WO2014176785A1

WO2014176785A1 - Nerve regulation device

Info

Publication number: WO2014176785A1
Application number: PCT/CN2013/075137
Authority: WO
Inventors: 秦杰; 汪立; 盛卫文; 王国辉; 吴艳雪
Original assignee: 上海安通医疗科技有限公司
Priority date: 2013-05-03
Filing date: 2013-05-03
Publication date: 2014-11-06

Abstract

Disclosed is a nerve regulation device, comprising a regulating assembly for nerve regulation, wherein the regulating assembly comprises one or more electrodes (101) for delivering a regulating energy to the nerve and an electrode-bearing component (102) for bearing the one or more electrodes, wherein the electrode-bearing component (102) has a first shape and a second shape; with the first shape, the regulating assembly is suitable for moving in a blood vessel, while with the second shape, at least one electrode (101) of the regulating assembly is in a position suitable for delivering the regulating energy to the nerve. The device also comprises a control assembly (200) for transporting the regulating assembly to a position close to the nerve and enabling the electrode-bearing component to switch between the first shape and the second shape. The nerve regulation device is convenient in operation and is able to simultaneously regulate multiple nerve sites, improving the working efficiency.

Description

Device for regulating nerves

Technical field

The present invention relates to electrosurgery, and more particularly to a device for modulating nerves.

Background technique

Refractory hypertension, a condition that is still difficult to control with more than three drugs (both already using a diuretic) (sBP ≥ 160mmHg), more common in clinical, its pathogenic factors are numerous, the pathogenesis is not clear, the drug treatment effect is very poor, and the diagnosis and treatment techniques are still not mature enough, which has become one of the major problems in the treatment of hypertension.

Recent animal and clinical trial data demonstrate that regulation of renal nerves (such as desympathetic nerves) can significantly and permanently reduce refractory hypertension, such as the recently developed renal artery radiofrequency ablation. Radiofrequency ablation of the renal artery is an interventional technique that achieves denervation by delivering a lead through a blood vessel into a specific part of the renal artery, releasing radiofrequency currents and causing local coagulative necrosis of the renal artery. The RF current damage range is small and does not cause harm to the body. Therefore, renal artery radiofrequency ablation has become an effective method for removing renal artery sympathetic nerves.

In addition, the regulation of renal nerves has been shown to have a certain effect on a variety of kidney-related diseases, especially related diseases caused by excessive activation of renal sympathetic nerves. For example, congestive heart failure (CHF ) can lead to abnormally high renal sympathetic activation, resulting in a decrease in water and sodium removed from the body and an increase in renin secretion. Increased renin secretion leads to renal vasoconstriction, causing a decrease in renal blood flow. Thus, the kidney's response to heart failure can prolong the spiral decline in heart failure conditions.

Although related instruments for regulating renal sympathetic nerves have been reported in related literatures or patents, currently existing devices have drawbacks such as inconvenient operation, high manufacturing cost, or inefficiency.

In view of this, the present invention provides a new device for regulating nerves.

Summary of the invention

It is an object of the present invention to provide an apparatus for regulating nerves and treating related diseases with ease of operation.

Apparatus for modulating a nerve provided by the present invention, comprising an adjustment assembly for modulating the nerve, the adjustment assembly comprising one or more electrodes for delivering modulating energy to the nerve and for carrying the An electrode carrying member of an electrode, characterized in that the electrode carrying member has a first shape and a second shape, the adjusting member being adapted to move in a blood vessel in the first shape, the adjusting in the second shape At least one electrode of the assembly is in a position suitable for transmitting the modulated energy to the nerve; the device further comprising means for delivering the adjustment assembly to a position proximate the nerve and the electrode bearing member at a first A control component that transforms between the shape and the second shape.

Preferably, the nerve is a renal nerve located on a human renal artery, and the 'position close to the nerve' refers to being located in the renal artery .

Preferably, said modulation refers to the removal or reduction of activation of said nerve by means of injury or non-injury.

Preferably, the energy is one or more of heat, cooling, electromagnetic energy, radio frequency, ultrasonic wave, microwave or light energy.

Preferably, the blood vessel is a human renal artery.

Preferably, said 'suitable for moving in a blood vessel' means said adjustment assembly when said adjustment assembly moves in a blood vessel Does not damage the vessel wall.

Preferably, said 'suitable for moving in a blood vessel' refers to said adjustment component The largest dimension in the radial direction of the blood vessel is not greater than the inner diameter of the blood vessel.

Preferably, said 'suitable for moving in a blood vessel' means that the maximum dimension of the adjustment component in the radial direction of the blood vessel is not more than 4 mm .

Preferably, said 'suitable for transferring said modulated energy to said renal nerve' means that when said regulating member is in a blood vessel, At least one of the electrodes is in contact with the vessel wall.

Preferably, said 'suitable for transferring said modulated energy to said renal nerve' refers to said adjustment component The largest dimension in the radial direction of the blood vessel is 4-8 mm, and at least one electrode is at the largest dimension.

Preferably, The adjustment assembly includes a plurality of electrodes, the plurality of electrodes of the adjustment assembly being in a position suitable for transmitting the modulated energy to the nerve.

Preferably, the inside of the electrode carrying member is provided with a wire for connecting the electrode to the energy generating device.

Preferably, the electrode is annular or tubular and is sleeved on the outside of the electrode carrying member.

Preferably, the second shape is an shape of the electrode carrying member that is not subjected to an external force.

Preferably, a marking member for displaying the position of the electrode carrying member under X-rays is disposed near the distal end or the distal end of the electrode carrying member.

Preferably, the distal end of the electrode carrying member is provided with a protective member for reducing or avoiding damage to the blood vessel wall. More preferably, the material of the protective member is softer than the material of the electrode carrying member.

Preferably, the first shape of the electrode carrying member is one of an elongated shape, a strip shape, a filament shape or a fiber shape.

Preferably, the second shape of the electrode carrying member is a spiral shape. More preferably, the spiral has a diameter of 4-8 mm.

Preferably, the number of the electrodes is 2-6, when When the electrode carrying member is in the second shape, the distance between adjacent electrodes in the axial direction of the blood vessel is 4-6 mm. More preferably, the number of the electrodes is four.

Preferably, said control component includes means for said a delivery member that is delivered to a position near the nerve, the delivery member being in the form of an elongated, strip, filament or fiber, the distal end of the delivery member and the electrode bearing member The proximal end is connected. More preferably, The conveying member and the electrode carrying member are made of the same material and integrated. In addition, The delivery member preferably has a length that enables delivery of the adjustment assembly from the human iliac artery to the human renal artery. More preferably, the conveying member has a length of from 130 cm to 160 cm.

Preferably, the control assembly includes a shape control member for transforming the electrode carrying member between a first shape and a second shape.

Preferably, said The inside of the electrode carrying member and the conveying member has a shape control passage for accommodating the shape control member, the shape control member is located in a shape control passage of the conveying member, the electrode carrying member and the shape control The component is configured to utilize the shape control member to control the passage of the shape of the electrode carrier member to control the passage of the electrode carrier member between the first shape and the second shape. More preferably, The associated control assembly includes a handle for a user to grip, the delivery member being mounted to the handle, the handle having A shape control passage accommodating the shape control member, the shape control member extending to the outside of the handle through a shape control passage of the handle.

Preferably, the shape control member is sheathed to the conveying member and slidable along the conveying member, The electrode carrying member and the shape controlling member are configured to: when the shape controlling member is sheathed to the electrode carrying member and the electrode, the electrode carrying member is in a first shape when The electrode carrying member is in a second shape when the shape controlling member is detached from the electrode carrying member and the electrode. more Preferably, the control assembly includes a handle for a user to grip, the delivery member being mounted to the handle. Alternatively, the shape control member is disposed near the distal end or the distal end for displaying the shape control member under X-rays Marking component of position.

The device for regulating nerves provided by the invention is convenient to operate, and can simultaneously adjust a plurality of nerve sites, thereby improving work efficiency.

The concept, the specific structure and the technical effects of the present invention will be further described in conjunction with the accompanying drawings in order to fully understand the objects, features and effects of the invention.

DRAWINGS

Figure 1 is a schematic diagram of the structure of human kidney and related tissues.

Figure 2 is a schematic view of the structure of the human renal artery.

image 3 It is a schematic diagram of a component of a specific embodiment of the apparatus for modulating nerves provided by the present invention, which shows the first shape of the electrode carrying member.

Figure 4 is shown in Figure 3. A schematic view of another state of the device for modulating nerves, the figure showing the second shape of the electrode carrying member.

Figure 5 is a schematic view showing the structure of the device for adjusting nerves shown in Figure 3.

6 is a schematic structural view of another embodiment of the apparatus for modulating nerves provided by the present invention.

detailed description

The invention will be further described below in conjunction with the drawings and specific embodiments. For ease of illustration, in the present invention, the end of the device or component that is adjacent to the user (or handle) or away from the nerve site that needs to be adjusted is referred to as the 'proximal end', and that the device or component is remote from the user (or handle) or near. One end of the nerve site that needs to be regulated is called the 'distal'.

Figures 1 - 5 illustrate a preferred embodiment of the apparatus for modulating nerves and methods of use thereof provided by the present invention. This embodiment is exemplified by a device for regulating human renal nerves.

Figure 1 - Figure 2 shows the relevant tissues and structures of the human kidney. As shown in Figure 1, human kidney-related tissue anatomically includes kidney K, kidney K Oxygenated blood is supplied through the renal artery RA. The renal artery RA is connected to the heart via the aorta AA of the abdomen. Deoxygenated blood flows from the kidney to the heart via the renal vein RV and the inferior vena cava IVC. figure 2 A more detailed map of the kidney anatomy. More specifically, the renal anatomy also includes a renal nerve RN extending longitudinally along the axial direction L of the renal artery RA. Renal nerve RN Typically within the outer membrane of the artery. In this embodiment, the device is provided for modulating renal nerve RN located on the renal artery RA, said adjustment to remove or reduce renal nerves by injury or non-injury RN Activation. As a variation of this embodiment, if it is desired to modulate nerves at other sites (eg, heart-related nerves), or other modes of adjustment are needed (eg, further activation of the nerves is required), those skilled in the art can make according to the present invention. Adjustments that are reasonably expected and do not require creative labor.

Figures 3 and 4 show the components of the device for modulating nerves in this embodiment. Figure 3 and Figure 4 As shown, the device first includes an adjustment assembly 100; the adjustment assembly 100 includes an electrode 101 and an electrode carrying member 102. . When the electrode is close to the nerve site to be regulated, the electrode releases a certain amount of energy and acts on the nerve site, thereby regulating the nerve site (eg, reducing or eliminating the activation of the sympathetic nerve).

The electrode can achieve this by transferring heat to the nerve site. For example, a heat transfer heating mechanism for neuromodulation can include thermal ablation and non-ablative thermal changes or damage, for example, the temperature of the target nerve fiber can be raised beyond a desired threshold to achieve a non-ablative thermal change, or more High temperatures to achieve thermal changes in ablation. For example, the target temperature can be around 37 ° C - 45 ° C (for the thermal temperature of non-thermal ablation), or the target temperature may be about 45 ° C or higher for the thermal change of ablation.

The electrode can also accomplish this by delivering cooling to the nerve site. For example, reducing the temperature of the target nerve fiber to about 20 Below °C to achieve non-freezing thermal changes, or to lower the temperature of the target nerve fibers to below about 0 °C to achieve the thermal change of freezing.

Electrodes can also be achieved by applying an energy field to the target nerve fibers. The energy field may include: electromagnetic energy, radio frequency, ultrasonic waves (including high intensity focused ultrasound), microwave, light energy (including laser, infrared, and near infrared). For example, thermally induced neuromodulation can be achieved by delivering a pulsed or continuous thermal energy field to the target nerve fibers. Among them, a more preferred energy mode is a pulsed RF electric field or other types of pulsed thermal energy. Pulsed RF electric fields or other types of pulsed thermal energy can contribute to greater heat levels, longer total duration, and / or better controlled intravascular renal neuromodulation therapy.

Regardless of the energy source for the purpose of modulating the nerves, when the user is working with the device provided by the present invention, the electrodes need to be electrically connected to the device that produces the energy (eg, a radio frequency meter) or causes the electrode itself to generate the energy. These devices and the connection of the electrodes to these devices are prior art well known to those skilled in the art (for example, an interface for connecting these devices is provided in the device of the present invention, which enables plug and play when used), and is no longer here. Detailed description.

In this embodiment, the electrode 101 The way to close the renal nerve site to be adjusted is to enter the human body through the blood vessel and approach the nerve site through the inner wall of the renal artery. Therefore, when working with the device provided by the specific embodiment, a technical problem to be solved is that it is necessary to realize that the electrode can be closely attached to the inside of the blood vessel to act on the nerve at the corresponding position, and the electrode can be conveniently moved in the blood vessel. And does not damage the vessel wall. This specific embodiment solves this technical problem by adopting the following technical solution: configuring the electrode carrying component 102 has a first shape (as shown in Figure 3) and a second shape (as shown in Figure 4). Figure 3 As shown, the first shape is a straight or nearly straight strip (or elongated or fibrous or filamentary), the cross section of the strip preferably being circular or approximately circular, with the widest portion of the cross section being less than The inner diameter of the blood vessel. In this way, under the first shape, when When the adjustment assembly 100 is moved in the blood vessel, the adjustment assembly 100 does not damage the vessel wall. When the nerves on the renal artery need to be adjusted, since the inner diameter of the human renal artery is generally 4-7 mm, The maximum dimension of the adjustment component 100 in the radial direction of the renal artery is no more than 4 mm, preferably 1-2 mm. It can satisfy the convenient movement in the blood vessel, has sufficient rigidity and is easy to manufacture, and can reduce the size of the wound of the patient. As a variation of this embodiment, the first shape may also allow for a certain bending or wavy bending, and the cross section may be other shapes as long as the surface is smooth and can be easily moved within the blood vessel without damaging the blood vessel wall. can.

In the second shape of the electrode carrying member, the electrodes of the conditioning assembly 100 are in a position suitable for delivering modulated energy to the renal nerves. Figure 4 As shown, in this embodiment, the second shape of the electrode carrying member 102 is entirely helical. When the electrode carrying member 102 is spiral in its entirety, in the radial direction of the blood vessel (perpendicular to the axial direction of the blood vessel), the adjustment assembly The widest point of 100 is larger than the first shape so that the electrodes carried can be brought close to or in contact with the vessel wall, thereby being close to the renal nerve. After groping, considering that the blood vessels have a certain elasticity, the diameter of the spiral is set to 4-8mm. More suitable. For example, for individuals with a small inner diameter of the renal artery (for example, an inner diameter of about 4 mm), the diameter of the spiral can be set to about 5 mm; for individuals with a large inner diameter of the renal artery (for example, an inner diameter of 7 mm) Left and right), the diameter of the spiral can be set to about 8mm. As a variation of this embodiment, the second shape may also be other shapes, for example, a random shape having a smooth curvature, as long as the electrode carrying member is in a blood vessel, the electrode It is only in the position of contacting the blood vessel wall.

In this embodiment, the electrode 101 is annular and sleeved on the outer surface of the electrode carrying member 102. In this way, when the electrode carrying part When the 102 is spiral (in the renal artery), the electrode 101 on the electrode carrying member 102 is in contact with the inner wall of the renal artery (near the renal nerve), so that adjustment work can be performed. In order to make the electrode 101 Firmly mounted on the electrode carrying member 102 and minimizing damage to the blood vessel wall, an annular recess having a shape matching the electrode 101 may be provided on the outer surface of the electrode carrying member 102, and the electrode 101 Fixed in the corresponding position. In addition, the outer surface of the electrode 101 and the adjacent electrode carrying member 102 The outer surface of the area forms a relatively smooth curved surface to reduce damage to the vessel wall. As a variation of this embodiment, the electrode 101 can also be mounted on the electrode carrying member 102 by other means, for example, an electrode. 101 is block-shaped and embedded in the outer surface of the electrode carrying member 102. In addition, the inside of the electrode carrying member 102 is provided with an electrode 101 for A wire (not shown) connected to an energy generating device (for example, a radio frequency meter), when having a plurality of electrodes, requires a plurality of wires each connecting a plurality of electrodes to the energy generating device. Electrode bearing member 102 Elements for measuring temperature (for example, thermocouples) and corresponding wires can also be provided, and the arrangement of wires and thermocouples is a conventional arrangement in the art and will not be described in detail herein.

In this embodiment, the number of electrodes 101 is four. When the electrode carrying member 102 In the second shape (helical shape), it is preferable that the distance D of the adjacent electrodes in the axial direction of the blood vessel is 4-6 mm. In general, when performing renal nerve ablation surgery, 5-8 of the renal nerves One site is ablated. Therefore, when working with the device in the embodiment, the positioning of the primary adjustment component (with the electrode contacting the inner wall of the blood vessel) can complete the ablation of the four sites, and the entire ablation procedure requires only two adjustment components to be positioned. can. As a variation of this embodiment, the number of electrodes can also be set to 2-6 However, if the number is large, the production cost of the entire device will be increased; if the number is small, the work efficiency of the ablation operation can be reduced. The material of the electrode may be a metal or metal alloy which is more biocompatible or relatively stable, such as a platinum group metal such as a platinum rhodium alloy.

In this embodiment, the distal end of the electrode carrying member 102 is further provided with a marking member 103 and a protective member 104. Marking component The role of 103 is to display the position of the electrode-carrying component under X-ray. The material can be selected from a metal or metal alloy with better biocompatibility or stability, such as a platinum group metal (such as platinum-rhodium alloy). Marking part 103 It may also be annular and sleeved on the outer surface of the distal end of the electrode carrying member 102. The function of the protective member 104 is to reduce or avoid damage to the blood vessel wall, and the protective member 104 It may be connected to the electrode carrying member 102 for a piece of material which is relatively soft (for example, a relatively soft plastic polymer such as Pebax2533, Pebax3533, TPU, etc.). The distal end prevents the distal end of the electrode carrying member 102 from damaging the blood vessel.

The apparatus in this embodiment further includes a control assembly 200 that includes an adjustment assembly 100 A delivery member 201 that is delivered to a position near the renal nerve (i.e., delivered into the renal artery) and a shape control member 202 that changes the electrode carrier member 102 between the first shape and the second shape (Fig. 3 and Fig. 3) 4)). Fig. 5 shows the structure of the conveying member 201 and the shape controlling member 202. As shown in Fig. 5, the distal end of the delivery member 201 and the electrode carrying member 102 The proximal ends are connected, and if they are made of the same material, they can be integrally formed. Conveying part 201 The shape is strip (or slender or fibrous or filiform) with rigidity and bendability suitable for movement in blood vessels, the length of which can be set as desired. For example, if the user needs to pass the transfemoral artery to adjust the assembly 100 Delivery into the renal artery, the delivery member 201 can be configured to have a length of between 80 cm and 130 cm (about 105 cm is most suitable); if the user needs to pass the transarterial artery, the adjustment assembly 100 The delivery member 201 can be disposed in the renal artery and has a length of 130 cm to 160 cm (about 155 cm is most suitable). Conveying part 201 The cross section is preferably circular, and the diameter thereof is not larger than the inner diameter of the blood vessel to be passed, and the diameter is preferably about 1-2 mm. It can satisfy the convenient movement in the blood vessel, has sufficient rigidity and is easy to manufacture, and can reduce the size of the wound of the patient.

In this embodiment, the electrode carrying member 102 and the conveying member 201 are internally provided for accommodating the shape controlling member 202. The shape control passage 202 has a strip shape (or an elongated shape or a fiber shape or a filament shape), a straight or nearly straight strip shape near the far portion, and the shape control member 202 penetrates the conveying member 201. The entire shape controls the passage and extends beyond the proximal end of the delivery member 201. Further, the second shape of the electrode carrying member 102 is the shape of the electrode carrying member when it is not subjected to an external force, and the electrode carrying member 102 Made of elastic memory material. That is, the electrode carrying member 102 is entirely spiral in shape without being subjected to an external force. The specific embodiment adopts the following technical scheme to control the electrode carrying member 102. The first shape and the second shape are changed: the shape control member 202 is made of a material harder than the material of the electrode carrying member, for example, the electrode bearing member 102 is made of a polymer plastic (e.g., Pebax3533, Pebax4033, TPU, etc.), an elastic memory material nickel-titanium wire is provided inside or on the inner wall of the polymer plastic (guarantee electrode carrying member 102) The shape control member 202 is made of stainless steel when it is not subjected to an external force, and the shape control member 202 is made of stainless steel; thus, the user can pinch the proximal end of the shape control member 202 (exposed to the conveying member 201). The outer and outer operations of the push and pull back cause the shape control member 202 to enter and exit the shape control channel of the electrode carrier member 102; when the shape control member 202 enters the electrode carrier member 102 When the shape control channel is formed, since the hardness of the material of the shape control member 202 is larger than that of the electrode carrying member 102, the shape control member 202 The first shape (straight or nearly straight strip shape) will be exhibited; when the shape control member 202 is disengaged from the shape control passage of the electrode carrying member 102, due to the electrode carrying member 102 With its own elastic force, the electrode carrying member 102 returns to the second shape (helical shape); thereby, the electrode carrying member 102 is changed between the first shape and the second shape.

In addition, in this embodiment, the control assembly 200 further includes a handle 203 suitable for the user to hold for the convenience of the user. The conveying member 201 is mounted to the handle 203, and the handle 203 also has a shape control passage for accommodating the shape control member 202, and the shape control member 202 passes through the handle 203. The shape control passage extends to the outside of the handle 203 for the user to push and pull back the shape control member 202.

When the inside of the electrode carrying member 102 and the conveying member 201 need to accommodate the shape controlling member 202 at the same time And a plurality of wires (such as described above, when the electrode carrying member 102 When carrying a plurality of electrodes thereon, and when an element such as a thermocouple is further provided, when it is necessary to connect the electrodes and the elements to the respective devices with a plurality of wires, a preferred mode is at the electrode carrying member 102 and the conveying member 201. Two or more independent channels are provided, and the shape control member 202 uses one of the independent channels, and the wires use one or more other channels (as long as the wires are insulated from each other).

One specific embodiment of the shape control component 202 has been described above. As a variation of this embodiment, shape control component 202 The electrode carrying member 102 can also be varied between the first shape and the second shape by another means. As shown in FIG. 6, the shape control unit 202 In the form of a strip (or elongated or fibrous or filamentous), the portion near the distal end is a straight or nearly straight strip-shaped tubular body which is jacketed on the outside of the conveying member 201 and slidable along the conveying member 201 . Shape control unit 202 is made of a material that is harder than the material of the electrode carrying member 102. For example, the electrode carrying member 102 is made of a relatively soft polymer plastic (such as Pebax3533, Pebax4033, TPU, etc.), the shape control part 202 is made of relatively hard polymer plastic (such as ABS, PC, etc.); thus, the user can hold the shape control part The proximal end of 202 performs push and pull back operations such that shape control component 202 is overlaid on electrode carrier component 102 and off electrode carrier component 102; when shape control component 202 When the outer surface of the shape control member 202 is harder than the electrode carrying member 102, the shape control member 202 is coated on the electrode carrying member 102. The first shape (straight or nearly straight strip shape) is exhibited; when the shape control member 202 is detached from the electrode carrying member 102, the electrode carrying member 102 is due to the elastic force of the electrode carrying member 102 itself. The second shape (spiral shape) is restored; thereby, the electrode carrying member 102 is changed between the first shape and the second shape. In addition, the distal end or the distal end of the shape control member 202 can also be set for use in X The marking member at the position of the shape controlling member 202 is displayed under light to prevent the shape controlling member 202 from excessively protruding beyond the electrode carrying member 102 at the time of surgery, thereby damaging the kidney tissue.

The above describes a specific embodiment of the apparatus for modulating nerves provided by the present invention. It should be understood that many modifications and variations can be made in accordance with the inventive concept without departing from the scope of the invention. Neuromodulation and therapy can be achieved as long as the conditioning assembly can be delivered via a blood vessel to a nerve site adjacent to the adjustment and the shape control member is operated such that the electrode carrier member changes between the first shape and the second shape. For example, you can refer to the application number as Some of the solutions disclosed in the Chinese Patent Application No. 200780031879.4 and 200980157662.7 achieve this purpose, in particular by using the provided device to drive the movement of the shape control member. Therefore, any technical solution that can be obtained by a person skilled in the art based on the prior art based on the prior art by logic analysis, reasoning or limited experimentation should be within the scope of protection determined by the claims.

Claims

A device for modulating a nerve, comprising an adjustment assembly for modulating the nerve, the adjustment assembly comprising one or more electrodes for delivering modulating energy to the nerve and an electrode for carrying the electrode a carrier member, characterized in that the electrode carrying member has a first shape and a second shape, the adjustment member being adapted to move in a blood vessel in the first shape, and at least the adjustment member in the second shape An electrode is in a position suitable for delivering the modulated energy to the nerve; the device further comprising means for delivering the adjustment assembly to a position proximate the nerve and causing the electrode carrier member to be in a first shape and A control component that transforms between two shapes.
The device according to claim 1, wherein said nerve is a renal nerve located on a human renal artery, said "position near said nerve" being located within said renal artery.
The device according to claim 1, wherein said regulating means removing or reducing activation of said nerve by means of injury or non-injury.
The device according to claim 1, wherein said energy is one or more of heat, cooling, electromagnetic energy, radio frequency, ultrasonic waves, microwaves or light energy.
The device of claim 1 wherein said blood vessel is a human renal artery.
The device of claim 1 wherein said "suitable for movement in a blood vessel" means that said adjustment assembly does not damage the vessel wall as said adjustment assembly moves within the blood vessel.
The device according to claim 1, wherein said "suitable for movement in a blood vessel" means that the maximum dimension of said adjustment assembly in the radial direction of said blood vessel is not greater than the inner diameter of said blood vessel.
The device according to claim 1, wherein said "suitable for moving in a blood vessel" means that said adjustment member has a maximum dimension in the radial direction of said blood vessel of not more than 4 mm.
The device according to claim 1, wherein said "suitable for transmitting said modulated energy to said renal nerve" means that at least one electrode is in contact when said regulating member is in a blood vessel The location of the vessel wall.
The device according to claim 1, wherein said "the position suitable for transmitting said modulated energy to said renal nerve" means that the maximum dimension of said adjustment member in the radial direction of said blood vessel is 4-8mm, at least one electrode is at the maximum size.
The device of claim 1 wherein said adjustment assembly comprises a plurality of electrodes, said plurality of electrodes of said adjustment assembly being adapted to deliver said modulated energy to said nerve in said second shape s position.
The device according to claim 1, wherein the inside of the electrode carrying member is provided with a wire for connecting the electrode to the energy generating device.
The device according to claim 1, wherein said electrode is annular or tubular and is sleeved outside said electrode carrying member.
The device according to claim 1, wherein said second shape is an shape of said electrode carrying member that is free from an external force.
The device according to claim 1, wherein a marking member for displaying the position of the electrode carrying member under X-rays is provided near the distal end or the distal end of the electrode carrying member.
The device according to claim 1, wherein the distal end of the electrode carrying member is provided with a protective member for reducing or avoiding damage to the blood vessel wall.
The device according to claim 16, wherein the material of the protective member is softer than the material of the electrode carrying member.
The device according to claim 1, wherein the first shape of the electrode carrying member is one of an elongated shape, a strip shape, a filament shape or a fiber shape.
The device according to claim 1, wherein the second shape of the electrode carrying member is a spiral shape.
The device according to claim 19, wherein said spiral has a diameter of 4-8 mm.
The device according to claim 1, wherein the number of said electrodes is 2-6, and the distance of adjacent electrodes in the axial direction of said blood vessel when said electrode carrying member is in a second shape It is 4-6mm.
The device according to claim 21, wherein the number of the electrodes is four.
The device according to claim 1 wherein said control assembly includes a transport member for transporting said adjustment assembly to a position adjacent said nerve, said transport member being elongate in shape and strip shaped A filamentous or fibrous one, the distal end of the delivery member being coupled to the proximal end of the electrode carrier member.
The apparatus according to claim 23, wherein said conveying member and said electrode carrying member are made of the same material and integrated.
The device of claim 23 wherein said delivery member has a length capable of delivering said adjustment assembly from a human iliac artery to a human renal artery.
The device according to claim 25, wherein said conveying member has a length of from 130 cm to 160 cm.
The device according to claim 23, wherein said control assembly comprises a shape control member for transforming said electrode carrying member between a first shape and a second shape.
The apparatus according to claim 27, wherein said electrode carrying member and said conveying member have a shape control passage for accommodating said shape controlling member, said shape controlling member being located at said conveying member In the shape control passage, the electrode carrying member and the shape control member are configured to use the shape control member to control the passage of the shape of the electrode carrying member to allow the electrode carrying member to be in the first shape and The shape changes between the two.
30. Apparatus according to claim 28 wherein the associated control assembly includes a handle for a user to grip, the delivery member being mounted to the handle, the handle having a shape control passage for receiving the shape control member The shape control member extends to the outside of the handle through a shape control passage of the handle.
The device according to claim 27, wherein said shape control member is sheathed to said transport member and slidable along said transport member, said electrode carrying member and said shape control member being configured when said The electrode carrying member is in a first shape when the shape controlling member is sheathed to the electrode carrying member and the electrode, and the electrode carrying member is in a second shape when the shape controlling member is separated from the electrode carrying member and the electrode.
30. Apparatus according to claim 30 wherein said control assembly includes a handle for a user to grip and said delivery member is mounted to said handle.
30. Apparatus according to claim 30 wherein a vicinity of the distal end or distal end of the shape control member is provided with a marking member for displaying the position of the shape control member under X-rays.