CN106852704B

CN106852704B - Renal artery radio frequency ablation catheter

Info

Publication number: CN106852704B
Application number: CN201510902327.2A
Authority: CN
Inventors: 汪立; 秦杰; 盛卫文; 王震; 朱平; 王国辉
Original assignee: SHANGHAI ANTONG MEDICAL TECHNOLOGY CO LTD; Terumo Corp
Current assignee: SHANGHAI ANTONG MEDICAL TECHNOLOGY CO LTD; Terumo Corp
Priority date: 2015-12-08
Filing date: 2015-12-08
Publication date: 2023-11-24
Anticipated expiration: 2035-12-08
Also published as: CN106852704A

Abstract

The invention discloses a renal artery radio frequency ablation catheter, which comprises an electrode for transmitting adjustment energy to nerves and a bearing component for bearing the electrode, wherein the bearing component is of a tubular structure with a cavity and comprises a metal tube layer, the metal tube layer sequentially comprises a first section, a second section, a third section, a fourth section and a fifth section along the direction from the far end to the near end of the bearing component, and each tube wall of the first section to the fourth section is respectively provided with a first group of cutting grooves, a second group of cutting grooves, a third group of cutting grooves and a fourth group of cutting grooves. The spacing between the grooves in the second group of cutting grooves is larger than the spacing between the grooves in the third group of cutting grooves, so that when the bearing part is subjected to the action of extrusion force along the axial direction, the first section is smoothly connected with the third section through the second section; the spacing of the grooves in the fourth set of cutting grooves is greater than the spacing of the grooves in the third set of cutting grooves, such that when the load bearing member is subjected to an axially compressive force, the third section is smoothly connected to the fifth section by the fourth section.

Description

Renal artery radio frequency ablation catheter

Technical Field

The invention relates to electrosurgery, in particular to a renal artery radio frequency ablation catheter.

Background

Refractory hypertension, namely hypertension (sBP is more than or equal to 160 mmHg) which is still difficult to control by using 3 or more medicines (a diuretic is used), is more common in clinic, has a plurality of pathogenic factors, has an undefined pathogenesis, has poor drug treatment effect, and is still not mature enough in diagnosis and treatment technology, thus becoming one of the great difficulties in treating hypertension.

Recent animal and clinical experimental data demonstrate that modulation of renal nerves (e.g., denervation) can significantly and permanently reduce refractory hypertension, such as recently developed renal artery radiofrequency ablation. The renal artery radio frequency ablation is an interventional technology for removing nerves by sending an electrode catheter into a specific part in the renal artery through a blood vessel and releasing radio frequency current to cause local coagulation necrosis of renal artery sympathetic nerves. The radio frequency current has a small damage range and does not cause harm to the body, so that the renal artery radio frequency ablation has become an effective method for removing renal artery sympathetic nerves. Currently, a single level renal artery radiofrequency ablation catheter has emerged to perform renal artery radiofrequency ablation procedures. The head of the single-stage renal artery radiofrequency ablation catheter is provided with a single electrode, and can perform single-point positioning ablation on renal artery sympathetic nerves, and as only one point can be ablated in one operation, the working efficiency is low.

In addition, modulation of renal nerves has been shown to have an effect on a variety of kidney-related diseases, particularly those resulting from 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 removal from the body and an increase in renin secretion. Increased renin secretion results in renal vasoconstriction, causing a decrease in renal blood flow. Thus, the response of the kidneys to heart failure may extend the spiral decline of heart failure conditions.

Although there are reports in the related literature or patents of related devices for modulating renal artery sympathetic nerves, the currently existing devices have drawbacks such as inconvenient operation, high manufacturing cost or low efficiency.

In view of this, the present invention provides a renal artery radiofrequency ablation catheter.

Disclosure of Invention

In view of the above-mentioned drawbacks of the prior art, the present invention is directed to providing a renal artery radiofrequency ablation catheter with convenient operation.

To achieve the above object, the present invention provides a renal artery radiofrequency ablation catheter, including an electrode for delivering modulation energy to a nerve and a bearing member for bearing the electrode, wherein the bearing member has a tubular structure with a cavity, and includes a metal tube layer, and the metal tube layer sequentially includes a first section, a second section, a third section, a fourth section and a fifth section along a direction from a distal end to a proximal end of the bearing member, wherein a tube wall of the first section has a first set of cutting grooves, a tube wall of the second section has a second set of cutting grooves, a tube wall of the third section has a third set of cutting grooves, and a tube wall of the fourth section has a fourth set of cutting grooves; wherein,

The first set of cutting flutes are such that when the carrier member is subjected to an axially directed compressive force, the first section of the metal tube layer remains straight and parallel to the axis of the renal artery radiofrequency ablation catheter;

the third group of cutting grooves enables the third section of the metal pipe layer to be changed from a straight shape to a spiral shape when the bearing component is subjected to the action of extrusion force along the axial direction;

the spacing between the grooves in the second set of cutting grooves is larger than the spacing between the grooves in the third set of cutting grooves, so that when the bearing part is subjected to the action of extrusion force along the axial direction, the first section and the third section of the metal pipe layer are smoothly connected through the second section;

the spacing between the grooves in the fourth set of cutting grooves is greater than the spacing between the grooves in the third set of cutting grooves, so that when the bearing member is subjected to an axial extrusion force, the third section and the fifth section of the metal tube layer are smoothly connected through the fourth section.

Further, when the pressing force in the axial direction is removed, the second section, the third section, and the fourth section return to a straight shape.

In a preferred embodiment of the present invention, the first set of cutting grooves includes a plurality of first cutting grooves, and the plurality of first cutting grooves are parallel to each other.

Further, the distance between two adjacent first cutting grooves is 0.55-0.8 mm.

Further, each of the first cutting grooves extends along a circumference of a wall of the metal pipe layer by a length less than half of a circumference of the metal pipe layer.

Further, the length of the first group of cutting grooves extending along the axial direction of the bearing component at the pipe wall of the metal pipe layer is 4-8mm.

Further, each first cutting groove is provided with two ends with round holes or approximately round holes, and a straight line groove is arranged between the two ends of each first cutting groove.

Further, the diameter of the circular holes at both ends of the first cutting groove is 0.2 to 0.5mm.

Further, the width of the straight line groove in the first cutting groove is 0.1-0.25 mm.

Further, the two ends of each first cutting groove are a first end and a second end respectively, the connecting line of the first ends of each first cutting groove is a straight line, the connecting line of the second ends of each first cutting groove is a straight line, and the connecting line of the first ends of each first cutting groove is parallel to the connecting line of the second ends of each first cutting groove.

Further, the included angle between the connecting line of the first end part of each first cutting groove and the axis of the renal artery radio frequency ablation catheter is 0-5 degrees; the included angle between the connecting line of the second end part of each first cutting groove and the axis of the renal artery radio frequency ablation catheter is 0-5 degrees.

Further, the second group of cutting grooves includes a plurality of second cutting grooves, and the plurality of second cutting grooves are parallel to each other.

Further, the distance between two adjacent second cutting grooves is 0.6-0.9mm.

Further, each of the second cutting grooves extends along a circumference of a wall of the metal pipe layer by a length greater than half of a circumference of the metal pipe layer.

Further, the second set of cutting grooves extends in the axial direction of the bearing component at the wall of the metal pipe layer for a length of 8-12mm.

Further, each second cutting groove is provided with two ends with round holes, and a straight line groove is arranged between the two ends of each second cutting groove.

Further, the diameter of the circular holes at both ends of the second cutting groove is 0.2-0.5mm.

Further, the width of the linear groove in the second cutting groove is 0.1-0.3mm.

Further, the two ends of each second cutting groove are a third end and a fourth end, the connecting line of the third ends of each second cutting groove is a straight line, the connecting line of the fourth ends of each second cutting groove is a straight line, and the connecting line of the third ends of each second cutting groove is parallel to the connecting line of the fourth ends of each second cutting groove.

Further, the included angle between the connecting line of the third end part of each second cutting groove and the axis of the renal artery radio frequency ablation catheter is 0.2-0.8 degrees; the included angle between the connecting line of the fourth end part of each second cutting groove and the axis of the renal artery radio frequency ablation catheter is 0.2-0.8 degrees.

Further, the third group of cutting grooves comprises a plurality of third cutting grooves and a plurality of fourth cutting grooves, the third cutting grooves are parallel to each other, the fourth cutting grooves are parallel to each other, and the third cutting grooves are parallel to the fourth cutting grooves.

Further, the distance between every two adjacent third cutting grooves is 0.4-0.8mm, the distance between every two adjacent fourth cutting grooves is 0.4-0.8mm, and the distance between the third cutting grooves at the near ends of a plurality of third cutting grooves and the distance between the fourth cutting grooves at the far ends of a plurality of fourth cutting grooves is 0.15-0.35mm.

Further, each of the third and fourth cut grooves extends along a circumference of a wall of the metal pipe layer for a length greater than half a circumference of the metal pipe layer.

Further, the length of the third group of cutting grooves extending along the axial direction of the bearing component at the pipe wall of the metal pipe layer is 8-16mm.

Further, a plurality of the third cutting grooves in the third group of cutting grooves extend in the axial direction of the bearing component at the wall of the metal pipe layer by 1.5-4.5mm in length, and a plurality of the fourth cutting grooves in the third group of cutting grooves extend in the axial direction of the bearing component at the wall of the metal pipe layer by 1.5-4.5mm in length.

Further, each third cutting groove is provided with two ends with round holes, and a straight line groove is arranged between the two ends of each third cutting groove; each fourth cutting groove is provided with two ends with round holes, and a straight line groove is arranged between the two ends of each fourth cutting groove.

Further, the diameter of the circular holes at both ends of the third cutting groove is 0.2-0.5mm; the diameter of the circular holes at both ends of the fourth cutting groove is 0.2-0.5mm.

Further, the width of the linear groove in the third cutting groove is 0.1-0.3mm; the width of the straight line groove in the fourth cutting groove is 0.1-0.3mm.

Further, two ends of each third cutting groove are a fifth end and a sixth end respectively, a connecting line of the fifth ends of each third cutting groove is a straight line, a connecting line of the sixth ends of each third cutting groove is a straight line, and the connecting line of the fifth ends of each third cutting groove is parallel to the connecting line of the sixth ends of each third cutting groove.

Further, two ends of each fourth cutting groove are a seventh end and an eighth end respectively, a connecting line of the seventh ends of each fourth cutting groove is a straight line, a connecting line of the eighth ends of each fourth cutting groove is a straight line, and the connecting line of the seventh ends of each fourth cutting groove is parallel to the connecting line of the eighth ends of each fourth cutting groove.

Further, the included angle between the connecting line of the fifth end part of each third cutting groove and the axis of the renal artery radio frequency ablation catheter is 0.2-0.8 degrees; the included angle between the connecting line of the sixth end part of each third cutting groove and the axis of the renal artery radio frequency ablation catheter is 0.2-0.8 degrees.

Further, the included angle between the connecting line of the seventh end part of each fourth cutting groove and the axis of the renal artery radio frequency ablation catheter is 0.2-0.8 degrees; the included angle between the connecting line of the eighth end part of each fourth cutting groove and the axis of the renal artery radio frequency ablation catheter is 0.2-0.8 degrees.

Further, the fourth set of cutting grooves includes a plurality of fifth cutting grooves, and the plurality of fifth cutting grooves are parallel to each other.

Further, the distance between two adjacent fifth cutting grooves is 0.5-1.3mm.

Further, each of the fifth cutting grooves extends along a circumference of the pipe wall of the metal pipe layer by a length greater than half of a circumference of the metal pipe layer.

Further, the length of the fourth group of cutting grooves extending along the axial direction of the bearing component at the pipe wall of the metal pipe layer is 1.5-4.5mm.

Further, each fifth cutting groove is provided with two ends with round holes, and a straight line groove is arranged between the two ends of each fifth cutting groove.

Further, the diameter of the circular holes at both ends of the fifth cutting groove is 0.15-0.45mm.

Further, the width of the straight line groove in the fifth cutting groove is 0.1-0.3mm.

Further, two ends of each fifth cutting groove are a ninth end and a tenth end respectively, a connecting line of the ninth ends of each fifth cutting groove is a straight line, a connecting line of the tenth ends of each fifth cutting groove is a straight line, and the connecting line of the ninth ends of each fifth cutting groove is parallel to the connecting line of the tenth ends of each fifth cutting groove.

Further, the included angle between the connecting line of the ninth end part of each fifth cutting groove and the axis of the renal artery radio frequency ablation catheter is 0.2-0.8 degrees; the included angle between the connecting line of the tenth end part of each fifth cutting groove and the axis of the renal artery radio frequency ablation catheter is 0.2-0.8 degrees.

Further, the distance between the first group of cutting grooves and the second group of cutting grooves is 0.3-0.5mm, the distance between the second group of cutting grooves and the third group of cutting grooves is 0.1-0.4mm, and the distance between the third group of cutting grooves and the fourth group of cutting grooves is 0.1-0.4mm.

In another embodiment of the present invention, the first set of cutting flutes comprises a plurality of first cutting flutes parallel to each other, each of the first cutting flutes having a first end portion and a second end portion opposite the first end portion; the second set of cutting flutes comprising a plurality of mutually parallel second cutting flutes, each having a third end portion and a fourth end portion opposite the third end portion; the third set of cutting flutes including a plurality of mutually parallel third cutting flutes and a plurality of mutually parallel fourth cutting flutes, each third cutting flute having a fifth end portion and a sixth end portion opposite the fifth end portion, each fourth cutting flute having a seventh end portion and an eighth end portion opposite the seventh end portion; the fourth set of cutting flutes includes a plurality of mutually parallel fifth cutting flutes having a ninth end portion and a tenth end portion opposite the ninth end portion.

Further, the distance between the first end and the third end in the direction perpendicular to the axis of the renal artery radio frequency ablation catheter is 0-0.25mm, the distance between the third end and the fifth end in the direction perpendicular to the axis of the renal artery radio frequency ablation catheter is 0.4-0.6mm, the distance between the fifth end and the seventh end in the direction perpendicular to the axis of the renal artery radio frequency ablation catheter is 0.3-0.7mm, and the distance between the seventh end and the ninth end in the direction perpendicular to the axis of the renal artery radio frequency ablation catheter is 0.35-0.65mm.

Further, a distance between the second end and the fourth end in an axial direction perpendicular to the renal artery radio frequency ablation catheter is 1.45-2.5mm, a distance between the fourth end and the sixth end in an axial direction perpendicular to the renal artery radio frequency ablation catheter is 0.35-0.65mm, a distance between the sixth end and the eighth end in an axial direction perpendicular to the renal artery radio frequency ablation catheter is 0.35-0.7mm, and a distance between the eighth end and the tenth end in an axial direction perpendicular to the renal artery radio frequency ablation catheter is 0.45-1.5mm.

In another preferred embodiment of the present invention, the wall of the fifth section of the metal tube layer has a sixth cutting groove, the sixth cutting groove is a spiral groove formed by cutting around the circumference of the metal tube layer, the distance between each circle of spiral groove gradually increases along the direction from the distal end to the proximal end of the fifth section, and the width of the spiral groove is 0.1-0.3mm.

In another preferred embodiment of the present invention, the first set of cutting flutes comprises a plurality of mutually parallel elliptical flutes, each of the elliptical flutes extending less than half the circumference of the metal tube layer along the circumference of the tube wall.

In another preferred embodiment of the present invention, the material of the metal tube layer is NiTi alloy.

Further, the outer wall of the metal tube layer is coated with an insulating layer, and the insulating layer is made of TPU or Pebax.

Further, the renal artery ablation catheter also includes a delivery member for delivering the carrier member and the electrode to a location of the nerve to be modulated.

Further, the distal end of the delivery member is connected to the proximal end of the carrier member, the proximal end being the end distal to the nerve site to be modulated, and the distal end being the end proximal to the nerve site to be modulated.

Further, the conveying component is of a hollow tubular structure, and comprises a metal pipe layer made of NiTi alloy or stainless steel and a polymer layer made of PET, FEP or PTFE sequentially outwards along the radial direction of the tubular structure.

Further, the renal artery radio frequency ablation catheter also includes a handle for grasping by a user, the handle being connected to the proximal end of the delivery member.

Further, the handle is provided integrally with a connection cable of an external energy generator.

Further, the electrodes are welded with wires for transmitting energy and feeding back temperature, impedance.

Further, the electrode is welded with the lead through soldering tin, and the welding point is coated through an insulating layer.

Further, the electrode is welded with the lead through gold or silver, and the welding point is exposed or covered by an insulating layer.

Further, the lead is arranged inside the insulating layer of the bearing component and penetrates out of the outermost layer of the insulating layer of the bearing component to be welded with the electrode; the lead wire extends inside the insulating layer of the bearing part and inside the polymer layer of the conveying part, and is installed in the handle.

Further, a pull wire is disposed in the cavity of the bearing member, and the pull wire can apply an axial extrusion force to the bearing member.

Further, the distal end of the pull wire is fixed to an inner wall at the distal end of the carrying member, and the proximal end of the pull wire is connected to a control member provided in the handle for controlling the tightening or loosening of the pull wire.

Further, applying an axial force to the carrier member by tightening the pull wire, the third section of the metal tube layer being helical when the pull wire is tightened; when the pull wire is released, the third segment returns to a straight shape.

Further, when the third section of the metal pipe layer is in a spiral shape, the spiral diameter of the spiral shape is 4-14 mm, the pitch of the spiral is 3-8 mm, and the number of turns of the spiral shape is 1-2.

Further, the distal end of the pull wire is welded to the inner wall of the carrier member by a resistance welder.

Further, the diameter of the pull wire is 0.1-0.25 mm.

Further, the stay wire is made of NiTi alloy wires or stainless steel wires.

Further, the electrode is manufactured by tightly winding the electrode wire around the carrier member by a winding machine or by hand.

Further, the diameter of the electrode wire is 0.05-0.25 mm.

Further, both ends of the electrode wire are adhered to the bearing part by using glue, so that the electrode wire is fixed on the bearing part.

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

Further, the electrode wire is fixed on the bearing part by thermally shrinking the two ends of the electrode wire to the insulating layers.

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 circles of electrode wires is 0-0.5 mm, and the length of the continuous electrode extending on the bearing part is 10-45 mm.

Further, the continuous electrode is welded with 1 to 8 groups of wires.

Further, the electrodes are grouped electrodes formed by winding the electrode wires into a plurality of groups, and the electrode wires in each group of electrodes are tightly wound.

Further, in each group of electrodes of the grouping electrode, 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 component is 2-5 mm.

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

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

Further, the protection component is made of elastic materials.

Further, the elastic material is rubber, silica gel or thermoplastic elastomer.

Further, the length of the protection component is 3-15mm, and the maximum diameter is less than 1.33mm.

Further, the conveying member is integral with the carrying member.

Further, the outer diameters of the conveying component and the bearing component are 0.55-1.0 mm, and the wall thickness is 0.05-0.15mm.

The renal artery radio frequency ablation catheter provided by the invention has the following advantages:

(1) Through cutting the pipe wall of the metal pipe layer of the bearing component, the cutting grooves are combined grooves formed by multiple groups of grooves, and the multiple groups of grooves enable each section on the bearing component to be in a straight shape, a spiral shape and a straight shape in sequence along the direction from the far end to the near end of the bearing component when the bearing component is subjected to the action of the extrusion force along the axial direction, and the straight shape and the spiral shape are in smooth connection, so that the spiral shape of the bearing component is easy to form, the actually required spiral parameters are easy to achieve, and the appearance is better. The cutting slot at the distal end of the carrier member makes it straight and makes the straight shape keep parallel with the axis of the renal artery radiofrequency ablation catheter, thereby facilitating the adherence of the electrode. In addition, the shape of the bearing component is controlled by using a pull wire which is simple in manufacture, low in cost and convenient to operate, so that the movement of the renal artery radio frequency ablation catheter in the blood vessel or the transmission of energy regulation can be easily realized. The renal artery radio frequency ablation catheter is simpler and more convenient to operate, greatly reduces the workload of medical staff, also strives for precious time for operation, greatly increases the success rate of the operation, and has strong clinical practicability.

(2) The electrode forms a continuous electrode formed by a plurality of electrodes through electrode wires, and compared with other forms of electrodes, the electrode can be provided with longer and more continuous electrodes on the bearing part without influencing the spiral curve shape of the bearing part. In addition, the longer electrode length makes the renal artery radiofrequency ablation catheter of the invention have better ablation effect.

(3) The electrode can adjust a plurality of nerve points simultaneously, so that the working efficiency and the treatment accuracy are improved.

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

Drawings

FIG. 1 is a schematic diagram of the structure of a human kidney;

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

FIG. 3 is a schematic cross-sectional view of the components of one embodiment of a renal artery radio frequency ablation catheter of the present invention;

FIG. 4 is a schematic cross-sectional view of the components of another embodiment of the renal artery radio frequency ablation catheter shown in FIG. 3;

FIG. 5 is a schematic view of a carrier member carrying continuous electrodes in accordance with an embodiment of the present invention;

FIG. 6 is a schematic diagram of a carrier member carrying grouped electrodes according to an embodiment of the present invention;

FIG. 7 is a cross-sectional view of a load bearing member of an embodiment of the invention;

FIG. 8 is a schematic view of a preferred embodiment of a cutting slot in the wall of a metallic tube layer of a carrier member of a renal artery radio frequency ablation catheter of the present invention, wherein the fifth segment of the metallic tube layer is not provided with a cutting slot;

FIG. 9 is a schematic view of another preferred embodiment of a cut groove in the wall of a metal tube layer of a carrier member of a renal artery radio frequency ablation catheter of the present invention, wherein the fifth segment of the metal tube layer is a spiral groove;

fig. 10 is a schematic view of a cutting groove of a wall of a metal tube layer of a carrying member of a renal artery radio frequency ablation catheter of the present invention, wherein a first section of the metal tube layer is a plurality of elliptical grooves.

Detailed Description

In the present invention, abbreviations used:

PTFE refers to Polytetrafluoroethylene, namely Polytetrafluoroethylene;

FEP refers to fluorinated ethylene propylene copolymer, fluorinated ethylene propylene;

PET refers to polyethylene terephthalate, polyethylene terephthalate;

pebax refers to polyether block amide, polyether block amide;

TPU refers to thermoplastic polyurethane elastomer rubber, thermoplastic polyurethanes.

For ease of description, the end of the device or component that is proximal to the user (or handle) or distal to the nerve site to be modulated is referred to herein as the "proximal end" and the end of the device or component that is distal to the user (or handle) or proximal to the nerve site to be modulated is referred to herein as the "distal end".

The nerve in the present invention refers to renal sympathetic nerve located on human renal artery;

modulating a nerve refers to removing or reducing activation of the nerve by means of injury or non-injury;

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

the blood vessel refers to the human renal artery;

adapted to move in a blood vessel means that the regulatory element does not damage the vessel wall when the regulatory element is moved in the blood vessel; the maximum size of the regulating component in the radial direction of the blood vessel is not larger than the inner diameter of the blood vessel; easy passage through the curved segment of the vessel as the adjustment assembly is moved in the vessel;

the delivery of the modulation energy to the location of the renal nerve means that the at least one electrode is in a position to contact the vessel wall when the modulation member is in the vessel.

Fig. 1-7 illustrate a preferred embodiment of a renal artery radiofrequency ablation catheter and method of use provided by the present invention, for example, for modulating human renal nerves.

Fig. 1 and 2 show structures of human kidneys and human renal arteries. As shown in fig. 1, a human kidney anatomically includes a kidney 1, a renal artery 2 connected to the heart via the aorta of the abdomen, and oxygenated blood supplied to the kidney 1 through the renal artery 2; deoxygenated blood flows from the kidney 1 to the heart via the renal vein 3 and the inferior vena cava 4.

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 within the adventitia of the renal artery 2.

In this embodiment, a renal artery radiofrequency ablation catheter is used to modulate renal nerves 21 located on the renal artery 2 by removing or reducing activation of the renal nerves 21 by a damaging or non-damaging means. If there is a need to modulate nerves in other areas (e.g., heart-related nerves) or other ways of modulating (e.g., to increase activation of nerves), those skilled in the art can make adjustments in accordance with the present invention that are reasonably anticipated without the need to carry out inventive efforts.

As shown in fig. 3, a preferred embodiment of the present invention provides a renal artery radiofrequency ablation catheter having a structure including an electrode 5 for delivering modulation energy to a nerve, a carrier member 62 for carrying the electrode 5, a delivery member 61 for delivering the carrier member 62 and the electrode 5 to a location of the nerve to be modulated, and a handle 8. Wherein the distal end of the delivery member 61 is connected to the proximal end of the carrier member 62 and the distal end of the handle 8 is connected to the proximal end of the delivery member 61. The conveying member 61 and the bearing member 62 may be integral or separate, and the outer diameters of the conveying member 61 and the bearing member 62 are 0.55mm to 1.50mm, and the wall thicknesses are 0.05 mm to 0.15mm.

The carrier 62 has a first shape in which the carrier 62 is adapted to move in a blood vessel and a second shape; in the second shape, the electrode 5 is in a position suitable for delivering modulation energy to the nerve.

In this embodiment, as shown in fig. 5, the electrode 5 is a continuous electrode formed by tightly winding a wire electrode, specifically, by tightly winding the wire electrode on the carrier member 62 by a winding machine or by hand. Wherein the diameter of the wire electrode is 0.05-0.25 mm, in this embodiment, the diameter of the wire electrode is set to 0.10mm. The electrode wire can be made of metal or metal alloy with better biocompatibility or relatively stable, such as platinum group metal, gold and the like, and the electrode in the embodiment is made of platinum iridium alloy.

In order to firmly mount the electrode 5 on the carrier member 62 and minimize damage to the vessel wall, glue may be used to adhere both ends of the wire electrode to the carrier member 62 so that the wire electrode is fixed to the carrier member 62. The glue can be UV curing glue, epoxy resin glue or a mixture thereof, so that the glue has biocompatibility which can achieve medical use and has certain binding force on metal alloy and high polymer materials. The wire electrode may also be secured to the carrier member 62 by bonding the ends of the wire electrode to the carrier member by means of a heat shrink insulating layer. The length of the continuous electrode extending on the carrier 62 is 10-45 mm, and the distance between two adjacent turns of the electrode is 0-0.5 mm.

In this embodiment, as shown in fig. 7, the bearing member 62 has a tubular structure with a cavity, and includes a metal tube layer 100, and the material of the metal tube layer 100 is NiTi alloy. The outer wall of the metal tube layer 100 is covered with an insulating layer 101 made of TPU or Pebax. The delivery member 61 is also a hollow tubular structure (not shown here) comprising, in order radially outwards of the tubular structure, a metal tube layer of NiTi alloy or stainless steel material, a polymer layer of PET, FEP or PTFE.

In this embodiment, since the electrode 5 is a continuous electrode, the electrode 5 is soldered to 1 to 8 sets of wires 102 for transmitting the energy for adjustment and the feedback temperature and impedance. The lead 102 is provided inside the insulating layer of the carrier 62, and penetrates from the outermost layer of the insulating layer 101 of the carrier 62 to be soldered to the electrode 5. The wire electrode 51 may be soldered to the wire 102 by solder, where the solder joint is covered by an insulating layer. In other embodiments, the electrode wire 51 may be soldered to the lead 102 by gold or silver, where the soldered point may be exposed or covered by an insulating layer. The lead 102 is provided in the insulating layer 101 of the carrier member 62, extends inside the insulating layer 101 of the carrier member 62 and inside the polymer layer of the conveying member 61, and is mounted in the handle 8. The handle 8 is provided integrally with a connection cable of an external energy generator, so that the 1-8 sets of wires 102 of the present embodiment are also connected to an external energy generating device, 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 approaches a nerve site to be modulated, the electrode 5 releases a certain amount of energy and acts on the nerve site, thereby acting to modulate the nerve site (e.g., reduce or eliminate activation of sympathetic nerves).

The electrode 5 may achieve this by transferring heat to the nerve site. For example, the heat transfer heating mechanism for neuromodulation may include thermal ablation and non-ablative thermal changes or lesions, e.g., the temperature of the target nerve fibers may be raised above a desired threshold to achieve non-ablative thermal changes, or above a higher temperature to achieve ablative thermal changes. For example, the target temperature may be about 37 ℃ -45 ℃ (thermal temperature for non-thermal ablation), or the target temperature may be about 45 ℃ or higher for thermal ablation.

The electrode 5 may also achieve this by delivering cooling to the nerve site. For example, the temperature of the target nerve fiber is reduced to below about 20 ℃ to effect non-frozen heat changes, or the temperature of the target nerve fiber is reduced to below about 0 ℃ to effect frozen heat changes.

The electrode 5 may also be implemented by applying an energy field to the target nerve fiber. The energy field may include: electromagnetic energy, radio frequency, ultrasound (including high intensity focused ultrasound), microwaves, light energy (including laser, infrared, and near infrared), and the like. For example, thermally induced neuromodulation may be achieved by delivering a pulsed or continuous thermal energy field to the target nerve fibers. One preferred energy pattern is a pulsed radio frequency electric field or other type of pulsed thermal energy. Pulsed radio frequency electric fields or other types of pulsed thermal energy may facilitate greater heat levels, longer overall durations, and/or better controlled intravascular renal neuromodulation therapy.

No matter what energy mode is used to achieve the nerve modulation, when the user is working with the renal artery radiofrequency ablation catheter of this embodiment, the electrode 5 needs to be electrically connected to a device that generates the energy (e.g., a radiofrequency meter) or that causes the electrode 5 itself to generate the energy. The connection of these devices and the electrodes 5 to these devices is known to the person skilled in the art (for example, interfaces for connecting these devices are provided in the device according to the invention, plug and play is possible in use) and will not be described in detail here.

In this embodiment, the approach of the electrode 5 to the renal nerve site to be regulated is as follows: enters the human body through the blood vessel and approaches the nerve site through the inner wall of the renal artery. The technical problems to be solved are as follows: the electrode can be tightly attached to the inner wall of the blood vessel to act on the nerve at the corresponding position, and the electrode needs to conveniently move in the blood vessel without damaging the wall of the blood vessel.

The first shape of the carrier 62 is straight or approximately straight; the second shape of the carrier 62 comprises a spiral or near-spiral shape; when the carrier 62 is in the first shape, the carrier 62 carries the electrode 5 for movement in the blood vessel; when the carrier 62 is in the second shape, the electrode 5 is in a position suitable for delivering modulation energy to the renal nerve.

In this embodiment, the first shape of the carrier 62 is straight or nearly straight, but may be elongated or fibrous or filiform, and the straight cross-section is preferably circular or nearly circular, with the widest point of the cross-section being less than the inner diameter of the vessel. Thus, in the first shape, the carrier member 62 does not damage the vessel wall when the carrier member 62 carrying the electrode 5 is moved in the vessel. When it is necessary to regulate the nerve on the renal artery, since the internal diameter of the human renal artery is generally 4 to 7mm, the maximum dimension of the carrier 62 carrying the electrode 5 in the radial direction of the renal artery is not more than 4mm, preferably 1 to 2mm, which can satisfy the convenience of movement in the blood vessel, has sufficient rigidity and is convenient 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 a certain curvature or a wavy curvature, and its cross section may also be other shapes, as long as its surface is smooth, and can be moved easily in the blood vessel without damaging the vessel wall.

In this embodiment, the second shape of the carrier 62 comprises a spiral shape, the widest point of the carrier being larger than the first shape in the radial direction of the vessel, so that the carried electrode 5 is brought into close proximity or contact with the vessel wall and thus the renal nerve.

The diameter of the spiral shape of the bearing member 62 is set to 4 to 14mm in consideration of the elasticity of the blood vessel. For individuals with smaller internal diameters of the renal arteries, for example, an internal diameter of about 4mm, the spiral diameter of the carrier 62 may be set to about 5 to 6 mm; for an individual having a large internal diameter of the renal artery, for example, the internal diameter of the spiral may be set to about 8 to 9 mm.

In this embodiment, the pitch of the helix of the carrier 62 is 3-8 mm, and the number of turns of the helix is 1-2, preferably 1.5.

The second shape of the carrier 62 may also include other approximately spiral shapes, such as an irregular shape with a rounded curve, as long as the electrode is in a position to contact the vessel wall when the carrier is in the vessel.

The second shape of the carrier 62 of the present embodiment also includes a straight or approximately straight shape, that is, when the carrier 62 is in the second shape, the carrier 62 has a straight portion and a spiral portion, and both sides of the spiral portion thereof are straight portions. The straight front end of the spiral shape is used for obtaining better ablation effect and better appearance of the ablation catheter, and the straight rear end of the spiral shape is used for the need of the ablation catheter.

In this embodiment, the electrode 5 is a continuous electrode that extends over a longer length on the carrier 62 than other forms of electrodes. Generally, ablation of 3-8 sites of renal nerves is required when performing renal nerve ablation procedures. The electrode 5 in this embodiment is connected with multiple groups (for example, 1-8 groups) of wires, on one hand, when multiple groups of wires are welded, the energy transfer is more uniform, and the temperature and impedance monitoring is more accurate; on the other hand, since the electrodes 5 are continuous electrodes, the electrodes in the electrodes 5 simultaneously release energy. Therefore, when the catheter device in the embodiment is used for ablation operation, the ablation operation can be completed only by positioning the adjusting assembly once, and the ablation effect is good.

In another embodiment of the invention, as shown in fig. 6, the electrodes 5 are grouped electrodes wound in groups from wire 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 the length of each group of electrodes 11 extending on the bearing part 62 is 2-5 mm. Each group of electrodes 11 of the group of electrodes is soldered to a group of wires. The grouped electrodes also can increase the length on the carrier 62 compared to other existing forms of electrodes, thus providing better ablation. The electrodes of each group may be connected to each other or may be independent of each other without being connected to each other. If the sets of electrodes are interconnected, the sets of electrodes simultaneously release energy. If the sets of electrodes are independent of each other, then individual energy release from one set of electrodes can be controlled individually. The electrode independent control refers to whether one group of electrodes transmits the adjustment energy or not, and the other groups of electrodes are irrelevant, so that a single group of electrodes can be controlled to release energy according to the requirement of an ablation operation.

Elements for measuring temperature, such as thermocouples, may also be provided on the carrier 62.

The distal end of the carrier member 62 is provided with a protective member 10 (see fig. 3 and 4) for reducing or avoiding damage to the vessel wall, one function of the protective member 10 being to reduce or avoid damage to the vessel wall, when touching the vessel wall, because it is soft enough and can rebound rapidly without causing loss to the vessel; another function of the protective member 10 is to guide the entire renal artery radiofrequency ablation catheter, and when encountering a kink of a blood vessel, it is itself able to bend according to the kink of the blood vessel, thereby guiding the entire catheter device smoothly through the kink of the blood vessel.

The protecting component 10 is a relatively soft component, which can be made of a polymer material with relatively soft material, and in this embodiment, the protecting component 10 is a soft head, so as to avoid the damage to the blood vessel by the distal end of the bearing component; the soft head is made of elastic materials, and the elastic materials are rubber, silica gel or thermoplastic elastomer; the length of the soft head is 3-15 mm, and the maximum diameter is less than 1.33mm.

In other embodiments, the protection member 10 may be a spring, which is made of Ni-Ti alloy or stainless steel and has a pitch that is tightly spiral to meet the elastic requirement, and is disposed at the distal end of the carrier member. 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 an embodiment of the invention, a pull wire 70 is disposed within the cavity of the carrier 62 for controlling the shape change of the carrier. (see fig. 3 and 4) the distal end of the pull wire 70 is welded to the inner wall at the distal end of the carrier member 62 by a resistance welder. The pull wire 70 is capable of controlling the carrier member 62 to switch between the first shape and the second shape: when the pull wire 70 is pulled, the bearing member 62 receives a pressing force in the axial direction, and the bearing member 62 is in the second shape; when the pull wire 70 is released, the carrier 62 is in the first shape. The diameter of the pull wire 70 is 0.1-0.25 mm, and a NiTi alloy wire or a stainless steel wire is adopted. The pull wire 70 may also be made of a polymer material, including high molecular weight polyethylene UHMWPE, polyethylene PP, nylon, or polyethanolamine PGA, etc. for making the pull wire.

The proximal end of the pull wire 70 is connected to a control member 81 (see fig. 3), which control member 81 is used for performing a tightening or loosening control operation of the pull wire 70. The control member 81 is disposed on the handle 8, and in particular, is disposed within an elongated slot in the handle 8 along which an operator can push the control member 81 to tighten or loosen the cable 70.

In other embodiments, as shown in fig. 4, the handle 8 includes a first sliding member 82 and a second sliding member 83, the second sliding member 83 is sleeved outside the first sliding member 82, and the first sliding member 82 and the second sliding member 83 are slidable with each other. In this case, the proximal end of the pull wire 70 is fixedly connected to the second sliding member 83. The pull wire 70 controls the shape change of the carrier member 62 as the second sliding member 83 slides along the first sliding member 82.

The working process of the renal artery radiofrequency ablation catheter in the embodiment is as follows:

1. the pull wire 70 is first placed in an undamped condition, i.e., the carrier 62 is in a first (straight) shape;

2. moving the carrier member 62 of the ablation catheter to a renal sympathetic nerve on a human renal artery;

3. placing the pull wire 70 in tension so that the carrier 62 is in the second shape, the electrode 5 on the carrier 62 acts against the inner wall of the blood vessel to release energy from the nerve at the corresponding location to act as a means for modulating the nerve site (e.g., reducing or eliminating activation of sympathetic nerves);

4. placing the pull wire 70 again in the undamped condition with the carrier 62 changing from the second shape to the first shape;

5. the ablation catheter is removed from the body.

In a preferred embodiment of the present invention, the metal tube layer 100 of the carrier 62 includes a first section 210, a second section 220, a third section 230, a fourth section 240 and a fifth section 250 in this order along the distal-to-proximal direction of the carrier 62, and for convenience of controlling the shape change of the carrier 62 using the wire 70, the tube wall of the metal tube layer 100 of the carrier 62 is cut such that the tube wall of the first section 210 of the metal tube layer 100 has a first set of cutting grooves, the tube wall of the second section 220 has a second set of cutting grooves, the tube wall of the third section 230 has a third set of cutting grooves, and the tube wall of the fourth section 240 has a fourth set of cutting grooves. Wherein,

the first set of cut grooves allows the first section 210 of the metal tube layer 100 to remain straight and parallel to the axis of the renal artery radiofrequency ablation catheter when the carrier member 62 is subjected to an axial compressive force, which facilitates the apposition of the electrodes carried on the carrier member 62 and effectively avoids damage to the vessel wall at the distal end of the carrier member 62.

The third set of cut grooves is such that when the carrier 62 is subjected to a compressive force in the axial direction, the third segment 230 of the metal tube layer 100 is changed from a straight shape to a spiral shape having a spiral diameter of 4 to 14mm, a pitch of 3 to 8mm, and a number of turns of 1 to 2.

The spacing of the grooves in the second set of cut grooves is greater than the spacing of the grooves in the third set of cut grooves so that when the load bearing member 62 is subjected to an axially compressive force, the first section 210 of the metal tube layer 100 is smoothly connected to the third section 230 by the second section 220.

The spacing of the grooves in the fourth set of cut grooves is greater than the spacing of the grooves in the third set of cut grooves so that when the load bearing member 62 is subjected to compressive forces in the axial direction, the third segment 230 of the metal tube layer 100 is smoothly connected to the fifth segment 250 by the fourth segment 240.

When the tension wire 70 is pulled to subject the carrier 62 to a compressive force in the axial direction, the carrier 62 is in the second shape as shown in fig. 5 and 6.

When the pressing force in the axial direction is removed, the second, third and fourth sections 220, 230 and 240 return to a straight shape.

As shown in particular in fig. 8. In the figures, the carrier 62 is in a first shape and is disposed horizontally along its length. The first set of cutting flutes includes a plurality of first cutting flutes that are parallel to one another. The spacing between two adjacent first cutting grooves is 0.55-0.8 mm, preferably 0.66mm. Each first cutting groove extends along the circumference of the pipe wall of the metal pipe layer 100 by a length less than half of the circumference of the metal pipe layer 100. The first set of cutting flutes extend in the axial direction of the carrier 62 at the wall of the metal tube layer 100 for a length of 4-8mm, preferably 5.8mm. Each first slot has two ends with a circular or near circular aperture and a straight slot 213 is located between the two ends of each first slot. The diameter of the circular holes at the two ends of the first cutting groove is 0.2-0.5 mm. The width of the straight groove 213 in the first cutting groove is 0.1 to 0.25mm. The two ends of each first cutting groove are a first end 211 and a second end 212 respectively, the connecting line of the first ends 211 of each first cutting groove is a straight line, the connecting line of the second ends 212 of each first cutting groove is a straight line, and the connecting line of the first ends 211 of each first cutting groove is parallel to the connecting line of the second ends 212 of each first cutting groove. The included angle between the connecting line of the first end 211 of each first cutting groove and the axis of the renal artery radiofrequency ablation catheter is 0-5 degrees; the line connecting the second ends 212 of each first cutting slot is at an angle of 0-5 deg. to the axis of the renal artery radio frequency ablation catheter.

The second set of cutting flutes includes a plurality of second cutting flutes, the plurality of second cutting flutes being parallel to one another. The spacing between two adjacent second cutting grooves is 0.6-0.9mm, preferably 0.775mm. Each of the second cutting grooves extends along the circumference of the pipe wall of the metal pipe layer 100 by a length greater than half of the circumference of the metal pipe layer 100. The second set of cut grooves extends in the axial direction of the carrier 62 at the wall of the metal tube layer 100 by a length of 8-12mm, preferably 11mm. Each second cutting slot has two ends with circular holes, and a straight slot 223 is arranged between the two ends of each second cutting slot. The diameter of the circular holes at both ends of the second cutting groove is 0.2-0.5mm. The width of the straight groove 223 in the second cutting groove is 0.1-0.3mm. The two ends of each second cutting groove are a third end 221 and a fourth end 222, respectively, the connection line of the third end 221 of each second cutting groove is a straight line, the connection line of the fourth end 222 of each second cutting groove is a straight line, and the connection line of the third end 221 of each second cutting groove is parallel to the connection line of the fourth end 222 of each second cutting groove. The included angle between the connecting line of the third end 221 of each second cutting groove and the axis of the renal artery radio frequency ablation catheter is 0.2-0.8 degrees; the line connecting the fourth end 222 of each second cutting slot is at an angle of 0.2-0.8 deg. to the axis of the renal artery radio frequency ablation catheter.

The third group of cutting grooves comprises a plurality of third cutting grooves and a plurality of fourth cutting grooves, the plurality of third cutting grooves are parallel to each other, the plurality of fourth cutting grooves are parallel to each other, and the third cutting grooves are parallel to the fourth cutting grooves. The spacing between two adjacent third cutting grooves is 0.4-0.8mm, preferably 0.56mm; the spacing between two adjacent fourth cutting grooves is 0.4-0.8mm, preferably 0.56mm; the distance between the third cutting groove at the proximal end of the third cutting grooves and the fourth cutting groove at the distal end of the fourth cutting grooves is 0.15-0.35mm. Each third and fourth cut groove extends along the circumference of the pipe wall of the metal pipe layer 100 for a length greater than half the circumference of the metal pipe layer 100. The third set of cut grooves extends in the axial direction of the carrier 62 at the wall of the metal tube layer 100 for a length of 8-16mm. The plurality of third cutting grooves of the third group of cutting grooves extend in the axial direction of the carrier 62 at the pipe wall of the metal pipe layer 100 by a length of 1.5 to 4.5mm, preferably 2.28mm, and the plurality of fourth cutting grooves of the third group of cutting grooves extend in the axial direction of the carrier 62 at the pipe wall of the metal pipe layer 100 by a length of 1.5 to 4.5mm, preferably 2.28mm. Each third cutting groove is provided with two ends with round holes, and a straight line groove 233 is arranged between the two ends of each third cutting groove; each fourth slot has two ends with circular holes and a straight slot 236 is located between the two ends of each fourth slot. The diameter of the circular holes at the two ends of the third cutting groove is 0.2-0.5mm; the diameter of the circular holes at both ends of the fourth cutting groove is 0.2-0.5mm. The width of the straight groove 233 in the third cutting groove is 0.1-0.3mm; the width of the straight groove 236 in the fourth cutting groove is 0.1-0.3mm. The two ends of each third cutting groove are a fifth end 231 and a sixth end 232, respectively, the line connecting the fifth ends 231 of the respective third cutting grooves is a straight line, the line connecting the sixth ends 232 of the respective third cutting grooves is a straight line, and the line connecting the fifth ends 231 of the respective third cutting grooves is parallel to the line connecting the sixth ends 232 of the respective third cutting grooves. The two ends of each fourth cutting groove are a seventh end 234 and an eighth end 235, respectively, the line connecting the seventh ends 234 of the fourth cutting grooves is a straight line, the line connecting the eighth ends 235 of the fourth cutting grooves is a straight line, and the line connecting the seventh ends 234 of the fourth cutting grooves is parallel to the line connecting the eighth ends 235 of the fourth cutting grooves. The included angle between the connecting line of the fifth end 231 of each third cutting groove and the axis of the renal artery radio frequency ablation catheter is 0.2-0.8 degrees; the line connecting the sixth end 232 of each third cutting slot is at an angle of 0.2-0.8 deg. to the axis of the renal artery radio frequency ablation catheter. The included angle between the connecting line of the seventh end 234 of each fourth cutting groove and the axis of the renal artery radio frequency ablation catheter is 0.2-0.8 degrees; the line connecting the eighth ends 235 of each fourth cutting flute is at an angle of 0.2-0.8 ° to the axis of the renal artery radio frequency ablation catheter.

The fourth set of cutting flutes includes a plurality of fifth cutting flutes, the plurality of fifth cutting flutes being parallel to one another. The distance between two adjacent fifth cutting grooves is 0.5-1.3mm, preferably 0.59mm. Each fifth cutting groove extends along the circumference of the pipe wall of the metal pipe layer 100 by a length greater than half of the circumference of the metal pipe layer 100. The fourth set of cutting flutes extends in the axial direction of the carrier 62 at the wall of the metal tube layer 100 for a length of 1.5-4.5mm, preferably 2.28mm. Each fifth cutting slot has two ends with circular holes, and a straight slot 243 is located between the two ends of each fifth cutting slot. The diameter of the circular holes at both ends of the fifth cutting groove is 0.15-0.45mm. The width of the straight groove 243 in the fifth cutting groove is 0.1-0.3mm. The two ends of each fifth cutting groove are a ninth end 241 and a tenth end 242, respectively, the line connecting the ninth ends 241 of each fifth cutting groove is a straight line, the line connecting the tenth ends 242 of each fifth cutting groove is a straight line, and the line connecting the ninth ends 241 of each fifth cutting groove is parallel to the line connecting the tenth ends 242 of each fifth cutting groove. The included angle between the connecting line of the ninth end part 241 of each fifth cutting groove and the axis of the renal artery radio frequency ablation catheter is 0.2-0.8 degrees; the line connecting the tenth ends 242 of each fifth cutting slot is at an angle of 0.2-0.8 deg. to the axis of the renal artery radio frequency ablation catheter.

In this embodiment, the spacing between the first set of cutting grooves and the second set of cutting grooves is 0.3-0.5mm, the spacing between the second set of cutting grooves and the third set of cutting grooves is 0.1-0.4mm, and the spacing between the third set of cutting grooves and the fourth set of cutting grooves is 0.1-0.4mm.

In a preferred embodiment of the present invention, the first set of cutting flutes comprises a plurality of mutually parallel first cutting flutes, each having a first end portion 211 and a second end portion 212 opposite the first end portion 211; the second set of cutting flutes includes a plurality of mutually parallel second cutting flutes, each having a third end 221 and a fourth end 222 opposite the third end 221; the third set of cutting slots includes a plurality of third cutting slots parallel to each other and a plurality of fourth cutting slots parallel to each other, each third cutting slot having a fifth end 231 and a sixth end 232 opposite the fifth end 231, each fourth cutting slot having a seventh end 234 and an eighth end 235 opposite the seventh end 234; the fourth set of cutting flutes includes a plurality of fifth cutting flutes parallel to each other, the fifth cutting flutes having a ninth end portion 241 and a tenth end portion 242 opposite the ninth end portion 241.

Wherein, the distance between the first end 211 and the third end 221 in the direction perpendicular to the axis of the renal artery radio frequency ablation catheter is 0-0.25mm, the distance between the third end 221 and the fifth end 231 in the direction perpendicular to the axis of the renal artery radio frequency ablation catheter is 0.4-0.6mm, the distance between the fifth end 231 and the seventh end 234 in the direction perpendicular to the axis of the renal artery radio frequency ablation catheter is 0.3-0.7mm, and the distance between the seventh end 234 and the ninth end 241 in the direction perpendicular to the axis of the renal artery radio frequency ablation catheter is 0.35-0.65mm.

In other words, the distance between the second end 212 and the fourth end 222 in the direction perpendicular to the axis of the renal artery radiofrequency ablation catheter is 1.45-2.5mm, the distance between the fourth end 222 and the sixth end 232 in the direction perpendicular to the axis of the renal artery radiofrequency ablation catheter is 0.35-0.65mm, the distance between the sixth end 232 and the eighth end 235 in the direction perpendicular to the axis of the renal artery radiofrequency ablation catheter is 0.35-0.7mm, and the distance between the eighth end 235 and the tenth end 242 in the direction perpendicular to the axis of the renal artery radiofrequency ablation catheter is 0.45-1.5mm.

In another preferred embodiment of the present invention, as shown in fig. 9, the wall of the fifth section 250 of the metal pipe layer 100 has sixth cutting grooves, which are spiral grooves 251 cut around the circumference of the metal pipe layer 100, and the interval between each turn of spiral grooves 251 is gradually increased in the distal to proximal direction of the fifth section 250, and the width of the spiral grooves 251 is 0.1-0.3mm.

In yet another preferred embodiment of the present invention, as shown in fig. 10, the first set of cutting flutes 210 comprises a plurality of mutually parallel elliptical flutes, each of which extends less than half the circumference of the metal tube layer 100 along the circumference of the tube wall of the metal tube layer 100.

After the pipe wall of the metal pipe layer 100 of the bearing member 62 of the embodiment of the present invention is cut into the combination groove, when the wire is pulled tight, the bearing member 62 is in the second shape, that is, the foremost end of the metal pipe layer 100 is straight (about 10 mm), then gradually transitions to a spiral shape (the straight length of the spiral portion is about 35 mm), and then gradually transitions from the spiral shape to the straight shape. The advantage of the combined groove on the metal pipe layer 100 of the present embodiment, compared to the non-combined groove, is that: (1) A smooth transition from straight to spiral and vice versa can be achieved, where a smooth transition refers to a transition between straight and spiral without abrupt angles of refraction, but a smooth curve; (2) The combination groove facilitates the spiral shape of the bearing part; (3) The combination of grooves makes it possible to easily achieve the actually desired spiral parameters for the spiral shape of the carrier member.

In an embodiment of the invention, when the carrier is in the second shape, the spacing between adjacent cut grooves having a spiral-shaped portion (such as the third section 230 of the metal tube layer) therein is zero, i.e., the cut grooves in the portion having the spiral shape are in close contact.

The foregoing describes in detail preferred embodiments of the present invention. It should be understood that numerous modifications and variations can be made in accordance with the concepts of the invention by one of ordinary skill in the art without undue burden. Therefore, all technical solutions which can be obtained by logic analysis, reasoning or limited experiments based on the prior art by the person skilled in the art according to the inventive concept shall be within the scope of protection defined by the claims.

Claims

1. The renal artery radiofrequency ablation catheter comprises an electrode for transmitting adjustment energy to a nerve and a bearing component for bearing the electrode, and is characterized in that the bearing component is of a tubular structure with a cavity and comprises a metal tube layer, the metal tube layer sequentially comprises a first section, a second section, a third section, a fourth section and a fifth section along the direction from the distal end to the proximal end of the bearing component, the tube wall of the first section is provided with a first group of cutting grooves, the tube wall of the second section is provided with a second group of cutting grooves, the tube wall of the third section is provided with a third group of cutting grooves, and the tube wall of the fourth section is provided with a fourth group of cutting grooves; wherein,

the spacing between the grooves in the second group of cutting grooves is larger than the spacing between the grooves in the third group of cutting grooves, so that when the bearing part is subjected to the action of extrusion force along the axial direction, the first section of the metal pipe layer is smoothly connected with the third section through the second section;

The spacing between the grooves in the fourth set of cutting grooves is greater than the spacing between the grooves in the third set of cutting grooves, so that when the bearing component is subjected to the axial extrusion force, the third section of the metal tube layer is smoothly connected with the fifth section through the fourth section.

2. The renal artery radio frequency ablation catheter of claim 1, wherein upon removal of said axially directed compressive force, said second segment, said third segment, and said fourth segment revert to a straight shape.

3. The renal artery radio frequency ablation catheter of claim 1, wherein said first set of cutting flutes comprises a plurality of first cutting flutes, wherein a plurality of said first cutting flutes are parallel to one another.

4. The renal artery radio frequency ablation catheter of claim 3, wherein a spacing between adjacent ones of the first cutting flutes is 0.55-0.8 mm.

5. The renal artery radio frequency ablation catheter of claim 3, wherein each of said first cutting flutes extends less than half the circumference of said metal tube layer along the circumference of the tube wall of said metal tube layer.

6. A renal artery radio frequency ablation catheter as defined in claim 3, wherein said first plurality of cutting flutes extend along an axial direction of said carrier member at a wall of said metal tube layer for a length of 4-8 mm.

7. The renal artery radio frequency ablation catheter of claim 3, wherein each of said first cutting flutes has two ends with a circular or approximately circular aperture, and wherein a linear flute is located between the two ends of each of said first cutting flutes.

8. The renal artery radio frequency ablation catheter of claim 7, wherein the circular holes at both ends of the first cutting slot have a diameter of 0.2-0.5 mm.

9. The renal artery radio frequency ablation catheter of claim 7, wherein a width of a linear slot in the first cutting slot is 0.1-0.25 mm.

10. The renal artery radio frequency ablation catheter of claim 7, wherein each of said first cutting flutes has a first end and a second end, wherein a line connecting the first ends of each of said first cutting flutes is a straight line, wherein a line connecting the second ends of each of said first cutting flutes is a straight line, and wherein a line connecting the first ends of each of said first cutting flutes is parallel to a line connecting the second ends of each of said first cutting flutes.

11. The renal artery radio frequency ablation catheter of claim 10, wherein a line connecting the first ends of each of the first cutting flutes forms an angle of 0-5 ° with an axis of the renal artery radio frequency ablation catheter; the included angle between the connecting line of the second end part of each first cutting groove and the axis of the renal artery radio frequency ablation catheter is 0-5 degrees.

12. The renal artery radio frequency ablation catheter of claim 1, wherein said second set of cutting flutes comprises a plurality of second cutting flutes, a plurality of said second cutting flutes being parallel to one another.

13. The renal artery radio frequency ablation catheter of claim 12, wherein a spacing between adjacent two of said second cutting flutes is 0.6-0.9. 0.9 mm.

14. The renal artery radio frequency ablation catheter of claim 12, wherein each of said second cutting flutes extends along a circumference of a wall of said metal tube layer for a length greater than half a circumference of said metal tube layer.

15. The renal artery radio frequency ablation catheter of claim 12, wherein the second plurality of cutting flutes extend in the axial direction of the carrier member at a wall of the metal tube layer for a length of 8-12 mm.

16. The renal artery radio frequency ablation catheter of claim 12, wherein each of said second cutting flutes has two ends with circular holes, and wherein a linear slot is defined between the two ends of each of said second cutting flutes.

17. The renal artery radio frequency ablation catheter of claim 16, wherein the circular holes at both ends of the second cutting slot have a diameter of 0.2-0.5 mm.

18. The renal artery radio frequency ablation catheter of claim 16, wherein a width of a linear slot in the second cutting slot is 0.1-0.3 mm.

19. The renal artery radio frequency ablation catheter of claim 15, wherein each of said second cutting flutes has a third end portion and a fourth end portion, wherein a line connecting said third end portions of each of said second cutting flutes is a straight line, wherein a line connecting said fourth end portions of each of said second cutting flutes is a straight line, and wherein a line connecting said third end portions of each of said second cutting flutes is parallel to a line connecting said fourth end portions of each of said second cutting flutes.

20. The renal artery radio frequency ablation catheter of claim 17, wherein a line connecting the third ends of each of the second cutting flutes forms an angle of 0.2-0.8 ° with an axis of the renal artery radio frequency ablation catheter; the included angle between the connecting line of the fourth end part of each second cutting groove and the axis of the renal artery radio frequency ablation catheter is 0.2-0.8 degrees.

21. The renal artery radio frequency ablation catheter of claim 1, wherein said third set of cutting flutes comprises a plurality of third cutting flutes and a plurality of fourth cutting flutes, wherein a plurality of said third cutting flutes are parallel to each other and a plurality of said fourth cutting flutes are parallel to each other.

22. The renal artery radio frequency ablation catheter of claim 21, wherein a spacing between adjacent ones of said third cutting flutes is between 0.4 and 0.8 and mm, a spacing between adjacent ones of said fourth cutting flutes is between 0.4 and 0.8 and mm, and a spacing between a third cutting flute proximal of a plurality of said third cutting flutes and a fourth cutting flute distal of a plurality of said fourth cutting flutes is between 0.15 and 0.35 and mm.

23. The renal artery radio frequency ablation catheter of claim 21, wherein each of said third cutting groove and each of said fourth cutting groove extends along a circumference of a wall of said metal tube layer for a length greater than half a circumference of said metal tube layer.

24. The renal artery radio frequency ablation catheter of claim 21, wherein the third plurality of cutting flutes extend in the axial direction of the carrier member at a wall of the metal tube layer for a length of 8-16 mm.

25. The renal artery radio frequency ablation catheter of claim 21, wherein a plurality of said third cutting flutes of said third set of cutting flutes extend in an axial direction of said carrier member at a wall of said metal tube layer for a length of 1.5-4.5 mm, and wherein a plurality of said fourth cutting flutes of said third set of cutting flutes extend in an axial direction of said carrier member at a wall of said metal tube layer for a length of 1.5-4.5 mm.

26. The renal artery radio frequency ablation catheter of claim 21, wherein each of said third cutting flutes has two ends with circular holes, and wherein a straight flute is provided between the two ends of each of said third cutting flutes; each fourth cutting groove is provided with two ends with round holes, and a straight line groove is arranged between the two ends of each fourth cutting groove.

27. The renal artery radio frequency ablation catheter of claim 26, wherein the circular holes at both ends of the third cutting slot have a diameter of 0.2-0.5 mm; the diameter of the circular holes at both ends of the fourth cutting groove is 0.2-0.5. 0.5 mm.

28. The renal artery radio frequency ablation catheter of claim 27, wherein a width of a linear slot in the third cutting slot is 0.1-0.3mm; the width of the straight line groove in the fourth cutting groove is 0.1-0.3mm.

29. The renal artery radio frequency ablation catheter of claim 25, wherein each of said third cutting flutes has a fifth end portion and a sixth end portion, wherein a line connecting the fifth end portions of each of said third cutting flutes is a straight line, wherein a line connecting the sixth end portions of each of said third cutting flutes is a straight line, and wherein a line connecting the fifth end portions of each of said third cutting flutes is parallel to a line connecting the sixth end portions of each of said third cutting flutes.

30. The renal artery radio frequency ablation catheter of claim 29, wherein each of said fourth cutting flutes has a seventh end portion and an eighth end portion, wherein a line connecting the seventh end portions of each of said fourth cutting flutes is a straight line, wherein a line connecting the eighth end portions of each of said fourth cutting flutes is a straight line, and wherein a line connecting the seventh end portions of each of said fourth cutting flutes is parallel to a line connecting the eighth end portions of each of said fourth cutting flutes.

31. The renal artery radio frequency ablation catheter of claim 30, wherein a line connecting a fifth end of each of the third cutting flutes forms an angle of 0.2-0.8 ° with an axis of the renal artery radio frequency ablation catheter; the included angle between the connecting line of the sixth end part of each third cutting groove and the axis of the renal artery radio frequency ablation catheter is 0.2-0.8 degrees.

32. The renal artery radio frequency ablation catheter of claim 31, wherein a line connecting a seventh end of each of the fourth cutting flutes forms an angle of 0.2-0.8 ° with an axis of the renal artery radio frequency ablation catheter; the included angle between the connecting line of the eighth end part of each fourth cutting groove and the axis of the renal artery radio frequency ablation catheter is 0.2-0.8 degrees.

33. The renal artery radio frequency ablation catheter of claim 1, wherein said fourth set of cutting flutes comprises a plurality of fifth cutting flutes, a plurality of said fifth cutting flutes being parallel to one another.

34. The renal artery radio frequency ablation catheter of claim 33, wherein a spacing between adjacent ones of said fifth cutting flutes is between 0.5 and 1.3 mm.

35. The renal artery radio frequency ablation catheter of claim 33, wherein each of said fifth cutting flutes extends along a circumference of a wall of said metal tube layer for a length greater than half a circumference of said metal tube layer.

36. The renal artery radio frequency ablation catheter of claim 33, wherein the fourth set of cutting flutes extend in the axial direction of the carrier member at the wall of the metal tube layer for a length of 1.5-4.5 mm.

37. The renal artery radio frequency ablation catheter of claim 33, wherein each of said fifth cutting flutes has two ends with circular holes, and wherein a linear slot is defined between the two ends of each of said fifth cutting flutes.

38. The renal artery radio frequency ablation catheter of claim 37, wherein the circular holes at both ends of the fifth cutting slot have a diameter of 0.15-0.45 mm.

39. The renal artery radio frequency ablation catheter of claim 37, wherein a width of a linear slot in said fifth cutting slot is 0.1-0.3 mm.

40. The renal artery radio frequency ablation catheter of claim 38, wherein each of said fifth cutting flutes has a ninth end and a tenth end, respectively, wherein a line connecting the ninth ends of each of said fifth cutting flutes is a straight line, wherein a line connecting the tenth ends of each of said fifth cutting flutes is a straight line, and wherein a line connecting the ninth ends of each of said fifth cutting flutes is parallel to a line connecting the tenth ends of each of said fifth cutting flutes.

41. The renal artery radio frequency ablation catheter of claim 40, wherein a line of the ninth end of each of said fifth cutting flutes forms an angle of 0.2 to 0.8 ° with the axis of said renal artery radio frequency ablation catheter; the included angle between the connecting line of the tenth end part of each fifth cutting groove and the axis of the renal artery radio frequency ablation catheter is 0.2-0.8 degrees.

42. The renal artery radio frequency ablation catheter of claim 1, wherein a spacing between the first set of cutting flutes and the second set of cutting flutes is 0.3-0.5 mm, a spacing between the second set of cutting flutes and the third set of cutting flutes is 0.1-0.4 mm, and a spacing between the third set of cutting flutes and the fourth set of cutting flutes is 0.1-0.4 mm.

43. The renal artery radio frequency ablation catheter of claim 1, wherein said first set of cutting flutes comprises a plurality of first cutting flutes parallel to one another, each said first cutting flute having a first end portion and a second end portion opposite said first end portion; the second set of cutting flutes comprising a plurality of mutually parallel second cutting flutes, each having a third end portion and a fourth end portion opposite the third end portion; the third set of cutting flutes including a plurality of mutually parallel third cutting flutes and a plurality of mutually parallel fourth cutting flutes, each third cutting flute having a fifth end portion and a sixth end portion opposite the fifth end portion, each fourth cutting flute having a seventh end portion and an eighth end portion opposite the seventh end portion; the fourth set of cutting flutes includes a plurality of mutually parallel fifth cutting flutes having a ninth end portion and a tenth end portion opposite the ninth end portion.

44. The renal artery radio frequency ablation catheter of claim 43, wherein said first end is spaced from said third end by a distance of 0-0.25 mm in a direction perpendicular to the axis of said renal artery radio frequency ablation catheter, wherein said third end is spaced from said fifth end by a distance of 0.4-0.6 mm in a direction perpendicular to the axis of said renal artery radio frequency ablation catheter, wherein said fifth end is spaced from said seventh end by a distance of 0.3-0.7 mm in a direction perpendicular to the axis of said renal artery radio frequency ablation catheter, and wherein said seventh end is spaced from said ninth end by a distance of 0.35-0.65 mm in a direction perpendicular to the axis of said renal artery radio frequency ablation catheter.

45. The renal artery radio frequency ablation catheter of claim 43, wherein said second end is spaced from said fourth end by a distance of 1.45-2.5 mm in a direction perpendicular to the axis of said renal artery radio frequency ablation catheter, wherein said fourth end is spaced from said sixth end by a distance of 0.35-0.65 mm in a direction perpendicular to the axis of said renal artery radio frequency ablation catheter, wherein said sixth end is spaced from said eighth end by a distance of 0.35-0.7 mm in a direction perpendicular to the axis of said renal artery radio frequency ablation catheter, and wherein said eighth end is spaced from said tenth end by a distance of 0.45-1.5 mm in a direction perpendicular to the axis of said renal artery radio frequency ablation catheter.

46. The renal artery radio frequency ablation catheter of claim 1, wherein a wall of the fifth section of the metal tube layer has a sixth cut groove, wherein the sixth cut groove is a spiral groove formed by cutting around a circumference of the metal tube layer, and a distance between each circle of the spiral groove gradually increases along a distal end to proximal end direction of the fifth section, and a width of the spiral groove is 0.1-0.3 mm.

47. The renal artery radio frequency ablation catheter of claim 1, wherein said first plurality of cutting flutes comprises a plurality of mutually parallel elliptical flutes, each of said elliptical flutes extending less than half the circumference of said metal tube layer along the circumference of the tube wall.

48. The renal artery radio frequency ablation catheter of claim 1, wherein the metal tube layer is of NiTi alloy.

49. The renal artery radio frequency ablation catheter of claim 1, wherein the outer wall of the metal tube layer is coated with an insulating layer, and the insulating layer is made of TPU or Pebax.

50. The renal artery radio frequency ablation catheter of claim 47, further comprising a delivery member for delivering said carrier member and said electrode to a location of said nerve in need of modulation.

51. The renal artery radio frequency ablation catheter of claim 50, wherein a distal end of said delivery member is connected to a proximal end of said carrier member.

52. The renal artery radio frequency ablation catheter of claim 50, wherein said delivery member is a hollow tubular structure comprising, in order radially outwardly of said tubular structure, a metal tube layer of NiTi alloy or stainless steel material, and a polymer layer of PET, FEP or PTFE.

53. The renal artery radio frequency ablation catheter of claim 52, further comprising a handle for grasping by a user, said handle being connected to a proximal end of said delivery member.

54. The renal artery radio frequency ablation catheter of claim 53, wherein said handle is integral with a connection cable of an external energy generator.

55. The renal artery radio frequency ablation catheter of claim 53, wherein said electrode is welded to a lead for delivering regulatory energy and feedback temperature, impedance.

56. The renal artery radio frequency ablation catheter of claim 55, wherein said electrode is soldered to said lead by solder, and wherein the solder joint is covered by an insulating layer.

57. The renal artery radio frequency ablation catheter of claim 55, wherein said electrode is soldered to said lead wire by gold or silver, and wherein the solder joint is bare or covered by an insulating layer.

58. The renal artery radio frequency ablation catheter of claim 56 or 57, wherein said lead is disposed inside said insulating layer of said carrier member and is welded to said electrode by passing out of an outermost layer of said insulating layer of said carrier member; the lead wire extends inside the insulating layer of the bearing part and inside the polymer layer of the conveying part, and is installed in the handle.

59. The renal artery radio frequency ablation catheter of claim 53, wherein a pull wire is disposed within said cavity of said carrier member, said pull wire being capable of subjecting said carrier member to an axially compressive force.

60. The renal artery radio frequency ablation catheter of claim 59, wherein a distal end of said pull wire is secured to an inner wall at a distal end of said carrier member, and wherein a proximal end of said pull wire is coupled to a control member disposed within said handle for controlling tightening or loosening of said pull wire.

61. The renal artery radio frequency ablation catheter of claim 59, wherein said carrier member is subjected to an axially compressive force by tightening said pull wire, said third section of said metal tube layer being helical when said pull wire is tightened; when the pull wire is released, the third segment returns to a straight shape.

62. The renal artery radio frequency ablation catheter of claim 61, wherein when said third section of said metal tube layer is helical, said helix has a helix diameter of 4 to 14 mm, a pitch of 3 to 8 mm, and a number of turns of said helix of 1 to 2.

63. The renal artery radio frequency ablation catheter of claim 59, wherein said distal end of said pull wire is welded to an inner wall of said carrier member by a resistance welder.

64. The renal artery radio frequency ablation catheter of claim 59, wherein said pull wire has a diameter of 0.1-0.25 mm.

65. The renal artery radio frequency ablation catheter of claim 59, wherein said pull wire is made of NiTi alloy wire or stainless steel wire.

66. The renal artery radio frequency ablation catheter of claim 1, wherein the electrode is made by tightly wrapping a wire electrode around the carrier member by a wire winding machine or manually.

67. The renal artery radio frequency ablation catheter of claim 66, wherein the wire electrode has a diameter of 0.05 mm to 0.25 mm.

68. The renal artery radio frequency ablation catheter of claim 66, wherein both ends of said wire electrode are bonded to said carrier member with glue, thereby securing said wire electrode to said carrier member.

69. The renal artery radio frequency ablation catheter of claim 66, wherein said wire electrode is secured to said carrier member by heat shrinking insulation layers on both ends of said wire electrode.

70. The renal artery radio frequency ablation catheter of claim 66, wherein said wire electrode is made of platinum iridium alloy or gold.

71. The renal artery radio frequency ablation catheter of claim 66, wherein said electrode is a continuous electrode tightly wrapped with said wire electrode.

72. The renal artery radio frequency ablation catheter of claim 71, wherein the distance between adjacent turns of wire electrode is 0-0.5 mm and the length of said continuous electrode extending over said carrier member is 10-45 mm.

73. The renal artery radio frequency ablation catheter of claim 71, wherein said continuous electrode is welded with 1-8 sets of wires.

74. The renal artery radio frequency ablation catheter of claim 66, wherein said electrodes are grouped electrodes wound from said wire electrode into groups, said wire electrode in each group being tightly wound.

75. The renal artery radio frequency ablation catheter of claim 74, wherein in each group of electrodes of said group of electrodes, the distance between adjacent turns of wire electrodes 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 component is 2-5 mm.

76. The renal artery radio frequency ablation catheter of claim 74, wherein each set of electrodes of said group of electrodes is welded with a set of wires.

77. The renal artery radiofrequency ablation catheter of claim 1, wherein the distal end of the carrier member is provided with a protective member for reducing or avoiding damage to the vessel wall.

78. The renal artery radio frequency ablation catheter of claim 77, wherein said protective member is formed of an elastic material.

79. The renal artery radio frequency ablation catheter of claim 78, wherein said elastic material is rubber, silicone, or a thermoplastic elastomer.

80. The renal artery radio frequency ablation catheter of claim 77, wherein said protective member has a length of from 3 to 15 mm and a maximum diameter of less than 1.33 mm.

81. The renal artery radio frequency ablation catheter of claim 50, wherein said delivery member is integral with said carrier member.

82. The renal artery radio frequency ablation catheter of claim 50, wherein said delivery member and said carrier member each have an outer diameter of 0.55mm to 1.0 mm and a wall thickness of 0.05 to 0.15 mm.