WO2014165751A1

WO2014165751A1 - Drug delivery balloon apparatus

Info

Publication number: WO2014165751A1
Application number: PCT/US2014/032964
Authority: WO
Inventors: Patrick K. KELLY
Original assignee: Sanford Health
Priority date: 2013-04-05
Filing date: 2014-04-04
Publication date: 2014-10-09
Also published as: BR112015019493A2; CA2901178C; AU2014248069A1; KR20160005674A; EP2981323A1; CN105228685A; CA2901178A1; HK1219447A1; JP2016515433A

Abstract

A drug delivery balloon apparatus 100, where the drug delivery balloon apparatus comprises: at least two lumens, a first lumen 114 and a second lumen 116, a balloon inflation port 102, a guidewire port 110, a drug delivery port 108, an occlusion balloon 104, a drug delivery balloon 106 having an outer surface with a plurality of grooves 140, where the occlusion balloon is disposed between the drug delivery balloon and the balloon inflation port, and the occlusion and drug delivery balloons are in communication with the first lumen, one or more drug delivery channels 120 extending the length of the second lumen, and one or more drug delivery ducts 146 extending from the one or more drug delivery channels to an exterior surface of the second lumen.

Description

DRUG DELIVERY BALLOON APPARATUS

Related Applications

This application is a non-provisional of and claims priority to U.S. Provisional Application No. 61/809 J 76 entitled "Drug Delivery Balloon Apparatus & Methods for Use," filed on April 5, 2013, which is hereby incorporated by reference in its entirety.

Background of the Invention

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.

Summary of the Invention

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. In addition, 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.

Thus, in a first aspect 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, and wherein the one or more drug delivery ducts are defined only in a portion of the second lumen that is disposed between the occlusion balloon and the hug delivery balloon.

In one embodiment, the invention provides that the plurality of grooves may be axially aligned with a central axis of the hug delivery balloon. In various other embodiments, the plurality of grooves may be spiraied, helical, substantially straight, sinusoidal, or cross-hatched, for example. Further, in one 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.

In another embodiment, 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.

In a second aspect, 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.

Brief Description of the Drawings

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.

Detailed Description of the Invention

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 understood that certain aspects of the disciosed systems and methods can be arranged and combined in a wide variety of different configurations, ail 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 less of each element shown in a given Figure. Further, some of the illustrated elements may be combined or omitted. Yet further, an exemplary embodiment may include elements that are not illustrated in the Figures.

As used herein, with respect to measurements, "about" means +/- 5 %. Further, as used herein, "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.

In addition, as used herein, "drug solution" refers to any flowable materia! that may be administered into a target passage. When the drug solution comprises a therapeutic to be administered to a subject, any suitable drug that can be administered in solution can be used. In various non-limiting embodiments, the therapeutic may comprise sirolimus, heparin, and cell-based therapies; and antineoplastic, anti-inflammatory, antiplatelet, anticoagulant, antifibrin, antidirombm, antimitotic, antibiotic, antiallergic and antioxidant substances. Examples of such antineoplastics and/or antimitotics include paciitaxei, (e.g., TAXOL.RTM. by Bristol-Myers Squibb Co., Stamford, Conn.), docetaxel (e.g., Taxotere.RTM., from Aventis S.A., Frankfurt,. Germany)., methotrexate, 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.). Examples of such antiplatelets, anticoagulants, antifibrin, and antidironibins 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.). Examples of such cytostatic or antiproliferative agents 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. from Merck & Co., Inc., Whitehouse Station, N.J.), calcium channel blockers (such as nifedipine), colchicine, proteins, peptides, fibroblast growth factor (FGF) antagonists, fish oil (omega 3-fatty acid), histamine antagonists, !ovastatin (an inhibitor of HMG-CoA reductase, a cholesterol lowering drug, brand name Mevacor.RTM. from Merck & Co.. Inc., hitehouse Station, N.J.), monoclonal antibodies (such as those specific for Platelet-Derived Growth Factor (PDGF) receptors), nitropi sside, phosphodiesterase inhibitors, prostaglandin inhibitors, suramin, serotonin blockers, steroids, thioprotea.se inhibitors, triazolopyrimidine (a PDGF antagonist), and nitric oxide. An example of 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. 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-rapamyciii₅ methyl rapamycin, and 40-O-tetrazole-rapaniycin. In addition, 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.

In a first aspect. 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. In one example embodiment as shown i Figure 1A, 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.

In one example, the three ports lead to two parallel lumens 112. Figure IB illustrates a front cross-sectional view of the two lumens. 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. In one embodiment, 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 In one embodiment, 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. In another example, the second lumen 116 may include a single channel for both the guidewire and drug solution.

In such a configuration, the guidewire may be removed after use so that the drug solution can pass through the second lumen 116. hi operation, the balloon apparatus 100 may be configured to infuse the drug solution while the guidewire is in the second lumen 116. In such a configuration, 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. Further, 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. In another example, 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.

In another embodiment, the three ports may be coupled to three concentrically aligned lumens 124. For example. Figure 1C illustrates a front cross-sectional view of the three lumens 124. As shown in Figure IC, the three concentrically aligned lumens 124 comprise an inner iunien 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. 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. Once inflated 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. In one embodiment, 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. In operation, 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. hi various embodiments, 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. In one embodiment, 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 and 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. In one embodiment, the one or more drug delivery channels 120 may comprise four to eight channels. In another embodiment, the one or more drug delivery channels 120 is each in fluid communication with one to six drag delivery ducts 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 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. As shown in Figure IE, the drag delivery balloon 106 includes a plurality of grooves 140. In operation, 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.

At. block 202, 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.

At block 204, the method involves inflating the occlusion balloon and the drag delivery balloon. In one embodiment 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 In another embodiment, the occlusion balloon and drug delivery balloon may be inflated using any other suitable fluid medium.

After bom the occlusion balloon and the drag delivery balloon have been inflated, the method continues at block 206 with injecting a ding solution into the drug delivery port. In one embodiment 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.

At block 208, 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. At this stage, 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. Due to the pressure at which the dra solution is being introduced to the drag delivery port, 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. Once the drug solution exits the plurality of grooves at the second end of the drag delivery balloon, the drug solution may be cleared via normal arterial blood flow and ultimate physiological function.

While 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 the invention can be combined unless the context clearly dictates otherwise. The various aspects and embodiments disclosed herein are tor purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims.

Claims

1. A drug delivery balloon apparatus comprising:

at least two lumens, comprising a first lumen and a second lumen:

a balloon inflation port in communication with the first lumen;

a drag delivery port in communication with the second lumen:

a guidewire port in communication with either the second lumen or a third lumen; an occlusion balloon;

a dru delivery balloon, wherem an outer surface of the drag delivery balloon defines a plurality of grooves extending from a firs end of the drag delivery balloon to a second end of the drug delivery balloon, wherein the occlusion balloon is disposed between the drug delivery baiioon and the balloon inflation port wherein the occlusion balloon and the drug delivery balloon are in communication with the first lumen;

one or more drag delivery channels extending the length of the second lumen; and one or more drag delivery ducts extending from the one or more drug delivery channels to an exterior surface of the second lumen, and wherein the one or more drug delivery ducts are defined only in a portion of the second lumen that is disposed between the occlusion balloon and the drag delivery balloon.

2. The drag delivery balloon apparatus of claim 1, wherein the guidewire port is in commiBiication with the second lumen.

3. The drag delivery balloon apparatus of claim 1, further comprising a third lumen, wherein the guidewire port is communication with the third lumen, wherein the first lumen, the second lumen and the third lumen are concentrically aligned such that the third lumen is arranged as an inner iitmen, the second lumen is arranged as a middle luin n and the first lumen is arranged as an outer lumen.

4. The drug delivery balloon apparatus of any of claims i-3, wherein the plurality of grooves are axially aligned with a central axis of the drug delivery balloon.

5. The drag deiiveiy balloon apparatus of any of claims 1-4, wherein the plurality of grooves are spiraled, helical, substantially straight, or sinusoidal.

6. The drug delivery balloon apparatus of any of claims 1-5, wherein the plurality of grooves are cross-hatched,

7. The drug delivery balloon apparatus of any of claims 1-6, wherein the occlusion balloon and the drag delivery balloon are separated from each other by a distance ranging from about 3 mm to about 5 mm.

8. The drug delivery balloon apparatus of any of claims 1-7, wherein the drug deiiveiy port is bifurcated,

9. The drug delivery balloon apparatus of any of claims 1-8, wherein the occlusion balloon and the drag delivery balloon each have an inflated diameter in the range from about 2.5 mm to about 12 mm.

10. The drug deiiveiy balloon apparatus of any of claims 1-9, wherein the inflated diameter of the occhision balloon ranges from about the same as the inflated diameter of the drug delivery balloon to about 2 ram larger than the inflated diameter of the drug delivery balloon.

11. The drug delivery balloon apparatus of any of claims 1-10, wherein the occlusion balloon ranges in length from about 20 mm to about 40 mm.

12. The drug delivery balloon apparatus of any of claims 1-11, wherein the drug delivery balloon ranges in length from about 50 mm to about 200 mm,

13. The drug delivery balloon apparatus of any one of claims 1-12, wherein the drag delivery balloon is about 200 mm in length.

14. The drag delivery balloon apparatus of any of claims 1-13, wherein the guidewire port is sized to receive a guidewire having a diameter in the range of about 0.254 mm to about 0.9652 mm.

15. The drag delivery balloon apparatus of any of claims 1-14, wherein the one or more drag delivery channels comprises four to eight channels.

16. The drug delivery balloon apparatus of any of claims 1 -15. wherein the one or more drug delivery channels is each in fluid communication with one to six drug delivery ducts.

17. The drag delivery balloon apparatus of any of claims 1-16, wherein the one or more drug delivery channels comprises four channels and each drug delivery channel is in communication with three drug delivery duels such that there are a total of twelve drag deiiveiy ducts.

IS. A method for administering at least one drug to a subject in need thereof using a drug deiiveiy balloon apparatus, the method comprising:

introducing the drug delivery balloon apparatus of any one of claims 1-1? into a target passage;

inflating the occlusion balloon and the drag deiiveiy balloon:

injecting a drug solution into the drug delivery port: and

advancing the drag solution through the second lumen to the one or more drug deiiveiy ducts into the target passage in the subject and then into and along a plurality of gr ooves defined in an outer surface of the drug deiiveiy balloon.

19. The method of claim 18, wherein injecting the drag solution is performed at a fluid pressure at or below 2 aim.

20. The method of claims 18 or 19, wherein the inflated diameter of the occlusion balloon ranges fiom about the same as the inflated diameter of the drug deiiveiy balloon to about 2 mm larger than the inflated diameter of the dr ug deiiveiy balloon.

21. The method any one of claims 18-20, wherein inflating the occlusion balloon and the drug deiiveiy balloon comprises;

injecting a saline contrast mixture into the balloon inflation port; and

advancing the saline contrast mixture through one of the at least two lumens to the occlusion balloon and the drag deiiveiy balloon.