JP2002159580A - Ion impregnation device and using method thereof - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a device for efficiently performing a treatment by ion impregnation to a human body, particularly, to eyeballs without loss of medicines. SOLUTION: This ion impregnation device 20, 120 comprises a housing element 22, 122, a current distributing element 24, 124 connected to the housing element, a chemical housing element 26, 126 connected to the current distributing element, and a barrier element 28, 128 set in contact with the tissue of the body of a patient. The barrier element has a shape for reducing the flow of the outside current. In another embodiment, the current distributing element is flexible and supported by the housing element, and the chemical housing element is conformable, and connected to the housing element. In the other embodiment, the flexible and conductive current distributing element is constituted so as to cooperate with the housing, and the chemical housing element is constituted so as to be filled with chemicals and dilute the filled chemicals by the effect of the current.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an apparatus for administering a substance to the eye, and a method of using the apparatus.
And a method using the ion infiltration apparatus.

[0002]

2. Description of the Related Art During the treatment of the eye, it is necessary to administer a drug to the eyeball.
The requirements for administering drugs to the eye vary. For example, various concentrations of the drug are needed in the vitreous inside the eye to treat specific pain. However, for other pathological conditions, it is effective to administer and disperse the drug over the entire sclera or inside the scleral tissue. Also, other treatments require the injection of an anesthetic into the corneal tissue prior to surgery, such as a corneal incision. Thus, in some treatment situations, it may be necessary to administer the drug over a large area, or to concentrate the drug in a small area.

[0003] The traditional method of administering drugs to the surface of the eye, whether to treat a disease or to aid in diagnosis, is by eye drops. Generally, the lower eyelid is held away from the sclera of the eye and a drop of drug is introduced into the gap formed between the eyelid and the sclera. During this treatment, care must be taken to prevent eye drops or human fingers from contacting the eyeballs to avoid contamination. In this treatment, various forms of drugs such as antibiotics, corticosteroids, and antihistamines are administered to the eye. In addition, eye drops have been used to administer drugs to treat glaucoma and drugs that open or close the pupil. For example, when performing an eye examination, an ophthalmologist instills tropicamide or phenylephrine into a patient to open the pupil. By doing this, the ophthalmologist can see the lens completely and check for any lesions. Furthermore, in cataract surgery,
The doctor makes the same instillation on the surface of the eyeball many times, opening the pupil and exposing most of the anterior surface of the lens. In addition, surgeons use drops for local anesthesia instead of local or general anesthesia using a needle.

[0004] Disadvantageously, the administration of the medicament through the use of eyedrops can be contaminated, especially when many people use the same eyedropper. Furthermore, when a person inadvertently touches the eyedropper with a finger, bacteria on the finger attach to the eyedropper. Also, while the drug is required in the vitreous of the eyeball, the eyedropper administers the drug only to the surface of the eyeball and the drug passes through the layers of the eyeball. It takes a long time for the drug to pass through the vitreous, and therefore, administration of the drug by eye drops diminishes its effect.

[0005] When it is necessary to administer a drug beneath the surface of the eye, it is common to utilize injections. This is usually done by inserting a needle into the tissue surrounding the eye or into the sclera of the eye. If the drug is injected into any area, the drug will be directed into the vitreous or other surrounding tissue or into other parts of the eye.

However, the use of hypodermic needles has drawbacks.
Drug injection is invasive, inconvenient, and sometimes dangerous because of the sharpness of the needle. When the doctor inserts the injection needle into the surrounding tissue, a slight increase in the applied force causes a hole in the eyeball, detaches the retina, and causes various problems. Furthermore, when inserting a needle near or into the eyeball of any type of syringe, many are anxious about using the needle.

Another relatively small method used to administer drugs is known as iontophoresis. Most fundamentally, iontophoresis applies an electromotive force to drive ionic chemicals into tissue so that it is absorbed by adjacent tissues and blood vessels. Generally, a first portion having an ionic drug solution is contacted with a portion of the tissue to be subjected to iontophoresis.
This procedure is performed by placing a bioelectrode. A second bioelectrode is placed on a part of the body near the first bioelectrode, a sufficient voltage is applied, current is passed through the tissue, and an electrical circuit is completed between the first and second bioelectrodes. When an electric current is applied, the ionized drug molecules move through the tissue under the action of the second bioelectrode.

[0008] A similar processing method is also applied to the eye ion permeation method. Traditionally, ocular iontophoresis devices are either of two types: cold eye cup devices, or applicator probes. Old-fashioned cold-eye cup devices are formed by hemispherical elements. Usually, the hemispherical element is hollow, and an electrode protrudes from the top of the hemispherical element. During ion penetration, a cold eye cup device is filled with the drug solution and the cold eye cup is placed on the eyeball. When a voltage from a power supply is applied, current flows from the electrodes in the hemispherical element to the surface of the eye. Similarly, drug ions flow from the cathodic bioelectrode in the hemispherical element to the anodic bioelectrode or vice versa, thereby forcing the drug to flow into the patient's eye.

[0009] An alternative iontophoretic device for the eye uses an applicator probe. The electrodes of the applicator probe extend into the end of the drug-loaded probe. The end of the probe is placed in the patient's diseased area, and when current is applied, the drug moves from the end of the probe into the patient's tissue.

This conventional eye ion penetrating apparatus has a number of problems. For example, an applicator probe device must accurately and continuously hold the probe to the patient's eye. Unfortunately, this procedure can take a long time when ion permeation throughout the eyeball is required. In addition, if the applied force is too large, the current will be very large, or if the contact is maintained for too long, the patient's eye will burn, leaving trauma on the surface of the eye.
In addition, in the case of a cold-eye cup-shaped device, if the probe is too long or incorrectly set, there is a risk of scratching the patient's eyeball. Further, the adaptability of the cold-eye cup is limited, and the size and curvature of the eyeball change, so that the medicine put in the cold-eye cup may leak from under the edge of the cold-eye cup. In addition, foreign substances, such as tears, saline, or other impurities, penetrate into the drug, reducing the drug's potency, ie, its pharmacologic effect. Forcing the cold eye cup against the surface of the eye will reduce the effects of leakage and foreign matter penetration, but will damage the eye due to the forces required for it.

The most important problem with conventional ocular iontophoresis devices is probably that rather than administering the drug to the eye or sclera, the drug is inadvertently delivered to the surrounding soft tissue, including the eyelids, orbits, and the like. Is to put it. Involuntary drug delivery to surrounding tissues is due to the sclera and other eye tissues being wetted with conductive saline or tears.
Physiological saline or tears have significantly lower electrical resistance than the other current paths, and preferentially flow current through surrounding soft tissue.

[0012]

Accordingly, it can be used to administer a drug to any area of the eye, preventing inaccurate current distribution to surrounding tissues and preventing damage to the eye. The resulting ion infiltration device is advantageous.

[0013] It is an object of the present invention to allow the administration of a fixed amount of a drug to the eyeball, and to reduce the efficacy of the drug by selectively administering a fixed amount of the drug to a specific region or a region requiring treatment. It is an object of the present invention to provide an iontophoresis device which can be prevented and reduces the effect of the electrical shunt of the drug on the surface of the eyeball and in the surrounding soft tissue, and a method of its use.

It is also an object of the present invention to prevent the inflow of saline and tears into the drug and drug matrix, prevent contamination of the drug and drug matrix, and administer the drug to tissues surrounding the eyeball. It is an object of the present invention to provide an iontophoresis device which can prevent the occurrence of an ionization and can be held by hand or fixed to a patient by a user, and a method of using the same.

Yet another object of the present invention is to reduce the time required for iontophoresis during the iontophoresis procedure by preventing the possibility of damaging the eye and increasing the effectiveness of drug administration, thereby reducing the time required for iontophoresis. Relieve pain, be flexible,
It is an object of the present invention to provide a disposable or reusable ion infiltration apparatus having a flexible surface to be installed and a method of using the same.

[0016]

To achieve these objects, the iontophoresis device of the present invention comprises a housing element formed to cooperate with the eye. A flexible current distribution element capable of receiving current from a power supply is coupled to the housing element. A drug is loaded into a compliant drug storage element that cooperates with the current distribution element. The drug is released under the action of an electric current. The barrier element has a configuration that provides the barrier element and reduces the flow of current outside the barrier element, thus preventing unwanted migration of the drug.

The ion permeation apparatus of the present invention comprises: (a) a housing element; (b) a current distribution element connected to the housing element; (c) a drug storage element connected to the current distribution element; A barrier element placed in contact with a patient's tissue, the barrier element being configured to reduce a current flow outside the barrier element.

In another aspect, the ion permeation apparatus of the present invention comprises: (a) a housing element; (b) a flexible current distribution element supported by the housing element; And (d) a barrier element configured to reduce the flow of current outside.
Further, in a different aspect, the ion permeation device of the present invention is coupled to (a) a housing element, (b) a flexible conductive current distribution element cooperating with the housing element, and (c) the current distribution element; A compliant drug-containing element filled with a drug; and (d) an annular element having a configuration that reduces external current and assists in selective administration of the drug. .

The method of using the ion infiltration apparatus of the present invention is as follows:
(i) a housing element; (ii) a current distribution element supported by the housing element; (iii) a drug containing element coupled to the current distribution element; and (iv) a form for reducing the flow of current outside. (B) positioning the iontophoresis device at a desired position in contact with the patient's eye, and (c) applying an electric current to the iontophoresis device to apply a current to the patient's tissue. It is characterized in that it comprises a step of forcibly adding a drug. An embodiment of the present invention will be described in detail with reference to the drawings, but the present invention is not limited to this embodiment.

[0020]

DETAILED DESCRIPTION OF THE INVENTION The present invention is directed to an iontophoresis system for use in administering a drug to the eye. The iontophoresis system has an iontophoresis device used to administer the drug to the eye. The ion osmosis device is configured to selectively administer the drug only to the area where the drug is needed. This ion osmosis device can use a bioelectrode having a larger diameter than that which can be used so far for the delivery of medicine. This increased diameter bioelectrode can be used in the penetration of a drug into the eye without loss of the drug. Further, the iontophoresis device has a form that can be easily used by an operator and / or an operator in a fixed position that can communicate with the eye.

As shown in FIG. 1, in general, iontophoresis system 10 has a current source or power supply 12. This power supply 12 is electrically connected by a cable 14 to a dose controller 16. The dose controller 16 is electrically connected to an ion osmosis device 20 by a cable 18. Power supply 12 and dose controller 16 are known in the art and include, but are not limited to, current flow, treatment time, treatment power cycling, treatment intensity, treatment initiation, and / or pause And perform various iontophoretic system characteristics, such as the magnitude of the therapeutic current from the initial current to the steady state drug delivery current.

The power supply 12 and the dose controller 16 are formed as separate units and interconnected by various electrical means such as cables 14, but in a single unit, as shown by dashed lines 19. They may be formed integrally.
Thus, one of ordinary skill in the art will appreciate that
2, the dose controller 16 and the iontophoresis device 2
Various other embodiments and configurations of the method of cooperatively connecting to zero can be envisaged. The following description relates to various forms and embodiments of the iontophoresis device 20 that can be used in conjunction with various power sources and / or dose controllers.

FIGS. 2-5 illustrate an iontophoresis device 20 that can be used to provide localized iontophoresis in specific areas of the body and cooperate with the iontophoresis system. As shown in FIG. 5, an ion permeation apparatus 20 is used as an applicable probe to perform ion permeation into an eye. It is apparent that the iontophoresis device 20 cooperates with a power supply and known elements of the iontophoresis system, such as a dose controller (not shown). Generally, the iontophoresis device 20 includes a housing element 22, a current distribution element 24, a drug containing element 26, and a barrier element 28. Obviously, many other modified ion infiltration devices 20 can also effectively perform the intended function.

According to one aspect of the invention, the housing element 22 includes a first end 32, a second end 34, and a connector recess 36.
Equipped. The housing element 22 has a first end 32 at the second end 3
Preferably it is substantially tubular with a cross section greater than 4.
The first end 32 has a flange 3 installed around its peripheral edge.
8 The flange 38 has a plurality of holes 40 therethrough, through which the current distribution element 24 and the drug containing element 26 are connected. The connector recess 36 is formed substantially through the center of the housing element 22 from the first end 32 to the second end 34. Further, the connector recess 36 extends outward from the center of the housing element 22 and divides the second end 34 of the housing element 22 into two parts. In view of the techniques described herein, those skilled in the art will be able to contemplate various other forms of the housing element 22 and its associated features.

For example, the first end 32 may have the same cross section as the second end 34, or the first end 32 may have a smaller cross section than the second end 34. Housing element 22
Depending on the type of connection required between the connector recess 36 and the user operating device 30, the connector recess 36 can take various forms. For example, a female thread may be provided in the connector recess 36 and interconnected to an associated thread of the user operating device 30.
In another alternative, the connector recess 36 may be tapered so that it can slip fit into the associated tapered user operating device 30. Also, according to the connector used to attach the housing element 22 to the user operation device 30, the second end 3 is formed by the connector recess 36.
4 may be divided into a number of parts. Housing element 22
Various other means of coupling to the user operating device 30 are known to those skilled in the art. Furthermore, the teachings herein will allow those skilled in the art to conceive of various alternative forms of housing element 22 that perform the intended functions.

In general, the housing element 22 is secured so as to securely hold the current distribution element 24, the medicine containing element 26, and, if necessary, the barrier element 28, and to connect these elements to the user operating device 30. Determine the form. Further, the housing element 22 is configured to withstand the forces applied by the user during the iontophoresis operation. The housing element 22 preferably comprises a material that provides sufficient strength, stiffness, and coupling capability for the housing element 22 and that is easily manufactured. Materials of this type cover a range of plastics, such as Teflon, nylon, polyester, polyethylene, and polycarbonate, as well as metals and composites. The housing element 22 is preferably made of polycarbonate plastic.

The current distribution element 24 is connected to the housing element 22. In one preferred embodiment, the current distribution element 24 has a substantially circular member 46 and is disk-like, similar to a washer. The plurality of holes 48 are located near the peripheral edge, thereby connecting the current distribution element 24 to the first end 3 of the housing element 22.
2 can be connected. In addition, the center orifice 50
Through the center of the circular portion 46. With the information provided herein, one of ordinary skill in the art will be able to contemplate various other forms of current distribution element 24.

For example, the current distribution element 24 can have various shapes such as oval, ie, elliptical, rectangular, octagonal, trapezoidal, and the like. The current distribution element 24 is interconnected to the housing element 22 and is fixed to the user operation device 30. In that case, the current distribution element 24 is
A protruding wire that protrudes from the base end 31 of the O and is connected to the medicine containing element 26 can be formed. Further, the current distribution element 24 can be formed so that an external power supply can be electrically connected to the current distribution element 24. Thus, the current distribution element 24 can provide an electrical connection between the housing element 22, the power supply, and the drug containing element 26, and can be of any shape known to those skilled in the art. Therefore, the current distribution element 24 needs to have sufficient strength, rigidity, heat resistance, and conductivity to resist damage when a current is applied. Various other forms of current distribution element 24 are also effective in performing the intended function.

The current distribution element 24 is preferably made of a flexible, current-carrying material. As the material,
For example, aluminum, copper, thin metal films, conductive carbon films, printable conductive carbon films, other printed films, and the like. Preferably, the current distribution element 24 is formed from a plastic sheet or a thin metal film printed on a polyester film. The thickness of this plastic sheet or film can be from about 2 mils,
Range between about 5 mils. This thickness is from about 3 mils,
Preferably, it is between about 4 mils, more preferably about 3 mils thick.

In addition to the dimensions of the current distribution element 24, the current distribution element 24 of the alternative embodiment is disposable or reusable. Thus, various compounds or alloys can be used to provide a cost effective means of delivering current. If pH control is desired, silver (Ag),
Alternatively, a silver chloride (Ag / AgCl) compound can be used.
As a reusable device, the cathode current distribution element 24 is made of Ag.
/ AgCl 2 can be made of a sintered body, which can provide sufficient Cl, for example, for various therapeutic applications. The anode current distribution element 24 is made of solid Ag metal or sintered Ag.
It can be made from particles or inks. Ag or Ag / AgCl for single use disposable ion infiltration equipment
If it is desired, a small amount of Ag or Ag / AgC
l can be adopted. In another embodiment of the present invention, a carbon conductor can be used as the anode current distribution element 24 or the cathode current distribution element 24.

The medicine containing element 26 is connected to the current distribution element 24. In the embodiment of FIGS. 2-5, the drug receiving element 26 includes a generally cylindrical cylindrical portion 52 having a first receiving end 54 and a second receiving end 56. The first receiving end 54 is connected to both the current distribution element 24 and the housing element 22. The first receiving end 54 is the first receiving end of the housing element 22.
It has the same cross section as the end 32. Further, the first receiving end 54
Has a plurality of projections 58 near its peripheral edge, and the projections 58 project from the first accommodation end 54 in parallel to the longitudinal axis of the medicine accommodation element 26. The plurality of protrusions 58 penetrate the plurality of holes 48 and are locked in the corresponding plurality of holes 40. The plurality of projections 58 are formed by the current distribution element 2.
4 to the medicine containing element 26. The drug containing element 26 can have various other configurations that are more effective in performing its intended function.

Generally, the drug containing element 26 is configured to maintain a supply of drug during the iontophoresis operation. Further, the drug containing element 26 conducts current from the current distribution element 24 to the surface with which it is in contact. The medicine containing element 26 needs to have the flexibility not to damage the eye while in contact with the eye, the strength to be elastically deformed during the ion infiltration operation, and the rigidity.

Various other forms of the drug containing element 26 can be devised by those skilled in the art in view of the teachings herein. For example, the cross-section of the drug containing element 26 varies depending on whether the drug containing element 26 is connected to both the current distribution element 24 and the housing element 22 or individually to each one. Drug storage element 2
6 has the same cross-sectional profile as that of the housing 22 or the current distribution element 24. In another alternative, the drug containing element 26 can be conical, with a conical hole extending partially through its center. Current distribution element 2
This conical hole is configured to cooperate with the current distribution element 24 when 4 is fixed to the user device 30 and has the shape of a projecting wire projecting from the proximal end 31 of the user operating device 30. The drug containing element 26 can also have any cross-section or dimension necessary to perform a particular type of iontophoresis, such as being rounded, angled, or sharp. Further, the drug containing element 26 can be
It may have a cross section of only a few millimeters or a few centimeters. This dimension may range from 1 mm to 20 mm. The drug containing element 26 is preferably between about 5 mm and 6 mm.

One example of a material structure capable of performing the function of the drug containing element 26 is the gel sponge-like composite containing matrix described in US Pat. No. 5,586,632 to Lloyd et al., Incorporated herein by reference. Various other materials used to form the drug containment element 26 are also effective in performing the intended function. For example, various reusable or single-use disposable porous core materials, hydrogels, or composite materials can also be used.

For ion penetration into the eye, it is preferred to use a crosslinked hydrogel. This is because the cohesive nature of the crosslinked hydrogel prevents the fibrous material, gel, or residue from remaining on the eye after ion penetration. The use of a crosslinked hydrogel is also advantageous during ion penetration. This is because the fiber material does not abrade or irritate the eye using a crosslinked hydrogel.
If iontophoresis is used instead, such as to treat skin or hair follicles, a gel with a suction or wetting action is preferred. Examples of such materials for substitution are dry spongy matrices impregnated with hydrogels,
And multi-ply crosslinked poly (ethylene oxide) dry matrix.

Depending on the type of medical treatment to be performed, various drugs can be used in the medicine containing element. For example, an anesthetic such as lidocaine is stored in the drug storage element 26. Another example is an oligonucleotide such as a vascular endothelial growth factor (VEGF) inhibitor. Other examples of drugs that can be used include antibiotics, corticosteroids, antihistamines, tropicamide, or phenylephrine. Various other agents may be delivered by use of the iontophoresis device 20.

As shown in FIGS. 2 to 5, the barrier element 28 is connected to the medicine containing element 26. The barrier element 28 has an annular shape having a barrier element body 64, i.e., a donut shape, and the barrier element body 64 has a first recess 66 having an axis coinciding with the axis thereof. . One part of the barrier element body 64 is connected to the medicine containing element 26, and the other part cooperates with a part of the eyeball. Various other forms of barrier element 28 are also effective in performing its intended function.

Generally, the barrier element 28 is
And formed to assist in the selective administration of the drug. To prevent the previously mentioned problem of electrical shunting,
It is the gist of the present invention to perform selective administration during the operation of iontophoresis into the eyeball.

It is believed that when a current is applied to the eyeball, a shunt of the electrical path occurs, while at the same time producing current emission in many directions. In traditional electrical theory, the flow of current, or charge, follows a path along a minimum electrical resistance. In the case of ion penetration into the eye, the surface of the eye is continuously immersed in a saline solution of conductive ions, so tears and the resulting natural saline disperse current across the surface of the eye, Distribute the current in the tissue. It is believed that this effect occurs irrespective of the exact location on the surface of the eye where the current is directed.

Thus, current may flow into the sclera, into the vitreous of the eye, and even into the surrounding fascial tissue, such as the inner eyelid and orbital tissue. Recent studies support this proposal. When attempting to administer a drug compound by transscleral ion penetration, the level of the drug compound was not detected in the vitreous of the eye, and significant blood tissue levels of the drug compound were detected. This suggests that the drug compound, and the current driven flow, diverge from the transscleral flow, or "shunt," and enter soft tissue along the surface of the eye. The barrier element 28 of the present invention is configured to prevent the drug from following the electrical path on the surface of the eye, thereby assisting in the selective distribution of the drug for a particular medical procedure.

Depending on the dimensions of the drug containing element 26, the current distribution element 24, and the housing element 22, and the particular medical procedure being performed, the barrier element 28 may have various configurations. For example, the iontophoresis device 20 may not require the barrier element 28 because the medical procedure may use a shunt of the electrical path to assist in drug distribution. The ion osmosis device 20 may have more than one barrier element 28, thereby creating a sealed area between the first and second barrier elements, making it more efficient and selective. Can be administered a medicament. The barrier element 28 is a triangle,
It can be round, oval, or elliptical. It is apparent from the teachings herein that various other forms known to those skilled in the art may be used.

The barrier element 28 is preferably constructed of a material that is flexible and conforms to the surface with which the barrier element 28 is in contact to form a fluid tight seal, yet is sufficiently resistant to flexing. It is. One type of material that can be used for the barrier element 28 is a soft silicone gel, or other type of silicon compound, that conforms to the surface on which it is installed. For example, a two-piece soft silicone gel of Dow Q7-2218, a silicone elastomer equivalent available from Nusil, a low durometer urethane, and similar materials are useful in constructing the barrier element 28. Preferably, the barrier element 28 comprises a low durometer silicone elastomer gel.

In forming the ion permeation apparatus 20,
It is necessary to connect the above-mentioned elements to one another. There are various ways to join or combine individual elements. For example, the housing element 22 can be ultrasonically bonded, adhesively, screwed, or bolted to the drug containing element 26 and the current distribution element 24. The barrier element 28 is attached to the medicine containing element 26 by using an adhesive or the like.
In accordance with the teachings herein, the various ways of joining the elements of the iontophoresis device 20 to one another can be envisioned by those skilled in the art. Preferably, these elements are connected by ultrasonic waves.

Here, in FIG. 5, the ion infiltration apparatus 20 can be used to perform ion infiltration into the eyeball. In operation, current is applied to current distribution element 24 through connector recess 36. The electric current is supplied to the medicine containing element 26.
And enters the eyeball. As the current travels to the second bioelectrode near the eye, the current is drawn through the eye. When the ion infiltration device 20 is applied to the eyeball, the barrier element 2
8 comes into contact with the eyeball. The barrier element 28 reduces the current flowing along the surface of the sclera or conjunctiva, and thus the barrier element 2
Direct the administration of the drug to the area within the boundaries of 8. As shown in FIG. 4, the ion permeation device 20 has a size similar to the size of the iris of the eyeball. However, various other dimensions are also effective in performing the intended functions described above.

FIGS. 6 to 8 show an ion permeation apparatus 12 for an eyeball.
0 shows another embodiment. The numerous aspects described for ion permeation apparatus 20 also apply to ion permeation apparatus 120.
The ion osmosis device 120 includes a housing element 122, a current distribution element 124, a drug containing element 126, and a barrier element 12.
8 The housing element 122 is substantially cup-shaped,
Cup-shaped first part 132, second end 134, central part 13
8 is provided. As shown in FIG. 8, the cup-shaped first portion 132 has a form that can be comfortably positioned around the eyeball. Furthermore,
The axis of the cup-shaped first portion 132 is offset from the axis of the second end 134, and the central portion 138 extends from the peripheral edge of the cup-shaped first portion 132. The cup-shaped first part 132 has a hole 140 penetrating at the center thereof, through which the eyeball can be approached. From the teachings herein, those skilled in the art will be able to contemplate various other forms that can perform the intended functions.

For example, as shown in FIG.
The part 132 is placed in the eye so that the eyeball is completely covered. However, in another embodiment, the central portion 138 may extend along the longitudinal axis of the cup-shaped first portion 132. Alternatively, the central portion 138 may extend at an angle from the cup-shaped first portion 132. Other forms of housing element 122 are equally effective in performing the intended function.

It is preferred that the housing element 122 be formed from a material that provides sufficient strength, rigidity, and flexibility for connection for the housing element 122 and that is easy to manufacture. The form of this material ranges from plastics such as Teflon, nylon, polyester, polyethylene, and polycarbonate to composites. Preferably, the housing element 122 is made of polycarbonate.

As shown in FIG. 6, the current distribution element 124 has a shape similar to the shape of the inner surface of the cup-shaped first portion 132. The current distribution element 124 has the shape of a segment in which a plurality of conductive extensions 148 projecting from a conductive ring (not shown) are formed. Therefore, the current distribution element 124 has a shape similar to the shape of the inner space 142 of the cup-shaped first portion 132.

In general, the shape of the segments of the current distribution element 124 provides flexibility for spherical objects that is advantageous to the ocular iontophoresis device 120. The plurality of conductive extensions 148 can flex with respect to the conductive ring, and thus conform to the surface of the eye, applying pressure to the drug containing element 126 to place the drug containing element 126 on the surface of the eye. Can be added forcibly. Current distribution element 124
Various other configurations of are also effective in performing the intended function.

For example, the current distribution element 124 is connected to the user operating device 130 (as shown in FIG. 5) and one or more conductive extensions 148 are connected to the connector recess 136.
Through the inner space 142 of the cup-shaped first part 132. In another form, the current distribution element 124 is located within the connector recess 136 and contacts the drug containing element 126. The current distribution element 124 is
The current distribution element 124 may be located at any vertical position in the connector recess 136 as long as the current distribution element 124 has a configuration that makes contact with the current distribution element 124. Various other forms of the current distribution element 124 can also perform the intended function. It will be apparent to those skilled in the art that any type of current distribution element may be used with appropriate modifications to the housing element 122.

According to another embodiment of the alternative embodiment of the present invention, the drug containing element 126 is formed so as to coincide with the internal space 142 of the cup-shaped first part 132.
The cup-shaped member 152 has an internal curved portion cooperating with the surface of the eyeball. The drug containing element 126 has a double concave shape with inner and outer concave curved profiles.
The outer recess is shaped to cooperate with the housing element 122 and the inner recess cooperates with the surface of the eye. The medicine containing element 126 is connected to the current distribution element 124 and the housing element 122.
To allow the drug containing element 126 to conform to the surface of the eye that the drug containing element 126 contacts.
Various other forms of drug containment elements are also effective in performing their intended functions.

For example, the drug containing element 126 is formed with at least one hole cooperating with at least one conductive extension 148. In another embodiment, the drug containing element 12
6 is made of gel, and this gel is inserted into the inner space 142 of the cup-shaped first part 132. In another form, the drug containing element 126 has an annular shape, and the holes 140 allow for continued refilling of the drug containing element 126. Thus, the drug containing element 126 conforms to the surface with which it contacts. With the teachings herein, one of ordinary skill in the art will be able to contemplate various other forms of drug containment elements that may achieve the intended function.

According to another aspect of the alternative embodiment of the present invention, the barrier element 128 includes a cup-shaped barrier 164.
The cup-shaped barrier 164 has a substantially circular cross section. The cup-shaped barrier portion 164 is connected to the lower outer edge of the cup-shaped first portion 132 to form a seal for the eyeball when the cup-shaped barrier portion 164 is installed on the eyeball. Barrier element 12
Various other forms of 8 are also effective in achieving the intended function.

For example, as shown in FIG. 6, in an alternative embodiment, the barrier element 128 includes a cup-shaped barrier 164 and an upper cup-shaped barrier 166. The upper cup-shaped barrier section 166 is connected to the peripheral edge of the hole 140 of the cup-shaped first section 132, and the cup-shaped barrier section 164 is connected to the cup-shaped first section 132.
To the lower peripheral edge of the. By combining
The upper cup-shaped barrier 166 and the cup-shaped barrier 164 form an internal recess that restricts the flow of the medicament such that the first cup-shaped barrier may be provided during certain medical procedures.
The medicine is prevented from entering the inside of the part 132. Medical procedures,
And, depending on the needs of the device, the upper cup-shaped barrier section 16
6 and the cup-shaped barrier 164 may have the same cross section or different cross sections. With the teachings herein, one of ordinary skill in the art can envision various other forms of barrier 128.

FIGS. 9 to 11 show another embodiment of an iontophoretic device 220 for an eyeball. For the ion permeation device 120, many of the features described above also apply to the ion permeation device 220. The ion infiltration device 220 is a housing element 2
22, a current distribution element 224, a medicine containing element 226, a barrier element 228, and a mounting element 270. Each element has the same intended function as described above.

The housing element 222 is formed from two separate pieces, a lower rim 232 and an upper rim 234. The lower rim 232 has a lower circular portion 236 and an arm 238 protruding from a peripheral edge of the lower circular portion 236. The lower rim 232 has an internal taper so that
The first lower end 240 has a smaller diameter than the second lower end 242. The upper rim 234 has a substantially circular circular upper portion 235 shaped similar to the shape of a washer. The upper rim 234 is used to securely hold the drug containing element 226 and the current distribution element 224 on the lower rim 232. From the teachings herein, one of ordinary skill in the art can contemplate various other forms of housing element 222 that perform the intended functions.

For example, the lower rim 232 has a flange 244
And the flange 244 is provided on the lower rim 2
The lower rim 232 protrudes from the peripheral edge of the lower rim 232 in parallel to the longitudinal axis of the rim 32. The flange 244 connects directly to the upper rim 234 or to a flange formed on the upper rim 234 and provides a current distribution element 224, a drug containing element 226, a barrier element 228, and an alternative mounting element 270.
Is securely held. The connection is made by ultrasonic bonding, adhesives, or other known bonding techniques known to those skilled in the art. Various other configurations of the upper rim 234 and the lower rim 232 may also perform their intended functions.

For the housing element 222, a material that provides sufficient strength and rigidity and is easily manufactured,
Preferably, an upper rim 234 and a lower rim 232 are configured. Material types are plastics such as Teflon, nylon, polyester, polyethylene, and polycarbonate, and composites. Preferably, the upper rim 234 and the lower rim 232 are made of polycarbonate.

The current distribution element 224 is connected to the housing element 22
Connect to 2. The current distribution element 224 has a conductive ring portion 246, and the conductive ring portion 246 has a plurality of conductive extension portions 248 protruding from an inner peripheral edge thereof. The plurality of conductive extensions 248 project toward the center of the conductive ring 246,
It has a form that bends when a force is applied. Thus, during ion penetration, the current distribution element 224 can conform to the surface of the patient's eye. Further, the current distribution element 224 is
Has an insulating portion 238 protruding from the peripheral edge of the rim. In one form, the current distribution element 224 is formed from a printed film having a metal portion printed on the surface. Various other forms of current distribution element 224 may also perform their intended functions.

For example, the current distribution element 224 may have a single conductive extension 248. Housing element 22
2, based on the drug containing element 226 and the barrier element 228, the current distribution element 224 can have other dimensions and shapes. If the housing element 222 is rectangular, the current distribution element 224 is also rectangular. Other forms are also effective in performing the intended function.

The current distribution element 224 is a thin metal film,
Alternatively, it is preferable to manufacture it from an acetate film having a metal substance printed on the surface. Other materials, such as metals, conductive materials, printed plastics, or films, etc., are also effective in performing the intended function. Current distribution element 2
It is preferable that 24 is made of a polyester film. The thickness of the plastic sheet or film ranges from about 2 mils to about 4 mils. A thickness of about 3 mils to about 4 mils is preferred, with about 3 mils being more preferred.

The medicine containing element 226 is connected to the current distribution element 224.
Work together. The drug containing element 226 has a main body 252 which is substantially cylindrical with a central hole 254 therethrough. The axis of the central hole 254 coincides with the longitudinal axis of the main body 252. The flange 256 projects perpendicularly to the longitudinal axis of the main body 252 from the lower peripheral edge of the main body 252. Therefore, the medicine containing element 226 has a substantially L-shaped cross section. Various other configurations of the drug containing element are also effective in performing the intended function.

Generally, the medicine containing element 226 is connected to the current distribution element 224 and the lower rim 232.
Further, the drug containing element 226 securely fixes the upper rim 234 to the lower rim 232, thereby
Inside, the current distribution element 224 and the medicine containing element 226 are sealed. A central hole 254 is provided so that a part of the eyeball protrudes in a state where the top surface 258 of the medicine container 226 is in contact with the medicine container.

From the teachings herein, one of ordinary skill in the art can contemplate various other forms of drug containment element 226. For example, in another embodiment, the drug containing element 226 does not have a central hole 254 and is formed of a solid material. In yet another embodiment, the drug containing element 226 is formed from a gel. Further, the drug containing element 226 may have dimensions corresponding to the dimensions of the housing element 222 and the current distribution element 224. For example, the housing element 22
If 2 has a curved shape, the drug containing element 226 is made to have a curved shape or is formed from a material that conforms to the curved surface. Further, the current distribution element 224 may be a single conductive extension 24.
8, the drug containing element 226 may have one corresponding hole cooperating with the conductive extension 248. Given the teachings herein, those skilled in the art will be able to contemplate various other forms of the drug containment element 226 that perform the intended performance.

As mentioned above, the drug containing element 226 can be made from a gel sponge, cross-linked hydrogel, gel, or other similar material. Drug storage element 226
Other materials used to form are known to those skilled in the art. The drug containing element 226 is preferably comprised of a flexible, flexible gel or gel composite matrix, and may be toroidal or curved spherical if required for a particular treatment.

The barrier element 228 is connected to the housing element 222.
And the medicine storage element 226. Barrier element 228
Is in the shape of a substantially circular body 264 having a substantially bell-shaped cross section. The barrier element 228 includes an upper rim 234, and / or
Alternatively, they are mutually locked to the medicine containing element 226 and hold the medicine containing element 226. In one form, the drug containing element 226
The barrier element 228 projects from the top surface 258 by projecting beyond the horizontal plane of the top surface 258. The barrier element 228 contacts the surface of the eye prior to the drug containing element 226 and performs the sealing function described above. In view of the teachings herein, various other forms of barrier element 228 are known to those skilled in the art.

For example, the lower rim 232 is
26 and / or when securely holding the current distribution element 224, the barrier element 228
Barrier element 228 can be configured to conform to 58, ie, beneath the horizontal plane of this top surface. In other forms, barrier element 228 can have various cross-sections known to those skilled in the art, such as forming a seal when barrier element 228 contacts the eye. Further, the location of the barrier element 228 is determined by the particular application for which the iontophoresis device 220 is to be used, as described above. In addition, a second barrier element can be formed in the iontophoresis device 220, which is connected to the inner surface of the central hole 254, for example, to irrigate an eye area such as the cornea. Separate against the introduction of The use of a second barrier element assists in introducing the drug to a particular location where ion penetration is to take place.

According to another aspect of an alternative embodiment of the present invention, the iontophoresis device 220 includes a mounting element 270. In an example configuration as shown in FIG.
70 has a mounting arm 272 extending from the peripheral edge of the lower rim 232 and a mounting portion 276 connected to the distal end 274 of the mounting arm 272. Attachment 276 has a bonding material coupled to attachment 276 to secure to individual cheeks, foreheads, or other parts of the human body. Various other forms of mounting element 270 are also effective in performing the intended function.

For example, the mounting element 270 is connected to the upper rim 23
Do not connect to 4. In an alternative form, the mounting element 270 has a substantially circular shape connected to the mounting arm 272. The circular body has a through hole, which is connected to the outer surface of the lower rim 232 and surrounds the lower rim 232. In another embodiment, the mounting body is connected to the upper rim 2.
34 and the lower rim 232 and the upper rim 23
When the 4 is connected to the lower rim 232, the mounting body is fixed to the housing element 222. In yet another form, the mounting arm 272 may be formed from a brace connected to the patient's head, shoulders, or other part of the body to hold the iontophoretic device 220 during iontophoresis. In another form, the mounting arm 272 is configured to allow the user to manually hold the iontophoresis device 220 in place. In another form, an adhesive or other similar technique is used to secure the mounting portion 276 so that the mounting element 270 can be easily removed without damaging the patient's body. . In view of the teachings herein, one of ordinary skill in the art can contemplate various other forms of mounting element 270.

It is preferred that the mounting element 270 be made of a material that provides sufficient strength and rigidity and that is easily manufactured. Materials of this type include plastics, metals, and composites, such as Teflon, nylon, polyester, polyethylene, and polycarbonate. Mounting element 270
Is preferably composed of polycarbonate.

FIG. 12 and FIG. 13 show an ion permeation device 320 for an eyeball according to another embodiment. Ion infiltration device 220
Most of the points described with respect to
20 applies. The ion osmosis device 320 includes a housing element 322, a current distribution element 324, and a drug containing element 32.
6 and a barrier element 328. Housing element 32
2 has a main body 332 and an upper rim 334. The main body 332 has a form having at least one wing 333. When used as shown in FIG. 12, the body 332 and the wings 333 have a flexible configuration so that the wings 333 can extend below the patient's eyelids. Further, the main body 332 has a form having an orifice 337. The orifice 337 is formed so as to cooperate with the medicine containing element 326, and the cornea of the eyeball can protrude from the orifice.

The upper rim 334 is substantially circular with a rim flange 336 extending from the rim body 335. The flange 336 is connected to the lower surface of the main body 332, and connects the medicine containing element 326 and the current distribution element 324 to the main body 332.
Help to hold on. Various alternative forms of housing element 332 are also effective in performing the intended function.

It is preferred that the housing element 322 be made of a material that provides sufficient strength, yet is flexible enough to be placed beneath the patient's eyelid, and that is easily manufactured.
Materials of this type include plastics, metals, and composites such as Teflon, nylon, polyester, polyethylene, and polycarbonate.

The other components of this embodiment are similar to those described above and are similarly interconnected. For example,
A thin insulating portion 338 is formed on the current distribution element 324. The thinned insulating portion 338 is provided by the ion infiltration device 2
It is much shorter than the insulation 238 at 20 and prevents the ends from penetrating and damaging the eye. Drug storage element 32
6 has basically the same form as the drug containing element 226, but in use, the body 352 of the drug containing element 326 protrudes from the orifice 337, and the flange 356 rests on the lower surface 338 of the body 332. . Therefore,
The drug containing element 326 has a substantially inverted L-shaped cross section. Further, the flange 356 is connected to the current distribution element 3 connected thereto.
24 to cooperate. The barrier 328 is connected to a part of the medicine containing element 326 that penetrates the orifice 337. It is known to those skilled in the art that various other forms of medicament containment element 326 also perform their intended function.

FIGS. 14 to 18 show an ion permeation apparatus 420 for an eyeball according to another embodiment. Most of the points described for other ion permeation devices apply to ion permeation device 420. In general, the iontophoresis device 420 is configured to be easily placed on the temporal bone side of the orbit as shown in FIG. 16 or below the lower eyelid as shown in FIG. 17 and is caused by surrounding tissue It is held in place by frictional forces so that the necessary iontophoretic administration of the drug can be performed. In the embodiment shown here, the ion infiltration device 420
No adhesive is required to hold the in place. This is because the eyelid, or surrounding tissue, maintains frictional contact with the iontophoretic device 420 and prevents the iontophoretic device from moving.

FIGS. 14 and 15 show the configuration of an ion infiltration device 420 used for the temporal bone of the orbit. The housing element 422 of the ion permeation device 420 includes a wire 425
Current distribution element 4 connected to a power supply (not shown) through
Work with 24. The medicine distribution element 426 and the barrier element 428 are connected to the current distribution element 424. The housing element 422 has a body 432 formed in a substantially triangular shape, to which the mounting element 434 is connected on one side. Current distribution element 424, drug containing element 426, and barrier element 4
The body 432 is configured to hold the 28 so that it can be easily manipulated and inserted, and has the property of displacing drugs or current. Accordingly, body portion 432 prevents the drug from passing therethrough and into the surrounding tissue.

In the embodiment shown in FIG.
Is provided with a mounting element 434 to assist in frictional force when the iontophoretic device 420 is releasably positioned. The attachment element 434 is generally hook-shaped, and when the iontophoretic device 420 is inserted into the temporal bone side of the orbit, as shown in FIG. 16, the attachment element 434 cooperates with the cornea of the eyeball. In another form of the invention, an adhesive patch is formed at the end of the mounting element 434 and is used to releasably couple the iontophoretic device 420 in place. In yet another embodiment, FIG.
As shown in FIG. 8, the housing element 422 is formed without the mounting element 434. In view of the teachings herein, those skilled in the art will be able to contemplate various other forms of housing element 422 that may perform the desired function.

For example, the dimensions of ion permeation device 420 can be varied as needed to perform the required ion permeation. As shown in FIGS. 17 and 18, the housing element 422 can be inserted under the lower eyelid and have an elongated shape to cooperate with the lower eyelid.
The housing element 422 and thus the ion infiltration device 420
Can have various cross-sections such as, but not limited to, circular, oval, ie, elliptical, rectangular, square, trapezoidal, and the like.

In general, the housing element 422 can be made of any type of material that is flexible and does not allow passage of current or agents during ion penetration. Examples of the material include, but are not necessarily limited to, flexible plastics, films, composite materials, Teflon, nylon,
There are polyester, polyethylene, polycarbonate, rubber, elastomer, silicone and the like. Housing element 422 is preferably formed of flexible silicone.

In this embodiment, the current distribution element 424 is formed integrally with the housing element 422. The current distribution element 424 can be in the form of a conductive printing ink formed on the inner surface of the housing element 422, as shown by the dotted lines in FIGS. This configuration increases the flexibility of the iontophoresis device 420 because it reduces the number of layers utilized to form the iontophoresis device. In view of the teachings herein, other forms of current distribution element 4
24 is known by those skilled in the art.

In use, as shown in FIG. 16, an ion infiltration device 42 is provided between the orbital side (not shown) and the eyeball.
Slide 0 in. Housing element 422 contacts the surface of the eye socket, and drug containing element 426 and barrier element 428 contact the eye. During positioning of the ion infiltration device 420,
The mounting element 434 cooperates with the corner of the eyeball and the mounting element 43
The end of 4 attaches to the tissue around the eyeball. By doing so, the mounting element 434 prevents movement of the iontophoresis device 420 during operation.

As shown in FIGS. 17 and 18, in another embodiment of the ion infiltration device 420, a housing element 422 is provided.
Are removed from the mounting element 434. In this way, the lower eyelid holds the ion osmosis device 420 in place by the frictional force applied to the housing element 422. In view of the teachings herein, one skilled in the art will be able to contemplate various other forms. For example,
As shown in FIG. 18, two barrier elements 428 are formed in the ion permeation apparatus 420 to form a sealed internal space in which the medicine containing element 426 is installed.

The present invention may be embodied in other specific forms without departing from the scope of the invention. The above embodiments are merely illustrative and do not limit the invention. Accordingly, the scope of the present invention is not limited to the above description but is set forth in the following claims. All modifications that fall within the scope of the invention are within the scope of the invention.

[Brief description of the drawings]

FIG. 1 diagrammatically shows an example ion infiltration system.

FIG. 2 is a side view of an embodiment of the ion permeation apparatus of the present invention.

FIG. 3 is an exploded view of the ion infiltration device along the line 3-3 in FIG. 2;

FIG. 4 is a cross-sectional view of the ion permeation apparatus taken along line 4-4 in FIG. 2;

FIG. 5 is a perspective view of the ion infiltration device of FIG. 2 in use.

FIG. 6 is a perspective view of another embodiment of the ion permeation apparatus of the present invention.

7 is a side view of the device of FIG.

8 is a perspective view of the device of FIG. 6 showing a state of use.

FIG. 9 is an exploded perspective view of an ion permeation apparatus according to another alternative embodiment of the present invention.

FIG. 10 is a side view of the device of FIG. 9;

FIG. 11 is an exploded perspective view of an ion permeation apparatus according to another alternative embodiment of the present invention.

FIG. 12 is an exploded perspective view of a further alternative embodiment of the present invention.

FIG. 13 is a plan view of the device of FIG. 12 applied to the eyeball.

FIG. 14 is still another side view of the ion permeation apparatus of the present invention.

FIG. 15 is a plan view of the device of FIG. 14;

16 is a plan view of the device of FIG. 14 in use.

17 is a plan view of the device of FIG. 14 in use.

18 is a plan view showing an alternative form of the device of FIG.

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 10 Ion osmosis system 12 Power supply 14, 18 Cable 16 Dose controller 20, 120, 220, 320, 420 Ion osmosis device 22, 122, 222, 322, 422 Housing element 24, 124, 224, 324, 424 Current distribution element 26, 126, 226, 326, 426 Drug storage element 28, 128, 228, 328, 428 Barrier element 30 User operation device 32 First end 34 Second end 36, 136 Connector recess 38 Flange 40, 48, 140 hole 46 Circular part 50 Center orifice 54 First receiving end 56 Second receiving end 58 Projecting part 64 Barrier element body 66 First concave part 132 Cup-shaped first part 134 Second end 138 Central part 142 Inner void 148, 248 Conduction extension Portion 152 Cup-shaped member 164 Cup-shaped barrier portion 166 Barrier portion 232 Lower rim 234, 334 Upper rim 235 Circular upper portion 236 Lower circular portion 238, 338 Insulating portion 244, 256, 336, 356 Flange 246 Conductive ring portion 252, 352 Body 254 Center hole 264 Circular body 272 Mounting arm 274 Terminal 276 Mounting part 332, 432 Body part 333 Wing part 335 Rim body 337 Orifice

Claims (47)

[Claims] (A) a housing element; (b) a current distribution element connected to the housing element; (c) a drug containing element connected to the current distribution element; and (d) a tissue of the patient. An ion permeation apparatus, comprising: a barrier element installed in contact with the barrier element, the barrier element being configured to reduce a current flow outside the barrier element. 2. The iontophoresis device of claim 1, wherein the iontophoresis device further comprises a mounting element configured to hold the iontophoresis device in contact with patient tissue. 3. The ion according to claim 1, wherein the housing element further includes a main body, and a connector recess having a form capable of connecting the main body to a user operation device is provided through the main body. Infiltration equipment. 4. The ion permeation apparatus according to claim 1, wherein the housing element has a cup shape. 5. The housing element further comprising an upper rim and a lower rim having a tapered hole therethrough.
The ion infiltration apparatus according to claim 1. 6. The iontophoresis device according to claim 1, wherein said housing element is flexible. 7. The ion osmosis device according to claim 1, wherein the current distribution element is formed by: (a) a conductive portion; and (b) a plurality of conductive extensions flexibly attached to the conductive portion. . 8. The ion permeation apparatus according to claim 1, wherein the current distribution element is formed on a surface of the housing element. 9. The ion permeation apparatus according to claim 1, wherein the current distribution element and the drug containing element are adapted to conform to a surface with which the drug containing element is in contact during ion permeation. 10. The iontophoretic device according to claim 1, wherein the housing element is adapted to conform to a surface with which the drug containing element is in contact during iontophoresis. 11. The ion permeation apparatus according to claim 1, wherein the medicine holding element has a form for holding the medicine and releasing the medicine under the action of an electric potential. 12. The ion permeation apparatus according to claim 1, wherein the barrier element further has a form for preventing foreign substances from penetrating from outside to inside the barrier element. 13. The ion permeation apparatus according to claim 1, wherein the barrier element further has a configuration for preventing a drug from flowing outside the barrier element. 14. A housing element; (b) a flexible current distribution element supported by the housing element; and (c) an adaptation coupled to the current distribution element and the housing element. An ion permeation device comprising: a drug storage element; and (d) a barrier element configured to reduce the flow of an external current. 15. The iontophoresis device of claim 14, wherein the iontophoresis device further comprises a mounting element configured to retain the drug containing element in contact with patient tissue and the barrier element. 16. The housing element comprises a body,
16. The iontophoresis device of claim 15, wherein the body has a connector recess therethrough and the body has a configuration cooperating with a user operating device. 17. The ion permeation apparatus according to claim 16, wherein the current distribution element has a disk shape, and has a plurality of holes at a peripheral edge thereof. 18. The method according to claim 17, wherein the medicine containing element has a substantially cylindrical shape, and the medicine containing element holds a medicine, but has a configuration in which the medicine is released under the action of an electric potential. Ion infiltration equipment. 19. The ion permeation apparatus according to claim 14, wherein the housing element is in a cup shape having a connector recess and an internal space. 20. The current distribution element further comprising: (a) a conductive bend, and (b) a plurality of conductive extensions flexibly attached to the conductive bend.
10. The ion permeation apparatus according to 9. 21. The current distribution element further comprising an insulating portion connected to the conductive curved portion, the insulating portion being connected to the ion osmotic dose controller via the connector recess. The ion infiltration apparatus according to claim 1. 22. The ion permeation device according to claim 20, further comprising an insulating portion connected to the conductive curved portion, wherein the insulating portion is connected to a power source through the connector recess. apparatus. 23. The iontophoretic device of claim 22, wherein the drug containing element has a plurality of concave surfaces fitted in the interior cavity of the housing element and configured to cooperate with a surface of an eyeball. apparatus. 24. The ion permeation apparatus according to claim 23, wherein the barrier element is provided on a peripheral edge of the housing element. 25. The ion permeation apparatus according to claim 14, wherein the housing element has an upper rim and a lower rim. 26. The current distribution element further comprising: (a) a conductive portion fitted into the lower rim; and (b) a plurality of conductive extensions flexibly attached to the conductive portion. The ion permeation device according to claim 25. 27. The iontophoretic device of claim 26, wherein the drug containing element cooperates with the current distribution element and is substantially cylindrical with a hole therethrough. 28. The iontophoretic device of claim 14, wherein said barrier further comprises a form coupled to said drug containing element, said barrier comprising a generally circular portion having a generally bell-shaped cross section. 29. The barrier element cooperates with the current distribution element, the drug containing element, and the housing element to reduce current flow outside the barrier element and to assist in selective administration of a medicament. The ion permeation apparatus according to claim 14, wherein 30. The ion permeation apparatus according to claim 29, wherein the barrier element is configured to prevent foreign substances from penetrating therein. 31. The iontophoretic device of claim 14, wherein the housing element is flexible and configured to conform to a patient's tissue. 32. The ion permeation apparatus according to claim 31, wherein the current distribution element is formed on a first surface of the housing element. 33. The iontophoresis device of claim 32, wherein the current distribution element and the drug storage element are adapted to adapt to tissue of a patient contacted by the drug storage element during ion penetration. 34. The iontophoresis device of claim 33, wherein the tissue surrounding the housing element is configured to hold the iontophoresis device in place by a frictional force applied to the second surface of the housing element. 35. A housing element; (b) a flexible conductive current distribution element cooperating with said housing element; and (c) a drug-filled adaptation coupled to said current distribution element. Ion-permeation into the eyeball, comprising: a drug-containing element having a potential; and (d) a toroidal element having a configuration for reducing the external current and assisting the selective administration of the drug. Ion infiltration equipment. 36. The iontophoresis device of claim 35, wherein the iontophoresis device further comprises a mounting element configured to retain the drug containing element in contact with patient tissue and the toric element. 37. The iontophoresis device of claim 36, wherein the positioning element cooperates with a user operating device to provide flexibility to a user when positioning the iontophoresis device. 38. The iontophoresis device of claim 35, wherein the housing element is formed to cooperate with a surface of an eyeball. 39. The iontophoresis device of claim 38, wherein the current distribution element further comprises a flexure that is flexible and conformable to the surface of the eyeball and that is configured to couple to the housing element. 40. The medicine containing element has a configuration in which the medicine containing element holds a medicine and releases the medicine under the action of an electric potential. 40. The iontophoresis device of claim 39, having a configuration cooperating with at least one of the toric elements. 41. The toroidal element has a substantially oval cross-section and is connected to the housing element, wherein the toroidal element is configured to create a seal when placed on the surface of the eye. 41. The ion permeation apparatus according to claim 40, wherein the toric element has the same. 42. The toric element is configured to prevent foreign substances from penetrating into the toric element.
2. The ion permeation apparatus according to 1. 43. The iontophoresis device of claim 42, wherein said toric element comprises at least two barriers, and wherein at least these two barriers are configured to create a sealed portion therebetween. . 44. (a) (i) a housing element; (ii) a current distribution element supported by the housing element; (iii) a drug containing element coupled to the current distribution element; (B) positioning the iontophoresis device at a desired position in contact with the patient's eye; and (c) providing the iontophoresis device with a barrier element configured to reduce the flow of current. What is claimed is: 1. A method of using an iontophoresis device, which applies an electric current to forcibly inject a drug into a patient's tissue. 45. The step of positioning the iontophoretic device, comprising: (a) placing the barrier element on the surface of an eyeball such that the drug containing element is on the surface of the eyeball; 5. The method of claim 4, further comprising the step of connecting said housing element to a patient such that said barrier element and said drug containing element remain in contact with the surface of said eye.
4. The method according to 4. 46. The method of claim 45, wherein coupling the housing element to a patient comprises attaching a mounting element to one or more tissues of the patient. 47. A step of applying a current to the ion osmosis device, comprising the steps of: (a) installing a second electrode in close contact with the ion osmosis device; and (b) transmitting current to the current distribution element. Providing a power supply; (c) providing an iontophoretic dose controller to control the current transmitted to the iontophoresis device; and (d) the power supply and the iontophoretic dose controller. 47. The method of claim 46, further comprising: actuating a current distribution element along at least one electrical cable to the current distribution element and the drug containing element.