Abstract:
A universal respiratory adaptor for connecting medical equipment to a patient respiratory device comprises: 
     i) a machine end comprises at least two male tapers of different diameters; 
     ii) a patient end comprises a first female port concentric within a second female port, wherein the second female port has an outer wall which defines a male fitting, and 
     iii) a tubular body portion interconnecting the machine end and the patient end; 
     wherein the machine end and the body portion comprise a continuous lumen in fluid communication with the first female port.

Description:
FIELD OF THE INVENTION 
     The present invention relates to the field of couplers or adaptors for connecting anaesthesia, ventilator, breathing circuits, resuscitator, medication, or medical treatment devices to other respiratory components including face masks, endotracheal tubes, tracheotomy tubes or their connectors. 
     BACKGROUND OF THE INVENTION 
     Breathing devices of various type are routinely used to connect a patient to a respirator or anesthetic delivery machine. The device to be used depends on the mode of communication with the patient&#39;s lungs that is desired. For example, this communication may be achieved through the use of a facemask through which the patient breathes or through the use of a tube which is inserted into the trachea. As well as variation in the breathing devices used, there is variation in the anesthesia or respiratory systems used. For example, it is preferable to use smaller diameter tracheal tubes and breathing systems for children. Thus, there is a wide variety in terms of the sizes of the connectors of the various breathing devices and in terms of sizes of the connectors of the various anesthesia and respiratory systems. A real problem is encountered when the connector of a breathing device such as a tracheal tube or face mask is not compatible with the connector of the anesthesia or respiratory system and precious time may be lost trying to find and assemble intermediary connectors. 
     Various types of adaptors or connectors have been developed to connect a breathing device to a respiratory system. Typically a respirator or anesthesia machine is attached to a Y-piece via inhalation and exhalation tubings. The stem of the Y-piece typically comprises a port to which a tracheal tube connector or facemask can be attached. Various improvements on the basic concept have been attempted. For example, U.S. Pat. No. 4,557,261 describes a connection system for respirator or anesthesia units in which the plug connection is replaced by a system in which disconnection can be effected quickly and easily by actuation of a lever arm on a fastening device. 
     U.S. Pat. No. 5,735,271 discloses multiple access adaptors for monitoring, sampling, medicating, aspirating and ventilating the respiratory tract of a patient. While a multiplicity of access ports has some advantages, this device does not address the problem of incompatibility between various components of a breathing system. 
     The optimal respiratory system for an adult might not be optimal for a child or infant. U.S. Pat. No. 4,838,255 discloses a system in which secretions which accumulate in the lungs of an infant or small child can be removed without interrupting the ventilation of the lungs. However, this device does not address the problem of incompatibility between child-oriented and adult-oriented connectors and equipment. 
     Another type of connector is described in U.S. Pat. No. 5,309,906 which discloses an intubating device or tracheal tubular member for carrying a gas to or from the lungs of the patient which includes an adaptor for interconnecting the tubular member with a source of gas. A compact assembly is provided at the junction of the suction and ventilating hoses so that they are directed to pass over the patient&#39;s head, thus removing them from surgical areas that involve the lungs or trachea. 
     In addition to those described above, many other types of anesthesia and/or respiratory connectors have been designed. However, in spite of the numerous types of adaptors that have been developed, there remains a real and unmet need for a universal connector that facilitates adaption between the exposed fitting of various sized endotracheal tubes and various types of aspirating, respiratory, or anesthesia machines. 
     SUMMARY OF THE INVENTION 
     It is an object of an aspect of the present invention to provide a universal adaptor that can facilitate the quick and reliable connection and disconnection of different types of breathing devices to various sizes of respiratory equipment without the need to maintain a large inventory of incompatible parts. 
     According to one aspect of the invention, there is provided a universal respiratory adaptor comprising: 
     i) a machine end comprising at least two male tapers of different diameters; 
     ii) a patient end comprising a first female port concentric within a second female port, wherein said second female port has an outer wall which defines a male fitting; and 
     iii) a tubular body portion interconnecting said machine end and said patient end; 
     wherein said machine end and said body portion comprise a continuous lumen in fluid communication with said first female port. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     Preferred embodiments of the invention are described with respect to the drawings wherein: 
     FIG. 1 is a perspective view illustrating various components that may be connected to the patient end of the adaptor of the present invention; 
     FIG. 2 is a side, partly sectioned, view of the adaptor connected to a child-sized tracheal tube; 
     FIG. 3 is a side, partly sectioned, view of the adaptor connected to an adult size tracheal tube; 
     FIG. 4 is a side, partly sectioned view, of the adaptor connected to a facemask; 
     FIG. 5A is a perspective view of an embodiment of the adaptor which is straight; and 
     FIG. 5B is a perspective view of an embodiment in which the adaptor is an Ayre&#39;s T-piece. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     In many situations, it may be necessary to quickly change the apparatus to which a patient&#39;s breathing device is connected. For example, it may be desirable to quickly switch from giving a patient oxygen by facemask to giving them anesthetic by tracheal tube. In other cases, it may be desirable to rapidly switch from ventilating the lungs with gases to aspirate secretions or to oxygenate the lungs. These changes must be done reliably and quickly without compromising the safety of the patient. 
     Further problems may arise when respiratory distress occurs in infants and small children having respiratory problems. This is particularly common in premature infants and newborns. Pediatric and neonatal ventilation has special requirements regarding the size of the tubing to be used (i.e. it should be small and have a low volume). The preferred systems for use in children and in adults typically do not have the same size connectors and thus in an emergency situation, valuable time may be lost trying to connect incompatible systems. For example, when an infant or child is brought to an emergency room in an ambulance, the paramedics may have already inserted an endotracheal tube. If an infant sized endotracheal tube with its associated connector has been inserted and the emergency room only has equipment adapted for connection to an adult sized tracheal tube, intermediary connectors have to be found and quickly attached or else the tracheal tube may have to be replaced. Either way critical time is wasted. On the other hand, if a tracheal tube with an adult sized connector is inserted, this may cause problems if it is determined that the child would be best treated in the neonatal intensive care unit where the respirators and other types of equipment are child-oriented and thus have connections which are incompatible with the adult sized tracheal tube connector. 
     The present invention addresses these problems by providing a universal respiratory adaptor that can be used to rapidly connect and disconnect incompatible pieces of equipment. 
     The adaptor  10  has a patient end  12 , for connection to a patient device, and a machine end  14  for connection to the tubing of a respirator, anesthetic machine, aspirator or any other medical apparatus that one wants to communicate with the patient device. The patient end  12  is a three-step connector and thus can be connected to at least three different sized breathing devices. The machine end  14  can be connected to at least two different sized ports. 
     Referring now to FIG. 1, the potential connection of a variety of patient devices to the adaptor is illustrated. The adaptor  10  comprises a patient end  12  and a machine end  14  for connection to other equipment. A tubular body portion  16  is interposed between the patient end  12  and the machine end  14 . The adaptor  10  comprises, at the machine end  14 , at least two male tapers. A first male taper  18  is smaller in diameter than a second male taper  20 . The patient end  12  has concentric female ports  22 ,  24 . Each of the female ports comprise a circular wall  26 ,  28 , respectively, of uniform thickness which terminates in a blunt leading edge  30 ,  32 , respectively. The circular walls of the female ports  22 ,  24  have inner wall surfaces  34 ,  36 , respectively and outer wall surfaces  38 ,  40  respectively. The outer wall  40  of the larger female port  24  acts as a male fitting  42 . The male fitting  42  is adapted in size to fit into the female port  44  of a facemask  46 . The larger female port  24  is adapted to receive the connector  48  of an adult sized tracheal tube  50  and the smaller female port  22  is adapted to receive the connector  52  of a child sized tracheal tube  53 . The adaptor may optionally include a port  54  which can be used for the measurement of respiratory gases. This port  54  may have an internal diameter suitable to admit a suction catheter. The adaptor  10  may also include a fitting for administration of therapeutic materials, such as humidity, nitric oxide or other medications. As shown in FIGS. 2 to  4 , the machine end  14  and the body  16  together comprise a continuous lumen  56  which communicates with the female port  22 . 
     In a preferred embodiment, the adaptor  10  comprises, at the machine end  14  for connection to other respiratory equipment, an 8.5 mm. male taper  18  with a lumen at least 6 mm. ID, in series with and adjacent to a 15 mm male taper  20  with a lumen at least 6 mm. ID. The body  16  has a lumen at least 8 mm. ID and may include a gas sample port. This port may admit a 3.3 mm. (10 Fr gauge) [OD 3.3+1−0.15 mm] suction catheter. The body may also carry a conventional 6 to 10 mm. cone connector for supply of gas or vapours, or another connection for supply of medication. Using minimal dead-space, the body  16  connects, at the patient end  12  to a concentric 8.5 mm taper female port  22  within a 15 mm. taper female port  24 , where the outer wall  40  of the female port  24  defines a 22 mm. taper male fitting  42 . The space between the concentric 22 mm. male and 15 mm. female parts may be solid, or hollow, or supported by several radial fins. 
     The connection of the small size tracheal tube connector  52  can be seen in FIG.  1  and in more detail in FIG.  2 . The connector  52  comprises a circular wall  58  which defines a lumen  60 . The circular wall  58  comprises an inner wall surface  62  and an outer wall surface  64  which terminate in a blunt edge  66 . The outer wall  64  of connector  52  fits into the female port  22  and  10  engages the inner wall  34  of the port  22  for a press fit connection that is virtually airtight so as not to affect the flow of gases from the port  22  through the lumen  60 . In a preferred embodiment the  22 ,  15  and 8.5 mm dimensions meet the requirements of EN1281. 
     At the machine end  14 , the male taper  20  may be connected, for example, to the connector tubing of a child-adapted respiratory apparatus. Alternatively, it is clearly apparent that the larger male taper  20  could be connected to the larger size connector of an adult respirator thus providing a step up from a small size to a larger size as shown in FIG. 3 (not shown in FIG.  2 ). 
     FIGS. 1 and 3 illustrates an adult size tracheal tube connector  48  attached to the adaptor  10 . The tracheal connector  48  comprises a circular wall  80  which defines a lumen  82 . The circular wall  80  has an inner surface  84  and an outer surface  86  which terminate in a blunt edge  88 . The outer surface  84  of the adaptor engages the inner wall  36  of the second female port  24  in a press fit. A space  90  remains between the outer wall  38  of the first female port  22  and the inner surface  84  of the tracheal tube connector  48 . In a preferred embodiment, the female port  24  is sized, in accordance with recognized standards to accommodate a 15 mm. male fitting. 
     The larger male taper  20  at the machine end  14  may be attached to the tubing  94  of an adult-oriented respirator, as illustrated in FIG. 3, or the smaller male taper  18  may be attached to the connector of child adapted equipment to provide a step down. In a preferred embodiment the first male taper  18  is an 8.5 mm. taper and the second male taper  20  is a 15 mm. male taper. It is clearly apparent that other two step tapers, such as 11 mm. and 15 mm. tapers, can also be used depending on the prevalence of particular types of apparatus connectors. 
     FIGS. 1 and 4 illustrates how a facemask  46  can be attached to the adaptor  10 . The face mask comprises a circular wall  96  which defines a female port  44 . The circular wall  96  has an inner wall surface  98  and an outer wall surface  100  which terminate in an edge  102 . The inner wall  98  of the female port  44  of the facemask  46  engages the outer wall  40  of the second female port  24  which forms the male fitting  42 . In a preferred embodiment, the male fitting  42  is a 22 mm. male fitting. The circular wall  28  which defines on its inner surface  36  the female port  24  and on its outer surface  40  the male fitting  42  may be solid, hollow or supported by several radial fins. At the machine end  14 , the adaptor  10  can be connected to either child-adapted or adult adapted equipment. 
     While the adaptor  10  has thus far been illustrated as being essentially L-shaped, it is clearly apparent that the adaptor can also be linear, as illustrated in FIG.  5 . The patient end  110  of the adaptor comprises concentric female ports  112 ,  114  and a male fitting  116 . The machine end  118  comprises two male tapers  120 ,  122 . The adaptor may be a straight coupler or it may be a T-connector. When a T-connector is to be used, the machine end  118  including both the small  120  and large male taper  122  should be sufficiently long to engage the connector tubing of the respiratory machine without interference from the T-piece  124 . 
     The adaptor may be manufactured in metal, or plastic material compatible with anaesthetic agents or medications to which it may be exposed and is resistant to deformation, binding or bonding to mating components. 
     This allows safe and quick change of connections between a patient and a breathing circuit when fittings of different EN Standard sizes are used, articularly between standard child fittings and a breathing circuit of a different standard size. The adaptor may be manufactured to also provide compatibility with other non-EN systems, eg 11 mm systems. 
     The adaptor of the present invention provides for an easy, secure connection between 8.5 mm taper respiratory system devices commonly used in small children, infants, neonates and premature babies and 1) devices made with a 15 mm taper according to ISO 5356/EN 1281 which is the standard taper for use in large children and adults, and 2) face masks which usually have a 22 mm female port, but may have a 15 mm. male taper. 
     The rapid connection between components of the ‘8.5 mm.’ and the ‘15/22 mm’ systems is especially important in emergency resuscitation at birth, accidents, cardiac arrest, and in the induction of anaesthesia when it is necessary to rapidly change connections from a face-mask to a tracheal tube connector or tracheostomy tube connector. 
     When the present adaptor is used, it is not necessary for the anaesthetist to prejudge whether anaesthesia will continue using an 8.5 mm. system, or a 15 mm. system, nor is it necessary to provide a series of intermediary connectors to facilitate the various connections which may be required. 
     The present invention facilitates interconnection between different interfaces and provides for harmonization between different types of equipment. The adaptor can be used in a variety of different situations. Potential users include, but are not limited to anaesthetists, neonatologists, obstetricians, paediatricians, intensivists/critical care specialists, otolaryngologists, surgeons, respiratory therapists, paramedics, medevac technicians, nurse practitioners, nurses, and other health care professionals. 
     Although preferred aspects of the invention are described with respect to the drawings, it is understood that variations may be made thereto without departing from the spirit of the invention or the scope of the appended claims.