Abstract:
A cryosurgical instrument that includes: an external shaft with a cryotip; a heat exchanger that cools a portion of the external shaft and the tip when cryogen is received thereby; and a flow diverter that receives a flow of cryogen, that splits the received flow of cryogen into two or more split cryogen flows, and that delivers the split cryogen flows to the heat exchanger, the flow diverter including a first passage with one or more inlet ports at an upstream side of the diverter that receive the flow of cryogen and two or more outlet ports at a downstream side of the diverter and in fluid communication with the heat exchanger.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims the benefit of priority from U.S. Provisional Patent Application No. 61/450,746, filed Mar. 9, 2011. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    Embodiments of the present invention relate to cryosurgical equipment, and, more particularly, to cryoprobes or cryocatheters that feature a flow diverter that directs the incoming flow of cryogen against the inner wall of the external shaft thereof. 
         [0004]    2. Description of Background Art 
         [0005]    This description of background art is intended to provide the basic context of this patent application. 
         [0006]    Cryoprobes that “boil” a liquid cryogen, when this liquid cryogen is supplied from an external source into the cryoprobe, are known for performing cryosurgical procedures. Generally, a cryogen is delivered into a cryoprobe in the form of a two-phase fluid, since a certain percentage of the liquid cryogen evaporates inevitably before entry to the cryoprobe as a result of imperfect thermal insulation of the delivery hose. This two-phase condition cannot easily be improved by separating the liquid and gaseous phases completely in the internal cavity of the cryotip (the distal section of the cryoprobe) without the implementation of special structures. In addition, in particular when nitrogen is used as a cryogen, the liquid nitrogen interacts with the solid, warmer surface by creating nitrogen gas cushion, known as Liedenfrost effect. This effect considerably reduces the ability to absorb heat from the warmer surface. Without addressing the problems caused by this cushion, it is impossible to take advantage of the boiling of the liquid fraction of the cryogen for effective freezing of a treated tissue. A more desirable solution would force the “boiling” of the liquid phase to take place as close as possible to the warmer surface. 
         [0007]    Attempted solutions to these problems associated with using nitrogen as the cryogen are known; all suffer from significant drawbacks, however, due to the nature of boiling nitrogen fluid flow. 
         [0008]    Joule-Thomson probes inherently operate such that the cryogen is delivered to an expansion chamber at the end of the tip, where it expands and cools. After cooling, the expanded and cooled cryogen then enters a return passage where it cools the external surface. When cooled by evaporation, the volume of the returning cryogen is considerably larger than the amount of cryogen initially supplied to the cryoprobe. Such an expanded volume of the return cryogen poses considerable difficulty for removal from the cryoprobe, due to the relatively small confines of the available exit(s) for exhausting the expanded cryogen. 
       BRIEF SUMMARY 
       [0009]    This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is neither intended to identify key features or essential features of the claimed subject matter nor is it intended to be used to limit the scope of the claimed subject matter. 
         [0010]    The background art does not provide a solution that overcomes the problem of exhausting a large, expanded volume of boiled, returning cryogen in the relatively small confines of the available exit(s) for exhausting the expanded cryogen. 
         [0011]    Applicants have discovered an advantageous solution to the problems of the background art by adding a flow diverter which directs the incoming cryogen, entering the cryoprobe, directly towards the surface of the warmer external wall, and then causes the boiled cryogen to be exhausted from the cryoprobe through an inner return passage. The boiling of the cryogen at the inner surface of the external shaft of the cryoprobe, where heat exchange occurs, increases in volume and then increases the speed of the flow of the cryogen considerably, thus increasing the heat transfer from the inner surface of the external shaft to the cryogenic fluid. Bringing the two-phase cryogen, which contains larger portion of liquid phase, directly into contact with the internal surface of the outer wall cryoprobe, reduces the overall volume of the cryogen that is present at the heat exchange zone (which is also termed herein a heat exchange element). The size of the cross sectional area of the return channel (or channels) that is available to the return cryogen depends on the diameter of the probe. 
         [0012]    At least one aspect of the present invention provides a cryosurgical instrument in which the flow diverter can be made of a rigid material such as metal or ceramic, or any other suitable material that maintains its structural integrity under the low temperature of the boiling cryogenic fluid and the resultant pressure of this material. 
         [0013]    At least one aspect of the present invention provides a cryosurgical instrument in which a cryoprobe tip, which is situated near or in a central feeding tube of the cryoprobe and which, among many advantages, solves the above technical problem. 
         [0014]    At least one aspect of the present invention provides a cryosurgical instrument in which the cryoprobe features a special tip, the flow diverting element and the heat exchanger, for forcing the cryogenic fluid to increase in speed and the liquid phase to come as close as possible to the inner surface of the external shaft. The special tip preferably features one or more mechanisms that increase the contact of the liquid phase with internal surface area of the external shaft and hence increase the heat transfer. 
         [0015]    The special tip, in some aspects, is optionally and preferably constructed as a metal pipe with a suitable diameter to be introduced into the distal section of the central feeding tube. The proximal section of the metal pipe is preferably provided with straight or helical grooves, holes, other diffusion elements, or surface indentations directed outwards, thereby enabling this element to function as either a flow directing element, or a spraying component. In addition, the distal section of the tip, which is situated outside the central feeding tube, provides a limited cross section to force the cryogen to flow within a small film immediately on the inner surface of the cryoprobe. 
         [0016]    Various implementations may optionally be used to install the special tip element in the central feeding tube. For example, the diameter of the element may optionally be of one tenth of a millimeter smaller than the inner diameter of the cryoprobe, such that the cryogenic fluid is directed toward the inner surface of the external shaft of the cryoprobe, then exhausted through an inner passage which acts as a return channel for the exhausted cryogen. 
         [0017]    In addition, the distal section of the element may optionally be attached to the inner surface of the external shaft of the cryoprobe. Optionally a plurality of helical grooves are not attached to the inner surface so as to provide space for the boiling process to occur close to the inner surface of the external shaft, while the remaining surface in contact absorbs the heat by conduction. 
         [0018]    One aspect of the present invention provides a cryosurgical instrument including: an external shaft with a cryotip at a distal end thereof; a cryogen supply tube at a proximal end of the external shaft, the supply tube supplying a cryogen to the instrument; a heat exchanger that cools a portion of the external shaft by directing the supplied cryogen against an inner surface of a portion of the external shaft and an inner surface of the tip and that guides exhausted cryogen away from the tip; and a flow diverter disposed between the cryogen supply tube and the heat exchanger. The flow diverter includes a first Y-configured passage with an inlet port at an upstream side of the diverter and a second Y-configured passage with an inlet port at a downstream side of the diverter, the first Y-configured passage receiving the supplied cryogen from the cryogen supply tube via the inlet port at the upstream side of the flow diverter and diverting the received cryogen to the heat exchanger in an downstream direction, and the second Y-configured passage receiving exhausted cryogen via the inlet port at the downstream side of the flow diverter and directing the received exhausted cryogen to an exhaust tube in a upstream direction. 
         [0019]    Another aspect of the present invention provides a cryosurgical instrument including: an external shaft with a cryotip; a heat exchanger that cools a portion of the external shaft and the tip when cryogen is received thereby; and a flow diverter that receives a flow of cryogen, that splits the received flow of cryogen into two cryogen flows, and that delivers the split cryogen flows to the heat exchanger, the flow diverter including a Y-configured passage with an inlet port at an upstream side of the diverter that receive the flow of cryogen and two outlet ports at a downstream side of the diverter and in fluid communication with the heat exchanger. 
         [0020]    Still another aspect of the present invention provides a cryosurgical instrument including: an external shaft with a cryotip; a heat exchanger that cools a portion of the external shaft and the tip when cryogen is received thereby; and a flow diverter that receives a flow of cryogen, that splits the received flow of cryogen into two or more split cryogen flows, and that delivers the split cryogen flows to the heat exchanger. The flow diverter includes a first passage with one or more inlet ports at an upstream side of the diverter that receive the flow of cryogen and two or more outlet ports at a downstream side of the diverter and in fluid communication with the heat exchanger. 
         [0021]    These, additional, and/or other aspects and/or advantages of the present invention are: set forth in the detailed description which follows; possibly inferable from the detailed description; and/or learnable by practice of the present invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0022]    The present invention will be more readily understood from the detailed description of embodiments thereof made in conjunction with the accompanying drawings of which: 
           [0023]      FIG. 1   a  is a longitudinal cross-section view of the cryoprobe consistent with an embodiment of the present invention, with a spiral heat-exchanging element, showing inlet passages of the flow-diverting element; 
           [0024]      FIG. 1   b  is a longitudinal cross-section view of the cryoprobe of  FIG. 1   a , with a spiral heat-exchanging element, showing outlet passages of the flow-diverting element; 
           [0025]      FIG. 1   c  is a front, perspective view of the flow diverter  106  of  FIGS. 1   a  and  1   b;    
           [0026]      FIG. 1   d  is a rear, perspective view of the flow diverter  106  of  FIGS. 1   a  and  1   b;    
           [0027]      FIG. 2   a  is longitudinal cross-section view of the cryoprobe consistent with an embodiment of the present invention, with external straight grooves provided for inlet flow, showing inlet passages of the flow diverter; 
           [0028]      FIG. 2   b  is longitudinal cross-section view of the cryoprobe of  FIG. 2   a  with external straight grooves provided for outlet flow; 
           [0029]      FIG. 2   c  is a lateral cross-section of the cryoprobe of  FIG. 2   a  along line A-A, with external grooves provided; and 
           [0030]      FIG. 3  is a longitudinal cross section of a cryoprobe consistent with an embodiment of the present invention, with a spiral heat exchanger. 
       
    
    
     DETAILED DESCRIPTION 
       [0031]    Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like reference numerals refer to the like elements throughout. The embodiments are described below to explain the present invention by referring to the figures. 
         [0032]    Although the following text sets forth a detailed description of at least one embodiment or implementation, it is to be understood that the legal scope of protection of this application is defined by the words of the claims set forth at the end of this disclosure. The detailed description is to be construed as exemplary only and does not describe every possible embodiment since describing every possible embodiment would be impractical, if not impossible. Numerous alternative embodiments and/or implementations are both contemplated and possible, using either current technology or technology developed after the filing date of this patent, which would still fall within the scope of the claims. 
         [0033]    It is to be understood that, unless a term is expressly defined in this application using the sentence “As used herein, the term” is hereby defined to mean . . . ” or a similar sentence, there is no intent to limit the meaning of that term, either expressly or by implication, beyond its plain or ordinary meaning, and such term should not be interpreted to be limited in scope based on any statement made in any section of this patent (other than the language of the claims). To the extent that any term recited in the claims at the end of this patent is referred to in this patent in a manner consistent with a single meaning, that is done for sake of clarity only so as to not confuse the reader, and it is not intended that such claim term by limited, by implication or otherwise, to that single meaning. Finally, unless a claim element is defined by reciting the word “means” and a function without the recital of any structure, it is not intended that the scope of any claim element be interpreted based on the application of 35 U.S.C. §112, sixth paragraph. 
         [0034]    The term “cryosurgical instrument” refers herein to any type of cryo-instrument including, but not limited to, cryoprobes and cryocatheters. Although the description centers around cryoprobes, this is for the purpose of illustration only and is without any intention of being limiting. 
         [0035]    Referring to  FIGS. 1   a - 1   d ,  FIG. 1   a  is a longitudinal cross-section of a cryoprobe  100  with a spiral heat exchanger, showing the inlet passages.  FIG. 1   b  is a longitudinal cross-section of the cryoprobe with a spiral heat exchanger, showing the outlet passages, which is a 90-degree rotational view of the view in  FIG. 1   a .  FIGS. 1   c  and  1   d  are perspective views of the flow diverter  106  of  FIGS. 1   a  and  1   b.    
         [0036]    The cryoprobe  100  comprises an external shaft  103  and, from upstream to downstream, a cryogen supply tube  102  at a proximal end of the cryoprobe, a flow diverter  106 , a heat exchanger  101 , and a tip  108  at a distal end of the cryoprobe. 
         [0037]    The cryogen supply tube  102  delivers cryogen to the cryoprobe  100  and may generally be disposed centrally, along a longitudinal axis (not shown) of the cryoprobe. The cryogen supply tube  102  is in fluid communication with the flow diverter  106 , which is in fluid communication with the heat exchanger  101 . 
         [0038]    The flow diverter  106  diverts the incoming flow of cryogen  114  from the cryogen supply tube  102  and is located within the external shaft  103 . In more detail, the flow diverter serves to direct the incoming flow from the center of the cryosurgical device to the outer surface of the cryosurgical device. That is to say to the inner surface of external shaft  103 . Preferably, the flow diverter  106  is centrally disposed along the longitudinal axis (not shown) of the cryoprobe  100 . This position encourages symmetrical delivery of the cryogen to the heat exchanger  101 , as explained below. 
         [0039]    The flow diverter  106  preferably comprises two-Y type (i.e., Y configured) passages  106   a ,  106   b  located in a 90-degree rotational relationship to one another and placed in opposite directions. This is to say that each of the passages has a single port at one end and two ports at another opposing other.  FIG. 1   a  shows the inlet fluid Y passage  106   a  and the  FIG. 1   b  shows the return fluid Y passage  106   b . This configuration is exemplary; other configurations are both contemplated and possible. 
         [0040]    For example, in one contemplated variation, instead of Y-type passages, the flow diverter  106  may have passages with a single, central inlet port and multiple (i.e., more than two) peripheral outlet ports. Further, these outlet ports may be spaced evenly around the periphery of the flow diverter to promote even diversion of the cryogen flow against the external shaft  103 . 
         [0041]    In another contemplated variation, the passages  106   a  and  106   b  of the flow diverter  106  need not share the same configuration. Also, the respective outlet ports of the passages  106   a  and  106   b  need not be circular. Rather, they may be elliptical or slotted. 
         [0042]    In yet another contemplated variation, the flow passages  106   a  and  106   b  of the flow diverter  106  may have multiple inlets and multiple outlets. 
         [0043]    In sum, the inventors contemplate multiple combinations of inlet ports and outlet ports of the flow passages, as well as multiple configurations of the passages, depending on, inter alia, desired performance and the flow and cooling properties of the specific cryogen being used. 
         [0044]    The heat exchanger  101  is located within an external shaft  103  and directs cryogen against an inner surface of external shaft  103 . To achieve this direction of the cryogen flow  114 , the heat exchanger is provided with a plurality of grooves  120 , of which two are shown for the purpose of description only, which are close to the inner surface of the external shaft  103 . The spiral grooves  120  spiral about the longitudinal axis of the cryoprobe  100  and are open to the inner surface of the external shaft  103 . That is to say that the grooves  120  are in fluid communication with the inner surface of the external shaft  103 . The two-phase cryogen flows in the spiral groove  120  and boils between the heat exchanger  101  and the inner surface of the external shaft  103 , increasing its speed and enhancing the heat transfer between the cryoprobe  100  and the cryogen. 
         [0045]    In operation, the cryogen supply tube  102  introduces cryogen into the device  100  and directs the flow  114  of the cryogen through an inlet port  112  and then into the inlet fluid Y passage  106   a  of the flow diverter  106 . Thereafter, the flow of cryogen passes through the inlet fluid Y passage  106   a  and into the heat exchanger  101 . 
         [0046]    Next, cryogen flows from the inlet fluid Y passage  106   a  to each of a plurality of open spiral grooves  120 . The spiral grooves  120  exhaust the spiraling flow of cryogen  115  against an inner surface  122  of the tip  108 . Then, the flow of cryogen, after being reflected by the inner surface  122 , enters the inner passage  109  within the heat exchanger  101 . After this reflection, the cryogen may be characterized as expanded/exhausted. 
         [0047]    Thereafter, the expanded cryogen enters a return port  110  of the flow diverter  106 , flows through return fluid Y passage  106   b  to a return passage  111  and then to the exhaust tube  107 . The exhaust tube  107  is located between an optional insulation sleeve  104  and the cryogen supply tube  102 . The insulation sleeve  104  is near the proximal end of the cryoprobe  100 . Thermal insulation sleeve  104  terminates the heat transfer (ablation) zone  105  of the cryoprobe  100 . 
         [0048]    The length of the cryoprobe  100  between the tip  108  and the insulation sleeve  104  defines an ablation zone  105 . That is to say the ablation zone  105  is defined by a non-insulated inner surface of the cryoprobe  100  that comes in contact with the boiling cryogen. 
         [0049]    Referring to  FIGS. 2   a - 2   c ,  FIG. 2   a  is longitudinal cross-section of a cryoprobe  200  with external straight grooves provided for inlet flow, showing the inlet passages.  FIG. 2   b  is a longitudinal cross-section of the cryoprobe  200  with external straight grooves provided for outlet flow, which is a 90-degree rotational view of the view in  FIG. 2   a .  FIG. 2   c  is a lateral cross-section of the cryoprobe  200  of  FIG. 2   a  along line A-A, showing the radial dispersal of the straight grooves of the heat exchanger. 
         [0050]    Elements with the same or similar function as elements in  FIGS. 1   a - 1   d  are identified by similar reference numbers. 
         [0051]    The cryoprobe  200  comprises a flow diverter  206 , and heat exchanger  201 , which ends at its distal end in a hollow, closed tip  208 . Cryoprobe  200  operates in a manner similar to that of cryoprobe  100  of  FIGS. 1   a - 1   d , except that heating exchanging element  201  features open linear grooves  221 , rather than the open spiral grooves  120  shown in  FIGS. 1   a  and  1   b .  FIG. 2   c  shows the configuration of exhaust tube  207  in more detail; a similar configuration may also be made for exhaust tube  107  of cryoprobe  100  as shown in  FIGS. 1   a - 1   d.    
         [0052]    The heat exchanger  201  is located within an external shaft  203  and directs cryogen against an inner surface of external shaft  203 . External shaft  203  is preferably insulated with an insulation sleeve  204 . Tip  208  closed the external shaft  203  at a distal end thereof. 
         [0053]    A central cryogen supply tube  202 , located at least partially within external shaft  203  at its proximal end, supplies a flow of cryogen  214  to a flow diverter  206 . This flow  214  enters the flow diverter  206  through an inlet port  212 . 
         [0054]    Flow diverter  206  preferably comprises two-Y type passages located in a 90-degree rotational relationship to one another, placed in opposite directions within external shaft  203 .  FIG. 2   a  shows the inlet fluid Y passage  206   a  and the  FIG. 2   b  shows the return fluid Y passage  206   b . This configuration is exemplary; other configurations are both contemplated and possible. 
         [0055]    In operation, cryogen flows from inlet port  212 , through the Y passage  206   a , to one of a plurality of external straight grooves  221 . The straight grooves  221  extend in parallel to the longitudinal axis of the cryoprobe  200  and are close to the inner surface of the external shaft  203 . The flow of cryogen  215  continues to the ends of the grooves  221  where the returning, expanded cryogen, is reflected by an inner surface of tip  208 , enters the inner passage of the heat exchanger  209 . The two-phase cryogen flows in the grooves  221  and boils between the heat exchanger  201  and the inner surface of the external shaft  203 , increasing its speed and enhancing the heat transfer between the cryoprobe  200  and the cryogen. 
         [0056]    Thereafter, the cryogen then enters a return port  210 , flowing through Y passage  206   b  to a return passage  211 , then to the exhaust tube  207 . The flow of the cryogen is indicated by reference numeral  213 . 
         [0057]      FIG. 3  is a longitudinal cross-section of a cryoprobe  300  consistent with another aspect of the present invention, with an internal spiral coil provided for outlet-flow by the arrangement of a heat exchanger  301 . Elements with the same or similar function as elements in  FIGS. 1   a - 1   d  are identified by similar reference numbers. 
         [0058]    In operation, the cryogen flow  314  enters from the cryogen supply tube  302  and enters a flow diverter  306 . The cryogen is forced through the gap between the heat exchanger  301  and the external shaft  303 , through an inlet port  312  from flow diverter  306 . Heat exchanger  301  is shown as featuring a spiral coil configuration spiraling about the longitudinal axis of the cryoprobe  300 . After cooling the surface of the external shaft  303  along the ablation zone  305 , the cryogen reaches the tip  308 . The cryogen is then reflected and, through one or more openings  310 , of which one is shown for the purpose of illustration only, the flow  313  enters into heat exchanger  301 , reaching the exhaust tube  307  via the return cryogen passage  311 . To prevent the return cryogen to flowing in a retrograde manner, preferably a filling element  316  fills the volume inside the spirals of the coils of the heat exchanger  301 . 
         [0059]    The exhaust tube  307  is located between an optional insulation sleeve  304  and the cryogen supply tube  302 . The insulation sleeve  304  is near the proximal end of the cryoprobe  300 . Thermal insulation sleeve  304  terminates the heat transfer zone  305  of the cryoprobe  300 . 
         [0060]    The length of the cryoprobe  300  between the tip  308  and the insulation sleeve  304  defines an ablation zone  305 . That is to say the ablation zone  305  is defined by a non-insulated inner surface of the cryoprobe  300  that comes in contact with the boiling cryogen. 
         [0061]    As the foregoing evidences, Applicants have discovered an innovative approach to directing an incoming flow of liquid cryogen in a cryosurgical device by adding a novel flow diverter. The flow diverter directs the incoming cryogen directly towards the surface of the external wall of the cryosurgical device, which is a relatively warm surface. This promotes boiling of the cryogen. Also, the flow diverter facilitates the exhaust of the boiled cryogen from the cryoprobe through an inner return passage in the element. 
         [0062]    Examples of various features/aspects/components/operations have been provided to facilitate understanding of the disclosed embodiments of the present invention. In addition, various preferences have been discussed to facilitate understanding of the disclosed embodiments of the present invention. It is to be understood that all examples and preferences disclosed herein are intended to be non-limiting. 
         [0063]    Although selected embodiments of the present invention have been shown and described individually, it is to be understood that at least aspects of the described embodiments may be combined. 
         [0064]    Also although selected embodiments of the present invention have been shown and described, it is to be understood the present invention is not limited to the described embodiments. Instead, it is to be appreciated that changes may be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and the equivalents thereof.