Patent Publication Number: US-2020297470-A1

Title: Pet grooming and skin care tool and methods of making and using the tool

Description:
BACKGROUND 
     Male incontinence is a worldwide problem. It can be the byproduct of a wide variety of health issues, including aging, prostate surgery or sphincterotomy, medications, kidney disease, and others. Incontinence can have a major impact on one&#39;s lifestyle. The inability to control urination can affect almost every activity, resulting from fear of consequence or embarrassment. 
     Nursing homes, with an elderly male population, have a great need for a solution to this problem, which also demands staff attention throughout the day. The impact on active younger men with incontinence may be even greater. Early diagnosis of prostate cancer followed by surgery, for example, can lead to many years or decades of daily lifestyle modifications. 
     Stopping involuntary urinary flow can be achieved by adequately restricting the urethra, but doing so throughout the day while not causing discomfort or inconvenience has proven to be the challenge. Present art is focused on impeding urinary flow while compromising comfort and convenience. Hard-body mechanisms, including clamps and encirclement devices that wrap around the penis circumference, or otherwise, are unyielding and subject to movement when periodic forces are applied when the user is active. Even normal body movement will place periodic asymmetric pressures on such devices, thereby imparting forces which may cause a displacement and/or discomfort. The present art requires removal, adjustment, or repositioning prior to regular urinations. After urination, the process is reversed. Such demands do not always suit the circumstances when the need for urination arises. Convenience is not a medical term, but to many users it can also be a fundamental requirement in addition to comfort, effective urinary control, and limited impact on blood circulation. 
     Accordingly, a need exists for a male incontinence control device that is convenient to use and performs well without discomfort or required management throughout the day prior to, during, or after urination. 
     SUMMARY OF THE INVENTION 
     The invention is directed to a male incontinence control device and related methods of using the device. 
     In a first embodiment, the male incontinence control device is a male incontinence control device that includes (a) a single-piece continuous loop of an elastic compression band defining a lumen, the elastic compression band configured and arranged to securely encircle a flaccid penis without inflicting penile ischemia, and (b) an inwardly projecting bump on the elastic compression band configured and arranged for pressing against and constricting the urethra of a wearer. 
     In a second embodiment, the male incontinence control device is (a) a continuous looped band of material defining a lumen wherein the band has an integrated first elastic length and a second inelastic length, and is configured and arranged to securely encircle a flaccid penis without inflicting penile ischemia, and an inwardly projecting bump on the band configured and arranged for pressing against and restricting the urethra of a wearer. 
     The lumen of the male incontinence control device preferably has an elliptic cross-section with a major axis centered through a top and bottom portion of the elastic compression band and a minor axis centered through side portions of the elastic compression band, and the volumetric center of the bump is essentially aligned with the minor axis. 
     The device preferably includes diametrically opposed first and second removal loops extending radially outward from the elastic compression band in alignment with the minor axis of the lumen, with the removal loops configured and arranged to accommodate passage of at least one fingertip through each removal loop to facilitate manual outward radial stretching of the elastic compression band. 
     The device is operable for controlling male incontinence, by (i) manually radially stretching the continuous elastic compression band so as to enlarge the lumen, (ii) inserting the penis of a male in need of incontinence control through the enlarged lumen with the bump on the device positioned proximate the underside of the penis, and (iii) releasing the band whereby the band contracts around the shaft of the penis, and the bump presses against and restricts the urethra. 
     A male wearing the device can urinate while wearing the device by consciously initiating voiding of his bladder without adjusting or removing the device, whereby (i) the bladder contracts, (ii) the bladder outlet relaxes, and (iii) the flow of urine within the urethra exerts a pressure sufficient to overcome the pressure exerted upon the urethra by the bump on the device so as to permit micturition. 
     The device, when equipped with removal loops, can be removed from operable engagement with a penis by (i) inserting at least one finger tip from a first hand into the first removal loop, and inserting at least one finger tip from a second hand into the second removal loop, (ii) manually stretching the elastic compression band so as to enlarge the lumen by pulling the loops away from one another, and (iii) sliding the manually stretched elastic compression band off the penis. 
     The device, when equipped with removal loops, can also be removed from operable engagement with a penis by (i) inserting at least a first and a second finger tip from a first hand into the first removal loop, and inserting at least a first and a second finger tip from a second hand into the second removal loop, (ii) manually radially stretching the elastic compression band so as to enlarge the lumen by both pulling the loops away from one another and expanding the first and second finger tips in each removal loop away from one another, and (iii) sliding the manually stretched elastic compression band off the penis. 
     An object of this invention is to provide a male incontinence control device that can be worn in comfort day and night, constructed of elastomeric material or compounds including, but not limited to, Silicone rubber, natural Rubber, Thermoplastic Elastomers (TPE), Thermoplastic Rubbers (TPR) and similar elastomer and elastomeric materials. 
     Another object of this invention is to provide a male incontinence control device that allows normal blood circulation to the penis while being worn for extended periods of time. 
     Another object of this invention is to provide a male incontinence control device that significantly impedes involuntary urinary flow. 
     Another object of this invention is to provide a male incontinence control device that typically requires no management or adjustment before, during, or after urination. 
     Another object of this invention is to provide a male incontinence control device that minimizes skin irritations. 
     Another object of this invention is to provide a male incontinence control device that is adjustable in tension by removal of material. 
     Another object of this invention is to provide a male incontinence control device that can be worn while sleeping. 
     Another object of this invention is to provide a male incontinence control device that does not require adjustment from a day&#39;s beginning to end, after the initial adjustment/fitting. 
     Another object of this invention is to provide a male incontinence control device that is easy to don and doff. 
     Another object of this invention is to provide a male incontinence control device that may employ an integrated protrusion disposed at the lower interior of the main sleeve body that can be modified in size or hardness by the use of inserts or caps to increase or decrease the height, length, width and/or hardness of said protrusion. 
     Another object of this invention is to provide a male incontinence control device constructed of a flexible body that allows urine to flow through the point of constriction, when urinary pressures within the urethra are increased, without prior adjustment or removal of the device. 
     Another object of this invention is to provide a male incontinence control device that additionally improves performance in impeding involuntary leakage when sitting. 
     Another object of this invention is to provide a male incontinence control device that may employ an integrated protrusion disposed at the lower interior of the main sleeve body which contains a harder insert molded core element to provide a firmer protrusion. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of one embodiment of the invention. 
         FIG. 2  is a front view of the invention depicted in  FIG. 1 . 
         FIG. 3  is a side view of the invention depicted in  FIG. 1 . 
         FIG. 4  is a top view of the invention depicted in  FIG. 1 . 
         FIG. 5  is a cross-sectional view of the invention depicted in  FIG. 2  taken along line  5 - 5 . 
         FIG. 6  is a side view of the invention depicted in  FIG. 1  equipped with axial wings. 
         FIG. 7  is a top view of the invention depicted in  FIG. 6 . 
         FIG. 8  is a front view of a second embodiment of the invention and multiple spherical objects configured and arranged for selective insertion into the bump. 
         FIG. 9  is a cross-sectional view of a second embodiment of the invention equipped with a generally spherical object replaceably captured within the bump. 
         FIG. 10  is an exploded perspective view of a third embodiment of the invention having a detachable and replaceable bump. 
         FIG. 11  is a perspective view of the third embodiment of the invention depicted in  FIG. 10  with the bump attached to the band. 
         FIG. 12  is a side view of the invention depicted in  FIGS. 1-5  worn by an individual. 
         FIG. 12  is a front view of a fourth embodiment of the invention. 
     
    
    
     DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT 
     Definitions 
     As utilized herein, including the claims, the phrase “essentially aligned”, when used in reference to the position of the volumetric center of the bump relative to the minor axis of the lumen, means less than about 2 mm distance from the minor axis along a 90° straight-line. 
     As utilized herein, including the claims, the phrase “generally spherical object” means an object having no sharp edges or corners, such as a sphere, a torus, an ellipsoid, an egg-shaped object, a pear-shaped object, a 100-sided polyhedron, etc. 
     
       
         
           
               
            
               
                   
               
               
                 Nomenclature Table 
               
            
           
           
               
               
               
            
               
                   
                 Ref. No. 
                 Name 
               
               
                   
                   
               
               
                   
                 100 
                 Male Incontinence Control Device 
               
               
                   
                 110 
                 Elastic Compression Band 
               
               
                   
                   
                 Elastic Cylindrical Annulus 
               
               
                   
                   
                 Sleeve 
               
               
                   
                 110a 
                 Top Portion of Elastic Compression Band 
               
               
                   
                 110b 
                 Bottom Portion of Elastic Compression Band 
               
               
                   
                 110s 
                 Side Portions of Elastic Compression Band 
               
               
                   
                 119 
                 Lumen Through the Elastic Compression Band 
               
               
                   
                   
                 Void 
               
               
                   
                 119α 
                 Axial Directions of Lumen 
               
               
                   
                 119α 1   
                 Forward Axial Direction of Lumen 
               
               
                   
                 119α 2   
                 Rearward Axial Direction of Lumen 
               
               
                   
                 119β 
                 Radial Directions of Lumen 
               
               
                   
                 119x 
                 Length of Lumen 
               
               
                   
                 120 
                 Bump 
               
               
                   
                   
                 Protrusion 
               
               
                   
                 130 
                 Removal Appliances (Loops) 
               
               
                   
                   
                 Gripping Appendages 
               
               
                   
                 131 
                 First Removal Appliance 
               
               
                   
                 132 
                 Second Removal Appliance 
               
               
                   
                 140 
                 Radial Wings 
               
               
                   
                 141 
                 First Radial Wing 
               
               
                   
                 142 
                 Second Radial Wing 
               
               
                   
                 150 
                 Axial Wings 
               
               
                   
                 151 1   
                 First Forward Axial Wing 
               
               
                   
                 152 1   
                 Second Forward Axial Wing 
               
               
                   
                 151 2   
                 First Rearward Axial Wing 
               
               
                   
                 152 2   
                 Second Rearward Axial Wing 
               
               
                   
                 200 
                 Insert 
               
               
                   
                 300 
                 Post for Detachable Mounting of Bump 
               
               
                   
                 410 
                 Inelastic Length of Band 
               
               
                   
                 420 
                 Elastic Length of Band 
               
               
                   
                 430 
                 Connection Mechanism 
               
               
                   
                 P 
                 Penis 
               
               
                   
                 P 1   
                 Shaft of Penis 
               
               
                   
                 P 2   
                 Underside of Penis 
               
               
                   
                 S 
                 Scrotum 
               
               
                   
                 U 
                 Urethra 
               
               
                   
                 W 
                 Wearer 
               
               
                   
                   
               
            
           
         
       
     
     Construction 
     The male incontinence control device  100  is designed with comfort being one objective. It is constructed with a low modulus of elasticity elastomer material that allows the user to remain unaware of its presence throughout the day, when properly sized. 
     The male incontinence control device  100  is preferably configured and arranged not to completely impede urinary flow, but to greatly reduce involuntary urine flow while remaining comfortable to wear without inconvenience. In its preferred configuration and arrangement, persons wearing the device  100  may experience minor leakage for a variety of reasons throughout the day. Sudden increases in intravesical pressure may be generated when lifting a heavy weight, pressures from a full bladder, involuntary relaxation of the sphincter, or simply coughing or sneezing, in addition to urge incontinence. 
     The profile of the male incontinence control device  100  is modest in each dimension, which minimizes body contact and any tendency for movement. Comfort is directly related to the degree of constriction, which affects blood flow, and friction. Friction is created by contact pressures and movement between the device  100  and the surface of the skin. 
     Referring generally to  FIGS. 1-5 , according to the principles of the invention, the main body construction of the male incontinence control device  100  is a generally elastic cylindrical annulus, referred to herein as a sleeve or continuous loop elastic compression band  110 , and an integrated protrusion, referred to herein as a bump  120 , on the interior wall. The band  110  and bump  120  are preferably formed as a single-piece. Attached gripping appendages, referred to herein as removal appliances or removal loops  130 , are preferably provided. 
     Referring generally to  FIGS. 1 and 2 , the outer surface and the inner surface of the sleeve  110  defines the majority of the body of the sleeve  110 . The inner face of the sleeve  110  bounds a cylindrical void, referred to herein as a lumen  119 , which receives the penis P in the applied condition. The inner circumference of the sleeve  110  corresponds to, but is less than that of the flaccid penis P so as to securely encircle the flaccid penis P without inflicting penile ischemia. 
     An elastic compression band  110  having a thickness of 1 to 5 mm and defining a lumen  119  having an axial length of 1 to 2 cm is generally effective for providing a combination of comfort and superior performance. 
     The continuous loop elastic compression band  110  can be conveniently demarcated for purposes of describing the relative location of features and components on the continuous loop elastic compression band  110  as having a top portion  110   a , a bottom portion  110   b , and side portions  110   s . The lumen  119  defines an axial direction  119 α and radial directions  119 β. The axial direction  119 α has a forward axial direction  119 α 1  and a rearward axial direction  119 α 2 . The lumen  119  has an axial length  119   x.    
     The lumen  119  can have an elliptic cross-section with a major axis centered through the top  110   a  and bottom  110   b  portions of the elastic compression band  110  and a minor axis centered through the side portions  110   s  of the elastic compression band  110 . 
     The continuous loop elastic compression band  110  provides a relatively large cylindrical surface area in contact with the surface of the penis P relative to that of the small integrated protrusion  120  deposed at the lower  110   b  interior of the main sleeve body  110  which concentrates upward pressure on the urethra U located on the underside P 2  of the penis P to impede urinary flow. This spreads constriction forces over a larger area around the perimeter of the penis P, relative to other configurations such as a cylindrical shaped (cross-section) loop, thereby allowing for normal blood flow and avoiding penile ischemia by minimizing constriction pressure. The distributed constriction force results in low pressures on the grouping of veins, arteries, and nerves commonly referred to as the neurovascular bundle, which ensures normal circulation and comfort. 
     The continuous cylindrical sleeve  110  is composed of a rubber, silicone or other elastomer commonly known to the trade. The sleeve  110  preferably has (i) a shore durometer of 5 A to 30 A, (ii) a low modulus of elasticity (i.e., a Young&#39;s Modulus of 5 to 30 psi and preferably 5 to 20 psi), and (iii) an ultimate elongation of at least 100%. A durometer of less than about 5 A tends to provide insufficient constriction force when used, while a durometer of greater than about 30 A tends to be excessively difficult to stretch when donning and doffing the device  100 . Similarly a modulus of elasticity of less than about 5 psi tends to provide insufficient constriction force when used, while a modulus of elasticity of greater than about 30 psi tends to be excessively difficult to stretch when donning and doffing the device  100 . Finally, an ultimate elongation of less than 100% tends to be excessively difficult to stretch a sufficient amount when donning and doffing the device  100 . 
     Referring generally to  FIGS. 1, 2 and 5 , an integrated protrusion  120  is deposed on the inner wall of the continuous cylindrical sleeve  110  at the bottom  110   b , extending radially inwardly and upward when in the applied condition for pressing against and constricting the urethra U of a wearer W. 
     A bump  120  which radially extends 5 to 15 mm into the lumen  119  is generally effective for providing a combination of comfort and superior performance. 
     In the preferred embodiment, the bump  120  has an uppermost convex surface, and is integrally attached to the lower  110   b  interior of the inner wall of the sleeve  110 . The bump  120  preferably projects radially inward  119 β directly towards the center of the lumen  199 . Other embodiments may include, but are not limited to, protrusions composed of caps or inserts, which may not be an integral component to the sleeve  110  itself. 
     Referring generally to  FIGS. 8-11 , the bump  120  may be of solid elastomer material or may incorporate a variety of insert/snap-on components  200  of different size, shape and/or hardness (durometer) for insertion into a void within the bump  120  to increase hardness, adding to upward pressure on the urethra U. Alternatively, bumps  120  of different size, shape and/or hardness (durometer) may selectively attachable to the continuous cylindrical sleeve  110  via an inwardly projecting post  300  on the sleeve  110  to adjust upward pressure on the urethra U. 
     Referring generally to  FIGS. 2 and 5 , when the lumen  119  defined by the continuous loop elastic compression band  110  has an elliptic cross-section, the volumetric center of the bump  120  is preferably essentially aligned with the minor axis of the lumen  119 . 
     Referring generally to  FIGS. 1-5 , the male incontinence control device  100  may have gripping appendages, referred to herein as removal appliances or removal loops  130  in the preferred embodiment, integrally attached to the continuous cylindrical sleeve  110 . A first removal appliance  131  is deposed at the upper perimeter outer wall  110   a  extending radially outward, and an opposed second removal appliance  132  is deposed at the lower perimeter outer wall  110   b . The lower removal appliance  132  may be attached at a forward  119 α 1  angle to the main body  110  and a forward  119 α 1  angle when in the applied condition. This forward  119 α 1  bias from a horizontal or vertical axis, which is directed away from the body, can reduce contact with skin around the penis P. 
     The removal appliances  130  may be of any shape capable of allowing the continuous cylindrical sleeve  110  to be manipulated as necessary with ease and efficiency. Elderly men or those with impaired vision or dexterity should have little difficulty placing the device  100  into the proper position, particularly when the removal appliances  130  are formed as loops. 
     Referring generally to  FIGS. 1-5 , the removal appliances  130  are preferably configured and arranged for manual fingertip engagement to facilitate manual outward radial stretching of the elastic compression band  110 . For ease of use, the removal appliances  130  are preferably diametrically opposed removal loops configured and arranged to accommodate passage of at least one fingertip and preferably two fingertips through each removal loop to facilitate manual outward radial stretching of the elastic compression band  110 . When the lumen  119  defined by the continuous loop elastic compression band  110  has an elliptic cross-section, the removal appliances preferably extend radially outward from the elastic compression band in alignment with the minor axis of the lumen  119 . 
     Referring generally to  FIGS. 1, 3, 5 and 12 , the removal appliance  130  closest to the bump  120  will typically contact and rub against the scrotum S during normal usage. In order to minimize any discomfort this removal appliances  130  can be angled axially forward  119 α 1  from the elastic compression band  110 . To further minimize any discomfort this scrotum-engaging removal appliances  130  preferably curves axially forward  119 α 1  from the elastic compression band  110  at a radius of curvature of between about 1 to 2 cm, with the understanding that the curvature may be a compound curve with or without some linear segments which approximates a radius of curvature of between about 1 to 2 cm. 
     The gripping appendages  130  of other embodiments may be of another shape, size, material and position, lending to aesthetic or functional qualities. 
     Referring generally to  FIGS. 1-4 , the male incontinence control device  100  may include opposed trimmable appendages, referred to herein as radial wings  140  extending radially outward from the continuous loop elastic compression band  110 . 
     The radial wings  140  preferably have an axial  119   a  length of less than ½ that of the elastic compression band  110  so as to provide a limited area of increased radial thickness of elastic material to the side portions  110   s  of the elastic compression band  110 . 
     In a preferred embodiment, the opposed removable radial wings  140  project laterally (i.e., radially) from the side portions  110   s  of the sleeve  110  outer wall a radial distance of between 2 and 10 mm when in the applied condition, with a first radial wing  141  projecting from a first side portion and a second radial wing  142  projecting from a second side portion. The radial wings  140  are preferably constructed of the same soft elastic material as the sleeve  110 , sufficient in volume to increase sleeve  110  tension when in the applied condition and therefore, when removed or reduced, will decrease tension to adjust for varying user needs. 
     To adjust for proper tension and to ensure normal blood circulation when in the applied condition, the opposing radial wings  140  may be trimmed using common scissors to incrementally remove material. 
     Referring generally to  FIGS. 6 and 7 , the male incontinence control device  100  may, in addition to or instead of the radial wings  140 , include forward  119 α 1  and/or rearward  119 α 2  extending pairs of laterally opposed trimmable appendages, referred to herein as axial wings  150  extending from the continuous loop elastic compression band  110 . 
     The removable axial wings  150  project longitudinally (i.e., axially) forward  119 α 1  and/or rearward  119 α 2  from the side portions  110   s  of the sleeve  110  an axial distance of between 2 and 10 mm when in the applied condition. A first forward axial wing  1511  projects from a first side portion  110   s  and a second forward axial wing  1521  projects from a second side portion  110   s . In similar fashion, a first rearward axial wing  1512  projects from a first side portion  110   s  and a second rearward axial wing  1522  projects from a second side portion  110   s . The axial wings  150 , as with the radial wings  140  are preferably constructed of the same soft elastic material as the sleeve  110 , sufficient in volume to increase sleeve  110  tension when in the applied condition and therefore, when removed or reduced, will decrease tension to adjust for varying user needs. 
     To adjust for proper tension and to ensure normal blood circulation when in the applied condition, the axial wings  150  may, as with the radial wings  140 , be trimmed using common scissors to incrementally remove material. 
     Other embodiments may include removable features of another shape or size sufficient to modify functional qualities. 
     The male incontinence control device  100  (i.e., the continuous loop elastic compression band  110 , bump  120 , removal appliances  130  and radial wings  140 ) may be formed as a unitary molding of the elastomer material, employing injection, transfer, or compression molding processes. 
     Other embodiments may incorporate rigid inelastic sections within the cylindrical annulus  110 , which may be composed of, but not limited to, thermoplastics including ABS, polypropylene and nylon or thermosetting materials including phenolic and melamine, ceramics or hard elastomers, in addition to section(s) of soft elastic material. Referring generally to  FIG. 13 , one example of an embodiment incorporating a rigid inelastic section is a continuous loop band  110  formed from a rigid upper section body  410  and a flexible lower section  420  connected by a suitable connection mechanism  430 . The ratio between the peripheral length of the rigid upper section body  410  and the peripheral length of the flexible lower section  420  can be varied. 
     Those skilled in the art will recognize that changes and modifications may be made in the described embodiments without departing from the nature and scope of the present invention. To the extent that such modifications and variations do not depart from the spirit of the invention, they are intended to be included within the scope thereof. 
     Method of Donning to Control Incontinence 
     The device  100  is operable for controlling male incontinence, by (i) manually radially stretching the continuous elastic compression band  110  so as to enlarge the lumen  119 , (ii) inserting the penis P of a male W in need of incontinence control through the enlarged lumen  119  with the bump  120  on the device  100  positioned proximate the underside P 2  of the penis P, and (iii) releasing the band  110  whereby the band  110  contracts around the shaft P 1  of the penis P, and the bump  120  presses against and restricts the urethra U. 
     Expanding the sleeve  110  for application to the shaft Pi of the penis P near the base can be achieved by insertion of the index finger and middle finger (not shown) of each hand (not shown) into the sleeve  110  center and pulling in opposite directions. The low modulus characteristic of the elastomer allows the unit  110  to be stretched sufficiently prior to positioning in the applied condition. The removal therefrom can be achieved by use of the respective gripping appendages  130 , when stretched in opposite radial directions. 
     The proper unit size and/or tension for different users varies, which could be addressed by manufacturing different size devices  100 . This invention partially addresses such sizing needs with its design. Users W requiring less tension can remove material from the radial ring (i.e., the radial wings  140 ) outside the main body  110 . After the proper tension is established, no additional sizing or adjustments should be necessary. 
     Urinating while Wearing the Device 
     Removal or adjustment of the device  100  is not necessary prior to, during, or after urination, due to the flexible characteristics of the soft body construction. 
     A male W wearing the device  100  can urinate while wearing the device  100  by consciously initiating voiding of his bladder without adjusting or removing the device  100 , whereby (i) the bladder contracts, (ii) the bladder outlet relaxes, and (iii) the flow of urine within the urethra exerts a pressure sufficient to overcome the pressure exerted upon the urethra by the bump  120  on the device  100  so as to permit micturition. 
     Overnight Use 
     When necessary or desired, the device  100  may be worn throughout the night. However, it is recommended that the device  100  be positioned forward from the base of the penis P to gain skin relief after daytime use positioned at or near the base. During daytime use, if positioned forward, performance would normally be degraded, but not so at night, due to reduced intravesical pressures when lying down. 
     Method of Doffing 
     The device  100 , when equipped with removal loops  130 , can be removed from operable engagement with a penis P by (i) inserting at least one finger tip from a first hand into a first removal loop  131 , and inserting at least one finger tip from a second hand into the other removal loop  132 , (ii) manually stretching the elastic compression band  110  so as to enlarge the lumen  119  by pulling the loops  130  away from one another, and (iii) sliding the manually stretched elastic compression band  110  off the penis P. 
     Alternatively, a wearer W can insert at least a first and a second finger tip from a first hand into the first removal loop  131 , and inserting at least a first and a second finger tip from a second hand into the other removal loop  132 , and then, in addition to manually stretching the elastic compression band  110  so as to enlarge the lumen  119  by pulling the loops  130  away from one another, expanding the first and second finger tips in each removal loop  130  away from one another.