WO2020250417A1 - Dispositif de cathéter et procédé de traitement - Google Patents

Dispositif de cathéter et procédé de traitement Download PDF

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Publication number
WO2020250417A1
WO2020250417A1 PCT/JP2019/023647 JP2019023647W WO2020250417A1 WO 2020250417 A1 WO2020250417 A1 WO 2020250417A1 JP 2019023647 W JP2019023647 W JP 2019023647W WO 2020250417 A1 WO2020250417 A1 WO 2020250417A1
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WIPO (PCT)
Prior art keywords
antenna element
reflector
catheter device
blood vessel
site
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PCT/JP2019/023647
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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/JP2019/023647 priority Critical patent/WO2020250417A1/fr
Publication of WO2020250417A1 publication Critical patent/WO2020250417A1/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

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).
  • Examples of the type of energy used in the above-mentioned catheter device include high-frequency current in the radio wave band, electromagnetic waves such as microwaves, and ultrasonic waves.
  • an electrode element or the like is placed in direct contact with the tube wall of the blood vessel, and by energizing with a counter electrode attached to the body surface, the outside of the blood vessel is passed through the blood vessel directly under the electrode element. It imparts heat energy to the nerves present in the body by Joule heat.
  • Treatment using radio waves affects heat energy in addition to the nerves to be treated. Therefore, there is concern about thermal damage to the intima of blood vessels, consequent stenosis of blood vessels, and embolism due to thermal coagulation of blood. Further, since the obtained temperature distribution sharply decreases as the distance from the electrode increases, it is difficult to cauterize nerves existing in a deep part at a distance of a predetermined distance or more from the tube wall of a blood vessel.
  • electromagnetic waves for example, microwaves
  • electromagnetic waves can reach nerves outside the blood vessel even when the blood vessel wall and the energy radiation source are not in contact with each other, and are compared with radio waves. It is possible to heat from the tube wall of the blood vessel to the deeper part. Therefore, by adopting an antenna element (antenna element) capable of radiating microwaves as an energy radiation source incorporated in a catheter device, it is possible to solve the above-mentioned problems that may occur when radio waves are used. Conceivable. However, when an antenna element capable of emitting electromagnetic waves is adopted as an energy radiation source incorporated in a catheter device, the following points become problems.
  • the present invention has been made based on the above-mentioned problems, and a catheter device capable of adjusting the irradiation position of electromagnetic waves by reflecting electromagnetic waves radiated from an antenna element in a predetermined direction.
  • the purpose is to provide a treatment method.
  • the catheter device has a shaft portion that can be inserted into a biological lumen, an antenna element that is arranged on the shaft portion and can radiate electromagnetic waves, and the microwave that is radiated from the antenna element.
  • the antenna element is reflective and has a reflector provided in a non-energized state.
  • the electromagnetic wave radiated from the antenna element is reflected by the reflector in a predetermined direction.
  • the operator can adjust the radiation direction of the electromagnetic wave according to the position of the reflector. Therefore, the operator can locally apply energy to the treatment target site.
  • FIG. 1 It is a figure which shows schematic the whole structure of the catheter device which concerns on 1st Embodiment. It is an enlarged perspective view which shows the tip part of the shaft part provided with the catheter device which concerns on 1st Embodiment. It is an arrow view of the shaft part seen from the direction of arrow 3A shown in FIG. It is an arrow view of the shaft part seen from the direction of arrow 4A shown in FIG. It is a flowchart which shows the procedure of the treatment method roughly. It is a figure which shows typically the blood vessel to which the treatment method is applied. It is sectional drawing which shows typically a part of the blood vessel to which the treatment method is applied.
  • FIG. 5 is a flowchart showing the procedure of the procedure using the catheter device 100.
  • 6 and 7 are diagrams for explaining the blood vessel V which is the target of the procedure using the catheter device 100.
  • 8 and 9 are diagrams for explaining a usage example of the catheter device 100. Note that FIG. 9 shows a cross section of the blood vessel V along a direction orthogonal to the traveling direction of the blood vessel V.
  • 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. 6 and 7.
  • 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) N 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 movements 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 gastrointestinal tract by the peripheral nerve Na.
  • the following points can be 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 is relative to the sympathetic nervous system and the parasympathetic nervous system. It is weakened and becomes parasympathetic dominant.
  • the enteric nervous system that autonomously controls intestinal motility in the periphery becomes dominant, and intestinal peristalsis is activated.
  • colon transit time is promoted and normalized, 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 is possible to preferably promote the relief of the symptoms of constipation with delayed colon transit time.
  • the treatment target site (range, position, etc.) 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.
  • 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.
  • an organ for example, the pancreas or duodenum located on the peripheral side of the superior mesenteric artery Va. It can be suppressed.
  • the application of energy from within the superior mesenteric artery Va is performed between the superior mesentery. It is more preferable to carry out only within the range of 0 mm to 20 mm along the extension direction of the 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 is arranged in a shaft portion 110 that can be inserted into a blood vessel V (corresponding to a “living lumen”) and a shaft portion 110, and can emit electromagnetic waves.
  • the antenna element 120 has a reflector 130 capable of reflecting electromagnetic waves radiated from the antenna element 120 and the antenna element 120 is not energized.
  • the reflector 130 can be arranged on the shaft portion 110, for example.
  • the reflector 130 reflects at least a part of the electromagnetic wave radiated from the antenna element 120 toward the side where the antenna element 120 is arranged (the side where the antenna element 120 is arranged in the cross section of the blood vessel V shown in FIG. 9).
  • the antenna element 120 can be arranged at a position different from the position where the antenna element 120 is arranged in the blood vessel V.
  • the shaft portion 110 includes a first portion 111 in which at least a part of the antenna element 120 is arranged, a second portion 112 in which at least a part of the reflector 130 is arranged, and an antenna element. It has a third site 113, which is predeterminedly shaped so that the 120 and the reflector 130 are arranged at different positions in the cross section of the blood vessel V.
  • the first site 111 and the second site 112 can be arranged so as to be in contact with the tube wall Vai of the blood vessel V at different positions of the blood vessel V.
  • the tip portion 115 of the shaft portion 110 exhibits the shapes shown in FIGS. 2 to 4 in a natural state in which no external force is applied to the shaft portion 110.
  • FIG. 8 when delivering the antenna element 120 and the reflector 130 arranged on the shaft portion 110 into the blood vessel V, the operator projects the tip portion of the shaft portion 110 from the tip opening of the guiding catheter 300. By doing so, the tip portion of the shaft portion 110 can be deformed into the habitual shape shown in FIGS. 2 to 4.
  • the specific method for shaping the shaft portion 110 is not particularly limited, and a known method for the catheter device can be appropriately adopted.
  • the first portion 111 extends substantially linearly.
  • the second portion 112 extends substantially linearly. Further, the second portion 112 extends substantially parallel to the first portion 111.
  • the third site 113 extends in a curved shape between the first site 111 and the second site 112.
  • the third portion 113 includes, for example, the first curved portion 113a located on the tip end side (the side indicated by the arrow X1) of the first portion 111 and the proximal end side (arrow X2) of the second portion 112. It can be configured to have two curved portions of the second curved portion 113b located on the side indicated by).
  • the first curved portion 113a has a shape curved so as to be folded back from the distal end side of the shaft portion 110 toward the proximal end side on the distal end side of the first portion 111. More specifically, the first curved portion 113a exhibits a shape that is convexly curved toward the tip end side of the shaft portion 110. Further, the second curved portion 113b has a shape curved so as to be folded back from the proximal end side of the shaft portion 110 toward the distal end side on the proximal end side of the second portion 112.
  • the shape of the third portion 113 may be formed by, for example, shaping a part of the shaft portion 110 itself into a predetermined shape, which will be described later.
  • the shape may be formed by a reflector 130 made of a shape memory alloy.
  • At least a part of the reflector 130 is arranged so as to face at least a part of the antenna element 120 in the natural state shown in FIG.
  • the shape of the third portion (first curved portion 113a, second curved portion 113b) 113 is at least a part of the reflector 130 arranged in the second portion 112 and the antenna element 120 arranged in the first portion 111. It is not particularly limited as long as it is possible to arrange at least a part of the blood vessel V at different positions on the cross section of the blood vessel V.
  • curvature in the present specification includes, for example, an arc shape having a predetermined radius of curvature, a shape bent at an acute angle or an obtuse angle (bending shape), and a three-dimensional shape such as a spiral shape. ..
  • the shaft portion 110 when the shaft portion 110 is arranged in the blood vessel V, at least a part of the first portion 111 in which the antenna element 120 is arranged is brought into contact with the tube wall Vai of the blood vessel V. Further, when the shaft portion 110 is arranged in the blood vessel V, at least a part of the second portion 112 in which the reflector 130 is arranged is brought into contact with the tube wall Vai of the blood vessel V. At this time, the first site 111 and the second site 112 are arranged at positions facing each other (positions facing each other with the center position O of the blood vessel V in between) in the cross section of the blood vessel V, for example, as shown in FIG. can do.
  • the operator can reflect the electromagnetic wave in a predetermined direction by the reflector 130 by radiating the electromagnetic wave from the antenna element 120 with the respective parts 111 and 112 of the shaft portion 110 arranged in the blood vessel V as described above. ..
  • the electromagnetic wave radiated from the antenna element 120 is irradiated to the side where the antenna element 120 is arranged (upper side in FIG. 9) on the cross section of the blood vessel V.
  • the electromagnetic wave reflected by the reflector 130 is also irradiated toward the side where the antenna element 120 is arranged on the cross section of the blood vessel V.
  • the operator can suppress the electromagnetic wave from spreading and being radiated to the side where the reflector 130 is arranged on the cross section of the blood vessel V. Therefore, the operator can locally irradiate the surrounding nerve Na existing outside the blood vessel V on the side where the antenna element 120 is arranged with an electromagnetic wave.
  • 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. Further, the outer diameter of the shaft portion 110, the length in the axial direction, the size of the lumen of the shaft portion 110, the cross-sectional shape, and the like are not particularly limited.
  • a tapered tip tip whose outer diameter gradually decreases toward the tip side can be attached to the tip of the shaft portion 110.
  • the tip tip can be made of, for example, a flexible resin material.
  • the shaft portion 110 can be configured to have a multi-lumen structure including a lumen through which a guide wire and various media can pass in addition to the lumen in which the antenna element 120 is arranged.
  • a port for communicating inside and outside the shaft portion 110 may be 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. it can.
  • the antenna element 120 can be configured to have, for example, a helical element 121 capable of radiating microwaves as an electromagnetic wave.
  • the reflector 130 is arranged inside the shaft portion 110, and can be composed of a metal member extending with a predetermined length along the extending direction of the shaft portion 110.
  • the center frequency of the antenna element 120 can be set to, for example, 915 MHz, 2.45 GHz, 5.8 GHz, or 24.125 GHz.
  • a coaxial cable 140 is arranged inside the shaft portion 110.
  • the tip of the coaxial cable 140 is not covered with the outer conductor, and the inner conductor (center conductor) 141 and the dielectric (not shown) are led out to the tip side by a predetermined length.
  • a connecting portion 143 is arranged at the tip of the inner conductor 141.
  • the tip of the helical element 121 is electrically connected to the connecting portion 143 to form a helical antenna.
  • a balun 145 that converts an electric signal in a balanced and unbalanced state is arranged on the coaxial cable 140.
  • the antenna element 120 radiates electromagnetic waves by receiving an electric current via the coaxial cable 140.
  • the antenna element 120 is composed of a structure (helical element 121, internal conductor 141, connection portion 143) located on the tip side of the portion of the internal conductor 141 protruding from the coaxial cable 140.
  • the structure, shape, frequency and material of the radiated electromagnetic wave, the arrangement form of the shaft portion 110, and the like are not particularly limited as long as each structure constituting the antenna element 120 can radiate electromagnetic waves.
  • the spiral winding direction of the helical element 121 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 121 is not particularly limited.
  • the helical element 121 can be made of, for example, a platinum alloy.
  • the reflector 130 can be arranged at the second portion 112 away from the first portion 111 where the antenna element 120 is arranged. By arranging the reflector 130 away from the antenna element 120, the reflector 130 is arranged on the shaft portion 110 together with the antenna element 120, while maintaining a non-energized state that is not electrically connected to the antenna element 120. be able to.
  • 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 from the viewpoint of maintaining the shape of the tip portion 115 of the shaft portion 110 in the shape shown in FIG.
  • 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 120 is arranged so that the radiation characteristics of the electromagnetic waves radiated from the antenna element 120 are not significantly impaired. It is preferable that the antenna is not arranged in the entire circumferential direction and the axial direction.
  • the reflector 130 is arranged at the first end portion 131 arranged at the first curved portion 113a, the second end portion 132 arranged at the second curved portion 113b, and the second portion 112. It has a third site 133 and the like.
  • the reflector 130 can be made of, for example, a metal wire having a circular cross section.
  • the reflector 130 is not particularly limited in material, cross-sectional shape, length, number of installations, and the like as long as it can reflect electromagnetic waves radiated from the antenna element 120 in a predetermined direction.
  • the reflector 130 can also be made of, for example, a resin material or the like plated with metal.
  • the reflector 130 is arranged so as to be able to reflect the electromagnetic wave radiated from the antenna element 120 arranged at the first portion 111 of the shaft portion 110 toward the antenna element 120.
  • the reflector 130 can be arranged at the second portion 112 which is arranged so as to face the first portion 111.
  • the reflector 130 can be fixedly arranged on the inner surface of the shaft portion 110.
  • the structure of the reflector 130 is not particularly limited, and may be composed of, for example, a spiral-shaped reflector, a flat plate-shaped reflector, a plurality of individually separated reflector groups instead of one continuous member, and the like.
  • the specific method for fixing the reflector 130 to the shaft portion 110 is not particularly limited.
  • the reflector 130 may be arranged in part or in whole outside the shaft portion 110, or may be arranged so that a gap is provided in the lumen of the shaft portion 110 embedded in the pipe wall of the shaft portion 110. It may be arranged so as to fill the lumen of the shaft portion 110.
  • the reflector 130 can be shaped in advance to the shape shown in FIG.
  • the first curved portion 113a of the shaft portion 110 has a curved shape in the vicinity of the first end portion 131 of the reflector 130, so that the first curved portion 113a is folded back from the tip end side to the base end side in accordance with the shape of the first end portion 131. It has a curved shape.
  • the second curved portion 113b of the shaft portion 110 has a shape in which the vicinity of the second end portion 132 of the reflector 130 is curved, so that the second curved portion 113b follows the shape of the second end portion 132 from the base end side to the tip end side. It has a curved shape.
  • the second portion 112 of the shaft portion 110 extends substantially linearly following the shape of the third portion 133 of the reflector 130 extending substantially linearly.
  • the emission of electromagnetic waves by the antenna element 120 can be controlled via, for example, a predetermined controller (control device) 200.
  • the controller 200 can be electrically connected to the coaxial cable 140, for example, via an electric wire led out from a hub 150 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 120 for example, a wired one via a telecommunication line, a wireless one not via a telecommunication line, an operator via an operation unit incorporated in the controller, or the like.
  • the treatment using the antenna element 120 may be performed by, for example, a medical device such as a treatment robot that substitutes the work by the operator.
  • 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. be able to.
  • 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 is to deliver the catheter device 100 into the blood vessel V (S11) and at least one of the first site 111 of the shaft portion 110 on which the antenna element 120 is arranged. At least a part of the second portion 112 of the shaft portion 110 on which the portion and the reflector 130 are arranged is brought into contact with the tube wall Vai of the blood vessel V (S12), and the electromagnetic wave radiated from the antenna element 120 and the electromagnetic wave reflected by the reflector 130. Irradiates the surrounding nerve Na existing outside the blood vessel V (S13).
  • the operator uses a known guiding catheter 300 to deliver the catheter device 100 to the blood vessel V.
  • the catheter device 100 is deformed into the shape shown in FIG. 2 when the tip portion 115 of the shaft portion 110 protrudes by a predetermined length from the tip opening of the guiding catheter 300.
  • the operator visits the first site where the antenna element 120 is arranged at a position facing each other on the cross section of the blood vessel V (a position having an angle difference of 180 ° in the circumferential direction of the blood vessel V).
  • a second portion 112 in which the 111 and the reflector 130 are arranged is arranged.
  • the surgeon arranges the shaft portion 110 in contact with the tube wall Vai of the blood vessel V while performing the procedure of radiating electromagnetic waves. It is possible to prevent deviation from Vai.
  • the operator arranges the first site 111 and the second site 112 in contact with the tube wall Vai of the blood vessel V so that the first site 111 and the second site 112 are parallel to each other on the cross section of the blood vessel V. It is possible to stably maintain the facing state in a proper positional relationship.
  • each of the first portion 111 and the second portion 112 of the shaft portion 110 extends substantially linearly.
  • a comparison is made with the case where a part of the shaft portion 110 is point-contacted with the blood vessel V tube wall Vai. Therefore, the holding force of the shaft portion 110 with respect to the blood vessel V can be further improved.
  • the antenna element 120 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 120, the electromagnetic wave can be more reliably reflected toward the antenna element 120 by the reflector 130 arranged in parallel with the antenna element 120. 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 120 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 120 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. 9 shows an example of the temperature distribution of each region A1, A2, and A3 irradiated with the electromagnetic wave emitted from the antenna element 120 and the electromagnetic wave reflected by the reflector 130.
  • the temperature of the region A1 close to the position where the antenna element 120 is arranged becomes the highest due to the influence of electromagnetic waves.
  • the region A2, which is farther from the antenna element 120 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. 8 and 9 is an example.
  • the arrangement form of the shaft portion 110 in the blood vessel V is not particularly limited as long as it can irradiate an electromagnetic wave toward a predetermined peripheral nerve Na.
  • the catheter device 100 is arranged on the shaft portion 110 that can be inserted into the blood vessel V and the shaft portion 110, and is radiated from the antenna element 120 that can radiate electromagnetic waves and the antenna element 120.
  • the antenna element 120 has a reflector 130 that is not energized and is capable of reflecting the electromagnetic waves.
  • the electromagnetic wave radiated from the antenna element 120 is reflected by the reflector 130 in a predetermined direction.
  • the operator can adjust the radiation direction of the electromagnetic wave according to the position of the reflector 130. Therefore, the operator can locally apply energy to the treatment target site S in which the peripheral nerve Na is present.
  • the reflector 130 is arranged on the shaft portion 110, and the position where the antenna element 120 is arranged in the blood vessel V so as to reflect at least a part of the electromagnetic wave toward the side where the antenna element 120 is arranged. It is configured so that it can be placed at a different position from. Therefore, the operator radiates the electromagnetic wave from the antenna element 120 with the shaft portion 110 arranged in the blood vessel V, so that the direction in which the electromagnetic wave is irradiated is the side in which the antenna element 120 is arranged in the cross section of the blood vessel V. Can be suitably adjusted to.
  • the shaft portion 110 has a first portion 111 in which the antenna element 120 is arranged, a second portion 112 in which at least a part of the reflector 130 is arranged, and the antenna element 120 and the reflector 130 in a cross section of the blood vessel V. It has a third site 113, which is shaped so as to be arranged at different positions, and the first site 111 and the second site 112 are located at different positions of the blood vessel V from each other. It is configured so that it can be placed in contact with the antenna. Therefore, the operator brings the first portion 111 of the shaft portion 110 and the second portion 112 of the shaft portion 110 into contact with the tube wall Vai of the blood vessel V, and radiates electromagnetic waves in a state where both positions are determined. be able to.
  • the first site 111 extends substantially linearly
  • the second site 112 extends substantially parallel to the first site 111
  • the third site 113 extends to the first site 111 and the second site. It extends in a curved shape with 112. Therefore, when the operator radiates the electromagnetic wave from the antenna element 120 in the blood vessel V, the surgeon can more reliably reflect the electromagnetic wave toward the antenna element 120 by the reflector 130 arranged in parallel with the antenna element 120.
  • 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 120 and the reflector 130 are separately provided is delivered to the blood vessel V. The shape of the shaft portion 110 during delivery can be reduced in size as compared with the case of
  • the reflector 130 is made of a shape memory alloy arranged on the shaft portion 110.
  • the reflector 130 has a function of reflecting an electromagnetic wave radiated from the antenna element 120 in a predetermined direction and a function of shaping the shaft portion 110 into a predetermined shape. Therefore, by shaping the reflector 130 in advance, the shape of the shaft portion 110 can be easily deformed in the blood vessel V. Further, since the shaft portion 110 can be shaped by the reflector 130, the work load required for the shaping work of the catheter device 100 can be reduced.
  • the third portion 113 of the shaft portion 110 has a first curved portion 113a that is convexly curved toward the tip end side of the shaft portion 110. Therefore, the surgeon can easily arrange each of the first site 111 and the second site 112 at different positions on the cross section of the blood vessel V by the shaped first curved portion 113a.
  • the third portion 113 of the shaft portion 110 is arranged so that at least a part of the first portion 111 and at least a part of the second portion 112 are in contact with the tube wall Vai of the Vao around the origin of the blood vessel V. It is shaped like this. Therefore, the operator can arrange the first site 111 and the second site 112 in contact with the tube wall Vai of the Vao around the origin of the blood vessel V, and the antenna element 120 and the antenna element 120 for the Vao around the origin can be arranged. Positioning and holding of the reflector 130 can be easily realized. In addition, the operator can suppress the transfer of heat energy to the peripheral side of the blood vessel V by performing the treatment in the Vao around the origin of the blood vessel V.
  • the antenna element 120 has a helical element 121 capable of radiating microwaves as an electromagnetic wave. Therefore, by adjusting the number of turns of the helical element 121, the length of the helical element 121 in the major axis direction can be shortened while maintaining the current path of the helical element 121. Further, the resonance frequency can be easily adjusted according to the number of turns of the helical element 121.
  • the catheter device 100 radiates from an antenna element 120 arranged in at least one blood vessel V of the superior mesenteric artery Va, the celiac artery Vb, and the inferior mesenteric artery Vc as a biological lumen to be treated. It is configured as a device capable of enhancing the peristaltic movement of the intestinal tract by reflecting electromagnetic waves by the reflector 130 and applying energy to the surrounding nerve Na that innervates the intestinal tract to reduce the activity of the autonomic nerves. .. Therefore, the surgeon can preferably promote the relief of the patient's constipation symptoms by performing the procedure using the catheter device 100.
  • the catheter device 100 at least a part of the reflector 130 is arranged in the blood vessel V so as to face the antenna element 120. Therefore, the electromagnetic wave reflected by the reflector 130 can be more reliably reflected toward the antenna element 120 side, and the peripheral nerve Na located on the antenna element 120 side can be efficiently denervated.
  • the antenna element 120 which is arranged on the shaft portion 110 and can radiate electromagnetic waves and the antenna element 120 are provided in a non-energized state and can reflect the electromagnetic waves radiated from the antenna element 120.
  • the antenna element 120 Including the insertion of the catheter device 100 including the 130 into the blood vessel V, and the reflection of the electromagnetic waves by the reflector 130 in a predetermined direction in the cross section of the blood vessel V while radiating the electromagnetic waves from the antenna element 120. ..
  • the electromagnetic wave radiated from the antenna element 120 can be reflected by the reflector 130 in a predetermined direction.
  • the operator can adjust the radiation direction of the electromagnetic wave according to the position of the reflector 130. Therefore, the operator can locally apply energy to the treatment target site S in which the peripheral nerve Na is present.
  • the above-mentioned treatment method is carried out in at least one blood vessel V of the superior mesenteric artery Va, the celiac artery Vb, and the inferior mesenteric artery Vc. Then, in the above treatment method, the electromagnetic wave radiated from the antenna element 120 arranged in the blood vessel V is reflected by the reflector 130, and energy is given to the surrounding nerve Na that innervates the intestinal tract to reduce the activity of the autonomic nerve. This enhances the peristaltic movement of the intestinal tract. Therefore, by carrying out the above-mentioned treatment method, it is possible to preferably promote the relief of the symptoms of constipation in the patient.
  • the reflector 130 is arranged in the blood vessel V so as to face the antenna element 120, and at least a part of the electromagnetic wave is directed toward the side where the antenna element 120 is arranged in the cross section of the blood vessel V by the reflector 130. Reflect. Therefore, the electromagnetic wave reflected by the reflector 130 can be more reliably reflected toward the antenna element 120 side, and the peripheral nerve Na located on the antenna element 120 side can be efficiently denervated.
  • the shaft portion 110 has a first portion 111 in which at least a part of the antenna element 120 is arranged, a second portion 112 in which at least a part of the reflector 130 is arranged, and a blood vessel V of the antenna element 120 and the reflector 130. It has a third portion 113, which is predeterminedly shaped so as to be arranged at different positions in the cross section of the above.
  • at least a part of the first site 111 and at least a part of the second site 112 are brought into contact with the tube wall Vai of the blood vessel V at different positions in the cross section of the blood vessel V.
  • the electromagnetic wave is reflected by the reflector 130. Therefore, the operator brings the first portion 111 of the shaft portion 110 and the second portion 112 of the shaft portion 110 into contact with the tube wall Vai of the blood vessel V, and radiates electromagnetic waves in a state where both positions are determined. be able to.
  • the operator can arrange the first site 111 and the second site 112 in contact with the tube wall Vai of the Vao around the origin of the blood vessel V, and the antenna element 120 and the antenna element 120 for the Vao around the origin can be arranged. Positioning and holding of the reflector 130 can be easily realized.
  • the operator can suppress the transfer of heat energy to the peripheral side of the blood vessel V by performing the treatment in the Vao around the origin of the blood vessel V.
  • ⁇ Second Embodiment> 10 to 13 show the tip 115 of the shaft portion 110A of the catheter device according to the second embodiment.
  • the shaft portion 110A exhibits the shapes shown in FIGS. 10 to 12 in a natural state where no external force is applied.
  • the shaft portion 110A of the catheter device according to the second embodiment includes a first portion 111 in which at least a part of the antenna element 120 is arranged, a second portion 112 in which at least a part of the reflector 130 is arranged, and an antenna element 120. And a third site 113, which is predeterminedly shaped so that the reflector 130 is arranged at different positions in the cross section of the blood vessel V.
  • the first part 111 extends substantially linearly.
  • the second portion 112 has a first straight portion 112a extending substantially parallel to the first portion 111 and a second straight portion 112b extending substantially parallel to the first portion 111 and the first straight portion 112a. And have.
  • the third portion 113 has a shape curved between the first portion 111 and the first straight portion 112a, and a curved shape between the first straight portion 112a and the second straight portion 112b. It has a second curved portion 113b and the like.
  • the reflector 130 is located between the first end portion 131 arranged in the first curved portion 113a, the second end portion 132 arranged in the second straight line portion 112b, and the first end portion 131 and the second end portion 132. It has a first extending portion 133a, a second extending portion 133b, and a third extending portion 133c extending to.
  • the first extending portion 133a is arranged in the first straight portion 112a.
  • the second extending portion 133b is arranged in the second straight line portion 112b.
  • the third extending portion 133c is arranged in the second curved portion 113b.
  • each of the first portion 111, the first straight portion 112a, and the second straight portion 112b of the shaft portion 110A is arranged in parallel. Further, as shown in the front view of FIG. 13, the first straight portion 112a and the second straight portion 112b are formed on the first portion 111 by the first curved portion 113a and the second curved portion 113b having a predetermined shape. It is placed at the opposite position.
  • Each of the first straight line portion 112a and the second straight line portion 112b is arranged at a predetermined distance from each other. As shown in FIG. 13, each of the first portion 111, the first straight portion 112a, and the second straight portion 112b is based on the geometric center position of the three (corresponding to the center position O of the blood vessel V). For example, it is possible to arrange them with an angle difference of 120 °. However, the specific numerical value of the above angle difference is not particularly limited.
  • the first straight line portion 112a and the second straight line portion 112b of the shaft portion 110A are cross-sectionally cross-sectional to the tube wall Vai of the blood vessel V. Place in different positions. Further, the first portion 111 on which the antenna element 120 is arranged can be arranged at a position on the cross section of the blood vessel V opposite to the linear portions 112a and 112b in the circumferential direction.
  • the surgeon can radiate an electromagnetic wave from the antenna element 120 with the shaft portion 110A arranged in the blood vessel V as described above, so that the electromagnetic wave is reflected by the reflectors 130 arranged in the linear portions 112a and 112b. it can.
  • the electromagnetic wave radiated from the antenna element 120 irradiates the surrounding nerve Na existing outside the blood vessel V on the antenna element 120 side.
  • the catheter device according to the present embodiment as shown in FIG. 15, since electromagnetic waves can be reflected by two portions 133a and 133b of the reflector 130 arranged at different positions on the cross section of the blood vessel V, the reflector 130 Therefore, the electromagnetic wave can be more reliably reflected to the antenna element 120 side.
  • the shaft portion 110A is connected to the tube of the blood vessel V. It becomes possible to hold the wall Vai more stably.
  • the surgeon arranges the first site 111 and the second site (first straight section 112a, second straight section 112b) 112 in contact with the tube wall Vai of Vao around the origin of the blood vessel V. Therefore, the positioning and holding of the antenna element 120 and the reflector 130 with respect to the Vao around the starting portion can be easily realized.
  • the operator can suppress the transfer of heat energy to the peripheral side of the blood vessel V by performing the treatment in the Vao around the origin of the blood vessel V.
  • FIG. 16 shows an example of using the catheter device according to the third embodiment.
  • the shaft portion 110A of the catheter device according to the third embodiment exhibits a substantially U-shape shown in FIG. 16 in a natural state to which no external force is applied.
  • the shaft portion 110B includes a first portion 111 in which at least a part of the antenna element 120 is arranged, a second portion 112 in which at least a part of the reflector 130 is arranged, and a third portion 113 having a predetermined shape.
  • a fourth site 114 which is formed on the distal end side of the third site 113 and holds the positions of the first site 111 and the second site 112 by contacting the tube wall Vai of the blood vessel V.
  • the first portion 111 extends so as to project diagonally from the base end side to the tip end side of the shaft portion 110B.
  • the second portion 112 extends so as to project obliquely from the tip end side to the base end side of the shaft portion 110B.
  • the third site 113 extends in a curved shape between the first site 111 and the second site 112.
  • the first site 111 and the second site 112 of the shaft portion 110B are arranged at different positions in the cross section of the tube wall Vai of the blood vessel V. ..
  • the first site 111 and the second site 112 are arranged in contact with the tube wall Vai of the blood vessel V, they are arranged substantially parallel to each other in a linearly extending state following the shape of the tube wall Vai.
  • the operator can radiate the electromagnetic wave from the antenna element 120 with the shaft portion 110B arranged in the blood vessel V as described above, so that the electromagnetic wave can be reflected by the reflector 130 arranged at the second portion 112.
  • the electromagnetic wave radiated from the antenna element 120 irradiates the surrounding nerve Na existing outside the blood vessel V on the antenna element 120 side.
  • the shaft portion 110B is formed in a substantially U-shape, the shaping work of the shaft portion 110B with respect to the third portion 113 becomes simple. Therefore, the manufacture of the catheter device becomes easy.
  • the guiding catheter 300 when the treatment is performed in the Vao around the origin of the blood vessel V as in the treatment method according to the present embodiment, when the tip of the guiding catheter 300 is inserted into the blood vessel V, the guiding catheter 300 becomes a shaft. It interferes with the unit 110 and the antenna element 120. However, if the tip of the guiding catheter is left in the aorta Vd, the blood vessel V cannot be confirmed by angiography, and it is not easy to grasp the state of Vao around the origin. Therefore, it becomes difficult for the operator to stably hold the first portion 111 and the second portion 112 of the shaft portion 110 on the Vao around the origin portion.
  • the shaft portion 110 has the shaped fourth portion 114 to prevent the antenna element 120 from advancing too far to the periphery of the blood vessel V, and starts.
  • the positioning and holding of the antenna element 120 and the reflector 130 with respect to the peripheral Vao can be easily realized.
  • the blood vessel V to be treated is the superior mesenteric artery Va
  • the operator can see the boundary Vae between the aorta Vd and the superior mesenteric artery Va (superior mesenteric artery Va).
  • the fourth portion 114 can be placed in contact with the edge of the opening).
  • a part of the reflector 130 made of a shape memory alloy is arranged in a part of the fourth part 114, so that the fourth part 114 is the blood vessel V while maintaining the shape shown in FIG. The state of being in contact with the boundary portion Vae of the above can be stably maintained.
  • the fourth portion 114 is the fourth portion.
  • a marker portion (for example, an X-ray contrast marker) can be provided so that the operator or the like can confirm the position and shape of the 114 in the blood vessel V.
  • FIG. 17 shows the tip portion 115 of the shaft portion 110C of the catheter device according to the fourth embodiment.
  • a part of the shaft portion 110C is bifurcated near the tip portion 115.
  • One of the bifurcated sides of the shaft portion 110C constitutes a first portion 111 in which at least a part of the antenna element 120 is arranged.
  • the other side of the shaft portion 110C bifurcated constitutes a second portion 112 in which at least a part of the reflector 130 is arranged.
  • a predetermined shape is formed so that the first site 111 and the second site 112 are arranged at different positions on the cross section of the blood vessel V. It constitutes the third part 113. As shown in FIG.
  • the first portion 111 and the second portion 112 extend substantially linearly and extend substantially parallel to each other in a natural state to which no external force is applied. Even in the procedure using the catheter device having a configuration such as the shaft portion 110C according to the present embodiment, the electromagnetic wave radiated from the antenna element 120 in the blood vessel V is reflected by the reflector 130 and exists outside the blood vessel V. Electromagnetic waves can be locally applied to the surrounding nerve Na.
  • the structure of the shaft portion of the catheter device described in the first to fourth embodiments described above is an example, and is not limited to these contents.
  • the shaft portion may have a structure in which at least the antenna element and the reflector are arranged.
  • the shaft portion may be provided with one or more portions corresponding to the second portion on which the reflector 130 is arranged, and is limited to the configuration having one or two second portions described in the embodiment.
  • the second portion may be provided with three or more.
  • the shaft portion is formed, for example, in a shape wound in a spiral shape or other shape, and has a structure in which the antenna element and the reflector are arranged at different positions in the cross section of the biological lumen. You may be doing it.
  • the antenna element and / or the reflector may not be arranged in the linear portion of the shaft portion.
  • FIG. 18 shows the catheter device 400A according to the fifth embodiment.
  • the catheter device 400A according to the fifth embodiment is composed of a balloon catheter.
  • the shaft portion 110 is inserted inside the balloon 410.
  • the reflector 430 can be arranged, for example, so that a part of the reflector 430 comes into contact with the outer surface of the balloon 410.
  • the catheter device 400A can reflect the electromagnetic wave radiated from the antenna element 120 in a predetermined direction by the reflector 430.
  • the specific shape, arrangement, mounting method, etc. of the reflector 430 are not particularly limited.
  • FIG. 19 shows the catheter device 400B according to the sixth embodiment.
  • the catheter device 400B according to the sixth embodiment is composed of a balloon catheter.
  • the reflector 430 can be composed of, for example, a plurality of metal members fixed to the outer surface of the balloon 410.
  • the catheter device 400B can reflect the electromagnetic wave radiated from the antenna element 120 in a predetermined direction by the reflector 430.
  • the specific shape, arrangement, mounting method, etc. of the reflector 430 are not particularly limited.
  • FIG. 20 shows the catheter device 500A according to the seventh embodiment.
  • the reflector 530 is arranged on the support member 520 connected to the shaft portion 110.
  • the support member 520 can be made of, for example, a known resin material.
  • the reflector 530 is arranged inside the support member 520.
  • the catheter device 500A can reflect the electromagnetic wave radiated from the antenna element 120 in a predetermined direction by the reflector 530.
  • the specific shape, arrangement, mounting method, etc. of the support member 520 and the reflector 430 are not particularly limited.
  • FIG. 21 shows the catheter device 500B according to the eighth embodiment.
  • the catheter device 500B according to the eighth embodiment is configured by a basket structure 530 connected to the shaft portion 110.
  • the basket structure 530 can be made of a shape memory alloy such as a nickel titanium alloy.
  • the catheter device 500B can reflect the electromagnetic wave radiated from the antenna element 120 in a predetermined direction by the basket structure 530.
  • the specific shape, arrangement, mounting method, material, etc. of the basket structure 530 are not particularly limited.
  • the present invention comprises an antenna element capable of radiating electromagnetic waves and a reflector capable of reflecting electromagnetic waves radiated from the antenna element in a predetermined direction.
  • an antenna element capable of radiating electromagnetic waves
  • a reflector capable of reflecting electromagnetic waves radiated from the antenna element in a predetermined direction.
  • the biological lumen to be treated by the catheter device is not limited to blood vessels such as the superior mesenteric artery, celiac artery, and inferior mesenteric artery, but other blood vessels, bile ducts, trachea, esophagus, and the like. It may be the urinary tract, the otolaryngology, or the like.
  • a catheter device is a device for lowering a patient's blood pressure by radiating electromagnetic waves from an antenna element placed in the renal artery to apply energy to the sympathetic nerve existing in the adventitia of the patient's renal artery. It can be configured as.
  • the catheter device is configured as a device for radiating electromagnetic waves from an antenna element placed in the bronchus to apply energy to nerves around the patient's bronchus and expand the patient's bronchus. It is also possible to do.
  • 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.

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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Electromagnetism (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Otolaryngology (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Le problème décrit par la présente invention est de fournir : un dispositif de cathéter de telle sorte que la position d'irradiation d'ondes électromagnétiques émises à partir d'un élément d'antenne peut être ajustée par réflexion des ondes électromagnétiques dans une direction prédéterminée ; et un procédé de traitement. La solution selon l'invention porte sur un dispositif de cathéter (100) qui comprend : une partie d'arbre (110) qui peut être insérée dans un vaisseau sanguin V ; un élément d'antenne (120) qui est disposé dans la partie d'arbre et qui est apte à émettre des ondes électromagnétiques ; et un réflecteur (130) qui est apte à réfléchir les ondes électromagnétiques émises à partir de l'élément d'antenne et qui n'est pas conducteur avec l'élément d'antenne.
PCT/JP2019/023647 2019-06-14 2019-06-14 Dispositif de cathéter et procédé de traitement WO2020250417A1 (fr)

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PCT/JP2019/023647 WO2020250417A1 (fr) 2019-06-14 2019-06-14 Dispositif de cathéter et procédé de traitement

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012506300A (ja) * 2008-10-21 2012-03-15 マイクロキューブ， エルエルシー 身体組織にエネルギーに印加する方法および装置
JP2013544565A (ja) * 2010-10-20 2013-12-19 メドトロニック アーディアン ルクセンブルク ソシエテ ア レスポンサビリテ リミテ 腎神経調節のための拡張可能なメッシュ構造を有するカテーテル器具並びに関連するシステムおよび方法

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012506300A (ja) * 2008-10-21 2012-03-15 マイクロキューブ， エルエルシー 身体組織にエネルギーに印加する方法および装置
JP2013544565A (ja) * 2010-10-20 2013-12-19 メドトロニック アーディアン ルクセンブルク ソシエテ ア レスポンサビリテ リミテ 腎神経調節のための拡張可能なメッシュ構造を有するカテーテル器具並びに関連するシステムおよび方法

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