CA2816265A1 - Smartphone enabled bougie with handle adjustability - Google Patents
Smartphone enabled bougie with handle adjustability Download PDFInfo
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- CA2816265A1 CA2816265A1 CA 2816265 CA2816265A CA2816265A1 CA 2816265 A1 CA2816265 A1 CA 2816265A1 CA 2816265 CA2816265 CA 2816265 CA 2816265 A CA2816265 A CA 2816265A CA 2816265 A1 CA2816265 A1 CA 2816265A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00064—Constructional details of the endoscope body
- A61B1/00105—Constructional details of the endoscope body characterised by modular construction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/267—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the respiratory tract, e.g. laryngoscopes, bronchoscopes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0488—Mouthpieces; Means for guiding, securing or introducing the tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
- A61M2205/502—User interfaces, e.g. screens or keyboards
- A61M2205/505—Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
- A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
-
- H—ELECTRICITY
- H04—ELECTRIC COMMUNICATION TECHNIQUE
- H04M—TELEPHONIC COMMUNICATION
- H04M1/00—Substation equipment, e.g. for use by subscribers
- H04M1/02—Constructional features of telephone sets
- H04M1/04—Supports for telephone transmitters or receivers
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- Surgery (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
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- Heart & Thoracic Surgery (AREA)
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- Otolaryngology (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Optics & Photonics (AREA)
- Pathology (AREA)
- Emergency Medicine (AREA)
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- Hematology (AREA)
- Anesthesiology (AREA)
- Endoscopes (AREA)
Abstract
The claimed invention assists in endotracheal intubation of patients both orally and nasally. This is a bougie with handle adjustability in which a smartphone is used as displaying, imaging and recording unit. In addition to providing direct and digital view of the patients airway anatomy, this unit enables the user to store the images and video of intubation procedure in the smartphone memory for consultation, research and teaching purposes. The claimed device has a bending mechanism which gives the stylet or bougie the controllability of a flexible fiberoptic bronchoscope, while it has less weight;
less complexity: and it has much less price compared to a flexible fiberoptic bronchoscope. It can be used for both out of hospital case scenarios (e.g., ambulances and first responders in fire department vehicles) and intra-hospital cases (e.g., emergency rooms, ICU and operation rooms).
less complexity: and it has much less price compared to a flexible fiberoptic bronchoscope. It can be used for both out of hospital case scenarios (e.g., ambulances and first responders in fire department vehicles) and intra-hospital cases (e.g., emergency rooms, ICU and operation rooms).
Description
Smartphone Enabled Bougie with Handle Adjustability 2 This invention delivers a srnartphone enabled bougie with handle adjustability which assists in endotra-3 chcal intubation and provides the controllability of flexible fibcroptic bronchoscopy, portability of bougie 4 as well as malleability of guide wire, in addition to having the capability of mounting a smartphone as displaying screen, recording device, and the source of cold light.
6 Background of the Invention 7 Millions of people get general anesthesia every year worldwide. A critical part of the anesthesia process 8 is securing airways of patients' in order to assist them for breathing. This procedure is required because 9 these patients are already unconscious and paralyzed, and as a result they cannot breath nor protect their airways from secretions, saliva and blood (because the airway protecting reflexes are also blunted).
ii Difficult airway management is an everyday potential problem in Operation Rooms, emergency rooms, 12 ICUs as well as pre-hospital scenarios. If we could predict difficulty in airway management in a patient 13 before anesthesia induction, we usually get prepared in advance by different approaches such as awake 14 intubation (e.g., using flexible fibrotic laryngoscope), retrograde intubation, or Laryngeal mask airway (LMA). There are times when airway management of a patient who is already under general anesthesia, 16 encounters difficulty, and as a result the patient cannot be intubated.
This problem also could occur to a 17 multiple trauma patient whose alertness and consciousness have been compromised, because of different 18 reasons such as head trauma and gas poisoning. Maxillofacial trauma, which distorts the natural airway 19 passage and aspirating foreign body particles, could also compromise the patency of the airway lumen.
In these situations, available modalities are mostly guide wire, bougie, or similar products to LMA.
21 Our product is a device that addresses the challenges of using bougie and flexible fiberoptic devices for 22 both in and out of hospital cases. The most important features as well as challenges of the available 23 intubation assisting devices are described below.
24 Visualization and controllability are the most important features in intubation assisting devices. Vi-sualization feature of the device enables the examiner to view the airway inlet and proximal anatomy 26 in order to rule out abnormalities. In addition, high level of controllability in intubation device gives 27 the user fine-tuned re-adjustment control on the tip of the distal part.
This is important as the lack 28 of controllability poses risk of traumatization to the oral cavity and airway structures of the patient.
29 Among the other useful features are recording images and sending them for consultation which could give the examiner more options for future follow up.
31 The patent with publication number U.S. C.I. 128/200.26; 600/120 invented by Robert Michael Chuda 32 is an intubation device with video stylet steering prep and storage system.
In this device, bendability 33 of the distal part is limited, because of the design as well as the bending mechanism which prevents 34 the user from bending the distal end of the bougie more acutely. Moreover, as a result of the handle 35 design, the user has no direct view to the oral cavity and should just rely on the manoeuvrability and 36 the visual image he could get from the device monitor. This deprives the user from the potential use 37 of the left hand for holding the laryngoscope to push away the tip of the epiglottis in order to get 38 more exposure for the intubating device. Also, its pre-attached video display makes the device more 39 expensive to manufacture.
40 Another invented device having visualization feature is Bonfil fiberoscope with a curved end but rigid 41 fiberoptic enabled body, which is connected to a monitor by means of a cable. The user mounts the 42 endotracheal tube on the rigid stem of the device; and the tip of the device is navigated and passed 43 underneath the epiglottis and between the vocal cords. The problem with Bonfil fiberoscope is its rigid 44 stem. Consequently, in order to insert the device to the oral cavity of the patient, the user has to 45 give a round the clock maneuver to the handle part; and then navigates it beneath the epiglottis and 46 between the vocal cords. Maneuvers to the handle part are not necessarily fine-tuned at the distal part.
47 Furthermore, the user has to connect the proximal part of Bonfil fiberoscope to the monitor using cable 48 and as a result, utilization of the device for out of operation room settings (e.g., emergency room or even 49 out of hospital settings) is challenging. Another issue is the price of Bonfil fiberoscope, which makes it so unaffordable to use in many medical facilities and vehicles of first responder tearns around the world.
51 Also, this device is rigid, and therefore is not suitable for nasal intubation, which needs a flexible device 52 for passing through the nasal cavity to naso pharynx and also passing to the oropharyngial cavity.
53 In addition, in patent with publication number EP1981393 A2 named an intubation assisting device 54 with visualization capacity which is invented by Raymond Glassenberg et al, the price is still an issue 55 due to the price of a pre-installed video capturing part on the device.
56 Another invented device is mobile airway scope (MAF) from Olympus Medical Systems. This device 57 solves majority of aforementioned problems, as it has a monitor itself, and as a result it does not need 58 cable connections to external monitors. Also, external cold light source is not needed. Because of 59 its price, many health care providing units (e.g., community hospitals, ambulances, fire department 60 vehicles and health facilities in developing countries) cannot afford to have mobile airway scope (MAF).
61 Another issue is due to the design of its handle and the location of the displaying unit. As the user has 62 distance from the oral cavity of patient, he cannot use laryngoscope with his left hand while using the 63 intubation assisting device with his right hand. This omits the potential of using laryngoscope with 64 his left hand (which helps to more expose the inlet of the airway) while maneuvering the intubation 65 assisting device with his right hand.
66 As stated earlier, controllability is one of the most important features of an intubation assisting device.
67 (86) PCT Filing Number PCT/US1993/002912(Schroeder, Michael, George) describes a device which 68 has a handle to control curvature of the distal part of the bougie in order to re-adjust its shape according 69 to the patients airway anatomy. The problem with this device is that the amount of precision and control 70 over the curvature is limited.
71 Also, the invention with (86) PCT Filing Number PCT/US2008/066544 (Nearman et al.) is a laryngo-72 scope with a controllable distal part of the blade. In this invention cameras are used in order to assist 73 the user to better visualize the airway anatomy. Although this invention is helpful for intubation, the 74 user still needs to bring out the tube and re-adjust its shape according to the airway anatomy, and 75 re-use the new curvature on the endotracheal tube. Therefore, curvature adjustment of the endotracheal 76 tube is still challenging.
77 Bougie and guide wire are two other popular devices used for endotracheal intubation. Gum elastic 78 bougie is a fiberglass tube coated with resin like materials with a coude end at 38-40 degrees angle. The 79 user passes the bougie through the vocal cords, and then threads the endotracheal tube over the bougie 80 to aid passing the distal end of the tube to the trachea. Guide wire is a malleable wire, which is put 81 in the lumen of an endotracheal tube in order to give it more consistency.
As a result, the user could 82 adjust the shape arid angle of the distal part of the tube according to the patient's airway anatomy.
83 There have been several inventions to make these devices more useful. For instance, lighted bougie is a 84 stylet with a light at its distal end. This helps to trace the passage of the distal end to the trachea, and 85 also to confirm the successful intubation by seeing light through the front of the neck. The problem 86 with this device is that the user still cannot re-adjust its coude tail in accordance with the anatomy of 87 the patient's airway without taking out the bougie from the patient's oral cavity. In this scenario, the 88 user should re-adjust the angle of the coude tail manually, and then re-test the new angle for passing it 89 between the vocal cords. This action has two problems: first, it wastes the valuable and critical time as 90 repeating this procedure makes the patient more vulnerable to desaturation;
and second, this try and 91 error re-adjustment method of the coude tail could traumatize the airway and soft tissue of the hard 92 and soft palate.
93 Other devices which help in intubating the patient are the flexible fiberoptic laryngoscope, flexible 94 fiberoptic video laryngoscope, and flexible fiberoptic bronchoscope with the power to show and illu-minate the airway. Flexible fiberoptic bronchoscope has the flexibility to guide the endotracheal tube 96 between the vocal cords; however, this device is expensive and not all the hospitals, operation rooms, 97 emergency rooms, ambulances and fire department vehicles could afford to have one. The other problem 98 with flexible fiberoptic bronchoscope is its relatively long preparation time. The reason is that the cold 99 light source as well as monitors should be connected to the device through cables and all of them also 100 should be plugged in. This issue wastes the valuable critical time for the unconscious non-breathing pa-tient. Also, due to the mentioned challenges, usage of flexible fiberoptic bronchoscope is non-convenient 102 and even impossible for out of the hospital scenarios and in unexpected difficult airway management.
103 Summary of the Invention 104 This invention delivers the capabilities of popular airway management devices with affordable price.
105 Our device provides the controllability of flexible fiberoptic bronchoscopy, portability of bougie, as 106 well as malleability of guide wire. In addition, a smartphone can be mounted to our invented device;
107 therefore, capabilities of a smartphone, such as displaying screen, recording device, and the source of 108 cold light are available to the user. The stem of our device is flexible, and as a result the claimed device 109 could be used for both nasal and oral intubation. Also, it is suitable for both pre-hospital and hospital 110 cases of airway management.
in In comparison with mobile airway scope (MAF), in our claimed invention the source of cold light, video 112 capturing as well as recording feature are the user's smartphone.
Therefore, the device have much less 113 price, in terms of both purchase and future maintenance. As a result, the invented device is a great 114 option especially for health systems in low income countries and in disaster situations as well as mass 115 casualties. Furthermore, as each user mounts his own smartphone on the device, he has his own personal 116 image library of the patients' airway anatomy and video of the performed procedures. This library has 117 the potential to be used for future follow up and consultation regarding a specific patient case as well 118 as broader purposes, including research and teaching objectives. Also, our claimed invention gives more 119 control to the user compared to mobile airway scope (MAF). Mobile airway scope (MAF) is a flexible 120 fiberoptic. and as a result more power cannot be transmitted to the tip of the device and the user is 121 not able to push the epiglottis in cases of mallampati 4 score. However, in our claimed invention the 122 user is able to mount the malleable tube part over the flexible part of the device in case he needs more 123 strength and/ or adjustability considering patients airway anatomy and conditions. Due to the design 124 of the handle, the user also has the potential to use laryngoscope with the left hand (to more expose 125 the inlet of the airway) and simultaneously maneuver our claimed intubation assisting device with the 126 right hand.
127 Compared to the intubation device invented by Robert Michael Chuda, our claimed invention uses 128 smartphone as a detachable video unit; therefore, our device has less price. In addition, the design 129 of distal end of our claimed invention provides the user with fine-tuned re-adjustment of the distal 130 part. Moreover, due to the design of its handle, intubation device invented by Robert Michael Chuda, 131 deprives the user from the potential of using laryngoscope with the left hand while moneuvering the 132 device with the right hand. =
133 In comparison with flexible fibrotic laryngoscope, our device has lower cost, less complexity, and lighter 134 weight. Also, better intubation field view and better control over distal end of the device are among 135 the key differences between our claimed invention and the simple as well as lighted bougies.
136 To conclude, visualization capability as well as high level of controllability makes our claimed invention 137 suitable for all cases of intubation especially difficult airway management scenarios.
138 In the drawing, which form a part of this specification, 139 Fig. 1 is a semi-diagrammatic lateral perspective view of the smartphone enabled bougie with handle 140 adjustability, which consists of a flexible controllable part, a flexible cylinder shaped tubing, fiberoptic 141 elements, lenses, a malleable detachable cover, a detachable smartphone cartridge, a collar for the 142 handle frame, an adjustable handle, and an ergonomically shaped frame;
143 Fig. 2 is a semi-diagrammatic rear view of the invented device depicting rear view of the handle frame, 144 the collar of the frame and the detachabale smartphone cartridge;
145 Fig. 3 is a semi-diagrammatic upper view of the invented device;
146 Fig. 4 is a semi-diagrammatic longitudinal sectional view of the handle frame, the handle, the collar 147 part of the frame, attaching parts which connect detachable smartphone cartridge to the collar part, 148 and inside working elements of the handle frame and collar of the frame;
149 Fig. 5 is a semi-diagrammatic lateral perspective and rear view of handle-to-cable connector piece;
150 Fig. 6 is a semi-diagrammatic rear cross section view of the invented device; and 151 Fig. 7 is a semi-diagrammatic longitudinal and cross section view of the end cap and the end bead.
152 Detailed Description of the Invention 153 The invention is a re-adjustable fiberoptic enabled bougie with a detachable jacket for mounting a 154 smartphone. In this device, a flexible controllable part (1) is connected to the end of a flexible cylinder 155 shaped tubing (2), which both contain a flexible image fiber-optic bundle (3), flexible illumination fibers 156 (4), and a force transmission cable (5) to bend and re-adjust the flexible controllable part (1). The 157 flexible image fiber-optic bundle (3) is used to transmit image from a front (distal) image lens (6) at the 158 distal end of the flexible controllable part (1) to the image transmission unit(proximal)(7) and then to 159 the srnartphone through collar (8) of the frame (9); light emitted by the light source of the smartphone 160 mounted on the detachable smartphone jacket (10) is coupled into the flexible illumination fibers (4) 161 by a lens (proximal illumination lens) (11) at the collar (8) of the frame (9), and then the light is 162 transmitted to the distal end of the flexible controllable part (1) using the flexible illumination fibers 163 (4).
164 In the end of the flexible illumination fibers (4), a lens (distal illumination lens)(12) is located which is could also protect thc flexible illumination fibers (4) from patients' oral cavity secritions as well as 166 detergents used to disinfect the device after use.
167 The image transmission components which transmit image from distal end of the flexible controllable 168 part to the attached smartphone camera, and illumination components which transmit light from smart-169 phone cold light source to the distal end of the flexible controllable part, as well as flexibility mechanics of the flexible cylinder shaped tubing are similar to the conventional flexible part of the flexible fiberoptic 171 broncoscopes, and therefore; they are riot being described further.
172 The force transmission cable (5) connects to handle-to-cable connector piece (13) in collar (8) of the 173 frame (9) in a way that the cable is placed above the center of the flexible image fiber-optic bundle 174 (3) and the flexible illumination fibers (4). Then, the force transmission cable (5) passes along the 175 flexible cylinder shaped tubing (2) and enters into the flexible controllable part (1) in which the force 176 transmission cable (5) connects to the upper portion of the end bead (14).
The end bead (14) is fixed 177 in the end cap (15), which contains image distal lens (6) as well as illumination distal lens (12).
178 Two springs (16) located in the back of the frame (9) bring back the position of the adjustable handle 179 (17) to the initial position upon release of the adjustable handle (17).
This initial position is the postion 180 in which the flexible controllable part (1) is straight.
181 The other supporting parts of the claimed invented device are a sliding button (20) and a spring behind 182 it (21), which keeps the sliding stud (22) in the detachable smartphone jacket's hole (23). A tongue 183 (24) in front of the detachable smartphone jacket as well as a groove (25) on the collar (8) of the frame 184 (9) keeps the smartphone in place. All of the elements inside the flexible controllable part (1) and 185 flexible cylinder shaped tubing (2) are surrounded by a water resistant tube filling compound (26). The 186 flexible controllable part (1) and flexible cylinder shaped tubing (2) are covered by a non-allergenic 187 disinfectable polymeric material (27).
188 The flexible cylinder shaped tubing (2) is covered by a malleable detachable cover (18). A detachable 189 smartphone jacket (10) is used to mount a smartphone on the collar (8) of the frame (9). The flexible 190 cylinder shaped tubing (2) is connected to the ergonomically shaped frame (9) through its collar (8).
191 To use our invented device in operation, a conventional endoteracheal tube is mounted on the flexible 192 cylinder shaped tubing (2) in a way that the end of flexible controllable part (1) be free of any covering.
193 This design enables the end of the flexible controllable part (1) to move freely in necessary direction.
194 In operation, the user applies a conventional laryngoscope by his left hand in order to push away the 195 base of the patient's tongue and put the tip of the blade in valecula to lift epiglottis. Afterwards, the 196 user keeps our claimed invented device in his right hand by putting his thumb in the notch (19) at the 197 proximal part of the frame (9) and putting his index finger in the hole of the adjustable handle (17).
198 After putting the device in the mouth of the patient, the user can view the airway anatomy not only 199 on the screen of the smartphone but also directly through the patients' open mouth. This could be a 200 good backup potential if the front (distal) image lens (6) gets foggy or the user needs to change his 201 view angle. As the user proceeds to the oropharynx, he re-adjusts the curvature of the distal end of 202 the flexible controllable part (1) according to the patients' airway anatomy in a way that eventually 203 he could pass it between the vocal cords to the inlet of the trachea. At this stage the user puts aside 204 the laryngoscope, which he had in his left hand. As the final stage of the intubation procedure, while 205 watching the airway anatomy through the smartphone screen, the user passes the endoteracheal tube 206 by his freed left hand between the vocal cords, and takes out the claimed invented intubation device 207 from the patients' oral cavity.
6 Background of the Invention 7 Millions of people get general anesthesia every year worldwide. A critical part of the anesthesia process 8 is securing airways of patients' in order to assist them for breathing. This procedure is required because 9 these patients are already unconscious and paralyzed, and as a result they cannot breath nor protect their airways from secretions, saliva and blood (because the airway protecting reflexes are also blunted).
ii Difficult airway management is an everyday potential problem in Operation Rooms, emergency rooms, 12 ICUs as well as pre-hospital scenarios. If we could predict difficulty in airway management in a patient 13 before anesthesia induction, we usually get prepared in advance by different approaches such as awake 14 intubation (e.g., using flexible fibrotic laryngoscope), retrograde intubation, or Laryngeal mask airway (LMA). There are times when airway management of a patient who is already under general anesthesia, 16 encounters difficulty, and as a result the patient cannot be intubated.
This problem also could occur to a 17 multiple trauma patient whose alertness and consciousness have been compromised, because of different 18 reasons such as head trauma and gas poisoning. Maxillofacial trauma, which distorts the natural airway 19 passage and aspirating foreign body particles, could also compromise the patency of the airway lumen.
In these situations, available modalities are mostly guide wire, bougie, or similar products to LMA.
21 Our product is a device that addresses the challenges of using bougie and flexible fiberoptic devices for 22 both in and out of hospital cases. The most important features as well as challenges of the available 23 intubation assisting devices are described below.
24 Visualization and controllability are the most important features in intubation assisting devices. Vi-sualization feature of the device enables the examiner to view the airway inlet and proximal anatomy 26 in order to rule out abnormalities. In addition, high level of controllability in intubation device gives 27 the user fine-tuned re-adjustment control on the tip of the distal part.
This is important as the lack 28 of controllability poses risk of traumatization to the oral cavity and airway structures of the patient.
29 Among the other useful features are recording images and sending them for consultation which could give the examiner more options for future follow up.
31 The patent with publication number U.S. C.I. 128/200.26; 600/120 invented by Robert Michael Chuda 32 is an intubation device with video stylet steering prep and storage system.
In this device, bendability 33 of the distal part is limited, because of the design as well as the bending mechanism which prevents 34 the user from bending the distal end of the bougie more acutely. Moreover, as a result of the handle 35 design, the user has no direct view to the oral cavity and should just rely on the manoeuvrability and 36 the visual image he could get from the device monitor. This deprives the user from the potential use 37 of the left hand for holding the laryngoscope to push away the tip of the epiglottis in order to get 38 more exposure for the intubating device. Also, its pre-attached video display makes the device more 39 expensive to manufacture.
40 Another invented device having visualization feature is Bonfil fiberoscope with a curved end but rigid 41 fiberoptic enabled body, which is connected to a monitor by means of a cable. The user mounts the 42 endotracheal tube on the rigid stem of the device; and the tip of the device is navigated and passed 43 underneath the epiglottis and between the vocal cords. The problem with Bonfil fiberoscope is its rigid 44 stem. Consequently, in order to insert the device to the oral cavity of the patient, the user has to 45 give a round the clock maneuver to the handle part; and then navigates it beneath the epiglottis and 46 between the vocal cords. Maneuvers to the handle part are not necessarily fine-tuned at the distal part.
47 Furthermore, the user has to connect the proximal part of Bonfil fiberoscope to the monitor using cable 48 and as a result, utilization of the device for out of operation room settings (e.g., emergency room or even 49 out of hospital settings) is challenging. Another issue is the price of Bonfil fiberoscope, which makes it so unaffordable to use in many medical facilities and vehicles of first responder tearns around the world.
51 Also, this device is rigid, and therefore is not suitable for nasal intubation, which needs a flexible device 52 for passing through the nasal cavity to naso pharynx and also passing to the oropharyngial cavity.
53 In addition, in patent with publication number EP1981393 A2 named an intubation assisting device 54 with visualization capacity which is invented by Raymond Glassenberg et al, the price is still an issue 55 due to the price of a pre-installed video capturing part on the device.
56 Another invented device is mobile airway scope (MAF) from Olympus Medical Systems. This device 57 solves majority of aforementioned problems, as it has a monitor itself, and as a result it does not need 58 cable connections to external monitors. Also, external cold light source is not needed. Because of 59 its price, many health care providing units (e.g., community hospitals, ambulances, fire department 60 vehicles and health facilities in developing countries) cannot afford to have mobile airway scope (MAF).
61 Another issue is due to the design of its handle and the location of the displaying unit. As the user has 62 distance from the oral cavity of patient, he cannot use laryngoscope with his left hand while using the 63 intubation assisting device with his right hand. This omits the potential of using laryngoscope with 64 his left hand (which helps to more expose the inlet of the airway) while maneuvering the intubation 65 assisting device with his right hand.
66 As stated earlier, controllability is one of the most important features of an intubation assisting device.
67 (86) PCT Filing Number PCT/US1993/002912(Schroeder, Michael, George) describes a device which 68 has a handle to control curvature of the distal part of the bougie in order to re-adjust its shape according 69 to the patients airway anatomy. The problem with this device is that the amount of precision and control 70 over the curvature is limited.
71 Also, the invention with (86) PCT Filing Number PCT/US2008/066544 (Nearman et al.) is a laryngo-72 scope with a controllable distal part of the blade. In this invention cameras are used in order to assist 73 the user to better visualize the airway anatomy. Although this invention is helpful for intubation, the 74 user still needs to bring out the tube and re-adjust its shape according to the airway anatomy, and 75 re-use the new curvature on the endotracheal tube. Therefore, curvature adjustment of the endotracheal 76 tube is still challenging.
77 Bougie and guide wire are two other popular devices used for endotracheal intubation. Gum elastic 78 bougie is a fiberglass tube coated with resin like materials with a coude end at 38-40 degrees angle. The 79 user passes the bougie through the vocal cords, and then threads the endotracheal tube over the bougie 80 to aid passing the distal end of the tube to the trachea. Guide wire is a malleable wire, which is put 81 in the lumen of an endotracheal tube in order to give it more consistency.
As a result, the user could 82 adjust the shape arid angle of the distal part of the tube according to the patient's airway anatomy.
83 There have been several inventions to make these devices more useful. For instance, lighted bougie is a 84 stylet with a light at its distal end. This helps to trace the passage of the distal end to the trachea, and 85 also to confirm the successful intubation by seeing light through the front of the neck. The problem 86 with this device is that the user still cannot re-adjust its coude tail in accordance with the anatomy of 87 the patient's airway without taking out the bougie from the patient's oral cavity. In this scenario, the 88 user should re-adjust the angle of the coude tail manually, and then re-test the new angle for passing it 89 between the vocal cords. This action has two problems: first, it wastes the valuable and critical time as 90 repeating this procedure makes the patient more vulnerable to desaturation;
and second, this try and 91 error re-adjustment method of the coude tail could traumatize the airway and soft tissue of the hard 92 and soft palate.
93 Other devices which help in intubating the patient are the flexible fiberoptic laryngoscope, flexible 94 fiberoptic video laryngoscope, and flexible fiberoptic bronchoscope with the power to show and illu-minate the airway. Flexible fiberoptic bronchoscope has the flexibility to guide the endotracheal tube 96 between the vocal cords; however, this device is expensive and not all the hospitals, operation rooms, 97 emergency rooms, ambulances and fire department vehicles could afford to have one. The other problem 98 with flexible fiberoptic bronchoscope is its relatively long preparation time. The reason is that the cold 99 light source as well as monitors should be connected to the device through cables and all of them also 100 should be plugged in. This issue wastes the valuable critical time for the unconscious non-breathing pa-tient. Also, due to the mentioned challenges, usage of flexible fiberoptic bronchoscope is non-convenient 102 and even impossible for out of the hospital scenarios and in unexpected difficult airway management.
103 Summary of the Invention 104 This invention delivers the capabilities of popular airway management devices with affordable price.
105 Our device provides the controllability of flexible fiberoptic bronchoscopy, portability of bougie, as 106 well as malleability of guide wire. In addition, a smartphone can be mounted to our invented device;
107 therefore, capabilities of a smartphone, such as displaying screen, recording device, and the source of 108 cold light are available to the user. The stem of our device is flexible, and as a result the claimed device 109 could be used for both nasal and oral intubation. Also, it is suitable for both pre-hospital and hospital 110 cases of airway management.
in In comparison with mobile airway scope (MAF), in our claimed invention the source of cold light, video 112 capturing as well as recording feature are the user's smartphone.
Therefore, the device have much less 113 price, in terms of both purchase and future maintenance. As a result, the invented device is a great 114 option especially for health systems in low income countries and in disaster situations as well as mass 115 casualties. Furthermore, as each user mounts his own smartphone on the device, he has his own personal 116 image library of the patients' airway anatomy and video of the performed procedures. This library has 117 the potential to be used for future follow up and consultation regarding a specific patient case as well 118 as broader purposes, including research and teaching objectives. Also, our claimed invention gives more 119 control to the user compared to mobile airway scope (MAF). Mobile airway scope (MAF) is a flexible 120 fiberoptic. and as a result more power cannot be transmitted to the tip of the device and the user is 121 not able to push the epiglottis in cases of mallampati 4 score. However, in our claimed invention the 122 user is able to mount the malleable tube part over the flexible part of the device in case he needs more 123 strength and/ or adjustability considering patients airway anatomy and conditions. Due to the design 124 of the handle, the user also has the potential to use laryngoscope with the left hand (to more expose 125 the inlet of the airway) and simultaneously maneuver our claimed intubation assisting device with the 126 right hand.
127 Compared to the intubation device invented by Robert Michael Chuda, our claimed invention uses 128 smartphone as a detachable video unit; therefore, our device has less price. In addition, the design 129 of distal end of our claimed invention provides the user with fine-tuned re-adjustment of the distal 130 part. Moreover, due to the design of its handle, intubation device invented by Robert Michael Chuda, 131 deprives the user from the potential of using laryngoscope with the left hand while moneuvering the 132 device with the right hand. =
133 In comparison with flexible fibrotic laryngoscope, our device has lower cost, less complexity, and lighter 134 weight. Also, better intubation field view and better control over distal end of the device are among 135 the key differences between our claimed invention and the simple as well as lighted bougies.
136 To conclude, visualization capability as well as high level of controllability makes our claimed invention 137 suitable for all cases of intubation especially difficult airway management scenarios.
138 In the drawing, which form a part of this specification, 139 Fig. 1 is a semi-diagrammatic lateral perspective view of the smartphone enabled bougie with handle 140 adjustability, which consists of a flexible controllable part, a flexible cylinder shaped tubing, fiberoptic 141 elements, lenses, a malleable detachable cover, a detachable smartphone cartridge, a collar for the 142 handle frame, an adjustable handle, and an ergonomically shaped frame;
143 Fig. 2 is a semi-diagrammatic rear view of the invented device depicting rear view of the handle frame, 144 the collar of the frame and the detachabale smartphone cartridge;
145 Fig. 3 is a semi-diagrammatic upper view of the invented device;
146 Fig. 4 is a semi-diagrammatic longitudinal sectional view of the handle frame, the handle, the collar 147 part of the frame, attaching parts which connect detachable smartphone cartridge to the collar part, 148 and inside working elements of the handle frame and collar of the frame;
149 Fig. 5 is a semi-diagrammatic lateral perspective and rear view of handle-to-cable connector piece;
150 Fig. 6 is a semi-diagrammatic rear cross section view of the invented device; and 151 Fig. 7 is a semi-diagrammatic longitudinal and cross section view of the end cap and the end bead.
152 Detailed Description of the Invention 153 The invention is a re-adjustable fiberoptic enabled bougie with a detachable jacket for mounting a 154 smartphone. In this device, a flexible controllable part (1) is connected to the end of a flexible cylinder 155 shaped tubing (2), which both contain a flexible image fiber-optic bundle (3), flexible illumination fibers 156 (4), and a force transmission cable (5) to bend and re-adjust the flexible controllable part (1). The 157 flexible image fiber-optic bundle (3) is used to transmit image from a front (distal) image lens (6) at the 158 distal end of the flexible controllable part (1) to the image transmission unit(proximal)(7) and then to 159 the srnartphone through collar (8) of the frame (9); light emitted by the light source of the smartphone 160 mounted on the detachable smartphone jacket (10) is coupled into the flexible illumination fibers (4) 161 by a lens (proximal illumination lens) (11) at the collar (8) of the frame (9), and then the light is 162 transmitted to the distal end of the flexible controllable part (1) using the flexible illumination fibers 163 (4).
164 In the end of the flexible illumination fibers (4), a lens (distal illumination lens)(12) is located which is could also protect thc flexible illumination fibers (4) from patients' oral cavity secritions as well as 166 detergents used to disinfect the device after use.
167 The image transmission components which transmit image from distal end of the flexible controllable 168 part to the attached smartphone camera, and illumination components which transmit light from smart-169 phone cold light source to the distal end of the flexible controllable part, as well as flexibility mechanics of the flexible cylinder shaped tubing are similar to the conventional flexible part of the flexible fiberoptic 171 broncoscopes, and therefore; they are riot being described further.
172 The force transmission cable (5) connects to handle-to-cable connector piece (13) in collar (8) of the 173 frame (9) in a way that the cable is placed above the center of the flexible image fiber-optic bundle 174 (3) and the flexible illumination fibers (4). Then, the force transmission cable (5) passes along the 175 flexible cylinder shaped tubing (2) and enters into the flexible controllable part (1) in which the force 176 transmission cable (5) connects to the upper portion of the end bead (14).
The end bead (14) is fixed 177 in the end cap (15), which contains image distal lens (6) as well as illumination distal lens (12).
178 Two springs (16) located in the back of the frame (9) bring back the position of the adjustable handle 179 (17) to the initial position upon release of the adjustable handle (17).
This initial position is the postion 180 in which the flexible controllable part (1) is straight.
181 The other supporting parts of the claimed invented device are a sliding button (20) and a spring behind 182 it (21), which keeps the sliding stud (22) in the detachable smartphone jacket's hole (23). A tongue 183 (24) in front of the detachable smartphone jacket as well as a groove (25) on the collar (8) of the frame 184 (9) keeps the smartphone in place. All of the elements inside the flexible controllable part (1) and 185 flexible cylinder shaped tubing (2) are surrounded by a water resistant tube filling compound (26). The 186 flexible controllable part (1) and flexible cylinder shaped tubing (2) are covered by a non-allergenic 187 disinfectable polymeric material (27).
188 The flexible cylinder shaped tubing (2) is covered by a malleable detachable cover (18). A detachable 189 smartphone jacket (10) is used to mount a smartphone on the collar (8) of the frame (9). The flexible 190 cylinder shaped tubing (2) is connected to the ergonomically shaped frame (9) through its collar (8).
191 To use our invented device in operation, a conventional endoteracheal tube is mounted on the flexible 192 cylinder shaped tubing (2) in a way that the end of flexible controllable part (1) be free of any covering.
193 This design enables the end of the flexible controllable part (1) to move freely in necessary direction.
194 In operation, the user applies a conventional laryngoscope by his left hand in order to push away the 195 base of the patient's tongue and put the tip of the blade in valecula to lift epiglottis. Afterwards, the 196 user keeps our claimed invented device in his right hand by putting his thumb in the notch (19) at the 197 proximal part of the frame (9) and putting his index finger in the hole of the adjustable handle (17).
198 After putting the device in the mouth of the patient, the user can view the airway anatomy not only 199 on the screen of the smartphone but also directly through the patients' open mouth. This could be a 200 good backup potential if the front (distal) image lens (6) gets foggy or the user needs to change his 201 view angle. As the user proceeds to the oropharynx, he re-adjusts the curvature of the distal end of 202 the flexible controllable part (1) according to the patients' airway anatomy in a way that eventually 203 he could pass it between the vocal cords to the inlet of the trachea. At this stage the user puts aside 204 the laryngoscope, which he had in his left hand. As the final stage of the intubation procedure, while 205 watching the airway anatomy through the smartphone screen, the user passes the endoteracheal tube 206 by his freed left hand between the vocal cords, and takes out the claimed invented intubation device 207 from the patients' oral cavity.
Claims (7)
1. I claim a smartphone enabled bougie which comprises a smartphone mounted on an endotracheal intubation stylet or bougie, and as a result the capabilities of smartphone are added to an endo-tracheal intubation stylet or bougie by using lens, camera, light source, power source, screen as well as memory of smartphone for getting and storing images of patient's airway anatomy and real time video of intubation procedure; images are transmitted from objective lens in the distal of the flexible controllable end part through an image fiber-optic bundle to image transmission unit (proximal) and then to the camera of the smartphone; the transmitted images are shown on the smartphone screen. The user is able to record the captured images of the airway arid the video of the intubation procedure on the memory of the smartphone; the light from the light source of the smartphone is guided through the illumination fibers to the illumination lens at the destal of the flexible controllable end part to illuminate the airway passage.
2. I claim fine-tuned distal end bending using flexible bronchoscope design in endotracheal intubation stylet or bougie. The design enables the user to adjust precisely curvature of the distal end of the device in even acute angles. The bending mechanism uses a force transmission cable to transmit force from the adjustable handle to the bending distal end of the bougie. By pulling the adjustable handle using fingers, the user is able to adjust the curvature of the distal end according to the patient's airway anatomy to navigate the distal end between the vocal cords.
3. The combination of mounting and using smartphone as well as having distal end adjustability on intubation stylet or bougie are claimed. The intubation device has the necessary parts to mount and use a smartphone in claim 1 in addition to a fine-tuned distal end bending mechanism using force transmission cable design in claim 2.
4. The design of intubation stylet or bougie with a handle which is connected in a way to provide direct view of airway anatomy is claimed. The grasp of the handle enables the user to control the device and perform the procedure, while the position of his hand does not interfere with the direct view of the patients' airway.
5. The design of intubation device with a handle which gives the user the ability to exploit rotating maneuver of his wrist to navigate the device, while having the direct view of airway is claimed.
The design of the handle enables the user to hold the device using his right hand and use a laryngoscope by his left hand, simultaneously.
The design of the handle enables the user to hold the device using his right hand and use a laryngoscope by his left hand, simultaneously.
6. The capability of mounting the malleable non-allergenic disinfectable metallic or polymeric pipe on the flexible cylinder shaped tubing of the intubation device is claimed.
When performing oral intubation by mounting the malleable non-allergenic disinfectable metallic or polymeric pipe on the flexible cylinder shaped tubing, the user can transmit more force to the bending distal end in order to push away epiglottis.
When performing oral intubation by mounting the malleable non-allergenic disinfectable metallic or polymeric pipe on the flexible cylinder shaped tubing, the user can transmit more force to the bending distal end in order to push away epiglottis.
7. I claim the ornamental design of the smartphone enabled bougie with handle adjustability which is shown in FIG. 1 to FIG. 7 and comprising:
(a) A flexible controllable part (1) with a coating made of non-allergenic polymeric, plastic, or other non-allergenic disinfectable materials, which provides fine-tuned bending mechanism of bougie using the force transmission cable fixed to the end bead and the end cap;
(b) A flexible cylinder shaped tubing (2) which is connected to the collar of the frame, has a coating made of non-allergenic polymeric, plastic, or other non-allergenic disinfectable ma-terials; and contains a flexible image fiber-optic bundle, a flexible illumination fibers, a force transmission cable; and a water resistance tube filling compound which surrounds the flexible image fiber-optic bundle, the flexible illumination fibers, inside the flexible controllable part, and the flexible cylinder shaped tubing;
(c) A flexible image fiber-optic bundle (3) to transmit image from a front (distal) image lens at the distal end of the flexible controllable part to the image transmission unit (proximal) and then to the smartphone through collar of the frame;
(d) Flexible illumination fibers (4) to transmit light from the light source of the smartphone to the distal end of the flexible controllable part;
(e) A force transmission cable (5) which is a flexible metallic cable lies in the flexible cylinder shaped tubing and the flexible controllable part, and transmits force from adjustable handle to the distal end of the flexible controllable part for bending. This mechanism of control is simpler than existing conventional force transmissions in flexible bronchoscopes;
(f) A front (distal) image lens (6) which is at the distal end of the flexible controllable part, reflects the image of the object onto the end of the flexible image fiber-optic bundle in order to transmit image to the smartphone camera through collar of the frame;
(g) The image transmission unit (proximal) (7), which is projection optics, projects the trans-mitted image to the camera of the smartphone;
(h) A collar (8) of the frame, which is made of polymeric and metallic materials, contains image transmission unit (proximal), proximal illumination lens, sliding button, spring behind sliding button, sliding stud, collar groove, handle-to-cable connector piece, and an adjustable space to fit the detachable smartphone jacket part;
(i) A frame (9) part, which is ergonomically shaped for the user's fingers, contains a notch for the users' thumb, adjustable handle, two springs behind the adjustable handle, and proximal end of handle-to-cable connector piece; the frame is connected to the proximal end of the flexible cylinder shaped tubing;
(j) The detachable smartphone jacket (10), which is customized for each type of smartphone, is connected to the collar of the frame by smartphone jacket tongue, which is put in collar groove and is fixed by sliding stud of the collar. This sliding stud is put in the detachable smartphone jacket hole;
(k) A proximal illumination lens (11) at the collar is used to couple the maximum amount of light emitted by the light source of the smartphone into the flexible illumination fibers;
(1) A distal illumination lens (12) at the end of the flexible illumination fibers to protect the flexible illumination fibers from patients' oral cavity secretions and from disinfectants used to sterilize the device. The distal illumination lens at the end of the illumination fibers is also used to deliver the transmitted light evenly;
(m) A handle-to-cable connector piece (13) in collar is used to transmit force from the adjustable handle to the force transmission cable (5) that lays in the upper half of the flexible cylinder shaped tubing (2) and flexible controllable part (1). In flexible controllable part (1), this cable is fixed to the upper part of the end bead (14) from inside;
(n) The end bead (14) is fixed inside the end cap (15) and encompasses and protects flexible image fiber-optic bundle (3)and flexible illumination fibers (4);
(o) The end cap (15) contains image distal lens (6) as well as illumination distal lens (12) and encompasses the end bead (14);
(p) Two springs (16) located in the frame of the handle keep the adjustable handle (13) in its nutral position;
(q) The adjustable handle (17) is movable and made of polymeric plastic or metallic material;
the adjustable handle is connected to the handle-to-cable connector piece;
(r) A malleable detachable cover (18) is a non-allergenic disinfectable metallic or polymeric pipe, which is mounted on the flexible cylinder shaped tubing.
(a) A flexible controllable part (1) with a coating made of non-allergenic polymeric, plastic, or other non-allergenic disinfectable materials, which provides fine-tuned bending mechanism of bougie using the force transmission cable fixed to the end bead and the end cap;
(b) A flexible cylinder shaped tubing (2) which is connected to the collar of the frame, has a coating made of non-allergenic polymeric, plastic, or other non-allergenic disinfectable ma-terials; and contains a flexible image fiber-optic bundle, a flexible illumination fibers, a force transmission cable; and a water resistance tube filling compound which surrounds the flexible image fiber-optic bundle, the flexible illumination fibers, inside the flexible controllable part, and the flexible cylinder shaped tubing;
(c) A flexible image fiber-optic bundle (3) to transmit image from a front (distal) image lens at the distal end of the flexible controllable part to the image transmission unit (proximal) and then to the smartphone through collar of the frame;
(d) Flexible illumination fibers (4) to transmit light from the light source of the smartphone to the distal end of the flexible controllable part;
(e) A force transmission cable (5) which is a flexible metallic cable lies in the flexible cylinder shaped tubing and the flexible controllable part, and transmits force from adjustable handle to the distal end of the flexible controllable part for bending. This mechanism of control is simpler than existing conventional force transmissions in flexible bronchoscopes;
(f) A front (distal) image lens (6) which is at the distal end of the flexible controllable part, reflects the image of the object onto the end of the flexible image fiber-optic bundle in order to transmit image to the smartphone camera through collar of the frame;
(g) The image transmission unit (proximal) (7), which is projection optics, projects the trans-mitted image to the camera of the smartphone;
(h) A collar (8) of the frame, which is made of polymeric and metallic materials, contains image transmission unit (proximal), proximal illumination lens, sliding button, spring behind sliding button, sliding stud, collar groove, handle-to-cable connector piece, and an adjustable space to fit the detachable smartphone jacket part;
(i) A frame (9) part, which is ergonomically shaped for the user's fingers, contains a notch for the users' thumb, adjustable handle, two springs behind the adjustable handle, and proximal end of handle-to-cable connector piece; the frame is connected to the proximal end of the flexible cylinder shaped tubing;
(j) The detachable smartphone jacket (10), which is customized for each type of smartphone, is connected to the collar of the frame by smartphone jacket tongue, which is put in collar groove and is fixed by sliding stud of the collar. This sliding stud is put in the detachable smartphone jacket hole;
(k) A proximal illumination lens (11) at the collar is used to couple the maximum amount of light emitted by the light source of the smartphone into the flexible illumination fibers;
(1) A distal illumination lens (12) at the end of the flexible illumination fibers to protect the flexible illumination fibers from patients' oral cavity secretions and from disinfectants used to sterilize the device. The distal illumination lens at the end of the illumination fibers is also used to deliver the transmitted light evenly;
(m) A handle-to-cable connector piece (13) in collar is used to transmit force from the adjustable handle to the force transmission cable (5) that lays in the upper half of the flexible cylinder shaped tubing (2) and flexible controllable part (1). In flexible controllable part (1), this cable is fixed to the upper part of the end bead (14) from inside;
(n) The end bead (14) is fixed inside the end cap (15) and encompasses and protects flexible image fiber-optic bundle (3)and flexible illumination fibers (4);
(o) The end cap (15) contains image distal lens (6) as well as illumination distal lens (12) and encompasses the end bead (14);
(p) Two springs (16) located in the frame of the handle keep the adjustable handle (13) in its nutral position;
(q) The adjustable handle (17) is movable and made of polymeric plastic or metallic material;
the adjustable handle is connected to the handle-to-cable connector piece;
(r) A malleable detachable cover (18) is a non-allergenic disinfectable metallic or polymeric pipe, which is mounted on the flexible cylinder shaped tubing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA 2816265 CA2816265A1 (en) | 2013-05-08 | 2013-05-08 | Smartphone enabled bougie with handle adjustability |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA 2816265 CA2816265A1 (en) | 2013-05-08 | 2013-05-08 | Smartphone enabled bougie with handle adjustability |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2816265A1 true CA2816265A1 (en) | 2014-11-08 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2816265 Abandoned CA2816265A1 (en) | 2013-05-08 | 2013-05-08 | Smartphone enabled bougie with handle adjustability |
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| Country | Link |
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| CA (1) | CA2816265A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110680268A (en) * | 2019-11-11 | 2020-01-14 | 吉林大学 | Visual stereoplasm bronchoscope of paediatrics |
-
2013
- 2013-05-08 CA CA 2816265 patent/CA2816265A1/en not_active Abandoned
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110680268A (en) * | 2019-11-11 | 2020-01-14 | 吉林大学 | Visual stereoplasm bronchoscope of paediatrics |
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