Lumenally-active device

• US 20070066929A1
• Filed: 04/12/2006
• Published: 03/22/2007
• Est. Priority Date: 04/19/2004
• Status: Active Grant

• Current Assignee: Gearbox LLC (Intellectual Ventures LLC)
• Original Assignee: Searete LLC (Intellectual Ventures LLC)
• Inventors: Ferren, Bran, Jung, Edward, Wilson, Richa, Hyde, Roderick, Sweeney, Elizabeth, Tegreene, Clarence, Myhrvold, Nathan, Wood, Lowell, Ishikawa, Muriel, Hillis, W., Wood, Victoria
• Granted Patent: US 9,011,329 B2
• Time in Patent Office: Days
• US Class Current: 604/8
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2010/0077 Cerebrospinal fluid
• CPC Class Codes: A61B 2010/0225 for taking multiple samples
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00345 Micromachines, nanomachines, microsystems
• CPC Class Codes: A61B 34/73 Manipulators for magnetic surgery
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• 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 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/418 lymph vessels, ducts or nodes
• CPC Class Codes: A61B 7/00 Instruments for auscultation
• CPC Class Codes: A61F 2/82 : Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61N 1/406 : using implantable thermoseeds or injected particles for localized hyperthermia preparations of seeds and particles A61K41/0052
• 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

Embodiments of a lumenally-active system and method of use and control thereof are disclosed. According to various embodiments, a lumenally-active device is positioned in a body lumen of an organism, where the device may sense a parameter of a fluid in the body lumen and perform an action on the fluid. Control logic and/or circuitry may be located on the device, or the system may include a separate control module. Liquid or gaseous fluids may be treated by embodiments of the device. Actions may include, for example, modification of a body fluid by addition or removal of a material, or by modification of a property of a body fluid or a component thereof.

Claims

1. A lumenally-active system, comprising:

a structural element configured to fit within at least a portion of a body lumen, the structural element including;

a lumen-wall-engaging portion;

and a fluid-contacting portion configured to contact fluid within the body lumen;

a sensor capable of detecting a condition of interest in the fluid;

response initiation circuitry operatively connected to the sensor and configured to generate a response initiation signal upon detection of the condition of interest in the fluid by the sensor; and

an active portion operatively connected to the response initiation circuitry and capable of producing a response upon receipt of the response initiation signal.

2. The system of claim 1, wherein the fluid includes a liquid.

14. The system of claim 1, wherein the fluid includes a gas or gaseous mixture.

18. The system of claim 1, wherein detecting a condition of interest in the fluid within the body lumen includes detecting the absence of a material of interest in the fluid within the body lumen.

19. The system of claim 18, including an active portion capable of adding the material of interest.

20. The system of claim 1, wherein detecting a condition of interest in the fluid within the body lumen includes detecting the presence of a material of interest in the fluid within the body lumen.

21. The system of claim 20, including an active portion capable of removing, modifying, or destroying at least a portion of the material of interest.

22. The system of claim 20, wherein the active portion includes a capture portion operatively coupled to the response initiation circuitry and configured to capture at least a portion of the detected material of interest.

26. The system of claim 1, wherein the body lumen is a lumen of a cardiovascular system of an organism.

27. The system of claim 26, wherein the body lumen is a lumen of a blood vessel of an organism.

139. The system of claim 2, wherein the liquid is at least one of lymph, cerebrospinal fluid, blood, urine, intestinal contents, esophageal contents, semen, mucous, saliva, tears, synthetic liquid, or introduced liquid.

140. The system of claim 14, wherein the gas or gaseous mixture is an inhaled gas or gaseous mixture, an expired gas or gaseous mixture, or an intestinal gas or gaseous mixture.

141. The system of claim 1, wherein the body lumen is at least a portion of a nostril, nasal cavity, respiratory tract, biliary tract, lymphatic system, urogenital tract, digestive tract, oral cavity, nervous system, tear duct, glandular system, or reproductive tract of an organism.

142. The system of claim 1, wherein the active portion includes at least one of a material release structure operatively coupled to the response initiation circuitry and configured to release a material in response to detection of the condition of interest, a heating element operatively coupled to the response initiation circuitry and configured to produce heating in response to detection of the condition of interest, a cooling element operatively coupled to the response initiation circuitry and configured to produce cooling in response to detection of the condition of interest, an electromagnetic radiation source operatively coupled to the response initiation circuitry and configured to emit electromagnetic radiation in response to detection of the condition of interest, an acoustic energy source operatively coupled to the response initiation circuitry and configured to emit acoustic energy in response to detection of the condition of interest, a pressure source operatively coupled to the response initiation circuitry and configured to apply pressure to the body lumen in response to detection of the condition of interest, a flow-modulating element operatively connected to the response initiation circuitry and configured to modulate the flow of fluid through at least a portion of the body lumen in response to detection of the condition of interest, a separator operatively connected to the response initiation circuitry and configured to selectively remove specific components from the fluid in response to detection of the condition of interest, a catalytic portion operatively connected to the response initiation circuitry and configured to expose a catalytic surface to the fluid in response to detection of the condition of interest, an electric field source operatively connected to the response initiation circuitry and configured to apply an electric field to the fluid in response to detection of the condition of interest, or a magnetic field source operatively connected to the response initiation circuitry and configured to apply a magnetic field to the fluid in response to detection of the condition of interest.

143. The system of claim 1, wherein the sensor is selected from an optical sensor, an imaging device, an acoustic sensor, a pressure sensor, a temperature sensor, a flow sensor, a viscosity sensor, a shear sensor, a chemical sensor, a biosensor, or an electrical sensor.

144. The system of claim 1, wherein the sensor is configured to measure at least one of the electrical resistivity of the fluid, the density of the fluid, the sound speed of the fluid, the pH of the fluid, the osmolality of the fluid, the index of refraction of the fluid at at least one wavelength, the optical absorption of the fluid, the optical emission of the fluid, the fluorescence of the fluid, or the phosphorescence of the fluid.

3-13. -13. (canceled)

15. (canceled)

16. (canceled)

17. (canceled)

23. (canceled)

24. (canceled)

25. (canceled)

28-77. -77. (canceled)

78. A method of treating a body fluid, comprising:

detecting a condition of interest in a fluid within a body lumen with a sensor portion of a lumenally-active system in the body lumen, the lumenally-active system also including a lumen-wall-engaging portion, a fluid-contacting portion configured to contact fluid within the body lumen, and an active portion capable of performing an action within the body lumen;

generating a response initiation signal with response initiation circuitry responsive to detection of the condition of interest in the fluid within the body lumen; and

performing an action within the body lumen with the active portion of the lumenally-active system in response to the response initiation signal.

106. The method of claim 78, wherein detecting a condition of interest in a body fluid in the body lumen includes detecting one of the presence or the absence of one or more substance, chemical compound, or chemical species in at least a portion of the body fluid in the body lumen.

107. The method of claim 106, wherein the one or more substance, chemical compound or chemical species includes at least one of a biological marker, an antibody, an antigen, a peptide, a polypeptide, a protein, a complex, a nucleic acid, a cell, a celular component or organele, a gamete, a pathogen, a lipid, a lipoprotein, an alcohol, an acid, an ion, an immunomodulator, a sterol, a carbohydrate, a polysaccharide, a glycoprotein, a metal, an electrolyte, a metabolite, an organic compound, an organophosphate, a drug, a therapeutic, a gas, a pollutant, or a tag.

119. The method of claim 78, wherein performing an action within the body lumen with the active portion of the lumenally-active device includes removing, modifying, destroying, or capturing at least a portion of the material of interest in at least a portion of the fluid.

145. The method of claim 78, wherein detecting a condition of interest in a body fluid includes processing a sense signal from the sensor portion of the lumenally-active system by at least one of filtering, signal amplification, windowing, noise reduction, clutter reduction, signal averaging, feature detection, time-domain analysis, frequency-domain analysis, spectral analysis, spectrophotometric analysis, feature extraction, comparison, sorting, reduction, or endpoint determination to determine the presence of the condition of interest.

146. The method of claim 78, wherein detecting a condition of interest in a body fluid in the body lumen includes detecting a temperature, pressure, fluid flow, fluid viscosity, shear modulus, optical absorption, optical emission, fluorescence, or phosphorescence, index of refraction at at least one wavelength, acoustic signal, electrical resistivity, density, sound speed, pH, or osmolality of the body fluid in the body lumen.

147. The method of claim 78, wherein detecting a condition of interest in a body fluid in the body lumen includes detecting the presence of at least one of an embolism, an object, a blood clot, a thrombus, an embolus, a plaque, a lipid, a lipoprotein, a kidney stone, a dust particle, a pollen particle, an aggregate, a cell, a specific type of cell, a celular component, a collection of cells, an organele, a gamete, a pathogen, or a parasite.

148. The method of claim 78, wherein performing an action within the body lumen with the active portion of the lumenally-active device includes at least one of activating a heating element, activating a cooling element, activating a material release portion, activating an electromagnetic radiation source, activating an acoustic energy source, activating a pressure-generating element, activating a flow-modulating element capable of modulating the flow of fluid through at least a portion of the body lumen, activating a separator capable of at least partly removing specific components from at least a portion of the fluid, activating a catalytic portion to expose a catalytic surface to at least a portion of the fluid, activating an electric field source to apply an electric field to at least a portion of the fluid, or activating a magnetic field source to apply a magnetic field to at least a portion of the fluid.

79-105. -105. (canceled)

108-118. -118. (canceled)

120. (canceled)

121. Software for operating a lumenally-active device, comprising:

a sensing module capable of receiving and processing a sense signal from a sensor portion of a lumenally-active system in a body lumen, the lumenally-active system also including a lumen-wall-engaging portion, a fluid-contacting portion configured to contact fluid within the body lumen, and an active portion capable of performing an action within the body lumen, and producing as output one or more sense parameters; and

a response initiation module capable of receiving as input the one or more sense parameters and generating as output a response initiation signal to cause the performance of an action within the body lumen with the active portion of the lumenally-active system.

122. The software of claim 121, wherein the sensing module is configured to receive the sense signal from the sensor portion substantially continuously.

123. The software of claim 121, wherein the sensing module includes software code for controlling polling of the sense signal from the sensor portion to detect the presence of a condition of interest in at least a portion of the body lumen.

124. The software of claim 121, wherein the sensing module includes interrupt-driven software code responsive to an interrupt signal from the sensor portion to begin receipt and processing of the sense signal.

125. The software of claim 121, wherein the sensing module is configured to process the sense signal to determine the presence or the absence of the condition of interest.

126. The software of claim 125, wherein the sensing module is configured to process the sense signal by at least one of filtering, signal amplification, windowing, noise reduction, clutter reduction, signal averaging, feature detection, time-domain analysis, frequency-domain analysis, feature extraction, comparison, sorting, reduction, and endpoint determination to determine the presence or the absence of the condition of interest.

127. The software of claim 121, wherein the sensing module is configured to detect a critical value in the sense signal, the critical value indicative of the presence or the absence of a condition of interest in at least a portion of the body lumen.

149. The software of claim 121, wherein the response initiation module is configured to perform at least one of calculating the response initiation signal based at least in part upon at least one of the one or more sense parameters;

generating the response initiation signal from a stored function;

or calculating the response initiation signal based at least in part upon at least one or more stored constants.

150. The software of claim 121, including a user interface module configured to receive user input of one or more user-enterable parameters from a user interface device, wherein the response initiation module is configured to generate the response initiation signal based at least in part upon one or more user-enterable parameters received from the user interface module.

128-138. -138. (canceled)