Surgery – Specula – Laryngoscope
Reexamination Certificate
2001-09-10
2003-11-25
Robert, Eduardo C. (Department: 3732)
Surgery
Specula
Laryngoscope
C600S194000
Reexamination Certificate
active
06652453
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to laryngoscopes and more particularly to a laryngoscope that is battery powered, having an ergonomic pistol grip, flexion control, a biopsy port, suction on demand, oxygen and medication infusion capabilities, a video camera chip and objective lens and an associated lightweight portable LCD screen. The video laryngoscope is particularly useful in a procedure for intubating a patient's trachea, in routine and emergency situations.
BACKGROUND OF THE INVENTION
In the medical field, intubation is the process of putting an Endotracheal (ET) tube into a person's throat to maintain the airway either for emergency breathing, or for the delivery of oxygen and anesthetics.
Fiberoptic intubating instruments having a display and a camera are known and disclosed in patents including U.S. Pat. No. 5,827,178 to Jonathan Berall, U.S. Pat. No. 5,363,838 to Dr. Gordon George and U.S. Pat. No. 4,742,819 to Dr. Gordon George. Fiberoptic intubating instruments having a fiberoptic bundle, objective lens and an eyepiece are typified by patents U.S. Pat. No. 4,086,919 to Bullard and U.S. Pat. No. 5,183,031, to Rossoff.
U.S. Pat. No. 5,363,838, Berall teaches a laryngoscope that is similar in shape, configuration and construction to a common manual laryngoscope except that it has a view screen that would hinge on the side of the cylindrical body of the laryngoscope and a camera on the end of the laryngoscope blade to provide continuous visualization of the operating field as an adjunct to directly visualizing the pharynx. Berall also teaches that the monitor is mounted lower on the handle, close to the blade of the laryngoscope and to be along the same line of sight to the patient's throat, so that the professional intubator's direct view of the patient's larynx and simultaneous view of the screen can be achieved with no head movement. Berall also describes a laryngoscope configured to the shape of a common laryngoscope blade that does not employ any controllable ET tube gripping means. He further states that while the left hand passes the laryngoscope blade behind the base of the tongue and into the pharynx, the instrument for passing the endotracheal tube is passed conventionally using the intubator's left hand, the convention being, having a rigid laryngoscope blade and using a stylet reinforced ET tube inserted manually. Berall also describes a blade configuration that is rigid, having no built-in means to accomplish controlled articulation. The only controls cited are an on/off switch. Berall makes no claims as to open working channels on his laryngoscope to enable suction capabilities, medication or oxygen infusion, or biopsy procurement. The peripheral components of the conventional intubation procedure, including, but not limited to, suction, oxygenation and/or specimen removal are normally separate from conventional laryngoscopes and thus require separate tools.
U.S. Pat. Nos. 4,742,819 and 5,363,838 to Dr. Gordon George teaches a fiber optic intubation system, where a conventional laryngoscope is employed to directly visualize and open the airway of a patient, while a fiberoptic camera probe is passed into the throat for indirect visualization of the operating field on a separate LCD screen. The LCD screen is not integrated to the probe/camera, but communicates fiber optically from lens to the camera, and then electrically, via video cable from the camera to the separate monitor. The fiberoptic system is separate from the laryngoscope. Dr. George teaches that the probe is a semi-malleable tube that can be pre-shaped prior to insertion, and has a manipulating lever to provide flexion control. The semi-malleable tube also serves as a stylet. In conventional intubation, the stylet is a semi malleable wire that when inserted inside the ET tube, provides stiffness to reinforce and enhance maneuverability the otherwise soft and pliable ET tube for manual deployment and proper placement of said tube by the user. Dr. George does not teach any obvious controllable ET tube grasping or deployment means, nor is any grasping means necessary with the stylet technique. Dr. George teaches that the probe has a camera in the proximal end of the probe and the distal end has a lens with fiber optic means of communication to the camera, which is connected to a separate view screen. Dr George does not teach any integrated means of oxygen, medication, or suction delivery, anyone familiar with the art will recognize that the aforementioned capabilities exist as separate systems during conventional intubation. Further, Dr. George describes the intubation procedure conventionally, where separate tools are needed for suction, oxygenation and medication delivery.
U.S. Pat. No. 4,086,919, Bullard discloses a rigid fiberoptic laryngoscope with a single eyepiece that is illuminated by a fiber optic system. Bullard claims movable, grasping jaws designed to grasp hold and release an ET tube, with moveable extension means to advance the tube. The said grasping means resembles an endoscopic biopsy forceps in design, is removable and housed in an open conduit, or working channel, that is an open tube extending from one end of the probe to the other. The only work Bullard claims for the working channel is to provide a conduit for the grasping device. Oxygen, suction or medicine administration is never claimed, and cannot be done with a grasping tool inserted into and thus occluding, the working channel tube. The forgoing E.T. tube grasping system is not integral to the body of the laryngoscope.
U.S. Pat. No. 5,183,031, Rossoff claims medication, oxygen and suction capabilities in a fiberoptic laryngoscope with a single eyepiece and a pistol grip configuration, very similar in design to a bronchoscope. He further discloses his design to be used in the manner of a stylet, which is inserted into the ET tube for manual deployment by the Intubator. The inherent weakness of this design is that in order for the probe to be able to pass the “goose neck” stylet into the internal lumen of the ET tube, it needs to be of a very small diameter. The standard adult sized 8.0 endotracheal tube has an internal diameter of ¼ inch. Therefore, anyone skilled in the art would know that the stylet diameter and the diameter of the oxygen and suction ports correspondingly, must be of a very small diameter, similar to the design of a bronchoscope. Bronchoscopes generally have an external diameter of ⅛ inch and are well known to have very limited suction and infusion capabilities, inadequate for intubation. Bronchoscopic suction and oxygen capabilities, while adequate for visualization of the bronchial pathways of the lungs, are very limited and cannot handle the large volumes necessary to remove copious oral secretions or mucus, or to provide the volumes of Oxygen necessary to push open an airway or to oxygenate a patient. When a bronchoscope is used for intubation, separate suction and oxygen delivery systems are always used.
U.S. Pat. No. 5,841,491 to D'Alphonso et al, describes a fiber optic scope enhancement system that employs a digital to analog, and analog to digital converters, also known as a D/A and A/D converters respectively, to enhance images acquired by an analog camera that receives images that have been distorted by the fiber borders of a fiber optic bundle. In order to process analog images in a digital image filter, the analog images must be digitized by the A/D converter, then processed digitally, then converted back to analog by the D/A converter for eventual display by the analog television monitor. While this system of using A/D and D/A conversion may be necessary for image enhancement of analog images captured via a fiber optic bundle, it is unnecessary with a system receiving digitally acquired images that have not been distorted by a fiberoptic imaging system. The D/A conversion unit is only necessary to display digitally acquired images on an analog television or LCD monitor.
U.S. Pat. No. 4,306,547, by Lowell describes a
Smith Susan V.
Smith Vincent A.
Comstock David C
Robert Eduardo C.
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