System, devices, and methods including actively-controllable sterilizing excitation delivery implants

• US 9,005,263 B2
• Filed: 12/03/2009
• Issued: 04/14/2015
• Est. Priority Date: 08/17/2007
• Status: Expired due to Fees

• Current Assignee: Gearbox LLC (Intellectual Ventures LLC)
• Original Assignee: The Invention Science Fund I, L.L.C. (Intellectual Ventures LLC)
• Inventors: Boyden, Edward S., Dacey, Ralph G. Jr., Della Rocca, Gregory J., Dowling, Joshua L., Hyde, Roderick A., Ishikawa, Muriel Y., Kare, Jordin T., Leuthardt, Eric C., Myhrvold, Nathan P., Rivet, Dennis J., Santiago, Paul, Smith, Michael A., Stewart, Todd J., Sweeney, Elizabeth A., Tegreene, Clarence T., Wood, Lowell L. Jr., Wood, Victoria Y. H.
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): SMITH, KAITLYN ELIZABETH
• Application Number:
  US12/592,976
• Publication Number:
  US 20100174346A1
• Time in Patent Office: 1,958 Days
• Field of Search: 607/96
• US Class Current: 607/96
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/30 Joints
• CPC Class Codes: A61F 2/481 Acoustic or audible means
• CPC Class Codes: A61F 2/482 Electrical means
• CPC Class Codes: A61F 2002/009 for hindering or preventing attachment of biological tissue
• 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 2002/3068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2002/3084 Nanostructures
• CPC Class Codes: A61F 2002/30932 for retarding or preventing ingrowth of bone tissue
• CPC Class Codes: A61F 2250/0002 for data transfer
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2310/00616 Coating made of titanium oxide or hydroxides
• CPC Class Codes: A61L 2/0011 using physical methods
• CPC Class Codes: A61L 2/0023 Heat
• CPC Class Codes: A61L 2/0029 Radiation
• CPC Class Codes: A61L 2/0088 Liquid substances
• CPC Class Codes: A61L 2/025 Ultrasonics
• CPC Class Codes: A61L 2/03 Electric current
• CPC Class Codes: A61N 1/205 : for promoting a biological process
• 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. An implantable device, comprising:

an actively-controllable excitation component configured to deliver a pulsed thermal sterilizing stimulus, in vivo, to a region proximate a surface of the implantable device;

at least one scaffold-forming material reservoir including one or more controllable-release ports operable to deliver a scaffold-forming material from the at least one scaffold-forming material reservoir to a region proximate a surface of the implantable device;

a control means operably coupled to the actively-controllable excitation component and configured to regulate at least one of a delivery regimen parameter, a spaced-apart delivery pattern parameter, and a temporal delivery pattern parameter associated with the delivery of the pulsed thermal sterilizing stimulus; and

a control means configured to control at least one component associated with delivery of the scaffold-forming material from the at least one scaffold-forming material reservoir to a region proximate a surface of the implantable device.

2. The implantable device of claim 1, wherein the actively-controllable excitation component is configured to deliver a pulsed thermal sterilizing stimulus including at least a first pulsed waveform segment and a second pulsed waveform segment, the second pulsed waveform segment having at least one of a pulse duration, a pulse frequency, a pulse intensity, a pulse ratio, or a pulse repetition rate different from the first pulsed waveform segment.

3. The implantable device of claim 2, wherein the control means is configured to control one or more parameters associated with at least one of a pulse duration, a pulse frequency, a pulse intensity, a pulse ratio, or a pulse repetition rate associated with at least one of the first pulsed waveform segment or the second pulsed waveform segment.

4. The implantable device of claim 1, wherein the actively-controllable excitation component is configured to deliver at least one of a spatially-patterned pulsed thermal sterilizing stimulus or a temporally-patterned pulsed thermal sterilizing stimulus.

5. The implantable device of claim 1, wherein the actively-controllable excitation component is configured to concurrently or sequentially provide at least a first pulsed thermal sterilizing stimulus and a second pulsed thermal sterilizing stimulus, the second pulsed thermal sterilizing stimulus having at least one of a duration, a frequency, or an intensity different from the first pulsed thermal sterilizing stimulus.

6. The implantable device of claim 1, wherein the actively-controllable excitation component is configured to concurrently or sequentially provide at least a first pulsed thermal sterilizing stimulus and a second pulsed thermal sterilizing stimulus, the second pulsed thermal sterilizing stimulus having a spatial pattern different from the first pulsed thermal sterilizing stimulus.

7. The implantable device of claim 1, wherein the actively-controllable excitation component is configured to deliver a pulsed thermal sterilizing stimulus of a character and for a duration sufficient to induce a temperature gradient in one or more regions proximate a first outer surface.

8. The implantable device of claim 1, further comprising:

one or more sensors configured to determine at least one characteristic associated with a biological sample proximate the first outer surface.

9. The implantable device of claim 8, wherein the control means is configured to change at least one of the delivery regimen parameter, the spaced-apart delivery pattern parameter, or the temporal delivery pattern parameter in response to a comparison between one or more real-time measurands associated with a tissue proximate the first outer surface and user specific information.

10. The implantable device of claim 8, wherein the one or more sensors are configured to determine a spatial dependence associated with the at least one characteristic associated with the biological sample proximate the first outer surface.

11. The implantable device of claim 8, wherein the one or more sensors are configured to determine a temporal dependence associated with at least one characteristic associated with the biological sample proximate the first outer surface.

12. The implantable device of claim 8, wherein the at least one characteristic associated with the biological sample proximate the first outer surface includes at least one of a thermal conductivity, a thermal diffusivity, a tissue temperature, or a regional temperature.

13. The implantable device of claim 8, wherein the at least one characteristic associated with biological sample proximate the first outer surface includes a phase change to an interrogation energy stimulus.

14. The implantable device of claim 8, wherein the at least one characteristic associated with the biological sample proximate the first outer surface includes a refractive index parameter.

15. The implantable device of claim 8, wherein the control means is operably coupled to at least a first sensor and at least a second sensor, and is configured to generate a comparison of first sensor data to second sensor data and to generate predictive information based on the comparison.

16. The implantable device of claim 8, wherein the control means is configured to perform a comparison of the at least one characteristic associated with the biological sample proximate the first outer surface to stored reference data and to generate a response based at least in part on the comparison.

17. The implantable device of claim 1, further comprising:

a power source, the power source including at least one of a thermoelectric generator, a piezoelectric generator, an electromechanical generator, or a biomechanical-energy harvesting generator.

18. The implantable device of claim 17, further comprising:

at least one of a battery, a capacitor, and a mechanical energy store.

19. The implantable device of claim 1, further comprising:

a transcutaneous energy transfer system, the transcutaneous energy transfer system electromagnetically, magnetically, ultrasonically, optically, inductively, electrically, or capacitively-coupled to the actively-controllable excitation component.

20. The implantable device of claim 1, further comprising:

a power receiver configured to receive power from an ex vivo power source.

21. The implantable device of claim 1, further comprising:

a power receiver configured to receive power from an in vivo power source.

22. The implantable device of claim 1, further comprising:

a transmitter.

23. An indwelling medical implant, comprising:

a sensor component configured to perform a real-time comparison of a measurand associated with a biological sample proximate one or more regions of at least one surface of the indwelling implant to stored reference data;

one or more energy emitters configured to emit a pulsed thermal sterilizing stimulus of a character and for a time sufficient to induce apoptosis without substantially inducing necrosis of at least a portion of cells proximate the indwelling medical implant in response to the comparison; and

at least one scaffold-forming material reservoir operable to deliver a scaffold-forming material from the at least one scaffold-forming material reservoir to a region proximate a surface of the implantable device.

24. The indwelling medical implant of claim 23, wherein at least one of the one or more energy emitters is configured to emit a pulsed thermal sterilizing stimulus of a character and for a time sufficient to induce apoptosis without substantially inducing necrosis of an infectious agent within a tissue proximate the indwelling medical implant in response to a detected level of an infectious agent.

25. The indwelling medical implant of claim 23, wherein at least one of the one or more energy emitters is configured to emit a pulsed thermal sterilizing stimulus of a character and for a time sufficient to induce apoptosis without substantially inducing necrosis of a pathogen within a region proximate the indwelling medical implant.

26. The indwelling medical implant of claim 23, wherein the one or more energy emitters are operable to emit a sufficient amount of a pulsed thermal sterilizing stimulus to increase the temperature of at least a portion of cells proximate the indwelling medical implant by about 3°

C. to about 22°

C.

27. An implantable system, comprising:

circuitry for delivering a pulsed thermal sterilizing stimulus, in vivo, to a region proximate a surface of an indwelling medical implant, the pulsed thermal sterilizing stimulus of a character and for a time sufficient to induce apoptosis without substantially inducing necrosis of at least a portion of cells within the region proximate the indwelling medical implant;

circuitry for regulating at least one parameter associated with the delivery of the pulsed thermal sterilizing stimulus in response to a determination that an infectious agent is present within the region proximate the indwelling medical implant; and

circuitry for controlling at least one parameter associated with a delivery of a scaffold-forming material to a region proximate a surface of an indwelling medical implant.

28. The implantable system of claim 27, wherein the circuitry for delivering the pulsed thermal sterilizing stimulus includes one or more energy emitters configured to deliver a pulsed thermal sterilizing stimulus of a character and for a time sufficient to induce apoptosis without substantially inducing necrosis of the at least a portion of cells proximate the indwelling medical implant.

29. The implantable system of claim 27, wherein the circuitry for delivering the pulsed thermal sterilizing stimulus includes an actively-controllable excitation component configured to deliver a spatially-focused pulsed thermal sterilizing stimulus.

30. The implantable system of claim 27, wherein the circuitry for delivering the pulsed thermal sterilizing stimulus includes an actively-controllable excitation component configured to deliver a spatially-collimated pulsed thermal sterilizing stimulus.

31. The implantable system of claim 27, wherein the circuitry for delivering the pulsed thermal sterilizing stimulus includes an actively-controllable excitation component configured to deliver at least one of a spatially-patterned pulsed thermal sterilizing stimulus or a temporally-patterned pulsed thermal sterilizing stimulus.

32. The implantable system of claim 27, wherein the circuitry for regulating the at least one parameter associated with the delivery of the pulsed thermal sterilizing stimulus is operably coupled to the circuitry for delivering the pulsed thermal sterilizing stimulus and configured to control at least one of a pulsed thermal sterilizing stimulus delivery regimen parameter, a spaced-apart pulsed thermal sterilizing stimulus delivery pattern parameter, or a pulsed thermal sterilizing stimulus temporal delivery pattern parameter.

33. The implantable system of claim 27, wherein the circuitry for regulating the at least one parameter associated with the delivery of the pulsed thermal sterilizing stimulus is configured to control at least one of a pulsed thermal sterilizing stimulus delivery regimen parameter, a pulsed thermal sterilizing stimulus temporal delivery pattern parameter, or a spaced-apart pulsed thermal sterilizing stimulus delivery pattern parameter associated with the delivery of the pulsed thermal sterilizing stimulus.