CN107028651B - Multi-electrode renal artery radio frequency ablation catheter - Google Patents
Multi-electrode renal artery radio frequency ablation catheter Download PDFInfo
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- CN107028651B CN107028651B CN201610290782.6A CN201610290782A CN107028651B CN 107028651 B CN107028651 B CN 107028651B CN 201610290782 A CN201610290782 A CN 201610290782A CN 107028651 B CN107028651 B CN 107028651B
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Abstract
The invention discloses a multi-electrode renal artery ablation catheter which comprises a regulating component for regulating nerves, a conveying component for conveying the regulating component to the positions of the nerves and a sheath tube. The modulation assembly includes a plurality of electrodes for delivering modulation energy to the nerve and a carrier member for carrying the plurality of electrodes; the carrier member has a first shape in which the adjustment assembly is adapted to move in the blood vessel and a second shape; in the second shape, at least one electrode is in a position suitable for delivering modulation energy to the nerve. The sheath is sleeved on the conveying component, can slide along the conveying component and is sleeved on or separated from the adjusting component. The multi-electrode renal artery ablation catheter is internally provided with a guide wire channel, and the guide wire channel penetrates through the whole multi-electrode renal artery ablation catheter. The carrier member can be switched between the first shape and the second shape by a separate action of the sheath or the guide wire or by a combined action of the sheath and the guide wire.
Description
Technical Field
The invention relates to electrosurgery, in particular to a multi-electrode 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.
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 current devices have drawbacks such as inconvenient operation, high manufacturing cost or low efficiency, etc., such as the electrode bearing member failing to provide a sufficient supporting force, the electrode bearing member having a large frictional force at the cutting site, etc.
Accordingly, the present invention provides a novel multi-electrode renal artery radiofrequency ablation catheter.
Disclosure of Invention
In view of the above-mentioned drawbacks of the prior art, the present invention is to provide a catheter device for adjusting renal nerves to treat related diseases, which is convenient to operate, low in manufacturing cost and high in efficiency.
To achieve the above object, the present invention provides a multi-electrode renal artery ablation catheter,
Comprising a modulation assembly for modulating a nerve and a delivery member for delivering the modulation assembly to a location of the nerve;
The modulation assembly comprises a plurality of electrodes for delivering modulation energy to the nerve and a carrier member for carrying a plurality of the electrodes;
The carrier member has a first shape in which the adjustment assembly is adapted to move in a blood vessel and a second shape; in the second shape, at least one of the electrodes is in a position suitable for delivering the modulation energy to the nerve;
The multi-electrode renal artery ablation catheter is characterized by further comprising a sheath; the sheath tube is sleeved on the conveying component, and the sheath tube can slide along the conveying component and is sleeved on or separated from the adjusting component;
A guide wire channel is arranged in the multi-electrode renal artery ablation catheter, the guide wire channel penetrates through the whole multi-electrode renal artery ablation catheter, and the guide wire channel is used for guiding a guide wire to move in the multi-electrode renal artery ablation catheter along the axial direction of the multi-electrode renal artery ablation catheter;
The multi-electrode renal artery ablation catheter is configured to: the carrier member is switchable between the first shape and the second shape by a separate action of the sheath or the guide wire or by a combined action of the sheath and the guide wire.
Further, the sheath alone means that the carrier member is switched from the second shape to the first shape when the sheath is slid along the delivery member and over the adjustment assembly; the carrier member switches from the first shape to the second shape when the sheath slides along the delivery member and disengages the adjustment assembly.
Further, both the proximal and distal ends of the guidewire channel have openings.
Further, the sole action of the guide wire means that the carrier member is switched from the second shape to the first shape when the guide wire is inserted into the guide wire channel from the opening of the distal end of the guide wire channel into the interior of the carrier member; the carrier member switches from the first shape to the second shape when the guide wire is threaded out of the opening of the proximal end of the guide wire channel and is withdrawn from the interior of the carrier member.
Further, the coaction of the sheath and the guidewire means that the carrier member is switched from the second shape to the first shape when the sheath is slid along the delivery member and over the adjustment assembly while the guidewire is inserted into the guidewire channel from the distal opening of the guidewire channel into the interior of the carrier member; the carrier member is switched from the first shape to the second shape when the guide wire is threaded out of the opening of the proximal end of the guide wire channel and withdrawn from the carrier member while the sheath is slid along the delivery member and out of the adjustment assembly.
Further, the bearing component and the conveying component are tubular, and a high polymer layer, a NiTi pipe, an inner insulating layer and an outer insulating layer are sequentially arranged along the radial direction of the tubular shape from inside to outside.
Further, the diameters of the polymer layer of the bearing component and the polymer layer of the conveying component are 0.40-0.55 mm, and the thicknesses are 0.025-0.1 mm.
Further, the polymer layer of the carrying member and the polymer layer of the conveying 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, which is a spiral groove formed on the surface of the NiTi tube of the bearing member by laser cutting.
Further, when the load bearing member is in the first shape, the projection of the spiral groove on a horizontal plane includes a plurality of straight grooves and a plurality of approximate straight grooves.
Further, the plurality of linear grooves is located at a distal end of the carrier member, the plurality of linear grooves including a plurality of first linear grooves and a plurality of second linear grooves.
Further, the distance between every two adjacent first linear grooves is the same, and a plurality of first linear grooves are parallel to each other.
Further, the distance between every two adjacent second linear grooves is the same, and a plurality of the second linear grooves are mutually parallel.
Further, an included angle between the first linear groove and the axial direction of the bearing component is 75-85 degrees, an included angle between the second linear groove and the axial direction of the bearing component is 65-75 degrees, an included angle between the approximate linear groove and the axial direction of the bearing component is 50-65 degrees, and the axial direction refers to a direction from the proximal end of the bearing component to the distal end of the bearing component when the bearing component is in the first shape.
Further, the plurality of approximately linear grooves are located at the proximal end of the bearing component, the distance between every two adjacent approximately linear grooves is gradually increased from the distal end to the proximal end of the bearing component, and the plurality of approximately linear grooves are not parallel to each other.
Further, the inner insulating layer of the bearing component and the inner insulating layer of the conveying component are PET heat shrinkage pipes, and the thickness after heat shrinkage is 0.012-0.05 mm.
Further, the outer insulating layer of the bearing component is a TPU pipe or a Pebax pipe, the diameter is 0.9-1.2 mm, and the thickness is 0.05-0.15 mm.
Further, the outer insulating layer of the conveying component is a PET or FEP heat shrinkage pipe, and the thickness of the heat shrinkage pipe is 0.012-0.1 mm.
Further, the electrode is sleeved outside the outer insulating layer of the bearing part and is reinforced and fixed through an adhesive.
Further, the adhesive is a UV curable glue or an epoxy glue.
Further, a plurality of the electrodes individually control the release of energy.
Further, a plurality of the electrodes simultaneously control the release of energy.
Further, the inner surface of each of the electrodes is connected to a lead for providing the adjustment energy to the electrode 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 delivery member.
Further, the lead wires are soldered or laser-welded to the inner surface of the electrode through the outer insulating layer of the carrier member.
Further, the first shape of the load bearing member is straight or approximately straight.
Further, the second shape of the load bearing member is a spiral or near-spiral.
Further, the diameter of the spiral or the approximate spiral is 4-12 mm, and the pitch is 3-10 mm.
Further, the load bearing member is perturbed and pre-treated to have the first shape.
Further, the cross section of the electrode is annular.
Further, the number of the electrodes is 2 to 6, and when the bearing member is in the second shape, the distance between the adjacent electrodes is 4 to 12mm.
Further, the electrode is made of platinum iridium alloy or gold.
Further, the multi-electrode renal artery ablation catheter further comprises a handle for grasping, the handle is connected with the proximal end of the delivery member, and the distal end of the handle is connected with the proximal end of the delivery member.
Further, a control mechanism is arranged in the handle and used for controlling the movement of the sheath tube.
Further, the control mechanism comprises a tip, a tooth block and a gear, wherein the tip is positioned at the distal end of the handle and is connected with the sheath, the tooth block is connected with the tip, and the gear is matched with the tooth block; rotating the gear can cause the tooth block to push and pull the tip, so that the tip pushes and pulls the sheath to move along the delivery component.
Further, the carrier member and the delivery member are integral.
Further, the proximal end of the carrier member is connected to the distal end of the delivery member.
Further, the sheath has an inner diameter of 1.2-1.45 mm and an outer diameter of 1.3-1.55 mm.
Further, the sheath includes an inner layer and an outer layer.
Further, the inner layer is made of PTFE, and the wall thickness is 0.015-0.5 mm.
Further, the outer layer is Pebax or TPU, and the Pebax or TPU contains 20-40 wt% of BaSO 4 or 10-30 wt% of BiOCl.
Further, the rest of the outer layer has a woven mesh tube except for a portion of the outer layer 1-5 mm from the most distal end of the sheath.
Further, the woven mesh tube includes a first woven wire segment, a second woven wire segment, and a third woven wire segment.
Further, the braiding wires of the first braiding wire section, the second braiding wire section and the third braiding wire section are stainless steel wires or NiTi wires.
Further, the braiding modes of the braiding wires of the first braiding wire section, the second braiding wire section and the third braiding wire section are different, so that the hardness of the part of the sheath tube, which is close to the distal end of the handle and is 10-20 cm, is higher than that of other parts of the sheath tube.
Further, the hardness of the distal end of the sheath has a transition from small to large to facilitate 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 vessel wall.
Further, the protection component is a soft head.
Further, the soft head has an opening for insertion of the guide wire into the carrier member, the opening of the soft head being an opening at the distal end of the guide wire channel.
Further, the protective member is made of rubber, silicone or thermoplastic elastomer material.
Further, the nerve is a renal sympathetic nerve located on a human renal artery, and the "location near the nerve" refers to being located in the renal artery.
Further, modulation refers to removal or reduction of activation of the nerve by means of injury 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 term "adapted to move in a blood vessel" means that the regulatory element does not damage the wall of the blood vessel when the regulatory element moves in the blood vessel.
Further, the term "adapted to move within 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 term "adapted to move in a blood vessel" means that the maximum dimension of the adjustment assembly in the radial direction of the blood vessel is not more than 3mm.
Further, the term "adapted to move within a blood vessel" means to easily pass through a curved segment of the blood vessel.
Further, the "position suitable for delivering the modulation energy to the renal nerve" refers to a position where at least one electrode is in contact with a vessel wall when the modulation member is in the vessel.
Further, the "location adapted to deliver the modulation energy to the renal nerve" means that the maximum dimension of the modulation assembly in the radial direction of the blood vessel is 4-12mm, with at least one electrode at the maximum dimension.
Compared with the existing catheter device, the multi-electrode renal artery radiofrequency ablation catheter has the following advantages:
(1) The invention is provided with the guide wire channel, the far end of the bearing component, namely the front end of the catheter, is provided with the opening, and when in use, the guide wire can enter the guide wire channel through the opening, so that the operation is convenient, and the use habit of doctors is met.
(2) By designing the unique cutting pattern and coating the insulating layer, the carrier member can provide sufficient radial support force when in the second shape (spiral or nearly spiral) to better approximate the vessel wall.
(3) During the use, guide wire and sheath pipe can the combined action, after setting up the sheath pipe promptly, can control the guide wire in the guide wire passageway removal accurately to can make the spiral that has enough big radial holding power straighten.
(4) The inner walls of the bearing component and the transmission component are provided with polymer layers, so that the problem that the NiTi pipe with cutting patterns can scrape the surface coating of the guide wire can be avoided.
(5) Each electrode is independently controlled, the working state of any electrode is not affected by other electrodes, and medical staff can select one, part or all of the electrodes to release energy according to actual needs. The device for adjusting the nerves is convenient to operate, can simultaneously adjust a plurality of nerve sites or selectively adjust certain nerve sites, so that the working efficiency is improved, the treatment accuracy is further improved, medical staff can flexibly select the working electrode under the condition of certain electrode faults, the processing capacity of equipment unexpected faults is greatly submitted, the normal operation of the operation is ensured, and the device has important clinical significance.
In the present invention, abbreviations used:
PTFE refers to Polytetrafluoroethylene, namely Polytetrafluoroethylene;
PE refers to Polyethylene;
FEP refers to fluorinated ethylene propylene copolymer, fluorinated ethylene propylene;
TPU refers to thermoplastic polyurethane elastomers, thermoplastic polyurethanes;
PET refers to polyethylene terephthalate, polyethylene terephthalate;
pebax refers to polyether block phtalamine elastomers developed by the company Aster Chimie, france, under the trade designation Pebax, with properties intermediate those of synthetic rubber and thermoplastic polyurethane.
For ease of description, the end of the device or component that is proximal to the user (or handle) or the nerve site that is to be modulated is referred to herein as the "distal end" and the end of the device or component that is distal to the user (or handle) or the nerve site that is to be modulated is referred to herein as the "proximal end".
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 and related tissue;
FIG. 2 is a schematic diagram of the structure of a human renal artery;
FIG. 3 is a schematic illustration of the components of one embodiment of a multi-electrode renal artery radiofrequency ablation catheter provided by the present invention, showing a first shape of the carrier member;
FIG. 4 is a schematic view of another state of the multi-electrode renal artery radiofrequency ablation catheter shown in FIG. 3, showing a second shape of the carrier member;
FIG. 5 is a cross-sectional view (taken from the electrode) of a carrier member of one embodiment of a multiple electrode renal artery radiofrequency ablation catheter of the present invention;
FIG. 6 is a perspective view of the cutting pattern of the carrier member of one embodiment of the multiple electrode renal artery radiofrequency ablation catheter of the present invention in a horizontal plane;
FIG. 7 is an exploded view of the handle of one embodiment of the multi-electrode renal artery radiofrequency ablation catheter of the present invention;
FIG. 8 is a partial cross-sectional view of a sheath of one embodiment of a multi-electrode renal artery radiofrequency ablation catheter of the present invention;
fig. 9 is a partial cross-sectional view of a sheath of another embodiment of a multiple electrode renal artery radiofrequency ablation catheter of the present invention.
Detailed Description
Fig. 1-4 illustrate a preferred embodiment of a multi-electrode renal artery radiofrequency ablation catheter and method of use thereof provided by the present invention, for example, for modulating human renal nerves.
Fig. 1 to 2 show the relevant organization and structure of human kidneys. As shown in fig. 1, human kidney-related tissue anatomically includes kidney K, which is supplied with oxygenated blood through renal artery RA. The renal artery RA is connected to the heart via the abdominal aorta AA. Deoxygenated blood flows from the kidneys to the heart via the renal veins RV and the inferior vena cava IVC. Fig. 2 illustrates a portion of the kidney anatomy in more detail. More specifically, the renal anatomy also includes a renal nerve RN extending longitudinally along the axis L of the renal artery RA. The renal nerve RN is typically within the adventitia of the artery. In this embodiment, a device is provided for modulating a renal nerve RN located on a renal artery RA by removing or reducing activation of the renal nerve RN by means of injury or non-injury. As a variation on this embodiment, one skilled in the art could make adjustments that would reasonably be expected without the need for inventive labor in accordance with the present invention if other sites of nerves (e.g., heart-related nerves) were to be modulated, or if other modes of modulation were to be required (e.g., if activation of the nerves were to be further enhanced).
Fig. 3 and 4 illustrate the components of the multi-electrode renal artery radiofrequency ablation catheter in this particular embodiment. As shown in fig. 3 to 4, the catheter includes a regulating assembly 100 for regulating a nerve and a delivery member 201 for delivering the regulating assembly 100 to a location of the nerve. The modulation assembly 100 includes an electrode 101 that delivers modulation energy to the renal nerve and a carrier member 102 for carrying the electrode 101. The carrier member 102 has a first shape (see fig. 3) in which the adjustment assembly 100 is for movement in a blood vessel and a second shape (see fig. 4); in the second shape, at least one electrode 101 is in a position to deliver modulation energy to the renal nerve. In this embodiment, the carrier member 102 and the delivery member 201 are integral, with the proximal end of the carrier member 102 being connected to the distal end of the delivery member 201.
In this embodiment, the electrode 101 delivers modulation energy to the renal nerve site to be modulated in the following manner: 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 101 is required to be conveniently moved in the blood vessel without damaging the blood vessel wall while the electrode 101 can be tightly attached to the inner wall of the blood vessel to act on nerves at corresponding positions.
The multi-electrode renal artery ablation catheter of the present embodiment further includes a sheath 301 and a guidewire channel 500 (see fig. 5). The sheath 301 is sleeved on the conveying member 201, the inner diameter of the sheath 301 is 1.2-1.45 mm, the outer diameter of the sheath 301 is 1.3-1.55 mm, and the sheath 301 can slide along the conveying member 201 and be sleeved on or separated from the adjusting assembly 100. The guidewire channel 500 is disposed within the interior of the multi-electrode renal artery ablation catheter of the present embodiment and extends throughout the multi-electrode renal artery ablation catheter, i.e., there is a portion of the guidewire channel 500 within the interior of the carrier member 102 and within the interior of the delivery member 201. The guidewire channel 500 is used to guide the movement of a guidewire within the interior of the multi-electrode renal artery ablation catheter along the axis of the multi-electrode renal artery ablation catheter. Both the proximal and distal ends of the guidewire channel 500 have openings (see fig. 1). The opening 106 at the distal end of the guidewire channel 500 is for passage of a guidewire into the interior of the multi-electrode renal artery ablation catheter, specifically into the interior of the carrier member 102, and the opening at the proximal end of the guidewire channel 500 is for passage of a 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. One function of the protective member 105 is to reduce or avoid damage to the vessel wall, as it is soft enough to rebound rapidly when it touches the vessel wall, without loss of the vessel; another function of the protecting member 105 is to guide the entire catheter device, 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 smoothly through the kink of the blood vessel. In this embodiment, the protective member 105 is a soft head, made of rubber, silicone or thermoplastic elastomer material. The flexible head has an opening for insertion of a guidewire into the carrier member, i.e., opening 106 at the distal end of guidewire channel 500.
The bearing member 102 and the conveying member 201 are tubular, and are sequentially provided with a polymer layer, a NiTi tube, an inner insulating layer and an outer insulating layer from inside to outside along the radial direction of the tubular shape. Fig. 5 shows a cross-sectional view of the carrier member 102, which is taken from the electrode 101, and it is seen from fig. 5 that the polymer layer 504, the NiTi tube 503, the inner insulating layer 501, and the outer insulating layer 502 are sequentially provided from the inside to the outside in the radial direction of the carrier member 102. The polymer layer 504 of the carrier member 102 and the polymer layer (not shown) of the delivery member 201 are integral and each have a diameter of 0.40 to 0.55mm and a thickness of 0.025 to 0.1mm, and are each formed of a polymer material, which may be PET, FEP, pebax, PE or PTFE.
The carrier 102 is perturbed and pre-treated to have a second shape, and in order to provide sufficient radial support force for the carrier 102 in the second shape, the surface of the NiTi tube 503 of the carrier 102 is laser cut to form a cut pattern, in this embodiment a spiral groove, which is shown in fig. 6 as a projection of the cut pattern in a horizontal plane, in which the carrier 102 is in the first shape. The projection of the spiral groove on the horizontal plane comprises a plurality of straight grooves or a plurality of approximate straight grooves 603, the plurality of straight grooves being located at the distal end of the carrier 102, the plurality of straight grooves comprising a plurality of first straight grooves 601 and a plurality of second straight grooves 602. The spacing between every two adjacent first linear grooves 601 is the same, and the plurality of first linear grooves 601 are parallel to each other; every two adjacent second linear grooves 602 have the same distance, and the plurality of second linear grooves 602 are parallel to each other. The plurality of approximate straight line grooves 603 are located at the proximal end of the carrier 102, and the distance between two adjacent approximate straight line grooves 603 is gradually increased from the distal end to the proximal end of the carrier 102, and the plurality of approximate straight line grooves 603 are not parallel to each other. The first linear groove 601 forms an angle of 75 ° to 85 ° with the axial direction of the carrier 102, the second linear groove 602 forms an angle of 65 ° to 75 ° with the axial direction of the carrier 102, and the approximate linear groove 603 forms an angle of 50 ° to 65 ° with the axial direction of the carrier 102, where the axial direction refers to a direction from the proximal end of the carrier 102 to the distal end of the carrier 102 when the carrier 102 is in the first shape.
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 shrink tubes, and the thickness after heat shrinkage is 0.012-0.05 mm. The outer insulating layer 502 of the carrier 102 is a TPU tube or Pebax tube, and has a diameter of 0.9 to 1.2mm and a thickness of 0.05 to 0.15mm. The outer insulating layer (not shown) of the conveying member 201 is a heat shrinkable tube of PET or FEP, and the thickness after heat shrinkage is 0.012 to 0.1mm.
In this embodiment, the electrode 101 is annular and is sleeved on the outer surface of the outer insulating layer 502 of the carrier 102. Thus, when the carrier 102 is in the second shape (within the renal artery), the electrode 101 on the carrier 102 is in a position to contact the inner wall of the renal artery (near the renal nerve), which allows for the performance of the modulation work. In order to firmly mount the electrode 101 to the outer surface of the outer insulating layer 502 of the carrier member 102 and minimize damage to the vessel wall, glue may be used to bond the electrode 101 to the outer insulating layer 502 of the carrier member 102. The glue can be UV curing glue, epoxy resin glue or a mixture thereof, not only has biocompatibility which can achieve medical use, but also has certain binding force on metal alloy and high polymer materials. In addition, between the outer insulation 502 and the inner insulation 501 of the carrier member 102, wires 505 for providing energy to the electrode 101 and monitoring the temperature and impedance at the time of ablation are provided, the wires 505 extending in the outer insulation and the inner insulation of the delivery member 201, the wires 505 in the carrier member 102 and the wires 505 in the delivery member 201 being integral. The wires 505 are soldered or laser welded to the inner surface of the electrode 101 through the outer insulating layer 502 of the carrier member 102. The outer insulating layer 502 of the carrier member 102 has an opening (not shown) at the location where the electrode 101 is attached, through which a wire 505 connected to an energy generating device, such as a radio frequency meter, is soldered to the inner surface of the electrode 101. By disposing the wire 505 in the outer insulating layer 502, the technical disadvantage of the outer surface roughness of the conveying member caused by the wire having to be disposed on the outer surface of the conveying member for insulation can be avoided, thereby avoiding problems caused by the outer surface roughness of the conveying member. When there are a plurality of electrodes 101, a plurality of wires 505 respectively connecting the plurality of electrodes 101 to the energy generating device need to be provided. Each electrode 101 operates independently, with a separate lead 505. Whether one electrode releases the adjustment energy is independent of the other electrodes; only one or a part of the electrodes can transmit the adjustment energy, and all the electrodes can work simultaneously to transmit the adjustment energy; the state of whether each electrode transmits the adjustment energy is independent of each other. The carrier 102 may also be provided with elements for measuring temperature (e.g. thermocouples) and corresponding wires, the arrangement of wires and thermocouples being conventional in the art and not described in detail herein.
In this embodiment, the first shape of the carrier 102 is straight or approximately straight, but may also be elongated or fibrous or filiform, the cross-section of which is preferably circular or approximately circular, the widest part of the cross-section being smaller than the inner diameter of the blood vessel. Thus, in the first shape, the adjustment assembly 100 does not damage the vessel wall as the adjustment assembly 100 is moved within the vessel. When it is desired to modulate nerves on the renal artery, since the internal diameter of the human renal artery is generally 4-7mm, the maximum dimension of the modulating assembly 100 in the radial direction of the renal artery is no greater than 4mm, preferably 1-2mm, which is both satisfactory for ease of movement within the blood vessel, and is sufficiently rigid and easy to manufacture, and which reduces 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 102 is generally spiral or approximately spiral, and the widest point of the carrier 102 is larger than the first shape in the radial direction of the vessel, so that the carried electrode 101 may be brought into close proximity to or in contact with the vessel wall, thereby approaching the renal nerve.
The diameter of the spiral or nearly spiral of the carrier 102 is set to 4-12 mm and the pitch to 3-10 mm 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 diameter of the spiral or nearly spiral of the carrier 102 may be set to about 5-6 mm; for an individual having a large internal diameter of the renal artery, for example, an internal diameter of about 7mm, the diameter of the spiral or the approximately spiral may be set to about 8 to 9 mm.
The second shape of the carrier 102 may be any other shape, for example, an irregular shape having a rounded curve, as long as the electrode 101 is positioned to contact the vessel wall when the carrier 102 is in the vessel.
The multi-electrode renal artery radiofrequency ablation catheter of the present embodiment switches the carrier member 102 between the first shape and the second shape by the combined action of the sheath 301 and the guide wire, i.e., when the sheath 301 slides along the delivery member 201 and is sleeved on the adjustment assembly 100 while the guide wire is inserted into the guide wire channel 500 from the opening 106 at the distal end of the guide wire channel 500 into the interior of the carrier member 102, the carrier member 102 switches from the second shape to the first shape; when the guide wire is passed out of the opening 107 at the proximal end of the guide wire channel 500 and is withdrawn from the interior of the carrier member 102 while the sheath 301 is slid along the delivery member 201 and out of the adjustment assembly 100, the carrier member 102 is switched from the first shape to the second shape.
In other embodiments, where the radial support force of the carrier 102 is small, switching of the carrier 102 between the first shape and the second shape may be achieved by the separate action of the sheath 301 or the guide wire. The sole function of the sheath 301 is that the carrier 102 switches from the second shape to the first shape when the sheath 301 is slid along the delivery member 201 and over the adjustment assembly 100; when the sheath 301 is slid along the delivery member 201 and out of the adjustment assembly 100, the carrier member 102 switches from the first shape to the second shape. The sole function of the guide wire is that the carrier member 102 switches from the second shape to the first shape when the guide wire is inserted into the guide wire channel 500 from the opening 106 at the distal end of the guide wire channel 500 into the interior of the carrier member 102; when the guide wire is threaded out of the opening 107 at the proximal end of the guide wire channel 500 and is withdrawn from the interior 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 the embodiment is as follows:
(1) Firstly, guiding a guide wire into a preset part of a human body, namely a renal sympathetic nerve on a renal artery of the human body;
(2) Sheathing the sheath 301 over the adjustment assembly 100, and then inserting a guidewire into the carrier member 102 from the first aperture and out of the second aperture such that the carrier member 102 changes from the preformed second shape to the first shape for movement in the blood vessel;
(3) Moving the multi-electrode renal artery radio frequency ablation catheter to a renal sympathetic nerve on a renal artery of the human body;
(4) Pulling the guide wire away from the carrier member 102 and removing the sheath 301 from the adjustment assembly 100, wherein the carrier member 102 changes from the first shape to the second shape, and at this time, the electrode 101 on the carrier member 102 acts on the nerve at the corresponding location against the inner wall of the blood vessel, releasing energy to act on the nerve site, thereby acting to adjust the nerve site (e.g., reduce or eliminate activation of sympathetic nerves);
(5) Sheathing the sheath 301 over the adjustment assembly 100, and then pushing the guidewire into the carrier member 102, the carrier member 102 again changing from the second shape to the first shape;
(6) The multi-electrode renal artery radiofrequency ablation catheter is removed from the body.
The electrode 101 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 101 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 101 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.
Regardless of the energy mode used to achieve the nerve modulation, when a user is working with the catheter provided by the present invention, the electrode 101 needs to be electrically connected to a device that generates the energy (e.g., a radiofrequency meter) or causes the electrode 101 itself to generate the energy. The connection of these devices and electrodes 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 the present embodiment, the number of the electrodes 101 is 4. When the carrier member 102 is in the second shape (spiral shape), the distance D between the adjacent electrodes 101 in the axial direction of the blood vessel is preferably 4 to 12 mm. Generally, when performing renal nerve ablation procedures, ablation is performed at 3-8 sites of the renal nerve. Thus, when working with the device of this embodiment, the ablation of 4 sites can be accomplished with one positioning of the adjustment assembly 100 (with the electrode 101 contacting the inner wall of the vessel), and the entire ablation procedure can be accomplished with only two positioning of the adjustment assembly 100. As a variation of this embodiment, the number of the electrodes 101 may be set to 2 to 6, but if the number is large, the manufacturing cost of the whole device is increased; if the number is small, the working efficiency of the ablation procedure may be reduced. The material of the electrode 101 may be a biocompatible or relatively stable metal or metal alloy, such as a platinum group metal (e.g., platinum iridium alloy).
The guide wire of this embodiment is a wire made of NiTi alloy.
The multi-electrode renal artery radiofrequency ablation catheter of the present embodiment further includes a handle 401 for grasping, the distal end of the handle 401 being connected to the proximal end of the delivery member 201 (see fig. 3). The lead 505 is connected to the handle 401 after extending within the carrier member 102 and the delivery member 201. The handle 401 is provided as one piece with the connection cable of the external energy generator or as separate two parts connected through a switch port. The movement of the sheath 301 of this embodiment is controlled by a control mechanism 7 disposed within the handle 401, see fig. 3 and 7, the control mechanism 7 comprising a tip 701, a tooth block 702 and a gear 703, the tip 701 being located at the distal end of the handle 401 and connected to the sheath 301, the tooth block 702 being connected to the tip 701, the gear 703 being mated to the tooth block 702; rotating gear 703 enables tooth block 702 to push and pull tip 701 so that tip 701 pushes and pulls sheath 301 along delivery member 201.
The sheath 301 is made of a polymer material, such as Pebax or TPU, and is slightly harder than the carrier 102, with 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 0.015-0.5mm, has a small friction coefficient, and mainly plays a smooth role when the sheath 301 slides relatively to the carrier 102. The outer layer 303 is Pebax or TPU, and may contain 20wt% to 40wt% baso 4 or 10wt% to 30wt% BiOCl.
The remainder of the outer layer has a woven mesh tube comprising a first woven wire segment 313, a second woven wire segment 323, and a third woven wire segment 333, as shown in fig. 9, except for the portion of the outer layer that is 1-5 mm from the distal-most end of the sheath 301; the braided filaments of the first braided filament segment 313, the second braided filament segment 323, and the third braided filament segment 333 are stainless steel filaments or Ni-Ti filaments. The different durometers of the first, second and third braided wire segments 313, 323, 333 may be achieved by the same braiding and different durometers of Pebax in the outer layer in which they are each located, or by the same Pebax durometer and different braiding. In this embodiment, the braiding of the first, second and third braided wire segments 313, 323 and 333 is different so that the hardness of the portion of the sheath 301 near the distal end 10-20 cm of the handle 401 is greater than the hardness of the other portion of the sheath 301. The hardness of the distal end of the sheath 301 has a transition from small to large to facilitate entry of the multi-electrode renal artery ablation catheter of the present embodiment into a predetermined location of the renal artery.
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 (43)
1. A multi-electrode renal artery ablation catheter comprising a modulation assembly for modulating a nerve and a delivery member for delivering the modulation assembly to a location of the nerve;
The modulation assembly comprises a plurality of electrodes for delivering modulation energy to the nerve and a carrier member for carrying a plurality of the electrodes;
The carrier member has a first shape in which the adjustment assembly is adapted to move in a blood vessel and a second shape; in the second shape, at least one of the electrodes is in a position suitable for delivering the modulation energy to the nerve;
The multi-electrode renal artery ablation catheter is characterized by further comprising a sheath; the sheath tube is sleeved on the conveying component, and the sheath tube can slide along the conveying component and is sleeved on or separated from the adjusting component;
A guide wire channel is arranged in the multi-electrode renal artery ablation catheter, the guide wire channel penetrates through the whole multi-electrode renal artery ablation catheter, and the guide wire channel is used for guiding a guide wire to move in the multi-electrode renal artery ablation catheter along the axial direction of the multi-electrode renal artery ablation catheter;
The multi-electrode renal artery ablation catheter is configured to: switching the carrier member between the first shape and the second shape is enabled by a separate action of the sheath or the guide wire or by a combined action of the sheath and the guide wire;
The bearing component and the conveying component are tubular, and a polymer layer, a NiTi pipe, an inner insulating layer and an outer insulating layer are sequentially arranged along the radial direction of the tubular shape from inside to outside; the surface of the NiTi pipe of the bearing component is provided with cutting patterns, and the cutting patterns are spiral grooves formed on the surface of the NiTi pipe of the bearing component by laser cutting; when the bearing component is in the first shape, the projection of the spiral groove on the horizontal plane comprises a plurality of straight grooves and a plurality of approximate straight grooves; the plurality of linear grooves are positioned at the distal end of the bearing component, and the plurality of linear grooves comprise a plurality of first linear grooves and a plurality of second linear grooves; the distance between every two adjacent first linear grooves is the same, and a plurality of first linear grooves are parallel to each other; the distance between every two adjacent second linear grooves is the same, and a plurality of second linear grooves are mutually parallel; the included angle between the first linear groove and the axial direction of the bearing component is 75-85 degrees, the included angle between the second linear groove and the axial direction of the bearing component is 65-75 degrees, the included angle between the approximate linear groove and the axial direction of the bearing component is 50-65 degrees, and the axial direction refers to the direction from the proximal end of the bearing component to the distal end of the bearing component when the bearing component is in the first shape; the plurality of approximate straight line grooves are positioned at the proximal end of the bearing component, the distance between every two adjacent approximate straight line grooves is gradually increased from the distal end to the proximal end of the bearing component, and the plurality of approximate straight line grooves are not parallel to each other.
2. The multiple-electrode renal artery ablation catheter of claim 1, wherein the sole action of the sheath is to switch the carrier member from the second shape to the first shape when the sheath is slid along the delivery member and over the adjustment assembly; the carrier member switches from the first shape to the second shape when the sheath slides along the delivery member and disengages the adjustment assembly.
3. The multiple electrode renal artery ablation catheter of claim 1, wherein both a proximal end and a distal end of the guidewire channel have openings.
4. The multiple-electrode renal artery ablation catheter of claim 3, wherein the single action of the guide wire is that the carrier member switches from the second shape to the first shape when the guide wire is inserted into the guide wire channel from the opening of the distal end of the guide wire channel into the interior of the carrier member; the carrier member switches from the first shape to the second shape when the guide wire is threaded out of the opening of the proximal end of the guide wire channel and is withdrawn from the interior of the carrier member.
5. The multiple-electrode renal artery ablation catheter of claim 3, wherein the coaction of the sheath and the guidewire means that the carrier member is switched from the second shape to the first shape when the sheath is slid along the delivery member and over the adjustment assembly while the guidewire is inserted into the guidewire channel from the opening of the distal end of the guidewire channel into the interior of the carrier member; the carrier member is switched from the first shape to the second shape when the guide wire is threaded out of the opening of the proximal end of the guide wire channel and withdrawn from the carrier member while the sheath is slid along the delivery member and out of the adjustment assembly.
6. The multiple electrode renal artery ablation catheter of claim 1, wherein the polymer layer of the carrier member and the polymer layer of the delivery member each have a diameter of 0.40 to 0.55mm and a thickness of 0.025 to 0.1mm.
7. The multiple-electrode renal artery ablation catheter of claim 1, wherein the polymer layer of the carrier member and the polymer layer of the delivery member are integral and formed of a polymer material.
8. The multiple-electrode renal artery ablation catheter of claim 7, wherein said polymeric material is PET, FEP, pebax, PE or PTFE.
9. The multi-electrode renal artery ablation catheter of claim 1, wherein the inner insulating layer of the carrier member and the inner insulating layer of the delivery member are both PET heat shrink tubes, and the thickness after heat shrink is 0.012-0.05 mm.
10. The multi-electrode renal artery ablation catheter of claim 1, wherein the outer insulating layer of the bearing component is a TPU tube or a Pebax tube, and has a diameter of 0.9 to 1.2mm and a thickness of 0.05 to 0.15mm.
11. The multi-electrode renal artery ablation catheter of claim 1, wherein the outer insulating layer of the delivery member is a PET or FEP heat shrink tube, and the thickness after heat shrink is 0.012-0.1 mm.
12. The multiple electrode renal artery ablation catheter of claim 1, wherein said electrode is sleeved outside of an outer insulation layer of said carrier member and secured thereto by adhesive reinforcement.
13. The multi-electrode renal artery ablation catheter of claim 12, wherein the adhesive is a UV curable glue or an epoxy glue.
14. The multiple electrode renal artery ablation catheter of claim 12, wherein a plurality of said electrodes are individually controlled to release energy.
15. The multiple electrode renal artery ablation catheter of claim 12, wherein a plurality of said electrodes simultaneously control release energy.
16. The multiple electrode renal artery ablation catheter of claim 14 or 15, wherein an inner surface of each of said electrodes is connected to a lead for providing said adjustment energy to said electrodes and monitoring temperature and impedance at the time of ablation.
17. The multiple-electrode renal artery ablation catheter of claim 16, wherein the lead is disposed between and extends between the outer insulation layer and the inner insulation layer of the carrier member.
18. The multiple electrode renal artery ablation catheter of claim 17, wherein the lead is soldered or laser welded to the inner surface of the electrode through the outer insulation layer of the carrier member.
19. The multi-electrode renal artery ablation catheter of claim 1, wherein the first shape of the carrier member is straight or approximately straight.
20. The multi-electrode renal artery ablation catheter of claim 1, wherein the second shape of the carrier member is a spiral or near-spiral shape.
21. The multiple electrode renal artery ablation catheter of claim 20, wherein the spiral or the approximately spiral has a diameter of 4 to 12mm and a pitch of 3 to 10mm.
22. The multi-electrode renal artery ablation catheter of claim 1, wherein the carrier member is flexible and is pre-treated to have the second shape.
23. The multiple electrode renal artery ablation catheter of claim 1, wherein the electrode is annular in cross-section.
24. The multiple electrode renal artery ablation catheter of claim 1, wherein the number of electrodes is between 2 and 6, and wherein the distance between adjacent electrodes is between 4 and 12mm when the carrier member is in the first shape.
25. The multiple-electrode renal artery ablation catheter of claim 1, wherein the electrode is made of platinum iridium alloy or gold.
26. The multi-electrode renal artery ablation catheter of claim 1, further comprising a handle for grasping, a distal end of the handle being connected to a proximal end of the delivery member.
27. The multiple electrode renal artery ablation catheter of claim 26, wherein a control mechanism is disposed within the handle, the control mechanism for controlling movement of the sheath.
28. The multiple electrode renal artery ablation catheter of claim 27, wherein said control mechanism comprises a tip, a tooth block, and a gear, said tip being located at a distal end of said handle and connected to said sheath, said tooth block being connected to said tip, said gear being mated to said tooth block; rotating the gear can cause the tooth block to push and pull the tip, so that the tip pushes and pulls the sheath to move along the delivery component.
29. The multi-electrode renal artery ablation catheter of claim 1, wherein said carrier member and said delivery member are integral.
30. The multiple-electrode renal artery ablation catheter of claim 1, wherein a proximal end of said carrier member is connected to a distal end of said delivery member.
31. The multiple electrode renal artery ablation catheter of claim 1, wherein the sheath has an inner diameter of 1.2 to 1.45mm and an outer diameter of 1.3 to 1.55mm.
32. The multi-electrode renal artery ablation catheter of claim 26, wherein said sheath comprises an inner layer and an outer layer.
33. The multiple electrode renal artery ablation catheter of claim 32, wherein the inner layer is PTFE and has a thickness of from 0.015 mm to 0.5mm.
34. The multiple electrode renal artery ablation catheter of claim 32, wherein the outer layer is Pebax or TPU, and wherein the Pebax or TPU comprises 20wt% to 40wt% baso 4 or 10wt% to 30wt% BiOCl.
35. The multiple electrode renal artery ablation catheter of claim 32, wherein a remainder of said outer layer has a woven mesh tube except for a portion of said outer layer that is 1-5 mm from a distal-most end of said sheath.
36. The multiple electrode renal artery ablation catheter of claim 35, wherein said braided mesh tube comprises a first braided wire segment, a second braided wire segment, and a third braided wire segment.
37. The multiple-electrode renal artery ablation catheter of claim 36, wherein the braided filaments of said first braided filament segment, said second braided filament segment, and said third braided filament segment are stainless steel filaments or NiTi filaments.
38. The multiple-electrode renal artery ablation catheter of claim 36, wherein said first braided wire segment, said second braided wire segment, and said third braided wire segment are braided differently such that a portion of said sheath proximate to a distal end of said handle that is 10-20 cm has a greater durometer than other portions of said sheath.
39. The multi-electrode renal artery ablation catheter of claim 35, wherein the distal end of the sheath has a transition from small to large in stiffness to facilitate entry of the multi-electrode renal artery ablation catheter into a renal artery at a predetermined location.
40. 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.
41. The multi-electrode renal artery ablation catheter of claim 40, wherein said protective member is a soft head.
42. The multiple electrode renal artery ablation catheter of claim 41 wherein said soft head has an opening for insertion of said guide wire into said carrier member, said soft head opening being an opening distal to said guide wire channel.
43. The multi-electrode renal artery ablation catheter of claim 40, wherein said protective member is made of rubber, silicone, or a thermoplastic elastomer material.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNPCT/CN2016/073478 | 2016-02-04 | ||
| PCT/CN2016/073478 WO2017132935A1 (en) | 2016-02-04 | 2016-02-04 | Multi-electrode renal artery ablation catheter |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN107028651A CN107028651A (en) | 2017-08-11 |
| CN107028651B true CN107028651B (en) | 2024-06-07 |
Family
ID=
Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN203790028U (en) * | 2013-12-09 | 2014-08-27 | 上海安通医疗科技有限公司 | Catheter device used for regulating nerves |
| CN104127233A (en) * | 2013-05-03 | 2014-11-05 | 上海安通医疗科技有限公司 | Nerve regulation apparatus |
| CN203935269U (en) * | 2014-06-24 | 2014-11-12 | 上海安通医疗科技有限公司 | A kind of for regulating the pipe guide of kidney nerve |
| CN203970538U (en) * | 2014-06-20 | 2014-12-03 | 上海安通医疗科技有限公司 | A kind of multi-electrode radio frequency ablation catheter for renal artery |
| CN204072314U (en) * | 2014-08-27 | 2015-01-07 | 上海安通医疗科技有限公司 | A kind of for regulating neural pipe guide |
| CN104688331A (en) * | 2013-12-09 | 2015-06-10 | 上海安通医疗科技有限公司 | Catheter device used for regulating nerves |
| CN104812325A (en) * | 2012-09-26 | 2015-07-29 | 波士顿科学国际有限公司 | Catheter having rib and spine structure supporting multiple electrodes for renal nerve ablation |
| CN205814415U (en) * | 2016-02-04 | 2016-12-21 | 上海安通医疗科技有限公司 | A kind of multi-electrode radio frequency ablation catheter for renal artery |
Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104812325A (en) * | 2012-09-26 | 2015-07-29 | 波士顿科学国际有限公司 | Catheter having rib and spine structure supporting multiple electrodes for renal nerve ablation |
| CN104127233A (en) * | 2013-05-03 | 2014-11-05 | 上海安通医疗科技有限公司 | Nerve regulation apparatus |
| CN203790028U (en) * | 2013-12-09 | 2014-08-27 | 上海安通医疗科技有限公司 | Catheter device used for regulating nerves |
| CN104688331A (en) * | 2013-12-09 | 2015-06-10 | 上海安通医疗科技有限公司 | Catheter device used for regulating nerves |
| CN203970538U (en) * | 2014-06-20 | 2014-12-03 | 上海安通医疗科技有限公司 | A kind of multi-electrode radio frequency ablation catheter for renal artery |
| CN203935269U (en) * | 2014-06-24 | 2014-11-12 | 上海安通医疗科技有限公司 | A kind of for regulating the pipe guide of kidney nerve |
| CN204072314U (en) * | 2014-08-27 | 2015-01-07 | 上海安通医疗科技有限公司 | A kind of for regulating neural pipe guide |
| CN205814415U (en) * | 2016-02-04 | 2016-12-21 | 上海安通医疗科技有限公司 | A kind of multi-electrode radio frequency ablation catheter for renal artery |
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