US20200121498A1 - Cryogenic System and Method of Use - Google Patents

Abstract

A cryogenic medical device for delivery of subcooled liquid cryogen to various configurations of cryoprobes is designed for the treatment of damaged, diseased, cancerous or other unwanted tissues. The device is a closed or semi-closed system in which the liquid cryogen is contained in both the supply and return stages. The device is capable of generating cryogen to a supercritical state and may be utilized in any rapid cooling systems. As designed, the device comprises a number of parts including a vacuum insulated outer dewar, submersible cryogen pump, baffled linear heat exchanger, multiple pressurization cartridges, a return chamber, and a series of valves to control the flow of the liquid cryogen interconnected with cryotreatment devices including cryoprobes and catheters. The cryogenic medical device promotes subcooling to the tips of various external cryogenic instrument configurations.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of U.S. patent application Ser. No. 15/445,968, filed Feb. 28, 2017, which is a continuation of U.S. patent application Ser. No. 14/336,317, filed Jul. 21, 2014, which is a continuation of U.S. patent application Ser. No. 13/061,171, filed Feb. 28, 2011, which is a National Stage entry of International Patent Application Ser. No. PCT/US2009/62928, filed Nov. 2, 2009, and is a continuation of U.S. patent application Ser. No. 12/553,005, filed Sep. 2, 2009, which claims priority to U.S. Provisional Patent Application Ser. No. 61/093,916, filed Sep. 3, 2008; and further is a continuation of U.S. patent application Ser. No. 12/562,301 filed Sep. 18, 2009, which claims priority to U.S.Provisional Patent Application 61/098,244, filed Sep. 19, 2008, the entirety of which are herein incorporated by reference.
FIELD OF THE INVENTION
• The present invention relates generally to the medical technology field and, in particular, to a cryogenic system.
BACKGROUND OF THE INVENTION
• Over a recent number of years, there has been a strong movement within the surgical community toward minimally invasive therapies. The main goals of the minimally invasive therapies include: 1) eradication of targeted tissue, 2) decreased hospitalization time, 3) limited postoperative morbidities, 4) shortened return interval to daily functions and work, and 5) reduced overall treatment cost. Cryotherapy is a minimally invasive method of treating a disease state through tissue freezing with thousands of patients now receiving the procedure annually. Currently, cryotherapy is used to treat numerous disease states including organ confined tumors such as prostate, kidney, liver, as well as cardiovascular disease, retinal detachment, pain management, and other illness/disease states.
• Cryotherapy is an effective yet minimally invasive alternative to radical surgery and radiation therapy. The procedure is done under either general or epidural anesthesia. The procedure offers patients a quicker recovery and reduced severity of potential side effects. Without the expense associated with major surgery or an extended hospital stay, cryotherapy is a cost-effective treatment option.
• The approaches utilized to date have focused on the delivery of liquid cryogen through the use of moderate to high pressure on the entire system or piston/bellows compression to drive fluid movement. At present, current systems utilizing liquid nitrogen operate at pressures between 14-480 psi; the systems in use cannot operate or withstand pressures greater that 500 psi. Further, the use of heat exchangers have been limited to coils placed into a bath of cryogen to allow for time consuming, inefficient passive subcooling of the cryogen in which activation of these devices circulate a cryogen (such as liquid nitrogen) to a probe to create a heat sink, thus resulting in tissue freezing.
• There exists a need for improvements in cryotherapy, and medical devices or components associated with the treatment, to better circulate liquid cryogen to a cryoprobe, to provide for rapid delivery through small tubes, and to facilitate improved measures for treatment and cost. The system of the present invention will allow for the circulation (cooling, delivery, and return) of liquid cryogen to a cryoprobe for the freezing of targeted tissue. The invention will facilitate the eradication of tissue, decrease hospitalization time, limit postoperative morbidities, shorten return to daily functions and work, and further reduce the overall treatment cost. Desirably, these improvements to device design and application will also increase its utilization for the treatment of multiple disease states.
SUMMARY OF THE INVENTION
• The following invention is a cryogenic medical device designed to deliver subcooled liquid cryogen to various configurations of cryoprobes for the treatment of damaged, diseased, cancerous or other unwanted tissues. The device is a closed or semi-closed system in which the liquid cryogen is contained in both the supply and return stages.
• By converting liquid nitrogen to supercritical nitrogen (SCN) in a cylinder/cartridge cooled by atmospheric liquid nitrogen (−1960 C.), the SCN can be subcooled and tuned to the liquid phase, attaining an excess temperature. When the SCN is injected into one or more flexible cryoprobes, the SCN flows with minimal friction to the tip of the probe. In the tip, SCN pressure drops due to an increased volume and outflow restriction, heat is absorbed (nucleate boiling) along the inner surface of the tip, micro bubbles of nitrogen gas condense back into a liquid, and the warmed SCN reverts to pressurized liquid nitrogen as it exits the return tube and resupplies the dewar containing atmospheric liquid nitrogen. This flow dynamic occurs within a few seconds, typically in the order of 1 to 10 seconds depending on the probe or attachment configuration, and is regulated by a high pressure solenoid valve. Further, once the instruments are in place, the cryosurgical procedure can be performed with freeze times in ranges of about 15 seconds to 5 minutes (or ranges thereof), a drastic improvement over current known methods. Upon emptying of the first cartridge subassembly, the process can be repeated with the second cartridge subassembly or any number of cartridges operated individually or in combination. Furthermore, embodiments of the present invention can be incorporated in any supercooling system or in delivering liquid cryogen to the desired instrument.
• In one embodiment, the closed or semi-closed system has multiple pressurized cylinders filling and firing in sequence, and pressurized through a heating coil in one or more of the contained pressurized cylinders. The device is vented to the surrounding atmosphere through an adjustable pressure vent to prevent excess pressure buildup while in operation. The device comprises a number of parts including a vacuum insulated outer dewar, submersible cryogen pump, a series of self -pressurizing pulsatile delivery chambers, baffled linear heat exchanger, return chamber, and a series of valves to control the flow of the liquid cryogen. The outer dewar comprises a cryogenic apparatus having pressurizing pulsatile delivery chambers which drive liquid cryogen through the baffled linear heat exchanger. The linear heat exchanger comprises a tube-within-a-tube (i.e. chamber within a chamber configuration) whereby a vacuum is applied to the outer chamber to subcool an isolated reservoir of liquid cryogen. The inner chamber comprises a series of baffles and a central spiral to increase the flow path of the liquid cryogen while providing for increased contact-based surface area with the outer chamber to allow for more effective heat transfer and subcooling of the cryogen being delivered to the probe.
• Following circulation to the cryoprobe, cryogen (liquid and gas) is returned to the device into a return chamber which surrounds the supply chamber, thereby providing for a staged secondary subcooling chamber for the cryogen in the supply tube. The return chamber is open to the main dewar tank thereby allowing for exchange of liquid and gas between the supply and return chambers. Device operation is controlled and monitored by a series of pressure and vacuum valves designed to control the flow, cooling, and pressurization of the liquid cryogen. This control is achieved through various configurations of manual and computer controlled systems.
• In one embodiment of the invention, a cryogenic catheter or probe designed to deliver cryogen (liquid or gas) for the treatment of damaged, diseased, cancerous or other unwanted tissues is disclosed. The product/device is a tube within a tube and comprises a number of parts including a supply and return tubes (i.e. internal tubes), outer sheath (i.e. external tube) sealed to the inner tubes at one or both ends with a gas filled lumen between the internal and external tubes. The lumen of the external tube is filled with a non-equilibrating saturated gas which solidifies upon cooling, thereby creating a vacuum along the length of the catheter to provide for insulation between the inner and outer tubes and preventing freezing along the length of the probe shaft. Further the outside surface of the internal tubes is modified to potentiate gas nucleation on the outer surface of the internal tubes upon cooling.
• At the distal end or tip of the probe shaft, the internal tubes come into contact with the outer tube and create a defined region of ultra cold temperatures to cool and freeze the target tissue region. The catheter is designed to carry liquid cryogen under various pressures as well as liquid cryogens of varying temperatures. Delivery of cryogen to the catheter is provided by a cryogenic medical device console through the connection of the longitudinal body.
• In one embodiment, a dual insulative barrier is capable of being formed. The device creates a temperature initiated transient vacuum insulation along the length of a catheter. The device further couples the temperature initiated vacuum with that of a surface modification along the inner tubes/lines to enhance nucleation and deposition of the saturated gas on the outer surface of the inner tubes to create an additional layer of insulation. The enhanced deposition or nucleation modification contributes by making the vacuum more effective. In addition, the saturated gas filled lumen of the outer tube at ambient temperature may be run at any given pressure. For exemplary purposes and not limitation, one embodiment maintains the pressure at atmospheric levels or may control the pressure to elevated or reduced levels.
BRIEF DESCRIPTION OF THE DRAWINGS
• The invention is best understood from the following detailed description when read with the accompanying drawing figures. It is emphasized that the various features are not necessarily drawn to scale. In fact, the dimensions may be arbitrarily increased or decreased for clarity of discussion. Further, the below representations of a longitudinal body may not be drawn to scale where particular aspects extend the longitudinal body to lengths up to six feet and beyond (as dependent on the desired application).
• FIG. 1 is a side view of an illustrative embodiment of the device of the present invention.
• FIG. 2 is a side view of one embodiment of a heat exchanger of the present invention.
• FIG. 3 illustrates a side view of one embodiment of a heat exchanger of the present invention.
• FIG. 4 is a top view of one embodiment of a device of the invention.
• FIG. 5 is a depiction of a front view of the system.
• FIG. 6 is a side view of an illustrative embodiment of the device of the disclosed invention when the lumen is filled with particles in gaseous state.
• FIG. 7 is a cross-sectional view of the illustrative embodiment inFIG. 6.
• FIG. 8 is a side view of an illustrative embodiment of the device of the disclosed invention as temperatures are reduced to a freezing point of the particular gas selected.
• FIG. 9 is a cross-sectional view of the illustrative embodiment inFIG. 8.
• FIGS. 10-13 are side views of various embodiments of a device of the invention.
• FIG. 14 is an illustrative embodiment of a product of the present invention.
DETAILED DESCRIPTION
• In the following detailed description, for purposes of explanation and not limitation, exemplary embodiments disclosing specific details are set forth in order to provide a thorough understanding of the present invention. However, it will be apparent to one having ordinary skill in the art that the present invention may be practiced in other embodiments that depart from the specific details disclosed herein. In other instances, detailed descriptions of well-known devices and methods may be omitted so as not to obscure the description of the present invention.
• An external view of a device and system in accordance with one embodiment of the present invention is shown inFIG. 1. The cryogenic system ordevice30 has sidewalls17 which form acontainer6 that encloses an internal cavity, orlumen15. In an embodiment ofFIG. 1, thecontainer6 takes the form of a vacuum insulateddewar6. Thedewar6 stores liquid cryogen and interconnects asupply line11 and returnline12 to a probe or catheter (not shown) to form aclosed system30. Thedewar6 may be made of material such as stainless steel or any other material known for providing a vacuum insulated vessel. Thedewar6 is filled with liquid nitrogen or other liquefied gas (here, discussing as cryogen) to amaximum level13. In one aspect, liquid nitrogen may be preferred. In another aspect, any fluidic cryogen may be utilized (e.g. argon, oxygen, helium, hydrogen).
• Within theinternal cavity15 of thedewar6 is asubmersible pump1 which delivers the liquid cryogen to a sealedpressurization apparatus40. In one embodiment, a valve2 controls the pressure fill into internalopen chamber42 of thepressurization apparatus40. Once the cryogen enters thepressurization apparatus40, animmersion heater44 housed in the internalopen chamber42 heats the cryogen to create a desired pressure. The liquid nitrogen within the pressurized chamber starts at a temperature of about −196° C. When the heater is activated, it boils the nitrogen within the immediate area. Temperature withininternal cavity42 therefore stays within about −196 0 C. to −150 0 C., more typically in the range of about −196 0 C. to −160 0 C., or rather between about −170 0 C. to −1600 C. Pressurized cryogen is then released through avalve32 into the baffledlinear heat exchanger4. In one aspect, liquid nitrogen is converted to supercritical nitrogen (SCN) within the pressurization apparatus. The SCN is then directed to the heat exchanger for subcooling and tuned to the liquid phase to attain an excess temperature. Thereafter, the SCN can be injected into one or more flexible cryoprobes such that the SCN flows with minimal friction to the tip of the probe.
• The baffledlinear heat exchanger4 in one embodiment is surrounded by asubcooling chamber3 which subcools the pressurized cryogen for delivery to external cryoprobes. Thesubcooling chamber3 in connection with theheat exchanger4 at anentrance23 and anexit opening36 form anintegral unit51 for supplying subcooled liquid cryogen. From theheat exchanger4, the subcooled cryogen passes into asupply line11 and continues out through anexit port35 and through acontrol valve14 where various configurations of cryoprobes are attached. The subcooling chamber may attach a vent line to any of thevents8, to asupply connecting line19 controlled through avalve27, or to avacuum line16 through acontrol valve7 which is connected to a vacuum pump18.
• The cryogen is returned (as demonstrated by the arrows inFIG. 1) from the cryoprobe via areturn tube12 into a return chamber/cylinder5 of thedewar6. Thereturn tube12 connects into the return cylinder5 which also surrounds thesupply tube11 that exits theheat exchanger4. One ormore exit ports35 may be included in a side wall17 of thedewar6 or may be aseparate unit14 to incorporate various control valves.
• In operation, thedevice30 is filled through asupply port29 and then sealed to form a closed system, thereby allowing for the supply, return, collection, and re-utilization of liquid cryogen during its utilization in the medical/surgical field. Theentire system30 may or may not be pressurized during operation. The system may also be vented to the surrounding environment to prevent excess pressure buildup during operation. In one aspect, the returning cryogen empties into the return cylinder or chamber5. In another aspect, the returning cryogen may empty as bulk fluid into theinternal lumen15 within thedewar6.
• In one embodiment of the present invention, thelinear heat exchanger4 subcools the liquid cryogen prior to delivery to tissue. In the embodiment ofFIG. 1, thelinear heat exchanger4 is aninner chamber4 which passes throughsubcooling chamber3 and is connected via theentrance23 andexit opening36. Liquid cryogen passing through theinner chamber4 is reduced in temperature to a subcooling degree by theouter subcooling chamber3. The chamber within a chamber configuration includes asubcooling vacuum chamber3 filled with liquid cryogen upon which a vacuum18 is drawn through valve-controlled port9 to reduce the atmospheric pressure on the cryogen. The temperature of the cryogen within thesubcooling chamber3 can then be reduced even further. Thesubcooling chamber3 also comprises valve controlledports8 external to the maximum liquid cryogen level for monitoring and electronically controlling temperatures, pressures, and flow rates of liquid cryogen passing through the subcooling unit. In one aspect, a vacuum18 can be drawn onvacuum line16 at a controlledinternal valve7 or external valve9. In another aspect, valve controlledports8 may be accessible for delivery of liquid cryogen to thesubcooling chamber3 by way of asupply line19 or as avent8 for any excessive gas coming from thesubcooling chamber3. As depicted inFIG. 1, the vacuum18 also is attached to the cryoprobe(s) by way ofvacuum line39.
• Aspects of thelinear heat exchanger4 are illustrated inFIGS. 2 and 3.FIG. 2 andFIG. 3 illustrate side views of different aspects of a linearbaffled heat exchanger4 andsubcooling unit3 as anintegral unit51. An interior central component or spiral20 within the interior lumen of thechamber4 operates like a corkscrew to increase theflow path25 of the liquid cryogen. Anouter wall22 of theinner chamber4 also comprisesbaffles24 which increase the surface area in the heat exchanger for quicker and reduced cooling of the liquid cryogen. As illustrated, a series ofbaffles24 emanate into the flow path25 (as illustrated by arrows) of the cryogen in the inner lumen, thereby increasing the surface area in theheat exchanger4. The spiral component, however, may be any size and shape as to efficiently increase the flow of liquid cryogen. Planar structures, as described below, or any additional features included to increase surface area may be incorporated or substituted.
• FIG. 3 illustrates another embodiment of alinear heat exchanger4 such that theinternal structure20 has a planar configuration and also operates in a circular motion to increase theflow25 of the liquid cryogen. Aninternal structure20 assists in circulating the flow of liquid cryogen through the interior lumen of thechamber4, possibly with an interconnected tubular unit that would allow radial movement ofinternal structure20.
• One embodiment of the medical device comprises a return chamber5 which is illustrated as a return cylinder5 inFIG. 1 such that the return chamber5 surrounds thesupply line11 coming from theheat exchanger4. The return chamber5 and the surrounded supply line may then provide a secondary heat exchanger for the system/medical device30. Cryogen return is vented into the return chamber5. In one aspect, the return chamber5 comprises a series of vent holes26 near the top of the return chamber5 to allow for the venting of gas and/or liquid overflow into themain dewar6. Vent holes26 allow for the reutilization of cryogen and thus extend the operation time for themedical device30.
• In another aspect, thereturn tube12 is vented into themain dewar6 either directly or by first passing through a linear heat exchanger (similar to the combination ofheat exchanger4 and subcooling chamber3) to subcool the return cryogen prior to venting into themain dewar6. Return of the cryogen to themain dewar6 allows the cryogen to return through a heat exchanger such that the cryogen is reutilized and extends the operation time even longer.
• In another embodiment, themedical device30 may provide a system which is controlled through a series of computer controlled valves including any heaters, sensors, motors, or gauges. The sensors control and monitor pressure, temperature, and fluid level in the dewar, and can measure any metric as may be desired. In one aspect, the sensors monitor pressure levels within defined safety ranges. In another aspect, the sensors may control the pressurization of one or more components internal to the dewar. Any of thevalves2,7,8,9,27 or32 including exitportal valve14, maybe automated to enable a controlled and consistent operation of the cryogenic system (e.g. computer controlled operation through the electronically controlled valves).
• An embodiment of asystem50 is shown inFIG. 4. As illustrated in a top view of thesystem50, a series of sixpulsatile pressurization chambers40 are sealed chambers/cylinders40 withindewar6 of theclosed system50. From the pump, liquid cryogen in pumped to thepulsatile pressurization chambers40 which then delivers liquid cryogen in a continuous series of bursts to theheat exchanger4. The baffledlinear heat exchanger4 provides an enhanced subcooling of the pressurized liquid cryogen while also incorporating anintegral subcooling unit3. Thechambers40, each comprising anindividual immersion heater44, can then sequentially deliver liquid cryogen at consistent rates, or as specifically determined rates, to theheat exchanger4.
• From the heat exchanger, the subcooled cryogen passes into asupply line11 and continues out through anexit port35 where acontrol valve14 is positioned and various configurations of cryoprobes are attached. The cryogen is returned (as demonstrated by the arrows inFIG. 4) via areturn tube12 from the cryoprobe to thedewar6 into a return cylinder5. Thereturn tube12 connects into the return cylinder which surrounds thesupply tube11 that exits theheat exchanger4. Theentire system50 may or may not be pressurized during operation. The device is also vented throughvent ports8 to the surrounding environment to prevent excess pressure buildup during operation.
• During the operation of thesystem50, as illustrated in the embodiment ofFIG. 4, acryogenic system50 has been filled and detached from its cryogenic fill tank. In one embodiment, thesystem50 is a separate mobile unit protected and contained entirely within an enclosed console for easy access and mobility. Once the system has been sealed, the cryogenic supply can be maintained for several procedures. The reutilization of the liquid cryogen provides a time savings and cost-efficient model for cryotherapeutic and cryosurgical procedures. Thesystem50 can be further utilized for any process requiring rapid cooling.
• As depicted, thesystem50 comprises a submersibleliquid nitrogen pump1 connected to asupply line11 which directs the liquid nitrogen into asupply manifold33. Thesupply manifold33 routes the liquid nitrogen into at least onepulsatile pressurization chamber40 where the liquid cryogen is heated. The pressurized liquid cryogen, here, liquid nitrogen, then starts filling the next pressurization cylinder/chamber40 in the series such that when onechamber40 is filling, another can be simultaneously pressurized and prepared for use. This permits a wave of activity through the cylinders so that it can cycle through each step of system operation. As the pressurized cryogen is delivered to theheat exchanger4, and passes the subcooled pressurized cryogen out through thesupply line11 through theexit port35 and into the attached cryoprobes, another pressurization chamber is filled and pressurized. The simultaneous use and pressurization of the liquid cryogen provides for the sequential delivery of liquid cryogen in a continuous series of pulsations to a cryogenic instrument or probe.
• In one embodiment, liquid nitrogen is used; however, any cryogenic fluid may be utilized, including nitrogen, argon, helium, hydrogen, and other such desired fluids. Eachpressurization apparatus40 comprises a pressure valve controlledinlet52, valve controlledoutlet54, and vent ports as may be desired, as well as animmersion heater44. In one aspect, the filling of thepressurization apparatus40 is controlled through a series ofpressure valves52 on thesupply manifold33. Liquid cryogen is heated within each pressurized apparatus. Pressurized liquid cryogen is then released through thecontrol valve54 to an outlet port/opening46 of anoutlet manifold34 to thesupply line11, and delivered to a baffledlinear heat exchanger4. In the illustrated embodiment, asubcooling unit3 surrounds theheat exchanger4 for more rapid cooling.
• In one embodiment, thecryogenic device50 comprises sixpressurized apparati40 linked together. Other embodiments, however, may comprise any number ofpressurized apparati40 individually or linked together in combination. The apparati can then be controlled individually or in sequence to deliver pressurized liquid cryogen to theheat exchanger4. In another aspect, one or more pressurization apparati40 may be arranged to supply one or more cryoprobes. Further, the series ofpressurized apparati40 may be interconnected with another series ofapparati40.
• In the embodiment ofFIG. 4, sixpulsatile pressurization chambers40 are housed within a support network of a console. In one example, three of the cylinders within one-half of the dewar simultaneously fill while three cylinders within the other half of the dewar deliver cryogen out through the outlet manifold. (Any number of cylinders, however, may be operated individually or in desirable combinations.) Liquid cryogen is heated in the sealedpressurization chambers40. Pressure is increased to a specified level in the sealedpressurization chambers40, and then the pressurized cryogen is controllably released into aheat exchanger4 to subcool the cryogen. In one aspect, asubcooling vacuum chamber3 surrounds theheat exchanger4, facilitating the delivery of subcooled cryogen to an attached cryoprobe (also referred to as probe or catheter). As the pressurized cryogen is utilized, a sensor within the heat exchanger monitors the temperature and pressure of the subcooled cryogen passing intosupply line11 as it continues out through anexit port35 where various configurations of cryoprobes are attached.
• Although the system may fill or discharge eachcylinder40 individually, any simultaneous fill or discharge, or rate of fill or discharge, may be incorporated into the system. The closed system keeps a constant supply of liquid nitrogen available for delivery to the cryoprobe and provides a more immediate and rapid rate of cooling for cryotherapeutic procedures. It is therefore possible to close thesupply port29 where supply tanks fill the dewar (SeeFIG. 1 andFIG. 4) and move the system to any locale or setting. Furthermore, as depicted inFIG. 1, the supply valve2 may be closed and therelease valve14 opened to create a flow of liquid cryogen to the cryoprobe. Various arrangements of valves and sensors may therefore provide for similar flow.
• In one embodiment, thepressurized chambers40 are filled and the dewar sealed. Asingle drive pump1 perpetuates directional flow of the cryogen into the pressurization chambers. In one embodiment, all chambers can be filled through various configurations of single direction pumping. In another embodiment, a reversible pump and fill method allows onepressurized chamber40 to fill and then thepump1 flips or reverses functionality to fill another pressurized chamber. This process can be repeated to fill any number of chambers.
• In one embodiment,pressurized chambers40 are enclosed completely within thedewar6. However, any arrangement of the pressurized cylinders is possible so long as the closed system provides for the pulsatile delivery of cryogen to the cryoprobe. As such, any single or multiple configurations of cryoprobes or catheters may be used. Such instruments may also include cryoguns or cryodevices for rapid cryo-delivery processes or cryotherapies.
• As illustrated inFIG. 5, a cryogenic system200 (also known as cryoengine200) has a two cylinder configuration, the system of which is divided into two subassemblies: (I) those components above the cover209 and (II) those components below the cover. All of the components below the cover are contained in aliquid nitrogen dewar206 and immersed in liquid nitrogen at atmospheric pressure (BP=−196° C.) during operation. The machinery and components of the operational system are housed in aconsole210 to which the cryocatheters/cryoprobes265 are attached to form thecomplete system200. To understand the operational features of the cryoengine and method of production and transport of supercritical nitrogen (SCN), a brief description of cryogen flow follows.
• Upon filling thedewar206 with liquid nitrogen from an external source, an immersibleliquid cryogen pump201 is activated to fill eachcryogen supply cylinder202a&202b,or cartridge, sequentially. Initially, onecartridge202ais filled along with its linkedcryogen pressurization cartridge203a.Cryogenic solenoid valves204 (a and b) provide venting of the gas within the cartridge assembly to support filling. Manifolds208 (typically metal, stainless steel or aluminum) provide access points into the cartridges/cylinders202,203. The manifolds comprise components such as a heater, thermocouple, and the vent lines that pass through to the cylinders202,203. Upon completion of the filling process, thecryogen pressurization cartridge203ais heated to generate a pressure of about 1000 psi (68 bar). Liquid nitrogen becomes critical at about 493 psi (34 bar) (BP=−147° C.). Pressurization beyond the critical point results in the formation of SCN, a dense fluid without surface tension and capable of frictionless flow, and with properties that may be tuned to either a gas or liquid.
• By converting liquid nitrogen to SCN in a cartridge cooled by atmospheric liquid nitrogen (−1960 C.), the SCN is subcooled and tuned to the liquid phase, attaining an excess temperature (i.e. the ability to absorb heat without boiling) of approximately 500 C. When the SCN is injected into the flexible cryoprobe, the SCN flows with minimal friction to the tip of the probe (boiling chamber). In the tip, SCN pressure drops due to an increased volume and outflow restriction, heat is absorbed (nucleate boiling) along the inner surface of the TIP, micro bubbles of nitrogen gas condense back into a liquid, and the warmed SCN reverts to pressurized liquid nitrogen as it exits the return tube and resupplies the dewar containing atmospheric liquid nitrogen. This flow dynamic occurs within a few seconds and is regulated by a high pressure solenoid valve204. Upon emptying of the first cartridge subassembly (202a&203a), the process is repeated with the second cartridge subassembly (202b&203b).
• As demonstrated byFIG. 5, the limitations of liquid nitrogen have been overcome by developing a novel device to convert atmospheric liquid nitrogen to supercritical nitrogen. Where liquid nitrogen was previously delivered through large tubes and did not provide for rapid delivery, the current system herein described allows for rapid delivery of liquid cryogens through very small tubing of the cryo-instrument265. The SCN can be injected or drawn through two plus meters of hypodermic tubing without boiling, thereby resulting in near instantaneous ice formation at the tip to target site specific ablation of tissue as well as the creation of transmural lesions without the formation of a thrombus or aneurysm. Supercritical nitrogen is a dense fluid with properties of both gas and liquid that can be tuned toward one phase or the other. In the liquid phase, SCN lacks surface tension and transports without friction. The above-described technology generates SCN in a pressurized cartridge immersed in atmospheric liquid nitrogen. This cryoengine, which operates as a cryogen generator, produces SCN in the liquid phase with a boiling point of about −1490 C. which is subcooled by the surrounding atmospheric liquid nitrogen to about −196° C. When the SCN is expelled from the device to the probe tip, the SCN passes instantly through the system without the phase transition to a gas due to both the frictionless flow and the subcooling which compensates for parasitic heat gain along the path. As such, the embodiment ofFIG. 5 may be utilized in any supercooling system or in directing flow of liquid cryogen through to a cryo-instrument. The supercritical point will be determined by the chemistry of the specified liquid or gas used. Therefore, the system can be adjusted to accommodate for differences in chemistry. A catheter/probe assembly265 is connected to the cryoengine ofFIG. 5.
• An external view of adevice65 in accordance with one embodiment of the present invention is shown inFIG. 6 andFIG. 7. Thedevice65 of an embodiment takes the form of a catheter having a tube within a tube configuration, and forming thelongitudinal body65. Thelongitudinal body65 comprises internal tubes, including asupply line62 and areturn line63, contained within anouter insulation tube61 and continuously running through the length of thetubular shaft60 of thelongitudinal body65. Theouter insulation tube61, orouter catheter sheath61, defines the size, shape, and dimensions of thelongitudinal body65 which conforms to dimensions that are capable of housing theinternal lines62,63. The tubular shaft therefore extends from aproximal end51 of thelongitudinal body65 to a distal end ortip68. Theouter catheter sheath61 provides a unitary support structure for the flow of cryogen to and from the distal end of thecatheter tip68; desirably, the distal end is where a freezing event is initiated. The cryogen utilized in one embodiment may be liquid nitrogen. In another embodiment, supercritical nitrogen is utilized. Any desired liquid cryogen may be utilized, however, and the system adjusted to accommodate for different chemistries and phases of matter.
• Theinner supply line62 and returnline63 are maintained in the center of theouter sheath61 by openconfiguration insulative spacers53 placed throughout thecatheter65. The open configuration allows for acatheter lumen64 to be filled with gas. Theouter catheter sheath61 is sealed to theconnector66 to create thegaseous lumen64. Thetip68, in combination with theinner supply line62 and thereturn line63 come into contact with theouter sheath61 at the distal end to develop a freezing region.
• In addition, in one embodiment, theshaft60 of thecatheter65 is flexible, as facilitated by adeflection wire67 that runs along theshaft60, the shaft of which is insulated by a temperature induced vacuum. Thedeflection wire67 is a control line that runs down theshaft60 to the tip of thecatheter65 to allow thecatheter tip68 to be moved on an angle, in a finger-like motion to steer and direct the catheter/probe65 to the target tissue. In one embodiment, thedeflection wire67 guides thedevice65 and monitors environmental measures of temperature, pressure, and/or physiological conditions. Theguide67 may integrate individual components and sensors such as an optical imaging component in connection with the guide or any number of thermocouples, pressure transducers, electrocardiogram monitors, or other electrophysiological sensors, alone or in combination.
• Another embodiment of the present invention may use insulative foam (e.g. styrofoam, plastics, rubberized materials or other such insulative compositions) to separate theouter shaft60 from theinternal lines62,63 (i.e.inner supply line62 and return line63). Various aspects of the invention, however, accommodate acatheter tip68 as designed to be steerable and deflectable to allow for guided targeting to the desired tissue site. In one aspect, spacers or insulative foam may be utilized to prevent internal supply and return lines from contacting the outer sheath. In another aspect, any freeze zone can be produced as designated by the configurations ofcatheter tips68. (SeeFIGS. 10-13).
• In the process of utilizing thecatheter65 of the present invention, a condensation based vacuum insulation is temperature dependent and located in thecatheter65. Upon theouter surfaces69 of the walls of thesupply line62 and returnline63, a process of physically marking or chemically etching thesurfaces69 enhances nucleation and physical vaporization deposition of saturated gas. For exemplary purposes only and not limitation, the surface may be roughened, sprayed with any number of powder-like substances like silica, metallic particles and/or a carbon coating. Thelumen64 within theouter sheath61 is filled with select vapors, or non-equilibratedphase change gas64. In this embodiment, for example, butane is utilized which remains in a gaseous state at about room temperature, between about 00 C. to about 37° C. (SeeFIGS. 6, 7), but solidifies intocrystalline deposits52 upon chilling to below about 00 C., and simultaneously deposits a film of crystals in a controlled deposition process upon the designated surfaces69 (SeeFIGS. 8, 9). It should be noted, however, that the temperature variations are dependent upon the type of vapors utilized, chemical characteristics and variations of vapor combinations. Therefore, temperatures of varying gases may be selectively controlled so as to create the same or similar effect of spontaneous nucleation and simultaneous deposition upon reaching a freezing temperature.
• In addition, one embodiment may interconnect a vacuum line of a cryosystem console with the catheter or probe65 through avacuum port55 of theconnector66 as illustrated inFIGS. 6 and 7. In one aspect, the vacuum is formed upon sealing the lumen at the connector and mechanically drawing a vacuum throughvacuum port55. In another aspect, the vacuum port may connect via its own vacuum system or in combination with the vacuum pump of the cryosystem. Thus, a dual insulative barrier can be created in the present invention by either a mechanically drawn vacuum or a spontaneously induced vacuum [via temperature inducement] (the vacuum itself creating the insulation for the internal tubes) in combination with a nucleation enhanced surface modification to enhance deposition of gas crystals onto the designated outer surfaces of the internal tubes. Desirably, the outer walls of the internal tubes are physically or chemically etched at designated sites along the tubular shaft. A region within the distal end ortip8 can then be configured specifically designated freeze zones.
• In the described embodiments, nucleation/sublimation in combination with a deposition process forms solid crystals along thesupply line62 and returnline63 outer walls, and spontaneously results in an evacuated space within thelumen64. The evacuated space acts as an insulative barrier between the outer catheter sheath and the frost encasedinner lines62,63. Film wise deposition along a length of thesurfaces69 of thesupply line62 and returnline63 results in crystalline film deposits of low thermal conductivity. The deposition may coat a portion of the outer surfaces or the entire outer surfaces of the inner lines to run the entire length of the internal tubes. (Note: The V marks inFIGS. 6, 7 demonstrate the nucleation enriched supply and returntubular surfaces69, the tubular surfaces of which are modified by processes described herein. Thenon-solidified gas crystals54, non-equilibrating phasechange gas particles54, are illustrated inFIG. 7. Nucleated or solidified particles, as designated by “*” are depicted inFIGS. 8, 9 upon the modifications “x” (etching) on thesurfaces69. The nucleated particles52 (marked as “*”) are formed when the gas reaches a freezing temperature. In one aspect, any pressure may be utilized. For exemplary purposes and not limitation, pressure in the device may be maintained or controllably elevated or reduced. For instance, gas may be maintained at atmospheric or high pressure to support the retention of the vapor state at room temperature.
• Other aspects of embodiments of the present invention include gas as either a pure component or as a mixture of various components. Such gaseous compositions, for exemplary purposes only and not limitation, may comprise butane, carbon dioxide, iodine, camphor, and/or nitrous oxide.
• In another embodiment, anenhanced nucleation surface69 on inner tube/line62,63 surfaces may result where a process includes treating the walls of theinner lines62,63 to match nucleating efficiency with the chemical characteristics of the gas to be deposited (e.g. marking the surfaces with impurities, utilizing silica, or other powderized material, chemically coating or etching) and thereby create a similar effect.
• Embodiments of the present invention manipulate the structural configurations of thetips68, as illustrated inFIGS. 10-13. In one or more embodiments depicted, the freeze zone is created where theinternal components62/63 contact theouter sheath61 at adistal end68. One such embodiment of adistal end100 inFIG. 10 includes a closed loopcoiled supply tube106 in contact with theouter sheath61 to affect a cold sink. Thesupply line62 and returnline63 convene at the freezing zone of the tip in the formation of acoil106.
• In another embodiment of adistal end110, as shown inFIG. 11, ametallic balloon tip107 is illustrated in which cryogen is circulated in the tip and then returned. Thesupply line62 extends to a distance into thetip68 beyond the extension ofreturn line63 such that cryogen pumped into the balloon-like tip107 circulates within the sealed confines of the inflated region when the catheter is engaged for the procedure. Thesupply line62, however, can extend any length or distance into the tip. The balloon-like tip may be composed of any flexible or rigid material including metallic, plastic, or ceramic compositions. Similarly, the balloon-like structure within the sheath may cause theouter sheath61 to inflate and deflate for cryogenic procedures.
• For example, and not limitation, cryogenic procedures performed within a vessel may advantageously make use of an inflatablecryogenic element107 at the distal end of the probe so that the outer sheath expands as the internal inflatable cryogenic element expands.
• Also depicted inFIG. 11, theinflatable tip107 is a sealed within thedistal portion68 in connection with both anindividual supply line62 and anindividual return line63. The embodiment of thedistal end110 is included in the length of the longitudinal tube and has adistal tip68 which serves as the freezing region in connection with the tubular shaft60 (only a portion of which is illustrated here inFIG. 11) (i.e. In the embodiment shown inFIG. 14, adistal end128 can be replaced withdistal end110.) A sealedinterface127 ensures that the inflatable area can expand and contract in correspondence with the fill and removal of the cryogenic medium. The cryogenic medium in one embodiment in liquid nitrogen. Any cryogen may be utilized, however, to accommodate the demands of the system and treatment measures. Further, the inflatable structure, here, a metallic balloon tip, is designed and configured with materials that conform to the use of liquid nitrogen. Without considering the type of cryogen utilized, the inflatable tip may rupture or create undesired effects. For exemplary purposes, and not limitation, the tip of the present embodiment is designed to meet the needs of a system and device utilizing liquid nitrogen.
• Another aspect of the probe/system inFIG. 11 is that the sealedinterface127 may be a wall or connection component (not illustrated) which seals the freezingregion68 of the tip away from thetubular shaft60 in a blunt-tip probe. The sealed interface allows asupply line62 and areturn line63 to access the freezing tip, the open ends137 of which allow cryogen to be dispersed within the sealedzone68. InFIG. 11, the sealed zone is the balloon tip, but any size or shape of sealed zone may be utilized in different aspects of the present invention to create similar results. It should be noted that the open-ended supply line in one embodiment extends further into the sealed zone toward the distal end and beyond the open end of the return line. Any length of supply line or return line, however, may be utilized; the lengths may be designed having equal lengths or different lengths, as desired.
• FIG. 12 is another embodiment of the probe tip/distal end155 which illustrates aclosed loop tip118. The closed loop tip integrally connects bothsupply line62 and returnline63 to form a unitary structure for delivery and return of liquid cryogen to the distal end in the freezing region of the probe.
• FIG. 13 illustrates acryoprobe165 as a closed loop tip with afinned heat exchanger119 within the freezing zone ortip68. The heat exchanger provides for a more efficient heat extraction from the tissue, thereby providing faster cryotreatment and greater injury/freezing to the tissue site. The heat exchanger is also utilized to cool the cryogen prior to return to the console, resulting in increased cryogen recovery. Other variations in tip design may be any size and dimension or take the size or shape of known catheters or probes65 in the field. For exemplary purposes and not limitation, in cancer therapeutics, cryoprobes are utilized to ablate the target tissue. In cardiac applications, catheters or surgical probes are utilized in the cryoablation procedure. Further configurations of the cryoprobe as described infra may also accommodate other structural variations.
• As demonstrated inFIG. 14, the product for performing cryotherapeutic procedures is illustrated as anelongated body175, about six feet in length. Aconnector116 at aproximal end121 allows the cryoprobe to be connected with a cryogenic delivery system200 (seeFIG. 5). The freezing region, ortip138 is position within thedistal end128 with a flexibletubular shaft120 positioned between the ends. (Some of the various embodiments ofdistal end128 have been depicted inFIGS. 10-13, embodiments ofdistal ends100,110,155,165 which can serve as replacements for thedistal end128 within theelongated product175. Thesupport structure175 comprises an outer sheath (as illustrated inFIGS. 6 and 7) which has at least one internal tube configured inside the sheath to deliver and return liquid cryogen to and from the freezing region/zone at the target tissue site. When in use and hooked to a cryogenic delivery system, theproduct175 simultaneously produces an insulative vacuum throughout thetubular shaft120. A dual insulative barrier is formed by a temperature initiated transient vacuum in combination with an enhanced nucleation deposition process along the outer surface of the internal tubes (discussed infra). The nucleation sites are therefore capable of selective placement anywhere throughout the product.
• In one embodiment, thedistal end128 is a needle-like probe end. In another embodiment, thedistal end128 takes the form of a blunt-tip probe end. Thedistal portion128 may be integral with the tubular shaft or be removably placed in connection therewith. The interconnections of proximal connector, tubular shaft, and distal probe ends thus determines whether or not the individual parts, alone or in combination, may be reused, or disposed of. Further, the length of the distal end28 may vary according to treatment procedure and may be any size, shape and dimension to correspond to the tissue treated.
• The invention facilitates other improvements in cryotherapy, and medical devices or components associated with the treatment. The medical device of the invention allows for the circulation (cooling, delivery, and return) of liquid cryogen to a cryoprobe for the freezing of targeted tissue. The invention facilitates the eradication of tissue and can thereby decrease hospitalization time; further advantages reduce postoperative morbidities, shorten return to daily functions and work, and further lessen the overall treatment cost. These improvements to device design and application can also increase utilization of the device for the treatment of multiple disease states.
• The device of the invention represents an approach in the development of cryosurgical devices by allowing for temperature induced transient vacuum insulation along the shaft of a cryoprobe or catheter; including insulating the shaft of a cryoprobe or catheter and delivery of cryogen in targeted thermal therapy. Furthermore, the device has been developed to couple the temperature initiated vacuum with that of a surface modification along the inner tubes to enable enhanced nucleation and deposition of the saturated gas on the surface of the inner tubes and create an additional layer of insulation. In one aspect, the device of the invention allows for the enhanced deposition on the outer surface of the inner tubes through modification of the tube surface, thereby creating an additional insulation barrier. In another aspect, the saturated gas filled lumen of the outer tube at ambient temperature may be either elevated or at atmospheric pressure.
• The embodiments of the present invention may be modified to take the shape of any device, container, apparatus, or vessel currently used in industry. As disclosed herein, the cryoprobe device in the invention may be of any size, shape, or dimension. The device may be single use disposable or a multi-use/reusable part (and capable of being sterilized between individual patient treatments). In one embodiment, the longitudinal body extends up to about 6-8 feet or more. Any length, however, may be utilized as designed for particular therapies and treatments. Dimensions less than 12 inches, however, may also be better suited where attached tubing, removable, detachable, or disposable parts are integrated in the design. Specifically, cylindrical or alternative structural designs may be utilized in the cryogenic system for improved catheter/probe access to a tissue target. Further, any rearrangement of the tubes/lines in combination with the components of the above system may take many forms and be of any size, shape, or passageway.
• In utilizing the medical device of the present invention, various methods in the industry may be employed in accordance with accepted cryogenic applications. As discussed, the embodiments of the present invention are for exemplary purposes only and not limitation. Advantageously, this device represents an important step in targeted thermal therapies. Various cryosurgical devices and procedures to apply freezing temperatures to a target tissue may be employed for use with the medical device of the present invention. The medical system disclosed herein has been developed to enable and improve some of the approaches used to target or ablate tissue. Furthermore, the medical device can couple controlled pumping of a liquid cryogen through a baffled linear heat exchanger to decrease the overall temperature of the cryogen providing a greater heat capacity of the fluid and thereby resulting in an increased cooling potential in a cryoprobe.
• In one embodiment of the system, the mechanical and electrical mechanisms of the operational device is contained within a console, a shell or enclosure that allows the system to be easily transported. The enclosure may then include any mobile feature such as wheels, handles, and fixtures (or allow placement onto a cart having these features) so that the system can be transported to and from the location of treatment. Such mobility allows the system to be easily moved to and from an operating room or site of therapeutic treatment. It is also noted that the system is readily separable from the cryogen fill tanks and fill lines that initially supply the system with the liquid nitrogen or other such cryogenic fluid at the supply port29 (As shown inFIG. 1). This improved feature eliminates the bulkiness of standard cryogenic medical devices.
• As presented, the multiple embodiments of the present invention offer several improvements over standard medical devices currently used in cryogenic industry. The improved cryogenic medical devices remarkably enhance its utilization for the cooling, delivery and return of a liquid cryogen to a cryoprobe for the freezing of targeted tissue. The present invention provides cost savings and significantly reduced treatment times which further reduce expenditures in the healthcare setting. The previously unforeseen benefits have been realized and conveniently offer advantages for the treatment of multiple disease states. In addition, the improvements enable construction of the device as designed to enable easy handling, storage, and accessibility. Further uses of the system outside of the healthcare setting are foreseeable. Potential uses in the space industry, defense systems or any industry requiring rapid cooling may incorporate the cryogenic system as thus described.
• As exemplified, the device may include any unitary structure, vessel, device or flask with the capacity to integrally incorporate any combination of such structures. The invention being thus described, it would be obvious that the same may be varied in many ways by one of ordinary skill in the art having had the benefit of the present disclosure. Such variations are not regarded as a departure from the spirit and scope of the invention, and such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the following claims and their legal equivalents.

Claims (1)

What is claimed is:

1. A cryogenic system comprising:

at least one cryoprobe having a freeze zone;

a container capable of being filled with a cryogen;

a pressurization apparatus having one or more heaters arranged therein to generate a pressurized cryogen, the pressurization apparatus having at least one port, wherein when the container is filled with the cryogen,

(i) at least a first portion of the pressurization apparatus is positioned in the cryogen and is at a first temperature, and

ii) at least a second portion of the pressurization apparatus is positioned outside the cryogen and is at a second temperature greater than the first temperature;

a pump disposed in the container for delivering cryogen to the at least one port, wherein the pump is positioned in the cryogen when the container is filled with cryogen;

at least one supply line in fluid communication with the at least one cryoprobe; and

at least one return line that returns the cryogen from the at least one cryoprobe to the container.

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