The present invention is in the field of anesthesiology, and, in particular, devices and apparatuses that provide for both laryngoscopy and endotracheal intubation for anesthesia and for subsequent examination, surgery and/or other procedures to be performed on the upper airway of a patient.
Endotracheal intubation provides the current preferred method for control of the airway for mechanical ventilation. One goal of the intubation process is to locate the distal end of an endotracheal tube in the larynx with the proximal end outside the patient's mouth in order to establish an airway. A laryngoscope is inserted into the mouth of the patient so that the distal end of the instrument is located in the glottis, adjacent to the vocal cords. An endotracheal tube is slid through the instrument during or after insertion of the instrument.
Additionally, laryngoscopes are also used to enable a physician to observe and operate on structures of the airway and other portions of the neck and throat anatomy, all while the patient is under anesthesia. Historically, such access for observation and surgery is provided by use of a special purpose laryngoscope, such as the anterior commissure laryngoscope. The anterior commissure laryngoscope provides the physician with a direct line-of-sight view of the larynx for intubation and subsequent observation or surgery, such as laser surgery or biopsy. The anterior commissure laryngoscope, however, can require substantial mechanical force to straighten a patient's airway. This application of substantial force can injure patients.
Observation of or surgery on a patient's upper airway or other related structures of the anatomy can require the use of many different instruments, sometimes during the same procedure. For example, a physician might employ a flexible bronchoscope, including one with a laser capable of targeting and destroying tissue. The physician might need to supply light to enhance visibility of the region, might need to supply jet ventilation to the area during this procedure, and might need to remove smoke from burning tissue. The physician might need to introduce forceps or biopsy needles into the airway during a procedure. These are only examples of the kinds of instruments a physician might want to introduce into a patient's upper airway.
All laryngoscopes and/or their associated accessories come into direct contact with patient tissues and bodily fluids. Many laryngoscopes have restrictions on the methods that can be used to sterilize them due to having parts that can be damaged or destroyed by autoclaving or rough handling. Laryngoscopes therefore need to undergo time consuming, high level disinfection procedures before being re-used on subsequent patients. This leads to delay and reduced cost effectiveness. The advent of more intense use of medical equipment which encounters intimate contact with patients has led to the need to provide adaptable equipment that requires a minimum of down time.
Preferred and alternative examples of the present invention are described in detail below with reference to the following drawings:
A multipurpose, single-use, observational and surgical platform adapted for intubation procedures and for subsequent examination and/or surgery in the upper airway and related anatomy (ear-nose-throat or ENT). The observational and surgical platform includes a substantially transparent laryngoscope which can include a channel for a camera or other viewing device to assist the operator in positioning the laryngoscope without requiring excessive or undesirable manipulation of the patient's head, neck, and other anatomy.
The laryngoscope is further equipped with at least one channel through which an operator can pass instruments for observation and/or surgery of the upper airway. During use, the channel's entry port remains outside the patient so that the operator can insert an instrument into it, while the exit port is nearer the distal end of the laryngoscope and the portion of the patient's anatomy of interest to the operator. In a preferred embodiment, the entry and exit ports of the channel are inclined to one another at a partially curved and/or an obtuse angle. The channel also preferably is configured to be able to convey a fiber optic for visual observation or delivery of therapeutic laser applications to a patient's region-of-interest by users operating the fiber optic through the transparent laryngoscope in an ergonomic manner.
The substantially transparent laryngoscope can include multiple channels, one or more of which can be visible to the operator so that the operator can visually confirm routing instruments into and through the channel or channels within the laryngoscope. In these embodiments, various instruments such as, for example, viewing optics, surgical optics and vacuum instruments may be conveyable or conveyed in separate visible channels. In yet a further embodiment, multiple instruments can be conveyable or conveyed in a single channel which has a single entrance and exit port but includes a mid-channel divider or midline to route the separate instruments.
The transparent laryngoscope can be positionable by an auxiliary support arm or scaffold structure that has moveable components to allow the operator to secure the laryngoscope in a particular position. In this manner, the operator can re-position the laryngoscope as desired to insure the correct delivery of instruments to the patient's anatomy while also enhancing the operator's own ease of use and position during use of the surgical platform.
The surgical platform includes a number of laryngoscope configurations and methods of assembly which allow reliable delivery of the relevant observation and surgical instruments through the laryngoscope at angles which reduce the mechanical forces required to obtain the access needed for diagnosis and therapy. Instruments for various procedures, such as Laser surgery, smoke evacuation and jet ventilation, can be conveyed to the patient's anatomy through or alongside embodiments of the transparent laryngoscope. This provides a single-use, multi-purpose surgical platform and intubation apparatus for ENT procedures. Other embodiments described below also provide for a lifting bar handle, video scope passages and multiple operating channels.
Embodiments disclosed herein include a single use intubation apparatus for placing an endotracheal tube by an operator using a substantially transparent laryngoscope having a curved blade, a handle, and a middle section between the blade and handle. the transparent laryngoscope has at least one channel routed through it with a first port located on the handle and a second port located in the blade, the first and second port inclined to one another at an obtuse angle. Observational and/or surgical instruments such as, for example, a fiberoptic bronchoscope, a therapeutic laser, a instrument for jet ventilation, and/or a vacuum source, can be passed into the patient's throat by passing the instrument into first port, through the channel, and out the second port. A light source may be removeably attachable to the fiber optic cable that emerges from the second port located near or beneath the blade. A viewing device may be removeably attachable to the end of the fiber optic cable entering the first port, so that light when conveyed from the light source to the region of interest via the at least one first channel provides a view of the region of interest via the viewing device. Other embodiments provide for a scaffolding structure that may securely hold and reposition the substantially transparent laryngoscope to form a surgical platform so that observation and/or surgery may be undertaken while the device remains securely positioned.
Other embodiments provide for an option for jet ventilation, such as, for example, using a laser aimed jet ventilation catheter which has a fiber optic portion which may be central or peripheral and conducts light down the catheter in such a way that the light exits at the tip and serves as a visual guide for the anesthesiologist to aim the jet past the vocal cords in a way that will not entrain particles of tissue from the operating site but will provide air flow and pressure increase in the trachea and enable oxygenation and ventilation.
The ENT surgical platform allows laser treatment to be conducted using a dedicated therapeutic laser fiber-optic which passes through a centrally disposed channel in the laryngoscope. The surgical platform allows an operator to positively control the laser's position for treatment of a patient's anatomy. The centrally disposed channel is angled to conform to the patient's airway anatomy.
Many U-shaped laryngoscope designs as shown in
With regards to the U-shaped laryngoscope,
Embodiments described below include a single use intubation apparatus for placing an endotracheal tube in a patient. The intubation apparatus includes a scaffold having a plurality of moveable members, and a transparent laryngoscope attached to the scaffold and positionable by manipulation of the scaffold's moveable members. The transparent laryngoscope includes a handle region, a blade region, and a curved middle region between the blade and handle region. The blade region is configured to engage the tongue. Coursing from the handle region through or by the middle region and the blade region is at least one channel having a handle entry port and a blade exit port. Observation and surgical instruments can be inserted into this at least one channel, including for example fiberoptic bronchoscopes, laser surgery fiber optics, vacuum lines, jet ventilation instruments, and/or other surgical and/or observational instruments. Instruments exit the port on or near the blade to provide viewing and/or surgical actions, and/or to remove obliterated tissue fragments and steam, to provide ventilation to a patient, or for other purposes. Lighted lenses having an anti-fogging device to remove breath condensation or steam condensation from therapeutic laser procedures may also be included with the device. Heretofore described embodiments include the variable laryngoscope blade sizes available in the ENT GlideScope® product line which offer the enhanced utility of differently sized laryngoscope blades for the differently sized anatomical regions that vary between patients. These embodiments also provide single-use options where disposability is advantageous to help contain the spread of diseases deemed detrimental to the public health.
Other embodiments of the scaffold attached to the transparent laryngoscope allow the re-positioning of the transparent laryngoscope to obtain a different view of and/or to convey instruments to the region of interest of the patient's anatomy via the transparent laryngoscope. The repositioning of the transparent laryngoscope may be effected by a lifting handle that is in pivotable and/or rotatable connection with the moveable members. The instrument conveyable via the transparent laryngoscope includes a jet ventilation catheter and a therapeutic laser.
Particular embodiments provide for an option to deliver jet ventilation using a laser aimed jet ventilation catheter which has a fiber optic portion which may be central or peripheral and conducts light down the catheter in such a way that the light exits at the tip and serves as a visual guide for the anesthesiologist to aim the jet past the vocal cords in a way that will not entrain particles of tissue from the operating site but will provide a flow and pressure increase in the trachea and enable oxygenation and ventilation.
The laser treatment may include a dedicated laser fiber designed to channel a therapeutic laser through a channel and control it for treatment. The laser channel is angled to conform to the patient's airway anatomy.
The ear-nose-throat (ENT) surgical platform can include a camera or HDTV video laryngoscope, a protective lifter arm, protective supports on the sides of the arm which prevent unwanted secretions from clouding the lens, and a progressively curved middle section to the tongue blade which is united to a curved and slender handle portion which has a bar for attachment to the arm connected to the operating table scaffold. The HDTV camera may be highly resolving and re-postionable to accommodate the anatomy of the patient undergoing diagnostic or surgical procedures and to be ergonomically adaptable to the attending medical staff. The progressively curvable blade may be disposable.
An embodiment of the above includes the GlideScope® video enabled ENT laryngoscope substantially similar to the intubation and surgical apparatus 10 as discussed in detail regarding
There are several advantages to the GlideScope® video enabled ENT laryngoscope over existing devices: It is capable of being used in conjunction with a variety of commercially available flexible bronchoscopes. It is capable of being used in conjunction with a variety of commercially available operating tools, including, but not limited to fiber optics for laser surgery, forceps, biopsy needles, and irrigation and vacuum lines. The shape further allows smaller forces to be used to gain access to the patient's airway anatomy, reducing the potential for injury to the patient. The design allows the ENT surgeon a variety of different configurations based on the needs of the procedure being performed, equipment available and personal preferences. An alternate embodiment allows for a disposable design of the operating platform so that the apparatus is substantially available and clean to permit sanitary use in other patients. Disposable transparent or clear plastic sheaths may be adapted to the various embodiments described herein to provide efficient execution of laryngoscopic procedures between patients.
The variable sizes and the disposable portions of provided by the ENT GlideScope® product line are amenable to reducing the spread of infectious diseases deemed critically important to the public health because essentially no parts that encounter direct patient contact are reused. The operating platform may have a number of configurations and methods of assembly but the principle remains the same. The operating stage allows delivery of the relevant observation and surgical instruments reliably and at an angle that reduces the mechanical force required to obtain the access needed for diagnosis and therapy. The ability to use medically approved laser systems and fiber optics greatly extends the utility and effectiveness of the device and allows treatment to be carried down to the level of the smaller bronchi while at the same time providing jet ventilation if this is required. Smoke evacuation is also desirable for many procedures and this feature is integrated into the disposable blade embodiment. Other embodiments include a reusable laryngoscope blade, as for example where it is desirable to have a camera attached to the undersurface of a conventional blade to foster teaching demonstrations side-by-side with conventional laryngoscopy so that the camera assembly serves as an adjunct to regular laryngoscopy.
The provision of a jet ventilation channel provides that the jet ventilation is capable of being aimed approximately within 3-4 mm of the conduit. This renders a steady aim to be confidently established by an attending anesthesiologist. The steady aim allows the easy observation of the direction of the positive pressure discharge to assure that high-pressure gas does not enter the tissues but rather entrains air to ventilate the trachea and minimize pressure buildup.
The GlideScope® laryngoscope system provides for a video enabled laryngoscope that conveys visual confirmation of airway anatomy during airway procedures. Alternate embodiments provide for a disposable shell assembly to sheath the video apparatus and to provide a disposable option. The disposable design strategy provides effective cover for the video system. The electronic package may be fully immersible for cleaning and have all of the features of the regular video Laryngoscope system so that its adoption into the medical theater does not require additional training procedures. The disposable shell assembly is configured to have structural strength and durability to withstand sanitizing procedures.
The utility of a disposable shell option is that it provides the possibility of having a number of blade options suited to differing applications and clinical tasks. The range includes obesity, pediatrics, persons of small stature, normal adults, training designs, and neonatal designs. Thus with one master video unit the shell size may be selected to suit the clinical situation.
A CCD or CMOS camera placed at or near a point of angulation of the blade at or near the midpoint provides for advantageous positioning of the camera at some distance from the glottic opening to allow a degree of perspective and wide angle viewing. The position of the camera may be specifically placed or otherwise have its location adjusted relative to the blade to provide a view desired by the laryngoscope user.
A heating element on or nearby the lens area acts as an anti-fog device to preserve the view when the exhaled moisture-laden air from the airway falls upon the cool lens inserted from the ambient air. This extends the utility of the intubation apparatus substantially by obviating the need for removing the apparatus from the patient for lens cleaning operations. In another embodiment, the laryngoscope is a specially sized smaller laryngoscope for pediatric use. Access and control can be extended to the laryngoscopes used for surgery on the upper and lower airways by use of video based or image capture designs.
The transparent laryngoscope 12 includes a handle 14 that encloses an handle ridge 34 configured to provide a stabilizing structure to facilitate manual re-positioning of the laryngoscope 12, or as an anchor component for engagement with the scaffold structure 11. The laryngoscope 12 also includes a cable entry port 31 for receiving a fiber optic cable 30, a tongue blade 40 having a tongue blade end 44, a middle section 38 located between the tongue blade 40 and the handle 14, and a cable exit port 35 beneath the tongue blade 40. The support band 33 secures the handle member 14 near the laryngoscope handle ridge 34. The fiber optic cable 30 may be a bronchoscope cable or a fiber optic cable associated with a surgical laser. Yet other embodiments include the cable 30 housing an electronic optical chip having an integral camera, for example a CMOS chip located at end of the cable 30 emerging benath the tongue blade 40.
The laryngoscope with a disposable or reusable handle portion and lifter portion can have at or near its mid-portion an attached or inserted flexible video camera scope or high definition television (HDTV) to transmit to the operator the image from forward along the blade in a direction away from the handle and toward the tip and the airway. The laryngoscope can further have a disposable outer handle with multiple blade shell sizes and different angle configurations to allow an operator a choice of approaches to the airway in different anatomical situations, such as with different anatomical dimensions of individuals of differing age or for teaching reasons.
Yet other particular embodiments include a single-use laryngoscope having a handle area with a taper that permits advancement into the oral cavity, and a progressive curve which continues at a point of definition determined by a change in construction, texture or ridging form into the blade portion which has a continuous curvature. In this embodiment the laryngoscope is capable of continuous adjustment to adapt to various sizes of anatomy from small persons to large persons and the video camera or other viewer is located in the mid portion of the blade area to permit viewing around a corner, including at an angle ranging between 15 degrees and 90 degrees. The heater element of the single use laryngoscope may be removably connected to the flexible video scope to substantially heat the distal tip to approximately 40 degrees C.
The laryngoscope core may include a flexible geometry means to enable flexible adaptation to differing configurations of the shell. Other embodiments may provide for a light on the proximal or handle portion which trans-illuminates a translucent disposable laryngoscope shell to indicate the proper insertion depth by either a positive contact switch or by display of the text and graphic molded into the disposable part.
Another particular embodiment of the laryngoscope may include using a high quality video camera or a high definition television (HDTV) flexible video scope which may be removably attached to the undersurface of a U-shaped laryngoscope blade similar to those illustrated in
Other embodiments may include a channel or channels passing into the larynx area that may have a number of supportive channels dedicated from time to time to differing functions. The electronic assembly may comprise a rigid or flexible wire lead to a camera which has a heated lens, a light emitting diode (LED) lighting array, and a charge coupled device (CCD), or a complementary metal-oxide-semiconductor (CMOS) digital video camera for real time video monitoring of the airway for intubation and diagnosis. Other laryngoscope embodiments provide for connecting two bivalve halves to create an integrated whole unit that functions as a laryngoscope to enable visualization of the airway through a frontal portal permitting the passage of light and an uninterrupted image.
Particular embodiments of the laryngoscope may further include a retaining part or caps on the entry port for the laryngoscope that stabilizes the scope and prevents unwanted rotation or longitudinal motion and permits the scope channel to be used as suction. A suction channel joining one of the functional channels may be used to permit smoke evacuation. Other laryngoscope embodiments may include a channel or channels that allow the passing into the larynx area of a standard curve that will enable passage of either a flexible scope or a rigid special purpose scope. The laryngoscope may be configured to provide an aimable channel or channels passing into the larynx area that may be a dedicated channel for jet ventilation. Yet other embodiments of the laryngoscope may provide for shifting of Jet Ventilation channel from the right side to the left side as required to permit unobstructed viewing and treatment of the opposing side of the larynx.
While the preferred embodiment of the invention has been illustrated and described, as noted above, many changes can be made without departing from the spirit and scope of the invention. For example, the apparatus 11 may be configured to support the non-transparent laryngoscope 25 illustrated in
This application claims priority to and incorporates by reference in its entirety U.S. Provisional Patent Application No. 61/029,268 filed Feb. 15, 2008. This application describes embodiments that can be usefully combined with, or used in conjunction with applicant's other inventions described in the following patents and co-pending applications, each and all of which are incorporated by reference in their entirety: U.S. Pat. No. 6,142,144 filed as U.S. patent application Ser. No. 09/060,891 on Apr. 15, 1998; U.S. Pat. No. 6,655,377 filed as U.S. patent application Ser. No. 10/356,705 on Jan. 30, 2003; U.S. patent application Ser. No. 11/285,743 filed Nov. 21, 2005; U.S. Provisional Patent Application No. 60/862,192 filed Oct. 19, 2006; U.S. patent application Ser. No. 11/645,086 filed Dec. 21, 2006; U.S. patent application Ser. No. 11/925,868 filed Oct. 27, 2007; U.S. Provisional Patent Application No. 61/027,377 filed Feb. 8, 2008; U.S. patent application Ser. No. 12/368,298 filed Feb. 9, 2009.
Number | Date | Country | |
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61029268 | Feb 2008 | US |