WO2018229771A1 - Spectroscopic clamper for real time nerve detection - Google Patents

Spectroscopic clamper for real time nerve detection Download PDF

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Publication number
WO2018229771A1
WO2018229771A1 PCT/IL2018/050656 IL2018050656W WO2018229771A1 WO 2018229771 A1 WO2018229771 A1 WO 2018229771A1 IL 2018050656 W IL2018050656 W IL 2018050656W WO 2018229771 A1 WO2018229771 A1 WO 2018229771A1
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WO
WIPO (PCT)
Prior art keywords
light
jaw
optical sensor
tissue
jaws
Prior art date
Application number
PCT/IL2018/050656
Other languages
French (fr)
Inventor
Meir Malul
Odelia SHIMSHON
Yaakov Nahmias
Amnon Buxboim
Yoav KAN-TOR
Yoav Mintz
Elchanan FRIED
David SHVEIKY
Original Assignee
Yissum Research Development Company Of The Hebrew University Of Jerusalem Ltd.
Hadasit Medical Research Services And Development Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Yissum Research Development Company Of The Hebrew University Of Jerusalem Ltd., Hadasit Medical Research Services And Development Ltd. filed Critical Yissum Research Development Company Of The Hebrew University Of Jerusalem Ltd.
Publication of WO2018229771A1 publication Critical patent/WO2018229771A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122Clamps or clips, e.g. for the umbilical cord
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0075Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4887Locating particular structures in or on the body
    • A61B5/4893Nerves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1442Probes having pivoting end effectors, e.g. forceps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • A61B2017/00057Light
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • A61B2017/2926Details of heads or jaws
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00595Cauterization
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00601Cutting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00779Power or energy
    • A61B2018/00785Reflected power
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00904Automatic detection of target tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00Ultrasound therapy

Definitions

  • the present disclosure generally relates to the field of devices and methods for real-time detection of nerves within live tissue, specifically spectroscopy based realtime detection of nerves during surgery.
  • Surgical procedures including laparoscopic and endoscopic studies and interventions, are prone to cause iatrogenic nerve damage, which in turn, may lead to loss of function, loss of sensation, muscle atrophy and/or chronic neuropathy in a patient. Often, such damage is caused inadvertently during surgery due to poor visibility of the nerves, within surrounding tissues. There is thus a need for efficient systems and methods for real time visualization of nerves during surgical procedures.
  • aspects of the disclosure relate to surgical tools such as graspers, clampers, cutters such as scalpels and the like, including sensors capable of detecting nerve in real-time.
  • a potential problem inflicted by a medical intervention is peripheral nerve damage.
  • the disclosed devices and methods may be used to distinguish a target tissue type, such as peripheral nerves, from other tissue types of a heterogeneous tissue, based on spectroscopic detection.
  • the detection may advantageously be done in real-time, while grasping the tissue to be cut and thus be utilized to guide the surgeon during the procedure.
  • the disclosed devices and methods advantageously enables detection of both afferent and efferent nerves. This is as opposed to nerve monitoring systems based on electromyography, which track electrical activity of muscle tissue in response to electric nerve stimulation, using electrodes attached to the skin or inserted into the muscle and are incapable of detecting afferent nerves, since these are not attached to muscles.
  • the herein disclosed devices and methods are advantageously suitable for utilization on endoscopic and laparoscopic tools.
  • a (surgical) clamping device comprising a pair of interfacing jaws connected (e.g., pivotally connected and/or connected by a spring) at a proximal end thereof (of the jaws), wherein the clamping device is configured to capture (grasp) a tissue between a first jaw of the jaws and a second jaw of the jaws; a light transmitter coupled to at least one of the first and the second jaws; and an optical sensor coupled to at least one of the first and the second jaw, wherein the light transmitter is configured to transmit light to the captured tissue, and the optical sensor is configured to sense light emitted from the captured tissue, wherein a wavelength of the transmitted light is configured for detection of a nerve in the captured tissue.
  • a processing circuitry functionally connected with the clamping device, the processing circuit configured to determine a presence of the nerve within the target tissue, based on a signal received from the optical sensor.
  • the light transmitter and the optical sensor are both coupled to the first jaw or to the second jaw, and the optical sensor is configured to sense light reflected from the captured tissue.
  • each of the light transmitter and the optical sensor is coupled to a different jaw of the first and the second jaws, and the optical sensor is configured to sense light transmitted through the captured tissue.
  • the captured tissue is within a body cavity of a subject.
  • the target tissue type is a nerve.
  • the wavelength of transmitted light is in the range of about 350-550 nanometers (nm), about 350-750 nm, or about 300-1000 nm. According to some embodiments, the wavelength of transmitted light is 405 nm. According to some embodiments, the wavelength of transmitted light is 488 nm. According to some embodiments, at least one of the first jaw and the second jaw includes or is associated with a cutter (such as but not limited to, a blade, an electrosurgical cutter, e.g., radio frequency cutter, laser cutter and the like).
  • a cutter such as but not limited to, a blade, an electrosurgical cutter, e.g., radio frequency cutter, laser cutter and the like.
  • both the first jaw and the second jaw include or are associated with a cutter (such as but not limited to, a blade, an electrosurgical, cutter, e.g., radio frequency cutter, laser cutter and the like).
  • a cutter such as but not limited to, a blade, an electrosurgical, cutter, e.g., radio frequency cutter, laser cutter and the like.
  • the light transmitter comprises a LED (light emitting diode). According to some embodiments, the light transmitter comprises a laser. According to some embodiments, the light transmitter comprises an optic fiber.
  • the optical sensor comprises a CCD, CMOS or a combination thereof.
  • the clamping device is configured for attachment to an endoscope and/or laparoscope. According to some embodiments, the clamping device is configured to be mounted on an endoscope and/or laparoscope. According to some embodiments, the clamping device is configured to be delivered through a working channel of an endoscope and/or laparoscope.
  • a method for detecting a target tissue type comprising: capturing a tissue between a first jaw and a second jaw of a pair of interfacing jaws connected (e.g., pivotally connected and/or connected by a spring) at a proximal end thereof; transmitting light from a light transmitter, coupled to at least one of the first and the second jaws, to the captured tissue, wherein a wavelength of the transmitted light is configured for detection of a target tissue type; and sensing light emitted by/from the captured tissue by an optical sensor coupled to at least one of the first and the second jaws; and determining a presence or absence of a nerve within the captured tissue based on the sensed light.
  • a target tissue type such as a presence of a nerve in a tissue
  • the jaws may be connected to each other or otherwise functionally associated with one another such that a motion of at least one jaw towards the other jaw is facilitated so as to allow grasping of tissue between the jaws.
  • one jaw may be stationary, and the other jaw may be movable or both jaws may be movable.
  • the capturing step is performed within a body of a subject during a surgical procedure.
  • the capturing step is performed within a body cavity of a subject.
  • the method further comprises the step of inserting a surgical device comprising the pair of interfacing jaws into a body of a subject. According to some embodiments, the method further comprises the step of inserting the pair of interfacing jaws into a body cavity.
  • the wavelength of transmitted light is in the range of about 350-550 nm, about 350-750 nm, or about 300-1000 nm. According to some embodiments, the wavelength of transmitted light is 405 nm. According to some embodiments, the wavelength of transmitted light is 488 nm.
  • the nerve is a nerve fiber having a diameter in the range of about 0.5-3 millimeters (mm), for example about 1-2 mm.
  • the method further comprises the step of providing an indication to the user if a nerve is present in the captured tissue.
  • At least one of the first jaw and the second jaw includes or is associated with a cutter (such as but not limited to, a blade, an electrosurgical cutter, e.g., radio frequency cutter, laser cutter and the like).
  • a cutter such as but not limited to, a blade, an electrosurgical cutter, e.g., radio frequency cutter, laser cutter and the like.
  • both the first jaw and the second jaw include or are associated with a cutter (such as but not limited to, a blade, an electrosurgical, cutter, e.g., radio frequency cutter, laser cutter and the like).
  • a cutter such as but not limited to, a blade, an electrosurgical, cutter, e.g., radio frequency cutter, laser cutter and the like.
  • the method further comprises the step of cutting the captured tissue if an absence of a nerve in the captured tissue is determined.
  • the method further comprises the step of refraining from cutting through the captured tissue if a presence of a nerve in the captured tissue is determined.
  • the light transmitter and the optical sensor are co-coupled (both coupled) to the first jaw or to the second jaw, and the optical sensor is configured to sense light reflected from the captured tissue.
  • each of the light transmitter and the optical sensor is coupled to a different jaw of the first and the second jaws, and the optical sensor is configured to sense light transmitted from/through the captured tissue.
  • the light transmitter comprises a LED (light emitting diode). According to some embodiments, the light transmitter comprises a laser. According to some embodiments, the light transmitter comprises an optic fiber.
  • the optical sensor comprises a CCD, CMOS or a combination thereof.
  • a surgical tool comprising: a cutter configured to cut and/or cauterize a target tissue; a light transmitter coupled to the cutter; and an optical sensor coupled to the cutter, wherein the light transmitter is configured to transmit light to the target tissue, when the cutter is juxtaposed the target tissue, wherein the optical sensor is configured to sense light emitted by/from the target tissue in response to the light transmitted thereon, wherein a wavelength of the transmitted light is configured for detection of a nerve within the target tissue.
  • the surgical tool further comprises a processing circuit functionally connected with the surgical tool, the processing circuit configured to determine a presence of the nerve within the target tissue, based on a signal received from the optical sensor.
  • the surgical tool comprises a pair of interfacing jaws connected (e.g., pivotally connected and/or connected by a spring) at a proximal end thereof, wherein the pair of interfacing jaws is configured to capture the tissue between a first jaw of the jaws and a secondjaw of the jaws.
  • the light transmitter is coupled to at least one of the first and the second jaws and the optical sensor is coupled to at least one of the first and the secondjaw.
  • the light transmitter and the optical sensor are co-coupled to the first jaw or to the second jaw, and the optical sensor is configured to sense light reflected from the captured tissue.
  • each of the light transmitter and the optical sensor is coupled to a different jaw of the first and the second jaws, and the optical sensor is configured to sense light transmitted through the captured tissue.
  • the wavelength of transmitted light is in the range of about 350-550 nm, about 350-750 nm, or about 300-1000 nm. According to some embodiments, the wavelength of transmitted light is 405 nm. According to some embodiments, the wavelength of transmitted light is 488 nm.
  • the cutter comprises an ultrasonic transducer configured to cut and/or cauterize the target tissue via vibration.
  • the vibration is in the range of 20,000Hz to 60,000Hz.
  • the cutter comprises a surgical blade.
  • the cutter comprises an electrosurgical cutter, such as radio frequency (RF) cutter, configured to cut and/or cauterize the target tissue by providing an electrical current thereto.
  • the cutter comprises a radiation based cutter, such as a laser cutter.
  • the light transmitter comprises a LED (light emitting diode). According to some embodiments, the light transmitter comprises a laser. According to some embodiments, the light transmitter comprises an optic fiber.
  • the optical sensor comprises a CCD, CMOS or a combination thereof.
  • the surgical tool is configured for attachment to an endoscope and/or laparoscope.
  • Certain embodiments of the present disclosure may include some, all, or none of the above advantages.
  • One or more technical advantages may be readily apparent to those skilled in the art from the figures, descriptions and claims included herein.
  • specific advantages have been enumerated above, various embodiments may include all, some or none of the enumerated advantages.
  • FIGS. 1A and IB are block diagrams of a clamping device having a light transmitter and a light sensor in a closed and an open configuration, respectively, according to some embodiments;
  • Figs. 2A and 2B are block diagrams of a clamping device having a light transmitter and a light sensor in a closed and an open configuration, respectively, according to other embodiments;
  • Figs. 3A and 3B are a front and a side view of a laparoscopic clamp, respectively, according to some embodiments.
  • Fig. 4 is a flow chart of the steps of a method for detecting a presence of a target tissue type (e.g., a nerve) within a tissue, according to some embodiments;
  • a target tissue type e.g., a nerve
  • Figs. 5A-H are microscopic images of blood vessels (Figs. 5A and 5B), a fat tissue extracted from the omentum of a pig (Figs. 5C and 5D), an obturator nerve of a pig (Figs. 5E and 5F), a rectus abdominis muscle tissue and an intercostal nerve, which is indicated by an arrow (Figs. 5G and 5H) imaged under white light (Figs. 5A, 5C, 5E, and 5G) or with a wavelength of 488 nm (Figs. 5B, 5D, 5F, and 5H); and
  • Figs. 6A-C are microscopic images of a nerve surrounded by muscle tissues imaged with white light (Fig. 6A), a wavelength of 405 nm (Fig. 6B), and a wavelength of 488 nm (Fig. 6C).
  • the disclosed devices and methods are used for capturing and/or imaging a heterogeneous tissue, such as during an interventional medical procedure (e.g., laparoscopy, endoscopy, surgery, etc.), detecting a target tissue type within the heterogenous tissue and to distinguish it therefrom.
  • the captured and/or imaged heterogeneous tissue is in a body cavity of a subject undergoing an interventional medical procedure.
  • the interventional medical procedure is minimally invasive procedure such as but not limited to laparoscopy and endoscopy.
  • the captured and/or imaged heterogeneous tissue is extracted from a subject's body.
  • a nerve fiber within a heterogeneous tissue is detected and distinguished from surrounding tissue types such as muscle tissue, fat, bone tissue and/or blood vessels, within the heterogeneous tissue.
  • the detected target tissue type is a nerve fiber.
  • the nerve fiber has a diameter of at least 0.5 mm, at least 0.75 mm or at least 1mm. Each possibility represents a separate embodiment.
  • the nerve fiber has a diameter in the range of 0.5 mm to 3 mm, 0.5 mm to 4 mm, 0.5 mm to 5 mm, 1 mm to 3 mm, 1 mm to 4 mm, or 1 mm to 5 mm.
  • a myelin sheath of a nerve's axon is detected.
  • subject and patient may be used interchangeably herein to refer to an animal, more particularly to non-human mammals and humans including prenatal forms of animals, such as, e.g., embryos or fetuses.
  • non-human animals include: horse, cow, camel, goat, sheep, dog, cat, non-human primate, mouse, rat, rabbit, hamster, guinea pig, pig.
  • the subject is a subject undergoing interventional medical procedure (e.g., laparoscopy, endoscopy, surgery, etc.).
  • a surgical tool including a light transmitter and an optical sensor coupled thereto.
  • the surgical tool is configured for attachment to an endoscope and/or laparoscope.
  • surgical tool may refer to any tool configured to be used during an interventional medical procedure.
  • surgical tool encompasses any tool configured to capture, grasp, cut coagulate, desiccate, fulgurate, seal, ultrasize and/or cauterize a target tissue. Each possibility is a separate embodiment.
  • Non-limiting options of suitable surgical tools include surgical blades, electrosurgical cutters, laser cutters, high-frequency ultrasound cutters, radiofrequency cutters etc., and combinations thereof. Each possibility is a separate embodiment.
  • the term "light transmitter” may refer to any light source configured to transmit light having a wavelength selectively absorbed or reflected by nerves or otherwise enabling their selective detection and differentiation from surrounding tissues, such as but not limited to muscle tissue, fat, bone tissue and/or blood vessels. Each possibility is a separate embodiment.
  • suitable light transmitters include a LED (light emitting diode), a laser, and an optic fiber.
  • the term "optical sensor” may refer to any light detector configured to sense light emitted by nerves in the target tissue in response to the light transmitted thereon.
  • the optical sensor may be a digital camera configured to image the tissue.
  • the optical sensor may include a charge-coupled device (CCD), a complementary metal- oxide semiconductor (CMOS) or a combination thereof.
  • CCD charge-coupled device
  • CMOS complementary metal- oxide semiconductor
  • the surgical tool may further include a processing circuit functionally connected to the surgical tool.
  • the processing circuit may be an integral part of the surgical tool.
  • the processing circuit may be external yet functionally connected to the surgical tool, for example through a signal transmitter.
  • the processing circuit may be configured to determine a presence (or absence) of the nerve within the target tissue, based on a signal indicative of the emitted light, obtained from the optical sensor.
  • the processing circuit may be configured to indicate a position of a nerve within the heterogenous tissue by performing an image analysis on the obtained image.
  • the image analysis may include image segmentation.
  • segmentation may refer to the process of subdividing a digital image into multiple segments (set of pixels) having similar attributes.
  • the segmentation may be based on discontinuity, i.e. portioning of the image based on identified abrupt changes.
  • the segmentation may be based on similarity, i.e. portioning of the image based on similar regions according to predefined criteria, such as thresholding, region growing, region splitting and merging, etc.
  • predefined criteria such as thresholding, region growing, region splitting and merging, etc.
  • the segmentation may be performed in a horizontal, vertical and/or diagonal direction.
  • the surgical tool includes a cutter configured to cut and/or cauterize a target tissue.
  • the light transmitter and the optical sensor may be coupled to the cutter.
  • the optical sensor may be configured to sense light reflected from the captured tissue.
  • the cutter may include a surgical blade.
  • the cutter may include an electrosurgical cutter configured to cut and/or cauterize the target tissue by providing an electrical current thereto.
  • the cutter may include an ultrasonic transducer configured to cut and/or cauterize the target tissue via vibration.
  • the vibration is in the range of 20,000 Hz to 60,000 Hz.
  • the cutter may be an ultrasonically generated frictional heat energy and electrically generated bipolar energy provider, such as but not limited to Thunderbeat surgical tissue management system (Olympus).
  • the cutter may provide high current and low voltage (lower than the 180 V used in conventional electro-surgery), optionally in combination with a high coaptive pressure, such as but not limited to LigaSure vessel sealing system (Covidien).
  • the cutter may be an ultrasound (US) transducer configured to cut tissue by ultracision, such as but not limited to Harmonic scalpel (Ethicon).
  • the surgical tool may be a clamping device.
  • clamping device and “graspers” may be used interchangeably and may refer to any device shaped with two interfacing jaws configured to capture and/or grasp tissue from both sides thereof.
  • the term “clamping device” may further encompass clamping instruments configured to capture and modify/effect a tissue such as staplers, electronic vessel sealers, cutters and the like.
  • the clamping device may include a pair of interfacing jaws connected (e.g., pivotally connected) at a proximal end thereof, wherein the pair of interfacing jaws is configured to capture/grasp/clamp the tissue there between.
  • the interfacing jaws may be operable between an open configuration/state wherein a first jaw of the jaws is spaced from a second jaw of the jaws to accept a tissue, and a closed configuration/state wherein the jaws are proximate to at least partially capture the tissue between them.
  • a cutter may be positioned on or may be an integral part of the clamping device, i.e., positioned on or integrally formed with its jaws.
  • Each of the light transmitter and the optical sensor may be coupled to at least one jaw of the first and the second jaws.
  • the light transmitter and the optical sensor are co-coupled to the first jaw or to the second jaw.
  • the optical sensor may be configured to sense light reflected from the captured tissue.
  • each one of the light transmitter and the optical sensor is coupled to a different jaw of the first and the second jaws.
  • the optical sensor may be configured to sense light transmitted from and/or through the captured tissue.
  • the wavelength of transmitted light is in the range of 300-1000 nm, 350-550 nm, 380-520 nm, 400-500 nm, or 400-490 nm. Each possibility represents a separate embodiment.
  • the wavelength of transmitted light is 405 nm. According to some embodiments, the wavelength of transmitted light is 488 nm. As exemplified in the experimental examples below, a wavelength of transmitted light in the range of 400-500 nm (e.g., 405 nm, and 488 nm) may be used to distinguish nerves having a diameter in the range of 0.5 mm - 3 mm from other tissue types of a heterogeneous tissue such as muscle tissue, fat, bone tissue and blood vessels, in real time.
  • a wavelength of transmitted light in the range of 400-500 nm e.g., 405 nm, and 488 nm
  • a wavelength of transmitted light in the range of 400-500 nm may be used to distinguish nerves having a diameter in the range of 0.5 mm - 3 mm from other tissue types of a heterogeneous tissue such as muscle tissue, fat, bone tissue and blood vessels, in real time.
  • a pair of jaws of Fig. 1 is referenced by the number 102
  • a pair of jaws of Fig. 2, which corresponds to pair of jaws 102 of Fig. 1, is referenced by the number 202.
  • FIGS. 1A and IB show a clamping device 100 that may be used to grasp a tissue and detect a target tissue type to distinguish it from surrounding tissue types of the grasped tissue, in accordance with an embodiment.
  • a longitudinal axis is indicated in Fig. 1A.
  • the axis labelled 'longitudinal axis' refers to a central axis that runs along a length of device 100, from a proximal end 104 to a distal end 106.
  • Clamping device 100 includes a pair of interfacing jaws 102 pivotally connected at proximal end 104 and configured to capture a tissue (not shown) between a first jaw 102a and a second jaw 102b of interfacing jaws 102; a light transmitter 108 coupled to at least one of interfacing jaws 102 and configured to transmit light to the captured tissue, wherein a wavelength of the transmitted light is configured for detection of a target tissue type; and an optical sensor 110 coupled to at least one of interfacing jaws 102 and configured to sense light emitted by the captured tissue.
  • clamping device 100 communicates with a processing circuit (not shown) configured to determine a presence of the target tissue type (e.g., nerve) within the captured tissue based on the emitted light, obtained from optical sensor 110.
  • a processing circuit not shown
  • determine a presence of the target tissue type e.g., nerve
  • light transmitter 108 and optical sensor 110 are co-coupled to one jaw and optical sensor 110 is configured to sense light reflected from the captured tissue.
  • light transmitter 108 and optical sensor 110 are co-coupled to first jaw 102a.
  • light transmitter 108 and optical sensor 110 are co-coupled to first jaw 102a or to second jaw 102b.
  • FIGs. 2 A and 2B show a clamping device 200 that may be used to grasp a tissue and detect and/or distinguish a target tissue type from the surrounding tissue grasped by clamping device 200, in accordance with an embodiment.
  • Clamping device 200 is substantially similar to clamping device 100 described in Figs. 1A-B with the notable difference that each of a light transmitter 208 and an optical sensor 210 of clamping device 200 is coupled to a different jaw of interfacing jaws 202 of clamping device 200, and optical sensor 210 is configured to sense light transmitted from and/or through the captured tissue. As shown in Figs.
  • light transmitter 208 may be coupled to a first jaw 202a of interfacing jaws 202 and optical sensor 210 may be coupled to second jaw 202b of interfacing jaws 202.
  • light transmitter 208 is coupled to second jaw 202b and optical sensor 210 is coupled to first jaw 202a.
  • Figs. 3 A and 3B show a laparoscopic clamp 300 that may be used to capture a tissue in a body cavity and detect a target tissue type within the captured tissue, in accordance with an embodiment.
  • Laparoscopic clamp 300 is substantially similar to clamping device 200 described in Figs. 2A-B with the notable difference that laparoscopic clamp 300 is adapted to be inserted into a body cavity, such as, in a non-limiting example, through a working channel of a laparoscope which may extend through a body wall into the body cavity.
  • laparoscopic clamp 300 includes a pair of interfacing jaws 302 pivotally connected at their proximal end 304 to cylindrical elongated body 303 and configured to capture a tissue (not shown) between a first jaw 302a and a second jaw 302b of interfacing jaws 302; a light transmitter 308 and a light emitter 310, wherein light transmitter 308 is coupled to first jaw 302a and a light emitter 310 is coupled to second jaw 302b.
  • Laparoscopic clamp 300 may be sized and designed according to a desired laparoscopic procedure.
  • a length of jaws 302 of laparoscopic clamp 300 as measured from a proximal end 304 to a distal end 306 ranges from 20 mm to 80 mm, 20 mm to 60 mm, 20 mm to 40 mm, 20 mm to 80 mm, 20 mm to 60 mm, 20 mm to 40 mm, 30 mm to 80 mm, 30 mm to 60 mm, or 30 mm to 40 mm.
  • a cross sectional diameter of jaws 302 measured at distal end 306 may range from 2 mm-8 mm in a closed configuration/state to 5 mm to 12 mm in an open configuration.
  • a length of laparoscopic clamp 300 as measured from a proximal end 304a of cylindrical elongated body 303 to a distal end 306 of jaws 302b is about 30 mm.
  • a cross sectional diameter of laparoscopic clamp 300, in its closed configuration/state, is substantially constant throughout its length and ranges from 1.5 mm to 3 mm.
  • the cross-sectional diameter of laparoscopic clamp 300 in its open configuration/state increases gradually from proximal end 304 to distal end 306, and ranges from 5 mm to 6 mm at distal end 306.
  • a tissue is captured between a first jaw and a second jaw of a pair of jaws (step 420).
  • the tissue is captured within a body cavity of a subject.
  • the pair of jaws are inserted into a body during surgery.
  • Light having a wavelength configured for detection of a target tissue type, is transmitted from a light transmitter coupled to at least one of the first and second jaws to the captured tissue (step 422).
  • the wavelength of transmitted light is in the range of 350-550.
  • the target tissue type is a nerve.
  • the nerve may be a nerve fiber having a diameter in the range of 0.5-3 mm.
  • Light emitted by the captured tissue is sensed by an optical sensor coupled to at least one of the first and second jaws (step 424).
  • a presence of the target tissue type within the captured tissue is determined based on emitted light is determined.
  • an indication to the user is provided if the target tissue type (e.g., a nerve) is present in the captured tissue.
  • steps 420, 422, and 424 may be performed simultaneously and/or sequentially. Additionally or alternatively, each of steps 420, 422, and 424 may be initiated in an interchangeable order.
  • samples of different tissue types were obtained from a pig, each sample had a thickness of 2-3 mm and was 2-3 mm in length and width.
  • the obtained samples included blood vessels, fat tissue extracted from a pig's omentum, obturator nerve, and rectus abdominis muscle and an neuromuscular junction and/or exon in neuromuscular junction.
  • the extracted samples were imaged with white light, or a wavelength of 488 nm.
  • Figs. 5A-5H As demonstrated in Figs. 5A-5H when the samples were imaged with a wavelength of 488 nm, only the nerve was visible. Further, the neuromuscular junction was distinguished from the surrounding rectus abdominis when imaged with a wavelength of 488 nm (Fig. 5H).
  • a heterogeneous tissue sample having a nerve surrounded by muscle tissue was imaged with white light, a wavelength of 405 nm, or a wavelength of 488 nm.
  • the nerve was not distinguishable from the muscle tissue (Fig. 6A).
  • the heterogeneous tissue was imaged with a wavelength of 405 nm (Fig. 6B) or 488 nm (Fig. 6B) only the nerve was visible and not the muscle tissue.
  • Embodiments of the present invention may include apparatuses for performing the operations herein.
  • This apparatus may be specially constructed for the desired purposes, or it may comprise a general-purpose computer selectively activated or reconfigured by a computer program stored in the computer.
  • a computer program may be stored in a computer readable storage medium, such as, but not limited to, any type of disk including floppy disks, optical disks, CD-ROMs, magnetic-optical disks, read-only memories (ROMs), random access memories (RAMs), electrically programmable read-only memories (EPROMs), electrically erasable and programmable read only memories (EEPROMs), magnetic or optical cards, or any other type of media suitable for storing electronic instructions, and capable of being coupled to a computer system bus.
  • the invention may be described in the general context of computer-executable instructions, such as program modules, being executed by a computer.
  • program modules include routines, programs, objects, components, data structures, and so forth, which perform particular tasks or implement particular abstract data types.
  • the invention may also be practiced in distributed computing environments where tasks are performed by remote processing devices that are linked through a communications network.
  • program modules may be located in both local and remote computer storage media including memory storage devices.

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Abstract

Disclosed herein are clamping devices and methods for using the same. The clamping device comprises: a pair of interfacing jaws pivotally connected at a proximal end thereof, wherein said clamping device is configured to capture a tissue between a first jaw of said jaws and a second jaw of said jaws; a light transmitter coupled to at least one of said first and said second jaws; and an optical sensor coupled to at least one of said first and the second jaw, wherein the light transmitter is configured to transmit light to the captured tissue, and the optical sensor is configured to sense light emitted by the captured tissue, wherein a wavelength of the transmitted light is configured for detection of a target tissue type.

Description

SPECTROSCOPIC CLAMPER FOR REAL TIME NERVE DETECTION
TECHNICAL FIELD
The present disclosure generally relates to the field of devices and methods for real-time detection of nerves within live tissue, specifically spectroscopy based realtime detection of nerves during surgery.
BACKGROUND
Surgical procedures, including laparoscopic and endoscopic studies and interventions, are prone to cause iatrogenic nerve damage, which in turn, may lead to loss of function, loss of sensation, muscle atrophy and/or chronic neuropathy in a patient. Often, such damage is caused inadvertently during surgery due to poor visibility of the nerves, within surrounding tissues. There is thus a need for efficient systems and methods for real time visualization of nerves during surgical procedures.
SUMMARY
Aspects of the disclosure, in some embodiments thereof, relate to surgical tools such as graspers, clampers, cutters such as scalpels and the like, including sensors capable of detecting nerve in real-time.
A potential problem inflicted by a medical intervention, such as open surgery, laparoscopy, and endoscopy, is peripheral nerve damage.
Advantageously, the disclosed devices and methods may be used to distinguish a target tissue type, such as peripheral nerves, from other tissue types of a heterogeneous tissue, based on spectroscopic detection. The detection may advantageously be done in real-time, while grasping the tissue to be cut and thus be utilized to guide the surgeon during the procedure.
As a further advantage, the disclosed devices and methods advantageously enables detection of both afferent and efferent nerves. This is as opposed to nerve monitoring systems based on electromyography, which track electrical activity of muscle tissue in response to electric nerve stimulation, using electrodes attached to the skin or inserted into the muscle and are incapable of detecting afferent nerves, since these are not attached to muscles.
In addition, the herein disclosed devices and methods are advantageously suitable for utilization on endoscopic and laparoscopic tools.
According to some aspects, there is provided a (surgical) clamping device, the device comprising a pair of interfacing jaws connected (e.g., pivotally connected and/or connected by a spring) at a proximal end thereof (of the jaws), wherein the clamping device is configured to capture (grasp) a tissue between a first jaw of the jaws and a second jaw of the jaws; a light transmitter coupled to at least one of the first and the second jaws; and an optical sensor coupled to at least one of the first and the second jaw, wherein the light transmitter is configured to transmit light to the captured tissue, and the optical sensor is configured to sense light emitted from the captured tissue, wherein a wavelength of the transmitted light is configured for detection of a nerve in the captured tissue.
According to some embodiments, there is further provided a processing circuitry functionally connected with the clamping device, the processing circuit configured to determine a presence of the nerve within the target tissue, based on a signal received from the optical sensor.
According to some embodiments, the light transmitter and the optical sensor are both coupled to the first jaw or to the second jaw, and the optical sensor is configured to sense light reflected from the captured tissue.
According to some embodiments, each of the light transmitter and the optical sensor is coupled to a different jaw of the first and the second jaws, and the optical sensor is configured to sense light transmitted through the captured tissue.
According to some embodiments, the captured tissue is within a body cavity of a subject.
According to some embodiments, the target tissue type is a nerve.
According to some embodiments, the wavelength of transmitted light is in the range of about 350-550 nanometers (nm), about 350-750 nm, or about 300-1000 nm. According to some embodiments, the wavelength of transmitted light is 405 nm. According to some embodiments, the wavelength of transmitted light is 488 nm. According to some embodiments, at least one of the first jaw and the second jaw includes or is associated with a cutter (such as but not limited to, a blade, an electrosurgical cutter, e.g., radio frequency cutter, laser cutter and the like).
According to some embodiments, both the first jaw and the second jaw include or are associated with a cutter (such as but not limited to, a blade, an electrosurgical, cutter, e.g., radio frequency cutter, laser cutter and the like).
According to some embodiments, the light transmitter comprises a LED (light emitting diode). According to some embodiments, the light transmitter comprises a laser. According to some embodiments, the light transmitter comprises an optic fiber.
According to some embodiments, the optical sensor comprises a CCD, CMOS or a combination thereof.
According to some embodiments, the clamping device is configured for attachment to an endoscope and/or laparoscope. According to some embodiments, the clamping device is configured to be mounted on an endoscope and/or laparoscope. According to some embodiments, the clamping device is configured to be delivered through a working channel of an endoscope and/or laparoscope.
According to some aspects, there is provided a method for detecting a target tissue type (such as a presence of a nerve in a tissue), the method comprising: capturing a tissue between a first jaw and a second jaw of a pair of interfacing jaws connected (e.g., pivotally connected and/or connected by a spring) at a proximal end thereof; transmitting light from a light transmitter, coupled to at least one of the first and the second jaws, to the captured tissue, wherein a wavelength of the transmitted light is configured for detection of a target tissue type; and sensing light emitted by/from the captured tissue by an optical sensor coupled to at least one of the first and the second jaws; and determining a presence or absence of a nerve within the captured tissue based on the sensed light.
According to some embodiments, the jaws may be connected to each other or otherwise functionally associated with one another such that a motion of at least one jaw towards the other jaw is facilitated so as to allow grasping of tissue between the jaws. For example, one jaw may be stationary, and the other jaw may be movable or both jaws may be movable. According to some embodiments, the capturing step is performed within a body of a subject during a surgical procedure. According to some embodiments, the capturing step is performed within a body cavity of a subject.
According to some embodiments, the method further comprises the step of inserting a surgical device comprising the pair of interfacing jaws into a body of a subject. According to some embodiments, the method further comprises the step of inserting the pair of interfacing jaws into a body cavity.
According to some embodiments, the wavelength of transmitted light is in the range of about 350-550 nm, about 350-750 nm, or about 300-1000 nm. According to some embodiments, the wavelength of transmitted light is 405 nm. According to some embodiments, the wavelength of transmitted light is 488 nm.
According to some embodiments, the nerve is a nerve fiber having a diameter in the range of about 0.5-3 millimeters (mm), for example about 1-2 mm.
According to some embodiments, the method further comprises the step of providing an indication to the user if a nerve is present in the captured tissue.
According to some embodiments, at least one of the first jaw and the second jaw includes or is associated with a cutter (such as but not limited to, a blade, an electrosurgical cutter, e.g., radio frequency cutter, laser cutter and the like).
According to some embodiments, both the first jaw and the second jaw include or are associated with a cutter (such as but not limited to, a blade, an electrosurgical, cutter, e.g., radio frequency cutter, laser cutter and the like).
According to some embodiments, the method further comprises the step of cutting the captured tissue if an absence of a nerve in the captured tissue is determined.
According to some embodiments, the method further comprises the step of refraining from cutting through the captured tissue if a presence of a nerve in the captured tissue is determined.
According to some embodiments, the light transmitter and the optical sensor are co-coupled (both coupled) to the first jaw or to the second jaw, and the optical sensor is configured to sense light reflected from the captured tissue. According to some embodiments, each of the light transmitter and the optical sensor is coupled to a different jaw of the first and the second jaws, and the optical sensor is configured to sense light transmitted from/through the captured tissue.
According to some embodiments, the light transmitter comprises a LED (light emitting diode). According to some embodiments, the light transmitter comprises a laser. According to some embodiments, the light transmitter comprises an optic fiber.
According to some embodiments, the optical sensor comprises a CCD, CMOS or a combination thereof.
According to some aspects, there is provided a surgical tool comprising: a cutter configured to cut and/or cauterize a target tissue; a light transmitter coupled to the cutter; and an optical sensor coupled to the cutter, wherein the light transmitter is configured to transmit light to the target tissue, when the cutter is juxtaposed the target tissue, wherein the optical sensor is configured to sense light emitted by/from the target tissue in response to the light transmitted thereon, wherein a wavelength of the transmitted light is configured for detection of a nerve within the target tissue.
According to some embodiments, the surgical tool further comprises a processing circuit functionally connected with the surgical tool, the processing circuit configured to determine a presence of the nerve within the target tissue, based on a signal received from the optical sensor.
According to some embodiments, the surgical tool comprises a pair of interfacing jaws connected (e.g., pivotally connected and/or connected by a spring) at a proximal end thereof, wherein the pair of interfacing jaws is configured to capture the tissue between a first jaw of the jaws and a secondjaw of the jaws.
According to some embodiments, the light transmitter is coupled to at least one of the first and the second jaws and the optical sensor is coupled to at least one of the first and the secondjaw. According to some embodiments, the light transmitter and the optical sensor are co-coupled to the first jaw or to the second jaw, and the optical sensor is configured to sense light reflected from the captured tissue. According to some embodiments, each of the light transmitter and the optical sensor is coupled to a different jaw of the first and the second jaws, and the optical sensor is configured to sense light transmitted through the captured tissue.
According to some embodiments, the wavelength of transmitted light is in the range of about 350-550 nm, about 350-750 nm, or about 300-1000 nm. According to some embodiments, the wavelength of transmitted light is 405 nm. According to some embodiments, the wavelength of transmitted light is 488 nm.
According to some embodiments, the cutter comprises an ultrasonic transducer configured to cut and/or cauterize the target tissue via vibration. According to some embodiments, the vibration is in the range of 20,000Hz to 60,000Hz. According to some embodiments, the cutter comprises a surgical blade. According to some embodiments, the cutter comprises an electrosurgical cutter, such as radio frequency (RF) cutter, configured to cut and/or cauterize the target tissue by providing an electrical current thereto. According to some embodiments, the cutter comprises a radiation based cutter, such as a laser cutter.
According to some embodiments, the light transmitter comprises a LED (light emitting diode). According to some embodiments, the light transmitter comprises a laser. According to some embodiments, the light transmitter comprises an optic fiber.
According to some embodiments, the optical sensor comprises a CCD, CMOS or a combination thereof.
According to some embodiments, the surgical tool is configured for attachment to an endoscope and/or laparoscope.
Certain embodiments of the present disclosure may include some, all, or none of the above advantages. One or more technical advantages may be readily apparent to those skilled in the art from the figures, descriptions and claims included herein. Moreover, while specific advantages have been enumerated above, various embodiments may include all, some or none of the enumerated advantages.
BRIEF DESCRIPTION OF THE DRAWINGS
Some embodiments of the disclosure are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some embodiments of the disclosure may be practiced. The figures are for the purpose of illustrative discussion and no attempt is made to show structural details of an embodiment in more detail than is necessary for a fundamental understanding of the teachings of the disclosure. For the sake of clarity, some objects depicted in the figures are not to scale. Figs. 1A and IB are block diagrams of a clamping device having a light transmitter and a light sensor in a closed and an open configuration, respectively, according to some embodiments;
Figs. 2A and 2B are block diagrams of a clamping device having a light transmitter and a light sensor in a closed and an open configuration, respectively, according to other embodiments;
Figs. 3A and 3B are a front and a side view of a laparoscopic clamp, respectively, according to some embodiments; and
Fig. 4 is a flow chart of the steps of a method for detecting a presence of a target tissue type (e.g., a nerve) within a tissue, according to some embodiments;
Figs. 5A-H are microscopic images of blood vessels (Figs. 5A and 5B), a fat tissue extracted from the omentum of a pig (Figs. 5C and 5D), an obturator nerve of a pig (Figs. 5E and 5F), a rectus abdominis muscle tissue and an intercostal nerve, which is indicated by an arrow (Figs. 5G and 5H) imaged under white light (Figs. 5A, 5C, 5E, and 5G) or with a wavelength of 488 nm (Figs. 5B, 5D, 5F, and 5H); and
Figs. 6A-C are microscopic images of a nerve surrounded by muscle tissues imaged with white light (Fig. 6A), a wavelength of 405 nm (Fig. 6B), and a wavelength of 488 nm (Fig. 6C).
DETAILED DESCRIPTION
In the following description, various aspects of the disclosure will be described. For the purpose of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the different aspects of the disclosure. However, it will also be apparent to one skilled in the art that the disclosure may be practiced without specific details being presented herein. Furthermore, well-known features may be omitted or simplified in order not to obscure the disclosure.
Advantageously, the disclosed devices and methods are used for capturing and/or imaging a heterogeneous tissue, such as during an interventional medical procedure (e.g., laparoscopy, endoscopy, surgery, etc.), detecting a target tissue type within the heterogenous tissue and to distinguish it therefrom. Optionally, the captured and/or imaged heterogeneous tissue is in a body cavity of a subject undergoing an interventional medical procedure. Optionally, the interventional medical procedure is minimally invasive procedure such as but not limited to laparoscopy and endoscopy. Optionally, the captured and/or imaged heterogeneous tissue is extracted from a subject's body. In a non-limiting example, a nerve fiber within a heterogeneous tissue is detected and distinguished from surrounding tissue types such as muscle tissue, fat, bone tissue and/or blood vessels, within the heterogeneous tissue.
In some embodiments, the detected target tissue type is a nerve fiber. In some embodiment, the nerve fiber has a diameter of at least 0.5 mm, at least 0.75 mm or at least 1mm. Each possibility represents a separate embodiment. In some embodiment, the nerve fiber has a diameter in the range of 0.5 mm to 3 mm, 0.5 mm to 4 mm, 0.5 mm to 5 mm, 1 mm to 3 mm, 1 mm to 4 mm, or 1 mm to 5 mm. Each possibility represents a separate embodiment. Optionally, a myelin sheath of a nerve's axon is detected.
The terms "subject" and "patient" may be used interchangeably herein to refer to an animal, more particularly to non-human mammals and humans including prenatal forms of animals, such as, e.g., embryos or fetuses. Non-limiting examples of non- human animals include: horse, cow, camel, goat, sheep, dog, cat, non-human primate, mouse, rat, rabbit, hamster, guinea pig, pig. In one embodiment, the subject is a subject undergoing interventional medical procedure (e.g., laparoscopy, endoscopy, surgery, etc.).
According to some embodiments, there is provided a surgical tool including a light transmitter and an optical sensor coupled thereto. According to some embodiments, the surgical tool is configured for attachment to an endoscope and/or laparoscope.
As used herein the term "surgical tool" may refer to any tool configured to be used during an interventional medical procedure. The term "surgical tool" encompasses any tool configured to capture, grasp, cut coagulate, desiccate, fulgurate, seal, ultrasize and/or cauterize a target tissue. Each possibility is a separate embodiment.
Non-limiting options of suitable surgical tools include surgical blades, electrosurgical cutters, laser cutters, high-frequency ultrasound cutters, radiofrequency cutters etc., and combinations thereof. Each possibility is a separate embodiment. As used herein the term "light transmitter" may refer to any light source configured to transmit light having a wavelength selectively absorbed or reflected by nerves or otherwise enabling their selective detection and differentiation from surrounding tissues, such as but not limited to muscle tissue, fat, bone tissue and/or blood vessels. Each possibility is a separate embodiment. Non-limiting examples of suitable light transmitters include a LED (light emitting diode), a laser, and an optic fiber.
As used herein, the term "optical sensor" may refer to any light detector configured to sense light emitted by nerves in the target tissue in response to the light transmitted thereon. According to some embodiments, the optical sensor may be a digital camera configured to image the tissue. According to some embodiments, the optical sensor may include a charge-coupled device (CCD), a complementary metal- oxide semiconductor (CMOS) or a combination thereof.
According to some embodiments, the surgical tool may further include a processing circuit functionally connected to the surgical tool. According to some embodiments, the processing circuit may be an integral part of the surgical tool. Alternatively, the processing circuit may be external yet functionally connected to the surgical tool, for example through a signal transmitter. According to some embodiments, the processing circuit may be configured to determine a presence (or absence) of the nerve within the target tissue, based on a signal indicative of the emitted light, obtained from the optical sensor. According to some embodiments, the processing circuit may be configured to indicate a position of a nerve within the heterogenous tissue by performing an image analysis on the obtained image. According to some embodiments, the image analysis may include image segmentation. As used herein the term "segmentation" may refer to the process of subdividing a digital image into multiple segments (set of pixels) having similar attributes. According to some embodiments, the segmentation may be based on discontinuity, i.e. portioning of the image based on identified abrupt changes. According to some embodiments, the segmentation may be based on similarity, i.e. portioning of the image based on similar regions according to predefined criteria, such as thresholding, region growing, region splitting and merging, etc. Each possibility is a separate embodiment. According to some embodiments, the segmentation may be performed in a horizontal, vertical and/or diagonal direction. Each possibility is a separate embodiment. According to some embodiments, the surgical tool includes a cutter configured to cut and/or cauterize a target tissue. In such embodiments, the light transmitter and the optical sensor may be coupled to the cutter. In such embodiments, the optical sensor may be configured to sense light reflected from the captured tissue.
According to some embodiments, the cutter may include a surgical blade. According to some embodiments, the cutter may include an electrosurgical cutter configured to cut and/or cauterize the target tissue by providing an electrical current thereto. According to some embodiments, the cutter may include an ultrasonic transducer configured to cut and/or cauterize the target tissue via vibration. According to some embodiments, the vibration is in the range of 20,000 Hz to 60,000 Hz. As a non-limiting example, the cutter may be an ultrasonically generated frictional heat energy and electrically generated bipolar energy provider, such as but not limited to Thunderbeat surgical tissue management system (Olympus). As another non-limiting example, the cutter may provide high current and low voltage (lower than the 180 V used in conventional electro-surgery), optionally in combination with a high coaptive pressure, such as but not limited to LigaSure vessel sealing system (Covidien). As another non-limiting example, the cutter may be an ultrasound (US) transducer configured to cut tissue by ultracision, such as but not limited to Harmonic scalpel (Ethicon).
According to some embodiment, the surgical tool may be a clamping device. As used herein the terms "clamping device" and "graspers" may be used interchangeably and may refer to any device shaped with two interfacing jaws configured to capture and/or grasp tissue from both sides thereof. The term "clamping device" may further encompass clamping instruments configured to capture and modify/effect a tissue such as staplers, electronic vessel sealers, cutters and the like. According to some embodiments, the clamping device may include a pair of interfacing jaws connected (e.g., pivotally connected) at a proximal end thereof, wherein the pair of interfacing jaws is configured to capture/grasp/clamp the tissue there between. The interfacing jaws may be operable between an open configuration/state wherein a first jaw of the jaws is spaced from a second jaw of the jaws to accept a tissue, and a closed configuration/state wherein the jaws are proximate to at least partially capture the tissue between them. According to some embodiments, a cutter may be positioned on or may be an integral part of the clamping device, i.e., positioned on or integrally formed with its jaws.
Each of the light transmitter and the optical sensor may be coupled to at least one jaw of the first and the second jaws. In some embodiments, the light transmitter and the optical sensor are co-coupled to the first jaw or to the second jaw. In such embodiments, the optical sensor may be configured to sense light reflected from the captured tissue. Alternatively, each one of the light transmitter and the optical sensor is coupled to a different jaw of the first and the second jaws. In such embodiments, the optical sensor may be configured to sense light transmitted from and/or through the captured tissue. According to some embodiments, the wavelength of transmitted light is in the range of 300-1000 nm, 350-550 nm, 380-520 nm, 400-500 nm, or 400-490 nm. Each possibility represents a separate embodiment. According to some embodiments, the wavelength of transmitted light is 405 nm. According to some embodiments, the wavelength of transmitted light is 488 nm. As exemplified in the experimental examples below, a wavelength of transmitted light in the range of 400-500 nm (e.g., 405 nm, and 488 nm) may be used to distinguish nerves having a diameter in the range of 0.5 mm - 3 mm from other tissue types of a heterogeneous tissue such as muscle tissue, fat, bone tissue and blood vessels, in real time.
Throughout the following description, similar elements of different embodiments of the device are referenced by element numbers differing by integer multiples of 100. For example, a pair of jaws of Fig. 1 is referenced by the number 102, and a pair of jaws of Fig. 2, which corresponds to pair of jaws 102 of Fig. 1, is referenced by the number 202.
Reference is now made to Figs. 1A and IB, which show a clamping device 100 that may be used to grasp a tissue and detect a target tissue type to distinguish it from surrounding tissue types of the grasped tissue, in accordance with an embodiment.
To facilitate the description of clamping device 100, a longitudinal axis is indicated in Fig. 1A. The axis labelled 'longitudinal axis' refers to a central axis that runs along a length of device 100, from a proximal end 104 to a distal end 106.
Clamping device 100 includes a pair of interfacing jaws 102 pivotally connected at proximal end 104 and configured to capture a tissue (not shown) between a first jaw 102a and a second jaw 102b of interfacing jaws 102; a light transmitter 108 coupled to at least one of interfacing jaws 102 and configured to transmit light to the captured tissue, wherein a wavelength of the transmitted light is configured for detection of a target tissue type; and an optical sensor 110 coupled to at least one of interfacing jaws 102 and configured to sense light emitted by the captured tissue.
Optionally, clamping device 100 communicates with a processing circuit (not shown) configured to determine a presence of the target tissue type (e.g., nerve) within the captured tissue based on the emitted light, obtained from optical sensor 110.
Optionally, light transmitter 108 and optical sensor 110 are co-coupled to one jaw and optical sensor 110 is configured to sense light reflected from the captured tissue. Optionally, light transmitter 108 and optical sensor 110 are co-coupled to first jaw 102a. Alternatively or additionally, light transmitter 108 and optical sensor 110 are co-coupled to first jaw 102a or to second jaw 102b.
Reference is now made to Figs. 2 A and 2B, which show a clamping device 200 that may be used to grasp a tissue and detect and/or distinguish a target tissue type from the surrounding tissue grasped by clamping device 200, in accordance with an embodiment. Clamping device 200 is substantially similar to clamping device 100 described in Figs. 1A-B with the notable difference that each of a light transmitter 208 and an optical sensor 210 of clamping device 200 is coupled to a different jaw of interfacing jaws 202 of clamping device 200, and optical sensor 210 is configured to sense light transmitted from and/or through the captured tissue. As shown in Figs. 2A and 2B, light transmitter 208 may be coupled to a first jaw 202a of interfacing jaws 202 and optical sensor 210 may be coupled to second jaw 202b of interfacing jaws 202. Alternatively or additionally, light transmitter 208 is coupled to second jaw 202b and optical sensor 210 is coupled to first jaw 202a.
Reference is now made to Figs. 3 A and 3B, which show a laparoscopic clamp 300 that may be used to capture a tissue in a body cavity and detect a target tissue type within the captured tissue, in accordance with an embodiment.
Laparoscopic clamp 300 is substantially similar to clamping device 200 described in Figs. 2A-B with the notable difference that laparoscopic clamp 300 is adapted to be inserted into a body cavity, such as, in a non-limiting example, through a working channel of a laparoscope which may extend through a body wall into the body cavity. Similarly, to clamping device 200, laparoscopic clamp 300 includes a pair of interfacing jaws 302 pivotally connected at their proximal end 304 to cylindrical elongated body 303 and configured to capture a tissue (not shown) between a first jaw 302a and a second jaw 302b of interfacing jaws 302; a light transmitter 308 and a light emitter 310, wherein light transmitter 308 is coupled to first jaw 302a and a light emitter 310 is coupled to second jaw 302b.
Laparoscopic clamp 300 may be sized and designed according to a desired laparoscopic procedure. Optionally, a length of jaws 302 of laparoscopic clamp 300 as measured from a proximal end 304 to a distal end 306 ranges from 20 mm to 80 mm, 20 mm to 60 mm, 20 mm to 40 mm, 20 mm to 80 mm, 20 mm to 60 mm, 20 mm to 40 mm, 30 mm to 80 mm, 30 mm to 60 mm, or 30 mm to 40 mm. Each possibility represents a separate embodiment. Optionally, a cross sectional diameter of jaws 302 measured at distal end 306 may range from 2 mm-8 mm in a closed configuration/state to 5 mm to 12 mm in an open configuration.
As a non-limiting example as illustrated in Fig. 3A, a length of laparoscopic clamp 300 as measured from a proximal end 304a of cylindrical elongated body 303 to a distal end 306 of jaws 302b is about 30 mm. A cross sectional diameter of laparoscopic clamp 300, in its closed configuration/state, is substantially constant throughout its length and ranges from 1.5 mm to 3 mm. The cross-sectional diameter of laparoscopic clamp 300 in its open configuration/state increases gradually from proximal end 304 to distal end 306, and ranges from 5 mm to 6 mm at distal end 306.
Reference is now made to Fig. 4, which is a flow chart of the method for detecting a target tissue type within a tissue, operative, for example, in accordance with the device of Figs. 2, in accordance with an embodiment.
A tissue is captured between a first jaw and a second jaw of a pair of jaws (step 420). According to some embodiments, the tissue is captured within a body cavity of a subject. Optionally, in such embodiments, the pair of jaws are inserted into a body during surgery.
Light, having a wavelength configured for detection of a target tissue type, is transmitted from a light transmitter coupled to at least one of the first and second jaws to the captured tissue (step 422). Optionally, the wavelength of transmitted light is in the range of 350-550. Optionally, the target tissue type is a nerve. The nerve may be a nerve fiber having a diameter in the range of 0.5-3 mm. Light emitted by the captured tissue is sensed by an optical sensor coupled to at least one of the first and second jaws (step 424). Optionally, a presence of the target tissue type within the captured tissue is determined based on emitted light is determined. Optionally, an indication to the user is provided if the target tissue type (e.g., a nerve) is present in the captured tissue.
At least some of or part of steps 420, 422, and 424 may be performed simultaneously and/or sequentially. Additionally or alternatively, each of steps 420, 422, and 424 may be initiated in an interchangeable order.
Experimental example
The devices and methods described herein above, were experimentally validated for the ability to detect and distinguish nerves from surrounding tissue types.
To this end samples of different tissue types were obtained from a pig, each sample had a thickness of 2-3 mm and was 2-3 mm in length and width. The obtained samples included blood vessels, fat tissue extracted from a pig's omentum, obturator nerve, and rectus abdominis muscle and an neuromuscular junction and/or exon in neuromuscular junction. The extracted samples were imaged with white light, or a wavelength of 488 nm.
As demonstrated in Figs. 5A-5H when the samples were imaged with a wavelength of 488 nm, only the nerve was visible. Further, the neuromuscular junction was distinguished from the surrounding rectus abdominis when imaged with a wavelength of 488 nm (Fig. 5H).
Next a heterogeneous tissue sample having a nerve surrounded by muscle tissue was imaged with white light, a wavelength of 405 nm, or a wavelength of 488 nm. When imaged with white light the nerve was not distinguishable from the muscle tissue (Fig. 6A). Notably, when the heterogeneous tissue was imaged with a wavelength of 405 nm (Fig. 6B) or 488 nm (Fig. 6B) only the nerve was visible and not the muscle tissue.
The results demonstrated in Figs. 5A-H and 6A-C indicate the ability to distinguish the nerve from surrounding tissue types when visualizing the tissue with a wavelength of 405 nm or 488 nm. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" or "comprising", when used in this specification, specify the presence of stated features, integers, steps, operations, elements, or components, but do not preclude or rule out the presence or addition of one or more other features, integers, steps, operations, elements, components, or groups thereof. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
Unless specifically stated otherwise, as apparent from the following discussions, it is appreciated that throughout the specification discussions utilizing terms such as "processing", "computing", "calculating", "determining", "estimating", or the like, refer to the action and/or processes of a computer or computing system, or similar electronic computing device, that manipulate and/or transform data represented as physical, such as electronic, quantities within the computing system's registers and/or memories into other data similarly represented as physical quantities within the computing system's memories, registers or other such information storage, transmission or display devices.
Embodiments of the present invention may include apparatuses for performing the operations herein. This apparatus may be specially constructed for the desired purposes, or it may comprise a general-purpose computer selectively activated or reconfigured by a computer program stored in the computer. Such a computer program may be stored in a computer readable storage medium, such as, but not limited to, any type of disk including floppy disks, optical disks, CD-ROMs, magnetic-optical disks, read-only memories (ROMs), random access memories (RAMs), electrically programmable read-only memories (EPROMs), electrically erasable and programmable read only memories (EEPROMs), magnetic or optical cards, or any other type of media suitable for storing electronic instructions, and capable of being coupled to a computer system bus.
The processes and displays presented herein are not inherently related to any particular computer or other apparatus. Various general-purpose systems may be used with programs in accordance with the teachings herein, or it may prove convenient to construct a more specialized apparatus to perform the desired method. The desired structure for a variety of these systems will appear from the description below. In addition, embodiments of the present invention are not described with reference to any particular programming language. It will be appreciated that a variety of programming languages may be used to implement the teachings of the inventions as described herein.
The invention may be described in the general context of computer-executable instructions, such as program modules, being executed by a computer. Generally, program modules include routines, programs, objects, components, data structures, and so forth, which perform particular tasks or implement particular abstract data types. The invention may also be practiced in distributed computing environments where tasks are performed by remote processing devices that are linked through a communications network. In a distributed computing environment, program modules may be located in both local and remote computer storage media including memory storage devices.
While a number of exemplary aspects and embodiments have been discussed above, those of skill in the art will recognize certain modifications, additions and subcombinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced be interpreted to include all such modifications, additions and sub-combinations as are within their true spirit and scope.

Claims

1. A method for detecting a presence of a nerve in a tissue, the method comprising: capturing a tissue between a first jaw and a second jaw of a pair of interfacing jaws pivotally connected at a proximal end thereof;
transmitting light from a light transmitter, coupled to at least one of the first and the second jaws, to the captured tissue, wherein a wavelength of the transmitted light is configured for detection of a target tissue type;
sensing light emitted from the captured tissue by an optical sensor coupled to at least one of the first and the second jaws; and
determining a presence or absence of a nerve within the captured tissue based on the sensed light.
2. The method of claim 1 , wherein the capturing step is performed within a body of a subject during a surgical procedure.
3. The method of claim 1 , further comprising the step of inserting a surgical device comprising the pair of interfacing jaws into a body of a subject.
4. The method of claim 1, wherein at least one of the first jaw and the second jaw comprises or is associated with a cutter.
5. The method of any one of claims 1-4, wherein the wavelength of transmitted light is in the range of 350-550 nm.
6. The method of claim 5, wherein the wavelength of transmitted light is 405 nm.
7. The method of claim 5, wherein the wavelength of transmitted light is 488 nm.
8. The method of any one of claims 1-7, wherein the nerve is a nerve fiber having a diameter in the range of about 0.5-3 mm.
9. The method of any one of claims 1-8, further comprising providing an indication to a user as to whether a nerve is present in the captured tissue.
10. The method of any one of claims 1-9, further comprising a step of cutting the captured tissue if an absence of a nerve in the captured tissue is determined.
11. The method of any one of claims 1 -9, further comprising providing an indication to the user to refrain from cutting through the captured tissue if a presence of a nerve in the captured tissue is determined.
12. The method of any one of claims 1-11, wherein the light transmitter and the optical sensor are both coupled to the first jaw or to the second jaw, and the optical sensor is configured to sense light reflected from the captured tissue.
13. The method of any one of claims 1-11, wherein each of the light transmitter and the optical sensor is coupled to a different jaw of the first and the second jaws, and the optical sensor is configured to sense light transmitted through the captured tissue.
14. The method of any one of claims 1-13, wherein the light transmitter comprises a light emitting diode (LED).
15. The method of any one of claims 1-13, wherein the light transmitter comprises a laser.
16. The method of any one of claims 1-13, wherein the light transmitter comprises an optic fiber.
17. The method of any one of claims 1-16, wherein the optical sensor comprises a CCD, CMOS or a combination thereof.
18. A clamping device comprising:
a pair of interfacing jaws pivotally connected at a proximal end thereof, wherein said clamping device is configured to capture a tissue between a first jaw of said jaws and a second jaw of said jaws;
a light transmitter coupled to at least one of said first and said second jaws; and an optical sensor coupled to at least one of said first and said second jaw, wherein said light transmitter is configured to transmit light to the captured tissue, and said optical sensor is configured to sense light emitted from the captured tissue, wherein a wavelength of the transmitted light is configured for detection of a nerve in the captured tissue.
19. The device of claim 18, further comprising a processing circuitry functionally connected with said clamping device, said processing circuitry is configured to determine a presence or absence of the nerve within the target tissue, based on a signal received from said optical sensor.
20. The device of any one of claims 18-19, wherein said light transmitter and said optical sensor are both coupled to said first jaw or to said second jaw, and said optical sensor is configured to sense light reflected from the captured tissue.
21. The device of any one of claims 18-19, wherein each of said light transmitter and said optical sensor is coupled to a different jaw of said first and said second jaws, and said optical sensor is configured to sense light transmitted through the captured tissue.
22. The device of any one of claims 18-21, wherein the wavelength of transmitted light is in the range of 350-550nm.
23. The device of any one of claims 18-21, wherein the wavelength of transmitted light is about 405nm.
24. The device of any one of claims 18-21, wherein the wavelength of transmitted light is about 488nm.
25. The device of any one of claims 18-24, wherein at least one of said first jaw and said second jaw comprises or is associated with a cutter.
26. The device of any one of claims 18-25, wherein said light transmitter comprises a LED.
27. The device of any one of claims 18-25, wherein said light transmitter comprises a laser.
28. The device of any one of claims 18-25, wherein said light transmitter comprises an optic fiber.
29. The device of any one of claims 18-28, wherein said optical sensor comprises a CCD, CMOS or a combination thereof.
30. The device of any one of claims 18-25, configured for attachment to an endoscope and/or laparoscope.
31. A surgical tool comprising:
a cutter configured to cut and/or cauterize a target tissue;
a light transmitter coupled to said cutter; and
an optical sensor coupled to said cutter,
wherein said light transmitter is configured to transmit light to the target tissue, when said cutter is juxtaposed said target tissue, wherein said optical sensor is configured to sense light emitted from the target tissue in response to the light transmitted thereon, wherein a wavelength of the transmitted light is configured for detection of a nerve within the target tissue.
32. The surgical tool of claim 31, further comprising a processing circuit functionally connected with said surgical tool, said processing circuit configured to determine a presence of the nerve within the target tissue, based on a signal received from said optical sensor.
33. The surgical tool of any one of claims 31-32, wherein surgical tool comprises a pair of interfacing jaws pivotally connected at a proximal end thereof, wherein said pair of interfacing jaws is configured to capture the tissue between a first jaw of said jaws and a second jaw of said jaws.
34. The surgical tool of claim 33, wherein said light transmitter is coupled to at least one of said first and said second jaws; and wherein said optical sensor is coupled to at least one of said first and said second jaw.
35. The surgical tool of claim 34, wherein said light transmitter and said optical sensor are co-coupled to said first jaw or to said second jaw, and said optical sensor is configured to sense light reflected from the captured tissue.
36. The surgical tool of claim 34, wherein each of said light transmitter and said optical sensor is coupled to a different jaw of said first and said second jaws, and said optical sensor is configured to sense light transmitted through the captured tissue.
37. The surgical tool of any one of claims 31-36, wherein the wavelength of transmitted light is in the range of 350-550nm.
38. The surgical tool of any one of claims 31-36, wherein the wavelength of transmitted light is about 405nm.
39. The surgical tool of any one of claims 31-36, wherein the wavelength of transmitted light is about 488nm.
40. The surgical tool of any one of claims 31-39, wherein said cutter comprises an ultrasonic transducer configured to cut and/or cauterize said target tissue via vibration.
41. The surgical tool of claim 40, wherein the vibration is in the range of 20,000Hz to 60,000Hz.
42. The surgical tool of any one of claims 31-39, wherein said cutter comprises a surgical blade.
43. The surgical tool of any one of claims 31-42, further comprises a stapler.
44. The surgical tool of any one of claims 31-39, wherein said cutter comprises an electrosurgical cutter configured to cut and/or cauterize said target tissue by providing an electrical current thereto.
45. The surgical tool of any one of claims 31-44, wherein said light transmitter comprises a LED.
46. The surgical tool of any one of claims 31-44, wherein said light transmitter comprises a laser.
47. The surgical tool of any one of claims 31-44, wherein said light transmitter comprises an optic fiber.
48. The surgical tool of any one of claims 31-47, wherein said optical sensor comprises a CCD, CMOS or a combination thereof.
49. The surgical tool of any one of claims 31-48, configured for attachment to an endoscope and/or laparoscope.
PCT/IL2018/050656 2017-06-16 2018-06-14 Spectroscopic clamper for real time nerve detection WO2018229771A1 (en)

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