CA2290635A1 - Method and apparatus for cryogenic spray ablation of gastrointestinal mucosa - Google Patents

Method and apparatus for cryogenic spray ablation of gastrointestinal mucosa Download PDF

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Publication number
CA2290635A1
CA2290635A1 CA002290635A CA2290635A CA2290635A1 CA 2290635 A1 CA2290635 A1 CA 2290635A1 CA 002290635 A CA002290635 A CA 002290635A CA 2290635 A CA2290635 A CA 2290635A CA 2290635 A1 CA2290635 A1 CA 2290635A1
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CA
Canada
Prior art keywords
catheter
endoscope
gas
cryogenic
esophagus
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Granted
Application number
CA002290635A
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French (fr)
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CA2290635C (en
Inventor
Mark H. Johnston
Jennifer B. Cartledge
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Fiber Tech Medical Inc
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Individual
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Application filed by Individual filed Critical Individual
Publication of CA2290635A1 publication Critical patent/CA2290635A1/en
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Publication of CA2290635C publication Critical patent/CA2290635C/en
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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
    • 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
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots
    • A61B34/35—Surgical robots for telesurgery
    • 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
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00269—Type of minimally invasive operation endoscopic mucosal resection EMR
    • 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
    • A61B2017/00973—Surgical instruments, devices or methods, e.g. tourniquets pedal-operated
    • 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
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B50/31—Carrying cases or bags, e.g. doctors' bags
    • A61B2050/311—Cases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/373—Surgical systems with images on a monitor during operation using light, e.g. by using optical scanners

Abstract

This invention is a method and apparatus to treat Barrett's tissue, a precancerous condition, by removing the epithelium above the lower esophageal sphincter through cryo-ablation. An endoscope (10) with fiber optics is used to view the operation, and a catheter (20) for supplying liquid nitrogen (LG) is passed through the lumen of the endoscope. Liquid nitrogen is sprayed directly onto the Barrett's tissue through the catheter while the physician views the operation through the fiber optics of the endoscope, and controls the spray via a valve. Freezing is indicated by whiteness, and shows that the epithelium has been cryo-ablated. The apparatus can also be used to various other gastrointestinal tract lesions. A most important and significant feature of this invention is the fact that the liquid nitrogen spray is applied in the esophagus at low pressure.

Claims (47)

1. A cryosurgical apparatus useful for cryogenic spray ablation comprising in combination an endoscope, a catheter and a source of liquified gas attached to said catheter such that the endoscope aids in placing a cryogenic gas to be sprayed in proximity to the area to be cryogenically ablated and with the catheter being able to produce low pressure delivery of cryogen without perforating the esophagus.
2. The cryosurgical apparatus of claim 1 further comprising a fiber optic means for viewing he area to be ablated.
3. The cryosurgical apparatus of claim 2 wherein the fiber optic means is disposed together with illuminating light and imaging camera.
4. The cryosurgical apparatus of claim 1 wherein the imaging camera has a lens along with a means for defogging the lens of said imaging camera.
5. The cryosurgical apparatus of claim 1 further comprising an inflatable means capable of inflating and thereby localizing a cryogenic gas in the area to be ablated.
6. The cryosurgical apparatus of claim 1 wherein the catheter has a distal end and a proximal end with the distal end being provided with means to spray the cryogenic gas in a radial direction relative to the axis of the catheter.
7. The cryosurgical apparatus of claim 1 provided with means for controlling the supply of liquified gas.
8. The cryosurgical apparatus of claim 1 wherein a heating device is attached to said source of liquified gas to aid in the efficient delivery of said gas for ablation.
9. The cryosurgical apparatus of claim 1 wherein the instrument is provided with a means for purging moist air or gas from the esophagus.
10. The cryosurgical apparatus of claim 1 wherein the catheter is provided at its proximal end with a bleeder vent to reduce the pressure of gas supplied at the distal end of the catheter.
11. A method for treating Barrett's esophagus comprising applying a cryogenic gas to the affected area of the esophagus employing the cryosurgical instrument of claim 1 and thereby ablating the diseased tissue of Barrett's esophagus.
12. An apparatus for cryogenic spray ablation of intralumenal mucosa, comprising:
an endoscope having an imaging camera lens and illuminating light at the distal end thereof and at least one additional lumen therethrough;
a catheter extending through a lumen of said endoscope, said catheter extending from the proximal end of said endoscope and terminating at means for causing fluid flowing therethrough to be sprayed in a radial direction substantially perpendicular to the axis of said catheter;
a source of liquified gas connected to the portion of said catheter extending from the proximal end of said endoscope; and means for controlling the flow of liquified gas from said source to said catheter.
13. An apparatus in accordance with claim 12, further including means for withdrawing gas from an area distal to said endoscope to an area proximal to said endoscope.
14. An apparatus in accordance with claim 12, wherein said means for controlling comprises a valve which can be opened to permit flow of liquified gas to said catheter or closed to prevent flow of liquified gas to said catheter.
15. An apparatus in accordance with claim 12, further including means for blocking the lumen containing the mucosa to be sprayed, when the apparatus is in use, at a locus distal to the locus of intended cryogenic spray ablation.
16. An apparatus in accordance with claim 12, wherein said means for blocking comprises a balloon catheter, whereby the lumen is blocked when the balloon of said balloon catheter is inflated.
17. An apparatus in accordance with claim 12, wherein said endoscope is a diagnostic endoscope having a single said additional lumen therethrough and wherein said catheter extends through said single additional lumen.
18. An apparatus in accordance with claim 12, wherein said endoscope is a therapeutic endoscope having two additional lumens extending therethrough.
19. An apparatus in accordance with claim 12, wherein said source of liquified gas comprises a container of liquified gas and means for forcing said liquified gas under pressure to said means for controlling the flow of liquified gas.
20. An apparatus in accordance with claim 12, wherein said gas is nitrogen.
21. A kit containing paraphernalia for use in cryogenic spray ablation of intralumenal mucosa, comprising:
a container having packaged therein:
1) a catheter having at one end means for causing any fluid flowing therethrough to be sprayed in a radial direction substantially perpendicular to the axis of said catheter;
2) means for connecting said catheter to a source of liquid gas; and 3) bleeder vent means for controlling the pressure of the flow of liquified gas to the tip of said catheter.
22. A kit in accordance with claim 21, wherein said container further contains:
a tube and means connectable to said tube for withdrawing gas from said tube.
23. A kit in accordance with claim 21, wherein said container further contains:
means for blocking the lumen containing the mucosa to be sprayed when the paraphernalia is in use.
24. A method for cryogenic spray ablation of intralumenal mucosa using the apparatus of claim 11, comprising:
inserting said endoscope into the esophagus containing the intralumenal mucosa to be sprayed;
adjusting said catheter to place said means for causing radial fluid spray to be disposed adjacent the mucosa to be sprayed;
opening said means for controlling the flow of liquefied gas to allow liquefied gas to flow from said source to said catheter;
observing the spray of liquefied gas; and closing said means for controlling the flow of liquefied gas once the mucosa appears to be frozen.
25. The method of claim 24 wherein the esophagus is vented prior to allowing the liquified gas to flow.
26. A method in accordance with claim 24, further including the step of withdrawing gas from an area of the lumen containing the mucosa being sprayed distal to said spray locus, during the time that said means for controlling the flow of gas is open.
27. A method in accordance with claim 24, further including the step of blocking the lumen containing controlling is open, whereby the gas into which the liquified gas evaporates during use is prevented from passing beyond the blockage.
28. A method in accordance with claim 24, wherein said catheter has a degree of insulation which permits at least five seconds to pass from the time said means for controlling the flow of gas is opened to the time that liquified gas is sprayed onto the mucosa.
29. A method in accordance with claim 24, wherein the intralumenal mucosa being sprayed is the Barrett's tissue in the esophagus of a patient with Barrett's esophagus.
30. An apparatus for the cryogen ablation of precancerous lesions within a Barrett's esophagus of a patient, comprising an endoscope having a distal end provided with a lens, such that the endoscope may be used to locate the precancerous lesions, a catheter connected to the endoscope and carried thereby, and a source of a cryogen connected to the catheter and disposed externally of the patient, such that the flow of the cryogen may be controlled for the selective ablation of the precancerous lesions located via the lens on the endoscope, and such that the moist air normally found within the esophagus may be purged, thereby substantially reducing condensation on the lens of the endoscope, thereby substantially eliminating any haze on the lens, and thereby obtaining clear views of the tissues of the esophagus.
31. A method for the cryogen ablation of precancerous lesions within a Barrett's esophagus of a patient, comprising the steps of applying liquid nitrogen or nitrogen gas to the precancerous lesions for a min. to max. p.s.i. of approximately 3-5 p.s.i.
32. A method for treating an internal lesion of the intestinal tract comprising applying a cryogenic gas to said lesion with the cryosurgical apparatus of claim 1 and thereby ablating said lesion.
33. A catheter device for use in cryogenic surgery comprising a connector and a gas bleeding vent with said gas bleeding vent being positioned between the connector and the proximal end of the catheter and, when the connector is attached to a cryogenic gas supply, the distal end of the catheter is able to supply low pressure cryogen.
34. The device of claim 33 packaged in a kit.
35. The device of claim 33 packaged in a kit, with said kit further containing a nasogastric tube.
36. In an apparatus for the treatment of Barrett's disease in the esophagus of a patient, wherein a cryogenic spray is applied to pre-cancerous lesions within the patient's esophagus, an insulated catheter connected to a cryogenic source externally of the patient and carried by an endoscope inserted into the patient's esophagus, such that the catheter may withstand extremely cold temperatures without becoming stiff and without affecting the inherent flexibility and maneuverability of the endoscope.
37. The insulated catheter of claim 36, wherein the insulated catheter is capable of withstanding temperatures down to -100° C.
38. The insulated catheter of claim 37, wherein the insulated catheter has a tip through which the cryogenic spray is discharged, the temperature at the tip of the insulated catheter being approximately -20°C.
39. An insulated catheter intended to be connected to a cryogenic source and carried by an endoscope inserted within a patient's esophagus for selectively delivering a cryogenic spray for the treatment of Barrett's disease.
40. The insulated catheter of claim 39, wherein the insulated catheter is capable of withstanding temperatures down to -100° C, such that the catheter will not become stiff, thereby assuring that there will be no substantial effect on the flexibility and maneuverability of the endoscope.
41. A cryogenic apparatus for the treatment of Barrett's disease within the esophagus of a patient, comprising a cryogenic source, an endoscope intended to be inserted within the patient's esophagus, a catheter carried by the endoscope and connected to the cryogenic source, and a foot-pedal controlled solenoid-actuated valve between the catheter and the cryogenic source.
42. A cryogenic apparatus for the treatment of Barrett's disease within the esophagus of a patient, comprising a cryogenic source, an endoscope intended to be inserted within the patient's esophagus, a catheter carried by the endoscope and connected to the cryogenic source, the catheter having a tip through which a cryogenic spray is applied to pre-cancerous lesions within the patient's esophagus, and an electronically-controlled timer provided with a display indicating the time interval that the cryogenic spray has been discharged from the tip of the catheter.
43. The cryogenic apparatus of claim 42, wherein the electronically-controlled timer includes a print-out of the time interval.
44. The cryogenic apparatus of claim 43, wherein the print-out is patient specific.
45. A pressurized tank containing liquid nitrogen wherein the pressurized tank is intended to be connected to a catheter carried by an endoscope and inserted within a patient's esophagus for the treatment of Barrett's disease, wherein a cryogenic spray is discharged from the tip of the catheter and applied to pre-cancerous lesions within the patient's esophagus, and wherein the pressurized tank is provided with a bleed-off to assure that the pressure of the cryogenic spray being discharged from the tip of the catheter does not inadvertently injure the patient.
46. The pressurized tank of claim 45, wherein the pressure of the cryogenic spray at the tip of the catheter is less than 3 atmospheres.
47. A method of treating internal lesions of the intestinal tract comprising applying to such lesions a low pressure cryogenic spray to ablate said lesions.
CA002290635A 1997-05-23 1998-04-15 Method and apparatus for cryogenic spray ablation of gastrointestinal mucosa Expired - Lifetime CA2290635C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US4748497P 1997-05-23 1997-05-23
US60/047,484 1997-05-23
US09/050,150 US6027499A (en) 1997-05-23 1998-03-30 Method and apparatus for cryogenic spray ablation of gastrointestinal mucosa
US09/050,150 1998-03-30
PCT/US1998/007541 WO1998052479A1 (en) 1997-05-23 1998-04-15 Method and apparatus for cryogenic spray ablation of gastrointestinal mucosa

Publications (2)

Publication Number Publication Date
CA2290635A1 true CA2290635A1 (en) 1998-11-26
CA2290635C CA2290635C (en) 2009-12-15

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CA002290635A Expired - Lifetime CA2290635C (en) 1997-05-23 1998-04-15 Method and apparatus for cryogenic spray ablation of gastrointestinal mucosa

Country Status (10)

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US (2) US6027499A (en)
EP (1) EP0987989B1 (en)
AT (1) ATE331477T1 (en)
AU (1) AU7118398A (en)
CA (1) CA2290635C (en)
DE (1) DE69835084T2 (en)
DK (1) DK0987989T3 (en)
ES (1) ES2273416T3 (en)
PT (1) PT987989E (en)
WO (1) WO1998052479A1 (en)

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