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 improves that of the earlier art, hereinafter disclosed, by the addition of a shrouding adjunct that lessens the likelihood of urethra contamination. It also includes aids for handling and emptying the collector. The principal distinction of this invention is that it entertains the use of a shorter catheter, in a diminutive shroud-conduit-collector package that may be used for self-catheterization by paraplegics.
2. Discussion of Relevant Art
There exists in the field a need for an apparatus that will 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). Further, the individual performing this auto-procedure should be able to collect a clean specimen, truncate both procedure and apparatus conduction (i.e., fluid flow to a collector) and resume voiding into a portable urinal that is often close to, or part of, the wheelchair apparatus. Although art exists that will allow aseptic or sterile catheterization and uncontaminated fluid collection/containment, and ready disposability of the apparatus, there does not exist the unique combination of elements seen in the instant invention for accomplishing the aforesaid auto-procedure.
Over thirty years ago, I suggested catheterizing a patient with a catheter that was itself prevented from contacting the wall of the urethra, until it had passed into uncontaminated portions of the urethra. To achieve this, an envelope or shroud, i.e., a sterile barrier is interposed the catheter and the urethra wall. The apparatus used consisted in a standard catheter enveloped, at its distal portion, in a tubular membrane (the shroud). A short portion of the shroud is initially passed into the catheter""s distal orifice and stored in the catheter. Upon insertion of the catheter distal end into the urethra, with concomitant mechanical or manual retardation of the shroud, the stored shroud is withdrawn from the catheter. This withdrawal of the shroud, as the catheter advances, causes a simultaneous interposition of the shroud between the catheter and wall of the urethra. As may be reckoned, the use of the shroud is no longer novel; however, the instant invention places it to the (self) application mentioned in the Field of the Invention and provides several adjuncts to my basic shroud-conduit-collector combination.
Before discussing the art relevant to my reasons for eclipsing the early shroud usage, I will discuss all the pertinent features of my U.S. Pat. No. 3,421,509 (""509), for an URETHRAL CATHETER. It 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, which is inserted in and extracted out of the catheter, as its distal end is advanced into the urethra. To facilitate withdrawal of the envelope, an annular sleeve and guard portion or collar, which is attached to a hem of the envelope, is provided to slide over the catheter. As the catheter advances (forward) into the urethra, the sleeve is urged rearward, towards the catheter""s proximal end, by manipulation or mechanically by contact against the glans/urethra orifice, and the envelope is extracted. The envelope, or shroud, of this invention does not include an integral container and it is the catheter that provides a conduit to the collection reservoir. This arrangement necessitates use of an introducer element which, like the catheter conduit and collector, is not wholly one piece with the envelope/shroud. Finally, a limitation extant in all shrouded catheters of the present day is likewise present in ""509; namely, the tip orifice of the catheter may pick up effluvial contamination within the urethra as it incipiently transits the duct. Quite possibly, the contamination will be carried into the bladder and, most likely, it will be passed into the non-contaminated portions of the urethra. All subsequently discussed art suffers this limitation and, considering my purpose for which the instant invention was made, much more.
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. It is not a container, in the conventional sense, and does not do what is desired by the instant inventor. 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. 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 xe2x80x9cshroudxe2x80x9d) 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.
None of the current art reveals a single-piece shroud-conduit-collector nor, for that matter, a single-piece shroud-collector, that is small enough to be used by the patient him/herself. Moreover, nowhere in the art is there disclosed a one-piece apparatus for the aseptic enshroudment of a catheter, conduction of body fluids to, and a reservoir for, those fluids. Finally, it can be seen that even shrouded catheters do not avoid the aforementioned limitation of ""509, entry of contamination into the shrouded catheter tip.
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.
Most terms are defined parenthetically herein or may be determined by context and by referring to the drawings of both incorporated references and the instant art. A few terms and their synonyms or analogs are defined:
xe2x80x9casepticxe2x80x9d is used synonymously with xe2x80x9csterilexe2x80x9d;
xe2x80x9cbulbousxe2x80x9d means expansive and does not connote a particular form or shape;
xe2x80x9ccollarxe2x80x9d means an encircling or girdling element or surface relief; such an element in the present invention, a relieved surface, serves as a manipulative device;
xe2x80x9cenvelopexe2x80x9d means the flexible, membranous subject of the invention, also the words xe2x80x9csheathxe2x80x9d or xe2x80x9cshroudxe2x80x9d;
xe2x80x9cintegral with/toxe2x80x9d means within the unit in the forming or making of an object;
xe2x80x9cmonolithicxe2x80x9d has the meaning given it in the BRIEF SUMMARY OF THE INVENTION;
xe2x80x9cone-piecexe2x80x9d means a single continuous unit, whether formed monolithically or formed, molded or cast in separate sections that are joined subsequently by suitable means;
xe2x80x9cproximalxe2x80x9d refers to a device""s portion that is inserted into the body, i.e., in this invention, closer(est) to the human body (urethra) being catheterized;
xe2x80x9csingular piecexe2x80x9d means the same as xe2x80x9cone-piecexe2x80x9d; and
xe2x80x9cwhollyxe2x80x9d or xe2x80x9cunitaryxe2x80x9d mean the same as xe2x80x9cone-piecexe2x80x9d or xe2x80x9csingular piecexe2x80x9d.
The basic device on which the herein disclosed improvements are made consists in a singular piece of fluid-impervious, membranous envelope that may be continuously formed, of a single substance, to provide a catheter shroud- (or sheath-) fluid conduit-collector. The latter is a concatenated, short-necked reservoir. Alternately, the invention consists in a singular piece realized by a continuous structure wherein the three distinct portions thereof are physically joined, one to the other(s), by any of the contemporary manufacturing processes such as adhesion, cohesion or welding. In keeping with a standard adopted in the Patent Office, I refer to the first, continuously formed article, as xe2x80x9cmonolithicxe2x80x9d and the second, continually or piecemeal formed, simply as xe2x80x9cintegralxe2x80x9d or xe2x80x9cunitaryxe2x80x9d. Neither of these two embodiments are seen in the art; and, also novel is the likely usage of a short catheter (about 10-12 cm.) that is, when used properly, one which may be preponderantly disposed in the urethra, with but 2-5 cm. anticipated to remain outside, to facilitate finger-tip withdrawal. In its normal, ready-to-use configuration, the catheter is enshrouded by the shroud portion and part of the fluid conduit portion, the latter portion being storable on the rear part of the catheter, as an aid in packaging. Should it suit the manufacturer, for ease of sterilization and compactness in packaging, the entire conduit and collector may also be placed onto the catheter; however, this is a storage, rather than an operative mode. In operation, the catheter does not join the collector. This is most important because integrity of the conduit-collector section is violable and, after it is filled with fluid, the collector is readily separable from the conduit portion, unhindered by the catheter. This is done with little physical effort by the paraplegic user, because the catheter device is itself not integrated with the collector. As reference to this disclosure""s priority document will show, a portion of the shroud is initially disposed in the proximal end of the catheter and is withdrawn as the latter is pressed into the urethra. As it leaves the catheter proximal end, the shroud is interposed the catheter and the urethra wall, its primary purpose being to provide a sterile path for the catheter as it transits the urethra into the bladder. To statically maintain the conduit during catheter insertion, as well as separation and closure of the collector from the ensemble proper, suitable adjuncts are provided such as a distal surface relief on the shroud exterior, a rending facility and a tongue-in -groove closure, respectively.
Differing from the above described and original, xe2x80x9cbasicxe2x80x9d device are the shroud and adjuncts of the instant invention. First and foremost, the shroud, which is disposed in the catheter proximal end, bears near that end, a plurality of tabs or leaves that are attached by their distal margins to the circumference of the shroud exterior. The leaves are stylistically folded (overlapping or interleaving) over the shroud-enveloped proximal end of the catheter. This interleaving of integral shroud portions (hereinafter, xe2x80x9cleavesxe2x80x9d) operatively effects a continuous sheathing of the catheter as it is initially pressed into the urethra, thus avoiding possible infusion of urethra secretions into the proximal opening of the incipiently inserted (and shrouded) catheter. Thereafter, the shroud portion""s distal end is maintained static by the user""s fingertips and the catheter is advanced further into the urethra and into the bladder. The rending and closure adjuncts, mentioned above, are maintained; and, additionally a handle and an evacuation device are added to the collector portion.
The evacuation device is a mechanism that is positioned at most any place on the collector to facilitate emptying of the reservoir. It consists, primarily, of a flanged annular guide or jig, fixed to the collector surface and a flanged annular chisel, positioned in the guide and held off the surface by a cushion interposed between the flanges. Pressing the chisel toward, and compressing, the cushion effects a piercing of a seal or the collector surface.