Peri-vascular tissue ablation catheter with support structures

Abstract

To provide a peri-vascular tissue ablation catheter capable of delivering an ablation liquid for circumferentially damaging tissue in or near an outer layer of a vessel of a human body.SOLUTION: Provided is an intravascular catheter for peri-vascular and / or periurethral tissue ablation includes multiple needles advanced through supported guide tubes which expand with open ends around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, and / or nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. The system also includes means to limit and / or adjust the depth of penetration of the ablative fluid into and beyond the tissue of the vessel wall. The preferred embodiment of the catheter includes structures which provide radial and lateral support to the guide tubes so that the guide tubes open uniformly and maintain their position against the interior surface of the vessel wall as the sharpened injection needles are advanced to penetrate into the vessel wall.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to the treatment of hypertension, congestive heart failure, benign prostatic hyperplasia (BPH) and prostate cancer, as well as other conditions. The invention is in the field of devices for cauterizing tissue and nerve fibers for the treatment of disease. [Background technology]

[0002] Since the 1930s, the method involves destroying or cauterizing the sympathetic nerves in or around the outer layer of the renal artery. It is known that hypertension can be dramatically reduced by using Alcohol has been used for tissue cauterization in the field of endoscopic surgery. rne: "Hemodynamic and natriuretic changes in the denervated kidney in anesthetized and non-anesthetized dogs." "(Am J Physiol, October 1952 171:(1) 148-158) demonstrated that denervation was induced by applying alcohol to the exterior of the renal artery in dogs. It states that this will happen.

[0003] Due to similarities in anatomy, for purposes of this disclosure, the term "target vessel" shall be used herein. The specification also includes the following: hypertension or congestive heart failure (CHF) in the renal arteries, BPH and prostate cancer In this case, it means the urethra.

[0004] A recent technique for renal denervation is the radiofrequency (RF) ablation catheter, St. Jude Medical's Simplicity TM Medtronic and En lightHTN TM and Covidine's One Shot system, Examples of such energy delivery devices include those using high-energy or ultrasonic energy. Current RF ablation techniques for renal artery denervation for the treatment of blood pressure or CHF have potential risks. Short-term complications and long-term sequelae due to applying RF energy from the inside of the renal artery to the renal artery wall are not fully elucidated. This type of energy application and transmural renal artery injury within the renal artery may cause delayed restenosis, thrombosis, renal artery spasm, embolism within the renal parenchyma by fragments, or other problems within the renal artery. In particular, when there are anatomical abnormalities within the renal artery, or atherosclerosis or fibrosis, RF energy may not be delivered uniformly, and sympathetic denervation may be non-uniform or incomplete. In this case, there is a possibility of treatment failure, or the need to cauterize the sympathetic nerves extending to the adventitial surface of the renal artery with a more dangerous level of RF energy. Similar problems can also occur with the use of ultrasound.

[0005] With the Simplicity TM system for RF energy delivery, the sympathetic nerve fibers of the kidney cannot be effectively ablated circumferentially either. Applying circumferential RF energy to the annular portion within the renal artery (applying energy to the intimal surface to destroy the sympathetic nerves outside the adventitial layer) carries an even higher risk of causing renal artery stenosis due to circumferential and transmural thermal injury to the intima, media, and adventitia. Finally, "cauterization" of the inner wall of the renal artery using RF energy is likely to be accompanied by severe pain. Since RF ablation renal denervation requires a long time, the use of sedatives is necessary to control the severe pain caused by repeated cauterization of the vessel wall, and sometimes very high doses of morphine or other opiates, and anesthesia close to general anesthesia are required. This is the case. Therefore, current methods based on RF ablation of the renal sympathetic nerves have many substantial limitations. Similar limitations also exist in ultrasonic or other energy delivery technologies.

[0006] The expandable elastic balloon that expands a single needle towards the inner wall of the blood vessel and is used by Sew ard et al. in U.S. Patents Nos. 6,547,803 and 7,666,163, the Bullfrog® micro-injection catheter, was capable of being used for injecting chemical ablation solutions such as alcohol. However, what these patents neither describe nor predict is that multiple applications were required for circumferential delivery of the ablation substance around the entire circumference of the blood vessel. The maximum number of needles shown by S eward et al. is two, and the two-needle version of Bullfrog® was difficult to miniaturize to fit into the small guide catheter used within the renal artery. When using only one needle, it is extremely difficult to control and precisely rotate all the devices at the end of the catheter, and it is dangerous if the subsequent injections cannot be evenly spaced. This device also cannot accurately control and adjust the delivery depth of the nerve ablation agent. This device also has physical constraints regarding the length of the usable needle, and thus the ability to inject the ablation agent at a suitable depth, particularly into diseased renal arteries with thickened intima, is limited. Another limitation of Bullfrog® is that when the balloon expands within the renal artery, the balloon damages the intima and media of the renal artery, and furthermore causes endothelial cell detachment, which can cause temporary renal ischemia and also the potential for late-onset vascular stenosis. This device also cannot accurately control and adjust the delivery depth of the nerve ablation agent. This device also has physical constraints regarding the length of the usable needle, and thus the ability to inject the ablation agent at a suitable depth, particularly into diseased renal arteries with thickened intima, is limited. Another limitation of Bullfrog® is that when the balloon expands within the renal artery, the balloon damages the intima and media of the renal artery, and furthermore causes endothelial cell detachment, which can cause temporary renal ischemia and also the potential for late-onset vascular stenosis. limitation of Bullfrog® is that when the balloon expands within the renal artery, the balloon damages the intima and media of the renal artery, and furthermore causes endothelial cell detachment, which can cause temporary renal ischemia and also the potential for late-onset vascular stenosis.

[0007] Jacobson and Davis describe in U.S. Patent No. 6,302,870 a catheter for injecting a drug into the inner wall of a blood vessel. The concept of Jacobson et al.'s patent is a plurality of outwardly expanding needles, each having a handle that limits the penetration of the needle into the vessel wall, but the basic design is that a tube having a needle at its distal end rotates and curves outward. In the described design, a small disc-shaped handle is attached in close proximity a short distance from the distal end of the needle, but since its diameter is constant, the overall diameter of the device increases by at least twice the diameter of the handle, and if the diameter of the handle is large enough to prevent the penetration of the needle, the diameter of the device becomes significantly large. By using a handle having a diameter larger than the diameter of the tube, the device becomes large, and since the needle cannot be completely retracted into the hollow shaft through which the needle exits, the needle remains out of the hollow shaft, creating the possibility of accidental needle stick injury. Whether for renal denervation or atrial fibrillation applications, such rotation is difficult because the needle-bearing catheter is long. Also, the handle that limits penetration is at a fixed distance from the distal end of the needle. Even if one wishes to selectively target a specific layer in a certain blood vessel or needs to penetrate significantly beyond the adventitia of the blood vessel in a blood vessel with different wall thicknesses, the penetration depth cannot be adjusted in situ. Jacobson et al. did not envision the use of the injection catheter for denervation. Finally, FIG. 3 of Jacobson et al.'s patent shows a sheath covering an expandable needle without a guide wire, and that sheath, having a released distal end, makes it more difficult to advance through the vasculature. Also, due to the handle, when the needle is fully retracted into the sheath, the needle gets jammed within the sheath and extrusion becomes difficult. ​​​​​​​​ is present.

[0008] As early as 1980, Kline et al. published in "Functional Reinnervation and Expression of Hypersensitivity to Norepinephrine (NE) after Renal Denervation in Rats" (American Physiological Society 1980: 0363 - 6110 / 80 / 0000 - 0000801.25, pp.R353 - R358) that alcohol is shown to be effective in renal denervation in animal models. Kline et al. stated, "To destroy all remaining nerve fibers, 95% alcohol was applied to its vasculature. Using this technique for renal denervation, we found that two weeks after surgery, renal norepinephrine concentrations were depleted by more than 50% (i.e., <10 mg / g tissue).". Again, in the 1983 paper "Effect of Renal Denervation on Arterial Blood Pressure in Aortic Nerve - Cut Rats" (Hypertension, 1983, 5:468 - 475) Kline et al. published again that the 95% alcohol solution applied during surgery was effective in ablating the nerves around the renal artery in rats. Since the 1990s, drug - delivery catheters have been created such as those described by Jacobson et al., which are designed to inject a liquid at multiple points into the arterial wall. McGuckin describes in U.S. Patent No. 7,087,040 a tumor - tissue ablation catheter having three expandable tooth tips for injecting a liquid emerging from a single needle. These tooth tips expand outward and penetrate the tumor tissue. McGuckin's device is as follows.

[0009] McGuckin describes in U.S. Patent No. 7,087,040 a tumor - tissue ablation catheter having three expandable tooth tips for injecting a liquid emerging from a single needle. These tooth tips expand outward and penetrate the tumor tissue. McGuckin's device The distal end is open, and this distal end has sharp teeth to prevent accidental needle pricks. Also, McGuckin's device uses sharp teeth on the outside It is most important that the catheter has sufficient strength to expand and penetrate the tumor tissue. To achieve this strength, the diameter of these tips is 1 mm after injection of fluid for renal denervation. The device must be large enough to cause severe extravascular bleeding when withdrawn. , an effective penetration depth that reliably sets the penetration depth from the tip of the tooth to the distal opening against the inner wall of the vessel; There is no depth limiting mechanism, nor is there any adjustment mechanism to preset the penetration depth. In this case, multiple injections at several depths may be required, resulting in continuous tooth penetration depth. However, for renal denervation, the cautery solution should be continuously adjustable. Injecting too shallow a layer may damage the media of the renal artery, or injecting too deep a layer may cause injury to the outside of the renal artery. The penetration depth was adjusted to avoid missing the nerves in the intramembrane and periambenial layers. The ability to precisely adjust or choose the penetration depth when selecting the device to be used It is important.

[0010] Alcohol has historically been shown to be a useful therapeutic agent for renal denervation, and A., but is adapted for use in nerve cauterization to accommodate variations in vessel wall thickness. In order to address this issue and to take into account the fact that many of the renal artery nerves are located somewhat outside the adventitia of the renal artery, To achieve this, we performed perivascular imaging of sympathetic nerve fibers in the outer layer around the renal artery with adjustable penetration depth. There is a need for an intravascular injection system dedicated to circumferential ablation.

[0011] Throughout this specification, the terms cautery fluid, cautery solution, and / or cautery substance are all often used interchangeably. is used in the same sense to mean a liquid or gaseous substance delivered into the same tissue within the human body with the intent to damage, destroy, or cauterize nerves or tissue within the tissue of it.

[0012] Also, throughout this specification, the term inner wall or inner surface applied to a blood vessel, vascular wall, artery, or arterial wall means the same thing, namely the inner surface of the vascular wall whose inside is the vascular lumen. Also, the term injection outlet is defined as the distal opening within the needle through which the injected liquid exits. For an injection needle, either the injection outlet or the distal opening is used in the same sense in this specification.

[0013] The term "deep" for a structure is defined as beyond or outside of that structure, such that "deep to the adventitia" represents much of the tissue outside the adventitia of an artery.

SUMMARY OF THE INVENTION

PROBLEMS TO BE SOLVED BY THE INVENTION

[0014] Fischell et al. describe in U.S. Patent Application Nos. 13 / 216,495, 13 / 294, 439, and 13 / 342,521 several methods of using expandable needles to deliver a cauterizing fluid to the interior or deep within the inner wall of a target blood vessel. The entireties of these applications are hereby incorporated by reference as part of this specification. The embodiments of Application Nos. 13 / 2 16,495, 13 / 294,439, and 13 / 342,521 come in two types: those in which only the needle expands outward unsupported by any other structure and those having a guide tube that functions as a guiding element to support the needle as it advances within the inner wall of the target blood vessel. The limitations of the needle-only design are that it is small enough to avoid bleeding after vessel penetration ​ When needles are used, such needles may be too fragile to reliably and uniformly expand to the desired position. In one embodiment, the use of strings or wires for connecting the needles to each other provides some assistance in this area. The use of guide tubes as described in Fischell et al.'s application numbers 13 / 294,439 and 13 / 342,521 significantly improves such support. However, whether the unsupported guide tube can be uniformly expanded and preferably positioned at the center of the distal portion of the catheter depends on the shape of the guide tube itself. Without being able to centrally position the catheter as expected and without expanding the guide tube, it is difficult to accurately and reproducibly penetrate the needle to the target depth. Another limitation of the unsupported guide tube is that there is no radial support or "backup" when the injection needle advances through the guide tube. As a result, the guide tube may be pushed away from the inner surface of the vessel wall when the injection needle advances. If the guide tube is made hard enough to be backed up, the distal portion of the catheter may become more rigid, which may limit the delivery ability of the catheter and may cause trauma to the inner wall of the target vessel. If the guide tube is quite flexible, it may be pushed away from the inner surface of the vessel wall and / or may shift radially while the injection needle advances, and / or the injection site may not be symmetrically arranged around the central axis of the target vessel. The use of strings or wires for connecting the needles to each other provides some assistance in this area. The use of guide tubes as described in Fischell et al.'s application numbers 13 / 294,439 and 13 / 342,521 significantly improves such support. However, whether the unsupported guide tube can be uniformly expanded and preferably positioned at the center of the distal portion of the catheter depends on the shape of the guide tube itself. Without being able to centrally position the catheter as expected and without expanding the guide tube, it is difficult to accurately and reproducibly penetrate the needle to the target depth. The use of guide tubes as described in Fischell et al.'s application numbers 13 / 294,439 and 13 / 342,521 significantly improves such support. However, whether the unsupported guide tube can be uniformly expanded and preferably positioned at the center of the distal portion of the catheter depends on the shape of the guide tube itself. Without being able to centrally position the catheter as expected and without expanding the guide tube, it is difficult to accurately and reproducibly penetrate the needle to the target depth. The use of guide tubes as described in Fischell et al.'s application numbers 13 / 294,439 and 13 / 342,521 significantly improves such support. However, whether the unsupported guide tube can be uniformly expanded and preferably positioned at the center of the distal portion of the catheter depends on the shape of the guide tube itself. Without being able to centrally position the catheter as expected and without expanding the guide tube, it is difficult to accurately and reproducibly penetrate the needle to the target depth. The use of guide tubes as described in Fischell et al.'s application numbers 13 / 294,439 and 13 / 342,521 significantly improves such support. However, whether the unsupported guide tube can be uniformly expanded and preferably positioned at the center of the distal portion of the catheter depends on the shape of the guide tube itself. Without being able to centrally position the catheter as expected and without expanding the guide tube, it is difficult to accurately and reproducibly penetrate the needle to the target depth. The use of guide tubes as described in Fischell et al.'s application numbers 13 / 294,439 and 13 / 342,521 significantly improves such support. However, whether the unsupported guide tube can be uniformly expanded and preferably positioned at the center of the distal portion of the catheter depends on the shape of the guide tube itself. Without being able to centrally position the catheter as expected and without expanding the guide tube, it is difficult to accurately and reproducibly penetrate the needle to the target depth. The use of guide tubes as described in Fischell et al.'s application numbers 13 / 294,439 and 13 / 342,521 significantly improves such support. However, whether the unsupported guide tube can be uniformly expanded and preferably positioned at the center of the distal portion of the catheter depends on the shape of the guide tube itself. Without being able to centrally position the catheter as expected and without expanding the guide tube, it is difficult to accurately and reproducibly penetrate the needle to the target depth. The use of guide tubes as described in Fischell et al.'s application numbers 13 / 294,439 and 13 / 342,521 significantly improves such support. However, whether the unsupported guide tube can be uniformly expanded and preferably positioned at the center of the distal portion of the catheter depends on the shape of the guide tube itself. Without being able to centrally position the catheter as expected and without expanding the guide tube, it is difficult to accurately and reproducibly penetrate the needle to the target depth.

[0015] Another limitation of the unsupported guide tube is that there is no radial support or "backup" when the injection needle advances through the guide tube. As a result, the guide tube may be pushed away from the inner surface of the vessel wall when the injection needle advances. If the guide tube is made hard enough to be backed up, the distal portion of the catheter may become more rigid, which may limit the delivery ability of the catheter and may cause trauma to the inner wall of the target vessel. If the guide tube is quite flexible, it may be pushed away from the inner surface of the vessel wall and / or may shift radially while the injection needle advances, and / or the injection site may not be symmetrically arranged around the central axis of the target vessel. Another limitation of the unsupported guide tube is that there is no radial support or "backup" when the injection needle advances through the guide tube. As a result, the guide tube may be pushed away from the inner surface of the vessel wall when the injection needle advances. If the guide tube is made hard enough to be backed up, the distal portion of the catheter may become more rigid, which may limit the delivery ability of the catheter and may cause trauma to the inner wall of the target vessel. If the guide tube is quite flexible, it may be pushed away from the inner surface of the vessel wall and / or may shift radially while the injection needle advances, and / or the injection site may not be symmetrically arranged around the central axis of the target vessel. Another limitation of the unsupported guide tube is that there is no radial support or "backup" when the injection needle advances through the guide tube. As a result, the guide tube may be pushed away from the inner surface of the vessel wall when the injection needle advances. If the guide tube is made hard enough to be backed up, the distal portion of the catheter may become more rigid, which may limit the delivery ability of the catheter and may cause trauma to the inner wall of the target vessel. If the guide tube is quite flexible, it may be pushed away from the inner surface of the vessel wall and / or may shift radially while the injection needle advances, and / or the injection site may not be symmetrically arranged around the central axis of the target vessel. Another limitation of the unsupported guide tube is that there is no radial support or "backup" when the injection needle advances through the guide tube. As a result, the guide tube may be pushed away from the inner surface of the vessel wall when the injection needle advances. If the guide tube is made hard enough to be backed up, the distal portion of the catheter may become more rigid, which may limit the delivery ability of the catheter and may cause trauma to the inner wall of the target vessel. If the guide tube is quite flexible, it may be pushed away from the inner surface of the vessel wall and / or may shift radially while the injection needle advances, and / or the injection site may not be symmetrically arranged around the central axis of the target vessel. Another limitation of the unsupported guide tube is that there is no radial support or "backup" when the injection needle advances through the guide tube. As a result, the guide tube may be pushed away from the inner surface of the vessel wall when the injection needle advances. If the guide tube is made hard enough to be backed up, the distal portion of the catheter may become more rigid, which may limit the delivery ability of the catheter and may cause trauma to the inner wall of the target vessel. If the guide tube is quite flexible, it may be pushed away from the inner surface of the vessel wall and / or may shift radially while the injection needle advances, and / or the injection site may not be symmetrically arranged around the central axis of the target vessel. Another limitation of the unsupported guide tube is that there is no radial support or "backup" when the injection needle advances through the guide tube. As a result, the guide tube may be pushed away from the inner surface of the vessel wall when the injection needle advances. If the guide tube is made hard enough to be backed up, the distal portion of the catheter may become more rigid, which may limit the delivery ability of the catheter and may cause trauma to the inner wall of the target vessel. If the guide tube is quite flexible, it may be pushed away from the inner surface of the vessel wall and / or may shift radially while the injection needle advances, and / or the injection site may not be symmetrically arranged around the central axis of the target vessel. Another limitation of the unsupported guide tube is that there is no radial support or "backup" when the injection needle advances through the guide tube. As a result, the guide tube may be pushed away from the inner surface of the vessel wall when the injection needle advances. If the guide tube is made hard enough to be backed up, the distal portion of the catheter may become more rigid, which may limit the delivery ability of the catheter and may cause trauma to the inner wall of the target vessel. If the guide tube is quite flexible, it may be pushed away from the inner surface of the vessel wall and / or may shift radially while the injection needle advances, and / or the injection site may not be symmetrically arranged around the central axis of the target vessel. Another limitation of the unsupported guide tube is that there is no radial support or "backup" when the injection needle advances through the guide tube. As a result, the guide tube may be pushed away from the inner surface of the vessel wall when the injection needle advances. If the guide tube is made hard enough to be backed up, the distal portion of the catheter may become more rigid, which may limit the delivery ability of the catheter and may cause trauma to the inner wall of the target vessel. If the guide tube is quite flexible, it may be pushed away from the inner surface of the vessel wall and / or may shift radially while the injection needle advances, and / or the injection site may not be symmetrically arranged around the central axis of the target vessel.

Means for Solving the Problems

[0016] This application relates to a perivascular tissue ablation catheter (PTAC) that is located within or on the outer layer of a human blood vessel. A PTA capable of delivering a cauterizing solution for circumferentially damaging tissue located beyond the outer layer discloses C. Cauterization of tissue and nerves using this technique can be accomplished in a shorter time compared to the case of an RF cauterization catheter, and further has the advantage of using only disposable catheters and not requiring other externally installed capital equipment. Also, in this technique, the use of short-acting anesthetics such as Versed is possible, reducing the dosage of the anesthetic and reducing or eliminating the discomfort and pain experienced by the patient during treatment. The main targets for using PTAC are the treatment of hypertension and congestive heart failure by renal denervation, and the treatment of BPH and prostate cancer by cauterizing prostate tissue from a catheter within the urethra. Unlike Bullfrog infusion catheters and current RF ablation devices that function at one or at most two ablation points, the device disclosed in this specification is designed to inject liquid around blood vessels, and can more uniformly circumferentially damage nerves or other "target" tissues while minimizing damage to the inner layer of the blood vessel. In this specification, the term "circumferential delivery" is defined as the simultaneous injection of a suitable cauterizing solution at at least three points within one blood vessel wall, or circumferential injection into the space outside the adventitial layer (outer layer) of one blood vessel. Different from the device of Jacobson et al. in U.S. Patent No. 6,302,870 which does not describe circumferential delivery, the device disclosed in this specification neither depends on the rotation of a tube to cause outward movement nor has a constant-diameter handle to limit penetration. Moreover, in the patent of Jacobson et al., there is a version that retracts within a tubular sheath. Moreover, in the patent of Jacobson et al., there is a version that retracts within a tubular sheath. the discomfort and pain experienced by the patient during treatment.

[0017] The main targets for using PTAC are the treatment of hypertension and congestive heart failure by renal denervation, and the treatment of BPH and prostate cancer by cauterizing prostate tissue from a catheter within the urethra. the treatment of BPH and prostate cancer by cauterizing prostate tissue from a catheter within the urethra.

[0018] Unlike Bullfrog infusion catheters and current RF ablation devices that function at one or at most two ablation points, the device disclosed in this specification is designed to inject liquid around blood vessels, and can more uniformly circumferentially damage nerves or other "target" tissues while minimizing damage to the inner layer of the blood vessel. Unlike Bullfrog infusion catheters and current RF ablation devices that function at one or at most two ablation points, the device disclosed in this specification is designed to inject liquid around blood vessels, and can more uniformly circumferentially damage nerves or other "target" tissues while minimizing damage to the inner layer of the blood vessel. and can more uniformly circumferentially damage nerves or other "target" tissues while minimizing damage to the inner layer of the blood vessel. In this specification, the term "circumferential delivery" is defined as the simultaneous injection of a suitable cauterizing solution at at least three points within one blood vessel wall, or circumferential injection into the space outside the adventitial layer (outer layer) of one blood vessel. In this specification, the term "circumferential delivery" is defined as the simultaneous injection of a suitable cauterizing solution at at least three points within one blood vessel wall, or circumferential injection into the space outside the adventitial layer (outer layer) of one blood vessel. or circumferential injection into the space outside the adventitial layer (outer layer) of one blood vessel. Different from the device of Jacobson et al. in U.S. Patent No. 6,302,870 which does not describe circumferential delivery, the device disclosed in this specification neither depends on the rotation of a tube to cause outward movement nor has a constant-diameter handle to limit penetration. Different from the device of Jacobson et al. in U.S. Patent No. 6,302,870 which does not describe circumferential delivery, the device disclosed in this specification neither depends on the rotation of a tube to cause outward movement nor has a constant-diameter handle to limit penetration. nor has a constant-diameter handle to limit penetration. Moreover, in the patent of Jacobson et al., there is a version that retracts within a tubular sheath. shows a device, the tube has one open end, and Jacobson in the claims of the patent by et al., the liquid flowing in one lumen allows a connecting tube that enables the liquid to exit from the distal end of the catheter through a plurality of needles to be accommodated, it is necessary to increase the diameter. In a preferred embodiment of the present application, since the connecting tube used fits within the lumen of the tube the diameter of the catheter is significantly reduced, making it easier to deliver the catheter to a desired site within the human body to. Specifically, a catheter system that can reproducibly ablate the sympathetic nerves around the renal artery or the tissue around the target vasculature with high efficiency, improving hypertension and other management and treatment, is clearly desired. The most important improvement according to the present disclosure is that a support structure that improves the uniformity and symmetry of the expansion of the guide tubes described in Fischell et al.'s application numbers

[0019] 13 / 294,439 and 13 / 342,521 is added. Also, the support structure of the present application supports the expanded guide tube in the radial (outer) direction when the needle advances through the guide tube into the inner wall of the target vasculature, providing better backup . This type of system also has a significant advantage over other current technologies by enabling reproducible perivascular circumferential ablation of the muscle fibers and conducting tissues near or within the wall of the pulmonary vein ostium to the left atrium of the heart with high efficiency . Such ablation can stop atrial fibrillation (AF) and other arrhythmias. Using the concept of the present application, the prostate tissue outside the prostatic part of the urethra is ablated to treat benign prostatic hyperplasia (BPH) or prostate cancer to.

[0020] It could also be achieved. Other possible applications of this technique can also be revealed from various teachings of this application. be revealed.

[0021] Similar to the previously described application of Fischell et al. regarding the treatment of hypertension, in this application, a small-diameter catheter is disclosed, which includes a plurality of expandable injection tubes having the previous pointed injection needle at its distal end or in the vicinity thereof, and the injection needle advances through a guide tube designed to support and guide the penetration and passage of the injection needle into the inner layer of the target blood vessel. A small-diameter catheter is disclosed. The basic embodiments of the present invention that improve the design of Fischell et al. in US Patent Application No. 13 / 294,439 are of two types. In the first embodiment, through the hollow shaft in the distal part of the PTAC, three or more manually expandable guide tubes are used. Each hollow shaft has a central support part with a shape curved outward from the longitudinal axis of the distal part of the PTAC. This pre-formed curved guide tube advances outward towards the inner surface of the target blood vessel along the hollow shaft. The key point of this design is the support (backup) by the central support part, and when the injection tube with the distal needle advances through the blood vessel wall, the mass of the central catheter body that prevents the guide tube from being pushed away from the inner wall of the target blood vessel. Specifically, the outwardly curved central support part, which is a part of the distal part of the hollow shaft, supports (backs up) as described above. In addition to supporting the guide tube radially, the central support part, together with the opening in the distal end of the hollow shaft, also supports the uniform spacing and lateral stabilization of the guide tube. Fischell et al. in US Patent Application No. 13 / 294,439 are of two types. In the first embodiment, two basic embodiments of the present invention that improve the design of Fischell et al. in US Patent Application No. 13 / 294,439 are of two types. In the first embodiment, three or more manually expandable guide tubes that advance through the hollow shaft in the distal part of the PTAC are used. Each hollow shaft has a central support part with a shape curved outward from the longitudinal axis of the distal part of the PTAC. This pre-formed curved guide tube advances outward towards the inner surface of the target blood vessel along the hollow shaft. The key point of this design is the support (backup) by the central support part, and when the injection tube with the distal needle advances through the blood vessel wall, the mass of the central catheter body that prevents the guide tube from being pushed away from the inner wall of the target blood vessel. Specifically, the outwardly curved central support part, which is a part of the distal part of the hollow shaft, supports (backs up) as described above. In addition to supporting the guide tube radially, the central support part, together with the opening in the distal end of the hollow shaft, also supports the uniform spacing and lateral stabilization of the guide tube. The key point of this design is the support (backup) by the central support part, and when the injection tube with the distal needle advances through the blood vessel wall, the mass of the central catheter body that prevents the guide tube from being pushed away from the inner wall of the target blood vessel. Specifically, the outwardly curved central support part, which is a part of the distal part of the hollow shaft, supports (backs up) as described above. In addition to supporting the guide tube radially, the central support part, together with the opening in the distal end of the hollow shaft, also supports the uniform spacing and lateral stabilization of the guide tube. the mass of the central catheter body that prevents the guide tube from being pushed away from the inner wall of the target blood vessel. Specifically, the outwardly curved central support part, which is a part of the distal part of the hollow shaft, supports (backs up) as described above. In addition to supporting the guide tube radially, the central support part, together with the opening in the distal end of the hollow shaft, also supports the uniform spacing and lateral stabilization of the guide tube. the mass of the central catheter body that prevents the guide tube from being pushed away from the inner wall of the target blood vessel. Specifically, the outwardly curved central support part, which is a part of the distal part of the hollow shaft, supports (backs up) as described above. In addition to supporting the guide tube radially, the central support part, together with the opening in the distal end of the hollow shaft, also supports the uniform spacing and lateral stabilization of the guide tube. the mass of the central catheter body that prevents the guide tube from being pushed away from the inner wall of the target blood vessel. Specifically, the outwardly curved central support part, which is a part of the distal part of the hollow shaft, supports (backs up) as described above. In addition to supporting the guide tube radially, the central support part, together with the opening in the distal end of the hollow shaft, also supports the uniform spacing and lateral stabilization of the guide tube. the mass of the central catheter body that prevents the guide tube from being pushed away from the inner wall of the target blood vessel. Specifically, the outwardly curved central support part, which is a part of the distal part of the hollow shaft, supports (backs up) as described above. In addition to supporting the guide tube radially, the central support part, together with the opening in the distal end of the hollow shaft, also supports the uniform spacing and lateral stabilization of the guide tube. In addition to supporting the guide tube radially, the central support part, together with the opening in the distal end of the hollow shaft, also supports the uniform spacing and lateral stabilization of the guide tube. The uniformity and predictability of the central placement of the device and the engagement position with the inner wall of the target blood vessel and the guide

[0022] tube to Regarding the improvement of the forward speed control when advancing the ID tube, the present application is significantly superior to the application number 13 / 294,439 of Fischell et al.

[0023] The distal portion of the guide catheter used to approach the target vessel (such as the renal artery) is usually not aligned with the longitudinal axis of the target vessel. Therefore, the device disclosed in this specification having an embodiment using three manually expandable guide tubes is advantageous in several different situations. Advantageous.

[0024] When these three guide tubes advance outward, first one contacts the inner wall of the target vessel and as the guide tube further advances outward, the first contacted guide tube pushes the body of the PTAC from the inner wall of the target vessel away and presses it towards the center of the target vessel until the second guide tube contacts the inner wall of the target vessel. Subsequently, the two contacted guide tubes further press the body of the PTAC towards the center of the target vessel until the third guide tube contacts the inner wall of the target vessel. The guide tubes in this specification are not fragile self-expanding structures, and since each has the same expansion diameter around the longitudinal axis of the PTAC, the distal portion of the PTAC will be reproducibly positioned near the true center of the target vessel. The correct central placement of the guide tube is visually confirmed by the fluoroscopic image of the radiopaque marker on the distal portion of the guide tube and can also be confirmed by the contrast agent injected from the guide catheter after the guide tube is deployed. The correct central placement of the guide tube is visually confirmed by the fluoroscopic image of the radiopaque marker on the distal portion of the guide tube and can also be confirmed by the contrast agent injected from the guide catheter after the guide tube is deployed.

[0025] Another important advantage of this system is that the injection tube with the distal injection needle penetrates the target vessel wall The stability of the guide tube and "backup" support during deployment / advancement . When the guide tube engages the inner wall of the target vessel, it is supported by a hollow shaft within the PTAC body . This "backup" of the central catheter ensures that the guide tube remains in place as the injection needle penetrates the inner wall of the target vessel and advances distally to a pre-set penetration depth . Next, the ablation fluid is delivered and the injection needle retracts into the guide tube, and both the guide tube and the injection needle retract into the hollow shaft within the distal portion of the PTAC . In a second embodiment of the invention, which improves on the teachings of Fischell et al., Application No. 13 / 294,439, which uses a self-expanding design, a guide tube attached to an intraluminal centralizing mechanism (ICM) is used . One embodiment of the ICM is an expandable wire cage-like structure that improves the central placement, uniform and symmetric expansion, and radial support (backup) of the guide tube to prevent it from being displaced from the inner wall of the target vessel as it deploys towards the inner wall of the target vessel and the injection needle advances through the target vessel wall

[0026] The ICM is particularly useful when the guide tube with a centralizing ICM is self-expanding . The ICM can also further stabilize and backup a manually expandable guide tube as described in the first embodiment above . The ICM can include specific radiopaque markers that enable visualization when confirming the expanded state of the ICM by fluoroscopy . The ICM can also minimize the distance from the tip of the guide tube to the inner wall of the target vessel to reduce trauma to the inner layer of the target vessel wall by the tip of the guide tube . . . . . . . . .

[0027] In any embodiment of the PTAC disclosed herein, the cauterizing fluid can be injected through the distal end of an injection needle having a distal opening (inlet) at or near its distal end. There is a penetration limiting mechanism, as part of the PTAC, that causes the injection needle to penetrate into or beyond the inner wall of the target vasculature by a pre-set distance. A preferred embodiment of the penetration limiting mechanism is incorporated within the proximal portion of the PTAC and can include means for adjusting the penetration depth. This adjusting means can also include markings that allow for precise adjustment of the penetration depth. Adjustment of the penetration depth by the mechanism within the proximal end of the PTAC can be either under the control of the physician or a pre-setting during device manufacturing. In the previous example, intravascular ultrasound or other imaging techniques can be used to identify the thickness of the renal artery at the desired site where perivascular renal denervation (PVRD) is to be performed. Thereafter, the clinician appropriately adjusts the penetration depth. It is also envisioned to pre-set the PTAC at the factory using a penetration depth adjustment method not available to the clinician, and to provide different product codes that allow for changes in penetration depth when multiple penetration depths are required.

[0028] For example, three penetration depths such as 2 mm or more, 3 mm or more, and 4 mm or more can be utilized. Other advantages of factory adjustment of the penetration depth include easier calibration and the ability to finally adjust at the factory to have a precise penetration depth and provide high-quality products when the manufactured PTACs vary. It is also an advantage that documents seeking approval to use a single or multiple pre-set penetration depths during a clinical trial to suppress the potential mistake of setting an incorrect penetration depth can be submitted to the regulatory authority. Finally, manufacturing and calibration at the factory ​​​​​​​​​​​It is also envisioned to incorporate both internal adjustment and external adjustment by penetration depth marking into the PTAC. It is contemplated.

[0029] Regarding the PTAC disclosed in this specification, the adjustment means can be any one of the following: 1. Pre-set penetration depth adjustment and calibration during device manufacturing. In this case, the product is indicated to have several calibrated penetration depths. 2. Penetration depth adjustment by the device operator before or during the use of the PTAC. This method includes the use of markings on the PTAC indicating the depth at which the cauterizing solution is injected. This method is particularly used for the treatment of BPH and prostate cancer where a series of different penetration depths are desirable to enable delivery of an appropriate amount into the prostate tissue. Ideally, the injection needle should be small enough so that there is substantially no blood loss after the injection tube detaches from the blood vessel wall. A significant advantage over the embodiments taught in Fischell et al.'s U.S. Patent Application No. 13 / 216,495 and Jacobson et al.'s U.S. Patent No. 6,302,870 of the embodiments disclosed in this application is that, due to the structure like the guide tube disclosed in this specification, even a small (<25 gauge) injection needle can be used and the self-expanding structure is not fragile and can reliably penetrate the blood vessel wall. The guide tube with the 1 cm attached disclosed in this specification provides further advantages over the unsupported guide tubes described in Fischell et al.'s U.S. Patent Application Nos. 13 / 294,439 and 13 / 342,521. Another advantage is that the guide tube can be reliably centered within the blood vessel and trauma is reduced when the expanding mechanism contacts the inside of the blood vessel wall. In this case, the product is indicated to have several calibrated penetration depths. 2. Penetration depth adjustment by the device operator before or during the use of the PTAC. This method includes the use of markings on the PTAC indicating the depth at which the cauterizing solution is injected. This method is particularly used for the treatment of BPH and prostate cancer where a series of different penetration depths are desirable to enable delivery of an appropriate amount into the prostate tissue. where a series of different penetration depths are desirable to enable delivery of an appropriate amount into the prostate tissue.

[0030] Ideally, the injection needle should be small enough so that there is substantially no blood loss after the injection tube detaches from the blood vessel wall. The embodiments disclosed in this application of Fischell et al. U.S. Patent Application No. 13 / 216,495 and Jacobson et al.'s U.S. Patent No. 6,302, 870 have a significant advantage over the embodiments taught in the structures like the guide tube disclosed in this specification, even a small (<25 gauge) injection needle can be used and the self-expanding structure is not fragile and can reliably penetrate the blood vessel wall. structures like the guide tube disclosed in this specification, even a small (<25 gauge) injection needle can be used and the self-expanding structure is not fragile and can reliably penetrate the blood vessel wall. The guide tube with the 1 cm attached disclosed in this specification has further advantages over the unsupported guide tubes described in Fischell et al.'s U.S. Patent Application Nos. 13 / 294,439 and 13 / 342,521. Another advantage is that the guide tube can be reliably centered within the blood vessel and trauma is reduced when the expanding mechanism contacts the inside of the blood vessel wall. Yes.

[0031] The guide tubes supported by ICM disclosed in this specification have several different embodiments. Some of the different embodiments are as follows: 1. An expandable structure having a proximal portion, a central portion, and a distal portion, and composed of a single tube or a metal spring ring made of a shape memory alloy such as nitinol. The proximal portion of this structure is a guide tube similar to the guide tubes of US Patent Application Nos. 13 / 294,439 and 13 / 342,521 by Fischell et al. that guide an injection tube having a distal injection needle. The central portion and the distal portion are ICMs. The central portion of this structure has a radiopaque marker and expands to contact the inner wall of the blood vessel to minimize trauma. The expandable distal portion of this structure supports the central portion of the guide tube and the expandable structure and facilitates reproducible expansion. In a preferred embodiment of this structure, the distal portion has high flexibility. The structure in this specification can be self-expanding or can be expanded through the operation of an expansion control mechanism (ECM) at the proximal end of the PTAC, or both if the PTAC has a self-expanding ICM and an ECM that can be used for adjustment or expansion promotion. 2. An expandable structure having a proximal portion, a central portion, and a distal portion, and having a plastic guide tube with an incorporated spring member, and the spring member extends distally from the distal end of the guide tube to form an ICM. Guide tubes similar to the guide tubes of US Patent Application Nos. 13 / 294,439 and 13 / 342,521 by Fischell et al. guide an injection tube having a distal injection needle. This structure may be a guide tube. US Patent Application No. 13 / 294,439 and No. 13 / 342,521. The central portion and the distal portion are ICMs. The central portion of this structure has a radiopaque marker and expands to contact the inner wall of the blood vessel to minimize trauma. The expandable distal portion of this structure supports the central portion of the guide tube and the expandable structure and facilitates reproducible expansion. In a preferred embodiment of this structure, the distal portion has high flexibility. The structure in this specification can be self-expanding or can be expanded through the operation of an expansion control mechanism (ECM) at the proximal end of the PTAC, or both if the PTAC has a self-expanding ICM and an ECM that can be used for adjustment or expansion promotion. 2. An expandable structure having a proximal portion, a central portion, and a distal portion, and having a plastic guide tube with an incorporated spring member, and the spring member extends distally from the distal end of the guide tube to form an ICM. Guide tubes similar to the guide tubes of US Patent Application Nos. 13 / 294,439 and 13 / 342,521 by Fischell et al. guide an injection tube having a distal injection needle. This structure may be a guide tube. The expandable distal portion of this structure supports the central portion of the guide tube and the expandable structure and facilitates reproducible expansion. In a preferred embodiment of this structure, the distal portion has high flexibility. The structure in this specification can be self-expanding or can be expanded through the operation of an expansion control mechanism (ECM) at the proximal end of the PTAC, or both if the PTAC has a self-expanding ICM and an ECM that can be used for adjustment or expansion promotion. 2. An expandable structure having a proximal portion, a central portion, and a distal portion, and having a plastic guide tube with an incorporated spring member, and the spring member extends distally from the distal end of the guide tube to form an ICM. Guide tubes similar to the guide tubes of US Patent Application Nos. 13 / 294,439 and 13 / 342,521 by Fischell et al. guide an injection tube having a distal injection needle. This structure may be a guide tube. In a preferred embodiment of this structure, the distal portion has high flexibility. The structure in this specification can be self-expanding or can be expanded through the operation of an expansion control mechanism (ECM) at the proximal end of the PTAC, or both if the PTAC has a self-expanding ICM and an ECM that can be used for adjustment or expansion promotion. 2. An expandable structure having a proximal portion, a central portion, and a distal portion, and having a plastic guide tube with an incorporated spring member, and the spring member extends distally from the distal end of the guide tube to form an ICM. Guide tubes similar to the guide tubes of US Patent Application Nos. 13 / 294,439 and 13 / 342,521 by Fischell et al. guide an injection tube having a distal injection needle. This structure can be self-expanding or can be expanded through the operation of an expansion control mechanism (ECM) at the proximal end of the PTAC, or both if the PTAC has a self-expanding ICM and an ECM that can be used for adjustment or expansion promotion. 2. An expandable structure having a proximal portion, a central portion, and a distal portion, and having a plastic guide tube with an incorporated spring member, and the spring member extends distally from the distal end of the guide tube to form an ICM. Guide tubes similar to the guide tubes of US Patent Application Nos. 13 / 294,439 and 13 / 342,521 by Fischell et al. guide an injection tube having a distal injection needle. This structure can be both. 3. An expandable structure having a proximal portion, a central portion, and a distal portion, and having a plastic guide tube with an incorporated spring member, and the spring member extends distally from the distal end of the guide tube to form an ICM. Guide tubes similar to the guide tubes of US Patent Application Nos. 13 / 294,439 and 13 / 342,521 by Fischell et al. guide an injection tube having a distal injection needle. This structure may be a guide tube. US Patent Application No. 13 / 294,439 and No. 13 / 342,521. The central portion of the body has a radiopaque marker and expands to contact the inner wall of the blood vessel so as to minimize trauma. The expandable distal portion of this structure supports the central portion of the guide tube and the expandable structure to facilitate reproducible expansion. The structure described herein can be self-expanding, or can be expanded through the operation of an expansion control mechanism (ECM) at the proximal end of the PTAC, or can be both if the PTAC has a self-expanding ICM and an ECM that can be used for adjustment or expansion promotion. 3. A guide tube similar to the guide tubes of US Patent Application Nos. 13 / 294,439 and 13 / 342,521 to Fischell et al., which guides an injection tube having a distal injection needle. This guide tube is attached to the ICM and is formed of an inflatable balloon, and the inflatable balloon expands through the lumen within the hollow shaft of the PTAC. Typically, the injection tube having a distal injection needle in the embodiments disclosed herein has a pre-set curved shape with a radius of curvature similar to that of the guide tube. Therefore, when advancing through the guide tube, the injection tube follows the curvature of the guide tube and does not change the position of the guide tube relative to the inner wall of the target blood vessel. The difference in the radius of curvature of the distal portions of the guide tube and the injection tube should be within ±25%, and ideally within ±10%. After the guide tube expands, it is set to achieve a diameter slightly larger than the maximum diameter of the blood vessel assumed for the use of the device so that it is not restricted by the inner wall of the blood vessel.

[0032]

[0033] ​​​​​​​​​​​​The embodiments are effective in blood vessels having different diameters. When the injection tube extends from the distal end of the guide tube and penetrates through the vessel wall, it is also curved rearward in the proximal direction, which is one of the characteristics of the embodiments of the present application. When the injection tube extends from the distal end of the guide tube and penetrates through the vessel wall, it is also curved rearward in the proximal direction, which is one of the characteristics of the embodiments of the present application. One of the characteristics of the embodiments of the present application.

[0034] Since the penetration depth is preferably accurate, the tube used at either the proximal or distal portion of the PTAC must have limited extensibility so as not to elongate while being deployed within the renal artery through the guide catheter. For example, L605 made of stainless steel or a hypo tube made of nitinol is the best material for the proximal hollow portion of the PTAC. Alternatively, a metal-reinforced tube or a plastic with low extensibility and high durometer hardness can be used. Such a tube is more flexible for the distal portion of the PTAC to travel through a bend that is nearly at a right angle within the guide catheter when the distal portion of the PTAC enters the renal artery from the aorta, and thus is also suitable for the distal portion of the PTAC. Since the penetration depth is preferably accurate, the tube used at either the proximal or distal portion of the PTAC must have limited extensibility so as not to elongate while being deployed within the renal artery through the guide catheter. For example, L605 made of stainless steel or a hypo tube made of nitinol is the best material for the proximal hollow portion of the PTAC. Alternatively, a metal-reinforced tube or a plastic with low extensibility and high durometer hardness can be used. Such a tube is more flexible for the distal portion of the PTAC to travel through a bend that is nearly at a right angle within the guide catheter when the distal portion of the PTAC enters the renal artery from the aorta, and thus is also suitable for the distal portion of the PTAC. Since the penetration depth is preferably accurate, the tube used at either the proximal or distal portion of the PTAC must have limited extensibility so as not to elongate while being deployed within the renal artery through the guide catheter. For example, L605 made of stainless steel or a hypo tube made of nitinol is the best material for the proximal hollow portion of the PTAC. Alternatively, a metal-reinforced tube or a plastic with low extensibility and high durometer hardness can be used. Such a tube is more flexible for the distal portion of the PTAC to travel through a bend that is nearly at a right angle within the guide catheter when the distal portion of the PTAC enters the renal artery from the aorta, and thus is also suitable for the distal portion of the PTAC. Since the penetration depth is preferably accurate, the tube used at either the proximal or distal portion of the PTAC must have limited extensibility so as not to elongate while being deployed within the renal artery through the guide catheter. For example, L605 made of stainless steel or a hypo tube made of nitinol is the best material for the proximal hollow portion of the PTAC. Alternatively, a metal-reinforced tube or a plastic with low extensibility and high durometer hardness can be used. Such a tube is more flexible for the distal portion of the PTAC to travel through a bend that is nearly at a right angle within the guide catheter when the distal portion of the PTAC enters the renal artery from the aorta, and thus is also suitable for the distal portion of the PTAC. Since the penetration depth is preferably accurate, the tube used at either the proximal or distal portion of the PTAC must have limited extensibility so as not to elongate while being deployed within the renal artery through the guide catheter. For example, L605 made of stainless steel or a hypo tube made of nitinol is the best material for the proximal hollow portion of the PTAC. Alternatively, a metal-reinforced tube or a plastic with low extensibility and high durometer hardness can be used. Such a tube is more flexible for the distal portion of the PTAC to travel through a bend that is nearly at a right angle within the guide catheter when the distal portion of the PTAC enters the renal artery from the aorta, and thus is also suitable for the distal portion of the PTAC. Since the penetration depth is preferably accurate, the tube used at either the proximal or distal portion of the PTAC must have limited extensibility so as not to elongate while being deployed within the renal artery through the guide catheter. For example, L605 made of stainless steel or a hypo tube made of nitinol is the best material for the proximal hollow portion of the PTAC. Alternatively, a metal-reinforced tube or a plastic with low extensibility and high durometer hardness can be used. Such a tube is more flexible for the distal portion of the PTAC to travel through a bend that is nearly at a right angle within the guide catheter when the distal portion of the PTAC enters the renal artery from the aorta, and thus is also suitable for the distal portion of the PTAC. Since the penetration depth is preferably accurate, the tube used at either the proximal or distal portion of the PTAC must have limited extensibility so as not to elongate while being deployed within the renal artery through the guide catheter. For example, L605 made of stainless steel or a hypo tube made of nitinol is the best material for the proximal hollow portion of the PTAC. Alternatively, a metal-reinforced tube or a plastic with low extensibility and high durometer hardness can be used. Such a tube is more flexible for the distal portion of the PTAC to travel through a bend that is nearly at a right angle within the guide catheter when the distal portion of the PTAC enters the renal artery from the aorta, and thus is also suitable for the distal portion of the PTAC. Since the penetration depth is preferably accurate, the tube used at either the proximal or distal portion of the PTAC must have limited extensibility so as not to elongate while being deployed within the renal artery through the guide catheter. For example, L605 made of stainless steel or a hypo tube made of nitinol is the best material for the proximal hollow portion of the PTAC. Alternatively, a metal-reinforced tube or a plastic with low extensibility and high durometer hardness can be used. Such a tube is more flexible for the distal portion of the PTAC to travel through a bend that is nearly at a right angle within the guide catheter when the distal portion of the PTAC enters the renal artery from the aorta, and thus is also suitable for the distal portion of the PTAC.

[0035] The injection tube having a distal injection needle is in fluid communication with the injection lumen within the catheter body, and the injection lumen within the catheter body is in fluid communication with the injection port at the proximal end of the PTAC. The injection tube having a distal injection needle is in fluid communication with the injection lumen within the catheter body, and the injection lumen within the catheter body is in fluid communication with the injection port at the proximal end of the PTAC. Typically, such an injection port includes a standard connector such as a Luer connector used for connection to a source of ablation fluid. Similarly, in this specification, the use of a special (proximal side) connector for the injection port can improve safety by preventing accidental injection of ablation fluid from a standard syringe and minimizing the dead space within the catheter when injecting the ablation agent is assumed and described. (It is different from the Luer connector.) Typically, such an injection port includes a standard connector such as a Luer connector used for connection to a source of ablation fluid. Similarly, in this specification, the use of a special (proximal side) connector for the injection port can improve safety by preventing accidental injection of ablation fluid from a standard syringe and minimizing the dead space within the catheter when injecting the ablation agent is assumed and described. (It is different from the Luer connector.) Typically, such an injection port includes a standard connector such as a Luer connector used for connection to a source of ablation fluid. Similarly, in this specification, the use of a special (proximal side) connector for the injection port can improve safety by preventing accidental injection of ablation fluid from a standard syringe and minimizing the dead space within the catheter when injecting the ablation agent is assumed and described. (It is different from the Luer connector.) Typically, such an injection port includes a standard connector such as a Luer connector used for connection to a source of ablation fluid. Similarly, in this specification, the use of a special (proximal side) connector for the injection port can improve safety by preventing accidental injection of ablation fluid from a standard syringe and minimizing the dead space within the catheter when injecting the ablation agent is assumed and described. (It is different from the Luer connector.) Typically, such an injection port includes a standard connector such as a Luer connector used for connection to a source of ablation fluid. Similarly, in this specification, the use of a special (proximal side) connector for the injection port can improve safety by preventing accidental injection of ablation fluid from a standard syringe and minimizing the dead space within the catheter when injecting the ablation agent is assumed and described. (It is different from the Luer connector.)

[0036] In this injection system, even when targeting many tissues in the adventitial layer of the aorta, pulmonary vein, or renal artery, or the prostatic part of the urinary tract, or deep within them, the use of a very small gauge (less than 25 gauge) needle that penetrates the arterial wall is assumed to be safe. It is also assumed that the distal needle can be a bevel needle or a round needle, and when using a bevel needle, the injection outlet / distal opening can be a small discharge port (pore) provided on the proximal side surface of the bevel tip of the injection tube or the distal needle. At least two injection tubes are required, but depending on the diameter of the vessel to be treated and the diffusion ability of the ablation solution within the perivascular space of the vessel, three to eight injection tubes may be more appropriate. For example, three or four injection tubes are required for a renal artery with a diameter of 5 mm, while five to six injection tubes are required for a renal artery with a diameter of 8 mm. In this injection system, even when targeting many tissues in the adventitial layer of the aorta, pulmonary vein, or renal artery, or the prostatic part of the urinary tract, or deep within them, the use of a very small gauge (less than 25 gauge) needle that penetrates the arterial wall is assumed to be safe. The use of a very small gauge (less than 25 gauge) needle that penetrates the arterial wall is also assumed to be safe. The distal needle can be a bevel needle or a round needle, and when using a bevel needle, the injection outlet / distal opening can be a small discharge port (pore) provided on the proximal side surface of the bevel tip of the injection tube or the distal needle. The use of a very small gauge (less than 25 gauge) needle that penetrates the arterial wall is also assumed to be safe. The distal needle can be a bevel needle or a round needle, and when using a bevel needle, the injection outlet / distal opening can be a small discharge port (pore) provided on the proximal side surface of the bevel tip of the injection tube or the distal needle. The use of a very small gauge (less than 25 gauge) needle that penetrates the arterial wall is also assumed to be safe. The distal needle can be a bevel needle or a round needle, and when using a bevel needle, the injection outlet / distal opening can be a small discharge port (pore) provided on the proximal side surface of the bevel tip of the injection tube or the distal needle. At least two injection tubes are required, but depending on the diameter of the vessel to be treated and the diffusion ability of the ablation solution within the perivascular space of the vessel, three to eight injection tubes may be more appropriate. For example, three or four injection tubes are required for a renal artery with a diameter of 5 mm, while five to six injection tubes are required for a renal artery with a diameter of 8 mm. At least two injection tubes are required, but depending on the diameter of the vessel to be treated and the diffusion ability of the ablation solution within the perivascular space of the vessel, three to eight injection tubes may be more appropriate. For example, three or four injection tubes are required for a renal artery with a diameter of 5 mm, while five to six injection tubes are required for a renal artery with a diameter of 8 mm. At least two injection tubes are required, but depending on the diameter of the vessel to be treated and the diffusion ability of the ablation solution within the perivascular space of the vessel, three to eight injection tubes may be more appropriate. For example, three or four injection tubes are required for a renal artery with a diameter of 5 mm, while five to six injection tubes are required for a renal artery with a diameter of 8 mm. At least two injection tubes are required, but depending on the diameter of the vessel to be treated and the diffusion ability of the ablation solution within the perivascular space of the vessel, three to eight injection tubes may be more appropriate. For example, three or four injection tubes are required for a renal artery with a diameter of 5 mm, while five to six injection tubes are required for a renal artery with a diameter of 8 mm. At least two injection tubes are required, but depending on the diameter of the vessel to be treated and the diffusion ability of the ablation solution within the perivascular space of the vessel, three to eight injection tubes may be more appropriate. For example, three or four injection tubes are required for a renal artery with a diameter of 5 mm, while five to six injection tubes are required for a renal artery with a diameter of 8 mm.

[0037] In a preferred embodiment of the present disclosure, ethanol is used as the ablation solution because it is hydrophilic and lipophilic and rapidly diffuses within the perivascular space. Therefore, only three needles are required for the circumferential delivery of ethanol, and the diameter of the device can be reduced. It is also assumed that adding ethanol or other alcohol to another neurotoxin agent will accelerate the diffusion of the ablation agent within the perivascular space. In a preferred embodiment of the present disclosure, ethanol is used as the ablation solution because it is hydrophilic and lipophilic and rapidly diffuses within the perivascular space. Therefore, only three needles are required for the circumferential delivery of ethanol, and the diameter of the device can be reduced. In a preferred embodiment of the present disclosure, ethanol is used as the ablation solution because it is hydrophilic and lipophilic and rapidly diffuses within the perivascular space. Therefore, only three needles are required for the circumferential delivery of ethanol, and the diameter of the device can be reduced. In a preferred embodiment of the present disclosure, ethanol is used as the ablation solution because it is hydrophilic and lipophilic and rapidly diffuses within the perivascular space. Therefore, only three needles are required for the circumferential delivery of ethanol, and the diameter of the device can be reduced. It is also assumed that adding ethanol or other alcohol to another neurotoxin agent will accelerate the diffusion of the ablation agent within the perivascular space. In a preferred embodiment of the present disclosure, ethanol is used as the ablation solution because it is hydrophilic and lipophilic and rapidly diffuses within the perivascular space. Therefore, only three needles are required for the circumferential delivery of ethanol, and the diameter of the device can be reduced. It is also assumed that adding ethanol or other alcohol to another neurotoxin agent will accelerate the diffusion of the ablation agent within the perivascular space.

[0038] Typically, embodiments of the self-expanding PTAC disclosed herein include a hollow, thin-walled sheath that houses the guide tube and ICM prior to deployment during the transition from treating one renal artery to treating another renal artery and during removal from the human body. This sheath is for PTA Typically, embodiments of the self-expanding PTAC disclosed herein include a hollow, thin-walled sheath that houses the guide tube and ICM prior to deployment during the transition from treating one renal artery to treating another renal artery and during removal from the human body. Typically, embodiments of the self-expanding PTAC disclosed herein include a hollow, thin-walled sheath that houses the guide tube and ICM prior to deployment during the transition from treating one renal artery to treating another renal artery and during removal from the human body. It also enables easy insertion into the guide catheter or introducer sheath at the distal end of C. This sheath can also protect the operator from accidental needle sticks and blood - borne pathogens when the PTAC is removed from the patient's body at the end of the treatment procedure. Usually, this sheath contains radiopaque markers located near the distal end of the sheath to inform the operator of its position under fluoroscopy.

[0039] The entire PTAC is designed to advance over a guide wire, either in a configuration that includes a fixed distal guide wire or an over - the - wire configuration where the lumen of the guide wire extends the full length of the PTAC, or a rapid - exchange configuration where the guide wire exits at least 10 cm proximal to the distal end of the PTAC from the catheter body and the proximal portion of the guide wire extends outside the catheter shaft. For some applications, it is also envisioned to use a flexible and tapered distal tip without a distal guide wire.

[0040] The version with a fixed guide wire or the version with a flexible and tapered distal tip without a distal guide wire is a preferred embodiment because it has a minimum distal diameter. Only the proximal side of the fixed guide wire is the thin distal portion of the PTAC called the occlusion section. The occlusion section serves the following purposes in the design of the PTAC. 1. The occlusion section is a thin - walled, flexible member that increases in diameter from the portion of the thin - diameter, fixed distal guide wire to enable the PTAC to smoothly progress through bends, such as the bend when the PTAC enters the renal artery from the aorta through a small hole within the guide catheter. ​​​​​​​​​​​​​2. The proximal part of the occlusion section is expandable with the PTAC system including the guide tube and ICM. The sheath is mated with the above-mentioned sheath to completely surround and restrain the injection needle in the desired area. 3. Usually, the occlusion site requires the surgeon to see the position of the obturator and the position of the occlusion site relative to the sheath. The present invention includes a radiopaque marker that can be used to 4. In some applications, including renal denervation, this device can be used without a fixed distal guidewire. It is envisioned that the closure will be tapered and flexible to allow safe advancement of the vice.

[0041] Fluoroscopic visualization of the correct deployment of the guide tube and injection needle is essential. There are several ways in which this goal can be achieved. Tantalum or tungsten is used for clear visualization of the needle, guide tube, and injection tube. The catheter may be made of a radiopaque material such as zinc or coated with a radiopaque material such as gold or platinum. However, the preferred method is to use a radiopaque marker. A Kerr band is placed near the distal end of each guide tube, and a radiopaque wire is inserted into each injection tube. The goal is to contain a radiopaque wire within the lumen of each infusion tube. In addition to providing better visualization, the yar reduces the volume or dead space within the infusion tube, Reduces the amount of fluid required to flush the inside of the PTAC.

[0042] One of the electrodes is also designed to function as a diagnostic needle to assess electrical activity in that area of ​​the vascular wall. Alternatively, it is contemplated that multiple injection needles may be in electrical communication with the proximal end of the PTAC. .

[0043] An electric current or RF energy source is used to deliver electrical current or RF energy to cauterize tissue and / or nerves. It is also envisioned that the source or RF source can be provided with two or more expandable legs.

[0044] To optimize the permanent disruption (neurotomy) of the sympathetic nerves in a portion of the renal artery, this device can also inject one or more neuroablative substances simultaneously or sequentially, which is also envisioned. Envisioned neurotoxic substances that can be used include ethanol, phenol, gly cerol, relatively high concentrations of local anesthetics (e.g., lidocaine, or other agents such as bupivacaine, tet racaine, benzocaine, etc.), antiarrhythmic drugs with neurotoxicity, botulinum toxin , digoxin or other cardiac glycosides, guanethidine, heated liquids including heated saline, hypertonic saline, hypotonic liquids, KCl, or the above-mentioned heated neurotoxic substances, but are not limited thereto.

[0045] It is also envisioned that the ablative substance can be a hypertonic liquid such as (salty) hypertonic saline or a hypotonic liquid such as distilled water. These agents cause permanent damage to the nerves and can function as well as alcohol or certain neurotoxins. These agents can be injected at high temperature, low temperature, or even at room temperature. If distilled water, hypotonic saline, or hypertonic saline is used with an injection volume of less than 1 mL, one step of the PTAC usage procedure can be omitted. This is because a small amount of these liquids is not harmful to the kidney, eliminating the need to completely flush the ablative liquid from the PTAC with saline to prevent the ablative liquid from entering the renal artery during catheter withdrawal. For this reason, when using a more toxic ablative liquid, two liquid injections per artery are required, whereas when using distilled water or the like, only one injection is required. It will only require liquid injection.

[0046] PTAC is also envisioned to deliver a hot liquid to cauterize or damage the target tissue or nerve. It is also envisioned to connect the catheter to a source of heated liquid or its vapor. The heated liquid can be saline, hypertonic solution, hypotonic solution, alcohol, phenol, lidocaine, or some other combination of liquids. To thermally cauterize the target tissue or nerve at and around the needle injection site, heated or vaporized saline, hypertonic saline, hypotonic saline, ethanol, distilled water, or other liquids can also be injected through the injection needle.

[0047] In the present disclosure, the use of anesthetic agents such as lidocaine that can relieve any pain caused by denervation when first injected, or mixed and injected with the cauterizing solution, or co-injected with the cauterizing solution is also envisioned.

[0048] Before advancing the injection needle or injection tube, the thickness and structure of the target vessel wall (e.g., renal artery) are accurately measured, and imaging techniques such as multislice CT scan, MRI, intravascular ultrasound (IVUS), or optical coherence tomography (OCT) are also envisioned to enable grasping and setting the accurate and appropriate injection depth of the cauterizing agent. Using IVUS prior to the use of PTAC is particularly useful for setting the target accurate injection depth. Subsequently, this accurate injection depth that has been set can be aimed for by utilizing adjustable penetration depth characteristics or selecting a suitable PTAC having a preset penetration depth for delivering the cauterizing solution. During manufacturing, different product codes are displayed on the package label according to the penetration depth. ​​​​​​​​​​

[0049] For use in renal sympathetic denervation, the preferred manually expandable ( "push-type") PTAC guide tube is used in the following steps (each step is not mandatory and can be shortened or modified as would be apparent to one skilled in the art): 1. Administer sedatives to the patient using standard techniques for cardiac catheters or septal ablation, such as alcohol septal ablation (using skilled analgesics and narcotic analgesics). 2. Engage the first renal artery with a guiding catheter placed via the femoral artery or radial artery using standard arterial access methods. 3. After flushing all lumens, including the injection lumen of the PTAC, advance the distal end of the PTAC into the guiding catheter with a fixed distal guide wire. Advance the distal portion of the PTAC through the distal end of the guiding catheter until the radiopaque marker on the occluder or guide tube reaches the desired position within the renal artery. 4. Manually advance the guide tube outside the hollow shaft using the mechanism within the proximal portion of the PTAC until the guide tube is fully expanded, aiming at the inner wall of the target vessel. Visualize the radiopaque tip of the guide tube to confirm expansion of the guide tube. 5. Then, coaxially advance an injection tube / injection needle through the Inject. In this way, the injection tube / injection needle is arranged to deliver the neurolytic agent to the adventitial surface or the "deep part" (outside the adventitial surface). When the depth from the IEL is 2 mm to 4 mm, the damage to the intima and media of the renal artery is minimized. The normal thickness of the media in the renal artery is 0.5 mm to 0.8 mm. In the embodiments of the penetration depth limiting characteristics disclosed in the present application, the injection needle arranged at a certain distance from the distal end of the guide tube has a distal opening. In a normal renal artery, the guide tube is usually located close to the IEL located on or near the inner wall of the target vessel. When it is determined from angiography, IVUS, or OCT that the intima is thickened due to plaque or neointimal hyperplasia in the renal artery, a penetration depth of 3 mm to 6 mm is required from the distal end of the guide tube. It is envisioned that an operator using a specific product code (i.e., a pre-set product) with a larger pre-set penetration depth or a mechanism within the handle of the PTAC can make corresponding adjustments easily. When there is stenosis in the vessel, it is desirable to inject at a site away from the stenotic site and, if necessary, treat the stenosis by percutaneous coronary angioplasty (PCI). When the depth from the IEL is 2 mm to 4 mm, the damage to the intima and media of the renal artery is minimized. The normal thickness of the media in the renal artery is 0.5 mm or 0.8 mm. In the embodiments of the penetration depth limiting characteristics disclosed in the present application, the injection needle arranged at a certain distance from the distal end of the guide tube has a distal opening. In a normal renal artery, the guide tube is usually located close to the IEL located on or near the inner wall of the target vessel. When it is determined from angiography, IVUS, or OCT that the intima is thickened due to plaque or neointimal hyperplasia in the renal artery, a penetration depth of 3 mm to 6 mm is required from the distal end of the guide tube. A specific product code (i.e., a pre-set product) with a larger pre-set penetration depth or a mechanism within the handle of the PTAC can make corresponding adjustments easily. When there is stenosis in the vessel, it is desirable to inject at a site away from the stenotic site and, if necessary, treat the stenosis by percutaneous coronary angioplasty (PCI). When there is stenosis in the vessel, it is desirable to inject at a site away from the stenotic site and, if necessary, treat the stenosis by percutaneous coronary angioplasty (PCI). 6. Inject an appropriate amount of a cauterizing agent, which can be a cauterizing fluid such as ethanol (ethyl alcohol), distilled water, hypertonic saline, hypotonic saline, phenol, glycerol, lidocaine, bupivacaine, tetracaine, benzocaine, procaine, botulinum toxin, glycoside, or any suitable neurotoxic fluid. For this injection, two or more combinations of neurolytic fluids or local anesthetics are injected together or continuously into the space within the vessel wall and / or immediately outside the vessel (with the local anesthetic that reduces discomfort first, followed by delivering the cauterizing agent). ​​​​​​​​​) and / or a high-temperature liquid (or steam), or a very low-temperature (for cryoablation) liquid can be injected It may be included. The normal injection volume is 0.1 mL to 3.0 mL. Thereby, intersecting A plurality of ablation regions (one for each injection tube / injection needle) that form an ablation ring around the circumference of the target vessel are generated. During either the test injection before nerve ablation agent injection or the treatment injection A contrast agent that enables visualization of the ablation region by X-ray can be added. When using ethanol as the ablation agent, an amount less than 0.5 mL is sufficient. This is because not only is the necessary space containing the sympathetic nerve completely filled, but also the amount is small enough that it will not damage the patient's kidneys even if accidentally released into the renal artery Ideally, 0.1 mL to 0.3 mL of ethanol is used. 7. Inject physiological saline into the PTAC to completely flush out the ablation agent from the injection lumen (dead space) of the PTAC including the injection tube with the distal injection needle. By doing so, it is prevented that the ablation agent accidentally enters the renal artery while the injection needle retracts into the PTAC. Such An accidental release into the renal artery may cause kidney damage. When using distilled water, hypotonic saline water, or hypertonic saline as the ablation agent, or when the amount of the ablation agent is small and the possibility of kidney damage due to accidental release into the renal artery is low, this washing step can be omitted 8. Retract the injection tube / injection needle of the PTAC into the guide tube. 9. Retract the guide tube into the hollow shaft of the PTAC. 10. Optionally, rotate the PTAC by 30° to 90°, or move the PTAC 0.2 cm to 4 cm distally or proximally from the initial injection site. If necessary, repeat the injection to create a second tissue damage ring to expand the denervation / neuroablation. 11. Repeat the same method for each of the above steps to ablate the tissue in the renal artery on the opposite side (the side of the body opposite). 12. Withdraw the PTAC completely from the guide catheter. 13. Remove all remaining equipment from the patient's body.

[0050] A simplified version of the above procedure is as follows, without flushing the injection lumen / dead space of the catheter with saline: 1. Administer sedatives to the patient (using sophisticated analgesics and narcotic analgesics) using standard techniques for cardiac catheters or septal ablation, similar to alcohol septal ablation. 2. Place the first renal artery via the femoral artery or radial artery using standard arterial access methods, and engage it with a guide catheter whose distal end has entered beyond the small hole of the renal artery. 3. Outside the patient's body, flush the injection lumen with ablation solution with the needle guidance element / guide tube and injection needle fully expanded. 4. Outside the patient's body, flush the entire lumen of the PTAC except the injection lumen with saline. Flow a sufficient amount of saline from the guide tube and the distal opening of the catheter to wash away the remaining ablation solution from the outer surface of the PTAC. 5. Withdraw the injection needle and the needle guidance element / guide tube. 6. Advance the PTAC through the guide catheter to the desired point in the renal artery. ​​​​​​​​​​​7. Manually advance the needle guiding element / guide tube. 8. Next, advance the injection tube / injection needle through the inner elastic membrane (IEL) to the desired depth. 9. Inject a suitable amount of ablation agent / ablation solution. 10. Retract the injection tube / injection needle of the PTAC into the guide tube. 11. Retract the guide tube into the hollow shaft of the PTAC. 12. Retract the PTAC into the guide catheter. 13. Optionally, move the guide catheter to the opposite renal artery (present on the opposite side of the body). 14. Repeat steps 6 to 11. 15. Completely remove the PTAC from the guide catheter. 16. Remove all remaining devices from the patient's body.

[0051] The amount of ablation solution that may leak from the retracting injection needle is significantly smaller than the volume of the dead space within the PTAC, so this simplified procedure is safe. Specifically, up to 0.5 mL of ablation solution such as ethanol can be safely injected into the renal artery without causing kidney damage. Moreover, even if its entire volume leaks into the renal artery, since the dead space is less than 0.3 mL, the kidney will not be damaged. Currently, less than 10% of the internal volume (i.e., less than 0.03 mL) may leak from the closed PTAC, so the above simplified procedure is very safe.

[0052] For use in renal sympathetic denervation, the PTAC having the ICM disclosed herein is used in the following procedure (each step is not essential and can be shortened or modified as would be understood by a person skilled in the art): 1. Administer a sedative to the patient (using sophisticated analgesics and narcotic analgesics) using standard techniques for cardiac catheters or septal ablation, similar to alcohol septal ablation and the like. 2. Engage the first renal artery with a guiding catheter placed via the femoral artery or radial artery using standard arterial access techniques. 3. After flushing all lumens, including the injection lumen of the PTAC, with saline, advance the distal end of the PTAC, which is in its closed position, into the guiding catheter. Advance the distal portion of the PTAC through the distal end of the guiding catheter until the radiopaque marker on the ICM or guiding tube reaches the desired position within the renal artery. 4. Withdraw the sheath to allow the expandable guiding tube with ICM to be deployed towards the inner wall of the renal artery. If the ICM is self-expanding, this deployment is automatic, and if the expansion is controlled by a distal expansion control mechanism (ECM), the operator manipulates to expand the ICM and guiding tube. Visualize the radiopaque tip of the guiding tube and / or the radiopaque marker on the ICM to confirm the expansion. 5. Then, coaxially advance an injection tube / injection needle through the guiding tube, penetrate the renal artery, pass through the internal elastic membrane (IEL), and deliver a neuroablative agent to the deep part of the adventitial surface, advancing it into the outer layer (adventitia and / or periadventitial layer) of the renal artery wall at a preset distance (usually 0.5 mm to 4 mm, preferably 2 mm to 4 mm) away from the IEL. When at a depth of 2 mm to 4 mm from the IEL, damage to the intima and media of the renal artery is minimized. 6. Ethanol (ethyl alcohol), distilled water, hypertonic saline, hypotonic saline, f Ethanol, glycerol, lidocaine, bupivacaine, tetracaine, benzocaine, guanethidine, botulinum toxin, glycosides, or any suitable neurotoxic fluid, etc. as a cauterizing fluid Inject an appropriate amount of a suitable cauterizing agent, such as a cauterizing fluid of botulinum toxin, glycosides, or any suitable neurotoxic fluid. For this injection, a combination of two or more neurocauterizing fluids or local anesthetics can be injected together or sequentially (with the local anesthetic that reduces discomfort first and then delivering the cauterizing agent) into the space within and / or just outside the vessel wall, and / or a high-temperature fluid (or steam), or a very low-temperature (for cryoablation) liquid can be included. The normal injection volume is 0.1 mL to 5 mL. This forms a cauterizing ring around the circumference of the target vessel, generating a plurality of cauterizing regions (one for each injection tube / injection needle). During either the test injection before the neurocauterizing agent injection or the therapeutic injection, a contrast agent can be added to enable visualization of the cauterizing region by X-ray. When using ethanol as the cauterizing agent, an amount less than 0.5 mL is sufficient. This is because not only is the necessary space including the sympathetic nerve completely filled, but also the amount is small enough not to damage the patient's kidney even if it is accidentally released into the renal artery. Ideally, 0.1 mL to 0.3 mL of ethanol is used. Inject physiological saline into the PTAC to completely flush out the cauterizing agent from the injection lumen (dead space) of the PTAC including the injection tube with the distal injection needle. By doing this, it is prevented that the cauterizing agent accidentally enters the renal artery while the injection needle is retracting within the PTAC. Such an accidental release into the renal artery may cause kidney damage. When using distilled water, hypotonic saline, or hypertonic saline as the cauterizing agent, or when the amount of the cauterizing agent is small and the renal artery ​​​​​​​​​​​​​​​If the risk of kidney damage due to accidental release into the artery is low, this washing step can be omitted. It can be omitted. 8. Retract the injection tube / injection needle of the PTAC into the guide tube. Then, retract the guide tube with the ICM and return it under the sheath to completely enclose the sharp-tipped injection needle at the tip. Then, pull the entire PTAC back into the guide catheter. 9. In some cases, rotate the PTAC by 30° to 90°, or move the PTAC 0.2 cm to 4 cm distally or proximally relative to the initial injection site. If necessary, repeat the injection to create a second tissue damage ring to expand the denervation / neuroablation. 10. Repeat the same method for each of the above steps to ablate the tissue in the artery of the opposite (on the opposite side of the body) kidney. 11. Completely withdraw the PTAC from the guide catheter. 12. Remove all remaining devices from the patient's body.

[0053] In both embodiments of the present application, as described in the above method, means for restricting penetration of the injection needle into the blood vessel wall are included within the proximal portion of the PTAC. One or more handles are envisioned that the operator uses to first cause expansion of the guide tube and then cause advancement of the injection needle. Reversing the operation of these mechanisms causes the injection needle to retract into the guide tube, after which the guide tube retracts into the catheter body or under the sheath. Fischell et al. describe control mechanisms for the forward and backward movement of distal structures such as a sheath, a guide tube with a distal injection needle, and an injection tube in U.S. Patent Application Nos. 13 / 643,070, 13 / 643,066, and 13 / 643,065. Accidental An interlocking device and a locking mechanism for preventing out-of-procedure movement are also described.

[0054] Also, Fischell et al. describe a proximal portion having ports for flushing and ablation fluid injection. The embodiments disclosed in the present application have a similar structure and control mechanism in the proximal portion. Typically, there are three concentric tubes in the middle portion of the catheter. In the manually expandable embodiment using a hollow shaft, there is an outer tube forming the body of the catheter. The intermediate tube controls the forward and backward movement of the guide tube, and the inner tube controls the forward and backward movement of the injection tube having a distal injection needle. The lumen of the inner tube also transports the ablation fluid injected into the injection port in the proximal portion of the PTAC to the lumen of the injection tube and the injection needle, and finally out through the distal end of the injection needle or a distal opening in its vicinity.

[0055] Another important feature of the PTAC disclosed herein is the internal volume of the PTAC ("dead space") is designed to reduce the amount of saline required to flush the ablation fluid from the catheter into as many tissues as desired. For the implementation of perivascular renal denervation (PVRD), less than 0. 5 mL of ablation fluid such as ethanol is assumed to be required. The dead space must be less than 0.5 mL and ideally should be less than 0.2 mL. It is assumed that the dead space can be reduced to less than 0.1 mL by some design features. Such features include the use of a small-diameter hypo tube with an inner diameter of less than 0.5 mm as the inner tube used for fluid injection in the PTAC. The hypo tube reduces the internal volume of the hypo tube and, as a result, is arranged inside over the entire length of the hypo tube / inner tube to reduce the dead space of the PTAC. whether it includes a wire to be placed, and / or with an inner diameter of less than 0.5 mm and a length of less than 2 cm and reducing the volume of the injection connection tube at the proximal injection port and / or the proximal end of the PTAC is designed to be suppressed.

[0056] It is an important feature of the present invention that the guide tube is a needle guiding element for an injection needle that is retractable and has a very thin wall thickness. Specifically, the prior art of Jacobson et al. describes a curved needle that advances outward from the central catheter in order to penetrate the inner wall of the target vessel. In the prior art, there is no coverage for the needle that advances from the distal end or side surface of the catheter. Without guidance (support ) during advancement, and generally, a needle that is not thick enough to cause bleeding after retraction from the arterial wall is too fragile and cannot reliably penetrate into the vessel wall as desired. Therefore, an important aspect of the embodiments disclosed in the present application is to include a needle guiding element such as a guide tube that enables a very thin injection needle to reliably advance to the desired depth within the inner wall of the target vessel. Such a guiding element does not need to be a tube, nor does it need to have a round cross-section, and may be a semi-tube or a partial tube, and may have a structure with a groove for guiding the retractable needle . The guiding structure may be some expandable structure such as a spring that expands outward, supports radially, and guides the needle. The term "expand" means the movement of the structure from a first position relatively close to the longitudinal axis of the catheter to a second position relatively far from the longitudinal axis at least, and the movement may be due to expansion, deflection, rotational movement, or other mechanisms . It is desirable for the needle guiding element to expand outward from the central catheter. not necessary, nor does it need to have a round cross-section, and may be a semi-tube or a partial tube, and may have a structure with a groove for guiding the retractable needle and may be a structure having a groove for guiding the retractable needle, and the guiding structure may be some expandable structure such as a spring that expands outward, supports radially, and guides the needle. The term "expand" means the movement of the structure from a first position relatively close to the longitudinal axis of the catheter to a second position relatively far from the longitudinal axis at least, and the movement may be due to expansion, deflection, rotational movement, or other mechanisms . The term "expand" means the movement of the structure from a first position relatively close to the longitudinal axis of the catheter to a second position relatively far from the longitudinal axis at least, and the movement may be due to expansion, deflection, rotational movement, or other mechanisms from a first position relatively close to the longitudinal axis of the catheter to a second position relatively far from the longitudinal axis at least, and the movement may be due to expansion, deflection, rotational movement, or other mechanisms and may be due to expansion, deflection, rotational movement, or other mechanisms. It is desirable for the needle guiding element to expand outward from the central catheter.

[0057] What is unique about the embodiments disclosed in this application is that another structure that supports the needle guiding element in the radial and lateral directions is also used. The use of another structure is important because a uniform penetration and angular spread of multiple needles is required . Also, since the needle advances and is guided by a "guiding element" (e.g., a guide tube), the guiding element can also be retracted from a desired position towards the inner wall of the blood vessel while the needle is not supported . For this reason, the present disclosure teaches the design of a structure that supports ( "backs up") the needle guiding element radially so that the needle guiding element does not retract from the inner surface when the needle advances into the blood vessel wall .

[0058] In another embodiment of the present disclosure, the structure is simplified by combining the guide tube and the injection tube within a single injection tube . This also reduces the number of steps in the operation . Specifically, the injection needle is permanently attached inside the injection tube that advances and retracts through a hollow shaft. The diameter of the distal end of the injection tube is larger than the diameter of the injection needle and functions as a "plug" that limits the penetration of the injection needle into the inner wall of the target blood vessel .

[0059] In yet another embodiment of the present disclosure, an expandable balloon is used to expand a guide tube that passes through an injection tube and has a distal needle that advances into the inner wall of the target blood vessel . This balloon may be flexible, semi-flexible, or non-flexible. However, a stretchable and flexible balloon is preferred so that the diameter of the outer edge of the expanded guide tube can be easily set by varying the inflation pressure of the balloon . By attaching the guide tube outside the balloon, the structure becomes simpler compared to the case where the guide tube is disposed within the balloon, and the distal end of the guide tube ​​​The distal end is engageable with the inner wall of the target vasculature such that the surface of the balloon contacts the inner wall of the target vasculature without. When the balloon contacts the inner wall, endothelial cells are removed, which is undesirable neointimal hyperplasia occurs. In an embodiment expanded by a balloon, an infusion tube combined with a guide tube expands the infusion needle outwardly and penetrates it into the inner wall of the target vasculature when the balloon expands In an embodiment expanded by a balloon, a sheath can be used to enclose the expandable distal portion to facilitate delivery and reduce needle sticks during handling, insertion, and removal of the catheter of the catheter. By attaching the guide tube or the infusion tube outside the balloon, the thin infusion needle is supported radially and laterally as it advances through the inner wall of the target vasculature to expand reliably and uniformly Another feature of the embodiments of the present application is to use a special connector having a small-diameter lumen for the infusion port for cauterizing fluid injection Also, in the present application, a syringe that mates with the special connector of the infusion port is envisioned. Such a syringe can contain an appropriate amount of a liquid

[0060] that is injected into the inner wall of the target vasculature containing the cauterizing fluid, or physiological saline used to flush the infusion tube before inserting the PTAC into the vasculature to be treated Another feature of the PTAC disclosed in the present application is to implement uniform circumferential delivery of the cauterizing fluid from the tip of each infusion needle by matching the fluid flow through the plurality of needles Another further feature of the PTAC disclosed in the present application is that the operator can fix the longitudinal movement of the catheter after the distal portion reaches the desired site within the renal artery This includes the present specification

[0061]

[0062]

[0062] There are several ways that can be implemented using many of the specific features of the PTAC as described in the detailed description. These methods include the following: 1. Close the Tuohy-Borst valve at the proximal end of the renal guide catheter to prevent the vertical movement of the PTAC. 2. Secure the proximal portion of the PTAC firmly to the patient's skin or the proximal end of the guide catheter using an adhesive pad or Velcro. 3. Use a mechanism inside the proximal portion or the handle of the PTAC to fix the vertical movement of the PTAC relative to the guide catheter. The mechanism includes the following: a. Slide the clip smoothly distally on the outer surface of the PTAC until it is locked on the outside of the proximal end of the guide catheter. When locked on the guide catheter, the clip becomes a friction lock against the vertical axis of the PTAC. b. Slide the locking tube smoothly distally into the proximal portion of the guide catheter where the proximal end of the locking tube is coupled to a mechanism inside the proximal portion / handle of the PTAC that actuates the guide tube and / or the injection tube. Moving the locking tube vertically or rotating it causes the distal portion of the locking tube to engage with the proximal portion of the guide catheter, preventing the vertical movement of the PTAC. For example, increasing the diameter of the locking tube creates a friction lock against either the inner surface of the Tuohy-Borst valve at the proximal end of the guide catheter or the locking tube itself.

[0063] Thus, one feature of the PTAC disclosed herein is an expandable supported needle guide through which the injection needle advances internally for injecting the ablation fluid into the outer layer or deep within the renal artery. ​​​​​​​​​​​​Comprising elements, and having a transcutaneously delivered catheter, such a design Thus, damage to the intimal layer and the medial layer of the renal artery is reduced or prevented.

[0064] In another aspect of the present application, the PTAC has a manually expandable guide tube / needle guiding element that advances outward from the body of the PTAC, and the PTAC has a support structure that radially supports the guide tube / needle guiding element toward the inner wall of the target blood vessel.

[0065] In another aspect of the present disclosure, the PTAC has a design with a manually expandable guide tube / needle guiding element that advances outward from a hollow shaft having a distal opening within the distal portion of the PTAC body , and the hollow shaft and the opening laterally support the guide tube / needle guiding element to reliably expand it uniformly and symmetrically in a circumferential / lateral direction. For example, when using three guide tube / needle guiding elements, when the guide tube / needle guiding elements expand outward, due to the lateral support, an angle of approximately 120° is reliably maintained between adjacent guide tube / needle guiding elements. .

[0066] In another aspect of the embodiments of the PTAC disclosed in the present application, the PTAC has an intraluminal central placement mechanism (ICM) that is attached to the guide tube / needle guiding element and further radially supports or backs up to prevent the guide tube / needle guiding element from being pushed away from the inner wall of the target blood vessel when an injection tube having a distal injection needle advances through the guide tube / needle guiding element into the perivascular space.

[0067] In another aspect of the PTAC of the present disclosure, the PTAC is attached to the guide tube / needle ​​​​is provided with an intraluminal central placement mechanism (ICM) that is laterally further supported to facilitate uniform expansion of the guide tube. has.

[0068] In yet another aspect of the PTAC of the present application, the PTAC has an intraluminal central placement mechanism (ICM) that reduces the potential for trauma to the inner wall of the target vasculature by the guide tube and guides the penetration of the injection needle for tissue ablation. has. has.

[0069] In yet another aspect of the present disclosure, a two - stage injection method for renal denervation is provided. First, before inserting into the patient's body, the catheter is filled with physiological saline, and after deploying the injection needle, the first injection of the ablation fluid (e.g., ethanol) is performed. After this injection, all of the ablation fluid is flushed out of the dead space of the catheter using non - toxic physiological saline or a similar liquid in the kidney. Then the PTAC is closed, and in the other renal artery, the same injection procedure is repeated. Then the PTAC is closed, and in the other renal artery, the same injection procedure is repeated. Next, the PTAC is closed, and in the other renal artery, the same injection procedure is repeated.

[0070] In yet another aspect of the present application, a one - stage injection method for denervation of each renal artery is provided. First, before inserting into the patient's body, the catheter is filled with the ablation fluid, and after deploying the injection needle, the ablation fluid (e.g., ethanol) is injected only once. Then the PTAC is closed and in the other renal artery, the same injection procedure is repeated. Next, the PTAC is closed, and in the other renal artery, the same injection procedure is repeated.

[0071] In yet another aspect of the present disclosure, the PTAC has at least three guide tube / needle guiding elements, each having a radiopaque marker. These guide tube / needle guiding elements are manually expandable outward from a set of hollow shafts, and the set of hollow shafts further supports and backs up each guide tube / needle guiding element to be stable against the inner wall of the target vasculature. has. Fix it. Actuate the mechanism within the proximal portion of the PTAC to complete the expansion of the guide tube / needle guiding element.

[0072] In yet another aspect of the present invention, an injection needle is provided on a curved and expandable injection tube, and the injection needle can advance coaxially through the guide tube. The radius of curvature of the distal portion of the injection tube is similar to the radius of curvature of the guide tube.

[0073] In yet another aspect of the embodiments of the present application, the guide tube and the injection tube are combined to form one injection tube having a thickened proximal portion, and this thickened proximal portion functions as a penetration control mechanism and can be manufactured to set a specific injection depth.

[0074] In yet another aspect of the PTAC of the present disclosure, an expandable balloon that radially expands and supports the guide tube / needle guiding element and / or the injection tube having a distal injection needle is used.

[0075] In yet another aspect of the PTAC of the present application, the flow resistances of a plurality of injection needles are made substantially the same.

[0076] In yet another aspect of the PTAC of the present disclosure, the PTAC includes one or more radiopaque markers that assist in the positioning, opening, closing locking, and use of the PTAC. The radiopaque markers include the following: · A radiopaque ring that marks the distal end of the sheath; · A radiopaque marker made of a metal strip or plastic having a radiopaque filler such as barium or tungsten, disposed at or near the end of the guide tube; · A radiopaque marker on the distal portion of the injection needle; ​​​​​ · Radiopaque wires within the lumen of the infusion tube and / or infusion needle; The distal fixation guidewire of the PTAC (e.g., platinum wire) is radiopaque. -); Radiopaque marker on the Intraluminal Central Mechanism (ICM).

[0077] Throughout this specification, the term "infusion tube having a distal injection needle" refers to a tube that penetrates into tissue. A tube having a pointed distal end for use in injecting fluid into tissue. Such structures are also called hypodermic needles, infusion needles, or simply needles. Additionally, the terms "element" and "structure" are used interchangeably within this application. The term "Luer fitting" is used throughout this application to mean a fine-tipped Luer fitting without a threaded cap. Or a Luer lock fitting with a screw cap.

[0078] These and other features and advantages of the present invention will become apparent to those skilled in the art in light of the following detailed description, drawings and claims, including those of ordinary skill in the art. This should become apparent upon reading the detailed description of the invention. [Brief description of the drawings]

[0079]

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DETAILED DESCRIPTION OF THE INVENTION

[0080] FIG. 1 is a longitudinal sectional view of the extended distal portion of the invention described in Fischell's U.S. Patent Application No. 13 / 643,070, filed on October 23, 2012. This intravascular nerve ablation system (INAS) 50 has, at its distal end, a fixed guide wire 20 with a tip 28. FIG. 1 shows, in a fully deployed state, a self-expanding guide tube 15, a coaxial injection tube 16, a sharp-tipped distal injection needle 19, and an INAS 5 0 having a needle distal opening 17, which is an injection outlet disposed outside the distal end 29 of the guide tube. In this embodiment of the INAS 50, four guide tubes 15 pass through It should be understood that there are four injection tubes 16 that protrude. This guide tube 15 is a needle guiding element that supports a thin and flexible injection tube 16 having a distal injection needle 19 as it penetrates into the inner wall of the target blood vessel inside.

[0081] In this configuration, the sheath 22 is retracted, and the guide tube 15 having a radiopaque marker band 27 can expand outward. If elements 15 and 16 are not made of a radiopaque metal, in order to well visualize the placement of the INAS 50 using standard fluoroscopy, the distal portions of the injection tube 16 and the guide tube 15 are marked with a radiopaque material such as gold or tantalum, or the injection tube 16 or the pointed distal injection needle 19 at the tip is formed of a radiopaque material, or a radiopaque material is disposed inside the injection tube 16 or the pointed distal injection needle 19 at the tip, is assumed. FIG. 1 shows a radiopaque wire 18 disposed inside the injection tube 16 so that the operator can clearly identify the position of the injection tube 16 having the distal injection needle 19 by fluoroscopy. Knowing the position of the injection needle 19 after advancing through the inner wall of the blood vessel is particularly important for the operator. The material for the radiopaque wire 18 can be selected from well-known radiopaque metals such as platinum, tungsten, or gold, or an alloy of this kind of metal or the like. If not made of a radiopaque metal, in order to well visualize the placement of the INAS 50 using standard fluoroscopy, the distal portions of the injection tube 16 and the guide tube 15 are marked with a radiopaque material such as gold or tantalum, or the injection tube 16 or the pointed distal injection needle 19 at the tip is formed of a radiopaque material, or a radiopaque material is disposed inside the injection tube 16 or the pointed distal injection needle 19 at the tip, is assumed. FIG. 1 shows a radiopaque wire 18 disposed inside the injection tube 16 so that the operator can clearly identify the position of the injection tube 16 having the distal injection needle 19 by fluoroscopy. Knowing the position of the injection needle 19 after advancing through the inner wall of the blood vessel is particularly important for the operator. The material for the radiopaque wire 18 can be selected from well-known radiopaque metals such as platinum, tungsten, or gold, or an alloy of this kind of metal or the like. It is assumed that the distal injection needle 19 is marked with a radiopaque material, or the injection tube 16 or the pointed distal injection needle 19 at the tip is formed of a radiopaque material, or a radiopaque material is disposed inside the injection tube 16 or the pointed distal injection needle 19 at the tip. FIG. 1 shows a radiopaque wire 18 disposed inside the injection tube 16 so that the operator can clearly identify the position of the injection tube 16 having the distal injection needle 19 by fluoroscopy. Knowing the position of the injection needle 19 after advancing through the inner wall of the blood vessel is particularly important for the operator. The material for the radiopaque wire 18 can be selected from well-known radiopaque metals such as platinum, tungsten, or gold, or an alloy of this kind of metal or the like. or the like. FIG. 1 shows a radiopaque wire 18 disposed inside the injection tube 16 so that the operator can clearly identify the position of the injection tube 16 having the distal injection needle 19 by fluoroscopy. Knowing the position of the injection needle 19 after advancing through the inner wall of the blood vessel is particularly important for the operator. The material for the radiopaque wire 18 can be selected from well-known radiopaque metals such as platinum, tungsten, or gold, or an alloy of this kind of metal or the like. FIG. 1 shows a radiopaque wire 18 disposed inside the injection tube 16 so that the operator can clearly identify the position of the injection tube 16 having the distal injection needle 19 by fluoroscopy. Knowing the position of the injection needle 19 after advancing through the inner wall of the blood vessel is particularly important for the operator. The material for the radiopaque wire 18 can be selected from well-known radiopaque metals such as platinum, tungsten, or gold, or an alloy of this kind of metal or the like. It is particularly important for the operator to know the position of the injection needle 19 after advancing through the inner wall of the blood vessel. The material for the radiopaque wire 18 can be selected from well-known radiopaque metals such as platinum, tungsten, or gold, or an alloy of this kind of metal or the like. or the like.

[0082] The diameter L1 indicates the shape memory of the fully expanded guide tube 15. For use in the renal artery, L1 is usually 3 mm to 10 mm, but since the diameter of the renal artery rarely exceeds 7 mm, 8 mm is optimal if only one size is used. As shown in FIG. 1 For use in the renal artery, L1 is usually 3 mm to 10 mm, but since the diameter of the renal artery rarely exceeds 7 mm, 8 mm is optimal if only one size is used. As shown in FIG. 1 For use in the renal artery, L1 is usually 3 mm to 10 mm, but since the diameter of the renal artery rarely exceeds 7 mm, 8 mm is optimal if only one size is used. As shown in FIG. 1 As such, the distal end 29 of the guide tube 15 in the fully expanded state is parallel to the longitudinal axis of the INAS 50 and has a plane. The distal portion of the INAS 50 has a tapered portion 26, a radio-opaque marker band 24, and a proximal portion 23. This tapered portion including elements 23, 24, and 26 is called the occlusion portion 30. The occlusion portion 30 is fixedly attached to the outer layer 25 of the core wire 11 and the guide tube 20. Another important feature of this design is the relative position of the distal end of the sheath 22 and the occlusion portion 30 together with the radio-opaque marker band 24 on the occlusion portion 3 0. A radio-opaque marker 13 that displays information is located at the distal end of the sheath 22 When the radio-opaque marker 13 located at the distal end of the sheath 22 is very close to the radio-opaque marker band 24 of the occlusion portion 30, the operator can know that the guide tube 15 including the injection tube 16 is fully contracted. When the radio-opaque marker 13 of the sheath 22 is sufficiently separated, the operator can know that at least the guide tubes 15 are arranged outside each other and their distal ends 29 are in contact with the inner surface of the blood vessel. When the injection tube 16 having the distal injection needle 19 advances coaxially through the guide tube 1 5 and penetrates the inner wall of the target blood vessel, the normally preformed radius of curvature of the injection tube 16 should match the radius of curvature of the guide tube 1 5 so as to maintain its position relative to the inner wall of the target blood vessel. As disclosed in Fischell's US patent application The limit of this design, as described above, is that it has an unsupported self-expanding needle-guiding element structure such as the guide tube 15 that cannot be automatically centered within the target blood vessel When the injection tube 16 having the distal injection needle 19 advances coaxially through the guide tube 1 5 and penetrates the inner wall of the target blood vessel, the normally preformed radius of curvature of the injection tube 16 should match the radius of curvature of the guide tube 1 5 so as to maintain its position relative to the inner wall of the target blood vessel. As disclosed in Fischell's US patent application It should also be that the radius of curvature of the injection tube 16 should match the radius of curvature of the guide tube 15. As disclosed in Fischell's US patent application The limit of this design, as described above, is that it has an unsupported self-expanding needle-guiding element structure such as the guide tube 15 that cannot be automatically centered within the target blood vessel As described above, the limitation of this design is that an unsupported self-expanding needle-guiding element structure such as the guide tube 15 that cannot be automatically centered within the target blood vessel It is reliability and stability. Also, the guide tube 15 without any radial support may move away from the inner wall of the target vessel while the injection tube 16 advances. During the advancement of the injection tube 16, it may move away from the inner wall of the target vessel.

[0083] Figure 2 is a schematic view of the distal portion of the PTAC 100 in its expanded position, showing the outer tube extension 104 having a distal opening 131 through which the outer tube 102 and the guide tube 115 having the radiopaque marker 122 and advancing outside the body of the PTAC 100 pass. The fixed guide wire 110 having the tapered portion 106 and the distal tip 109 is also shown. The injection tube 116 having the distal injection needle 119 and the needle distal opening 117 is shown in its fully deployed position. The opening 131 supports the side of the guide tube 115 when the guide tube 115 advances outward prior to the advancement of the injection tube 116 having the distal injection needle 119. The PTAC 100 of Figure 2 has three guide tubes, and the third guide tube is hidden behind the catheter and not visible in this schematic view. The PTAC 100 of Figure 2 has three guide tubes 115, and in other embodiments, the number of guide tubes can be as few as one or as many as eight, but the optimal number of guide tubes is three or four. As the diameter of the target vessel becomes larger, four to eight or more guide tubes 115 and injection tubes 116 will be used. During the advancement of the injection tube 16, it may move away from the inner wall of the target vessel. During the advancement of the injection tube 16, it may move away from the inner wall of the target vessel. During the advancement of the injection tube 16, it may move away from the inner wall of the target vessel. During the advancement of the injection tube 16, it may move away from the inner wall of the target vessel. During the advancement of the injection tube 16, it may move away from the inner wall of the target vessel. During the advancement of the injection tube 16, it may move away from the inner wall of the target vessel. During the advancement of the injection tube 16, it may move away from the inner wall of the target vessel. During the advancement of the injection tube 16, it may move away from the inner wall of the target vessel. During the advancement of the injection tube 16, it may move away from the inner wall of the target vessel. During the advancement of the injection tube 16, it may move away from the inner wall of the target vessel. During the advancement of the injection tube 16, it may move away from the inner wall of the target vessel. During the advancement of the injection tube 16, it may move away from the inner wall of the target vessel. During the advancement of the injection tube 16, it may move away from the inner wall of the target vessel.

[0084] Regarding the distal opening (or window) 131 in the outer tube extension 104, which is the exit of the guide tube 115, different shapes are also envisioned. These possible shapes include curved ( During the advancement of the injection tube 16, it may move away from the inner wall of the target vessel. For example, round) proximal and distal ends, axially linear sides, and an oval or round shape is included. A movable lid covering the opening 131, or a slit provided to smooth the outer surface of the PTAC is also envisioned.

[0085] It is an important feature of the present invention that the guide tube 115 is a needle guiding element for the very thin injection needle 119. Specifically, in the prior art of Jacobson et al. which describes a curved needle that advances outward from the central catheter and penetrates the inner wall of the target vessel end, the needle advances (not covered) on its own from the distal end or side of the catheter. If there is no support and backup during advancement, a needle that is thin enough to have no risk of bleeding after penetrating and retracting into the arterial wall is generally too fragile to reliably penetrate into the vessel wall as desired. Therefore, an important aspect of the PTAC 100 of the present application is envisioned to include a needle guiding element such as the guide tube 115 that enables the very thin needle 119 to reliably advance to the desired depth within the wall of the target vessel.

[0086] Figure 3 is a longitudinal sectional view of the distal portion of the PTAC 100 shown in Figure 2. At the proximal end of Figure 3, there is shown the central portion of the PTAC 100, which occupies most of the total length of the PTAC 100, three concentric tubes, the outer tube 102, the intermediate tube 103, and the inner tube 1 05. The outer tube 102 is connected to the outer tube extension 104, and the outer tube extension 104 is connected to the tapered portion 106. The fixed guide wire 110 having the core wire 111 and the outer layer 113 extends from the distal end of the tapered portion 106 ​​​​​​​​​​​​extends distally. Only a part of the entire length of the guide wire 110 is shown in FIG. 3, it should be noted that the entire length of the guide wire 110 is shown in FIG. 2. The sec tions S4 and S5 are shown in FIGS. 4 and 5, respectively.

[0087] FIG. 3 shows a guide tube 115 having a radiopaque marker 122 in a state where it has advanced completely through an opening 131 in the outer tube extension portion 104. The inner surface of the outer tube extension portion 104 that forms a part of the hollow shaft 120 should be formed of a rigid material such as metal or a high durometer hardness plastic hook so as to be relatively rigid when the guide tube 115 advances and retracts.

[0088] In a preferred embodiment of the PTAC 100 of the present application, instead of the outer tube 102 and the outer tube extension portion 104, four different tube-like structures are used. Specifically , the proximal portion of the PTAC is a metal hypo tube 82 shown in FIG. 11. This metal hypo tube 82 is connected at its distal end to a rigid plastic tube 92 (see FIG. 18) having a length of approximately 20 cm, and the rigid plastic tube 92 is connected to a more flexible and higher plastic tube having a length of approximately 10 cm, which is the tube 102 shown in FIGS. 2 and 7. Usually, the plastic tubes 92 and 102 have the same inner diameter and outer diameter. Usually, the outer tube extension portion 104, which is the distal end portion of the catheter body , has an inner diameter slightly larger than the inner diameter of the flexible outer tube 102. The connecting tube 125 that connects the inner tube 105 to the injection tube 116 is coaxial inside the plastic tubes 92 and 102, at the distal end of the catheter body of the PTAC 100 proximal by at least several centimeters from the outer tube extension 104 which is the distal end of the catheter body is located.

[0089] In a preferred embodiment, the intermediate tube 103 that is continuous with the distal metal hypo tube and the inner tube 105 is also connected to the proximal part made of the metal hypo tube The structure of these tubes is shown in FIG. 18. is connected.

[0090] An important aspect of the PTAC 100 disclosed herein is to minimize the internal volume of the injection path, i.e., the "dead space" By minimizing the dead space, the required amount of liquid to be injected into the perivascular space before injecting the ablation liquid is reduced. In one version of the usage method, before inserting the PTAC 100 into the patient's body, first flush the dead space with saline outside the body and then fill the dead space with saline. Ideally, the dead space should be less than 0.3 mL and preferably approximately 0.1 mL if possible. If it is less than 0.5 mL, it is useful for minimizing the amount of flushing liquid to be injected into the perivascular space prior to injecting the ablation liquid and then fill the dead space with saline. Ideally, the dead space should be less than 0.3 mL and preferably approximately 0.1 mL if possible. If it is less than 0.5 mL, it is useful for minimizing the amount of flushing liquid to be injected into the perivascular space prior to injecting the ablation liquid is useful for minimizing the amount of flushing liquid to be injected into the perivascular space prior to injecting the ablation liquid.

[0091] The central support portion 121 shown in FIG. 3 supports the guide tube 115 both when advancing distally and after being fully deployed This central support portion 121 mainly supports the advancement of the guide tube 115 in the radial direction so as to prevent the guide tube 115 from being pushed away from the inner wall of the target vessel when the injection tube 1 16 advances through the guide tube 115 to a desired position 2 mm to 4 mm from the inner wall of the target vessel prevents the guide tube 115 from being pushed away from the inner wall of the target vessel. In exceptional cases prevents the guide tube 115 from being pushed away from the inner wall of the target vessel. In exceptional cases Then, the injection needle 119 at the distal end of the injection tube 116 advances to a depth of 8 mm from the inner wall of the target vessel. The lateral support of the guide tube 115 is mainly provided by the side surface of the opening 131, and the opening 131, together with the central support portion 121, serves as a requirement for radial and circumferential / lateral support when the guide tube 115 advances and expands outward, and also serves as a backup while the injection needle 119 is being delivered through the inner wall of the target vessel. The central support portion 121 can include a deflecting surface such as a curved inclination or a linear inclination. In the case of an embodiment where the deflecting surface is curved, the radius of curvature thereof may coincide with the radius of curvature of the distal surface of the guide tube 115. In the case of an embodiment with a curved inclination, the central support portion 121 and the hollow shaft 120 also provide lateral support to facilitate the radial expansion of the guide tube 115 only. The central support portion 121 supports the guide tube 115 in the radial and lateral directions. In other embodiments described herein, it can support only in the radial direction or only in the lateral direction. Supporting the guide tube 115 in the radial direction is defined herein as supporting the guide tube 115 in a direction perpendicular to the longitudinal axis of the PTAC 100. Supporting the guide tube 115 in the lateral direction is defined herein as supporting the guide tube 115 in the circumferential direction that is perpendicular to the radial direction.

[0092] It is also an important feature that the radius of curvature of the central axis of the distal portion of the injection tube 116 is the same as or nearly the same as the radius of curvature of the central axis of the guide tube 115 measured in the unconstrained state and the radius of curvature of the central axis of the distal portion of the hollow shaft 120 formed within the central support portion 121.

[0092]

[0092] The length of the tube 115 should be at least the same as the length of the curved portion distal to the injection tube 116 having the distal needle 119. With such a design, the curved portion of each injection tube 116 is constrained within the lumen of the guide tube 115, and the injection tube 116 will neither twist nor displace. A more detailed view of the distal portion of the central support portion 121 is shown in FIG. 17. As can be seen from FIG. 3, the inner tube 105 having the liquid injection lumen 133 is connected to the three injection tubes 116 via the connecting tube 125. Therefore, the lumen of the injection tube 116 is in fluid communication with the liquid injection lumen 133. The inner tube 105 and the connecting tube 125 can move smoothly along the longitudinal axis of the PTAC 100 inside the intermediate tube 103 having the same diameter throughout its entire length, including the coaxially outer portion of the connecting tube 125. As can be seen from FIG. 3, it is clear that the connecting tube 125 is located in the lumen of the inner tube 105, proximal to the distal end of the inner tube 105. Both the inner tube 105 and the connecting tube 125 are coaxially located proximal to the outer tube extension portion 104, which is the distal end portion outside the main body of the PTAC 100, within the outer tube 102 of the PTAC 100. This is significantly different from the embodiment shown in FIG. 3 of Jacobson's U.S. Patent No. 6,302,870, where the connecting tube for connecting the tube to the needle is attached to the distal end of the tube (inside it and not proximal to the distal end). Also, Jacobson's connecting tube is coaxially inside the distal end portion outside the main body of the catheter.

[0093] A more detailed view of the distal portion of the central support portion 121 is shown in FIG. 17.

[0094] As can be seen from FIG. 3, the inner tube 105 having the liquid injection lumen 133 is connected to the three injection tubes 116 via the connecting tube 125. Therefore, the lumen of the injection tube 116 is in fluid communication with the liquid injection lumen 133. As can be seen from FIG. 3, the inner tube 105 having the liquid injection lumen 133 is connected to the three injection tubes 116 via the connecting tube 125. Therefore, the lumen of the injection tube 116 is in fluid communication with the liquid injection lumen 133. The inner tube 105 and the connecting tube 125 can move smoothly along the longitudinal axis of the PTAC 100 inside the intermediate tube 103 having the same diameter throughout its entire length, including the coaxially outer portion of the connecting tube 125. As can be seen from FIG. 3, the inner tube 105 having the liquid injection lumen 133 is connected to the three injection tubes 116 via the connecting tube 125. Therefore, the lumen of the injection tube 116 is in fluid communication with the liquid injection lumen 133. The inner tube 105 and the connecting tube 125 can move smoothly along the longitudinal axis of the PTAC 100 inside the intermediate tube 103 having the same diameter throughout its entire length, including the coaxially outer portion of the connecting tube 125. As can be seen from FIG. 3, the inner tube 105 having the liquid injection lumen 133 is connected to the three injection tubes 116 via the connecting tube 125. Therefore, the lumen of the injection tube 116 is in fluid communication with the liquid injection lumen 133. The inner tube 105 and the connecting tube 125 can move smoothly along the longitudinal axis of the PTAC 100 inside the intermediate tube 103 having the same diameter throughout its entire length, including the coaxially outer portion of the connecting tube 125. As can be seen from FIG. 3, the inner tube 105 having the liquid injection lumen 133 is connected to the three injection tubes 116 via the connecting tube 125. Therefore, the lumen of the injection tube 116 is in fluid communication with the liquid injection lumen 133. The inner tube 105 and the connecting tube 125 can move smoothly along the longitudinal axis of the PTAC 100 inside the intermediate tube 103 having the same diameter throughout its entire length, including the coaxially outer portion of the connecting tube 125. As can be seen from FIG. 3, the inner tube 105 having the liquid injection lumen 133 is connected to the three injection tubes 116 via the connecting tube 125. Therefore, the lumen of the injection tube 116 is in fluid communication with the liquid injection lumen 133. The inner tube 105 and the connecting tube 125 can move smoothly along the longitudinal axis of the PTAC 100 inside the intermediate tube 103 having the same diameter throughout its entire length, including the coaxially outer portion of the connecting tube 125.

[0095] As can be seen from FIG. 3, it is clear that the connecting tube 125 is located in the lumen of the inner tube 105, proximal to the distal end of the inner tube 105. As can be seen from FIG. 3, it is clear that the connecting tube 125 is located in the lumen of the inner tube 105, proximal to the distal end of the inner tube 105. Both the inner tube 105 and the connecting tube 125 are coaxially located proximal to the outer tube extension portion 104, which is the distal end portion outside the main body of the PTAC 100, within the outer tube 102 of the PTAC 100. As can be seen from FIG. 3, it is clear that the connecting tube 125 is located in the lumen of the inner tube 105, proximal to the distal end of the inner tube 105. Both the inner tube 105 and the connecting tube 125 are coaxially located proximal to the outer tube extension portion 104, which is the distal end portion outside the main body of the PTAC 100, within the outer tube 102 of the PTAC 100. As can be seen from FIG. 3, it is clear that the connecting tube 125 is located in the lumen of the inner tube 105, proximal to the distal end of the inner tube 105. Both the inner tube 105 and the connecting tube 125 are coaxially located proximal to the outer tube extension portion 104, which is the distal end portion outside the main body of the PTAC 100, within the outer tube 102 of the PTAC 100. As can be seen from FIG. 3, it is clear that the connecting tube 125 is located in the lumen of the inner tube 105, proximal to the distal end of the inner tube 105. Both the inner tube 105 and the connecting tube 125 are coaxially located proximal to the outer tube extension portion 104, which is the distal end portion outside the main body of the PTAC 100, within the outer tube 102 of the PTAC 100. As can be seen from FIG. 3, it is clear that the connecting tube 125 is located in the lumen of the inner tube 105, proximal to the distal end of the inner tube 105. Both the inner tube 105 and the connecting tube 125 are coaxially located proximal to the outer tube extension portion 104, which is the distal end portion outside the main body of the PTAC 100, within the outer tube 102 of the PTAC 100. This is significantly different from the embodiment shown in FIG. 3 of Jacobson's U.S. Patent No. 6,302,870, where the connecting tube for connecting the tube to the needle is attached to the distal end of the tube (inside it and not proximal to the distal end). Also, Jacobson's connecting tube is coaxially inside the distal end portion outside the main body of the catheter. It is located proximal to the distal end of the catheter, not inside the tube. The distal end is defined as the distal portion of the catheter from which the needle exits and curves outward and enters within the inner wall of the blood vessel.

[0096] The flow rate through each needle distal opening 117 of the needle 119 of the PTAC 100 in FIGS. 2 to 4 being substantially the same can also be an important feature of the PTAC 100. That the flow rate is substantially the same can be very easily confirmed by pre - testing each injection tube 116 having the injection needle 119 and measuring the flow rate and flow resistance under a predetermined pressure. Based on the results of that test, the injection tubes 116 can be sorted, and the injection tubes sorted for each PTAC 100 are combined so that their flow resistances are substantially the same.

[0097] FIG. 4 is an enlarged view of region S4 of the longitudinal cross - sectional view of the PTAC 100 shown in FIG. 3. FIG. 4 shows details of the guide tube 115 having an inner layer 123, an outer layer 127, a distal end 129, and a radiopaque marker 122. Coaxially within the lumen of the guide tube 115 are an injection tube 116 having a distal injection needle 119, a distal opening 117, and a radiopaque marker wire 118. The radiopaque marker wire 118 serves two purposes. First, when the injection tube advances to a position for delivering the ablation fluid into the perivascular space and deep within the adventitia of the target blood vessel, the position of the injection tube is fluoroscopically visualized. Second, the radiopaque marker wire 118 reduces the internal volume of the injection tube 11 6 so that when the PTAC 100 retracts from the renal artery, harmless physiological Leave only saline, and reduce the amount of saline necessary to flush all ablation fluid into the perivascular space outside the PTAC 100. The radiopacity of the injection tube 116 having the distal injection needle 119 is very important so that the operator can confirm under fluoroscopy that the needle 119 is properly positioned within the inner wall of the target vessel. In other embodiments of the present disclosure, a coating, plating, or marking on the outside and / or inside of the injection tube 116 and the injection needle 119 can be used, or the injection tube 116 having the distal injection needle 119 can be made of a two-layer coating material. For example, covering and shaping a nitinol tube with a platinum inner tube is ideal because it provides high visibility and obviates the need for the radiopaque marker wire 118 shown in FIGS. 3 and 4. The guide tube 115 advances and retracts through the hollow shaft 120 having the distal opening 131. The three guide tubes 115 are in contact with each other by the guide tube connector 132 near the proximal end. FIG. 4 also clearly shows how the guide tube 115 is directed and supported outwardly by the curved inclination 144 of the central support portion 121 and further by the side surface of the opening 131 of the hollow shaft 120 when advancing towards the central support portion 121. The central support portion 121 also has proximal finger portions 142 that further support the guide tube 115 laterally. The outer tube extension 104 is connected at its distal end to the tapered portion 106, and the tapered portion 106 is coaxial with the guide wire 110 together with the core wire 111 and the outer layer 113.

[0098]

[0099]

[0100] Similarly, shown in FIG. 4 is the penetration depth L2, which is from the distal end 129 of the guide tube 11 5 to the center of the distal opening 117 located at the distal end of the injection needle 119 distance. The mechanism at the proximal end of the PTAC 100 (as shown in FIG. 11) controls the movement of the distal components such as the injection tube 116 and the guide tube 115, and further limits and / or adjusts the penetration depth L2 of the injection needle 119.

[0101] The central support portion 121 and the distal opening 131 can be separate components of the PTAC 100, as shown in FIG. 4, or, as shown in FIG. 17, they can be formed as a single molded part or a machined part. The distal tip 14 5 of the central support portion 121 connects and fixes the central support portion 121 to the tapered portion 106. Also, the central support portion 121 , the distal opening 131, and the tapered portion 106 can be a single molded or machined part .

[0102] In a preferred embodiment of the PTAC 100, the guide tube 115 has a pre-formed curved shape, but when the central support portion 121 bends the straight guide tube outward towards the inner wall of the target vessel, a guide tube with a flexible natural straightness is also envisioned .

[0103] In this specification, the term "central support portion" is used, but the most important component of the central support portion 121 is the inclination 144 that supports the deployed guide tube 115 radially and to some extent laterally . Specifically, the curved inclination 144 of the central support portion 121 supports the outward movement of the guide tube 115 when it exits through the distal opening 131 and​​​ induce and radially support when the guide tube 115 and the injection tube 116 engage with the inner wall of the target vessel The finger-like portion 142 of the central support portion 121 further supports laterally .

[0104] The inclination 144 or the shape of the central support portion 121 includes a smooth and curved surface or an inclined surface that guides the guide tube 115 outward when the guide tube 115 advances distally through the distal opening 131, and also includes a proximal extension or finger-like portion The central support portion 121 shown in FIG. 4 is a plastic part, but a part made of a radiopaque metal such as stainless steel, or a plastic part containing a radiopaque filler such as tungsten can also be preferably used to indicate the precise position where the guide tube 115 exits from the PTAC 100. A radiopaque marker is also assumed to be disposed or attached to the distal opening portion 131 or a part of the central support portion 121 or the outer tube extension portion 104 so as to similarly indicate the point where the guide tube 115 and thus the injection needle 119 also engage with the inner wall of the target vessel

[0105] The central support portion 121 shown in FIG. 4 is a plastic part, but a part made of a radiopaque metal such as stainless steel, or a plastic part containing a radiopaque filler such as tungsten can also be preferably used to indicate the precise position where the guide tube 115 exits from the PTAC 100. A radiopaque marker is also assumed to be disposed or attached to the distal opening portion 131 or a part of the central support portion 121 or the outer tube extension portion 104 so as to similarly indicate the point where the guide tube 115 and thus the injection needle 119 also engage with the inner wall of the target vessel

[0106] Generally, many of the parts of the PTAC 100 are made of plastic materials such as polyamide, polyurethane, nylon, or Techothane (registered trademark, a type of thermoplastic polyurethane). These plastic parts include the outer tube 102, the intermediate tube 103, and the inner tube 105, the outer tube extension portion 104, the inner layer 123 and the outer layer 127 of the guide tube 115, the tapered portion 106, the central support portion 121, the guide tube ​​​​​​​​​​​Examples include the tube connector 132 and the connecting tube 125. The connecting tube 125 can be a molded part or, alternatively, epoxy resin or other resin can be used to bond the injection tube 116 to the inner tube 105.

[0107] Any one or all of the inner tube 105, the intermediate tube 103, or the outer tube 102 can also be assumed to be a metal hypodermic tube or a metal-reinforced plastic tube.

[0108] Normally, the injection tube 116 is made of a shape memory metal such as a spring or nitinol. The radiopaque marker wire 118 and the guide tube radiopaque marker 12 2 can also be made of gold, platinum, or tantalum, or an alloy of these metals or similar metals. Normally, the core wire 111 is stainless steel and the outer layer 113 is a platinum-wound wire or a platinum-indium wire. The outer layer 113 can also be a polymer material. Any one or several parts outside the PTAC 100 can be coated with a lubricant for property improvement. The injection tube 116 and the injection needle 11 9 should have a diameter of less than 0.5 mm, preferably less than 0.3 mm, in order to avoid any blood loss or leakage when the needle penetrates the inner wall of the target blood vessel and when it retracts from the inner wall of the target blood vessel.

[0109] Figure 5 is an enlarged view of region S5 of the PTAC shown in Figure 3, showing the transition from the central part to the distal part of the PTAC 100 including the outer tube 102, the intermediate tube 103, and the inner tube 105 together with the injection lumen 133. The connection between the outer tube 102 and the outer tube extension 104 is also shown. ​​​​​​​is shown. In FIG. 5, the proximal end of the injection tube 116 is distal to the proximal end of the connecting tube 125, but for the manufacture of the PTAC 100, it is preferable that the proximal end of the injection tube 116

[0110] The guide tube connector 132 connects the three guide tubes 115 to the intermediate tube 103 that supplies a propulsive force for forward and backward movement to the three guide tubes 115. This movement of the intermediate tube 103 is brought about by the movement of the control mechanism at the proximal end of the PTAC 100. The connecting tube 125 is located inside the distal part of the inner tube 105 and is connected to any of the three injection tubes 116, so that the forward and backward movement of the inner tube 105 is synchronized with the forward and backward movement of the injection tubes 116. The flushing spaces between some of the tubes are also shown in FIG. 5. Specifically shown are the outer annular gap 137 between the intermediate tube 103 and the outer tube 102, and the inner annular gap 139 between the inner tube 105 and the intermediate tube 103. These gaps 137 and 139 must be flushed with physiological saline prior to the insertion of the PTAC 100 into the patient's body. respectively.

[0111] Looking at FIG. 5, it can also be seen how the proximal end of the injection tube 116 is in fluid communication with the injection lumen 133 of the inner tube 105. The radiopaque wire 118 located within the lumen of the injection tube 116 extends proximally from the proximal end of the injection tube 116 and is connected within the body of the connecting tube 1 25. Instead of connecting within the body of the connecting tube 125, the three radiopaque wires It is also envisioned to weld the impermeable wires to each other and / or attach them to the proximal end of the connecting tube 125. The longitudinal movement of the inner tube 105 within the intermediate tube 103 of uniform diameter also moves the connecting tube 125 and the injection tube 116 attached thereto longitudinally. P Such longitudinal movement by the control mechanism near the proximal end of the PTAC 100 advances and retracts the injection tube 116 through the lumen of the guide tube 115, expands it outwardly to penetrate the inner wall of the target blood vessel, facilitating the delivery of the ablation fluid.

[0112] FIG. 5 shows how the three injection tubes 116 extend from the distal ends of the inner tube 105 and the connecting tube 125 and then enter the lumen of the outer layer 127 of the proximal end of the guide tube 115 of the guide tube 115. The guide tube 115 and the guide tube connector 132 are coaxially connected within the distal portion of the intermediate tube 103. Accordingly the longitudinal movement of the intermediate tube 103 causes the longitudinal movement of the guide tube connector 132 and the guide tube 115, enabling the mechanism in the proximal portion of the PTAC 100 to advance and retract the guide tube 115 with respect to the outer tube 102 and the outer tube extension 104. It is also envisioned that the penetration depth limit could be a mechanism that restricts the advancement of the inner tube 105 relative to the guide tube connector 132. A ring or other structure located between the distal ends of the inner tube 105 or between the proximal end of the connecting tube 125 and the guide tube connector 132 restricts the advancement (distalward) of the inner tube 105, causing the needle 119 to penetrate the guide tube 1

[0113] It is also envisioned that the penetration depth limit could be a mechanism that restricts the advancement of the inner tube 105 relative to the guide tube connector 132. Between the distal ends of the inner tube 105 or between the connecting tube 125 and the proximal end of the guide tube connector 132, a ring or other structure restricts the advancement (distalward) of the inner tube 105, causing the needle 119 to penetrate the guide tube 1 Restrict penetration beyond the distal end 129 of 15. Such a structure is the inner tube 1 05, the connecting tube 125, the injection tube 116, the guide tube connector 132, the guide tube 115 at the proximal end, or may be attachable or not attachable to the internal structure of the PTAC 100 shown in FIG. 5 such as the intermediate tube 103. Such a structure may also have a length adjustment mechanism such as a thread that can be used to adjust the penetration depth beyond the distal end 129 of the guide tube 115 of the needle 119. It can be attached or not attached to the internal structure of the PTAC 100 shown in FIG. 5 such as the intermediate tube 103. Such a structure may also have a length adjustment mechanism such as a thread that can be used to adjust the penetration depth beyond the distal end 129 of the guide tube 115 of the needle 119. It can be attached or not attached to the internal structure of the PTAC 100 shown in FIG. 5 such as the intermediate tube 103. Such a structure may also have a length adjustment mechanism such as a thread that can be used to adjust the penetration depth beyond the distal end 129 of the guide tube 115 of the needle 119. It can be attached or not attached to the internal structure of the PTAC 100 shown in FIG. 5 such as the intermediate tube 103. Such a structure may also have a length adjustment mechanism such as a thread that can be used to adjust the penetration depth beyond the distal end 129 of the guide tube 115 of the needle 119.

[0114] FIG. 6 is a cross-sectional view taken along section 6-6 of the PTAC 100 shown in FIG. 5. FIG. 6 shows the coaxial elements of the body of the PTAC 100, including the outer tube 102, the intermediate tube 103, the inner tube 105, the outer annular gap 137 between the intermediate tube 103 and the outer tube 102, and the inner annular gap 139 between the inner tube 105 and the intermediate tube 103. FIG. 6 also shows how the connecting tube 125 bundles the three injection tubes 116 having the radiopaque wire 118 inside the inner tube 105. 6 shows the coaxial elements of the body of the PTAC 100, including the outer tube 102, the intermediate tube 103, the inner tube 105, the outer annular gap 137 between the intermediate tube 103 and the outer tube 102, and the inner annular gap 139 between the inner tube 105 and the intermediate tube 103. FIG. 6 also shows how the connecting tube 125 bundles the three injection tubes 116 having the radiopaque wire 118 inside the inner tube 105. 6 shows the coaxial elements of the body of the PTAC 100, including the outer tube 102, the intermediate tube 103, the inner tube 105, the outer annular gap 137 between the intermediate tube 103 and the outer tube 102, and the inner annular gap 139 between the inner tube 105 and the intermediate tube 103. FIG. 6 also shows how the connecting tube 125 bundles the three injection tubes 116 having the radiopaque wire 118 inside the inner tube 105. 6 shows the coaxial elements of the body of the PTAC 100, including the outer tube 102, the intermediate tube 103, the inner tube 105, the outer annular gap 137 between the intermediate tube 103 and the outer tube 102, and the inner annular gap 139 between the inner tube 105 and the intermediate tube 103. FIG. 6 also shows how the connecting tube 125 bundles the three injection tubes 116 having the radiopaque wire 118 inside the inner tube 105. 6 shows the coaxial elements of the body of the PTAC 100, including the outer tube 102, the intermediate tube 103, the inner tube 105, the outer annular gap 137 between the intermediate tube 103 and the outer tube 102, and the inner annular gap 139 between the inner tube 105 and the intermediate tube 103. FIG. 6 also shows how the connecting tube 125 bundles the three injection tubes 116 having the radiopaque wire 118 inside the inner tube 105. 6 shows the coaxial elements of the body of the PTAC 100, including the outer tube 102, the intermediate tube 103, the inner tube 105, the outer annular gap 137 between the intermediate tube 103 and the outer tube 102, and the inner annular gap 139 between the inner tube 105 and the intermediate tube 103. FIG. 6 also shows how the connecting tube 125 bundles the three injection tubes 116 having the radiopaque wire 118 inside the inner tube 105.

[0115] FIG. 7 is a cross-sectional view taken along section 7-7 of the PTAC 100 shown in FIG. 5. FIG. 7 shows the coaxial arrangement of the outer tube 102, which is distally connected to the outer tube extension 104 that restricts the outside of the intermediate tube 103. The guide tube connector 132 is connected to the three guide tubes 115 having an outer plastic layer 127 located inside the guide tube connector 132 itself, which is located inside the intermediate tube 103. 7 shows the coaxial arrangement of the outer tube 102, which is distally connected to the outer tube extension 104 that restricts the outside of the intermediate tube 103. The guide tube connector 132 is connected to the three guide tubes 115 having an outer plastic layer 127 located inside the guide tube connector 132 itself, which is located inside the intermediate tube 103. 7 shows the coaxial arrangement of the outer tube 102, which is distally connected to the outer tube extension 104 that restricts the outside of the intermediate tube 103. The guide tube connector 132 is connected to the three guide tubes 115 having an outer plastic layer 127 located inside the guide tube connector 132 itself, which is located inside the intermediate tube 103. 7 shows the coaxial arrangement of the outer tube 102, which is distally connected to the outer tube extension 104 that restricts the outside of the intermediate tube 103. The guide tube connector 132 is connected to the three guide tubes 115 having an outer plastic layer 127 located inside the guide tube connector 132 itself, which is located inside the intermediate tube 103. With such a structure, the longitudinal movement of the intermediate tube 103 is restricted by the connected guide Similar movements in the tube connector 132 and the guide tube 115 can be caused.

[0116] Figures 8-11 show how the PTAC 100 is used in perivascular renal denervation, , a set of schematic diagrams. Figure 8 shows a distal portion of the PTAC 100 in its pre-deployment state, having an outer tube 102, an outer tube extension 104, a tapered portion 106, and a distal end 109 with a guide wire 110 fixed to the distal side. Two of the three distal openings 131 are shown on the surface of the outer tube extension 104. In Figure 8, the distal portion of the PTAC 100 is pushed from the distal end of the renal guide catheter 140 into the position within the renal artery. The internal elastic lamina (IEL), media, external elastic lamina (EEL), renal artery, and the adventitia of the aorta are also shown.

[0117] Figure 9 shows a schematic of the distal portion of the PTAC 100 within the renal artery with the guide tube 115 fully expanded outward against the inner wall of the renal artery. Since the renal artery and aorta are shown in cross-section, the lower guide tube 115 is actually in contact with a portion of the inner wall of the renal artery but is not shown. This is because this cross-sectional view is a composite of the renal artery cut at 0° and 180°. The third guide tube 115 is not visible. This is because it is in too much contact with the inner surface of the renal artery and is hidden behind the PTAC 100. The radiopaque marker 122 on the guide tube 115 allows the operator to visualize and know that the fully expanded guide tube 115 is actually in contact with the inner wall of the renal artery. As the guide tube 115 exits the opening 131 within the outer tube extension 104, the outer It is very important to be supported laterally when deploying. The central support shown in FIG. 4 is supported radially by the portion 121. The guide tube being supported both radially and laterally is very important because the guide tube expands uniformly and the distal portion of the PTAC 100 can be located at the center of the target vessel, allowing the injection needle 119 to be deployed as shown in FIG. 10.

[0118] FIG. 10 shows a schematic of the distal portion of the PTAC 100 within the renal artery in a state where the injection tube 116 having the distal injection needle 119 is fully deployed to deliver the ablation fluid into the adventitia of the renal artery and / or the perivascular space deep within. Ideally, the needle distal opening 117, which is at or near the distal end of the injection needle 119, should be positioned outside the adventitia at the tip of the EEL, as shown for the upper needle 119 in FIG. 10. The third needle 119 and guide tube 115 are hidden behind the body of the PTAC 100 and are not visible in FIG. 10. The sympathetic nerves, which are the target of renal denervation, are located within the adventitia or a few millimeters outside the adventitia. Specifically, a position 2 mm to 4 mm deep from the IEL is a suitable position for the needle distal opening 117. If the sympathetic nerves are further deep, a distance of 4 mm to 8 mm is assumed.

[0119] FIG. 11 is a schematic view of an embodiment of the proximal portion 300 (i.e., the handle) of the PTAC 100 having a control mechanism for advancing and retracting the injection tube 116 having the needle guiding element / guide tube 115 and the distal needle 119 during the procedure of delivering the ablation fluid to the perivascular space. The handle 300 is actuated by first control and second control such as push buttons 332 and 342. ​​​​​​​​​​​​​​It also has a moving locking mechanism. Specifically, when the button 332 is pressed, the outer tube releases the lock on the movement of the guide tube control cylinder 333 relative to the outer tube control cylinder 335. The outer tube control cylinder 335 is attached to the outer tube 102. The transition part 338 relaxes the connection tension between the outer tube control cylinder 335 and the outer tube 102 to avoid torsion. The guide tube cylinder 333 is attached to the intermediate tube 103 in FIGS. 2-7, and the intermediate tube 103 is connected to the guide tube 115 in FIGS. 2-10. The guide tube control mechanism 330 enables the user of the PTAC 100 to control the movement of the guide tube 115 distally and proximally, and includes the button 332 and the guide tube control cylinder 333. The injection needle control mechanism 340 enables the user of the PTAC 100 to control the movement of the injection tube 116 having the distal injection needle 119 distally and proximally, and includes the button 342 and the needle control cylinder 345.

[0120] When the button 342 is depressed, it releases the lock on the movement of the needle control cylinder 345 relative to the guide tube control cylinder 333. This allows for relative longitudinal movement of the inner tube 105 with respect to the intermediate tube 103 in FIGS. 3-7, enabling the injection tube 116 having the distal injection needle 119 to advance and retract through the guide tube 115. The handle 300 shown in FIG. 11 has a flushing port 344. Normally, the movement of the injection tube 116 having the distal injection needle 119 distally and proximally, and includes the button 342 and the needle control cylinder 345. When the button 342 is depressed, it releases the lock on the movement of the needle control cylinder 345 relative to the guide tube control cylinder 333. This allows for relative longitudinal movement of the inner tube 105 with respect to the intermediate tube 103 in FIGS. 3-7, enabling the injection tube 116 having the distal injection needle 119 to advance and retract through the guide tube 115.

[0121] When the button 342 is depressed, it releases the lock on the movement of the needle control cylinder 345 relative to the guide tube control cylinder 333. This allows for relative longitudinal movement of the inner tube 105 with respect to the intermediate tube 103 in FIGS. 3-7, enabling the injection tube 116 having the distal injection needle 119 to advance and retract through the guide tube 115. This allows for relative longitudinal movement of the inner tube 105 with respect to the intermediate tube 103 in FIGS. 3-7, enabling the injection tube 116 having the distal injection needle 119 to advance and retract through the guide tube 115. The handle 300 shown in FIG. 11 has a flushing port 344. Normally, the injection tube 116 having the distal injection needle 119 can advance and retract through the guide tube 115.

[0122] The handle 300 shown in FIG. 11 has a flushing port 344. Normally, The flushing port 344, which has a Luer connector, is shown with the cap 346. The flushing port 344 is used to flush the annular gaps 137 and 139 shown in FIGS. 5 and 6 with physiological saline. The injection port 354, which typically has a cauterizing fluid connector, is shown with the cap 356. The injection port 354 enables the injection of the cauterizing fluid into the lumen 133 of FIGS. 3 and 5, and the lumen 133 is in fluid communication with the lumen of the injection tube 116, and the lumen of the injection tube 116 is in fluid communication with the needle distal opening 117.

[0123] FIG. 11 shows one flushing port 344, but it is also contemplated to use two or more flushing ports to flush the internal space (other than the injection lumen) within the PTAC 100. It is also contemplated to replace the two buttons 332 and 342 with a single button and a cylinder mechanism. In that case, the telescoping mechanism within the proximal portion of the PTAC 100 advances the guide tube 115 when the single button is pressed, and then advances the injection tube 116 having the distal injection needle 119. Releasing the depression of the single button first retracts the distal injection needle 119 and then retracts the guide tube 115.

[0124] A standard Luer connector or Luer lock connector can be used for the cauterizing fluid connector of the injection port 354, but it is a preferred feature of the PTAC 100 disclosed in this specification to use a specially designed connector for the injection of the cauterizing fluid. Since the cauterizing fluid is cauterizing / toxic, using a specially designed connector for the injection port 354 can prevent spillage within one or more injection ports (e.g., 344) or within a standard Accidental injection of ablation fluid into the Luer connector is reduced. The operator accidentally injects the flushing fluid or other drugs in the standard L uer lock syringe through the lumen of the injection tube is also prevented. It is also an advantage that a special connection port with a lumen smaller than the lumen of the standard Luer connector that minimizes the dead space / inner volume of the catheter can be used One of the advantages is that a special connection port with a lumen smaller than the lumen of the standard Luer connector that minimizes the dead space / inner volume of the catheter can be used is also an advantage that a special connection port with a lumen smaller than the lumen of the standard Luer connector that minimizes the dead space / inner volume of the catheter can be used

[0125] A special syringe having a special connector designed to connect to the injection port 354 is provided in a package separate from the PTAC 100 or in the same package. Such a syringe can accurately contain a suitable amount of ablation fluid, such as 0.25 mL of ethanol, to achieve renal denervation in a package separate from the PTAC 100 or in the same package. Such a syringe can accurately contain a suitable amount of ablation fluid, such as 0.25 mL of ethanol, to achieve renal denervation Since the volume of the tissue to be treated varies with the diameter of the renal artery, several syringes with inner volumes ranging from 0.1 mL to 0.5 mL and each having a special connector connecting to the injection port 3 54 are provided. When flushing with saline or when the injection of other liquids (e.g., contrast agent or anesthetic) is part of the procedure, additional syringes containing suitable amounts and types of liquids for visualization, flushing, renal denervation, or pain relief are provided. The ablation fluid injection syringe having a special connector has a color or marking different from that of the syringe for flushing through ports such as the injection port 354 or when the injection of other liquids (e.g., contrast agent or anesthetic) is part of the procedure, additional syringes containing suitable amounts and types of liquids for visualization, flushing, renal denervation, or pain relief are provided. The ablation fluid injection syringe having a special connector has a color or marking different from that of the syringe for flushing through ports such as the injection port 354 is expected to have a color or marking different from that of the syringe for flushing through ports such as the injection port 354 is expected to have a color or marking different from that of the syringe for flushing through ports such as the injection port 354 is expected to have a color or marking different from that of the syringe for flushing through ports such as the injection port 354 is expected to have a color or marking different from that of the syringe for flushing through ports such as the injection port 354

[0126] The handle 300 also has an adjustment cylinder 348 shown in FIG. 4 that reduces the penetration depth L2, which is the distance between the injection needles 119 extending beyond the distal end 129 of the guide tube 115 when rotated in one direction The handle 300 also has an adjustment cylinder 348 shown in FIG. 4 that reduces the penetration depth L2, which is the distance between the injection needles 119 extending beyond the distal end 129 of the guide tube 115 when rotated in one direction increases if the cylinder 348 rotates in the other direction increases. The PTAC 1 having markings on the handle 300 indicating the achievable intervals is assumed to be accessible to the user of 00 for the interval adjustment cylinder 348. In a preferred embodiment of the handle 300, the interval adjustment cylinder 348 is accessible only during the assembly and testing of the PT AC 100 at the factory. This manufacturing method ensures a suitable calibration of the penetration depth L2 shown in FIG. 4, and the penetration depth L2 is preset at the factory during the manufacturing and testing of each PTAC 100. The ability to accurately set and calibrate the penetration depth L2 is critically important for improving manufacturing yield. In other words, even if the relative lengths of the components of the PTAC 100, such as the inner tube 1 05 and the intermediate tube 103, vary by several millimeters , the penetration depth L2 can be accurately adjusted using the interval adjustment cylinder 348. In this preferred embodiment, the PTAC 100 is provided with an indication according to the penetration depth L2 shown in FIG. 4. For example, the penetration depth L2 of the PTAC 100 is of three types: 2.5 mm, 3 mm , and 3.5 mm. It is also envisaged to lock the interval adjustment cylinder 348 set to the desired penetration depth using a thread or other mechanism (not specifically shown). Although the interval adjustment cylinder 348 is shown in this specification, it is also envisaged to use other mechanisms such as a moving cylinder for the adjustment of the penetration depth L 2. The function of the handle 300 is to operate the PTAC 100 for perivascular renal denervation (PVRD). This procedure includes the following steps, although each step is not essential and can be shortened or modified as would be understood by a person skilled in the art: 1) Through ports 344 and 354, fill the entire internal volume of the PTAC 100 with physiological saline

[0127] 1) Through ports 344 and 354, fill the entire internal volume of the PTAC 100 with physiological saline Rush. 2) Insert the PTAC 100 through the pre - placed guide catheters 140 of FIGS. 8 - 10 and place the distal portion of the PTAC 100 shown in FIG. 8 at the desired site within the patient's renal artery. 3) While holding the outer tube control cylinder 335 locked to the guide tube control cylinder 333 by pressing the button 332, push the guide tube control cylinder 333 distally until the notch 331 engages the port 344 and restricts the advancement of the intermediate tube 103 in FIG. 5. As shown in FIG. 9, fully deploy the guide tube 115 outward through the opening 131 from the inside of the hollow shaft 120. 4) When the button 332 is released, the relative movement of the outer tube control cylinder 335 with respect to the guide tube control cylinder 333 is locked again. 5) When the button 342 is pressed, the relative movement of the injection needle control cylinder 345 with respect to the guide tube control cylinder 333 becomes possible. While holding the outer tube control cylinder 335 (which is now locked to the guide tube control cylinder 333), advance the injection needle control cylinder 345 having the distal end 349 until the pre - set penetration depth L2 of the needle 119 with respect to the distal end 129 of the guide tube 115 is achieved. There are two ways to do this: 1) Advance the distal end 349 of the injection needle control cylinder 345 until it engages the guide tube flush port 344. Or 2) Approach the internal spacing 347 to the proximal end of the spacing adjustment cylinder 348 inside the injection needle control cylinder 345. 6) When the finger is released from the button 342, the injection into the guide tube control cylinder 333 the relative movement of the needle control cylinder 345 is locked again. Here, the PTAC 100 is in the arrangement shown in FIG. 10, and the needle 119 penetrates the inner elastic membrane (IEL) and from the IEL by a preset distance (usually 0.5 mm to 4 mm, preferably approximately 2 mm to 4 mm) only penetrates into the arterial wall of the renal artery. If the penetration depth is 2 mm to 3 mm, the intima and media of the renal artery are minimally damaged. For some abnormal target vessels, a penetration depth as large as 8 mm is required. 7) In this state, an injector or a connecting tube with an injector (not shown) is attached to the port 354 , and a desired amount of cauterizing solution is injected. This cauterizing agent can be ethanol (ethyl alcohol), distilled water, hypertonic saline, hypotonic saline, phenol, glycerol, lidocaine, bupivacaine, tetracaine, benzocaine, guanethidine, botulinum toxin, glycoside, or any suitable neurotoxic solution such as a cauterizing solution. For this injection, two or more neurocauterizing solutions or local anesthetics are combined in the space inside and / or immediately outside the arterial wall and injected together or continuously (with the local anesthetic that reduces discomfort first, followed by delivering the cauterizing agent ), and / or injection of a high-temperature liquid (or steam), or a very low-temperature (for cryoablation) liquid can be included. The normal injection volume is 0.1 mL to 5.0 mL. As a result, multiple cauterizing regions (one for each injection tube / injection needle) that cross and form a cauterizing ring around the circumference of the target vessel are generated. A contrast agent that enables visualization of the cauterizing region by X-ray can be added either during the test injection before the neurocauterizing agent injection or during the therapeutic injection. When ethanol is used as the cauterizing agent, an amount less than 0.5 mL is sufficient. This is because not only is the necessary space containing the sympathetic nerves completely filled, but also the amount is small enough not to damage the patient's kidneys even if it is accidentally released into the renal artery. Ideally, 0.1 m L to 0.3 mL of ethanol is used. The amount used may be the same for all renal arteries or it can be varied according to the diameter of the renal artery into which the ethanol is injected. Since ethanol is hydrophilic and lipophilic, diffusion is promoted and it is effective even in such a small amount. Before injecting the cauterizing agent or solution, it is desirable to fluoroscopically confirm that the needle 119 in FIGS. 2 to 4 has been deployed into the vessel wall of the target vessel. 8) Next, replace the syringe containing the cauterizing solution with a syringe containing physiological saline and attach it to the port 354. Ideally, inject an amount of physiological saline slightly more than the total dead volume to ensure that no cauterizing solution remains in the PTAC 100. For example, if the dead volume in the PTAC 100 is 0.1 mL, inject, for example, 0.1 mL to 0.15 mL of physiological saline so that all of the cauterizing solution is reliably delivered to the appropriate perivascular tissue through the distal opening 117 of the injection needle 119 in FIG. 10. 9) Press the button 342 and while holding the outer tube control cylinder 335, pull the injection needle control cylinder 345 proximally until the injection needle 119 has completely retracted into the guide tube 115. When the injection needle control cylinder 345 reaches the correct position and the injection needle 119 is fully retracted, it is assumed that there will be a clicking sound or it will stop. 10) When the finger is released from the button 342, the movement of the injection needle control cylinder 345 with respect to the guide tube control cylinder 333 is locked. ​​​​​11) When button 332 is pressed, the relative movement of the outer tube control cylinder 335 with respect to the guide tube control cylinder 333 becomes possible, and it is locked with respect to the injection needle control cylinder 345. 12) The guide tube control cylinder 333 is retracted proximally with respect to the outer tube control cylinder 335. As a result, the guide tube 115 in the form of FIG. 9 retracts inside the opening 131 in the outer tube extension 104 of the PTAC 100. 13) The PTAC 100 is pulled back into the guide catheter 140. 14) The guide catheter 140 is moved to another renal artery. 15) For another renal artery, steps 3 to 13 are repeated. 16) The PTAC 100 is removed from the patient's body. 17) It is highly desirable to eliminate step 8 and, in step 1, outside the patient's body, instead of physiological saline, flush the internal volume / dead space with a cauterizing solution. This is considered to be done with the guide tube 115 and the needle 119 in a fully deployed state. Any cauterizing solution remaining on the surface during flushing with the cauterizing solution is removed from the surface of the PTAC 100. Therefore, it is also desirable that this technique be used for flushing the distal part of the PTAC 100 with physiological saline prior to the advancement of the catheter into the patient's body. 18) As described above, buttons 332 and 342 enable the movement of the control cylinders when pressed and locked and when the finger is released. However, as described below, it is also assumed that they are interlocked: 19) The first interlock is that the guide tube control cylinder 333 is at its most distal part. 20) When button 332 is pressed, the outer tube control cylinder 335 moves proximally relative to the guide tube control cylinder 333, and the injection needle control cylinder 345 is locked.

[0128] 21) When button 342 is pressed, the outer tube control cylinder 335 moves distally relative to the guide tube control cylinder 333, and the injection needle control cylinder 345 is unlocked. 22) When button 342 is released, the outer tube control cylinder 335 moves proximally relative to the guide tube control cylinder 333, and the injection needle control cylinder 345 is locked. 23) When button 332 is released, the outer tube control cylinder 335 moves distally relative to the guide tube control cylinder 333, and the injection needle control cylinder 345 is unlocked. 24) The above interlock is preferably achieved by a mechanical connection between the buttons 332 and 342 and the control cylinders. 25) The mechanical connection can be a cable, a rod, or other suitable means. 26) The mechanical connection ensures that the movement of one button is transmitted to the corresponding control cylinder and that the interlock relationship is maintained.

[0129] As described above, buttons 332 and 342 enable the movement of the control cylinders when pressed and locked and when the finger is released. However, as described below, it is also assumed that they are interlocked as follows: 1. The first interlock is that the guide tube control cylinder 333 is at its most distal part. 2. When button 332 is pressed, the outer tube control cylinder 335 moves proximally relative to the guide tube control cylinder 333, and the injection needle control cylinder 345 is locked. 3. When button 342 is pressed, the outer tube control cylinder 335 moves distally relative to the guide tube control cylinder 333, and the injection needle control cylinder 345 is unlocked. Only when the outer tube 102 is retracted and the guide tube 115 is fully deployed is it possible to unlock the injection needle control cylinder 345. 2. The second interlock is that the injection needle control cylinder 345 is at its most distal position and the needle 11 9 is retracted into the guide tube 115, only then is it possible to unlock the guide tube control cylinder 333. The combination of the above control mechanism with buttons 332 and 342 makes the method of using the PTAC 100 reasonably simple and easy. Basically, when the operator presses the button 332, the guide tube control cylinder 333 advances and the guide tube 115 expands outward. When the button 342 is pressed, the needle 119 advances and penetrates the inner wall of the renal artery. Injection is performed. Then, when the button 342 is pressed again, the opposite procedure is carried out, the needle 119 retracts, and when the button 332 is pressed further, the guide tube control cylinder 333 retracts proximally to retract the guide tube 115 into the body of the PTAC 100.

[0130] The operation of the handle by pressing the button and the longitudinal pushing or pulling of each part to deploy the guide tube and the needle are shown in FIG. 11, but other techniques such as a rotation mechanism for locking or longitudinal movement are also assumed to be usable. Incorporated herein by reference in its entirety as part of this specification is U.S. Patent Application No. 13 / 643,070 filed on October 23, 2012 by Fischell et al., in which FIG. 33 shows such a rotation locking mechanism.

[0131] As described in step 8 of the above method, flushing the injection lumen with saline and then filling it ensures that no toxic cauterizing fluid is accidentally introduced into the renal artery during treatment. There are advantages, but there is another technique made possible by the low dead space PTAC 100. Specifically, if the dead space is small and the ablation fluid is ethanol, hypertonic saline, or hypotonic saline, the dead space can be filled with the ablation fluid outside the patient's body. Since it is mixed with a large amount of blood going to the kidney, injecting 0.5 mL of ethanol, hypertonic saline, or hypotonic saline directly will not damage the kidney. From this concept, the flushing step after ablation fluid injection is reduced, and the injection step during the treatment procedure is reduced from two times per artery to one time per artery. For example, if the dead space is 0.1 mL and the desired amount of ethanol is 0.2 mL, the dead space can be filled outside the patient's body with 0.1 mL of ethanol. Then, the catheter and needle are deployed into the first renal artery. Next, when 0.2 mL of additional ethanol is injected, 0.2 mL will be delivered into the perivascular space and 0.1 mL will remain in the dead space. The needle 119 and guide tube 115 are retracted, the PTAC 100 is deployed in another renal artery, and another 0.2 mL of ethanol is injected. The needle 119 and guide tube 115 are retracted, and the PTAC 100 is removed from the patient's body. In this ablation procedure, the amount of ethanol leaking into the renal artery is very small (less than 0.05 mL), and even 10 times this amount will not damage the kidney. Another advantage of this method of reducing steps is that only the ablation fluid is delivered into the perivascular space, so in the above procedure, "dilution" of the ablation fluid by the saline delivered first

[0132] before the ablation fluid is delivered is suppressed. By fixing the lid 356 on the connector for the injection port 354, it is also necessary to pay attention to preventing the cauterizing liquid from entering the renal artery while the PTAC 100 is inserted into the renal artery. Also, when the PTAC 100 moves from one renal artery to the opposite renal artery, by arranging such a sealing lid 356 on the connector for the injection port 354, it is also prevented that the cauterizing liquid enters the second renal artery. The lid 356 is also fixed on the connector for the injection port 354 when the PTAC 100 is removed from the patient's body. During the renal denervation procedure, the lid 356 is removed only for injecting the cauterizing liquid into the perivascular space of the vessel to be treated.

[0133] The plug attached to the injection port 354 can also prevent the cauterizing liquid from leaking from the distal opening 117 of the needle in FIGS. 2 to 10 when closed. Of course, in reality, when the PTAC 100 moves within the arterial system of the patient's body, if the lid 356 is not attached, any liquid in the injection lumen of the PTAC 100 will come out of the injection port 354 due to the blood pressure in the arterial system.

[0134] It is also possible to combine the presence or absence of the flushing step. For example, the cauterizing liquid can be pre-injected into the dead space of the PTAC 100, and after deploying the needle 119 and the guide tube 115, the cauterizing liquid can be flushed out of the perivascular space with physiological saline. After injecting the cauterizing liquid into the perivascular space, the needle 119 and the guide tube 115 can be retracted outside the perivascular space, filling the dead space with the cauterizing liquid again and flushing it out of the dead space with physiological saline. Then, other renal arteries can be treated.

[0135] The PTAC 100 is in a state where the guide tube 115 is fully expanded and the injection tube is fully retracted. ​​​​​​​​​​​​It can be packaged together with the tube 116. The reason for this is that the guide tube is preferably made of plastic such as polyimide and is formed into a curved shape. This is because such a plastic material may be linearly deformed by the hollow shaft 120 when it is packaged and retracted into the hollow shaft 120. The injection tube 116 having the needle 119 at its distal end can also be shipped with the device in a fully expanded state. In this way, the shapes of the guide tube 115 and the injection tube 116 are best maintained. In this case, to ensure that the handler is not pricked by the needle, the device is shipped in a protective container. It should also be understood that the handle 300 of FIG. 11 has a distal portion, the distal portion has a tapered protruding structure 338, the tapered protruding structure 338 is attached to the hypo tube 82, and the hypo tube 82 extends for most of the entire length of the PTAC 100. As shown in FIG. 18, the hypo tube 82 is connected to the tube 92, and the tube 92 is connected to the outer tube 102 of the PTAC 100. Usually, the hypo tube is made of the same type of metal as the subcutaneous injection needle, that is, generally stainless steel. It should also be understood that the handle 300 of FIG. 11 has a distal portion, the distal portion has a tapered protruding structure 338, the tapered protruding structure 338 is attached to the hypo tube 82, and the hypo tube 82 extends for most of the entire length of the PTAC 100. As shown in FIG. 18, the hypo tube 82 is connected to the tube 92, and the tube 92 is connected to the outer tube 102 of the PTAC 100. Usually, the hypo tube is made of the same type of metal as the subcutaneous injection needle, that is, generally stainless steel. It should also be understood that the handle 300 of FIG. 11 has a distal portion, the distal portion has a tapered protruding structure 338, the tapered protruding structure 338 is attached to the hypo tube 82, and the hypo tube 82 extends for most of the entire length of the PTAC 100. As shown in FIG. 18, the hypo tube 82 is connected to the tube 92, and the tube 92 is connected to the outer tube 102 of the PTAC 100. Usually, the hypo tube is made of the same type of metal as the subcutaneous injection needle, that is, generally stainless steel. It should also be understood that the handle 300 of FIG. 11 has a distal portion, the distal portion has a tapered protruding structure 338, the tapered protruding structure 338 is attached to the hypo tube 82, and the hypo tube 82 extends for most of the entire length of the PTAC 100. As shown in FIG. 18, the hypo tube 82 is connected to the tube 92, and the tube 92 is connected to the outer tube 102 of the PTAC 100. Usually, the hypo tube is made of the same type of metal as the subcutaneous injection needle, that is, generally stainless steel.

[0136] It should also be understood that the handle 300 of FIG. 11 has a distal portion, the distal portion has a tapered protruding structure 338, the tapered protruding structure 338 is attached to the hypo tube 82, and the hypo tube 82 extends for most of the entire length of the PTAC 100. As shown in FIG. 18, the hypo tube 82 is connected to the tube 92, and the tube 92 is connected to the outer tube 102 of the PTAC 100. Usually, the hypo tube is made of the same type of metal as the subcutaneous injection needle, that is, generally stainless steel. It should also be understood that the handle 300 of FIG. 11 has a distal portion, the distal portion has a tapered protruding structure 338, the tapered protruding structure 338 is attached to the hypo tube 82, and the hypo tube 82 extends for most of the entire length of the PTAC 100. As shown in FIG. 18, the hypo tube 82 is connected to the tube 92, and the tube 92 is connected to the outer tube 102 of the PTAC 100. Usually, the hypo tube is made of the same type of metal as the subcutaneous injection needle, that is, generally stainless steel. It should also be understood that the handle 300 of FIG. 11 has a distal portion, the distal portion has a tapered protruding structure 338, the tapered protruding structure 338 is attached to the hypo tube 82, and the hypo tube 82 extends for most of the entire length of the PTAC 100. As shown in FIG. 18, the hypo tube 82 is connected to the tube 92, and the tube 92 is connected to the outer tube 102 of the PTAC 100. Usually, the hypo tube is made of the same type of metal as the subcutaneous injection needle, that is, generally stainless steel. It should also be understood that the handle 300 of FIG. 11 has a distal portion, the distal portion has a tapered protruding structure 338, the tapered protruding structure 338 is attached to the hypo tube 82, and the hypo tube 82 extends for most of the entire length of the PTAC 100. As shown in FIG. 18, the hypo tube 82 is connected to the tube 92, and the tube 92 is connected to the outer tube 102 of the PTAC 100. Usually, the hypo tube is made of the same type of metal as the subcutaneous injection needle, that is, generally stainless steel. It should also be understood that the handle 300 of FIG. 11 has a distal portion, the distal portion has a tapered protruding structure 338, the tapered protruding structure 338 is attached to the hypo tube 82, and the hypo tube 82 extends for most of the entire length of the PTAC 100. As shown in FIG. 18, the hypo tube 82 is connected to the tube 92, and the tube 92 is connected to the outer tube 102 of the PTAC 100. Usually, the hypo tube is made of the same type of metal as the subcutaneous injection needle, that is, generally stainless steel. It should also be understood that the handle 300 of FIG. 11 has a distal portion, the distal portion has a tapered protruding structure 338, the tapered protruding structure 338 is attached to the hypo tube 82, and the hypo tube 82 extends for most of the entire length of the PTAC 100. As shown in FIG. 18, the hypo tube 82 is connected to the tube 92, and the tube 92 is connected to the outer tube 102 of the PTAC 100. Usually, the hypo tube is made of the same type of metal as the subcutaneous injection needle, that is, generally stainless steel.

[0137] FIG. 12 is a longitudinal sectional view of another embodiment of the PTAC 200 having a self-expanding guide tube 215 supported by an intraluminal central placement mechanism (ICM) 250. The ICM 250 assists in the uniformity of the expansion of the self-expanding guide tube 215 and further supports the guide tube 215. The central portion 204 of the ICM 250 provides a larger surface for opening against the inner wall of the target vessel, and the distal end 229 of the guide tube 215 is within the target vessel. FIG. 12 is a longitudinal sectional view of another embodiment of the PTAC 200 having a self-expanding guide tube 215 supported by an intraluminal central placement mechanism (ICM) 250. The ICM 250 assists in the uniformity of the expansion of the self-expanding guide tube 215 and further supports the guide tube 215. The central portion 204 of the ICM 250 provides a larger surface for opening against the inner wall of the target vessel, and the distal end 229 of the guide tube 215 is within the target vessel. FIG. 12 is a longitudinal sectional view of another embodiment of the PTAC 200 having a self-expanding guide tube 215 supported by an intraluminal central placement mechanism (ICM) 250. The ICM 250 assists in the uniformity of the expansion of the self-expanding guide tube 215 and further supports the guide tube 215. The central portion 204 of the ICM 250 provides a larger surface for opening against the inner wall of the target vessel, and the distal end 229 of the guide tube 215 is within the target vessel. FIG. 12 is a longitudinal sectional view of another embodiment of the PTAC 200 having a self-expanding guide tube 215 supported by an intraluminal central placement mechanism (ICM) 250. The ICM 250 assists in the uniformity of the expansion of the self-expanding guide tube 215 and further supports the guide tube 215. The central portion 204 of the ICM 250 provides a larger surface for opening against the inner wall of the target vessel, and the distal end 229 of the guide tube 215 is within the target vessel. FIG. 12 is a longitudinal sectional view of another embodiment of the PTAC 200 having a self-expanding guide tube 215 supported by an intraluminal central placement mechanism (ICM) 250. The ICM 250 assists in the uniformity of the expansion of the self-expanding guide tube 215 and further supports the guide tube 215. The central portion 204 of the ICM 250 provides a larger surface for opening against the inner wall of the target vessel, and the distal end 229 of the guide tube 215 is within the target vessel. When being displaced by the wall or when the injection tube 216 having the distal injection needle 219 advances through the inner wall of the target blood vessel, its lateral movement is prevented. Similar to the PTAC 100 shown in FIGS. 2-11, the guide tube 215 is a needle guiding element, and when the injection tube 216 having the injection needle 219 advances through the inner wall of the target blood vessel, it expands outwardly to support / back up the injection needle 219 at the distal end of the injection tube 216. This support or backup is an important feature of another embodiment of the PTAC 200 as shown in FIG. 12 compared to the embodiment of the PTAC 50 shown in FIG. 1. The PTAC 200 shown in FIG. 12 includes a support 220 having a proximal portion 223, a distal tapered portion 226, and a radiopaque marker band 224. The distal side of the distal tapered portion 226 is the fixed guide wire 210 having the core wire 211 and the outer layer 228. The radiopaque wires 218 within the lumen of each injection tube 216 increase the radiopacity of the injection tubes 216 such that their placement is visible under fluoroscopy. When the injection tube 216 having the distal injection needle 219 advances through the inner wall of the target blood vessel, its lateral movement is prevented. Similar to the PTAC 100 shown in FIGS. 2-11, the guide tube 215 is a needle guiding element, and when the injection tube 216 having the injection needle 219 advances through the inner wall of the target blood vessel, it expands outwardly to support / back up the injection needle 219 at the distal end of the injection tube 216. Similar to the PTAC 100 shown in FIGS. 2-11, the guide tube 215 is a needle guiding element, and when the injection tube 216 having the injection needle 219 advances through the inner wall of the target blood vessel, it expands outwardly to support / back up the injection needle 219 at the distal end of the injection tube 216. Similar to the PTAC 100 shown in FIGS. 2-11, the guide tube 215 is a needle guiding element, and when the injection tube 216 having the injection needle 219 advances through the inner wall of the target blood vessel, it expands outwardly to support / back up the injection needle 219 at the distal end of the injection tube 216. Similar to the PTAC 100 shown in FIGS. 2-11, the guide tube 215 is a needle guiding element, and when the injection tube 216 having the injection needle 219 advances through the inner wall of the target blood vessel, it expands outwardly to support / back up the injection needle 219 at the distal end of the injection tube 216. This support or backup is an important feature of another embodiment of the PTAC 200 as shown in FIG. 12 compared to the embodiment of the PTAC 50 shown in FIG. 1. This support or backup is an important feature of another embodiment of the PTAC 200 as shown in FIG. 12 compared to the embodiment of the PTAC 50 shown in FIG. 1. The PTAC 200 shown in FIG. 12 includes a support 220 having a proximal portion 223, a distal tapered portion 226, and a radiopaque marker band 224. The PTAC 200 shown in FIG. 12 includes a support 220 having a proximal portion 223, a distal tapered portion 226, and a radiopaque marker band 224. The distal side of the distal tapered portion 226 is the fixed guide wire 210 having the core wire 211 and the outer layer 228. The distal side of the distal tapered portion 226 is the fixed guide wire 210 having the core wire 211 and the outer layer 228. The radiopaque wires 218 within the lumen of each injection tube 216 increase the radiopacity of the injection tubes 216 such that their placement is visible under fluoroscopy. The radiopaque wires 218 within the lumen of each injection tube 216 increase the radiopacity of the injection tubes 216 such that their placement is visible under fluoroscopy. The radiopaque wires 218 within the lumen of each injection tube 216 increase the radiopacity of the injection tubes 216 such that their placement is visible under fluoroscopy.

[0138] The PTAC 200 of FIG. 12 has four guide tubes 215 together with four concentric injection tubes 216. Ideally, three to five needles are used for renal denervation. The PTAC 200 of FIG. 12 has four guide tubes 215 together with four concentric injection tubes 216. Ideally, three to five needles are used for renal denervation. When ethanol is used as the ablation solution for nerve ablation, three needles are sufficient. This is because ethanol is hydrophilic, i.e., ethanol easily diffuses into human tissue. When ethanol is used as the ablation solution for nerve ablation, three needles are sufficient. This is because ethanol is hydrophilic, i.e., ethanol easily diffuses into human tissue. When ethanol is used as the ablation solution for nerve ablation, three needles are sufficient. This is because ethanol is hydrophilic, i.e., ethanol easily diffuses into human tissue.

[0139] The core wire 211 is connected to the central portion of the PTAC 200 and extends distally to form the center of the fixed guide wire 210. The fixed wire and the guide wire The core wire 211 is connected to the central portion of the PTAC 200 and extends distally to form the center of the fixed guide wire 210. The fixed wire and the guide wire The formation is well known in the field of medical devices.

[0140] The ICM250 includes a central portion 204 having a distal ring 202, support struts 208, and radiopaque markers 206. The ICM250 additionally supports the guide tube 215 radially and circumferentially / transversely during expansion and while the injection tube 216 advances through the guide tube 215. The outer side of the central portion 204 also has a small but flat or slightly curved surface that engages or contacts the inner wall of the target vessel, reducing trauma to the vessel wall compared to when the distal end of the guide tube 215 contacts the inner wall of the target vessel. As can be seen from FIG. 12, the surface of the central portion 204 contacts the vessel wall before the distal end of the guide tube 215 contacts the inner wall of the target vessel. For this reason, a larger surface contacts the vessel wall, reducing the likelihood that the distal end 229 of the guide tube 215 will damage the inner wall of the target vessel. As shown in FIGS. 12 and 13, it is envisioned that there are several techniques for forming the structure of the guide tube 215 attached to the distal side of the ICM250. One technique is to form the shape shown in FIG. 12 using a nitinol tube. If this shape is heat treated, material can be removed by machining to expose the distal end 229 of the guide tube 215. In a second machining method, half of the guide tube 215 is removed and the portion of the ICM250 of the PTAC 200 is set to approximately 90° to 270°. The radiopaque plug 206 is attached within the horizontal portion 204 and the distal end of the ICM250 is attached to the distal ring 202.

[0141]

[0142] ​​​​​​​​​​In another technique, the guide tube 215 is made of plastic, and a Nitinol wire has three parts, a proximal part attached to the plastic guide tube, a smooth and flat central part, and a distal curved ICM part. The proximal part is attached to the plastic guide tube, the smooth and flat central part, and the distal curved ICM part. It has a proximal part attached to the plastic guide tube, a smooth and flat central part, and a distal curved ICM part.

[0143] Figure 12 shows a sheath 212 having a radiopaque marker band 213 that is retracted to its proximal position, i.e., the opening position, so that the self-expanding guide tube 215 can expand outward. The radiopaque plug 206 enables fluoroscopic visualization to confirm a suitable expansion near and / or very close to the inner wall of the target vessel of the guide tube 215. The injection tube 216 having a distal injection needle 219 and a distal opening 217 advances through the guide tube 215 and penetrates the inner wall of the target vessel. Then, the ablation liquid is injected into the perivascular space through the needle distal opening 217. Thereafter, the injection tube 216 retracts into the guide tube 215, and the sheath 212 advances distally to fold and accommodate the guide tube 215 and the ICM 250. When the radiopaque marker band 213 near the distal end of the sheath 212 is in contact with the radiopaque marker band 224 on the support 220, the operator can confirm that the PTAC 200 is in its contracted position and retracts it into the guide catheter. The radiopaque plug 206 enables fluoroscopic visualization to confirm a suitable expansion near and / or very close to the inner wall of the target vessel of the guide tube 215. The radiopaque plug 206 enables fluoroscopic visualization to confirm a suitable expansion near and / or very close to the inner wall of the target vessel of the guide tube 215. The radiopaque plug 206 enables fluoroscopic visualization to confirm a suitable expansion near and / or very close to the inner wall of the target vessel of the guide tube 215. The injection tube 216 having a distal injection needle 219 and a distal opening 217 advances through the guide tube 215 and penetrates the inner wall of the target vessel. The injection tube 216 having a distal injection needle 219 and a distal opening 217 advances through the guide tube 215 and penetrates the inner wall of the target vessel. The injection tube 216 having a distal injection needle 219 and a distal opening 217 advances through the guide tube 215 and penetrates the inner wall of the target vessel. Then, the ablation liquid is injected into the perivascular space through the needle distal opening 217. Thereafter, the injection tube 216 retracts into the guide tube 215, and the sheath 212 advances distally to fold and accommodate the guide tube 215 and the ICM 250. Thereafter, the injection tube 216 retracts into the guide tube 215, and the sheath 212 advances distally to fold and accommodate the guide tube 215 and the ICM 250. The radiopaque marker band 213 near the distal end of the sheath 212 is in contact with the radiopaque marker band 224 on the support 220. The radiopaque marker band 213 near the distal end of the sheath 212 is in contact with the radiopaque marker band 224 on the support 220. When the radiopaque marker band 213 near the distal end of the sheath 212 is in contact with the radiopaque marker band 224 on the support 220, the operator can confirm that the PTAC 200 is in its contracted position and retracts it into the guide catheter. When the radiopaque marker band 213 near the distal end of the sheath 212 is in contact with the radiopaque marker band 224 on the support 220, the operator can confirm that the PTAC 200 is in its contracted position and retracts it into the guide catheter.

[0144] Figure 13 is an enlarged longitudinal sectional view of region S13 in Figure 12, showing the structure of the fully deployed PTAC 200. The injection tube 216 having a distal injection needle 219, the needle distal opening 217, and the radiopaque wire 218 are attached to the ICM 250 having a guide tube. The injection tube 216 having a distal injection needle 219, the needle distal opening 217, and the radiopaque wire 218 are attached to the ICM 250 having a guide tube. The injection tube 216 having a distal injection needle 219, the needle distal opening 217, and the radiopaque wire 218 are attached to the ICM 250 having a guide tube. 2. The distal end 229 of the guide tube 215 is shown advancing coaxially therefrom. The CM 250 has a central portion 204 having a radiopaque marker 206. The portion 204 is fixedly attached to the guide tube 215 on the distal end of the guide tube 215. The central portion 204 is integrally formed with a support post 208. , connected at the distal end of the core 204, as shown in FIG.

[0145] The guide tube 215, the central structure 204, and the support struts 208 are made of a shape memory alloy or It is made of a resilient metal such as tinol, specifically the embodiment shown in Figures 12 and 13. In this study, a single tube of Nitinol was machined, bent, and heat treated to produce the shape shown in Figure 1. 2 and 13. The guide tube 215 is the same as the central portion 204. The central portion 204 is cylindrical and has a radiopaque marker 206 attached thereto. The support post 208 has a portion of the cylinder removed.

[0146] The guide tube 215 may be made of plastic as shown in FIGS. The plastic may be a round or flat plastic that is attached to the guide tube 215. The flat Nitinol wire enhances the self-expanding properties of the plastic, making it ideal for IC It is also envisioned that the guide tube 21 extends distally from the support post 208 of the guide tube 21. Different variations in the structure of the 5 are available to make the guide tube more flexible. For example, it is contemplated that the guide tube 215 may be spirally aligned along its length. The image was cut out using a laser.

[0147] Figure 14 is an enlarged longitudinal sectional view of region S14 of the PTAC 200 of FIG. 12. FIG. 14 shows a sheath 212 having a distal radiopaque marker band 213. A guide tube 215, an injection tube 216, a radiopaque wire 218, and a core wire 2 11 are also shown. The central and proximal portions of the PTAC 200 are shown in the prior art disclosures, U.S. Patent Application Nos. 13 / 294,439, and 13 / 342,521. This includes a mechanism near the proximal end of the PTAC 200 that allows the operator to expand the guide tube 215 outwardly towards the inner wall of the target vessel. Also included herein is a mechanism for controlling the advancement of an injection tube 216 having a distal injection needle 219 into the inner wall of the target vessel through the guide tube 215.

[0148] Fischell et al. show in U.S. Patent Application No. 13 / 643,070 several handle / proximal configurations specifically designed to release a self-expanding guide tube and advance an injection needle into the adventitia of the target vessel or deep (outside the adventitia). Such designs function well in conjunction with the PTAC 200 of FIGS. 12 - 14.

[0149] The PTAC 200 of FIGS. 12 - 14 shows a self-expanding guide tube structure, but it is envisioned that adding ICM to the manually expandable PTAC 100 of FIGS. 2 - 10 further supports and backs up the guide tube that points at the inner wall of the target vessel.

[0150] An important inventive feature of the PTAC 200 of the present application is the radial and transverse / circumferential support structures for the needle guiding element / guide tube 115 and guide tube 215 of FIGS. 4 and 12. There are a hollow shaft 120 having an opening 131, and a central support portion 121 for supporting the guide tube 1 15 in the radial and lateral directions, and an ICM 250 of FIG. 12 for supporting the guide tube 2 15 in the radial and lateral directions.

[0151] FIG. 15 is a longitudinal sectional view of a PTAC 300, which is another embodiment of the present application. The PTAC 300 includes a guide tube 316 and an injection tube 318 that are combined into a single injection tube assembly 315 having a distal radiopaque marker 322, a distal end 329 having a distal opening 31 7 and a distal injection needle 319, and a gold plating on the outer surface of the injection tube 318 to enhance the visibility of the needle 319 under fluoroscopy. The PTAC 300 has an outer tube 302 having a distal tapered protrusion 306 and an opening 331 through which the advancing injection tube assembly 315 passes. The PTAC 300 also has an inner tube 305 connected to an injection lumen 333. The injection lumen 333 is in fluid communication with the lumen of the injection tube / guide tube assembly 315, and the lumen of the injection tube / guide tube assembly 315 is in fluid communication with the lumen of the injection needle 319. The inner tube 305 is attached to the injection tube / guide tube assembly 315 via a connecting tube 325. Similar to the central support portion 121 of FIGS. 3 and 4, the central support portion 321 provides an inclination 344, and the inclination 344 bends the injection tube assembly 315 outward and supports the penetration of the target vessel wall by the injection needle 319 in the radial direction.

[0152] The central support portion 321 is similar to the central support portion 121 of FIGS. 3 and 4. The central support portion 321 provides an inclination 344, and the inclination 344 bends the injection tube assembly 315 outward and supports the penetration of the target vessel wall by the injection needle 319 in the radial direction. The distal protrusion 345 of the central support portion 321 is connected to the distal tapered protrusion 306. The outer tube

[0153] ​ The hub 302, distal tapered projection 306 or central support 121 may also contain a radiopaque marker, or may be made of a plastic containing a radiopaque filler such as tungsten-filled polyurethane. The central support 321 must extend proximally by a sufficient distance so that the needle distal opening 317 is fully retracted within the body of the PTAC 300 to avoid needle sticks by the user of the PTAC 300.

[0154] The distal tapered projection 306 is preferably made of a relatively low durometer hardness plastic or a flexible plastic. The injection needle 319 can be made of any metal that retains its shape, but is preferably made of a cobalt-chromium alloy such as L605 or a shape memory alloy such as nitinol.

[0155] It is contemplated that the PTAC 300 can have a distal fixed guide wire as in the PTAC 100 of FIG. 3, or can be delivered over a guide wire either in an over-the-wire or rapid exchange fashion. Similarly, the PTAC 100 of FIGS. 2-11 or the PTAC 200 of FIGS. 12-14 can use a flexible tapered projection similar to the tapered projection 306 of FIG. 15 instead of the fixed guide wire 211 shown as in other embodiments disclosed herein.

[0156] The PTAC 300 has the advantage of having one less step in needle delivery compared to the PTAC 100 of FIGS. 2-11. After positioning the distal end of the PTAC 300 at the desired site, the operator uses the mechanism at the proximal end of the PTAC 300 to 5 can be advanced relative to the outer tube 302. By doing so, the injection tube assembly 315 advances and bends outwardly when bent by the inclination 344 of the central support portion 321, exits the opening 331, and enters the outer tube 302. The needle 319 penetrates the inner wall of the target vessel and the penetration is restricted by the distal end of the injection tube / guide tube assembly 315. The combination of the distal radiopaque marker band 322 on the injection tube / guide tube assembly 315 and the gold plating on the needle 319 enables the operator to visualize the deployment of the PTAC 300 for delivering the ablation fluid into the perivascular space.

[0157] In this embodiment of the PTAC 300, the injection tube / guide tube assembly 31 5 expands outwardly and is a needle guiding element that supports / backs up the injection needle 319 as the injection needle 319 advances through the inner wall of the target vessel.

[0158] FIG. 16 is a longitudinal sectional view of the distal portion of yet another embodiment of the PTAC 400 disclosed herein, wherein in this embodiment, an inflatable balloon 450 is used that expands four guide tubes 415 outwardly to engage the inner wall of the target vessel. In this embodiment, three to eight guide tubes are envisioned, and three guide tubes are preferred for delivering ethanol for renal denervation.

[0159] The PTAC 400 has an outer layer 425, a guide wire 420 attached and fixed to the distal side, a core wire 411, and a distal tip 428. FIG. 16 shows its fully deployed position together with the guide tube 415 having the radiopaque marker 422. shows the PTAC 400 in the deployed position. Coaxial within the guide tube 415 are the injection tube 416, the distal injection needle 419 with a sharp tip, and the distal opening 417 disposed outside beyond the distal end 429 of the guide tube 415. The radiopaque wire 418 is within the lumen of the injection tube 416 for dead space reduction and increases visibility.

[0160] The distal portion of the PTAC 400 has a tapered portion 426, a radiopaque marker band 424, and a proximal portion 423. Including elements 423, 424, and 426, this tapered portion is referred to as the occlusion portion 430. The occlusion portion 430 is attached to a fixed guide wire 420 having a distal tip 428, an outer layer 425, and a core wire 411. Another important feature of this embodiment is the radiopaque marker band 413 on the sheath 402, and the radiopaque marker band 413 is such that when the PTAC 400 is in its contracted position and the sheath 402 is at its most distal position, as a result, whether the guide tube 415 and the injection tube 416 are fully contracted is easily visible to the operator. In conjunction with the radiopaque marker band 424 on the occlusion portion 430, it indicates the position of the distal end of the sheath 402 relative to the occlusion portion 430. When the injection tube 416 having the distal injection needle 419 advances and penetrates the inner wall of the target vessel, the pre-formed radius of curvature of the injection tube 416 should be similar to that of the guide tube 415 so that the guide tube 415 maintains its position relative to the inner wall of the target vessel. Specifically, the radius of curvature of the central axis of the distal portion of the injection tube 416 should be substantially the same as the radius of curvature of the central axis of the guide tube 415. The guide The radii of curvature of the central axes of the tube 415 and the injection tube 416 are each within 1 mm and should ideally be within 0.2 mm each. The curved shape with a single radius of curvature is shown in Fig. 16, but the curved shapes of the guide tube 415 and the injection tube 416 may each consist of two or more portions having different radii of curvature. Even if these portions have two or more radii of curvature, it is important that the curved shape of the injection tube 416 when fully deployed has its longitudinal axis coaxial with the longitudinal axis of the lumen of the curved portion of the guide tube 415. In other words, the advanced injection tube 4 16 must fit completely within the advanced guide tube 415. If the radii of curvature are significantly different, the radius of curvature of the injection tube 416 must be smaller than that of the guide tube 415, which is to prevent the injection tube 416 from pushing away from the inner wall of the target vessel when the injection tube 416 advances. These two radii of curvature characteristics must both be within 20% of each other and ideally within 5% of each other. Similar to the PTAC 100 of Figs. 2 - 11, the guide tube 415 is a needle guiding element that expands outwardly to support / backup the injection needle 419 at the distal end of the injection tube 416 as the injection tube 416 having the injection needle 419 passes through the inner wall of the target vessel.

[0161] Fig. 16 shows an inflatable balloon 450 attached to the inner tube 405 at its proximal end and to the occlusion portion 430 at its distal end. The side holes 452 in the inner tube 405

[0162] provides fluid communication between the inflated lumen 433 of the inner tube 405 and the internal space 454 of the inflatable balloon 450. As a result, compared to the case of the INAS 50 shown in FIG. 1 , the radial stability of the guide tube 415 is significantly improved. This is because the balloon 450 radially supports the guide tube 415 firmly. The outer side of the balloon 450 may be fixedly connected to each guide tube 415. In this configuration, the balloon 450 connected to the guide tube 415 uniformly expands the guide tube 415 and improves the central placement of the distal portion of the PTAC 400, thereby improving the lateral stability of the guide tube 415 . . .

[0163] The PTAC 400 and the guide tube 415 can advance and retreat in the same manner as in the above-described embodiment, or the PTAC 400 and the guide tube 415 may be connected to the inner tube 405, and only the injection tube 416 may be movable longitudinally within the lumen of the guide tube 415 . .

[0164] Similar to the above-described embodiment, the PTAC 400 can be configured to advance on a single guide wire or without any guide wire at all . Also, similar to the PTAC 300 in FIG. 15, the guide tube 415 and the injection tube 416 can be combined .

[0165] Regarding the configuration shown in FIG. 16, the sheath 402 having the distal radiopaque marker band 413 is retracted to allow the guide tube 415 to expand outward. The radiopaque wire 418 and the radiopaque marker bands 422, 424, and 413 . . may be made of any high-density metal such as gold, platinum, or tantalum, or an alloy of such metals. It may be made of a metal.

[0166] The balloon 450 may be flexible, semi-flexible, or non-flexible, but a flexible balloon with flexibility is preferred. This is because by changing the inflation pressure of such a balloon 450, the diameter of the expanded guide tube 415 can be easily set. By connecting the guide tube 415 to the outside of the balloon, compared to the case where the guide tube 415 is arranged inside the balloon, the structure becomes simpler. By doing so, it becomes possible to engage with the inner wall of the target blood vessel at the distal end 429 of the guide tube 415, and the entire balloon 450 does not contact the inner wall of the target blood vessel. When the balloon 450 contacts the inner wall of the target blood vessel, epithelial cells may peel off to some extent, and undesirable neointimal hyperplasia may occur. Usually, the balloon expands at an inflation pressure of 10 - 100 psi by injecting physiological saline through the inflation lumen 433.

[0167] FIG. 16 shows an inflatable balloon 450 that supports the guide tube 415 in the radial and lateral directions, but the use of any mechanical structure that can be inflated under the guide tube 415 is also envisioned. Such a structure may or may not be actually connected to the guide tube. For example, a structure similar to a car jack that is released when the ends match can also be used. A thread or simply a wire or tube that pulls the ends together can also form a structure that supports the guide tube 415.

[0168] An inflatable balloon such as the balloon 450 in FIG. 16 is placed in the central position within the lumen of the tube shown in FIG. 12 (I It is also contemplated to add to the PTAC 200 having the ICM 250. If the guide tube 215 having the ICM 250 has self-expandability or is manually inflatable, this is applicable.

[0169] Figure 17 is a schematic view of the central support portion 121 of the PTAC 100 of FIGS. 3 and 4. The distal tip 145 having the head portion 1 46 is connected to the proximal portion of the distal tip 106 of the PTAC 100 as shown in FIGS. 3 and 4. The curved inclined portion 144 supports radially and laterally when the guide tube 115 advances and moves outward along the curved inclined portion 144. The distal finger portion 1 42 has an inclined inner surface 148, and the inclined inner surface 148 also supports laterally when the guide tube 115 advances. The curved structure 142 (shown in FIG. 4) is connected to the inside of the outer tube extension portion 104.

[0170] Figure 18 shows a longitudinal section of three central portions of the PTAC 100 of FIGS. 2 to 11. At the proximal end of the central portion of the PTAC 100, there are three concentric metal hypodermic tubes, namely the outer hypodermic tube 82, the intermediate hypodermic tube 83, and the inner hypodermic tube 85. Usually, these are made of thin-walled metal tubes such as stainless steel, L605, cobalt-chromium alloy, or nitinol. The outer hypodermic tube 82 of the PTAC 100 has its distal end connected to the proximal plastic outer tube 92, and the outer tube 92 is generally made of a plastic having a relatively high durometer hardness, such as polyimide for example. As can be seen from the central cross-sectional view of FIG. 18, the proximal plastic outer tube 92 has its distal end connected to the proximal end of the outer tube 102 shown in FIGS. 2 to 11. Generally, the outer connected to the proximal end of the outer tube 102 shown in FIGS. 2 to 11. ​​​​​​​​ The tube 102 is made of a plastic that is lower in durometer hardness / more flexible than the proximal plastic tube 92.

[0171] As shown in the proximal portion of FIG. 18, the intermediate hypo tube 83 is connected at its distal end to the intermediate tube 103. As shown in the central portion of FIG. 18, the central infusion lumen 93 is connected at its distal

[0172] end to the proximal end of the inner tube 105 which has an infusion lumen 133 at its distal end. Similarly, shown in the distal portion of FIG. 18 is the connection tube 125 which connects the inner tube 105 to the infusion tube 116 of FIGS. 3 and 4 having the radiopaque wire 118, and the radiopaque wire 118 renders the entire length of the infusion tube 116 visible under fluoroscopy. The connection tube 125 is coaxial within the inner tube 105 at a portion proximate to the distal end of the inner tube 105. The proximal end

[0173] of the inner tube 105 is also coaxial within the outer tube 102, and the outer tube 102 is proximal to the outer tube extension 104 of FIGS. 2 - 10. FIG. 19 is a schematic view of the distal end of the fully expanded PTAC 100 of FIGS. 2 - 10, showing the direction of the sharpened infusion needle 119 relative to the distal end of the PTAC 100. FIG. 19 is a view of the PTAC 100 The opening surface of the needle 119 delivers the ablation liquid in a direction perpendicular to the longitudinal axis of the PTAC 100, and the inclined cutting surface of the needle 119 is cut so as to face laterally with respect to the axis of the needle 119.

[0174] When the needle 119 advances, the tip of the needle 119 is less likely to get caught inside the guide tube 115 due to which this configuration is beneficial. FIG. 20 shows a preferred triple cut needle 119 well, and the triple cut needle 119 further reduces the likelihood of getting caught inside the guide tube 115.

[0175] FIG. 20 is an enlarged schematic view of section S20 of FIG. 19, showing a preferred shape of the sharpened injection needle 119 ahead. FIG. 20 shows the direction of the liquid flow of the ablation liquid from the needle distal opening portion 117 perpendicular to the longitudinal axis of the PTAC 100. An additional cut 91 inside the needle tip 81 providing a sliding surface is also shown. The direction of the main cut of the needle 119, and further the direction of the additional cut 91 are combined to reduce the likelihood of accidentally getting caught inside the guide tube 115 when the needle 119 advances through the guide tube 115.

[0176] FIG. 21A is a schematic view of another embodiment which is the PTAC 500. The PTAC 50 0 uses the proximal portion of the occlusion 520 as a support structure for the guide tube 515. The occlusion 5 20 has a proximal portion 523, a radiopaque marker band 524, and a distal tapered portion 506 and the proximal portion 523 has a slot 525 in which the guide tube 515 is nested The outer tube 502 forms the outside of the PTAC 500 and functions as a sheath that advances over the proximal portion 523 of the occlusion 520 to form a sealed structure. The inner tube ​505 is the structure of the outer tube 502 that provides the driving force for the movement of the needle 519 (not shown). It is the inner tube. The wire 503 is a structure that provides the driving force for the movement of the guide tube 515. The core wire 511 is connected to the occlusion part 520, and the mechanism at the proximal end of the PTAC 50 0 facilitates the longitudinal movement of the occlusion part 520 with respect to the outer tube 502 and / or the guide tube 515. Although the PTAC 500 may be configured to be delivered over the guide wire, like the PTAC 300 in FIG. 15, its distal end may not have a guide wire. In this case, the fixed guide wire 509 is shown.

[0177] FIG. 21A shows the arrangement of the PTAC 500 where the guide tube 515 has advanced but the needle 519 is before advancing. The guide tube 515 can be manually advanced in the same manner as the PTAC 100 in FIGS. 2-11 or, like the prior art PTAC 50 in FIG. 1, the outer tube 502 functions as a sheath and is retracted to make the guide tube 515 self-expanding when it can be expanded outward. The next step after the arrangement in FIG. 21A is that the occlusion part 520 moves proximally (is retracted) by the proximal movement of the core wire 511 actuated by the mechanism within the proximal part of the PTAC 500. Thereby, the slot 525 enters the expanded guide tube 515 and moves proximally until it supports radially and laterally, similar to the central support part 1 21 shown in FIG. 17. When the occlusion part 520 is retracted, the needle 519 advances into the inner wall of the target blood vessel in the configuration shown in FIG. 21B.

[0178] ​​​​Figure 21B shows the placement of the PTAC 500 after the needle 519 has advanced into the inner wall of the target vessel at the distal end of the infusion tube 516. The occlusion portion 520 radially supports the guide tube 515 to prevent it from being pushed back from the inner wall of the vessel as the needle 519 advances. The slot 525 also laterally supports the guide tube 515 and the needle 519 such that they are positioned 120° from each other to uniformly inject the ablation fluid inside or outside the inner wall of the target vessel. As in the previous embodiment, the guide tube 515 is a needle guiding element. In this embodiment, the occlusion portion 520 is a vertically movable mechanism that radially and laterally supports the needle guiding element, which is the guide tube 515. Although this specification has focused on the use of PTACs in tissue ablation applications, it is expressly contemplated that the devices and methods of FIGS. 1 - 21B can be applied to the injection of any liquid for any purpose, including local drug delivery into many tissues within or immediately outside a particular portion of a blood vessel or into the prostate tissue via the prostatic urethra. While the embodiments shown in FIGS. 1 - 21B show three or four infusion needles, the structures disclosed herein that include a mechanism for radially and / or laterally supporting a needle guiding element that guides the needle as it penetrates the inner wall of the target vessel can be applied to designs having one needle, two needles, or five or more needles. Even in a single - needle design, it is smaller in diameter and easier to use than other single - needle systems such as the Bullfrog system from Mercatorr.

[0179] Although this specification has focused on the use of PTACs in tissue ablation applications, it is expressly contemplated that the devices and methods of FIGS. 1 - 21B can be applied to the injection of any liquid for any purpose, including local drug delivery into many tissues within or immediately outside a particular portion of a blood vessel or into the prostate tissue via the prostatic urethra. While the embodiments shown in FIGS. 1 - 21B show three or four infusion needles, the structures disclosed herein that include a mechanism for radially and / or laterally supporting a needle guiding element that guides the needle as it penetrates the inner wall of the target vessel can be applied to designs having one needle, two needles, or five or more needles. Even in a single - needle design, it is smaller in diameter and easier to use than other single - needle systems such as the Bullfrog system from Mercatorr. Although this specification has focused on the use of PTACs in tissue ablation applications, it is expressly contemplated that the devices and methods of FIGS. 1 - 21B can be applied to the injection of any liquid for any purpose, including local drug delivery into many tissues within or immediately outside a particular portion of a blood vessel or into the prostate tissue via the prostatic urethra. While the embodiments shown in FIGS. 1 - 21B show three or four infusion needles, the structures disclosed herein that include a mechanism for radially and / or laterally supporting a needle guiding element that guides the needle as it penetrates the inner wall of the target vessel can be applied to designs having one needle, two needles, or five or more needles. Even in a single - needle design, it is smaller in diameter and easier to use than other single - needle systems such as the Bullfrog system from Mercatorr.

[0180] While the embodiments shown in FIGS. 1 - 21B show three or four infusion needles, the structures disclosed herein that include a mechanism for radially and / or laterally supporting a needle guiding element that guides the needle as it penetrates the inner wall of the target vessel can be applied to designs having one needle, two needles, or five or more needles. Even in a single - needle design, it is smaller in diameter and easier to use than other single - needle systems such as the Bullfrog system from Mercatorr. The structures disclosed herein that include a mechanism for radially and / or laterally supporting a needle guiding element that guides the needle as it penetrates the inner wall of the target vessel can be applied to designs having one needle, two needles, or five or more needles. Even in a single - needle design, it is smaller in diameter and easier to use than other single - needle systems such as the Bullfrog system from Mercatorr. The structures disclosed herein that include a mechanism for radially and / or laterally supporting a needle guiding element that guides the needle as it penetrates the inner wall of the target vessel can be applied to designs having one needle, two needles, or five or more needles. Even in a single - needle design, it is smaller in diameter and easier to use than other single - needle systems such as the Bullfrog system from Mercatorr. The structures disclosed herein that include a mechanism for radially and / or laterally supporting a needle guiding element that guides the needle as it penetrates the inner wall of the target vessel can be applied to designs having one needle, two needles, or five or more needles. Even in a single - needle design, it is smaller in diameter and easier to use than other single - needle systems such as the Bullfrog system from Mercatorr. The structures disclosed herein that include a mechanism for radially and / or laterally supporting a needle guiding element that guides the needle as it penetrates the inner wall of the target vessel can be applied to designs having one needle, two needles, or five or more needles. Even in a single - needle design, it is smaller in diameter and easier to use than other single - needle systems such as the Bullfrog system from Mercatorr. .

[0181] Various other modifications, adaptations, and alternative designs based on the above teachings are, of course, possible. It is thus to be understood that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described herein. ​

Claims

1. A method for delivering a liquid via at least two injection needles into tissue outside the inner wall of a target vessel of a human body.

1. A catheter for use in a catheter comprising: a longitudinally extending central shaft and a fluid a catheter body having an infusion lumen; extending outwardly toward the inner wall of the target blood vessel; a) a mechanical support structure supporting said needle guiding elements; a) a mechanical support structure that supports the needle guide element laterally; and b) a mechanical support structure that supports the needle guide element laterally. a needle guide element extending in a direction selected from the group consisting of a lateral direction, a lateral direction, and a transverse direction. a mechanical support structure adapted to receive the fluid from the catheter body; and the needle has an injection lumen extending therethrough and is advanced outwardly and guided by the at least two needle guide elements. a catheter adapted to be guided into and penetrate the inner wall of the target vessel, the catheter being adapted to be guided into the outer wall of the target vessel; At least two infusion needles having distal openings for delivering fluid into the tissue.

2. 10. The catheter of claim 1, wherein the at least one needle guide element comprises a guide tube. That is, a catheter.

3. 2. The catheter of claim 1, wherein the mechanical support structure is a distal end of the catheter body. a central support located within the needle guide member, the central support also supporting outward extension of the needle guide element; The catheter is adapted to support the catheter.

4. 2. The catheter of claim 1, wherein the mechanical support structure is a a distal opening located within the distal portion through which the needle directing element advances during outward expansion; , catheter.

5. 2. The catheter of claim 1, wherein the mechanical support structure is attached to the needle guide element. A catheter that is an attached intraluminal central alignment mechanism.

6. 10. The catheter of claim 1, wherein the mechanical support structure comprises a longitudinally movable mechanism. A catheter provided by the structure.

7. 10. The catheter of claim 1, comprising at least three needle guide elements and at least three The catheter further includes two infusion tubes, each of which has a distal infusion needle at its distal end. Thetell.

8. 10. The catheter of claim 1, wherein the needle guide element is curved having a first radius of curvature. the injection needle has a curved distal portion having a second radius of curvature, the radius of curvature of the catheter and the second radius of curvature are preset within 25% of each other. Tell.

9. 10. The catheter of claim 1, further comprising a fixed distal guidewire. catheter.

10. 10. The catheter of claim 1, wherein the catheter has an infusion channel extending from a proximal end to a distal end. A catheter having a total internal volume or dead space up to 0.3 mL.

11. 2. The catheter of claim 1, further comprising: a) the injection needle; b) the needle guide element; and c) a front end. the catheter body; and d) one or more structures selected from the group of mechanical support structures. [0023] The marker further includes a radiopaque marker attached to or within a portion thereof. 。

12. 10. The catheter of claim 1, wherein the mechanical support structure is external to the needle guide element. A catheter that provides radial and lateral support during expansion.

13. 13. The catheter of claim 12, wherein the lateral support structure comprises: a) the catheter within a distal portion of the body during expansion of the needle guidance structure toward the inner wall of the target vessel. a hollow shaft having a distal opening through which the needle guiding element is advanced; c) an intraluminal central alignment mechanism mounted to the needle guide element, the intraluminal central alignment mechanism also radially supporting the needle guide element; The catheter is selected from the group of central support.

14. 2. The catheter of claim 1, further comprising: a catheter member disposed near a proximal end of the catheter; A special connector that is different from any other connector on the catheter handle. The catheter further comprises an injection port.

15. 15. The catheter of claim 14, further comprising a catheter member located at or near the proximal end of the catheter. The catheter further includes a specially designed syringe having a distal end that mates with a specially designed connector for connecting the catheter to the catheter. Tell me.

16. A method for delivering a liquid via at least one injection needle into tissue outside the inner wall of a target vessel of a human body.

1. A catheter comprising: a catheter body having a longitudinally extending central axis and a fluid infusion lumen; at least one adapted to extend outwardly against the inner wall of the target vessel; Needle guidance element; The at least one needle guide element is supported as it extends outwardly toward the inner wall of the target vessel. at least one lateral support structure adapted to support the The catheter body has an infusion lumen in fluid communication with the fluid infusion lumen of the catheter body, and is adapted to be advanced outwardly. and being guided by the at least one needle guide element to penetrate the inner wall of the target vessel. and having a distal opening for delivering liquid to or near its distal end. At most one injection needle.

17. 17. The catheter of claim 16, wherein the at least one needle guide element is a guide tube. A catheter.

18. 17. The catheter of claim 16, wherein the lateral support structure is disposed on the catheter body. and a needle guide member for guiding the needle to the inner wall of the target vessel. The catheter is a hollow shaft having a distal opening through which the catheter advances and expands.

19. 17. The catheter of claim 16, wherein the at least one lateral support structure comprises a A catheter that is an intraluminal central alignment mechanism attached to a needle guidance element.

20. 17. The catheter of claim 16, wherein the needle guide is directed toward the inner wall of the target vessel. At least one radial support adapted to support the expansion of each of the guide elements. The catheter further includes a retaining structure.

21. 10. The catheter of claim 1, wherein the mechanical support structure is selected from the group consisting of: a) at least two needle guide elements located within a distal portion of the catheter body; a) a central support portion adapted to support the outward expansion of the at least two a) an intraluminal central alignment mechanism attached to the needle guide element; c) an inflatable balloon; and d) a ) an occlusion portion that moves proximally to engage and support the at least two needle guiding elements.

22. 17. The catheter of claim 16, further comprising a specially designed The catheter further includes a fluid injection port which is a connector for the catheter.

23. 23. The catheter of claim 22, further comprising a special feature located at the proximal end of the catheter. The catheter further includes a specially designed syringe having a distal end that mates with the connector.

24. 17. The catheter of claim 16, further comprising at least three needle directing elements. catheter.

25. 17. The catheter of claim 16, wherein the total internal volume or dead space within the entire catheter is 0.3 A catheter that is less than mL.

26. 17. The catheter of claim 16, comprising: a) the infusion needle; b) the needle guide element; c) the catheter body; and d) the lateral support structure. or a portion thereof.

27. 2. The catheter of claim 1, wherein the at least two needle guide elements are adapted to move and move outward. The catheter further includes a control mechanism adapted to control the lateral expansion.

28. 2. The catheter of claim 1, wherein the at least two infusion needles are adapted to move and move outward. the catheter further comprising an injection needle control mechanism adapted to control the expansion of the catheter.

29. 1. A method for cauterizing tissue located radially outward from an interior surface of a vessel of a human body, comprising: The method includes steps: a) a plurality of outwardly extending needles having a proximal end and a distal end and adapted to pass and advance a plurality of infusion needles therethrough; The needle guide element and the injection needle are located at a distal portion thereof. The distal portion also includes a mechanical support mechanism that supports the outwardly expandable needle guide element. manufacturing a woven ablation catheter; b) positioning the distal end of the tissue ablation catheter in advance of a site within a vessel of the body where tissue ablation is to be performed; To advance; c) advancing a plurality of needle directing elements supported by another support structure to guide the needle into the target vessel; The catheter is then expanded outwardly against the wall, thereby centering the distal portion of the catheter in the target vessel. to place; d) advancing a plurality of infusion needles into the vessel wall through the plurality of needle guide elements; e) injecting cauterizing fluid into and / or outside the adventitia of the target vessel through the plurality of injection needles. thing.

30. 30. The method of claim 29, wherein the needle guide element passes through an opening in a side of the catheter. and advancing through said opening, said opening forming at least a portion of said additional support structure.

31. The catheter of claim 1 , wherein the target vessel is a renal artery.

32. The catheter of claim 1 , wherein the target vessel is the urethra.

33. 30. The method of claim 29, wherein the vessel of the body is a renal artery.

34. 34. The method of claim 33, wherein the ablation is for achieving renal denervation for the treatment of hypertension. The method wherein the fluid is injected into an area between 2 mm and 8 mm from the inner surface of the renal artery.

35. 34. The method of claim 33, wherein the cauterizing fluid is selected from the group consisting of: How to do it: a) ethanol, b) phenol, c) glycerol, d) a heated liquid, and e) Extremely chilled liquids such as liquid nitrogen.

36. 34. The method of claim 33, further comprising administering a topical injection of cauterizing fluid prior to or during the injection of cauterizing fluid. A local anesthetic is injected across the interior wall of the renal artery.

37. 30. The method of claim 29, wherein the vessel of the body is the urethra.

38. 38. The method of claim 37, wherein the cauterizing solution is administered to a male subject as a treatment for benign prostatic hyperplasia. Methods are designed to ablate prostate tissue.

39. 38. The method of claim 37, wherein the cauterizing fluid is administered to the male prostate as a treatment for prostate cancer. A method is designed to cauterize glandular tissue.

40. 30. The method of claim 29, further comprising: When the needle guide element is expanded relative to the target vessel, the The method of claim 1, wherein the distal portion of the catheter is centered within the vessel.

41. 10. The catheter of claim 1, wherein the at least one injection needle is a square needle. Thetell.

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