Implantable biomedical devices on bioresorbable substrates

• US 9,986,924 B2
• Filed: 12/24/2013
• Issued: 06/05/2018
• Est. Priority Date: 03/17/2010
• Status: Active Grant

• Current Assignee: Northwestern University, Trustees of Tufts College, Trustees Of The University Of Pennsylvania (University of Pennsylvania)
• Original Assignee: Board of Trustees of The University of Illinois, Northwestern University, Trustees of Tufts College, Trustees Of The University Of Pennsylvania (University of Pennsylvania)
• Inventors: Rogers, John A., Kim, Dae-Hyeong, Omenetto, Fiorenzo, Kaplan, David L., Litt, Brian, Viventi, Jonathan, Huang, Yonggang, Amsden, Jason
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US14/140,299
• Publication Number:
  US 20140163390A1
• Time in Patent Office: 1,624 Days
• Field of Search: 600372, 600373, 600377, 600395
• CPC Class Codes: A61B 2562/0285 Nanoscale sensors
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/6867 specially adapted to be attached or implanted in a specific body part A61B5/6847 takes precedence
• CPC Class Codes: A61L 31/047 Other specific proteins or polypeptides not covered by A61L31/044 - A61L31/046
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: B82Y 15/00 Nanotechnology for interacting, sensing or actuating, e.g. quantum dots as markers in protein assays or molecular motors
• CPC Class Codes: H01L 2924/00 Indexing scheme for arrangements or methods for connecting or disconnecting semiconductor or solid-state bodies as covered by H01L24/00
• CPC Class Codes: H01L 2924/0002 Not covered by any one of groups H01L24/00, H01L24/00 and H01L2224/00
• CPC Class Codes: H05K 1/0283 Stretchable printed circuits
• CPC Class Codes: H05K 3/20 by affixing prefabricated conductor pattern H05K1/187, H05K3/046, H05K3/4658, H05K3/4682 takes precedence

Abstract

Provided herein are implantable biomedical devices and methods of administering implantable biomedical devices, making implantable biomedical devices, and using implantable biomedical devices to actuate a target tissue or sense a parameter associated with the target tissue in a biological environment.

Claims

1. An implantable biomedical device for actuating a target tissue or sensing a parameter associated with the target tissue in a biological environment, said device comprising:

a bioresorbable substrate;

an electronic device comprising one or more metallic conductor components including at least one electrode supported by said bioresorbable substrate, wherein at least one of said metallic conductor components has at least one physical dimension less than or equal to 100 microns;

a barrier layer encapsulating at least a portion of said metallic conductor components; and

a transmitter or a receiver operationally connected to said one or more metallic conductor components;

wherein said bioresorbable substrate, said electronic device, and said barrier layer provide a net bending stiffness of the implantable biomedical device of less than 1×

10⁹ GPa μ

m⁴; and

wherein upon contact with said biological environment said bioresorbable substrate is at least partially resorbed, and the Young'"'"'s modulus of the implantable biomedical device decreases by at least 20% upon complete or partial resorption of the bioresorbable substrate, thereby establishing an interface providing for conformal contact between said electronic device and said target tissue.

2. The device of claim 1 further comprising a biocompatible layer provided on said bioresorbable substrate, wherein the biocompatible layer is positioned between the electronic device and the bioresorbable substrate.

3. The device of claim 1, wherein said bioresorbable substrate, said barrier layer or both said bioresorbable substrate and said barrier layer have a substantially planar contact surface for contacting said target tissue.

4. The device of claim 1, wherein said bioresorbable substrate is configured to be completely resorbed upon contact with said biological environment.

5. The device of claim 1, wherein said bioresorbable substrate is configured not to be completely resorbed upon contact with said biological environment.

6. The device of claim 1, wherein said at least partial resorption of the bioresorbable substrate establishes an interface providing for physical contact, electrical contact, thermal contact and/or optical communication between said electronic device and said target tissue.

7. The device of claim 1, wherein resorption of said bioresorbable substrate provides the electronic device in optical communication with said target tissue.

8. The device of claim 1, wherein said bioresorbable substrate comprises a biopolymer, a synthetic polymer, a protein, a polysaccharide, silk, a poly(glycerol-sebacate) (PGS), polydioxanone, poly(lactic-co-glycolic acid) (PLGA), polylactic acid (PLA), collagen, chitosan, fibroin, silkworm fibroin, modified silkworm fibroin, spider silk, insect silk, recombinant silk, or any combination of these.

9. The device of claim 1, wherein said bioresorbable substrate has

(i) a Young'"'"'s modulus selected from the range of 0.5 MPa to 10 GPa;

(ii) a thickness selected from the range of 100 nanometers to 10000 μ

m;

(iii) a net bending stiffness selected from the range of 0.1×

10⁴ GPa μ

m⁴ to 1×

10⁹ GPa μ

m⁴;

or

(iv) a degree of crystallinity selected over the range of 0 to 55%.

10. The device of claim 1, wherein said implantable biomedical device has a neutral mechanical plane and at least a portion of said one or more metallic conductor components is positioned proximate to said neutral mechanical plane.

11. The device of claim 1, wherein at least one of said one or more metallic conductor components is a flexible structure or a stretchable structure.

12. The device of claim 1, wherein at least one of said one or more metallic conductor components of the electronic device has a thickness less than or equal to 10 microns or lateral dimensions less than or equal to 10000 microns.

13. The device of claim 1, wherein said one or more metallic conductor components form an array, wherein said one or more metallic conductor components are physically separated from each other.

14. The device of claim 13, wherein each of said one or more metallic conductor components of said array is in electrical contact with at least one electronic interconnect.

15. The device of claim 13, wherein adjacent metallic conductor components in said array are separated from each other by a distance selected from the range of 10 microns to 10 millimeters.

16. The device of claim 13, wherein said array comprises 10 to 1000 metallic conductor components.

17. The device of claim 1, wherein said one or more metallic conductor components comprise a bioinert metal or a biocompatible metal.

18. The device of claim 1, wherein said one or more metallic conductor components comprise a bioinert metal selected from the group consisting of titanium, gold, silver, platinum, and any combination of these.

19. The device of claim 1, wherein said one or more metallic conductor components comprise a biocompatible metal selected from the group consisting of iron, magnesium, and any combination of these.

20. The device of claim 1, wherein said barrier layer has a mesh structure.

21. The device of claim 20, wherein said mesh structure is a perforated mesh structure or a tentacle mesh structure.

22. The device of claim 1, wherein said barrier layer is in physical contact with at least a portion of said metallic conductor components or wherein said bioresorbable substrate is in physical contact with at least a portion of said metallic conductor components or in physical contact with at least a portion of said barrier layer.

23. The device of claim 1, wherein said barrier layer has a thickness selected from the range of 1 μ

m to 100 μ

m.

24. The device of claim 1, wherein said barrier layer is configured as a discontinuous layer.

25. The device of claim 1, wherein said barrier layer comprises a material selected from the group consisting of SU-8, an insulator, a polyimide, a dielectric, an inorganic dielectric and any combination of these.

26. The device of claim 1, wherein said barrier layer encapsulates all of the metallic conductor components of the electronic device.

27. The device of claim 1, wherein said barrier layer completely encapsulates the electronic device.

28. The device of claim 1, wherein said barrier layer limits net leakage current from said electronic device to 10 μ

A/μ

m² or less.

29. The device of claim 1, wherein said barrier layer comprises a bioresorbable material or a bioinert material.

30. A method for administering an implantable biomedical device, said method comprising:

providing the implantable biomedical device comprising;

a bioresorbable substrate;

an electronic device comprising one or more metallic conductor components supported by said bioresorbable substrate, wherein at least one of said metallic conductor components has at least one physical dimension less than or equal to 100 microns;

a barrier layer encapsulating at least a portion of said metallic conductor components;

wherein said bioresorbable substrate, said electronic device, and said barrier layer provide a net bending stiffness of the implantable biomedical device of less than 1×

10⁹ GPa μ

m⁴; and

a transmitter or a receiver operationally connected to said one or more metallic conductor components and

contacting said one or more metallic conductor components with a target tissue in a biological environment;

wherein upon contact with said biological environment said bioresorbable substrate is at least partially resorbed, the Young'"'"'s modulus of the implantable biomedical device decreases by at least 20% upon complete or partial resorption of the bioresorbable substrate thereby establishing an interface providing for conformal contact between said electronic device and said target tissue.

31. The method of claim 30, wherein the Young'"'"'s modulus or the net bending stiffness of said implantable biomedical device decreases by at least 50% upon resorption of the bioresorbable substrate.

32. The method of claim 30, further comprising sensing a parameter associated with the target tissue in contact with the implantable biomedical device by measuring voltage at a surface of the target tissue, measuring electromagnetic radiation at the surface of the target tissue or measuring a current at the surface of the target tissue.

33. The method of claim 30, further comprising actuating the target tissue in contact with the implantable biomedical device by generating a voltage at a surface of the target tissue, generating electromagnetic radiation at the surface of the target tissue or generating a current at the surface of the target tissue.