Abstract:
The present invention provides for a disposable devices and kits to prevent the backflow of urine and other biofluids from a catheter bag and tubing into a patients bladder and further provides for the appropriate management of a catheter bag and tubing during the transport of a patient, while reducing the risk of a urinary tract infection (UTI) and maintenance of dignity. The advantages of the present invention make use of an inventive tubing retainer that is employed for catheter tube management. The tubing retainer may alternatively be included in a kit used for the management and transport of a catheter bag and flexible tubing which further includes a clip and a strap used to connect between the clip and the catheter and alternatively providing support of the catheter tube at the catheter inlet. Methods to use the tubing retainer and kits are further described.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application claims priority of U.S. Provisional patent application No. 62/099,434 filed Jan. 2, 2015, the contents of which are herein incorporated by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to medical devices, and more particularly, to a catheter and catheter tubing management kit and its method of use. 
       BACKGROUND OF THE INVENTION 
       [0003]    Urinary tract infections (UTI) are becoming a regular occurrence in the medical setting. Whether in hospitals, urgent care centers, outpatient centers, primary care providers, and even in retirement homes and hospice facilities, typically any patient who receives a catheter encounters a high risk of receiving a UTI. Once a catheter is placed, the daily incidence of a UTI is 3-10%. 10% to 30% of patients who undergo short-term catheterization (i.e. 2-4 days) develop an UTI. Between 90% and 100% of patients who undergo long-term catheterization develop UTI. Although UTI&#39;s are relatively easy to treat, they increase patient discomfort and almost universally require antibiotic drug therapy. These additional treatments and procedures ultimately lead to unnecessary costs in an industry where increased costs are being widely scrutinized. 
         [0004]    UTI&#39;s occur in medical settings for many reasons. Risk factors for a UTI in patients who are catheterized include: patient&#39;s lack of hygiene, improper sterility of catheter tubing during extended catheterization, longer duration of catheterization, lack of proper drainage and subsequent urine backflow, excessive manipulation of the catheter, catheter tubing, and its attendant drainage bag during patient transport, colonization of the drainage bag, diarrhea, diabetes, absence of antibiotics, female gender, renal insufficiency, errors in catheter care, catheterization late in the hospital course, and immunocompromised or debilitated states. 
         [0005]    Without being bound by any particular theory, it is believed that a common cause of UTI in the medical setting is the failure to have proper tubing and drainage bag placement, thus urine and other biofluids in the catheter tubing make their way back to the bladder, thus causing infection. Current solutions are to simply advise medical staff to ensure proper drainage by keeping the tubing and drainage bag at an elevation below the patient&#39;s bladder while the tubing remains above the drainage bag. Currently these are only “best practices” and no device or kit has been offered to ensure adherence to these “best practices”. 
         [0006]    In any event, and despite the “best practices”, transportation of a patient presents a challenge at ensuring these “best practices” can remain employed for a patient. Not only is it difficult to maintain the proper relative elevations of the bag and tubing, but the tubing and bag also increase the chances of tangle and snagging on other items while in transport which could cause movement of the catheter, increasing the likelihood of infection. Moreover, a patient is usually required to carry or place the drainage bag on their lap, or to dangle the bag and tubing from a chair or rollable tracks or carriers which is typically unsightly and embarrassing for the patient. Finally, the few solutions provided to address any concerns with catheters are typically very costly and not disposable, thus are rarely used due to the extra costs associated with recycling and sterilizing the accessories. 
         [0007]    No kit or device has been offered to date to account for any of these shortcomings, thus there remains an unmet need for a disposable device or kit to assist in preventing the backflow of urine and other biofluids from a catheter bag and tubing in to a patients bladder. There also remains an unmet need in a kit or device for the management of a catheter bag and tubing while transporting a patient, wherever the patient may be required to go, such as MRI/CT scan platforms or rehab. Finally, there remains an unmet need in transporting a patient and his catheter while reducing the risk of a UTI, while allowing the patient to keep their dignity in the transportation of their catheter. 
       SUMMARY OF INVENTION 
       [0008]    The present invention provides for a disposable devices and kits to prevent the backflow of urine and other biofluids from a catheter bag and tubing into a patients bladder and further provides for the appropriate management of a catheter bag and tubing during the transport of a patient, while reducing the risk of a urinary tract infection (UTI) and maintenance of dignity. 
         [0009]    The present invention first includes a tubing retainer having a bracket with two sections defined as a tube management section and a retainer storing section. The tubing management section and retainer storing section each have at least one hole or partial circle forming a c-shape for holding a tube, but in some embodiments may have a plurality of holes of partial circles. 
         [0010]    The disposable kits of the present invention provide for the management and transport of a catheter bag and flexible tubing, and include the inventive tubing retainer, at least one strap having two ends, a first end and a second end, and at least one clip wherein said at least one clip is connected to the first end of the at least one strap. The strap may include a plurality of independent or composite straps that include a long strap and a short strap having two ends, a first end and a second end, with the long strap being used to connect between at least one clip and the catheter, while the short strap may be used for tubing management or tubing management or support at the catheter inlet. 
         [0011]    Finally, the present invention provides methods employed using the inventive tubing retainer and kits for the management of a catheter system attached to a patient having a catheter and catheter tube. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]      FIGS. 1A-1C  illustrates a  102  strap clip which assists in the management of a catheter bag and tubing.  FIG. 1A  provides a side profile view illustrating the  102  strap clip having a  201  distal end and a  202  proximal end with a  204  slight bend at a distance from the  201  distal end and a  203  major bend at some distance between said  204  slight bend and said  202  proximal end.  FIG. 1B  illustrates a perspective view of the  102  strap clip illustrating a  205  strap eyelet at a distance between said  201  distal end and said  204  slight bend.  FIG. 1C  provides a front view illustrating the  102  strap clip. 
           [0013]      FIGS. 2A-2B  illustrates a  101  tubing retainer for holding coiled flexible catheter tubing.  FIG. 2A  provides a top view of the  101  tubing retainer illustrating the  301  tubing management section and the  302  retainer storing section each having at least one  303  hole.  FIG. 2B  provides a flat side view of the  101  tubing retainer illustrating the orientation of the  303  holes. 
           [0014]      FIGS. 3A-3C  illustrate the  100  catheter support kit and its use.  FIG. 3A  introduces the  103  strap which in some embodiments has one or more  304  adhesive pads.  FIG. 3B  illustrates the constituents of the  100  catheter support kit which includes the  101  tubing retainer, the  102  strap clip and the  103  strap.  FIG. 3C  illustrates the use of the  100  catheter support kit on a catheter showing the  101  tubing retainer coiling the  402  catheter tubing to provide a trap or dependent loop, while showing the  103  strap connected between the  401  catheter and the  102  strap clip. 
           [0015]      FIG. 4  illustrates the  101  tubing retainer coiling the  402  catheter tubing to provide a trap or dependent loop. 
           [0016]      FIGS. 5A-5C  show uses of the inventive  100  catheter support kit.  FIG. 5A  illustrates the  100  kit in use (as shown in  FIG. 3C ) with the  102  strap clip hanging from the back of a wheel chair.  FIG. 5B  illustrates the  100  kit in use (as shown in  FIG. 3C ) with the  102  strap clip hanging from the belt of an individual.  FIG. 5C  illustrates the  100  kit in use (as shown in  FIG. 3C ) being attached to the side rails of a hospital bed. Additionally,  FIG. 5C  illustrates that the  103  strap may be used to form a loop around the bed rail in the event that the  102  strap clip cannot accommodate the size of an object to be hung from. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0017]    The following detailed description is merely exemplary in nature and is in no way intended to limit the scope of the invention, its application, or uses, which may vary. The invention is described with relation to the non-limiting definitions and terminology included herein. These definitions and terminology are not designed to function as a limitation on the scope or practice of the invention, but are presented for illustrative and descriptive purposes only. 
         [0018]    The present invention contains the features of the urinary catheter management system and methods of use as herein described. 
         [0019]    It is to be understood that in instances where a range of values are provided that the range is intended to encompass not only the end point values of the range but also intermediate values of the range as explicitly being included within the range and varying by the last significant figure of the range. By way of example, a recited range of from 1 to 4 is intended to include 1-2, 1-3, 2-4, 3-4, and 1-4 
       Tubing Retainer 
       [0020]    A  101  tubing retainer for holding coiled flexible catheter tubing is provided which includes a bracket having two sections, a  301  tube management section and a  302  retainer storing section. The  301  tubing management section and the  302  retainer storing section each have at least one  303  hole for holding a tube. The  301  tubing management section is intended for holding in place coiled tubes for proper urine flow, while the  302  retainer storing section is used for optionally holding a section of catheter tube when the tubing management section is in use or is not in use. Without being bound by any particular theory, the  101  tubing retainer is intended to assist in creating a continuous flow for the urine and other biological fluids to the catheter bag, while creating a trap, or dependent loops, preventing the biological fluids from travelling back up the tubing even in the event that the recommended relative elevations of the catheter bag and tubing, in relation to the patients bladder, is not maintained or is disturbed as a result of transporting the patient. 
         [0021]    In at least one embodiment, the  303  at least one hole in the  301  tubing management section and the  302  retainer storing section is a partial circle forming a c-shape. In at least one embodiment the  303  c-shaped hole has two indents slightly protruding the diameter of the hole. In at least one embodiment, the  301  tubing management section has at least three  303  holes. 
         [0022]    It is appreciated that many suitable materials are known in the art for the construction of disposable medical devices, and nothing herein is intended to be limiting the  101  tubing retainer to any particular material. In at least one embodiment, the  101  tubing retainer is made from plastic, glass reinforced plastic, fiberglass, metal, wood, poly vinyl chloride (PVC), polycarbonate material, silicon, stainless steel, aluminum or combinations thereof. In at least one embodiment the materials selected is intended to be disposable, while structurally sound for providing the functionality described herein. In at least one embodiment the  101  tubing retainer is made from PVC or a polycarbonate material. 
       Strap Clip 
       [0023]    A  102  strap clip for suspending a catheter bag from an object is provided which includes a rectangular plate that forms a “U” shape clip having a  201  distal end and a  202  proximal end and is illustrated in  FIGS. 1A-1C . The  102  strap clip has at least one  205  strap eyelet for receiving one end of a strap. The other end of the strap is connected to a catheter bag. The  102  strap clip allows for the ease of transportation of a catheter bag by holding the bag in a position not likely to get tangled, and based on placement, will assist to ensure that the catheter bag will remain below the bladder of the patient. The  102  strap clip may be connected to the back or seat of a chair or wheelchair, or may be connected to the belt or belt loop of the patient, medical staff assistant, or any other person or object who may be assisting the patient. The  102  strap clip includes a  204  slight bend at a distance from the  201  distal end and a  203  major bend at some distance between said  204  slight bend and said  202  proximal end, thus the  102  strap clip generally forming a “U” shape. In at least one embodiment the  204  slight bend is at least a 15 degree bend. 
         [0024]    In at least one embodiment the  204  slight bend is at least a 45 degree bend. In at least one embodiment, the  204  slight bend is at least a 90 degree bend with the bend terminating where the direction of the  102  clip continues to travel away from the  201  distal end. It should be appreciated that two or more bends may be used to attain the  204  slight bend. In at least one embodiment the  203  major bend is at least 90 degrees. In at least one embodiment the  203  major bend is at least 180 degrees with the bend terminating where the direction of the  102  clip continues to travel back in the same direction as the  201  distal end. The  205  strap eyelet is located some distance between the  201  distal end and the  204  slight bend. 
         [0025]    It is appreciated that many suitable materials are known in the art for the construction of disposable medical devices, and nothing herein is intended to be limiting the  102  strap clip to any particular material. In at least one embodiment, the  102  strap clip is made from plastic, glass reinforced plastic, fiberglass, metal, wood, poly vinyl chloride (PVC), silicon, stainless steel, aluminum or combinations thereof. In at least one embodiment the materials selected is intended to be disposable, while structurally sound for providing the functionality described herein. In at least one embodiment the strap clip is made from PVC. 
       Kit 
       [0026]    A disposable kit for the management and transport of a catheter bag and flexible tubing, is provided which includes at least one  101  tubing retainer, at least one  102  strap clip and at least one  103  strap having a first end and a second end. The first end of the  103  strap is connected to the strap clip while the second end of the  103  strap is for the connection to a catheter bag. It is appreciated that the  103  strap may include one or more  304  adhesive tabs. The  304  adhesive tabs may be used to shorten the length of the  103  strap, or to form loops on the strap for connecting to a  102  strap clip or a catheter. In some embodiments the  304  strap may comprise of a combination of a short strap and a long strap as illustrated in  FIG. 3A . The short strap and long strap may come as two separate pieces, or may be part of one  304  strap. The long strap, where used alone or in combination with the short strap, is at least 6 inches in length having two ends, a first end and a second end. In at least one embodiment the short strap is at least 1 inch in length, and no greater than 6 inches in length having two ends, a first end and a second end. 
         [0027]    The strap allows or the connection of the catheter bag and tubing to many movable objects, including humans, thus allowing gravity to maintain the catheter bag and tubing below the proximate location of the patients bladder. In at least one embodiment the strap has an adjustable length between 6 inches and 3 feet. In at least one embodiment the strap has an adjustable length between 1 to 2 feet. It is appreciated that many suitable materials are known in the art for the construction of disposable medical devices and lanyards, and nothing herein is intended to be limiting the strap to any particular material. In at least one embodiment, the strap is made from nylon, rubber, hook and loop fasteners, glass fiber, burlap, Tyvek, cotton, polyester, or combinations thereof. In at least one embodiment the materials selected is intended to be disposable, while structurally sound for providing the functionality described herein. In at least one embodiment the strap is made from Tyvek. 
         [0028]    It is appreciated that many catheter bags have hooks for holding or storing the catheter bag pre-fabricated into their structure. In at least one embodiment the strap further comprises a loop at said second end for holding the hook of a catheter strap. 
         [0029]    In at least one embodiment the kit further includes a dignity bag, or a bag for holding and disguising a catheter bag. It is appreciated that many suitable materials are known in the art for the construction of disposable medical bags, and nothing herein is intended to be limiting the dignity bag to any particular material. In at least one embodiment, the dignity bag is made from nylon, rubber, glass fiber, plastic, silicon, burlap, Tyvek, cotton, polyester, or combinations thereof. 
         [0030]    Finally, the kit further includes printed instructions for attaching the first end of the strap to the  102  strap clip, the second end of the strap to the catheter bag, and instructions for coiling the catheter tubing and attaching the  101  tubing retainer to the coiled catheter tubing. It should be appreciated that the instructions provided are not required to be in any specific order, and the numbering of such printed instructions shall be read to require the performance of one step prior to the performance of any other step. It is further appreciated that the steps may be performed in any order with the goal of decreasing the amount of pain on the patient and/or facilitating the maintenance of the elevation of the catheter bag below the bladder of the patient. Uses of the kit in relation to different objects are illustrated in  FIGS. 5A-5C . 
         [0031]    The drawings and diagrams shown herein depict example arrangements of elements of the kit, its individual components and the methods described herein. More or less than all the features available or contemplated may be present in an actual embodiment. It should also be understood that  FIGS. 1A-1C, 2A-2B, 3A-3C, 4 , &amp;  5 A- 5 C are merely illustrative and may not be drawn to scale. 
       EXAMPLES 
       [0032]    It is to be understood that while the invention has been described in conjunction with the detailed description thereof, the foregoing description is intended to illustrate and not limit the scope of the invention, which is defined by the scope of the appended claims. Other aspects, advantages, and modifications are within the scope of the following claims. 
       Example 1 
       [0033]    A  100  kit for the management of a  401  catheter bag and  402  tubing is provided to assist in the transportation of a patient, with the kit as illustrated in  FIG. 3A  and  FIG. 3B . The kit includes a  101  tubing retainer, a  102  strap clip, and a  103  strap. The  101  tubing retainer has three  303  holes forming a c-shape on the  301  tubing management section and one  303  hole forming a c-shape on the  302  retainer storing section. The  101  tubing retainer is provided and illustrated in  FIGS. 2A-2B . The  102  strap clip has a  204  slight bend of approximately 90 degrees, and a  203  major bend of approximately 180 degrees. The  103  strap provided is a Tyvek strap of approximately 16 inches in length, having  304  adhesive at each end for securing the strap or forming loops for holding a catheter bag, as necessary. The  100  kit further includes printed instruction for attaching the  103  strap to the  102  strap clip, the  103  strap to the  401  catheter bag, and the  101  tubing retainer to the  402  catheter tubing. 
       Example 2 
       [0034]    The  100  kit from Example 1 is provided for the management of a catheter system attached to a patient. The catheter system includes a  401  catheter bag and  402  tubing. A nurse removes the contents of the  100  kit and proceeds to follow the written instructions. The nurse decides first where to attach the strap for the transport of the patient, which in this case the nurse intends to attach the strap to the waist of the nurse for tandem transit with the patient (see  FIG. 5B ). Next, the nurse connects the first end of the  103  strap to the  102  strap clip by sliding the  103  strap through the  205  strap eyelet, then exposing the  304  adhesive on the first end to form a loop and securing the  102  strap clip into the loop formed by the  103  strap. Next the nurse forms a loop at the second end of the  103  strap by exposing the  304  adhesive at the second end of the  103  strap and forming a loop for holding the hook of the  401  catheter bag. The nurse adjusts the strap length before securing the  304  adhesive such that the  401  bag and  402  tubing will remain below the patents bladder while transporting. The patient is moved from their gurney to a wheelchair. The nurse coils the  402  catheter tube and uses the  101  tubing retainer for retaining the coiled  402  catheter tubing. The nurse supports the  102  strap clip with their hand, while attaching the hook of the  401  catheter bag to the loop formed at the second end of the  103  strap. The  102  strap clip is alternatively attached to the patient&#39;s chair (see  FIG. 5A ), the patient (see  FIG. 5C ), or to some other movable object, provided that the catheter bag and tubing remain below the patient&#39;s bladder. 
         [0035]    After the transportation is complete, or upon the removal of the catheter of the patient, the medical staff handing the discarded  401  catheter bag disposes of the  101  tubing retainer, the  102  strap clip, and the  103  strap are discarded in the appropriate waste receptacle. 
       Other Embodiments 
       [0036]    While at least one exemplary embodiment has been presented in the foregoing detailed description, it should be appreciated that a vast number of variations exist. It should also be appreciated that the exemplary embodiment or exemplary embodiments are only examples, and are not intended to limit the scope, applicability, or configuration of the described embodiments in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient road map for implementing the exemplary embodiment or exemplary embodiments. It should be understood that various changes can be made in the function and arrangement of elements without departing from the scope as set forth in the appended claims and the legal equivalents thereof.