WO2013139178A1 - 一种消融电极及采用该电极的灌注型电极导管 - Google Patents
一种消融电极及采用该电极的灌注型电极导管 Download PDFInfo
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- WO2013139178A1 WO2013139178A1 PCT/CN2013/000335 CN2013000335W WO2013139178A1 WO 2013139178 A1 WO2013139178 A1 WO 2013139178A1 CN 2013000335 W CN2013000335 W CN 2013000335W WO 2013139178 A1 WO2013139178 A1 WO 2013139178A1
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- insert
- temperature sensor
- distal end
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
- A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
- A61B2018/00029—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00053—Mechanical features of the instrument of device
- A61B2018/00059—Material properties
- A61B2018/00065—Material properties porous
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00053—Mechanical features of the instrument of device
- A61B2018/00059—Material properties
- A61B2018/00089—Thermal conductivity
- A61B2018/00101—Thermal conductivity low, i.e. thermally insulating
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00053—Mechanical features of the instrument of device
- A61B2018/00166—Multiple lumina
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00351—Heart
- A61B2018/00357—Endocardium
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00577—Ablation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00791—Temperature
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
- A61B2218/002—Irrigation
Definitions
- the present application claims priority to Chinese Patent Application No. 20121007950, filed on March 23, 2012, the entire content of BACKGROUND OF THE INVENTION 1.
- Field of the Invention The present invention relates to an ablation electrode and a perfusion type electrode catheter using the same, and, in particular, to an ablation electrode with a temperature sensor and a perfusion type electrode catheter using the same.
- BACKGROUND OF THE INVENTION Leads have been widely used in clinical practice for many years. They can be used to map, stimulate, and ablate electrical activity within the heart.
- the lead enters the body through the main vein or artery, such as through the femoral vein, and then into the heart chamber of interest.
- the catheter it is also desirable for the catheter to have the ability to inject and/or withdraw fluid, which can be accomplished by a perfusion catheter.
- An example of a specific application is catheter intracardiac ablation to generate ablation lesions within the heart to intercept abnormal cardiac conduction pathways within the heart.
- a typical ablation procedure involves inserting a catheter with an ablation electrode at its distal end into the heart chamber, providing a reference electrode that is typically attached to the patient's skin surface, and a radio frequency (RF) voltage applied to the ablation and reference electrodes. Between the generation of RF current flowing through the medium, including blood and tissue. The distribution of the current depends on the ratio of the ablation electrode to the tissue contact area and the area of contact with the blood. After the heart tissue is fully heated by the radio frequency current thermal effect, the tissue cells are destroyed, resulting in damage in the heart tissue, and the damaged tissue does not form electricity. Conduction.
- the heated tissue simultaneously heats the ablation electrode by heat conduction. If the electrode temperature is high enough, such as above 60 ° C, a thin film of dehydration of blood proteins can be formed on the surface of the electrode. If the temperature is further increased, the dehydrated protein layer will gradually thicken and cause blood coagulation on the electrode surface. . Since the conductivity of the dehydrated biomaterial is lower than that of the intracardiac tissue, the impedance of the RF current flowing into the tissue is also increased, and the impedance is high to a certain extent, and the catheter must be taken out to clean the ablation electrode.
- Another way to achieve the desired effect described above is to perfuse the ablation electrode, such as using room temperature saline to actively cool the ablation electrode rather than relying on the cooling effect of the passive blood.
- the electrode is effectively cooled, and the surface temperature is no longer the main factor that causes impedance rise or even blood clot. Therefore, the RF current intensity is no longer limited by the surface temperature, and the current can be increased, which leads to larger and more formation. Damage that approaches a sphere, usually on a scale of 10mm to 12mm.
- a perfusion type electrode made of a porous material which is a metal structure formed by sintering fine particles, and a plurality of interconnected channels for cooling the liquid to the electrode structure, is disclosed in U.S. Patent Nos. 5,643,197 and 5,462,521. More effective. Moreover, the porous structure allows the liquid to flow uniformly over the surface of the electrode as a barrier between the blood and the surface of the electrode.
- the present invention provides an ablation electrode for a catheter, comprising an electrode housing, an optional cavity in the electrode housing, and a temperature sensor; the electrode housing is provided with a liquid passage for the perfusion liquid to flow out a liquid passage for inflow of perfusion liquid is provided at a proximal end of the electrode housing; A heat conduction isolation structure is disposed between the sensor and the liquid passage, and the electrode housing at the position where the temperature sensor is located is less than 0.2 mm.
- optional means the meaning of “optional” or “non-essential”.
- optional cavity means that the cavity may or may not be present. This can be selected by a person skilled in the art depending on the situation.
- the electrode housing is provided with a through hole, and the temperature sensor is disposed in the through hole.
- the proximal end of the electrode housing is provided with an insert, the distal end of the insert extends into the cavity, and includes at least one through hole; The end extends into the through hole of the electrode housing, the proximal end of which is open at the proximal end of the insert, and the distal end is open on the outer surface of the electrode housing, flush with the outer surface of the electrode housing.
- the temperature sensor is disposed at a distal end of the through hole of the insert.
- the diameter of the through hole on the electrode housing may be less than 1 mm; preferably, the diameter of the through hole on the electrode housing is less than 0.5 mm.
- the proximal end of the electrode housing is provided with an insert, the distal end of the insert extends into the cavity, and includes at least one through hole; The end extends to the inner surface of the electrode housing, flush with the inner surface of the electrode housing, or partially extends into the electrode housing; the proximal end of the through hole of the insert is open at the proximal end of the insert.
- the distal end is an open or closed structure, and the temperature sensor is disposed at a distal end of the through hole of the insert; preferably, the thickness of the electrode housing at the position where the temperature sensor is located is less than 0.1 mm.
- the heat conduction isolation structure is a non-metal insulation layer.
- the non-metallic heat insulation layer may be disposed on an inner wall and/or an outer wall of the through hole of the insert; preferably, A part or all of the inner wall and/or the outer wall of the through hole of the insert is provided with a non-metallic heat insulating layer.
- the distance between the temperature sensing portion of the temperature sensor and the tip of the temperature sensor may be less than
- the distance between the temperature sensing portion of the temperature sensor and the tip of the temperature sensor is less than 0.2 mm; more preferably, the temperature sensing portion of the temperature sensor is less than 0.1 mm from the tip of the temperature sensor.
- the non-metallic heat insulating layer may be made of a polymer material or ceramic.
- the present invention provides a perfusion type electrode catheter comprising a catheter body having a proximal end, a distal end and a central chamber therethrough;
- the ablation portion includes a length of elastic end tube having a proximal end, a distal end and at least one through chamber, the proximal end of which is fixedly coupled to the distal end of the catheter body;
- An ablation electrode fixedly coupled to the distal end of the ablation portion including an electrode housing, an optional cavity in the electrode housing, and a temperature sensor; the electrode housing is provided with a liquid passage for the perfusion liquid to flow out, the electrode housing a proximal end of the body is provided with a liquid passage for inflow of the perfusion liquid; a thermal conduction isolation structure is disposed between the temperature sensor and the liquid passage, and an electrode housing at a position where the temperature sensor is located is less than 0.2 mm;
- the perfusion channel has a proximal end and a distal end, the distal end of which extends through the central lumen of the catheter body into the chamber of the ablation portion in communication with the fluid passage of the ablation electrode.
- the electrode housing is provided with a through hole, and the temperature sensor is disposed in the through hole.
- the proximal end of the electrode housing is provided with an insert, the distal end of the insert extends into the cavity, and includes at least one through hole; The end extends into the through hole of the electrode housing, the proximal end of which is open at the proximal end of the insert, the distal end Opening on the outer surface of the electrode housing is flush with the outer surface of the electrode housing, and the temperature sensor is disposed at a distal end of the through hole on the insert.
- the diameter of the through hole on the electrode housing may be less than 1 mm; preferably, the diameter of the through hole on the electrode housing is less than 0.5 mm.
- the proximal end of the electrode housing is provided with an insert, the distal end of the insert extends into the cavity, and includes at least one through hole; The end extends to the inner surface of the electrode housing, flush with the inner surface of the electrode housing, or partially extends into the electrode housing; the proximal end of the through hole of the insert is open at the proximal end of the insert.
- the distal end is an open or closed structure, and the temperature sensor is disposed at a distal end of the through hole of the insert; preferably, the thickness of the electrode housing at the position where the temperature sensor is located is less than 0.1 mm.
- a perfusion channel is disposed in the perfusion channel, and the distal end of the perfusion tube may be a distal end of the chamber extending through the control handle, the central cavity of the catheter body to the ablation portion, and the fluid passage of the ablation electrode Alternatively, it may be through the control handle extending to the distal end of the central chamber of the catheter body to communicate with at least one through chamber of the ablation portion.
- the heat conduction isolation structure is a non-metal insulation layer.
- the non-metallic heat insulation layer may be disposed on the inner wall and/or the outer wall of the through hole of the insert; preferably, a part or all of the inner wall and/or the outer wall of the through hole of the insert is provided with a non-metal heat insulation layer.
- the distance between the temperature sensing portion of the temperature sensor and the tip of the temperature sensor may be less than 0.5 mm; preferably, the distance between the temperature sensing portion of the temperature sensor and the tip of the temperature sensor is less than 0.2 mm; more preferably, the temperature sensor sense The distance from the temperature portion to the tip of the temperature sensor is less than 0.1 mm.
- the non-metallic heat insulating layer may be made of a polymer material or ceramic.
- the perfusion type electrode guide comprises a heat conduction isolation structure, so that the temperature sensor is separated from the perfusion liquid cooling effect, and the cooling effect of the perfusion liquid on the location where the temperature sensor is located is weakened, and the periphery is from the electrode.
- the heating effect of the heat conduction of the outer wall of the housing on the portion where the temperature sensor is located is maintained; and the temperature sensor is disposed in the inner surface of the electrode housing or the through hole of the electrode housing or partially extends into the electrode housing; therefore, The temperature sensor detects more temperature rises caused by the RF current heating effect.
- Figure 1 is a schematic view showing the structure of a perfusion type electrode catheter according to the present invention.
- FIG. 2 is a cross-sectional view of the catheter body 12 in accordance with a preferred embodiment of the present invention, showing the connection relationship of the catheter body 12 with the ablation portion 13;
- Figure 3 is a cross-sectional view taken along line A-A of Figure 1;
- Figure 4 is a cross-sectional view taken along line B-B of Figure 3;
- Figure 5 is a cross-sectional view taken along line C-C of Figure 3;
- FIG. 6 is a schematic illustration of a temperature sensor 33 in an ablation electrode 17 in accordance with a preferred embodiment of the present invention.
- Figure 7 is a cross-sectional view of an ablation electrode 17 in accordance with yet another preferred embodiment of the present invention.
- FIG. 8 is a structural view of an ablation electrode 17 in accordance with still another preferred embodiment of the present invention.
- Figure 9 is a cross-sectional view of the ablation electrode 17 shown in Figure 8.
- Figure 10 is a cross-sectional view of an ablation electrode 17 in accordance with yet another preferred embodiment of the present invention
- Figure 11 is a cross-sectional view of the ablation electrode 17 according to Figure 10.
- Figure 12 is a cross-sectional view of an ablation electrode 17 in accordance with yet another preferred embodiment of the present invention.
- Figure 13 is a cross-sectional view of an ablation electrode 17 in accordance with yet another preferred embodiment of the present invention.
- Figure 14 is a cross-sectional view of an ablation electrode 17 in accordance with yet another preferred embodiment of the present invention.
- FIG. 1 is a schematic view showing the structure of a perfusion type electrode catheter 10 with a temperature sensor according to the present invention, comprising a catheter body 12 having a distal end and a proximal end, and ablation at the distal end of the catheter body 12
- a control handle 11 is provided at the proximal end of the catheter body 12.
- FIG. 2 is a cross-sectional view of a catheter body 12 according to an embodiment of the present invention, showing a connection relationship between the catheter body 12 and the ablation portion 13; the catheter body 12 includes a reinforcing tube 22 and a body tube sheathed on the outside thereof 28.
- the body tube 28 can be made of a biocompatible polymeric material, such as a polyether block amide, polyurethane or nylon material, preferably having at least one layer of wire braid therein.
- the wire braid may be one layer, two layers or more;
- the reinforcing tube 22 includes a central chamber 23, and the reinforcing tube 22 may be any suitable Made of a polymeric material, for example extruded from a polyether block amide, polyurethane, polyimide or nylon material;
- the conduit body is preferably elongate, bendable, but generally incompressible in its length direction, The axial extension of the central chamber 23 in the catheter body 12 A lead 25, a pull wire 21 and a perfusion line 26 extend within the central chamber 23.
- the ablation portion 13 includes an elastomeric tip tube 31 that may be made of a biocompatible material, including a distal end, a proximal end, and at least one chamber, which may be a central chamber or an eccentric chamber.
- the elastic head end tube 31 includes a first eccentric chamber 35, a second eccentric chamber 36, and a third eccentric chamber 37.
- the The wall of the elastic head end tube 31 includes at least one wire braid (not shown), which may be a stainless steel wire braid, and the wire braid may be one layer, two layers or more.
- the proximal end of the elastic head end tube 31 is a grinding end 34.
- the outer diameter thereof matches the inner diameter of the catheter body 12, and the grinding end 34 is inserted into the catheter body 12, It can be fixed by bonding, welding or other suitable means, for example by means of UV-curing glue, to the catheter body 12.
- FIG. 3 is a cross-sectional view taken along line AA of FIG. 1
- FIG. 4 is a cross-sectional view taken along line BB of FIG. 3
- FIG. 5 is a cross-sectional view taken along line CC of FIG. It is a schematic diagram of the temperature sensor 33 shown in FIGS. 4 and 5.
- An ablation electrode 17 is disposed at a distal end of the elastic head end tube 31, and a ring electrode 16 is disposed along a length direction of the elastic head end tube 31, and the number thereof may be different according to actual needs, and may have no ring electrode, Can be one, two, three, four or more.
- the ablation electrode 17 includes an electrode housing 71 and a cavity 76 therein.
- the electrode housing 71 is further provided with a through hole 79 having a diameter of less than 1 mm.
- the through hole 79 has a diameter of less than 0.5 mm.
- the outer surface of the electrode housing 71 is a portion that can come into contact with the ablated tissue; the cavity inside the electrode housing 71 is a portion that cannot be in contact with the tissue.
- the cavity 76 is provided with an insert 74.
- the insert 74 is disposed at the proximal end of the electrode housing 71, and the distal end thereof extends to The cavity 76.
- the insert 74 can be cylindrical, disc shaped or other suitable shape including at least a through hole 81, the distal end of which extends into the through hole 79 of the electrode housing 71.
- the extension of the through hole 81 may be integrally formed with the insert 74, or may be formed separately, such as inserting a hollow tube into the through hole 81 or connecting the distal end of the through hole 81. Pipe or other suitable structure.
- a proximal end of the through hole 81 is open at a proximal end of the insert 74, and a distal end of the through hole 81 is open on an outer surface of the electrode housing 71, and is flat with an outer surface of the electrode housing 71.
- the distal end of the through hole 81 is provided with a temperature sensor 33, and the temperature sensor 33 is fixed by bonding.
- the temperature sensor 33 is located at a through hole in the electrode housing, where the electrode housing has a thickness of zero.
- the position of the through hole 81 may be an axial position close to the electrode housing 71 or a side wall close to the electrode housing 71.
- the insert also includes a through hole 80 that is a liquid passage for the infusion liquid to flow in.
- the temperature sensor 33 is externally sheathed with an outer sleeve 332 made of an insulating or insulating heat insulating material.
- the distance between the temperature sensing portion 331 of the temperature sensor 33 and the top end of the temperature sensor is less than 0.5 mm.
- the distance between the temperature sensing portion of the temperature sensor and the tip of the temperature sensor is less than 0.2 mm ; more preferably, The distance between the temperature sensing portion of the temperature sensor and the tip of the temperature sensor is less than 0.1 mm.
- the insulating heat conductive adhesive 333 may be disposed between the temperature sensing portion 331 and the top end, so that the sensitivity of the temperature sensor can be improved while providing sufficient insulation.
- the top end of the temperature sensor 33 may be flush with the outer surface of the electrode housing, or may be located near the outer surface of the electrode housing, as a small portion of the top end of the temperature sensor 33 protrudes beyond the outer surface, Or a small part is shrunk into the outer surface.
- the insert 74 also includes a blind bore 82 having a pull wire 21 secured therein.
- the through hole 80, the through hole 81 and the blind hole 82 respectively form a first eccentric chamber 35 and a second eccentric chamber of the elastic head end tube 31 36 is in communication with the third eccentric chamber 37.
- hollow tubes may be welded or bonded to the three holes 80, 81, 82 of the insert 74, respectively, which may be constructed of a suitable polymeric or metallic material, such as polyimide or stainless steel.
- a heat conduction isolation structure is disposed between the temperature sensor 33 and the liquid passage, and the heat conduction isolation structure is a non-metal insulation layer 78 disposed on the through hole 81.
- the non-metallic insulating layer 78 is disposed on the inner wall and/or the outer wall of the through hole 81.
- the inner wall and/or the outer wall of the through hole 81 described herein may mean the inner wall and/or the outer wall of a section of the through hole 81 extending in the cavity, and may also refer to the inner wall and/or the outer wall of the entire through hole 81.
- the non-metallic heat insulating layer 78 may be a tubular heat insulating layer inserted into the inner wall and/or the outer wall of the through hole 81, or may be coated with non-metal heat insulation on the inner wall and/or the outer wall of the through hole 81.
- Floor When the insert 74 is a non-metallic material, the through hole 81 itself can serve as a non-metallic insulating layer.
- the non-metallic heat insulation layer 78 is disposed on the inner wall of the through hole 81. And / or the outer wall.
- the extension of the insert through-hole 81 is a non-metallic material, the through-hole 81 itself can serve as a non-metallic insulating layer.
- the non-metallic heat insulating layer 78 may cover the inner wall and/or the outer wall of the through hole 81, or may be partially covered. When the non-metallic insulating layer 78 is partially covered, the degree of thermal isolation can be adjusted to adjust the temperature measured by the temperature sensor 33. The degree of thermal isolation can also be adjusted when changing the material of the non-metallic insulating layer or its thickness.
- the non-metallic insulating layer 78 is made of a non-metallic material having a heat insulating function, may be made of a polymer material, may be made of ceramic or made of other suitable non-metal materials.
- the non-metallic insulating layer 78 may be made of a high temperature resistant non-metallic material.
- the temperature is made The degree sensor is separated from the perfusion liquid cooling effect, and the cooling effect of the perfusion liquid on the temperature sensor is weakened, and the temperature sensor will detect more temperature rise caused by the RF current heating effect.
- the insert 74 may be entirely disposed within the cavity of the electrode housing 71 or partially within the cavity of the electrode housing 71, as shown in FIG.
- the temperature sensor 33 may be a thermocouple, a thermistor or the like; the number of the temperature sensors may be one, two, three or more, as shown in FIG. 4, the distal end of the temperature sensor 33 passes The central chamber 23 of the catheter body 12 extends into the second eccentric chamber 36 of the elastomeric tip tube 31 and then extends into the through hole 81 and is fixed to the distal end of the through hole 81 by bonding. The proximal end of the temperature sensor 33 extends through the central chamber 23 into the control handle 11 and extends from the control handle 11 to be coupled to a temperature monitoring device (not shown).
- the electrode housing 71 is provided with a plurality of small holes (not shown) as a liquid passage for the perfusion liquid to flow out.
- the apertures may be provided by any suitable means, either by mechanical, laser or electrical machining, or by a porous material.
- a perfusion channel having a proximal end and a distal end, the distal end of which extends into the first eccentric chamber 35 of the elastic tip end tube 31 through the control handle 11, the central chamber 23 of the catheter body 12, and communicates with the fluid passage of the ablation electrode 17.
- a perfusion line 26 is provided in the perfusion channel, and the distal end of the perfusion line 26 may be the first to extend through the central handle 23 of the catheter body 12 to the elastic tip end tube 31 through the control handle 11.
- the distal end of the eccentric chamber 35 is in communication with the fluid passage of the ablation electrode 17; it may also be the distal end of the central chamber 23 extending through the control handle 11 to the catheter body 12, and the first end of the elastic tip end tube 31
- the eccentric chambers 35 are in communication.
- the perfusion line 26 can be made of any suitable material with its distal end passing through the catheter body 12
- the central chamber 23 extends into the first eccentric chamber 35 of the elastomeric tip tube 31 and communicates with the through hole 80 in the insert 74.
- the proximal end of the perfusion line 26 extends through the central chamber 23 of the catheter body 12 into the control handle 11, the method of attachment being secured by any suitable method known to those skilled in the art, such as in the perfusion line
- the proximal end of 26 is connected to a length of branch pipe 14, as shown in Fig. 1, which extends to the outside of the control handle 11, and the end portion is fixedly connected to the luer connector 15.
- the perfusion liquid can be any suitable liquid, such as physiological saline, which enters the perfusion line 26 through the branch tube 14 and enters the cavity of the ablation electrode 17 through the perfusion line 26 and the through hole 80. Within 76, flow through the aperture in the electrode housing to the exterior of the conduit 10.
- a length of the traction wire 21 extending inside the catheter body 12 is preferably sleeved with a spring tube 29, and the spring tube 29 is preferably a tight structure with a tightening force, and the outer sleeve is sleeved with a second protective sleeve ( Not shown), the second protective sleeve may be made of any suitable material, preferably made of a polyamide material, for the spring tube 29 to extend therein; the distal end of the second protective sleeve And the proximal end may be secured to the spring tube 29 by bonding, welding or other suitable means, such as by bonding to the spring tube 29 by means of a UV curable glue; as shown in Figure 5, at the elastic head end A length of the traction wire 21 extending within the tube
- the distal end of the pull wire 21 extends into the aperture 82 in the insert 74,
- the ends are fixed by welding, bonding or other suitable means, preferably by welding.
- the proximal end of the pull wire 21 is secured to the control handle 11, and the method of attachment can be secured by any suitable method known to those skilled in the art.
- the wire 25, as shown in Figures 2 and 3 and 4, has its distal end extending through the central chamber 23 into the second eccentric chamber 36 of the elastomeric tip tube 31, respectively with the ablation electrode 17, the ring electrode 16, and the temperature
- the sensors 33 are connected in a manner that is welded or otherwise suitable, preferably by splicing.
- a wire retaining tube 27 is provided outside the wire 25.
- the proximal end of the lead 25 is secured to the control handle 11, and the method of attachment can be secured by any suitable means known to those skilled in the art, such as by splicing to a corresponding plug.
- a non-metallic thermal insulation layer 78 is disposed on the through hole 81 of the insert 74, and the temperature sensor 33 can be provided.
- the inner surface of the electrode housing 71 or the through hole of the electrode housing 71 is partially or partially disposed in the electrode housing, and the ablation electrode of the present invention is used under the same clinically used catheter radiofrequency ablation power and perfusion conditions.
- the temperature is closer to the tissue temperature.
- the temperature sensor 33 is disposed on the inner surface of the electrode housing 71. More preferably, the temperature sensor 33 is partially disposed in the electrode housing 71. Particularly preferably, the temperature sensor 33 is provided in the through hole of the electrode housing 71.
- FIG. 8 is a cross-sectional view of the ablation electrode 17 in accordance with yet another embodiment of the present invention.
- the ablation electrode 17 includes an electrode housing 71 and a cavity 76 therein, and an insert 74 is provided at a proximal end of the electrode housing 71.
- the insert 74 can be cylindrical, disc shaped or otherwise
- a suitable shape includes at least a through hole 81 whose distal end extends into the through hole 79 of the electrode housing 71.
- the extension of the through hole 81 and the insert 74 may be integrally formed, or may be formed separately, such as inserting a hollow tube into the through hole 81 or connecting the distal end of the through hole 81. Pipe or other suitable structure.
- the proximal end of the through hole 81 is open at the proximal end of the insert 74, and the distal end of the through hole 81 is turned inside the cavity 76 to extend to the through hole 79 on the sidewall of the electrode housing 71. And open on the side wall, flush with the outer surface of the electrode housing 71, as shown in FIG.
- the distal end of the through hole 81 is provided with a temperature sensor 33, and the temperature sensor 33 is fixed by bonding.
- the insert 74 also includes a through hole 80 that is a liquid passage for the infusion liquid to flow in.
- the through hole 80 and the through hole 81 communicate with the first eccentric chamber 35 and the second eccentric chamber 36 of the elastic head end tube 31, respectively.
- the through hole 81 is provided with a non-metal heat insulation layer 78.
- the non-metal heat insulation layer 78 is provided on the inner wall and/or the outer wall of the through hole 81.
- the through hole 81 itself can serve as a non-metallic insulating layer.
- the non-metallic heat insulation layer 78 is disposed on the inner wall of the through hole 81. And / or the outer wall.
- the remaining structure of the catheter 10 is the same as that shown in Figs. 4 and 5.
- Fig. 9 is a structural view of an ablation electrode 17 according to still another embodiment of the present invention.
- the ablation electrode 17 includes a cylindrical side wall surface 77 and a rounded top surface 75.
- the ablation electrode 17 may be formed separately or integrally.
- the rounded top surface 75 is provided with a small hole 72 for perfusion Liquid flows out of the ablation electrode 17.
- the cylindrical side wall surface 77 is provided with an annular groove 73.
- the arrangement of the annular groove 73 can be set by a person skilled in the art in a conventional manner, for example, in the manner described in U.S. Patent No. US20080294158.
- FIG 10 is a cross-sectional view of the ablation electrode 17 shown in Figure 8.
- the ablation electrode 17 includes a cavity 76, and the proximal end of the electrode housing 71 is provided with an insert 74.
- the insert 74 is disposed at a proximal end of the ablation electrode 17.
- the insert 74 may be cylindrical, disc shaped or other suitable shape including a through hole 81 having a distal end extending into the through hole 79 of the electrode housing 71.
- the extension of the through hole 81 may be integrally formed with the insert 74, or may be formed separately, such as inserting a hollow tube into the through hole 81 or connecting the distal end of the through hole 81. Pipe or other suitable structure.
- the proximal end of the through hole 81 is open at the proximal end of the insert 74, and the distal end of the through hole 81 is open on the outer surface of the electrode housing 71, which is flat with the outer surface of the electrode housing 71. Qi.
- the distal end of the through hole 81 is provided with a temperature sensor 33, and the temperature sensor 33 is fixed by bonding.
- the insert 74 further includes a through hole 80 which is a liquid passage for the perfusion liquid to flow into, which may be a central chamber or an eccentric chamber.
- the non-metallic insulating layer 78 is disposed on the through hole 81.
- the non-metallic insulating layer 78 is disposed on the inner wall and/or the outer wall of the through hole 81.
- the through hole 81 itself can serve as a non-metallic heat insulating layer.
- the non-metallic heat insulation layer 78 is disposed on the inner wall of the through hole 81. And / or the outer wall.
- the through hole 81 itself can serve as a non-metallic insulation layer.
- the non-metallic heat insulating layer 78 may cover the inner wall and/or the outer wall of the through hole 81, or may be partially covered.
- the distal end of the hollow tube in the through hole 80 may also be provided with an extension tube 83, which may be fixed by bonding, welding or other suitable means; the extension tube 83 may also be in the middle
- the empty tube is formed integrally.
- the insert 74 may be entirely disposed within the cavity of the electrode housing 71 or partially within the cavity of the electrode housing 71, as shown in FIG.
- the remaining structure of the catheter 10 can be the same as that shown in Figures 4 and 5, or can be a catheter structure as in U.S. Patent No. 20080294158.
- Figure 11 is a cross-sectional view of the ablation electrode 17 according to still another embodiment of the present invention
- Figure 12 is a cross-sectional view of the ablation electrode 17 of Figure 11 .
- the ablation electrode 17 includes an electrode housing 71 and a cavity 76 therein, and an insert 74 is provided at the proximal end of the electrode housing 71.
- the insert 74 may be circular or other suitable shape such as a cylindrical shape, a disc shape or the like.
- the insert includes a through hole 81, and a distal end of the through hole 81 extends into the through hole 79 of the electrode housing 71.
- the extension of the through hole 81 and the insert 74 may be integrally formed, or may be formed separately, such as inserting a hollow tube into the through hole 81 or connecting the distal end of the through hole 81.
- Pipe or other suitable structure A proximal end of the through hole 81 is open at a proximal end of the insert 74, and a distal end of the through hole 81 is open on an outer surface of the electrode housing 71, and is flat with an outer surface of the electrode housing 71.
- the distal end of the through hole 81 is provided with a temperature sensor 33, and the temperature sensor 33 is fixed by bonding.
- the inner wall of the through hole 81 is also connected with a stainless steel tube, and the distal end of the pulling wire 21 extends into the stainless steel tube and is fixed by welding.
- the perfusion channel has a proximal end and a distal end, the distal end of which extends through the control handle 11, the central chamber 23 of the catheter body 12 into the first eccentric chamber 35 of the elastic tip end tube 31, and ablation
- the liquid passage of the electrode 17 is in communication.
- a perfusion line 26 is provided in the perfusion channel, and the distal end of the perfusion line 26 extends through the control handle 11 to a central cavity of the catheter body 12.
- the distal end of the chamber 23 is in communication with the first eccentric chamber 35 of the resilient tip end tube 31.
- the elastic head end tube 31 may also be a four-chamber or more chamber structure such that the perfusion liquid may flow into the cavity 76 of the electrode housing through at least two eccentric chambers of the elastic head end tube 31. .
- the distal end of the wire 25 is welded to the stainless steel tube, and a sealant is filled at the distal end of the wire and the proximal end of the through hole 81 to avoid direct contact with the perfusion liquid.
- the through hole 81 is provided with a non-metal heat insulation layer 78.
- the non-metal heat insulation layer 78 is provided on the inner wall and/or the outer wall of the through hole 81.
- the through hole 81 itself can serve as a non-metallic insulating layer.
- the non-metallic heat insulation layer 78 is disposed on the inner wall of the through hole 81. And / or the outer wall.
- the remaining structure of the catheter 10 is the same as the embodiment shown in FIG. 4 and FIG. 5, or the embodiment shown in FIG. Example.
- Figure 13 is a cross-sectional view of the ablation electrode 17 in accordance with yet another embodiment of the present invention.
- the ablation electrode 17 includes at least one liquid passage 80 having an opening at the proximal end of the ablation electrode 17, through which the perfusion liquid can flow to the outer surface of the ablation electrode 17.
- the liquid passage has a plurality of branches extending to and opening to the outer surface of the ablation electrode.
- the ablation electrode 17 further includes a through hole 81, and the distal end of the through hole 81 is opened.
- the mouth is flush with the outer surface of the electrode housing 71 on the outer surface of the electrode housing 71.
- the temperature sensor 33 is disposed at the distal end of the through hole 81 and is fixed by bonding.
- the ablation electrode 17 further includes a blind hole 82 in which the pull wire 21 is fixed.
- the through hole 80, the through hole 81, and the blind hole 82 communicate with the first eccentric chamber 35, the second eccentric chamber 36, and the third eccentric chamber 37 of the elastic head end tube 31, respectively.
- the non-metallic insulating layer 78 is provided in whole or in part on the inner wall of the through hole 81.
- the non-metallic insulating layer 78 may be a tubular insulating layer inserted into the through hole 81, or a non-metallic insulating layer may be coated on the inner wall of the through hole 81.
- the non-metallic insulating layer 78 is made of a heat insulating material, may be made of a non-metallic material, such as a polymer material, or may be ceramic or made of other suitable non-metal materials.
- the non-metallic insulating layer 78 may be made of a high temperature resistant non-metallic material.
- a non-metallic insulating layer 78 may also be provided in all or part of the liquid passage 80.
- the remaining structure of the catheter 10 is the same as that of the embodiment shown in Figs. 4 and 5 or the catheter structure described in the Chinese patent CN201020215408.8.
- FIG. 14 is a cross-sectional view of the ablation electrode 17 in accordance with yet another embodiment of the present invention.
- the ablation electrode 17 includes an electrode housing 71 and a cavity 76 therein, and an insert 74 is provided at a proximal end of the electrode housing 71.
- the insert 74 can be cylindrical, disc shaped or other suitable shape including at least a through hole 81, the distal end of which extends into the through hole 79 of the electrode housing 71.
- the extension of the through hole 81 and the insert 74 may be integrally formed, or may be formed separately, such as inserting a hollow tube into the through hole 81 or connecting the distal end of the through hole 81. Pipe or other suitable structure.
- a proximal end of the through hole 81 is open at a proximal end of the insert 74, and a distal end of the through hole 81 extends to an inner surface of the electrode housing 71 to be flat with an inner surface of the electrode housing 71. It is also possible to partially extend into the electrode housing 71.
- the distal end of the through hole 81 is provided with a temperature sensor 33, which is fixed by bonding.
- a hollow tube may be disposed in the through hole 81, and the distal end of the hollow tube extends to the The inner surface of the electrode housing 71 is flush with the inner surface of the electrode housing 71, and may also partially extend into the electrode housing 71.
- the distal end of the hollow tube is a closed structure.
- the temperature sensor 33 is adhesively fixed to the distal end of the hollow tube.
- the electrode housing at the location where the temperature sensor is located has a thickness of less than 0.2 mm.
- the electrode housing at the position where the temperature sensor is located has a thickness of less than 0.1 mm.
- the insert 74 also includes a through hole 80 that is a liquid passage for the perfusion liquid to flow in.
- the through hole 80 and the through hole 81 communicate with the first eccentric chamber 35 and the second eccentric chamber 36 of the elastic head end tube 31, respectively.
- the through hole 81 is provided with a non-metal heat insulation layer 78.
- the non-metal heat insulation layer 78 is provided on the inner wall and/or the outer wall of the through hole 81.
- the through hole 81 itself can serve as a non-metallic insulating layer.
- the non-metallic heat insulation layer 78 is disposed on the inner wall of the through hole 81. And / or the outer wall.
- the temperature sensor 33 may be in direct contact with a portion of the electrode housing that is not directly cooled by the infusion liquid, or may have a connection through a metal material, such as welding, or a connection having a non-metallic heat conductive material.
- the thermal adhesive bonding may also be accompanied by a connection of a metallic material and a connection of a non-metallic thermally conductive material or other suitable joining method. Therefore, the temperature The thermal conductivity between the degree sensor 33 and the outer wall of the electrode housing 71 is better than the thermal conductivity between the temperature sensor 33 and the liquid passage.
- the portion of the electrode housing that is not directly cooled by the perfusion liquid in the present invention refers to a portion of the electrode housing that is not in direct contact with the perfusion liquid.
- the liquid passage described in the present invention includes a portion through which the perfusion liquid flows in the ablation electrode 17, and includes a portion in the bore 80, in the cavity 76 of the electrode housing 17, and on the electrode housing for the perfusion liquid to flow out.
- the remaining structure of the catheter 10 is the same as the embodiment shown in FIG. 4 and FIG. 5, or the embodiment shown in FIG. 9 and FIG.
- the embodiment can also be the same as the other embodiments.
- the embodiments of the present invention are not limited to the above embodiments.
- the form of the electrode body and/or the insert may be changed, such as changing the diameter, adjusting the number of passages, changing the length, etc.
- the cooling and temperature measurement requirements in ablation and the need to connect the ablation electrode to the catheter body are met.
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Abstract
本发明公开了一种用于导管的消融电极,包括电极壳体、电极壳体内的任选的空腔以及温度传感器;所述电极壳体上设有供灌注液体流出的液体通路,所述电极壳体近端设有供灌注液体流入的液体通路;所述温度传感器与液体通路之间设有热传导隔离结构,所述温度传感器所处位置的电极壳体厚度为小于0.2mm。本发明还公开了一种包括上述消融电极的灌注型电极导管。本发明的灌注型电极导管能够对消融过程中的消融温升给予有效的提示。
Description
一种消融电极及采用该电极的灌注型电极导管 相关申请的交叉援引
本申请要求 2012年 3月 23日提交的中国专利申请 201210079501.4的 优先权, 在此通过援引将其全部内容并入本文。 技术领域 本发明涉及一种消融电极及采用该电极的灌注型电极导管,具体的讲, 涉及一种带有温度传感器的消融电极及采用该电极的灌注型电极导管。 背景技术 电极导管广泛应用于临床实践已有多年历史。他们可以被用于在心脏内 部对电活动进行标测、 刺激, 并对存在电活动异常的位置进行消融治疗。
临床使用之中,电极导管通过主要静脉或动脉进入体内,如通过股静脉, 进而导引进入所关注的心腔。 在某些应用中, 还希望导管具有注入和 /或抽 出液体的能力, 灌注型导管即可完成这种功能。
一个具体应用的例子是导管心内消融术在心内生成消融损伤以截断心 内的非正常心电传导路径。 一个典型的消融手术过程包括, 将一个在其远 端具有消融电极的导管***心腔, 提供一个参考电极, 一般贴附固定于患 者的皮肤表面, 射频 (RF) 电压施加于消融电极和参考电极之间, 产生射 频电流流过其间的介质, 包括血液和组织。 电流的分布取决于消融电极与 组织接触面积和与血液接触面积的比。 心脏组织被射频电流热效应充分加 热后, 组织细胞遭到破坏导致在心脏组织中形成损伤, 损伤组织不形成电
传导。 这个过程中, 被加热的组织通过热传导同时发生对消融电极的加热。 如果电极温度足够高, 比如高于 60°C, 电极表面可以形成一层由血液蛋白 脱水形成的薄膜, 如果温度进一步升高, 此脱水蛋白层会渐进增厚, 并导 致电极表面血凝的发生。 由于脱水生物材料电导率低于心内组织, 射频电 流流入组织的阻抗也在提高, 阻抗高到一定程度, 导管就必须取出体外对 消融电极进行清理。
达到前述希望效果的另一种方法是对消融电极进行灌注, 例如采用室温 的生理盐水, 对消融电极进行主动冷却而不是依赖于比较被动的血液的冷 却效应。 这种情况下, 电极得到有效冷却, 表面温度不再是产生阻抗上升 甚至血凝的主要因素, 因此射频电流强度不再受表面温度的限制, 电流可 以加大, 这会导致形成更大、 更趋近于球形的损伤, 通常尺度为 10mm至 12mm。
美国专利 US5,643,197和 US5,462,521中公开了一种使用多孔材料制成 的灌注型电极, 所述电极为微小粒子通过烧结形成的金属结构, 多重互联 的通道使得液体对电极结构的冷却更加有效。 而且, 多孔结构使液流在电 极表面呈均匀分布的液膜, 成为血液和电极表面之间的阻隔层。
因此, 需要一种新型灌注型导管。 发明内容 本发明提供了一种用于导管的消融电极, 包括电极壳体、 电极壳体内 的任选的空腔以及温度传感器; 所述电极壳体上设有供灌注液体流出的液 体通路, 所述电极壳体近端设有供灌注液体流入的液体通路; 所述温度传
感器与液体通路之间设有热传导隔离结构, 所述温度传感器所处位置的电 极壳体厚度为小于 0.2mm。
本文所用的术语 "任选"(optional)表示 "可有可无"或 "非必需"的含 义。 例如, "任选的空腔"是指可以具有该空腔, 也可以没有该空腔。 这可 以由本领域技术人员根据情况进行选择。
在本发明的一种实施方式中, 所述电极壳体上设有一通孔, 所述温度传 感器设于所述通孔内。
在本发明的一个具体实施方式中, 所述电极壳体的近端设有插件, 所述 插件的远端延伸至所述空腔内, 包括至少一个通孔; 所述插件上通孔的远 端延伸至所述电极壳体的通孔内, 其近端开口于所述插件的近端, 远端开 口于所述电极壳体的外表面上, 与电极壳体的外表面平齐, 所述温度传感 器设于所述插件上通孔的远端。
所述电极壳体上通孔的直径可以是小于 lmm;优选的,所述电极壳体上 通孔的直径为小于 0.5mm。
在本发明的一个具体实施方式中, 所述电极壳体的近端设有插件, 所述 插件的远端延伸至所述空腔内, 包括至少一个通孔; 所述插件上通孔的远 端延伸至所述电极壳体的内表面上, 与电极壳体的内表面平齐, 或部分延 伸至所述电极壳体内; 所述插件上通孔的近端开口于所述插件的近端, 远 端为开口或封闭结构, 所述温度传感器设于所述插件上通孔的远端; 优选 的, 所述温度传感器所处位置的电极壳体厚度为小于 0.1mm。
优选的, 所述热传导隔离结构为非金属隔热层。
所述非金属隔热层可以设于所述插件上通孔的内壁和 /或外壁; 优选的,
所述插件上通孔的内壁和 /或外壁上部分或全部设有非金属隔热层。
所述温度传感器感温部分距离温度传感器顶端的距离可以为小于
0.5mm; 优选的, 所述温度传感器感温部分距离温度传感器顶端的距离为 小于 0.2mm; 更为优选的, 所述温度传感器感温部分距离温度传感器顶端 的距离为小于 0.1mm。
所述非金属隔热层可以由高分子材料或陶瓷制成。
本发明提供了一种灌注型电极导管, 其特征在于包括导管主体, 其具有 近端, 远端和贯穿其中的中心腔室;
消融部分, 包括一段弹性头端管, 具有近端、 远端和至少一个贯通的 腔室, 其近端与导管主体的远端固定连接;
消融电极, 固定连接于消融部分的远端, 包括电极壳体、 电极壳体内 的任选的空腔以及温度传感器; 所述电极壳体上设有供灌注液体流出的液 体通路, 所述电极壳体近端设有供灌注液体流入的液体通路; 所述温度传 感器与液体通路之间设有热传导隔离结构, 所述温度传感器所处位置的电 极壳体厚度为小于 0.2mm ;
灌注通道, 具有近端和远端, 其远端通过导管主体的中心腔室延伸进 入消融部分的腔室内, 与消融电极的液体通路连通。
在本发明的一种实施方式中, 所述电极壳体上设有一通孔, 所述温度 传感器设于所述通孔内。
在本发明的一个具体实施方式中, 所述电极壳体的近端设有插件, 所 述插件的远端延伸至所述空腔内, 包括至少一个通孔; 所述插件上通孔的 远端延伸至所述电极壳体的通孔内, 其近端开口于所述插件的近端, 远端
开口于所述电极壳体的外表面上, 与电极壳体的外表面平齐, 所述温度传 感器设于所述插件上通孔的远端。
所述电极壳体上通孔的直径可以小于 lmm; 优选的, 所述电极壳体上 通孔的直径为小于 0.5mm。
在本发明的一个具体实施方式中, 所述电极壳体的近端设有插件, 所 述插件的远端延伸至所述空腔内, 包括至少一个通孔; 所述插件上通孔的 远端延伸至所述电极壳体的内表面上, 与电极壳体的内表面平齐, 或部分 延伸至所述电极壳体内; 所述插件上通孔的近端开口于所述插件的近端, 远端为开口或封闭结构, 所述温度传感器设于所述插件上通孔的远端; 优 选的, 所述温度传感器所处位置的电极壳体厚度为小于 0.1mm。
所述灌注通道内设有灌注管路, 所述灌注管路的远端可以是通过所述 控制手柄、 导管主体的中心腔室延伸到达消融部分的腔室的远端, 与消融 电极的液体通路相连通; 也可以是通过所述控制手柄延伸到达导管主体的 中心腔室的远端, 与消融部分的至少一个贯通的腔室相连通。
优选的, 所述热传导隔离结构为非金属隔热层。 所述非金属隔热层可以设于所述插件上通孔的内壁和 /或外壁;优选的, 所述插件上通孔的内壁和 /或外壁上部分或全部设有非金属隔热层。
所述温度传感器感温部分距离温度传感器顶端的距离可以为小于 0.5mm; 优选的, 所述温度传感器感温部分距离温度传感器顶端的距离为 小于 0.2mm; 更为优选的, 所述温度传感器感温部分距离温度传感器顶端 的距离为小于 0.1mm。
所述非金属隔热层可以由高分子材料或陶瓷制成。
在本发明的一个优选的实施方式中, 所述灌注型电极导管包括热传导隔 离结构, 使得温度传感器与灌注液体冷却效应区隔, 灌注液体对温度传感 器所处部位的冷却效应被削弱, 周边来自电极壳体外壁的热传导对温度传 感器所处部位的加热效应得以保持; 并且所述温度传感器设于所述电极壳 体的内表面或电极壳体的通孔内或部分延伸进入电极壳体内; 因此, 温度 传感器可检测到更多射频电流加热效应产生的温度升高。
附图说明
图 1是根据本发明的灌注型电极导管的结构示意图;
图 2所示的是根据本发明的优选实施方式的导管主体 12的剖视图, 表 示导管主体 12与消融部分 13的连接关系;
图 3所示的是沿图 1 A-A线的剖视图;
图 4所示的是沿图 3中 B-B线的剖视图;
图 5所示的是沿图 3中 C-C线的剖视图;
图 6所示的是根据本发明的优选实施方式的消融电极 17中温度传感器 33的示意图;
图 7 所示的是根据本发明的又一优选实施方式的消融电极 17 的剖视 图;
图 8 所示的是根据本发明的又一优选实施方式的消融电极 17 的结构 图;
图 9所示的是根据图 8所示的消融电极 17的剖视图;
图 10所示的是根据本发明的又一优选实施方式的消融电极 17的剖视 图;
图 11所示的是根据图 10中的消融电极 17的剖视图。
图 12所示的是根据本发明的又一优选实施方式的消融电极 17的剖视 图;
图 13所示的是根据本发明的又一优选实施方式的消融电极 17的剖视 图;
图 14所示的是根据本发明的又一优选实施方式的消融电极 17的剖视 图。
具体实施方式
下面通过实施方式, 并结合附图, 对本发明的技术方案作进一步详细 的说明, 但本发明不仅仅限于下面的实施方式。
图 1所示的是本发明的一种带有温度传感器的灌注型电极导管 10的结 构示意图, 包括导管主体 12, 其具有远端和近端, 在所述导管主体 12的远 端设有消融部分 13, 在所述导管主体 12的近端设有控制手柄 11。
图 2所示的是根据本发明的一种实施方式的导管主体 12的剖视图, 表 示导管主体 12与消融部分 13的连接关系;所述导管主体 12包括加强管 22 和套于其外部的主体管 28,所述的主体管 28可由生物相容性的高分子材料 制成,例如由聚醚嵌段酰胺、聚氨酯或尼龙材料制成, 其管壁内优选的包括 至少一层金属丝编织层 (图中未示出), 可以是不锈钢丝编织层, 所述金属 丝编织层可以是一层、 两层或更多; 所述加强管 22包括中心腔室 23, 所述 加强管 22可由任何合适的高分子材料制成,例如由聚醚嵌段酰胺、聚氨酯、 聚酰亚胺或尼龙材料挤出成型; 所述导管主体优选为细长、 可弯曲, 但是 在其长度方向上通常不可压缩, 所述中心腔室 23在导管主体 12的轴向延
伸; 导线 25、 牵引线 21和灌注管路 26在所述的中心腔室 23内延伸。
所述消融部分 13包括弹性头端管 31,其可由生物相容性材料制成, 包 括远端、 近端以及至少一个腔室, 所述腔室可以是中心腔室或偏心腔室。 如图 2所示, 在本发明的一个具体实施方式中, 所述弹性头端管 31包括第 一偏心腔室 35、 第二偏心腔室 36和第三偏心腔室 37, 优选的, 所述弹性 头端管 31 的管壁内包括至少一层金属丝编织层 (图中未示出), 可以是不 锈钢丝编织层, 所述金属丝编织层可以是一层、 两层或更多。
优选的, 所述弹性头端管 31的近端为磨细端 34, 如图 2所示, 其外径 与导管主体 12的内径相配合, 将所述磨细端 34***导管主体 12中, 其可 以通过粘接、 焊接或其它合适的方式进行固定, 例如通过紫外线固化胶将 其与导管主体 12粘接固定。
图 3所示的是沿图 1中 A-A线的剖视图, 图 4所示的是沿图 3中 B-B 线的剖视图, 图 5所示的是沿图 3中 C-C线的剖视图, 图 6所示的是图 4 和图 5中所示温度传感器 33的示意图。 在所述弹性头端管 31的远端设有 消融电极 17, 在沿着弹性头端管 31的长度方向上设有环电极 16, 其数量 可以根据实际需要而不同, 可以没有环电极, 也可以是一个、 两个、 三个、 四个或更多。 所述消融电极 17包括电极壳体 71以及其内部的空腔 76。 所 述电极壳体 71上还设有通孔 79, 所述通孔 79的直径小于 1mm; 优选的, 所述通孔 79的直径小于 0.5mm。 所述电极壳体 71的外表面是可以与消融 组织接触的部分; 所述电极壳体 71内部的空腔是不能与组织接触的部分。
在一种优选的实施方式中, 如图 4和图 5所示, 所述空腔 76内设有插 件 74, 所述插件 74设于所述电极壳体 71的近端, 其远端延伸至所述空腔
76内。所述插件 74可以是圆柱形、 圆盘形或其它合适的形状, 其至少包括 通孔 81, 所述通孔 81的远端延伸至所述电极壳体 71的通孔 79内。所述通 孔 81的延伸段与所述插件 74可以是一体构成, 也可以是分体构成, 如在 所述通孔 81 内***中空管, 或在所述通孔 81 的远端连接有管路或其它合 适的结构。 所述通孔 81的近端开口于所述插件 74的近端, 所述通孔 81的 远端开口于所述电极壳体 71 的外表面上, 与所述电极壳体 71的外表面平 齐。 所述通孔 81的远端设有温度传感器 33, 所述温度传感器 33通过粘接 固定。 所述温度传感器 33所处位置为电极壳体上的通孔, 此处电极壳体厚 度为零。 所述通孔 81 的位置可以是靠近所述电极壳体 71 的轴线位置, 也 可以是靠近所述电极壳体 71 的侧壁。 所述插件还包括通孔 80, 所述通孔 80是供灌注液体流入的液体通路。
如图 6所示, 所述温度传感器 33外部套有外套管 332, 所述外套管由 绝缘或绝缘绝热材料制成。所述温度传感器 33的感温部分 331与温度传感 器顶端之间的距离为小于 0.5mm; 优选的, 所述温度传感器感温部分距离 温度传感器顶端的距离为小于 0.2mm; 更为优选的, 所述温度传感器感温 部分距离温度传感器顶端的距离为小于 0.1mm所述感温部分 331与顶端之 间可以设有绝缘导热胶 333, 这样可以提高温度传感器的灵敏度, 同时提供 足够的绝缘性。所述温度传感器 33的顶端可以与所述电极壳体的外表面平 齐, 也可以是位于所述电极壳体的外表面附近, 如所述温度传感器 33的顶 端小部分突出至外表面外, 或小部分縮至外表面内。
所述插件 74还包括盲孔 82, 其内固定有牵引线 21。 所述通孔 80, 通 孔 81和盲孔 82分别与弹性头端管 31的第一偏心腔室 35、 第二偏心腔室
36和第三偏心腔室 37相连通。 优选的, 可以在所述插件 74的三个孔 80, 81, 82上分别焊接或粘接有中空管, 其可由合适的高分子材料或金属材料 构成, 如聚酰亚胺或不锈钢。
所述温度传感器 33与所述液体通路之间设有热传导隔离结构, 所述热 传导隔离结构为非金属隔热层 78, 其设于所述通孔 81上。 当所述通孔 81 的延伸段与所述插件 74—体构成时, 当所述插件 74为金属材料时, 所述 非金属隔热层 78设于所述通孔 81 的内壁和 /或外壁。 本文中所述通孔 81 的内壁和 /或外壁可以是指在所述空腔中延伸的一段通孔 81 的内壁和 /或外 壁, 也可以是指整个通孔 81的内壁和 /或外壁。 所述非金属隔热层 78可以 是管状隔热层, ***所述通孔 81 的内壁和 /或外壁, 也可以是在所述通孔 81 的内壁和 /或外壁上涂覆非金属隔热层。 所述插件 74为非金属材料时, 所述通孔 81本身即可作为非金属隔热层。 当所述通孔 81 的延伸段与所述 插件 74分体构成时, 当所述通孔 81 的延伸段为金属材料时, 所述非金属 隔热层 78设于所述通孔 81的内壁和 /或外壁。所述插件通孔 81的延伸段为 非金属材料时, 所述通孔 81本身即可作为非金属隔热层。
所述非金属隔热层 78可以是全部覆盖所述通孔 81的内壁和 /或外壁, 也可以是部分覆盖。 当所述非金属隔热层 78部分覆盖时, 可以对热隔离程 度进行调整, 以调节温度传感器 33所测到的温度。 当改变非金属隔热层的 材料或其厚度时, 也可以对热隔离程度进行调整。 所述非金属隔热层 78由 具有隔热功能的非金属材料制成, 可以是高分子材料制成, 也可以是陶瓷 制成或由其它合适的非金属材料制成。 所述非金属隔热层 78可以采用耐高 温的非金属材料制成。 由于在所述通孔 81上设有非金属隔热层 78,使得温
度传感器与灌注液体冷却效应相区隔, 灌注液体对温度传感器所处部位的 冷却效应被削弱, 温度传感器将可检测到更多射频电流加热效应产生的温 度升高。
所述插件 74可以全部置于所述电极壳体 71的空腔内, 也可以部分置 于所述电极壳体 71的空腔内, 如图 7所示。
所述温度传感器 33可以是热电偶、 热敏电阻或其它; 所述温度传感器 的数量可以是一个、 两个、 三个或更多, 如图 4所示, 所述温度传感器 33 的远端通过导管主体 12的中心腔室 23延伸至弹性头端管 31的第二偏心腔 室 36内, 然后延伸进入所述通孔 81内, 通过粘接固定在所述通孔 81的远 端。所述温度传感器 33的近端通过中心腔室 23延伸进入所述控制手柄 11, 并从所述控制手柄 11延伸出来, 与温度监测装置相连 (图中未示出)。
所述的电极壳体 71 上设有若干小孔 (图中未示出), 作为供灌注液体 流出的液体通路。 所述小孔可以通过任何合适的方式进行设置, 可以是采 用机械、 激光或电加工等方式设置, 也可以采用多孔材料制成。
灌注通道, 具有近端和远端, 其远端通过控制手柄 11、 导管主体 12的 中心腔室 23延伸进入弹性头端管 31的第一偏心腔室 35内,与消融电极 17 的液体通路连通。 在所述灌注通道内设有灌注管路 26, 所述的灌注管路 26 的远端可以是通过所述控制手柄 11、 导管主体 12的中心腔室 23延伸到达 弹性头端管 31的第一偏心腔室 35的远端, 与消融电极 17的液体通路相连 通; 也可以是通过所述控制手柄 11延伸到达导管主体 12的中心腔室 23的 远端, 与弹性头端管 31的第一偏心腔室 35相连通。
所述灌注管路 26可由任何合适的材料制成, 其远端通过导管主体 12的
中心腔室 23延伸至弹性头端管 31 的第一偏心腔室 35内, 与所述插件 74 上的通孔 80相贯通。 灌注管路 26的近端通过导管主体 12的中心腔室 23 延伸至所述控制手柄 11内, 其固定方法可以采用本领域技术人员熟知的任 何适合的方法进行固定, 例如在所述灌注管路 26的近端连接一段支管 14, 如图 1所示, 其延伸至所述控制手柄 11外部, 端部与鲁尔接头 15连接固 定。
灌注液体, 可以是任何合适的液体, 例如生理盐水, 其通过所述支管 14进入所述灌注管路 26内,并通过所述灌注管路 26以及通孔 80进入所述 消融电极 17的空腔 76内, 通过所述电极壳体上的孔流至所述导管 10的外 部。
牵引线 21, 优选由不锈钢或镍钛合金制成, 如图 2和图 3和图 5所示, 其远端通过中心腔室 23延伸至弹性头端管 31的第三偏心腔室 37内, 在导 管主体 12内延伸的一段牵引线 21, 优选的, 其外部套有弹簧管 29, 所述 弹簧管 29优选为带收紧力的紧密结构, 其外部套有第二保护套管 (图中未 示出), 所述第二保护套管可由任何合适的材料制成, 优选由聚酰胺材料制 成, 用于所述弹簧管 29在其内延伸; 所述第二保护套管的远端和近端可以 通过粘接、 焊接或其它合适的方式固定到所述弹簧管 29上, 例如通过紫外 线固化胶粘接到所述弹簧管 29上; 如图 5所示, 在所述弹性头端管 31 内 延伸的一段牵引线 21, 优选的, 其外部套有第一保护套管 32, 所述第一保 护套管 32可由任何合适的材料制成, 优选由聚四氟乙烯材料制成, 其设于 所述弹性头端管 31内, 用于所述牵引线 21在其内延伸。
如图 5所示,所述牵引线 21的远端延伸进入所述插件 74上的孔 82内,
其端部通过焊接、 粘接或其它合适的方式固定, 优选通过焊接进行固定。 所述牵引线 21 的近端固定到所述控制手柄 11上, 其固定方法可以采 用本领域技术人员熟知的任何适合的方法进行固定。 例如己公开的美国专 利 US6120476中披露的牵引线的固定方法。
导线 25, 如图 2和图 3和图 4所示, 其远端通过中心腔室 23延伸至弹 性头端管 31的第二偏心腔室 36内, 分别与消融电极 17、环电极 16以及温 度传感器 33连接, 其连接方式为焊接或其它合适的方式, 优选通过悍接固 定。 优选的, 在所述导线 25的外部设有护线管 27。
导线 25的近端固定到所述控制手柄 11上, 其固定方法可以采用本领 域技术人员熟知的任何适合的方法进行固定, 例如通过悍接固定到相应的 插头上。
在本发明的一种具体实施方式中, 在所述消融电极 17进行消融的过程 中, 由于所述插件 74的通孔 81上设有非金属隔热层 78, 以及所述温度传 感器 33可以设于所述电极壳体 71的内表面或电极壳体 71的通孔内或部分 设于电极壳体内, 在采用同样临床常用的导管射频消融功率及灌注条件下, 本发明的消融电极测到的温度更接近组织温度。 其中, 根据本发明的一种 优选的具体实施方式, 所述温度传感器 33设于所述电极壳体 71的内表面, 更为优选的, 所述温度传感器 33部分设于电极壳体 71 内, 特别优选的, 所述温度传感器 33设于所述电极壳体 71的通孔内。
图 8是根据本发明的又一个实施方式的所述消融电极 17的剖视图。如 图 8所示, 所述消融电极 17包括电极壳体 71及其内部的空腔 76, 插件 74 设于所述电极壳体 71 的近端。 所述插件 74可以是圆柱形、 圆盘形或其它
合适的形状,其至少包括通孔 81, 所述通孔 81的远端延伸至所述电极壳体 71的通孔 79内。所述通孔 81的延伸段与所述插件 74可以是一体构成, 也 可以是分体构成, 如在所述通孔 81 内***中空管, 或在所述通孔 81的远 端连接有管路或其它合适的结构。 所述通孔 81 的近端开口于所述插件 74 的近端, 所述通孔 81的远端在所述空腔 76内转折延伸至所述电极壳体 71 的侧壁上的通孔 79内, 并开口于侧壁上, 与所述电极壳体 71 的外表面平 齐, 如图 8所示。所述通孔 81的远端设有温度传感器 33, 所述温度传感器 33通过粘接固定。 所述插件 74还包括通孔 80, 所述通孔 80为液体通路, 供灌注液体流入。 所述通孔 80和通孔 81分别与弹性头端管 31的第一偏心 腔室 35和第二偏心腔室 36相连通。
所述通孔 81上设有非金属隔热层 78, 当所述通孔 81的延伸段与所述 插件 74—体构成时, 当所述插件 74为金属材料时, 所述非金属隔热层 78 设于所述通孔 81的内壁和 /或外壁。 所述插件 74为非金属材料时, 所述通 孔 81本身即可作为非金属隔热层。 当所述通孔 81的延伸段与所述插件 74 分体构成时, 当所述通孔 81的延伸段为金属材料时, 所述非金属隔热层 78 设于所述通孔 81的内壁和 /或外壁。 所述插件通孔 81的延伸段为非金属材 料时, 所述通孔 81本身即可作为非金属隔热层。
图 8所示的实施例, 所述导管 10的其余结构同图 4和图 5所示的实施 例。
图 9所示的是根据本发明的又一实施方式的消融电极 17的结构图。 所 述消融电极 17包括圆柱形侧壁面 77和圆滑顶面 75,所述消融电极 17可以 是分体形成, 也可以是一体形成。 所述圆滑顶面 75上设有小孔 72, 供灌注
液体流出所述消融电极 17。 所述圆柱形侧壁面 77上设有环形沟槽 73, 所 述环形沟槽 73的设置, 本领域技术人员可以采用常规的方式进行设置, 例 如可以采用美国专利 US20080294158中所述的方式进行设置。
图 10所示的是根据图 8所示的消融电极 17的剖视图。 所述消融电极 17包括一个空腔 76, 所述电极壳体 71的近端设有插件 74。所述插件 74设 于所述消融电极 17的近端。 所述插件 74可以是圆柱形、 圆盘形或其它合 适的形状, 包括通孔 81, 所述通孔 81的远端延伸至所述电极壳体 71的通 孔 79内。 所述通孔 81的延伸段与所述插件 74可以是一体构成, 也可以是 分体构成, 如在所述通孔 81 内***中空管, 或在所述通孔 81 的远端连接 有管路或其它合适的结构。所述通孔 81的近端开口于所述插件 74的近端, 所述通孔 81的远端开口于所述电极壳体 71 的外表面上, 与所述电极壳体 71 的外表面平齐。 所述通孔 81 的远端设有温度传感器 33, 所述温度传感 器 33通过粘接固定。所述插件 74还包括通孔 80,所述通孔 80是供灌注液 体流入的液体通路, 其可以是中心腔室, 也可以是偏心腔室。
所述非金属隔热层 78, 设于所述通孔 81上。 当所述通孔 81的延伸段 与所述插件 74—体构成时, 当所述插件 74为金属材料时, 所述非金属隔 热层 78设于所述通孔 81的内壁和 /或外壁。 所述插件 74为非金属材料时, 所述通孔 81本身即可作为非金属隔热层。 当所述通孔 81 的延伸段与所述 插件 74分体构成时, 当所述通孔 81的延伸段为金属材料时, 所述非金属 隔热层 78设于所述通孔 81的内壁和 /或外壁。所述插件通孔 81的延伸段为 非金属材料时, 所述通孔 81本身即可作为非金属隔热层。 所述非金属隔热 层 78可以是全部覆盖所述通孔 81的内壁和 /或外壁, 也可以是部分覆盖。
优选的, 所述通孔 80内的中空管的远端也可以设有延长管 83, 其可以通过 粘接、 焊接或其它合适的方式进行固定; 所述延长管 83也可以与所述中空 管一体形成。 所述插件 74可以全部置于所述电极壳体 71 的空腔内, 也可 以部分置于所述电极壳体 71的空腔内, 如图 10所示。
图 9和图 10所示的实施方式, 所述导管 10的其余结构可以同图 4和 图 5所示的实施例, 也可以是如美国专利 US20080294158中的导管结构。
图 11所示的是根据本发明的又一实施方式的所述消融电极 17的剖视 图; 图 12所示的是图 11中所述消融电极 17的剖视图。 如图 11和图 12所 示, 所述消融电极 17包括电极壳体 71及其内部的空腔 76,插件 74设于所 述电极壳体 71 的近端。 所述插件 74可以是圆环形也可以是其它合适的形 状, 如圆柱形, 圆盘形等。 所述插件包括通孔 81, 所述通孔 81的远端延伸 至所述电极壳体 71的通孔 79内。 所述通孔 81的延伸段与所述插件 74可 以是一体构成, 也可以是分体构成, 如在所述通孔 81内***中空管, 或在 所述通孔 81 的远端连接有管路或其它合适的结构。 所述通孔 81的近端开 口于所述插件 74的近端, 所述通孔 81的远端开口于所述电极壳体 71的外 表面上, 与所述电极壳体 71 的外表面平齐。 所述通孔 81 的远端设有温度 传感器 33, 所述温度传感器 33通过粘接固定。 所述通孔 81的内壁还悍接 有不锈钢管,牵引线 21的远端延伸至所述不锈钢管内,通过焊接进行固定。
如图 11所示, 灌注通道, 具有近端和远端, 其远端通过控制手柄 11、 导管主体 12的中心腔室 23延伸进入弹性头端管 31的第一偏心腔室 35内, 与消融电极 17的液体通路连通。在所述灌注通道内设有灌注管路 26,所述 的灌注管路 26的远端通过所述控制手柄 11延伸到达导管主体 12的中心腔
室 23的远端, 与所述弹性头端管 31的第一偏心腔室 35相连通。 所述弹性 头端管 31 的第一偏心腔室 35 内没有灌注管路, 灌注液体直接从第一偏心 腔室 35以及通孔 81进入所述电极壳体 71的空腔 76内。 所述弹性头端管 31还可以为四腔室或更多腔室结构, 这样灌注液体可以通过所述弹性头端 管 31的至少两个偏心腔室流入所述电极壳体的空腔 76内。
导线 25的远端焊接在所述不锈钢管上, 并且在所述导线的远端以及所 述通孔 81的近端填充有密封胶, 避免与灌注液体直接接触。
所述通孔 81上设有非金属隔热层 78, 当所述通孔 81的延伸段与所述 插件 74—体构成时, 当所述插件 74为金属材料时, 所述非金属隔热层 78 设于所述通孔 81的内壁和 /或外壁。 所述插件 74为非金属材料时, 所述通 孔 81本身即可作为非金属隔热层。 当所述通孔 81的延伸段与所述插件 74 分体构成时, 当所述通孔 81的延伸段为金属材料时, 所述非金属隔热层 78 设于所述通孔 81的内壁和 /或外壁。 所述插件通孔 81的延伸段为非金属材 料时, 所述通孔 81本身即可作为非金属隔热层。
图 11和图 12所示的实施例, 所述导管 10的其余结构同图 4和图 5所 示的实施例, 或图 8所示的实施例, 也可以同图 9、 图 10所示的实施例。
图 13示的是根据本发明的又一实施方式的所述消融电极 17的剖视图。 如图 13示, 所述消融电极 17包括至少一个液体通路 80, 所述液体通路 80 在消融电极 17的近端有开口, 灌注液体可以通过液体通路 80流至消融电 极 17的外表面。 灌注液体流过消融电极的途径可以有多种, 例如, 液体通 路有多个分支延伸至并开口于消融电极外表面。
如图 13所示,所述消融电极 17还包括通孔 81,所述通孔 81的远端开
口于所述电极壳体 71 的外表面上, 与所述电极壳体 71 的外表面平齐。 所 述温度传感器 33设于所述通孔 81远端, 通过粘接固定。 所述消融电极 17 还包括一盲孔 82, 牵引线 21固定于所述盲孔 82内。所述通孔 80、通孔 81 和盲孔 82分别与弹性头端管 31的第一偏心腔室 35、第二偏心腔室 36和第 三偏心腔室 37相连通。
所述非金属隔热层 78, 全部或部分设于所述通孔 81的内壁。所述非金 属隔热层 78可以是管状隔热层, ***所述通孔 81 内, 也可以是在所述通 孔 81 内壁上涂覆非金属隔热层。 所述非金属隔热层 78由隔热功能的材料 制成, 可以是非金属材料制成, 如高分子材料制成, 也可以是陶瓷或由其 它合适的非金属材料制成。所述非金属隔热层 78可以采用耐高温的非金属 材料制成。 所述液体通路 80内也可以全部或部分设有非金属隔热层 78。
图 13示的实施方式, 所述导管 10的其余结构同图 4和图 5所示的实 施方式或同中国专利 CN201020215408.8中所述的导管结构。
图 14是根据本发明的又一个实施方式的所述消融电极 17的剖视图。 如图 14所示, 所述消融电极 17包括电极壳体 71及其内部的空腔 76, 插件 74设于所述电极壳体 71的近端。 所述插件 74可以是圆柱形、 圆盘形 或其它合适的形状, 其至少包括通孔 81, 所述通孔 81的远端延伸至所述电 极壳体 71的通孔 79内。 所述通孔 81的延伸段与所述插件 74可以是一体 构成, 也可以是分体构成, 如在所述通孔 81内***中空管, 或在所述通孔 81的远端连接有管路或其它合适的结构。所述通孔 81的近端开口于所述插 件 74的近端, 所述通孔 81的远端延伸至所述电极壳体 71的内表面上, 与 所述电极壳体 71的内表面平齐, 也可以部分延伸进入所述电极壳体 71内。
所述通孔 81的远端设有温度传感器 33,所述温度传感器 33通过粘接固定。 在本实施方式中, 所述插件 74与所述通孔 81 的延伸段为分体结构时, 所 述通孔 81内可以设有一根中空管, 所述中空管的远端延伸至所述电极壳体 71的内表面上, 与所述电极壳体 71的内表面平齐, 也可以部分延伸进入所 述电极壳体 71 内, 所述中空管的远端为封闭结构。 所述温度传感器 33粘 接固定于所述中空管的远端。 所述温度传感器所处位置的电极壳体厚度为 小于 0.2mm。 优选的, 所述温度传感器所处位置的电极壳体厚度为小于 0.1mm。
所述插件 74还包括通孔 80, 所述通孔 80为液体通路, 供灌注液体流 入。 所述通孔 80和通孔 81分别与弹性头端管 31的第一偏心腔室 35和第 二偏心腔室 36相连通。
所述通孔 81上设有非金属隔热层 78, 当所述通孔 81的延伸段与所述 插件 74—体构成时, 当所述插件 74为金属材料时, 所述非金属隔热层 78 设于所述通孔 81的内壁和 /或外壁。 所述插件 74为非金属材料时, 所述通 孔 81本身即可作为非金属隔热层。 当所述通孔 81的延伸段与所述插件 74 分体构成时, 当所述通孔 81的延伸段为金属材料时, 所述非金属隔热层 78 设于所述通孔 81的内壁和 /或外壁。 所述插件通孔 81的延伸段为非金属材 料时, 所述通孔 81本身即可作为非金属隔热层。
所述温度传感器 33与所述电极壳体未被灌注液体直接冷却的部分之间 可以是直接接触, 也可以是具有通过金属材料的连接, 如焊接, 也可以是 具有非金属导热材料的连接, 如导热胶粘接, 还可以存在同时通过金属材 料的连接和非金属导热材料的连接或其它合适的连接方法。 因此, 所述温
度传感器 33与所述电极壳体 71 的外壁之间的热传导性要好于所述温度传 感器 33与所述液体通路之间的热传导性。本发明中所述电极壳体未被灌注 液体直接冷却的部分是指电极壳体上不与灌注液体直接接触的部分。 本发 明中所述的液体通路包括灌注液体在所述消融电极 17内流经的部分, 包括 孔 80内、电极壳体 17的空腔 76内以及电极壳体上供灌注液体流出的部分。
图 14所示的实施例, 所述导管 10的其余结构同图 4和图 5所示的实 施例,或图 9和图 10所示的实施例,也可以同图 11和图 12所示的实施例, 也可以与其它实施例相同。
本发明的实施方式并不限于上述实施例所述, 为满足其它液体通路要 求或机械结构要求, 可以改变电极体和 /或插件的形式, 如改变直径、 调整 通路的数目、 改变长度等, 来满足消融中的冷却和测温需要和消融电极与 导管主体连接的要求。 在不偏离本发明的精神和范围的情况下, 本领域普 通技术人员在形式和细节上对本发明做出的各种改变和改进, 均被认为落 入了本发明的保护范围。
Claims
1.一种用于导管的消融电极, 其特征在于包括电极壳体、 电极壳体内的任选 的空腔以及温度传感器; 所述电极壳体上设有供灌注液体流出的液体通 路, 所述电极壳体近端设有供灌注液体流入的液体通路; 所述温度传感器 与液体通路之间设有热传导隔离结构, 所述温度传感器所处位置的电极壳 体厚度为小于 0.2mm。
2. 根据权利要求 1所述的消融电极, 其特征在于所述电极壳体上设有一通 孔, 所述温度传感器设于所述通孔内。
3. 根据权利要求 1或 2所述的消融电极, 其特征在于所述电极壳体的近端 设有插件, 所述插件的远端延伸至所述空腔内, 包括至少一个通孔; 所述 插件上通孔的远端延伸至所述电极壳体的通孔内, 其近端开口于所述插件 的近端,远端开口于所述电极壳体的外表面上,与电极壳体的外表面平齐, 所述温度传感器设于所述插件上通孔的远端。
4.根据权利要求 2或 3所述的消融电极,其特征在于所述电极壳体上通孔的 直径小于 lmm; 优选的, 所述电极壳体上通孔的直径为小于 0.5mm。
5. 根据权利要求 1所述的消融电极, 其特征在于所述电极壳体的近端设有 插件, 所述插件的远端延伸至所述空腔内, 包括至少一个通孔; 所述插件 上通孔的远端延伸至所述电极壳体的内表面上, 与电极壳体的内表面平 齐, 或部分延伸至所述电极壳体内; 所述插件上通孔的近端开口于所述插 件的近端, 远端为开口或封闭结构, 所述温度传感器设于所述插件的通孔 的远端;优选的,所述温度传感器所处位置的电极壳体厚度为小于 0.1mm。
6.根据上述任一项权利要求所述的消融电极,其特征在于所述热传导隔离结 构为非金属隔热层。 ,
7. 根据权利要求 6所述的消融电极, 其特征在于所述非金属隔热层设于所 述插件上通孔的内壁和 /或外壁; 优选的, 所述插件上通孔的内壁和 /或外 壁上部分或全部设有非金属隔热层。
8. 根据上述任一项权利要求所述的消融电极, 其特征在于所述温度传感器 感温部分距离温度传感器顶端的距离为小于 0.5mm; 优选的, 所述温度传 感器感温部分距离温度传感器顶端的距离为小于 0.2mm; 更为优选的, 所 述温度传感器感温部分距离温度传感器顶端的距离为小于 0.1mm。
9. 根据上述任一项权利要求所述的消融电极, 其特征在于所述非金属隔热 层由高分子材料或陶瓷制成。
10. 一种灌注型电极导管, 其特征在于包括导管主体, 其具有近端, 远端和 贯穿其中的中心腔室;
消融部分, 包括一段弹性头端管, 具有近端、 远端和至少一个贯通的 腔室, 其近端与导管主体的远端固定连接;
消融电极, 固定连接于消融部分的远端, 包括电极壳体、 电极壳体内 的任选的空腔以及温度传感器; 所述电极壳体上设有供灌注液体流出的 液体通路, 所述电极壳体近端设有供灌注液体流入的液体通路; 所述温 度传感器与液体通路之间设有热传导隔离结构, 所述温度传感器所处位 置的电极壳体厚度为小于 0.2mm;
灌注通道, 具有近端和远端, 其远端通过导管主体的中心腔室延伸进 入消融部分的腔室内, 与消融电极的液体通路连通。
11.根据权利要求 10所述的灌注型电极导管,其特征在于所述电极壳体上设 有一通孔, 所述温度传感器设于所述通孔内。
12. 根据权利要求 10或 11所述的灌注型电极导管,其特征在于所述电极壳 体的近端设有插件, 所述插件的远端延伸至所述空腔内, 包括至少一个通 孔; 所述插件上通孔的远端延伸至所述电极壳体的通孔内, 其近端开口于 所述插件的近端, 远端幵口于所述电极壳体的外表面上, 与电极壳体的外 表面平齐, 所述温度传感器设于所述插件的通孔的远端。
13.根据权利要求 11或 12所述的灌注型电极导管, 其特征在于所述电极壳 体上通孔的直径小于 1mm; 优选的, 所述电极壳体上通孔的直径为小于 0.5mm。
14. 根据权利要求 10所述的灌注型电极导管, 其特征在于所述电极壳体的 近端设有插件, 所述插件的远端延伸至所述空腔内, 包括至少一个通孔; 所述插件上通孔的远端延伸至所述电极壳体的内表面上, 与电极壳体的内 表面平齐, 或部分延伸至所述电极壳体内; 所述插件上通孔的近端开口于 所述插件的近端, 远端为开口或封闭结构, 所述温度传感器设于所述插件 的通孔的远端; 优选的, 所述温度传感器所处位置的电极壳体厚度为小于 0.1mm。
15. 根据上述任一项权利要求所述的灌注型电极导管,其特征在于所述灌注 通道内设有灌注管路, 所述灌注管路的远端可以是通过所述控制手柄、 导 管主体的中心腔室延伸到达消融部分的腔室的远端, 与消融电极的液体通 路相连通; 也可以是通过所述控制手柄延伸到达导管主体的中心腔室的远 端, 与消融部分的至少一个贯通的腔室相连通。
16. 根据上述任一项权利要求所述的灌注型电极导管,其特征在于所述热传 导隔离结构为非金属隔热层。
17. 根据权利要求 16所述的灌注型电极导管, 其特征在于所述非金属隔热 层设于所述插件上通孔的内壁和 /或外壁;优选的,所述插件上通孔的内壁 和 /或外壁上部分或全部设有非金属隔热层。
18. 根据上述任一项权利要求所述的灌注型电极导管,其特征在于所述温度 传感器感温部分距离温度传感器顶端的距离为小于 0.5mm; 优选的, 所述 温度传感器感温部分距离温度传感器顶端的距离为小于 0.2mm; 更为优选 的, 所述温度传感器感温部分距离温度传感器顶端的距离为小于 0.1mm。
19. 根据上述任一项权利要求所述的灌注型电极导管,其特征在于所述非金 属隔热层由高分子材料或陶瓷制成。
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CN201380015051.5A CN104220018B (zh) | 2012-03-23 | 2013-03-22 | 一种消融电极及采用该电极的灌注型电极导管 |
EP13765068.5A EP2829249A4 (en) | 2012-03-23 | 2013-03-22 | ABLATION ELECTRODE AND PERFUSION ELECTRODE CATHETER THEREWITH |
US14/492,833 US20150025526A1 (en) | 2012-03-23 | 2014-09-22 | Ablation electrode and perfused electrode catheter using the electrode |
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Also Published As
Publication number | Publication date |
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CN104220018A (zh) | 2014-12-17 |
US20150025526A1 (en) | 2015-01-22 |
CN104220018B (zh) | 2018-02-27 |
EP2829249A4 (en) | 2015-11-18 |
EP2829249A1 (en) | 2015-01-28 |
CN103315808A (zh) | 2013-09-25 |
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