Perivascular tissue ablation catheter with support structure - Patents.com

Abstract

To provide an instrument ablating tissues and nerve fibers.SOLUTION: An intravascular catheter for peri-vascular and / or peri-urethral tissue ablation includes supported guide tubes and multiple needles advanced through the supported guide tubes which expand with open ends around a central axis to engage an interior surface of the wall of the renal artery or other vessels of a human body allowing the injection of ablative fluid for ablating tissues, and / or nerve fibers in an outer layer or deep to the outer layer of the vessel, or in a 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 for the guide tubes so that the guide tubes open uniformly and maintain their positions 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 to denervate sympathetic nerves from within the renal artery for the treatment of blood pressure or CHF There are potential risks associated with using RF energy to deliver RF energy to the renal artery wall from inside the renal artery. The short-term and long-term complications of applying the renal artery are not fully understood. This type of energy application within the renal artery and transmural injury has been associated with delayed restenosis, thrombus formation, and renal artery dysfunction. This may cause pulse spasms, embolism of debris into the renal parenchyma, or other problems within the renal artery. In particular, there may be anatomical abnormalities within the renal artery, or atherosclerosis or fibrosis. If this is the case, RF energy will not be delivered uniformly, resulting in uneven or incomplete sympathetic nerve ablation. This may lead to treatment failure or to widespread involvement of the adventitial surface of the renal artery. This may require cauterization of the sympathetic nerves with even more dangerous levels of RF energy. Similar problems can arise with the use of ultrasound.

[0005] Simplicity for RF Energy Delivery TM In the system, the sympathetic fibers of the kidney It is also not possible to effectively ablate the circumferential area of ​​the renal artery. (energy is applied to the intimal surface to destroy the sympathetic nerves outside the adventitial layer) If we assume that the renal artery is stenotic, we can conclude that the renal artery is stenotic due to circumferential and transmural thermal damage to the intima, media, and adventitia. Finally, there is a higher risk of developing endovascular treatment of the renal artery using RF energy. The "cauterization" of the wall is likely to be accompanied by severe pain. RF ablation renal denervation takes a long time, Sedatives are required to control the intense pain caused by repeated cauterization of the vessel walls. Sometimes, very high doses of morphine or other opiates and near general anesthesia are required. Therefore, there are many practical limitations to the current approach of RF-based renal sympathetic denervation. Ultrasound or other energy delivery techniques have similar limitations.

[0006] Sew uses an inflatable elastic balloon to expand a single needle toward the inside wall of a blood vessel. Nos. 6,547,803 and 7,666,163 to A. D. ard et al. The Bullfrog® Micro Injection Catheter is designed to be chemically resistant to alcohol and other substances. It could be used to inject cauterizing fluid, something that these patents do not describe or anticipate. However, multiple applications were required for circumferential delivery of the cauterizing material around the entire circumference of the vessel. The maximum number of needles shown by Edward et al. is two, and the two-needle version of Bullfrog (registered The new endothelial catheter is designed to be small enough to fit into the small guide catheters used in the renal arteries. When using only one needle, it was difficult to insert all the devices at the end of the catheter. It is obviously difficult to control and precisely rotate the nozzle, and subsequent injections are not uniform. This device allows precise control of the delivery depth of the nerve cauterizing agent. The device also lacks the ability to precisely control and adjust the length of the needle that can be used. There are also physical constraints, so it is necessary to apply the cauterizing agent to a suitable depth, especially in areas with thickened intimal tissue and disease. The ability to inject into the renal artery is limited by certain disease conditions. The limitation is that when the balloon is inflated in the renal artery, the balloon damages the intima and media of the renal artery, Furthermore, it induces endothelial cell detachment, which leads to temporary renal ischemia and delayed vascular The problem is that it may cause stenosis.

[0007] Jacobson and Davis, in U.S. Pat. No. 6,302,870, The Jacobson et al. patent describes a catheter for injection into the inner wall of a blood vessel. The concept is to provide a plurality of outwardly extending needles, each having a shaft that limits the penetration of the needle into the vessel wall. It is a tube with a needle at its distal end that rotates and curves outward. The design is based on the idea that the needle tip is attached close to the distal end of the needle at a short distance. The small disk-shaped handle is attached, but its diameter is constant, so the diameter of the handle The total diameter of the device is increased by at least two times, and the diameter of the shaft is large enough to prevent needle penetration. If the diameter of the tube is large enough, the diameter of the device will increase significantly. By using a handle with a diameter, the device becomes larger and the needle is inserted inside the hollow shaft from which the needle emerges. The needle cannot be fully retracted, so it remains protruding from the hollow shaft, which can lead to an accidental needle stick. Whether applied to renal denervation or atrial fibrillation, the needle catheter Such rotation is difficult due to the long length of the needle. Also, the shank, which limits penetration, is located at the distal end of the needle. If you want to selectively target a specific layer in a vessel, or Even though the catheter must penetrate significantly beyond the adventitia of the vessel in vessels with different wall thicknesses, The penetration depth cannot be adjusted in situ. Finally, Figure 3 of the Jacobson et al. patent does not contemplate the use of a gaffer for denervation. 1 shows a sheath covering an expandable needle without an guidewire and having an open distal end. The sheath makes advancement through the vascular system more difficult. Also, the shank makes it difficult to When the needle is fully retracted into the sheath, it may become clogged inside the sheath, making it difficult to push out. There is a gender.

[0008] As early as 1980, Kline et al. reported "Functional reinnervation after renal denervation in rats." (American Phys. iological Society1980:0363-6110 / 80 / 0000- As published in the 2008 IEEE International Conference on Computer Vision (ICCV), Alcohol has been shown to be effective in renal denervation in animal models. Kline et al. "95% alcohol was applied to the vessel to destroy all remaining nerve fibers. By using this technique for renal denervation, we were able to demonstrate that renal norepinephrine was eliminated within 2 weeks of surgery. We found that pinephrine concentrations were depleted by more than 50% (i.e., <10 mg / g tissue). " In 1983, he also wrote in his paper "Kinematics of Renal Denervation in Aortic Denervated Rats" Effects on Pulse Pressure" (Hypertension, 1983, 5:468-475) In a study, Kline et al. again demonstrated that a 95% alcohol solution applied during surgery reduced the Since the 1990s, several The method described by Jacobson et al. was designed to inject fluid into the arterial wall at a single point. Such drug delivery catheters have been constructed.

[0009] McGuckin, in U.S. Pat. No. 7,087,040, describes a method for dispensing liquid from a single needle. This paper describes a tumor tissue ablation catheter with three expandable prongs for injecting The teeth expand outward to 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. into tissue within the human body with the intent to damage, destroy, or cauterize nerves or tissue within that tissue It is used interchangeably to include either liquid or gaseous substances being delivered.

[0012] Also, throughout this specification, the term "inner wall" refers to a blood vessel, vascular wall, artery, or arterial wall. The term surface means the same thing, the inner surface of the vessel wall, inside of which is the vessel lumen. The term injection outlet is defined as the distal opening in the needle through which the injected fluid exits. With respect to an injection needle, either the injection outlet or the distal opening are used herein with the same meaning. Used in.

[0013] The term "deep" of a structure refers to the many structures that lie outside the adventitia of arteries that have an "adventitia deep" part. is defined as beyond or outside of that structure, representing the organization of Summary of the Invention [Problem to be solved by the invention]

[0014] Fischell et al., U.S. Patent Application Serial Nos. 13 / 216,495 and 13 / 294 In Nos. 13 / 342,521 and 13 / 342,439, the cauterizing fluid was injected into or into the inner wall of the target vessel. describes several methods using expandable needles for deep delivery. The entire contents of these applications are incorporated by reference as part of the specification. Application No. 13 / 2 Embodiments of Nos. 16,495, 13 / 294,439, and 13 / 342,521 There are two types of needles: those in which the needles extend outward without support from any other structure. and a guide tube that functions as a guiding element to support the needle as it advances into the inner wall of the target vessel. The limitations of the needle-only design are small enough to avoid bleeding after vascular penetration. If a needle is used, such a needle may require a large diameter to be inserted into the desired location in a reliable and uniform manner. In one embodiment, the needles may be too fragile. The use of strings or wires for this purpose has been of some help in this area. Fischell et al. The guides described in application Ser. Nos. 13 / 294,439 and 13 / 342,521 are incorporated herein by reference. The use of guide tubes greatly improves this support, but the use of unsupported guide tubes The ability to uniformly expand the tube and center it appropriately in the distal portion of the catheter is crucial. The catheter cannot be centered predictably, and the guide tube itself is dependent on its shape. Without tube expansion, accurate and reproducible needle penetration to the target depth is difficult. , it becomes difficult.

[0015] Another limitation of unsupported guide tubes is that as the infusion needle advances through the guide tube, There is no radial support or "back-up" as the needle advances. In other words, the guide tube may be pushed away from the inner surface of the vessel wall. If the catheter is made stiff enough to back up the catheter, the distal part of the catheter will be more rigid. This can limit the catheter's ability to be delivered and can cause trauma to the inner wall of the target vessel. If the guide tube is sufficiently flexible, it may become distorted during advancement of the injection needle. , may be dislodged from the inner surface of the vessel wall and / or may be radially displaced, resulting in injection The sites may not be symmetrically positioned about the central axis of the target vessel. [Means for solving the problem]

[0016] The present application relates to a perivascular tissue ablation catheter (PTAC) for use within the outer layer or outer layer of a vessel in the human body. PTA capable of delivering cautery fluid to circumferentially damage tissue beyond the outer layer C. Ablation of tissue and nerves using this technique is more efficient than with RF ablation catheters. It can be completed in a relatively short time, and it uses only a disposable catheter, making it easy to use. It has the advantage that it does not require external capital equipment. It is possible to use short-acting anesthetics such as ersed, which reduces the dose of anesthetic and improves treatment. This reduces or eliminates the discomfort and pain experienced by patients during treatment.

[0017] The main targets for using PTAC are the treatment of hypertension and congestive heart failure by renal denervation, and Treatment of BPH and prostate cancer by ablation of prostate tissue via an intraurethral catheter.

[0018] Bullfrog injection catheters and current Unlike the RF ablation devices disclosed herein, the devices disclosed herein do not inject fluid around the vessel. It is designed to penetrate the vascular lining while minimizing damage to nerves or other "target" tissue. It is possible to more uniformly damage the tissue circumferentially. The term refers to the simultaneous injection of a suitable cauterizing solution at at least three points within a vessel wall. It is defined as a circumferential injection into the space outside the adventitial layer (outer layer) of a blood vessel. No. 6,302,870, does not describe circumferential delivery. Unlike a vice, the devices disclosed herein have a tube that produces an outward movement. It does not rely on a rotating burr nor does it have a constant diameter shaft to limit penetration. Moreover, the Jacobson et al. patent describes a version of the catheter that retracts into a tubular sheath. The device shows a tube having one open end, The claims of the patent allege that a fluid flowing through a single lumen is directed from the distal end of a catheter through multiple needles. It may be necessary to increase the diameter to accommodate the connecting tube that allows the outlet to exit through the In the preferred embodiment of the present application, the connecting tube used fits within the lumen of the tube. This significantly reduces the diameter of the catheter, allowing it to be delivered to the desired location within the body. It has become easier to do so.

[0019] Specifically, the sympathetic nerves around the renal artery or the tissue around the target vessel can be reproduced with high efficiency. A catheter system capable of ablation to improve hypertension and other management and treatments is provided. The most significant improvement of the present disclosure is that the method of the present invention is directed to the method of the present invention. Guide tubes as described in Nos. 13 / 294,439 and 13 / 342,521 The support structure has been added to improve the uniformity and symmetry of the expansion. The structure includes a guide tube that is expanded as the needle advances through the guide tube and into the inner wall of the target vessel. This provides radial (outward) support for the tube for better backup.

[0020] This type of system is located near or within the wall of the pulmonary vein ostium into the left atrium of the heart. To enable highly efficient and reproducible circumferential cauterization of muscle fibers and conducting tissue. This has a major advantage over other current techniques. Using the concept of this application, it has been possible to terminate AF and other cardiac arrhythmias. To treat benign prostatic hyperplasia (BPH) or prostate cancer by cauterizing prostate tissue outside the prostate gland. Other possible applications of this technique may become apparent from the various teachings herein. do.

[0021] Similar to the previously mentioned application of Fischell et al. for the treatment of hypertension, the present application relates to a small diameter A catheter having a plurality of dilating catheters each having a sharp injection needle at or near its distal end. and a needle for injecting the needle into and through the inner layer of the target vessel. A small diameter catheter is advanced through a guide tube designed to support and guide the passage of the catheter. Fisch in U.S. Patent Application Serial No. 13 / 294,439 discloses The basic embodiment of the present invention, which is an improvement over the design of Ell et al., is of two types. In the first embodiment, Three or more manually expandable guide tubes are advanced through a hollow shaft within the distal portion of the PTAC. Each hollow shaft has a central shaft that curves outward from the longitudinal axis of the distal portion of the PTAC. The guide tube has a preformed curved portion that follows the hollow shaft. It advances outward toward the inner surface of the target vessel. The key to this design is the support provided by the central support. As the injection tube with the backup and distal needle advances through the vessel wall, a central catheter body that prevents the guide tube from being dislodged from the inner wall of the target vessel; Specifically, the central support part, which is part of the distal part of the hollow shaft, is curved outward. In addition to providing radial support to the guide tube, The central support, together with the openings in the distal end of the hollow shaft, are spaced apart so that the guide tubes are evenly spaced apart. It also supports the support of the vehicle in the forward and lateral direction.

[0022] Uniformity and predictability of device centralization and guidance into position of engagement with the inner wall of the target vessel. The present application also provides an improved control of the forward speed when advancing the guide tube. This application is significantly superior to application Ser. No. 13 / 294,439 filed by ISBN 97 / 113 / 294,439.

[0023] The distal portion of the guide catheter used to access the target vessel (such as the renal artery) is typically The three guide tubes are not aligned with the longitudinal axis of the target vessel and are therefore manually expanded. The devices disclosed herein, including embodiments that employ It will be advantageous.

[0024] As these three guide tubes advance outward, first one contacts the inner wall of the target vessel. As the guide tubes move further outwards, the first guide tube makes contact with the second Move the body of the PTAC along the inner wall of the target vessel until the guide tube of the eye contacts the inner wall of the target vessel. The two guide tubes are then pushed away from the third tube and into the center of the target vessel. Insert the body of the PTAC into the center of the target vessel until the guide tube touches the inner wall of the target vessel. The guide tubes herein are not fragile self-expanding structures, but rather Since they have the same expansion diameter around the longitudinal axis of the PTAC, the distal part of the PTAC The distal portion of the guide tube is then reproducibly positioned near the true center of the target vessel. Fluoroscopic images of the radiopaque markers above confirm correct centering of the guide tube. Correct centralization of the guide tube is confirmed after the guide tube is deployed. In addition, it can also be confirmed by injecting a contrast agent through the guide catheter.

[0025] Another important advantage of this system is that the injection tube with the distal injection needle penetrates the target vessel wall. Stability and "back-up" support for the guide tube when deploying / advancing the Once the guide tube engages the inner wall of the target vessel, it is supported by a hollow shaft within the PTAC body. This "back-up" central catheter prevents the injection needle from penetrating the inner wall of the target vessel. The guide tube remains stationary as it is inserted and advanced distally to the pre-set penetration depth. Cautery fluid is then delivered and the injection needle is retracted into the guide tube. The guide tube and injection needle are then retracted into the hollow shaft within the distal portion of the PTAC.

[0026] Application Ser. No. 13 / 294,439 to Fischell et al. uses a self-expanding design. In a second embodiment of the present invention, which improves upon the teachings of the above publication, an intraluminal centrally located mechanism (ICM) is provided. One embodiment of the ICM is a guide tube attached to the inner wall of the target vessel. and the guide tube is deployed toward the target vessel wall as the injection needle advances through the target vessel wall. Centering, uniformity and alignment of the guide tube to prevent it from being pushed away from the inner wall of the vessel Expandable wire cage for symmetrical expansion and improved radial support (backup) When the guide tube with the centrally located ICM is self-expanding, The ICM is particularly useful. The ICM can be manually expanded as described in the first embodiment above. The ICM can also provide additional stability and backup for the guide tube that can be used with IC Specific radiopaque markers that allow visualization of the M expansion status under fluoroscopy The ICM may include a guide tube for incising the inner wall of the target vessel. To reduce trauma to the layer, the distance from the tip of the guide tube to the inner wall of the target vessel is minimized. It can also be made to a certain extent.

[0027] At or near the distal end of any of the embodiments of the PTAC disclosed herein Cautery fluid can be injected through the distal end of an injection needle having a distal opening (injection port) at The injection needle is adjusted so that it penetrates a pre-determined distance into or beyond the inner wall of the target vessel. A preferred embodiment of the penetration limiting mechanism is as follows: The embodiment is incorporated within the proximal portion of the PTAC and can include a penetration depth adjustment means. The adjustment means may also include markings that allow for precise adjustment of the penetration depth.

[0028] Adjustment of the penetration depth by a mechanism in the proximal end of the PTAC can be controlled by the physician or by device manufacturer. In the previous example, intraluminal ultrasound or other imaging techniques could be used to In order to identify the thickness of the renal artery at the desired site for performing perivascular renal denervation (PVRD), The clinician then adjusts the penetration depth appropriately. The penetration depth adjustment method allows the PTAC to be pre-set at the factory, and multiple penetration depths are required. It is also envisaged that it may be offered in different product codes to allow for changes in penetration depth if required. For example, three penetration depths are available: 2 mm or more, 3 mm or more, and 4 mm or more. Other advantages of factory adjustment of the penetration depth are that it simplifies calibration and allows for When PTAC is varied, it is finally adjusted at the factory to have a precise penetration depth. The goal is to provide a high-quality product by meeting one or more pre-defined goals during a clinical trial. A document requesting approval to use penetration depth to reduce potential errors in setting the wrong penetration depth. Another advantage is that the factory-manufactured and calibrated It is also conceivable to incorporate both internal adjustment by means of a penetration depth marking and external adjustment by means of a penetration depth marking into the PTAC. It is determined.

[0029] With respect to the PTAC disclosed herein, the adjustment means is one of the following: 1. Adjustment and calibration of preset penetration depth during device fabrication. In this case, the product is labeled as having several calibrated penetration depths. Adjustment of the penetration depth by the device operator before or during use of the AC. This method includes This involves the use of markings on the PTAC to indicate the depth to which the cautery fluid is to be injected. A range of different penetration depths is desirable to allow delivery of appropriate amounts into the prostate tissue. It is particularly useful for the treatment of BPH and prostate cancer.

[0030] Ideally, the injection needle should be designed so that there is essentially no blood loss after the injection tube is detached from the vessel wall. The embodiment of the present disclosure is based on the method of Fischell et al. No. 13 / 216,495 and U.S. Pat. No. 6,302,302, to Jacobson et al. A significant advantage over the embodiments taught in the '870 patent is that the guide tubes disclosed herein are Self-expanding, even with small (<25 gauge) injection needles, due to the support of the flexible structure The structure is not fragile and can reliably penetrate the vascular wall. The guide tube with the CM attached was fabricated as described in U.S. Patent Application No. 13 of Fischell et al. The unsupported guides in Nos. 13 / 294,439 and 13 / 342,521 Another advantage is that the guide tube can be securely centered within the vessel. The ability to deploy the device and reduce trauma when the expanded mechanism contacts the inside of the vessel wall be.

[0031] The ICM supported guide tubes disclosed herein include several different There are several different embodiments, including: 1. Proximal, middle The catheter is made of a single tube or metal spring made of a shape memory alloy such as Nitinol having a core and a distal portion. An expandable structure comprising a ring, the proximal portion of which is connected to an injection port having a distal injection needle. Fischell et al., U.S. Patent Application Serial No. 13 / 294,439, which guides the intubation tube and guide tubes similar to those in 13 / 342,521. The central and distal parts are ICMs. The central part of this structure has a radiopaque marker. The structure has a tubular shape and expands to contact the interior wall of the vessel in a minimally traumatic manner. The expandable distal section supports the guide tube and the central portion of the expandable structure to provide a reproducible In a preferred embodiment of this structure, the distal portion is highly flexible. The structures herein can be self-expanding or can be provided at the proximal end of the PTAC. The IC can be expanded through the operation of the Expansion Control Mechanism (ECM) that is provided by the PTAC, or the IC can be self-expanding. It can be both, if it has M and ECM that can be used to regulate or promote expansion. 2. A prosthesis having a proximal portion, a central portion, and a distal portion, and having an embedded spring member. The spring member extends from the distal end of the guide tube. The expandable structure extends distally from the endothelium to form the ICM. Guide to US Patent Application Nos. 13 / 294,439 and 13 / 342,521 A guide tube, similar to a needle, guides an injection tube having a distal injection needle. The core of the body has radiopaque markers and is dilated and pulsed to minimize trauma. The expandable distal portion of the structure contacts the inner wall of the canal. The center of the structure is supported to facilitate reproducible expansion. The structures herein are self-expanding. or by manipulating the expansion control mechanism (ECM) at the proximal end of the PTAC. Alternatively, PTAC can be used to adjust or facilitate self-expanding ICMs. If the cell has an ECM that supports the cell, it can be both. Guide to US Patent Application Nos. 13 / 294,439 and 13 / 342,521 An expandable guide tube, similar to a catheter, that guides an injection tube having a distal injection needle. The guide tube is attached to the ICM and is formed by an inflatable balloon. The balloon is inflated through a lumen within the hollow shaft of the PTAC.

[0032] Typically, the injection tube with the distal injection needle of the embodiments disclosed herein is a guide tube. The tubing has a preset curved shape with a radius of curvature similar to that of the tube. Thus, as it advances through the guide tube, the injection tube It follows the curve and does not change the position of the guide tube relative to the inner wall of the target vessel. The difference in the radius of curvature of the distal portion of the guide tube and the infusion tube should be within ±25%. Ideally, this should be within ±10%.

[0033] After the guide tube is expanded, the device can be used without being restricted by the inner wall of the vessel. The diameter of the vessel is set to be slightly larger than the maximum diameter of the vessel. The embodiment is useful in vessels having different diameters. As it extends from the distal end of the tube and penetrates through the vessel wall, it may also curve proximally backward. This is one of the characteristics of the embodiment of the present application.

[0034] The penetration depth should be precise, either at the proximal or distal part of the PTAC. The tubing used is designed to not stretch during deployment through the guide catheter and into the renal artery. For example, stainless steel L605 or Nitinol hypotubes are the best material for the proximal lumen of the PTAC. Use a metal reinforced tube or a plastic with low stretchability and high durometer hardness. Such a tube can be used to guide the distal portion of the PTAC from the aorta into the renal artery. Needs more flexibility to navigate near-right angle bends within guide catheters Therefore, it is also suitable for the distal part of the PTAC.

[0035] An infusion tube having a distal infusion needle is in fluid communication with an infusion lumen within the catheter body. An infusion lumen within the catheter body is in fluid communication with an infusion port at the proximal end of the PTAC. Typically, such injection ports include a Luer connector or similar connector that is used to connect to a source of cauterizing fluid. Also included herein is a standard connector for dispensing cautery fluid from a standard syringe. Improved safety by making accidental injection impossible and allowing for cauterizing agent injection A special (proximal) fitting for the injection port (Lue) was used to minimize dead space within the catheter. The description assumes the use of a connector (different from the connector).

[0036] The injection system may be used to inject blood into the aorta, pulmonary vein, or renal artery, or into the adventitial layer or lining of the prostatic urinary tract. The needle penetrates the arterial wall so that it is safe to penetrate deep into many tissues. The use of very small gauge needles (less than 25 gauge) is also contemplated. or round needle, and if a square needle is used, the injection outlet / distal opening is It may be a small outlet (hole) on the proximal side of the tip of the needle, either in the tube or in the distal needle. There must be at least two infusion tubes, but the treatment subject must be Depending on the diameter of the vessel and the diffusion capacity of the injected cauterizing fluid in the perivascular space, three types of However, in some cases, a larger infusion tube may be more appropriate. For example, a renal artery with a diameter of 5 mm may be used. In this case, three or four infusion tubes are required, while the renal artery diameter is 8 mm. In this case, five or six infusion tubes are required.

[0037] In a preferred embodiment of the present disclosure, ethanol is hydrophilic and lipid soluble and is effective in the perivascular space. It is used as a cautery fluid because it diffuses rapidly in the bloodstream. Only three needles are needed, allowing the diameter of the device to be small. When ethanol or other alcohol is added to the agent, the cauterizing agent is absorbed into the perivascular space. It is also expected that the spread of

[0038] Generally, the self-expanding PTAC embodiments disclosed herein include the treatment of a single renal artery. During the transition from one renal artery to another and during removal from the body, the guide It includes a hollow, thin-walled sheath that houses the tubing and the ICM. This sheath is It also allows for easy insertion of the distal end of the catheter C into a guide catheter or introducer sheath. The sheath enables the practitioner to remove the PTAC from the patient's body at the end of the treatment procedure. The sheath also provides protection against potentially harmful needlestick injuries and blood-borne pathogens. A radiopaque sheath that is placed near the distal end of the sheath to inform the practitioner of its location under fluoroscopy. Transient markers are included.

[0039] The entire PTAC can be configured to include a fixed distal guidewire or to be The lumen of the PTAC extends the entire length of the over-the-wire configuration or guidewire. The catheter body must extend at least 10 cm proximal to the distal end of the PTAC. The proximal portion of the guidewire extends outside the catheter shaft in a rapid exchange configuration. In some applications, the catheter is designed to be advanced over a guidewire. In the future, it is also envisioned that a flexible, tapered distal tip may be used without a distal guidewire. is.

[0040] Fixed guidewire version or flexible and distal guidewire-free version The version with the thin distal tip is the preferred embodiment since it provides the smallest distal diameter. Only the proximal side to the fixed guidewire is the distal end of the PTAC, called the occlusion. The occlusion segment serves the following purposes in the design of the PTAC: 1. The occlusion site is the site where the PTAC enters the renal artery through a small hole from the aorta in the guide catheter. The small diameter, fixed distal guide allows for convenient navigation around bends such as those encountered during surgery. It is a tapered, flexible member that increases in diameter from the guide wire. 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 may be equipped with two or more extendable legs.

[0044] In order to optimize the permanent disruption of the sympathetic nerves in a portion of the renal artery (neurotomy), The device is also capable of injecting one or more nerve ablation substances simultaneously or sequentially. Possible neurotoxic substances that can be used include ethanol, phenol, and glycol. Serol, a relatively high concentration of local anesthetic (e.g., lidocaine, bupivacaine, tetracycline, Other drugs such as benzocaine, benzocaine, etc.), neurotoxic antiarrhythmic drugs, botulinum toxin , digoxin or other cardiac glycosides, guanethidine, heated saline These include liquids, hypertonic saline, hypotonic liquids, KCl, or heated neurotoxic substances. These include, but are not limited to:

[0045] The cauterizing agent is either a hypertonic liquid such as hypertonic saline (high salt content) or a hypotonic liquid such as distilled water. It is conceivable that these drugs could cause permanent nerve damage and lead to alopecia. These drugs can work just as well as cholera or certain neurotoxins. can be injected at room temperature. Distilled water, hypotonic saline, or hypertonic saline can be used in the injection volume. Using less than 1 mL eliminates one step in the PTAC use procedure. Small amounts of these fluids are not harmful to the kidneys, so they can be removed during catheter removal. The cautery fluid was completely flushed with saline from the PTAC to prevent the fluid from entering the renal artery. This eliminates the need for cauterizing fluids that are more toxic. The conventional method requires two liquid injections per artery, whereas the use of distilled water etc. requires only one. This can be achieved by simply injecting liquid.

[0046] The PTAC is adapted to deliver hot liquid to cauterize or damage targeted tissue or nerves. It is also envisioned that the catheter may be connected to a source of heated liquid or vapor thereof. The fluids used may be saline, hypertonic fluid, hypotonic fluid, alcohol, phenol, lidocaine, or The needle injection site and the surrounding target tissue or nerve Heated or vaporized saline, hypertonic saline, or hypotonic saline for thermal cauterization of the nerves Saline, ethanol, distilled water, or other liquids may also be injected through the injection needle.

[0047] In the present disclosure, the scavenging solution is injected first, or mixed with the scavenging solution, or injected together with the scavenging solution. Use of anesthetic drugs such as lidocaine, which, when injected together, can eliminate any pain caused by denervation It is also expected.

[0048] Prior to advancing the infusion needle or infusion tube, the thickness and Multi-function devices are used to accurately measure structures and determine the correct injection depth of cautery agents. Single-slice CT scan, MRI, intravascular ultrasound (IVUS), or optical coherence tomography The use of imaging techniques such as optical coherence tomography (OCT) is also envisaged. The use of IVUS is particularly useful in targeting precise injection depth. This precise injection depth can then be set by utilizing the adjustable penetration depth feature. Or by selecting a suitable PTAC with a preset penetration depth for cauterizing fluid delivery. During manufacturing, different labels are printed on the packaging according to the penetration depth. The product code will be displayed.

[0049] For use in renal sympathetic nerve ablation, the preferred manually expandable ( The "push" PTAC guide tube is used in the following steps (see each step). The steps are not required and may be shortened or modified as will be appreciated by those skilled in the art. (see below): 1. Standard for cardiac catheter or septal cauterization, using a method similar to alcohol septal cauterization. Use standard techniques to sedate patients (using familiar analgesics and narcotic analgesics) ). 2. The first renal artery is accessed via the femoral or radial artery using standard arterial access techniques. The catheter is then engaged with the guide catheter that has been placed in position. 3. After flushing all the lumen, including the PTAC injection lumen, with saline, the PTAC was fixed. The distal end of the PTAC is advanced into the guide catheter with the attached distal guidewire. Continue until the radiopaque marker on the catheter or guide tube reaches the desired location within the renal artery. The distal portion of the PTAC is then advanced through the distal end of the guide catheter. 4. The proximal end of the PTAC is extended until the guide tube is fully extended toward the inner wall of the target vessel. An internal mechanism is used to manually advance the guide tube outside the hollow shaft. Visualize the radiopaque tip of the catheter to confirm expansion of the guide tube. 5. The infusion tube / infusion needle is then advanced coaxially through the guide tube to connect the renal artery The catheter is then inserted into the vein, through the internal elastic membrane (IEL) and the tunica media, and then through a pre-set catheter from the IEL. The external elastic membrane ( EEL) into the outer layer (the adventitia and / or periaventitial layer) of the renal artery vessel wall. Thus, the injection tube / injection needle is positioned to inject the nerve cautery agent into the adventitial or (adventitial) surface. The renal artery is delivered to a depth of 2-4 mm from the IEL. The normal thickness of the media in the renal artery is about 0.5 mm. In the embodiment of the penetration depth limiting feature disclosed herein, the guide tube The injection needle is located a fixed distance from the distal end of the catheter and has a distal opening. In the vein, the guide tube is inserted into the IEL, which is usually located on or near the inner wall of the target vessel. Plaque in the renal artery is identified by angiography, IVUS, or OCT. Or, if the intima is thickened due to neointimal hyperplasia, the distal end of the guide tube A penetration depth of 3mm to 6mm is required. Specific ones with larger preset penetration depths are available. to the practitioner using the product code (i.e., pre-programmed product) or the mechanism in the handle of the PTAC Possible adjustments are envisaged to facilitate response. is injected at a site distant from the stenosis and, if necessary, the stenosis is corrected by percutaneous transluminal coronary intervention (PCA). Treatment with I) is preferable. 6. Ethanol (ethyl alcohol), distilled water, hypertonic saline, hypotonic saline, phenol, glycerol, lidocaine, bupivacaine, tetracaine, benzocaine, Cautery fluids such as anthraxin, botulinum toxin, glycosides, or any suitable neurotoxic fluid. The injection should include injection of an appropriate amount of cauterizing agent into the vessel wall and / or into all areas of the vessel. A combination of two or more nerve cautery solutions or local anesthetics administered together into the outer space or sequential injections (a local anesthetic is administered first to reduce discomfort, followed by the delivery of the cauterizing agent) ), and / or hot liquid (or steam) or very cold (for cryoablation) liquids. The usual injection volume is 0.1 mL to 3.0 mL. This allows crossover and Multiple ablation zones (one for each injection tube / injection needle) are applied to create an ablation ring around the circumference of the target vessel. Either during a test injection prior to injection of a nerve cauterizing agent or during a therapeutic injection. In the method, a contrast agent can be added to allow visualization of the ablated area on an X-ray. When ethanol is used as the agent, a volume of less than 0.5 mL is sufficient. Not only is the necessary space, including the renal artery, completely filled, but it is also accidentally released into the renal artery. The amount is so small that even a small amount of blood is enough not to damage the kidneys of the patient. Typically 0.3 mL of ethanol is used. 7. Inject saline into the PTAC to remove the PAC containing the infusion tube with the distal infusion needle. Completely flush the cautery agent from the TAC injection lumen (dead space). This will allow the injection needle to During retraction into the AC, cauterizing agent is prevented from accidentally entering the renal artery. Accidental release into the renal artery may cause kidney damage. Distilled water, hypotonic saline When water or hypertonic saline is used as the cautery agent, or when the amount of cautery agent is small, This washing step can be omitted if the kidney is unlikely to be damaged by accidental release into the vein. If less than 0.5 mL of ethanol is required for cauterization, ethanol Flushing is unnecessary because 0.5 mL of blood in the normal bloodstream will not damage the kidneys. It is necessary. 8. Retract the PTAC infusion tube / needle into the guide tube. 9. Retract the guide tube into the hollow shaft of the PTAC. 10. In some cases, rotate the PTAC 30o~90o or The initial injection site may be moved 0.2 cm to 4 cm distal or proximal. If necessary, repeat the injection and inject into a second group to extend the denervation / nerve ablation. Creates a tissue damage loop. 11. Repeat the same procedure, step by step, on the other kidney (on the other side of the body). The tissue within the artery is cauterized. 12. Withdraw the PTAC completely from the guide catheter. 13. Remove all remaining devices from the patient's body.

[0050] The above procedure is simplified as follows: Catheter injection with saline is performed. No flushing of dead space / inlet space: 1. Standard method for cardiac catheter or septal cauterization, similar to alcohol septal cauterization, etc. Sedate the patient using appropriate techniques (use familiar analgesics and narcotic analgesics). 2. The first renal artery is accessed via the femoral or radial artery using standard arterial access techniques. The catheter is then positioned so that its distal end is engaged with a guide catheter that has been advanced beyond the ostium of the renal artery. Can. 3. Outside the patient's body, the needle guide element / guide tube and injection needle are fully extended. , and flush the injection lumen with cautery fluid. 4. While outside the patient's body, flush all lumens of the PTAC except the infusion lumen with saline. A sufficient amount of saline is flushed through the guide tube and the distal opening of the catheter to remove any residual Flush the cautery solution from the exterior surface of the PTAC. 5. Retract the injection needle and needle guide / guide tube. 6. Advance the PTAC through the guide catheter to the desired point within the renal artery. 7. Manually advance the needle directing element / guide tube. 8. The infusion tube / infusion needle is then advanced through the internal elastic membrane (IEL) to the desired depth. Can. 9. Inject the appropriate amount of cauterizing agent / fluid. 10. Retract the PTAC infusion tube / needle 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. If necessary, insert a guide catheter into the contralateral renal artery (on the opposite side of the body). Move. 14. Repeat steps 6 through 11. 15. Completely remove the PTAC from the guide catheter. 16. Remove all remaining devices from the patient's body.

[0051] The amount of cautery fluid that may leak from the retracting injection needle is significantly greater than the volume of dead space within the PTAC. This simplified procedure is safe because of the small size and size of the sample. Cautery solutions such as nitrile can be safely injected into the renal artery without causing kidney damage. Even if the entire volume of the blood leaked into the renal artery, the dead space would be less than 0.3 mL, so the renal Currently, less than 10% of the internal volume (i.e., less than 0.03 mL) is closed. leakage from the closed PTAC, so the simplified procedure above is very It is safe.

[0052] For use in renal sympathetic nerve ablation, the following procedure (each step is not essential and may vary) As will be appreciated by those skilled in the art, the present invention is disclosed herein in A PTAC with an ICM is used: 1. Standard method for cardiac catheter or septal cauterization, similar to alcohol septal cauterization, etc. Sedate the patient using techniques (using familiar analgesics and narcotic analgesics). 2. The first renal artery is accessed via the femoral or radial artery using standard arterial access techniques. Engage the deployed guide catheter. 3. After flushing all the lumens, including the injection lumen of the PTAC, with saline, Advance the distal end of the PTAC in the anchored position into the guide catheter. The guide catheter is then guided until the radiopaque marker on the tube reaches the desired location within the renal artery. Advance the distal portion of the PTAC through the distal end of the catheter. 4. The sheath is pulled back to allow the expandable guide tube with the ICM to penetrate the inner wall of the renal artery. If ICM is self-scaling, this deployment will be automatic. When expansion is controlled by a distal expansion control mechanism (ECM), the surgeon The ICM and guide tube are expanded by using the radiopaque tip of the guide tube. and / or visualize radiopaque markers on the ICM to confirm dilation. 5. The infusion tube / infusion needle is then advanced coaxially through the guide tube to connect the renal artery Penetrate the vein and pass through the internal elastic membrane (IEL) to deliver nerve cautery agents deep to the adventitial surface. Therefore, the IEL should be placed at a preset distance (usually 0.5 mm to 4 mm, preferably 2 mm to 4 mm) into the outer layer (the adventitia and / or periadventitial layer) of the renal artery vessel wall. At a depth of 2 to 4 mm from the IEL, damage to the intima and media of the renal artery is minimal. do. 6. Ethanol (ethyl alcohol), distilled water, hypertonic saline, hypotonic saline, phenol, glycerol, lidocaine, bupivacaine, tetracaine, benzocaine, Cautery fluids such as anthraxin, botulinum toxin, glycosides, or any suitable neurotoxic fluid. The injection should include injection of an appropriate amount of cauterizing agent into the vessel wall and / or into all areas of the vessel. A combination of two or more nerve cautery solutions or local anesthetics administered together into the outer space or sequential injections (a local anesthetic is administered first to reduce discomfort, followed by the delivery of the cauterizing agent) ), and / or hot liquid (or steam) or very cold (for cryoablation) liquids. The usual injection volume is 0.1mL to 5mL. This allows for cross-sectional and target Multiple ablation zones (one for each injection tube / injection needle) forming an ablation ring around the circumference of the vessel Either during a test injection prior to injection of the nerve cauterizing agent or during the therapeutic injection, In some cases, a contrast agent can be added to allow visualization of the ablated area on an x-ray. When using ethanol as a stimulant, a volume of less than 0.5 mL is sufficient. Not only is the necessary space to contain the blood completely filled, but even if it is accidentally released into the renal artery, it will not cause any patient suffering. This is because the amount is so small that it will not damage the kidneys of the patient. Ideally, it should be between 0.1 mL and 0.3 mL of ethanol is used. 7. Inject saline into the PTAC to remove the PAC containing the infusion tube with the distal infusion needle. Completely flush the cautery agent from the TAC injection lumen (dead space). This will allow the injection needle to During retraction into the AC, cauterizing agent is prevented from accidentally entering the renal artery. Accidental release into the renal artery may cause kidney damage. Distilled water, hypotonic saline When water or hypertonic saline is used as the cautery agent, or when the amount of cautery agent is small, This washing step can be omitted if the kidney is unlikely to be damaged by accidental release into the vein. It can be omitted. 8. The PTAC injection tube / injection needle is retracted into the guide tube. Then, IC Retract the guide tube with M back under the sheath to completely enclose the sharp injection needle. The entire PTAC is then pulled back into the guide catheter. 9. In some cases, rotate the PTAC 30o~90o or first The injection site can be moved 0.2 cm to 4 cm distal or proximal to the injection site. If necessary, repeat the injection to extend the denervation / nerve ablation to a second tissue. Creates a damage loop. 10. Repeat the same procedure, step by step, on the other kidney (on the other side of the body). The tissue within the artery is cauterized. 11. Withdraw the PTAC completely from the guide catheter. 12. Remove all remaining devices from the patient's body.

[0053] In both embodiments of the present application, the penetration of the injection needle into the vessel wall is performed as described in the above method. A means of restricting entry is contained within the proximal portion of the PTAC. One or more handles are provided to cause the expansion of the tube and then the advancement of the injection needle. It is assumed that when these mechanisms are operated in reverse, the injection needle retracts into the guide tube, and After this, the guide tube is retracted into the catheter body or under the sheath. , U.S. Patent Application Nos. 13 / 643,070, 13 / 643,066, and 13 / 643,065, a sheath, a guide tube with a distal injection needle, and an injection tube The authors describe control mechanisms for the advancement and retraction of distal structures such as the scapula. Interlocks and locking mechanisms to prevent out-of-procedure movement are also described.

[0054] In addition, Fischell et al. The embodiments disclosed herein have similar structures and control mechanisms in the proximal portion. Usually, the middle section of the catheter has three concentric tubes. In some embodiments, there is an outer tube that forms the body of the catheter. The inner tube controls the advancement and retraction of the inner tube, and the inner tube is an infusion tube having a distal infusion needle. The lumen of the inner tube also connects to an injection port in the proximal part of the PTAC. The injected cauterizing fluid is conveyed to the injection tube and the lumen of the injection needle, and finally to the distal end or It has a lumen which discharges from a distal opening adjacent it.

[0055] Another important feature of the PTAC disclosed herein is that the catheter can be used to deliver cauterizing fluid to multiple locations where it is desired. To minimize the amount of saline required to flush into the tissue, the internal volume of the PTAC was Its design reduces the amount of dead space ("dead space"). Perivascular renal denervation (PVRD) requires 0. Less than 5 mL of ethanol or other cautery fluid is expected to be required. Dead space should be less than 0.5 mL. should be less than 0.2 mL, ideally. Several design features It is envisioned that the dead space can be reduced to less than 0.1 mL. Small diameter hypotubes with an inner diameter of less than 0.5 mm are used as inner tubes for liquid injection. The hypotube includes a reduced internal volume of the hypotube, resulting in To reduce the dead space of the PTAC, a hypotube / inner tube is placed inside the entire length. and / or has an internal diameter of less than 0.5 mm and a length of less than 2 cm By reducing the volume of the proximal injection port and / or the injection manifold at the proximal end of the PTAC, Designed to suppress.

[0056] The guide tube is a needle guiding element for an advanceable, very thin-walled injection needle; This is one of the important features of the present invention. Prior art Jacobson et al. describes a curved needle that advances outwardly from the catheter. In this case, the needle is unshrouded as it advances from the distal end or side of the catheter. ) and generally are not thick enough to cause bleeding after retraction from the arterial wall, making them fragile. Therefore, the catheter cannot reliably penetrate into the vessel wall as desired. An important aspect of the disclosed embodiments is that a very thin injection needle is desired within the inner wall of the target vessel. Including a needle guidance element, such as a guide tube, to allow reliable advancement to depth. Such a guide element need not be a tube or have a round cross section. Instead, the structure may be a half tube or partial tube, and has a slot for guiding an advanceable needle. Preferably, the guidance structure is a spring-like expansion structure that expands outward to provide radial support and guidance for the needle. The term "expandable" refers to any structure that is expandable relative to the longitudinal axis of the catheter. Movement of the structure from a first position relatively close to the longitudinal axis to a second position relatively far from the longitudinal axis. This means that the movement may be by expansion, bending, pivoting, or other mechanisms. It is desirable for the needle directing elements to extend outwardly from the central catheter.

[0057] What is unique about the embodiments disclosed herein is the ability to move the needle guide elements radially and laterally. Another advantage is that other structures that support the needles in the same direction can be used. The use of a different structure is important because the needle is advanced and the "guiding element" (e.g. The guide element is guided by a guide tube (e.g., a guide tube) while the needle is unsupported. The present disclosure also provides a method for retracting the catheter from a desired location toward the inner wall of a vessel. The needle guide element is radially supported so as to prevent retraction from the inner surface as the needle advances into the vessel wall. This paper teaches how to design structures that will support (back up) the load.

[0058] In another embodiment of the present disclosure, the guide tube and the injection tube are integrated into a single injection tube. Combining them simplifies the structure, which also reduces the number of steps required for operation. Specifically, the injection needle is permanently inserted inside an 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 is It acts as a "plug" that limits penetration into the inner wall of the target vessel.

[0059] In yet another embodiment of the present disclosure, an injection tube having a distal needle and advanced into the inner wall of a target vessel is provided. An inflatable balloon is used to expand the guide tube through which the catheter passes. The balloon may be flexible, semi-flexible, or inflexible. However, the inflation pressure of the balloon may be changed. The diameter of the outer edge of the expanded guide tube can be easily set by adding an elastic A flexible balloon is preferred. A guide tube can be attached to the outside of the balloon to provide a guide tube. The structure is simpler than when the guide tube is placed inside the balloon, and the guide tube can be placed farther away. The distal end is engageable with the inner wall of the target vessel such that the surface of the balloon contacts the inner wall of the target vessel. If the balloon comes into contact with the inner wall, the endothelial cells will be dislodged, resulting in undesirable In balloon-expanded embodiments, the guide tube The injection tube combined with the needle expands the injection needle outward when the balloon is inflated. In balloon-expanded embodiments, the balloon is expanded by a force of 100 MPa to penetrate into the inner wall of the target vessel. Containing the possible distal portion to facilitate delivery and during handling, insertion, and removal of the catheter A sheath may also be used to reduce needle stick injuries. The balloon is attached to the outside of the balloon to allow the thin injection needle to penetrate the inner wall of the target vessel. The catheter is supported radially and laterally to ensure uniform expansion.

[0060] Another feature of the present embodiment is that the injection port for injecting the cauterizing fluid is specially designed with a small diameter lumen. The present application also uses a special connector for the injection port that is paired with a special connector for the injection port. Such a syringe is envisioned to deliver a fluid that is injected into the interior wall of the target vessel, including the cauterizing fluid. to flush the infusion tube before inserting the PTAC into the target vessel. The saline used may comprise any suitable amount.

[0061] Another feature of the PTAC disclosed herein is that the flow through the multiple needles is synchronized to ensure that each of the injection needles The aim is to achieve uniform circumferential delivery of cauterizing fluid from the tip.

[0062] Yet another feature of the PTAC disclosed herein is that the distal portion is adapted to reach a desired location within the renal artery. The advantage of this is that the operator can fix the longitudinal movement of the catheter after the catheter is inserted. Several methods can be implemented using the many specific features of the PTAC as described herein. These methods include: 1. Close the Tuohy-Borst valve at the proximal end of the renal guide catheter to allow for the PTAC Makes vertical movement impossible. 2. Use an adhesive pad or Velcro to attach the proximal portion of the PTAC to the patient's skin or guide Secure it firmly to the proximal end of the catheter. 3. The proximal part of the PTAC, which fixes the longitudinal movement of the PTAC relative to the guide catheter The mechanism is located in the handle or inside the handle. The mechanism includes: a. Slide the clip over the outside of the PTAC until it locks onto the outside of the proximal end of the guide catheter. Gently move the clip distally over the surface. Once locked onto the guide catheter, the clip , which acts as a friction lock against the vertical axis of the PTAC. b. PT that activates the locking tube, guide tube and / or injection tube A guide catheter where the mechanism in the proximal part / handle of the AC and the proximal end of the locking tube are joined. Smoothly move the locking tube distally into the proximal portion of the catheter. When the catheter is rotated or turned, the distal portion of the locking tube engages the proximal portion of the guide catheter. Prevent longitudinal movement of the PTAC, e.g. by increasing the diameter of the locking tube. and the Tuohy-Borst valve or locking tube itself at the proximal end of the guide catheter. The friction locks against one of the inner surfaces of the

[0063] Thus, one feature of the PTAC disclosed herein is that the injection needle injects cauterizing fluid into the outside of the renal artery. An expandable supported needle guide for advancing through the layer or through its depth for injection therein 2. Having a percutaneously delivered catheter having a catheter element, Thus, damage to the intimal and medial layers of the renal artery is reduced or prevented.

[0064] In another aspect of the present application, the PTAC comprises a manually expandable catheter that is advanced outwardly from the body of the PTAC. The PTAC is designed with a guide tube / needle guidance element, and the PTAC A support structure is provided to radially support the guide element against the inner wall of the target vessel.

[0065] In another aspect of the present disclosure, the PTAC has a distal opening in a distal portion of the PTAC body. The design has a manually extendable guide tube / needle directing element that advances outward from the hollow shaft. The hollow shaft and the opening laterally support the guide tube / needle guiding element and are circumferentially / Ensure uniform and symmetrical lateral expansion. For example, use three guide tubes / needle guides. When using a needle guide element, the guide tube / needle guidance element provides lateral support as it expands outward. This ensures that an angle of approximately 120° is maintained between adjacent guide tubes / needle directing elements. .

[0066] In another aspect of the embodiment of the PTAC disclosed herein, the PTAC is An injection tube attached to the needle guide element and having a distal injection needle is inserted into the guide tube / needle guide. The guide tube / needle directing element is guided through the target vessel as it advances through the element and into the perivascular space. Further radial support or backup to prevent being pushed off the wall The device has an intraluminal central location mechanism (ICM) that

[0067] In another embodiment of the PTAC of the present disclosure, the PTAC is attached to a guide tube / needle directing element. The guide tube is supported by an intraluminal central alignment device that provides additional lateral support and promotes uniform expansion of the guide tube. It has an ICM (Interlocking Mechanism).

[0068] In yet another embodiment of the PTAC of the present application, the PTAC comprises: An intraluminal central placement reduces the possibility of trauma to the inner wall and guides the penetration of the injection needle for tissue ablation. It has an ICM (Interlocking Mechanism).

[0069] In yet another aspect of the present disclosure, a two-stage injection method for renal denervation is provided, comprising: Before inserting the catheter into the patient's body, the catheter is first filled with saline and the injection needle is deployed. An initial injection of cauterizing fluid (e.g., ethanol) is then performed, which is non-toxic to the kidneys. 100 ml of saline or similar fluid to flush all cautery fluid out of the catheter dead space. The PTAC is then closed and the same injection procedure is repeated in the other renal artery.

[0070] In yet another aspect of the present application, a one-step injection method for denervating each renal artery is provided. Before inserting the catheter into the patient's body, the catheter was first filled with cauterizing fluid and the injection needle was deployed. Afterwards, a single injection of cauterizing fluid (e.g., ethanol) is performed. The PTAC is then closed. Then repeat the same injection procedure in the other renal artery.

[0071] In yet another aspect of the present disclosure, the PTACs each have a radiopaque marker. , at least three guide tube / needle guiding elements. These guide tubes / needles The guide elements are manually extendable outward from the set of hollow shafts, and the set of hollow shafts are each Further supporting and backing up the guide tube / needle guide element against the inner wall of the target vessel. Activate the mechanism within the proximal portion of the PTAC to expand the guide tube / needle directing element. Complete the stretch.

[0072] In yet another aspect of the invention, a curved, expandable infusion tube is provided with an infusion needle; The injection needle can be advanced coaxially through the guide tube. The radius of curvature is similar to the radius of curvature of the guide tube.

[0073] In yet another aspect of the present embodiment, a guide tube and an injection tube are combined. The present invention provides an injection tube having a thickened proximal portion, which is a penetration control portion. The implant can be fabricated to act as a limiting mechanism and set a specific injection depth.

[0074] In yet another aspect of the PTAC of the present disclosure, the guide tube / needle directing element and / or distal Expandable balloon for radially expanding and supporting an injection tube having an injection needle is used.

[0075] Yet another aspect of the present PTAC is to provide multiple infusion needles with approximately the same flow resistance.

[0076] In yet another aspect of the PTAC of the present disclosure, the PTAC includes a PTAC positioning, opening, closing, and The device includes a chain and one or more radiopaque markers to aid in its use. Radiopaque markers include: · A radiopaque ring marking the distal end of the sheath; A radioactive material such as barium or tungsten is placed at or near the end of the guide tube. A radiopaque marker made of a metal strip or plastic with a radiopaque filler. car; · A radiopaque marker on the distal part 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] [Figure 1] FIG. 1 is a longitudinal cross-sectional view of the distal portion of an intraluminal nerve ablation system (INAS) having a guidewire fixed at its distal end. [Diagram 2] FIG. 2 is a schematic diagram of the distal portion of the PTAC in its expanded position when manually expanded for delivery of ablation agent into the perivascular space. [Diagram 3] 3 is a longitudinal cross-sectional view of a distal portion of the PTAC of FIG. 2 in its expanded position when configured for delivery of ablation solution into a target vessel wall. [Figure 4] FIG. 4 is an enlarged view of region S4 of the PTAC of FIG. [Diagram 5]FIG. 5 is an enlarged view of region S5 of the PTAC of FIG. [Figure 6] FIG. 6 is a cross-sectional view of the enlarged longitudinal section of the PTAC shown in FIG. 5 at section 6-6. [Figure 7] FIG. 7 is a cross-sectional view of the enlarged longitudinal section of the PTAC shown in FIG. 5 at section 7-7. [Figure 8] FIG. 8 is a schematic diagram of a distal portion of a manually expandable embodiment of a PTAC disclosed herein in its pre-deployed state advanced out of a guide catheter and into a renal artery. [Figure 9] FIG. 9 is a schematic diagram of the distal portion of a manually expandable embodiment of a PTAC after a guide tube has been manually advanced toward the inner wall of the renal artery. [Figure 10] FIG. 10 is a schematic diagram of the distal portion of a manually expandable embodiment of a PTAC after the injection tube with the distal injection needle has exited the guide tube and advanced to a desired penetration depth deep into the inner wall of the renal artery. [Figure 11] FIG. 11 is a schematic diagram of the handle on the proximal region of the PTAC. [Figure 12] FIG. 12 is a cross-sectional view of the distal portion of one embodiment of an endoluminal central placement mechanism (ICM), showing a wire cage with radiopaque markers that radially and laterally supports a guide tube through which an injection tube with a distal needle passes as it is advanced toward the inner wall of a vessel such as the renal artery. [Figure 13] FIG. 13 is an enlarged view of region S13 of the intraluminal central placement feature (ICM) of FIG. [Figure 14] FIG. 14 is an enlarged view of a region S14 shown in FIG. [Figure 15] FIG. 15 is a longitudinal cross-sectional view of the distal portion of another embodiment in which the guide tube and injection tube of the PTAC are combined within a single injection tube and advanced to penetrate the inner wall of the target vessel. [Figure 16]FIG. 16 is a longitudinal cross-sectional view of yet another embodiment that uses an inflatable balloon to advance the guide tube outwardly and provide radial and lateral support as the guide tube engages the inner wall of the target vessel. [Figure 17] FIG. 17 is a schematic diagram of the central support of the PTAC of FIGS. [Figure 18] FIG. 18 is a longitudinal cross-sectional view of the center of a PTAC showing multiple sections of the inner, intermediate, and outer tubes. [Figure 19] FIG. 19 is a schematic diagram showing the arrangement of the sharpened infusion needle as it emerges from the distal end of the PTAC. [Figure 20] FIG. 20 is a schematic diagram of a preferred shape of a sharpened injection needle. [Figure 21A] FIG. 21A is a schematic diagram of another embodiment of a PTAC that uses a proximal portion of an obturator as a support structure, showing the configuration of the PTAC with the guide tube advanced but the injection needle not yet advanced. [Figure 21B] FIG. 21B is a schematic diagram of another embodiment of a PTAC in which the proximal portion of the obturator further supports a guide tube. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0080] FIG. 1 is a schematic diagram of a conventional 3D printer, as shown in U.S. Patent Application Serial No. 2012 / 012023444 to Fischell. 1 is a longitudinal cross-sectional view of the expanded distal portion of the invention described in US Pat. No. 5,333,070. The transcatheter ablation system (INAS) 50 includes a fixed guide having a tip 28 at its distal end. FIG. 1 shows the self-expanding guide tube in a fully deployed state. The catheter 15, the coaxial injection tube 16, the pointed distal injection needle 19, and the guide tube 15 INAS 5 having a needle distal opening 17, which is an injection outlet, located outside the distal end 29 In this embodiment of the INAS 50, the four guide tubes 15 It should be understood that there are four injection tubes 16 protruding from the guide tube. The needle 15 is a thin-walled, flexible injection tube 16 having a distal injection needle 19 inserted into the inner wall of the target vessel. The needle is a guide element that supports the needle as it penetrates the

[0081] In this configuration, the sheath 22 is retracted and includes a radiopaque marker band 27. The guide tube 15 can be expanded outward. If the device is not made of transparent metal, standard fluoroscopy should be used to guide placement of the INAS 50. To better visualize the endoscopic images, the distal portions of the injection tube 16 and the guide tube 15 are made of gold or Marking with a radiopaque material such as tantalum or marking the injection tube 16 or tip The distal injection needle 19 may be made of a radiopaque material or may be injected with a radiopaque material. It is envisioned that the catheter may be placed in the inlet tube 16 or in the pointed distal injection needle 19. The location of the injection tube 16 with the distal injection needle 19 can be clearly identified by the practitioner under fluoroscopy. 1 shows a radiopaque wire 18 disposed within the infusion tube 16 to allow for easy access to the catheter. Knowing the location of the injection needle 19 after it has advanced through the inner wall of the vessel provides the practitioner with Materials for the radiopaque wire 18 include platinum, tungsten, Alternatively, the material may be selected from well-known radiopaque metals such as gold or alloys of such metals. Cut.

[0082] Diameter L1 indicates the shape memory of the fully expanded guide tube 15. For this purpose, L1 is usually 3 mm to 10 mm, but may be extended if the renal artery diameter exceeds 7 mm. Therefore, if only one size is used, 8 mm is the best. As such, the distal end 29 of the guide tube 15 in its fully expanded state is The distal portion of the INAS 50 has a tapered portion 26, a radiopaque portion. The catheter includes a permeable marker band 24 and a proximal portion 23. The catheter includes elements 23, 24, and 26. This tapered portion is called the occlusion portion 30. The occlusion portion 30 is connected to the core wire 11 and the guide tube. The occlusion 3 is fixedly attached to the outer layer 25 of the tube 20. Another important feature of this design is that The radiopaque marker band 24 on the distal end of the sheath 22 and the occlusion portion 30 are shown in FIG. A radiopaque marker 13 is located at the distal end of the sheath 22 to provide useful location information. The radiopaque marker 13 located at the distal end of the sheath 22 marks the occlusion site. When the injection tube is in close proximity to the radiopaque marker band 24 of 30, the practitioner may It can be seen that the guide tube 15 including the tube 16 is completely retracted. If the radiopaque markers 13 are far enough apart, the practitioner will see at least the guide tube 15 are disposed outwardly of each other and their distal ends 29 are in contact with the inner surface of the vessel. An injection tube 16 having a distal injection needle 19 is coaxially advanced into the guide tube 1. When the guide tube 15 penetrates the inner wall of the target vessel through the guide tube 15, the guide tube 15 is in contact with the inner wall of the target vessel. The typically preformed radius of curvature of the inlet tube 16 guides the inlet tube 16 to maintain its position. The radius of curvature of the guide tube 15 should match that of the guide tube 15, as described in U.S. Pat. As discussed above, the limitations of this design are that it is self-centering within the target vessel. The unsupported self-expanding needle guide element structure, such as the guide tube 15, cannot be supported. The guide tube 15, which does not have any radial support, is very difficult to install. During advancement of the intubation tube 16, it may become detached from the inner wall of the target vessel.

[0083] FIG. 2 is a schematic diagram of the distal portion of the PTAC 100 in its expanded position, with the outer tube The probe 102 has a radiopaque marker 122 and is advanced outside the body of the PTAC 100. an outer tube extension 104 having a distal opening 131 through which a guide tube 115 passes; 1 shows a fixed guidewire 101 having a tapered portion 106 and a distal tip 109. 10 is also shown. Infusion tube 110 has a distal infusion needle 119 and a needle distal opening 117. 16 is shown in its fully deployed position. Opening 131 allows distal injection needle 119 When the guide tube 115 advances outwardly prior to the advancement of the injection tube 116 having The PTAC 100 in FIG. The catheter has a third guide tube, which is hidden behind the catheter. The PTAC 100 of FIG. 2 has three guide tubes 115. In other embodiments, the number of guide tubes can be as few as one or as many as eight. The optimal number of guide tubes is three or four, although it may be possible to use more than one. As the size increases, the number of guide tubes 115 and injection tubes 11 may increase from four to eight. You will be using 6.

[0084] A distal opening (or Different shapes are also envisioned for the window 131. These possible shapes include curved ( For example, rounded (proximal and distal) ends, straight axial sides, and an oval or round shape. A removable cap to cover the opening 131 or a P Slits provided to smooth the outer surface of the TAC are also contemplated.

[0085] The guide tube 115 is a needle guide element for a very thin injection needle 119. Specifically, the catheter advances outward from the central catheter and strikes the inner wall of the target vessel end. In the prior art of Jacobson et al., which describes a penetrating curved needle, the needle is It advances by itself from the distal end or side of the catheter. If the catheter is not backed up, there is no risk of bleeding after penetrating and retracting into the arterial wall. Needles as thin as this are generally too fragile to reliably penetrate into the vessel wall as desired. Therefore, an important aspect of the present PTAC 100 is that the very thin needle 119 is 3. The guide tube 115 allows the catheter to be reliably advanced to a desired depth within the wall of the target vessel. It is envisioned that the needle guide element may include, for example, a needle guide element such as a needle guide element.

[0086] FIG. 3 is a longitudinal cross-sectional view of the distal portion of the PTAC 100 shown in FIG. forms the center of the PTAC 100 and occupies most of its length. , three concentric tubes, an outer tube 102, a middle tube 103, and an inner tube 1 05 is shown. Outer tube 102 is connected to outer tube extension 104. The outer tube extension 104 is connected to the tapered portion 106. and a fixed guidewire 110 having an outer layer 113 extending from the distal end of the tapered portion 106. Only a portion of the length of guidewire 110 is shown in FIG. It should be noted that the entire length of the guidewire 110 is shown in FIG. Sections S4 and S5 are shown in Figures 4 and 5, respectively.

[0087] In FIG. 3, a guide tube 115 having a radiopaque marker 122 is attached to the outer tube. It is shown fully advanced through opening 131 in tube extension 104. The inner surface of the outer tube extension 104 that forms a portion of 120 is The actuator is made of metal or high durometer plastic so that it is relatively stiff when moving forward and backward. The support should be made of a rigid material such as wood.

[0088] In a preferred embodiment of the present PTAC 100, an outer tube 102 and an outer tube Four different tubular structures have been used in place of the extension 104. The proximal portion of the PTAC is a metal hypotube 82 shown in FIG. The hypotube 82 is a rigid plastic tube approximately 20 cm long at its distal end. 18, the rigid plastic tube 92 is connected to the The tube 102 shown in FIG. 7 is a more flexible and higher The tube is usually made of plastic and has high flexibility. 92 and 102 have the same inner and outer diameters. The outer tube extension 104 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 a coaxial The catheter of the PTAC 100 is essentially inside the plastic tubes 92 and 102. At least a few centimeters proximal to the outer tube extension 104, which is the distal end of the terminal body. is located.

[0089] In a preferred embodiment, the distal metallic hypotube and the inner tube 105 are connected The intermediate tube 103 connected to the proximal section is also made of a metal hypotube. The structure of these tubes is shown in Figure 18.

[0090] An important aspect of the PTAC 100 disclosed herein is the internal volume of the injection pathway, i.e., the "dead space." By minimizing the dead space, the perivascular space is filled before the cauterizing fluid is injected. In one version of the method, the amount of liquid required to be injected into the PTA is reduced. Before inserting the C100 into the patient's body, the dead space outside the body must first be flushed with saline. The dead space is then filled with saline. Ideally, the dead space should be less than 0.3 mL. If possible, this should be approximately 0.1 mL. If less than 0.5 mL, the amount should be increased prior to injection of cautery solution. This is useful in minimizing the amount of flushing fluid injected into the perivascular space.

[0091] The central support 121 shown in FIG. 3 supports the guide tube 115 during distal advancement and The central support 121 supports the injection tube 1 both when the tube is in the fully deployed state and after it is fully deployed. 16 guides 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 as it advances therethrough. The guide tube 115 is supported primarily in the radial direction to prevent the guide tube 115 from moving forward. In this example, the injection needle 119 at the distal end of the injection tube 116 is 8 mm from the inner wall of the target vessel. The lateral support of the guide tube 115 is provided primarily by the sides of the opening 131. The opening 131 is formed by a surface, and the opening 131 is connected to the central support portion 121 and the guide tube 1. 15 provides radial and circumferential / lateral support as it advances and expands outward. It also serves as a backup during delivery of the injection needle 119 through the inner wall of the target vessel. The support 121 may include a flexure surface, such as a curved or linear slope. In the embodiment where the curved surface is curved, the radius of curvature is the radius of curvature of the distal surface of the guide tube 115. In the case of a curved ramp embodiment, the central support 121 and the central The hollow shaft 120 is laterally spaced to facilitate radial expansion of the guide tube 115 only. The central support 121 also supports the guide tube 115 in the radial and lateral directions. In other embodiments described herein, the support is radially only or laterally only. The radial support of the guide tube 115 can be achieved by 115 perpendicular to the longitudinal axis of the PTAC 100 is defined herein as supporting the PTAC 100 in a direction perpendicular to the longitudinal axis of the PTAC 100. Supporting the guide tube 115 laterally allows the guide tube 115 to be supported radially perpendicular to the Circumferential support at an angle is defined herein as circumferential support.

[0092] The radius of curvature of the central axis of the distal portion of the injection tube 116 is measured in an unconstrained state. The central axis of the tube 115 and the distal portion of the hollow shaft 120 formed in the central support portion 121 Another important feature is that the radius of curvature of the guide shaft is the same as, or close to, the radius of curvature of the guide shaft. The length of the tube 115 is determined by the distal curved portion of the injection tube 116 having a distal needle 119. This design ensures that each inlet tube 1 The curved portion of the guide tube 115 is constrained within the lumen of the guide tube 115, and the injection tube 116 is prevented from twisting. There will be no movement or displacement.

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

[0094] As can be seen in FIG. 3, the inner tube 105 having the liquid injection lumen 133 is connected to the connecting tube 1. 25 to three injection tubes 116, so that the injection tubes The lumen of 116 is in fluid communication with the liquid infusion lumen 133. The connecting tube 125 has a constant diameter over its entire length, including the coaxial outer portion of the connecting tube 125. The PTAC 100 moves smoothly along the longitudinal axis of the PTAC 100 within a certain intermediate tube 103. can be done.

[0095] As can be seen from FIG. 3, the connecting tube 125 is disposed within the lumen of the inner tube 105 and is connected to the distal end of the inner tube 105. It is clear that the inner tube 105 and the inner tube 106 are located in the proximal portion of the distal end of the catheter. The connecting tube 125 and the connecting tube 126 are both coaxially connected to the P Proximal to the outer tube extension 104, which is the distal end portion of the outer body of the TAC 100 This is because the connecting tube that connects the tube to the needle is located at the distal end of the tube ( on its inner side and not proximal to the distal end), This is significantly different from the embodiment shown in FIG. 3 of Patent No. 6,302,870 to I. In addition, the Jacobson connecting tube is coaxially inserted into the distal end of the catheter body (catheter The distal end of the catheter is located proximal to the distal end of the catheter (not inside the tube). The end portion is the distal portion of the catheter from which the needle emerges and curves outward into the inner wall of the vessel. , is defined.

[0096] The flow through the needle distal opening 117 of each of the needles 119 of the PTAC 100 of FIGS. Near-uniform flow rates may also be an important feature of the PTAC 100. This is because each injection tube 116 having an injection needle 119 is pre-tested to ensure that it meets the required pressure. This can be verified quite simply by measuring the flow rate and flow resistance under force. Based on the results, the injection tubes 116 can be sorted, each with a PTAC 100 The injection tubes selected for this purpose are matched so that the flow resistance is approximately the same.

[0097] FIG. 4 is an enlarged view of region S4 of the cross-sectional view of PTAC 100 shown in FIG. , an inner layer 123, an outer layer 127, a distal end 129, and a radiopaque marker 122. The figure shows details of the guide tube 115. Included is an infusion tube 116 having a distal infusion needle 119, a distal opening 117, and a discharge port 118. The radiopaque marker wire 118 is First, the infusion tube delivers cauterizing fluid into the perivascular space and into the target vessel. The position of the injection tube is monitored fluoroscopically as it is advanced into position for delivery deep into the adventitia of the vessel. Second, the radiopaque marker wire 118 is positioned at the infusion tube 11. By reducing the internal volume of the 6, the PTAC 100 is retracted from the renal artery without causing any harmful physiological All cautery fluid was then pumped into the perivascular space outside the PTAC 100, leaving only the saline solution. Reduces the amount of saline needed for saline flush. The radiopacity of the injection tube 116 ensures that the needle 119 is appropriately positioned within the inner wall of the target vessel. This is very important because it allows the practitioner to confirm under fluoroscopy that the In other disclosed embodiments, the injection tube 116 and the injection needle 119 may be provided with a plurality of electrodes 116a and 116b. Alternatively, a coating, plating, or marking of the distal injection needle 119 may be used. The infusion tube 116 has two layers of coating material. The tube is then molded over a platinum inner tube, providing high visibility and the results shown in Figures 3 and 4. This is ideal because it eliminates the need for a radiopaque marker wire 118.

[0098] The guide tube 115 advances and retreats through a hollow shaft 120 having a distal opening 131. The three guide tubes 115 terminate at guide tube connectors 132 near their proximal ends. 4 also shows that the guides are in contact with each other as they advance toward the central support 121. The hollow tube 115 is supported by the curved inclination 144 of the central support portion 121 and the opening of the hollow shaft 120. It is clearly shown how the mouth 131 is directed outward and supported by the sides. The central support 121 also includes proximal fingers that provide further lateral support to the guide tube 115. The sensor 142 has a sensor section 142.

[0099] The outer tube extension 104 is connected at its distal end to a tapered portion 106. 6 is coaxially arranged around the guidewire 110 with the core wire 111 and the outer layer 113. is located.

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

[0101] The central support 121 and the distal opening 131 are disposed within the PTAC 100 as shown in FIG. They can be separate parts or, as shown in FIG. 17, they can be a single molded The distal tip 14 of the central support 121 may be formed as a part or a machined part. 5 connects and fixes the central support portion 121 to the tapered portion 106. The distal opening 131 and tapered portion 106 are a single molded or machined piece. It is possible.

[0102] In a preferred embodiment of the PTAC 100, the guide tube 115 is a preformed bayonet. Although it has a curved shape, the central support 121 guides the straight guide tube into the target vessel. Guide tube with natural straightness and flexibility when curved outward toward the wall It is also expected.

[0103] In this specification, the term "central support portion" is used, but the most important part of the central support portion 121 is The essential components are arranged to radially and to some extent laterally support the deployed guide tube 115. Specifically, the curved slope 144 of the central support portion 121 is Supports and supports the outward movement of the guide tube 115 as it exits through the distal opening 131. and guides the guide tube 115 and the injection tube 116 as they engage the inner wall of the target vessel. The fingers 142 of the central support 121 provide additional lateral support. .

[0104] The shape of the ramp 144 or the central support 121 allows the guide tube 115 to be positioned at the distal opening 13 1. A smooth, curved guide tube 115 that guides the guide tube 115 outward as it advances distally through the Also included is a proximal extension or finger having a surface or angled surface.

[0105] The central support portion 121 shown in FIG. 4 is a plastic part, but it is also possible to use stainless steel. Parts made of radiopaque metals such as tungsten or radiopaque fillers Plastic parts, including PTAC, may also be used. 100. The guide tube 115 and therefore the injection needle 119 are shown in FIG. A radiopaque marker is attached to the distal opening to similarly indicate the point of engagement with the inner wall of the target vessel. The support portion 131, the central support portion 121, or the outer tube extension portion 104 may be disposed or attached to the It is also expected to be added.

[0106] Typically, many of the PTAC 100 parts are made of polyamide, polyurethane, nylon, or Plus such as Techothane (registered trademark, a type of thermoplastic polyurethane) These plastic parts include an outer tube 102, a middle tube 103, and a Intermediate tube 103, inner tube 105, outer tube extension 104, guide tube The inner layer 123 and the outer layer 127 of the tube 115, the tapered portion 106, the central support portion 121, the guide The tube connector 132 and the connecting tube 125 are molded parts. Alternatively, an epoxy resin may be used to bond the inlet tube 116 to the inner tube 105. Silicone resin or other resins may also be used.

[0107] Either the inner tube 105, the intermediate tube 103, or the outer tube 102 It is also envisaged that all tubes will be metal hypotubes or metal-reinforced plastic tubes. do.

[0108] Typically, the infusion tube 116 is made of a spring or a shape memory metal such as Nitinol. Radiopaque marker wire 118 and guide tube radiopaque marker 12 2 is made of gold, platinum, or tantalum, or an alloy of these metals or similar metals. Typically, the core wire 111 is stainless steel and the outer layer 113 is The outer layer 113 is a polymer material. Any or some portion of the exterior of the PTAC 100 may have the characteristic For improvement, a lubricant coating may be applied. 9 is a diagram showing the state of the needle when the needle penetrates the inner wall of the target vessel and when the needle retracts from the inner wall of the target vessel. To avoid bleeding and leakage, the diameter should be less than 0.5 mm, preferably less than 0.3 mm. It is full.

[0109] FIG. 5 shows the outer tube 102, the intermediate tube 103, and the inner tube 104 along with the infusion lumen 133. 3 showing the transition from the central to the distal portion of the PTAC 100, including the tube 105. 1 is an enlarged view of a region S5 of the outer tube 102. In FIG. 5, the proximal end of the infusion tube 116 is connected to the proximal end of the manifold 125. However, for the purposes of manufacturing the PTAC 100, the proximal end of the infusion tube 116 is preferably located proximal to the proximal end of the connecting tube 125.

[0110] The guide tube connector 132 connects the three guide tubes 115 to the three guide tubes 115. Connected to the intermediate tube 103, which provides the tube 115 with thrust for forward and backward movement. This movement of the intermediate tube 103 is controlled by the movement of a control mechanism at the proximal end of the PTAC 100. The connecting tube 125 is located inside the distal portion of the inner tube 105 and has three The inner tube 105 is connected to either of the injection tubes 116, and the forward and backward movements of the inner tube 105 are simultaneously The flash between some tubes is interlocked with the forward and backward movement of the inlet tube 116. The singular space is also shown in FIG. 5. Specifically shown is the intermediate tube 103. and outer tube 102, and the outer annular gap 137 between the inner tube 105 and the intermediate tube and an inner annular gap 139 between the inner tube 103 and the inner annular gap 137. These gaps 137 and 139 are Each was flushed with saline prior to insertion of the PTAC 100 into the patient's body. Must be.

[0111] 5, the proximal end of the infusion tube 116 is connected to the infusion lumen 133 of the inner tube 105. It can also be seen how the fluid is in communication with the radioactive material located within the lumen of the infusion tube 116. An impermeable wire 118 extends proximally from the proximal end of the infusion tube 116 and connects the infusion tube 116 to the connecting tube 116. Instead of connecting to the body of the connecting tube 125, three radiation The impermeable wires may be welded together and / or attached to the proximal end of the connecting tube 125. It is assumed that the inner tube 105 moves longitudinally within the intermediate tube 103 of uniform diameter. also moves the manifold 125 and the injection tube 116 attached thereto vertically. This longitudinal movement, via a control mechanism near the proximal end of the TAC 100, is controlled by the guide tube. An infusion tube 116 is advanced and retracted through the lumen of 115 to expand outwardly and introduce blood into the target vessel. The inner wall of the tube is penetrated to facilitate delivery of cauterizing fluid.

[0112] FIG. 5 shows how the three injection tubes 116 are connected to the inner tube 105 and the connecting tube 125. Extending from the distal end of the guide tube 115 and then extending to the proximal end of the guide tube 115 Also shown is the guide tube 115 entering the lumen of the outer layer 127. The connector 132 is coaxially connected within the distal portion of the intermediate tube 103. The longitudinal movement of the intermediate tube 103 is caused by the guide tube connector 132 and the guide This induces longitudinal movement of the tube 115, and the proximal mechanism of the PTAC 100 moves outward. Advance the guide tube 115 relative to the tube 102 and the outer tube extension 104. This allows for the advancement and retreat of

[0113] The penetration depth limit determines the advancement of the inner tube 105 relative to the guide tube connector 132. It is also envisioned that the mechanism for limiting the distance between the distal ends of the inner tube 105 or the connection A ring or other structure located between the tube 125 and the proximal end of the guide tube connector 132. The structure limits the advancement (distal) of the inner tube 105 and prevents the needle 119 from entering the guide tube 106. Such a structure limits penetration of the inner tube 15 beyond the distal end 129 of the inner tube 15. 05, connecting tube 125, injection tube 116, guide tube connector 132, guide tube The proximal end of the tube 115 or intermediate tube 103 of the PTAC 100 shown in FIG. The inner structure may be non-attachable or attachable. Such structure may be a guide for the needle 119. A length adjustment such as a thread can be used to adjust the depth of penetration beyond the distal end 129 of the implant tube 115. It may also have an adjustment mechanism.

[0114] FIG. 6 is a cross-sectional view of the PTAC 100 shown in FIG. 5 at section 6-6. 6 includes an outer tube 102, an intermediate tube 103, an inner tube 105, and an intermediate tube 1 103 and the outer tube 102, and the inner tube 105 and the The coaxial components of the body of the PTAC 100 include an inner annular gap 139 between the inner tube 103 and the FIG. 6 shows how the connecting tube 125 is attached to the inside of the inner tube 105, which is radiopaque. Also shown is how three infusion tubes 116 with transient wires 118 are grouped together. do.

[0115] FIG. 7 is a cross-sectional view of the PTAC 100 shown in FIG. 5 at section 7-7. 7 is connected distally to an outer tube extension 104 that restrains the outside of the intermediate tube 103. 1 shows the coaxial arrangement of the outer tube 102. The guide tube connector 132 is Inside the guide tube connector 132, which itself is located inside the intermediate tube 103 The three guide tubes 115 have an outer plastic layer 127 positioned therebetween. With this structure, the vertical movement of the intermediate tube 103 is prevented by the guide tube connected thereto. Similar movements in the tube connector 132 and the guide tube 115 may occur.

[0116] 8-11 show how the PTAC 100 is used for perivascular renal denervation. FIG. 8 is a set of schematic diagrams of the outer tube 102, in its pre-deployed state. a distally fixed guide having a barbed extension 104, a tapered portion 106, and a distal end 109; A schematic diagram of the distal portion of the PTAC 100 with the wire 110 is shown. Two of the mouths 131 are shown on the surface of the outer tube extension 104. The distal portion of the PTAC 100 is inserted into the renal artery from the distal end of the renal guide catheter 140. The internal elastic tunica (IEL), tunica media, external elastic tunica (EEL), renal artery and The adventitia of the aorta and the ventricle are also shown.

[0117] FIG. 9 illustrates the guide tube 115 fully extended outward against the inner wall of the renal artery. 1 shows a schematic of the distal portion of the PTAC 100 within the renal artery. The renal artery and aorta are shown in cross section. Therefore, the lower guide tube 115 does not actually contact a portion of the inner wall of the renal artery. This is because the cross section is taken at 0o and 180o through the renal artery. The third guide tube 115 is not visible because it is composite. The guide tube is hidden behind the PTAC 100 because it is in contact with the inner surface of the guide tube. A radiopaque marker 122 on 115 indicates that the guide tube 115 is fully expanded. This allows the practitioner to visualize that the catheter is actually in contact with the inner wall of the renal artery. The side tube 115 exits through an opening 131 in the outer tube extension 104 to form an outer It is very important that the central support is provided laterally when the aircraft is deployed. The guide tube is supported radially and laterally by the support 121. This ensures that the guide tube expands uniformly and that the distal portion of the PTAC 100 is in line with the target vessel. This is very important as it is centrally located and allows the injection needle 119 to be deployed as shown in FIG. be.

[0118] FIG. 10 illustrates the injection tube 116 with the distal injection needle 119 fully deployed to deliver cauterizing fluid to the kidney. PTAC in the renal artery with delivery into the adventitia of the artery and / or into the deep perivascular space 1 shows a schematic of the distal portion of the injection needle 119. The needle distal opening 117 is located at the tip of the EEL, as shown for the upper needle 119 in FIG. The third needle 119 and the guide tube 115 should be placed outside the adventitia. It is hidden behind the main body of the TAC 100 and is not visible in Figure 10. The sensory nerves are located either within the adventitia or a few mm outside of it. In general, a position 2 mm to 4 mm behind the IEL is suitable for the needle distal opening 117. If the sympathetic nerve is located further back, a distance of 4mm to 8mm can be used. It is expected.

[0119] FIG. 11 illustrates the needle guide element / guide tube 1 during a procedure to deliver cauterizing fluid to the perivascular space. 15 and a control mechanism for advancing and retracting an injection tube 116 having a distal needle 119. FIG. 1 is a schematic diagram of an embodiment of a proximal portion 300 (i.e., handle) of a PTAC 100. The handle 300 is operated by a first control and a second control, such as push buttons 332 and 342. Specifically, the button 332, when pressed, locks the outer tube. Locking the movement of the guide tube control cylinder 333 against the guide tube control cylinder 335 The outer tube control cylinder 335 is attached to the outer tube 102. The transition 338 is connected to the outer tube control cylinder 335 to avoid kinking. The guide tube cylinder 333 relieves the connection tension between the outer tube 102 and the guide tube cylinder 333. 2 to 7, and the intermediate tube 103 is 0 guide tube 115.

[0120] The guide tube control mechanism 330 allows the user of the PTAC 100 to control the guide tube 11 5. The distal and proximal movement of the button 332 and the gusset 334 can be controlled. The injection needle control mechanism 340 includes a PTAC A user of 100 may move the infusion tube 116 having a distal infusion needle 119 distally and The button 342 and needle control cylinder 345 allow for control of the proximal movement of the needle. Contains.

[0121] Button 342, when depressed, moves the needle against guide tube control cylinder 333. The movement of the control cylinder 345 is unlocked. This allows the intermediate tube 10 in FIGS. 3, allowing relative longitudinal movement of the inner tube 105 with respect to the distal injection needle 119. An injection tube 116 having a guide tube 115 is advanced and retracted through the guide tube 115. do.

[0122] The handle 300 shown in FIG. 11 has a flushing port 344. Flushing port 344, having a Luer fitting, is shown with a lid 346. The flushing port 344 is connected to the annular gaps 137 and 139 shown in FIGS. Used to flush with saline. Usually has a cautery fluid connector fitting. The port 354 is shown with a lid 356. The injection port 354 is shown in FIG. 5 into lumen 133, which is in fluid communication with the lumen of injection tube 116. The lumen of the injection tube 116 is in fluid communication with the needle distal opening 117 .

[0123] In FIG. 11, one flushing port 344 is shown, but the PTAC 100 may have any number of flushing ports. Two or more flushing points are used to flush the internal space (other than the injection lumen) of the The two buttons 332 and 342 may be replaced by a single button and a single It is also envisioned that the piston mechanism may be replaced by a piston mechanism in the proximal portion of the PTAC 100. The telescoping mechanism allows the push of a single button to advance the guide tube 115 and then the distal infusion Advance the infusion tube 116 with needle 119. Release the single button depression. Then, the distal injection needle 119 is first retracted, and then the guide tube 115 is retracted.

[0124] The cautery fluid connector fitting at the injection port 354 is fitted with a standard Luer fitting or Luer rod. Although a special connector for injecting the cauterizing fluid is used, this specification This is a preferred feature of the PTAC 100 disclosed herein. Custom fittings at injection port 354 allow for one or more injection ports (e.g., 34 4) in a standard "Y" adapter, typically used with renal guide catheters This reduces the risk of accidental injection of cautery fluid into a standard Luer fitting. Flushing fluid or other medication in the uer lock syringe is injected through the lumen of the injection tube. Standard Luer connection, which minimizes the dead space / internal volume of the catheter. Another advantage is that a custom connection port with a smaller bore than the connector can be used. be.

[0125] A custom syringe with a custom fitting designed to connect to injection port 354 It may be offered in a separate package from the PTAC 100 or in the same package. A suitable syringe may be used to dispense a suitable amount of ethanol to achieve renal denervation, e.g., 0.25 mL. The cauterization fluid can be precisely contained in the correct amount. The volume of tissue to be treated is equal to the diameter of the renal artery. Since the internal volume changes with the temperature, the internal volume ranges from 0.1 mL to 0.5 mL, and each port is connected to the injection port 3. Several syringes are provided with special connectors that connect to 54. Saline If flushing with water or if injection of other fluids (e.g., contrast or anesthetic agents) is part of the procedure, If the agent is a part of the medicament, the appropriate amount and type for visualization, flushing, renal denervation, or pain relief may be used. Additional syringes containing the same fluid are provided. A cauterizing fluid injection syringe with a special fitting is provided. , what is the color or marking of the syringe for flushing through a port such as injection port 354? It is envisioned that they may have different colors or markings.

[0126] The handle 300 also extends beyond the distal end 129 of the guide tube 115 when rotated in one direction. 4, which reduces the penetration depth L2, which is the distance between the injection needles 119 extending from the If the cylinder 348 rotates in the other direction, the penetration depth L2 The PTAC 1 has markings on the handle 300 indicating the achievable spacing. It is envisioned that the spacing adjustment cylinder 348 is accessible to any user of the 00. In the preferred embodiment of the handle 300, the spacing adjustment cylinder 348 is factory This method of manufacture is only accessible during assembly and testing of the AC 100. In order to ensure proper calibration of the penetration depth L2 of each PTAC Pre-set at the factory during manufacturing and testing of 100. Accurately set and calibrate the penetration depth L2. The ability to correct this is critical to improving manufacturing yields. The relative lengths of the components of the PTAC 100, such as the PTAC 105 and the intermediate tube 103, are several mm. Even if the temperature varies, the penetration depth L2 can be precisely adjusted using the spacing adjustment cylinder 348. In a preferred embodiment, the PTAC 100 has a penetration depth L2 according to FIG. For example, the penetration depth L2 of PTAC 100 is 2.5 mm, 3 mm, and 3.5 mm. The screws are fitted with a thread or other mechanism (not shown). It is also contemplated that the spacing adjustment cylinder 348 can be locked at the desired penetration depth. Although a spacing adjustment cylinder 348 is shown herein, other mechanisms such as a moving cylinder may be used to adjust the penetration depth L It is also expected to be used to adjust 2.

[0127] Handle 300 functions to activate PTAC 100 for Perivascular Renal Denervation (PVRD) This procedure includes the following steps, but each step is not mandatory: However, as will be appreciated by those skilled in the art, it may be shortened or modified as follows: 1) Fill the entire volume of the PTAC 100 with saline via ports 344 and 354. Rush. 2) The PTAC 100 is inserted through the pre-placed guide catheter 140 of FIGS. 8 is inserted into the patient's renal artery at the desired site. Place in. 3) Press the button 332 to lock it against the guide tube control cylinder 333. While having an outer tube control cylinder 335, the notch 331 is connected to the port 344. The guide tube control cylinder 104 is engaged until it limits the forward movement of the intermediate tube 103 of FIG. 9, the opening 131 is opened from the inside of the hollow shaft 120. 2. Allow the guide tube 115 to fully deploy outwardly through the catheter. 4) Releasing the button 332 releases the outer chuck against the guide tube control cylinder 333. The relative movement of the tube control cylinder 335 is again locked. 5) Pressing button 342 activates the injection needle control for the guide tube control cylinder 333. This allows the relative movement of the outer tube control cylinder 335 (now and the guide tube control cylinder 333) while holding the The limiting mechanism stops the movement of the needle control cylinder 345 and the guide tube of the needle 119. The distal end 129 of the 115 is then pushed against the distal end 129 until a preset penetration depth L2 is achieved. 3. Advance the needle control cylinder 345 with the needle 349. This can be done in two ways: 1) Insert the injection needle control serial into the guide tube until it engages with the guide tube flush port 344. or 2) advancing the distal end 349 of the underside 345; 2, is brought into contact with the proximal end of spacing adjustment cylinder 348 inside undershade 345. 6) When the button 342 is released, the injection to the guide tube control cylinder 333 The relative movement of the needle control cylinder 345 is again locked. Now, the PTAC 100 10, the needle 119 penetrates the internal elastic membrane (IEL) and A preset distance (usually 0.5mm to 4mm, preferably around 2mm to 4mm) If the penetration depth is 2mm to 3mm, the intima and For some abnormal target vessels, penetration as large as 8 mm was observed. Depth is needed. 7) In this state, attach a syringe or a connecting tube with a syringe (not shown) to port 354. The desired amount of cautery fluid is then injected. The cautery fluid is typically ethanol (ethyl alcohol), steam, or other suitable solvent. Water, hypertonic saline, hypotonic saline, phenol, glycerol, lidocaine, bupivacaine bacine, tetracaine, benzocaine, guanethidine, botulinum toxin, glycosides, or The cauterizing fluid may be any suitable neurotoxic fluid. The injection may include intramural and / or endovascular A combination of two or more nerve cautery solutions or local anesthetics into the space just outside the Simultaneous or sequential injections (local anesthetic first to reduce discomfort, followed by cauterizing agent) and / or injecting hot liquid (or steam) or very cold (cryocautery) liquid. The usual injection volume is 0.1 mL to 5.0 mL. This prevents crosstalk. 2. The ablation zones (each injection tube / injection tube) are then inserted into the target vessel to form an ablation ring around the circumference of the target vessel. One per needle is generated either during a test injection prior to injection of a nerve cautery agent or during a therapeutic injection. In one of these, a contrast agent can be added that allows visualization of the ablation area on an x-ray. When using ethanol as the caustic agent, a volume of less than 0.5 mL is sufficient. Not only is the necessary space, including the nerve, completely filled, but it is also accidentally released into the renal artery. The amount is so small that it will not damage the kidneys of the patient if it is injected. Ideally, it should be no more than 0.1 ml. Between 0.1 and 0.3 mL of ethanol is used. The amount used is the same for all renal arteries. or may vary depending on the diameter of the renal artery into which the ethanol is injected. The hydrophilic and lipid-soluble nature of ethanol facilitates diffusion and makes even such small amounts effective. Before injecting the cauterizing agent or cauterizing liquid, the needle 119 in FIGS. 2 to 4 is extended into the vascular wall of the target vessel. It is advisable to confirm fluoroscopic patency. 8) Next, insert a syringe containing saline into port 354 instead of the syringe containing the cauterizing fluid. Ideally, to ensure that no cautery fluid is left inside the PTAC 100, Inject a volume of saline slightly larger than the total volume of dead space. For example, in the PTAC 100, If the dead space is 0.1 mL, for example, 0.1 mL to 0.15 mL of saline should be injected. 10, into the appropriate perivascular tissue via the distal opening 117 of the injection needle 119. This ensures that the cauterizing fluid is delivered to the patient. 9) Press the button 342 and, while holding the outer tube control cylinder 335, insert the injection needle 1 19 is fully retracted into the guide tube 115. The needle control cylinder 345 reaches the correct position and the needle 119 It is expected that there will be an audible click or lock when fully seated. 10) When the button 342 is released, the attention to the guide tube control cylinder 333 is The movement of the needle entry control cylinder 345 is locked. 11) Pressing the button 332 activates the outer tube against the guide tube control cylinder 333. The needle control cylinder 335 is then allowed to move relative to the needle control cylinder 345. is locked against 12) Guide tube control cylinder 33 against outer tube control cylinder 335 3 is retracted proximally. As a result, the guide tube 115 in the form of FIG. 100 , recessed within opening 131 in outer tube extension 104 . 13) The PTAC 100 is pulled back into the guide catheter 140. 14) Move the guide catheter 140 into another renal artery. 15) Repeat steps 3-13 for the other renal artery. 16) Remove the PTAC 100 from the patient's body.

[0128] Eliminating step 8 and replacing saline with saline outside the patient's body in step 1 Instead, flushing the internal volume / dead space with cautery fluid is highly advisable. It is believed that this is done with the catheter tube 115 and needle 119 fully deployed. Any cauterizing fluid remaining on the surface during flushing with the This technique involves the use of a PTAC catheter prior to advancement of the catheter into the patient's body to remove the catheter from the patient's body. It may also be desirable to use saline flushing of the distal portion of 100 .

[0129] As described above, buttons 332 and 342 are pressed to lock and released. , which allows the movement of control cylinders, but it is also assumed that they will be linked together as described below. To be: 1. The first engagement is when the guide tube control cylinder 333 is at its most distal end. When the outer tube 102 is retracted and the guide tube 115 is fully deployed, Only then does it allow the needle control cylinder 345 to be unlocked. 2. The second linkage is the injection needle control cylinder 345 at its most distal end and the needle 11 9 is retracted into the guide tube 115, the guide tube control cylinder The combination of the above control mechanism with buttons 332 and 342 allows the unlocking of the button 333. This makes the use of the PTAC 100 reasonably simple and easy. When the user presses the button 332, the guide tube control cylinder 333 advances to The needle 115 expands outward, and when the button 342 is pressed, the needle 119 advances and penetrates the inner wall of the renal artery. An injection is performed and then pressing button 342 reverses the procedure, inserting needle 119. When the button 332 is pressed again, the guide tube control cylinder 333 moves to the proximal side. 2 to retract the guide tube 115 into the body of the PTAC 100.

[0130] By pressing the button, the handle is operated and each part is pushed or pulled vertically to guide it. The tube and needle are shown deployed in FIG. 11, but the locking or longitudinal movement is not shown. It is contemplated that other techniques, such as rotating mechanisms, may also be used. Fisch filed on October 23, 2012, which is incorporated by reference in its entirety. In U.S. Patent Application Serial No. 13 / 643,070 to Ell et al., such a rotation is shown in FIG. The locking mechanism is shown.

[0131] Flush the injection lumen with saline as described in step 8 of the method above. The advantage of filling the renal artery is that it prevents the inadvertent introduction of toxic cauterizing fluid into the renal artery during treatment. There are other techniques that have advantages, but are enabled by the low dead space PTAC 100. Specifically: If the dead space is small and the cautery fluid is ethanol, hypertonic saline, or hypotonic saline, Outside the patient's body, cauterizing fluid can be used to fill the dead space. To mix the samples, 0.5 mL of ethanol, hypertonic saline, or hypotonic saline was directly injected. This is why the flushing step after injecting the cauterizing solution is This reduces the number of injection steps during the treatment procedure from two to one per artery. For example, if the dead space is 0.1 mL and the amount of ethanol desired is 0.2 mL, then 0.1 mL The dead space can be filled outside the patient's body with 1 L of ethanol. The catheter and needle are then deployed into the first renal artery. 0.2 mL of additional ethanol is then injected. This results in 0.2 mL being delivered into the perivascular space and 0.1 mL remaining in the dead space. The needle 119 and the guide tube 115 are retracted, and the PTAC 100 is deployed in the other renal artery. Then, the needle 119 and the guide tube 115 are removed and another 0.2 mL of ethanol is injected. The ablation procedure is then performed by retracting the renal artery and removing the PTAC 100 from the patient's body. The amount of ethanol that leaks into the vein is very small (less than 0.05 mL), and even 10 times that amount can cause kidney damage. Another advantage of this reduced-step method is that only the cauterizing fluid enters the vascular system. Because the catheter is delivered into the surrounding space, the procedure described above requires that the catheter be delivered first before the cauterizing fluid is delivered. The advantage of this approach is that it reduces the "dilution" of the cauterizing solution by the saline solution.

[0132] In one variation of this procedure, before the PTAC 100 is placed within the patient's body, A cap 356 is secured over the fitting for the injection port 354, thereby allowing the PTAC 100 to be connected to the renal artery. Care should also be taken to prevent cauterizing fluid from entering the renal arteries during insertion into the vein. In addition, such a situation may occur when the PTAC 100 is transferred from one renal artery to the other. A port cap 356 is placed over the fitting for the injection port 354 to allow cautery fluid to enter the second renal artery. The lid 356 also prevents the PTAC 100 from entering the patient's body when the PTAC 100 is removed from the patient's body. The cap 356 is also secured onto the fitting for the injection port 354. During the renal denervation procedure, the cap 356 is baked off. The cautery fluid is removed only to be injected into the perivascular space of the vessel being treated.

[0133] The stopper attached to the injection port 354, when closed, also prevents the cauterizing fluid from entering the needle distal opening of FIGS. In practice, of course, the PTAC 100 may be placed in the patient's body to prevent leakage from the PTAC 100. When moving through the arterial system, if the lid 356 is not attached, the blood pressure in the arterial system , any liquid within the infusion lumen of the PTAC 100 will exit through the infusion port 354.

[0134] It is also possible to combine flushing steps with or without flushing steps. For example, PTAC 100 The dead space of the catheter can be pre-injected with cauterizing fluid, and the needle 119 and guide tube 115 can be deployed. After the injection, the cautery fluid can be flushed into the perivascular space with saline. After injection into the perivascular space, the needle 119 and guide tube 115 can be retracted out of the perivascular space. The dead space can then be refilled with cautery fluid and flushed out with saline. , other renal arteries can be treated.

[0135] The PTAC 100 is inserted into the fully extended guide tube 115 and the fully retracted injection tube 116. The guide tube can be packaged with the guide tube 116. The reason for this is that the guide tube is made of It is preferable that the device be made of a plastic such as a polyethylene terephthalate (PE) and molded into a curved shape. Such plastic material, when packed and retracted within the hollow shaft 120, 20. An infusion tube having a needle 119 at its distal end. The device can also be shipped with the guide tube 116 fully extended, allowing The shape of the tube 115 and the injection tube 116 is best maintained. In this case, the operator may To ensure no stings occur, the device is shipped in a protective container.

[0136] The handle 300 of FIG. 11 has a distal portion having a tapered protruding structure 338. A thin protruding structure 338 is attached to the hypotube 82, and the hypotube 82 is a PT It should also be understood that the AC 100 extends for most of its length. As shown, hypotube 82 is connected to tube 92, which is connected to the PT The hypotube is connected to the outer tube 102 of the AC 100. It is made of the same type of metal as the firing needle, typically stainless steel.

[0137] FIG. 12 illustrates a self-expanding guide supported by an intraluminal central placement mechanism (ICM) 250. FIG. 2 is a longitudinal cross-sectional view of another embodiment of a PTAC 200 having a tube 215; 50 aids in uniformity of expansion of the self-expanding guide tube 215 and further The central portion 204 of the ICM 250 opens against the inner wall of the target vessel. 2, providing a larger surface area for insertion of the distal end 229 of the guide tube 215 into the target vessel. The injection tube 216 with the distal injection needle 219 is pushed aside by the wall or into the target vessel. Prevents lateral movement as it advances through the inner wall of the tube. Similar to 00, the guide tube 215 is a needle guide element and is an injection needle having an injection needle 219. As tube 216 advances through the inner wall of the target vessel, it expands outwardly to form infusion tube 216. 16 at its distal end to support / back up the infusion needle 219. This support or back up is In comparison to the embodiment of the PTAC 50 shown in FIG. 1, the PTAC as shown in FIG. This is an important feature of another embodiment of the PTAC 200. The PTAC 200 shown in FIG. The support 220 has a distal portion 223, a distal tapered portion 226, and a radiopaque marker band 22 4. The distal side of the distal tapered portion 226 includes a core wire 211 and an outer layer 228. The guide wire 210 is fixed to the injection tube 216. Transparent wires 218 are used to connect the injection tubes so that their placement can be visualized under fluoroscopy. This increases the radiopacity of the tube 216.

[0138] The PTAC 200 of FIG. 12 has four guide tubes 216 along with four concentric injection tubes 216. The renal denervation needle has a tube 215. Ideally, three to five needles are used for renal denervation. When using ethanol as the cautery fluid for nerve cautery, three needles are sufficient. ethanol is hydrophilic, i.e., it diffuses easily into human tissues. It is.

[0139] The core wire 211 connects to the central portion of the PTAC 200 and extends distally to provide a fixed The fixed wire and the guidewire 210 are the center of the fixed wire and the guidewire. Forming is well known in the medical device field.

[0140] The ICM 250 includes a distal ring 202, a support strut 208, and a radiopaque marker 206. The ICM 250 includes a central portion 204 having a guide tube 215 during expansion. The guide tube 215 is additionally moved radially and The outside of the center 204 is also flat or slightly curved. 215 has a curved surface that engages or contacts the inner wall of the target vessel such that the distal end of the guide tube 215 This reduces trauma to the vessel wall compared to contacting the inner wall of the target vessel. The surface of the central portion 204 is adapted to contact the distal end of the guide tube 215 with the inner wall of the target vessel. Therefore, a larger surface area of ​​the guide tube 2 contacts the vessel wall. This reduces the likelihood that the distal end 229 of the catheter 15 will damage the inner wall of the target vessel.

[0141] As shown in FIGS. 12 and 13, a guide tube is attached to the distal side of the ICM 250. It is envisioned that there are several techniques for forming the structure of probe 215. One technique is to The first step is to use a Nitinol tube and form it into the shape shown in FIG. Once heat treated, the distal end 229 of the guide tube 215 can be machined to remove material. In a second machining step, half of the guide tube 215 is removed. and that part of the ICM 250 of the PTAC 200 is at approximately 90° to 270°. A radiopaque plug 206 is mounted within the horizontal portion 204 and the distal end of the ICM 250 is It is attached to the distal ring 202 .

[0142] In another technique, the guide tube 215 is made of plastic with a smooth wire made of Nitinol. The yar has three sections: a proximal section that attaches to a plastic guide tube; It has a flat central portion and a distal curved ICM portion.

[0143] FIG. 12 shows a self-expanding guide tube 215 that is adapted to be able to expand outward. The system has a radiopaque marker band 213 retracted to its proximal or open position. The radiopaque plug 206 is shown in the guide tube 215 in the target vein. Fluoroscopic visualization to confirm proper expansion near and / or in close proximity to the inner wall of the vessel The injection tube 216 having a distal injection needle 219 and a distal opening 217 allows The catheter advances through the guide tube 215 and penetrates the inner wall of the target vessel. The cautery fluid is then The needle is then inserted through the distal opening 217 into the perivascular space. 6 is retracted into the guide tube 215 and the sheath 212 is advanced distally to The tube 215 and the ICM 250 are folded and stored. The radiopaque marker band 213 is adjacent to the radiopaque marker band 224 on the support 220. When in contact with the PTAC 200, the practitioner can see that the PTAC 200 is in its retracted position and the guard The catheter is then retracted into the guide catheter.

[0144] FIG. 13 is an enlarged longitudinal cross-sectional view of region S13 of FIG. 12, showing the fully deployed PTAC 2 00 structure. Infusion tube 216 with distal infusion needle 219, needle distal opening 217, and a radiopaque wire 218 are attached to the gas turbine having an ICM 250. 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 tube 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] FIG. 14 is an enlarged vertical cross-sectional view of region S14 of PTAC 200 of FIG. Shown is a sheath 212 having a distal radiopaque marker band 213. 2, a catheter 215, an infusion tube 216, a radiopaque wire 218, and a core wire 219. 11 is also shown. The central and proximal portions of the PTAC 200 are shown in accordance with the prior art disclosures, U.S. Pat. See patent application Ser. Nos. 13 / 294,439 and 13 / 342,521. To do this, the practitioner extends the guide tube 215 outward toward the inner wall of the target vessel. The PTAC 200 includes a mechanism near the proximal end that allows 2, an injection needle 219 is inserted through the guide tube 215 into the inner wall of the target vessel. A mechanism for controlling the advancement of tube 216 is also included.

[0148] Fischell et al., in U.S. patent application Ser. No. 13 / 643,070, The tensile guide tube is released to place the injection needle deep within or outside the adventitia of the target vessel. Illustrated are several handle / proximal configurations specifically designed for advancement. Such a design works well in conjunction with the PTAC 200 of FIGS.

[0149] The PTAC 200 of Figures 12-14 shows a self-expanding guide tube structure. Add ICM to the manually expanded PTAC 100 in Figures 2-10 to create a vascular wall around the target vessel. Further support and back-up of the pointed guide tube is envisioned.

[0150] An important inventive feature of the present PTAC 200 is the needle guidance element / guide of Figs. Radial and lateral / circumferential support structures for tube 115 and guide tube 215 These include a hollow shaft 120 having an opening 131 and a guide tube 1 of FIG. 15 in the radial and lateral directions, and a central support 121 for supporting the guide tube 2 12 which provides radial and lateral support to the ICM 250 of FIG.

[0151] 15 is a longitudinal cross-sectional view of a PTAC 300, another embodiment of the present application. 300 is a single injection tube having a distal radiopaque marker 322 associated therewith. The guide tube 316 and the injection tube 318 are disposed within the tube assembly 315, and the distal opening 31 7 and the distal injection needle 319, and the visibility of the needle 319 under fluoroscopy. The PTAC 300 has gold plating on the outer surface of the fill tube 318 which enhances , a distal tapered protrusion 306, and an opening 331 through which the infusion tube assembly 315 advances. The housing 302 has an outer tube 302 .

[0152] The PTAC 300 also includes an inner tube 305 that communicates with the infusion lumen 333. The infusion lumen 333 is in fluid communication with the lumen of the infusion tube / guide tube assembly 315. The lumen of the infusion tube / guide tube assembly 315 is in fluid communication with the lumen of the infusion needle 319. The inner tube 305 is connected to the injection tube / guide tube via the connecting tube 325. 3 and 4. The central support 321 provides a slope 344 that supports the infusion tube assembly 315. It bends outwardly to radially support the penetration of the injection needle 319 into the inner wall of the target vessel.

[0153] The distal protrusion 345 of the central support 321 joins with the distal tapered protrusion 306. The probe 302, the distal tapered protrusion 306 or the central support 121 may also include a radiopaque marker. or may contain a radiopaque filler such as tungsten-filled polyurethane. The central support 321 may be made of a plastic containing a fluorine. It retracts completely into the body of the PTAC 300, allowing the PTAC 300 user to avoid needle stick injuries. The proximal extension must extend a sufficient distance so that the

[0154] Distal tapered protrusion 306 is preferably made of a relatively low durometer plastic or The injection needle 319 is made of flexible plastic. It is not made of any metal that will retain its shape. It is good to use cobalt chrome alloy such as L605 or shape memory alloy such as Nitinol. It is preferable that this is possible.

[0155] PTAC 300 has a distal fixed guidewire like PTAC 100 of FIG. Can be guided in either an over-the-wire or quick-change style It is also envisioned that the PTAC 10 of FIGS. 12-14 may be used as shown in other embodiments disclosed herein. Instead of a fixed guidewire 211 like this, a tapered protrusion 306 similar to that of FIG. A flexible tapered protrusion may be used.

[0156] The PTAC 300 has a faster needle delivery speed than the PTAC 100 shown in Figs. The advantage of this is that it requires one less step. The distal end of the PTAC 300 is then Once in place, the practitioner can then use a mechanism on the proximal end of the PTAC 300 to tighten the inner tube 30. 5 can be advanced relative to the outer tube 302. This allows the injection tube When the block assembly 315 advances and is bent by the inclination 344 of the central support portion 321, the block assembly 315 The needle 319 penetrates the inner wall of the target vessel and exits through the opening 331 into the outer tube 302. 315 is inserted into the catheter and the penetration is limited by the distal end of the injection tube / guide tube assembly 315. A distal radiopaque marker band 32 on the infusion tube / guide tube assembly 315 2 in combination with the gold plating on the needle 319 to deliver cauterizing fluid into the perivascular space. This allows the practitioner to visualize the deployment of the PTAC 300.

[0157] In this embodiment of the PTAC 300, the injection tube / guide tube assembly 31 5 expands outwardly to deflect the infusion needle 319 as it advances through the inner wall of the target vessel. 19 is a needle guiding element that supports / backs up the needle.

[0158] FIG. 16 is a longitudinal cross-sectional view of a distal portion of yet another embodiment of a PTAC 400 disclosed herein. In this embodiment, the four guide tubes 415 are expanded outward to guide the target vessel. An inflatable balloon 450 is used that engages the inner wall of the tube. Two to eight guide tubes are envisioned, with three for delivery of ethanol for renal denervation. A guide tube of is preferred.

[0159] The PTAC 400 includes an outer layer 425 and a distally attached and secured guidewire. 16 shows a distal radial 420, a core wire 411, and a distal tip 428. With the guide tube 415 having a radiopaque marker 422, PTAC 400 in a 3D position. Note that coaxially within guide tube 415 is the distal end 429 of the inlet tube 416, the pointed distal infusion needle 419, and the guide tube 415 A distal opening 417 is disposed outward beyond the distal end of the catheter 410. A radiopaque wire 418 is disposed It is within the lumen of the infusion tube 416 for dead space reduction and increased visibility.

[0160] The distal portion of the PTAC 400 includes a tapered portion 426, a radiopaque marker band 424, and The tapered portion, including elements 423, 424, and 426, has a proximal portion 423. The occlusion 430 is referred to as an occlusion 430. The occlusion 430 comprises a distal tip 428, an outer layer 425, and a core wire 436. The catheter is attached to a fixed guidewire 420 having a guidewire 411. Another important feature of the embodiment is the radiopaque marker band 413 on the sheath 402. The radiopaque marker band 413 indicates that the PTAC 400 is in its retracted position. , the sheath 402 is at the most distal portion, so that the guide tube 415 and the injection tube The occlusion 430 is provided with a slit 440 for the surgeon to easily determine whether the occlusion 430 is fully deflated. 424 in combination with the radiopaque marker band 424 to define a distal portion of the sheath 402 relative to the occlusion 430. The position of the distal end of the infusion tube 416 with the distal infusion needle 419 is advanced into the target vessel. The guide tube 415 maintains its position relative to the inner wall of the target vessel as it penetrates the wall. Thus, the preformed radius of curvature of the injection tube 416 is in accordance with the curvature of the guide tube 415. Specifically, the radius of curvature of the central axis of the distal portion of the infusion tube 416 should be similar to the radius of curvature of the central axis of the distal portion of the infusion tube 416. The diameter should be approximately the same as the radius of curvature of the central axis of the guide tube 415. The radius of curvature of the central axis of the tube 415 and the injection tube 416 is within 1 mm. Ideally, they should be within 0.2 mm of each other. The shape of the guide tube 415 and the injection tube 416 are shown in FIG. The shape may consist of two or more sections, each having a different radius of curvature. Even if these sections have two or more radii of curvature, The curved shape of the injection tube 416 when the injection tube 416 is inserted is shown in FIG. It is important that the axis of the advanced injection tube 4 is coaxial with the longitudinal axis of the 16 must fit completely within the advanced guide tube 415. If significantly different, the radius of curvature of the injection tube 416 may be greater than the radius of curvature of the guide tube 415. This is because as the injection tube 416 advances, 416 to prevent the guide tube 415 from being pushed away from the inner wall of the target vessel. These two radius of curvature features should both be within 20% of each other, ideally The maximum allowable limit for this should be 5%.

[0161] Similar to the PTAC 100 of FIGS. 2-11, the guide tube 415 is a needle directing element. 419 is then extended outwardly to allow the injection tube 416 with the injection needle 419 to pass through the inner wall of the target vessel. 416. The distal end of the infusion tube 416 supports / backs up the infusion needle 419 as it advances. .

[0162] FIG. 16 shows a catheter attached at its proximal end to inner tube 405 and at its distal end to occlusion 430. 3. The inflatable balloon 450 is shown with side holes 452 in the inner tube 405. The inflation lumen 433 of the inner tube 405 and the interior space 454 of the inflatable balloon 450 This provides fluid communication between the INAS 50 shown in FIG. , the radial stability of the guide tube 415 is significantly improved. This is to firmly support the guide tube 415 in the radial direction. The outer side may be fixedly connected to each guide tube 415. In this configuration, the guide A balloon 450 connected to the tube 415 uniformly expands the guide tube 415. 3. To improve centering of the distal portion of the PTAC 400, the guide tube 415 is tensioned. Improves lateral stability.

[0163] The PTAC 400 and guide tube 415 can be advanced in the same manner as in the previous embodiment. Alternatively, the PTAC 400 and guide tube 415 may be retracted into the inner tube. 405, only the injection tube 416 is connected longitudinally within the lumen of the guide tube 415. It may be movable to.

[0164] As with the above embodiment, the PTAC 400 is adapted to be advanced over a single guidewire. Alternatively, the PTAC 400 can be configured to not require a guidewire at all. Also, similar to the PTAC 300 in FIG. 15, the guide tube 415 and the injection tube Tube 416 can be combined.

[0165] For the configuration shown in FIG. 16, a sheath having a distal radiopaque marker band 413 402 is pulled back to allow the guide tube 415 to expand outward. Radiopaque wire 418 and radiopaque marker bands 422, 424, and 413 The magnet 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 genus.

[0166] The balloon 450 may be compliant, semi-compliant, or non-compliant, although a flexible, compliant balloon is preferred. This is preferable because the expansion pressure of the balloon 450 can be varied. This is because the diameter of the guide tube 415 can be easily set. By connecting it to the outside of the balloon, the guide tube 415 is placed inside the balloon. This simplifies the structure. The balloon 450 is then allowed to engage the inner wall of the vessel such that the entirety of the balloon 450 contacts the inner wall of the target vessel. When the balloon 450 contacts the inner wall of the target vessel, some epithelial cells are shed. This can lead to undesirable neoepithelial hyperplasia. Inflate with saline injection via 3 to an inflation pressure of 10 to 100 psi.

[0167] FIG. 16 illustrates an inflatable balloon providing radial and lateral support to the guide tube 415. 450, but may be implemented using some mechanical structure that is expandable under the guide tube 415. Such a structure may be used without actually connecting to the guide tube. For example, a structure similar to a car jack that releases when the ends meet can be used. It can be a thread or just a wire or tube that is pulled together at the ends. A structure can be formed to support the guide tube 415 .

[0168] 12. An inflatable balloon, such as balloon 450 of FIG. 16, can be mounted on an intraluminal central placement mechanism (I It is also envisaged that the PTAC 200 with ICM 250 will be added to the existing PTAC 200 with ICM 250. If the guide tube 215 is self-expanding or manually expandable, is applicable.

[0169] FIG. 17 is a schematic diagram of the central support 121 of the PTAC 100 of FIGS. Distal tip 145 having 46 corresponds to the distal tip of PTAC 100 as shown in FIGS. The curved, angled portion 144 is connected to the proximal portion of the end 106. The distal finger 1 provides radial and lateral support as it moves outward along the curved ramp 144. 42 has an inclined inner surface 148, which also The curved structure 142 (shown in FIG. 4) supports the outer chuck laterally as it advances. It connects to the inside of the tube extension 104 .

[0170] FIG. 18 shows a longitudinal cross section of the three central portions of the PTAC 100 of FIGS. At the proximal end of the AC 100 core are three concentric metal hypotubes: the outer hypotube There is a hypotube 82, an intermediate hypotube 83, and an inner hypotube 85. These can be made of stainless steel, L605, cobalt chrome alloys, or thin metals such as Nitinol. The outer hypotube 82 of the PTAC 100 is made of a solid metal tube having a distal end The proximal end of the catheter is connected to a plastic outer tube 92, which generally comprises: It is made of a relatively high durometer plastic, such as polyimide. As can be seen from the central cross-sectional view of FIG. 1, the proximal plastic outer tube 92 is 2-11. Tube 102 has a lower durometer / harder than the proximal plastic tube 92. It is made of flexible plastic.

[0171] As shown in the proximal portion of FIG. 18, the intermediate hypotube 83 is connected at its distal end to the intermediate tube. 18. As shown in the center of FIG. 18, the central infusion lumen 93 is connected to a probe 103. At its distal end it connects to the proximal end of inner tube 105 which has an infusion lumen 133 .

[0172] Also shown in the distal portion of FIG. 18 is a connecting tube 125, which is The inner tube 105 is then inserted into the injection tube 104 of FIGS. A radiopaque wire 118 runs the entire length of the infusion tube 116. Visualize under fluoroscopy. The connecting tube 125 is attached to the inner tube 105 proximal to its distal end. The proximal end of the inner tube 105 is also coaxial with the outer tube 102. The outer tube 102 is coaxially disposed within the outer tube 102 shown in FIGS. It is proximal to the extension 104.

[0173] FIG. 19 is a schematic diagram of the distal end of the fully expanded PTAC 100 of FIGS. The orientation of the sharpened infusion needle 119 relative to the distal end of the PTAC 100 is shown. 1 is a view of the longitudinal axis of the PTAC 100 as viewed from its distal end. The tip and tapered distal portion 106 are clearly visible and have radiopaque markers 122 Also clearly visible are the three extended guide tubes 115, each having a distal injection needle 119. The expanded injection tube 116 is shown with the cut portion of the needle 119. The open surface of the needle 119 delivers cauterizing fluid perpendicular to the longitudinal axis of the PTAC 100. The needle 119 is cut so that the beveled cut surface is oriented transversely to the axis of the needle 119 .

[0174] When the needle 119 advances, the tip of the needle 119 gets caught on the inside of the guide tube 115. This configuration is beneficial because it is less susceptible to breakage. The triple cut needle 119 is clearly shown to be hooked on the inside of the guide tube 115. Further reducing the possibility.

[0175] FIG. 20 is an enlarged schematic view of section S20 of FIG. 19, showing the sharpened injection needle 119. FIG. 20 shows a preferred shape of the needle distal opening perpendicular to the longitudinal axis of the PTAC 100. 117. The flow direction of cauterizing fluid from portion 117 is shown. The additional cut 91 is also shown. The direction of the main cut of the needle 119, as well as the additional cut 91 The combination of these orientations causes the needle 119 to move in a guide tube 115 as it advances through the guide tube. This reduces the possibility of accidentally getting caught inside the guide tube 115.

[0176] FIG. 21A is a schematic diagram of another embodiment, the PTAC 500. The occlusion 520 uses the proximal portion of the occlusion 520 as a support structure for the guide tube 515. 20 has a proximal portion 523, a radiopaque marker band 524, and a distal tapered portion 506. Proximal portion 523 includes a slot 525 within which guide tube 515 nests. The outer tube 502 forms the outside of the PTAC 500 and includes an occlusion 520. The inner tube functions as a sheath that is advanced over the proximal portion 523 of the catheter to form a seal. 505 is a structure of the outer tube 502 that provides the impetus for the movement of the needle 519 (not shown). The wire 503 provides the impetus for the movement of the guide tube 515. The core wire 511 is connected to the occlusion portion 520, and the PTAC 50 The mechanism at the proximal end of the closure 502 may be configured to occlude the outer tube 502 and / or the guide tube 515. The PTAC 500 is delivered over a guidewire to facilitate longitudinal movement of the catheter 520. or, as in PTAC 300 of FIG. 15, the distal end of the In some cases, the catheter does not have a guide wire, in which case a fixed guide wire 509 is used. is shown.

[0177] FIG. 21A shows the PTAC with the guide tube 515 advanced but before the needle 519 is advanced. 500. The guide tube 515 is shown in FIG. PTAC 50 of FIG. 1. Tube 502 acts as a sheath and is pulled back to encase guide tube 515. The next step after the placement of FIG. 21A is to Proximal movement of core wire 511 is actuated by a mechanism within the proximal portion of TAC 500. The obstruction portion 520 moves proximally (is pulled back) by the force of the thrust. The support 525 enters the expanded guide tube 515 and forms the central support 1 shown in FIG. Similar to 21, slot 525 moves proximally until it provides radial and lateral support. As the occlusion 520 is pulled back, the needle 519 penetrates the inner wall of the target vessel in the configuration shown in FIG. Move forward inward.

[0178] FIG. 21B shows the needle 519 at the distal end of the injection tube 516 after advancement into the inner wall of the target vessel. 5 shows the placement of the PTAC 500. The occlusion 520 prevents the ventricle from entering the ventricle as the needle 519 advances. The guide tube 515 is radially supported to prevent it from being pushed back against the inner wall of the pipe. The slot 525 also ensures that the guide tube 515 and needle 519 are positioned 120 degrees from each other. The catheter is supported laterally so that the cauterizing fluid is uniformly injected inside or outside the inner wall of the target vessel. As in the previous embodiment, guide tube 515 is the needle directing element. Thus, the occlusion 520 radially and laterally supports the needle guiding element, the guide tube 515. It is a vertically movable mechanism that holds the

[0179] While this specification has focused on the use of PTAC in tissue ablation applications, the devices of FIGS. The device and method may be used to deliver blood to specific portions of blood vessels or into many tissues just outside of blood vessels or into the prostate. Any liquid for any purpose, including localized drug delivery into prostatic tissue via the gland. Systemic injection applications are expressly envisioned.

[0180] Although three or four injection needles are shown in the embodiment shown in FIGS. The needle guide element is radially and / or laterally supported to guide the needle as it penetrates the inner wall of the target vessel. The structures disclosed herein, including the mechanism for holding the needle, may be used with one needle, two needles, or five or more needles. Even for single needle designs, Mercato Smaller diameter and easier to use than other single needle systems such as the Bullfrog system from r .

[0181] Obviously, numerous other modifications, adaptations, and alternative designs are possible in light of the above teachings. Therefore, within the scope of the appended claims, it is to be understood that the invention is not limited to the disclosed embodiments. It should be understood that the present invention can be practiced in any manner.

Claims

1. a catheter body having a longitudinally extending central axis; at least two guide tubes adapted for outward advancement toward the luminal surface of the target vessel; at least two injection tubes with injection needles adapted for outward advancement; Equipped with the at least two guide tubes have distal ends that engage an inner wall of the luminal surface of the target vessel, the at least two injection tubes with the injection needles do not penetrate the inner wall of the luminal surface when penetrating the inner wall of the luminal surface of the target vessel, and the at least two injection tubes with the injection needles extend to a predetermined depth beyond the distal ends of the at least two guide tubes when the at least two guide tubes engage and do not penetrate the inner wall of the luminal surface. catheter.

2. The catheter of claim 1 , wherein at least two infusion tubes having the infusion needles are advanced simultaneously.

3. The catheter of claim 1 , wherein at least two infusion tubes having the infusion needles are retracted simultaneously.

4. The catheter of claim 1 , further comprising a guide tube control mechanism configured to control distal and proximal movement of the at least two guide tubes.

5. The catheter of claim 1 , further comprising an injection needle control mechanism configured to control distal and proximal movement of at least two injection tubes having the injection needles.

6. The catheter of claim 1 , wherein the distal ends of the at least two guide tubes engage an inner wall of the luminal surface of the target vessel to center a distal portion of the catheter body within the target vessel.

7. The catheter of claim 1 , wherein the distal ends of the at least two guide tubes engage an inner wall of the luminal surface of the target vessel to uniformly deploy the injection needle across the inner wall of the luminal surface of the target vessel.

8. The catheter of claim 1 , wherein distal portions of the at least two guide tubes include radiopaque markers for visually verifying centering of the at least two guide tubes.

9. The catheter of claim 1 , wherein when the distal ends of the at least two guide tubes engage an inner wall of the luminal surface of the target vessel, a plane of the distal ends of the at least two guide tubes is parallel to a central axis of the catheter body.

10. The catheter of claim 1 , wherein the at least two injection tubes having injection needles are configured to penetrate an internal elastic layer of the target vessel.

11. The catheter of claim 1 , wherein the at least two injection tubes having injection needles are configured to penetrate the media of the target vessel.

12. The catheter of claim 1 , wherein the at least two injection tubes with injection needles are configured to be positioned to deliver an ablation fluid to the adventitial surface or outside the adventitial surface of the target vessel.

13. The catheter of claim 1, wherein the at least two injection tubes with injection needles are advanced 0.5-4 mm beyond the internal elastic layer of the target vessel.

14. The catheter of claim 1 , wherein the depth adjustment means is not accessible to the user.

15. The catheter of claim 1 , wherein the at least two injection tubes having injection needles include a preset curved shape having a radius of curvature similar to a radius of curvature of the at least two guide tubes.

16. The catheter of claim 1 , wherein the at least two guide tubes comprise an inner layer and an outer layer.

17. The catheter of claim 1 , wherein a distal portion of the catheter body comprises at least two openings through which the at least two guide tubes are configured to advance.

18. The catheter of claim 1 , wherein the catheter is configured to be placed in a renal artery for denervation.

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