Article for packing body cavities

Details Article for packing body cavities Article for packing body cavities

1998-09-11

2001-02-06

Weiss, John G. (Department: 3761)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C604S358000, C604S385180, C424S431000, C028S118000, C028S120000

Reexamination Certificate

active

06183436

ABSTRACT:

BACKGROUND OF THE INVENTION
This invention relates to an article for packing body cavities, comprised of a tampon and a containing cover or sheath.
In U.S. Pat. No. 1,732,697, Ryan discloses a medicated, compressed sponge that is adapted for insertion into the nose and that swells into contact with the irregular surface portions of the nasal cavity, when moistened. Similarly, Steven U.S. Pat. No. 2,179,964, Kriwkowitsch U.S. Pat. No. 3,049,125, Gottschalk U.S. Pat. No. 3,570,494, Doyle U.S. Pat. Nos. 4,030,504, 4,646,739, and Des. 287,880, Rangaswamy U.S. Pat. No. 4,568,326, Brennan U.S. Pat. No. 4,950,280, DeMane et al. U.S. Pat. No. 5,336,163, Korteweg et al. U.S. Pat. No. 5,584,827, and Sweden patent No. 220,978 provide nasal hemostats and the like. A commercial product, sold under the GARDLOK designation, consists of a monoaxially compressed sponge tampon, which is intended for insertion into a supplied finger cot. Medical, catamenial, and like devices are disclosed in the following representative patents: Gearon U.S. Pat. No. 1,537,992, Munro U.S. Pat. No. 2,110,962, Robell U.S. Pat. No. 2,499,414, McLaughlin U.S. Pat. No. 2,739,593, Maro et al. U.S. Pat. No. 3,084,689, Penska U.S. Pat. No. 3,306,294, Crockford U.S. Pat. No. 3,369,544, Burnhill U.S. Pat. No. 3,762,414, Davis et al. U.S. Pat No. 3,791,385, Rosenblatt U.S. Pat. No. 4,098,728, Hirschman U.S. Pat. No. 4,175,561, Cercone et al. U.S. Pat No. 5,466,231, Cercone et al. U.S. Pat. No. 5,556,391, Canada Pat. No. 550,047, and France Pat. No. 718,042.
Efficient hemostasis, such as after septal, sinus, or rhinoplastic surgery, or to abate nasal hemorrhage, requires the application of gentle pressure to ruptured major arteries and blood vessels over substantially all parts of the nasal cavity. Moreover, it is highly desirable that there be no (or at most minimal) adherence or attachment of the hemostatic device to the adjacent tissue, resulting from ingrowth of the tissue or other mechanisms, so as to facilitate removal without undue discomfort to the patient or injury to the site of healing. It is particularly desirable that desiccation, with the accompanying stiffening and hardening of the sponge material that occurs, be avoided so as to again facilitate withdrawal with minimal pain and injury.
It is not believed that the devices provided heretofore function entirely adequately in either or both of the foregoing respects, or in other respects discussed hereinbelow.
SUMMARY OF THE INVENTION
Accordingly, it is the broad object of the present invention to provide a novel body cavity-packing article, and in particular a nasal cavity-packing article, comprised of a dry, expansible, tampon component that is substantially isolated from contact with body tissue and is protected against desiccation.
A more specific object is to provide such an article that is effective to apply gentle pressure to substantially all parts of the packed cavity, including relatively inaccessible openings and recesses thereof.
Related objects of the invention are to provide such an article which avoids undue pressure in or overpacking of the cavity, which is readily and comfortably inserted, worn, and removed, and which is of relatively simple and inexpensive manufacture.
It has now been found that certain of the foregoing and related objects of the intention are attained by the provision of an article for packing a body cavity, comprising a sheath of smooth, supple, polymeric film (generally of fluid-impermeable character); a tampon continued within the sheath; and a retrieval element. The sheath has a containment portion with a closed posterior end and with structure defining an entrance aperture at its anterior end, and with perforations advantageously being formed along length of the containment portion between the anterior and posterior ends. The entrance aperture structure lies substantially in a transverse plane and has a peripheral dimension that is substantially smaller than the peripheral dimension of any cross sectional element, taken along the length of the containment portion and lying in a plane parallel to the plane of the aperture structure. The tampon is of elongate form and is loosely disposed within the containment portion of the sheath; it is comprised of an absorbent material that is expansible when wetted from a dry, compressed state, and is compressed in two directions that are perpendicular to one another as well as to the longitudinal axis of the tampon. The retrieval element extends from adjacent the anterior end of the sheath, and is operatively attached for effecting withdrawal of the tampon from the containing body cavity.
In certain embodiments the sheath will include an anterior portion that extends outwardly from the anterior end, in a direction away from the containment portion. Such an anterior portion may serve as both an anterior end closure and also as a retrieval element, and it will desirably be elongate and of reduced transverse cross section (usually having a peripheral dimension the same as that of the entrance aperture structure, taken in planes parallel to the plane thereof). The sleeve will advantageously be configured to correspond generally to the shape of the body cavity in which the article is to be contained. The film from which the sheath is made will preferably have a thickness of about 0.5 to 3 mils and a Shore A Durometer value in the range of 20 to 60 (and preferably 30 to 45); in most instances it will comprise a biocompatible polymer, such as a medical or surgical grade of latex, silicone, polyolef in, polyurethane, or polyester.
The absorbent material comprising the tampon of the article will normally be an open-cell sponge, such as of cellulose, polyvinyl alcohol, polyvinyl acetal or formal, polyurethane, or other suitable (usually hydrophilic) material; combinations of different sponge materials may be employed so as to impart variations in composition, density, porosity, and the like. In compressed form the tampon will desirably have a substantially rectangular cross section, taken in planes transverse to its length dimension. The sheath will advantageously be dimensioned and configured to contain the fully expanded tampon without significant distortion of one component by the other, albeit that in some instances differential compression by the sheath may beneficially provide areas of the sponge having different effective densities.
In certain preferred embodiments the article will additionally include a hollow tube extending between the anterior and posterior ends of the sheath containment portion, and usually through the tampon as well, to provide an airway through the article. At least the posterior end of the sheath will, in such instances, sealingly engage the tube, and an aperture may be provided thereat to receive the corresponding end portion of the tube. Inherent elasticity of the polymeric film may be relied upon to cause the surrounding structure to grip the tube circumferentially, and a similar arrangement may be present at the anterior end.


REFERENCES:
patent: 4030504 (1977-06-01), Doyle
patent: 4341214 (1982-07-01), Fries et al.
patent: 4883465 (1989-11-01), Brennan
patent: 4925453 (1990-05-01), Kanankeril
patent: 5336163 (1994-08-01), Demane et al.
patent: 5466231 (1995-11-01), Cercone et al.
patent: 5556391 (1996-09-01), Cercone et al.
patent: 5584827 (1996-12-01), Korteweg et al.
P. 318—Week Catologue.

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