CN105578982A - Intravascular neuromodulation device having a spiral track and associated methods - Google Patents

Intravascular neuromodulation device having a spiral track and associated methods Download PDF

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Publication number
CN105578982A
CN105578982A CN201480053726.XA CN201480053726A CN105578982A CN 105578982 A CN105578982 A CN 105578982A CN 201480053726 A CN201480053726 A CN 201480053726A CN 105578982 A CN105578982 A CN 105578982A
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orbit
neuroregulation
orbit element
configuration
energy
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B·奥康奈尔
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Medtronic Ardian LLC
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Medtronic Ardian Luxembourg SARL
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0507Electrodes for the digestive system
    • A61N1/0514Electrodes for the urinary tract
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1492Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053Mechanical features of the instrument of device
    • A61B2018/00214Expandable means emitting energy, e.g. by elements carried thereon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345Vascular system
    • A61B2018/00404Blood vessels other than those in or around the heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00434Neural system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00505Urinary tract
    • A61B2018/00511Kidney
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1405Electrodes having a specific shape
    • A61B2018/1435Spiral

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  • Engineering & Computer Science (AREA)
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Abstract

Assemblies, systems, and methods for intravascular neuromodulation include a method of positioning a treatment device and a track element at a treatment site in an artery of a human patient and transforming the track element from a delivery configuration to a deployed configuration to form a spiral-shaped track tending to be in apposition with an inner wall of the artery. The treatment device has a distally-located neuromodulation element for sliding along the spiral-shaped track. The method can also include delivering energy via the neuromodulation element across the inner wall of a renal artery to heat or otherwise electrically modulate neural fibers that contribute to renal function.

Description

There is Ink vessel transfusing neuroregulation device and the correlation technique of helical orbit
Technical field
The technology of the present invention relates generally to Ink vessel transfusing neuroregulation and correlation technique.Specifically, some embodiments be for can along helical orbit location the device for intravascular renal neuroregulation and correlation technique.
Background
Sympathetic nervous system (SNS) is typically relevant to stress main non-autonomous health control system.Organizing in the nearly all tract of human body is all arranged by SNS fiber, and these SNS fibers can affect following characteristics such as pupil diameter, bowel movement and urine volume.Such adjustment in holder inner equilibrium or can make to have adaptability effectiveness in the quick response environment factor of health.But the chronic activation of SNS is the common unconformable reaction impelling numerous disease status progression.Especially, the excessive activation of kidney SNS has been accredited as that the complexity of hypertension, volume overload state (as heart failure) and progressive renal disease is physiopathologic may facilitate factor in experiment and human body.Such as, radioactive indicator dilution method has proved that overflowing speed at the patient's middle kidney norepinephrine (" NE ") suffering from essential hypertension increases.
In the patient suffering from heart failure, heart renal sympathetic nerve discharge excessively may be especially remarkable.Such as, often find to overflow from heart and kidney to the extraordinary NE of blood plasma in these patients.The SNS raised activates and is usually expressed as chronic and end stagerenaldisease.Verified, in the patient suffering from end stagerenaldisease, the NE blood plasma level higher than intermediate value is the indication of cardiovascular disease and some causes of death.This is also like this to the patient of trouble diabetes or radiographic contrast nephropathy.Evidence shows, the sensation input signal coming from the kidney of pathological changes be initial sum maintain that the central sympathetic that raises flows out mainly facilitate factor.
The sympathetic nerve of domination kidney ends in blood vessel, juxtaglomerular apparatus and renal tubules.The stimulation of renal sympathetic nerve can cause renin release increase, sodium (Na+) heavily absorbs increase and renal hemodynamic reduces.These neuroregulation components of renal function are subject to sizable stimulation in the morbid state being characterized as sympatheticotonia rising, and the blood pressure that may facilitate hyperpietic raises.As the result that kidney Sympathetic Nerve stimulates, the reduction of renal hemodynamic and glomerular filtration rate may be the basis of Cardiorenal syndrome (that is, as the renal dysfunction of the progressivity complication of chronic heart failure) middle kidney afunction.The pharmacology strategy stoping kidney to spread out of sympathetic stimulation consequence comprises the sympatholytic of central action, beta-blocker (being intended to reduce renin release), angiotensin converting enzyme inhibitor and receptor blocking agent (be intended to the Angiotensin II effect after blocking renin release and aldosterone activates) and diuretic (being intended to offset the water-sodium retention of the sympathetic mediation of kidney).But these pharmacology strategies have remarkable limitation, comprise limited efficacy, compliance problem, side effect and other.Recently, show, the endovascular device reducing sympathetic activity (such as, via radio-frequency (RF) ablation) by applying energy field to the target site in Renal vascular reduces the blood pressure of the patient suffering from refractory hypertension.
Brief Description Of Drawings
With reference to the following drawings, many aspects of this disclosure can be understood better.Parts in these accompanying drawings are necessarily not pro rata.On the contrary, focus in clear principle of showing this disclosure.In addition, clear in order to show, parts can be shown as transparent in some view, but not show that shown parts are necessarily transparent.For ease of reference, run through this disclosure, identical reference number can be used to identify identical or similar or similar at least generally parts or feature.
Fig. 1 is the partial schematic diagram of the neural modulation system configured according to the embodiment of the technology of the present invention.
Fig. 2 is being in sending state (such as, low section (low-profile) or shrink (collapsed) configuration) and being carried at the longitudinal cross-section view of the endovascular treatment assembly in delivery elements according to the embodiment of the technology of the present invention.
Fig. 3 A is the perspective view with the endovascular treatment assembly of Fig. 2 of spiral path being in deployable state (such as, launching configuration) in patient's renal artery of another embodiment according to the technology of the present invention.
Fig. 3 B is the viewgraph of cross-section of the endovascular treatment assembly intercepted along the line 3B-3B of Fig. 3 A.
Fig. 4 A is the viewgraph of cross-section of the endovascular treatment assembly configured according to the embodiment of the technology of the present invention.
Fig. 4 B is the viewgraph of cross-section of the endovascular treatment assembly configured according to another embodiment of the technology of the present invention.
Fig. 5 schematically illustrates and regulates kidney neural with the endovascular treatment assembly configured according to the embodiment of the technology of the present invention.
Fig. 6 A is in the endovascular treatment assembly of sending state (such as, low section or collapsed configuration) and the longitudinal cross-section view of seal wire according to another embodiment of the technology of the present invention.
Fig. 6 B is the perspective view of the endovascular treatment assembly of Fig. 6 A in patient's renal artery of another embodiment according to the technology of the present invention, and wherein seal wire is partly recalled and shown this curative component with deployable state (such as, launching configuration).
Fig. 7 is the flow chart of the method for endovascular treatment assembly for sending and dispose the embodiment according to the technology of the present invention.
Fig. 8 is the flow chart of the another kind of method of endovascular treatment assembly for sending and dispose the embodiment according to the technology of the present invention.
Describe in detail
The technology of the present invention is equipment and method for being realized electricity and/or thermoinducible kidney neuroregulation (that is, make nerve fiber passivation or the inactivation of domination kidney, or otherwise completely or partially reduce function) by percutaneous endoluminal vascular inner gateway.Specifically, the embodiment of the technology of the present invention relates to the curative component of the therapy equipment (such as, treating conduit) having orbit element and engage these orbit elements slidably.These curative components comprise at least one the neuroregulation element (such as, at least one electrode) of the distal portion office that can be positioned in such as this therapy equipment.After in the target blood being deployed in human patients, the distal portions of this orbit element can send or low profile status (such as, (straightened) shape of roughly aligning) to deployable state (such as, radial development, the shape of roughly spiral type/spiral) between conversion, this orbit element is defined and the juxtaposed spiral path of target blood (such as, renal artery) inwall.
This therapy equipment can comprise treatment conduit or another slender member, this slender member engages this orbit element slidably, makes the different treatment positions that this therapy equipment makes described neuroregulation element (one or more) described neuroregulation element (one or more) be positioned in target blood along this orbit element translation relative to the movement of this orbit element.In one embodiment, such as, this orbit element can be accommodated in this therapy equipment (such as, treatment conduit, microtubular, tubular sheath, etc.) inner chamber within and the extensible preformed spiral-shaped line (wire) (such as, nitinol wire) had in its distal portion office.Therefore, therapy equipment along dispose with static orbit element proximally or the movement of far-end can make this neuroregulation elements relative in target blood the longitudinal axis angularly or circumference and be longitudinally shifted.
The energy or the power generator of described neuroregulation element (one or more) and patient outside are in electrical communication, energy is delivered in arteriorenal multiple part along percutaneous intracavity path (such as, femoral artery puncture, iliac artery and aorta, radial artery or the another kind of Ink vessel transfusing path be applicable to) via the described neuroregulation element (one or more) after marching to renal artery.The energy pattern be applicable to comprises, such as, and electric energy, radio frequency (RF) energy, pulse electric energy or heat energy.The therapy equipment of carrying described neuroregulation element (one or more) can be designed size, shaping and have suitable flexibility, make described neuroregulation element (one or more) and renal artery inwall juxtaposition consistently when this orbit element is in deployments (such as, spiral type/spiral) state.The shape of carrying the preformed spiral type/spiral of the orbit element deployment part of this therapy equipment allows blood to flow through this assembly over the course for the treatment of, and expection contributes in the activation process of neuroregulation element (one or more), prevent arteriorenal obturation.
The manufacture comprising the energy delivery catheter system for inducing neural adjustment of electrod-array in the past may be expensive.Such as, multiple electrode requires that each electrode separates complicated algorithm and the design of wiring and power generator.In addition, when using conventional energy delivery catheter system, reorientating on renal artery inwall is challenging and consuming time with special damage (lesion) layout.On the contrary, the spiral type framework that slender member (such as, sheath, treatment conduit, microtubular, the etc.) oneself that can advance thereon launches provides the simple designs being easy to dispose and use compared to conventional manifold device.And in certain embodiments, described neuroregulation element can comprise single electrode, this electrode can along this orbit element proximally or far-end move, this orbit element remains on original position simultaneously.This moves can via to draw or pushing mechanism realizes, and this mechanism makes neuroregulation element slide along this spiral path, thus easily selected and melt or treatment position close to new.In addition, come close to multiple treatment position (each other circumference and be longitudinally shifted) due to neuroregulation element can be realized along the movement of orbit element, single neuroregulation element portion can be affixed one's name on a treatment apparatus.This design aspect avoids the separately wiring of multiple electrodes that may need, expection reduces and extra spaced electrode and connect up relevant manufacturing time and material cost, also reduces the complexity generally for the more than one absolute electrode of operation or the necessary control algolithm of energy delivery elements.
The detail of some embodiments of this technology is described in hereafter with reference to figure 1-7.Although following describes the multiple embodiments about device, system and the method using the Ink vessel transfusing for kidney nerve of spiral path element to regulate, other application except described herein and other embodiments are also within the scope of this technology.In addition, other embodiments some of this technology can have difference configuration except described herein, parts or program.Therefore, those of ordinary skill in the art will correspondingly understand, and this technology can have other embodiments with additional element, or this technology can have without the need to reference to shown in figure 1-7 and other embodiments of described some features.
As used herein, term " far-end " and " near-end " define position relative to the clinicist of responsible treatment or the control device (such as, Handleset) of clinicist or direction." far-end " or " distally " be away from clinicist or clinicist control device or be in the position leaving its direction." near-end " or " proximally " is close to clinicist or the control device of clinicist or the position towards its direction.
selected neural modulation system example
Fig. 1 is the partial schematic diagram of the kidney neural modulation system 10 (" system 10 ") configured according to the embodiment of the technology of the present invention.System 10 comprises the catheter in blood vessel 12 being operationally attached to the energy or power generator 30 (such as, RF power generator).Conduit 12 can comprise the slender axles 14 with proximal part 16 and distal portions 20.Conduit 12 is also included in the handle 18 at proximal part 16 place.Conduit 12 can comprise curative component or the treatment section 100 (schematically showing) at distal portions 20 (such as, be attached to distal portions 20, limit the section of distal portions 20, etc.) further.As hereafter explaining in further detail, curative component 100 can comprise the therapy equipment 120 of the distal portions of engagement rail element 110 slidably.Shown in Fig. 1 in exemplary overall crossover (over-the-wire, " OTW ") embodiment, the near-end of orbit element 110 extends from the port one 5 that exits handle 18.Therapy equipment 120 can be have one or more neuroregulation element or the energy delivery elements 122 being arranged in its far-end slender member (such as, sheath, treatment conduit, etc.).In one embodiment, neuroregulation or energy delivery elements 122 can be for providing the effective electricity for the treatment of and/or the electrode of thermoinducible kidney neuroregulation in intended treatment site delivery of energy.
As hereafter explaining in more detail, curative component 100 is configured to be configured to low section the target blood (such as, Renal vascular) that Ink vessel transfusing mode is delivered to human patients.After being delivered to intended treatment site, curative component 100 is configured to be converted to deployed condition (such as, the distal portions of orbit element 110 is deployed as the configuration of roughly spiral type/spiral schematically shown in Figure 1) to be placed as and blood vessel juxtaposition by orbit element 110 further.Alternately, this deployable state can right and wrong spiral, condition be this deployable state by this orbit element and definitely one or more energy delivery elements 122 be placed as and blood vessel wall juxtaposition, to therapentic part delivery of energy.Then, therapy equipment 120 can be moved slidably along orbit element 110, neuroregulation or energy delivery elements 122 are positioned at desired position (one or more), for regulating the target nerve of next-door neighbour's blood vessel, provide the effective electricity for the treatment of and/or thermoinducible kidney neuroregulation thus.
Use multiple applicable mechanism or technology (such as, oneself launches), curative component 100 can be changed sending between deployable state.In a concrete example, when unrestricted (such as, by regaining guide catheter, aligning (straightening) sheath etc.) time, the distal portions of orbit element 110 can be the preformed self-evolute by being converted to deployable state or arrangement.
The near-end of therapy equipment 120 is carried by the distal portions 20 of slender axles 14 or is attached on it.The far-end of orbit element 110 can comprise noinvasive tip 112.In certain embodiments, the far-end of conduit 12 can comprise for curative component 100 being delivered to the noinvasive tip preventing Ink vessel transfusing wound in therapentic part process.The far-end of conduit 12 also can be configured to another element of mating system 10 or conduit 12.Such as, the far-end of conduit 12 can be defined for the path receiving seal wire, and this seal wire utilizes OTW or exchanges (" RX ") technology delivery treatments device fast.Further details reference Fig. 6 A and 6B about this arrangement is described in hereafter.
This neuroregulation element (one or more) 122 can be electrically coupled to the energy 30 via cable 32, and the energy 30 (such as, RF power generator) can be configured to produce selected form of energy and size, this energy is used for being delivered to therapentic part by the neuroregulation element 122 carried by therapy equipment 120.Just as described in greater detail below, one or more supply lines (not shown) can extend along slender axles 14 or arrive curative component 100 by the inner chamber in axle 14 and neurad regulating element 122 supply treatment energy.
Controlling organization 40, as pedal or hand-held remote control device can be connected to the energy 30, starts to allow clinicist, stops the energy 30 and optionally regulate the different operating characteristic of the energy 30, include but not limited to, electric power transfer.This remote control unit can be positioned in aseptic area and operationally be attached to curative component 100, is exactly attached to neuroregulation element 122, and can be configured to allow clinicist to start or stop neurad regulating element 122 delivery of energy.In other embodiments, this remote control unit can be built in Handleset 18.
The energy or power generator 30 can be configured to via automatic control algorithm 34 and/or under the control of clinicist delivery treatments energy.Such as, the energy 30 can comprise computing equipment (such as, PC, server computer, the panel computer with treatment circuit (such as, microprocessor), etc.), this treatment circuit is configured to the save command performing relevant controlling algorithm 34.In addition, this treatment circuit can be configured to perform one or more assessment/feedback algorithms 35, and these algorithms can be transferred into clinicist.Such as, the energy 30 can comprise monitor or display 36 and/or be configured to provide the correlated characteristic of vision, other instructions of audition or power level, sensing data and/or other feedbacks.The energy 30 also can be configured to feedback and other information to be sent to another device, as the monitor in conduit room.
System 10 also can comprise the one or more additional sensor (not shown) be positioned near neuroregulation element 122 or within it.Such as, system 10 can comprise be connected to one or more supply lines (not shown) temperature sensor (such as, additional thermocouple, critesistor etc.), impedance transducer, pressure transducer, optical pickocff, flow transducer and/or other sensors be applicable to, described supply lines in the future sensor Signal transmissions to and/or conveying capacity to curative component 100.
selected curative component and relevant apparatus example
Fig. 2 is in sending state (such as according to the embodiment of the technology of the present invention, low section or collapsed configuration) the longitudinal cross-section view of a part of endovascular treatment assembly 100, and Fig. 3 A is the perspective view of the curative component 100 of the Fig. 2 being in deployable state or launching configuration in patient's renal artery (or other target blood) RA.As mentioned above, curative component 100 can sending state (Fig. 2) and deployable state (such as, radial development, the configuration of roughly spiral type/spiral, Fig. 3 A) between conversion or activate.
Simultaneously with reference to figure 2 and 3A, curative component 100 comprises and being carried and the therapy equipment 120 engaged with this distal portions slidably by the distal portions of orbit element 110.Therapy equipment 120 comprises and is positioned at its distal portions 124 place or the neuroregulation element 122 near it, and this neuroregulation element is used for destination organization (such as, one or more is neural) the effective energy of delivery treatments to patient.In this deployable state, curative component 100 is configured to the distal portions of orbit element 110 and neuroregulation element 122 to be placed as the inwall juxtaposition with renal artery RA.Therapy equipment 120 comprises and has through the treatment conduit of inner chamber 126 wherein, microtubular or other slender members (such as, sheath), and this inner chamber is defined for the path receiving orbit element 110.When therapy equipment 120 is moved on orbit element 110, orbit element 110 correspondingly provides the guide for this therapy equipment.
With reference to figure 2, and in one embodiment, curative component 100 can be constrained in sending state (such as, configuration that is roughly straight or that shrink) in the inner chamber of tubular sheath or delivery elements 130.Delivery elements 130 can have suitable radial bending rigidity, the distal portions of orbit element 110 is constrained in low section and roughly straight or non-helical configuration (such as, sending state).In certain embodiments, such as, delivery elements 130 can comprise guide catheter or aligning sheath, and this guide catheter or aligning sheath are designed size and are configured as by one or more part constraint of curative component 100 at low profile status, to be delivered to the intended treatment site in renal artery RA.In the low section configuration of shrinking, the geometry of curative component 100 is configured to be convenient to move to therapentic part by delivery elements 130.The technical staff of catheter arts will understand, if delivery elements 130 is guide catheters, then it typically has preformed bending area (not shown) at proximate distal ends place.Therefore, the sending state of curative component 100 will be lowered, that is, transverse section is " low ", but need not to be straight when its bending area through this guide catheter.The flexibility of the curative component 100 in low section configuration is enough to the guide catheter through comprising bending area.In certain embodiments, delivery elements 130 can be that 8Fr or less (such as, the guide catheter of 6Fr) to hold little renal artery in process curative component 100 being delivered to therapentic part.But in other embodiments, delivery elements 130 can have different sizes.
In the certain methods using neural modulation system 10, can instead of delivery elements 130 be utilized to send and dispose catheter in blood vessel 12 on seal wire 50 (in Figure 5).Then, seal wire 50 can be exchanged for orbit element 110 in inner chamber 126, the preformed distal portions of this orbit element will be tending towards taking it spiral-shaped in therapentic part, make therapy equipment 120 be deformed into thus similar spiral-shaped, make at least neuroregulation element 122 be placed as the inwall juxtaposition with renal artery RA.After the inwall of renal artery RA is formed applicable treatment region or infringement, orbit element 110 partially or even wholly can be recalled or be exchanged for seal wire 50 in inner chamber 126, thus allow therapy equipment 120 to relax as more straight configuration, to remove from patient.Those of ordinary skill in the art sends scheme by recognizing for sending and dispose the multiple of curative component 100 at intended treatment site place, and wherein several scheme is further described in hereafter with reference to figure 7 and 8.
As found out in 3A best, after being delivered to intended treatment site (such as, renal artery RA), the distal portions of the orbit element 110 of curative component 100 can be deployed as its helical configuration launched.Such as, in one embodiment, by making delivery elements 130 (such as, sheath; Fig. 2) and curative component 100 relative to each other movement dispose the distal portions of orbit element 110, make the curative component 100 of the distal portions comprising orbit element 110 exceed delivery elements 130 in distal end exposed.The distal portions of orbit element 110 can be configured to take to launch configuration without during inclined (such as, without constraint) situation.Such as, proximally can draw delivery elements 130 (Fig. 2), curative component 100 keeps static relative to therapentic part simultaneously.Alternately, distally can push away the far-end 134 that curative component 100 exceedes delivery elements 130, delivery elements 130 keeps static relative to therapentic part simultaneously.
The helical configuration of the distal portions of orbit element 110 is shown in figure 3b further, and it is the viewgraph of cross-section of the curative component 100 of line 3B-3B along Fig. 3 A.Collective reference 3A and 3B, the distal portions of orbit element 110 defines the helical orbit being tending towards the inwall contacting renal artery RA.In one embodiment, the distal portions of orbit element 110 can have the configuration of the spiral type/spiral pre-set, and makes the distal portions of orbit element 110 oneself in renal artery RA expand into the geometry of deployment.The spiral of orbit element 110 has and is at least substantially equal to renal artery internal diameter D around its central shaft CA 1lateral dimension (Fig. 3 A and 3B) and the greatest length (not shown) on central shaft CA direction that is preferably less than renal artery length or can be held by renal artery length.But in other embodiments, orbit element 110 can have different arrangements and/or different sizes.
In one embodiment, orbit element 110 can from the shape-memory material be applicable to as Nitinol (Nitinol) line be formed.But in other embodiments, orbit element 110 can be made up of different materials and/or have different arrangements.Such as, orbit element 110 can from such as metal wire (such as, rustless steel), shape-memory polymer, electroactive polymer etc. and so on other be applicable to materials formed, these materials are pre-formed or are pre-formed into desired deployable state (Fig. 3 A and 3B).Alternately, orbit element 110 can be formed from multiple material, as the complex of one or more polymer and metal.
Collective reference Fig. 3 A and 3B again, therapy equipment 120 is disposed on the distal portions of orbit element 110, during the shape of the spiral type/spiral making the distal portions when orbit element 110 take it to pre-set, the flexibility of therapy equipment 120 is enough to accord with the spiral-shaped of orbit element 110, makes at least neuroregulation element 122 can be placed as the inwall juxtaposition with renal artery RA.Therapy equipment 120 is removable on the orbit element 110 of geo-stationary, one or more treatment position is located or be repositioned to element 122 along the inwall of renal artery RA.In one embodiment, such as, therapy equipment 120 can comprise flexible pipe 128, and the distal portions of at least preformed spiral type/spiral of orbit element 110 can be received within the inner chamber 126 of pipe 128.Flexible pipe 128 can be made up of polymeric material, and this polymeric material is as polyamide, polyimides, the polyether block amide copolymer sold at trade mark PEBAX, polyethylene terephthalate (PET), polypropylene, the fatty poly-ester carbonate based thermoplastic polyurethane sold under trade mark CARBOTHANE or polyether-ether-ketone (PEEK) polymer.The material behavior of pipe 128 and size are selected as providing necessary flexibility to pipe 128, to be easily out of shape between lax substantially straight shape and another shape, shape disposed by the spiral that this another shape accords with the distal portions of orbit element 110.In other words, pipe 128 has more flexibility than orbit element 110, and the shape of combiner is limited by the shape of orbit element 110.In certain embodiments, inner chamber 126 is designed to be of a size of the enough gaps provided relative to orbit element 110, to reduce the friction between conduit 12 and orbit element 110.In various embodiments, lubricant or lubricant coating (not shown) can be included on slidingsurface any one or both, or can be applied between orbit element 110 and conduit 12, so that relative motion therebetween.
In alternative embodiments, conduit 12 can comprise operating line (not shown), so that push away relative to orbit element 110 or draw therapy equipment 120.This operating line proximally can extend from therapy equipment 120 (such as, the replacement scheme as axle 14), when sending and dispose curative component 100, this therapy equipment, such as, for the clinicist outside patient can and.But in other embodiments, therapy equipment 120 can have different arrangements and/or different features.
In one embodiment, neuroregulation element 122 can be configured to the electrode that delivery of energy (such as, electric energy, RF energy, pulse electric energy, non-pulse electric energy, heat energy, etc.) strides across the wall of renal artery RA.In the particular embodiment, neuroregulation element 122 can send hot RF field to the targeting kidney nerve of the wall of contiguous renal artery RA.Collective reference Fig. 2-3B, neuroregulation element 122 can comprise the band electrode of the far-end 124 around therapy equipment 120, such as, at the far-end of flexible pipe 128.Such as, neuroregulation element 122 can be use adhesives to the band electrode on pipe 128.In other embodiments, therapy equipment 120 can comprise more than one neuroregulation element 122.Such as, device 120 can comprise 2 or 3 electrode (not shown)s, or in another embodiment again, electrod-array, such as a series of band electrode of separating is spaced apart and be bonded on flexible pipe 128 along therapy equipment 120.Although the band shape of illustrating or hollow edged electrode, also disk electrode or plate electrode can be used in other embodiments.In another embodiment again, the electrode with spiral or coil shape can be utilized.Neuroregulation element 122 can be formed from any applicable metal material (such as, the alloy of gold, platinum, platinum and iridium, etc.).But in other embodiments, the number of this neuroregulation element (one or more) 122, arrangement and/or composition can change.Such as, in another position of the near-end of the distal portions 124 of therapy equipment 120, neuroregulation element 122 can be able to be placed in therapy equipment 120.
Neuroregulation element 122 is electrically connected to extra power (as the energy 30, Fig. 1) by extend through the wire of conduit 12 or doublet cord (not shown).Neuroregulation element 122 soldered or otherwise can be electrically coupled to it on energy line, this whole length for the extensible conduit of energy line 12 (such as, the wall of therapy equipment 120 and the inside of axle 14, outside or within), make its near-end be attached to the energy 30 (Fig. 1).In certain embodiments, curative component 100 also can be included in insulating barrier on orbit element 110 (such as, PET or the another kind of material layer be applicable to), to make the material (such as, nitinol wire) of orbit element 110 further with these for energy line (not shown) electric isolution.
In certain embodiments, curative component 100 can comprise radiopaque mark 140 or other labellings, to utilize x-ray imaging technique known in the art to promote assembly 100 to navigate through vascular system and through neuroregulation element 122 being positioned at the one or more desired treatment positions in renal artery RA.Fig. 3 A illustrates wherein radiopaque mark 140 and is contained in the embodiment on the outer surface of the distal portions 124 of therapy equipment 120.(not shown) in other embodiments, orbit element 110 also can comprise radiopaque mark 140 (such as, making with radiopaque ink).In some aspects, can being made up of platinum and/or other radiopaque materials (such as, being wrapped in the platinum/iridium alloy wire coil around slender member) at least partially of orbit element 110 and/or therapy equipment 120.
In operation, and collective reference Fig. 1-3B, the distal portions oneself of orbit element 110 launch or be otherwise deployed as it with the configuration of the juxtaposed spiral type/spiral pre-seted of the inwall of renal artery RA after, therapy equipment 120 can along the orbit element 110 of geo-stationary at near-end or far end party upward sliding, neuroregulation element 122 is positioned at desired treatment position.Then, the effective energy for the treatment of is delivered to the neural (not shown) of kidney of the targeting of one or more treatment site by the wall that can stride across renal artery RA via neuroregulation element 122.Such as, neuroregulation energy can be sent in the first treatment site, make therapy equipment 120 subsequently along orbit element 110 at near-end or far end party upward sliding, neuroregulation element 122 is placed on the second treatment position, this second treatment position is circumference and longitudinally offset transposition along renal artery RA from this first treatment position.After this step, the kidney that energy is delivered to the targeting of this second treatment site by the wall that can stride across renal artery RA via neuroregulation element 122 is neural.Further step can comprise makes therapy equipment 120 slide into one or more additional treatment position along orbit element 110 and again energy is delivered to target nerve.
In certain embodiments, can to leave this first treatment position along renal artery RA on near-end or distal direction longitudinally spaced apart for this second treatment position.Therapy equipment 120 is slided between the first and second treatment positions this second treatment position also can be made relative to the circumferentially translation around blood vessel of this first treatment position.Such as, the spiral path provided along the distal portions by orbit element 110 along with therapy equipment 120 slides (Fig. 3 A), neuroregulation element 122 circumference and longitudinally replacing on the inwall of renal artery RA.Correspondingly, can in one or more discrete treatment position delivery of energy, thus the spiral type infringement pattern formed along renal artery inwall or treatment region.In certain embodiments, these treatment regions can be overlapping.But in other embodiments, these infringements can be sufficiently spaced, make them not overlapping.In embodiment other again, therapy equipment 120 can be made while delivery of energy to slide along spiral path element 110, thus form continuous print or roughly continuous print spiral type infringement.
Fig. 4 A and 4B is the viewgraph of cross-section of the curative component 100 of the different arrangement of the therapy equipment 120 illustrated around orbit element 110.In arranging at one, and as shown in Figure 4 A, orbit element 110 can be the line with approximate circular cross-section shape, and therapy equipment 120 can be the slender member having approximate circular cross-section shape and have the inner chamber 126 for holding track element 110.In this arrangement, therapy equipment 120 can be treatment conduit or other microtubulars with flexible pipe 128, and this flexible pipe is configured to engagement rail element 110 slidably.But Fig. 4 B shows the alternative arrangement that wherein orbit element 110 has substantially rectangular cross sectional shape.Fig. 4 B further depict and do not comprise pipe 128 but the embodiment of therapy equipment 120 in conjunction with non-circumferential sleeve pipe 428, and this non-circumferential sleeve pipe only partly encapsulates orbit element 110.Except the arrangement in figures 4 a and 4b, those of ordinary skill in the art will recognize, the arrangement that other are applicable to can be there is, be configured to be placed as with the juxtaposed track of the inwall of target blood or guide rail for providing and be configured to engage and move the neuroregulation element be connected on it to be positioned at the therapy equipment of multiple treatment position along this track or guide rail slidably.
for sending and dispose the selected example of the method for curative component
Disclose herein and hereafter further discuss some applicable delivering methods; But those of ordinary skill in the art is suitable for curative component 100 to be delivered to therapentic part by recognizing and by the distal portions of orbit element 110 from sending the multiple method that configuration deployment is deployment configuration.About the embodiment of showing in Fig. 1-3B, orbit element 110 is by guide catheter or aligning sheath (delivery elements 130 such as, shown in Fig. 2) or be delivered to therapentic part within it.Can utilize or not utilize seal wire that this sheath is striden across therapentic part to reappose, and orbit element 110 (have or be not mounted to the conduit 12 around it) then can be made through this sheath.Alternately, orbit element 110 (have or be not mounted to the conduit 12 around it) can be pre-loaded in this sheath, makes the parts assembled can travel across the vascular system of patient simultaneously.Under any circumstance, in delivery process, the distal portions of orbit element 110 partially or even wholly can constrain in and send in configuration by this aligning sheath.When the distal portions of orbit element 110 is in target site, this aligning sheath can be recalled or is regained at least in part, is converted to deployment configuration to allow the distal portions of orbit element 110.
Fig. 5 (other reference diagram 1) illustrates at least one step regulating kidney nerve by the embodiment of system 10.Curative component 100 is shown as and is positioned within kidney clump RP and conduit 12 is shown in Ink vessel transfusing path P, and this path extends to the targeted therapy position in corresponding renal artery RA from the percutaneous inlet location femoral artery (displaying), brachial artery, radial artery or axillary artery.As demonstrated, one section of the proximal part 16 of conduit axle 14 is exposed to the outside of patient, even if the curative component 100 targeted therapy position advanced to completely in patient body is also like this.By the proximal part 16 of the outside control lever shaft 14 from Ink vessel transfusing path P, clinicist can make axle 14 travel across sometimes for the Ink vessel transfusing path P of distortion and the distal portions 20 of control lever shaft 14 at a distance.
In the method step shown in Figure 5, use OTW technology, curative component 100 extends to therapentic part in Ink vessel transfusing mode on seal wire 50.Seal wire 50 can comprise any applicable medical guiding wire within the inner chamber 126 that is designed to be of a size of and is engaged in conduit 12 slidably.In a specific embodiment, such as, seal wire 50 can have the diameter of 0.356mm (0.014 inch).When seal wire 50 is for being delivered to therapentic part by curative component 100, by seal wire 50 being exchanged for orbit element 110 within the inner chamber 126 of conduit 12 to complete the deployment of orbit element 110.By the open proximal end exiting the inner chamber 126 at port one 5 place in handle 18 to complete this exchange (see Fig. 1).Therefore, in Figure 5, the element of exposure is marked as seal wire 50 or orbit element 110.
In another kind of delivering method, Fig. 6 A illustrates the viewgraph of cross-section of a part for endovascular treatment assembly 100, and wherein seal wire 50 and orbit element 110 are both disposed within therapy equipment 120.Fig. 6 B is the perspective view of the curative component 100 of Fig. 6 A being in deployable state (such as, launching configuration) within the renal artery RA (or other target blood) of patient.As demonstrated, seal wire 50 and orbit element 110 are both arranged in inner chamber 126 slidably, this inner chamber compared to the one wherein only in seal wire 50 or orbit element 110 be present in inner chamber 126 comparatively early embodiment will be slightly larger inevitably.(not shown) in another embodiment, seal wire 50 and orbit element 110 can be arranged in special inner chamber separately slidably.Seal wire 50 can have enough rigidity, to keep therapy equipment 120 relatively straight, and is constrained in sending state by orbit element 110 thus.Will be appreciated that therapy equipment 120 will be tending towards the shape according with orbit element 110 without the need to providing additional bending rigidity (prior method) by seal wire 50 or delivery elements 130.When treatment site is partly regained or is recalled seal wire 50, as shown in Fig. 6 B, orbit element 110 provides shape recovery force, this shape recovery force is enough to overcome the straightening force provided by the extreme distal end 52 of seal wire 50, orbit element 110 can be deployed in the configuration of its spiral type/spiral-shaped and therapy equipment 120 is out of shape together.In addition, extreme distal end 52 due to seal wire 50 can to remain within curative component 100 (such as at least in part while being in deployable state, Fig. 6 B), seal wire 50 can give additional structural intergrity to the location of spiral section over the course for the treatment of.This feature expection contributes to alleviating or reducing, to therapeutic process, curative component 100 is remained on the relevant problem in appropriate location (such as, contributing to vasoconstriction).
In alternative method step, the seal wire 50 comprising extreme distal end 52 can be recalled completely from curative component 100, be retained within axle 14 (not shown), to allow the conversion of curative component 100 simultaneously.In another method step again, seal wire 50 can be recalled completely from axle 14.In any previous examples, clinicist can recall seal wire 50 fully, so that observe curative component 100 be converted to deployment configuration and/or until the distal tip of radioscopic image display seal wire 50 is in relative to curative component 100 desired locations time (such as, at least partly recall from curative component 100, or recall completely from curative component 100, etc.).In certain methods, seal wire 50 degree of recalling can at least in part based on clinicist about the judgement of selected seal wire and for realize curative component 100 deployment necessity recall degree.
After forming the infringement or treatment region being suitable for realizing neuroregulation, and according to a kind of method, curative component 100 conversion can be turned back to low section and sends configuration (such as, within the inner chamber 126 of therapy equipment 120) by making advance axial relative to curative component 100 of seal wire 50.After seal wire 50 of advancing, orbit element 110 can be recalled from renal artery RA, or in another embodiment, in the inner chamber 126 of therapy equipment 120, seal wire 50 can be exchanged for orbit element 110 (Fig. 6).Once seal wire 50 is in the appropriate location of therapentic part and curative component 100 is in low section sends configuration, can together with seal wire 50 or thereon toward pulling back therapy equipment 120.In a further embodiment, guide catheter or aligning sheath (such as, being shown as delivery elements 130 in fig. 2) axially can be advanced relative to curative component 100, thus orbit element 110 conversion are turned back to and send configuration.In one embodiment, such as, guide catheter or aligning sheath can be made to advance, until when the distal tip of conduit or sheath is roughly alignd with the far-end of orbit element 110.But in other embodiments, the extreme distal end of conduit or sheath can advance to the diverse location relative to curative component 100, thus realize the conversion that orbit element 110 turns back to the configuration of low section.
Image guides, such as, computed tomography (CT) (CT), fluoroscopy, intravascular ultrasound (IVUS), optical coherent tomography (OCT), Intracardiac echocardiography (ICE) or the another kind of bootmode that is applicable to or its combination, can be used for adjuvant clinical doctor location and handle curative component 100.Such as, can make fluoroscopy systems (such as, comprising flat panel detector, x-ray or C-arm) rotate and exactly visual and identify intended treatment site.In other embodiments, IVUS, OCT and/or other image mapped pattern determination therapentic parts be applicable to can be used before delivery catheter 12 and/or curative component 100, this image mapped pattern can by intended treatment site and discernible anatomical structure (such as, spinal column feature) and/or radiopaque scale (such as, be positioned at below patient or above) be associated.In addition, in certain embodiments, image guide member (such as, IVUS, OCT) can integrate with conduit 12, orbit element 110, therapy equipment 120 and/or with conduit 12 parallel running, thus in the location of curative component 100 with remove in process and provide image to guide.Such as, image guide member (such as, IVUS or OCT) at least one in curative component 100 can be attached to, to provide the 3-D view of the vascular system of next-door neighbour's target site, so that curative component 100 is located or is deployed within targeted kidney blood vessel.
Fig. 7 is that displaying is sent above-mentioned curative component 100 with reference to figure 1-6 and is deployed in intended treatment site to regulate the block diagram of the method 700 of kidney nerve.In one embodiment, method 700 can comprise the conduit being in low section and sending configuration is sent in the renal artery of human patients (frame 702) through chamber.Conduit can comprise curative component, the therapy equipment that this curative component comprises orbit element and carried by this orbit element.This therapy equipment can be included in the neuroregulation element of its distal portions.Method 700 also can comprise makes this conduit be deployment configuration (frame 704) from sending configuration transitions.In deployment configuration, this orbit element has the roughly spiral type being configured to this therapy equipment and the neuroregulation element at least carried thereon are close to the radial development that kidney nerve is placed.In arranging at one, this therapy equipment can comprise the sleeve pipe had for receiving the inner chamber through orbit element wherein.When orbit element is the spiral type of radial development, this sleeve pipe is configured to slide on static track, this neuroregulation element is positioned at one or more treatment position along renal artery.
In one embodiment, this conduit can comprise being configured to orbit element to remain on and sends guide catheter in configuration or aligning sheath.Therefore, the step changing this conduit can comprise recalls this guide catheter (or aligning sheath) at least in part to expose the step of orbit element in arteriorenal inner lumen.In certain embodiments, the therapy equipment parts as shown in above Fig. 1-4B and 6 can be configured to be engaged within (such as, 7Fr, 6Fr, etc.) guide catheter of 8Fr or less, to enter little peripheral vessels.In a further embodiment, and as described in reference to figure 5 and 6, method 700 to be optionally included in catheter delivery in seal wire (not shown) to renal artery.In one embodiment, on seal wire, delivery catheter also can be included in this conduit and seal wire is exchanged for curative component.
Method 700 can comprise adjustment kidney nerve (frame 706) further.In this step, can in the first treatment site along renal artery via neuroregulation element to the neural delivery of energy of kidney.Then, therapy equipment can be made to move along the orbit element of geo-stationary, neuroregulation element is positioned at the second treatment position along renal artery, and can at this second treatment position via neuroregulation element to the neural delivery of energy of kidney.Such as, this therapy equipment can be slided, neuroregulation element is positioned at one or more treatment position along renal artery inwall along the orbit element with roughly spiral geo-stationary.This therapy equipment is moved and makes neuroregulation elements relative in arteriorenal longitudinal axis circumference and longitudinally replace.In one embodiment, neuroregulation element can transmitting RF energy, for regulating the kidney of contiguous renal artery inwall neural in the treatment site of targeting.The interruption that can be formed along renal artery inwall in the first and second treatment site delivery of energy is damaged.But, in other embodiments, can in the process of moving treatment device delivery of energy, thus form continuous infringement along this inwall.In some other embodiment, by carrying out the adjustment of kidney nerve in single treatment site via neuroregulation device delivery energy.
Fig. 8 is that displaying is sent above-mentioned curative component 100 with reference to figure 1-6 and is deployed in intended treatment site to regulate the block diagram of the another kind of method 800 of kidney nerve.Such as, method 800 can comprise the treatment site (frame 802) be positioned in Ink vessel transfusing mode by curative component in the target blood of human patients.This curative component can comprise and is in low section and sends the orbit element of configuration and the slender member on this orbit element.This slender member can comprise the electrode being arranged in its distal portions.It is deployment configuration that method 800 also can to comprise this orbit element from sending configuration transitions, and wherein, in this deployment configuration, this orbit element comprises and being tending towards and the juxtaposed helical orbit of target blood inwall (frame 804).In one embodiment, this orbit element can utilize delivery elements (such as, guide catheter, aligning sheath, etc.) and be maintained at and send in configuration, and the step changing this orbit element can comprise and recalls or regain this delivery elements at least in part.Method 800 can comprise further makes slender member slide on orbit element electrode is positioned at treatment site (frame 806) along helical orbit.Method 800 also can comprise the target nerve (frame 808) regulating next-door neighbour's target blood inwall via this electrode delivery of energy.
other embodiment
Above describe and the feature of the pipe guide parts shown in Fig. 1-6B can be modified and formed according to the technology of the present invention configuration other embodiment.Such as, use one or more additional delivery elements, as guide catheter, aligning sheath and/or seal wire, neural modulation system 10 can provide in Fig. 2-4B, 6A and 6B sending of any curative component 100 shown.Similarly, describe and only show additional electrode member, line and the energy that the curative component shown in Fig. 1-3B, 6A and 6B of single neuroregulation element also can comprise along therapy equipment location above and send feature.
Above-mentioned various method step for sending and dispose curative component parts is also interchangeable and form the other embodiment of the technology of the present invention.Such as, although said method step is rendered as given order, alternate embodiment can carry out these steps by different orders.Also other embodiment can be provided by different embodiment combination described herein.
kidney neuroregulation
Kidney neuroregulation is partially or completely anergy or other effective interruption of the nerve of domination kidney.Specifically, kidney neuroregulation comprise suppression, reduce and/or retardance along the neurocommunication of the nerve fiber (that is, spread out of and/or afferent nerve fiber) of domination kidney.Such anergy can be (such as, the period of last for several minutes, a few hours, a couple of days or several weeks) of long-term (such as, the period of permanent or periods of months, several years or many decades) or short-term.Kidney neuroregulation is expected treatment effectively and is characterized as some clinical diseases of overall sympathetic activity increase, and especially relevant to central sympathetic overstimulation disease, as the inappropriate fluid retention in hypertension, heart failure, acute myocardial infarction, metabolism syndrome, insulin resistant, diabetes, left ventricular hypertrophy, chronic and end stagerenaldisease, heart failure, Cardiorenal syndrome, osteoporosis and sudden death.The general that the minimizing of afferent nerve signals facilitates sympatheticotonia/sympathetic drive reduces, and kidney neuroregulation is expected in treatment some diseases relevant to general sympathetic nerve over-activity or hyperkinesia is useful.Kidney neuroregulation may be of value to potentially by multiple organ of sympathetic innervation and body structure.
Various technology can be used to carry out partly or completely to make nervous pathway (such as arranging those paths of kidney) anergy.The energy undertaken by energy delivery elements (one or more) or parts (as in conjunction with those of above-mentioned endovascular treatment component description) (such as, electric energy, heat energy) to the hot heating effect having object to apply can to induce in the adjacent domain of arteriorenal regional area and kidney clump desired by one or more of tissue, this region is closely positioned at arteriorenal adventitia or is close to this adventitia.The object that has of hot heating effect applies the neuroregulation that can realize along all or part of kidney clump.
Hot heating effect can comprise heating ablation and non-melt thermal change or infringement both (such as, via continuous heating and/or resistance heated).Desired hot heating effect can comprise and the temperature of target neural fiber to be elevated to higher than expectation threshold value to realize non-ly melting thermal change, or higher than higher temperature to realize melting thermal change.Such as, melt for thermal change for non-, target temperature can higher than body temperature (such as, roughly 37 DEG C), but lower than about 45 DEG C, or can be about 45 DEG C or higher for melting target temperature for thermal change.
More particularly, the body temperature exceeding about 37 DEG C is exposed to but heat energy (heat) below the temperature of about 45 DEG C can via the appropriate heating of the blood vessel structure of target neural fiber or perfusion target fibers to induce thermal change.Wherein in the affected situation of blood vessel structure, target neural fiber is rejected perfusion, causes the necrosis of nervous tissue.Such as, this can to cause in fiber or structure non-melts thermal change.Be exposed to the temperature higher than about 45 DEG C or the heat higher than about 60 DEG C and may induce thermal change via the remarkable heating of fiber or structure.Such as, such higher temperature with can heat mode ablation targets nerve fiber or blood vessel structure.In some patients, the mode that desirably realizes with heat may be made us but be less than about 90 DEG C or be less than about 85 DEG C or be less than about 80 DEG C and/or the temperature that is less than about 75 DEG C comes ablation targets nerve fiber or blood vessel structure.Regardless of the type being used to the beat exposure of inducing hot neuroregulation, the reduction of renal sympathetic nerve discharge (RSNA) is expection.
conclusion
The above detailed description of the embodiment of this technology is not intended to be limit or the precise forms this Technical Board being limited to above disclosure.Although described above is specific embodiment and the example of this technology for illustration purposes, as related fields such as art will recognize, the various equivalent modifications in the scope of this technology are being possible.Such as, although step is rendered as given order, alternate embodiment can carry out these steps by different orders.Also other embodiment can be provided by different embodiment combination described herein.
According to foregoing teachings, will be appreciated that the specific embodiment describing this technology in this article for purposes of illustration, but not shown or describe the 26S Proteasome Structure and Function known in detail, to avoid the explanation of the embodiment unnecessarily obscuring this technology.When context allows, odd number or plural term also can comprise plural number or singular references respectively.
And, unless word "or" is confined to only mean to get rid of the single project about the sundry item in the inventory of two or more projects clearly, then the use of "or" in such inventory should be interpreted as any single project comprised in (a) inventory, any combination of the project in all items in (b) inventory or (c) inventory.In addition, term " comprises " and is used for from start to finish meaning at least to comprise described feature (one or more), makes not get rid of the same characteristic features of any more big figure and/or other features of addition type.It will also be appreciated that and describe specific embodiment for purposes of illustration herein, but the various amendments not departing from this technology can be made.In addition, although describe the advantage relevant to some embodiment of this technology in the context of those embodiments, but other embodiments also can show such advantage, and not all embodiment all must show such advantage to fall in the scope of this technology.Therefore, this disclosure and correlation technique can contain other embodiments not illustrating clearly or describe herein.

Claims (20)

1. a method, comprising:
Curative component is positioned at the treatment site in the target blood of human patients in Ink vessel transfusing mode, wherein this curative component comprises and is in low section and sends the orbit element of configuration and the slender member around this orbit element, and wherein this slender member comprises the electrode being arranged on its distal portion office;
Being deployment configuration by this orbit element from sending configuration transitions, this orbit element being comprised and is tending towards helical orbit juxtaposed with the inwall of this target blood;
This slender member is slided this electrode is positioned at treatment site along this helical orbit along this orbit element; And
The target nerve of the inwall of this target blood of next-door neighbour is regulated via this electrode delivery of energy.
2. the method for claim 1, wherein this treatment position comprises the first treatment position, and wherein, after being this first treatment site delivery of energy, the method comprises further:
This slender member is slided along this orbit element, makes this electrode be positioned at the second treatment site along this helical orbit, this second treatment position relative to this first treatment position circumferentially and be longitudinally shifted; And
Regulate the target nerve of the inwall of this target blood of next-door neighbour via this electrode delivery of energy in this second treatment site.
3. the method for claim 1, comprises further:
After delivery of energy, this orbit element is converted to this from this deployment configuration and sends configuration; And
This curative component is removed from this patient.
4. the method for claim 1, wherein this orbit element is nitinol wire, and wherein this slender member to be configured in this nitinol wire and to slide, this electrode is positioned at multiple treatment site along this helical orbit along it.
5. the method for claim 1, wherein:
Located to comprise in Ink vessel transfusing mode by this curative component and send this curative component by guide catheter, wherein this guide catheter is configured to this orbit element to be constrained in this and sends in configuration; And
Be that deployment configuration is included in proximal direction and recalls this guide catheter until when this orbit element sends configuration restore to this deployment configuration from this low section in this target blood by this orbit element from sending configuration transitions.
6. the method for claim 1, wherein this orbit element aligning sheath remains on this and sends in configuration, and is wherein that deployment configuration comprises and regains this aligning sheath at least in part relative to this orbit element by this orbit element from sending configuration transitions.
7. the method for claim 1, wherein:
Being comprised with the treatment site that Ink vessel transfusing mode is positioned in target blood by curative component is positioned in the renal artery of this patient by this curative component; And
Comprise via this electrode delivery of energy and send hot radio frequency (RF) energy via this electrode and regulate this arteriorenal kidney contiguous neural.
8., for a method for kidney neuroregulation, the method comprises:
To send being in conduit that low section sends configuration through chamber in the renal artery of human patients and to be close to kidney nerve, wherein this conduit therapy equipment of comprising orbit element and being carried by this orbit element, and wherein this therapy equipment is included in the neuroregulation element of its distal portion office;
By this conduit from sending configuration transitions to deployment configuration, wherein this orbit element has the spiral-shaped of the radial development being configured to be close to this kidney nerve this therapy equipment distal portions of placement and this neuroregulation element;
By following steps regulate this kidney neural-
Along this arteriorenal first treatment site via this neuroregulation element to the neural delivery of energy of this kidney;
This therapy equipment is moved along this orbit element this neuroregulation element is positioned at the second treatment site along this renal artery; And
In this second treatment site via this neuroregulation element to the neural delivery of energy of this kidney.
9. method as claimed in claim 8, before being included in delivery catheter further, seal wire is delivered to this renal artery, and wherein delivery catheter is included on this seal wire and this renal artery is passed in this therapy equipment, then in this therapy equipment, this seal wire is exchanged for this orbit element.
10. method as claimed in claim 8, wherein:
This therapy equipment comprises the sleeve pipe had through inner chamber wherein;
This neuroregulation element is positioned at the distal portion office of this sleeve pipe; And
This orbit element is received in this inner chamber,
Wherein, when this conduit is in this deployment configuration, this sleeve pipe is configured to move on the spiral path of this radial development slidably, this neuroregulation element is positioned at this first treatment position and the second treatment site along this renal artery.
11. methods as claimed in claim 8, comprise further:
This therapy equipment is moved along this orbit element this neuroregulation element is positioned at one or more additional treatment site along this renal artery; And
Neuroregulation energy is sent in each additional treatment site via this neuroregulation element.
12. methods as claimed in claim 8, wherein make this therapy equipment move to make this neuroregulation elements relative in this arteriorenal longitudinal axis circumferentially and longitudinally replace.
13. methods as claimed in claim 8, the interruption wherein defined along this arteriorenal inwall at this first treatment position and the second treatment site delivery of energy is damaged.
14. methods as claimed in claim 8, wherein comprise can the line of radial development for this orbit element.
15. 1 kinds of equipment for neuroregulation, this equipment comprises:
Conduit, carries out Ink vessel transfusing placement in the target blood that this conduit is configured in human patients;
Curative component, this curative component is in the distal portion office of this conduit, wherein this curative component slender member of comprising orbit element and being carried slidably by this orbit element, and wherein this slender member comprises the neuroregulation element be arranged in around its distal portions;
Wherein this orbit element is configured to send configuration oneself from low section and expands into the deployment configuration with preformed helical structure, and this helical structure is designed size and this neuroregulation element is orientated as and one or more treatment position juxtaposition by the inwall be configured as along this target blood.
16. equipment as claimed in claim 15, wherein this orbit element comprises nitinol wire, and wherein this slender member comprises the sheath being configured to cover this nitinol wire at least in part.
17. equipment as claimed in claim 15, wherein this neuroregulation element is first nerves regulating element, and wherein this slender member comprises the isolated nervus opticus regulating element with this first nerves regulating element.
18. equipment as claimed in claim 15, wherein this conduit is guide catheter, and wherein this guide catheter is configured to this orbit element radially to be constrained in this and sends in configuration, this curative component is positioned in this target blood in Ink vessel transfusing mode simultaneously, and further, wherein this guide catheter makes this orbit element be discharged into this deployment configuration relative to the near-end withdrawal of this curative component.
19. equipment as claimed in claim 15, wherein this neuroregulation element comprises the distal portion office that is arranged in this slender member and is configured to send the electrode of hot radio frequency (RF) energy.
20. equipment as claimed in claim 15, comprise further for pushing away relative to this orbit element or drawing the operating line of this slender member.
CN201480053726.XA 2013-09-30 2014-09-17 Intravascular neuromodulation device having a spiral track and associated methods Pending CN105578982A (en)

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