CA2081666C - Internal tissue medication permeating apparatus and method - Google Patents

Internal tissue medication permeating apparatus and method

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Publication number
CA2081666C
CA2081666C CA002081666A CA2081666A CA2081666C CA 2081666 C CA2081666 C CA 2081666C CA 002081666 A CA002081666 A CA 002081666A CA 2081666 A CA2081666 A CA 2081666A CA 2081666 C CA2081666 C CA 2081666C
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Canada
Prior art keywords
catheter
balloon
liquid
patient
shaft
Prior art date
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Expired - Fee Related
Application number
CA002081666A
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French (fr)
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CA2081666A1 (en
Inventor
Andrew Jonathan Feiring
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Individual
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Individual
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Publication of CA2081666A1 publication Critical patent/CA2081666A1/en
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Publication of CA2081666C publication Critical patent/CA2081666C/en
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Expired - Fee Related legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/104Balloon catheters used for angioplasty
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F11/00Methods or devices for treatment of the ears or hearing sense; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0434Cuffs
    • A61M16/0436Special fillings therefor
    • A61M16/0438Liquid-filled
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0475Tracheal tubes having openings in the tube
    • A61M16/0477Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids
    • A61M16/0481Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids through the cuff wall
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/20Applying electric currents by contact electrodes continuous direct currents
    • A61N1/30Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
    • A61N1/303Constructional details
    • A61N1/306Arrangements where at least part of the apparatus is introduced into the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/105Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M2037/0007Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin

Abstract

A method and apparatus for selectively treating a targeted portion of internal body tissue of a patient by providing a balloon (14) with an internal electrode at a point adjacent the tissue to be treated and electrodes (13) external to the patient's body.
Fluid containing ionic molecules is supplied to the balloon (10) between the internal electrode and the external electrodes. An electric field radiating outwardly from the internal electrode to the external electrodes (13) is created so that said fluid flows outwardly from the balloon (10) through pores (30) away from said internal electrode into the tissue to be treated.

Description

W091/16945 PC~/US91/03~1 "Internal Tissue Medication Penmeating Apparatus and Method"

FIELD OF THE INV~N-1 ION

The present invention relates to techniques and devices for inducing the permeation of medication and the like into body tissue and organs.

BACRGROUND OF THE INV~N ~ ION

Iontophoresis has been utilized for many years for delivering medication into the body of a patient to diagnose and treat various ailments. Another related procedure iontohydrokinesis has been proposed for similar use. For example, iontophoresis has been utilized to deliver Pilocarpine medication to diagnose cystic fibrosis, for the permeation of insulin through the skin, the introduction of steroids into joints to treat arthritis, to anesthetize the eardrum or eye, to treat plantar warts with sodium salicylate, to treat canker sores in the mouth with steroids, to treat W O 91/16945 2 0 81~ 6 Ç PC~r/US91/03091 Peyronie's disease (the fibrosing of the penis), and to deliver proeainamide aeross the heart during experimental open chest surgery in dogs.
Iontophoresis involves the transportation of medieation in the form of naturally eharged or ionic molecules by creating an electric field which acts as a driving force to eause the molecules to advance toward an oppositely charged pole. More particularly, iontophoresis is defined in Steadman's O Medical Dictionary as the introduction by means of electric current of ions of soluble salts into the tissues of the body for therapeutic purposes;
alternatively, the facilitated entry of electrically charged drugs into the surface tissue by application of an electric current. For example, if fluid having charged molecules is placed on a patient's skin and a properly oriented electric field is developed, the fluid will permeate the patient's skin. Where the molecules normally are uncharged, they may be rendered ionic by lowering or raising the pH of the carrying fluid.
The principle is similar for iontohydrokinesis which may be used to deliver unch~rged, non-polar molecules of medication. In iontohydrokinesis, water, which has naturally charged molecules and containing noncharged or non-polar molecules of medication, is transported into the tissue of a WO91/16945 2 0:816 6 6 PCT/US91/03091 patient. By subjeeting the mixture to an eleetrieal field, the water moleeules will earry the 1mcharged partieles with them as they flow from one pole towards the other.
Typically the technique for developing the electric field in iontophoresis or iontohydrokinesis involves plaeing both positive and negative eleetrodes externally of the patient's body or the speeifie organ that is to be treated. Consequently, the teehniques do not lend themselves to targeted, loealized treatment of internal body organs.
Generally, when it has been desired to use the proeedure loeally on an internal organ, it has been neeessary to expose the organ surgieally. Onee the organ is exposed, the eleetrodes can be placed on opposite sides of the organ, as in the case of the delivery of proeainamide to the heart during open ehest surgery, diseussed above. Sueh a surgieal teehnique for loealized treatment of internal organs has obvious drawbaeks such as trauma to the patient and other disadvantages and risks of general surgery. It would be desirable, therefore, to provide a less invasive teehnique for delivering an effective concentration of medication locally to an internal organ. For example, it would be desirable to deliver concentrations of selected eompounds to the wall of an artery as an adjunct to angioplasty, w091/l694~ 2 0 8 1 6 ~ 6 ' '~ PCT/US91/0~91 a proeedure to enlarge a narrowed (stenosed) portion of an artery by plaeing a balloon in the stenosis and inflating the balloon to dilate the stenosis, thus improving blood flow through the artery.
A signifieant problem in angioplasty is the relatively high rate of restenosis (approximately 30%) after performing an initial angioplasty. It has been suggested that restenosis may be eontrolled or possibly prevented by applying suitable medieation to the wall of the artery in the region of the angioplasty. For example, among the faetors thought to eontribute to ineidenee of restenosis is the uneontrolled proliferation of smooth musele eells in the arterial wall, as a eonsequenee of the angioplasty. To that end, it has been proposed that a eoneentrated dose of suitable medieation, such as heparin, be applied to a loeal region of an artery and foreed into the wall of the artery under pressure. A catheter adopted for that purpose is disclosed in U.S. Patent 4,636,195 issued January 13, 1987 to Wolinsky. The Wolinsky patent describes a catheter having a pair of spaeed balloons mounted on the distal end of the eatheter. The catheter is inserted into the patient's arteries and is navigated to the site of the angioplasty. The catheter is positioned so that the balloons embrace the region of the angioplasty. Suitable medication, WO91/16945 2 0 8 1 6 6 6 ~CT/US91/03091 such as heparin, then is forced, under pressure, into the space between the inflated balloons to force the medication, under pressure, into the wall of the artery.
It is among the objects of the invention, therefore, to provide a minimally evasive technique for delivering an effective concentration of medication or the like locally to an internal organ of the patient.
SUMMARY OF THE INV~N 1 ION

In accordance with the invention, medication or the like is cause to permeate through the tissue of a specific, targeted internal body organ using iontophoresis or iontohydrokinesis technigues.
Practising the invention involves placing one or more electrodes externally of and circumferentially about the patient. Another electrode is inserted, as by a catheter, into the target organ or a selected portion of the organ. While an electric field is developed between the internal and external electrodes, medication having charged or polar molecules (iontophoresis) or ~1nchArged molecules coupled with polar molecules, such as water (iontohydrokinesis), then may be delivered directly to the internal organ at a location between the WO91J16945 2 ~ 8 16 6 ~!~ PCT/US91/03091 internal and external eleetrodes. The eleetric field will eause the medieation to permeate radially outwardly from the internal electrode toward the external electrodes thus causing the medication to permeate through the target organ.
One embodiment of the invention adapted for use in treating the wall of a blood vessel or other body lumen employs a balloon catheter which may be placed in the blood vessel and positioned by inflating the balloon in the speeific portion to be treated. The catheter earries an internal eleetrode which may be in the form of an insulated wire extending through the eatheter and terminating in the exposed eleetrode inside the balloon. The balloon which also aets as a drug reservoir has a plurality of regularly spaced minute pores. The interior of the inflatable balloon is in eommunication with a source of liguid medication by a lumen that extends through the eatheter from the proximal end where the lumen can be eonneeted to the liquid source. Medieation (ionie or coupled to a charged liquid molecule) is delivered to the balloon and weeps through the minute pores during generation of the electric field. When used adjacent the heart, the electric field may be pulsed on during systole to reduce the risk of inducing cardiac arrhythmia.

WO91/16945 : 2 0 ~16 ~ PCT/US91/03~1 It is among the objects of the invention to provide a method of inducing permeation of medication to a selected internal organ or body tissue.
Another object of the invention is to provide a method for treating a body organ with a substantial concentration of medicine or drugs, without systematically exposing the patent to such a concentration.
A further object of the invention is to provide a method and apparatus for permeating the wall of an artery with suitable medication so as to reduce the risk of restenosis after angioplasty as well as a primary treatment of obstructive coronary artery disease.
Another object of the invention is to provide a selective medication delivery technique for internal organs using principles of iontophoresis and iontohydrokinesis.
A further object of the invention is to utilize external electrodes and an electrode located in a targeted body organ for creating an electric field to induce the permeation of medication into the targeted body organ by iontophoresis or iontohydrokinesis.

WO91/16945 2 0 ~ 1 & 6 3 PCT/US91/03091 DESCRIPTION OF THE DRAWINGS

The foregoing and other objeets and advantages of the invention will be appreciated more fully from the further deseription thereof, with reference to the aeeompanying drawings wherein:
FIG. l is a diagrammatie illustration of a system for praetising one embodiment of the invention ineluding a balloon eatheter having a permeable balloon and a "driving" eleetrode, and an external "return" eleetrode;
FIG. 2 is a eross-seetional illustration of the eatheter shaft in a two lumen embodiment of the invention;
FIG. 2A is a eross-seetional illustration of the shaft of the eatheter in a three lumen embodiment of the invention in whieh the balloon is in eom~1~nieation with two lumens ineluding an inlet lumen and a return lumen;
FIG. 3 is an enlarged diagrammatie illustration of the eatheter in aeeordanee with the invention illustrating the balloon and eleetrode eonfiguration at the distal end of the eatheter;
FIG. 3A is an illustration similar to FIG. 3 illustrating the distal end of the catheter or a three lumen device of the type illustrated in FIG.
2A; and WO91/1694~ ~ . PCT/US9t/03~1 .

FIG. 4 is a diagrammatic illustration of a patient having multiple electrodes placed circumferentially outside the body.

DESCRIPTION OF THE PREFE'RRED E~ODIM~TS

FIG. 1 illustrates apparatus as it may be used in the practice of the in~ention. The apparatus includes a catheter 10 and an external return electrode 13 Although only one external electrode 13 is illustrated in FIG. 1, multiple external electrodes preferably are employed and are placed circumferentially about the patient as illustrated in FIG. 4.
As illustrated diagrammatically in FIG. 1, the catheter includes an elongate flexible shaft 12 that may be formed from any of a variety of polymeric materials commonly used in catheter manufacture.
The catheter 10 has a proximal end (to the left in FIG. 1) that remains outside of the patient and a distal end (to the right in FIG. 1) that is inserted into the patient. An inflatable and deflatable balloon 14 is mounted to the distal end of the catheter shaft 12. The proximal end of the catheter shaft may branch out into two or three proximal legs including an inflation/deflation leg 16 and a ~ 25 guidewire leg 18 (in the two leg embodiment) and a A

2 0 81~ ~ 6 PCI'/US91/03091 WO 91/16945 . ' 1 ~-q~ ~ 7 ~

third fluid return leg 20 (in the three leg embodiment). It should be noted that in the two leg embodiment, return leg 20 is omitted, all three legs 16, 18, 20 being shown in FIG. 1 for convenienee of illustration. The catheter may have two or three lumens.
FIG. 2 illustrates, diagrammatically, the cross-sectional configuration of the eatheter shaft 12 in a two leg, two lumen embodiment. In this 0 e~hoAiment, the catheter shaft 12 includes an inflation lumen 22 and a guidewire lumen 24. The inflation lumen 22 is in co~m~nication with the tubular inflation leg 16 which, in turn, is conneeted to an inflation/deflation device 26 which may be any of a variety of such devices as are commercially available. The distal end of the inflation lumen 22 opens into the interior of the balloon 14, as indicated diagrammatically at a port 28 in FIG. 3. Thus, the balloon 14 may be inflated and deflated through the lumen 22 by operation of the inflation/deflation device 26. As will be described in further detail, the balloon is formed to inelude a multiplicity of minute pores 30 which may be substantially regularly spaced about the surfaee of the balloon 14. The pores 30 serve to deliver the medieation to the wall of the organ being treated. The other, larger lumen 24, is WO91/16945 2~0 S 1~ 6 5 PCT/US91/03~1 connected to the tubular guidewire leg 18 and serves to receive a guidewire 32. The guidewire lumen extends fully the length of the catheter shaft, and terminates at a distal exit orifice 34. The guidewire 32 thus can be projected distally beyond the distal end of the catheter shaft and may be manipulated to facilitate placement of the catheter in the body lumen as will be appreciated by those familiar with the art. For example, the guidewire may be of the steerable type as described in further detail in U.S. Patent 4,545,390 (Leary).
In order to develop the electrical field necessary for iontophoresis or iontohydrokinesis, the catheter includes a conductor that extends from the proximal end of the catheter to and into the balloon 14. In the illustrative embodiment, the conductor is in the form of an insulated wire 36 that may merge into the inflation/deflation lumen 22 at the proximal end of the catheter and may extend distally through the lumen 22 and into the balloon.
The distal portion of the conductor 36 disposed within the balloon 14 may be uninsulated to define the inner, driving electrode. Preferably, the driving electrode is wrapped helically about the portion of the shaft 12A that extends through the balloon 14. The helical configuration of the electrode enh~nces uniform radial distribution of WO91/16945 2 0 8 1~ PCT/US91/03~1 the electrical field. In alternative embodiments, the conductive wire may be conducted to one or more metallic band electrodes extending about the shaft within the balloon, for example, as to a mid-balloon marker band 38. Alternately, the electrode may be in the form of a wire mesh within the balloon about the catheter shaft.
In the three leg embo~;ment of the catheter, the catheter includes three lumens as indicated in FIG.
2A. In this embodiment, the catheter shaft 12A is formed to include an inflation lumen 22A, a guidewire lumen 24A and a return lumen 40. The prnYi~?l end of the return lumen 40 is connected to the tubular return leg 20 at the proximal end of the catheter. The distal end of the return lumen 40 opens into the interior of the balloon at a port 42 illustrated in FIG. 3A. As will be described further below, the three leg embodiment enables a continuous flow of liquid into and out of the balloon 14.
The size of the balloon 14 is selected so that when inflated it will be slightly larger than the body lumen into which the catheter is to be inserted. This is desirable in order that the balloon may be pressed lightly against the inner luminal surface of the targeted organ so that medication that is emitted from the balloon will be WO 91tl6945 . . PCr/US91/03091 applied directly and intimately against the inner luminal surface of the organ. The minute pores 30 may be of the order of 400 angstroms to 25 microns in diameter. The balloon 14 preferably is made of an inelastic polymeric material of the type used in balloon angioplasty catheters as will be familiar to those skilled in the art. For example, the balloon may be formed ~rom polyethylene terephthalate. The inelasticity of the balloon material serves to prevent the pores 30 from becoming too large during inflation of the balloon, thus undesirably varying the flow rate of the medication.
The external return electrodes 13 and the internal driving electrode are connected to a direct current source 44. In order to reduce the risk of disrupting the patient's heart rhythm when the electrodes are in the region of the heart, the current to the electrodes preferably is pulsed on during the systole phase of the cardiac pumping action and off during diastolic phase.
In use, the external electrodes 13 are positioned circumferentially about the patient. The catheter 10 is inserted into the patient and manipulated into the desired location of the desired body lumen. The catheter 10 may be positioned by any one of numerous well-known methods such as the use of guidewire 32. Once the catheter 10 has been ,,~
~.

WO91/16945 -. .; PCT/US91~0309i advanced so that the balloon 14 is at the desired location, the balloon 14 is inflated to fill the body lumen and seal the balloon against the inner surface of the body lumen under light pressure.
Preferably, the balloon is pressurized not substantially more than approximately 150 mmHg.
Power to the electrodes is provided to develop an electric field radiating outward from the inner driving electrode to the outer return electrodes 13. Due to the charged nature of the medication or the water with which the medication may be mixed, the medication flows radially outward a}ong the lines of the electric field, thus permeating the targeted tissue located radially outward from the balloon 14. The medication thus is localized to the target organ.
The external electrodes are positioned, as shown in FIG. 4, about the patient's exterior so that the medication will flow radially outward in all directions. The charge applied to each of the electrodes may be varied when the internal electrode is not located centrally inside the patient so that the field is of equal strength through 360~. The current strength, duration of current application and location of the external electrodes may be varied to further focus the flow of medication.
Patch electrodes, which are known in the art, may be A

WO91/16945 ~ ~ O ~ 1 6 6 ~ PCT,US9l,03~l used as the external electrodes. Thus, the direction and uniformity of dispersion and permeation of the medication may be controlled. The polarity of the inner driving and external return electrode is selected with reference to the sense of the ionic compound to assure dispersion in a radially outward direction.
The method and apparatus of the present invention provide numerous advantages. By utilizing the electrode configuration of the present invention, specific internal locations of a patient may be targeted for treatment with a particular medication. Furthermore, the permeation of the medication into the body tissue external the balloon is induced by creating an electric field and not by increasing pressure on the liquid in the balloon 14. Consequently, mechanical stress to the body lumen is kept at a minim1-m. By introducing the medication to the balloon and only allowing it to pass radially outward through the balloon pores, an excessive concentration of medication is not introduced to the patient.
While the foregoing method and apparatus are applicable to a wide variety of body organs and lumens, they have particular use in blood vessels such as arteries. The catheter lO shown in FIG. l may be used in the primary treatment of a lesion PCT/~S91/0~91 WO91/16945 ~ '2 0'8'1'6 6 ~

(stenosis) with an appropriate medication to reduce the size of the lesion or to prevent restenosis after an angioplasty. In primary treatment of a lesion, the catheter l0 is inserted into an artery until the balloon 14 is positioned against the region of the dilated stenosis. A suitable liquid medication (ionic or coupled to a polar carrier molecule) is infused into the balloon 14 to inflate the balloon and seal it against the luminal surface. An electric field then is induced between the internal drivi~ ~electrode and the external return electrodes~13jso that the medication flows radially outward t~ough the pores 30 of the balloon 14 and into the arterial wall to brea~ down the stenotic material and cause reduction in the size of the stenosis.
When used for treating an artery after a conventional angioplasty to prevent restenosis, an antirestenosis drug, such as heparin, is used to inflate the balloon 14. Once the electric field has been induced, the heparin or other appropriate medication will flow outwardly and permeate the arterial wall. The degree to which the medication permeates the wall can be controlled by varying the 2s strength of the electric field and the length of time that the electric field is maintained. In the illustrated catheter, the inflation of the balloon ~ - 17 -14 shuts off blood flow through the artery during the procedure.
The present method may be employed in an autoperfusion catheter of the type described in U.S. Patent 4,581,017 (Sahota) to allow blood flow through the catheter to distally perfuse the artery while the balloon is inflated. As described in that patent, an opening is provided in the catheter shaft wall proximally of the balloon to allow blood to perfuse through the catheter distally of the balloon.
It sometimes may occur that the ionic charge of the molecule may change during the procedure, for example, if the pH
of the fluid changes. Such pH change may result from interaction of the liquid with the electrode as may be a function of the duration of the procedure. In order to avoid adverse changes in pH, the liquid may be aspirated periodically from the catheter and replaced with fresh liquid. This procedure may be used with the two lumen configuration described above and illustrated in FIGS. 1 and 2. Alternately with the three lumen embodiment, represented by FIG. 2A, a continuous flow of liquid may be established through the balloon, flow of liquid being toward and into the balloon through the inflation lumen 22A and out of and away from the balloon through the return WO 91/16945 2 0 8 1 6 6 ~ PCT/US9l/03091 . , ~. .

lumen 40. The return leg 20 at the proximal end of the eatheter 10 preferably is provided with a variable flow resistor 46 by which the baek pressure of the returning outflowing liquid may be controlled. By operating the inflation deviee and variable restrictor 46, the pressure developed within the balloon and rate of continuous flow through the system may be controlled as desired.
Thus, I have described the invention by which medication may be applied selectively to a targeted internal organ or body lumen, such as an artery. It should be understood, while the invention has been described with regard to treatment of tissue adjaeent a body lumen, the invention may be practieed in any loeation where it is desired to apply medication to a vessel or organ having a lumen accessible by a eatheter. For example, the apparatus may be utilized to treat the heart or coronary arteries. The catheter may be passed into a lumen in a partieular organ or may even be inserted into a lumen formed in an organ or tumor for the express purpose of reeeiving the eatheter.
It should be understood that the foregoing deseription of the invention is intended merely to be illustrative thereof and that other embodiments, modifieations and equivalents may be apparent to WO 91/16945 2 0 8 1 6 ~ Pcr/usg1/o3091 those skilled in the art without departing from its spirit.
Having thus described the invention, what I
desire to claim in the letters patent is:

Claims (12)

WE CLAIM:
1. An apparatus for selectively inducing the permeation of liquid to a targeted portion of internal tissue in the body of a patient comprising:
at least one external electrode positioned outside of the patient's body;
a catheter having an elongate shaft placeable into an artery of the patient in the region of a stenosis, the catheter having proximal and distal ends, means extending along the shaft for delivering said liquid from the proximal to the distal region of the catheter and for emitting said liquid from the catheter;
an internal electrode carried by the catheter at the distal end of the catheter;
conductor means extending through the catheter shaft and being electrically connected to the internal electrode, the proximal end of the conductor being connectible to a source of electrical energy;
means for supplying a fluid to the distal end of the catheter to a location in the body adjacent the stenosis, wherein the fluid includes a compound adapted to treat the region of the stenosis; and means for inducing an electric field between said internal electrode and said at least one external electrode so that the fluid emitted from the distal end of the catheter will flow in a direction extending from the internally placed electrode outwardly toward the external electrode, and to the location adjacent the stenosis.

- Page 1 of Claims -
2. An apparatus as defined in claim 1 further comprising a plurality of external electrodes adapted to be positioned circumferentially about a portion of the patient's body.
3. An apparatus as defined in claim 1 wherein the means for emitting said fluid comprises a flexible, inflatable balloon mounted to the distal end of the catheter shaft, the balloon having a plurality of pores formed therethrough to enable the liquid to flow out of the pores.
4. An apparatus as defined in claim 3 wherein the balloon is formed from a substantially inelastic material which prevents growth of the pore size as the balloon is inflated.
5. An apparatus as defined in claim 3 or 4 wherein the catheter further comprises a lumen extending through the catheter shaft and terminating in an outlet distally beyond the balloon and means for directing blood flow through the lumen and out of the distal outlet to permit distal perfusion of blood during inflation of the balloon.
6. An apparatus for selectively inducing the permeation of liquid to a targeted portion of internal tissue in the body of a patient comprising:
means for generating a polar electric field in which one pole of the field is disposed internally of the targeted portion of the tissue and the return pole is external of the targeted portion of the tissue;
means for supplying liquid having polar molecules to a location in the body adjacent the targeted portion of the tissue;
means for polarizing said electric field with respect - Page 2 of Claims -to the polarization of the polar molecules such that the electric field will induce flow of the polar molecules through the targeted portion of the internal tissue toward the other pole of the field; and means for pulsing the electric field in phase with the patient's cardiac rhythm.
7. An apparatus as defined in claim 6 wherein the means for emitting the liquid from the catheter comprises a flexible, inflatable balloon mounted to the distal end of the catheter shaft, the balloon having a plurality of pores formed therethrough to enable the liquid to flow out of the pores.
8. An apparatus as defined in claim 7 wherein the balloon is formed from a substantially inelastic material.
9. An apparatus as defined in claim 7 or 8 wherein the catheter further comprises a lumen extending through the catheter shaft and terminating in an outlet distally beyond the balloon, the lumen being adapted to receive blood proximally of the balloon and to enable blood to flow through the catheter and be emitted distally of the balloon to permit distal perfusion during inflation of the balloon.
10. A catheter for selectively inducing the permeation of liquid to a targeted portion of a blood vessel in the body of a patient comprising:
an elongate flexible shaft dimensioned for insertion in to the human vascular system, the shaft having proximal and distal ends;
a balloon for emitting the liquid from the catheter;
a first lumen extending along said shaft for - Page 3 of Claims -delivering the liquid from the proximal end of the catheter to the distal region of the catheter;
a second lumen extending through said shaft and terminating in an outlet distally beyond said balloon, said second lumen being adapted to receive blood proximally of said balloon and to enable blood to flow through the catheter and be emitted distally of said balloon to permit distal perfusion during inflation of said balloon;
an internal electrode carried by the catheter at the distal end of the catheter; and a conductor extending through said shaft sand being electrically connected to said internal electrode, the proximal end of the conducting being connectible to a source of electrical energy.
11. Use of an apparatus according to claim 1, 2, 3, 4, 5, 6, 7, 8 or 9 for selectively inducing the permeation of liquid to a targeted portion of internal tissue in a body of a patient.
12. Use of a catheter according to claim 10 for selectively inducing the permeation of liquid to a targeted portion of internal tissue in a body of a patient.

- Page 4 of Claims -
CA002081666A 1990-05-07 1991-05-06 Internal tissue medication permeating apparatus and method Expired - Fee Related CA2081666C (en)

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US07520033 US5236413B1 (en) 1990-05-07 1990-05-07 Method and apparatus for inducing the permeation of medication into internal tissue
US520,033 1990-05-07
PCT/US1991/003091 WO1991016945A1 (en) 1990-05-07 1991-05-06 Internal tissue medication permeating apparatus and method

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US5425703A (en) 1995-06-20
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US5810763A (en) 1998-09-22
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