Tracheal Intubation Device

Abstract

To provide an everting vine robot intubation device capable of automatically and autonomously intubating the trachea and producing a lumen through which artificial ventilation may be conducted.SOLUTION: The device includes an everting primary vine robot attached to a mouthpiece, and a smaller-diameter everting intubation vine robot associated with the primary everting vine robot. The primary vine robot is shaped and sized to extend to the back of a patient's laryngopharynx when fully actuated, and the intubation vine robot is shaped and sized to extend from the primary vine robot into the patient's trachea when fully actuated.SELECTED DRAWING: Figure 1E

Description

[Technical field]

[0001] (Priority claims and citations to related applications) This application claims priority under 35 U.S.C. § 119 and any applicable statutes or treaties to earlier provisional application Ser. No. 62 / 882,239, filed Aug. 2, 2019.

[0002] (Statement of Government Interest) This invention was made with Government support under Grant No. 1637446 awarded by the National Science Foundation. The Government has certain rights in this invention.

[0003] (Field) The field of the invention includes medical devices, including, among other things, intubation devices and robotics. [Background technology]

[0004] US Patent No. 5,399,363, published on July 18, 2019, by Hawks et al. discloses a growing robot. The growing robot has a thin-walled, hollow, pressurized flexible body that extends the body by everting new wall material stored within the body from its tip, and controls the shape of the body by actively controlling the relative lengths of the wall material along opposing sides of the body. The relative lengths of the wall material along opposing sides of the body can be controlled by shortening the length of the wall material on the curved inward-facing side by using contracting artificial muscles mounted along the length of the body. It is also possible to control the relative lengths of the wall material along opposing sides of the body by extending the length of the wall material on the curved outward-facing side, releasing the contraction of the wall material, or actively softening the wall material so that the body is stretched by internal pressure. It is also possible to control the relative lengths of the wall material along opposing sides of the body by actively constraining the length of the wall material on the curved inward-facing side while allowing the curved outward wall material to lengthen.

[0005] The advance in growing robotics technology by Hawks et al. is provided in a soft robotic device with tip extensions and includes burrowing and fluid ejection for cleaning. Such soft robots can burrow into sand or soil in a manner similar to plant roots. The robot extends tip by eversion while ejecting fluid from the tip that allows it to grow underground and fluidizes the sand and soil. The advance is disclosed in PCT / US2019 / 50998, filed September 13, 2019, and in the published paper by Hawks et al., Non-Patent Document 1.

[0006] Emergency Medical Technicians (EMTs) are successful intubating in emergency situations just over 50% of the time for a variety of reasons. To achieve the high level of success realized in the hospital room requires extensive training at great cost. This presents a serious medical dilemma: how to ensure that nurses, paramedics, or EMTs can effectively provide critical care without training to anesthesiologist level. The present invention provides hospital level success with less extensive medical training, and may improve the success rate of paramedics and other personnel. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] US Patent Application Publication No. 2019 / 0217908 [Non-patent literature]

[0008] [Non-Patent Document 1] Soft Robotic Burrowing Device with Tip-Extension and Granular Fluidization Summary of the Invention [Means for solving the problem]

[0009] A preferred embodiment provides an everting vine robotic intubation device capable of automatically and autonomously intubating the trachea and creating a lumen through which artificial ventilation can be conducted, the device comprising a primary everting vine robot attached to a mouthpiece and a small diameter everting intubating vine robot associated with the primary vine robot, the primary vine robot having a shape and size such that when fully actuated, the primary vine robot extends behind the patient's larynx, and the intubating everting vine robot has a shape and size such that when fully actuated, the primary vine robot extends from the primary vine robot into the patient's trachea.

[0010] A method is provided for intubating a patient. A mouthpiece attached to an everting primary temple robot and an intubation temple robot is inserted into the patient's mouth with the primary temple robot and the intubation temple robot in an inoperative position. Fluid pressure is applied within the primary temple robot to cause it to gradually evert and extend behind the patient's larynx. Fluid pressure is applied to extend the intubation temple robot into the patient's trachea and provide a lumen from the mouthpiece to the trachea. Air or oxygen is provided into the trachea through the lumen. [Brief description of the drawings]

[0011] The invention is explained in more detail below on the basis of exemplary embodiments shown in the following drawings.

[0012] [Figure 1A] FIG. 1A is a schematic diagram of a preferred embodiment of a vine robotic intubation device in an unactuated state. [Figure 1B] FIG. 1B illustrates the vine robotic intubation device of FIG. 1A in a partially activated state. [Figure 1C] FIG. 1C illustrates the vine robotic intubation device of FIG. 1A in a partially activated state. [Figure 1D] FIG. 1D illustrates the actuation of the intubation vine of FIG. 1A, which provides a lumen through which a breathing tube passes. [Figure 1E]FIG. 1E illustrates the insertion of a breathing tube through the lumen created by the extension of the intubation vine shown in FIG. 1D. [Figure 2A] FIG. 2A is a schematic diagram of a preferred embodiment of a vine robotic intubation device in a partially activated state and a fully activated state. [Figure 2B] FIG. 2B is a schematic diagram of a preferred embodiment of a vine robotic intubation device in a partially activated state and a fully activated state. [Figure 2C] FIG. 2C is a schematic diagram of a preferred embodiment of a vine robotic intubation device in a partially activated state and a fully activated state. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] The vine robotic intubation device of the preferred embodiment comprises, and preferably consists of, a primary everting body, an intubating body, and a mouthpiece with access ports that allow fluid / pressure transfer from a regulated pressure reservoir to the bodies. When the primary everting body expands, it grows down the pharynx and carries the intubating body past the tongue and epiglottis. After the primary expansion, the intubating body is expanded to grow past the epiglottis into the trachea. This body can serve as a passageway for a semi-rigid breathing tube to initiate artificial ventilation. The overall length can be pre-determined to match different physiologies depending on, for example, the size, age, or measured physical characteristics of the patient. The preferred embodiment is inexpensive and disposable, avoiding issues with cleaning and reuse that can lead to hospital-acquired infections and other problems.

[0014] Preferred embodiments of the present invention may now be described with reference to the drawings. The drawings may include schematic representations that will be understood by those skilled in the art with general knowledge in the art and with reference to the following description. Features may be exaggerated in the drawings for emphasis and may not be drawn to scale.

[0015] The progressive states of the preferred embodiment vine robotic intubation device 10 during an intubation procedure are shown in Figures 1A-1E. Figure 1A shows the initial and non-activated state, in which a molded mouthpiece 12 is inserted into the patient's mouth 14. The mouthpiece holds the primary vine robot 16 and includes an access port 18 that allows for the transfer of fluids / pressure to the primary vine robot 16 for growing the primary vine robot 16 via eversion. The intubation vine robot 20 is carried on the exterior surface of the primary vine robot 16 and extends through the mouthpiece 10 to allow access to fluids / pressure for its sole actuation and eversion. Most of the intubation robot vine 20 is housed within the primary robot vine 16, as in FIG. 1A the primary robot vine 16 is in a fully retracted state when most of its members are everted back inwards on itself towards its center. In general, the diameter and length of both the primary robot vine and the intubation robot vine can be predefined according to the physiological type or measured physical characteristics (e.g., age, sex) of the patient to be intubated, according to physical measurements of the throat structure, etc. In practice, the practitioner can choose among available robot vine intubation devices and use a suitable size selected based on the physiology. As for the material of the primary robot vine 16 and the intubation robot vine 20, biocompatible plastics are preferred. The stiffness is lower than the radial stiffness so that the body lengthens instead of bulging outwards under pressure. The connection with the mouthpiece can be compatible with current medical technology, e.g., Luer lock, even considering the expansion. The device is preferably sterilized and packaged for a single use, and the packaging and device may include markings to ensure proper use by the physician.

[0016] The mouthpiece 12 is preferably made of a biocompatible plastic or hardened rubber compound and is shaped to match the general anatomy of the human face and mouth, with a protrusion for insertion into the mouth to depress the tongue, and a recess into which teeth can fit to hold the device in the mouth and establish a standard "zero" reference point from which the extension of the intubation vine 20 can be determined. Suitable materials include medical grade silicone, polyurethane, or polyethylene. The mouthpiece is sized according to anatomical characteristics as described above with respect to the vine. The mouthpiece 12 may contain mechanical components (e.g., buttons) to enable actuation and an indicator to show whether it has been used. Rigidity is achieved by expansion. The mouthpiece in a preferred embodiment may be connected to and / or include a pressure reservoir, an actuation mechanism to initiate intubation, and mechanical and electrical elements to actuate and control the two vines. The housing also contains a passageway through which a semi-rigid breathing tube passes through the secondary body and down into the trachea. The control may include optical, ultrasonic, magnetic, or other feedback.

[0017] The primary crane robot 16 is a larger crane robot that delivers a smaller intubation crane robot 20 to the rear of the larynx while projecting the jaw forward to further expose the trachea. The diameter of the primary crane robot 16 is set to lift the mandible and project forward and downward while filling the oral cavity and oropharynx. Fluid, e.g., air, is delivered through port 18 with enough pressure to slowly inflate and invert the primary crane robot 16 until it reaches the rear of the larynx. Once at that point, the smaller intubation crane robot 20 is actuated by fluid pressure from its proximal end that extends through the mouthpiece. The primary crane robot 16 can be shaped into a predefined non-linear shape (when extended) and can have members at specific locations to provide specific pressure points to project the mandible, lift the epiglottis, and expose the trachea. Methods for shaping materials and creating solidity in specific areas are disclosed in U.S. Patent Application Publication No. 2019 / 0217908 by Hawkes et al.

[0018] The intubation robot vine 20 is a lumen generating vine that grows from the tip of the primary robot vine and reaches the trachea beyond the vestibular folds. By generating a lumen, the intubation robot vine terminates distally with an open or tearable or pierceable temporarily sealed distal end to provide an open lumen for passage and from its proximal opening to its distal opening after eversion is completed. The distal end may be open, for example, may include a perforated seal. Another option is a resilient distal end that can be pierced by the breathing tube. This type of distal end provides feedback to the practitioner as to when the breathing tube will pierce the distal end of the intubation robot vine. The intubation robot vine 20 is preferably designed to operate in a Seldinger-type manner to access the trachea in situations where the vocal cords are partially closed. The vines have been shown to be able to pass through openings smaller than the diameter of their bodies. With the appropriate flexible size, the intubation robot vine 20 can pass through a partially closed vocal cord, regardless of the size of the opening, and larger tubes can pass through this lumen by eliminating the relative motion between the stiffened ventilation tube and the vocal cord. The intubation robot vine 20 may also be designed in such a way that it creates a passage for artificial ventilation, for example by stiffening or pulling itself through a semi-stiffened tube during growth. By attaching a stiffening tube to the open end of the intubation body, the expansion acts as a pulling force so that the intubation body everts. This allows the stiffening tube to be automatically delivered. Another option is to introduce a biocompatible self-hardening material into the base structure of the body of the vine, allowing the device to harden in the body and form a rigid lumen by itself. Although one intubation robot vine 20 is illustrated, the primary intubation robot vine 20 is capable of carrying multiple intubation bodies (e.g., a controlled intubation robot and an uncontrolled / passive simple lumen) intended to increase the robustness of the device as well as multiple potential configurations of each of the multiple intubation bodies.

[0019] FIG 1B shows the primary robot vine 16 in an actuated state. This stage begins in two sub-steps: the primary robot vine 16 expands and grows away from the mouthpiece 12 toward the patient's throat. FIG 1C shows the primary robot vine 16 fully extended into the larynx. At this point, the intubation robot vine 20 is in the position to expand and grow. The intubation robot vine 20 can be pre-shaped to approximate the average anatomical structure.

[0020] FIG. 1D illustrates the growth of the intubation robot vine 20 into the trachea. As the intubation robot vine 20 grows, a predefined shape is preferably generated with the ends directed forward toward the trachea. The intubation robot vine 20 may be preformed to have one or two curves 22 (two are shown in FIG. 1D and FIG. 1E). The curves provide the predefined shape. As discussed in U.S. Patent Application Publication No. 2019 / 0217908 to Hawks et al. and in the background of this application, the curves may be provided in different ways. Different ways include controlling the relative lengths of the walls of the intubation robot vine 20 on different sides. The open distal end 24 of the intubation body allows for the creation of a lumen through which a semi-rigid breathing tube can pass.

[0021] FIG. 1E shows the passage of the breathing tube 26, first through the mouthpiece 12 and second through the lumen provided by the extension of the intubation vine 20. This passage allows the breathing tube to easily pass through the lumen and enter the patient's trachea. At this point, the device 10 can be removed from the patient and artificial ventilation can be initiated. Another option instead of a tube is to include a valve to implement PEEP (positive-end expiatory pressure), which could be used instead of a breathing tube. If used, it is important to ensure that sufficient pressure is maintained so that the device does not collapse on itself during exhalation. The breathing tube adds an additional component and step. However, it ensures easy and reliable intubation. It may also reduce the cost of the intubation vine device, since it only needs to be designed to deliver, instead of support the breathing cycle.

[0022] 2A-2C show another preferred embodiment of the vine robot intubation device 30. Common components shown in FIGS. 1A-1E are assigned common reference numbers. Operation is similar to device 10 of FIGS. 1A-1E. In device 30, intubation vine robot 32 is integrally formed with primary vine robot 34 as a branch extending from the side wall of primary vine robot 34. Intubation vine robot 32 includes preformed curved section 36 as in FIG. 1E to assist in adjusting the passage of air tube through the lumen defined thereby. A breathing tube may be used. Alternatively, intubation vine robot and primary vine robot 34 incorporate a flexible, self-expanding material, such as Nitinol, at the distal opening and in several locations to maintain the breathing lumen throughout the entire breathing cycle. The expansion overcomes the force of the self-expanding material during insertion, and the self-expanding material maintains the opening. By having the intubating vine robot 32 be a branch of the primary vine robot 34, it can be actuated via the same pressure source and lumen so that the ventilator can simply pressurize the vine for deployment and then continue ventilation in the minimum number of steps possible. Preferably, as shown in FIG. 2C, the primary vine robot 34 has a length such that it can extend slightly into the esophagus. This helps both to stabilize the device 30 and to create a seal to prevent aspiration, similar to a laryngeal mask airway (LMA).

[0023] While particular embodiments of the present invention have been illustrated and described, it should be understood that other modifications, substitutions, and alternatives are apparent to those of ordinary skill in the art, and such modifications, substitutions, and alternatives can be made without departing from the spirit and scope of the present invention, which should be determined from the appended claims.

[0024] Various configurations of the invention are set forth in the following claims.

[0025] (Additional Note) (Appendix 1) 1. A vine robotic tracheal intubation device, comprising: an everting primary crane robot attached to a mouthpiece; an everting small diameter intubating robot vine associated with the primary everting robot vine; Equipped with the primary crane robot is shaped and sized to extend behind the patient's larynx when fully actuated, and the intubation everting crane robot is shaped and sized to extend from the primary crane robot into the patient's trachea when fully actuated, thereby providing a lumen from the mouthpiece to the patient's trachea by the device. A vine-like robotic tracheal intubation device.

[0026] (Appendix 2) The diameter of the primary crane-like robot is set to fill the oral cavity and oropharynx while lifting the mandible and projecting it forward and downward. Appendix 1: Vine-like robotic tracheal intubation device.

[0027] (Appendix 3) the intubation vine comprises a pre-curved section configured to position and orient the lumen within the trachea; Appendix 1: Vine-like robotic tracheal intubation device.

[0028] (Appendix 4) The intubation robot vine is carried on an exterior surface of the primary robot vine. Appendix 3: A vine-like robotic tracheal intubation device.

[0029] (Appendix 5) the intubation vine robot sizes the lumen to allow a breathing tube to pass therethrough; Appendix 4: A vine-like robotic tracheal intubation device.

[0030] (Appendix 6) the mouthpiece defines an access port to allow expansion of the primary vine robot; Appendix 4: A vine-like robotic tracheal intubation device.

[0031] (Appendix 7) The intubation vine extends through the mouthpiece. Appendix 6: A vine-like robotic tracheal intubation device.

[0032] (Appendix 8) the intubation vine robot is integrally formed with the primary vine robot and configured to form a branch from the primary vine robot upon extension; Appendix 3: A vine-like robotic tracheal intubation device.

[0033] (Appendix 9) the mouthpiece defines an access port for allowing inflation of both the primary vine and the intubation vine from a single pressure source. Appendix 8: Vine-like robotic tracheal intubation device.

[0034] (Appendix 10) the lumen is defined by both the primary robot vine and the intubation robot vine when extended; Appendix 8: Vine-like robotic tracheal intubation device.

[0035] (Appendix 11) the primary robot crane having a predetermined non-linear shape when extended; Appendix 1: Vine-like robotic tracheal intubation device.

[0036] (Appendix 12) the predetermined non-linear shape is configured to create pressure points to protrude the mandible, lift the epiglottis, and expose the trachea. Appendix 11: A vine-like robotic tracheal intubation device.

[0037] (Appendix 13) the distal end of the intubation vine comprises a flexible, self-expanding material; Appendix 1: Vine-like robotic tracheal intubation device.

[0038] (Appendix 14) the flexible, self-expanding material being Nitinol; Appendix 13: A vine-like robotic tracheal intubation device.

[0039] (Appendix 15) 1. A method of intubating a patient, comprising: inserting a mouthpiece attached to an everting primary vine robot and an intubation vine robot into the patient's mouth while both the primary vine robot and the intubation vine robot are in an inoperative position; applying fluid pressure within the primary crane to gradually evert and extend it behind the larynx of the patient; applying fluid pressure to extend the intubation vine into the patient's trachea and provide a lumen from the mouthpiece to the trachea; providing air or oxygen into the trachea through said lumen; Including, method.

[0040] (Appendix 16) providing includes passing a respiratory tube through the intubation vine and providing the air or oxygen through the respiratory tube. Method of Appendix 15.

[0041] (Appendix 17) removing the mouthpiece, the primary robot vine, and the intubation robot vine while leaving the respiratory tube in the position prior to providing. Method of Appendix 16.

[0042] (Appendix 18) said providing includes passing said air or oxygen through said lumens defined by both said primary vine and said intubation vine. Method of Appendix 16.

Claims

1. a mouthpiece configured to be inserted into the subject; a primary everting crane-like robot coupled to the mouthpiece and configured to extend from the mouthpiece to reach a lower posterior portion of the subject's pharynx when inserted into the subject during actuation; A secondary eversion crane robot connected to the primary eversion crane robot, the secondary eversion crane robot extending from the side wall of the primary eversion crane robot when activated and reaching the trachea of ​​the subject, or the secondary eversion crane robot contacting the side wall of the primary eversion crane robot when not activated and its tip being in contact with the tip of the primary eversion crane robot, and when activated, the tip leaving the tip of the primary eversion crane robot and extending further beyond it to reach the trachea of ​​the subject; A tracheal intubation device comprising: When the primary everting crane robot and the secondary everting crane robot are actuated, the mouthpiece, the primary everting crane robot, and the secondary everting crane robot provide an airflow lumen from outside the subject to the trachea of ​​the subject. Tracheal intubation device.

2. When the primary eversion crane robot is operated, the primary eversion crane robot assumes a predetermined non-linear shape.

2. The tracheal intubation device of claim 1.

3. the predetermined non-linear shape is configured to create one or more pressure points that cause the subject's mandible to protrude, the subject's epiglottis to elevate, or the subject's trachea to be exposed.

3. A tracheal intubation device as claimed in claim 2.

4. The primary eversion crane robot has a length that allows the primary eversion crane robot to reach the esophagus of the subject when the primary eversion crane robot is activated.

2. The tracheal intubation device of claim 1.

5. The secondary eversion crane robot is integrally and continuously configured with the primary eversion crane robot.

2. The tracheal intubation device of claim 1.

6. The secondary eversion vine robot is a branch of the primary eversion vine robot.

2. The tracheal intubation device of claim 1.

7. The secondary eversion crane robot is at least partially supported on an outer surface of the primary eversion crane robot.

2. The tracheal intubation device of claim 1.

8. the secondary everting robot crane includes a pre-bent section that is formed as the secondary everting robot crane moves to determine the location and direction of the airflow lumen entering the trachea; 2. The tracheal intubation device of claim 1.

9. the mouthpiece includes an access port that allows inflation of both the primary everting crane robot and the secondary everting crane robot with a single pressure source; 2. The tracheal intubation device of claim 1.

10. The airflow lumen is configured to allow a respiratory tube to pass therethrough.

2. The tracheal intubation device of claim 1.

11. Either the primary everting crane robot or the secondary everting crane robot or both include a flexible self-extending material; 2. The tracheal intubation device of claim 1.

12. the flexible, self-expanding material comprises Nitinol; 12. A tracheal intubation device as claimed in claim 11.

13. Either the primary eversion crane robot or the secondary eversion crane robot, or both, are made of a biocompatible plastic.

2. The tracheal intubation device of claim 1.

14. The biocompatible plastic is selected from the group consisting of silicone, polyurethane, polyethylene, or composites thereof.

14. A tracheal intubation device as claimed in claim 13.

15. Either the primary everting crane robot or the secondary everting crane robot, or both, have a predetermined diameter or length based on the physiological type of the subject or a measured physical characteristic of the subject.

2. The tracheal intubation device of claim 1.

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