Perivascular tissue access catheter with locking handle

Abstract

An intravascular catheter for perivascular and / or periurethral tissue ablation includes multiple penetrators advanced through a supported guide tube that expands about a central axis to engage the interior surface of the wall of a renal artery or other blood vessel in a human body, allowing ablation by injection of ablation fluid, neural sensing, neural stimulation, or application of energy to ablate the tissue. The catheter may include a proximal handle for advancement of the guide tubes and penetrators.

Description

Technical Field

[0001] Some aspects of the present invention are applicable to the field of devices for advancing a needle-like structure for sensing neural activity, tissue resection, or injecting fluid into a mass of tissue outside the inner wall of a target blood vessel in a human body. Applications include the treatment of hypertension, congestive heart failure, BPH and prostate cancer, PCI, and the prevention of restenosis after other diseases.

Background Art

[0002] Fischell et al. describe in Patent Document 1 an intravascular fluid injection catheter with a proximal handle having a gap between two components of the handle and an adjustment tool configured to adjust the gap. The gap can be used to limit the penetration depth beyond the guide tube of the injection tube with a distal needle that expands outwardly against the wall of the target blood vessel. This handle is effective but may lack a locking mechanism to prevent movement of the guide tube or injection tube. Patent Document 1 is hereby incorporated by reference in its entirety.

[0003] In Patent Documents 2, Patent Document 3, Patent Document 4, Patent Document 5, Patent Document 6, Patent Document 7, and Patent Document 8, all of which are hereby incorporated by reference in their entirety, Fischell et al. show in FIG. 11 an improved handle with a separate unlocking mechanism for the movement of the guide tube and the injection tube with a distal needle. Similar handles are shown by Fischell et al. in Patent Documents 9 and Patent Document 10, all of which are hereby incorporated by reference in their entirety, and can be used to advance an electrode into and further beyond the inner wall of a target blood vessel for neural sensing, electrical stimulation, and energy-based tissue resection.

[0004] The patents for both sets mentioned earlier use a needle guide element in the form of a guide tube to support the advancement and penetration of a needle / wire with a sharp distal end into the inner wall of a target vessel. Such a structure may be important in some cases for use in blood vessels, as it allows for the use of small-diameter needles / wires that can avoid causing blood loss when retracted.

[0005] Throughout this specification, the terms fluid or solution are used interchangeably to include any liquid or gaseous substance delivered to a mass of tissue in the human body with the intention of administering, damaging, causing death to, or excising nerves or tissue within that mass.

[0006] Furthermore, throughout this specification, the terms "internal wall" or "internal surface" applied to blood vessels, vessel walls, arteries, or arterial walls mean the same thing as the internal surface of a vessel wall whose inner side is the lumen of the vessel. Also, the term "injection port" is defined as the distal opening in a needle from which the injected fluid exits. With respect to injection needles, the terms "injection port" or "distal opening" may be used interchangeably in this specification.

[0007] The term "deep into structure" is defined as "beyond structure" or "outside of structure," as in "deep into the inner wall of the target vessel," which refers to the mass of tissue outside the inner surface of the vessel. [Prior art documents] [Patent Documents]

[0008] [Patent Document 1] U.S. Patent No. 9,056,185 [Patent Document 2] U.S. Patent No. 9,179,962 [Patent Document 3] U.S. Patent No. 9,254,360 [Patent Document 4] U.S. Patent No. 9,301,795 [Patent Document 5] U.S. Patent No. 9,320,850 [Patent Document 6] U.S. Patent No. 9,526,827 [Patent Document 7] U.S. Patent No. 9,539,047 [Patent Document 8] U.S. Patent No. 9,554,849 [Patent Document 9] U.S. Patent No. 9,931,046 [Patent Document 10] U.S. Patent No. 9,949,652 [Overview of the project] [Means for solving the problem]

[0009] The use of guide tubes as needle guide elements for catheters such as perivascular tissue ablation catheters (PTACs) described in Patent Documents 1, 2, 3, 4, 5, 6, 7, and 8 may be utilized or modified for use with systems and methods such as those disclosed herein. Such guide elements may be important in some cases for supporting small-diameter needles to access tissue masses deep into the inner wall of target vessels.

[0010] Some embodiments of the handle features disclosed herein may be used or modified for use with embodiments of sympathetic nerve sensing catheters (SNSCs) and perivascular nerve sensing and ablation catheters (PNASCs) described by Fischell et al. in Patent Documents 9 and 10, which include similar guide tube / needle structures for placing needles and / or electrodes deep into the inner wall of a target vessel.

[0011] Although not included in any of the above applications, prototype handles using rings with pin and slot mechanisms were considered. While such handles can be used in some embodiments, they may be difficult to use in some embodiments, as they make it difficult to understand the visual confirmation of the pin locations to see where the guide tube or injection tube is positioned.

[0012] Some embodiments of the catheter may feature an improved handle that significantly simplifies the catheter's operation, allowing a single slider in the handle to continuously advance and retract the guide tube and needle (or electrode, or other peripheral effector) from a pre-deployment state to where the guide tube is deployed, where the needle extends beyond the distal end of the guide tube to a desired mass of tissue, and back. A single release mechanism, which may take the form of a button or other control, can ensure that the system re-locks itself under normal operation after each step.

[0013] The handle itself may have one or more additional physical characteristics. These characteristics may include any number of the following: • Ergonomic shape with finger rests to help position the user's hands correctly for steering. • Marking lines or other indicators to easily identify the position of the guide tube and needle / electrode associated with the slider position. • Visible icons on the handle surface to further confirm the position of the guide tube and needle / electrode associated with the slider position. • An optional special high-speed retraction mode in which both hands are used, and the needle and guide tube can be completely retracted with a single movement of the slider. • Add a disabling mechanism to re-lock the device in case it is accidentally disengaged.

[0014] Similar to other handles referenced in the patent of Fischell et al., some embodiments of the present invention may include a fluid injection port and one or more flushing ports for flushing air out of the catheter lumen by injection of saline solution. As described in Patent Document 5, the handle may use a non-standard connector on the injection port to prevent accidental injection of the injectable fluid into the flushing port.

[0015] Throughout this specification, the term "injection tube with distal injection needle" may be used to specify a tube with a sharp distal end used to penetrate tissue and inject fluid into that tissue. Such a structure may be called a subcutaneous injection needle, an injection needle, or simply a needle. The terms "element" and "structure" may also be used interchangeably within the scope of this application. The term "Luer fitting" may be used throughout this application to mean a tapered Luer fitting without a screw cap, or a Luer lock fitting with a screw cap.

[0016] These and other features and advantages of embodiments of the present invention will become clear to those skilled in the art by reading the detailed description, including the relevant drawings and claims.

[0017] In some embodiments, a catheter is provided for fluid delivery to a mass of tissue outside the inner wall of a target lumen, such as a blood vessel in a human body. In some embodiments, the catheter may comprise a catheter body having a longitudinally extending central axis. The catheter may comprise a distal portion having at least one guide tube having a distal end, the at least one guide tube being expandable between a first position within the catheter body and a second position that is angled away from the catheter body by a distal end proximate to the inner wall of the target blood vessel. In some embodiments, the catheter may comprise at least one sharp needle having an injection lumen with a distal injection outlet, with a portion of the at least one injection tube coaxially positioned inside the at least one guide tube. In some embodiments, the catheter may comprise a proximal handle having a top surface, two side surfaces, and a bottom surface adapted to advance and retract the guide tube and the needle. In some embodiments, the handle may comprise a release mechanism having a locked state and an unlocked state. In some embodiments, the handle comprises a movement mechanism configured to permit relative longitudinal movement of at least one guide tube relative to the catheter body and relative longitudinal movement of at least one needle relative to the at least one guide tube, the movement being dependent on the release mechanism being in the unlocked state and the movement being prevented when the release mechanism is not in the unlocked state.

[0018] In some embodiments, the catheter may comprise three guide tubes and three sharp needles. In some embodiments, at least one needle is hollow and has a fluid outlet near the distal end of the needle, and the catheter may have an injection lumen that is in fluid communication with the fluid outlet of at least one needle. In some embodiments, at least one needle has a distal end that forms an electrode. In some embodiments, the catheter body further comprises a wire extending the length of the catheter for transmitting an electrical signal between at least one electrode and a connector near the proximal end of the catheter. In some embodiments, the connector is adapted to connect the wire to an external device. In some embodiments, the external device comprises an electronic system selected from the group of sensors configured to measure an electrical signal, sensors for measuring an electrical signal sensed by the electrode of at least one needle, signal generators configured to provide an electrical stimulation signal to the electrode of at least one needle, or energy delivery effectors for providing energy-based excision through the electrode of at least one needle. In some embodiments, the proximal handle includes at least one marking line associated with a position of the movement function indicating a catheter state selected from the group of: a position of the movement mechanism where both at least one guide tube and at least one injection tube are retracted; a position of the movement mechanism where at least one guide tube is advanced but at least one injection tube is retracted; or a position of the movement mechanism where both at least one guide tube and at least one injection tube are advanced. In some embodiments, the proximal handle includes two or more marking lines. In some embodiments, the proximal handle may include a first marking line indicating a position of the movement mechanism where both at least one guide tube and at least one injection tube are retracted; a second marking line indicating a position of the movement mechanism where at least one guide tube is advanced but at least one injection tube is retracted; and a third marking line indicating a position of the movement mechanism where both at least one guide tube and at least one injection tube are advanced.In some embodiments, the proximal handle includes at least one icon associated with a catheter state selected from the group of: a position of the moving mechanism where both at least one guide tube and at least one infusion tube are retracted; a position of the moving mechanism where at least one guide tube is advanced but at least one infusion tube is retracted; or a position of the moving mechanism where both at least one guide tube and at least one infusion tube are advanced. In some embodiments, the proximal handle includes a first icon indicating a position of the moving mechanism where both at least one guide tube and at least one infusion tube are retracted; a second icon indicating a position of the moving mechanism where at least one guide tube is advanced but at least one infusion tube is retracted; and a third icon indicating a position of the moving mechanism where both at least one guide tube and at least one infusion tube are advanced. In some embodiments, the proximal handle includes two of each of the three icons. In some embodiments, the handle includes at least one flushing port. In some embodiments, the handle includes a finger rest to help position the operator's hand when operating the handle. In some embodiments, the moving mechanism is a slide switch. In some embodiments, there is at least one marking line on the top surface of the handle. In some embodiments, there are at least two marking lines on the top surface of the handle. In some embodiments, at least one icon is placed in a location selected from the top surface of the handle, one of the sides of the handle, both sides of the handle, or a chamfered or beveled surface between the top surface and the side of the handle.

[0019] In some embodiments, a method is provided for delivering fluid to the outside of the inner wall of a target blood vessel in a person's body. In some embodiments, the method may include advancing a catheter into the blood vessel. In some embodiments, the catheter may comprise a catheter body, a fluid injection lumen, a proximal handle with a locking release mechanism, a longitudinal movement mechanism, and a distal portion comprising at least one guide tube having a distal end, and at least one injection tube with a distal needle coaxially positioned within the at least one guide tube. In some embodiments, at least one guide tube is extendable away from the catheter body. In some embodiments, the injection tube is extendable beyond the distal end of at least one guide tube. In some embodiments, the distal needle of at least one injection tube has a fluid outlet that is in fluid communication with the catheter fluid injection lumen. In some embodiments, the method may include the step of activating the locking release mechanism in the handle. In some embodiments, the method may include the step of activating the longitudinal movement mechanism to advance at least one guide tube away from the catheter body by a predetermined distance until the distal end of at least one guide tube is close to the inner wall of the blood vessel. In some embodiments, the release mechanism is deactivated when at least one guide tube has been advanced by a predetermined distance. In some embodiments, the method may include the step of reactivating the release mechanism. In some embodiments, the method may include the step of operating a longitudinal movement mechanism to extend at least one injection tube by a predetermined distance beyond the distal end of at least one guide tube, so that at least one injection tube penetrates the inner wall of the target vessel and positions the fluid outlet of at least one needle into the tissue mass outside the inner wall of the target vessel. In some embodiments, the method may include the step of attaching a fluid source to the catheter. In some embodiments, the method may include the step of injecting fluid through the injection lumen of the catheter outwards from the fluid outlet of the needle into the tissue mass outside the inner wall of the vessel.

[0020] In some embodiments, the distal portion of the catheter comprises three guide tubes and three injection tubes with distal needles. In some embodiments, the method may include the step of reactivating the unlocking mechanism. In some embodiments, the method may include the step of operating the longitudinal movement mechanism to retract at least one injection tube into at least one guide tube and deactivating the unlocking mechanism. In some embodiments, the method may include the step of reactivating the unlocking mechanism. In some embodiments, the method may include the step of operating the longitudinal movement mechanism to retract at least one guide tube into the catheter body together with the retracted injection tube and deactivating the unlocking mechanism.

Brief Description of the Drawings

[0021] [Figure 1] A longitudinal cross-sectional view in the open position of the distal portion of a prior art PTAC shown in FIG. 3 of Patent Documents 2, 3, 4, 5, 6, 7, and 8 of Fischell et al., configured for delivery of fluid to a mass of tissue outside the inner wall of a target blood vessel. [Figure 2] A side view of an embodiment of a proximal handle designed for use with the PTAC of FIG. 1, for example. [Figure 3] An enlarged view of region 223 of FIG. 2. [Figure 4] A top view of the handle. [Figure 5A] A diagram showing non-limiting steps in a method of using handle 200 to deploy and retract a guide tube and an injection tube with a needle of the PTAC of FIG. 1. [Figure 5B] A diagram showing non-limiting steps in a method of using handle 200 to deploy and retract a guide tube and an injection tube with a needle of the PTAC of FIG. 1. [Figure 5C] A diagram showing non-limiting steps in a method of using handle 200 to deploy and retract a guide tube and an injection tube with a needle of the PTAC of FIG. 1. [Figure 5D]This figure shows non-limiting steps in a method of using the handle 200 to extend and retract the guide tube and the injection tube with the PTAC needle shown in Figure 1. [Figure 5E] This figure shows non-limiting steps in a method of using the handle 200 to extend and retract the guide tube and the injection tube with the PTAC needle shown in Figure 1. [Figure 5F] This figure shows non-limiting steps in a method of using the handle 200 to extend and retract the guide tube and the injection tube with the PTAC needle shown in Figure 1. [Figure 5G] This figure shows non-limiting steps in a method of using the handle 200 to extend and retract the guide tube and the injection tube with the PTAC needle shown in Figure 1. [Figure 5H] This figure shows non-limiting steps in a method of using the handle 200 to extend and retract the guide tube and the injection tube with the PTAC needle shown in Figure 1. [Figure 5I] This figure shows non-limiting steps in a method of using the handle 200 to extend and retract the guide tube and the injection tube with the PTAC needle shown in Figure 1. [Figure 6] This is a longitudinal cross-sectional view of the distal portion of the prior art SNSC / PNASC10, as shown in Figure 2 of Patent Documents 9 and 10. [Figure 7] Figure 6 is a side view of an embodiment of the proximal handle designed for use with SNSC / PNASC. [Modes for carrying out the invention]

[0022] Figure 1 is a longitudinal cross-sectional view of the distal portion of the perivascular tissue resection catheter PTAC100, as shown in Figure 3 of Fischell et al.'s Patent Documents 2, 3, 4, 5, 6, 7, and 8.

[0023] Figure 1 is a longitudinal cross-sectional view of the expanded distal portion. Figure 1 shows the fully open position, with the guide tube 115 accompanied by a coaxial infusion tube 116, which has a sharp distal infusion needle 119 and a distal opening 117 of the needle, which is the infusion outlet that extends outward beyond the distal end of the guide tube 115. It should be understood that there can be any number of infusion tubes and guide tubes. The guide tube 115 is a guide element that helps support the thin, flexible infusion tube 116. In some embodiments, the infusion tube comprises an infusion needle. In some embodiments, the infusion tube comprises an electrode. In some embodiments, the infusion tube is supported as it is advanced into the wall of the target vessel.

[0024] In some embodiments, to provide better visualization of the deployment using standard fluoroscopy, portions of the injection tube 116 and / or the guide tube 115 may be marked with a radiopaque material such as gold or tantalum, or a piece of radiopaque material may be used to form or be positioned within the injection tube 116 or the sharp needle 119. Figure 1 shows a radiopaque wire positioned within the injection tube 116 so that fluoroscopy can be used by the operator to clearly locate the injection tube 116. The material for the radiopaque wire can be selected from well-known radiopaque metals such as platinum, tantalum, gold, or alloys of such metals.

[0025] Figure 1 also shows a memory configuration for a fully open guide tube 115. The pre-formed radius of curvature of the injection tube 116 may correspond to the radius of curvature of the guide tube 115 so that the guide tube 115 maintains its position in contact with the inner wall of the target vessel when the injection tube 116 is advanced coaxially through the guide tube 115 to penetrate the wall of the target vessel.

[0026] Referring still to Figure 1, also shown are the outer tube 102 and the outer tube extension 104 having a distal opening 131 through which the guide tube 115, with radiopaque markers 122, is advanced outward from the body of the PTAC 100. Also shown are the tapered section 106 and the fixed guide wire 110 with a distal tip 109. The injection tube 116, with the distal injection needle 119 and the distal opening 117 of the needle, is shown in its fully extended position. The opening 131 supports the side of the guide tube 115 as the guide tube 115 is advanced outward before the injection tube 116 with the distal injection needle 119 advances. The PTAC 100 in Figure 1 has three guide tubes, with a third tube hidden behind the catheter, which is not visible in this schematic diagram. While the PTAC100 in Figure 1 has three guide tubes 115, other embodiments may have only one guide tube, as many as eight guide tubes, or more guide tubes, ranging from two, three, four, five, six, seven, eight, or any two of the above possible values. For target vessels of larger diameter, the use of four to eight or more guide tubes 115 and injection tubes 116 may be proposed.

[0027] Different shapes are conceivable for the distal opening (or window) 131 in the outer tube extension 104 from which the guide tube 115 exits. These possible shapes include a racetrack-type design with axially curved (e.g., rounded) proximal and distal ends and straight sides, as well as an elliptical or rounded shape. In some cases, a movable flap covering the opening 131 or slit may be made to smooth the outer surface of the PTAC for better delivery to the desired target lumen, such as the renal artery.

[0028] The proximal end of Figure 1 shows three concentric tubes, namely the outer tube 102, the middle tube 103, and the inner tube 105, which form the central portion and most of the length of the PTAC 100. The outer tube 102 is attached to an outer tube extension 104, which is further attached to the tapered section 106. A fixed guide wire 110, with a core wire 111 and an outer layer 113, extends distally from the distal end of the tapered section 106. It should be noted that only a portion of the length of the guide wire 110 is shown in Figure 1.

[0029] Figure 1 shows the guide tube 115 with a radiopaque marker 122 positioned fully forward, located through an opening 131 in the outer tube extension 104. The inner surface of the outer tube extension 104 may be made of a rigid material such as metal or high-durometer plastic to form part of the tubular shaft 120 and, in some cases, to ensure that the guide tube 115 does not bend as it is moved forward and backward.

[0030] Some embodiments of PTAC100 may use multiple different tubular structures, such as four (or two, three, five, or other numbers), instead of the outer tube 102 and the outer tube extension 104. Clearly, the proximal region may be a first tubular structure, such as a metal hypo tube in some cases. The metal hypo tube can be connected at its distal end to a second tubular structure, such as a relatively rigid plastic tube of about 20 cm, which can be further connected to a third tubular structure, such as a softer and more flexible plastic tube of about 10 cm, which connects to a fourth tubular structure, the tube 102 shown in Figure 1. Several more tubular structures have been considered, including tubular structures of the same or different lengths and / or the same or different materials. The plastic tubes may, in some cases, have the same inner and outer diameters. The outer tube extension 104, which is the distal end portion of the catheter body, typically has an inner diameter slightly larger than the soft outer tube 102, such as being approximately 20%, 15%, 10%, 5%, 3%, 2%, 1% or less in inner diameter, or including any two of the above values. The manifold 125, which connects the inner tube 105 to the injection tube 116, is coaxial within the plastic tube and is at least a few centimeters proximal to the outer tube extension 104, which is the distal end portion of the catheter body of the PTAC 100.

[0031] In a preferred embodiment, the intermediate tube 103 is attached to the proximal metal hypotube, and the inner tube 105 is also attached to the proximal portion formed from the metal hypotube.

[0032] The central support 121 shown in Figure 1 can, in some cases, be a mechanically non-expandable and non-inflatable central support that supports the guide tube 115 both when the guide tube 115 is pushed distally and after the guide tube 115 has been fully deployed. This central support 121 also provides radial support for the advanced guide tube 115, which prevents the guide tube 115 from moving away from the inner wall of the target vessel when the injection tube 116 is advanced forward through the guide tube 115 to its desired position, for example, 2-4 mm beyond the inner wall of the target vessel. In exceptional cases, the injection needle 119 at the distal end of the injection tube 116 may be advanced to a depth of 8 mm or more beyond the inner wall of the target vessel. Additional lateral support for the guide tube 115 is provided by the sides of the opening 131, which, in combination with the central support 121, can be very advantageous for radial and circumferential / lateral support as assistance both during the advancement and outward expansion of the guide tube 115, and during the delivery of the injection needle 119 penetrating the inner wall of the target vessel. The support may have deflection surfaces such as curved or straight inclined sections, the inclined sections of which, in the curved embodiment, may correspond to the radius of curvature of the distal surface of the guide tube 115. The guide tube 115 can slide along deflection surfaces such as the curved inclined section 144 (shown in Figure 4) of the central support 121 when the guide tube 115 is pushed. The guide tube 115 advances toward the distal end of the PTAC 100 toward the opening 131. The guide tube 115 can interact with deflection surfaces such as the curved inclined section 144 of the central support 121 as the guide tube 115 is guided toward the opening 131.

[0033] The pre-formed radius of curvature of the injection tube 116 may be similar to the radius of curvature of the guide tube 115, so that the guide tube 115 maintains its position in contact with the inner wall of the target vessel as the injection tube 116 is advanced to penetrate the inner wall of the target vessel. More specifically, the radius of curvature of the central axis of the distal portion of the injection tube 116 may be approximately the same as the radius of curvature of the central axis of the guide tube 115. In some embodiments, the guide tube has a non-damaging, rounded distal end so that it is not configured to penetrate the inner wall of the lumen of the target.

[0034] As shown in Figure 1, the inner tube 105 with a fluid injection lumen 133 is connected to three injection tubes 116 through a manifold 125, so that the lumen of the injection tubes 116 is in fluid communication with the lumen 133. The inner tube 105 and the manifold 125 can slide along the longitudinal axis of the PTAC 100 inside the intermediate tube 103, which is shown to have a uniform diameter over its length, including the coaxial portion outside the manifold 125.

[0035] The manifold 125 is positioned within the lumen of the inner tube 105, on a portion of the tube 105 proximal to its distal end. Both the inner tube 105 and the manifold 125 are coaxially positioned within the outer tube 102 of the PTAC 100, proximal to the outer tube extension 104, which is the distal end region of the outer body of the PTAC 100.

[0036] The proximal end of the injection tube 116 is in fluid communication with the injection lumen 133 of the inner tube 105. The longitudinal movement of the inner tube 105 within the uniform diameter intermediate tube 103 also moves the manifold 125 and the attached injection tube 116 longitudinally. This longitudinal movement, caused by a control mechanism near the proximal end of the PTAC 100, advances and retracts the injection tube 116 through the lumen of the guide tube 115 so as to expand outward to penetrate the wall of the target vessel in order to facilitate the delivery of resecting fluid.

[0037] A guide tube connector 132 connects the three guide tubes 115 to an intermediate tube 103 that provides propulsion for the forward and backward movement of the three guide tubes 115. The movement of the intermediate tube 103 is generated by the movement of a control mechanism at the proximal end of the PTAC 100. A manifold 125 is located inside the distal portion of the inner tube 105 and integrally connects the three infusion tubes 116 such that the forward and backward movement of the inner tube 105 provides simultaneous forward and backward movement of the infusion tubes 116. Also shown are flushing spaces between several tubes. Clearly shown are the outer annular space between the intermediate tube 103 and the outer tube 102, and the inner annular space between the inner tube 105 and the intermediate tube 103. Each of these spaces will be flushed with normal saline solution before insertion of the PTAC 100 into the patient's body.

[0038] The guide tube 115 and the guide tube connector 132 are coaxially mounted in the distal section of the intermediate tube 103. Therefore, longitudinal movement of the intermediate tube 103 causes longitudinal movement of the guide tube connector 132 and the guide tube 115, thereby allowing the mechanism in the proximal section of the PTAC 100 to advance and retract relative to the outer tube 102 and the outer tube extension 104. The guide tube connector 132 integrally connects the three guide tubes 115 such that the advance and retraction of the intermediate tube 103 provides simultaneous advance and retraction of the guide tubes 115.

[0039] In some embodiments, the penetration depth limiter may be a mechanism that restricts the forward movement of the distal end of the inner tube 105 relative to the guide tube connector 132. In some embodiments, the penetration depth limiter may be a mechanism in the proximal region of the PTAC 100, such as a distinguished position of a slider as described herein.

[0040] In some embodiments, one or more components of the PTAC100 are typically made from plastic materials such as polyamide, polyurethane, nylon, or Tecotan. These include the outer tube 102, the intermediate tube 103, the inner tube 105, the outer tube extension 104, the inner and / or outer layers of the guide tube 115, the tapered section 106, the support section 121, the guide tube connector 132, and the manifold 125. The manifold 125 may be a molded part or may be epoxy or other resin injected to bond the injection tube integrally within the lumen of the inner tube 105. It is also conceivable that any or all of the inner tube 105, the intermediate tube 103, or the outer tube 102 may be metal hypotube or metal-reinforced plastic tubing. The injection tube 116 is typically made from a resilient metal or a shape-memory metal such as Nitinol. The radiopaque wire 118 and the radiopaque markers 122 on the guide tube are made from a radiopaque material such as gold, platinum, tantalum, or alloys of these metals or similar metals.

[0041] Figure 2 is a side view of an embodiment of a control handle 200 designed for use with the PTAC 100 shown in Figure 1. The handle 200 may be designed to simplify the operation of the PTAC 100 while incorporating the features of appropriate safety devices.

[0042] The main body 210 of the handle 200 can be of any shape. In the illustrated embodiment, the main body 210 has a relatively rectangular or rounded cross-section with a beveled or rounded edge where the side surface 211 of the handle intersects with the bottom surface 215 of the handle. A finger rest 212 may be provided to improve the comfort of holding the handle 200 and is positioned so that the operator's hand can be positioned to best operate the main control unit of the handle 200. The control unit of the handle 200 may include a release button 222, a release button 226, and a slider 224. The slider 224 is an example of a longitudinal movement mechanism that can advance and retract the guide tube 115 of the PTAC 100 in Figure 1 relative to the catheter body of the PTAC 100, and can also advance and retract the injection tube 116 of the PTAC 100 with the needle 119 relative to the guide tube 115. The control unit may include, for example, buttons, dials, switches, sliders, etc.

[0043] In some embodiments, the release button 226 is optional. In some embodiments, the release button 226 is a manual locking part of the release button 222. In some embodiments, the release button 226 is a manual locking part of the slider 224. In some embodiments, the release button 222 is a switch or toggle that allows a user to move between a locked state and an unlocked state. In some embodiments, the release button 222 can be pushed down or pulled up so that a user can move between a locked state and an unlocked state. In some embodiments, the release button 222 can automatically spring up when released. In some embodiments, the release button 222 can remain pressed down when pressed. In some embodiments, the release button 226 is distal to the release button 222, and the release button 222 is further distal to the slider along the main body 210 of the handle 200 in the axial direction, as shown. Other configurations are also conceivable that allow the release button 222 to be set to either a locked or unlocked state.

[0044] As described herein, the slider 224 can continuously extend the guide tube 115 to the first position and the injection tube 116 to the second position. As described herein, the slider 224 can also continuously retract the injection tube 116 to the first position and the guide tube 115 to the second position. As described herein, the slider 224 can extend and retract all guide tubes 115 simultaneously. As described herein, the slider 224 can extend and retract all injection tubes 116 simultaneously.

[0045] As described herein, the slider 224 can engage with a manifold 125 connecting the inner tube 105 to the injection tube 116. The slider 224 can move the manifold forward and backward to deploy the injection tube 116. As described herein, the slider 224 can engage with a guide tube connector 132 connecting the intermediate tube 103 to the guide tube 115. The slider 224 can move the guide tube connector 132 forward and backward to deploy the guide tube 115. The three guide tubes 115 are connected to each other near their proximal ends by the guide tube connector 132.

[0046] The release button 222 may include both a locked and an unlocked state. In some embodiments, the release button 222 may be pressed so that it is up when locked and down when unlocked. When pressed and released, the release button 222 may remain in the unlocked (down) state, allowing longitudinal movement of the slider 224. If the operator accidentally presses the release button 222 and wants to spring it back up to the locked (up) state, this can be achieved by pressing the release button 226.

[0047] In some embodiments, the release button 222 can allow movement of the slider 224 in the released state and prevent movement of the slider 224 in the locked state. In some embodiments, the release button 222 can remain in the released state until movement of the slider 224 causes the release button to engage in the locked state. In some embodiments, the release button 222 can remain in the released state until the release button 226 is pressed. In some embodiments, the release button 222 can remain in the locked state until the release button 222 is pressed. In some embodiments, the release button 222 can be overridden by continuously pressing the release button 222 to prevent it from engaging in the locked state. Other configurations are also possible.

[0048] In some embodiments, the operator can activate the release button 222 on the handle by pressing the release button 222. In some embodiments, the operator can move the slider 224 distally to advance at least one guide tube away from the catheter body until the distal end of at least one guide tube is close to the inner wall of a blood vessel. In some embodiments, the slider 224 moves a preset distance. In some embodiments, the slider 224 moves at least one guide tube a preset distance. In some embodiments, the release button 222 is deactivated when at least one guide tube is advanced by the slider 224. In some embodiments, the release button 222 is released when at least one guide tube is advanced by the slider 224. In some embodiments, the movement of the slider 224 engages the release button 222. In some embodiments, the movement of the slider 224 automatically springs the release button 222 upward. In some embodiments, the slider 224 moves stepwise only between predetermined stops as described, while in other embodiments, the slider 224 can move continuously throughout its operating range.

[0049] In some embodiments, the operator can reactivate the release button 222 by pressing the release button 222, for example. In some embodiments, the operator can move the slider 224 to extend at least one injection tube beyond the distal end of at least one guide tube. In some embodiments, the slider 224 moves a predetermined distance. In some embodiments, the slider 224 moves at least one injection tube a predetermined distance. In some embodiments, the slider 224 penetrates the inner wall of the target vessel to puncture at least one injection tube. In some embodiments, the slider 224 positions the fluid outlet of at least one needle into a mass of tissue outside the inner wall of the target vessel. In some embodiments, the operator can attach a fluid source to the catheter. In some embodiments, the operator can inject fluid through the injection lumen of the catheter, out from the fluid outlet of the needle, into a mass of tissue outside the inner wall of the vessel. In some embodiments, the movement of the slider 224 engages the release button 222.

[0050] In some embodiments, the operator can reactivate the release button 222 by pressing it, for example. In some embodiments, the operator can move the slider 224 to retract at least one injection tube toward the distal end of at least one guide tube. In some embodiments, the movement of the slider 224 causes the release button 222 to engage in the locked position.

[0051] In some embodiments, the operator can reactivate the release button 222 by pressing it. In some embodiments, the operator can move the slider 224 so as to retract at least one guide tube toward the catheter body. In some embodiments, the movement of the slider 224 causes the release button 222 to engage.

[0052] In some embodiments, marking lines 232, 234, and 236, accompanied by corresponding catheter state icons 242, 244, and 246, can indicate the position of the slider 224. In some embodiments, marking lines 232, 234, and 236, accompanied by corresponding catheter state icons 242, 244, and 246, can indicate the position where the release button 222 enters the locked state. In some embodiments, marking lines 232, 234, and 236, accompanied by corresponding catheter state icons 242, 244, and 246, can indicate the position where further movement of the slider 224 is prevented by the release button 222 until the release button 222 is activated, such as by pressing the release button 222. In some embodiments, the release button can maintain the position of the slider 224, and consequently the position of the guide tube. In some embodiments, the release button can maintain the position of the slider 224, and consequently the position of the injection tube. In some embodiments, the slider 224 may have exactly three positions corresponding to the three marks shown in Figures 5A to 5I.

[0053] The control unit of the handle 200, including the release button 222, the release button 226, and the slider 224, may be located on the upper side of the handle 200. The control unit may face the user when the user grips the handle 200. The upper side of the handle 200 includes a rounded or beveled surface 208. The re-locking button or release button 226 may be located on the upper surface of the handle 200. The control unit of the handle 200, including the release button 222, the release button 226, and the slider 224, can be arranged in any order. In the illustrated embodiment, the release button 226 is distal to the release button 222. In the illustrated embodiment, the release button 222 is distal to the slider 224. Other arrangements are possible, including any order, coaxial, or offset.

[0054] The distal end of the main body 210 has a tapered section 206. Distal to the tapered section 206 is a strain reduction section 204 located outside the outer tube 102 of the PTAC 100 shown in Figure 1.

[0055] Proximal to the main body 210 is a proximal tapered section 214. Proximal to the proximal tapered section 214 is a connector 202 for attaching a syringe (not shown) or other fluid dispensing mechanism. The connector 202 may be a standard Luer or Luer lock connector, or a non-standard connector. The lumen of the connector 202 is in fluid communication with the lumen 133 of the inner tube 105 of the PTAC100 in Figure 1. A flushing tube 252 with a Luer connector 254 is in fluid communication with two spaces, namely, 1) the space between the inner tube 105 and the intermediate tube 103, and 2) the space between the intermediate tube 103 and the outer tube 102, as shown in Figure 1, and is used to flush the catheter with saline before operation of the PTAC100.

[0056] Figure 3 shows a magnified view of area 223 of Figure 2, with the release button 222, the release button 226, and the slider 224. Also shown are the reference lines 232, 234, and 236, with corresponding catheter status icons 242, 244, and 246. These reference lines and catheter status icons are positioned to clearly indicate to the operator the current state of the distal end of the PTAC 100. Reference line 232 corresponds to the closed position of the PTAC 100, as indicated by icon 242. Reference line 234 corresponds to the position of the PTAC 100 where the guide tube 115 is deployed but the injection tube 116 with the needle 119 is still retracted. Icon 244 indicates this position. Reference line 236 corresponds to the position of the PTAC 100 where the guide tube 115 is deployed and the injection tube 116 with the needle 119 is deployed, as shown in Figure 1. Icon 246 indicates this state. The reference lines 232, 234, and 236, and the catheter status icons 242, 244, and 246 may be etched, engraved, or printed on the surface 208, or in some embodiments, they may be presented as one or more markings. The slider 224 may be aligned with the reference lines and catheter status icons at various stages of the operation of the PTAC 100. When the PTAC 100 is closed, the distal edge of the slider 224 may be aligned with reference line 232. When the guide tube 115 is deployed, the distal edge of the slider 224 may be aligned with reference line 234. When the injection tube 116 is deployed, the distal edge of the slider 224 may be aligned with reference line 236. In the illustrated embodiments, the icons are figures that represent the shape of the catheter. Other icons may be, for example, shapes, words, letters, numbers, marks, images, colors, etc. In some embodiments, moving the slider 224 may provide audible and / or tactile (e.g., haptic) feedback to alert the operator to different positions of the slider 224, as an alternative to or addition of visual markers.

[0057] Figure 4 shows a top view of the handle 200, looking down at the top surface 218 of the handle 200. Figure 4 shows the main body 210 with the top surface 218, the outer tube 102 of the PTAC100 in Figure 1, the distal tapering section 206, the strain reduction section 204, the proximal tapering section 214, the connector 202, the buttons 226 and 222, the slider 224, and the marking lines 232, 234, and 236. Catheter status icons are shown but are not labeled.

[0058] In Figure 2, rounded (chamfered) or beveled (cornered) surfaces 208 and 209 can be seen between the side 211 of the handle and the top surface 218 of the handle 200. The advantage of beveled or rounded surfaces in some cases is that when the handle 200 is operated with the top 218 facing upwards, or with either side of the main body (e.g., reference numeral 211) facing upwards, at least one set of catheter status icons 242, 244, and 246 is visible. When beveled edges are used instead of rounded (chamfered) edges, angles of 10 to 80 degrees may be functional in some embodiments, but angles closer to 45 degrees may be optimal.

[0059] Figures 5A to 5I show steps of some embodiments of a method of using the handle 200 to deploy and retract the guide tube 115 and the injection tube 116 with the needle 119 of the PTAC 100 in Figure 1, the distal end configuration is shown in Figures 8 to 10 of Patent Documents 2, 3, 4, 5, 6, 7, and 8.

[0060] Some embodiments of the method for using the handle 200 after the PTAC 100 disclosed herein can be initiated after one or more of the following: 1. PTAC is removed from its packaging. 2. Wash with physiological saline or another medium. 3. The injection lumen 133 in Figure 1 is filled with fluid. 4. The PTAC100 is a handle control unit as shown in Figure 5A, and is arranged in a closed configuration as shown in Figure 8 of, for example, Fischell et al.'s Patent Documents 2, 3, 4, 5, 6, 7, and 8. In some embodiments, only some or all of the steps are performed. In some embodiments, the steps performed are performed in the order described above or in a different order.

[0061] Steps for using a device to deliver fluid to the outside of the inner wall of a target vessel may include one or more of the following: 1. In the closed configuration shown in Figure 5A, where the distal end of the slider 224 is aligned with the guide line 232, the PTAC 100 is delivered to the desired site in the human body. 2. The operator presses in the release button 222 to release it. The button 222 then remains pressed in the release position. This allows the slider 224 to move distally, and the slider 224 is advanced distally until it stops at the mark line 234. The release button on the handle 200 then springs back automatically, as shown in Figure 5C, re-locking the slider 224 in this position. The icon 244 now indicates to the operator that the guide tube 115 is deployed as shown in Figure 9 of Fischell et al. Patent Documents 2, 3, 4, 5, 6, and 7. The operator can then confirm that the guide tube 115 is deployed by angiography or other imaging technique. 3. The injection tube 116 of the PTAC100 with the needle 119 shown in Figure 1 can be deployed by pressing the release button 222, for example, as in step 2, and the slider 224 is advanced distally until it stops as shown in Figure 5E, with the distal end of the slider 224 aligned with the mark line 246. The release button 222 springs back up, re-locking the slider 224 in place. In this state, the injection tube 116 of the PTAC100 with the needle 119 is fully deployed as indicated by the icon 246, as shown in Figure 10 of Fischell et al.'s Patent Documents 2, 3, 4, 5, 6, and 7. The operator can then confirm that the injection tube 116 is deployed by angiography or other imaging technique. 4. A fluid supply source (e.g., a syringe not shown) is attached to the connector 202, for example, in Figures 2 and 4, and the fluid is delivered to a desired location on the human body through the needle 119. 5. The fluid supply source is removed from the coupler 202 shown in Figures 2 and 4. 6. Next, the operator presses in the release button 222 to release it, as shown in Figure 5F, and retracts the slider 224 proximal to the guide line 234, as seen in Figure 5G, where the slider 224 stops and the release button 222 springs up to re-lock the mechanism. This step retracts the injection tube 116 of the PTAC 100 with the needle 119, and the state in which its guide tube 115 corresponding to the icon 244 is extended is shown, for example, in Figure 9 of Fischell et al. Patent Documents 2, 3, 4, 5, 6, and 7. 7. The operator presses the release button 222 again to release it, and the release button 222 remains in the released position as shown in Figure 5H. The operator can then retract the slider 224 proximal until its distal end is aligned with the mark line 232 as shown in Figure 5I, pushing the PTAC 100 to the position it was in when it started in step 1, in its closed position corresponding to icon 242. In some embodiments, all or some of the steps are performed. In some embodiments, the steps performed are performed in the order described above or in a different order.

[0062] A feature of the addition of a handle in some embodiments is that the release button 222 is kept down to prevent it from springing up, and the slider 224 is moved backward from a state where its distal end is aligned with the mark line 236 until its distal end is aligned with the mark line 232, thereby allowing the operator (using one or both hands) to move from the state in Figure 5E to the state in Figure 5I. By using both hands, the operator can press the release button 222 with one finger and slide the slider 224 proximal with another finger (e.g., from the same hand or a different hand).

[0063] In some embodiments, the process can be advanced continuously from Figure 5A to Figure 5B, Figure 5C, and Figure 5D, and then to Figure 5E, by keeping the release button 222 down; however, this method may not be recommended in some cases.

[0064] In Patent Documents 9 and 10, Fischell et al. describe sympathetic nerve sensing catheters (SNSCs) and perivascular nerve resection and sensing catheters (PNASCs) that can be used to sense nerve activity, stimulate nerve activity, and / or resect nerve activity by chemical or energetic resection. Figure 6 is a longitudinal cross-sectional view of the distal portion of a prior art SNSC / PNASC10 as shown in Figure 2 of Patent Documents 9 and 10, which are incorporated in their entirety by reference herein.

[0065] Figure 6 is a schematic diagram of the distal portion of a nerve sensing catheter (NSC) 10 designed to deliver electrical energy to tissues to stimulate them with electrical energy, and / or to provide, for example, the acquisition and evaluation of the induced activity, in order to sense energy from extravascular tissues within the human body. The NSC 10 is shown in its open position and shows an inner tube 11, an intermediate tube 12, an outer tube 13, and an outer tube extension 14 having a distal opening 15 through which a guide tube 30 with a radiopaque marker 36, a distal tip 34, and an outer layer 32 is advanced outward from the body of the NSC 10. Also shown are a tapered section 16 and a fixed guide wire 40 with a distal tip 42. The NSC comprises three conduits 20 with an outer insulator 22 and a sharp wire 24, and two of the three guide tubes and conduits are shown in their fully extended position (the third conduit is not shown). The sharp wire 24 may be made from or coated with a radiopaque material such as gold or platinum.

[0066] The conduit 20 extends all the way to the proximal end of the NSC 10, where it connects to the energy-providing electronic device 500. The distal end 24 of the conduit 20 is shown here in the distal portion of the NSC 10. The conduit 20 extends through the catheter body within the lumen of the inner tube 11. In some embodiments, the insulator 22 that insulates the conduit within the catheter body does not extend around the most distal portion of the conduit 20, as this portion terminates as a sharp wire / needle 24 that can penetrate the blood vessel wall and act as an electrode.

[0067] The opening 15 in the distal portion of the catheter supports the guide tube 30 when it is advanced outward to provide structural support during the subsequent deployment of the sharp wire 24. While the NSC 10 in Figure 6 has three guide tubes 30, other embodiments may have as few as one guide tube, as many as eight guide tubes, or more guide tubes (e.g., in the range of one, two, three, four, five, six, seven, eight, or more, or any two of the above values), and the optimal number is typically three or four in the case of renal nerve debridement. For target vessels of larger diameter, the use of four to eight or more guide tubes 30 and conduits 20 may be suggested.

[0068] In addition to providing conductivity from the proximal end of the NSC to the distal sharp wire 24, the conduit 20 can also be adapted to be hollow to provide a passage for fluid injection near the tip of the sharp wire 24. An improved version of the NSC is disclosed herein, which provides both nerve sensing and nerve resection capabilities. A catheter with these two functions is called a perivascular nerve resection and sensing catheter (PNASC). The catheter described herein can provide one or more of the following: namely, It provides both electrical sensing and stimulation using sharp wires 24 that act as electrodes for both sensing neural activity and supplying energy to tissue. Electrical energy such as RF is supplied to a sharp wire 24 that acts as an electrode providing energy-based cutting. The conduit 20 has a fluid passage with an outlet near the distal end of the sharp wire 24 for injecting resection fluid for chemical nerve resection and / or for dispensing anesthetic / analgesic drugs such as lidocaine, and / or To provide energy-based resection, such as resection of the perivascular region delivered by the conduit 20, an ultrasonic transducer is provided either in the main body of the PNASC or in the distal portion of the conduit 20.

[0069] Different shapes are conceivable for the distal opening (or window) 15 in the outer tube extension 14 from which the guide tube 30 exits. These possible shapes include elliptical or rounded shapes, such as a racetrack-type design with axially curved (e.g., rounded) proximal and distal ends and straight sides. For better delivery through the guide catheter to the renal artery, it is also conceivable that there may be a movable flap (not shown) covering each opening 15 or slit that can be opened to smooth the outer surface of the NSC. Such a movable flap may be operated under the control of the catheter handle in the proximal segment of the catheter. Mechanical action of the catheter may function to retract the flap before the guide tube 30 is deployed. Alternatively, the flap may be made sufficiently flexible and soft so that it is only pushed aside by the guide tube 30 during deployment.

[0070] It may be a feature of some embodiments of the present invention that the guide tube 30 serves as a guide element for the needle or conduit, providing structural support for the ultrathin conduit 20. The three conduits 20, sensor 24, and guide tube 30 are uniformly spaced at approximately 120 degrees apart around the periphery of the catheter 10. Uniform spacing improves the sensing performance of the NSC 10. It is also conceivable that the spacing be non-uniform, for example, two of them may be 50 degrees apart and the third one 155 degrees apart from either of the first two. In an alternative embodiment, the catheter for sensing activity from nerves outside the lumen of a target blood vessel in the human body may include only one conduit 20. In the single conduit 20 embodiment, a portion of the body of the NSC 10, such as the outer conduit extension 14, will typically be pressed against the inner wall of the opposite artery in the diametrical direction of the contact point where the needle guide element / guide tube 30 expands outward to contact the arterial wall.

[0071] The proximal end of Figure 6 shows three concentric tubes that form the central portion of the SNSC / PNASC10: the outer tube 13, the middle tube 12, and the inner tube 11. At its distal end, the outer tube 13 is attached to an outer tube extension 14, which is further attached to the tapered section 16. A fixed guide wire 40, with a core wire 42 and an outer layer 44, extends distally from the distal end of the tapered section 16.

[0072] Figure 6 shows the guide tube 30 in its fully extended position, with the outer layer 32, distal tip 34, and radiopaque marker 36, when advanced through the opening 15 in the outer tube extension 14. The inner surface of the outer tube extension 14 forms part of the tubular shaft 21. In some embodiments, the tubular shaft 21 is preferably made of a rigid material such as metal or high-durometer plastic so that it does not bend as the guide tube 30 is advanced and retracted.

[0073] Coaxial within the lumen of the guide tube 30 is an insulated wire 20 with an insulated outer layer 22A and a core wire 24. As described herein, in some embodiments the core wire 24 is hollow to allow fluid delivery, and in some embodiments the core wire 24 is solid. The uninsulated distal portion of the wire 20 forms an electrode 25. The electrode 25 can act as a sensor in combination with one or both of the other two electrodes 25 at the ends of the other two sharp wires 20, or with a remote electrode electrically connected to the patient. The electrode 25 can be used to measure sympathetic nerve activity in the perivascular space outside the renal artery. The electrode 25 can be used to stimulate nerves. The electrode 25 can be used to deliver energy to sever nerves.

[0074] The central support 19 shown in Figure 6 supports the guide tube 30 both when it is pushed distally and after it has fully unfolded. This central support 19 also provides radial support for the advanced guide tube 30, which prevents the guide tube 30 from moving away from the inner wall of the target vessel when a sharp wire 20 is advanced through the guide tube 30 to its desired position in the space around the outer membrane by 2–10 mm beyond the inner wall of the target vessel. Additional lateral support for the guide tube 30 is provided by the sides of the opening 15, which, in combination with the central support 19, provides radial and circumferential / lateral support, as it provides assistance both during the advancement and outward expansion of the guide tube 30 and during the delivery of the wire 20 through the inner wall of the target vessel. The support may have deflection surfaces such as curved or straight inclined sections, the inclined sections of which, in the curved embodiment, may correspond to the radius of curvature of the outer surface of the guide tube 30.

[0075] Another possible feature of the SNSC / PNASC10 is that each sharp wire 20, when measured unconstrained, has a central axis with the same or nearly the same radius of curvature as the central axis of the corresponding guide tube 30. Furthermore, it is preferable that the length of the guide tube 30 is at least the same as the distal curved portion of the sharp wire 20. This design constrains the curved portion of each sharp wire 20 within the lumen of the guide tube 30 so that the sharp wire 20 cannot twist or change position.

[0076] As shown in Figure 6, a cylinder or manifold 17 attaches the inner tube 11 to three sharp wires 20. The cylinder can be formed from any material, such as plastic. The inner tube 11 and cylinder 17 can slide along the longitudinal axis of the SNSC / PNASC 10 inside the intermediate tube 12. The intermediate tube is shown to have a uniform diameter over its length, including the coaxial portion outside the cylinder 17.

[0077] Some embodiments of the SNSC / PNASC10 use four different tubular structures instead of the outer tube 13 and outer tube extension 14. Specifically, the proximal section may be a metal hypotube. The metal hypotube can be connected at its distal end to a relatively rigid plastic tube about 20 cm long, which in turn can be connected to a softer, more flexible plastic tube about 10 cm long, which may be the tube 13 shown in Figure 6.

[0078] In a preferred embodiment, the intermediate tube 12 is attached to a proximal metal hypotube, and the inner tube 11 is also attached to a proximal portion formed from a metal hypotube. SNSC / PNASC10 and PTAC100 may have the features described herein and / or the features described in the patents incorporated by reference.

[0079] Figure 7 is a side view of some embodiment of a control handle 300 designed for use with the SNSC / PNASC10 of Figure 6. The handle 300 may be designed to simplify the operation of the SNSC / PNASC10 while including the features of appropriate safety devices. The control handles 200 and 300 may have any of the features described herein.

[0080] The main body 310 of the handle 300 may include any shape. The main body 310 is configured to be grasped by at least one hand of the operator of the device. The main body 310 may have a relatively rectangular or rounded cross-section with a beveled or rounded edge where the side surface 311 of the handle intersects with the bottom surface 315 of the handle. In some embodiments, a finger rest 312 is provided to improve the comfort of holding the handle 300 and is positioned so that the operator's hand can be positioned to best operate the main control unit of the handle, including the release button 322, the release button 326, and the slider 324. The slider 324 is an example of a longitudinal movement mechanism that can advance and retract the guide tube 30 of the SNSC / PNASC10 relative to the catheter body of the SNSC / PNASC10, and can also advance and retract the wire 20 of the SNSC / PNASC10 relative to the guide tube 30.

[0081] The release button 322 has a locked (up) state and a released (down) state. When pressed and released, the release button 322 can remain in the released (down) state, which allows the operator to engage in longitudinal movement of the slider 324. If the operator accidentally presses the release button 322 and wants to flip it back up to the locked (up) state, this can be achieved by pressing the release button 326.

[0082] Also shown are reference lines accompanied by icons indicating the corresponding catheter state. These reference lines and catheter state icons are positioned to clearly indicate to the operator the current state of the distal end of the SNSC / PNASC10. Some reference lines correspond to the closed position of the SNSC / PNASC10. Some reference lines correspond to the position of the SNSC / PNASC10 where the guide tube 30 is deployed but the wire 20 with the electrode 25 is still retracted. Some reference lines correspond to the position of the SNSC / PNASC10 where the guide tube 30 is deployed and the wire 20 with the electrode 25 is deployed as shown in Figure 6. The reference lines and catheter state icons may be etched, engraved, or printed on the handle 200. The slider 324 may be aligned with the reference lines and catheter state icons at various stages of the operation of the SNSC / PNASC10. In the illustrated embodiment, the icons are figures representing the shape of the catheter. Other icons may include shapes, words, letters, numbers, symbols, images, colors, and other non-visual symbols as described elsewhere in this specification.

[0083] The upper side of the handle 300 includes a rounded or beveled surface 308. A locking or release button 326 may also be located on the upper surface of the handle 300. The distal end of the main body 310 has a tapered section 306, and distal to that is a strain-reducing section 304 which is outside the outer tube 13.

[0084] Proximal to the main body 310 is a proximal tapered section 314. Proximal to the proximal tapered section 314 is a connector 302 for attaching a syringe (not shown) or other fluid dispensing mechanism. The connector 302 may be a standard Luer or Luer-lock connector or a non-standard connector. The lumen of the connector 302 is in fluid communication with the lumen 333 of the inner tube 11 of the SNSC / PNASC10 in Figure 6. A flushing tube 352 with a Luer connector 354 is in fluid communication with two spaces, namely, 1) the space between the inner tube 11 and the intermediate tube 12, and 2) the space between the intermediate tube 12 and the outer tube 13, as shown in Figure 6, and is used to flush the catheter with saline before operation of the SNSC / PNASC10.

[0085] Figure 7 also shows an embodiment of wires 365A-365C used to connect external devices to wire 20 in Figure 6. Each of the wires 365A-365C can be connected to an independent electrode. In some embodiments, wire 365A is connected to the electrode 25 of the first wire 20, wire 365B is connected to the electrode 25 of the second wire 20, and / or wire 365C is connected to the electrode 25 of the third wire 20. Wires 365A-365C can be connected to an external device 364. As described herein, the external device 364 may be for sensing electrical energy, stimulating with electrical energy, and / or supplying electrical energy. Other energy sources such as magnetic, ultrasonic, vibration, thermal, or cryogenic energy sources may be applied alone or in combination.

[0086] In some embodiments, the release button 322 can allow movement of the slider 324 in the released state and prevent movement of the slider 324 in the locked state. In some embodiments, the release button 322 can remain in the released state until movement of the slider 324 causes the release button to engage in the locked state. In some embodiments, the release button 322 can remain in the released state until the release button 326 is pressed. In some embodiments, the release button 322 can remain in the locked state until the release button 322 is pressed. In some embodiments, the release button 322 can be overridden by continuously pressing the release button 322 to prevent it from engaging in the locked state. Other configurations are also possible.

[0087] In some embodiments, the operator can activate the handle's release button 322 by pressing the release button 322. In some embodiments, the operator can move the slider 324 distally to advance at least one guide tube away from the catheter body until the distal end of at least one guide tube is close to the inner wall of the blood vessel.

[0088] In some embodiments, the operator can reactivate the release button 322 by pressing the release button 322, for example. In some embodiments, the operator can move the slider 324 to extend at least one wire 20 beyond the distal end of at least one guide tube 30. In some embodiments, the slider 324 penetrates at least one injection tube through the inner wall of the target vessel. In some embodiments, the slider 324 positions the electrode 25 of at least one wire 20 onto a mass of tissue outside the inner wall of the target vessel. In some embodiments, the operator can apply energy to the electrode to excise tissue. In some embodiments, the operator can apply energy to the electrode to sense nerves. In some embodiments, the operator can apply energy to the electrode to stimulate tissue.

[0089] Various other modifications, adaptations, and alternative designs are, of course, possible in consideration of the teachings above. Therefore, it should be understood at this time that, within the scope of the appended claims, the invention may be carried out in ways not explicitly described herein.

[0090] Certain features described herein in the context of a different embodiment may be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may be implemented separately or in any suitable partial combination in multiple embodiments. Furthermore, features may be described earlier as acting in a particular combination and may initially be claimed as such, but one or more features from a claimed combination may, in some cases, be implemented from the combination, and the claimed combination may be directed towards a partial combination or a variation of a partial combination.

[0091] The foregoing descriptions and examples are provided to illustrate various embodiments and are not intended to limit them unduly. The titles provided herein are for organizational purposes only and should not be used to limit embodiments. Each of the embodiments and examples disclosed herein may be considered individually or in combination with other embodiments, examples, and variations thereof. Furthermore, unless otherwise expressly stated, none of the steps of the methods disclosed herein are limited to any particular order of implementation. The references referred herein are incorporated in their entirety by reference. The description of an embodiment as “preferred” does not limit the use or scope of alternative embodiments.

[0092] The methods and apparatus described herein may take on various modifications and alternative forms, of which specific examples are shown in the drawings and described in detail herein. However, it should be understood that the embodiments disclosed naturally encompass variations, equivalents, and alternatives that fall within the spirit and scope of the various embodiments and appended claims described herein.

[0093] Depending on the embodiment, one or more actions, events, or functions of any algorithm, method, or process described herein may be performed in different sequences, added, merged, or excluded (for example, not all described actions or events are necessarily required for the implementation of the algorithm). In some examples, for example, in multiplexing, interrupt handling, multiple processors or processor cores, or other parallel architectures, actions or events may be performed concurrently rather than sequentially.

[0094] The use of words indicating continuity or sequence in time, such as "then," "next," "later," and "following," is generally intended to facilitate the flow of a document, and not to limit the sequence of actions being performed, unless otherwise explicitly stated or understood within the context in which they are used.

[0095] The various exemplary logic blocks, modules, processes, methods, and algorithms described in connection with the embodiments disclosed herein can be implemented as electronic hardware, computer software, or a combination of both. To clearly demonstrate this hardware- and software compatibility, the various exemplary components, blocks, modules, operations, and steps are generally described first in terms of their functionality. Whether their functionality is implemented as hardware or software depends on the specific application and design constraints imposed on the overall system. The described functionality can be implemented in various ways for each specific application, but such decisions should not be construed as resulting in a departure from the scope of this disclosure.

[0096] Among the many conditional words used herein, such as "can," "may," "may," and "for example," are generally intended to convey that some examples include certain features, elements, and / or states, but not other examples, unless otherwise explicitly stated or otherwise inferred in the context in which they are used. Therefore, such conditional words are generally not intended to imply that features, elements, blocks, and / or states are present in any required manner for one or more examples, or that one or more examples necessarily include logic for determining whether these features, elements, and / or states are included in or implemented in any particular embodiment, whether provided or directed by the author.

[0097] The methods disclosed herein may include certain actions taken by the implementer, but may also include, either explicitly or implicitly, commands from any third party to perform such actions. For example, an action such as "positioning electrodes" may include "commanding the positioning of electrodes."

[0098] The scope disclosed herein includes all overlaps, sub-scopes, and combinations thereof. Words such as “up to,” “at least,” “greater than,” “less than,” and “between” include the proposed number. Numbers preceded by terms such as “about” or “approximately” include the proposed number and should be interpreted on a contextual basis (e.g., should be interpreted with the most reasonably possible accuracy in that context, such as ±5%, ±10%, ±15%). For example, “about 1 hour” includes “1 hour.” Words preceded by terms such as “substantially” include the proposed word and should be interpreted on a contextual basis (e.g., should be interpreted as broadly as reasonably possible in that context). For example, “substantially vertical” includes “vertical.” Unless otherwise stated, all measurements are under standard conditions, including temperature and pressure. The phrase “at least one of” is intended to require at least one item from a consecutive list, and not to require one of each item of each type from each item in a consecutive list. For example, "at least one of A, B, and C" may include A, B, C, A and B, A and C, B and C, or A, B, and C. [Explanation of symbols]

[0099] 200, 300 control handle 202, 302 coupler 204, 304 Distortion reduction area 206, 306 distal tapering area 208, 209 Rounded surfaces, beveled surfaces 210, 310 Main Unit 211, 311 Side of the handle 214, 314 Proximal tapering zone 215, 315 Underside of the handle 218 Top surface 222, 322 Release button 223 area 224, 324 sliders 226, 326 Release button, Re-lock button Landmark lines 232, 234, 236 242, 244, 246 Catheter status icons 252, 352 flushing pipes 254, 354 Lure Connector 333 Lumen 364 External equipment 365A, 365B, 365C wires

Claims

1. A catheter body comprising a distal portion having a central axis extending in the longitudinal direction, at least one guide tube having a distal end, and at least one guide tube movable between a first position within the catheter body and a second position that is tilted as it moves away from the catheter body, wherein the at least one guide tube is configured to be positioned at the distal end in close proximity to the inner wall of a target vessel, At least one perforating body configured to penetrate the inner wall of the target vessel, wherein a portion of the at least one perforating body is coaxially positioned inside the at least one guide tube, A proximal handle adapted to advance and retract the at least one guide tube and the at least one perforator, wherein the proximal handle comprises a release mechanism having a locked state and an unlocked state, the proximal handle also comprises a single slider that can be slid longitudinally by the user along the catheter body, the single slider configured to move continuously from a proximal position to an intermediate position to advance the at least one guide tube, and from the intermediate position to a distal position to advance the at least one perforator, the movement of the single slider depends on the release mechanism being in the unlocked state, Equipped with, A catheter in which the release mechanism is automatically locked when the single slider is in the proximal position, the intermediate position, and the distal position.

2. The catheter according to claim 1, comprising three guide tubes and three perforating bodies.

3. The catheter according to claim 1, wherein the at least one perforating body is hollow and has a fluid outlet near the distal end of the at least one perforating body, and the catheter has an injection lumen that is in fluid communication with the fluid outlet of the at least one perforating body.

4. The catheter according to claim 1, wherein the at least one piercing body has a distal end forming an electrode, and the catheter body further comprises a wire extending the length of the catheter for transmitting an electrical signal between the at least one electrode and a connector near the proximal end of the catheter, the connector being adapted to connect the wire to an external device.

5. The aforementioned proximal handle is, The proximal position of the single slider in which both the at least one guide tube and the at least one perforating body are retracted, The intermediate position of the single slider, in which the at least one guide tube is advanced but the at least one perforating body is retracted, The position of the single slider in which both the at least one guide tube and the at least one perforating body are advanced, The catheter according to claim 1, comprising at least one marker line, selected from the group consisting of, associated with the position of the single slider indicating the state of the catheter.

6. The catheter according to claim 5, wherein two or more marker lines are included in the proximal handle.

7. The catheter according to claim 5, wherein the proximal handle includes a first marking line indicating the proximal position of the single slider in which both the at least one guide tube and the at least one perforating body are retracted; a second marking line indicating the intermediate position of the single slider in which the at least one guide tube is advanced but the at least one perforating body is retracted; and a third marking line indicating the distal position of the single slider in which both the at least one guide tube and the at least one perforating body are advanced.

8. The aforementioned proximal handle is, The proximal position of the single slider in which both the at least one guide tube and the at least one perforating body are retracted, The intermediate position of the single slider, in which the at least one guide tube is advanced but the at least one perforating body is retracted, The position of the single slider in which both the at least one guide tube and the at least one perforating body are advanced, The catheter according to claim 1, comprising at least one icon selected from the group consisting of the following, which is associated with the state of the catheter.

9. The catheter according to claim 8, wherein the proximal handle includes a first icon indicating the position of the single slider in which both the at least one guide tube and the at least one perforator are retracted; a second icon indicating the position of the single slider in which the at least one guide tube is advanced but the at least one perforator is retracted; and a third icon indicating the position of the single slider in which both the at least one guide tube and the at least one perforator are advanced.

10. The catheter according to claim 1, wherein the handle includes at least one flushing port.

11. The catheter according to claim 1, wherein the handle is provided with a finger rest to help position the hand of an operator operating the handle.

12. The catheter according to claim 1, wherein the single slider is a slide switch.

13. The catheter according to claim 5, wherein the upper surface of the handle has at least one marking line.

14. The catheter according to claim 13, wherein the upper surface of the handle has at least two marking lines.

15. The aforementioned at least one icon is, The upper surface of the handle and, One of the sides of the aforementioned handle, Both sides of the aforementioned handle, The chamfered or beveled surface between the upper and side surfaces of the handle, The catheter according to claim 8, which is placed at a location selected from the group consisting of the following.

16. The single slider is configured to continuously retract the at least one perforating body to a first position and the at least one guide tube to a second position. The catheter according to claim 1.

17. The single slider is configured to allow all of the guide tubes to be extended and retracted simultaneously. The single slider is configured to retract all of the perforations simultaneously. The catheter according to claim 1.

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