CA2314352A1 - Apparatus and method for cryogenic inhibition of hyperplasia - Google Patents

Apparatus and method for cryogenic inhibition of hyperplasia Download PDF

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Publication number
CA2314352A1
CA2314352A1 CA002314352A CA2314352A CA2314352A1 CA 2314352 A1 CA2314352 A1 CA 2314352A1 CA 002314352 A CA002314352 A CA 002314352A CA 2314352 A CA2314352 A CA 2314352A CA 2314352 A1 CA2314352 A1 CA 2314352A1
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CA
Canada
Prior art keywords
balloon
catheter
cryosurgical
lumen
wall
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Legal status (The legal status 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 status listed.)
Granted
Application number
CA002314352A
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French (fr)
Other versions
CA2314352C (en
Inventor
James Joye
Ronald Williams
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ODYSSEY TECHNOLOGIES Inc
Original Assignee
Odyssey Technologies, Inc.
James Joye
Ronald Williams
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Publication of CA2314352A1 publication Critical patent/CA2314352A1/en
Application granted granted Critical
Publication of CA2314352C publication Critical patent/CA2314352C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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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
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22001—Angioplasty, e.g. PCTA
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22001—Angioplasty, e.g. PCTA
    • A61B2017/22002—Angioplasty, e.g. PCTA preventing restenosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • 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
    • A61B2018/00184—Moving parts
    • A61B2018/00196—Moving parts reciprocating lengthwise
    • 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
    • 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
    • A61B2018/0275—Characteristics of handpieces or probes using a circulating cryogenic fluid with restriction of flow using porous elements

Abstract

Post angio-plasty hyperplasia in blood vessels is treated using a cryosurgical balloon catheter (10). The balloon catheter is positioned at a target region within the blood vessel, and the balloon (18) inflated by expanding a cryogenic fluid, such as liquid nitrogen, across an expansion orifice into a balloon. The balloon will be constructed so that cooling is achieved primarily in the central regions of the balloon, with the proximal, and distal regions being less cold, and acting to insulate adjacent regions of the blood vessel from excessive cooling.

Claims (44)

1. A cryosurgical catheter comprising:
a catheter body having a proximal end, a distal end, and a primary lumen therethrough, said lumen having a Joule-Thomson orifice near its distal end;
and a balloon disposed at the distal end of the catheter body over the Joule-Thomson orifice.
2. A cryosurgical catheter as in claim 1, wherein the balloon has a length of at least 1 cm and the orifice is positioned at least 0.5 cm from each end.
3. A cryosurgical catheter as in claim 1, further comprising a containment bladder nested inside the balloon, wherein the containment bladder is disposed over the orifice and each end of the containment bladder is spaced axially inwardly from the respective end of the balloon by at least 0.25 cm.
4. A cryosurgical catheter as in claim 3, further comprising a balloon inflation lumen in the catheter body, wherein the balloon receives an inflation medium from the inflation lumen and the containment bladder receives an expanded gas from the primary lumen.
5. A cryosurgical catheter as in claim 1, wherein the primary lumen is insulated.
6. A cryosurgical catheter as in claim 5, wherein the insulation comprises a coaxial sleeve.
7. A method for treating hyperplasia or neoplasia in a body lumen, said method comprising:
cooling an inner surface of the body lumen to a temperature and for a time sufficient to inhibit subsequent cell growth.
8. A method as in claim 7, wherein the body lumen is an artery subject to hyperplasia resulting from treatment of a stenosis.
9. A method as in claim 8, wherein the treatment comprised balloon angioplasty.
10. A method as in claim 8, wherein the cooling step is performed within one hour following treatment of the stenosis.
11. A method as in claim 7, wherein the cooling step comprises lowering the temperature of the lumenal surface to from 0°C to -80°C for a time period in the range from 1 second to 10 seconds.
12. A method as in claim 7, wherein the cooling step comprises:
introducing a catheter into the body lumen;
positioning a balloon on the catheter proximate a target site on the inner surface;
expanding a gas within the balloon to cryogenically cool the target site.
13. A method as in claim 12, wherein the expanding step comprises flowing liquid nitrogen to a Joule-Thomson orifice positioned within the balloon so that the nitrogen expands across the orifice.
14. A method as in claim 13, wherein the pressure within the balloon is maintained at from 30 psi to 100 psi and the temperature near the orifice is in the range from -40°C to -100°C.
15. A method as in claim 14, wherein the temperature at each end of the balloon is above 0°C.
16. A method as in claim 12, wherein the balloon has a length of at least 1 cm and the orifice is positioned at least 0.5 cm from each end.
17. A method as in claim 12, wherein the balloon dimensions and the gas expansion conditions are selected to produce a temperature profile over the length of the balloon with a temperature between the ends below 0°C and temperatures at each end above 0°C.
18. A method as in claim 7, wherein the cooling step comprises:
introducing a catheter body into the body lumen;
positioning a balloon on the catheter proximate a target site on the inner surface;
vaporizing a liquid within the balloon to cryogenically cool the target site.
19. A method as in claim 12, further comprising measuring a temperature of the target site with a thermocouple mounted outside the balloon and controlling the gas expansion based on the measured temperature.
20. A cryosurgical system comprising:
a flexible catheter body having a proximal end, a distal end, and a gas exhaust lumen defining an axis therebetween;
an intravascular balloon disposed near the distal end of the catheter body in fluid communication with the exhaust lumen, the balloon expandable to radially engage a surrounding vessel wall;
a cryogenic cooling fluid supply; and at least one port disposed within the balloon and in fluid communication with the cooling fluid supply.
21. The cryosurgical system of claim 20, wherein the cryogenic cooling fluid supply comprises a flexible cooling fluid supply tube having a primary lumen, the flexible tube being disposed within the exhaust lumen of the catheter body.
22. The cryosurgical system of claim 21, wherein the at least one port comprises at least one Joule-Thompson orifice.
23. The cryosurgical system of claim 21, wherein the at least one port releases cryogenic cooling fluid from the cooling fluid supply into the balloon at least in part as a liquid so that enthalpy of vaporization of the liquid cools the balloon wall.
24. The cryosurgical system of claim 23, wherein gas from the vaporization of the cooling fluid inflates the balloon to a pressure below a maximum safe balloon pressure, the exhaust lumen transmitting the gas from the blood vessel.
25. The cryosurgical catheter for use in a blood vessel having a vessel wall, the cryosurgical catheter comprising:
a flexible catheter body having a proximal end, a distal end, and a gas exhaust lumen defining an axis therebetween;
a balloon disposed at the distal end of the catheter body in fluid communication with the exhaust lumen, the balloon having a balloon wall with proximal and distal ends and a radially oriented region extending therebetween, the wall being radially expandable to engage the surrounding vessel wall;
a cryogenic cooling fluid supply; and at least one cooling fluid distribution port in communication with the fluid supply and disposed within the balloon to cool the region of the expanded balloon wall.
26. The cryosurgical catheter of claim 25, wherein the at least one cooling distribution port is positioned within the balloon so as to cool the region of the expanded balloon wall to a lower temperature than the distal end of the balloon wall.
27. The cryosurgical catheter of claim 25, wherein the region of the balloon wall defines an elongate cylinder separating the proximal and distal ends, and wherein the exhaust gas lumen extends distally of the proximal end of the balloon wall so as to inhibit cooling of the proximal end of the balloon wall such that the proximal end of the balloon wall remains at a higher temperature than the region of the balloon wall.
28. A cryosurgical catheter for use in a blood vessel having a vessel wall, the cryosurgical catheter comprising:
a flexible catheter body having a proximal end, a distal end, and a lumen defining an axis therebetween;
a balloon disposed at the distal end of the catheter body in fluid communication with the lumen, the balloon having a balloon wall that expands radially to engage the surrounding vessel wall;

a plurality of cooling fluid distribution ports in communication with a cooling fluid supply, the fluid ports distributed within the balloon so a's to evenly cool a portion of the vessel wall.
29. The cryosurgical catheter of claim 28, wherein the ports are separated circumferentially within the balloon.
30. The cryosurgical catheter of claim 29, wherein the ports are radially oriented.
31. The cryosurgical catheter of claim 30, wherein the ports are mounted on a diffuser head at a distal end of a cooling fluid supply tube, and wherein the diffuser head moves axially within the balloon between a first position and a second position when the fluid supply tube moves axially within the catheter body.
32. The cryosurgical catheter of claim 31, wherein the diffuser head is disposed within a housing when the orifice head is in the first position, and wherein the ports are clear of the housing when the orifice head is disposed in the second position.
33. The cryosurgical catheter of claim 32, wherein the diffuser head has an axial channel, and further comprising a support slidably disposed within the channel of the diffuser head, the axial support extending from a proximal end of the balloon to a distal end of the balloon.
34. The cryosurgical catheter of claim 28, wherein the ports are distributed axially within the balloon.
35. The cryosurgical catheter of claim 34, wherein the ports are defined by a porous tubular structure disposed within the balloon, the ports being distributed axially and circumferentially over the porous tubular structure.
36. A cryosurgical catheter for use in a blood vessel having a vessel wall, the cryosurgical catheter comprising:
a flexible catheter body having a proximal end, a distal end, and a lumen defining an axis therebetween;

an axially elongate balloon disposed at the distal end of the catheter body in fluid communication with the lumen, the balloon having a balloon wall that can expand radially to engage the surrounding vessel wall;
a diffuser head having at least one port in fluid communication with a cooling fluid supply, the diffuser head movable axially within the balloon between a first position and a second position.
37. A method for treating a blood vessel having a vessel wall, the method comprising:
introducing a catheter into the blood vessel;
expanding a balloon of the catheter near a target site to engage the vessel wall;
expanding fluid at a first location within the balloon; and expanding fluid at a second location within the balloon to cryogenically cool at least a portion of the engaged vessel wall, the second location being separated from the first location.
38. The method of claim 37, further comprising moving a diffuser head between the first location and the second location.
39. The method of claim 38, wherein a housing separates the balloon and the vessel wall when the orifice head is at the first location, wherein fluid expansion is initiated at the first location, and wherein the moving step moves ports of the diffuser head from within the housing after a reduction in thermal transients of the gas expansion.
40. The method of claim 37, wherein fluid expansion occurs simultaneously at the first and second locations, the balloon being axially elongate, the first and second locations being separated axially.
41. The method of claim 37, wherein the fluid expansion occurs simultaneously at the first and second locations so that the fluid flows radially toward the vessel wall, the first and second locations being separated circumferentially.
42. The method of claim 37, wherein the first and second expansion steps comprise vaporization of at least a portion of the fluid from a liquid to a gas so that the enthalpy of vaporization cools the at least a portion of the engaged vessel wall.
43. The method of claim 37, wherein the first and second expansion steps are effected by passing the fluid through at least one Joule-Thompson orifice.
44. A kit for treating hyperplasia or neoplasia in a body lumen, the kit comprising:
a catheter having a proximal end, a distal end, and balloon near its distal end; and instructions for use of the catheter, said instructions comprising the step of cooling an inner surface of the body lumen with the balloon to a temperature and for a time sufficient to inhibit subsequent cell growth.
CA2314352A 1997-12-02 1998-12-01 Apparatus and method for cryogenic inhibition of hyperplasia Expired - Fee Related CA2314352C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US08/982,824 1997-12-02
US08/982,824 US5971979A (en) 1997-12-02 1997-12-02 Method for cryogenic inhibition of hyperplasia
PCT/US1998/025448 WO1999027862A1 (en) 1997-12-02 1998-12-01 Apparatus and method for cryogenic inhibition of hyperplasia

Publications (2)

Publication Number Publication Date
CA2314352A1 true CA2314352A1 (en) 1999-06-10
CA2314352C CA2314352C (en) 2010-05-04

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CA2314352A Expired - Fee Related CA2314352C (en) 1997-12-02 1998-12-01 Apparatus and method for cryogenic inhibition of hyperplasia

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US (4) US5971979A (en)
EP (1) EP1039838B1 (en)
JP (1) JP2001524345A (en)
AU (1) AU744106B2 (en)
CA (1) CA2314352C (en)
DE (1) DE69831172T2 (en)
WO (1) WO1999027862A1 (en)

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