Medical apparatus with translatable imaging device for real-time confirmation of interception of target tissue

Abstract

A medical apparatus includes a catheter, a medical instrument assembly, and an imaging assembly. The catheter having a first working channel terminating with a first distal exit, and a second working channel extending terminating with a second distal exit. The medical instrument assembly having a medical instrument adapted to be housed within the first working channel and adapted to be extendable through the first distal exit to an extended position beyond the first distal exit to intercept a target tissue. The imaging assembly includes an imaging device adapted to be housed within the second working channel and is extendable through the second distal exit to an extended position beyond the second distal exit. The imaging device is adapted to generate an image in an image plane of the distal end of the medical instrument when the distal end of the medical instrument is extended out the first distal exit.

What is claimed: 
     
         1 . A medical apparatus, comprising:
 a catheter comprising a first elongate flexible shaft having a proximal end portion, a distal end portion, the proximal end portion comprising a first port and a second port, the distal end portion comprising a first distal exit and a second distal exit, wherein a first working channel extends between the first port and the first distal exit, and a second working channel extends between the second port and the second distal exit;   a medical instrument assembly comprising a medical instrument, wherein the medical instrument has a proximal end and a distal end and is adapted to be housed within the first working channel, and wherein the distal end of the medical instrument is extendable through the first distal exit to an extended position beyond the first distal exit; and   an imaging assembly comprising a second elongate flexible shaft having a proximal end portion and a distal end portion, and an imaging device affixed the distal end portion of the second elongate flexible shaft, the imaging device adapted to be housed within the second working channel and wherein the imaging device is extendable through the second distal exit to an extended position beyond the second distal exit, wherein the imaging device is adapted to generate an image in an image plane of the distal end of the medical instrument when the distal end of the medical instrument is extended out the first distal exit.   
     
     
         2 . The medical apparatus of  claim 1 , wherein the medical instrument is adapted to intercept a target tissue proximate an airway of a patient and wherein the imaging device is adapted to be extended along an airway branch proximate the target tissue, and wherein the image of the distal end of the medical instrument is generated from with the airway branch. 
     
     
         3 . The medical apparatus of  claim 1 , wherein the imaging device is a radial endobronchial ultrasound (EBUS) transducer or an optical coherence tomography (OCT) device. 
     
     
         4 . The medical apparatus of  claim 1 , wherein the medical instrument comprises a needle, an ablation probe, a biopsy device, a forceps device, a brush, an auger, a stylet, an energy delivery device, a therapy delivery device, a cryotherapy device, a laser device, a microwave device, a diffuse infrared laser device, a laser device, a microwave device, or a steam ablation device. 
     
     
         5 . The medical apparatus of  claim 1 , wherein the medical instrument assembly further comprises:
 a handle assembly having a first end and a second end, the handle assembly comprising a first handle portion proximate the first end and a second handle portion proximate the second end, wherein the second handle portion is slidably engaged with the first handle portion;   a first localization element attached to the first handle portion; and   a second localization element attached to the second handle portion;   wherein the proximal end of the medical instrument is mechanically coupled to the second handle portion and wherein a translation of second handle portion with respect to the first handle portion causes a coincident and coextensive translation of the medical instrument.   
     
     
         6 . The medical apparatus of  claim 5 , wherein the first and second localization elements are adapted to be coupled to a processor and adapted to send to the processor information associated with a first position in three-dimensional space of the first localization element and information associated with a second position in three-dimensional space of the second localization element. 
     
     
         7 . The medical apparatus of  claim 6 , wherein the amount of translation of the medical instrument is adapted to be determined by calculating the distance between the first position of the first localization element and the second position of the second localization element. 
     
     
         8 . The medical apparatus of  claim 1 , wherein the imaging assembly further comprises:
 a handle assembly having a first end and a second end, the handle assembly comprising a first handle portion proximate the first end and a second handle portion proximate the second end, wherein the second handle portion is slidably engaged with the first handle portion;   a first localization element attached to the first handle portion; and   a second localization element attached to the second handle portion;   wherein the imaging assembly is mechanically coupled to the second handle portion and wherein a translation of second handle portion with respect to the first handle portion causes a coincident and coextensive translation of the imaging device.   
     
     
         9 . The medical apparatus of  claim 8 , wherein the first and second localization elements are adapted to be coupled to a processor and adapted to send to the processor information associated with a first position in three-dimensional space of the first localization element and information associated with a second position in three-dimensional space of the second localization element, and wherein the processor is adapted to receive a population of images generated by the imaging device, and wherein the distance between the population of images is adapted to be determined by the processor by calculating the distance between the first position of the first localization element and the second position of the second localization element for each of the population of images. 
     
     
         10 . A medical apparatus, comprising:
 a catheter comprising a first elongate flexible shaft having a proximal end portion, a distal end portion, and a longitudinal axis extending from the proximal end portion to the distal end portion, the proximal end portion comprising a first port and a second port, the distal end portion comprising a side exit and a distal exit, wherein a first working channel extends between the first port and the side exit, and a second working channel extends between the second port and the distal exit;   a medical instrument assembly comprising a medical instrument, wherein the medical instrument has a proximal end and a distal end and is adapted to be housed within the first working channel, and wherein the distal end of the medical instrument is extendable along a path from a position within the elongate flexible shaft and through the side exit to an extended position outside the elongate flexible shaft at an angle Θ relative to the longitudinal axis of the first elongate flexible shaft; and   an imaging assembly comprising a second elongate flexible shaft having a proximal end portion and a distal end portion, and an imaging device affixed to the distal end portion of the second elongate flexible shaft, the imaging device adapted to be translated within the second working channel and adapted to generate an image in an image plane of the distal end of the medical instrument when the distal end of the medical instrument is extended out the side exit, wherein the imaging plane of the imaging device is adapted to be oriented substantially at the angle Θ at which the medical instrument extends out the first exit.   
     
     
         11 . The medical apparatus of  claim 10 , wherein the generated image further includes an image of a portion of a target intercepted by the medical instrument. 
     
     
         12 . The medical apparatus of  claim 10 , wherein the imaging device is a radial endobronchial ultrasound (EBUS) transducer or an optical coherence tomography (OCT) device. 
     
     
         13 . The medical apparatus of  claim 10 , wherein the medical instrument comprises a needle, an ablation probe, a biopsy device, a forceps device, a brush, an auger, a stylet, an energy delivery device, a therapy delivery device, a cryotherapy device, a laser device, a microwave device, a diffuse infrared laser device, a laser device, a microwave device, or a steam ablation device. 
     
     
         14 . The medical apparatus of  claim 14 , wherein the medical instrument assembly further comprises:
 a handle assembly having a first end and a second end, the handle assembly comprising a first handle portion proximate the first end and a second handle portion proximate the second end, wherein the second handle portion is slidably engaged with the first handle portion;   a first localization element attached to the first handle portion; and   a second localization element attached to the second handle portion;   wherein the proximal end of the medical instrument is mechanically coupled to the second handle portion and wherein a translation of second handle portion with respect to the first handle portion causes a coincident and coextensive translation of the medical instrument.   
     
     
         15 . The medical apparatus of  claim 14 , wherein the first and second localization elements are adapted to be coupled to a processor and adapted to send to the processor information associated with a first position in three-dimensional space of the first localization element and information associated with a second position in three-dimensional space of the second localization element. 
     
     
         16 . The medical apparatus of  claim 15 , wherein the amount of translation of the medical instrument is adapted to be determined by calculating the distance between the first position of the first localization element and the second position of the second localization element. 
     
     
         17 . The medical apparatus of  claim 10 , wherein the imaging assembly further comprises:
 a handle assembly having a first end and a second end, the handle assembly comprising a first handle portion proximate the first end and a second handle portion proximate the second end, wherein the second handle portion is slidably engaged with the first handle portion;   a first localization element attached to the first handle portion; and   a second localization element attached to the second handle portion;   wherein the imaging assembly is mechanically coupled to the second handle portion and wherein a translation of second handle portion with respect to the first handle portion causes a coincident and coextensive translation of the imaging device.   
     
     
         18 . The medical apparatus of  claim 17 , wherein the first and second localization elements are adapted to be coupled to a processor and adapted to send to the processor information associated with a first position in three-dimensional space of the first localization element and information associated with a second position in three-dimensional space of the second localization element, and wherein the processor is adapted to receive a population of images generated by the imaging device, and wherein the distance between the population of images is adapted to be determined by the processor by calculating the distance between the first position of the first localization element and the second position of the second localization element for each of the population of images. 
     
     
         19 . A method of generating an image of a medical instrument comprising:
 navigating a medical apparatus through an airway of a patient to a position proximate a target, the medical apparatus comprising a catheter, a medical instrument assembly, and an imaging assembly;
 wherein the catheter comprises an elongate flexible shaft having a proximal end portion and a distal end portion, the proximal end portion comprising a first port and a second port, the distal end portion comprising a first distal exit and a second distal exit, wherein a first working channel extends between the first port and the first distal exit, and a second working channel extends between the second port and the second distal exit; 
 wherein the medical instrument assembly comprises a medical instrument, the medical instrument having a proximal end and a distal end and housed within the first working channel, wherein the distal end of the medical instrument is extendable through the first distal exit to an extended position beyond the first distal exit; and 
 wherein the imaging assembly comprises a second elongate flexible shaft having a proximal end portion and a distal end portion, and an imaging device affixed the distal end portion of the second elongate flexible shaft, the imaging device housed within the second working channel and wherein the imaging device is extendable through the second distal exit to an extended position beyond the second distal exit; 
   extending at least a portion of the medical instrument from within the first working channel out through the first distal exit;   extending the imaging device from within the second working channel out through the second distal exit; and   generating an image of at least a portion of the medical instrument extended out the first distal exit using the imaging device.   
     
     
         20 . The method of  claim 19  further comprising:
 altering the extension of the imaging device out the second distal exit; and 
 generating an additional image of at least a portion of the medical instrument extended out the first exit. 
 
     
     
         21 . The method of  claim 19  further comprising:
 inserting at least a portion of the medical instrument into the target proximate the airway of the patient; 
 extending the imaging device along a first branch of the airway proximate the target; and 
 generating a first image of at least the portion of the medical instrument and the target as the as the medical instrument is inserted into the target. 
 
     
     
         22 . The method of  claim 21 , further comprising:
 receiving, by a processor coupled to the imaging device, the image generated by the imaging device; and   saving, by the processor, the image to a file.   
     
     
         23 . The method of  claim 21 , further comprising, while at least the portion of the medical instrument is inserted into the target:
 extending the imaging device along a second branch of the airway proximate the target; and   generating a second image of at least the portion of the medical instrument and the target as the as the medical instrument is inserted into the target, wherein the first image depicts a first side of the target and the second image depicts a second side of the target.   
     
     
         24 . The method of  claim 19 , wherein the imaging device is a radial endobronchial ultrasound (EBUS) transducer or an optical coherence tomography (OCT) device. 
     
     
         25 . The method of  claim 19 , wherein the medical instrument comprises a needle, an ablation probe, a biopsy device, a forceps device, a brush, an auger, a stylet, an energy delivery device, a therapy delivery device, a cryotherapy device, a laser device, a microwave device, a diffuse infrared laser device, a laser device, a microwave device, or a steam ablation device. 
     
     
         26 . The method of  claim 19 , wherein the medical instrument assembly further comprises:
 a handle assembly having a first end and a second end, the handle assembly comprising a first handle portion proximate the first end and a second handle portion proximate the second end, wherein the second handle portion is slidably engaged with the first handle portion;   a first localization element attached to the first handle portion; and   a second localization element attached to the second handle portion;   wherein the proximal end of the medical instrument is mechanically coupled to the second handle portion and wherein a translation of second handle portion with respect to the first handle portion causes a coincident and coextensive translation of the medical instrument.   
     
     
         27 . The method of  claim 26 , wherein the first and second localization elements are coupled to a processor and the method further comprises sending, to the processor, information associated with a first position in three-dimensional space of the first localization element and information associated with a second position in three-dimensional space of the second localization element. 
     
     
         28 . The method of  claim 27 , further comprising determining the amount of translation of the medical instrument by calculating, by the processor, the distance between the first position of the first localization element and the second position of the second localization element. 
     
     
         29 . The method of  claim 19 , wherein the imaging assembly further comprises:
 a handle assembly having a first end and a second end, the handle assembly comprising a first handle portion proximate the first end and a second handle portion proximate the second end, wherein the second handle portion is slidably engaged with the first handle portion;   a first localization element attached to the first handle portion; and   a second localization element attached to the second handle portion;   wherein the imaging assembly is mechanically coupled to the second handle portion and wherein a translation of second handle portion with respect to the first handle portion causes a coincident and coextensive translation of the imaging device.   
     
     
         30 . The method of  claim 29 , wherein the first and second localization elements are coupled to a processor and the method further comprises:
 sending, to the processor, information associated with a first position in three-dimensional space of the first localization element and information associated with a second position in three-dimensional space of the second localization element;   receiving, by the processor, a population of images generated by the imaging device; and   determining, by the processor, the distance between the population of images by calculating the distance between the first position of the first localization element and the second position of the second localization element for each of the population of images.   
     
     
         31 . The method of  claim 19 , further comprising:
 receiving, by a processor, a population of images generated by the imaging device; and   displaying on a display coupled to the processor, one or more of the population of images received by the processor from the imaging device.   
     
     
         32 . A method of generating an image of a medical instrument comprising:
 navigating a medical apparatus through an airway of a patient to a position proximate a target, the medical apparatus comprising a catheter, a medical instrument assembly, and an imaging assembly;
 wherein the catheter comprises an elongate flexible shaft having a proximal end portion, a distal end portion, and a longitudinal axis extending from the proximal end portion to the distal end portion, the proximal end portion comprising a first port and a second port, the distal end portion comprising a side exit and a distal exit, wherein a first working channel extends between the first port and the side exit, and a second working channel extends between the second port and the distal exit; 
 wherein the medical instrument assembly comprises a medical instrument, the medical instrument having a proximal end and a distal end and housed within the first working channel, wherein the distal end of the medical instrument is extendable along a path from a position within the first elongate flexible shaft and through the first exit to an extended position outside the first elongate flexible shaft at an angle Θ relative to the longitudinal axis of the first elongate flexible shaft; and 
 wherein the imaging assembly comprises a second elongate flexible shaft having a proximal end portion and a distal end portion, and an imaging device affixed the distal end portion of the second elongate flexible shaft, the imaging device housed within the second working channel and adapted to be translated within the second working channel; 
   extending at least a portion of the medical instrument from within the first working channel out through the first distal exit;   translating the imaging device within the second working channel; and   generating an image in an image plane of at least a portion of the medical instrument extended out the first distal exit using the imaging, wherein the imaging plane of the imaging device is oriented substantially at the angle Θ at which the medical instrument extends out the side exit.   
     
     
         33 . The method of  claim 32  further comprising:
 altering the translation of the imaging device within the second working channel; and 
 generating an additional image of at least a portion of the medical instrument extended out the first exit. 
 
     
     
         34 . The method of  claim 32  further comprising:
 inserting at least a portion of the medical instrument into the target proximate the airway of the patient; 
 altering the translation of the imaging device within the second working channel; and 
 generating an image of at least the portion of the medical instrument and the target as the as the medical instrument is inserted into the target. 
 
     
     
         35 . The method of  claim 34 , further comprising:
 receiving, by a processor coupled to the imaging device, the image generated by the imaging device; and   saving, by the processor, the image to a file.   
     
     
         36 . The method of  claim 32 , wherein the imaging device is a radial endobronchial ultrasound (EBUS) transducer or an optical coherence tomography (OCT) device. 
     
     
         37 . The method of  claim 32 , wherein the medical instrument comprises a needle, an ablation probe, a biopsy device, a forceps device, a brush, an auger, a stylet, an energy delivery device, a therapy delivery device, a cryotherapy device, a laser device, a microwave device, a diffuse infrared laser device, a laser device, a microwave device, or a steam ablation device. 
     
     
         38 . The method of  claim 32 , wherein the medical instrument assembly further comprises:
 a handle assembly having a first end and a second end, the handle assembly comprising a first handle portion proximate the first end and a second handle portion proximate the second end, wherein the second handle portion is slidably engaged with the first handle portion;   a first localization element attached to the first handle portion; and   a second localization element attached to the second handle portion;   wherein the proximal end of the medical instrument is mechanically coupled to the second handle portion and wherein a translation of second handle portion with respect to the first handle portion causes a coincident and coextensive translation of the medical instrument.   
     
     
         39 . The method of  claim 38 , wherein the first and second localization elements are coupled to a processor and the method further comprises sending, to the processor, information associated with a first position in three-dimensional space of the first localization element and information associated with a second position in three-dimensional space of the second localization element. 
     
     
         40 . The method of  claim 39 , further comprising determining the amount of translation of the medical instrument by calculating, by the processor, the distance between the first position of the first localization element and the second position of the second localization element. 
     
     
         41 . The method of  claim 32 , wherein the imaging assembly further comprises:
 a handle assembly having a first end and a second end, the handle assembly comprising a first handle portion proximate the first end and a second handle portion proximate the second end, wherein the second handle portion is slidably engaged with the first handle portion;   a first localization element attached to the first handle portion; and   a second localization element attached to the second handle portion;   wherein the imaging assembly is mechanically coupled to the second handle portion and wherein a translation of second handle portion with respect to the first handle portion causes a coincident and coextensive translation of the imaging device.   
     
     
         42 . The method of  claim 41 , wherein the first and second localization elements are coupled to a processor and the method further comprises:
 sending, to the processor, information associated with a first position in three-dimensional space of the first localization element and information associated with a second position in three-dimensional space of the second localization element;   receiving, by the processor, a population of images generated by the imaging device; and   determining, by the processor, the distance between the population of images by calculating the distance between the first position of the first localization element and the second position of the second localization element for each of the population of images.   
     
     
         43 . The method of  claim 32 , further comprising:
 receiving, by a processor, a population of images generated by the imaging device; and   displaying on a display coupled to the processor, one or more of the population of images received by the processor from the imaging device.