Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Thermal applicators
Reexamination Certificate
1999-08-23
2002-04-02
Gibson, Roy (Department: 3739)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Thermal applicators
C607S102000, C607S116000, C607S156000, C606S033000
Reexamination Certificate
active
06366818
ABSTRACT:
TECHNICAL FIELD OF THE INVENTION
The invention concerns a method and device for heat treatment of bodily tissue.
Heat treatment yields good treatment results with certain types of disease conditions involving unnatural growth of tissue. The tissue is heated to the extent that it dies. Examples of such disease conditions are certain types of cancer and benign prostate hyperplasy, BPH. During treatment certain portions of the tissue are heated so that tissue death ensues, while other portions of tissue must or should be protected. The disease conditions which are primarily indicated are those which occur in tissue surrounding cavities in the body.
Corresponding disease conditions can also occur in animals, where corresponding treatment can be brought to bear. Above all, treatment of the prostate in domestic animals, such as dogs, can be topical.
STATE OF THE ART
Different devices can be used in order to induce heating. Devices for heating by means of laser as well as with microwaves and radio frequencies are common. A technique is known through U.S. Pat. No. 5,257,977, according to which a catheter is provided with a reservoir for fluid. The reservoir is flexible and is connected via channels through the catheter with a heating device located outside the body. A fluid is heated in a heating device and circulated through the channels and the reservoir that to some degree expands for better contact with the tissue. The rise of temperature in the reservoir also brings about heating of the surrounding tissue. Treatment is affected by controlling the temperature of the circulating fluid.
Since the channels pass through tissue that should not be treated, they must be heat insulated. According to U.S. Pat. No. 5, 257,977 the heat insulation is brought about by means of a space filled with gas that surrounds the channels. The function of the heat insulation is very important, for which reason great care and considerable expense must be devoted to this part of the treatment catheter. Another disadvantage with the device according to U.S. Pat. No. 5,257,977 is that desired control of the temperature is difficult to achieve for the reason that the distance between the heating device and the area of treatment is relatively large and because the temperature of the circulating fluid should not exceed 140° F. (60° C.) in order to avoid an effect on the urethra outside of the prostate and penis brought about by heat in the in/out channels.
A more highly developed catheter for treatment is shown and described in WO 97/02794, according to which a heating device is contained inside an expandable reservoir. The heating device is provided with energy from an assembly outside of the body for heating of fluid inside the reservoir. Some of the disadvantages involving undesirable heating of certain tissue are avoided in this manner. The heating device is designed according to WO 97/02794 as a resistance wire or similar and heats the fluid through convection. The heat transferred from the fluid to the surrounding tissue gives locally good results. A disadvantage is that the effect in the tissue at a farther distance from the reservoir is insignificant, for which reason the volume of tissue that can be treated is limited with this technique.
Heat treating with a treatment catheter that is equipped with a microwave antenna is also known with the mentioned course of disease. Examples of such microwave treatment are known previously through U.S. Pat. No. 5,480,417 and U.S. Pat. No. 5,234,004. Characteristic for previously known microwave treatment is that the prostate tissue is heated with microwaves. The intention is to heat parts of the prostate gland. The element that emits the microwave radiation consists of a coaxial cable that is included in a catheter for treatment. Cooling fluid circulates through the catheter. The intention with the cooling is to protect the prostatic urethra, that is to say the part of the urethra that runs through the prostate gland from being affected and damaged by the heat that is generated by the microwaves. Another reason for cooling the catheter is to transport away waste heat in the coaxial cable.
In several of these previously known techniques cited earlier the goal of the treatment was not made explicit but it was rather merely indicated that the invention should be used for heat treatment of the prostate. Different levels of heat treatments occur in the literature. So-called hyperthermy treatments have in general the goal only to increase the temperature moderately, <113° F.; 45° C. It is known that histological changes in tissue do not occur with temperatures less than 113° F. (45° C.) and that the temperature must exceed 122° F. (50° C.) in order to achieve destruction of tissue in a short time, on the order of one hour or less. In connection with the described invention heat treatment is meant to have such a high temperature that the tissue coagulates, i.e., dies.
It has long been viewed as important to protect the prostatic urethra during microwave treatment of benign prostate enlargement. This protection of the prostatic urethra hinders the treatment from being really effective, however, since parts of the obstructing tissue closest to the urethra are not heated sufficiently in order to coagulate because of the cooling. Neither are there any medicinal-scientific attestations that non-destruction of the prostatic urethra should be preferred. To the contrary it can be argued that destruction of the prostatic urethra along with other tissue means that necroticized tissue is not encapsulated but is naturally discharged with urine during the healing process. The clinical result of heat treatment of the kind envisioned here is dependent on the amount of tissue that coagulates. The degree of coagulation depends in turn on temperature in combination with the length of treatment. The temperature in turn depends on the input of energy and the carrying away of heat by the blood flow. Since different parts of the prostate can have different degrees of blood flow, there is a risk that certain areas will not achieve therapeutic temperature when microwaves are used for heating.
There are also designs with uncooled catheters for treatment. In these the microwave power has been so low that the tissue temperature has not been sufficient to achieve coagulation. Because of cable losses the development of heat in the feed cable (coaxial cable) itself that transmits microwaves through the urethra to the prostate is so high that uncooled catheters can be used only with low microwave power, for example 20 watts. This magnitude is insufficient to bring about tissue necrosis in the prostate and produces only an insignificant heating of the tissue. Equipment of this kind also yields generally poor objective treatment results.
THE INVENTION IN SUMMARY
A purpose of the invention is to increase the effectiveness of treatment with a treatment catheter of previously known technology at the same time as to diminish the risk of maltreatment of tissue. The diminution of risk depends among other things on decreasing the amount of microwave power applied in comparison with known technology. The duration of treatment can also be shortened many times with the invention shown in comparison with known technology. According to preferred embodiments it will also be possible partly to treat tissue far from the prostatic urethra and partly to secure destruction of the prostatic urethra itself and the surrounding area in a controlled way. This purpose is achieved by incorporation of the special features described in patent claims
1
and
12
, respectively.
The effectiveness of treatment is increased in that a device for treatment according to the invention comprises means developed to expand the treatment catheter in the longitudinal direction from the apex of the prostate or beyond all the way up to and including the base of the bladder. The cavity that is constituted by the prostatic urethra is filled by a bolus or reservoir filled with fluid so that a good fit occurs between the treatment catheter and t
Gibson Roy
Matthews, Collins, Shepherd & Gould, P.A.
Prostalund Operations AB
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