Prostate treatment method, treatment instrument, and bladder tumor treatment method

Abstract

This prostate treatment method includes an insertion step of inserting a balloon coated with a medicine into a urethra, an expansion step of expanding the balloon in a prostate part where the prostate is located in the urethra, and a step of injecting the medicine by piercing the prostate part with a microneedle attached to the surface of the balloon. This bladder tumor treatment method is for treating a bladder tumor having a tumor bulging part and a tumor bottom part, the bladder tumor treatment method being provided with a cutting step of cutting off the tumor bulging part, and a freezing step of freezing the tumor bottom part.

Description

Prostate treatment method, treatment device, and bladder tumor treatment method

[0001] The present disclosure relates to a prostate treatment method, a treatment device, and a bladder tumor treatment method.

[0002] Conventionally, transurethral treatment has been performed using a cystoscope for observing the inside of the bladder. Patent Documents 1 and 2 describe methods for treating benign prostatic hyperplasia. Patent Document 3 describes transurethral resection of bladder tumor (TURBT).

[0003] US Patent No. 11904072 US Patent No. 11484628 Japanese Patent Application Laid-Open No. 2010-521488

[0004] However, transurethral treatment is desirable as it is less invasive.

[0005] In light of the above circumstances, an object of the present disclosure is to provide a prostate treatment method, a treatment device, and a bladder tumor treatment method that enable less invasive transurethral treatment.

[0006] In order to solve the above problems, the present invention proposes the following means: A prostate treatment method according to a first aspect of the present disclosure includes an insertion step of inserting a drug-coated balloon into the urethra, an expansion step of expanding the balloon at a prostatic region where the prostate is located in the urethra, and a step of piercing microneedles attached to the surface of the balloon into the prostatic region to inject the drug.

[0007] A treatment instrument according to a second aspect of the present disclosure comprises a sheath having an elongated shape extending along an axial direction and having a lumen through which a fluid is supplied, and a balloon provided at the tip of the sheath and communicating with the lumen and capable of expanding, the surface of the balloon being coated with a drug and having a plurality of microneedles provided on the surface of the balloon.

[0008] A bladder tumor treatment method according to a third aspect of the present disclosure is a method for treating a bladder tumor having a tumor protuberance and a tumor base, comprising a cutting step for excising the tumor protuberance and a freezing step for freezing the tumor base.

[0009] The prostate treatment method, treatment device, and bladder tumor treatment method disclosed herein enable less invasive transurethral treatment.

[0010] FIG. 1 is a diagram showing the overall configuration of a cystoscope system according to a first embodiment of the present disclosure. FIG. 2 is a diagram showing the overall configuration of a treatment tool of the cystoscope system. FIG. 3 is a diagram showing the overall configuration of a verumontanum protection device of the cystoscope system. FIG. 4 is a diagram showing a protection portion of the verumontanum protection device. FIG. 5 is a diagram showing a first dilation step. FIG. 6 is a diagram showing a protection step. FIG. 7 is a diagram showing a second dilation step. FIG. 8 is a diagram showing a removal step. FIG. 9 is a diagram showing a tip portion of an endoscopic device according to a second embodiment. FIG. 10 is a diagram showing the suction and ablation step. FIG. 11 is a diagram showing the suction and ablation step. FIG. 12 is a diagram showing a freezing step. FIG. 13 is a diagram showing a confirmation step. FIG. 14 is a diagram showing a thawing step.

[0011] First Embodiment A first embodiment of the present disclosure will be described with reference to FIGS. 1 to 8. FIG.

[0012] 1 is a diagram showing the overall configuration of a cystoscope system 300 according to this embodiment. The cystoscope system 300 includes a cystoscope 200 inserted into a urethra U, a treatment instrument 100 inserted into a treatment instrument channel 201 of the cystoscope 200, and a verumontanum protection device 150.

[0013] The cystoscope 200 is appropriately selected from known flexible ureteroscopes, and is equipped with a long insertion section 202 having a treatment tool channel 201 through which a treatment tool can be inserted. The cystoscope 200 has an operating section 204 at its base end. The operating section 204 is provided with a treatment tool insertion hole 205, and the treatment tool 100 and the verumontanum protection device 150 are inserted into the treatment tool channel 201 through the treatment tool insertion hole 205. The outer diameter of the insertion section 202 of the cystoscope 200 is, for example, 6.5 mm to 7.5 mm.

[0014] The cystoscope 200 has an illumination unit and an imaging unit (observation unit) at the tip of the insertion section 202. The tip of the treatment instrument 100 or the like inserted into the treatment instrument channel 201 protrudes from a channel opening 203 at the tip of the insertion section 202.

[0015] Cystoscope 200 is connected to endoscope system 210. Endoscope system 210 includes a light source that provides light to an illumination unit of cystoscope 200. Endoscope system 210 also includes an image processing circuit and the like that processes images captured by the imaging unit of cystoscope 200 and displays the images on a monitor.

[0016] 2 is a diagram showing the overall configuration of the treatment instrument 100. The treatment instrument 100 is a balloon catheter for treating prostatic hyperplasia. It includes a sheath 1, a distal balloon 2, a drug-coated balloon 3, and an operating unit 5. In the following description, the operating unit 5 side of the treatment instrument 100 is referred to as the base end side (proximal side), and the side opposite the operating unit 5 in the axial direction (longitudinal direction) A of the sheath 1 is referred to as the distal side (distal side). The direction perpendicular to the axial direction A is referred to as the radial direction R.

[0017] The sheath 1 is formed in an elongated shape extending along the axial direction A. The sheath 1 can be inserted into and removed from a treatment instrument channel 201 of the cystoscope 200. A lumen 12 is formed over the entire length of the sheath 1. The lumen 12 is a path for supplying fluid to the distal balloon 2 and the drug-coated balloon 3.

[0018] The distal balloon 2 is provided on the outer peripheral surface of the distal end of the sheath 1. The distal balloon 2 is provided over the entire circumferential direction of the sheath 1 in the axial direction A. The distal balloon 2 is connected to the lumen 12, and fluid is supplied from the lumen 12. The distal balloon 2 can be expanded by the supplied fluid.

[0019] The drug-coated balloon 3 is a balloon whose surface is coated with a drug. The drug-coated balloon 3 is provided on the outer peripheral surface of the distal end of the sheath 1. The drug-coated balloon 3 is provided adjacent to the distal balloon 2 on the proximal end side of the distal balloon 2. The drug-coated balloon 3 is provided around the entire circumferential direction of the sheath 1 in the axial direction A. The drug-coated balloon 3 is in communication with the distal balloon 2, and fluid is supplied from the distal balloon 2.

[0020] The expanded drug-coated balloon 3 has an elongated spheroidal shape extending in the axial direction A. The maximum outer diameter in the radial direction R of the drug-coated balloon 3 expanded by supplying fluid is, for example, 6.0 mm to 8.0 mm, and preferably 7.0 mm to 7.5 mm. Furthermore, the maximum outer diameter in the radial direction R of the drug-coated balloon 3 expanded by supplying fluid is approximately the same as the outer diameter of the insertion portion 202 of the cystoscope 200, for example.

[0021] A plurality of microneedles 31 are provided on the surface of the drug-coated balloon 3. The microneedles 31 have sharp tips and are inserted into the prostate gland UP. The outer diameter of the microneedles 31 is, for example, 0.1 mm to 0.15 mm. The length of the microneedles 31 is, for example, 2.0 mm to 2.5 mm. The microneedles 31 are inserted into the surface of the drug-coated balloon 3 by approximately 0.2 mm. ２ ~0.3 mm ２ One line is provided for each area.

[0022] The surface of the drug-coated balloon 3, including the tip of the microneedle, is coated with a drug. The coated drug may be ethanol, botulinum toxin, an antiandrogen, bromelain, an FGFR inhibitor, or a combination thereof. Ethanol has the effect of shrinking the prostate. Botulinum toxin has the effect of alleviating the symptoms of benign prostatic hyperplasia.

[0023] The cystoscope system 300 may include variations of the treatment tool 100 that differ in the length of the drug-coated balloon 3 in the axial direction A. The surgeon can select the variation of the treatment tool 100 that is most suitable for the patient.

[0024] The operation unit 5 has a supply port 51 to which a syringe or the like is connected to supply fluid to the lumen 12 .

[0025] 3 is a diagram showing the overall configuration of the collus verumontanum protection device 150. The collus verumontanum protection device 150 is a device that protects the collus verumontanum V. The collus verumontanum protection device 150 has a sheath 6, a protection portion 7, and a handle 8.

[0026] The sheath 6 is an elongated member extending along the axial direction A. The sheath 6 is insertable into and retractable from a treatment instrument channel 201 of the cystoscope 200. A protective portion 7 is provided at the tip of the sheath 6. A handle 8 is provided at the base end of the sheath 6.

[0027] 4 is a diagram showing the protective part 7. The protective part 7 has a loop wire 71 and a protective sheet 72. The loop wire 71 memorizes a loop shape and expands into a loop shape when protruding from the channel opening 203. The protective sheet 72 is attached to the loop wire 71. The protective sheet 72 covers at least a portion of the loop-shaped space formed by the loop wire 71.

[0028] Next, a procedure using the cystoscope system 300 of this embodiment (a method of using the cystoscope system 300) will be described. Specifically, the treatment of the enlarged prostate gland P will be described. In the following description, the portion of the urethra U where the prostate gland P is located will be referred to as the "prostate region UP."

[0029] <Selection Step> Before treating the prostate P, the surgeon may select the treatment tool 100 that is optimal for the treatment. Specifically, the surgeon measures the length of the prostate UP in the direction along the patient's urethra U using an ultrasound probe or the like. The surgeon determines the length of the axial direction A of the drug-coated balloon 3 based on the length of the prostate UP. It is desirable that the length of the axial direction A of the drug-coated balloon 3 be, for example, approximately the same as the length of the prostate UP or slightly shorter than the length of the prostate UP. The surgeon can select a variation of the treatment tool 100 that is optimal for the length of the prostate UP of the patient.

[0030] <Insertion Step> The surgeon inserts the insertion section 202 of the cystoscope 200 into the urethra U and inserts the tip of the insertion section 202 into the inside of the bladder B. While checking the image captured by the imaging section displayed on the monitor, the surgeon adjusts the position of the tip of the insertion section 202. Next, the surgeon inserts the treatment tool 100 through the treatment tool channel 201 and protrudes the tip balloon 2 from the channel opening 203.

[0031] 5 is a diagram showing the first dilation step. The surgeon supplies fluid to the lumen 12 to dilate the distal balloon 2. The surgeon hooks the dilated distal balloon 2 onto the bladder neck BN of the bladder B.

[0032] <Placement step> After the surgeon hooks the expanded distal balloon 2 onto the bladder neck BN, it is desirable for the surgeon to position the drug-coated balloon 3 in the prostate region UP, for example, by pulling the drug-coated balloon 3 toward the base end or pushing it toward the distal end.

[0033] <Protection Step> Figure 6 is a diagram showing the protection step. The surgeon inserts the collus verumontanum protection device 150 through the treatment instrument channel 201, causing the protection portion 7 to protrude from the channel opening 203. The surgeon moves the collus verumontanum protection device 150 so that the protection sheet 72 of the protection portion 7 is positioned to protect the collus verumontanum V. Note that the surgeon may leave the collus verumontanum protection device 150 inserted through the treatment instrument channel 201 when inserting the treatment instrument 100.

[0034] <Second Expansion Step> Figure 7 is a diagram showing the second expansion step. The surgeon further supplies fluid to the lumen 12 to expand the drug-coated balloon 3. The microneedles 31 attached to the surface of the drug-coated balloon 3 pierce the prostate region UP, and the drug D is injected into the prostate region UP. Because the tips of the microneedles are formed sharp, the drug D penetrates the prostate region UP efficiently. Because the microneedles are provided over the entire surface of the drug-coated balloon 3, the drug D penetrates the entire prostate region UP.

[0035] The drug-coated balloon 3 expands in the radial direction R, thereby expanding radially relative to the urethra U. The maximum outer diameter of the expanded drug-coated balloon 3 in the radial direction R is, for example, 6.0 mm to 8.0 mm, which is smaller than the maximum outer diameter (e.g., 30 mm) of balloons used in conventional prostate treatments. Therefore, the drug-coated balloon 3 expands until it appropriately contacts the entire prostate gland UP, but does not expand beyond that size. This reduces the risk of damage to the urethra U or retrograde ejaculation due to excessive expansion of the drug-coated balloon 3.

[0036] The verumontanum V is protected by the protective sheet 72 of the protective part 7, and is protected from the drug coated on the surface of the drug-coated balloon 3. Therefore, the risk of transient anejaculation due to the drug penetrating into the verumontanum V can be reduced.

[0037] In this procedure, the surgeon inserts the drug-coated balloon 3 into the prostatic portion UP of the urethra U without dilating the prostatic portion UP of the urethra U with a pre-dilation balloon (PDB), which is used in conventional prostate treatments. Since a dilation balloon is not required, the procedure is simplified and the risk of damage to the bladder neck BN and the urethra U can be reduced.

[0038] 8 is a diagram showing the removal step. After the drug has sufficiently penetrated the prostate gland UP, the surgeon removes the insertion portion 202 of the cystoscope 200 from the urethra U.

[0039] In this procedure, the microneedles allow the drug to efficiently penetrate the prostate gland UP, eliminating the need for the surgeon to place a Foley catheter, which is used in conventional prostate treatments, in the urethra U. However, if necessary, the surgeon may insert a Foley catheter into the urethra U for a certain period of time to maintain the drug that has penetrated the prostate gland UP.

[0040] The cystoscope system 300 of this embodiment enables less invasive transurethral treatment (treatment of an enlarged prostate gland P). Specifically, the risk of damage to the urethra U and retrograde ejaculation due to excessive expansion of the drug-coated balloon 3 can be reduced. The risk of transient anejaculation due to drug penetration into the verumontanum V can be reduced. As an expansion balloon is not required, the treatment procedure is simplified and the risk of damage to the bladder neck BN and urethra U can be reduced. There is no need to place a Foley catheter in the urethra U.

[0041] Although the first embodiment of the present disclosure has been described above in detail with reference to the drawings, the specific configuration is not limited to this embodiment and includes design modifications within the scope of the present disclosure. Furthermore, the components shown in the above-described embodiment and modified examples can be configured by appropriately combining them.

[0042] Second Embodiment A second embodiment of the present disclosure will be described with reference to Fig. 9 to Fig. 16. In the following description, configurations that are common to those already described will be assigned the same reference numerals, and duplicated description will be omitted.

[0043] A treatment system 600 according to the second embodiment (see FIG. 14 ) includes an endoscopic device 400 and a cryotherapy device 500 .

[0044] 9 is a diagram showing the distal end of an endoscopic device 400 according to the second embodiment. The endoscopic device 400 is a catheter equipped with a camera. The endoscopic device 400 includes a long insertion section 402 having a treatment tool channel 401 through which a treatment tool can be inserted. The insertion section 402 is insertable into the urethra U. The endoscopic device 400 has an operation section at its proximal end. The operation section is provided with a treatment tool insertion hole, and a treatment tool such as a cryotherapy device 500 is inserted into the treatment tool channel 401 through the treatment tool insertion hole.

[0045] The endoscopic device 400 has a protrusion 405, an illumination unit 406, and an imaging unit (observation unit) 407 at the tip of the insertion unit 402. The protrusion 405 protrudes toward the tip side from the portion where the illumination unit 406 and the imaging unit 407 are provided. A channel opening 403 at the tip of the insertion unit 402 is provided at the tip of the protrusion 405. The tip of a cryotherapy device 500 or the like inserted into the treatment instrument channel 401 protrudes from the channel opening 403 at the tip of the insertion unit 402.

[0046] The treatment instrument channel 401 is connected to a pump, and suction and air / water supply can be performed from a channel opening 403 via the treatment instrument channel 401 .

[0047] An active electrode 410 is provided at the channel opening 403 of the treatment instrument channel 401. The active electrode 410 is formed along the circumferential direction of the channel opening 403.

[0048] The endoscopic device 400 is connected to the endoscopic system 210. The endoscopic system 210 includes a light source that provides light to the illumination unit 406 of the endoscopic device 400. The endoscopic system 210 also includes an image processing circuit and the like that processes an image captured by the imaging unit 407 of the endoscopic device 400 and displays the image on a monitor.

[0049] The cryo-treatment device 500 is appropriately selected from known local cryo-treatment devices and has a tip portion 510 (see FIG. 14) that performs local freezing.

[0050] Next, a procedure using the treatment system 600 of this embodiment (a method of using the treatment system 600) will be described. Specifically, a procedure for transurethrally resecting a bladder tumor C will be described. The bladder tumor C illustrated in FIG. 1 is a pedunculated bladder tumor, and is divided into a tumor protuberance C1 and a tumor base C2. This procedure can also be used for sessile bladder tumors.

[0051] In the past, a procedure was sometimes performed in which the tumor protuberance C1 was excised and collected using biopsy forceps inserted through an endoscope channel, and the tumor base C2 was cauterized using radio frequency or laser. However, this was only effective for very small bladder tumors C, such as those measuring 5 mm or less. The reasons for this include, for example, that the area that can be excised using forceps is small, which requires repeated excision and collection, making the procedure time-consuming and painful for the patient; and, in the case of large bladder tumors C, the tumor may have penetrated deeply, which poses a risk of perforation if cauterized deeply using radio frequency or laser.

[0052] <Insertion Step> The surgeon replaces the inside of the bladder B with physiological saline. Next, the surgeon inserts the insertion section 402 of the endoscopic device 400 into the urethra U and inserts the tip of the insertion section 402 into the inside of the bladder B. The surgeon brings the tip of the insertion section 402 close to the bladder tumor C while checking the image captured by the imaging section 407 displayed on the monitor.

[0053] <Suction Resection Step> Figures 10 to 12 are diagrams illustrating the suction resection step. With high-frequency current applied to the active electrode 410, the surgeon aspirates the tumor protuberance C1 through the channel opening (suction conduit) 403. The endoscopic device 400 uses the active electrode 410 to cut the tumor protuberance C1 into small pieces while simultaneously aspirating the tumor protuberance C1 through the channel opening 403. The surgeon resects only the tumor protuberance C1, leaving the tumor base C2. Treatment of the tumor protuberance C1 by suction resection allows for aspirating the tumor protuberance C1 while resecting it, thereby shortening the time required to resect and collect the tumor protuberance C1, reducing the burden on the patient, and also reducing the risk of dissemination.

[0054] <Freezing Step> Figures 13 and 14 are diagrams illustrating the freezing step. As shown in Figure 1, the surgeon inserts the cryotherapy device 500 into the treatment instrument channel 201 and projects the tip 510 from the channel opening 203. As shown in Figure 14, the surgeon places the tip 510 against the tumor base C2. The surgeon supplies cryogas to the tip 510 via the cryotherapy device insertion section 520, filling the balloon of the tip 510 with cryogas or releasing the cryogas from the tip 510. The tip 510 adheres to the tumor base C2, freezing the tumor base C2 (cryoablation). Freezing kills tumor cells in the tumor base C2. Treatment of the tumor base C2 by freezing is safer, with a lower risk of perforating the bladder wall, compared to treatments using high frequency or laser.

[0055] <Confirmation Step> Figure 15 shows the confirmation step. The surgeon can adjust and confirm the freezing range in the depth direction by controlling the time for which cryogas is supplied to the tip portion 510. Alternatively, the surgeon may measure the depth of the frozen tumor base C2 using an ultrasound device 700 or the like. This allows the surgeon to confirm that freezing has been achieved down to the deep layers into which the tumor has progressed.

[0056] 16 is a diagram showing the melting step. The surgeon flows fluid W between the tip 510 of the cryotherapy device 500 and the tumor base C2 by supplying water from the channel opening 403 via the treatment instrument channel 401, and then peels the tip 510 away from the tumor base C2. The surgeon waits for the frozen tumor base C2 to melt.

[0057] The operator repeats the freezing and thawing steps as necessary.

[0058] <Removal Step> The surgeon removes the insertion portion 402 of the endoscopic device 400 from the urethra U.

[0059] The treatment system 600 of this embodiment enables minimally invasive transurethral treatment (bladder tumor resection). The suction resection step not only shortens surgical time and reduces patient burden, but also suppresses tumor dissemination. The confirmation step confirms that tumors have been frozen to the deep layers where they have spread. The freezing step kills tumor cells but preserves their proteins, preserving the extracellular matrix and reducing the risk of bladder wall perforation. The preserved tumor cell-derived proteins are expected to induce immune responses. These effects reduce pain and shorten the procedure time, making the procedure safe and enabling the procedure to be performed under local anesthesia. Furthermore, when using known cryodevices for large tumors without resecting the tumor protuberance C1, problems arise, such as the long time required to freeze the tumor down to the tumor base C2, the patient being unable to tolerate the pain of endoscope insertion and therefore unable to perform the procedure under local anesthesia, or insufficient freezing resulting in ineffective tumor eradication. However, the treatment system 600 of this embodiment solves these problems.

[0060] Although the second embodiment of the present disclosure has been described above in detail with reference to the drawings, the specific configuration is not limited to this embodiment and includes design modifications within the scope of the present disclosure. Furthermore, the components shown in the above embodiment and modified examples can be configured by appropriately combining them.

[0061] The surgeon may resect the tumor protrusion C1 using a treatment tool such as a snare (cutting step). A snare can resect larger tumors than conventional forceps, thereby shortening the procedure time. In this case, the surgeon separately performs a retrieval step to retrieve the resected tumor protrusion C1. The surgeon may perform the retrieval step using, for example, a snare, a basket, grasping forceps, or a treatment tool capable of holding the resected tumor protrusion C1 using suction. The surgeon may retrieve the resected tumor protrusion C1 using the treatment tool through the treatment tool channel 401 of the endoscopic device 400, or may remove the endoscopic device 400 from the body cavity. When removing the endoscopic device 400 from the body cavity, a sheath may be placed inside the patient's urethra outside the endoscopic device 400, and the endoscopic device 400 may be removed relative to the sheath. This prevents the resected tumor protrusion C1 from touching the patient's urethra, thereby reducing the risk of dissemination. The surgeon may perform the retrieval step at any time after resecting the tumor protrusion C1.

[0062] Instead of the freezing, confirmation, and thawing steps, the surgeon may perform a "tumor bottom (lower part) C2 treatment step" using a procedure that destroys tumor cells while preserving the extracellular matrix, such as cold plasma or photoimmunotherapy. These treatments also kill tumor cells but preserve proteins, which not only preserves the extracellular matrix and reduces the risk of bladder wall perforation, but can also be expected to induce immune responses via the preserved tumor cell-derived proteins. In this case, the surgeon may also perform a confirmation step.

[0063] (Supplementary Item 1) A method for treating bladder tumors, comprising the steps of: resecting the tumor protuberance (upper part); and performing a treatment at the tumor base (lower part) to destroy tumor cells while preserving the extracellular matrix. (Supplementary Item 2) A method for treating bladder tumors according to Supplementary Item 1, wherein the step of resecting the tumor protuberance (upper part) includes simultaneously collecting the resected piece. (Supplementary Item 3) A method for treating bladder tumors according to Supplementary Item 1, comprising the step of collecting the resected piece after the step of resecting the tumor protuberance (upper part). (Supplementary Item 4) A method for treating bladder tumors according to Supplementary Item 1, comprising the step of collecting the resected piece after the step of performing a treatment at the tumor base (lower part) to destroy tumor cells while preserving the extracellular matrix. (Supplementary Item 5) A method for treating bladder tumors according to Supplementary Item 1, wherein the step of resecting the tumor protuberance (upper part) includes resecting the tumor in one piece, even if the tumor is larger than 10 mm. (Supplementary Item 6) The method for treating bladder tumors according to Supplementary Item 1, wherein the step of resecting the tumor protuberance (upper part) comprises using a snare to perform the resection. (Supplementary Item 7) The method for treating bladder tumors according to Supplementary Item 1, wherein the step of resecting the tumor protuberance (upper part) comprises using a morcellator to perform the resection. (Supplementary Item 8) The method for treating bladder tumors according to Supplementary Item 1, wherein the step of resecting the tumor protuberance (upper part) comprises using a suction-type morcellator to perform the resection. (Supplementary Item 9) The method for treating bladder tumors according to Supplementary Item 1, wherein the step of resecting the tumor protuberance (upper part) comprises using a morcellator that performs resection with high frequency. (Supplementary Item 10) The method for treating bladder tumors according to Supplementary Item 1, wherein the step of performing a treatment to destroy tumor cells while preserving the extracellular matrix at the tumor base (lower part) comprises performing the treatment using cryoablation. (Supplementary Item 11) The method for treating a bladder tumor according to Supplementary Item 1, wherein the step of destroying tumor cells while preserving the extracellular matrix at the base (lower part) of the tumor comprises performing the treatment using cold plasma. (Supplementary Item 12) The method for treating a bladder tumor according to any one of Supplementary Item 2 to Supplementary Item 4, wherein the step of recovering comprises grabbing and recovering the tumor cells with a snare.(Supplementary Item 13) The method for treating bladder tumors according to any one of Supplementary Items 2 to 4, wherein the retrieval comprises grasping the resection piece with a basket. (Supplementary Item 14) The method for treating bladder tumors according to any one of Supplementary Items 2 to 4, wherein the retrieval comprises grasping the resection piece with forceps. (Supplementary Item 15) The method for treating bladder tumors according to any one of Supplementary Items 2 to 4, wherein the retrieval comprises using a suction-capable treatment tool to hold the resection piece by suction. (Supplementary Item 16) The method for treating bladder tumors according to any one of Supplementary Items 12 to 15, wherein the retrieval comprises inserting the treatment tool used for the retrieval through a channel of an endoscopic device and retrieving the resection piece by passing it through the channel. (Supplementary Item 17) The bladder tumor treatment method according to any one of Supplementary Items 12 to 15, wherein the retrieval comprises inserting a treatment tool used for the retrieval through a channel of an endoscopic device and withdrawing and retrieving the endoscopic device together from the body. (Supplementary Item 18) The bladder tumor treatment method according to Supplementary Item 17, wherein when withdrawing and retrieving the resection piece together with the endoscopic device from the body, the method comprises withdrawing the endoscopic device and the resection piece relative to a sheath placed outside the endoscopic device. (Supplementary Item 19) A treatment device comprising: a tumor resection unit that resects a tumor protuberance (upper part) from a bladder tumor having a tumor protuberance (upper part) and a tumor base (lower part) and leaves the tumor base (lower part); and a tumor retrieval unit that retrieves the tumor protuberance (upper part). (Supplementary Item 20) The treatment device according to Supplementary Item 19, wherein the tumor resection unit is an active electrode through which a high-frequency current is passed. (Supplementary Item 21) The treatment device according to Supplementary Item 19, wherein the tumor resection unit is a wire snare. (Supplementary Item 22) The treatment device according to Supplementary Item 19, wherein the tumor collection unit is a suction conduit. (Supplementary Item 23) The treatment device according to Supplementary Item 22, wherein the suction conduit is a channel opening. (Supplementary Item 24) The treatment device according to Supplementary Item 19, wherein an operation time of the tumor resection unit and an operation time of the tumor collection unit at least partially overlap. (Supplementary Item 25) The treatment device according to Supplementary Item 24, wherein an operation of the tumor resection unit and an operation of the tumor collection unit are simultaneous.

[0064] The present disclosure is applicable to transurethral treatments.

[0065] DESCRIPTION OF SYMBOLS 300 Cystoscope system 200 Cystoscope 201 Treatment tool channel 202 Insertion section 203 Channel opening 204 Operation section 205 Treatment tool insertion hole 210 Endoscope system 100 Treatment tool 1 Sheath 12 Lumen 2 Tip balloon 3 Drug-coated balloon 31 Microneedle 5 Operation section 150 Verumontanum protection device 6 Sheath 7 Protective section 71 Loop wire 72 Protective sheet 8 Handle 600 Treatment system 400 Endoscope device 401 Treatment tool channel 402 Insertion section 403 Channel opening 405 Protrusion 406 Illumination section 407 Imaging section (observation section) 410 Active electrode 500 Cryotherapy device 510 Tip section 520 Insertion section 700 Ultrasound device A Axial direction (longitudinal axis direction) R Radial direction B Bladder BN Bladder neck D Drug P Prostate U Urethra UP Prostatic region V Verumontanum C Bladder tumor C1 Tumor protuberance C2 Tumor base W Fluid

Claims

1. A method for treating prostate gland, comprising: an insertion step of inserting a drug-coated balloon into a urethra; an expansion step of expanding the balloon at a prostatic region where the prostate gland is located in the urethra; and a step of piercing microneedles attached to the surface of the balloon into the prostatic region to inject the drug.

2. The method for treating prostate gland according to claim 1, further comprising, prior to the inserting step, a step of measuring the length of the prostate gland in a direction along the urethra and determining the axial length of the balloon based on the length of the prostate gland.

3. The method for treating prostate gland according to claim 1, wherein in the inserting step, the balloon is inserted into the urethra that has not been dilated by another medical device.

4. The method for treating prostate gland according to claim 1, wherein in the expanding step, the balloon is expanded until it contacts the entire prostate portion of the urethra.

5. The method for treating prostate gland according to claim 1, wherein in the expanding step, the maximum outer diameter of the balloon expanded in the radial direction of the urethra is 6.0 mm to 8.0 mm.

6. A method for treating prostate gland according to claim 1, wherein in the insertion step, the balloon is inserted using a cystoscope, and in the expansion step, the maximum outer diameter of the balloon expanded radially of the urethra is approximately the same as the outer diameter of the insertion portion of the cystoscope.

7. A method for treating prostate gland according to claim 1, wherein the expansion step includes the steps of: before expanding the balloon, expanding a distal balloon provided in the bladder further distal than the balloon; and after expanding the distal balloon, moving the balloon and positioning it in the prostate gland.

8. The method for treating prostate gland according to claim 1, further comprising the step of inserting a verumontanum protection device for protecting the verumontanum into the urethra before the dilating step.

9. The prostate treatment method according to claim 8, wherein the verumontanum protection device protects the verumontanum with a protection sheet attached to a loop-shaped wire.

10. The method for treating prostate gland according to claim 1, comprising the steps of: expelling the balloon after injecting the drug; and inserting a Foley catheter into the urethra after expelling the balloon.

11. The method for treating prostate gland according to claim 1, wherein the drug comprises any one of ethanol, botulinum toxin, an antiandrogen, bromelain, and an FGFR inhibitor.

12. A treatment device comprising: a sheath having an elongated shape extending along an axial direction and having a lumen to which a fluid is supplied; and a balloon provided at the tip of the sheath and communicating with the lumen and capable of expanding, wherein the surface of the balloon is coated with a drug, and the surface of the balloon is provided with a plurality of microneedles.

13. The treatment device according to claim 12, wherein the maximum outer diameter of the expanded balloon in the radial direction perpendicular to the axial direction is 6.0 mm to 8.0 mm.

14. The treatment device according to claim 12, wherein the drug includes any one of ethanol, botulinum toxin, an antiandrogen, bromelain, and an FGFR inhibitor.

15. A method for treating a bladder tumor having a tumor protuberance and a tumor base, comprising: a cutting step for excising the tumor protuberance; and a freezing step for freezing the tumor base.

16. The method for treating a bladder tumor according to claim 15, wherein the cutting step includes excising the tumor protuberance and aspirating the tumor protuberance.

17. A method for treating bladder tumors as described in claim 16, wherein in the cutting step, the tumor protrusion is excised by an electrode provided at the opening of a suction line, and the excised tumor protrusion is suctioned through the suction line.

18. The method for treating a bladder tumor according to claim 15, wherein the freezing step freezes the tumor base by cryoablation.

19. The method for treating a bladder tumor according to claim 18, further comprising a confirmation step of measuring the depth of the frozen tumor base.

20. The method for treating a bladder tumor according to claim 15, further comprising a step of recovering the excised tumor protuberance.

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