Surgery – Respiratory method or device – Respiratory gas supply means enters mouth or tracheotomy...
Reexamination Certificate
2001-04-19
2003-04-01
Lewis, Aaron J. (Department: 3761)
Surgery
Respiratory method or device
Respiratory gas supply means enters mouth or tracheotomy...
C128S207150, C128S207160, C606S108000
Reexamination Certificate
active
06539942
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to intubation and, more specifically, to an improved endotracheal intubation device through which an imaging device (e.g., a nasopharyngoscope) is inserted and manipulated to facilitate an endotracheal intubation procedure.
2. Description of the Related Art
A number of medical devices have been devised to assist with the intubation of the trachea during emergency or operative medical procedures. Typically, intubation of the trachea is required in the emergency setting to: prevent aspiration of gastric contents into the lungs; provide an adequate airway to the lungs; therapeutically alter the level of CO2 in the blood stream; and provide anesthetic gases to patients in the operating room. Problems with the technique are that, often, intubation is neither easy nor non-traumatic for the patient. Several factors contribute to the problem. First, there are many variations in the length of the trachea among patients. Second, once the tube is inserted, the device is difficult to manipulate and/or adjust due to limited flexibility in the medical instrument. Third, the trachea is often difficult to visualize due to anatomic variabilities such as anterior larynx, inability to open mouth, decreased neck mobility (may be secondary to spinal immobilization or anatomy), etc.
In performing an intubation procedure, an instrument, i.e., a laryngoscope, is first introduced into the patient's mouth, and the tongue of the patient is elevated so that the patient's vocal cords and epiglottis can be clearly identified. In practice, the medical practitioner can find this difficult to accomplish because of physical and anatomical variations among patients. Thus, the practitioner is often left to rely on prior experience or “blind faith” with a touch or feel technique. This can be harmful to the patient, especially as to proper identification of the patient's vocal cords.
While the length of the trachea for individual patients is usually classified by a patient's teeth-bifurcation distance, there is no absolute standard. Thus, there is a need for a medical instrument which provides access to the vocal cords without the hazards associated with conventional art devices. It is desired to provide a medical device which utilizes an untethered flexible tubular endotracheal device and sheath that flexes into a L-shape, for accessing the vocal cords under the direct visualization of an enclosed imaging device (e.g., a nasopharyngoscope). The instant invention answers the need.
U.S. Pat. No. 2,975,785 issued to Sheldon discloses an optical viewing instrument comprising an endoscope sheath and a plurality of tube elements arranged in an end to end relationship. One end of the sheath is secured to a control housing and has its interior end in communication with the interior chamber of the housing. The control housing serves to support various control structures for the endoscope, and includes two mating castings and a plurality of cables which are secured to a terminal end of the sheath with the other ends of the cables secured and looped around a pair of pulleys positioned within the chamber. The optical system consists of a flexible bundle of optically aligned transparent glass fibers which are secured by a pair of clamps. Each of the glass fibers of a bundle of this sort transmits light from one end by multiple internal reflections within the fiber. The bundle size of the fibers limits the overall flexibility of the instrument.
U.S. patents issued to Bazinet (U.S. Pat. No. 3,162,214), Takahashi et al. (U.S. Pat. No. 4,236,509) and Petruzzi (U.S. Pat. No. 4,669,172) disclose flexible tubular structures composed of coiled wire and/or tethered circular ring elements which provide for more flexibility in the use of an inserted endoscope. Petruzzi discloses a method for fabricating a flexible shaft comprising a spiral cut member having an essentially uniform inside diameter and a tapered linear profile coextensive with at least a portion of the spiral cut member. This flexible shaft is fabricated initially by progressively removing a portion of the exterior wall along a segment of a relatively rigid tube thereby forming a substantially tapered profile.
While the shapes and contours of the aforementioned tubular structures have added flexibility in the use of endoscopes, bending devices coupled thereto have proven advantageous to extend flexibility and control of flexibility. For example, patents respectively issued and granted to Fukuda (U.S. Pat. No. 4,905,666), Chikama (U.S. Pat. No. 5,520,222) and Ogino (JP 5,329,095) teach bending devices which use tethers linked to the tubular structures via pulleys or chain driven winding mechanisms. These features add to the complexity of the device, and are prone to mechanical failure, rendering the endoscopic device inoperable.
U.S. Pat. No. 4,861,153 issued to Berci discloses an intubating video endoscope which includes an elongated sheath member with a selectively controllable bendable section housing an image forming optical system. A generally rigid section includes a control housing. An image transmitting optical system extends throughout the length of the sheath member and terminates behind and adjacent to the image forming system. A light transmitting system also extends throughout the length of the sheath member to the image forming optical system, the rearward end of which is adapted to be operatively connected to a light source. A channel, extending through out the length of the sheath member, provides a flow of pressurized gas which is directed across the image forming optical system to keep the image forming optical system operationally clear.
U.S. Pat. No. 4,949,716 issued to Chenoweth discloses a hand held medical device with a wide range of nasally placed airway tubes to afford better control of airway tubes. A soft flexible manipulator containing a spring controls the airway tube. A stethoscope headset provides an audible reference for guiding the airway tube, and affords an additional reference to confirm the proper placement of the airway tube. An endotracheal device having similar features is disclosed in the PCT application of Adair (WO 91/120044), except that the handle has an oxygen supply conduit for supplying oxygen to the patient during the intubation process.
None of the above inventions and patents, taken either singularly or in combination, is seen to describe the instant invention as claimed. Thus a endotracheal intubation device solving the aforementioned problems is desired.
SUMMARY OF THE INVENTION
The invention is a device to facilitate intubation, the device having a hand-grip control mechanism for selectively controlling the amount of curvature at the distal end of the device. The device is inserted into a conventional endotracheal tube. A conventional imaging device, e.g., a nasopharyngoscope, is inserted centrally through the device. The device is formed into an L-shaped position by the handgrip. This L-shaped position facilitates proper visualization of the vocal cords.
The L-shaped configuration is produced via a series of interlinked and truncated ring like elements disposed along the distal portion of the tube. A wire passing through the tube from the interlinked rings to the handgrip activates the L-shaped configuration. The amount of force applied to the handgrip controls the degree of bend in the distal end of the device. A standard nasopharyngoscope is inserted through the center of the device, and the device is then inserted into a standard endotracheal tube. The tip of the nasopharyngoscope extends to or just beyond the end of the endotracheal tube which allows an operator to visualize the vocal cords. This allows proper intubation without damaging the vocal cords.
Once the tube combination is in place in the patient, the handgrip is released to relax the L-shaped configuration and the device including the scope is removed, leaving the tube in place. In a preferred embodiment, the device is made of a lightweight s
Schwartz John
Schwartz Richard
Erezo Darwin P.
Lewis Aaron J.
Litman Richard C.
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