WO2023149496A1 - Système médical et son procédé d'utilisation - Google Patents

Système médical et son procédé d'utilisation Download PDF

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Publication number
WO2023149496A1
WO2023149496A1 PCT/JP2023/003336 JP2023003336W WO2023149496A1 WO 2023149496 A1 WO2023149496 A1 WO 2023149496A1 JP 2023003336 W JP2023003336 W JP 2023003336W WO 2023149496 A1 WO2023149496 A1 WO 2023149496A1
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WIPO (PCT)
Prior art keywords
side upright
proximal
upright portion
distal
axial direction
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PCT/JP2023/003336
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English (en)
Japanese (ja)
Inventor
知晃 竹村
侑右 高橋
一成 深見
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テルモ株式会社
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Publication of WO2023149496A1 publication Critical patent/WO2023149496A1/fr

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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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the present invention relates to a medical system equipped with an extension body having electrodes inserted into a living body to cauterize living tissue, and a method of using the same.
  • Chronic heart failure is known as one of the heart diseases. Chronic heart failure is broadly classified into systolic and diastolic failure based on indicators of cardiac function. Patients with diastolic insufficiency have enlarged and stiffened myocardium, which increases pressure in the left atrium and reduces the heart's ability to pump. This causes the patient to present symptoms of heart failure such as pulmonary edema. In addition, there is also a heart disease in which pulmonary hypertension or the like causes the blood pressure in the right atrium to rise and the pumping function of the heart to decline, resulting in symptoms of heart failure.
  • shunt therapy which forms a shunt (through-hole) in the interatrial septum as an escape route for elevated atrial pressure and enables alleviation of heart failure symptoms, has attracted attention for these patients with heart failure.
  • Shunt therapy accesses the atrial septum via a transvenous approach to create a through hole of the desired size.
  • a medical device for performing such a shunt treatment for the interatrial septum there is, for example, one disclosed in Patent Document 1.
  • an expandable body that can be inserted and expanded inside a living body is formed with a concave portion having a partially small expansion diameter, and an electrode is arranged in this concave portion. Then, in a state in which the living tissue is received in the concave portion of the expandable body, the expandable body is axially compressed to grasp the living tissue by the expandable body, and the electrode arranged in the concave portion moves the grasped biological tissue through the through hole. cauterizing around the
  • the power applied to the electrodes is too weak, cauterization cannot be performed, and if the power applied is too high, the tissue surface will be dehydrated or carbonized, and the ablation depth in the thickness direction of the interatrial septum cannot be deepened. Moreover, if the condition of the supplied energy is inappropriate, the ablation depth becomes insufficient, and the formed shunt cannot be maintained, which may lead to a decrease in the therapeutic effect.
  • the present invention has been made to solve the above-described problems, and aims to provide a medical system and a method of using the same that can obtain a desired ablation depth and form a stable shunt.
  • a displacement mechanism that compresses; and
  • a power supply device that includes a control unit that controls power supply to the energy transmission unit, wherein the expansion body extends radially inward in the axial direction.
  • the recess has a distal side upright portion, a proximal side upright portion, and the distal side upright portion and the proximal side so as to define a receiving space capable of receiving a biological tissue.
  • a radially innermost bottom disposed between the uprights, wherein the distal upstands and the proximal uprights are aligned in the axial direction of the expander by the displacement mechanism;
  • the energy transmission part is configured to grasp the living tissue by compression to one of the distal side upright part and the proximal side upright part so as to face the receiving space.
  • the control unit applies a power equivalent to 1.1 to 2.8 W/mm 2 to the energy transmission unit with the expansion body compressed in the axial direction by the displacement mechanism. Configured to apply for 3-45 seconds.
  • a method of using a medical system according to the present invention for achieving the above object includes an expandable body having a central axis and being radially expandable and retractable, and an elongated shaft portion having a distal end portion to which the proximal end of the expandable body is fixed. and an energy transmission part provided along the expandable body, and displacing the base end of the expandable body relative to the distal end of the expandable body substantially along the central axis, thereby displacing the expandable body. and a displacement mechanism that compresses in the axial direction, wherein the expander has a recess that is recessed radially inward in the middle of the axial direction, and the recess receives living tissue.
  • the energy transmission portion is disposed along either one of the distal upright portion and the proximal upright portion so as to face the receiving space;
  • a desired ablation depth is obtained by supplying power corresponding to 1.1 to 2.8 W/mm 2 to the energy transmission unit for 3 to 45 seconds, and stable can form a tight shunt.
  • the control unit supplies power corresponding to 1.1 to 2.8 W/mm 2 to the energy transmission unit for 5 to 25 seconds while the expansion body is compressed in the axial direction by the displacement mechanism. good too. This results in a more desirable ablation depth and a more stable shunt formation.
  • the compression force with which the displacement mechanism compresses the expansion body in the axial direction may be 2 to 9N.
  • FIG. 1 is a side view of a distal portion of a medical device;
  • FIG. 3(A) is a longitudinal cross-sectional view, and (B) is a cross-sectional view taken along line AA in FIG. 3(A).
  • FIG. 4(A) is a vertical cross-sectional view, and (B) is a cross-sectional view taken along line BB of FIG. 4(A).
  • FIG. It is a top view which shows the switch mechanism of a medical device, (A) shows the surface with a terminal, (B) shows the surface with a switch main body.
  • FIG. 4 is a schematic diagram schematically showing a state in which an expander is placed in a through-hole of the interatrial septum;
  • FIG. 4 is a cross-sectional view showing a state in which the balloon is inserted into the interatrial septum;
  • FIG. 4 is a cross-sectional view showing a state in which the distal end of the medical device is inserted into the interatrial septum;
  • FIG. 4 is a cross-sectional view showing a state in which the expander is placed in the interatrial septum;
  • FIG. 4 is a schematic diagram schematically showing a state in which an expander is placed in a through-hole of the interatrial septum;
  • FIG. 4 is a cross-sectional view showing a state in which the balloon is inserted into the interatrial septum;
  • FIG. 4 is a cross-sectional view showing a state in which the distal end of the medical device is inserted into the interatrial septum;
  • FIG. 4 is a cross-
  • FIG. 4 is a cross-sectional view showing a state in which the energy transmission section arranged in the concave portion of the expansion body is in close contact with the living tissue; It is a flow chart for explaining how to use the medical system. It is the schematic which shows an experimental apparatus.
  • Fig. 3 is a graph showing ablation depth versus applied power; 4 is a graph showing ablation depth versus power per unit area of the energy delivery portion; 4 is a graph showing impedance versus power application time;
  • (A) is a longitudinal cross-sectional view which shows the inside of an operation part
  • (B) shows the circuit diagram of a switch mechanism.
  • FIG. 12A is a plan view showing the distal end portion of the medical device in the second modified example, where (A) shows the state before grasping the living tissue by the expander, and (B) shows the state after grasping the living tissue by the expander.
  • distal side the side of a medical device that is inserted into a living body cavity
  • proximal side the side that is operated
  • range "X to Y” includes X and Y and means "X or more and Y or less”.
  • the medical system 1 maintains the size of the through hole Hh formed in the interatrial septum HA, which is the biological tissue of the patient's heart H, and expanded by the balloon. It is configured so that maintenance treatment can be performed.
  • a medical system 1 includes a medical device 10 that is inserted into a living body to cauterize living tissue, and a power supply device 190 that supplies power to the medical device 10. have.
  • the medical device 10 includes an elongated portion 20 extending from a proximal end to a distal end, an extension 21 provided at the distal end of the elongated portion 20, and a plurality of electrodes 24 provided along the extension 21 for energy transmission. It has a portion 22 , an operation portion 23 connected to the base end portion of the elongated portion 20 , and a connection cable 25 connectable to the power supply device 190 .
  • the long portion 20 includes a shaft portion 31 holding the expansion body 21 at the distal end portion, an outer cylinder 30 housing the shaft portion 31, a displacement shaft 33, and a traction portion 35 fixed to the distal end of the displacement shaft 33.
  • the shaft portion 31 is an elongate tubular body extending from the operating portion 23 to the extension body 21 .
  • a proximal end portion of the shaft portion 31 is fixed to a distal end portion of the operation portion 23 .
  • a distal end portion of the shaft portion 31 is fixed to a proximal end portion of the extension body 21 .
  • the outer cylinder 30 is a long tubular body that covers the shaft portion 31, and can move back and forth with respect to the shaft portion 31 in the axial direction (in the direction of the axis of the long portion 20).
  • the outer cylinder 30 can house the expandable body 21 contracted in the radial direction in the state of being moved to the distal end side of the elongated portion 20 .
  • the radial direction is a direction perpendicular to the axis of the shaft portion 31 .
  • the displacement shaft 33 is an elongated tubular body arranged inside the shaft portion 31 and is axially movable forward and backward with respect to the shaft portion 31 .
  • the displacement shaft 33 protrudes distally from the distal end of the shaft portion 31 and protrudes distally from the distal end of the extension body 21 .
  • a distal end portion of the displacement shaft 33 located on the distal side of the extension body 21 is fixed to a pulling portion 35 .
  • a proximal end portion of the displacement shaft 33 is led out from the operation portion 23 to the proximal end side.
  • a guide wire lumen is formed along the axial direction inside the displacement shaft 33, through which the guide wire 11 (see FIGS. 7 to 9) can be passed.
  • the pulling part 35 is an annular member fixed to the outer peripheral surface of the distal end of the displacement shaft 33 and protrudes radially outward from the outer peripheral surface of the displacement shaft 33 .
  • the traction part 35 is not fixed to the extension body 21 .
  • the outer diameter of the pulling part 35 is larger than the inner diameter of the distal end of the expansion body 21 . Therefore, the pulling portion 35 contacts the distal end portion of the expandable body 21 from the distal end side, pulls the expandable body 21 in the proximal direction, and exerts a compressive force compressing the shaft portion 31 along the axial direction. can act on
  • the operation unit 23 includes a housing 100 gripped by the operator, an operation knob 110 that can be moved along the axial direction by the operator, and a movement of the operation knob 110. to the displacement shaft 33, a detection unit 130 for detecting compression of the expansion body 21, an electric wire 160 for transmitting power from the power supply device 190 to the electrode 24, and the shaft portion 31 to the housing 100 It has a shaft connection portion 180 to be connected.
  • the housing 100 has a guide rail 101 that holds the operation knob 110 so that it can slide linearly in the axial direction, and an opening 102 that exposes a part of the operation knob 110 to the outside.
  • the operation knob 110 is arranged slidably along the axial direction of the shaft portion 31 with respect to the housing 100 .
  • the operating knob 110 can move from an initial position (see FIG. 3) in which the expander 21 is not compressed to a compressed position (see FIG. 4) in which the expander 21 is compressed.
  • the operation knob 110 has a knob body 111 exposed to the outside from an opening 102 of the housing 100 so that the operator can operate it, and a guide rail 101 inside the housing 100 so that it can slide linearly in the axial direction. It has a contact sliding portion 112 and a contact portion 113 that can contact the pressing portion 150 .
  • the operation knob 110 further includes an action portion 114 that can contact the tip of the elastic body 120 from the tip side, and a stopper 115 that can contact the base end surface of the ring-shaped fixing member 170 fixed to the displacement shaft 33 .
  • the contact portion 113 is provided only on a part of the operation knob 110 in the axial direction. In this embodiment, the contact portion 113 is formed on the outer peripheral surface of a portion surrounding the displacement shaft 33 in the vicinity of the action portion 114 .
  • the contact portion 113 can contact the pressing portion 150 and press the pressing portion 150 by moving the operation knob 110 to the compression position.
  • the action portion 114 is a portion that applies a traction force in the proximal direction to the displacement shaft 33 via the elastic body 120 .
  • the stopper 115 is arranged closer to the proximal side than the action portion 114 .
  • the stopper 115 abuts on the proximal end surface of the fixing member 170 fixed to the displacement shaft 33 to restrict the displacement shaft 33 from moving in the proximal direction with respect to the operation knob 110 more than necessary.
  • the elastic body 120 is arranged between the operating knob 110 and the displacement shaft 33 to adjust the traction force transmitted from the operating knob 110 to the displacement shaft 33, as shown in FIGS.
  • the elastic body 120 is a coil spring arranged to surround the displacement shaft 33 .
  • the elastic body 120 can be elastically expanded and contracted along the axial direction of the displacement shaft 33 .
  • the distal end of the elastic body 120 can come into contact with the base end surface of the action portion 114 of the operation knob 110 .
  • a proximal end of the elastic body 120 can contact a distal end surface of a fixed member 170 fixed to the displacement shaft 33 .
  • the detection unit 130 includes a detection switch 131 whose state is switched according to the displacement of the displacement shaft 33 by the operation knob 110, and an output for outputting the state change of the detection switch 131 to the power supply device 190. and a portion 132 .
  • the detection switch 131 and output section 132 are electrically independent of the wire 160 .
  • the state of the detection switch 131 is switched according to the displacement of the displacement shaft 33 by the operation knob 110 from the initial position (see FIG. 3) to the compressed position (see FIG. 4).
  • the detection switch 131 has a pressing portion 150 that moves as the operation knob 110 is displaced, and a switch body 133 that can be pressed by the pressing portion 150 .
  • the pressing portion 150 includes a rotating shaft 151 that is rotatably connected to the housing 100, a pressing input portion 152 that can contact the contact portion 113 of the operation knob 110, and a switch body 133 of the detection switch 131. and a pressing output portion 153 .
  • the rotating shaft 151 is rotatable on an axis parallel to the central axis of the displacement shaft 33 .
  • the pressing input portion 152 is arranged in a compressed position where it can come into contact with the contact portion 113 as shown in FIG. be.
  • the pressing input portion 152 moves when pressed by the contact portion 113 and rotates the pressing portion 150 .
  • the pressing output portion 153 can push the switch body 133 . That is, the pressing portion 150 has a pressing state in which the switch body 133 is pressed and a non-pressing state in which the switch body 133 is not pressed in accordance with the operation of the operation knob 110 that moves the displacement shaft 33 from the initial position to the compressed position. can be displaced between
  • the switch body 133 is biased by the force of the spring in a state where no external force acts.
  • the switch main body 133 is pressed by the pressing output portion 153 of the pressing portion 150 to contract the spring.
  • the output unit 132 outputs the state change of the detection switch 131 to the power supply device 190 via the cable 25, as shown in FIGS.
  • the output section 132 has an output circuit 134 electrically independent of a supply circuit 161 for supplying power to the electrodes 24 on a circuit board.
  • the output circuit 134 can come into contact with both the first fixed contact 135 and the second fixed contact 136 which are separately arranged on the circuit board and the first fixed contact 135 and the second fixed contact 136 when pushed down by the switch body 133. and two second terminals 138 electrically connected to the first fixed contact 135 and the second fixed contact 136, respectively.
  • Each of first fixed contact 135 and second fixed contact 136 can be connected to power supply device 190 via connection cable 25 from either of two second terminals 138 .
  • the movable contact 137 is normally separated from the first fixed contact 135 and the second fixed contact 136, but when the switch body 133 is pushed, it moves along with it, and the first fixed contact 135 and the second fixed contact 136 move. contact both. Thereby, the first fixed contact 135 and the second fixed contact 136 are electrically connected via the movable contact 137 .
  • the electric wire 160 has a supply circuit 161 arranged on a circuit board, and an electric wire body portion 162 extending from the supply circuit 161 to the energy transmission portion 22 along the shaft portion 31 .
  • the supply circuit 161 includes two first terminals 163 connectable to a power supply, two energy output terminals 164 connected to the wire body 162, and two connections extending from the first terminals 163 to the energy output terminals 164. and an electric wire portion 165 .
  • the two first terminals 163 are connectable to the power supply device 190 via the connection cable 25 .
  • the two energy output terminals 164 are electrically connected to each of the electrode pairs of the bipolar energy transmission section 22 via the electric wire body section 162 extending from the detection switch 131 to the energy transmission section 22 along the shaft section 31 .
  • the shaft connecting portion 180 has a holding portion 181 fixed and held inside the housing 100 and a seal member 182 arranged inside the holding portion 181.
  • the holding portion 181 is a substantially cylindrical member closely connected to the proximal end of the shaft portion 31 .
  • the seal member 182 is an annular member disposed inside the holding portion 181 on the proximal side of the shaft portion 31 and slidably in contact with the outer peripheral surface of the displacement shaft 33 . Seal member 182 prevents blood or the like from flowing into housing 100 from between shaft portion 31 and displacement shaft 33 .
  • the expansion body 21 includes a force receiving portion 51 arranged at the distal end of the expansion body 21, a proximal connecting portion 52 arranged at the proximal end of the expansion body 21, and the force receiving portion 51. a second connecting portion 53 connected to the base end connecting portion 52; a first connecting portion 54 connected to the base end connecting portion 52; ing.
  • the force receiving portion 51 has an annular shape and can receive a force directed toward the proximal direction from the traction portion 35 arranged on the distal side.
  • the base end connecting portion 52 has an annular shape and is fixed to the distal end portion of the shaft portion 31 .
  • the second connecting portion 53 is flexibly deformable.
  • the second connecting portion 53 includes a distal-side expanding portion 56 extending radially outward from the force-receiving portion 51 toward the proximal direction, and a distal-side expanding portion 56 disposed on the proximal side of the distal-side expanding portion 56 and protruding radially outward. It has a curved distal apex 57 .
  • the second connecting portion 53 has a plurality of distal strut structures 60 extending radially outward from the force receiving portion 51 toward the proximal direction and forming distal extensions 56 .
  • the plurality of distal strut structures 60 are arranged at approximately equal intervals in the circumferential direction of the extension body 21 when inflated.
  • Each of the plurality of distal strut structures 60 includes a first strut 61 extending proximally from the force receiving portion 51 and a distal apex 57 extending proximally from the proximal end of the first strut 61 . and a second strut 62 that is
  • Each first strut 61 extends from the force receiving portion 51 substantially parallel to the axis of the extension body 21 when viewed from the radially outer side.
  • Each of the second struts 62 is bifurcated from the proximal end of each of the first struts 61 toward the proximal direction and spreads in the circumferential direction of the extension body 21, forming a first junction 65 or a second junction 66. merges with The first merging portions 65 and the second merging portions 66 are alternately arranged in the circumferential direction of the expandable body 21 during expansion at approximately equal intervals.
  • Each first merging portion 65 is connected to the tip side apex portion 57 arranged in the same phase as the electrode 24 in the circumferential direction of the expansion body 21 .
  • Each of the second confluences 66 is connected to distal tops 57 arranged at different phases in the circumferential direction of the extension body 21 with respect to the electrode 24 .
  • the first connecting portion 54 is flexibly deformable.
  • the first connecting portion 54 includes a proximal side expanding portion 58 extending radially outward toward the distal direction from the proximal connecting portion 52, and a radially outward convex shape disposed on the distal side of the proximal side expanding portion 58. It has a curved proximal apex 59 .
  • the proximal extension 58 has a plurality of proximal strut structures 90 .
  • Each proximal strut structure 90 is arranged in the same phase with the plurality of electrode arrangement portions 81 in the circumferential direction of the extension body 21 .
  • Each of the plurality of proximal strut structures 90 includes a plurality of third struts 91 extending from the distal end of the shaft portion 31 to the proximal apex 59 substantially parallel to the axis of the expander 21 when viewed from the radially outer side. , and a plurality of secondary struts 92 connecting the third struts 91 adjacent in the circumferential direction.
  • Each secondary strut 92 is connected to each of two circumferentially adjacent third struts 91 .
  • Each secondary strut 92 is curved. Therefore, even if the distance between the two adjacent third struts 91 increases when the expansion body 21 expands, the secondary struts 92 can continue to support the two third struts 91 while deforming into a nearly straight shape. can. Therefore, the expansion body 21 can be expanded by the compressive force applied by the displacement shaft 33 while spreading the third struts 91 at substantially equal intervals.
  • the concave portion 55 is flexibly deformable.
  • the concave portion 55 is recessed radially inward when the expansion body 21 is expanded, and extends so as to connect the proximal side top portion 59 and the distal side top portion 57 .
  • the concave portion 55 defines a receiving space 74 that can receive living tissue when the expansion body 21 is expanded.
  • the recessed portion 55 includes a bottom portion 71 located on the innermost side in the radial direction, a distal side upright portion 72 extending radially outward from the distal end of the bottom portion 71 to a distal side top portion 57 , and a bottom portion 71 extending from the base end of the bottom portion 71 to the proximal side top portion 59 . It has a base end side upright portion 73 extending radially outward.
  • the space between the proximal side upright portion 73 and the distal side upright portion 72 is slightly larger in the axial direction on the outer side than on the inner side in the radial direction when the expansion portion is expanded. This makes it easy to arrange the living tissue from the outside in the radial direction between the proximal side upright portion 73 and the distal side upright portion 72 .
  • the recessed portion 55 has a plurality of recessed strut structures 80 arranged in the circumferential direction.
  • Each of the plurality of recessed strut structures 80 has a plurality of electrode placement portions 81 arranged on the proximal side upright portion 73 and a plurality of facing portions 82 arranged on the distal side upright portion 72 . It has a plurality of bottom connection portions 83 that connect the electrode arrangement portion 81 and the facing portion 82 that form a .
  • the plurality of electrode arrangement portions 81 are arranged at approximately equal intervals in the circumferential direction of the extension body 21 .
  • the plurality of facing portions 82 are arranged at approximately equal intervals in the circumferential direction of the extension body 21 .
  • the plurality of bottom connection portions 83 are arranged at approximately equal intervals in the circumferential direction of the extension body 21 .
  • Each facing portion 82 faces each of the electrodes 24 when the expansion body 21 is expanded.
  • Each facing portion 82 includes a plurality of tip-side upright struts 84 branched into two while spreading toward the tip direction so as to substantially follow the circumferential direction of the expansion body 21 from the tip of each bottom connecting portion 83 , and a plurality of struts 84 . and a backrest portion 85 .
  • a plurality of backrest portions 85 connect two distal standing struts 84 branching from each of the bottom connecting portions 83 .
  • the plurality of backrest portions 85 are arranged side by side from the side closer to the bottom portion 71 toward the side closer to the tip side top portion 57 .
  • Each backrest portion 85 is curved such that the portion between the ends connected to the two distal standing struts 84 protrudes toward the distal top portion 57 .
  • Each of the back support portions 85 is easy to bend on the side closer to the tip-side apex 57 with both ends connected to the tip-side upright struts 84 as fulcrums. Therefore, the back support portion 85 can be bent by the force directed toward the distal side received from the electrode 24 arranged on the proximal side upright portion 73 . Therefore, the living tissue sandwiched between the electrode 24 and the back support portion 85 can be brought into close contact with the electrode 24 .
  • each facing portion 82 the backrest portion 85 closest to the tip-side top portion 57 is connected to the tip-side top portion 57 at a portion protruding toward the tip-side top portion 57. be.
  • the number of backrest portions 85 forming each facing portion 82 is not particularly limited.
  • the energy transmission section 22 has a plurality of electrodes 24 .
  • Each electrode 24 is arranged on the surface forming the inner side of the recess 55 of each electrode arrangement portion 81 .
  • the electrode 24 is arranged in close contact with the surface forming the inner side of the recessed portion 55 of the electrode arrangement portion 81 .
  • At least a portion of the electrode 24 has a convex curved surface facing the receiving space 74 when expanded.
  • the surface of the electrode 24 facing the receiving space 74 during expansion may be planar.
  • the electrode 24 is arranged on the surface of the proximal side upright portion 73 facing the distal side when the extension body 21 is extended. Since the electrode 24 is provided on the proximal side upright portion 73, when the concave portion 55 sandwiches the atrial septum HA, the energy from the electrode 24 is transmitted to the atrial septum HA from the right atrium side. . When the electrode 24 is provided on the distal upright portion 72, the energy from the electrode 24 is transmitted to the interatrial septum HA from the left atrium side.
  • the electrodes 24 are, for example, bipolar electrodes that receive power from the power supply device 190 . In this case, electricity is supplied between the electrodes 24 arranged in each electrode arrangement portion 81 .
  • the electrode 24 may be configured as a monopolar electrode. In this case, electricity is supplied between the electrode and the counter electrode prepared outside the body. Further, the electrode 24 may be a heating element (electrode tip) that generates heat by receiving high-frequency electrical energy from an energy supply device.
  • a heating element electrode tip
  • the electrode 24 is provided on the proximal side upright portion 73 and the back support portion 85 is provided on the distal side upright portion 72 .
  • a backrest portion 85 may be provided in each of the .
  • an operation knob 110 an elastic body 120, a displacement shaft 33, and a pulling section 35 that can move the distal end of the expansion body 21, and a housing 100 and a shaft that can move the proximal end of the expansion body 21
  • the portion 31 functions as a displacement mechanism 26 that axially compresses the expandable body 21 by displacing the proximal end of the expandable body 21 relative to the distal end of the expandable body 21 substantially along the central axis.
  • the expansion body 21 is, for example, cut out from a cylinder and formed integrally.
  • the struts forming extension 21 can be, for example, 50-500 ⁇ m thick and 0.3-2.0 mm wide. However, the struts forming extension 21 may have dimensions outside this range.
  • the shape of the strut is not particularly limited, and may have, for example, a circular cross-sectional shape or other cross-sectional shape.
  • the extension body 21 can be made of a metal material.
  • the metal material for example, titanium-based (Ti--Ni, Ti--Pd, Ti--Nb--Sn, etc.) alloys, copper-based alloys, stainless steels, ⁇ -titanium steels, and Co--Cr alloys can be used. .
  • an alloy having spring properties such as a nickel-titanium alloy.
  • the material of the wire portion is not limited to these, and may be formed of other materials.
  • the outer cylinder 30 and the shaft portion 31 of the elongated portion 20 are preferably made of a material having a certain degree of flexibility.
  • materials include polyolefins such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymers, ethylene-vinyl acetate copolymers, ionomers, or mixtures of two or more of these, soft polyvinyl chloride resins, Polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, fluororesin such as polytetrafluoroethylene, polyimide, PEEK, silicone rubber, latex rubber and the like.
  • the displacement shaft 33 and the pulling part 35 are formed of a long wire such as a superelastic alloy such as a nickel-titanium alloy or a copper-zinc alloy, a metal material such as stainless steel, or a relatively rigid resin material. be able to.
  • a resin material such as polyvinyl chloride, polyethylene, polypropylene, ethylene-propylene copolymer, or fluororesin.
  • the power supply device 190 has a power output section 191, a notification section 192, and a control section 193, as shown in FIG.
  • the power output unit 191 is a part that outputs power for performing maintenance treatment.
  • the power output unit 191 is controlled by the control unit 193 and can output high-frequency current at any power for any time.
  • the notification unit 192 is a part that notifies the operator of the control status, warnings, and the like.
  • the notification unit 192 is, for example, a speaker that notifies with sound or an image monitor that notifies with an image.
  • the display method of the image monitor and the output method of the speaker are not particularly limited.
  • the notification unit 192 may be an external device that is communicably connected to the power supply device 190 without being configured in the power supply device 190 .
  • the control unit 193 is composed of a CPU (Central Processing Unit), a memory circuit, and an operation program.
  • the control unit 193 may be connected to interfaces such as a keyboard and a mouse.
  • the control unit 193 is, for example, a computer.
  • the control unit 193 can control the output of the high-frequency current from the power output unit 191 by controlling the power output unit 191 .
  • the control unit 193 can cause the power output unit 191 to output any power at any time. Therefore, the control unit 193 can supply power of 10 to 25 W, for example.
  • the electrode surface of each electrode 24 capable of supplying electric power in contact with the living tissue has a width (length along the circumferential direction of the extension body 21) of 0.75 mm and a length (extension body 21) is 4 mm. Therefore, the area of the electrode surface of each electrode 24 is 3 mm 2 , and the total area of the electrode surfaces of the six electrodes 24 is 18 mm 2 .
  • the energy transmission section 22 has six electrodes 24 that are bipolar electrodes, so the total area of the transmission surface of the energy transmission section 22 that transmits energy to the living tissue is 9 mm 2 . Therefore, when power of 10 to 25 W is supplied to the energy transmission portion 22, the power per unit area of the transmission surface of the energy transmission portion 22 is 1.1 to 2.8 W/mm 2 .
  • the application time during which the control unit 193 causes the power output unit 191 to output power is not particularly limited, but is preferably 3 to 45 seconds, more preferably 5 to 25 seconds.
  • control unit 193 acquires the value of the high-frequency voltage to be output, acquires the value of the high-frequency current detected by the current sensor arranged in the power supply device 190, and converts the value of the high-frequency voltage into the value of the high-frequency current. By dividing, it is possible to calculate the value of the bioelectrical impedance of the site undergoing cauterization.
  • control unit 193 can transmit information selected from various types of information such as output power, voltage, current, calculated impedance value, threshold value, elapsed time, etc. to the notification unit 192 and display the information. can.
  • the method is performed on a patient suffering from heart failure (left heart failure). More specifically, as shown in FIG. 4, for a patient suffering from chronic heart failure in which the myocardium in the left ventricle of the heart H is hypertrophied and the stiffness (hardness) is increased, the blood pressure in the left atrium HLa is increased. It is the method of treatment that is performed.
  • the method of using the medical device 10 includes the step of forming a through hole Hh in the interatrial septum HA (S1), the step of arranging the expansion body 21 in the through hole Hh (S2), a step of receiving the biological tissue (S3); a step of confirming hemodynamics in the vicinity of the through hole Hh (S4); a step of grasping the through hole Hh with the expander 21 (S5); It has a step (S6) of performing a maintenance treatment for maintenance, and a step (S7) of confirming the hemodynamics in the vicinity of the through-hole Hh after the maintenance treatment is performed.
  • the operator When forming the through hole Hh, the operator delivers an introducer in which a guiding sheath and a dilator are combined to the vicinity of the interatrial septum HA.
  • the introducer can be delivered to the right atrium HRa, for example, via the inferior vena cava Iv.
  • delivery of the introducer can be done using a guidewire 11 .
  • the operator can pass the guidewire 11 through the dilator and deliver the introducer along the guidewire 11 .
  • the insertion of the introducer into the living body, the insertion of the guide wire 11, and the like can be performed by a known method such as using an introducer for blood vessel introduction.
  • step S1 the operator penetrates a puncture device (not shown) from the right atrium HRa side toward the left atrium HLa side to form a through hole Hh in the fossa ovalis of the interatrial septum HA.
  • a puncture device for example, a device such as a wire with a sharp tip can be used.
  • a puncture device is passed through the dilator and delivered to the atrial septum HA. After removing the guidewire 11 from the dilator, the puncture device can be delivered to the interatrial septum HA instead of the guidewire 11 .
  • a balloon catheter 250 has a balloon 252 at the tip of a shaft portion 251 . Once the balloon 252 is positioned in the interatrial septum HA, it is radially expanded to expand the through hole Hh.
  • step S2 the medical device 10 is delivered near the interatrial septum HA along the pre-inserted guidewire 11 .
  • the distal end of the medical device 10 penetrates the interatrial septum HA and reaches the left atrium HLa.
  • the expansion body 21 is in a state of being housed in the outer cylinder 30 .
  • the medical device 10 may be a device without the outer cylinder 30 .
  • a sheath corresponding to the outer cylinder 30 is separately prepared, and in step S2, the sheath is attached to the guide wire 11 in advance so that the distal end of the sheath reaches the left atrium HLa through the through hole Hh of the interatrial septum HA. along the atrial septum HA.
  • the expandable body 21 of the medical device 10 is inserted into the sheath from the proximal end of the sheath, and the distal end of the expandable body 21 is delivered to the left atrium HLa through the through hole Hh of the interatrial septum HA as in FIG. do.
  • step S3 the expansion body 21 is exposed by moving the outer cylinder 30 to the proximal end side.
  • the expansion body 21 expands in diameter, and the recess 55 is arranged in the through hole Hh of the interatrial septum HA to receive the living tissue surrounding the through hole Hh in the receiving space 74 .
  • the through hole Hh when the through hole Hh is expanded by the balloon 252, the through hole Hh may not be expanded evenly in the radial direction and may have a slit shape.
  • the expansion body 21 expands the through hole Hh in a direction different from the direction in which the slit extends.
  • the hemodynamic confirmation device 200 delivers the hemodynamic confirmation device 200 to the right atrium HRa via the inferior vena cava Iv, as shown in FIG.
  • a known echo catheter can be used as the hemodynamic confirmation device 200.
  • the operator can display the echo image acquired by the hemodynamic confirmation device 200 on a display device such as a display, and confirm the amount of blood passing through the through-hole Hh based on the display result.
  • the operator moves the outer tube 30 to the distal end side to accommodate the expandable body 21 in the outer tube 30, and then moves the outer tube. 30, the expansion body 21 is removed from the through hole Hh.
  • a balloon catheter having a balloon with an expansion diameter larger than that of the balloon 252 used in step S1 the through hole Hh is expanded again, and the process returns to step S2.
  • step S5 the operator operates the operation part 23 while the interatrial septum HA is received in the receiving space 74 of the recess 55, and moves the knob body 111 to the proximal side with respect to the housing 100.
  • the operating knob 110 moves from the initial position shown in FIG. 3 to the compressed position shown in FIG. 4, and the acting portion 114 provided on the operating knob 110 presses the distal end of the elastic body 120 in the proximal direction. Therefore, the proximal end of the elastic body 120 presses the fixed member 170 in the proximal direction, and the displacement shaft 33 fixed to the fixed member 170 moves in the proximal direction.
  • the concave portion 55 of the expansion body 21 sandwiches the living tissue.
  • the operation knob 110 exerts a traction force on the displacement shaft 33 via the elastic body 120 . Therefore, it is possible to prevent the traction force exceeding the force that can be supported by the elastic body 120 from acting on the displacement shaft 33 . That is, when the force with which the expandable body 21 pinches the living tissue is about to become excessive, the elastic body 120 contracts and the compressive force compressing the expandable body 21 in the axial direction is automatically adjusted. As a result, the force that pinches the living tissue is automatically adjusted.
  • the compressive force with which the displacement mechanism 26 compresses the expansion body 21 in the axial direction is not particularly limited, but is preferably 2 to 9N.
  • the knob main body 111 in the initial position is moved to the base end side with respect to the housing 100 and moved to the compressed position, as shown in FIG.
  • the input unit 152 is touched.
  • the pressing input portion 152 is pushed by the contact portion 113 to move and rotate the pressing portion 150 .
  • the pressing output portion 153 pushes the switch body 133 of the detection switch 131 .
  • the movable contact 137 arranged on the switch body 133 contacts both the first fixed contact 135 and the second fixed contact 136 as shown in FIG.
  • the control unit 193 (see FIG. 1) electrically connected to the first fixed contact 135 and the second fixed contact 136 changes the resistance value between the first fixed contact 135 and the second fixed contact 136. , it can be determined that the operation knob 110 has reached the compression position.
  • the control unit 193 determines that the operation knob 110 has reached the compression position, puts the electric power for cauterization into a state in which it can be output, and informs the notification unit 192. (See FIG. 1) to report information indicating that it is ready to output power.
  • step S6 the operator performs maintenance treatment to maintain the size of the through hole Hh.
  • high-frequency energy is applied to the edge of the through-hole Hh through the electrodes 24 to cauterize (heat cauterize) the edge of the through-hole Hh with the high-frequency energy.
  • the operator recognizes that power can be output from the information obtained from the notification unit 192, and uses an interface such as a keyboard, mouse, or dedicated button connected to the control unit 193 to operate the power output unit. 191 to output electric power.
  • the control unit 193 outputs power of 10 to 25 W for a predetermined time (for example, 3 to 45 seconds).
  • the power per unit area of the contact surface of the electrode part 22 is 1.1 to 2.8 W/mm 2 .
  • the control unit 193 stops the power supply when the power output time elapses.
  • the through-hole Hh can maintain its shape when expanded by the expander 21 .
  • the through-hole Hh is held in an appropriate size by the expanding body 21 having a buffer portion for cauterization, so that the through-hole Hh is maintained in an appropriate size and shape. This allows the through hole Hh to be used as a shunt.
  • step S7 After the maintenance treatment, the hemodynamics are confirmed again in step S7, and if the amount of blood passing through the through hole Hh is the desired amount, the operator reduces the diameter of the expandable body 21 and stores it in the outer cylinder 30. After that, it is removed from the through hole Hh. Furthermore, the entire medical device 10 is removed from the body, and the treatment is finished.
  • the medical system 1 includes the expandable body 21 that can be expanded and contracted in the radial direction, the elongated shaft portion 31 having the distal end to which the proximal end of the expandable body 21 is fixed, the expandable body 21, and displaces the proximal end of the expandable body 21 relative to the distal end of the expandable body 21 substantially along the central axis, thereby compressing the expandable body 21 in the axial direction.
  • a displacement mechanism 26 and a power supply device 190 including a control unit 193 that controls the supply of power to the energy transmission unit 22.
  • An inwardly recessed recess 55 is provided, and the recess 55 includes a distal upright portion 72, a proximal upright portion 73, and a distal upright portion 72 so as to define a receiving space 74 capable of receiving living tissue. and a radially innermost bottom portion 71 disposed between and a proximal side upright portion 73 , the distal side upright portion 72 and the proximal side upright portion 73 being expanded by the displacement mechanism 26 .
  • the energy transmission portion 22 is configured to grip the living tissue by compressing the body 21 in the axial direction, and the energy transmission portion 22 is configured to face the receiving space 74 by the distal side upright portion 72 and the proximal side upright portion 73 .
  • the controller 193 applies a power of 1.1 to 2.8 W/mm 2 to the energy transmission section 22 when the expander 21 is axially compressed by the displacement mechanism 26 . It is configured to supply power for 3 to 45 seconds.
  • the living tissue is grasped by the distal side upright portion 72 and the proximal side upright portion 73 forming the concave portion 55 of the expandable body 21, and the distal side upright portion 72 or the proximal side upright portion 73 is held.
  • a desired ablation depth (for example, 1.0 to 2.0 mm degree) can be obtained, and a stable shunt can be formed.
  • control unit 193 supplies electric power corresponding to 1.1 to 2.8 W/mm 2 to the energy transmission unit 22 for 5 to 25 seconds while the expandable body 21 is axially compressed by the displacement mechanism 26 . may This results in a more desirable ablation depth and a more stable shunt formation.
  • the compressive force with which the displacement mechanism 26 compresses the extension body 21 in the axial direction is 2 to 9N.
  • the invention also provides a method of using the medical system 1 .
  • the method of using the medical system 1 includes an expandable body 21 having a central axis and being radially expandable, an elongated shaft portion 31 having a distal end to which the base end of the expandable body 21 is fixed, and and a displacement mechanism that compresses the expansion body 21 in the axial direction by relatively displacing the proximal end of the expansion body 21 with respect to the distal end of the expansion body 21 substantially along the central axis. 26, wherein the expansion body 21 has a recess 55 that is recessed radially inward in the middle of the axial direction, and the recess 55 is a receiving space 74 that can receive living tissue.
  • the energy transmission portion 22 is positioned along either one of the distal uprights 72 and the proximal uprights 73 to face the receiving space 74 and is extended by the displacement mechanism 26 .
  • the distance between the distal side upright portion 72 and the proximal side upright portion 73 is reduced along the axial direction, and the receiving space 74 is axially compressed, and the receiving space 74 is compressed.
  • power corresponding to 1.1 to 2.8 W/mm 2 is supplied to the energy transmission section 22 for 3 to 45 seconds.
  • the method of using the medical system 1 configured as described above is to grasp the living tissue by the distal side upright portion 72 and the proximal side upright portion 73 forming the concave portion 55 of the expandable body 21, and hold the distal side upright portion 72.
  • a desired ablation depth is obtained and stable shunt is achieved. can be formed.
  • the experimental apparatus 300 includes a simulated heart tank 320 in which a test tissue 310 is arranged to simulate a heart, a roller pump 330 for circulating physiological saline, a constant temperature bath 340 for keeping the temperature of the physiological saline constant, and a physiological and a channel 350 for refluxing saline solution.
  • the salt concentration of the physiological saline was 0.9 mass percent.
  • the simulated heart reservoir 320 includes a tissue fixing portion 321 for fixing the test tissue 310 , a first inlet 323 and a first outlet 324 provided in a first reservoir 322 on one side of the test tissue 310 , and a test tissue 310 . It had a second inflow port 326 and a second outflow port 327 provided in the second tank 325 on the other side with the tissue 310 interposed therebetween. A second row 325 was arranged above the first row 322 .
  • the physiological saline pressurized by the roller pump 330 flows through the flow path 350 into the constant temperature bath 340, is heated to 37° C., and then splits to flow from the first inlet 323 and the second inlet 326 to the first inlet.
  • the physiological saline solution that has flowed into the first tank 322 and the second tank 325 flows out from the first outlet 324 and the second outlet 327 into the flow path 350, joins together, returns to the roller pump 330, and is pressurized again.
  • the flow rate of roller pump 330 was 850 mL/min.
  • the puncture device was inserted into the second tank 325 from above to puncture the test tissue 310 to form a through hole.
  • the puncture device was removed, a balloon was inserted into the second tank 325 from above, and the through-hole of the test tissue 310 was expanded by the balloon.
  • the balloon was removed, the medical device 10 to be tested was inserted into the second tank 325 from above, and the expandable body 21 was placed in the through hole of the concave portion 55 of the expandable body 21 to perform maintenance treatment.
  • the compression force for axially compressing the expansion body 21 at this time was 5N.
  • each electrode 24 capable of supplying electric power in contact with the living tissue had a width of 0.75 mm and a length of 4 mm, as in the example of the above-described embodiment. Therefore, the area of the electrode surface of each electrode 24 was 3 mm 2 , and the total area of the electrode surfaces of the six electrodes 24 was 18 mm 2 .
  • the test tissue 310 that has undergone maintenance treatment under each condition is removed from the experimental device 300, the test tissue 310 is cut along the thickness direction, and the cross-sectional tissue is observed to observe the cauterization depth (cauterized and discolored tissue , the depth from the contact position with the electrode 24) was measured at six points, and the average value was calculated.
  • a graph showing ablation depth versus applied power is shown in FIG. Further, FIG. 15 shows a graph showing the cauterization depth with respect to the applied power per unit area of the energy transmission part 22 . 14 and 15, when the applied power is 10 to 25 W and the applied power per unit area is 1.1 to 2.8 W/mm 2 , a deep ablation depth of about 1.0 to 2.0 mm can be obtained. was confirmed.
  • Fig. 16 shows the results of measuring the impedance with respect to the application time. As a result, it was confirmed that the impedance decreased to some extent when the application time was 3 seconds, and the impedance sufficiently decreased when the application time was 5 seconds, and the cauterization progressed sufficiently. In addition, at 25 seconds, cauterization progressed until the impedance increased sharply in all experiments except 3 cases, and at 45 seconds, in all experiments except 1 case, the ablation progressed until impedance increased sharply. confirmed.
  • the operation knob 110 is moved and the switch body 133 of the detection switch 131 is pushed, so that the operator can perform maintenance treatment.
  • the operation knob 110 may be moved to press the switch body 133 via the pressing portion 150, thereby starting the supply of power for maintenance treatment.
  • the switch mechanism is used to directly start and stop power delivery rather than enabling power delivery.
  • the circuit board is provided with a supply circuit 161 for supplying power to the electrode section 22, an output circuit for outputting information as to whether or not the extension body 2 is compressed to the power supply device 190 via the cable 25 is , is not provided unlike the previous embodiment.
  • the first fixed contact 135 is connected to one of the first terminals 163 connected to the power supply section 191
  • the second fixed contact 136 is connected to one of the energy output terminals 164 connected to the electrode section 22 . conduct.
  • the other of the first terminals 163 and the other of the energy output terminals 164 are directly connected.
  • the switch body 133 is pushed in, the movable contact 137 contacts both the first fixed contact 135 and the second fixed contact 136, and the first terminal 163 and the energy output terminal are connected. 164 are electrically connected. As a result, the supply of electric power to the energy transfer section 22 is started. Also, when the operator moves the operation knob 110 from the compressed position toward the initial position, the switch body 133 returns, the movable contact 137 separates from both the first fixed contact 135 and the second fixed contact 136, and the electric power is released. supply is stopped.
  • the second connecting portion 53 and the first connecting portion 54 of the expansion body 21 may have separate structures.
  • the distal side upright portion 72 and the bottom portion 71 are arranged in the second connecting portion 53
  • the proximal side upright portion 73 is arranged in the first connecting portion 54 .
  • a receiving space 74 for the recess 55 is defined by the distal upright portion 72 , the bottom portion 71 and the proximal upright portion 73 .
  • the bottom portion 71 may be arranged on the first connecting portion 54 .
  • the energy transmission part 22 is arranged on the first connecting part 54 , but may be arranged on the second connecting part 53 .
  • the first connecting portion 54 and the second connecting portion 53 are accommodated in the outer cylinder 30 in an elastically deformed and contracted state. force).
  • the shaft portion 31 is fixed to the proximal end of the first connecting portion 54
  • the displacement shaft 33 is fixed to the proximal end of the second connecting portion 53 .
  • the displacement shaft 33 is slidable inside the shaft portion 31 . Therefore, the displacement mechanism that axially compresses the expansion body 21 is a mechanism that pulls the displacement shaft 33 toward the proximal side or pushes the shaft portion 31 toward the distal side.
  • the distal side upright portion 72 and the proximal side upright portion 73 are brought closer to each other, the receiving space 74 is reduced, and the distal side upright portion 72 and the proximal side are separated from each other.
  • the interatrial septum HA which is a living tissue, can be grasped between the upright portion 73 and the upright portion 73 .

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Abstract

L'invention concerne un système médical et son procédé d'utilisation permettant l'obtention d'une profondeur de cautérisation recherchée et la formation d'un pontage stable.　Ce système médical (1) comprend : un dispositif médical (10) comprenant un corps expansible (21), une partie corps (31) à laquelle une extrémité de base du corps expansible (21) est fixée, une partie de transmission d'électricité (22) disposée le long du corps expansible (21), et un mécanisme de déplacement (26) destiné à comprimer le corps expansible (21) dans la direction axiale ; et un dispositif d'alimentation électrique (190) comprenant une unité de commande (193) qui commande l'alimentation en électricité de la partie de transmission d'électricité (22), une partie verticale côté extrémité distale (72) et une partie verticale côté extrémité de base (73) formant un évidement (55) à mi-chemin dans la direction axiale du corps expansible (21) étant conçues pour saisir un tissu biologique par compression dans la direction axiale du corps expansible (21) au moyen du mécanisme de déplacement (26), la partie de transmission d'électricité (22) étant disposée le long de la partie verticale côté extrémité de base (73), et l'unité de commande (193) fournissant de l'énergie correspondant à 1,1 à 2,8 W/mm2 pendant 3 à 45 secondes à la partie de transmission d'électricité (22) alors que le corps expansible (21) est comprimé dans la direction axiale par le mécanisme de déplacement.
PCT/JP2023/003336 2022-02-04 2023-02-02 Système médical et son procédé d'utilisation WO2023149496A1 (fr)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019502471A (ja) * 2016-01-05 2019-01-31 カーディオフォーカス，インコーポレーテッド 自動化されたスイープするアブレーションエネルギー構成要素を有するアブレーションシステム
WO2020259492A1 (fr) * 2019-06-25 2020-12-30 杭州诺生医疗科技有限公司 Dispositif de septostomie auriculaire
WO2021065876A1 (fr) * 2019-09-30 2021-04-08 テルモ株式会社 Dispositif de génération d'énergie et système de cautérisation

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019502471A (ja) * 2016-01-05 2019-01-31 カーディオフォーカス，インコーポレーテッド 自動化されたスイープするアブレーションエネルギー構成要素を有するアブレーションシステム
WO2020259492A1 (fr) * 2019-06-25 2020-12-30 杭州诺生医疗科技有限公司 Dispositif de septostomie auriculaire
WO2021065876A1 (fr) * 2019-09-30 2021-04-08 テルモ株式会社 Dispositif de génération d'énergie et système de cautérisation

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