A portion of the disclosure of this patent document contains material which is subject to copyright protection. This patent document may show and/or describe matter which is or may become trade dress of the owner. The copyright and trade dress owner has no objection to the facsimile reproduction by anyone of the patent disclosure as it appears in the Patent and Trademark Office patent files or records, but otherwise reserves all copyright and trade dress rights whatsoever.
The present invention relates to an intermittent urinary catheter system and, more particularly, to a dual-purpose urinary catheter drain line and collection bag.
People with neurogenic bladder disorders like spinal cord injury, spina bifida or multiple sclerosis, and non-neurogenic bladder disorders like obstruction due to prostate enlargement, urethral strictures or post-operative urinary retention, need to be continuously catheterized to empty their urinary bladders. But such continuous catheterization can lead to problems like urinary tract infections (UTI), urethral strictures or male infertility. Intermittent catheterization at regular intervals avoids such negative effects of continuous long term catheterization. Research has shown that intermittent self-catheterization helps reduce urinary tract infections, control urinary leakage (incontinence) and prevent urinary tract damage.
In our highly mobile culture, the ability to have the freedom to leave home for the day or longer is an important part of life. To accommodate this need, single use intermittent urinary catheters have been developed to allow patients to perform self-catheterization. Many intermittent catheters are designed to be inserted into the bladder while the back end is suspended over a toilet or other waste receptacle. For example, the mPower Cath Hydro hydrophilic intermittent urinary catheter available from Adapta Medical of Colorado Springs, Colo. provides a sterile catheter surrounded by an elongated flexible sheath. The catheter may be extracted from one end of the sheath, which collapses in pleats, for insertion in a urethra of a user. Urine drains through the catheter and flows out an opposite end outlet to be directed into either a toilet or a collection bag. Various aspects of such catheters may be seen in U.S. Pat. Nos. 6,090,075, 8,177,774 and 8,845,620.
On the other hand, a closed system catheter is a self-contained, sterile, pre-lubricated catheter housed within a collection bag. The collection bag eliminates the need to void the urine into a receptacle or toilet, and since it is self-contained, it eliminates the need to hook up any other kind of bag or container—it is truly portable.
Despite numerous products on the market, there remains a need for a more adaptable intermittent urinary catheter system.
The present application discloses a sterile dual-purpose intermittent urinary catheter system that may be used as either a drain line or a collection bag. In one embodiment, a catheter having a length resides within an inner cavity of an extensible sheath. The sheath is sealed at both ends and the catheter may be extracted from a forward end through a hub for insertion into the urethra. A valve at a rearward end of the sheath may be opened to permit the sheath to function as a drain line, or closed to permit the sheath to function as a collection bag. The sheath has an extended length substantially longer than the catheter length.
The present application provides a closed system catheter which may be used in two ways and is thus dual-purpose. In a first mode of operation, the catheter provides a closed bag or sheath and a pre-lubricated catheter that may be extended therefrom. The user inserts the catheter into his or her urethra and thus may empty the bladder into the closed bag. In a second mode of operation, a back end of the bag may be opened so that the user can drain the flow into a convenient receptacle, such as a toilet. The bag is preferably highly extendible to provide a relatively long drain line. Conversion between the two modes is accomplished by actuating a valve incorporated into the bag.
In the storage and shipping configuration seen in
The intermittent urinary catheter 24 extends from a forward tip 34 to a rear funnel or enlargement 36, and has a length which is less than the longitudinal dimension of the sheath 22, even when constricted. The catheter 24 is typically 14 or 16 inches in length, but may be less or more as desired. As the length of the catheter 24 is shorter than the length dimension of the sheath 22, the catheter is fully contained in a sterile manner within the sheath. Further, the assembly as shown in
With reference to the forward end 26 of the system in
The feed lock 48 functions to permit one-way forward advancement of the catheter 24, but inhibits rearward movement thereof. Exemplary feed locks are disclosed in co-pending U.S. Patent Publication No. US 2019/0046766, the contents of which are hereby expressly incorporated by reference. It should be noted that rather than providing the lubricating gel reservoir 46, the catheter 24 may be pre-lubricated along its length, or may be provided with a dry hydrophilic coating which, when wetted, becomes lubricious. In the latter case, a small sachet of water is provided within the sheath 22 which, when ruptured, wets the catheter 24.
At the rear end of the system 20, an exemplary fluid valve has a housing 50 with a drain 52 on an outlet end, a shaft stub (not shown) over which the rear end of the sheath 22 seals, such as with the stricture 33, and an actuator 56 which opens and closes the valve. The illustrated embodiment shows a simple piston/cylinder type of valve with a plunger-type of actuator 56 that moves linearly through the tubular housing to alternately occlude and open an internal throughbore between the drain 52 and shaft stub. As shown, the plunger actuator 56 is partially retracted out of the housing 50 to close the valve and maintain the inner contents of the sheath 22 sterile. Of course, other such fluid valves are contemplated, such as a stopcock, pinch valve, slider type of actuator, etc.
In use, after removal of the cap 40 and prior to longitudinal advancement of the catheter 24 from the sheath 22, the user inserts the introducer tip 44 into the urethra (men or women). The user then advances the catheter 24 forward, as indicated by the arrow in
Eased by the lubricated nature of the catheter 24, the user continues to slowly push the catheter 24 through the introducer tip 44 and into the urethra until the catheter reaches the bladder and urine begins to flow. The catheter 24 has one or more small eyelets (not shown) at its distal tip 34 into which the urine flows. The enlarged funnel 36 prevents complete extraction of the catheter 24 from within the sheath 22 as it abuts the internal components of the forward hub 28. Urine flows through the funnel 36 into the inner cavity of the sheath 22.
In
The rigid outlet hub 128 may be configured in a similar manner as the outlet hub 28 described above, and in particular preferably includes a movement control valve 130. The movement control valve 130 may be configured as an angled flap with a hole therethrough. Various such movement control valves 130 are disclosed in U.S. Patent Publication No. 2019/0282782 to Palmer, which is expressly incorporated herein.
As the catheter 124 advances distally through the hub 128, the flap flexes so as to be perpendicular to the catheter, which permits relative movement. However, if the catheter 124 is displaced in the opposite direction, proximally, the flap flexes to the angled configuration shown which impedes relative movement of the catheter. This serves to enable the user to displace the catheter 124 forward in increments with the movement control valve 130 preventing catheter retraction between incremental movements.
In addition to a movement control valve, the outlet had 128 may also house a lubricating gel reservoir, the catheter 124 may be pre-lubricated along its length, or may be provided with a dry hydrophilic coating which, when wetted, becomes lubricious. In the latter case, a small sachet of water may be provided within the sheath 122 which, when ruptured, wets the catheter 124.
A rearward end 132 of the system 120 houses a drain valve 134. The drain valve 134 may be as described above, and preferably is mounted within a rigid housing 136. The outer sheath 122 surrounds the rigid housing 136 and is desirably bonded thereto using heat welds, adhesives, or the like, shown as two bond lines 140. Likewise, the rigid outlet hub 128 is received within the outer sheath 122 and secured thereto at bond lines 142, which again may be heat welds, adhesives, or the like. In this manner, a sealed inner volume is formed within the outer sheath 122 between the outlet hub 128 and housing 136 of the drain valve 134. This sealed inner volume comprises a reservoir for urine should the system 120 be used as a collection bag.
With reference back to
The width dimension W equals one half of the circumference of the tubular form of the outer sheath 122, seen in
2×W=π×D=C, where D is the diameter of the tube and C the circumference, and
V=πr2×LR=W2/π×LR, where V is the volume of the reservoir for urine.
In a preferred embodiment, the outer sheath 122 has a diameter D of between 1-2 inches (2.54-5.08 cm), and an initial or extended length L of between 24-45 inches (61-114 cm). Moreover, the length of the catheter 124 is desirably between about 12-30 inches (30.5-76.2 cm). The shorter length LR of the reservoir is desirably also between about 12-30 inches (30.5-76.2 cm) to accommodate the full length of the catheter 124 without having to curl or otherwise bend the catheter within the elongated sheath 122. Consequently, the volume V of the portion of the inner cavity available as a reservoir for urine is between about 0.061-0.101 L for thinner sheaths having a diameter of 1 inch, and 0.243-0.405 L for wider sheaths having a diameter of 2 inches. Of course, the length and width of the sheath 122 can vary, and may be larger than 2 inches. Preferably, the volume V of the reservoir for urine is somewhere between 0.061-0.5 L, which equates to about 2-68 fluid ounces. Of course, it is unlikely that someone will use a short thin catheter system 120 as a reservoir since the volume will be relatively small. In that case, the dual-mode catheter system 120 will more likely be used as a drainage tube, as will be explained.
With reference again to
A line of weakness or score line 154 extends laterally across the forward segment 150 immediately adjacent to the outlet hub 128. Furthermore, a finger hole 156 is formed in a midportion of the forward segment 150, typically by heat sealing in the pattern of the hole and then cutting or stamping out the material circumscribed thereby. A second finger hole 158 is similarly formed in a midportion of the outer sheath 122 in the rectangular region between the outlet hub 128 and the housing 136 of the drain valve 134. A user may easily separate the forward segment 150 from the remainder of the outer sheath 122 by grasping the finger hole 156 in one hand and either the outlet hub 128 or second finger hole 158 and pulling. The score line 154 easily severs, resulting in exposure of the forward or distal end of the outlet hub 128.
In this manner, the user can easily prepare the catheter system 120 for use. That is, the user inserts an introducer tip 160 into the urethra (men or women) and advances the catheter 124 forward by pinching it through the relatively flexible sheath 122 and urging it forward while holding the outlet hub 128 steady. Without any other preparation, the system 120 can thus be used as a collection bag. Another advantage is that the drain valve gives better control than just a tear open spot on the bag with less splashing and misdirected urine.
In a second mode of operation, the catheter system 120 can be used as a drain line. The outer sheath 122 includes an elongated rearward segment 170 adjacent to the housing 136 and drain valve 134. Again, longitudinal and parallel edges 144a, 144b continue along the rearward segment 170, and terminate at a lateral edge 172. A finger hole 174 is formed adjacent the lateral edge 172, and a lateral line of weakness or score line 176 provided toward the housing 136. A second finger hole 178 is again provided in the outer sheath 122 between the housing 136 and score line 176. By grasping the finger hole 174 and pulling, while also holding either the housing 136 or second finger hole 178, a user can easily detach a portion of the rearward segment 170, thus opening the inner cavity of the outer sheath 122 and exposing the drain valve 134.
The extended length L of the outer sheath 122 is sufficiently long so as to extend from the outlet hub 128 held by a user while seated adjacent and not on a toilet to the severed rearward segment 170 suspended over the toilet. By manipulating the drain valve 134 to the open position, a user can then directly urinate into the toilet. Oftentimes, the length of the outer sheath 122 is long enough such that the drain valve 134 is also positioned over the toilet, in which case the weight of the valve helps to keep the rearward end within the toilet.
It should be understood that the catheter system 120 can also the utilized both as a collection bag and has a drain line. That is, the drain valve 134 can remain closed while the user advances the catheter 124 and urinates, thus filling the reservoir volume between the outlet hub 128 and the housing 136. Once finished, the user typically retracts the catheter 124 from the body and disposes of the entire system with the urine in a trash receptacle. However, in cases where a toilet or other waste receptacle is readily accessible, the user can instead position the open rearward segment 170 of the outer sheath 122 and open the drain valve 134 to empty the contents of the system. That is, the system 120 thus functions as a temporary collection bag just long enough for the user to empty the reservoir into the toilet. This may be preferable, for example, where the user has limited dexterity and has a hard time draining the system in the toilet while urinating, and must perform the task in two steps. Subsequently, the empty system 120 is disposed of in a trash receptacle.
As seen in
To utilize the system 120, the user removes the shipping seal 190 and unfolds the system once into the configuration of
Throughout this description, the embodiments and examples shown should be considered as exemplars, rather than limitations on the apparatus and procedures disclosed or claimed. Although many of the examples presented herein involve specific combinations of method acts or system elements, it should be understood that those acts and those elements may be combined in other ways to accomplish the same objectives. Acts, elements and features discussed only in connection with one embodiment are not intended to be excluded from a similar role in other embodiments.
This application is a continuation-in-part of U.S. patent application Ser. No. 16/352,538 filed Mar. 13, 2019, now issued as U.S. Pat. No. 10,531,976, which is a continuation of U.S. patent application Ser. No. 15/956,561 filed Apr. 18, 2018, the disclosures of which are expressly incorporated herein by reference.
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Parent | 16352538 | Mar 2019 | US |
Child | 16740865 | US |