CN105228685A - Drug delivery airbag apparatus - Google Patents

Abstract

Drug delivery balloon device 100, wherein the drug delivery balloon device comprises: at least two cavities, first cavity 114 and second cavity 116, balloon inflation hole 102, guide wire hole 110, drug delivery hole 108, occlusion balloon 104, drug delivery The airbag 106, the outer surface of the drug delivery balloon 106 has a plurality of grooves 140, wherein the occlusive balloon is arranged between the drug delivery balloon and the balloon inflation hole, and the occlusive balloon and the drug delivery balloon communicate with the first cavity, one or more drug delivery balloons Delivery channel 120 extends the length of the second lumen, and one or more drug delivery conduits 146 extend from the one or more drug delivery channels to the outer surface of the second lumen.

Description

Drug Delivery Balloon Device

related application

This nonprovisional patent application claims US Provisional Patent Application No. 61/809,176, filed April 5, 2013, and entitled "Drug Delivery Balloon Device and Method of Use," which is hereby incorporated by reference in its entirety.

Background technique

Local administration is the process by which a therapeutic agent is delivered to a specific area of the vascular system of a human or animal patient. Such localized treatment results in an increased concentration of the drug or therapeutic agent in the intended target area while avoiding the toxicity in the circulatory system that would normally result from systemic administration. Known methods of topical drug delivery include DMG-eluting stents or balloons, porous drug infusion balloons, and direct catheter delivery

Contents of the invention

The present invention relates to methods and devices for delivering a medical fluid or therapeutic agent to a selected site within the vascular system using a drug delivery balloon device. The drug delivery balloon device of the present invention may advantageously allow for increased balloon length which may be up to four times that of other known balloons, providing the advantage of treating larger lesion sites in a single session. The drug delivery balloon device of the present invention may also provide a plurality of channels for receiving the drug fluid during delivery to the target pathway. These grooves can advantageously direct the flow of drug fluid through the target channel while slowing down the drug flow to increase the amount of time the drug is in contact with the walls of the target channel. The drug delivery balloon device and its associated channels can also help minimize the volume of drug fluid required to occupy a portion of the lumen volume. Additionally, the drug delivery balloon device may also include occlusive balloons that may be inflated upwardly from the drug delivery balloon such that sufficient pressure is maintained in the system during infusion to effectively propel the drug or therapeutic agent into and along the plurality of drug delivery balloon outer surfaces. on the slot. The occlusive balloon also helps prevent peripheral washout by blocking blood flow to the treated area.

Accordingly, in a first aspect, the present invention provides a drug delivery balloon device comprising: (a) at least two lumens comprising a first lumen and a second lumen, (b) a balloon inflatable in communication with the first lumen hole, (c) a drug delivery hole communicating with the second lumen, (d) a guide wire hole communicating with any one of the second lumen and the third lumen, (e) an occlusion balloon, (f) a drug delivery balloon, wherein the drug The outer surface of the delivery balloon defines a plurality of grooves extending from the first end of the drug delivery balloon to the second end of the drug delivery balloon, wherein the occlusion balloon is disposed between the drug delivery balloon and the balloon inflation hole, wherein the occlusion balloon and the drug delivery The balloon communicates with the first lumen, (G) one or more drug delivery channels extending the length of the second lumen, (h) one or more drug delivery channels extending from the one or more drug delivery channels to the outer surface of the second lumen catheter, and wherein one or more drug delivery catheters are defined in a portion of the second lumen that is disposed between the occlusion balloon and the drug delivery balloon.

In one embodiment, the present invention provides a plurality of slots that can be axially aligned with the central axis of the drug delivery balloon. In various other embodiments, the plurality of grooves may be convoluted, helical, substantially straight, sinusoidal, or cross-hatched, for example. Further, in one example the drug delivery hole can be dendritic such that two, three, four or more different drug or other solutions can be introduced into the drug delivery hole.

In another embodiment, the present invention may provide one or more drug delivery channels, including four channels and each drug delivery channel may communicate with three drug delivery conduits such that there are a total of twelve drug delivery conduits.

In a second aspect, the present invention also provides a method for administering at least one drug to a subject in need using a drug delivery balloon device, the method comprising: (a) introducing a drug according to the first aspect of the invention delivering the balloon to the target channel, (b) inflating the occlusive balloon and the drug delivery balloon, (c) injecting the drug fluid into the drug delivery hole, and (d) advancing the drug fluid through the second lumen into one or more drug delivery catheters The subject's target pathway then enters and follows a plurality of grooves defined in the outer surface of the drug delivery balloon.

Description of drawings

Figure 1A is a side view of a drug delivery balloon device according to one embodiment of the present invention.

Figure IB is a front cross-sectional view of a two-chamber configuration of a drug delivery balloon device, according to one embodiment of the present invention.

Figure 1C is a front cross-sectional view of a three-chamber configuration of a drug delivery balloon device, according to one embodiment of the present invention.

Figure ID is a side view of an occlusion balloon and a drug delivery balloon of a drug delivery balloon device according to one embodiment of the present invention.

Figure IE is a detailed side cross-sectional view of a drug delivery balloon according to one embodiment of the present invention.

FIG. 2 is a flowchart depicting a method that may be performed in accordance with an example embodiment of the disclosed method.

detailed description

Exemplary methods and systems are described herein. It should be understood that the word "exemplary" is used herein to mean "serving as an example, instance or illustration". Any embodiment or feature described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments or features. The exemplary embodiments described herein are not meant to be limiting. It will be readily appreciated that certain aspects of the disclosed systems and methods can be arranged and combined in a wide variety of different configurations, all of which are contemplated herein.

Furthermore, the particular arrangements shown in the figures should not be viewed as limiting. It should be understood that other embodiments may include more or fewer elements than each element in a given figure. Also, some of the illustrated elements may be combined or omitted. Still further, exemplary embodiments may include elements not shown in the figures.

As used herein, "about" means ± 5% relative to measurement. Furthermore, as used herein, "target channel" refers to a blood vessel or artery in which a drug delivery balloon is deployed to effectively administer a drug fluid. The target channel may also include an artificial lumen, eg, for use as a teaching aid.

Furthermore, as used herein, "medicinal fluid" refers to any flowable material that can be applied to a target channel. When the medical fluid includes a therapeutic agent administered to a subject, any suitable drug that can be administered in solution may be used. In various non-limiting examples, therapeutic agents can include? Sirolimus, heparin, and stem cell therapy; and antineoplastic agents, anti-inflammatory agents, antiplatelet agents, anticoagulants, antifibrin antibodies, antithrombin, antimitotic agents, antibiotics, antiallergic agents, and antioxidant substances . Examples of such antineoplastic and/or antimitotic agents include paclitaxel, (e.g., TAXOL.RTM from Bristol-Myers Squibb, Stamford, Conn.), docetaxel (e.g., Taxotere.RTM, from Aventis SA, Frankfurt, Germany) , methotrexate, azathioprine, vincristine, vinblastine, fluorouracil, doxorubicin hydrochloride (eg, Adriamycin. .RTM was from Bristol-Myers Squibb, Stamford, CT). Examples of such antiplatelet agents, anticoagulants, antifibrin antibodies, and antithrombin include aspirin, sodium heparin, low molecular weight heparin, heparinoids, hirudin, argatroban, forskolin, vaperoprost , prostacyclin and prostacyclin analogs, dextran, D-phenylalanine-PIO arginine-C chloromethyl ketone (synthetic antithrombin), dipyridamole, glycoprotein IIb/IIIa platelet membrane receptor Antagonist antibodies, recombinant hirudin, and thrombin inhibitors such as captopril (Biogenetics, Cambridge, MA). Examples of such cytostatic or antiproliferative drugs include angiopep, angiotensin converting enzyme inhibitors such as captopril (e.g., Capoten.RTM and Capozide.RTM from Bristol-Myers Squibb Co., Stamford, Conn.), Syrah Prinzide or lisinopril (eg, Prinivil.RTM and Prinzide.RTM, from Merck & Co., Ltd., White House Station, NJ), calcium channel blockers (eg, nifedipine), colchicine, proteins, peptides , fibroblast growth factor (FGF) antagonist, fish oil (omega-3-fatty acid), histamine antagonist, lovastatin (HMG-CoA reductase inhibitor, cholesterol-lowering drug, brand name Mevacor.RTM, from Merck & Co., Hitehouse Station, NJ), monoclonal antibodies (such as those specific for the platelet-derived growth factor (PDGF) receptor), nitrohydrocyanates, phosphodiesterase inhibitors , prostaglandin inhibitors, suramin, serotonin blockers, steroids, protease inhibitors, triazolopyrimidines (PDGF antagonists), and nitric oxide. An example of an antiallergic agent is pemilulast potassium. Other therapeutic substances or agents may include platinum-based drugs, insulin sensitizers, receptor tyrosine kinase inhibitors, carboplatin, alpha-interferon, genetically modified epithelial cells, non-steroidal anti-inflammatory Inflammatory agent, antiviral agent, anticancer agent, anticoagulant, free radical scavenger, estradiol, antibiotic, nitric oxide donor, superoxide dismutase, superoxide dismutase mimetic, 4-amino acid -2,2,6,6-tetramethylpiperidine--1-oxyl (4-amino acid-TEMPQ), tacrolimus, dexamethasone. ABT-578, clobetasol, cytostatic agents and prodrugs, co-drugs and combinations thereof. Other therapeutic substances or agents may include rapamycin and structural derivatives or functional analogs thereof, such as 40-O-(2-hydroxy)ethyl-rapamycin (known by the trade name Everolimus known), 40-O-(3-hydroxy)propyl-rapamycin, 40-O-[2-(2-hydroxy)ethyl]ethyl-rapamycin, methylrapamycin rapamycin and 40-O-tetrazolium rapamycin. Additionally, non-therapeutic fluids, such as water, may also be used if the drug delivery balloon device is being used in a teaching mode or training demonstration, for example.

In a first aspect, FIG. 1A illustrates an exemplary drug delivery balloon device 100 according to one embodiment of the present invention. Drug delivery balloon device 100 may include three holes: (1) balloon inflation hole 102 for inflating occlusion balloon 104 and drug delivery balloon 106, (2) drug delivery hole 108 through which a drug solution is administered, and (3) Guidewire hole 110 for receiving a guidewire and occlusion balloon 104 and drug delivery balloon 106 . In one example embodiment, as shown in FIG. 1A , the drug delivery port 108 can be bifurcated so that two, three, four or more different medical fluids or other solutions can be introduced into the drug delivery port. 108, depending on the treatment.

In one example, three holes lead to two parallel cavities 112 . Figure IB shows a front cross-sectional view of the two chambers. The balloon device 100 may include a first lumen 114 in communication with the balloon inflation hole 102 and may be configured to receive a saline contrast mixture, or other suitable fluid medium, to inflate the occlusion balloon 104 and the drug delivery balloon 106 . Furthermore, the balloon device 100 may include a second lumen 116 in communication with the drug delivery aperture 108 and the guidewire aperture 110 . In one embodiment, the second cavity may be sized and shaped to receive medical fluid. In one embodiment, the second lumen 116 may also be sized and shaped to receive a guide wire having a diameter ranging from about 0.25 mm to about 1 mm, and preferably ranging from about 0.254 mm to about 0.9652 mm. In one embodiment, first lumen 114 and second lumen 116 may be encased in sheath 118 . Second lumen 116 may include one or more drug delivery channels 120 extending the length of second lumen 116 . These drug delivery channels 120 can be used to transport drug fluid from the drug delivery holes 108 to the target channel. The second lumen 116 may also include a guidewire channel 122 extending the length of the second lumen. In another example, the second lumen 116 may include a single channel for both the guidewire and medical fluid.

In such a configuration, the guidewire can be removed after use so that medical fluid can pass through the second lumen 116 . In operation, the balloon device 100 may be configured to infuse a medical fluid while the guidewire is in the second lumen 116 . In such a configuration, second lumen 116 has a larger diameter than the guidewire from a location between guidewire hole 110 and drug delivery hole 108 until just distal to drug delivery catheter 146 . The second lumen 116 will narrow to about the diameter of the guidewire just distal to the distal end of the drug delivery catheter 146 to the balloon. In addition, the second lumen 116 will narrow to about the diameter of the guidewire proximally of the drug delivery hole 108 , preventing drug fluid from exiting the guidewire hole 10 . In another example, a flange or one-way can be used to prevent medical fluid from exiting the guidewire hole 110 . Other configurations are also possible.

In another embodiment, three holes may be coupled to three concentrically aligned cavities 124 . For example. FIG. 1C shows a front cross-sectional view of the triple chamber 124 . As shown in FIG. 1C, three concentrically aligned lumens 124 include an inner lumen 126, a middle lumen 128, and an outer lumen 130, wherein the first lumen is arranged as the inner lumen, the second lumen is arranged as the middle lumen and the third lumen is arranged as the inner lumen. For the outer cavity. Lumen 126 may communicate with guidewire bore 110 and may be sized and shaped to receive a guidewire having a diameter in the range of about 0.25 mm to about 1 mm, preferably ranging from about 0.254 mm to about 0.9652 mm. Intermediate lumen 128 may communicate with drug delivery aperture 108 . Intermediate lumen 128 may include a plurality of flexible spacers 132 extending between inner lumen 126 and outer lumen 130 to maintain the structural integrity of intermediate lumen 128 . These spacers 132 , in combination with the intermediate lumen 128 and the inner lumen 126 , can further define one or more drug delivery channels 134 extending the length of the intermediate lumen 128 . As mentioned above, these drug delivery channels 134 can be used to transport drug fluid from the drug delivery aperture 108 to the target channel. The outer cavity 130 may communicate with the airbag inflation hole 102 . The outer cavity 130 may also include a plurality of flexible spacers 136 to help maintain the structural integrity of the outer cavity 130 . These dividers 136 in conjunction with the outer lumen 130 and the intermediate 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 are in fluid communication with the occlusion balloon 104 and the drug delivery balloon 106 .

ID shows the occlusion balloon 104 and the drug delivery balloon 106 of the drug delivery balloon device 100 . The occlusive balloon 104 may be composed of an atraumatic, compatible material such as polyurethane, latex, or silicone, among other possibilities, a material resulting in a low burst pressure of about 5 atmospheres, for example. However, the occlusion balloon 104 may be configured to withstand greater pressures, for example up to about 20 atmospheres. Inflated at low pressure, about 1 to 2 atmospheres, the occlusion balloon 104 can be configured to conform to the size and dimensions of the targeted passageway. Once inflated, the occlusion balloon can provide an occlusion in the target channel allowing drug delivery into the target channel downstream from the occlusion balloon 104 to minimize dilution of the drug solution by blood flow. The diameter of the inflated occlusive balloon may range from about 2.5 mm to 12 mm and preferably ranges from about 2.5 mm to about 6 mm. The length of the occlusive balloon may vary from about 20mm to about 40mm. In one embodiment, the inflated diameter of the occlusion balloon 104 ranges from about the same as the inflated diameter of the drug delivery balloon 106 to 2 mm longer than the inflated diameter of the drug delivery balloon 106 . In operation, the occlusive balloon 104 may be inflated prior to introducing a medical fluid into the drug delivery aperture 108 .

The drug delivery balloon 106 may be made of a compatible material such as polyurethane, latex or silicone resulting in a low burst pressure of about 5 atmospheres, for example. The length of the drug delivery balloon 106 can vary from about 20 mm to about 200 mm. In various embodiments, the length of the drug delivery balloon 106 is from about 80mm to about 200mm, from about 100mm to about 200mm, from about 12mm to about 200mm, from about 140mm to about 200mm, from about 160mm to about 200mm, from about 180mm to About 200mm, ranging from about 60mm to about 120mm, about 60mm to about 100mm and from about 10mm to about 80mm. In one embodiment, drug delivery balloon 106 may have an inflated diameter ranging from about 2.5 mm to about 12 mm and preferably ranging from about 2.5 mm to about 6 mm. In various embodiments, the inflated diameter of drug delivery balloon 106 can range from about 2.5 mm to 3 mm, from about 4 mm to about 5 mm, and from 5 mm to about 6 mm.

The outer surface of the drug delivery balloon 106 may define a plurality of grooves 140 for receiving a drug fluid. The slots 140 may extend from a first end 142 of the drug delivery balloon 106 to a second end 144 of the drug delivery balloon 106 . The plurality of grooves 140 may serve to (1) direct the flow of the drug fluid and (2) slow down the flow of the drug fluid to increase the time the drug is in contact with the walls of the target channel. The plurality of slots 140 are preferably axially aligned with the central axis of the drug delivery balloon 106 . and may be spiral, helical, sinusoidal, or substantially straight, among other possibilities, in various embodiments. Convoluted, helical, or sinusoidal grooves are preferred over straight grooves because more tortuous grooves provide greater surface area contact with the vessel wall and further extend the amount of time the drug fluid contacts the vessel wall. Also, any pattern of grooves is contemplated, including cross-hatch or waffle patterns, for example.

Occlusion balloon 104 may be disposed between drug delivery balloon 106 and balloon inflation hole 102 such that both occlusion balloon 104 and drug delivery balloon 106 may communicate with second or outer lumen 130 and receive fluid from balloon inflation hole 102 . The occlusion balloon 104 and the drug delivery balloon 106 may be separated from each other by a distance of from about 1 mm to about 10 mm, and preferably from about 3 mm to about 5 mm. This distance allows sufficient pressure to be maintained in the system so that drug fluid can be efficiently entered into and along the plurality of grooves 140 on the outer surface of the drug delivery balloon 106 .

One or more drug delivery conduits 146 may extend from one or more drug delivery channels 120 defined within second lumen 116 to an outer surface of second lumen 116 . The drug delivery conduits 146 may be defined within a portion 148 of the second lumen 116 that is disposed between the occlusion balloon 104 and the drug delivery balloon 106 . In other words, the drug delivery catheters 130 can be downstream from the occlusion balloon 104, in operation. In one embodiment, the one or more drug delivery channels 120 may include four to eight channels. In another embodiment, each of the one or more drug delivery channels 120 is in fluid communication with one to six drug delivery conduits 146 . In a further embodiment, 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 conduits such that there are a total of twelve drug delivery conduits. The number of drug delivery catheters may depend on the length of portion 148 of second lumen 116 that extends between occlusion balloon 104 and diameter of drug delivery balloon 106 and/or drug delivery catheter 146 , among other possibilities.

FIG. 1E shows a cross-sectional side view of drug delivery balloon 106 . As shown in FIG. 1E , the drug delivery balloon 106 includes a plurality of slots 140 . In operation, the drug fluid is pushed down into and along a plurality of grooves 140 defined in the outer surface of the drug delivery balloon 106 . Once the medical fluid exits the plurality of slots 140 at the second end 144 of the drug delivery balloon 106, the medical fluid may be purged by normal arterial blood flow and ultimate physiological function.

Fig. 2 is a simplified flowchart illustrating a method according to an exemplary embodiment. Although the blocks are shown in a sequential order, the blocks may be performed in parallel and/or in an order different from that described herein. Furthermore, various blocks may be combined into fewer blocks, divided into additional blocks, and/or removed depending on the desired implementation.

At block 202, the method involves introducing a drug delivery balloon device into a target channel according to any one of the preceding embodiments. Drug delivery balloon devices can be introduced in a standard coaxial manner, by in-line or rapid exchange techniques, as examples.

At block 204, the method involves inflating the occlusion balloon and the drug delivery balloon. In one embodiment, the occlusion balloon and the drug delivery balloon can be inflated by injecting a saline contrast mixture into the balloon inflation holes, for example. The saline contrast mixture can then be advanced through the first lumen to the occlusion balloon and the drug delivery balloon until both balloons are inflated. The occlusion balloon can be inflated at a somewhat faster rate since the occlusion balloon and the drug delivery balloon are connected in series so that the occlusion balloon first receives the saline contrast mixture. In another embodiment, the occlusion balloon and drug delivery balloon may be inflated using any other suitable fluid medium.

After both the occlusion balloon and the drug delivery balloon have been inflated, the method continues to block 206 to inject the drug fluid into the drug delivery hole. In one embodiment the drug delivery hole is bifurcated so that two, three, four or more different kinds of drugs or other solutions can be introduced into the drug delivery hole, as the case may be.

At block 208, the method involves advancing the medical fluid through the second lumen to a target channel of the one or more drug delivery catheters into the subject. At this stage, the space between the occlusion balloon and the drug delivery balloon serves as a reservoir for storing the drug fluid as it is delivered through the drug delivery catheter. Due to the pressure of the drug fluid being introduced into the drug delivery aperture, the drug fluid is propelled down into and along a plurality of grooves defined on the outer surface of the drug delivery balloon. The pressure at which the liquid solution is administered should not exceed about 2 atmospheres. Once the drug fluid exits the plurality of slots at the second end of the drug delivery balloon, the drug fluid can be removed by normal arterial blood flow and ultimate physiological function.

Although various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. All embodiments within and between different aspects of this aspect may be combined unless the context clearly dictates otherwise. The various aspects and embodiments disclosed herein are intended to be illustrative rather than limiting, with the true scope and spirit being indicated by the following claims.

Claims (21)

1. A drug delivery balloon device comprising: at least two chambers, including a first chamber and a second chamber; an airbag inflation hole communicating with the first cavity; a drug delivery aperture in communication with the second lumen; a guide wire hole communicating with the second lumen or the third lumen; occlusive air bag; 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 drug delivery balloon to a second end of the drug delivery balloon, wherein the occlusive balloon is disposed on the between the drug delivery balloon and the balloon inflation hole, wherein the occlusion balloon and the drug delivery balloon communicate with the first cavity; one or more drug delivery channels extending the length of the second lumen; and one or more drug delivery conduits extending from the one or more drug delivery channels to the outer surface of the second lumen, and wherein the one or more drug delivery conduits are confined only to the exterior of the second lumen In one portion, the portion is disposed between the occlusion balloon and the drug delivery balloon. 2. The drug delivery balloon device of claim 1, wherein the guidewire hole communicates with the second lumen. 3. The drug delivery balloon device of claim 1, further comprising a third lumen, wherein the guide wire hole communicates with the third lumen, wherein the first lumen, the second lumen and the first lumen The three lumens are concentrically aligned such that the third lumen is arranged as an inner lumen, the second lumen is arranged as an intermediate lumen and the first lumen is arranged as an outer lumen. 4. The drug delivery balloon device of any one of claims 1-3, wherein the plurality of grooves are axially aligned with a central axis of the drug delivery balloon. 5. The drug delivery balloon device of any one of claims 1-4, wherein the plurality of grooves are helical, helical, substantially straight or sinusoidal. 6. The drug delivery balloon device of any one of claims 1-5, wherein the plurality of grooves are cross-hatched. 7. The drug delivery balloon device of any one of claims 1-6, wherein the occlusive balloon and the drug delivery balloon are separated from each other by a distance ranging from about 3 mm to about 5 mm. 8. The drug delivery balloon device of any one of claims 1-7, wherein the drug delivery aperture is bifurcated. 9. The drug delivery balloon device of any one of claims 1-8, wherein the occlusive balloon and the drug delivery balloon each have a diameter ranging from about 2.5 mm to about 12 mm. 10. The drug delivery balloon device of any one of claims 1-9, wherein the inflated diameter of the occlusive balloon is from about the same as the inflated diameter of the drug delivery balloon to about 2 mm longer than the drug delivery balloon change. 11. The drug delivery balloon device of any one of claims 1-10, wherein the length of the occlusive balloon ranges from about 20mm to about 40mm. 12. The drug delivery balloon device of any one of claims 1-11, wherein the drug delivery balloon has a length ranging from about 50mm to about 200mm. 13. The drug delivery balloon device of any one of claims 1-12, wherein the drug delivery balloon has a length of about 200 mm. 14. The drug delivery balloon device of any one of claims 1-13, wherein the guidewire hole is sized to receive a guidewire having a diameter in the range of about 0.254 mm to 0.9652 mm. 15. The drug delivery balloon device of any one of claims 1-14, wherein the one or more drug delivery channels comprise four to eight channels. 16. The drug delivery balloon device of any one of claims 1-15, wherein the one or more drug delivery channels are each in fluid communication with one to six drug delivery conduits. 17. The drug delivery balloon device of any one of claims 1-16, wherein the one or more drug delivery channels comprise four channels and each drug delivery channel communicates with three drug delivery conduits so that there are a total of Twelve drug delivery catheters. 18. A method for administering at least one drug to a subject in need thereof using a drug delivery balloon device, the method comprising: introducing a drug delivery balloon device according to any one of claims 1-17 into the target channel; inflating the occlusion balloon and the drug delivery balloon; injecting a drug solution into the drug delivery hole; and A medical fluid is propelled through the second lumen to the one or more drug delivery catheters into a subject target channel and then into and along a plurality of grooves defined in the outer surface of the drug delivery balloon. 19. The method of claim 18, wherein infusing the medical fluid is performed at a fluid pressure at or below 2 atmospheres. 20. The method of claim 18 or 19, wherein the inflated diameter of the occlusive balloon ranges from about the same as the inflated diameter of the drug delivery balloon to about 2mm longer than the drug delivery balloon. 21. The method of any one of claims 18-20, wherein inflating the occlusion balloon and the drug delivery balloon comprises: injecting a saline contrast mixture into the balloon inflation hole; and Propelling the saline contrast mixture through at least one of two lumens to the occlusion balloon and the drug delivery balloon.