Implantable medical device for minimally-invasive insertion

• US 9,700,668 B2
• Filed: 02/27/2014
• Issued: 07/11/2017
• Est. Priority Date: 02/28/2013
• Status: Active Grant

• Current Assignee: DARE MB Incorporated
• Original Assignee: Microchips Biotech, Inc. (Keratin Biosciences, Inc.)
• Inventors: Farra, Robert
• Primary Examiner(s): Hayman, Imani
• Assistant Examiner(s): Ponton, James D
• Application Number:
  US14/192,605
• Publication Number:
  US 20140243624A1
• Time in Patent Office: 1,230 Days
• CPC Class Codes: A61K 9/0097 Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips intradermal microneedle arrays A61K9/0021; MEMS in general B81B7/02
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 2205/3515 using magnetic means
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: Y10T 29/49128 Assembling formed circuit to base

Abstract

In one aspect, containment devices are provided that include a microchip element having one or more containment reservoirs that are configured to be electrically activated to open; an electronic printed circuit board (PCB) or a silicon substrate positioned adjacent to the microchip element; one or more electronic components associated with the microchip element or the PCB/silicon substrate; and a first inductive coupling device associated with the microchip element or the PCB/silicon substrate, wherein the first inductive coupling device is in operable communication with the one or more electronic components. In another aspect, implantable drug delivery devices are provided that include a body housing at least one drug payload for actively controlled release, wherein the ratio of the volume of the at least one drug payload to the total volume of the implantable drug delivery device is from about 75 μL/cc to about 150 μL/cc.

Claims

1. A containment device, comprising:

a microchip element comprising one or more containment reservoirs that are configured to be electrically activated to open;

an electronic printed circuit board (PCB) fixed to the microchip element, wherein the PCB comprises an alumina or other biocompatible ceramic substrate;

one or more electronic components associated with the microchip element or the PCB; and

a first inductive coupling device incorporated into the microchip element or the PCB, wherein the first inductive coupling device is in communication with the one or more electronic components,

wherein the containment device does not have a housing, and

wherein the microchip element comprises;

a silicon substrate having a first side, an opposed second side, and at least one aperture extending therethrough, wherein the first side of the silicon substrate comprises an electrically conductive reservoir cap which closes off the at least one aperture,

a primary substrate which is formed of silicon or other metalloid, a polymer, or a glass or other ceramic material, wherein the primary substrate has at least one of the one or more reservoirs which is defined by a closed end wall, an open end, and at least one sidewall extending between the closed end wall and the open end, and

reservoir contents positioned within the at least one reservoir,

wherein the second side of the silicon substrate is hermetically bonded to the primary substrate such that the open end of the reservoir is in fluid communication with the at least one aperture for controlled release or exposure of reservoir contents.

2. A medical implant system comprising:

the containment device of claim 1, which is configured for implantation in a patient; and

an external communicator comprising a second inductive coupling device configured to form an inductive coupling circuit with the first inductive coupling device when brought within proximity of the containment device.

3. The containment device of claim 1, wherein the PCB comprises at least one via configured to electrically connect at least one of the one or more electronic components to the microchip element.

4. The containment device of claim 1, wherein the microchip element is connected via a wire bond to a metallized conductive surface on the PCB.

5. The containment device of claim 4, wherein a biocompatible coating substance is positioned over the wire bond to secure and protect the connection of the wire bond and to create an atraumatic surface about the containment device.

6. The containment device of claim 1, wherein the one or more containment reservoirs comprise microreservoirs containing a drug formulation or a sensor element.

7. The containment device of claim 1, wherein the primary substrate comprises a metal coating over at least a part of the polymer, glass or other ceramic material of the primary substrate.

8. The containment device of claim 7, wherein the metal coating coats the at least one sidewall and/or the closed end wall of the at least one reservoir.

9. The containment device of claim 1, wherein the second side of the silicon substrate comprises at least one ring structure formed thereon.

10. The containment device of claim 9, wherein the at least one ring structure comprises gold or another metal.

11. The containment device of claim 9, wherein the primary substrate comprises at least one groove structure, wherein the at least one ring structure and the at least one groove structure are configured to form a hermetic bond.

12. The containment device of claim 11, wherein the surface of the primary substrate in and/or adjacent to the at least one groove structure comprises a metal coating.

13. The containment device of claim 12, wherein the metal coating comprises gold.

14. The containment device of claim 1, further comprising at least one drug payload disposed in the one or more containment reservoirs for actively controlled release.

15. The containment device of claim 14, wherein a ratio of a volume of the at least one drug payload to a total volume of the containment device is from about 75 μ

L/cc to about 150 μ

L/cc.

16. The containment device of claim 14, wherein a ratio of a volume of the at least one drug payload to a total volume of the containment device is from about 85 μ

L/cc to about 120 μ

L/cc.

17. The containment device of claim 1, which does not include a battery chamber or battery.

18. A method of assembling a containment device, comprising:

providing an elongated microchip element comprising one or more containment reservoirs that are configured to be electrically activated to open;

fixing the elongated microchip element to an electronic printed circuit board (PCB) which comprises a biocompatible substrate;

electrically connecting the elongated microchip element to one or more electronic components; and

incorporating a first inductive coupling device into the microchip element or the PCB, wherein the first inductive coupling device is in communication with the one or more electronic components,

wherein providing the elongated microchip element comprises;

microfabricating a silicon substrate having a first side, an opposed second side, and at least one aperture extending therethrough, wherein the first side comprises an electrically conductive reservoir cap which closes off the at least one aperture;

casting or molding a polymer or a glass or other ceramic material to form a primary substrate having at least one of the one or more reservoirs which is defined by a closed end wall, an open end, and at least one sidewall extending between the closed end wall and the open end;

providing reservoir contents within the at least one reservoir; and

bonding the silicon substrate to the primary substrate such that the open end of the reservoir is in fluid communication with the at least one aperture.

19. The method of claim 18, wherein the microfabricating step further comprises forming at least one ring structure on the second side of the silicon substrate.

20. A system for drug delivery, biosensing, or both drug delivery and biosensing, comprising:

an implantable component which comprises;

a microchip element comprising one or more containment reservoirs that are configured to be electrically activated to open, wherein the microchip element comprises

a silicon substrate having a first side, an opposed second side, and at least one aperture extending therethrough, wherein the first side of the silicon substrate comprises an electrically conductive reservoir cap which closes off the at least one aperture,

a primary substrate which is formed of silicon or other metalloid, a polymer, or a glass or other ceramic material, wherein the primary substrate has at least one of the one or more reservoirs which is defined by a closed end wall, an open end, and at least one sidewall extending between the closed end wall and the open end, and

a drug, a biosensor, or a combination thereof positioned within the at least one reservoir,

wherein the second side of the silicon substrate is hermetically bonded to the primary substrate such that the open end of the reservoir is in fluid communication with the at least one aperture for controlled release of the drug or exposure of the biosensor,

an electronic printed circuit board (PCB) fixed to the microchip element,

one or more electronic components associated with the microchip element or the PCB, and

a first inductive coupling device incorporated into the microchip element or the PCB, wherein the first inductive coupling device is in communication with the one or more electronic components,

wherein the implantable component does not have a housing; and

an external component which comprises a second inductive coupling device configured to form an inductive coupling circuit with the first inductive coupling device when brought within proximity of the implantable component.

21. The system of claim 20, wherein the implantable component is configured for subcutaneous insertion into a patient in need thereof.

22. A containment device, comprising:

a microchip element comprising one or more containment reservoirs that are configured to be electrically activated to open;

a first silicon substrate positioned adjacent to the microchip element;

one or more electronic components disposed within the first silicon substrate, wherein the one or more electronic components are in communication with the microchip element; and

a first inductive coupling device incorporated into the microchip element or the first silicon substrate, wherein the first inductive coupling device is in communication with the one or more electronic components,

wherein the containment device does not have a housing, and

wherein the microchip element comprises

a second silicon substrate having a first side, an opposed second side, and at least one aperture extending therethrough, wherein the first side of the second silicon substrate comprises an electrically conductive reservoir cap which closes off the at least one aperture,

a primary substrate which is formed of silicon or other metalloid, a polymer, or a glass or other ceramic material, wherein the primary substrate has at least one of the one or more reservoirs which is defined by a closed end wall, an open end, and at least one sidewall extending between the closed end wall and the open end, and

reservoir contents positioned within the at least one reservoir,

wherein the second side of the second silicon substrate is hermetically bonded to the primary substrate such that the open end of the reservoir is in fluid communication with the at least one aperture for controlled release or exposure of reservoir contents.

23. A medical implant system comprising:

the containment device of claim 22, which is configured for implantation in a patient; and

an external communicator comprising a second inductive coupling device configured to form an inductive coupling circuit with the first inductive coupling device when brought within proximity of the containment device.

24. A system for drug delivery, biosensing, or both drug delivery and biosensing, comprising:

an implantable component which comprises;

a microchip element comprising one or more containment reservoirs that are configured to be electrically activated to open, wherein the microchip element comprises

a first silicon substrate having a first side, an opposed second side, and at least one aperture extending therethrough, wherein the first side of the first silicon substrate comprises an electrically conductive reservoir cap which closes off the at least one aperture,

a primary substrate which is formed of silicon or other metalloid, a polymer, or a glass or other ceramic material, wherein the primary substrate has at least one of the one or more reservoirs which is defined by a closed end wall, an open end, and at least one sidewall extending between the closed end wall and the open end, and

a drug, a biosensor, or a combination thereof positioned within the at least one reservoir,

wherein the second side of the first silicon substrate is hermetically bonded to the primary substrate such that the open end of the reservoir is in fluid communication with the at least one aperture for controlled release of the drug or exposure of the biosensor,

a second silicon substrate positioned adjacent to the microchip element,

one or more electronic components disposed within the second silicon substrate, wherein the one or more electronic components are in communication with the microchip element, and

a first inductive coupling device incorporated into the microchip element or the second silicon substrate, wherein the first inductive coupling device is in communication with the one or more electronic components,

wherein the implantable component does not have a housing; and

an external component which comprises a second inductive coupling device configured to form an inductive coupling circuit with the first inductive coupling device when brought within proximity of the implantable component.

25. A method, comprising:

implanting a containment device in a patient, wherein the containment device comprises;

a microchip element comprising one or more containment reservoirs that are configured to be electrically activated to open;

an electronic printed circuit board (PCB) fixed to the microchip element;

one or more electronic components associated with the microchip element or the PCB; and

a first inductive coupling device incorporated into the microchip element or the PCB, wherein the first inductive coupling device is in communication with the one or more electronic components,

wherein the implantable component does not have a housing; and

positioning an external communicator comprising a second inductive coupling device configured to form an inductive coupling circuit with the first inductive coupling device within proximity of the containment device,

wherein the microchip element comprises

a silicon substrate having a first side, an opposed second side, and at least one aperture extending therethrough, wherein the first side of the silicon substrate comprises an electrically conductive reservoir cap which closes off the at least one aperture,

a primary substrate which is formed of silicon or other metalloid, a polymer, or a glass or other ceramic material, wherein the primary substrate has at least one of the one or more reservoirs which is defined by a closed end wall, an open end, and at least one sidewall extending between the closed end wall and the open end, and

a drug, a biosensor, or a combination thereof positioned within the at least one reservoir,

wherein the second side of the silicon substrate is hermetically bonded to the primary substrate such that the open end of the reservoir is in fluid communication with the at least one aperture for controlled release of the drug or exposure of the biosensor.

26. An implantable drug delivery device, comprising:

a microchip element comprising at least one containment reservoir that is configured to be electrically activated to open, wherein the microchip element comprises;

a first substrate hermetically bonded to a second substrate, wherein the at least one containment reservoir is defined between the first and second substrates, the reservoir being defined by a closed end wall, an open end, and at least one sidewall extending between the closed end wall and the open end,

a drug positioned within the at least one reservoir, and

an electrically conductive reservoir cap which closes off at least one aperture extending through the first substrate, wherein the open end of the reservoir is in fluid communication with the at least one aperture for controlled release of the drug following said electrical activation; and

an electronic printed circuit board (PCB) fixed to the second substrate of the microchip element, wherein the PCB comprises an alumina or other biocompatible ceramic substrate;

one or more electronic components associated with the microchip element or the PCB; and

a first inductive coupling device incorporated into the microchip element or the PCB, wherein the first inductive coupling device is in communication with the one or more electronic components,

wherein the implantable drug delivery device does not have a metallic housing enclosing the one or more electronic components.