Magnetic resonance imaging compatible convection-enhanced delivery cranial implant devices and related methods

A magnetic resonance imaging (MRI) compatible, convection-enhanced delivery (CED) cranial implant device, comprising:

• at least one cranial implant housing configured for intercranial implantation in at least one cranial opening of a subject, which cranial implant housing comprises a substantially anatomically-compatible shape, at least first and second surfaces, and at least one fluidic circuit comprising at least one cavity and at least one port that fluidly communicates with the cavity through at least the second surface, wherein the cavity comprises, or is capable of comprising, at least one fluidic therapeutic agent;
• at least one CED pump operably connected to the fluidic circuit, which CED pump is configured to convey the fluidic therapeutic agent from the cavity through at least one fluid conduit when the fluid conduit is operably connected to the port to maintain at least one positive pressure gradient of the fluidic therapeutic agent at least proximal to an outlet of the fluid conduit;
• and,
• at least one power source operably connected at least to the CED pump,
• wherein the cranial implant housing, the CED pump, and the power source are fabricated from one or more MRI compatible materials.

A cranial implant device, comprising:

• at least one cranial implant housing configured for intercranial implantation in at least one cranial opening of a subject;
• at least two functional components at least partially disposed within the cranial implant housing, wherein a first functional component comprises a fluid-based physiological condition intervention system that comprises at least one convection-enhanced delivery (CED) pump configured to convey at least one fluidic therapeutic agent from the first functional component to the subject through at least one fluid conduit, and wherein a second functional component comprises a non-fluid-based physiological condition intervention system configured to transmit one or more therapeutic signals from the second functional component to the subject through at least one non-fluid conduit;
• and,
• at least one power source at least partially disposed within the cranial implant housing, which power source is operably connected to the functional components.

A method of treating a neurologically-related disease, condition or disorder of a subject, the method comprising:

• surgically implanting at least one cranial implant device in at least one cranial opening of the subject, wherein the cranial implant device comprises:
• at least one cranial implant housing that comprises a substantially anatomically-compatible shape, at least first and second surfaces, and at least one fluidic circuit comprising at least one cavity and at least one port that fluidly communicates with the cavity through at least the second surface, wherein the cavity comprises at least one fluidic therapeutic agent, and wherein at least fluid conduit extends from the second surface and fluidly communicates with the fluidic circuit;
• at least one convection-enhanced delivery (CED) pump operably connected to the fluidic circuit, which CED pump is configured to convey the fluidic therapeutic agent from the cavity through the fluid conduit to maintain at least one positive pressure gradient of the fluidic therapeutic agent at least proximal to an outlet of the fluid conduit within a cranial cavity of the subject;
• at least one controller operably connected at least to the CED pump, which controller is configured to selectively effect the CED pump to convey the fluidic therapeutic agent through the fluid conduit, and;
• at least one power source operably connected at least to the controller,
• wherein the cranial implant housing, the CED pump, the controller, and the power source are fabricated from one or more magnetic resonance imaging (MRI) compatible materials;
• and,
• conveying an effective amount of the fluidic therapeutic agent from the cavity through the fluid conduit to maintain the positive pressure gradient of the fluidic therapeutic agent at least proximal to the outlet of the fluid conduit within the cranial cavity of the subject, thereby treating the neurologically-related disease, condition or disorder of the subject.

A method of monitoring therapeutic agent administration in a plurality of subjects, the method comprising:

• surgically implanting at least one cranial implant device in each of the plurality subjects, wherein each of the cranial implant devices comprises:
• at least one cranial implant housing that comprises a substantially anatomically-compatible shape, at least first and second surfaces, and at least one fluidic circuit comprising at least one cavity and at least one port that fluidly communicates with the cavity through at least the second surface, wherein the cavity comprises at least one fluidic therapeutic agent, and wherein at least fluid conduit extends from the second surface and fluidly communicates with the fluidic circuit;
• at least one convection-enhanced delivery (CED) pump operably connected to the fluidic circuit, which CED pump is configured to convey the fluidic therapeutic agent from the cavity through the fluid conduit to maintain at least one positive pressure gradient of the fluidic therapeutic agent at least proximal to an outlet of the fluid conduit within a cranial cavity of a given subject;
• at least one controller operably connected at least to the CED pump, which controller is configured to selectively effect the CED pump to convey the fluidic therapeutic agent through the fluid conduit, and for wireless connectivity so as to be remotely monitored, activated, or both, and;
• at least one power source operably connected at least to the controller,
• wherein the cranial implant housing, the CED pump, the controller, and the power source are fabricated from one or more magnetic resonance imaging (MRI) compatible materials;
• and,
• conveying selected amounts of the fluidic therapeutic agent to one or more members of the plurality of subjects using the implanted cranial implant devices;
• and,
• gathering data from one or more selected sets of members of the plurality of subjects using the wireless connectivity of the implanted cranial implant devices, thereby monitoring the therapeutic agent administration in the plurality of subjects.

A surgical method, the method comprising surgically implanting at least one cranial implant device in at least one cranial opening of the subject, wherein the cranial implant device comprises:

• at least one cranial implant housing that comprises a substantially anatomically-compatible shape, at least first and second surfaces, and at least one fluidic circuit comprising at least one cavity and at least one port that fluidly communicates with the cavity through at least the second surface, wherein the cavity comprises at least one fluidic therapeutic agent, and wherein at least fluid conduit extends from the second surface and fluidly communicates with the fluidic circuit;
• at least one CED pump operably connected to the fluidic circuit, which CED pump is configured to convey the fluidic therapeutic agent from the cavity through the fluid conduit to maintain at least one positive pressure gradient of the fluidic therapeutic agent at least proximal to an outlet of the fluid conduit within a cranial cavity of the subject;
• at least one controller operably connected at least to the CED pump, which controller is configured to selectively effect the CED pump to convey the fluidic therapeutic agent through the fluid conduit, and;
• at least one power source operably connected at least to the controller,
• wherein the cranial implant housing, the CED pump, the controller, and the power source are fabricated from one or more magnetic resonance imaging (MRI) compatible materials.

A method of fabricating a cranial implant device, the method comprising:

• forming at least first and second portions of a cranial implant housing, wherein once assembled, the first and second portions form at least one cavity and at least one port that fluidly communicates with the cavity through at least one surface of the cranial implant housing to thereby generate at least one fluidic circuit, and wherein the first and second portions are formed from one or more magnetic resonance imaging (MRI) compatible materials;
• positioning at least one convection-enhanced delivery (CED) pump relative to the first and/or second portions, wherein the CED pump is formed from one or more MRI compatible materials;
• positioning at least one controller relative to the first and/or second portions and operably connecting the controller to the CED pump, wherein the controller is formed from one or more MRI compatible materials;
• positioning at least one power source relative to the first and/or second portions and operably connecting the power source to the controller, wherein the power source is formed from one or more MRI compatible materials;
• attaching the first and second portions of a cranial implant housing to one another to generate the fluidic circuit and such that the CED pump, the controller, and the power source are encased within the first and second portions, and such that the cranial implant housing comprises a substantially anatomically-compatible shape, thereby fabricating the cranial implant device.

An electroactive polymer (EAP) valve-gated pump, comprising:

• a top housing structure comprising at least a top surface, wherein at least one top orifice is disposed through the top surface;
• a bottom housing structure comprising a substantially concave fluid chamber having a top opening, wherein at least first and second fluid channels fluidly communicate with the fluid chamber;
• a membrane portion disposed between the top and bottom housing structures, which membrane portion encloses the concave fluid chamber when the top and bottom housing structures are attached to one another;
• and,
• an EAP-actuation mechanism operably connected to the membrane portion, which EAP-actuation mechanism is configured to displace the membrane portion to thereby effect fluid conveyance.

A convection-enhanced delivery (CED) cranial implant device, comprising:

• at least one cranial implant housing configured for intercranial implantation in at least one cranial opening of a subject, which cranial implant housing comprises a substantially anatomically-compatible shape, at least first and second surfaces, and at least one fluidic circuit comprising at least one cavity and at least one port that fluidly communicates with the cavity through at least the second surface, wherein the cavity comprises, or is capable of comprising, at least one fluidic therapeutic agent;
• at least one CED pump operably connected to the fluidic circuit, which CED pump is configured to convey the fluidic therapeutic agent from the cavity through at least one fluid conduit when the fluid conduit is operably connected to the port to maintain at least one positive pressure gradient of the fluidic therapeutic agent at least proximal to an outlet of the fluid conduit;
• at least one controller operably connected at least to the CED pump, which controller is configured to selectively effect the CED pump to convey the fluidic therapeutic agent through the fluid conduit when the fluid conduit is operably connected to the port and the cavity comprises the fluidic therapeutic agent, and;
• at least one power source operably connected at least to the controller,
• wherein one or more of the cranial implant housing, the CED pump, the controller, the power source, or sub-components thereof, are fabricated from one or more non-MRI compatible materials, which non-MRI compatible materials are selectively and reversibly removable from the CED cranial implant device when the CED cranial implant device is implanted in the subject.

A magnetic resonance imaging (MRI) compatible, convection-enhanced delivery (CED) implant device, comprising:

• at least one implant housing configured for implantation in at least one opening of a subject, which implant housing comprises a substantially anatomically-compatible shape, at least first and second surfaces, and at least one fluidic circuit comprising at least one cavity and at least one port that fluidly communicates with the cavity through at least the second surface, wherein the cavity comprises, or is capable of comprising, at least one fluidic therapeutic agent;
• at least one CED pump operably connected to the fluidic circuit, which CED pump is configured to convey the fluidic therapeutic agent from the cavity through at least one fluid conduit when the fluid conduit is operably connected to the port to maintain at least one positive pressure gradient of the fluidic therapeutic agent at least proximal to an outlet of the fluid conduit;
• at least one controller operably connected at least to the CED pump, which controller is configured to selectively effect the CED pump to convey the fluidic therapeutic agent through the fluid conduit when the fluid conduit is operably connected to the port and the cavity comprises the fluidic therapeutic agent, and;
• at least one power source operably connected at least to the controller,
• wherein the implant housing, the CED pump, the controller, and the power source are fabricated from one or more MRI compatible materials.