Surgery – Instruments – Internal pressure applicator
Reexamination Certificate
2000-09-01
2003-08-19
Worrell, Danny (Department: 3765)
Surgery
Instruments
Internal pressure applicator
C606S199000, C606S198000
Reexamination Certificate
active
06607546
ABSTRACT:
BACKGROUND
The field of invention relates to medical devices designed to stop serious nosebleeds. There are many products on the market to stop nosebleeds but none of them work much better than putting some type of gauze packing in the nose.
There is a need for a device that will treat the severe nosebleeds or major epistaxsis that is not controlled with gauze slipped into the nose. A device is needed for nosebleeds which are not easily stopped and to replace the one or two inflatable devices, presently available, which are mostly ineffective and tend to be painful.
Part of the difficulty with nosebleeds is that the nasal chamber is not a space with flat walls where pressure can be brought to bare. Instead, the nasal cavity has what can be thought of as serpentine deep grooves, called meatus recesses, in the side walls which are fairly narrow and make it difficult to produce pressure in these recessed areas. The present devices will not easily flow into these recesses to stop a nosebleed. A new device is required that will stop nosebleeds, which do not respond to simpler methods.
Another problem must be solved when designing a device to stop the more serious nosebleed. The nasal cavity is divided by a center wall, the nasal septum, which produces right and left nasal chamber airways. This center wall extends from the anterior opening of the nose posteriorly, but eventually ends so the posterior part of the nose is just one chamber. The new invention should be capable of entering both the right and left anterior nasal chamber airways or nasal cavities.
Therefore, the nasal cavity is made up of two divided chambers anteriorly and a common chamber posteriorly. Nosebleeds can occur either in the anterior or posterior cavities. It is relatively common, especially in older people, to be unable to see where the nosebleed is originating, especially when the treating physician is not an ear, nose and throat (ENT) doctor. When a doctor cannot find the source of bleeding, he/she will commonly call the nosebleed a “posterior nose bleed.” The nosebleed may be in the anterior ⅔'s of the nose or in one of the recesses or in the posterior ⅓ common chamber of the nose but a persistant nosebleed is still commonly called a “posterior epistaxsis”.
There is a need for a device that puts more uniform pressure into the nose. Presently used devices use a balloon to “blow up” in the nose but the balloon does not conform to the interior configuration of the nose. The balloon device attempts to fill the nasal interior with an expanding balloon by forcing more water into the balloon, but the balloon does not expand into the serpentine recesses of the nose. These recesses in the lateral wall of the nose are individually called a meatus. Meatus can be both singular and plural when describing more than one meatus. A meatus is created by an “overhang structure” on the side wall of the nose called a turbinate.
One of the early methods for treatment is for an “anterior” nose bleed, where gauze is placed into either the right or left side of the nose, whichever is bleeding, or at times both sides of the nose. A “posterior” pack can be placed into the nose in addition to the “anterior” gauze packing. A roll of gauze is inserted into the back of the nose and secured to a second roll of gauze at the opening of the nose with a string so the posterior gauze roll will not fall into the throat. This method is now seldom used since the Foley Catheter method was developed.
The Standard Urological Catheter (Foley Catheter) has a balloon that is expanded with water to put pressure in the back of nose, in the common space posterior to the center wall septum. This balloon also allows the physician to insert gauze into the front of the nose with less concern that the packing will fall into the throat and obstruct the airway. The catheter is clamped at the inlet of the nose to keep the balloon from moving backwards into the throat. The balloon of the Foley Catheter produces excessive pressure and pain when inflated in an attempt to fill the posterior cavity of the nose and still does not conform to or fill the entire space.
The XOMED™ Epistat™ (XOMED™ and Epistat™ are trademarks of Xomed Surgical Products Inc.) represents the latest technology used to attempt to stop the persistent nosebleed. The XOMED™ Epistat™ uses a catheter traversing through the right or left chamber of the nose. You could put one in each side of the nose. Two balloons are inflated with water. The larger balloon is meant to put pressure in the anterior nasal cavity that is divided into right and left side. The small balloon is meant to put pressure in the posterior chamber of the nose. This is the common chamber.
The XOMED™ Epistat™ has inflatable balloons where it is difficult to conform to the shapes of the nasal cavities, especially the anterior cavity. The anterior nasal cavity is the hardest to fill with a balloon. The expanding spherical or ovoid balloon will put minimal pressure in the crevices. Likewise, the posterior nasal cavity is not a sphere and the expanding bulb will not conform to the anatomical space.
In an attempt to control the bleeding, the physician will put more and more pressure in the balloons and this causes a significant amount of pain because of the expanding pressure inside the nose. The pain is produced because the balloon is expanded with much more pressure than needed to compress a bleeding vessel. The increased pressure is used to try to drive the balloon into the crevices or serpentine recesses of the nose. These recesses of the nose are the Superior Meatus, Middle Meatus and Inferior Meatus. Regardless of how much pressure is put into the balloon, the balloon will not flow into the crevices of the nose.
The XOMED™ Epistat™ balloon expands producing a round or ovoid configuration while producing significant pressure in a very small area, with significant pain, and does not fill much of the interior space of the nose such as the lateral crevices. There is not very effective filling of the posterior nose by the posterior balloon of the XOMED™ Epistat™. The balloon expands in about a sphere and takes on a modified configuration only when significant pressure is used in the balloon and it still does not fill much of the posterior airway, because the balloon does not match the anatomical configuration of the posterior nose.
The XOMED™ EPISTAT II™ was believed to have been produced in an attempt to stop bleeding without the need for an anterior nasal balloon. The anterior balloon is the balloon that causes most of the pain. The anterior balloon was replaced with a compressed “sponge” which expands when inserted into the nose. Although the EPISTAT II™ is much less painful, it is not very effective in stopping nosebleeds. The compressed sponge often lacks the force of expansion necessary to place sufficient pressure in the nasal cavities and recesses. There is no external force, such as water from a syringe, that drives the surface of the sponge into the recesses. Only the force of the sponge structure attempting to expand itself is available and this force is most often inadequate.
The present state of technology in medical devices for stopping serious nosebleeds is inadequate since the current devices lack the ability to effectively flow into the recesses of the anterior nasal cavity or fill the posterior nasal cavity and use severe pressure with associated intense pain. Therefore, a need exists for a new medical device that will overcome these deficiencies.
SUMMARY OF THE INVENTION
The present invention will effectively flow into the recesses of the nasal cavity without severe pressure and the associated intense pain thus filling the anterior nasal cavity, meatus and posterior nose without causing significant discomfort. The present invention will provide an improvement over existing devices that do not fill the recesses of the nose, do cause significant pain and still do not stop nosebleeds very effectively.
The objectives are achieved through the design of a nasal catheter system to stop a nosebleed comin
Muromoto Jr. Robert H.
Park John K.
Park & Sutton LLP
Worrell Danny
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