CN205433879U - Radiofrequency ablation catheter for renal arteries - Google Patents

Abstract

The utility model discloses a catheter for renal artery radiofrequency ablation, which comprises an adjustment assembly for adjusting the nerve, the adjustment assembly includes an electrode and a bearing part for carrying the electrode, the electrode is used to transmit the adjustment energy to the nerve, and the electrode includes a winding The electrode wire on the carrying part, the carrying part has a first shape and a second shape, in the first shape, the adjustment assembly is configured to move in the blood vessel; in the second shape, the electrode is in a shape suitable for transferring the adjustment energy to The location of the nerve. Compared with the prior art, the extension length of the electrodes on the bearing part is longer, which makes the renal artery radiofrequency ablation catheter of the present invention have better ablation effect.

Description

Catheter for radiofrequency ablation of renal artery

technical field

The utility model relates to electrosurgery, in particular to a renal artery radiofrequency ablation catheter.

Background technique

Refractory hypertension, high blood pressure (sBP ≥ 160mmHg) that is difficult to control even after using 3 or more drugs (all of which have used a diuretic), is relatively common in clinical practice, with many pathogenic factors and unclear pathogenesis. The treatment effect is very poor, and the diagnosis and treatment techniques are still immature, which has become one of the major problems in the treatment of hypertension.

The latest animal and clinical experimental data prove that the regulation of renal nerves (such as denervation) can significantly and permanently reduce resistant hypertension, such as the recently developed radiofrequency ablation of renal arteries. Renal artery radiofrequency ablation is an interventional technique that achieves denervation by sending an electrode catheter into a specific part of the renal artery through blood vessels, releasing radiofrequency current to cause local coagulation necrosis of the sympathetic nerve of the renal artery. The damage range of radiofrequency current is small and will not cause harm to the body. Therefore, radiofrequency ablation of renal artery has become an effective method to remove the sympathetic nerve of renal artery. At present, a single-stage renal artery radiofrequency ablation catheter has appeared to perform renal artery radiofrequency ablation. The head of the single-stage renal artery radiofrequency ablation catheter has a single electrode, which can ablate the sympathetic nerve of the renal artery at a single point. Since one operation can only ablate one point, the work efficiency is low.

In addition, the regulation of renal nerves has been shown to have certain effects 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 decreased removal of water and sodium from the body and increased secretion of renin. Increased renin secretion causes renal vasoconstriction, causing a decrease in renal blood flow. Thus, the renal response to heart failure can prolong the downward spiral of heart failure conditions.

Although related documents or patents have reported related devices for regulating the sympathetic nerve of the renal artery, the existing devices have defects such as inconvenient operation, high manufacturing cost or low efficiency.

In view of this, the utility model provides a renal artery radiofrequency ablation catheter.

Utility model content

In view of the above-mentioned defects of the prior art, the technical problem to be solved by the utility model is to provide a renal artery radiofrequency ablation catheter with convenient operation.

In order to achieve the above purpose, the utility model provides a renal artery radiofrequency ablation catheter, which includes an adjustment assembly for adjusting nerves, and is characterized in that the adjustment assembly includes electrodes and a bearing part for carrying the electrodes. An electrode is used to transmit modulating energy to the nerve, the electrode includes an electrode wire wound on the bearing member, the bearing member has a first shape and a second shape, in the first shape, the The modulation assembly is configured to move within the blood vessel; in the second shape, the electrodes are in a position suitable for delivering the modulation energy to the nerve.

Further, the electrodes extend on the carrying part, so that the electrodes have a fourth shape and a fifth shape, the fourth shape of the electrodes is adapted to the first shape of the carrying part, and the electrodes have The fifth shape is adapted to the second shape of the carrier part.

Further, the electrode is made by tightly winding the electrode wire on the bearing part by a winding machine or by hand.

Further, the diameter of the electrode wire is 0.05-0.25 mm. Further, the two ends of the electrode wire are bonded to the carrying part by using glue, so that the electrode wire is fixed on the carrying part.

Further, the glue is UV curing glue or epoxy resin glue or other adhesives.

Further, the electrode wire is fixed on the bearing part by heat-shrinking the insulation layer at both ends of the electrode wire. Further, the electrode wire is made of platinum-iridium alloy or gold.

Further, the electrode is a continuous electrode formed by tightly winding the electrode wire.

Further, the distance between two adjacent coils of electrode wires is 0-0.5 mm, and the length of the continuous electrodes extending on the bearing part is 10-45 mm.

Further, the continuous electrodes are welded with 1 to 8 sets of wires.

Further, the electrodes are grouped electrodes wound by the electrode wires into multiple groups, and the electrode wires in each group of electrodes are tightly wound.

Further, in each group of electrodes, the distance between two adjacent circles of electrode wires is 0-0.5 mm; the distance between two adjacent groups of electrodes is 1-15 mm, and the length of each group of electrodes extending on the bearing part is 2 mm. ~5mm.

Further, each group of electrodes is welded with a group of wires.

Further, the electrodes are welded with one or more groups of wires, and the wires are used to transmit and adjust energy and feedback temperature and impedance.

Further, the electrodes are welded together with the wires by soldering, and the welding points are covered by an insulating layer.

Further, the electrodes are welded together with the wires through gold or silver, and the welding points are exposed or covered by an insulating layer.

Further, the carrying part includes a first part and a second part, the second part covers the first part, and the wire is arranged inside the second part and passes through the outermost layer of the second part. out soldering with the electrodes.

Further, the renal artery ablation catheter further includes a delivery part for delivering the adjustment assembly to the position of the nerve, and the distal end of the delivery part is connected to the proximal end of the bearing part.

Further, the proximal end is the end away from the nerve site to be adjusted, and the distal end is the end close to the nerve site to be adjusted.

Further, the conveying component includes a metal tube layer, and a polymer layer is heat-shrunk on the outer surface of the metal tube layer.

Further, the metal tube layer is made of NiTi alloy or stainless steel, and the polymer layer is made of PET, FEP or PTFE.

Further, the renal artery radiofrequency ablation catheter further includes a handle for the user to hold, and the handle is connected to the proximal end of the delivery component.

Further, the handle is integrated with the connecting cable of the external energy generator.

Further, the wire extends inside the second part of the bearing part and inside the polymer layer of the delivery part and is installed in the handle.

Further, the energy generated by the external energy generator is one or more of radio frequency energy, heat energy, electromagnetic energy, ultrasonic energy, microwave energy and light energy.

Further, a control line is also provided in the second part, and the control line has a preformed helical structure, so that the bearing part has a preformed helical structure.

Further, the control wire is made of metal or polymer material, and the metal includes NiTi or stainless steel.

Further, the diameter of the control wire is between 0.10mm and 0.50mm.

Further, the outer wall of the control wire has an insulating layer formed by heat shrinkage, and the insulating layer is PTFE or FEP.

Further, the material of the first part is NiTi alloy.

Further, the surface of the first part has a cutting pattern, and the cutting pattern facilitates switching of the bearing member between the first shape and the second shape.

Further, the cutting pattern is a linear groove or a plurality of cylindrical grooves formed by cutting on the surface of the first part according to a cutting angle.

Further, the cutting angle is between 30° and 80°.

Further, the cutting angles of the linear grooves on the surface of the bearing part are the same.

Further, the cutting angles of the linear grooves on the surface of the bearing member are different, and the cutting angles of the linear grooves at the far end of the bearing member are larger than the cutting angles at the proximal end of the bearing member.

Further, the cutting intervals between adjacent cylindrical grooves are the same.

Further, the material of the second part is TPU or Pebax.

Further, the outer diameter of the delivery member is 0.6-1.2 mm.

Further, the outer diameter of the bearing part is 0.9-1.45mm.

Further, the first shape is straight or approximately straight, and the second shape is spiral or approximately spiral.

Further, the diameter of the spiral is 4-14 mm.

Further, the length of the bearing part is 40-140 mm.

In a preferred embodiment of the present utility model, a renal artery radiofrequency ablation catheter is provided, including an adjustment assembly for adjusting a nerve and a delivery part for delivering the adjustment assembly to the position of the nerve, Wherein, the adjustment assembly includes an electrode and a bearing part for bearing the electrode, the electrode is used for transmitting adjustment energy to the nerve, the electrode includes an electrode wire wound on the bearing part, the The carrying member has a first shape in which the adjustment assembly is configured to move in a blood vessel and a second shape in which the electrodes are in a position suitable for delivering the adjustment energy delivery to the location of the nerve; the renal artery ablation catheter further includes a sheath over the delivery member, the sheath enabling the bearing member to be in the first shape and the second shape Switch between two shapes.

Further, the sheath can slide along the delivery part under the control of the control mechanism, and when the sheath is controlled to slide along the delivery part until it is overlaid on the adjustment assembly, the bearing part is held by the first When the second shape is switched to the first shape, and then the sheath tube is controlled to slide along the delivery part to disengage from the adjustment assembly, the bearing part is switched from the first shape to the second shape.

Further, the renal artery ablation catheter further includes a handle for the user to hold, the handle is connected to the proximal end of the delivery component, and the control mechanism is mounted on the handle.

Further, the inner diameter of the sheath is 1.0-1.45 mm, and the outer diameter is 1.25-1.60 mm.

Further, the outer diameter of the bearing part is 0.9-1.45 mm, and the outer diameter of the conveying part is 0.7-1.2 mm.

Further, the sheath includes an inner layer and an outer layer.

Further, the material of the inner layer is PTFE, and the wall thickness is 0.015-0.5 mm.

Further, the outer layer is Pebax or TPU containing 20-40wt% BaSO ₄ .

Further, a braided mesh tube is arranged in the outer layer, and the braided mesh tube includes a first braided wire segment, a second braided wire segment and a third braided wire segment.

Further, the hardness of the first braided wire segment is 25±15D or 50A-90A, the hardness of the second braided wire segment is 40±15D, and the hardness of the third braided wire segment is 72±15D.

Further, the braided wires of the first braided wire segment, the second braided wire segment and the third braided wire segment are stainless steel wires or Ni-Ti wires.

In another preferred embodiment of the present utility model, a renal artery radiofrequency ablation catheter is provided, including an adjustment assembly for adjusting a nerve and a delivery part for delivering the adjustment assembly to the position of the nerve, Wherein, the adjustment assembly includes an electrode and a bearing part for bearing the electrode, the electrode is used for transmitting adjustment energy to the nerve, the electrode includes an electrode wire wound on the bearing part, the The carrying member has a first shape in which the adjustment assembly is configured to move in a blood vessel and a second shape in which the electrodes are in a position suitable for delivering the adjustment energy The location of transmission to the nerve; both the inside of the bearing part and the inside of the delivery part have a guide wire channel, and the guide wire channel inside the bearing part and the guide wire channel inside the delivery part are integrated, The guide wire channel facilitates movement of a guide wire that enables switching of the carrier member between the first shape and the second shape.

Further, the distal end of the bearing part has a hole through which the guide wire can enter the guide wire channel; the delivery part is provided with an opening, and the opening communicates with the guide wire channel, The opening is used for the guide wire to pass through the guide wire channel.

Further, the distal end of the carrying part is provided with a protective part for reducing or avoiding damage to the vessel wall.

Further, the protective component is a soft head, and the material of the soft head is silicone, rubber or thermoplastic elastomer.

Further, the protective component has the hole in the middle.

Further, when the guide wire is inserted into the guide wire channel of the bearing member from the hole at the distal end of the bearing member, the bearing member switches from the second shape to the first shape. Shape; when the guiding wire passes through the opening on the delivery part and is pulled away from the carrying part, the carrying part is switched from the first shape to the second shape.

The renal artery radiofrequency ablation catheter provided by the utility model has the following advantages:

(1) The electrodes are continuous electrodes formed by tightly winding electrode wires or grouped electrodes divided into multiple groups. Compared with other forms of electrodes, longer and more continuous electrodes can be arranged on the carrier part, while The helical bend of the carrier part is not affected. In addition, compared with the prior art, the length of the electrode is longer, which makes the renal artery radiofrequency ablation catheter of the present invention have a better ablation effect.

(2) No special shape control parts are needed, and the shape of the guide wire or the sheath bearing part is used, so the structure is simple and the manufacturing cost is low.

(3) Cutting the surface of the carrying part is convenient for changing the shape of the carrying part.

The conception, specific structure and technical effects of the present utility model will be further described below in conjunction with the accompanying drawings, so as to fully understand the purpose, characteristics and effects of the present utility model.

Description of drawings

Figure 1 is a schematic diagram of the structure of a human kidney;

Fig. 2 is the schematic diagram of the structure of human renal artery;

Fig. 3 is a schematic structural view of the renal artery radiofrequency ablation catheter of the sheath type continuous electrode of the present invention;

Figure 4 is a partial enlarged view of Figure 3;

Fig. 5 is a schematic diagram of a linear groove with the same cutting angle on the surface of the first part of the carrying part, in which the carrying part is in the first shape;

Fig. 6 is a schematic diagram of a linear groove with different cutting angles on the surface of the first part of the carrying part, in which the carrying part is in a first shape;

Fig. 7 is another schematic diagram of a linear groove with different cutting angles on the surface of the first part of the carrying part, in which the carrying part is in the first shape;

Fig. 8 is a schematic diagram of a plurality of cylindrical grooves in the surface of the first part of the bearing member, in which the bearing member is in a first shape;

Fig. 9 is a structural schematic diagram of the renal artery radiofrequency ablation catheter of the sheath-type grouped electrode of the present invention, in which the bearing part is in the second shape;

Fig. 10 is a structural schematic diagram of the renal artery radiofrequency ablation catheter for rapid exchange of mouth-shaped continuous electrodes of the present invention, in which the bearing part is in the second shape;

Fig. 11 is a structural schematic diagram of a renal artery radiofrequency ablation catheter for rapidly exchanging mouth-shaped grouping electrodes of the present invention, in which the bearing part is in the second shape.

detailed description

In the utility model, the abbreviation used:

PTFE refers to polytetrafluoroethylene, namely Polytetrafluoroethylene;

FEP refers to fluorinated ethylene propylene copolymer, namely Fluorinatedethylenepropylene;

TPU refers to thermoplastic polyurethane elastomer rubber, namely Thermoplastic polyurethanes;

PET refers to polyethylene terephthalate, namely Polyethyleneterephthalate;

Pebax refers to polyether block amide, namely Polyetherblockamide

For ease of description, the end of the device or component that is close to the user (or handle) or away from the nerve site that needs to be adjusted is called "proximal end" in the present invention, and the end of the device or component that is far away from the user (or handle) or The end closer to the neural site that needs to be modulated is called the "distal end".

The nerve in the utility model refers to the renal sympathetic nerve located on the human renal artery;

Modulating nerves refers to removing or reducing the activation of said nerves by means of injury or non-injury;

Energy refers to one or more of radio frequency, heat, cooling, electromagnetic energy, ultrasonic, microwave or light energy;

Blood vessel means a human renal artery;

Being suitable for moving in blood vessels means that when the adjustment component moves in the blood vessel, the adjustment component does not damage the blood vessel wall; the largest dimension of the adjustment component in the radial direction of the blood vessel is not greater than the inner diameter of the blood vessel; when the adjustment component moves in the blood vessel, it is easy to pass through the curved section of the blood vessel ;

The location where the modulation energy is delivered to the renal nerve means that when the adjustment component is in the blood vessel, at least one electrode is in a position to contact the wall of the blood vessel.

Figure 1 and Figure 2 show the structure of human kidney and human renal artery.

As shown in Figure 1, the human kidney anatomically includes the kidney 1, the renal artery 2 is connected to the heart via the aorta in the abdomen, and oxygenated blood is supplied to the kidney 1 through the renal artery 2; deoxygenated blood is supplied to the kidney 1 via the renal vein 3 and the inferior cavity Vein 4 runs from kidney 1 to the heart.

As shown in FIG. 2 , the renal nerve 21 extends along the axial direction of the renal artery 2 , and the renal nerve 21 is generally in the adventitia of the renal artery 2 .

The renal artery radiofrequency ablation catheter of the embodiment of the present utility model is used for regulating the renal nerve 21 located on the renal artery 2 , and the regulation refers to removing or reducing the activation of the renal nerve 21 through damage or non-damage. If it is necessary to regulate the nerves of other parts (for example, heart-related nerves), or other regulation methods are required (for example, the activation of nerves needs to be improved), those skilled in the art can make reasonable expectations according to the utility model and do not need to put into practice Adjustment of creative labor.

As shown in Figures 3-4, an embodiment of the present invention provides a renal artery radiofrequency ablation catheter, to be precise, a sheath-type continuous electrode renal artery radiofrequency ablation catheter, the structure of which includes an adjustment component and The delivery part 61, the adjustment assembly includes a bearing part 62 for carrying the electrode 5 and the electrode 5 for transferring adjustment energy to the nerve, the delivery part 61 is used for delivering the adjustment assembly to the position of the nerve. The distal end of the delivery part 61 is connected to the proximal end of the carrying part 62 . The conveying part 61 and the carrying part 62 can be integrated or separated. The shape of the conveying member 61 is one of elongated shape, strip shape, filament shape or fiber shape, and the outer diameter is 0.7-1.2mm. The conveying part 61 includes a metal tube layer, and a polymer layer is heat-shrinked on the outer surface of the metal tube layer, wherein the metal tube layer is made of NiTi alloy or stainless steel, and the material of the polymer layer is PET, FEP or PTFE. The length of the carrying part 62 is 40-140 mm, and the outer diameter is 0.9-1.45 mm. The carrying part includes a first part and a second part. The second part covers the first part. The material of the first part is NiTi alloy. The material is TPU or Pebax.

The carrying part 62 has a first shape and a second shape. In the first shape, the adjustment assembly is suitable for moving in the blood vessel; in the second shape, the adjustment assembly transmits adjustment energy to the position of the nerve through the electrode 5 .

In this embodiment, the electrode 5 is a continuous electrode formed by tightly winding the electrode wire, which is specifically made by tightly winding the electrode wire on the bearing part through a winding machine or by hand. The diameter of the electrode wire is 0.05-0.25 mm, and in this embodiment, the diameter of the electrode wire is set to 0.10 mm. The material of the electrode wire can be metal or metal alloy with better biocompatibility or stability, such as platinum group metal, gold, etc., and the electrode in this embodiment is made of platinum-iridium alloy.

The electrode 5 extends on the carrying part 62 to have a fourth shape and a fifth shape, the fourth shape of the electrode 5 is compatible with the first shape of the carrying part 62, and the fifth shape of the electrode 5 is compatible with the second shape of the carrying part 62. Adaptation, that is, the shape of the carrying member 62 will not be affected by the fact that the electrode wire is wound on the carrying member 62 to form the electrode 5 .

In order to securely install the electrode 5 on the bearing part 62 and minimize damage to the blood vessel wall, the two ends of the electrode wire can be bonded to the bearing part 62 with glue so that the electrode wire can be fixed on the bearing part 62 . The glue can be selected from UV curing glue, epoxy resin glue or its mixture or other adhesives, which not only has biocompatibility for medical use, but also has certain adhesion to metal alloys and polymer materials. It is also possible to bond the two ends of the wire electrode to the bearing part by heat-shrinking the insulation layer, so as to fix the wire electrode on the bearing part 62 . The length of the continuous electrodes extending on the bearing part 62 is 10-45 mm, and the distance between two adjacent coils of electrode wires is 0-0.5 mm.

The electrodes 5 in this embodiment are welded with 1 to 8 groups of wires, the wires are arranged inside the second part of the bearing part 62 and pass through the outermost layer of the second part to be welded with the electrodes 5, and the wires are used for transmission adjustment Energy and feedback temperature, impedance and other parameters. The electrode wire can be welded together with the wire by soldering tin, and at this time, the welding point is covered by an insulating layer. In other embodiments, the electrode wire can also be welded together with the wire through gold or silver, and at this time, the welding point can be exposed or covered by an insulating layer.

The renal artery radiofrequency ablation catheter with a sheath-type continuous electrode in this embodiment also includes a handle for the user to hold, and the handle 8 is connected to the delivery component 61 . The wires extend inside the second part of the carrying part 62 and inside the polymer layer of the delivery part 61 and are mounted in the handle 8 . The handle 8 is integrated with the connecting cable of the external energy generator, so the 1-8 groups of wires in this embodiment are also connected to the external energy generating equipment such as a radio frequency instrument. The energy generated by the external energy generator is one or more of radio frequency energy, heat energy, electromagnetic energy, ultrasonic energy, microwave energy and light energy.

When the electrode 5 is close to the nerve site that needs to be adjusted, the electrode 5 releases a certain amount of energy and acts on the nerve site, thereby regulating the nerve site (for example, reducing or eliminating the activation of the sympathetic nerve).

Electrode 5 can do this by delivering heat to the neural site. For example, heat transfer heating mechanisms for neuromodulation can include thermal ablation and non-ablative thermal alteration or injury, e.g., the temperature of target nerve fibers can be raised above a desired threshold to achieve non-ablative thermal alteration, or beyond High temperature to achieve thermal change of ablation. For example, the target temperature can be at about 37°C-45°C (thermal shift temperature for athermal ablation), or the target temperature can be at about 45°C or higher for ablation thermal shift.

Electrode 5 may also do this by delivering cooling to the neural site. For example, the temperature of the target nerve fibers is lowered below about 20°C to achieve non-cryothermal alteration, or the temperature of the target nerve fibers is lowered to below about 0°C to achieve cryothermal alteration.

The electrodes 5 can also be achieved by applying an energy field to the target nerve fibers. The energy field may include: electromagnetic energy, radio frequency, ultrasonic (including high-intensity focused ultrasonic), microwave, light energy (including laser, infrared and near infrared), etc. For example, heat-induced neuromodulation can be achieved by delivering pulsed or continuous fields of thermal energy to targeted nerve fibers. Among them, a preferred energy method is pulsed radio frequency electric field or other types of pulsed heat energy. Pulsed radiofrequency electric fields or other types of pulsed thermal energy can result in greater heat levels, longer overall duration, and/or better controlled intravascular renal neuromodulation therapy.

No matter what energy method is used to achieve the purpose of regulating nerves, when the user uses the renal artery radiofrequency ablation catheter in this embodiment to work, the electrode 5 needs to be in contact with the device that generates the energy (such as a radio frequency instrument) or the electrode 5 itself generates the energy. The device is electrically connected. These equipments and the connection of electrode 5 and these equipments are the prior art well known to those skilled in the art (for example, the interface that is used to connect these equipments is set in the utility model device, can realize plug and play when using), here Not described in detail.

In this embodiment, the electrodes 5 are approached to the site of the renal nerve that needs to be adjusted in the following ways: entering the human body through blood vessels, and approaching the site of the nerve through the inner wall of the renal artery. Therefore, the technical problem to be solved is: not only to realize that the electrode 5 can closely adhere to the inner wall of the blood vessel to act on the nerve at the corresponding position, but also need the electrode 5 to move conveniently in the blood vessel without damaging the blood vessel wall.

In this embodiment, the second part of the carrying part 62 is also provided with a control line, which has a preformed helical structure, so that the carrying part has a preformed helical structure. The control line is made of metal, such as NiTi or stainless steel. In other embodiments, it can also be made of polymer materials. The diameter of the control wire is between 0.10mm and 0.50mm. The outer wall of the control wire has an insulating layer formed by heat shrinkage, and the insulating layer is PTFE or FEP.

The first shape of the carrying part 62 is straight or approximately straight; the second shape of the carrying part 62 is spiral or approximately spiral; when the carrying part 62 is in the first shape, the carrying part 62 carries the electrode 5 and moves in the blood vessel ; When the bearing member 62 is in the second shape, the electrode 5 is in a position suitable for transmitting the regulating energy to the renal nerve.

In this embodiment, the first shape of the bearing member 62 is straight or nearly straight, and can also be elongated or fibrous or filamentous. The cross section of the straight shape is preferably circular or nearly circular, and the cross section The widest point is less than the inner diameter of the vessel. In this way, in the first shape, when the adjustment assembly moves in the blood vessel, the adjustment assembly will not damage the vessel wall. When the nerve on the renal artery needs to be adjusted, since the inner diameter of the human renal artery is generally 4-7 mm, the maximum size of the adjustment component in the radial direction of the renal artery is not greater than 4 mm, preferably 1-2 mm. It can meet the needs of convenient movement in the blood vessel, has sufficient rigidity and is easy to manufacture, and can reduce the size of the patient's wound. As a variation of this specific embodiment, the first shape can also allow certain bending or wavy bending, and its cross-section can also be other shapes, as long as its surface is smooth, it can be easily moved in the blood vessel without damaging the blood vessel wall. Can.

In this embodiment, the second shape of the carrying part 62 is helical as a whole. In the radial direction of the blood vessel, the widest part of the carrying part is larger than the first shape, so that the carried electrode 5 can approach or contact the blood vessel wall, thereby approaching renal nerves.

Considering that blood vessels have a certain degree of elasticity, the diameter of the helical shape of the bearing member 62 is set at 4-14 mm. For individuals with a smaller inner diameter of the renal artery, for example, the inner diameter is about 4 mm, the helical diameter of the bearing member 62 can be set to about 5-6 mm; for individuals with a larger inner diameter of the renal artery, for example, the inner diameter is about 7 mm, the helical The diameter is set to about 8 ~ 9mm.

The second shape of the bearing part 62 can also be other shapes, such as a smooth curved irregular shape, as long as the electrode is in the position of contacting the blood vessel wall when the bearing part is in the blood vessel.

In this embodiment, in order to facilitate changing the shape of the bearing component 62 , the surface of the first part of the bearing component 62 is cut. As shown in FIGS. 5 to 8 , on the surface of the first part of the bearing component 62 , cutting is performed from the distal end of the bearing component 62 to the proximal end of the bearing component 62 according to the cutting angle. For example, according to the cutting angle, a straight line is cut from the far end of the bearing part 62 to the near end of the bearing part 62 to form a straight line groove; groove.

Place the bearing part 62 horizontally. If it is a straight line groove, the cutting angle is the angle α between the straight line and the horizontal direction; Angle α.

As shown in Figure 5, in another preferred embodiment of the present utility model, the linear groove starts from the far end of the bearing part 62 to the near end of the bearing part 62 at a cutting angle of α=53°, and is continuous according to a straight line cut to form. Wherein, the cutting width of the straight groove is between 0.2449mm-0.6566mm, and the cutting angle of the straight groove shown in FIG. 5 on the first part of the bearing part 62 is always consistent.

As shown in Figure 6, in another embodiment of the present utility model, the linear groove includes two parts: one part is formed by continuous cutting in a straight line starting from the far end of the bearing part 62 at a cutting angle of α=53°; The other part is formed by gradually reducing the cutting angle (α') when approaching the proximal end of the bearing part 62 , and cutting continuously in a straight line according to the gradually decreasing cutting angle (α') until the proximal end of the bearing part 62 .

As shown in Fig. 7, in another embodiment of the present utility model, the linear groove includes two parts: one part is formed by cutting at a cutting angle of α=53°, starting from the far end of the bearing part 62, according to linear intervals; The other part is formed by gradually reducing the cutting angle (α') when approaching the proximal end of the bearing member, and cutting at linear intervals according to the gradually decreasing cutting angle (α') until the proximal end of the bearing member 62 . The cutting width of the linear groove is between 0.2449mm and 0.6566mm.

As shown in Fig. 8, in another preferred embodiment of the present utility model, on the carrier part 62, a plurality of cylindrical grooves are cut at a cutting angle of α=30°, according to a cutting interval of 0.7150mm (two adjacent The horizontal interval between the centers of the cylindrical grooves) is formed by cutting a plurality of cylindrical shapes from the distal end to the proximal end of the bearing member. The angle between each cylindrical groove and the horizontal positive direction is 120°.

In this embodiment, the electrode 5 is a continuous electrode, and compared with other forms of electrodes, the length of the continuous electrode extending on the bearing member 62 is longer. Generally speaking, when performing renal nerve ablation surgery, 3-8 sites of renal nerves need to be ablated. However, the electrode 5 in this embodiment is connected to multiple groups (such as 1 to 8 groups) of wires. On the one hand, when welding multiple groups of wires, the energy transfer is more uniform, and the monitoring of temperature and impedance is more accurate; on the other hand, because the electrode 5 is Continuous electrodes, whereby the electrodes in electrode 5 release energy simultaneously. In this way, when the ablation operation is performed using the catheter device in this embodiment, the ablation operation can be completed only by positioning the adjustment assembly once, and has a good ablation effect.

Elements for measuring temperature, such as thermocouples, may also be arranged on the bearing part 62 .

The distal end of the carrying part 62 is provided with a protective part 10 for reducing or avoiding damage to the blood vessel wall. One function of the protection part 10 is to reduce or avoid damage to the blood vessel wall. When touching the blood vessel wall, it is soft enough and can rebound quickly , will not cause damage to the blood vessel; another function of the protection component 10 is to guide the entire renal artery radiofrequency ablation catheter. The whole catheter device smoothly passes through the bend of the blood vessel.

The protective component 10 is a relatively soft component, which may be a component made of a relatively soft polymer material. In this embodiment, the protective component 10 is a soft head, as shown in FIG. ; The soft head is made of elastic material, such as rubber, silica gel or thermoplastic elastomer; the length of the soft head is 3-15 mm, and the maximum diameter is less than 1.33 mm.

In other embodiments, the protection component 10 can also be a spring, which is arranged at the far end of the bearing component. The spring is made of Ni-Ti alloy or stainless steel, and the pitch is tightly helical, which can meet the elasticity requirement. The length of the spring is 25-50 mm, the outer diameter of the spiral is 0.25-0.6 mm, and the diameter of the spring wire is 0.045-0.12 mm.

In this embodiment, as shown in FIGS. 3 to 4 , the renal artery radiofrequency ablation catheter with a sheath-type continuous electrode further includes a sheath tube 7 , and the sheath tube 7 is overlaid on the delivery part 61 for adjusting the shape of the bearing part 62 . The tube 7 is slidable along the delivery member 61 under the control of a control mechanism 81 mounted on the handle 8, whereby the sheath 7 enables the carrier member 62 to switch between the first shape and the second shape. Specifically, when the control sheath tube 7 slides along the delivery part 61 to be overlaid on the adjustment assembly, because the hardness of the material at the distal end of the sheath tube 7 is greater than that of the bearing part 62, the bearing part 62 changes from the second shape (helical shape) of the initial state. or approximately spiral) is switched to the first shape (straight or nearly straight), and then when the control sheath 7 slides along the delivery part 61 to disengage from the adjustment assembly, due to the elastic force of the bearing part 62 itself, the bearing part 62 is moved by The first shape returns to the second shape. Switching of the carrier part 62 between the first shape and the second shape is thus achieved. In addition, the distal end or distal attachment of the sheath tube 7 can also be provided with a marking part for displaying the sheath tube under X-ray, so as to prevent the sheath tube 7 from protruding too much out of the bearing part 62 during the operation and damaging the kidney tissue .

The inner diameter of the sheath tube 7 is 1.0-1.45 mm, and the outer diameter is 1.25-1.60 mm. The sheath tube 7 includes an inner layer and an outer layer. The thickness of the inner layer is 0.015-0.5 mm. The material of the inner layer is PTFE with a small friction coefficient. When the sheath tube 7 slides relative to the bearing part 62, it can play a smooth role. The material of the outer layer is Pebax or TPU, which may contain 20-40wt% BaSO ₄ .

A braided mesh tube may be arranged in the outer layer of the sheath tube 7, including a first braided wire segment, a second braided wire segment and a third braided wire segment. The hardness of the first braided wire segment is 25±15D or 50A-90A, the hardness of the second braided wire segment is 40±15D, and the hardness of the third braided wire segment is 72±15D. The braided wires of the first braided wire segment, the second braided wire segment and the third braided wire segment are stainless steel wires or Ni-Ti wires. The different hardnesses of the first braided wire segment, the second braided wire segment and the third braided wire segment can be achieved by the same weaving method and the hardness of different outer layer materials (such as Pebax), or by the same outer layer material ( Such as Pebax) hardness and different weaving methods to achieve.

Fig. 9 is a structural schematic diagram of the renal artery radiofrequency ablation catheter with sheath-type grouped electrodes of the present invention, which is different from the renal artery radiofrequency ablation catheter with sheath-type continuous electrodes in that the electrodes are wound into multiple groups by electrode wires Group electrodes. The electrode wires in each group of electrodes 11 are tightly wound, the distance between two adjacent turns of electrode wires in each group of electrodes 11 is 0-0.5 mm, the distance between two adjacent groups of electrodes is 1-15 mm, and each group of electrodes 11 is in the The length extended on the carrying member 62 is 2-5 mm. Each group of electrodes 11 in the grouped electrodes is welded to a group of wires. Compared with existing electrodes of other forms, this grouped electrode can also increase the length on the bearing part 62, so it has a better ablation effect. Each group of electrodes may be connected to each other, or not connected to each other but independent of each other. If each group of electrodes is connected to each other, each group of electrodes releases energy at the same time; if each group of electrodes is independent of each other, then one group of electrodes can be independently controlled to release energy independently.

The working process of the renal artery radiofrequency ablation catheter of the sheath-type continuous electrode or the sheath-type grouping electrode in the embodiment of the present utility model is as follows:

(1) First slide the sheath tube 7 along the delivery part 61 to the adjustment assembly, and the bearing part 62 changes from the second shape (spiral or approximately spiral) to the first shape (straight or approximately straight), which is convenient for moving in the blood vessel ;

(2) Move the renal artery radiofrequency ablation catheter to the renal sympathetic nerve on the human renal artery;

(3) Slide the sheath tube 7 to disengage from the bearing part 62, the bearing part 62 changes from the first shape to the second shape, and the electrode 5 on the bearing part 62 is close to the inner wall of the blood vessel and acts on the nerve at the corresponding position, releasing a certain amount of energy thereby Acts to modulate the neural site (e.g., reduces or eliminates activation of the sympathetic nerve);

(4) Slide the sheath tube 7 to the adjustment assembly again, and the bearing part 62 changes from the second shape to the first shape again;

(5) The renal artery radiofrequency ablation catheter is removed from the human body.

In addition to controlling the shape of the bearing member 62 through the sheath tube 7, the shape of the bearing member 62 may also be controlled in other ways. For example, the renal artery radiofrequency ablation catheter for rapidly exchanging mouth-shaped continuous electrodes shown in FIG. 10 , and the renal artery radiofrequency ablation catheter for rapidly exchanging mouth-shaped grouping electrodes shown in FIG. 11 . In its structure, as shown in Fig. 10 and Fig. 11, different from the catheter for renal artery radiofrequency ablation of sheath-type continuous electrodes or sheath-type group electrodes, the inside of the bearing part 62 (specifically, the inside of the bearing part 62 The inside of the first part) and the inside of the delivery part 61 (specifically, the inside of the metal tube layer in the delivery part 61) have a guide wire channel (not shown), the guide wire channel inside the carrying part 62 and the inside of the delivery part 61 The guide wire channel is integrated, the guide wire channel facilitates the movement of the guide wire, and the movement of the guide wire can make the bearing member 62 switch between the first shape and the second shape. The middle of the protective part 10 at the distal end of the bearing part 62 has a hole (not shown) through which the guide wire can enter the guide wire channel. The delivery part 61 is provided with an opening 12 , referred to as a quick exchange port herein, which communicates with the guide wire channel and is used to guide the guide wire to pass through the guide wire channel. Specifically, when the guide wire is inserted into the guide wire channel of the bearing part 62 from the hole at the far end of the bearing part 62, the bearing part 62 is switched from the second shape to the first shape; When the opening 12 passes through and is pulled away from the bearing part 62, the bearing part 62 switches from the first shape to the second shape.

In this embodiment, the material of the guide wire is NiTi alloy.

In the embodiment of the utility model, the working process of the renal artery radiofrequency ablation catheter for rapid exchange of mouth-shaped continuous electrodes or rapid exchange of mouth-shaped group electrodes is as follows:

(1) First guide the guide wire into the predetermined part of the human body, that is, the renal sympathetic nerve on the human renal artery;

(2) Insert the guide wire tail into the guide wire channel of the bearing part 62 through the hole in the middle of the protective part 10 at the front end of the renal artery radiofrequency ablation catheter, and pass through the quick exchange port 12 of the delivery part 61; The wire is inserted into the bearing part, and the bearing part 62 changes from the second shape (spiral or approximately spiral) to the first shape (straight or approximately straight), so as to facilitate movement in the blood vessel;

(3) Move the renal artery radiofrequency ablation catheter to the renal sympathetic nerve on the human renal artery;

(4) The guide wire is pulled away from the bearing part 62, and the bearing part 62 changes from the first shape to the second shape. The electrodes 5 on the bearing part 62 are close to the inner wall of the blood vessel and act on the nerve at the corresponding position, releasing a certain amount of energy thereby Acts to modulate the neural site (e.g., reduces or eliminates activation of the sympathetic nerve);

(5) Push the guide wire into the carrying part 62, and the carrying part 62 changes from the second shape to the first shape again;

(6) Move the renal artery radiofrequency ablation catheter out of the human body.

The preferred specific embodiments of the present utility model have been described in detail above. It should be understood that those skilled in the art can make many modifications and changes according to the concept of the utility model without creative efforts. Therefore, all technical solutions that can be obtained by those skilled in the art based on the concept of the utility model through logical analysis, reasoning or limited experiments on the basis of the prior art should be within the scope of protection defined by the claims .

Claims (54)

1. A renal artery radiofrequency ablation catheter, comprising an adjustment assembly for adjusting nerves, characterized in that, the adjustment assembly includes electrodes and a bearing part for carrying the electrodes, and the electrodes are used to transfer adjustment energy to The nerve, the electrode comprising an electrode wire wound on the carrier member, the carrier member having a first shape and a second shape, in the first shape, the adjustment assembly is configured to be adapted to in the second shape, the electrode is in a position suitable for delivering the modulating energy to the nerve. 2. The renal artery radiofrequency ablation catheter according to claim 1, characterized in that, the electrodes extend on the bearing part, so that the electrodes have a fourth shape and a fifth shape, and the fourth shape of the electrodes Adapted to the first shape of the carrier part, the fifth shape of the electrode is adapted to the second shape of the carrier part. 3. The renal artery radiofrequency ablation catheter according to claim 1, wherein the electrode is made by tightly winding the electrode wire on the bearing part by a winding machine or by hand. 4. The renal artery radiofrequency ablation catheter according to claim 1 or 2, characterized in that the diameter of the electrode wire is 0.05-0.25 mm. 5. The renal artery radiofrequency ablation catheter according to claim 1, characterized in that, the two ends of the electrode wire are bonded to the bearing part by glue, so that the electrode wire is fixed on the bearing part superior. 6 . The catheter for renal artery radiofrequency ablation according to claim 1 , wherein the electrode wire is fixed on the bearing part by heat-shrinking insulating layers at both ends of the electrode wire. 7 . 7. The renal artery radiofrequency ablation catheter according to claim 1, wherein the electrode wire is made of platinum-iridium alloy or gold. 8. The renal artery radiofrequency ablation catheter according to claim 1, wherein the electrode is a continuous electrode formed by tightly winding the electrode wire. 9. The renal artery radiofrequency ablation catheter according to claim 8, wherein the distance between two adjacent coils of electrode wire is 0-0.5 mm, and the length of the continuous electrode extending on the bearing part is 10-45 mm . 10. The catheter for renal artery radiofrequency ablation according to claim 8, wherein the continuous electrodes are welded with 1 to 8 groups of wires. 11. The renal artery radiofrequency ablation catheter according to claim 1, wherein the electrodes are grouped electrodes wound by the electrode wires into multiple groups, and the electrode wires in each group of electrodes are tightly wound. 12. The renal artery radiofrequency ablation catheter according to claim 11, characterized in that, in each group of electrodes, the distance between two adjacent coils of electrode wire is 0-0.5 mm; the distance between two adjacent groups of electrodes is 1-0.5 mm. The length of each group of electrodes extending on the bearing part is 2-5 mm. 13. The renal artery radiofrequency ablation catheter according to claim 11, characterized in that each set of electrodes is welded to a set of wires. 14. The renal artery radiofrequency ablation catheter according to claim 1, wherein the electrodes are welded with one or more groups of wires, and the wires are used to transmit and adjust energy and feedback temperature and impedance. 15. The renal artery radiofrequency ablation catheter according to claim 14, wherein the electrode is welded together with the wire by soldering, and the welding point is covered by an insulating layer. 16. The renal artery radiofrequency ablation catheter according to claim 14, wherein the electrode is welded to the wire through gold or silver, and the welding point is exposed or covered by an insulating layer. 17. The renal artery radiofrequency ablation catheter according to claim 15 or 16, wherein the bearing member comprises a first part and a second part, the second part wraps the first part, and the guide wire is arranged on The inside of the second part passes through the outermost layer of the second part and is welded to the electrode. 18. The renal artery radiofrequency ablation catheter according to claim 17, characterized in that, the renal artery ablation catheter further comprises a delivery part for delivering the adjustment assembly to the position of the nerve, and the delivery part The distal end is connected to the proximal end of the bearing part, the proximal end is the end away from the nerve site to be adjusted, and the distal end is the end close to the nerve site to be adjusted. 19. The catheter for renal artery radiofrequency ablation according to claim 18, wherein the delivery part comprises a metal tube layer, and a polymer layer is heat-shrunk on the outer surface of the metal tube layer. 20. The renal artery radiofrequency ablation catheter according to claim 19, characterized in that, the outer diameter of the delivery part is 0.6-1.2 mm. 21. The renal artery radiofrequency ablation catheter according to claim 19, wherein the metal tube layer is made of NiTi alloy or stainless steel, and the polymer layer is made of PET, FEP or PTFE. 22. The renal artery radiofrequency ablation catheter according to claim 19, characterized in that, the renal artery radiofrequency ablation catheter further comprises a handle for the user to hold, and the handle is connected to the proximal end of the delivery component. 23. The renal artery radiofrequency ablation catheter according to claim 22, characterized in that the handle and the connecting cable of the external energy generator are integrated. 24. The renal artery radiofrequency ablation catheter according to claim 22, characterized in that, the guide wire extends inside the second part of the bearing part and inside the polymer layer of the delivery part and is mounted on inside the handle. 25. The renal artery radiofrequency ablation catheter according to claim 17, characterized in that, a control line is also arranged in the second part, and the control line has a preformed helical structure, so that the bearing part has a preformed Formed spiral structure. 26. The renal artery radiofrequency ablation catheter according to claim 25, wherein the control wire is made of metal or polymer material, and the metal includes NiTi or stainless steel. 27. The renal artery radiofrequency ablation catheter according to claim 25, wherein the diameter of the control wire is between 0.10 mm and 0.50 mm. 28. The renal artery radiofrequency ablation catheter according to claim 25, wherein the outer wall of the control wire has an insulating layer formed by heat shrinkage, and the insulating layer is PTFE or FEP. 29. The renal artery radiofrequency ablation catheter according to claim 17, wherein the material of the first part is NiTi alloy. 30. The renal artery radiofrequency ablation catheter according to claim 17, wherein the surface of the first part has a cutting pattern, and the cutting pattern facilitates the adjustment of the bearing member between the first shape and the second shape. switch between. 31. The catheter for renal artery radiofrequency ablation according to claim 30, wherein the cutting pattern is a linear groove or a plurality of cylindrical grooves formed by cutting on the surface of the first part according to a cutting angle. 32. The renal artery radiofrequency ablation catheter according to claim 31, wherein the cutting angle is between 30° and 80°. 33. The renal artery radiofrequency ablation catheter according to claim 17, wherein the second part is made of TPU or Pebax. 34. The renal artery radiofrequency ablation catheter according to claim 1, characterized in that, the outer diameter of the bearing part is 0.9-1.45 mm. 35. The renal artery radiofrequency ablation catheter according to claim 1, wherein the first shape is straight or approximately straight, and the second shape is helical or approximately helical. 36. The renal artery radiofrequency ablation catheter according to claim 35, characterized in that, the diameter of the spiral shape is 4-14 mm. 37. The renal artery radiofrequency ablation catheter according to claim 1, wherein the length of the bearing part is 40-140 mm. 38. A renal artery radiofrequency ablation catheter, comprising an adjustment assembly for adjusting nerves and a delivery component for delivering the adjustment assembly to the position of the nerve, characterized in that the adjustment assembly includes electrodes and for a carrying member carrying the electrode for delivering modulating energy to the nerve, the electrode comprising an electrode wire wound on the carrying member, the carrying member having a first shape and a second shape, In the first shape, the modulation assembly is configured to move within a blood vessel; in the second shape, the electrodes are in a position suitable for delivering the modulation energy to the nerve; The renal artery ablation catheter further includes a sheath, the sheath is overlaid on the delivery component, and the sheath enables the carrying component to switch between the first shape and the second shape. 39. The renal artery radiofrequency ablation catheter according to claim 38, wherein the sheath can slide along the delivery part under the control of the control mechanism, when the sheath is controlled to slide along the delivery part to When it is overlaid on the adjustment assembly, the bearing part is switched from the second shape to the first shape, and then when the sheath tube is controlled to slide along the delivery part to disengage from the adjustment assembly, the bearing part switch from the first shape to the second shape. 40. The renal artery radiofrequency ablation catheter according to claim 39, characterized in that, the renal artery ablation catheter further comprises a handle for the user to hold, the handle is connected to the proximal end of the delivery component, and the The control mechanism is mounted on the handle. 41. The renal artery radiofrequency ablation catheter according to claim 38, wherein the inner diameter of the sheath is 1.0-1.45 mm, and the outer diameter is 1.25-1.60 mm. 42. The catheter for renal artery radiofrequency ablation according to claim 41, characterized in that, the outer diameter of the bearing part is 0.9-1.45 mm, and the outer diameter of the delivery part is 0.7-1.2 mm. 43. The renal artery radiofrequency ablation catheter according to claim 38, wherein the sheath comprises an inner layer and an outer layer. 44. The renal artery radiofrequency ablation catheter according to claim 43, wherein the material of the inner layer is PTFE, and the wall thickness is 0.015-0.5 mm. 45. The renal artery radiofrequency ablation catheter according to claim 43, wherein the outer layer is Pebax or TPU containing 20-40 wt% BaSO ₄ . 46. The renal artery radiofrequency ablation catheter according to claim 43, wherein a braided mesh tube is arranged in the outer layer, and the braided mesh tube includes a first braided wire segment, a second braided wire segment and a third braided wire part. 47. The renal artery radiofrequency ablation catheter according to claim 46, wherein the hardness of the first braided wire segment is 25±15D or 50A-90A, and the hardness of the second braided wire segment is 40±15D , the hardness of the third braided wire segment is 72±15D. 48. The renal artery radiofrequency ablation catheter according to claim 46, wherein the braided wires of the first braided wire segment, the second braided wire segment and the third braided wire segment are stainless steel wires or Ni-Ti wires. 49. A renal artery radiofrequency ablation catheter, comprising an adjustment assembly for adjusting nerves and a delivery component for delivering the adjustment assembly to the position of the nerve, characterized in that the adjustment assembly includes electrodes and for a carrying member carrying the electrode for delivering modulating energy to the nerve, the electrode comprising an electrode wire wound on the carrying member, the carrying member having a first shape and a second shape, In the first shape, the modulation assembly is configured to move within a blood vessel; in the second shape, the electrodes are in a position suitable for delivering the modulation energy to the nerve; Both the inside of the bearing part and the inside of the delivery part have guide wire channels, the guide wire channels inside the bearing part and the guide wire channels inside the delivery part are integrated, and the guide wire channels are convenient for guiding Movement of the guide wire enables the carrier member to switch between the first shape and the second shape. 50. The renal artery radiofrequency ablation catheter according to claim 49, wherein the distal end of the bearing part has a hole through which the guide wire can enter the guide wire channel; the delivery part An opening is provided on the top, the opening communicates with the guide wire channel, and the opening is used for the guide wire to pass through the guide wire channel. 51. The catheter for renal artery radiofrequency ablation according to claim 50, characterized in that, the distal end of the bearing member is provided with a protection member for reducing or avoiding damage to the vessel wall. 52. The renal artery radiofrequency ablation catheter according to claim 51, wherein the protective component is a soft tip, and the material of the soft tip is silicone, rubber or thermoplastic elastomer. 53. The renal artery radiofrequency ablation catheter according to claim 51, characterized in that, the middle of the protective component has the hole. 54. The renal artery radiofrequency ablation catheter according to claim 50, wherein when the guide wire is inserted into the guide wire channel of the bearing member from the hole at the distal end of the bearing member, The carrying part is switched from the second shape to the first shape; when the guide wire passes through the opening on the delivery part and is pulled away from the carrying part, the carrying part is The first shape switches to the second shape.