Abstract:
An air vest for supplying successive percussive forces to a patient during a therapy session is described. The air vest includes an air bladder and at least one belt for securing the vest to a patient, with the vest adapted to engage at least a portion of the thoracic region of the patient. The vest may define an inner surface, an outer surface, and one or more extension portions for controlling movement of the inner and outer surfaces relative to each other along at least a portion of the vest. Securement and fitting of the vest to the patient may be achieved with a plurality of releasable straps.

Description:
RELATED APPLICATIONS  
       [0001]    This application claims the benefit of U.S. Provisional Application Ser. No. 61/615,008, filed Mar. 23, 2012, which is incorporated by reference herein in its entirety. 
     
    
     TECHNICAL FIELD  
       [0002]    The present invention relates to oscillatory chest compression devices and more particularly to improved air vest devices for an air pulse system. 
       BACKGROUND OF THE INVENTION  
       [0003]    A variety of high frequency chest compression (“HFCC”) systems have been developed to aid in the clearance of mucus from the lung. Such systems typically involve the use of an air delivery device, in combination with a patient-worn vest. Such vests were developed for patients with cystic fibrosis, and are designed to provide airway clearance therapy. The inflatable vest is linked to an air pulse generator that provides air pulses to the vest during inspiration and/or expiration. The air pulses produce transient cephalad air flow bias spikes in the airways, which move mucous toward the larger airways where it can be cleared by coughing. The prior vest systems differ from each other, in at least one respect, by the valves they employ (if any), and in turn, by such features as their overall weight and the wave form of the air produced. 
       SUMMARY OF THE INVENTION  
       [0004]    The present invention is directed to an improved vest device for a chest compression apparatus for applying a force to the thoracic region of the patient. The force applying mechanism includes the vest for receiving pressurized air from a remote pulse generator. The apparatus further includes a mechanism for supplying pressure pulses of pressurized air to the vest. The pressure pulses may have various different waveforms, such as, but not limited to, a sinusoidal waveform, a triangular waveform, and a square wave form. The apparatus provides a variety of solutions and options to the treatment problem faced by people having cystic fibrosis. The advantages of the invention relate to benefits derived from a treatment program using the present apparatus rather than a conventional device having a rotary valve and corresponding pulses. In this regard, a treatment program with the present apparatus provides a cystic fibrosis patient with independence in that the person can manipulate, move, and operate the machine alone. He/she is no longer required to schedule treatment with a trained individual. This results in increased psychological and physical freedom and self esteem. The person becomes flexible in his/her treatment and can add extra treatments, if desired, for instance in order to fight a common cold. An additional benefit is the corresponding decrease in cost of treatment, as well as a significant lessening of the weight (and in turn, increased portability) of the device itself. 
         [0005]    An improved vest in accordance with the present invention includes an extension portion defined along a lower portion of the vest, wherein in at least one embodiment the extension portion is generally uninflated during a treatment program. By remaining uninflated, the extension portion tends to retain the vest in a desired orientation, as compared to prior art vests having fully inflated lower portions which tend to “roll” or “curl over” causing the vest to move away from a desired position and/or resulting in a decreased efficiency of the apparatus. The extension portion may be defined by a linear sewing of the upper and lower panels of the vest. The sew line effectively prevents the extension portion from inflating under pressure from the air source during a treatment program. The extension portion may be integrated into the upper and lower vest panels or may be a separate component secured to a lower vest edge during vest manufacture. 
         [0006]    Another improved vest in accordance with the present invention includes an alternative securement approach for securing the vest to the patient. In one embodiment, securement and fitting of the vest to the patient is achieved with a plurality of releasable straps. Hook-and-loop fasteners (e.g., VELCRO brand fasteners) can be used to releasably secure ends of the straps to the vest. Releasable clasps and a fitting structure can also be included to allow the vest to be property fitted to the patient and quickly removed without releasing the hook and loop fasteners. 
         [0007]    The present invention is also directed to a method of applying pressure pulses to the thoracic region of a patient, including positioning a vest having an air bladder and an extension portion at the thoracic region of the patient, with the extension portion controlling movement of a lower portion of the vest so as to minimize curl or roll of the vest during a treatment program. The method may also include coupling the air bladder to a pressurized air line via a multi-port air chamber, and coupling the air bladder to a vent line via the multi-port air chamber. 
         [0008]    The foregoing has outlined rather broadly the features and technical advantages of the present invention in order that the detailed description of the invention that follows may be better understood. Additional features and advantages of the invention will be described hereinafter which form the subject of the claims of the invention. It should be appreciated by those skilled in the art that the conception and specific embodiment disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of the present invention. It should also be realized by those skilled in the art that such equivalent constructions do not depart from the spirit and scope of the invention as set forth in the appended claims. The novel features which are believed to be characteristic of the invention, both as to its organization and method of operation, together with further objects and advantages will be better understood from the following description when considered in connection with the accompanying figures. It is to be expressly understood, however, that each of the figures is provided for the purpose of illustration and description only and is not intended as a definition of the limits of the present invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         [0009]    For a more complete understanding of the present invention, reference is now made to the following descriptions taken in conjunction with the accompanying drawing, in which: 
           [0010]      FIG. 1  is a depiction of functional aspects of an air system of the prior art, which may be used in conjunction with a vest of the present invention. 
           [0011]      FIG. 2  is a top view of a patient vest of the prior art. 
           [0012]      FIG. 3  is a top view of another embodiment of a patient vest of the prior art. 
           [0013]      FIGS. 4-7  illustrate functional aspects of a strap sizing feature of the prior art, which facilitates the proper fitting of patient vests. 
           [0014]      FIG. 8  is a top view of an inner panel portion of a vest according to one embodiment of the present invention. 
           [0015]      FIG. 9  is a top view of an outer panel portion of the vest of  FIG. 8 . 
           [0016]      FIG. 10  is a front and back view of a second vest embodiment of the present invention. 
           [0017]      FIG. 11  is a back view of the vest of  FIG. 10 . 
           [0018]      FIG. 12  is a front and back view of a third vest embodiment of the present invention. 
           [0019]      FIG. 13  is a back view of the vest of  FIG. 12 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0020]    The present invention is directed to an air vest to be used as part of a chest compression system. An example of a suitable chest compression system is described in U.S. Pat. No. 8,192,381, issued to Nozzarella and entitled “Air Vest for Chest Compression Apparatus,” the contents of which are hereby incorporated by reference in their entirety. An embodiment of the chest compression system described in U.S. Pat. No. 8,192,381 is referenced herein by the numeral  10 .  FIG. 1  shows an air flow diagram associated with system  10 . System  10  includes an air flow generator component  12 , flowably connected to a pulse frequency control module  14 , which in turn is flowably connected to a pressure control device  16 , and finally to a vest  18  worn by the patient. The patient may be a human or other animal. For example, both human and equine applications may be practicable, with differently sized vests  18  being defined by the particular applications. In use, the air flow generator (e.g., motor driven blower) delivers pressurized air to vest  18 . The pressurized air is delivered via pulse frequency control unit  14  that preferably includes one or more rotating (e.g., fan-like) blades, such as circular valve blade  20 , which is rotatable upon a central axis of motor  21 . Air flow generator  12  includes an electric blower, the speed of which may be fixed or variable depending on an application. 
         [0021]    Pressure control unit  16  defines a balancing chamber  22  in air communication with ports of module  14 . Chamber  22  is adapted to receive or pass air through the ports of pulse frequency control module  14 , and effectively provides a manifold or air chamber to deliver air to vest  18  or atmosphere by means of vest exit ports  23 ,  24  and atmosphere exit port  25 . Air chamber  22  of pressure control unit  16  provides fluid communication between ports  23 ,  24  and  25 , and hence fluid communication between the ports of pulse frequency control module  14  and air lines  26  to patient vest  18 . 
         [0022]    Pulse pressure control  16  is located between frequency control module  14  and vest  18  worn by the patient. In the illustrated embodiment, air chamber  22  is immediately adjacent pulse frequency control module  14 . In one preferred embodiment, a structure defining the air chamber is directly connected to the outlet ports of the pulse frequency control module  14 . The manifold or air chamber  22  provides fluid communication between air lines  26  extending to vest  18  and the bladder-side ports of the pulse frequency control module  14 . Pressure control unit  16  may be active or passive. For example, an active pressure control unit may include, for example, valves and electric solenoids in communication with an electronic controller, microprocessor, etc. A passive pressure control unit  16  may include a manual pressure relief or, in a simple embodiment, pressure control unit  16  may include only the air chamber providing air communication between the air lines extending to the vest  18  and not otherwise including a pressure relief or variable pressure control. 
         [0023]    System  10  further includes a plurality of quick connect air couplings  28 ,  30  which couple vest  18  with system  10  components within a housing via air hoses  26 . Each quick connect air coupling  28 ,  30  includes male and female portions and a latch or other release for quickly disconnecting the portions. The benefits of the quick connect air couplings include minimization of inadvertent air hose disconnects and improved freedom of movement as the locking air coupling permit rotation between the air hose and the vest or air generator. 
         [0024]    Vest  18  is utilized to provide high frequency chest wall oscillations or pulses to enhance mucus clearance in a patient with reduced mucociliary transport. Vest  18  is adapted to be located around the patient&#39;s upper body or thorax and supported at least partially on the patient&#39;s shoulders. Vest  18  is expanded into substantial surface contact with the exterior of the patient&#39;s upper body to apply repeated pressure pulses to the patient.  FIG. 2  shows an embodiment of vest  18  depicted in U.S. Pat. No. 8,192,381. In this embodiment, vest  18  has an outside cover  32  comprising a non-elastic material, such as nylon fabric. Other types of materials can be used for cover  32 . Cover  32  is secured to a flexible inside liner  34  located adjacent and around patient&#39;s body. An air core or bladder having an internal air chamber and a pair of air receiving ports  36 ,  38  is defined between cover  32  and liner  34 . 
         [0025]    Vest  18  has a pair of upright shoulder straps  40  and  42  laterally separated with a concave upper back edge. Upright front chest portions  44  and  46  are separated from straps  40  and  42  with concave curved upper edges which allow vest  18  to fit under the patient&#39;s arms. Releasable fasteners, such as loop pads  48  cooperated with hook pads  50  secured to the insides of shoulders straps  40  and  42  to releasably secure shoulder straps  40  and  42  to chest portions  44  and  46 . Vest  18  has a first lateral end flap  52  extending outwardly at the one side of the vest. A second lateral end flap  54  extends outwardly from the other side of the vest  18 . 
         [0026]    A plurality of elongated straps  56  are utilized to secure the vest  18  to the patient. Straps  56  each include a releasable connector, such as male and female release buckles  58 ,  60 . Female buckle  60  may be a side contoured buckle. The strap end may pass through the male release buckle  58  and may include a web stop formed by folding the strap end over. Adjustments of strap length may be made by pulling or releasing a strap portion through male release buckle  58 . In the embodiment of  FIG. 2 , straps  56  generally encircle the patient. 
         [0027]    Another embodiment of vest  18  disclosed in U.S. Pat. No. 8,192,381 is depicted in  FIG. 3 . In the embodiment of  FIG. 3 , straps  56  are secured proximate to the vest  18  front and do not otherwise encircle the patient. Instead forces to secure the vest to the patient are transferred directly to the vest  18  rather than indirectly via compression of the jacket by tightened straps  56  as in  FIG. 2 . 
         [0028]    Each strap  56  includes a fitting device which assists in proper fitting of vest  18  to a particular patient. Referring to  FIGS. 4-7 , as disclosed in U.S. Pat. No. 8,192,381, free tab ends  62  are initially positioned directly above marker  64  so that an underlying loop material can engage a corresponding hook structure. Each of the straps  56  are initially provided in this so called “Closed Position” or pre-therapy position as shown in  FIG. 7 . The user then dons the vest  18  and the straps  56  are secured via couplings  58 ,  60  so as to be lightly snug against the patient&#39;s chest. Tabs  62  are then released and resecured into a therapy position as indicated in  FIG. 6 . As a result of the release, an additional length of strap  56  material (length of loop  66 ) is provided to the user permitting slight release of the vest from the patient and otherwise providing a desired level of snugness to the vest against the user&#39;s chest. This fitting device thus permits a quick approach to an optimum sizing of the vest. In the absence of such a device, either the vest is often too snug against the chest or too loose. In either case, device performance is compromised. 
         [0029]    HFCC therapy is prescribed as either an adjunct or outright replacement for manual chest physiotherapy. Total therapy time per day varies between about 30 minutes and about 240 minutes spread over one to four treatments per day. Patients can be instructed in either the continuous intermittent mode of HFCC therapy, which may include continuous use of aerosol. 
         [0030]    During HFCC therapy the patient sits erect, although leaning against a chair back is acceptable as long as air flow in the vest is not restricted. In the continuous mode, the patient operates the vest for 5 minutes at each of six prescribed frequencies (determined by “tuning” performed during a clinic visit). The patient uses the hand control to stop pulsing as frequently as necessary to cough, usually every several minutes. 
         [0031]    In the intermittent mode, the patient uses the hand control to stop pulsing during inspiration to make it easier to inhale maximally. The pulsing is activated again during each expiration. Longer pauses for coughing are taken as needed. The patient goes through the cycle of prescribed frequencies determined by tuning during a clinic visit. 
         [0032]    The vest may be “tuned” for each individual to determine the volume of air expressed from the lung and the rate of flow of this air for each chest compression frequency (e.g., from about 5 Hz to about 22 Hz). The flow rates and volume are calculated with a computer program from flow data obtained during tidal breathing through a Hans Rudolph pulmonary pneumotachometer with pinched nose. The frequencies associated with the highest flow rates are usually greater than 13 Hz, while those associated with largest volume are usually less than about 10 Hz. These best frequencies vary from patient to patient. Since the highest induced flow rates usually do not correspond with largest induced volumes, and since 2 to 3 were commonly very close in value, the three highest flow rates and the three largest volumes are selected for each patient&#39;s therapy. Occasionally one frequency is selected twice because it produces one of the three highest flow rates and one of the three largest volumes. Each of these six frequencies may be prescribed for five minutes for a total of 30 minutes each therapy session. Since the best frequencies change over time with the use of the vest, re-tuning should be performed every 3 to 6 months. 
         [0033]    One explanation of the way in which HFCC moves mucus is derived from observations of the perturbations of air flow during tidal breathing and during maximum inspiration and exhalation to residual volume. Each chest compression produces a transient flow pulse very similar to the flow observed with spontaneous coughing. Tuning identifies those transient flows with the greatest flows and volumes, in effect the strongest coughs, and analogously with the greatest power to move mucus in the airways. 
         [0034]    Referring now to  FIGS. 8-9 , an improved vest  100  of the present invention includes an extension portion  102  defined along a lower portion of the vest. An air core or bladder having an internal air chamber and a pair of air receiving ports  36 ,  38  is defined between cover  32  on the outside of the vest  100  and liner  34  on the inside of the vest. Extension portion  102  is generally uninflated during a treatment program. By remaining uninflated, the extension portion  102  tends to retain the vest  100  in a desired orientation, as compared to prior art vests having fully inflated lower portions which tend to “roll” or “curl over” causing the vest to move away from a desired position and/or resulting in a decreased efficiency of the apparatus. The extension portion  102  may be defined by a linear sewing of the cover  32  and liner  34  of the vest. A sew line  104  effectively prevents the extension portion  102  from inflating under pressure from the air source during a treatment program. 
         [0035]    The sew line  104 , while shown as being linear in form, may be curved or otherwise shaped in alternative embodiments. Also, the sew line  104 , while shown as being generally parallel to the lower edge of the vest  100 , may be oriented in a manner such that it is not parallel to the lower edge of the vest in alternative embodiments. 
         [0036]    In one embodiment, the sew line  104  may be located approximately two (2) inches from the lower edge of the vest  100 . However, in alternative embodiments, the sew line may be located a variety of distances from the lower edge of the vest. 
         [0037]    Further areas of vest  100 , besides extension portion  102 , may be defined by sewing the cover  32  to the liner  34  of the vest. As shown in  FIGS. 8-9 , these areas may include, for example, a side portion  106 , shoulder straps  40  and  42 , and front chest portions  44  and  46 . 
         [0038]    Vest  100  includes shoulder straps  40  and  42  and releasable fasteners, such as loop pads  48  cooperating with hook pads  50  secured to the inside of shoulder straps  40  and  42 . In alternative embodiments of the present invention, the vest may not include shoulder straps  40  and  42 , and may therefore be shoulder-less. 
         [0039]    In the vest  100 , rear strap portions  56  are removed (as compared with the prior art vest of  FIG. 2 ) and replaced with relatively short straps  108 . A plurality of straps  108  are utilized to secured the vest  100  to the patient. Straps  108  each include a releasable connector, such as male and female release buckles  58 ,  60 . Female buckle  60  may be a side contoured buckle. 
         [0040]    VELCRO brand hook-and-loop fasteners may be used to releasably secure sides of the vest  100  together at the lower edge of the vest. As shown in  FIG. 8 , a hook portion  110  of the hook and loop fastener system may be provided at a side of the lower edge of the vest  100 . As shown in  FIG. 9 , the loop portion  112  of the hook and loop fastener system is then provided on the other half of vest  100 . 
         [0041]    In the vest  100 , the extension portion  102  is designed to remain uninflated during application of pressurized air into the vest  100 . Vest  100  has improved patient performance as compared to prior vest versions as the tendency of the lower portion of vest  100  to roll or curl over is greatly reduced. The extension portion  102  may be defined by sewing the cover  32  and liner  34  (i.e. the upper and lower fabric panels of the vest  100 ) together. Alternatively, a separate extension portion  102  could be sewn or otherwise secured to the lower portion of the vest  100 . The separate extension portion  102  (not shown) could be made of different materials as compared to the panels of the vest  18 . The extension portion  102  need not comprise a cover  32  and liner  34  (i.e. upper and lower panel segments). In an alternative design, extension portion  102  could be a single ply material which is sewn or otherwise connected to the lower portion of vest  100 . The single ply material may be substantially more rigid than the upper ply forming the cover  32  and lower ply forming the liner  34  of the vest. In yet another design, the extension portion  102  could be defined by relatively stiff material that could be inflated during a treatment program. For example, a relatively stiff insert could be secured to the upper or lower panel of vest  100 , with the insert tending to resist roll-up or curl-over of the lower edge of the vest  100  during a treatment program. It is envisioned that alternative structures, either incorporated into the vest panels or otherwise secured to the vest, could be used to eliminate or minimize the tendency of a vest to curl or roll upon application of repeated air pulses. 
         [0042]    Referring now to  FIGS. 10-11 , another improved vest  200  in accordance with the present invention includes an alternative securement approach for securing the vest  200  to the patient. In one embodiment, securement and fitting of the vest to the patient is achieved with a plurality of releasable straps  202 . VELCRO brand hook-and-loop fasteners can be used to releasably secure ends of the straps  202  to the vest  200 . Releasable clasps  204  and a fitting structure  210  (such as the fitting structure described above in connection with  FIGS. 4-7 ) can also be included to allow the vest  200  to be property fitted and quickly removed. Hook portions  212  of the hook and loop fastener system may be provided at ends of the straps  202 , with the other end being secured to the vest  200 . The loop portions  214  of the hook and loop fastener system are provided on the other half of vest  200 . Vest  200  can be removed by releasing the clasps  204  or by disengaging the hook and loop fasteners, such as by pulling on loops  216  proximate to the hook portions  212 . 
         [0043]      FIGS. 12-13  show another embodiment of the present invention, depicted as vest  300 . Vest  300  includes the features of both vest  100  and vest  200 . By having both the extension portion  102  and the releasable clasps  204 , fitting structure  210 , and releasable straps  202 , patient fitting and compliance may be improved. The vest  300  can be removed either by releasing the mechanical clasps  204  or releasing the hook and loop fasteners securing one end of the straps  202  to the vest  300 . 
         [0044]    The vest of the present invention may be used with air pulse generating devices such as, but not limited to, the air pulse generating device disclosed in U.S. Pat. No. 8,182,381. It is envisioned that the improved vest of the present invention could be used with a variety of commercially available air pulse generators. 
         [0045]    Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure of the present invention, processes, machines, manufacture, compositions of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present invention. Accordingly, the appended claims are intended to include within their scope such processes, machines, manufacture, compositions of matter, means, methods, or steps.