Patent ID: 12193974

DETAILED DESCRIPTION

The Detailed Description refers to accompanying drawings to illustrate exemplary embodiments consistent with the present disclosure. References in the Detailed Description to “one exemplary embodiment,” “an exemplary embodiment,” an “example exemplary embodiment,” etc., indicate that the exemplary embodiment described may include a particular feature, structure, or characteristic, but every exemplary embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same exemplary embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an exemplary embodiment, and it is within the knowledge of those skilled in the art(s) to affect such feature, structure, or characteristic in connection with other exemplary embodiments whether or not explicitly described, such other embodiments, so affected, are intended to be suggested and included in this description.

The exemplary embodiments described herein are provided for illustrative purposes, and are not limiting. Other exemplary embodiments are possible, and modifications may be made to the exemplary embodiments within the spirit and scope of the present disclosure. Therefore, the Detailed Description is not meant to limit the present disclosure. Rather, the scope of the present disclosure is defined only in accordance with the following claims and their equivalents.

The Detailed Description of the exemplary embodiments will so fully reveal the general nature of the present disclosure that others can, by applying knowledge of those skilled in the relevant art(s), readily modify and/or adapt for various applications such exemplary embodiments, without undue experimentation, without departing from the spirit and scope of the present disclosure. Therefore, such adaptations and modifications are intended to be within the meaning and plurality of equivalents of the exemplary embodiments based upon the teaching and guidance presented herein. It is to be understood that the phraseology or terminology herein is for the purpose of description and not of limitation, such that the terminology or phraseology of the present specification is to be interpreted by those skilled in relevant art(s) in light of the teachings herein.

With reference toFIGS.1to10, an aspect of the invention is directed to devices10,10afor electrolytically disrupting debris12, that includes, but is not limited to, includes at least one of a biofilm, bacteria, scurf, keratinization, dead cells, and secreted fluids, along the upper eyelid margin14, the lower eyelid margin16, or both the upper and lower eyelid margins14,16of an eye18of a subject. With reference toFIGS.1,5,8, and12embodiments of the invention include electrodes20,20a,20b,20c,22,22a,22b,22c,24,24a,26,26aon an eyelid contacting portion30to contact the one or both of the upper eyelid32and the lower eyelid34of a subject to apply low voltage and low current electrical energy to the eyelids32,34. The electrical energy passes, illustrated as arrows with dashed lines, from one or more anode electrodes through the eyelid(s) and debris on the eyelid margin to one or more cathode electrodes. The electrical energy passing through the debris12disrupts the debris12and allows for disrupted debris to be easily removed, such as with a wash solution (FIGS.8and12) or by wiping with a tissue or towel. In some embodiments, the device includes nozzles (FIGS.8to13) for applying the wash solution to the eyelid margin to remove the disrupted debris.

In an embodiment of the invention, the voltage of the electrical energy applied to disrupt the debris12is in the range from about 0.1 V to about 20 V. In another embodiment, the voltage applied to disrupt the debris12is in the range from about 0.1 V to about 10 V. In another embodiment, the voltage applied to disrupt the debris12is in the range from about 0.1 V to about 5 V. In another embodiment, the voltage applied to disrupt the debris12is in the range from about 0.1 V to about 3 V. In another embodiment, the voltage applied to disrupt the debris12is in the range from about 0.1 V to about 2 V. In another embodiment, the voltage applied to disrupt the debris12is in the range from about 0.1 V to about 1 V. In another embodiment, the voltage applied to disrupt the debris12is in the range from about 0.5 V to about 10 V. In another embodiment, the voltage applied to disrupt the debris12is in the range from about 1 V to about 10 V. In another embodiment, the voltage applied to disrupt the debris12is in the range from about 2 V to about 10 V. In another embodiment, the voltage applied to disrupt the debris12is in the range from about 3 V to about 10 V. In another embodiment, the voltage applied to disrupt the debris12is in the range from about 5 V to about 10 V. In another embodiment, the voltage applied to disrupt the debris12is in the range from about 10 V to about 20 V.

In an embodiment of the invention, the current applied to disrupt the debris12is less than about 3 milliamps. In another embodiment of the invention, the current applied to disrupt the debris12is in a range from about 0.1 milliamps to about 3 milliamps. In another embodiment of the invention, the current applied to disrupt the debris12is in a range from about 0.5 milliamps to about 3 milliamps. In another embodiment of the invention, the current applied to disrupt the debris12is in a range from about 1 microamp to about 3 milliamps.

With reference toFIGS.2,3,8,11, and14embodiments of the device10,10a,10binclude a power supply40to supply electrical energy to the electrodes20,22,24,26. Embodiments of the device10,10a,10bmay also include hardware, software, or any combination thereof that may be used to control the electrical energy being supplied to the electrodes. The hardware, such as a controller42, may include software and be electrically coupled to the power supply40and the electrodes20,22,24,26. Embodiments of the device10,10a,10bmay also include instructions supplied by a machine-readable medium, which may be read and executed by one or more processors. A machine-readable medium may include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computing device). For example, a machine-readable medium may include read only memory (ROM); random access memory (RAM); magnetic disk storage media; optical storage media; flash memory devices; electrical optical, acoustical or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.), and others. Further software routines and instructions may be described herein as performing certain actions. However, it should be appreciated that such descriptions are merely for convenience and that such actions in fact result from computing devices, processors, controllers42, or other devices executing the software, routines, instructions, etc.

In an embodiment, the device10,10a,10bmay include a user interface43that includes an input system and a display system. The input system allows the user to adjust the operation of the device10,10a,10band, in some embodiments, interact with the controller42to control the device10,10a. For example, the user interface43may allow the user to activate the supply of electrical energy to the electrodes20,22,24,26, to increase or decrease the electrical energy being supplied to the electrodes20,22,24,26, increase or decrease the duration of treatment, activate a pump controlling the flow of wash solution from a reservoir44to nozzles36(FIG.11), activate a pump controlling the flow of waste fluid from irrigation ports37to a waste fluid receptacle such as a waste fluid reservoir75or sink (FIG.8), and combinations thereof. The input system may include at least one of a button46, a dial, a trigger48, a switch, a touch screen and other input devices as are known in the electrical arts. The display system conveys information to the user with respect to the status of the device. In an embodiment, the display may include one or more lights52such as light emitting diodes, an LCD display47(FIG.13), gauges, or other types of displays as are known in the art. For example, the device10,10bmay include one or more lights52to indicate the powered on status of the device10,10b, indicate the level of energy remaining in the power supply, such as in a battery, or if the electrodes are making sufficient contact with the skin of the subject undergoing treatment.

As illustrated inFIG.3, the controller42, power supply40, user interface (e.g., lights52, buttons,46, and triggers48) may be contained in a housing55,55ashaped in the form of a handle from which the eyelid contacting portion30,30a,30b,30cprojects. It will be appreciated that the controller, power supply, user interface, and other components may be in one or more housings and the one or more housings need not be in the form of a handle. For example, in the embodiment illustrated inFIG.13, the housing with one or more components may be a base unit57that can be located some distance away from the subject but that is also electrically coupled to the eyelid contacting portion by a flexible member, such as an electric cable. The base unit57may optionally be fluidly coupled to the eyelid contacting portion by one or more flexible tubes to allow for the delivery of wash fluid, the removal of waste fluid, and combinations thereof for eyelid contacting portion having such functionality.

With reference toFIGS.1to4, an embodiment of the device10for treating an ocular disorder, particularly with respect to eyelid margin diseases, includes an eye contacting portion30with a surface54that includes a first electrode20and a second electrode22. The surface54of the eye contacting portion30may be curved to generally correspond to the external curvature of the eye and in particular, the curvature of the upper and lower eyelids18,19so that the first electrode20may make contact across the outer surface of the upper eyelid18and the second electrode22may make contact with the outer surface of lower eyelid19when the eyelids18,19are in a closed position. Each of the first and second electrodes20,22has a width W that generally corresponds to the width of the each of the upper and lower eyelids18,19. In an embodiment, each of the first and second electrodes22,22has a width W that ranges from 2 cm to about 5 cm. One of the first electrode or second electrodes20,22functions as a cathode and the other of the first electrode or second electrodes20,22functions as an anode. The first and second electrodes20,22are electrically coupled to a circuit50that includes a power supply40(FIG.3).

With reference toFIG.1, during use, electrical energy (arrows with broken lines) flows from the first electrode20through the upper eyelid18and the upper eyelid margin14to the debris12. The electrical energy then passes through and disrupts the debris12before passing through the lower eyelid margin16and lower eyelid19to the second electrode22. One of ordinary skill in the art will appreciate that the electrical energy could flow in the opposite direction from the second electrode22to the first electrode20if the second electrode22is the anode and the first electrode is the cathode.

In an embodiment, an electrolyte solution may be added to the eye, such as between the upper and lower eyelid margins14,16, to improve the disruption of debris12by the electrical energy.

FIGS.5,6, and7illustrate an alternative embodiment of the eye contacting portion30aof the device10. In the alternative embodiment, the surface54aof the eye contacting portion30ais separated into an upper portion56and a lower portion58by a shelf60. The shelf60has an upper shelf surface62and a lower shelf surface64. The upper portion56includes a first electrode20aand the upper shelf surface62adjacent the upper portion56includes a second electrode22a. One of the first or second electrodes20a,22awill be an anode and the other of the first or second electrodes20a,22awill be a cathode. Similarly, the lower portion58includes a third electrode24and the lower shelf surface64includes a fourth electrode26. One of the third or fourth electrodes24,26will be an anode and the other of the third or fourth electrodes24,26will be a cathode. The first, second, third, and fourth electrodes20a,22a,24,26are electrically coupled to a circuit that includes a power supply.

During use, the second electrode22aon the upper shelf surface62contacts the upper eyelid margin14of the upper eyelid18and may be curved to generally correspond with the curvature of the upper eyelid margin14. The second electrode22awill also contact debris12along the upper eyelid margin14of the upper eyelid18. Similarly, the fourth electrode26on the lower shelf surface64contacts the lower eyelid margin16of the lower eyelid19and may be curved to generally correspond with the curvature of the lower eyelid margin16. As with the previous embodiment, the first and third electrodes20a24each have a width that corresponds generally with the widths of the respective upper and lower eyelids18,19. Similarly, the second and fourth electrodes22a,26on the upper and lower shelf surfaces62,64each have a length and a width that generally corresponds with the length and width of the respective upper and lower eyelid margins14,16for the upper and lower eyelids18. In an embodiment, the widths of each of the first, second, third, and fourth electrodes20a,22a,24,26may range between about 2 cm and about 5 cm. In an embodiment, the lengths of the second and fourth electrodes may range between about 0.5 mm and 3 mm, or between about 1 mm and about 2 mm.

In the embodiment illustrated inFIG.5, the second and fourth electrodes22,26on the upper and lower shelf surfaces62,64, respectively, are anodes and the first and third electrodes20a,24on the upper and lower portions56,58of surface54aare cathodes, when the device utilizes a direct current power source. Electrical current flows from the anodes through debris12on or near the upper and lower eyelid margins14,16to disrupt the debris12. The electrical current then travels through the upper and lower eyelids18,19to the cathode to complete the circuit. The power supply, which may be a battery or other source of electricity, provides electrical energy to the anodes. It will be appreciated that the polarity of the electrodes may be reversed. It will also be appreciated that an alternating current power source, which will obviate the anode cathode designation of the electrodes.

FIGS.8,9, and10illustrate an alternative embodiment of the eye contacting portion30bof the device10. In the alternative embodiment, the eye contacting portion30bis separated into an upper channel68and a lower channel70.

The upper channel68is defined by an upper outer sidewall72and an opposite upper inner sidewall74. The upper outer sidewall72is joined to the upper inner sidewall74by an upper base wall76. The upper base wall76includes a first electrode20b. One of the upper outer and upper inner sidewalls72,74includes a second electrode22b. In an embodiment, both of the upper outer and upper inner sidewalls72,74include an electrode, with one of the upper sidewalls including the second electrode22band the other upper sidewall including a third electrode24a. One of the first and second electrodes20b,22bwill be an anode and the other of the first or second electrodes20b,22bwill be a cathode. In embodiments with a third electrode24a, the third electrode24awill have the same polarity as the second electrode22b. In other words, if the second electrode22bis a cathode, the third electrode24awill also be a cathode.

The lower channel70is defined by a lower outer sidewall80and an opposite lower inner sidewall82. The lower outer sidewall80is joined to the lower inner sidewall82by a lower base wall84. The lower base wall84includes a first electrode20c. One of the lower outer and lower inner sidewalls80,82includes a second electrode22c. In an embodiment, both of the lower outer and lower inner sidewalls80,82include an electrode, with one of the lower sidewalls including the second electrode22cand the other lower sidewall including a third electrode24b. One of the first and second electrodes20c,22cwill be an anode and the other of the first or second electrodes20c,22cwill be a cathode. In embodiments with a third electrode24b, the third electrode24bwill have the same polarity as the second electrode22c. In other words, if the second electrode22cis a cathode, the third electrode24bwill also be a cathode.

During use, the upper eyelid18of a subject is inserted into the upper channel68and the lower eyelid19of the subject is inserted into the lower channel70. The inner surfaces88,90of the respective upper and lower eyelids18,19will contact electrodes located on the respective upper and lower inner sidewalls74,82. The outer surfaces92,94of the respective upper and lower eyelids18,19of the subject will contact electrodes that may be located on the respective upper and lower outer sidewalls92,94. The upper and lower eyelid margins14,16of the respective upper and lower eyelids18,19, as well as debris12on the eyelid margins14,16will contact the electrodes on the upper and lower base walls76,84. Electrical current will flow from the anodes through the debris and eyelid to the cathodes.

Alternative embodiments, such as illustrated inFIGS.8-13, may include one or more nozzles36in the upper and lower channels68,70to spray a wash solution96, such as a balanced salt solution, across the upper and lower eyelid margins14,16to assist with removing disrupted debris along the upper and lower eyelid margins14,16. In an embodiment, the nozzles36are positioned in the upper and lower inner sidewalls74,74a,82,82ato spray wash solution96away from the eyeball98to wash disrupted debris away. The nozzles36will be in fluid communication with a wash solution reservoir44(FIGS.8and11). The wash solution96may be pushed through the nozzles36with a pump100. The pump100may be operated by the controller42. In the alternative, the wash solution may be gravity fed to the nozzles36(FIG.13).

Alternative embodiments, such as illustrated inFIGS.8-10, may also include one or more irrigation ports37in the upper and lower channels in the upper and lower channels68,70to remove wash solution96and debris from the channels and to decreases the overflow of wash fluid and debris into the eye and onto the face of the subject. The irrigation ports37may be in fluid communication with a waste fluid receptacle such as a waste fluid reservoir45or sink (FIG.8). The drained wash solution96may be drawn into the irrigation ports37by a pump, such as vacuum pump101. The pump, such as vacuum pump101, may be operated by the controller42.

FIGS.11and12illustrate an alternative embodiment of the device that includes upper and lower channels68a,70asimilar to the upper and lower channels68,70in the embodiment illustrated inFIGS.8,9, and10. As best illustrated inFIG.12, the upper and lower outer sidewalls72a,80ain this alternative embodiment may move relative to the upper and lower base walls76a,84aand upper and lower inner sidewalls74a,82a. This movement allows the upper and lower channels68a,70ato open to ease insertion of the upper and lower eyelids18,19into the respective upper and lower channels68a,70a. After the upper and lower eyelids18,19are inserted into the respective upper and lower channels68a,70a, the upper and lower outer sidewalls72a,80amay be move toward the upper and lower inner sidewalls74a,82a, such as the through a trigger48coupled to a mechanism for moving the upper and lower outer sidewalls72a,80auntil the sufficient contact is made with the electrodes in the upper and lower channels68a,70a. The electrodes and nozzles36may be activated to remove debris12as discussed above with respect to the embodiment disclosed inFIGS.8,9, and10.

While the embodiments illustrated inFIGS.8-12are shown as having upper and lower channels68,68a,70,70a, it will be appreciated that embodiments of the device10and10amay be made with a single channel to allow for treatment of one eyelid at a time.

FIG.13illustrates an alternative embodiment of the eyelid contacting portion30dof the device10b. In this embodiment, upper and lower inner side walls74band82bare separated by shelf having upper and lower base walls76band84b. The eyelid connecting portion30dis configured to be positioned such that the upper and lower inner side walls74band82bare placed between the inner surface of the eyelid and the outer surface of the eyeball. An electrode20b, such as an anode, is positioned on the upper base wall76band another electrode20c, such as another anode, is position on the lower base wall84b. In an embodiment, the electrodes20b,20con the upper and lower base walls76b,84bare generally of the same polarity, i.e., either both anodes or both cathodes. During use, the eyelid contacting portion30dis positioned such that the margin of the eyelid of the upper eyelid, as well as debris thereon, contacts the electrode20bon the upper base wall76band the margin of the eyelid of the lower eyelid, as well as debris thereon, contacts the electrode20con the lower base wall.

The electrodes20b,20con the eyelid contacting portion30dare electrically coupled to a base unit57by a flexible member, such as an electric cable. In the exemplary embodiment, the flexible member projects from the shelf such that, during use, the flexible member projects between the upper and lower eyelids of the subject.

This embodiment also utilizes another electrode22dthat is separate from the eyelid contacting portion30d. Generally speaking, this electrode will have an opposite polarity from the polarity of the electrodes20b,20con the eyelid contacting portion30d. In an embodiment, the electrodes20b,20con the eyelid contacting portion30dare anodes and the electrode22dis a cathode. In another embodiment, the electrodes20b,20con the eyelid contacting portion30dare cathodes and the electrode22dis an anode. The electrode22dmay include an electrolyte, such as an electrolytic gel, an adhesive, or an electrolytic adhesive to improve contact with the skin. Electrodes as are known in the art may be utilized for this purpose. The electrode22dis electrically coupled to the base57with an electric cable. During use, the electrode22dis position adjacent the eye being treated with the eyelid contacting portion30d. In an embodiment, the electrode22dis position between 1 inch and 2 inches from margin of the lower eyelid. In an embodiment, the electrode is position below the eye being treated. In another embodiment, the electrode22dis position lateral to the eye being treated. In another embodiment, the electrode22dis position above the eye being treated.

In an embodiment, the eyelid contacting portion includes one or more wash fluid nozzles36. In an embodiment, the wash nozzles are located along the upper and lower inner side walls74band82bon the surface that faces the inner surface of the eyelid such that washing fluid expelled from the nozzles36will wash away debris disrupted by the electrodes20b,20c. The wash fluid nozzles36are fluidly coupled to a reservoir of washing fluid by a flexible tube. In an embodiment, the flexible tube connects to a luer lock that projects from the shelf of the eyelid connecting portion. In an embodiment, the wash fluid reservoir is positioned at a height that is greater than the treatment height of the patient so that washing fluid is gravity fed to the fluid from the nozzles36. It will be appreciated that a pump could be used to pump the washing fluid from a reservoir to the nozzles.

It will be appreciated that the electrodes may be made from materials as are known in the art for transmitting electrical energy to the surfaces of the skin. For example, the electrodes can be made of a number of materials, such as metals, carbon graphite electrodes, and electrically conducting rubber sheets. Exemplary metals include gold, silver, and other biologically tolerated metals and alloys thereof.

In embodiments of the invention, the eyelid contacting portions30,30a,30b,30c,30dmay be removable from the housing such that the eyelid contacting portions may be disposed of after a single use or, if reused, sterilized between uses. As such, an embodiment of the invention is directed to removable eyelid contacting portions that are configured to be reversibly coupled to a housing. Such removable eyelid contacting portions may have an electrical coupling, such a male or female electrical contact that mates with a corresponding electrical contact on the housing. The removable eyelid contacting portions may also have a contacting surface having a shape that mates with a correspondingly shaped contacting surface on the housing.

Embodiments of the invention utilize only electrical energy to disrupt debris without utilizing other forms of energy to result in debris disruption. As described above, alternative embodiments may utilize electrical energy to disrupt debris in combination with a wash fluid to assist with debris disruption, to remove debris, or both to disrupt and remove debris.

Another embodiment of the invention may include an ultrasonic driver102coupled to the eyelid contacting portion to induce ultrasonic movement of an eyelid contacting portion (FIGS.2and11). Embodiments of the invention will utilize the ultrasonic driver102in combination with electrical energy applied through electrodes to disrupt debris. Accordingly, these devices will include electrodes, as described above as well as an ultrasonic driver. Other embodiments of the invention will utilize only the ultrasonic driver102to induce ultrasonic movement of the eyelid contacting portion to disrupt debris without applying electrical energy to the eye through electrodes to disrupt debris. Accordingly, these embodiments of the device will have an ultrasonic driver but will lack electrodes.

The embodiments utilizing an ultrasonic driver102may optionally utilize a wash fluid delivered through nozzles36to assist with disrupting, removing, or both disrupting and removing debris. Accordingly, embodiments of the device utilizing a wash fluid will include nozzles, a reservoir, and pump, as previously described. These embodiments may also optionally utilize irrigation ports37to remove fluids, such as waste fluid and debris, during use. Accordingly, embodiments of the device may include irrigation ports37coupled to a pump, such as a vacuum pump. The waste fluid may optionally be pumped to a reservoir or to a waste receptacle, such as a sink.

With reference toFIGS.2and11, the ultrasonic driver102may be contained in a housing55,55afrom which an eyelid contacting portion30,30a,30a,30b,30cprojects. The ultrasonic driver102is physically coupled, such as through a shaft, to the eyelid contacting portion such that ultrasonic energy from the ultrasonic driver102is transferred to the eyelid contacting portion. An exemplary ultrasonic driver is a piezoelectric driver. The piezoelectric driver may cause the eyelid contacting portion to oscillate as a frequency that ranges between about 10 kHz to about 100 kHz. In the embodiments illustrated inFIGS.2and11, the ultrasonic driver102is provided in addition to the electrodes. However, it will be appreciated that the device may include ultrasonic driver without electrodes for delivering electrical energy to the eyelid.

During use, the eyelid contacting portion is brought into contact with the external portion of the upper eyelid, the external portion of the lower eyelid, the upper eyelid margin between the external surface of the upper eyelid and the internal surface of the upper eyelid, the lower eyelid margin between the external surface of the lower eyelid and the internal surface of the lower eyelid, the internal surface of the upper eyelid, the internal surface of the lower eyelid or combinations thereof. It is further appreciated that the eyelid contacting portion simultaneously contacts the relevant portion of the eyelid as described in the previous sentence across at least fifty percent of the width of the eyelid. In another embodiment, the eyelid contacting portion contacting portion contacts the relevant portion of the eyelid across at least seventy five percent of the width of the eyelid. In another embodiment, the eyelid contacting portion contacting portion contacts the relevant portion of the eyelid across at least ninety percent of the width of the eyelid. The width of the eyelid being defined as the portion of either the upper or lower eyelid that extends between the medial commissure and the lateral commissure. The ultrasonic driver102is activated and ultrasonic energy is applied to the at least one of the eyelid surfaces as well as to debris located thereon by the eyelid contacting portion.

In an embodiment, ultrasonic energy is applied without the application of any other form of energy to disrupt debris. In another embodiment, the ultrasonic energy is applied in combination with another form of energy to disrupt debris. For example, ultrasonic energy may be applied in combination with electrical energy to disrupt debris. In an embodiment, the ultrasonic energy may be applied at the same time as the other form of energy, such as electrical energy. In another embodiment, the ultrasonic energy and the other form of energy, such as electrical energy, are not applied at the same time. For example, ultrasonic energy and the other form of energy, such as electrical energy, may be applied in an alternating manner, or one of these forms of energy may be applied first and the other form of energy may be applied second. This alternating pattern may be repeated. In an embodiment, the other form of energy, such as electrical energy, is applied first and the ultrasonic energy is applied second. In another embodiment, the ultrasonic energy is applied first and the other form of energy, such as electrical energy, is applied second. The ultrasonic energy is applied for a duration and at a frequency sufficient to disrupt debris on the eyelid, and in particular debris on the eyelid margin.

FIG.14depicts a graph200that shows an exemplary monophasic waveform202which may be used to provide electrical energy to the eye contacting portion30of device10. The monophasic waveform202may include a plurality of pulses (e.g., an initial pulse204and subsequent pulse206) that repeat over a cycle time208and which can be used to electrolytically disrupt debris on an eyelid margin. Each pulse204,206may have a pulse duration210and an interpulse duration212that collectively define the cycle time208of monophasic waveform202. Each pulse204,206may have a relatively short rise time214,216during which the amplitude of the monophasic waveform202rises from an initial baseline amplitude a0, (e.g., zero volts or amps) to a peak218,220having a peak amplitude a1, and fall time222,224during which the amplitude of the monophasic waveform202falls back toward the baseline amplitude a0, e.g., by decaying at a generally exponential rate.

Prior to time t0, the monophasic waveform202may be at the initial baseline amplitude a0. At the beginning of the cycle time208, the amplitude of the monophasic waveform may begin rising and reach the initial peak218in a relatively short period of time, e.g., 1 μs. After reaching the initial peak218, the amplitude of the monophasic waveform202may drop back toward the baseline amplitude a0over a period of time. The drop in the amplitude may be exponential in nature as the electrical energy dissipates into the patient. The period between peaks218,220may be selected to allow the amplitude of the monophasic waveform to essentially return to the baseline amplitude a0before generating subsequent peak220. At time ti, the amplitude of the monophasic waveform202may begin to rise to subsequent peak220, which may have the same amplitude a1as the initial peak218. The amplitude of the monophasic waveform may then drop back toward the baseline amplitude a0over a period of time in similar manner as described for the initial peak218. After the final pulse of the plurality of pulses, the monophasic waveform202may remain at baseline amplitude a0for the remainder of cycle time208.

The amplitude of the monophasic waveform202may be characterized using current or voltage so that the baseline amplitude a0is zero volts or amps. For peaks218,220characterized by voltage, the peak amplitude a1may be approximately 350V. For peaks218,220characterized by current, the peak amplitude a1may be approximately 700 mA. An exemplary monophasic waveform202may have a cycle time208of approximately 10 ms and a pulse duration210of approximately 0.2 ms.

FIG.15depicts a graph230that shows an exemplary biphasic waveform232that may be used to provide electrical energy to the eye contacting portion30of device10. The biphasic waveform232may be assymetric, and may include a pulse234that repeats over a cycle time236and which can be used to electrolytically disrupt debris on an eyelid margin. Each pulse234may include a positive phase238, a negative phase240, and a pulse duration242. The pulse duration242and an interpulse duration244may collectively define the cycle time236of biphasic waveform232.

The positive phase238of pulse234may have a relatively short rise time246(e.g., 1 μS) during which the amplitude of the biphasic waveform232rises from the initial baseline amplitude a0to a positive peak amplitude a3, and relatively short fall time248during which the amplitude of the biphasic waveform232falls toward a negative peak amplitude a4. In an embodiment of the invention, the positive peak amplitude a3may have about the same magnitude as the negative peak amplitude a4. The positive phase238may comprise a portion (e.g., about a third) of the pulse234during which the amplitude of biphasic waveform232is held at the positive peak amplitude a3. During the negative phase240of pulse234, the amplitude of the biphasic waveform232may decay or be driven toward the baseline amplitude a0at a generally linear rate from the negative peak amplitude a4back toward the baseline amplitude a0over the remaining portion of the pulse duration242.

The amplitude of the biphasic waveform232may also be characterized using current or voltage. In cases where the biphasic waveform232is characterized by voltage, the peak amplitude a3may be in a range of approximately 0 to +50V, and the peak amplitude a4may be in a range of approximately 0 to −50V. In cases where the biphasic waveform232is characterized by current, the peak amplitude a3may be in a range of approximately 0 to +100 mA, and the peak amplitude a4may be in a range of approximately 0 to −100 mA. An exemplary biphasic waveform232may have a pulse duration242in a range of approximately 50 to 300 μs, and may be user adjustable in increments, e.g., 10 μs increments. The exemplary biphasic waveform may further include a cycle time236in a range of approximately 6.67 to 500 ms, yielding a frequency of 2-150 Hz, and may be adjustable in increments of frequency, e.g., 1 Hz increments.

FIG.16depicts a graph250that shows an exemplary triphasic waveform252that may be used to provide electrical energy to the eye contacting portion30of device10. The triphasic waveform252may include a pulse254that repeats over a cycle time256and which can be used to electrolytically disrupt debris on an eyelid margin. Each pulse254may include two positive phases258,260, a negative phase262, and a pulse duration264. The pulse duration264and an interpulse duration266may collectively define the cycle time256of triphasic waveform252.

The initial positive phase258may have a peak268that predominates over peak270of subsequent positive phase260and over peak272of negative phase262. That is, the amplitude a5of peak268may be greater than the amplitudes a6, a7of the subsequent peaks270,272. Each of the phases258,260,262may have a generally sinusoidal shape with peak amplitudes a5, a6, a7that follow a generally exponential decay rate as compared to the preceding peaks268,270,272.

Prior to time t0, the triphasic waveform252may initially be at the baseline amplitude a0. At the beginning of the cycle time256, the amplitude of the triphasic waveform252may rise to positive peak268following a generally sinusoidal curve. The amplitude of the triphasic waveform252may then drop below the baseline amplitude a0over a period of time following a generally sinusoidal curve to reach negative peak272between zero-crossing times t3and t4. The amplitude of the triphasic waveform252may then begin to rise above the baseline amplitude a0over a period of time following a generally sinusoidal curve to reach positive peak270between zero-crossing times time t4and t5. Each peak270,272may have a reduced magnitude in comparison to the magnitude of the immediately preceding peak268,270. After reaching peak270, the amplitude of the triphasic waveform252may drop toward the baseline amplitude a0over a period of time and remain there for the remainder of cycle time256.

FIG.17depicts an exemplary controller42in accordance with an embodiment of the invention. The controller42may include a processor300, a memory302, an input/output (I/O) interface304, and a user interface306. The processor300may include one or more devices selected from microprocessors, micro-controllers, digital signal processors, microcomputers, central processing units, field programmable gate arrays, programmable logic devices, state machines, logic circuits, analog circuits, digital circuits, or any other devices that manipulate signals (analog or digital) based on operational instructions that are stored in the memory302. Memory302may be a single memory device or a plurality of memory devices including but not limited to read-only memory (ROM), random access memory (RAM), volatile memory, non-volatile memory, static random access memory (SRAM), dynamic random access memory (DRAM), flash memory, cache memory, or any other device capable of storing digital information. Memory302may also include a mass storage device (not shown) such as a hard drive, optical drive, tape drive, non-volatile solid state device or any other device capable of storing digital information.

Processor300may operate under the control of an operating system308that resides in memory302. The operating system308may manage controller resources so that computer program code embodied as one or more computer software applications, such as a controller application310residing in memory302may have instructions executed by the processor300. In an alternative embodiment, the processor300may execute the controller application310directly, in which case the operating system308may be omitted. One or more data structures312may also reside in memory302, and may be used by the processor300, operating system308, and/or controller application310to store data.

The I/O interface304may operatively couple the processor300to other components of embodiments of the invention, such as electrodes20,20a,20b,20c,22,22a,22b,22c,24,24a,26,26a, pump100, and/or vacuum pump101. The I/O interface304may include signal processing circuits that condition incoming and outgoing signals so that the signals are compatible with both the processor300and the components to which the processor300is coupled. To this end, the I/O interface304may include analog-to-digital (A/D) and/or digital-to-analog (D/A) converters, voltage level and/or frequency shifting circuits, optical isolation and/or driver circuits, and/or any other analog or digital circuitry suitable for coupling the processor300to the other components of embodiments of the invention.

The user interface306may be operatively coupled to the processor300of controller42in a known manner to allow a system operator to interact with the controller42. The user interface306may include a display such as a video monitor, alphanumeric displays, a touch screen, a speaker, and any other suitable audio and visual indicators capable of providing information to the system operator. User interface306may also include input devices and controls such as an alphanumeric keyboard, a pointing device, keypads, pushbuttons, control knobs, microphones, etc., capable of accepting commands or input from the operator and transmitting the entered input to the processor300. In this way, user interface306may enable manual initiation or selection of system functions, for example, during system set-up, calibration, and chemical loading.

While the present invention has been illustrated by the description of one or more embodiments thereof, and while the embodiments have been described in considerable detail, they are not intended to restrict or in any way limit the scope of the appended claims to such detail. For example, one of ordinary skill will appreciate that each of the electrodes could be replaced with a plurality of smaller electrodes space apart so as to apply electrical energy sufficient to disrupt debris on the eyelid margin. Further, exemplary embodiments of the invention have been illustrated or described as utilizing direct current. Alternative embodiments of the inventions described herein may utilize alternating current. Additional advantages and modifications will readily appear to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and method and illustrative examples shown and described. Accordingly, departures may be from such details without departing from the scope or spirit of the general inventive concept.