Patent Application
20180289383
This invention is in the field of methods and devices for the treatment of a nose that is bleeding.
There are many human patients who suffer severely from a nose that bleeds with bleeding that is difficult to control. That is particularly true for the many patients who are required to take blood thinners to prevent a stroke that can be caused by atrial fibrillations of the heart. In U.S. Pat. No. 8,932,560, M. B. Dowling et al describe the use of chitosan that is a natural polysaccharide that is modified with hydrophobic moieties that has the capability for being able to cause blood to clot. What is needed for patients who suffer from severe bleeding of the nose is a novel means and method to apply chitosan or other blood clotting composition to the interior surface within that nostril of the nose that is bleeding.
The present invention is a means and method for controlling a severely bleeding nose, particularly for patients who are required to use a blood thinner to preclude the possibility of a stroke that can be a result of atrial fibrillation. The invention consists of a sponge-like material that is formed into the top section of a nasal insert that is slightly tapered so as to readily slide up into the bleeding nose and a bottom handle that is used for both inserting the bleed stopping device into the nose and removing it a few minutes later when the bleeding has been essentially stopped. The outside tapered surface of the bleed stopping device is coated and impregnated with the chitosan material that comes in contact with the inner surface of the nostril where the bleeding is occurring so as to cause the blood to clot to prevent further bleeding. The time for the bleeding to stop would typically be only a few minutes because of the ability of the chitosan to force a clotting of the blood at that point within the nostril where the bleeding is occurring.
Another novel feature of the present invention is a comparatively large diameter hole that extends for the entire length of the device which serves two important functions, namely: 1) to allow excess blood within the patient's nostril and nasal cavity to come out, and when that flow ceases, it allows the patient to breathe through that hole. Another important feature of this invention is that the device causes some mechanical pressure against the interior surface of the nose that is bleeding that also helps to stop that bleeding.
Thus one object of the present invention is to be able to insert a device coated with chitosan into the nostril of a patient's nose that is bleeding to form a blood clot in order to stop the bleeding.
Another object of this invention is to have the main body of the device be formed from a sponge-like material onto which and into which the chitosan is placed.
Still another object of this invention is to extend the sponge-like material downward from the portion that is inserted into the nose to form a handle that is held by the patient for both placing the device into the nostril that is bleeding and removing the device from the nose when the bleeding has been stopped.
Still another object of this invention is to have a hole that extends for the entire length of the device that allows the downward flow of any blood that has flowed above the top of the device and also allows the patient to breathe through the device until it is removed from the patient's nose.
Still another feature of this invention is to apply pressure against that interior portion of the nose that is bleeding to assist in stopping the bleeding.
These and other objects and advantages of this invention will become obvious to a person of ordinary skill in this art upon reading the detailed description of this invention including the associated drawings as presented herein.
The bottom portion of the device 10 is a handle 12 that is formed as one piece with the upper portion 11 from a sponge-like material such as that which is used for ear plugs. The handle 12 is used for both inserting the upper portion 11 into the nostril and removing the device 10 from the nostril after the bleeding has been stopped by the chitosan coating of the upper portion 11 having been exposed to the opening in the nostril where from which the bleeding originates.
Another novel feature of the device 10 is a hole 15 that extends in the axial direction 2 through the entire length of the upper portion 11 and the handle 12. If there is free blood that has flowed into the nasal cavity prior to the insertion of the device 10, then this free blood can come out of the nose through the hole 15. Once there is no blood flowing through the hole 15, it can be used for the patient to breathe through that hole until the device 10 is removed from that person's nostril.
Referring to
Blood clotting device 10 includes a through passage or hole 15 which extends throughout the length of the handle 12 and the upper portion 11 to provide an unrestricted flow path for passage of air and/or blood. As is seen in
Blood clotting device upper portion 11 may be formed of an open cell plastic composition, a closed cell plastic composition, or composed of some type of porous material consisting of a fibrous skeleton formed from an invertebrate or other synthetic material. In a preferred embodiment, the handle 12 and the upper portion 11 are formed of a sponge composition with the important consideration being that the upper portion 11 defines a flexible upper portion 11. Handle 12 may be in the preferred embodiment formed of a sponge material of the same composition material as the upper portion 11 to provide a flexible overall insert into the patient's nostril. In some embodiments handle 12 may be formed of a hardened material such as a rigid plastic which is adhered to upper portion 11 by glue or other type of bond.
As is clearly seen in
Blood clotting composition 14 may be formed or comprised of a chitosan or some other type of blood clotting composition, for example, comprising one or more of fibrinogen and thrombin mixtures, thrombin, Factor XIII, Factor X, Factor VII (of human, animal, or synthetic origin), oxidized regenerated cellulose, cellulose, collagen, keratin, gelatin, chitosan, chitin, alginate, dextran, cyanoacrylate, PEG, albumin, glutaraldehyde, kaolin, bentonite, laponite, montmorillinite, galodinium, and aluminum chloride. In use, blood clotting composition 14 may be coated on an exterior surface of upper portion 11 and/or impregnated therein when upper portion 11 is formed of an open cell plastic or sponge composition. In all cases, blood clotting composition 14 forms a coating on upper portion 11 to provide contact with a bleeding blood vessel.
Again as seen in
As seen in
Handle 12 additionally defines an annular cross-section with respect to axial direction 26 and provides for an outer diameter 25 which is less than the upper portion lower surface 30 diameter 22. The dimensional relationships of the upper portion 11 and the handle member 12 are depicted in
To accommodate various sizes of noses that could have bleeding controlled by the device 10, it is expected that the device would come in different lengths and diameters to accommodate different sizes of a human nostril. The range of sizes would be from as large as 1.0 cm in diameter for the major diameter of the upper portion 11 or as small as 0.3 cm diameter to accommodate a very small nostril. The length of the upper portion 11 would be approximately 2 cm with a maximum possible length of 4 cm and a minimum possible length of 1.0 cm. The taper angle 32 of the upper portion 11 could be as little as zero degrees or as much as 10 degrees with an optimum taper being approximately 3 degrees. Although the handle 12 could have a great variety of lengths and diameters, an optimum diameter would be about 2 mm smaller than the diameter 22 at the bottom of the upper portion 11 and the length could be anything from ½ cm to as long as 5 cm. The hole 15 that extends through the entire length of the device 10 could have a diameter as small as 1.0 mm to as large as 7 mm with an ideal diameter being approximately 4 mm. It is contemplated that the upper portion 11 exerts an outward force on the inner surface of the bleeding nostril of the patient to promote the stopping of the bleeding.
In one step of a method for the treatment of a bleeding nostril of a human nose, a device from a sponge-like material that has an upper portion that is formed integral with a handle, the outer surface of the upper portion being coated with a material that causes blood to clot is provided to the person with a bleeding nostril. In a further step, the device is inserted into the nostril of the human nose where the bleeding originates by holding the handle with the thumb and at least one other finger. In a furthers step, the device is removed by pulling downward on the handle after the bleeding has been stopped.
Various other modifications, adaptations and alternative designs are of course possible in light of the teachings as presented herein. Therefore it should be understood that, while still remaining within the scope and meaning of the appended claims, this invention could be practiced in a manner other than that which is specifically described herein.
