WO2002000128B1 - Cryotreatment device and method - Google Patents

Cryotreatment device and method

Info

Publication number
WO2002000128B1
WO2002000128B1 PCT/US2001/019998 US0119998W WO0200128B1 WO 2002000128 B1 WO2002000128 B1 WO 2002000128B1 US 0119998 W US0119998 W US 0119998W WO 0200128 B1 WO0200128 B1 WO 0200128B1
Authority
WO
WIPO (PCT)
Prior art keywords
lumen
fluid
inflation
end portion
expandable
Prior art date
Application number
PCT/US2001/019998
Other languages
French (fr)
Other versions
WO2002000128A2 (en
WO2002000128A3 (en
Inventor
Sean Carroll
Dan Wittenberger
Claudia Lueckge
Original Assignee
Cryocath Technologies Inc
Sean Carroll
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 Cryocath Technologies Inc, Sean Carroll filed Critical Cryocath Technologies Inc
Priority to AT01948630T priority Critical patent/ATE308933T1/en
Priority to DE60114832T priority patent/DE60114832T2/en
Priority to EP01948630A priority patent/EP1301133B1/en
Priority to CA002413529A priority patent/CA2413529C/en
Publication of WO2002000128A2 publication Critical patent/WO2002000128A2/en
Publication of WO2002000128A3 publication Critical patent/WO2002000128A3/en
Publication of WO2002000128B1 publication Critical patent/WO2002000128B1/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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • 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

Abstract

A medical device for cryotreatment of bodily regions is disclosed. The device comprises an inflatable support structure coupled to the distal end portion of a catheter shaft, the support structure being further enveloped by an expandable membrane to define an expansion chamber between the support structure and the membrane. An inflation lumen is coupled to the support structure to inject an inert, insulating fluid in the support structure, thereby expanding the support structure and the expandable membrane, wherein the resultant expansion chamber formed therebetween is substantially conical in shape. Refrigerant is injected into the expansion chamber, thereby creating localized cooling of tissues adjacent to the expansion chamber, the cooling region being substantially conical in shape. Alternately, a second inflatable support structure is provided inside of the expandable membrane and distal to the first support structure, to define an expansion chamber therebetween that is substantially toroidal in shape, thereby enabling the creation of circumferential cooling regions when refrigerant is injected into said expansion chamber.

Claims

AMENDED CLAIMS[received by the International Bureau on 27 May 2002 (27.05.02); original claims 1, 9 and 28 amended; remaining claims unchanged (11 pages)]
1. A medical device comprising: a first support structure transitionable from a first state to a second state; and an expandable membrane enveloping the first support structure to define an expansion chamber when the support structure is in the second state, the expansion chamber being configured to receive a refrigerant to thereby reduce the temperature of the expandable element to effect cryogenic therapy .
2. The device according to claim 1 , wherein the expansion chamber is substantially conical in shape.
3. The device according to claim 1, further comprising a second support structure transitionable from a first state to a second state, the expandable membrane enveloping both the first and second support structure such that the expansion chamber is defined between the first and second support structures when such support structures are in their respective second states.
4. The device according to claim 3, wherein the expansion chamber is substantially toroidal in shape.
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5. The device according to claim 1 , wherein the first support structure is continuously fransitionable between the first and second state, to define a continuously fransitionable expansion chamber, the expansion chamber having a minimum and maximum volume when the support structure is in its first and second states, respectively.
6. The device according to claim 1, wherein the device is coupled to and integrated into a deflectable catheter system.
7. The device according to claim 1, wherein the device is coupled to and integrated into an over-the-wire catheter system.
8. The device according to claim 1, wherein the device is coupled to and integrated into a rapid exchange catheter system.
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9. A medical device comprising: an elongate shaft having proximal and distal end portions, the shaft defining or containing an injection lumen, an exhaust lumen, and an inflation lumen therethrough, each lumen having a proximal end portion and distal end portion proximate the proximal and distal end portions of the shaft, respectively, a first expandable membrane coupled to the distal end portion of the shaft, having an inner surface and an outer surface, the inner surface being in fluid communication with the distal end portion of the inflation lumen to define an inflation chamber inside of the membrane, a second expandable membrane having an inner surface and an outer surface, the inner surface being in fluid communication with the distal end portions of the injection and exhaust lumens, the second membrane being disposed around the first membrane to define an expansion chamber therebetween, the expansion chamber being configured to receive a refrigerant to thereby reduce the temperature of the second expandable membrane
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10. The device according to claim 9, further comprising: a supply of cryogenic fluid in fluid communication with the proximal end portion of the injection lumen, wherein the injection lumen, expansion chamber, and exhaust lumen define a fluid path for the flow of cryogenic fluid therethrough, and a supply of inflation fluid in fluid communication with the proximal end portion of the inflation lumen, wherein the inflation lumen and inflation chamber define a fluid path for the flow of inflation fluid therethrough.
11. The device according to claim 9, wherein the first expandable membrane is filled with inflation fluid, the inflation fluid being in contact with the inner surface of the first expandable membrane.
12. The device according to claim 11 , wherein the second expandable membrane is filled with cryogenic fluid, the cryogenic fluid being in contact with the outer surface of the first expandable membrane and the inner surface of the second expandable membrane.
13. The device according to claim 9, wherein the first expandable membrane is transitionable from a first geometric shape to a second geometric shape, to define a first geometric shape and a second geometric shape, respectively, of the expansion chamber.
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14. The device according to claim 13, wherein the second geometric shape of the first expandable membrane is substantially cylindrical, such that the second geometric shape of the expansion chamber is substantially a frustum of aright circular cone, the expansion chamber being distal to the first expandable membrane, the first expandable membrane and the expansion chamber each sharing an axis of radial symmetry parallel to the distal end portion of the elongate shaft.
15. The device according to claim 10, wherein the cryogenic fluid is nitrous oxide.
16. The device according to claim 10, wherein the inflation fluid is saline solution.
17. The device according to claim 10, wherein the cryogenic fluid is nitrogen.
18. The device according to claim 9, further comprising: a supply of cryogenic fluid in fluid communication with the proximal end portion of the injection lumen, wherein the injection lumen, expansion chamber, and exhaust lumen define a fluid path for the flow of cryogenic fluid therethrough, and a vacuum lumen defined or contained in the shaft, the vacuum lumen being in fluid communication with the inflation chamber, the supply of cryogenic fluid being in fluid communication with the inflation and vacuum lumens, wherein the inflation lumen, inflation chamber and vacuum lumen define a fluid path for the flow of cryogenic fluid therethrough.
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19. A medical device comprising: a shaft having proximal and distal end portions, a first expandable membrane coupled to the distal end portion of the shaft, a second expandable membrane coupled to the distal end portion of the shaft, the second expandable membrane being distal to the first expandable membrane, a third expandable membrane coupled to the distal end portion of the shaft, and disposed around the first and second expandable membranes.
20. The device according to claim 19, wherein the first and second expandable membranes are each fransitionable between a first geometric state and a second geometric state, respectively, to collectively define an expansion chamber inside of the third expandable membrane and outside both of the first and second expandable membranes, the first geometric state for each of the first and second expandable membranes having a volume that is substantially lower than the volume of the second geometric state of each of the first and second expandable membranes, respectively, the second geometric state of each of the first and second expandable membranes being generally cylindrical, having an axis of radial symmetry generally parallel to the distal end portion of the elongate shaft.
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40
21. The device according to claim 20, wherein the expansion chamber defines a toroid having: an axis of radial symmetry generally parallel to the distal end portion of the elongate shaft, a surface defined by a plane closed curve rotated 360 degrees about the axis of radial symmetry, the expansion chamber being disposed between the first expandable membrane in its second geometric state and the second expandable membrane in its second geometric state.
22. The device according to claim 21 , wherein the toroid has a surface defined by a plane closed curve rotated 360 degrees about the axis of radial symmetry, the plane closed curve being substantially a rectangle.
23. The device according to claim 21 , wherein the toroid has a surface defined by a plane closed curve rotated 360 degrees about the axis of radial symmetry, the plane closed curve being substantially a frapezoid.
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41
24. The device according to claim 19, the shaft further including: at least one inflation lumen and at least one deflation lumen, each having: a proximal end portion proximate the proximal end portion of the elongate shaft, and a distal end portion proximate the distal end portion of the shaft; an injection lumen having: a proximal end portion proximate the proximal end portion of the elongate shaft, and a distal end portion proximate the distal end portion of the shaft; an exhaust lumen having: a proximal end portion proximate the proximal end portion of the elongate shaft, and a distal end portion proximate the distal end portion of the shaft.
25. The device according to claim 24, wherein the first and second expandable membranes are in fluid communication with the distal end portions of the at least one inflation and deflation lumens, respectively; and wherein the third expandable membrane is in fluid communication with the distal end portions of the injection and exhaust lumens, respectively.
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42
26. The device according to claim 25, further comprising: a supply of cryogenic fluid in fluid communication with the proximal end portion of the injection lumen, wherein the injection lumen, expansion chamber, and exhaust lumen define a fluid path for the flow of cryogenic fluid therethrough, and a supply of inflation fluid in fluid communication with the proximal end portion of the inflation lumen, wherein the inflation lumen and inflation chamber define a fluid path for the flow of inflation fluid therethrough.
27. The device according to claim 25, further comprising: a supply of cryogenic fluid, the supply of cryogenic fluid being in fluid communication with the proximal end portion of the injection lumen, wherein the injection lumen, expansion chamber, and exhaust lumen define a fluid path for the flow of cryogenic fluid therethrough, and the supply of cryogenic fluid being in fluid communication with each of the at least one inflation and deflation lumens, respectively, wherein the each of the at least one inflation lumen, the first and second expandable membranes, and the at least one deflation lumen define a fluid path for the flow of cryogenic fluid therethrough.
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28. A method for cooling a cryogenic medical device, including the steps of: a) providing a supply of cryogenic fluid and a supply of inflation fluid; b) fluidly connecting said supply of cryogenic fluid and inflation fluid with a catheter having an injection lumen, an exhaust lumen, and an inflation lumen therein, the catheter having proximal and distal ends, the catheter having an expandable support structure coupled to the distal end in fluid communication with the inflation lumen, and an expandable membrane coupled to the distal end, the expandable membrane enveloping the support structure to define an expansion chamber therebetween, the expansion chamber being configured to receive a refrigerant to thereby reduce the temperature of the expandable membrane; c) providing a flow regulation system to dispense cryogenic fluid into the injection lumen and out from exhaust lumen, and to dispense inflation fluid into and out of the inflation lumen; d) confroUably inj ecting the supply of inflation fluid into the inflation lumen, the inflation fluid inflating the expandable support structure from a first geometric state to a second geometric state; e) confroUably injecting the supply of cryogenic fluid into the injection lumen, to dispense the cryogenic fluid into the membrane; f) confroUably evacuating the cryogenic fluid from the membrane.
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29. A method for cooling a cryogenic medical device, including the steps of: a) providing a supply of cryogenic fluid; b) fluidly connecting said supply of cryogenic fluid with a catheter containing an injection lumen, an exhaust lumen, and a vacuum lumen therein, the catheter and lumens having corresponding proximal and distal ends, the catheter having an expandable support structure coupled to its distal end in fluid communication with the injection lumen and exhaust lumen, and having an expandable membrane coupled to the distal end, the expandable membrane enveloping the support structure to define an expansion chamber therebetween, the expandable membrane being fluid communication with the vacuum lumen; c) providing a flow regulation system to dispense cryogenic fluid into the injection lumen to inflate the expandable support structure from a first geometric state to a second geometric state; d) providing a flow regulation system to maintain vacuum pressure in the expansion chamber inside of the expandable membrane; e) confroUably evacuating the cryogenic fluid from the expandable support structure through the exhaust lumen.
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PCT/US2001/019998 2000-06-23 2001-06-22 Cryotreatment device and method WO2002000128A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
AT01948630T ATE308933T1 (en) 2000-06-23 2001-06-22 DEVICE FOR CRYOTREATMENT
DE60114832T DE60114832T2 (en) 2000-06-23 2001-06-22 DEVICE FOR CYCLING
EP01948630A EP1301133B1 (en) 2000-06-23 2001-06-22 Cryotreatment device
CA002413529A CA2413529C (en) 2000-06-23 2001-06-22 Cryotreatment device and method

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US21379300P 2000-06-23 2000-06-23
US60/213,793 2000-06-23
US09/887,536 US6595988B2 (en) 2000-06-23 2001-06-22 Cryotreatment device and method
US09/887,536 2001-06-22

Publications (3)

Publication Number Publication Date
WO2002000128A2 WO2002000128A2 (en) 2002-01-03
WO2002000128A3 WO2002000128A3 (en) 2002-06-06
WO2002000128B1 true WO2002000128B1 (en) 2002-11-14

Family

ID=26908401

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2001/019998 WO2002000128A2 (en) 2000-06-23 2001-06-22 Cryotreatment device and method

Country Status (6)

Country Link
US (1) US6595988B2 (en)
EP (1) EP1301133B1 (en)
AT (1) ATE308933T1 (en)
CA (1) CA2413529C (en)
DE (1) DE60114832T2 (en)
WO (1) WO2002000128A2 (en)

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WO2002000128A2 (en) 2002-01-03
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EP1301133B1 (en) 2005-11-09
WO2002000128A3 (en) 2002-06-06
CA2413529C (en) 2008-12-02
CA2413529A1 (en) 2002-01-03
DE60114832D1 (en) 2005-12-15
US20020007180A1 (en) 2002-01-17
ATE308933T1 (en) 2005-11-15
US6595988B2 (en) 2003-07-22

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