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WO2023125429A1 - 神经消融装置 - Google Patents

神经消融装置 Download PDF

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Publication number
WO2023125429A1
WO2023125429A1 PCT/CN2022/141979 CN2022141979W WO2023125429A1 WO 2023125429 A1 WO2023125429 A1 WO 2023125429A1 CN 2022141979 W CN2022141979 W CN 2022141979W WO 2023125429 A1 WO2023125429 A1 WO 2023125429A1
Authority
WO
WIPO (PCT)
Prior art keywords
mesh
area
support body
ablation device
nerve ablation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2022/141979
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English (en)
French (fr)
Inventor
胡龙虎
石玥
李安宁
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shenzhen Lifetech Respiration Scientific Co Ltd
Original Assignee
Shenzhen Lifetech Respiration Scientific Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shenzhen Lifetech Respiration Scientific Co Ltd filed Critical Shenzhen Lifetech Respiration Scientific Co Ltd
Priority to US18/725,037 priority Critical patent/US20250057583A1/en
Priority to EP22914683.2A priority patent/EP4458301A4/en
Publication of WO2023125429A1 publication Critical patent/WO2023125429A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • 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
    • A—HUMAN NECESSITIES
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    • 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
    • A—HUMAN NECESSITIES
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    • A61B18/14—Probes or electrodes therefor
    • A61B18/1485—Probes or electrodes therefor having a short rigid shaft for accessing the inner body through natural openings
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    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00017—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids with gas
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    • A61B2018/00077—Electrical conductivity high, i.e. electrically conducting
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    • A61B2018/00279—Anchoring means for temporary attachment of a device to tissue deployable
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    • A61B2018/1407—Loop
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    • 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
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
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    • 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
    • A61B2018/1497—Electrodes covering only part of the probe circumference

Definitions

  • the invention relates to the field of medical devices, in particular to a nerve ablation device.
  • the cross-section of the airway 810 is approximately D-shaped, and the esophagus 820 is usually attached to the flat side of the airway 810.
  • multiple electrodes 840 on the nerve ablation device are usually The circumference is distributed on the electrode support structure 830. After the electrode 840 is attached to the site to be ablated, the electrode 840 outputs RF energy centered on itself to destroy the nerve on the tissue to achieve the effect of blocking the nerve.
  • the electrode 840 needs to output enough radio frequency (Radio Frequency) energy to realize the ablation of the area away from the electrode 840, which leads to high radio frequency energy in the central area, which easily causes the esophagus located in the airway 810. 820 were burned.
  • Radio Frequency Radio Frequency
  • a nerve ablation device including a support body and a hanger
  • the hanger is arranged along the circumference of the support
  • the hanger has a mesh structure
  • the hanger includes In the first area and the second area, the hanging part includes a network structure formed by a plurality of mesh wires.
  • the plurality of mesh wires intersect and at least part of the mesh wire intersects are fixedly connected.
  • the mesh wires include braided wires, and the mesh structure is formed by weaving the braided wires.
  • the mesh density of the first region increases less than the mesh density of the second region.
  • the nerve ablation device further includes a buffer structure, the buffer structure is arranged at the intersection of the first area and the second area, and the buffer structure is used to block or weaken the transmission of force between the first area and the second area.
  • the cushioning structure includes a reinforcement, which is connected to the support body and the mesh, and extends from the support body to the intersection of the first area and the second area.
  • the mesh is made of a conductive material such that the mount forms a mesh electrode.
  • the rigidity of the end of the support close to the hanging part is smaller than the rigidity of the end away from the hanging part.
  • the support member has a mesh structure, and the area of the smallest mesh hole at the end of the support member close to the hanger is greater than the area of the smallest mesh hole at the end far away from the hanger.
  • the cross-sectional area of the support gradually decreases from an end close to the hanging part to an end away from the hanging part.
  • At least part of the hanging part is bent toward the center of the supporting body, and the sidewall of the hanging part includes an arc-shaped curved surface.
  • the support body includes a disc-shaped braid formed by weaving at least one braiding wire, and the hanging member is arranged on a circumferential side wall of the disc-shaped braid.
  • the nerve ablation device further includes a cooling balloon, which is penetrated in the support body, and after the cooling balloon is inflated, the side wall of the cooling balloon is attached to the side wall of the support body.
  • a heat conduction hole is opened on the side wall of the support body, and when the cooling balloon is inflated, the cooling balloon covers the heat conduction hole.
  • the beneficial effects of the nerve ablation device of the present invention are:
  • the support body When the support body is released in the airway, the support body pushes the hanger to fit on the inner wall of the airway, wherein the first area is attached to the side wall of the airway close to the esophagus, and the second area is attached to the side wall of the airway away from the esophagus.
  • the first area and the second area are squeezed by the air passage, the area of the mesh on the first area shrinks less, and the area of the mesh on the second area shrinks more, that is, the first The conductive filaments on the area are relatively sparse, and the conductive filaments on the second area are relatively dense.
  • the ablation energy emitted by the first area is smaller than that emitted by the second area, thus weakening the mount burns to the esophagus.
  • Fig. 1 is a schematic cross-sectional structure diagram of an airway in the prior art
  • FIG. 2 is a schematic diagram of an electrode support structure in the prior art
  • Fig. 3 is a schematic structural diagram of the ablation device in Embodiment 1 of the present invention.
  • Fig. 4 is a structural schematic diagram of the mounting part in Embodiment 1 of the present invention.
  • Fig. 5 is a schematic structural diagram of the electrode emitting an ablation energy field in Embodiment 1 of the present invention.
  • FIG. 6 is a schematic structural diagram of a fixed connection point in Embodiment 1 of the present invention.
  • Fig. 7 is another structural schematic diagram of the fixed connection point in Embodiment 1 of the present invention.
  • Fig. 8 is a schematic structural view of the mount in Embodiment 1 of the present invention after being compressed by the airway;
  • Fig. 9 is a schematic diagram of the connection structure of the hanger and the support body in Embodiment 1 of the present invention.
  • Fig. 10 is a structural schematic diagram of a gap between the electrode support body and the inner wall of the airway in the prior art
  • FIG. 11 is a schematic diagram of the connection structure of the buffer structure in Embodiment 1 of the present invention.
  • Fig. 12 is an enlarged schematic diagram of the structure at C in Fig. 11 of the present invention.
  • Fig. 13 is a schematic diagram of the unfolded structure of the hanger in Embodiment 1 of the present invention.
  • Fig. 14 is a schematic diagram of the installation structure of the electrode on the bracket in Embodiment 1 of the present invention.
  • Fig. 15 is a schematic structural diagram of the ablation device in Embodiment 2 of the present invention.
  • Fig. 16 is a schematic structural diagram of the ablation device in Embodiment 3 of the present invention.
  • Fig. 17 is a schematic structural view of the cooling balloon in Embodiment 4 of the present invention.
  • FIG. 18 is a schematic structural view of the cooling duct in Embodiment 4 of the present invention.
  • An embodiment of the present invention provides an ablation device, as shown in Figures 3 to 9, including a support body 110 and a hanger 120, the hanger 120 is arranged along the circumference of the support body 110, and the hanger 120 is in the shape of a mesh structure, the mount 120 includes a first region 121 and a second region 122, and when the mount 120 is squeezed by the air channel 810, the mesh density of the first region 121 increases less than the mesh density of the second region 122 increase in density.
  • the ablation device is used to generate ablation energy at the tissue to be ablated in the human body, and the ablation energy can ablate the nerves in the tissue, thereby achieving the effect of treating the diseased part of the human body.
  • the ablation device can be used for ablation of airway, heart, aorta, stomach and other parts.
  • the ablation device is delivered into the airway 810 through the delivery device, and then the ablation device ablates the nerves on the tissue of the airway 810, thereby dilating the airway 810 to achieve the treatment of lung diseases.
  • the support body 110 includes a loaded state and an expanded state.
  • the support body 110 is located in the delivery device, the support body 110 is in the loaded state. At this time, the support body 110 is compressed in the sheath of the delivery device to facilitate the delivery of the support body 110 .
  • the supporting body 110 is released in the airway 810 , the supporting body 110 expands by itself, and drives the hanging part 120 to attach to the inner wall of the airway 810 .
  • the support body 110 may be in the shape of a tube, a rod, a disk or a block, and the support body 110 may be cut from a memory metal material or woven from a wire-like material.
  • the supporting body 110 has a certain degree of elasticity, and when the mounting part 120 is squeezed by the air channel 810 , the supporting body 110 provides elastic supporting force for the mounting part 120 to ensure the contact area between the mounting part 120 and the inner wall of the air channel 810 .
  • the hanger 120 can be formed by weaving, cutting from a metal material, or a mesh structure made of a conductive material.
  • the hanger 120 is arranged around the support body 110.
  • the hanger 120 can be wound on the support body 110 and connected to the support body 110.
  • Welded or integrally connected the outer wall of the mount 120 has a mesh structure and is attached to the inner wall of the air channel 810 .
  • one axial end of the support body 110 is bent radially outwards and heat-set to form the mount 120 , the mount 120 is used to mount the electrode 840 , and the electrode 840 is installed on the mount 120
  • An ablation energy field is formed to effect ablation of airway 810 tissue.
  • both the hanging part 120 and the supporting body 110 are formed by braiding conductive threads, and the conductive threads on the hanging part 120 are exposed to form a mesh electrode 840; Insulation.
  • the mount 120 After electrifying the conductive wire, the mount 120 forms a mesh electrode 840 to output radio frequency (Radio Frequency) energy to destroy the nerves in the tissue of the airway 810 .
  • radio frequency Radio Frequency
  • the conductive wire can be nickel-titanium alloy wire, stainless steel wire or any other conductive wire.
  • One end of the conductive wire is connected to an RF (Radio Frequency) energy meter, and the RF energy meter provides electrical energy to the conductive wire, and the electrical energy passes through the support body 110 and then is transmitted to the mount 120 to form an ablation energy field 700 .
  • the ablation energy field 700 is centered on the support body 110 , and then radially spreads outward layer by layer from the position where the mount 120 and the airway 810 are attached.
  • the mount 120 can be roughly regarded as a point electrode.
  • a continuous electrode can be formed with the mount 120 as the center and the position where the mount 120 fits the airway 810 as the starting point.
  • the ring-shaped ablation energy field 700 compared with the ablation method in which multiple point electrodes 840 generate multiple overlapping ring-shaped energy fields, the energy of the mesh electrode is more uniform, and it is easier to control the output ablation energy, reducing the ablation The probability that the device will cause burns to the airway 810.
  • the increase of the mesh density of the first region 121 is smaller than the increase of the mesh density of the second region 122 .
  • the mesh density in this embodiment refers to the number of meshes per unit area
  • the increase in mesh density refers to the number of meshes per unit area when the support body 110 is not squeezed.
  • the first area 121 and the second area 122 are arranged along the circumferential direction of the hanger 120, and the ratio of the circumferential lengths of the first area 121 and the second area 122 is: 0.3-1; specifically, the first area 121 and the second The ratio of the circumferential length of the region 122 is 0.3, 0.5, 0.6, 0.8 or 1.
  • a transparent first tooling in the shape of a cuboid is provided, and a first lumen structure corresponding to the outline of the hanger 120 is opened on the first tooling, and a first lumen structure is provided on the outer wall of the first tooling.
  • a plurality of measuring squares with the same area after the hanger 120 is released in the first lumen structure, the side wall of the hanger 120 is attached to the inner wall of the first lumen structure but has no interaction force, and the electronic
  • the microscope magnifies the first tooling by a certain magnification, calculates the number of meshes t1 in a single measuring grid by the mesh method, and provides a second tooling corresponding to the airway section.
  • the second lumen structure is provided, the outer side wall of the second tooling is provided with a plurality of measuring grids with the same area, and the hanger 120 is released in the second lumen structure and attached to the inner wall of the second lumen structure, Use an electron microscope to magnify the second tooling by a certain factor, and use the mesh method to calculate the number of meshes t2 in a single measurement grid, and the increase in mesh area is t2-t1.
  • the hanging part 120 includes a plurality of mesh wires, the mesh structure formed by the mesh wires, the mesh wires are formed by weaving braided wires, and the braided wires can be conductive wires, nickel-titanium alloy wires or stainless steel wires, for example,
  • the conductive threads intersect and are fixedly connected, and at the second area 122 , the conductive threads intersect and are movably connected.
  • the conductive wires intersect to form a grid or mesh, and the two intersected conductive wires are welded or wound at the fixed connection point 126. In this way, as shown in FIGS.
  • the intersecting two conductive filaments have been fixed, so that the displacement of the two adjacent conductive filaments moving toward each other is small or remains unchanged, so that the mesh on the first region 121
  • the area of s1 remains unchanged or the reduction of the mesh area s1 is small, so that the increase of the density of the mesh on the first region 121 is small.
  • the two intersecting conductive threads are attached to each other, and the two intersecting conductive threads can move away from each other or move toward each other.
  • the hanging part 120 includes a mesh wire cut from a metal material.
  • An arc-shaped network structure is formed by weaving conductive threads, the conductive threads on the second region 122 intersect and are flexibly connected, and the two ends of the first region 121 and the second region 122 in the length direction are bonded together.
  • the first region 121 and the second region 122 are squeezed by the air channel 810, the first region 121 is formed by cutting the metal material, so that the mesh area s1 can remain unchanged when the first region 121 is squeezed.
  • the mesh size of the second region 122 is reduced by s2 is larger, so that the increase in the density of the meshes in the first region 121 is smaller than the increase in the density of the meshes in the second region 122 .
  • the advantage of this arrangement is that when the support body 110 is released in the airway 810, the support body 110 pushes the bracket 120 to fit on the inner wall of the airway 810, wherein the first area 121 fits on the airway 810 close to the esophagus 820
  • the side wall of the second region 122 is attached to the side wall of the airway 810 away from the esophagus 820.
  • the area of the mesh on the first region 121 is reduced The amount is small, and the area reduction of the mesh on the second region 122 is relatively large, that is, the conductive filaments on the first region 121 are relatively sparse, and the conductive filaments on the second region 122 are relatively dense.
  • the ablation energy emitted by the first area 121 is smaller than the ablation energy emitted by the second area 122 , thereby weakening the burn of the esophagus 820 by the attachment 120 .
  • the stiffness of the end of the support member close to the hanger 120 is smaller than the stiffness of the end away from the hanger 120 .
  • the support body 110 has a network structure, the support body 110 includes a first end portion 111 and a second end portion 112, the first end portion 111 is connected to the hanging part 120, and the first end portion 111 is connected to the hanging part 120.
  • the area of the smallest mesh on the end 111 is greater than the area of the smallest mesh on the second end 112 .
  • first end portion 111 refers to the end covered by the radial projection of the hanging member 120 on the supporting body 110
  • the second end portion 112 refers to the end of the supporting body 110 away from the hanging member 120
  • the smallest mesh on the first end 111 refers to the area S3 of the smallest mesh formed by the intersection of the conductive wires on the first end 111
  • the smallest mesh on the second end 112 refers to the conductive wire
  • the area S4 of the smallest mesh formed by intersecting on the second end 112 the area of the smallest mesh on the first end 111 is greater than the area of the smallest mesh on the second end 112, that is, the first end 111
  • the area of any mesh hole on the top is greater than the area of the mesh hole on the second end portion 112 .
  • the area of the mesh on the first end portion 111 is relatively large, that is, the density of the braided filaments on the first end portion 111 is relatively low. At this time, the deformability of the first end portion 111 is greater than that of the second end portion 112, When the hanger 120 is squeezed by the air channel 810, the first end 111 can follow the deformation of the second end 112, avoiding the support body 110 from interfering with the deformation of the hanger 120, and making the hanger 120 easier to adapt
  • the D-shaped profile of the air passage 810 increases the wall-adherence of the mount 120, and the area of the mesh on the second end 112 is relatively small, that is, the density of the conductive wire on the second end 112 is low. At this time, The anti-deformation performance on the second end portion 112 is greater than that of the first end portion 111, so that the second end portion 112 can provide support force for the first end portion 111, increasing the stability of delivery and release of the support body 110 .
  • the diameter of the braided wire at the first end 111 is smaller than the diameter of the braided wire at the second end 112, because the rigidity of the braided wire with a larger diameter is greater than the stiffness of the braided wire with a smaller diameter, thereby The stiffness at the first end 111 is greater than the stiffness at the second end 112 , so that the stiffness of the end of the support close to the hanger 120 is smaller than the stiffness of the end away from the hanger 120 .
  • the braided wires at the first end 111 are intersected and connected flexibly, and the braided wires at the second end 112 are intersected and fixedly connected, because the deformation resistance of the fixed connection of the braided wires is greater than that of the intersected and movable braided wires.
  • the anti-deformation performance of the connection makes the stiffness at the first end 111 greater than the stiffness at the second end 112 , so that the stiffness at the end of the support close to the hanger 120 is smaller than the stiffness at the end far away from the hanger 120 .
  • the support body 110 since the support body 110 has a relatively large stress in the loaded state, when the support body 110 is released in the air channel 810, the support body 110 is prone to instantaneous expansion and instability. With higher rigidity, the second end 112 has a stronger supporting force, so that the second end 112 can slow down the deformation rate of the first end 111 when it is released, so that the first end 111 is more stable when it is released. for stability.
  • the cross-sectional area of the support body 110 gradually decreases from the first end 111 to the second end 112 .
  • the cross-sectional area of the support body 110 refers to the cross-sectional area of the support body 110 on a radial plane, and the cross-sectional area of the support body 110 gradually decreases from the first end 111 to the second end 112 small, so that the support body 110 presents a frustoconical structure as a whole.
  • the conductive wires at the second end 112 are relatively dense, it is difficult for the support 110 to enter the sheath of the delivery device, and the cross-sectional area passing through the support 110 gradually decreases from the first end 111 to the second end 112 , so that the cross-sectional area of the support body 110 at the second end 112 is smaller, thereby reducing the difficulty for the second end 112 to enter the sheath.
  • the pressure of the smooth muscle 812 of the airway 810 on the electrode support structure 830 is greater than that of the airway.
  • the C-shaped area of the track 810 exerts pressure on the electrode support structure 830, and the deformation of the electrode support structure 830 on the side close to the smooth muscle 812 is greater than the deformation on the side of the electrode support structure 830 close to the C-shaped area.
  • the electrode support structure 830 is close to the smooth muscle 812-
  • the deformation of the side of the electrode support structure 830 will lead to excessive deformation of the side close to the C-shaped area, so that at the transition area where the C-shaped area connects with the smooth muscle 812, a gap s3 is formed between the electrode support structure 830 and the inner wall of the airway 810, making it difficult to align The airway at the gap s3 is ablated.
  • the ablation device further includes a buffer structure 130. Area 122 is connected at the connection point.
  • the buffer structure 130 includes a reinforcing rod 131, which is welded or inserted on the support body 110, and extends to the hanger 120 along the side wall of the support body 110, and the reinforcing rod 131 131 forms an anti-deformation support at the connecting node of the first region 121 and the second region 122, which weakens or blocks the transmission of force from the first region 121 to the second region 122, thus, when the first region 121 is subjected to the smooth muscle 812 During extrusion, the pulling of the first region 121 to the second region 122 is blocked or weakened by the reinforcing rod 131, so that the second region 122 will not be affected by the deformation of the first region 121 so that the second region 122 can maintain the same
  • the C-shaped profile 811 fits together, which improves the wall-adherence of the mount 120 .
  • the cushioning structure 130 includes reinforcing ribs 132.
  • the reinforcing ribs 132 are located in the mesh and are mounted on the mesh.
  • Component 120 is connected circumferentially by braided wires intersecting at both ends.
  • the mesh in the area where the first area 121 and the second area 122 meet includes a first intersection point 123 and a second intersection point 124 where the braided yarn intersects, and the first intersection point 123 and the second intersection point 124 are along the circumferential direction of the hanger 120
  • the reinforcing rib 132 includes a first reinforcing rib 1321 and a second reinforcing rib 1322, the two ends of the first reinforcing rib 1321 are connected with two braided wires on the first intersection point 123, and the two ends of the second reinforcing rib 1322 are connected with the second
  • the two braided wires at the intersection point 124 are connected, the first reinforcing rib 1321 and the second reinforcing rib 1322 are both arc-shaped, and the arc-shaped convex surfaces of the first reinforcing rib 1321 and the second reinforcing rib 1322 are arranged opposite to each other.
  • the reinforcing rib 132 can form an anti-deformation support at the position where the first region 121 and the second region 122 meet, blocking or weakening the force from the first region 121 to the second region 122.
  • the second region 122 will not be affected by the deformation of the first region 121 , so that the second region 122 remains in close contact with the C-shaped contour 811 , which improves the wall-adherence of the mount 120 .
  • the hanger 120 also includes a third area 125, the third area 125 is located between the first area 121 and the second area 122, and the third area 125 forms a free section to slow down the first area 121. Transmission of force to the second region 122 . It can be understood that the structure in which the third region 125 is formed as a free segment is an implementation manner of the buffer structure 130 .
  • the free section refers to an unconstrained section, that is, at the third region 125 , the force transmission effect is low.
  • the braiding filaments at the third region 125 are intersected and movably connected, and the mesh area formed by the intersecting braiding filaments is much larger than the mesh area of any mesh in the first region 121 and/or the second region 122, so that in the third At the region 125, the density of the braided filaments is relatively low, which weakens the transmission effect of the force from the first region 121 to the second region 122, so that the second region 122 will not be affected by the deformation of the first region 121, so that the second region 122 remains in close contact with the C-shaped profile 811 , which improves the wall-adhesion of the mount 120 .
  • the ratio of the circumferential lengths of the second region 122 to that of the first region 121 is 1.1-4.
  • the ratio of the circumferential lengths of the second region 122 and the first region 121 may be 1.1, 1.5, 2, 3 or 4.
  • the transition region between the first region 121 and the second region 122 is comparable to the transition region between the C-shaped contour 811 of the airway 810 and the smooth muscle 812.
  • the adaptability to the airway 810 is further improved.
  • the mounting part 120 has an arc-shaped structure, and the convex surface of the arc-shaped structure is set toward the side away from the support body 110 .
  • the hanging member 120 is bent from one axial end of the support body 110 toward the outside of the support body 110 and then bent toward the inside of the support body 110 , and finally formed by heat setting.
  • the mounting part 120 may not be in contact with the target area. Fitting, during the movement of the mount 120 , the frictional force between the end of the mount 120 and the airway 810 is relatively large, which may easily rub against the airway 810 or cause discomfort to the patient.
  • the arc-shaped structure of the mounting part 120 can fit the inner wall of the air passage 810, thereby increasing the contact area between the arc-shaped structure and the inner wall of the air passage 810, and reducing the contact area between the hanging part 120 and the air passage 810.
  • the friction force of the inner wall is set towards the side away from the support body 110 through the convex surface of the arc structure, so that the end of the hanging part 120 faces the inner side of the supporting body 110, and the hanging part 120 can be avoided during the movement of the hanging part 120.
  • the end of member 120 rubs against airway 810 causing discomfort to the patient.
  • the ablation device includes an electrode 840 disposed on the mount 120 .
  • the electrode 840 can be a strip-shaped electrode 840 or a point electrode 840.
  • the electrode 840 is arranged on the mount 120 along the circumference of the support 110.
  • the electrode 840 can be welded or wound on the mount 120.
  • the electrode 840 and the RF energy meter connected, the RF energy meter energizes the electrodes 840 to cause the electrodes 840 to emit the ablation energy field 700 .
  • the advantage of this arrangement is that when the hanger 120 is squeezed by the air duct 810, the braided wires on the first area 121 intersect and are fixedly connected, and the braided wires on the second area 122 intersect and are flexibly connected, so that the first The amount of mesh reduction on the area 121 is smaller than the amount of mesh reduction on the second area 122, that is, the amount of movement of the different electrodes 840 on the first area 121 moving toward each other is small or unchanged, and the different electrodes 840 on the second area 122 840 move toward each other with a relatively large amount of movement, which makes the overlapping degree of the energy field of the electrode 840 on the first region 121 lower than that of the energy field of the electrode 840 on the second region 122, that is, the ablation energy emitted by the first region 121
  • the ablation energy emitted by the second area 122 is smaller than that of the second region 122, so that the burn of the esophagus 820 by the mount 120 is weakened.
  • the mount 220 includes a plurality of ablation units 221 arranged along the circumferential direction of the support body 210 , two adjacent ablation units 221 are arranged at intervals in the circumferential direction, and the ablation units 221 It is disposed on the support body 210 and located on the first region 222 and/or the second region 223 respectively.
  • the hanger 220 forms a plurality of ablation units 221 during the weaving process.
  • the ablation units 221 have a mesh structure and their edge contours are arc-shaped. Parts are spaced apart to allow room for deformation of the ablation unit 221 .
  • the ablation unit 221 can be set on the first area 222 or the second area 223 at the same time, or only on the first area 222 .
  • the ablation unit 221 includes a first ablation unit 224 and a second ablation unit 225, the first ablation unit 224 is located on the first area 222, the second ablation unit 225 is located on the second area 223, and the second ablation unit 225 is located on the second area 223.
  • the conductive wires on one ablation unit 224 intersect and are fixedly connected, the conductive wires on the second ablation unit 225 intersect and are flexibly connected, and there is a certain distance between two circumferentially adjacent ablation units 221 .
  • the mounting member 220 when the mounting member 220 is pressed by the airway, there is a distance between two adjacent ablation units 221 to block or weaken the force transmission between the two adjacent ablation units 221, when the ablation unit When the ablation unit 221 is squeezed by the smooth muscle 812, on the one hand, the ablation unit 221 will not be interfered by the adjacent ablation unit 221 and extend to both ends, so that the ablation unit 221 is more easily attached to the smooth muscle 812; on the other hand, the ablation unit 221 The unit 221 does not drive the adjacent ablation unit 221 to deform, thereby preventing the ablation unit 221 on the side away from the smooth muscle 812 from being stretched and excessively deformed, making it difficult to fit the C-shaped contour 811, thereby improving the air resistance of the mount 220 Adaptability to the D-shaped profile.
  • the support body 210 includes a plurality of support members 211 arranged at intervals along the circumference of the hanger 220 , and each ablation unit 221 is connected to at least two support members 211 .
  • the support body 210 is formed by laser cutting of a metal material, and the support members 211 are arranged at equal or non-equal intervals along the circumference of the hanging member 220.
  • the number of the support members 211 is not limited in this embodiment.
  • the support member 211 includes a first support arm 2111 and a second support arm 2112, one end of the first support arm 2111 and one end of the second support arm 2112 are connected to form a V-shaped structure, and the first support arm 2111 , the other end of the second support arm 2112 is connected to the ablation unit 221 , and the opening of the V-shaped structure is set towards the side close to the ablation unit 221 . Both ends of each V-shaped structure are respectively connected to two adjacent ablation units 221, and multiple V-shaped structures are arranged along the circumferential direction of the bracket 220.
  • a V-shaped structure is formed by connecting the first support arm 2111 and the second support arm 2112.
  • the long space enables the ablation unit 221 that fits the smooth muscle 812 to deform under pressure to fit the smooth muscle 812;
  • the support 211 is a rod-shaped structure, each support 211 is only connected to one ablation unit 221, each ablation unit 221 is connected to at least two adjacent supports 211, and the adjacent two supports
  • the pieces 211 are arranged at intervals, so that a gap can also be formed between two adjacent support pieces 211, so that the force transmission of two adjacent ablation units 221 can be blocked, and the D of the hanging piece 220 to the airway can be increased.
  • Shape adaptability is arranged at intervals, so that a gap can also be formed between two adjacent support pieces 211, so that the force transmission of two adjacent ablation units 221 can be blocked, and the D of the hanging piece 220 to the airway can be increased.
  • the distance between two adjacent ablation units 221 is 0.2-1 mm; specifically, the distance between two adjacent ablation units 221 may be: .
  • the ends of the two adjacent ablation units 221 can fit together so as to A continuous ablation zone is formed upward.
  • the support body 310 includes a plurality of braided wires, and the braided wires are braided to form a disc-shaped braided body 330 , and the peripheral edge 320 of the disc-shaped braided body 330 forms a hanger.
  • the carrier, the first region and the second region are located on the circumferential edge 320 of the disc-shaped braid 330 .
  • the braided wires of the disc-shaped braid 330 are conductive wires, and the peripheral edge 320 of the disc-shaped braid 330 is exposed, and after electrification, the exposed part forms a mesh electrode.
  • the outer wall of the disc-shaped braid 330 is covered with an insulating layer or the braided wire of the disc-shaped braid 330 is a non-conductive material, and the electrodes are arranged on the outer wall of the disc-shaped braid 330 to form a mount.
  • the braided filaments intersect and are fixedly connected, and at the second region, the braided filaments intersect and are flexibly connected.
  • the first area and the second area are arranged along the circumferential direction of the disc-shaped braid 330 , and the length ratio of the first area and the second area is similar to that of Embodiment 1, and will not be repeated here.
  • the disc-shaped braid 330 is formed by weaving the braided wire through the support body 310.
  • the disc-shaped braid 330 has a better radial support force.
  • the support body 310 provides sufficient The supporting force makes the hanger stick to the inner wall of the airway.
  • the ablation device includes an adjustment member 340, one end of the adjustment member 340 is connected to the axial end of the disc-shaped braid 330, and the other end of the adjustment member 340 passes through the sleeve 350, and the adjustment member 340 is used to adjust the disc-shaped braid. 330 diameter.
  • both axial ends of the disc-shaped braid 330 extend axially outward of the disc-shaped braid 330 to allow a deformation space for diameter adjustment of the disc-shaped braid 330 .
  • One end of the adjustment member 340 is threaded or welded to the axial end of the disc-shaped braid 330 , and the other end of the adjustment member 340 passes through the sleeve 350 .
  • the adjusting member 340 when the diameter of the disc-shaped braid 330 needs to be increased, the adjusting member 340 is pulled, so that the axial ends of the disc-shaped braid 330 move toward each other, thereby increasing the diameter of the disc-shaped braid 330; When the diameter of the disc-shaped braid 330 needs to be reduced, the adjustment member 340 is pushed to move the two axial ends of the disc-shaped braid 330 in opposite directions, thereby reducing the diameter of the disc-shaped braid 330 .
  • the advantage of this setting is that when the supporting body 310 deviates from the target position after being released in the trachea, the diameter of the disc-shaped braid 330 is adjusted by the adjustment member 340, so that the diameter of the disc-shaped braid 330 is reduced to facilitate the adjustment of the disc-shaped braid 330
  • the position in the airway reduces the difficulty of adjusting the position of the support body 310 in the airway.
  • the ablation device includes a cooling balloon 430 , and the cooling balloon 430 is penetrated in the support body 410 .
  • the cooling balloon 430 expands, the cooling balloon 430 at least Partially cover the mesh on the hanger 420 .
  • the cooling balloon 430 is used to accommodate the cooling medium, one end of the delivery channel 440 is located in the balloon, and the other end of the delivery channel 440 passes through the sleeve 450, and the cooling medium can be input into the balloon through the catheter.
  • the cooling medium may be a gas cooling medium or a liquid cooling medium, specifically, the cooling medium may be at least one of CO2 flow, physiological saline or purified water.
  • the side walls of the support body 410 and the mount 420 have a mesh structure, and the mesh holes on the mesh structure form heat conduction holes.
  • a cooling medium is input into the cooling balloon 430 to expand the balloon.
  • the cooling balloon 430 is inflated, it is attached to the side walls of the support body 410 and the hanger 420, and covers the mesh holes of the support body 410 and the hanger 420 so that the side wall of the cooling balloon 430 is attached to the inner wall of the airway , the heat on the inner wall of the airway can be transferred to the cooling balloon 430 through the heat conduction holes, which increases the heat conduction efficiency and improves the cooling effect of the balloon.
  • the cooling medium in the balloon is drawn out to make the balloon deflate, and then the balloon and the support body 410 are drawn out.
  • the side wall of the cooling balloon 430 can cover the mesh holes of the supporting body 410 and the mounting part 420 by passing the cooling balloon 430 in the support body 410, so that the cooling balloon
  • the side wall of the 430 can be attached to the inner wall of the airway, which realizes the cooling of the electrode and the inner wall of the airway, and avoids burning the inner wall of the airway due to excessive ablation temperature.
  • the ablation device includes a cooling duct 460 , the cooling duct 460 is arranged around the support body 410 and is located inside the mount 420 , and the outer wall of the cooling duct 460 is attached to the inner wall of the mount 420 .
  • the cooling conduit 460 is provided with injection holes, the position of the injection holes corresponds to the position of the holes on the mounting part 420, the cooling medium passes through the injection holes, and passes through the mesh holes on the mounting part 420 to spray to the air passage.
  • Inner wall so as to realize the cooling of the inner wall of the airway, and avoid burning the inner wall of the airway when the ablation temperature is too high.

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Abstract

一种神经消融装置，包括支撑体(110、210、310、410)和挂载件(120、220、420)，挂载件(120、220、420)沿支撑体(110、210、310、410)的周向设置，挂载件(120、220、420)呈网状结构，挂载件(120、220、420)包括沿支撑体(110、210、310、410)周向设置的第一区域(121、222)和第二区域(122、223)，挂载件(120、220、420)包括多根网丝形成的网状结构，在第一区域(121、222)，多根网丝相交且至少部分网丝相交处固定连接。由此，当支撑体(110、210、310、410)在气道(810)内释放时，支撑体(110、210、310、410)推动挂载件(120、220、420)贴合于气道(810)的内壁，当第一区域(121、222)和第二区域(122、223)受到气道(810)的挤压时，第一区域(121、222)上的网孔面积缩小量较小，当第一区域(121、222)和第二区域(122、223)通电时，第一区域(121、222)发出的消融能量小于第二区域(122、223)发出的消融能量，从而减弱了挂载件(120、220、420)对食道(820)的灼伤。

Description

神经消融装置 技术领域
本发明涉及医疗器械领域，特别是涉及一种神经消融装置。
背景技术
本部分提供的仅仅是与本公开相关的背景信息，其并不必然是现有技术。
如图1、图2所示，气道810横截面的轮廓近似D型，食道820通常贴合于气道810较为平坦的一侧，现有技术中，神经消融装置上的多个电极840通常圆周分布于电极支撑结构830上，待电极840与待消融的部位贴合后，电极840以自身为中心输出RF能量来破坏组织上的神经以达到阻断神经的效果，然而，为了消融远离电极840的区域，电极840需要输出足够的射频(Radio Frequency)能量来实现远离电极840的区域的消融，这就导致在中心区域，射频能量较高，从而容易引起位于与气道810贴合的食道820被灼伤。
发明内容
基于此，有必要提供一种神经消融装置，包括支撑体和挂载件，挂载件沿支撑体的周向设置，挂载件呈网状结构，挂载件包括沿支撑体周向设置的第一区域和第二区域，挂载件包括多根网丝形成的网状结构，在第一区域，多根网丝相交且至少部分网丝相交处固定连接。
可选地，网丝包括编织丝，网状结构由编织丝编织形成。
可选地，当挂载件受到朝向支撑体内侧的压力时，第一区域的网孔密度的增加量小于第二区域的网孔密度的增加量。
可选地，神经消融装置还包括缓冲结构，缓冲结构设置于第一区域和第二区域的交点处，缓冲结构用于阻断或减弱第一区域和第二区域之间力的传递。
可选地，缓冲结构包括加强件，加强件与支撑体和网丝连接，且自支撑体延伸至第一区域和第二区域的交点处。
可选地，网丝由导电材料制成以使挂载件形成网状电极。
可选地，支撑体靠近挂载件一端的刚度小于远离挂载件一端的刚度。
可选地，支撑件呈网状结构，支撑件靠近挂载件的端部的最小的网孔的面积大于远离挂载件的端部的最小的网孔的面积。
可选地，支撑体的横截面积由靠近挂载件的一端向远离挂载的件一端逐渐减小。
可选地，至少部分挂载件向靠近支撑体中心的方向折弯，挂载件的侧壁包括弧形曲面。
可选地，支撑体包括由至少一根编织丝编织形成的盘状编织体，挂载件设于盘状编织体的周向侧壁。
可选地，神经消融装置还包括冷却球囊，冷却球囊穿设于支撑体内，在冷却球囊膨胀后，冷却球囊的侧壁与支撑体的侧壁贴合。
可选地，支撑体的侧壁上开设有导热孔，当冷却球囊膨胀后，冷却球囊覆盖导热孔。
与现有技术相比，本发明的神经消融装置的有益效果是：
当支撑体在气道内释放时，支撑体推动挂载件贴合于气道的内壁，其中，第一区域贴合于气道靠近食道的侧壁，第二区域贴合于气道远离食道的侧壁，当第一区域和第二区域受到气道的挤压时，第一区域上的网孔面积缩小量较小，第二区域上的网孔的面积缩小量较大，即，第一区域上的导电丝较为稀疏，第二区域上的导电丝较为密集，当第一区域和第二区域通电时，第一区域发出的消融能量小于第二区域发出的消融能量，从而减弱了挂载件对食道的灼伤。
附图说明
图1为现有技术中气道的截面结构示意图；
图2为现有技术中电极支撑结构的示意图；
图3为本发明的实施例一中的消融装置的结构示意图；
图4为本发明的实施例一中的挂载件的结构结构示意图；
图5为本发明的实施例一中的电极发出消融能量场的结构示意图；
图6为本发明的实施例一中的固定连接点的结构示意图；
图7为本发明的实施例一中的固定连接点的另一结构示意图；
图8为本发明的实施例一中的挂载件受到气道压迫后的结构示意图；
图9为本发明的实施例一中的挂载件和支撑体的连接结构示意图；
图10为现有技术中电极支撑体与气道内壁之间具有间隙的结构示意图；
图11为本发明的实施例一中的缓冲结构的连接结构示意图；
图12为本发明的图11中的C处结构放大示意图；
图13为本发明的实施例一中的挂载件的展开结构示意图；
图14为本发明的实施一中的电极在挂载件上的安装结构示意图；
图15为本发明的实施例二中的消融装置的结构示意图；
图16为本发明的实施例三中的消融装置的结构示意图；
图17为本发明的实施例四中的冷却球囊的结构示意图；
图18为本发明的实施例四中的冷却导管的结构示意图。
具体实施方式
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本发明内涵的情况下做类似改进，因此本发明不受下面公开的具体实施的限制。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。
实施例一
本发明的实施例提供一种消融装置，如图3至图9所示，包括支撑体110和挂载件120，挂载件120沿支撑体110的周向设置，挂载件120呈网状结构，挂载件120包括第一区域121和第二区域122，当挂载件120受到气道810的挤压时，第一区域121的网孔密度的增加量小于第二区域122的网孔密度的增加量。
消融装置用于在人体待消融组织处产生消融能量，消融能量可以消融组织 内的神经，从而达到治疗人体病变部位的效果。消融装置可以用于气道、心脏、主动脉、胃等部位的消融。例如，在本实施例中，通过传递装置将消融装置输送至气道810内，然后消融装置将气道810组织上的神经消融，从而扩张气道810，实现肺部疾病的治疗。
支撑体110包括装载状态和膨胀状态，当支撑体110位于输送装置内时，支撑体110处于装载状态，这时，支撑体110被压缩于输送装置的鞘管内以便于支撑体110的输送。当支撑体110在气道810内释放时，支撑体110自膨胀，带动挂载件120贴合于气道810的内壁。
支撑体110可以呈管状、杆状、圆盘状或方块状，支撑体110可以由记忆金属材料切割形成或由丝状材料编织形成。支撑体110具有一定的弹性，在挂载件120受到气道810的挤压时，支撑体110为挂载件120提供弹性支撑力，保证挂载件120与气道810内壁的接触面积。
挂载件120可以编织形成、经金属材料切割形成或由导电材料制成的网状结构，挂载件120环绕支撑体110设置，挂载件120可以缠绕于支撑体110上、与支撑体110焊接或一体连接，挂载件120的外侧壁呈网状结构且贴合于气道810的内壁。在其它的实施例中，支撑体110的轴向一端径向向外折弯并经过热定型形成挂载件120，挂载件120用于安装电极840，电极840在挂载件120上安装后形成消融能量场以实现对气道810组织的消融。
在本实施例中，挂载件120、支撑体110均由导电丝编织形成，挂载件120上的导电丝裸露形成网状电极840；支撑体110上的导电丝的外侧壁上包覆有绝缘层。对导电丝通电后，挂载件120形成网状电极840以输出射频(Radio Frequency)能量来破坏气道810组织内的神经。
导电丝可以为镍钛合金丝、不锈钢丝或其它任意可以导电的丝状物。导电丝的一端与RF(Radio Frequency)能量仪连接，RF能量仪向导电丝提供电能，电能经过支撑体110后到传输至挂载件120形成消融能量场700。如图5所示，该消融能量场700以支撑体110为中心，然后自挂载件120与气道810贴合的部位径向逐层向外扩散。
如图5所示，可以将挂载件120大致视为一个点电极，这样，可以以挂载 件120为中心，以挂载件120与气道810贴合的位置为起点，形成一个连续的环形消融能量场700，与多个点电极840产生多个交叠的环形能量场的消融方式相比，网状电极的能量更为均匀，且更容易对输出的消融能量进行控制，减小消融装置对气道810产生灼伤的概率。
进一步地，为了减小消融过程中对食道820的损伤，如图4所示，挂载件120包括沿支撑体110周向设置的第一区域121和第二区域122，当挂载件120受到气道810的挤压时，第一区域121的网孔密度的增加量小于第二区域122的网孔密度的增加量。
需要说明的是，本实施例中的网孔密度指的是单位面积内的网孔数量，网孔密度的增加量指的是，在支撑体110未受挤压时的单位面积内的网孔数量减去支撑体110受到挤压后的单位面积的网孔数量。第一区域121和第二区域122沿挂载件120的周向设置，第一区域121和第二区域122的周向长度的比例为：0.3～1；具体地，第一区域121和第二区域122的周向长度的比例为0.3、0.5、0.6、0.8或1。
值得解释的是，可以通过电子显微镜拍照测量法来实现网孔密度的测量。例如，在一种实施方式中，提供一个呈长方体形状的透明的第一工装，第一工装上开设有与挂载件120的轮廓对应的第一管腔结构，第一工装的外侧壁上设置多个具有相同面积的测量方格，挂载件120在第一管腔结构内释放后，挂载件120的侧壁与第一管腔结构的内壁贴合但不具有相互作用力，使用电子显微镜对第一工装放大一定的倍数，用目数法计算单个测量方格内的网孔数量t1，提供一个与气道截面相对应的第二工装，第二工装上开设有与气道轮廓对应设置的第二管腔结构，第二工装的外侧壁设置有多个具有相同面积的测量方格，挂载件120在第二管腔结构内释放且与第二管腔结构的内壁贴合，使用电子显微镜对第二工装放大一定的倍数，用目数法计算单个测量方格内的网孔数量t2，网孔面积的增加量为t2-t1。
在本实施例中，挂载件120包括多根网丝，网丝形成的网状结构，网丝由编织丝编织形成，该编织丝可以为导电丝、镍钛合金丝或不锈钢丝，例如，在第一区域121处，如图6、图7所示，导电丝相交且固定连接，在第二区域122 处，导电丝相交且活动连接。例如，在第一区域121处，导电丝相交形成网格或网孔，相交的两根导电丝在固定连接点126处焊接或缠绕固定，这样，如图8、图9所示，在第一区域121处，当导电丝受压时，相交的两根导电丝已经固定，从而使相邻两根导电丝相向运动的位移量较小或维持不变，进而使第一区域121上的网孔s1面积不变或网孔面积s1的缩小量较小，从而使第一区域121上的网孔的密度的增加量较小。在第二区域122处，相交的两根导电丝相互贴合，相交的两根导电丝可以相背运动或相向运动，这样，在第二区域122处，当导电丝受压时，相交的两根导电丝产生相向运动的位移量较大，进而使第二区域122上的网孔面积s2的缩小量较大，即第二区域122上的网孔密度的增加量较大。
在另一实施例中，挂载件120包括由金属材料切割形成的网丝，例如，在一种实施方式中，第一区域121由金属材料经切割形成弧形的网丝，第二区域122由导电丝编织形成弧形的网状结构，第二区域122上导电丝相交且活动连接，第一区域121和第二区域122的长度方向的两端贴合。由此，当第一区域121和第二区域122受到气道810的挤压时，通过第一区域121由金属材料切割形成，使第一区域121受挤压时网孔面积s1可以维持不变，通过第二区域122由导电丝编织形成且第二区域122上的导电丝相交且活动连接，使第二区域122受到气道810的挤压时，第二区域122上的网孔缩小量s2较大，从而实现了第一区域121的网孔的密度的增加量小于第二区域122上的网孔的密度的增加量。
这样设置的好处在于，当支撑体110在气道810内释放时，支撑体110推动挂载件120贴合于气道810的内壁，其中，第一区域121贴合于气道810靠近食道820的侧壁，第二区域122贴合于气道810远离食道820的侧壁，当第一区域121和第二区域122受到气道810的挤压时，第一区域121上的网孔面积缩小量较小，第二区域122上的网孔的面积缩小量较大，即，第一区域121上的导电丝较为稀疏，第二区域122上的导电丝较为密集，当第一区域121和第二区域122通电时，第一区域121发出的消融能量小于第二区域122发出的消融能量，从而减弱了挂载件120对食道820的灼伤。
进一步地，为了减弱支撑体110对第一区域121的变形的干涉，支撑件靠近挂载件120一端的刚度小于远离挂载件120一端的刚度。
在本实施例中，如图9所示，支撑体110呈网状结构，支撑体110包括第一端部111和第二端部112，第一端部111与挂载件120连接，第一端部111上最小的网孔的面积大于第二端部112上的最小网孔的面积。
需要说明的是，第一端部111指的是挂载件120在支撑体110上的径向投影所覆盖的一端，第二端部112是指支撑体110远离挂载件120的一端。第一端部111上的最小的网孔指的是，导电丝在第一端部111上相交形成的最小的网孔的面积S3，第二端部112上的最小网孔指的是导电丝在第二端部112上相交形成的最小的网孔的面积S4，第一端部111上最小的网孔的面积大于第二端部112上的最小网孔的面积，即第一端部111上任意一个网孔的面积大于第二端部112上的网孔的面积。
第一端部111上的网孔的面积较大，即第一端部111上的编织丝的密度较低，这时，第一端部111的变形性能大于第二端部112的变形性能，当挂载件120受到气道810的挤压时，第一端部111可以跟随第二端部112变形，避免支撑体110对挂载件120的变形形成干涉，使挂载件120更易于适应气道810的D型轮廓，增加挂载件120的贴壁性，第二端部112上的网孔的面积较小，即第二端部112上的导电丝的密度较低，这时，第二端部112上的抗变形性能大于第一端部111的抗变形性能，这样，第二端部112可以为第一端部111提供支撑力，增加支撑体110的输送和释放的稳定性。
在另一实施例中，第一端部111处的编织丝的直径小于第二端部112处编织丝的直径，由于直径较大的编织丝的刚度大于直径较小的编织丝的刚度，从而使第一端部111处的刚度大于第二端部112处的刚度，实现了支撑件靠近挂载件120一端的刚度小于远离挂载件120一端的刚度的设置。
在其它的实施例中，第一端部111处的编织丝相交且活动连接，第二端部112处的编织丝相交且固定连接，由于编织丝固定连接的抗变形性能大于编织丝相交且活动连接的抗变形性能，使第一端部111处的刚度大于第二端部112处的刚度，从而实现了支撑件靠近挂载件120一端的刚度小于远离挂载件120一端的刚度的设置。
值得解释的是，由于支撑体110在装载的状态下的应力较大，当支撑体110 在气道810内释放时，支撑体110容易瞬间膨胀而失稳，这时，通过第二端部112具有较高的刚度，使第二端部112具有较强的支撑力，从而使第二端部112可以减缓第一端部111释放时的变形速率，进而使第一端部111在释放时更为稳定。
进一步地，为了减小消融装置装载入递送装置的难度，如图9所示，支撑体110的横截面积由第一端部111向第二端部112逐渐减小。在本实施例中，支撑体110的横截面积指的是支撑体110在径向平面上的横截面积，支撑体110的横截面积由第一端部111向第二端部112逐渐减小，使支撑体110整体上呈现为圆台状结构。
由于第二端部112的导电丝较为密集，导致支撑体110进入输送装置的鞘管的难度较大，通过支撑体110的横截面积由第一端部111向第二端部112逐渐减小，使支撑体110在第二端部112处的横面面积较小，从而减弱了第二端部112进入鞘管的难度。
值得解释的是，如图10所示，对于环状的电极支撑结构830而言，当电极支撑结构830在气道810内释放时，气道810的平滑肌812对电极支撑结构830的压力大于气道810的C型区域对电极支撑结构830的压力，电极支撑结构830靠近平滑肌812一侧的变形大于电极支撑结构830靠近C型区域一侧的变形，这时，电极支撑结构830靠近平滑肌812一侧的变形会带动电极支撑结构830靠近C型区域一侧过度变形，从而在C型区域与平滑肌812连接的过渡区域处，电极支撑结构830与气道810内壁之间形成间隙s3，导致难以对该间隙s3处的气道进行消融。
进一步地，为了便于挂载件120与气道810的D型轮廓贴合，如图11所示，消融装置还包括缓冲结构130，缓冲结构130与挂载件120在第一区域121和第二区域122的连接点处连接。
在一个实施例中，如图11所示，缓冲结构130包括加强杆131，加强杆131焊接或插设于支撑体110上，且沿支撑体110的侧壁延伸至挂载件120，加强杆131在第一区域121和第二区域122的连接节点处形成抗变形支撑，减弱或阻断了第一区域121向第二区域122的力的传递，由此，当第一区域121受到平滑 肌812的挤压时，通过加强杆131阻断或减弱第一区域121对第二区域122的牵拉，使第二区域122不会受到第一区域121变形的影响以使第二区域122可以保持与C型轮廓811贴合，提高了挂载件120的贴壁性。
在另一实施例中，如图12所示，缓冲结构130包括加强筋132，在第一区域121和第二区域122相接的区域，加强筋132位于网孔内且与网孔在挂载件120周向两端相交的编织丝连接。在第一区域121、第二区域122相接的区域内的网孔包括编织丝相交的第一交点123和第二交点124，第一交点123和第二交点124沿挂载件120的周向设置，加强筋132包括第一加强筋1321和第二加强筋1322，第一加强筋1321的两端与第一交点123上的两根编织丝连接，第二加强筋1322的两端与第二交点124上的两根编织丝连接，第一加强筋1321和第二加强筋1322均呈弧形结构，第一加强筋1321和第二加强筋1322的弧形凸面相对设置。这样，通过加强筋132的设置，使加强筋132可以在第一区域121、第二区域122相接的位置形成抗变形支撑，阻断或减弱了第一区域121向第二区域122的力的传递，从而使第二区域122不会受到第一区域121变形的影响，以使第二区域122保持与C型轮廓811贴合，提高了挂载件120的贴壁性。
进一步地，如图13所示，挂载件120还包括第三区域125，第三区域125位于第一区域121和第二区域122之间，第三区域125形成自由段以减缓第一区域121向第二区域122的力的传递。可以理解，将第三区域125形成自由段的结构为缓冲结构130的一种实施方式。
在本实施例中，自由段指的是非约束段，即在第三区域125处，力的传递效应较低。具体地，第三区域125处的编织丝相交且活动连接，编织丝相交形成的网孔面积远大于第一区域121和/或第二区域122任意网孔的网孔面积，这样，在第三区域125处，编织丝的密度较低，减弱了第一区域121向第二区域122的力的传递效应，从而使第二区域122不会受到第一区域121变形的影响，以使第二区域122保持与C型轮廓811贴合，提高了挂载件120的贴壁性。
进一步地，第二区域122和第一区域121的周向长度的比例为1.1-4。具体地，第二区域122和第一区域121的周向长度的比例可以为1.1、1.5、2、3或4。由此，通过设置第二区域122和第一区域121的周向长度的比例，使第一区域 121和第二区域122的过度区域与气道810的C型轮廓811和平滑肌812的过渡区域相对应，进而提高了对气道810的适应性。
进一步地，为了减弱挂载件与气道内壁的摩擦力，如图14所示，挂载件120呈弧形结构，弧型结构的凸面朝向远离支撑体110的一侧设置。
在本实施例中，挂载件120由支撑体110的轴向一端向支撑体110的外侧折弯然后朝向支撑体110的内侧折弯，最后经过热定型形成。由于支撑体110在气道810内释放的过程中，挂载件120很有可能未与目标区域相贴合，这时，需要操作人员带动挂载件120移动以使挂载件120与目标区域贴合，在挂载件120移动的过程中，挂载件120的端部与气道810之间的摩擦力较大，容易摩擦气道810或使患者产生不适。
由此，通过挂载件120呈弧形结构，使弧形结构可以与气道810的内壁贴合，增加弧形结构与气道810内壁的接触面积，减小挂载件120与气道810内壁的摩擦力，通过弧形结构的凸面朝向远离支撑体110的一侧设置，使挂载件120的端部朝向支撑体110的内侧，在挂载件120移动的过程中，可以避免挂载件120的端部与气道810产生摩擦而使患者产生不适。
在其它的实施例中，如图14所示，消融装置包括电极840，电极840设置于挂载件120上。电极840可以为长条状电极840或点电极840，电极840沿支撑体110的周向设置于挂载件120上，电极840可以焊接或缠绕于挂载件120上，电极840与RF能量仪连接，RF能量仪向电极840通电以使电极840发射出消融能量场700。
这样设置的好处在于，当挂载件120受到气道810的挤压时，通过第一区域121上的编织丝相交且固定连接，第二区域122上的编织丝相交且活动连接，使第一区域121上的网孔缩小量小于第二区域122上的网孔缩小量，即第一区域121上的不同的电极840相向运动的运动量较小或不变，第二区域122上的不同的电极840相向运动的运动量较大，进而使第一区域121上的电极840能量场的交叠程度相对第二区域122上的电极840能量场的交叠程度低，即第一区域121发出的消融能量小于第二区域122发出的消融能量，减弱了挂载件120对食道820的灼伤。
实施例二
本实施例与实施例一的区别在于，如图15所示，挂载件220包括多片沿支撑体210周向设置的消融单元221，周向相邻的两片消融单元221间隔设置，消融单元221设置于支撑体210上且分别位于第一区域222和/或第二区域223上。
在本实施例中，挂载件220在编织的过程中形成多片消融单元221，消融单元221呈网状结构且边沿轮廓呈弧形，相邻的两个消融单元221在远离支撑体210的部分具有间隔距离以让出消融单元221的变形空间。消融单元221可以同时设置于第一区域222或第二区域223上，或仅设置于第一区域222上。
例如，在一种实施方式中，消融单元221包括第一消融单元224和第二消融单元225，第一消融单元224位于第一区域222上，第二消融单元225位于第二区域223上，第一消融单元224上的导电丝相交且固定连接，第二消融单元225上的导电丝相交且活动连接，周向相邻的两个消融单元221之间具有一定的间隔距离。
这样，当挂载件220受到气道的挤压时，相邻的两片消融单元221之间具有间隔距离以阻断或减弱相邻两片消融单元221之间的力的传递，当消融单元221受到平滑肌812的挤压时，一方面，消融单元221不会受到相邻的消融单元221的干涉而向两端延伸，从而使消融单元221更容易贴合于平滑肌812，另一方面，消融单元221并不会带动相邻的消融单元221变形，从而避免远离平滑肌812一侧的消融单元221受到牵拉而过度变形导致难以与C型轮廓811贴合，进而提高了挂载件220对气道D型轮廓的适应性。
进一步地，如图15所示，支撑体210包括多个支撑件211，多个支撑件211沿挂载件220的周向间隔设置，每个消融单元221至少与两个支撑件211连接。
在本实施例中，支撑体210由金属材料经激光切割形成，支撑件211沿挂载件220的周向等间隔设置或非等间隔设置，本实施例对支撑件211的数量不进行限定，例如，在一种实施方式中，支撑件211包括第一支撑臂2111和第二支撑臂2112，第一支撑臂2111的一端和第二支撑臂2112的一端连接形成V型结构，第一支撑臂2111、第二支撑臂2112的另一端与消融单元221连接，V型结构的开口朝向靠近消融单元221的一侧设置。每个V型结构的两端分别与相 邻的两个消融单元221连接，多个V型结构沿挂载件220的周向设置。
由此，通过第一支撑臂2111、第二支撑臂2112连接形成V型结构，一方面，第一支撑臂2111和第二支撑臂2112之间具有间隙以让出消融单元221的两端变形伸长的空间，使与平滑肌812贴合的消融单元221可以受压变形以与平滑肌812贴合；另一方面，当第一区域222受到气道的挤压而变形时，通过第一支撑臂2111和第二支撑臂2112之间具有间隙的设置，使相邻的两个消融单元221之间的力的传递被中断，从而增加了挂载件220对气道的D型轮廓的内壁的适应性。
在另一实施例中，支撑件211为杆状结构，每个支撑件211仅与一个消融单元221连接，每个消融单元221至少与相邻两个支撑件211连接，相邻的两个支撑件211间隔设置，这样，相邻的两个支撑件211之间也可以形成间隙，从而可以阻断相邻的两个消融单元221的力的传递，增加了挂载件220对气道的D型轮廓的适应性。
进一步地，相邻的两个消融单元221之间的间隔距离为0.2～1mm；具体地，相邻的两个消融单元221之间的间隔距离可以为：。由此，通过限定相邻的两个消融单元221的间隔距离，当相邻的两个消融单元221在受到压力而变形时，相邻的两个消融单元221的端部可以贴合以在周向上形成连续的消融区。
实施例三
本实施例与实施例一的区别在于，如图16所示，支撑体310包括多根编织丝，多根编织丝编织形成盘状编织体330，盘状编织体330的周向边沿320形成挂载件，第一区域和第二区域位于盘状编织体330的周向边沿320上。
在本实施例中，盘状编织体330的编织丝为导电丝，盘状编织体330的周向边沿320裸露，在通电后，裸露的部分形成网状电极。在其它的实施例中，盘状编织体330的外侧壁覆盖有绝缘层或盘状编织体330的编织丝为非导电材料，电极设置于盘状编织体330的外侧壁形成挂载件。在第一区域处，编织丝相交且固定连接，在第二区域处，编织丝相交且活动连接。其中，第一区域和第二区域沿盘状编织体330的周向设置，第一区域和第二区域的长度比例与实施例一相近，在此不再赘述。
由此，通过支撑体310由编织丝编织形成盘状编织体330，盘状编织体330具有较好的径向支撑力，当挂载件受到气道内壁的挤压时，支撑体310提供足够的支撑力以使挂载件贴合于气道的内壁。
进一步地，消融装置包括调节件340，调节件340的一端与盘状编织体330的轴向一端连接，调节件340的另一端从套管350穿出，调节件340用于调节盘状编织体330的直径。
在本实施例中，盘状编织体330的轴向两端向盘状编织体330的轴向外侧延伸，以让出盘状编织体330的直径调节的变形空间。调节件340的一端与盘状编织体330的轴向一端螺纹连接或焊接，调节件340的另一端从套管350穿出。
在一种实施方式中，当需要增大盘状编织体330的直径时，拉动调节件340，使盘状编织体330的轴向两端相向运动，从而增大了盘状编织体330的直径；当需要减小盘状编织体330的直径时，推动调节件340，使盘状编织体330的轴向两端相背运动，从而减小了盘状编织体330的直径。
这样设置的好处在于，当支撑体310在气管内释放后偏离目标位置时，通过调节件340调节盘状编织体330的直径，使盘状编织体330的直径缩小以便于调节盘状编织体330在气道内的位置，从而减小了支撑体310在气道内位置调节的难度。
实施例四
本实施例与实施例一的区别在于，如图17所示，消融装置包括冷却球囊430，冷却球囊430穿设于支撑体410内，当冷却球囊430膨胀时，冷却球囊430至少部分覆盖挂载件420上的网孔。
在本实施例中，冷却球囊430用于容置冷却介质，输送通道440的一端位于球囊内，输送通道440的另一端从套管450穿出，通过导管往球囊内输入冷却介质可以实现对电极和待消融部位的冷却，冷却介质可以为气体冷却介质或液体冷却介质，具体地，冷却介质可以为CO2气流、生理盐水或纯净水中的至少一种。
支撑体410、挂载件420的侧壁呈网状结构，网状结构上的网孔构成导热孔， 在对气道消融的过程中，往冷却球囊430内输入冷却介质使球囊膨胀，冷却球囊430膨胀后与支撑体410和挂载件420的侧壁贴合，且覆盖支撑体410和挂载件420的网孔以使冷却球囊430的侧壁与气道的内壁贴合，气道内壁上的热量可以经由导热孔传递至冷却球囊430上，增加导热效率，提高了球囊的冷却效果。对气道消融完毕后，将球囊内的冷却介质抽出使球囊收缩，然后将球囊和支撑体410抽出。
由此，当冷却球囊430膨胀后，通过冷却球囊430穿设于支撑体410内，冷却球囊430的侧壁可以覆盖支撑体410和挂载件420的网孔，从而使冷却球囊430的侧壁可以与气道的内壁贴合，实现了对电极和气道内壁的冷却，避免消融温度过高而灼伤气道的内壁。
在其它的实施例中，如图18所示，消融装置包括冷却导管460，冷却导管460环绕支撑体410设置且位于挂载件420的内侧，冷却导管460的外壁与挂载420件的内壁贴合，冷却导管460上开设有喷射孔，喷射孔的位置与挂载件420上网孔的位置相对应，冷却介质通过喷射孔，并穿过挂载件420上的网孔以喷射至气道的内壁，从而实现对气道内壁的冷却，避免消融温度过高灼伤气道内壁。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (13)

  1. 一种神经消融装置，其特征在于，包括支撑体和挂载件，所述挂载件沿所述支撑体的周向设置，所述挂载件呈网状结构，所述挂载件包括沿支撑体周向设置的第一区域和第二区域，所述挂载件包括多根网丝形成的网状结构，在所述第一区域，多根所述网丝相交且至少部分所述网丝相交处固定连接。
  2. 根据权利要求1所述的神经消融装置，其特征在于，所述网丝包括编织丝，所述网状结构由所述编织丝编织形成。
  3. 根据权利要求1所述的神经消融装置，其特征在于，当所述挂载件受到朝向所述支撑体内侧的压力时，所述第一区域的网孔密度的增加量小于所述第二区域的网孔密度的增加量。
  4. 根据权利要求1所述的神经消融装置，其特征在于，所述神经消融装置还包括缓冲结构，所述缓冲结构设置于所述第一区域和所述第二区域的交点处，所述缓冲结构用于阻断或减弱所述第一区域和所述第二区域之间力的传递。
  5. 根据权利要求4所述的神经消融装置，其特征在于，所述缓冲结构包括加强件，所述加强件与所述支撑体和所述网丝连接，且自所述支撑体延伸至所述第一区域和所述第二区域的交点处。
  6. 根据权利要求1所述的神经消融装置，其特征在于，所述网丝由导电材料制成以使所述挂载件形成网状电极。
  7. 根据权利要求1所述的神经消融装置，其特征在于，所述支撑体靠近所述挂载件一端的刚度小于远离所述挂载件一端的刚度。
  8. 根据权利要求7所述的神经消融装置，其特征在于，所述支撑件呈网状结构，所述支撑件靠近所述挂载件的端部的最小的网孔的面积大于远离所述挂载件的端部的最小的网孔的面积。
  9. 根据权利要求1所述的神经消融装置，其特征在于，所述支撑体的横截面积由靠近所述挂载件的一端向远离所述挂载的件一端逐渐减小。
  10. 根据权利要求1所述的神经消融装置，其特征在于，至少部分所述挂载件向靠近所述支撑体中心的方向折弯，所述挂载件的侧壁包括弧形曲面。
  11. 根据权利要求1所述的神经消融装置，其特征在于，所述支撑体包括由至少一根编织丝编织形成的盘状编织体，挂载件设于所述盘状编织体的周向侧壁。
  12. 根据权利要求1所述的神经消融装置，其特征在于，所述神经消融装置还包括冷却球囊，所述冷却球囊穿设于所述支撑体内，在所述冷却球囊膨胀后，所述冷却球囊的侧壁与所述支撑体的侧壁贴合。
  13. 根据权利要求12所述的神经消融装置，其特征在于，所述支撑体的侧壁上开设有导热孔，当所述冷却球囊膨胀后，所述冷却球囊覆盖所述导热孔。
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