二导管42内，贯穿所述第二导管42，与第二充气腔421并排分布，此时所述注液腔412的远端具有一个靠近所述远端球囊44近端的注液出口48。优选的，注液出口48是第二导管42在近端球囊43和远端球囊44之间侧壁上的一个切口。
在本发明的非限制性实施例中，如图4A-4F和图5A-5G所示，第二导管22、32内还可以包括导丝腔291、391，其中可通过引导整个产品至所需部位的导丝29。导丝腔291可以如图4A-4F所示仅位于第二导管22的远端，即起始于远端球囊24的近端，终止于第二导管22的远端，也可以如图5A-5G所示贯穿整个第二导管32，即起始于第二导管32的近端，终止于第二导管32的远端。
如图4A-4F所示，其中图4A是可调式双球囊灌注导管的另一种实施例的剖视图，图4B和4C分别是图4A所示的可调式双球囊灌注导管C-C处和D-D处的截面图，图4D是图4A所示的可调式双球囊 灌注导管旋转一定角度后的剖视图，图4E和4F分别是图4D所示的可调式双球囊灌注导管C-C处和D-D处的截面图。导丝腔291仅在第二导管22的远端。此时第二导管22从其近端开始至远端球囊24近端截止这一段为单腔结构，第二导管22内只有一个充气腔221；从远端球囊24的近端开始到第二导管22的远端结束，第二导管22为双腔结构，除了第二充气腔221之外，还包括导丝腔291。导丝29可从远端球囊24的近端开始，穿过导丝腔291起到引导作用，在使用过程中，导丝29延内窥镜活检通道预先插入到人体内的预定位置，然后将导丝从器械远端球囊24的远端导管端面进入导丝腔291，穿入内窥镜活检通道，然后导丝29从远端球囊24的近端穿出导丝腔291。导丝腔道的起、止于远端球囊24的前、后端，导丝29引导距离短。这时，整个器械就会在导丝引导下被推送到所需部位。如图5A-5G所示，其中图5A是可调式双球囊灌注导管的另一种实施例，图5B是图5A所示的可调式双球囊灌注导管的剖视图，图5C和5D分别是图5B所示的可调式双球囊灌注导管C-C处和D-D处的截面图，图5E是图5B所示的可调式双球囊灌注导管旋转一定角度后的剖视图，图5F和5G分别是图5E所示的可调式双球囊灌注导管C-C处和D-D处的截面图。导丝腔391贯穿整个第二导管32，在第二导管32的近端连接有两个接头，分别为充气接头37和导丝接头39；充气接头37与第二导管32内的充气腔相连，充气腔的远端为一个与远端球囊34相连的充气出口，该充气出口设置在远端球囊34内部，通过所述充气接头37经过第二充气腔321从所述充气出口向远端球囊34充气；导丝接头39与导丝腔391相连，导丝腔391的远端位于第二导管32的远端末端为一个出口，导丝29设置在过导丝腔391内。因为导丝腔道是从整个器械的远端即远端球囊34远端的导管端面开始，延伸到整个器械的近端导丝接头39处。在使用时，导丝29延内窥镜活检通道预先放置在人体内预定位置，然后将导丝29留在体外一端从整个器械的远端插入导丝腔391，然后再从近端导丝接头39穿出导丝腔391，器械会沿着导丝被推送到预定位置。相较于图4A所示的可调式双球囊灌注导管，因为导丝29贯穿整个器械内部，引导的 距离更长。
与图5A-5G不同的，如图7A-7C所示，注液腔512在第二导管52内，贯穿所述第二导管52，与第二充气腔521并排分布，此时所述注液腔512的远端具有一个靠近所述远端球囊54近端的注液出口58。优选的，注液出口58是第二导管52在近端球囊53和远端球囊54之间侧壁上的一个切口。
以上所述仅是本发明的优选实施例而已，并非对本发明做任何形式上的限制，虽然本发明已以优选实施例揭露如上，然而并非用以限定本发明，任何熟悉本专业的技术人员，在不脱离本发明技术方案的范围内，当可利用上述揭示的技术内容作出些许更动或修饰为等同变化的等效实施例，但凡是未脱离本发明技术方案的内容，依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与修饰，均仍属于本发明技术方案的范围内。

Claims (18)

  1. 一种间距可调式双球囊灌注导管，其特征在于，所述间距可调式双球囊灌注导管包括第一导管、第二导管、固定在所述第一导管远端的近端球囊和固定在所述第二导管远端的远端球囊；
    所述第一导管内有注液腔、贯穿所述第一导管的第一充气腔和通过所述第二导管的腔道，所述第二导管内有第二充气腔；所述第一导管和第二导管可以相对移动来调节所述近端球囊和所述远端球囊间的距离。
  2. 根据权利要求1所述的间距可调式双球囊灌注导管，其特征在于，所述近端球囊和远端球囊在人体腔道内可以形成半封闭结构，将药物锁定在半封闭治疗空间内。
  3. 根据权利要求1所述的间距可调式双球囊灌注导管，其特征在于，所述注液腔在所述第二导管外贯穿所述第一导管，与第一充气腔并排分布。
  4. 根据权利要求1所述的间距可调式双球囊灌注导管，其特征在于，所述注液腔贯穿所述第二导管，与第二充气腔并排分布。
  5. 根据权利要求3所述的间距可调式双球囊灌注导管，其特征在于，所述注液腔的远端具有一个位于所述近端球囊远端的出口。
  6. 根据权利要求4所述的间距可调式双球囊灌注导管，其特征在于，所述注液腔的远端具有一个靠近所述远端球囊近端的出口。
  7. 根据权利要求1所述的间距可调式双球囊灌注导管，其特征在于，所述第一和第二充气腔的远端分别位于所述近端和远端球囊内部，且分别与所述近端和远端球囊内部相通。
  8. 根据权利要求1所述的间距可调式双球囊灌注导管，其特征在于，所述球囊为弹性材料包括硅胶、天然橡胶和聚氨酯。
  9. 根据权利要求1所述的间距可调式双球囊灌注导管，其特征在于，所述第二导管内还可以包含导丝腔。
  10. 根据权利要求9所述的间距可调式双球囊灌注导管，其特征在于，所述导丝腔可以贯穿整个所述第二导管。
  11. 根据权利要求9所述的间距可调式双球囊灌注导管，其特征在于，所述导丝腔可以起始于所述远端球囊的近端，结束于所述第二导管的远端。
  12. 根据权利要求3所述的间距可调式双球囊灌注导管，其特征在于，所述第一导管的近端具有充气接头和注液接头，所述第二导管的近端具有充气接头。
  13. 根据权利要求4所述的间距可调式双球囊灌注导管，其特征在于，所述第一导管的近端具有充气接头，所述第二导管的近端具有充气接头和注液接头。
  14. 根据权利要求9所述的间距可调式双球囊灌注导管，其特征在于，所述第二导管的近端还可以连接导丝接头。
  15. 一种权利要求1所述间距可调式双球囊灌注导管的使用方法，其特征在于，将所述导管固定在内窥镜上进入人体，在内镜作用下通过调节所述第一导管和第二导管使得病变部位处于所述近端球囊和所述远端球囊之间，通过充气接头分别向两个球囊内填充介质使得球囊膨胀至超过人体自然腔道的直径，即将两个球囊固定在人体内，再通过注液接头向病变部位释放药物，完成后抽出球囊内的介质球囊收缩至原始大小后退出内窥镜通道。
  16. 根据权利要求15所述的方法，其特征在于，所述近端球囊和远端球囊膨胀后在腔道中形成半封闭结构，将药物限定在所述半封闭结构内。
  17. 根据权利要求15所述的方法，其特征在于，所述填充球囊的介质可以为气体或者液体。
  18. 根据权利要求15所述的方法，其特征在于，可以先固定所述远端球囊后再调节所述第一导管使得所述近端球囊到达所需位置后再固定所述近端球囊。
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