HK1236449A1 - Combined laryngo-tracheal anesthetic and stylet device - Google Patents

Description

Combined laryngotracheal anesthetic and stylet device

The applicant: joshua j.herskovic, m.d.

Priority

This PCT application claims the benefit of U.S. patent application No. 14/301,170, filed 6/10 2014, the entire contents of which are incorporated herein by reference.

Background

1. Field of the invention

The present invention relates to a method and apparatus for anesthesia and intubation, and more particularly, to a method and apparatus for anesthesia and intubation of a patient with a single-handed movement.

2. Background of the invention

Laryngotracheal anesthesia (LTA) is an important component of anesthesia programs related to general anesthesia performed during surgery. LTA blunts tracheal reflex action and discomfort involved in manipulating the trachea for surgery, and helps to place and hold the endotracheal tube (ETT). About one third of the approximately 1500 million general anesthetics requiring ETT performed each year will require the use of LTA.

Laryngotracheal anesthesia is typically administered just prior to placement of the endotracheal tube. Typically, the anaesthetist visualizes the vocal cords through direct laryngoscope detection, places an intubation tube connected to a syringe containing local anesthetic through the vocal cords, and injects the local anesthetic into the trachea and oropharynx. In the next direct laryngoscope examination, the anesthesiologist places the endotracheal tube through the vocal cords and into the trachea by sliding the ETT over a guide wire (often referred to herein as a stylet) or, in some cases, over an inserter.

These two or more separate steps potentially interfere with the anesthesiologist who must first reach out to access the LTA device and then reach out to access the ETT. The act of direct laryngoscope detection also places a significant strain on the patient. Placement of a laryngoscope blade on or near the epiglottis causes excessive sympathetic reflex (and concomitant blood pressure float) because of the extremely high neural sensitivity in this region. Many patients, such as those with heart disease, cannot tolerate the large amplitude of blood pressure and heart rate fluctuations that occur with the multiple actions of direct laryngoscope detection.

In addition, long term direct laryngoscope testing poses a greater risk to the patient. The best view of the vocal cords was obtained when the first attempt was made to direct laryngoscope examination. Prolonged direct laryngoscope detection results in increased edema, tissue trauma, bleeding and secretions, all of which detract from the view of the vocal cords when the ETT is to be placed. The actual injection of LTA fluid also hampers the view. During this period, the trachea is unprotected and the risk of aspiration increases. Moreover, sometimes the irritation caused by the placement of LTA in patients with incomplete paralysis may cause reflex spasms of the vocal cords, thus completely preventing the placement of ETT.

During operation of the device, the "top heavy" intubation device is often accidentally traumatic to the patient's eyes and face when loaded into the endotracheal tube.

Attempts have been made to implement LTA by ETT. However, these devices require extreme dexterity as the anaesthetist must change the hand position many times to deliver the LTA and place the ETT. For example, the anesthesiologist uses one hand position to initially approach the vocal cords, another hand position to dispense anesthetic, and another hand position to advance the ETT. Changing hand positions is more complicated because the anesthesiologist must hold the laryngoscope blade with one dedicated hand. Thus, these expected benefits of reducing direct laryngoscope detection time and less invasive experience for the patient are largely lost. Indeed, the greatest challenge with such combined stylet and LTA devices is the ability to perform the intended function of the LTA without increasing the level of difficulty, dexterity, and technique currently required to deliver LTA (all without increasing the in situ movement of the device).

There is a need in the art for the following methods and systems: allowing injection of local anesthetic while maintaining the ETT in the correct position for intubation. The method and system should reduce the difficulty of intubating a patient by functioning as an introducer or "bougie". Also, the device should not add much weight and bulk to the top of the tube inside the trachea.

Disclosure of Invention

It is an object of the present invention to ameliorate the limitations of the prior art LTA devices.

It is another object of the present invention to provide LTA devices that also function as stylets and introducers during intubation. It is a feature of the present invention that the LTA device has a reversibly deformable (e.g., malleable) catheter that can be bent and can maintain its shape to guide the ETT during intubation. An additional feature is that pre-shaped catheters may also be used with the device of the present invention. It is another feature of the invention that the nozzle at the distal end of the LTA device extends beyond the end of the ETT and serves as an introducer. An advantage of the present invention is that the means for supplying anesthetic and directing ETT are combined into a single device that can be used simultaneously with ETT placed in the trachea.

It is a further object of the present invention to provide an LTA device that can be used during ETT placement without increasing the skill and dexterity of the user. The invention features a physically activated feature (e.g., lever, trigger, key) or non-physically activated feature (e.g., audio or electronic signal) that causes the anesthetic or other medication to exit the reservoir, the physically activated feature being placed near an area of the device adapted to be grasped by a hand of a user. An advantage of the present invention is that the device allows an anesthesiologist to deliver a dose of anesthetic during intubation without the need to change the position of the hands and without the need for both hands.

It is another object of the invention to provide a method that reduces the overall time involved in performing direct laryngoscope testing. It is a feature of the present invention to use the LTA device to function as both a component of the trachea and posterior pharynx of anesthetized patients and as a stylet and introducer for the placement of ETTs. The advantages of the present invention are that there is no need for separate direct laryngoscope detection with regard to LTA and ETT placement; alternatively, the method combines these two functions such that they occur simultaneously or within a few seconds (about one to 10 seconds, and preferably within about 3-6 seconds, and most preferably less than 5 seconds from each other). Another advantage is that potential injury and stress to the patient through repeated procedures is eliminated. Yet another advantage is that the risk of liability (liabityexposure) for the anesthesiologist is thus reduced.

It is another object of the present invention to provide an LTA device that is modular in design. It is a feature of certain embodiments of the invention that the flexible catheter, dispenser and anesthetic cartridge can be easily assembled using luer connectors (luer connectors). An advantage of the present invention is that components can be replaced or sterilized when needed without replacing the entire device. Alternatively, the entire device may be made disposable. Another advantage of the present invention is that the same introducer or dispenser system can be used on two different LTA medical device designs, even as a device for administering drugs in a non-intubating scenario. This allows for lower manufacturing costs and reduced hospital investment in both platforms.

Briefly, the present invention provides a laryngotracheal anesthesia device comprising: a catheter having a first end and a second end, wherein the second end is designed for entry of a component for pressurizing anesthetic into a patient, wherein the component is adapted for receiving an anesthetic cartridge; means for releasing anesthetic from the reservoir into the flexible tube; and a nozzle at a second end of the flexible tube.

The present invention also provides a device for pressurizing an anesthetic cartridge on an intravenous line, the device comprising: a housing having a first end and a second end, wherein the first end of the housing is open and the second end of the housing is a flat base, and wherein the housing is adapted to receive a vial of anesthetic inserted with a stopper; a piston extending from the planar base, wherein the piston exerts pressure on the vial stopper; a needle that pierces the stopper and provides fluid communication with the interior of the vial, and wherein the needle defines a channel through the piston and through the planar base; a luer connector in fluid communication with the passageway defined by the needle; and a variable flow regulator in fluid communication with the luer connector, wherein the variable flow regulator is adapted to receive an intravenous catheter.

Brief description of the drawings

The invention, together with the above and other objects and advantages, will best be understood from the following detailed description of a preferred embodiment of the invention when read in conjunction with the accompanying drawings, wherein:

fig. 1 is a depiction of a vial embodiment of an LTA device in accordance with features of the present invention;

FIG. 2 is a depiction of the device of FIG. 1 when held in the correct position by an anesthesiologist;

FIG. 3A is a cross-sectional view of the dispenser portion of the device taken along line 3-3 of FIG. 1;

3B-3C depict detailed views of a valve according to features of the present invention;

4A-4B depict vials loaded into the device of FIG. 1 in accordance with features of the present invention;

FIG. 5A depicts an alternative vial embodiment of a pre-loaded device in accordance with features of the present invention;

FIG. 5B depicts the embodiment of FIG. 5A in a post-load configuration;

FIG. 5C depicts a cross-sectional view of the device taken along line C-C in FIG. 5A;

FIG. 5D depicts a cross-sectional view of the device taken along line D-D in FIG. 5B;

6A-6C depict vial embodiments with a piston within the vial in accordance with features of the present invention;

7A-7B depict another vial embodiment having two non-return valves in accordance with features of the present invention;

fig. 8A-8D depict syringe embodiments of LTA devices according to features of the present invention;

FIG. 8E depicts a gas pressurizing injector embodiment in accordance with features of the present invention;

FIG. 9A is a cross-sectional view of FIG. 8E taken along line 9A-9A;

9B-9C depict cross-sectional views taken along line 9B-8B as shown in FIG. 9A;

FIG. 10A depicts an embodiment of a reservoir without a one-way valve in accordance with features of the present invention;

10B-10C depict a locking syringe embodiment of a device according to features of the present invention;

11A-11B depict embodiments of syringes having internal springs in accordance with features of the present invention;

FIG. 12 depicts an embodiment of an LTA device having a link mechanism in accordance with features of the present invention;

13A-13D depict embodiments of LTA devices having ejection mechanisms in accordance with features of the present invention;

FIG. 14 depicts an embodiment of an LTA device having a coaxial motor controlled by an actuation member on a direct laryngoscope blade;

15A-15B depict a tab on the actuation member that facilitates removal of the stylet from the ETT in accordance with features of the present invention;

16A-16B depict embodiments of nozzles of devices according to features of the present invention;

FIG. 17A depicts another embodiment of a nozzle of an apparatus according to features of the present invention;

FIG. 17B depicts a cross-sectional view taken along line A-A in FIG. 17A;

18-20 depict additional embodiments of nozzles;

FIG. 21 depicts an exploded view of an intravenous dispensing apparatus, in accordance with features of the present invention; and is

Fig. 22A-22B depict an intravenous dispensing device as applied to a nerve block procedure.

Detailed Description

The foregoing summary, as well as the following detailed description of certain embodiments of the present invention, will be better understood when read in conjunction with the appended drawings.

As used herein, an element step in the singular and proceeded with the word "a" or "an" should not be understood as excluding plural said elements or steps, unless such exclusion is explicitly recited. Furthermore, references to "one embodiment" of the present invention are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features. Furthermore, unless explicitly stated to the contrary, embodiments "comprising" or "having" an element or a plurality of elements having a particular property may include other such elements not having that property.

The present invention is an apparatus for administering a medicament, such as a laryngotracheal anesthetic. The present invention provides a device and method for administering medication in inaccessible locations, such as lumens.

As depicted in fig. 1, the LTA device 10 defines an elongated body generally comprised of a distributor 15 in fluid communication with a conduit 20. The distal end of the conduit terminates in a nozzle 25. The dispenser 15, upon actuation via the actuation member 30, dispenses anesthetic through the conduit 20 and from the nozzle 25. The actuating member 30 is located intermediate the dispenser 15 and the nozzle 25. The actuating member in the illustrated embodiment is a lever in pivotal communication with the distal end of the dispenser. The distal end of the lever is actuated by a user with a medially or laterally directed force. In an embodiment of the invention, the longitudinal axis of each of the distributor, the conduit and the nozzle is coaxial.

The LTA device not only provides anesthetic during intubation, but also serves as a tool to aid in the placement of ETTs during dispensing of anesthetic and more generally as a means for direct administration of drugs. Accordingly, fig. 2 depicts in phantom the LTA device 10 substantially enclosed within (or substantially encapsulated by) the ETT 31 prior to intubation. The ETT 31 basically includes a proximal end 31p, a distal end 31d, a balloon envelope 32 adjacent the distal end 31d, an envelope inflator 33, and a guide tube 34 having a first or proximal end terminating in the inflator and a distal end in fluid communication with the interior region of the envelope 32. In an embodiment of the present invention, the proximal end of the catheter 34 is adapted to receive a heated or cold fluid to allow the envelope to be similarly heated or cooled once placed within the trachea. This feature would provide a means for heat treating the trachea to minimize dilation or improve friction during the intubation procedure while allowing the patient to be intubated for a longer period of time. More typically, the cuff 32 is inflated with air in the trachea to stabilize the ETT and prevent aspiration. The envelope blower 33 is pumped or otherwise actuated to force air through the guide tube 34 into the envelope 32.

Upon placement of the LTA device 10 in the ETT 31, the malleable (e.g., reversibly deformable) catheter 20 functions as a stylet such that it can be reversibly shaped to aid in the placement of the endotracheal tube. In addition, the nozzle 25 extends past the distal end of the endotracheal tube and serves as a bougie or introducer as it can guide the LTA device 10 and ETT 31 through the patient's epiglottis and glottis during intubation.

The LTA device 10 allows an anesthesiologist to provide these functions while also maintaining the skill and dexterity level of normal intubation. For example, the anesthesiologist may administer a dose of anesthetic without having to remove his hands from the correct hand positions depicted in FIG. 2. In this position, the anesthesiologist positions the device between his thumb and index finger such that the device is supported by the middle phalanx of the index finger and the distal phalanx of either the two or middle finger. The anesthetic dispensing actuation member (such as the lever shown in fig. 1) is actuated by the distal phalanx of the index finger. Furthermore, after completion of intubation, the actuation member or lever provides an additional function for assisting in the removal of the stylet and introducer device from the ETT. The lever provides leverage against the static friction between the stylet and the ETT to assist in removing the stylet from the ETT.

Dispenser details-vial embodiments

Although the following discussion of the dispenser refers to a laryngotracheal anesthetic device that may also be used as an adjunct in intubation procedures, the dispenser may be used for many other purposes. For example, the dispenser may be part of a stand-alone LTA device that can pass through the ETT, including a pediatric ETT, or an LTA through which the ETT passes. In addition, as discussed below, the dispenser may be used to deliver controlled doses of medication through an IV, and it allows nerve blockade to be performed more easily. In short, the dispenser portion of the device can be used in many applications and in many contexts.

The distributor 15 is present in many embodiments. In each embodiment, the dispenser 15 is adapted to receive an anesthetic cartridge or ampoule. When actuated by the actuating member 30, the dispenser 15 releases the contents of the cartridge for dispensing through the conduit 20 and out the nozzle 25. However, the means for pressurizing the contents and the actuating means vary between the following embodiments.

In the primary embodiment shown in fig. 3A-3C, the dispenser 15 includes a housing 35 defined by a first (or proximal) end 40, a second end 45, and a longitudinally extending peripheral wall 50. Toward the second end 45 is a planar base 55. The piston 60 extends proximally from the planar base 55. A needle 65 extends coaxially and proximally from the piston 60 such that the needle extends toward the first end 40 of the housing. The needle 65 defines a fluid pathway that extends from a tip 65t of the needle, through the piston 60, and through the first base 55. This fluid passageway is in fluid communication with the interior chamber defined by the conduit 20.

In operation, a user provides an anesthetic cartridge (in this embodiment, vial 70 with stopper 72). The process of loading vial 70 is depicted in fig. 4A-4B. The cross-sections of the vial 70 and the housing 35 are such that the housing is adapted for slidably receiving the vial, whereby the longitudinal axes of the housing and the vial are collinear. The user loads vial 70 into housing 35, sliding vial 70 in the direction of planar base 55, as shown by the arrow in fig. 4A. Under pressure applied by the user, the needle 65 pierces the stopper 72, thereby providing fluid communication between the LTA device 10 and the contents of the vial 70. As the user continues to apply pressure to vial 70, stopper 72 contacts piston 60, thereby driving piston head 75 toward planar base 55. The vial 70 is then locked in place by a tab 77 or cap at the first end 40 of the housing 35. Once tab 77 engages vial 70, the user stops applying pressure to vial 70. A small space separates the distal end 70d of the vial 70 from the flat base 55 to provide space for compressing the piston 60, particularly when the piston 60 is spring loaded.

The tabs 77 are tapered protrusions that terminate in a hook shape; this allows the vial 70 to slide beyond the housing 35 when loaded but prevents the vial 70 from sliding out of the housing under the force of the piston 60. In one embodiment, tab 77 is a cantilevered snap fitting. Insertion of vial 70 creates a flexible load on the protrusion until the vial slides past the hook and hangs on the depression below the hook. At this point, the protrusion returns to a nearly unstressed state while preventing reverse movement of the drug vial.

Upon loading, the contents of vial 70 become pressurized due to the pressure exerted by compressed piston 60. The piston 60 exerts a positive pressure on the stopper 72, which in turn exerts pressure on the contents of the vial 70. The pressurized contents are expelled through the needle 65 (which is in fluid communication with the catheter 20), but have not yet been able to flow through the catheter. When the contents are allowed to drain, the fluid pressure on stopper 72 decreases (opposite piston 60) and piston 60 extends away from flat base 55, causing stopper 72 to move toward proximal end 70p of vial 70. Thus, the piston 60 exerts a continuous positive pressure on the contents of the vial 70.

Returning to fig. 3A-3C, the piston 60 depicted therein is spring loaded. As previously discussed, inserting vial 70 into housing 35 compresses piston 60. However, the spring may also be pre-compressed to facilitate loading of the vial. In this way, the user locks the vial 70 in place by the tab 77 and then releases the snap on the compressed spring to cause the piston 60 to contact the stopper 72, thereby pressurizing the vial 70.

In another embodiment depicted in fig. 5A-5D, air is compressed in a compression chamber between the piston 60 and the flat base 55 during loading of the vial 70. A needle 65 passes through the center of the piston 60 to allow liquid from the vial 70 to enter the compression chamber.

Fig. 5A and 5C depict vial 70 and device 10. The user loads the vial 70 by pressing the vial 70 onto the piston 60. Optionally, and as can be seen in fig. 5A and 5C, the piston 60 includes a rigid sheath portion 60a to surround the needle 65 to avoid accidental needle sticks. The needle 65 engages the vial stopper 72. As vial 70 is loaded, piston 60 moves toward flat base 55, thereby compressing the air in the compression chamber. In addition, the pressure of the piston 60 on the plug 72 forces liquid through the needle 65 into the compression chamber. Thus, the air in the compression chamber is pressurized by a reduction in volume caused both by the movement of the piston and by filling the chamber with liquid. Preferably, the user loads vial 70 until stopper 72 pushes substantially all of the liquid out of vial 70, as shown in fig. 5B and 5D, so that the vial is substantially empty. This creates maximum pressure and allows the entire contents of vial 70 to be dispensed. The compressed air is used to drive the liquid when the actuation member 30 is triggered. In this embodiment, the entire volume of air in the piston chamber is compressed during vial loading. Fluid is released from the compression chamber to the downstream components of the device 10 through the through passage 93 (fig. 5C and 5D).

(however, in embodiments of the invention, not all of the contents of the vial are emptied at the same time

The piston chamber is made airtight, ensuring that the maximum amount of pressure is applied to the air in the chamber. To provide a gas-tight seal, the piston 60 has a bottom 60b, which is surrounded by a sealing member 91. The sealing member 91 may be a separate component, such as an O-ring, or the sealing member 91 may be an integrally molded gasket.

In this embodiment, the vial may be configured as a cartridge to facilitate loading. Instead of the tabs 77 on the upper region of the housing 35, the vial is adapted to have ridges 78 along one or more sides thereof. The housing 35 itself has one or more locking arms 79. The ridge 78 and locking arm 79 can be seen in fig. 5A. The ridges 78 are angled such that when the vial or cartridge 70 is pushed downwardly, the locking arms 79 slide outwardly beyond each ridge 78. The locking arms 79 then spring inwardly over the ridge 78 to prevent the vial 70 from being ejected by the increasing air pressure. Although the ridge 78 and locking arm 79 may be substituted for the tab 77, the tab 77 may be used with this embodiment, including in combination with the ridge 78 and locking arm 79.

The locking arm 79 may also serve to retain the piston 60 in the housing 35, i.e., to keep the piston 60 from being accidentally withdrawn completely from the housing 35. Alternatively, the inner surface of the housing 35 may have a protrusion extending in the middle to keep the piston 60 from being completely withdrawn from the housing 35. The projection may be around the entire inner circumference of the housing or only a portion of that circumference.

In yet another embodiment, the piston 60 may also be pneumatically, hydraulically or electrically actuated. For example, the piston 60 may be a magnetic shaft of a linear shaft motor. The piston 60 may also be a pneumatic actuator. The device 10 will require compressed air to operate, but medical air compressors are common, particularly for use in dental offices. Alternatively, the piston may be a rod of a hydraulic cylinder. Similar to the pneumatic embodiment, the hydraulic embodiment would require a reservoir of hydraulic fluid and a pump to work; however, various sizes of these articles and for various applications are common.

Intermediate the planar base 55 and the conduit 20 is a valve 80. The valve 80 is in mechanical communication with the actuation member 30. As depicted in fig. 1, the actuation means 30 is a pendant lever, button, trigger or audio prompt that remotely actuates the device via bluetooth, infrared, radio frequency or other electronic transmission means. When the user engages the actuation member 30, the valve 80 is opened and the contents of the vial 70 may flow into the catheter 20 through the needle 65.

Fig. 3B depicts a cross-sectional view of the valve 80. The valve 80 defines a valve cavity 81 that houses a valve plunger 82. Valve plunger 82 has a proximal end 82p and a distal end 82d, and proximal end 82p is in mechanical communication with actuation member 30. A valve plunger 82 is slidably received into the valve cavity 81 through an orifice 83. Fluid is prevented from escaping the valve chamber by the first O-ring 84 a. The distal end 82d of the valve plunger 82 includes two flanges 85a, 85b sandwiching a second O-ring 84 b. The flanges 85a, 85b and the second O-ring 84b have diameters such that they block fluid flow to a downstream portion of the valve chamber 81. The downstream portion of the valve chamber 81 contains an outlet 86 which is in fluid communication with the conduit 20.

As can be seen in fig. 3B, prior to actuation, valve 80 blocks fluid flow between needle 65 and outlet 86. As shown in fig. 3C, actuation causes flanges 85a, 85b and second O-ring 84b to slide beyond outlet 86, thereby allowing fluid communication between needle 65 and catheter 20 as illustrated with flow arrows. When the user removes pressure from the actuation member 30, the plunger is pulled back to its original position by the spring 87. A bonnet 88 is placed at the end of the valve opposite the spring 87. The bonnet 88 prevents fluid from the valve from escaping. Other obstructions, plugs or obstructions may also be used to halt flow from within the valve.

Because of the positioning of outlet 86, the outlet is bent at an angle of approximately 45 ° to establish communication between needle 65 and the catheter. The region 89 proximal to the outlet 86 does not provide fluid communication with the catheter. The primary purpose of this region 89 is to provide a larger diameter to which the ETT is attached. Region 89 also promotes the sense of stability in the hands of the anesthesiologist.

Fig. 1 shows an actuation member 30, which is a lever or trigger. As depicted in fig. 3, the actuation member 30 terminates at its proximal end in a fulcrum 90 that is in rotatable communication with the exterior surface of the dispenser housing 35. A valve actuation point 92, which includes the rigid base 82 (hereinafter referred to as the valve plunger) positioned at approximately 90 degrees to the longitudinal axis of the housing, is disposed in spaced relation to the fulcrum 90 and thus in distal relationship on the actuation member 30. The plunger 82 has a first end rotatably attached to the actuation member 30 and a second end projecting medially and contacting the valve 80. Here, in the valve 80, a valve plunger 82 is connected to the actuating member 30. In this manner, when a user applies a medially directed force to the actuation member 30, the valve plunger 82 is depressed and the valve is opened. As long as the user continues to apply force to the actuation member, the LTA device 10 will provide a spray of anesthetic.

As with the piston 60, the valve plunger 82 may also be pneumatically, hydraulically, or electrically actuated. Devices such as linear motors, solenoid valves, pneumatic actuators, and hydraulic cylinders may drive plunger 82, thereby pushing flanges 85a, 85b and second O-ring 84a beyond outlet 86.

In another embodiment, the piston 60 is not positioned in the housing 35. Alternatively, the piston is positioned in vial 70, as shown in fig. 6A. Distal end 70d of vial 70 has a cap 94 that retains the liquid and piston 60 within the vial. The piston 60 is a compression spring mounted to the cap 94. Rubber plug 72 defines a piston head. In addition, the cap 94 is preferably pierceable so that the needle 65 in the housing can pierce the cap 94 during insertion and filling of the vial. When liquid is added to the vial, the fluid pressure pushes the piston in the distal direction 60 towards the cap 94. The piston 60 exerts a continuous positive pressure on the fluid as it is dispensed from the vial 70, thereby maintaining compression. Figure 6B shows this embodiment when the vial is first loaded. As can be seen, the spring is fully compressed. Fig. 6C depicts the empty vial with the piston fully extended.

In yet another embodiment, the housing 35 does not contain a piston 60, such that the housing is pistonless. Alternatively, the fluid pressure created during filling of valve cavity 81 provides a means for withdrawing fluid from vial 70. As in the previous embodiment, the user loads the drug vial 70 into the housing 35 with the needle 65 piercing the rubber vial stopper 72. A static ram 95 extending from flat base 55 pushes against stopper 72 when loaded, causing fluid in vial 70 to fill needle 65 and valve cavity 81. In this embodiment, when the vial 70 is fully loaded, the distal end 70d of the vial 70 contacts the flat base 55 and the tab 77 at the proximal end 35p of the housing 35 locks the vial 70 in place. Within the static ram 95 is a first check valve 96 a. As depicted in fig. 7A, the first non-return valve 96a is a ball valve. During loading, the first non-return valve 96a opens due to the fluid pressure on the ball, which is generated by the pressure exerted on the plug 72 by the static ram 95. Since the first check valve 96a is opened, the fluid flows into the valve chamber 81. The volumetric expansion from the needle 65 to the valve chamber 81 reduces the fluid pressure. Within outlet 86 is a second non-return valve 96 b. This valve is initially closed because the fluid pressure is not great enough to open the valve.

Upon depression of the actuation member 30 (fig. 7B), the valve plunger 82 causes the valve spring 87 to compress, wherein the pressure in the valve chamber increases due to the reduction in volume. The increased pressure forces first check valve 96a to close and opens second check valve 96 b. Thus, reverse flow into vial 70 is prevented and forward flow into conduit 20 is permitted.

When the actuation member 30 is released, the compressed valve spring 87 forces the valve plunger 82 out of the valve cavity 81, wherein a pressure drop in the valve cavity 81 is caused. The reduced pressure or vacuum causes second check valve 96b to close, which also causes first check valve 96a to open. The vacuum in valve cavity 81 is then filled with fluid from vial 70. The action of filling the vacuum also pulls stopper 72 further toward proximal end 70p of vial 70 to equalize the pressure. This process is repeated each time the actuation member 30 is actuated until the contents of the vial 70 are completely expelled.

Although the above discussion primarily refers to a trigger as the actuation means, other actuation means are readily envisaged, in particular pneumatically, hydraulically, and electrically actuated embodiments. The actuating member 30 may be a foot pedal that controls a linear motor, air compressor or hydraulic pump in mechanical communication with the valve 80. Other suitable actuation components 30 include buttons, toggle switches, pressure sensors, or voice commands. Furthermore, these actuation components may be included on or separate from the device 10, as in the case of a foot pedal.

Syringe embodiments

In a second embodiment of the invention depicted in fig. 8A-8D, the dispenser 15 works in combination with a syringe 102. In some configurations of the second embodiment, the reservoir 100 is employed to pressurize fluid in the syringe 102. In other configurations, the syringe 102 is internally or externally pressurized and is directly connected to the pressure relief valve 104 (as shown in fig. 8A).

In configurations using the reservoir 100, the reservoir 100 is adapted to receive an anesthetic syringe as depicted in fig. 8A such that the reservoir is positioned between the syringe and the stylet 20. The reservoir defines a cavity isolated from the ambient environment. Syringe 102 is a typical syringe in that it includes a barrel 105, a plunger 110 slidably received by one end of the barrel, and a tip 115 positioned at a second end of the barrel. Some syringe embodiments also have finger tabs 117 that provide a means for applying pressure on the barrel 105 (as opposed to pressure applied to the plunger 110). The tip 115 of the syringe 102 is in fluid communication with the reservoir 100. In a preferred embodiment, tip 115 and reservoir 100 are connected via a luer fitting or luer lock. In a more preferred embodiment, the syringe 102 has a sealed tip and the mating surface of the reservoir has means for piercing the sealed tip when the tip is inserted into the inlet port of the reservoir. In this embodiment, the sealed tip and the mating surface have substantially the same cross-section to impart a hermetic seal between the two structures.

The luer fitting and luer lock establish a fluid tight seal between the lines or needles carrying the fluid. A luer connector consists of a male connector and a female connector. Both are frusto-conical fittings in which the female connector is adapted to receive the male connector. The standard connector for medical devices is about 6 percent. Some luer fittings have a gasket inside the female connector or outside the male connector to provide additional safety against slippage. A luer lock similarly consists of a tapered male and female connector. However, the male connector also has a threaded housing around its periphery. The female connector has a flange around the top of its fitting. Thus, when the male connector is received in the female connector, a flange on the female connector engages a threaded housing around the male connector to provide additional frictional engagement.

As can be seen in fig. 8C, upon attachment of the syringe 102 to the reservoir 100, the contents of the syringe 102 are injected into the reservoir 100 by depressing the plunger 110. As more clearly depicted in fig. 9A, the reservoir 100 has an inlet port 120 with a one-way valve 121 (depicted here as a ball valve) that allows the contents of the syringe to enter the reservoir but prevents the contents of the reservoir from returning back up into the syringe from which it came. In the preferred embodiment, the one-way valve 121 is a ball valve. Some commercially available luer lock adapters incorporate a one-way valve. These adapters are readily available in the medical field and are typically placed in-line (i.e., coaxially) between a standard syringe and an intravenous port to prevent the return of injected fluid into the syringe. In another preferred embodiment, these adapters are used instead of incorporating a one-way valve into the reservoir.

The ball valve 121 consists of a passage 122 defining a longitudinal axis along which a ball 124 moves back and forth. The spring 126 exerts a force on the ball 124 in the direction of the inlet port 120. (in this embodiment, the spring applies an axial force with respect to the channel.) the proximal end of the channel 122 defines a frustoconical surface adapted to matingly receive the ball to prevent backflow to the inlet port 120. The spring 126 is supported on a seat 130 which is itself formed by the depending end of the channel so that the seat is located between the fluid inlet apertures. When the anesthesiologist depresses plunger 110, the fluid pressure forces ball 124 to compress spring 126. As such, the inlet port 120 is no longer blocked and fluid may flow into the reservoir 100 through the passage 122. When the anesthesiologist removes pressure on the plunger 110, the spring 126 and elevated pressure in the reservoir push the ball 124 back into the inlet port 120, sealing it. In some embodiments, the spring 126 is omitted and only the elevated pressure in the reservoir pushes the ball to block fluid flow. The fluid remaining in the reservoir 100 is pressurized for dispensing.

The fluid is held in the reservoir 100 to be dispensed via the pressure relief valve 104. The reservoir 100 is a chamber having a peripheral wall 134 and a chamber floor 136. An outlet 138 is formed into the chamber floor 136. In certain embodiments, as depicted in fig. 9A, the chamber floor 136 is angled to flow the contents of the reservoir through a narrow space toward the outlet 138. The pressure relief valve 104 blocks flow through the outlet 138 until the valve is actuated via the actuating member 30.

As can be seen in fig. 8B-8C, relief valve 104 has a movable mass 140 within a valve chamber 141. The block defines the perimeter of two different surfaces. The first surface has a cross-section similar in shape but slightly smaller than the interior of the chamber so as to allow radial and medial movement of the block in the valve chamber such that the movement is generally perpendicular to the longitudinal axis of the chamber. This first surface surrounds approximately two thirds of the block. The second surface defines a chord intersecting the first surface. Along the middle of the chord and proximal to the chord edge, the region of the block defines a through-hole, such as a transverse orifice 142. There is a radially extending projection 144 approximately on the other side of the block and in the middle along the first surface. The protrusion 144 is matingly received by a port 146 formed in a side of the reservoir 100 such that a portion of the protrusion 144 is outside of the reservoir 100.

When relief valve 104 is at rest, spring 148 radially biases movable mass 140 to contact one side of valve chamber 141. In this rest position, the through-hole 142 and the outlet 134 are completely misaligned or overlapping; thus, no flow from the reservoir 100 occurs. When the anesthesiologist actuates the actuation member 30, the nubs 150 on the actuation member 30 contact the tabs 144 and push the tabs in a medial direction. In this way, the force input by the user on the actuation member 130 is transmitted to the movable block 140 through the nub 150. This action compresses the spring 148, forcing the block to move radially towards the centre of the chamber, allowing the through-hole 142 to align with the exit outlet 138. When the through-hole 142 and the outlet 134 are aligned, the pressurized fluid flows through the relief valve 104 and exits the reservoir through the opening 152. The opening 152 is in fluid communication with the flexible conduit 20.

Although the pressure relief valve is discussed as part of the primary embodiment. Other valves are also suitable. In certain embodiments, particularly those with electrically actuated components, the valve may be a solenoid valve. The solenoid valve is typically closed until electrically activated; thus, activation of the electrically actuated component also activates the solenoid valve. The solenoid valve may be electrically actuated via electrical current or wireless communication (e.g., infrared or radio frequency communication). Another possible valve is a pinch valve. Such valves may be activated electrically via electrical current or wireless communication (e.g., by radio frequency and infrared signals), or mechanically via pneumatic or hydraulic actuation. The pinch valve will be biased in the closed position to restrict flow through the soft and deformable passage between the reservoir or syringe and the conduit. Yet another potential valve is a multi-position valve. The multi-position valve remains closed until an open channel is selected by rotating to the flow path or unblocking the flow path. Such a valve would be particularly useful for embodiments of the present invention that apply continuous pressure to the plunger 110. This list of valve types is intended to be illustrative and not limiting; other valves may also be used as part of the present invention.

As depicted in fig. 8B-8D, the syringe 102 is attached to the reservoir 100. The plunger 110 is depressed, forcing the contents into the reservoir 100, where the contents become pressurized. Because the one-way valve blocks reflux, the syringe 102 can be removed. It is preferable to remove the syringe prior to intubating the patient, as the syringe may interfere with the view of the anesthesiologist during the intubation procedure. Moreover, the syringe adds additional weight to the tip of the ETT, thereby creating a device that is heavy at the tip that may hit the patient's face during intubation.

When the pressure relief valve is opened, fluid will flow out of the nozzle based on the pressure gradient existing between the pressurized vessel 100 and the nozzle 25 at ambient pressure. The one-way valve 121 prevents fluid from moving in the opposite direction out of the container 100 or back into the syringe (if the syringe is still connected). Since there is also a pressure difference between the chamber 100 under pressure and the ambient pressure or the pressure in the syringe, the valve 121 remains closed during this process. Alternatively, as shown in fig. 8E, a pressurized reservoir 153 of carbon dioxide or air may be attached to the reservoir 100 after the syringe 102 is removed. The pressurized fluid will ensure that the contents of the reservoir 100 remain pressurized throughout the intubation process. In another alternative design, the syringe or vial and pressurized gas reservoir are sold as a single pre-configured cartridge for pressurized delivery of anesthetic agent via the LTA device. Such cartridges are commercially available, such as from National Medical Products, Inc. (National Medical Products, Inc., California, Okawa)) Can be obtainedA needleless injection system.

In another configuration depicted in fig. 10A, the reservoir 100 does not employ a one-way valve 121. Alternatively, the syringe 102 or housing 160 has a locking mechanism 154, which can be seen in fig. 10B-10C. The anesthesiologist connects the syringe 102 to the inlet port 120. After fluid communication is established between the syringe 102 and the reservoir 100, the anesthesiologist depresses the plunger 110. A stop 156 on the plunger 110 engages a locking mechanism 154 mounted to the proximal end 105p of the barrel 105. As depicted in fig. 10B-10C, the locking mechanism 154 is two clips that extend vertically from the syringe 105. As the plunger 110 is depressed, the stop 156 deflects the tapered petals 158 on the clip away from the path of the plunger 110. Once the stop 156 passes the tapered petals 158, the clip returns to its original position and locks the syringe 102 in place.

Locking the syringe prevents fluid pressure from pushing the plunger 110 back toward the withdrawn position. Because the plunger 110 exerts a positive pressure on the contents of the syringe and the contents of the reservoir 100, no backflow of fluid occurs and the contents are pressurized for delivery. The delivery in this embodiment is similar to the previous embodiment (where the pressure relief valve 104 is activated by the actuating member 30).

In yet another configuration of the syringe embodiment, the syringe 102 is directly connected to the pressure relief valve 104. In this configuration, the contents of the syringe 102 are not pressurized in the reservoir. Alternatively, pressure is provided from within the syringe 102 or from an external force. In prior art devices, the anesthesiologist is forced to apply pressure to the syringe, but as such, the anesthesiologist is unable to keep his hands in the correct cannula position.

In one configuration depicted in fig. 11A, a dedicated syringe 102 is employed. In this embodiment, the syringe 105 of the injector houses a spring 130. One end of spring 130 is attached to the proximal end of barrel 105p, while a second end of spring 130 is attached to the distal end of plunger 110 d. As shown in fig. 11A, spring 130 is compressed when the distal end of plunger 110d is disposed spaced apart from the distal end of barrel 105 d. When the syringe is filled with anesthetic or another drug, fluid pressure holds plunger 110d in the withdrawn position. As fluid exits syringe 102, the fluid level in syringe 102 decreases, which allows spring 130 to depress plunger 110. Fig. 11B depicts the plunger fully depressed, with the spring substantially relaxed. Thus, compression of the spring 130 causes the plunger 110 to maintain a continuous pressure on the fluid in the syringe 102.

As described above, the syringe 102 is in fluid communication with the pressure relief valve via a luer lock (with or without a pierceable membrane). If the syringe is pre-filled with anesthetic or drug, the luer fitting preferably includes a pierceable membrane. Alternatively, if the syringe 102 is filled with an inhalation anesthetic or drug from a vial, the user would have to pull on the plunger 110 until the syringe 102 is connected to the pressure relief valve 104. Spring-loaded syringes are commercially available, such as the Episure (TM) AutoDetect LOR syringe distributed by Indigo Orb, Inc. (Santa Clara, Calif.).

The syringe 102 is in fluid communication with a pressure relief valve 104. Preferably, fluid communication is established via a luer lock or luer fitting; however, other sealing connections are also suitable. The pressure relief valve 104 operates in the same manner as in the other configurations and embodiments. The actuation member 30 is rotatably mounted to the housing 160. The housing 160 may be an outer wall of the pressure relief valve 104, or the housing 160 may extend over the pressure relief valve 104. As depicted in fig. 9B-9C, the actuation member 30 is in mechanical communication with a movable block 140 that includes a through hole 142. In this configuration, when the through-hole 142 is aligned with a luer lock, luer fitting, or other connection means, the contents of the syringe 102 may flow into the catheter 20.

In another configuration, a conventional syringe 102 is used and pressure is applied to the plunger 110 via the 4-bar linkage 155. As depicted in fig. 12, a rod 157 extends from the actuation member 30. Distal end 157d of rod 157 is connected to first link 159 via a first pivot joint 161 a. First link 159 is in turn connected to second link 163 via a second pivot joint 161 b. The second link 163 is connected to the plunger cap 165 via a third pivot joint 161 c. When the actuation member 30 or trigger is pulled, rotational movement of the trigger is transmitted to the linkage 155 through the rod 157. The distal end 157d of the stem 157 is rotated downward, as depicted by the arrow in fig. 12. This pulls the first link 159 toward the device 10, which translates into a downward pull on the second link 163. The second link 163 pulls the plunger cap 165 downward, which also forces the plunger 110 downward. Additionally, pulling the trigger actuates the pressure relief valve 104, whereby the contents of the syringe are released into the catheter 20.

As can be seen in fig. 13A, in another configuration, the ejection mechanism 167 is located on top of the plunger 110. The ejection mechanism 167 includes a plurality of springs 169 positioned on the bottom of the housing 160. Coaxial with the spring 169 is a vertical extension 170 that extends through the housing 160. The locking bar 171 is connected to two vertical extensions 170. A vertical arm 172 extends from the combination of the vertical extension 170 and the locking lever 171. The vertical arm 172 is spanned at its uppermost end by a horizontal cap 175. The anesthesiologist pulls the cap 175 towards the top of the plunger 110. The block 176 on the end of the vertical extension 170 causes the spring 169 to become compressed. The anesthesiologist then slides the cap 175 over the top end of the plunger 110. The locking bar 171 moves with the cap 175 and, as such, the locking bar 171 moves past the blocking pin 177 connected to the actuating member 30. Once the cap 175 is positioned atop the plunger 110, the locking bar 171 engages the blocking pin 177, which prevents depression of the plunger 110.

When the actuating member 30 is pulled inward, the blocking lever 177 is pulled outward via a rotational movement. This removes the blocking pin 177 from the path of the locking bar 171 and the spring 169 attempts to return to its original extended position. The elongation of the spring 169 pulls the vertical extensions 173 via the blocks 176, which in turn pull the vertical arms 172 and the cap 175. Thus, the ejection mechanism provides continuous pressure against the plunger 110. As shown in fig. 12A, blocking pin 177 has been removed and cap 175 is applying downward pressure to plunger 110. As with other configurations, interaction with the actuation member 30 opens the pressure relief valve 104 so that the contents of the syringe 102 can flow into the conduit 20.

Fig. 13B shows an alternative design of this configuration, in which the tip 115 of the syringe 102 is connected directly to the catheter 20 via a luer lock, luer fitting, or other similar connection means. The actuation member 30 is mounted on the housing 160. The housing 160 has a top base 179 with a central opening 181. Central opening 181 allows passage of syringe barrel 105 but does not allow passage of finger tabs 117. Like the previous design, the ejection mechanism 167 extends over the top of the plunger 110 and provides downward pressure on the plunger 110. This design does not have a pressure relief valve. Alternatively, the fluid is retained within the syringe because the relatively small amount of pressure pushing the liquid down when the blocking pin is in place is overcome by the atmospheric pressure pushing up in the conduit 20. In addition, the surface tension of the fluid prevents droplets from forming and dripping through the conduit 20. One advantage of the design depicted in fig. 12B is that the dispensing mechanism is reusable because the contents of the vial are not in contact with the dispenser. The catheter 20 and syringe 102 will be replaced for future use.

Fig. 13C-13D show another alternative design of the ejection mechanism 167. The syringe 102 is placed in the cradle 308. The syringe is held securely in place with a plurality of fastening members 310. These lateral fastening members 310a have gripping surfaces made of rubber or similar material so that they frictionally engage the syringe 102 when the syringe is snapped into the cradle 308. The longitudinal fastening member 310b locks and prevents the syringe from sliding downward when the LTA device 10 is held upright and from being pulled out of the cradle 308 when the plunger 110 is withdrawn. As with the previous embodiment, the hanger 308 has a (features) vertical extension 170 with a spring 169 extending between the hanger 308 and a block 176 on the depending end of the vertical extension 170. A cap 175 is on top of the vertical extension 170. In this embodiment, the cap optionally has a handle 312 to assist in pulling the ejection mechanism 167 on the plunger 110. The cap 175 does not directly exert pressure on the plunger 175; alternatively, the protrusion 314 engages the top of the plunger 110 to provide a downward force.

Another feature of the embodiment shown in fig. 13C-13D is a pin and slot locking mechanism. Slotted rod 316 extends downwardly from cap 175 and through hanger 308. Actuating member 30 has a pin (not shown) that engages a slot through a cavity 318 in hanger 308. When the pin engages a slot on the slotted rod 316, the slotted rod 316 is prevented from moving. Because the slotted rod 316 is in mechanical communication with the cap 175, the ejection mechanism 167 is also prevented from moving. Thus, when the actuation member 30 is actuated, the pin is removed from the slotted rod 316 and the ejector mechanism 167 and plunger 110 begin to lower. When the user releases pressure on the actuation member 30, the pin will slide into another slot on the slotted rod 316, wherein the movement of the rod and thus the pressure on the plunger 110 is stopped.

In yet another configuration, the pressure is applied to the plunger via a separate electromechanical device. For example, as shown in fig. 14, the plunger 110 is driven by a linear motor 183, such as a linear magnetic motor or a piezoelectric motor. Additionally, the motor may be a rotary motor linked to a gear mechanism (e.g., a worm gear) to provide linear motion. Advantageously, these motors may be controlled using a variety of actuation members 30. The button, foot pedal, switch, and pressure plate are all in the form of an actuating member that may be used in electrical or wireless communication with the pressure relief valve 104 or any other potential valve type. In one configuration depicted in fig. 14, actuation occurs via wireless infrared communication, with the communicator positioned on a direct laryngoscope blade handle 185.

The above discussion of the dispensing mechanism, actuating components, and valve control is not intended to be limiting. Many dispensing mechanisms, actuating components and valve controls may be combined with other mentioned or non-mentioned dispensing mechanisms, actuating components and valve controls not presented herein.

Details of the ducts and nozzles

Conduit 20 provides fluid communication between dispenser portion 15 and nozzle 25 of device 10. During intubation, the catheter 20 is substantially enclosed in the ETT 31. The ETT 31 is typically made of flexible polymer tubing such as PVC, high or low density polyethylene and polypropylene. The ETT 31 is first slid over the conduit 20 and then the combination of the conduit 20 and ETT 31 is formed into the desired shape. The dispenser portion 15 engages a first end of the ETT 31 via a reversible frictional engagement, such as the standard straight sliding joint connectors found on most endotracheal tube connectors.

The LTA device 10 should be easily removed after intubation is complete so that general anesthesia and patient ventilation may begin to be performed. During typical intubation, the static friction used to hold the LTA device in the ETT makes it difficult to remove the stylet from the endotracheal tube many times. Because the anesthesiologist's hands are occupied by the ETT and laryngoscope (laryngoscope), many times an assistant is required to disengage the stylet from the ETT while the anesthesiologist holds the ETT in place in the trachea or slides the ETT further into the trachea. Some anesthesiologists have adapted to move their hands upstream of the ETT and then remove the stylet with their thumb. However, this technique requires a high level of skill and dexterity, and the ETT may easily become dislodged.

As shown in fig. 15A, the present invention has a tab 187 protruding from the actuation member 30. The tabs 187 allow the user to push his thumb or finger against the tabs 187 (where leverage is obtained) and forcibly displace the LTA device 10 out of the ETT at least partially. In some designs, the surface of tab 187 is grooved to assist in frictional engagement between the tab and the finger. The tabs 187 may also be concave to better receive the distal or middle phalanx of a finger. Furthermore, in these embodiments, the actuation member 30 may be prevented from rotating about the fulcrum 90 in a manner opposite the actuation direction. This helps to ensure that the pressure applied by the finger causes an upward displacement and ensures that the actuation member does not rotate in the reverse direction. Alternatively, as shown in fig. 15B, the tab 187 may directly engage and apply a force to the proximal end 31p of the ETT 31, causing forward displacement of the ETT 31 on the catheter 20 when the lever is pressed. The tab 187 is linked to the actuation member 30 such that depression of the trigger causes the tab 187 to engage the ETT 31, which displaces the ETT 31.

A significant feature of the LTA device 10 is the ability to function as a combined stylet and introducer during intubation. For this purpose, the catheter 20 is made of a malleable material so that the catheter 20 can be reversibly deformed into various shapes. The inventors have found that 13 gauge 304 stainless steel hypodermic tubing is a suitable material. This material had an outer diameter of 0.0950", an inner diameter of 0.071" and a wall thickness of 0.012 ". Various other hollow and deformable non-toxic biocompatible materials would also be feasible. In addition, the stylet may be pre-formed or molded into the desired shape and used as the catheter 20 of the LTA device 10.

Two commonly used auxiliary cannulae are pointed and straight to the cuff. The pointed shape provides a semi-rigid guide in the natural shape of the ETT. The straight shape up to the cuff, as its name implies, provides the following stylet: the stylet keeps the length of the ETT straight until the capsule envelope is reached. The stylet is then bent at an angle between about 35 ° and 80 °, which causes the ETT to look like the shape of a hockey stick. Greater or higher angles may be employed depending on user preference and the environment of the cannula. In some circumstances, a straight shape up to the cuff may provide better visualization of the glottis.

The proximal end 31p of the ETT 31 slides over the nozzle 25 and conduit 20 until it reaches the dispensing portion 15. The dispensing portion 15 and proximal end 31p of the ETT 31 are frictionally engaged and the combined device is ready for intubation. The combination of the LTA device 10 and ETT 31 then forms a pointed, straight to the cuff, or other desired shape. The anesthesiologist performs a direct laryngoscope examination of the patient and introduces the LTA device 10 and ETT 31 through the patient's mouth. As needed, the anesthesiologist distributes local anesthetic along the vocal cords to parts of the airways, such as the tracheobronchial tree, and the hypopharynx, including the epiglottis. Any of the dispensing components previously discussed may deliver anesthetic from the cartridge to the catheter 20. The conduit 20 provides a fluid path to a nozzle 25 which discharges the anesthetic in the form of a spray.

The nozzle 25 of the LTA device 10 is designed to extend beyond the distal end 31d of the ETT 31 and serve as an outlet for local anesthetic. The angled configuration of the nozzles is between about 15 degrees and 90 degrees relative to the longitudinal axis of the conduit 20. This angle helps to facilitate intubation, particularly because the nozzle is placed in close spatial relationship to the cuff 32 and distal to the cuff 32. This configuration of angling and blunting the nozzle defines the tip of the combined anesthetic nozzle and ETT introducer. In one embodiment shown in fig. 15A, the nozzle 25 is a tube 189 having a plurality of perforations 191 in the sides and ends. In the preferred embodiment shown in fig. 15B, the nozzle 25 is designed to produce a radial spray. The nozzle 25 has a shaft portion 193 with a slit 195 on a distal surface 197. The slit 195 is narrow relative to the shaft portion 193 to allow the anesthetic to be ejected at high velocity according to the bernoulli principle and to dispense the liquid as a spray. In addition to slits, other openings are suitable, including scalloped, tapered, and circular openings. The cone 199 deflects the mist radially and the plurality of baffles 201 further distributes the mist.

Having the nozzle 25 extend beyond the distal end 31d of the ETT 31 provides several unique advantages. First, the anesthetic can be delivered during intubation (prior to delivery of the anesthetic, the prior art device must be placed first). Second, because the nozzle 25 is positioned distally relative to the capsule envelope 32, the risk of anesthetic agent accumulating in situ over the envelope is eliminated. Some prior art devices have dispensing points along the length of the ETT. While this allows for continued administration of local anesthetic while the ETT is in place, it also means that anesthetic is delivered over the capsular cuff. Typically the anesthetic will flow down the trachea and pool at the cuff. Such a concentrated anesthetic dose is known to cause damage to sensitive tissues of the trachea. Again, the use of a nozzle helps to propel and spread the anesthetic spray to evenly cover a wide area. Prior art devices typically use a series of perforations to deliver the anesthetic. These may or may not produce a spray, but the reach of the spray is much less than in the present invention. Thus, the present invention enables the use of shorter nozzles, which avoids the difficulty of handling larger features through the structure of the airway.

In both embodiments, the nozzle 25 is preferably made of a flexible, non-rigid material in order to avoid perforation of the trachea. Preferably, the tip 203 of the nozzle 25 is blunt or non-angled to prevent trauma to other structures in the trachea and throat. In addition, the nozzle 25 may be at a slight angle relative to the rest of the catheter 20 to further reduce the risk of tracheal perforation. This angled tip (similar to a korde tip) may also provide the anesthesiologist with a slight advantage in placement of the LTA device 10 through the vocal cords in cases where intubation is difficult (as in "anterior airways"). The nozzle 25 provides tactile feedback as the nozzle 25 passes over the tracheal ring. Because of the close proximity of the trachea and esophagus, an anesthesiologist may accidentally insert an ETT into the esophagus. However, the trachea contains tracheal rings, which are cartilaginous projections on the tracheal wall, while the esophagus is smooth. Thus, if the nozzle springs away from the tracheal ring during intubation, the anesthesiologist can confirm that the correct path was inserted.

The distributor 15 and the conduit 20 and the nozzle 25 may be designed to be functionally modular. This would allow the dispensing section 15 to be used with different conduits 20 and nozzles 25. For example, a smaller catheter 20 may be necessary for use with pediatric patients. The modular design would allow the same dispenser to be used by simply switching between conduits.

Additional embodiments of the nozzle are provided in fig. 17A-17B, 18, 19 and 20. Fig. 17A shows a general configuration common to alternative nozzle embodiments. The nozzle 25 has a first body portion 210. The first body portion has a first end 212 and a second end 214. As can be seen in the cross-sectional view of fig. 17B, the first body portion 210 has a channel 216 that extends between the first end 212 and the second end 214. Channel 216 has a tapered region 218 terminating in an aperture 220 in second end 214. The tapered region 214 helps to accelerate the flow rate of the liquid in the channel 216 so as to produce a liquid jet that exits (erurging) the orifice 220. The channel 216 is not limited to a geometric shape; in particular, circular, oval, rectangular or rectangular geometries without corners are acceptable. In addition, the tapered region 218 may taper in all directions or, for example, it may taper in only one direction, i.e., flatten the channel. Preferably, the shape of the orifice matches the cross-sectional dimension of the tapered region 218, but this is not necessarily so.

Returning to fig. 17A, the second body portion 222 is opposite and in linear registration with the aperture 220. The second body portion 222 is held opposite the aperture via at least one support arm 224. As depicted in fig. 17A, the second body portion 222 is retained using two support arms 224. The support arms 224 are preferably wedge-shaped, i.e., the width of the support arms 224 is wider near the outer portion and tapers toward the inner portion. However, the support arms 224 need not be wedge-shaped; alternatively, the support arms 224 may have a smaller thickness and a relatively uniform width.

The second body portion 222 includes two sections: a baffle 226 and a tip 228. The liquid jet exiting the orifice 220 contacts a baffle 226 which radially distributes the liquid in the form of a mist. The baffle 226 is spaced from the second end 214 by a distance of about 1mm to about 0.5 mm. The tip 228 is non-angled or blunted to avoid damage to the patient's airway. The baffle 226 may be of various shapes. As depicted in fig. 17A, the baffle 226 is frustoconical. Fig. 18 depicts a hemispherical baffle 226. Fig. 19 depicts a baffle having a truncated conical body 226a that transitions to a cylindrical protrusion 226 b. The tip of the frustoconical body 226a may also include additional contours. As shown in fig. 19, the tip has an M-shaped design 227 to help facilitate the dispensing of the liquid.

As shown in fig. 20, the tip 228 has an extended length. In this way, tip 228 is shaped like a cylinder surmounted by a hemisphere. This embodiment is of considerable benefit when the nozzle is also used as an introducer during intubation. The elongated tip 228 may be combined with any of the baffle embodiments described above.

Prior art nozzles typically have a plurality of holes (holes) for dispensing the pressurized liquid. However, the liquid entering these nozzles tends to drool rather than form a mist. The result is an uneven distribution of anesthetic in the patient's airway. Thus, to achieve better dispensing, the holes are made very small to increase the pressure on the liquid exiting the holes. In order to make very small holes in the nozzle, the material used must be very stiff, since the flexible or soft material will deform, actually sealing the holes. Although the use of a stiff material is not ideal because of the risk of damaging the patient's airway and the risk of breaking the nozzle in the patient's airway.

Accordingly, one significant advantage of the present invention is that the nozzle has a single orifice, and thus this orifice can be relatively large compared to the very small holes of prior art nozzles. Because the orifice is large, the nozzle can be made of soft materials, which greatly reduces the above-mentioned risks and risks. Suitable materials for constructing the nozzle include silicone and polyethylene, among others. Another advantage of the present invention is that it may have a unitary construction, meaning that the nozzle does not have to have split points where it may break in the airway of the patient. Yet another advantage of the nozzle is that it does not have any sharp corners or overhangs. In this way, nothing gets stuck in the patient's airway.

The nozzle engages the distal end of the catheter via a tight frictional engagement. Adhesives may also be used to increase the safety of the fit.

Additional benefits of this nozzle design include its ability to pass through or have an ETT pass over, including pediatric ETTs; the single orifice configuration allows for more efficient and higher velocity spraying; and it can be used for both video and standard direct laryngoscope detection.

Intravenous embodiment

Many of the dispensing mechanisms discussed above are also suitable for intravenous delivery of anesthetic or drugs. Fig. 21 depicts an intravenous embodiment of a dispenser.

The dispenser 250 is generally the same as the vial embodiment. The dispenser 250 includes a housing 255 containing a plunger 260 and a needle 265. The housing 235 is adapted to receive the vial 270. The plug 272 is sunk into the vial 270. The main difference is the lack of a pressure relief valve. Instead of a pressure relief valve communicating with the actuating member, the fluid passage formed by the needle terminates in a luer fitting 274 that engages a variable flow regulator 276 or a stopcock 278 that communicates with a passive flow regulator 280. Variable flow regulators are commercially available, such as those available from Quosina corporation (Ebiwood, N.Y.). The flow regulator 276 or 280 is then placed in direct communication with the intravenous tubing via a luer lock or another similar adapter.

In operation, the dispenser 250 provides a sustained and controlled release of the anesthetic or drug. The piston 260 in the dispenser 250 creates a continuous pressure on the fluid within the vial, forcing the fluid into the passage defined by the needle 265. The flow exiting the dispenser 250 is controlled by a variable flow regulator 276 or a passive flow regulator 280 that also compensates for the reduced pressure as the dispenser dispenses the medicament.

The dispenser of the current invention may be used in a variety of contexts where a sustained and controlled release of fluid is required. For example, often drugs need to be delivered slowly to a patient, but such delivery need not be so precise as to require a large intravenous pump. In addition, some drugs are only commercially available in the form of vials or syringes. Previously, physicians or nurses had to slowly administer drugs to patients, which in some circumstances can take up to ten minutes, and this fact produces highly inaccurate doses. The present invention allows the user to provide a sustained release without requiring someone to administer the dose. Alternatively, the medical professional may perform other care-related tasks during the injection procedure, such as a computer-generated watch. Advantageously, embodiments of the device comprise only passive components, i.e. components that require no electrical or mechanical input other than the force required to load the cartridge and set the flow rate. The passive component design improves the reliability and predictability of the device.

One procedure that the device of the current invention can have a substantial impact is in local anesthetic nerve block surgery. During the nerve block procedure, the physician supplies a dose of local anesthetic at or near the nerve. To find the appropriate nerve and determine the dose, the physician performs an ultrasound examination of the region of the body where the nerve block is to be delivered. As depicted in fig. 18A, the physician is holding the ultrasound probe 285 in one hand and the needle 290 in the other hand. Previously, the needle was connected to the syringe intravenously, and the physician required an assistant to depress the plunger on the syringe to administer the dose. Now, using the invented device, the physician can simply press the button to deliver the dose at the right time and the right location.

As shown in fig. 18B, the needle 290 is connected to a handle 292 having a finger guard 294. The connection is a standard luer lock or luer fitting connection. The valve 296 blocks fluid flow at an upstream portion of the handle 292. The valve 296 is substantially similar to the pressure relief valve 104 in that it includes a movable mass 298, a through hole 300, a spring 302, and a protrusion 304. Here, the tab 304 serves as a button that the anesthesiologist can press to dispense the anesthetic. Further upstream, the valve is connected to the intravenous catheter 306 via another luer lock or luer connection. The intravenous catheter 306 carries fluid from the dispenser 250. Optionally, a passive flow regulator 280 is placed between the dispenser 250 and the intravenous catheter 306. This arrangement provides a continuous flow of pressurized anesthetic that can be easily supplied by the physician to the needle 290 without the assistance of an assistant.

It is to be understood that the above description is intended to be illustrative, and not restrictive. For example, the above-described embodiments (and/or aspects thereof) may be used in combination with each other. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from its scope. While the dimensions and types of materials described herein are intended to define the parameters of the invention, they are by no means limiting and are exemplary embodiments. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. In the appended claims, the terms "including" and "in which" are used as the plain-english equivalents of the terms "comprising" and "in whiich". Furthermore, in the following claims, the terms "first," "second," and "third" are used merely as labels and are not intended to impose numerical requirements on their objects. Additionally, the limitations of the following claims are not written in device-plus-function (means-plus-function) format and are not intended to be interpreted based on 35u.s.c. § 112(f), unless and only if such claim limitations explicitly use the phrase "means for … …" followed by a functional statement and no other structure.

The present methods may involve various combinations of any or all of the steps or conditions discussed above as desired. Accordingly, one skilled in the art will readily recognize that in some of the disclosed methods, certain steps may be eliminated or additional steps may be performed without affecting the viability of the methods.

As will be understood by those skilled in the art, for any and all purposes, particularly in the sense of providing a written description, all ranges disclosed herein also encompass any and all possible subranges and combinations of subranges thereof. Any listed ranges may be readily recognized as being fully specified and enabling the same ranges to be broken down into at least equal halves, thirds, quarters, fifths, tenths, and so forth. As a non-limiting example, each range discussed herein may be readily broken down into a lower third, a middle third, and an upper third, among others. As will also be understood by those of skill in the art, all languages, such as "up to," "at least," "greater than," "less than," "more than," and the like, include the recited number and refer to ranges that may be broken down into subranges as discussed above. In the same way, all ratios disclosed herein also include all sub-ratios falling within the broader ratio range.

Those skilled in the art will also readily recognize that when members are grouped together in the usual manner, such as a markush group, the present invention encompasses not only the entire group as a whole, but each member of the group individually as well as all possible subgroups of the main group. Accordingly, for all purposes, the present invention encompasses not only the main group, but also the main group lacking one or more group members. The present invention also contemplates explicitly excluding one or more of any of these group members from the claimed invention.

Claims (20)

1. A liquid dispensing device, the device comprising:

a conduit having an upstream end and a downstream end;

a housing having a first end and a second end, wherein the first end is open and the second end forms a flat base, and wherein the housing is adapted to receive a vial for holding a liquid and having a stopper;

a piston, wherein the piston applies pressure to the plug;

a needle inserted through the stopper and providing fluid communication between the interior of the vial and the upstream end of the conduit such that the needle defines a passage through the piston; and

a valve for releasing liquid into the upstream end of the conduit, wherein the valve is biased closed until actuated by a user, and wherein the valve is located downstream of the housing.

2. A liquid dispensing device as claimed in claim 1, wherein the conduit is a narrow tube.

3. A liquid dispensing device as claimed in claim 2, wherein the narrow tube is reversibly deformable into a desired shape.

4. A liquid dispensing device as claimed in claim 2, wherein the conduit terminates in a nozzle.

5. A liquid dispensing device as claimed in claim 1, wherein the conduit is a needle.

6. A liquid dispensing device as claimed in claim 1, wherein the piston extends from the planar base.

7. A liquid dispensing device as claimed in claim 1, wherein the piston is slidably received within the housing forming a compression chamber between the seat of the piston and the flat base, and wherein the flat base has a through passage in fluid communication with the valve.

8. The liquid dispensing device of claim 1, wherein the piston is a spring contained in the vial downstream of the stopper.

9. A liquid dispensing device as claimed in claim 1, wherein the piston is a stationary ram extending from the housing, wherein a one-way valve arrangement is arranged upstream of the valve and within the ram, and wherein a second one-way valve is arranged between the valve and the conduit.

10. A liquid dispensing device as claimed in claim 1, wherein the housing and the valve are separated by a section of flexible tubing, and wherein the conduit is in a needle.

11. A liquid dispensing device as claimed in claim 1, wherein the valve is a variable flow regulator.

12. A nozzle adapted for receipt by a patient, the nozzle comprising:

a first body portion having a first end and a second end, wherein a central aperture extends between the first and second ends, and wherein the central aperture terminates in an opening at the second end;

a second body portion having a first end and a second end that is free of corners; and

at least one support arm joining the second body portion to the first body portion and holding the second body portion at a set distance from the first body portion.

13. The nozzle of claim 12, wherein the first end of the second body portion defines a frustoconical shape.

14. The nozzle of claim 12, wherein the first end of the second body portion defines a tapered shape.

15. The nozzle of claim 14, wherein the tapered shape of the first end defines a non-angular tip.

16. The nozzle of claim 12, wherein the first end of the second body portion defines a non-angular shape.

17. The nozzle of claim 16, wherein the non-angular first end and the non-angular second end of the second body portion define a substantially spherical shape.

18. The nozzle of claim 12, wherein a cylinder is disposed between the first end and the non-angled second end of the second body portion such that the second body portion is lengthened.

19. The nozzle of claim 12, wherein the first end of the second body portion has at least one wedge-shaped baffle.

20. The nozzle of claim 12, wherein the first end of the second body portion is ribbed.