Pressure-Sensing Medical Devices, Systems and Methods, and Methods of Forming Medical Devices

Abstract

Medical devices, perfusion systems, and methods for detecting a pressure within a space in a subject and for perfusion of fluid into a space in a subject. The space may be a fluid-filled space, or a space that is depleted of fluid due to an obstruction to fluid flow into the space. Methods for forming the medical devices.

1 . A method comprising:
 forming an elongated body having a wall that defines a first lumen, a stiffener embedded in the wall, and a sensor lumen positioned in the wall, where the sensor lumen is not in direct fluid communication with the first lumen and does not impinge on the first lumen, the elongated body has a first end and a second end, and the first lumen extends from the first end to the second end such that both the first and second ends are open; and   positioning a sensor at least partially in the sensor lumen.   
     
     
         2 . The method of  claim 1 , where the sensor lumen is bounded, at least in part, by a liner. 
     
     
         3 . The method of  claim 2 , where the liner includes a polymer. 
     
     
         4 . The method of  claim 2 , where the liner includes a metal. 
     
     
         5 . The method of  claim 4 , where the forming includes heating a polymer that forms the wall. 
     
     
         6 . The method of  claim 5 , where the first lumen is shaped using a mandrel, and where the sensor lumen is shaped using another mandrel. 
     
     
         7 - 9 . (canceled) 
     
     
         10 . The method of  claim 1 , further comprising:
 securing the sensor to the elongated body such that the sensor can detect a parameter through an opening at the first end of the elongated body.   
     
     
         11 . (canceled) 
     
     
         12 . The method of  claim 1 , where the wall of the elongated body includes an opening that is proximal of the first end and that is in communication with the sensor lumen, the method further comprising:
 securing the sensor to the elongated body such that the sensor can detect a parameter through the opening of the wall of the elongated body.   
     
     
         13 - 14 . (canceled) 
     
     
         15 . The method of  claim 1 , where the wall has a wall thickness that is equal to or less than 600 microns at its greatest. 
     
     
         16 . The method of  claim 1 , where the sensor lumen is characterized by a longitudinal axis oriented parallel to and centered in at least a portion of the sensor lumen, and the sensor lumen has a dimension of no greater than 350 microns perpendicular to the longitudinal axis. 
     
     
         17 . The method of  claim 1 , further comprising:
 connecting a hub to the elongated body, the hub containing a first lumen in communication with the first lumen of the elongated body, a valve configured to seal the first lumen of the hub, and a second lumen in communication with the sensor lumen of the elongated body.   
     
     
         18 . The method of claim  7 , where the sensor is connected to a transmission line, and the positioning the sensor at least partially in the sensor lumen comprises positioning the sensor at least partially in the sensor lumen and positioning a portion of the transmission line in the sensor lumen, the method further comprising:
 connecting a hub to the elongated body, the hub containing a first lumen in communication with the first lumen of the elongated body, a valve configured to seal the first lumen of the hub, and a second lumen in communication with the sensor lumen of the elongated body; and   positioning a portion of the transmission line in the second lumen of the hub.   
     
     
         19 . The method of  claim 17 , where the hub further comprises a side port that includes the second lumen of the hub and that also includes a flushing lumen in communication with the first lumen of the hub. 
     
     
         20 . The method of  claim 1 , where the sensor lumen comprises a first sensor lumen and the elongated body that is formed includes a second sensor lumen positioned in the wall. 
     
     
         21 . The method of  claim 20 , where the sensor comprises a first sensor, and the method further comprises:
 positioning a second sensor at least partially in the second sensor lumen.   
     
     
         22 . The method of  claim 21 , where the elongated body has an inflatable balloon located proximal of the first end, and the wall of the elongated body includes an opening that is proximal of the inflatable balloon and that is in communication with the second sensor lumen, the method further comprising:
 securing the first sensor to the elongated body such that the first sensor can detect a parameter through an opening at the first end of the elongated body; and   securing a second sensor to the elongated body such that the second sensor can detect a parameter through the opening of the wall of the elongated body.   
     
     
         23 . The method of  claim 22 , further comprising:
 securing a third sensor to the elongated body such that the third sensor can detect a parameter within the inflatable balloon.   
     
     
         24 - 29 . (canceled) 
     
     
         30 . A method comprising:
 positioning one or more of:
 a first lumen mandrel; 
 a stiffener; 
 a second lumen mandrel; 
 a first lumen tube; 
 a second lumen tube; and 
 a shrink wrap material 
   such that the stiffener is outside of the first lumen mandrel, the first lumen tube is outside of the stiffener, the shrink wrap material is outside of the first lumen tube, and both the second lumen mandrel and the second lumen tube are inside of the shrink wrap material, thereby forming a combination;   heating the combination such that a melting temperature of the first lumen tube is reached and such that an activation temperature of the shrink wrap material is reached, the heating being sufficient to form an elongated body having a wall defining a first lumen, the elongated body also having a second lumen positioned in the wall;   after the heating, removing the second lumen mandrel leaving the second lumen formed at least in part by the second lumen tube; and   positioning a sensor at least partially in the second lumen;   where the elongated body has a first end and a second end, and the first lumen extends from the first end to the second end such that both the first and second ends are open.   
     
     
         31 . The method of  claim 30 , where the positioning includes positioning one or more of:
 a first lumen mandrel;   a stiffener;   a second lumen mandrel;   a first lumen tube;   a first liner tube;   a second lumen tube; and   a shrink wrap material   such that the stiffener is outside of the first lumen mandrel, the first lumen tube is outside of the stiffener, the first liner tube is inside the first lumen tube and outside the first lumen mandrel, the shrink wrap material is outside of the first lumen tube, and both the second lumen mandrel and the second lumen tube are inside of the shrink wrap material, thereby forming a combination.   
     
     
         32 - 56 . (canceled) 
     
     
         57 . A medical device comprising:
 an elongated body having a wall that defines a first lumen, a stiffener embedded in the wall, and a sensor lumen positioned in the wall; and   a sensor positioned at least partially in the sensor lumen;   where the sensor lumen is separate from the first lumen so as not to be in direct fluid communication with the first lumen and does not impinge on the first lumen, the elongated body has a first end and a second end, and the first lumen extends from the first end to the second end such that both the first and second ends are open.   
     
     
         58 . The medical device of  claim 57 , where the sensor lumen is bounded, at least in part, by a liner. 
     
     
         59 . The medical device of  claim 58 , where the liner includes a polymer. 
     
     
         60 . The medical device of  claim 58 , where the liner includes a metal. 
     
     
         61 . The medical device of  claim 60 , where the sensor is connected to a transmission line, a portion of which is positioned in the sensor lumen. 
     
     
         62 - 69 . (canceled) 
     
     
         70 . The medical device of  claim 61 , further comprising:
 a hub connected to the elongated body, the hub containing a first lumen in communication with the first lumen of the elongated body, a valve configured to seal the first lumen of the hub, and a second lumen in communication with the sensor lumen of the elongated body;   where a portion of the transmission line is positioned in the second lumen of the hub.   
     
     
         71 . (canceled) 
     
     
         72 . The medical device of  claim 57 , where the sensor lumen comprises a first sensor lumen and the elongated body includes a second sensor lumen positioned in the wall. 
     
     
         73 . The medical device of  claim 72 , where the sensor comprises a first sensor, and the medical device further comprises:
 a second sensor positioned at least partially in the second sensor lumen.   
     
     
         74 . The medical device of  claim 73 , where the elongated body has an inflatable balloon located proximal of the first end, the wall of the elongated body includes an opening that is proximal of the inflatable balloon and that is in communication with the second sensor lumen, and the first sensor is secured to the elongated body such that the first sensor can detect a parameter through an opening at the first end of the elongated body, the medical device further comprising:
 a second sensor secured to the elongated body such that the second sensor can detect a parameter through the opening of the wall of the elongated body.   
     
     
         75 . The medical device of  claim 74 , further comprising:
 a third sensor secured to the elongated body such that the third sensor can detect a parameter within the inflatable balloon.   
     
     
         76 - 81 . (canceled) 
     
     
         82 . A medical device comprising:
 a body configured as a hub for connection to an elongated tube, the body including a primary lumen, a side arm that includes a flushing lumen that is in direct fluid communication with the primary lumen, and an embedded transmission line that is not in direct fluid communication with the flushing lumen or the primary lumen within the body; and   a valve configured to seal the primary lumen.   
     
     
         83 . The medical device of  claim 82 , where a portion of the transmission line is embedded in the side arm. 
     
     
         84 . The medical device of  claim 82 , where the body includes a second side arm, and a portion of the transmission line is embedded in the second side arm. 
     
     
         85 . (canceled) 
     
     
         86 . A medical device comprising:
 an elongated body having a passageway, a distal end, and a proximal end; and   a pressure sensor attached to the elongated body, the pressure sensor having a length along any axis that is not greater than 2 mm, the pressure sensor being configured to detect a fluid pressure and output one or more signals representative of the detected fluid pressure   where the elongated body includes a region that thermally insulates the passageway.   
     
     
         87 - 113 . (canceled)