System, devices, and methods including actively-controllable electromagnetic energy-emitting delivery systems and energy-activateable disinfecting agents

• US 20090177139A1
• Filed: 12/04/2008
• Published: 07/09/2009
• Est. Priority Date: 08/17/2007
• Status: Abandoned Application

• Current Assignee: Searete LLC (Intellectual Ventures LLC)
• Original Assignee: Searete LLC (Intellectual Ventures LLC)
• Inventors: Dacey, Ralph G. JR., Ishikawa, Muriel Y., Smith, Michael A., Myhrvold, Nathan P., Tegreene, Clarence T., Boyden, Edward S., Wood, Lowell L. JR., Rivet, Dennis J., Hyde, Roderick A., Kare, Jordin T., Sweeney, Elizabeth A., Wood, Victoria Y.H., Leuthardt, Eric C., Santiago, Paul, Stewart, Todd J., Dowling, Joshua L., Rocca, Gregory J. Della
• Application Number:
  US12/315,883
• Publication Number:
  US 20090177139A1
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61F 2/30 Joints
• CPC Class Codes: A61F 2/32 for the hip
• CPC Class Codes: A61F 2/48 Operating or control means, e.g. from outside the body, control of sphincters
• CPC Class Codes: A61F 2/481 Acoustic or audible means
• CPC Class Codes: A61F 2/482 Electrical means
• CPC Class Codes: A61F 2002/30087 piezoelectric
• CPC Class Codes: A61F 2002/3067 for data transfer
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2250/0002 for data transfer
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61L 2/0011 using physical methods
• CPC Class Codes: A61L 2/08 Radiation
• CPC Class Codes: A61L 2/14 Plasma, i.e. ionised gases
• CPC Class Codes: A61L 2202/14 Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: A61M 5/001 Apparatus specially adapted for cleaning or sterilising syringes or needles
• CPC Class Codes: A61N 1/205 for promoting a biological process
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 1/3785 generated by biological activity or substance, e.g. body movement
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Systems, devices, methods, and compositions are described for providing an actively-controllable disinfecting implantable device configured to, for example, treat or prevent an infection in a biological subject.

Claims

1. A system, comprising:

an implantable medical device, the implantable medical device including a body having at least one outer surface, the implantable medical device including

one or more energy-emitting elements;

a disinfecting agent assembly including at least one disinfecting active agent reservoir, the disinfecting agent assembly configured to deliver at least one energy-activateable disinfecting agent from the at least one disinfecting active agent reservoir to at least a portion of tissue proximate the at least one outer surface of the implantable medical device; and

a controller operably coupled to the one or more energy-emitting elements.

3. The system of claim 1, wherein the one or more energy-emitting elements are configured to emit electromagnetic radiation having a peak emission wavelength in the x-ray, ultraviolet, visible, infrared, near infrared, microwave, or radio frequency spectrum, or combinations thereof.

4. The system of claim 1, wherein the one or more energy-emitting elements are configured to provide a spatially-patterned sterilizing stimulus.

5. The system of claim 1, wherein the one or more energy-emitting elements are configured to provide a sterilizing stimulus pattern comprising at least a first region and a second region, the second region having at least one of an illumination intensity, an energy-emitting pattern, a peak emission wavelength, an ON-pulse duration, an OFF-pulse duration, or a pulse frequency different than the first region.

6. The system of claim 1, wherein the one or more energy-emitting elements are operable to emit a sufficient amount of electromagnetic radiation to increase the temperature of at least a portion of the tissue proximate the at least one outer surface of the implantable medical device by about 5°

C. to about 20°

C.

9. The system of claim 1, wherein the at least one energy-activateable disinfecting agent includes at least one photoactive agent, or a metabolic precursor thereof.

10. The system of claim 1, wherein the at least one energy-activateable disinfecting agent includes at least one X-ray absorber.

11. The system of claim 1, wherein the at least one energy-activateable disinfecting agent includes at least one radiation absorber.

12. The system of claim 1, wherein the at least one energy-activateable disinfecting agent includes at least one active agent that selectively targets bacteria.

13. The system of claim 1, wherein the disinfecting agent assembly is configured to deliver the at least one energy-activateable disinfecting agent in a spatially-patterned distribution.

14. The system of claim 1, wherein the controller is operably coupled to the disinfecting agent assembly and configured to control at least one of a disinfecting agent delivery rate, a disinfecting agent delivery amount, a disinfecting agent delivery composition, a port release rate, a port release amount, or a port release pattern.

15. The system of claim 13, wherein the implantable medical device includes a plurality of spaced apart release ports adapted to deliver the at least one energy-activateable disinfecting agent in a spatially-patterned distribution.

16. The system of claim 15, wherein the controller is operably coupled to the disinfecting agent assembly and configured to actively control one or more of the plurality of spaced apart release ports.

18. The system of claim 1, wherein the disinfecting agent assembly is further configured to deliver at least one energy-activateable steroid to tissue proximate the at least one outer surface of the implantable medical device.

20. The system of claim 1, further comprising:

a power source, the power source including at least one of a thermoelectric generator, piezoelectric generator, a microelectromechanical systems (MEMS) generator, or a biomechanical-energy harvesting generator.

26. The system of claim 1, further comprising:

one or more sensors configured to determine at least one characteristic associated with the tissue proximate the at least one outer surface.

29. The system of claim 26, wherein the at least one characteristic associated with the tissue proximate the at least one outer surface includes at least one parameter associated with at least one of an amount of energy-activateable disinfecting agent present in at least a portion of the tissue proximate the at least one outer surface, a sodium ion content, a chloride content, a superoxide anion content, or a hydrogen peroxide content.

30. The system of claim 26, wherein the at least one characteristic associated with the tissue proximate the at least one outer surface includes at least one of an absorption coefficient, an extinction coefficient, or a scattering coefficient.

33. The system of claim 26, wherein the at least one characteristic associated with the tissue proximate the at least one outer surface includes at least one parameter associated with a tissue water content, an oxy-hemoglobin concentration, a deoxyhemoglobin concentration, an oxygenated hemoglobin absorption parameter, a deoxygenated hemoglobin absorption parameter, a tissue light scattering parameter, a tissue light absorption parameter, a hematological parameter, or a pH level.

34. The system of claim 26, wherein the at least one characteristic associated with the tissue proximate the at least one outer surface includes at least one parameter associated with a cytokine plasma concentration or an acute phase protein plasma concentration.

36. The system of claim 26, wherein the at least one characteristic associated with the tissue proximate the at least one outer surface includes at least one of a transmittance, an interrogation energy frequency change, a frequency shift, an interrogation energy phase change, or a phase shift.

37. The system of claim 26, wherein the at least one characteristic associated with the tissue proximate the at least one outer surface includes at least one of a fluorescence, and intrinsic fluorescence, a tissue fluorescence, or a naturally occurring fluorophore fluorescence.

38. The system of claim 26, wherein the at least one characteristic associated with the tissue proximate the at least one outer surface includes at least one of an electrical conductivity, and electrical polarizability, or an electrical permittivity.

39. The system of claim 26, wherein the at least one characteristic associated with the tissue proximate the at least one outer surface includes at least one of a thermal conductivity, a thermal diffusivity, a tissue temperature, or a regional temperature.

40. The system of claim 26, wherein the at least one characteristic associated with the tissue proximate the at least one outer surface at least one of an absorption coefficient, an extinction coefficient, a scattering coefficient, a transmission coefficient, a frequency change, a reflection, a phase change, or ultrasonic energy phase change.

41. The system of claim 26, further comprising:

one or more processors configured to perform a comparison of the at least one characteristic associated the tissue proximate the at least one outer surface to stored reference data following delivery of the sterilizing stimulus, and to generate a response based at least in part on the comparison.

42. The system of claim 26, wherein the generated response includes at least one of a response signal, a control signal, a change to an sterilizing stimulus parameter, a change in an excitation intensity, a change in an excitation frequency, a change in an excitation pulse frequency, a change in an excitation pulse ratio, a change in an excitation pulse intensity, a change in an excitation pulse duration time, a change in an excitation pulse repetition rate, a change to a sterilizing stimulus spatial pattern, or a change in an sterilizing stimulus delivery regiment parameter.

44. The system of claim 26, wherein the controller is configured to perform a comparison of the at least one characteristic associated with the tissue proximate the at least one outer surface to stored reference data, and to generate a response based at least in part on the comparison.

45. The system of claim 26, further comprising:

one or more processors configured to perform a comparison of the at least one characteristic associated with the tissue proximate the at least one outer surface to stored reference data, and to generate a response based at least in part on the comparison.

47. The system of claim 1, further comprising:

circuitry for obtaining information; and

circuitry for storing the obtained information.

48. The system of claim 47, further comprising:

one or more processors configured to perform a comparison of the determined at least one physiological characteristic of the biological subject to the obtained information, and to generate a response based at least in part on the comparison.

49. The system of claim 47, wherein the circuitry for obtaining information includes circuitry for obtaining information associated with a delivery of the sterilizing stimulus.

50. The system of claim 47, wherein the circuitry for obtaining information includes circuitry for obtaining at least one of a command stream, a software stream, or a data stream.

51. The system of claim 1, further comprising:

at least one receiver configured to acquire information.

52. The system of claim 51, wherein the at least one receiver is configured to acquire at least one of instructions, information associated with a delivery of the sterilizing stimulus, information associated with a physiological characteristic of a biological subject, acquire software.

53. The system of claim 51, wherein the at least one receiver is configured to acquire data from one or more distal sensors.

54. The system of claim 51, wherein the at least one receiver is configured to acquire stored reference data.

55. The system of claim 1, further comprising:

circuitry for providing information.

56. The system of claim 55, wherein the circuitry for providing information includes circuitry for providing information regarding at least one characteristic associated with a tissue proximate the first outer surface.

57. The system of claim 55, further comprising:

at least one transmitter configured to send information.

58. The system of claim 1, wherein the disinfecting agent assembly is further configured to deliver one or more tracer agents.

59. The system of claim 1, wherein the one or more tracer agents include one or more in vivo clearance agents, magnetic resonance imaging agents, contrast agents, dye-peptide compositions, fluorescent dyes, or tissue specific imaging agents.

62. The system of claim 1, wherein the disinfecting agent assembly is further configured to deliver one or more tracer agents for indicating the presence or concentration of one or more one energy-activateable disinfecting agents in at least a portion of tissue proximate the implantable medical device.

63. The system of claim 1, wherein the disinfecting agent assembly is further configured to deliver one or more tracer agents for indicating the response of the one or more one energy-activateable disinfecting agents to energy emitted from the one or more energy-emitting elements.

64. The system of claim 1, wherein the disinfecting agent assembly is further configured to concurrently or sequentially deliver one or more tracer agents and the one or more one energy-activateable disinfecting agents.

2. (canceled)

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27. (canceled)

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61. (canceled)

65. A method of treating scar formation post surgery, comprising:

implanting or inserting a surgical implant comprising a photoactivateable steroid composition into a biological subject; and

photoactivating the photoactivateable steroid composition.

66. The method of claim 65, wherein photoactivating the photoactivateable steroid composition includes controlling an actively-controllable excitation component so as to deliver a sterilizing stimulus of a character and for a time sufficient to photoactivate at least a portion of the photoactivateable steroid composition.

67. The method of claim 65, wherein implanting or inserting the surgical implant includes implanting or inserting a surgical implant comprising a photoactivateable steroid composition including one or more growth promoting materials.

68. The method of claim 65, wherein photoactivating the photoactivateable steroid composition includes controlling an actively-controllable excitation component so as to deliver a sterilizing stimulus of a character and for a time sufficient to stimulate non-scaring tissue formation.

69. The method of claim 65, further comprising:

concurrently or sequentially delivering a first electrical stimulus and a second electrical stimulus, in vivo, to target tissue proximate the implanted or inserted surgical implant, the first electrical stimulus or the second electric stimulus of a character and duration to inhibit growth of tissue of a first type, and the other of the first electrical stimulus or the second electric stimulus of a character and duration to promote growth of tissue of a second type.

70. The method of claim 65, further comprising:

concurrently or sequentially delivering a first electrical stimulus and a second electrical stimulus, in vivo, to target tissue proximate the implanted or inserted surgical implant, the first electrical stimulus or the second electric stimulus of a character and duration to inhibit scar formation, and the other of the first electrical stimulus or the second electric stimulus of a character and duration to promote growth of tissue.

71. The method of claim 65, further comprising:

concurrently or sequentially delivering a spatially patterned electrical stimulus including a first electrical stimulus and a second electrical stimulus, in vivo, to target tissue proximate the implanted or inserted surgical implant, the first electrical stimulus or the second electric stimulus of a character and duration to inhibit scar formation in a first region proximate the implanted device and the other of the first electrical stimulus or the second electric stimulus of a character and duration to promote growth of tissue in a second region proximate the implanted, the second region differing in at least one of area, volume, or location of the first region.

72. A method of treating scar formation post surgery, comprising:

photoactivating a photoactivateable steroid composition carried by an implanted surgical implant.

73. The method of claim 72, wherein photoactivating the photoactivateable steroid composition includes activating an actively-controllable excitation component to deliver a space-apart light energy patterned having a sufficient strength or duration to photoactivate at least a portion of the photoactivateable steroid composition.