CATHETER FOR PERI-VASCULAR FLUID INJECTION

Abstract

An intravascular catheter for peri-vascular and/or peri-urethral tissue ablation includes multiple needles advanced through supported guide tubes which expand around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, and/or nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. Applications include renal denervation for the treatment of hypertension, atrial fibrillation, congestive heart failure, tissue ablation for COPD, BPH and prostate cancer and prevention of restenosis after balloon angioplasty or stent implantation and other disorders.

Claims

1. A catheter for fluid delivery to a volume of tissue in outside of the inside wall of a target vessel in a human body comprising: a catheter body comprising a catheter fluid injection lumen; a central axis extending in a longitudinal direction; a distal portion comprising at least one guide tube comprising a distal end, the at least one guide tube configured to be outwardly expandable in the radial direction beyond the outer surface of the catheter body with the distal end in proximity to the inside wall of the target vessel; at least one sharpened needle comprising a needle fluid injection lumen in fluid communication with the catheter fluid injection lumen, a portion of the at least one sharpened needle located coaxially inside of the at least one guide tube, and a proximal handle comprising an injection port in fluid communication with the catheter fluid injection lumen, the injection port comprising a check valve, the proximal handle configured to advance and retract the at least one guide tube and the at least one sharpened needle.

2. The catheter of claim 1 comprising three guide tubes and three sharpened needles.

3. The catheter of claim 1 wherein the at least one sharpened needle is hollow and comprises a fluid egress near the distal end of the at least one sharpened needle and the catheter fluid injection lumen in fluid communication with the fluid egress of the at least one sharpened needle.

4. The catheter of claim 1 wherein the proximal handle includes at least one indicia associated with the state of the catheter selected from the group consisting of: a. the position of the movement mechanism wherein the at least one guide tube and at least one injector tubes are both retracted, b. the position of the movement mechanism wherein the at least one guide tube is advanced but the at least one injector tube is retracted, and c. the position of the movement mechanism wherein the at least one guide tube and at least one injector tube are both advanced.

5. The catheter of claim 1 wherein the fluid is ablative fluid and wherein the check valve is integrated with the proximal handle and configured to prevent the ablative fluid from flowing back out of the injection port.

6. The catheter of claim 1 wherein the check valve is integrated with the proximal handle and configured to prevent air from entering the catheter fluid injection lumen.

7. The catheter of claim 1 wherein the check valve is integrated with the proximal handle and configured to prevent blood from flowing back through the catheter.

8. A catheter for fluid delivery through at least two injection needles into tissue outside of the interior wall of a target vessel of a human body, the catheter comprising: a catheter body comprising an outer surface, a central axis extending in a longitudinal direction, and a fluid injection lumen; at least two guide tubes configured to advance distally and expand outwardly toward the interior wall of the target vessel; a support structure; at least two injector tubes with distal injection needles, each of the distal injection needles comprising an injection lumen in fluid communication with the fluid injection lumen of the catheter body, the at least two injector tubes with distal injection needles configured to be advanced outwardly, guided by the at least two guide tubes to penetrate the interior wall of the target vessel, the injection needles comprising a distal opening for fluid delivery into the tissue outside of the interior wall of the target vessel; and a check valve positioned near the proximal end of the fluid injection lumen.

9. The catheter of claim 8 wherein the support structure comprises a deflection surface, the deflection surface configured to deflect the distally moving guide tubes outward to a pre-set radial distance from the outer surface of the distal portion of the catheter body.

10. The catheter of claim 8 comprising three guide tubes.

11. The catheter of claim 8 wherein the at least one distal injection needle is hollow and includes fluid egress near the distal end of the injection needle and the fluid injection lumen of the catheter body is in fluid communication with the fluid egress of the at least one injection needle.

12. The catheter of claim 8 wherein the check valve is located at the proximal end of the catheter body.

13. The catheter of claim 8 wherein the catheter body comprises an injection port at the proximal end of the fluid injection lumen and the check valve is attached to a proximal end of the injection port.

14. The catheter of claim 8 wherein the check valve is integral to the proximal portion of the fluid injection lumen.

15. A catheter comprising: a catheter body comprising a fluid injection lumen; at least one guide tube comprising a distal end, the at least one guide tube moveable between a first position within the catheter body and a second position inclined away from the catheter body, wherein the at least one guide tube is configured to be positioned with the distal end in proximity to an inside wall of a target vessel; at least one penetrator comprising an injection lumen in fluid communication with the fluid injection lumen of the catheter body, the at least one penetrator configured to penetrate the inside wall of the target vessel, a portion of the at least one penetrator located coaxially inside of the at least one guide tube; a proximal handle configured to advance and retract the at least one guide tube and the at least one penetrator, and a check valve in fluid communication with the fluid injection lumen of the catheter body.

16. The catheter of claim 15 wherein the check valve is integrated into the proximal handle.

17. The catheter of claim 15 wherein the check valve is integrated into a fluid injection port in a proximal portion of the catheter.

18. The catheter of claim 17 wherein the fluid injection port includes a non-Luer connector.

19. The catheter of claim 15 further includes a vial of ablative fluid and at least one syringe.

20. The catheter of claim 15 wherein the check valve is configured to allow ablative fluid to flow in one direction from a proximal injection port to an egress of the at least one penetrator and prevent ablative fluid from flowing in the opposite direction out of the proximal injection port.

21-60. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0102] FIG. 1 is a schematic view of a longitudinal cross-section of a distal portion of the PTAC in its open position for delivery of fluid into a volume of tissue outside of the inside wall of a target vessel.

[0103] FIG. 2 is a longitudinal cross-section of a distal portion of the PTAC in its open position for delivery of fluid into a volume of tissue outside of the inside wall of a target vessel.

[0104] FIG. 3 is a side view of an embodiment of the proximal handle.

[0105] FIG. 4 is a longitudinal cross section of the PFIC showing the addition of a rod in the primary injection lumen of the catheter designed to reduce the dead space within the injection lumen.

[0106] FIGS. 5A and 5B are side views of the embodiment of the proximal handle designed for use with the PFIC which includes the mechanism to adjust the range of vessel diameters that can be treated.

[0107] FIG. 6A is a cross sectional view of an embodiment of the distal portion of the guide tubes and injector tubes with distal needles in the expanded state.

[0108] FIG. 6B is a cross sectional view of an embodiment of the PFIC injector tube designed to work without a separate guide tube for deployment of the injection needle

[0109] FIG. 6C is a cross sectional view of an embodiment of the PFIC that integrates together the guide tube and injector tube into a single extendable arm.

[0110] FIG. 7A is a cross sectional view showing the engagement of the PTAC guide tube with the inside wall of a target vessel.

[0111] FIG. 7B is a cross sectional view showing the engagement of the PFIC with angulated guide tube distal end with the inside wall of a target vessel.

[0112] FIG. 8A is a longitudinal cross section of a central portion of the PTAC showing the three concentric hypotubes.

[0113] FIG. 8B is a longitudinal cross section of a central portion of an embodiment of PFIC showing the three concentric plastic tubes with an integral helically wound flat metal wire.

[0114] FIG. 8C is a longitudinal cross section of a central portion of an embodiment of the PFIC showing flexible connecting tubes between distal and proximal portions of the three concentric hypotubes.

[0115] FIG. 8D is a longitudinal cross section of a central portion of an embodiment of the PFIC showing flexible non-kinking connecting tubes with integral helically wound flat metal wire used to connect distal and proximal portions of three concentric hypotubes.

[0116] FIG. 9 is a schematic view showing the folded PFIC as it might be positioned for packaging.

DETAILED DESCRIPTION

[0117] FIG. 1 is a schematic view of a longitudinal cross-section of a distal portion of the PTAC 100. Certain embodiments and features of the PTAC are disclosed and shown in FIG. 2 of Fischell et al. U.S. Pat. Nos. 9,179,962, 9,254,360, 9,301,795, 9320,850, 9,526,827, 9,539,047, and 9,554,849, incorporated herein by reference. The PTAC 100 is shown in its open position for delivery of fluid into a volume of tissue outside of the inside wall of a target vessel.

[0118] The PTAC 100 includes an outer tube 102, outer tube extension 104 having distal openings 131 through which the guide tubes 115 with radiopaque markers 122 are advanced outward from the outer tube extension 104 of the PTAC 100. Also shown is the tapered section 106 and fixed guide wire 110 with distal tip 109. The injector tubes 116 with distal injection needles 119 and needle distal openings 117 providing fluid egress are shown in their fully deployed positions. The PTAC 100 has three guide tubes with the third tube hidden behind the catheter and not visible in this schematic view. Although the PTAC 100 has three guide tubes 115, it is envisioned that other embodiments could have as few as one or as many as eight guide tubes with an optimum number being three or four. A larger diameter target vessel might suggest the use of as many as 4 to 8 guide tubes 115 with coaxial injector tubes 116.

[0119] Different shapes are envisioned for the distal openings (or windows) 131 in the outer tube extension 104 where the guide tubes 115 exit. These possible shapes include a racetrack design with curved (e.g., round) proximal and distal ends and straight sides in the axial direction, oval or round shapes. It is also envisioned that there could be a movable flap covering the opening 131 or a slit that could be opened to make the outer surface of the PTAC smooth for better delivery into the renal artery.

[0120] An important feature of this catheter is the guide tubes 115 that act as needle guiding elements for the ultra-thin injector tubes 116 with distal injection needles 119. While not shown in FIG. 1 but shown in FIG. 6A, an embodiment can include non-coring needles.

[0121] FIG. 2 is a longitudinal cross-section of the distal portion of the Peri-vascular Tissue Ablation Catheter PTAC 100. Certain embodiments and features of the PTAC are disclosed and shown in FIG. 3 of Fischell et al. U.S. Pat. Nos. 9,179,962, 9,254,360, 9,301,795, 9320,850, 9,526,827, 9,539,047, and 9,554,849, incorporated herein by reference. The proximal end of FIG. 1 shows the three concentric tubes, the outer tube 102, middle tube 103 and inner tube 105 which form the central portion of the PTAC 100. The outer tube 102 is attached to the outer tube extension 104 which is in turn attached to the tapered section 106. The fixed guide wire 110 with core wire 111 and outer layer 113 extends distally from the distal end of the tapered section 106. It should be noted that only part of the length of the guide wire 110 is shown in FIG. 1.

[0122] FIG. 2 shows the guide tube 115 with radiopaque marker 122 in its fully advanced position placed through the opening 131 in the outer tube extension 104. The interior surface of the outer tube extension 104 forms part of the tubular shaft 120 can be made from a stiff material such as a metal or high durometer plastic so that it will be relative rigid as the guide tubes 115 are advanced and retracted.

[0123] An embodiment of the PTAC 100 of the uses four different tubular structures instead of just an outer tube 102 and outer tube extension 104. Specifically, the proximal section of each of the three concentric tubes can be a metal hypotube. The metal hypotube can connect at its distal end to a relatively stiff plastic tube about 20 cm long that can in turn connect to a softer more flexible plastic tube about 10 cm long which can be the tube 102 shown in FIG. 1. FIG. 8A shows a longitudinal cross section of the hypotube section of the PTAC 100.

[0124] In an embodiment, the middle tube 103 attaches to, a proximal metal hypotube and the inner tube 105 can also attach to proximal portion formed from a metal hypotube.

[0125] The central buttress 121 shown in FIG. 2, supports the guide tube 115 both as it is pushed distally and after it is fully deployed. This central buttress 121 also provides radial support for the advanced guide tubes 115 that prevents the guide tubes 115 from backing away from the interior wall of the target vessel as the injector tubes 116 with sharpened needles 119 are advanced through the guide tubes 115 forward into and through the inner/interior wall of the target vessel to their desired position 2-5 mm beyond the inner wall of the target vessel. In exceptional cases, the injection needles 119 at the distal ends of the injector tubes 116 might be advanced as deep as 8 mm beyond the inner wall of the target vessel. Additional lateral support for the guide tubes 115 is provided by the sides of the openings 131 that in combination with the central buttress 121 are key to the radial and circumferential/lateral support both during guide tube 115 advancement, and as backup during delivery of the injection needles 119 through the interior wall of the target vessel. The buttress may comprise a deflection surface such as a curved or linear ramp, which may in a curved embodiment correspond to the radius of curvature of the distal surface of the guide tube 115.

[0126] The inner tube 105 with fluid injection lumen 133 connects through the manifold 125 to the three injector tubes 116, thus the lumens of the injector tubes 116 are in fluid communication with the fluid injection lumen 133. The inner tube 105 and manifold 125 can slide along the longitudinal axis of the PTAC 100 inside of the middle tube 103 which is shown with uniform diameter over its length including the portion coaxially outside of the manifold 125.

[0127] FIG. 3 is a side view of the control handle 200. Certain embodiments and features of the handle are disclosed and described in Fischell et al. U.S. patent application Ser. No. 16/039,234, filed Jul. 18, 2018, incorporated by reference herein, designed for use with the PTAC 100 of FIGS. 1 and 2 or the PFIC embodiments shown in FIGS. 4 through 9. The handle 200 is designed to simplify the operation of the catheter while including appropriate failsafe features.

[0128] The main body 210 of the handle 200 is of relatively rectangular or rounded cross section with beveled or rounded edges where the side surface of the handle 211 meets the bottom of the handle 215. A finger detent 212 improved the comfort of holding the handle 200 and is positioned so that the operators hand is situated to be able to best operate the primary controls of the handle including the unlock button 222, the unlock release button 226 and the slider 224. The slider 224 is an example of a longitudinal movement mechanism that can advance and retract the PTAC 100 guide tubes 115 of FIGS. 1 and 2 with respect to the PTAC 100 catheter body and can also advance and retract the PTAC 100 injector tubes 116 with needles 119 with respect to the guide tubes 115.

[0129] The unlock button 222 has locked (up) and unlocked (down) states. When depressed and released the unlock button 222 will stay in the unlocked (down) state and will allow longitudinal motion of the slider 224. If the operator depresses the unlock button 222 in error and wishes to pop it back up returning it to the locked (up) state, this can be accomplished by depressing the unlock release button 226.

[0130] The upper side of the handle 200 includes a rounded or beveled surface 208. A relock button 226 is also placed on the top of the handle 200.

[0131] Distal to the main body 210 is a tapered section 206, and distal to that is a strain relief 204 which is outside of the outer hypotube 102 seen for the PTAC 100 of FIG. 8A.

[0132] Proximal to the main body 210 is the 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 it may be 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 PTAC 100 of FIG. 2. A flushing tube 252 with Luer connector 254 is in fluid communication with two spaces: 1) the space between the inner tube 105 and middle tube 103 of FIG. 2 and 2) the space between the middle tube 103 and outer tube 102 shown in FIG. 2 and used to flush the catheter with saline to remove any air that might get into the patient's blood vessels before operation of the PTAC 100.

[0133] FIG. 4 shows a longitudinal cross sectional view of the PFIC 150. The PFIC 150 is a modified version of the PTAC of FIG. 2 with the changes including a specification of radius of curvature R for the injector tube 156 with distal needle 159, radiopaque wire 151 and fluid egress 157 replacing the injector tube 116 of FIG. 2 and the addition of an inserted flexible rod 152 inside of the lumen 133 of the inner tube 105. The radius of curvature R of the injector tube 156 with distal needle 119 can be between 0.05″ and 0.15″ so that the needles will have sufficient curve to match the curvature of the guide tube 115 but not curve back so much the fluid egress 157 does not properly in the peri-vascular space. The radius of curvature can be between 0.10″ and 0.12″.

[0134] The purpose of the rod 152 that can extend into the proximal portion of the PFIC 150 is to take up volume within the lumen 133 and the lumens 93, 733, 833 and 933 of the inner hypotubes 82, 702, 802 and 902 shown in FIGS. 8A though 8D to reduce the dead space in the primary injection lumen of the PFIC 150 that runs along the proximal and central sections of the catheter. It is envisioned that the rod 152 can be highly flexible so as not to affect the overall flexibility of the PFIC 150 proximal and central portions. While shown here as a solid rod, a hollow tube with closed ends could be used to increase flexibility. Ideally whether solid or tubular, the rod 152 can be formed from a low durometer plastic, that may be for example, Urethane, Tecothane or Pebax. The other element numbers of FIG. 4 are unchanged from those in the detailed description associated with FIG. 2 of this specification.

[0135] The catheter can include an outer surface. The catheter can include a central axis extending in a longitudinal direction and three concentric tubular structures, an outer tube, a middle tube and an inner tube. The inner tube structure can have a fluid injection lumen. The catheter can include at least two guide tubes adapted to advance distally and expand outwardly toward the interior wall of the target vessel. The catheter can include a mechanical support structure including a deflection surface, the deflection surface deflecting the distally moving guide tubes radially outward from the outer surface of the distal portion of the catheter body. The catheter can include at least two injector tubes with distal injection needles each having an injection lumen in fluid communication with the fluid injection lumen of the catheter body. The at least two injector tubes with distal injection needles are adapted to be advanced outwardly, guided by the at least two guide tubes to penetrate the interior wall of the target vessel. The injection needles can have a distal opening for fluid delivery into the tissue outside of the interior wall of the target vessel. The catheter can have three guide tubes. At least one needle can be hollow and includes fluid egress near the distal end of the needle, with the catheter having an injection lumen in fluid communication with the fluid egress of the at least one needle.

[0136] The catheter can include a rod positioned within the inner tube, the rod adapted to reduce the volume within the inner tube by at least 50%. The rod can reduce the volume within the inner tube by 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or any range of the forgoing values. The rod can reduce the volume of the fluid within the catheter including all fluid pathways by 50%, 55%, 60% 0, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or any range of the forgoing values. The rod can minimize dead space within the catheter, which is advantageous when injecting ablative agents. The rod can reduce the dead space/internal volume in the catheter injection lumen. The rod can increase the resistance to flow which can beneficially slow down the rate of infusion.

[0137] Reducing the internal volume of the catheter minimizes the amount of saline needed to flush the ablative fluid out of the catheter into the desired volume of tissue. The dead space can be less than 0.5 ml and in some cases less than 0.2 ml. In some embodiments, dead space can be reduced to less than 0.1 ml. The inner tube can be a small diameter such as less than 0.5 mm inner diameter for fluid injection. The rod can be placed along the entire inner tube, or a portion thereof, to reduce the volume of the hypotube and thus reduce the catheter dead space. In some embodiments, the total internal volume or dead space from a proximal part to a distal end of an infusion flow path of the catheter is 0.5 ml, 0.4 ml, 0.3 ml, 0.2 ml, 0.1 ml, or any range of the foregoing values.

[0138] In some embodiments, the rod equalizes the flow rate between two or more injector tubes. In some embodiments, the rod equalizes the pressure between two or more injector tubes. In some embodiments, the rod equalizes the flow volume between two or more injector tubes. The rod can be centered within the catheter. The rod can be off-centered with the catheter. The rod can equally obstruct the flow for all flow paths to the needles. The rod can have a circular cross section. The rod can be other cross-sections including oval or polygonal. The rod can be hollow inside. The rod can be solid. The rod can be flexible. The rod can be radiopaque. The rod can be radio translucent.

[0139] The catheter can further include a wire placed in each injection needle to reduce the volume within the injection needle. The wire can be radiopaque. The wires can be formed from a material including gold, platinum, tantalum, iridium, and/or tungsten filled urethane plastic. In addition to providing better visibility, the radiopaque wire in the lumen of each injector tube reduces the internal volume or dead space within the injector tube. The rod can be separate from the wire. The rod and the wire can be separate materials. The rod and the wire can be the same material. In some embodiments, the rod and the wires are integrally formed.

[0140] Another potential feature of the PFIC 150 is that it is envisioned that the plastic used to form the guide tube 115 may be formed from a plastic impregnated with radiopaque particles such as tungsten filled urethane. This can eliminate the need for the radiopaque band 122.

[0141] FIGS. 5A and 5B show the PFIC handle 300 which is a modification of the handle 200 of FIG. 3. The additions to the handle 200 include: [0142] 1. a check valve 310 integrated into the proximal connector 302 which is the fluid port for infusion of the fluid that will egress through the opening 117 in the injection needles 119 of FIG. 4. The check valve provides the advantage of preventing blood from flowing back through the primary infusion lumen 133 of FIG. 4, [0143] 2. a vessel size selection mechanism 320 including the slider 350 and vessel range markers 353 for larger vessels and 352 for smaller vessels. The markers 352 and 353 as shown in FIG. 5A include labels 355 and 356 respectively showing the vessel range where the larger vessel range marker is shown with a label 356 of 4-7 mm and the smaller vessel range marker with a label 355 of 2-4 mm. The slider 350 of FIG. 5A is shown in the position for the smaller range of vessels 352/355. The slider 350′ of the mechanism 320′ of FIG. 5B is shown in the position for the larger range of vessels 353/356. [0144] 3. an optional marker band 325 on the outer tube 82 which also indicates the relative longitudinal position of the outer tube 102 to the tapered sections 204 and 206 fixed to the outer case 211 of the handle 300.

[0145] The check valve 310 can be located in the proximal handle. The proximal handle can have an injection port in fluid communication with the catheter fluid injection lumen. The injection port can include the check valve 310. The proximal handle is further adapted to advance and retract the guide tubes and needles as described herein. In some embodiments, the check valve 310 can be located anywhere along the catheter fluid injection lumen. The check valve 310 can be located in fluid communication with any fluid pathway through the catheter. The catheter fluid injection lumen can be in fluid communication with the fluid egress of the at least one needle. The catheter fluid injection lumen can be in fluid communication with the fluid egresses of the at least three needles. The catheter fluid injection lumen can be in fluid communication with at least one hollow needle. The fluid egress can be ear the distal end of the needle. In some embodiments, the check valve 310 is positioned near the proximal end of the fluid injection lumen. In some embodiments, the check valve is located at the proximal end of the catheter body. The catheter body has an injection port at the proximal end of the fluid injection lumen and the check valve is attached to proximal end of the injection port. In some embodiments, the check valve is integral to the proximal portion of the fluid injection lumen.

[0146] In some embodiments, the at least one guide tube outwardly expandable a radial distance of at least 0.5 millimeter beyond an outer surface of the catheter body with the distal end in proximity to the inside wall of the target vessel. In some embodiments, the at least one guide tube outwardly expandable a radial distance of 0.5 millimeter, 0.6 millimeter, 0.7 millimeter, 0.8 millimeter, 0.9 millimeter, 1.0 millimeter, 1.1 millimeter, 1.2 millimeter, 1.3 millimeter, 1.4 millimeter, 1.5 millimeter, or any range of the foregoing valves. The proximal handle having a top surface, two side surfaces and a bottom surface is adapted to advance and retract the guide tubes and needles as described herein. The handle can include an unlock mechanism having a locked state and an unlocked state. The handle can include a movement mechanism designed to allow the relative longitudinal movement of the at least one guide tube with respect to the catheter body and the at least one needle with respect to the at least one guide tube. The handle including a mechanism to adjust the radial distance to which the at least one guide tube is outwardly expandable.

[0147] The at least one needle can include a fluid egress near the distal end of the needle. The at least one needle can have a distal end that forms an electrode. The catheter body further including a wire that runs the length of the catheter to conduct electrical signals between the at least one electrode and connecting means near the proximal end of the catheter. The conducting means adapted to connect the wire to external equipment. The external equipment includes electronic systems can include a means to measure electrical signals, a means to measure electrical signals sensed by the electrodes of the at least one needle, a means to provide electrical stimulation signals to the electrodes of the at least one needle, and/or a means to provide energy based ablation through the electrodes of the at least on needle.

[0148] The mechanism to adjust the radial distance to which the at least one guide tube is outwardly expandable has at least two pre-set selectable settings. In some embodiments, there are 3 or more pre-set selectable settings. In some embodiments, the mechanism is a slider. The slider can slide between two positions. The two positions can be labeled with words such as the diameter size and/or icons showing a larger expansion and a smaller expansion. The user can slide the mechanism to select between at least two pre-set settings for the radial distance. In some embodiments, the first pre-set setting is 0.5 millimeter, 1.0 millimeter, 1.5 millimeter, 2.0 millimeter, 2.5 millimeter, 3.0 millimeter, 3.5 millimeter, 4.0 millimeter, 4.5 millimeter, 5.0 millimeter, 5.5 millimeter, 6.0 millimeter, 6.5 millimeter, 7.0 millimeter, or any range of the foregoing valves.

[0149] In some embodiments, the second pre-set setting is 0.5 millimeter, 1.0 millimeter, 1.5 millimeter, 2.0 millimeter, 2.5 millimeter, 3.0 millimeter, 3.5 millimeter, 4.0 millimeter, 4.5 millimeter, 5.0 millimeter, 5.5 millimeter, 6.0 millimeter, 6.5 millimeter, 7.0 millimeter, or any range of the foregoing valves, or any range of the foregoing valves. In some embodiments, the first pre-set setting is between 2 millimeter and 4 millimeter. In some embodiments, the second pre-set setting is between 4 millimeter and 7 millimeter.

[0150] The proximal handle can include at least one label associated with the state of the catheter. The label can indicate the position of the movement mechanism where the at least one guide tube and at least one injector tubes are both retracted. The label can indicate the position of the movement mechanism where the at least one guide tube is advanced but the at least one injector tube is retracted. The label can indicate the position of the movement mechanism where the at least one guide tube and at least one injector tube are both advanced. The label can indicate the position of the mechanism to adjust the radial distance to which the at least one guide tube is outwardly expandable. The proximal handle can includes a graphic icon associated with one or more label. The label associated with the position of the mechanism to adjust the radial distance to which the at least one guide tube is outwardly expandable can include a text label, a circular icon, and/or a text label and a circular icon

[0151] The mechanism can adjust the pre-set radial distance from the outer surface of the distal portion of the catheter body to which the at least two guide tubes move outward. The mechanism can adjust the pre-set radial distance of three guide tubes. The mechanism can adjust the pre-set radial distance of all of the guide tubes simultaneously.

[0152] The method of use can include advancing into the vessel the catheter as described herein. The method can include determining the diameter of the vessel to be treated. The diameter of the vessel can be determined before advancing the catheter or while the catheter is within the patient. The user can use the mechanism to adjust the radial distance to which the at least one guide tube is outwardly expandable with respect to the catheter body to select an appropriate radial distance for the measured vessel diameter. The mechanism can be adjusted before advancing the catheter or while the catheter is within the patient.

[0153] The method of use can include operating the longitudinal movement mechanism to advance a pre-set distance at least one guide tube away from the catheter body until the distal end of the at least one guide tube is in proximity to the inside wall of the vessel. The pre-set distance can be determined by the mechanism that adjusts the radial distance. The mechanism to adjust the radial distance to which the at least one guide tube is outwardly expandable with respect to the catheter body has at least two preset selectable settings. The method of use can include operating the longitudinal movement mechanism to extend the at least one injector tube a preset distance beyond the distal end of at least one guide tube, causing the at least one injector tube to penetrate through the inside wall of the target vessel placing the fluid egress of the at least one needle into a volume of tissue outside of the inside wall of the target vessel.

[0154] The method of use can include attaching a fluid source to the catheter. The fluid source can be a vial of ablative fluid provided in a kit with the catheter. The kit can include a syringe for injecting the fluid. The syringe can inject fluid into a port and through the check valve. The method of use can include injecting fluid through the catheter injection lumen and out of the needle fluid egress into a volume of tissue outside of the inside wall of the vessel. In some methods, the needles inject fluid. In some methods, the needles are distal electrodes.

[0155] The internal mechanism to make the adjustment for vessel size function in the handle 300 requires that the slider 350 control the longitudinal movement of the outer tube 82 with respect to the tapered section 204. When the slider 350 is in the small vessel distal position as shown in FIG. 5A, the outer tube 82 sits in a more distal position as seen with the marker band 325 so the guide tubes 115 of FIG. 4 will be more retracted proximally from the openings 131 in the outer body of the PFIC 150 of FIG. 4. Since the guide tubes 115 start further back proximally, with the same relative advancement of the slider 224 that controls the longitudinal movement of the guide tubes 115 with respect to the opening 131, the guide tubes 115 will not extend as far out of the opening 131. Because only the outer tube 82 is affected, the injector tube 116 with distal needles 119 will still extend the same about beyond the distal end of the guide tubes 115.

[0156] It is also envisioned that rather than a slider 350, a lock/unlock button (not shown) could be added to the handle 200 of FIG. 3 that in an unlocked configuration allows the outer tube 82 to be moved longitudinally with respect to the tapered section 204 and when released, will lock the outer tube 82 position with respect to the tapered section 204. The actual total distance that the outer tube 82 would need to move longitudinally to accommodate two ranges can be between 1 and 4 mm with a some embodiments having a distance of 2-3 mm.

[0157] FIG. 6A is a cross sectional view of the distal portion of the PTAC 300 guide tube 315 and injector tubes 316 with distal non coring needles 319 in the expanded state. The guide tube 315 with distal end 325 includes an inner layer 323, outer layer 324 and radiopaque marker band 322. The injector tube 316 includes a radiopaque wire 311 and distal fluid egress 317.

[0158] FIG. 6B is a cross sectional view of an embodiment of the PFIC 400 injector tube 416 with distal needle 419 designed to function as a single expandable arm 410 without a separate guide tube for deployment of the injection needle 419. The injector tube 416 includes a radiopaque wire 411 and distal fluid egress 417. The injector tube further has a widened section 415, with distal end 425 and radiopaque band 422. One can envision the injector tube 416 with widened section 415 being expanded outward from the body of the PFIC 400 through openings similar to the opening 131 shown in FIG. 4 for the PFIC 150. The tapered shape of the widened section 415 allows the injector tube 416 with widened section 415 to easily slide back into the openings 131 of FIG. 4 when the injector tubes 116 are retracted back into the outer tube extension 104 of the PFIC 400.

[0159] The PFIC 400 can have a simpler operation than the PFIC 150 of FIG. 4 as rather than advancing guide tubes 115 then injector tube/needles 116/119 there is only one element to advance outward. In this embodiment of the PFIC 400 it is envisioned that the wall thickness of the injector tube 416 can be uniform as shown in FIG. 6B or could be thicker in the section proximal to the distal end 425 of the thickened section 422 to strengthen it. The material for the injector tube 416 can be a memory metal such as NITINOL. The widened section 415 can be formed from a plastic of relatively low durometer making the distal end 425 soft enough to not cause damage to the inside wall of the target vessel when it engages the wall. The widened section 415 can optionally have a hydrophilic coating to make the widened section 415 slide easily through the openings 131 of FIG. 4.

[0160] The radiopaque band 422 and wire 411 can be formed of a radiopaque material such as gold, tantalum or platinum. It is also envisioned that the widened section 422 could be formed from an impregnated plastic such as tungsten filled urethane that can by itself be radiopaque and eliminate the need for the radiopaque band 422.

[0161] FIG. 6C is a cross sectional view of an embodiment of the PFIC 500 that integrates together the guide tube and injector tube of the PTAC 300 into a single arm 510 designed to function as a single expandable element without a separate guide tube for deployment of the injection needle 519. The arm 510 has a proximal tubular section 515 with inner layer 523 with lumen 513, outer layer 524 and radiopaque band 533 placed around the outer layer 524. The arm 510 has a distal injector tube section 516 that includes a lumen 521 with radiopaque wire 511 and distal fluid egress 517. The wire 511 is connected to the proximal end of distal injector tube section 516 with a weld 512. Instead of a weld, other means of attachment are envisioned including the use of a solder joint or adhesive.

[0162] The injector tube section 516 proximal portion is attached coaxially inside the distal portion of the inner layer 523 of the tube 515. One can envision the arm 510 being expanded outward from the body of the PFIC 500 through openings similar to the opening 131 shown in FIG. 4 for the PFIC 150. The PFIC 500 can have a simpler operation than the PFIC 150 of FIG. 4 as rather than advancing guide tubes 115 then injector tube/needles 116/119 there is only one element, the arm 510 to advance outward. The material for the injector tube 516 can be a memory metal such as NITINOL. The tubular section 515 can be formed either from a memory metal such as NITINOL or from a plastic material. The radiopaque band 522 and wire 511 can be formed of a radiopaque material such as gold, tantalum or platinum. It is also envisioned that either or both inner layer 523 or outer layer 524 of the tubular section 515 could be formed from an impregnated plastic such as tungsten filled urethane that can by itself be radiopaque and eliminate the need for the radiopaque band 522.

[0163] The lumen 513 of the inner layer 523 is in fluid communication with a fluid injection lumen similar to the lumen 133 of the PFIC 150 of FIG. 4. The lumen 513 is also in fluid communication with the lumen 521 of the injector tube section 516 which lumen 521 is in fluid communication with the fluid egress 517.

[0164] FIG. 7A is a cross sectional view showing the engagement of the distal end 325 of the PTAC 300 guide tube 315 with the inside wall of a target vessel for a vessel smaller than the maximum range of vessels for the PTAC 300. Because of the limitation of proposed radii of curvature for the injector tube 316, the design of the PTAC 300 is constrained if the plane intersecting the distal end 325 of the guide tube 315 is perpendicular to the axis of the guide tube. The angle A shows the angle of the distal end 325 of the guide tube 315 with respect to the inside wall of the target vessel. If the PTAC 300 is designed to have the angle A be zero degrees at the maximum allowable diameter vessel diameter, then for smaller vessels as demonstrated by FIG. 7A, the engagement will produce an angle greater than zero degrees. This can be a particular issue for a PFIC designed to operate in 2 or more vessel ranges.

[0165] FIG. 7B is a cross sectional view showing the engagement of the PFIC 600 with guide tube 615 having angulated distal end 625 designed to perform better over a wider range of vessel sizes for use either in a small vessel version of the PFIC 600 that engages with the inside wall of a target vessel. The PFIC 600 is shown with the plane intersecting the distal end 625 of the guide tube 615 having an angle B with respect to the plane perpendicular to the longitudinal axis of the guide tube 615. This angulated distal end 625 may perform better over a wider range of vessel sizes than the non-angulated distal end 325 of the PTAC 300. The angle B can be between 5 degrees and 45 degrees.

[0166] It is also envisioned that instead of a dual range version of the PFIC 600, the angulated guide tube 615 could be utilized for a single range small vessel implementation where the only 2 changes required from the PTAC 300 of FIG. 7A using the handle 200 of FIG. 3, are: [0167] 1. lengthening of the outer tube 82 of FIG. 3 to position the guide tubes 615 further back in the body of the catheter so they do not extend as far when advanced beyond the openings 131 and [0168] 2. using the angulated guide tube 615 so that the angle of engagement with the inside wall of the target vessel B is closer to zero degrees than if one used the guide tube 315 of FIG. 7A designed for a larger range of vessel sizes.

[0169] The PFIC embodiments 400, 500 and 600 can be packaged in their deployed configuration so as to help avoid resetting the proper radius of curvature for the plastic components such as the tube 515 of FIG. 6C and the guide tube 615 of FIG. 7B.

[0170] FIG. 8A is a longitudinal cross section of a central portion of the PTAC 100 showing the three concentric hypotubes, the inner tube 85 with lumen 93, the middle tube 83 and outer tube 82. While there is an advantage in using metal hypotubes because of their strength and pushability, such metal tubes in the PTAC 100 may require the device be packaged as in a straight configuration making the device package more than a meter in length which means it cannot be easily stored on a shelf. Long package length can be even more of a problem for a radial artery access version that is typically more than 20 cm longer than a femoral access version of the PTAC 100.

[0171] While the inner tube 85 must remain as a sealed tube for fluid delivery, it is envisioned that adding holes or slots (e.g. by laser cutting) in the outer and middle tubes 82 and 83 could significantly increase the overall flexibility of the central section of the catheter while maintaining good pushability.

[0172] FIG. 8B is a longitudinal cross section of a central portion of an embodiment of PFIC 700 showing the three concentric tubes, an inner tube 705 with fluid injection lumen 733, a middle tube 703 and an outer tube 702. The tubes 702, 703 and 705 are composed a plastic with an integral helically wound flat metal wire. The outer tube 702 has flat wire helix 722, the middle tube 703 has flat wire helix 723 and the inner tube has flat metal wire helix 725. Certain features and uses of helical wound flat wire impregnated tubing is described in Fischell et al. U.S. Pat. No. 8,591,495, issued Aug. 24, 2011; U.S. Pat. No. 8,248,925, issued Jan. 19, 2016; U.S. Pat. No. 5,180,376, issued Jan. 19, 1993; U.S. Pat. No. 5,423,774, issued Jun. 13, 1995, and U.S. Pat. No. 5,484,425, issued Jan. 16, 1996, which are hereby incorporated by reference in their entirety. The use of such tubing here is advantageous as it can allow the PFIC 700 to be packaged in a spiral configuration similar to many existing catheters to fit in a relatively small dimensioned package that could be placed on a shelf.

[0173] It is also envisioned that only one or two of the three tubes be formed from a helical wire braided tube and the other could remain as metal hypotubes. It is also envisioned that instead of helical flat wires impregnating the tubes, a wire braid such as that used in guiding catheters could provide for a flexible but pushable tube for use in the PFIC. In any of these configurations, the PFIC 700 can be packaged when wound in a spiral as are many interventional cardiology products such as angioplasty balloons.

[0174] FIG. 8C is a longitudinal cross section of a central portion of an embodiment of the PFIC 800 showing metal hypotubes 502P, 802D, 803P, 803D, 805P and 805D flexible connecting tubes 802, 813 and 815 including an inner connecting tube 815, a middle connecting tube 813 and an outer connecting tube 812. The outer connecting tube 812 provides a flexible connection between the proximal outer hypotube 802P and the distal outer hypotube 802D. The middle connecting tube 813 provides a flexible connection between the proximal middle hypotube 803P and the distal middle hypotube 803D. The inner connecting tube 815 provides a flexible connection between the proximal inner hypotube 805P and the distal inner hypotube 805D. It is important that the inner connecting tube 815 provide a fluid seal so that fluid injected into the injection lumen 833 will flow without leaking from the inner proximal hypotube 805P through the inner connecting tube 815 into the distal inner hypotube 805D. A perfect seal is less important for the inner and outer tubes and it is envisioned that instead of connecting the proximal and distal section of middle and outer tube with a connecting tube one or more wires could be welded to provide a flexible but pushable link between the proximal and distal sections of the middle and outer tubes. This also applies to the PFIC 900 of FIG. 8D

[0175] In one embodiment the connecting tubes 812, 813, and 815 are formed from a low durometer plastic and several such flexible connectors could be placed along the length of the PFIC 800 to allow it to be placed in a package where it is wound in a spiral as are many interventional cardiology products such as angioplasty balloons. Instead of plastic connecting tubes it is also envisioned that a memory metal such as NITINOL which is non-kinking and extremely flexible could be used for the connecting tubes. As with the PFIC 700 in FIG. 8B, it is envisioned that one or two of the metal hypotubes might remain as metal with only one being split with a flexible connector between proximal and distal sections.

[0176] FIG. 8D is a longitudinal cross section of a central portion of an embodiment of the PFIC 900 showing flexible connecting tubes 912, 913 and 915 with integral helical flat wires similar to the tubes 702, 703 and 705 of FIG. 8B. Specifically, these are an inner connecting tube 915 with flat wire helix 925, a middle connecting tube 913 with flat wire helix 923 and an outer connecting tube 912 with flat wire helix 922. The outer connecting tube 912 provides a flexible connection between the proximal outer hypotube 902P and the distal outer hypotube 902D. The middle connecting tube 913 provides a flexible connection between the proximal middle hypotube 903P and the distal middle hypotube 903D. The inner connecting tube 915 provides a flexible connection between the proximal inner hypotube 905P and the distal inner hypotube 905D. It is important that the inner connecting tube 915 provide a fluid seal so that fluid injected into the injection lumen 933 will flow with leaking from the inner proximal hypotube 905P through the inner connecting tube 915 into the distal inner hypotube 905D.

[0177] Certain embodiments are taught in the Fischell et al. U.S. Pat. No. 8,591,495, issued Aug. 24, 2011; U.S. Pat. No. 8,248,925, issued Jan. 19, 2016; U.S. Pat. No. 5,180,376, issued Jan. 19, 1993; U.S. Pat. No. 5,423,774, issued Jun. 13, 1995; and U.S. Pat. No. 5,484,425, issued Jan. 16, 1996, incorporated by reference herein. Tubing with a flat wire helix will resist kinking and it is envisioned that having a single set of connecting tubes 912, 913 and 915 of sufficient length could allow the PFIC 900 to be bent in half as seen in FIG. 9 for packaging into a box approximately half the length of certain embodiments of the PTAC 100 which uses three metal hypotubes.

[0178] As with the PFIC 700 in FIG. 8B, it is envisioned that one or two of the flexible connecting tubes 912, 912 and 915 might be omitted and the entire length remain as a metal hypotube. It is also envisioned that a wire braid such as is used in guiding catheters could replace the helically wound flat wires 922, 923 and 925 of the tubes 912, 913 and 915 to provide flexibility.

[0179] FIG. 9 is a schematic view showing the folded PFIC 900 as it might be positioned for packaging. The PFIC 900 has a handle 950 that can be based on either the handle 200 of FIG. 3 or the PFIC 300 dual range handle 210 of FIGS. 5A and 5B. The distal portion 920 of the PFIC 900 may be similar to the distal portion of the PTAC 100 of FIGS. 1 and 2 or it may include any of the features of the PTAC 300 of FIG. 6A or the PFIC 150, 400, 500, or 600 of FIGS. 4, 6B, 6C and 7B.

[0180] The majority of the length of the PFIC 900 comprises the proximal outer hypotube 902P and the distal outer hypotube 902D. These are connected to each other as shown in FIG. 8D with the outer flexible connecting tube 912. The middle connecting tube 913 and inner connecting tube 915 are internal to the catheter and not visible in this view.

[0181] Various other modifications, adaptations, and alternative designs are, of course, possible in light of the above teachings. Therefore, it should be understood at this time that within the scope of the appended claims may be practiced otherwise than as specifically described herein.

[0182] While this specification has focused on use of the PFIC for use in ablation of tissue, it is also clearly envisioned that the apparatus and methods of FIGS. 1-9 inclusive can be applied to inject any fluid for any purpose including that of local drug delivery into a specified portion of a blood vessel or the volume of tissue just outside of a blood vessel, or into prostatic tissue via the prostatic urethra.

[0183] While the embodiments shown in FIGS. 1-9 show three injection needles, the presently disclosed structure which includes radial and/or lateral support mechanisms for needle guiding elements that guide injection needles as they penetrate the interior wall of a target vessel can be applied to designs with one needle, two needles or 5 or more needles.

[0184] It is contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments disclosed above may be made and still fall within one or more of the embodiments. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with an embodiment can be used in all other embodiments set forth herein. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed embodiments. Thus, it is intended that the scope of the present embodiments herein disclosed should not be limited by the particular disclosed embodiments described above. Moreover, while the embodiments are susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the embodiments are not to be limited to the particular forms or methods disclosed, but to the contrary, the embodiments are to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “expanding a balloon” include “instructing the expanding of a balloon.” The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “approximately”, “about”, and “substantially” as used herein include the recited numbers (e.g., about 10%=10%), and also represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount.