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Patent Searching and Data


Title:
HEMOSTASIS MATERIAL AND APPARATUS
Document Type and Number:
WIPO Patent Application WO/1997/018851
Kind Code:
A1
Abstract:
A method and apparatus 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.

Inventors:
TACHIBANA KATSURO (JP)
TACHIBANA SHUNRO (JP)
Application Number:
PCT/US1996/018747
Publication Date:
May 29, 1997
Filing Date:
November 22, 1996
Export Citation:
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Assignee:
EKOS CORP (US)
TACHIBANA KATSURO (JP)
TACHIBANA SHUNRO (JP)
International Classes:
A61M37/00; A61N7/00; A61B17/12; A61B17/22; (IPC1-7): A61M37/00; A61N7/00
Domestic Patent References:
WO1994006355A11994-03-31
Foreign References:
US4971991A1990-11-20
DE3919592A11990-02-22
EP0351610A21990-01-24
EP0226740A11987-07-01
US5053006A1991-10-01
DE4020596A11992-01-02
GB2167305A1986-05-29
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Claims:
CLAIMS
1. A method for enhancing phonophoresis comprising introducing a cavitation threshold reducing agent to a body, and applying ultrasound energy at a selected site in the body at a frequency sufficient to produce a therapeutic effect .
2. The method of claim 1, wherein the cavitation threshold reducing agent is Rose Bengal.
3. The method of claim 1 , wherein the cavitation threshold reducing agent is hematoporphryn.
4. A method for creating hemostasis comprising introducing a cavitation threshold reducing agent to a body, and applying ultrasound energy at a selected site in the body at a frequency sufficient to create hemostasis.
5. The method of claim 4, wherein the cavitation threshold reducing agent is Rose Bengal.
6. The method of claim 4, wherein the cavitation threshold reducing agent is hematoporphryn.
7. An apparatus for creating hemostasis comprising a cavitation threshold lowering agent means, and ultrasound energy means coupled to the cavitation threshold lowering agent means and generating an ultrasound energy wavelength sufficient to create hemostasis at a selected site in a body.
8. The apparatus of claim 7, wherein the threshold lowering agent is Rose Bengal .
9. The apparatus of claim 7, wherein the threshold reducing agent is hematoporphryn.
10. An apparatus for creating hemostasis compnsing a hemostasis agent means, and ultrasound energy means generating an ultrasound frequency that creates hemostasis at a selected site in a body.
11. The apparatus of claim 10, wherein the threshold loweπng agent is Rose Bengal.
12. The apparatus of claim 10, wherein the threshold reducing agent is hematoporphryn.
Description:
HEMOSTASIS MATERIAL AND APPARATUS BACKGROUND OF THE INVENTION

Field ofthe Invention This invention relates generally to hemostasis, and more particularly to a method and apparatus to cause hemostasis using ultrasound and ultrasound sensitive drugs

Description of Related Art In the case of death by car accidents, gastric ulcers, ruptures of esophageal varices, massive bleeding is a frequent cause of death Particularly in emergency situations, It is important to stop bleeding as quickly as possible To increase the rate of survival, it is essential to stop the bleeding as s quickly as possible In auto accidents, strong mechanical forces frequently cause damage to internal organs in the abdomen This is a major cause of death When endoscopic fibers or catheters cannot be used for treatment of rupture of organs or intra-liver bleeding, it is difficult to stop bleeding without surgical intervention This is why it is difficult to effectively stop the bleeding at the accident site before transfer to a hospital

With bleeding from gastric ulcers or esophageal varices rupture, there are several methods of endoscopy to stop bleeding However, this is not 100% effective The current treatment used for hemostasis is laser or high radio frequency energy to burn the origin ofthe bleeding However, the success rate is not that high Current treatment methods can cause damage to locations other than the at the site of bleeding

Another method of treatment is the use of drugs as thrombin which chemically induce reactions and cause coagulation In one method, the drug is sprayed to the bleeding site and coagulation reaction is activated However, this is not completely effective to stop all bleeding

BRIEF DESCRIPTION OF THF FIGURES Figure 1 is a diagram illustrating the treatment of bleeding when it is difficult to use catheters or endoscopes

Figure 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

SUMMARY

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

These and other objects ofthe invention are achieved in 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 In one embodiment, 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

In another embodiment ofthe invention, 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.

In one embodiment the cavitation threshold lowering agent is Rose Bengal or a hematoporphryn.

DETAILED DESCRIPTION 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

Any number of 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.

After intravenous injection ofthe ultrasound sensitive drug and delivery ofthe drug to the bleeding site, the site ofthe bleeding is exposed to ultrasound from an ultrasound device This results in activation ofthe ultrasound sensitive drug and coagulation ofthe blood In this way, hemostasis is achieved quickly and efficiently.

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.

Referring now to Figure 1 , there are times when it is difficult to use catheters or endoscopes to stop bleeding from organs An ultrasound sensitive drug is first intravenously injected into the patient An ultrasound diagnostic device is used (not shown in the diagram) to patient A. After locating and confirming the bleeding site C in organ B, ultrasound therapy is performed with the ultrasound therapeutic device 1 by concentrating ultrasound energy at bleeding site C for the purpose of coagulating the blood at the site ofthe damaged organ, vessel and the like. Referring now to Figure 2, a suitable therapeutic ultrasound device 1 is shown. In one embodiment, 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. By loading the electrode with ultrasound frequency electrical signals, ultrasound is emitted in the direction ofthe arrows

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.

Figure 4 shows the cross section view ofthe structure of an endoscope 2 useful with the present invention. In the method of treatment, the ultrasound sensitive drug is first intravenously injected to the patient Then 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 Locally or in a large area,

hemostasis is performed by exposing ultrasound from ultrasound vibrating element 2c. In one embodiment, 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.

In one embodiment, 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. When ultrasound vibrating elements 2c are shaped in a cylinder, ultrasound energy is emitted evenly toward the radius ofthe axis of endoscope 2. However, the shape of ultrasound vibrating element 2c is not limited to illustrated geometry . In other embodiments, 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. In embodiment, 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. Deep locations ofthe body including but not limited to the liver, abdominal aorta, other organs bleeding and the like, are treated without surgical

intervention. Because ultrasound energy is used, body organs and structure are not damaged. This is in contrast with and will be safely used compared with laser or high radio frequency therapies where body organs and structures can be suffer damage when energy from these sources is applied to the body The foregoing description of a preferred embodiment ofthe invention has been presented for purposes of illustration and description It is not intended to be exhaustive or to limit the invention to the precise forms disclosed Obviously, many modifications and variations will be apparent to practitioners skilled in this art It is intended that the scope ofthe invention be defined by the following claims and their equivalents

What is claimed is