Image guided catheters and methods of use

Abstract

An interventional medical device is provided that incorporates a forward-directed ultrasound or optical coherence tomography imaging system that is replaceable depending on how close the device is to the target site for a given medical procedure, the device and system integrated into a single minimally invasive device comprising a first probe housing, needle guide assembly and sheath, a sleeve lock for closing a normally open needle channel of a needle guide of the first distal assembly and a second probe and cable housing assembly locked to the first distal probe housing, needle guide assembly and sheath by a locking tab. The probe and cable housing assembly may comprise a linear phased ultrasound array and an accelerometer for orienting an image produced by the device with the gravitational field of the earth. The medical device can be in the form of an image guided catheter or probe, used in a body orifice, externally on skin tissue or subcutaneously. The device comprises a replaceable and reusable ultrasound imaging assembly (and or OCT assembly) and replaceable interventional devices such as a removable introducer needle, hollow biopsy needle, syringe or other medical instrument. The imaging system may comprise one or more small ultrasound or OCT imaging systems that can be replaceably integrated into the device by replacing the reusable second probe and cable housing assembly.

What is claimed is: 
     
         1 . An image guided catheter device configured to comprise a distal, disposable section comprising a needle guide and a reusable and replaceable cable and imaging probe housing section that may be inserted into the distal, disposable section via a sheath of the distal, disposable section having a larger diameter than the probe and the distal, disposable and reusable and replaceable sections locked together via a locking tab, the device for use in minimally invasive medical procedures or non-invasive procedures, the imaging probe section adapted for use in a body orifice, at skin surface or subcutaneously, the device comprising:
 a distal housing at a patient end configured to facilitate entry of the image guided catheter device though skin tissue of a human body and comprising a normally open needle guide,   the normally open needle guide adapted to be closed via one of a tab for circular movement of a normally open needle guide to a closed position for surrounding a tool and a sleeve lock comprising a groove and for slidably engaging and compressing the normally open needle guide to the closed position,   the tool comprising one of a solid and a hollow needle having a distal end for exiting via a distal tip of the needle guide when closed and moved into view of a forward-directed ultrasound linear phased array from inside the needle guide to an imaging zone,   the imaging zone adapted to include a patient entry puncture point and up to five centimeters inside a patient body of the needle wherein the housing has a proximal end and a distal end, the proximal end having an outer diameter larger that an outer diameter of the distal end,   the locking tab for locking an assembly comprising a probe containing a linear phased array, leads to each piezoelectric element of the linear phase array, the leads forming a cable for exiting the proximal end of the assembled and locked device,   the normally open needle guide having first and second halves that when normally open are in a position to receive a tool and the tool be enclosed and moveable in the closed needle guide, closed by the one of the tab and the sleeve lock.   
     
     
         2 . The device according to  claim 1 , wherein said cable and probe housing section comprises an imaging channel at the distal end and said transducer assembly comprises a linear phased array arranged in said imaging channel at the distal end and disposed proximate to a flat or domed window at the distal end of the distal, disposable section comprising a needle guide housing. 
     
     
         3 . The device according to  claim 2 , wherein said needle guide and probe housing section has a tapered distal face of the normally open needle guide proximate the distal imaging end of the imaging probe housing and said transducer assembly being disposed behind the window of the face of the distal imaging end when the transducer assembly is disposed and moved into a locked position via the locking tab for locking a distal outer needle guide and probe housing section to a probe and cable section. 
     
     
         4 . The device according to  claim 2 , wherein said probe and cable housing has a linear phased array at a distal end of the probe and a sheath of the probe and cable housing comprises one of an accelerometer and at least one gyroscope for providing an indication to a display device of the degree of spatial rotation and position of the device with respect to the gravitational filed, the display device providing a spatial orientation of an ultrasound image compatible with a spatial orientation of a body during a medical procedure. 
     
     
         5 . The device according to  claim 1 , wherein said disposable distal probe and sheath housing has a flat window face at the distal end thereof. 
     
     
         6 . The device according to  claim 1 , wherein a first ultrasound transducer assembly comprises a linear phased array having linear elements spaced at a pitch of approximately 0.5 to 1.15λ or wavelength and is configured to operate at a center frequency including an approximate fifteen megahertz center frequency range. 
     
     
         7 . The device according to  claim 6 , wherein said ultrasound transducer assembly is replaceable as a part of the probe and cable assembly section and operates at a center frequency selected from an ultrasound frequency range of ten to forty megahertz and is configured to provide one of higher resolution imaging and imaging at a greater spatial depth in the human body during use of the device than a lower frequency range and comprise a linear phased array adaptable for subcutaneous use or in a human body orifice. 
     
     
         8 . The device according to  claim 6 , wherein said linear phased array is configured to provide forward-directed imaging within the body during use of the device and for visualizing a location of a medical procedure and a tool for use at the location of the medical procedure. 
     
     
         9 . The device according to  claim 1 , wherein said housing includes a normally open needle channel extending in a longitudinal direction along the length of an elongate body of the needle channel and probe housing section for receiving a syringe having a hollow needle tip extending from the distal tip of the needle guide the hollow needle for use in extracting unwanted body fluids. 
     
     
         10 . The device according to  claim 9 , the syringe and hollow tip for one of extracting unwanted fluid and delivering medication at a site of a medical procedure. 
     
     
         11 . The device according to  claim 1 , further comprising a syringe for placement in the normally open needle channel, the syringe being configured to be clasped by first and second halves of the needle guide and removably fixed to the distal needle guide and probe housing when in use. 
     
     
         12 . The device according to  claim 11 , the syringe needle being guided via the forward-directed ultrasound linear phased array to a medical procedure site. 
     
     
         13 . The device according to  claim 12 , the device comprising a sleeve lock surrounding a sheath of the needle guide and probe assembly with the locking tab, the sleeve lock comprising a groove for closing the normally open needle guide channel around a tool, the tool moveable within the needle guide channel when closed by the locking sleeve groove, the locking sleeve held in a closed position by a retaining tab, the sleeve lock having gripping grooves adapted to be grasped by a surgeon's fingers. 
     
     
         14 . The device of  claim 1  being configured for intracardiac treatment via pericardial access, a needle adapted to be introduced into a patient body via the normally open but closed needle guide being adapted to puncture a pericardium during use to access a pericardial space and adapted to permit removal of excess pericardial fluid in the pericardial space during a cardiocentesis. 
     
     
         15 . An image guided catheter/probe device configured to be used in minimally invasive or non-invasive medical procedures, comprising:
 a distal probe housing comprising a normally open needle guide and a sheath having proximal and distal ends, the proximal end of the housing having a locking tab for locking a vision probe, cabling, and an assembly comprising at least one of a gyroscope and an accelerometer for providing gravitational orientation of a displayed image, the assembly contained within a proximal reusable housing further comprising a proximal cable from a distal transducer linear phased array of the reusable housing;   a sleeve lock for surrounding the sheath of the distal probe housing for use in closing the normally open needle channel and the normally needle channel retained in a normally open position by a proximal retaining tab and in a closed position via a groove of the sleeve lock for closing first and second halves of the needle channel.   
     
     
         16 . The device according to  claim 15 , a normally open longitudinal needle channel for a removable tool configured to permit introduction of a medical instrument for use at site of a medical procedure under vision of a linear phased transducer array such that the distal probe housing and needle guide are used in one of a body orifice or externally to skin tissue, only the needle channel permitting subcutaneous use of one of a needle, syringe or tool subcutaneously. 
     
     
         17 . An image guided catheter/probe device configured to be used in minimally invasive or non-invasive medical procedures, comprising:
 a disposable distal housing having a normally open needle guide at its distal end configured to facilitate entry of a tool through skin tissue of a human body, the disposable distal housing having proximal and distal ends, said disposable distal housing comprising the normally open needle guide and a removable, reusable probe housing at a distal end and a sheath having a larger diameter than the normally open needle guide and the removable, reusable probe housing for carrying linear phased array signal leads and at least one of an accelerometer and a gyroscope within a the removable, reusable housing comprising a reusable linear transducer phased array probe and cable housing insertable into the disposable distal housing and locked to the disposable distal housing via a locking tab at a side opposite the normally open needle guide, the needle channel disposed longitudinally along the distal tip of the disposable distal housing and proximate the probe housing having a domed or flat window behind which is located the linear phase transducer array probe.   
     
     
         18 . The device of  claim 17 , further wherein one of a solid needle, a hollow needle for biopsy purposes or a syringe, the syringe adapted for introducing a medicine or removing unwanted fluid from a site within a human body, is removable and replaceable within the normally open needle channel of the normally open needle guide,
 the one needle guide under ultrasound vision comprises a needle delivery port in an image plane orthogonal to the linear phased transducer array, the ultrasound vision providing a sequence of images in real time during the medical procedure, the sequence of images aligned with gravity via one of an accelerometer and a gyroscope contained within a probe and cable housing sheath which is reusable and replaceable,   a tool emerging from the needle guide delivery port being visible in an ultrasound image requiring no adjustment of one of the probe and sheath.   
     
     
         19 . The device of  claim 17 , wherein said probe and needle guide housing further includes at least one normally open imaging channel extending along the distal end of the probe and needle guide housing, the probe and needle guide housing having a window behind which is located a linear phased array comprising twenty-three piezoelectric elements having an approximately 0.1 millimeter pitch forming a linear phased array comprising a size of approximately 2.3 millimeters by 2.3 millimeters at a center frequency of fifteen megahertz. 
     
     
         20 . The device of  claim 17  further comprising one of an accelerometer and a gyroscope, the one of the accelerometer and the gyroscope for sensing a present orientation and position of the device with reference to a spatial orientation and position of a body undergoing a medical procedure and outputting orientation and position data of the device via the probe and cable assembly to processing for display and for presenting an ultrasound transducer image compatible with the spatial orientation and position of the body undergoing the medical procedure in alignment with a gravitational field of the earth.