This application claims priority to provisional application 61 /544,175 filed October 6, 201 1 , which is incorporated herein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

None

BACKGROUND OF THE INVENTION

This disclosure relates to a portable article including a device and method for administrating therapy to a user. While the disclosure is directed specifically to treating impaired airway clearance for users or patients suffering from a variety of medical conditions that the effect lung function of the patient, those skilled in the art will recognize the wider applicability of the inventive principles discussed hereinafter.

Medical conditions that would benefit from improved lung drainage and more effective airway clearance include Cystic Fibrosis, Bronchiectasis, Pneumonia, and all other COPD (Chronic Obstructive Pulmonary Disease), for example. Airway clearance is the elimination of excess mucus and contaminants from the lungs. Natural airway clearance is accomplished when certain body mechanisms interact effectively. Mucus is secreted to entrap harmful substances and keep airways clean; natural filters such as nasal hairs help capture contaminants; cilia continuously sweep mucus from the lower segments of the lungs to upper airways; and coughing and sneezing clears the mucus from the respiratory system.

Natural airway clearance is extremely important because the process helps people stay healthy and breather easier, Mucus that accumulate in the lungs may lead to very serious complications including death. Excessive or retained mucus creates an ideal environment for the growth of infection-causing pathogens. These infections can damage healthy lung tissue and make breathing more difficult.

The assignee of the present disclosure has had a long history in providing treatment for impaired airway clearance. Various commercial products were and are sold under its well-known trademarks, including merely by way of example and not of limitation, Flimm Fighter ^® , Directional-Stroking ^® , Neo-Cussor™, VibraCare ^® , Therassist ^® , and Medatilt. For years, patients with impaired airway clearance relied upon manual chest physical therapy (CPT). Products employing the Directional-Stroking® method are particularly effective for airway clearance. However, while these and other associated products work well for their intended purpose, they often are not easily adapted for self administration. That is to say, a second person (care giver) is needed for use with the product or products in conjunction with the therapy being applied to the patient. As indicated above, products employing the Directional-Stroking ^® technique are particularly effective in loosening and moving contaminants and mucus from the lungs, for example, to the larger airways (i.e. thorax), where they can be coughed out.

A series of products are known in the art which employ what their manufacturers refer to as high frequency chest wall oscillation techniques, most of which use a vest or wrap which is worn by the patient. An air compressor and at least one associated hose are connected from the air compressor to the vest or wrap. In operation, the air compressor must be continuously-connected to a 120 volt or 220 volt electrical power source throughout the full period of each treatment. While those products claim to be portable, all require an external bulky and noisy air compressor and connecting hose extending from the compressor to the vest or wrap, and an available connection to a 120 volt or 220 volt power source. The competitive systems are portable only in the analogous sense that the original portable compressors, weighing approximately fifteen pounds, were portable compressors. The vest and compressors can be lugged around, but they truly are not portable as that term has become to be understood in the art or by the consuming public.

As disclosed below, a completely safe, truly portable, self-contained, easy- to-use article is provided for unattended use by both children and adults. The article, sometimes referred to herein after as a G5 ^® Freedom™ system, in one illustrative embodiment, includes a vest or wrap made operational by the provision of a plurality of recessed pockets and/or attachment provisions on or in the article positioned adjacent to the major lung segments, both topical and apical when the article is worn by the patient. The pockets or attachment provisions hold at least one self-contained power module or power pod adapted to provide the "Direction Stoking" forces to the patient without the need for an attendant or caregiver for the patient. As will be appreciated by those skilled in the art, the number of potential embodiments employing the inventive constructions disclosed hereinafter is limited only by one's imagination.

BRIEF SUMMARY OF THE INVENTION

In accordance with this disclosure, generally stated, a simplified, portable article is provided for administrating air way clearance therapy, for example, by the application of selective-segment, sequentially-synchronized percussive Directional Stroking force to the patient. In one preferred embodiment, the article includes a specialized vest which is worn by a patient during therapy. This vest has a plurality of pockets formed in it, each of which are sized to receive a power pod, placing the pods in close proximity to areas of the patient's body requiring therapy. The power pods are designed to provide therapy to the patient. An electronic controller enables the therapist or patient to select and control the manner in which each individual power pod is energized, and at what frequency, in which sequence, and at which specific location on the patient.

One feature of the disclosure is the ability to provide selective energy adjustment using a low voltage twelve volt power source, which even when combined with various forms of the article offers a low weight system when compared to other available therapeutic devices designed for similar purposes.

Another feature of the disclosure is the ability to provide an article which can be constructed to permit proper orientation of the power pods so as to apply the desired therapy at the specific location on a patient, for example, when using the article.

Another feature of the disclosure is the preferred construction of power pods for a particular article in which the enclosure of the power pods transmits the force to the patient

Yet another feature of the disclosure is that once the article is place on a patient, the treatment provides for hands free operation.

Another feature of the disclosure is the provision of a power pod construction which can be operated from a variety of power sources, including for example battery operation and/or air while the operation of any part of the article utilizing the power pod remains therapeutically consistent.

Other features of the disclosure will be apparent to those skilled in the art in view of the following description and accompanying drawings.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

In the accompanying drawings which form part of the specification:

FIG. 1 is a diagrammatic view of one illustrative embodiment of article of the present disclosure;

FIG. 1 B is a diagrammatic view of a second illustrative embodiment, partly broken away, of the article show in FIG. 1

FIG. 2 is a diagrammatic view showing the human lungs with which the embodiment of FIG. 1 finds application;

FIG. 3 is a diagrammatic view of the embodiment of FIG. 1 showing one illustrative arrangement of a connection diagram for a plurality of power pods employed with the embodiment of FIG. 1 . FIG. 4 is a top plan view of one illustrative embodiment for control device shown in FIG: 1 .

FIG 5A - 5D views of a second illustrative embodiment of article of the present disclosure;

FIG. 6 is a view in perspective, partly broken away, of the outward facing side of article shown in FIG. 1 ;

FIG. 7 is a view in perspective of the inward patient facing side of the article shown in FIG.1 ;

FIG. 8 is an enlarged view in perspective, partly broken away taken about the line 8-8 in FIG. 7, illustrating the power pod holder and one illustrative attachment method for the power pod;

FIG. 9A is a top plan view of one illustrative embodiment of power pod employed with the embodiments of FIG. 7 and 5;

FIG.9B is an end view of the power pod shown in FIG 9A

FIG.9C is a sectional view taken along the line 9C of FIG 9A

FIG.9D is a sectional view taken along the line 9D of FIG 9A;

FIG.1 OA is an end view of an eccentric employed with the power pod of FIG. 9; and

FIG.1 OB is a side view of the eccentric shown in FIG. 10A.

Corresponding reference numerals indicate corresponding parts throughout the several figures of the drawings.

DESCRIPTION OF THE PREFERRED EMBODIMENT

The following detailed description illustrates the article for which Letters Patent is sought by way of example and not by way of limitation. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what I presently believe is the best mode of carrying out the invention. Referring now to Figure 1 , reference numeral 1 indicates one illustrative article of the present disclosure in one of its preferred forms. The embodiment of Figure 1 , illustrates a device 3 in the form of a vest 22 worn by a user, as later described in greater detail. The vest 22 is operatively connected through a connector 5 to a control panel 7. The control panel 7 has a first input side operatively connected to a controller 9 and a second input operably connected to a power source 15 through a suitable source of power, which in the embodiment is a low voltage power supply 1 1 and a connector 13.

The power source 15 preferably is a source of 120 - 220 volt electrical energy commonly obtained at a conventional electrical plug connected to the power grid. The power supply 1 1 reduces the electrical energy from the power source 15 to a low level electrical source for the control panel 7.

As will be appreciated by those skilled in the art, while Figure 1 describes one source of electrical energy for operation of the device 1 , the power source 15 may be replaced by a battery source of energy 17 without altering other components of the device 1 . A battery power source is shown in Figure 1 B. As can be further appreciated by those skilled in the art, while some form of electrical operation is preferred, the design also can be easily converted to accommodate an air powered source of energy in the form of a suitable air compressor. I have found, however, electrically energized forms of the article 1 are preferred in application use.

As is best seen in Figure 7, the article 1 , preferably in the vest 22 form, includes a first part 23 and a second part 24. The vest 22 may assume a variety of configurations and designs. In the embodiment shown, the parts 23 and 24 are sized to cover the back and chest of the intended user and define a central head opening 25. The parts 23 and 24 of the vest 22 are shown in diagrammatic form in Figure 3. As shown, the connector 5 is operatively associated with a circuit 20 which is arranged on or about the parts 23 and 24 so as to interconnect a plurality of power pods 19 carried by the parts 23 and 24. The particular location of the power pods 19 with respect to the vest 22 is an important consideration. In the embodiment shown in Figure 3, for example, the power pod 19 locations are selected to overlay the lungs of a user on both of the chest and back sides of the user. Placement of the power pods 19 with respect to the lungs is illustratively shown in Figure 2 and, as later described in greater detail, the power pods 19 operating to provide drainage of fluids from the lungs of a user so that the fluids can be naturally expelled by the user.

Referring now to Figure 8, the power pods 19 are mounted within a pocket 29 formed integrally with a cover part 31 . In the embodiment illustrated, the cover part 31 includes hook and loop fastening material 33 positioned along a longitudinal axis of the pocket part 29 and along the edges of the cover part 31 . Corresponding hook and loop material 34 is positioned about the mouth of a cavity 35 formed in the articlel , and along a bottom wall 45 of the cavity 35. The number of cavities required is a matter of design choice. In the preferred embodiment illustrated, four cavities 35 are formed in each of the parts 23 and 24 of the vest 22. Figure 8 illustrates the pocket 29 removed from a cavity 35, while Figure 7 shows a cover part 31 in position or in their respective cavities in the closed and operating position of the cover part 31 . Those skilled in the art will recognize that other methods of attachment and placement of the power pods 19 are compatible the broader aspects of the disclosure.

Figure 6 illustrates the vest 22 attached to a user of the device 1 . Preferably the vest 22 is worn by and attached to the user through the use of conventional strap 41 and snap buckles 38. As shown in Figure 6, a pair of strap 41 and buckle 41 combinations function to attach the vest parts 23 and 24 of the vest 22 over the shoulders of the user. Similarly, the vest 22 also attaches to a user's torso in the embodiment shown in Figure 6 and the parts 23 and 24 are maintained in position by an arrangement of strap 39 and buckle 38 combinations. Other methods of attachment will be apparent to those skilled in the art.

The buckles 38 and strap 41 combination along the top of the vest parts 23 and 24 , referenced to Figure 6 act as shoulder straps and serve a practical function besides connecting the parts 23 and 24 of the vest 22. I have found that use of the shoulder straps 41 allows the vest 22 to accommodate a variety of torso lengths for any particularly user, while the straps 39 and buckles 38 likewise can accommodate a variety of different physical configurations of the intended user so that one particular configuration of the vest 22 will accommodate users having a variety of physical body configurations. Those skilled in the art, of course, will recognize that the vest 22 may have a one piece construction if, desired.

One illustrative embodiment of the controller 9 compatible with the vest 22 is shown in Figure 4. As there shown, various operating configurations possible with article 1 of the present disclosure are shown in a general configuration. The controller 9 is intended to be programmable to offer a number of operational modes as later described in greater detail. Those skilled in the art will recognize that the controller 9 can assume a variety of design configurations and provide any number of operational modes for the vest 22.

Figures 9 a through 9 d show one illustrative embodiment of the power pods 19 employed with the article 1 . Each of the power pods 19 includes a housing 50 preferably constructed in two parts. The housing 50 has a connection end 51 operatively connecting the power pods 19 to the circuit 20. Each power pod 19 includes an electrical motor 53 having a connection 54 and an output shaft 52. The shaft 52 is mounted for rotation within the housing 50 along bearing structures 58 and 59 . An eccentric 60 is mounted to the shaft 52 and rotates when the motor 53 is operated under the control of the controller 9. Rotation of the eccentric 60 generates a directional stroking force through the housing 50 to the body of the intended user. As indicated herein, this is an important feature of the article 1 in general and the vest 22 in particular in that the power pods19 themselves provide a therapeutic action for the vest 22 without outside assistance in the way or need for additional adapters, connectors or applicator devices generally require by the prior art. The eccentric 60 is specifically designed for mounting on the shaft 52 along an internal opening 62 through the use of conventional fasteners used to attach the eccentric 60 to the shaft 52 through an opening 64 in the body of the eccentric 60.

While the power pods 19 find specific application in conjunction with the vest 22, because of the unique design of the power pods, other physiotherapy applications are easily adaptable to their use. Merely by way of example, Figures 5 a through 5 d illustrate a therapeutic wrap 72 which may be placed on various extremities of a user for various therapy applications. As shown in figure 5 b, the wrap 72 has an application side 74 having a plurality of pockets 29 having a construction similar to the pockets 29 of the vest 22. Preferably hook and loop fasteners permit wrap 72 attachment to areas requiring application therapy. Again, other connection or fastening methods are contemplated by this disclosure.

Operation of the article of this disclosure is relatively simple to understand. In the preferred embodiment, the multi-pocketed vest 22 incorporates eight power pods 19, four at the lower lobe of each lung, one on each side of a patient's body; and, four at the upper lobe of each lung, one on each side of a patient's body, with each of the eight power pods 1 9 positioned so that the Directional Stroking® action of each of the power pods 19 is directed toward the patient's thorax. All eight of the power pods 19 are powered by an external 120 volt or 220 volt power source, reduced down to 12 or 24 volts, or can be individually powered by a single 12 volt or 9 volt battery pack which is maybe, for example carried in a pocket in the vest 22, for complete portability (or, alternatively, each power pod 19 can be independently powered by a 9 volt or 24 volt battery attached to or within the body of vest 22). The patient or therapist then activates the hand-held, electronic control module or controller 9 which sequentially-activates the four lower-lobe power pods 19, all synchronized to provide Directional Stroking® percussion to the patient's lower lung lobes, at identical, slow frequencies of 20 cycles per second (CPS). After a pre-selected time (depending on the physical size of the patient), the controller 9 then automatically activates the remaining four upper-lobe power pods 19, to provide Directional Stroking® percussion to the patient's two upper lobes, with all upper- lobe power pods 19 synchronized at a slightly-higher frequency of 30 CPS, to assist in mobilizing mucus toward the patient's thorax, where it can be coughed up. It should be noted that the higher vibratory frequency also stimulates the patient's cough mechanism in the patient's throat, thereby assisting in the elimination of damaging mucus and other fluids from the lungs of the patient.

Alternative uses of the selective-segmented, sequentially-synchronized operation of the vest 22 include uses for massage purposes and/or for lymphatic drainage, for example. By wrapping the vest 22 (or a special article 1 ) around the leg of a patient, (See Fig. 5) for deep-tissue massage, for sequentially- synchronized massage from a patient's lower leg, upward toward a patient's hip - or from a patient's lower back, upward toward a patient's shoulders.

Other programs for controller 9 operation will be apparent to those skilled in the art. In addition, while the controller 9 is shown as being hard wired to the control panel 7, it is apparent that other forms of communication not requiring a physical connection are within the scope of the appended claims. Advances in both communication forms and electronic device advances may permit the elimination of the control panel completely, or may allow the distribution of the panel 7 functions directly to the power pod 19. These variations are merely illustrative. As various changes could be made in the above constructions without departing from the scope of the invention, it is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

In view of the above, it will be seen that the several objects and advantages of the present invention have been achieved and other advantageous results have been obtained.