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WO2014165751A1 - Appareil à ballonnet pour l'administration de médicaments - Google Patents

Appareil à ballonnet pour l'administration de médicaments Download PDF

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Publication number
WO2014165751A1
WO2014165751A1 PCT/US2014/032964 US2014032964W WO2014165751A1 WO 2014165751 A1 WO2014165751 A1 WO 2014165751A1 US 2014032964 W US2014032964 W US 2014032964W WO 2014165751 A1 WO2014165751 A1 WO 2014165751A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
drug delivery
lumen
drag
drug
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/US2014/032964
Other languages
English (en)
Inventor
Patrick K. KELLY
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.)
Sanford Health
Original Assignee
Sanford Health
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 Sanford Health filed Critical Sanford Health
Priority to JP2016506643A priority Critical patent/JP2016515433A/ja
Priority to BR112015019493A priority patent/BR112015019493A2/pt
Priority to CN201480009200.1A priority patent/CN105228685A/zh
Priority to EP14734261.2A priority patent/EP2981323A1/fr
Priority to CA2901178A priority patent/CA2901178C/fr
Priority to AU2014248069A priority patent/AU2014248069A1/en
Priority to HK16107530.4A priority patent/HK1219447A1/zh
Priority to KR1020157019992A priority patent/KR20160005674A/ko
Publication of WO2014165751A1 publication Critical patent/WO2014165751A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • 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
    • A61M25/104—Balloon catheters used for angioplasty
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0059—Catheters; Hollow probes characterised by structural features having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves

Definitions

  • Local drug delivery is the process by which therapeutic agents are delivered to specific areas within the vasculature of a human or animal patient. This localized treatment permits an increased concentration of the drag or therapeutic agent at the intended target area but avoids toxicity that may result through general systemic delivery within the circulatory system.
  • Known localized drug delivery methods include dmg-eluting stents or balloons, porous drug infusion balloons and direct catheter delivery.
  • the present invention is directed to methods and apparatus for the delivery of a drug solution or a therapeutic agent to selected site wifcm the vascular system using a dr g delivery balloon apparatus.
  • the drug delivery balloon apparatus of the present invention may beneficially permit an increased balloon length that may be up to four times longer than that of other known balloons providing the advantage of treating larger injury sites in a single procedure.
  • the drug delivery balloon apparatus of the present invention may also provide a plurality of grooves for receiving the drug solution during deliver ⁇ - to the target passage. These grooves may beneficially guide the flow of the drag solution through the target passage, while at the same time slowing the drug flow to increase the amount of time that the drag is in contact with the wall of th target passage.
  • the drug delivery balloon apparatus and its associated channels also can help to minimize the volume of drug solution required by occupying a portion of the luminal volume.
  • the drag deliver ⁇ - balloon apparatus may further include an occlusion balloon that may inflate upstream from the drag delivery balloo to permit adequate pressure to be maintained in the system during infusion to effectively advance the drug or therapeutic agent into and along the plurality of grooves on the outer surface of the drag delivery balloon.
  • the occlusion balloon also helps to prevent peripheral washout by blocking blood flow from the treatment area.
  • the present invention provides a drug delivery balloon apparatus comprising: (a) at least two lumens, comprising a first lumen and a second lumen, (b) a balloon inflation port in communication with the first lumen, (c) a drug delivery port in communication with the second lumen, (d) a guidewire port in communication with either the second lumen or a third lumen, (e) an occlusion balloon, (i) a drug delivery balloon, wherein an outer surface of the drug delivery balloon defines a plurality of grooves extending from a first end of the drag delivery balloon to a second end of the drug delivery bailoon, wherein the occlusion balloon is disposed between the drug delivery balloon and the balloon inflation port, wherein the occlusion balloon and the drag delivery balloon are in communication with the first lumen, (g) one or more drag delivery channels extending the length of the second lumen, (h) one or more drag delivery ducts extending from the one or more drug delivery channels to an exterior surface of the second lumen,
  • the invention provides that the plurality of grooves may be axially aligned with a central axis of the hug delivery balloon.
  • the plurality of grooves may be spiraied, helical, substantially straight, sinusoidal, or cross-hatched, for example.
  • the drag delivery port may be branched such that two, three, four or more different drug solutions or other solutions may be introduced into the drag delivery port.
  • the invention may provide that the one or more drag delivery channels comprises four channels and each drag delivery channel may be in coiimimiication with three drug delivery ducts such that ther e are a total of twelve drug delivery ducts.
  • the present invention also provides a method for administering at least one drug to a subject in need thereof using a drag delivery balloon apparatus, the method comprising: (a) introducing the cling delivery balloon apparatus according to the first aspect of the invention to a target passage, (b) inflating the occlusion balloon and the drug delivery balloon, (c) injecting a drug solution into the ding delivery port, and (d) advancing the drag solution through the second lumen to the one or more drag delivery ducts mto the target passage in the subject and then into and along a plurality of grooves defined in an outer surface of the drug delivery balloon.
  • Figure 1A is a side view of drug delivery balloon apparatus, in accordance with one embodiment of the invention.
  • Figure IB is a front cross-sectional view of a two lumen configuration of the drug delivery balloon apparatus, in accordance with one embodiment of the invention.
  • Figure 1C is a front cross-sectional view of a three lumen configuration of the drug delivery balloon apparatus, in accordance with one embodiment of the invention.
  • Figure ID is a side view of the occlusion balloon and the drug delivery balloon of the drug delivery balloon apparatus, in accordance with one embodiment of the invention.
  • Figure IE is a detail cross-sectional side view of the drug delivery balloon, in accordance with one embodiment of the invention.
  • Figure 2 is a flow chart depicting functions that can be carried out in accordance with example embodiments of the disclosed methods.
  • target passage refers to the blood vessel or artery in which the drug delivery balloon is deployed to effectively administer a drug solution.
  • the target passage may further include artificial lumens used, for example, as teaching aids.
  • drug solution refers to any flowable materia! that may be administered into a target passage.
  • the drug solution comprises a therapeutic to be administered to a subject
  • any suitable drug that can be administered in solution can be used.
  • the therapeutic may comprise sirolimus, heparin, and cell-based therapies; and antineoplastic, anti-inflammatory, antiplatelet, anticoagulant, antifibrin, antidirombm, antimitotic, antibiotic, antiallergic and antioxidant substances.
  • antineoplastics and/or antimitotics include paciitaxei, (e.g., TAXOL.RTM.
  • docetaxel e.g., Taxotere.RTM., from Aventis S.A., Frankfurt,. Germany.
  • methotrexate e.g., azathioprine, vincristine, vinblastine, fliiorouracil, doxorubicin hydrochloride (e.g., Adriamycin.RTM. from Pharmaci & Upjohn, Peapack N.J.). and mitomycin (e.g... Mutamyc.ii.RTM. from Bristol-Myers Squibb Co., Stamford, Conn.).
  • antiplatelets examples include aspirin, sodium heparin, low molecular weight heparins, heparinoids, hirudin, argatroban, forskohn, vapiprost, prostacyclin and prostacycli analogues, dextran, D- phe-piO-arg-c oromemylketone (synthetic antithrombin), dipyridamole, glycoprotein Hb/IUa platelet membrane receptor antagonist antibody, recombinant hirudin, and thrombin inhibitors such as Angiomas a (Biogen, Inc., Cambridge. Mass.).
  • cytostatic or antiproliferative agents examples include angiopeptin, angiotensin converting enzyme inhibitors such as captopril (e.g., Capoten.RTM, and Capozide.RTM. from Bristol-Myers Squibb Co.. Stamford, Conn.), cilazapril or lisinopril (e.g., PriniviLRTM. and Prinzide.RTM.
  • angiopeptin e.g., Capoten.RTM, and Capozide.RTM. from Bristol-Myers Squibb Co.. Stamford, Conn.
  • captopril e.g., Capoten.RTM, and Capozide.RTM. from Bristol-Myers Squibb Co.. Stamford, Conn.
  • cilazapril or lisinopril e.g., PriniviLRTM. and Prinzide.RTM.
  • PDGF Platelet-Derived Growth Factor
  • nitropi sside phosphodiesterase inhibitors
  • prostaglandin inhibitors nitropi sside
  • suramin nitropi sside
  • serotonin blockers nitropi sside
  • steroids thioprotea.se inhibitors
  • triazolopyrimidine a PDGF antagonist
  • nitric oxide nitric oxide.
  • an antiallergic agent is pemiirolast potassium.
  • Other therapeutic substances or agents which may be appropriate agents include eisplafin, insulin sensitizers, receptor tyrosine kinase inhibitors, carboplatm, alpha-mterferou, genetically engineered epithelial cells, steroidal anti-inflammatory agents, non-steroidal anti- inflanirnatoiy agents, antivirals, anticancer drugs, anticoagulant agents, free radical scavengers, estradiol, antibiotics, nitric oxide donors, super oxide dis iutases, super oxide disniutases mimics, 4-aimno-2,2,6,6-tetraiiiethylpipei'idme-l -oxyl (4-annno-TEMPQ), tacrolimus, dexamediasone.
  • eisplafin insulin sensitizers, receptor tyrosine kinase inhibitors, carboplatm, alpha-mterferou, genetically engineered epithelial
  • ABT-578 clobetasol
  • cytostatic agents prodrugs thereof, co- drugs thereof, and a combination thereof.
  • Other therapeutic substances or agents may include raparnycin and structural derivatives or functional analogs thereof, such as 40-O-(2- hydroxy)etliyl-i'apamycin (known by the trade name of EVEROLIMUS), 40-O-(3- hydroxy)propyl-rapamycin, 40-O-[2-(2-hydroxy) €thoxy3ethyl-rapamyciii 5 methyl rapamycin, and 40-O-tetrazole-rapaniycin.
  • non-therapeutic fluids such as water, may be used, if the drug delivery balloon apparatus is being used in a teaching model or training demonstration, for example.
  • Figure iA illustrates an example drag delivery balloon apparatus 100 in accordance with one embodiment of the invention.
  • the drag delivery balloon apparatus 100 may include three ports: (1) a balloon inflation port 102 that inflates both an occlusion bailoou 104 and a dmg delivery balloon 106, (2) a drug delivery port 108 through which a drug solution is administered, and (3) a guidewire port 110 for receiving a guidewire and the inflated occlusion balloon 104 and drag delivery balloon 106.
  • the drug delivery port 108 may be bifurcated, such that two, three, four or more different drag solutions or oilier solutions may be introduced into the drag deliveiy port 108 as deemed appropriate for treatment.
  • the balloon apparatus 100 may include a first lumen 114 in communication with the balloon inflation port 102 and may be configured to receive a saline contrast mixture, or any other suitable fluid medium, to inflate the occlusion balloo 104 and the drag deliveiy balloon 106. Further, the balloon apparatus 100 may include a second lumen 116 in communication with the drug delivery port 108 and the guidewire port 110. In one embodiment, the second !umen 116 may be sized and shaped to receive a drug solution.
  • the second lumen 116 may also be sized and shaped to receive a guidewire having a diameter in the range from about 0.25 mm to about 1 mm, and preferably in a range from about 0.254 mm to about 0.9652 nun
  • the first lumen 114 and the second lumen 116 may be enclosed in a sheath 118.
  • the second lumen 116 may include one or more drug delivery channels 120 extending the length of the second lumen 116. These drag delivery channels 120 may be used to transport the drug solution from the drug delivery port 10S to a target passage.
  • the second lumen 116 may also include a guidewire channel 122 extending the length of the second lumen 116.
  • the second lumen 116 may include a single channel for both the guidewire and drug solution.
  • the guidewire may be removed after use so that the drug solution can pass through the second lumen 116.
  • the balloon apparatus 100 may be configured to infuse the drug solution while the guidewire is in the second lumen 116.
  • the second lumen 116 would have a larger diameter than the guidewire from a location between the guidewire port 110 and the drug delivery port 10S until just distal to the drug delivery ducts 146.
  • the second lumen 116 would shrink down to about the diameter of the guidewire just distal to the drag delivery ducts 146 to the distal end of the balloon.
  • the second lumen 116 would shrink down to about the diameter of the guidewire proximal to the drug delivery port 108, so as to prevent the drug solution from exiting the guidewire port 110.
  • a flange or one-way valve may be used to prevent the drag solution from exiting the guidewire port 110.
  • Other configurations are possible as well.
  • the three ports may be coupled to three concentrically aligned lumens 124.
  • Figure 1C illustrates a front cross-sectional view of the three lumens 124.
  • the three concentrically aligned lumens 124 comprise an inner dutyn 126, a middle lumen 128, and an outer lumen 130, where the first lumen is arranged as the inner lumen, the second lume is arranged as the middle lumen and the third lumen is arranged as the outer lumen.
  • the inner lumen 126 may be in coimnunkatio with the guidewire port 110 and may be sized and shaped to receive a guidewire having a diameter in the range from about 0.25 mm to about 1 mm, and preferably in a range from about 0.254 mm to about 0.9652 mm.
  • the middle lumen 128 may be in communication with the drug delivery port 108.
  • the middle lumen 128 may include a plurality of flexible spacers 1 2 mat extend between the inner lumen 126 and the outer lumen 130 to mamtam the structural integrity of the middle lumen 128. These spacers 132, in combination with the middle lumen 128 and the inner lumen 126.
  • the outer lumen 130 may further define a one or more drug delivery channels 134 extending the length of the middle lumen 12S. As discussed above, these drug delivery channels 134 may be used to transport the drag solution from the drug delivery port 108 to a target passage.
  • the outer lumen 130 may be in communication with the balloon inflation port 102.
  • the outer lumen 130 may also include a plurality of flexible spacers 136 to help maintain the structural integrity of the outer lumen 130. These spacers 136, in combination with the outer lumen 130 and middle lumen 128. may also define a plurality of fluid delivery channels 138 extending the length of the outer lumen 130. These fluid delivery channels 138 may be in fluid communication with the occlusion balloon 104 and the drug delivery balloon 106.
  • Figure ID illustrates the occlusion baiioon 104 and the drug delivery balloon 106 of the drug deliver ⁇ - balloon apparatus 100.
  • the occlusion balloon 104 may be composed of atraumatic, compliant materials such as polyurethane, latex, or silicone, among other possibilities, that results in a low burst pressure of about 5 atm, for example. However, the occlusion balloon 104 may be configured to withstand greater pressures, tor example up to about 20 ami. The occlusion balloon 104 may be configured to conform to the shape and size of fee target passage via low pressure inflation, about i to 2 aim.
  • the occlusion balloon 104 may provide occlusion in the target passage to allow for drug delivery into the target passage downstream from the occlusion balloon 104 to minimize dilution of the drug solution from blood flow.
  • the inflated diameter of the occlusion balloon 104 may range from about 2.5 mm to about 12 mm and is preferably in a range from about 2.5 na to about 6 mm.
  • the length of the occlusion balloon 104 may range from about 20 mm to about 40 mni.
  • the inflated diameter of the occlusion balloon 104 ranges from about fee same as fee inflated diameter of fee drug delivery balloon 106 to about 2 mm larger than the inflated diameter of the drag delivery balloon 106.
  • the occlusion balloon 104 may be inflated prior to the introduction of the drug solution into fee drug delivery port 108,
  • the drug delivery balloon 106 may be made of compliant materials such as polyurethane, latex, or silicone that results in a low burst pressure of about 5 aim, for example.
  • the length of fee drug delivery balloon 106 may range from about 20 mm to about 200 mm.
  • the length of the drag delivery balloon 106 ranges from about SO mm to about 200 mm. from about 100 mm to about 200min, from about 120 mm to about 200 mm, from about 140 mm to about 200 mm, from about 160 mm to about 200 mm, from about ISO mm to about 200 nun, from about 60 mm to about 120 mm, from about 60 mm to about 1 0 mi and from about 10 mm to about 80 mm.
  • the drug delivery balloon 106 may have an inflated diameter ranging from about 2.5 mm to about 12 mm and is preferably in a range from about 2.5 mm to about 6 mm. In various embodiments, the inflated diameter of the drag delivery balloon 106 may range from about 2.5 mm to about 3 MI from about 4 mm to about 5 mm. and from about 5 mm to about 6 mm.
  • the outer surface of the drug deliver ⁇ - balloon 106 may define a plurality of grooves i 40 for receiving the drug solution. These grooves i 40 may extend from the first end 142 to the second end 144 of the drag delivery balloon 106.
  • the plurality of grooves 140 may serve to (1) guide the flow of the drug solution and (2) slow the flow of the drag solution to increase the time of contact of the drug with the wall of the target passage.
  • the plurality of grooves 140 are preferably axial!y aligned with a central axis of the drug delivery balloon
  • 106 may be spiraled, helical, sinusoidal or substantially straight, among other possibilities, in various embodiments. Spiraled, helical or sinusoidal grooves are preferred over straight grooves,, because the more tortuous grooves provide more surface area to contact the vessel wall and further extend the amount of time that the drug solution contacts the vessel wall Further, any pattern of grooves is contemplated including a cross-hatched or waffle pattern, tor example.
  • the occlusion balloon 104 may be disposed between the cling delivery balloon 106 and the balloon inflation port 102 such that both the occlusion balloon 104 and the drug dehvery balloon 106 may be in commtniication with the second lumen 116 or the outer lumen 130 and receive fluid from the balloon inflation port 102.
  • the occlusion balloon 104 and the drug delivery balloon 106 may be separated from each other by a distance ranging from about 1 mm to about 10 mm, and preferably from about 3 mm to about 5 mm. This distance allows adequate pressure to be maintained in the system such mat the drug solution may be effectively advanced into and along the plurality of grooves 140 on the oute surface of the drug delivery balloon 106.
  • One or more drug delivery ducts 146 may extend from the one or more drag delivery channels 120 defined in the second lumen 116 to an exterior surface of the second lumen 116. These drug delivery ducts 146 may be defined in a portion 148 of the second lumen 116 that is disposed between the occlusion balloon 104 and the chug deliver balloon 106. In other words, these drug delivery ducts 130 may be downstream from the occlusion balloon 104 in operation.
  • the one or more drug delivery channels 120 may comprise four to eight channels.
  • the one or more drug delivery channels 120 is each in fluid communication with one to six drag delivery ducts 146.
  • the one or more drug delivery channels 120 may comprise four channels and each drug delivery channel may be in fluid communication with three drug delivery ducts such that there are a total of twelve drug delivery ducts.
  • the number of drag delivery ducts may depend upon the length of portion 148 of the second lume 116 extending between the occlusion balloon 104 and the drag delivery balloon 106 and/or the diameter of the drug delivery ducts 146, among other possibilities.
  • Figure IE illustrates a cross-sectional side view of the drug delivery balloon 106.
  • the drag delivery balloon 106 includes a plurality of grooves 140.
  • the drug solution advances downstream into and along the plurality of grooves 140 defined in the outer surface of the drug delivery balloon 106. Once the drag solution exits the plurality of grooves 140 at the second end 144 of the drag delivery balloon 106, the drug solution may be cleared via normal arterial blood flow and ultimate physiological function.
  • Figure 2 is a simplified flow chart illustrating a method according to an exemplary embodiment. Although the blocks are illustrated in a sequential order, these blocks may also be performed in parallel, and/or in a different order man those described herein. Also, the various blocks may be combined into fewer blocks, divided into additional blocks, and/or removed based upon the desired implementation.
  • the method involves introducing the drag delivery balloon apparatus according to any of the foregoing embodiments to a target passage.
  • the drug delivery balloon apparatus may be introduced and delivered in a standard coaxial manner, via over- tlie-wire or rapid exchange techniques, as examples.
  • the method involves inflating the occlusion balloon and the drag delivery balloon.
  • the occlusion balloon and the ding delivery balloon may be inflated by injecting a saline contrast mixture, for example, into the balloon inflation port.
  • the saline contrast mixture may the be advanced through a first hmien to the occlusion balloon and the drug delivery balloon until both balloons are inflated.
  • the occlusion balloon may uiflate at a slightly fester rate, since the occhision balloon and the drug delivery balloon are connected in series such that the occlusion balloon receives the saline contrast inflation mixture first
  • the occlusion balloon and drug delivery balloon may be inflated using any other suitable fluid medium.
  • the method continues at block 206 with injecting a ding solution into the drug delivery port.
  • the drug delivery port is biftircated, such that two, three, four or more different drug solutions or other solutions may be introduced into the drug delivery port as deemed appropriate.
  • the method involves advancing the drug solution through a second lumen to the one or more drag delivery ducts into a target passag in the subject.
  • the space between the occlusion balloon and the drug delivery balloon acts as a reservoir storing the drug solution as it is delivered via the drug delivery ducts.
  • the drag solution advances downstream into and along the plurality of grooves defined in the outer surface of the drug delivery balloon.
  • the pressure at which the drug solution is administered should not exceed about 2 aim.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne un appareil à ballonnet (100) pour l'administration de médicaments, qui comprend au moins deux lumières, notamment une première lumière (114) et une seconde lumière (116), un orifice (102) destiné au gonflage du ballonnet, un orifice (110) pour fil-guide, un orifice (108) pour pour l'administration de médicaments, un ballonnet d'occlusion (104), un ballonnet d'administration (106) de médicaments présentant une surface externe dotée d'une pluralité de rainures (140), le ballonnet d'occlusion étant situé entre le ballonnet d'administration de médicaments et l'orifice destiné au gonflage du ballonnet, et le ballonnet d'occlusion et le ballonnet d'administration de médicaments communiquant avec la première lumière, un ou plusieurs canaux (120) d'administration de médicaments situés sur la longueur de la seconde lumière, et un ou plusieurs conduits (146) d'administration de médicaments s'étendant entre le ou les canaux d'administration de médicaments et la surface externe de la seconde lumière.
PCT/US2014/032964 2013-04-05 2014-04-04 Appareil à ballonnet pour l'administration de médicaments Ceased WO2014165751A1 (fr)

Priority Applications (8)

Application Number Priority Date Filing Date Title
JP2016506643A JP2016515433A (ja) 2013-04-05 2014-04-04 薬物送達バルーン装置
BR112015019493A BR112015019493A2 (pt) 2013-04-05 2014-04-04 aparelho de balão de distribuição de drogas e método para a administração de pelo menos uma droga a um indivíduo necessitado da mesma usando-se um aparelho de balão de distribuição de drogas
CN201480009200.1A CN105228685A (zh) 2013-04-05 2014-04-04 药物递送气囊装置
EP14734261.2A EP2981323A1 (fr) 2013-04-05 2014-04-04 Appareil à ballonnet pour l'administration de médicaments
CA2901178A CA2901178C (fr) 2013-04-05 2014-04-04 Appareil a ballonnet pour l'administration de medicaments
AU2014248069A AU2014248069A1 (en) 2013-04-05 2014-04-04 Drug delivery balloon apparatus
HK16107530.4A HK1219447A1 (zh) 2013-04-05 2014-04-04 药物递送气囊装置
KR1020157019992A KR20160005674A (ko) 2013-04-05 2014-04-04 약물 전달 풍선 장치

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361809176P 2013-04-05 2013-04-05
US61/809,176 2013-04-05

Publications (1)

Publication Number Publication Date
WO2014165751A1 true WO2014165751A1 (fr) 2014-10-09

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PCT/US2014/032964 Ceased WO2014165751A1 (fr) 2013-04-05 2014-04-04 Appareil à ballonnet pour l'administration de médicaments

Country Status (9)

Country Link
EP (1) EP2981323A1 (fr)
JP (1) JP2016515433A (fr)
KR (1) KR20160005674A (fr)
CN (1) CN105228685A (fr)
AU (1) AU2014248069A1 (fr)
BR (1) BR112015019493A2 (fr)
CA (1) CA2901178C (fr)
HK (1) HK1219447A1 (fr)
WO (1) WO2014165751A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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WO2018165311A1 (fr) * 2017-03-07 2018-09-13 Sanford Health Ballonnet de perfusion et ses procédés d'utilisation
US11690981B2 (en) 2017-03-07 2023-07-04 Sanford Health Infusion balloon and methods for use thereof
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HK1219447A1 (zh) 2017-04-07
EP2981323A1 (fr) 2016-02-10
CA2901178A1 (fr) 2014-10-09
AU2014248069A1 (en) 2015-07-30
CA2901178C (fr) 2018-05-01
JP2016515433A (ja) 2016-05-30
CN105228685A (zh) 2016-01-06
KR20160005674A (ko) 2016-01-15
BR112015019493A2 (pt) 2017-07-18

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