WO2017132935A1 - Multi-electrode renal artery ablation catheter - Google Patents

Abstract

A multi-electrode renal artery ablation catheter, comprising a regulating component (100) for regulating nerves, a conveying member (201) for conveying the regulating conditioning component (100) to a position of a nerve, and a sheath (301). The regulating component (100) comprises a plurality of electrodes (101) for transferring regulating energy to the nerve and a carrier member (102) for carrying a plurality of electrodes (101). The carrier member (102) has a first shape and a second shape. The regulating component (100) is adapted to move in a blood vessel when the carrier member is in the first shape. When in the second shape, at least one of the electrodes (101) is at a position suitable for transferring the regulating energy to the nerve. The sheath (301) is sleeved over the conveying member (201) and is slidable along the conveying member (201) and is sleeved over or disengaged from the regulating component (100). A guide wire channel (500) is arranged within the multi-electrode renal artery ablation catheter, and the guide wire channel (500) penetrates throughout the entire multi-electrode renal artery ablation catheter. The carrier member (102) can be switched between the first shape and second shape by means of a solo action of the sheath (301) or a guide wire, or by a combined action of the sheath (301) and the guide wire.

Description

 Multi-electrode renal artery radiofrequency ablation catheter

Technical field

The present invention relates to electrosurgery, and more particularly to a multi-electrode renal artery radiofrequency ablation catheter.

Background technique

Refractory hypertension, which is still difficult to control with 3 or more drugs (both already using a diuretic) (sBP ≥ 160mmHg ), it is more common in clinical, its pathogenic factors are numerous, the pathogenesis is not clear, the drug treatment effect is very poor, and the diagnosis and treatment techniques are still not mature enough, which has become one of the major problems in the treatment of hypertension.

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

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

Although related instruments for regulating renal artery sympathetic nerves have been reported in related literatures or patents, currently existing instruments have drawbacks such as inconvenient operation, high manufacturing cost, or inefficiency, such as electrode bearing members cannot provide sufficient supporting force, The electrode bearing member has a large frictional force at the cutting portion.

Accordingly, the present invention provides a novel multi-electrode renal artery radiofrequency ablation catheter.

Summary of the invention

In view of the above-mentioned deficiencies of the prior art, the technical problem to be solved by the present invention is to provide a catheter device for regulating renal nerves and treating related diseases with convenient operation, low production cost, and high efficiency.

To achieve the above object, the present invention provides a multi-electrode renal artery ablation catheter,

An adjustment assembly for modulating a nerve and a delivery member for delivering the adjustment assembly to a location of the nerve;

The adjustment assembly includes a plurality of electrodes for delivering modulated energy to the nerve and a carrier member for carrying a plurality of the electrodes;

The carrier member has a first shape and a second shape, the adjustment assembly being adapted to move within a blood vessel; and in the second shape, at least one of the electrodes is adapted to adjust the The location at which energy is delivered to the nerve;

Characterizing in that the multi-electrode renal artery ablation catheter further comprises a sheath; the sheath is sheathed to the delivery member, the sheath being slidable along the delivery member and sheathed or detached from the adjustment assembly;

The interior of the multi-electrode renal artery ablation catheter is provided with a guidewire channel extending throughout the multi-electrode renal artery ablation catheter for guiding a guidewire at the multi-electrode renal artery ablation The interior of the catheter moves axially along the multi-electrode renal artery ablation catheter;

The multi-electrode renal artery ablation catheter is configured to enable the carrier member to be in the described manner by the separate action of the sheath or the guidewire or by the interaction of the sheath and the guidewire Switching between the first shape and the second shape.

Further, the separate function of the sheath means that the carrier member is switched from the second shape to the first shape when the sheath tube slides along the conveying member and is sheathed to the adjustment assembly; The carrier member is switched from the first shape to the second shape when the sheath slides along the transport member and disengages from the adjustment assembly.

Further, the guide wire channel has an opening at both the proximal end and the distal end.

Further, the separate action of the guide wire means that when the guide wire is inserted into the guide wire passage from the opening of the distal end of the guide wire passage into the interior of the carrier member, The carrier member is switched from the second shape to the first shape; when the guide wire exits from the proximal end opening of the guidewire channel and is withdrawn from the interior of the carrier member, The carrier member is switched from the first shape to the second shape.

Further, the interaction of the sheath tube and the guide wire means that the sheath tube slides along the delivery member and is sheathed to the adjustment assembly while the guide wire is from the guide wire channel The load bearing member is switched from the second shape to the first shape when the distal end opening is inserted into the guide wire passage into the interior of the carrier member; when the guide wire is from the guide The proximal end opening of the wire passage exits and pulls away from the carrier member while the sheath slides along the transport member and disengages from the adjustment assembly, the carrier member is switched from the first shape to The second shape.

Further, the carrier member and the conveying member are both tubular, and the polymer layer and the NiTi are sequentially arranged from the inside to the outside in the radial direction of the tubular shape. Tube, inner insulating layer and outer insulating layer.

Further, the polymer layer of the carrier member and the polymer layer of the conveying member have a diameter of 0.40 to 0.55 mm, and the thickness is 0.025~0.1 mm.

Further, the polymer layer of the carrier member and the polymer layer of the transport member are integrated and formed of a polymer material.

Further, the polymer material is PET, FEP, Pebax, PE or PTFE.

Further, the surface of the NiTi tube of the bearing member has a cutting pattern, and the cutting pattern is laser-cut on the bearing member. A spiral groove formed on the surface of the NiTi tube.

Further, when the carrier member is in the first shape, the projection of the spiral groove in a horizontal plane includes a plurality of linear grooves and a plurality of approximate linear grooves.

Further, the plurality of linear grooves are located at a distal end of the bearing member, and the plurality of linear grooves comprise a plurality of first linear grooves and a plurality of second linear grooves.

Further, each of the two adjacent first linear grooves has the same pitch, and the plurality of the first linear grooves are parallel to each other.

Further, the spacing of each of the two adjacent second linear grooves is the same, and the plurality of the second linear grooves are parallel to each other.

Further, an angle between the first linear groove and the axial direction of the bearing member is 75° to 85° The angle between the second linear groove and the axial direction of the bearing member is 65°~75°, and the angle between the approximate linear groove and the axial direction of the bearing member is 50°~65° The axial direction refers to a direction from the proximal end of the carrier member to the distal end of the carrier member when the carrier member is in the first shape.

Further, the plurality of approximate linear grooves are located at a proximal end of the bearing member, and a distance between two adjacent linear grooves is gradually increased from a distal end to a proximal end of the bearing member. A plurality of said approximate linear grooves are not parallel to each other.

Further, the inner insulating layer of the bearing member and the inner insulating layer of the conveying member are both PET heat shrinkable tubes, and the thickness after heat shrinking is 0.012~0.05 mm.

Further, the outer insulating layer of the bearing member is a TPU tube or a Pebax tube, and the diameter is 0.9 to 1.2 mm, and the thickness is 0.05~0.15mm.

Further, the outer insulating layer of the conveying member is a PET or FEP heat-shrinkable tube, and the thickness after heat shrinking is 0.012~0.1 mm. .

Further, the electrode is sleeved on the outside of the outer insulating layer of the carrier member and is reinforced by an adhesive.

Further, the binder is a UV curable adhesive or an epoxy resin adhesive.

Further, a plurality of said electrodes individually control the release of energy.

Further, a plurality of said electrodes simultaneously control the release of energy.

Further, the inner surface of each of the electrodes is connected to a wire for providing the electrode with the conditioning energy and monitoring the temperature and impedance at the time of ablation.

Further, the wire is disposed between the outer insulating layer and the inner insulating layer of the carrier member and extends between the outer insulating layer and the inner insulating layer of the conveying member.

Further, the wire passes through the outer insulating layer of the carrier member and the inner surface of the electrode is soldered or laser welded together.

Further, the first shape of the load bearing member is straight or approximately straight.

Further, the second shape of the carrier member is spiral or approximately spiral.

Further, the spiral shape or the approximate spiral shape has a diameter of 4 to 12 mm and a pitch of 3 to 10 mm.

Further, the carrier member is irritating and pre-processed to have the first shape.

Further, the electrode has a circular cross section.

Further, the number of the electrodes is 2-6, and when the carrier member is in the second shape, the distance between adjacent electrodes is 4~12 mm.

Further, the electrode is made of platinum-rhodium alloy or gold.

Further, the multi-electrode renal artery ablation catheter further includes a handle for gripping, the handle being coupled to a proximal end of the delivery member, the distal end of the handle being coupled to a proximal end of the delivery member.

Further, a control mechanism is provided in the handle, and the control mechanism is used to control the movement of the sheath.

Further, the control mechanism includes a tip, a tooth block and a gear, the end is located at a distal end of the handle and is connected to the sheath, and the tooth block is connected to the end, the gear and The tooth block is matched; rotating the gear enables the tooth block to push and pull the end, such that the tip pushes and pulls the sheath tube along the conveying member.

Further, the carrier member and the conveying member are unitary.

Further, the proximal end of the carrier member is coupled to the distal end of the delivery member.

Further, the sheath has an inner diameter of 1.2 to 1.45 mm and an outer diameter of 1.3 to 1.55 mm.

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

Further, the inner layer is made of PTFE and has a wall thickness of 0.015 to 0.5 mm.

Further, the outer layer is Pebax or TPU, and the Pebax or TPU contains 20 wt% to 40 wt% BaSO ₄ or 10 wt% to 30 wt% BiOCl.

Further, the remainder of the outer layer has a braided mesh tube except for the portion of the outer layer that is 1 to 5 mm from the most distal end of the sheath.

Further, the braided mesh tube includes a first braided wire segment, a second braided wire segment, and a third braided wire segment.

Further, the braided wire of the first braided wire segment, the second braided wire segment and the third braided wire segment is a stainless steel wire or a NiTi wire.

Further, the braided wires of the first braided wire segment, the second braided wire segment and the third braided wire segment are differently prepared such that the sheath tube is adjacent to the distal end of the handle 10-20 cm The hardness of the portion is greater than the hardness of the other portions of the sheath.

Further, the hardness of the distal end of the sheath has a transition from small to large, facilitating entry of the multi-electrode renal artery ablation catheter into a predetermined location of the renal artery.

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

Further, the protective member is a soft head.

Further, the soft head has an opening for the guide wire to be inserted into the carrier member, and the opening of the soft head is an opening at the distal end of the guide wire channel.

Further, the protective member is made of rubber, silicone or a thermoplastic elastomer material.

Further, the nerve is a renal sympathetic nerve located on a human renal artery, and the 'position close to the nerve' Refers to being located within the renal artery.

Further, the regulation refers to the removal or reduction of activation of the nerve by damage or non-injury.

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

Further, the blood vessel is a human renal artery.

Further, the phrase 'suitable for movement in a blood vessel' means that the adjustment assembly does not damage the vessel wall when the adjustment assembly moves within the blood vessel.

Further, the phrase 'suitable for moving in a blood vessel' means that the maximum dimension of the adjustment assembly in the radial direction of the blood vessel is not greater than the inner diameter of the blood vessel.

Further, the phrase 'suitable for moving in a blood vessel' means that the maximum dimension of the adjustment component in the radial direction of the blood vessel is not more than 3 mm. .

Further, the phrase 'suitable for moving in a blood vessel' means that it is easy to bend a segment through a blood vessel.

Further, the phrase 'suitable for transmitting the modulated energy to the renal nerve' refers to a position at which at least one electrode is in contact with the blood vessel wall when the regulating member is in a blood vessel.

Further, the 'location suitable for transferring the modulated energy to the renal nerve' means that the maximum dimension of the adjustment component in the radial direction of the blood vessel is 4-12 mm. At least one of the electrodes is at the largest dimension.

The multi-electrode renal artery radiofrequency ablation catheter of the present invention has the following advantages over existing catheter devices:

( 1 The invention is provided with a guide wire channel, and the distal end of the bearing member, that is, the front end of the catheter has an opening, and the guide wire can enter the guide wire passage through the opening during use, which is convenient to operate and conforms to the doctor's usage habits.

( 2 By designing a unique cut pattern and coating the insulating layer, the load bearing member can provide a sufficient radial support force in a second shape (spiral or approximately spiral) to better approximate the vessel wall.

(3 During use, the guide wire and the sheath can work together, that is, after the sheath is disposed, the guide wire can be accurately controlled to move within the guide wire channel, thereby enabling the spiral having a sufficiently large radial support force to be straightened. .

(4) The inner wall of the bearing member and the transmission assembly are provided with a polymer layer, thereby avoiding NiTi having a cut pattern The tube will scratch the surface of the guide wire.

(5) Each electrode is controlled separately, and the working state of any one electrode is not affected by other electrodes. The medical staff can select one, some or all of the electrodes to release the adjustment energy according to actual needs. The device for regulating nerve provided by the invention is convenient to operate, can simultaneously adjust multiple nerve sites or selectively adjust certain nerve sites, thereby improving work efficiency and further improving treatment accuracy, and In the case of certain electrode failures, the medical staff can flexibly select the working electrode, and greatly submit the handling ability of the unexpected failure of the device to ensure the normal operation of the operation, which has important clinical significance.

In the present invention, the abbreviation used:

PTFE refers to polytetrafluoroethylene , ie Polytetrafluoroethylene ;

PE means polyethylene, ie Polyethylene;

FEP refers to a fluorinated ethylene propylene copolymer, namely Fluorinated ethylene propylene;

TPU refers to thermoplastic polyurethane elastomers, ie Thermoplastic polyurethanes;

PET refers to polyethylene terephthalate , ie Polyethylene terephthalate ;

Pebax refers to ATO Chimie, France The development of a polyether block phthalamide elastomer with a performance between synthetic rubber and thermoplastic polyurethane is known under the trade name Pebax.

For ease of illustration, in the present invention, 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 referred to as the 'distal', and the device or component is remote from the user (or handle) or near. One end of the nerve site that needs to be regulated is called the 'near end'.

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

DRAWINGS

Figure 1 is a schematic view showing the structure of human kidney and related tissues;

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

image 3 Is a schematic diagram of a component of a specific embodiment of a multi-electrode renal artery radiofrequency ablation catheter provided by the present invention, which shows a first shape of the bearing member;

Figure 4 is Figure 3 A schematic view of another state of the illustrated multi-electrode renal artery radiofrequency ablation catheter showing the second shape of the load bearing member;

Figure 5 is a cross-sectional view of a carrier member of a specific embodiment of a multi-electrode renal artery radiofrequency ablation catheter of the present invention (dissected from the electrode);

6 is a projection view of a cutting pattern of a load-bearing member of a specific embodiment of the multi-electrode renal artery radiofrequency ablation catheter of the present invention in a horizontal plane;

7 is an exploded view of a handle of a specific embodiment of a multi-electrode renal artery radiofrequency ablation catheter of the present invention;

Figure 8 is a partial cross-sectional view of a sheath of a specific embodiment of a multi-electrode renal artery radiofrequency ablation catheter of the present invention;

9 is a partial cross-sectional view of a sheath of another embodiment of a multi-electrode renal artery radiofrequency ablation catheter of the present invention.

detailed description

Figure 1~ Figure 4 A preferred embodiment of a multi-electrode renal artery radiofrequency ablation catheter and method of use thereof provided by the present invention is shown, for example, for modulating human renal nerves.

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

Figures 3 and 4 show the components of a multi-electrode renal artery radiofrequency ablation catheter in this embodiment. Figure 3~ Figure 4 As shown, the catheter includes an adjustment assembly 100 for modulating the nerve and a delivery member 201 for delivering the adjustment assembly 100 to the nerve. Adjustment component 100 An electrode 101 that delivers modulated energy to the renal nerves and a carrier member 102 for carrying the electrode 101 are included. The carrier member 102 has a first shape (see Fig. 3) and a second shape (see figure) 4), in the first shape, the adjustment assembly 100 is adapted to move in the blood vessel; in the second shape, the at least one electrode 101 is in a position to transfer the modulated energy to the renal nerve. In this embodiment, the carrier member 102 The delivery member 201 is integral with the proximal end of the carrier member 102 coupled to the distal end of the delivery member 201.

In this embodiment, the electrode 101 The way in which the modulated energy is delivered to the renal nerve site that needs to be modulated is: through the blood vessel into the human body, through the inner wall of the renal artery close to the nerve site. Therefore, the technical problem that needs to be solved is: to achieve the electrode 101 The nerve that acts against the inner wall of the blood vessel acts on the corresponding position, and the electrode 101 is required to easily move in the blood vessel without damaging the blood vessel wall.

The multi-electrode renal artery ablation catheter of the present embodiment further includes a sheath tube 301 and a guide wire passage 500 (see Fig. 5). Sheath 301 The jacket is disposed on the conveying member 201. The inner diameter of the sheath 301 is 1.2 to 1.45 mm, and the outer diameter is 1.3 to 1.55 mm. The sheath 301 can be along the conveying member 201. Sliding and jacketing or disengaging the adjustment assembly 100. The guidewire channel 500 is disposed inside the multi-electrode renal artery ablation catheter of the present embodiment and extends through the entire multi-electrode renal artery ablation catheter, i.e., on the carrier member 102. The interior of the inner and delivery member 201 has a portion of the guidewire channel 500. Guide wire channel 500 For axial movement of the guidewire within the multi-electrode renal artery ablation catheter along the multi-electrode renal artery ablation catheter. The guide wire passage 500 has an opening at both the proximal end and the distal end (see Fig. 1). Guide wire channel 500 The distal opening 106 is used to guide the guidewire into the interior of the multi-electrode renal artery ablation catheter, specifically into the interior of the carrier member 102, the guidewire channel 500 The proximal opening is used to guide the guidewire out of the multi-electrode renal artery ablation catheter.

The distal end of the carrier member 102 is provided with a protective member 105 for reducing or avoiding damage to the vessel wall. Protective member 105 One of the functions is to reduce or avoid damage to the blood vessel wall. When it touches the blood vessel wall, it is soft enough and can rebound quickly without causing loss to the blood vessel; protective member 105 Another function is to guide the entire catheter device. When encountering the bend of the blood vessel, it can bend according to the bending degree of the blood vessel, thereby guiding the entire catheter to smoothly pass through the bend of the blood vessel. In this embodiment, the protection component 105 is a soft head made of rubber, silicone or thermoplastic elastomer. The soft head has an opening for guiding the guide wire into the carrier member, which is the opening 106 of the distal end of the guidewire channel 500.

The carrier member 102 and the conveying member 201 are both tubular, and are polymer layers, NiTi, in order from the inside to the outside in the radial direction of the tubular shape. Tube, inner insulating layer and outer insulating layer. Figure 5 shows a cross-sectional view of the carrier member 102, which is cut away from the electrode 101, as seen in Figure 5, along the carrier member 102. The radial direction from the inside to the outside is a polymer layer 504, a NiTi tube 503, an inner insulating layer 501, and an outer insulating layer 502. The polymer layer 504 of the carrier member 102 and the conveying member The polymer layer of 201 (not shown) is integrated and has a diameter of 0.40 to 0.55 mm and a thickness of 0.025 to 0.1 mm, both of which are formed of a polymer material, and the polymer material may be PET, FEP, Pebax, PE or PTFE.

The carrier member 102 is irritating and pre-processed to have a second shape for the carrier member 102 to be When the second shape has a sufficiently large radial supporting force, the surface of the NiTi tube 503 of the bearing member 102 is cut by laser cutting to form a cutting pattern. In this embodiment, the cutting pattern is a spiral groove, Fig. 6 A projected view of the cut pattern in the horizontal plane is shown, with the load bearing member 102 in the first shape. The projection of the spiral groove in the horizontal plane comprises a plurality of linear grooves or a plurality of approximate linear grooves 603, A plurality of linear grooves are located at the distal end of the carrier member 102, and the plurality of linear grooves include a plurality of first linear grooves 601 and a plurality of second linear grooves 602. Two adjacent first linear grooves 601 The pitches are the same, and the plurality of first linear grooves 601 are parallel to each other; the spacing of each adjacent two second linear grooves 602 is the same, and the plurality of second linear grooves 602 are parallel to each other. Multiple approximate linear grooves 603 Located at the proximal end of the carrier member 102, from the distal end to the proximal end of the carrier member 102, the spacing between adjacent two approximately linear grooves 603 is gradually increased, and a plurality of approximate linear grooves 603 They are not parallel to each other. The angle between the first linear groove 601 and the axial direction of the bearing member 102 is 75° to 85°, and the angle between the second linear groove 602 and the axial direction of the bearing member 102 is 65°~75°, the angle between the approximate linear groove 603 and the axial direction of the bearing member 102 is 50°~65°, where the axial direction refers to the bearing member when the bearing member 102 is in the first shape. The proximal end of 102 points in the direction of the distal end of carrier member 102.

In this embodiment, the inner insulating layer 501 of the carrier member 102 and the inner insulating layer (not shown) of the conveying member 201 are both PET. The heat-shrinkable tube has a thickness of 0.012 to 0.05 mm after heat shrinkage. The outer insulating layer 502 of the bearing member 102 is a TPU tube or a Pebax tube with a diameter of 0.9 to 1.2 mm. The thickness is 0.05~0.15mm. The outer insulating layer (not shown) of the conveying member 201 is a PET or FEP heat-shrinkable tube, and the thickness after heat shrinking is 0.012~0.1 mm. .

In this embodiment, the electrode 101 is annular and fits over the outer insulating layer 502 of the carrier member 102. The outer surface. Thus, when the carrier member 102 is in the second shape (inside the renal artery), the electrode 101 on the carrier member 102 It is in contact with the inner wall of the renal artery (near the renal nerve) so that adjustment work can be performed. In order to securely mount the electrode 101 on the outer insulating layer 502 of the carrier member 102 The outer surface is minimized and the damage to the vessel wall is minimized, and the electrode 101 can be bonded to the outer insulating layer 502 of the carrier member 102 using glue. This type of glue can be UV Curing adhesive, epoxy resin or a mixture thereof has the biocompatibility for medical use and a certain adhesion to metal alloys and polymer materials. Additionally, an outer insulating layer 502 of the carrier member 102 A wire 505 for providing the electrode 101 with the adjustment energy and monitoring the temperature and impedance during the ablation is provided between the inner insulating layer 501 and the wire 505 at the conveying member 201. The outer insulating layer and the inner insulating layer extend, and the wires 505 in the carrier member 102 and the wires 505 in the conveying member 201 are integrated. Wire 505 passes through the outer insulation of carrier member 102 The inner surface of the 502 and the electrode 101 is welded by soldering or laser welding. The outer insulating layer 502 of the carrier member 102 has an opening (not shown) at a position where the electrode 101 is attached. A wire 505 connected to an energy generating device (e.g., a radio frequency meter) is welded to the inner surface of the electrode 101 through the opening. By placing the wire 505 on the outer insulating layer 502 It is possible to avoid the technical disadvantage that the wire must be placed on the outer surface of the conveying member for the purpose of insulation, causing the outer surface of the conveying member to be uneven, thereby avoiding many problems caused by unevenness of the outer surface of the conveying member. When having multiple electrodes At 101, it is necessary to provide a plurality of wires 505 that respectively connect the plurality of electrodes 101 to the energy generating device. Each of the electrodes 101 operates independently and has a separate wire 505, respectively. Whether an electrode releases the adjustment energy is independent of other electrodes; only one or a part of the electrodes can transmit the adjustment energy, or all the electrodes can work at the same time to transmit the adjustment energy; the state of whether each electrode transmits the adjustment energy is independent of each other. Elements for measuring temperature (e.g., thermocouples) and corresponding wires may also be disposed on the carrier member 102. The arrangement of the wires and thermocouples is conventional in the art and will not be described in detail herein.

In this embodiment, the carrier member 102 The first shape is straight or nearly straight, and may also be elongated or fibrous or filiform. The cross section of the strip is preferably circular or nearly circular, and the widest part of the cross section is smaller than the inside of the blood vessel. diameter. Thus, in the first shape, when the adjustment component 100 The adjustment assembly 100 does not damage the vessel wall as it moves through the blood vessel. When it is necessary to adjust the nerves on the renal artery, since the inner diameter of the human renal artery is generally 4-7 mm, the adjustment component 100 The maximum dimension in the radial direction of the renal artery is not more than 4 mm, preferably 1-2 mm. It can satisfy the convenient movement in the blood vessel, has sufficient rigidity and is easy to manufacture, and can reduce the size of the wound of the patient. As a variation of this embodiment, the first shape may also allow for a certain bending or wavy bending, and the cross section may be other shapes as long as the surface is smooth and can be easily moved within the blood vessel without damaging the blood vessel wall. can.

In this embodiment, the second shape of the carrier member 102 is entirely spiral or approximately spiral, and the bearing member 102 is radially in the blood vessel. The widest point is larger than the first shape so that the loaded electrode 101 is brought close to or in contact with the vessel wall, thereby being close to the renal nerve.

Considering that the blood vessel has a certain elasticity, the diameter of the spiral or approximate spiral of the bearing member 102 is set to 4 to 12 mm, and the pitch is 3~10 mm. For individuals with a small inner diameter of the renal artery, for example, an inner diameter of about 4 mm, the diameter of the spiral or approximately spiral of the bearing member 102 can be set to 5 to 6 mm. Left and right; for individuals with a large inner diameter of the renal artery, for example, an inner diameter of about 7 mm, the diameter of the spiral or approximate spiral can be set to about 8 to 9 mm.

The second shape of the carrier member 102 can also be other shapes, such as a random shape having a smooth curvature, as long as the carrier member 102 When in the blood vessel, the electrode 101 is in a position to contact the blood vessel wall.

The multi-electrode renal artery radiofrequency ablation catheter of the present embodiment causes the carrier member 102 by the interaction of the sheath 301 and the guide wire. Switching between the first shape and the second shape, i.e., when the sheath 301 slides along the delivery member 201 and overlies the adjustment assembly 100, while guiding the guidewire from the distal end of the guidewire channel 500 106 Upon insertion of the guidewire channel 500 into the interior of the carrier member 102, the carrier member 102 is switched from the second shape to the first shape; when the guidewire is from the proximal end of the guidewire channel 500. The carrier member 102 is worn out and withdrawn from the interior of the carrier member 102 while the sheath tube 301 slides along the delivery member 201 and disengages from the adjustment assembly 100. Switching from the first shape to the second shape.

In other embodiments, for the case where the radial supporting force of the bearing member 102 is small, the sheath 301 may be passed through. Or the separate action of the guide wire effects the switching of the carrier member 102 between the first shape and the second shape. The separate function of the sheath 301 means that the sheath 301 slides along the conveying member 201 and is sheathed to the adjustment assembly. At 100 o'clock, the carrier member 102 is switched from the second shape to the first shape; when the sheath 301 slides along the transport member 201 and disengages from the adjustment assembly 100, the carrier member 102 Switching from the first shape to the second shape. The separate action of the guidewire means that the guidewire enters the carrier member 102 as it is inserted into the guidewire channel 500 from the opening 106 from the distal end of the guidewire channel 500. The carrier member 102 is switched from the second shape to the first shape; when the guide wire passes through the opening 107 at the proximal end of the guide wire passage 500 and is pulled away from the inside of the carrier member 102, the carrier member 102 switches from the first shape to the second shape.

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

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

(2) The sheath 301 is sheathed to the adjustment assembly 100, and then the guide wire is inserted from the first hole into the carrier member 102. And passing through the second hole, so that the bearing member 102 is changed from the pre-formed second shape to the first shape to facilitate movement in the blood vessel;

(3) moving the multi-electrode renal artery radiofrequency ablation catheter to the renal sympathetic nerve on the human renal artery;

(4) pulling the guide wire away from the carrier member 102 and disengaging the sheath 301 from the adjustment assembly 100, the carrier member 102 From the first shape to the second shape, at this time, the electrode 101 on the carrier member 102 abuts against the inner wall of the blood vessel to act on the nerve at the corresponding position, releasing energy. Certain energy acts on the nerve site to regulate the nerve site (eg, reduce or eliminate activation of the sympathetic nerve);

(5) The sheath 301 is sheathed to the adjustment assembly 100, and then the guide wire is pushed into the carrier member 102, the carrier member 102 is again changed from the second shape to the first shape;

(6) Remove the multi-electrode renal artery radiofrequency ablation catheter from the body.

Electrode 101 This can be achieved by transferring heat to the nerve site. For example, heat transfer heating mechanisms for neuromodulation may include thermal ablation and non-ablative thermal changes or damage, for example, the temperature of the target nerve fibers may be raised above a desired threshold to achieve non-ablative thermal changes, or more High temperatures to achieve thermal changes in ablation. For example, the target temperature can be around 37 ° C - 45 ° C (for the thermal temperature of non-thermal ablation), or the target temperature may be about 45 ° C or higher for the thermal change of ablation.

Electrode 101 can also accomplish this by delivering cooling to the nerve site. For example, reducing the temperature of the target nerve fiber to about 20 Below °C to achieve non-freezing thermal changes, or to lower the temperature of the target nerve fibers to below about 0 °C to achieve the thermal change of freezing.

Electrode 101 It can also be achieved by applying an energy field to the target nerve fibers. The energy field may include: electromagnetic energy, radio frequency, ultrasonic waves (including high intensity focused ultrasound), microwave, light energy (including laser, infrared, and near infrared). For example, thermally induced neuromodulation can be achieved by delivering a pulsed or continuous thermal energy field to the target nerve fibers. Among them, a more preferred energy mode is a pulsed RF electric field or other types of pulsed thermal energy. Pulsed RF electric fields or other types of pulsed thermal energy can contribute to greater heat levels, longer total duration, and / or better controlled intravascular renal neuromodulation therapy.

Regardless of the energy source for the purpose of regulating the nerve, when the user works with the catheter provided by the present invention, the electrode 101 Need to generate this energy (such as a radio frequency meter) or to make an electrode 101 The device that generates the energy itself is electrically connected. These devices and the connection of the electrodes to these devices are prior art well known to those skilled in the art (for example, an interface for connecting these devices is provided in the device of the present invention, which enables plug and play when used), and is no longer here. Detailed description.

In this embodiment, the number of the electrodes 101 is four. Adjacent electrodes when the carrier member 102 is in the second shape (helical) 101 The distance D in the axial direction of the blood vessel is 4~12 mm. In general, when performing renal nerve ablation surgery, 3-8 of the renal nerves One site is ablated. Therefore, when working with the apparatus of this embodiment, the positioning of the primary adjustment assembly 100 (contacting the electrode 101 to the inner wall of the blood vessel) can be completed. Ablation of the sites, and the entire ablation procedure requires only two adjustments to the positioning of the assembly 100. As a variation of this embodiment, the number of electrodes 101 can also be set to 2~6. However, if the number is large, the production cost of the entire device will be increased; if the number is small, the work efficiency of the ablation operation can be reduced. Electrode 101 The material may be a metal or metal alloy that is more biocompatible or relatively stable, such as a platinum group metal (such as a platinum rhodium alloy).

The guide wire of this embodiment is a wire made of a NiTi alloy.

The multi-electrode renal artery radiofrequency ablation catheter of the present embodiment further includes a handle 401 for gripping, a distal end of the handle 401 and a delivery member The proximal connection of 201 (see Figure 3). The wire 505 is connected to the handle 401 after extending within the carrier member 102 and the conveying member 201. Handle 401 The connecting cable to the external energy generator is provided as a separate unit or a separate two parts connected by a switching port. The movement of the sheath 301 of the present embodiment is controlled by a control mechanism 7 provided in the handle 401, see 3 and FIG. 7, the control mechanism 7 includes a tip 701, a tooth block 702 and a gear 703. The end 701 is located at the distal end of the handle 401 and is coupled to the sheath 301. The tooth block 702 Connected to the end 701, the gear 703 is matched with the tooth block 702; the rotating gear 703 enables the tooth block 702 to push and pull the end 701 so that the end 701 pushes and pulls the sheath 301 Move along the conveying member 201.

The material of the sheath 301 is a polymer material such as Pebax or TPU, which is slightly harder than the material of the bearing member 102 and has a hardness of 50A-50D. The sheath 301 includes an inner layer 302 and an outer layer 303. As shown in FIG. 8, the inner layer 302 is made of PTFE, has a wall thickness of 0.015-0.5 mm, and has a small coefficient of friction. When the sheath 301 slides relative to the bearing member 102, It mainly plays a smoothing role. The outer layer 303 is made of Pebax or TPU and may contain 20 wt% to 40 wt% BaSO ₄ or 10 wt% to 30 wt% BiOCl.

The remainder of the outer layer has a braided mesh tube, except for the outer layer 1 to 5 mm from the farthest end of the sheath 301, as shown in Fig. 9. As shown, the braided mesh tube includes a first braided wire segment 313, a second braided wire segment 323, and a third braided wire segment 333; a first braided wire segment 313, a second braided wire segment 323, and a third braided wire segment 333 The braided wire is a stainless steel wire or a Ni-Ti wire. a first braided wire segment 313, a second braided wire segment 323 and a third braided wire segment 333 Different hardnesses can be achieved by the same weaving method and the different hardness of Pebax in the outer layer in which they are located, or by the same Pebax hardness and different weaving methods. In this embodiment, The braided wires of the first braided wire segment 313, the second braided wire segment 323 and the third braided wire segment 333 are made in a different manner, so that the sheath 301 is close to the distal end of the 401 handle 10-20 cm. The hardness of the portion is greater than the hardness of the other portions of the sheath 301. The hardness of the distal end of the sheath 301 has a transition from small to large, facilitating the multi-electrode renal artery ablation catheter of the present embodiment to enter a predetermined position of the renal artery.

The above has described in detail the preferred embodiments of the invention. It should be understood that one of ordinary skill in the art can use the present invention without creative labor. The idea has been changed and changed. Therefore, those skilled in the art according to the present invention The technical solution that can be obtained by logic analysis, reasoning or limited experiment on the basis of the prior art is within the scope of protection determined by the claims.

Claims (51)

1. A multi-electrode renal artery ablation catheter comprising an adjustment assembly for modulating a nerve and a delivery member for delivering the adjustment assembly to a location of the nerve;

   The adjustment assembly includes a plurality of electrodes for delivering modulated energy to the nerve and a carrier member for carrying a plurality of the electrodes;

   The carrier member has a first shape and a second shape, the adjustment assembly being adapted to move within a blood vessel; and in the second shape, at least one of the electrodes is adapted to adjust the The location at which energy is delivered to the nerve;

   Characterizing in that the multi-electrode renal artery ablation catheter further comprises a sheath; the sheath is sheathed to the delivery member, the sheath being slidable along the delivery member and sheathed or detached from the adjustment assembly;

   The interior of the multi-electrode renal artery ablation catheter is provided with a guidewire channel extending throughout the multi-electrode renal artery ablation catheter for guiding a guidewire at the multi-electrode renal artery ablation The interior of the catheter moves axially along the multi-electrode renal artery ablation catheter;

   The multi-electrode renal artery ablation catheter is configured to enable the carrier member to be in the described manner by the separate action of the sheath or the guidewire or by the interaction of the sheath and the guidewire Switching between the first shape and the second shape.
2. The multi-electrode renal artery ablation catheter of claim 1 wherein the separate function of the sheath means that the sheath is slidable along the delivery member and over the adjustment assembly. The component is switched from the second shape to the first shape; the carrier member is switched from the first shape to the second when the sheath slides along the transport member and disengages from the adjustment assembly shape.
3. The multi-electrode renal artery ablation catheter of claim 1 wherein said proximal and distal ends of said guidewire channel have openings.
4. A multi-electrode renal artery ablation catheter according to claim 3, wherein the separate action of the guidewire means that the guidewire is inserted from the opening of the distal end of the guidewire channel The guide member is switched from the second shape to the first shape when the guide wire passage enters the interior of the carrier member; when the guide wire is open from the proximal end of the guide wire passage The carrier member is switched from the first shape to the second shape when it is pulled out and pulled away from the interior of the carrier member.
5. A multi-electrode renal artery ablation catheter according to claim 3, wherein said sheath and said guide wire cooperate to mean that said sheath slides along said delivery member and is sheathed to said adjustment The assembly, when the guide wire is inserted into the guide wire passage from the opening of the distal end of the guide wire passage into the interior of the carrier member, the carrier member is switched from the second shape to the a first shape; the guide wire exits from the proximal end opening of the guidewire channel and is withdrawn from the carrier member while the sheath slides along the delivery member and disengages from the adjustment In the component, the carrier member is switched from the first shape to the second shape.
6. The multi-electrode renal artery ablation catheter according to claim 1, wherein the carrier member and the conveying member are both tubular, and the polymer layer and the NiTi tube are sequentially arranged from the inside to the outside in the radial direction of the tubular shape. , inner insulating layer and outer insulating layer.
7. The multi-electrode renal artery ablation catheter according to claim 6, wherein the polymer layer of the bearing member and the polymer layer of the conveying member have a diameter of 0.40 to 0.55 mm and a thickness of 0.025 to 0.1. Mm.
8. The multi-electrode renal artery ablation catheter according to claim 6, wherein the polymer layer of the carrier member and the polymer layer of the transport member are integrated and formed of a polymer material.
9. The multi-electrode renal artery ablation catheter of claim 8 wherein said polymeric material is PET, FEP, Pebax, PE or PTFE.
10. A multi-electrode renal artery ablation catheter according to claim 6, wherein a surface of said NiTi tube of said carrier member has a cut pattern formed by laser cutting on a surface of said NiTi tube of said carrier member Spiral groove.
11. A multi-electrode renal artery ablation catheter according to claim 10, wherein when said carrier member is in said first shape, said projection of said spiral groove in a horizontal plane comprises a plurality of linear grooves and a plurality of approximate straight lines groove.
12. The multi-electrode renal artery ablation catheter of claim 11 wherein said plurality of linear grooves are located at a distal end of said carrier member, said plurality of linear grooves comprising a plurality of first linear grooves and a plurality The second linear groove.
13. A multi-electrode renal artery ablation catheter according to claim 12, wherein each of said two first linear grooves has the same pitch, and said plurality of said first linear grooves are parallel to each other.
14. A multi-electrode renal artery ablation catheter according to claim 12, wherein the spacing between each of the two adjacent second linear grooves is the same, and the plurality of said second linear grooves are parallel to each other.
15. The multi-electrode renal artery ablation catheter according to claim 12, wherein an angle between the first linear groove and the axial direction of the bearing member is 75° to 85°, and the second linear groove is The axial angle of the bearing member is 65°~75°, and the angle between the approximate linear groove and the axial direction of the bearing member is 50°~65°, and the axial direction refers to when the bearing When the component is in the first shape, the direction from the proximal end of the carrier member to the distal end of the carrier member.
16. The multi-electrode renal artery ablation catheter of claim 11 wherein said plurality of approximately linear grooves are located at a proximal end of said carrier member, from a distal end to a proximal end of said carrier member, adjacent to two The spacing between the approximate linear grooves is gradually increased, and the plurality of the approximate linear grooves are not parallel to each other.
17. The multi-electrode renal artery ablation catheter according to claim 6, wherein the inner insulating layer of the bearing member and the inner insulating layer of the conveying member are both PET heat-shrinkable tubes, and the thickness after heat shrinking is 0.012~ 0.05 Mm.
18. The multi-electrode renal artery ablation catheter according to claim 6, wherein the outer insulating layer of the bearing member is a TPU tube or a Pebax tube having a diameter of 0.9 to 1.2 mm and a thickness of 0.05 to 0.15 mm.
19. The multi-electrode renal artery ablation catheter according to claim 6, wherein the outer insulating layer of the conveying member is a PET or FEP heat-shrinkable tube, and the thickness after heat shrinking is 0.012 to 0.1 mm.
20. A multi-electrode renal artery ablation catheter according to claim 6 wherein said electrode is sleeved over the outer insulating layer of said carrier member and is reinforced by an adhesive.
21. A multi-electrode renal artery ablation catheter according to claim 20, wherein the binder is a UV curable gel or an epoxy gel.
22. The multi-electrode renal artery ablation catheter of claim 20 wherein a plurality of said electrodes individually control the release of energy.
23. A multi-electrode renal artery ablation catheter according to claim 20 wherein a plurality of said electrodes simultaneously control the release of energy.
24. A multi-electrode renal artery ablation catheter according to claim 22 or 23, wherein the inner surface of each of said electrodes is connected to a wire for providing said adjustment energy to said electrode and for monitoring ablation Temperature and impedance.
25. A multi-electrode renal artery ablation catheter according to claim 24, wherein said wire is disposed between said outer insulating layer and said inner insulating layer of said carrier member and within said outer insulating layer of said conveying member Extending between the insulating layers.
26. A multi-electrode renal artery ablation catheter according to claim 25, wherein said wire passes through an outer insulating layer of said carrier member and is welded to the inner surface of said electrode by soldering or laser welding.
27. The multi-electrode renal artery ablation catheter of claim 1 wherein said first shape of said carrier member is straight or nearly straight.
28. The multi-electrode renal artery ablation catheter of claim 1 wherein said second shape of said carrier member is helical or approximately helical.
29. A multi-electrode renal artery ablation catheter according to claim 25, wherein said spiral or said approximate spiral has a diameter of 4 to 12 mm and a pitch of 3 to 10 Mm.
30. The multi-electrode renal artery ablation catheter of claim 1 wherein said carrier member is turbulent and pretreated to have said second shape.
31. The multi-electrode renal artery ablation catheter of claim 1 wherein said electrode has a circular cross section.
32. A multi-electrode renal artery ablation catheter according to claim 1 wherein said number of electrodes is from 2 to 6, and when said carrier member is in said first shape, between said adjacent electrodes The distance is 4~12 Mm.
33. The multi-electrode renal artery ablation catheter of claim 1 wherein said electrode is made of platinum rhodium alloy or gold.
34. A multi-electrode renal artery ablation catheter according to claim 1 wherein said multi-electrode renal artery ablation catheter further comprises a handle for gripping, the distal end of said handle being coupled to the proximal end of said delivery member .
35. A multi-electrode renal artery ablation catheter according to claim 34, wherein a control mechanism is provided in said handle for controlling movement of said sheath.
36. A multi-electrode renal artery ablation catheter according to claim 35, wherein said control mechanism includes a tip, a block and a gear, said tip being located at a distal end of said handle and coupled to said sheath The tooth block is coupled to the end, the gear is mated with the tooth block; rotating the gear enables the tooth block to push and pull the end, such that the end pushes and pulls the sheath along the The conveying member moves.
37. The multi-electrode renal artery ablation catheter of claim 1 wherein said carrier member and said delivery member are unitary.
38. The multi-electrode renal artery ablation catheter of claim 1 wherein the proximal end of the carrier member is coupled to the distal end of the delivery member.
39. The multi-electrode renal artery ablation catheter of claim 1 wherein said sheath has an inner diameter of 1.2 to 1.45 mm and an outer diameter of 1.3 to 1.55. Mm.
40. The multi-electrode renal artery ablation catheter of claim 1 wherein said sheath comprises an inner layer and an outer layer.
41. The multi-electrode renal artery ablation catheter according to claim 40, wherein the inner layer is made of PTFE and has a thickness of 0.015 to 0.5. Mm.
42. A multi-electrode renal artery ablation catheter according to claim 40, wherein said outer layer is Pebax or TPU, and said Pebax or TPU contains 20 Wt% ~ 40wt% BaSO4 or 10 wt% ~ 30 wt% BiOCl.
43. A multi-electrode renal artery ablation catheter according to claim 40, wherein said outer layer is at a distal end of said sheath from 1 to 5 Outside the portion of mm, the remainder of the outer layer has a braided mesh tube.
44. A multi-electrode renal artery ablation catheter according to claim 43 wherein said braided mesh tube comprises a first braided wire segment, a second braided wire segment and a third braided wire segment.
45. The multi-electrode renal artery ablation catheter of claim 44, wherein the braided wire of the first braided wire segment, the second braided wire segment, and the third braided wire segment is a stainless steel wire or a NiTi wire .
46. A multi-electrode renal artery ablation catheter according to claim 44, wherein said first braided wire segment, said second braided wire segment and said third braided wire segment are braided in a different manner, such that The sheath is near the distal end of the handle 10~20 The hardness of the portion of cm is greater than the hardness of the other portions of the sheath.
47. 40. The multi-electrode renal artery ablation catheter of claim 43 wherein the distal end of the sheath has a hardness transition from small to large to facilitate entry of the multi-electrode renal artery ablation catheter into a predetermined location of the renal artery.
48. The multi-electrode renal artery 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.
49. A multi-electrode renal artery ablation catheter according to claim 48, wherein said protective member is a soft head.
50. A multi-electrode renal artery ablation catheter according to claim 49, wherein said soft head has an opening for said guide wire to be inserted into said carrier member, said opening of said soft head being said guide wire channel The opening at the distal end.
51. A multi-electrode renal artery ablation catheter according to claim 48, wherein said protective member is made of rubber, silicone or a thermoplastic elastomer material.