WO2005104776A2

WO2005104776A2 - Apparatus for stabilizing a tube

Info

Publication number: WO2005104776A2
Application number: PCT/US2005/014572
Authority: WO
Inventors: Edward Walsh; Vicki Johnson
Original assignee: The Uab Research Foundation
Priority date: 2004-04-27
Filing date: 2005-04-27
Publication date: 2005-11-10
Also published as: WO2005104776A3

Abstract

Provided herein is a retaining device for securing tubing. In one use, the retaining device comprises a base and a securing member and is used to secure medical tubing to a patient in order to prevent trauma to the patient or inadvertent tube removal. The retaining device may further comprise a medical adhesive allowing the retaining device to be secured to the patient at any desired location. The retaining device may also be supplied in the form of an array comprising a plurality of securing members allowing the user to use any desired configuration for securing medical tubing.

Description

APPARATUS FOR STABILIZING A TUBE Inventors: Vicki Johnson and Edward Walsh

FIELD OF THE DISCLOSURE The present disclosure relates generally to the field of devices for holding and securing articles. In one embodiment, the present disclosure relates to devices for holding and securing medical articles.

BACKGROUND Due to a wide variety of medical procedures, patients may have tubes placed on their person for the administration of either temporary or permanent therapy. Examples of tubes for temporary therapy include, but are not limited to, nasogastric tubing for suction and/or feeding, indwelling urethral catheters, intravenous tubing, chest tubes, and various tubes for drainage. Examples of tubes for permanent therapy include, but are not limited to, percutaneous endogastrostomy tubes, indwelling Foley catheters, a suprapublic indwelling catheter and oxygen tubing. All of these tubes, regardless of therapeutic intent, can be cumbersome to the patient with respect to ambulation, activities of daily living (ADLs), and comfort. In addition to interference with ambulation, ADLs and comfort, unsecured tubing can present a hazard in the case of unintentional removal and/or displacement (referred to herein as a "displacement event"), as well as being a contributing factor to falls due to tubing becoming tangled around the patient's feet, or nearby objects. Consequences of inadvertent tube removal include, but are not limited to, infection, bleeding, and costly procedures for replacement. Healthcare providers presently use a variety of methods to secure medical tubing to a patient. Adhesive tape is commonly used for this purpose. However, adhesive tape has a number of disadvantages. First of all adhesive tape is only effective to secure tubing and similar devices for short period of time. Furthermore, most adhesive tapes are not waterproof, meaning the tubing is not secured when the patient is exposed to moisture (such as may be the case when bathing or when the adhesive is exposed to perspiration). Finally, in many cases it is required that the adhesive tape be removed to reposition or replace the medical tubing. Adhesive tapes often remove a layer of the skin during such processes and may create an abraded area or a wound. This may cause patient discomfort and may be a source of infection. More importantly, adhesive tape may not secure the medical tubing in place even though the adhesive tape remains bonded to the skin. Such a situation may occur as a result of movement of the patient and/or the tubing such that the adhesive tape fails to secure the tubing. As a result, the forces applied to the patient and or the tubing are transmitted via the tubing to the insertion site for the tubing. This can result in irritation to the insertion site and/or cause a displacement event, with ramifications as discussed above.

BRIEF DESCRIPTION OF THE DRAWINGS So that the features, advantages and objects of the devices disclosed herein, as well as others that will become clear, are attained and can be understood in detail, more particular descriptions of certain embodiments of the devices disclosed are illustrated in the appended drawings. It is to be noted, however, that the appended drawings illustrate certain embodiments of the invention and therefore are not to be considered limiting in their scope.

FIG. 1A is a perspective view of one embodiment of a retaining device as described herein comprising a two securing members.

FIG. IB is a perspective view of one embodiment of a single securing member.

FIG. 2A is a perspective view of an alternate embodiment of the retaining device in the form of an array comprising a plurality of securing members.

FIG. 2B shows one embodiment of a custom designed retaining device having a configuration of securing members derived from the array of FIG. 2A as used on a patient to secure a feeding tube. FIG. 3A is a perspective view of an alternate embodiment of a custom designed retaining device having a configuration of securing members derived from the array of FIG. 2A as used on a patient to secure a feeding tube and further comprising a motion restraint. FIG. 3B is a frontal view of one embodiment of the motion restraint.

DETAILED DESCRIPTION The present disclosure describes a disposable retaining device for use in securing tubing to a patient's body. As used herein, "tubing" is meant to include any device or apparatus with a hollow interior, having either a circular or non-circular cross section, that functions as a passage. The tube may be used to transport a variety of solutions, including, but not limited to, liquids, gels, suspensions, emulsions and the like; a solution may comprise a solid component. In one embodiment, the tubing may be medical tubing. Exemplary types of medical tubing include, but not limited to, nasogastric tubing for suction and/or feeding, indwelling urethral catheters, intravenous tubing, chest tubes, various tubes for drainage, percutaneous endogastrostomy tubes, indwelling Foley catheters, a suprapublic indwelling catheter and oxygen tubing. However, any medical tubing, whether now in use or used in the future, may be used with the retaining device disclosed. The retaining device can be designed for use with tubing of various sizes and cross sections, rendering it suitable for use in multiple applications including, but not limited to, feeding and intravenous tubing. The retaining device may be used alone or in combinations and/or modular configurations as described in more detail herein, with the advantages inherent in such modular configurations being also described herein. As a result, the retaining device described can be used to secure tubing of a variety of lengths, sizes and cross sections. The retaining device can be used in the in-home care setting, in nursing homes, and in hospital settings. The modular placement of the retaining devices in a number of locations as desired allows for securing of any lengths of tubing in any desired configuration. In addition, since certain tube materials can stiffen with prolonged positioning in a single configuration, the ability to reconfigure the tube path will prolong the life of the tube, resulting in less frequent tube replacement procedures. Furthermore, using the retaining devices as described herein provides for tubing stabilization as well as restraining of the entire length of the tube to further prevent interaction between the tube and nearby objects that can cause a dislocation event. FIG. 1A shows one embodiment of a retaining device as disclosed. The basic structure described for the retaining device is also applicable to the retaining devices described in modular configurations. The retaining device 1 comprises a base portion 10, which further comprises an upper side 14 and a lower side 12. The lower side 12 may further comprise a medical adhesive 15 as described below and a removable cover 13 for the medical adhesive (not shown). The base portion 10 may be manufactured from a variety of materials. In one embodiment, the base is manufactured from a plastic or a rubber material. Suitable plastics and rubbers include, but are not limited to, materials such as silicone, fluorosilicone, latex rubber, polyvinylchloride, polycarbonate, polypropylene, polyurethane, acetal resin, cflex resin, polyethylene terephthalate, thermoplastic elastomers, nylon, polysulfone, polyaryletherketone, polyesters, etc. In one embodiment, the plastic selected exhibits chemical resistance to solvents and is also non- allergenic. In order to maximize patient comfort, the plastic or rubber material selected may be soft and flexible. In one embodiment, the base is manufactured from a semi-permeable polyurethane film comprising an adhesive colloidal material. An exemplary commercially available product is marketed under the brand name DuoDERM™ (Convatec) and comprises a flexible polyurethane foam layer with a hydrocolloid adhesive composition. The adhesive colloidal material may be waterproof, allowing the patient to bathe with the retaining devices in position without changing. This minimizes the cost of application as well as any irritation that may develop after prolonged use. In one embodiment, the colloidal material does not contain chemicals or compounds such as latex that may induce an allergic reaction in the patient. The base 10 may further comprise a protective cover 40 placed over the base 10. The protective cover may aid in the stabilization of the retaining devices. The protective cover 40 may be manufactured from the materials described above. In one embodiment, the protective cover 40 is manufactured from the same material as the base 10. The upper side 14 of base 10 further comprises at least one securing member 16 mounted on upper side 14. The at least one securing member 16 may extend into the base 10 or may be secured to the upper side 14 of base 10 (such as by protective cover 40). The securing member 16 comprises a central portion 18 (as shown in FIG. IB). Extending upwardly from and in communication with central portion 18 are a plurality of arm members, illustrated in this example as arm members 20A and 20B. The arm members 20A and 20B each have a curved surface 22, a distal end 24 and a proximal end 26. The proximal ends 26 are in communication with opposite sides of the central portion 18. The curved surfaces 22 of the arm members 20A and 20B form a channel 28 with a diameter Z to receive a tubing 30, (not shown in FIGS 1A and B), which in one embodiment is medical tubing. The diameter Z is selected based on the diameter of the tubing to be secured. The diameter Z is such that the arm members 20A and 20B provide sufficient pressure to secure tubing 30 in place without constricting the flow of solution through tube 30. The diameter Z can be increased or decreased by altering the width B of central portion 18 and/or by altering the curvature of the curved surfaces 22 in the arm members 20A and 20B. In one embodiment, the securing member 16 may be manufactured as a one piece unit. In an alternate embodiment, the securing member 16 may be manufactured in more than one piece and assembled to form the finished unit. In one embodiment, arm members 20A and 20B may comprise a gripping element 32 along at least a portion of their length to help secure the tubing 30 in place. In one embodiment, the gripping element 32 may be a ridge or a protrusion extending away from the curved surface of said arm members in the direction of the channel 28 (See FIG. IB). In an alternate embodiment, at least a portion of the interior portions of the arm members 20A and/or 20B may comprise a non-skid surface, said non-skid surface comprising the gripping element 32. In yet a further embodiment, at least a portion of the interior portions of the arm members 20A and or 20B may comprise an adhesive, said adhesive comprising the gripping element 32. The arm members may further comprise a pinch portion 34. The pinch portion 34 is in communication with the distal end 24 of each of the arm members 20A and B. The function of the sloping segments 34 is to allow the securing member to be opened easily to allow the insertion of the tubing 30. The base 10 may be manufactured so as to have a variety of colors or design configurations. The different color or design configurations on the base 10 may create a more aesthetically pleasing appearance to the retaining device 1. This may be especially desirable feature when young children are the patients utilizing the retaining device 1. In one embodiment, the design configurations are animals, a logo (a logo may be any recognizable figure representing a group or entity, such as, but not limited to, a professional sports team, a performing group or a corporatio) theme characters, such as cartoon characters, fairy tale characters and the like, landscape scenes, various patterns (such as geometric patterns) and similar designs as is known in the art. In an alternate embodiment, the base 10 may comprise one or more colors in various patterns. In still yet another embodiment, the colors and design configurations may be combined. The arm members 20A and 20B may also be constructed from a variety of materials. In one embodiment, the arm members are manufactured from a flexible plastic. The use of a flexible plastic allows repeated tube removal and reattachment. The retaining device 1 may comprise one securing member 16 or a plurality of securing members 16. In one embodiment, a plurality of the securing members 16 are placed on the base 10 in the form of a pre-fabricated array 100 (shown in FIG. 2A). The base 10 of the array 100 is constructed as described above and has an upper side 14 and a lower side 12, with the lower side 12 further comprising a medical adhesive 15 and removable cover 13 (as described below). The upper side 14 comprises a plurality of securing members (all indicated by the reference numeral 16) secured thereto. The securing members 16 may extend into the base 12 or may be secured to the upper side 14 of base 12 as described above. The securing members 16 may have the structure described above and as shown in FIG. IB. In one embodiment, the plurality of securing members 16 is arranged in a pre-determined pattern. The spacing of the securing members 16 on the array 100 is not critical to the present invention and can be varied as desired by varying the distances X and Y in FIG. 2A. In the embodiment illustrated in FIG. 2A, X is 1 inch and Y is 1 inch. In this embodiment, each X and Y is the same between each securing member 16 (referred to as an ordered array). In an alternate embodiment, one or both of the X and Y distances are different at least two of the individual securing members 16 (referred to as a non-ordered array). The securing members 16 are attached to the base 10 over a sufficiently large area to prevent the weight of the tube 30 and/or applied force to the tube 30 from dislocating the retaining device 1 from the skin. The number of securing members 16 in each array 100 can be varied by increasing or decreasing the dimensions of the base 10 containing the array 100 or by changing the values of X and/or Y for a base 10 of a given dimension. In FIG. 2 A, the array 100 as shown as a 7 x 9 array, with both X and Y being 1 inch apart. Furthermore, the orientation of the securing members 16 in relation to one another in the array 100 may be uniform or may be non-uniform. In the embodiment shown in FIG. 2A the orientation of the securing members is generally uniform, meaning the orientation of each securing member 16 is the same with respect to one another. However, it should be considered within the scope of the disclosure to provide one or more securing members 16 so that they are in a different orientation with at least one other securing member 16 in the array (see lower left and right hand corners of array 100 in FIG. 2A). Such non-uniform placement may be useful when a user desires to create a custom configuration that requires a change in direction of the tubing (such as an L-shape). The uniform and non-uniform placement of the retaining devices 16 can be used with an ordered array or a non-ordered array. The retaining device 1 may be used in a variety of combinations. Various custom configurations of the retaining device 1 may be constructed from the array 100 shown in FIG. 2A. These custom configurations may contain multiple securing members 16 or may comprise a single securing member. Additionally, a plurality of custom configurations of the retaining device 1 may be used in conjunction with one another when desired. The various custom configurations of the retaining device 1 may be used as desired to provide optimal securing of the desired tubing. Using such custom configurations of the retaining device 1, a user can create a number of custom arrangements of securing members 16 for use in a specific application. Therefore, the retaining device 1 can be custom tailored to provide for securing medical tubes for any needed application. As shown in FIG. 2A, a portion of the array 100 of retaining device 1 has been outlined. A user may cut the array 100 so as to prepare a custom arrangement of securing members 16 on the retaining device 1. After peeling away the cover from the lower side 12 to expose the medical adhesive 15, the desired, custom arrangement of securing members (indicated as 100A and 100B) is adhered to the skin of the patient 150 in the desired locations as shown in FIG. 2B. In this embodiment, the securing members 16 of the retaining device 1 are used to secure a percutaneous endogastric feeding tube (designated 30) both near the site of insertion 152 and near the filling end 154 to stabilize the tubing in order to prevent inadvertent removal or partial removal of the tube 30. Additionally, the configuration secures the tube against the patient to permit normal wearing of clothing. FIG. 3 A shows an alternate embodiment of the retaining device 1. In this embodiment, the securing members 16 of the retaining device 1 are used to secure a percutaneous endogastric feeding tube (designated 30) both near the site of insertion 152 and near the filling end 154 to stabilize the tubing as described in FIG. 2B. In this embodiment, the retaining device 1 further comprises a motion restraint 50. The motion restraint 50 serves to reversibly engage the tubing 30 secured by the securing members 16 and is placed on the portion of tubing 30 between two of said securing members 16. In use, the motion restraint 50 serves to prevent the unwanted movement of the tubing 30 by limiting the motion of tubing 30. If the tubing 30 is pulled in the left or right direction, then the motion restrain 50 will impact one of the securing members 16. In both cases, the motion of tubing 30 is limited by the motion restrain 50, further preventing the tubing 30 from becoming dislocated. In one embodiment, the motion restraint 50 comprises an outer member 52, said outer members comprising a slit 54 along its long axis to allow its placement over and reversible engagement of the tubing (FIG. 3B). The diameter of the outer member 52 may be selected based on the diameter of the tubing. The motion restraint 50 engages the tubing snugly to prevent movement of the tubing along the long axis of the motion restraint 50, but not so snugly as to interfere with the passage of solution inside the tubing. In one embodiment, the interior of the outer member 52 comprises a gripping element 56 to aid in the gripping of tubing. The gripping element may be a ridge or protrusion extending from the interior surface of the outer member into the interior of the outer member. In one embodiment, the outer member may be cylindrical. Other shapes for the outer member are possible, with a cylindrical configuration being shown for illustrative purposes only. In an alternate embodiment, the motion restrain 50 comprises an adjustable flap, strap or similar structure (designated 60) secured to the base between any two of said securing members 16. At least a portion of the interior portion of strap 60 may comprise a gripping element as described above. The gripping element may be a ridge or a protrusion on said interior surface, a non-skid surface, or an adhesive. The strap 60 may be manufactured from any material desired. In one embodiment, the strap 60 is manufactured from a non-latex containing material. In yet another alternate embodiment, a specific example of a retaining device 1 having a non-ordered array is disclosed. In this embodiment, at least two of the retaining members 16 of the retaining device have an X and/or Y distance that is different from the average X and/or Y distance between the remaining securing members 16. In one case, at least two of the retaining members 16 of the retaining device have an X and/or Y distance that is less than the average X and/or Y distance between the remaining securing members 16. The securing members 16 having the different X and/or Y distances may be placed on the restraining device 1 in one corner of the array 100, in more than one corner of the array 100, in the center of the array 100, or any combination of the foregoing. Other locations on the array 100 may also be used. The closely spaced configuration of securing members 16 on the restraining device 16 may be useful for placement near or adjacent to the site of insertion of the tube 30 or near or adjacent to other areas of the tube 30 in need of additional restraint. The medical adhesive used in the present disclosure can be any medical adhesive currently in use. In one embodiment, the medical adhesive is non-allergenic and can be used repeatedly without irritation to the skin of the patient. In one embodiment, the medical adhesive is a hydro-colloidal adhesive. The hydro-colloidal adhesive presents the advantage of repelling water to the extent that showering and sweating do not degrade the integrity of the adhesive bond, as demonstrated by placement of a restraining devices described herein in excess of 14 days for securing a percutaneous endogastrostomy tube. One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objects and obtain the ends and advantages mentioned, as well as those inherent therein. It will be apparent to those skilled in the art that various modifications and variations can be made in practicing the present disclosure without departing from the spirit or scope of the invention. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the disclosure as defined by the scope of the claims. Any patents or publications mentioned in this specification are indicative of the levels of those skilled in the art to which the disclosure pertains. These patents and publications are herein incorporated by reference to the same extent as if it was indicated that each publication was incorporated specifically and individually by reference. The appended claim is added for the purpose of foreign priority only, if required.

Claims

CLAIMS hat is claimed:

1. A retaining device for securing a tube, said restraining device comprising: a) a base portion, said base portion having an upper side an a lower side; b) a plurality of securing members secured to said upper side of said base, said securing members being arranged in the form of an array and being separated from one another by a first distance and a second distance.

2. The restraining device of claim 1 where said array is an ordered array where said first and second distance between said securing members are equal.

3. The restraining device of claim 1 where said array is a non-ordered array where said first and second distance between said securing members are not all equal.

4. The restraining device of any of the preceding claims where said securing members have a uniform orientation with respect to one another.

5. The restraining device of any of the preceding claims where at least one of said securing members has a different orientation with respect to the remaining securing members.

6. The restraining device of any of the preceding claims where said restraining device has a custom configuration of said securing members.

7. The restraining device of any of the preceding claims where said restraining device has a custom configuration of said securing members, said custom configuration being determined by a user by selecting one or more of said securing members from said array.

8. The restraining device of any of the preceding claims where the restraining device further comprises a motion restraint, said motion restrain reversibly engaging said tube to limit a lateral movement of said tube between any two securing members.

9. The restraining device of claim 8 where said motion restrain comprises an outer member to engage said tube, said outer member having an opening along its long axis to allow reversible engagement of said tube and a gripping member to aid in securing said tube in said motion restraint.

10. The restraining device of claim 9 where said outer member is cylindrical.

11. The motion restrain of claim 8 where said motion restrain comprises an adjustable flap to receive said tube, said adjustable flap being secured to said base portion, between any two of said plurality of securing members.

12. The restraining device of claim 11 where at least a potion of the interior portion of said adjustable strap comprises a gripping element.

13. The restraining device of any of the preceding claims where said securing members comprising: a) a central portion secured to said base; and b) a plurality of arm members in communication with and extending outwardly from said central member, said arm members having a distal end and a proximal end, said arm members forming a channel to receive said tube.

14. The restraining device of any of the preceding claims where said arm members further comprise a gripping element to aid in securing said tube in said channel.

15. The restraining device of any of the preceding claims where said arm members further comprise a pinch portion, said pinch portion being in communication with said distal end of said arm members.

16. The restraining device of any of the preceding claims wherein said base is manufactured from a flexible material.

17. The restraining device of any of the preceding claims wherein said material is a plastic or a rubber.

18. The restraining device of any of the preceding claims where said material is selected from the group consisting of: silicone, fluorosilicone, latex rubber, polyvinylchloride, polycarbonate, polypropylene, polyurethane, acetal resin, cflex resin, polyethylene terephthalate, thermoplastic elastomers, nylon, polysulfone, polyaryletherketone and polyester.

19. The restraining device of any of the preceding claims wherein said material is non-allergenic.

20. The restraining device of any of the preceding claims where said material does not contain latex.

21. The restraining device of any of the preceding claims wherein said base further comprises a medical adhesive on said lower side.

22. The restraining device of any of the preceding claims where said medical adhesive is a hydrocolloidal material.

23 , The resfraining device of any of the preceding claims where said medical adhesive is non- allergenic.

24. The restraining device of any of the preceding claims where said medical adhesive is waterproof.

25. The restraining device of any of the preceding claims further comprising at least one of a removable cover on said lower side of said base or a protective cover on said upper side of said base.

26. The restraining device of claim 1 where said base comprise a color, a design configuration, or a combination of a color and a design configuration.

27. The restraining device of claim 1 where said design configuration is selected from the group consisting of: a geometric patter, an animal, a landscape scene, a logo, a cartoon character and a fairytale character.

28. The restraining device of claim 1 where in said tube is a medical tube.

29. The restraining device of claim 1 wherein said medical tube is selected from the group consisting of: a nasogastric tube for suction, a nasogastric tube for feeding, an indwelling urethral catheter, an intravenous tube, a chest tube, a drainage tube, an endogastrostomy tube, an indwelling Foley catheter, a suprapublic indwelling catheter and an oxygen tube.

30. A retaining device for securing a tube, said restraining device comprising: a) a base portion, said base portion having an upper side an a lower side; b) a first securing member secured to said upper side of said base; and c) a second securing member secured to said upper side of said base, said first and second securing members being separated from one another by a first distance and a second distance.

31. The resfraining device of claim 30 where said first and second distance between said securing members are equal.

32. The restraining device of claim 30 where said first and second distance between said securing members are not all equal.

33. The restraining device of any of the preceding claims where said securing members have a uniform orientation with respect to one another.

34. The restraining device of any of the preceding claims where said first securing members has a different orientation with respect to said second securing member.

35. The restraining device of any of the preceding claims where said restraining device has a custom configuration of said securing members.

36. The restraining device of any of the preceding claims where said restraining device has a custom configuration of said securing members, said custom configuration being determined by a user by selecting one or more of said securing members from said array.

37. The restraining device of any of the preceding claims where the restraining device further comprises a motion restraint, said motion restrain reversibly engaging said tube to limit a lateral movement of said tube between said first and second securing members.

38. The restraining device of claim 37 where said motion restrain comprises an outer member to engage said tube, said outer member having an opening along its long axis to allow reversible engagement of said tube and a gripping member to aid in securing said tube in said motion restraint.

39. The restraining device of claim 38 where said outer member is cylindrical.

40. The restraining device of claim 37 where said motion restrain comprises an adjustable flap to receive said tube, said adjustable flap being secured to said base portion, between any two of said plurality of securing members.

41. The restraining device of claim 40 where at least a potion of the interior portion of said adjustable strap comprises a gripping element.

42. The restraining device of any of the preceding claims where said securing members comprising: a) a central portion secured to said base; and b) a plurality of arm members in communication with and extending outwardly from said central member, said arm members having a distal end and a proximal end, said arm members forming a channel to receive said tube.

43. The restraining device of any of the preceding claims where said arm members further comprise a gripping element to aid in securing said tube in said channel.

44. The restraining device of any of the preceding claims where said arm members further comprise a pinch portion, said pinch portion being in communication with said distal end of said arm members.

45. The resfraining device of any of the preceding claims wherein said base is manufactured from a flexible material.

46. The restraining device of any of the preceding claims wherein said material is a plastic or a rubber.

47. The restraining device of any of the preceding claims where said material is selected from the group consisting of: silicone, fluorosilicone, latex rubber, polyvinylchloride, polycarbonate, polypropylene, polyurethane, acetal resin, cflex resin, polyethylene terephthalate, thermoplastic elastomers, nylon, polysulfone, polyaryletherketone and polyester.

48. The restraining device of any of the preceding claims wherein said material is non-allergenic.

49. The restraining device of any of the preceding claims where said material does not contain latex.

50. The restraining device of any of the preceding claims wherein said base further comprises a medical adhesive on said lower side.

51. The restraining device of any of the preceding claims where said medical adhesive is a hydrocolloidal material.

52. The restraining device of any of the preceding claims where said medical adhesive is non- allergenic.

53. The restraining device of any of the preceding claims where said medical adhesive is waterproof.

54. The restraining device of any of the preceding claims further comprising at least one of a removable cover on said lower side of said base or a protective cover on said upper side of said base.

55. The restraining device of claim 1 where said base comprise a color, a design configuration, or a combination of a color and a design configuration.

56. The restraining device of claim 1 where said design configuration is selected from the group consisting of: a geometric patter, an animal, a landscape scene, a logo, a cartoon character and a fairytale character.

57. The restraining device of claim 1 where in said tube is a medical tube.

58. The restraining device of claim 1 wherein said medical tube is selected from the group consisting of: a nasogastric tube for suction, a nasogastric tube for feeding, an indwelling urethral catheter, an intravenous tube, a chest tube, a drainage tube, an endogastrostomy tube, an indwelling Foley catheter, a suprapublic indwelling catheter and an oxygen tube.