Transcutaneous implant

• US 7,647,097 B2
• Filed: 12/20/2004
• Issued: 01/12/2010
• Est. Priority Date: 12/29/2003
• Status: Active Grant

• Current Assignee: Braingate Incorporated
• Original Assignee: Braingate Co., LLC
• Inventors: Serruya, Mijail D., Flaherty, J. Christopher, Caplan, Abraham H., Guillory, K. Shane
• Primary Examiner(s): Mallari; Patricia C
• Assistant Examiner(s): Toth; Karen E
• Application Number:
  US11/014,907
• Publication Number:
  US 20050283203A1
• Time in Patent Office: 1,849 Days
• Field of Search: 600/372, 600/373, 600/377, 600/378, 600/544, 600/545
• US Class Current: 600/544
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/388 Nerve conduction study, e.g. detecting action potential of peripheral nerves
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/6864 Burr holes
• CPC Class Codes: A61M 2039/025 through bones or teeth, e.g. through the skull
• CPC Class Codes: A61M 2039/0267 comprising sensors or electrical contacts
• CPC Class Codes: A61M 2039/0288 protectors, caps or covers therefor
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Devices, systems and methods are disclosed for a neural access device that includes an implant which transcutaneously exits the skin of a patient and provides transport of signals between a sensor implanted in a patient and an external device. The transcutaneous implant has integrated features to provide reduced risk of injury due to mechanical forces as well as electrostatic discharge energy applied to the external portion of the device. Transcutaneous devices which provide wireless communication between a sensor and an external device are also disclosed.

Claims

1. A neural access device for implanting in a patient comprising:

a sensor comprising a plurality of electrodes to allow for chronic access of cells;

an electrical conduit comprising a plurality of conductors, each conductor electrically connected to one or more of the electrodes;

a connector assembly comprising;

a first portion configured to be placed above a surface of a patient'"'"'s skin;

a second portion configured to be placed beneath the surface of the patient'"'"'s skin;

an attachment member for securing the second portion beneath the surface of the patient'"'"'s skin; and

at least one signal communication port configured to transport a signal to and/or from one or more of the electrodes; and

an electrostatic discharge protector comprising a removable cap covering the at least one signal communication port and configured to protect the device from electrostatic discharge

wherein the signal communication port is configured to transmit cellular activity detected from one or more of the electrodes and electrical signals to one or more of the electrodes

wherein the cellular activity is detected from one or more of the electrodes and the electrical signals are transmitted to at least one of the one or more electrodes from which cellular activity is detected.

2. The device of claim 1, wherein the cap comprises an electrically insulating material.

3. The device of claim 1, wherein the cap comprises an electrically conductive material.

4. The device of claim 1, wherein the cap is attached to the connector assembly by a hinge.

5. The device of claim 4, wherein the hinge is spring-loaded.

6. The device of claim 1, wherein the cap comprises at least one filament attached to the cap.

7. The device of claim 6, wherein the at least one filament is designed to resemble human hair.

8. The device of claim 1, wherein the electrostatic discharge protector comprises an integrated circuit element configured to absorb electrical energy to prevent undesired electrical energy from reaching one or more of the electrodes.

9. The device of claim 1, wherein the electrostatic discharge protector comprises at least two redundant elements each configured to prevent undesired electrical energy from reaching one or more of the electrodes.

10. The device of claim 1, wherein the sensor is configured to detect multicellular signals emanating from the central nervous system.

11. The device of claim 10, wherein the multicellular signals comprise one or more of neuron spikes, electrocorticogram signals, local field potential signals, and electroencephalogram signals.

12. The device of claim 1, wherein the sensor is configured to detect multicellular signals from clusters of neurons and provide signals midway between single neuron and electroencephalogram recordings.

13. The device of claim 1, wherein the sensor is configured to transmit electrical signals to the central nervous system.

14. The device of claim 1, wherein the sensor is configured to both transmit and receive electrical signals.

15. The device of claim 1, wherein the patient is a human being.

16. The device of claim 1, wherein the sensor comprises a multi-electrode array.

17. The device of claim 16, wherein the multi-electrode array comprises a plurality of projections extending from a surface, at least one of the plurality of projections comprises at least one electrode along its length.

18. The device of claim 17, wherein the at least one electrode is located near a distal tip of the projection.

19. The device of claim 17, wherein the at least one electrode comprises at least two electrodes along its length.

20. The device of claim 16, wherein electrodes of the multi-electrode array comprise the same materials of construction.

21. The device of claim 16, wherein the multi-electrode array comprises a first electrode and a second electrode, wherein the first electrode comprises material different from that of the second electrode.

22. The device of claim 16, wherein the multi-electrode array comprises a first electrode and a second electrode, wherein the first electrode has a substantially the same geometrical shape as that of the second electrode.

23. The device of claim 16, wherein the multi-electrode array comprises a first electrode and a second electrode, wherein the first electrode has a geometrical shape different from that of the second electrode.

24. The device of claim 1, wherein the sensor comprises multiple wires or wire bundle electrodes.

25. The device of claim 1, wherein the plurality of electrodes are incorporated into a subdural grid.

26. The device of claim 1, wherein the sensor comprises two or more discrete components, each of the discrete components comprising at least one of the plurality of electrodes.

27. The device of claim 26, wherein the discrete components comprise two or more of the following:

a multi-electrode array;

multiple wires or wire bundles;

a subdural grid; and

scalp electrodes.

28. The device of claim 1, wherein at least one of the plurality of electrodes is implanted near the central nervous system.

29. The device of claim 1, wherein at least one of the plurality of electrodes is implanted within the brain.

30. The device of claim 29, wherein at least one of the plurality of electrodes is implanted within the motor cortex of the brain.

31. The device of claim 1, wherein at least one of the plurality of electrodes is implanted at an extracranial site.

32. The device of claim 1, wherein at least one of the plurality of electrodes is implanted above the patient'"'"'s scalp.

33. The device of claim 1, wherein at least one of the plurality of electrodes is configured to record signals from a plurality of neurons.

34. The device of claim 1, wherein the cells include one or more of nerve cells, muscle cells, organ cells, and tumor cells.

35. The device of claim 1, wherein each of the plurality of conductors is connected to one of the electrodes.

36. The device of claim 1, wherein at least one of the plurality of conductors is connected to more than one electrode.

37. The device of claim 1, wherein the connector assembly is relatively rigid.

38. The device of claim 1, wherein the connector assembly is relatively flexible.

39. The device of claim 1, wherein the connector assembly comprises a relatively rigid portion and a relatively flexible portion.

40. The device of claim 1, wherein the attachment member comprises one or more clearance holes to allow passage of an anchoring device.

41. The device of claim 40, wherein the anchoring device comprises a bone screw.

42. The device of claim 1, wherein the attachment member comprises a woven polyester cuff.

43. The device of claim 1, wherein the at least one signal communication port comprises an electrical contact.

44. The device of claim 1, wherein the at least one signal communication port comprises multiple signal communicator ports comprising electrical contacts.

45. The device of claim 1, further comprising an alignment device configured to align a connecting device in a single orientation to the connector assembly.

46. The device of claim 1, further comprising a controlled device.

47. The device of claim 1, further comprising an engagement member configured to connect the connector assembly to an external mating connector, wherein the engagement member is located at least partially beneath the surface of the patient'"'"'s skin when the device is implanted in the patient.

48. The device of claim 1, wherein the electrical conduit is detachably connected to the connector assembly.

49. The device of claim 1, wherein the connector assembly comprises a flexible sheath configured to exit though the patient'"'"'s skin when the device is implanted in the patient.

50. A neural access device for implanting in a patient comprising:

a sensor comprising a plurality of electrodes to allow for chronic access of cells;

an electrical conduit comprising a plurality of conductors, each conductor electrically connected to one or more of the electrodes;

a connector assembly comprising;

a first portion configured to be placed above a surface of a patient'"'"'s skin;

a second portion configured to be placed beneath the surface of the patient'"'"'s skin;

an attachment member for securing the second portion beneath the surface of the patient'"'"'s skin; and

at least one signal communication port configured to transport a signal to and/or from one or more of the electrodes, and to be placed external to the patient when the device is implanted in the patient

an electrostatic discharge protector configured to protect the device from electrostatic discharge

wherein the signal communication port is configured to transmit cellular activity detected from one or more of the electrodes and electrical signals to one or more of the electrodes

wherein the cellular activity is detected from one or more of the electrodes and the electrical signals are transmitted to at least one of the one or more electrodes from which cellular activity is detected.

51. The device of claim 50, wherein the sensor is configured to detect multicellular signals emanating from the central nervous system.

52. The device of claim 50, wherein the sensor is configured to transmit electrical signals to the central nervous system.

53. The device of claim 50, wherein the plurality of electrodes are incorporated into a subdural grid.

54. The device of claim 50, wherein the at least one signal communication port comprises an electrical contact.

55. The device of claim 50, wherein the at least one signal communication port comprises multiple signal communicator ports comprising electrical contacts.

56. The device of claim 50, wherein the at least one signal communication port comprises an optical port.

57. The device of claim 50, wherein the at least one signal communication port comprises a first signal communication port comprising an electrical contact and a second communication port comprising an optical port.

58. The device of claim 50, wherein the signal communication port is configured to transmit cellular activity detected from one or more of the electrodes.

59. The device of claim 50, wherein the signal communication port is configured to transmit electrical signals to one or more of the electrodes.

60. The device of claim 50, further comprising an engagement member configured to connect the connector assembly to an external mating connector, wherein the engagement member is located at least partially beneath the surface of the patient'"'"'s skin when the device is implanted in the patient.

61. The device of claim 50, wherein the electrical conduit is detachably connected to the connector assembly.

62. The device of claim 50, wherein the connector assembly comprises a flexible sheath configured to exit though the patient'"'"'s skin when the device is implanted in the patient.

63. A neural access device for implanting in a patient comprising:

a sensor comprising a plurality of electrodes to allow for chronic access of cells;

an electrical conduit comprising a plurality of conductors, each conductor electrically connected to one or more of the electrodes;

a connector assembly comprising;

a first portion configured to be placed above a surface of a patient'"'"'s skin;

a second portion configured to be placed beneath the surface of the patient'"'"'s skin;

an attachment member for securing the second portion beneath the surface of the patient'"'"'s skin; and

at least one signal communication port configured to transport a signal to and/or from one or more of the electrodes

an electrostatic discharge protector configured to protect the device from electrostatic discharge

wherein the signal communication port is configured to transmit cellular activity detected from one or more of the electrodes and electrical signals to one or more of the electrodes

wherein the cellular activity is detected from one or more electrodes and the electrical signals are transmitted to at least one of the one or more of the electrodes from which cellular activity is detected.

64. The device of claim 63, wherein the plurality of electrodes are incorporated into a subdural grid.