CA2216646A1

CA2216646A1 - Multiple hole drug delivery balloon

Info

Publication number: CA2216646A1
Application number: CA002216646A
Authority: CA
Inventors: Susan M. Ropiak
Original assignee: Boston Scientific Corporation; Susan M. Ropiak
Current assignee: Boston Scientific Corp
Priority date: 1995-03-31
Filing date: 1996-03-29
Publication date: 1996-10-03
Also published as: EP0819011A4; JP3787358B2; DE69626635T2; EP0819011B1; US5860954A; EP0819011A1; DE69626635D1; US5843033A; JPH11503039A; WO1996030064A1

Abstract

An inflatable medical device (10) for delivery of medication to an organ in the body having a multi-lumen catheter (12) and a hollow, inflatable channel-like medication deliverable balloon (14) at the distal end of the catheter. A
plurality of conduits (32) extend along the balloon between the walls (42, 44) of the balloon for delivery of medications. Each conduit includes an array (40) of closely spaced apertures for allowing medications in the conduits to transfer out of the conduits into a surrounding vessel after the balloon is inflated.

Description

W 096/30064 PCT~US9~10~361 Description Multiple Hole Druq Delivery Balloon Technical Field This invention generally relates to balloon catheters ~or forcibly expanding a coronary artery and for dispensing medications. More particularly this invention is directed to a balloon catheter capable o~ delivering medications and to a method of manufacturing such a balloon catheter.
10 Backqround Art Balloon catheters for expanding atherosclerotic lesions or stenosises are well known in the heart. Such devices include inflatable balloons disposed at the end of multi-lumen catheter shafts. A pressurizing fluid forced into the balloon through an in~lation lumen expands the balloon into the surface of an artery to enlarge its cross section.
United States Letters Patent No. 4,994,033 to Shockey et al. discloses a variation on a balloon catheter that is designed to apply a liquid medicament or other substance to a stenotic lesion as the blood vessel is undergoing dilatation to facilitate the restoration and long-term maintenance of patency to the blood vessel. This particular catheter includes three concentrically arranged flexible plastic tubes and a pair o~ concentrically arranged expansion members located at the distal end of the tubes. The space between the outer wall of the inner tube and the inner wall of the intermediate tube is in ~luid communication with the interior o~ the first expander member. The second space between the outer wall of the intermediate tube and the inner wall o~ the outer tube is in fluid communication with the interior of the second expander member. A plurality of minute holes are formed through the second expander member to permit the liquid medicament to be ejected from the second expander member while an inflation fluid is introduced into the lumen of the intermediate tube.

CA 022l6646 l997-09-26 W 096/30064 PCTrUS~/0~61 Essentially, the Shockey et al. patent discloses two concentric balloons with an annular chamber formed between the balloons for receiving a medication that then disperses through the outer balloon through a series of 5 holes. Other devices for performing these functions also exist. For example, Unites States Letter Patent No.
~ 5,207,644 to Strecker discloses a similar device in the form of an implantable infusion chamber; and United States Letters Patent No. 5,320,604 to Walker et al. discloses a 10 pair of expander balloons spaced apart on opposite sides of a waist portion at the distal end of a catheter in which the waist portion includes an infusion section with a perforation in communication with a drug delivery lumen.
United States Letters Patent No. 4,693,243 to Buras discloses a flexible, non-collapsible conduit system for directly ;~t~m;ni stering topical anesthesia in which the conduit system is separately positioned about a cuffed endotracheal tube for a direct topical application of additional substances to tissues of the larynx. United States Letters Patent No. 5,295,962 to Crocker et al.
discloses a drug delivery and dilatation catheter that includes a inflation balloon disposed about a catheter and a perforated drug delivery balloon disposed concentrically about the inflation balloon. The drug delivery balloon contains a plurality of delivery ports over some or all of the surface of the delivery balloon or alternatively comprises a permeable material. United States Letters Patent No. 5,049,132 to Shaffer et al. also discloses a balloon catheter with concentric balloons. In this patent the outer balloon has apertures or slits that permit liquid flow outwardly through the balloon.
Increasing the pressure applied at the proximal end of many of the foregoing balloon catheters for administering a medicant increases the flow rate through the apertures . With sufficient pressure, "jetting~
occurs whereby a relatively high-velocity stream emerges from the balloon with enough momentum to damage surrounding tissue. As one solution to this problem ~096/30064 PCTrUS9f'n~61 United States Letters Patent No. 5,213,576 to Abiuso et al. discloses two concentric balloons in which a medicament is directed into a central balloon and escapes through apertures in the inner balloon that are o~set from apertures in an outer balloon. Each of the apertures or ports is sized to permit medication delivered through the lumen to pass outwardly through the perforations o~
both balloons, but the offset nature of the apertures prevents jetting.
United States Letters Patent No. 5,318,531 to Leone discloses an alternative infusion balloon catheter in which a balloon carries a plurality of holes sized to permit medication to be delivered through a lumen to pass outwardly through the holes. The balloon also carries on 15 an outer sur~ace a substantially hydrophilic, tubular, microporous membrane that covers the holes to break up streams of ~lowing medication.
More recently, an alternative balloon catheter, called a channel balloon, has been developed ~or the treatment o~ vascular disease including the delivery o~
medication to a site. One embodiment o~ such a balloon is shown in United States Letters Patent No. 5,254,089 to Wang. This channel balloon comprises a hollow, in~latable, extruded medication delivery balloon at the 25 distal end o~ the catheter. Like other balloons, the interior o~ the channel balloon is in ~luid ~low relationship with one o~ several catheter lumens to enable the balloon to be in~lated. In this particular structure, however, the balloon has inner and outer walls and 30 angularly spaced radial webs that de~ine an array o~
longitudinally extending conduits between the walls o~ the balloon. Another lumen in the catheter shaft delivers medication to these conduits, and the walls o~ the balloon have a single aperture ~or allowing the release o~ the 35 medication ~rom each conduit.
In the particular embodiment shown in the Wang patent, each conduit has a single port ~ormed by in~lating both the balloon and the conduits with air and then W 096130064 PCTrUS96/04361 pricking each conduit wall lightly with a pin until it deflates. It is also suggested that the conduits could be pierced with laser irradiation. Apertures in the range from 0.0025 mm to 2.5 mm are suggested as potential 5 aperture sizes depending upon the viscosity of the medication being dispensed. Elongated slits and other alternative aperture shapes are suggested.
As the medicament being administered moves directly through the exterior wall from an individual conduit in 10 this channel balloon, jetting from the single apertures can still occur. Moreover, forming apertures in the outer wall is more complicated in a channel balloon that it is in a concentric balloon structure. For example, with individual concentric balloons it is possible to laser 15 drill holes through one balloon as an outer balloon while it is separated from the final catheter assembly and then to overlay the outer balloon on the inner balloon. With conventional laser drilling, the laser is energized for an interval that assures complete penetration of the material 20 being drilled. In a channel balloon, however, that approach to laser drilling would require sophisticated controls designed to produce just sufficient energy during a single application of laser energy to drill the exterior wall without significantly penetrating or weakening of the inner wall. Otherwise the structural integrity of the entire channel balloon can be compromised. Instead, these single ports are formed by incremental pulsing of a laser beam so it removes only a portion of the exterior wall.
As each laser pulse interacts with the exterior wall, reflections at the walls tend to produce uneven energy distributions across the hole being drilled. This process can form tabs of material that are weakly connected to the rh~nn~l balloon. There is always a potential for such material to release and ~orm debris that can block the channel or, in the worst case, exit with the medication into the patient. These and other criteria would require the implementation o~ complicated and unduly expensive CA 022l6646 l997-09-26 W~ /3C C1 PCT/U~G~a~?Cl manu~acturing controls to adapt prior art procedures for avoiding jetting to an extruded channel balloon.
Disclosure o~ Invention Therefore, it is on object o~ this invention to 5 provide an improved inflatable medical device for the intravascular delivery of medications.
Another object o~ this invention is to provide an improved inflatable medical device that mln;mi zes jetting ef~ects during the administration of a medication.
Still another object o~ this invention is to provide an improved inflatable medical device for the intravascular delivery of medication at high flow rates without jetting ef~ects.
Yet another object of this invention is to provide an 15 improved in~latable medical device for the intravascular delivery of medications with a channeled expansible balloon.
Yet still another object of this invention is to provide an improved inflatable, channeled balloon catheter 20 for the administration of medication that is readily manu~actured.
Still yet another object of this invention is to provide an improved, reliable and inflatable, channeled balloon catheter medical device ~or the intravascular 25 delivery of medications.
In accordance with one aspect of this invention, a medical device for the intravascular delivery of medications includes an inflatable balloon having at least one conduit that extends between interior and exterior 30 walls for substantially the entire length of the balloon.
Lumens are provided for inflating the balloon and for 7 delivering medications to the conduit. An array o~
closely spaced ports through the exterior wall are grouped in an area that is significantly less than the area of the 35 exterior wall coextensive with the conduit thereby to enable medication to exit the conduit.
In accordance with another aspect of this invention, a medical device for the delivery of medications includes W 096/30064 PCTrUS96~04361 a multi-lumen catheter having a distal end adapted to be disposed within a bodily organ. A hollow, inflatable, balloon defined by interior and exterior walls and distal and pro~; m~ 1 ends is disposed on the distal end of the catheter. The interior of the balloon is in fluid flow relationship with one lumen to enable the introduction of an inflation fluid to the interior of the balloon. A
plurality of conduits formed intermediate the interior and exterior walls receive medications. The exterior wall of 10 each conduit has a given exterior wall area. Each conduit is adapted to receive medications through another lumen and includes an array of closely spaced ports through the exterior wall. Each array covers an area that is significantly less than the exterior wall area over the conduit.
In accordance with another aspect of this invention an inflatable medical device for the delivery of medications to an organ in the body includes a hollow, inflatable, medication-deliverable balloon defined by interior and exterior walls. The exterior wall contains an array of closely spaced ports constructed by positioning an optical mask proximate the exterior wall.
The optical mask includes a plurality of apertures therethrough that correspond to the desired array. Laser 25 pulses are directed toward the optical mask with the energy in a single pulse limited to a level that removes only an incremental portion of the exterior wall material.
The pulse energy is spread to illuminate all the apertures in the mask simultaneously. The process is monitored 30 until the presence of laser energy on the inner wall is detected whereupon the sequence of laser pulses terminates.
Brief Description of the Drawings The appended claims particularly point out and 35 distinctly claim the subject matter of this invention.
The various objects, advantages and novel features of this invention will be more fully apparent from a reading of the following detailed description in conjunction with the W 0 96/30064 PCTrUS9"01~61 accompanying drawings in which like reference numerals re~er to like parts, and in which:
FIG. 1 is a side elevational view of a medical balloon according to the present invention shown in an inflated configuration with a portion of balloon being cut away to show its interior;
FIG. 2 is cross section taken along lines 2-2 in FIG.
1 showing the attachment between the catheter shaft and the balloon;
FIG. 3 is an enlarged plan view o~ a portion o~ the balloon in FIG. 1 that includes one conduit and portions o~ adjacent conduits;
FIG. 4 depicts the portion o~ the balloon shown in FIG.3 in perspective;
FIG. 5 depicts, schematically and in block form, apparatus use~ul in the manu~acture o~ a balloon constructed in accordance with this invention; and FIGS. 6A through 6D depict the formation o~ a single aperture through an exterior wall o~ the balloon during 20 manufacture on the apparatus shown in FIG. 5.
Best Mode for Carrying Out the Invention A balloon-type catheter 10 o~ the present invention is similar to other catheters used for treating coronary artery disease. As is conventional, the catheter 10 attaches to an array of hubs (not shown) being typically made of rigid materials. These hubs enable the introduction of inflation ~luids, medication and a guide wire as will be described hereina~ter. The hubs attach to the proximal end o~ a multilllm~n~l tube or catheter sha~t 12 as is conventional.
The catheter shaft 12 carries a medical balloon 14 at its distal end. The balloon 14 comprises materials described herein and is heat sealed or adhesively attached (as is conventional) at its respective proximal end 16 and 35 distal end 18 to the catheter sha~t 12. A collar 20 ~its around the proximal end 16 of the balloon 14; an optional collar may be attached to the distal end 18. An inflation port (not shown) provides communication between the W 096/30064 PCTrUS96104361 interior of the balloon 14 and an inflation lumen 24, as also known in the art. Lumen 24 communicates with any desired source of inflation fluid at the hubs mentioned above as is conventional for balloon catheters.
The medication lumen 26 extends completely through the catheter shaft 12 and communicates with a medication injection port 28 at the proximal end 16 of the balloon 14. The medication injection port 28 communicates with a manifold 30 that is formed between the collar 20 and the catheter shaft 12 and that is in fluid flow communication with medication dispensing conduits 32.
A third lumen 34 extends completely through the catheter shaft 12. This lumen 34 allows a conventional guidewire 36 to be inserted through the balloon 14 to 15 assist in catheter insertion in a conventional manner.
FIGS. 3 and 4 depict a portion of a balloon 14 that forms one conduit 32 and portions of adjacent conduits 32A
and 32B and that, as shown in FIGS. 1, 3 and 4, includes an array 40 of apertures or ports for dispensing 20 medication. Still referring to FIGS. 3 and 4, the balloon 14includes an inner cylindrical expansible wall 42 and an outer expansible wall 44 spaced from the inner wall 42 by radially extending webs 46.
The array 40 of apertures includes, in this specific 25 embodiment an array of eighteen ports 48(1) through 48(18) organized in three rows centered on parallel axes 50(1), 50(2), 50(3) that parallel the webs 46. The apertures 48 additionally are arranged in offsetting columns. For example, ports 48(1) and 48(13) are at the intersections 30 of a center line 52(1) with center lines 50(1) and 50(3), respectively. Ports along the axis 50(2), such as port 48(7), are offset and lie on a center line 52(2) parallel to center lines 52(1) and 52(3) and midway therebetween.
If dl represents the distance between adjacent ones of the 35 axes 50; d2, the distance between the center lines of adjacent ports along an axis such as the distance between center line 52(1) and 53(3); and d3, half the distance of ~VO~-'3~~C1 PCTrUS96/0436 _g_ d2, spacing for maintaining the integrity of the material intermediate adjacent ports can be realized so long as

2 2d d2 2 2d d3 2 d where "d" is the nominal diameter of an individual one of the ports 48. I~ the ports 48 have a diameter of 30~m, according to equations (1) through (3) the array 40 occupies an area of about 150~m by 330~m. In one 10 particular embodiment the distance d2 is increased over the minimum and the array 40 has an area of 160~m by 450~m whereby the m; n~ mllm spacing between adjacent ports in any direction is equal to or greater than the port diameter, d.
The production of a balloon 14 as shown in FIGS. 3 and 4 with an array 40 can be accomplished with the specifically disclose,d pattern shown in FIGS. 3 and 4 or with any alternate configuration. The number of ports 48 can be varied. In accordance with certain objectives o~
this invention, however, in whatever form, this structure allows medication transmitted throughout the conduit 32 to ooze from the ports 48 collectively. Given the close proximity of the apertures 48 and their small sizes, the individual ports seem to act more like capillaries than 25 nozzles, so the medication streams or jets observable in the prior art do not appear. This jetting is overcome without adding materials to the balloon or constructing a balloon with inner and outer ports that necessitates the use of an inflation fluid, the removal of an inflation fluid and the subsequent introduction o~ an additional fluid for the purposes of inflating the balloon and therea~ter ~m; n; stering the medicine, with its obvious complexity and disadvantages.
FIG. 5 schematically depicts manufacturing apparatus 60 that is useful in ~orming the array 40. In one particular embodiment, an excimer laser 62 and conventional laser optics 64 form a laser beam having W 096130064 PCTrUS9CI0~61 boundaries represented by dashed lines 66 and that covers an area corresponding to at least the area of the array to be formed. As previously indicated, an array generally will cover an area less than lmm2 (i.e. less than 1000 ~m 5 on each side). With such areas optics 64 can produce a substantially even energy distribution across the area of the array. The methods for producing a laser pulse having these characteristics and a sequence of such pulses is well known in the art.
An optical mask 68 includes a plurality of apertures, such as apertures 70(1) through 70(18), that correspond to the array 40. After the mask 68 is interposed between the laser optics and the exterior wall 44, laser energy from the optics 64 strikes the mask 68, but passes through the 15 mask 68 only in the areas corresponding to the various apertures 70 in the mask. Consequently the laser optics ~ 64 and mask 68 will illuminate the exterior wall 44 with laser energy in the desired pattern. Dashed lines 72 depict the transfer of energy througR the aperture 70(13) 20 to the exterior wall 44.
The apparatus 60 additionally includes a pulse control circuit 74 that establishes laser parameters of pulse amplitude, width and repetition to enable the laser 62 to illuminate the mask 68 with a sequence of controlled finite energy pulses. More speci~ically, it is desired to control pulse amplitude and width so each pulse removes only an incremental portion of the material in the exterior wall 44. If the balloon 14 is extruded from polyethylene terapthalate or similar material, the pulse control circuit 74 may limit each laser pulses to an energy of 1 millijoule, such that it requires 20 to 25 pulses penetrate the exterior wall 44.
FIGS. 6A through 6D depict the progressive removal of one aperture through the exterior wall 44 under the application of a series of laser pulses. FIG. 5A
represents the balloon 14 after the laser beam 72 has been pulsed one or two times and depicts a slight depression 76A made by the removal of a first incremental portion of W 096130064 PCT/U~10~61 the material of the exterior wall 44. Successive pulses deepen the hole as shown in FIG. 6B by the depression 76B
in the exterior wall 44. A~ter a number o~ pulses, the laser will remove all the material in the exterior wall 44 5 as shown in FIG. 6C. A next laser pulse passes through the aperture 76C shown in FIG. 6D and strikes the interior wall 42. In essence, the materials in the walls 42 and 44 generally are opaque or semi-opaque so an operator can visually determine when an aperture such as aperture 76 is ~ully formed by the appearance of a surface irregularity on the interior wall 42. At that point the operator stops the laser pulse sequence.
Normally, the laser pulse control 74 may be as simple as a manually activated single-pulse circuit so each pulse is controlled individually. Alternatively, the m~nl]~l control might initiate a short pulse train o~ 2 or more pulses in a burst. Typically this control would be designed so that only one or two pulses would be generated after the hole 76C is ~ully ~ormed. These pulses may ~orm a surface irregularity 78 on the inner wall 42. However, the incremental material that is actually removed does not a~ect the overall strength or integrity of the inner wall 42.
Mechanically forming apertures such as apertures 48 in FIG. 2 by pricking or otherwise can produce ~lashing around the hole. Even a tightly focused laser beam for drilling a single hole can produce flashing around the peripheral edges because there can be a significant variation in energy distribution across the diameter of the hole. Such ~lashing is dif~icult to remove, particularly in a channel balloon, and it is possible for such flashing to detach during use. The laser optics 64 in FIG. 5 spreads the resulting laser beam over the array and assures a relatively constant energy distribution 35 across portions o~ the beam passing through the optical mask 68 that is in a single laser beam represented by the dashed line 72. As the energy in each beam from the mask 68 will be substantially constant, each hole 48 tends to CA 022l6646 l997-09-26 W O9~3___1 PCT~US96/01361 form at equal rates through the exterior wall 46 so that within one or two pulses all the holes will be bored at the same time. This ml n;ml zes any damage by laser energy impacting the interior wall 42.
Moreover, as compared with the prior art, the combination of the use of the mask to form an array of small holes, rather than a single hole also minimizes the size of any tabs or flash that remain after ~orming the holes. Whereas such tabs or flashing in prior art sufficiently large to produce problems if they were to migrate into a patient, with the process of this invention any flashing or tabs that might be produced are of negligible size and quantity.
As will now be appreciated, conventional laser drilling is not adapted for producing an array in a channel balloon. Laser pulse width and amplitude are selected to form a port with one pulse. Any variation in the energy from port to port could produce an array with fully formed and partially formed apertures. A successive pulse, without other controls, would pass through any fully formed holes and damage the interior wall. The use of differential or incremental energy pulses in accordance with this invention overcomes this problem because the energy applied at a location in the array during each pulse is substantially constant and because the energy in any one pulse is insufficient to penetrate fully the exterior or interior wall.
Thus a balloon catheter structured in accordance with this invention meets the several objectives of this invention. Specifically, the apparatus and method of operation as shown and described with respect to FIGS. 5 and 6A through 6D provide reliable and straightforward balloon production with controlled aperture arrays in the exterior walls of each conduit in a channel balloon. The process is readily adapted for forming multiple arrays, although individual arrays in any given conduit will be separated. Moreover, each array will have an overall area that is insignificant with respect to the total area of VVO 96/30064 PCTrUSr~'~q~61 the exterior wall portion corresponding to a given conduit. Finally, the array of closely spaced holes m;n;m; zes jetting encountered in prior art medication delivering balloons without the requirement o~ additional structures or special materials.
This invention has been disclosed in terms of certain embodiments. It will be apparent that many modi~ications can be made to the disclosed apparatus without departing ~rom the-invention. For example, an array can take any shape and spacing provided the spacing between adjacent ports is suf~icient to maintain the integrity of the exterior wall between those ports. Typically that requires a spacing by the diameter of the aperture or greater. Likewise the number of holes can be varied in the array. Moreover, arrays can be ~ormed in the exterior walls of all the conduits or in only selected ones of the conduits. The process can also be used to ~orm apertures in balloons of a conventional concentric form as well as channel balloons. Therefore, it is the intent of the 20 appended claims to cover all such variations and modifications as come within the true spirit and scope o~
this invention.

Claims

1. A medical device for intravascular delivery of medications to tissue surrounding a vessel, said device comprising:
(A) an inflatable balloon defined by interior and exterior walls extending along an axis, (B) an axially extending conduit disposed between said interior and exterior walls extending substantially the entire length of said balloon, said exterior wall thereby having a given area coextensive with said conduit for contacting the vessel tissue, (C) means to inflate said balloon, (D) means to deliver medications to said conduit, and (E) a two-dimensional array of a plurality of ports through said exterior wall from said conduit, said ports being closely spaced axially and circumferentially and each of said ports having a diameter that limits a transfer of medication from said conduit by oozing through said port, the area of said array being significantly less than area of said exterior wall that is coextensive with said conduit and in contact with the vessel tissue.

2. A device as recited in claim 1 wherein each of said ports has a diameter that is less than 100 microns.

3. A device as recited in claim 2 wherein each of said ports has a diameter of about 30 microns.

4. A device as recited in claim 1 wherein each of said ports in said array has a center that is spaced from the center of adjacent ports by a distance equal to at least twice the diameter of said port.

5. A device as recited in claim 1 wherein each of said ports has a diameter of about 30 microns and the center of each port is spaced from the center of adjacent ports by a distance of about 60 microns.

6. A device as recited in claim 1 wherein said array comprises a plurality of rows of ports parallel to each other and extending along the length of said device.

7. A device as recited in claim 6 wherein the ports in one row are offset with respect to adjacent rows along the length of said device such that the ports in one row are centered between said ports in an adjacent row.

8. A medical device for the delivery of medications to tissue surrounding a vessel organ in the body, said device comprising:
(A) a catheter having a distal end adapted to be disposed within the vessel and having a plurality of lumens therethrough, (B) a hollow, inflatable, balloon defined by interior and exterior walls and having a distal and proximal ends of the balloon and disposed on the distal end of said catheter, the interior of said balloon being in fluid flow relationship with one of said lumens thereby to provide the interior of said balloon with inflation fluids, (C) a plurality of conduits formed intermediate said interior and exterior walls for receiving medications, said exterior wall having a given exterior wall area that is coextensive with each conduit, (D) means for delivering medications through another of said lumens to said conduits, and (E) a two-dimensional array of a plurality of closely spaced ports through said exterior wall from each said conduit, each of said ports communicating with each said conduit having a diameter that limits a transfer of medication from said conduit by oozing through said ports and each said array having an area that is significantly less than the area of said exterior wall that is coextensive with the conduits and in contact with the vessel tissue.

9. A device as recited in claim 8 wherein each of said ports has a diameter that is less than 100 microns.

10. A device as recited in claim 9 wherein each of said ports has a diameter of about 30 microns.

11. A device as recited in claim 8 wherein each of said ports in said array has a center that is spaced from the center of adjacent ports by a distance equal to at least twice the diameter of said port.

12. A device as recited in claim 8 wherein each of said ports has a diameter of about 30 microns and the center of each port is spaced from the center of adjacent ports by a distance of about 60 microns.

13. A device as recited in claim 8 wherein said array comprises a plurality of rows of ports parallel to each other and extending along the length of said device.

14. A device as recited in claim 13 wherein the ports in one row are offset with respect to adjacent rows along the length of said device such that the ports in one row are centered between said ports in an adjacent row.

15. In a medication delivery device for the delivery of medications to an organ in the body wherein the medication delivery device includes a hollow, inflatable, balloon defined by interior and exterior balloon walls and means for defining at least one elongated discrete channel between the balloon walls for receiving the medications, the improvement of a two-dimensional array of closely spaced ports through the exterior wall constructed by positioning an optical mask proximate the exterior wall at a location for the array wherein said optical mask has a plurality of apertures therethrough that correspond to the two-dimensional array, directing a sequence of laser pulses toward said optical mask thereby to enable energy in each laser pulse to pass through the apertures, the energy of each laser pulse being maintained to remove only an incremental portion of the exterior wall in register with each aperture, and monitoring the interior wall to determine the impingement of laser energy thereon thereby to terminate the sequence of laser pulses.

16. A medication delivery device as recited in claim 15 wherein the laser energy is supplied from an excimer laser and the energy in each pulse is about one millijoule.

17. A medication delivery device as recited in claim 16 wherein said sequence includes less than 25 laser pulses.

18. A medication delivery device as recited in claim 17 wherein said sequence includes a number of pulses in the range from 10 to 20 and the apertures through said optical mask have a diameter of about 30 microns.