|Publication number||USRE40472 E1|
|Application number||US 10/816,377|
|Publication date||Aug 26, 2008|
|Filing date||Apr 1, 2004|
|Priority date||Jul 28, 1998|
|Also published as||CA2358649A1, CN1150869C, CN1338915A, DE60038961D1, EP1168996A1, EP1168996B1, US6366818, WO2000045758A1|
|Publication number||10816377, 816377, US RE40472 E1, US RE40472E1, US-E1-RE40472, USRE40472 E1, USRE40472E1|
|Original Assignee||Prostalund Operations Ab|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (60), Non-Patent Citations (1), Classifications (25), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This is a continuation in part of international application PCT/SE98/01417, filed Jul. 28, 1998, which designated the United States and for which a demand for international preliminary examination was timely made, and of U.S. application Ser. No. 08/981,878, filed Jan. 6, 1998, both of which are now abandoned.
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, BPII. 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.
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 micowaves 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 hihg 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.
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 photostat 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 the tissue. Separate devices for treating the tissue around the prostatic urethra and more distant tissue are included. Through this means it is possible to control the supply of power in a better way, which increases safety for the patient and diminishes the risk of damage caused by the treatment as a result of hihg total power output.
Further advantages and special features of the invention emerge from the following description, drawings, and dependent patent claims.
The invention will now be described in more detail with the aid of examples of embodiments with reference to the attached drawings on which:
In the embodiment of a treatment catheter according to the invention shown in
Treatment catheter 12 according to
Urinary bladder 21 is connected via bladder neck 21′ into the urethra. As can be seen in
A first heating device 10 is arranged inside treatment catheter 12 for heating of the surrounding tissue. First heating device 10 emits electromagnetic radiation, preferably in the form of microwaves. First heating device 10 preferably comprises a microwave antenna. Energy emitted from first heating device 10 is absorbed to a smaller part by the fluid, which in a common embodiment consists of water or a solution of cooking salt, and to a larger part energy radiates out and is absorbed in the surrounding tissue. Energy is supplied via feed cable 15 from energy supply unit 41 (see FIG. 6). The electromagnetic radiation emits energy to the surrounding tissue up to a certain distance from the urethra. In a preferred embodiment first heating device 10 comprises a coil antenna.
By carrying out heat treatment of the prostate tissue with two independent energy sources it is possible effectively to treat different parts of the prostate. With the invention it is thus for the first time possible to treat with heat in an effective and simultaneous manner i) the base of the bladder, ii) the prostatic urethra and adjacent area along with iii) parts in the prostate located farther away.
Feed cable 15, through which first heating device 10 is supplied with energy, becomes hot as a result of cable losses. Losses in the feed cable are typically around 1 dB per meter at the microwave frequencies that are commonly employed (500-2500 MHz). In order to avoid thermally induced injury to tissue because of these cable losses outside the area of treatment, for example on the sphincter muscle that surrounds the urethra outside the prostate, feed cable 15 is cooled. This is accomplished by cooling channels 27 that are included in treatment catheter 12 (see also FIG. 4). preferably around feed cable 15. In an embodiment according to the invention cooling channels 27 have a delimitation wall 28, at which cooling fluid circulating in cooling channels 27 returns. In this way cooling of heating device 10, reservoir 11, and the prostatic urethra with its mucous membrane is prevented. This means in turn that the power that has to be supplied from unit 14 can be decreased in comparison with techniques that use cooled treatment catheters and where cooling is done along the prostatic urethra. With lower power levels the risk of malpractice is lessened along with injury to healthy tissue outside the prostate.
In the treatment catheter fluid channel 26 that ends in balloon 18 is also present. Through it fluid can be supplied for expansion of balloon 18 when the treatment catheter is brought into the desired position for treatment. Fluid channel 26 is also used in order to empty balloon 18 after treatment is completed and before the treatment catheter is withdrawn from the urethra. A conventional hypodermic needle or similar is suitably used for the filling and emptying of balloon 18.
The heating of bladder neck 21′ and an adjacent part of prostatic urethra 40 that can be brought about by first heating device 10 is in many cases insufficient, especially in the area near bladder 21. In order to increase the possibility of heating in this area a second heating device 29 is therefore arranged in treatment catheter 12 inside fluid reservoir 11. Second heating device 29 comprises in one embodiment a resistance wire or similar with good heat transfer through treatment catheter 12 and the liquid in fluid reservoir 11.
In the embodiment shown in
Fluid 13 in the reservoir is heated by second heating device 29 to such a temperature that adjacent tissue is heated for example to 140° F. (60° C.) and coagulates. At this temperature the duration of treatment is about 1 hour. Depending on the size of the area to be treated and the chosen temperature of treatment the duration of treatment can be chosen to be both shorter and longer. By raising the treatment temperature in fluid reservoir 11 via second heating device 29 to a range of 194° F.-302° F. (90° C.-150° C.) the duration of treatment can be decreased to an order of some minutes, for example 5-20 minutes. At these hihg temperatures the tissue hardens and forms a shell and can at least for a transitional time function as a so-called stent.
Since the highest temperature is reached in the tissue closed to reservoir 11, the prostatic urethra, and the mucous membrane in the urethra, i.e. the part of the urethra that passes through the prostate in the area of treatment, will to a hihg degree be affected and thus destroyed. This part of the urethra reforms relatively quickly, however. Temperature sensors 23, 23′, and 23″ are arranged on carrier 24 in order to be able to track the temperature development during heat treatment. Carrier 24 can be extended through a channel or tube 25, which runs through the treatment catheter. Carrier 24 or temperature sensor 23 is suitably embodied with, or as, a tip that can penetrate in part a membrane or wall in the treatment catheter and in part the bodily tissue. Tube 25 is embodied so that carrier 24 with temperature sensors 23 is extended out of the treatment catheter at a suitable angle and can be driven out to a suitably radial distance from the treatment catheter. It is also possible to array several carries for the different temperature sensors 23.
A second temperature sensor 37 can also be arranged in treatment catheter 12 in or, as in the embodiment shown, inside reservoir 11 and preferably in heat-conducting contact with reservoir 11.
Heating of tissue also occurs partly at a short distance by heating of the fluid contained in the reservoir, which emits heat directly via heat conduction to adjacent tissue, and partly at a longer distance by electromagnetic radiation. The total area of treatment is larger than with conventional heating, which means that larger portions of tissue can be reached and that treatment can be adjusted better for every patient and for conditions relevant to the patient than was the case with previously known technology.
A resultant best profile, i.e. a curve which indicates the temperature of tissue radially outwards from the center of the treatment catheter, is more elongated than when only microwave or direct heat is used. It thus becomes possible to treat a larger volume. Through the fact that power from different energy sources controls both heating elements it is possibly precisely to control the appearance of the heat profile. In large prostate glands it can, for example, be advantageous to use a relatively high degree of microwave energy with a longer range, while small prostate glands can be treated with the second directly heating element with a shorter range.
First heating device 10 and second heating device 29 are preferably arranged so that the heating power can be controlled independently of each means of heating. A larger prostate is suitably treated with high power in the two hating device 10 and 29, while a smaller prostate is treated primarily or entirely with the second heating device 29. The latter course is also followed if it has been confirmed that the change in the tissues occasioned by disease is concentrated at the bladder neck and adjacent prostate tissue.
The bladder neck is most often a problem when heat treating BPH, because the bladder neck often has a high degree of blood flow and thus a high transfer away of heat. The result is that the temperature often doe not become sufficiently high to bring about a coagulation of tissue merely with microwaves. This problem is avoided with the invention as now designed in that the bladder neck is instead mainly heated directly by second heating device 29 and the liquid in fluid reservoir 11. The liquid, which is in good thermal contact with the bladder neck, has such a high temperature (>140° F.; 60° C.) that the outer parts of the bladder neck are coagulated because of heat transfer. If the temperature in fluid reservoir 11 is sufficiently high, the blood flow in the bladder neck no longer matters, since the coagulation of the tissue happens very quickly.
When treatment has ended, the supply of energy to heating device 10 and 29 is interrupted and reservoir 11 is allowed to return to normal body temperature. It is unsuitable to remove the treatment catheter as long as the reservoir has a temperature that can cause injury when the reservoir is passed through the body. For this reason the temperature in reservoir 11 is registered constantly, so that removal of the treatment catheter can occur as soon as the desired temperature has been reached.
When catheter 12 is introduced into the urethra with a tip in urinary bladder 21, drainage of urine and perhaps other liquid from the urinary bladder can occur through a drainage channel incorporated in catheter 12. The drainage channel runs through the whole length of catheter 12 and ends with an opening 20 near the tip of catheter 12. With certain types of treatment it can be suitable to leave catheter 12 for some time after treatment. Even during this time the function of the drainage channel is to drain the urinary bladder.
As soon as urine again passes through the urethra in the prostate, the treated and dead tissue will be able to flush with the urine. A remaining cavity in the prostate caused by removed tissue assures the passage of urine in the correct manner. The cavity initially has a form that corresponds with the form of reservoir 11 during the time of treatment, i.e. with the largest cross-area closest to urinary bladder 21. The healing process including the rejection of coagulated tissue can continue for a time of some months.
As a complement to, or part of, the heat treatment according to the above, some form of medicine can be introduced into fluid reservoir 11 Fluid reservoir 11 is modified in that case so that is allows passage of the medicine. Fluid reservoir 11 is suitably embodied so that the medicine can diffuse through the wall of fluid reservoir 11, but it is also possible to incorporate permeable channels or similar in the wall. According to one treatment, medicine against pain can be included in the fluid. Other medicines can also be used for direct treatment.
In the embodiment according to
In the embodiment shown in
The block diagram in
Control unit 32 is operatively connected with temperature sensor 23 and 37 and can control energy supply unit 14 dependent on the current temperature in the area of treatment so that suitable power is supplied to heating device 10. In this manner it is possible to increase the temperature considerably with good safety in fluid reservoir 11 and thus in surrounding tissue so that tissue death occurs in the desired way. Data on temperature from temperature sensors 23 and 37 can also be shown continuously on display unit 33.
Pumping and cooling device 34 is connected with cooling channels 27 and pumps suitable cooling fluid through cooling channels 27 in order primarily to cool feed cable 15 while it is being extended forward to heating device 10. Fluid supply device 35 is used when fluid reservoir 11 is to be filled and expanded. The filling can be monitor ed by control unit 32.
A preferred embodiment according to the invention also includes a pressure meter 39, which is operatively connected with fluid supply device 35. Pressure meter 39 is also operatively connected with central control unit 32 in order that the pressure in fluid reservoir 11 can influence the process of treatment. The pressure can be changed depending on now the treatment is progressing. For reasons of safety the treatment should be able to be interrupted if the pressure in fluid reservoir 11 falls abruptly, for example, for the reason that fluid reservoir 11 breaks.
Reservoir 11 is completely closed and contains a certain volume of fluid 13 with suitable properties of heat transfer. Examples of such fluids are silicon oil and water. Reservoir 11 is embodied of elastic silicon or another material with corresponding elastic properties, for example, latex. Even treatment catheter 12 can be embodied of silicon or similar material, as can bladder 18.
The embodiment shown in
First heating device 10 and second heating device 20 are comprised of a combined means in the form of the coaxial cable that conducts microwaves to a radiator (antenna) and direct current or low-frequency alternating current to a resistor. The resistor and the radiator are comprised of the same physical construction, which functions differently dependent on whether it is fed with microwaves or direct current/low-frequency alternating current. In this variant the antenna itself is comprised of a closed loop with a certain inductance L and a resistance R that connects the inner conductor of the coaxial cable with the outer conductor in such a way that the loop, when it is fed with microwave energy, functions as an antenna and radiates the energy. In the case when it is fed with direct current/low frequency alternating current it functions only as a resistive load and develops heat when the current passes through the loop. The antenna also displays a certain capacitance.
In a typical case the loop has a pure resistance in the range of 1-20 ohms, for example 1 ohm with direct current, while with high frequency (HF) it has 50 ohms as a result of inductance of the coil. The resistive load will be a lesser part of the total HF-load, so that the larger part of supplied microwave power radiates out from the antenna. The material in the coil is chosen so that suitable resistance is obtained (i.e., in th range of some ohms). When such an antenna is fed with 40 watt microwave power (a typical value with microwave treatment), in the above-mentioned case 1/50*40=0.8 watt heating power will be developed in the radiator itself, while 49 watts radiate out. This means that the antenna does not significantly affect the temperature of the fluid in reservoir 11 through direct effect, since 0.8 W is too little power to cause effective heating of reservoir 11.
Conversely, when the construction is used instead only with direct current/low frequency alternating current 25W of heat will be developed and directly heat the fluid in balloon 11 at an input current of 5 amperes (5 volts input). It is worth nothing that the coaxial cable is a suitable carrier of both microwave energy and direct current/alternating current up to some tens of amperes. By using coaxial cable 15 in this dual manner, one gains the advantage of having a cable system that at the same time is tough enough to conduct both microwave energy and high current (10A) at a low voltage (for example 10 Volts). This means that one can aviod high voltage for the direct current component with its concurrent safety risk for the patient.
In an alternate embodiment according to
By alternately transmitting microwaves and direct current/low feruqncy alternating current through the construction, the operator has the possibility to moderate the temperature in fluid reservoir 11 with the resistive part of the invention in order to achieve coagulation of tissue in close proximity to the prostatic urethra including the bladder neck. The temperature in fluid reservoir 11 should not be less than 140 (60° C.) and best up towards 176° F.-194° F. (80° C.-90° C.) or more. This is in order to make brief treatment possible. During the microwave phase more peripherally lying areas are affected, but the temperature there will be lower, around 122° F.-140° F. (50° C.-60° C.). For this reason the time taken in order to achieve coagulation of tissue in these more distant areas will be correspondingly longer. The microwave part is especially important for larger prostate glands because of its greater range in comparison with pure heat conduction. Typical radial penetration of coagulation by means of heat conduction from fluid reservoir 11 is 5-8 mm. Corresponding penetration of coagulation by microwaves is up to 20-30 mm.
In a typical embodiment the system is run in multiplex intervals of 1-60 seconds with microwaves and 1-60 seconds with direct current/low feruqncy alternating current depending on which temperature obtains at the time in peripheral area of the prostate or in the area near the prostatic urethra, after which the sequence is repeated. In an alternate embodiment the treatment is first completed with the fluid typically for 15 minutes without interruption, and after that using only microwaves for another 45 minutes.
In an alternate embodiment in accordance with the invention electronic unit 44 includes a so-called bias-tee component. This isolates microwave generator 42 from direct current assembly 43, so that these are simultaneously connected with feed cable 15. In this way microwave energy can be supplied at the same time as direct current or low frequency current. The different characteristics dependent on frequency in first heating device and second heating device 29 mean that microwave energy or direct current energy can be supplied and emitted simultaneously from the respective heating devices. A bias-tee component includes, as in indicated in
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|International Classification||A61B18/08, A61F2/00, A61B17/00, A61B18/18, A61F7/00, A61F7/12, A61M25/00, A61N5/04|
|Cooperative Classification||A61B2017/00274, A61B18/08, A61B2018/00547, A61B2018/00261, A61B2018/00791, A61B2018/00285, A61F2007/0088, A61B2018/00577, A61B2018/1861, A61F7/12, A61B18/1815, A61B18/18|
|European Classification||A61B18/18M, A61B18/18, A61F7/12, A61B18/08|
|Sep 11, 2009||FPAY||Fee payment|
Year of fee payment: 8
|Sep 27, 2013||FPAY||Fee payment|
Year of fee payment: 12
|Sep 27, 2013||AS||Assignment|
Owner name: PROSTALUND AB, SWEDEN
Effective date: 20120313
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:PROSTALUND OPERATIONS AB;REEL/FRAME:031313/0871