WO2010028409A4 - A cryogenic system and method of use - Google Patents

A cryogenic system and method of use Download PDF

Info

Publication number
WO2010028409A4
WO2010028409A4 PCT/US2009/062928 US2009062928W WO2010028409A4 WO 2010028409 A4 WO2010028409 A4 WO 2010028409A4 US 2009062928 W US2009062928 W US 2009062928W WO 2010028409 A4 WO2010028409 A4 WO 2010028409A4
Authority
WO
WIPO (PCT)
Prior art keywords
cryogen
pressurized
cryogenic
cryoprobes
cryogenic system
Prior art date
Application number
PCT/US2009/062928
Other languages
French (fr)
Other versions
WO2010028409A1 (en
Inventor
John M. Baust
John G. Baust
Anthony T. Robilotto
Kristi K. Snyder
Roy Cheeks
Rob G. Van Buskirk
Original Assignee
Dobson, Melissa, K.
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
Priority claimed from US12/553,005 external-priority patent/US9408654B2/en
Priority claimed from US12/562,301 external-priority patent/US8439905B2/en
Priority claimed from US12/607,721 external-priority patent/US8409184B2/en
Priority to CA2736221A priority Critical patent/CA2736221C/en
Priority to EP15179592.9A priority patent/EP3173041B1/en
Priority to EP09812404.3A priority patent/EP2330995B1/en
Application filed by Dobson, Melissa, K. filed Critical Dobson, Melissa, K.
Priority to ES09812404.3T priority patent/ES2551324T3/en
Priority to US13/061,171 priority patent/US8784409B2/en
Publication of WO2010028409A1 publication Critical patent/WO2010028409A1/en
Publication of WO2010028409A4 publication Critical patent/WO2010028409A4/en
Priority to US13/038,862 priority patent/US9089316B2/en
Priority to US13/077,399 priority patent/US20110184402A1/en
Priority to US14/336,317 priority patent/US20150018810A1/en
Priority to US14/715,092 priority patent/US20150257810A1/en
Priority to US14/808,750 priority patent/US9974592B2/en
Priority to US15/445,968 priority patent/US20170172791A1/en
Priority to US16/717,721 priority patent/US20200121498A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B18/0218—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques with open-end cryogenic probe, e.g. for spraying fluid directly on tissue or via a tissue-contacting porous tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17—STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17C—VESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C9/00—Methods or apparatus for discharging liquefied or solidified gases from vessels not under pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0212—Surgical 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0231—Characteristics of handpieces or probes
    • A61B2018/0262—Characteristics of handpieces or probes using a circulating cryogenic fluid
    • A61B2018/0268—Characteristics of handpieces or probes using a circulating cryogenic fluid with restriction of flow

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.

Claims

AMENDED CLAIMS received by the International Bureau on 09 March 2010 (09.03.2010)
1. (Currently amended) A cryogenic system comprising: a container having cryogen within said container; one or more cryoprobes outside said container for use in cryotherapeutic procedures; a heat exchanger surrounded by a subcooling chamber; at least one pressurized apparatus having one or more heaters arranged therein to form pressurized cryogen, at least one inlet port for filling said pressurized apparatus, at least one outlet port for releasing pressurized cryogen into said heat exchanger, and one or more control valves; a cryogenic pump submersed within the cryogen which delivers the cryogen to said inlet port of said pressurized apparatus; at least one supply line directing said pressurized cryogen to said one or more cryoprobes; and at least one return line which returns the cryogen from said one or more cryoprobes to said container or subcooling chamber;
wherein said pump in combination with said pressurized apparatus is configured to provide controlled continuous delivery of said pressurized cryogen to said heat exchanger and through to said one or more cryoprobes, said controlled continuous delivery configured for manual and remote control operation.
2. (Currently amended) The cryogenic system of claim 1 , wherein one or more of said pressurized apparati are configured with one or more manifolds for use in cryotherapeutic procedures to target cardiac tissue, cancerous tissue, undesired tissue, or irregularities; said one or more manifolds comprising an integral assembly for directing at least a first composition or at least a second composition, alone or in combination, wherein said first composition is a liquid and said second composition is a gas.
28
3. (Original) The cryogenic system of claim 1 , wherein two or more of said pressurized apparati are configured in series such that a sequential pulsation of said pressurized cryogen is delivered to said heat exchanger.
4. (Original) The cryogenic system of claim 1 , wherein said pressurized apparatus generates compressed liquid cryogen, critical cryogen, or supercritical cryogen.
5. (Currently amended) The cryogenic system of claim 1 , wherein said one or more cryoprobes comprises a condensation based vacuum insulated catheter including: one or more cryogenic lines internal to said condensation based vacuum insulated catheter and having an outer surface with enhanced nucleation sites; an outer sheath encasing said cryogenic lines and having a lumen therein filled with vapors that remain in a gaseous state at a controlled temperature and solidify upon cooling; and a formation of solid crystals along said outer surface of said one or more cryogenic lines and having low thermal conductivity;
wherein said formation of solid crystals upon said enhanced nucleation sites creates an evacuated space within said lumen.
6. (Original) The cryogenic system of claim 5, wherein said evacuated space is an insulative vacuum formed from non-equilibrating phase change gas.
7. (Original) The cryogenic system of claim 6, wherein said insulative vacuum is dependent on temperature reduction of said non-equilibrating phase change gas, said non-equilibrating phase change gas precipitating out of said lumen and solidifying upon said outer surface of said one or more cryogenic lines.
8. (Currently amended) The cryogenic system of claim 1 , wherein said one or more cryoprobes comprise a monitoring element, a sensor, or an optical imaging component, one or more thermocouples, an electrocardiogram monitor, one or more pressure transducers, and an electrophysiological sensor, individually or in any combination.
9. (Currently amended) The cryogenic system of claim 1 , wherein said one or more cryoprobes is rigid or flexible and directed to a target tissue site for a selected cryotherapeutic procedure, said one or more cryoprobes capable of being activated individually or collectively to produce a desired temperature or freeze duration.
10. (Currently amended) The cryogenic system of claim 5, wherein said one or more cryogenic lines have a unitary tubular structure which forms a closed loop tip.
11. (Currently amended) The cryogenic system of claim 10, wherein said unitary tubular structure forms a closed loop coil with or without an internal heat exchanger.
12. (Currently amended) The cryogenic system of claim 5, wherein said one or more cryogenic lines isolate a freeze zone at a distal end of said one or more cryoprobes, and said cryoprobes further comprising one or more sealed interfaces integrated with an inflatable cryogenic element.
13. (Currently amended) The cryogenic system of claim 1 , wherein said one or more cryoprobes is a cryogenic instrument comprising: an injection assembly having a mechanism for discharging one or more cryopellets to a targeted tissue; a storage clip supplying said injection assembly with said one or more cryopellets and having a means for maintaining sub-zero temperatures; an insertion needle having proximal end and a distal end and capable of directing said one or more cryopellets to said targeted tissue at said distal end.
14. (Currently amended) A method of delivering cryogen to a cryoprobe, said method comprising the steps of: providing a device containing cryogen, said device having one or more ports; providing a cryogenic pump submersed within the cryogen; providing one or more pressurized apparati within said device, said pressurized apparatus having an immersion heater contained therein, at least one inlet port, and at least one outlet port; providing an instrument outside said device for use in cooling processes, said instrument connected to one or more supply lines and one or more return lines which interconnect with said device; activating said cryogenic pump to fill said one or more pressurized apparati; activating said one or more pressurized apparati to form pressurized supercritical cryogen; and controllably directing said pressurized cryogen to said instrument through said one or more supply lines and from said instrument through said one or more return lines;
wherein said step of activating said one or more pressurized apparati includes a step of pressurizing each of said pressurized apparati and releasing said pressurized supercritical cryogen in a continual series of pulsations.
15. (New) The cryogenic system of claim 2, further comprising a control mechanism for varying the temperature of said first composition and said second composition, alone or in combination.
31
PCT/US2009/062928 2008-09-03 2009-11-02 A cryogenic system and method of use WO2010028409A1 (en)

Priority Applications (12)

Application Number Priority Date Filing Date Title
US13/061,171 US8784409B2 (en) 2008-09-03 2009-11-02 Cryogenic system and method of use
ES09812404.3T ES2551324T3 (en) 2008-09-03 2009-11-02 A cryogenic system and method of use
CA2736221A CA2736221C (en) 2008-09-03 2009-11-02 A cryogenic system and method of use
EP15179592.9A EP3173041B1 (en) 2009-09-02 2009-11-02 A cryogenic system
EP09812404.3A EP2330995B1 (en) 2008-09-03 2009-11-02 A cryogenic system and method of use
US13/038,862 US9089316B2 (en) 2009-11-02 2011-03-02 Cryogenic medical system
US13/077,399 US20110184402A1 (en) 2009-11-02 2011-03-31 Flexible Cryogenic Probe Tip
US14/336,317 US20150018810A1 (en) 2008-09-03 2014-07-21 Cryogenic system and method of use
US14/715,092 US20150257810A1 (en) 2009-11-02 2015-05-18 Flexible cryogenic probe tip
US14/808,750 US9974592B2 (en) 2008-09-03 2015-07-24 Cryogenic medical system
US15/445,968 US20170172791A1 (en) 2008-09-19 2017-02-28 Cryogenic System and Method of Use
US16/717,721 US20200121498A1 (en) 2008-09-03 2019-12-17 Cryogenic System and Method of Use

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
US9391608P 2008-09-03 2008-09-03
US61/093,916 2008-09-03
US9824408P 2008-09-19 2008-09-19
US61/098,244 2008-09-19
US12/553,005 2009-09-02
US12/553,005 US9408654B2 (en) 2008-09-03 2009-09-02 Modular pulsed pressure device for the transport of liquid cryogen to a cryoprobe
US12/562,301 US8439905B2 (en) 2008-09-19 2009-09-18 Nucleation enhanced surface modification to support physical vapor deposition to create a vacuum
US12/562,301 2009-09-18
US12/607,721 US8409184B2 (en) 2009-09-09 2009-10-28 Cryo-medical injection device and method of use
US12/607,721 2009-10-28

Related Parent Applications (3)

Application Number Title Priority Date Filing Date
US12/553,005 Continuation-In-Part US9408654B2 (en) 2008-09-03 2009-09-02 Modular pulsed pressure device for the transport of liquid cryogen to a cryoprobe
US12/553,005 Continuation US9408654B2 (en) 2008-09-03 2009-09-02 Modular pulsed pressure device for the transport of liquid cryogen to a cryoprobe
US12/562,301 Continuation US8439905B2 (en) 2008-09-03 2009-09-18 Nucleation enhanced surface modification to support physical vapor deposition to create a vacuum

Related Child Applications (3)

Application Number Title Priority Date Filing Date
US13/061,171 A-371-Of-International US8784409B2 (en) 2008-09-03 2009-11-02 Cryogenic system and method of use
US13/038,862 Continuation-In-Part US9089316B2 (en) 2008-09-03 2011-03-02 Cryogenic medical system
US14/336,317 Continuation US20150018810A1 (en) 2008-09-03 2014-07-21 Cryogenic system and method of use

Publications (2)

Publication Number Publication Date
WO2010028409A1 WO2010028409A1 (en) 2010-03-11
WO2010028409A4 true WO2010028409A4 (en) 2010-04-29

Family

ID=43897016

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2009/062928 WO2010028409A1 (en) 2008-09-03 2009-11-02 A cryogenic system and method of use

Country Status (5)

Country Link
US (2) US8784409B2 (en)
EP (1) EP2330995B1 (en)
CA (1) CA2736221C (en)
ES (1) ES2551324T3 (en)
WO (1) WO2010028409A1 (en)

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EP2330995B1 (en) 2015-08-05
EP2330995A1 (en) 2011-06-15
CA2736221C (en) 2016-01-05
CA2736221A1 (en) 2010-03-11
ES2551324T3 (en) 2015-11-18
US20150018810A1 (en) 2015-01-15
WO2010028409A1 (en) 2010-03-11
EP2330995A4 (en) 2013-03-06
US20110152849A1 (en) 2011-06-23
US8784409B2 (en) 2014-07-22

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