Therapeutic device and method of inducing thrombosis in a blood

Surgery – Truss – Pad

Patent

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128785, 128641, A61N 104

Patent

active

045222053

DESCRIPTION:

BRIEF SUMMARY
TECHNICAL FIELD

This invention relates to a therapeutic device and a method for its use and, more particularly, to apparatus for inducing thrombosis in a blood vessel to control haemorrhage or potential bleeding. Haemorrhage or potential bleeding is a problem in many surgical situations, for example, gastro-intestinal tract bleeding, urinary tract bleeding and per- and post-operative bleeding. Specific examples are haemorrhage from varicose veins (varices) of the oesophagus, from the prostatic bed after prostatectomy, from haemorrhoids, from the liver after cholectystectomy (removal of the gall bladder) or liver resection, from operative manipulation and trauma, from aneurysms and from varicose veins other than of the oesophagus. In some cases, the occurrence of acute ailments, for example, varices of the oesophagus, is rapidly increasing, accounting for tens of thousands of fatalities annually.


BACKGROUND ART

Acute bleeding of oesophageal varices is commonly treated by use of a tamponade tube, such as the Sengstaken-Blakemore tube which was first introduced in 1950, which tube restricts the flow of blood through the vessel, thereby assisting blood coagulation by natural mechanisms. One study has indicated that it will provide initial control of bleeding in over 80% of patients. However, in over 60% of these patients rebleeding will occur when the tube is withdrawn. In the patients who rebleed, there is a 60% rate of mortality.
A number of methods of further treatment are available once bleeding has been arrested. Injection of the varices with a sclerosing agent is feasible only with variceal observation e.g. by an endoscope unobscured by bleeding. Mortalities of around 50% have been found with emergency portasystemic shunting or with gastric or oesophageal surgery. There is a high incidence of rebleeding associated with the use of vasopressin. Thus, none of the methods so far proposed is associated with a high rate of success.
The application of electrical current to induce thrombosis was employed by Lutz in 1951; see Circulation 1951; 3:339-351. Sawyer has demonstrated that passage of current across a normal blood vessel precipitates a thrombus only at the anode; See Amer.J.Physiol. 1960; 198:1006-1010.


DISCLOSURE OF INVENTION

The present invention has as one object to provide an apparatus method which makes possible long-term control of haemorrhage in blood vessels by a non-surgical method, and which is less hazardous to the patient than the methods previously proposed.
According to the present invention there is provided apparatus for inducing thrombosis in a blood vessel subjacent a surface of a living human or animal body, characterised in that it comprises a therapeutic electrode which is flexible enough to conform to said surface, means for maintaining the electrode in contact with the surface and for restricting the flow of blood through the blood vessel during induction of thrombosis therein, the apparatus being provided with leads for electrical connection of the electrode to a source of direct electrical current and so constructed as to support passage of said electrical current through the blood vessel between the therapeutic electrode as anode and a counter cathode for a period of time and at a current density at the surface of the anode sufficient to induce thrombosis in the blood vessel, the anode being non-toxic and resistant to anodic electrochemical dissolution during said period of time.
The means for maintaining the electrode in contact and the means for restricting flow will normally be the same but need not be. The apparatus is totally unlike a diathermy device and does not rely on electrically-generated heat for its effectiveness.
It is an important feature of the invention that it permits treatment of blood vessels during acute bleeding thereof, in distinction from those prior art treatments which can be carried out only after bleeding has been arrested temporarily. With the apparatus of the invention a potential for long-term control is present in the same treatment that pr

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Schaudinischky, L. et al. "Technical Note: The Shape Conforming Electrode", Med. and Biol. Engng. vol. 7, No. 3, May 1969, pp. 341-343.

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