Multi fluid tissue resection methods and devices

0001The present invention, as a whole, relates to medical methods and devices. In particular, the invention relates to methods and devices for energizing the urethra and prostate to reduce tissue volume.

0002Many medical conditions adversely affect the male urethra, causing a variety of symptoms including urinary pain or difficulty urinating, prostate swelling, hematuria, lower back pain, and the like. Some of these conditions, such as prostatitis, are bacterial infections and can be treated with antibiotics and other agents. However, other conditions such as benign prostatic hyperplasia (BPH) and prostate cancer result in benign prostatic hyperplasia, impaired urethra, and in some cases complete loss of bladder function.

0003Although various drug treatments for treating BPH have been found to be effective, their effectiveness is limited in duration and often requires additional treatment, such as surgery.

0004Treatment of BPH by surgery includes some aspect of radical or partial prostatectomy, in which the prostate is completely or partially removed by electrosurgery. Prostatectomy is the most invasive and effective treatment for alleviating dysuria caused by stenosis due to benign prostatic hyperplasia. Prostatectomy is considered by the American Urology Society (AUA) to be the optimal care standard for managing BHP with acute symptoms, but with the introduction of less invasive technology, the actual urology Its therapeutic use is declining rapidly. Radical prostatectomy with laparotomy is rarely used in the treatment of BHP and is used exclusively for the signs of prostate cancer.

0005Prostatectomy is performed with a laparotomy approach, a laparoscopic approach, or a transurethral approach. A transurethral approach is preferred for partial prostatectomy. This is typically done in patients with BHP with acute symptoms. Established techniques include transurethral resection of the prostate using electrocautery (TURP), transurethral resection of the prostate (TUVP), and transurethral resection of the prostate (TUIP), but transurethral. Prostatectomy is rarely used. In TURP, an electrosurgical loop is inserted into the urethra and used to remove excess prostate tissue. In contrast, TUIP makes an incision in the muscle adjacent to the prostate gland, relaxes the bladder opening, and relieves difficulty urinating. TUVP has been shown to produce results comparable to standard TURP, but reduce surgical morbidity and length of stay. Instead of an electrosurgical loop, TUVP uses a rollerball that can deliver enough energy to evaporate the prostate tissue.

0006Over the last decade, medical device manufacturers have developed minimally invasive (MI) energy-based technologies for BPH. These techniques seek to reduce the morbidity and complications associated with electrosurgery approaches, allow treatment in a relatively economical outpatient setting, and fail in drug treatment, but electricity such as TURP. Suitable for patients who are severe enough to justify the surgical procedure. These MI technologies include transurethral microwave thermotherapy (TUMT), transurethral dynamic high frequency needle ablation (TUNA), water-induced thermotherapy (WIT), and intraprostatic lasers using transurethral optical fibers. There are several laser ablation techniques such as coagulation (ILC), transurethral dynamic formium laser prostate enucleation (HoLEP), and photoselective prostate evaporation (PVP).

0007Although generally successful, TUMP, TUNA, and WIT are not suitable for the treatment of all patients and all conditions. In particular, patients with severe tissue invasion into the urethral lumen due to BHP or prostate cancer are difficult to treat with these methods using tissue contraction rather than tissue resection. Thus, many of these patients ultimately require conventional surgical resection.

0008In contrast, HoLEP and PVP can actively remove tissue by transpiration. However, HoLEP has not spread due to the limitation of long operation time and long learning time.

0009Therefore, the Urology Society has recently endorsed PVP, which has relatively low technical requirements. In this technique, a laser beam with an output of 60w to 120w is applied from the urethra to the prostate tissue to achieve a level of irradiance (output density) higher than a specific volumetric output density called the evaporation threshold. Below this level, the tissue coagulates without evaporation. When the irradiance level is above the transpiration threshold, tissue transpiration increases and coagulation decreases. However, the beam emitted from the probe in the PVP system is diffuse. Therefore, as the distance from the tissue to the probe increases, the laser spot expands, the output density decreases, and the transpiration rate decreases. Therefore, in order to maximize the rate of transpiration and thereby limit the extent of the thermal injury zone characterized by tissue coagulation remaining after surgery, physicians have placed the fiber at a predetermined distance (eg, 1 mm to 2 mm) from the tissue. The target tissue should be scanned with a beam at all times and without changing the distance. As the surgery progresses, the tissue becomes carbonized, making ablation even more difficult. Thus, a major limitation of PVP is that the rate of tissue removal slows as the surgery progresses. This significantly increases the time required for surgery and increases the cost and risk of treating the patient. Moreover, the effectiveness and time of this surgery is highly dependent on the skill of the treating physician and uses a very expensive high power laser system.

0010In addition, the surgery described above requires very high energy for tissue coagulation and / or evaporation. Such extremely high energy cannot be generated without the use of large, high-power, expensive equipment.

0011In addition, current treatments for BPH are often at high risk of complications. For example, TURP causes complications such as retrograde ejaculation, postoperative discomfort, erectile dysfunction, severe hematuria, and acute urinary retention and incontinence. These postoperative complications result from excision, ablation, or other damage to non-glandular tissue within the prostatic urethral region, such as the seminal vesicles, sphincter, intraprostatic blood vessels, nervous tissue, or fibromuscular pores. In addition, therapeutic methods that use selective pyrolysis to ablate, coagulate, or degenerate target tissue to adequately reduce prostate volume are prone to large heat-damaged tissue zones. As a result, edema and swelling of the prostate tissue treated with heat occur, and the patient's symptoms leading to urinary retention cannot be immediately alleviated, requiring postoperative catheter placement and hospitalization.

0012In addition, the symptoms of benign prostatic hyperplasia, such as BPH, often result in urethral disorders, thus preventing transurethral prostate treatment methods and devices by obstruction of abnormal tissue. This is because the device cannot be properly moved within the enclosed space to provide treatment for the desired area. Thus, the therapeutic device is prevented from functioning properly or optimally. In addition, obstruction by abnormal tissue limits visibility into the treatment procedure and generally interferes with optimal treatment.

0013For this reason, it is desirable to provide less invasive methods and devices for dilating the lumen and / or performing volumetric excision of the tissue surrounding the urethra. It is particularly desirable that these methods and devices for removing tissue without the use of heat allow the tissue to be excised without causing thermal damage to the tissue. This for removing or destroying the tissue surrounding the urethra, which can remove what is generated by the removal or destruction from the lumen, even when removing a relatively large volume of tissue to relieve the pressure acting on the urethra. It is particularly desirable to provide such methods and devices. In addition, it is desirable to provide methods and devices that minimize postoperative complications by selectively excising glandular tissue so that non-glandular tissue is substantially free of damage. Further, it is desirable to provide a method and a device for expanding the treatment area by forming a work space in which the device can be easily moved and the treatment area can be easily seen. In another aspect, or in addition, methods and devices for immobilizing the therapeutic device to the urethra must be provided to provide a stable platform for the therapeutic protocol. Methods and devices for performing such protocols should be of minimal risk to the patient, should be relatively easy for the treating physician to perform, and complications even in critically ill patients. Should be able to alleviate the symptoms by minimizing. At least some of these objectives are achieved by the present invention as described below.

0014The use of transurethral endoscopes for bipolar high-frequency transpiration is described in the literature of the Journal of the Endoscopy Society (J. Endourol) (2001), Vol. 15, pp. 313-316, etc. .. High-frequency discharge in physiological saline to generate tissue ablation plasma is described in the Institute of Electrical and Electronics Engineers, Institute of Electrical and Electronics Engineers (IEEE Trans. Plasma Sci.) (2002), Vol. 30, pp. 13761383. It is discussed in the literature of Koffsky et al. And in the literature of the Institute of Electrical and Electronics Engineers (Appl. Phys. Lett.) Vol. 79, pp. 4503-4505, such as Starder. An air / water jet for excising tissue is Trans. It is described in the literature of Jiang and Jiajun on pages 246-248 of ASME (2001). U.S. Patent Application Publication No. 20050288369 describes a needle injector in a catheter-based system that can be secured to the urethra by an intravesical balloon. U.S. Pat. Nos. 6,890,332, U.S. Pat. No. 6,821,275, and U.S. Pat. No. 6,413,256 each describe catheters for generating high-frequency plasma for tissue ablation.

0015The use of lasers to cut biological tissue is described in US Patent Publication No. 20020128637, and ablation of prostate tissue is described in US Pat. No. 5,257,991, US Pat. No. 5,514,669, and US Pat. No. 6,986,764. Are listed. Pressurized water streams for making surgical incisions are described in US Pat. No. 7,122,017, US Pat. No. 5,620,414, and US Pat. No. 5,505,729. Using a jet of water or other fluid as a waveguide for transporting laser beams for cutting and other manufacturing operations can be used as US Patent Application Publication No. 20070278195, Canadian Patent Application Publication No. 2,330436. It is described in A1, PCT Publication WO 99/56907, and US Pat. No. 7,163,875, US Pat. No. 5,902,499, and US Pat. No. 5,773,791.

0016U.S. Pat. No. 6,960,182 describes the use of liquid jet instruments to remove tissues such as the joint capsule of the knee. Here, the nozzles form a liquid jet, which is received by the jet receiving opening. U.S. Pat. No. 5,135,482 describes a hydrodynamic device for eliminating organic deposits that partially or completely block the lumen of the human body. These patents do not disclose the use of fluid flow to remove tissue within a closed tissue area, such as the prostatic urethral area. U.S. Pat. No. 5,782,848 describes the use of water jets for excision of coagulated tissue. The patent does not disclose the use of fluid flow for excision of non-coagulated or untreated tissue.

0017U.S. Pat. No. 5,207,672 states that a balloon is used to compress a portion of the prostate gland and a laser beam is used to ablate the tissue. The patent does not disclose the use of fluid flow to remove tissue after dilating the urethra.

0018U.S. Patent No. 4,560,373, U.S. Patent No. 3,818,913, U.S. Patent No. 4,913,698, U.S. Patent No. 5,505,729, and U.S. Patent Application Publication No. 20090149712 and U.S. Patent Application Publication No. 20090157114 vary using fluid flow. It is described to treat various tissues. These patents and patent applications do not disclose the use of fluid flow to remove tissue within a closed tissue area, such as the prostatic urethral area. Various other aspects of fluid jet surgery, such as pumps and applicators, include U.S. Patent No. 5,037,431, U.S. Patent No. 6,720,745, U.S. Patent Application Publication No. 20070129680, U.S. Patent Application Publication No. 20080038124, and U.S. Patent Application Publication. It is described in 20080243157, US Patent Application Publication No. 20080221602, and US Patent Application Publication No. 20090060764.

0019US Patent Application Publication No. 20080097470 of Gruber et al. Discloses the use of mechanical expansion and fluid jet excision in gynecological procedures. The application does not describe the use of fluid flow for excision of a given volume of tissue. U.S. Patent Application Publication No. 20080188868, U.S. Patent Application Publication No. 20080249526, and U.S. Patent Application Publication No. 20090287045 disclose, for example, fluid jet tissue resection in laparoscopic surgery. As is generally well known, laparoscopic surgery creates a working space within the abdominal cavity, not inside the organ in which the surgery is performed. The publication of the above application does not describe inserting the device into an organ, creating a working space within the organ, and using fluid flow to excise the tissue of the organ.

<p num="0020"><patcit num="1"><text>U.S. Patent Application Publication No. 20050288639</text></patcit><patcit num="2"><text>U.S. Pat. No. 6,890,332</text></patcit><patcit num="3"><text>U.S. Pat. No. 6,821,275</text></patcit><patcit num="4"><text>U.S. Pat. No. 6,413,256</text></patcit><patcit num="5"><text>U.S. Patent Application Publication No. 20020128637</text></patcit><patcit num="6"><text>U.S. Pat. No. 5,257,991</text></patcit><patcit num="7"><text>U.S. Pat. No. 5,514,669</text></patcit><patcit num="8"><text>U.S. Pat. No. 6,986,764</text></patcit><patcit num="9"><text>U.S. Pat. No. 7,122,017</text></patcit><patcit num="10"><text>U.S. Pat. No. 5,620,414</text></patcit><patcit num="11"><text>U.S. Pat. No. 5,505,729</text></patcit><patcit num="12"><text>U.S. Patent Application Publication No. 20070278195</text></patcit><patcit num="13"><text>Canadian Patent Application Publication No. 2,330436 A1</text></patcit><patcit num="14"><text>PCT public WO 99/56907</text></patcit><patcit num="15"><text>U.S. Pat. No. 7,163,875</text></patcit><patcit num="16"><text>U.S. Pat. No. 5,902,499</text></patcit><patcit num="17"><text>U.S. Pat. No. 5,773,791</text></patcit><patcit num="18"><text>U.S. Pat. No. 6,960,182</text></patcit><patcit num="19"><text>U.S. Pat. No. 5,135,482</text></patcit><patcit num="20"><text>U.S. Pat. No. 5,782,848</text></patcit><patcit num="21"><text>U.S. Pat. No. 5,207,672</text></patcit><patcit num="22"><text>U.S. Pat. No. 4,560,373</text></patcit><patcit num="23"><text>U.S. Pat. No. 3,818,913</text></patcit><patcit num="24"><text>U.S. Pat. No. 4,913,698</text></patcit><patcit num="25"><text>U.S. Pat. No. 5,505,729</text></patcit><patcit num="26"><text>U.S. Patent Application Publication No. 20090149712</text></patcit><patcit num="27"><text>U.S. Patent Application Publication No. 20090157114</text></patcit><patcit num="28"><text>U.S. Pat. No. 5,037,431</text></patcit><patcit num="29"><text>U.S. Pat. No. 6,720,745</text></patcit><patcit num="30"><text>U.S. Patent Application Publication No. 20070129680</text></patcit><patcit num="31"><text>U.S. Patent Application Publication No. 20080038124</text></patcit><patcit num="32"><text>U.S. Patent Application Publication No. 20080243157</text></patcit><patcit num="33"><text>U.S. Patent Application Publication No. 20080221602</text></patcit><patcit num="34"><text>U.S. Patent Application Publication No. 20090060764</text></patcit><patcit num="35"><text>U.S. Patent Application Publication No. 20080097470</text></patcit><patcit num="36"><text>U.S. Patent Application Publication No. 20080188868</text></patcit><patcit num="37"><text>U.S. Patent Application Publication No. 20080249526</text></patcit><patcit num="38"><text>U.S. Patent Application Publication No. 20090287045</text></patcit></p>

<p num="0021"><nplcit num="1"><text>Journal of the Endoscopic Society (J. Endourol) (2001) Vol. 15, pp. 313-316, Boffo, etc.</text></nplcit><nplcit num="2"><text>Materials from the Institute of Electrical and Electronics Engineers, Plasma Science Conference (IEEE Trans. Plasma Sci.) (2002), Vol. 30, pp. 1376 to 1383, Wolkovsky et al.</text></nplcit><nplcit num="3"><text>American Physical Society Breaking News (Appl. Phys. Lett.) Vol. 79, pp. 4503-4505, Stalder, etc.</text></nplcit><nplcit num="4"><text>Trans. ASME (2001), pp. 246-248, Jiang and Jiajun</text></nplcit></p>

<p num="0022"> The methods, devices, and systems according to the invention alleviate symptoms such as BPH, prostatitis, and prostate cancer in which the enlargement of the prostate causes damage to the urethra and the urethra is compressed and partially or completely blocked. Treat the tissue.</p>

<p num="0023"> In the first aspect, the method for excising the prostate tissue comprises positioning a device with a fluid delivery element within the lumen of the urethra within the prostate. Direct the fluid flow outward from the fluid delivery element towards the wall of the urethral lumen. The fluid flow has sufficient force to remove the tissue. To alleviate the symptoms associated with lumen obstruction, the fluid delivery element is moved and scanned across the wall with fluid flow to remove a given volume of tissue surrounding the lumen. The fluid delivery element delivers water, saline, or other fluid. Optionally, these liquids are combined with therapeutic substances, combined with other treatments such as chemotherapy, and radiopharmaceuticals containing anesthetics, antibiotics, vasoconstrictors, anti-inflammatory agents, or therapeutic radioisotopes. Is introduced. The fluid may be combined with gas, soluble material, or crystalline particles to improve cutting efficiency.</p><p num="0024"> There are many advantages to excising the tissue using a fluid stream according to the examples of the present invention. Depending on selected morphological parameters such as fluid source pressure, fluid flow shape, treatment time, and treatment pattern, excision is performed very quickly. The fluid flow technique of the present invention removes tissue at an order of magnitude faster than conventional techniques such as laser ablation. Moreover, because no heat source is required to excise the tissue, the method is performed virtually without heating, thus leaving no heat-damaged zones in the treated tissue. Therefore, there is little or no postoperative swelling, eliminating or reducing the need for catheter placement and immediate relief from symptoms. In addition, the use of fluid flow for tissue excision reduces the risk to the patient by eliminating the use of other energy sources in the body that may possibly cause nerve damage.</p><p num="0025"> The fluid flow excision technique further provides the advantage of selectively excising tissue at appropriate pressure. Fluid pressure and other properties can be determined so that soft tissue is removed but relatively hard structures such as articulated structures are subject to little fluid flow action. In addition, the fluid flow may be formed to form a divergent fluid flow, thereby reducing the impact exerted on the tissue relatively distant from the fluid delivery element. This protects the prostatic sac and large arteries and veins from damage during surgery.</p><p num="0026"> To form a working space within the urethra, the method of the invention further introduces a fluid for injecting gas into the area of the urethra where treatment is performed before or during delivery of a fluid stream for excision of tissue. Including the process. The use of such gas infusion helps control the distance from the pressurized fluid source to the surface of the tissue to be treated. Further, the gas injecting fluid may be selected to be a medium with a lower viscosity than the excision fluid. This reduces the resistance that the excision fluid encounters during tissue excision and maintains the shape integrity of the excision fluid flow. Furthermore, these two fluids are selected so that the difference in the refractive index of these fluids causes internal reflection, more specifically total internal reflection, in the excision fluid so that the excision fluid transmits electromagnetic energy. Serves as a conduit for delivering, for example, ablation or other energy to the tissue. Optionally, mechanical means may be used to form the workspace.</p><p num="0027"> The method of the present invention further comprises removing the fluid delivered to the therapeutic area as well as tissue debris and fluid generated by excision. In addition, saline or other fluid may be injected and flushed into the treatment area before, during, or after treatment with a fluid stream.</p><p num="0028"> Tissue excision according to the embodiments of the present invention is typically performed using a strong fluid stream, but in some cases other therapeutic energies before, during, or after delivery of the strong fluid stream. It is advantageous to send out. In such other methods, the fluid flow may not be strong enough to excise the tissue. Such energy is delivered to enhance tissue excision, but in some cases to perform tissue cauterization, typically after the completion of treatment with a strong fluid flow. Suitable energy sources include laser energy, high frequency energy, thermal energy, low temperature energy, etc., and broadly include adding electromagnetic energy, mechanical energy, vibration energy, thermal energy, and / or electrical energy. Is done.</p><p num="0029"> The process of positioning the pressurized fluid source is typically the process of advancing the probe into the urinary tract, injecting the pressurized fluid through a fluid delivery element (such as one or more nozzles) movably attached to the probe. Includes a pointing step and a step of moving the fluid delivery element relative to the probe and scanning across the wall with a fluid stream. The probe is provided by a balloon or other inflatable element located at the distal end of the probe and / or by an external anchor frame formed to non-traumatically engage with an external region of the body such as the base of the penis. It may be fixed, which stabilizes the probe from back and forth. By thus immobilizing the distal end of the probe within the bladder, the fluid delivery element provided on the probe is accurately positioned relative to the bladder neck and thus the fluid delivery element is the prostate in the urethra. Accurately positioned at the tissue. It is especially advantageous to use anchors. This is because the procedure of the present invention can be performed without an endoscope, an X-ray fluoroscopy device, or another imaging device. However, the procedure of the present invention may be carried out in combination with video technology. By stabilizing the device with anchors, the fluid delivery element can be moved accurately, which aids in procedure automation.</p><p num="0030"> The fluid delivery element is typically positioned at the end of a lumen or tube that penetrates or extends across the probe, allowing the fluid delivery element to translate and / or rotate with respect to the axis of the probe. The fluid flow may be divergent, tapered, or have a constant cross-sectional area after exiting the fluid delivery element. Typically, the fluid delivery element is moved and treated in a predetermined manner over the cylindrical volume of prostate tissue surrounding the urethra. In another aspect, the fluid delivery element scans over a non-cylindrical, and possibly asymmetrical area within the urethra that has been determined to be the target of treatment. Typically, the pressurized fluid source includes a power pump that can be driven under control to deliver the desired pressure through the fluid delivery element.</p><p num="0031"> The present invention further provides a device for treating the prostate. Such devices include elongated elements (eg, shafts) with proximal and distal ends. To secure the elongated element to the bladder, an inflatable anchor, such as an inflatable balloon, is secured at or near the distal end of the elongated element, and an external anchor frame engages with the outer surface of the body, such as the base of the penis. By fitting, it provides additional stability. At least one fluid delivery element is connected to an elongated element and is located in front of the anchor. The fluid delivery element can move relative to the elongated element, typically axially, rotationally or oscillatingly with respect to the elongated element. The fluid may be directed at approximately perpendicular or at right angles to the elongated element, or at any other angle to the elongated element. The elongated element may include one or more lumens that perform additional parts of the protocol of the invention. For example, a lumen may be provided to deliver pressurized gas or other fluid to the urethra for gas injection into the urethra. Further, a lumen for removing the excised debris from the treatment area, a lumen for delivering the flushing fluid, and the like may be provided. The elongated element has dimensions suitable for introduction into the prostate through the urethra. The elongated element may include means for delivering any energy source, such as laser energy, high frequency energy, thermal energy, cold energy, etc., discussed herein with respect to the method.</p><p num="0032"> The present invention specifically relates to transurethral treatment of the prostate, but specific embodiments of the present invention include brain, heart, lung, intestine, eyeball, skin, kidney, liver, pancreas, stomach, uterus, ovary, testicle, bladder, and the like. Other organs such as ears, nose, bone marrow, adipose tissue, muscle, glandular tissue, soft tissue such as spinal tissue, hard biological tissue such as teeth and bone, and sinus and conduit, urethra, colon, esophagus, It can also be used to treat or modify internal cavities and passages such as bladder and blood vessels. The devices disclosed herein may be inserted through existing internal lumens or through hard body tissue.<u style="single">The present specification also provides, for example, the following items.</u><u style="single">(Item 1)</u><u style="single"> In a tissue modification device for transurethral treatment of the prostate,</u><u style="single"> An elongated element having proximal and distal ends and formed to be inserted into the urethra,</u><u style="single"> A first lumen in the elongated element formed to deliver a first fluid into the urethra and form a working space.</u><u style="single"> A fluid delivery element disposed within the elongated element, formed to release a second fluid different from the first fluid as a fluid flow that excises the volume of prostate tissue surrounding the urethra.</u><u style="single"> A device comprising an external anchor frame that comes to engage the base of the penis when the shaft is in the urethra.</u><u style="single">(Item 2)</u><u style="single"> In the device described in item 1,</u><u style="single"> The pressure in the work space is 0.03515 kg / cm</u>^{<u style="single">2</u>}<u style="single">~ 0.17575kg / cm</u>^{<u style="single">2</u>}<u style="single">A device formed to deliver the first fluid until it is within the range (0.5 psi to 2.5 psi).</u><u style="single">(Item 3)</u><u style="single"> In the device described in item 1,</u><u style="single"> A device formed to deliver the fluid flow having a given fluid flow shape and fluid flow pressure selected to selectively excise the tissue.</u><u style="single">(Item 4)</u><u style="single"> In the device according to item 1, 2, or 3.</u><u style="single"> The fluid delivery element is a device that is formed to translate, rotate, swing, or rotate with respect to the elongated element.</u><u style="single">(Item 5)</u><u style="single"> In the device according to any one of items 1 to 4.</u><u style="single"> It is formed to deliver a sufficient amount of the first fluid into the working space to form a predetermined volume of the first fluid, and the fluid flow passes through the volume of the first fluid. A device to move around.</u><u style="single">(Item 6)</u><u style="single"> In the device described in item 5,</u><u style="single"> A device in which the first fluid is a gas and the second fluid is a liquid.</u><u style="single">(Item 7)</u><u style="single"> In the device according to any one of items 1 to 6, further</u><u style="single"> A device comprising a visualization element disposed within the elongated element and formed to visualize the tissue.</u><u style="single">(Item 8)</u><u style="single"> In the device according to any one of items 1 to 7, further</u><u style="single"> The device comprises an energy conduit formed to transfer energy through the interior of the fluid stream and cauterize the tissue, the device being sufficient to transfer the force of the fluid stream to the tissue. A device that is formed to drop to a level that is insufficient to excise.</u><u style="single">(Item 9)</u><u style="single"> In the device described in item 8, further</u><u style="single"> A device formed to excise the tissue using the energy transmitted through the interior of the fluid stream.</u><u style="single">(Item 10)</u><u style="single"> In the device described in item 8,</u><u style="single"> A device in which the energy is electromagnetic energy such as light energy or high frequency energy.</u><u style="single">(Item 11)</u><u style="single"> In the device according to any one of items 1 to 10, further</u><u style="single"> A device comprising an inflatable anchor near the distal end of the elongated element, the inflatable anchor being formed to inflate within the bladder and stabilize the elongated element during excision.</u><u style="single">(Item 12)</u><u style="single"> In the device according to any one of items 1 to 11, further</u><u style="single"> A device having a second lumen within the elongated element to apply suction to the tissue around the fluid delivery element and remove excision products.</u><u style="single">(Item 13)</u><u style="single"> In the device described in item 12,</u><u style="single"> A device formed to maintain a predetermined pressure difference between the first lumen and the second lumen for aspirating excision products through the second lumen.</u><u style="single">(Item 14)</u><u style="single"> In the device described in item 12,</u><u style="single"> A device in which the first lumen is formed to direct the first fluid towards the fluid delivery element, thereby maintaining the integrity of the fluid flow.</u> The present invention has other advantages and features that become apparent from the following detailed description of the invention and the appended claims by reading with reference to the accompanying drawings.</p>

0033<figref num="1">FIG. 1 is a schematic view of a device suitable for performing transurethral prostate tissue weight loss according to the principles of the present invention.</figref><figref num="2">2A-2D show the use of the device of FIG. 1 in performing prostate tissue weight loss.</figref><figref num="3">FIG. 3 is a diagram of a particular prostate tissue treatment device that uses radiofrequency saline plasma to perform prostate tissue weight loss.</figref><figref num="4">FIG. 4 is a diagram showing an energy source that delivers a fluid stream for excision of tissue, suitable for use in the devices of the present invention.</figref><figref num="5">FIG. 5 shows an energy source including a deflected optical waveguide for delivering laser energy to the prostate tissue, suitable for use in the devices of the present invention.</figref><figref num="6">FIG. 6 shows a device similar to the device shown in FIG. 5, except that the optical waveguide directs the laser energy to the mirror and the mirror deflects the laser energy laterally.</figref><figref num="7">FIG. 7 shows an energy source that includes laterally protruding electrodes that can engage the prostate tissue and urethra to deliver high frequency energy for tissue ablation, suitable for use in the devices of the invention. Is.</figref><figref num="8">FIG. 8 is a graph of tissue resection rate showing critical pressure.</figref><figref num="9a">FIG. 9a is a flow diagram showing controlled selective resection.</figref><figref num="9b">FIG. 9b is a flow diagram showing selective resection in which a fluid flow was formed to penetrate the urethral wall prior to resection of prostate tissue.</figref><figref num="10a">FIG. 10a is a diagram showing a columnar fluid flow and a divergent fluid flow.</figref><figref num="10b">FIG. 10b is a cross-sectional view of a tissue repair device formed to emit a columnar fluid flow.</figref><figref num="10c">FIG. 10c is a cross-sectional view of a tissue repair device formed to release a divergent fluid flow.</figref><figref num="11">FIG. 11 is a graph of penetration time when using divergent fluid flow as a function of the distance between the tissue and the fluid delivery element.</figref><figref num="12">FIG. 12 is a graph of the critical pressure indicated by the change in excised tissue when a divergent fluid flow is used, as a function of the distance and pressure between the tissue and the fluid delivery element.</figref><figref num="13">FIG. 13 is a graph of glandular tissue resection rate as a function of pressure and the distance between the tissue and the fluid delivery element.</figref><figref num="14">FIG. 14 is a graph of the ratio of excision rate of glandular tissue to sac tissue.</figref><figref num="15">FIG. 15 shows a tissue repair device that uses fluid flow to excise tissue, where fluid flow optionally acts as a conduit for electromagnetic energy.</figref><figref num="16">FIG. 16 shows a tissue repair device positioned in the urethra where tissue contact with the device makes the device inefficient.</figref><figref num="17">FIG. 17 is a diagram showing the tissue repair device shown in FIG. 16 positioned in the urethra, where the device expanded the surrounding tissue to form a working space.</figref><figref num="18">FIG. 18 is a flow diagram showing the operation of the tissue modification device.</figref>

0034Although the following detailed description includes many theories, they should not be construed as limiting the scope of the invention, but merely exemplify various examples and embodiments of the invention. It should be understood that the scope of the invention includes other examples not described in detail in the above. Others apparent to those skilled in the art with respect to the configuration, operation, and details of the methods and devices of the invention disclosed herein, without departing from the spirit and scope of the invention described herein. Various modifications and changes may be made.

0035Referring to FIG. 1, an exemplary prostate tissue weight loss device 10 formed according to the principles of the present invention includes a catheter assembly. The catheter assembly as a whole includes a shaft 12 with a distal end 14 and a proximal end 16. The shaft 12 is typically a polymeric extrusion, one, two, three, four, or more extending from hub 18 at the proximal end 16 to a location near the distal end 14. Includes axial lumen. The shaft 12 is typically 15 cm to 25 cm in length, 1 mm to 10 mm in diameter, and typically 2 mm to 6 mm. The shaft has sufficient column strength for introduction upwards through the male urethra, as described in more detail below.

0036The shaft contains an energy source positioned in the energy delivery region 20. The energy source may be any one of the many specific components discussed in more detail below. An inflatable fixed balloon 24 is positioned distal to the energy delivery region, at or in the immediate vicinity of the distal end 14 of the shaft. The balloon is connected to the balloon expansion source 26, which is connected through the hub 18, through the lumen of one of the axial lumens. In addition to the energy source 22 and the balloon expansion source 26, the hub is optional, but in addition, an injection / flushing source 28, a suction (vacuum) source 30, and / or a gas (pressurized CO).₂Or other gas) includes a connection to the injection source 32. In an exemplary embodiment, the injection source / flushing source 28 is one or more located proximal to the balloon anchor 24 and distal to the energy delivery region 20 through an axial lumen (not shown). Can be connected to the sending port 34 of. The suction source 30 can be connected to the second port, that is, the opening 36. This second port 36 is typically positioned proximal to the energy delivery region 20, but the gas source 32 can be connected to an additional port 38. This additional port is also typically located proximal to the energy delivery region 20. The locations of ports 34, 36, and 38 are not important, but specific locations provide the specific benefits described herein, and the lumen and delivery means are coaxial sleeves that can be positioned, eg, on shaft 12. It will be appreciated that it can be provided by additional catheters, tubes, etc., including sheaths, etc.

0037Although this example describes the human prostate, it will be appreciated that these examples may be used to treat the prostate in common mammals. Next, referring to FIGS. 2A-2D, the prostate tissue weight loss device 10 is introduced through the male urethra U into a region within the prostate P located just distal to the bladder B. FIG. 2A shows the anatomy. After positioning the catheter 10 so that the anchor balloon 24 is located just distal to the bladder neck BN (see Figure 2B), the balloon is inflated, preferably approximately inside the bladder as shown in Figure 2C. Occupy the whole. After the anchor balloon 24 is inflated, the prostate tissue weight loss device 10 is fixed and stabilized in the urethra U so that the energy delivery region 20 is positioned within the prostate P. It will be appreciated that the energy delivery region 20 is properly positioned by simply inflating the anchor balloon 24 within the bladder. Because the prostate is just proximal to the bladder neck BN, the distal end of the energy delivery region 20 is typically 0 mm to 5 mm, preferably 1 mm to 3 mm away from the immediate vicinity of the proximal end of the balloon. The transmission area can be arranged properly. After the anchor balloon 24 is inflated, energy can be delivered into the prostate as shown by the arrows in the figure for weight loss. After delivering energy for the desired time and over the desired surface area, the energy area is stopped, the prostate is reduced in weight, and the pressure exerted on the urethra is released, as shown in FIG. 2D. At this time, as shown in FIG. 2D, the flushing fluid is sent out through the port 34 and sucked into the port 36. Optionally, after treatment, the area may be cauterized using a cauterizing balloon and / or a stent that can be placed using a modified or separate catheter device.

0038Next, many exemplary energy delivery regions will be described with reference to FIGS. 3-7. Then referring to FIG. 3, the first exemplary prostatectomy device 110 formed according to the principles of the present invention includes a shaft 112 with a proximal end 114 and a distal end 116. A plurality of nozzles 118 are attached to the shaft 112 at a distance of 1 cm to 5 cm in the proximal direction from the distal end 116. These nozzles are typically a ceramic core capable of generating plasma, or a port capable of directing a flow of conductive fluid outward in the radial direction and are attached to structure 120. The structure 120 allows the nozzle 118 to be moved radially outward as shown by the broken line in FIG. An anchor 122, shown as an inflatable balloon, is attached to the distal end 116 of the shaft 112 between the nozzle 118 and the distal tip 124. The inflatable structure 122 can be inflated in the bladder to secure the shaft 112 such that the nozzle array 118 is in the prostate, as described in more detail below. The shaft 112 is provided with lumens, passages, conductive wires, etc. to deliver energy and material from the proximal end 114 of the shaft to the distal end 116. For example, the high frequency energy source 126 is connected to the shaft 112, usually the nozzle 118, to deliver high frequency energy from the fluid source 128 to the nozzle 118, typically to the conductive fluid delivered through the lumen of the shaft 112. ing. Other lumens, channels, or conduits are provided to allow suction to the vacuum source 130. The vacuum source 130 is typically connected to one or more suction ports 132. In order to introduce a flushing fluid such as saline from the flushing fluid source 134 to the port 136, another conduit may be provided in the shaft 112. In other cases, the suction source 130 and the flushing fluid source 134 can be connected to a common port so that suction and flushing occur sequentially rather than simultaneously. In addition, optionally, the gas injection source 140 May be provided with a lumen, conduit, or the like to connect to one or more gas injection ports 142 provided in the array region 118 of the shaft. Finally, a lumen, conduit, or the like may be provided to connect the balloon 122 to the balloon expansion source 144.

0039As shown in FIG. 4, the illustrated energy delivery region 20 can be formed by a high pressure nozzle 200 provided in a delivery tube 380 arranged in the shaft 12. The carrier tube 380 can be translated axially as indicated by arrow 204 and / or rotated as indicated by arrow 206 so that the fluid flow 208 radiated from nozzle 200 is the entire or selected urethra within the prostate. You can scan the part, that is, you can rasterize it. Specific pressures and other details for such hypertensive water treatments are described, for example, in the above-mentioned Jiang and Jiajun literature.

0040Next, referring to FIG. 5, the energy source in the energy delivery region 20 may include a fiber optic waveguide or fiber bundle 220 supported on a rotary-translation shaft 380. The optical waveguide 220 transfers a laser or other coherent light energy with the beam 222. By rotating and / or translating the carrier tube 380, the beam 222 can be scanned, ie, rasterized, across the urethral wall and prostate tissue.

0041As shown in FIG. 6, laser energy from the optical waveguide or fiber bundle 230 may be directed axially to the mirror 232. In this figure, both the waveguide and the mirror are supported on a rotary-axial translational carrier tube 380. Again, the rotation and translation of the carrier tube 380 allows the emitted beam 234 to scan across the urethral wall, i.e. raster.

0042Next, referring to FIG. 7, in yet another embodiment, the rotary-axial translation tube 380 supports an electrode 240 that projects laterally from the tube. Electrodes 240 are adapted to be connected to a high frequency energy source such that high frequency energy is delivered in either monopolar or bipolar mode when the electrodes come into contact with the urethral wall and prostate tissue. Thus, high frequency energy applies ablation to the tissue over selected volumes and regions of the prostate tissue. Optionally, the electrode 240 may be used for post-treatment tissue ablation by altering the nature of the high frequency energy.

0043In one embodiment of the invention, the device is formed to remove some tissue composition and leave other tissue composition intact by selectively excising the tissue. For example, the prostate and nearby regions include various tissue compositions including glandular prostate tissue, intraprostatic blood vessels, fibromuscular foramen, sac tissue, sphincter muscle, seminal vesicles, and the like. When treating BPH or other prostate conditions, it is desirable to remove the glandular prostate tissue and leave other tissues, such as blood vessels and sac tissue, substantially intact.

0044As mentioned above, the term excision includes any tissue removal, including removal of one or more tissue cell clumps, removal of small portions of tissue cells, and the like.

0045One advantage of treating BPH with selective excision of tissue is that there is less (or no) need for cauterization. This is because bleeding is limited because there is little or no damage to the blood vessels in the prostate. Another advantage is that incontinence and incapacity are reduced. This is because selective excision reduces the risk of damage to surrounding tissues such as the prostatic sac, sphincter, seminal vesicles, etc. due to perforation or the like.

0046When fluid flow is used for tissue excision, selective tissue excision is performed by changing one or more fluid flow parameters such as pressure in the nozzle or other fluid delivery element and fluid flow rate. be able to. As a result, some tissue compositions are resected while leaving others substantially intact.

0047In one embodiment, the fluid flow parameters are such even if the non-target tissue is exposed to the fluid flow for an extended period of time, typically sufficient time to perform the desired excision. It is defined to leave tissue other than the target, substantially intact. In another embodiment, the fluid flow parameters are defined to excise the target tissue much faster than the non-target tissue, thereby limiting damage to the non-target tissue. These parameters may be adjusted depending on the target tissue to be selectively resected.

0048In one example, the excision rate is defined to be higher for glandular tissue than for non-glandular tissue. The excision rate may be determined by varying the fluid pressure or by adjusting other fluid flow parameters, as described above. Specifically, the excision rate for glandular tissue is defined to be significantly higher than the excision rate for non-glandular tissue so that the non-glandular tissue remains effectively intact during the treatment period. For example, the rate of excision of glandular tissue is defined to be at least twice the rate of excision of non-glandular tissue. In another example, the rate of excision of glandular tissue is determined to be at least ten times the rate of excision of non-glandular tissue.

0049It should be noted that there is a critical pressure for tissue excision (pressure below which excision is not performed and above this pressure allows tissue excision). This is because the tissue is stretched on a small scale to the point where the tissue matrix is cut, and the process of tearing the tissue is included in the removal process. Since the structure is elastic, there is a critical breaking point. Different types of tissue have different critical break points and therefore different critical pressures in each tissue. Indeed, given a particular size of fluid delivery element (nozzle diameter, etc.), each tissue type is typically the critical pressure of the fluid source (P)._critAlso called). Below the critical pressure, the excision rate approaches zero, above which the excision rate increases monotonously, perhaps exponentially. Specifically, due to differences in tissue composition, the pressure of the fluid source selectively excises certain types of tissue, leaving other types of tissue with relatively high critical pressures almost intact.

0050An important aspect of excising tissue in a multi-tissue environment according to this example is that surgery can be performed in a regime where one type of tissue is excised and another type of tissue remains substantially intact. That is. This is most pronounced when surgery is performed at a given pressure between the critical pressures of the two types of tissue. As can be seen in Figure 8, the surgical pressure P for fluid flow_{o o}Is greater than the critical pressure of tissue 1 (P)_{o o}&gt; P_crit1) Therefore, the excision rate of zero or more is applied to the tissue 1, and at the same time, the pressure P_{o o}Is kept below the critical pressure of tissue 2 (P)_{o o}&lt;P_crit2) Therefore, tissue 2 is defined to have a near zero excision rate. In such a form, the fluid stream is formed so as to selectively excise tissue 1 but not tissue 2.

0051In one embodiment formed to treat BPH, the fluid source pressure is set to be higher than the critical pressure of the glandular prostatic tissue but lower than the critical pressure of the non-glandular prostatic tissue. In such examples, the pressure is high enough to remove the glandular tissue, but too low to remove or damage non-glandular tissue such as intraprostatic blood vessels, fibromuscular pores, sac tissue, etc. .. In one embodiment, the fluid is about 0.0703 kg / cm before leaving the fluid delivery element.²~ Approximately 2109 kg / cm²Pressures in the range (about 1 psi to about 30000 psi), more preferably about 3.515 kg / cm²~ Approximately 105.45kg / cm²Pressure in the range (about 50 psi to about 1500 psi), most preferably about 7.03 kg / cm²~ About 70.3kg / cm²Pressurized to a pressure in the range (about 100 psi to about 1000 psi).

0052The following examples exemplify the critical pressure of fluid flow excision of some tissues. Note that the text below is provided as an example and should not be construed as limiting. Example 1: Illustrative critical pressures of various kidney tissue compositions Tissue critical pressure was measured in porcine kidney. Kidney tissue was selected because its composition resembles that of prostate tissue. A columnar fluid stream with a diameter of approximately 200 μm was used to excise the tissue. The glandular tissue (the pink outer part of the kidney) is very soft and can be easily cut by finger pressure, but the inside of the kidney contains relatively strong vascular tissue. The critical pressure of glandular tissue for this fluid flow is approximately 5.624 kg / cm.²(Approximately 80 psi) and the critical pressure of vascular tissue is approximately 35.15 kg / cm²It turned out to be (about 500psi). See Table 1 below.

0053<tables num="1"><img id="000002" he="25" wi="159" file="JP5905397B2_D0001.tif" img-format="tif" img-content="drawing" /></tables>

0054For example, about 35.15 kg / cm using a nozzle with a diameter of about 200 μm₂In an experiment in which a pig kidney was resected at a liquid source pressure of (about 500 psi), the glandular tissue was about 10 cm.²Excision of the area exceeding the above is performed at a speed of about 1 cm (10 cc every 30 seconds) in 30 seconds, but for vascular tissue, it is less than about 0.1 cm in 180 seconds, and the difference in excision speed is about 60 times. Thus, more glandular tissue than vascular tissue is resected within the same resection period. This allows the excision period to be defined so that the glandular tissue can be excised without substantially damaging the vascular tissue. The excision rate can be adjusted by varying the fluid source pressure and / or the size of the nozzle. For example, the excision rate for glandular tissue can be adjusted to about 1 cc per minute, about 5 cc per minute, about 10 cc per minute, about 30 cc per minute, or any other rate. As explained above, changing the size of the nozzle inevitably changes the fluid source pressure to cause the fluid flow to collide with the tissue with sufficient force to achieve the desired excision rate. Understand.

0055FIG. 9a is a flow diagram showing a method for selectively excising the prostate according to one example. In step 700, the device is positioned and fixed in the urethra as described above. In step 701, various fluid parameters such as fluid source pressure and fluid flow shape are defined to remove certain types of tissue, such as glandular prostate tissue. By defining the fluid parameters, the excision is selectively performed under the control, so that the fluid force, the excision rate, the treatment time, the area of the tissue to be excised, and the like can be controlled. After defining the parameters, in step 702 the device releases a fluid stream and excises the target tissue. When the treatment is confirmed to be complete in step 703, the device is removed from the urethra in step 704.

0056However, if it is confirmed in step 703 that the treatment has not yet been completed, the fluid parameters are redefined or reconstituted as needed in step 701 and the process cycle is repeated until the treatment is complete. In particular, the reconstruction of fluid parameters is advantageous in embodiments where it is desirable to remove two different types of tissue to complete the treatment. In such embodiments, the fluid parameters are adjusted to account for changes in the type of target tissue to be excised.

0057Typically, after excision of some or all of the glandular tissue, other types of tissue, such as vascular tissue or sac tissue, are exposed to fluid flow. Although fluid flow parameters are defined to selectively excise glandular tissue, fluid parameters may be significantly adjusted to take into account the gradual exposure of non-glandular tissue during the excision procedure. , The excision selectivity may be fine-tuned as needed. After reconstitution of the fluid parameters in step 701, the reconstituted fluid flow is released in step 702 to continue excision of the tissue and continue surgery until treatment is complete.

0058In particular, note that when treating the prostate from within the urethra, the urethral wall is sandwiched between the fluid source (nozzle or other fluid delivery element) and the target glandular prostate tissue to be excised. Therefore, in one embodiment, first, a portion of the urethral tissue (eg, the urethral wall) is excised and fluid flow parameters are defined to penetrate it. However, since the composition of the glandular prostate tissue is weaker than that of the urethral tissue, it is desirable to prevent the glandular tissue from being excised with the same fluid dynamics used to excise the urethral wall. To do this, a fluid stream is used for a period sufficient to excise and penetrate the urethral wall but not otherwise. The glandular prostate tissue is then resected using a reduced fluid flow.

0059FIG. 9b is a flow diagram showing a method for selectively removing the prostate. In this figure, the fluid flow is defined to first penetrate and excise the urethral wall according to one embodiment. In step 801, the device is positioned and secured in the urethra as described above. In step 802, the device is set to release a fluid stream of sufficient force to penetrate and excise the urethral wall. In step 803, fluid is selectively excised after the fluid flow has penetrated the urethral wall, but to a level that leaves intraprostatic vessels, sac, and other non-glandular tissue substantially intact. Adjust the flow.

0060In addition, the shape of the fluid flow is also thought to influence selective excision. Although the fluid flow is shown in FIG. 10 as a columnar fluid flow 333 or a divergent fluid flow 334, it is believed that the fluid flow may have any shape or shape that can be excised according to this example. In detail, both the columnar fluid flow morphology and the divergent fluid flow morphology have many advantages, as described in detail below.

0061In columnar fluid flow form 333, the device emits the fluid flow as a substantially focused rod-like fluid column with a substantially zero divergence angle. In one embodiment, the columnar fluid flow is formed as an entirely linear or non-divergent fluid flow. In such a form, the device emits the fluid flow in a substantially cylindrical or other non-divergent form, thereby delivering energy to the tissue over one region, i.e. at the distance of the tissue from the fluid delivery element. Communicate with a spot of a fixed size. Optionally, the fluid flow may be tapered to concentrate the energy delivered to the tissue, for example if the fluid delivery element contains a large number of nozzles, or if the fluid contains air bubbles.

0062FIG. 10b is a cross-sectional view of a device that emits a columnar fluid stream to change tissues such as the prostate. Place the device's elongated element 310 (such as the shaft described above) in the urethra U. A fluid delivery element 320 arranged in a carrier tube (not shown) within the elongated element 310 is formed to discharge a columnar fluid flow 333. As can be seen, the fluid delivery element 320 includes the nozzle described above or any other element formed to discharge the fluid. The columnar fluid flow 333 is formed to excise tissues such as the urethral wall UW and the prostate tissue P in the excision region RA.

0063One feature of the columnar fluid flow morphology is that the excision region RA is substantially constant within a predetermined distance from the fluid delivery element 320. This is because the width of the excision region RA is substantially determined by the fluid distance from the fluid delivery element 320. This is advantageous because the fluid flow 333 remains in constant focus on the excision region RA as it moves away from the fluid delivery element 320, which transfers energy to the tissue in the focal region. When excising or penetrating tough tissue such as the urethral wall UW, it is particularly advantageous to concentrate energy within the focal excision region RA. In one embodiment, the columnarity of the fluid flow changes with fluctuations in the introduction pressure in delivering the fluid. For example, the columnarity of the fluid flow can be changed mechanically. This is done by introducing an entirely solid object into the fluid delivery path, eg, behind the hole in the fluid delivery element 320, or in the path of the fluid flow after exiting the hole in the fluid delivery element 320 under control. Will be done. In another example, a vibrating element such as a piezoelectric element may be introduced into the flow path to generate pressure fluctuations to change the columnarity of the fluid flow.

0064In another embodiment, the fluid flow is formed as a divergent fluid flow 334 as shown in FIG. 10a. The divergent fluid flow 334 is a fluid flow in which the fluid exits the fluid source such as the fluid delivery element 320 and spreads divergently in a substantially conical shape, and the tip of the conical shape is at the fluid source. The excision velocity of the divergent fluid flow 334 is expressed as a function of the distance z from the fluid delivery element 320 that discharges the fluid to the tissue to be excised. As shown in FIG. 10a, z2 is farther from the orifice than z1, so the excision rate at z1 is higher than the excision rate at z2.

0065The divergent fluid flow 334 is characterized by the opening angle of the fluid flow. In one embodiment, the opening angle is defined to be from about 0 ° to 90 °, more preferably from about 2 ° to 45 °, even more preferably from about 4 ° to 20 °, and most preferably from about 7 °. It is considered that the opening angle may be changed as needed.

0066Further, the divergent fluid flow 334 is characterized by the cross-sectional shape of the fluid flow. In general, the divergent fluid flow 334 has a predetermined cross-sectional area or spot size that increases with distance from the fluid source (eg, fluid delivery element 320). This reduces the force per unit area of the fluid flow in proportion to the distance. This increases the overall size of the spot and increases the rate of excision of tissue near the fluid source.

0067In one embodiment, the cross-sectional shape of the divergent fluid flow 334 has a narrow rectangular shape as a whole (fan-shaped fluid flow), and in another embodiment, the cross-sectional shape of the divergent fluid flow 334 has a circular shape as a whole. (Conical fluid flow), the minimum cross-sectional area is at the fluid source. Note that the cross-sectional shape of the divergent fluid flow 334 may be formed in any shape (eg, elliptical or irregular shape) surrounding the nonzero region.

0068FIG. 10c is a cross-sectional view of a device that emits a divergent fluid flow to modify tissues such as the prostate. Place the elongated element 310 of the device within the urethra U. A fluid delivery element 320 arranged in a carrier tube (not shown) within the elongated element 310 is formed to release a divergent fluid flow 334. The divergent fluid flow 334 is formed to excise tissues such as the urethral wall UW and the prostate tissue P in the excision region RA. The excision region RA covered by the divergent fluid flow 334 increases with the distance traveled by the fluid flow from the fluid delivery element 320, thereby reducing the strength of the fluid flow per unit area proportionally.

0069The divergent fluid flow 334 is characterized in that the cut width increases as a function of the distance from the fluid delivery element 320 and at the same time the cut rate per unit area decreases as a function of the distance from the fluid delivery element 320. This is because the total energy delivered by the fluid flow is almost constant (without considering the decrease in fluid velocity), but this energy is delivered over a relatively large area. Thus, the energy delivered per unit area is reduced. This is an important parameter that affects the excision rate. Therefore, the excision rate per unit area decreases as a function of distance.

0070Further, in the divergent fluid flow 334, the volume excision velocity is almost constant as a function of distance. That is, although the excision rate per unit area decreases, the total excised area increases proportionally, and thus the total excision volume remains substantially constant. Note that if the area cut rate, which is a function of the area energy density, is non-linear and increases monotonically with energy, the volume cut rate decreases as a function of the distance from the fluid delivery element 320. Furthermore, it should be noted that the volume ablation velocity decreases as a function of distance even if the fluid flow particles (for example, droplets) slow down.

0071The following example illustrates tissue resection using a divergent fluid flow. Note that the forms described below are examples and should not be construed as limiting. Example 2: Tissue penetration using divergent fluid flow. Figure 11 shows the data measured by excision of the tissue of the canine prostate sac. The penetration time of the sac was measured as a function of the distance from the tissue to the fluid delivery element. The opening angle of the fluid flow was about 7 °. Penetration time was plotted as the time required to penetrate the sac. The thickness of the sac is less than 1 mm.

0072FIG. 11 shows that the penetration time increases as the distance from the tissue to the fluid delivery element increases. This effect is greater as the fluid source pressure is lower. Furthermore, it should be noted that the penetration time of the columnar fluid flow is largely independent of the tissue distance to the fluid delivery element.

0073Example 3: Critical pressure and prostate tissue resection using divergent fluid flow. Figure 12 shows changes in critical pressure as a function of various distances in excision by divergent fluid flow measured for canine prostatic sac tissue. The excision rate was measured as the reciprocal of the time required to excise (ie, penetrate) the entire thickness of the bag. The excision velocity was measured as a function of fluid source pressure and tissue distance from the fluid delivery element. The excision rate increases at relatively high pressures as the distance from the fluid delivery element increases. This increase in excision rate indicates critical pressure. An increase in critical pressure as a function of distance indicates that in divergent fluid flow, the effectiveness of excision decreases with distance.

0074FIG. 13 shows the excision rate of canine glandular tissue by divergent fluid flow as a function of source pressure and the distance from the tissue to the fluid delivery element. Critical pressure (approx. 21.09 kg / cm²Above (about 300 psi)), the sensitivity to pressure changes is high when the target structure is relatively close to the fluid delivery element. If it is desirable to selectively excise the glandular tissue while preserving the sac tissue, relatively high pressure is used to excise the glandular tissue near the fluid delivery element, but further away from the fluid delivery element. The sac tissue is preserved, further assisting excision.

0075The relative excision rate of two different tissues is shown in FIG. 14 as the ratio of the excision rate of glandular tissue to the excision rate of sac tissue. As you can see in Figure 14, about 35.15 kg / cm²There is a clear maximum ratio at an intermediate pressure of (about 500 psi). This indicates the operation between the two critical pressures described above and indicates that the tissue can be selectively excised by setting the pressure range appropriately.

0076Example 4: Critical distance for excision using divergent fluid flow. When performing divergent fluid flow excision at a given pressure, there are critical excision distances as shown in Table 2 below. As can be seen in Table 2, if the fluid flow is more than about 10 mm from the tissue, the dog's bladder does not penetrate due to the divergent fluid flow. In addition, the advantages of using a divergent fluid flow for the purpose of selective excision are illustrated.

0077<tables num="2"><img id="000003" he="51" wi="159" file="JP5905397B2_D0001.tif" img-format="tif" img-content="drawing" /></tables>

0078It is an advantageous feature of the present invention that a tissue such as prostate tissue can be excised without the need to perform ablation, weakening, mechanical degeneration, or other treatment on the tissue before excision. Target tissue can be weakened by essentially removing the target tissue from the tissue matrix of the body area using procedures such as tissue ablation, thereby pretreatment with a low-strength fluid flow. Although tissue can be easily removed, these procedures require a two-step process (the process of weakening the tissue and then removing the weakened tissue from the tissue matrix), resulting in unwanted harmful side effects such as exacerbation of inflammation. .. Therefore, it is an advantageous feature of the present invention that the target tissue can be excised using a fluid stream without the need for prior ablation, modification, or tissue treatment.

0079As explained above, fluids may be used to inject gas into the urethral lumen to create a working space before or during the delivery of energy to the prostate tissue. FIG. 15 shows an exemplary tissue repair device formed to inject gas and excise tissue. A unique problem with tissue modification within a closed tissue system is the lack of a suitable working space between the tissue modification device and the surrounding tissue of the body area. The presence of such a workspace is advantageous, among other things, because it can increase energy transfer efficiency, enable efficient means for removing generated debris, and provide a better view of the tissue area. .. The devices and methods for forming a workspace and modifying the tissue by using it, and the advantages of these devices and methods are described in more detail below. The following examples are illustrated by way of example in the context of prostate treatment, but the present invention presents closed tissue in which one tissue or anatomical structure corresponds to or compresses another tissue or anatomical structure. It is believed that it can be used to modify any tissue in the system, and it is advantageous to form a workspace before modifying the tissue.

0080Then referring to FIG. 15, the device includes an elongated element 310, such as a shaft, formed to be inserted into a body part. The elongated element 310 comprises a window that exposes the carrier tube 380 and other components described below. Through the window, the carrier tube 380 and the high pressure fluid delivery element 320 located on the carrier tube 380 are exposed. The fluid delivery element 320 is connected to a fluid source (not shown) via a fluid lumen 390. The fluid lumen 390 delivers fluid from the fluid source to the fluid delivery element 320.

0081Optionally, when introducing the elongated element 310 into the urethra, the elongated element 310 is covered by a sheath or other cover (not shown). When the entire sheath is covered, the window is protected from scratching or damaging the urethra as it advances the elongated element 310. After reaching the desired location, retract the sheath to expose the window. The carrier tube 380 is then rotated forward and / or retracted to deliver fluid through the fluid delivery element 320.

0082Further, and optionally, the device may include a shield element (not shown) positioned to substantially cover the fluid delivery element 320 and maintain space between it and the fluid delivery element 320. .. This effectively maintains space between the fluid delivery element 320 and any tissue that hits the shield element. In one embodiment, the shield element is a substantially flat sheet-like element positioned on the fluid delivery element 320. The shield element is positioned or shaped so that the carrier tube 380 can move within the elongated element 310 as needed. For example, the shield element may be curved according to the curvature of the carrier tube 380. The shield element has an opening that allows the fluid flow released by the fluid delivery element 320 to move unobstructed through the opening and hit the tissue. The opening may be circular or may have other shapes. One advantage of such a shield element is that it protects the fluid delivery element 320 from damage during insertion or removal procedures and / or treatment. Another advantage of the shield element is that the fluid returning towards the fluid delivery element 320 during or after the discharge of the fluid passes through the opening of the shield element (or through other paths around the shield element) and the shield element. It means moving into the space between and the fluid delivery element 320. Such a return fluid then flows through the space and the release of the fluid is not blocked by such a return fluid.

0083The shield element may be further formed so that the space between the shield element and the fluid delivery element 320 is continuously communicated with the waste disposal lumen through a flow path having a low flow resistance. This forms a low flow resistance flow path between the fluid delivery element 320 and the external destination of such waste, from the region where the waste and fluid exiting the fluid delivery element 320 surrounds the fluid delivery element 320. Easily leave. The low resistance in this case should be understood to mean that the flow resistance is low compared to the flow resistance of the fluid delivery element 320. This form advantageously creates no back pressure at the fluid delivery element 320, which allows the fluid flow released by the fluid delivery element 320 to move unimpeded by waste and return fluid.

0084The fluid delivery element 320 may be a single nozzle, multiple nozzles, or an array of nozzles of various forms. The fluid delivery element 320 is formed to discharge the fluid as the fluid flow 331 radially outward with sufficient force for the fluid flow 331 to excise the tissue upon contact with the tissue. The fluid flow 331 may be perpendicular to the elongated element 310 or may be formed at various angles with respect to the elongated element 310.

0085The carrier tube 380 can be axially translated, rotated, rocked, or swung relative to the elongated element 310 so that it can be scanned or rasterized with fluid flow 331 to excise the desired area or volume of tissue. I can move. The desired area or volume may be spherical, cylindrical, or any other predetermined area or volume of any shape and size.

0086Further, and optionally, if the device is not used for tissue excision, the fluid delivery element 320 and / or any other element (such as a visualization element or ablation element) may be positioned away from the window. The carrier tube 380 may be positioned in the window. This reduces the risk of damage to such elements and reduces the risk of accidental excision of tissue.

0087The device further includes at least one gas injection port 340 located on the elongated element 310. The gas injection port 340 is connected to a gas injection source (not shown) through one or more lumens. The gas injection source delivers fluid 330 into the body part through the gas injection port 340 to expand the surrounding tissue and form a working space. The device further includes at least one take-out port 360 for removing generated debris such as excision product, excision fluid, other waste or mixtures thereof. The elongated element 310 is formed to deliver energy and / or material from the proximal end to the distal end of the elongated element 310 and / or to remove debris and waste as described in detail above. Includes lumens, passages, conductive wires, etc.

0088Optionally, the device may include, in addition to the fluid delivery element 320, an electromagnetic energy delivery port 350 located near or within the fluid delivery element 320 located on the carrier tube 380. The electromagnetic energy 332 is delivered to the energy delivery port 350 by one or more conduits 351 such as an optical fiber or other waveguide in the carrier tube 380 and the elongated element 310, as described in more detail below. Will be done. The electromagnetic energy 332 may be high frequency energy, coherent or non-coherent light, or electromagnetic energy of any other aspect. The energy delivery port 350 is formed to deliver energy 332 through the interior of the fluid stream 331 such that the electromagnetic energy 332 performs tissue ablation instead of or in combination with fluid ablation.

0089Further, and optionally, the various electromagnetic energy modes described herein are formed to cauterize the tissue in combination with or separately from the excision of the tissue. Such ablation is entirely necessary because selective tissue resection disclosed herein generally causes little or no damage to residual tissue, such as vascular tissue, and therefore little or no bleeding. It is not unheard of, but it is only needed in limited cases. When electromagnetic energy is delivered to the tissue by the fluid stream 331 for cauterization, the fluid source pressure is adjusted to be well below the critical pressure for excision of the tissue so that no further excision of the tissue is performed. In another aspect, or additionally, cauterization is performed using other means such as a cauterizing balloon and / or a stent placed in contact with the tissue using a catheter device, eg, as described above. May be good.

0090In addition, the device deflects the fluid released by the fluid delivery element 320, positioned away from the window, eg, inside an elongated element 310, and returns it towards the fluid delivery element 320, thereby causing the fluid delivery element during tissue excision. It may include a voluntary deflecting element formed to remove debris that has accumulated on the 320 and / or the energy delivery port 350. Further, the fluid delivery element 320 in combination with the deflecting element may be formed to clean part or almost all of the fluid delivery element 320, any visualization or cauterization element, and / or the carrier tube 380. .. The deflecting element may be formed to be substantially flat or concave. In another aspect, the deflecting element may be formed in any shape or design.

0091Further, the deflecting element may actually be formed as a protective element for the fluid delivery element. The fluid delivery element may be positioned at a specific position with respect to the protection element. The protective element protects the prostate from the unexpected release of fluid and protects the fluid delivery element 320 from clogging or obstruction of tissue, for example during insertion and removal into the body.

0092Next, referring to FIG. 16, the tissue modification device is shown in a state of being introduced into a body part. The body part is exemplified as the prostate-urethral region PU. Abnormalities such as BPH or other tissue properties interfere with the device by surrounding tissue T, which makes treatment difficult. After introducing the elongated element 310 into the urethra, as shown in FIG. 16, the surrounding tissue T effectively blocks the fluid delivery element 320, and the carrier tube 380 is properly axially translated and rotated relative to the elongated element 310. Prevents rocking or rotational rocking. To solve this shortcoming, as shown in FIG. 17, the device inflates the surrounding tissue T, thereby forming a workspace, within which the device excises tissue T using fluid flow 331. It is formed to do.

0093Expansion of the surrounding tissue T can be performed in various ways. In one embodiment, the device is formed to inflate the surrounding tissue T by delivering a first fluid 330 through the gas injection port 340. The fluid 330 contacts the surrounding tissue T and inflates it, thereby forming a working space WS around the carrier tube 380 and the fluid delivery element 320.

0094In another embodiment, the device is formed to inflate the surrounding tissue T by mechanical means. In one such embodiment, one or more stents or mechanical structures are placed on the elongated element 310 and spread within the body part. Expansion is performed by using one or more inflatable balloons or by forming a stent (such as a nitinol stent) to exhibit a shape memory effect. This allows the stent to expand upon release from the enclosed space. In another aspect, it may be extended by other means well known to those of skill in the art. In another embodiment, one or more inflatable balloons placed on the elongated element 310 are used to expand the surrounding tissue T. These balloons are inflated by a fluid such as gas or liquid.

0095The steps of forming the work space WS in the body part include the steps of expanding the surrounding tissue T, extending the surrounding tissue T, repositioning the surrounding tissue T, deploying the surrounding tissue T, and / or within the body part. Is considered to include any other steps that form the workspace WS. After the workspace WS is formed, the carrier tube 380 can be axially translated, rotated, rocked, or swung relative to the elongated element 310, exposing in the workspace WS and the fluid delivery element 320 is no longer in the surrounding tissue T. Not blocked by. At this point, the device can effectively initiate treatment by delivering a second fluid 331 as a fluid stream and excising the surrounding tissue T.

0096Forming the fluids 330 and 331 in different media has many advantages, as described in more detail below. In one exemplary embodiment, the first fluid 330 used to expand the tissue to form a workspace WS is a gas and a pressurized CO.₂, CO, N₂, He, Ar, other biocompatible gases, or combinations thereof. The second fluid 331 used for tissue excision is water, saline, other biocompatible liquids, or liquids such as combinations thereof.

0097Further, and optionally, the second fluid 331 may contain one or more soluble substances such as sodium chloride or barium sulphate. One advantage of using such soluble materials is to increase excision efficiency by adding corrosive strength to the second fluid 331. Indeed, depending on the concentration of soluble material in the second fluid 331, the excision efficiency increases and the fluid pressure required for excision decreases. Another advantage of using such soluble substances is that they help eliminate or reduce bleeding.

0098In another aspect, and optionally, the second fluid 331 may further contain crystalline particles throughout. These particles improve excision efficiency and reduce the fluid pressure required for excision. In one embodiment, the crystalline particles may be calcium, magnesium, aluminum, manganese, iron, nickel, copper, zinc, strontium, barium, bismuth, chromium, vanadium, lanthanum, salts thereof, or combinations thereof. Good. In another example, the crystalline particles are titrate, fumarate, acetate, propionate, butyrate, caprylate, valerate, lactate, citrate, malate, gluconate. , Chloride, potassium, phosphate, or a cation salt such as a combination thereof. In yet another embodiment, the crystalline particles are calcium citrate, tartrate acid, calcium succinate, calcium fumarate, calcium adipate, calcium malate, calcium lactate, calcium gluconate, dicalcium phosphate anhydride, calcium phosphate, It may be dicalcium phosphate anhydride, calcium chloride, calcium acetate monohydrate, or a combination thereof. Further, the crystalline particles may be any solid particles.

0099The lifetime of crystalline particles may be at least 30 days, at least 10 days, at least 1 day, at least 1 minute, at least 10 seconds, or at least 1 second. In addition, the dimensions of the crystalline particles are smaller than the dimensions of the holes in the fluid delivery element 320 so that the particles are small enough to pass through the fluid delivery element 320. In addition, the particles are formed small enough so that the fluid delivery element 320 is not clogged. To do this, the maximum size of the particles is generally a fraction of the minimum size of the opening of the fluid delivery element 320, preferably about 1/10 to 1/2. In one embodiment, the maximum size of the crystalline particles is generally less than half the minimum size of the holes in the fluid delivery element 320. In another embodiment, the maximum size of the crystalline particles is generally less than 1/4 of the minimum size of the hole in the fluid delivery element 320. In yet another embodiment, the maximum size of the crystalline particles is generally less than 1/10 of the minimum size of the holes in the fluid delivery element 320.

0100Further, one or more gases are dissolved in the second fluid 331 in order to improve the cutting efficiency. CO₂, CO, N₂, He, Ar, other biocompatible gases, or combinations thereof. In one embodiment, the device is formed such that after discharging the second fluid 331 from the fluid delivery element 320, bubbles form before the fluid 331 reaches the tissue. In another embodiment, the device is formed such that air bubbles form in the second fluid 331 when colliding with tissue. The device is formed to use a combination of such effects that some bubbles form before the collision with the tissue and some bubbles form at the time of the collision.

0101Optionally, the temperature of the second fluid 331 is set to be well below the temperature of the tissue in order to reduce or eliminate bleeding by constricting the blood vessels. In addition, the temperature of the second fluid 331 may be high enough to aid in excision or cauterization.

0102The pressure of the first fluid 330 formed as a gas is about 0.00703 kg / cm.²~ About 0.3515kg / cm²It is in the range (about 0.1 psi to about 5.0 psi), preferably about 0.03515 kg / cm.²~ Approximately 0.17575kg / cm²It is considered to be in the range of (about 0.5 psi to about 2.5 psi). Optionally, a pressure sensor may be provided to monitor the pressure of the first fluid 330 so that the pressure is kept within the desired range. Furthermore, the source pressure of the second fluid 331 formed as a liquid is about 0.0703 kg / cm.²~ Approximately 140.6 kg / cm²It is in the range (about 1 psi to about 2000 psi), more preferably about 3.515 kg / cm.²~ Approximately 105.45kg / cm²It is in the range (about 50 psi to about 1500 psi), most preferably about 7.03 kg / cm.²~ About 70.3kg / cm²It is considered to be in the range of (about 100 psi to about 1000 psi).

0103Optionally, the gas injection port 340 may be located on the elongated element 310 in the immediate vicinity of the fluid delivery element 320. In such a form, the first fluid (eg, gas) 330 delivered into the workspace WS by the injection port 340 is carried outward by the fluid flow formed by the second fluid (eg, liquid) 331, and the excision fluid. It forms a siege around the stream, which helps preserve the integrity of the stream. Since the gas injection port 340 is provided near the fluid delivery element 320, the fluid delivery element 320 is protected from accumulation of fluid and tissue, thereby maintaining fluid flow integrity.

0104FIG. 18 is a flow diagram showing an exemplary operation of the device. In step 1101, an elongated element 310 is introduced into a body part such as the prostate-urethral region PU. In step 1102, the elongated element 310 is manipulated in place, the anchor element (not shown) is engaged, and the elongated element 310 is stabilized for subsequent work. The anchor element may include an anchor balloon and / or an external anchor frame, which allows the elongated element 310 to be proximal and distal by stabilizing the elongated element 310 within the therapeutic area. It is formed so as not to be substantially displaced in the direction.

0105The anchor balloon is formed to inflate just distal to the bladder neck. Inflate the anchor balloon to occupy a sufficient portion of the bladder and prevent the elongated element 310 from moving significantly beyond the treatment area (away from the bladder) during surgery. The expansion of the anchor balloon is performed by various means described in the above sentence. In another aspect, other expansion structures such as the Nitinol semi-arch skeleton may be used as the anchor element instead of the balloon.

0106The outer anchor frame is formed to engage the outer surface area of the body, eg, the surface area of the base of the penis. The external anchor frame typically includes a non-traumatic ring for engaging with the outer surface area of the body. In one embodiment, an elongated element 310 is introduced into the therapeutic area, the anchor balloon is inflated to close a portion of the bladder, and then the non-traumatic ring engages the external body area at the base of the penis. Advance the anchor frame coaxially onto the penis either automatically or manually. After the external anchor frame engages the external body area, the elongated element 310 is substantially prevented from moving beyond the therapeutic area (towards the bladder). Anchor elements, including anchor balloons and external anchor frames, are elongated because the elongated element 310 is substantially compressed within the therapeutic area by ensuring that it does not shift proximally and distally beyond the therapeutic area. It is formed to substantially stabilize the element 310. In addition, the anchor element stabilizes the device so that the fluid delivery element can be moved accurately. This aids in the automation of treatment procedures. Advantageously, in such an embodiment formed to use the external anchor frame in combination with the balloon, the balloon does not need to substantially fill the bladder to stabilize the device. This is because inflating the balloon to fill a portion of the bladder can provide sufficient stability. The fixation procedure is also described in the pending patent application No. 2009/0227998.

0107In step 1103, after stabilizing the position of the elongated element 310, the window cover provided on the elongated element 310 is retracted to expose the gas injection port 340, the removal port 360, and the carrier tube 380.

0108In step 1104, the gas injection port 340 delivers a first fluid 330 to a body part to inflate the surrounding tissue T, thereby forming a workspace WS. In step 1105, the fluid delivery element 320 delivers the second fluid 331 as a fluid stream and excises the surrounding tissue T in the workspace WS.

0109As mentioned above, different media for the first fluid 330 and the second fluid 331 provide many advantages. For example, if the expanding fluid 330 is formed in a medium that is less viscous than the excision fluid 331, the fluid source pressure or flow rate required to excise the tissue using the second fluid 331 is with the second fluid 331. Lower than when filling the workspace WS with a fluid that is the same (or highly viscous) medium. This is because if the second fluid 331 moves through the workspace WS filled with the first fluid 330, which is the same or viscous medium, the second fluid 331 is in the workspace before reaching the target tissue. This is because we have to overcome greater resistance within the WS.

0110Another advantage of the two-medium embodiment relates to the integrity of the fluid flow. Due to friction or resistance between the fluid flow created by the first fluid 330 and the second fluid 331 in the workspace WS, the fluid flow is structurally due to a portion of the second fluid 331 being scattered from the flow. Gradually lose oneness. Such scattering is not desirable because a large scattered fluid flow with reduced excision effect reaches the surrounding tissue T and damages the surrounding healthy tissue due to reduced excision accuracy. In order to maintain the integrity of the fluid flow in such a high resistance workspace WS, a high pressure must be applied to the liquid 331 to cope with the fluid scattering rate. In contrast, by forming a working space WS with a first fluid 330 made of a medium (eg gas) whose viscosity is relatively lower than that of the first fluid 330, the fluid flow 331 has a relatively low source pressure or Flow rates can be used, yet adequate fluid flow integrity and ablation effects are maintained. In another aspect, the resistance between the first fluid 330 and the second fluid 331 may be defined to cause the fluid flow to scatter so that the cutting force is reduced at the desired distance from the fluid delivery element 320. Good. The first fluid 330 may be adjusted (eg, the pressure of the gas) to determine the distance at which scattering affects the excision rate in a desired manner.

0111Another advantage of the two-medium embodiment relates to the difference in refractive index between the two media. In an optional embodiment, step 1105 delivers electromagnetic energy 332 through the interior of the fluid stream to cauterize the tissue, excise the tissue, or a combination thereof. In such an embodiment, the excision fluid flow acts as a conduit for transmitting electromagnetic energy, and the difference in refractive index between the fluid in the workspace WS and the excision fluid flow is inside the excision fluid flow. It is defined so that energy can be transmitted more efficiently. Furthermore, when acting as a conduit for transmitting electromagnetic energy, the flow and force of the fluid flow is defined to be sufficient to transfer energy to the tissue but not to excise the tissue. it is conceivable that.

0112Specifically, if the index of refraction of the first fluid 330 (eg gas) is determined to be lower than the index of refraction of the second fluid 331 (eg liquid), then all internal reflections or almost all in the fluid flow. Internal reflection occurs. In such a form, more electromagnetic energy moving through the fluid flow reaches the target tissue at the desired position, and less electromagnetic energy diffuses into the work space WS. Therefore, conduction efficiency can be improved and the amount of electromagnetic energy 332 at the source can be reduced, yet the cauterization and / or ablation effect is maintained, which reduces the power consumption of the device and the dangerous radiation effect on the patient. Reduce. The types of electromagnetic energy considered in the present invention include optical energies such as high frequency energy, coherent light (eg, laser energy) or non-coherent light.

0113In step 1106, the generated excision debris is removed from the workspace WS (along with the fluid used for excision) through the removal port 360. In one embodiment, the removal port by creating a positive pressure difference between the removal port 360 and the gas injection port 340 so that the generated debris travels through the removal port 360 and is removed thereby. Remove debris through 360. In another embodiment, the removal may be performed by attaching a vacuum source to the removal port 360 and applying a suction force to the work space WS. Optionally, these two removal methods may be used in combination.

0114Steps 1103, 1104, 1105, and 1106 described above may be performed simultaneously with each other. For example, the tissue removal described in step 1105 may be performed at the same time as the generated debris removal described in step 1106.

0115Optionally, the treatment may be visualized by providing a visualization element within the expanded workspace WS. Such visualization elements include endoscopic cameras or other suitable visualization elements. In one embodiment, the visualization element may be located on the elongated element 310 or on the carrier tube 380. In another embodiment, the visualization element may be inserted separately within the workspace WS.

0116Furthermore, and optionally, the first fluid 330 may be continuously delivered into the body part during treatment to maintain the working space WS. Further, if a sufficient work space WS already exists in the body part before the first fluid 330 is delivered, the first fluid 330 is sent into the body part in order to maintain such a work space WS. May be good.

0117Further, in the examples described above, the second fluid 331 may be combined with a therapeutic agent to treat the surrounding tissue T. Therapeutic agents may be used to minimize discomfort, bleeding in patients and / or to provide topical treatment for cancer, prostatitis, or other illnesses. Therapeutic agents include soluble substances such as salts (eg, salts described above), antibiotics, coagulants, anesthetics, vasoconstrictors, anti-inflammatory agents, chemotherapeutic agents, anticancer agents, other additives or agents, Alternatively, it is considered that a combination thereof is included. Further, the therapeutic agent may be a fixative such as glutaraldehyde, which contracts tissue T to minimize bleeding. Note that glutaraldehyde also helps expand the workspace WS. This is due to the contraction of tissue and the widening of the urethral lumen.

0118The therapeutic agent may be delivered to Tissue T during, before, after, or independently of the tissue resection. If the therapeutic agent is delivered to tissue T during excision, the second fluid 331 in the pressure form described above may be used. When the therapeutic agent is delivered to the tissue T before and / or after the tissue excision or independently of the tissue excision to clean the workspace WS, the pressure of the second fluid 331 is required for the excision of the tissue T. The pressure may be adjusted to be lower than the critical pressure. In such an example, the pressure of the second fluid before and / or after tissue resection is about 0.0703 kg / cm.²~ About 3.515kg / cm²Within the range (about 1 psi to about 50 psi), or in another aspect about 0.703 kg / cm²Lower than (about 10psi). In another aspect, and optionally, the therapeutic agent may be delivered to tissue T using short pulse emissions of the second fluid 331 above the critical pressure. This effectively injects the drug into the tissue T with minimal damage to the tissue T. Depending on the desired treatment, the intensity of such emissions may be determined so that the drug is injected to the appropriate depth within the tissue T.

0119Although the present invention has primarily described transurethral treatment of the prostate, certain embodiments of the above embodiments include brain, heart, lung, intestine, eyeball, skin, kidney, liver, pancreas, stomach, uterus, ovary, testicles. , Other organs such as bladder, ear, nose, bone marrow, adipose tissue, muscle, glandular tissue, soft tissue such as spinal tissue, hard biological tissue such as teeth and bones, sinus and conduit, urethra, colon It can also be used to treat or modify internal organs and passages such as the urethra, bronchi, and blood vessels. The devices disclosed herein may be inserted through existing internal lumens or through hard body tissue. Although preferred embodiments of the present invention have been described in detail above, various modifications, modifications, and equivalents may be used. Therefore, the above description should not be considered to limit the scope of the present invention, and the scope of the present invention is defined by the appended claims.

012010 Prostate Tissue Weight Loss Device 12 shaft 14 Distal end 16 Proximal end 18 hub 20 Energy delivery area 22 Energy source 24 Inflatable fixed balloon 26 Balloon expansion source 28 Injection / flushing source 30 suction (vacuum) source 32 Gas injection source 34 Outgoing port 36 2nd port 38 additional ports B bladder BN bladder neck P prostate U urethra