URINARY CATHETER WITH INTEGRATED COIL

Abstract

An indwelling catheter with an integrated coil section is disclosed. The coil section, in use, is disposed outside of the urethra and can stretch and bend to accommodate various activities of a user by reducing frictional forces and trauma within the urethra. This improved catheter design results in an increase in range of motion and a decrease in pain for the user.

Claims

1. An indwelling catheter comprising: an elongated catheter main body defining: a first section that is configured to be inserted into a urethra; a second section that comprises a plurality of ports and is configured to be disposed outside of the urethra; and a coil section that is disposed between the first section and the second section and is configured to be disposed outside of the urethra, wherein the coil section is configured to expand and bend based on external forces applied to the second section and the coil section.

2. The indwelling catheter of claim 1, wherein the coil section comprises between six and eight coiled tubes.

3. The indwelling catheter of claim 2, wherein the coil section comprises six coiled tubes.

4. The indwelling catheter of claim 2, wherein each of the plurality is a substantially circular loop in shape.

5. The indwelling catheter of claim 1, wherein the coil section comprises a plurality of coiled tubes.

6. The indwelling catheter of claim 1, wherein, in a contracted position, a longitudinal length of the coil section is approximately 2 to 2.25 inches.

7. The indwelling catheter of claim 6, wherein, in a stretched position, a longitudinal length of the coil section is approximately 4.25 inches.

8. The indwelling catheter of claim 1, wherein the coil section is configured to bend up to approximately 180 degrees.

9. The indwelling catheter of claim 1, further comprising a plurality of channels extending from the first section, through the coil section, and to the second section.

10. The indwelling catheter of claim 9, wherein each channel of the plurality of channels is operably associated with a respective port of the plurality of ports.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The following figures are included to illustrate certain aspects of the present disclosure and should not be viewed as exclusive embodiments. The subject matter disclosed is capable of considerable modifications, alterations, combinations, and equivalents in form and function, without departing from the scope of this disclosure.

[0018] FIG. 1 is a schematic view of an embodiment of the present invention, shown in use;

[0019] FIG. 2 is a perspective view of the embodiment of the present invention;

[0020] FIG. 3 is a detailed side view of the embodiment of the present invention, showing the coil in an unstretched, non-bent position;

[0021] FIG. 4 is a detailed side view of the embodiment of the present invention, showing the coil in a stretched position, with the unstretched position shown in phantom lines for reference;

[0022] FIG. 5 is a detailed side view of the embodiment of the present invention, showing the coil in a first bent position, with the unbent position shown in phantom lines for reference; and

[0023] FIG. 6 is a detailed side view of the embodiment of the present invention, showing the coil in a second bent position.

DETAILED DESCRIPTION OF THE INVENTION

[0024] The subject disclosure is described with reference to the drawings, wherein like reference numerals are used to refer to like elements throughout. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the present disclosure such that one skilled in the art will be enabled to make and use the present invention. It may be evident, however, that the present disclosure may be practiced without some of these specific details.

[0025] Broadly, one embodiment of the present invention is an indwelling catheter with an integrated coil section disposed on an outer side thereof (i.e., the side that does not extend into a user's urethra). Referring to FIGS. 1-6, a catheter 10 is provided substantially in the form of a traditional indwelling urinary catheter in terms of components and functionality. For example, the catheter may include one or more drain ports 14 and an inflator port 1 for filling a balloon 24 (which holds the catheter 10 in position, once inserted into a bladder 20 of a user 18). Insertion is typically done by a medical professional, homecare nurse, or individual under guidelines and directive from a professional specializing in incontinence. This catheter 10 drains urine from the bladder 20 into a bag (not shown) outside the body of the user 18. The catheter 10 has three primary sections, a first section that extends into the urethra and terminates in the bladder 20 of the user, a second section that includes the aforementioned ports 14, 16, and a coil section 12 disposed therebetween.

[0026] Advantageously, the coil section 12 is incorporated with the catheter 10 in order to increase its range of motion and, in general, flexibility. The coil may comprise six to eight coiled tubes (and preferably, for proper operation, six coils), approximately 2-2.25 inches in length (in a relaxed/contracted state), added proximal the one or more drain ports 14 and the inflator port 16. The coil section 12, embodied in a manner as described above, offers an unbridled range of motion up to 4.25 inches due to the expansion and retraction. An additional 2-2.25 inches is also added to the overall length of the catheter 10 to compensate for the added coil section 12, allowing for penis erections without obstruction.

[0027] With the new advanced coiled design (i.e., the coil section 12) coupled with the traditional features of the indwelling catheter 12, design and performance are improved ten-fold. Embodiments of the present invention now permit a significantly wider range of motion by reducing back and forth friction of the part of the catheter that is inside the urethra that causes restriction of movement. The concept is similar to a suspension on an automobile that absorbs the bumps on a road while the car remains stabilized.

[0028] In use, and as shown in FIGS. 3 and 4, the coil section 12 can selectively expand and collapse, based on external forces, just above the urine drainage 14 and balloon 16 port and before the external urethral opening to the traditional/Foley indwelling catheter design (i.e., the section 12 is, in use, just outside the body of the user 18, as shown in FIG. 1). The internal part of the catheter 10 that is in the urethra/urinary tract is 12 to 14 inches and remains stable due to the coil section 12, thereby minimizing friction causing pain. The kinetic energy, created by a range of motion or ROM from walking, running, biking, etc., is absorbed by the expansion and contraction of the coil section 12, thereby reducing friction (the resistance that one surface or object encounters when moving over another) of the catheter's indwelling portion in the urethra, which is what causes pain. Similarly, as shown in FIGS. 5-6, the coil section 12 permits the catheter 10 to bend approximately 180 degrees in all directions, even further increasing the absorption of external forces on the catheter (and therefore, reducing the stress applied to the indwelling portion of the catheter 10 in the urethra). Residually, this will help to reduce a user's otherwise sedentary lifestyle (borne out of necessity due to discomfort). A major advantage of this embodiment is the simplicity of design. For example, there are no other complicated biasing mechanisms or other structure that would make it more difficult to use, more uncomfortable to use or more likely to break after prolonged usage, not to mention increases costs associated with the production thereof (due to the higher level of complexity of design).

[0029] The indwelling catheter 10 with integrated coil section 12 of the present invention may be formed from various appropriate materials, including rubber, latex, silicone, or a combination thereof. In certain embodiments, a combination of soft plastic polymers may be molded to create the external shell and internal tubing of the catheter 10. A rigid plastic polymer may be molded as a cap and fit to the balloon port 16. The soft plastic polymers are procured/formed to create the flexible catheter tube 10, along with the coil section 12. The inner portion of the catheter 10 contains two internal channels, extending through the coil section 12, and ending in two ports 14, 16. The first internal channel leads to the port 14 to drain urine from the bladder. The second internal channel leads to the balloon port 16 used to inflate and deflate the balloon 24 of the catheter that keeps it secure inside the bladder 20. The hard-plastic polymers are procured/formed to create a cap that houses an inflation device and may be molded to the balloon port 16. Any appropriate molding apparatus may be used to produce embodiments described herein.

[0030] ADL (Activities of Daily Living) studies measure the joint angles involved in everyday tasks of everyday living. This is especially important for males 50 plus. Basic ADL's include eating, dressing, getting in or out of bed or a chair, taking a shower or bath and using the toilet. ROM (Range of Motion) Functional joint range of motion has been defined as the minimum range of motion (ROM) necessary to perform activities of daily living comfortably and effectively. Using geometry plus the following averages: the male height of 5′9″, a leg inseam of 31″, length of stride required, divided by 2 (male urinary tract is centered) equals the measurement needed to perform individual activities, the following working coil measurements were calculated to provide adequate range of motion (ROM) for different activities. [0031] 1. Standing: typical leg separation angle: 15°; coil retracted length: 2.25 inches [0032] 2. Basic ADL (as explained above): typical leg separation angle: 30°; coil working length: 2.75 inches [0033] 3. Running, tennis, basketball, swimming, and the like: typical leg separation angle: 45°; coil working length: 3.25 inches [0034] 4. Bicycling and hiking: typical leg separation angle: 90°; coil working length: 4.25 inches

[0035] The application of the coil system 12 of the present invention is the best possible way to allow a range of movement and maintain the integrity and functionality of the existing indwelling catheter. The internal tube structure of a catheter 10 has two channels, sometimes three, that must be adhered to. The large channel is to void urine, the second, smaller channel is to inflate and deflate the balloon for the catheter to remain secure, and when included, a third channel is used for irrigation and flushing of the bladder. In research and development of the present invention, it was determined that any design other than tubular coils 12 would destroy the utility of an indwelling catheter 10.

[0036] In conclusion, BPH is anticipated to be the fastest-growing segment with a CAGR of 5.80% It is a very common condition in the aging population. According to the Urology Care Foundation, around half of the men in the age of 51 and 60 years have BPH and up to 90% of the men in the age of 80 years have BPH. Acute urinary retention is a serious complication associated with BPH and requires catheterization of the bladder. The National Association for Continence states that it affects approximately 200 million people worldwide. It also states that one-third of the men and women between the age of 30 and 70 years face a loss of bladder control at some point in their adult life. An indwelling catheter 10 with integrated coil section 12, in accordance with the present invention, will offer a solution to that astonishing number by allowing quality of life for the duration of catheter use.

[0037] While one or more preferred embodiments are disclosed, many other implementations will occur to one of ordinary skill in the art and are all within the scope of the invention. Each of the various embodiments described above may be combined with other described embodiments in order to provide multiple features. Furthermore, while the foregoing describes a number of separate embodiments of the apparatus and method of the present invention, what has been described herein is merely illustrative of the application of the principles of the present invention. Other arrangements, methods, modifications, and substitutions by one of ordinary skill in the art are therefore also considered to be within the scope of the present invention, which is not to be limited except by the claims that follow.

[0038] While apparatuses and methods are described in terms of “comprising,” “containing,” or “including” various components or steps, the apparatuses and methods can also “consist essentially of” or “consist of” the various components and steps. All numbers and ranges disclosed above may vary by some amount. Whenever a numerical range with a lower limit and an upper limit is disclosed, any number and any included range falling within the range is specifically disclosed. In particular, every range of values (of the form, “from about a to about b,” or, equivalently, “from approximately a to b,” or, equivalently, “from approximately a-b”) disclosed herein is to be understood to set forth every number and range encompassed within the broader range of values.

[0039] Also, the terms in the claims have their plain, ordinary meaning unless otherwise explicitly and clearly defined by the patentee. Moreover, the indefinite articles “a” or “an,” as used in the claims, are defined herein to mean one or more than one of the elements that it introduces. If there is any conflict in the usages of a word or term in this specification and one or more patent or other documents that may be incorporated herein by reference, the definitions that are consistent with this specification should be adopted. Moreover, the use of directional terms such as above, below, upper, lower, upward, downward, left, right, and the like are used in relation to the illustrative embodiments as they are depicted in the figures, the upward or upper direction being toward the top of the corresponding figure and the downward or lower direction being toward the bottom of the corresponding figure.

[0040] As used herein, the phrase “at least one of” preceding a series of items, with the terms “and” or “or” to separate any of the items, modifies the list as a whole, rather than each member of the list (i.e., each item). The phrase “at least one of” allows a meaning that includes at least one of any one of the items, and/or at least one of any combination of the items, and/or at least one of each of the items. By way of example, the phrases “at least one of A, B, and C” or “at least one of A, B, or C” each refer to only A, only B, or only C; any combination of A, B, and C; and/or at least one of each of A, B, and C.