JP2001046388A - Heating treatment device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a heating treatment device capable of accurately and easily setting a treatment condition for effectively heating only a lesion site while preventing damage to normal tissues around the lesion site corresponding to the disease condition of each patient. SOLUTION: A prediction part 12 predicts a distance from an emission end 111a, that is the surface of a surface layer 21, to the point that a highest temperature is reached in viable tissues and the highest temperature by utilizing a relational expression stored in a memory 9 based on the treatment conditions inputted through an input part 8, that are the output of laser beams, the irradiation time of the laser beams, the temperature of coolant and the flow rate of the coolant. The predicted values are displayed on a monitor 7. An operator finds appropriate treatment conditions by referring to the predicted values displayed on the monitor 7 and inputting new treatment conditions again. Thus, the operator confirms that the set treatment conditions are not erroneous before treatment.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a heating apparatus for irradiating a living tissue with energy such as laser light, microwaves, radio waves, or ultrasonic waves, and performing heat treatment for tumors such as cancer and prostatic hyperplasia. It relates to a treatment device.

[0002]

2. Description of the Related Art The prostate is located at the bottom of the male bladder and surrounds the posterior urethra. Benign prostatic hyperplasia
The incidence rate increases with aging, and 75-
It is said to occur in 80%. When the prostate enlarges, the posterior urethra is compressed, causing urethral narrowing. Early symptoms of benign prostatic hyperplasia include difficulty urinating, fine urinary lines, frequent urination, and discomfort during urination. When the symptoms worsen, urinary tract infection, urinary retention, and hydronephrosis may occur.

[0003] As a method for treating prostatic hypertrophy, transurethral resection of the prostate (TURP) is known.
The prostate) is commonly done. This TUR
In P, a resection mirror is inserted into the urethra, and the enlarged prostate tissue is resected by a resection wire inserted through the resection mirror. However, this method involves excision of the urethral surface along with the prostate tissue, which can cause post-operative pain and infection problems. In addition, there is a risk that the sphincter and sperm may be resected, and complications such as urinary incontinence and retrograde ejaculation may become a problem.

On the other hand, urethral balloon dilatation is known as a method for treating the urethra while preserving it. In this method, a catheter body having a tip of an inflatable balloon (balloon) is inserted into a prostatic urethra, and then the balloon is inflated. The inflated balloon dilates the urethra and is maintained for a period of time with the urethra expanded.
This holding time is 10 to 60 minutes. It has also been proposed to insert a stent after dilatation of the urethra with a balloon and then remove the stent later. However,
This method involves removing the balloon or stent,
The rate at which the urethra narrows again is not small.

As a method for treating the urethra while preserving the urethra, there is known a urethral microwave high temperature treatment.
In this method, a catheter body having a built-in microwave antenna in a radial urethra is inserted into the prostatic urethra, and cooling water is circulated through the catheter body to cool the urethra while irradiating the microwave to heat and treat the prostate. Things. However, in this method, it is difficult to achieve both urethral cooling and prostate heating due to the nature of microwaves, and if the degree of prostate heating is increased to enhance the therapeutic effect, urethral preservation will not be possible.

Further, as a method for treating the urethra while preserving the urethra, Japanese Patent No. 2647557 proposes radial urethral needle ablation. In this method, the catheter body is inserted into the prostatic urethra in a radial urethra, a needle is inserted into the prostate deep from the distal end of the catheter body, and radio waves are flowed using the needle as an electrode to heat-treat the prostate. However, in this method, since the portion to be heated is limited to a narrow range around the electrode needle, the above operation needs to be performed a plurality of times in order to obtain a desired therapeutic effect. Therefore, this method is complicated in operation and is not very invasive.

On the other hand, as a method of treating the urethra while preserving it, Japanese Patent Publication No. Hei 6-510450 proposes a method of coagulating and reducing a tumor or a part of a prostate tissue by laser irradiation. . According to the device using this method, by injecting the cooling liquid into the balloon, without heating the urethral surface in contact with the balloon,
It is possible to heat-treat only the inside of the prostate by laser irradiation.

[0008]

However, in a heat treatment apparatus that irradiates energy to a living tissue and performs heat treatment, such as the apparatus described in Japanese Patent Publication No. 6-510450, The setting of the treatment condition is performed by the following method. In other words, the surgeon himself / herself judges based on his / her experience, and sets treatment conditions such as the output of the heat source such as laser light, the irradiation time of the heat source, the coolant temperature when using the coolant, and the coolant flow rate when circulating the coolant. The method of inputting individually is adopted.

[0009] Therefore, the surgeon must predict the temperature of the target site for performing the heat treatment by himself, and there is a problem that the accuracy of predicting the temperature of the target site varies depending on the degree of experience of the surgeon. . For this reason, treatment is performed under inappropriate treatment conditions, and as a result, sufficient therapeutic effect may not be obtained due to insufficient irradiation of energy.On the other hand, excessive heating may cause pain, etc. There is a risk of damaging normal tissues.

[0010] The present invention has been made in view of such problems of the prior art, and an object of the present invention is to prevent damage to normal tissues around a lesion site in accordance with the individual disease state of a patient. Another object of the present invention is to provide a heat treatment apparatus capable of accurately and easily setting treatment conditions for effectively heating only a lesion site.

[0011]

The object of the present invention is achieved by the following means.

(1) In a heat treatment apparatus that irradiates energy to a living tissue and performs heat treatment, the living tissues to be heated correspond to each other based on treatment conditions set for performing heat treatment. A heat treatment apparatus comprising a prediction unit for predicting a temperature and a position.

(2) The heat treatment apparatus according to the above (1), further comprising display means for displaying a result predicted by the prediction means.

(3) The heat treatment according to the above (1) or (2), wherein the predicting means predicts a position of a living tissue to be heated which has the highest temperature and the highest temperature. apparatus.

(4) The heat treatment apparatus according to (1) or (2), wherein the prediction means predicts a temperature distribution within a predetermined range of the living tissue to be heated.

(5) The method according to any of (1) to (4), wherein when the temperature exceeds a predetermined temperature, energy irradiation is prohibited or a warning is given to an operator. The heat treatment device according to claim 1.

(6) There is provided a long insertion portion which can be inserted into a living body, and energy is irradiated toward living tissue from an emission portion provided in the insertion portion. The heat treatment apparatus according to any one of (1) to (5).

(7) The heat treatment apparatus according to the above (6), further comprising a cooling means for cooling the emission section and the energy irradiation surface of the living tissue.

(8) A moving means for moving the position of the emission section in the axial direction of the insertion section, and changing an emission angle of energy emitted toward living tissue with the movement of the emission section in the axial direction. The heat treatment apparatus according to claim 6, further comprising: interlocking means for causing the heat treatment apparatus to operate.

(9) The heat treatment apparatus according to any one of (1) to (8), wherein the energy is a laser beam.

(10) The treatment conditions set for performing the heat treatment include the output of the energy, the irradiation time of the energy, the temperature of the coolant when the coolant is used, and the temperature of the coolant when the coolant is sent. The above item (1), which is one or more items selected from the group consisting of a flow rate of the cooling liquid and a moving speed of the emission part when the emission part for irradiating energy is moved. The heat treatment apparatus according to any one of (1) to (9).

[0022]

Embodiments of the present invention will be described below with reference to the drawings.

FIG. 1 is a system configuration diagram of a heat treatment apparatus according to an embodiment of the present invention, FIG. 2 is a perspective view of a laser light irradiation apparatus, and FIG. 3 is a cross-sectional view of a tip of the laser light irradiation apparatus. is there.

The heat treatment apparatus 10 shown in FIG. 1 has a side-projection type laser beam irradiation device 1 for irradiating a living tissue with a laser beam. The heat treatment device 10 includes a main body 110 as a long insertion portion of the laser light irradiation device 1 in a living body.
Is inserted, and from the emission unit 111 installed in the main body 110,
Laser treatment is performed by irradiating the living tissue 20 with laser light, and is used, for example, for treatment of tumors such as benign prostatic hyperplasia and various cancers.

As shown in FIGS. 2 and 3, the laser beam irradiation apparatus 1 has a long body 110, an emission section 111 for irradiating laser light, an emission section 111, and a main body 110. And a housing 112 connected to the distal end. One arm 116 is connected to the emission unit 111. The arm 116 supports the emission unit 111 in the housing 112. By moving the arm 116 in the axial direction of the main body 110, the emission unit 111 is moved in the axial direction. The emission unit 111 has a smooth reflecting surface 127 formed on one side and reflecting a laser beam.

The housing 112 is formed of a rigid tubular body having a window 115 for irradiating a laser beam, and is covered by a cover member 113 that transmits laser light. The housing 112 has an inner wall provided with a pair of grooves 132 for changing the irradiation angle of the emission unit 111. Emission part 11
The grooves 132 functioning as one guide are disposed on both sides of the emission section 111 and are inclined with respect to the axial direction of the main body 110. The tip of the housing 112 is sealed by a cap 114.

An optical fiber 118 for guiding a laser beam
Are arranged inside the main body 110. Optical fiber 1
18 is an energy transmission member. A tip lens may be provided at the tip of the optical fiber 118. This tip lens is an optical element for converging the laser light into parallel light. The optical fiber 118 transmits the laser light generated by the laser light generator 2. The shock absorber 181 contains an optical fiber forming a loop, and absorbs the movement of the optical fiber.

The laser beam irradiation device 1 further has a detachable oblique viewing type endoscope 180. Endoscope 180
Goes from the base end to the tip end of the laser beam irradiation device 1,
Has been inserted. The optical fiber of the endoscope 180 that emits illumination light also has a function of emitting guide light. Therefore, observation of the surface layer irradiated with the laser beam, positioning of the housing based on endoscopic observation, and visual confirmation of the laser beam irradiation position can be executed.

FIG. 4 is a perspective view for explaining the structures of the emitting section and the arm of the laser beam irradiation device.

Since the arm 116 branches right and left in the housing 112 and supports the emission unit 111, it does not prevent the laser beam from impinging on the surface of the emission unit 111. The emission part 111 is provided with a support part 128 on one side, and on the other side,
A pair of protrusions 133 are provided. The support portion 128
The light emitting unit 1 is rotatably attached to the arm 116.
11 can be changed. Protrusion 1
33 is a groove 132 disposed on the inner wall of the housing 112.
Mates with

The arm 116 is connected to a drive unit 150 arranged at the base end of the laser beam irradiation device 1. Note that the drive unit 150 may be provided outside the laser beam irradiation device 1 and the arm 116 may be connected to the drive unit 150 via a drive shaft. In this case, a metal wire or the like can be used as the drive shaft.

The drive unit 150 includes a cable 189
Motor 18 supplied with electric power from the drive unit power supply 3
8 are connected. The drive unit power supply 3 supplies electric power to the motor 188 at a predetermined voltage or current based on a control signal from the controller 6. As the motor 188, for example, an induction motor, a servomotor, a stepping motor, or the like can be used.

The drive unit 150 controls the emission unit 111 to
The main body 110 is reciprocated in the axial direction. Here, the drive unit power supply 3, the motor 188, and the drive unit 150
Constitutes a moving means for moving the position of the emission unit 111 in the axial direction of the main body 110. Then, the emission unit 111
The inclination angle changes with the position in the axial direction based on the interlock between the arm 116 and the groove 132.

FIG. 5 is a diagram for explaining the relationship between the movement of the emitting section and the direction of energy irradiation.

As shown in FIG. 5, the distance between the arm 116 and the non-parallel groove 132 at the position P2 is
Shorter than one. Therefore, the support part 1 of the emission part 111
When 28 moves from the position P1 to the position P2, the projection 133 of the emission unit 111 slides along the groove 132, and the inclination angle of the emission unit 111 is adjusted. That is,
The inclination angle of the emission unit 111 with respect to the axis of the main body 110 is reduced. Similarly, when the support part 128 of the emission part 111 moves from the position P2 to the position P3, the inclination angle of the emission part 111 with respect to the axis of the main body 110 is further reduced. On the other hand, at the positions P1 to P3, the emission unit 111
The laser light reflected by the laser beam concentrates on a target point 40 inside the target site 30 which is a lesion site, that is, a target heated site.

That is, the laser beam is continuously applied only to the target point 40, and is applied intermittently to other living tissues such as the surface layer. Therefore, the target point 40 is heated by the irradiated laser light,
The desired temperature is reached. On the other hand, other living tissues such as the surface layer have a short heat irradiation time, so the amount of generated heat is small,
Hardly heated. In addition, the laser beam irradiation device 1
By appropriately designing the relationship between the arm 116 parallel to the axial direction of the main body 110 and the non-parallel groove 132 and the shape of the groove 132, even for a lesion having a complicated shape,
Applicable. For example, the groove 132 is not limited to a straight line but may be a curved line.

FIG. 6 is a sectional view taken along line VI-VI of FIG.

As shown in FIG. 6, the main body 110 includes
A working lumen 121 into which the arm 116 is slidably inserted is provided. The working lumen 121 is formed parallel to the axis of the main body 110. The main body 110 further includes a lumen 122 for the optical fiber 118, a lumen 123 for the endoscope 180,
A cooling liquid injection lumen 124 and a discharge lumen 125 are provided as cooling means.

The cooling liquid is used to suppress heat generation in the housing 112 caused by the laser beam and to cool the surface of the living tissue in contact with the housing 112. The lumens 124 and 125 are respectively connected to the tubes 185 and 186 for injecting and discharging the cooling liquid of the cooling liquid supply device 4 through connectors (not shown) (see FIGS. 1 and 2).
It is connected to the. By circulating the coolant,
The cooling efficiency is improved. The temperature of the cooling liquid is not particularly limited as long as it can reduce the damage of the emission section 111 and the irradiation surface of the living tissue due to the irradiation of the laser beam, but it is preferably 0 to 3
The temperature is 7 ° C, more preferably 8 to 25 ° C, in which the possibility of frostbite is small and the cooling effect is high.

As the cooling liquid supply device 4, a roller pump, a diaphragm pump, a magnet pump, or the like can be used. As the tubes 185 and 186, a plastic tube such as a vinyl chloride tube or a silicon tube, a metal pipe such as a stainless steel pipe, or the like can be used. Good to use.

The cooling liquid sending device 4 includes a cooling liquid temperature controller 5, and the cooling liquid temperature controller 5 is connected to the cooling liquid sending device 4 by a liquid sending pipe 51. The temperature of the circulating coolant can be adjusted by the coolant temperature controller 5, and the temperature of the coolant can be adjusted to a temperature suitable for treatment. Therefore, it is not necessary to cool the cooling liquid in advance. Further, it is possible to solve the problem that the temperature of the cooling liquid fluctuates, for example, the cooling liquid that has been cooled beforehand is heated during the long-time irradiation of the laser light.

In order to prevent the coolant from flowing back toward the base end, it is preferable to provide a check valve in each of the lumens 121, 122 and 123. Any of the working lumens 121, 122, and 123 may also be used for injecting or discharging the cooling liquid, and the number of lumens may be reduced by one. It is preferable to use a sterilized liquid, preferably a physiological saline, as the cooling liquid. This is because if the coolant leaks into the body for any reason, the effect of the leak is low.

FIG. 7 is a perspective view for explaining the structure of the drive unit.

As shown in FIG. 7, the drive unit 150 for reciprocating the emission unit 111 has a groove cam 151. The groove cam 151 is provided with an elliptical groove 154. The rotation shaft 153 of the groove cam 151 is connected to the shaft of the motor 188, but does not coincide with the center of the groove 154. The drive unit 150 further has a cam follower 162 provided at the base end of a rod 156 connected to the base end of the arm 116. The cam follower 162 has the groove 1
54, is slidably fitted.

The groove cam 151 is driven by a motor 188 and is rotated around a rotation shaft 153. On the other hand, the cam follower 162 is not rotated,
It is slid along the groove 154. Rotary axis 1
53 is eccentric with respect to the center of the groove 154, so that the rod 156 and the arm 11 connected to the rod 156
6 repeats a reciprocating motion, that is, a linear motion.

FIG. 8 shows an optical fiber 118 attached to the arm 116.
FIG. 5 is a diagram showing an example in which the vicinity of the tip of the is fixed. With this configuration, since the optical fiber 118 and the arm 116 are reciprocated integrally, the tip of the optical fiber 118 irradiated with the laser beam is always kept at a constant distance with respect to the reflection surface 127. It is. In this case, an optical element for converging light may not be used at the tip of the optical fiber 118. Also, the working lumen 12 for the arm 116
The optical fiber 118 may be inserted into the tube 1 so as to double as a lumen.

FIG. 9 is a cross-sectional view for explaining an example of use of the laser beam irradiation device.

First, the distal end portion of the main body 110 is inserted into the body cavity 22, and the housing 112 in which the emission section 111 is accommodated is placed on the lesion layer, that is, the surface layer near the target section 30, which is the target heating section. Adhere. At this time, it is desirable to directly confirm the position of the housing 112 with the endoscope 180. The position of the target point 40 in the longitudinal direction of the main body 110 is
The adjustment is performed by moving the entire laser light irradiation device 1 in the longitudinal direction of the main body 110. The position of the target point 40 with respect to the circumferential direction of the main body 110 is determined by manually rotating the entire laser light irradiation device 1.
Adjusted.

Next, the laser light generator 2 is operated, and at the same time, the motor 188 is rotated. The generated laser light is introduced into the laser light irradiation device 1 via a connector (not shown).

The laser light is further guided through the optical fiber 118 from the base end to the tip end of the laser light irradiation device 1, and the reflection surface 127 of the emission part 111 in the housing 112.
And irradiates the target point 40.
The emission unit 111 has a frequency of 0.1 to 5 Hz, preferably 1 to 3 Hz.
In the cycle of, the laser beam is reciprocated in the axial direction while changing the irradiation angle. The optical path of the laser light is continuously changed, but all intersect at the target point 40.

Thus, the target point 40 inside the living tissue 20 and the vicinity thereof are heated by the irradiated laser beam to reach a desired temperature. On the other hand, the irradiation time of the laser beam on the region above the target portion 30 located on the upper side of FIG. 9, for example, the surface layer 21 of the living tissue 20, is short, and the amount of generated heat is small. Similarly, the irradiation time of the laser beam to the region below the target portion 30 located on the lower side of FIG. 9 is short, and the amount of generated heat is small.

That is, since the laser light from the emission position that moves continuously concentrates on the target point 40, the surrounding area (normal tissue) other than the target area 30 is maintained at a relatively low temperature, and the influence of the laser light is maintained. Protected from. Since the damage of the area other than the target site 30 is prevented or reduced, the laser beam irradiation device 1 has high safety for the patient. In particular, the target site 30
However, even when it is present at a deep position in the living tissue, the surface layer is prevented from being damaged, which is advantageous. In addition, a desired region is heated by changing the position of the target point 40 and irradiating the target with the laser light.

The laser beam emitted from the emission unit 111 can be divergent light, parallel light, or convergent light. When divergent light is used, the numerical aperture is 0.4 or less, preferably 0.3 or less.

The laser beam emitted from the emission unit 111 is
In the case of the parallel light or the convergent light, the convergence is good, and the energy density of the laser light at the target point 40 and its vicinity can be increased. In other words,
The energy density of the laser light composed of parallel light or convergent light and the energy density of the laser light composed of divergent light,
When the same is set at the target point 40, the former energy density is lower than the latter at the surface layer. Therefore,
Laser light composed of parallel light or convergent light can more reliably prevent damage to the surface layer than laser light composed of divergent light.

The laser beam emitted from the emission unit 111 is
In the case of convergent light, it is preferable that the target point 40 and the focal position of the laser light, that is, the position perpendicular to the axis of the laser light exhibit the minimum area coincide with each other. In this case, since the focal point of the laser beam overlaps at the target point 40, the energy density of the laser beam is reduced at the target point 40 and its vicinity.
Can be even higher.

In order to make the laser light emitted from the emission section 111 into convergent light, an optical system for turning the laser light into convergent light is provided in the optical path of the laser light. Laser light irradiation device 1
In the above, the lens constituting the optical system is
18 at the tip. In addition, the emission part 1
By configuring the reflection surface 127 of the eleventh surface with a concave mirror, the emission part 111 can also have the function of an optical system.

The laser light to be used is not particularly limited as long as it has a depth of a living body. However, the wavelength of the laser light is 750 to 1300 nm or 1600 to 18
It is preferably about 00 nm. This is because in these wavelength ranges, laser light has particularly excellent biological penetration. That is, since the surface layer of the living tissue absorbs only a small amount of the energy of the irradiated laser light, the laser light is more effectively applied to the target portion 30 located deep in the living tissue.

For example, gas lasers such as He-Ne lasers, solid-state lasers such as Nd-YAG lasers, GaAlAs
A semiconductor laser such as a laser can be applied to the laser light generator 2 that generates laser light in the above wavelength range.

The diameter of the insertion portion of the laser beam irradiation device 1, that is, the outer diameter of the main body 110 is not particularly limited as long as it can be inserted into the body cavity 22. However, the outer diameter of the main body 110 is
It is preferably about 2 to 20 mm, more preferably about 3 to 8 mm.

As the constituent materials of the main body 110, polycarbonate, acrylic, polyolefin such as polyethylene and polypropylene, ethylene-vinyl acetate copolymer (EV
A), a polymer alloy containing any one of materials such as polyvinyl chloride, polyester such as polyethylene terephthalate and polybutylene terephthalate, polyamide, polyurethane, polystyrene and fluororesin, or a substance in which two or more materials are combined, No.

A lubricating coating layer having a low friction material such as silicon or fluororesin or a hydrophilic polymer material may be formed on the surface of the main body 110. In this case, the surface friction of the main body 110 is reduced.
10 is smoothly inserted into the body cavity. Further, a lubricating coating layer may be formed on a surface of a disposable sheath that is separately prepared and covers the main body 110. In this case, it is possible to prevent the adverse effects caused by the use a plurality of times, that is, the loss of the lubricity due to the peeling of the lubricating coating layer.

The hydrophilic polymer material used for the lubricating coating layer is, for example, carboxymethyl cellulose, polysaccharide, polyvinyl alcohol, polyethylene oxide, sodium polyacrylate, methyl vinyl ether-maleic anhydride copolymer, water-soluble Polyamide is preferred,
Methyl vinyl ether-maleic anhydride copolymer is particularly preferred.

When a laser beam irradiation device having a main body coated with a hydrophilic polymer material is used, the main body is immersed in, for example, physiological saline. This wets the surface layer of the body and the device has lubricity. That is, when the device has a surface layer containing a hydrophilic polymer material, the frictional resistance between the living tissue and the device is reduced. This reduces the burden on the patient and improves safety. For example, the insertion or withdrawal of the device into or from the body cavity, and the movement or rotation of the device within the body cavity are smoothly performed.

The housing 112 is made of quartz glass, acrylic, polystyrene, polycarbonate, polyethylene,
It is desirable to form from a material having excellent laser light transmission properties, such as polypropylene, vinylidene chloride, polyester such as polyethylene terephthalate and polybutylene terephthalate. Note that the entire housing 112 does not need to be formed of a material having laser light transmittance, and may be only a window for laser light irradiation. When the window for laser light irradiation is formed of a material having laser light transmittance, laser light can be efficiently irradiated. It is also possible to form a window for laser light irradiation with an opening and form the cover member 113 that covers the housing 112 using the above-described material.

The energy transmission member is not limited to an optical fiber, but may be a member capable of guiding laser light, for example, a rod lens. The emission part is not limited to a plate having a smooth reflection surface, and for example, a prism and a wedge plate can be applied.

As shown in FIG. 1, the above-mentioned laser beam generator 2, drive unit power supply 3, coolant supply device 4, and coolant temperature controller 5 are connected to a controller 6, respectively. Further, the controller 6 includes an input unit 8 including various input keys and the like used when setting treatment conditions for performing the heat treatment, and a display means for displaying input information, calculation results, and the like through the input unit 8. And other input / output devices (not shown) are connected. The controller 6 controls overall control of the heat treatment apparatus 10. Note that the controller 6, the monitor 7, the input unit 8, and the memory 9 described later are collectively arranged to form the control unit 11, so that the entire heat treatment apparatus can be made compact.

The heat treatment apparatus 10 of the present embodiment predicts the temperature and the position of the living tissue to be heated corresponding to each other, based on the treatment conditions for performing the heat treatment set through the input unit 8. The unit 12 is connected to the controller 6
Have in.

As a prediction method by the prediction unit 12, the input information about the treatment condition input to the input unit 8 is substituted into, for example, a relational expression obtained in advance experimentally and stored in the memory 9, and A method of calculating and obtaining mutually corresponding temperatures and positions is adopted. However, a method using a function table previously obtained experimentally may be used.

FIG. 10 is a flowchart showing a method for predicting and displaying the temperature and the position of the living tissue to be heated corresponding to each other.

When using a heat treatment apparatus,
First, a lesion site of a patient is diagnosed in advance. Diagnosis of the lesion site can be done by visual inspection, palpation,
Examination by percussion and auscultation, optical endoscope, ultrasonic endoscope, X
X-ray imaging, magnetic resonance imaging (MRI)
imaging), computer-assisted tomography (CT) using X-ray or magnetic resonance, positron emission tomogr (PET)
aphy), single-photon emission computer-assisted tomography (SP
ECT; single photon emission computed tomograph
This is performed by image diagnosis, biopsy, etc. according to y).

Then, the operator determines a target site, which is a target heating site, from the lesion site grasped by the diagnosis, and inputs treatment conditions for performing the heating treatment through the input unit 8 (S11). .

The treatment conditions include laser light output, laser light irradiation time, cooling liquid temperature, cooling liquid flow rate, and moving speed of the laser light emitting section.

The prediction unit 12 of the controller 6
Based on the treatment conditions input through the, the temperature and position of the heated living tissue corresponding to each other are predicted using the relational expression stored in the memory 9 (S12).

Next, the controller 6 displays the predicted temperature and position of the living tissue corresponding to each other on the monitor 7 (S13). The operator inputs new treatment conditions again through the input unit 8 with reference to the display value on the monitor 7. By appropriately repeating such operations, the surgeon can search for a treatment condition at which a desired position has a desired temperature.

At the stage where the treatment conditions are determined, the operator inputs the start of treatment through the input unit 8. Controller 6
Controls the laser light generator 2, the drive unit power supply 3, the coolant supply device 4, and the coolant temperature controller 5 so as to match the treatment condition input by the operator. Here, as the treatment condition not included in the items input through the input unit 8, a general value in the heat treatment is adopted, and the prediction unit 12 performs prediction in consideration of this point.

As described above, the heat treatment apparatus 1 of the present embodiment
0 indicates that when the operator sets and inputs a treatment condition, the temperature and position of the living tissue to be heated corresponding to each other are predicted and displayed, so that the operator can confirm that the set treatment condition is correct. Confirmation can be made before treatment, and insufficient or excessive irradiation of laser light can be prevented. Therefore,
According to the condition of each patient, it is possible to accurately and easily heat only the lesion site while preventing damage to normal tissues around the lesion site.

FIG. 11 is a sectional view of a living tissue, and FIG.
It is a flowchart which made FIG. 10 more concrete. Therefore, a description of a part overlapping with the above description is partially omitted.

In the method shown in FIG. 12, the position of the highest temperature in the heated living tissue and the highest temperature are predicted. As shown in FIG.
It is indicated by the distance D (mm) from the laser light emitting end 111a to the point where the temperature reaches the maximum. In the case of the laser beam irradiation device 1 shown in FIG. 1, since the emission end 111 a is in contact with the surface layer 21 of the living tissue 20, the distance D is set so that the distance from the surface of the surface layer 21 to the highest temperature in the living tissue. Is the same as the distance to

When using a heat treatment apparatus,
First, a lesion site of a patient is diagnosed in advance. From the lesion site grasped by the diagnosis, the operator determines a target site which is a target heating site, and inputs a treatment condition for performing the heating treatment through the input unit 8. That is, the output p (W) of the laser light and the irradiation time t of the laser light
(Second), coolant temperature c (° C.), coolant flow rate q (ml
/ Min) through the input unit 8 (S21 to S2).
4).

The input of the treatment condition is performed, for example, by directly inputting the numerical value of the output of the laser beam through the input unit 8. However, a plurality of typical numerical values may be set in advance, and the numerical value may be selected from the numerical values.

The prediction unit 12 of the controller 6
The output end 111a, that is, the surface layer 2, is based on the treatment conditions input through the system, namely, the output p of the laser light, the irradiation time t of the laser light, the temperature c of the coolant, and the flow rate q of the coolant.
The distance D (mm) from the surface 1 to the point of the highest temperature in the living tissue and the highest temperature T (° C.) are predicted using the relational expression stored in the memory 9 (S25). .

Next, the controller 6 displays the predicted maximum temperature T (° C.) of the living tissue and its position D (mm) on the monitor 7 (S26). At this time, the input information on the treatment condition input to the input unit 8 may also be displayed on the monitor 7 together.

The operator again inputs new treatment conditions through the input unit 8 with reference to the predicted maximum temperature T (° C.) of the living tissue and its position D (mm) displayed on the monitor 7. , Can find the appropriate treatment conditions.

At the stage when the treatment condition is determined, the operator inputs the start of treatment through the input unit 8. Controller 6
Controls the laser light generator 2, the drive unit power supply 3, the coolant supply device 4, and the coolant temperature controller 5 so as to match the treatment condition input by the operator. Here, the treatment condition not included in the items input through the input unit 8, that is, the moving speed of the laser light emitting unit is a general value in the heat treatment, and in consideration of this,
The maximum temperature of the living tissue and its position are predicted.

As described above, according to the method shown in FIG. 12, the operator can output laser light p (W), laser light irradiation time t (second), cooling liquid temperature c (° C.), Just by setting and inputting the flow rate q (ml / min) of the cooling liquid, the operator estimates and displays the position of the highest temperature in the heated living tissue and the highest temperature. Before the treatment, it can be confirmed that the treatment conditions such as the output p of the laser light thus applied are not erroneous, that is, that the laser irradiation by the heat treatment device and the cooling of the surface layer of the living tissue are performed well. Shortage or excessive irradiation of the laser beam can be prevented.

In the method shown in FIG.
The items input through are the laser light output p (W),
Laser light irradiation time t (second), cooling liquid temperature c (° C.),
Although the flow rate of the cooling liquid is q (ml / min), the present invention is not limited thereto. For example, the item input through the input unit 8 can include the moving speed of the laser light emitting unit. In addition, items selected and combined from the above-described items as appropriate may be items input through the input unit 8.

When the temperature of the tissue predicted by the prediction unit 12 exceeds a predetermined temperature, the controller 6 prohibits the irradiation of the laser beam or warns the operator. Is also good. In this way, it is possible to set and input a treatment condition, and if the maximum temperature of the tissue to be heated is predicted to be inappropriately high, it is possible to avoid the irradiation of laser light. It is possible to prevent a situation in which a person mistakenly starts treatment as it is and performs excessive irradiation with laser light.

FIGS. 13 to 16 show the results of experiments in which the temperature distribution of a tissue heated using the heat treatment apparatus of the present invention was measured. FIG. 17 shows the results of experiments under various treatment conditions and the like. 5 is a table showing predicted values, actual measured values, and errors by a prediction unit.

The experiments shown in FIGS. 13 to 17 were performed using the heat treatment apparatus 10 shown in FIG. However, in the laser beam irradiation apparatus 1 used in the experiment, the arm 116 and the optical fiber 118 are fixed near the tip of the optical fiber, and the arm 1
The optical fiber 16 and the optical fiber 118 are configured to move integrally. In addition, a balloon (see balloon 230 in FIG. 18) that can cool the surface of the tissue to be irradiated with the laser beam is provided at the distal end of the main body 110. The outer diameter of the balloon when inflated is 8 mm.

The experiment was performed under the following conditions.
Heated object: Kamaboko phantom Laser light: wavelength 810 nm, continuous wave, beam diameter 4 mm on tissue surface, numerical aperture NA = 0.26 Environmental temperature: room temperature 22 ° C. Moving speed of laser beam emission part: 3 reciprocations / second Movement length of laser beam emitting section: 20 mm Laser beam crossing depth: 15 mm Laser light output: 3 to 10 W Laser light irradiation time: 0 to 500 seconds Coolant temperature: 0 to 30 ° C Coolant flow rate: 100 to 300 (ml / min).

Further, the output items p (W) of the laser light and the irradiation time t of the laser light, which are items input through the input section 8, are provided.
(Second), coolant temperature c (° C.), and coolant flow rate q
The experimentally determined relational expression used to determine the maximum temperature T (° C.) of the living tissue and its position D (mm) from (ml / min) is as follows.

T = T0 + {p × ka− (T0−c) × kb} × ln (t + 1) (1) D = p × kc + t × kd + (T0−c) × ke + q × kf ( 2) Here, T0 is the tissue temperature (° C.), ka (heating coefficient) = 0.15, kb (cooling coefficient) = 0.0073, k
c (output coefficient) = 0.095, kd (time coefficient) = 0.
006, ke (temperature coefficient) = 0.196, and kf (flow coefficient) = 0.010.

When the object to be heated is a living body, the tissue temperature T0 (° C.) is usually around 37 ° C., and thus need not be input. However, even when the object to be heated is a living body, the tissue temperature T0 may of course be input. In this experiment, the average value of the temperatures at a plurality of points before the laser light irradiation of the phantom was used as the tissue temperature T0.

As shown in the column of treatment conditions and the like in FIG.
In this experiment, No. 1 to No.
13 experiments were conducted. The heating target was heated under the treatment conditions and the like set as described above, and the temperature distribution of the heated target was measured from the tissue surface to a depth of 20 mm. FIG. 13 shows the results of Experiment Nos.
FIG. 14 shows the relationship between the output of the laser beam and the tissue temperature distribution from the results of No. 3, and FIG. 14 shows the relationship between the laser beam irradiation time and the tissue temperature distribution from the results of Experiments No. 2 and Nos. 4 to 6. FIG.
FIG. 16 shows the relationship between the coolant flow rate and the tissue temperature distribution from the results of Experiment Nos. 2 and 7 to No. 9, and FIG.
From the results of Nos. 10 to 13, the relationship between the coolant temperature and the tissue temperature distribution is shown.

The column of predicted values in FIG. 17 is obtained by substituting the numerical values shown in the columns of the treatment conditions and the like into the above equations (1) and (2). On the other hand, the column of measured values in FIG. 17 is obtained from the measurement results of the temperature distribution of the heated tissue shown in FIGS.

Referring to FIG. 17, for the maximum temperature of the heated tissue, the error between the predicted value and the actually measured value is at most 0.
It was 4 ° C., and in all of the experiments No. 1 to No. 13 performed, it could be judged that the prediction of the maximum temperature of the heated tissue was sufficiently possible. In addition, the error between the predicted value and the actually measured value is 1.0 m at the maximum at the position where the temperature is highest.
m, and in all of the experiments No. 1 to No. 13 performed, it was determined that the prediction of the position where the temperature reached the maximum was sufficiently possible.

The heat treatment apparatus of the present invention heats normal tissues of the urethra and rectum near the prostate to a predetermined temperature or higher, such as prostate diseases such as benign prostatic hyperplasia and prostate cancer. It is particularly preferable to apply this method when only the inside of the prostate is heated to a temperature higher than a preset temperature.

The embodiments described above are not described to limit the present invention, and various modifications can be made by those skilled in the art within the technical concept of the present invention.

For example, in the heat treatment apparatus according to the above-described embodiment, as the specific example of the temperature and the position of the heated living tissue corresponding to each other predicted by the prediction unit 12, the highest temperature among the heated living tissue is used. Although the position at which the temperature is reached and the maximum temperature have been described, the present invention is not limited to this.

For example, the prediction unit 12 determines not only the maximum temperature and the position where the maximum temperature is reached, but also the biological body to be heated by experimentally obtaining relational expressions for prediction at various positions of the living tissue. It is also possible to predict the temperature distribution within a predetermined range of the tissue, specifically, for example, the entire organ to be a heating target, and display the image on the monitor 7. Further, for example, the prediction unit 12 predicts a range (for example, a range of 45 ° C. or more) corresponding to a temperature equal to or higher than a predetermined value in the tissue, and displays the image on the monitor 7 or displays the surface layer 21 of the range. The shortest distance and the longest distance measured in the depth direction from the surface may be displayed numerically. By doing so, it is possible to obtain not only the same effects as in the above-described embodiment, but also to more reliably prevent damage to normal tissues around the lesion site.

Further, the above-mentioned relational expressions (1) and (2) used in the calculation for the prediction used in Experiment Nos. 1 to 13 hold only under the relevant experimental conditions, and Only. In actual treatment, the permeability of laser light differs depending on the living tissue, and the influence of heat diffusion due to blood flow is added.Therefore, the relational expression for predicting the maximum temperature and the prediction of the position where the maximum temperature is reached. Are different from the above-mentioned relational expressions (1) and (2). Note that, even when the above relational expressions (1) and (2) are approximately used, the values of the coefficients ka to kf generally differ.

The laser beam irradiation device of the heat treatment apparatus is not limited to the structure shown in FIG. 3, but a long insertion portion is inserted into a living body, and an emission portion provided at the insertion portion is provided. From, in addition to those that irradiate the living body tissue with laser light, a part that is surgically pressed against the living tissue is pressed, or a part that is pressed against the body surface is pressed against the body surface, and installed on the pressed part. Various laser light irradiation devices such as those that irradiate the living tissue with laser light from the emitting section can be used.

FIG. 18 is a sectional view of a tip portion of another example of the laser beam irradiation device. The description of the common points with the laser beam irradiation apparatus shown in FIG. 3 will be omitted, and the main differences will be described. This laser light irradiation device 1a includes an emission unit 2 having a concave reflecting surface 227 that reflects laser light.
And the laser light transmitted by the optical fiber 218 is converged. The optical fiber 218 and the arm 216 are inserted into the tube 237 and are fixed to each other. Therefore, since the optical fiber 218 and the arm 216 are reciprocated integrally, the tip of the optical fiber 218 irradiated with the laser beam always keeps a constant distance with respect to the reflection surface 227, and The shape is also kept constant.

The laser beam irradiation device 1a further has a balloon 230 that expands or contracts. The balloon 230 surrounds a housing 212 disposed at the distal end of the main body 210. The balloon 230 is preferably made of a material having excellent laser light transmittance, such as polyolefin, polyester, polyamide, latex, and cellulose. This is because the energy absorbed by the balloon 230 when the laser light passes through the balloon 230 and the temperature rise caused by the absorbed energy can be reduced. Balloon 23
The working fluid that expands 0 is supplied using a cooling liquid injection and discharge lumen. One end of the lumen is connected to a tube for injecting and discharging the cooling liquid of the cooling liquid sending device 4 via a connector (not shown), and the other end is connected to the balloon 230. When the working fluid is a cooling liquid, it is preferable to circulate the working fluid in order to improve the cooling efficiency. However, it is also possible to adopt a configuration in which the cooling liquid is not circulated. Balloon 230
The position and orientation of the laser beam irradiation device 1a are fixed by the expansion of the laser beam irradiation device 1a. In addition, since the portion in contact with the balloon 230 and its vicinity, that is, the surface layer of the living tissue is further cooled by the working fluid, the surface layer can be more reliably prevented from being damaged.

Since the living tissue is expanded by inflating the balloon 230, the distance from the laser light emitting portion 211 to the surface of the surface layer 21 of the living tissue 20 changes. Therefore, the predicted position may be corrected as necessary in consideration of the balloon diameter at the time of inflation. However, as shown in FIG. 19, the balloon 230 can be formed so as to surround the entire periphery of the housing 212 except for a window for laser beam irradiation. In this case, when the balloon 230 is inflated, the emission end, which is a window for laser light irradiation, of the main body 210 is brought into contact with the surface of the surface layer 21 of the living tissue 20 to be irradiated with the laser light. Since the distance from the surface to the surface of the surface layer 21 of the living tissue 20 to which the laser light is irradiated is constant, it is not necessary to correct the predicted position.

The laser beam irradiating apparatus can be used in addition to the above.
Various laser light irradiation devices can be used. For example, the emission unit 111 illustrated in FIGS. 3 and 4 includes a support unit 128 on one side and a pair of protrusions 133 on the other side. However, as illustrated in FIG. Are provided on both sides opposite to each other, and each support 328, 329 is provided with a separate arm 316, 317, respectively.
And a pair of arms 316 and 31
The irradiation angle of the emission unit 311 may be changed by reciprocating the actuator 7 in the axial direction with different strokes by the respective drive units. in this case,
Since the projection for engagement is not provided on the light emitting portion 311, the groove disposed on the inner wall of the housing is unnecessary. Further, by providing an adjuster (not shown) for adjusting the relative length of each of the arms 316 and 317, the angle change range of the emission unit 311 can be changed.

The laser beam irradiation device may be one in which the position of the laser beam emitting portion is fixed without moving in the axial direction of the main body during the operation of the device. A laser beam irradiating device having a fixed beam emitting unit has a plurality of beam emitting units, and the irradiation range of the laser beam from each beam emitting unit overlaps at a lesion site. Includes those that irradiate tissue.

Also, as the energy applied to the living tissue, a laser beam has been described as an example.
The present invention is not limited to this. The present invention
The present invention can also be applied to a heat treatment apparatus that irradiates living tissue with energy such as microwaves, radio waves, and ultrasonic waves to perform heat treatment.

[0109]

As described above, according to the present invention, the temperature and the position of the living tissue to be heated corresponding to each other are predicted on the basis of the treatment conditions set by the operator. Can confirm before treatment that the set treatment conditions are correct, and can prevent insufficient or excessive irradiation of energy. Therefore, it is possible to accurately and easily heat only the lesion site while preventing damage to the normal tissue around the lesion site in accordance with each patient's disease state.

[Brief description of the drawings]

FIG. 1 is a system configuration diagram of a heat treatment apparatus according to an embodiment of the present invention.

FIG. 2 is a perspective view of a laser beam irradiation device.

FIG. 3 is a cross-sectional view of a tip portion of the laser light irradiation device.

FIG. 4 is a perspective view for explaining a structure of an emission unit and an arm of the laser light irradiation device.

FIG. 5 is a diagram for explaining the relationship between the movement of the emission unit and the energy irradiation direction.

FIG. 6 is a sectional view taken along line VI-VI in FIG. 3;

FIG. 7 is a perspective view for explaining the structure of a drive unit of the laser beam irradiation device.

FIG. 8 is a diagram showing an example in which the vicinity of the tip of an optical fiber is fixed to an arm.

FIG. 9 is a cross-sectional view illustrating an example of use of the laser beam irradiation device.

FIG. 10 is a flowchart showing a method for predicting and displaying mutually corresponding temperatures and positions of a living tissue to be heated.

FIG. 11 is a sectional view of a living tissue.

FIG. 12 is a flowchart more specifically showing FIG. 10;

FIG. 13 is a view showing a result of measuring a temperature distribution of a heated tissue.

FIG. 14 is a diagram showing a result of measuring a temperature distribution of a heated tissue.

FIG. 15 is a diagram showing a result of measuring a temperature distribution of a heated tissue.

FIG. 16 is a diagram showing a result of measuring a temperature distribution of a heated tissue.

FIG. 17 shows the results of experiments under various treatment conditions and the like.
4 is a chart showing a predicted value, an actually measured value, and an error by a prediction unit.

FIG. 18 is a sectional view of a tip portion of another example of the laser beam irradiation device.

FIG. 19 is a view of a laser beam irradiation device provided with a balloon as viewed from the distal end side.

FIG. 20 is a perspective view for explaining another example of the structure of the emission section and the arm of the laser beam irradiation device.

[Explanation of symbols]

1, 1a: laser beam irradiation device, 110, 210: body (insertion section), 111, 211, 311: emission section, 116, 216, 316, 317: arm (interlocking means), 132, 232 ... groove (interlocking means) ), 150: drive unit (moving means), 188: motor (moving means), 2: laser beam generator, 3: drive unit power supply (moving means), 4: coolant liquid feeder, 5: coolant temperature adjustment 6: Controller, 7: Monitor (display means), 8: Input unit, 10: Heat treatment device, 12: Predictor (predictor), 20: Living tissue.

──────────────────────────────────────────────────続 き Continued on the front page (51) Int.Cl. ⁷ Identification symbol FI Theme coat ゛ (Reference) A61N 5/02 A61B 17/36 330 5/06 340 350 F Term (Reference) 4C026 AA04 BB04 BB07 BB08 DD03 FF56 GG03 GG06 HH04 HH05 HH13 HH24 4C060 JJ15 JJ17 JJ24 JJ25 JJ27 KK47 4C061 AA15 BB00 CC00 DD00 HH56 JJ17 4C082 MC05 ME03 ME17 ME18 MG03 MG05 RA02 RC03 RC08 RC09 RE24 RG03 RJ06 RL04 A0313 01

Claims (10)

[Claims] 1. Irradiating energy to a living tissue,
In a heat treatment device that performs heat treatment, based on treatment conditions set for performing heat treatment,
A heat treatment apparatus comprising a predicting unit for predicting a temperature and a position of a living tissue to be heated corresponding to each other. 2. The heat treatment apparatus according to claim 1, further comprising display means for displaying a result predicted by said prediction means. 3. The heat treatment apparatus according to claim 1, wherein the predicting unit predicts a position of the living tissue to be heated which has the highest temperature and the highest temperature. 4. The heat treatment apparatus according to claim 1, wherein the prediction unit predicts a temperature distribution within a predetermined range of the living tissue to be heated. 5. The heat treatment according to claim 1, wherein when the temperature exceeds a predetermined temperature set in advance, the energy irradiation is prohibited or a warning is given to an operator. apparatus. 6. An elongate insertion portion that can be inserted into a living body, and energy is emitted toward living tissue from an emission portion provided in the insertion portion.
6. The heat treatment apparatus according to any one of 5 above. 7. The heat treatment apparatus according to claim 6, further comprising cooling means for cooling the emission unit and an energy irradiation surface of the living tissue. 8. A moving means for moving the position of the emission section in the axial direction of the insertion section, and changing an emission angle of energy emitted toward living tissue with the movement of the emission section in the axial direction. The heat treatment apparatus according to claim 6, further comprising: interlocking means. 9. The heat treatment apparatus according to claim 1, wherein the energy is a laser beam. 10. The treatment conditions set for performing the heat treatment include the output of the energy, the irradiation time of the energy, the temperature of the coolant when the coolant is used, and the cooling when the coolant is sent. 10. One or two or more items selected from the group consisting of a flow rate of a liquid and a moving speed of an emission part when moving an emission part for irradiating energy. The heat treatment apparatus according to any one of the above.