WO2013074083A1 - Système à boucle fermée à régulation de pression et écoulement cryochirurgicaux - Google Patents

Système à boucle fermée à régulation de pression et écoulement cryochirurgicaux Download PDF

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Publication number
WO2013074083A1
WO2013074083A1 PCT/US2011/060720 US2011060720W WO2013074083A1 WO 2013074083 A1 WO2013074083 A1 WO 2013074083A1 US 2011060720 W US2011060720 W US 2011060720W WO 2013074083 A1 WO2013074083 A1 WO 2013074083A1
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WO
WIPO (PCT)
Prior art keywords
cryogen
pressure
reservoir
gaseous
source
Prior art date
Application number
PCT/US2011/060720
Other languages
English (en)
Inventor
Nir Berzak
Simon Sharon
Nadav Lavochkin
Original Assignee
Icecure Medical Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Icecure Medical Ltd. filed Critical Icecure Medical Ltd.
Priority to JP2014541029A priority Critical patent/JP2015500675A/ja
Priority to PCT/US2011/060720 priority patent/WO2013074083A1/fr
Publication of WO2013074083A1 publication Critical patent/WO2013074083A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00023Cooling or heating of the probe or tissue immediately surrounding the probe with fluids closed, i.e. without wound contact by the fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0212Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument inserted into a body lumen, e.g. catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0231Characteristics of handpieces or probes
    • A61B2018/0262Characteristics of handpieces or probes using a circulating cryogenic fluid

Definitions

  • Embodiments of the present invention relate to cryogen flow regulation systems and, more particularly, to devices and systems for regulating pressure in a closed loop in which pressure is at least partially regulated through regulating flow through the system.
  • the present invention in at least some embodiments, is an advance over the background art by providing cryosurgical systems and devices that exhibit l smooth, constant pressure regulation and in which pressure is at least partially regulated through flow regulation.
  • An aspect of the present invention provides a system for selectively cooling and warming a tip of a cryosurgical instrument using a dual phase cryogen.
  • the system includes: two sources of the cryogen, a first source storing the cryogen in a liquid phase and having a first source heater therein that selectively heats the liquid phase cryogen so as to convert at least some of the liquid phase cryogen stored therein into gaseous phase cryogen and a second source storing the cryogen in a gaseous phase; a first delivery path between the first source and the tip; a second delivery path between the second source and the tip; a cryogen delivery control section that selectively delivers cryogen to the tip from the respective sources; a cryogen return path from the tip to the first and second sources; a cryogen return control section that controls the return of cryogen via the cryogen return path and that includes a pump that pumps the returning cryogen to the second source; and a pressure control section including a first pressure sensor that senses a pressure in the first source, a second pressure sensor that senses a
  • Another aspect of the present invention provides an apparatus for delivering a phase changing cryogen to a surgical device, including: a first reservoir of the cryogen in a liquid phase; a liquid feed conduit through which cryogen travels from the first reservoir to the surgical device; a second reservoir of the cryogen in a gaseous phase; a gaseous feed conduit through which cryogen travels from the second reservoir to the surgical device; a return conduit through which cryogen that is exhausted from the surgical device returns to the first and/or second reservoir, the exhausted cryogen being in the gaseous phase; a pump disposed in the return conduit, the pump selectively pumping the returning cryogen to the first reservoir and/or the second reservoir; and a logic section that selectively energizes the pump to control an overall pressure in the system, based on information from pressure sensors and flow meters.
  • Still another aspect of the present invention provides a system including: a first cryogen delivery loop including a liquid cryogen storage section in fluid communication with a cryosurgical device via (i) a liquid cryogen delivery path and (ii) a cryogen return path; and a second cryogen delivery loop including a gaseous cryogen storage section in gaseous communication with (i) the cryosurgical device via a gaseous cryogen delivery path and a portion of the return path and (ii) the liquid cryogen storage section via a portion of the cryogen return path.
  • the cryogen return path delivers exhausted, gaseous cryogen from the cryosurgical device to the first and/or the second cryogen storage section, includes a heater that selectively heats the exhausted, gaseous cryogen to maintain a temperature thereof above a boiling temperature of the cryogen, and includes a pump that selectively increases a local pressure in the cryogen return path.
  • a heater that selectively heats the exhausted, gaseous cryogen to maintain a temperature thereof above a boiling temperature of the cryogen
  • a pump that selectively increases a local pressure in the cryogen return path.
  • Yet another aspect of the present invention provides a system for selectively cooling and warming a tip of a cryosurgical instrument using a dual phase cryogen, including: two sources of the cryogen, a first source storing the cryogen in a liquid phase and having a first source heater therein that selectively heats the liquid phase cryogen so as to convert at least some of the liquid phase cryogen stored therein into gaseous phase cryogen and a second source storing the cryogen in a gaseous phase; a first delivery path between the first source and the tip; a second delivery path between the second source and the tip and including a gaseous phase cryogen heater that heats gaseous phase cryogen traveling therein from the second source to the tip; a cryogen delivery control section that selectively delivers cryogen to the tip from the respective sources; a cryogen return path from the tip to the first and second sources; a cryogen return control section that controls the return of cryogen via the cryogen return path and that includes a cryogen heater that selectively heats cryogen in the cryogen return
  • Still another aspect of the present invention provides a system for selectively cooling and warming a tip of a cryosurgical instrument using a dual phase cryogen.
  • the system includes: two sources of the cryogen, a first source storing the cryogen in a liquid phase and having a container contained completely within said first source, said container also containing the cryogen in a liquid phase, said container communicating fluidly with said first source through a check valve, wherein if pressure is greater in said first source than in said container, said check valve opens and cryogen in said liquid phase flows from said first source to said container; a second source storing the cryogen in a gaseous phase; a first delivery path between the first source and the tip; a second delivery path between the second source and the tip; a cryogen delivery control section that selectively delivers cryogen to the tip from the respective sources; a cryogen return path from the tip to the first and second sources; a cryogen return control section that controls the return of cryogen via the cryogen return path and that includes a pump that pumps the returning cryogen to the
  • cryoprobe is provided as a non-limiting example of a cryosurgical instrument. And, although embodiments and/or aspects of the present invention are discussed in the context of a cryoprobe, it is to be understood that other cryosurgical instruments are both contemplated and intended to be included.
  • the present invention in at least some embodiments effectively regulates "two-phase flow", in which the cryogen both flows and boils, thereby controlling the level of the heat flux.
  • FIG. 1 shows a closed loop system 100 consistent with an embodiment of the present invention
  • FIG. 2 shows a closed loop system 200 consistent with an embodiment of the present invention featuring a constantly operating pump
  • FIG. 3 shows a closed loop system 300 consistent with an embodiment of the present invention featuring an additional structure to generate gaseous cryogen
  • FIG. 4 shows a partial view of a closed loop system 400 consistent with an embodiment of the present invention featuring additional pressure control structure.
  • FIG. 1 there is illustrated a closed loop system 100 for recycling a gaseous cryogen in a pressurized manner, while the pressure and the flow in the system are regulated.
  • the system 100 includes a source of liquid cryogen 104, a source of gaseous cryogen 102, a cryoprobe 117, and structures providing various cryogen flow paths, which are discussed in detail below.
  • the source of liquid cryogen 104 is connected to the cryoprobe 117 via, in series from upstream to downstream, a line 118, a two-way valve, 121, and a cryoprobe inlet 116.
  • the source of gaseous cryogen 102 is connected to the cryoprobe 117 via, in series from upstream to downstream, a line 110, a two-way valve 113, a line 115, a two-way valve 112, a heater 105, and a cryoprobe inlet 108.
  • the cryoprobe 117 is connected to the gaseous cryogen source 102 via, in series from upstream to downstream, a line 119, a two-way valve 120, a line 123, a heater 122, and line 124, a pump 134, a line 132, and a two-way valve 106.
  • a flow meter 182 and a relief valve 107 may be connected to line 124 between the heater 122 and the pump 134.
  • the cryoprobe 117 is connected to the liquid cryogen source 104 via, in series, a line 133 that is connected to line 132 at a point between the pump 134 and the two-way valve 106, two-way valves 103 and 130, a line 129, and a pressure indicator 181.
  • a pressure regulator connected to a line 135 that interconnects the two-way valve 130 and the line 115.
  • a cryoablation procedure may include one or more alternating cooling and active thawing processes, which follow an initialization procedure.
  • Operation of the system 100 is discussed.
  • liquid cryogen exits from source 104 through the line 118.
  • Flow is controlled by either the pressure regulator 101, or by the two-way valve 121, although during the freezing process the two-way valve 121 is typically in the open state.
  • the flow of the liquid cryogen is controlled as the liquid cryogen boils, thereby limiting the heat flux to assure smooth operation, as previously described.
  • Cryogen then enters through the inlet 116 and into the cryoprobe 117 where it then cools a tip 124, which may optionally be solid or hollow.
  • Exhausted cryogen i.e., cryogen that has cooled the surrounding environment through boiling and has expanded, as the liquid portion of the cryogen is reduced relative to the gaseous portion
  • the exhausted cryogen then passes through the two-way valve 120 and is optionally heated by the heater 122 to ensure that the return line temperature is above the boiling temperature of the cryogen, such that the exhausted cryogen is maintained in a gaseous state.
  • the cryogen is not heated.
  • the gaseous cryogen then flows through a line 124 and a flow meter 182, which measures the rate of flow of cryogen through the line 124.
  • this flow rate information is one component upon which the pressure regulation for system 100 is based.
  • gaseous cryogen may be exhausted through a relief valve 107.
  • the gaseous cryogen if not exhausted, then passes to the pump 134, which is controlled to maintain the desired pressure in system 100.
  • Pump 134 pumps the gaseous cryogen to gaseous cryogen source 102 through the line 132 and then through the two way valve 106.
  • the desired gaseous state of the cryogen upon entering pump 134 is maintained by the heater 122, as previously described.
  • the gaseous cryogen may be pumped through the two- way valve 103 to the line 131 and hence through the two way valve 130 to the liquid cryogen source 104 through the line 129. This optional flow path may be advantageous in maintaining the desired pressure differential between the liquid cryogen source 104 and the gaseous cryogen source 102 as described in greater detail below.
  • System pressure is measured at liquid cryogen source 104 by the pressure gauge 181 and at the gaseous cryogen source 102 by the pressure gauge 184.
  • pressure is higher at the source of gaseous cryogen 102 than at the source of liquid cryogen 104.
  • the pressure regulator 101 and the pump 134 control the overall pressure of system 100.
  • pressure regulator 101 receives information regarding the pressure of system 100 from pressure gauge 181 and flow meter 182 and, based on this received information, the activity of pump 134 may be adjusted through a suitable electronic circuit (not shown) such that the pressure in the gaseous cryogen source 102 is preferably maintained at a higher level than the pressure in the liquid cryogen source 104.
  • cryogen gas may be exhausted through valve 107.
  • gaseous cryogen may be exhausted through the relief valve 191.
  • gaseous cryogen is recycled to gaseous cryogen source 102 and the desired pressure is maintained in system 100.
  • the gaseous cryogen flows from gaseous cryogen source 102 through the line 110, the two-way valve 113, the line 115, the two-way valve 112 and is heated by the heater 105, after which the heated gaseous cryogen enters the cryoprobe 117 through the inlet 108.
  • This gaseous cryogen continues to flow through the line 119 to the pump 134.
  • Pump 134 raises the pressure of the gaseous cryogen and returns the gaseous cryogen to the gaseous cryogen source 102.
  • valve 107 remains closed and the gaseous cryogen is fully recycled.
  • the pump 134 is first pumping either air or cryogen into source 104, by opening valves 103 and 130 for line 129, and also by opening valve 107 to permit entry of air.
  • valve 103 closes and valve 106 opens to deliver the compressed gas to the source 102, until the pressure at source 102 reaches another determined value, as read by pressure sensor 184.
  • pump 134 is primarily activated to return cryogen to the source 102 through the valve 106, as long as the pressure as measured by pressure meter 181 is maintained at the desired value or range of values. If the pressure meter 181 indicates that the pressure is below the desired value threshold, then pump 134 forces the cryogen through valves 103 and 130 into the source 104. During the active thawing phase of operation, pump 134 simply recycles the cryogen through valves 106, 113, 112 and 120 through lines 110, 108 and 119.
  • FIG. 2 there is illustrated a system 200 consistent with an embodiment of the present invention.
  • the system 200 operates similarly to system 100 of FIG. 1. Thus, for ease of explanation, like components between systems 100 and 200 share corresponding reference numbers and detailed description thereof is omitted.
  • a feature of the system 200 that differentiates it from the system 100 is that pump 234 operates constantly to recycle the cryogen return gas.
  • the pump 234 is preferably able to pump both liquid cryogen and gaseous cryogen.
  • the pressure regulator 201 preferably controls the exhaust of excess gaseous cryogen through a relief valve 291 at liquid cryogen source 204.
  • Pressure gauge 292 is preferably located between liquid cryogen source 204 and relief valve 291, to determine the pressure at liquid cryogen source 204.
  • the operation of heater 222 is reserved only for cases when the gaseous cryogen is exhausted through relief valve 207.
  • FIG. 3 there is illustrated a system 300 consistent with an embodiment of the present invention.
  • the system 300 operates similarly to system 100 of FIG. 1.
  • like components between systems 100 and 300 share corresponding reference numbers and detailed description thereof is omitted.
  • a feature of the system 300 that differentiates it from the system 100 is the presence of additional structure to generate gaseous cryogen in order to fill gaseous cryogen source 302.
  • the sources of cryogen 302 and 304 are connected by line 352, a two-way valve 353, and a line 354, in series from the source 304 to the source 302.
  • a heater 351 disposed in the source 304.
  • the additional structure In operation, the additional structure generates gaseous cryogen by energizing heater 351 to heat and boil liquid cryogen in the liquid cryogen source 304.
  • the gaseous cryogen at liquid cryogen source 304 is then preferably directly transferred to gaseous cryogen source 302 through a line 352 and a two-way valve 353, thereby rapidly increasing the pressure at gaseous cryogen source 302 to the desired pressure and more rapidly enabling system 300 to achieve the desired system pressure.
  • the additional structure is preferably operative during the initiation of the activity of system 300 (i.e., upon initiation of cryotherapy).
  • FIG. 4 there is illustrated a portion system 400 consistent with an embodiment of the present invention.
  • the system 400 operates similarly to system 100 of FIG. 1.
  • like components between systems 100 and 400 share corresponding reference numbers and detailed description thereof is omitted.
  • the pressure control structure includes a closed container 451, a line 452 extending from one end of the closed container, and a check valve 461 at another end of the closed container.
  • a heater 467 is disposed in the closed container 451 and is controlled by a control circuit 462.
  • the first source 404 contains liquid cryogen. Inside of the first source 404 there is an additional closed container 451. The container 451 permits cryogen to flow in through a check valve 461 when the pressure in first source 404 is greater than the pressure in container 451. When an electrical heater 467 is activated, the pressure in the container 451 is raised and the check valve 461 is closed.
  • gaseous cryogen flows in the direction 464 which connects container 451 with the second source of gaseous cryogen (not shown), at a pressure set by pressure regulator 463.
  • liquid cryogen flows through a filter 414, when valve 421 is open to a cryoprobe
  • cryosurgical device in the direction indicated by the arrow 465.
  • pressured gaseous cryogen enters through a line 429, upstream of which is an additional pressure regulator of in the direction indicated by 466.
  • the electrical heater 467 is activated and boils the cryogen in container 451.
  • the pressure regulator 463 opens and the compressed gaseous cryogen is transferred in the direction 464 to the second source (not shown).
  • the system 400 operates in a manner at least similar to system 100.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Otolaryngology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un système pour administrer un cryogène à changement de phase à un dispositif chirurgical, lequel système comprend : un premier réservoir du cryogène dans une phase liquide ; un conduit d'alimentation en liquide à travers lequel un cryogène se déplace du premier réservoir au dispositif chirurgical ; un second réservoir du cryogène dans une phase gazeuse ; un conduit d'alimentation en gaz à travers lequel un cryogène se déplace du second réservoir au dispositif chirurgical ; un conduit de retour à travers lequel un cryogène qui est évacué du dispositif chirurgical retourne dans le premier/ou second réservoir ; une section de commande de retour de cryogène qui commande le retour du cryogène par le trajet de retour de cryogène et qui comprend une pompe ; une section de régulation de pression comprenant un premier capteur de pression, un second capteur de pression et un régulateur de pression qui régule la pression du premier réservoir sur la base d'information provenant des capteurs de pression.
PCT/US2011/060720 2011-11-15 2011-11-15 Système à boucle fermée à régulation de pression et écoulement cryochirurgicaux WO2013074083A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2014541029A JP2015500675A (ja) 2011-11-15 2011-11-15 閉ループ低温外科圧力及び流動調節型システム
PCT/US2011/060720 WO2013074083A1 (fr) 2011-11-15 2011-11-15 Système à boucle fermée à régulation de pression et écoulement cryochirurgicaux

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2011/060720 WO2013074083A1 (fr) 2011-11-15 2011-11-15 Système à boucle fermée à régulation de pression et écoulement cryochirurgicaux

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109674525A (zh) * 2018-12-21 2019-04-26 海杰亚(北京)医疗器械有限公司 一种用于医用冷冻球囊的治疗设备

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7146935B2 (ja) 2018-04-27 2022-10-04 バイオコンパティブルズ ユーケー リミテッド 圧力調整機能を備えた冷凍凝固手術システム

Citations (6)

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Publication number Priority date Publication date Assignee Title
US5334181A (en) 1990-09-26 1994-08-02 Cryomedical Sciences, Inc. Cryosurgical system for destroying tumors by freezing
US5520682A (en) 1991-09-06 1996-05-28 Cryomedical Sciences, Inc. Cryosurgical instrument with vent means and method using same
US7192426B2 (en) 2001-05-31 2007-03-20 Endocare, Inc. Cryogenic system
US20070149957A1 (en) 2005-12-23 2007-06-28 Sanarus Medical, Inc. Low pressure liquid nitrogen cryosurgical system
US20090270851A1 (en) 2008-04-24 2009-10-29 Babkin Alexei V Method and System for Cryoablation Treatment
US7938822B1 (en) * 2010-05-12 2011-05-10 Icecure Medical Ltd. Heating and cooling of cryosurgical instrument using a single cryogen

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Publication number Priority date Publication date Assignee Title
JP2596255B2 (ja) * 1991-05-15 1997-04-02 日本電気株式会社 液体冷媒循環システム

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5334181A (en) 1990-09-26 1994-08-02 Cryomedical Sciences, Inc. Cryosurgical system for destroying tumors by freezing
US5520682A (en) 1991-09-06 1996-05-28 Cryomedical Sciences, Inc. Cryosurgical instrument with vent means and method using same
US7192426B2 (en) 2001-05-31 2007-03-20 Endocare, Inc. Cryogenic system
US20070149957A1 (en) 2005-12-23 2007-06-28 Sanarus Medical, Inc. Low pressure liquid nitrogen cryosurgical system
US20090270851A1 (en) 2008-04-24 2009-10-29 Babkin Alexei V Method and System for Cryoablation Treatment
US7938822B1 (en) * 2010-05-12 2011-05-10 Icecure Medical Ltd. Heating and cooling of cryosurgical instrument using a single cryogen

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109674525A (zh) * 2018-12-21 2019-04-26 海杰亚(北京)医疗器械有限公司 一种用于医用冷冻球囊的治疗设备

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