Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Patent Application No. 61/515,774, filed on Aug. 5, 2011, which is expressly incorporated herein in its entirety by reference thereto. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to a therapeutic garment, apparatus, method, and system having inflatable bladders. 
       BACKGROUND OF THE INVENTION 
       [0003]    U.S. Pat. No. 7,823,219 (“the &#39;219 patent”), which issued on Nov. 2, 2010 and which is incorporated herein in its entirety by reference thereto, describes a therapeutic pressure-relieving device and method for preventing and treating pressure sores (i.e., decubitus ulcers) on a patient&#39;s body. The device of the &#39;219 patent is intended to prevent and treat pressure sores by alleviating pressure on tissue covering and surrounding bony prominences of the patient&#39;s body and by alleviating pressure on the blood vessels in the angiosomes to promote blood flow. The device of the &#39;219 patent uses a plurality of inflatable channels or pockets which are selectably inflatable to alleviate pressure while allowing blood to flow throughout the angiosomes. 
         [0004]    Although the device of the &#39;219 patent is configured to alleviate pressure sores in particular regions of the patient&#39;s body, it is also desirable to roll the patient&#39;s body, as described in further detail below. 
         [0005]    Pressure sores may be considered a function of pressure that is exerted on a soft tissue surface of the body greater than 32 mm Hg for a substantial period of time. One way to minimize or at least reduce this problem is to manually roll the patient from side to side at a relatively high frequency. This is sometimes referred to as “log rolling.” Problems with this treatment include increased nursing requirements, delays between rolling treatments, and sheer forces on the skin during the “rolling” procedure. Also, abrupt and relatively rapid rolling may tend to cause discomfort to the patient. 
         [0006]    Accordingly, there is believed to be a need for a device and method that provides the benefits of rolling the patient while reducing manual labor requirements, trauma to the patient&#39;s tissue, and patient discomfort associated with such rolling. 
         [0007]    Further, especially for hospitalized, bed-ridden patients, pulmonary function may be reduced from normal levels for various reasons. A factor in pulmonary disease occurrence is the inability to clear fluid build-up in the lungs. As the fluid accumulates, the risk of pneumonia and pulmonary desaturation may increase. Thus, there is a need for a device and method for facilitating pulmonary function, especially for bed-ridden patients. 
         [0008]    There is also believed to be a need to apply automatically percussive treatment to break up inspissated fluids within the patient&#39;s lungs, reducing surface tension, so as to allow secretions to be mobilized and expectorated, while reducing the need for nurses and pulmonary therapists to provide such treatment. 
         [0009]    Especially for a closed garment, such as, for example, the device of the &#39;219 patent, a limiting feature in a debilitated patient may include the risk of undiagnosed fecal or urinary soilage. This soilage may result in skin breakdown, wound infection, and/or patient discomfort. If the garment is closed, nurses may have a limited opportunity to examine the patient. Accordingly, there is believed to be a need for detection devices and methods for detecting urinary and fecal soilage and alerting nurses to these occurrences, so as to inform or signal the nurses to perform a garment change, so as to reduce the amount of time spent by the nurses checking on soilage of patients. 
         [0010]    Furthermore, many patients may undergo cardiac catheterization and other invasive procedures that may require access from the large blood vessels (such as, for example, the groin area). After these procedures are completed, catheters are removed and the puncture wound in the blood vessels may bleed for hours. To circumvent this bleeding, a nurse places pressure on the blood vessels or places a “brick” or “sand-bag” on the area (for example, for up to one hour). Each of these solutions is complicated by patient discomfort and the risk of bleeding if the pressure brick/bag shifts so that it no longer properly puts pressure on the blood vessel. 
         [0011]    Thus, there is believed to be a need for an apparatus and method that effectively applies pressure during invasive procedures (for example, catheterization procedures), without relying upon manually applied pressure and/or the placement of a weight on the patient&#39;s body in the area where the bleeding occurs. In this regard, there is believed to be a need for devices and methods that minimize bleeding, conform to the patient&#39;s anatomy, and/or have an integrated bleeding alarm to alert a nurse if bleeding occurs. 
         [0012]    To further facilitate prevention of pressure sores and improve patient comfort, there is also believed to a need for an apparatus and method for distributing a gas to a patient&#39;s skin to reduce moisture and perspiration. 
       SUMMARY OF THE INVENTION 
       [0013]    Example embodiments of the present invention may be used in combination with or separate and apart from the device and method of the &#39;219 patent. 
         [0014]    In accordance with example embodiments and/or methods of the present invention, a therapeutic garment includes: at least one first expandable bladder configured to underlie a wearer&#39;s left shoulder blade; at least one second expandable bladder configured to underlie the wearer&#39;s right shoulder blade; and an actuator configured to alternatingly (a) expand the at least one first expandable bladder from a collapsed state to an expanded state such that the wearer&#39;s torso is rolled in a rightward direction and (b) expand the at least one second expandable bladder from a collapsed state to an expanded state such that the wearer&#39;s torso is rolled in a leftward direction. 
         [0015]    In accordance with the example embodiments and/or methods of the present invention, the at least one first expandable bladder may be elongated with a longitudinal axis parallel to the wearer&#39;s anteroposterior axis, and the at least one second expandable bladder may be elongated with a longitudinal axis parallel to the wearer&#39;s anteroposterior axis. 
         [0016]    In accordance with the example embodiments and/or methods of the present invention, the rate of the alternating rolling may be adjustable. 
         [0017]    In accordance with the example embodiments and/or methods of the present invention, the garment may include at least one percussive mechanism to transmit at least one of (a) ultrasonic waves and (b) a direct percussive effect, to the wearer&#39;s lungs. 
         [0018]    In accordance with the example embodiments and/or methods of the present invention, at least one percussive mechanism may be disposed in the at least one first expandable bladder and the at least one second bladder. 
         [0019]    In accordance with the example embodiments and/or methods of the present invention, the garment may include at least one vibratory mechanism configured to transmit vibrations to the wearer&#39;s lungs. 
         [0020]    In accordance with the example embodiments and/or methods of the present invention, the at least one vibratory mechanism may be disposed in the at least one first expandable bladder and the at least one second expandable bladder. 
         [0021]    In accordance with the example embodiments and/or methods of the present invention, the garment may include at least one control panel to set at least one of (a) an intensity of treatment, (b) a duration of treatment, and (c) a frequency of treatment. 
         [0022]    In accordance with the example embodiments and/or methods of the present invention, the garment may include at least one sensor to detect at least one of (a) urinary soilage and (b) fecal soilage. 
         [0023]    In accordance with the example embodiments and/or methods of the present invention, the garment may include an alarm that is configured to be triggered by the at least one sensor upon the detection of at least one of (a) urinary soilage and (b) fecal soilage. 
         [0024]    In accordance with the example embodiments and/or methods of the present invention, the garment may include at least one third expandable bladder configured to exert a pressure on a vascular access of the wearer that is sufficient to reduce bleeding from the vascular access. 
         [0025]    In accordance with example embodiments and/or methods of the present invention, a method for reducing bleeding in connection with an invasive procedure conducted on a patient includes: disposing at least one expandable bladder adjacent a vascular access of the patient; and expanding the at least one expandable bladder to exert a pressure onto the patient&#39;s tissue sufficient to minimize bleeding from the vascular access. 
         [0026]    In accordance with example embodiments and/or methods of the present invention, a method for rolling a patient includes: providing at least one first expandable bladder below the patient&#39;s left shoulder blade; providing at least one second expandable bladder below the patient&#39;s right shoulder blade; and alternatingly expanding and collapsing the at least one first expandable bladder and the at least one second expandable bladder so that the wearer&#39;s torso is alternately rolled in a rightward direction and a leftward direction. 
         [0027]    In accordance with example embodiments and/or methods of the present invention, a therapeutic apparatus is provided as a garment with two or more expandable bladders (or “pontoons”), which are configured to extend under each of the patient&#39;s shoulder blades. The expandable bladders are configured to inflate and deflate in an alternating pattern to so as to roll the patient side-to-side in correspondingly alternating directions. This side-to-side rolling is intended to prevent and/or reduce pressure sores, as well as improve pulmonary hygiene (i.e., pulmonary toilet). 
         [0028]    Example embodiments and/or methods of the present invention include an apparatus, system, and method for rolling the patient, with the expandable bladders, side-to-side in a motion sequence. As the patient rolls side-to-side in a “rolling” process, the risks of pressure sores, which may already be diminished by the garment, are believed to be reduced further. The slow rolling apparatus and method is also believed to be more comfortable for the patient than an abrupt rolling side-to-side to the other by nurses, who may be rushed to perform this maneuver in an expedient manner (such as, for example, due to time pressure). The expandable bladder system is also intended to reduce the amount of nursing care required by eliminating the labor intensive manual rolling procedure. 
         [0029]    In accordance with the example embodiments and/or methods of the present invention, the “rolling” is also intended to improve pulmonary function by shifting the position of the patient, so as to liberate fluid secretions that have accumulated within the patient&#39;s lungs and help at least reduce the risk of pneumonia. 
         [0030]    In accordance with example embodiments and/or methods of the present invention, multiple expandable bladder systems (for example, two to six expandable bladders) are oriented vertically, i.e., along or parallel to the patient&#39;s anteroposterior axis, as part of a pressure-sore-reducing garment. The expandable bladders may extend the vertical length of the garment and/or may extend up to the top of the shoulders. The expandable bladders are configured to inflate and deflate in a manner so that the patient gently rolls back and forth. The rate and/or frequency of rolling may be adjusted, for example, with the pump mechanism. 
         [0031]    In accordance with example embodiments and/or methods of the present invention, to enhance the pulmonary hygiene function, percussive mechanisms may be included or integrated with the expandable bladders to create a percussive effect to help mobilize sequestered secretions within the lungs of debilitated and/or bed-ridden patients. Such percussive treatments are intended to break up inspissated fluids within the lungs and reduce surface tension, so as to allow secretions to be mobilized and expectorated. Such devices and methods are intended to reduce the need for nurses and pulmonary therapists to provide manual percussive treatments. Also, because the treatment mechanism is included or integrated with the garment, percussive therapy may be increased in frequency since it may be controlled in an automated manner. 
         [0032]    In accordance with the example embodiments and/or methods of the present invention, the percussive mechanisms may be provided, for example, within the pontoons, as a mechanical device that imparts percussive waves in the form of ultrasonic waves and/or direct percussion onto the patient&#39;s back, so as to transmit the percussive waves into the patient&#39;s lungs. The device may have one or more control panels that determine the intensity, duration and/or frequency of treatment. 
         [0033]    In accordance with the example embodiments and/or methods of the present invention, the therapeutic apparatus may include sensors for urinary and/or fecal soilage, which are configured to alert nurses to the occurrence of urinary and/or fecal soilage, and for signaling the nurses to perform a garment change. The sensors may also allow nurses to spend less time checking patients for urinary and fecal soilage. 
         [0034]    In accordance with the example embodiments and/or methods of the present invention, the sensors may be integrated into the garment and may be associated with an alarm disposed, for example, within the pump mechanism. 
         [0035]    In accordance with example embodiments and/or methods of the present invention, a vascular compression garment, for post-vascular access patients, includes pressure bladders that provide only enough pressure to minimize or at least reduce bleeding in connection with invasive procedures (such as, for example, cardiac catheterizations). The pressure bladders may conform to the patient&#39;s body and/or have an integrated bleeding alarm to alert nurses if bleeding occurs. The garment may be integrated with the therapeutic garment described above or provided as a separate and stand-alone apparatus. 
         [0036]    In accordance with the example embodiments and/or methods of the present invention, the garment may be included or integrated with a larger garment that limits shifting so that pressure is only placed where it is anatomically needed. This larger garment may be, for example, the therapeutic apparatus as described above. 
         [0037]    In accordance with example embodiments of the present invention, an expandable bladder system includes an expandable bladder having a semi-permeable material to allow a gas, such as air, to pass across the semi-permeable membrane to reduce skin moisture and perspiration of a patient. 
         [0038]    Further features and aspects of example embodiments and/or methods of the present invention are described in more detail below with reference to the appended Figures. Additional specific embodiments, aspects and advantages of the present invention are not restricted by the exemplary embodiments of the present invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0039]      FIG. 1  shows a posterior view of an apparatus in accordance with an example embodiment of the present invention. 
           [0040]      FIG. 2  shows a posterior partial view of the apparatus of  FIG. 1 . 
           [0041]      FIG. 3  shows a cross-sectional view corresponding to section A-A of  FIG. 2 . 
           [0042]      FIG. 4  shows an anterior view of a vascular compression garment in accordance with an example embodiment of the present invention. 
           [0043]      FIG. 5  shows a cross-sectional view of an expandable bladder system in accordance with an example embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0044]    As to the figures, like reference characters indicate corresponding or like parts throughout the several figures. 
         [0045]      FIGS. 1 to 3  show a therapeutic apparatus in the form of a garment  100 . The garment  100  includes a torso section  200  connected to a pelvic section  300  having leg portions  315   a  and  315   b  adjacent a crotch region and configured to receive the patient&#39;s left and right legs respectively. The torso section  200  includes a plurality of elongated expandable bladders  210 , which, when the garment  100  is worn by a patient, longitudinally extend vertically or parallel to the anteroposterior axis of the patient. In the system of  FIG. 1 , the garment  100  includes four expandable bladders  210   a,    210   b,    210   c,    210   d,  with a first pair  210   a,    210   b  configured to underlie the patient&#39;s left scapula and a second pair  210   c,    210   d  configured to underlie the patient&#39;s right scapula. It should be understood, however, that any suitable number of bladders  210 , including a single bladder  210 , may be provided under each of the left scapula and the right scapula. 
         [0046]    A control unit  400  includes a pump mechanism  420  controlled by a processor  410  to selectably expand the bladders  210   a,    210   b,    210   c,    210   d.  The pump mechanism  420  may be, for example, the same as or like the pump described in the &#39;219 patent, which is described in greater detail above and which is incorporated by reference in its entirety by reference thereto. The control unit  400  is configured to control the expansion of each bladder  210   a ,  210   b,    210   c ,  210   d  independently to provide a highly controllable level of localized force at the location of each bladder  210   a ,  210   b ,  210   c ,  210   d.    
         [0047]    The processor  410  is programmed to expand bladders  210   a  and  210   b  while the bladders  210   c  and  210   d  are in a relatively deflated or non-expanded state, thus providing a rolling force that lifts the patient&#39;s back, in the area of the left scapula, to rotate the patient&#39;s torso rightward. Subsequently, the bladders  210   a  and  210   b  are deflated and the bladders  210   c  and  210   d  are expanded, so as to rotate the patient&#39;s torso leftward in an analogous manner. This process is repeated for any desired number of iterations or “rolls,” which may be predetermined and/or provided to the control unit  400  by an operator and/or the patient. Further, the rate of rolling and any amount of time between commencements of rolling treatment sessions (for example, every 10 to 20 minutes) may be predetermined and/or adjusted, for example, by the operator and/or patient. 
         [0048]      FIG. 1  shows that the garment  100  is integrated with components as described in the &#39;219 patent, which is discussed in greater detail above and which is incorporated herein in its entirety by reference thereto. For example, the garment  100  includes channels  335  and pressure relievers  346 , as described in the &#39;219 patent. These elements may be controlled, along with the bladders  400  and/or any other controllable components described herein, by the control unit  400  and/or a separate controller. 
         [0049]      FIG. 1  also shows that the garment  100  includes a soilage sensor  350  that is disposed in the groin region of the garment and that is configured to detect urinary and/or fecal soilage to alert, e.g., nurses, to the occurrence of urinary and/or fecal soilage. This signals the nurse to perform a garment change. The sensor may also allow the nurse to spend less time checking a patient for urinary and for fecal soilage. Although a single sensor  350  is shown, any number of sensors may be provided, as appropriate. The illustrated sensor is integrated into the garment and is associated with an alarm  450  disposed within the control unit  400 . The alarm may be provided at any suitable location, and it may be configured to receive signals using wired and/or wireless communication. 
         [0050]    Referring to  FIG. 3 , since the patient&#39;s back is generally angled with respect to the surface (e.g., the bed), supporting the patient&#39;s back during the respective right and left rolling movements, the outer bladders  210   a  and  210   d  hold a larger volume of pressurization fluid, or at least have a geometry that allows the bladders  210   a  and  210   d  to extend a greater distance between the patient&#39;s back and the surface on which the patient is lying. 
         [0051]    The control unit  400  may be integrated into the garment or provided as a separate unit, such as, for example, a hand-held device. Further, the processor  410  and the pump mechanism  420  may be provided in the same housing or separate housings and may communicate with each other through wired and/or wireless communication channels. 
         [0052]    The pump mechanism includes one or more pumps that are controllable to selectably pressurize and expand the bladders  210   a ,  210   b ,  210   c ,  210   d  via a pressurization fluid (e.g., a gas or liquid) that extends through pressure control lines and into the interior chambers of the bladders  210   a ,  210   b ,  210   c ,  210   d.    
         [0053]    In  FIG. 3 , each of the bladders  210   a ,  210   b ,  210   c ,  210   d  includes a respective vibrating and/or percussive device  220   a ,  220   b ,  220   c ,  220   d  disposed on the side of the respective bladder  210   a ,  210   b ,  210   c ,  210   d  adjacent the patient&#39;s back so as to improve pulmonary hygiene. The devices  220   a ,  220   b ,  220   c ,  220   d  create a vibratory and/or percussive effect to help mobilize sequestered secretions within the lungs of, e.g., debilitated and/or bed-ridden patients. Such vibratory and/or percussive treatments are intended to break up inspissated fluids within the lungs, reducing surface tension, so as to allow secretions to be mobilized and expectorated. This is intended to reduce the need for a nurse and for a pulmonary therapist to provide percussive treatment. Also, because the treatment mechanism is integrated into the garment, percussive therapy may be increased in frequency since it may be controlled in an automated manner. The vibrating and/or percussive devices  220   a ,  220   b ,  220   c ,  220   d  may be controlled, such as, for example, independently of each other, by the control unit  400  and/or a separate controller. 
         [0054]    Although the vibrating and percussive devices  220   a ,  220   b ,  220   c ,  220   d  are integrated into the bladders  210   a ,  210   b ,  210   c ,  210   d , the vibrating and/or percussive devices  220   a ,  220   b ,  220   c ,  220   d  may be provided separate from the bladders  210 . Further, multiple vibrating and/or percussive devices may be provided for each bladder  210   a ,  210   b ,  210   c , and/or  210   d.    
         [0055]    The vibrating and/or percussive devices  220   a ,  220   b ,  220   c ,  220   d  may apply mechanical percussion (for example, a cupping mechanism or paddle paddles that rotate back-and-forth) and/or ultrasonic vibration, which is intended to increase the effect of pulmonary surfactants. The vibrating and/or percussive devices  220   a ,  220   b ,  220   c ,  220   d  may be controlled (for example, by the controller  400 ) to provide vibration and/or percussion to the patients lungs simultaneously with the side-to-side “rolling” provided by the actuation of the bladders  210   a ,  210   b ,  210   c ,  210   d.    
         [0056]    Although “rolling” and vibration/percussion may be advantageous when applied alone or separately, it is believed that the simultaneously operable combination of a vibration/percussion mechanism and a “rolling” mechanism enhances the pulmonary benefits to the patient as compared to the application of these treatments applied alone or separately. 
         [0057]    Referring to  FIG. 4 , a vascular compression garment  500  is configured to be worn to surround around a patient&#39;s hip and upper thigh region in a manner similar to compression shorts. The garment  500  includes leg portions  515   a  and  515   b  configured to receive a patient&#39;s left and right legs, respectively. 
         [0058]    An expandable vascular compression bladder  510  is provided in the region of a vascular access and is controllable (for example, with controller  400  or a separate controller) in a manner like that of the control and pressurization of the bladders  210 , as described above. Although the bladder  510  is a single oval-shaped bladder, any number of bladders may be provided, and they may be separately controllable for applying pressure to the femoral artery. 
         [0059]    The garment  500  is configured to provide only enough pressure to minimize or at least reduce bleeding in connection with an invasive procedure, such as, for example, cardiac catheterization. The pressure bladder conforms to the patient&#39;s body and includes an integrated bleeding sensor  550  that triggers an alarm to alert nurses if bleeding occurs. The alarm mechanism may function in connection with a control unit (e.g., control unit  400 ), in a manner like that of the soilage sensor  350 , as described above. 
         [0060]    In response to the triggering of the alarm by the bleeding sensor  550 , a nurse may conduct manual intervention (including, for example, a visual inspection for bleeding) and/or the device may be controlled (for example, automatically) to increase the pressure applied to the vascular access region with the bladder  510 . 
         [0061]    The garment  500  may be integrated with the therapeutic garment  100  described above or provided as a separate and stand-alone apparatus. 
         [0062]    Furthermore, the garment  500  may be integrated into a larger garment that limits shifting so that pressure is only placed where it is anatomically needed. This larger garment may be, e.g., the therapeutic garment  100 , as described above. 
         [0063]    Further, although the garment  500  is configured to apply pressure to the femoral artery (for example, after an angiography procedure), the garment  500  may be configured to apply pressure to any appropriate access location in connection with any suitable procedure. 
         [0064]      FIG. 5  shows a system that includes a semi-permeable material  812  in the region of an expandable bladder  815  that is in approximation with a patient  900  supported on a bed  950 . A pump  820  (which may be the same as pump  420  shown in  FIG. 1 ) is controlled to supply air (or any other suitable gas), via supply line  822 , to the interior space  815  of the bladder  815 . The pressurization of the interior space  815  with respect to the ambient atmosphere creates a pressure differential across the semi-permeable material  812 . This pressure differential causes the air or other gas to pass (relatively slowly) across the semi-permeable material  812  and into contact with the patient&#39;s skin or a material adjacent the patient&#39;s skin. The air or gas provided to the patient  900  across the semi-permeable material is intended to control the temperature and humidity at the patient&#39;s skin and to help reduce and evaporate perspiration or other moisture. 
         [0065]    A controller (for example, controller  400  shown in  FIG. 1 ) may monitor the pressure the in the bladder  810  and provide additional gas to the bladder  810  to account for the gas passing through the semi-permeable material  812 . The control system may use a suitable pressure detection mechanism (for example, a pressure sensor) to maintain a desired pressure. 
         [0066]    In addition to controlling gas pressure in the bladder  812 , the temperature and/or humidity of the gas provided to the bladders  210   a ,  210   b ,  210   c ,  210   d  may be controlled. For example, the gas (e.g., air) may be cooled and dehumidified with respect to ambient air such that the gas passing though the semi-permeable material and into contact with the patient may be better suited to reduce moisture and perspiration and increase patient comfort. 
         [0067]    It is believed that the system of  FIG. 5  further resists development of pressure sores and increases patient comfort. The humidity and temperature of the air provided to the bladder  810  may be monitored (for example, by temperature and humidity sensors) and controlled accordingly. This monitoring may be performed, for example, at a gas supply source (for example, the pump  820 ) and/or within the bladder  810 . However, the gas may be cooled and/or dehumidified without sensing the temperature and humidity of the gas (for example, to simply the system and control thereof). 
         [0068]    As explained above, the system of  FIG. 5  may be used with any expandable bladder system described herein, including, for example, the expandable bladders  210   a ,  210   b ,  210   c ,  210   d , the components as described in the &#39;219 patent, (such as channels  335  and pressure relievers  346  shown in  FIG. 1 ), and/or the vascular compression bladder  510 . 
         [0069]    Although the present invention has been described with reference to particular examples and exemplary embodiments, the foregoing description is not limiting. Moreover, the apparatus, method, and system described herein may be used in any appropriate combination.

Technology Category: a