Prostate tissue ablation systems and methods

Abstract

Ablation catheter and system including a catheter tip having at least one hollow needle extendable at an angle from a catheter body to ablate target prostate tissue while avoiding structures in the vicinity of the prostate tissue including the urethra, ejaculatory ducts, and rectal wall. A vapor ablation system including a pump, a catheter including a connection port at a proximal end of the catheter, a lumen in fluid communication with the connection port and configured to receive saline from the pump through the connection port, at least one electrode within the lumen, and at least one thermally conductive elongate member having a lumen and configured to be coupled with a distal tip of the catheter such that a proximal end of the at least one thermally conductive elongate member is at least 0.1 mm and no more than 60 mm from a distal-most electrode of the at least one electrode, and such that the lumen of the at least one thermally conductive elongate member is in fluid communication with the first lumen.

Description

[0001] Cross-referencing

[0002] This application is based on U.S. Provisional Application No. 62 / 893,062, filed August 28, 2019, entitled “Prostate and Endometrial Ablation System and Method”. This application is also based on U.S. Provisional Application No. 62 / 953,116, filed December 23, 2019, entitled “Prostate and Endometrial Ablation System and Method”. This application is also based on U.S. Provisional Application No. 63 / 025,867, filed May 15, 2020, entitled “Urogenital Ablation System and Method”.

[0003] This application relates to U.S. Patent Application No. 15 / 600,670, filed May 19, 2017, entitled “Ablation Conduit for an Integrated Cooling System,” which claims priority to U.S. Provisional Patent Application No. 62 / 425,144, filed November 22, 2016, entitled “Ablation Method and System,” and U.S. Provisional Patent Application No. 62 / 338,871, filed May 19, 2016, entitled “Cooling Coaxial Ablation Conduit.”

[0004] U.S. Patent Application No. 15 / 600,670 is also a continuation-in-part of U.S. Patent Application No. 15 / 144,768, "Induction Microvolume Heating System," filed May 2, 2016, and was published as U.S. Patent No. 10,064,697 on September 4, 2018. U.S. Patent Application No. 10,064,697 is a continuation-in-part of U.S. Patent Application No. 14 / 594,444, "Method and Apparatus for Tissue Ablation," filed January 12, 2015, and was published in February 2017. U.S. Patent No. 9,561,068 was published on February 7, 2017. This U.S. Patent No. 9,561,068 is a continuation-in-part application of U.S. Patent Application No. 14 / 158,687, filed on January 17, 2014, and was published as U.S. Patent No. 9,561,067 on February 7, 2017. U.S. Patent No. 9,561,067 claims priority to U.S. Provisional Patent Application No. 61 / 753,831, filed on January 17, 2013.

[0005] U.S. Patent Application No. 14 / 158,687 is a continuation-in-part of U.S. Patent Application No. 13 / 486,980, filed June 1, 2012, entitled “Method and Apparatus for Tissue Ablation,” and was published on February 7, 2017, as U.S. Patent No. 9,561,066, which in turn claims priority to U.S. Provisional Patent Application No. 61 / 493,344 of the same title, filed June 3, 2011.

[0006] U.S. Patent Application No. 13 / 486,980 is a continuation-in-part of U.S. Patent Application No. 12 / 573,939, filed on October 6, 2009, entitled “Method and Apparatus for Tissue Ablation,” which in turn claims priority to U.S. Provisional Patent Application No. 61 / 102,885, filed on October 6, 2008, with the same title.

[0007] All of the above-mentioned applications are incorporated herein by reference in their entirety and are thus part of this invention. Technical Field

[0008] This specification relates to systems and methods for generating and delivering ablation therapy vapor. More specifically, this specification relates to systems and methods (including a vapor ablation catheter and a vapor generating device) for applying ablation therapy to specific areas of the prostate, endometrium, and bladder. Background Technology

[0009] Benign prostatic hyperplasia (BPH) refers to an enlarged prostate. This enlargement can be non-cancerous and occurs with age, commonly seen in men. However, the enlarged prostate caused by BPH can lead to urethral compression, thus obstructing the flow of urine from the bladder through the urethra. Anatomically, the middle and lateral lobes are usually enlarged due to their high glandular content. The anterior lobe has very little glandular tissue and is rarely enlarged. Prostate cancer typically occurs in the posterior lobe, so an irregular outline can be discerned during each rectal examination.

[0010] The earliest microscopic signs of prostate hyperplasia (BPH) typically begin in the periurethral zone (PuZ) (proximal to the urethra) of men aged 30 to 50. In BPH, most growth occurs in the transition zone (TZ). In addition to these two typical areas, the peripheral zone (PZ) is also involved to a lesser extent. Prostate cancer usually occurs within the PZ. However, to rule out TZ cancer, BPH nodules (usually originating from the TZ) are frequently biopsied. BPH is nodular hyperplasia, not diffuse hyperplasia, and it affects both the TZ and PuZ of the prostate. In clinical practice, adenomas originating from the TZ form lateral lobes, while adenomas originating from the PuZ form median lobes.

[0011] Transurethral needle ablation (TUNA) is a procedure used to treat symptoms caused by benign prostatic hyperplasia (BPH). This ablation procedure treats excess prostate tissue that is causing BPH symptoms.

[0012] Approximately 8% of men aged 50-70 are diagnosed with prostate cancer, a disease that tends to develop as men age. Men with prostate cancer often experience symptoms similar to those of benign prostatic hyperplasia (BPH) and may also experience sexual problems related to prostate cancer. Generally, the prognosis for men with early-stage prostate cancer is good. Treatment options include active surveillance, surgery, radiation therapy, and chemotherapy, depending on the severity of the disease and the patient's age.

[0013] Dysfunctional uterine bleeding (DUB) or menorrhagia affects 30% of women of reproductive age. The associated symptoms have a significant impact on women's health and quality of life. It is usually treated with endometrial ablation or uterine ablation. The intervention rate for these women is high. Nearly 30% of American women undergo uterine ablation before age 60, with 50-70% of these women undergoing the procedure due to menorrhagia or DUB. Endometrial ablation technology is FDA-approved for women with abnormal uterine bleeding and intramural fibroids smaller than 2 cm. Studies have shown that the presence of submucosal fibroids and a large uterus reduces the effectiveness of standard endometrial ablation. Of the five FDA-approved global ablation devices (Thermachoice, hydrothermal ablation, Novasure, Her Option, and microwave ablation (MEA)), only microwave ablation is approved for submucosal fibroids smaller than 3 cm that do not obstruct the endometrial cavity. Furthermore, microwave ablation can be used for large uteruses up to 14 cm wide.

[0014] Bladder cancer is a rare form of cancer caused by abnormal growth of cells within the bladder. These abnormal cells form a tumor. Figure 22A This diagram shows the different stages of bladder cancer known in the medical field. Referring to this figure, in stage I (Tis), bladder tumor 2202 is located above the mucosa 2204 layer within the bladder 2200. In stage II (Ta), tumor 2206 has spread to the mucosa 2204. In stage III (T1), tumor 2208 has spread to the submucosal layer 2210 below the mucosa 2204. In stage IV (T2), tumor 2212 has spread to the superficial muscle layer 2214 below the submucosal layer 2210. In stage V (T3a), tumor 2216 has spread to the deep muscle layer 2218 below the superficial muscle layer 2214. In stage VI (T3b), tumor 2220 has spread to the perivesical fat layer 2222 beyond the deep muscle layer 2218. In stage VII (T4b), tumor 2224 has spread to the area outside the perivesical fat layer 2222. In stage 8 (T4a), the tumor 2226 has spread to extravesical structures 2228 outside the bladder 2200. Ablation techniques can be used to treat stage 1 to 4 cancers, i.e., non-muscle-invasive or superficial bladder cancers. Furthermore, ablation techniques can be used to alleviate stage 5 and later cancers, i.e., invasive bladder cancers.

[0015] The bladder stores urine produced by the kidneys, which flows down into the bladder through ducts called ureters. From the bladder, urine flows into the urethra, which then expels it from the body. Some people suffer from overactive bladder (OAB), a condition that causes frequent urination even when the bladder is not full. Ablation techniques can be used to treat OAB patients.

[0016] Because the bladder is used to store urine, the vapor produced by the ablation method may lose its effectiveness when there is urine above the tissue to be ablated. Therefore, it is desirable to provide a method for ablating bladder tissue after completely removing fluids, water, and / or urine from the target tissue.

[0017] Ablation techniques relevant to this specification involve removing or destroying human tissue by introducing destructive agents such as radiofrequency energy, laser energy, ultrasound energy, cryogenic agents, or steam. Ablation is commonly used to remove lesions or excess tissue, such as, but not limited to, cysts, polyps, tumors, hemorrhoids, and other similar lesions. Ablation techniques can be used in conjunction with chemotherapy, radiotherapy, surgery, and BCG vaccination.

[0018] Steam-based ablation systems (such as those disclosed in U.S. Patents 9,615,875, 9,433,457, 9,376,497, 9,561,068, 9,561,067, and 9,561,066) disclose ablation systems that deliver steam to a tissue target in a controlled manner through one or more lumens. These steam-based ablation systems all present the problem of potential overheating or burns to healthy tissue. Steam passing through the intracavitary channels can heat the channel surfaces and cause overheating of the outer surfaces of the medical instruments (except for the surgical instrument tip itself). Therefore, a physician may unintentionally burn healthy tissue when an external part of the device (other than the distal operating end of the instrument) comes into contact with it. U.S. Patents 9,561,068, 9,561,067, and 9,561,066 are incorporated herein by reference in their entirety.

[0019] Furthermore, rapid cooling of the treated area is typically required after the use of steam or other ablative agents. However, current systems rely heavily on natural cooling processes, which prolongs treatment time. Alternatively, current medical treatments may involve rinsing an area with liquid, but this requires the use of separate medical instruments, complicating the procedure and also extending treatment time.

[0020] Therefore, it is necessary to integrate steam-based ablation devices into the device's own safety mechanisms to prevent unnecessary ablation during use. Furthermore, it is desirable to provide a method to enhance the natural cooling process, thereby reducing the total treatment time and increasing the steam delivery time. Finally, it is desirable to provide an easily implementable cooling mechanism that can deliver liquid to cool the treatment area without relying on separate medical instruments. Summary of the Invention

[0021] This specification discloses a vapor ablation system for ablation of prostate tissue in a patient, wherein the system comprises: at least one pump; a catheter extending between a proximal end and a distal tip, wherein the catheter includes: a connection port located at the proximal end of the catheter, wherein the catheter is in fluid communication with the at least one pump through the connection port; a first lumen in fluid communication with the connection port and capable of receiving saline solution from the at least one pump through the connection port; at least one electrode located within the first lumen; at least one thermally conductive elongated member having a lumen and being coupled to the distal tip of the catheter such that the proximal end of the at least one thermally conductive elongated member is at least 0.1 mm and no more than 60 mm away from the distal electrode of the at least one electrode, while the lumen of the at least one thermally conductive elongated member is in fluid communication with the first lumen; and a controller having at least one processor for data communication with the at least one pump, wherein the controller, upon activation, can: control the delivery of saline solution into the first lumen; and control the delivery of current to the at least one electrode within the first lumen.

[0022] Optionally, the at least one thermally conductive elongated member includes a needle and a needle connecting component. The needle may have a tapered distal tip. The needle and the needle connecting component may be made of the same material, such as stainless steel. The proximal portion of the needle may be threaded to the distal end of the needle connecting component.

[0023] Optionally, the vapor ablation system further includes a needle chamber coupled to the distal tip of the catheter and extendable along the length of the catheter. The needle chamber may have an outer surface and an inner lumen defining an inner surface, wherein the outer surface comprises a first material, and the inner surface comprises a second material, wherein the first material and the second material are different. The first material may be a polymer, and the second material may be a metal. The needle chamber may have an inner lumen defining an inner surface, wherein the inner lumen is curved to accommodate a curved needle. The at least one thermally conductive elongated member may include a needle, wherein, in a pre-deployed state, the needle chamber is positioned above the needle, and in a deployed state, the needle chamber is retractable towards the proximal end of the catheter while the needle is positioned outside the needle chamber. Optionally, the needle can be further adjusted to a pre-needle chamber state, wherein in the pre-needle chamber state, the needle has a first curvature; in the pre-deployment state, the needle has a second curvature; and in the deployed state, the needle has a third curvature, wherein the first curvature is different from the second and third curvatures, and wherein the second and third curvatures are different. Optionally, the needle can be further adjusted to a pre-needle chamber state, wherein in the pre-needle chamber state, the needle has a first curvature; in the pre-deployment state, the needle has a second curvature; and in the deployed state, the needle has a third curvature, wherein the first curvature is greater than the second and third curvatures, and wherein the third curvature is greater than the second curvature. Optionally, in the deployed state, the needle can extend outward from the outer surface of the catheter at an angle between 30° and 90°.

[0024] Optionally, the at least one thermally conductive elongated member includes a needle and a needle connection component, wherein the needle includes an inner channel in fluid communication with the first lumen and a port, allowing vapor to enter the external environment from the inner channel.

[0025] Optionally, the at least one thermally conductive elongated member includes a plurality of needles.

[0026] Optionally, the at least one thermally conductive elongated member includes a needle extending from a proximal end to a tapered distal end, and further includes an insulating material positioned above the needle length. The insulating material is adjusted to cover at least 5% of the needle length (starting from the proximal end), wherein the insulating material is adjusted to cover no more than 90% of the needle length (starting from the proximal end).

[0027] Optionally, the controller can be adjusted to control the delivery of saline solution into the first lumen and to control the delivery of current to the at least one electrode, so as to perform continuous circumferential ablation of the prostatic urethra of patients with a percentage greater than 0% and a percentage less than 75%.

[0028] Optionally, the controller can be adjusted to control the delivery of saline solution into the first lumen and to control the delivery of current to the at least one electrode, so that the patient's ejaculatory ducts of greater than 0% and less than 75% can be continuously circumferentially ablated.

[0029] Optionally, the controller can be adjusted to control the delivery of saline solution into the first lumen and to control the delivery of current to the at least one electrode, thereby ablating rectal wall thicknesses greater than 0% and less than 75%.

[0030] Optionally, the controller can be adjusted to control the delivery of saline solution into the first lumen and to control the delivery of current to the at least one electrode, so as to cause continuous circumferential ablation of one of the prostatic ejaculatory ducts and central zone with a percentage greater than 0% and less than 75%.

[0031] Optionally, the controller can be adjusted to control the delivery of saline solution into the first lumen and to control the delivery of current to the at least one electrode, thereby ablating the patient's prostate transition zone and ablating more than 0% and less than 75% of the patient's anterior fibromuscular matrix.

[0032] This specification also discloses a vapor ablation system for treating diseases, wherein the system includes: at least one pump; a catheter in fluid communication with the at least one pump via a catheter connection port, wherein the proximal end of the catheter is connected to the catheter connection port, thereby enabling fluid communication between the catheter and the at least one pump, wherein the catheter includes: at least one lumen for transporting saline solution delivered from the at least one pump; at least one electrode located within the at least one lumen; a plurality of openings near the distal end of the catheter; a plurality of thermally conductive members extending through the plurality of openings and contracting, wherein the plurality of thermally conductive members are hollow members, wherein each of the plurality of thermally conductive members includes a port for delivering vapor; and a controller having at least one processor for data communication with the at least one pump, wherein, upon activation, the controller can: control the delivery of saline solution into the at least one lumen in the catheter; control the delivery of current to the at least one electrode within the at least one lumen of the first catheter; and control the vapor generated by the saline solution.

[0033] Optionally, the plurality of heat-conducting components are needles.

[0034] Optionally, the plurality of heat-conducting components extend from the conduit at an angle between 30° and 90°.

[0035] Optionally, the system is used to ablate a patient's prostate tissue through the patient's urethra, wherein greater than 0% and less than 75% of the patient's prostate urethra are continuously ablated in a circumferential manner.

[0036] Optionally, the system is used to ablate a patient's prostate tissue through the patient's urethra, wherein more than 0% and less than 75% of the patient's ejaculatory ducts are continuously ablated in a circumferential manner.

[0037] Optionally, the system is used to ablate a patient's prostate tissue through the patient's rectal wall, wherein the patient's rectal wall thickness is ablated to greater than 0% and less than 75%.

[0038] Optionally, the system can ablate at least one central or transitional zone of the prostate, while continuously circumferentially ablating greater than 0% and less than 75% of the prostatic urethra.

[0039] Optionally, the system can ablate at least one central or transitional zone of the prostate, while continuously ablating greater than 0% and less than 75% of the ejaculatory ducts in a circular pattern.

[0040] Optionally, the system can ablate the middle lobe of the prostate, while simultaneously ablating one of the following continuous circumferences: greater than 0% and less than 75% of the prostatic ejaculatory ducts and central zone.

[0041] Optionally, the system can ablate the central zone of the prostate while simultaneously ablating greater than 0% and less than 75% of the anterior fibromuscular matrix (AFS).

[0042] This specification also discloses a method for ablation of prostate tissue in a patient, comprising: providing an ablation system including: at least one pump; a catheter in fluid communication with the at least one pump, wherein a proximal end of the catheter is connected to a catheter connection port, thereby enabling fluid communication between the catheter and the at least one pump, wherein the catheter includes: at least one lumen for transporting saline solution delivered from the at least one pump; at least one electrode located within the at least one lumen; multiple openings near the distal end of the catheter; and multiple thermally conductive members that extend through and contract through the multiple openings, wherein the multiple thermally conductive members are hollow members, wherein the multiple Each of the heat-conducting components includes a port for delivering vapor; and a controller having at least one processor for data communication with the at least one pump, wherein the controller, upon activation, can control the delivery of saline solution into the at least one lumen in the catheter; wherein the electrodes can receive current and convert the saline solution into ablation vapor; insert the catheter into the patient's urethra; pass the heat-conducting component through the plurality of openings and into the prostate tissue; and program the controller to control the delivery of the vapor to circumferentially ablate greater than 0% and less than 75% of the prostate tissue or adjacent tissue.

[0043] Optionally, the heat-conducting component includes a needle.

[0044] Optionally, the prostate tissue or adjacent tissue is the prostatic urethra.

[0045] Optionally, the prostate tissue or adjacent tissue is the ejaculatory duct.

[0046] Optionally, the prostate tissue or adjacent tissue is the rectal wall.

[0047] This specification also discloses a vapor ablation system for treating diseases, wherein the system includes: at least one pump; a coaxial catheter for insertion into a patient's vagina toward the cervix, the coaxial catheter including: an outer catheter for entering the internal os of the patient's cervix; and an inner catheter for entering the patient's uterus, concentric with the outer catheter and slidable within the outer catheter, wherein the inner catheter is in fluid communication with the at least one pump via a catheter connection port, wherein the proximal end of the inner catheter is connected to the catheter connection port, thereby enabling fluid communication between the inner catheter and the at least one pump, wherein the inner catheter includes: at least one lumen for transporting saline solution delivered from the at least one pump; and at least one electrode located at the... The device comprises: at least one lumen; at least two positioning members separated along the length of the inner catheter, wherein the distal positioning member is advanced forward until its distal end contacts the fundus of the uterus, and the proximal positioning member is advanced forward to approach the internal os of the patient and form a partial closure or contact with the internal os; and at least one opening adjacent to the distal positioning member of the inner catheter; a controller having at least one processor that communicates data with the at least one pump, wherein, upon activation, the controller can: control the delivery of saline solution into the at least one lumen within the coaxial catheter; control the delivery of current to the at least one electrode within the at least one lumen of the inner catheter; and control the vaporization generated by the saline solution.

[0048] Optionally, the inner catheter is used to measure the length of the patient's uterine cavity. Optionally, the measured length is used to determine the amount of vapor used for ablation.

[0049] Optionally, the partial closure is a temperature-dependent closure, which will break down once the internal temperature of the uterine closure exceeds 90°C.

[0050] Optionally, the partial closure is a pressure-dependent closure, which will break down once the internal temperature of the uterine closure exceeds 101°C and the pressure exceeds 0.5 psi. Optionally, the partial closure is a pressure-dependent closure, which will break down once the internal temperature of the uterine closure exceeds 102°C and the pressure exceeds 1.0 psi. Optionally, the partial closure is a pressure-dependent closure, which will break down once the internal temperature of the uterine closure exceeds 103°C and the pressure exceeds 1.5 psi.

[0051] Optionally, the controller controls the vapor to a certain amount, maintaining the endometrial pressure below 50 mm Hg and above atmospheric pressure by 10% (at least one of these conditions must be met). Optionally, the controller controls the vapor to a certain amount, maintaining the endometrial pressure below 30 mm Hg and above atmospheric pressure by 10% (at least one of these conditions must be met). Optionally, the controller controls the vapor to a certain amount, maintaining the endometrial pressure below 15 mm Hg and above atmospheric pressure by 10% (at least one of these conditions must be met).

[0052] Optionally, at least one of the inner and outer catheters includes a venting member for venting uterine air. Optionally, the venting member includes a groove.

[0053] Optionally, the proximal positioning member includes at least one opening for uterine gas drainage.

[0054] Optionally, the inner catheter includes a pressure sensor to maintain the vapor pressure within the uterus below 50 mmHg. Optionally, the inner catheter includes a pressure sensor to maintain the vapor pressure within the uterus below 30 mmHg. Optionally, the inner catheter includes a pressure sensor to maintain the vapor pressure within the uterus below 15 mmHg.

[0055] Optionally, each positioning element includes an uncovered wire mesh.

[0056] This specification also discloses a method for ablation of prostate tissue in a patient, comprising: providing an ablation system including: at least one pump; a catheter in fluid communication with the at least one pump, wherein a proximal end of the catheter is connected to a catheter connection port, thereby enabling fluid communication between the catheter and the at least one pump, wherein the catheter includes: at least one lumen for transporting saline solution delivered from the at least one pump; at least one positioning member located at the distal end of the at least one lumen; at least one electrode located within the at least one lumen; an outer sheath covering the at least one lumen; a plurality of openings located on the outer sheath near the distal end of the catheter; and a plurality of thermally conductive members that extend through and retract through the plurality of openings, wherein the plurality of thermally conductive members are hollow members, wherein the plurality of... Each component in the heat-conducting member includes a port for delivering vapor; and a controller having at least one processor for data communication with the at least one pump, wherein the controller, upon activation, controls the delivery of saline solution into the at least one lumen in the catheter; wherein the electrodes can receive current and convert the saline solution into ablation vapor; the distal end of the catheter is inserted into the patient's urethra; the distal end of the catheter is extended into the patient's bladder; the outer sheath contracts, exposing the at least one lumen and the positioning member; the positioning member is extended; the heat-conducting member passes through the plurality of openings and enters the prostate tissue; the controller is programmed to control the delivery of the vapor, causing circumferential ablation of greater than 0% and less than 75% of the prostate tissue or adjacent tissue.

[0057] Optionally, the heat-conducting component includes a needle.

[0058] Optionally, the prostate tissue or adjacent tissue is the prostatic urethra.

[0059] Optionally, the prostate tissue or adjacent tissue is the ejaculatory duct.

[0060] Optionally, the prostate tissue or adjacent tissue is the rectal wall.

[0061] Optionally, extending the positioning member includes placing the positioning member close to the bladder neck.

[0062] Optionally, the extended positioning member includes placing the positioning member within the prostatic urethra.

[0063] This specification also discloses a method for ablation of endometrial tissue in a patient, comprising: providing an ablation system including: at least one pump; a coaxial catheter for insertion into the patient's vagina toward the cervix, the coaxial catheter including: an outer catheter for entering the internal os of the patient's cervix; and an inner catheter for entering the patient's uterus, concentric with the outer catheter and slidable within the outer catheter, wherein the inner catheter is in fluid communication with the at least one pump via a catheter connection port, wherein the proximal end of the inner catheter is connected to the catheter connection port, thereby enabling fluid communication between the inner catheter and the at least one pump, wherein the inner catheter includes: at least one lumen for transporting saline solution delivered from the at least one pump; at least one electrode located within the at least one lumen; and at least two positioning members separated along the length of the inner catheter, wherein the distal positioning member is advanced forward until it reaches the distal end of the uterus. The distal end of the lateral positioning member contacts the fundus of the uterus, and the proximal positioning member is advanced forward to approach the patient's internal os and form a partial closure with the internal os; and multiple openings are located on the internal catheter and between the distal and proximal positioning members for delivering steam; a controller having at least one processor that communicates data with the at least one pump, wherein the controller, upon activation, controls the delivery of saline solution into at least one lumen within the coaxial catheter and controls the steam generated by the saline solution; the distal end of the catheter is inserted until the distal end of the distal positioning member contacts the fundus of the uterus, and the proximal positioning member is advanced forward to position it near the patient's internal os; the distal positioning member is extended; the proximal positioning member is extended to form a partial closure within the internal os; and the controller is programmed to control the delivery of the endometrial tissue ablation steam.

[0064] Optionally, the distal positioning member and the proximal positioning member are funnel-shaped.

[0065] This specification also discloses an ablation method for the middle lobe of the prostate in patients with middle lobe hyperplasia. The method includes: inserting a catheter with at least one needle into the patient's spongy urethra and through the prostatic urethra, such that the distal end of the catheter is located in the patient's bladder; extending the at least one needle from the distal end of the catheter and passing the needle through the bladder or bladder neck wall into the middle lobe; delivering an ablation agent into the middle lobe through the at least one needle to ablate the prostate tissue; and controlling the flow rate of the ablation agent using a controller to maintain the pressure in the bladder and middle lobe below 5 atm.

[0066] Optionally, the catheter further includes at least one positioning member, and the method further includes: deploying the at least one positioning member before inserting the at least one needle, placing the catheter into the bladder, and stabilizing the at least one needle.

[0067] This specification also discloses an ablation method for the middle lobe of the prostate in patients with middle lobe hyperplasia. The method includes: providing an ablation system comprising: at least one pump; a catheter in fluid communication with the at least one pump, wherein a proximal end of the catheter is connected to a catheter connection port, thereby enabling fluid communication between the catheter and the at least one pump; wherein the catheter includes: at least one lumen for transporting saline solution delivered from the at least one pump; at least one electrode located within the at least one lumen; an outer sheath covering the at least one lumen; a plurality of openings located on the outer sheath near the distal end of the catheter; and a plurality of thermally conductive members that extend through and retract through the plurality of openings, wherein the plurality of thermally conductive members are hollow members. Each of the thermally conductive components includes a port for delivering vapor; and a controller having at least one processor that communicates data with the at least one pump, wherein the controller, upon activation, controls the delivery of saline solution into the at least one lumen of the catheter; wherein the electrodes are capable of receiving current and converting the saline solution into ablation vapor; the catheter is inserted into the patient's spongy urethra and through the prostatic urethra, with the distal end of the catheter located within the patient's bladder; the plurality of thermally conductive components extend from the distal end of the catheter, through the bladder wall, and into the middle lobe; an ablation agent is delivered into the middle lobe through the plurality of thermally conductive components to ablate prostatic tissue; the controller is programmed to control the flow rate of the ablation agent and maintain pressure within the bladder and middle lobe below 5 atm.

[0068] Optionally, the catheter further includes at least one positioning member, and the method further includes: deploying the at least one positioning member before inserting the plurality of heat-conducting members, placing the catheter into the bladder, and stabilizing the plurality of heat-conducting members.

[0069] This specification also discloses an ablation method for at least one target area in or near the urethra and bladder of a patient, the method comprising: providing an ablation system including: at least one pump; a catheter in fluid communication with the at least one pump, wherein a proximal end of the catheter is connected to a catheter connection port, thereby enabling fluid communication between the catheter and the at least one pump, wherein the catheter includes: at least one lumen for transporting saline solution delivered from the at least one pump; at least one electrode located within the at least one lumen; a plurality of openings near the distal end of the catheter; and a plurality of thermally conductive members that extend through and retract through the plurality of openings, wherein the plurality of thermally conductive members... The component is a hollow component, wherein each of the plurality of heat-conducting components includes a port for delivering vapor; and a controller having at least one processor for data communication with the at least one pump, wherein the controller, upon activation, can control the delivery of saline solution into the at least one lumen in the catheter; wherein the electrodes can receive current and convert the saline solution into ablation vapor; drain fluid from the urethra and bladder near the target area; insert the catheter into the patient's ureter; extend the heat-conducting components through the plurality of openings into or near the target area; and program the controller to control the vapor delivery to ablate the target area.

[0070] Optionally, the target area is at least one of tissue, tumor, or nerve. Optionally, the target area is tissue within the urethra and bladder. Optionally, the target area is located within the extravesical space below the patient's trigone. Optionally, the target area is located within one of the patient's bladder neck, internal urethral sphincter (IUS), and the IUS and bladder neck nerves.

[0071] Optionally, fluid drainage includes urination from the urethra and bladder.

[0072] Optionally, draining the fluid includes performing at least one of the following steps: removing urine from the urethral bladder; blowing air into the urethral bladder; and positioning the patient away from the dependent portion of the urethral bladder to drain the urine from the urethral bladder.

[0073] Optionally, the heat-conducting component includes a needle.

[0074] Optionally, the method further includes applying a positioning component near the target area and surrounding at least a portion of the target area.

[0075] Optionally, the method further includes maintaining the intravesical pressure in the urethra below 5 atm.

[0076] This specification also discloses an ablation method for at least one target area in or near the urethra and bladder of a patient. The method includes: providing an ablation system comprising: at least one pump; a coaxial catheter for insertion into the patient's ureter, the coaxial catheter comprising: an outer catheter for insertion into the patient's ureter; and an inner catheter for insertion into the patient's ureter, concentric with and slidable within the outer catheter, wherein the inner catheter is in fluid communication with the at least one pump via a catheter connection port, wherein the proximal end of the inner catheter is connected to the catheter connection port, thereby enabling fluid communication between the inner catheter and the at least one pump, wherein the inner catheter comprises: at least one lumen for transporting saline solution delivered from the at least one pump; at least one electrode located within the at least one lumen; and at least one positioning member along... The inner catheter is positioned along its length, wherein at least one positioning member is advanced forward until its distal end surrounds the target area; and at least one opening is located near the positioning member of the inner catheter; a controller having at least one processor that communicates data with the at least one pump, wherein, upon activation, the controller can: control the delivery of saline solution into at least one lumen within the coaxial catheter; control the delivery of current to at least one electrode within the at least one lumen of the inner catheter; and control the vapor generated by the saline solution; drain fluid from the urethra and bladder near the target area; insert the coaxial catheter into the patient's ureter; apply the positioning member near the target area to surround at least a portion of the target area; and program the controller to control the vapor delivery to ablate the target area.

[0077] Optionally, the target area is at least one of tissue, tumor, or nerve. Optionally, the target area is tissue inside the urethra and bladder. Optionally, fluid drainage includes urination from the urethra and bladder.

[0078] Optionally, draining the fluid includes performing at least one of the following steps: removing urine from the urethral bladder; blowing air into the urethral bladder; positioning the patient so that the target area is away from the dependent part of the urethral bladder, thereby draining urine from the urethral bladder.

[0079] Optionally, the method further includes maintaining the intravesical pressure in the urethra below 5 atm.

[0080] The above and other embodiments of the present invention will be described in more detail in the following drawings and detailed description. Attached Figure Description

[0081] Referring to the specific embodiments and the accompanying drawings will help to better understand and further appreciate the above and other features and advantages of the present invention, wherein:

[0082] Figure 1A The ablation system described in the embodiments of this specification is shown;

[0083] Figure 1B This is a cross-sectional view of a flexible heating chamber according to one embodiment of this specification;

[0084] Figure 1C This is a transverse and longitudinal sectional view of the first and second electrode arrays of the flexible heating chamber according to one embodiment of this specification;

[0085] Figure 1D This specification describes a heating chamber comprising assembled first and second electrode arrays as one embodiment. Figure 1B A cross-sectional view of ( );

[0086] Figure 1E This specification describes a heating chamber comprising assembled first and second electrode arrays as one embodiment. Figure 1B A longitudinal sectional view;

[0087] Figure 1F These are two heating chambers arranged in series in the tip of the conduit, as described in one embodiment of this specification. Figure 1B The first portrait view;

[0088] Figure 1G These are two heating chambers arranged in series in the tip of the conduit, as described in one embodiment of this specification. Figure 1B The second longitudinal view;

[0089] Figure 1H This specification shows an embodiment of a heating chamber ( Figure 1B Multi-lumen balloon catheter;

[0090] Figure 1I This specification shows an embodiment comprising two heating chambers ( Figure 1B Multi-lumen balloon catheter;

[0091] Figure 1J This specification shows a conduit having proximal and distal positioning components and an electrode heating chamber as described in an embodiment of the present specification;

[0092] Figure 1K This specification illustrates an ablation system for prostate tissue ablation as described in an embodiment.

[0093] Figure 1L The catheter for prostate tissue ablation described in the embodiments of this specification is shown;

[0094] Figure 1M This specification shows a system for prostate tissue ablation according to another embodiment;

[0095] Figure 1NThis specification illustrates an ablation system for endometrial tissue ablation as described in an embodiment.

[0096] Figure 10 The catheter for endometrial tissue ablation described in the embodiments of this specification is shown;

[0097] Figure 1P This specification shows a system for endometrial tissue ablation according to another embodiment;

[0098] Figure 1Q This specification shows a controller used in conjunction with an ablation system according to one embodiment;

[0099] Figure 1R This specification shows a system for prostate tissue ablation according to another embodiment;

[0100] Figure 1S The needle connection components of the system for prostate tissue ablation described in some embodiments of this specification are shown;

[0101] Figure 1T The needle chamber of the system for prostate tissue ablation described in some embodiments of this specification is shown;

[0102] Figure 2A This specification shows a single-lumen double-balloon catheter according to one embodiment, including an embedded heating element;

[0103] Figure 2B This specification shows a coaxial lumen double balloon catheter according to one embodiment, including an embedded heating element;

[0104] Figure 3A The typical anatomical structure of the prostate region is shown for illustrative purposes;

[0105] Figure 3B This is an exemplary transparent view of the prostate anatomy, highlighting the peripheral zone and other zones surrounding the prostate.

[0106] Figure 3C It is a transparent oblique top view of the prostate, showing the various zones and the prostatic urethra;

[0107] Figure 4A This specification shows a water-cooled conduit according to another embodiment;

[0108] Figure 4B yes Figure 4A A cross-sectional view of the tip portion of the water-cooled conduit shown.

[0109] Figure 4C Showing with Figure 1M An embodiment of the distal end of the catheter used in conjunction with the system shown;

[0110] Figure 4D Showing with Figure 1M Other embodiments of the distal end of the catheter used in conjunction with the system shown;

[0111] Figure 4E This specification shows some embodiments of the method for covering Figure 4C and Figure 4D An embodiment of the slit cover with the shown opening;

[0112] Figure 4F An embodiment of the positioning member described in this specification is shown, located at the distal end of the ablation catheter for placing the ablation catheter in the prostatic urethra;

[0113] Figure 4G This specification shows an exemplary embodiment of an ablation catheter with its distal end penetrating the prostatic urethra;

[0114] Figure 4H This specification shows an exemplary embodiment of the ablation catheter inserted into the bladder at its distal end;

[0115] Figure 4I This specification shows an exemplary embodiment of an ablation catheter whose distal end further penetrates into the bladder;

[0116] Figure 4J This specification shows an exemplary embodiment of the positioning member that unfolds and retracts at the distal end of the ablation catheter to locate near the bladder neck or urethra.

[0117] Figure 4K This specification shows an exemplary embodiment of a needle extending from the distal end of an ablation catheter into the prostate tissue;

[0118] Figure 4L This specification illustrates an exemplary embodiment in which the ablative agent described herein is introduced into prostate tissue via one or more needles;

[0119] Figure 4M This specification shows an alternative embodiment of the ablation catheter inserted into the prostatic urethra, with a positioning member located near the needle at the distal end of the catheter;

[0120] Figure 4N This illustrates the insertion of a needle located at the distal end of the ablation catheter into the prostate tissue, as described in the alternative embodiments above.

[0121] Figure 4O This is a flowchart illustrating the use of an ablation catheter to ablate a patient's prostate as described in the embodiments of this specification, listing the steps involved;

[0122] Figure 5A This specification illustrates an embodiment of prostate ablation using an ablation device in the male urinary system.

[0123] Figure 5B This specification illustrates an embodiment of transurethral prostate ablation of an enlarged prostate in the male urinary system using an ablation device;

[0124] Figure 5C This specification illustrates another embodiment of transurethral prostate ablation of an enlarged prostate in the male urinary system using an ablation device;

[0125] Figure 5D This is a flowchart of a transurethral ablation of an enlarged prostate using an ablation catheter, as described in one embodiment of this specification, and lists the steps involved in the process;

[0126] Figure 5E This specification illustrates an embodiment of transrectal prostate ablation using an ablation device in the male urinary system;

[0127] Figure 5F This specification illustrates a different embodiment of the use of a coaxial ablation device with positioning components for transrectal prostate ablation of an enlarged prostate in the male urinary system;

[0128] Figure 5G It is a close-up view of the distal end of the catheter and the tip of the ablation device needle;

[0129] Figure 5H This is a flowchart illustrating transrectal ablation of an enlarged prostate using an ablation catheter, as described in one embodiment of this specification, and lists the steps involved in the process;

[0130] Figure 6A This specification shows an embodiment of the ablation catheter;

[0131] Figure 6B yes Figure 6A A cross-sectional view of the tip of the ablation catheter shown;

[0132] Figure 6C An embodiment of the use is shown. Figure 6A The ablation catheter shown is used for transurethral prostate ablation;

[0133] Figure 6D This is a flowchart of transurethral ablation of enlarged prostate as described in one embodiment, listing the steps involved in the process;

[0134] Figure 7A This specification shows an ablation catheter according to another embodiment;

[0135] Figure 7B yes Figure 7A A cross-sectional view of the tip of the ablation catheter shown;

[0136] Figure 7C An embodiment of the use is shown. Figure 7A The ablation catheter shown is used for transurethral prostate ablation;

[0137] Figure 7D This is a flowchart of transurethral ablation of enlarged prostate as described in one embodiment, listing the steps involved in the process;

[0138] Figure 8A An embodiment of the positioning component of the ablation catheter is shown, to which multiple heat-conducting components are connected;

[0139] Figure 8B An embodiment of the positioning component of the ablation catheter is shown, to which multiple hollow heat-conducting components are connected;

[0140] Figure 9 This is a flowchart of an embodiment of a method for ablating tissue using a needle catheter device;

[0141] Figure 10 This is a flowchart of a method for ablating submucosal tissue using a needle catheter device according to one embodiment of this specification;

[0142] Figure 11A An exemplary embodiment of the modified needle described in this specification is shown;

[0143] Figure 11B Different embodiments of the needle described in this specification are shown;

[0144] Figure 11C This specification shows some embodiments of the method described using a pair of needles (e.g.) Figure 11B An exemplary process for delivering ablative agent through a hollow opening on the edge of the double needle shown;

[0145] Figure 11D Exemplary depths of needles with different curvatures as described in some embodiments of this specification are shown;

[0146] Figure 11E This specification shows some embodiments of the target relative to Figure 11D The exemplary depth of the needle shown;

[0147] Figure 11F The needles described in some embodiments of this specification are shown. Figure 11E An exemplary length of the needle body, which extends in a straight line from the port to the farthest distance reached by the needle body;

[0148] Figure 11GThese are different views of the single-needle assembly extending from the port as described in some embodiments of this specification;

[0149] Figure 11H This is another horizontal view of the needle described in some embodiments of this specification, showing one or more holes on the sharp edge;

[0150] Figure 11I These are different views of the dual-needle assembly extending from the port as described in some embodiments of this specification;

[0151] Figure 11J This is a different view of another double-pin assembly extending from the port as described in some embodiments of this specification;

[0152] Figure 11K This specification shows the heat insulation layer on the single-needle structure and the double-needle structure described in some embodiments;

[0153] Figure 11L This specification shows a single-needle structure with a heat-insulating layer in prostate tissue as described in some embodiments;

[0154] Figure 11M This specification shows a single-needle structure with a heat-insulating layer inside a uterine fibroid, as described in some embodiments.

[0155] Figure 11N This specification shows a dual-needle structure described in some embodiments, wherein two needles are inserted into different lobes of the prostate.

[0156] Figure 11O An exemplary embodiment of the steerable guide shaft described in some embodiments of this specification is shown;

[0157] Figure 11P This specification shows a needle with an open tip as described in some embodiments;

[0158] Figure 11Q This illustration shows an alternative embodiment of the needle described in this specification, which has a closed tip and a hole or opening along the non-insulated length of the needle;

[0159] Figure 12 This specification illustrates an embodiment of transurethral prostate ablation using an ablation device;

[0160] Figure 13A An embodiment of the positioning component of an ablation catheter is shown, wherein a needle is connected to the catheter body;

[0161] Figure 13B Another embodiment of the positioning component of the ablation catheter is shown;

[0162] Figure 13CThis image shows a cross-section of the distal tip of the catheter as described in one embodiment of this specification;

[0163] Figure 14 An embodiment of a handle mechanism that can be used to deploy and retract the ablation needle at different insertion depths is shown;

[0164] Figure 15A This is a flowchart of a prostate tissue ablation method according to one embodiment of this specification;

[0165] Figure 15B This is a flowchart of a prostate tissue ablation method according to another embodiment of this specification;

[0166] Figure 15C This specification shows a compressible catheter according to one embodiment, wherein a deployable member enters the prostatic urethra;

[0167] Figure 15D This specification shows a deployable component of a catheter in a deployed state according to one embodiment of the catheter, wherein the catheter is close to the urethral wall, the urethral wall is close to the prostate, and the ablative is transferred from the deployable component into the prostate tissue.

[0168] Figure 15E This specification illustrates one embodiment of the widening of the prostatic urethra after removal of the deployable catheter;

[0169] Figure 15F This specification illustrates a deployable component of a catheter in an deployed state according to some embodiments, and an exemplary use of one or more needles in ablative delivery, such as delivering steam or vapor through a hollow outlet on the edge of the needle;

[0170] Figure 15G This specification illustrates an embodiment of the use of an ablation catheter to ablate prostate tissue from a patient with median lobe hyperplasia via the transcystic duct approach;

[0171] Figure 15H This specification illustrates another embodiment of the use of an ablation catheter to ablate prostate tissue from a patient with median lobe hyperplasia via the transcystic duct approach;

[0172] Figure 15I This is a flowchart of a method for ablating prostate tissue in a patient with median lobe hyperplasia using an ablation catheter via the transcystic duct, as described in one embodiment of this specification, and lists the steps involved;

[0173] Figure 16A It is the International Prostate Symptom Score (IPSS) questionnaire;

[0174] Figure 16B It is the Benign Prostatic Hyperplasia Impact Index Questionnaire (BPHIIQ).

[0175] Figure 17A It shows the typical anatomical structure of the uterus and fallopian tubes in a human female;

[0176] Figure 17B It shows the location of the uterus and surrounding anatomical structures in a woman's body;

[0177] Figure 18A This specification shows exemplary ablation catheter arrangements for uterine ablation as described in some embodiments;

[0178] Figure 18B The settings described in some embodiments of this specification are shown. Figure 18A An exemplary embodiment of the groove in the internal conduit shown;

[0179] Figure 18C The usage described in the embodiments of this specification Figure 18A The flowchart shows a method for ablating endometrial tissue using a catheter.

[0180] Figure 18D The catheter for endometrial ablation described in other embodiments of this specification is shown;

[0181] Figure 18E This illustration shows the catheter described in an embodiment of the present specification entering the uterus via the cervical canal, with the distal positioning member in the deployed state;

[0182] Figure 18F This illustration shows the catheter, as described in the embodiments of this specification, further entering the uterus, with both the distal and proximal positioning components in an deployed state;

[0183] Figure 18G This specification illustrates that the steam described in the embodiments enters the uterus through multiple ports between the proximal and distal positioning components on the catheter body;

[0184] Figure 18H This is a flowchart illustrating the use of an ablation catheter to ablate the patient's endometrium as described in the embodiments of this specification, listing the steps involved;

[0185] Figure 18I These are side views, sectional side views, and distal end front views of the endometrial ablation catheter described in some embodiments of this specification.

[0186] Figure 18J The catheter described in some embodiments of this specification ( Figure 18I A perspective side view of a stent extending above the inner catheter and protruding from the outer catheter;

[0187] Figure 18K These are cross-sectional side views, perspective side views, and distal end front views of the braided support described in some embodiments of this specification;

[0188] Figure 18L This is a perspective side view of the distal end of the internal catheter as described in some embodiments of this specification;

[0189] Figure 18M This is a lateral anterior perspective view of the distal end of the internal catheter as described in some embodiments of this specification;

[0190] Figure 18N This is a top perspective view of the distal end of the internal catheter as described in some embodiments of this specification;

[0191] Figure 18O This is a different view of a dual-positioning member catheter with a non-invasive olive-shaped tip, as described in another embodiment of this specification;

[0192] Figure 18P The distal end of an ablation catheter having a distal positioning member and multiple ports along the catheter axis, as described in some embodiments of this specification, is shown.

[0193] Figure 18Q The distal end of an ablation catheter having a distal olive-shaped tip and a positioning member and having multiple ports along the length of the catheter axis, as described in some embodiments of this specification, is shown.

[0194] Figure 18R This is a distal end side view of an ablation catheter having a distal olive-shaped tip and two positioning members and multiple ports along the catheter axis as described in some embodiments of this specification.

[0195] Figure 18S yes Figure 18R Rear perspective view of the catheter shown;

[0196] Figure 18T This specification shows the distal end of an ablation catheter having a semi-circular opening at the distal end and a distal positioning member, as described in some embodiments of this specification.

[0197] Figure 18U The distal end of an ablation catheter having a spherical distal positioning member and a cover plate extending over all or part of the positioning member is shown in an exemplary embodiment of this specification.

[0198] Figure 18V The distal end of an ablation catheter having a spherical distal positioning member is shown in another exemplary embodiment of this specification;

[0199] Figure 18W This specification shows the distal end of an ablation catheter with a tapered distal positioning member, as described in yet another exemplary embodiment.

[0200] Figure 18XThis specification shows the non-invasive, soft tip of a catheter shaft for insertion into the cervix, as described in some embodiments.

[0201] Figure 19A This specification illustrates an embodiment of the method described above. Figure 18A The structure of the disc used in conjunction with the catheter arrangement shown;

[0202] Figure 19B This specification shows another embodiment of the same as described above. Figure 18A The structure of the disc used in conjunction with the catheter arrangement shown;

[0203] Figure 19C This specification shows yet another embodiment of the same as described above. Figure 18A The diagram shows various structures of the disc used in conjunction with the catheter arrangement;

[0204] Figure 19D This specification shows a catheter assembly with a handle and a cervical support as described in some embodiments;

[0205] Figure 19E This specification shows the position of the cervical pouch at the external os of the uterus and cervix before catheter deployment, as described in some embodiments of this specification.

[0206] Figure 19F This specification shows exemplary positions of the hand holding the catheter when deploying the proximal positioning component as described in some embodiments of this specification;

[0207] Figure 19G This specification shows, in some embodiments, the deployment of the proximal positioning component as the user pushes the catheter handle to extend the inner catheter into the uterus;

[0208] Figure 19H This specification illustrates the deployment of distal positioning components, which may be uncoated or selectively coated with silicone, according to some embodiments of the present specification.

[0209] Figure 19I This specification shows some embodiments of the operation of further retracting the first positioning member by rotating the turntable to partially seal the cervix, thereby isolating the uterus;

[0210] Figure 19J The distal end of an ablation catheter having two positioning members and multiple ports along the length of the catheter axis, as described in some embodiments of this specification, is shown.

[0211] Figure 19K The distal end of an ablation catheter having two positioning members and a distal olive-shaped tip, and having multiple ports along the catheter axis, as described in some embodiments of this specification, is shown.

[0212] Figure 19LThis specification shows a connector for connecting a distal positioning member to the distal end of an ablation catheter, as described in some embodiments.

[0213] Figure 19M This specification shows another connector for connecting the distal positioning member to the distal end of the ablation catheter, as described in other embodiments.

[0214] Figure 19N This specification shows connectors for connecting the proximal positioning member to the distal end of the ablation catheter, as described in some embodiments.

[0215] Figure 19O This specification shows another connector for connecting the proximal positioning member to the distal end of the ablation catheter, as described in other embodiments of this specification;

[0216] Figure 19P The axis of an ablation catheter with multiple ports as described in some embodiments of this specification is shown;

[0217] Figure 20A This specification illustrates an embodiment of endometrial ablation using an ablation device in a woman's uterus;

[0218] Figure 20B This specification shows a coaxial catheter for endometrial tissue ablation as described in one embodiment;

[0219] Figure 20C This is a flowchart of an embodiment of the present specification describing endometrial tissue ablation using a coaxial ablation catheter, listing the steps involved in the process;

[0220] Figure 20D This specification shows a bifurcated coaxial catheter for endometrial tissue ablation as described in one embodiment;

[0221] Figure 20E This is one embodiment of the use described in this specification. Figure 20D The flowchart shown illustrates the method of ablating endometrial tissue using an ablation catheter, outlining the steps involved.

[0222] Figure 20F This specification shows a bifurcated coaxial catheter with deployable components for endometrial tissue ablation according to one embodiment of the present specification.

[0223] Figure 20G Showing Figure 20F The catheter shown is inserted into the patient's uterine cavity to perform endometrial tissue ablation.

[0224] Figure 20H This is one example of the use described in this specification. Figure 20FThe flowchart shown illustrates the method of ablating endometrial tissue using an ablation catheter, outlining the steps involved.

[0225] Figure 20I This specification shows a bifurcated coaxial catheter for endometrial tissue ablation as described in another embodiment;

[0226] Figure 20J This specification shows a bifurcated coaxial catheter for endometrial tissue ablation, as described in yet another embodiment.

[0227] Figure 20K This specification shows a water-cooled catheter for endometrial tissue ablation as described in one embodiment;

[0228] Figure 20L This specification shows a water-cooled catheter for performing endometrial tissue ablation in a patient's uterus, as described in another embodiment.

[0229] Figure 20M This specification shows a water-cooled catheter for cervical ablation as described in one embodiment;

[0230] Figure 20N It shows the location of the patient's cervix Figure 20M The catheter shown;

[0231] Figure 200 Is using Figure 20M The flowchart shown illustrates the cervical ablation procedure using a catheter, outlining the steps involved.

[0232] Figure 21A This is a flowchart of an endometrial tissue ablation method according to one embodiment of this specification;

[0233] Figure 21B This is a flowchart of a uterine fibroid ablation method according to one embodiment of this specification;

[0234] Figure 22A This shows the different stages of bladder cancer known in the medical field;

[0235] Figure 22B This specification shows a system for bladder tissue ablation according to one embodiment;

[0236] Figure 23 Exemplary catheters for bladder tissue ablation as described in some embodiments of this specification are shown;

[0237] Figure 24A This is a front view of the positioning component described in some embodiments of this specification;

[0238] Figure 24B yes Figure 24ASide view of the distal end of the ablation catheter and the positioning component shown;

[0239] Figure 24C yes Figure 24B Anterior perspective view of the distal end of the ablation catheter and the positioning component shown;

[0240] Figure 25A This is a close-up view of the connection between the positioning component and the distal end of the ablation catheter as described in some embodiments of this specification;

[0241] Figure 25B Is with Figure 25A A side view of the positioning component connected to the distal end of the ablation catheter shown.

[0242] Figure 25C This specification illustrates different structural types of positioning components that can be used in various ablation catheters, as described in the embodiments of this specification.

[0243] Figure 26A The image shows the positioning of the needle ablation catheter described in the embodiments of this specification for selectively ablating the rich nerve layer of the deep detrusor muscle and the adventitia space below the trigone by delivering steam;

[0244] Figure 26B The image shows the positioning of the needle ablation device described in the embodiments of this specification for selectively ablating the bladder neck, internal urethral sphincter (IUS), and nerves of the IUS and bladder neck by delivering steam;

[0245] Figure 27A These are different views of the coaxial needles that can be used for OAB ablation therapy as described in some embodiments of this specification;

[0246] Figure 27B The distal end of a coaxial needle comprising an inner tube and an outer tube (having a lumen) as described in some embodiments of this specification is shown;

[0247] Figure 28 This is a flowchart illustrating an exemplary ablation process of the bladder and / or its surrounding area as described in some embodiments of this specification;

[0248] Figure 29 This specification illustrates a system for prostate tissue ablation and imaging according to one embodiment;

[0249] Figure 30 This specification shows a system for endometrial tissue ablation and imaging according to one embodiment;

[0250] Figure 31 This specification illustrates a system for bladder tissue ablation and imaging according to one embodiment;

[0251] Figure 32The various components of the optical / observation system for direct ablation visualization described in the embodiments of this specification are shown;

[0252] Figure 33 The image shows a component of the distal end of an ablation system described in embodiments of this specification for the treatment of benign prostatic hyperplasia (BPH) and abnormal uterine bleeding (AUB);

[0253] Figure 34 These are images of the distal end of the ablation catheter observed on a display device, as described in some embodiments of this specification.

[0254] Figure 35A This is a cross-sectional view of one embodiment of the combined catheter (including a lumen for an optical / electrical catheter and a lumen for an ablation catheter) described in some embodiments of this specification;

[0255] Figure 35B This is a cross-sectional view of another embodiment of the combined catheter (including a lumen for an optical / electrical catheter and a lumen for an ablation catheter) described in some embodiments of this specification;

[0256] Figure 35C This is a cross-sectional view of yet another embodiment of the combined catheter (including a lumen for an optical / electrical catheter and a lumen for an ablation catheter) described in some embodiments of this specification. Detailed Implementation

[0257] In various embodiments, the ablation device and catheter described herein are used in conjunction with any one or more heating systems described in U.S. Patent Application No. 14 / 594,444, filed January 12, 2015, entitled “Method and Apparatus for Tissue Ablation” (published February 7, 2017, as U.S. Patent No. 9,561,068, the entire contents of which are incorporated herein by reference in their entirety). The entire contents of the following U.S. patent applications are incorporated herein by reference in their entirety: U.S. Patent Application No. 15 / 600,670, filed May 19, 2017, entitled “Ablation Catheter with Integrated Cooling Function”; U.S. Patent Application No. 15 / 144,768, filed May 2, 2016, entitled “Induction-Based Micro-Heating System” (published September 4, 2018, as U.S. Patent No. 10,064,697); and U.S. Patent Application No. 14 / 594,444, filed January 17, 2014, entitled “Ablation Method and Apparatus”. U.S. Patent Application No. 158,687, “Method and Apparatus for Tissue Ablation,” was published on February 7, 2017, as U.S. Patent No. 9,561,067; U.S. Patent Application No. 13 / 486,980, filed on June 1, 2012, “Method and Apparatus for Tissue Ablation,” was published on February 7, 2017, as U.S. Patent No. 9,561,066; and U.S. Patent Application No. 12 / 573,939, filed on October 6, 2009, “Method and Apparatus for Tissue Ablation.”

[0258] "Treatment" and its variations refer to reducing the degree, frequency, or severity of one or more symptoms or signs associated with a condition.

[0259] A “course of treatment” and its variations refer to the specified duration of treatment from start to finish (whether treatment ends due to symptom relief or is suspended for any reason). Multiple treatment periods may be specified within a course of treatment, during which one or more specified stimuli are administered to the subject.

[0260] "Cycle" refers to the time it takes to administer "one dose" of stimulant to a subject according to a specified treatment plan.

[0261] The term "and / or" refers to one or all of the listed elements, or any combination of two or more listed elements.

[0262] In the specification and claims of this application, each word and its form in “comprise,” “include,” and “have” is not necessarily limited to the items in the list associated with these words. The term “comprise” and its variations are not intended to be limiting in the specification and claims.

[0263] Unless otherwise stated, “a”, “an”, “the”, “one or more” and “at least one” are used interchangeably to mean one or more.

[0264] The term "controller" refers to an integrated hardware and software system defined by multiple processing elements (e.g., integrated circuits, application-specific integrated circuits, and / or field-programmable gate arrays) that communicate with memory elements (e.g., random access memory or read-only memory), wherein one or more processing elements can execute program instructions stored in one or more memory elements.

[0265] The term "steam generating system" refers to any or all methods of generating steam using water as described in this application, based on heaters or induction.

[0266] The embodiments described in this specification can be used to treat urogenital structures, wherein the term "urogenital" includes all reproductive and urinary structures, including but not limited to the prostate, uterus, and bladder, and any conditions associated with them, including but not limited to benign prostatic hyperplasia (BPH), prostate cancer, uterine fibroids, abnormal uterine bleeding (AUB), overactive bladder (OAB), strictures, and tumors.

[0267] Any and all needles and needle structures disclosed in the specification for a particular embodiment (e.g., including but not limited to single needles, double needles, multi-needles, and heat-insulating needles) are not limited to this embodiment and may be combined with any other embodiment disclosed in the specification for the treatment of any condition related to that organ system in any organ system, such as, but not limited to, prostate, uterus, and bladder ablation.

[0268] In this specification, "complete ablation" means ablation of more than 55% of the surface area or volume surrounding the anatomical structure.

[0269] All methods and systems used to treat the prostate, uterus, and bladder may include optics or visualization features, as described in the specification, that facilitate direct visualization during ablation.

[0270] In some embodiments, all ablation catheters disclosed in the specification have a heat insulation layer at the electrode location to prevent ablation of tissue near the electrode location inside the catheter.

[0271] For any method disclosed herein that includes discrete steps, these steps may be performed in any feasible order, and any combination of two or more steps may be performed simultaneously as appropriate.

[0272] Furthermore, in this document, numerical ranges described by endpoints include all numbers within that range (e.g., "1-5" includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc.). It should be understood that, unless otherwise stated, all figures used in the specification and claims representing parameters such as the number of parts, molecular weight, etc., are modified in all cases by the term "about". Therefore, unless otherwise stated to the contrary, the numerical parameters given in the specification and claims are approximate values ​​and may vary depending on the desired characteristics sought to be obtained in this specification. Each numerical parameter should be interpreted, at least according to the number of significant digits reported, using conventional rounding methods, rather than attempting to limit the doctrine of equivalence to the scope of the claims.

[0273] The numerical ranges and parameters are approximate, indicating that the specification has a wide range, but the values ​​described in the specific embodiments are as accurate as possible. However, all values ​​themselves include a range defined by the standard deviation of their respective test measurements.

[0274] The devices and methods described in this specification can be used to focally or circumferentially ablate target tissue to different depths under controlled conditions, achieving complete healing through re-epithelialization. Furthermore, vapor can be used to treat / ablate benign and malignant tissue growths, thereby destroying, liquefying, and absorbing the ablated tissue. The dosage and manner of treatment can be adjusted according to the type of tissue and the required ablation depth. Ablation devices can be used for prostate and endometrial ablation to treat any mucosal, submucosal, or circumferential lesions, such as inflammatory lesions, tumors, polyps, and vascular lesions. Ablation devices can also be used for bladder ablation to treat overactive bladder (OAB). Ablation devices can also be used to treat focal or circumferential mucosal or submucosal lesions of the urogenital tract. Ablation devices can be placed endoscopically, radiologically, surgically, or with direct visualization capabilities. In various embodiments, a wireless endoscope or a single-fiber endoscope may be included as part of the device. In another embodiment, magnetic or stereotactic navigation can be used to guide the catheter to the desired location. Radiographic positioning can be achieved using radiopaque or acoustically transparent materials within the catheter body. Ferromagnetic materials that facilitate magnetic navigation can be used in the conduit.

[0275] Ablation agents such as steam, heated gases, or refrigerants (e.g., but not limited to liquid nitrogen) are inexpensive and readily available. They can flow onto the tissue through infusion ports, maintaining a fixed and consistent distance for ablation. This ensures uniform distribution of the ablation agent across the target tissue. A microprocessor controls the flow of the ablation agent using a predetermined method based on the characteristics of the tissue to be ablated, the required ablation depth, and the distance between the port and the tissue. The microprocessor can utilize temperature, pressure, or other sensor data to control the flow of the ablation agent. Furthermore, the ablation agent can be aspirated from the vicinity of the target tissue through one or more aspiration ports. When treating the target segment, the ablation agent can be continuously infused, or the microprocessor can determine and control the ablation agent infusion and removal cycles.

[0276] It should be understood that the apparatus and embodiments described herein are implemented in conjunction with a controller (including a microprocessor that executes control instructions). The controller can be any computing device, including desktop computers, laptops, and mobile devices, and can transmit control signals to the ablation device in a wired or wireless manner.

[0277] This invention relates to several embodiments. The following disclosure is intended to enable those skilled in the art to practice the invention. The language used in this specification should not be construed as a general denial of any particular embodiment or as limiting the meaning of the claims beyond the terms used herein. The general principles described herein can be applied in other embodiments and applications without departing from the spirit and scope of the invention. Furthermore, the terms and phrases used are for illustrative purposes only and should not be considered limiting. Therefore, the invention should be considered to have the broadest scope, including numerous alternatives, modifications, and equivalents that conform to the disclosed principles and features. For clarity, details of technical materials known in the relevant art are not described herein to avoid unnecessarily obscuring the invention.

[0278] It should be noted that, unless otherwise expressly stated, any feature or component described herein in conjunction with specific embodiments may be used and implemented in conjunction with any other embodiment.

[0279] Figure 1AAn ablation system 100 according to an embodiment of this specification is shown. The ablation system includes a catheter 10 having at least one first distal connection or positioning member 11 and an internal heating chamber 18 disposed within the lumen of the catheter 10, capable of heating a liquid supplied to the catheter 10 to transform the liquid into ablation vapor. The internal heating chamber 18 includes an electrode or an electrode array, the electrode being separated from the heat-conducting member by a section of non-conductive catheter 10. In some embodiments, the catheter 10 is made of or covered with an insulating material to prevent ablation energy from escaping from the catheter body. The catheter 10 includes one or more infusion ports 12 for infusion of an ablation agent (such as vapor). In some embodiments, the one or more infusion ports 12 include a single infusion port located distal to the needle. In some embodiments, the catheter includes a second positioning member 13 adjacent to the infusion port 12. In various embodiments, the first distal connection or positioning member 11 and the second positioning member 13 can be any of a disc, cover, cap, or inflatable balloon. In some embodiments, the distal connection or positioning member has a wire mesh structure (with or without a covering membrane). In some embodiments, the first distal connection or positioning member 11 and the second positioning member 13 include orifices 19 for air or ablative escape. A liquid such as saline is stored in a reservoir (e.g., a saline pump 14), which is connected to the catheter 10. The delivery of the ablative is controlled by a controller 15, and the treatment is controlled by the treating physician via the controller 15. The controller 15 includes at least one processor 23 for data communication with the saline pump 14, and a catheter connection port 21 in fluid communication with the saline pump 14. In some embodiments, at least one optional sensor 17 is used to monitor changes in the ablation area for ablative delivery. In some embodiments, the optional sensor 17 includes at least one of a temperature sensor or a pressure sensor. In some embodiments, the catheter 10 includes a microporous filter 16 that provides back pressure for the delivery of vapor, thereby pressurizing the vapor. The predetermined size of the filter micropores determines the back pressure, and thus the temperature of the generated vapor. In some embodiments, the system further includes a foot pedal 25 (for data communication with the controller 15), a switch 27 (located on the conduit 10), or a switch 29 (located on the controller 15) for controlling the steam flow rate. In various embodiments, the switch 29 is located on the generator or conduit handle.

[0280] In one embodiment, the controller 15 includes a user interface that allows physicians to define devices, organs, and conditions, and to create default settings for temperature, circulation, volume (sound), and standard RF settings. In one embodiment, the physician can further modify these default values. The user interface also includes a standard display of all key variables and warnings (if values ​​exceed or fall below certain levels).

[0281] The ablation device also includes safety mechanisms to prevent burns to the user when operating the catheter (including insulation, optionally, cold air rinsing, cold water flushing, and alarm / bell sounds to indicate treatment initiation and cessation).

[0282] Figure 1B This is a transverse cross-sectional view 121 of a flexible heating chamber 130 according to an embodiment of this specification. The flexible heating chamber 130 can be installed on the distal part or distal tip of the conduit, or can be integrally formed with the distal part or distal tip of the conduit. Figure 1C The diagram shows a transverse sectional view 122a and a longitudinal sectional view 122b of a first electrode array 136 of a flexible heating chamber for a conduit according to an embodiment of this specification, and a transverse sectional view 123a and a longitudinal sectional view 123b of a second electrode array 138. Figure 1D and 1E The images show transverse and longitudinal sectional views 124 and 125 of the heating chamber 130 (including assembled first and second electrodes 136 and 138).

[0283] Now refer to Figure 1B , 1C In embodiments 1D and 1E, the heating chamber 130 includes an outer covering 132 and a coaxial inner core, channel, or cavity 134. A plurality of electrodes are disposed between the outer covering 132 and the inner cavity 134, the plurality of electrodes being configured as first and second electrode arrays 136, 138. In some embodiments, the first and second electrode arrays 136, 138 respectively include metal rings 142, 144, and a plurality of electrode fins or members 136', 138' extending radially from the metal rings 142, 144 into the space between the outer covering 132 and the insulating inner core / cavity 134 (see 122a, 123a). The electrode fins or members 136', 138' also extend longitudinally along the longitudinal axis 150 of the heating chamber 130 (see 122b, 123b). In other words, each electrode fin 136', 138' has a first dimension along the radius of the heating chamber 130 and a second dimension along the longitudinal axis 150 of the heating chamber 130. Electrode fins or components 136', 138' define multiple segmented spaces 140 between them through which saline / water flows and evaporates into steam. Current is introduced from a controller into a conduit, then through a lumen to the electrodes 136, 138, causing the fins or components 136', 138' to generate an electric charge, which is then conducted through the saline to heat the saline, converting it into steam. The first and second dimensions increase the surface area of ​​the electrodes 136, 138 for heating the saline / water flowing within the spaces 140. In the embodiment, the first electrode 136 has a first polarity, and the second electrode 138 has a second polarity opposite to the first polarity. In this embodiment, the first polarity is negative (cathode), and the second polarity is positive (anode).

[0284] In this embodiment, the outer covering 132 and the inner core / lumen 134 are composed of silicone, polytetrafluoroethylene, ceramic, or any other suitable thermoplastic / electrically insulating elastomer known to those skilled in the art. The inner core / lumen 134, the outer covering 132, and the electrodes 136, 138 (including rings 142, 144 and fins or members 136', 138') are all flexible structures, allowing the distal portion or tip of the catheter to bend for better catheter positioning during ablation. In this embodiment, the inner core / lumen 134 stabilizes the electrodes 136, 138 and maintains separation or a gap 140 between them, while the catheter tip bends or flexes during use to prevent physical contact and short circuits between the electrodes.

[0285] like Figure 1D and 1E As shown, during the assembly of the heating chamber 130, the electrode fins or components 136' and 138' interlock or cross each other (similar to the fingers of two hands clasped together). An anode component follows a cathode component, which in turn follows a cathode component, and so on, with each cathode and anode component separated by a space 140. In various embodiments, the distance from the cathode component to the anode component in each space 140 ranges from 0.01 mm to 2 mm. In some embodiments, the first electrode array 136 comprises 1-50 electrode fins 136', preferably 4 electrode fins 136', while the second electrode array 138 comprises 1-50 electrode fins 138', preferably 4 electrode fins 138'. In various embodiments, the width w of the heating chamber 130 is in the range of 1-5 mm, and the length l is in the range of 5-500 mm.

[0286] According to one aspect of this specification, multiple heating chambers 130 may be provided inside the tip of the catheter. Figure 1F and 1G This is a longitudinal sectional view 130 of the catheter tip 155 described in the embodiments of this specification, wherein two heating chambers 130 are arranged in series. (See reference) Figure 1F and 1G Two heating chambers 130 are arranged in series, with the space 160 between them acting as a hinge, increasing the flexibility of the conduit tip 155 and allowing it to bend. Each of the two heating chambers 130 includes intersecting first and second electrode arrays 136 and 138. Using multiple (e.g., two or more) heating chambers 130 can further increase the surface area of ​​the electrodes 136 and 138 while maintaining the flexibility of the conduit tip 155.

[0287] Now for reference Figures 1B to 1GWhen steam is generated, fluid is transferred from the reservoir (such as a syringe) to the heating chamber 130 via a pump or other pressurization method. In this embodiment, the fluid is sterile saline or water, and is transferred at a constant or variable flow rate. An RF generator is connected to the heating chamber 130 and powers the first and second electrode arrays 136, 138. Figure 1E As shown, during steam generation, as fluid flows through space 140 within heating chamber 130, electrodes 136 and 138 are energized, charging the electrodes with saline solution. This saline solution is then heated resistively, causing the water in the saline solution to evaporate. In other embodiments, conduction heating, convection heating, microwave heating, or induction heating are used to convert saline solution into steam. Fluid preheating occurs in the first proximal zone 170 of heating chamber 130. When the fluid is heated to a sufficient temperature (e.g., 100°C at atmospheric pressure), the fluid begins to transform into steam or vapor in the second intermediate zone 175. When the fluid reaches the third distal zone 180, the fluid is completely converted into steam, after which the fluid can exit the distal end 133 of heating chamber 130 and exit the conduit tip 155. If the pressure inside the heating chamber is greater than atmospheric pressure, the temperature needs to be increased; if the pressure inside the heating chamber is lower than atmospheric pressure, steam will be generated at a lower temperature. When no saline solution flows through the heating chamber, the current through the heating chamber is interrupted (dry electrode), and no heat is generated. Electrode impedance measurement can be used to measure the flow rate of physiological saline and dry / wet electrodes.

[0288] In one embodiment, a sensor probe may be positioned at the distal end of the intracatheter heating chamber. During vaporization, the sensor probe sends a signal to a controller. The controller can use this signal to determine whether the fluid has completely vaporized before leaving the distal end of the heating chamber. Sensing whether saline solution has completely vaporized is particularly useful in many surgical applications; for example, in the ablation of various tissues, delivering high-quality (low water content) vapor can make the treatment more effective. In some embodiments, the heating chamber includes at least one sensor 137. In various embodiments, the at least one sensor 137 includes an impedance, temperature, pressure, or flow sensor, with a pressure sensor being a secondary preferred sensor. In one embodiment, the impedance of the electrode arrays 136, 138 may be sensed. In other embodiments, the temperature of the fluid, the temperature of the electrode array, the fluid flow rate, pressure, or similar parameters may be sensed.

[0289] Figure 1H and Figure 1IMulti-lumen balloon catheters 161 and 171, as described in embodiments of this specification, are shown respectively. Catheters 161 and 171 each include an elongated body 162 and 172 (having a proximal end and a distal end). Catheters 161 and 171 include at least one positioning member (proximately to their distal end). In various embodiments, the positioning member is a balloon. In some embodiments, the catheter includes multiple positioning members.

[0290] exist Figure 1H and 1I In the illustrated embodiment, catheters 161 and 171 each include a proximal balloon 166 and 176 and a distal balloon 168 and 178 (near the distal end of the elongation body 162 and 172), respectively. Multiple infusion ports 167 and 177 are provided on the elongation body 162 and 172 between the two balloons 166 and 176 and 168 and 178. The elongation body 162 and 172 also include at least one heating chamber 130, which is located close to and directly adjacent to the proximal balloons 166 and 176. Figure 1H The embodiment shows a heating chamber contained within the elongated body 165 (near and just adjacent to the proximal balloon 166). In some embodiments, multiple heating chambers are arranged in series within the catheter body.

[0291] exist Figure 1I In one embodiment, two heating chambers 130 are disposed within the elongated body 172, close to and just adjacent to the proximal balloon 176. (See reference...) Figure 1I To inflate balloons 176 and 178 and supply current and fluid to catheter 171, a fluid pump 179, an air pump 173, and a radiofrequency generator 184 are coupled to the proximal end of the elongation body 172. The air pump 173 pumps air through a first port into a first lumen (extending along the length of the elongation body 172) to inflate balloons 176 and 178, holding catheter 171 in place for ablation treatment. In another embodiment, catheter 171 includes an additional air port and an additional air lumen, allowing balloons 176 and 178 to be inflated individually. The fluid pump 179 pumps fluid through a second lumen (extending along the length of the elongation body 172) to the heating chamber 130. The radiofrequency generator 184 supplies current and fluid to electrodes 136 and 138 (… Figure 1G , 1H An electric current is supplied to the electrodes 136 and 138, causing them to generate heat and thus converting the fluid flowing through the heating chamber 130 into vapor. The generated vapor flows through the second lumen and exits through the port 177. The flexible heating chamber 130 improves the flexibility and maneuverability of the catheters 161 and 171, allowing physicians to better position the catheters 161 and 171 when performing ablation procedures, such as ablation of Barrett's esophagus tissue in a patient's esophagus.

[0292] Figure 1JA catheter 191 with proximal and distal positioning members 196, 198 and an electrode heating chamber 130, as described in embodiments of this specification, is shown. The catheter 191 includes an elongated body 192 having a proximal end and a distal end. The catheter 191 includes a proximal positioning member 196 and a distal positioning member 198, the distal positioning member 198 being located near the distal end of the elongated body 192. Between the two positioning members 196, 198, the elongated body 192 has a plurality of infusion ports 197. The elongated body 192 also includes at least one heating chamber 130 located within a central lumen. In some embodiments, the proximal positioning member 196 and the distal positioning member 198 include a compressible disc that expands upon deployment. In some embodiments, the proximal positioning member 196 and the distal positioning member 198 are made of shape memory metal and are convertible from a first compressed configuration (for delivery through an endoscopic lumen) and a second expanded configuration (for treatment). In one embodiment, the disc includes a plurality of orifices 199 to allow air to escape at the start of the ablation procedure, and to escape once the pressure and / or temperature within the closed treatment zone created between the two positioning members 196, 198 reaches a predefined limit, as described above. In some embodiments, the conduit 191 includes a filter 193 with micropores that provides back pressure to the delivered vapor, thereby pressurizing the vapor. The micropores of a predetermined size on the filter determine the back pressure and temperature of the generated vapor.

[0293] It should be understood that the filter 193 can take any structure, allowing vapor to exit the port and restricting vapor flow back into the catheter or upstream within the catheter. Preferably, the filter has a thin, porous metal or plastic structure located within the catheter lumen and near one or more ports. Alternatively, a one-way valve can be used, which allows vapor to exit from the port but prevents it from flowing back into the catheter. In one embodiment, structure 193 can be a filter, a valve, or a porous structure, and is located within 5 cm of the port, preferably within 0.1 cm to 5 cm of the port, more preferably within less than 1 cm of the port, which refers to the actual opening through which vapor can exit the catheter and enter the patient's body.

[0294] Figure 1KAn ablation system 101 for prostate tissue ablation as described in some embodiments of this specification is shown. The ablation system 101 includes a catheter 102 having an internal heating chamber 103 disposed within the lumen of the catheter 102 and capable of heating fluid supplied to the catheter 102, converting the fluid into ablation vapor. In one embodiment, the fluid is conductive saline solution, which can be converted into non-conductive or poorly conductive vapor. In one embodiment, by comparing the conductivity of the fluid (e.g., saline solution) before passing through the heating chamber with the conductivity of the ablation agent (e.g., vapor) after passing through the heating chamber, it can be determined that the conductivity of the fluid is reduced by at least 25%, preferably 50%, and more preferably 90%. It should also be understood that, for each embodiment disclosed in this specification, the term ablation agent preferably refers only to heated vapor or steam and the inherent thermal energy stored therein, without enhancement from any other energy source (including radio frequency, electrical, ultrasound, optical, or other forms of energy).

[0295] In some embodiments, the conduit 102 is made of or covered with an insulating material to prevent ablation energy from escaping from the conduit body. A plurality of openings 104 are provided near the distal end of the conduit 102, allowing a plurality of associated thermally conductive elements (such as needles 105) to extend (at an angle to the conduit 102, wherein the angle ranges from 30° to 90°) and expand or contract through the plurality of openings 104. According to one aspect, the plurality of retractable needles 105 have a hollow structure and include at least one infusion port 106 through which an ablation agent (e.g., vapor or steam) can be delivered when the needle 105 extends and expands through the plurality of openings 104 on the extended body of the conduit 102. In some embodiments, the infusion port is positioned along the length of the needle 105. In some embodiments, the infusion port 106 is located at the distal end of the needle 105. During use, a coolant (such as water, air, or CO2) circulates through an optional port 107 to cool the conduit 102. Ablation vapor and cooling coolant are supplied to the proximal end of the conduit 102. Fluids such as saline are stored in a reservoir such as a saline pump 14 connected to catheter 102. The delivery of the ablation agent is controlled by a controller 15, and the treatment is controlled by the treating physician via the controller 15. The controller 15 includes at least one processor 23 (in data communication with the saline pump 14) and a catheter connection port 21 (in fluid communication with the saline pump 14). In some embodiments, at least one optional sensor 22 monitors changes within the ablation zone to guide the ablation agent flow. In some embodiments, the optional sensor includes at least one of a temperature sensor or a pressure sensor. In some embodiments, catheter 102 includes a filter 16 with micropores that provides back pressure to the delivered vapor, thereby pressurizing the vapor. The micropores of a predetermined size on the filter determine the back pressure and temperature at which the vapor is generated. In some embodiments, the system further includes a foot pedal 25 (in data communication with the controller 15), a switch 27 (located on catheter 102), or a switch 29 (located on controller 15) for controlling the vapor flow rate. In some embodiments, the needle has a connecting mechanism that changes the needle's orientation from being relatively parallel to the catheter to having an angle between 30° and 90° with the catheter. In one embodiment, the mechanism is a drawstring. In some embodiments, the opening on the catheter is shaped to change the needle's orientation from being relatively parallel to the catheter to having an angle between 30° and 90° with the catheter.

[0296] In one embodiment, the user interface included in the microprocessor 15 allows physicians to define devices, organs, and conditions, and to create default settings for temperature, circulation, volume (sound), and standard RF settings. In one embodiment, the physician can further modify these default values. The user interface also includes a standard display of all key variables and warnings (if values ​​exceed or fall below certain levels).

[0297] The ablation device also includes safety mechanisms to prevent burns to the user when operating the catheter (including insulation, optionally, cold air rinsing, cold water flushing, and alarm / bell sounds to indicate treatment initiation and cessation).

[0298] Figure 1L This specification shows some embodiments described. Figure 1K Another view of the conduit 102 shown. The conduit 102 includes an elongation 108 having a proximal end and a distal end. A plurality of openings 104 are provided near the distal end of the conduit 102, allowing a plurality of associated heat-conducting components (such as needles 105) to extend (at an angle to the conduit 102, wherein the angle ranges from 10° to 90°) and expand or contract through the plurality of openings 104. According to one aspect, the plurality of retractable needles 105 have a hollow structure and include at least one infusion port 106 through which an ablative agent (e.g., vapor or steam) can be delivered when the needle 105 extends and expands through the plurality of openings 104 on the elongation of the conduit 102. In some embodiments, the infusion port is positioned along the length of the needle 105. In some embodiments, the infusion port 106 is located at the distal end of the needle 105. Optionally, during use, a coolant (such as water, air, or CO2) is circulated through an optional port 107 to cool the conduit 102. The body 108 includes at least one heating chamber 103, both near and proximal to an optional port 107 or opening 104. In an embodiment, the heating chamber 103 includes two electrodes 109 that can receive radio frequency current to heat and convert a supplied fluid (e.g., saline) into vapor or steam for ablation.

[0299] refer to Figure 1L To supply current, ablation fluid, and optional coolant to catheter 102, a radiofrequency generator 184, a first fluid pump 174, and a second fluid pump 185 are coupled to the proximal end of the elongation body 108. The first fluid pump 174 pumps a first fluid (e.g., saline) to heating chamber 103 through a first lumen (extending along the length of elongation body 108). The radiofrequency generator 184 supplies current to electrode 109, causing electrode 109 to generate heat, thereby converting the fluid flowing through heating chamber 130 into vapor. The generated vapor flows through the first lumen, opening 104, needle 105, and exits at infusion port 106 to ablate prostate tissue. Optionally, in some embodiments, the second fluid pump 185 pumps a second fluid (e.g., water) to optional port 107 through a second lumen (extending along the length of elongation body 108), at which port 107 the second fluid exits catheter 102, circulates within the ablation zone, and cools the ablation zone. The flexible heating chamber 103 improves the flexibility and operability of the catheter 102, allowing physicians to better position the catheter 102 when performing ablation procedures, such as ablation of a patient's prostate tissue.

[0300] Figure 1M A system 100m for prostate tissue ablation, according to another embodiment of this specification, is shown. System 100m includes a catheter 101m, which in some embodiments includes a handle 190m having actuators 191m and 192m for extending at least one needle 105m or more needles from the distal end of the catheter 101m and for expanding a positioning member 11m at the distal end of the catheter 101m. In some embodiments, actuators 191m and 192m may be a knob or slider or any other type of switch or button, enabling the extension of at least one needle 105m or more needles. Vapor delivery through the catheter 101m is controlled by a controller 15m. In an embodiment, the catheter 101m includes an outer sheath 109m and an inner catheter 107m. The needle 105m extends from the inner catheter 107m at the distal end of the sheath 109m, or in some embodiments through an opening near the distal end of the sheath 109m. In an embodiment, the positioning member 11m is an expandable member located at the distal end of the inner catheter 107m and compressible within the outer sheath 109m for transmission. In some embodiments, the actuator 191m includes a knob that, when rotated within a first range (e.g., a quarter turn), pulls the outer sheath 109m back. When the outer sheath 109m retracts, the positioning member 11m is exposed. In an embodiment, the positioning member 11m includes a disc or cone configured as a bladder anchor. In an embodiment, rotating the actuator / knob within a second range, e.g., a second quarter turn, further pulls the outer sheath 109m back to deploy the needle 105m. In some embodiments, the number of deployed needles is two or more. In some embodiments, reference is also made to... Figure 1M , 4C In embodiments 4E, needles 105m and 3116a extend from the inner lumen of the inner catheter 107m and 3111a through a groove or opening 3115a on the outer sheath 109m and 3110a, facilitating needle path control and isolating the urethra from vapor. In some embodiments, the opening is covered with a slit cap 3119. For example, in another embodiment, as... Figure 4D As shown, when the outer sheath 3110b is pulled back, the sleeve 3116b naturally bends outward.

[0301] Refer again Figure 1MIn some embodiments, the catheter 101m includes a fluid delivery port 103m (e.g., for delivering coolant during ablation). In some embodiments, port 103m may also facilitate fluid collection, provide a vacuum, and provide CO2 for integrity testing. In some embodiments, port 103m is located on handle 190m. In some embodiments, at least one electrode 113m is provided at the distal end of catheter 101m near needle 105m. Electrode 113m may receive current supplied by connection line 111m (extending from controller 15m to catheter 101m) to heat and convert fluid, such as saline solution supplied via conduit 112m (extending from controller 15m to catheter 101m). The heated fluid or saline solution is converted into vapor or steam, which is then delivered by needle 105m for ablation.

[0302] Figure 1R A system 100r for prostate tissue ablation, according to another embodiment of this specification, is shown. System 100r includes a catheter 101r. In some embodiments, catheter 101r includes a handle 190r, which includes actuators 191r and 192r for extending at least one needle 105r or more needles from the distal end of catheter 101r. A drive mechanism disposed within handle 190r is deployed inside and outside the tip of catheter shaft 101r and retracts the needle 105r. In some embodiments, actuators 191r and 192r are knobs, sliders, or any other type of switch or button that extend at least one needle 105r or more needles. In some embodiments, actuator 191r is a button or switch that allows a physician to activate treatment using system 100r (not shown) via handle 190r and a foot pedal. In some embodiments, a strain relief mechanism 110r is disposed at the distal end of handle 190r for connecting handle 190r to catheter 101r. The strain relief mechanism 110r provides support for the conduit shaft 101r. Vapor delivery through the conduit 101r is controlled by the controller 15r. In the handle 190r, a cable sub-assembly 123r (including a power cable) connects the conduit 101r to the controller 15r. In this embodiment, the conduit 101r includes an outer sheath 109r and an inner conduit (not shown).

[0303] In various embodiments, the controller 15r of the system described in this specification (in) Figure 1A , Figure 1K , Figure 1N , Figure 1M , Figure 1P , Figure 1Q and Figure 22BThe following are examples of computing devices (15, 15m, 15p, 15q, and 2252, respectively): The computing device includes one or more processors or central processing units (CPUs), one or more computer-readable storage media (such as RAM, hard disks, or any other optical or magnetic media), a controller (such as an input / output controller), at least one communication interface, and a system memory. The system memory includes at least one random access memory (RAM) and at least one read-only memory (ROM). In embodiments, the memory includes a database for storing raw data, images, and data related to these images. Multiple functional and arithmetic elements communicate with the CPU to enable the computing device to operate. In various embodiments, the computing device may be a conventional standalone computer, or alternatively, the functionality of the computing device may be distributed across a network of multiple computer systems and architectures and / or cloud computing systems. In some embodiments, multiple program instructions or code sequences stored in one or more non-volatile memories are executed, enabling the CPU of the computing device to perform various functions and the processing described herein. In alternative embodiments, hard-wired circuitry may be used in place of or in conjunction with software instructions to implement the system and method processes described herein. Therefore, the system and method are not limited to a specific combination of hardware and software.

[0304] The needle tip assembly 125r is placed within the needle chamber 108r inside the outer sheath 109r. The needle chamber 108r, which can be a metal or plastic sleeve, accommodates the needle 105r during delivery to assist in needle deployment and retraction, see reference. Figure 1T Further explanation is provided. When the needle tip assembly 125r (including the needle 105r) is pushed out from the needle chamber 108r at the distal end of the sheath 109r, or in some cases, pushed past an opening near the distal end of the sheath 109r, the needle tip assembly 125r extends from the inner cannula. In embodiments, a positioning member is also provided at the distal end of the inner cannula. This positioning member is deployable and compressible within the outer sheath 109r for delivery. In some embodiments, the actuator 192r includes a knob that, when rotated to a first degree (e.g., a quarter turn), pulls back the outer sheath 109r. The positioning member is exposed when the outer sheath 109r is retracted. In embodiments, rotating the actuator / knob 192r to a second degree (e.g., a second quarter turn) pulls back the outer sheath 109r to further deploy the needle 105r. In some embodiments, the number of deployed needles is two or more. In some embodiments, reference is also made to… Figure 1R , Figure 4C and Figure 4EThe needles 105r and 3116a are deployed outside the lumen of the inner catheter 3111a through slots or openings 3115a in the outer sheaths 109r and 3110a. This helps control the needle path and isolates the urethra from vapor. In some embodiments, the opening is covered with a slit cap 3119. For example, in another embodiment, as... Figure 4D As shown, when the outer sheath 3110b is pulled back, the sleeve 3116b naturally folds outward.

[0305] Figure 1R This is a developed view of the needle tip assembly 125r, which includes a needle 105r connected to a needle connection member 107r. In some embodiments, the needle connection member 107r includes a threaded metal connector. (See reference...) Figure 1S Further detailed description is provided. A needle connection component or threaded connector 107r connects the needle 105r to the conduit 101r. In embodiments, the needle connection component 107r includes a threaded surface that is securely connected to the tip of the conduit 101r and screws the needle 105r onto it. In some embodiments, the needle 105r is a 22 to 25 G needle. In some embodiments, the needle 105r has a gradient coating to provide thermal insulation or echo reflectivity. The thermal insulation coating 106r may be ceramic, polymer, or any other material suitable for coating the needle 105r and providing thermal insulation and / or echo reflectivity to the needle 105r. The coating is located at various lengths from the needle tip at the needle seat of the needle 105r.

[0306] Similarly, refer to Figure 1R In some embodiments, catheter 101r includes a tube and a connector subassembly (port) 103r for delivering fluid, such as a cooling fluid, during ablation. In some embodiments, port 103r may also be used to collect fluid, provide a vacuum, and provide CO2 for integrity testing. In some embodiments, port 103r is located on handle 190r. In some embodiments, one or more electrodes 113r are placed proximal to the distal end of catheter 101r by one or more needles 105r. The one or more electrodes 113r may receive current supplied by connection line 111r (from controller 15r to catheter 101r) to heat and convert fluid, such as saline, supplied through tube 112r (from controller 15r to catheter 101r). The heated fluid or saline is converted into vapor or steam, which is delivered by needle 105r for ablation.

[0307] Figure 1SThe diagram illustrates a needle connection component 107s of a system 100s for prostate tissue ablation as described in some embodiments of this specification. In a preferred embodiment, the needle connection component 107s (including a lumen 117s defining an inner cavity) is fixedly connected to the end of an inner catheter 119s, such that the lumen 129s of the inner catheter 119s is in fluid communication with the lumen 117s of the needle connection component 107s. Preferably, the distal outer surface 127s of the needle connection component 107s has a plurality of threads onto which a needle 105s can be screwed. Furthermore, preferably, the needle connection component 107s is made of the same material as the needle 105s, preferably metal, more preferably stainless steel.

[0308] Importantly, the proximal portion 137s of the needle connector 107s is separated from one or more electrodes 113s by a very specific extent. If the distance is too close, current from the electrodes 113s may flow into the needle connector 107s, into the needle 105s, and reach the patient tissue. If the distance is too far, the vapor generated by the electrodes 113s may heat the length of the inner catheter 119s and the outer catheter 109s between the electrodes 113s and the needle connector 107s, exposing tissue that should not be ablated to excessive heat. This could lead to stenosis or premature condensation of the vapor before it passes through the needle 105s, resulting in insufficient vapor reaching the tissue to be ablated. Therefore, in a preferred embodiment, the farthest electrode 133s of the plurality of electrodes 113s within the catheter lumen 129s is separated by the nearest portion 137s of the needle connector 107s by a distance of at least 0.1 mm and no more than 60 mm. These distance ranges ensure that a) current is not transmitted to the tissue via vapor or otherwise; b) sufficient amount of vapor is delivered to the tissue to be ablated; and c) the distance between the vapor generation point and the needle connection component 107s is small, thereby ensuring that the relevant catheter length is not overheated and that the tissue in contact with the catheter length is not over-ablated.

[0309] The needle 105s is defined by a metal housing 115s, a lumen 125s through the metal housing, a sharp and preferably tapered tip 135s, and a proximal needle seat 145s (which can be screwed to or otherwise connected to the needle connection member 107s). The needle 105s also bends in a first direction extending axially from the conduit 109s. In one embodiment, the bending capability of the needle 105s varies depending on the bending direction. For example, the needle 105s may be more bend in a plane parallel to the first direction than in a plane perpendicular to the first direction. Alternatively, the needle 105s may be more bend in a plane perpendicular to the first direction than in a plane parallel to the first direction. Alternatively, the housing 143s of the electrode 113s may also be more bend in one direction than in another. For example, the electrode housing 143s may be more bend in a plane perpendicular to the first direction than in a plane parallel to the first direction. Optionally, the electrode housing 143s may also be more flexible in a plane parallel to the first direction than in a plane perpendicular to the first direction. In an embodiment, the tube 112s at the proximal end of the catheter handle 190s supplies saline solution to the catheter to be converted into vapor. In an embodiment, the user can rotate the dial 192s on the handle 190s to advance or retract the screw 193s connected to the inner catheter 119s, thereby exposing or retracting the needle 105s from the outer catheter 109s. In some embodiments, the outer catheter 109s includes a hypotube with an outer diameter of 3 mm and an inner diameter of approximately 2.5 mm. In some embodiments, the needle 105s is a 25# needle.

[0310] Figure 1T The needle chamber 108t of a system for prostate tissue ablation described in some embodiments of this specification is shown. In one embodiment, the catheter further includes a spacer for the needle 105t and a needle connection component (…). Figure 1SThe telescopic needle chamber 108t is located above the needle 107s. The needle chamber 108t can be retracted using a control on the handle, exposing the needle 105t. To ensure the needle 105t maintains the correct radius of curvature, degree, or range, it preferably adopts a first radius of curvature, degree, or range during operation, before deployment and before being placed in the needle chamber 108t. Before placement in the patient, the needle 105t, adopting the first radius of curvature, degree, or range, is enclosed or covered by the needle chamber 108t, causing the needle 105t to adopt a second radius of curvature, degree, or range. Finally, during use and in the patient, the needle chamber 108t can be retracted, exposing the needle. After the above operations, the needle 105t will adopt a third radius of curvature, degree, or range. In this embodiment, the first radius of curvature, degree, or range is greater than the third radius of curvature, degree, or range, and the third radius of curvature, degree, or range is smaller than the second radius of curvature, degree, or range. In other words, the first radius of curvature, degree, or range is the largest, the third radius of curvature, degree, or range is the smallest, and the second radius of curvature, degree, or range is in between.

[0311] The needle chamber 108t is preferably cylindrical, with its inner surface 118t having a higher hardness or stiffness than its outer surface 128t. Preferably, the outer surface 128t is made of a polymer, while the inner surface 118t contains metal. This ensures that the outer surface 128t of the needle chamber remains undamaged and reduces the likelihood of patient injury, while the inner surface 118t of the needle chamber prevents accidental puncture or damage to the needle 105t itself.

[0312] In another embodiment, the needle chamber 108t can accommodate the needle 105t, conforming to the curvature of the needle 105t. Thus, in one embodiment, the inner lumen 138t of the needle chamber 108t is curved, at least to some extent reflecting the curvature of the needle 105t.

[0313] Finally, a heat insulation layer 175t is placed along the length of the needle 105t and on its outer surface 185t. Sufficient heat insulation layer 175t is used to protect tissue that should not be ablated and to improve vapor distribution kinetics. Measured from the proximal end of the needle 105t, the heat insulation layer preferably extends at least 5% but no more than 90% of the length of the needle 105t, more preferably at least 5% but no more than 75%.

[0314] Figure 1NAn ablation system 110 for endometrial ablation as described in embodiments of this specification is shown. The ablation system 110 includes a catheter 111, which includes a catheter body 115. The catheter body 115 includes an outer catheter 116 and an inner catheter 117 (concentrically positioned within the outer catheter 116 and extendable distally therefrom). The inner catheter 117 includes at least one first distal connecting or positioning member 112 and a second proximal connecting or positioning member 113. The inner catheter 117 is positioned within the outer catheter 116 when the catheter 111 is placed in the patient's cervix or uterus. During catheter 111 placement, the first and second positioning members 112, 113 (initially compressed configuration) are constrained by or positioned within the outer catheter 116. After the distal end of the outer catheter 116 is placed within the patient's cervix, the inner catheter 117 extends distally from the distal end of the outer catheter 116 into the patient's uterus. The first and second positioning members 112, 113 deploy and are positioned within the uterus. In some embodiments, the first and second positioning members 112, 113 include shape memory properties, enabling them to unfold after deployment. In some embodiments, the first and second positioning members 112, 113 are made of a nickel-titanium alloy. In some embodiments, after deployment, the first and second positioning members 112, 113 can contact the uterine wall to place the inner catheter 117 within the uterus; after deployment, the first and second positioning members 112, 113 can be located near the distal portion of the cervix within the uterus to block the flow of ablation vapor back to the cervical os. An internal heating chamber 103 is disposed within the lumen of the inner catheter 117 and can heat the fluid supplied to the catheter 111, converting the fluid into vapor for ablation therapy. In some embodiments, the internal heating chamber is positioned distal to the second positioning member 113. In some embodiments, the catheter 111 is made of or covered with an insulating material to prevent ablation energy from escaping from the catheter body. The inner catheter 117 includes one or more infusion ports 114 for infusing an ablation agent such as vapor. In some embodiments, one or more infusion ports 114 are located on catheter 111 between first and second positioning members 112 and 113. In various embodiments, the first distal connection or positioning member 112 and the second positioning member 113 include a disc. Fluids such as saline are stored in a container (e.g., a saline pump 14) connected to catheter 111. The delivery of the ablation agent is controlled by a controller 15, through which the treating physician controls the treatment. The controller 15 includes at least one processor 23 that communicates data with the saline pump 14 and a catheter connection port 21 in fluid communication with the saline pump 14. In some embodiments, at least one optical sensor 22 monitors changes in the ablation area to guide the flow of the ablation agent. In some embodiments, the optical sensor includes at least one of a temperature sensor or a pressure sensor.In some embodiments, conduit 111 includes a filter 16 with micropores that provide back pressure to the conveyed steam, thereby pressurizing the steam. A predetermined size of the micropores in the filter determines the back pressure, which in turn determines the temperature of the generated steam. In some embodiments, the system further includes a foot pedal 25 in digital communication with controller 15, a switch 27 on conduit 111, or a switch 29 on controller 15 for controlling steam flow.

[0315] In one embodiment, the microprocessor 15 is equipped with a user interface that allows physicians to define devices, organs, and conditions to create default settings for temperature, circulation, volume (sound), and standard radiofrequency settings. In one embodiment, physicians can further modify these default values. The user interface also includes a standard display of all key variables and warnings when values ​​exceed or fall below certain levels.

[0316] In another embodiment, the outer catheter 116 is located close to the cervical canal mucosa, without obstructing the outflow of cervical and uterine cavity fluids. A space is provided between the outer catheter 116 and the inner catheter 117, allowing for venting through a channel to allow heated air, steam, or fluid to escape from the uterine cavity without contacting or damaging the cervical canal.

[0317] The ablation device also includes safety mechanisms to prevent burns to the user, and operates the catheter, including a heat insulation layer, and optionally includes cold air flushing, cold water flushing, and an alarm / bell to indicate the start and stop of treatment.

[0318] Figure 10 As described in some embodiments of this specification Figure 1N Another view of the catheter 111 shown. The catheter 111 includes an elongated body 115 (including a proximal end and a distal end). At the distal end, the catheter body 115 includes an outer catheter 116 and an inner catheter 117 (concentrically positioned within the outer catheter 116 and extending outwardly from its distal end). The inner catheter 117 includes a distal positioning member 112 near its distal end and a proximal positioning member 113 proximal to the distal positioning member 112. In various embodiments, the positioning member is a disc. As described above, the outer catheter 116 accommodates the inner catheter 117 and restricts the positioning members 112, 113 prior to placement. A plurality of infusion ports 114 are located on the inner catheter 117 between the two positioning members 112, 113. The inner catheter 117 also includes at least one heating chamber 103 (located distal to the proximal disc 113). In some embodiments, the heating chamber 103 includes two electrodes 109 that can receive radio frequency current, heat, and convert supplied fluid (such as saline) into vapor or steam for ablation.

[0319] Reference Figure 10To supply current and fluid to catheter 111, a fluid pump 174 and a radiofrequency generator 184 are coupled to the proximal end of body 115. Fluid pump 174 pumps fluids such as saline through a first lumen (extending along the length of body 115) to heating chamber 103. Radiofrequency generator 184 supplies current to electrode 109, causing electrode 109 to generate heat, thereby converting the fluid flowing through heating chamber 103 into vapor. The generated vapor flows through the first lumen and exits from port 114, ablating endometrial tissue. The flexible heating chamber 103 improves the flexibility and maneuverability of catheter 111, allowing physicians to better position catheter 111 when performing ablation procedures, such as ablating a patient's endometrial tissue.

[0320] In various embodiments, the heating electrode 109 is located proximal to the proximal positioning member 113, beyond the distal end of the proximal positioning member 113, or entirely distal to the distal end of the proximal positioning member 113, but not substantially beyond the proximal end of the distal positioning member 112.

[0321] Figure 1PA system 100p for endometrial tissue ablation according to another embodiment of this specification is shown. The ablation system 100p includes a catheter 101p, which in some embodiments includes a handle 190p. The handle 190p includes actuators 191p, 192p, and 193p for forwardly pushing the distal bulbous tip 189p of the catheter 101p forward and for deploying a first distal positioning member 11p and a second proximal positioning member 12p at the distal end of the catheter 101p. In one embodiment, the catheter 101p includes an outer sheath 109p and an inner catheter 107p. In another embodiment, the catheter 101p includes a cervical support 115p, which rests against the external os after the catheter 101p is inserted into the patient's uterus. In another embodiment, the first distal positioning member 11p and the second proximal positioning member 12p are deployable and positioned distal to the inner catheter 107p, and are compressible within the outer sheath 109p for delivery. In some embodiments, actuators 192p and 193p include knobs. In some embodiments, actuator / knob 192b is used to deploy a first distal positioning member 11p. For example, in one embodiment, actuator / knob 192p is rotated a quarter turn to deploy the first distal positioning member 11p. In some embodiments, actuator / knob 193b is used to deploy a second proximal positioning member 12p. For example, in one embodiment, actuator / knob 193p is rotated a quarter turn to deploy the second proximal positioning member 12p. In some embodiments, handle 190p includes only one actuator / knob 192p, which is rotated a first quarter turn to deploy the first distal positioning member 11p, and then rotated a second quarter turn to deploy the second proximal positioning member 12p. In other embodiments, other actuator / knob combinations are used to deploy the first distal positioning member 11p and / or the second proximal positioning member 12p. In some embodiments, catheter 101p includes a port 103p for delivering fluid, such as cooling fluid, during ablation. In some embodiments, port 103p can also be used to collect fluid, provide a vacuum, and provide CO2 for integrity testing. In some embodiments, port 103p is located on handle 190p. In some embodiments, at least one electrode 113p is placed at the distal end of the proximal catheter 101p of the second proximal positioning member 12p. Electrode 113p can receive current supplied by connection line 111p (from controller 15p to catheter 101p) to heat and convert fluid, such as saline, supplied through tube 112p (from controller 15p to catheter 101p). The heated fluid or saline is converted into vapor or steam, which is delivered by port 114p for ablation. In some embodiments, catheter 101p is made of or covered with insulating material to prevent ablation energy from escaping from the catheter body. A plurality of small delivery ports 114p are located on inner catheter 107p between the first distal positioning member 11p and the second proximal positioning member 12p.Port 114p is used for infusing ablative agents, such as steam. The delivery of the ablative agent is controlled by controller 15p, and the treating physician controls the treatment via controller 15p.

[0322] Figure 1Q A controller 15q, used in conjunction with an ablation system according to one embodiment of this specification, is shown. Similar to controllers 15m, 15r, and 15p, controller 15q controls the delivery of ablation agent to the ablation system. Therefore, controller 15q provides a control interface for the physician to control the ablation treatment. Input port 196q on controller 15q is used to connect controller 15q to a catheter and to provide electrical signals to the catheter. Fluid port 198q on controller 15q is used to connect a fluid (e.g., saline) supply source to the catheter via tubing. In an embodiment, a graphical user interface (GUI) 1100q on controller 15q displays the operating settings of the ablation system, which may be in use and / or modified by the physician during use. In some embodiments, the GUI is a touchscreen, enabling the user to control the system.

[0323] Figure 2A and Figure 2B This specification illustrates single-balloon catheters and coaxial double-balloon catheters 245a and 245b according to embodiments of this specification. Catheters 245a and 245b include an elongation body 246, which includes a proximal end 252 and a distal end 253, as well as a first lumen 255, a second lumen 256, and a third lumen 257. In one embodiment, the elongation body 246 is insulated. Catheters 245a and 245b include at least one positioning member 248 near their distal end 253. In various embodiments, the positioning member is an inflatable balloon. In some embodiments, the catheter includes multiple positioning members. Figure 2B As shown, the coaxial conduit 245b includes an outer conduit 246b that can accommodate the elongation body 246.

[0324] exist Figure 2A and Figure 2B In the illustrated embodiment, catheters 245a and 245b include a proximal first inflatable balloon 247 and a distal second inflatable balloon 248 (placed near the distal end of the body 246), with multiple infusion ports 249 located on the body 246 between the two balloons 247 and 248. It should be understood that while balloons are preferred, other positioning components described above may also be used.

[0325] The main body 246 includes a first lumen 255 (extending a portion of the entire length of the main body 246), the first lumen 255 being in fluid communication with a first inlet port 265 of the proximal end 252 of the catheter body 246 and the proximal first balloon 247, through which air is supplied or drawn, and the proximal first balloons 247 and 248 can be inflated or deflated. In one embodiment, using Figure 2A and Figure 2B The illustrated double-balloon catheter results in a seal and forms a treatment area with a radius of 3 cm, a length of 9 cm, a surface area of ​​169.56 cm², and a treatment volume of 254.34 cm³. The body 246 includes a second lumen 256 (extending along the entire length of the body 246), which is in fluid communication with a second inlet port 266 at the proximal end 252 of the catheter body 246 and the distal second balloon 248. Air can be supplied or aspirated through the second lumen 256 to inflate or deflate the distal second balloon 248. In another embodiment, the body includes only a first lumen for fluid communication with the proximal end of the catheter and the first and second balloons to inflate the balloons. The body 246 also includes an in-line heating element 250 disposed within a third lumen 257 (extending along the length of the body 246), which is in fluid communication with a third inlet port 267 at the proximal end 252 of the catheter body 246 and the infusion port 249. In one embodiment, the heating element 250 is placed in a third lumen 257, near and proximal to the infusion port 249. In one embodiment, the heating element 250 includes multiple electrodes. In one embodiment, the electrodes of the heating element 250 are folded back and forth to increase the contact surface area between the electrodes and the liquid supplied to the third lumen 257. The third lumen 257 is used to supply the heating element 250 with a liquid such as water / saline.

[0326] In various embodiments, the distance between the heating element 250 and the nearest port 249 is 1 mm to 50 cm, depending on the type of treatment procedure being performed.

[0327] A fluid pump, an air pump, and a radiofrequency generator are coupled to the proximal end of the main body 246. Through the first and second input ports 265, 266, the air pump pushes air through the first and second lumens to inflate balloons 247, 248, thus securing catheters 245a, 245b at the ablation treatment site. Through the third input port 267, the fluid pump pumps a liquid such as water / saline through the third lumen 257 to the heating element 250. The radiofrequency generator supplies power and current to the electrodes of the heating element 250, thereby heating the electrodes and converting the liquid (flowing around the heating element 250) into vapor. In other embodiments, the electrodes heat the fluid by resistance heating or ohmic heating. The generated vapor is discharged from port 249 for ablation treatment of the target tissue. In this embodiment, the supply of liquid and current, as well as the delivery of vapor, is controlled by a microprocessor.

[0328] Prostate ablation

[0329] For illustrative purposes, Figure 3A The typical anatomical structure of the prostate region is shown. Figure 3B and Figure 3C This is an exemplary perspective view of the anatomical structure of the prostate 302, highlighting the peripheral zone (PZ) 316 in addition to other areas surrounding the prostate 302. Referring to the accompanying drawings, embodiments of this specification may ablate the prostate tissue in the PZ 316, thereby ablating the prostate 302. According to various embodiments of this specification, the prostate tissue 302 may be ablated, but the central zone (CZ) 318 of the prostate tissue may not be completely ablated, thus avoiding damage to the ejaculatory duct 304 emerging from the seminal vesicle 306, which could potentially lead to stenosis of the ejaculatory duct 304. In this specification, "complete ablation" means ablation of more than 55% of the surface area or volume surrounding the anatomical structure.

[0330] The embodiments of this specification can ablate one of many anatomical structures along various treatment pathways for treating prostate 302, thereby ablating prostate 302 tissue. Figure 3AA pathway 310 along the urethra is shown as an exemplary ablation route for the prostate region (also known as the transurethral route). An alternative pathway 312 is also shown, namely, through the intestinal wall between the rectum 314 and the prostate 302. In embodiments, prostate tissue 302 is ablated via the urethra 308 or through the wall of the rectum 314. In either case, embodiments of this specification ensure that greater than 0% and less than 75% of the periurethral zone 324, CZ 318, or any other zone is circumferentially ablated during prostate 302 ablation. In another embodiment, the prostate can be accessed from the base of the bladder around the bladder neck, bypassing the prostate urethra, thus avoiding the risks of prostate urethral ablation and stricture. This pathway is most suitable for ablation of benign or malignant obstructions caused by central zone disease of the prostate or median lobe hypertrophy.

[0331] In one embodiment, the ejaculatory duct 304 is the ablated anatomical structure. In another embodiment, the urethra 308 is ablated, but not completely circumferentially, so as not to cause urethral stricture. In other embodiments, the ablated anatomical structure may include the prostatic capsule (including the rectal wall). In some embodiments, a portion of the prostate 302 or a portion of one or more of CZ 318, PZ 316, transitional zone (TZ) 320, and anterior fibromuscular matrix (AFS) 322 is ablated. Different anatomical structures are ablated, but the continuous circumference of the periurethral zone (PuZ) 324 surrounding the urethra 308 is not ablated. In some embodiments, greater than 0% and no more than 90% of the continuous PuZ 324 circumference is ablated. In some embodiments, greater than 0% and less than 75% of the continuous PuZ 324 circumference is ablated. In some embodiments, greater than 0% and less than 25% of the continuous PuZ 324 circumference is ablated.

[0332] Therefore, in one embodiment, the CZ 318 of the prostate 302 is ablated, while simultaneously, greater than 0% and less than 75% of the prostatic urethra 308 is ablated in a continuous circumferential manner. In another embodiment, the CZ 318 of the prostate 302 is ablated, while simultaneously, greater than 0% and less than 75% of the ejaculatory duct 304 is ablated in a continuous circumferential manner. In one embodiment, the TZ 320 of the prostate 302 is ablated, while simultaneously, greater than 0% and less than 75% of the prostatic urethra 308 is ablated in a continuous circumferential manner. In another embodiment, the TZ 320 of the prostate 302 is ablated, while simultaneously, greater than 0% and less than 75% of the ejaculatory duct 304 is ablated in a continuous circumferential manner. In another embodiment, the median lobe of the prostate 302 is ablated, while simultaneously, greater than 0% and less than 75% of the ejaculatory duct 304 is ablated in a continuous circumferential manner. In one embodiment, greater than 25% to greater than 75% of the majority of the middle lobe or CZ 318 is ablated, but less than 75% of the majority (≥75%) of PuZ 324 is ablated. In one embodiment, greater than 25% to greater than 75% of the majority of TZ 320 is ablated, but less than 75% (≥75%) of AFS 322 is ablated. In some embodiments, 1% to 25% of the prostatic urethra, and each increment thereof, is preferably ablated circumferentially. In some embodiments, 1% to 25% of the ejaculatory duct, and each increment thereof, is preferably ablated circumferentially. In some embodiments, 1% to 25% of the rectal wall, and each increment thereof, is preferably ablated to a certain thickness. In various embodiments, the mucosal layer of the rectal wall is not ablated.

[0333] Figure 4A This specification shows a water-cooled conduit 3100 according to another embodiment, while Figure 4B This shows a cross-section of the tip of the catheter 3100 according to another embodiment of this specification. (Refer to...) Figure 4A and Figure 4B The catheter 3100 includes an elongated body 3105 (including a proximal end and a distal end). The distal end includes a positioning member 3125, such as an inflatable balloon. A plurality of openings 3115 are located adjacent to the distal end, through which a plurality of associated thermally conductive members 3116 (such as needles) can be extended (at an angle to the catheter 3100, wherein the angle is 10-150 degrees) and deployed or retracted. According to one aspect, the plurality of telescopic needles 3116 are all hollow needles and include at least one opening through which an ablative agent, such as vapor or steam 3117, can be delivered when the needles 3116 are extended and deployed through the plurality of openings 3115. Figure 1L and Figure 1MThis is explained. The sheath 3110 extends distally along the body 3105 of the conduit 3100 (including multiple openings 3115). The multiple openings 3115 extend from the body 3105 through the sheath 3110, allowing multiple needles 3116 to extend beyond the sheath 3110 during deployment. In use, cooling fluid 3120 (water or air) is circulated through the sheath 3110 to cool the conduit 3100. Ablation vapor 3117 and cooling fluid 3120 are supplied to the proximal end of the conduit 3100.

[0334] It should be noted that alternative embodiments may include two positioning members or balloons, one located at the distal end and the other near the opening 3115, so that the opening 3115 is located between the two balloons.

[0335] Figure 4C Showing with Figure 1M An embodiment of the distal end of catheter 3100a used in conjunction with the system 101m shown. Figure 4C In the illustrated embodiment, one or more openings 3115a are located near the distal end of the outer sheath 3110a, through which one or more openings 3115a can extend from the inner conduit 3111a (at an angle to the conduit 3100a, wherein the angle is 10°–90°) and deploy or retract one or more associated thermally conductive members 3116a (such as needles). Each needle 3116a includes a beveled edge 3118a (for piercing prostate tissue) and an opening 3117a (for delivering ablative). In some embodiments, each needle 3116a has a gradient coating to provide thermal insulation or echo reflectivity. The coating may be ceramic, polymer, or any other material suitable for coating the needle and providing thermal insulation and / or echo reflectivity to the needle 3116a. The coating is located at various lengths from the tip at the needle seat of the needle 3116a. In some embodiments, each needle 3116a includes a physical gradient in its shape, such as a taper, a beveled tip, or any other structural gradient, to regulate and manage vapor distribution. In some embodiments, the physical shape of the needle is adapted for tissue cutting. The needle edge can pierce the tissue but does not cut or damage it.

[0336] exist Figure 4C In the multi-needle embodiment shown, openings 3115a are provided at equal intervals along the circumferential direction on the outer sheath 3110a. In various embodiments, the openings 3115a can be used to extend one or more needles 3116a. In other embodiments, the openings 3115a and needles 3116a are offset, or provided at unequal intervals along the circumferential direction on the outer sheath 3110a. Figure 4D Showing with Figure 1MOther embodiments of the distal end of the catheter 3100b used with the system 101m shown. One or more openings 3115b are provided around the sheath 3110b at equal distances or circumferentially at the distal edge 3113b of the sheath 3110b. In some multi-needle embodiments, the plurality of openings 3115b provided circumferentially around the sheath 3110b are offset and not necessarily at the same distance at the distal edge 3113b of the sheath 3110b. The distal end of the catheter 3100b may also have a gradient coating to provide thermal insulation or echo reflectivity. The coating may cover 0-100% of the needle surface. In an embodiment, the coating is concentrated on the proximal end of the needle 3116a, thereby providing thermal insulation to the needle. In an embodiment, the coating is concentrated on the distal end of the needle 3116a, making the needle 3116a echo reflective. The coating may be ceramic, polymer, or any other material that can provide thermal insulation and / or echo reflectivity to the needle 3116a. The coating is located at various lengths from the tip of the needle at the needle hub. In some embodiments, the needle includes a physical gradient (shape, taper, or any other gradient) to regulate and manage vapor distribution. In some embodiments, the shape of the needle tip is suitable for tissue cutting. One or more associated thermally conductive members 3116b (such as needles) can extend from the inner conduit 3111b (at an angle to the conduit 3100b, wherein the angle is 10°–90°) and be deployed or retracted through one or more openings 3115b. Each needle 3116b includes a beveled edge 3118b (for piercing prostate tissue) and an opening 3117b (for delivering ablative). See also... Figure 4C and Figure 4D According to one aspect, each telescopic needle 3116a, 3116b is a hollow needle and includes at least one opening 3117a, 3117b through which an ablative agent, such as steam or vapor, can be delivered when the needle 3116a, 3116b is extended and deployed through one or more openings 3115a, 3115b. Figure 1L and Figure 1MThis is further explained. Outer sheaths 3110a, 3110b extend distally along the body of catheters 3100a, 3100b (including multiple openings 3115a, 3115b). The multiple openings 3115a, 3115b extend from the body through the sheaths 3110a, 3110b, allowing multiple needles 3116a, 3116b to extend beyond the sheaths 3110a, 3110b during deployment. In some embodiments, openings 3115a, 3115b are equipped with a locking mechanism for locking needles 3116a, 3116b in their deployment position, thereby preventing compression of 3116a, 3116b. In some embodiments, the locking mechanism operates independently, allowing the user to customize the position of needles 3116a, 3116b according to the disease location, ablation volume, and needle orientation. The locking mechanism is deployed in all embodiments of this specification to treat various conditions, including BPH and AUB. In all the above embodiments, the needle is electrically isolated from the vapor generation chamber by the length of the catheter to electrically insulate the tissue from the radio frequency current delivered to the vapor generation chamber.

[0337] In different embodiments, the size and number of openings 3115a and 3115b may vary. Further, in various embodiments, openings 3115a and 3115b provide steam outlets, may have the same size along the length of sheaths 3110a and 3110b, and may have different patterns, including but not limited to: spiral, circular, or any other pattern. Further, openings 3115a and 3115b may have a certain size gradient, thereby forcing steam to distribute to certain areas of the anatomical structure. In one exemplary embodiment, the size of openings 3115a and 3115b may differ by at least (but not limited to) 10% from top to bottom or from bottom to top. Furthermore, openings 3115a and 3115b may have different shapes, such as circular, elliptical, or any other shape.

[0338] Figure 4E This specification shows some embodiments of the method for covering Figure 4C and Figure 4D An embodiment of the slit cap for the openings 3115a, 3115b is shown. In this embodiment, the slit cap 3119 is made of metal, including but not limited to silicone or polyurethane (PU). The slit cap 3119 is placed above each opening 3115a, 3115b. Multiple slit caps 3118 can extend (at an angle to the conduits 3100a, 3100b, wherein the angle is 30°-90°) and deploy or retract needles 3116a, 3116b.

[0339] Figure 4FAn embodiment of the positioning member 4125 described herein is shown, located at the distal end of an ablation catheter for placement in the prostatic urethra. In some embodiments, as described in the embodiments herein, a positioning member of the same shape as member 4125 is also used in the uterus for endometrial ablation. In one embodiment, the positioning member comprises multiple threads 4126 woven into a pattern (e.g., a thread pattern). In another embodiment, the threads 4126 are composed of a shape memory material, thus compressible during delivery. In some embodiments, the shape memory material is a nickel-titanium alloy. In various embodiments, the positioning member 4125 is funnel-shaped, bell-shaped, spherical, elliptical, oval, or rubber-shaped, and substantially cylindrical when compressed. During deployment, the positioning member 4125 is positioned close to and against the bladder or bladder neck.

[0340] Figure 4G-Figure 4L The use of catheter 4100 as described in this specification (and) Figure 4C , Figure 4D and Figure 4E An exemplary step of an embodiment (similar to the catheter shown) is to ablate prostate tissue 4130. The outer catheter or sheath 4110 includes an inner catheter 4105. Figure 4G The illustration shows the distal end of catheter 4100 being pushed through the prostatic urethra 4128. In an embodiment, the distal end 4119 of catheter 4100 includes a folded tip 4109, which can be pushed through or placed close to the patient's bladder 4132. In an embodiment, the folded tip 4109 is curved or is an elbow tip. Figure 4H This shows the distal end of catheter 4100 being pushed into bladder 4132. Figure 4I This shows the distal end of catheter 4100 being pushed further into bladder 4132. (As shown) Figure 4H and Figure 4I As shown, the outer sheath 4110 is slightly retracted, exposing the distal end of the catheter 4105. At this time, the positioning member 4125 is in a compressed configuration. (Refer to...) Figure 4J Deploy the positioning member 4125, retract the catheter 4100, and place the positioning member 4125 near the bladder neck 4134 or at the distal end of the prostatic urethra 4128. (Refer to...) Figure 4K A needle 4116 extends from the catheter 4100 and enters the prostate tissue 4130. In embodiments, needle 4116 refers to at least one needle; in some embodiments, it refers to multiple needles. In embodiments, according to... Figure 4A , 4C The embodiment shown in 4D deploys and extends pin 4116. (Refer to...) Figure 4L The ablative agent 4136 is delivered to the prostate tissue 4130 through needle 4116.

[0341] In an alternative embodiment, refer to Figure 4M The catheter 4100a includes a positioning member 4125a (placed on the catheter 4100a proximal to the needle 4116a, and conversely, on the distal end of the catheter 4100a). In other embodiments, the catheter includes a plurality of needles. The catheter includes an outer sheath 4110a and an inner catheter 4105a. The positioning member 4125a and the needle 4116a are placed on the inner catheter 4105a, with the needle 4116a distal to the positioning member 4125a. Figure 4M As shown, the catheter 4100a is pushed into the prostatic urethra 4128a using the needle 4116a and the positioning member 4125a (in the contraction configuration). (Refer to...) Figure 4N The positioning member 4125a is deployed to secure the catheter 4100a within the prostatic urethra 4128a, and the needle 4116a is deployed into the prostatic tissue 4130a to deliver the ablation agent. In various embodiments, the positioning member 4125a is funnel-shaped, bell-shaped, spherical, elliptical, oval, or rubber-shaped during deployment and substantially cylindrical when compressed.

[0342] Figure 4O This is a flowchart illustrating the ablation of a patient's prostate using an ablation catheter as described in the embodiments of this specification, listing the steps involved. In step 4140, the folded tip of the catheter is pushed through the patient's prostatic urethra, and the distal end of the catheter is placed against the patient's bladder. In step 4142, the outer sheath of the catheter is retracted using an actuator, exposing a positioning member or bladder anchor, and the positioning member is placed in the bladder neck to position the ablation catheter. In step 4144, the outer sheath is further retracted to deploy one or more needles from the catheter into the prostate tissue. In some embodiments, the one or more needles are deployed outside the inner lumen of the inner catheter and through slots in the outer sheath. In another embodiment, the sheath folds outward naturally upon retraction of the outer sheath. In step 4146, vapor or steam is delivered through the one or more needles to ablate the prostate tissue.

[0343] Figure 5A This specification illustrates an embodiment of the use of a catheter (e.g.) Figure 4AA catheter 3100 with two positioning members is shown for prostate ablation of an enlarged prostate in the male urinary system. A cross-section of the male urogenital tract, including an enlarged prostate 3201, a bladder 3202, and a urethra 3203, is shown. The enlarged prostate 3201 compresses the urethra 3203. An ablation catheter 3205 is passed through a cystoscope 3204 located distal to the obstruction in the urethra 3203. Positioning members 3206 are deployed to position the catheter centrally in the urethra 3203, and one or more heat-resistant needles 3207 are used to puncture the prostate 3201. Vapor ablation agent 3208 flows through the heat-resistant needles 3207, ablating the diseased prostate tissue and thereby shrinking the prostate. In one embodiment, only the proximal positioning member is used, while in another embodiment, only the distal positioning member is used.

[0344] The size of an enlarged prostate can be calculated based on the difference between the internal and external urethra of the prostate. Standard values ​​can be used as a baseline. When delivering ablation energy to the prostate for ablation, cooling fluid is injected into the urethra through an additional port to prevent urethral damage and thus prevent complications such as stricture.

[0345] In one embodiment, the distance between the positioning connector and the ablation area must be greater than 0.1 mm, preferably 1 mm to 5 mm and not exceeding 2 cm. In another embodiment, the positioning connector can be deployed into the bladder and pulled back into the urethral opening / bladder neck to secure the catheter. In one embodiment, the diameter of the positioning device is 0.1 mm to 10 cm.

[0346] Figure 5B This specification illustrates an embodiment of the use of an ablation device (e.g., Figure 4A The catheter 3100 shown has a positioning component and performs transurethral prostate ablation on an enlarged prostate 3201 in the male urinary system. Figure 5B The bladder 3202 and prostatic urethra 3203 are also shown. An ablation catheter 3223, having a handle 3220 and a positioning member 3228, is inserted into the urethra 3203 and pushed into the bladder 3202. The positioning member 3228 is inflated and pulled to the junction of the bladder and urethra, keeping the needle 3207 at a predetermined distance from the junction. In some embodiments, the positioning member 3228 is inflated to a first volume near the junction of the bladder 3202 and urethra 3203 in the bladder 3202, bringing the needle 3207 close to the prostate 3201; the positioning member is then inflated to a second volume different from the first volume, positioning the needle 3207 at different locations near the prostate 3201. A balloon is used as the positioning member 3228 to provide counteracting traction during needle 3207 deployment.

[0347] Then, using a pusher 3230, the needle 3207 is pushed from the catheter 3223 through the urethra into the prostate 3201 at an angle of 10°-90°. A port 3238 extends from the opening 3237 in the needle 3207 into the prostate tissue via the axis of the catheter 3223. Steam is applied through the port 3238 to ablate the prostate tissue. In embodiments, the steam is delivered at a predetermined time, predetermined pressure, and predetermined energy. In some embodiments, the steam delivery time is less than five minutes, preferably 2-120 seconds, more preferably 60-90 seconds. In embodiments, the steam delivery pressure is less than 5 atm, and in some cases less than 1 atm, preferably not exceeding 10% above atmospheric pressure. In embodiments, the steam delivery energy is 10-10,000 calories.

[0348] In one embodiment, needle 3207 is heat-insulated to prevent damage to the prostatic urethra 3203 or the periurethral zone. Furthermore, in embodiments, the needle may deliver steam at a location preferably away from the ejaculatory duct. In some embodiments, needle 3207 has a different shape during steam delivery compared to before.

[0349] Optional port 3239 allows cold fluid with a temperature <37°C to enter through opening 3240 to cool the prostatic urethra 3203 or the perineal zone. Optional temperature sensor 3241 can be installed to detect the temperature of the prostatic urethra and regulate vapor delivery.

[0350] Figure 5C This specification illustrates a different embodiment of the use of an ablation device to perform transurethral prostate ablation of an enlarged prostate 3201 in the male urinary system. Figure 5C The bladder 3202 and prostatic urethra 3203 are also shown. An ablation catheter 3223, having a handle 3220 and a positioning member 3248, is inserted into the urethra 3203 and pushed into the bladder 3202. The positioning member 3248 is a compressible disc that unfolds within the bladder 3202 and is pulled to the junction of the bladder and urethra, maintaining a predetermined distance between the needle 3207 and this junction. In some embodiments, the positioning member 3248 is unfolded to a first size near the junction of the bladder 3202 and urethra 3203 within the bladder 3202, bringing the needle 3207 close to the prostate 3201; the positioning member is then unfolded to a second size different from the first size, positioning the needle 3207 at different locations near the prostate 3201.

[0351] Then, using a pusher 3230, the needle 3207 is pushed from the catheter 3223 through the urethra into the prostate 3201 at an angle of 10°-90°. A port 3238 extends from the opening 3237 in the needle 3207 into the prostate tissue via the axis of the catheter 3223. Steam is applied through the port 3238 to ablate the prostate tissue. In embodiments, steam is delivered at predetermined times, predetermined pressures, and predetermined energies. In some embodiments, the steam delivery time is less than five minutes, preferably 60-90 seconds. In other embodiments, the steam delivery time is 2-30 seconds. In yet another embodiment, the steam delivery time is 30-60 seconds. In embodiments, the steam delivery pressure is less than 5 atm, and in some cases less than 1 atm, preferably not exceeding atmospheric pressure by more than 10%.

[0352] In one embodiment, needle 3207 is heat-insulated to prevent damage to the prostatic urethra 3203 or the periurethral zone. Furthermore, in embodiments, the needle may deliver steam at a location preferably away from the ejaculatory duct. In some embodiments, needle 3207 has a different shape during steam delivery compared to before.

[0353] Optional port 3239 allows cold fluid with a temperature <37°C to enter through opening 3240 to cool the prostatic urethra 3203 or the perineal zone. Optional temperature sensor 3241 can be installed to detect the temperature of the prostatic urethra and regulate vapor delivery.

[0354] Figure 5D This is a flowchart illustrating transurethral ablation of an enlarged prostate using an ablation catheter, as described in one embodiment of this specification, and lists the steps involved in the process. In step 3212, the ablation catheter (e.g., Figure 4A The catheter (3100) shown is inserted into the urethra and advanced until its distal end enters the bladder. Then, in step 3214, a positioning member is deployed at the distal end of the catheter, and the proximal end of the catheter is pulled to bring the positioning member close to the junction of the bladder and urethra, thereby placing the catheter shaft within the urethra. In step 3216, the advance mechanism at the proximal end of the catheter is activated, deploying a needle that travels from the catheter shaft through the urethra into the prostate tissue. In step 3218, an ablative agent is delivered into the prostate via the needle, ablating the target prostate tissue.

[0355] Figure 5E This specification illustrates an embodiment of transrectal prostate ablation using an ablation device in the male urinary system. Figure 5EThe bladder 3202 and prostatic urethra 3203 are also shown. The ablation device includes a catheter 3223 with a needle tip 3224. The enlarged prostate 3201 can be visualized by inserting an endoscope 3222 into the rectum 3221. In various embodiments, the endoscope 3222 is an endoscopic ultrasound or transrectal ultrasound device, allowing visualization of the endoscopy using radiography. The catheter 3223 with a needle tip 3224 passes through the working channel of the endoscope, and the needle tip 3224 enters the prostate 3201 transrectally. Figure 5G This is a close-up view of the distal end of catheter 3223 and needle tip 3204. The ablation agent is then delivered into the prostate tissue through needle tip 3224 for ablation. In some embodiments, the prostate tissue is ablated without resulting in full-thickness ablation of the rectal wall. In some embodiments, the rectal wall ablation thickness does not exceed 90%. In some embodiments, the rectal wall ablation thickness is 0% to 75%. In some embodiments, the rectal wall ablation thickness is preferably in the range of 1% to 25%, and may be in each increment therein. In some embodiments, the mucosal layer of the rectal wall is not ablated.

[0356] In one embodiment, the catheter 3223 and the needle tip 3224 are made of thermally insulating material. In various embodiments, the needle tip 3224 is an echo- or acoustically transparent tip that can be observed using radiography, used for precise positioning in prostate tissue. In one embodiment, an optional catheter (not shown) may be placed in the urethra to allow fluid to flow in and cool the prostatic urethra 3203. In one embodiment, the temperature of the introduced fluid is below 37°C.

[0357] Figure 5F This specification illustrates a different embodiment of the use of a coaxial ablation device with a positioning member for transrectal prostate ablation of an enlarged prostate in the male urinary system. Figure 5F The bladder 3202 and prostatic urethra 3203 are also shown. The ablation device includes a coaxial catheter 3223. The coaxial catheter 3223 includes an inner catheter with a needle tip 3224 and an outer catheter with a positioning member 3228. The enlarged prostate 3201 can be visualized by inserting the endoscope 3222 into the rectum 3221. In various embodiments, the endoscope 3222 is an endoscopic ultrasound or transrectal ultrasound device, allowing visualization of the endoscopy using radiography. The coaxial catheter 3223 with the needle tip 3224 and the positioning member 3228 passes through the working channel of the endoscope, with the positioning member 3228 resting against the rectal wall, and the inner catheter is advanced through the rectum, thereby placing the needle tip 3224 to a predetermined depth in the prostate 3201. Figure 5GThis is a close-up view of the distal end of catheter 3223 and needle tip 3204. In one embodiment, the positioning member is a compressible disc having a first pre-deployment compression structure and a second post-deployment deployment structure as it extends beyond the distal end of endoscope 3222. Ablation agent is then delivered into the prostate tissue via needle tip 3224 for ablation. In this embodiment, the prostate tissue is ablated without resulting in full-thickness ablation of the rectal wall. In some embodiments, the rectal wall ablation thickness does not exceed 90%. In some embodiments, the rectal wall ablation thickness is 0%-75%. In some embodiments, the rectal wall ablation thickness is preferably in the range of 1%-25%, and may be each increment therein. In some embodiments, the mucosal layer of the rectal wall is not ablated.

[0358] In one embodiment, the coaxial catheter 3223, needle tip 3224, and positioning member 3228 are made of thermally insulating material. In various embodiments, the needle tip 3224 is an echo- or acoustically transparent tip that can be observed using radiography, used for precise positioning in prostate tissue. In one embodiment, an optional catheter (not shown) may be placed in the urethra to allow fluid to flow in and cool the prostatic urethra 3203. In one embodiment, the temperature of the introduced fluid is below 37°C.

[0359] Figure 5H This is a flowchart illustrating the steps involved in a transrectal ablation procedure for enlarged prostate using an ablation catheter, as described in one embodiment of this specification. In step 3242, an endoscope is inserted into the patient's rectum to observe the prostate. Then, in step 3244, a catheter with a needle tip is advanced sequentially through the working channel of the endoscope, the rectal wall, and finally into the prostate. In step 3246, the needle is radiographically guided into the target prostate tissue. In step 3248, an ablation agent is delivered into the prostate through the needle to ablate the target prostate tissue. In this embodiment, the prostate tissue is ablated, but the entire thickness of the rectal wall is not ablated. In some embodiments, only 90% of the rectal wall thickness is ablated. In some embodiments, 0%-75% of the rectal wall thickness is ablated. In some embodiments, preferably, 1%-25% (corresponding increments) of the rectal wall thickness is ablated. In some embodiments, the mucosal layer of the rectal wall is not ablated.

[0360] Figure 6A It is the ablation catheter 3300 shown in the embodiments of this specification, and Figure 6B This is a cross-section of the tip of the catheter 3300 shown in the embodiment of this specification. Reference Figure 6A and Figure 6BThe conduit 3300 includes an elongated body 3305 having a proximal end and a distal end. A plurality of openings 3315 and an inflatable balloon 3325 are adjacent to the distal end. The plurality of openings 3315 allow a plurality of associated thermally conductive members 3316 (e.g., needles) to extend (at an angle to the conduit 3300, wherein the angle ranges from 30° to 90°) or retract through the plurality of openings 3315. According to one aspect, the plurality of retractable needles 3316 are hollow structures and include at least one opening to allow the delivery of an ablative agent, such as vapor or vapor 3317, through the needles 3316 as they extend and unfold through the plurality of openings 3315. The plurality of openings 3315 extend from the body 3305 and through the balloon 3325 to allow the plurality of needles 3316 to extend through the balloon 3325 upon unfolding.

[0361] A heating chamber 3310 is located proximal to the conduit 3300. The heating chamber 3310 includes a metal coil wound around a ferromagnetic core. Water is injected into the chamber 3310 through an inlet 3311 located proximal to the chamber 3310. An alternating current is applied to the coil, generating a magnetic field that induces a current in the ferromagnetic core, thereby heating the chamber 3310 and causing the water to evaporate. The generated steam or vapor 3317 is discharged from the needles 3316 to ablate the target tissue. Coolant is filled into the balloon 3325 through a coolant port 3312 proximal to the chamber 3310, thereby inflating the balloon 3325. In use, coolant is injected into the balloon 3325 while the steam or vapor 3317 generated in the chamber 3310 is delivered through multiple needles 3316. As the needles 3316 pierce the target tissue during use, the steam or vapor 3317 delivered through the piercing needles ablates tissue deep within the target tissue. An inflatable balloon 3325 filled with coolant contacts the surface of non-target tissue and stabilizes the ambient temperature on the non-target tissue surface at a desired level, such as below 60°C in some embodiments. Steam or vapor 3317 ablates deeper target tissue without circumferentially ablating non-target tissue on the surface. In some embodiments, a heating chamber 3310 is located adjacent to the distal end of a catheter with proximal needle 3316 and multiple openings 3315, and is configured to generate steam using radiofrequency energy via resistive or ohmic heating of saline solution. In all embodiments, multiple needles are electrically insulated from the heating chamber 3310 via a catheter 3305 to prevent radiofrequency current from the electrodes from entering the tissue or body. In various embodiments, a non-conductive ablative agent, such as a conductive fluid like saline solution, is heated to vapor to minimize the probability of radiofrequency current entering the prostate tissue and patient body from the heating chamber. Ideally, the patient is isolated from the radiofrequency current to avoid interference with any implanted electronic medical devices.

[0362] Figure 6C This is one embodiment of the use described in this specification. Figure 6AIllustration of a 3300 ablation catheter used for prostate ablation in the male urinary system. Figure 6C The text also describes prostate 3330 and prostatic urethra 3332. (Reference) Figure 6A and Figure 6C An ablation catheter 3300, equipped with a heating chamber 3310 and an inflatable cooling balloon 3325, is inserted into the patient's urethra and advanced into the prostatic urethra 3332 to position multiple openings 3315 near the tissue to be ablated. Coolant is filled into the balloon through a coolant port 3312, causing the cooling balloon 3325 to inflate. The inflated cooling balloon 3325 is adjacent to the surface of the prostatic urethra of the prostatic tissue to be ablated. Using a pusher, a needle 3316 is advanced from the catheter 3300 and pushed into the prostate 3330 from an angle (ranging from 10° to 90° in different embodiments). Water (through an inlet 3311) is injected into the chamber 3310, where it is converted into steam or vapor 3317. The steam or vapor 3317 passes through the body 3305 of the catheter and exits through the openings of the needle 3316 into the prostatic tissue, thereby ablating the prostatic tissue. In one embodiment, needle 3316 is thermally insulated. An inflatable balloon 3325 filled with coolant stabilizes the ambient temperature of the prostatic urethral tissue surface at a desired level, for example, below 60°C in some embodiments. Steam or vapor 3317 is capable of ablating deeper target tissue without circumferentially ablating the surface of the prostatic urethral tissue. An optional temperature sensor may be installed to detect the temperature of the prostatic urethra and regulate steam delivery. In some embodiments, a heating chamber 3310 is located distal to the catheter adjacent to the proximal needle 3316 and the plurality of openings 3315, and is configured to generate steam using radiofrequency energy through resistive or ohmic heating of saline solution. In embodiments, the needle is separated from the radiofrequency electrodes by a thermally insulated section of the catheter to minimize or prevent radiofrequency current from entering the patient tissue and to avoid electrical interference with the electro-medical implant.

[0363] Figure 6D This is an embodiment of the usage described in this specification. Figure 6A A flowchart illustrating the steps involved in transurethral ablation of an enlarged prostate using a 3300 ablation catheter. (Refer to...) Figure 6A and Figure 6DIn step 3340, the ablation catheter 3300 is inserted into the urethra and advanced until multiple openings 3315 are adjacent to the prostate tissue to be ablated within the prostatic urethra. In step 3342, a cooling balloon 3325 is inflated using coolant supplied through coolant port 3312, thereby securing the catheter 3300 within the prostatic urethra and maintaining the ambient temperature of the surface of the tissue to be ablated. In step 3344, a needle 3316 is advanced from the catheter 3300 at an angle (ranging from 30° to 90° in different embodiments) using a pusher, passing through the prostatic urethra and advancing into the prostate to the desired depth. Vapor is delivered through the openings in the needle 3316 and introduced into the prostate tissue at the desired depth, thereby ablating the prostate tissue without ablating the surface of the prostatic urethra. The temperature of the prostatic urethral surface is monitored using an optional temperature sensor, and the flow rate of coolant is controlled or regulated to stabilize the temperature of the prostatic urethral surface at a level, for example, below 60°C.

[0364] Figure 7A The ablation catheter 3400 shown in the embodiments of this specification is illustrated. Figure 7B This is a cross-section of the tip of the catheter 3400 shown in an embodiment according to this specification. Reference is made herein. Figure 7A and Figure 7B The conduit 3400 includes an elongated body 3405 having a proximal end and a distal end. A plurality of first openings 3415, a plurality of second openings 3418, and a silicone or polytetrafluoroethylene member 3425 covering the plurality of first and second openings are adjacent to the distal end. The plurality of openings 3415 allow a plurality of associated thermally conductive members 3416 (e.g., needles) to extend (at an angle to the conduit 3400, ranging from 20° to 90°) or retract through the plurality of openings 3415. The plurality of second openings 3418 allow coolant 3419 supplied via a coolant port 3412 at the proximal end of the conduit 3400 to be delivered to the ablation band. According to one aspect, the plurality of retractable needles 3416 are hollow and include at least one opening to allow delivery of ablation agent such as vapor or vapor 3417 through the needles 3416 as the needles extend and unfold through the plurality of first openings 3415. Multiple openings 3415 extend from the body 3405 and through the balloon 3425 to allow multiple needles 3416 to extend through the balloon 3425 when deployed. The needles 3416 pierce the membrane 3425 when deployed, so that the membrane 3425 isolates the needles 3416 as they deploy and pierce the target tissue.

[0365] A heating chamber 3410 is located at the proximal end of catheter 3400. The heating chamber 3410 includes a metal coil wound around a ferromagnetic core. Water is introduced into the chamber 3410 through an inlet 3411 located at the proximal end of the chamber 3410. An alternating current is applied to the coil, generating a magnetic field that induces a current in the ferromagnetic core, thereby heating the chamber 3410 and causing the water therein to evaporate. The generated steam or vapor 3417 is discharged from needles 3416 to ablate target tissue. Coolant 3419 is delivered into the prostatic urethra through a coolant port 3412 at the proximal end of the chamber 3410, via a plurality of second openings 3418. In use, coolant 3419 is delivered to the ablation band through the coolant openings 3418, while steam or vapor 3417 generated in the chamber 3410 is delivered through the plurality of needles 3416. In some embodiments, the heating chamber 3410 is located adjacent to the catheter body at opening 3415 and is configured to generate steam or vapor using radio frequency resistance heating.

[0366] As the needle 3416 penetrates the target tissue during use, steam or vapor 3417 delivered through the puncture needle 3416 ablates tissue located deep within the target tissue. Coolant 3419 directly contacts the surface of the non-target urethral tissue and stabilizes the ambient temperature on the non-target tissue surface at a desired level, such as below 60°C in some embodiments, thereby preventing or mitigating significant or circumferential thermal damage to the non-target tissue clinically. This allows the steam or vapor 3417 to ablate deeper prostate tissue without causing circumferential ablation of the surface urethral tissue. Furthermore, a membrane 3425 isolates the puncture needle 3416 and prevents the coolant 3419 from significantly cooling the needle 3416. In some embodiments, a heating chamber 3410 is located distal to the catheter adjacent to the proximal needle 3416 and the plurality of openings 3415, and is configured to generate steam using radiofrequency energy through resistive or ohmic heating of saline. The catheter is optimized to minimize radiofrequency current leakage into the tissue. In any case, the leakage is insufficient to cause significant clinical ablation damage.

[0367] Figure 7C This is one embodiment of the use described in this specification. Figure 7A Illustration of a 3400 ablation catheter used for prostate ablation in the male urinary system. Figure 7C The text also describes the prostate 3430 and the prostatic urethra 3432. See here for reference. Figure 7A and Figure 7CAn ablation catheter 3400, equipped with a heating chamber 3410 and an inflatable cooling balloon 3425, is inserted into the patient's urethra and advanced into the prostatic urethra 3432, so that multiple first openings 3415 and multiple second openings 3418 are adjacent to the prostatic tissue to be ablated. Coolant 3419 is delivered into the prostatic urethra 3432 through the multiple second openings 3418. Using a pusher, a needle 3416 is pushed out of the catheter 3400 and into the prostate 3430 from an angle (ranging from 30° to 90° in different embodiments). The pushed-out needle 3416 also penetrates or passes through the heat-insulating membrane 3425 covering the openings 3415.

[0368] Water or saline solution (through inlet 3411) is injected into chamber 3410, where it is converted into steam or vapor 3417. The steam or vapor 3417 passes through the body 3405 of the catheter and exits through the opening of needle 3416, entering the prostate tissue to ablate it. Needle 3416 is insulated by membrane 3421, while needle 3416 penetrates membrane 3425. An inflatable balloon 3425 filled with coolant and coolant 3419 delivered to the prostatic urethra 3432 via multiple second openings 3418 stabilize the ambient temperature on the surface of the prostate tissue at a desired level, for example, below 60°C in some embodiments, and preferably below 40°C in other embodiments. The steam or vapor 3417 can ablate deeper target tissue without clinically significantly or circumferentially ablating the surface of the prostatic urethra tissue. An optional temperature sensor can be installed to detect the temperature of the prostatic urethra and regulate the delivery of steam or vapor 3417 and / or coolant 3419.

[0369] Figure 7D This is an embodiment of the usage described in this specification. Figure 7A A flowchart illustrating the steps involved in transurethral ablation of an enlarged prostate using a 3400 ablation catheter. (Refer to...) Figure 7A and Figure 7DIn step 3440, the ablation catheter 3400 is inserted into the urethra and advanced until multiple first openings 3415 are adjacent to the prostate tissue to be ablated within the prostatic urethra. In step 3442, a cooling balloon 3425 is inflated using coolant supplied through a coolant port 3412, thereby securing the catheter 3400 within the prostatic urethra and maintaining the ambient temperature of the surface of the tissue to be ablated. In step 3444, a needle 3416 is pushed out of the catheter 3400 from an angle (ranging from 10° to 90° in different embodiments) using a pusher, sequentially passing through the insulating membrane 3421, the prostatic urethra, and into the prostate at the desired depth. Steam or vapor 3417 is delivered through the opening in the needle 3416 and introduced into the prostate tissue at the desired depth, thereby ablating the prostate tissue without ablating the surface of the prostatic urethra. In step 3446, coolant 3419 is injected into the prostatic urethra through multiple second openings 3418 to maintain the ambient temperature of the surface of the prostate tissue to be ablated. Membrane 3421 isolates the puncture needle 3416 from the coolant 3419 injected into the prostatic urethra. An optional temperature sensor monitors the temperature of the prostatic tissue surface and controls or regulates the flow rate of the coolant to maintain the temperature of the prostatic tissue surface below a specific temperature level, such as below 60°C in some implementations.

[0370] Refer again Figure 6A and Figure 7A According to some embodiments, pumps such as injection pumps or peristaltic pumps are used to control the flow rate of water toward heating chambers 3310 and 3410.

[0371] In various embodiments, the catheter of this specification further includes at least one thermally conductive member connected to the positioning member. The at least one thermally conductive member is configured to physically contact the target tissue and, in some embodiments, penetrates the target tissue and enhances the transfer of heat energy into the target tissue for ablation. Figure 8AThe illustration depicts one embodiment of the positioning member 3571 of the ablation catheter 3570, showing a plurality of thermally conductive members 3572 connected thereto. In various embodiments, the positioning member 3571 is an inflatable balloon. The positioning member or balloon 3571 is inflated to a first volume to bring the thermally conductive member 3572 into contact with the target tissue. The ablation agent is then delivered to the target tissue through the catheter 3570 and exited through at least one delivery port at the distal end of the catheter 3570. The thermal energy of the ablation agent is transferred from the lumen of the catheter 3570 to the air in the balloon 3571, further expanding the volume of the balloon 3571 and pushing the thermally conductive member 3572 further into the target tissue. The thermal energy of the air in the balloon 3571 is transferred to the thermally conductive member 3572 and released into the target tissue for ablation. In various embodiments, the thermally conductive member 3572 comprises a solid or hollow metal pin or needle. In different embodiments, the balloon 3571 is made of thermal insulation material, so that the ablation heat energy is mainly transferred to the target tissue from the thermally conductive component 3572.

[0372] Figure 8BThis is an illustration of one embodiment of the positioning member 3571 of the ablation catheter 3570, showing a plurality of hollow thermally conductive members 3573 connected thereto. In one embodiment, each hollow thermally conductive member 3573 includes a valve 3583 located at the inlet of the lumen connecting the positioning member 3571 and the lumen of the hollow thermally conductive member 3573. In a different embodiment, the positioning member 3571 is an inflatable balloon. The positioning member or balloon 3571 is inflated to a first volume, causing the thermally conductive member 3572 to contact the target tissue. The ablation agent is then delivered to the target tissue through the catheter 3570 and exited through at least one delivery port at the distal end of the catheter 3570. The thermal energy of the ablation agent is transferred from the lumen of the catheter 3570 to the air in the balloon 3571, further expanding the volume of the balloon 3571 and pushing the thermally conductive member 3573 further into the target tissue. The thermal energy of the air in the balloon 3571 is transferred to the thermally conductive member 3573 and released into the target tissue for ablation. In various embodiments, the thermally conductive member 3573 comprises a hollow metal pin or needle. The thermally conductive member 3573 includes at least one opening at its distal end that is in fluid communication with a lumen of the thermally conductive member 3573, which in turn is in fluid communication with the interior of the balloon 3571. As seen in the cross-section of the conduit 3570, vapor travels along a first passage 3584 from the interior of the balloon 3571 through the thermally conductive member 3573 and flows into the target tissue. In one embodiment, each thermally conductive member 3573 includes a valve 3583 located at its connection to the balloon 3571 for controlling the vapor flow rate of each hollow thermally conductive member 3573. In one embodiment, vapor also enters the interior of the balloon 3571 along a second passage 3585 to transfer heat and promote the inflation of the balloon 3571. In another embodiment, a flexible tube 3586 connects the lumen of each thermally conductive member 3573 to the lumen of the conduit 3570, bypassing the interior of the balloon 3571. In one embodiment, the tube 3586 is made of silicone resin. In this embodiment, steam can only flow along the first passage 3584, and air 3587 is used to inflate the balloon 3571. In different embodiments, the balloon 3571 is made of insulating material, such that the ablation heat energy is primarily transferred to the target tissue from the heat-conducting member 3573. In different embodiments, the heat-conducting member 3573 has shape memory properties, and its shape can change from approximately parallel to the catheter 3570 to approximately perpendicular to the catheter 3570 within a temperature range from below to above the patient's body temperature.

[0373] Figure 9This is a flowchart illustrating one embodiment of a method for ablating tissue using the needle-catheter device described above. The device includes a thermally insulated catheter having a hollow shaft and a retractable needle through which ablation agent can pass; at least one infusion port on the needle for delivering the ablation agent; at least one positioning member at the distal end of the catheter; and a controller including a microprocessor for controlling the delivery of the ablation agent. (Refer to...) Figure 9 In the first step 3601, a catheter is inserted such that the positioning member is adjacent to the tissue to be ablated. The next step 3602 involves extending a needle through the catheter such that the infusion port is adjacent to the tissue. Finally, in step 3603, ablative agent is delivered through the infusion port to ablate the tissue. In another embodiment, the device does not include a positioning member, and the method does not include the step of positioning the positioning member near the tissue to be ablated.

[0374] In one embodiment, Figure 35A and Figure 35B The needle catheter device described in the text is also used for vapor ablation of submucosal tissues.

[0375] Figure 10 This is a flowchart illustrating a method for ablating submucosal tissue using a needle catheter device similar to that described above. (See also...) Figure 10 First, in step 3701, the endoscope is inserted into the main lumen so that the distal end of the main lumen is adjacent to the tissue to be ablated. In step 3702, a vapor delivery needle is used to puncture the submucosal space, the vapor delivery needle passing through the working channel of the endoscope via a catheter. In step 3703, vapor is delivered into the submucosal space to primarily ablate the submucosal layer and / or the mucosa without causing irreversible or significant ablation of the deep muscle layer or serosa. In one embodiment, in step 3704, the mucosa may optionally be excised with a vise or needle knife for histological evaluation. In some embodiments, the submucosal layer is pretreated with an injection of physiological saline, glucose solution, glycerol, sodium hyaluronate (SH), colloid, hydroxypropyl methylcellulose, fibrinogen solution, autologous blood, or other substitutes or reagents known in the art, such as Eleview™, to create a submucosal elevation.

[0376] In another embodiment, this specification discloses a modified needle for prostate tissue ablation. Figure 11A This is an exemplary illustration of a deformable needle. (Refer to...) Figure 11ANeedle 3801a is made of a flexible material such as nitinol and has a curvature of -30° to 120°. In some embodiments, the needle tip curvature is 0° to 180°. In one embodiment, the curvature of needle 3801a increases when heated, as shown in 3801b. In one embodiment, the curvature range of the needle increases to -30° to 120° for a temperature increase in the range of 25° to 75°. According to one aspect, needle 3801a is a hollow structure and includes at least one opening to allow the delivery of an ablative agent such as steam or vapor through the needle. In some embodiments, tension wires attached to the needle can be pulled to change the shape of the needle or stabilize the needle to aid puncture. In some embodiments, pulling these tension wires may facilitate puncture or help to penetrate the needle into the prostate tissue.

[0377] Figure 11B Different embodiments of the needle described in this specification are shown. Reference Figure 11B Needles 3801c, 3801d, and 3801e are single needles with different curvatures. Needles 3801f and 3801g are double needles of different sizes. In some embodiments, needles 3801c, 3801d, 3801e, 3801f, and 3801g are covered by an outer heat insulation layer, which will then be... Figures 11K to 11Q As described in the text. Needles 3801f and 3801g show exemplary embodiments of two needles extending from a single port. In some embodiments, Figure 11B The needle is made of 22# stainless steel. Figure 11C This specification shows some embodiments of the use of dual needles (e.g.) Figure 11B An exemplary process for delivering ablative 3802 through a hollow opening 3804 at the edge of a pair of needles 3805, 3807 (double needle 3801f or 3801g).

[0378] Figure 11D Exemplary depths, or insertion depths, of needles 3801c, 3801d, and 3801e with different curvatures as described in some embodiments of this specification are shown. The depth increases with increasing curvature. In some embodiments, needles 3801c, 3801d, and 3801e have a curvature of 0°–150°, a diameter of 15–30#, and a length ranging from 0.2 cm to 5 cm for each needle. Figure 11E This specification shows some embodiments of the embodiments described relative to Figure 11D Exemplary depths or insertion depths of needles 3801c, 3801d, and 3801e, and needles 3801f and 3801g. Figure 11F Some embodiments described in this specification are shown. Figure 11EExemplary lengths of needles 3801c, 3801d, 3801e, 3801f, and 3801g are provided, extending in a straight line from the proximal end port 3803 to the furthest lateral point 3809 reached by the needle body.

[0379] Figure 11G Different views of a single-needle assembly 3806 extending from port 3808, as described in some embodiments of this specification, are shown. In some embodiments, port 3808 includes two cylindrical portions, a first portion 3808a and a second portion 3808b, wherein the second portion 3808b is connected to an inner catheter (e.g., Figure 1M The inner catheter 107m), and the first part 3808a is connected to the second part 3808b, and the distal edge of the first part 3808a provides an outlet for one or more needles (e.g., needle 3806). Additionally, Figure 11G A top view 3806A, a side view 3806B, and a front perspective view 3806C of the needle 3806 in its default bent state are shown. A side perspective view 3806D of the needle 3806 in its linearly contracted state is also shown. In one embodiment, the length of the needle 3806 extending along a straight line from the distal edge of the first portion 3808a to the farthest point of the needle 3806 is approximately 12 mm, and the depth along a straight line from the sharp edge of the needle 3806 to the port is approximately 12.3 mm. In some embodiments, the first portion 3808a of the port 3808 has a length of approximately 4.10 mm and a diameter of approximately 2.35 mm. In some embodiments, the second portion 3808b of the port 3808 has a length of approximately 4.30 mm and a diameter in the range of approximately 1.75 mm to 1.85 mm. Figure 11H Another horizontal view of the needle 3806 described in some embodiments of this specification shows one or more holes 3810 at the sharp edge of the needle 3806. In some embodiments, each hole 3810 for deploying ablation vapor extends approximately 3.50 mm in length on one side of the tip of the hollow cylindrical needle 3806. These holes are located along one side of the length of the needle 3806, while the distal tip of the needle 3806 is plugged. In some embodiments, the distal tip may be plugged with a plug 3811 made of a biocompatible material, such as stainless steel. In some embodiments, the distal tip is plugged, and vapor escapes from the side of the distal tip.

[0380] Figure 11I Different views of the dual-pin assembly 3812 extending from port 3814 as described in some embodiments of this specification are shown. Figure 11J Different views of another dual-pin assembly 3816 extending from port 3818, as described in some embodiments of this specification, are shown. Also refer to... Figure 11I and Figure 11JPorts 3814 and 3818 may include two cylindrical portions, namely first portions 3814a and 3818a and second portions 3814b and 3818b, wherein the second portions 3814b and 3818b are connected to the internal conduit (e.g., Figure 1M The inner catheter is 107m long, and the first parts 3814a and 3818a are connected to the second parts 3814b and 3818b, and the distal edges of the first parts 3814a and 3818a provide dual outlets for the dual-needle assemblies 3812 and 3816. The dual-needle assemblies include first needles 38121 and 38161 and second needles 38122 and 38162. Figure 11I and Figure 11J Top views 3812a and 3816a, side views 3812b and 3816b, and top perspective views 3812c and 3816c are shown for needles 3812 and 3816 in their default bent state. Side perspective views 3812d and 3816d are also shown for needles 3812 and 3816 in their linearly contracted state. Reference Figure 11I The length of needle 38121, extending along a straight line from the distal edge of port 3814 to its farthest point, is approximately 17 mm. The depth along a straight line from the sharp edge of needle 38121 to port 3814 is approximately 13.4 mm. The length along a straight line from the distal edge of port 3814 to the farthest point of needle 38122 is approximately 12 mm. The length along a straight line from the sharp edge of needle 38122 to port 3814 is approximately 12.2 mm. In this embodiment, the configuration of port 3814 is similar to that of port 3808. The distance between the sharp edges of needles 38121 and 38122 is approximately 5 mm. (Reference) Figure 11J The length of needle 38161 extending along a straight line from the distal edge of port 3818 to the farthest point of needle 38161 is approximately 22 mm, and the length along a straight line from the sharp edge of needle 38161 to port 3818 is approximately 13.4 mm. The length of needle 38162 extending along a straight line from the distal edge of port 3818 to the farthest point of needle 38162 is approximately 12 mm, and the length along a straight line from the sharp edge of needle to port 3818 is approximately 12.2 mm. In an embodiment, port 3818 is arranged similarly to port 3808. The distance between the sharp edges of needles 38161 and 38162 is approximately 10 mm. In some embodiments, one or both of needles 38161 and 38162 have one or more openings or holes 3817 along their own length on their sides, and the distal tips of one or both needles 38161 and 38162 with holes 3817 are plugged with plugs 3819. Hole 3817 provides an outlet for the ablation steam.

[0381] Figure 11KThe diagram shows a heat insulation layer 1122 on a single-needle structure 1112 including needle 1114 and a double-needle structure 1116 including needles 1118 and 1120. Each of the needles 1114, 118, and 1120 may have one or more openings, such as an opening 1124 at the tip of needle 1114, to provide an outlet for vapor during ablation. The heat insulation layer 1122 insulates a portion of the outer length of needles 1114, 118, and 1120. In some embodiments, the heat insulation layer 1122 may be added as a shrink tube or a spray. In various embodiments, the heat insulation layer 1122 extends along any portion of the length of needles 1114, 118, and 1120 from their distal tip to their root, but does not cover any openings at the distal tip or along the length of the needle. The ablation band can be modified by varying the distribution of the heat insulation layer 1122 on the needles. See details [link to details]. Figure 11L , 11M The explanation was provided for 11N.

[0382] Figure 11L This specification illustrates a single-needle structure 1114 having a heat insulation layer 1122 located within prostate tissue 1126, as described in some embodiments. The heat insulation layer 1122 covers a portion of the length of the needle 1114 extending from the catheter 1124 to the tip, such that a portion of the heat insulation layer 1122 extends from the urethra 1128 into the prostate tissue, thereby protecting the urethra 1128. Figure 11M This specification illustrates a single-needle structure 1114 with a heat insulation layer 1122 located within a uterine fibroid 1130, as described in some embodiments. The needle 1114 extends from the uterus 1132 into the fibroid 1130. Relative to... Figure 11L As shown, the heat insulation layer 1122 covers a larger portion of the needle 1114, such that the heat insulation layer 1122, together with a small portion of the tip of the needle 1114, extends into the myoma 1130 and delivers ablation vapor only to the myoma 1130 while protecting the anatomical portion of the myoma's exterior. Figure 11N The dual-needle structure 1116 described in some embodiments of this specification is shown, wherein two needles 1118, 1120 are inserted into separate prostatic lobes 1134, 1136. A heat insulation layer 1122 covering the needles 1118, 1120 extends into the lobes 1134, 1136 together with the non-heat-insulated distal ends of the needles.

[0383] Figure 11OExemplary embodiments of the manipulable catheter shaft 1138 described in some embodiments of this specification are shown. The catheter shaft 1138 has a flexible configuration that allows it to be manipulated by a user to point the needle 1114 in a desired direction. Referring to the figure, arrow 1140 indicates the ability to manipulate the needle in different directions using the catheter shaft 1138. In an embodiment, an observation device 1142 is configured at the tip of the catheter shaft 1138 at the base of the needle 1114 to help the user clearly observe the needle 1114. In an embodiment, the observation device 1142 includes a camera, lens, LED, or any other device to facilitate direct observation of the position and movement of the needle 1114 within the patient's anatomy, thereby assisting the physician in manipulating the needle 1114. In an embodiment, a channel 1144 in the catheter shaft 1138 is used to receive optical and electrical wires connecting the observation device 1142 to a controller (e.g., controller 15q) for power supply and display of captured images on a screen or split screen to facilitate observation of the ablation band and control of ablation agent delivery. In some other embodiments, the observation device 1142 is connected to a peripheral computing and / or imaging device (e.g., an iPhone) to display images captured by its camera. In one embodiment, the controller of the observation device 1142 is disposed in the handle of the guide shaft 1138. In one embodiment, the needle is manipulated using multiple tension lines connected to it, and the position or orientation of the needle tip is manipulated by pulling these tension lines.

[0384] Figure 11P The figure shows a needle 1114 with an open tip 1146 as described in some embodiments of this specification. The figure also shows steam 1148 ejected from the opening at the distal tip 1146. In practice, the needle 1114 is first rinsed with water to remove any air before spraying the ablative steam or vapor 1148. Figure 11Q Another embodiment of the needle 1114 according to the invention is shown, which has a plug 1150 at its distal end to block the tip, and includes a hole or opening 1149 adjacent to the tip along the uninsulated length of the needle 1114 for providing a spray-type vapor spray 1148.

[0385] Figure 12 This is an illustration of transurethral prostate ablation performed on an enlarged prostate 3901 in the male urinary system using an ablation device that utilizes a deformable needle, as described in one embodiment of this specification. Figure 12The diagram also depicts a bladder 3902 and a prostatic urethra 3903. An ablation catheter 3923, having a handle 3920 and a positioning member 3928, is inserted into the urethra 3903 and advanced into the bladder 3902. In one embodiment, the positioning member 3928 is inflated and pulled to the junction of the bladder and urethra, thereby positioning the needle 3907a at a predetermined distance from the junction. Using a pusher (not shown) connected to the handle 3920, the needle 3907a is then pushed out of the catheter 3923 at any angle between 10° and 90°, through the urethra 3903 into the prostate 3901. Steam is delivered through a port (not shown), through the axis of the catheter 3923, and exits into the prostate tissue through an opening 3937 in the needle 3907a, thereby ablating the prostate tissue. According to one embodiment, the needle is heated after steam delivery, and while steam is being delivered, the needle changes from a generally straight shape 3907a to a curved shape 3907b. When steam delivery ceases, the needle returns to its original straight shape, facilitating retraction into the catheter. This mechanical change in needle shape allows for more efficient distribution of ablation energy within the prostate tissue. In this embodiment, steam is generated in the catheter handle 3920 or body 3923 using induction heating or resistance heating.

[0386] Figure 13A This is an illustration of one embodiment of the positioning member 4001 of an ablation catheter 4070, wherein a needle 4073 is connected to the catheter body. In different embodiments, the positioning member 4001 is an inflatable balloon. The positioning member or balloon 4001 is inflated to a first volume, thereby positioning the needle 4073 at a predetermined distance from the bladder neck 4050 and bringing the needle into contact with the target tissue. In one embodiment, an ablation agent such as steam or vapor is delivered to the target tissue through the catheter 4070. Through the axis 4071 of the catheter, the vapor exits from an opening (not shown) in the needle 4073 and enters the prostate tissue, thereby ablating the prostate tissue. In one embodiment, the balloon 4001 is capable of inflating to different sizes. In one embodiment, this feature is used to progressively or sequentially inflate the balloon 4001 to different sizes, thereby positioning the needle at different fixed distances 4051, 4052 from the bladder neck 4050, achieving treatment of discrete areas of prostate tissue. In one embodiment, the balloon can be used to place the needle at a predetermined distance of 1 mm to 50 mm from the bladder neck. In one embodiment, the positioning member 4001 is movable relative to the needle 4073, adjusting the distance between the needle and the positioning member 4073 within 1 mm to 50 mm. In another embodiment, the positioning member 4001 is calibrated to match the length of the needle 4073, using mechanical force to assist the needle in piercing the target tissue.

[0387] exist Figure 13BIn another embodiment shown, multiple inflatable balloons 4011, 4012, and 4013 are used as positioning components. These balloons can be used to position the needle 4083 at different fixed distances 4061, 4062 from the bladder neck 4060, achieving treatment of discrete areas of prostate tissue. It can be seen that any one of the multiple balloons can be inflated depending on the area of ​​tissue to be ablated. The balloons can also be ablated sequentially to allow complete coverage of the target tissue. In one embodiment, the number of balloons is one to five.

[0388] Figure 13C The diagram shows a cross-section of the distal tip of the catheter 4091 according to one embodiment of this specification. In one embodiment, for ablation of prostate tissue, the catheter used has an inner diameter (ID) of approximately 4 mm and an outer diameter (OD) of approximately 6 mm. Multiple thermally conductive elements 4090, such as needles, extend from the catheter 4091 at an angle of 30°–90°. In one embodiment, the needles can be retracted into the catheter after ablation.

[0389] In one embodiment, the balloon is inflated before ablation. In another embodiment, an ablative agent, such as steam or vapor, also transfers heat and contributes to balloon inflation. That is, the heat from the ablative agent is transferred from the lumen of the catheter to the air in the balloon, further increasing the balloon's volume and pushing the needle further into the target tissue. In yet another embodiment, the balloon is inflated by filling it with coolant supplied through a coolant port at the proximal end of the catheter. During use, the balloon is inflated by the coolant as steam or vapor is delivered through multiple needles. As the needles pierce the target tissue during use, the steam or vapor delivered through the piercing needles ablates tissue located deep within the target tissue. The inflated balloon, filled with coolant, contacts the surface of the target tissue and stabilizes the ambient temperature on the target tissue surface at a desired level, for example, below 60°C in some embodiments. This allows the steam to ablate deeper tissue without ablating surface tissue.

[0390] Figure 14 An embodiment of the handle mechanism 4100 is shown, which can be used to deploy and retract the needle at different insertion depths when ablating prostate tissue. (See reference...) Figure 14In one embodiment, the handle mechanism 4100 resembles a handheld gun or pistol, facilitating manipulation by a physician to treat prostate tissue. The tip 4101 of the handle is equipped with a groove into which an ablation catheter 4102 can be inserted to penetrate the patient's urethra. As described in the above embodiments, the ablation needle is coupled to the catheter and used to deliver steam or vapor to the target tissue. A mark 4103 is placed on top of the handle mechanism 4100, indicating the insertion depth of the needle. The mark can be set by printing, etching, painting, engraving, or by utilizing any other means known in the art for this purpose. In one embodiment, the ablation needle can be inserted or retracted in fixed distance increments (e.g., 5 mm), and the mark is accordingly set to reflect this increment. A button 4105 is provided on the mark, which advances or retracts a mark whenever the catheter and needle advance or retract a preset distance. In one embodiment, a trigger 4104 is provided on the handle mechanism, which can be pressed to advance the needle by a preset distance increment. In one embodiment, once the needle has been advanced to the maximum distance by repeatedly pressing the trigger, as indicated by button 4105 on the label, further pressing the trigger causes the needle to retract by an increment of distance. It can be noted that, as described in the above embodiments, the catheter is also equipped with a positioning element, such as a balloon, which prevents the catheter and needle from advancing beyond a fixed distance in the urethra.

[0391] In one embodiment, a knob or button 4106 is provided that can be rotated or pressed to control the direction of movement of the catheter and needle. That is, whenever the trigger 4104 is pressed, the knob 4106 can be used to determine whether the catheter and needle move forward (advance) or backward (retract).

[0392] In one embodiment, the handle mechanism 4100 further includes a heating chamber 4110 for generating steam or vapor to supply the conduit 4102. The heating chamber 4110 includes a metal coil 4112 wound around a ferromagnetic core. The chamber is filled with water through an inlet 4111 located at the proximal end of the handle mechanism 4100. In one embodiment, sterile water is supplied from a water source to the handle for conversion into steam. The handle is also equipped with an electrical connection 4108 to supply current from a current generator to the coil 4112. Applying alternating current to the coil 4112 generates a magnetic field that induces a current in the ferromagnetic core. This results in heating of the chamber 4110 and evaporation of the water therein. The steam or vapor generated in the chamber 4110 is delivered through a needle positioned in place to ablate target tissue.

[0393] In one embodiment, a start / stop button 4107 is also provided on the handle mechanism 4100 to start or stop ablation treatment as needed.

[0394] The same functionality can be achieved by other handle shape factors known in the art and also described in this application.

[0395] Figure 15A This is a flowchart illustrating a prostate tissue ablation method according to one embodiment of this specification. (Reference) Figure 15A The first step 4201 includes inserting a catheter of the ablation device into the patient's urethra, wherein the catheter includes a hollow shaft through which the ablation agent can pass, at least one first positioning member, at least one second positioning member located at a distal end of the at least one first positioning member, at least one input port for receiving the ablation agent, and a plurality of needles on the catheter located between the first and second positioning members, the needles being configured to deliver the ablation agent to prostate tissue. In one embodiment, the ablation device includes a controller including a microprocessor for controlling the delivery of the ablation agent. The catheter passes through the urethra such that the first positioning member is adjacent to the prostate tissue to be ablated, while the second positioning member is located at or away from the prostate tissue to be ablated. In step 4202, the positioning member is deployed to contact the urethra, and the catheter is positioned within the urethra, adjacent to the prostate tissue to be ablated. In step 4203, the plurality of needles pass through the urethra into the prostate tissue to be ablated. Finally, in step 4204, the ablation agent is delivered through the needles to ablate the prostate tissue. Optionally, in step 4205, sensors are used to measure parameters of the prostate, and in step 4206, this measurement is used to increase or decrease the flow rate of the ablation agent being delivered. Optionally, in one embodiment, a cystoscope is first inserted into the patient's urethra, and a catheter is inserted through the cystoscope. In some embodiments, one or more positioning members are filled with heat-insulating or cooling fluid to insulate or cool the bladder neck or prostatic urethra.

[0396] Figure 15B This is a flowchart illustrating a prostate tissue ablation method according to one embodiment of this specification. (Reference) Figure 15BThe first step 4211 includes inserting a catheter into the patient's urethra, wherein the catheter includes an ablation agent-permeable hollow shaft, at least one first positioning member, at least one second positioning member located at a distal end of the at least one first positioning member, at least one input port for receiving the ablation agent, and multiple needles on the catheter located between the first and second positioning members, these needles being configured to deliver the ablation agent to prostate tissue. In one embodiment, the ablation device includes a controller including a microprocessor for controlling the delivery of the ablation agent. The catheter passes through the urethra such that the first positioning member is adjacent to the prostate tissue to be ablated, while the second positioning member is located within the patient's bladder. In step 4212, the second positioning member is deployed and the catheter is pulled back such that the second positioning member is adjacent to the urethral orifice at the bladder neck. In step 4213, the first positioning member is deployed such that the catheter is located within the urethra and adjacent to the prostate tissue to be ablated. In the next step 4214, the multiple needles pass through the urethra into the prostate tissue to be ablated. Finally, in step 4215, the ablation agent is delivered through the needles to ablate the prostate tissue. Optionally, in one embodiment, a cystoscope is first inserted into the patient's urethra, and a catheter is inserted through the cystoscope. In different embodiments, the deployment order of the positioning components may be reversed. In other embodiments, only one of the two positioning components may be deployed for treatment.

[0397] Figures 15C-15E This illustration shows one embodiment of the use of an expandable catheter 1500 to dilate / widen a constricted prostatic urethra 1538, as described in some embodiments of this specification. The prostatic urethra 1538 constricts due to the enlargement of the prostate 1530. (See reference...) Figure 15C A compressible catheter 1500 with an expandable member 1525 is inserted into the prostatic urethra 1538. In an embodiment, the expandable member 1525 includes an expandable balloon or a self-expanding balloon. In an embodiment, the expandable member 1525 is covered, for example, by a semi-permeable sheath. In other embodiments, the expandable member 1525 is not covered. In an embodiment, the expandable catheter 1500 includes a central column 1537. One or more rows of central columns 1533 are provided, each row including multiple openings for delivering ablative agent. In an embodiment, the multiple openings are arranged in a specific opening structure, the shape, diameter, and number of which are not fixed to adjust the distribution of the ablative agent. (See reference...) Figure 15D The expandable member 1525 on the catheter 1500 expands and presses against the urethral wall 1539, which in turn presses against the prostate 1530. Then, an ablative agent 1541, such as steam, is delivered into the prostate tissue through multiple openings. (See reference...) Figure 15E The catheter 1500 was removed from the urethra 1538, leaving the widened prostatic urethra 1538. Figure 15FThe diagram shows an expandable, inflatable member 1525 of the catheter 1500, and an exemplary use of one or more needles 1550 to deliver an ablative agent 1541, such as steam or vapor, through a hollow outlet at the edge of the needle 1550. The needle extends from the central post 1537 of the catheter 1500, passes through the urethral wall 1539, and enters the prostate 1530 to deliver the ablative agent 1541 to the prostate tissue. Although... Figure 15F The illustration depicts the placement of component 1525 into the prostate; however, the same arrangement can be used for benign prostatic hyperplasia (BPH) and urethral stricture. In an embodiment, needle 1550 is used for... Figures 11A-11J One or more needles are shown and described in the context of [the preceding text]. In some embodiments, the expandable member 1525 is a wire mesh scaffold that can be subsequently removed. In another embodiment, the expandable member 1525 is made of a bioabsorbable material and is reabsorbed after a predetermined time. In some embodiments, the expandable member 1525 has a restraint and / or removal mechanism attached thereto for subsequent removal. In some embodiments, the restraint and / or removal mechanism is PTFE, ePTFE, or thread. In some embodiments, the expandable member includes an extracellular matrix to aid in proper healing following prostatic urethral ablation.

[0398] Middle lobe hyperplasia is a benign condition in which the middle lobe of the prostate enlarges and compresses into the base of the bladder, causing a ball valve-type obstruction at the bladder neck. Ideally, ablation therapy should be performed via the cystic duct rather than the urethra to access the middle lobe, especially the most affected portion. Accessing the middle lobe of the prostate via the bladder, rather than the urethra, has the advantage of avoiding urethral ablation damage and subsequent urethral stricture. Figure 15G An ablation catheter 1560 according to one embodiment of this specification is shown for ablation of prostate tissue in a patient with median lobe hyperplasia via a transcystic duct approach. Figure 15H An ablation catheter described according to another embodiment of this specification is shown, used for ablation of prostate tissue in a patient with median lobe hyperplasia via a transcystic duct approach. Figure 15G In one embodiment, the conduit 1560 includes at least one curved vapor delivery needle 1561 extending at its distal end. Figure 15H In one embodiment, the conduit 1565 includes at least one straight vapor delivery needle 1566 extending at its distal end. One or more needles, and their combination and deployment methods, may be similar to embodiments of other needles discussed in this specification. See also... Figure 15G and 15HThe catheters 1560 / 1565 are depicted as being inserted into and passing through the patient's spongy or penile urethra 1571, through the prostatic urethra 1572, and into the patient's bladder 1573. In an embodiment, the distal end of the catheter 1560 / 1565 is advanced to be positioned just beyond the bladder neck 1574 and within the bladder 1573, just past the internal urethral orifice 1576 (the opening of the bladder to the prostatic urethra) into the bladder 1573. At least one needle 1561 / 1566 extends from the distal end of the catheter 1560 / 1565 into the lumen of the bladder 1573, through the bladder wall 1577, and then into the median lobe 1575. An ablative in the form of vapor or steam is delivered through at least one needle 1561 / 1566 to ablate the tissue of the median lobe 1575. In some embodiments, catheters 1560 / 1565 optionally include at least one positioning member 1562 / 1564 configured to position the catheter within the bladder 1573 and stabilize the needle 1561 / 1566 to facilitate penetration of the median lobe 1575. In various embodiments, the positioning member 1562 / 1564 comprises a shape memory material configured between a first contractile structure for delivery and a second expansion structure for positioning. In various embodiments, the positioning member 1562 / 1564 in the second expansion structure has a disc, cone, hood, oval, elliptical, square, rectangular, or flower shape. In various embodiments, a tension line attached to the needle can be used to manipulate the needle and facilitate insertion into the prostate.

[0399] Figure 15I This is a flowchart illustrating one embodiment of this specification, outlining the steps of a method for ablating prostate tissue in a patient with median lobe hyperplasia using an ablation catheter via a transcystic duct approach. In step 1580, an ablation catheter (including at least one needle) is inserted into the patient's spongy urethra via the prostatic urethra, with the distal end of the catheter positioned within the patient's bladder. Optionally, the ablation catheter further includes at least one positioning member configured to position the catheter within the bladder and stabilize at least one needle penetrating the median lobe. Optionally, in step 1581, the positioning member is deployed to place the catheter into the bladder, stabilizing at least one needle. In step 1582, at least one needle is extended from the distal end of the catheter through the bladder or bladder neck wall into the patient's median lobe of the prostate. In step 1583, an ablation agent is delivered into the median lobe through the at least one needle, ablating the prostate tissue. In this embodiment, the ablation catheter is part of an ablation system including a controller and means for generating the ablation agent. In step 1584, the flow rate of the ablative is controlled by a controller to stabilize the pressure in the bladder and middle lobe below 5 atm.

[0400] In various embodiments, the ablation treatment provided by the vapor ablation system of this specification achieves the following therapeutic endpoints of prostate ablation: stabilizing tissue temperature below 100°C; increasing urine flow by at least 5% relative to pre-treatment flow rate at a 6-month follow-up; reducing prostate volume by at least 5% relative to pre-treatment volume at a 6-month follow-up; reducing post-void residue by more than 5% at a 6-month follow-up; reducing the incidence of acute urinary retention by 5% at a 12-month follow-up; decreasing prostate-specific antigen (PSA) by 5% at a 6-month follow-up; improving the American Urological Association (AURA) Symptom Index by more than 5% at a 6-month follow-up; ablating prostate tissue without peripherally ablating urethral tissue; and improving the International Prostate Symptom Score (IPSS) by at least 5% relative to the pre-treatment score, wherein... Figure 16A The IPSS questionnaire shown includes a series of 4380 questions about the patient's urination habits, with each question having a numerical score of 4381; the goal is to improve the BPHIIQ score by at least 10% compared to the pre-treatment Benign Prostatic Hyperplasia Impact Index (BPHIIQ) score, whereby... Figure 16B The BPHIIQ shown includes a series of questions 4385 about the patient's urinary problems, with each question having a numerical score of 4386; and a patient satisfaction rate of over 25% for the ablation procedure.

[0401] Endometrial ablation

[0402] Figure 17A The typical anatomy of the female uterus 1706 and fallopian tubes 1700 is shown. Figure 17B The location of the uterus and surrounding anatomical structures in a woman's body is shown at 1700. Figure 18A An exemplary ablation catheter 1802 arrangement for ablation of the uterus 1706 as described in some embodiments of this specification is shown. See also... Figure 17A and Figure 18AIn one embodiment, a coaxial catheter 1802 is inserted into the patient's vagina 1702 and advanced toward the cervix 1704. The catheter 1802 includes an outer catheter 1804 and an inner catheter 1806. The inner catheter 1806 is concentric with the outer catheter 1804 and has a smaller radius compared to the outer catheter 1804. An electrode 1808 for heating the catheter tip is located between two positioning members 1810 / 1812. In some embodiments, the electrode 1808 is adjacent to the proximal positioning member 1810. In some embodiments, the positioning members are discs—a proximal disc 1810 and a distal disc 1812. For the purposes of this specification, the discs 1810 / 1812 may also be referred to as shields 1810 / 1812. In some embodiments, the distal shield 1812 has a smaller diameter than the proximal shield 1810. In some embodiments, the distal shield 1812 is approximately 5 mm smaller than the proximal shield 1810. In one embodiment, the shields 1810 / 1812 are made of wires with different stiffnesses. The distal shield 1812 is configured to contact the fundus of the uterus 1706 and, like scaffolding, push the two halves of the uterus apart. The proximal shield 1810 is configured to close the internal os of the cervix 1708.

[0403] Figure 19A , 19B Figures 19C and 19C show different types of structures 1901, 1903, and 1905 for the distal and proximal discs 1812 / 1810, which can be utilized according to embodiments of this specification. These discs vary in stiffness and size, and can be selected by a physician based on indications for treatment. In some embodiments, the discs are conical with a diameter ranging from 5 mm to 50 mm. In some embodiments, the positioning member is an oval cone with a first proximal end diameter smaller than the second distal end diameter, thereby forming a shape or size approximating the uterine cavity. In different embodiments, the first positioning member may have a different shape or size than the second positioning member. One or more positioning members may be used to achieve the therapeutic purpose.

[0404] In some embodiments, the discs 1812 / 1810 are formed of wires made of one or a combination of polymers and metals, such as, but not limited to, polyetheretherketone (PEEK) and nickel-titanium (NiTi). In some embodiments, the wires are coated with an elastomer such as PU and / or silicone in different structures. Various units in the discs 1812 / 1810 may be covered or uncovered based on the function of the cover (e.g., whether it is used for sealing, ventilation, or any other purpose). In embodiments where the positioning members 1812 / 1810 are made of a NiTi wire mesh, the wire diameter ranges from 0.16 mm to 0.18 mm. In some embodiments, for the distal positioning member 1812, the wire mesh is coated with silicone, but excluding the area between the wires in the mesh, thus allowing vapor to escape / discharge from the space between the wires. In some embodiments, for the proximal positioning member 1810, the space between the wires is covered with silicone.

[0405] In one embodiment, the inner catheter 1806 is removable into and out of the outer catheter 1804 such that the outer catheter 1804 covers the inner catheter 1806 and restricts the positioning members 1810 / 1812 before insertion into the patient's uterus. The positioning members 1810 / 1812 are made of a shape memory material such that once the inner catheter 1806 extends beyond the distal end of the outer catheter 1804, the positioning members expand into an unfolded structure, such as... Figure 18A As shown.

[0406] In one embodiment, catheter 1802 is inserted into vagina 1702 such that the distal end of outer catheter 1804 is adjacent to internal orifice 1708, wherein inner catheter 1806 is disposed within outer catheter 1804, and positioning members 1810 / 1812 are in a first confined configuration. The inner catheter is then advanced into uterus 1706. Catheter 1802 is advanced until distal disc 1812 is located within uterus 1706, and proximal disc 1810 occludes uterus 1706 by its proximity to internal orifice 1708. In one embodiment, catheter 1802 includes a cervical support 1803 connected to outer catheter 1804. As catheter 1802 unfolds in the patient's uterus, cervical support 1803 abuts against external orifice and helps stabilize catheter 1802 in the correct position. When catheter 1802 is deployed, the distal portion 1804c of the outer catheter 1804 is positioned within the cervix or cervical canal, extending from the cervical support 1803 to a point adjacent to the proximal positioning member 1810. In embodiments, the distal positioning member 1812 and the proximal positioning member 1810 move separately or expand and lock together. In embodiments, the insertion length of the inner catheter 1806 is used to measure uterine depth and determine the amount of vapor ablation to be utilized in order to stabilize the pressure within the uterus 1706 below a predetermined threshold. Vapor ports 1814 are located on the inner catheter 1806 between the distal disc 1812 and the proximal disc 1810 to output vapor for ablation. Multiple vapor ports are arranged circumferentially around the length of the catheter. The size, shape, or port density (number of ports / catheter length) of the vapor ports are variable to optimize the delivery of vapor into the uterine cavity. Steam 1809 heats the endometrium near the distal disc 1812 and then travels toward the proximal disc 1810, simultaneously expelling air from the endometrium. In another embodiment, the steam delivery port is configured to simultaneously and uniformly heat the entire endometrial cavity. In embodiments, at least one of the inner conduit 1806 or the outer conduit 1804 includes an venting member or groove 1816 that allows air to escape from the uterus 1706, thereby allowing endometrial air to escape and preventing overpressure of the endometrial cavity. In some embodiments, the groove may be formed along a portion of the total circumference of the inner conduit 1806 or the outer conduit 1804. In some embodiments, the groove may be formed along the total circumference of the inner conduit 1806 or the outer conduit 1804, more preferably, along 1% to 90% of the total circumference of the inner conduit 1806 or the outer conduit 1804. Figure 18BExemplary embodiments of the grooves 1816 configured in the wall of the inner catheter 1806 as described in some embodiments of this specification are shown. In some embodiments, an opening in the proximal disc 1810 allows the uterus 1706 to vent. In embodiments, the proximal disc 1810 is covered with an elastomeric material, such as PU or silicone, in a structure having various units or openings within the disc 1810, which are uncovered and allow ventilation during ablation. In other embodiments where sealing is required, there are no uncovered units or openings in the disc 1810 to allow ventilation. In embodiments, a pressure sensor 1822 is used with the catheter 1802 to check and subsequently maintain the pressure within the uterus 1706 below 50 mmHg, preferably below 30 mmHg, more preferably below 15 mmHg. In embodiments, the pressure is also stabilized at no more than 10% above atmospheric pressure. Because a low pressure level is maintained within the uterus, embodiments of this specification can omit integrity checks, which are time-consuming and risky and require implementation in the prior art. In one embodiment, the endometrial cavity pressure is measured by a generator by measuring the back pressure on the saline solution pushed onto the electrode through the inner catheter, and the endometrial cavity pressure can be regulated by adjusting the saline flow rate to maintain the endometrial cavity pressure below 5 atm. In some embodiments, the endometrial cavity pressure is stabilized at less than 0.5 atm.

[0407] Figure 18C This is the use described in some embodiments of this specification. Figure 18AA flowchart of a method for ablating endometrial tissue using a catheter. In step 1830, the catheter is inserted into the patient's uterus. In step 1832, contact or partial seal is created between the outer surface of the device and the uterine wall. Then, in step 1834, vapor is delivered through the catheter into the patient's uterus. In step 1836, the vapor condenses on the uterine tissue, wherein the partial seal is a temperature seal and ruptures once the temperature within the uterine seal exceeds >90°C, and wherein the partial seal is a pressure seal and ruptures once the pressure within the uterine seal exceeds 1.5 psi, preferably 1.0 psi, more preferably 0.5 psi. In another embodiment, the partial seal ruptures once the pressure within the uterine seal exceeds 2 psi or 10 mm Hg. In another embodiment, the partial seal ruptures when the pressure exceeds 6 psi or 30 mm Hg. In some embodiments, the partial seal is a pressure seal and ruptures once the temperature within the uterine seal exceeds 101°C and the pressure exceeds 0.5 psi. In some embodiments, the partial seal is a pressure seal, and the partial seal ruptures once the temperature within the uterine seal portion exceeds 102°C and the pressure exceeds 1.0 psi. In some embodiments, the partial seal is a pressure seal, and the partial seal ruptures once the temperature within the uterine seal portion exceeds 103°C and the pressure exceeds 1.5 psi.

[0408] Figures 18D-18G This specification shows the description Figure 1P An example of an 1800 system endometrial ablation catheter. (See reference) Figure 18DThe catheter 1800 has an outer catheter or sheath 1802a and an inner catheter 1806a. In some embodiments, the outer diameter of the inner catheter 1806a is approximately 3.5 mm. In some embodiments, the distal end 1811a of the catheter 1800 has a spherical tip 1813a to allow for non-invasive insertion into the patient's vagina, through the cervical canal 1704, and into the uterus 1706 without prior dilation of the cervix. Multiple rows 1814a, 1815a, 1818a, and 1821a are located between the distal positioning member 1812a and the proximal positioning member 1810a, each row having multiple steam delivery ports 1816a. In different embodiments, the number of ports 1816a is 1-10,000. In some embodiments, the number of ports 1816a is 64-96. In embodiments, the size of the orifice in each port 1816a ranges from 0.01 mm to 1 mm. In one embodiment, the orifice size is 0.1 mm. In different embodiments, the vapor delivery port 1816a has different sizes in different rows 1814a, 1815a, 1818a, 1821a, thereby creating a vapor gradient along the catheter and within the organ volume. For example, in some embodiments, larger delivery ports are located in the distal row 1814a to maximize vapor in a larger volume cavity, while smaller delivery ports are located in the proximal row 1821a for a smaller volume cavity. In embodiments, row 1815a includes ports smaller than those in row 1814a, while row 1818a includes ports smaller than those in 1815a but larger than those in 1821a. In other embodiments, the total surface area of ​​the ports in the distal rows 1814a, 1815a, or the distal half of the catheter 1800 is greater than the total surface area of ​​the ports in the proximal rows 1818a, 1821a, or the proximal half of the catheter 1800. In yet another embodiment, the port sizes remain consistent, while the port density varies in different rows or regions of the catheter.

[0409] refer to Figure 18E The catheter 1800 is advanced through the cervical canal 1704 into the uterus 1706, such that the inner catheter 1806a is located within the uterus 1706 and the outer sheath 1802a is located within the cervical canal 1704. The distal positioning member 1812a is then deployed. In embodiments, the positioning member 1812a may vary in size, shape, diameter, geometry, or any other structural features to adjust the vapor distribution in a desired manner. Reference Figure 18FIn one embodiment, a funnel-shaped distal positioning member 1812a is deployed, and a catheter 1800 is further advanced into the uterus 1706, such that the distal end of the external catheter 1804a is close to the internal os 1708. In another embodiment, a funnel-shaped proximal positioning member 1810a, which may or may not be ventilated, is also deployed. Additionally, an external cervical stabilizing member or cervical plinth 1803 is located at the external os 1703 of the cervix. (See reference) Figure 18G Vapor 1819a is delivered within row 1814a through multiple ports 1816a. In some embodiments, a region on the surface of the proximal positioning member 1810a provides ventilation of vapor or steam. In some embodiments, the proximal positioning member 1810a includes multiple openings 1817a to allow ventilation. In various embodiments, the proximal positioning member 1810a is covered by a gas-permeable membrane or a porous membrane to allow ventilation. In some embodiments, for the distal positioning member 1812, the mesh is coated with silicone, but the regions between the filaments in the mesh are not, thus allowing vapor to escape / discharge from these spaces between the filaments. In some embodiments, for the proximal positioning member 1810, the spaces between the filaments are covered with silicone.

[0410] In some embodiments, the proximal positioning member may be connected to the intermediate catheter and allow ventilation between the intermediate catheter and the inner catheter. In another embodiment, the proximal positioning member may be connected to the outer catheter and allow ventilation between the outer catheter and the inner catheter.

[0411] Figure 18H This is a flowchart illustrating the use of an ablation catheter to ablate the endometrium of a patient, as described in the embodiments of this specification, and lists the steps involved. In various embodiments, the catheter is similar to that in the reference... Figure 18D-18G Those described. In some embodiments, the method does not require pre-dilation of the cervix prior to ablation. At step 1840, the physician uses a ball-shaped tip (such as...) Figure 18D The bulbous tip 1813a) of the catheter 1800 is inserted into the patient's uterus through the cervix and propels the catheter further into the uterus. The bulbous tip helps guide the device through the cervix and allows for non-invasive insertion. In some embodiments, the bulbous tip includes... Figure 18O The olive-shaped connection 1882 described in the context is for non-invasive insertion. In some embodiments, at step 1842, an actuator (such as...) is used. Figure 1P The actuator 191p on the handle 190p pushes the ball-shaped tip forward. For example, see reference. Figure 1POn the back side of the handle, the sliding actuator 191p is moved forward to activate / push the ball tip forward. Once the catheter is advanced into the uterus, at step 1844, the first and second positioning members are deployed, and the distal positioning member is brought closer to the uterus. In some embodiments, as referenced... Figure 1P The described actuator deploys a positioning member. At step 1846, a second proximal positioning member is placed on the internal os of the cervix to create a partial obstruction, rather than a complete seal. (See reference...) Figure 18G As described, an area on the surface of the disc will provide ventilation to pressurized air or steam. In one embodiment, ventilation is performed through the neck of the positioning member. In another embodiment, ventilation is performed between the inner and intermediate catheters or between the inner and outer catheters. At step 1848, steam or vapor is delivered into the uterus through the plurality of steam delivery ports on the catheters to ablate the endometrium.

[0412] Figures 19D-19I The endometrial ablation catheter is shown at different stages of the exemplary method for deploying catheter 1802 as described in some embodiments of this specification. Figure 19D The catheter assembly 1802 having a handle 1902 and a cervical support 1904 is shown in some embodiments of this specification. Figure 19E The position of the cervical support 1904 is shown before the deployment of the catheter 1802. The cervical support is located outside the uterus 1706 and cervix 1704 at the external os. In the figure, the uterus 1706, cervix 1704 and cervical support 1904 are shown on the left, while the specific hand movement on the handle 1902 is shown on the right to demonstrate the deployment of the catheter 1802. Figure 19F Exemplary positions of hands 1990, 1991 are shown when deploying the proximal positioning member 1810 as described in some embodiments of this specification, holding the catheter 1802 and handle 1902. The user holds the outer sheath of the catheter 1802 with one hand 1990 while pushing the handle 1902 forward with the other hand 1991. Figure 19G The distal positioning member 1812 is shown to deploy when the user pushes the handle 1902 of the catheter 1802 to extend the inner catheter 1806 within the uterus 1706. Figure 19HThis specification illustrates the full deployment of the distal positioning member 1812, either uncoated or selectively coated with silicone, and the deployment of the proximal positioning member 1810, as described in some embodiments of this specification. Up to this point, nothing has been placed during the deployment of the catheter 1802. The user may decide to stop here, or adjust the position of the catheter 1802 until the achieved distance is just less than the length of the uterus 1706 to prevent perforation. In some embodiments, the user may decide to push the catheter 1802 until its distal positioning member 1812 abuts the bottom of the uterus, thus indicating resistance at the bottom. In some embodiments, the user may turn a dial provided on the handle 1902 clockwise to retract the proximal positioning member 1810 and further extend the distal positioning member 1812. In some embodiments, when the proximal positioning member 1810 is deployed, it moves toward the cervical support 1904, while the cervical support 1904 moves toward the proximal positioning member 1810 in the opposite direction (similar to Chinese cat's cradle). Figure 19I The diagram shows rotating the dial 1906 to further retract the first positioning member 1810 to partially seal the cervix, thereby isolating the uterus 1706. In some embodiments, the partial seal is not perfect (an overflow outlet is provided in the opening or hole of the proximal positioning member, or a venting member / groove is provided in one or both of the inner or outer catheter / sheath) to allow vapor to escape from the uterus, thereby maintaining low pressure. In some embodiments, the user ablates the uterus by delivering steam via catheter 1802 for a cycle of approximately 40 seconds. In embodiments, the proximal positioning member 1810 has a selective coating, and it provides a drainage tube to collect water generated during and after the condensation of the steam during ablation.

[0413] Figures 18I-18N An exemplary embodiment of the distal end of the endometrial ablation catheter with a single positioning member as described in this specification is shown. Figure 18I The accompanying images show a sectional side view 1854a, a side view 1854b, and a distal end front view 1856 of the endometrial ablation catheter 1802i described in some embodiments of this specification. The catheter 1802i is shown with a braided stent 1858. The stent 1858 serves as a positioning member as described with reference to the endometrial ablation catheter of this specification. In embodiments, the braided stent 1858 is made of nickel-titanium alloy wire mesh or any other shape memory material, such that the stent 1858 unfolds into a deployment structure, such as... Figure 18I As shown. In one embodiment, the support 1858 is made of a single wire mesh 1858a. In some embodiments, the support 1858 is made of a double wire mesh 1858b. Figure 18J Showing Figure 18IA perspective side view of the catheter, wherein a stent 1858 extends over an inner catheter 1806 and extends outward from an outer catheter 1804. Steam is deployed and released from the inner catheter 1806 while the braided stent 1858 is deployed in the uterus. The catheter includes a non-invasive distal tip 1859 with a guidewire lumen, such as a reference... Figure 18L-Figure 18N As described, the guidewire lumen can be large enough to accommodate a uterine probe. Figure 18K This specification shows a sectional view 1862, a perspective side view 1864, and a distal end front view 1860 of the braided support 1858 described in some embodiments. The conical proximal end of the positioning member is partially or completely covered by an insulating film made of silicone or PTFE.

[0414] Figure 18L This is a side perspective view of the non-traumatic tip 1859 of the distal end 1866 of the inner catheter 1806, which is used to connect to the endometrial ablation catheter as described in some embodiments of this specification. Figure 18M This image shows a lateral anterior perspective view of the non-traumatic tip 1859 of the distal end 1866 of the inner catheter connected to the endometrial ablation catheter as described in some embodiments of this specification. Figure 18N This image shows a top perspective view of the non-invasive tip 1859 of the distal end 1866 of the inner catheter connected to the endometrial ablation catheter, as described in some embodiments of this specification. Also referenced... Figure 18L , Figure 18M and Figure 18N The non-traumatic tip 1859 includes an opening 1868 for guidewire passage. In an embodiment, the opening 1868 accommodates a 0.035-inch guidewire. The non-traumatic tip 1859 is connected to the distal end 1866 of the inner catheter 1806. In some embodiments, the non-traumatic tip 1859 is connected to the distal end 1866 of the inner catheter 1806 via a threaded screw 1872. The non-traumatic tip 1859 is made of a soft plastic material and includes grooves for receiving the inner catheter 1806 and is locked to the inner catheter by the threaded screw 1872.

[0415] Figure 18OThis is a different view of a dual-positioning member ablation catheter 1802p with a non-invasive olive-shaped tip 1882, as described in another embodiment of this specification. The olive-shaped tip 1882 ensures that the uterus is not punctured and provides non-invasive insertion of the catheter 1802p. In some embodiments, the olive-shaped tip connection 1882 may include a hollow channel within its body, the channel opening at the distal edge of the connection 1882 to allow steam delivery through the channel. In some embodiments, one or more holes in the tip of the connection 1882 allow steam delivery. All holes may have similar or different diameters. Two positioning members, a proximal positioning member 1884 and a distal positioning member 1886, are provided with the catheter 1802p. Positioning members 1884 and 1886 are in the shape of a canopy, wherein the diameter of the distal canopy 1886 may range from 25 mm to 34 mm + / - 2 mm, and the diameter of the proximal canopy 1884 may range from 25 mm to 30 mm + / - 2 mm. The distance between the two shields 1884 and 1886 can be in the range of 28 mm to 36.4 mm. Each shield 1884 / 1886 can have a depth of approximately 5 mm along the length of the conduit 1802p. In an embodiment, each shield 1884 / 1886 is connected to the shaft 1888 using a flexible connection mechanism with PTFE wire. The distance between the distal end of the distal shield 1886 and the distal tip of the olive-shaped tip 1882 can be approximately 16.7 mm. The shaft portion 1888a extending between the distal shield 1886 and the olive-shaped tip connection 1882 may also include one or more orifices for distributing vapor during ablation. In some embodiments, orifices may also be present in front of the distal shield 1886, between the distal shield 1886 and the proximal shield 1884, for vapor propagation. The length of the olive-shaped tip 1882 can extend to approximately 6 mm. The diameter of the distal tip of the olive-shaped tip 1882 can be in the range of 3.4 mm + / - 0.05 mm. Steam enters the shaft 1888 of the conduit 1802p and exits along the shaft 1882 through the opening 1889 during ablation. The diameter of the shaft 1888 between the two caps 1884 and 1886 can be approximately 1.1 mm + / - 0.05 mm. In an embodiment, there are additional openings in the olive-shaped tip 1882 distal to the distal cap 1886 and in the conduit shaft 1888a. The shaft 1888a extending from the distal end of the distal cap 1886 to the olive-shaped tip 1882 can be made of a nickel-titanium alloy and has a diameter of approximately 0.4 mm.

[0416] Figure 18P The distal end of an ablation catheter 1878 having a distal positioning member 1879 and multiple ports 1877 along the length of the catheter axis 1875, as described in some embodiments of this specification, is shown. Figure 18QThis illustration shows the distal end of an ablation catheter 1891, as described in some embodiments of this specification, having a distal olive-shaped tip 1893 and a positioning member 1895, and a plurality of ports 1897 along the length of the catheter axis 1899. The olive-shaped tip 1893 is round and spherical and can be non-invasive to body tissue. A cross-sectional view of the olive-shaped tip 1893 shows an oblique opening or hole 1890 inside the tip tip 1893. In an embodiment, the olive-shaped tip 1893 has four identical and symmetrically arranged openings within its distal spherical tip. Each opening 1890 connects to and extends outward from the hollow catheter axis 1899, extending beyond the distal cover 1886. The opening 1890 provides an outlet for vapor to flow out distal to the positioning member 1895 during ablation. Figure 18R The image shows a side view of the distal end of an ablation catheter 1850 according to some embodiments of this specification, which has a distal olive-shaped tip 1857, a distal positioning member 1853, a proximal positioning member 1851 and a plurality of ports 1855 along the length of the catheter axis 1869. Figure 18S yes Figure 18R Rear perspective view of catheter 1850. Ablation catheter 1850 includes connector 1867 at its proximal end for connection to the proximal catheter portion.

[0417] Figure 18T The diagram illustrates the distal end of an ablation catheter 1802t, as described in some embodiments of this specification, having a semi-circular opening 1802c at its distal end and a distal positioning member 1896. While the figure shows a semi-circular opening 1802c, the opening may be of other shapes, such as, but not limited to, a semi-rectangular shape. In some embodiments, the positioning member 1896 is deformable, thus flattening when pushed against the floor of the uterus. The distal end 1894 of the catheter 1802t may be open or covered, but in either case includes a semi-circular opening 1802c. In some embodiments, the circular distal end of the shaft 1888 may include at least three equidistant semi-circular openings 1802c. In some embodiments, the distal end 1894 is closed with a cap 1849. In some embodiments, the cap 1849 has a diameter of approximately 1.65 mm. In some embodiments, the cap 1849 is welded to the distal end 1894. The cap 1849 is used to close the open distal end of the catheter 1802t, while the semi-circular opening 1802c still allows the opening for steam to exit and reach the floor of the uterus during ablation. In some embodiments, the ablation catheter 1802t does not include the cap 1849. In an embodiment, the shaft 1847 of the catheter 1802t includes a plurality of ports 1843 for delivering steam to other parts of the uterus.

[0418] Figure 18UThe distal end of an ablation catheter 18100a having a spherical distal positioning member 18106 and a cover plate 18112 extending over the entire or part of the positioning member 18106 is shown in an exemplary embodiment of this specification. Figure 18V The distal end of an ablation catheter 18100b having a spherical distal positioning member 18108, as described in another exemplary embodiment of this specification, is shown. Figure 18W The distal end of an ablation catheter 18100c having a tapered distal positioning member 18110, as described in yet another exemplary embodiment of this specification, is shown. Figure 18U , Figure 18V and Figure 18W Examples of this technology can be used in catheter devices for endometrial ablation and for bladder ablation (as described in subsequent figures). Also refer to... Figure 18U , Figure 18V and Figure 18W The distal tip 18102 of the catheter shaft extends into the positioning elements 18106, 18108, and 18110. The distal tip 18102 is an extension of the catheter shaft and may have a smooth, rounded tip at its distal end. In some alternative embodiments, the distal tip 18102 is flexible and may have a similar shape to... Figure 18T The distal tip 18102 is semi-circular. A portion of the distal tip 18102 has at least one or more openings 18104 to provide an outlet for vapor during ablation. In some embodiments, the openings 18104 are circular, grooved, semi-circular, or have any other shape. In some embodiments, 1 to 1000 openings 18104 are distributed over a length of 3 cm to 7 cm across the length and surface of the distal tip 18102, wherein the length or diameter of each opening ranges from 0.1 mm to 1 mm. In some embodiments, 64 to 96 openings are distributed on the distal tip 18102. In embodiments, the distal tip 18102 of the catheter is included within a positioning member, such as... Figure 18U 18106 spherical component Figure 18V spherical component 18108 or Figure 18W X is a 3D inverted cone-shaped wire mesh 18110. In embodiments, positioning members 18106, 18108, and 18110 are compressible or deformable upon contact with the fundus of the uterus or bladder. The tip of each positioning member 18106, 18108, and 18110 is free-floating, and the positioning members 18106, 18108, and 18110 are connected to the corresponding conduit at the proximal neck of the distal tip 18102. Thus, the positioning members 18106, 18108, and 18110 act as a "bumper" and are non-invasive to the fundus of the uterus, while also allowing steam distribution at the fundus. Each positioning member 18106, 18108, and 18110 is made of wire mesh, such that there is sufficient space between the wires of the mesh for steam to escape. Reference Figure 18U A cover plate 18112 is provided to partially cover the opening through the wire mesh on the proximal side (bottom) of the spherical positioning member 18106 to prevent steam from flowing in this direction. In some embodiments, the cover plate 18112 is silicone. Figure 18V An alternative embodiment of the spherical positioning member 18106 is shown, which is in the form of a spherical positioning member 18108 excluding the cover plate 18112. Figure 18W The use of the conical positioning member 18110 is shown, which resembles an inverted Ellenmeyer flask and is close to the shape of the uterus.

[0419] Figure 18X This specification illustrates a non-invasive, soft tip 18114 of a catheter shaft 18116 for insertion into the cervix 18118, as described in some embodiments of this specification. In some embodiments of this specification, the catheter shaft 18116 is inserted through and through a portion of the patient's cervix via the patient's vaginal canal 18115. During delivery, a distal shield 18120, an inner catheter shaft 18126, and a proximal shield 18122 are all disposed within the catheter shaft 18120 such that the soft tip 18114 includes the distal end of the catheter. The soft tip 18114 may be soft and non-invasive to the vaginal canal 18115, the external os of the cervix 18117, and the cervix 18118 during positioning. During deployment, the inner catheter shaft 18126 is extended from the catheter shaft 18116 through the cervix 18118 into the uterus 18124 such that the inner catheter shaft 18126 is located within the uterus 18124, close to the fibroid / tumor / lesion 18128 requiring ablation treatment. A distal shield 18120 is deployed near the base 18132 of the uterus 18124, and a proximal shield 18122 is deployed near the internal cervical os 18119 to securely position the inner catheter shaft 18126 within the uterus. Openings in the inner catheter shaft 18126 are then used to deliver steam or vapor 18130 to ablate the target area. In some embodiments, a 40-second cycle of steam ablation is delivered to the uterus. During ablation, the distal shield 18120 can be slightly pulled back to ensure complete coverage of the target area (including the base 18132 of the uterus). A non-invasive, soft tip 18114 ensures protection of the patient's body tissues during catheter insertion and posterior pullback of the distal shield 18120.

[0420] Figure 19JThe distal end of an ablation catheter 1910, having a proximal positioning member 1911 and a distal positioning member 1912, and having a plurality of ports 1913 along the length of the catheter axis 1914, is shown in some embodiments of this specification. In embodiments, the catheter 1910 includes a proximal connector 1916 for connecting the proximal positioning member 1911 and connecting the catheter 1910 to a proximal catheter portion, and a distal connector 1917 for connecting the distal positioning member 1912. In some embodiments, the positioning members 1911, 1912 have a tapered or circular shape. In some embodiments, the positioning members are connected via sutures or threads 1918.

[0421] Figure 19K The distal end of an ablation catheter 1920, as described in some embodiments of this specification, is shown. The catheter 1920 has a proximal positioning member 1921, a distal positioning member 1922, and a distal olive-shaped tip 1925, and a plurality of ports 1923 along the length of the catheter axis 1924. In some embodiments, the catheter 1920 includes a proximal connector 1926 having a threaded lead screw for connection to a proximal portion of the catheter.

[0422] Figure 19L This specification illustrates a connector 1930 for connecting a distal positioning member to the distal end of an ablation catheter, as described in some embodiments. In one embodiment, the connector 1930 has a flat distal end 1931 that coaxially mates with the distal portion of the ablation catheter and includes a plurality of openings 1932 for sutures or threads used to secure the distal positioning member. In another embodiment, the connector 1933 includes an opening at its distal end to allow vapor to escape and reach the fundus of the uterus.

[0423] Figure 19M Another connector 1935, as described in other embodiments of this specification, for connecting a distal positioning member to the distal end of an ablation catheter. In an embodiment, connector 1935 has a circular distal end 1936 that is non-invasive to body tissue, coaxially fits over the distal portion of the ablation catheter, and includes a plurality of openings 1937 for passage of sutures or threads for securing the distal positioning member.

[0424] Figure 19N This specification illustrates a connector 1940 for connecting a proximal positioning member to the distal end of an ablation catheter, as described in some embodiments. In one embodiment, the distal end of the connector 1940 includes a plurality of openings 1941 for sutures or wires for securing the proximal positioning member, and the proximal end 1942 of the connector is connectable to a portion of the proximal catheter.

[0425] Figure 19OAnother connector 1945, as described in other embodiments of this specification, for connecting the proximal positioning member to the distal end of the ablation catheter. In an embodiment, the distal end of connector 1945 includes a plurality of openings 1946 for sutures or wires for securing the proximal positioning member, and the proximal end 1947 of the connector can be connected to a portion of the proximal catheter.

[0426] Figure 19P The image shows the shaft 1950 of an ablation catheter with multiple ports 1951 as described in some embodiments of this specification. Ports 1951 allow vapor to be released from the shaft lumen 1952 into the uterus. In some embodiments, the ports 1951 are arranged in rows 1953.

[0427] Figure 20A This illustration shows the use of an ablation device to perform endometrial ablation in a woman's uterus as described in embodiments of this specification. A cross-section of the female reproductive tract is shown, including the vagina 2970, cervix 2971, uterus 2972, endometrium 2973, fallopian tubes 2974, ovaries 2975, and fundus 2976. A catheter 2977 of the ablation device is inserted into the uterus 2972 ​​through the cervix 2971 at the cervical os. In this embodiment, the catheter 2977 has two positioning members: a conical positioning member 2978 and a disc-shaped positioning member 2979. The positioning member 2978 is conical, with an insulating membrane partially or completely covering it. The conical member 2978 positions the catheter 2977 at the center of the cervix 2971, and the insulating membrane prevents heat or ablation agent from leaking from the cervix 2971 through the os 2971. A disc-shaped second positioning member 2979 is deployed near the fundus of the uterus 2976, thereby positioning the catheter 2977 in the center of the cavity. Ablation agent 2978a is passed through the infusion port 2977a for uniform delivery of the ablation agent 2977a into the uterine cavity. The predetermined length “l” of the ablation segment of the catheter and the diameter “d” of the positioning member 2979 allow estimation of the cavity size and are used to calculate the amount of thermal energy required to ablate the endometrial lining. In one embodiment, the positioning members 2978, 2979 also function to move endometrial tissue away from the infusion port 2977a on the catheter 2977 to allow delivery of the ablation agent. An optional temperature sensor 2907 deployed near the surface of the endometrium is used to control the delivery of the ablation agent 2978a. Optional topology mapping using multiple infrared, electromagnetic, acoustic, or radio frequency energy emitters can be used to define the size and shape of the cavity in patients with irregular or deformed uterine cavities due to conditions such as fibroids. Additionally, data from diagnostic tests can be used to determine the size, shape, or other characteristics of the uterine cavity. In one embodiment, the distal positioning member 2979 is also conical and partially or completely covered with an insulating film. Various shapes of the positioning members described in this application can be used in various combinations to achieve the desired therapeutic purpose.

[0428] In this embodiment, the ablative is a vapor or steam that contracts upon cooling. Compared to a cryoprotectant that expands upon contact with tissue or a hot fluid used in hydrothermal ablation that maintains a constant volume, vapor / steam becomes water with a smaller volume. In the case of both cryoprotectants and hot fluids, increased energy delivery is associated with an increased volume of ablative, which in turn necessitates a mechanism for removing the ablative, otherwise the healthcare provider would suffer complications such as perforation. However, vapor becomes water with a significantly smaller volume upon cooling; therefore, increased energy delivery is not associated with an increase in the volume of residual ablative, thereby eliminating the need for continued removal. This further reduces the risk of thermal leakage via the fallopian tube 2974 or cervix 2971, thereby reducing any risk of thermal damage to adjacent healthy tissue.

[0429] In one embodiment, the positioning connector must be located at a distance greater than 0.1 mm, preferably 1 mm, and more preferably 1 cm from the ablation area. In another embodiment, the positioning connector can be located within the ablated area, as long as it does not cover the effective surface area. For endometrial ablation, 100% of the tissue does not need to be ablated to achieve the desired therapeutic effect. Therefore, in some embodiments, the positioning member can contact and cover 5% or less of the endometrial surface area.

[0430] In one embodiment, the preferred distal positioning member is an uncovered mesh located near the central body region. In another embodiment, the preferred proximal positioning member is a covered mesh that is pulled into the cervix to center the device and block the cervix and / or internal os. Figure 19A , Figure 19B and Figure 19C Some embodiments of the positioning device are shown. One or more such positioning devices can help compensate for anatomical variations in the uterus. The distal positioning device is preferably elliptical, with its major axis between 0.1 mm and 10 cm (preferably 1 cm-5 cm) and its minor axis between 0.1 mm and 5 cm (preferably 0.5 cm-1 cm). The proximal positioning device is preferably circular, with its diameter between 0.1 mm and 10 cm, preferably 1 cm-5 cm.

[0431] In another embodiment, the catheter is a coaxial catheter comprising an outer catheter and an inner catheter, wherein, upon insertion, the distal end of the outer catheter engages and stops at the cervix, while the inner catheter extends into the uterus until its distal end contacts the floor of the uterus. Figure 18AAn exemplary embodiment of the catheter structure described in this specification is shown. The length of the inner catheter, already inserted into the uterus, is used to measure the length of the uterine cavity and determine the ablation dose to be used. The ablation agent is then delivered to the uterine cavity via at least one port on the inner catheter. In one embodiment, during treatment, the intracavitary pressure is maintained below 100 mm Hg and preferably below 30 mm Hg (not exceeding 10% above atmospheric pressure). In one embodiment, the coaxial catheter further includes a pressure sensor to measure the intracavitary pressure. In one embodiment, the coaxial catheter further includes a temperature sensor to measure the intracavitary temperature. In one embodiment, the ablation agent is vapor, and the vapor is released from the catheter at a pressure of less than 100 mm Hg and preferably below 30 mm Hg. In one embodiment, the vapor is delivered at a temperature between 90°C and 100°C. In another embodiment, the vapor is delivered at a temperature between 100°C and 110°C.

[0432] Figure 20B This specification illustrates a coaxial catheter 2920 for endometrial tissue ablation according to one embodiment. The coaxial catheter 2920 includes an inner catheter 2921 and an outer catheter 2922. In one embodiment, the inner catheter 2921 has one or more ports 2923 for delivering an ablation agent 2924. In one embodiment, the ablation agent is vapor. In one embodiment, the outer catheter 2922 has a plurality of fins 2925 to engage the cervix to prevent vapor from leaking from the uterus into the vagina. In one embodiment, the fins are made of silicone. The fins 2925 ensure that the cervix is ​​not completely sealed. In one embodiment, the fins 2925 are configured with a plurality of holes that introduce vapor leaking from the uterus into the lumen of the outer catheter 2922. In one embodiment, the outer catheter 2922 includes a Luer lock 2926 to prevent vapor leakage between the inner catheter 2921 and the outer catheter 2922. In one embodiment, the inner catheter 2921 includes a measuring mark 2927 to measure the insertion depth of the inner catheter 2921 beyond the tip of the outer catheter 2922. Optionally, in various embodiments, one or more sensors 2928 are incorporated into the inner catheter 2921 to measure intracavitary pressure or temperature.

[0433] Figure 20CThis is a flowchart illustrating the steps involved in endometrial tissue ablation using a coaxial ablation catheter. At step 2902, the coaxial catheter is inserted into the patient's vagina and advanced to the cervix. Then, at step 2904, the coaxial catheter is advanced until the fins of the outer catheter engage the cervix, effectively stopping further advancement at that point. Then, at step 2906, the inner catheter is advanced until its distal end contacts the fundus of the uterus. Then, at step 2908, the insertion depth is measured using measuring marks on the inner catheter, thereby determining the amount of ablation agent to be used during the procedure. At step 2910, the Luer lock is tightened to prevent any vapor leakage between the two catheters. Then, at step 2912, vapor is delivered into the uterus through the lumen of the inner catheter via a delivery port on the inner catheter to ablate the endometrial tissue.

[0434] Figure 20D A bifurcated coaxial catheter 2930 for endometrial tissue ablation according to one embodiment of this specification is shown. The catheter 2930 includes a first elongated shaft 2932 having a proximal end, a distal end, and a first lumen. The first lumen splits at the distal end to create a coaxial shaft 2933. The distal end of the first shaft 2932 also includes a first positioning member or cervical plug 2934 that obstructs the patient's cervix. The catheter 2930 bifurcates as it extends distally from the cervical plug 2934 to form a second catheter shaft 2935 and a third catheter shaft 2936. The second catheter shaft 2935 and the third catheter shaft 2936 each include a proximal end, a distal end, and a shaft body having one or more vapor delivery ports 2937. The second catheter shaft 2935 and the third catheter shaft 2936 each include a second lumen and a third lumen for delivering an ablation agent. The distal ends of the second catheter shaft 2935 and the third catheter shaft 2936 respectively include a second positioning member or fallopian tube plug 2938 and a third positioning member or fallopian tube plug 2939 designed to engage the patient's fallopian tube during the ablation procedure and prevent leakage of ablation energy. The fallopian tube plugs 2938 and 2939 also serve to position the second shaft 2935 and the third shaft 2936 within the wall or isthmus of the patient's fallopian tube, respectively. The second catheter shaft 2935 and the third catheter shaft 2936 are independently coaxially extendable, and the length of each shaft 2935 and 2936 is used to determine the size of the patient's endometrial cavity. The ablation agent 2940 travels through the first catheter shaft 2932, through both the second catheter shaft 2935 and the third catheter shaft 2936, exits from the vapor delivery port 2937, and enters the endometrial cavity to ablate the endometrial tissue.

[0435] Figure 20E This is one embodiment of the use described in this specification. Figure 20DA flowchart of the method for ablating endometrial tissue using an ablation catheter outlines the steps involved. At step 2943, a coaxial catheter is inserted into the patient's cervix, and the cervix is ​​engaged with a cervical plug. Then, at step 2944, the catheter is advanced until each fallopian tube plug is close to the fallopian tube opening. Then, at step 2945, each fallopian tube is engaged with a fallopian tube plug, and the dimensions of the endometrial cavity are measured. The measurement is based on the length of each catheter shaft that has been advanced. At step 2946, the measured dimensions are used to calculate the amount of ablation agent required to perform the ablation. Then, at step 2947, the calculated dose of ablation agent is delivered into the endometrial cavity through the catheter shaft to produce the desired endometrial ablation.

[0436] Figure 20F This specification illustrates a bifurcated coaxial catheter 2950 with deployable members 2951, 2953 for endometrial tissue ablation, as described in one embodiment. Similar to... Figure 20D The catheter 2930, Figure 20F The catheter 2950 depicted includes a first elongated coaxial shaft 2952 having a proximal end, a distal end, and a first lumen. The first lumen splits at the distal end to create a coaxial shaft 2949. The distal end of the first shaft 2952 also includes a first positioning member or cervical plug 2954 that obstructs the patient's cervix. The catheter 2950 bifurcates as it extends distally from the cervical plug 2954 to form a second catheter shaft 2955 and a third catheter shaft 2956. The second catheter shaft 2955 and the third catheter shaft 2956 each include a proximal end, a distal end, and a catheter shaft body having one or more vapor delivery ports 2957. The second catheter shaft 2955 and the third catheter shaft 2956 each include a second lumen and a third lumen for delivering an ablation agent. The distal ends of the second catheter shaft 2955 and the third catheter shaft 2956 respectively include a second positioning member or fallopian tube plug 2958 and a third positioning member or fallopian tube plug 2959 designed to engage the patient's fallopian tube during ablation therapy and prevent leakage of ablation energy. Fallopian tube plugs 2958 and 2959 are also used to position the second shaft 2955 and the third shaft 2956 within the wall or isthmus of the patient's fallopian tube, respectively. The second catheter shaft 2955 and the third catheter shaft 2956 are independently coaxially extendable, and the length of each catheter shaft 2955 and 2956 is used to determine the size of the patient's endometrial cavity.

[0437] The catheter 2950 further includes a first inflatable element or balloon 2951 and a second inflatable element or balloon 2953 comprising a coaxial balloon structure. In one embodiment, the first balloon 2951 is a compliant balloon structure, and the second balloon 2953 is a non-compliant balloon structure shaped to approximate the shape, size, or volume of the uterine cavity. In another embodiment, the second balloon 2953 is partially compliant. In yet another embodiment, the compliance of the two balloons 2951, 2953 is substantially equivalent. Balloons 2951, 2953 are connected to the second catheter axis 2955 and the third catheter axis 2956 along the inner surface of each axis 2955, 2956. The first inner balloon 2951 is located within the second outer balloon 2953. The inner balloon 2951 is designed to be inflated with air, and a first volume of the inner balloon 2951 is used to measure the size of the patient's endometrial cavity. Ablation agent 2961 is introduced into the proximal end of catheter 2950 and travels through the first catheter shaft 2952 and into the second catheter shaft 2955 and the third catheter shaft 2956. The second catheter shaft 2955 and the third catheter shaft 2956 are designed to release ablation energy 2962 into the space 2960 between the two balloons 2951, 2953 through delivery port 2957. A portion of the ablation energy 2963 is transferred to air in the inner balloon 2951, causing its volume to expand from the first volume to a second volume, thereby causing the inner balloon 2951 to further expand to further obstruct the patient's endometrial cavity for desired vapor delivery. In one embodiment, the second volume is less than 25% larger than the first volume. The expansion also forces the fallopian tube plugs 2958, 2959 to further engage the openings of the fallopian tubes. Some ablation agent or ablation energy 2964 diffuses out from the thermally permeable outer balloon 2953 and enters the endometrial cavity, thereby ablating the endometrial tissue. In various embodiments, heating of the air within the balloon is achieved through the wall of the inner balloon, through the length of the catheter, or both. In one embodiment, the catheter 2950 includes an optional fourth catheter shaft 2965 that extends from the first catheter shaft 2952 within the inner balloon 2951 between the second catheter shaft 2955 and the third catheter shaft 2956. Thermal energy from within the fourth catheter shaft 2965 is used to further inflate the inner balloon 2951 and aid in ablation.

[0438] In one embodiment, the volume of the inner balloon 2951 is used to control the pressure applied to the wall of the uterus by the outer balloon 2953. The pressure in the inner balloon 2951 is monitored, and air is added to or removed from the inner balloon 2951 to maintain a desired therapeutic pressure in the outer balloon 2953.

[0439] Figure 20G This specification shows one embodiment of the invention. Figure 20FThe illustrated catheter 2950 is inserted into the uterine cavity 2966 of a patient to ablate endometrial tissue 2967. The catheter 2950 is inserted with a first axis 2952, extending through the patient's cervix 2968, such that a second axis 2955 is positioned along a first side of the uterine cavity 2966, and a third axis 2956 is positioned along a second side opposite to the first side. This positioning deploys an inner balloon 2951 and an outer balloon 2953 between the second axis 2955 and the third axis 2956. In the illustrated embodiment, the catheter 2950 includes an optional fourth axis 2965 to inflate the inner balloon 2951 with thermal energy and assist in the ablation of endometrial tissue 2967. In one embodiment, the inner balloon 2951 is optional, and the outer balloon 2953 performs both ablation agent size setting and delivery functions. In one embodiment, the outer balloon includes a thermal vent 2969, which closes at room temperature and opens at temperatures above body temperature. In one embodiment, the pores are formed by a shape memory alloy (SMA). In one embodiment, the SMA is a nickel-titanium alloy. In one embodiment, the austenite transformation end (Af) temperature, or the temperature at which the transformation from martensite to austenite ends, is greater than 37°C when the SMA is heated (the alloy undergoes a shape change to become open pores 2969). In other embodiments, the Af temperature of the SMA is greater than 50°C but less than 100°C.

[0440] Figure 20H This is one embodiment of the use described in this specification. Figure 20F The flowchart illustrates a method for ablating endometrial tissue using an ablation catheter, outlining the steps involved. At step 2980, a coaxial catheter is inserted into the patient's cervix, and the cervix is ​​engaged with a cervical plug. Then, at step 2981, the catheter is advanced until each fallopian tube plug is close to its opening. Then, at step 2982, each fallopian tube is engaged with its plug, a step that also involves deploying a coaxial balloon within the endometrial cavity and measuring the dimensions of the cavity. The measurement is based on the length of each advanced catheter shaft and the initial volume required to inflate the inner balloon to a predetermined pressure. At step 2983, the inner balloon is inflated to the predetermined pressure, and the volume of the endometrial cavity is calculated using the initial volume of the inner balloon at that pressure. Then, at step 2984, the measured dimensions are used to calculate the amount of ablation agent required to perform the ablation. At step 2985, the calculated dose of ablation agent is delivered through the catheter shaft into the space between the coaxial balloons. Some ablation energy is delivered into the inner balloon to inflate it to a second volume, which further expands the endometrial cavity and optionally pushes a fallopian tube plug into the fallopian tube opening to prevent thermal energy leakage. Another portion of the ablation energy is passed through the thermally permeable outer balloon to produce the desired endometrial ablation.

[0441] In another embodiment, the vapor ablation device for ablating endometrial tissue includes a catheter designed to be inserted into the endometrial cavity through the cervix, wherein the catheter is connected to a vapor generator for generating vapor and includes at least one port located within the endometrial cavity for delivering vapor into the endometrial cavity. The vapor is delivered through the port and heats and expands the gas within the endometrial cavity to maintain the endometrial cavity pressure below 200 mm Hg, and ideally below 50 mm Hg. In one embodiment, an optional pressure sensor measures and maintains the intracavitary pressure at the desired therapeutic level, wherein the endometrial cavity expands optimally to allow for uniform distribution of ablation energy without the risk of significant leakage of ablation energy outside the endometrial cavity and damage to adjacent normal tissue.

[0442] Figure 20I A bifurcated coaxial catheter 2970 for endometrial tissue ablation, as described in another embodiment of this specification, is shown. Forming a seal at the cervix is ​​undesirable because it creates a closed cavity, leading to a pressure increase when vapor is delivered into the uterus. This increases the temperature of the air within the uterus, causing thermal expansion and a further increase in intracavitary pressure. This pressure increase can force vapor or hot air to escape from the fallopian tubes, potentially causing thermal damage to abdominal organs. Continuous monitoring of intracavitary pressure and active removal of the ablation agent are necessary to prevent heat leakage outside the cavity. Reference Figure 20I The catheter 2970 includes a coaxial handle 2971, a first positioning member 2972, a first bifurcated catheter arm 2935i with a second positioning member 2938i at its distal end, a second bifurcated catheter arm 2936i with a third positioning member 2939i at its distal end, and a plurality of infusion ports 2937i along each bifurcated catheter arm 2935i, 2936i. The catheter 2970 also includes a vent tube 2976 extending through the coaxial handle 2971 and through the first positioning member 2972, such that when the first positioning member 2972 ​​is properly positioned against the cervix, the lumen of the patient's uterus is in fluid communication with the outside of the patient's body. This prevents the formation of a tight seal when the catheter 2970 is inserted into the cervix. Since the cervix is ​​normally in a closed position, the insertion of any device will unintentionally create an undesirable seal. The vent tube allows heated air or additional steam 2940i to escape as it expands with the delivery of steam and the intraluminal pressure increases. In some embodiments, the vent pipe includes a valve that allows unidirectional airflow.

[0443] Figure 20JThis specification illustrates a bifurcated coaxial catheter 2973 for endometrial tissue ablation, according to yet another embodiment. The catheter 2973 includes a coaxial handle 2974, a first positioning member 2975, a first bifurcated catheter arm 2935j having a second positioning member 2938j at its distal end, a second bifurcated catheter arm 2936j having a third positioning member 2939j at its distal end, and a plurality of infusion ports 2937j along each bifurcated catheter arm 2935j, 2936j. The catheter 2973 also includes two venting tubes 2991, 2992 extending through the coaxial handle 2974 and through the first positioning member 2975, such that when the first positioning member 2975 is properly positioned against the cervix, the lumen of the patient's uterus is in fluid communication with the outside of the patient's body. This prevents the formation of a tight or complete seal when the catheter 2973 is inserted into the cervix. Vent pipes 2991 and 2992 allow heated air or additional steam 2940j to escape as it expands with the delivery of steam and the internal pressure increases. In some embodiments, vent pipes 2991 and 2992 include valves for unidirectional air flow.

[0444] Figure 20K A water-cooled catheter 2900k for endometrial tissue ablation, according to one embodiment of this specification, is shown. The catheter 2900k includes an elongated body 2901k having a proximal end and a distal end. The distal end includes a plurality of ports 2905k for delivering vapor 2907k for tissue ablation. A sheath 2902k extends along the body 2901k of the catheter 2900k to a point proximal to the ports 2905k. During use, water 2903k is circulated within the sheath 2902k to cool the catheter 2900k. Vapor 2907k for ablation and water 2903k for cooling are supplied to the proximal end of the catheter 2900k.

[0445] Figure 20LA water-cooled catheter 2900l for endometrial tissue ablation in a patient's uterus 2907l, according to another embodiment of this specification, is shown. The catheter 2900l includes an elongated body 2901l, a proximal end, a distal end, and a sheath 2902l covering the proximal portion of the body 2901l. A cervical cup 2904l extends from and is in fluid communication with the sheath 2902l. The catheter 2900l further includes a plurality of ports 2906l at its distal end, which ports deliver ablation vapor 2908l to the uterus 2907l. Vapor 2908l is supplied to the proximal end of the catheter 2900l. Ports 2906l are located on the catheter body 2901l, distal to the sheath 2902l. The cervical cup 2904l may cover the cervix 2909l, and the distal end of the sheath 2902l extends into the cervical canal 2910l. Water 2903l is circulated in sheath 2902l and cervical cup 2904l to cool cervical canal 2910l and / or cervix 2909l, while steam 2908l is delivered through steam delivery port 2906l to ablate endometrial lining 2911l.

[0446] In various embodiments, the ablation therapy provided by the vapor ablation system of this specification is delivered to achieve the following therapeutic endpoints for uterine ablation: maintaining tissue temperature at 100°C or lower; increasing the patient's hemoglobin by at least 5% or at least 1 gm relative to pre-treatment hemoglobin; reducing menstrual flow by at least 5% relative to pre-treatment menstrual flow, if measured by menstrual pad weight; ablation of endometrial tissue in the range of 10%-99%; reducing menstrual duration by at least 5% relative to pre-treatment menstruation; reducing amenorrhea rate by at least 10% relative to pre-treatment amenorrhea rate; and patient-reported satisfaction with the uterine ablation procedure greater than 25%.

[0447] Figure 20M This specification shows a 2900m water-cooled catheter for cervical ablation as described in one embodiment, and... Figure 20N The image shows the cervix located at 2909n in the patient. Figure 20M The catheter shown is 2900m long. (See also...) Figure 20M and Figure 20NThe catheter 2900m includes an elongated body 2901m, a proximal end, a distal end, and a water-cooled tip 2902m at its distal end. A cervical cup 2914m is connected to the catheter body 2901 and includes a plurality of ports 2906m in fluid communication with the proximal end of the catheter 2900m. Vapor 2908m is provided at the proximal end of the catheter 2900m and delivered via ports 2906m to the cervix 2909n. In an embodiment, the vapor 2908m ablates the transition band 2912n at the cervix 2909n. The water-cooled tip 2902m of the catheter 2900m cools the cervical canal 2910n during ablation. In various embodiments, cooling methods known in the art can be used to cool the catheter tip.

[0448] Figure 200 Is using Figure 20M The flowchart shown illustrates the cervical ablation procedure using a catheter, outlining the steps involved. At step 2902o, the distal tip of the catheter is inserted into the cervical canal until the cervical cup of the catheter surrounds the cervix. At step 2904o, water is circulated in the water-cooled tip to cool the cervical canal. At step 2906o, steam is passed through the steam delivery port in the cervical cup to ablate the cervix.

[0449] In various embodiments, the ablation therapy provided by the vapor ablation system of this specification is delivered to achieve the following therapeutic endpoints for cervical ablation: maintaining tissue temperature at 100°C or lower; ablating the cervical mucosa without significant damage to the cervical canal; ablating at least 50% of the surface area of ​​the target abnormal cervical mucosa such that, upon healing, the abnormal cervical mucosa is replaced by normal cervical mucosa; a clearance rate of more than 25% of the abnormal cervical mucosa, as measured by colposcopy; and ablation of more than 25% of the abnormal cervical mucosa and less than 25% of the total length of the cervical canal.

[0450] Figure 21A This is a flowchart illustrating an embodiment of the endometrial tissue ablation method described in this specification. (Reference) Figure 21AThe first step 3001 includes inserting a catheter of the ablation device into the patient's uterus through the cervix, wherein the catheter includes a hollow shaft through which an ablation agent can travel, at least one first positioning member, at least one second positioning member located distal to the at least one first positioning member, and at least one infusion port for delivering the ablation agent. In an embodiment, the ablation device includes a controller, the controller including a microprocessor for controlling the delivery of the ablation agent. The catheter is passed through the cervix such that the first positioning member is located in the cervix and the second positioning member is located in the uterine cavity. In one embodiment, the second positioning member is located near the fundus of the uterus. In step 3002, the two positioning members are deployed such that the first positioning member contacts the cervix, the second positioning member contacts a portion of the uterine cavity, and the catheter and infusion port are located within the patient's uterine cavity. Finally, in step 3005, the ablation agent is delivered through the infusion port to ablate the endometrial tissue.

[0451] Optionally, in step 3003, a sensor is used to measure at least one dimension of the uterine cavity, and in step 3004, the measurement results are used to determine the amount of ablation agent to be delivered.

[0452] Figure 21B This is a flowchart of the procedure for ablating uterine fibroids. (Reference) Figure 21B The first step 3011 involves inserting a hysteroscope into the patient's uterus through the cervix. Next, in step 3012, a catheter of an ablation device is passed through the hysteroscope, wherein the catheter includes a hollow shaft through which an ablation agent can travel, a puncture tip at its distal end, at least one positioning member, and a plurality of needles at the distal end of the catheter that deliver the ablation agent to the uterine fibroid. In an embodiment, the ablation device includes a controller comprising a microprocessor for controlling the delivery of the ablation agent. The catheter is passed through the hysteroscope such that the puncture tip of the catheter punctures the uterine fibroid. In the next step 3013, the at least one positioning member is deployed such that the catheter is positioned within the uterine fibroid, and the plurality of needles at the distal end of the catheter are positioned within the uterine fibroid. Finally, in step 3014, the ablation agent is delivered through the needles to ablate the fibroid. In some embodiments, the positioning member positions the catheter at approximately half the average transverse dimension of the fibroid. In other embodiments, the positioning member positions the catheter at approximately 25%–75% of the average transverse dimension of the fibroid.

[0453] Bladder cancer ablation and treatment of OAB

[0454] Figure 22BA system 2200b for bladder tissue ablation as described in embodiments of this specification is shown. System 2200b includes a catheter 2230, which in some embodiments includes a handle 2232 having a distal tip 2238 for forwardly pushing the catheter 2230 and actuators 2234, 2236 for deploying a distal positioning member 2240 at the distal end of the catheter 2230. In an embodiment, the catheter 2230 includes an outer sheath 2242 and an inner catheter 2244. In an embodiment, the distal positioning member 2240 is deployable, located at the distal end of the inner catheter 2244, and compressible within the outer sheath 2242 for delivery. In some embodiments, actuators 2234 and 2236 include knobs. In some embodiments, actuator / knob 2236 is used to deploy the distal positioning member 2240. For example, in an embodiment, rotating actuator / knob 2236 by a quarter turn deploys the distal positioning member 2240. In some embodiments, other combinations of actuators / knobs are used to position member 2240. In some embodiments, catheter 2230 includes a port 2246 for delivering fluid (e.g., cooling fluid) during ablation. In some embodiments, port 2246 may also provide fluid connectivity, provide vacuum, and provide CO2 for integrity testing. In some embodiments, port 2246 is located on handle 2232. In some embodiments, at least one electrode 2248 is located at the distal end of catheter 2230. Electrode 2248 may receive current supplied by connection line 2250 extending from controller 2252 to catheter 2230 to heat and convert fluid, such as saline solution supplied via conduit 2254 extending from controller 2252 to catheter 2230. The heated fluid or saline solution is converted into vapor or steam to be delivered by the port for ablation. In some embodiments, catheter 2230 is made of or covered with insulating material to prevent ablation energy from leaking from the catheter body. Multiple small delivery ports are located on inner catheter 2244 between distal positioning member 2240 and electrode 2248. The port is used for infusing an ablative agent such as steam. The delivery of the ablative agent is controlled by controller 2252, and the treatment is controlled by the treating physician via controller 2252. In an embodiment, Figure 22B The 2200b system can be used to ablate the bladder and can be used in conjunction with subsequent procedures. Figures 23-28 The catheter, positioning component, and needle are used together in the context described.

[0455] Figure 23 An exemplary catheter 2302 for insertion into the bladder 2304 to perform ablation of bladder cancer 2306, as described in some embodiments of this specification, is shown. Figure 18V , Figure 18W and Figure 18XAn exemplary embodiment of the distal end of catheter 2302 is shown in the context of the diagram. The distal end 2308 of catheter 2302 is advanced through urethra 2310 into bladder 2304. A cystoscope may be used to advance the catheter, or, in some embodiments, visualization features are provided in the catheter for catheter navigation. A positioning member 2312 connected to the distal end 2308 of catheter 2302 is used to position the ablation catheter 2302 within bladder 2304. In some embodiments, positioning member 2312 comprises multiple filaments interwoven in a pattern (e.g., a spiral pattern). In embodiments, the filaments are made of a shape memory material to allow compression of positioning member 2312 during delivery. In some embodiments, the shape memory material is a nickel-titanium alloy. In various embodiments, positioning member 2312 has a disc, cone, funnel, bell, circular, elliptical, egg-shaped, or acorn-shaped form and is substantially cylindrical when compressed. When deployed, positioning member 2312 abuts and rests within bladder 2304 surrounding a portion of the tissue to be ablated.

[0456] Figure 24A , Figure 24B and Figure 24C Different views are shown of exemplary structures of the distal end of a catheter 2402 having a positioning member 2412 as described in some embodiments of this specification. Figure 24A This is the front view of the positioning component 2412. Figure 24B This is a side view of the conduit 2402 and the positioning member 2412. Figure 24C This is a front perspective view of the conduit 2402 and the positioning member 2412. Also refer to... Figure 24A , Figure 24B and Figure 24C The positioning member 2412 is pyramidal in shape with four sides, thus providing an open square form at its distal end. In some embodiments, the length and width of the positioning member 2412 at its open distal end are in the range of 13 mm to 17 mm. A conduit 2402 is connected to the positioning member 2412 at its distal end 2408. The conduit 2402 includes an outer conduit 2418 and an inner conduit 2420. In an embodiment, the positioning member 2402 is connected to the distal end 2408 of the outer conduit 2418 by a connecting mechanism. The inner conduit 2420 is located inside and coaxial with the outer conduit 2418. A vapor port 2416 is disposed on the inner conduit 2420, which provides vapor 2314 during ablation. Figure 23 It provides export services.

[0457] Figure 25A , Figure 25B and Figure 25C The design of the positioning member 2512 described in some embodiments of this specification is shown. Figure 25AThis is a close-up view of the connection 2520 between the positioning member 2512 and the catheter 2502 as described in some embodiments of this specification. In alternative embodiments, the positioning member 2512 is fused to the catheter 2502, freely floating using metal or polymer sutures, and hinged to a laser-welded nickel-titanium alloy (wherein the hinge is laser-cut) or connected to a nickel-titanium alloy sleeve welded thereto. In some embodiments, the connection 2520 is a sleeve or portion of the distal end 2508 of the catheter 2502. Figure 25B This is a side view of the positioning member 2512 connected to the distal end 2508 of catheter 2502. One or more vapor ports 2516 are disposed at the distal end of catheter 2502, on the inner catheter 2520 within the outer catheter 2518, wherein the distal portion of catheter 2502 is located within the funnel-shaped volume of positioning member 2512. In an embodiment, inner catheter 2520 is removable into and out of outer catheter 2518 such that outer catheter 2518 covers inner catheter 2520 and restricts positioning member 2512 before insertion into the patient's urethra. Positioning member 2512 is made of shape memory material such that once inner catheter 2520 is extended beyond the distal end of outer catheter 2518, positioning member unfolds into a deployed configuration, as shown... Figure 25A As shown. Figure 25C Different structural types of the positioning member 2513, which can be used in various ablation catheters, as described in embodiments of this specification, are shown. In some embodiments, the positioning member is conical, with a diameter varying from 5 mm to 50 mm. In some embodiments, the positioning member is an oval cone, wherein the first proximal diameter of the cone is smaller than the second distal diameter of the cone, to approximate the size or dimensions of the urethra. In various embodiments having multiple positioning members, the first positioning member may have a different shape or size than the second positioning member. One or more positioning members can be used to accomplish a therapeutic purpose.

[0458] In some embodiments, the positioning member 2512 is formed of filaments made of one or a combination of polymers and metals, such as, but not limited to, polyetheretherketone (PEEK) and nickel-titanium (NiTi). In some embodiments, the filaments are covered with elastomers such as PTFE, ePTFE, PU, ​​and / or si...

Claims

1. A vapor ablation system for ablation of urogenital tissue in a patient, comprising: At least one pump; A catheter extending between a proximal end and a distal tip, wherein the catheter comprises: A connection port is located at the proximal end of the catheter, wherein the catheter is in fluid communication with the at least one pump via the connection port; A handle; A first lumen extends from the handle and is in fluid communication with the connection port, wherein the first lumen has a proximal side connected to the handle and a distal side, and is configured to receive fluid from the at least one pump through the connection port. At least one electrode is located inside the distal side of the first lumen; A needle having a lumen and configured to couple to the distal tip of a catheter, such that the proximal end of the needle is at least 0.1 mm and no more than 60 mm away from the distal electrode of the at least one electrode, while the lumen of the needle is in fluid communication with the first lumen; and At least one tension wire, connected to the needle and configured to be pulled to manipulate the position or orientation of the needle tip; and A controller having at least one processor for data communication with the at least one pump, wherein the controller is configured to, upon activation, be able to: Control fluid delivery into the first lumen; and Control current is supplied to at least one electrode within the first cavity.

2. The vapor ablation system according to claim 1, wherein, The urogenital organs are the prostate, uterus, and bladder tissues.

3. The vapor ablation system according to claim 1, wherein, The needle has a tapered distal tip.

4. The vapor ablation system according to claim 1, wherein, It also includes a needle connection component, the proximal portion of the needle being configured to be threaded to the distal end of the needle connection component, the needle including an internal channel in fluid communication with the first lumen and a port, allowing vapor to enter the external environment from the internal channel.

5. The vapor ablation system of claim 1, further comprising a needle chamber coupled to the distal tip of the catheter and configured to extend and retract along the length of the catheter.

6. The vapor ablation system according to claim 5, wherein, The needle chamber has an outer surface and an inner lumen, the inner lumen defining an inner surface, wherein the outer surface comprises a first material, and the inner surface comprises a second material, wherein the first material is different from the second material.

7. The vapor ablation system according to claim 5, wherein, The needle chamber has an inner lumen that defines an inner surface, wherein the inner lumen is curved to accommodate a curved needle.

8. The vapor ablation system according to claim 5, wherein, In the undeployed state, the needle chamber is configured to be positioned above the needle, wherein, in the deployed state, the needle chamber is configured to retract towards the proximal end of the catheter, while the needle is positioned outside the needle chamber.

9. The vapor ablation system according to claim 7, wherein, The needle can be further adjusted to have three different positions relative to the catheter, wherein the different positions include a first position, a second position, and a third position. In the first position, the needle has a first curvature; in the second position, the needle has a second curvature; and in the third position, the needle has a third curvature. The first curvature is different from the second and third curvatures, and the second curvature is different from the third curvature.

10. The vapor ablation system according to claim 7, wherein, The needle can be further adjusted to have three different positions relative to the catheter, wherein the different positions include a first position, a second position, and a third position. In the first position, the needle has a first curvature; in the second position, the needle has a second curvature; and in the third position, the needle has a third curvature, wherein the first curvature is greater than both the second and third curvatures, and the third curvature is greater than the second curvature.

11. The vapor ablation system according to claim 9 or 10, wherein, In the third position, the needle is configured to extend outward from the outer surface of the catheter at an angle between 30° and 90°.

12. The vapor ablation system according to claim 1, wherein, The needle extends from the proximal end to the distal tapered end and further includes insulating material located above the needle length.

13. The vapor ablation system according to claim 12, wherein, The insulating material is adjusted to cover at least 5% of the needle length from the proximal end, and the insulating material is adjusted to cover no more than 90% of the needle length from the proximal end.

14. The vapor ablation system according to claim 1, wherein, The needle is configured to be located at half the average transverse dimension of the uterine fibroid within the fibroid.

15. The vapor ablation system according to claim 1, wherein, The needle is positioned at 25%-75% of the average transverse dimension of the uterine fibroid within the fibroid.

16. The vapor ablation system according to claim 2, wherein, The prostate, uterus, and bladder tissues mentioned are those associated with benign prostatic hyperplasia, prostate cancer, uterine fibroids, abnormal uterine bleeding, or overactive bladder.

17. The vapor ablation system according to claim 6, wherein, The first material is a polymer, and the second material is a metal.

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