Patent Application
20230256184
The present invention relates to medical equipment in the field of airway management, cardiac diagnostic procedures, upper gastrointestinal diagnostic procedures, and pancreatic diagnostic procedures.
During respiratory and endoscopic procedures, the endoscope or similar equipment is frequently damaged by the patient's dentition. The patient's lip, teeth, and tongue are often damaged by the manipulation of endoscopic equipment. A bite block prevents the patient from biting on respiratory or endoscopic equipment and/or causing injury to the patient. The currently available bite block is a closed ring of hard plastic material and requires the scope or respiratory equipment to be placed through the bite block before the initiation of the procedure.
Safe intubation of the esophagus is a critical step to perform the procedure and ideally once the endoscope is inserted in the esophagus it should only be removed at the end of procedure. The passage of the scope into the esophagus can be difficult in certain patients and the bite block must be placed in the patients mouth before the insertion of the scope. If the endoscope is inserted and the proceduralist forgets to place the bite block the scope is totally removed and the procedure repeated with the bite block in place. Multiple attempts can potentially cause injury of oral cavity pharyngeal and laryngeal structures.
Certain endoscope apparatus is equipped with various functionalities such as camera, light source, biopsy capabilities, ultrasound transducers, electromagnetic tracking features, etc. Scopes can be expensive and costly to repair, thus damage prevention is beneficial and cost effective. In certain circumstances, a bite block is necessary where patients have altered mental status; a partial level of consciousness such as emerging from general anesthesia, partially sedated in the intensive care unit; seizures; or uncooperative behavior.
In patients requiring invasive mechanical ventilation, the endotracheal tube provides a direct connection between the ventilator circuit and patients trachea and lungs. The occlusion of the endotracheal tube can occur secondary to the biting of a patient bite or kinking on the tube on dentition. The disconnection or impedance of the endotracheal tube should be avoided to prevent deflation of the lungs and aerosolization of infectious droplets. The currently available bite block requires disconnection of the endotracheal circuit for removal.
During general anesthesia, the disconnection of the endotracheal tube from the respiratory circuit can cause spilling of anesthetic gases in the operating room environment. When emerging patients from general anesthesia, biting the endotracheal tube is a common event in superficial stages of anesthesia. The occlusion of the endotracheal tube is associated with the extremely negative pressures generated by the attempt to breath and it causes alveolar damage; a complication known as negative pressure pulmonary edema. This complication can be avoided by using a bite block.
Bite blocks were designed for easy insertion and manipulation of an endoscope in short procedures such as upper endoscopy, therefore they have a large profile and may not fit in patients with a small mouth. Bite blocks may also be necessary for long periods of time. A regular bite block may not fit in a small mouth opening and if the placement is too tight it may result in unwanted pressure injury to the teeth, gum, or lip. Moreover, when patients are intubated a good part of the oral cavity is occupied by the endotracheal tube. A bite block with a smaller profile is useful when patients are intubated and require additional endoscopy. In that circumstance it is difficult to use the regular bite blocks.
The present invention provides a solution for the above-described problems and improves the functionality of bite block equipment. The device described herein is a bite block that can be interchanged from an open to a close configuration and vice-versa allowing the bite block to positioned around equipment after intubation or insertion through a patient's oral cavity. The bite block described herein can be placed around the endoscopic or respiratory equipment either before or after the insertion of the scope and does not requiring disconnection of the endotracheal tube during placement or positioning of the device.
Certain embodiments are directed to a bite block comprising a complementary first half component and second half component. The device being configured to fold along a hinge to bring the two half components together to form an operable bite block that can be reversible locked in an operable configuration during use. Each half component having a front portion configured to be inserted in the oral cavity of a subject during use, a back portion configured to be external to the subject during use, a hinge side with a hinge side interface surface, a lock side with a lock side interface surface, a concave semicircular interior surface positioned between the hinge side interface and the lock side interface, and an external surface. The first and second half component being connected by a hinge positioned on the hinge side of each component. The hinge can be two-piece interlocking hinge or a flexible portion integrated with both half components. In certain aspects the hinge in a portion of plastic that can be bent over on itself. The lock side of each half component has a portion of a complementary lock portion. The lock portion can be a male, female, or can have both a male and female portion that complements a male, female, or a male and female portion on the second lock side portion. The complementary half components can be pivoted at the hinge to bring the lock components in contact and the interior surfaces in apposition forming a closed bite block having a lumen from front to back.
In certain aspects, the bite block is a one-piece construction. The bite block can be made of a plastic material.
The bite block can have complementary interlocks positioned on the hinge side interface. In certain aspects the interlocks can be a peg and hole interlock configured, for example, to assist in alignment of the two half components.
The bite block is configured to be closed by manual approximation of the lock sides of each half of the device. The bite block is configured to be opened by manual separation of the lock sides of each half of the device. The bite block is configured to provide an audible click or snap sound when the device is appropriately engaged in the closed position.
The bite block can have a rubberized external surface or rubberized portions of the external surface to provide cushion and protect dentition from pressure damage during use.
In certain aspects, the bite block forms an external lip having a larger diameter relative to the front portion.
Other embodiments of the invention are discussed throughout this application. Any embodiment discussed with respect to one aspect of the invention applies to other aspects of the invention as well and vice versa. Each embodiment described herein is understood to be embodiments of the invention that are applicable to all aspects of the invention. It is contemplated that any embodiment discussed herein can be implemented with respect to any method or composition of the invention, and vice versa. Furthermore, compositions and kits of the invention can be used to achieve methods of the invention.
The use of the word “a” or “an” when used in conjunction with the term “comprising” in the claims and/or the specification may mean “one,” but it is also consistent with the meaning of “one or more,” “at least one,” and “one or more than one.”
Throughout this application, the term “about” is used to indicate that a value includes the standard deviation of error for the device or method being employed to determine the value.
The use of the term “or” in the claims is used to mean “and/or” unless explicitly indicated to refer to alternatives only or the alternatives are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and “and/or.”
As used in this specification and claim(s), the words “comprising” (and any form of comprising, such as “comprise” and “comprises”), “having” (and any form of having, such as “have” and “has”), “including” (and any form of including, such as “includes” and “include”) or “containing” (and any form of containing, such as “contains” and “contain”) are inclusive or open-ended and do not exclude additional, unrecited elements or method steps.
As used herein, the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having,” “contains”, “containing,” “characterized by” or any other variation thereof, are intended to encompass a non-exclusive inclusion, subject to any limitation explicitly indicated otherwise, of the recited components. For example, a chemical composition and/or method that “comprises” a list of elements (e.g., components or features or steps) is not necessarily limited to only those elements (or components or features or steps), but may include other elements (or components or features or steps) not expressly listed or inherent to the chemical composition and/or method.
As used herein, the transitional phrases “consists of” and “consisting of” exclude any element, step, or component not specified. For example, “consists of” or “consisting of” used in a claim would limit the claim to the components, materials or steps specifically recited in the claim except for impurities ordinarily associated therewith (i.e., impurities within a given component). When the phrase “consists of” or “consisting of” appears in a clause of the body of a claim, rather than immediately following the preamble, the phrase “consists of” or “consisting of” limits only the elements (or components or steps) set forth in that clause; other elements (or components) are not excluded from the claim as a whole.
As used herein, the transitional phrases “consists essentially of” and “consisting essentially of” are used to define a chemical composition and/or method that includes materials, steps, features, components, or elements, in addition to those literally disclosed, provided that these additional materials, steps, features, components, or elements do not materially affect the basic and novel characteristic(s) of the claimed invention. The term “consisting essentially of” occupies a middle ground between “comprising” and “consisting of”.
Other objects, features and advantages of the present invention will become apparent from the following detailed description. It should be understood, however, that the detailed description and the specific examples, while indicating specific embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.
The following drawings form part of the present specification and are included to further demonstrate certain aspects of the present invention. The invention may be better understood by reference to one or more of these drawings in combination with the detailed description of the specification embodiments presented herein.
The following discussion is directed to various embodiments of the invention. The term “invention” is not intended to refer to any particular embodiment or otherwise limit the scope of the disclosure. Although one or more of these embodiments may be preferred, the embodiments disclosed should not be interpreted, or otherwise used, as limiting the scope of the disclosure, including the claims. In addition, one skilled in the art will understand that the following description has broad application, and the discussion of any embodiment is meant only to be exemplary of that embodiment, and not intended to intimate that the scope of the disclosure, including the claims, is limited to that embodiment.
The bite block described herein can has additional functional features and the same or equivalent structural strength compared with currently available bite blocks.
The hinge between the two “C” halves keeps the parts always connected and aligned during the transition from open to closed configuration and vice versa. The hinge can be intergarl to the manufacture of a one piece device or can be permanently attached to both halves of the device. In the close position the halves form a lumen, i.e., make a full ring, that provides the same functionality of a regular bite block, but allow the optional removal of the device without removing or detaching a medical device associated with the bite block. The lumen cross-section can be a circle, oval, ellipse, or other geometry.
In certain aspects, interlock bosses 3 and respective debosses 4 are present on both surfaces of the “C” halves interface (interface surfaces) to prevent the two parts from sliding when under pressure and to provide continuity of the structural strength to sustain pressure.
The locking mechanism 2 can be a snap lock that keeps the bite block in close position preventing it from accidental opening. In certain aspects the lock provides an audible “click”, indicating the close configuration was achieved. The lock can be disengaged or opened and the device returned to open configuration.
One advantage of the device described herein is the hinged bite block can be placed on a scope or an endotracheal tube after placement. There is no need for removal and reinsertion of the scopes, there is no need for disconnection of endotracheal tubes and interruption of mechanical ventilation. The hinged bite block is placed around the tube, locked, and adjusted in the patient's mouth. Compared to the regular bite blocks the hinge block has a smaller profile specifically designed for long stay without damage to the oral cavity.
In certain aspects the bite block has a soft cushion layer or pad on the surface that directly contacts the front upper and lower teeth. This cushion layer is made of rubberized material such as thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), or similar material.
In certain embodiments the bite block described herein is one single plastic part with plastic design features that provide functionality to the device. The living hinge 1 allows the transition in configuration from open to close position and vice-versa. The hinge is made of a thin amount of material that allows flexibility but tensile strength to prevent breakage.
The snap locks 2 keep the bite block in close configuration and prevent it from spontaneously opening but allows manual opening and closing.
The bossing interlocks 3 and debosses 4 interlocks, allows alignment and stabilization when the two halves come together from open to close configuration.
The front rim or lip 5 stabilizes the bite block between the patient's lips and prevents accidental dislodgement and migration of the bite block into the oral cavity during the manipulation of the scope. Rim 8 stabilizes the bite block between the patient's front upper and lower teeth and prevents dislodgement and external migration.
Internal surface 6 where the scope is in contact, has a smooth surface finishing to prevent friction and potential damage to the scope surfaced with multiple passes.
The external surface 7 where the patients front top and front bottom teeth will be in contact. The surface can be made of the same material or preferably with a thin layer of rubberized material.
In certain aspects the internal diameter of the device when closed is, is at least, or is about 10, 12, 14, 16, 18, 20, to 22 mm. The external diameter of the body between the lip and the rim is, is about, or is at least 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, to 27 mm. The width of the body between the rim and the lip is, is about, or is at least 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, to 27 mm. The rim can have maximum diameter of, of about, or at least 22, 23, 24, 25, 26, 27, 28, 29, 30 mm (providing a 3, 4, 5, 6, 7, to 8 mm projection from the body. The lip can have a diameter of 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37 38, 39, to 40 mm (providing for a 12, 13, 14, 15, 16, 17, to 18 mm projection from the body or the device. In certain aspects the thickness of the walls of the device are 3 to 4 mm. In certain aspects the front lip has a height of 14-16 mm, a width of 24-30 mm, thickness of 3 to 4 mm. In certain aspects the rim has a height of 4-8 mm, a width of 15 to 30 mm, and a thickness of 3-4 mm.
This Application claims priority to U.S. Provisional Application Ser. No. 63/039,567 filed Jun. 16, 2020, which is incorporated herein by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US21/37542 | 6/16/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63039567 | Jun 2020 | US |
