US20130053792A1 - Expandable catheter system for vessel wall injection and muscle and nerve fiber ablation - Google Patents

Expandable catheter system for vessel wall injection and muscle and nerve fiber ablation Download PDF

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Publication number
US20130053792A1
US20130053792A1 US13/294,439 US201113294439A US2013053792A1 US 20130053792 A1 US20130053792 A1 US 20130053792A1 US 201113294439 A US201113294439 A US 201113294439A US 2013053792 A1 US2013053792 A1 US 2013053792A1
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United States
Prior art keywords
injection
distal
fluid
sheath
inas
Prior art date
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Abandoned
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US13/294,439
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English (en)
Inventor
David R. Fischell
Tim A. Fischell
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Ablative Solutions Inc
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Ablative Solutions Inc
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Publication date
Priority claimed from US13/216,495 external-priority patent/US9278196B2/en
Priority to US13/294,439 priority Critical patent/US20130053792A1/en
Application filed by Ablative Solutions Inc filed Critical Ablative Solutions Inc
Assigned to ABLATIVE SOLUTIONS, INC. reassignment ABLATIVE SOLUTIONS, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: FISCHELL, DAVID R., FISCHELL, TIM A.
Priority to US13/342,521 priority patent/US9056185B2/en
Priority to PCT/US2012/051906 priority patent/WO2013028781A1/en
Priority to CN201711417679.4A priority patent/CN107899126B/zh
Priority to CN201280051666.9A priority patent/CN103974670B/zh
Priority to SG11201400138YA priority patent/SG11201400138YA/en
Priority to HK15101344.4A priority patent/HK1202399B/xx
Priority to JP2014527272A priority patent/JP6266516B2/ja
Priority to US13/643,065 priority patent/US10576246B2/en
Priority to EP12826228.4A priority patent/EP2747688B1/en
Publication of US20130053792A1 publication Critical patent/US20130053792A1/en
Priority to US13/835,556 priority patent/US20130274674A1/en
Priority to US13/835,221 priority patent/US20130274673A1/en
Priority to US14/738,776 priority patent/US10118004B2/en
Priority to JP2017149730A priority patent/JP6932037B2/ja
Priority to US15/917,532 priority patent/US10485951B2/en
Priority to US16/178,940 priority patent/US11007329B2/en
Priority to JP2019204891A priority patent/JP7482616B2/ja
Priority to US16/689,604 priority patent/US11752303B2/en
Priority to US16/805,033 priority patent/US11759608B2/en
Priority to US17/232,695 priority patent/US20210290860A1/en
Priority to US18/449,528 priority patent/US20240033479A1/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A61M25/0084—Catheter tip comprising a tool being one or more injection needles
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    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
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    • A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
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    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
    • A—HUMAN NECESSITIES
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    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
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    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/0039—Multi-lumen catheters with stationary elements characterized by lumina being arranged coaxially
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A61M25/0084—Catheter tip comprising a tool being one or more injection needles
    • A61M2025/0085—Multiple injection needles protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
    • A61M2025/0086—Multiple injection needles protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip the needles having bent tips, i.e. the needle distal tips are angled in relation to the longitudinal axis of the catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A61M25/0084—Catheter tip comprising a tool being one or more injection needles
    • A61M2025/0087—Multiple injection needles protruding laterally from the distal tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M2025/0681—Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0468—Liquids non-physiological
    • A—HUMAN NECESSITIES
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    • A61M2210/00—Anatomical parts of the body
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    • A—HUMAN NECESSITIES
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/0097—Catheters; Hollow probes characterised by the hub

Definitions

  • This invention is in the field of devices to ablate muscle cells and nerve fibers for the treatment of cardiac arrhythmias, hypertension, congestive heart failure and other disorders.
  • target wall will refer here to either the wall of the left atrium surrounding a pulmonary vein or the wall of a pulmonary vein near its ostium for AF ablation applications or the wall of the aorta around the ostium of the renal artery, or within the renal artery itself, for hypertension or congestive heart failure (CHF) applications.
  • CHF congestive heart failure
  • the currently used system for RF energy delivery also does not allow for efficient circumferential ablation of the renal sympathetic nerve fibers. If circumferential RF energy were applied in a ring segment from within the renal artery (energy applied at intimal surface to kill nerves in the outer adventitial layer) this could lead to even higher risks of renal artery stenosis from the circumferential and transmural thermal injury to the intima, media and adventitia. Finally, the “burning” or the inside of the renal artery using RF ablation can be extremely painful. Thus, there are numerous and substantial limitations of the current approach using RF-based renal sympathetic denervation.
  • the Bullfrog® micro infusion catheter described by Seward et al in U.S. Pat. Nos. 6,547,803 and 7,666,163 which uses an inflatable elastic balloon to expand a single needle against the wall of a blood vessel could be used for the injection of an chemical ablative solution such as alcohol but it would require multiple applications as it does not describe or anticipate the circumferential delivery of an ablative substance around the entire circumference of the vessel.
  • the most number of needles shown by Seward is two and the two needle version of the Bullfrog® would be hard to miniaturize to fit through a small guiding catheter to be used in a renal artery.
  • Jacobson and Davis in U.S. Pat. No. 6,302,870 describe a catheter for medication injection into the inside wall of a blood vessel. While Jacobson includes the concept of multiple needles expanding outward, each with a hilt to limit penetration of the needle into the wall of the vessel, his design depends on rotation of the tube having the needle at its distal end to allow it to get into an outward curving shape.
  • the hilt design shown of a small disk attached a short distance proximal to the needle distal end has a fixed diameter which will increase the total diameter of the device by at least twice the diameter of the hilt so that if the hilt is large enough in diameter to stop penetration of the needle, it will significantly add to the diameter of the device.
  • the length of the needed catheter would make control of such rotation difficult.
  • the hilts which limit penetration are a fixed distance from the distal end of the needles. There is no built in adjustment on penetration depth which may be important if one wishes to selectively target a specific layer in the blood vessel or if one needs to penetrate all the way through to the volume past the adventitia in vessels with different wall thicknesses. Jacobson also does not envision use of the injection catheter for denervation.
  • Jacobson in FIG. 3 when he shows a sheath over expandable needles there is no guide wire and the sheath has an open distal end which makes advancement through the vascular system more difficult. Also the needles if they were withdrawn completely inside of the sheath they could because of the hilts, get stuck inside the sheath and be difficult to push out.
  • the present invention Intravascular Nerve Ablation System (INAS) is capable of applying an ablative fluid to produce circumferential damage in the nerve tissue that is in or near the wall of a blood vessel with a relatively short treatment time using a disposable catheter and requiring no additional capital equipment.
  • INAS Intravascular Nerve Ablation System
  • the primary focus of use of INAS is in the treatment of cardiac arrhythmias, hypertension and congestive heart failure.
  • the present invention is designed to provide a more uniform circumferential injury to the nerves, while minimizing injury to the intima and medial layers of the vessel wall.
  • circumferential delivery is defined here as at least three points of simultaneous injection of a suitable ablative solution within a vessel wall, or circumferential filling of the space outside of the adventitial layer (outer wall) of a blood vessel.
  • the present invention does not depend upon rotation of a tube to create outward movement nor does it have a fixed diameter hilt to limit penetration.
  • This type of system may also have major advantages over other current technologies by allowing highly efficient, and reproducible circumferential ablation of the muscle fibers and conductive tissue in the left atrium, surrounding the ostium of the pulmonary veins or in the wall of the pulmonary veins near or at their ostium into the left atrium of the heart. Such ablation could interrupt atrial fibrillation (AF) and other cardiac arrhythmias. Other potential applications of this approach may evolve.
  • AF atrial fibrillation
  • the present invention is a small ( ⁇ 2 mm diameter) catheter, which includes multiple expandable injector tubes, or guide tubes to allow passage of coaxial injector tubes, arranged circumferentially around the body of the INAS near its distal end.
  • Each injector tube includes a needle at its distal end. Ablative fluid could be injected through the distal end of this needle which has injection egress through its distal end or through side holes placed just proximal to its distal end, needle has a (solid tipped) cutting distal end.
  • There is a penetration limiting member as part of the INAS so that the needles will only penetrate into the tissue of the wall of the target blood vessel to a preset distance.
  • self-expanding guiding tubes are first deployed against the inside wall of the renal artery and act as a guide for separate coaxially longitudinally moveable injector tubes with sharpened needles with injection egress port(s) near the distal end.
  • the penetration limiting function of the present invention INAS as described herein uses one of the following techniques that will greatly reduce the diameter of the device as compared with the Jacobson designs of U.S. Pat. No. 6,302,870 and thus also improve the ability to deliver it into a vessel of a human body such as the renal artery. These techniques include:
  • the injector tubes with distal needles are in fluid communication with an injection lumen in the catheter body, which is in fluid communication with an injection port at the proximal end of the INAS.
  • an injection port would typically include a standard connector such as a Luer connector used to connect to a source of ablative fluid.
  • This injection system also anticipates the use of very small gauge needles (smaller than 25 gauge) to penetrate the arterial wall, such that the needle penetration could be safe, even if targeted to a plane or volume of tissue that is at, or deep to (beyond) the adventitial layer of the aorta, a pulmonary vein or renal artery. It is also anticipated that the distal needle could be a cutting needle rather than a coring needle and that the injection egress ports could be small injection holes (pores) cut into the sides of the injector tubes or distal needle, proximal to the cutting needle tip.
  • the expandable injector tubes or guide tubes may be self-expanding made of a springy material, a memory metal such as NITINOL or they may be made of a metal or plastic and expandable by other mechanical means.
  • the expandable legs with distal injection needles could be mounted to the outside of an expandable balloon whose diameter is controllable by the pressure used to inflate the balloon.
  • the entire INAS is designed to include a fixed distal guide wire or be advanced over a guide wire in either an over-the-wire configuration where the guide wire lumen runs the entire length of the INAS or a rapid exchange configuration where the guide wire exits the catheter body at least 10 cm distal to the proximal end of the INAS and runs outside of the catheter shaft for its proximal section.
  • the fixed wire version is preferred as it would have the smallest distal diameter.
  • the INAS would also include a tubular, thin-walled sheath that constrains the self-expanding injection tubes with distal needles and/or guiding tubes prior to deployment, and for removal from the body.
  • the sheath also allows the distal end of the INAS to be inserted into the proximal end of a guiding catheter or introducer sheath.
  • the sheath also serves to protect the operator(s) from possible needle sticks and exposure to blood borne pathogens at the end of the procedure when the INAS is removed from the patient's body.
  • injection needles, guiding tubes and injection tubes could be formed from a radiopaque material such as tantalum or tungsten or coated, or marked with a radiopaque material such as gold or platinum so as to make them clearly visible using fluoroscopy.
  • one or more of the injector needles could be electrically connected to the proximal end of the INAS so as to also act as a diagnostic electrode(s) for evaluation of the electrical activity in the area of the vessel wall.
  • this device could utilize one, or more than one neuroablative substances to be injected simultaneously, or in a sequence of injections, in order to optimize permanent sympathetic nerve disruption in a segment of the renal artery (neurotmesis).
  • the anticipated neurotoxic agents that could be utilized includes but is not limited to ethanol, phenol, glycerol, local anesthetics in relatively high concentration (e.g., lidocaine, or other agents such as bupivicaine, tetracaine, benzocaine, etc.), anti-arrhythmic drugs that have neurotoxicity, botulinum toxin, guanethidine, heated fluids including heated saline, hypertonic saline, KCI or heated neuroablative substances such as those listed above.
  • the present invention also envisions use of anesthetic agents such as lydocaine which if injected first or in or together with an ablative solution can reduce or eliminate any pain associated with the denervation procedure.
  • anesthetic agents such as lydocaine which if injected first or in or together with an ablative solution can reduce or eliminate any pain associated with the denervation procedure.
  • the target vessel wall e.g., renal artery
  • imaging techniques such as multislice CT scan, MRI or intravascular ultrasound imaging to get an exact measurement of the thickness and anatomy of the target vessel wall (e.g., renal artery) such that one could know and set the exact and correct penetration depth for the injection of the ablative agent prior to the advancement of the injector needles or injector tubes.
  • IVUS prior to use of the INAS may be particularly useful in order to target the exact depth intended for injection. This exact depth can then be targeted using the adjustable depth of penetration feature in our preferred embodiment(s).
  • the selection of penetration depth can be accomplished using the proximal handles of the guide tube embodiment or by selection of an appropriate product code for the other designs that might have two to five versions each with a different penetration depth limit.
  • INAS For use in the treatment of hypertension or CHF, via renal sympathetic nerve ablation, the present preferred embodiment of this invention INAS would be used with the following steps:
  • injector tubes with needles on the outer surface of an expandable balloon on the INAS in order to deliver 2 or more needles into the vessel wall of a target vessel to inject ablative fluid.
  • circumferential fluid based ethanol or other ablative fluid, a combination of ablative fluids, or heated fluid
  • ring segment a “ring segment” of the renal artery
  • the ablative fluid would be injected into the space between the two balloons and allowed to dwell for a short period of time allowing the fluid, such as ethanol to penetrate through the arterial wall and reach the adventitial layer, thus disrupting and ablating the sympathetic nerves running in this space. After the dwell period the space could be flushed with saline and the balloons deflated.
  • a single balloon with a smaller diameter near the middle of the balloon could function in the same way, as the ethanol or other ablative fluid, or a combination of ablative fluids, or heated fluid is injected in the “saddle-like” space in the central part of the balloon that is not touching the arterial wall.
  • another embodiment may include a circumferential band of polymer, hydrogel or other carrier, on the central portion of an inflatable balloon with the carrier containing the neurotoxic agent(s), such as alcohol, phenol, glycerol, lidocaine, bupivacaine, tetracaine, benzocaine, guanethidine, botulinum toxin, etc.
  • the balloon would be inflated at relatively low pressure to oppose the intimal surface of the renal arterial wall, and inflated for a dwell time to allow penetration of the neurotoxic agent, circumferentially, into a “ring segment” of the renal artery and allow ablation of the sympathetic nerve fibers running near or in the adventitial plane.
  • the INAS catheter could be connected to a heated fluid, or steam, source to deliver high temperature fluids to ablate or injure the target tissue or nerves.
  • the heated fluid could be normal saline, hypertonic saline, alcohol, phenol, lidocaine, or some other combination of fluids.
  • Steam injection, of saline, hypertonic saline, ethanol, or distilled water or other fluids via the needles could also be performed in order to achieve thermal ablation of target tissue or nerves at and around the needle injection sites.
  • the INAS could utilize very small diameter needle injection tubes (e.g., 25-35 gauge) with sharpened needles at their distal ends such that the needles would be advanced to, or even through the adventitial plane of the renal artery or aortic wall using a penetration limiting member(s) or the combination of the guide tubes with an adjustable depth advancement of injector tubes through the guide tubes in order to set the depth of penetration, and allow one to “bathe” the adventitial layer containing the sympathetic nerves with neurotoxic fluid, while causing minimal injury to the intimal and medial vessel wall layers, These very tiny needles could pass transmurally through the arterial wall yet create such tiny holes in the arterial wall that blood leakage from the lumen to outside the vessel as well as medial layer injury would be minimal, and thus safe.
  • very tiny needle injection tubes e.g., 25-35 gauge
  • the present invention could have the injection be either into the wall of the renal artery, into the adventitia of the renal artery or deep to the adventitial layer of the renal artery such that the injection needles or egress from injection tubes would occur via penetration all the way through the arterial wall to allow the ablative fluid to flow around and “bathe” the outside of the artery with one or more neuroablative substances.
  • Another embodiment may include two or more pores, or small metallic (very short) needle like projections on the outer surface of the central portion of an inflatable balloon, that would be in fluid communication with an injection lumen to allow injection into the wall of the renal artery and allow circumferential delivery of a neurotoxic agent(s).
  • Another embodiment of the present invention places the means to limit penetration of the vessel wall at the proximal end of the INAS.
  • at least three guide tubes with expandable distal portions run along the distal portion of the length of the INAS.
  • a guide tube handle with optional flushing port is attached to the proximal end of the INAS and controls the longitudinal motion of the guide tubes.
  • One injection tube is included for each guide tube where the injection tubes have sharpened (cutting needle) distal ends with injection egress ports just proximal to the cutting needle tip.
  • the injection tubes are located coaxially inside of the guide tubes.
  • the distal ends of the sharpened injection needles at the distal ends of the injection tubes are initially “parked” just proximal to the distal end of the guide tubes.
  • a proximal injection tube handle attached to the proximal end of the injection tubes, or to the proximal end of a single injector tube that connects to the multiple injector tubes, is separated at its distal end from the proximal end of the guide tube handle forming a needle advancement gap.
  • the injector tube handle has means to adjust the needle advancement gap distance.
  • the adjustment could be on the guide tube handle or a separate mechanism between the injector tube handle and guide tube handle.
  • a fitting for injection of an ablative fluid is attached to the injector tube handle and is in fluid communication with the injection lumens of the injector tubes.
  • a sheath lies outside of the guide tubes constraining them.
  • the proximal end of the sheath is attached to a sheath handle which can be locked down to prevent longitudinal motion with respect to the guide tubes or unlocked to allow the sheath to be moved in the proximal or distal direction to open and close the INAS.
  • the process to use the INAS handles is to have each of the lumens in the INAS flushed with normal saline.
  • the distal end of the INAS is then advanced through a guiding catheter into a vessel such as a renal artery.
  • the sheath control handle is then pulled back holding the guide tube handle in position. This will allow the distal portion of the guide tubes to expand outwardly against the wall of a vessel such as a renal artery.
  • the guide tubes can then be pushed slightly forward using the guide tube handle to ensure they are engaged firmly against the vessel wall.
  • the injector tube handle is then advanced so as to push the distal ends of the injection tubes having sharpened injection needles out of the distal end of the guide tubes which are touching the inside of the vessel wall.
  • the needles will penetrate into the media of the vessel wall.
  • the penetration of the needles into the vessel wall can be limited. This can permit selective injection through the injection egress ports of the needles into the media, adventitia, outside of the adventitia or any combination of these depending on the number and location of injection egress ports.
  • a source of ablative fluid such as ethanol is attached to the fitting in the injection tube handle and the fluid is injected through the lumens inside the injector tubes and out through the injection egress ports into the tissue.
  • the injection tube handle is pulled back to retract the needles into the distal portion of the guide tubes.
  • the sheath control handle is then advanced to collapse the guide tubes and close the INAS.
  • the sheath control handle is then locked down to prevent inadvertent opening of the INAS.
  • the INAS is then pulled back onto the guiding catheter and the same procedure can be repeated for the other renal artery.
  • INAS is to have a percutaneously delivered catheter that can be used to treat atrial fibrillation with one, or more injections of an ablative fluid into the vessel walls of the pulmonary veins near the ostium, or into the left atrial tissue surrounding one or more of the pulmonary veins.
  • INAS is to have a percutaneously delivered catheter that can be used to treat hypertension with one, or more injections of an ablative fluid into or deep to, the vessel wall of the renal arteries, or into the wall of the aorta surrounding the ostium of the renal artery.
  • INAS is to facilitate injection of an ablative fluid into or beyond the outer layers of the renal artery to reduce or prevent injury to the inner layers including the media of the renal artery.
  • INAS has a percutaneously delivered catheter that includes a multiplicity of circumferentially expandable injector tubes, each tube having a needle at its distal end with injection egress allowing the delivery of an ablative fluid into the wall of a target vessel or into the space beyond the vessel wall.
  • Still another object of the invention is to have a flexible penetration limiting member or means attached just proximal to the distal end of each injector needle, or relatively blunt tipped guiding tubes to limit the depth of needle penetration into, or just through, the vessel wall.
  • Still another object of the present invention is to have a sheath that in conjunction with a distal tip provide for open and closed positions of the INAS.
  • the closed position has the sheath and distal tip touching so as to totally enclose the sharpened needles while the open position allows the needles to expand outward for injection of the ablative fluid into or deep to the vessel wall.
  • Yet another object of the present invention is to use heated or cooled ablative fluid to be the source of the tissue ablation such as with heated or cooled normal saline or enhance the efficacy of an already ablative fluid such as ethanol.
  • INAS is to have one or more of the injector needles act as diagnostic electrodes for measurement of electrical activity within the wall of the target vessel.
  • Yet another object of this invention is to use a multiplicity of coaxially guided injector tubes that move slidably within corresponding expandable guiding tubes, to allow the safe, controlled and adjustable depth of passage of injector tubes with sharpened needles at their distal ends into and/or through the wall of a target vessel, to allow controlled chemoablation of nerves in the adventitial layer of an artery while minimizing intimal and medial injury of said artery.
  • Yet another object of the present invention is to provide injection of an anesthetic agent before or during injection of the ablative fluid so as to prevent or reduce any pain associated with the denervation procedure.
  • FIG. 1 is a longitudinal cross section drawing of the distal portion of the present invention Vascular Nerve Ablation System (INAS) having a fixed guide wire at its distal end.
  • INAS Vascular Nerve Ablation System
  • FIG. 2 is a schematic view of the distal portion of the INAS in its closed position as it would be configured for delivery into the human body or to cover the injector needles during removal from the human body.
  • FIG. 3 is a schematic view of the distal portion of the INAS in its open position as it would be configured for delivery of an ablative solution into the target vessel wall.
  • FIG. 4 is a longitudinal cross sectional drawing of the proximal end of the fixed wire embodiment of the INAS of FIGS. 1 through 3 .
  • FIG. 5A is a schematic view of the distal portion of the closed INAS of FIG. 2 as it is first advanced out of a guiding catheter into a renal artery.
  • FIG. 5B is a schematic view of the distal portion of the closed INAS as the sheath is being pulled back to allow the expandable tubes open against the wall of the renal artery distal to the ostium.
  • FIG. 5C is a schematic view of the distal portion of the fully open INAS of FIG. 3 with needles fully embedded into the wall of the renal artery to allow the infusion of an ablative substance into the vessel wall.
  • FIG. 5D is a schematic view of the distal portion of the closed INAS as the distal portion of the INAS is being pulled back into the sheath to close the INAS either for subsequent use in the other renal artery or for removal from the body.
  • FIG. 5E is a schematic view of the distal portion of the closed INAS of FIG. 2 after it has been closed by retraction of the distal portion of the INAS into the sheath either for subsequent use in the other renal artery or for removal from the body.
  • FIG. 6 is a longitudinal cross section drawing of the embodiment of the INAS that is delivered over a separate guide wire.
  • FIG. 7 is a longitudinal cross sectional drawing of the proximal end of an over-the-wire embodiment of the INAS of FIG. 6 .
  • FIG. 8 is a longitudinal cross section drawing of an injector capable of delivering a heated ablative solution into the INAS of FIGS. 1-4 .
  • FIG. 9 is a longitudinal cross section drawing of the proximal section of an injection needle showing longitudinal welded wire penetration limiting members.
  • FIG. 10 is a longitudinal cross section drawing of the proximal section of another embodiment of the present invention that delivers an ablative fluid circumferentially to the inside of a target vessel.
  • FIG. 11 is a longitudinal cross section of another embodiment of the present invention INAS in its closed position having four injector tubes that can slide within four guide tubes.
  • the injector tubes have sharpened needles having injection egress ports at the distal end of each injector tubes.
  • FIG. 12 is an enlargement of the area S 12 of FIG. 11 showing the distal portion of the injector tubes and guide tubes.
  • FIG. 13 is a circumferential cross section at S 13 -S 13 of the INAS of FIG. 11
  • FIG. 14 is a longitudinal cross section of the expanded distal portion of the INAS.
  • FIG. 15 is an enlargement of the area S 15 of FIG. 14 .
  • FIG. 16 is a longitudinal cross section of the proximal end of the INAS of FIGS. 11-15 .
  • FIG. 17 is an enlargement of the area S 17 of FIG. 16 .
  • FIG. 18 is an enlargement of the area S 18 of FIG. 16 .
  • FIG. 19 is a longitudinal cross section of an alternate embodiment of all but the distal portion of the INAS using multiple guide tubes.
  • FIG. 20 is a longitudinal cross section of a central transition portion connecting the proximal portion of the of the INAS of FIG. 19 with the distal portion of the INAS of FIGS. 11 - 14 .
  • FIG. 21 is a circumferential cross section at S 21 -S 21 of the INAS central transition portion of FIG. 20 .
  • FIG. 22 is a circumferential cross section at S 22 -S 22 of the INAS central transition portion of FIG. 20 .
  • FIG. 23 is a circumferential cross section at S 23 -S 23 of the INAS central transition portion of FIG. 20 .
  • FIG. 1 is a longitudinal cross section drawing of the distal portion of the present invention Vascular Nerve Ablation System (INAS) 10 having a fixed guide wire 25 with tip 28 at its distal end.
  • FIG. 1 shows the INAS 10 in its fully open position with the self-expanding injector tubes 15 with distal ends sharpened to form injection needles 19 open to their maximum diameter.
  • Flexible cords 13 with adhesive 14 that attaches the cords 13 to the injector tubes 15 act as a penetration limiting member to prevent the distal tip of the needles 19 from penetrating more than a maximum distance L into a vessel wall.
  • the injector tubes can be made from any springy material with the preferred material being NITINOL.
  • a separate spring or inflatable balloon could be placed inside of the injector tubes if the tubes are self-expanding to achieve the same objective. A balloon while increasing the diameter of the system would be able to push the needles with great force into the vessel wall.
  • a sheath 12 with radiopaque marker 27 is shown in FIG. 1 in its position where it has been pulled back to allow full expansion of the injector tubes 15 .
  • the distance L can be between 0.2 and 2 mm with the optimal being about 1 mm.
  • the distal section 20 of the INAS 10 includes the distal wire 25 , tapered flexible tip 26 , radiopaque maker 24 and sheath engagement section 22 that assures that the distal portion of the INAS 10 will properly pull back into the sheath 12 following use of the INAS 10 to ablate tissue in a vessel of the human body.
  • the INAS 10 is fully closed when the two radiopaque markers 27 and 24 are next to each other. This provides a visual indication during fluoroscopy.
  • the proximal end of the injector tubes 15 are held by a manifold 17 that is attached inside the distal end of the outer tube 16 and the core wire 11 .
  • the proximal end of the outer tube 16 is attached to a hypotube 18 that continues to the proximal end of the INAS 10 .
  • the hypotube 18 is typically made from a metal like 316 Stainless steel and the outer tube 16 is made from a plastic or metal reinforced plastic so that it is flexible enough to allow the INAS to easily be advanced and retracted around the bend in a typical guiding catheter such as that used for angioplasty or stenting of the renal arteries.
  • the outer tube 16 would typically be between 5 and 30 cm long although it is also envisioned that the INAS 10 could be designed without a hypotube 18 and only a plastic or metal reinforced plastic outer tube 16 running to the proximal end.
  • the core wire 11 is attached to the inside of the hypotube 18 at junction point 23 . This attachment could for example be by adhesive means, welding or brazing. Spot welding is the preferred method. In this way, the core wire 11 that supports the fixed wire 25 cannot be easily detached form the INAS 10 .
  • the injector lumen 21 inside of the hypotube 18 connects to the lumen of the outer tube 16 which is in fluid communication with the injector tube lumens 29 of each of the expandable tubes 15 allowing an ablative substance or solution to flow from the proximal end of the INAS 10 through the hypotube 18 , through the outer tube 16 , through the expandable injector tubes 15 and out of the sharpened injector needles 19 into a vessel wall.
  • FIG. 2 is a schematic view of the distal portion of the INAS 10 ′ in its closed position as it would be configured for delivery into the human body or to cover the injection needles 19 during removal from the human body.
  • the INAS 10 ′ includes fixed wire 25 with tip 28 , core wire 11 , outer tube 16 and sheath 12 .
  • the two radiopaque markers 27 and 24 are adjacent to each other with the sheath 12 being advanced to it fully distal position.
  • the sharpened needles 19 are completely enclosed by the sheath 12 which is closed over the proximal portion of the tapered tip 26 .
  • FIG. 3 is a schematic view of the distal portion of the present invention Intravascular Nerve Ablation System (INAS) 10 in its fully open position having a fixed guide wire 25 with tip 28 at its distal end.
  • FIG. 3 shows the INAS 10 in its fully open position with the self-expanding injector tubes 15 with distal ends sharpened to form injection needles 19 open to their maximum diameter.
  • Flexible cords 13 with adhesive 14 that attaches the cords 13 to the injector tubes 15 act as a penetration limiting member to prevent the distal tip of the needles 19 from penetrating more than a maximum distance L shown in FIGS. 1 and 3 into a vessel wall.
  • a sheath 12 with radiopaque marker 27 is shown in FIG. 3 in its position where it has been pulled back to allow full expansion of the injector tubes 15 .
  • injector tubes 15 there are 4 injector tubes 15 in this embodiment of the INAS.
  • the distal section 20 of the INAS 10 includes the fixed distal wire 25 , tapered flexible tip 26 , radiopaque maker 24 and sheath engagement section 22 that assures that the distal portion will properly pull back into the sheath 12 following use of the INAS 10 to ablate tissue in a vessel of the human body.
  • Also shown in FIG. 3 are the outer tube 16 with injection lumen 21 and core wire 11 .
  • FIG. 4 is a longitudinal cross sectional drawing of the proximal end of the fixed wire embodiment of the INAS 10 of FIGS. 1 through 3 .
  • the hypotube 18 with injection lumen 21 also shown in FIG. 1 has a Luer fitting 35 with lumen 36 attached to its proximal end allowing a source of an ablative substance of solution to be injected through the lumen 36 of the Luer fitting 35 into the lumen 21 of the hypotube 18 and subsequently out of the injection needles 19 of FIG2s. 1 through 3 .
  • the proximal end of the sheath 12 is attached to the distal end of the Tuohy-Borst fitting 30 with handle, 36 , inner hub 33 washer 39 and O-Ring 43 .
  • a side tube 31 with Luer fitting 32 having a lumen 34 is designed to allow the lumen 38 between the inside of the sheath 12 and hypotube 18 to be flushed with saline before insertion of the INAS 10 into a human body.
  • the Tuohy-Borst fitting 30 is tightened onto the hypotube 18 with the sheath 12 in its most distal position and the INAS 10 ′ closed as is shown in FIG. 2 .
  • the Tuohy-Borst fitting When in the distal end of the INAS 10 ′ is properly positioned in one of the renal arteries, the Tuohy-Borst fitting is loosened and the handle 36 is pulled in the proximal direction while the Luer fitting 35 his held in place. This will open the INAS 10 and allow the injector tubes 15 of FIG. 1 to expand outward in the vessel.
  • FIG. 5A is a schematic view of the distal portion of the closed INAS 10 ′ of FIG. 2 as it is first advanced out of a guiding catheter 80 into a renal artery just distal to the ostium with the aorta.
  • the INAS 10 ′ is advanced until the marker band 24 distal to the distal end of the guiding catheter 80 . It is anticipated that an optimal distance of 5 to 15 mm distal would work best although shorter and longer distances are possible depending on the geometry of the renal artery and the distance of penetration of the guiding catheter 80 into the ostium of the renal artery.
  • FIG. 5B is a schematic view of the distal portion of the closed INAS 10 ′′ as the sheath 12 is being pulled back to allow the expandable tubes 15 open against the wall of the renal artery just distal to the ostium into the aorta.
  • the angle A at which the distal end of the injection needles engage the inside of the vessel wall should be less than 80 degrees and ideally between 40 and 60 degrees. If the angle is too large, the injection tubes could buckle backwards instead of pushing the sharpened needles into the vessel wall. If the angle is too small, the needles might not penetrate properly and might slide distally along the inside of the vessel wall.
  • the INAS 10 ′′ is then pushed in the distal direction allowing the injector tubes 15 to continue their outward expansion as the injection needles 19 penetrate into the wall of the renal artery. The penetration will stop when the cords 13 engage the wall of the renal artery limiting the penetration of the needles 19 .
  • this “cord” may be replaced by a nitinol wire structure that is fixably attached to the injector tubes 15 to provide a (stiffer) metallic penetration limiting member.
  • FIG. 5C is a schematic view of the distal portion of the fully open INAS 10 of FIG. 3 with needles 19 fully embedded into the wall of the renal artery to allow the infusion of an ablative substance into the vessel wall.
  • FIG. 5C show the cords 13 fully expanded, it would be typical for them to be slightly less in diameter than their maximum diameter when they engage the wall of the renal artery to limit the penetration of the needles 19 .
  • the maximum diameter of the INAS 10 system selected for the procedure should be at least 2 to 4 mm greater than the inside diameter of the renal artery. For example, if the renal artery diameter at the desired ablation site is 5 mm in diameter, then a INAS 10 with maximum diameter of 7 to 9 mm should be selected. In the configuration of FIG.
  • the ablative substance is injected through the needles 19 into the wall of the renal artery.
  • the preferred ablative substance is ethyl alcohol (ethanol), which has historically been used to ablate tissue, particularly nerve tissue in the cardiovascular system.
  • Other agents such as phenol, glycerol, local anesthetic agent(s) such as lidocaine, guenethidine or other cytotoxic and/or neurotoxic agents are also anticipated as possible injectates.
  • FIG. 5D is a schematic view of the distal portion of the closed INAS 10 ′′ as its distal portion is being pulled back into the sheath 12 to close the INAS 10 ′′ either for subsequent use in the other renal artery or for removal from the body.
  • a shaded area shows the ablated region 100 where the tissue in the wall of the renal artery has been ablated. If the needle depth of penetration is set at a greater depth (e.g. 2.5-3 mm) the ablation zone may be deeper (primarily adventitial) and create less injury to the intimal and medial layers of the renal artery wall than is shown in 5 D.
  • FIG. 5E is a schematic view of the distal portion of the closed INAS 10 ′ of FIG. 2 after it has been closed by retraction of the distal portion of the INAS into the sheath 12 either for subsequent use in the other renal artery or for removal from the body.
  • the method of use for hypertension would be the following steps:
  • a similar approach can be used with the INAS 10 , to treat atrial fibrillation through a guiding catheter inserted through the septum into the left atrium with the wall of the target vessel being the wall of one of the pulmonary veins.
  • FIG. 6 is a longitudinal cross section drawing of the distal portion of another embodiment the present invention Vascular Nerve Ablation System (INAS) 40 that is delivered over a separate guide wire 60 .
  • FIG. 6 shows the INAS 40 in its fully open position with the self-expanding injector tubes 45 with distal ends sharpened to form needles 49 open to their maximum diameter.
  • Flexible cords 43 connect the injector tube 45 and act as a penetration limiting member to prevent the distal tip of the needles 49 from penetrating more than a maximum distance D into a vessel wall.
  • the cords 43 are fed though holes 57 in the sides of each injector tube 45 a distance D from the distal end.
  • a drop of adhesive (not shown) can be used to seal the holes and prevent leakage of the ablative substance or solution during injection into a vessel wall.
  • a sheath 42 is shown in its position where it has been pulled back to allow full expansion of the injector tubes 45 .
  • the distance D can be between 0.2 and 2 mm with the optimal being about 0.5-1 mm.
  • the proximal end of the injector tubes 45 are held by a manifold 47 that is attached inside the distal end of the outer tube 46 and the inner tube 48 .
  • An injection lumen 51 lies between the inner tube 48 and outer tube 46 proximal to the manifold 47 . Ablative material injected through the injection lumen 51 will flow into the proximal ends of the injector tubes 45 and then out of the injection needles 49 into one or more layers of the blood vessel and/or into the volume of tissue just outside the vessel wall.
  • the distal section 50 of the INAS 40 that is coaxially attached to the distal section of the inner tube 48 includes the tapered flexible tip 56 , radiopaque maker 55 and sheath engagement section 54 that assures that the distal portion of the INAS 40 will properly pull back into the sheath 42 following use of the INAS 40 to ablate tissue in a vessel of the human body.
  • the guide wire 60 can be advance and retracted in the longitudinal direction inside of the guide wire lumen 41 that lies inside of the inner tube 48 .
  • the INAS 40 can be configured either as an over-the-wire or a rapid exchange device. If over-the-wire, the guide wire lumen 41 inside of the inner tube 48 runs all the way to the proximal end of the INAS 40 as is shown in FIG. 7 .
  • the guide wire would exit from the INAS 40 and run external to the outside of the INAS 40 for some portion of the length of the INAS 40 . If a rapid exchange is used then a slot will be needed in the sheath 42 to allow for the sheath 42 to move longitudinally with respect to the rest of the INAS 40 .
  • the proximal end of the rapid exchange configuration would be identical to that of the fixed wire INAS 10 of FIG. 4 .
  • the guide wire would typically run outside of the body of the INAS 40 for at least the most proximal 10 cm with the preferred embodiment having the guide wire exit through the side of the outer tube 46 and sheath 42 between 5 and 15 cm from the distal end of the INAS 40 .
  • FIG. 7 is a longitudinal cross sectional drawing of the proximal end 70 of an over-the-wire embodiment of the INAS 40 of FIG. 6 .
  • the inner tube 48 has a Luer fitting 78 attached to its proximal end.
  • the guide wire 60 can be advanced through the guide wire lumen 41 inside of the inner tube 48 .
  • the proximal end of the outer tube 46 is attached to the hub 79 that is sealed against the inner tube 48 , forming the injection lumen 51 between the inner tube 48 and outer tube 46 .
  • a side tube 74 with lumen 76 connects into the hub 79 with a Luer fitting 75 attached to the proximal end of the side tube 74 .
  • a syringe or other injection device can be attached to the Luer fitting 75 to inject an ablative substance or solution through the lumen 76 into the injection lumen 51 into the injector tube 45 of FIG. 6 and out of the ends of the injection needles 49 into a vessel wall.
  • the proximal end of the sheath 42 connects to the hub 77 that acts as a handle to slide the sheath 42 coaxially over the outer tube 46 to open and close the INAS 40 of FIG. 6 .
  • a side tube 72 with lumen 73 connects into the hub 77 .
  • a Luer fitting 71 it attached to the proximal end of the side tube 72 to allow the lumen 62 between the sheath 42 and the outer tube 46 to be flushed with saline solution before introduction of the INAS 40 in to the human body.
  • the hub 77 shown here is a plastic member, it is envisioned that a Tuohy-Borst fitting such as the Tuohy-Borst fitting 30 of FIG. 4 could be used here and could be advantageous as it would allow one to lock the sheath 42 in position onto the outer tube 46 during insertion and removal from the body so that the distal end of the sheath 42 would remain in its most distal position protecting the injection needles 49 and protecting health care workers from exposure to needle stick injury.
  • FIG. 8 is a longitudinal cross section of a disposable injector 90 for use in providing ablative fluid heated to a preset temperature for injection through the INAS 10 of FIGS. 1-5C to ablate tissue in a human body.
  • the injector 90 includes a syringe 104 with fluid storage volume 99 and female Luer fitting 93 that would typically attach to a standard stopcock (not shown) the stopcock being connected to the male Luer fitting 35 at the proximal end of the INAS 10 of FIGS. 1-4 . It is also envisioned that a stopcock could be provided with either the injector 90 or INAS 10 or integrated into either.
  • the syringe 104 is surrounded by the heating coil 94 which is contained within the case 95 filled with heat insulation 96 .
  • the power for the heating coil 94 comes from the battery 98 with positive terminal 91 and negative terminal 92 housed in the battery case 97 .
  • a moveable plunger 101 with handle 102 and distal sealing gasket 103 is used to inject the heated ablative fluid in the volume 99 through the Luer fitting 93 into the INAS 10 injector lumen 21 of FIG. 4 where it will then flow out through the injector needles 19 of FIGS. 1 and 3 into the tissue as shown in FIG. 5C .
  • the injector 90 may include closed loop electronics with either a display of the temperature or one or more LEDs that let the user know when the ablative fluid in the syringe 104 is at the desired temperature.
  • the injector 90 could be manufactured for a single preset temperature or be adjustable to more than one temperature.
  • FIG. 8 shows a manual injection plunger 101
  • a fluid pump or mechanical system to depress the plunger could be integrated into the injector 90 .
  • heated fluid to abate tissue may be either effective by having a normally benign substance like normal saline heated to the point where the heat causes the tissue ablation or the heat may act to improve the ablative ability of a fluid such as alcohol that is normally ablative at room or body temperature.
  • FIG. 9 is a longitudinal cross section drawing of the proximal section of an injection needle 110 with lumen 111 and distal end 119 , showing attached longitudinal memory metal wire penetration limiting members 114 and 116 with proximal portions 112 and 113 respectively.
  • proximal portions 112 and 113 are attached (glued, welded or brazed) to the outside 115 of the needle so that when the needles 110 are released from inside of the sheath 12 of FIGS. 1-4 the distal portion of the wires 114 and 116 will assume their memory state as shown in FIG. 9 forming a member that will limit penetration of the needle tip 119 to approximately a preset distance L 2 .
  • the distance L 2 can be set to ensure the ablative fluid injected through the needle lumen 111 will emerge in the appropriate volume of tissue. Selection of the appropriate volume can be set by different values of L 2 such that the injection can be set to be in the media of the artery, the adventitia of the artery or outside the adventitia of the artery. While FIG. 9 shows two wires 114 and 116 , one wire would also function to limit penetration or 3 or more wires could also be used. Ideally the wire(s) would be attached to the outside of the needle 115 on the sides circumferentially of the needle and not on the inside or outside where the wires 114 and 116 would increase the diameter of the closed INAS 10 of FIGS. 1-4 before the sheath 12 is pulled back to deploy the needles.
  • An important aspect of the present invention is the circumferential delivery of the ablative fluid with respect to the vessel wall.
  • Such delivery from one or more injection egress points must attack the nerve tissue circumferentially and at the correct depth to ensure efficacy, and ideally to minimize injury to the healthy and normal cellular structures of the intimal and medial layers.
  • the circumferential delivery can be handled as described above in three different ways.
  • FIG. 10 is a schematic view of yet another embodiment of the distal portion of the present invention Intravascular Nerve Ablation System (INAS) 200 in its fully open position having a fixed guide wire 225 with tip 228 at its distal end.
  • FIG. 10 shows the INAS 200 in its fully open position with the self-expanding injector tubes 215 with distal ends sharpened to form injection needles 219 open to their maximum diameter.
  • the injector tubes 215 each have a double bend or kink 214 having length L 4 in the circumferential direction.
  • the kinks 214 act as a penetration limiting member to prevent the distal tip of the needles 219 from penetrating more than a maximum distance L 3 into a vessel wall.
  • a sheath 212 with radiopaque marker 227 is shown in FIG. 10 in its position where it has been pulled back to allow full expansion of the injector tubes 215 .
  • the distal section 220 of the INAS 200 includes the fixed distal wire 225 , tapered flexible tip 226 , radiopaque maker 224 and sheath engagement section 222 that assures that the distal portion will properly pull back into the sheath 212 following use of the INAS 200 to ablate tissue in a vessel of the human body.
  • Also shown in FIG. 10 are the outer tube 216 with injection lumen 221 and core wire 211 .
  • the INAS 200 of FIG. 10 would be used in the same way as the INAS 10 of FIGS.
  • kinks double bends
  • the kinks 214 being integrated into the injector tubes 215 as compared with the penetration limiter of FIGS. 1-5E which are attached to the injector tubes.
  • Adding the kinks 214 should be a matter of setting a double bend into the shape of the memory metal (e.g. NITINOL) tubing used to form each of the injector tubes 215 that have sharpened ends that form the injection needles 219 .
  • the injector tubes themselves limit the penetration into the wall of a target vessel. Processes for shaping and heat treating NITINOL tubing to set the memory are well known.
  • the present invention has discussed use of the INAS for ablating tissue in the human body. It may also have merit for intravascular injection of any fluid or medication.
  • the ability to limit the depth of penetration allows it to inject any fluid selectively into the media, adventitia or outside of the adventitia of a blood vessel. It is also envisioned that the use of the double bend penetration limiting member concept of FIG. 10 could be applied to any application where fluid injection is required at a preset distance into human tissue.
  • circumferential delivery is defined here as at least three points of simultaneous injection spaced circumferentially within a vessel wall, or circumferential filling of the space outside of the adventitial layer (outer wall) of a blood vessel.
  • FIG. 11 is a longitudinal cross section of the another embodiment of the present invention INAS 300 in its closed position having four injector tubes 316 that can slide within four guide tubes 315 having expandable distal portions.
  • the injector tubes 316 with sharpened needles 319 have injection egress ports 317 near the distal end of each injector tube 316 .
  • a sheath 312 with distal radiopaque marker band 327 encloses the guide tubes 315 with coaxial injector tubes 316 .
  • the injector tubes 316 have injection lumens 321 .
  • the distal end of each of the guide tubes 329 are tapered to provide a surface that will be approximately parallel to the vessel wall when the guide tubes 315 expand outward during deployment.
  • the distal portion of the guide tubes 315 having a length L 5 are set in an expanded memory shape and as shown in FIG. 11 are constrained by the sheath 312 to prevent expansion.
  • the four guide tubes 315 are not attached or connected to the core wire 311 over the distance L 5 .
  • Proximal to the distance L 5 the guide tubes 315 are attached or connected to the core wire 311 with the preferred embodiment shown in FIG. 13 where the core wire 311 and four guide tubes 315 are embedded in a plastic cylinder 305 .
  • the INAS 300 distal end has a tapered section 326 attached to a distal shapeable fixed guide wire 320 with wire wrap exterior 325 , core wire 311 and tip 328 .
  • the tapered section 326 includes a radiopaque marker 324 and proximal taper 323 to facilitate closing the sheath 312 over the proximal section 323 following deployment of the INAS 300 to inject ablative fluid into a vessel wall.
  • FIG. 12 is an enlargement of the area S 12 of the INAS 300 of FIG. 11 showing guide tubes 315 located coaxially inside of the sheath 312 .
  • the distal portion of the injector tubes 316 having sharpened needles 319 , lumens 321 and injection egress ports 327 are located coaxially inside of the distal portion of the guide tubes 315 with tapered distal ends 329 .
  • All or a portion of the needles 319 or the entire injector tube(s) may be made of a radiopaque material such as tantalum, platinum or gold.
  • the ends of the needles may be coated or plated with a radiopaque material such as gold or that a platinum insert is placed into the distal tip of the injection tube prior to sharpening the tip into a cutting needle.
  • a radiopaque material such as gold
  • the core wire 311 and the proximal section 323 of the tapered section 326 are also shown.
  • a distal portion including the distal end 329 of the guide tubes 315 may also be made of, coated or plated with a radiopaque material such as gold.
  • FIG. 13 is a circumferential cross section at S 13 -S 13 of the INAS 300 of FIG. 11 clearly showing the four guide tubes 315 attached to the outside of the core wire 31 .
  • the injector tubes 316 with injection lumens 321 are located coaxially inside of the guide tubes 315 .
  • the injection tubes 316 are free to slide in the longitudinal direction within the lumens of the guide tubes 315 .
  • the injection tubes 316 could also be formed from nitinol and pre-shaped to parallel the curved distal shape of the guide tubes 315 to enhance the coaxial movement of the injector tubes 316 within the guide tubes 315 .
  • the guide tubes 315 , injection tubes 316 and core wire 311 lie coaxially within the sheath 312 which is free to slide over these parts.
  • the guide tubes 315 and core wire 311 are be embedded in plastic 305 to better hold the parts together or they could be joined by welding, brazing of use of an adhesive.
  • the use of the plastic 305 also allows a cylindrical surface to which the proximal portion of the sheath 312 can seal to allow flushing of the space between the inside of the sheath 312 and the outside of the plastic 305 with saline before the start of device use.
  • FIG. 14 is a longitudinal cross section of the expanded distal portion of the INAS 300 ′ in the fully open configuration with the injection tubes 316 shown advanced beyond the distal end of the guide tubes 315 .
  • the distal end of the injector tubes 316 has the sharpened needles 319 with injection egress ports 317 .
  • the guide tubes 315 are typically made from a memory metal such as NITINOL.
  • the injector tube 316 may be made from any metal such as 316 surgical grade stainless steel or may also be made from NITINOL or a radioopaque metal such as tantalum or platinum.
  • the elements 315 and 316 are not fabricated from a radio-opaque metal it is envisioned that distal portion of the injector tube(s) 316 and guide tube(s) 315 would be coated with a radio-opaque material such as gold, typically at or near the distal end of the tube(s) or a piece of radiopaque material may be used to form or be located near the sharpened needles 319 at the distal end of the injector tubes.
  • the diameter L 6 denotes the memory configuration for the fully open guide tubes 315 . For use in the renal arteries, L 6 would typically be between 3 and 10 mm with 8 mm being a best configuration if only one size is made as very few renal arteries are larger than 7 mm diameter. Also shown in FIG.
  • the distal ends 329 of the guide tubes 315 that in the fully open configuration are parallel to the longitudinal axis of the INAS 300 ′.
  • the distal portion of the INAS 300 ′ has the tapered section 326 attached to the fixed guide wire 320 with tip 328 , outer layer 325 and core wire 311 .
  • FIG. 15 is an enlargement of the area S 15 of FIG. 14 as it would appear with the distal end of the injector tube 316 with lumen 321 and distal needle 319 fully advanced beyond the distal end 329 of the guide tube 315 . Also shown in FIG. 15 is the arterial wall with internal elastic lamina (IEL), Media, External Elastic Lamina (EEL) and adventitia. FIG. 14 shows that the injection egress ports 317 are placed into the heart of the adventitia.
  • IEL internal elastic lamina
  • EEL External Elastic Lamina
  • INAS 300 An important feature of the present invention INAS 300 is that the penetration depth for injection through the injection egress ports is adjustable so that any of the following can be accomplished.
  • the distance L 7 that the tip of the needle 319 extends beyond the end 329 of the guide tube 315 can be adjusted using the apparatus in the proximal end of the INAS 300
  • FIG. 16 is a longitudinal cross section of the proximal end of the INAS 300 of FIGS. 11-15 .
  • Three handles, the proximal injection handle 330 , the central guide tube handle 340 and the distal sheath control handle 350 allow the relative longitudinal movement of the sheath 312 , guide tubes 315 and injector tubes 316 .
  • the position shown for FIG. 16 has the sheath control handle 350 in its most proximal position which would indicate the sheath 312 has been fully pulled back in the proximal direction which would allow the guide tubes 315 to expand outward as shown in FIG. 14 .
  • the gap with distance L 8 between the injection handle 330 and the guide tube handle 340 can be adjusted using the screw adjustment piece 334 with screw threads 335 that allow it to move with respect to the proximal portion 333 of the injection handle 330 .
  • the gap L 8 as set will limit the penetration of the needles 319 and injection egress ports 317 of the injector tubes 316 into the wall of the target vessel.
  • a scale can be marked on the proximal portion 333 of the proximal injection handle 330 so that the medical practitioner can set the gap L 8 and thus adjust the penetration distance.
  • a luer fitting 338 with access tube 336 is the port for ablative fluid injection into the handle central lumen 332 which is in fluid communication with the lumens 321 of the injector tubes 316 .
  • the central guide tube handle 340 includes an outer portion 342 , a sealing member 344 that seals the distal portion of the core wire 311 to the outer portion 342 and provides four holes through which the four injector tubes 316 can slide into the proximal ends of the guide tubes 315 .
  • a Luer fitting 348 with access tube 346 provides access to the space between the injector tubes 316 and the guide tubes 315 through holes in the guide tubes 347 .
  • the distal sheath control handle 350 includes a distal portion 354 attached to the outside of the sheath 312 with Luer fitting 358 and side tube 356 providing access to the lumen under the sheath 312 to allow it to be flushed with saline before the procedure begins.
  • the handle 350 also has proximal portion 352 and elastic washer 359 that is compressed by screwing the proximal portion 352 into the distal portion 354 to lock the position of the sheath 312 with respect to the guide tubes 315 .
  • FIG. 17 is an enlargement of the area S 17 of FIG. 16 showing the injection handle 330 with proximal Luer fitting 338 attached to the side tube 336 with lumen 331 .
  • the proximal portion 333 is sealed against the outside of the side tube 336 and also seals against the outside of the four injector tubes 316 . This sealing can be by an adhesive or by molding or forming the proximal piece onto the tubes 336 and 316 .
  • the lumen 331 of the side tube 336 is in fluid communication with the central lumen 332 of the proximal portion 333 which is in fluid communication with the lumens 321 of the injector tubes 316 .
  • an ablative fluid injected through the Luer 338 will flow into the lumens 321 of the injector tubes 316 and will emerge through the injection egress ports 317 shown in FIG. 15 into the tissue in or near the wall of the target vessel.
  • the screw threads 335 on both the proximal portion 333 and screw adjustment piece 334 of the injection handle 330 allow adjustment of the gap L 8 of FIG. 16 .
  • the gap L 8 as set will limit the penetration of the needles 319 and injection egress ports 317 of the injector tubes 316 into the wall of the target vessel.
  • a scale can be marked on the proximal portion 333 of the injection handle 330 so that the medical practitioner can set the gap L 8 and thus adjust the penetration distance.
  • FIG. 18 is an enlargement of the area S 18 of FIG. 16 showing the central guide tube handle 340 and the sheath control handle 350 .
  • the central guide tube handle 340 includes an outer portion 342 , a sealing member 344 that attaches the distal portion of the guide tubes 315 and core wire 311 to the outer portion 342 .
  • the outer portion 342 seals against the plastic 305 in which the guide tubes 315 and core wire 311 are embedded.
  • a Luer fitting 348 shown in FIG. 15
  • access tube 346 provides access to the space between the injector tubes 316 and the guide tubes 315 through holes 347 in the guide tubes 315 .
  • the distal sheath control handle 350 includes a distal portion 354 attached to the outside of the sheath 312 with Luer fitting 358 (shown in FIG. 15 ) and side tube 356 providing access to the lumen between the sheath 312 and the plastic 305 to allow it to be flushed with saline before the procedure begins.
  • the handle 350 also has proximal portion 352 and elastic washer 359 that is compressed by screwing the proximal portion 352 into the distal portion 354 to lock the position of the sheath 312 onto the plastic 305 . In this locked position with the INAS 300 closed as shown in FIG. 11 the INAS 300 is advanced into the body until the distal end with the marker band 324 of FIG. 11 is in the renal artery.
  • the proximal portion 352 is then loosened so that the sheath control handle 350 can be pulled in the distal direction while holding the central guide tube handle 340 fixed. It is envisioned that when the proximal end of the sheath control handle proximal piece 352 touches the distal end of the outer portion 342 of the guide tube handle 340 as shown in FIG. 18 , that the sheath 312 will be full retracted to allow expansion of the guide tubes 315 against the wall of the target vessel.
  • the full procedure for renal denervation using the INAS 300 is as follows:
  • a similar approach can be used with the INAS 300 , to treat atrial fibrillation through a guiding catheter inserted through the septum into the left atrium with the wall of the target vessel being the wall of one of the pulmonary veins.
  • FIG. 19 is a longitudinal cross section of the proximal portion of an alternate embodiment of the INAS 400 which simplifies the design as compared to the INAS 300 proximal portion of FIG. 16 .
  • the INAS 400 uses the identical distal portion design as the INAS 300 of FIGS. 11-15 .
  • Three handles, the proximal injection handle 430 , the central guide tube handle 440 and the distal sheath control handle 450 allow the relative longitudinal movement of the sheath 312 , middle tube 415 and inner tube 416 with injection lumen 421 .
  • the position shown for FIG. 19 has the sheath control handle 450 near its most proximal position which would indicate the sheath 312 has been pulled back in the proximal direction. In this position, as with the INAS 300 of FIGS. 11-18 this will cause the distal portion of the guide tubes 315 to expand outward as shown in FIG. 14 .
  • the gap with distance L 9 between the injection handle 430 and the guide tube handle 440 can be adjusted using the screw adjustment piece 434 with screw threads 435 that allow it to move with respect to the proximal portion 433 of the proximal injection handle 430 .
  • the proximal end of the screw adjustment piece 434 is the penetration limiting member that will limit to the distance L 9 , the penetration of the needles 319 and injection egress ports 317 of the injector tubes 316 into the wall of the target vessel.
  • a scale can be marked on the proximal portion 433 of the handle 430 so that the medical practitioner can set the gap L 9 and thus adjust the penetration distance.
  • the central tube 416 with lumen 421 is sealed into the proximal piece 433 of the proximal injection handle 430 .
  • a luer fitting 438 with access tube 436 is the port for ablative fluid injection into the handle lumen 432 .
  • the lumen 439 of the Luer fitting 438 is in fluid communication with the lumen 437 of the access tube 436 which is in fluid communication with the injection lumen 421 of the inner tube 416 .
  • the inner tube 416 is typically a metal hypertube although a plastic tube or plastic tube with braided or helical wire reinforcement is also conceived.
  • the central guide tube handle 440 attached to and controlling the longitudinal movement of the middle tube 415 includes a proximal portion 444 that can screw into a distal portion 442 .
  • the proximal portion 444 will compress the washer 445 allowing the handle 440 to be locked down onto the middle tube 415 . This is also needed during preparation for use when the Luer fitting 448 with side tube 446 can be used to flush the space between the inner tube 416 and middle tube 415 with saline solution.
  • the distal sheath control handle 450 attached to and controlling the longitudinal movement of the sheath 312 includes a proximal portion 454 that can screw into a distal portion 452 .
  • the proximal portion 454 will compress the washer 455 allowing the handle 450 to be locked down onto the sheath 312 .
  • This is also needed during preparation for use when the Luer fitting 458 with side tube 456 can be used to flush the space between the middle tube 415 and sheath 312 with saline solution.
  • FIG. 20 is a longitudinal cross section of a central transition portion 460 connecting the proximal portion of the INAS 400 of HG. 19 with the distal portion of the INAS 300 of FIGS. 11-15 .
  • the proximal end of the central transition portion 460 includes the same three concentric tubes located at the distal end of the handle portion of the INAS 400 shown in FIG. 19 .
  • the proximal end of the transition portion 460 includes the inner tube 416 with injection lumen 421 , the middle tube 415 and the sheath 312 .
  • a manifold 410 is inserted which seals the inner tube 416 to the four injector tubes 316 such that the lumen 421 of the inner tube 416 is in fluid communication with the lumens 321 of the four injector tubes 316 .
  • longitudinal motion of the inner tube 416 will therefore be translated to longitudinal motion of the four injector tubes 316 .
  • the middle tube 415 seals inside of the plastic member 405 which also seals to the guide tubes 315 and core wire 311 . Longitudinal motion of the middle tube 415 will translate into longitudinal motion of the four guide tubes 315 .
  • the sheath 312 is the same sheath as in the distal portions of the INAS 300 of FIGS. 11-15 .
  • FIG. 21 is a circumferential cross section at S 21 -S 21 of the central transition section 460 of FIG. 20 . Looking in the distal direction, one sees in cross section, the three concentric tubes the sheath 312 , middle tube 415 and inner tube 416 . Inside the inner tube one sees the proximal end of the manifold 410 and the proximal ends of the four injector tubes 316 . It can clearly be seen that the manifold 410 seals the four injector tubes 316 into the inner tube 416 and the lumens 321 of the injector tubes 316 open into the lumen 421 of the inner tube 416 .
  • FIG. 22 is a circumferential cross section at S 22 -S 22 of the central transition section 460 of FIG. 20 . Looking in the distal direction one sees in cross section, the sheath 312 and middle tube 415 . The middle tube 415 is sealed into the distal portion of the plastic member 405 . One also sees the proximal end of the four guide tubes 315 and core wire 411 . It also shows how the four injector tubes 316 enter the proximal ends of the guide tubes 315 .
  • FIG. 23 is a circumferential cross section at S 23 -S 23 of the central transition section 460 of FIG. 20 .
  • This cross section is identical to the circumferential cross section shown in FIG. 13 showing the sheath 312 and plastic member 405 (was 305 in FIG. 13 ) that seals and attaches together the four guide tubes 315 and the core wire 311 .
  • the injector tubes 316 lie concentrically inside of the four guide tubes 315 .
  • FIGS. 20-23 clearly show how the simplified proximal end of FIG. 19 connects to the distal portion of the INAS 300 of FIGS. 11-15 .
  • FIGS. 1-23 can be applied to the use of this apparatus 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.

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US13/294,439 2011-08-24 2011-11-11 Expandable catheter system for vessel wall injection and muscle and nerve fiber ablation Abandoned US20130053792A1 (en)

Priority Applications (21)

Application Number Priority Date Filing Date Title
US13/294,439 US20130053792A1 (en) 2011-08-24 2011-11-11 Expandable catheter system for vessel wall injection and muscle and nerve fiber ablation
US13/342,521 US9056185B2 (en) 2011-08-24 2012-01-03 Expandable catheter system for fluid injection into and deep to the wall of a blood vessel
EP12826228.4A EP2747688B1 (en) 2011-08-24 2012-08-22 Catheter system for vessel wall injection and perivascular renal denervation
US13/643,065 US10576246B2 (en) 2011-08-24 2012-08-22 Intravascular fluid catheter with minimal internal fluid volume
JP2014527272A JP6266516B2 (ja) 2011-08-24 2012-08-22 血管壁注入および血管周囲腎臓除神経のためのカテーテルシステム
PCT/US2012/051906 WO2013028781A1 (en) 2011-08-24 2012-08-22 Catheter system for vessel wall injection and perivascular renal denervation
CN201711417679.4A CN107899126B (zh) 2011-08-24 2012-08-22 用于血管壁注射和血管周肾去神经支配的导管系统
CN201280051666.9A CN103974670B (zh) 2011-08-24 2012-08-22 用于血管壁注射和血管周肾去神经支配的导管系统
SG11201400138YA SG11201400138YA (en) 2011-08-24 2012-08-22 Catheter system for vessel wall injection and perivascular renal denervation
HK15101344.4A HK1202399B (en) 2011-08-24 2012-08-22 Catheter system for vessel wall injection and perivascular renal denervation
US13/835,221 US20130274673A1 (en) 2011-08-24 2013-03-15 Intravascular ablation catheter with enhanced fluoroscopic visibility
US13/835,556 US20130274674A1 (en) 2011-08-24 2013-03-15 Intravascular ablation catheter with precision depth of penetration calibration
US14/738,776 US10118004B2 (en) 2011-08-24 2015-06-12 Expandable catheter system for fluid injection into and deep to the wall of a blood vessel
JP2017149730A JP6932037B2 (ja) 2011-08-24 2017-08-02 血管壁注入および血管周囲腎臓除神経のためのカテーテルシステム
US15/917,532 US10485951B2 (en) 2011-08-24 2018-03-09 Catheter systems and packaged kits for dual layer guide tubes
US16/178,940 US11007329B2 (en) 2011-08-24 2018-11-02 Expandable catheter system for fluid injection into and deep to the wall of a blood vessel
JP2019204891A JP7482616B2 (ja) 2011-08-24 2019-11-12 血管壁注入および血管周囲腎臓除神経のためのカテーテルシステム
US16/689,604 US11752303B2 (en) 2011-08-24 2019-11-20 Catheter systems and packaged kits for dual layer guide tubes
US16/805,033 US11759608B2 (en) 2011-08-24 2020-02-28 Intravascular fluid catheter with minimal internal fluid volume
US17/232,695 US20210290860A1 (en) 2011-08-24 2021-04-16 Expandable catheter system for fluid injection into and deep to the wall of a blood vessel
US18/449,528 US20240033479A1 (en) 2011-08-24 2023-08-14 Intravascular fluid catheter with minimal internal fluid volume

Applications Claiming Priority (2)

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US13/216,495 US9278196B2 (en) 2011-08-24 2011-08-24 Expandable catheter system for vessel wall injection and muscle and nerve fiber ablation
US13/294,439 US20130053792A1 (en) 2011-08-24 2011-11-11 Expandable catheter system for vessel wall injection and muscle and nerve fiber ablation

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US13/216,495 Continuation-In-Part US9278196B2 (en) 2011-08-24 2011-08-24 Expandable catheter system for vessel wall injection and muscle and nerve fiber ablation
US13/342,521 Continuation-In-Part US9056185B2 (en) 2011-08-24 2012-01-03 Expandable catheter system for fluid injection into and deep to the wall of a blood vessel
US13/643,065 Continuation-In-Part US10576246B2 (en) 2011-08-24 2012-08-22 Intravascular fluid catheter with minimal internal fluid volume
PCT/US2012/051906 Continuation-In-Part WO2013028781A1 (en) 2011-08-24 2012-08-22 Catheter system for vessel wall injection and perivascular renal denervation

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US20130053792A1 true US20130053792A1 (en) 2013-02-28

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US13/294,439 Abandoned US20130053792A1 (en) 2011-08-24 2011-11-11 Expandable catheter system for vessel wall injection and muscle and nerve fiber ablation
US13/643,065 Active 2035-12-13 US10576246B2 (en) 2011-08-24 2012-08-22 Intravascular fluid catheter with minimal internal fluid volume
US15/917,532 Active US10485951B2 (en) 2011-08-24 2018-03-09 Catheter systems and packaged kits for dual layer guide tubes
US16/689,604 Active 2033-04-27 US11752303B2 (en) 2011-08-24 2019-11-20 Catheter systems and packaged kits for dual layer guide tubes
US16/805,033 Active 2033-06-18 US11759608B2 (en) 2011-08-24 2020-02-28 Intravascular fluid catheter with minimal internal fluid volume
US18/449,528 Pending US20240033479A1 (en) 2011-08-24 2023-08-14 Intravascular fluid catheter with minimal internal fluid volume

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US13/643,065 Active 2035-12-13 US10576246B2 (en) 2011-08-24 2012-08-22 Intravascular fluid catheter with minimal internal fluid volume
US15/917,532 Active US10485951B2 (en) 2011-08-24 2018-03-09 Catheter systems and packaged kits for dual layer guide tubes
US16/689,604 Active 2033-04-27 US11752303B2 (en) 2011-08-24 2019-11-20 Catheter systems and packaged kits for dual layer guide tubes
US16/805,033 Active 2033-06-18 US11759608B2 (en) 2011-08-24 2020-02-28 Intravascular fluid catheter with minimal internal fluid volume
US18/449,528 Pending US20240033479A1 (en) 2011-08-24 2023-08-14 Intravascular fluid catheter with minimal internal fluid volume

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US (6) US20130053792A1 (enrdf_load_stackoverflow)
EP (1) EP2747688B1 (enrdf_load_stackoverflow)
JP (3) JP6266516B2 (enrdf_load_stackoverflow)
CN (2) CN103974670B (enrdf_load_stackoverflow)
SG (1) SG11201400138YA (enrdf_load_stackoverflow)
WO (1) WO2013028781A1 (enrdf_load_stackoverflow)

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Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:FISCHELL, DAVID R.;FISCHELL, TIM A.;REEL/FRAME:027282/0195

Effective date: 20111110

STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION