Methods and devices for sensing respiration and providing ventilation therapy

Abstract

Methods and systems are provided for intra-airway breath sensors where intra-airway breath sensors are not located within a ventilation gas delivery circuit, but are exposed to spontaneous respiration airflow from a patient. Furthermore, methods and systems of the present invention may be used to protect an intra-airway breath sensor from contacting tissue or accumulating debris that may impair abilities of the intra-airway breath sensors.

1 . A breath sensing and ventilation delivery apparatus comprising:
 a catheter,   one or more intra-airway breath sensors coupled to an outer surface of the catheter, and   an airflow permeable protector with a proximal end adapted to be positioned outside a patient and a distal end adapted to be placed in an airway of the patient, wherein the airflow permeable protector at least partially surrounds the catheter such that the airflow permeable protector prevents the one or more intra-airway breath sensors from contacting a tissue and reduces accumulation of debris on the one or more intra-airway breath sensors.   
   
   
       2 . The apparatus of  claim 1 , wherein the airflow permeable protector is a tracheostomy tube cannula. 
   
   
       3 . The apparatus of  claim 2 , wherein the cannula has one or more fenestrations. 
   
   
       4 . The apparatus of  claim 2 , wherein the cannula at least partially surrounds the catheter forming an annular space between the cannula and the catheter. 
   
   
       5 . The apparatus of  claim 1 , wherein the airflow permeable protector is a protective shield. 
   
   
       6 . The apparatus of  claim 5 , wherein the protective shield is selected from the group consisting of a shield tapered on at least one end, a shield collapsible against an outer surface of the ventilation catheter, stoma sleeve, and combinations thereof. 
   
   
       7 . The apparatus of  claim 1 , wherein the one or more intra-airway breath sensors are selected from the group consisting of thermal sensors, pressure sensors, pressure sensing lumen, gas composition sensors, flow sensors, ultrasonic sensors, resistivity sensors, piezoelectric sensors, light emittance/reflectance sensors, and combinations thereof. 
   
   
       8 . A breath sensing and ventilation delivery apparatus comprising:
 a ventilation catheter,   a tracheostomy tube cannula with one or more fenestrations, wherein the cannula at least partially surrounds the ventilation catheter to create an annular space between an inner diameter of the cannula and an outer diameter of the ventilation catheter, and   one or more intra-airway breath sensors within the annular space between an inner diameter of the cannula and an outer diameter of the ventilation catheter.   
   
   
       9 . The apparatus of  claim 8 , wherein the ventilation catheter extends beyond a distal portion of the cannula and into an airway. 
   
   
       10 . The apparatus of  claim 8 , further comprising a positioner for positioning the ventilation catheter at a predetermined position within the cannula. 
   
   
       11 . The apparatus of  claim 10 , wherein the positioner is basket-type device. 
   
   
       12 . The apparatus of  claim 10 , wherein the positioner is a deflector in a wall of the cannula. 
   
   
       13 . The apparatus of  claim 8 , further comprising an anchor for preventing movement of a distal tip of the ventilation catheter. 
   
   
       14 . The apparatus of  claim 8 , wherein the one or more fenestrations are located in a position selected from the group consisting of a superior side of the cannula, an inferior side of the cannula, a lateral side of the outer cannula, and combinations thereof. 
   
   
       15 . The apparatus of  claim 8 , wherein the one or more intra-airway breath sensors are selected from the group consisting of thermal sensors, pressure sensors, pressure sensing lumen, tubes with sensing lumen, sensing subassemblies, gas composition sensors, flow sensors, ultrasonic sensors, resistivity sensors, piezoelectric sensors, light emittance/reflectance sensors, and combinations thereof. 
   
   
       16 . The apparatus of  claim 8 , wherein the one or more intra-airway breath sensors are multiple elements placed in an array, wherein one element is used as a reference signal. 
   
   
       17 . The apparatus of  claim 8 , wherein the one or more intra-airway breath sensors are coupled to the ventilation catheter. 
   
   
       18 . The apparatus of  claim 8 , wherein the one or more intra-airway breath sensors are coupled to the cannula. 
   
   
       19 . The apparatus of  claim 8 , wherein the one or more intra-airway breath sensors are de-coupled from the ventilation catheter and the cannula. 
   
   
       20 . The apparatus of  claim 8 , wherein the one or more intra-airway breath sensors are a sensing lumen not in communication with a ventilation catheter gas delivery circuit, wherein the sensing lumen comprises a sensing element and a port positioned in the annular space and wherein the sensing element is located external to a body and communicating with the sensing lumen. 
   
   
       21 . The apparatus of  claim 8 , wherein the ventilation catheter is removable from the cannula. 
   
   
       22 . The apparatus of  claim 8 , further comprising a seal between the cannula and the ventilation catheter at a location proximal to the one or more intra-airway breath sensors. 
   
   
       23 . The apparatus of  claim 8 , wherein the ventilation catheter comprises a moveable connection with the cannula. 
   
   
       24 . A breath sensing and ventilation delivery apparatus comprising:
 (a) a tubular member with a proximal end and a distal end, wherein the proximal end is adapted to be positioned outside a patient and the distal end is adapted to be positioned in an airway of the patient, wherein the tubular member includes one or more fenestrations, wherein spontaneous respiration by a patient passes through the one or more fenestrations,   (b) one or more intra-airway breath sensors within a lumen of the tubular member, wherein a distal end portion of the tubular member is positioned in the airway such that the one or more intra-airway breath sensors are located within the airway, and   wherein the one or more intra-airway breath sensors are exposed to the spontaneous respiration by the patient while within the airway.   
   
   
       25 . The apparatus of  claim 24 , wherein the one or more fenestrations are located in a position selected from the group consisting of a superior side of the tubular member, an inferior side of the tubular member, a lateral side of the tubular member, and combinations thereof. 
   
   
       26 . The apparatus of  claim 24 , wherein the one or more intra-airway breath sensors are selected from the group consisting of thermal sensors, pressure sensors, pressure sensing lumen, tubes with sensing lumen, sensing subassemblies, gas composition sensors, flow sensors, ultrasonic sensors, resistivity sensors, piezoelectric sensors, light emittance/reflectance sensors, and combinations thereof. 
   
   
       27 . A breath sensing and ventilation delivery apparatus comprising:
 (a) a ventilation catheter for ventilation gas delivery including at least one breath sensing lumen including a breath sensing lumen port,   (b) an airflow permeable protector at least partially surrounding a portion of the catheter to protect the at least one breath sensing lumen port,   (c) a connection to connect the at least one breath sensing lumen to an external sensor, and further wherein the catheter is configured to be placed into an airway of the patient to position the at least one breath sensing lumen port and permeable protector in the airway, and wherein the at least on breath sensing lumen port is protected by the airflow permable protector but is exposed to spontaneous airflow in the airway.   
   
   
       28 . The apparatus of  claim 27 , wherein the airflow permeable protector comprises one or more fenestrations, which are located in a position selected from the group consisting of a superior side of the airflow permeable protector, an inferior side of the airflow permeable protector, a lateral side of the airflow permeable protector, and combinations thereof. 
   
   
       29 . The apparatus of  claim 27 , wherein the external sensor is selected from the group consisting of thermal sensors, gas composition sensors, flow sensors, ultrasonic sensors, resistivity sensors, piezoelectric sensors, light emittance/reflectance sensors, and combinations thereof. 
   
   
       30 . A breath sensing and ventilation catheter apparatus comprising:
 a ventilation catheter for ventilation gas delivery,   at least one breath sensing lumen port positioned on an outside surface of the ventilation catheter,   an airflow permeable shield at least partially surrounding the at least one breath sensing lumen port, and   wherein the airflow permeable shield prevents contact of the at least one breath sensing lumen port with tissue and reduces accumulation of debris on the at least one breath sensing lumen port.   
   
   
       31 . The apparatus of  claim 30 , wherein the airflow permeable shield is a collapsible basket. 
   
   
       32 . The apparatus of  claim 30 , wherein the airflow permeable shield is a cone tapering from a proximal end to a distal end, and wherein the cone further comprises one or more fenestrations. 
   
   
       33 . The apparatus of  claim 30 , wherein the airflow permeable shield is a cuff. 
   
   
       34 . The apparatus of  claim 30 , wherein the airflow permeable shield is a stoma sleeve. 
   
   
       35 . The apparatus of  claim 30 , wherein the airflow permeable shield is collapsible against an outer surface of the ventilation catheter. 
   
   
       36 . The apparatus of  claim 30 , wherein the at least one breath sensing lumen port is connected to a sensor external to a patient, the sensor selected from the group consisting of thermal sensors, pressure sensors, gas composition sensors, flow sensors, ultrasonic sensors, resistivity sensors, piezoelectric sensors, light emittance/reflectance sensors, and combinations thereof. 
   
   
       37 . A method for breath sensing and ventilation comprising:
 inserting at least one intra-airway breath sensor into a tubular guide positioned with a proximal end adapted to be outside of the patient and a distal end adapted to be inside an airway of a patient,   wherein the at least one intra-airway breath sensor is not located within a ventilator gas flow, and   wherein the at least one intra-airway breath sensor is shielded from contacting tissue and from accumulating debris by the tubular guide.   
   
   
       38 . The method of  claim 37 , wherein the tubular guide is a tracheostomy tube cannula. 
   
   
       39 . The method of  claim 38 , wherein the cannula at least partially surrounds a ventilation catheter for providing the ventilator gas flow, wherein the cannula forms an annular space between the cannula and the ventilation catheter. 
   
   
       40 . The method of  claim 39 , wherein the at least one intra-airway breath sensor is within the annular space. 
   
   
       41 . The method of  claim 38 , wherein the cannula has one or more fenestrations. 
   
   
       42 . The method of  claim 37 , wherein the tubular guide is a protective shield. 
   
   
       43 . The method of  claim 42 , wherein the protective shield is selected from the group consisting of a shield tapered on at least one end, a shield collapsible against an outer surface of the ventilation catheter, stoma sleeve, and combinations thereof. 
   
   
       44 . The method of  claim 37 , wherein the at least one intra-airway breath sensor is selected from the group consisting of thermal sensors, pressure sensors, pressure sensing lumen, gas composition sensors, flow sensors, ultrasonic sensors, resistivity sensors, piezoelectric sensors, light emittance/reflectance sensors, and combinations thereof. 
   
   
       45 . A method for breath sensing and ventilation comprising:
 inserting at least one intra-airway breath sensor in a path of a patient's airway airflow, but not within a ventilation gas delivery circuit,   monitoring the patient's airway airflow with the at least one intra-airway breath sensor,   operating at least one ventilation gas sensor within a ventilation gas delivery circuit, and   monitoring the ventilator gas delivery with the at least one ventilation gas sensor simultaneous with monitoring the patient's airway airflow with the at least one intra-airway breath sensor.   
   
   
       46 . The method of  claim 45 , wherein the at least one intra-airway breath sensor is coupled to a ventilation catheter. 
   
   
       47 . The method of  claim 45 , wherein the at least one intra-airway breath sensor is at least partially surrounded by a protector. 
   
   
       48 . The method of  claim 47 , wherein the protector is a tracheostomy tube cannula. 
   
   
       49 . The method of  claim 48 , wherein the cannula comprises one or more fenestrations. 
   
   
       50 . The method of  claim 47 , wherein the protector is an airflow permeable shield. 
   
   
       51 . The method of  claim 50 , wherein the airflow permeable shield is selected from the group consisting of a basket, a cone, a cuff, a grouping of wires or filaments, a shield tapered on at least one end, a shield collapsible against an outer surface of the ventilation catheter, stoma sleeve, and combinations thereof. 
   
   
       52 . The method of  claim 45 , wherein the at least one intra-airway breath sensor is selected from the group consisting of thermal sensors, pressure sensors, pressure sensing lumen, gas composition sensors, flow sensors, ultrasonic sensors, resistivity sensors, piezoelectric sensors, light emittance/reflectance sensors, and combinations thereof. 
   
   
       53 . An apparatus for breath sensing and ventilation comprising:
 a ventilation catheter for supplying ventilation gas to a patient via a ventilation gas delivery channel in the catheter,   a sensing conduit not in communication with the ventilation catheter gas delivery circuit,   an opening in the sensing conduit for sensing respiration of the patient through the sensing conduit when the opening is positioned within an airway, and   a sensing element communicating with the sensing conduit for sensing respiration of the patient, wherein the sensing element is located external to the patient, and   a protector at least partially surrounding the ventilation catheter and sensing conduit opening.   
   
   
       54 . The apparatus of  claim 53 , wherein the protector is a tracheostomy tube cannula. 
   
   
       55 . The apparatus of  claim 54 , wherein the cannula comprises one or more fenestrations. 
   
   
       56 . The apparatus of  claim 55 , wherein the sensing element is selected from the group consisting of: a pressure sensor, a flow sensor, a thermal sensor, or an ultrasonic sensor. 
   
   
       57 . The apparatus of  claim 56 , wherein the protector is selected from the group consisting of a basket, a cone, a cuff, a grouping of wires or filaments, a shield tapered on at least one end, a shield collapsible against an outer surface of the ventilation catheter, stoma sleeve, and combinations thereof. 
   
   
       58 . A breath sensing and ventilation delivery apparatus comprising:
 a ventilation catheter,   a tracheostomy tube cannula, wherein the tube cannula at least partially surrounds the ventilation catheter to create an annular space between an inner diameter of the cannula and an outer diameter of the ventilation catheter, and   one or more intra-airway breath sensors within the annular space between an inner diameter of the cannula and an outer diameter of the ventilation catheter.   
   
   
       59 . The apparatus of  claim 58 , wherein the one or more intra-airway breath sensors are coupled to the ventilation catheter. 
   
   
       60 . The apparatus of  claim 58 , wherein the one or more intra-airway breath sensors are coupled to the cannula. 
   
   
       61 . The apparatus of  claim 58 , wherein the one or more intra-airway breath sensors are de-coupled from the ventilation catheter and the outer cannula. 
   
   
       62 . The apparatus of  claim 58 , wherein the at least one intra-airway breath sensor is selected from the group consisting of thermal sensors, pressure sensors, pressure sensing lumen, gas composition sensors, flow sensors, ultrasonic sensors, resistivity sensors, piezoelectric sensors, light emittance/reflectance sensors, and combinations thereof. 
   
   
       63 . A breath sensing and ventilation delivery apparatus comprising:
 (a) a ventilation catheter including a ventilation gas delivery channel and a breath sensing lumen, wherein the breath sensing lumen includes a sensing port, and wherein the ventilation catheter is configured to be placed into the lumen of a tracheostomy tube such that the ventilation catheter is at least partially surrounded by the tracheostomy tube to prevent the sensing port from contacting the tracheal wall; and   (b) a breath sensor external to the patient communicating with the breath sensing lumen.   
   
   
       64 . A breath sensing and ventilation delivery apparatus as in  claim 63 , wherein the external breath sensor is a pressure sensor. 
   
   
       65 . A breath sensing and ventilation delivery apparatus as in  claim 63 , wherein the ventilation gas delivery channel is connected to a flow or pressure sensor external to the patient. 
   
   
       66 . A breath sensing and ventilation delivery apparatus as in  claim 63 , wherein the tracheostomy tube is a cannula of a dual cannula tracheostomy tube. 
   
   
       67 . A breath sensing and ventilation delivery apparatus as in  claim 63 , wherein the tracheostomy tube is a single cannula tube. 
   
   
       68 . A breath sensing and ventilation delivery apparatus as in  claim 63 , wherein the ventilation catheter has a locking connector to connect to the tracheostomy tube 
   
   
       69 . A breath sensing and ventilation delivery apparatus as in  claim 63 , wherein the tracheostomy tube has a fenestration positioned in the airway. 
   
   
       70 . A breath sensing and ventilation delivery apparatus as in  claim 63 , wherein the ventilation catheter has a centering feature to prevent the sensing port from touching the inner wall of the tracheostomy tube. 
   
   
       71 . A breath sensing and ventilation delivery apparatus as in  claim 63  wherein the sensing port is positioned at a distance away from the distal end of the ventilation catheter. 
   
   
       72 . A breath sensing and ventilation delivery apparatus comprising:
 (a) a ventilation catheter including (i) a ventilation gas delivery channel, (ii) a breath sensing lumen including a sensing port, (iii) an airflow permeable shield at least partially surrounding the sensing port;   (b) a breath sensor placed external to the patient communicating with the breath sensing lumen, wherein the catheter is configured to be placed into an airway of a patient such that the sensing port and at least a portion of the airflow permeable shield is positioned in the airway of the patient such that the airflow permeable shield prevents the sensing port from contacting the airway wall, and such that the sensing port is exposed to airflow in the airway.   
   
   
       73 . A breath sensing and ventilation delivery apparatus as in  claim 72  wherein the external breath sensor is a pressure sensor. 
   
   
       74 . A breath sensing and ventilation delivery apparatus as in  claim 72  wherein the ventilation gas delivery channel is connected to a flow or pressure sensor external to the patient. 
   
   
       75 . A breath sensing and ventilation delivery apparatus as in  claim 72  wherein the sensing port is positioned at a distance away from the distal end of the ventilation catheter. 
   
   
       76 . A breath sensing and ventilation delivery apparatus as in  claim 72  wherein the ventilation catheter is configured to be placed in through a stoma guide. 
   
   
       77 . A breath sensing and ventilation delivery apparatus as in  claim 72  wherein the airflow permeable shield is collapsible. 
   
   
       78 . A method for breath sensing and ventilation delivery comprising:
 inserting a one end of a ventilation catheter into a tracheostomy tube of a patient, wherein the ventilation catheter includes a gas delivery channel, and a breath sensing lumen and a breath sensing lumen port, and   connecting at a second end of the ventilation catheter the gas delivery channel to a ventilation gas source and the breath sensing lumen to a breath sensor element.   
   
   
       79 . A method as in  claim 78 , wherein step of connecting includes connecting to the external breath sensor that is a pressure sensor. 
   
   
       80 . A method as in  claim 78 , wherein the step of connecting includes connecting the ventilation gas delivery channel to a flow or pressure sensor external to the patient. 
   
   
       81 . A method as in  claim 78 , further comprising the step of connecting the ventilation catheter having a locking connector to the tracheostomy tube. 
   
   
       82 . A method as in  claim 78 , further comprising the step of positioning a fenestration in the tracheostomy tube in the airway. 
   
   
       83 . A method as in  claim 78 , further comprising the step of centering the ventilation catheter using a centering feature on the ventilation catheter to prevent the sensing port from touching the inner wall of the tracheostomy tube. 
   
   
       84 . A method as in  claim 78 , further comprising the step of positioning the sensing port at a distance away from the distal end of the ventilation catheter. 
   
   
       85 . A method for breath sensing and ventilation delivery comprising:
 inserting a one end of a ventilation catheter through a stoma and into an airway of a patient, wherein the ventilation catheter includes a gas delivery channel a breath sensing lumen and a breath sensing lumen port, and a protective shield at least partially surrounding the catheter section inserted into the airway to prevent the sensing lumen port from contacting the airway wall, and   connecting, at a second end of the ventilation catheter, the gas delivery channel to a ventilation gas source and the breath sensing lumen to a breath sensor element.   
   
   
       86 . A method as in  claim 85 , wherein the step of connecting includes connecting to the external breath sensor is a pressure sensor. 
   
   
       87 . A method as in  claim 85 , wherein the step of connecting includes connecting the ventilation gas delivery channel to a flow or pressure sensor external to the patient. 
   
   
       88 . A method as in  claim 85 , further comprising the step of positioning the sensing port at a distance away from the distal end of the ventilation catheter. 
   
   
       89 . A method as in  claim 85 , further comprising the step of positioning the ventilation catheter through a stoma guide. 
   
   
       90 . A method as in  claim 85 , wherein the step of inserting includes inserting the airflow permeable shield that is collapsible.