The present invention relates to a light irradiation treatment instrument that guides optical energy into a body cavity as therapeutic light and irradiates a lesion part or the like with the therapeutic light and an operation method for the light irradiation treatment instrument.
In recent years, in a medical field, PDT (photodynamic therapy), PIT (photoimmuno therapy), and the like have been studied as methods of treatment for killing cancer cells using optical energy.
For example, as disclosed in Japanese Patent No. 6127045, PIT includes a step of bringing a therapeutically effective amount of antibody molecules into contact with a cell having cell surface protein, a step of specifically combining antibodies with cell surface protein such as a tumor-specific antigen on a surface of a tumor cell, and a step of irradiating a cell with optical energy such as a laser beam to break up a cell membrane.
As a technique for irradiating, with PDT treatment or the like, a hollow organ such as a bladder with light, for example, Japanese Patent Application Laid-Open Publication No. S59-95065 discloses a technique for, on an inside of a hollow organ such as a bladder, expanding a balloon provided at a distal end of a catheter with a scattering medium and uniformly irradiating, with the scattering medium, a hollow organ inner wall surface with light from a light guide (a light irradiation treatment instrument).
A lesion in a bladder tends to often occur in a connecting portion to a urethra where urine easily accumulates. Therefore, when the bladder is treated by PDT or PIT, it is desirable to irradiate not only an inside of the bladder but also a urethra portion (a proximal urethra portion) with optical energy.
A light irradiation treatment instrument according to an aspect of the present invention includes: an insertion member insertable into an inside of a living body; a positioning unit disposed between a first end and a second end of the insertion member and capable of positioning the insertion member with respect to the living body; and a light radiating unit disposed between the first end and the second end and configured to radiate therapeutic light toward an outer side, intensity of the therapeutic light being different between a side closer to the first end than the positioning unit and a side closer to the second end than the positioning unit.
A light irradiation treatment instrument according to another aspect of the present invention includes: a catheter main body having translucency and being insertable into a conduit and an inside of a hollow organ communicating with the conduit; a balloon having translucency and being provided in the catheter main body and configured to expand to thereby position the catheter main body with respect to the conduit and the hollow organ; and an optical fiber having a predetermined length in a longitudinal direction, a first light radiating unit capable of radiating therapeutic light having first intensity and a second light radiating unit connected consecutively to the first light radiating unit in the longitudinal direction and capable of radiating the therapeutic light having second intensity different from the first intensity being formed on a distal end side, the optical fiber guiding the therapeutic light to the first light radiating unit and the second light radiating unit. When the optical fiber is inserted, the catheter main body positioned by the balloon positions one of the first light radiating unit and the second light radiating unit on an inside of the hollow organ and positions another one of the first light radiating unit and the second light radiating unit on an inside of the conduit and a joint portion of the conduit and the hollow organ.
An operation method for a light irradiation treatment instrument according to an aspect of the present invention includes: inserting a catheter main body into a conduit and an inside of a hollow organ communicating with the conduit; positioning the catheter main body with respect to the conduit and the hollow organ; inserting an optical fiber into an inside of the catheter main body, the optical fiber having a predetermined length in a longitudinal direction, a first light radiating unit capable of radiating therapeutic light having first intensity and a second light radiating unit connected consecutively to the first light radiating unit in the longitudinal direction and capable of radiating therapeutic light having second intensity different from the first intensity being formed on a distal end side; and, with respect to the catheter main body, positioning one of the first light radiating unit and the second light radiating unit on an inside of the hollow organ and positioning another one of the first light radiating unit and the second light radiating unit on an inside of the conduit and a joint portion of the conduit and the hollow organ.
Embodiments of the present invention are explained below with reference to the drawings.
A laser treatment system 1 functioning as the optical treatment system shown in
The laser treatment system 1 includes a light irradiation treatment instrument 5 inserted into a living body (for example, a bladder) to irradiate a diseased part of the living body with therapeutic light, a fluid supply apparatus 6 for supplying fluid to the light irradiation treatment instrument 5, and a light source apparatus 7 for supplying therapeutic light such as a laser beam to the light irradiation treatment instrument 5.
The light irradiation treatment instrument 5 includes a catheter 10 functioning as an insertion member insertable into an inside of a living body (for example, into a urethra 50 and a bladder 51) and an optical fiber 11 inserted into the inside of the living body via the catheter 10 to irradiate a diseased part of the living body with therapeutic light.
The catheter 10 in the present embodiment is, for example, a disposable catheter for urinary organs, both ends in a longitudinal direction of which are set as a first end and a second end. The catheter 10 includes an elongated catheter main body 15 having flexibility and having a transparent characteristic with respect to therapeutic light emitted from the optical fiber 11.
The catheter main body 15 is configured by, for example, a multi-lumen tube including a first conduit 16 into which the optical fiber 11 is insertable and a second conduit 17 capable of allowing fluid such as air to flow therethrough.
At a distal end portion of the catheter main body 15, a distal end of the first conduit 16 is closed and a distal end of the second conduit 17 is opened to a side.
A balloon 18 is provided at the distal end portion of the catheter main body 15. The balloon 18 is formed in a bag shape and is disposed at the distal end portion of the catheter main body 15 in a position where the balloon 18 covers a distal end opening section 17a of the second conduit 17.
An opened end portion of the balloon 18 is liquid-tightly fixed to an outer circumferential surface of the catheter main body 15 by not-shown bobbin bonding or the like.
A closed space communicating with the distal end opening section 17a of the second conduit 17 is formed at the distal end portion of the catheter main body 15 by the balloon 18 fixed in this way.
The balloon 18 is formed by an elastic body such as rubber having a transparent characteristic with respect to the therapeutic light emitted from the optical fiber 11.
A pipe sleeve 19 is connected to a proximal end side of the catheter main body 15. In the pipe sleeve 19, a treatment instrument insertion port 19a communicating with the first conduit 16 and a connector section 19b communicating with the second conduit 17 are provided.
The fluid supply apparatus 6 of a pump type is connected to the connector section 19b, for example, via a fluid conduit 8. A pump driving switch 6a is provided in the fluid supply apparatus 6.
When a distal end portion of the catheter 10 is inserted into an inside of the bladder 51 through the urethra 50 and the pump driving switch 6a is turned on, the fluid supply apparatus 6 compresses the fluid such as air and supplies the fluid into the second conduit 17 of the catheter main body 15. Consequently, the fluid supply apparatus 6 is capable of expanding the balloon 18 (see
The fluid supply apparatus 6 in the present embodiment is set to supply, to the balloon 18, the fluid in a constant amount set by an experiment, a simulation, or the like in advance.
More specifically, an amount of the fluid supplied from the fluid supply apparatus 6 to the balloon 18 is set to, for example, an amount appropriate for the balloon 18 to extend the bladder 51 with expansion and stretching wrinkles of an inner wall of the bladder 51.
By expanding the balloon 18 with the preset constant amount of the fluid in this way, it is possible to always extend the inside of the bladder 51 to a constant volume with the balloon 18.
The expanded balloon 18 comes into contact with the inner wall of the bladder 51 over substantially an entire surface, whereby a fixed portion of the balloon 18 to the catheter main body 15 is pressed against a vicinity of a joint portion of the bladder 51 and the urethra 50. Consequently, the catheter 10 is positioned with respect to the bladder 51 or the like based on the fixed portion of the balloon 18. In other words, the catheter 10 is positioned such that the distal end portion of the catheter main body 15 is always disposed on the inside of the bladder 51 by a preset amount. In this way, the balloon 18 realizes a function of a positioning member for positioning the catheter 10. The fixed portion of the balloon 18 realizes a function of a positioning section.
The optical fiber 11 includes a core 25 and a clad 26 covering an outer circumference of the core 25. The core 25 and the clad 26 in the present embodiment is formed by, for example, quartz. Impurities for setting a refractive index of the clad 26 lower than a refractive index of the core 25 are added to the clad 26. Light is totally reflected on a boundary surface between the core 25 and the clad 26 to be guided. Note that a material configuring the core 25 and the clad 26 is not limited to the quartz. For example, resin having translucency can also be adopted.
At a distal end portion of the optical fiber 11, a light radiating unit 27 for radiating, to an irradiation target in a body cavity, therapeutic light guided from a proximal end side to a distal end side of the core 25 is provided.
The light radiating unit 27 in the present embodiment is configured by a substantially linear member having a predetermined length in the longitudinal direction, for example, in order to irradiate a region from the bladder to a urethra portion, which is an irradiation target, with the therapeutic light.
For example, as shown in
A light attenuating unit 28 made of a covering member having low transmittance is provided in an outer circumference on a proximal end side of the light radiating unit 27. Consequently, a first light radiating unit 27a and a second light radiating unit 27b having different intensities of light per unit area from each other are set.
In other words, in the light radiating unit 27, a region on a distal end side exposed from the light attenuating unit 28 is set as the first light radiating unit 27a for radiating therapeutic light to mainly a region in the bladder 51 at a large distance from the light radiating unit 27 (in an irradiation target, mainly a region of the irradiation target within a first distance range in which a shortest distance from the light radiating unit 27 is equal to or larger than a predetermined distance).
On the other hand, in the light radiating unit 27, a region on the proximal end side covered by the light attenuating unit 28 is set as the second light radiating unit 27b having the intensity of light per unit area smaller than the intensity of light per unit area of the first light radiating unit 27a. The second light radiating unit 27b is a light radiating unit for radiating therapeutic light to mainly an inside of the urethra 50 and the vicinity of the joint portion to the urethra 50 in the bladder 51 at a small distance from the light radiating unit 27 (in the irradiation target, a region of the irradiation target within a second distance range that is smaller than the first distance range and in which the shortest distance from the light radiating unit 27 is smaller than the predetermined distance).
The optical fiber 11 is inserted into the first conduit 16 and positioned with respect to the catheter 10, whereby the first and second light radiating units 27a and 27b are positioned with respect to the bladder 51 and the urethra 50.
More specifically, as explained above, the catheter 10 is positioned with respect to the bladder 51 or the like by the expanded balloon 18.
For example, the optical fiber 11 is inserted to a position where the optical fiber 11 is hit against the distal end of the first conduit 16. The optical fiber 11 is positioned with respect to the catheter 10. Note that the positioning of the optical fiber 11 with respect to the catheter 10 can also be realized by, for example, providing a mark for positioning in an outer circumference of the optical fiber 11 and positioning the mark in the pipe sleeve 19 or the like of the catheter 10.
In this way, the optical fiber 11 is positioned with respect to the catheter positioned with respect to the bladder 51 or the like. Consequently, the first and second light radiating units 27a and 27b formed in the optical fiber 11 are positioned with respect to the bladder 51 and the urethra 50 via the catheter 10.
In other words, for example, as shown in
When therapeutic light is supplied from the light source apparatus 7 explained below to the proximal end side of the optical fiber 11, the first and second light radiating units 27a and 27b are capable of irradiating surfaces (inner wall surfaces) of respective parts of the bladder 51 and the urethra 50 with therapeutic light having uniform intensity.
In other words, since the balloon 18 in the present embodiment extends the bladder 51 to the constant volume with the constant amount of the fluid, a distance from the first light radiating unit 27a disposed on an inside of the balloon 18 to the inner wall of the bladder 51 is substantially unconditionally decided. In general, since the outer circumference of the catheter 10 inserted into the urethra 50 comes into contact with the inner wall of the urethra 50, a distance from the second light radiating unit 27b to the inner wall of the urethra 50 or the like is also substantially unconditionally decided. By optimizing the intensity of the therapeutic light attenuated by the light attenuating unit 28 in the second light radiating unit 27b considering a relation among these distances, it is possible to equalize the intensity of the therapeutic light with which the surfaces (the inner wall surfaces) of the respective parts of the bladder 51 and the urethra 50 are irradiated.
The proximal end side of the optical fiber 11 configured in this way is detachably connected to the light source apparatus 7 via an optical connector 29. In other words, the proximal end side of the optical fiber 11 is fixed to the optical connector 29 in a state in which the proximal end side of the optical fiber 11 is pierced through the optical connector 29. Consequently, when the optical connector 29 is connected to the light source apparatus 7, the optical connector 29 is capable of positioning a proximal end of the optical fiber 11 in a predetermined position on an inside of the light source apparatus 7.
The light source apparatus 7 includes a laser element 7a and a laser driving unit 7b.
The laser element 7a is configured by, for example, a laser diode capable of emitting an infrared laser beam. The laser element 7a is disposed in a position opposed to, via a lens 7c, the proximal end of the optical fiber 11 positioned on the inside of the light source apparatus 7. Consequently, the laser element 7a is capable of making a laser beam functioning as therapeutic light incident on the optical fiber 11.
When a light source driving switch 7d is turned on, the laser driving unit 7b controls to drive the laser element 7a for a preset setting time. Consequently, the respective parts of the bladder 51 and the urethra 50 faced to the light radiating unit 27 are irradiated with the therapeutic light at uniform intensity. Uniform radiation energy is imparted to the respective parts of the bladder 51 and the urethra 50.
According to such an embodiment, the light radiating unit 27 provided at the distal end portion of the optical fiber 11 includes the first light radiating unit 27a having a predetermined length in the longitudinal direction and capable of radiating therapeutic light having first intensity and the second light radiating unit 27b that is connected consecutively to the first light radiating unit 27a in the longitudinal direction and radiates therapeutic light having second intensity lower than the first intensity. Consequently, even when the bladder 51, which is a hollow organ, and the urethra 50, which is a conduit, are irradiated with therapeutic light at a time, it is possible to equalize intensity of the therapeutic light with which the surfaces (the inner wall surfaces) of the respective parts are irradiated.
In other words, the intensity of the therapeutic light radiated by the first light radiating unit 27a and the intensity of the therapeutic light radiated by the second light radiating unit 27b are adjusted according to a difference between the distance from the light radiating unit 27 to the inner wall surface of the bladder 51 and the distance from the light radiating unit 27 to the inner wall surface of the urethra 50 or the like. Consequently, even when the bladder 51, which is the hollow organ, and the urethra 50, which is the conduit, are irradiated with the therapeutic light at a time, it is possible equalize the intensity of the therapeutic light with which the surfaces (the inner wall surfaces) of the respective parts are irradiated. Therefore, it is possible to impart more uniform energy in the same irradiation time to the respective parts of the bladder 51, which is the hollow organ, and the urethra 50, which is the conduit.
In this case, by expanding the balloon 18 with a preset constant amount of the fluid, it is possible to always extend the inside of the bladder 51, which is the hollow organ, to the constant volume with the balloon 18 and it is possible to unconditionally decide the distance from the first light radiating unit 27a to the inner wall surface of the bladder 51 at the time when the therapeutic light is irradiated.
When the balloon 18 is expanded in a hollow organ such as the bladder 51, the fixed portion of the balloon 18 to the catheter main body 15 is brought into contact with the vicinity of the joint portion of the bladder 51 and the urethra 50. The catheter 10 (the catheter main body 15) is positioned in the bladder 51 and the urethra 50 based on the contact of the fixed portion of the balloon 18 and the vicinity of the joint portion. By positioning the optical fiber 11 with respect to the catheter 10 positioned in this way, it is possible to accurately position the first light radiating unit 27a and the second light radiating unit 27b with respect to the bladder 51 and the urethra 50.
In the embodiment explained above, for example, as shown in
With such a configuration, if the spherical portion 27c is set to be positioned in the center of the extended bladder 51 during the expansion of the balloon 18, it is possible to irradiate the inside of the bladder 51 with the therapeutic light at more uniform intensity.
For example, as shown in
For example, by using the scattering substance as the liquid 30, it is possible to efficiently scatter the therapeutic light radiated from the first light radiating unit 27a. It is possible to radiate the therapeutic light having more uniform intensity to the respective parts in the bladder 51.
For example, as shown in
In other words, in the present modification, the first and second light radiating units 27a and 27b are realized by forming an outer circumferential surface of the core 25 with two-stage conical surfaces. More specifically, as shown in
These first and second inclination angles are set according to intensities of therapeutic light requested for the first and second light radiating units 27a and 27b and are set based on an experiment or a simulation in advance.
The outer circumferential surface is formed by the conical surface in this way. Consequently, the first and second light radiating units 27a and 27b are capable of radiating, at intensities corresponding to the inclination angles, the therapeutic light guided to the distal end side while totally reflecting in the core 25 of the optical fiber 11.
For example, as shown in
In other words, although a laser beam is made incident on only a core and guided, the laser beam is made incident on the clad 26 as well and guided.
The present modification is to form the second light radiating unit 27b using such a clad 26.
In other words, for example, as shown in
By forming the first and second light radiating units 27a and 27b using the core 25 and the clad 26 having different light amounts of the guided therapeutic light in this way, it is possible to differentiate the intensities of the therapeutic light radiated by the first and second light radiating units 27a and 27b.
For example, it is also possible to form the second light radiating unit 27b by, as shown in
For example, as shown in
In this case, the balloon 18 is formed in a tubular shape opened at both ends. A distal end side opened end portion and a proximal end side opened end portion of the balloon 18 are liquid-tightly fixed to the outer circumferential surface of the catheter main body 15 by not-shown bobbin bonding or the like in front of and behind the distal end opening section 17a of the second conduit 17.
A sealed space communicating with the distal end opening section 17a of the second conduit 17 is formed halfway on the distal end side of the catheter main body 15 by the balloon 18 fixed in this way.
In other words, in the catheter 10 in the present modification, a region on the distal end side of the catheter main body 15 is projected further to the distal end side than the balloon 18 by a predetermined amount.
Consequently, for example, as shown in
The light attenuating unit 28 is provided on the distal end side of the light radiating unit 27 in order to further attenuate intensity of therapeutic light radiated in the first light radiating unit 27a set in a region on the distal end side of the light radiating unit 27 than intensity of therapeutic light radiated in the second light radiating unit 27b set in a region on the proximal end side of the light radiating unit 27.
In the light irradiation treatment instrument 5 configured in this way, the catheter 10 is inserted through insides of the urethra 50, the bladder 51, and the urinary tract 52. The balloon 18 is expanded to the predetermined volume on the inside of the bladder 51, whereby the catheter 10 is positioned with respect to the bladder 51 and the urinary tract 52.
The optical fiber 11 is inserted into the first conduit 16 of the catheter 10 positioned in this way and is positioned with respect to the catheter 10, whereby the first light radiating unit 27a and the second light radiating unit 27b are positioned with respect to the urinary tract 52 and the bladder 51.
Therapeutic light is radiated from the first and second light radiating units 27a and 27b, whereby respective parts of surfaces (inner wall surfaces) of the urinary tract 52 and the bladder 51 are irradiated with illumination light having uniform intensity.
On the distal end side of the optical fiber 11 in the present embodiment, a part of the core 25 is projected from the clad 26. A projected region of the core 25 is set as the first light radiating unit 27a by adding a diffusing agent to the region.
In a region of the second light radiating unit 27b that irradiates a urethra, a second optical fiber 35 formed in a smaller diameter than the optical fiber 11 is wound on the outer circumference of the optical fiber 11. Since the total reflection condition is broken because the fiber is bent by the winding, light leaks to an outside without being propagated in this region. The second light radiating unit 27b is formed using this.
The proximal end side of the second optical fiber 35 is connected to the light source apparatus 7 via an optical connector 36. In other words, the proximal end side of the second optical fiber 35 is fixed to the optical connector 36 in a state in which the proximal end of the second optical fiber 35 is pierced through the optical connector 36. Consequently, when the optical connector 36 is connected to the light source apparatus 7, the optical connector 36 is capable of positioning a proximal end of the second optical fiber 35 in a predetermined position on the inside of the light source apparatus 7.
A second laser element 7e is provided on the inside of the light source apparatus 7. The second laser element 7e is disposed in a position opposed to, via a lens 7f, the proximal end of the second optical fiber 35 positioned on the inside of the light source apparatus 7. Consequently, the second laser element 7e is capable of making a laser beam functioning as therapeutic light incident on the second optical fiber 35.
The second laser element 7e is controlled to be driven by the laser driving unit 7b in synchronization with the laser element 7a. For example, an output of the first laser element 7a and an output of the second laser element 7e are adjusted such that intensity of light per unit area received by the bladder 51 or the like from the first light radiating unit 27a and intensity of light per unit area received by the urethra 50 or the like from the second light radiating unit 27b are equal.
Consequently, the second light radiating unit 27b is capable of radiating the therapeutic light in the same radiation time simultaneously with the first light radiating unit 27a.
According to such an embodiment, a system of a light source for supplying the therapeutic light to the first light radiating unit 27a and a system of a light source for supplying the therapeutic light to the second light radiating unit 27b are formed as separate systems. Consequently, it is possible to more precisely control the intensities of the therapeutic light radiated from the first and second light radiating units 27a and 27b.
For example, as shown in
In this case, for example, as shown in
The respective optical fiber sections 38a guide light to the second light radiating unit 27b. The guided light is used as light for performing treatment of the urinary tract 52 in the second light radiating unit 27b. The respective optical fiber sections 38a may not irradiate only the second light radiating unit 27b and may radiate an entire region from the proximal end side to the distal end side. The respective optical fiber sections 38a may be fixed in parallel around the optical fiber 11 as shown in
For example, as shown in
In this case, for example, as shown in
For example, as shown in
In this case, an LED driving circuit 7g for driving the LED sheet 41 is provided on the inside of the light source apparatus 7. The LED driving circuit 7g is electrically connected to the LED sheet 41 via a signal line 43.
For example, outputs of the respective LEDs 42 are set such that intensity of light per unit area received by the bladder 51 or the like from the first light radiating unit 27a and intensity of light per unit area received by the urethra 50 or the like from the second light radiating unit 27b are equal. Then, the LED driving circuit 7g is controlled by the laser driving unit 7b in synchronization with the laser element 7a. Consequently, the second light radiating unit 27b is capable of radiating therapeutic light in the same radiation time simultaneously with the first light radiating unit 27a.
In the embodiment explained above, an example is explained in which the laser driving unit 7b causes the laser element 7a and the second laser element 7e to emit light in synchronization. However, it is also possible to differentiate light emission times of the laser element 7a and the second laser element 7e.
The laser driving unit 7b is capable of performing such control, for example, according to a flowchart of a radiation control routine for therapeutic light shown in
This routine is executed by the laser driving unit 7b, for example, when the light source driving switch 7d is turned on. When the routine is started, first, in step S101, the laser driving unit 7b drives the laser element 7a and the second laser element 7e.
When proceeding from step S101 to step S102, the laser driving unit 7b checks whether a first setting time preset for the second laser element 7e has elapsed.
When determining in step S102 that the first setting time has not elapsed yet, the laser driving unit 7b stays on standby while maintaining a driving state of the laser element 7a and the second laser element 7e.
On the other hand, when determining in step S102 that the first setting time has elapsed, the laser driving unit 7b proceeds to step S103 and stops the driving of the second laser element 7e while maintaining the driving of the laser element 7a. Thereafter, the laser driving unit 7b proceeds to step S104.
When proceeding from step S103 to step S104, the laser driving unit 7b checks whether a preset second setting time has elapsed.
When determining in step S104 that the second setting time has not elapsed yet, the laser driving unit 7b stays on standby while maintaining the driving state of the laser element 7a.
On the other hand, when determining in step S104 that the second setting time has elapsed, the laser driving unit 7b proceeds to step S105, stops the driving of the laser element 7a, and, thereafter, leaves the routine.
By performing such control, it is possible to more precisely control optical energy of therapeutic light with which the respective parts are irradiated from the first and second light radiating units 27a and 27b.
The laser driving unit 7b may be realized by a computer including one or a plurality of processors, a logic circuit, a memory, an input and output interface, and a computer-readable recording medium. In that case, a program for realizing functions of respective components or an entire main body unit may be recorded in a recording medium. The functions may be realized by causing a computer system to read the recorded program and executing the program. For example, the processor is at least one of a CPU (central processing unit), a DSP (digital signal processor), or a GPU (graphics processing unit). For example, the logic circuit is at least one of an ASIC (application specific integrated circuit) or an FPGA (field-programmable gate array).
Note that the present invention is not limited to the respective embodiments explained above. Various modifications and changes are possible. The various modifications and changes are also within the technical scope of the present invention. For example, it goes without saying that the configurations of the respective embodiments and the respective modifications may be combined as appropriate.
It goes without saying that the light irradiation treatment instrument according to the present invention is also applicable to other parts in the body cavity.
This application is a continuation application of PCT/JP2018/044763 filed on Dec. 5, 2018, the entire contents of which are incorporated herein by this reference.
Number | Date | Country | |
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Parent | PCT/JP2018/044763 | Dec 2018 | US |
Child | 17235006 | US |