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WO1997018851A1 - Matiere hemostatique et appareil d'hemostase - Google Patents

Matiere hemostatique et appareil d'hemostase Download PDF

Info

Publication number
WO1997018851A1
WO1997018851A1 PCT/US1996/018747 US9618747W WO9718851A1 WO 1997018851 A1 WO1997018851 A1 WO 1997018851A1 US 9618747 W US9618747 W US 9618747W WO 9718851 A1 WO9718851 A1 WO 9718851A1
Authority
WO
WIPO (PCT)
Prior art keywords
hemostasis
ultrasound
reducing agent
bleeding
ultrasound energy
Prior art date
Application number
PCT/US1996/018747
Other languages
English (en)
Inventor
Katsuro Tachibana
Shunro Tachibana
Original Assignee
Ekos Corporation
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 Ekos Corporation filed Critical Ekos Corporation
Priority to JP09519913A priority Critical patent/JP2000507201A/ja
Priority to AU10810/97A priority patent/AU1081097A/en
Priority to EP96940850A priority patent/EP0869828A1/fr
Publication of WO1997018851A1 publication Critical patent/WO1997018851A1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00Ultrasound therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0092Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B2017/12004Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord for haemostasis, for prevention of bleeding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B2017/22005Effects, e.g. on tissue
    • A61B2017/22007Cavitation or pseudocavitation, i.e. creation of gas bubbles generating a secondary shock wave when collapsing
    • A61B2017/22008Cavitation or pseudocavitation, i.e. creation of gas bubbles generating a secondary shock wave when collapsing used or promoted
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22082Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
    • A61B2017/22088Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance ultrasound absorbing, drug activated by ultrasound

Definitions

  • This invention relates generally to hemostasis, and more particularly to a method and apparatus to cause hemostasis using ultrasound and ultrasound sensitive drugs
  • FIGURES Figure 1 is a diagram illustrating the treatment of bleeding when it is difficult to use catheters or endoscopes
  • FIG. 2 is an illustration of an ultrasound therapy generator useful with the present invention
  • Figure 3 illustrates hemostasis treatment with the use of a catheter or endoscope
  • Figure 4 is a cross section view ofthe tip ofthe endoscope of Figure 3
  • An object ofthe invention is to provide a method and apparatus to provide hemostasis without the need for major surgical intervention
  • Another object ofthe invention is to provide a method and apparatus for enhancing phonophoresis
  • a further object ofthe invention is to provide a method and apparatus for enhancing phonophoresis with the introduction of a threshold reducing agent to the body
  • Still another object ofthe invention is to provide a method and apparatus to create hemostasis by introducing a cavitation threshold reducing rate and applying ultrasound energy
  • a method for enhancing phonophoresis A cavitation threshold reducing agent is introduced into the body Ultrasound energy is applied at a selected site in the body at a frequency sufficient to produce a therapeutic effect
  • a method for creating hemostasis includes introducing a cavitation threshold reducing agent to the body Ultrasound energy is applied at a selected site in the body at a frequency sufficient to create hemostasis
  • an apparatus for creating hemostasis includes a cavitation threshold lowering agent means Ultrasound energy means are coupled to the cavitation threshold lowering agent means A sufficient ultrasound energy wavelength is generated to create hemostasis at a selected site in the body.
  • the cavitation threshold lowering agent is Rose Bengal or a hematoporphryn.
  • the present provides a method for enhancing phonophoresis.
  • a cavitation threshold reducing agent is introduced to the body Ultrasound energy is applied at a selected site in the body at a frequency sufficient to produce a therapeutic effect.
  • a method is also provided for creating hemostasis with the introduction ofthe cavitation threshold reducing agent and the application of ultrasound energy
  • the present invention also is an apparatus for creating hemostasis
  • the apparatus includes a cavitation threshold lowering agent means and an ultrasound energy means that is coupled to the cavitation lowering agent means
  • An ultrasound energy wavelength is produced that is sufficient to create hemostasis at the selected site in the body.
  • An apparatus for creating hemostasis includes a hemostasis agent means The apparatus also includes an ultrasound energy means which generates an ultrasound frequency that creates hemostasis at the selected site in the body
  • cavitation threshold reducing drugs or hemostasis drugs can be used. Suitable drugs include but are not limited to Rose Bengal, hematoporphryns, and the like. In one embodiment the amount of delivered ultrasound energy can be in the range of 0.1 to 1000 Watts per square centimeter.
  • the methods and apparatus ofthe invention provide a hemostasis material that effectively and rapidly stop bleeding effectively without performing major surgical intervention such as large scale operations.
  • the methods and apparatus ofthe invention are used to treated a variety of different bleeding sites including but not limited to bleeding by organ rupture hemorrhage within the liver, and the like.
  • ultrasound device 1 can include multiple ultrasound elements lb which are attached to an interior side of a main body portion la of ultrasound device 1
  • An ultrasound vibration element lb can be a plate type ultrasound element which has an electrode on both sides.
  • Ultrasound therapy device 1 is bendable according to the shape ofthe patient A's body This permits ultrasound energy to be concentrated to the bleeding site C.
  • Diagram 3 illustrates a method of therapy where it is possible to use the catheter or endoscopy for stopping bleeding from the organs including but not limited to gastric ulcers, esophageal varices, and the like.
  • FIG 4 shows the cross section view ofthe structure of an endoscope 2 useful with the present invention.
  • the ultrasound sensitive drug is first intravenously injected to the patient
  • an esophageal or gastric endoscope 2 is introduced at bleeding site C in organ B including but not limited to the stomach as shown in Figure 3
  • hemostasis is performed by exposing ultrasound from ultrasound vibrating element 2c.
  • ultrasound vibrating element 2c is attached to the tip ofthe endoscope 2, sheath 2a.
  • the ultrasound sensitive drug in the blood is then activated by ultrasound. This produces instant coagulation which is a more effective hemostasis method than conventional methods.
  • an ultrasound vibrating element 2c is a cylinder piezo electric element in which an optical fiber 2b passes through the center and the electrode is placed on the outer and inner side.
  • the electrode receives electrical signals of ultrasound frequencies which induce ultrasound energy in the direction ofthe arrows.
  • ultrasound vibrating elements 2c are shaped in a cylinder, ultrasound energy is emitted evenly toward the radius ofthe axis of endoscope 2.
  • the shape of ultrasound vibrating element 2c is not limited to illustrated geometry .
  • a disk-like ultrasound vibrating element lb is positioned where optical fiber 2b passes through the center at the tip ofthe sheath 2a ofthe endoscope 2.
  • ultrasound is concentrated at the axis of endoscope 2.
  • the methods and apparatus ofthe present invention provide treatment of bleeding by injecting one or more ultrasound sensitive drugs to the patient along with exposure to ultrasound energy.
  • the methods and apparatus ofthe present invention are particularly useful immediately after bleeding has begun. This permits treatment and stoppage of bleeding can be stopped while the patient is transferred in an ambulance. This decreases the mortality rate of massive bleeding. Death rates from trauma are lowered by temporarily stopping the bleeding. Thereafter, major surgical intervention can be performed at the hospital. Death rates from bleeding are then reduced.
  • the methods and apparatus ofthe present invention are effective for very severe bleeding which is difficult to treat with conventional surgical methods. Additionally, because ultrasound energy can be exposed to a large area, multiple bleeding sites of different origins can be treated at the same time. Ultrasound energy can be exposed exterior to a patient's body for hemostasis.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Medical Informatics (AREA)
  • Anesthesiology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Procédé et appareil destiné à créer une hémostase, consistant à introduire un agent réducteur de seuil de cavitation dans le corps. On applique une énergie à ultrasons au niveau d'un site sélectionné dans le corps, à une fréquence suffisante pour créer une hémostase.
PCT/US1996/018747 1995-11-24 1996-11-22 Matiere hemostatique et appareil d'hemostase WO1997018851A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP09519913A JP2000507201A (ja) 1996-11-22 1996-11-22 止血方法および装置
AU10810/97A AU1081097A (en) 1995-11-24 1996-11-22 Hemostasis material and apparatus
EP96940850A EP0869828A1 (fr) 1995-11-24 1996-11-22 Matiere hemostatique et appareil d'hemostase

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP7/306162 1995-11-24
JP30616295 1995-11-24

Publications (1)

Publication Number Publication Date
WO1997018851A1 true WO1997018851A1 (fr) 1997-05-29

Family

ID=17953799

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1996/018747 WO1997018851A1 (fr) 1995-11-24 1996-11-22 Matiere hemostatique et appareil d'hemostase

Country Status (3)

Country Link
EP (1) EP0869828A1 (fr)
AU (1) AU1081097A (fr)
WO (1) WO1997018851A1 (fr)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998052609A1 (fr) * 1997-05-19 1998-11-26 Nycomed Imaging As Therapie sonodynamique mettant en oeuvre un compose sensibilisant ultrasonore
WO1999034857A1 (fr) * 1998-01-08 1999-07-15 Sontra Medical, Inc. Transport transdermique par sonophorese ameliore
EP0989822A4 (fr) * 1997-06-23 2004-07-28 Focus Surgery Inc Procedes et dispositifs d'hemostase acoustique
US7066884B2 (en) 1998-01-08 2006-06-27 Sontra Medical, Inc. System, method, and device for non-invasive body fluid sampling and analysis
US7432069B2 (en) 2005-12-05 2008-10-07 Sontra Medical Corporation Biocompatible chemically crosslinked hydrogels for glucose sensing
US8870810B2 (en) 1998-12-18 2014-10-28 Echo Therapeutics, Inc. Method and apparatus for enhancement of transdermal transport
US9572527B2 (en) 2007-04-27 2017-02-21 Echo Therapeutics, Inc. Skin permeation device for analyte sensing or transdermal drug delivery

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2167305A (en) * 1984-11-23 1986-05-29 Vernon Smith Ultrasonic transducer for dispersal of haemorrhages in eyes
EP0226740A1 (fr) * 1985-12-14 1987-07-01 Dornier Medizintechnik Gmbh Dispositif pour thromboser au moyen d'ondes de choc
EP0351610A2 (fr) * 1988-07-01 1990-01-24 Hitachi, Ltd. Dispositif ultrasonique pour usage thérapeutique
DE3919592A1 (de) * 1988-08-19 1990-02-22 Olympus Optical Co Ultraschallbehandlungssystem
US4971991A (en) * 1987-12-01 1990-11-20 Kohshiro Umemura Physiological function enhancing agents activated by ultrasonic waves for the treatment of tumors
US5053006A (en) * 1988-04-19 1991-10-01 Watson Brant D Method for the permanent occlusion of arteries
DE4020596A1 (de) * 1990-06-28 1992-01-02 Shunro Tachibana Injektionsinstrument mit einem ultraschall-schwingenden element
WO1994006355A1 (fr) * 1992-09-14 1994-03-31 Coraje, Inc. Appareil et procede ameliorant la phonophorese intravasculaire, comprenant la dissolution d'occlusions intravasculaires et l'inhibition concomitante de restenoses

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2167305A (en) * 1984-11-23 1986-05-29 Vernon Smith Ultrasonic transducer for dispersal of haemorrhages in eyes
EP0226740A1 (fr) * 1985-12-14 1987-07-01 Dornier Medizintechnik Gmbh Dispositif pour thromboser au moyen d'ondes de choc
US4971991A (en) * 1987-12-01 1990-11-20 Kohshiro Umemura Physiological function enhancing agents activated by ultrasonic waves for the treatment of tumors
US5053006A (en) * 1988-04-19 1991-10-01 Watson Brant D Method for the permanent occlusion of arteries
EP0351610A2 (fr) * 1988-07-01 1990-01-24 Hitachi, Ltd. Dispositif ultrasonique pour usage thérapeutique
DE3919592A1 (de) * 1988-08-19 1990-02-22 Olympus Optical Co Ultraschallbehandlungssystem
DE4020596A1 (de) * 1990-06-28 1992-01-02 Shunro Tachibana Injektionsinstrument mit einem ultraschall-schwingenden element
WO1994006355A1 (fr) * 1992-09-14 1994-03-31 Coraje, Inc. Appareil et procede ameliorant la phonophorese intravasculaire, comprenant la dissolution d'occlusions intravasculaires et l'inhibition concomitante de restenoses

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998052609A1 (fr) * 1997-05-19 1998-11-26 Nycomed Imaging As Therapie sonodynamique mettant en oeuvre un compose sensibilisant ultrasonore
US6498945B1 (en) 1997-05-19 2002-12-24 Amersham Health As Sonodynamic therapy using an ultrasound sensitizer compound
EP0989822A4 (fr) * 1997-06-23 2004-07-28 Focus Surgery Inc Procedes et dispositifs d'hemostase acoustique
WO1999034857A1 (fr) * 1998-01-08 1999-07-15 Sontra Medical, Inc. Transport transdermique par sonophorese ameliore
US6190315B1 (en) 1998-01-08 2001-02-20 Sontra Medical, Inc. Sonophoretic enhanced transdermal transport
US7066884B2 (en) 1998-01-08 2006-06-27 Sontra Medical, Inc. System, method, and device for non-invasive body fluid sampling and analysis
US8870810B2 (en) 1998-12-18 2014-10-28 Echo Therapeutics, Inc. Method and apparatus for enhancement of transdermal transport
US7432069B2 (en) 2005-12-05 2008-10-07 Sontra Medical Corporation Biocompatible chemically crosslinked hydrogels for glucose sensing
US9572527B2 (en) 2007-04-27 2017-02-21 Echo Therapeutics, Inc. Skin permeation device for analyte sensing or transdermal drug delivery

Also Published As

Publication number Publication date
AU1081097A (en) 1997-06-11
EP0869828A1 (fr) 1998-10-14

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