Patent Application
20160256646
The embodiments described herein generally relate to the ability to selectively ventilate one lung or portion thereof during ventilation of a patient through an endotracheal tube or other body-inserted medical tube.
Ventilation of a patient through a single-lumen endotracheal tube results in essentially equal ventilation of both lung fields simultaneously. There are instances when it may be clinically advantageous to be able to ventilate only one lung at a given time. For example, the most common clinical situation when ventilation of only one lung is desired is during thoracic surgery (either open or thoracoscopic), in which, for visualization and technical reasons, it may be necessary to cease ventilation to the lung that is being operated upon. A less common clinical situation can occur when there is pathology in one lung (such as excessive air leak, hemorrhage, or infection) that needs to be mechanically isolated from the normally-functioning lung.
There are currently two main options for single-lung isolation during ventilation. The first option is the use of a double-lumen endotracheal tube, where one lumen of the endotracheal tube is placed into either the right or left main stem bronchus and a balloon is inflated within that bronchus. Subsequently, at the discretion of the clinician, ventilation can be accomplished utilizing only the lung whose main stem was intubated, using only the other lung whose main stem was not intubated, or through a Y-connector that allows ventilation of both lungs. Double-lumen endotracheal tubes can be somewhat stiff and difficult to position. Appropriate positioning can be assessed either through indirect clinical measurements, such as breath sounds, or utilizing a pediatric-size bronchoscope to visually verify its correct placement. The stiffness and size of these double-lumen endotracheal tubes has been associated with bronchial mucosal injury, such as hemorrhage. Once the double-lumen tube is confirmed in position and the surgical procedure is underway, possible dislodgement or other difficulties with ventilation require reinserting a bronchoscope, often with the patient not in a favorable anatomic position, to try to reposition the double-lumen tube.
The second option for single-lung isolation during ventilation is to use a bronchial blocker. In its simplest form, the bronchial blocker is a balloon catheter that is placed through a single-lumen endotracheal tube and then into either the right or left main stem bronchus. Once the balloon is inflated, ventilation only occurs in the opposite lung. Usually, the bronchial blocker is placed utilizing a bronchoscope which, since the bronchoscope and bronchial blocker are both within the endotracheal tube, can cause temporary airway obstruction or difficulty in ventilating the patient.
In accordance with several embodiments, an endobronchial blocker is provided having an outer diameter of approximately 3 mm and having its own reversibly-coupled visualization system. In various embodiments, the reversibly-coupled visualization system advantageously allows the blocker to: i) be placed under direct vision without obstruction of a single-lumen endotracheal tube, ii) confirm appropriate expansion and seating within the chosen main stem bronchus, and/or iii) when pulled back proximal of a balloon of the blocker, can be left in place and used in real-time fashion to monitor the position of the blocker throughout the entire surgical procedure. In some embodiments, the visualization system is not an integral part of the endotracheal tube and can be moved separately from the endotracheal tube itself.
In accordance with several embodiments, the endobronchial blocker described herein is designed to be used with the visualization and/or cleaning devices and systems described in one or more of the following patent applications, each of which is hereby incorporated herein by reference: WIPO Publ. No. WO 2013/063520, published on May 2, 2013 and U.S. Provisional Application No. 61/733,371, filed Dec. 4, 2012. For example, the embodiments of endobronchial blockers described herein may be used in conjunction with the adapters or coupling members (e.g., adapters or coupling members 121, 2400, 2400′, 2421, 2422, 2440, 2500, 2555) described in WIPO Publ. No. WO 2013/063520.
In accordance with several embodiments, a system configured to selectively block respiratory air flow to a lung is provided. In one embodiment, the system comprises an elongate member (e.g., catheter) having a proximal end and a distal end and a central lumen extending from the proximal end to the distal end. In one embodiment, the proximal end of the elongate member is open and the distal end of the elongate member is closed or sealed off to outside air. The distal end of the catheter may comprise a window configured to facilitate visualization beyond the window. In one embodiment, the catheter comprises an inflatable member (e.g., balloon) positioned along a distal portion of the catheter. The catheter may comprise a pilot or inflation channel within a wall of the catheter surrounding the central lumen configured to facilitate inflation and deflation of the inflatable member. In one embodiment, the system comprises a retention assembly configured to exert a force on a visualization device (e.g., scope) inserted within the central lumen of the catheter to cause a distal end of the visualization device to be pressed against, or in close proximity to, the window at the distal end of the catheter. Non-inflatable expandable members may be used in other embodiments.
In one embodiment, the catheter comprises a sheath along at least a portion of its length. At least a portion of the sheath of the catheter (e.g., a distal-most portion, such as the distal 1-6 cm, 0.5 cm-1 cm, 1 cm-4 cm, 1.5 cm-5 cm, 2 cm-8 cm, 3 cm-6 cm, 4 cm-10 cm) may be substantially transparent to allow for visualization outside of the wall of the catheter. In one embodiment, the entire sheath is at least substantially optically transparent or clear.
In some embodiments, the system comprises an inflation control member at a proximal end of the catheter (e.g., to control inflation of a balloon disposed on the catheter). In one embodiment, the catheter comprises a second channel (e.g., auxiliary channel) within the wall of the catheter surrounding the central lumen. The second channel may comprise a distal opening or exit distal to the inflatable member (e.g., balloon) and proximal to the window or closed distal tip of the catheter to facilitate delivery of air and/or fluids to an airway of a patient through the second channel.
In some embodiments, the system comprises a visualization device (e.g., visualization scope) configured to be inserted within the central lumen of the catheter. In one embodiment, the system comprises a multi-port connector with two, three, four or more ports configured to be coupled to a proximal end of an endotracheal tube or other body-inserted tube. The catheter may be configured to be inserted within a port of the multi-port connector, through the endotracheal tube, and advanced to a location within a bronchus of a lung. In one embodiment, the system comprises a compression member (e.g. compression cap) that is configured to be coupled to the port of the multi-port connector that the visualization device is inserted within to provide compression of the visualization device within the catheter. In one embodiment, the compression member comprises a flexible diaphragm, gasket, O-ring and/or other seal member configured to receive the catheter. The diaphragm or other seal member may be configured to seal or otherwise close down around and conform to an outer diameter of the catheter. The compression member may be configured to exert a compressive force on the catheter to inhibit axial or rotational movement of the catheter once the catheter is in a desired position. The retention assembly may comprise a retention member configured to engage with or couple to a corresponding member on the visualization device (e.g., a notch, slot, groove, recess, protrusion, ring, detent, loop, adhesive member) and an elastomeric sleeve configured to stretch to facilitate engagement with the corresponding member and exert a returning force as a result of the tendency to return to a relaxed, non-stretched state.
In accordance with several embodiments, a method for selectively blocking respiratory air flow through an endotracheal tube to one of a patient's lungs is provided. In one embodiment, the method comprises providing an endobronchial blocker such as the endobronchial blockers described herein. In one embodiment, the method comprises coupling an endotracheal tube adapter having at least two inlet ports to an endotracheal tube within an intubated patient and inserting a visualization device within the central lumen of the endobronchial blocker. In one embodiment, the method comprises advancing a distal end of the visualization device to the distal end of the endobronchial blocker.
In one embodiment, the method comprises inserting the endobronchial blocker within a first inlet port of the two inlet ports and causing the retention assembly to exert the force on the visualization device by coupling a retention member of the retention assembly to the visualization device. In one embodiment, the method comprises advancing the distal end of the endobronchial blocker within one of the lungs of the patient. The method may comprise confirming the positioning of the distal end of the endobronchial blocker using the visualization device. In one embodiment, the method comprises uncoupling the visualization device from the retention assembly and withdrawing the visualization device past a proximal end of the inflatable balloon of the endobronchial blocker. In one embodiment, the method comprises inflating the inflatable balloon to occlude the lung or portion thereof and confirming proper inflation and positioning of the inflatable balloon using the visualization device.
In some embodiments, the method comprises coupling a ventilator to a second inlet port of the two inlet ports. The method may comprise recording an image of the position of the inflatable balloon within a bronchus. In one embodiment, the method comprises aspirating the airway beyond the inflatable balloon through a second channel within the wall of the catheter and/or insufflating the airway beyond the inflatable balloon through a second channel within the wall of the catheter.
In some embodiments, the method comprises inserting a suction catheter through a third inlet port of the endotracheal tube adapter. In one embodiment, the method comprises inserting a fiberoptic bronchoscope through a third inlet port of the endotracheal tube adapter. In accordance with several embodiments, the method is performed without obstruction of the endotracheal tube or other body-inserted tube. In some embodiments, the method comprises coupling a compression member to the catheter configured to exert a compressive force on the catheter to inhibit axial or rotational movement of the catheter once the catheter is in a desired position. In various embodiments of methods, certain steps may be performed in a different order and/or may be optional.
For purposes of summarizing the disclosure, certain aspects, advantages and novel features of embodiments of the inventions have been described herein. It is to be understood that not necessarily all such advantages can be achieved in accordance with any particular embodiment of the inventions disclosed herein. Thus, the embodiments disclosed herein can be embodied or carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as can be taught or suggested herein.
The methods summarized above and set forth in further detail below describe certain actions taken by a practitioner; however, it should be understood that they can also include the instruction of those actions by another party. For example, actions such as “inflating a balloon” include “instructing the inflating of a balloon.” Further aspects of embodiments of the invention will be discussed in the following portions of the specification. With respect to the drawings, elements from one figure may be combined with elements from the other figures.
Several embodiments of the inventions disclosed herein will be more fully understood by reference to the following drawings which are for illustrative purposes only:
The second port of the tri-port connector 100 is a main manifold port 106, which may also optionally include a cap 107. The main manifold port 106 can be configured to receive an intubation and/or cleaning system having visualization or imaging capabilities or functions (such as, for example, components of the visualization devices 120 or visualization device assembly 2521 or cleaning systems described in WIPO Publ. No. WO 2013/063520, the entire content of which is incorporated herein by reference) and/or a cap-insert configured to allow suctioning, fiberoptic bronchoscopy or endoscopy, or other instrumentation of the tracheobronchial tree or other anatomical features during an operation or procedure.
In some embodiments, the third port of the tri-port connector 101 comprises a manifold port 108 through which a stylet (e.g., malleable stylet), obturator or other device can be placed (for example, at the time of intubation). The manifold port 108 can optionally include a cap 109 or similar seal member. In some embodiments, the tri-port connector 100 further includes a universal connection port 111 that connects the tri-port connector 100 to the proximal portion of standard endotracheal tubes or other medical tubes (e.g., tracheostomy tubes). As shown, the tri-port connector 100 may include one-way valves 110 (e.g., “duckbill” valves or flap valves), diaphragms, seals or other flow (e.g., backflow) prevention members that maintain positive pressure within the main manifold 104 (and ventilator circuit) when no devices are in place through the valves 110.
Once a visualization device (e.g., scope) has been used to appropriately direct and place the endobronchial blocker 120 at a location within a tracheobronchial location (e.g., within a bronchus of a lung) or other anatomical location, the visualization device is uncoupled from the retention member 135 and pulled backward until appropriate visual identification and confirmation of balloon position of an occluding balloon of the endobronchial blocker (e.g., balloon 142 shown in
The window 141 can have a thickness of less than about 0.012 inches (for example, 0.001 inches, 0.002 inches, 0.003 inches, 0.004 inches, 0.005 inches, 0.006 inches, 0.007 inches, 0.008 inches, 0.009 inches, 0.010 inches, 0.011 inches, 0.012 inches, etc.). In one embodiment, the thickness of the window is about 0.005 inches. In some embodiments, the thickness of the window does not exceed about 0.008 inches. The window injection mold can be highly polished (e.g., with an SPE #1 finish and/or optical finish) or otherwise treated in order to ensure optical clarity of the molded parts. In some embodiments, the lens 147 of the visualization scope 140 is indented by a few thousandths of an inch (e.g., about 0.001 to about 0.004 inches) in order to prevent or reduce the likelihood of scratches and damage to the lens.
In
In accordance with several embodiments, the endobronchial blocker 120 can be inserted within the tri-port connector 100 after performing a routine intubation. In accordance with several embodiments, the intubation may be facilitated through the use of a visualization or imaging system, such as one or more of the visualization systems described in WIPO Publication Number WO 2013/063520, the entire content of which is incorporated herein by reference, which may be used to confirm proper positioning of placement of a distal end of an endotracheal tube during intubation of a patient using direct visualization. In some embodiments, a patient is anesthetized and intubated with a single-lumen endotracheal tube or other body-inserted medical tube according to clinician preference, and the endotracheal tube is secured to the patient. In various embodiments, the lumen of the endotracheal tube is from 5 mm to 9 mm.
In some embodiments, the tri-port connector 100 is inserted between the endotracheal tube and a ventilator, with the ventilator connected to a ventilator port of the tri-port connector 100 and the endotracheal tube connected to the universal connection port 111. In some embodiments, the endobronchial blocker 120 is inserted through the stylet port (e.g., manifold port 108) of the tri-port connector 100 and advanced distally through the endotracheal tube. In some embodiments, with the assistance of visualization provided by the camera at the tip of the endobronchial blocker 120 behind an optically clear window 141, the images of which are displayed on a monitor, the distal end of the endobronchial blocker 120 is directed into the chosen bronchus for occlusion. The monitor or a storage device coupled to the monitor can store video or still images obtained and/or transmit the images to a remote location. Steering may be provided by slight angulation near the tip of the endobronchial blocker 120. Visualization on the compatible monitor can also allow for confirmation of placement of the distal tip of the endotracheal tube.
In some embodiments, a camera or other imaging device at the distal end of the visualization scope 140 may then be withdrawn proximally to the origin of the balloon 142 and the balloon 142 may be inflated under direct vision to be certain that it inflates appropriately and in the correct position. Tracheobronchial landmarks, such as the carina and non-occluded bronchus or bronchi, can be easily viewed through a transparent or substantially transparent catheter portion 121 proximal to the origin of the occluding balloon 142.
Continuously or intermittently (e.g., at certain times during the procedure), the position of the balloon 142 can be easily confirmed and adjusted as desired or necessary, as the visualization scope 140 remains in place in the catheter portion 121 of the endobronchial blocker 120 throughout the duration of the operative procedure. In some embodiments, once the procedure or treatment has been completed, the balloon 142 is deflated and the endobronchial blocker 120 is removed.
The materials used for the various components of the connectors and endobronchial blockers described herein can advantageously comprise one or more biocompatible materials. Such materials can be rigid or semi-rigid and/or flexible, as desired or required for a particular application or use. The materials used can include, but are not limited to, polyether ether ketone (PEEK), Nylon 6/6, polyethylene, polypropylene, polyethylene terephthalate (PET), glycol-modified PET, polyvinyl chloride (PVC), thermoplastic elastomers (TPEs) such as PEBAX TPEs, other natural or synthetic polymers (e.g., KRATON polymers), silicone, natural rubber, latex, polycarbonate, K resin, acrylonitrile butadiene styrene (ABS), styrenes and/or other thermoplastic elastomers or polymers. The caps disclosed herein may be tethered or non-tethered. In various embodiments, the removable caps may be configured to be coupled via threaded coupling, snap-fit coupling, friction-fit coupling and/or any other type of connection device or method. The diaphragms or other seal member may be configured to seal or otherwise close down around and conform to an outer diameter of the devices inserted therethrough.
While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “inflating a balloon” include “instructing the inflating of a balloon.”
Various embodiments of the invention have been presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. The ranges disclosed herein encompass any and all overlap, sub-ranges, and combinations thereof, as well as individual numerical values within that range. For example, description of a range such as from 70 to 115 degrees should be considered to have specifically disclosed subranges such as from 70 to 80 degrees, from 70 to 100 degrees, from 70 to 110 degrees, from 80 to 100 degrees etc., as well as individual numbers within that range, for example, 70, 80, 90, 95, 100, 70.5, 90.5 and any whole and partial increments therebetween. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “about” or “approximately” include the recited numbers. For example, “about 10%” includes “10%.” For example, the terms “approximately”, “about”, and “substantially” as used herein represent an amount close to the stated amount that still performs a desired function or achieves a desired result.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US14/59247 | 10/6/2014 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 61887814 | Oct 2013 | US |
