Patent Application
20210085902
The present application is related to a breathing apparatus, for providing rescue breathing to a patient who is either limited in their ability to breathe or is unable to breathe.
Current rescue breathing technology is primarily related to direct mouth-to-mouth CPR and breathing bags. Breathing bags, such as those by AMBU® are compressible bags that compress the air in the bag and allow that air to be directed towards the lungs of a patient in need of breathing support. The breathing bags are single use devices and have been in use for decades.
To use an AMBU® bag, the bag is connected to an endotracheal tube, which is inserted into the patient's mouth and into the esophagus. Once the endotracheal tube is inserted, the bag is compressed to provide air. While these devices have had a long history of success, they suffer from several issues, specifically related to their single direction of functionality, size, and cost. For example, one issue is that the bag needs to be attached to the endotracheal tube with a particular orientation. Accordingly, once the bag is attached to the tube, the components must be held in that orientation to prevent the tube from being displaced from the patient. Furthermore, the bag is placed nearly on the patient's face, and movement of the patient or other obstacles near the patient's mouth can be problematic for sufficient compression or even just for use of the device at all. Accordingly, as the bag needs to have sufficient space to be compressed, in certain instances, it is nearly impossible to properly use such a bag or to keep the endotracheal tube properly inserted into the patient for rescue breathing.
Bags can also be attached directly to a face mask, instead of a tube. Again, this poses the same issue with regard to proximity and obstacles in front of the patient's face, to prevent appropriate rescue breathing.
The following presents a simplified summary of the invention in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the invention. It is not intended to identify key/critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some concepts of the invention in a simplified form as a prelude to the more detailed description that is presented later.
In a particular embodiment, a rescue breathing apparatus comprises a flexible tubing having a patient side end and a rescue side end (opposing ends of the tube), the patient side end connected to an adapter, which connects to a one-way valve. The one-way valve has a first and second end, the first connected to the adapter the opposing end connected to a double swivel elbow. The rescue side end of the tube is connected to a mouthpiece to allow for air to be generated through the tube.
In a particular embodiment, the double swivel elbow is connected to an airway generating device, including but not limited to an endotracheal intubation, surgical cricothyrotomy, an airway adjunct, or a facemask. The rescue side end of the rescue breathing apparatus is connected to a mouthpiece, wherein a breath can be provided by rescue personnel. Alternatively, an air compression bag can replace the mouthpiece and be compressed by hand or mechanical force to provide air. Alternatively, an air compression machine can provide air through the tube.
A particular embodiment is directed towards a rescue tube comprising a tube having a first and second end, a one-way valve and a ported double swivel elbow; wherein the one-way valve and ported double swivel elbow are connected to one another, and the one-way valve is attached to the tube. The rescue tube further comprising a first adapter disposed of between the first end of said tube and the one-way valve. The rescue tube further comprising a second adapter disposed of on the second end of said tube. The rescue tube wherein said ported double swivel elbow is a Y-shaped apparatus comprising a first and second opening, and a port. In certain embodiments, said ported double swivel has said first opening attached to a one-way valve and said second open attached to an airway adjunct. In certain embodiments, the double swivel elbow comprises an accordion portion.
A method of providing rescue breathing to a patient comprising intubating said patient with an airway adjunct; attaching to said airway adjunct a rescue tube comprising a tube having a first and second end, a one-way valve and a ported double swivel elbow; wherein the one-way valve and ported double swivel elbow are connected to one another, and the one-way valve is attached to the tube; breathing into said second end of said tube. The method wherein said second end of said tube comprises a mouthpiece. The method wherein further comprising attaching to said second end of said tube a bag device capable of being compressed to provide air to said patient, and compressing said bag to perform the step of breathing into said second end of said tube.
A preferred embodiment is directed towards a rescue tube comprising a tube having a proximal and distal end, and attached to the proximal end is a one-way valve, said one-way valve having a flow end and a check end, and allowing flow of air from the distal end to the proximal end, and attached to the check end of the one-way valve is a ported double swivel elbow having a long arm and a short arm, and wherein the long arm and short arms are attached at an angle with a passage allowing passage of gas through the short and long ends to the opening at each end, wherein the opening on the short arm is attached to the check end of the one-way valve, wherein the opening on the long arm is suitable for connection to a breathing device; and wherein connected to the distal end of said tube is a mouthpiece.
In preferred embodiments, the rescue tube further comprising a first adapter disposed of between the proximal end of said tube and the flow end of the one-way valve.
In preferred embodiments, the rescue tube further comprising a second adapter disposed of on the distal end between the distal end of the tube and the mouthpiece.
In preferred embodiments, the rescue tube wherein said ported double swivel elbow is a Y-shaped apparatus made of the short and long arms, and a port in the short arm, and comprising an accordion structure on the long arm, said accordion structure capable of extending in length and flexing at least 90 degrees.
In preferred embodiments, the rescue tube wherein said breathing device is an airway adjunct. In preferred embodiments, the rescue tube wherein said airway adjunct is an endotracheal tube.
In a preferred embodiment, a method of providing rescue breathing to a patient comprising intubating said patient with an airway adjunct; attaching to said airway adjunct a rescue tube comprising a tube having a proximal and distal end, and attached to the proximal end is a one-way valve, said one-way valve having a flow end and a check end, and allowing flow of air from the distal end to the proximal end, and attached to the check end of the one-way valve is a ported double swivel elbow having a long arm and a short arm, and wherein the long arm and short arms are attached at an angle with a passage allowing passage of gas through the short and long ends to the opening at each end, wherein the opening on the short arm is attached to the check end of the one-way valve, wherein the opening on the long arm is connected to the airway adjunct; and wherein connected to the distal end of said tube is an air imparting component capable of forcing air through the tube and into the airway adjunct; forcing air through the tube and into the airway adjunct to generating a breath to the patient; allowing the patient to exhale the forced air.
The method wherein the air imparting component is a mouthpiece.
The method wherein a second person breathes into the mouthpiece to force air through the tube.
The method wherein the air imparting component is a breathing bag.
The method wherein the breathing bag is compressed to force air through the tube.
A further preferred embodiment defining a rescue tube comprising a length of flexible tubing, defining a passage between a proximal and distal end of said tube, and attached to the proximal end of said tube is a one-way valve, said one-way valve having a flow end and a check end, with said one-way valve oriented with the proximal end of said tube engaged to the flow end of said one-way valve thereby allowing flow of air from the distal end to the proximal end of said tube, and attached to the check end of the one-way valve is a ported double swivel elbow having a long arm and a short arm, and wherein the long arm and short arms are attached at an angle with a passage allowing passage of gas through the short and long ends to the opening at each end, wherein the opening on the short arm is attached to the check end of the one-way valve, wherein the opening on the long arm is suitable for connection to a breathing device; and wherein connected to the distal end of said tube is air imparting structure.
In preferred embodiments, the rescue tube wherein said short arm comprises a self-sealing port.
In preferred embodiments, the rescue tube wherein the ported double swivel elbow comprises an accordion structure on the long arm, said accordion structure capable of bending. In preferred embodiments, the rescue tube wherein said accordion structure is capable of bending at least 90 degrees. In preferred embodiments, the rescue tube wherein said accordion structure is capable of extending in length.
In preferred embodiments, the rescue tube said tube having an inner diameter between 10 and 25 mm.
In preferred embodiments, the rescue tube further comprising an adaptor defined to connect between the proximal end of said tube and said one-way valve.
In preferred embodiments, the rescue tube further comprising an adaptor defined to connect to the distal end of said tube, and wherein an air imparting structure is connected to said adaptor. In preferred embodiments, the rescue tube wherein said air imparting structure is selected from: a mouthpiece; said mouthpiece comprising an insertion end connected to said adaptor, and a breath giving end; said breath giving end comprising a flange, a breathing bag, or a mechanical air flow generating machine.
In a medical situation whether in military operation or emergency events, there are situations where rescue breathing must be provided to an unconscious patient who requires an airway to maintain oxygen to the lungs. In most instances today, a breathing bag, such as those by AMBU®, is frequently utilized, which can be held on the patient and compressed to force air into the lungs. The bag is directly attached to an endotracheal tube, and once the tube is inserted, the bag is compressed. After the patient's lungs are filled with air through the compression of the bag, the lungs, due to the weight of the cavity, decompress the forced air, and exhale the air, thus completing a single “breath.” After compression, the bag reinflates, and the process can be repeated. Subsequently, another compression may proceed, to again force a breath into the patient.
However, performing this procedure requires that at least one hand from rescue personnel is placed onto the bag to perform these compressions. In some instances, two hands would be required to properly compress the bag and to give sufficient breath to a patient. The loss of a hand, or hands is problematic in both military instances as well as in nonmilitary emergency situations.
Indeed, as described herein is a rescue tube comprising components and features that allow for a user to maintain the use of their hands for other tasks, while providing rescue breathing to a patient. For example, breathing may be maintained, while the rescuer treats other wounds. In military situations, the rescuer may need hands to maintain a weapon or to remove both the rescuer and the injured from the battlefield as urgently as possible, and thus having free hands to maneuver or manipulate additional devices is necessary. For example, the rescuer can use both hands to lift and carry the injured away from the battlefield.
The rescue tube functions as an extension between the provider and the patient. However, the patient must first have a breathing tube inserted. Examples of breathing tubes include endotracheal tubes, as well as mouth insertion devices, for example, comprising cuffs to enter the trachea. Examples including the King Airway® and Combitube®, though other brands and examples exist. In general, these devices are airway adjuncts, devices that can be placed into reach the trachea to provide oxygen. For mouth placed devices, these often include a balloon or cuff that blocks the esophagus to allow air to enter the trachea, to fill the lung.
The embodiments of the invention described herein, provide a novel device, a rescue tube, to connect to one or more breathing devices. For example, as depicted in
Preferably, the second component to be received into the proximal (22) end of the tube (2) is an adaptor (10). For example, in the proximal (22) end of
The first end (11) and second end (13) of the adaptor are defined to be received into the proximal end (22) of the tube, on one end, and then to have a suitable outer or inner diameter to mate with the flow side opening (16) of the one-way valve (12). Accordingly, the adaptor (10) functions as one of ordinary skill in the art would expect it to function, it allows for connection of the proximal end of the tube (22) to the flow side opening (16) of the one-way valve. Those of skill in the art will recognize that the adaptor (10) is necessary only so far as the proximal end of the tube (22) requires such adaptor (10) to mate with the flow side opening (16) of the one-way valve. An appropriate tube diameter and corresponding diameter (or attachment means, for example those used by Luer-Lock® or other known attachment means), would allow for exclusion of the adaptor (10).
The one-way valve (12) functions to allow air to only flow through from the flow side opening (16) through the one-way valve internal valve (19) and through to the one-way valve check side. As those of ordinary skill in the art recognize, the one-way valve allows air flow only from the flow side (16) through to the check side (17). If air is pressed back from the check side (17), it will not pass through the internal valve (19), but will instead be released through the internal valve (19) (as a relief valve) to allow the air to exit the valve, but not proceed into the tube (2). Accordingly, this valve thus prevents passage of gasses back through this valve, and instead allows release of the exhaled gas.
The check side (17) then mates with a double swivel elbow (4). Finally, on the opposing end of the tube (2), (distal end of the tube [21]) a mouthpiece (15) is attached.
Into the second end (13) of the adaptor (10) is the one-way valve (12). Into the check side (17) of the one-way valve is inserted the short arm (50) end (5) of the double swivel elbow (4). Air passes through the check valve from the flow side (16) through to the check side (17) and now into the double swivel elbow (4). The long arm (51) of the double swivel elbow (4) possesses a junction (9) to allow for complete rotation of the double swivel elbow (4). Further the elbow (4) contains a self-sealing port (8). The long arm (51) of the double swivel elbow (4) further optionally possesses an accordion structure (7) to allow for further rotation and movement of the elbow (4), and ending on the long arm with a long arm opening (6).
However, the device may also be appropriately manufactured with components preattached, and this may include an adhesive suitable to attach such components. Where the rescue breathing device (1) is premanufactured, such features, like the adaptor (10) may be excluded, as the precise fit of the one-way valve (12) may be manufactured to fit into a proximal end (22) of the tube.
The long arm (51) of the double swivel elbow (4) possesses a junction (9) to allow for complete rotation of the double swivel elbow (4). In certain embodiments, the junction (9) allows for free rotation of the short arm (50) as compared to the long arm (51). In other embodiments, the components are fixed. The long arm (51) of the double swivel elbow (4) further optionally possesses an accordion (7) to allow for further rotation and movement of the double swivel elbow (4). For example, the accordion structure (7) can allow for flexible rotation, angled orientation of the components, and provides for a component that allows for a high range of motion and flexibility to safely insert and intubate a patient, while allowing for range of motion. For example, the extension feature (52) along the longitudinal axis of the long arm (51) allows for extension of the double swivel elbow (4) away from the face of the patient. Alternatively, the rotation or angling of the accordion structure (7) can angle according to (53). The angle should be able to extend at least 90 degrees, and preferably up to 180 degrees, where such angle can be generated along any orientation of the accordion structure (7). The ability to angle imparts additional flexibility to the use of the tube, because it allows for secure operation of the rescue breathing tube (1) while reducing the risk of extubation of the patient. At the end of the long arm (51) is the long arm end (6), for mating to a breathing device, such as a mask, endotracheal tube, or other device for positioning in the airway of a patient.
On one portion of the short arm (50) is gas line attachment feature (30). This allows direct connection of a typical oxygen line to the double swivel elbow (4). Typically, this can be used once a patient is to a safe setting and oxygen is available to assist in treating the patient. Other gasses can be administered through this line, as known to those of skill in the art.
In certain embodiments, the diameter of the tube (2) is such that no adapter (10) is required. Indeed, the adapter may include several different diameter adapters (10), wherein one end is of constant diameter, able to insert into the tube, while the other end has an outer diameter and an inner diameter, each of which can connect to a secondary device. Several adapters (10) can be included with a kit, each having different outer and inner diameters of the opposing end, to allow for a variety of secondary devices to be inserted therein. Certain secondary devices will fit directly into the tube (1) and thus the adapters (10) are optional for these features. The adapters (10) may further include locking or latching mechanisms, to selectively attach and detach secondary devices. For example, a breathing bag may selectively snap into place and remain securely connected, but may be optionally removed, if the breathing bag (40) is no longer needed, but connection to a different breathing apparatus would be advantageous.
Adapters are particular useful, however, to allow the tube to be a multipurpose material. Accordingly, the adapters allow for a plurality of components to be interchanged, as necessary, for the particular application of the breathing tube.
As depicted in
Furthermore, this extra space can also be used in certain rescue situations. For example, in the situation where an injured patient is in a space constrained position, due to a building collapse, due to a car accident, a military situation, or the like, the rescue tube can be attached to a breathing tube, and inserted into in small space for rescue breathing, wherein the bag may not easily fit in that space, or cannot be angled properly to allow for attachment. Accordingly, to provide rescue breathing, a rescuer can breathe directly into the opposed end of the flexible tubing (2). Alternatively, the rescuer can breathe directly into a mouthpiece (15), which can be attached to the tube, to allow for hands free breathing to the patient. Similarly, a bag (40) can be attached at the distal end (21) of the rescue tube and allow for compression of the bag to provide the air to the patient. In each case, the rescue tube provides for both stability of the breathing tube, as well as a flexible attachment to the breathing tube to provide mouth or bag generated air to the patient.
A further benefit of the rescue tube, whether use with a mouthpiece or with an attached bag (40), is that because of the flexibility of both the accordion structure (7) and of the flexibility of the tube (2), the tube (2) itself can freely move, while maintaining the endotracheal tube (23) in a stable spot within the patient. This is in direct contrast to the normal occurrence for a bag, which can easily move the endotracheal tube (23). Of course, this is a problem as a patient may be extubated in error, forcing rescuers to stop and reinsert the breathing tube to the patient. Furthermore, the bag may not easily connect to the breathing tube, thus forcing the rescuers to manipulate the patient or have a compromised bag (i.e. mostly compressed, or poorly attached), thus resulting in shallow or weak breaths to the patient.
Therefore, the rescue tube (1) provides for several benefits that are not seen in the prior art. First the tube provides for a flexible and accordion like structure to allow for total flexibility and movement of the tube, even when connected to the breathing tube on the patient. The distal end (21) of the rescue tube can then be open, for direct breaths from a rescuer, or can be attached to a mechanical lung, or attached to a bag, for providing oxygen rich air to the patient, and forcing air into the lungs. This provides for hands free operation of the rescue breathing tube (1). Second, because of the small structure, the rescue breathing tube (1) can fit into small spaces or locations and can allow for easier attachment to an endotracheal tube (23) and therefore attached to the patient regardless of the position of the patient. Finally, the flexible nature of the device prevents unintentional removal of the breathing tube.
Another way that the rescue tube can be utilized in a hands-free manner is to attach the rescue tube to an airway adjunct and connect the opposing end to a breathing bag. Because of the flexibility and length of the rescue tube, the bag can be placed under and arm, between the body, and then compressed to provide air to the patient. The bag could also be placed between an arm or body and another accessory.
The rescue tube can therefore be utilized in a method to provide oxygen to a patient comprising, inserting an airway adjunct to said patient, attaching to said airway adjunct a rescue tube, providing air into said rescue tube to provide air to said patient.
The invention as described herein can be modified based on the knowledge of a person of ordinary skill in the art with components that form the same or similar function. Those of skill in the art will recognize such possible variations and that these variations do not take away from the embodiments of the invention as described herein.
A method of providing a rescue breath to a patient comprising: attaching a rescue tube as described herein, to an endotracheal tube inserted into said patient; breathing into a distal end (21) of the rescue tube, wherein said breathing forces air from a mouthpiece (15) through a flexible tube (2), through a one-way (12), into a double swivel elbow (4), and finally into the endotracheal tube (23).
Those of skill in the art will recognize that the components are made of medical grade materials, each of which are capable of being sterilized for use. In preferred embodiments, the materials are fitted together, either with and adhesive or friction fit, and sterilized. The sterilized device can be packaged, and then sterile components can be utilized as needed. Accordingly, these devices, after use, can then be recycled or destroyed, or alternatively resterilized for future use.
Components are also sold as a kit, allowing for the components to be assembled based on the particular needs of a user.
In preferred embodiments, the device provides for rescue breathing use, while allowing for the rescuer to maintain free hands. A method of providing rescue breathing, therefore comprises inserting an air adjunct to the patient; attaching the rescue breathing device, and imparting air through the rescue breathing device to the patient, forcing air to the patient and letting the patient exhale before providing a further and successive breaths to said patient. The air can be provided via a mouthpiece, and rescue breaths provided by breathing into the mouthpiece. Alternatively, a breathing bag, which compresses air and forces it out of one end of the bag, can also provide air. Similarly, a machine or mechanical device can provide air under sufficient pressure.
This application is a continuation of U.S. patent application Ser. No. 15/983,963 filed on May 18, 2018, which claims the benefit of U.S. Provisional Patent Application No. 62/508,765 filed on May 19, 2017, with the United States Patent and Trademark Office, the contents of which are incorporated herein by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62508765 | May 2017 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15983963 | May 2018 | US |
| Child | 17247197 | US |
