US 3516407 A
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June 23, 1970 s. RUGGERO 3,516,407
INFLATABLE INTRANASAL TAMPON Filed April 25, 1968 INF'L 1? TE P4154 44' 26 HIE J; Vania/ United States Patent 3,516,407 INFLATABLE INTRANASAL TAMPON Santo L. Ruggero, 7404 Hancock Drive, Wonder Lake, Ill. 60097 Filed Apr. 25, 1968, Ser. No. 724,104 Int. Cl. A61b 17/12 US. Cl. 128325 4 Claims ABSTRACT OF THE DISCLOSURE An inflatable intranasal tampon consisting of a flexible breathing tube having internal and external inflatable annular balloons thereabout in communication with each other and an external valve passage for inflating both of the balloons.
BACKGROUND OF THE INVENTION As is well known, nose bleeding can be severe and dangerous, and positivecontrol measures are frequently necessary. The general practice has been to pack the nasal cavity with absorbent material such as cotton, gauze, and the like until a clot is formed and healing commenced. The packing procedure is exceedingly uncomfortable and unpleasant for the patient and very unpleasant for the physician as well. When the bleeding is profuse, and persistent, a posterior nasal packing must be drawn into place by a cord extended through the mouth and over the soft palate into the nasopharyngeal cavity. Such procedure, it will be appreciated, is acutely uncomfortable and gives rise to a variety of reflux rejection responses which add greatly both to the difliculty and the discomfort. Along with this, the profuse bleeding makes the operation an exceedingly messy one for the physician or attendant to perform.
Furthermore, such packings block breathing through the packed side of the nose, and frequently both nasal cavities must be packed for adequate compression. Also, these packings must be removed within twenty four hours time, and, the fabric having become incorporated in the so recently formed clot, the lesion is frequently reopened upon such removal, so requiring a repacking.
Other inflatable intranasal tampons have been devised, but all of them lack the particular combination of characteristics of the invention presented here.
SUMMARY OF THE INVENTION This invention is directed to an inflatable intranasal tampon of simple and inexpensive structure which yet has the highly desirable characteristics of easy insertion and withdrawal, withdrawal without breaking open the lesion, permitting continued breathing and therefore a packing of both sides of the nose, of accurate retention in place, of. a controlled pressure of inflation so as to pack effectively without causing possibly painful excessive packing pressure, and of an external visible index that the tampon is inflated and inflated with the desired pressure. Another area of use to which this device may be applied is in the reduction and immobilization of nasal fractures.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side elevation of an intranasal tampon embodying the present invention, shown partially in section as contained within the nasal cavity of a patient;
FIG. 2 is a section through the left hand end of the tampon of FIG. 1 'with inflating syringe attached showing a different form of inflation valve;
FIG. 3 is a similar section through the central and right hand portions of the tampon of FIG. 1 with the balloons thereof deflated;
FIG. 4 is a section taken along the line 44 of FIG. 1 looking in the direction of the arrows; and
FIG. 5 is a section taken along the line 55 of FIG. 1 looking in the direction of the arrows.
DESCRIPTION OF THE PREFERRED EMBODIMENT The intranasal tampon of the present invention is structurally related to an ordinary Foley catheter of the type consisting of a latex tube open at both ends, an inflatable balloon adjacent the internal end surrounding the tube, and a balloon inflating passage within the wall of the tube extending from the balloon to the external end and terminating in a normally closed branch through which air can be injected to inflate the balloon and anchor the catheter within the urinary bladder.
Accordingly, the tampon of the present invention is formed basically of flexible latex and consists of a tube 12 having a wholly open exterior end 14 and an interior end 16 having a blunt, soft, forward closure 18 and lateral apertures 20 just back of the closure 18 communicating openly with the bore 22 of tube 12. The wall 24 of the tube has an inflation passage or bore 26 therein extending longitudinally therethrough which terminates at its outer end in a spur or branch 28 diverging from the tube 12 proper adjacent the outer end 14 thereof. The spur as illustrated in FIG. 2 has a normally closed latex flap valve 30 therein and an open free end 32 adapted to receive closely the nipple 34 of a syringe 36. The flap valve 30 should be near enough the end 38 of the inflation spur so that the nipple 34 can reach and open the flap valve for purposes of exhausting air from the tampon.
An alternative inflation structure is shown in FIG. 1 wherein the inflation tube is closed by a self-sealing latex plug 40. A hypodermic needle 41 can be inserted through the plug both for inflating and deflating the tampon. For successive pumping strokes of the syringe, the inflation tube may be pinched shut between strokes to retain the air therein prior to the introduction of more air.
A loose sleeve 42, which constitutes the internal balloon, is annularly secured at its ends 44 and 45 to the tube in air-tight relation immediately next to the lateral apertures 20. This balloon will be of thin walled, elastic latex and capable of being inflated to lie snugly against the whole surface of the nasal cavity. It is desirable that the balloon be also longitudinally secured to the breathing tube 12 along a line 46 in order to hold the breathing tube adjacent one side of the inflated balloon. Since the nasal cavity is upwardly domed with a relatively flat bottom surface, this longitudinal seam holds the breathing tube adjacent the floor of the nasal cavity and positions it for less bending and hence easier breathing and locates the inserted end closure 18 in a more comfortable region and in a non-touching relationship within the nasal cavity. The surface of the internal balloon is desirably rough so as to provide for some drainage of nasal secretions. In a characteristic embodiment, the balloon will extend along the tube 12 about three inches. The inflation tube is open to the interior of the balloon as at 48 by a perforation of the exterior wall of the inflation passage 26.
The exterior balloon 50 is likewise comprised of a latex sleeve secured at its ends 52 and 54 annularly to the breathing tube 12. The Spacing between the balloons is about /2 inch. The exterior balloon is likewise in communication with the inflation passage by an opening 56 in the exterior wall thereof. The exterior balloon differs from the interior balloon in that it will be smooth, will have an effective length along the breathing tube of about inch, and will have a somewhat heavier wall.
The functions performed by the external balloon are three. A real possibility of loss of the tampon or indeed any packing exists to the rear of the nasal cavity in the direction of the nasopharynx. Mucus covered latex is very slippery and the nasal cavity enlarges toward the rear. Thus, not only will the pressure application be lost in the desired area, but the presence of the tampon in the nasopharynx will induce severe gagging. The spacing of the external and internal balloons is close enough so as to locate the portion of the breathing tube between them exactly on the nostril and so hold the internal balloon effectively against any movement.
The second function is that of a pressure control. Obviously the internal balloon should be inflated to such degrees that it lies in firm contact with all susceptible parts of the nasal cavity so as to subject a lesion, no matter where located, to a compression sufficient to stop the flow of blood. On the other hand, to apply any greater pressure than that necessary to perform this function will produce acutely greater discomfort. I have determined that a pressure on the order of 80 mm. Hg is sufiicient to produce the necessary coverage and to apply the necessary pressure without causing excessive discomfort. Accordingly, the elasticity or the wall thickness of the internal and external balloons should differ by this degree. Thus, as air is applied to the inflation passage, the internal balloon will inflate to the point where it is in general total contact with the nasal cavity and the unsupported surface of the balloon will be blown out to its elastic limit or to a point where the inflation pressure differential is equal to the determined value. At this time the external balloon will inflate and prevent over-inflation or excessive pressure in the internal balloon.
As its third function, it affords an indication that the internal balloon is not only fully inflated but fully inflated to the desired pressure. It will of course be continuously visible after the inflation to indicate the pressure is being maintained in the internal balloon.
It will be understood that the pressure limitation of the external balloon is not absolute. Where the lesion lies in an area not normally covered under the desired pressure, the internal balloon can be inflated further to stretch it into the area of the lesion. This will result in a greater stressing of the external balloon, but the tampon is adequate for such usage. The pressure limitation described will result in the blockage of the vast majority of lesions.
It will be appreciated that an embodiment only of this invention has been described above. In addition to certain structural variations which may suggest themselves to those skilled in the art, it is contemplated that the tampon will be manufactured in a variety of sizes, both as to the size of the breathing tube and the length of the internal balloon to accommodate different nasal cavity sizes.
1. An intranasal tampon comprising a flexible breathing tube open at both ends, an inflatable elastic sleeve surrounding said tube adjacent the inner end of said tube and having the ends thereof secured circumferentially to said tube, said sleeve being inflatable to fill and bear positively against the internal surface of a nasal cavity for the control of nasal hemorrhage, a second inflatable sleeve surrounding said tube and spaced outwardly of said first sleeve and having its ends secured circumferentially to said tube, means defining an inflation passage extending longitudinally of said tube isolated from the breathing passage of said tube and communicating with the interior of each of said sleeves, said inflation-passagedefining means terminating exteriorly in self-sealing means adapted to be opened for the introduction or relief of air from said inflation passage, said spacing of said sleeves being such that said outer sleeve engages the exterior of the nostril when said inner sleeve is properly contained within said nasal cavity when both said sleeves are inflated.
2. The combination as set forth in claim 1 wherein said internal sleeve is also joined to said tube along a longitudinal line.
3. The combination as set forth in claim 1 wherein said internal sleeve has a rough exterior surface.
4. The combination as set forth in claim 1 wherein the Wall of said external sleeve has means for stretching only after the pressure within said internal sleeve is on the order of mm. Hg.
References Cited UNITED STATES PATENTS 2,215,126 9/1940 McMillin 128325 2,493,326 1/1950 Trinder l28325 3,046,988 7/1962 Moreau et al. l28-325 L. W. TRAPP, Primary Examiner US. Cl. X.R. 128-342