BALLOON CATHETER SYSTEM AND METHOD FOR OPTICAL TUMOR TREATMENT
The present invention relates to a balloon catheter system and an optical tumor treatment method in which a light energy is applied through a balloon of a balloon catheter. A lesion is resected in a surgical operation. In a transurethral resection of bladder tumor (hereinafter, referred to as TUR-Bt) for resecting a bladder tumor, for example, a perfusion liquid is flowed into the bladder, and resection of a lesion and collection of pieces of the resected lesion are performed, while ensuring a field of view of an endoscope. The bladder is expanded by the perfusion liquid, and the shape of the bladder is changed according to the content quantity of the perfusion liquid in the bladder. The document “Urological Endoscopic Surgery Procedure Illustrated Reference Book—Support for independence in transurethral operation (Non-Patent Document 1) recites, on page 108, that when the TUR-Bt is performed, if the bladder is filled with 300 ml or more of the perfusion liquid, the wall of the bladder becomes thin, which causes a tensile force to be applied to the bladder, and if electricity is conducted for resection in such a state, the bladder is likely to be damaged. Therefore, the flow rate of the perfusion liquid is required to be controlled for keeping the expanded state of the bladder constant in the TUR-Bt. On the other hand, Journal of Applied Clinical Medical Physics, Vol. 8, Nol, p55-68, Winter2007 (Non-Patent Document 2) recites the example of report that the average volume of the bladder immediately after urination is 118 milliliters. In recent years, as an effective cancer treatment method, optical treatment methods such as PDT (photodynamic therapy), PIT (photoimmuno therapy), etc., have been studied. U.S. Pat. No. 6,364,874 (referred to as Document 1), for example, discloses “Device for irradiating internal cavities of the body”. The apparatus in the Document 1 includes a flexible catheter made of a transparent material, an optical fiber designed to radially diffuse the light from a light source, and an expandable balloon fixed to one end of the catheter so as to surround a diffusion portion of the optical fiber. The balloon is made of an elastomer material that diffuses light, and manufactured, in advance, by forming based on a shape of a cavity to be treated. FIG. 1 of Document 1 illustrates an instrument for irradiating the bronchus of a patient, and FIG. 2 of Document 1 illustrates an instrument for irradiating the uterus of a patient. Each of the balloons is pressed against the wall of the cavity, and if the thickness of the surface of the balloon is constant, the pressure required for expansion is low. As a result, the balloon does not do damage on the tissues of the cavity. A balloon catheter system according to one aspect of the present invention includes: a light irradiation probe including, at a distal end portion of a fiber probe, a light irradiation portion configured to irradiate light; a balloon catheter including a shaft and a balloon, the shaft including a through hole through which the light irradiation probe is insertable, the through hole being configured to allow liquid feeding, with the light irradiation probe being arranged in the through hole, the balloon being fixed to one end portion of the shaft and configured to be expandable and contractable by a liquid injected through the through hole of the shaft; and an injection apparatus including a measuring portion configured to be capable of measuring a quantity of the liquid to be injected into the balloon, and an injection portion configured to inject the liquid measured by the measuring portion into the balloon through the through hole. The balloon expands by the liquid injected into the balloon, to thereby extend a wall of a region to be treated, and the expanded balloon retains the wall of the region to be treated in an extended state. An optical tumor treatment method according to one aspect of the present invention includes: a balloon positioning step of positioning a balloon fixed to one end portion of a shaft of a balloon catheter in a bladder; a mucosa extending step of expanding the balloon by operating an injection portion of an injection apparatus to inject a liquid into the balloon through a through hole of the shaft and extending a wall of a region to be treated; a light irradiation portion positioning step of positioning a light irradiation portion of a light irradiation probe in the balloon extending the wall; and a light irradiation step of irradiating light from the light irradiation portion to a mucosa of the wall through the balloon. Hereinafter, embodiments of the present invention will be described with reference to drawings. The reference sign 1 in The balloon catheter system 1 includes a light irradiation probe 10, a balloon catheter 20, and an injection apparatus 30. The light irradiation probe 10 includes a light irradiation portion 12 at a probe distal end portion 11 A probe proximal end portion 11 Specifically, the light is emitted from the irradiation portion peripheral surface 12 The balloon catheter 20 includes a shaft 21 and a balloon 22. The reference sign 23 denotes a port, and the port is provided at the end portion of the shaft 21. The shaft 21 is an elongated single-lumen tube having translucency. The shaft 21 includes one through hole 24 along a shaft axis a21. The shaft 21 is made of nylon, silicone, or Teflon (registered trademark). The inner diameter of the through hole 24 provided in the shaft 21 is set to be larger than the outer diameter of the fiber probe 11 by a predetermined dimension. Therefore, the fiber probe 11 is insertable into the through hole 24. The reference sign 24 The balloon 22 includes translucency and elasticity. The balloon 22 is a bag body having an opening on one side, and an opening side end portion 22 Therefore, the balloon 22 expands by a liquid being injected from the opening for balloon 24 A port 23 includes a shaft fixing hole 25, a probe port portion 26, and a liquid port portion 27. A shaft proximal end portion 21 The probe port portion 26 is provided on the proximal end portion side of the port 23. The liquid port portion 27 is provided so as to protrude from the side portion of the port 23. The probe port portion 26 includes a probe insertion hole 26 The fiber probe 11 is inserted into the probe insertion hole 26 Note that a retaining portion (not shown) is provided on the opening 26 The liquid port portion 27 includes a liquid hole 27 A liquid hole axis a27 of the liquid hole 27 Note that the liquid port axis a27 may diagonally intersects the shaft axis a21 and may be extended from the side portion in the proximal end direction. In addition, the syringe 32 may be directly attached to the liquid port portion 27. In this case, the liquid port portion 27 serves as a syringe attaching portion to and from which the syringe 32 is attachable and detachable. The syringe 32 is a cylindrical body having a liquid storage space 32S. The plunger 33 is arranged advanceably and retractably in the liquid storage space 32S so as to prevent the liquid from leaking outside from the liquid storage space 32S. The liquid stored in the liquid storage space 32S is passed through the inside of the liquid hole 27 The syringe 32 is provided with a plurality of scale marks and functions as a measuring portion. The syringe 32 is provided with scale marks s1, s2, and s3, for example. In the present embodiment, the first scale mark s1 notifies a user of a quantity of the liquid stored in advance in the syringe 32. The second scale mark s2 specifies the lower limit at the time when the liquid stored in the syringe 32 is injected into the balloon 22. The third scale mark s3 specifies the upper limit at the time when the liquid stored in the syringe 32 is injected into the balloon 22. The reference sign 40 denotes a contact detection portion, and the contact detection portion 40 detects that the outer surface of the balloon 22 comes into contact with the wall of a region to be treated. The contact detection portion 40 includes a tactile sensor 41 having a function for detecting the pressure, the reflection of light, the capacity change between the electrodes, and the like, and a signal line 42 extended from the tactile sensor 41. In the balloon catheter system 1 according to the present embodiment, when the tactile sensor 41 comes into contact with the wall of the region to be treated, a detection signal is outputted through the signal line 42, to cause a buzzer (not shown) to sound, for example. As a result, the operator is capable of judging that the wall 2 Note that the detection signal may be outputted wirelessly from the tactile sensor 41. The tactile sensor 41 is fixed to one portion which is a predetermined position on the outer surface of the balloon 22. The signal line 42 is extended from the tactile sensor 41 and arranged on the outer surfaces of the shaft 21 and the port 23, along the shaft axis a21 and the insertion hole axis a26. The signal line 42 is extended from the side portion on the proximal end side of the port 23, for example. In the present embodiment, the injection apparatus 30 is an injector including the syringe 32 and the plunger 33. However, the injection apparatus 30 may be a pump-type fluid supply apparatus (not shown), for example. In such a fluid supply apparatus, a pump (not shown) is driven by the operation of a pump driving switch (not shown) and the liquid is injected into the balloon 22 while the quantity of the liquid is being measured, to cause the balloon 22 to expand. Therefore, the pump is the injection portion. The measurement of the injection quantity of the liquid into the balloon 22 is performed by a flow rate sensor, which functions as a measuring portion, provided to the liquid feeding tube 31. Hereinafter, description will be made on the optical tumor treatment method using the balloon catheter system 1. The balloon catheter system 1 according to the present embodiment is used for treating the tumor of the bladder. Therefore, the balloon catheter 20 is disposable catheter for urinary organs, and the balloon 22 is a balloon for the bladder which is arranged in the bladder as a region to be treated. The volume of the fluid storage space 32S of the syringe 32 in the injection apparatus 30 corresponds to the volume of the bladder. That is, the second scale mark s2 of the syringe 32 is provided for notifying that the liquid stored in the syringe 32 up to the scale mark s1 is injected into the balloon 22 by 100 milliliters. The third scale mark s3 of the syringe 32 is provided for notifying that the liquid stored in the syringe 32 up to the scale mark s1 is injected into the balloon 22 by 300 milliliters. The quantity of 100 milliliters is a value supposed based on the average volume of the bladder recited in the above-described non-patent document 2. On the other hand, the quantity of 300 milliliters is a value determined under consideration of safety based on the recitation of the above-described non-patent document 1. That is, in the treatment of the tumor of the bladder, the injection quantity of the liquid into the balloon 22 is set to be 100 milliliters or more but 300 milliliters or less. Note that a medical staff member arranges the fiber probe 11 in advance in the through hole 24 of the shaft 21. In addition, the medical staff member connects, in advance, the syringe 32 in which normal saline is stored up to the first scale mark s1 and the liquid port portion 27 by the liquid feeding tube 31. The medical staff member administers, in advance, a medicinal agent that reacts to the light emitted from the light irradiation portion 12 to the patient via intravenous injection, before starting the optical treatment of the bladder by using the balloon catheter system 1. The treatment is started after a predetermined time period has elapsed. The treatment includes a balloon positioning step S201, a mucosa extending step S202, a light irradiation portion positioning step S203, and a light irradiation step S204, as shown in The mucosa extending step S202 includes a first expansion retaining step. In the first expansion retaining step, when the tactile sensor 41 provided on the outer surface of the balloon 22 detects that the outer surface of the balloon comes into contact with the wall 2 In the balloon positioning step S201, the operator positions the balloon 22, which is fixed to the one end portion of the shaft 21 of the balloon catheter 20, in the bladder 2, as shown in Note that the position of the proximal end side of the colored portion 14 is aligned with the position of the proximal end surface 26 In the mucosa extending step S202, the operator operates the injection portion 33 of the injection apparatus 30. In accordance with the movement of the injection portion 33, the normal saline in the liquid storage space 32S is injected into the balloon 22 through the through hole 24 of the shaft 21. Then, the inside of the balloon 22, the inside of the through hole 24, and the inside of the probe insertion hole 26 After that, the normal saline 3 is further injected into the balloon 22, to thereby cause the balloon 22 to start to expand. The operator confirms whether the residual quantity of the normal saline 3 in the liquid storage space 32S reaches the vicinity of the second scale mark s2 or reaches between the second scale mark s2 and the third scale mark s3, while performing the injection operation with the injection portion 33. The operator continues the injection of the normal saline 3, which causes a part of the outer surface of the balloon 22 (see the reference sign 22 As shown in In the light irradiation portion positioning step S203, the operator advances the light irradiation portion 12 of the fiber probe 11 in the through hole 24, while confirming the buzzer sound. This allows a part of 12 In the light irradiation step S204, the operator causes the light to irradiate from the light irradiation portion 12, while confirming the buzzer sound. That is, the operator operates a foot switch (not shown), for example, for a predetermined time period. Then, the light is emitted from the light emitter of the light source apparatus, and the light is passed through the fiber probe 11, emitted from the light irradiation portion 12, passed through the balloon 22, and irradiated to the mucosa of the wall 2 After the end of the light irradiation step, the operator causes the normal saline 3 to discharge from the inside of the balloon 22, to contract the balloon 22, and extracts the balloon catheter 20 to the outside of the body. Thus, according to the present embodiment, the bladder 2 can be expanded while gradually expanding the balloon 22 by injecting the liquid such as the normal saline 3 into the balloon 22. When the tactile sensor 41 provided on the outer surface of the balloon 22 comes into contact with the mucosa of the wall 2 In this expansion-retained state, the wall 2 In addition, the syringe 32 is provided with the scale marks s2 and s3 that respectively notify the lower limit and the upper limit of the normal saline 3 to be injected into the balloon 22. As a result, insufficient supply and excessive supply of the normal saline 3 into the balloon 22 can be prevented. Specifically, it is possible to surely prevent the state where the wall of the bladder becomes thin by the excessive supply of the normal saline and a tensile force is applied to the bladder. In addition, when the buzzer sounds before the residual quantity of the normal saline reaches the scale mark s2, it is possible to easily judge that a failure occurs in the balloon positioning step S201. In this case, the balloon positioning step is performed again to eliminate the failure. In the above-described embodiment, the tactile sensor 41 is fixed to one portion on the outer surface of the balloon 22. However, the number of the tactile sensor 41 is not limited to one, but tactile sensors may be provided at a plurality of portions. Specifically, as shown in Note that the positions where the tactile sensors 41 are provided are different depending on the expanded shape, the expanding start position and the like of the balloon 22, and three or more tactile sensors 41 may be provided. In addition, the operator may be notified that the wall 2 In the above-described embodiment, the contact detection portion 40 is the tactile sensor 41 provided on the outer surface of the balloon 22. However, the contact detection portion 40 is not limited to the tactile sensor 41, and may be an image pickup probe including an image sensor. In the present embodiment, a balloon catheter system 1A includes an image pickup probe 50, in addition to the light irradiation probe 10, as shown in The image pickup probe 50 includes an image pickup device 52 and a light-emitting element (not shown) at an insertion portion distal end portion 51 When performing an optical treatment of the bladder by using the balloon catheter system 1A, the medical staff member arranges the insertion portion 51, instead of the fiber probe 11, in the through hole 24 of the shaft 21. The outer diameter of the insertion portion 51 is set to be equal to or slightly smaller than the outer diameter of the fiber probe 11. In addition, the mucosa extending step S202 includes a second expansion retaining step, instead of the first expansion retaining step. In the second expansion retaining step, the operator observes the image through the balloon 22, which is displayed on the screen of the display apparatus, to confirm that the balloon 22 is in contact with the wall 2 Note that the tumor region to be treated is the bladder. The medical staff member connects the syringe 32 and the liquid port portion 27 with the liquid feeding tube 31. In addition, the medical staff member administers a medicinal agent that reacts to the light emitted from the light irradiation portion 12 to the patient via intravenous injection. Furthermore, the retaining portion on the opening 26 In the balloon positioning step S201, the operator positions the balloon 22 fixed to the one end portion of the shaft 21 of the balloon catheter 20 in the bladder 2, as shown in After that, in the mucosa extending step S202, the operator injects the normal saline 3 stored in the liquid storage space 32S into the balloon 22 in the similar manner as described above. As described above, the balloon 22, the through hole 24, and the probe insertion hole 26 The operator continues the injection operation while performing injection operation by the injection portion 33, observing the image displayed on the screen of the display apparatus, and confirming the residual quantity in the liquid storage space 32S. Then, as shown in The operator observes a change in the contact area between the balloon 22 and the wall 2 After that, the procedure shifts to the light irradiation portion positioning step S203. After extracting the insertion portion 51 from the through hole 24 of the shaft 21, the operator inserts the fiber probe 11 of the light irradiation probe 10 into the through hole 24, to arrange the light irradiation portion 12 in the balloon 22 which is expanded while in contact with the wall 2 After the end of the light irradiation step, the operator causes the normal saline 3 to discharge from the inside of the balloon 22 to contract the balloon 22, and extracts the balloon catheter 20 to the outside of the body. Thus, the balloon catheter system 1A according to the present embodiment includes the image pickup probe 50, in addition to the light irradiation probe 10. When confirming the image of the mucosa of the wall 2 Note that, according to the above-described balloon catheter system 1A, when the procedure shifts to the light irradiation portion positioning step S203, the operation of extracting the insertion portion 51 from the through hole 24 of the shaft 21 and the operation of inserting the fiber probe 11 into the through hole 24 are performed. Such operations are required, since the shaft 21 is a single-lumen tube. In view of the above, the shaft 21 is configured as a double-lumen tube including an insertion portion hole (not shown) as a first tube through hole through which the insertion portion 51 is insertable, and a fiber probe hole (not shown) as a second tube through hole through which the fiber probe 11 is insertable. Such a configuration enables the procedure to smoothly shift to the light irradiation portion positioning step S203 and then shift to the light irradiation step S204, with the insertion portion 51 arranged in the insertion portion hole, without the need for extracting the insertion portion 51 from the insertion portion hole. In addition, according to the configuration, the operator is capable of reconfirming the image captured by the image pickup device 52 of the image pickup probe 50 in the light irradiation portion positioning step S203, and thereafter shifting the procedure to the light irradiation step S204. In the above-described embodiment, the contact detection portion 40 is the image pickup probe 50 including the image pickup device 52. However, the contact detection portion may be an image pickup device 52A of an endoscope 60 including a treatment instrument channel through which the shaft 21 of the balloon catheter 20 is inserted. The endoscope system shown in In the present embodiment, the distal end surface of the endoscope distal end portion 63 of the endoscope insertion portion 62 is arranged in the vicinity of the bladder. Then, in the balloon positioning step S201, the operator positions the balloon 22, which is fixed to the shaft 21 of the balloon catheter 20 inserted through the treatment instrument channel 71, in the bladder 2, while observing the image of the balloon 22, as shown in After that, the operator injects the normal saline 3 into the liquid storage space 32S in the mucosa extending step S202, similarly as described above. After the inside of the balloon 22, the inside of the through hole 24, and the inside of the probe insertion hole 26 The operator continues the injection operation while performing injection operation by the injection portion 33, observing the image displayed on the screen of the display apparatus, and confirming the residual quantity in the liquid storage space 32S. Then, a part (see the reference sign 22 The operator observes the change in the contact area between the balloon 22 and the wall 2 After that, the procedure shifts to the light irradiation portion positioning step S203. At this time, the operator arranges the light irradiation portion 12 in the balloon 22, which is expanded while in close contact with the wall 2 After the end of the light irradiation step, the operator extracts the endoscope insertion portion 62 to the outside of the body. Thus, in the present embodiment, the operator inserts the shaft 21 of the balloon catheter 20 of the balloon catheter system 1 into the treatment instrument channel 71 of the endoscope 60, to position the shaft 21 in the bladder. After that, the operator confirms, through the balloon 22 or directly, the contacting state between the outer surface of the balloon 22 and the wall 2 Upon confirming the closely contacting state between the balloon 22 and the wall 2 The present invention is not limited to the above-described embodiments, and various changes, modifications, and the like are possible in a range without changing the gist of the present invention. A balloon catheter system includes: a light irradiation probe including, at a distal end portion of a fiber probe, a light irradiation portion for irradiating light; a balloon catheter including a shaft having a through hole through which the light irradiation probe is insertable, the through hole allowing liquid feeding, with the light irradiation probe being arranged, and a balloon provided to the shaft and configured to be expandable and contractable by a liquid injected into the balloon; and an injection apparatus including a measuring portion capable of measuring a quantity of the liquid, and an injection portion for injecting the liquid measured by the measuring portion into the balloon, and the balloon expands by the injected liquid, to thereby extend a wall of a region to be treated and retain the wall of the region to be treated in an extended state. 1. A balloon catheter system comprising:
a light irradiation probe including, at a distal end portion of a fiber probe, a light irradiation portion configured to irradiate light; a balloon catheter including a shaft and a balloon, the shaft including a through hole in which the light irradiation probe is arrangeable, the through hole being configured to allow liquid feeding, with the light irradiation probe being arranged in the through hole, the balloon being fixed to one end portion of the shaft and configured to be expandable and contractable by a liquid injected through the through hole of the shaft; and an injection apparatus including a measuring portion configured to be capable of measuring a quantity of the liquid to be injected into the balloon, and an injection portion configured to inject the liquid measured by the measuring portion into the balloon through the through hole, wherein the balloon expands by the liquid injected into the balloon, to thereby extend a wall of a region to be treated, and the expanded balloon retains the wall of the region to be treated in an extended state. 2. The balloon catheter system according to 3. The balloon catheter system according to 4. The balloon catheter system according to 5. The balloon catheter system according to 6. The balloon catheter system according to 7. The balloon catheter system according to 8. The balloon catheter system according to 9. The balloon catheter system according to 10. An optical tumor treatment method comprising:
a balloon positioning step of arranging a balloon fixed to one end portion of a shaft of a balloon catheter in a region to be treated; a mucosa extending step of expanding the balloon by operating an injection portion of an injection apparatus to inject a liquid into the balloon through a through hole of the shaft and extending a wall of the region to be treated; a light irradiation portion positioning step of arranging a light irradiation portion of a light irradiation probe in the balloon extending the wall, and a light irradiation step of irradiating light from the light irradiation portion to a mucosa of the wall through the balloon. 11. The optical tumor treatment method according to 12. The optical tumor treatment method according to 13. The optical tumor treatment method according to 14. The optical tumor treatment method according to 15. The optical tumor treatment method according to BACKGROUND OF THE INVENTION
1. Field of the Invention
2. Description of Related Art
SUMMARY OF THE INVENTION
BRIEF DESCRIPTION OF THE DRAWINGS
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS







