Patent Publication Number: US-2023157522-A1

Title: Direct Vision Cryosurgical Probe and Methods of Use

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is a Continuation of U.S. application Ser. No. 17/030,047, filed Sep. 23, 2020, which is a Continuation of U.S. application Ser. No. 15/804,652, filed Nov. 6, 2017, which is a Continuation of U.S. application Ser. No. 14/339,024 filed Jul. 23, 2014, which claims priority to U.S. Provisional Application No. 61/858,104 filed Jul. 24, 2013, the full disclosures of all of which are incorporated herein by reference in their entirety for all purposes. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to cryosurgical probes and their methods of use. More particularly, the present invention relates to cryosurgical probes which are configured to be advanced into a body lumen while providing for direct visualization. 
     BACKGROUND OF THE INVENTION 
     Accessing and treating regions within a body lumen such as the nasal cavities are often performed by utilizing a probe which is cooled via a chilled fluid, a cryo-fluid such as Nitrous Oxide, or through some other cooling mechanism. The cooled tip can be placed into contact against the tissue region to be treated. However, proper positioning of the cooling probe relative to the tissue may be difficult to achieve due to a number of factors such as limited space, lack of visual contact, anatomical obstructions, etc. 
     Accordingly, devices and methods which can overcome such obstacles to effectively treat tissue regions in body lumens through cryo-therapy are needed. 
     SUMMARY OF THE INVENTION 
     It is an object of this invention to provide a surgical system for image guided cryo-ablation of a discrete anatomical structure within a mammalian body, through a surgically created or natural body orifice, for the purpose of diagnosing or treating disease or injury. 
     In accordance with one aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end with a cryo-ablation probe through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes. 
     In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end with a cryo-surgical probe through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the needle tip is configured for advancement towards a surgical target through a facial boundary between two or more discrete anatomical structures in a substantially atraumatic manner, and the imaging device is used to guide the advancement of the needle tip. 
     In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging, and further comprising an inflatable structure proximal to the needle tip; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end with a cryosurgical probe through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, and a means for inflating the inflatable structure, whereby the needle tip is configured for advancement towards a surgical target through a facial boundary between two or more discrete anatomical structures in a substantially atraumatic manner, and the imaging device is used to guide the advancement of the needle tip, and the inflatable structure is configured to further separate the anatomical structure(s) as the needle tip is advanced. 
     In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the objective lens, a CMOS imaging sensor, and at least one light emitting diode configured for tissue illumination. 
     In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end with a cryo-surgical probe through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the imaging device is an endoscope comprising an objective lens, a coherent fiber optic bundle configured for imaging, and a second optical bundle configured for illumination. 
     In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end with a cryo-surgical probe through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the imaging device is an endoscope comprising an objective lens, and at least one relay lens configured for tissue imaging, and a fiber optic bundle configured for tissue illumination. 
     In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end with a cryo-surgical probe through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the minor dimension of the lateral fenestration approximates the working diameter of the central lumen. 
     In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end with a cryo-surgical probe through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the lateral fenestration is substantially perpendicular to the axis of the central lumen. 
     In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging, and at least one cryosurgical probe configured for distal tissue freezing; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the fluid is a clear ionic liquid. 
     In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging, and at least one cryosurgical probe configured for distal tissue freezing; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for delivering or removing fluid to/from the vicinity of the distal end through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the fluid is pressurized to facilitated dissection and distal advancement. 
     In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging, and at least one cryosurgical probe configured for distal tissue freezing; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for delivering or removing fluid from the vicinity of the distal end through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the fluid is an evaporated liquid refrigerant that is introduced to the distal region by the cryosurgical probe during distal tissue freezing. 
     In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging, and at least one cryosurgical probe configured for distal tissue freezing; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for delivering or removing fluid to/from the vicinity of the distal end through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the fluid is comprises an anesthetic. 
     In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the handle, central lumen, and lateral fenestration are configured to receive a surgical probe for surgical access to distal tissue, wherein the surgical probe may be a cryosurgical probe configured for distal tissue freezing. 
     In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the handle, central lumen, and lateral fenestration are configured to receive a surgical probe for surgical access to distal tissue, wherein the surgical probe may be a cryosurgical probe configured for distal tissue freezing by means of direct application of liquid refrigerant to the target distal tissue. 
     In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the handle, central lumen, and lateral fenestration are configured to receive a surgical probe for surgical access to distal tissue, wherein the surgical probe may be a cryosurgical probe configured for distal tissue freezing comprising a distal refrigerant evaporation chamber in direct contact with the target distal tissue, with the evaporation chamber comprising a hollow metallic structure. 
     In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the handle, central lumen, and lateral fenestration are configured to receive a surgical probe for surgical access to distal tissue, wherein the surgical probe may be a cryosurgical probe configured for distal tissue freezing comprising a distal refrigerant evaporation chamber in direct contact with the target distal tissue, with the evaporation chamber comprising an inflatable balloon. 
     In accordance with another aspect of this invention is a method for accessing a distal region in a mammalian body through a natural dissection plane in order to perform at least one diagnostic or therapeutic cryosurgical step comprising inserting into the body a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, and housing at least one imaging device configured for distal imaging, and housing at least one removable cryosurgical probe configured for distal tissue freezing; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end through the central lumen and the lateral fenestration(s); then advancing the surgical device in the direction of the distal region while maneuvering the distal tip between the facial boundaries of intervening anatomical structures using images from the imaging device(s) and imaging display(s) to guide the maneuvering. 
     In accordance with another aspect of this invention is a method for accessing a distal region in a mammalian body through a natural dissection plane in order to perform at least one diagnostic fenestration in communication with the central lumen, and housing at least one imaging device configured for distal imaging, and further comprising an inflatable structure proximal to the needle tip; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, and a means for inflating the inflatable structure; then advancing the surgical device in the direction of the distal region while maneuvering the distal tip between the facial boundaries of intervening anatomical structures using images from the imaging device(s) and imaging display(s) to guide the maneuvering, and inflating the inflatable structure as needed to facilitate distal advancement. 
     In accordance with an alternative embodiment of this invention is a cryosurgical probe comprising an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an inflatable balloon structure configured as a refrigerant evaporation chamber, and as an optical imaging window, enclosing at least one optical imaging device; with said proximal end comprising a means for introducing a liquid refrigerant into the distal balloon through a central lumen, a means of removing evaporated refrigerant from the cryosurgical probe at a predetermined pressure, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the balloon with a liquid or a gas. 
     An alternative embodiment of this invention is a cryosurgical probe comprising an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an inflatable balloon structure configured as a refrigerant evaporation chamber, and as an optical imaging window, enclosing at least one optical imaging device; with said proximal end comprising a means for introducing a liquid refrigerant into the distal balloon through a central lumen, a means of removing evaporated refrigerant from the cryosurgical probe at a predetermined pressure, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the balloon with a liquid or a gas. 
     In accordance with one aspect of the alternative embodiment of this invention is a cryosurgical probe comprising an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an inflatable balloon structure configured as a refrigerant evaporation chamber, and as an optical imaging window, enclosing at least one optical imaging device; with said proximal end comprising a means for introducing a liquid refrigerant into the distal balloon through a central lumen, a means of removing evaporated refrigerant from the cryosurgical probe at a predetermined pressure, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the balloon with a liquid or a gas, whereby, the imaging device is configured for lateral imaging. 
     In accordance with another aspect of the alternative embodiment of this invention is a cryosurgical probe comprising an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an inflatable balloon structure configured as a refrigerant evaporation chamber, and as an optical imaging window, enclosing at least one optical imaging device; with said proximal end comprising a means for introducing a liquid refrigerant into the distal balloon through a central lumen, a means of removing evaporated refrigerant from the cryosurgical probe at a predetermined pressure, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the balloon with a liquid or a gas, whereby, the imaging device comprises at least one coherent optical fiber bundle, configured for transmitting an image from within the inflatable balloon to a camera in the vicinity of the proximal end. 
     In accordance with another aspect of the alternative embodiment of this invention is a cryosurgical probe comprising an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an inflatable balloon structure configured as a refrigerant evaporation chamber, an optical imaging window, and as a tissue dilator enclosing at least one optical imaging device; with said proximal end comprising a means for introducing a liquid refrigerant into the distal balloon through a central lumen, a means of removing evaporated refrigerant from the cryosurgical probe at a predetermined pressure, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the balloon with a liquid or a gas, whereby, the imaging device comprises a probe with a distal end and a proximal end configured for removable insertion into the inflatable balloon through a central lumen, with the distal end comprising an imaging means, and the proximal end comprising a means for connecting the probe to an image display. 
     In accordance with another aspect of the alternative embodiment of this invention is a cryosurgical probe comprising a substantially rigid elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an inflatable balloon structure configured as a refrigerant evaporation chamber, an optical imaging window, and as a tissue dilator enclosing at least one optical imaging device; with said proximal end comprising a means for introducing a liquid refrigerant into the distal balloon through a central lumen, a means of removing evaporated refrigerant from the cryosurgical probe at a predetermined pressure, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the balloon with a liquid or a gas, whereby the cryosurgical probe is configured for insertion into the targeted surgical site. 
     In accordance with another aspect of the alternative embodiment of this invention is a cryosurgical probe comprising a substantially flexible elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an inflatable balloon structure configured as a refrigerant evaporation chamber, an optical imaging window, and as a tissue dilator enclosing at least one optical imaging device; with said proximal end comprising a means for introducing a liquid refrigerant into the distal balloon through a central lumen, a means of removing evaporated refrigerant from the cryosurgical probe at a predetermined pressure, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the balloon with a liquid or a gas, whereby the cryosurgical probe is configured for insertion into the targeted surgical site by means of a tortuous insertion pathway. 
     In accordance with another aspect of the alternative embodiment of this invention is a cryosurgical probe comprising an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an inflatable balloon structure configured as a refrigerant evaporation chamber, an optical imaging window, and as a tissue dilator enclosing at least one optical imaging device; with said proximal end comprising a means for introducing a liquid refrigerant into the distal balloon through a central lumen, a means of removing evaporated refrigerant from the cryosurgical probe at a predetermined pressure, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the balloon with a liquid or a gas, whereby the predetermined pressure is maintained by a pressure relief valve in line between the interior of the balloon and the ambient atmosphere, wherein the cryosurgical probe is configured for lateral tissue freezing by means of spraying a liquid refrigerant at an interior radial segment of the balloon from a central lumen. cryosurgical probe comprising an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an outer inflatable balloon structure configured as an optical imaging window, and as a tissue dilator enclosing at least one optical imaging device, at least one inner cryogenic evaporator balloon, and at least one inner thermal insulation balloon; with said proximal end comprising a means for introducing a liquid refrigerant into the cryogenic evaporator balloon through a central lumen, a means of removing evaporated refrigerant from the cryogenic evaporator balloon through a central lumen at a predetermined pressure, a means for inflating the thermal insulation balloon with the pressurized evaporated refrigerant gas, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the outer balloon with a liquid or a gas. 
     In accordance with another aspect of the alternative embodiment of this invention is a cryosurgical probe comprising an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an outer inflatable balloon structure configured as an optical imaging window, and as a tissue dilator enclosing at least one optical imaging device, at least one inner cryogenic evaporator balloon, and at least one inner thermal insulation balloon; with said proximal end comprising a means for introducing a liquid refrigerant into the cryogenic evaporator balloon through a central lumen, a means of removing evaporated refrigerant from the cryogenic evaporator balloon through a central lumen at a predetermined pressure, a means for inflating the thermal insulation balloon with the pressurized evaporated refrigerant gas, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the outer balloon with a liquid or a gas, whereby the outer balloon is fabricated from a substantially non-elastic material, and the inner balloons are fabricated from a substantially elastic material. 
     In accordance with another aspect of the alternative embodiment of this invention is a cryosurgical probe comprising an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an outer inflatable balloon structure configured as an optical imaging window, and as a tissue dilator enclosing at least one removably insertable optical imaging device, at least one inner cryogenic evaporator balloon, and at least one inner thermal insulation balloon; with said proximal end comprising a means for introducing a liquid refrigerant into the cryogenic evaporator balloon through a central lumen, a means of removing evaporated refrigerant from the cryogenic evaporator balloon through a central lumen at a predetermined pressure, a means for inflating the thermal insulation balloon with the pressurized evaporated refrigerant gas, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the outer balloon with a liquid or a gas, whereby the inner balloons are configured to conform to the inner surface of the outer balloon when pressurized with refrigerant. 
     It is further an object of this invention to provide a method for performing a cryosurgical procedure comprising inserting a cryosurgical probe into the body of a patient, and then advancing the distal end of the probe into the vicinity of the surgical target, with the cryosurgical probe comprising: an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an inflatable balloon structure configured as a refrigerant evaporation chamber, and as an optical imaging window enclosing at least one optical imaging device; with said proximal end comprising a means for introducing a liquid refrigerant into the distal balloon through a central lumen, a means of removing evaporated refrigerant from the cryosurgical probe at a predetermined pressure, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the balloon with a liquid or a gas; then inflating the balloon and imaging the anatomy surrounding the balloon, then determining whether the cryosurgical probe is in a correct position for cryosurgical ablation based at least in part on the imaging, then, if the determination is that the cryosurgical probe is in a correct position then proceeding with the cryosurgical ablation, and alternatively, if the determination is that the cryosurgical probe is not in the correct position, then repositioning the cryosurgical probe until the cryosurgical probe is in a correct position, as determined at least in part by the imaging, whereby determining correct position may comprise determining the position of a lateral tissue freezing zone of the cryosurgical probe in relation to the adjacent anatomy. 
     An additional object of this invention is a method for cryosurgical ablation of the function of a nerve comprising inserting a cryosurgical probe between the target nerve and the artery and vein associated with the nerve; with the cryosurgical probe having an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an outer inflatable balloon structure configured as an optical imaging window, and as a tissue dilator enclosing at least one optical imaging device, at least one inner cryogenic evaporator balloon, and at least one inner thermal insulation balloon; with said proximal end comprising a means for introducing a liquid refrigerant into the cryogenic evaporator balloon through a central lumen, a means of removing evaporated refrigerant from the cryogenic evaporator balloon through a central lumen at a predetermined pressure, a means for inflating the thermal insulation balloon with the pressurized evaporated refrigerant gas, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the outer balloon with a liquid or a gas; then inflating the outer balloon to create distance between the nerve and the vein and artery; then using the imaging device, position the inner cryo balloon proximate to the nerve, and the inner insulation balloon proximate to the vein and artery; then introducing liquid refrigerant into the cryo balloon causing inflation of the inner cryo balloon and the inner insulation balloon; then maintaining the flow of refrigerant for a period of time sufficient for affecting the nerve function in the desired manner, whereby, the vein and artery remain unaffected by cold due to the separation between the target nerve end the vein and artery, and the thermal insulating effect of the inner thermal insulation balloon. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    shows a perspective view of a surgical imaging probe configured for accessing a distal surgical site within a patient using image guidance. 
         FIG.  2    shows a perspective view of the distal end of the surgical probe having an optically transparent needle tip mounted on the probe shaft. 
         FIG.  3    shows a cross sectional illustration of the distal end of the surgical probe depicting the probe shaft, optically transparent needle tip, and imaging element. 
         FIG.  4    shows a cross sectional illustration of the distal end of the surgical probe which is configured for direct application of a liquid refrigerant on target tissue within the field of view of the imaging element. 
         FIGS.  5 A and  5 B  show cross sectional side views of the distal end of the surgical probe illustrating a cryosurgical balloon probe having a balloon member which is inflatable upon introduction of a liquid refrigerant. 
         FIG.  6 A  shows a schematic illustration of a surgical probe inserted into the body of a patient and advanced through tissue towards the target distal region while under visual guidance. 
         FIG.  6 B  shows an illustration of an image received from the imaging element positioned within the probe. 
         FIG.  6 C  shows an illustration of an image from imaging element showing the target distal region residing between facial surfaces which have been separated by the manipulation of the surgical probe. 
         FIG.  7 A  shows a side view of a variation of the distal end of an Image Guided Directed Cryosurgical Balloon (IGCB) probe. 
         FIG.  7 B  shows a cross sectional end view of the IGCB probe. 
         FIG.  7 C  shows a schematic illustration of a variation of the proximal terminal of the IGCB probe. 
         FIG.  8    shows a cross sectional schematic side view of a variation of the distal end of a lateral optical imaging probe. 
         FIG.  9 A  shows the distal end of the IGCB probe with an inflated outer balloon and a lateral optical imaging probe imaging the surrounding anatomy from within the outer balloon as represented by field of view. 
         FIG.  9 B  shows the distal end of IGCB probe  101  with the outer balloon removed for clarity to reveal an inner cryo balloon in a deflated configuration and an inner thermal insulation balloon in a deflated configuration. 
         FIG.  9 C  shows a cross sectional side view of the distal end of the IGCB probe. 
         FIG.  10    shows a cross sectional end view of the IGCB probe taken proximal to the inflatable outer balloon. 
         FIG.  11    shows a cross section side view of the distal end of the IGCB probe during a cryosurgical procedure. 
         FIG.  12    shows a transverse cross sectional end view of the IGCB probe illustrating cryogenic fluid being sprayed at an inner wall of the inner balloon. 
         FIG.  13    shows a schematic illustration of the proximal terminal of the IGCB probe. 
         FIG.  14    shows a cross sectional end view of a nerve undergoing cryo-ablation using the IGCB probe. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIG.  1    is an illustration of the central embodiment of surgical imaging probe  1  configured for accessing a distal surgical site within a patient by advancement between anatomical structures by atraumatic blunt dissection using image guidance for the purpose of performing a cryosurgical step. Surgical imaging probe  1  comprises probe shaft  2 , non-coring optically transparent needle tip  3 , probe handle  8 , electrical lead  4 , electrical connector  5  fluid tube  6  and fluid connector  7 . Probe shaft  2  is between approximately 5 and 20 centimeters long, and between approximately 2.5 and 3.5 millimeters in diameter. Probe shaft  2  has a central lumen between approximately 2.3 and 3.3 millimeters in diameter. Probe shaft  2  may be fabricated from a stainless steel hypodermic tube, or may be fabricated from another metal used in surgical instruments such as titanium. Probe shaft  2  is substantially rigid and is capable of transmitting lateral, longitudinal, and torsional forces along its length. Distal needle tip  3  is configured for blunt atraumatic dissection between the fascias of discrete anatomical structures. Distal needle tip  3  is optically transparent and houses an optical imaging device that is connectable to an imaging display. The optical images are used by the surgeon identify a facial plane through which the surgical probe may safely be advanced towards a target distal region within the body. Distal needle tip  3  also comprises a lateral fenestration which communicates with the interior of distal needle tip  3 , and the central lumen of probe shaft  2 . Distal needle tip  3 , probe shaft  2  are described in greater detail below. Surgical probe handle  8  is configured in an ergonomic manner to provide the surgeon with a comfortable grip of surgical probe  1 , and good tactile feedback of the forces resulting from manipulation of surgical probel during the surgery. Surgical probe handle  8  also comprises a means for fluid communication between fluid tube  6  and the central lumen in probe shaft  2 . Fluid connector  7  is a female luer fitting as depicted and is configured for connection to a syringe or another fluid source. Additionally, a cryosurgical surgical probe may be inserted through surgical probe  1  for distal use using fluid connector  7 , fluid tube  6 , the central lumen of probe shaft  2  and exiting through the lateral fenestration of needle tip  3 . Electrical lead  4 , and electrical connector  5  are configured to connect the optical imaging device mounted within needle tip  3  to an optical imaging display. Electrical lead  4 , and electrical connector  5  may provide a means for connecting additional sensors mounted within surgical probe  1  that may include sensors configured to detect temperature, cardiac signals, bodily fluid chemistry, dissecting force, fluid pressure, ionizing radiation, non-visible light, or a magnetic field. Electrical lead  4  and electrical connector may be configured for connecting a therapeutic energy emitting device mounted within surgical probe  1  to a source of therapeutic energy. 
       FIG.  2    is an illustration of the distal end of surgical probe  1  showing the distal end of probe shaft  2 , with optically transparent needle tip  3  mounted on probe shaft  2 . Needle tip  3  comprises a non-coring needle tip design where the distal face of the needle tip is smooth with a large radius  10  as shown, and comprises a lateral fenestration  9  that communicates between the distal exterior of surgical probe  1  and the interior of needle tip  3  and the central lumen of probe shaft  2 . Radiused edge  11  is configured to smooth the edge formed between large radiused surface  10  and fenestration  9  to prevent puncture or incision of tissue as surgical  1  is advanced in the distal direction between anatomical structures. 
       FIG.  3    is a cross sectional illustration of the distal end of surgical probe  1  depicting probe shaft  2 , optically transparent needle tip  3 , CMOS camera with integral illumination  12 , camera mount  13 , central lumen  16 , electrical cable  14 , and camera field of view  15 . Probe shaft  2  comprises central lumen  16 , and a stepped segment  17  configured for mounting needle tip  3 . Needle tip  3  is fabricated from an optically transparent, mechanically rigid material, which may a glass material, or may be a plastic material such as polycarbonate. Those skilled in the art of glass forming, or plastic molding of optical components are familiar the fabrication techniques that may be used for fabricating needle tip  3  as disclosed here within, therefore no further description is warranted. Needle tip  3  is a hollow tubular structure with a central axis substantially aligned with the central axis of probe shaft  2  at its proximal end, and with the central axis substantially perpendicular to the central axis of probe shaft  2  as shown. The distal face is blunt as defined by large radius  10 . Fenestration  9  communicates between the interior of needle tip  3  and central lumen  16 , and the exterior of surgical probe  1 . Fenestration  9  may be configured as shown, or may alternatively be more than one single fenestration. Fenestration  9  may have a diameter that is similar to the diameter of central lumen  16  and suitable for passing a surgical instrument through, or may be substantially smaller than central lumen  16 . Camera  12  may be a miniature CMOS camera with integral illumination and similar to cameras offered by Awaiba Corp. which are described in detail at www.awaiba.com, and therefore no further description is warranted here. Camera  12  is mounted to the inner surface of needle tip  3  by camera mount  13 , which is configured to point camera  12  so field of view  15  is in the distal direction, and substantially encompasses fenestration  9  as shown. An alternate optical imaging device, not shown may be employed for distal imaging, which may be a fiberscope, of a rigid endoscope mounted within central lumen  16 . Camera mount  13  may be integrally molded into needle tip  3  as shown, or may be separate component that is bonded to the interior of needle tip  3 . Electrical cable  14  connects camera  12  to electrical connector  5  at the proximal end of surgical probe  1 , and resides within central lumen  16  as shown. 
       FIG.  4    is a cross sectional illustration of the distal end of surgical probe  1  depicting cryosurgical probe  18 , which is configured for direct application of liquid refrigerant on target tissue to effect tissue freezing. As shown cryosurgical probe  18  is extending from central lumen  16  and needle tip  3  in position for spraying liquid refrigerant  50  through distal cryo-nozzle  49  on target distal tissue within the field of view  15  of camera  12 . Also as depicted, evaporated refrigerant  51  is vented back to ambient atmosphere through central lumen  16 . Camera  12  may be used to monitor and guide tissue freezing. Cryosurgical probe  18  may comprise a steerable distal segment that may be utilized to direct the spray of liquid refrigerant. Those skilled in the art of steerable catheters are familiar with designs and manufacturing process for incorporating steerable function into cryosurgical probe  18 , therefore no further description is warranted. 
       FIG.  5 A  is a cross sectional illustration of the distal end of surgical probe  1  configured for distal tissue ablation utilizing cryosurgical probe  52  comprising a closed distal evaporator chamber  53 , which freezes target tissue by contact with the surface of evaporator  53 , and by thermal conduction of heat from the target tissue into evaporator chamber  53 . Cryosurgical probes with closed distal evaporation chambers are thoroughly and widely described in the prior art, therefore no further description of cryosurgical probe  52  is warranted.  FIG.  5 B  is a cross sectional illustration of the distal end of surgical probe  1  configured for distal tissue ablation utilizing cryosurgical balloon probe  54  comprising a closed distal evaporator balloon chamber  55 , which inflates upon introduction of liquid refrigerant into the interior of balloon  55  and freezes target tissue by contact with the surface of balloon  55 , and by thermal conduction of heat from the target tissue into evaporator balloon chamber  55 . Cryosurgical probes with closed distal evaporation balloon chambers are thoroughly and widely described in the prior art, therefore no further description of cryosurgical probe  54  is warranted. 
       FIG.  6 A  is a schematic illustration of surgical probe  1  being inserted into the body of a patient  30  and being advanced in a distal direction through tissue  31  towards target distal region  32  under visual guidance. Surgical probe  1  may be manipulated in torsional and lateral directions as represented by the crossed arrows in order to find a facial boundary between two or more discrete anatomical structures through which surgical probe  1  may be safely advanced in the distal direction towards the target distal region  32 .  FIG.  6 B  is an illustration showing an image from camera  12 . Visible in the image is distal tissue comprising discrete anatomical structures  36 , and  35 , which is separated by facial boundary  34 . Fenestration  9  is shown in full view.  FIG.  6 C  is an illustration showing an image from camera  12  showing the target distal region  32  residing between facial surfaces  37  and  38 , which have been separated by the manipulation of surgical probe  1  facilitating one or more surgical therapeutic or diagnostic step(s), including a possible cryosurgical step, as depicted by frozen tissue  56 . 
       FIGS.  7 A,  7 B and  7 C  are schematic illustrations of Image Guided Directed Cryosurgical Balloon (IGCB) probe  60 . IGCB Probe  60  comprises probe shaft  61 , balloon  62 , distal tip  63 , optical imaging probe  64 , cryogen tube  65 , and proximal terminal  66 . 
       FIG.  7 A  depicts the distal end of IGCB probe  60  showing balloon  62  bonded to probe shaft  61  at its proximal end, and bonded to distal tip  63  at its distal end. Also shown is cryogen tube  65  mounted between probe shaft  61  and distal tip  63 . Cryogen tube  63  comprises a linear array of lateral cryogen nozzles  67 . Lateral cryogen nozzle array  67  are small fenestrations through on wall of cryogen tube  65 , and are between approximately 50 and 150 microns in diameter, and number between one and approximately 20 or more. Lateral cryogen nozzles  67  may formed by a laser machining operation. Cryogen tube  65  is connectable to a source of cryogenic liquid at proximal terminal  66 , and is configured to spray a lateral region of balloon  62  with liquid cryogen to form lateral tissue freezing zone  68 . Cryo tube  65  and balloon  62  are configured so that substantially all of the liquid cryogen sprayed at the inner wall of balloon  62  is evaporated on contact, and balloon  62  is substantially filled with cryogen in a gaseous state, which is thermally insulative, thereby limiting tissue freezing to tissue adjacent to tissue freezing zone  68 . Cryo tube  65  is also configured to mechanically link probe shaft  61  to distal tip  63  and to translate axial and lateral forces between probe shaft  61  and distal tip  63  to a degree sufficient to maneuver IGCB probe  60  into position within a mammalian body for the purpose of performing at least one cryosurgical step. The inner lumen of cryogen tube  65  is terminated and sealed at distal tip  63 , thereby, all cryogen leaves cryogen tube  65  through lateral cryogen nozzle array  67 . Cryogen tube  65  may be fabricated from stainless steel or Nitinol® hypodermic tube. Optical imaging probe  64  may be removably inserted into the interior of balloon  62  though central lumen  69 , and imaging port  70  of proximal terminal  66  (See  FIG.  7 C ). Optical imaging probe  64  is configured for lateral imaging as depicted by imaging field of view  71 . Optical imaging probe  64  and IGCB probe  60  are configured with an imaging range of motion that is substantially 360 degrees of lateral imaging, and with an axial range that approximates the length of the balloon  62 . Imaging probe  64  is described in greater detail below. Balloon  62  is configured for tissue dilation, and as an optical window for optical imaging probe  64 . Balloon  62  may be fabricated from a substantially in-elastic material with good optical clarity such PET. Balloon  62  is configured to have a burst strength of between approximately 4 and 12 atmospheres of pressure, at a cryogenic temperature between zero, and minus 100 degrees centigrade. Balloon  62  is bonded using an adhesive to the distal end of probe shaft  61 , and the proximal end of distal tip  63  as shown. Balloon  62  may be inflated (as shown) with a liquid or a gas though at least one central lumen in probe shaft  61 , and a fluid port on proximal terminal  66 , which is described in detail below. Balloon  62  may also be inflated during cryogen spraying using the expansion of the evaporating cryogen and a pressure regulating valve mounted within distal terminal  66  disposed between the interior of balloon  62  and the ambient atmosphere, which is described in more detail below. Those skilled in the art of surgical balloon probe design and manufacture are familiar with means for designing and manufacturing IGCB probe as disclosed here within, therefore, no further explanation is warranted. Probe shaft  61  may be substantially rigid, and fabricated as a metal extrusion, or may be substantially flexible and fabricated from a plastic material such as urethane, PeBax®, nylon, or polyethylene. Distal tip  63  may be bullet shaped as shown, and may have a guidewire channel  77  as shown for assisting in positioning IGCB probe  60  into position for performing a cryosurgical step. Distal tip  63  may be a molded or extruded plastic material, or may be machined from metal. 
       FIG.  7 B  is a sectional illustration taken at section A-A in  FIG.  7 A . Depicted in  FIG.  7 B  is cryogen  75  being sprayed against a lateral section of balloon  62  (lateral tissue freezing zone  68 ) through lateral cryogen nozzle array  67  in cryogen tube  65 . Also shown is ice ball  72  formed in tissue adjacent to lateral tissue freezing zone  68 . Optical imaging probe  64  is shown imaging tissue diametrically opposed to lateral tissue freezing zone  68 . Also depicted are balloon lumens  73  and  74  which are in fluidic communication with proximal terminal  66 . Balloon lumens  73  and  74  may be used to together or separately for inflating the balloon with a liquid or gas prior to or after tissue freezing, and are used to vent evaporated cryogen from balloon  62 . 
       FIG.  7 C  is a schematic illustration of proximal terminal  66  of IGCB probe  60 . Hub  78  fluidically connects balloon lumens  73  and  74  to balloon lumen hub tube  79 , cryogen tube  65  to cryogen hub tube  85 , and provides an insertion path for optical probe  64  into optical probe lumen  69  though optical probe port  86  and optical probe hub tube  87 . Hub  78  is insert molded using mandrels to create discrete channels between the hub tubes and lumens described above. Those skilled in the art of surgical probe hub design and manufacture are familiar methods for designing and manufacturing the IGCB probe hub as disclosed here within, therefore no further description is warranted. Imaging probe  64  is inserted into imaging probe lumen  69  through imaging probe port  86  and imaging probe hub tube  87 . Imaging probe port  86  may comprise a Toughy Borst connector, or another type of surgical pressure port. Imaging module  88  comprises a camera and a light source. The camera images the proximal end of the coherent optical fiber bundle of imaging probe  64 , and the light source provides illumination to the distal surgical field, with the light being transmitted distally by a second optical fiber or fiber bundle. Optical imaging probe  64  will be described in further detail below. Imaging module  88  is connected to an imaging display, not shown. Cryogen tube  65  is connected to a source of liquid cryogen  90  by means of cryogen port  84 , cryogen source hose  91 , and cryogen connector  92 . Liquid cryogen source  90  is depicted schematically as a cryogen tank. The liquid cryogen source may comprise a control console that controls the flow of cryogen based on user settings, and feedback from sensors, not shown. The liquid cryogen may be liquid carbon dioxide or liquid nitrogen, or a liquid chlorofluorocarbon compound. Alternatively, instead of using evaporative cooling, a Joules-Thompson effect (adiabatic gas expansion) cooling architecture could employed and still be within the scope of this invention. Nitrous oxide or argon gas would be the preferred cryogenic gasses for use if a Joule-Thompson cooling architecture is employed. Those skilled in the art cryosurgical probe design and manufacture are familiar the design attributes and trade-offs between liquid cryogen evaporative cooling and Joule-Thompson effect cooling architectures, and are familiar with the means for employing either cooling architecture within the scope of this invention, therefore no further discussion is warranted. Balloon lumens  73  and  74  are in fluidic communication with balloon lumen hub tube  79 . Stop cock  80  provides the user a means to either inflate balloon  62  prior to or after a cryosurgical step using syringe  81 . Syringe  81  may also be used to deflate balloon  62 . During a cryosurgical step, the stop cock  80  is configured to fluidically connect pressure relief valve  82  to balloon lumen hub tube  79 , and fluidically disconnect syringe  81  from balloon lumen hub tube  79 . Pressure relief valve  82  vents evaporated cryogen  83  to the ambient atmosphere while maintaining a set pressure within balloon  62  during liquid cryogen delivery. The pressure created by pressure relief valve  82  is used to maintain inflation and tissue dilation force for balloon  62  in order to maintain a spatial separation between tissue targeted for freezing, and tissue intended to be protected from freezing. Pressure relief valve  82  may have a fixed preset pressure relief setting, or pressure relief valve  82  may have a user adjustable pressure setting within a range of pressures that are lower than the burst strength of balloon  62 . Pressure relief valve  82  may also comprise an audible indication of the volumetric flow rate of evaporated cryogen  83  exiting pressure relief valve  82 . The audible indication may be in the form of a whistle where the pitch or volume of the whistle may increase as the flow rate of evaporated cryogen  83  increases. The audible signal may provide the user with an indication of tissue freezing effectiveness, or an indication of device failure, such as a cryo balloon  62  failure. 
       FIG.  8    is a cross sectional schematic illustration of the distal end of lateral optical imaging probe  64 . Lateral optical imaging probe  64  comprises imaging probe sheath  93 , fiber bundle  100  comprising central coherent fiber bundle  94  and outer non-coherent fiber bundle  95 , and imaging element  96  comprising objective lens  97 , lateral reflective surface  98 , and imaging window  99 . Imaging probe sheath  93  houses optical fiber bundle  100 , and is used to mount imaging element  96  at the distal end of lateral optical imaging probe  64 . Imaging probe sheath  93  may fabricated from a thin walled polyimide tubing. The outer diameter of optical imaging sheath  92  is between approximately 0.8 mm and 1.5 mm in diameter, with a length suitable to the particular IGCB probe, which may vary based on specific surgical requirements. Imaging element  98  is machined from optical grade glass forming objective lens  97 , lateral reflecting surface  98  and optical imaging window  99 . Objective lens  97  creates an image of the anatomical surroundings within field of view  71  on the surface of coherent optical bundle  94 . A camera within imaging module  88  at the proximal end of lateral optical imaging probe  64  converts the image to video image for surgical guidance. Non-coherent fiber optical bundle  95  transmits light from a light source within proximal imaging module  88  to illuminate field of vision  71 . Lateral reflecting surface  98  may be a mirror coated surface, or may function as a prism. Those skilled in the art of fiber scopes, and optical engineering are familiar with means for designing and developing a lateral optical imaging as disclosed here within, and remain within the scope of this invention, therefore, no further description is warranted. 
       FIGS.  9 A,  9 B, and  9 C  are schematic illustrations of the distal end of Image Guided Cryo Balloon (IGCB) probe  101 , which is an alternative embodiment to IGCB probe  60 . IGCB probe  101  comprises probe shaft  102 , outer balloon  103 , distal tip  104 , inner cryo balloon  105 , inner thermal insulation balloon  106 , cryogen balloon tube  107 , insulation balloon tube  109 , lateral optical imaging probe  64 , with lateral field of view  71 , and cryogen vent tube  108 , and proximal terminal  109 , which will be described in detail below. 
       FIG.  9 A  shows the distal end of IGCB probe  101 , with outer balloon  103  inflated, and lateral optical imaging probe  64  imaging the surrounding anatomy from within outer balloon  103 , as represented by field of view  71 . The proximal end of outer balloon  103  is bonded to the distal end of probe shaft  102 , and the distal end of outer balloon  103  is bonded to the proximal end of distal tip  104 .  FIG.  9 B  shows the distal end of IGCB probe  101  with outer balloon  103  hidden, revealing inner cryo balloon  105  in a deflated configuration, inner thermal insulation balloon  106  in a deflated configuration, with cryo balloon tube  107 , and inner insulation balloon tube  109  mounted between distal tip  104  and probe shaft  102 . Also depicted is lateral optical imaging probe  64  with field of view  71 .  FIG.  9 C  is a cross sectional view of the distal end of IGCB probe  101  taken at section marks B-B in  FIG.  9 A . Cryogen nozzle array  111  is directs and meters liquid cryogen into inner cryogen balloon  105 . Cryo nozzle array  111  is an array of small fenestrations in the wall of cryogen balloon tube  107 , and are between 50 and 150 microns in diameter, and number between one and approximately 20, all located within the interior of inner cryo balloon  105 . Vent ports  112  are fenestrations in the wall of inner insulation balloon tube  109  and provide fluidic communication between the inner lumen of inner insulation balloon tube  109  and the interior of inner thermal insulation balloon  106 . Inner cryo balloon  105 , and inner thermal insulation balloon  106  are substantially elastic balloon, and are preferably made from a silicone rubber. Outer balloon  103  is substantially non-elastic, and is optically clear, and is preferably made from PET. The distal end of outer balloon  103  is bonded to the proximal end of distal tip  104  using adhesive  113 . The proximal end of outer balloon  103  is bonded to the distal end of probe shaft  102  using an adhesive  113 . The distal end of cryo balloon  105  is bonded to the distal end of cryogen balloon tube  107 , just proximal to distal tip  104  using adhesive  113 . The proximal end of inner cryo balloon  105  is bonded to the distal end cryogen vent tube  108  using adhesive  113  as shown. The distal end of inner thermal insulation balloon  106  is bonded to the distal end of inner insulation balloon tube  109  at its distal end just proximal to distal tip  104  using adhesive  113  as shown. The proximal end of inner insulation balloon  106  is bonded to inner insulation balloon tube  109  just distal to probe shaft  101  using adhesive  113  as shown. Adhesive  113  may be any suitable adhesive. Outer balloon  103  has a burst strength between approximately 4 and 12 atmospheres of pressure. Inner cryo balloon  105 , and inner thermal insulation balloon  106  have a burst strength of approximately 2 atmospheres of pressure or less. Cryo vent tube  108  and inner insulation balloon tube  109  are in fluidic communication at proximal terminal  110 . When liquid cryogen is introduced into inner cryo balloon  105  through cryogen nozzle array  111 , inner cryo balloon  105 , and inner thermal insulation balloon  106  are pressurized due to the evaporation of cryogen causing both inner cryo balloon  105 , and inner thermal insulation balloon  106  to be inflated and to conform to the inner surface of outer balloon  103 . The pressure of inflation is controlled by a pressure relief valve in proximal terminal  110 , and is described in further detail below. Outer balloon  103  may be inflated or deflated independently of the introduction of cryogenic liquid into inner cryo balloon  105 . The outer diameter of outer balloon  103  is between approximately 6 mm and 20 mm or more. The length of outer balloon  103  is between 1 cm and 6 cm or more. The dimensions of inner cryo balloon  105  and inner thermal insulation balloon  106  are sized so that both balloons are in conformity with the interior outer balloon  103  when pressurized. Inner cryo balloon  105  is configured to freeze tissue laterally in a radial segment of outer balloon  103  between approximately 90 and 270 degrees. Inner insulation balloon  106  is configured to prevent tissue freezing in a radial segment of outer balloon  103  between approximately 90 and 270 degrees. The radial segments of tissue freezing and tissue insulation may manipulated by the dimensions of inner cryo balloon  105  and inner thermal insulation balloon  106 , and manipulation of their material properties, including elasticity. Lateral optical probe  64  may be inserted into and withdrawn from outer balloon  103 , prior to a cryosurgical step, and after a cryosurgical step. 
       FIG.  10    is a cross section Illustration of IGCB probe  101  taken at section C-C of  FIG.  9 C . Probe shaft  102  may me substantially rigid and extruded of a surgical metal, or may be substantially flexible and extruded from a plastic material such as urethane, PeBax®, nylon or polyethylene. The diameter of probe shaft  102  is between approximately 2.5 and 3.5 mm. The length of probe shaft  102  is application specific and may range between 10 cm and 100 cm or more. Probe shaft  102  comprises outer balloon lumen  114 , inner thermal insulation balloon lumen  115 , imaging probe lumen  116 , and inner cryo balloon lumen  117 . Inner insulation balloon tube  109  resides within inner thermal insulation balloon lumen  115  for at least a portion of the length of probe shaft  102 . Inner insulation balloon tube  109  may be bonded within inner thermal insulation balloon lumen  115  with an adhesive. Lateral optical imaging probe  64  is configured to reside within optical imaging lumen  116 , and may be inserted and withdrawn form optical imaging lumen  116  from a port in proximal terminal  110 , which will be described in further detail below. Cryo tube  107  resides within cryo vent tube  108  in a coaxial relationship as shown. Cryo vent tube  108  resides within inner cryo balloon lumen  117  as shown. Inner cryo balloon tube  107 , and inner thermal insulation balloon tube  109  may be fabricated from a stainless steel of Nitinol® hypodermic tube. Cryo vent tube  108  may be fabricated from a plastic extrusion, or a metal hypodermic tube. The inner cross sectional area of inner cryo balloon tube  107  is approximately less than one half of the inner cross sectional area of cryo vent tube  108 . 
       FIG.  11    is a cross section schematic illustration of the distal end of IGCB probe  101  during a cryosurgical step. Lateral optical imaging probe  64  has been withdrawn from the interior of outer balloon  103 . Liquid cryogen  119  is shown being sprayed at the lateral wall of inner cryo balloon  105 . As a result of the evaporation of liquid cryogen  119  inner cryo balloon  105 , and inner insulation balloon  106  are inflated at a pressure controlled by a pressure relief valve in the proximal terminal  110  by evaporated cryogen gas  120 , into substantial conformance to the inner surface of outer balloon  103 . Ice ball  118  is formed within the tissue adjacent to inner cryo balloon  105 . Tissue adjacent to inner thermal insulation balloon  106  is spared from freezing, and therefore freezing injury. 
       FIG.  12    is a transverse cross sectional schematic illustration of IGCB probe  101  taken at section D-D of  FIG.  11   . Depicted is liquid cryogen  119  being sprayed at the inner wall of inner cryo balloon  105  by cryogenic nozzle array in inner cryo balloon tube  107 . As a result, liquid cryogen  119  evaporates at the surface of inner cryo balloon  107  forming cryogenic gas  120  that is maintained at a pressure sufficient to inflate inner cryo balloon  105  and inner thermal insulation balloon  106  into conformance with the interior of outer balloon  103  as show. 
       FIG.  13    is a schematic illustration of proximal terminal  110  of IGCB probe  101 . Hub  121  fluidically connects outer balloon lumen  114  to outer balloon lumen hub tube  122 , inner cryo balloon tube  107  to cryo balloon hub tube  123 , and provides an insertion path for optical probe  64  into optical probe lumen  116  though optical probe port  86  and optical probe hub tube  125 . Hub  121  is also configured to provide fluidic communication between inner cryo balloon lumen  117 , inner cryo balloon vent tube  108 , and inner thermal insulation balloon tube  109 , and hub cryo exhaust tube  126 . Hub  121  may be insert molded using mandrels to create discrete channels between the hub tubes and lumens described above. Those skilled in the art of surgical probe hub design and manufacture are familiar methods for designing and manufacturing the IGCB probe hub as disclosed here within, therefore no further description is warranted. Imaging probe port  124  may comprise a Toughy Borst connector, or another type of surgical pressure port. Imaging module  88  comprises a camera and a light source, and has been previously described in detail. Inner cryo balloon tube  107  is connected to a source of liquid cryogen  90  by means of cryogen port  127 , cryogen source hose  91 , and cryogen connector  92 . Liquid cryogen source  90  is depicted schematically as a cryogen tank. The liquid cryogen source may comprise a control console that controls the flow of cryogen based on user settings, and feedback from sensors, not shown. The liquid cryogen may be liquid carbon dioxide or liquid nitrogen, or a liquid chlorofluorocarbon compound. Alternatively, instead of using evaporative cooling, a Joules-Thompson effect (adiabatic gas expansion) cooling architecture could employed and still be within the scope of this invention. Nitrous oxide or argon gas would be the preferred cryogenic gasses for use if a Joule-Thompson cooling architecture is employed. Those skilled in the art cryosurgical probe design and manufacture are familiar the design attributes and trade-offs between liquid cryogen evaporative cooling and Joule-Thompson effect cooling architectures, and are familiar with the means for employing either cooling architecture within the scope of this invention, therefore no further discussion is warranted. Outer balloon lumen  114  is in fluidic communication with balloon lumen hub tube  122 . Syringe  128  provides the user a means to either inflate outer balloon  103  prior to or after a cryosurgical step. Pressure relief valve  129  vents evaporated cryogen  120  to the ambient atmosphere while maintaining a set pressure within inner cryo balloon  105  and inner thermal insulation balloon  106  during liquid cryogen delivery. The pressure created by pressure relief valve  129  is used to maintain inflation of inner cryo balloon  105  and inner thermal insulation balloon  106  in order to maintain their conformity with the interior surface of outer balloon  103 . Pressure relief valve  129  may have a fixed preset pressure relief setting, or pressure relief valve  129  may have a user adjustable pressure setting within a range of pressures that are lower than the burst strength of outer balloon  103 . Pressure relief valve  129  may also comprise an audible indication of the volumetric flow rate of evaporated cryogen  120  exiting pressure relief valve  129 . The audible indication may be in the form of a whistle where the pitch or volume of the whistle may increase as the flow rate of evaporated cryogen  120  increases. The audible signal may provide the user with an indication of tissue freezing effectiveness, or an indication of device failure, such as an inner cryo balloon  105  failure. 
       FIG.  14    is cross sectional schematic illustration of a cryo-ablation of the function of nerve  130  using IGCB probe  101 . As shown, IGCB probe  101  is positioned with balloon  103  inflated and separating nerve  130  from associated vein  131  and artery  132 . Inner cryo balloon  105  is positioned adjacent to nerve  130 . Liquid cryogen  119  is being sprayed against the inner wall of inner cryo balloon  105 , resulting in ice ball  118  forming in adjacent tissue and encompassing nerve  130 . Inner cryo balloon  105  and inner thermal insulation balloon  106  are inflated by evaporated cryogen gas  120  as previously described. Inner thermal insulation balloon  106  is adjacent to vein  131 , and artery  132  providing protective thermal insulation from cryogenic injury. 
     The applications of the disclosed invention discussed above are not limited to certain treatments or regions of the body, but may include any number of other treatments and areas of the body. Modifications of the above-described methods and devices for carrying out the invention, and variations of aspects of the invention that are obvious to those of skill in the arts are intended to be within the scope of this disclosure. Moreover, various combinations of aspects between examples are also contemplated and are considered to be within the scope of this disclosure as well.