WO2021033275A1 - Dispositif de cathéter et méthode de traitement - Google Patents

Dispositif de cathéter et méthode de traitement Download PDF

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Publication number
WO2021033275A1
WO2021033275A1 PCT/JP2019/032506 JP2019032506W WO2021033275A1 WO 2021033275 A1 WO2021033275 A1 WO 2021033275A1 JP 2019032506 W JP2019032506 W JP 2019032506W WO 2021033275 A1 WO2021033275 A1 WO 2021033275A1
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WO
WIPO (PCT)
Prior art keywords
shape
catheter device
shaft portion
energy
blood vessel
Prior art date
Application number
PCT/JP2019/032506
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English (en)
Japanese (ja)
Inventor
知幸 田島
翔平 松原
嘉気 渡部
Original Assignee
株式会社Ａｌｉｖａｓ
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Application filed by 株式会社Ａｌｉｖａｓ filed Critical 株式会社Ａｌｉｖａｓ
Priority to PCT/JP2019/032506 priority Critical patent/WO2021033275A1/fr
Publication of WO2021033275A1 publication Critical patent/WO2021033275A1/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
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • 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

Definitions

  • the present invention relates to a catheter device and a treatment method.
  • a catheter device used for irradiating energy such as heat in a living lumen such as a blood vessel to treat or improve various diseases has been known.
  • a technique of cauterizing a nerve existing outside a blood vessel is carried out (see, for example, Patent Document 1).
  • the renal artery is selected as the blood vessel to be treated, and the catheter device is held in order to enable the catheter device to be held in the blood vessel during the treatment.
  • a geometric shape such as a spiral shape may be added to the shaft portion.
  • the shaft portion of the catheter device When performing treatment in a living lumen such as a blood vessel, it is preferable to make the outer shape of the shaft portion of the catheter device as small as possible to improve its deliveryability when delivering into the living lumen.
  • the shaft portion was provided on the shaft portion by shifting the position of the shaft portion from a desired position on the tube wall of the biological lumen during the treatment. It is preferable to prevent the energy radiating portion (for example, a heat source to which heat energy is applied) from being arranged at a position different from the treatment target portion.
  • the shaft portion of the catheter device when a part of the shaft portion of the catheter device is geometrically shaped such as a spiral shape, the shaft portion has a spiral shape after being delivered into the biological lumen. A plurality of points on the outer surface of the portion come into contact with the tube wall (wall portion) of the biological lumen. Therefore, it seems that the displacement of the shaft portion can be suppressed during the procedure using the catheter device.
  • the spirally formed shaft portion is premised on the fact that the living lumen (for example, a blood vessel) has a right cylindrical shape. Contrary to this assumption, if the biological lumen to be treated is highly bent, it may not be possible to exert a sufficient holding force on the tube wall of the biological lumen. Further, in order for the spiral shape to exert its holding power, it is necessary that at least one circumference of the spiral shape is contained in the lumen of the living body. Therefore, it is premised that the biological lumen to be treated has a certain length of extension that enables the arrangement of one spiral-shaped circumference as described above.
  • the present invention has been made based on the above-mentioned problems, and it is possible to increase the holding force of the shaft portion with respect to the tube wall of the biological lumen, and more accurately with respect to the treatment target site of the biological lumen. It is an object of the present invention to provide a catheter device capable of irradiating energy and a treatment method.
  • the catheter device includes an energy radiating portion capable of radiating energy in a biological lumen, a first portion in which at least a part of the energy radiating portion is arranged, and a tip of the first portion. It has a second portion located on the side and has a shaft portion that can be inserted into the biological lumen, and the shaft portion is provided on at least a part of the tip portion of the second portion. It can be transformed into a first shape in which a folded portion folded in the axial direction is formed, and a second shape in which at least a part of the folded portion of the second portion is extended substantially linearly.
  • the position of the shaft portion in the biological lumen can be easily adjusted without using a guide wire or the like. Can be done. Further, by deforming the second part of the shaft portion into the second shape in the living lumen, the substantially linearly extended portion of the second part is brought into contact with the tube wall of the living lumen. Can be done. Therefore, the holding force of the shaft portion with respect to the tube wall of the biological lumen can be increased. For example, even when the shaft portion cannot be backed up using a guiding catheter or the like, the shaft portion is positioned from the tube wall of the biological lumen. It is possible to effectively suppress the deviation.
  • FIG. 8 is a flowchart showing an example of a procedure for treatment using the catheter device 100.
  • 9 and 10 are diagrams for explaining the blood vessel V which is the target of the treatment method using the catheter device 100.
  • 11 to 13 are views for explaining a usage example of the catheter device 100. Note that FIG. 13 shows a cross section of the blood vessel V along a direction orthogonal to the traveling direction of the blood vessel V (direction indicated by arrows 13A-13A in FIG. 12).
  • the arrow X1 in the figure indicates the insertion direction of the catheter device 100 into the blood vessel V
  • the arrow X2 in the figure indicates the direction opposite to the insertion direction
  • arrows Y1-Y2 in the figure indicate directions orthogonal to arrows X1-X2
  • arrows Z1-Z2 in the figure indicate directions orthogonal to the respective directions of arrows X1-X2 and arrows Y1-Y2.
  • the treatment target site S will be described with reference to FIGS. 9 and 10.
  • the symbol VR indicates the right renal artery
  • the symbol VL indicates the left renal artery.
  • the symbol Va indicates the superior mesenteric artery
  • the symbol Vb indicates the celiac artery
  • the symbol Vc indicates the inferior mesenteric artery
  • the symbol Vd indicates the aorta.
  • an operator such as a doctor (hereinafter referred to as “operator”) has an autonomic nerve in a blood vessel V having a peripheral nerve (nerve plexus) Na that innervates the intestinal tract of the patient.
  • the peristaltic movement of the intestinal tract is enhanced.
  • the surgeon performs at least one symptom of abdominal bloating, abdominal pain, peristal discomfort, and frequent stools due to constipation and / or abnormal peristaltic movement of the intestinal tract. Relief of constipation in patients and / or at least one of the symptoms caused by abnormal peristaltic movements of the intestinal tract can be promoted.
  • the blood vessel V to which the treatment method is applied may be capable of enhancing the peristaltic movement of the intestinal tract of the patient (subject) by being subjected to the predetermined treatment according to the embodiment (energy is applied by electromagnetic waves described later).
  • energy is applied by electromagnetic waves described later.
  • the blood vessel V for example, at least one of superior mesenteric artery Va, celiac artery Vb, and inferior mesenteric artery Vc can be preferably selected.
  • the surgeon applies energy to one peripheral nerve Na or a plurality of peripheral nerve Nas.
  • the operator can enhance the peristaltic movement of the intestinal tract by damaging the peripheral nerve Na and completely or partially blocking the autonomic nerve transmission to the digestive tract by the peripheral nerve Na.
  • the following mechanism is considered as the reason why the peristaltic movement of the intestinal tract is activated by performing the above-mentioned treatment for reducing the activity of the autonomic nerve in the blood vessel V.
  • the sympathetic nervous system among the sympathetic nervous system and the parasympathetic nervous system becomes It is relatively weakened and becomes parasympathetic dominant.
  • the enteric nervous system that autonomously controls intestinal motility in the periphery becomes dominant, and intestinal peristalsis is activated.
  • activation of intestinal peristalsis promotes and normalizes colonic transit time, resulting in abdominal bloating, abdominal pain, perineal discomfort, and frequent stools due to constipation and / or abnormal intestinal peristalsis. Relief of at least one of these symptoms is promoted.
  • the intestinal peristaltic movement of the large intestine is reduced, and as a result, the passage time of the stool is delayed, resulting in constipation. It can preferably promote the relief of the symptoms of constipation with delayed colonic transit time.
  • the treatment target site (region containing one or more peripheral nerve Na) S to be treated in the blood vessel V is not particularly limited as long as it can enhance the peristaltic movement of the intestinal tract.
  • treatment may be performed on an arbitrary range (site) of the traveling direction (extending direction) of the blood vessel V, or in the circumferential direction of the blood vessel V (circumferential direction of the cross section). Treatment may be performed on the range (site) of.
  • the treatment may be performed a plurality of times on a plurality of locations of the same blood vessel V, or may be performed a plurality of times on any location of a different blood vessel V.
  • the treatment method according to the present embodiment includes performing treatment on the Vao around the origin of the superior mesenteric artery Va.
  • an example of the range of the treatment target site S existing outside the superior mesenteric artery Va will be described with reference to FIG.
  • the treatment target site S preferably includes a range of 0 mm to 20 mm (range indicated by reference numeral L1) along the extension direction of the superior mesenteric artery Va with reference to the opening of the superior mesenteric artery Va.
  • the treatment target site S is based on the bifurcation of the superior mesenteric artery Va.
  • a range of 0 mm to 100 mm (range indicated by reference numeral L2) along the extension direction of the aorta Vd may be included.
  • the depth of energy penetration from the superior mesenteric artery Va side is preferably at least 1 mm to 6 mm from the intima of the superior mesenteric artery Va.
  • the peripheral nerve Na existing outside the superior mesenteric artery Va exists at a relatively deep position in the Vao around the origin of the superior mesenteric artery Va. More specifically, the peripheral nerve Na is present in bundles in the adipose tissue outside the superior mesenteric artery Va, supported by connective tissue.
  • the peripheral nerve Na is efficiently removed by allowing the energy to reach a position of 1 mm to 6 mm in the intima of each blood vessel Va and Vd. Can be nervous.
  • the catheter device 100 As shown in FIGS. 1 to 7, the catheter device 100 according to the present embodiment is roughly described by an energy radiating unit 150 capable of radiating energy in a blood vessel V (corresponding to a “living cavity”) and energy radiating. It has a first portion 111 in which at least a part of the portion 150 is arranged and a second portion 112 located on the distal end side of the first portion 111, and has a shaft portion 110 that can be inserted into the blood vessel V.
  • an energy radiating unit 150 capable of radiating energy in a blood vessel V (corresponding to a “living cavity”) and energy radiating. It has a first portion 111 in which at least a part of the portion 150 is arranged and a second portion 112 located on the distal end side of the first portion 111, and has a shaft portion 110 that can be inserted into the blood vessel V.
  • the second portion 112 extends continuously toward the tip end side of the first portion 111.
  • a proximal region 113 of the shaft portion 110 is formed on the proximal end side of the first portion 111.
  • the shaft portion 110 is composed of a long and flexible member.
  • the material used for the shaft portion 110 is not particularly limited, but for example, the same material as the resin material used for a known catheter device can be used.
  • the outer diameter, inner diameter, axial length, cross-sectional shape, etc. of the shaft portion 110 are not particularly limited.
  • the second portion 112 of the shaft portion 110 is configured to be deformable into the first shape shown in FIG. 2 and the second shape shown in FIG.
  • the first portion 111 of the shaft portion 110 is maintained in a substantially linear shape along the axial direction of the shaft portion 110 without being deformed due to the deformation of the second portion 112 before and after the deformation of the second portion 112. It is configured.
  • a folded-back portion 112a folded back in the axial direction of the shaft portion 110 is formed in at least a part of the second portion 112.
  • the second portion 112 is wound at least partially in the first shape. More specifically, in the first shape, the second portion 112 including the tip portion of the shaft portion 110 is wound a plurality of times from the tip end side to the base end side in the axial direction of the shaft portion 110 as shown by an arrow b1. As a result, it has a folded portion 112a having a rounded outer shape.
  • the tip of the second portion 112 of the shaft portion 110 may be shaped in the first shape so as to face, for example, the proximal end direction of the shaft portion 110 (direction of arrow X2 in FIG. 2). it can.
  • the specific shape of the first shape is not limited as long as the "folded portion folded at least once on the base end side and / or the tip end side in the axial direction of the shaft portion" is formed.
  • the second shape exhibits a shape in which at least a part of the folded-back portion 112a of the second portion 112 is extended in a substantially straight line.
  • the second portion 112 in the second shape, extends substantially linearly as a whole by unwinding the winding shaped in the first shape.
  • the second portion 112 is arranged at a position where the axial center C2 at the tip of the second portion 112 is eccentric from the axial center C2 of the first portion 111 in the first shape.
  • the axial center C1 and the axial center C2 are arranged so as not to overlap each other in the arrow Y1-Y2 direction perpendicular to the arrow X1-X2 along the axial direction of the shaft portion 110. There is.
  • the second portion 112 is arranged at a position where the axial center C1 at the tip of the second portion 112 overlaps with the axial center C1 of the first portion 111 in the second shape.
  • the axis C1 and the axis C2 are arranged so as to overlap each other in the directions of arrows Y1-Y2 (overlap from the upper surface in projection view).
  • the second portion 112 is arranged at a position where the axial center C1 at the tip of the second portion 112 is separated from the axial center C1 of the first portion 111 in the direction of arrows Z1-Z2.
  • the second portion 112 extends substantially linearly in the second shape so that the distance between the first portion 111 and the axial center C1 gradually increases toward the proximal end side. Therefore, by deforming the second site 112 into the second shape in the blood vessel V, the second site 112 can be more reliably brought into contact with the tube wall Vai of the blood vessel V (see FIG. 12).
  • the second portion 112 has a curved portion 114 that curves with a predetermined curvature between the first portion 111 and the second portion 112 in the second shape.
  • the second portion 112 extends from the curved portion 114 on the tip end side of the shaft portion 110 so as to be separated from the first portion 111. Therefore, when the second portion 112 is deformed into the second shape, the first portion 111 and the second portion 112 exhibit a substantially U-shape facing each other with the curved portion 114 in between.
  • the curvature, length, range, etc. of the curved portion 114 are not particularly limited.
  • the shaft portion 110 places each of the first portion 111 and the second portion 112 at different positions in the circumferential direction of the tube wall Vai of the blood vessel V. It is configured so that it can come into contact with the water.
  • the first portion 111 and the second portion 112 can face each other on the cross section shown in FIG.
  • the first site 111 and the second site 112 can be arranged in a positional relationship facing each other with the center position O of the blood vessel V in between.
  • the electromagnetic wave radiated from the energy radiating portion (antenna element) 150 arranged in the first portion 111 is arranged in the second portion 112 of the reflector 130 (tube).
  • the body 140) can reflect to the first portion 111 side.
  • the electromagnetic wave radiated from the antenna element 150 and the electromagnetic wave reflected by the reflector 130 are subjected to the treatment target site S containing the peripheral nerve Na existing outside the tube wall Vai of the blood vessel V with which the first site 111 is in contact. It becomes possible to irradiate the body locally.
  • the first site 111 and the second site 112 do not have to be arranged at positions that strictly face each other on the cross section of the blood vessel V. Further, when the energy emitting unit 150 has a structure other than the antenna element capable of radiating electromagnetic waves, the arrangement of the reflector 130 on the second portion 112 can be omitted. Even when the catheter device 100 is configured in this way, the first portion 111 extending substantially linearly and the second portion 112 deformed into a second shape and extending substantially linearly are provided along the extending direction of the blood vessel V. The holding force of the shaft portion 110 on the blood vessel V can be increased by bringing it into contact with the tube wall Vai over a predetermined length.
  • FIG. 4 shows a side view of the shaft portion 110 of the second portion 112 of the first shape
  • FIG. 5 shows a partial cross-sectional view of the shaft portion 110 in the state shown in FIG.
  • FIG. 6 shows a side view of the shaft portion 110 of the second portion 112 of the second shape
  • FIG. 7 shows a partial cross-sectional view of the shaft portion 110 in the state shown in FIG.
  • the energy radiating unit 150 can be configured by an antenna element 150 capable of radiating electromagnetic waves.
  • the energy radiating unit 150 is also referred to as an antenna element 150.
  • a reflector 130 capable of reflecting electromagnetic waves radiated from the antenna element 150 can be arranged at least a part of the second portion 112. As shown in FIG. 7, at least a part of the reflector 130 can be arranged at a position facing the antenna element 150 in the second shape.
  • the second portion 112 is provided with a restraining member 140 that suppresses the second portion 112 from being twisted when the second portion 112 is deformed into the second shape.
  • the restraining member 140 is composed of a tubular body 140 including a plurality of metal knot rings 141 and 142 oscillatingly connected to each other.
  • the tubular body 140 has a function as a reflector 130.
  • the knot rings 141 and 142 adjacent to each other in the longitudinal direction of the pipe body 140 are connected to each other via the convex portion 143 and the concave portion 144.
  • the convex portion 143 is idled in the concave portion 144 and can swing along the inner surface of the concave portion 144.
  • Each of the nodal rings 141 and 142 has a hollow ring shape.
  • the knots 141 and 142 are provided with an inclined surface 145 for regulating the bending direction of the pipe body 140.
  • the operation of the adjacent knot rings 141 and 142 is limited to the range in which the inclined surface 145 is formed. Therefore, the tubular body 140 can be curved in the direction of arrow r1 shown in FIG.
  • the tubular body 140 when the tubular body 140 tries to swing in the direction of arrow r2 in the direction opposite to that of arrow r1, the swing is regulated by the regulating surfaces 146 formed on the nodal rings 141 and 142. Therefore, when the second portion 112 is deformed into the second shape, the tubular body 140 can be easily deformed into the substantially linear shape shown in FIG. 7, and the second portion 112 is warped outward. It is possible to suppress the deformation to.
  • the catheter device 100 can suppress the twisting of the second site 112 when the second site 112 is deformed into the second shape in the blood vessel V. Therefore, the second portion 112 can be more reliably brought into contact with the tube wall of the blood vessel V over the length direction thereof.
  • the specific shape of the restraining member 140 is not limited as long as it can prevent the second portion 112 from being twisted when the second portion 112 is deformed into the second shape.
  • the restraining member 140 may be composed of, for example, a metal rod-shaped member or a metal flat plate-shaped member.
  • the shaft portion 110 has a resin tube 120 constituting the shaft portion 110.
  • the tube body 140 and the antenna element 150 are interpolated inside the shaft portion 110.
  • the tube 120 can be made of, for example, a tubular member made of a known resin.
  • the antenna element 150 can be configured to have, for example, a helical element 151 capable of radiating microwaves as an electromagnetic wave.
  • the reflector 130 is arranged at a second portion 112 away from the first portion 111 where the antenna element 150 is arranged. By arranging the reflector 130 away from the antenna element 150, the reflector 130 is arranged inside the shaft portion 110 together with the antenna element 150, while the reflector 130 is not electrically connected to the antenna element 150 and is in a non-energized state. Can be maintained.
  • a coaxial cable 160 is arranged inside the shaft portion 110.
  • the tip of the coaxial cable 160 is not covered with the outer conductor, and the inner conductor (center conductor) 161 and the dielectric (not shown) are led out to the tip side of the coaxial cable 160 by a predetermined length.
  • a connecting portion 163 is arranged at the tip of the inner conductor 161.
  • the tip of the helical element 151 is electrically connected to the connecting portion 163 to form a helical antenna.
  • a balun 165 that converts an electric signal in a balanced and unbalanced state is arranged on the coaxial cable 160.
  • the antenna element 150 radiates electromagnetic waves by receiving an electric current via the coaxial cable 160.
  • the antenna element 150 is composed of a structure (helical element 151, a part of the internal conductor 161 and a connecting portion 163) located on the tip side of the internal conductor 161 with respect to the portion protruding from the coaxial cable 160. There is.
  • the center frequency of the antenna element 150 can be set to, for example, 915 MHz, 2.45 GHz, 5.8 GHz, or 24.125 GHz. it can.
  • Each structure constituting the antenna element 150 is not particularly limited in structure, shape, frequency and material of the radiated electromagnetic wave, arrangement form in the shaft portion 110, etc. as long as it can radiate electromagnetic waves.
  • the spiral winding direction of the helical element 151 may be either the forward direction or the reverse direction, and the number of windings is not particularly limited.
  • the axial length of the helical element 151 is not particularly limited.
  • the helical element 151 can be made of, for example, a platinum alloy.
  • the reflector 130 can be made of, for example, a known metal.
  • the metal for example, copper, aluminum, stainless steel, platinum alloy, shape memory alloy and the like can be used.
  • the material constituting the reflector 130 is made of, for example, nickel from the viewpoint of maintaining the shape of the tip of the shaft portion 110 in the shape shown in FIG. 2 in a natural state in which no external force is applied to the second portion 112. It is preferable to use a shape memory alloy such as a titanium alloy.
  • the reflector 130 can also be composed of a metal reinforcing wire (blade wire) provided on the shaft portion 110.
  • a metal reinforcing wire is provided on the shaft portion 110, the reinforcing wire is the first portion 111 on which the antenna element 150 is arranged so that the radiation characteristics of the electromagnetic waves radiated from the antenna element 150 are not significantly impaired.
  • the antenna is not arranged in the entire circumferential direction and the axial direction.
  • the reflector 130 is not particularly limited as long as it can reflect electromagnetic waves, and is composed of a metal member other than the tube body 140 having a plurality of nodal rings 141 and 142. It is also possible (see FIG. 15).
  • the energy radiating unit 150 may be configured by other than the antenna element 150 capable of radiating electromagnetic waves.
  • the energy radiating unit 150 can radiate, for example, ultrasonic waves, light, heat, cold radiation, magnetic, electrical, cryotherapy, plasma, chemical energy, potential energy, nuclear energy, hydromechanical energy, and the like. It may have a structure.
  • a filler 123 for suppressing the movement of the antenna element 150 in the shaft portion 110 is arranged inside the shaft portion 110.
  • the filler 123 can be made of a known resin material.
  • the filler 123 is formed with a passage 123a for enabling the movement of the traction member 171 described later.
  • the catheter device 100 has an operation unit for deforming the second portion 112 of the shaft portion 110 from the first shape to the second shape.
  • the operation unit has a hand-side operation member 170 (see FIG. 1) and a traction member 171 (see FIGS. 5 and 7) arranged on the hub 180 of the catheter device 100.
  • the traction member 171 is a long member that is fixed to the tip of the shaft portion 110 and can reversibly deform the shaft portion 110 from the first shape to the second shape by a push-pull operation at hand. It is composed of.
  • the tip of the traction member 171 is fixed to the outer surface of the tip of the tube 140 arranged at the tip of the shaft 110. Further, the base end portion of the traction member 171 is fixed to the hand side operating member 170 arranged on the hub 180.
  • the specific configuration of the hand side operating member 170 is not particularly limited, but for example, it can be configured by a handle mechanism capable of pushing and pulling the traction member 171 in conjunction with a rotation operation and an advance / retreat operation.
  • the material, outer diameter, cross-sectional shape, etc. of the traction member 171 are not particularly limited as long as the force generated when the operator operates the hand side operating member 170 can be transmitted to the tip end side of the shaft portion 110.
  • the hand side operation member 170 may be provided with a lock mechanism for holding the towed member 171 in a towed state and holding the towed member 171 in a released state.
  • the second portion 112 of the shaft portion 110 is shaped so as to form the first shape as shown in FIGS. 4 and 5 in a natural state in which no external force (traction force) is applied to the traction member 171. ..
  • the traction force is transmitted to the tip of the tubular body 140, and the second portion 112 is the second as shown in FIGS. 6 and 7. It transforms into a shape.
  • the shaft portion 110 has an axial center C1 at the tip of the second portion 112 and an axial center C2 at the first portion 111 substantially along the axial direction.
  • the shaft portion 110 can be reversibly deformed so as to return from the second shape to the first shape when the application of the traction force transmitted via the traction member 171 is released.
  • the tube 120 of the shaft portion 110 can be habituated to form the first shape.
  • the second portion 112 may be configured to have the first shape in a natural state. ..
  • the traction member 171 can insert a part of the filler 123 and the pipe body 140 and lead the traction member 171 to the outer surface side of the pipe body 140 near the tip of the second portion 112. it can.
  • the traction member 171 is located near the first portion 111 in order to reversibly and smoothly deform the second portion 112 from the first shape to the second shape in conjunction with the traction operation of the traction member 171. Then, it passes through a position eccentric from the axis C1, passes through a substantially center position of the shaft portion 110 at the position where the filler 123 is inserted, and passes through a position eccentric from the axis C2 of the second portion 112 on the tip side of the tubular body 140.
  • the arrangement of the traction member 171 shown in FIG. 7 is merely an example, and is not limited to such an arrangement.
  • the method of manipulating the deformation of the second portion 112 of the shaft portion 110 is not limited to only applying and releasing the physical traction force using the traction member 171.
  • the traction member 171 may be made of an alloy having a temperature responsiveness that deforms into the first shape and the second shape in response to a temperature change or the like, and may be deformed by adjusting the temperature. ..
  • a tip tip 115 can be attached to the tip of the shaft portion 110.
  • the tip 115 can be made of, for example, a flexible resin material.
  • the tip tip 115 can be fixed to the tip of the shaft portion 110 with the fixing member 115a.
  • the fixing member 115a can be made of, for example, a known resin material.
  • the shaft portion 110 is not formed with a guide wire lumen for inserting a guide wire used for guiding the movement of the catheter device 100 in a living body. Therefore, the shaft portion 110 can be made smaller.
  • the antenna element 150 is adopted as the energy radiating portion, and the reflector 130 is further arranged on the shaft portion 110 so that the electromagnetic wave radiated from the antenna element 150 is directed in a predetermined direction on the cross section of the blood vessel V. It is configured so that it can be irradiated locally (see FIG. 13).
  • the catheter device 100 configured in this way, when electromagnetic waves are radiated from the antenna element 150 with the guide wire inserted in the shaft portion 110, it is difficult to control the radiation direction of the electromagnetic waves by the guide wire containing metal in the constituent members. become. Therefore, the shaft portion 110 is not provided with a guide wire lumen for inserting the guide wire.
  • the catheter device 100 according to the present embodiment is shaped so that the second portion 112 located at the tip end portion of the shaft portion 110 has the first shape having the folded-back portion 112a. Even when the guide wire is not used, the operator can easily and smoothly position the tip of the shaft portion 110 in the blood vessel V (see FIG. 11).
  • the catheter device 100 can have a structure in which the guide wire lumen is not formed on the shaft portion 110.
  • the shaft portion 110 may be configured to include, for example, a lumen through which the guide wire and various media can pass, in addition to the lumen in which the antenna element 150 is arranged.
  • a port for communicating inside and outside the shaft portion 110 is provided at the tip of the shaft portion 110 so that the guide wire can be inserted only in the vicinity of the tip of the shaft portion 110. be able to.
  • the emission of electromagnetic waves by the antenna element 150 can be controlled via, for example, a predetermined controller (control device) 200.
  • the controller 200 can be electrically connected to the coaxial cable 160 via, for example, an electric wire led out from a hub 180 provided in the catheter device 100.
  • the controller 200 for example, a known control device including a CPU and a storage unit can be used.
  • the storage unit includes a ROM for storing various programs and data, a RAM for temporarily storing programs and data as a work area, a hard disk capable of storing various programs and data, and the like.
  • a series of programs necessary for controlling the operation of the catheter device 100 can be stored in the storage unit.
  • the transmission form of the operation command to the antenna element 150 for example, a wired one via a telecommunication line, a wireless one not via the telecommunication line, an operator via an operation unit incorporated in the controller, or the like.
  • the treatment using the antenna element 150 is performed by, for example, a medical device such as a treatment robot that substitutes the work by the operator. It may be carried out. In this case, the treatment may be performed by an operator or the like controlling the treatment robot at a medical site such as an operating room, or by controlling the treatment robot at a remote location.
  • a device 10 in which a catheter device 100 and a controller 200 are combined is provided as a medical device used for a predetermined treatment by radiating electromagnetic waves in a biological lumen such as a blood vessel V. can do.
  • the catheter device 100 is used for a procedure of enhancing the peristaltic movement of the intestinal tract by applying energy to the peripheral nerve Na running around the blood vessel V (superior mesenteric artery Va) and damaging the peripheral nerve Na.
  • V blood vessel
  • An example of doing so will be described.
  • the treatment procedure described in the present specification is only an example, and for example, some procedures, procedures not particularly described, medical devices other than the catheter device 100 used in the procedure, and the like are known in the medical field. It is possible to adopt the thing as appropriate.
  • the treatment method according to the present embodiment includes a first portion 111 in which at least a part of the energy radiating portion 150 capable of radiating energy is arranged, and a second portion 112 located on the tip side of the first portion 111. It has a first step of inserting the catheter device 100 including the shaft portion 110 having the above into the blood vessel V, and a second step of radiating energy from the energy radiating unit 150 in the blood vessel V. Then, in the first step, at least a folded portion 112a of the second portion 112 from the first shape in which the folded portion 112a folded back in the axial direction of the shaft portion 110 is formed at least a part of the tip portion of the second portion 112. Includes transforming the second portion 112 into a second shape that is partially elongated in a substantially linear shape.
  • the catheter device 100 is delivered into the blood vessel V (S11), and the second site 112 of the shaft portion 110 is arranged in the blood vessel V in the first shape. That (S12), the second portion 112 of the shaft portion 110 is deformed from the first shape to the second shape (S13), and the shaft portion 110 is brought into contact with the tube wall Vai of the blood vessel V (S14). , To radiate an electromagnetic wave from the antenna element 150 (S15).
  • the operator uses a known guiding catheter 300 to deliver the catheter device 100 to the blood vessel V.
  • the operator manipulates the traction member 171 to deform the second site 112 into an elongated shape.
  • the first portion 111 and the second portion 112 of the shaft portion 110 extend substantially linearly and are reduced in diameter. The operator can deliver the tip of the shaft 110 into the blood vessel V in a reduced diameter state.
  • the operator projects the shaft portion 110 by a predetermined length from the tip opening of the guiding catheter 300.
  • the second site 112 protrudes from the tip opening of the guiding catheter 300, it deforms into the first shape as shown in FIG.
  • the operator operates the hand-side operating member 170 to deform the second portion 112 from the first shape to the second shape, as shown in FIG.
  • the operator brings the first site 111 and the second site 112 into contact with the tube wall Vai of the blood vessel V.
  • the second portion 112 in which the reflector 130 is arranged is arranged.
  • the surgeon brings the first site 111 and the second site 112 into contact with the tube wall Vai of the blood vessel V, so that the shaft portion 110 is brought from the tube wall Vai of the blood vessel V while performing the procedure of radiating electromagnetic waves. It can be prevented from shifting.
  • the surgeon brings the first site 111 and the second site 112 into contact with the tube wall Vai of the blood vessel V so that the first site 111 and the second site 112 are positioned parallel to each other on the cross section of the blood vessel V. It is possible to stably maintain the opposite state in the relationship.
  • each of the first portion 111 and the second portion 112 of the shaft portion 110 is substantially linear.
  • the blood vessel V abuts along the extending direction of the tube wall Vai over a predetermined length. Therefore, the holding force of the shaft portion 110 with respect to the blood vessel V can be further improved as compared with the case where a part of the shaft portion 110 is brought into point contact with the tube wall Vai of the blood vessel V.
  • the shape of the tip portion of the shaft portion 110 is changed to the first portion 111 and the second portion.
  • the curved portion 114 formed between the 112, the first portion 111 and the second portion 112 forms a substantially U-shape. Therefore, since the shaft portion 110 has a high followability to the bending of the blood vessel V, it is difficult for the holding force to the tube wall Vai to decrease due to the anatomical structure of the blood vessel V.
  • the antenna element 150 arranged in the first portion 111 and the reflector 130 arranged in the second portion 112 are also arranged in parallel with each other. Be placed. Therefore, when the electromagnetic wave is radiated from the antenna element 150, the electromagnetic wave can be more reliably reflected toward the antenna element 150 by the reflector 130 arranged in parallel with the antenna element 150. Further, since the shaft portion 110 is configured so that the first portion 111 and the second portion 112 are arranged in parallel, a catheter device in which the antenna element 150 and the reflector 130 are separately provided is delivered to the blood vessel V. The outer shape of the catheter device can be miniaturized during delivery as compared to the case of Therefore, the catheter device 100 has improved deliverability into the blood vessel V.
  • the surgeon radiates electromagnetic waves from the antenna element 150 arranged in the blood vessel V, reflects the electromagnetic waves by the reflector 130, and locally applies energy to some peripheral nerves Na that innervate the intestinal tract.
  • the surgeon can reduce the activity of the autonomic nerve of the patient's peripheral nerve Na, and can enhance the peristaltic movement of the intestinal tract.
  • the range in which energy is applied to the Vao around the origin of the superior mesenteric artery Va is, for example, 50% or less (of the blood vessel V) in the outer peripheral direction of the superior mesenteric artery Va. It is preferably in the range of 180 ° or less in the circumferential direction on the cross section).
  • the denervation range is 50% or more in the outer peripheral direction of the superior mesenteric artery Va, the enhancement of peristaltic movement after denervation may be excessively promoted. Therefore, it is preferable to denervate within the above range.
  • FIG. 13 shows an example of the temperature distribution of each region A1, A2, and A3 irradiated with the electromagnetic wave radiated from the antenna element 150 and the electromagnetic wave reflected by the reflector 130.
  • the temperature of the region A1 close to the position where the antenna element 150 is arranged on the tube wall Vai of the blood vessel V becomes the highest due to the influence of electromagnetic waves.
  • the region A2, which is farther from the antenna element 150 to the outside of the blood vessel V than the region A1 has a lower temperature after irradiation with the electromagnetic wave than the region A1.
  • the temperature of the region A3 located on the outer side of the blood vessel V with respect to the region A2 after irradiation with the electromagnetic wave is further lower than that of the region A2.
  • the peripheral nerve Na existing outside the blood vessel V can be denervated mainly by the heat energy applied to the region A1 having a temperature higher than the regions A2 and A3.
  • the arrangement of the shaft portion 110 in the blood vessel V shown in FIGS. 12 and 13 is an example.
  • the arrangement form of the shaft portion 110 in the blood vessel V is not particularly limited as long as energy (for example, electromagnetic waves) can be irradiated toward a predetermined peripheral nerve Na.
  • the catheter device 100 according to the present embodiment is used for treatment in the superior mesenteric artery Va, it is further beneficial for the following problems.
  • the superior mesenteric artery Va has an acute angle of bifurcation on the lower limb side with the aorta Vd, unlike the renal arteries VR and VL. Therefore, when delivering the catheter device 100 to the superior mesenteric artery Va, it is preferable to approach from the upper limb side.
  • a balloon or basket structure is adopted as a mechanism for holding the catheter device 100 against the tube wall Vai of the superior mesenteric artery Va from the viewpoint of reducing the diameter of the shaft portion 110. It is not appropriate to do.
  • the catheter device 100 according to the present embodiment since the first site 111 and the second site 112 can be delivered to the superior mesenteric artery Va in a substantially linearly extended state, an approach from the upper limb side is possible. It will be possible.
  • the treatment target site S is the origin near the entrance of the superior mesenteric artery Va from the viewpoint of suppressing the energy from reaching the organs as described above. It is preferable to set it in the peripheral Vao. However, when the treatment target site S is set to such a position, it is difficult to accurately position and hold the tip of the guiding catheter 300 on the Vao around the origin of the superior mesenteric artery Va, and the guiding catheter Unable to get backup by 300. In response to such a problem, in the case of the catheter device 100, as shown in FIG. 12, the first site 111 and the second site with respect to the tube wall Vai of the Vao around the origin of the superior mesenteric artery Va. By bringing the 112 into contact with each other, the holding force can be obtained by the catheter device 100 alone.
  • the superior mesenteric artery Va branches from the aorta Vd and then sharply bends toward the lower limbs and runs almost in parallel with the aorta Vd. Therefore, when a shaft portion having a spiral shape or a corrugated shape is used, a plurality of parts of the shaft portion are in point contact with the tube wall Vai of the superior mesenteric artery Va. It is not possible to obtain sufficient holding power.
  • the first site 111 and the second site 112 abut on the tube wall Vai over a relatively long range along the traveling direction of the superior mesenteric artery Va. Therefore, a sufficient holding force can be obtained.
  • the treatment is performed with the guide wire containing metal in the catheter device 100 inserted through the catheter device 100 from the viewpoint of adjusting the radiating direction of the electromagnetic wave. Is not desirable. For example, when a guide wire is used, it is necessary to remove the guide wire from the catheter device and insert the guide wire into the catheter device each time the antenna element 150 is irradiated with an electromagnetic wave.
  • the shaft portion 110 In response to such a problem, in the case of the catheter device 100, since the folded-back portion 112a is formed at the second portion 112 located at the tip portion of the shaft portion 110 in the first shape in the natural state, the shaft portion 110 The position of the tip of the shaft portion 110 within the superior mesenteric artery Va can be adjusted without damaging the duct wall Vai of the superior mesenteric artery Va by the tip. Therefore, it is not necessary to use a guide wire to guide the tip of the shaft portion 110 into the superior mesenteric artery Va, and it is possible to reduce the complexity of the procedure associated with the use of the guide wire as described above. it can.
  • the second portion 112 of the shaft portion 110 has the first shape in the blood vessel V, so that a guide wire or the like is not used. , The position of the shaft portion 110 in the blood vessel V can be easily adjusted. Further, by deforming the second portion 112 of the shaft portion 110 into the second shape in the blood vessel V, the substantially linearly extended portion of the second portion 112 is brought into contact with the tube wall Vai of the blood vessel V. Can be made to. Therefore, the holding force of the shaft portion 110 with respect to the tube wall Vai of the blood vessel V can be increased. For example, even when the shaft portion 110 is not backed up by using a guiding catheter or the like, the shaft portion is formed from the tube wall Vai of the blood vessel V. It is possible to effectively prevent the 110 from being displaced.
  • the reflector 130 is formed by a metal member (for example, a plate-shaped, tubular, or rod-shaped metal member) arranged at the second portion 112 in a state where the antenna element 150 is not energized. It is configured.
  • a metal member for example, a plate-shaped, tubular, or rod-shaped metal member
  • the reflector 130 can be made of, for example, a known metal.
  • the metal for example, copper, aluminum, stainless steel, platinum alloy, shape memory alloy and the like can be used.
  • a shape memory alloy such as a nickel titanium alloy is used from the viewpoint of maintaining the shape of the second portion 112 of the shaft portion 110 in the first shape shown in FIG. 14 in a natural state. Is more preferable.
  • FIG. 16 shows the shaft portion 110B according to the second modification.
  • the traction member 171 is connected to the antenna element 150. Therefore, the operator can push and pull the traction member 171 by moving the antenna element 150 forward and backward at hand to deform the second portion 112 into the first shape and the second shape.
  • a balun 165 can be used as a member for connecting the traction member 171 and the antenna element 150.
  • the biological lumen to be treated by the catheter device is not limited to blood vessels such as the superior mesenteric artery, the celiac artery, and the inferior mesenteric artery, but other blood vessels, the bile duct, the trachea, the esophagus, and the like. It may be the esophagus, the otolaryngal lumen, etc.
  • a catheter device is used to apply energy to the sympathetic nerve existing in the outer membrane of the renal artery of a patient by radiating energy from an energy radiating part arranged in the renal artery to lower the blood pressure of the patient. It can be configured as a device.
  • the catheter device can be configured as a device for expanding the bronchus of a patient by radiating energy from an energy radiating portion arranged in the bronchus.
  • each member included in the catheter device are not particularly limited as long as the effects of the present invention are exhibited, and are arbitrarily changed and replaced. It is possible. Further, the catheter device can appropriately add arbitrary constituent members and the like which are not particularly described in the specification, and the additional members described in the specification can be appropriately omitted. Further, any procedure not particularly described in the specification can be appropriately added to the treatment method, and the additional procedure described in the specification can be omitted as appropriate. Further, as for the treatment method, the order of the procedures can be appropriately changed as long as the effects of the invention can be exhibited.
  • first shape and the second shape formed by the second part of the shaft portion are not limited to the shapes illustrated in the drawings.
  • the suppressing member for suppressing the twisting of the shaft portion is not limited to the tubular body having a plurality of knot rings.
  • Medical device 100
  • Catheter device 110, 110A, 110B Shaft part 111 First part 112 Second part 112a Folded part 113 Base end area 114 Curved part 115 Tip tip 130 Reflector 140 Tube (suppressing member) 141, 142 Nodal ring 150 Energy radiating part (antenna element) 151 Helical element 170 Hand side operation member 171 Tow member 180 Hub 200 Controller 300 Guiding catheter Na Peripheral nerve S Treatment target site V Blood vessel (living lumen) Va Superior mesenteric artery Vai Tube wall Vb Celiac artery Vc Inferior mesenteric artery Vd Aorta

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Abstract

La présente invention vise à fournir : un dispositif de cathéter avec lequel il est possible d'augmenter la force de maintien d'une partie d'arbre dans une lumière de corps vivant et de rayonner plus précisément de l'énergie sur une zone à traiter dans la lumière de corps vivant ; et une méthode de traitement. À cet effet, l'invention concerne un dispositif de cathéter 100 qui comprend une partie de rayonnement d'énergie 150 qui peut rayonner de l'énergie dans un vaisseau sanguin V et une partie d'arbre 110 qui peut être insérée dans le vaisseau sanguin et a une première zone 111 dans laquelle au moins une partie de la partie de rayonnement d'énergie est disposée, et une seconde zone 112 qui est située sur le côté pointe de la première zone, la partie d'arbre étant déformable en une première forme dans laquelle une partie de courbure 112a qui est courbée dans la direction axiale de la partie d'arbre 110 est formée dans au moins une partie de la pointe de la seconde zone et une seconde forme dans laquelle au moins une partie de la partie de courbure 112a dans la seconde zone 112 est étendue en une ligne sensiblement droite.
PCT/JP2019/032506 2019-08-20 2019-08-20 Dispositif de cathéter et méthode de traitement WO2021033275A1 (fr)

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS50141187A (fr) * 1974-03-01 1975-11-13
JP2002191699A (ja) * 2000-12-22 2002-07-09 Terumo Corp 導入用シース位置決め器具
JP2005511135A (ja) * 2001-11-29 2005-04-28 メッドウェイブズ、インコーポレイテッド 偏向機構および操縦機構を改良した高周波ベースのカテーテルシステム
JP2011528581A (ja) * 2008-07-18 2011-11-24 バイトロナス， インコーポレイテッド エネルギー源の位置を決める方法およびシステム
JP2014516614A (ja) * 2011-04-08 2014-07-17 コビディエン エルピー 自然管腔又は人口管腔のための可撓性マイクロ波カテーテル
JP2016538054A (ja) * 2013-11-19 2016-12-08 エシコン・インコーポレイテッドＥｔｈｉｃｏｎ， Ｉｎｃ． 気管支疾患の治療のための胸腔鏡検査方法
US20170071670A1 (en) * 2014-03-12 2017-03-16 Paul Pittaluga Medical device comprising a hydrophilic curved flexible tip for the treatment of varicose veins
US20180154155A1 (en) * 2016-12-05 2018-06-07 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation devices for delivering neuromodulation energy to proximal vascular portions and distal vascular portions and associated systems and methods

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS50141187A (fr) * 1974-03-01 1975-11-13
JP2002191699A (ja) * 2000-12-22 2002-07-09 Terumo Corp 導入用シース位置決め器具
JP2005511135A (ja) * 2001-11-29 2005-04-28 メッドウェイブズ、インコーポレイテッド 偏向機構および操縦機構を改良した高周波ベースのカテーテルシステム
JP2011528581A (ja) * 2008-07-18 2011-11-24 バイトロナス， インコーポレイテッド エネルギー源の位置を決める方法およびシステム
JP2014516614A (ja) * 2011-04-08 2014-07-17 コビディエン エルピー 自然管腔又は人口管腔のための可撓性マイクロ波カテーテル
JP2016538054A (ja) * 2013-11-19 2016-12-08 エシコン・インコーポレイテッドＥｔｈｉｃｏｎ， Ｉｎｃ． 気管支疾患の治療のための胸腔鏡検査方法
US20170071670A1 (en) * 2014-03-12 2017-03-16 Paul Pittaluga Medical device comprising a hydrophilic curved flexible tip for the treatment of varicose veins
US20180154155A1 (en) * 2016-12-05 2018-06-07 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation devices for delivering neuromodulation energy to proximal vascular portions and distal vascular portions and associated systems and methods

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