Surgery – Means or method for facilitating removal of non therapeutic... – Urinary catheter
Reexamination Certificate
1999-05-10
2001-04-17
Nguyen, Anhtuan T. (Department: 3763)
Surgery
Means or method for facilitating removal of non therapeutic...
Urinary catheter
C604S171000, C604S271000, C604S544000
Reexamination Certificate
active
06217569
ABSTRACT:
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not Applicable
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to devices that are used in connection with catheters and, specifically, to membranous shrouds or envelopes that are employed to cloak a catheter in order to facilitate sterile (aseptic) insertion of such into a bodily passage. The shroud, or envelope, of the present invention eclipses the extant art by combining with it an integral, yet detachable, container element.
2. Discussion of Relevant Art
There exists in the field a need for an apparatus that will allow a medical professional to aseptically catheterize and withdraw a clean urine specimen from a patient, or allow one limited physically, say by paraplegia, to perform self catheterization and void the bladder, either fully or partially (e.g., taking a specimen sample). Although art exists that will allow aseptic or sterile catheterization and uncontaminated fluid collection/containment serially, there does not exist a combination of shroud, i.e., a sterile barrier interposable between the catheter and wall of the body passage being penetrated, and the containment element, so that these activities might be accomplished simultaneously with a unitary/singular device and under sterile conditions. The absence of such a combination does not deter medical providers so much that it hinders self-collection by those having physical limitations (ibid).
A consideration of the relevant art must begin with my U.S. Pat. No. 3,421,509 ('509), for an URETHRAL CATHETER that discloses a catheter which has inserted in its distal end (i.e., with respect to the user, who manipulates the device from its proximal end) a membranous (tubular) envelope that is extractable out of the catheter, as its distal end is advanced into the urethra. To facilitate withdrawal of the envelope, I provide an annular sleeve and guard portion, much like a collar, to slide over the catheter and which is attached to a hem of the envelope. As the catheter advances (forward) into the urethra, the sleeve is urged rearward, towards the catheter's proximal end, by manipulation or by contact against the glans/urethral orifice, and the envelope is extracted. The envelope, or shroud, of this invention does not include an integral container, but is made to engage with and connect to a pouch via the rear end of the guard portion. Such an arrangement necessitates use of an introducer element, which is non-integral to the envelope or the pouch.
Another sheathed catheter is disclosed in U.S. Pat. No. 4,652,259 ('259), entitled CATHETER ASSEMBLY. This disclosure shows a catheter disposed within an outer sheath, the outer sheath composed of two co-linear tubular members. A containment feature, providing a flexible shroud, is in reality a sterile covering that encloses the juncture of the two tubular members. Thus, its function is to maintain sterile conditions within the sheath proper and is not a container, in the conventional sense. Also relevant to the instant invention is U.S. Pat. No. 5,531,717 ('717) for NON-CONTAMINATING PROBE AND METHODS OF MAKING AND USING SAME, a sheathed catheter assembly. This patent discloses an annular collar that is attached to a hem of a sheath member and is provided in order to allow the user to manipulate (the extraction of) the sheath. However, a series of drawings in the disclosure reveal that the collar is an adjunctive construct, and not integral to the sheath. My more recent patent, U.S. Pat. No. 5,792,114 ('114), for INTRODUCER FOR STERILE INSERTION OF CATHETER, also employs a non-integral collar. The envelope (termed “shroud”) therein is distinctive over the envelopes or sheaths of the aforementioned patents in that it has only one open end; but, the closed end, although possessing a small cavity, cannot be said to contain an integral fluid receptor/collector. Furthermore, the integrity of this closed-end design is violated by the operational introduction of the catheter.
Incorporation by Reference
Because of their relevance to certain features of the instant invention, as well as their provision of background art and terminology, the following previously discussed U.S. patents are hereinafter incorporated by reference: U.S. Pat. No. 3,421,509, entire disclosure; U.S. Pat. No. 4,652,259, column 2 and
FIGS. 1 and 6
; U.S. Pat. No. 5,531,717,
FIGS. 2-9
,
12
,
13
and columns 1 and 2; and U.S. Pat. No. 5,792,114, entire disclosure.
Definitions
Most terms are defined parenthetically herein or may be determined by context and by referring to the drawings of both prior and the instant art. A few terms and their synonyms or analogs are defined:
“aseptic” is used synonymously with “sterile”;
“bulbous” means expansive and is not meant to connote a particular shape;
“collar” means an encircling or girdling element; as an element in the present invention, it serves as a manipulative device;
“distal(ly)” refers to a device's portion that is inserted into the body, i.e., most distant from a (medical) practitioner who would ordinarily use it;
“envelope” means the flexible, membranous subject of the invention, also “sheath”, “shroud”;
“integral with/to” means “unitary” in the formation or realization of an object; and,
“lumen” refers to a thin tube or conduit.
BRIEF SUMMARY OF THE INVENTION
Having sought, for years, to improve catheter apparatus that would promote and advance the insertion of a sterile lumen into the body, I have chosen to improve on the devices for collection of fluids that are conducted out of the body, through the lumen. More importantly, in overcoming the limitations of prior art, I have provided an integral shroud-collector that can be self-employed rather easily by a paraplegic, particularly when that person must withdraw a small amount (specimen) for analysis.
The shroud-collector is employed with a relatively short catheter of a size that can be easily handled by a person during self-insertion and when only a small collection means or container is used. This is a single situational preference, however, and is not to be viewed as a limitation of the invention. Should longer catheters be desired, particularly for general clinical usage, longer shrouds and larger, suspendable containers are to be employed.
The shroud is the entire continuous membranous, tubular envelope that has an open end, which is disposable into the distal end of the enveloped catheter, and a closed end, which is distended (bulbous) and serves integrally as a pouch /container, called a collector. An integral collar or (simply) relieved exterior surface is provided to the shroud, positioned about the distal end of the catheter, and is used to extract the shroud from the catheter during the latter's insertion, pursuant to the teachings and techniques of my previous patents (ibid) and current application. Between the collar or relieved surface and the pouch/container, an integrally formed separation mechanism, such as a tear strip or rip band is formed so that the collector may be readily separated from the shroud proper. To aid collection, particularly in cases of self-service, there is incorporated a self-sealing means, a cement or mechanical closure, in the neck portion of the collector, between the latter and the separation mechanism.
REFERENCES:
patent: 3421509 (1969-01-01), Fiore
patent: 3672372 (1972-06-01), Heimlich
patent: 3881199 (1975-05-01), Treace
patent: 3894540 (1975-07-01), Bonner, Jr.
patent: 4043345 (1977-08-01), Kramann et al.
patent: 4062363 (1977-12-01), Bonner, Jr.
patent: 4170996 (1979-10-01), Wu
patent: 4652259 (1987-03-01), O'Neil
patent: 4957485 (1990-09-01), Andersson et al.
patent: 5531717 (1996-07-01), Roberto et al.
patent: 5792114 (1998-08-01), Fiore
Morellex Fredric
Nguyen Anhtuan T.
Thompson Michael M
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