METHODS AND SYSTEMS FOR BLOCKING NEURAL ACTIVITY IN AN ORGAN OF A SUBJECT, PREFERABLY IN THE SMALL INTESTINE OR THE DUODENUM

• US 20170027645A1
• Filed: 04/16/2015
• Published: 02/02/2017
• Est. Priority Date: 04/17/2014
• Status: Active Grant

• Current Assignee: Digma Medical Ltd.
• Original Assignee: Digma Medical Ltd.
• Inventors: BEN OREN, Ilan, YANIV, Irit, WOLF, Tamir, HERSCHKOVITZ, Avia
• Granted Patent: US 10,537,387 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 1/012 characterised by internal passages or accessories therefor
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/22 the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
• CPC Class Codes: A61B 18/26 for producing a shock wave, e.g. laser lithotripsy
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00494 Stomach, intestines or bowel
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00589 Coagulation
• CPC Class Codes: A61B 2018/00601 Cutting
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00714 Temperature
• CPC Class Codes: A61B 2018/00744 Fluid flow
• CPC Class Codes: A61B 2018/00779 Power or energy
• CPC Class Codes: A61B 2018/00785 Reflected power
• CPC Class Codes: A61B 2018/00809 measured thermochromatically
• CPC Class Codes: A61B 2018/00904 Automatic detection of target tissue
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/0212 : using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/20355 : Special scanning path or conditions, e.g. spiral, raster or providing spot overlap
• CPC Class Codes: A61B 2018/20359 : by movable mirrors, e.g. galvanometric
• CPC Class Codes: A61B 2018/2261 : with scattering, diffusion or dispersion of light
• CPC Class Codes: A61B 2018/2266 : with a lens, e.g. ball tipped
• CPC Class Codes: A61B 2018/2277 : with refractive surfaces
• CPC Class Codes: A61B 2018/2283 : with pivotable mirrors
• CPC Class Codes: A61B 2090/061 : for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/3735 : Optical coherence tomography [OCT]
• CPC Class Codes: A61B 2090/378 : using ultrasound
• CPC Class Codes: A61B 2218/001 : having means for irrigation and/or aspiration of substances to and/or from the surgical site A61B2018/00029 and A61B2018/1472 take precedence
• CPC Class Codes: A61B 2505/05 : Surgical care
• CPC Class Codes: A61B 5/0066 : Optical coherence imaging
• CPC Class Codes: A61B 5/0086 : using infrared radiation
• CPC Class Codes: A61B 5/015 : By temperature mapping of body part
• CPC Class Codes: A61B 5/026 : Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/055 : involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/1076 : for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/4255 : Intestines, colon or appendix
• CPC Class Codes: A61B 6/00 : Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment instruments measuring radiation intensity for application in the field of nuclear medicine, e.g. in vivo counting, G01T1/161; apparatus for taking X-ray photographs G03B42/02
• CPC Class Codes: A61B 8/085 : for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 : Details of catheter construction
• CPC Class Codes: A61N 2005/063 : comprising light transmitting means, e.g. optical fibres
• CPC Class Codes: A61N 2005/0659 : infrared
• CPC Class Codes: A61N 2007/003 : Destruction of nerve tissue
• CPC Class Codes: A61N 2007/0043 : intra-cavitary
• CPC Class Codes: A61N 2007/0052 : using the same transducer for therapy and imaging
• CPC Class Codes: A61N 5/0603 : for treatment of body cavities
• CPC Class Codes: A61N 5/062 : Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61N 5/0625 : Warming the body, e.g. hyperthermia treatment
• 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

The present disclosure provides, according to some embodiments, methods and systems for selectively reducing, blocking or inhibiting at least part of the neural activity in an organ of a subject. In preferred embodiments, the method and system are used for selectively blocking at least part of the neural activity in a duodenum of a subject in need thereof. According to some embodiments, the selective blocking occurs through use of laser radiation. According to some embodiments, the selective blocking occurs through use of ultrasound energy. According to some embodiments, the selective blocking comprises causing damage to at least part of sensory nerves located within a target area while maintaining functional activity of tissue surrounding the sensory nerves by means of shielding it from the effects of laser radiation. According to some embodiments, the sensory nerves include neurons configured to transmit signals triggered by food passing through the duodenum, such as, but not limited to, neurohormonal signals.

Claims

1-111. -111. (canceled)

112. A method for reducing neural activity in an organ of a subject, the method comprising:

introducing at least one laser emitting device comprising a cooling mechanism into the organ;

emitting a laser beam from the laser emitting device to contact a target area on or beneath a wall of the organ and lowering a temperature of the organ using the cooling mechanism, thereby selectively damaging at least one sensory nerve located at the target area to at least partially reduce the neural activity while maintaining functional activity of tissue surrounding the neurons within the target area and/or surrounding the target area.

113. The method of claim 112, wherein the organ comprises a duodenum and the wall comprises a duodenal wall;

wherein the target area comprises at least part of an area selected from the group consisting of a Meissner'"'"'s plexus, an Auerbach'"'"'s plexus, a sub-mucosal layer of the duodenal wall, a tunica muscularis layer of the duodenal wall and a mesenteric layer interfacing with the duodenal wall.

114. The method of claim 113, wherein the at least one sensory nerve comprises at least one nerve that is activated by food passing through the duodenum;

and/or wherein said the at least one sensory nerve comprises at least one nerve that transmits signals from at least one of mechano-sensors or chemo-receptors located within the duodenal wall.

115. The method of claim 113, wherein the laser emitting device comprises a rotatable optical element configured to direct the laser beam to a plurality of target areas along a trajectory on or within the duodenal wall.

116. The method of claim 115, wherein the rotatable optical element is selected from a group consisting of a wide-angle lens, a dove prism, a reversion or “

K”

prism, a Delta or Pechan prism, a dispersive prism, a reflective prism, a beam-splitting prism, a deflective prism, a triangular prism, a trapezoidal prism, a Glan-Taylor prism or a Glan-laser prism, a high-powered laser-light right angle prism, a retroreflector and combinations thereof.

117. The method of claim 112, further comprising cooling or thermal shielding of tissue surrounding the at least one sensory nerve, wherein the cooling or thermal shielding of tissue surrounding the at least one sensory nerve comprises infusion, irrigation or rinsing of tissue surrounding the at least one sensory nerve with a coolant material.

118. The method of claim 112, wherein emitting the focused laser beam comprises emitting pulsed laser radiation.

119. The method of claim 112, wherein said subject is afflicted with a medical condition selected from the group consisting of obesity, type 2 diabetes, insulin resistance, metabolic syndrome, and combinations thereof.

120. A catheter for reducing neural activity in an organ of a subject, the catheter comprising:

an elongated catheter body having a proximal end and a distal end;

a laser emitting element coupled with the catheter body at or near the distal end wherein the laser emitting element comprises at least one optical fiber configured to emit a focused laser beam;

a cooling mechanism coupled with the catheter body, configured to lower a temperature of the organ; and

a rotatable optical element coupled with the laser emitting element and configured to direct the focused laser beam to one or more target areas on or beneath a wall of the organ, wherein the target area comprises at least one sensory nerve, such that the laser beam is configured to cause damage to the at least one sensory nerve;

wherein the catheter body has an outer diameter selected to fit through within a lumen of an endoscope.

121. The catheter of claim 120, wherein the rotatable optical element comprises a rotatable prism.

122. The catheter of claim 120, wherein the rotatable optical element is selected from a group consisting of a wide-angle lens, a dove prism, a reversion or “

K”

prism, a Delta or Pechan prism, a dispersive prism, a reflective prism, a beam-splitting prism, a deflective prism, a triangular prism, a trapezoidal prism, a Glan-Taylor prism or a Glan-laser prism, a high-powered laser-light right angle prism, a retroreflector and combinations thereof.

123. The catheter of claim 120, wherein the rotatable optical element deflects the laser beam at an angle of 90 degrees from a longitudinal axis of the catheter body, and/or wherein the rotatable optical element deflects the focused laser beam through an aperture in the catheter body.

124. The catheter of claim 120, wherein the rotatable optical element is located within a distal portion of the catheter body.

125. The catheter of claim 120, wherein the rotatable optical element comprises a beam-splitter prism that deflects the laser beam into a first beam of laser radiation that is focused on the target area and a second beam of laser radiation that is focused on a detector.

126. A system for reducing neural activity in at least one neural region in an organ of a subject, the system comprising:

a catheter comprising;

an elongated catheter body having a proximal end and a distal end;

a laser emitting element coupled with the catheter body at or near the distal end;

wherein the laser emitting element comprises at least one optical fiber configured to emit a focused laser beam;

a cooling mechanism coupled with the catheter body, configured to lower a temperature of the organ; and

a rotatable optical element coupled with the laser emitting element and configured to direct the focused laser beam to one or more target areas on or beneath a wall of the organ, wherein the target area comprises at least one sensory nerve, such that the laser beam is configured to cause damage to the at least one sensory nerve.

127. The system of claim 126, further comprising an imaging device configured to capture structural information related to the duodenal wall or an area in contact with at least part of the duodenal wall.

128. The system of claim 127, wherein the imaging device is selected from the group consisting of an optical imaging device, an endoscope, a thermal imaging device, an ultrasonic imaging device, a Near Infra-Red imaging device, an Infra-Red imaging device, an Optical Coherence Tomography (OCT) based imaging device and combinations thereof.

129. The system of claim 126, wherein the rotatable optical element comprises a rotatable prism.

130. The system of claim 126, wherein the rotatable optical element is selected from a group consisting of a wide-angle lens, a dove prism, a reversion or “

K”

prism, a Delta or Pechan prism, a dispersive prism, a reflective prism, a beam-splitting prism, a deflective prism, a triangular prism, a trapezoidal prism, a Glan-Taylor prism or a Glan-laser prism, a high-powered laser-light right angle prism, a retroreflector and combinations thereof.

131. The system of claim 126, further comprising at least one pressure-inducing element coupled with the catheter body and configured to exert pressure on at least part of the wall of the organ;

and/or to hold the laser emitting element in place;

wherein the pressure-inducing element further comprises laser transmissive cooling or thermal shielding material.