Patent Application
20120184944
1. Technical Field
This invention relates generally to catheter systems, and more particularly to a tubing apparatus and drain bag suitable for use as a Foley catheter assembly.
2. Background Art
Conventional catheter devices employ a thin sterile tube that is inserted into a patient for the purpose of draining bodily fluids. For example, a Foley catheter includes a thin tube that is inserted into a patient's bladder for the purpose of draining urine. The urine flows through the tube and generally collects in a drain bag attached to the tube opposite the patient.
Turning to
A frequent problem with prior art catheter systems 100 involves the catheter tube 103. As shown in the expanded view 105 in
It would be beneficial to have a catheter assembly capable of overcoming these issues.
Skilled artisans will appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of embodiments of the present invention.
Embodiments of the invention are now described in detail. Referring to the drawings, like numbers indicate like parts throughout the views. As used in the description herein and throughout the claims, the following terms take the meanings explicitly associated herein, unless the context clearly dictates otherwise: the meaning of “a,” “an,” and “the” includes plural reference, the meaning of “in” includes “in” and “on.” Relational terms such as first and second, top and bottom, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, reference designators shown herein in parenthesis indicate components shown in a figure other than the one in discussion. For example, talking about a device (10) while discussing figure A would refer to an element, 10, shown in figure other than figure A.
As noted above, when a dependent loop of tubing forms in drain bag tubing, problems can arise. This is due in part to the fact that fluid passing through the tubing is forced to flow against gravity to reach the distal end of the tube. The formation of dependent loops is frequently due to the fact that the tubing must be sufficiently long to permit patient movement. When the drain bag is coupled to a bed, walker, rolling stand, or other device, and is not fully using the length of the tubing, excess tubing is falls into one or more dependent loops. As patients come in different sizes and shapes, and as patients reside in differently shaped devices (i.e., beds, wheelchairs, etc.), it is not possible to custom fit the tubing length to prevent the formation of dependent loops. Prior art attempts to do so have resulted in limited patient mobility and movement, discomfort, and other problems.
Embodiments of the invention provide a robust solution to the dependent loop problem by including a helical section in the tubing material of a catheter system. In one embodiment, the helical section is configured as a spring coil that is integrated with substantially straight sections of tubing. In one embodiment the helical section can expand and contract, thereby letting the overall tubing length change without the formation of dependent loops. This provides the patient with adequate mobility without the risk of pooled urine or air-fluid locks. In one embodiment, the helical section is operable with a bag hanger configured to stiffen and retain the helical section in an upright position such that fluids passing through the tubing always flow in the direction of gravity. Accordingly, a drain bag connected to the tubing with the helical section can be placed in different locations without losing the advantage of gravity for the collection of fluids.
Turning now to
In one embodiment, the drain tubing 201 is manufactured from a flexible tubing material. One suitable flexible tubing material is polyvinyl chloride, which is also known as “PVC.” In one embodiment, the drain tubing 201 is manufactured from 90A PVC. Other materials may used as flexible tubing material as well, including polyurethane, nylon, polyester, customized elastomers, customized polymers, thermoplastic elastomers, and so forth.
In one embodiment, the drain tubing 201 includes three sections having different geometrical configurations: a first elongated section 205, a helical section 206, and a second elongated section 207. The first elongated section extends distally from a first end 208 of the helical section 206 towards the catheter connector 203. In one embodiment, the first elongated section 205 terminates at the catheter connector 203. In another embodiment, the first elongated section 205 can include an integrated catheter assembly.
The second elongated section 207 extends distally from a second end 209 of the helical section 206 towards the drain bag 202. In one embodiment, the second elongated section 207 terminates at the inlet connection 204, which functions as a drain bag connector. The second elongated section 207 can be integrally formed with the drain bag 202. Alternatively, a selectively detachable component such as the inlet connection 204 of
In one embodiment, the helical section 206 comprises a plurality of turns that form a coil. For example, in the illustrative embodiment of
In one embodiment, the coil is configured so as to be expandable. Said differently, the length of the helical section, and thus the length of the overall connector formed by the flexible tubing material, is configured to be alterable by pulling the first elongated section 205 away from the second elongated section 207. Such a pulling action, as may be caused when a patient having the drain tubing 201 inserted in his bladder turns over, alters an axial length 210 of the helical section 206 by expanding the coil. In the illustrative embodiment of
In one embodiment, the first elongated section 205, the helical section 206, and the second elongated section 207 are integrally formed together with a unitary piece of flexible tubing material. In another embodiment, one or more of the sections is formed as a separate component. Illustrating by example, in the exemplary embodiment of
In one embodiment, where one or more of the first elongated section 205, the helical section 206, and the second elongated section 207 are separate, they can be configured with different inside and/or outside diameters to further enhance the flow of fluid therein. In the illustrative embodiment of
In one embodiment, the first elongated section 205 has a fluid-conveying aperture that is greater than the fluid-conveying aperture in the helical section 206. For instance, the first elongated section 205 may have a diameter of about 6.5 millimeters while the helical section has a diameter of about 6.3 millimeters. This “wider first to narrower next” configuration works with gravity to assist the flow of fluids and prevent air-fluid locks from forming in the drain tubing 201. The different diameter of the first elongated section allows a direct flow of fluid from the patient to the helical section 206. The helical section 206 then “siphons” the fluid into the drain bag 202. The helical section 206 therefore provides a dual function of both facilitating fluid flow and enabling versatility in drain bag 202 placement. It will be clear to those of ordinary skill in the art having the benefit of this disclosure that the diameters, lengths, and dimensional differences described herein are illustrative and are not intended to be limiting.
In one embodiment, the different sections have different lengths. Experimental testing has shown that an overall drain tubing length of between about 1060 and about 1400 millimeters works well in Foley catheter applications. Accordingly, in one embodiment the first elongated section has a length of between about 1000 and 1300 millimeters. In one illustrative embodiment, the first elongated section 205 has a length of about 1170 millimeters. (The term “about” is used to include manufacturing tolerances and other variations that may occur in dimension.) In one embodiment, the helical section 206 and second elongated section 207 combine to have a length of between about 60 and 100 millimeters, and in one embodiment have a length of about 80 millimeters.
The drain bag 202 can take a variety of forms. In one embodiment, the drain bag 202 is a standard drain bag suitable for use in conventional Foley catheter applications. In another embodiment, the drain bag 202 is configured with a slightly smaller capacity than is found in traditional systems. For example, in the illustrative embodiment of
In one embodiment, the drain bag 202 includes a valve 212. The valve can be used by medical personnel for both emptying the drain bag 202 and for taking samples from the drain bag 202. In one embodiment, the valve 212 is configured as a “slide tap.” The operation of the slide tap will be explained in more detail with reference to
In one embodiment, the catheter connector 203 includes a sampling port 213. A health care services provider can take samples from the sampling port 213 by capturing fluid before it mixes with fluid in the drain bag 202. In one embodiment, the sampling port 213 is configured with a locking device, such as a Luer fitting, such that Luer-type and other syringes can be locked to the sampling port 213 when sampling is desired. In one or more embodiments, a protective cap 214 may be included with the catheter connector 203 to protect the catheter connector 203 during transit. The protective cap 214 can also help to keep the catheter connector 203 sterile prior to use. The catheter connector 203, protective cap 214, or sampling port 213 can each be manufactured from polyvinyl chloride, although other materials can also be used.
A hanger 215 can be included with the catheter assembly 200. The hanger 215 can be used, for example, to attach the drain bag 202 to a patient retention device such as a bed, chair, or wheelchair, or a patient assistance device such as a walker. The hanger 215 may be equipped with integrated clips 216 for this purpose. In some embodiments, secondary coupling devices 217 may be included as well. In the illustrative embodiment of
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In one embodiment, the hanger 215 is equipped with mechanical features that help to keep the coiled section (206) of the drain tubing (201) constantly aligned with respect to the coil. In many cases, this constant alignment will be substantially vertical when the hanger 215 is coupled to a drain bag (202). For example, when the bag connection device 301 is coupled to a drain bag, and the integrated clips 216 are attached to another object, the weight of the drain bag (202) will cause the bag connection device 301 to hang beneath the integrated clips 216. The mechanical features shown in
In the illustrative embodiment of
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In one embodiment, the helical section 206 has a unique geometric configuration that further helps to maintain an optimal “fluid draining” orientation as well. This geometric configuration can be seen in
The geometric alignment of the helical section 206 in
The axial entry is most easily seen in
The tangential exit is most readily seen in
Turning now to
The illustrative drain bag 802 of
Safety information 883 can optionally be included as well. For example, in the illustrative embodiment of
As noted above, in one embodiment a catheter assembly can be configured with a valve (212) suitable for draining the drain bag 802. As also noted above, in one embodiment the valve (212) is configured as a color-coded slide tap. Where this is the case, valve placards 890,891 can be added to the drain bag 802 to explain and/or illustrate the color-coded system.
Turning now to
Turning now to
As shown to the left of the placard 891, when the slide 901 is pushed into the body 902, a distal end 1001 becomes exposed. To further provide a visible indication of the status of the valve 212, the distal end 1001 can be color-coded. In this case, the distal end 1001 of the slide 901 is red. When the distal end 1001 is pushed out of the body 902, a healthcare provider can see “red.” As indicated on the placard 891, this means the valve 212 is closed. This color-coding system helps to prevent fluid spillage.
Turning now to
In contrast to
In the foregoing specification, specific embodiments of the present invention have been described. However, one of ordinary skill in the art appreciates that various modifications and changes can be made without departing from the scope of the present invention as set forth in the claims below. Thus, while preferred embodiments of the invention have been illustrated and described, it is clear that the invention is not so limited. Numerous modifications, changes, variations, substitutions, and equivalents will occur to those skilled in the art without departing from the spirit and scope of the present invention as defined by the following claims. Accordingly, the specification and figures are to be regarded in an illustrative rather than a restrictive sense, and all such modifications are intended to be included within the scope of present invention. The benefits, advantages, solutions to problems, and any element(s) that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, required, or essential features or elements of any or all the claims.
