Systems, devices, and methods including infection-fighting and monitoring shunts

• US 8,343,086 B2
• Filed: 05/21/2010
• Issued: 01/01/2013
• Est. Priority Date: 08/17/2007
• Status: Active Grant

• Current Assignee: Gearbox LLC (Intellectual Ventures LLC)
• Original Assignee: The Invention Science Fund I, L.L.C. (Intellectual Ventures LLC)
• Inventors: Dacey, Ralph G. Jr., Hyde, Roderick A., Ishikawa, Muriel Y., Kare, Jordin T., Leuthardt, Eric C., Myhrvold, Nathan P., Rivet, Dennis J., Smith, Michael A., Sweeney, Elizabeth A., Tegreene, Clarence T., Wood, Lowell L. Jr., Wood, Victoria Y. H.
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US12/800,790
• Publication Number:
  US 20100241053A1
• Time in Patent Office: 956 Days
• Field of Search: 604/6.08, 604/8, 604/9, 604/20
• US Class Current: 604/8
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• 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 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• 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
• CPC Class Codes: A61N 1/40 : Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 2005/0651 : Diodes
• CPC Class Codes: A61N 2005/0652 : Arrays of diodes
• CPC Class Codes: A61N 2005/0661 : ultraviolet
• CPC Class Codes: A61N 5/02 : using microwaves
• CPC Class Codes: A61N 5/0601 : Apparatus for use inside the body
• CPC Class Codes: A61N 5/0624 : for eliminating microbes, germs, bacteria on or in the body
• CPC Class Codes: A61N 5/10 : X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy A61N5/01 takes precedence
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

Systems, devices, methods, and compositions are described for providing an actively controllable shunt configured to, for example, monitor, treat, or prevent an infection.

Claims

1. An implantable shunt system, comprising:

a body structure having a surface defining one or more fluid-flow passageways configured to receive a biological fluid of a biological subject; and

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 within the biological fluid proximate the surface of the body structure in response to a real-time detected change of an index of refraction parameter associated with the biological fluid within the interior of at least one fluid passageway, wherein the change in the index of refraction parameter is an indication of an infectious agent within the biological fluid.

2. The implantable shunt system of claim 1, wherein the one or more energy emitters are configure to emit a sufficient amount of a pulsed thermal sterilizing stimulus to increase the temperature of at least a portion of a cerebrospinal fluid received within at least one of the one or more fluid-flow passageways by about 3 °

C. to about 22°

C.

3. The implantable shunt system of claim 1, wherein the one or more energy emitters are configure to emit a sufficient amount of a pulsed thermal sterilizing stimulus to increase the temperature of at least a portion of a cerebrospinal fluid received within at least one of the one or more fluid-flow passageways by about 3 °

C. to about 10°

C.

4. The implantable shunt system of claim 1, wherein the one or more energy emitters are configure to emit a sufficient amount of a pulsed thermal sterilizing stimulus to increase the temperature of at least a portion of cells within a cerebrospinal fluid received within at least one of the one or more fluid-flow passageways by about 3°

C. to about 4 °

C.

5. The implantable shunt system of claim 1, wherein at least one of the one or more energy emitters is configured to deliver a pulsed thermal sterilizing stimulus of a character and for a duration sufficient to elevate a temperature at least a portion of cells within a cerebrospinal fluid received within at least one of the one or more fluid-flow passageways from about 37 °

C. to less than about 60 °

C.

6. The implantable shunt system of claim 1, wherein at least one of the one or more energy emitters is configured to deliver a pulsed thermal sterilizing stimulus of a character and for a duration sufficient to elevate a temperature at least a portion of cells within a cerebrospinal fluid received within at least one of the one or more fluid-flow passageways from about 37 °

C. to less than about 47 °

C.

7. The implantable shunt system of claim 1, wherein at least one of the one or more energy emitters is configured to deliver a pulsed thermal sterilizing stimulus of a character and for a duration sufficient to elevate a temperature of at least a portion of cells within a cerebrospinal fluid received within at least one of the one or more fluid-flow passageways from about 37 °

C. to less than about 45 °

C.

8. The implantable shunt system of claim 1, wherein at least one of the one or more energy emitters is configured to deliver a pulsed thermal sterilizing stimulus of a character and for a duration sufficient to elevate a temperature of at least a portion of cells within a cerebrospinal fluid received within at least one of the one or more fluid-flow passageways from about 37 °

C. to less than about 42 °

C.

9. The implantable shunt system of claim 1, wherein at least one of the one or more energy emitters is configured to deliver a pulsed thermal sterilizing stimulus of a character and for a duration sufficient to elevate temperature of at least a portion of cells within a cerebrospinal fluid received within at least one of the one or more fluid-flow passageways from about a normal body temperature to a temperature ranging from greater than about 41 °

C. to less than about 63 °

C.

10. The implantable shunt system of claim 1, 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 programmed cell death without substantially inducing necrosis of an infectious agent within a cerebrospinal fluid proximate the surface of the body structure.

11. The implantable shunt system of claim 1, wherein at least one of the one or more energy emitters is configured to emit an energy stimulus of a character and for a time sufficient to induce apoptosis without substantially inducing necrosis of a pathogen within a cerebrospinal proximate the surface of the body structure.

12. The implantable shunt system of claim 1, wherein the body structure includes one or more cerebrospinal fluid shunts configured to drain cerebrospinal fluid from a region of a brain of the biological subject.

13. The implantable shunt system of claim 1, wherein the body structure includes one or more cannulas configured to drain a cerebrospinal fluid from a ventricle of a brain of the biological subject.

14. The implantable shunt system of claim 1, wherein the body structure includes a ventriculoperitoneal shunt.

15. The implantable shunt system of claim 1, wherein the index of refraction parameter is complex.

16. A method of inhibiting a microbial colonization in the cerebrospinal fluid of a biological subject, comprising:

selectively energizing one or more regions of at least one cerebrospinal fluid-flow passageway of an indwelling implant via one or more pulsed thermal stimuli emitting components in response to an automatically detected real time optical density parameter associated with a cerebrospinal fluid received within the at least one cerebrospinal fluid-flow passageway;

wherein the optical density parameter is indicative of a microbial colonization of the cerebrospinal fluid.

17. The method of claim 16, wherein selectively energizing includes concurrently or sequentially delivering at least a first pulsed thermal stimulus to a first region and a second pulsed thermal stimulus to a second region.

18. The method of claim 16, wherein selectively energizing includes concurrently or sequentially delivering at least a pulsed thermal stimulus to a first region and at least one of a pulsed electromagnetic stimulus, a pulsed electrical s stimulus, or a pulsed ultrasonic stimulus to a second region.

19. The method of claim 16, further comprising:

delivering an active agent composition to one or more regions of at least one fluid-flow passageway of an in vivo implanted cerebrospinal fluid management system in response to an automatically detected optical density parameter associated with a cerebrospinal fluid received within the at least one fluid-flow passageway.

20. A method, comprising:

providing a pulsed thermal sterilizing stimulus to an interior of at least one cerebrospinal fluid-flow passageway of an implanted device in response to a real-time detected change in a refractive index parameter indicative of a presence of an infectious agent within the at least one cerebrospinal fluid-flow passageway of the implanted device.

21. The method of claim 20, wherein providing the pulsed thermal sterilizing stimulus includes providing a spatially patterned pulsed thermal sterilizing stimulus having at least a first region and a second region different from the first region.

22. The method of claim 20, wherein providing the pulsed thermal sterilizing stimulus includes delivering 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 a spatial profile different from the first pulsed waveform segment.

23. The method of claim 20, wherein providing the pulsed thermal sterilizing stimulus includes providing a thermal pattern comprising at least a first region and a second region, the second region having at least one of an intensity, an energy-emitting pattern, a peak emission, an ON-pulse duration, an OFF-pulse duration, or a pulse frequency different from the first region.

24. The method of claim 20, wherein providing the pulsed thermal sterilizing stimulus includes providing a voltage to a cerebrospinal fluid received within the interior of at least one fluid-flow passageway, the voltage of sufficient strength or duration so as to cause a temperature elevation in region of a cerebrospinal fluid received within the at least one fluid-flow passageway from about a 37 °

C. to a temperature ranging from greater than about 41 °

C. to less than about 63 °

C.

25. The method of claim 20, further comprising:

providing a pulsed thermal sterilizing stimulus to a tissue proximate an outer surface of the implanted device.

26. The method of claim 25, wherein providing pulsed thermal sterilizing stimulus includes independently delivering, in vivo, at least one of a first pulsed thermal sterilizing stimulus to a cerebrospinal fluid received within the interior of at least one fluid-flow passageway and a second pulsed thermal sterilizing stimulus to a tissue proximate the outer surface of the implanted device.

27. A method, comprising:

providing a pulsed thermal sterilizing stimulus to an interior of at least one cerebrospinal fluid-flow passageway of an implanted device in response to a change in a refractive index parameter indicative of a presence of an infectious agent within the at least one cerebrospinal fluid-flow passageway of the implanted device; and

providing a pulsed thermal sterilizing stimulus to a tissue proximate an outer surface of the implanted device;

wherein providing pulsed thermal sterilizing stimulus includes independently delivering, in vivo, at least one of a first pulsed thermal sterilizing stimulus to a cerebrospinal fluid received within the interior of at least one fluid-flow passageway and a second pulsed thermal sterilizing stimulus to a tissue proximate the outer surface of the implanted cerebrospinal fluid management device in response to a real-time detected change in an index of refraction parameter associated with the cerebrospinal fluid received within the interior of at least one fluid-flow passageway.

28. A method, comprising:

delivering one or more pulsed thermal stimuli to at least one of an interior or an exterior of a cerebrospinal fluid-flow passageway of an indwelling implant apparatus in response to a real-time detected in vivo detected change in a refractive parameter indicative of a presence of an infectious agent proximate the exterior or the interior of the cerebrospinal fluid-flow passageway.

29. The method of claim 28, wherein delivering the one or more pulsed thermal stimuli includes delivering one or more pulsed thermal stimuli to at least one of an interior or an exterior of a cerebrospinal fluid-flow passageway of an indwelling cerebrospinal fluid management implant.