Patent Publication Number: US-2020275968-A1

Title: Cryoablation Devices And Related Methods

Description:
CROSS-REFERENCE TO RELATED APPLICATION(S) 
     This application claims priority to International PCT Application No. PCT/US18/51106, filed on Sep. 14, 2018, which claims the benefit under 35 U.S.C. § 119(e) to U.S. Provisional Application 62/558,498, filed Sep. 14, 2017 and entitled “Cryoablation Catheter and Related Methods,” which is hereby incorporated herein by reference in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The various embodiments herein relate to methods and ablation devices for treating gallbladder disease. 
     BACKGROUND OF THE INVENTION 
     Gallstone disease affects 20 million people annually in the United States and results in more than 200,000 surgical cholecystectomies being performed each year. 
     The standard of care for acute cholecystitis is the laparoscopic cholecystectomy. 
     Unfortunately, the complication rate in the elderly undergoing a cholecystectomy may be as high as 19%. Many of these complications arise from the need for general anesthesia and abdominal insufflation during laparoscopic cholecystectomy procedures. Physiologic changes that patients undergo during general anesthesia and abdominal insufflation may not be tolerated in elderly patients with multiple medical comorbidities. In addition, patients with a history of prior surgery may have intra-abdominal adhesions, making visualization of the gallbladder and surrounding structures more difficult during laparoscopy. 
     There is a need in the art for an improved methods and devices for use in treating patients with gallbladder disease. 
     BRIEF SUMMARY OF THE INVENTION 
     Discussed herein are various cryoablation devices for ablating a gallbladder. 
     In Example 1, a cryoablation device comprises an elongate body, an expandable balloon operably coupled to the elongate body, a conduit associated with the elongate body, and at least one first suction opening defined in the elongate body. The expandable balloon is configured to receive an ablation fluid, wherein the expandable balloon is further configured to be positionable within a gallbladder. The conduit is operably coupled to the expandable balloon such that the ablation fluid is transportable to the expandable balloon via the conduit. 
     Example 2 relates to the cryoablation device according to Example 1, wherein the elongate body is a cryoprobe body or a catheter body. 
     Example 3 relates to the cryoablation device according to Example 1, wherein the at least one first suction opening is defined in the elongate body distal to the expandable balloon. 
     Example 4 relates to the cryoablation device according to Example 1, wherein the at least one first suction opening is defined in the elongate body proximal to the expandable balloon. 
     Example 5 relates to the cryoablation device according to Example 1, further comprising at least one second suction opening defined in the elongate body, wherein the at least one first suction opening is defined in the elongate body distal to the expandable balloon and the at least one second suction opening is defined in the elongate body proximal to the expandable balloon. 
     Example 6 relates to the cryoablation device according to Example 1, wherein the ablation fluid is a cryogen. 
     Example 7 relates to the cryoablation device according to Example 6, wherein the cryogen is liquid cryogen or gas cryogen. 
     Example 8 relates to the cryoablation device according to Example 1, further comprising a cryogen lumen defined within the elongate body, wherein the cryogen lumen is configured to receive a cryogen, wherein the ablation fluid is a conductive fluid. 
     Example 9 relates to the cryoablation device according to Example 1, wherein the elongate body comprises a suction lumen defined therein, wherein the suction lumen is in fluidic communication with the at least one first suction opening. 
     Example 10 relates to the cryoablation device according to Example 1, wherein the conduit comprises a lumen defined within the elongate body, wherein the lumen is in fluidic communication with an interior of the expandable balloon. 
     Example 11 relates to the cryoablation device according to Example 1, wherein the expandable balloon comprises at least two lobes, wherein the two lobes are disposed radially adjacent to each other along a length of the elongate body, wherein the at least two lobes define gaps disposed therebetween. 
     Example 12 relates to the cryoablation device according to Example 11, wherein the at least one first suction opening comprises a plurality of at least one first suction openings defined along the length of the elongate body and within the gaps. 
     Example 13 relates to the cryoablation device according to Example 1, wherein the elongate body comprises a guidewire lumen defined within the elongate body. 
     Example 14 relates to the cryoablation device according to Example 1, wherein the expandable balloon comprises at least two lobes, wherein the two lobes are disposed axially adjacent to each other along a length of the elongate body. 
     In Example 15, a method of performing a gallbladder ablation comprises positioning a cryoablation device within a gallbladder, filling the expandable balloon with cryogen via the cryogen conduit, and causing the gallbladder to contract and thereby contact the expandable balloon by applying suction via a lumen within the elongate body and the at least one first suction opening. The cryoablation device comprises an elongate body, an expandable balloon operably coupled to the elongate body, a cryogen conduit associated with the elongate body, wherein the cryogen conduit is operably coupled to the expandable balloon, and at least one first suction opening defined in the elongate body.\ 
     Example 16 relates to the method according to Example 15, wherein the elongate body is a cryoprobe body or a catheter body. 
     Example 17 relates to the method according to Example 15, wherein the positioning the cryoablation device within the gallbladder further comprises advancing a guidewire into the gallbladder, and advancing the cryoablation device into the gallbladder over the guidewire. 
     Example 18 relates to the method according to Example 15, further comprising removing the cryogen from the expandable balloon, thereby causing the expandable balloon to contract, and retracting the cryoablation device from the gallbladder. 
     In Example 19, a cryoablation device comprises a cryogen probe comprising an elongate probe body, an elongate slidable body, at least one suction opening defined in an outer wall of the elongate slidable body, wherein the at least one suction opening is in fluid communication with the suction lumen, and a fluid tube coupled with the elongate slidable body, the fluid tube comprising a fluid tube lumen in fluid communication with the suction lumen of the elongate slidable body. The elongate slidable body comprises a probe lumen defined within the elongate slidable body, wherein the elongate slidable body is slidably positioned over the elongate probe body such that the elongate probe body is disposed within the probe lumen, and a suction lumen defined within the elongate slidable body. 
     Example 20 relates to the cryoablation device according to Example 19, wherein the at least one suction opening comprises a plurality of suction openings defined in the outer wall of the elongate slidable body. 
     Example 21 relates to the cryoablation device according to Example 19, wherein the elongate slidable body is an elongate sleeve. 
     Example 22 relates to the cryoablation device according to Example 19, further comprising a deployable retention structure disposed along a length of the elongate slidable body. 
     Example 23 relates to the cryoablation device according to Example 22, wherein the deployable retention structure comprises a deployed configuration and an undeployed configuration. 
     Example 24 relates to the cryoablation device according to Example 22, wherein the deployable retention structure comprises at least two hinged sections hingedly coupled to the outer wall of the elongate slidable body, wherein the at least two hinged sections are moveable between a deployed configuration and an undeployed configuration. 
     Example 25 relates to the cryoablation device according to Example 19, wherein the elongate slidable body comprises a substantially flexible material. 
     In Example 26, a method of performing a gallbladder ablation comprises positioning a cryoablation device within a gallbladder, filling the cryogen probe with cryogen via a cryogen conduit, and causing the gallbladder to contract and thereby contact the elongate slidable body by applying suction via the fluid tube, the suction lumen, and the at least one suction opening. The cryoablation device comprises a cryogen probe comprising an elongate probe body, an elongate slidable body slidably positioned over the elongate probe body, at least one suction opening defined in an outer wall of the elongate slidable body, wherein the at least one suction opening is in fluid communication with the suction lumen, and a fluid tube coupled with the elongate slidable body, the fluid tube comprising a fluid tube lumen in fluid communication with the suction lumen of the elongate slidable body. The elongate slidable body comprises a probe lumen defined within the elongate slidable body, wherein the elongate slidable body is slidably positioned over the elongate probe body such that the elongate probe body is disposed within the probe lumen, and a suction lumen defined within the elongate slidable body. 
     While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. As will be realized, the invention is capable of modifications in various obvious aspects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  is a perspective view of a cryoablation catheter, according to one embodiment. 
         FIG. 1B  is a perspective view of the cryoablation catheter of  FIG. 1A  with the balloon filled with cryogen. 
         FIG. 2  is a schematic view of the cryoablation catheter of  FIG. 1A  being inserted into a gallbladder, according to one embodiment. 
         FIG. 3  is a schematic view of the cryoablation catheter of  FIG. 1A  positioned within a gallbladder, according to one embodiment. 
         FIG. 4  is a schematic view of the cryoablation catheter of  FIG. 1A  positioned within a gallbladder with the balloon filled with cryogen and suction applied via the suction openings, according to one embodiment. 
         FIG. 5  is a perspective view of a cryoablation device, according to another embodiment. 
         FIG. 6A  is a side view of a slidable suction sleeve with a retention mechanism disposed over a cryoprobe, according to one embodiment. 
         FIG. 6B  depicts an expanded view of the retention mechanism of the suction sleeve of  FIG. 6A , according to one embodiment. 
         FIG. 6C  depicts a further expanded view of the retention mechanism of the suction sleeve of  FIG. 6B , according to one embodiment. 
         FIG. 7A  depicts a side view of a cryoprobe with an expandable balloon, according to one embodiment. 
         FIG. 7B  depicts a cross-sectional front view of the cryoprobe of  FIG. 7A , according to one embodiment. 
         FIG. 8  depicts a side view of a flexible, slidable suction sleeve disposed over a cryoprobe, according to another embodiment. 
         FIG. 9A  depicts a side view of a cryoprobe with an expandable balloon in its uninflated state, according to a further embodiment. 
         FIG. 9B  depicts a side view of the cryoprobe with the expandable balloon of  FIG. 9A  in its inflated state, according to one embodiment. 
         FIG. 9C  depicts a side view of the cryoprobe with the expandable balloon of  FIG. 9A  in its uninflated state after the cryoprobe has been advanced into a patient&#39;s gallbladder, according to one embodiment. 
         FIG. 9D  depicts a side view of the cryoprobe with the expandable balloon of  FIG. 9A  in its inflated state after the cryoprobe has been advanced into the patient&#39;s gallbladder, according to one embodiment. 
         FIG. 10A  depicts a side view of a method of using a cryoprobe in which a guidewire is first inserted through the gallbladder, according to one embodiment. 
         FIG. 10B  depicts a side view of the method of using a cryoprobe as depicted in  FIG. 10A  in which the cryoprobe with an uninflated balloon has been advanced over the guidewire into the gallbladder, according to one embodiment. 
         FIG. 10C  depicts a side view of the method of using a cryoprobe as depicted in  FIG. 10A  in which the balloon has been inflated in the gallbladder, according to one embodiment. 
         FIG. 11  depicts a side view of a cryoprobe with an expandable balloon that includes two or more lobes (or two or more balloons), according to another embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     The various embodiments disclosed or contemplated herein relate to cryoablation device embodiments and related methods for use in minimally invasive gallbladder ablation procedures. The various embodiments utilize a combination of cryoablation and/or suction to maximize the contact between the cryogen and the gallbladder wall while minimizing the size of the cryoablation zone, thereby reducing the risks of damage to other tissues during the procedure. The implementations herein allow for a minimally invasive gallbladder therapy that can be performed under moderate sedation, instead of general anesthesia. 
       FIGS. 1A and 1B  depict a cryoablation device  10 , according to one embodiment. This device  10  is a catheter  10  that has a catheter body  12  (which in this specific example is an elongate tube  12 ), a cryoablation balloon  14 , suction openings  16 , and a cryogen conduit  18 . 
     In one implementation, the catheter body  12  is made of thermoplastic elastomers (TPE), such as polyether block amide (PEBA), or other polymers. Alternatively, the catheter tube  12  can be made of any known material for a catheter used in interventional radiology. It is understood that any catheter body in any implementation disclosed or contemplated herein can be made of the same or similar materials. 
     The cryoablation balloon  14  is coupled to, positioned on, or otherwise associated with the body  12  such that the balloon  14  can have both an uninflated state and an inflated or filled state in which the balloon  14  is filled with a cryogen. More specifically,  FIG. 1A  depicts the balloon  14  in its uninflated state, while  FIG. 1B  shows the balloon  14  in its filled state. In the specific implementation of  FIGS. 1A and 1B , the balloon  14  is spaced from the distal end  20  of the body  12  such that there are suction openings  16  defined in the length of the body  12  between the balloon  14  and the distal end  20 . Alternatively, the balloon  14  can be positioned adjacent to the distal end  20  of the body  12 . In a further alternative, the balloon  14  can be positioned anywhere along the length of the catheter body  12 . The balloon  14  can be made of polyurethane, polypropylene, polyimide, or any other known biocompatible plastics that can be used in such devices. Alternatively, the balloon  14  can be made of any known flexible or elastic material that can be used in medical device balloons for insertion into a patient and can function in the cold temperatures of a cryogen. It is understood that any balloon in any implementation disclosed or contemplated herein can be made of the same or similar materials. 
     In accordance with one implementation, the cryogen is a gas cryogen or liquid cryogen. For example, in one specific embodiment, the cryogen is nitrogen, helium, neon, or argon. Alternatively, the cryogen can be any known gas or liquid cryogen for use in medical procedures. It is understood that any device according to any implementation disclosed or contemplated herein can use the same or a similar cryogen. 
     In one embodiment, the balloon  14  is configured to expand to a size of about 50×30×30 mm. Alternatively, the expanded or filled balloon  14  can have a diameter that ranges from about 10 mm to about 70 mm. 
     The suction openings  16  are defined in the tubular wall  22  of the catheter body  12  such that the openings  16  create fluidic communication between the lumen  24  of the catheter body  12  and the exterior area immediately adjacent to the body  12  and openings  16 . In the specific embodiment depicted in  FIGS. 1A and 1B , there are openings  16  defined in the body  12  along a length distal to the balloon  14  and along a length proximal to the balloon  14 . Alternatively, the openings  16  could be defined along the length of the body  12  solely distally of the balloon  14  or solely proximally of the balloon  14 . In this embodiment, it is understood that an external suction source (not shown) is provided that is operably coupled with the device  10  such that it is in fluidic communication with the lumen  24 , thereby creating a vacuum in the lumen  24  that causes suction at the openings  16 . It is understood that any known device for creating a vacuum in a medical device can be used. It is further understood that any such vacuum source can be used with any of the various embodiments disclosed or contemplated herein that include suction. 
     The cryogen conduit  18 , according to one embodiment as shown, is coupled to the tubular wall  22  of the catheter body  12  and extends from a proximal end (not shown) to the balloon  14 . The distal end of the conduit  18  is coupled to the balloon  14  such that the inner lumen  30  of the conduit  18  is in fluid communication with the interior of the balloon  14 . In the implementation depicted in  FIGS. 1A and 1B , the conduit  18  is coupled to an exterior portion of the tubular wall  22 . Alternatively, the conduit  18  is positioned within the lumen  24  of the catheter body  12 . The conduit  18  is used to transport cryogen from an exterior cryogen source (not shown) distally into the balloon  14 .  FIG. 1B  depicts the balloon  14  filled with cryogen that was transported via the conduit  18 . 
     In accordance with an alternative implementation, instead of inflating or filling the balloon  14  with cryogen, the catheter body  12  (or a portion thereof) is filled with cryogen and the balloon  14  is filled with a conductive fluid such that the cryogen in the catheter body  12  causes the conductive fluid in the balloon  14  to cool to a temperature that is sufficient for the balloon  14  to cryoablate the gallbladder according to any of the methods described or contemplated herein. In such an embodiment, the conduit  18  would be used to fill the balloon  14  with the conductive fluid, and the catheter body  12  would have at least two lumens (not shown), a first lumen in fluid communication with the openings  16  and configured to apply suction thereto, and a second lumen that can be filled with cryogen. 
     In use as best shown with reference to  FIGS. 2-4 , the cryoablation catheter  10  can be inserted into the gallbladder and perform the ablation using the following steps. 
     According to one embodiment, a guidewire  40  is first inserted into the gallbladder  44 . More specifically, a needle is first used to puncture a hole in the gallbladder  44 , and then the guidewire  40  is inserted through the needle and into the gallbladder as desired. The needle is then removed (with the guidewire  40  still in place) and the catheter  10  is then advanced over the guidewire  40  and positioned in the gallbladder  44 . In one embodiment as shown in  FIG. 2 , the catheter  10  is positioned in a sheath  42  before being advanced into the patient over the guidewire  40  and into the gallbladder  44 . Alternatively, the sheath  42  can first be advanced over the guidewire  40  and positioned within the gallbladder  44  and then the catheter  10  can subsequently be advanced over the guidewire  40  and into the sheath  42 . Once the catheter  10  is positioned as desired, the sheath  42  is removed, as best shown in  FIG. 3 . Alternatively, a sheath  42  is not used. In one embodiment, the guidewire is a standard 0.035 inch guidewire. Alternatively, any known guidewire for catheter devices can be used. In a further alternative, the device  10  can be inserted without a guidewire. 
     As shown in  FIG. 4 , once the catheter  10  is positioned as desired, the balloon  14  is filled with gas or liquid cryogen such that the balloon  14  expands, and suction is applied to the inside of the gallbladder  44  via the catheter lumen  24  and the suction openings  16 . The suction reduces the pressure within the gallbladder  44  (in comparison to the pressure outside the gallbladder  44 ) such that the gallbladder contracts and the wall of the gallbladder adheres to the balloon  14 . In one embodiment, the balloon  14  is filled with cryogen before the suction is applied via the suction openings  16 . The combination of the expanded balloon  14  filled with cryogen and the contraction of the gallbladder  44  and adherence to the balloon  14  (as a result of the suction) optimizes the effect of the cryogen on the gallbladder  44 . That is, the balloon  14  expansion ensures that a substantial cryogenic zone is created while the application of suction maximizes the amount of gallbladder  44  wall that makes contact with the balloon  14 , thereby optimizing the effectiveness of the device for purposes of the ablation. 
     Alternatively, in the implementations in which the cryogen is disposed in the catheter body  12  and a conductive fluid is used to fill the balloon  14 , once the catheter  10  is positioned as desired, a cryogen lumen (not shown) in the catheter body  12  is filled with gas or liquid cryogen and the balloon  14  is filled with a conductive fluid such that the balloon  14  expands, and suction is applied to the inside of the gallbladder  44  via the suction lumen (not shown) and the suction openings  16 . The suction reduces the pressure within the gallbladder  44  (in comparison to the pressure outside the gallbladder  44 ) such that the gallbladder contracts and the wall of the gallbladder adheres to the balloon  14 . In one embodiment, the balloon  14  is filled with the conductive fluid before the suction is applied via the suction openings  16 . The combination of the lumen of the catheter body  12  filled with cryogen, the expanded balloon  14  filled with conductive fluid, and the contraction of the gallbladder  44  and adherence to the balloon  14  (as a result of the suction) optimizes the effect of the conductive fluid on the gallbladder  44 . 
       FIG. 5  depicts another implementation of a cryoablation device  50 . This particular device  50  has a cryoablation probe  52  with an elongate probe body  54  and a slidable suction catheter (also referred to herein as a “sleeve”)  56  that is positionable over the probe body  54  such that the sleeve  56  is slidable along the length of the body  54 . The slidable suction sleeve  56  has a catheter or sleeve body  58  with a tubular wall  60  having suction openings  62  defined therein and an inner lumen  64 . Further, the suction sleeve  56  has a fluid tube  66  coupled to the catheter body  58 . The fluid tube  66  has a lumen  68  defined therein that is in fluid communication with the inner lumen  64  of the sleeve body  58  and has a tube port (or “suction port”)  70  at its proximal end. The probe  52  has cryogen tube  72  extending from a proximal end of the probe body  54 , wherein the tube  72  has a cryogen port  74  at the proximal end of the tube  72 . Further, the probe body  54  has an inner lumen  76  configured to receive cryogen. 
     The slidable suction sleeve  56  is slidably positioned over the probe body  54  such that the sleeve  56  can be moved distally or proximally along the body  54 . The suction openings  62  defined in the tubular wall  60  of the sleeve  56  create fluidic communication between the inner lumen  64  of the sleeve  56  and the exterior area immediately adjacent to the sleeve  56  and openings  62  such that any vacuum or lowering of air pressure within the inner lumen  64  can cause suction at the suction openings  62  similar to that discussed with respect to the prior embodiment. According to one implementation, there are openings  62  all along the length of the catheter body  58 . Alternatively, the openings  62  could be defined along only a distal portion of the catheter body  58  or only along a proximal portion of the body  58 . It is understood that the openings  62  can be defined anywhere along the length of the catheter body  58 . 
     In one embodiment, the vacuum or lower air pressure within the inner lumen  64  is caused by suction applied by a suction device (not shown) coupled to the suction port  70  on the fluid tube  66 , which decreases air pressure within the fluid tube  66 , which thereby decreases air pressure in the inner lumen  64 , thereby causing a suction action at the suction openings  62 . 
     In one implementation, the sleeve body  58  is made of polyvinylchloride, nylon, or polyurethane. Alternatively, the catheter body  58  is made of any known polymer, or combination of polymers, that can be used in a medical device catheter body. In a further alternative, the catheter body  58  can be made of any known material for a catheter used in interventional radiology. 
     The probe  52 , in accordance with one embodiment, is a known, conventional cryoprobe. For example, in one embodiment, the cryoprobe can be the R3.8 cryoprobe, which is commercially available from Endocare, Inc., which is part of Healthtronics, Inc. of Austin, Tex. Alternatively, the probe  52  can be a customized cryoprobe. In various embodiments, a cryogen source is coupled to the cryogen port  74  and thereby supplies cryogen to the inner lumen  76  of the probe body  54 . 
     In use, the cryoablation device  50  can be inserted into the gallbladder and perform the ablation using the following steps. 
     According to one embodiment, the probe body  54  is first inserted into the gallbladder in a fashion similar to the insertion of a guidewire. More specifically, the probe body  54  can have, according to certain embodiments, a sharp distal end  78  of the body  54  that can be used to puncture a hole in the gallbladder, and then the probe body  54  is inserted through the hole and into the gallbladder as desired. At this point, the sleeve  56  has previously been positioned over the probe body  54  or is now positioned over the probe body  54 . Regardless, the sleeve  56  is now advanced distally over the probe body  54  and positioned in the gallbladder. Alternatively, the probe body  54  can be configured to be positionable over a guidewire such that a guidewire (not shown) is first inserted into the gallbladder and then the probe body  54  is subsequently advanced into position in the gallbladder over the guidewire. In a further alternative, the sleeve  56  can be inserted over a guidewire (prior to the probe  52 ). According to one embodiment, a tapered inner dilator can be used to facilitate smooth insertion. Once the sleeve  56  is inserted as desired, the dilator can be retracted (if such a dilator is used) and the probe  52  is inserted into and through the sleeve  56  such that the probe  52  and sleeve  56  are disposed within the gallbladder as desired. 
     Once the probe body  54  and sleeve  56  are positioned as desired, the probe body  54  is filled with gas or liquid cryogen, thereby significantly lowering the temperature of the probe body  54 . In addition, suction is applied to the inside of the gallbladder via the catheter inner lumen  64  and the suction openings  62 . The suction can be applied before, at the same time as, or after the provision of the cryogen. As discussed above with the previous embodiment, the suction reduces the pressure within the gallbladder (in comparison to the pressure outside the gallbladder) such that the gallbladder contracts and the wall of the gallbladder adheres to the sleeve  56 . The combination of the probe body  54  filled with cryogen and the contraction of the gallbladder and adherence to the sleeve  56  (as a result of the suction) optimizes the effect of the cryogen on the gallbladder. That is, the application of suction maximizes the amount of gallbladder wall that makes contact with the sleeve  56 , thereby optimizing the effectiveness of the device for purposes of the ablation. 
       FIGS. 6A-6C  depict a further embodiment of a system  90  that includes suction sleeve  92  for use with a cryoablation probe  94 . It is understood that the cryoablation probe  94  can be substantially the same probe as the probe  52  discussed above with respect to  FIG. 5  and thus will not be specifically discussed herein. In this implementation, the slidable suction sleeve  92  is substantially similar to the sleeve  56  discussed above except as to the additional features discussed herein. More specifically, in addition to a sleeve body  96  with an inner lumen  98  and a tubular wall  100  having suction openings  102  and other components and features similar to the sleeve  56  discussed above, the sleeve body  96  in this specific implementation has a deployable retention structure  104  disposed along the length of the sleeve body  96 . The retention structure  104  is typically disposed at a location that is closer to the proximal end of the sleeve body  96  than the distal end. Alternatively, the retention structure  104  can be disposed anywhere along the length of the body  96 . 
     In the specific exemplary embodiment depicted in  FIGS. 6A-6C , the deployable retention structure  104  is made up of two hinged sections  106 A,  106 B,  108 A,  108 B on opposing sides of the sleeve body  96  that are coupled to each other and the sleeve body  96  via joints or hinges  110 A,  110 B,  110 C,  112 A,  112 B,  112 C on each side of each section. As such, the hinged sections can be deployed into two protrusions (also referred to herein as “ridges”)  114 ,  116  that protrude out from the sleeve body  96  as best shown in  FIGS. 6A and 6C . More specifically, the hinged sections  106 A,  106 B,  108 A,  108 B can be deployed to form the protrusions  114 ,  116  by urging the distal and proximal ends of the sleeve body  96  toward each other as shown by arrows A in  FIG. 6A , thereby causing the hinged sections  106 A,  106 B,  108 A,  108 B to begin to rotate in relation to each other at the hinges  110 A,  110 B,  110 C,  112 A,  112 B,  112 C toward the deployed configuration as shown. 
     Alternatively, the deployable retention structure  104  can be a deployable flange, a deployable disc, an inflatable annular balloon disposed around the sleeve body  96 , or any other similar feature or mechanism that can be deployed into a retention structure. 
     In use, like the cryoablation system  50  discussed above, the probe  94  can be preloaded with the suction sleeve  92 . That is, the suction sleeve  92  can be slidably positioned on the probe  94  prior to the procedure. It is understood that the various steps for use of this system  90  are substantially similar to the steps described above with respect to the system  50 , except as described herein. More specifically, once the probe  94  and sleeve  92  are positioned as desired in the gallbladder, the deployable retention structure  104  can be deployed as discussed above, thereby helping to retain the sleeve  92  within the gallbladder because the retention structure  104  has a diameter that is greater than the incision or opening in the gallbladder, thereby helping to prevent the sleeve  92  from inadvertently sliding proximally out of the gallbladder. Once the ablation procedure is complete, the retention structure  104  can be urged back into its undeployed configuration prior to retraction of the probe  94  and sleeve  92  from the gallbladder. 
     Another embodiment of a cryoablation device  130  is depicted in  FIGS. 7A and 7B , which show a cryoablation probe  130 . This probe  130  has an elongate probe body  132  with a tubular wall  134  having suction openings  136  defined therein. Further, the probe body  132  has two lumens defined therein: a suction lumen (not shown) in fluid communication with the suction openings  136  and a cryogen lumen disposed along a length of the body  132 . The suction lumen (not shown) is also in fluid communication with the suction tube  138  extending from a proximal end of the probe  130 , and the cryogen lumen (not shown) is in fluid communication with the cryogen tube  140  which also extends from the proximal end of the probe  130 . 
     The probe  30  also has a cryoablation balloon  142  that is coupled to, positioned on, or otherwise associated with the body  132  such that the balloon  142  can have both an uninflated state and an inflated or filled state in which the balloon  142  is filled with a cryogen, as best shown in  FIGS. 7A and 7B . In this specific implementation, the balloon  142  has three lobes  142 A,  142 B,  142 C as best shown in  FIG. 7B . Alternatively, the balloon  142  can have two lobes, four lobes, five lobes, or any other number of lobes. In a further alternative, instead of two or more lobes, the balloon  142  is actually made up of two or more balloons. The suction openings  136  are defined in the tubular wall  134  such that they are disposed within the clefts (also referred to as “gaps” or “spaces”)  144  between the lobes  142 A,  142 B,  142 C (or balloons) as shown in  FIG. 7B . As a result, the suction openings  136  are in fluid communication with the balloon clefts  144  and surrounding area adjacent the clefts  144 . 
     According to one embodiment, the suction openings  136  are disposed along the probe body  132  at or near the distal end of the body  132  and along a length of the body  132  substantially equal to the length of the balloon  142  and adjacent to the balloon  142  such that there are suction openings  136  along the full length of each cleft  144  in the balloon  142 . Alternatively, the suction openings  136  can extend beyond the length of the balloon  142 . In a further alternative, it is understood that the openings  136  can be defined anywhere along the length of the body  132 . In certain alternatives, the balloon  142  can be positioned anywhere along the length of the probe body  132 . The balloon  14  can be made of any of the materials described elsewhere herein for any of the balloon embodiments or any other known flexible or elastic material that can be used in medical device balloons for insertion into a patient and can function in the cold temperatures of a cryogen. Further, the cryogen can be any cryogen described with respect to any embodiment herein or any other known gas or liquid cryogen for use in medical procedures. 
     In this embodiment, it is understood that an external suction source (not shown) is provided that is operably coupled with the device  130  such that it is in fluidic communication with the suction lumen via the suction tube (or “conduit”)  138 , thereby creating a vacuum in the lumen (not shown) that causes suction at the openings  136 . It is understood that any known device for creating a vacuum in a medical device can be used. 
     The cryogen tube (or “conduit”)  140 , according to one embodiment as shown, is in fluidic communication with the cryogen lumen (not shown), as discussed, which in turn is in fluidic communication with the interior of the balloon  142 . The tube  140  and lumen are used to transport cryogen from an exterior cryogen source (not shown) distally into the balloon  142 . 
     In accordance with an alternative implementation, instead of inflating or filling the balloon  142  with cryogen, the cryogen lumen (not shown) is filled with cryogen and the balloon  142  is filled with a conductive fluid such that the cryogen in the probe body  132  causes the conductive fluid in the balloon  142  to cool to a temperature that is sufficient for the balloon  142  to cryoablate the gallbladder according to any of the methods described or contemplated herein. In such an embodiment, a separate lumen (and tube) (not shown) would be used to fill the balloon  142  with the conductive fluid, and thus the body  132  would have at least three lumens: a cryogen lumen (not shown), a suction lumen (not shown), and a conductive fluid lumen (not shown). 
     The probe  130 , in accordance with one embodiment, is a known, conventional cryoprobe as described elsewhere herein that has been modified as described herein. Alternatively, the probe  130  can be a customized cryoprobe having the features and components described herein. 
     In use, the cryoablation probe  130  can be inserted into the gallbladder and perform the ablation using steps similar to those described above with respect to the catheter device having a cryoballoon and suction openings. In one embodiment, the probe  130  can be inserted into the gallbladder using a guidewire, or, alternatively, it can be inserted without a guidewire. Once the probe  130  is positioned as desired, the balloon  142  is filled with cryogen and suction is applied via the suction openings  136  in a fashion similar to the methods described elsewhere herein, with the same results and benefits as described therein. 
       FIG. 8  depicts a further embodiment of a system  150  that includes a suction sleeve  152  for use with a cryoablation probe  154 , which in this case is a flexible, curved cryoablation probe  154 . More specifically, the probe  154  in this embodiment is a known probe having a probe body  156  with a flexible, curved configuration. In this implementation, the slidable suction sleeve  152  is substantially similar to the sleeve  56  discussed above except as to the additional features discussed herein. More specifically, the sleeve  152  in this implementation has a flexible sleeve body  158  that is configured to conform to the shape of the probe body  156  in a fashion similar to that shown in  FIG. 8  while still having suction openings  160  defined therein in a fashion identical or similar to the system  50  described above. 
     In use, this system  150  can operate in a fashion similar to the system  50  discussed above. That is, it is understood that the various steps for use of this system  150  are substantially similar to the steps described above with respect to the system  50 . 
     Another embodiment of a cryoablation device  180  is depicted in  FIGS. 9A-9D , which show a cryoablation probe  180  having a probe body  182  and an inflatable cryoballoon  184 . In accordance with one implementation, the probe body  182  has a cryogen lumen (not shown) defined therein and further has a conductive fluid conduit  186  disposed along a length of the body  182 , and more specifically disposed along an outer surface of the body  182 . The conductive fluid conduit  186  is in fluidic communication with an interior of the inflatable balloon  184  such that conductive fluid can be transferred along the conduit  186  to fill the balloon  184  as will be described in additional detail below. Alternatively, the conductive fluid conduit  186  can be disposed along an inner surface or other inner portion of the body  182 , and thus can, in certain embodiments, constitute a conductive fluid lumen  186 . The cryogen lumen (not shown) is substantially similar to the cryogen lumen in any known cryoprobe and allows for circulation of cryogen within the lumen to allow for the cryoprobe to perform an ablation. 
     The probe body  182  can also have a guidewire lumen (not shown) therein, such that the body  182  can be advanced over a guidewire in certain implementations. In one implementation, the body  182  is made of one or more metals, ceramics, plastics, or other known materials. Alternatively, the probe body  182  can be made of any known material for a probe used in interventional ablation. According to one embodiment, the distal tip of the body  182  is sharp. Alternatively, the tip is blunt. Further, the body  182  can be substantially rigid, or alternatively can be fairly flexible or compliant. It is understood that any probe body in any implementation disclosed or contemplated herein can be made of the same or similar materials and/or have the same or similar features or components. 
     The cryoablation balloon  184  is coupled to, positioned on, or otherwise associated with the body  182  such that the balloon  142  can have both an uninflated state (as best shown in  FIG. 9A ) and an inflated or filled state in which the balloon  142  is filled with the conductive fluid (as best shown in  FIG. 9B ). The balloon  184  can be made of polyurethane, polyethylene, nylon, latex, PVC, polypropylene, polyimide, or any other known biocompatible polymers or plastics that can be used in such devices. Alternatively, the balloon  184  can be made of any known flexible or elastic material that can be used in medical device balloons for insertion into a patient and can function in the cold temperatures of a cryogen. It is understood that any balloon in any implementation disclosed or contemplated herein can be made of the same or similar materials. 
     The conductive fluid that can fill the balloon  184  can be biocompatible, have a low freezing point, and have the ability to transmit cold temperatures. In certain implementations, the fluid can be mono-propylene glycol, mono-ethylene glycol, glycerol, and linseed oil. Alternatively, any known conductive fluid for use in a cryoablation device can be used. It is understood that the conductive fluid in any other embodiment disclosed or contemplated herein can be made of the same or similar materials and/or have the same or similar features. 
     According to one alternative embodiment, the device  180  can have suction openings (not shown) and provide suction in the same fashion as any of the other embodiments herein. 
     The probe  180 , in accordance with one embodiment, is a known, conventional cryoprobe as described elsewhere herein that has been modified as described herein. Alternatively, the probe  180  can be a customized cryoprobe having the features and components described herein. 
     In use, as best shown in  FIG. 9C , the cryoablation probe  180  can first be inserted into the gallbladder  188  with the balloon  184  in its uninflated state. Once the probe  180  is positioned as desired (with the balloon  184  fully within the gallbladder), the balloon  184  can be inflated by providing conductive fluid via the conduit  186 , as best shown in  FIG. 9D . At the same time (or before or after filling the balloon  184 ), the cryogen is supplied to the cryogen lumen (not shown) in the cryoprobe body  182 , thereby beginning the process of freezing the probe body  182  and thereby causing the temperature of the conductive fluid to lower to the point that the balloon  184  can ablate the gallbladder. 
     Alternatively, the probe  180  can be used in a similar procedure to that described above, except that it is first inserted over a guidewire. That is, as best shown in  FIG. 10A , a guidewire  190  is first inserted percutaneously through the gallbladder. Further, in one embodiment, the guidewire  190  is manipulated or steered along the cystic duct  192  and the bile duct  194  as shown. The probe  180  is than advanced over the guidewire  190 , with the guidewire being disposed within the guidewire lumen (not shown) in the probe such that the probe  180  can advance over it. The probe  180  is advanced until it is disposed as desired in the gallbladder  188  with the balloon  184  in its uninflated state, as best shown in  FIG. 10B . The balloon  184  is then inflated with the conductive fluid via the conduit  186 , as best shown in  FIG. 10C . Once the ablation is complete, the balloon  184  can be deflated and the probe  180  and guidewire  190  can be retracted. 
     In a further alternative embodiment as shown in  FIG. 11 , the cryoablation probe  200  can have substantially the same components and features as set forth above with respect to probe  180 , except as to the specific differences described herein. More specifically, the probe  200  has an inflatable balloon  202  that is made up of at least two lobes  202 A,  202 B formed by a constraint therebetween or some other similar structure (or, alternatively, to two or more separate balloons  202 A,  202 B). Alternatively, the number of lobes (or separate balloons) can be three, four, five, six, or more. In this specific example, the distal lobe  202 B is smaller than the proximal lobe  202 A. According to one embodiment, the specific lobe sizes can be used to design or contour the ablation balloon(s)  202  to better match with the target tissue, thereby resulting in a more focused and controlled ablation. For example, the smaller lobe  202 B is sized to match the amount or size of the target tissue at the end of the gallbladder that the distal lobe  202 B is intended to contact, thereby reducing the risk of over-ablation or unwanted damage to surrounding tissues. It is understood that the two or more lobes or balloons can be configured in any combination of sizes and configurations to achieve the desired shape and ablation. 
     Although the present invention has been described with reference to preferred embodiments, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.