Oral mucosal electroporation device and use thereof
Inventors
Kemmerrer, Stephen V. • Broderick, Kate • McCoy, Jay
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12128229-B2
Publication Date
2024-10-29
Expiration Date
Abstract
A device for electroporating cells of a mammalian mucosal membrane includes a housing, an electrode microneedle plate, a voltage return electrode coupled to the housing, and an energy source. The energy source is configured to generate and deliver through the electrode microneedle plate and the voltage return electrode at least one pulse of electrical energy having an electric potential sufficient to electroporate the cells. The electrode microneedle plate is configured to provide an even distribution of a pharmaceutical formulation from the housing and to the mucosal membrane. The electrode microneedle plate includes a plurality of microneedles that are configured to contact the mucosal membrane, deliver the pharmaceutical formulation to a specific depth, and deliver the at least one pulse of ergy to the cells.
Core Innovation
The invention provides a device for electroporating cells of a mucosal membrane of a mammal using an electrode microneedle plate that contacts the mucosal membrane. The device includes a housing configured to be coupled to a syringe capable of storing a pharmaceutical formulation, and a voltage return electrode coupled to the housing. An energy source is in electrical communication with the electrode microneedle plate and the voltage return electrode to generate an electric potential sufficient to electroporate the cells through the electrode microneedle plate and voltage return electrode.
A core aspect is that the electrode microneedle plate is configured to provide an even distribution of the pharmaceutical formulation from the housing and to the mucosal membrane through the electrode microneedle plate. The formulation is deliverable evenly from a rear face of the electrode microneedle plate to a front face of the electrode microneedle plate. A driver actuates an even distribution of the pharmaceutical formulation and includes a piston in physical communication between the housing and the electrode microneedle plate, with the piston remote from the syringe and interposed between the syringe and the electrode microneedle plate when the housing is coupled to the syringe.
The device further specifies that the plurality of microneedles are configured to deliver the pharmaceutical formulation to a specific depth and to deliver at least one pulse of energy at an electrical potential between 1 Volt and 30 Volts, a current between 2 milliamperes and 100 milliamperes, and a duration between 1 millisecond and 250 milliseconds. In the disclosed system, the electrode microneedle plate and remote piston-driven fluid path support co-localized delivering of a pharmaceutical formulation such as a DNA vaccine with subsequent application of electroporation pulses through the microneedles to the mucosal membrane.
Claims Coverage
The provided excerpt identifies two independent claims: clm-00001 (device) and clm-00012 (method). Each independent claim centers on a microneedle-based mucosal electroporation configuration combined with even formulation distribution using a remote piston between the syringe and the electrode microneedle plate, while applying electrical pulses having defined potential, current, and duration ranges.
Device for even distribution and remote piston-driven mucosal electroporation
A device for electroporating cells of a mucosal membrane of a mammal comprising a housing coupled to a syringe holding a pharmaceutical formulation, an electrode microneedle plate with microneedles contacting the mucosal membrane, a driver actuating even distribution of the pharmaceutical formulation through the electrode microneedle plate from a rear face to a front face, and a piston remote from the syringe and interposed between the syringe and the electrode microneedle plate when the housing is coupled to the syringe; a voltage return electrode coupled to the housing; and an energy source generating an electric potential and delivering it to the cells through the electrode microneedle plate and the voltage return electrode, wherein the microneedles deliver pulses having an electric potential between 1 Volt and 30 Volts, a current between 2 milliamperes and 100 milliamperes, and a duration between 1 millisecond and 250 milliseconds.
Method of administering with remote piston-driven even formulation delivery and mucosal electroporation pulses
A method of administering a pharmaceutical formulation to cells of a mucosal membrane of a mammal comprising contacting an electrode microneedle plate having microneedles to the mucosal membrane; contacting a voltage return electrode to tissue adjacent the mucosal membrane; delivering the pharmaceutical formulation from a syringe through a housing and evenly from a rear face of the electrode microneedle plate and through the electrode microneedle plate to a front face and to the mucosal membrane, wherein delivering comprises actuating a piston in physical communication between the housing and the electrode microneedle plate, the piston remote from the syringe and interposed between the syringe and the electrode microneedle plate; generating at least one electrical pulse and communicating it to the electrode microneedle plate; and applying the at least one electrical pulse to the mucosal membrane through the electrode microneedle plate, wherein the at least one electrical pulse has an electric potential between 1 Volt and 30 Volts, a current between 2 milliamperes and 100 milliamperes, and a duration between 1 millisecond and 250 milliseconds.
Across clm-00001 and clm-00012, the claim coverage is directed to microneedle plate contact with a mucosal membrane, even distribution of a pharmaceutical formulation through the electrode microneedle plate from rear to front face using a remote piston in physical communication between the syringe and the electrode microneedle plate, and application of electroporation electrical pulses to the mucosal membrane with the specified electric potential, current, and duration ranges.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
Interested in licensing this patent?