The present disclosure relates to securing mechanisms, which may be used more specifically with endotracheal tubes.
Endotracheal intubation, placing a flexible tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs, is a medical necessity in a variety of settings including in critical care, intensive care units, or under general anesthesia. One setting that presents unique challenges is in emergency or “field” settings, such as ambulances or battlefields, where increased usability is needed. Endotracheal intubation is commonly accomplished by inserting an endotracheal tube via the mouth or nose to a sufficient depth in the trachea and holding the endotracheal tube in position. Displacement or movement of the endotracheal tube by the medical practitioner or the patient can create problems that reduce or lose the effectiveness of the artificial airway, leading to further medical emergency and even to loss of life. Therefore, securing, fixating, and/or stabilizing the endotracheal tube in the correct position help facilitate effective medical procedures and prevents complications.
A common practice for securing and maintaining the position of the endotracheal tube is to tape the tube to the face of a patient. This method has many disadvantages, including time-consuming operational setup, discomfort for patient, difficulty of removing the tube, and little opportunity for readjustment. Other tube-securing methods include complex mounting plates and applying pressure to the face of a patient and/or using straps to secure the plate to the patient. Oftentimes, the complex configurations of these mounting plates require more than one medical practitioner to set up and secure the plate to the patient. Furthermore, these complex mounting plates obstruct clear entry into the mouth of a patient, preventing other critical medical procedures, such as suction, inspection, oral care, and maintaining cleanliness of the endotracheal tube and the integrity of tissues and surfaces involved. Additionally, in current medical practice, an auxiliary tube with a balloon cuff is typically provided with an endotracheal tube and inflated after intubation to help secure the endotracheal tube and seal the tracheobronchial tree, preventing leakage of respiratory gases and contamination by undesirable materials. However, the auxiliary tube may interfere with the securing and maintenance procedures of an endotracheal tube and add discomfort to the patient. Therefore, a need exists for easily operable, time-efficient, and patient-friendly securing mechanisms for an endotracheal tube that allow effective and reliable securing of an endotracheal tube to a patient.
The inventors have recognized that an endotracheal tube holder that prevents the tube from being moved and/or damaged by a patient's bite is desirable. The inventors also have recognized a need for securing methods of the endotracheal tube holder to the patient that do not require two or more hands. The inventors have further recognized the desirability of an endotracheal tube holder that is adaptable to accommodate and secure medical tubes of wide range of sizes, including the Supraglottic tubes. The inventors have also recognized that it may be advantageous for an endotracheal tube holder to have an auxiliary tube holder that prevents the auxiliary tube from interfering with the securing and maintenance procedures of an endotracheal tube, and that does not limit the positioning of the auxiliary tube with respect to the endotracheal tube holder during deployment.
One embodiment consistent with the present disclosure includes an endotracheal tube holder. The endotracheal tube holder includes an elongated body portion and a tube-grasping portion. The tube-grasping portion includes a tube clamp having a bite-block portion, a tube-securing portion, and at least one channel separating the bite-block portion from the tube-securing portion. The tube-securing portion further includes a locking assembly and the tube-grasping portion further includes at least one hinge.
In certain embodiments of the present disclosure, the endotracheal tube holder includes at least one arm connecting the tube-grasping portion to the body portion. The body portion may further include a reinforcing rib extending along a longitudinal axis of the body portion and connected to the arm. In certain embodiments, the reinforcing rib may be further connected to a base member of the locking assembly.
In certain embodiments of the present disclosure, the reinforcing rib may further include a finger rest that provides leverage for closing the locking assembly.
In certain embodiments of the present disclosure, the tube clamp includes an upper contact member and a lower contact member pivotably connected via the at least one hinge. In some embodiments, a first hinge connects the upper contact member and the lower contact member of the tube-securing portion, and a second hinge connects the upper contact member and the lower contact member of the bite-block portion.
In certain embodiments of the present disclosure, the tube-securing portion includes a plurality of teeth on the interior sides of the upper contact member and lower contact member to secure a tube therebetween. The shapes of the upper contact member and the lower contact member may be partial elliptic cylindrical forms.
In certain embodiments of the present disclosure, at least a part of the interior sides of the upper contact member and/or lower contact member may provide a frictional and/or adhesive surface to increase a gripping force to secure a tube therebetween.
In certain embodiments of the present disclosure, the locking assembly includes a base member and a movable member having a plurality of ratcheting teeth, and the base member is connected to the body portion while the movable member is connected to the tube-securing portion. The base member may operatively latch to the movable member via the plurality of ratcheting teeth.
In certain embodiments of the present disclosure, the body portion includes two widened distal portions at opposite ends for lying against the face of a patient. Moreover, in certain embodiments, at least one of the widened distal portions may include an auxiliary tube holder. In some embodiments, both widened distal portions may include the auxiliary tube holder. In certain embodiments, the auxiliary tube holder may be positioned away from the top and/or bottom edges of the body portion. In certain embodiments, the auxiliary tube holder comprises a notch and orients an auxiliary tube along a longitudinal axis of the body portion.
In certain embodiments of the present disclosure, at least one of the distal portions of an endotracheal tube holder includes a band-locking cleat that secures the endotracheal tube holder to the face of a patient. In certain embodiments, the band-locking cleat includes a first opening having a band-receiving region that receives a band and a band-securing region that friction-fits the band, and a second opening that receives the band from the band-securing region of the first opening. The band may be tightened or loosened around the patient by moving (e.g. pulling) the band through the first opening. In certain embodiments, a channel breaks the second opening to an edge of the distal portion so that the band can be moved into or removed out of the second opening via the channel. In certain embodiments, the band may be secured by moving the band from the band-securing region into the second opening via the channel and released by first removing the band away from the second opening via the channel and then moving the band from the band-securing region to the band-receiving region. In certain embodiments, both of the distal portions have the band-locking cleat. In some embodiments, one distal portion has the band-locking cleat and the other distal portion has the band permanently attached, or alternatively attached via some other mechanism.
In certain embodiments of the present disclosure, the body portion further includes more than two pad regions on a patient-facing side of the body portion. In certain embodiments, the pad regions may be discretely or continuously distributed on the body portion.
Another embodiment consistent with the present disclosure is a device including a band-locking cleat for securing a device to an object or a person. The band-locking cleat includes a first opening having a band-receiving region that receives a band and a band-securing region that friction-fits the band and a second opening that receives the band from the band-securing region of the first opening. In certain embodiments, the band can move through the first opening, and a channel breaks the second opening to an edge of the device so that the band can be moved into or removed out of the second opening via the channel. In certain embodiments, the band may be secured by moving the band from the band-securing region into the second opening via the channel and released by first removing the band away from the second opening via the channel and then moving the band from the band-securing region to the band-receiving region of the first opening.
Another embodiment consistent with the present disclosure includes a method for providing a device having at least one band-locking cleat. The band-locking cleat may include a first opening comprising a band-receiving region that receives a band and a band-securing region that friction-fits the band, and a second opening that receives the band from the band-securing region of the first opening. In certain embodiments, the band can move through the first opening and a channel breaks the second opening to an edge of the device so that the band can be moved into or removed out of the second opening via the channel. Further, in certain embodiments, the band is pre-threaded through the first opening and placed within the band-securing region.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary embodiments consistent with the principles of the present disclosure.
Reference will now be made in detail to the present exemplary embodiments, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
The present disclosure provides endotracheal tube holders that will secure and hold the position of an endotracheal tube to a patient.
The tube-grasping portion 200 allows secure attachment of an endotracheal tube, thereby preventing unintended movement or dislodgement and can include a variety of different configurations. As shown in
As shown in
As discussed above and shown in
In some embodiments, as shown in
Other tube locking mechanisms may be used in conjunction with the body portion 110 and the tube clamp 210. For example, the tube-grasping portion 200 can include non-rigid closures, such as a flexible band, including VELCRO®. Alternatively, the tube-grasping portion 200 can simply include a flat or curved protrusion to which tape or other connecting materials can be applied. For example, in one embodiment, the tube clamp 210 can receive an endotracheal tube and be closed by using tapes, adhesives, a rigid cap, or other connectors. In some embodiments, the endotracheal tube holder 100 can include a system for adjustably securing the tube-grasping portion 200 to the body portion 110. For example, the elongated body portion 110 may include an elongated opening (not shown) that provides a track along which the tube-grasping portion 200 can be moved to adjust the position of an endotracheal tube along the longitudinal axis of the body portion 110.
As shown in
In some embodiments, at least a part of the interior sides of the upper contact member 215 and/or lower contact member 216 may have a frictional and/or adhesive surface to increase a gripping force for holding an endotracheal tube in place, thereby reducing or preventing movement or sliding of the endotracheal tube by a patient's bite and/or movement. The frictional and/or adhesive surface may be provided in one or more ways. For example, the tube clamp 210 may include a coating or a layer of material (not shown) on the interior sides of the upper contact member 215 and/or lower contact member 216. The coating or layer of material may be made of at least one rubbery, foamy, gummy, and/or adhesive material that have a predetermined frictional and/or adhesive surface texture, thereby increasing the force for gripping an endotracheal tube by the tube clamp 210. Additionally or alternatively, the material of the tube clamp 210 may be injection molded with the rubbery, foamy, gummy, and/or adhesive material such that at least a part of the interior sides of the upper contact member 215 and/or lower contact member 216 may have a frictional and/or adhesive surface to reduce potential movement of the endotracheal tube. The frictional and/or adhesive surface can be provided at either or both of the interior sides of the tube-securing portion 212 and the bite-block portion 211 of the tube clamp 210. In some embodiments, the rubbery, foamy, gummy, and/or adhesive material may be selected from silicon, latex, other suitable polymeric materials, or a combination thereof.
The body portion 110 and the tube-grasping portion 200 can be formed from a variety of different materials, such as FDA-approved high density medical grade polyethylene. In some embodiments, the body portion 110 is formed from a rigid material selected to maintain its curved shape during use. The rigid material may have a curvature selected to conform to the shape of a typical patient's face to allow comfortable placement of the endotracheal tube holder. In some embodiments the body portion 110 is formed from a flexible material to conform to the shape of a patient's face to allow comfortable placement of the endotracheal tube holder 100.
The body portion 110 can also include additional components that allow comfortable attachment of the endotracheal tube holder 100 to a patient. For example, as shown in
The body portion 110 can further include a securing portion to attach the endotracheal tube holder 100 to a patient. For example, one of the distal portions can include a band-locking cleat 320 that allows for securing the body portion 110 to the patient. The band-locking cleat 320 includes a first opening 330 having a band-receiving region 331 that receives a band and a band-securing region 332 that friction-fits the band, and a second opening 340 that receives the band from the band-securing region 332 of the first opening 330. The band may be tightened or loosened around the patient by moving the band through the first opening 330. In certain embodiments, a channel 341 breaks the second opening 340 to an edge of the distal portion 300 so that the band can be moved into or removed out of the second opening 340 via the channel 341. The band may be secured by moving the band from the band-securing region 332 into the second opening 340 via the channel 341 and released by first removing the band away from the second opening 340 via the channel 341 and further moving the band from the band-securing region 332 to the band-receiving region 331. Both of the distal portions 300 may have the band-locking cleat 320, or alternatively, one distal portion may have the band-locking cleat 320 and the other distal portion may have the band permanently attached. The band can be a flexible elastic band, or can be made from a resilient fabric, strap, or cloth, such as polypropylene fiber cloth or a nylon woven braid. In some embodiments, the band may have a thickness of about 2 mm. The band allows a securing member 321 near the band-securing region 332 to dig into and locks the band from moving. The band-locking cleat 320 allows easy tightening, loosening, and securing of the band by using just one hand of a user or a medical practitioner, relieving the other hand for holding a device, such as the intubated endotracheal tube and/or an endotracheal tube holder. This easily operable band-locking cleat 320 thus allows time and labor efficient practice of securing a device to a patient, such as an endotracheal tube holder, especially desirable under emergency or “field” settings, where easy and quick securing mechanisms are crucial for life saving.
As shown in
Endotracheal tube holders consistent with the present disclosure prevent an endotracheal tube from being moved by a patient's bite and/or movement. Endotracheal tube holders consistent with the present disclosure are advantageously designed to adaptively accommodate and secure medical tubes of wide range of sizes, including the Supraglottic tubes, which minimize airway trauma while maximizing ventilation and allow passage into the esophagus and/or the stomach. Endotracheal tube holders consistent with the present disclosure may also have at least one auxiliary tube holder advantageously designed that conveniently secures an auxiliary tube coming out from any edge of the endotracheal tube holder and prevents the auxiliary tube from interfering with the securing and maintenance procedures of the endotracheal tube. Endotracheal tube holders consistent with the present disclosure may be made as a single piece, avoiding time-consuming assembly and/or disassembly of individual pieces in emergency medical situations. The band-locking cleat and/or the locking assembly consistent with the present disclosure advantageously enables one user or one medical practitioner to secure the endotracheal tube holder to the patient with only two hands, one for holding the endotracheal tube and/or the endotracheal tube holder while the other for tightening and securing.
Securing methods for providing a device to an object or a patient consistent with the present disclosure enable easily operable and time-efficient attachment and securing of the device. Securing methods consistent with the present disclosure provide a device preferably having at least one band-locking cleat that conveniently attaches and secures the device by allowing pulling and securing a strap or band. The band-locking cleat of the securing methods consistent with the present disclosure preferably has a first opening comprising a band-receiving region that receives the band and a band-securing region that friction-fits the band, and a second opening that receives the band from the band-securing region of the first opening. Securing methods consistent with the present disclosure thus allow the band to be moved or pulled with one hand through the first opening and be moved into or removed out of the second opening via a channel that is advantageously designed to break the second opening to an edge of the device. Moreover, securing methods consistent with the present disclosure preferably have the band pre-threaded through the first opening and placed within the band-securing region to be ready for a user or a medical practitioner to easily provide and secure the device with only two hands, one for holding the device while the other for tightening and securing.
It will be apparent to those skilled in the art that additional various modifications and variations can be made consistent with the present disclosure. Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice of the disclosure. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the disclosure being indicated by the following claims.
Number | Date | Country | |
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62173561 | Jun 2015 | US |