Source: https://patents.google.com/patent/US20050245943
Timestamp: 2018-02-22 03:26:09
Document Index: 781264714

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'application No. 20020032438', 'application No. 20020010460', 'application No. 20020045892', 'application No. 20020045894', 'application No. 20020045894']

US20050245943A1 - Method of controlling the temperature of gasses passing through a Joule-Thomson orifice - Google Patents
Method of controlling the temperature of gasses passing through a Joule-Thomson orifice
US20050245943A1
US20050245943A1 US11097306 US9730605A US2005245943A1 US 20050245943 A1 US20050245943 A1 US 20050245943A1 US 11097306 US11097306 US 11097306 US 9730605 A US9730605 A US 9730605A US 2005245943 A1 US2005245943 A1 US 2005245943A1
US11097306
US7354434B2 (en )
This application is a divisional of U.S. patent application Ser. No. 10/255,834, filed Sep. 27, 2002, which claims the benefit of priority from U.S. Provisional Patent Application No. 60/357,653, filed Feb. 20, 2002, and U.S. Provisional Patent Application No. 60/324,937, filed Sep. 27, 2001, the contents thereof are incorporated herein by reference.
U.S. Pat. No. 5,868,735 to Daniel M. Lafontaine, and U.S. Pat. No. 6,290,686, also to Lafontaine, both refer to cryogenic cooling of an angioplasty apparatus, as does U.S. patent application No. 20020032438 by Lafontaine.
U.S. patent application No. 20020010460, submitted by James Joye et. al. similarly refers to a cryosurgery probe usable to perform angioplasty, which probe enables cryogenic cooling of tissues at an angioplasty site. Joye refers to an apparatus in which a single balloon may function for both cryogenic cooling and for dilation.
Joye's application similarly contemplates cooling by evaporation. Throughout his disclosure, Joye presents and discusses cooling by evaporation from supplied cooling liquids or liquid/gas mixtures such as carbon dioxide (CO.sub.2), nitrous oxide (N.sub.20), liquid nitrogen (N.sub.2), a fluorocarbon such as AZ-50.TM. (sold by Genetron of Morristown, N.J.), or the like. Similar systems are presented U.S. Pat. No. 6,355,029 to Joye et, al. and in U.S. Pat. No. 5,971,979, also to Joye et. al.
It is to be noted that in each of the above-mentioned documents Joye refers in passing to the possibility of use of a Joule-Thomson orifice in the delivery of a cryogenic cooling fluid into an angioplasty balloon, yet in each of the documents, all of the implementation details refer to delivery of a liquid rather than a gas into a balloon or other volume to be cryogenically cooled. In this sense, the embodiments described in detail by Joye are similar to those described by Lafontaine in the patents cited hereinabove, in that evaporation of a liquid, a phase transition from a liquid to a gaseous state, is the cooling mechanism described. Thus, for example, Joye states in one context “the cryogenic fluid will flow through the tube 22 as a liquid at an elevated pressure and (thus inhibiting flow restrictive film boiling) will expand across the orifice 23 to a gaseous state at a lower pressure within the balloon.” And similarly: “The methods of the present invention may be performed with cryosurgical catheters comprising a catheter body having a proximal end, a distal end, and a primary lumen therettrough. The primary lumen terminates in a Joule-Thomson orifice at or near its distal end, and a balloon is disposed over the orifice on the catheter body to contain a cryogenic fluid delivered through the primary lumen. Suitable cryogenic fluids will be non-toxic and include liquid nitrogen, liquid nitrous oxide, liquid carbon dioxide, and the like. By delivering the cryogenic fluid through the catheter body, the balloon can be expanded and cooled in order to effect treatments according to the present invention.”
Various other patents similarly refer to cooling by evaporation as a method of cryogenic cooling of an angioplasty balloon catheter. U.S. patent application No. 20020045892 by Hans W. Kramer is an additional example of a system utilizing evaporation of a liquid such as perfluorocarbon to achieve cryogenic cooling in a balloon catheter. U.S. Pat. No. 5,147,355 to Peter Friedman is yet another example of a system utilizing evaporation of a liquid to achieve cryogenic cooling.
With respect to another aspect of cryogenic balloon angioplasty, U.S. patent application No. 20020045894 by James Joye et. al. presents an additional system for cryogenic cooling by evaporation, this system comprising a double balloon catheter, a first balloon being inflated by a pressurized gas, and a second balloon containing the first balloon, with a vacuum between the two. In U.S. patent application No. 20020045894 Joye presents a safety interlock system, whereby a rise in pressure in the outer balloon is interpreted to signal a leak in the inner balloon, and detection of such a rise in pressure causes his system to cut off supply of pressurized fluid to the inner balloon, thereby avoiding an irruption of pressurized fluid into the tissues of a patient undergoing a surgical intervention. We note, however, a disadvantage of the described safety interlock system, in that it is designed to detect such a leak only after a significant rise in pressure has occurred within the outer balloon.
According to still faker features in the described preferred embodiments, the Joule-Thomson orifice is shaped and oriented so as to induce in gasses passing therethrough into the first variable volume a motion selected from a group consisting of circular motion, swirling motion, and turbulent motion.
The present invention further successfully addresses the shortcomings of the presently known configurations by providing apparatus and method of cryogenic cooling of the balloon of an angioplasty balloon catheter, which method and apparatus provide for accurate control of temperature of the balloon during cooling, and further provide a hilly evenly distribution of cold throughout that balloon catheter.
FIG. 12 is a simplified schematic presenting an alternate configuration for a cryocatheter system, including separate heat exchanging configurations for cooling gas and for heating gas, according to an embodiment of the present invention, FIG. 13 is a simplified schematic presenting a cryocatheter comprising an injection lumen and a guide-wire lumen, according to an embodiment of the present invention;
The phrase “heat-exchanging configuration” is used herein to refer to component configurations traditionally )mown as “heat exchangers”, namely configurations of components situated in such a manner as to facilitate the passage of heat from one component to another. Examples of “heat-exchanging configurations” of components include a porous matrix used to facilitate heat exchange between components, a structure integrating a tunnel within a porous matrix, a structure including a coiled conduit within a porous matrix, a structure including a first conduit coiled around a second conduit, a structure including one conduit within another conduit, or any similar structure.
The phrase “Joule-Thomson heat exchanger” as used herein refers, in general, to any device used for cryogenic cooling or for heating, in which a gas is passed from a first region of the device, wherein it is held under higher pressure, to a second region of the device, wherein it is enabled to expand to lower pressure. A Joule-Thomson heat exchanger may be a simple conduit, or it may include an orifice through which gas passes from the first, higher pressure, region of the device to the second, lower pressure, region of the device. A Joule-Thomson heat exchanger may further include a heat-exchanging configuration, for example a heat-exchange configuration used to cool gasses within a first region of the device, prior to their expansion into a second region of the device.
The phrase “cooling gasses” is used herein to refer to gasses which have the property of becoming colder when passed through a Joule-Thomson heat exchanger. As is well known in the art, when gasses such as argon, nitrogen, air, krypton, CO2, CF4, xenon, and N2O, and various other gases pass from a region of higher pressure to a region of lower pressure in a Joule-Thomson heat exchanger, these gasses cool and may to some extent liquefy, creating a cryogenic pool of liquefied gas. This process cools the Joule-Thomson heat exchanger itself, and also cools any thermally conductive materials in contact therewith. A gas having the property of becoming colder when passing through a Joule-Thomson heat exchanger is referred to as a “cooling gas” in the following.
As used herein, a “Joule Thomson cooler” is a Joule Thomson heat exchanger used for cooling As used herein, a “Joule Thomson heater” is a Joule Thomson heat exchanger used for heating.
As used herein, the term “angioplasty” is used to refer in particular to balloon angioplasty, As used herein, the term “cryoplasty” is used to refer to angioplasty in which standard angioplasty procedures are supplemented by cooling of treated tissues, either during angioplasty or subsequent to angioplasty.
Gas input lumen 104, designed to contain and transport high-pressure gas; is preferably constructed of high strength flexible metal such as stainless steel or Cupro-Nickel, or of high strength plastic tubing.
FIG. 1A presents a presently preferred construction, in which cooling gas from input lumen 104, having expanded and cooled, directly cools balloon 110; FIG. 1B presents an alternative construction, in which volume 112 is further contained within a tube 120, preferably constructed of plastic or metal, and tube 120 is further contained in a heat-transmission layer 122, preferably containing a liquid or a gel.
If the incoming gas is a cooling gas, temperate of his input gas is reduced drastically through the Joule-Thomson effect as it passes into balloon 110, reaching a temperature preferably between 0C. and −186C., and more preferably between −90C. and −140C. Attainable temperatures on the surface of balloon 110, in contact with body tissue, are between −10C. and −80C. Attainable temperature gradients for freezing and thawing are up to 100C. per second.
Valve 132 may be implemented as a manual valve, yet valve 132 is preferably implemented as a remotely controlled valve under control of control system 150. Control system 150 is preferably operable to control flow of exhaust gas through valve 132. Control system 150 is further operable to control flow of input gasses to balloon 110, as will be shown hereinbelow. Combined control of input of gas into balloon 110 and output of exhaust gas from balloon I 10 enables control module 150 to establish and maintain a desired pressure within balloon 110, or indeed to establish an maintain a desired pressure profile over time, according to a pre-planned treatment profile or to real-time preferences of an operator responding to real-time requirements of a therapeutic procedure.
Attention is now drawn to FIG. 5, which is a simplified schematic of a cryocatheter having a Joule-Thomson orifice shaped and oriented so as to induce selected patterns of motion in gasses passing therethrough; according to an embodiment of the present invention.
Attention is now drawn to FIG. 6, which is a simplified schematic of a cryocatheter comprising a plurality of Joule-Thomson orifices, according to an embodiment of the present invention. As illustrated in FIG. 6, a catheter 100 comprises a plurality of Joule-Thomson orifices 108, some or all of which may be formed and oriented as shaped nozzles 180 designed and constructed to induce a selected form of motion in gas passing therethrough. The configuration presented in FIG. 6 may be used to ensure good circulation of cool gas within balloon 110 so as to enhance even distribution of cooling throughout balloon 110. Alternatively, a configuration similar to that presented in FIG. 6, but wherein a plurality of orifices 108 are concentrated in a selected area of balloon 110 and distanced from other parts of balloon 1 10, may be utilized to concentrate cooling in a selected portion of balloon 110, and to lessen the degree of cooling in non-selected portions of balloon 110.
Attention is now drawn to FIG. 7, which is a simplified schematic of a cryocatheter comprising flow control structures for directing a flow of gas within an angioplasty balloon, according to an embodiment of the present invention As was shown above with respect to FIGS. 5 and 6, selected number, placement, shape, and orientation of gas delivery orifices 108 can produce a configuration which enhances even distribution of cooling gas throughout balloon 1 10, or alternatively can be used to produce a configuration which concentrates cooling in a selected portion of balloon 110. FIG. 7 presents an alternative (or complementary) configuration useable to enhance evenly distributed cooling or, alternatively, to achieve selectively concentrated cooling.
A currently preferred method of maintaining operational safety of catheter 100 is to mix a selected portion of helium gas with cooling gas, or with any other fluid used to inflate balloon 110, not only prior to inflating balloon 110, but also during normal inflation and cooling operations of catheter 100 as well. According to this preferred method, at least a small amount of helium gas is added to whatever cooling gas or other fluid is used to inflate balloon 110. The extreme sensitivity of available helium detectors 220 ensures that even a small leak of helium will permit leak detection, even when the amount of helium added to a fluid (e.g., a cooling gas) supplied to balloon 11 0 is sufficiently small to have little or no substantial effect on the gas temperature obtained when such a gas mixture passes from a high pressure area to a low pressure area through Joule-Thomson orifice 108. Thus, utilizing a cooling gas containing at least a small portion of helium gas, and utilizing a helium gas detector 220 as illustrated, enables to detect leaks or faults in balloon 110 with a high degree of precision and during the entire course of an angioplasty and/or cryoplasty procedure, thus greatly enhancing the safety of such a procedure.
Gas supplies 232 and 236, input valves 234 and 238, and one-way valves 240 and 242, together constitute a gas supply module 230. Gas supply module 230 is operable to supply compressed cooling gas, to supply compressed heating gas, and to supply a mixture containing both compressed cooling gas and compressed beating gas. Valves 234 and 238 together constitute a mixed-gas input valve system operable to control delivery of mixed gas from gas supply module 230 to gas input lumen 104, and further operable to control the ratio of cooling gas to heating gas in a mixed gas supplied to gas input lumen 104. In an alternative construction, valves 234 and 238 may be combined into a proportional valve governing the proportion of cooling gas to heating gas delivered to gas input lumen 104.
In an alternative construction, a pre-mixed compressed gas supply 246, flow from which is controlled by a pre-mixed gas input valve 248, may also supply gas, through a one-way valve 250, to gas input lumen 104. Premixed compressed gas supply 246 contains a mixture of cooling gas and heating gas in selected proportion. Mixed gas supply 246 may be used instead of, or in conjunction with, cooling gas supply 232 and heating gas supply 236.
Control module 150 provides various control and monitoring functions for the system presented in FIG. 9. Control module 150 preferably comprises a data collection unit 260 for receiving data generated by at least one sensor positioned in or near a distal portion of catheter 100, such as thermal sensors 140 and pressure sensors 141. Control module 150 preferably further comprises a processing unit 262 for evaluating data received by data collection unit 260 according to a stored algorithm 264, and a command module 265 for sending commands to one or more remotely controlled gas flow valves, such as valves 234,248,238, and 132.
Catheter 100, designed for insertion into the body, is conceptually divided into three sections. Endovascular-precoronary section 280 comprises flexible tube 160, designed to be flexibly inserted into a blood vessel or other bodily conduit of a patient Coronary section 282, preferably about 25 cm in length, is designed to enter the coronary region of the body during an angioplasty procedure. Distal portion 102 consists primarily of inflatable balloon 110, and optional second inflatable balloon 210.
The configuration presented by FIG. 12 is useful because efficient heat exchange, in heat exchanging configurations 170C, 170D, and 170E, requires a relatively large internal volume of gas within those heat exchanging configurations. Using a common heat exchanging configuration 170C both to pre-cool cooling gas and to pre-heat heating gas, as is done in the configuration presented by FIG. 11, has an effect of reducing speed of response of system 90 to a change from a first gas input (e-g., cooling gas) to a second gas input (e.g., heating gas), since a relatively large volume of a first gas must be flushed from heat exchanging configuration 170C before heat exchanging configuration 170C can be entirely filled with, and dedicated to the pre-cooling or pre-heating of, an intended second gas.
A more rapid response to a change from cooling to heating, or from heating to cooling, maybe obtained from the configuration presented in FIG. 12, wherein each gas source has a dedicated heat exchanging configuration, 170D dedicated to pre-cooling cooling gas, and 170E dedicated to pre-heating heating gas. Input valves 234A and/or 234B and 238A and/or 2383 need merely be closed and opened appropriately, to produce an almost immediate response from gas supply module 230, with no delay required for flushing the system of inappropriate gas.
In FIG. 16, angioplasty balloon catheter 300 comprises an inflatable balloon 310 operable to perform angioplasty, and a plurality of temperature sensors 320 (also called “thermal sensors” and “heat sensors” in the following) arranged along a selected section of catheter 300. Catheter 300 may have the characteristics of catheter 100 described hereinabove, or alternatively may be a cryogenic balloon catheter coolable using methods of prior art, or further alternatively may be a cryogenic balloon catheter coolable using other methods of cooling, or yet firer alternatively catheter 300 may be an angioplastic balloon catheter not comprising mechanisms for cooling balloon 310.
Attention is now drawn to FIG. 19, which is a simplified schematic presenting an alternate scheme of placement for thermal sensors along a section of an angioplasty balloon catheter, according to an embodiment of the present invention FIG. 19 presents a section of catheter similar to that presented in FIG. 17, with the difference that in an alternative construction presented in FIG. 19, thermal sensors 320 are sly positioned around and along a selected segment of catheter 300, thus enabling temperature readings an all sides of catheter 300 along that selected length of catheter 300.
ii) increasing temperature of gasses passing through said Joule-Thomson orifice by proportionally decreasing a ratio of cooling gas to heating gas in said gas mixture,
US11097306 2001-09-27 2005-04-04 Method of controlling the temperature of gasses passing through a Joule-Thomson orifice Expired - Fee Related US7354434B2 (en)
US35765302 true 2002-02-20 2002-02-20
US10255834 US6875209B2 (en) 2001-09-27 2002-09-27 Cryoplasty apparatus and method
US11097306 US7354434B2 (en) 2001-09-27 2005-04-04 Method of controlling the temperature of gasses passing through a Joule-Thomson orifice
US11171385 US20050240117A1 (en) 2001-09-27 2005-07-01 Thermal sensing device for thermal mapping of a body conduit
US20050245943A1 true true US20050245943A1 (en) 2005-11-03
US7354434B2 US7354434B2 (en) 2008-04-08
ID=26984693
US10490114 Abandoned US20040260328A1 (en) 2001-09-27 2002-09-26 Cryoplasty apparatus and method
US10255834 Expired - Fee Related US6875209B2 (en) 2001-09-27 2002-09-27 Cryoplasty apparatus and method
US11097306 Expired - Fee Related US7354434B2 (en) 2001-09-27 2005-04-04 Method of controlling the temperature of gasses passing through a Joule-Thomson orifice
US11171385 Abandoned US20050240117A1 (en) 2001-09-27 2005-07-01 Thermal sensing device for thermal mapping of a body conduit
US (4) US20040260328A1 (en)
CA (1) CA2461217A1 (en)
EP (1) EP1429820A4 (en)
WO (1) WO2003026719A3 (en)
US7254959B1 (en) * 2006-04-19 2007-08-14 Cogo Aire Llc Joule-Thomson effect air conditioner using air as the refrigerant
US20130282083A1 (en) * 2009-04-29 2013-10-24 Tomophase Corporation Image-guided thermotherapy based on selective tissue thermal treatment
WO2014070798A1 (en) * 2012-10-29 2014-05-08 Forever Young International, Inc. Temperature changing intracorporeal fluid delivery devices
US3733280A (en) * 1970-11-18 1973-05-15 Fmc Corp Polymers derived from chloromaleic anhydride as detergent builders
US6875209B2 (en) 2005-04-05 grant
EP1429820A2 (en) 2004-06-23 application
JP2005503241A (en) 2005-02-03 application
US20040260328A1 (en) 2004-12-23 application
EP1429820A4 (en) 2007-11-14 application
WO2003026719A3 (en) 2004-04-08 application
US7354434B2 (en) 2008-04-08 grant
WO2003026719A2 (en) 2003-04-03 application
CA2461217A1 (en) 2003-04-03 application
US20030060762A1 (en) 2003-03-27 application
US20050240117A1 (en) 2005-10-27 application
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:ZVULONI, RONI;BLIWEIS, MORDECHAI;SCHECHTER, DORIS;AND OTHERS;REEL/FRAME:038376/0828