Abstract:
The present invention relates to a sputum trap for an aspiration and respiratory support system which includes a manifold attachable to a specimen collection vial that is interposed between, and attached to, a suction control device and suction catheter device. The sputum trap allows for the collection of sputum directly from a patient through a suction catheter without causing a loss of Positive End Expiratory Pressure (PEEP) in the respiratory support system. The manifold includes a manifold body that has a first connector and a second connector for attachment to the suction control device and suction catheter, respectively, and an open port for secure attachment to the specimen collection vial. The manifold body further includes tethered first and second caps adapted for sealing the first and second connectors respectively from fluid flow communication once sufficient sputum has been collected in the specimen collection vial. A nest is formed on the top portion of the manifold body for conveniently storing the first and second caps during the collection of sputum without interfering with the operation of device.

Description:
CROSS-RELATED APPLICATIONS 
     This patent application claims priority from United States Provisional Application Serial No. 60/055,702, filed on Aug. 14, 1997, by Babkes et al., the entire contents of which are hereby incorporated herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates generally to an apparatus used in the collection of sputum directly from a patient in a respiratory support system and more particularly to a sputum trap manifold that provides a convenient storage site for storing caps used to seal the connectors of the manifold. More specifically, the present invention relates to a sputum trap manifold that forms a nest adapted to conveniently store the caps prior to detachment of the sputum trap manifold from the respiratory support system. 
     2. Prior Art 
     Respiratory support systems used for the ventilation of critically ill patients are now commonly used in medical facilities. Typically, a prior art respiratory support system includes a tracheal tube positioned either directly, or through the nose or mouth, into the trachea of a patient, a manifold connected to the tracheal tube at one port positioned thereof, and a source of breathable gas connected at a second port thereof. The purpose of the respiratory support system is to assist the patient in maintaining adequate blood oxygenation levels without overtaxing the patients&#39;s heart and lungs. 
     While a patient is attached to the respiratory support system, it is periodically necessary to aspirate fluid from the patient&#39;s trachea or lungs. In the past, in order to accomplish aspiration, it has been necessary to disassemble part of the respiratory support system, either by removing the ventilator manifold therefrom or by opening a port of the manifold and inserting a small diameter suction tube down the tracheal tube and into the patient&#39;s trachea and lungs. However, there has been no solutions to the problem of sputum sample collection during aspiration, which also avoids the problem of respiratory support interruption. 
     U.S. Pat. No. 4,433,195 to Kee is generally exemplary of the prior art sputum sample collection during the aspiration of a patient&#39;s trachea and lungs without loss of respiratory support to the patient. The Kee device relates to an in-line sputum trap for a respiratory support system having a collection vial for receiving and storing a sputum specimen and a manifold that connects the sputum trap in fluid flow communication to a suction catheter used to aspirate a patient&#39;s trachea and lungs and a suction control valve which controls the flow of vacuum to the suction catheter. The sputum trap is designed for quick connect and disconnect with the suction catheter device and the suction control valve after having been used to collect a sputum sample from a patient. After collection of a sputum sample, the sputum trap is disconnected from the respiratory support system and the manifold is detached from the collection vial so that the collection vial can be sealed with a suitable cap for transportation. Unfortunately, a clinician removing the manifold from the collection vial may be inadvertently exposed to contaminates until the collection vial can be safely resealed. 
     U.S. Pat. No. 5,363,860 to Nakao et al. is generally exemplary of a sputum trap device that includes a pair of tethered caps used for sealing the inlet and outlet of the sputum trap&#39;s manifold after disconnection from the respiratory support system, thereby removing the need to detach the manifold from the collection vial. However, the Nakao et al. device suffers from drawbacks. One drawback is that the sputum trap has no convenient storage site to store the tethered caps so that the caps do not interfere with the operation of the suction catheter during aspiration of a patient&#39;s trachea and lungs. Another drawback is that there is no sanitary means provided in the Nakeo et al. device for preventing inadvertent contamination of the tethered caps by a clinician&#39;s hands during the aspiration procedure since the caps are permitted to freely dangle until used to seal the manifold&#39;s connectors. 
     As of yet, nothing in the prior art has addressed the problem of developing a nest or storage site on the body of the sputum trap manifold for conveniently storing in a sanitary environment a pair of tethered caps used to seal the inlet and outlet connectors of the sputum trap manifold. Moreover nothing in the prior art has addressed the need for developing a nest or storage site for nesting a pair of tethered caps so that the tethered caps do not interfere with the collection of a sputum specimen during aspiration of a patient&#39;s trachea and lungs. 
     OBJECTS AND SUMMARY OF THE INVENTION 
     The principle object of the present invention is to provide a sputum trap manifold having a storage site for conveniently nesting end caps that are used to seal the connectors of the manifold after the collection of sputum from the patient. 
     Another object of the present invention is to provide sealing end caps that are specifically adapted for nesting one cap on top of the other in the storage site formed on the sputum trap manifold. 
     A further object of the present invention is to provide end caps that are adapted for nested storage as well as for sealing engagement to the connectors of the sputum trap manifold. 
     A further important object of the present invention is to provide an improved sputum trap manifold with sealing end caps which does not require the removal of the manifold in order to seal off the collection vial after use. 
     Another principle object of the present invention is to provide a safe and sanitary means of sealing off the sputum trap manifold after the collection of sputum from the patient. 
     Another further principle object of the present invention is to provide a method for nesting end caps on the body of the manifold. 
     Another important object of the present invention is to provide a method of capping the manifold connectors which minimizes the opportunity for contamination to the clinician by the manifold&#39;s connectors during the capping procedure. 
     These and other objects of the present invention are realized in the preferred embodiment of the present invention, described by way of example and not by way of limitation. The preferred embodiment provides for a sputum trap manifold having an integral nesting site for storing end caps used to seal the connectors of the manifold after the collection of sputum from the patient. The sputum trap manifold comprises a manifold body having two end connectors adapted for connection to a source of suction and a suction catheter, respectively, as well as an outlet for attachment to a collection vial. The manifold body serves to diverst and trap sputum being suctioned from the lungs of a patient and into the collection vial attached to the manifold. A nest is formed at the top portion of the manifold body for nesting two tethered end caps during sputum collection. Once aspiration of a patient&#39;s lungs is completed, the manifold is detached from the respiratory support system and the end caps are removed from the nest and sealably attached to the manifold&#39;s end connectors, thereby preventing the user from having to remove the manifold in order to reseal the collection vial and lessen exposure to contaminants from the collected sputum. 
     Finally, the present invention further includes a method for storing the end caps in the nest formed on the manifold and sealing the end connectors of a sputum trap manifold with the end caps without having to remove the manifold body from the collection vial. The method of nesting and sealing the end connectors of the sputum trap manifold comprises the steps of nesting one end cap over the other end cap in the nesting site after manufacturing, detaching the manifold&#39;s end connectors from the source of suction and suction catheter after the aspiration procedure has been completed, and removing the end caps from the manifold&#39;s nesting site. Once the end caps are removed, each end cap is sealingly attached to a respective end connector, thereby preventing the exposure of contaminants from collected sputum through the end connectors. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a perspective view of the sputum trap manifold showing the end caps in sealing engagement with the end connectors of the manifold body according to the present invention; 
     FIG. 2 is a perspective view of the tethered end caps according to the present invention; 
     FIG. 3 is a top view of the sputum trap manifold showing the end caps in sealing engagement with the end connectors of the manifold body according to the present invention; 
     FIG. 4 is a side view of the sputum trap manifold showing the end caps nested in the manifold&#39;s nest according to the present invention; 
     FIG. 5 is a cross section view of the manifold body along lines A—A showing the end caps nested in the manifold&#39;s nest according to the present invention; 
     FIG. 6 is a cross-section view of the manifold body along lines B—B showing the end caps nested in the manifold&#39;s nest according to the present invention; and 
     FIG. 7 is an end view of the manifold body according to the present invention. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring to the drawings, the preferred embodiment of the sputum trap with nested end caps of the present invention is illustrated and generally indicated as  10  in FIG.  1 . As shown in FIG. 1, the sputum trap  10  comprises a manifold body  12  that includes a female connector  14  that is opposed by a male connector  16  and an outlet  17  interposed therebetween that is adapted for attachment to a collection vial  11  for the collection of sputum from a patient. The manifold body  12  further includes a nest  18  formed on the top portion of the body  12  for storing a male end cap  22  on top of a female end cap  20  in a nested configuration therein. As illustrated in FIG. 1, the female and male connector end caps  20  and  22  are adapted to seal off female and male connectors  14  and  16 , respectively, as well as to be stored inside the nest  18  prior to sealing off the connectors  14  and  16 . 
     FIG. 2 shows the female and male connector end caps  20  and  22  in greater detail. Both the female connector end cap  20  and the male connector end cap  22  are held together by a tether  24  at an attachment member  26  which is attachable to the manifold body  12  by an L-shaped attachment opening  28  formed through the body of the attachment member  26 . Preferably, the attachment opening  28  is adapted for snap-fit connection to a similarly L-shaped attachment portion  27  formed on the manifold body  12 , although the attachment member  26  may also be integrally formed with the manifold body  12 . 
     Male connector end cap  22  comprises a cap body that forms a bottom portion  42 , a mid portion  44  and a top portion  46  which are all in co-axial alignment with one another. Opposed L-shaped first bayonet slots  50  are formed on the bottom portion  42  of male connector end cap  22  and serve to securely engage the male connector end cap  22  to either the female connector end cap  20  during nesting or the male connector  16  when sealing the manifold body from fluid flow communication. Formed on the outside surface of the mid and top portions  44  and  46  of male connector end cap  22  are opposing grips  48  adapted for gripping between a user&#39;s thumb and forefinger when the user is either engaging the male connector end cap  22  to the female connector end cap  20  when nesting the two end caps  20  and  22  together or when sealing off the male connector  16  after the collection of sputum. 
     Female connector end cap  22  comprises a lower portion  36  and an upper portion  34 . Upper portion  34  is a frustoconical shaped body having a head section  38  and a conical section  40  that are adapted for engagement to either the nest  18  when nesting the two end caps  20  and  22  together or when sealing off the female connector  14  after the manifold body  12  is detached from the suction catheter and suction control valve (not shown). The lower portion  36  has an open interior cavity  31  having a tubular cross-section with opposed handles  32  formed on the surface thereof. Preferably, opposing handles  32  are bar-shaped and provide a convenient gripping surface for handling the female connector end cap  22  between the user&#39;s thumb and forefinger and, as shall be discussed in greater detail below, an integral component for nesting the female connector end cap  20  to the male connector end cap  22  in the nest  18  without contaminating the interior portion of either end cap  20  or  22  with the clinician&#39;s hands. Interposed between the upper portion  34  and the lower portion  36  are opposed securing members  30  which form radially extending protrusions adapted for securing the female connector end cap  20  to the nest  18  as well as assist in engaging and sealing off the female connector  14  of the manifold body  12 . In securing the female connector end cap  20  to the female connector  14 , the opposed securing members  30  engage opposed L-shaped second bayonet slots  52  by aligning and inserting each of the securing members  30  with a respective slot  52  until securely engaged thereto. 
     Referring to FIG. 3, a top view of nest  18  is illustrated. Nest  18  comprises a nest cavity  56  that forms a nest opening  57  at the top portion of cavity  56  and a plurality of opposed guide members  54  integrally formed along the interior wall at the bottom portion thereof. The bottom portion of nest cavity  56  also includes a bowl-shaped depression  25  that is adapted to receive the head section  38  of the female connector end cap  20  once the end cap  20  has been inserted and guided into position inside the nest  18 . Preferably, the guide members  54  form equally spaced posts around the periphery of the nest cavity&#39;s  56  bottom portion in order to guide the upper portion  34  of the female connector end cap  20  into the nest cavity  56  as the end cap  22  is inserted into the nest  18 . However, any number of guide members  56  positioned along the periphery of the nest cavity&#39;s  56  bottom portion in a manner suitable for guiding and receiving the female connector end cap&#39;s  20  upper portion  34  is felt to fall with the scope of the present invention. The nest opening  57  also includes opposed slots  58  formed on the lip thereto that are adapted to receive respective securing members  30  when inserting the female connector end cap  22  into the nest  18 . 
     Referring to FIG. 4, a more detailed description of the female and male connectors  14  and  16  will be discussed. Male connector  16  has a generally conical shape comprising a top section  60 , a mid section  62  and a bottom section  64  with a first opening  19  that is in fluid flow communication with a manifold chamber  74  (see FIG. 5) of manifold body  12  and forms the free end of connector  16 . In order to engage the first bayonet slots  50  of the male connector end cap  22  and seal the male connector  16  from fluid flow therethrough, opposed connecting members  51  that form protruding arms are provided on connector  16 . These protruding arms of the connecting members  51  are adapted for insertion into the L-shaped slots  50  and rotated therein so as to establish a firm connection between the male connector  16  and the male connector end cap  22 . 
     Female connector  14  has a frustoconical shape with a second opening  21  formed along the edge of connector  14  that is in fluid flow communication with the manifold chamber  74  and a neck  23  that is integrally formed to the manifold body  12 . An opposed L-shaped second bayonet slots  52  are formed on the body of female connector  14  that extends from the connector&#39;s  14  free end. In order to engage the second bayonet slots  52  of female connector  14 , the securing members  30  of the female connector end cap  20  are inserted into the L-shaped slots  52  and rotated therein so as to establish a firm connection between the connector  14  and the end cap  20 . 
     Referring to FIG. 5, the interior of the manifold body  12  will be discussed in greater detail. As noted above, the manifold body  12  comprises an manifold cavity  74  that is in fluid flow communication with the male connector&#39;s  16  first opening  19  and the manifold cavity  74  through a first channel  70  interposed therebetween. Fluid flow communication is also established between a second opening  21  of female connector  14  and the manifold cavity  74  through a second channel  72  interposed therebetween. A splash guard  68  is provided at one end of the manifold cavity  74  facing the entrance to the first channel  70  for diverting aspirated sputum from the patient downward through the outlet  17  and into the collection vial  11  attached thereto. Thus, a first fluid pathway is established through the first channel  70 , a second fluid pathway is established through the second channel  72 , and a third fluid pathway is established between the first and second channels  70  and  72  through the collection vial. A seal  80  may also be provided along a portion of the interior surface of the female connector  14  for establishing and maintaining a secure hermetic seal around the female connector end cap  20  when the end cap  20  is engaged thereto. Preferably, the seal  80  is made from a flexible plastic or rubber material, for example polyurethane, that is suitable for creating a hermetic seal. Finally, a plurality of strengthening members  66  are provided around the lower periphery of the manifold cavity  74  for reinforcing and strengthening the manifold body  12 . 
     Referring back to FIGS. 3 and 4, the method for nesting the female and male connector end caps  20  and  22  in the nest  18  will now be discussed in greater detail. After manufacturing and prior to engaging the sputum trap  10  to the suction catheter and suction control valve the female and male connector end caps  20  and  22  are stored in the nest  18  so that neither end caps  20  and  22  nor the tether  24  interfere with the operation of the closed system suction catheter. To nest female and male connector end caps  20  and  22 , the head section  38  of female connector end cap  22  is first inserted into the nest  18  so that the opposed securing members  30  engage respective opposed slots  58 . When the head section  38  enters the nest  18  it is guided by the guiding members  54  so that the section  38  comes in contact with the bowl-shaped depression  25  located at the bottom portion of nest  18 . Once the female connector end cap  20  is fully inserted into the nest  18 , the user grips the outer surface of the male connector end cap  22  and orients the cavity  25  of end cap  22  over the open bottom portion of the female connector end cap  20  already seated in the nest  18  as illustrated in FIG.  6 . When placing the male connector end cap  22  over the female connector end cap  20  the user orients the first bayonet slots  50  of the male connector end cap  22  over the handles  32  of the female connector end cap  20  in such a manner that minimal rotation of the end cap  20  around the other end cap  22  is possible as shown in FIG.  7 . 
     Once the patient has been sufficiently aspirated and sputum collected in the collection vial  11 , the female and male connectors  14  and  16  of sputum trap  10  are disengaged from the suction catheter and suction control valve, respectively. After the sputum trap  10  is disengaged, the male connector end cap  22  is removed from its nested position on the female connector end cap  20  and attached in sealing engagement to the male connector  16  by aligning and engaging the first slots  50  of the end cap  22  with the connecting members  51  of the connector  16 . Similarly, once the male connector end cap  22  is nested, the female connector end cap  20  is removed from the nest  18  and the upper portion  34  thereof inserted in sealing engagement with the female connector  14  in such a manner that the securing members  30  of the end cap  20  fully engage the L-shaped second bayonet slots  52  of female connector  14 . In this sealed state the collection vial  11  and its attached sealed manifold can be safely stored and transported without fear of exposing a user to contaminants. 
     It should be understood from the foregoing that, while particular embodiments of the invention have been illustrated and described, various modifications can be made thereto without departing from the spirit and scope of the invention. Therefore, it is not intended that the invention be limited by the specification; instead, the scope of the present invention is intended to be limited only by the appended claims.