Abstract:
A portable, handheld device for manual percussive respiratory therapy in infants and young children having a pear-shaped dome for proper position of the device over various sizes of target treatment anatomy, an ergonomic handle for maximum efficacy in implementation by a range of users, a cushioned sealing mechanism for softening the impact on a young patient, and indicator means to indicate proper positioning and engagement of the device during use. The device is optimal for use by parents and other caregivers with little or no medical training.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority to a provisional U.S. patent application entitled, “Cough Assistance, Airway Clearance Device”, filed Oct. 6, 2006, having a Ser. No. 60/849,944, the disclosure of which is hereby incorporated by reference in its entirety. 
     
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to an apparatus and method directed to the treatment of respiratory congestion in infants and young children due to the accumulation of mucus in the bronchioles from various viruses and diseases. More particularly, the present invention relates to an ergonomic, portable, hand-held, and pliable device configured to non-injuriously and effectively clear the airways of infants and young children through accurate positioning and coverage over the target treatment areas. 
       BACKGROUND OF THE INVENTION 
       [0003]    This disclosure relates to the treatment of respiratory congestion in infants and young children due to bronchiolitis and similar viruses and diseases, such as cystic fibrosis, that cause accumulation of mucus in the bronchioles (air passages leading to the lungs) and in the lungs. This invention utilizes the principles of chest physiotherapy, whereby body positioning and percussive force are applied to the chest using a cupped hand to move mucus and to stimulate coughing to clear a patient&#39;s airways. Accordingly, this invention is a hand-held pear and dome-shaped device, made of highly-pliable material for curving around the ribcage, thereby enabling effective movement of mucus to assist in airway clearance. 
         [0004]    Bronchiolitis, often caused by the Respiratory Syncytial Virus (RSV), is one of the leading causes of the need for urgent medical treatment in infants and young children. For these small patients, there is little medical assistance that can be provided other than aspirating the nasal passages to relieve congestion, and ensuring that the child is receiving sufficient fluids and oxygen. Traditional chest physiotherapy is sometimes used, however, this technique is not well understood by parents and is not always embraced, as the treatment requires some force on the child&#39;s lungs and body to relieve congestion and clear the airways. 
         [0005]    There are a number of different devices and designs that employ the principles of chest physiotherapy and pulmonary percussion to help dislodge and loosen secretions and/or mucus from the lungs and chest. Early methods and devices to treat conditions and diseases such as bronchiolitis and cystic fibrosis implemented chest physiotherapy and percussion for the reduction and removal of accumulated mucus. Such methods and devices were often primitive and were applied with great physical force to achieve optimal efficacy, resulting in unwarranted physical injury to the patient undergoing treatment. 
         [0006]    U.S. Pat. No. 4,429,688 (the &#39;688 patent) issued to Duffy is an exemplary application of such early forms of percussive therapy. This device is a hand-held manual percussive instrument. It is circular in shape and provides a knob handle to assist in gripping the device for delivering chest physiotherapy. This instrument incorporates a compressible gaseous vapor within the cavity of the device to cushion the skin from the compressive forces of the instrument. An embodiment of the device resembles a plunger and requires the user to drive an attached shaft into the percussive instrument to deliver force to the target treatment region. The large contact area of this apparatus and similar devices made them unsuitable for the treatment of infants and young children whose soft bones and delicate skin rendered them susceptible to significant injury from repetitive engagement of the device. 
         [0007]    Moreover, the oversized contact area made proper positioning over the desired treatment area of a young patient unlikely, if not impossible. The plunger-like embodiment of the &#39;688 patent also possessed the potential to cause horrific injury to infants and children due to the massive downward energy created through the powerful push of the shaft to the main body of the percussor device. 
         [0008]    U.S. Pat. No. 4,196,722 (the &#39;722 patent) issued to Vanderwoude for “Percussion Instrument Used in Respiratory Therapy” discloses a hand-held manually operated percussive instrument for chest physiotherapy in the form of a percussor cup with a rounded high bell shape. The therapist or caregiver would tightly grip the top end of the dome with his or her fingers and would swing the cup, while gaining momentum through the air in a single stroke to land with a strike against the patient&#39;s target treatment air. The bell shape of the percussor cup provides limited means for accuracy over the target area on a young patient as there is no differential in size of the cup at the point of contact of the device with the patient&#39;s skin. Use of this device results in over-treating the patient as the target and surrounding unaffected area are repeatedly treated causing ineffective treatment of the suffering area and possible inflammation of the unaffected surrounding area, which may or may not be able to withstand the repetitive compression effects of the device. 
         [0009]    U.S. Pat. No. 4,745,910 to Day et al., issued in 1988, is directed to a percussor and methods to aid in the removal of lung secretions. As early as 1980, as evidenced in the disclosure of the &#39;722 patent, persons of ordinary skill in the art were aware that an apparatus that required significant forearm movement caused momentous forces harmful to young patients Nevertheless, the Day percussor seeks to remove undesired lung secretion accumulation in infants and young children via the utilization of a hammer-like handle and a bell-shaped percussor at the end of the handle. This apparatus did not address the long-felt need for improvement in gentler, non-injurious administration of chest physiotherapy on infants and children. Rather, it achieved only a modification of the then-traditional percussor cup to gain a slight advantage over previous devices in the size of percussor cup used. 
         [0010]    These prior art devices require full grasping and significant involvement of the arm to deliver the percussive therapy, and present a number of problems during implementation on a young patient such as an infant or a child. Subsequent devices invented over the past twenty years, such as those disclosed in U.S. Pat. Nos. 5,261,394, 5,606,754, 6,098,222, 6,290,660, and 7,232,417, incorporate traditional chest physiotherapy along with vibration and acoustic technology. These devices did not solve the need for improvement of the percussor devices set forth above, but sought to reduce chest and lung bronchiole congestion through new vibration and acoustic methods. These new therapies functioned via increasingly complex mechanical and electronic devices, which are not befitting for implementation by a parent or other caregiver with little or no medical training. 
         [0011]    The vibration and acoustic technologies were also ill-equipped to solve the need for a device directed to the treatment of an infant or young child. These technologies are ill-suited for use on infants and young children, who are generally unable to breathe forcefully into these devices and exhale against an escalating incoming air flow in an attempt to loosen accumulated mucus. The vibration technology itself is extremely dangerous for use on infants as their bones and surrounding supportive tissue and cartilage are neither solidified nor are strong enough to withstand the vibration forces of these devices. 
         [0012]    Accordingly, the invention disclosed herein provides parents and caregivers with a gentler, hand-held device to administer chest physiotherapy to clear the airways. Unlike other instruments, this device uses highly pliable material to reach the air passages more effectively. It provides a unique handle to enable a number of gripping options. The base of the dome is cushioned to protect the skin from irritation by creating an air pocket of protection. The shape of the dome enables treatment to reach the large and small portions of the lobes of the lungs. The device may be configured in a number of sizes to facilitate the most effective treatment. 
         [0013]    Accordingly, it is an object of the invention to provide a simple percussive therapy device that is easily utilized by a novice, parent, or other caregiver on an infant or young child without the need for intensive medical training. 
         [0014]    Another object of the invention is to provide for the greatest flexibility in hand and wrist movement. 
         [0015]    It is further an object to provide an alternative treatment means for administering chest physiotherapy to small areas of a young patient&#39;s anatomy. 
         [0016]    Another object of the invention is to provide an indicator to signal proper compressive engagement of the invention with the patient&#39;s skin. 
         [0017]    Still another object of the invention is to provide a percussive therapy device that is utilized to convert accumulated mucus or phlegm solids into a viscous form that can be exited through the patient&#39;s respiratory or waste elimination systems. 
       SUMMARY OF THE INVENTION 
       [0018]    The foregoing needs are met, to a great extent, by the present invention, wherein in one aspect an apparatus is provided that in some embodiments comprises a portable, handheld device for manual percussive respiratory therapy. 
         [0019]    In accordance with one embodiment of the present invention, a portable, handheld device for manual percussive respiratory therapy is provided comprising a dome having a smaller proximal portion and a larger distal portion, an ergonomic handle accessible from an outer surface of the dome and having central and end portions wherein the central portion is contiguous and adjacent to each end portion such that each end portion meets the outer surface of the dome, and further wherein a width of the handle expands gradually from the central portion towards the end portions, and a compressive area about the dome wherein a base of the compressive area is surrounded by a cushioned air sealing mechanism having a smaller proximal portion and a larger distal portion for fitted engagement with the dome. 
         [0020]    In accordance with another embodiment of the present invention, a portable, handheld device for manual percussive respiratory therapy is provided comprising a dome having a smaller proximal portion and a larger distal portion, an ergonomic handle accessible from an outer surface of the dome and having central and end portions wherein the central portion is contiguous and adjacent to each end portion such that each end portion meets the outer surface of the dome, and further wherein a width of the handle expands gradually from the central portion towards the end portions, a compressive area about the dome wherein a base of the compressive area is surrounded by a cushioned air sealing mechanism having a smaller proximal portion and a larger distal portion for fitted engagement with the dome and further wherein the cushioned air sealing mechanism is removably attached to the base of the compressive area, and indicator means within the dome to indicate proper positioning and compression of the device during implementation. 
         [0021]    In accordance with an additional embodiment of the present invention, a portable, handheld device for manual percussive respiratory therapy in infants and young children is provided comprising a dome having a smaller proximal portion and a larger distal portion such that the proximal and distal portions are applied respectively to appropriately sized treatment areas of an infant or child patient, an ergonomic handle accessible from an outer surface of the dome and having central and end portions wherein the central portion is contiguous and adjacent to each end portion such that each end portion meets the outer surface of the dome and further wherein a width of the handle expands gradually from the central portion towards the end portions, compressive area about the dome herein a base of the compressive area is surrounded by a cushioned air sealing mechanism having a smaller proximal portion and a larger distal portion for fitted engagement with the dome and further wherein the cushioned air sealing mechanism is removably attached to the base of the compressive area, a plurality of compression coils positioned within the cushioned air sealing mechanism for maximum sealing efficacy; and indicator means within the dome to indicate proper positioning and compression of the device during implementation. 
         [0022]    In accordance with another embodiment of the present invention, a portable, handheld device for manual percussive respiratory therapy is provided with a dome having a smaller proximal portion and a larger distal portion, a plurality of ergonomic handles accessible from an outer surface of the dome wherein a width of the handles expands gradually from an end of each handle to a base of each handle, a compressive area about the dome wherein a base of the compressive area is surrounded by a cushioned air sealing mechanism having a smaller proximal portion and a larger distal portion for fitted engagement with the dome and further wherein the cushioned air sealing mechanism is removably attached to the base of the compressive area; and indicator means within the dome to indicate proper positioning and compression of the device during implementation. 
         [0023]    There has thus been outlined, rather broadly, certain embodiments of the invention in order that the detailed description thereof herein may be better understood, and in order that the present contribution to the art may be better appreciated. There are, of course, additional embodiments of the invention that will be described below and which will form the subject matter of the claims appended hereto. 
         [0024]    In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of embodiments in addition to those described and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein, as well as the abstract, are for the purpose of description and should not be regarded as limiting. 
         [0025]    As such, those skilled in the art will appreciate that the conception upon which this disclosure is based may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention. 
     
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0026]      FIG. 1  is a perspective view illustrating a top view of a manual respiratory device according to a preferred embodiment of the invention. 
           [0027]      FIG. 2  is a perspective view illustrating the device shown  FIG. 1 , showing the handle and dome isometrically according to a first aspect of a preferred embodiment of the invention. 
           [0028]      FIG. 3  is a perspective view of a cross section through section A-A of  FIG. 1  according to a first aspect of a preferred embodiment of the invention. 
           [0029]      FIG. 4  is a cross section through a section perpendicular to that of  FIG. 3  according to a preferred embodiment of the present invention. 
           [0030]      FIG. 5  is a perspective view illustrating the interior of the dome according to a preferred embodiment of the invention. 
           [0031]      FIG. 6  is a photograph of an exemplary prototype of the manual respiratory device according to a second embodiment of the invention. 
           [0032]      FIG. 7  is a perspective view of a manual respiratory device according to a third embodiment of the invention. 
           [0033]      FIG. 8  is a side view illustrating the device shown  FIG. 8 , according to a first aspect of a third embodiment of the invention. 
           [0034]      FIG. 9  is a perspective view of the back of the distal portion of the device according to a first aspect of a third embodiment of the invention. 
           [0035]      FIG. 10  is a top view of a device according to a third embodiment of the present invention. 
           [0036]      FIG. 11  is a cross section through a section perpendicular to that of  FIG. 10  according to a third embodiment of the present invention. 
           [0037]      FIG. 12A  is a first exemplary view illustrating a side of the device according to a first aspect of a fourth embodiment of the invention. 
           [0038]      FIG. 12B  is a second exemplary view illustrating a side of the device according to a first aspect of a fourth embodiment of the invention. 
           [0039]      FIG. 13A  is a perspective view illustrating the distal portion of the device according to a first aspect of a fifth embodiment of the invention. 
           [0040]      FIG. 13B  is an exemplary side view of the device according to a first aspect of a fifth embodiment of the invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0041]    The invention will now be described with reference to the drawing figures, in which like reference numerals refer to like parts throughout. An embodiment of the present inventive apparatus and method for the use of the inventive apparatus is illustrated in  FIG. 1 . Referring now to  FIG. 1 , therein depicted is a manual respiratory device  10  provided for use in aiding airway clearance according to a preferred embodiment of the present invention. Device  10  has a dome having an outer shell  12  and an inner shell  28 . The dome is manufactured with injection molding methods and a shape retaining synthetic resinous material, such as Acrylonitrile Butadiene Styrene (ABS). 
         [0042]    In a first embodiment of the present invention, a handle  14  of substantially uniform relative wall thickness is attached to the dome. The handle  14  varies in width from the central horizontal cross section  16 , taken along line A-A and viewable in  FIG. 1 , to ends  18  and  20  that contact the dome. This provides an expanding contact surface area along the handle  14  so that a variety of users can use the inventive apparatus optimally. Users with smaller hands can position their hands along the central portion of the handle  14  for maximum effectiveness. Users with larger hands do not need to grip the handle  14  tightly as placement on the expanding contact areas towards ends  18  and  20  will allow these users to maintain a natural hold on the handle during implementation of the apparatus. The handle  14  provides a method by which the device  10  may be used in a most effective way, by sliding a user&#39;s fingers around the handle  14  to provide for the greatest flexibility in palm and wrist movement. There is no grasping required, therefore the full motion of the user&#39;s hand is available to deliver percussive therapy. 
         [0043]    The dome is configured in the form of a pear wherein the proximal portion  22  of the dome has a radius smaller than that of the central portion of the dome to allow for better contact with the smaller lobes of the lungs and to better assist in flexing around the rib cage of patients. The distal portion  24  of the dome has a radius greater than that of the central portion of the dome. Application of the distal portion  24  of the dome to the patient allows for treatment of a larger surface area when desired. The ability to alternate from the smaller proximal portion  22  to the greater distal portion  24  not only allows for variance in treatment surface area, but also provides options for a range in the number of repetitive applications of the treatment to desired target areas. 
         [0044]    Due to the reduced size of the smaller proximal portion  22 , lessened and gentler compression forces are applied to the young patient when using this segment, and thus may be applied with greater repetitions without the risk of injury, if such repetitions are necessary to obtain optimal dispersion of the lung or chest congestion. Similarly, application of the larger distal portion  24  may require lesser repetitions during treatment as a larger target area is impacted with each compression application. 
         [0045]    The base of the dome meets the compressive area  26  of the device  10  that contacts the patient&#39;s chest or other desired target treatment area. A side view of the compressive area  26  is depicted in  FIG. 2 .  FIGS. 3 through 6  illustrate varying perspective views of the compressive area  26  to demonstrate the features within. A pictorial of a frontal view of compressive area  26  is illustrated in  FIG. 5  and consists of an annular loop or hollow ring  28  The loop or ring  28  is formed through injection molding methods, and is a latex or similar soft synthetic rubber material that is highly yieldable, resilient, and wear-resistant. The loop or ring  28  is cushioned and compressible to absorb the impact force as the device  10  is placed on the patient&#39;s skin and to provide a soft and non-abrasive contact area for the device  10 . 
         [0046]      FIG. 3  shows a perspective view of a cross section through line A-A  16  of  FIG. 1 . In the proximal portion  22  and distal portion  24 , compression coils  38  and  40  are placed within the loop or ring  28 . When the device  10  is engaged with a patient&#39;s skin, the cushion of loop or ring  28  compresses to soften the impact of the device  10  against the skin. The compression coils  38  and  40 , which are made of a material slightly denser than that of loop or ring  28 , resist full compression of the loop in the surrounding region to create an air-tight seal between the device  10  and the patient&#39;s skin. 
         [0047]      FIG. 4  is a cross section through a section perpendicular to that of  FIG. 3  according to a preferred embodiment of the present invention. Therein, at least one compression coil  40  is viewable on the left and right segments of the device  10 . 
         [0048]      FIG. 5  is a perspective view illustrating the interior  30  of the dome according to a preferred embodiment of the invention. The annular loop or ring  28  is viewable such that it extends in a three-dimensional manner to illustrate its cushioned properties. 
         [0049]      FIG. 6  is a photograph of a physical model of the manual respiratory device according to a second embodiment of the invention. The photograph shows the annular loop or ring  28  as removably attached to the compressive area  26  of the device. The attachable loop or ring is configured similarly to the compressive area  26 , in that it has a smaller proximal portion  32  and a larger distal portion  34  to fit the dimensions of compression area  26 . The rim  34  allows the loop or ring  28  to fit tightly over the compression area  26  so as to remain fully attached during implementation of the device  10 . 
         [0050]    In a third embodiment of the present invention, and with reference to  FIG. 7 , a manual respiratory device  10 ′ is provided with a left handle  42  and a right handle  44  attached to a flat portion of the outer shell  12  of the dome. The ergonomic handles  42  and  44  are curved and vary in width from the end of the handles to the base  46 . The end of the handles  42  and  44  form the narrowest portion, as the width increases gradually towards the base  46 . A side view of the device according to this embodiment is illustrated in  FIG. 8 .  FIG. 8  shows handle  42 , wherein an inner surface  48  is viewable. The side view is exemplary of the increasing handle width from the end of the handle to the base  46 . 
         [0051]    The expanding contact surface areas along the handles  42  and  44  are provided so that a variety of users can use the inventive apparatus optimally. Users with smaller hands can position their hands along the curve of handles  42  and  44  for maximum effectiveness. Users with larger hands do not need to grip the handles  42  and  44  tightly as placement on the expanding contact areas towards the bases  46  will allow these users to maintain a natural hold on the handle during implementation of the apparatus. The handles  42  and  44  provides a method by which the device  10 ′ may be used in a most effective way, by sliding a user&#39;s fingers around handles  42  and  44  to provide for the greatest flexibility in palm and wrist movement. There is no grasping required, therefore the full motion of the user&#39;s hand is available to deliver percussive therapy. 
         [0052]      FIG. 9  shows a perspective view of the distal portion  24  of the device wherein the inner surfaces  48  and  50  of the handles  42  and  44  are shown respectively. A top view of the device according to a third embodiment of the invention is presented in  FIG. 10 , wherein a line A-A representing cross section  52  is shown.  FIG. 11  shows a view along the cross section  52  wherein the outer surface of the right handle  44  is shown. 
         [0053]    A fourth embodiment of the inventive apparatus is shown in  FIGS. 12A and 12B  wherein a light emitting diode (LED)  54  is embedded into the outer shell  12  of a dome of a manual respiratory device  10 ″. The LED  54  is initiated by way of connecting with a strain gauge that is implanted into the inner surface  28  of the shell. When the device is used, a strain is placed on the dome. Upon due strain through normal use, or minor deflection during normal use, the strain gauge detects the displacement and transmits a low voltage output. The low voltage output provides a signal to trigger the LED  54 , displaying a light within the diode to indicate to the user that there is sufficient pressure for effective treatment. The operation of an LED  54  is well known in the art. 
         [0054]      FIGS. 13A and 13B  illustrate a fifth embodiment of a manual respiratory device  10 ′″ according to the present invention. A pressure gradient indicator  56  is embedded in the outside shell  12  of the dome of the device. The pressure gradient indicator  56  is a material that changes color due to minor deflections in the main body of the dome. When sufficient pressure is placed upon the main body of the dome, a color change in the indicator  56  alerts the user that optimal pressure has been applied. The pressure gradient indicator  56  is located in the central portion of the outside shell  12  of the dome, has an approximate thickness of ½ inch, and winds around the circumference of the outer shell  12 . 
         [0055]    Although an example of the device  10 ,  10 ′,  10 ″, and  10 ′″ are shown using a loop or ring, it will be appreciated that other yieldable, sealing agents can be used. Also, although the device is useful for chest physiotherapy, it can also be used to do other things and/or in other industries. 
         [0056]    Many features and advantages of the invention are apparent from the detailed specification, and thus, it is intended by the appended claims to cover all such features and advantages of the invention which fall within the true spirit and scope of the invention. Further, since numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.