Patent Publication Number: US-2019167936-A1

Title: Nasal Cannula Clamping and Patient Monitoring System

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is a Continuation In Part of U.S. Patent Application Ser. No. 15/830,515 filed Dec. 4, 2017, which application is incorporated in its entirety herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates to a nasal cannula and in particular to a parabolic clamping grooves system and monitor for use with the nasal cannula. 
     Nasal cannulas are connected to a patient to provide a flow of gases into the patient&#39;s nose. The source of the treatment and/or medication to the patient through the nasal cannula are prescribed along with the flow rate of gas such as oxygen, room air, and any gas mixture, etc. in Liters Per Minute (LPM) by an attending physician and connected to the nasal cannula input line to the patient and attended to by a physician, nursing staff (if hospitalized), patient/family (if at home), etc. 
     Known cannula clamps grasp round tubes between circular halves. Because the tubes and the clams both have round cross-sections, the clamps must have a smaller inside diameter than the tubing outside diameter to grasping the tubing. As a result, the clamps must at least partially collapse the tubing to prevent the tubing from slipping inside the clamp, and thereby restrict the flow of gases to the patient. 
     BRIEF SUMMARY OF THE INVENTION 
     The present invention addresses the above and other needs by providing a nasal cannula clamping system which holds a nasal cannula in position on a patient. The nasal cannula clamping system includes a nasal cannula clamp assembly having a clamp body and a clamp block grasping nasal cannula tubes in two non-round parallel passages/grooves which securely clamps the two tubes under the chin while not compromising the distribution of medication prescribed by the attending physician. The nasal cannula tubes are sandwiched between the clamp body and clamp block which also contains the non-round parallel passages/grooves. 
     In accordance with one aspect of the invention, there is provided a nasal cannula clamping system providing enhanced flow to a patient. In many cases, a nasal cannula is worn while sleeping. If the nasal cannula moves sufficiently during sleep, the patient is awakened, losing important sleep time, and if the flow is interrupted, the patient may experience health risks. Also, the patient can be monitored in regard to certain vital health aspects without disturbing or wakening said patient via Wi-Fi wireless connection. The nasal cannula clamping system is also completely self contained without the need for peripheral equipment either attached to the individual or stand alone such as bench top analytical equipment for analyzing breathing habits, O2 to blood ratio, heart rate to name a few and is all handled by the self contained unit via Wi-Fi. 
     In accordance with still another aspect of the invention, there is provided a nasal cannula clamping system including a lock screw tightening a clamp block against a clamp body to hold nasal cannula tubes in place under the chin. An optional independent flow sensor can be placed in between the nasal cannula connection and the input line from a gas source. The flow sensor is only to detect the flow of whatever gas is passing through the source tube and serves no other function. If the flow sensor unit is attached and a flow is not detected, an alarm is provided. The alarm may be visual using the LED, an audible alarm, a vibration alarm, or a wireless signal which may be employed to notify the attending individual of an issue with flow. The flow sensor unit is not required for full functionality of the main body of the system and as an independent unit which simply unplugs from the flow line. 
     In accordance with yet another aspect of the invention, there is provided a nasal cannula clamp assembly including a circuit board, batteries, an activator switch, and an indicator. The circuitry processes data from the independent flow sensor (if installed) to monitor breathing and provides an alarm when a flow is not detected the system goes into standby mode until the flow issue is resolved. The alarm may be visual using the LED, audible, a vibration, or a wireless signal. The wireless signal may be transmit via Wi-Fi or other wireless protocols, and may be in the form of a text message. 
     In accordance with another aspect of the invention, there is provided a nasal cannula clamp assembly having clamps having a non-round interior cross-section. The interior cross-section may be parabolic, elliptical, oval, or any non-round shape. The clamps distort tubing in the clamps to grasp the tubing, and do not substantially collapse the tubing, thus not compromising the distribution of medication prescribed by the attending physician to the patient. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING 
       The above and other aspects, features and advantages of the present invention will be more apparent from the following more particular description thereof, presented in conjunction with the following drawings wherein: 
         FIG. 1  shows a patient wearing a nasal cannula system according to the present invention. 
         FIG. 1A  Shows the standard off shelf Nasal Cannula with the nasal cannula system and independent flow sensor according to the present invention. 
         FIG. 2A  shows a front view of the nasal cannula clamping system according to the present invention. 
         FIG. 2B  shows a rear view of the nasal cannula clamping system according to the present invention. 
         FIG. 2C  shows a side view of the nasal cannula clamping system according to the present invention. 
         FIG. 2D  shows a top view of the nasal cannula clamping system according to the present invention. 
         FIG. 3A  is a front and left side view of the clamping system according to the present invention. 
         FIG. 3B  is a rear and left side view of the nasal cannula clamping system according to the present invention. 
         FIG. 4  is an exploded view of the nasal cannula clamping system according to the present invention. 
         FIG. 4A  shows non-round passages according to the present invention. 
         FIG. 5A  is a front and right side perspective view of the nasal cannula clamp assembly according to the present invention. 
         FIG. 5B  is a rear and right side perspective view of the nasal cannula clamp assembly according to the present invention. 
         FIG. 5C  is a bottom, front, and right side perspective view of the nasal cannula clamp assembly according to the present invention. 
         FIG. 5D  is a bottom and right side perspective view of the nasal cannula clamp assembly according to the present invention. 
         FIG. 6A  is a front view of an independent flow sensor assembly of the nasal cannula clamping system according to the present invention. 
         FIG. 6B  is a rear and right side view of the independent flow sensor assembly of the nasal cannula clamping system according to the present invention. 
         FIG. 6C  is an exploded view of the independent flow sensor assembly of the nasal cannula clamping system according to the present invention. 
         FIG. 7  is a front view of the Nasal cannula clamping system according to the present invention with a biometric ear lobe clip sensor and independent flow sensor attached. 
         FIG. 8A  shows the nasal cannula clamping system including a flow sensor according to the present invention. 
         FIG. 8B  shows the nasal cannula clamping system without the flow sensor according to the present invention. 
       Corresponding reference characters indicate corresponding components throughout the several views of the drawings. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The following description is of the best mode presently contemplated for carrying out the invention. This description is not to be taken in a limiting sense, but is made merely for the purpose of describing one or more preferred embodiments of the invention. The scope of the invention should be determined with reference to the claims. 
     Where the terms “about” or “generally” are associated with an element of the invention, it is intended to describe a feature&#39;s appearance to the human eye or human perception, and not a precise measurement. 
     A patient  10  wearing a nasal cannular  14  (see  FIG. 1A ) secured by a nasal cannular clamping system  12  according to the present invention is shown in  FIG. 1 . The nasal cannular clamping system  12  is attached via non-round parallel passages/grooves  18   a  and  18   b  (see  FIG. 4A ) over second cannula tubes  14   b  under a patient chin, holding a nose piece  16  and over the ear tubes  14   b  of the cannula  14  in place. The cannula clamping system  12  includes the cannula clamp assembly  20 , the standard off the shelf cannula  14 , and a stand alone flow sensor unit  30  confirming flow to the cannula from a main source is shown in  FIG. 1A . 
     A front view of the Cannula clamping system  12  is shown in  FIG. 2A , a rear view of the Cannula clamping system  12  is shown in  FIG. 2B , a side view of the Cannula clamping system  12  is shown in  FIG. 2C , and a top view of the Cannula clamping system  12  is shown in  FIG. 2A . A front and left side view of the Cannula clamping system  12  is shown in  FIG. 3A  and a rear and left side view of the Cannula clamping system  12  is shown in  FIG. 3B . 
     An exploded view of the nasal cannula clamping system  12  is shown in  FIG. 4 . The Cannula clamp assembly  20  includes a clamp body  21  and a clamp block  22  for grasping the Cannula tubes  14   b.  A fastener, for example a lock screw)  24  passes through the block  22  and threads into the clamp body  21  to draw the clamp block  22 , guided by pins  23  in pin holes  23   a,  against the clamp body  21 , to grasp the Cannula tubes  14   b  between tube passages  18   a  and  18   b . A circuit board  27  and battery  26  reside in the clamp body  21  covered by a cover  25 . An indicator  29  is controlled by the circuit board  27  and a switch  28  controls the circuit board  27 . The indicator may be an optical indicator (e.g., and LED), an audio indicator, or a vibrating indicator, or a wireless signal  52  sent to device  54  (see  FIGS. 8A, 8B ). The wireless signal  52  may be transmit via WiFi or other wireless protocols, and may be in the form of a text message. 
     A cross-sectional view of the clamp block  22  against the clamp body  21  is shown in  FIG. 4A . The clamp block  22  includes non-round passages  18   a  and the clamp body  21  includes non-round passages  18   b.  The non-round passages  18   a  and  18   b  preferably and a width slightly greater than the diameter of the tubes  14   a  and  14   b,  a depth less than the radius of the tubes  14   a  and  14   b.  For example passages  18   a  and  18   b  for a standard adult cannula are preferably 0.129+0.001 or −0.002 inches wide and 0.059+0.0020 or −0.0010 inches deep. Passages  18   a  and  18   b  for a standard child cannula are preferably 0.088+0.0005 or −0.0010 inches wide and 0.040+0.0005 or −0.0010 inches deep. For other cannula tubes, the passages  18   a  and  18   b  are preferably between 0.005 and 0.002 inches wider than the tube diameter and between 0.0015 and 0.0045 shallower than the radius of the tube. The passages  18   a  and  18   b  are preferably smooth and more preferably are parabolic, elliptical, or oval shaped. 
     The optional flow sensor assembly  30  includes a sensor body  32 , a sensor cover  34  held against the sensor body  32  by screws  31 , and an O-Ring  35  between the sensor cover  34  and sensor body  32 . A flow sensor  39  resides in the sensor body  32  and a sensor circuit  36  and LED  33  receive power from batteries  38  internally wired to the circuit board  36  on the flow sensor unit to process signals from the flow sensor  39  and is covered by a circuit cover  37 . 
     The circuit board  27  processes data from the biometric sensors  42  (see  FIG. 7 ) to provide patient monitoring data and alerts. The patient monitoring data may be carried by led  40  or transmitted via WiFi or other wireless protocols directly to the WiFi or wireless network. The alerts may also be provided by the indicator multi color LED  29 . 
     A front and right side perspective view of the cannula clamp assembly  20  is shown in  FIG. 5A , a rear and right side perspective view of the cannula clamp assembly  20  is shown in  FIG. 5B , a bottom, front, and right side perspective view of the cannula clamp assembly  20  is shown in  FIG. 5C , and a bottom and right side perspective view of the cannula clamp assembly  20  is shown in  FIG. 5D . 
     A front view of a stand alone flow sensor assembly  30  is shown in  FIG. 6A , a rear and right side view of the flow sensor assembly  30  is shown in  FIG. 6B , and an exploded view of the flow sensor assembly  30  is shown in  FIG. 6C . 
     A front view of the nasal cannular clamping system  12  with a biometric sensor  42  attached by a lead  40  is shown in  FIG. 7 . The biometric sensor  42  may be a heart rate Beats Per Minute (BPM) sensor, a percentage of oxygen in blood sensor, or other biometric sensor. The biometric sensor  42  may be, for example, an ear clip sensor, but may be any other type of biometric sensor. Measurements from the biometric sensor  42  are provided to the circuit board  27  and processed to provide patient monitoring and alerts, via WiFi or other wireless protocols directly to the WiFi or wireless network  54  (see  FIGS. 8A and 8B ). 
       FIG. 8A  shows the nasal cannula clamping system including the flow sensor assembly  30 . Wireless sensor signals  50  are transmitted from the sensor circuit  36  in the flow sensor assembly  30  to the circuit board  27  in the cannula clamp assembly  20  validating that the flow is present in the tubing  14   a.  The signals are processed by the circuit board  27  and a wireless signal  52  is provided to monitoring  54  by a smart phone, a tablet, a personal computer, or specialized monitoring station. If the flow sensor assembly  30  is present and no flow is detected by the flow sensor assembly  30 , the signal  50  informs the circuit board  27  that no flow is present, and the wireless signal  52  is provided to monitoring  54  and the system goes to standby until the problem is corrected. If flow is detected, the system assumes a normal state of operation. 
       FIG. 8B  shows the nasal cannula clamping system without the flow sensor assembly  30 . When the flow sensor assembly  30  is not present, no signal  50  is sent and nothing occurs. 
     While the invention herein disclosed has been described by means of specific embodiments and applications thereof, numerous modifications and variations could be made thereto by those skilled in the art without departing from the scope of the invention set forth in the claims.