About 150,000 thyroid surgeries and 40,000 parathyroid surgeries are performed in the United States per year. There is a lack of devices on the market specifically designed for endotracheal tube stabilization after vocal cord alignment with endotracheal tube surface electrodes.
Precise positioning of endotracheal tube electrodes with the vocal cords is commonly desired in surgeries where the vocal cords are at risk. Vocal chords are innervated by branches of cranial nerve. Neurophysiological techniques sometimes use electomyography (EMG) for monitoring and identification of cranial nerves.
Surgeries that commonly uses this form of interoperative neurological monitoring (IONM) include thyroidectomy, parathyroidectomy, and craniotomy procedures. In the operating room, alignment of endotracheal tube surface electrodes with the vocal cords is often achieved through use of visual observation during intubation.
Some practices and institutions will place rolled up pads in between the teeth on both sides of the ET tube, and then tape down the tube to the face around the upper and lower lip area. Current attempts to maintain ET tube electrode alignment during the course of these operations using such strategies occasionally fails, increasing the likelihood of false positive and false negative EMG feedback.
This can potentially put the patient at risk, which is why the development of a new and improved system is desirable.
The present disclosure provides for an endotracheal tube placement system. The system can include a clamp, a clamp lock, and at least one optional between-the-teeth positioner. The clamp may be adapted to be coupled to a patient's face via tape or other suitable mechanism. The clamp can be shaped to receive an endotracheal tube in a tube-receiver passageway and can be configured to move from an unclamped position to a clamped position. When the clamp is in the unclamped position, the endotracheal tube is free to slide through the tube-receiver passageway. When the clamp is in the clamped position, the endotracheal tube is engaged by the clamp to resist movement through the tube-receiver passageway. The clamp lock configured to selectively retain the clamp in the clamped position to hold the endotracheal tube in place relative to the clamp.
In illustrative embodiments, the at least one between-the-teeth positioner is sized to be placed between upper and lower teeth of a patient when the clamp is coupled to the patient's face. The at least one between-the-teeth positioner can be coupled to the clamp.
In illustrative embodiments, the at least one between-the-teeth positioner can include left and right positioners movably coupled to the clamp. Each of the at least one between-the-teeth positioner can include a flexible tether coupled to the clamp and a bite member coupled to the flexible tether opposite the clamp. The bite member can be sized to space upper and lower teeth of the patient apart from one another a preselected distance greater than the tube-receiver passageway defined by the clamp.
In illustrative embodiments, the clamp can include a generally U-shape member with two legs (i) that are coupled to one another at a closed end of the clamp and (ii) that are free of one another at a free end of the clamp. The at least one positioner can include left and right positioner holders each coupled to a corresponding left or right leg of the clamp outside the tube-receiver space between the two legs of the clamp. Each of the left and right positioner holders can be shaped to receive a bite member moving therethrough so that each of the left and right bite members can be guided into place between upper and lower teeth of the patient at a location spaced from the endotracheal tube. In some designs, the bite member of each of the at least one between-the-teeth positioner has a generally cylindrical shape and the left and the right positioner holders are each formed to include a round opening sized to correspond to a cross-sectional size of the generally cylindrical shape.
According to another aspect of the present disclosure, an endotracheal tube placement system can include a clamp and a clamp lock. The clamp can be adapted to be mounted relative to a patient's mouth by tape strips or other suitable means. The clamp can have a generally U-shape member with a left leg and a right leg (i) that are coupled to one another at a closed end of the clamp and (ii) that are free of one another at a free end of the clamp. The clamp can be shaped to receive an endotracheal tube in a tube-receiver passageway between the left leg and the right leg. The clamp can further be configured to move elastically from a normally unclamped position in which the endotracheal tube is free to slide through the tube-receiver passageway to a clamped position in which the endotracheal tube is engaged by the clamp to resist movement through the tube-receiver passageway. T clamp lock can be configured to selectively retain the clamp in the clamped position to hold the endotracheal tube in place relative to the clamp and, in turn, the patient's mouth after the tube has been inserted through the clamp and into a patient's throat so as to reduce movement of the endotracheal tube out of a preselected position relative patient biological features.
In illustrative embodiments, the clamp lock is located between the closed end and the free end of the left and the right leg of the clamp and is spaced apart from the free end of the two legs of the clamp. The clamp lock can be provided by a sawtooth fastener having at least one catch tooth coupled to one of the left and the right leg of the clamp and a latch tooth coupled to the other of the left and the right leg of the clamp. The latch tooth can be configured to engage a catch tooth upon movement of the left leg of the clamp toward the right leg of the clamp and thereby hold the clamp in the clamped position.
In illustrative embodiments, the clamp lock can include a release lever that extends from one of the catch teeth or the latch tooth. The release lever can be generally parallel to one of the left leg or the right leg of the clamp. The release lever can be configured to be pressed by a user to disengage the latch tooth from one of a catch tooth freeing the clamp to return to the normally unclamped position from the clamped position. The clamp lock can be located about mid-way between the closed end and the free end of the left and the right leg of the clamp.
In illustrative embodiments, the system can include left and right between-the-teeth positioners. The between-the-teeth positions can be sized to be larger than the endotracheal tube for placement between upper and lower teeth of a patient when the endotracheal tube placement system is arranged over the patient's mouth. The left and right positioners can be movably coupled to the clamp.
In illustrative embodiments, each of the left and the right positioners includes a tether that extends from a corresponding left or right leg of the U-shape member included in the clamp and a bite member coupled to the tether opposite the corresponding left or right leg of the clamp. The bite member can be sized to space upper and lower teeth of the patient apart from one another a preselected distance greater than the size of the tube-receiver passageway.
In illustrative embodiments, the system can include left and right positioner holders coupled to a corresponding left or right leg of the clamp outside the tube-receiver passageway between the two legs of the clamp. Each of the left and right positioner holders can be shaped to receive a bite member moving therethrough so that each of the left and right bite members can be guided into place between upper and lower teeth of the patient at a location spaced from the tube-receiver passageway.
According to another aspect of the present disclosure, an endotracheal tube placement system can include a clamp, a clamp lock, and tape strips. The clamp can be adapted to be mounted relative to a patient's mouth. The clamp can include a endotracheal tube grip that defines a tube-receiver passageway sized to receive an endotracheal tube and a clamp mount that extends upwardly and downwardly from the endotracheal tube grip to provide structure suitable for fixation to a patient above and below the patient's mouth. The clamp can be configured to move elastically from a normally unclamped position in which the endotracheal tube is free to slide through the tube-receiver passageway to a clamped position in which the tube-receiver passageway is sized to engage of the endotracheal tube resisting movement through the tube-receiver passageway. The clamp lock can be configured to retain the clamp in a the clamped position. The tape strips can be adhered to the clamp mount of the clamp at locations spaced above and below the tube-receiver passageway. Tape strips can be adapted to be further adhered to the patient above and below the patient's mouth to fix the clamp to the patient while remaining spaced apart from an endotracheal tube that may be arranged in the tube-receiver passageway.
In illustrative embodiments, the clamp mount is provided by an elastic member having left and right legs arranged along left and right sides of the endotracheal tube grip. The clamp lock can be provided by a sawtooth fastener having a series of catch teeth coupled to one of the left and the right leg and a latch tooth coupled to the other of the left and the right leg. In illustrative embodiments, the clamp lock can include a release lever that extends from one of the catch teeth or the latch tooth generally parallel to one of the left leg or the right leg of the clamp.
In illustrative embodiments, the elastic member of the clamp mount has a U-shape with a closed end and a free end. The clamp lock can be located about mid-way between the closed end and the free end.
In illustrative embodiments, the system can include left and right between-the-teeth positioners. The between-the-teeth positioners can be sized to be placed between upper and lower teeth of a patient when the endotracheal tube placement system is arranged over the patient's mouth. Optionally, the left and right between-the-teeth positioners can be movably coupled to the clamp.
In some embodiments, each of the left and the right between-the-teeth positioners includes a tether that extends from the clamp and a bite member coupled to the tether opposite the clamp. The bite member can be sized to space upper and lower teeth of the patient apart from one another a preselected distance.
In illustrative embodiments, the system includes left and right positioner holders coupled to the clamp. Each of the left and right positioner holders can be shaped to receive a bite member moving therethrough so that each of the left and right bite members can be guided into place between upper and lower teeth of the patient at preselected location relative to the tube-receiver passageway.
In illustrative embodiments, the bite member of each of the left and right positions has a generally cylindrical shape. In some such embodiments, the left and the right positioner holders are each formed to include a round opening sized to correspond to a cross-sectional size of the generally cylindrical shape.
An endotracheal tube placement system 10 configured to hold an endotracheal tube 11 in a preselected position relative to a surgical patient is disclosed as suggested in
In the illustrative embodiment, the system 10 includes a tube locator 12, between-the-teeth positioners 14, and tape strips 16, 18 as shown in
The tube locator 12 is illustratively made of latex free ABS (Acrylonitrile Butadiene Styrene) plastic. The tube locator 12 is shaped to include a clamp 20, a clamp lock 22, and left/right positioner holders 24 as shown in
In the illustrative embodiment, the clamp 20 extends upwardly and downwardly from the tube 11 to provide structure over which tape strips 16, 18 can be adhered to the tube locator 12 as shown in
In other embodiments, the tube grip 26 may be an overlapped ring, a rectangular tube, a triangular tube, or any other suitable shaped grip configured to receive and selectively engage the endotracheal tube 11 around the tube-receiver passageway. Further, the mount member 28 may have other suitable shapes such as an oval or some other closed/open geometry that extends upwardly and downwardly from the tube grip 26 for adhesion to tape strips at locations spaced from the tube 11.
The clamp lock 22 of the illustrative embodiment is configured to selectively retain the clamp 20 in its clamped position as suggested in
The clamp lock 22 is further configured to enable release of the clamp 20 from the clamped position to move to its normally unclamped position as suggested in
Left and right between-the-teeth positioners 14 are used to space the bottom teeth of a patient from upper teeth so as to avoid biting of the endotracheal tube 11 as suggested in
In other embodiments, it is contemplated that other between-the-teeth positioners can be incorporated into the system 10. For example, a bite plate, arcuate mouth guard, arcuate teeth trays, and/or other suitable spacers may be used to space upper and lower teeth of the patient apart from one another a preselected distance greater than the tube-receiver passageway 21 defined by the clamp 20.
As noted earlier, the tube locator 12 of the present design includes optional left/right positioner holders 24 provided by rings as shown in
In the illustrative embodiment, an upper tape strip 16 and lower tape strip 18 are used to couple the tube locator 12 to the patient's face as suggested in
A second endotracheal tube placement system 210 configured to hold an endotracheal tube 211 in a preselected position relative to a surgical patient is disclosed as suggested in
In the illustrative embodiment, the system 210 includes a tube locator 212, between-the-teeth positioners 214, and a tape strip 216 as shown in
The tube locator 212 is illustratively made of latex free ABS (Acrylonitrile Butadiene Styrene) plastic. The tube locator 212 is shaped to include a clamp 220 and a clamp lock 222 as shown in
In the illustrative embodiment, the clamp 220 extends upwardly from the tube 211 to provide structure over which tape strip 216 can be adhered to the tube locator 212. The clamp 20 illustratively includes a U-shape member 228 forming the tube receiver space 221.
The clamp lock 222 of the illustrative embodiment is configured to selectively retain the clamp 220 in its clamped position. The clamp lock 222 includes a sawtooth fastener 230 having a series of catch teeth 231, 232 that engage a corresponding latch tooth 234 when the clamp 220 is in the clamped position. The sawtooth fastener 230 with catch teeth 231, 232 included in the clamp lock 222 are coupled to a right leg 241 of the U-shape member 228. The latch tooth 234 is coupled to a left leg 242 the member 228. In the illustrative embodiment, the clamp lock 220 is located at a free end of the U-shape member 228.
The clamp lock 222 is further configured to enable release of the clamp 220 from the clamped position to move to its normally unclamped position. In the exemplary embodiment, the clamp lock 222 includes quick release pull tabs 271, 272 that extends from the right and left legs 241, 242 of the U-shape member 228. The release pull tabs 271, 272 is configured to be pulled apart by a user to disengage the latch tooth 234 from the catch teeth 231, 232 freeing the clamp 220 to return to the normally unclamped/released position from the clamped position.
Left and right between-the-teeth positioners 214 are used to space the bottom teeth of a patient from upper teeth so as to avoid biting of the endotracheal tube 211 as suggested in
In the illustrative embodiment, an upper tape strip 216 is used to couple the tube locator 212 to the patient's face. The upper tape strip 216 is laid over the U-shape member 228 at a location spaced above the endotracheal tube 211.
The endotracheal tube placement systems 10, 210 of the present disclosure are unique in design and offers optimal security after endotracheal tube placement for vocal cord EMG recordings. The system 10 illustratively includes tape strips 16, 18, between teeth positioners 14, a quick release clamp 20 with an attached grip/release strip, and a clip or clamp lock 22.
The quick release clamp grip clip may be made of latex free ABS plastic. The quick release clamp grip clip 20, 220 will grasp the tube endotracheal tube 11, 211 after it is placed, and will be able to click open and click closed
The tape strips 16, 18, 216 can be made out of a latex free zinc oxide-based adhesive. The tape strips 16, 18 will lie midline on both the upper and lower lip, and will peel laterally along the face
The between teeth positioners 14, 214 may be made out of pliable FDA approved food grade plastic. The between teeth positioners 14, 214 will be placed in the between the teeth in the mouth with one positioner 14, 214 positioned to the left of the tube 11, 211 and the other positioner 14, 214 placed to the right of the tube 11, 211. Cotton string will attach the between teeth positioners 14, 214 to the quick release clamp grip clip. A quick release pull tab will made of latex free ABS plastic will be attached to the quick release clamp grip clip.
According to one method of using the system, before the system is used the endotracheal tube 11, 211 is first placed by the anesthesiologist and the vocal cords are lined up with the placement markers on the tube 11, 211. This tube 11, 211 is held in place by the anesthesiologist while the next steps are executed.
The quick release clamp lever 36 or tabs 271, 272 is pulled open so the endotracheal tube 11, 211 can move past the sawtooth fastener 22, 222 and fit into the tube-receiver space 21, 221. Next, the sawtooth fastener 22, 222 is tightened by pressing the U-shaped member 28, 228 closed until there is a snug and secure fit around the tube 11, 211.
Upon securing the tube 11, 211, the upper tape strip 16, 216 are unrolled and peeled laterally across the face from the upper lip area to the under ear area. Next, in certain embodiments, the lower tape strip 18 is unrolled and peeled laterally across the face from the lower lip area towards the ear lobe
The between teeth positioners 14 of certain embodiments are then each passed half way through the between teeth positioner holders 24 on their appropriate side. The between the teeth positioners 14, 214 are then placed between upper and lower teeth of a patient on opposed sides of the tube 11, 211.
The system 10, 210 can be quick release, meaning that if desired the tape can easily be unpeeled and the endotracheal tube 11, 211 can be freed from the tube locator 12, 212 simply by undoing the sawtooth fastener 22, 222. Undoing the sawtooth fastener 22, 222 can be accomplished by pulling on both ends of the pull tabs 271, 272 simultaneously or pressing the sawtooth fastener lever 36. When it's time to extubate or re-adjust the ET tube, the quick release pull tabs 271, 272 are pulled on both ends simultaneously or the sawtooth fastener lever 36 is pressed, and the quick release clamp 20, 220 will open releasing the ET tube.
Two previously used methods to reduce ET tube movement post intubation are through the use of rolled up absorption pads, commonly assembled by the anesthesia team, and tape. Rolled up absorptions pads are aimed at preventing lateral ET tube movement, but tend to become saturated with saliva and unwantingly slip. Tape is attempted to avoid multidimensional ET tube movement, but occasionally have to be unwrapped after placement if the ET tube requires realignment with the vocal cords which is cumbersome.
There are a number of ET tube securing devices produced, although it appears that few, if any, health care systems use these types of devices for vocal cord monitoring. These mechanisms are can include a neck strap, which can cause the tube to shift is the patients body position is manipulated, and/or tape which is not favorable as previously discussed.
In addition to these pitfalls of presently available ET tube securing devises, an additional factor further limiting their usage for vocal cord monitoring is unfavorable cost. Furthermore, none conveniently include positioners to be placed between the teeth which could aid in ET tube stabilization.
Some endotracheal tube holding devices include the Laerdal Thomas ET Tube Holder which uses a neck strap, Dale Medical Products ET Tube Holder Stabilock which uses a neck strap, Hollister Anchorage Oral ET Tube Fastener which uses a neckstrap, Birds and Cronin Endo-MATE ET Holder which uses a neckstrap, B&B Medical Hypoallergenic Tape II ET Holder which uses tape around the tube.
This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application Ser. No. 63/403,170, filed Sep. 1, 2022, which is expressly incorporated by reference herein.
Number | Date | Country | |
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63403170 | Sep 2022 | US |